Age: 69.0
Sex: F
Vaccine: COVID19
Symptoms: Pyrexia, Vomiting
Clinical narrative: flu-like symptoms; fever; chills; aches/pains; vomiting; abdominal pain -feels like severe case of the flu; This is a spontaneous report from a contactable nurse reported for self. This 69-year-old female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Batch/Lot number: EL9267) at single dose on 09Feb2021 14:15 in left arm for COVID-19 immunisation. Medical history included severe respiratory infection from Nov2019. Patient thought she might have had COVID, but she was way early, before anyone knew it was in the country, back in Nov2019, she had a severe respiratory infection. Patient stated that her husband was a respiratory therapist, and he fortunately had enough albuterol to choke a horse with, and if it had not been for that and the nebulizer, the caller would have had to go to the hospital. Patient stated that she would wake up in the night and need three or four treatments. Patient stated that before being sick, she had horses and it would take 15-20 minutes to do her routine with the horses, but while she was sick, it took two hours. Patient stated that she would walk out and back, and it was an ordeal, she was tired and short of breath. Patient stated that the doctors called it severe respiratory inflammation, and that was in Nov and Dec2020. Patient stated that she was put on steroids at that time, and she really didn't want to go back to the doctor, so she took some of her husband's steroids, he had some dexamethasone, and she took that and started to feel better. There was no concomitant medication taken. Patient reported flu-like symptoms on 11Feb2021 after her first dose of Pfizer Covid19 vaccine. Symptoms included fever, chills, aches, pains, vomiting, abdominal pain -felt like severe case of the flu on 11Feb2021. Patient would like to know if these were normal adverse events and if they could be worse for her, because she may have had a Covid infection previously. Patient asked what was the efficacy after one dose of the Pfizer-Biontech Covid19 vaccine if she chose not to get the second dose. Patient took her first dose of the Pfizer COVID vaccine on 09Feb2021. Patient stated that two days later, she had side effects and had had them for the last 6 days. Patient stated that if someone picked it, she had it. Patient stated that she had a fever, chills and pain. Patient's fever was running at 102.5 in Feb2021, and she could get it down with paracetamol (TYLENOL) and alcohol. Patient stated that she heard somewhere that the first dose offers 85% protection against the virus, and she was wondering if that was accurate. Caller was scheduled for her next dose on 09Mar2021. Patient was still having aches and pains, and she had vomiting. Patient stated that she was still not over this part of it yet. Patient stated that her side effects started on 11Feb2021 between 4 and 5PM, so more than 48 hours later and they all of a sudden just hit her. Patient stated that the vomiting had stopped, but she did still get some abdominal pain once in a while, but the vomiting stopped about two days ago, but for a while she could not keep food down, and she was just trying to take paracetamol (TYLENOL). For events fever, chills, aches and pain, patient confirmed that these were all still ongoing, but they were getting better. Patient stated that these side effects were a little better yesterday, the caller got up and took a dexamethasone 5 mg and felt better. Patient stated that when she woke up this morning, she was feeling god awful, so she took another dexamethasone, and she was better this afternoon. Patient planned to go to an urgent care today, but she had not been to a doctor yet. Patient stated that they must not have been that serious because she did not go to a doctor, it was like a bad case of the flu, feeling like she got run over with a truck. Patient stated they were serious, but nothing life threatening, caller confirmed all side effects were medically significant. Patient stated that she read that people who had COVID, would react with more severe side effects to the vaccine than people who did not have COVID, and she was wondering if that was correct. The outcome of event vomiting was resolved in Feb2021, outcome of event abdominal pain was unknown. The outcome of rest events was resolving.  The patient assessed drug result was related for all the events, Method of assessment: Global Introspection.; Sender's Comments: The Company cannot completely exclude the possible causality between the reported "flu-like symptoms and associated fever, chills, aches, pains, vomiting, abdominal pain " and the administration of COVID 19 vaccine, BNT162B2, based on the reasonable temporal association and lacking alternative explanations. More information such as complete medical history and concomitant medications are needed for fully medical assessment.   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.