Age: 65.0
Sex: M
Vaccine: COVID19
Symptoms: Asthenia, Fatigue, Feeling abnormal, Head discomfort, Headache
Clinical narrative: bad headache/got a fiery pounding headache that felt like his head was going to explode; felt very fatigue/fatigued; feeling funny, crappy; feeling really bad with body aches; a little weak; bad headache/got a fiery pounding headache that felt like his head was going to explode; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP) from medical information team. The reporter is the patient.  A 65 year-old male patient received bnt162b2 (BNT162B2), administered in arm left, administration date 03Mar2021 17:30 (Lot number: EN6199) at the age of 65 years as dose 1, single for covid-19 immunisation. Relevant medical history included: "Orthopedic surgeries", stop date: Dec2018, notes: Verbatim: Orthopedic surgeries; "Arthritis" (ongoing), notes: Verbatim: Arthritis; "Chronic pain" (unspecified if ongoing), notes: Verbatim: Chronic pain. Concomitant medication(s) included: LEVETIRACETAM; OXYCODONE taken for pain; LISINOPRIL taken for blood pressure measurement; FENTANYL taken for pain; DEPO TESTOSTERONE; EXCEDRIN EXTRA STRENGTH; ARMODAFINIL taken for sleep apnoea syndrome. The following information was reported: HEADACHE (non-serious) with onset 04Mar2021, outcome "recovered" (05Mar2021), HEAD DISCOMFORT (non-serious), outcome "unknown" and all described as "bad headache/got a fiery pounding headache that felt like his head was going to explode"; FATIGUE (non-serious), outcome "unknown", described as "felt very fatigue/fatigued"; FEELING ABNORMAL (non-serious), outcome "unknown", described as "feeling funny, crappy"; PAIN (non-serious), outcome "unknown", described as "feeling really bad with body aches"; ASTHENIA (non-serious), outcome "unknown", described as "a little weak". Therapeutic measures were taken as a result of headache.  Additional information: Patient received his first Pfizer Covid vaccine on 03March2021. The following day he experienced a bad headache that lasted about eight hours. He took Excedrin with no relief. On the third day he felt very fatigue. He asked the chances of the second vaccine being worst. He asked if his medications will interfere with the Pfizer Covid vaccine, Keppra, Fentanyl Patch, Lisinopril, Gabapentin, Armodafinil, Oxycodone5/325. The patient AE(s) did not require a visit to Emergency Room/physician office visit. The patient was not hospitalized. Additional Information for Concomitant Products Excedrin Extra Strength: Start around 20 years of age.Bottle with him that he thinks consumed dose from 03Mar2021:Lot:610197,Expiry:Apr2022,UPC:Unknown,box discarded. Distributed by Consumer Health. Armodafinil: If he is real tired, had a bad night he will take a full tablet, otherwise just takes 1/2 tablet. Additional Information for Other Conditions: 40 years old:1st rotator cuff shoulder surgery.45 years old:1st hip replacement.10 surgeries over next 20 years, every 2 years: another hip replacement,5 other torn rotator cuff surgeries-last in Dec2018-dislocated shoulder which is what tore rotator cuff and was worst of all of them;2 knee surgeries; and added there was a bone fusion of left wrist where they put a steel plate in also. Additional Information for Other Conditions: Reported having arthritis teeming through his veins. He has been a painting contractor since 17 years of age; mother had the same problems with her shoulders, knees and hips and so did his sister so his Arthritis is genetic as well as contributable to his occupation. Additional Information for Other Conditions: Had chronic pain for probably 20 years and been on pain medication for probably 13-14 years so he knows what pain and suffering is. He is a tough individual. This consumer reported being administered his first dose of Pfizer-BioNTech COVID-19 Vaccine 03Mar2021 around 17:30 at the store. He reported having pretty bad side effects from the first dose of the Pfizer-BioNTech COVID-19 Vaccine. He asked for information on if it is safe for him to get the second dose of the Pfizer-BioNTech COVID-19 Vaccine; what to expect with the second dose of the Pfizer-BioNTech COVID-19 Vaccine because they say the second dose is worse than the first which has him concerned. His second dose of Pfizer-BioNTech COVID-19 Vaccine is scheduled 24Mar2021. He also asked for concomitant product interaction information with the Pfizer-BioNTech