Received Jan 15, 2026
| Type | Name | Manufacturer | Dose | Lot | Route / Site |
|---|---|---|---|---|---|
| FLUX | INFLUENZA (SEASONAL) (NO BRAND NAME) | UNKNOWN MANUFACTURER | UNK | No batch number | — |
Body was very sensitive; Bleed; Had diarrhea; Multiple bowel movements; This spontaneous case initially received on 08-Dec-2025, was reported by a non health professional and concerns an elderly female patient. Past medical history included Had lost a lot of weight, Gained weight. At the time of the event the patient had Ulcerated colitis. Administration of company suspect drug: On an unknown date in Sep-2025, the patient received INN Flu Vaccine Seasonal for Unknown indication, Dose regimen: Not reported, Route of administration: Not reported, Anatomical location: Not reported, Lot number: No batch number available, and will be requested upon follow-up. No additional suspect drugs. Adverse reactions/events and outcomes: On Sep-2025, the patient experienced Bleed (Medically Significant, outcome: Unknown), Had diarrhea (outcome: Recovered / Resolved), Multiple bowel movements (outcome: Recovered / Resolved). On an unknown date, the patient experienced Body was very sensitive (outcome: Not Reported). Case was upgraded to serious upon company assessment of the reported event's (Bleed) clinical significance. Consumer called and stated per verbatim that the consumer got an adverse reaction to taking the Seqirus regular flu shot in September given by specialty pharmacy to where the consumer lived in the consumer's facility. The consumer also had a colitis which was in remission, the consumer was really doing good. The consumer was so happy. Took the flu shot and the next day the consumer started to bleed and the consumer had diarrhea. And then the consumer was back to day one, where the consumer had multiple bowel movements and diarrhea. And the consumer was really upset. Nobody advised the consumer that this could affect the consumer's colitis condition. What could be done for the consumer at that point? It was the flu shot, but it wasn't the super flu, it was just the regular flu shot. Because the super flu which the consumer took years ago affected the consumer. And the consumer couldn't take that. But the regular flu shot which the consumer had been taking every year was fine. But then the consumer developed an ulcerated colitis condition and that year the consumer took the flu shot. And that was when the consumer had an adverse reaction to it. And nobody advised the consumer that this could affect the consumer's condition. And the consumer was really suffering since September. The consumer hoped it finally got out of the consumer's system, the consumer didn't know if it did enough damage already. The consumer had no idea, specialty pharmacy had to be contacted, they would have that information. The consumer was sure. The consumer thought they would keep it. They didn't tell the consumer what kind of batch, they just came and they gave it to the consumer. They didn't give the consumer anything. Just signed the whatever form and that was it. The consumer knew the date was September. The consumer didn't recall the date. But it was in September at the [withheld] Club which was now called [withheld] Senior Residence. The consumer was on a herbal solution. The consumer wasn't taking the medication that erupted the consumer's colitis condition. The consumer was taking some sort of solution that didn't work. The consumer was on the herbal solution that did, and the consumer was in remission for months, the consumer would say for years. Until the consumer took the flu shot. And the consumer was wondering what could be done for the consumer at that point if anything. How to deal with it. The consumer told something. Taking medication didn't work. The consumer could not take the medication that they advised which the consumer was on. They gave the consumer an infusion which the consumer stopped. The consumer took an herbal remedy for it. And went into remission. The consumer stopped having diarrhea, the consumer stopped having multiple bowel movements. The consumer had lost a lot of weight, the consumer gained weight. Only after the consumer took this herbal solution. Then the consumer took the flu shot. Back to base one again. So the consumer didn't know what could be done for the consumer at that point but the consumer was really... There was nothing advising the consumer that it could affect the consumer. And the consumer was wondering if the consumer should call the Bureau or something. Because this was unacceptable. If somebody told the consumer that it could affect the consumer's ulcerated colitis condition, the consumer would never have taken it. The consumer's body was very sensitive. Was there anything anybody could do for the consumer? Or just told the consumer to go to the doctor. Which when the consumer called the pharmacy and the consumer asked them how long the flu shot would stay in the consumer's system they said it would probably stay through March. So if that was true then the consumer would have to suffer with this until March and hopefully it didn't do any damage and then the consumer could reverse the symptoms. Me too. The consumer was very sorry. The consumer spoke to the [inaudible] somebody to advise the consumer that it could affect the consumer's condition. Because if the consumer had the choice not to take the flu shot the consumer would not have taken the flu shot [inaudible]. So what was said was to call the pharmacy. What did they tell the consumer to do, just go to the doctor? [laughs] Yeah well. First of all, when was it going to get out of the consumer's system. Was this true that it could stay in the consumer's system till March or could it stay for longer than that? Did they have any idea how long this flu shot would remain within the consumer? Did they have any idea on that? The consumer didn't know, the consumer wished the consumer knew how to take the flu shot out of the consumer's system. Because then maybe the consumer could recover. Or maybe the consumer wouldn't, maybe it just broke [inaudible]. The consumer was sure they wouldn't help the consumer on that. Believe the consumer. The consumer spoke to the pharmacy and they said that it would be in the consumer's system until March. A health care provider wouldn't have any more information than the pharmacy. Well the consumer saw that there was really no help for the consumer. Okay, the consumer thought the consumer would call the Bureau. All right. Anyway that was all the consumer had to say. INN Flu Vaccine Seasonal action taken: Not Applicable Reporter's assessment: The primary reporter did not provide a seriousness or causality assessment for the events.; Reporter's Comments: Causality: Due to the spontaneous nature of the case, events are considered related for reporting purposes. Considering plausible temporal relationship for events diarrhea, bleeding and multiple bowel movements (1 day post vaccination). However, underlying condition of ulcerated colitis provides more plausible/alternative explanation (site of bleeding not specified). There is insufficient information regarding event body was very sensitive to perform in depth analysis (event onset date, temporality, confirmed/final diagnosis, relevant medical history, unclear etiology, etc.).
Colitis ulcerative
Medical History/Concurrent Conditions: Weight gain; Weight loss; Comments: None