Received Jun 27, 2025
| Type | Name | Manufacturer | Dose | Lot | Route / Site |
|---|---|---|---|---|---|
| RAB | RABIES (RABAVERT) | NOVARTIS VACCINES AND DIAGNOSTICS | 4 | Unknown | — |
Cellulitis; Intense pain after fourth dose of RabAvert; Itching fourth dose of RabAvert; Injection site swelling; Case reference number US-BN-2025-000382 is a spontaneous case initially received from consumer via Med Communications (reference number: USBAV25-0608) on 18-Mar-2025 and concerns a female patient of unspecified age. The patient's medical history and concomitant medication details were not provided. On an unspecified date, reported as on day zero, the patient received the first dose of Rabavert along with prefilled syringe, needle for injection and needle for reconstitution (batch number: unknown) at unknown dose, route and site of administration for unknown indication. On an unspecified date, unspecified time after first dose, the patient received the second dose of Rabavert along with prefilled syringe, needle for injection and needle for reconstitution (batch number: unknown) at unknown dose, route and site of administration. On an unspecified date, unspecified time after second dose, as reported, after second dose, the patient had a pretty big, localized reaction and the health care professional who was on duty had check the reaction in the emergency room and maybe was an allergic reaction or maybe was cellulitis. The patient had been given dexamethasone (as per reporter"dexamethalone"), the steroid orally and couple of other things for allergy as treatment drugs. On an unspecified date, unspecified time after second dose the patient experienced injection site swelling. On an unspecified date, 30 hours after second dose, the patient received the third dose of Rabavert along with prefilled syringe, needle for injection and needle for reconstitution (batch number: unknown) at unknown dose, route and site of administration. On an unspecified date, unknown of time after third dose of Rabavert, the patient had very minimal reaction to, the patient still had injection site swelling, as reported it was much more minor than second dose. On an unspecified date, the patient recovered from the events of injection site swelling and cellulitis On an unspecified date, the patient took the fourth dose of Rabavert along with prefilled syringe, needle for injection and needle for reconstitution (batch number: unknown) at unknown dose, route and site of administration. On an unspecified date, unknown of time after fourth dose, the patient had the pretty large reaction again with the intense pain and itching. It was asked a couple of times, because all the information online about needing a fifth dose because immunosuppression seems to be about a serious immunosuppression not a onetime dose of dexamethasone (as per reporter dexamethalone). With diminished reaction on third vaccine, 30 hours after receiving dexamethasone (as per reporter dexamethalone), there was a concerned about if the patient had full protection. On an unspecified date, the patient recovered from events of 'pain' and 'itching'. The reporter assessed seriousness for events of cellulitis, injection site swelling, 'pain' and 'itching' as non-serious. The reporter assessed the events of cellulitis, injection site swelling, 'pain' and 'itching' as possibly related to the Rabavert vaccine. No further information was provided.; Reporter's Comments: This case is concerned a female patient of unknown age/age group who experienced non-serious events of cellulitis and injection site swelling (after the second dose), pain and pruritus after the fourth dose of RabAvert vaccine for unknown indication. Cellulitis and pain are not listed per CCDS V4 and not expected per USPI. Injection site swelling is listed per CCDS V4 and expected per USPI. Pruritus is unlisted per CCDS v4 and expected per USPI. Patient's medical history and concomitant medications was not reported. All the events were resolved by the time of recipient of this case. Based on the limited information provided regarding this case, along with the latency of same day, the causal role of the suspect vaccine cannot be excluded in the occurrence of the events, hence the events cellulitis, injection site swelling, pain and pruritus are considered related to the suspect vaccine. However, lack of information regarding patient's medical history, detailed event information, treatment received, precludes the comprehensive assessment of the case. This case is considered as non-serious.; Sender's Comments: This case is concerned a female patient of unknown age/age group who experienced non-serious events of cellulitis and injection site swelling (after the second dose), pain and pruritus after the fourth dose of RabAvert vaccine for unknown indication. Cellulitis and pain are not listed per CCDS V4 and not expected per USPI. Injection site swelling is listed per CCDS V4 and expected per USPI. Pruritus is unlisted per CCDS v4 and expected per USPI. Patient's medical history and concomitant medications was not reported. All the events were resolved by the time of recipient of this case. Based on the limited information provided regarding this case, along with the latency of same day, the causal role of the suspect vaccine cannot be excluded in the occurrence of the events, hence the events cellulitis, injection site swelling, pain and pruritus are considered related to the suspect vaccine. However, lack of information regarding patient's medical history, detailed event information, treatment received, precludes the comprehensive assessment of the case. This case is considered as non-serious.
Comments: None.