Age: 51.0
Sex: M
Vaccine: COVID19
Symptoms: Insomnia, Myalgia, Nasal congestion, Pain, Pain in extremity
Clinical narrative: Headache; major backpains like all my muscles still hurt at my back; my muscles at my back are still killing me; can not sleep; sore arm; muscle ache; congestion; Caller states they still have aches and pains/major body aches like we have gotten beat up; achy and sore; fever; shivers/chills; soaked in sweat; This is a spontaneous report from a contactable consumer (patient) reporting the same events under the same suspect product for 2 patients. This is the one of two reports.   A 51-year-old male patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Batch/Lot Number: FE3592), via an unspecified route of administration, administered in arm right on 06Sep2021 (at the age of 51-years-old) as dose 1, single for COVID-19 immunisation.  Medical history included COVID-19 (Caller states him and his wife were diagnosed with Covid and were quarantined for 10 days) from 28Aug2021 to 28Aug2021 and bad dreams from an unknown date. The patient's concomitant medications were not reported. The patient experienced congestion (nasal congestion), headache, major backpains like all his muscles still hurt at his back; his muscles at his back are still killing him, cannot sleep, sore arm and muscle ache on an unspecified date; aches and pains/major body aches like they have gotten beat up; achy and sore, fever, shivers/chills and soaked in sweat on 07Sep2021 at 01:30. The clinical course was as follows: Him and his wife were diagnosed with Covid and were quarantined for 10 days, which they did. On the 10th day, they called the nurse and the pharmacy and they both agreed they could receive the vaccine. He was feeling good the day he received the vaccine but the next morning after receiving the vaccine him and his wife had fever, chills, and shivers that lasted about a day and a half. They felt good on the day they received it but then woke up at 10:30 the next day with the whole 9 yards. Caller states they still have aches and pains. Caller states that when they went to the hospital the doctor asked why they received the vaccine, that they were supposed to wait 90 days after having Covid, but they are supposed to come back in 3 weeks for their second dose, and asks do they wait 90 days for the second dose? Adverse events: Consumer stated "I started feeling the side effect when they gave me the injection on labor day, I was great that day, my wife was there with me, we both got it, we were both quarantine, then 6 of this was our last day of quarantine so we called the hospital back and said when can we receive our vaccine, well the lady we called says you are good you can come get it now, we got to the pharmacy the pharmacy checked our paper work, they said you are good, you can get it today if you say you are done, the doctor then gave it to us and said yeah you are good, so we went ahead and got it, that night about 1:30 in the morning we both woke up soaked in sweat, shivering, the chills, fever, major body aches like we have gotten beat up real achy and sore and we were feeling like that the day on Monday that we got it till that night so it happens pretty quick." Other medical conditions: Consumer stated, "No, sir that is the only thing I have right now is chills, the headache, the major backpains like all my muscles still hurt at my back, the sore arm which lasted like 3 days but all my muscles at my back are still killing me and my headache is not going away, they go away for a while and they come back." Other medications: Consumer stated "No, just the (incomplete sentence), I stopped taking the Ibuprofen (hence captured as suspect product) they prescribed me because it was giving me bad dreams, so I stopped taking that, I am just taking Tylenol (treatment) and a decongestive syrup (further clarification unknown) for the congestion." When probed if still experiencing all adverse events: Consumer stated, "Yes." Outcome of event: Consumer stated, "Pretty much persisting, they are same, they have just been steady, I get up in the morning, work back, I try to sleep, I cannot sleep long cause my back hurting my muscles and my back are hurting really bad, then the headache sometimes, it just hurts my head on the pillow, so it is a really bad headache." Treatment (other than Tylenol) for adverse events: Consumer stated, "No, nothing else just that, the syrup for the congestion and the Tylenol that is it." Date of second dose of vaccine: Consumer stated, "Well they said in three weeks, which would be on 27th, I have not received it yet but my concern is because when we got it on the 6th my wife went back to the doctor she was experiencing the same exact thing I am experiencing, so she went on Tuesday and they said no you are supposed to wait 90 days until you are better, all this nursling telephone, the health center and the doctor told us we were good, so we did it and when we found out we were supposed to wait 90 days so we are curious we can get the second dose on the 27th or we wait and our doctor told us to contact you all directly to contact you cause even she did not have an answer". The patient underwent lab tests and procedures which included body temperature: unknown results on 07Sep2021. Therapeutic measures were taken as a result of congestion, headache and muscle ache. The outcome of the events was unknown.  No follow-up attempts are completed. No further information is expected.; Sender's Comments: Linked Report(s) : US-PFIZER INC-202101214581 Same reporter, drug, event and different patient