Received Jun 27, 2025
| Type | Name | Manufacturer | Dose | Lot | Route / Site |
|---|---|---|---|---|---|
| RAB | RABIES (RABAVERT) | NOVARTIS VACCINES AND DIAGNOSTICS | 2 | Unknown | IM / LA |
Half an hour after the vaccination with second dose of RabAvert the patient got horrible acid reflux like almost wanted to vomit; Half an hour after the vaccination with first dose of RabAvert the patient got horrible acid reflux like almost wanted to vomit; Case reference number US-BN-2024-002908 is a spontaneous case initially received from other health care professional via Med Communication (reference number: USBAV24-3310) on 16-Dec-2024 and concerns an adult female, patient of unspecified age. The patient's s medical history and concomitant medication details were not provided. The patient was not pregnant. The patient' current condition included polycystic ovarian syndrome (PCOS), Hashimoto's, acid reflux. On unspecified date, patient was bitten by dog that hadn't gotten a rabies shot in ten years. On 12-Dec-2024, unknown of time after dog bite, the patient received first dose of RabAvert vaccine along with its constituent parts prefilled syringe, needle for injection and needle for reconstitution (batch number: unknown) one milliliter, intramuscularly in the left arm for post-exposure and co-suspect vaccine Immunoglobulin (brand name: unknown; batch number: unknown), at unknown dose, route or site of administration for unknown indication. On the same date, half an hour after the first dose the patient experienced extremely bad acid reflux like almost wanted to vomit. On 15-Dec-2024, unknown of time after dog bite, the patient received the second dose of RabAvert vaccine along with its constituent parts prefilled syringe, needle for injection and needle for reconstitution (batch number: unknown) one milliliter, intramuscularly in the left arm. On the same date, half an hour after the first dose the patient experienced that same horrible acid reflux like almost wanted to vomit as it is from the first dose. The patient had been taking famotidine, 40-80 milligrams and it didn't help. At the time of the initial report, the patient didn't recover from the event of 'acid reflux'. The reporter assessed the 'acid reflux' after first and second dose of RabAvert as non-serious and possibly related to the product of RabAvert. No further information was provided.; Reporter's Comments: An adult female patient of unspecified age experienced a non-serious event of extremely bad acid reflux like almost wanted to vomit on the day 0 after the patient received the first dose and after the patient received the second dose of RabAvert vaccine for post-exposure. Gastrooesophageal reflux disease is unlisted and unexpected for RabAvert per CCDS v4 and USPI. The patient's medical history and concomitant medication details were not provided, was not pregnant, and current condition included polycystic ovarian syndrome (PCOS), Hashimoto's, acid reflux. The patient didn't recover. Considering suggestive temporal relationship and since the contributory role of the suspect vaccine cannot be excluded, the reported events have been considered as related to RabAvert. This case is considered as non-serious.; Sender's Comments: An adult female patient of unspecified age experienced a non-serious event of extremely bad acid reflux like almost wanted to vomit on the day 0 after the patient received the first dose and after the patient received the second dose of RabAvert vaccine for post-exposure. Gastrooesophageal reflux disease is unlisted and unexpected for RabAvert per CCDS v4 and USPI. The patient's medical history and concomitant medication details were not provided, was not pregnant, and current condition included polycystic ovarian syndrome (PCOS), Hashimoto's, acid reflux. The patient didn't recover. Considering suggestive temporal relationship and since the contributory role of the suspect vaccine cannot be excluded, the reported events have been considered as related to RabAvert. This case is considered as non-serious.
Acid reflux (oesophageal); Hashimoto's disease; Polycystic ovarian syndrome
Medical History/Concurrent Conditions: Dog bite
Immunoglobulin