Received May 19, 2025
| Type | Name | Manufacturer | Dose | Lot | Route / Site |
|---|---|---|---|---|---|
| COVID19 | COVID19 (COVID19 (PFIZER-BIONTECH)) | PFIZER\BIONTECH | UNK | LM2223 | LA |
| UNK | VACCINE NOT SPECIFIED (NO BRAND NAME) | UNKNOWN MANUFACTURER | UNK | 388466 | LA |
Bell's palsy / his face was drooping on his right side; He was getting some twitching in the muscles in his face and neck; He also had a headache behind his right eat; Has an atrophy of his right arm bicep and he got the his shots in the left arm; His blood glucose went up; This spontaneous case, initially received on 28-Apr-2025, was reported by a non health professional and concerns a male patient. Weight: 68.49 kg; Height: 165 cm Past medical history included Pacemaker, Bladder cancer and surgery, Bladder cancer and surgery. At the time of the event the patient had Gout, High cholesterol. Concomitant medication: refer to appropriate report section. Administration of company suspect drug: On 29-Aug-2024, the patient received Fluad (TIV) for Routine vaccination, Dose regimen: 0.5 ml, Route of administration: Not reported, Anatomical location: Left arm. Lot number: 388466. Non-company suspect drugs: Comirnaty (Tozinameran), Indication: Routine vaccination. Adverse reactions/events and outcomes: On 03-Sep-2024, the patient experienced Bell's palsy / his face was drooping on his right side (Medically Significant, outcome: Recovering / Resolving). Associated symptoms included: He was getting some twitching in the muscles in his face and neck, He also had a headache behind his right eat. Case was upgraded to serious upon company assessment of the reported events clinical significance. On Sep-2024, the patient experienced Has an atrophy of his right arm bicep and he got the his shots in the left arm (outcome: Recovering / Resolving), His blood glucose went up (outcome: Recovering / Resolving). Caller was a consumer calling about the medication Covid-19 2024-2025 and reported that at the same time that his pharmacist administered the covid vaccine he also got the annual flu shot. The flu shot was the Fluad adjuvanted 65 plus. 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 same vaccines. Up through the vaccine that he had in 09-Sep-2023 and then 28-Mar-2024, prior to the one he just got he has had no reaction or anything. On 29-Aug-2024, 5 days later in the beginning of Sep-2024 he developed Bell's palsy. In looking in the literature, the biopharma literature, there may be some studies from 2022, a small group of people may develop Bell's palsy after receiving the Covid vaccines. They might have seen some cases, but since he had no experience with Covid vaccines prior, it was rather suspect that the vaccine he received in Aug-2024 caused him to get bell's palsy. It could be stress or something else. On 03-Sep-2024, 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, take a corticosteroid within 2 weeks after a Covid vaccine, it 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 Aug-2024, a repeat of the same dose. He told them he had Bell's palsy and the told him to report it to the manufacturer. 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. Online said that there may be a mild reaction that makes it less effective if corticosteroids are taken within 2 weeks of receiving the covid vaccine. Asked if this was true. 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 are 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. Dose site: Has an atrophy of his right arm bicep and he got the his shots in the left arm. Testing: They did routine testing and everything was normal, because of the shock of it, his blood glucose went up, but went back down to normal. He said that there is no interaction between the flu shot and corticosteroid. Reporter got the vaccine back at the end of 29-Aug-2024 at the same with the flu shot. 5 days after got the Covid vaccine, patient came down with Bell's Palsy and went to the ER they ruled out stroke and everything else and they said it was Bell's Palsy. So they prescribed Acyclovir for a therapy for adult palsy. And also for the first 5 days, they prescribed Prednisone which is a corticosteroid. Patient asked if there was any interference that the Prednisone would have with getting the Pfizer vaccine. Patient did not start to use the Prednisone until the 4-Sep. Only took it for 5 days and the dose was 20mg 3 times a day, total dose for each of the 5 days was 60mg. Prednisone not starting on Tuesday , the 3rd, 4th, 5th, 6th, 7th and the 8th and stopped it after that. Fluad (TIV) action taken: Not Applicable Treatment medication: Acyclovir, Prednisone, Tylenol Reporter's assessment: The reporter considered the event as non-serious and did not provide the causality of the events.; Reporter's Comments: Causality: Due to the spontaneous nature of the case, it is considered related for reporting purposes. Related considering plausible temporality (1 month after receiving vaccine). Past medical history of Pacemaker, Bladder cancer and surgery, Bladder cancer and surgery.Underlying conditions of Gout, High cholesterol provide plausible etiology in occurence of events. Related for event vaccination site atrophy considering anatomical proximity. Brighton collaboration criteria is assessed as level 4 due to insufficient information provided.
Gout; High cholesterol
Medical History/Concurrent Conditions: Bladder cancer; Bladder operation; Pacemaker insertion (cardiac)
Atorvastatin; Eliquis; Dofetilide; Probenecid; Levothyroxine; Omeprazole