Age: 65.0
Sex: F
Vaccine: COVID19
Symptoms: Headache, Injection site pain
Clinical narrative: Soreness in arm injection site; mild headache after first vaccine; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 65 year-old female patient received bnt162b2 (BNT162B2), administered in arm left, administration date 27Mar2021 11:00 (Lot number: ER8732, Expiration Date: 31Jul2021) at the age of 65 years as dose 1, single for covid-19 immunisation. Relevant medical history included: "Hypertension" (unspecified if ongoing), notes: Verbatim: hypertension; "High cholesterol" (unspecified if ongoing), notes: Verbatim: High cholesterol; "Vitamin D deficiency" (unspecified if ongoing), notes: Verbatim: Vitamin D deficiency; "Celiac" (unspecified if ongoing), notes: Verbatim: Celiac; "Asthma" (unspecified if ongoing), notes: Verbatim: Asthma. Concomitant medication(s) included: VITAMIN D [ERGOCALCIFEROL] taken for vitamin d deficiency; VALSARTAN & HCTZ taken for blood pressure measurement; ROSUVASTATIN taken for blood cholesterol. The following information was reported: HEADACHE (non-serious) with onset 27Mar2021 15:00, outcome "unknown", described as "mild headache after first vaccine"; INJECTION SITE PAIN (non-serious), outcome "unknown", described as "Soreness in arm injection site". Therapeutic measures were taken as a result of headache.  Additional information: Dates for mild headache and soreness in arm injection site after first vaccine were from unspecified to unspecified. Reporter seriousness for mild headache and soreness in arm injection site after first vaccine was unspecified. Dates for Pfizer Covid-19 Vaccination was start date as 27Mar2021 and stop date was unspecified. NDC number of Pfizer Covid-19 Vaccination was unknown. Expiry Date of Pfizer Covid-19 Vaccination was 31Jul2021. The patient had other products. The start and stop dates for concomitant products Vitamin D were unspecified. She thinks in February. Eventually, she will be off of prescription and just on OTC and take it daily. The patient was taking concomitant products Vitamin D for Vitamin D deficiency. The start and stop dates for concomitant products QCOQ10 with Lutein were unspecified. The patient had been on for a couple years. Confirms spelling. The patient taking concomitant products QCOQ10 with Lutein (Verbatim) for eye health. The start and stop dates for concomitant products valsartan-HCTZ were unspecified. The patient adds she thinks the HCTZ was hydrochlorothiazide.She had been on quite a while. Less than 10 years but more than 5. She had to go on when her brother passed away, maybe 7 years. The patient taking concomitant products valsartan-HCTZ (Verbatim) for blood pressure. The start and stop dates for concomitant products Rosuvastatin were unspecified. Probably about 4 years but that was a guess. The patient adds that if Pfizer calls her doctor they can give more accurate time frames. The patient taking was concomitant products Rosuvastatin (Verbatim) for cholesterol. Hypertension was diagnosed for about 5 to 7 years. The patient had been diagnosed with about as long as blood pressure. They started her with diet and then every other day medication and now she was on a daily. First she was breaking up pills. Caller adds that was how it goes. Vitamin D deficiency was diagnosed just recently when she was put on Vitamin D 50,000 units. When she went in for her annual, they did blood work and she was deficient. Celiac was Probably diagnosed in 2010. Asthma was diagnosed a long time ago. Investigation assessment was not done. The patient was calling about her Pfizer Covid-19 Vaccination. She stated that she wanted to thank Pfizer for everything they have done in rolling this vaccine in and that there is someone that she can actually talk to when she calls. She had a mild headache and a sore arm for a couple of hours.Reporter stated that the only things she was reporting from the first vaccine were the mild headache and a sore arm. Reporter clarified the other events all occurred after the second vaccine. Reporter states she felt fine with no headache or no anything then. She went about and did her normal activities as she could. Reporter then took Tylenol because of her previous experience to get ahead of arm pain. She was staying hydrated before, during, and after both instances. Reporter stated that she had asthma, and it would not be good. She knows if she got COVID, she would not survive. It was important. It was one of the vaccines everyone needs to get. This has been, this was, a global situation and everyone should all be doing their part. She did this to protect herself, protect everyone else. Even though she had the vaccine, she still masks up, social distances, and follows guidelines and does everything. Nothing changed. This was not giving her a superman cape. And besides, it was still not known how this was going to be against the variances. Vaccination facility details were available. Race information was available. History of all previous immunization with the Pfizer vaccine considered as suspect: no additional. These two times she got the injection was the only time that she got it. She typically did not take Tylenol but that was what was recommended so that was the only time she had taken Tylenol. All vaccines administered on same date with the Pfizer vaccine considered as suspect: none, reporter received last November a vaccine, it was November, a pneumonia vaccine. caller confirms as Nov2020. AE did not required a visit to physician office. But reporter sees her physician every 6 months and is due to see her towards the end of May but hopefully this will be gone by then. The patient had no emergency room visit. The patient had no any other vaccinations within four weeks prior to the first administration date of the suspect vaccine. The patient had no AEs following prior vaccinations reporter was fine after the pneumonia one and when her granddaughter was born, she had another one, but can not remember. That was almost 7 years ago. Tetanus, she had been fine. Anything she had received to date had not been an issue. No relevant tests were performed. Reporter added that she sees her primary doctor every 6 months because of Hypertension and all other doctors she sees once a year. Reporter added that she just remembered something she forgot about it and this might have to do with her hands. Reporter added how could she forget about this. About three years ago, she went to have her hands evaluated because she was on the computer and mousing all the time. Her fingers were starting to lock up, like a trigger finger. Caller got cortisone shots. What happened was for this particular situation, they tested her and put her through tests for carpal tunnel. That was fine, it was just the tendon. Reporter added that cortisone was 97% effective and cure without surgery. People can receive a maximum of 2 injections. She does not remember which fingers and which hand. She did shortcuts where one hand was on shortcuts and the other hand was on her mouse, and it was wear and tear on her hands.Last summer, she went because her right index finger was locking up again and so she received a second cortisone shot. If it does not last, then she will have to do surgery. She had this on both hands. It was not every finger, she thinks it was her right hand ring and index finger and the same for the left. Reporter added the name of the facility where she had this done was Sports Medicine and Pfizer has permission to contact them if they want to. Reporter added that the doctor. Reporter forgot that she had these cortisone shots and adds that you never know if the vaccine interacted with the cortisone. Reporter did not know LOT NDC or expiration or additional information of the cortisone she received but stated that Pfizer can call the doctor if they want to. Reporter asks what happens if this continues and was going to be an ongoing situation. They were not going to know what to do if she calls her primary doctor, because this was new to everybody. Reporter was in a quandary. She was not going to know what to do. He would not know what to do. Nobody would know how to treat it because we know this was new. She hopes it goes away. Reporter added that she feels fine, it was just in her hands. It was like she knows it was allergy season so she was going back and forth with headaches. Reporter added that there was also her stomach - but she thinks it was a stomach bug. Communication: Reporter clarified that the allergies and stomach bug occurred before both vaccines. She added that this happened before. Reporter stated that her mind gets to thinking what else was the vaccine doing in her body. Communication: Reporter interrupted call handler several times and would not clarify all dates. Clarifying details added as caller provided. Dates not entered into formal field as caller stated re-occurrences. Reporter asked what happens now and if Pfizer will contact her. Reporter was given report reference number, callback number and options and hours. Reporter advised to speak with her physician for medical advise.  No follow-up attempts are needed. No further information is expected.