Sex: F
Vaccine: RAB
Symptoms: Illness, Inappropriate schedule of product administration, Product administration error, Product dose omission issue, Viral titre
Clinical narrative: The patient received HRIG which was not supposed to be given to anyone; Exposure was on 01-Jun-2021, vaccine 1 was 08-Jun-2021; Failed to tell me I needed a second shot; Getting progressively more and more sick; Case reference number US-BN-2021-002089 is a spontaneous case report initially received on 13-Jul-2021 from a consumer via MedCommunications (reference number: USBAV21-0356) and concerns a female patient of unknown age.  The patient's concurrent condition included immunocompromised health, unspecified disability and puncture wound.  The patient's concomitant medication details were not provided. The patient's historical vaccine included Rabies vaccine with no adverse events.  On 01-Jun-2021, the patient had a puncture wound on her hand that healed fine.  On an unspecified date in Jun-2021, the patient was getting progressively more and more sick as the wound was healing.  On 08-Jun-2021, seven days after exposure, the patient received vaccine one (as reported) of RabaVert (Inactivated Rabies Virus Vaccine, batch number: not provided) at unknown dose via intramuscular route of administration for post-exposure puncture wound (explicitly coded as 'Inappropriate schedule of product administration'). They gave her the first booster since 10 years ago, then when she went in three days later for the next booster that was when they titered her.  On 11-Jun-2021, after three days, the patient received co-suspect vaccine two (as reported) of HRIG (immunoglobulin human anti-rabies) at unknown dose or route of administration for unknown indication (explicitly coded as 'Product administration error'). They failed to tell her that she needed a second shot (explicitly coded as 'Missed dose'), they gave her HRIG which they were not supposed to do, they did her titer too early, and when it came back low at two (unites were not provided), they gave her a third vaccination and told her to get a titer 30 days out.  On 30-Jun-2021, after 22 day, the patient received a third vaccine (as reported) of RabaVert (Inactivated Rabies Virus Vaccine, batch number: not provided) at unknown dose via intramuscular route of administration for post-exposure puncture wound.   The outcome of the events was unknown.  The reporter assessed the event of 'illness' as serious due to seriousness criteria of life-threatening and not related to RabaVert.   Additional information was received from Agency on 14-Jul-2021 included confirmation of the country of occurrence.  No further information was provided.; Reporter's Comments: Illness is not listed for RabAvert according to the SmPC and Prescriber Information. Product administration error, inappropriate schedule of product administration and product dose omission issue are listed by convention. Reportedly, the patient had completed the Rabies vaccine series 10 years ago. On 01-Jun-2021, the patient had exposure, and received the first vaccine dose seven days after the exposure, which is considered as inappropriate schedule of product administration. After three days the patient received co-suspect vaccine HRIG as second dose, which is considered as product administration error and product dose omission issue. Patient's medical history included immunocompromised health, unspecified disability and puncture wound. Patient received first dose of the vaccine eight days after puncture wound, therefore there is no temporal relationship between event illness and suspect vaccine (event is not related to suspect). Reported events product administration error, inappropriate schedule of product administration and product dose omission issue are not related to the suspect product but to a human action.; Sender's Comments: Illness is not listed for RabAvert according to the SmPC and Prescriber Information. Product administration error, inappropriate schedule of product administration and product dose omission issue are listed by convention. Reportedly, the patient had completed the Rabies vaccine series 10 years ago. On 01-Jun-2021, the patient had exposure, and received the first vaccine dose seven days after the exposure, which is considered as inappropriate schedule of product administration. After three days the patient received co-suspect vaccine HRIG as second dose, which is considered as product administration error and product dose omission issue. Patient's medical history included immunocompromised health, unspecified disability and puncture wound. Patient received first dose of the vaccine eight days after puncture wound, therefore there is no temporal relationship between event illness and suspect vaccine (event is not related to suspect). Reported events product administration error, inappropriate schedule of product administration and product dose omission issue are not related to the suspect product but to a human action.