|
| VAERS ID: |
953098 (history)
|
| Form: |
Version 2.0 |
| Age: |
|
| Sex: |
Female |
| Location: |
Unknown |
| Vaccinated: | 2021-01-10 |
| Onset: | 2021-01-01 |
| Submitted: |
0000-00-00 |
| Entered: |
2021-01-18 |
| Vaccination / Manufacturer |
Lot / Dose |
Site / Route |
| COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH |
- / 1 |
- / - |
Administered by: Unknown Purchased by: ?
Symptoms: Rash,
Skin exfoliation,
Stevens-Johnson syndrome
SMQs:, Severe cutaneous adverse reactions (narrow), Anaphylactic reaction (broad), Oropharyngeal conditions (excl neoplasms, infections and allergies) (narrow), Hypersensitivity (narrow), Drug reaction with eosinophilia and systemic symptoms syndrome (broad), Immune-mediated/autoimmune disorders (broad)
Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type: USPFIZER INC2021017792
Write-up: Stevens Johnson Syndrome; rash was starting to peel; developed a rash all over her neck/ the rash has spread to face eyes, cheek; developed a rash all over her neck, "looks like its peeling and taut"; developed a rash all over her neck, "looks like its peeling and taut"; This is a spontaneous report from a contactable nurse (patient). A female patient of an unspecified age (Age: 48, Unit unknown) received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration on 10Jan2021 at single dose for covid-19 immunization. Medical history included she had an allergic reaction to sulfa and developed Stevens Johnson syndrome from an unknown date and unknown if ongoing. The patient's concomitant medications were not reported. The patient experienced Stevens Johnson Syndrome, developed a rash all over her neck/ the rash has spread to face eyes, cheek; "looks like its peeling and taut"; and the rash was starting to peel, all in Jan2021. The patient received 1st dose of vaccine on 10Jan2021, developed a rash all over her neck, "looks like its peeling and taut". She had an allergic reaction to sulfa and developed Stevens Johnson syndrome, this looks similar to that (Experience of Stevens Johnson Syndrome). The patient was asking if she did take the steroid dose pack from her dermatologist for the skin rash will it prohibit her from taking the second dose of the vaccine. She called yesterday and reported a rash after receiving the first dose of the COVID-19 vaccine. She stated that she went to her Dermatologist this morning because the rash has spread to face eyes, cheek and the rash was starting to peel. She stated that the dermatologist wanted to know if it was safe to treat her with a prednisone dose pack after receiving the vaccine. Her rash was worsening so she went to her dermatologist for treatment. She was asking if she should get the second dose. The outcome of events for developed a rash all over her neck/ the rash has spread to face eyes, cheek was not resolved, for other events was unknown. Information about lot/batch number has been requested.; Sender's Comments: A possible causal association between administration of BNT162B2 and the onset of suspect Stevens Johnson Syndrome presented as skin reactions cannot be excluded, considering the plausible temporal relationship. Severe allergic reaction is the known risk for the vaccine. The underlying predisposing condition of an allergic reaction to sulfa developed Stevens Johnson syndrome may put the patient at high risk of the similar occurrence. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to Regulatory Authorities, Ethics Committees and Investigators, as appropriate |
|
| VAERS ID: |
955792 (history)
|
| Form: |
Version 2.0 |
| Age: |
|
| Sex: |
Male |
| Location: |
Foreign |
| Vaccinated: | 2020-12-22 |
| Onset: | 2020-12-01 |
| Submitted: |
0000-00-00 |
| Entered: |
2021-01-19 |
| Vaccination / Manufacturer |
Lot / Dose |
Site / Route |
| COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH |
- / UNK |
- / OT |
Administered by: Other Purchased by: ?
