Received Nov 6, 2025
| Type | Name | Manufacturer | Dose | Lot | Route / Site |
|---|---|---|---|---|---|
| COVID19 | COVID19 (COVID19 (UNKNOWN)) | UNKNOWN MANUFACTURER | UNK | — | OT / RA |
Horribly sick; Dizzy; Feverish; Headache; Arm hurt top to bottom; Initial information received on 21-Oct-2025 regarding an unsolicited valid non-serious case received from a consumer/Non-Healthcare Professional. This case involves a 66 years old female patient (14.224 cm and 81.82 kg) who was horribly sick, dizzy, feverish, headache and arm hurt top to bottom after receiving NVX-COV2705 (omicron JN.1) adjuvanted vaccine [Nuvaxovid JN.1]. The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided. At the time of the event, the patient had ongoing Drug hypersensitivity with Codeine. Patient ever had an AE following any previous vaccine; Probably 2021 or 2022, mRNA Covid vaccine (Brand name: Moderna and Pfizer) Consumer stated she had Novavax Covid vaccine in September 2024, and March 2025 Concomitant medications included Multivitamin Centrum Women 50+ , Atorvastatin 10mg at night, calcium and Vit D3 in the morning , Loratadine 10mg daily in the morning. On 02-Oct-2025, the patient received unknown dose of suspect NVX-COV2705 (omicron JN.1) adjuvanted vaccine, Solution for injection in pre-filled syringe, 5ug (lot number and expiry date not reported) via unknown route in the right arm. On 02-OCT-2025 same day the patient was horribly sick (illness), dizzy (dizziness), feverish (pyrexia), headache and arm hurt top to bottom (pain in extremity). It was reported that "I was completely nonfunctional, said to my husband, don't know if I'm going to need to go to an ER. felt horrible sick. And it, again, is so scary that I feel like now I'm afraid to try it again because one of these times I'm not going to recover. The second day was a little -Saturday was a little better. I went for a short walk outside, came back in. I was going to go to my granddaughter's soccer, and I realized I just can't go. I'm too sick. I just don't feel well. So I just need a shot that works that doesn't make me sick. I really want to be vaccinated for COVID, but I don't know if you guys can tell me that there's something different in this new 2526 vaccine that was different from the one a year before or not. But I just wanted to share my reaction in case it helps other people. The first vaccines in about 2021, or 2022 when those Moderna and Pfizer did not work for me. And, you know, I've never had reactions to any other vaccine. I've had RSV, pneumonia, shingles, you know. I've not had a problem like these COVID shots give me. And, again, I've only had COVID two times in my life, but the first time I was sick 21 days, in bed, fever, chill, nonfunctional. That's why I would like to be able to be vaccinated for this. But I'm afraid now that I had a problem with your vaccine this time. I was vaccinated, both Moderna and Pfizer, the first two Moderna and then the Pfizer booster. So I thought maybe I had protection, and it was probably, you know, some months after that I went to a concert. And that was like a Thursday, and Saturday I woke up sick. It would have been probably might have been in the fall. I can't remember the dates, but it would have been probably 2023. You know, or it might have been the fall of 22 or 23. I'm the type of person in the beginning I was extremely careful. I wore a mask faithfully. I stayed away from crowds. Then finally when I was vaccinated, I went ahead and went to this concert. I got COVID. I was horribly sick. And then the only other time would have been almost two years ago this coming February. I was sick for eight days that time. So it would have been February of 2024" The patient ever tested positive for covid-19: Months after having mRNA Vaccine, fall of 2022 or 2023, and in February 2024 (method of COVID-19 diagnosis was not known) Action taken: Not applicable. Treatment given: Only Tylenol taken. At time of reporting, the outcome was Unknown for all events.
Drug allergy (Codeine)
Multivitamin active woman 55+; Atorvastatin; CALCIUM & VITAMIN D3; Loratadine