Age: 59.0
Sex: F
Vaccine: COVID19
Symptoms: Dyspepsia, Erythema, Feeling hot, Pruritus, Tremor
Clinical narrative: severe heart burn; face very hot red over nose and cheeks; face very hot red over nose and cheeks; itchy hives on chest; wheezing and tremors in her legs; wheezing and tremors in her legs; has redness and itching on her cheeks chest; has redness and itching on her cheeks chest; This is a spontaneous report from a contactable nurse (patient) via medical information team. A 59-year-old female patient received first dose of bnt162b2 (COMIRNATY, Solution for injection, Batch number: not reported/ Lot Number: 320308D) via an unspecified route of administration, administered in arm left (reported as left arm) on 27Oct2021 08:30 (also reported as three weeks ago tomorrow) (at the age of 59-year-old) as dose 1, single for covid-19 immunization administered in across from clinic. Patient's relevant medical history included, diagnosed allergies, compromised immune status, respiratory illness, genetic/chromosomal abnormalities, endocrine abnormalities (including diabetes), obesity, allergies to medications and thyroid cancer no thyroid, all from an unknown date and unknown if ongoing. The patient's concomitant medications were not reported. Historical vaccine included patient previously received flu vaccine (unknown manufacturer) on an unspecified date and patient was not allergic to the flu vaccine. Historical vaccine included patient previously received pneumovax vaccine (unknown manufacturer) and hepatitis vaccine (unknown manufacturer) on an unspecified date and experienced allergies. Prior vaccination within 4 weeks was noted as no. Additional vaccines administered on same date of the Pfizer suspect was noted as no. It was reported that the side effects started about 12 hours after the vaccine. On 27Oct2021 21:00, patient woke up with severe heart burn. Her face was very hot and red over her nose and cheeks. She had itchy hives on her chest. She was wheezing. She took Benadryl. She did not take anything prior. It lasted a few hours. She took the Benadryl in response to what was going on. The Benadryl helped. She didn't feel febrile, but she did have some tremors in her legs. Her legs were shaking, but she didn't feel chilled. She had recovered completely. Patient reported she had redness and itching on her cheeks chest that comes and goes on an unspecified date in 2021. It had been a few weeks out now (at the time of the report). She responded to Benadryl. Patient thought that was medically significant, and related. No adverse events required to visit emergency room or physician office. The patient was due for her second shot on 17NOv2021 (reported as tomorrow). She was wondering if she can pre-medicate for the second dose based on what happened 3 weeks ago. She was wondering if there was anything she could do to avoid some of the symptoms. Relevant tests was noted as no. Outcome of the events has redness and itching on her cheeks chest was unknown and outcome of rest of other events was recovered on 27Oct2021.  No follow-up attempts are possible. No further information is expected.; Sender's Comments: Based on limited information in the case , a possible causal association between the reported events heart burn, feeling hot , face red, hives, tremor limb, wheezing, erythema ,itching and the suspect drug BNT162B2 cannot be 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.