Age: 76.0
Sex: M
Vaccine: COVID19, FLU3
Symptoms: Pain, Product use issue, Tremor, Vascular pain
Clinical narrative: most recent Covid booster dose which was on 20Sep2022; received the Fluzone HD vaccine the same day he received the most recent Covid booster dose which was on 20Sep2022; extreme pain in the small of his back; extreme pain in the small of his back, and it traveled toward his neck to his carotid artery; extreme pain in the small of his back, and it traveled toward his neck to his carotid artery; headache; tiredness; excruciating pain; he started shaking; 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 76-year-old male patient received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), on 20Sep2022 as dose 5 (booster), single (Lot number: GH9694) at the age of 76 years, in left arm for covid-19 immunisation; influenza vaccine (FLUZONE [INFLUENZA VACCINE]), on 20Sep2022 as dose number unknown, 0.7 ml single (Lot number: PF2022-23), in left arm for immunisation. The patient's relevant medical history included: "high blood pressure" (ongoing), notes: high blood pressure began prior to covid vaccine; "diabetes" (ongoing), notes: Diabetes began prior to covid vaccine; "Cirrhosis liver" (ongoing), notes: Cirrhosis liver began prior to covid vaccine. Concomitant medication(s) included: METFORMIN taken for blood pressure increased, diabetes mellitus (ongoing). Vaccination history included: BNT162b2 (DOSE 1, SINGLE, lot FH9894), administration date: 08Apr2020, when the patient was 73-year-old, for Covid-19 Immunization; BNT162b2 (DOSE 2, SINGLE, lot EL9261), administration date: 20Jan2021, when the patient was 74-year-old, for Covid-19 Immunization; BNT162b2 (DOSE 3, SINGLE, Lot: EM9809), administration date: 10Feb2021, when the patient was 74-year-old, for Covid-19 Immunization; BNT162b2 (DOSE 4, SINGLE, Lot: ER8733), administration date: 05Oct2021, when the patient was 75-year-old, for Covid-19 Immunization; Flu (he never ever with any vaccine he has taken for the flu or pneumonia vaccine, he has never had any kind of reaction let alone this regarding the reported events), for Immunization; Pneumonia vaccine (he never ever with any vaccine he has taken for the flu or pneumonia vaccine, he has never had any kind of reaction let alone this regarding the reported events), for Immunization. The following information was reported: PAIN (non-serious) with onset 20Sep2022, outcome "recovered" (21Sep2022), described as "excruciating pain"; BACK PAIN (non-serious) with onset 20Sep2022, outcome "recovered" (21Sep2022), described as "extreme pain in the small of his back"; NECK PAIN (non-serious), VASCULAR PAIN (non-serious) all with onset 20Sep2022, outcome "recovered" (21Sep2022) and all described as "extreme pain in the small of his back, and it traveled toward his neck to his carotid artery"; TREMOR (non-serious) with onset 20Sep2022, outcome "unknown", described as "he started shaking"; HEADACHE (non-serious) with onset 20Sep2022, outcome "not recovered"; INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (non-serious) with onset 20Sep2022, outcome "unknown", described as "most recent Covid booster dose which was on 20Sep2022"; PRODUCT USE ISSUE (non-serious) with onset 20Sep2022, outcome "unknown", described as "received the Fluzone HD vaccine the same day he received the most recent Covid booster dose which was on 20Sep2022"; FATIGUE (non-serious) with onset 20Sep2022, outcome "recovered" (2022), described as "tiredness".  Additional Information: He experienced shortly after the same day extreme pain in the small of his back, and it traveled toward his neck to his carotid artery and he still has a headache. His doctor said they put something a little different in this vaccine that the other ones did not have. Is that correct? And is it safe for him to get the vaccine again if he should need it? He was told this vaccine is a little different because of Omicron. He also received the Fluzone HD vaccine the same day he received the most recent Covid booster dose which was on 20Sep2022. Caller did not receive a copy of the Fact Sheet for Patients.  He had no side effects with the doses he received of the previous version of the vaccine. He says hes "still a little bit on the rocks about it."  Is there any information about the vaccine that would be given next year?  