Symptoms: Anaphylactic reaction,
Angioedema,
Blood culture,
Coma scale abnormal,
Depressed level of consciousness,
Dyspnoea,
Hypotension,
Hypothermia,
Malaise,
Multiple organ dysfunction syndrome,
Oxygen saturation decreased,
Pruritus,
Rash,
Rash maculo-papular,
Skin exfoliation,
Stevens-Johnson syndrome,
Swelling face,
Toxic epidermal necrolysis
SMQs:, Severe cutaneous adverse reactions (narrow), Anaphylactic reaction (narrow), Angioedema (narrow), Hyperglycaemia/new onset diabetes mellitus (broad), Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Shock-associated circulatory or cardiac conditions (excl torsade de pointes) (broad), Torsade de pointes, shock-associated conditions (broad), Hypovolaemic shock conditions (broad), Toxic-septic shock conditions (broad), Anaphylactic/anaphylactoid shock conditions (narrow), Hypoglycaemic and neurogenic shock conditions (broad), Oropharyngeal allergic conditions (narrow), Oropharyngeal conditions (excl neoplasms, infections and allergies) (narrow), Acute central respiratory depression (broad), Pulmonary hypertension (broad), Noninfectious encephalitis (broad), Noninfectious encephalopathy/delirium (broad), Noninfectious meningitis (broad), Accidents and injuries (broad), Cardiomyopathy (broad), Hypotonic-hyporesponsive episode (broad), Generalised convulsive seizures following immunisation (broad), Hypersensitivity (narrow), Respiratory failure (broad), Drug reaction with eosinophilia and systemic symptoms syndrome (broad), Hypoglycaemia (broad), Infective pneumonia (broad), Dehydration (broad), Hypokalaemia (broad), Sepsis (broad), Immune-mediated/autoimmune disorders (broad)
Life Threatening? No
Birth Defect? No
Died? Yes
Date died: 2020-12-29
Days after onset: 28
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? Yes, ? days
Extended hospital stay? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type:
Write-up: |
|
| VAERS ID: |
999851 (history)
|
| Form: |
Version 2.0 |
| Age: |
52.0 |
| Sex: |
Male |
| Location: |
Foreign |
| Vaccinated: | 2021-01-13 |
| Onset: | 2021-01-13 |
| Days after vaccination: | 0 |
| Submitted: |
0000-00-00 |
| Entered: |
2021-02-04 |
| Vaccination / Manufacturer |
Lot / Dose |
Site / Route |
| COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH |
EJ3002 / 1 |
LA / OT |
Administered by: Other Purchased by: ?
Symptoms: Abdominal pain,
Dizziness,
Nausea,
Pain,
Stevens-Johnson syndrome,
Tachycardia,
Vaccination site pain
SMQs:, Severe cutaneous adverse reactions (narrow), Acute pancreatitis (broad), Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Arrhythmia related investigations, signs and symptoms (broad), Retroperitoneal fibrosis (broad), Oropharyngeal conditions (excl neoplasms, infections and allergies) (narrow), Gastrointestinal nonspecific symptoms and therapeutic procedures (narrow), Vestibular disorders (broad), Hypersensitivity (narrow), Drug reaction with eosinophilia and systemic symptoms syndrome (broad), Dehydration (broad), Immune-mediated/autoimmune disorders (broad)
Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type: MXPFIZER INC2021092180
Write-up: Stevens-Johnson syndrome; Pain; sensitivity; dizziness; nausea; abdominal pain; tachycardia; This is a spontaneous report from a non-contactable other hcp via e-mail. A 52-year-old male received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot# EJ3002, exp date 01Apr2021), intramuscular at single dose at left arm on 13Jan2021 for covid-19 immunisation. The patient's medical history was not reported. The patient's concomitant medications were not reported. The patient experienced Stevens-Johnson syndrome on 13Jan2021, pain on 13Jan2021, sensitivity on 13Jan2021, dizziness on 13Jan2021, nausea on 13Jan2021, abdominal pain on 13Jan2021, tachycardia on 13Jan2021. Timeframe between vaccination and starting of symptoms: 20 minutes. The events outcome was unknown No follow-up attempts are possible. No further information is expected.; Sender's Comments: Based on a close chronological association causality between event Stevens-Johnson syndrome and BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) cannot be completely excluded. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to Regulatory Authorities, Ethics Committees and Investigators, as appropriate. |
|
| VAERS ID: |
1005841 (history)
|
| Form: |
Version 2.0 |
| Age: |
|
| Sex: |
Female |
| Location: |
Foreign |
| Vaccinated: | 2021-01-20 |
| Onset: | 2021-01-21 |
| Days after vaccination: | 1 |
| Submitted: |
0000-00-00 |
| Entered: |
2021-02-05 |
| Vaccination / Manufacturer |
Lot / Dose |
Site / Route |
| COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH |
EL0739 / UNK |
- / - |
Administered by: Other Purchased by: ?
Symptoms: Stevens-Johnson syndrome
SMQs:, Severe cutaneous adverse reactions (narrow), Oropharyngeal conditions (excl neoplasms, infections and allergies) (narrow), Hypersensitivity (narrow), Drug reaction with eosinophilia and systemic symptoms syndrome (broad), Immune-mediated/autoimmune disorders (broad)
Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? Yes, ? days
Extended hospital stay? No
Previous Vaccinations:
Other Medications: ALENDRONIC ACID; AMITRIPTYLINE; AMLODIPINE; CLENIL MODULITE; RAMIPRIL; SALBUTAMOL; SIMVASTATIN; TRAMADOL
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type:
Write-up: |
|
| VAERS ID: |
1025883 (history)
|
| Form: |
Version 2.0 |
| Age: |
|
| Sex: |
Female |
| Location: |
Foreign |
| Vaccinated: | 2021-01-20 |
| Onset: | 2021-01-21 |
| Days after vaccination: | 1 |
| Submitted: |
0000-00-00 |
| Entered: |
2021-02-12 |
| Vaccination / Manufacturer |
Lot / Dose |
Site / Route |
| COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH |
EL0739 / UNK |
- / - |
Administered by: Other Purchased by: ?
