Age: 17.0
Sex: M
Vaccine: COVID19, MNQ
Symptoms: Diarrhoea, Flushing, Hypersensitivity, Malaise, Off label use
Clinical narrative: did not feel good; Welts from head to toe/was itchy like a rash/red with welts all over; Diarrhea; allergic reaction; itchy like rash/itching all over; fever; flushed; got another vaccine on the same date as the COVID-19 injection, MENACTRA; got another vaccine on the same date as the COVID-19 injection, MENACTRA; This is a spontaneous report from a contactable nurse (patient's mother). A 17-year-old male patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE Solution for injection), via an unspecified route of administration, administered in the arm (reported as deltoid/arm), in the afternoon of 30Jul2021 (Batch/lot number: ER8737), at age 17 years old, as dose 1, single, for COVID-19 immunisation; and meningococcal vaccine a/c/y/w conj (dip tox) (MENACTRA), via an unspecified route of administration, administered in the arm (reported as deltoid/arm), on 30Jul2021 (reported as same date as BNT162B2) (Batch/lot number unknown), as second dose, for meningitis immunisation. Relevant medical history was reported as none. There were no concomitant medications. Historical vaccine included meningococcal vaccine a/c/y/w conj (dip tox) (MENACTRA) received on an unspecified date, as the first dose, for meningitis immunsiation and the patient did not have any problems after this. The patient had no prior vaccinations within 4 weeks. On 30Jul2021, the patient received BNT162B2. The patient got another vaccine on the same date as the COVID-19 injection, MENACTRA. On 04Aug2021, the started complaining of welts. It was from head to toe. It was itchy like a rash. At first, the reporter thought it was bug bites. He had it all over, it was even behind his ears. It was flushed. Maybe it was from the scratching he'd been doing. He was red with welts all over. The reporter thought the patient had fever, but the patient did not think he had fever and was saying he did not have fever. The patient would not allow the reporter to take his temperature. The patient also had diarrhea. On 05Aug2021, the patient did not feel good and added he was having diarrhea and itching all over. The diarrhea was pretty bad and was worse than the day before. It was reported that welts and diarrhea worsened. The patient's breathing was fine. The reporter sounded like she stated that "maybe they gave too much" (as reported). The reporter stated that with allergic reaction, she did not think much can be done unless it affects breathing. She then stated, "is there anything that can be done?" The reporter gave the patient some BENADRYL 50 mg. The reporter wanted to know if the patient should get the second shot and if it will be safe. The events did not result to emergency room and physician office visits. The outcome of urticarial rash and diarrhea was not recovered. The outcome of the remaining events was unknown. The reporter assessed the events urticarial rash and diarrhea as serious (medically significant).; Sender's Comments: Based on available information, a possible contributory role of BNT162B2 vaccine cannot be excluded for the reported events of "Urticarial rash" "Diarrhoea" due to temporal relationship and current known drug safety profile. 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