His doctor said they are thinking this will be an annual vaccine people will get. No PQC Present, Other Conditions: Yes. No Investigations and No Other Products. Had the three shots already for the Pfizer Covid vaccine and this was the 4th which is the booster and never had any problems at all with any of those but this last one was really bad and it was administered on 20Sep2022; this time he got both of them together for the flu shot and the covid shot and his wife got hers at the same exact time and there are no problems with her. He got the flu and covid vaccine at (Pharmacy name withheld) and usually gets them at the (State name withheld) and they had nothing available so he went there to the (Pharmacy name withheld). About probably 3 minutes after he got the shot they walked outside got in the car and went out to the road and all of a sudden the middle small of his back started tightening and it was excruciating pain in the small of his back and then all of a sudden now he was in the car driving and he said he couldn't drive as the pain was terrible; he got out of the car and fell to the ground and she was saying what should she do and he said just be quiet.He stood up not in traffic but then the pain goes from the small of his back and it was a shooting pain if you think of having like a toothache pounding pain, it was like that and went up like to the right side of his body and he could feel it traveling up towards his neck to the carotid artery and could feel it pulsing and pounding and then the pain went up to his head and was pounding like that and he figured what the hell is this. Has never had any kind of reaction not to anything so then it kind of, after maybe getting in the car to go home, started subsiding a little bit probably about 2 minutes after the sharp pain he had a little bit of pain and he got home and called the pharmacist there and told them and he said holy cow he's never heard of this before and when he got home he started shaking violently like he was freezing to death. The pain felt like this little kind of like muscle spasm then bam it hit like no pain he has ever had in his life in and he was in the car screaming.  The pain resolved and he would say all his symptoms he's having is a slight headache that could be caused by a lot of things but mostly what he experienced is confined to that day period and by the next morning most of the symptoms were gone except he was real tired next day but the tiredness is not ongoing. The headache is ongoing and he would say it is actually about the same and is not excruciating but is a light headache and it is there. Asks his wife if they got four doses of the Pfizer covid vaccine or did they get five and confirmed they got 5 doses and this one is his new one on 20Sep2022.  He takes a medication for high blood pressure and diabetes which is Metformin and stuff like that and began taking Metformin and was diagnosed with diabetes and high blood pressure years ago. Has not had treatment for the reported event and actually called his doctor the next day and asked if he was having any real bad symptoms from it and he said no and this just was like an all of a sudden type thing and his doctor said to watch it and if he gets sick then go to the emergency room. Flu vaccine: Got the Fluzone HD 65 plus with what may be handwritten lot of PF2022-23 and then it says injection 0.7mL and he has no further details for lot, expiry date or NDC. Vaccine was not Administered at Facility. No Emergency Room Visit, No Physician Office visit. No Prior Vaccinations (within 4 weeks). No AE(s) following prior vaccinations. Relevant Tests: None. Had no treatment and he should have gone to the hospital like his doctor told him to but did not. He does have cirrhosis of the liver and they call it fatty whatever of the liver and it has progressed to cirrhosis and is not at any stage now and he does not know if this is anything for the absorption of medicine or anything like that but to note it and he has had the cirrhosis for many many years. The only thing that he was kind of concerned about is if he has to get the covid vaccine again; he understands from what he has been told but from talking to his doctor, the doctor said they put something a little different in this covid vaccine and it is not in other ones and he does not know if that one little change did something because he never ever with any vaccine he has taken for the flu or pneumonia vaccine, he has never had any kind of reaction let alone this regarding the reported events; asks would be safe for him to get this again because they are probably saying they are thinking he has to have a booster like the flu every year now and if that is true he cannot go through this reaction as it may not be as favorable this time. For other patient the doctor was referring to as this covid vaccine has something a little different in it, he does not have patient information and no other lots, expiry dates or NDC numbers to provide and thinks the doctor just said it because probably what he was told in general for the covid vaccine itself is little different because of omicron. He has cirrhosis and he does not know if this is anything for the absorption of medicine regarding the covid vaccine.   Follow-up attempts are completed. No further information is expected.