Symptoms: SARS-CoV-2 test,
Tenderness,
Toxic epidermal necrolysis
SMQs:, Severe cutaneous adverse reactions (narrow), Oropharyngeal conditions (excl neoplasms, infections and allergies) (narrow), Hypersensitivity (narrow), Drug reaction with eosinophilia and systemic symptoms syndrome (broad), Immune-mediated/autoimmune disorders (broad), COVID-19 (broad)
Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? Yes
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: ADCAL [CALCIUM CARBONATE]; BUDESONID; CLOPIDOGREL; IVABRADINE; LEVOTHYROXINE; LOSARTAN; PANTOPRAZOLE; PREGABALIN; VENLAFAXIN
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type:
Write-up: |
|
| VAERS ID: |
1034116 (history)
|
| Form: |
Version 2.0 |
| Age: |
58.0 |
| Sex: |
Female |
| Location: |
Virginia |
| Vaccinated: | 2021-01-19 |
| Onset: | 2021-01-30 |
| Days after vaccination: | 11 |
| Submitted: |
0000-00-00 |
| Entered: |
2021-02-16 |
| Vaccination / Manufacturer |
Lot / Dose |
Site / Route |
| COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH |
- / 2 |
UN / IM |
Administered by: Senior Living Purchased by: ?
Symptoms: Biopsy skin abnormal,
Blister,
Dermatitis,
Epidermal necrosis,
Rash,
Skin exfoliation,
Toxic epidermal necrolysis
SMQs:, Severe cutaneous adverse reactions (narrow), Anaphylactic reaction (broad), Malignancy related therapeutic and diagnostic procedures (narrow), Oropharyngeal conditions (excl neoplasms, infections and allergies) (narrow), Skin tumours of unspecified malignancy (broad), Hypersensitivity (narrow), Drug reaction with eosinophilia and systemic symptoms syndrome (broad), Immune-mediated/autoimmune disorders (broad)
Life Threatening? No
Birth Defect? No
Died? Yes
Date died: 2021-02-15
Days after onset: 16
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: Escitalopram 10mg tablet Novolin 70/30 Insulin Diazepam 2mg tablet Simvastatin 20mg tablet Acetaminophen 500mg tablet
Current Illness: Diabetes - Type 2 Dementia CVA s/p L-sided weakness Psychiatric disorder
Preexisting Conditions:
Allergies: Buspirone Morphine
Diagnostic Lab Data: Surgical Pathology reports: FINAL DIAGNOSIS: SKIN, RIGHT THIGH, BIOPSY: SUBEPIDERMAL BULLAE WITH EXTENSIVE EPIDERMAL NECROSIS AND MIXED INFLAMMATORY INFILTRATE. NO EVIDENCE OF MALIGNANCY. Comment: The clinical concern for toxic epidermal necrolysis is noted, and the histologic findings support this impression. Extensive subepidermal bullous formation with associated mixed inflammatory infiltrate composed of neutrophils, eosinophils, and lymphocytes is noted in the larger of the two skin fragments, while the smaller fragment shows diffuse epidermal necrosis, which is compatible with TEN.
CDC Split Type:
Write-up: Presented from clinic with 3-4 days of extensive rash. There were multiple areas of skin sloughing on bilateral upper extremities and abdominal wall. |
|
| VAERS ID: |
1042323 (history)
|
| Form: |
Version 2.0 |
| Age: |
71.0 |
| Sex: |
Female |
| Location: |
Texas |
| Vaccinated: | 2021-02-02 |
| Onset: | 2021-02-03 |
| Days after vaccination: | 1 |
| Submitted: |
0000-00-00 |
| Entered: |
2021-02-19 |
| Vaccination / Manufacturer |
Lot / Dose |
Site / Route |
| COVID19: COVID19 (COVID19 (MODERNA)) / MODERNA |
025L20A / 1 |
- / OT |
Administered by: Unknown Purchased by: ?
Symptoms: Stevens-Johnson syndrome
SMQs:, Severe cutaneous adverse reactions (narrow), Oropharyngeal conditions (excl neoplasms, infections and allergies) (narrow), Hypersensitivity (narrow), Drug reaction with eosinophilia and systemic symptoms syndrome (broad), Immune-mediated/autoimmune disorders (broad)
Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: No adverse event (No medical history reported.)
