Received Oct 15, 2025
| Type | Name | Manufacturer | Dose | Lot | Route / Site |
|---|---|---|---|---|---|
| COVID19 | COVID19 (COVID19 (UNKNOWN)) | UNKNOWN MANUFACTURER | UNK | — | OT |
I got really, really cold; I was shaking though; I was shivering and my teeth were chattering; I was tired from it. I mean, it tired me out; Initial information received on 02-Oct-2025 regarding an unsolicited valid non-serious case received from patient This case involves a 68 years old female patient who got really, really cold, shivering and my teeth were chattering, shaking though, and tired from it which means it tired her out after receiving NVX-COV2705 (omicron JN.1) adjuvanted vaccine [Novavax Covid-19 Vaccine, Adjuvanted]. The patient's past medical history included Pain in extremity and Feeling cold on unknown date and COVID-19 in Aug-2024 The patient's past medical treatment included Paxlovid in 2024 for covid. The patient's past vaccination(s) included moderna for covid-19 immunization. The patient's past family history was not provided. At the time of the event, the patient had ongoing Neoplasm malignant. On an unknown date, the patient received unknown dose number of suspect NVX-COV2705 (omicron JN.1) adjuvanted vaccine Injection (with unknown dose and lot number, strength and expiry date) via unknown route in unknown administration site for covid-19 immunization. On an unknown date the patient reported that she got really, really cold (feeling cold), had shivering her teeth were chattering (chills), had shaking though (tremor), and was tired from it. She mean, it tired her out (fatigue) (unknown latency). It was reported that "patient had a strong reaction that evening and what happened was patient got really, really cold, really cold. Patient put on sweats and a heavy bathrobe, and we turned the electric blanket on in the bed, and patient was shaking though, Patient was shivering, and her teeth were chattering, and patient was just really, really, really cold and patient got into bed with lots of blankets and the electric blanket, and her husband laid down with me and held me. Patient was shivering, she was really shivering, and it was over in 40 minutes, done, no more reaction and she was tired from it. She means, it tired her out. She went to be the next day, perfectly fine. No, no hangover and nothing. But she did have a past 40 minutes of, you know, shivering and teeth chattering and feeling really, really cold. So, she wants to have another Novavax. It's been 13 months since she had COVID and Paxlovid and it's been years since she had my last Novavax. I sort of feel, and she don't know, but she sort of think that my reaction was so strong because she had had COVID and Paxlovid only eight weeks before. She not a medical person, but she pretty sure she read in places that having had COVID before getting a vaccine can increase your reaction. She would like to know if you think that it's possible that getting the vaccine so close to having been ill with COVID and, you know, probably having a lot of antibodies in me from both Paxlovid and COVID caused the extreme reaction that occurred, and she say extreme, it was worse than the other reactions, but it only lasted for 40 minutes, we timed it. So, that's what she asking about. Before you go any further, she already talked to my doctor. Her doctor is useless because she said she's never heard of anyone getting chills from a vaccine. You know, that was not a helpful thing because Moderna, Pfizer, and Novavax, they all say you can get chills. And she think being cold is a chill, but nobody will tell her if that's chills, what she went through. Did she go through chills" Action taken: Not applicable. It was not reported if the patient received corrective treatment for the events. She put on sweats and a heavy bathrobe, and turned the electric blanket on in the bed. At time of reporting, the outcome was Recovered / Resolved on an unknown date for all events.
Cancer
Medical History/Concurrent Conditions: COVID-19; Feeling cold; Painful arm