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|History of Changes from the VAERS Wayback Machine|
|Vaccination / Manufacturer||Lot / Dose||Site / Route|
|COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH||- / 4||- / OT|
Administered by: Other Purchased by: ??
Symptoms: Erythema, Pain, Pain in extremity, Pruritus, Pyrexia, Rash, Off label use, Extra dose administered
Life Threatening? No
Birth Defect? No
Permanent Disability? No
Office Visit (V2.0)? No
ER or Office Visit (V1.0)? No
ER or ED Visit (V2.0)? No
Preexisting Conditions: Medical History/Concurrent Conditions: Atopic dermatitis (patient''s mother); COVID-19; Dermatitis
Diagnostic Lab Data:
CDC 'Split Type': TRPFIZER INC202101214782
Write-up: The redness spread to the scalp over time, accompanied by itching.; Arm pain; Fever; Body pain; Rash; itching after 4th dose; Off-label use; Extra dose administered; This is a spontaneous report from a contactable pharmacist (patient herself). This is the second case of two linked cases. This case is for 2nd dose of BNT162B2 vaccine. A female patient of an unspecified age received fourth dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection with Batch/Lot number was not reported) via intramuscularly, in Arm on 13Sep2021 as single dose for COVID-19 immunisation. Medical history included COVID-19 from 11Nov2020 to an unknown date and dermatitis. The patient''s concomitant medications were not reported. The historical vaccines include third dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection with Batch/Lot number was not reported) via intramuscularly, administered in Arm on 13Jul2021, single dose for COVID-19 immunization and experienced with Arm pain. Family history included the patient''s mother has atopic dermatitis. The patient experienced itching after 4th dose and the redness spread to the scalp over time, accompanied by itching on 13Sep2021. On 14Sep2021 the patient developed erythema, arm pain, fever, body pain and body rash. Clinical course included patient stated that Itching started under the breast 2 hours after vaccination. She used Loratidine on the evening of 13Sep2021 and the itching stopped. The itching became more severe on the morning of 14 September and started again, although Loratidine was used in the evening of 14Sep2021, it did not subside, and the patient stated that he had a very difficult night on 14 September. The redness spread to the scalp over time, accompanied by itching. The consumer also stated that she had experienced fever, arm pain and body pains and did not consider them serious. When the consumer woke up on the morning of 15Sep2021, she stated that all events had recovered, but she was afraid of the recurrence of itching and redness. She has not visited the doctor yet, but there is a request for medical information about the treatments she has applied and can apply. She stated that she will enter the emergency room in case of recurrence. Seriousness of event (itching) was reported as serious (medically significant). The patient received treatment with Parol (paracetamol) for arm pain and fever. And she stated that she had taken Claritin tablets with the active ingredient Loratidine. The outcome of events (off label use, extra dose administered and Rash) was reported as unknown and other events were recovered on 15Sep2021. Batch/lot number was requested.; Sender''s Comments: Based on available information, a possible contributory role of BNT162B2 vaccine cannot be excluded for the reported events due to temporal relationship. 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
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