Age: 62.0
Sex: F
Vaccine: COVID19
Symptoms: Dyspnoea, Fatigue, Headache, Muscular weakness, Nausea
Clinical narrative: soreness in the arm where the injection was given; nauseous in her stomach; headache; weakness in her arms and legs; tingling in her arms and legs; fatigue; rash; Itching; Hives; Difficulty breathing; This is a spontaneous report from a contactable consumer (patient). A 62-years-old female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, Batch/Lot Number: EW0172), via an unspecified route of administration, administered in Arm Right on 15May2021 09:30 as SINGLE DOSE for COVID-19 immunisation. Patient medical history included ongoing severe allergies, ongoing fibromyalgia, sciatica, and carpal tunnel. No family medical history relevant to AE. It was described about unspecified other condition; patient was diagnosed many years ago when she was young that it had to be over 20 years ago. Concomitant medications included cetirizine hydrochloride (ZYRTEC ALLERGY) taken for allergy, start and stop date were not reported. Patient was treated with allergy pill, which was the generic Zyrtec, a 10mg tablet and maximum strength cortisone ointment, hydrocortisone, 1%. Patient reported that on the very first day (15May2021) she experienced soreness in the arm where the injection was given, the soreness resolved in about 2 or 3 days, stated that her arm started getting less sore on day 3. Clarified it recovered completely. Later that day she felt nauseous in her stomach, that lasted about one day, it was only on the day of the shot. She has had a headache ever since she received the vaccine, but she did not know if it is from her allergies or not. She said that it was hard to determine the onset, but she had been having a headache every day. She did not remember when it started exactly because of her allergies, but she knows for the last couple of weeks that she has had a headache almost every day and it was hard to determine because of all the pollen. She was also been having a lot of weakness in her arms and legs, which had been going on for the last two weeks. She was also been experiencing fatigue and tingling in her arms and legs, but she cannot remember when this all started. She continued to describe the events that she experienced after receiving the first dose of the vaccine as having a rash, itching, and hives happened twice to her now. Clarified that it happened once last week, although she did not remember the day and that it happened to her today for the second time. She woke up at 05:30 AM, she said that this event wakes her up for some reason and they come out. She gets really bad itching and that she took pictures because it was really bad. She confirmed that this happened in late May 2021 and again today. When asked about the outcome of the rash, itching, and hives, she stated that, it happens once a week, so it was strange, and it was difficult to breathe with it too. She clarified that the difficulty breathing started with the rash, itching, and hives last week. She stated that all of these gone away eventually. She stated that once she gets up and gets like that she immediately jumps in the shower, takes an allergy pill, and puts cortisone all over it. She said that two hours later her symptoms start to fade away so she cannot get to the doctors office, but she took a picture of her leg and sent it to her doctor on the portal, was waiting to hear back. She stated that she was due to get her second COVID shot on Saturday and wanted to know if she should get it and also asked if she should file another report with her side effects with the other reporting agency listed on her vaccination card. No history of previous immunization with the Pfizer vaccine considered as suspect. No Additional Vaccines Administered on Same Date of the Pfizer Suspect. Patient did not receive any other vaccinations within four weeks prior to the first administration date of the suspect vaccine. The patient experienced events soreness in the arm where the injection was given and nausea on 15May2021; remaining events experienced on an unknown date in May2021. The patient was not visited to Emergency Room and Physician Office for the events. The outcome of the events soreness in the arm where the injection was given was recovered on an unknown date in May 2021; nauseous in her stomach was recovered on 15May2021; outcome of Headache, weakness in her arms and legs, tingling in her arms and legs and fatigue was not recovered; outcome of the events rash, Itching, hives and difficulty breathing was unknown.  No follow-up attempts are needed. No further information is expected.