Age: 88.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Cough, Vaccination site pain
Clinical narrative: he is coughing now; soreness in muscle on site on injection; This is a spontaneous report from a contactable consumer. An 88-year-old male patient (husband) received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; Batch/lot number: EL9261, expiry date: May2021), intramuscular on 23Jan2021 11:30 AM at 0.3 mL, single on left deltoid (reported as "0.3ml by IM (intramuscular) injection once to in left shoulder, the usual place") for COVID-19 immunisation (reported as "88 and they are not anxious for him to get COVID/he has deep lung disease and if he didn't get it, he may die from it").  Vaccination facility type was a special clinic set up by hospital. Vaccine was not administered at facility. Medical history included deep lung disease, total reverse shoulder surgery in Jul2020, asthmatic, lung problems. Patient has no compromised immune system. Patient's only allergic reaction was old tetanus (tetanus toxoid) but he was really fine. Patient had tetanus toxoid in 1950, he was a very young man and he has not had it since then, the reporter does not believe they give it anymore. No family medical history relevant to adverse events, also reported as "No, but there is no history for the COVID vaccine, we are only 3 months into it". Concomitant medication included omalizumab (XOLAIR) for lung problems and asthmatic. No additional vaccines administered on same date of Pfizer product. After the first 3 days, patient got the vaccine on 23Jan2021. Patient is now on day 9 but the first 3 days after, he had no side effects. On the 4th day (27Jan2021), he developed soreness in his muscle on the site of injection, and the next day it was increasingly sore, on the 28Jan2021, 29Jan2021, 30Jan2021, and was quite incapacitated, he could not use it, it was really bad, now he was beginning to improve. The reporter wanted to Pfizer to know the length and depth. It only had to do with the use of the muscle not, he was not suffering when not using the arm, a couple days were really bad, he did feel it when he was not using it, but most of the time, the pain came when he needed to use it. The reporter talked to enough who said don't worry, but patient had a total reverse shoulder surgery in Jul2020, in that arm and asked "could that injection exacerbate anything going on there?  Most doctors said to not worry about it". The reporter wants to help COVID. The reporter got hers minute after his husband and she had no side effects whatsoever, so if there was any question about something going on at the site, she could not imagine hers would be so perfect. The event did not require emergency room and physician office visit, further reported that patient had multiple health issues. Patient was coughing now(01Feb2021), over the years, reporter has learned to deal with many things without going to Urgent Care, ER, patient was 88 and the reporter wanted to keep his husband out due to COVID. The reporter called friends who were medical doctors (MDs), as the reporter was worried, the patient was coming out of it. Patient has one injection, a new medication he was on a biologic. Patient was first refused to get the COVID vaccine due to biologic, and the day before he had received it, so they discussed and decided because of biologic, "XOLAIR". There were no adverse events prior vaccinations. Patient went on Friday for his next Xolair, he had no problems then. There were no relevant tests and was reported that patient has been there the whole time, at home, has been under quarantine since last Mar2020. If anything threw up a red flag, reporter would think it would be something they would explore, maybe for the Xolair, when this question came up, it was several days before the vaccine, patient was refused. Patient was asked if there were other injections, reporter said that his husband would have "one the one day before", and they canceled his appointment, and he went to the doctor, the pulmonologist, who administered Xolair, and reporter said that his husband was refused, the doctor said no, "it's a biologic, he was giving it to patients having the COVID vaccine, there were no interactions, and reinstated approval and everything was a go". Outcome of the event "soreness in muscle on site on injection" was recovering while for coughing was unknown.