Received Oct 15, 2025
| Type | Name | Manufacturer | Dose | Lot | Route / Site |
|---|---|---|---|---|---|
| COVID19 | COVID19 (COVID19 (UNKNOWN)) | UNKNOWN MANUFACTURER | 1 | 0315M100FC | OT / LA |
woke up with shake and chills; 103 fever; woke up with shake and chills; the entire area became raised and hard; injection site was brick red; got like a COVID arm itching; the entire area became raised and hard; Initial information received on 29-Sep-2025 regarding an unsolicited valid non-serious case received from a Patient. This case involves a 78 years old female patient (161.29 cm and 68.04 kg) who experienced woke up with shake and chills, the entire area became raised and hard, 103 fever, injection site was brick red, got like a covid arm itching after receiving NVX-COV2373 (original) adjuvanted vaccine [Nuvaxovid]. The patient's past vaccination(s) included MODERNA COVID-19 VACCINE (Fever ; site injection discomfort including redness and pain), COVID-19 VACCINE (Fever ; site injection discomfort including redness and pain) and NUVAXOVID in 2024 with irritation at the injection site, but nothing really horrible. The patient's past medical history, medical treatment(s) and family history were not provided. Concomitant medications included INFLUENZA VACCINE INACT SAG 3V (FLUAD) for Immunisation. On 26-Sep-2025, the patient received 0.5 ml dose (dose 1) of suspect NVX-COV2373 (original) adjuvanted vaccine , Injection (lot 0315M100FC and expiry date: 31-DEC-2025) via intramuscular route in the left arm for Prophylactic vaccination. On 27-Sep-2025 the patient woke up with shake and chills (tremor) (chills) and 103 fever (pyrexia) (latency: 1 day). On unknown date In Sep-2025 the patient reported that the entire area became raised and hard (vaccination site induration) (vaccination site swelling) , injection site was brick red (vaccination site erythema) and got like a covid arm itching (vaccination site pruritus) (few days: latency). It was reported that "Patient had the Novavax vaccine last year and without incident maybe a little, you know, it's an irritation at the injection site, but nothing really horrible, you know, just very mild, no problem. I went ahead and I had the shot again this year on Friday, this past Friday. Saturday night,I would say, or early Sunday morning, actually, it was like around 1 a.m. I woke up with shake and chills, 103 fever. The injection site was brick red and I got like a COVID arm itching and it was similar to what I had with Moderna, which is why I didn't take Moderna. last night, my husband took me to the (Emergency Room) ER in with the fever continuing. And they advised me to possibly take Keflex 500 milligrams four times a day for five days. The fever broke and I am afebrile now but the itching, the redeness, it's still there. It's still on my arm not as red and not as large an area, but itching, you know, at the injection concentrated on the injection site. When this started, the entire area became raised and hard. Now the raised section is much less but I'm reporting that it happened. Yeah, I guess you don't, you wouldn't have medical information for, you know, your position at the company is, you know, to get, gather information. But I don't understand the difference between last year's shot and this year's shot reaction. In other words, felt comfortable getting it this year and I actually ran once I found out they had it. We were going to go someplace on Saturday so I wanted to make sure to get my shot before. I wasn't worried at all because the year before when I had it it was like a big nothing burger, you know al little bit but no fever no horrible reaction just a little slight irritation which is okay. This was not okay, this was quite different. I read all the descriptions, you know, that were available on the web of possible reactions, but when I was fine last year without any really bad reaction and this year I end up in an ER. So, what do I do now: I can't take the Moderna and I can't take the Pfizer, I have a major reaction and so now the Novavax was my ace in the whole so to speak and now what do I do: if they change, they must have changed something in terms of what they're either an additive that they changed, either to cheapen it or whatever they did. They should know that this is what's happening. So, I am reporting it now. My husband had the same thing and he didn't have a reaction. What I went through was very, very similar to what I had been through with the Moderna. With the Moderna I had 103 plus fever but it lasted longer. I remember I was very ill with the Moderna. I had COVID arm on the whole upper part of my arm, not just a large round circle, the whole upper arm, all the way down to the elbow and that lasted for a couple of weeks, that was the Moderna. Well, my husband's a physician, but he saw this, he was afraid I was getting an access and it was raised so, he took me to the ER and drove me all the way to the best ER here. I am on KeFlex, cephalexin is the generic I am on 500mg four times a day for five days. My husband was afraid that I was developing cellulitis and that's why he took me to the ER. I woke up with a high fever. You know, when you have high fever, if I can't think straight, it's always very high, shaking chills, and, you know, and even with two Motrin and then next hour, two Tylenols, I never got under 100 and almost 101. In other words it went all the way up to almost 103 and then even with the Tylenol and the Motrin, I couldn't get it below 100 and almost 101. I was thinking, what did they do to change it: I don't know if taking it two days after or three days after the flu shot mattered. But my husband didn't have this reaction." Action taken: Not applicable. The patient was treated with Cefalexin (Keflex), Paracetamol (Tylenol) and Ibuprofen (Motrin) for Pyrexia. At time of reporting, the outcome was Recovering / Resolving for the event the entire area became raised and hard, was Unknown for the event (tremor, chills, vaccination site pruritus and vaccination site induration, vaccination site swelling), was Recovered / Resolved on an unknown date for the event 103 fever, was Not Recovered / Not Resolved for the event vaccination site erythema.
FLUAD