Allergies:
Diagnostic Lab Data:
CDC Split Type: USMODERNATX, INC.MOD20210
Write-up: Stevens-Johnson Syndrome; A spontaneous report was received from a health care provider regarding a 71-year-old female patient who received Moderna's COVID-19 vaccine (mRNA-1273) and experienced Stevens Johnson Syndrome, which results in blisters and rashes all over the body. The patient's medical history not included. No Concomitant medication was provided. On 02 Feb 2021, prior to the onset of the events, the patient received one of two planned doses of mRNA-1273 (Lot number: 025L20A) for prophylaxis of COVID-19 infection. On 03 Feb 2021, the day after the mRNA-1273 vaccine was given, the patient experienced Stevens Johnson Syndrome, causing rashes and blisters all over her body. Treatment information was not reported. Action taken with mRNA-1273 was not reported. The outcome of the events, Stevens Johnson Syndrome, causing rashes and blisters all over the patient's body, was not reported.; Reporter's Comments: Very limited information regarding this event has been provided at this time. Further information has been requested. |
|
| VAERS ID: |
1045494 (history)
|
| Form: |
Version 2.0 |
| Age: |
|
| Sex: |
Female |
| Location: |
Foreign |
| Vaccinated: | 0000-00-00 |
| Onset: | 2021-01-15 |
| Submitted: |
0000-00-00 |
| Entered: |
2021-02-22 |
| Vaccination / Manufacturer |
Lot / Dose |
Site / Route |
| COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH |
- / 1 |
- / OT |
Administered by: Other Purchased by: ?
Symptoms: Stevens-Johnson syndrome,
Toxic epidermal necrolysis
SMQs:, Severe cutaneous adverse reactions (narrow), Oropharyngeal conditions (excl neoplasms, infections and allergies) (narrow), Hypersensitivity (narrow), Drug reaction with eosinophilia and systemic symptoms syndrome (broad), Immune-mediated/autoimmune disorders (broad)
Life Threatening? Yes
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? Yes, ? days
Extended hospital stay? No
Previous Vaccinations:
Other Medications: MEMANTINE; MIRTAZAPINE
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type:
Write-up: |
|
| VAERS ID: |
1048494 (history)
|
| Form: |
Version 2.0 |
| Age: |
49.0 |
| Sex: |
Female |
| Location: |
Foreign |
| Vaccinated: | 2021-01-21 |
| Onset: | 2021-01-21 |
| Days after vaccination: | 0 |
| Submitted: |
0000-00-00 |
| Entered: |
2021-02-23 |
| Vaccination / Manufacturer |
Lot / Dose |
Site / Route |
| COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH |
- / UNK |
- / - |
Administered by: Other Purchased by: ?
Symptoms: Chills,
Dizziness,
Hypoaesthesia oral,
Nausea,
Pain,
Sensitive skin,
Stevens-Johnson syndrome,
Vomiting
SMQs:, Severe cutaneous adverse reactions (narrow), Acute pancreatitis (broad), Anticholinergic syndrome (broad), Oropharyngeal conditions (excl neoplasms, infections and allergies) (narrow), Guillain-Barre syndrome (broad), Gastrointestinal nonspecific symptoms and therapeutic procedures (narrow), Vestibular disorders (broad), Hypersensitivity (narrow), Drug reaction with eosinophilia and systemic symptoms syndrome (broad), Immune-mediated/autoimmune disorders (broad)
Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type: MXPFIZER INC2021153534
Write-up: chills; pain; sensitive skin; dizziness; nausea; vomit; numbness of the palate and tongue; This is a Spontaneous report from a non-contactable Other Health Care Professional. Regulatory authority report number is 3662. A female patient received bnt162b2 (Lot/batch number and Expiration date were not provided), via an unspecified route of administration on 21Jan2021 at single dose for covid-19 immunization. The patient medical history and concomitant medications were not reported. The patient experienced chills, pain, sensitive skin, dizziness, nausea, vomit, , numbness of the palate and tongue, 10 min after vaccination, on 21Jan2021. Patient was no pregnant. The outcome of the events was unknown. No follow-up attempts are possible. Information about batch number cannot be obtained. |
|
| VAERS ID: |
1051130 (history)
|
| Form: |
Version 2.0 |
| Age: |
70.0 |
| Sex: |
Unknown |
| Location: |
Foreign |
| Vaccinated: | 2021-02-05 |
| Onset: | 2021-02-01 |
| Submitted: |
0000-00-00 |
| Entered: |
2021-02-24 |
| Vaccination / Manufacturer |
Lot / Dose |
Site / Route |
| COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH |
- / 1 |
- / - |
Administered by: Other Purchased by: ?
Symptoms: Exfoliative rash,
Stevens-Johnson syndrome
SMQs:, Severe cutaneous adverse reactions (narrow), Oropharyngeal conditions (excl neoplasms, infections and allergies) (narrow), Hypersensitivity (narrow), Drug reaction with eosinophilia and systemic symptoms syndrome (broad), Immune-mediated/autoimmune disorders (broad)
Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type:
Write-up: |
|
