Sex: F
Vaccine: RAB, UNK, UNK
Symptoms: Peripheral swelling, Product dose omission issue, Pyrexia
Clinical narrative: Lymphocytes were low; Racoon bite; Arm got swollen; The patient was knocked off; Headache; Fever; The second dose of RabAvert was administered six days after the first dose and the third dose was administered 16 days after the first dose; The patient received Imovax and RabAvert within the same immunization series; A fifth postexposure vaccine dose was not reported; Case reference number US-BN-2022-003175 is a spontaneous case report initially received on 22-Sep-2022 from a consumer via Communications (reference number: USBAV22-1505) and concerns a 35-year-old female patient.  The patient's medical history was not provided.  The patient's concomitant medications included Benadryl (diphenhydramine), antiallergy medicine (as reported, brand name unknown), nasal spray (as reported, brand name unknown) and corticosteroids (as reported, brand name unknown).  On an unspecified date, the patient was bitten by a racoon.  On 20-Aug-2022, the patient was vaccinated with the first dose of Imovax (rabies vaccine) and immunoglobulin (as reported, brand name unknown) both at an unknown dose, route or site of administration, for post-exposure rabies immunization. It was reported that the patient had no side effects after this dose.  On 23-Aug-2022, the patient was vaccinated with the first dose of RabAvert (rabies virus (inactivated, strain flury LEP) (PCEC); batch number: unknown) at an unknown dose, route or site of administration, for post-exposure rabies immunization (explicitly coded as 'interchange of vaccine products'). It was reported that the patient had no side effects after this dose.  On 29-Aug-2022, six days after the first dose, the patient was vaccinated with the second dose of RabAvert (batch number: unknown), at an unknown dose, route or site of administration (explicitly coded as 'inappropriate schedule of vaccine administered').  On an unspecified date, reported also as after the third dose (after the second RabAvert dose), an unknown amount of time after the vaccination, the patient was knocked off and experienced a low-grade headache.  On 08-Sep-2022, 16 days after the first dose, the patient was vaccinated with the third dose of RabAvert (batch number: unknown), at an unknown dose, route or site of administration (explicitly coded as 'inappropriate schedule of vaccine administered').  On an unspecified date, reported also as after the fourth dose (after the third RabAvert dose), an unknown amount of time after the vaccination, the patient developed fever and the patient's arm got swollen.  On an unspecified date, the patient's lymphocytes were low.  On an unspecified date, reported as two days ago, the patient was bitten by a racoon on left hand.  At the time of this report, it was unknown if the patient received a fifth postexposure dose (explicitly coded as 'product dose omission issue').  At the time of this report, outcome of the event 'lymphocytes were low' was unknown. On unspecified dates, the patient recovered from the other events.  The reporter assessed all events as non-serious and possibly related to the product.  Additional information received on 23-Sep-2022 included the local case ID.; Reporter's Comments: A 35-year-old female patient was bitten by a racoon. As postexposure prophylaxis, the patient received one dose of co-suspect vaccine Imovex Rabies, together with co-suspect product antirabies immunoglobulin, applied at an unknown dose, route or site of administration. On day 3 following the first vaccination, the patient received a dose of RabAvert, applied at an unknown dose, route or site of administration (which is considered interchange of vaccine products). The patient experienced no adverse events following the first two vaccines. On day 9 (which is considered inappropriate schedule of product administration), the patient received a second dose of RabAvert. The patient experienced the non-serious events of malaise and headache. On day 19 (which is also considered inappropriate schedule of product administration), the patient received a third dose of RabAvert (which was the fourth postexposure antirabies vaccination). After that, the patient experienced the non-serious events of fever and arm swelling (peripheral swelling). In addition, the patient reported having lymphocyte count reduced (onset date unknown, non-serious event). On an unknown date, reported as 'two days ago', the patient experienced the non-serious event of racoon bite. The current report was given on day 33 from the first postexposure vaccination. Considering that no fifth vaccine was reported for day 28 or any day, whereas the recommended regimen includes five vaccines, this is explicitly coded as product dose omission issue. Lymphocyte count reduced and racoon bite are unlisted, whereas malaise, headache and fever are listed per the guidelines for RabAvert. Peripheral swelling is listed per guidelines. Inappropriate schedule of product administration, interchange of vaccine products and product dose omission issue are considered listed per company convention. The patient's medical history was unknown. Concomitant medications included corticosteroids, diphenhydramine and other antiallergic products. Considering that corticosteroid therapy inhibits lymphocyte migration into lymph nodes and disrupts lymphocyte recirculation, the event of lymphocyte count decreased is assessed as not related to RabAvert. According to the guidelines, immunosuppressive agents should not be administered during postexposure therapy unless essential for the treatment of other conditions, as they may diminish immunity against rabies. Based on the accidental and/or occupational nature of the event of racoon bite, it is assessed as not related to RabAvert. Due to the suggestive temporal relationship, as well as the known safety profile, the events of peripheral swelling, malaise, headache and fever are assessed as related to RabAvert. Inappropriate schedule of product administration, interchange of vaccine products and product dose omission issue are considered not related to RabAvert, but to human error.; Sender's Comments: A 35-year-old female patient was bitten by a racoon. As postexposure prophylaxis, the patient received one dose of co-suspect vaccine Imovex Rabies, together with co-suspect product antirabies immunoglobulin, applied at an unknown dose, route or site of administration. On day 3 following the first vaccination, the patient received a dose of RabAvert, applied at an unknown dose, route or site of administration (which is considered interchange of vaccine products). The patient experienced no adverse events following the first two vaccines. On day 9 (which is considered inappropriate schedule of product administration), the patient received a second dose of RabAvert. The patient experienced the non-serious events of malaise and headache. On day 19 (which is also considered inappropriate schedule of product administration), the patient received a third dose of RabAvert (which was the fourth postexposure antirabies vaccination). After that, the patient experienced the non-serious events of fever and arm swelling (peripheral swelling). In addition, the patient reported having lymphocyte count reduced (onset date unknown, non-serious event). On an unknown date, reported as 'two days ago', the patient experienced the non-serious event of racoon bite. The current report was given on day 33 from the first postexposure vaccination. Considering that no fifth vaccine was reported for day 28 or any day, whereas the recommended regimen includes five vaccines, this is explicitly coded as product dose omission issue. Lymphocyte count reduced and racoon bite are unlisted, whereas malaise, headache and fever are listed per the guidelines for RabAvert. Peripheral swelling is listed per guidelines. Inappropriate schedule of product administration, interchange of vaccine products and product dose omission issue are considered listed per company convention. The patient's medical history was unknown. Concomitant medications included corticosteroids, diphenhydramine and other antiallergic products. Considering that corticosteroid therapy inhibits lymphocyte migration into lymph nodes and disrupts lymphocyte recirculation, the event of lymphocyte count decreased is assessed as not related to RabAvert. According to the guidelines, immunosuppressive agents should not be administered during postexposure therapy unless essential for the treatment of other conditions, as they may diminish immunity against rabies. Based on the accidental and/or occupational nature of the event of racoon bite, it is assessed as not related to RabAvert. Due to the suggestive temporal relationship, as well as the known safety profile, the events of peripheral swelling, malaise, headache and fever are assessed as related to RabAvert. Inappropriate schedule of product administration, interchange of vaccine products and product dose omission issue are considered not related to RabAvert, but to human error.