COVID-19 Vaccine because no one asked him what medications he takes. He does not think anyone will be able to tell him about what to expect with side effects because everyone is different. He is in a position where if the second dose of the Pfizer-BioNTech COVID-19 Vaccine is worse he is going to be in trouble, he will be in the emergency room, he knows his body. Pretty bad side effects: Onset date/time 04Mar2021 around 11:00 he started feeling funny, crappy while he was out at a doctors appointment. He got home around 12:00 and around 12:00-13:00 he had headache just come on him and started feeling really bad with body aches. He sat on the couch and by around 13:00 he put his dog in the kennel, which he never does, and went to lay in bed. He never gets headaches, but on 04Mar2021 he got a fiery pounding headache that felt like his head was going to explode. He thought about calling his son to take him to the hospital but then thought what is that gonna do, they're just gonna say it is a side effect so he did not go to the hospital. Headache and body aches lasted about 8 hours. This event is probably in the top 10 sick as he has been. It was brutal and just went on and on. He tried taking Excedrin Extra Strength for the headache and putting ice packs on his forehead and neck- he initially reported he tried taking Aspirin, but clarified that what he took was not Aspirin, it was Excedrin Extra Strength. Outcome: He felt he recovered completely, pretty much back to normal but it is hard to distinguish because he feels crappy every day; but this event was way out of line, outer space stuff. He never gets a headache; the last time he got a headache was in his 20s or 30s and he only got hangover headache. The headache started fading by around 19:00-20:00 04Mar2021, he knew it was going away. He fell asleep at 22:00 and woke the next morning on 05Mar2021 and did not have the headache, but was fatigued, felt crappy and a little weak for probably 2-3 more days but nothing further out of the normal for him.Excedrin Extra Strength he has taken 2-4 tablets daily probably since he was around 20 years of age because he has been involved in sports his whole life and the Excedrin Extra Strength does help with the pain; but when he took the Excedrin Extra Strength for the headache on 04Mar2021 the Excedrin Extra Strength did not touch the headache, but the ice packs on his forehead helped a ton, he knows that from all the injuries he has had historically. He reported that his arm was not sore after the Pfizer-BioNTech COVID-19 Vaccine administered. He still plans to get the second dose as scheduled for 24Mar2021, even if it almost kills him he would probably still get it. He reported other concomitant product that is not relevant to this report is Gabapentin taken infrequently, just as needed for neuropathy in his feet-he does not get the neuropathy in his feet often, it is sporadic, so he has not taken Gabapentin in probably 3 months. Regarding information caller mentioned about they say the second dose is worse than the first: Everyone says the second shot of Pfizer-BioNTech COVID-19 Vaccine is worse than the first. He can't imagine it being worse. What he knows about these patients and events is that it was not their first shot of Pfizer-BioNTech COVID-19 Vaccine, which they probably had mild side effects from, but the main thing he heard about second dose being worse is their arm being sore which he reported as ridiculous, that's not a side effect, that's just whining, why would anyone even mention having a sore arm. He reported that if 100 people had this headache that he had we would have 100 people calling to report it. he declined to provide any further information regarding those other patients or reports, Pfizer-BioNTech COVID-19 Vaccine: Lots/NDCs/Expiries: Not provided, caller was unwilling to complete reports.  Description of Product Complaint: Consumer reported adverse events with Pfizer-BioNTech COVID-19 Vaccine. During report mentioned he took Excedrin Extra Strength for headache on 04Mar2021. The Excedrin Extra Strength did not touch the headache, but the ice packs on his forehead helped a ton. Excedrin Extra Strength: Bottle with him that he thinks consumed dose from 03Mar2021: Lot: 610197, Expiry: Apr2022, UPC: Unknown, box discarded, Distributed by Consumer Health.  No follow-up attempts are possible. No further information is expected.