Age: 64.0
Sex: F
Vaccine: COVID19
Symptoms: Diarrhoea, Erythema, Gastrointestinal disorder, Pruritus, Rash
Clinical narrative: head and ears were itchy; but she has gastrointestinal issues; A little bit of erythema; diarrhea; On her neck she had hives up to her face and down her chest a little bit/urticaria eye lid; rash on neck up to her face; rash on shoulder that she had injection in; This is a spontaneous report from a contactable other hcp (nurse). A 64-year-old female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Formulation: Solution for injection, Lot Number: EN6206), via intramuscular route of administration, in the right arm on 05Mar2021 09:30 (at the age of 64-years-old) as single dose for covid-19 immunisation. Medical history included ongoing rheumatoid arthritis, anaemia, cardiac disorder, rash (She has had a reaction to IVP dye. She has to pre-medicate with benadryl and a steroid 10 hours before, then 8 hours before, then 1 hour before procedure prior to receiving IVP dye. When querying NDC/Lot/Expiry for IVP dye, caller states she does not have that information, it happened years ago. She always pre-medicates when she has to have have x-rays with the dye). The patient did not have history of all previous immunization with the BNT162B2 vaccine considered as suspect (or patient age at first and subsequent immunizations if dates of birth or immunizations are not available). Concomitant medications included tofacitinib citrate (XELJANZ XR) via oral route of administration from an unspecified date (been on for 2 years) and ongoing at a dose of 11 mg daily for rheumatoid arthritis; ergocalciferol (VITAMIN D [ERGOCALCIFEROL]) for an unspecified indication; tramadol (TRAMADOL) via unspecified route of administration from an unspecified date and ongoing at a dose of 50 mg daily (in morning) for rheumatoid arthritis; gabapentin (NEURONTIN) via unspecified route of administration from an unspecified date and ongoing at a dose of 300 mg twice daily for rheumatoid arthritis and Multivitamin for an unspecified indication. The patient previously took buprenex and experienced drug hypersensitivity, buprenex and experienced nausea and vomiting, avelox and experienced angioedema. The patient did not underwent any Lab tests.The patient did not receive any recent vaccines for any other conditions prior to the event being reported. The patient did not receive any recent vaccines for SARS-CoV2 other than BNT162B2 Vaccine prior to the event being reported.The patient did not received any other vaccines around the time of BNT162B2 vaccination. She was calling about the Covid vaccine. She had her first dose this past Friday, clarified 05Mar2021. It's been a week. On the evening about 8 hours after the Covid 19 injection she got a rash on her shoulder that she had the shot in. The rash went across her chest to the other shoulder. On her neck she had hives up to her face and down her chest a little bit. She has been taking Benadryl for the past 6 days. She is very concerned what is going to happen with the next dose. She contacted her primary health care provider and it was recommended that the caller pre-medicate. The caller states it says not to pre-medicate. She has her next Covid 19 vaccine in 2 weeks and she was nervous. She did file a report with the government. It was in the information she received from the hospital where she got her Covid 19 injection. Every day at 2:00PM she gets a text message. They monitor her for up to a year. Every day she checks in and says how she feels, is she having trouble completing daily activities, did you have to call your doctor. They gave her a paper at the hospital where she had it done. When querying if this government program had given her a report number she states she doesn't have a report number, she deletes the text messages every day. She is due for the second Covid vaccine on 26Mar2021. It was reported that several hours after the injection in the evening, maybe 8 hours after she had the injection is when her symptoms began. She does feel like she is improving. Today was the first morning that she didn't take the Benadryl. She had no respiratory problems. But she was very concerned because the hives were pretty prevalent. It was very uncomfortable. She was taking 50mg of Benadryl for 5 days. When she went to the pharmacy to pick up a cream too, the pharmacist thought that a steroid would be good. She was concerned. She emailed her primary care doctor with pictures. When querying seriousness of events, caller states it was bad enough that she went to the pharmacy and called her primary care doctor and sent her pictures. If she had developed any respiratory issues she would have gone to the emergency room. If she was non medical she would have gone to the emergency room but because she's a nurse she thought she would ride it out. When querying information for the Pfizer Covid 19 Vaccine data capture aid, the caller reports the hives were 48 hours later. She also reports urticaria, her head and ears were itchy. She is using steroid cream on it. It is driving her crazy today. Still going to be using the cream. A little bit of erythema, worst part was her neck. When querying red and itchy eyes, she reports only the eyelid. When querying gastrointestinal issues, she reports she has diarrhea, but she has gastrointestinal issues. The diarrhea is nothing worse than what she normally has. She doesn't think this has anything to do with the vaccine. The patient did not visited to emergency room and physician office. The patient was not hospitalized or admitted to an intensive care unit. Therapeutic measure were taken with Benadryl 25-50mg (Lot Number:P134952, Expiration date: Sep2021) and Hydrocortisone cream 1% maximum strength for the events. It was reported that Benadryl makes her hyper and her heart racey.The outcome of the event diarrhea, gastrointestinal issues were repoorted as unknown, event head and ears were itchy was not recovered and recovering for other events. The events rash on shoulder that she had injection in, hives on neck, rash on neck up to her face were assessed as serious (medically Significant) by the reporter. The causality of the events rash on shoulder that she had injection, hives on neck, rash on neck up to her face were reported as related to vaccine.; Sender's Comments: Based on the current available information and the plausible drug-event temporal association, a possible contributory role of the suspect product BNT162B2 to the development of serious events cannot be excluded.  The case will be reassessed if additional information becomes available.  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.