Received May 5, 2025
| Type | Name | Manufacturer | Dose | Lot | Route / Site |
|---|---|---|---|---|---|
| COVID19 | COVID19 (COVID19 (PFIZER-BIONTECH)) | PFIZER\BIONTECH | 1 | LM2223 | LA |
| FLU3 | INFLUENZA (SEASONAL) (FLUAD) | SEQIRUS, INC. | UNK | 388466 | LA |
twitching in the muscles in his face and neck; wiggle his ears. Initially he was not able to wiggle the right side ear, he could hardly move it to where you could see it wiggle; headache behind his right ear; atrophy of his right arm bicep; blood glucose went up; Bell's palsy/face was drooping on his right side; This is a spontaneous report received from a Consumer or other non HCP from medical information team. A 79-year-old male patient received BNT162b2 omicron (kp.2) (COMIRNATY (2024-2025 FORMULA)), on 29Aug2024 as dose 1, 0.3 ml single (Lot number: LM2223) at the age of 79 years, in left arm for covid-19 immunisation; influenza vaccine inact sag 3v (FLUAD), on 29Aug2024 as dose number unknown, single (Lot number: 388466), in left arm for immunisation. The patient's relevant medical history included: "Gout", start date: 1983 (ongoing); "High cholesterol", start date: 2004 (ongoing); "Pacemaker", start date: 2017 (ongoing); "Bladder cancer and surgery", start date: 2019 (unspecified if ongoing); "Bladder cancer and surgery", start date: 2019 (unspecified if ongoing); "Has an atrophy of his right arm bicep" (unspecified if ongoing); "for his heart/blood thinner" (ongoing); "for his thyroid" (ongoing); "Acid reflux (esophageal)" (unspecified if ongoing). Concomitant medication(s) included: ATORVASTATIN taken for blood cholesterol increased, start date: 2004 (ongoing); ELIQUIS taken for anticoagulant therapy, cardiac disorder, start date: Oct2016 (ongoing); DOFETILIDE taken for cardiac disorder, start date: Sep2017 (ongoing); PROBENECID taken for gout, start date: 1983 (ongoing); LEVOTHYROXINE taken for thyroid disorder, start date: 1987 (ongoing); OMEPRAZOLE taken for gastrooesophageal reflux disease, start date: 2010. The patient also took other concomitant therapy. Vaccination history included: pfizer biontech vaccines (dose number unknown; initial, the next set, and all 7 or 8 of them), administration date: 09Sep2023, for COVID-19 immunization; pfizer biontech vaccines (dose number unknown; initial, the next set, and all 7 or 8 of them), administration date: 28Mar2024, for COVID-19 immunization; Pfizer biontech vaccines (primary series completed; initial, the next set, and all 7 or 8 of them), for COVID-19 immunization; Pfizer biontech vaccines (dose number unknown; initial, the next set, and all 7 or 8 of them), for COVID-19 immunization. The following information was reported: BELL'S PALSY (medically significant) with onset 03Sep2024, outcome "recovering", described as "Bell's palsy/face was drooping on his right side"; MUSCLE TWITCHING (non-serious), outcome "unknown", described as "twitching in the muscles in his face and neck"; EAR DISORDER (non-serious), outcome "unknown", described as "wiggle his ears. Initially he was not able to wiggle the right side ear, he could hardly move it to where you could see it wiggle"; HEADACHE (non-serious), outcome "unknown", described as "headache behind his right ear"; ATROPHY (non-serious), outcome "unknown", described as "atrophy of his right arm bicep"; BLOOD GLUCOSE INCREASED (non-serious), outcome "recovered", described as "blood glucose went up". The event "bell's palsy/face was drooping on his right side" required emergency room visit. The patient underwent the following laboratory tests and procedures: Blood glucose: went up; went back down to normal; testing: everything was normal. Therapeutic measures were taken as a result of bell's palsy, headache. Clinical course: The patient informed that his pharmacist administered the covid vaccine he also got the annual flu shot. He has had all of the covid vaccines, initial, the next set, and all 7 or 8 of them, stated that they were all the Pfizer BioNTech vaccines. Up through the vaccine that he had in 09Sep2023 and then 28Mar2024, prior to the one he just got he has had no reaction or anything. At the end of August, 29Aug2024, later in the beginning of Sep2024 he developed Bell's palsy. Since he had no experience with Covid vaccines prior, it was rather suspect that the vaccine he received in Aug2024 caused him to get bell's palsy. It could be stress or something else. On 03Sep2024, he was having lunch with his daughter and when he took off his N95 mask, his daughter said his face was drooping on his right side and they went to the Emergency Room and they ruled out stroke and told him he had Bell's palsy. They normally give Acyclovir, and they gave him that for a period of time and also gave him prednisone, a corticosteroid. After researching if you take a corticosteroid within 2 weeks after a Covid vaccine, was said that the vaccine may not be as effective. When he went to pick up his prescriptions on Friday, they offered him to take the same covid vaccine that he had in Aug2024, a repeat of the same dose. He told them he had Bell's palsy and the told him to report it to Pfizer. Also told him to speak to his physician about getting another dose. They did not show anything that it causes bell's palsy, but he could be a rare case. He still has a little droop in his smile, but not much. He was getting some twitching in the muscles in his face and neck, like his muscles were trying to wake up. Also reported that he can wiggle his ears. Initially he was not able to wiggle the right side ear, he could hardly move it to where you could see it wiggle. He also had a headache behind his right ear, but was not bad, just a little bit. Treated with Tylenol that seemed to help. Overtime he can now wiggle his ear. Has an atrophy of his right arm bicep and he got his shots in the left arm. They did routine testing and everything was normal, because of the shock of it, blood glucose went up, but went back down to normal. He said that there was no interaction between the flu shot and corticosteroid. The reporter informed that the NDC was 00069-2432-10.
Artificial cardiac pacemaker user; Gout; Heart disorder; High cholesterol; Thyroid disorder
Medical History/Concurrent Conditions: Acid reflux (esophageal); Atrophy; Bladder cancer; Bladder operation
ATORVASTATIN; ELIQUIS; DOFETILIDE; PROBENECID; LEVOTHYROXINE; OMEPRAZOLE
Test Name: blood glucose; Result Unstructured Data: Test Result:went up; Test Name: blood glucose; Result Unstructured Data: Test Result:went back down to normal; Test Name: testing; Result Unstructured Data: Test Result:everything was normal