Age: 45.0
Sex: M
Vaccine: HEP, HPVX, HPVX, HPVX
Symptoms: Product use issue
Clinical narrative: male patient who received HPV vaccine; male patient received HPV vaccine; 45 year old male patient who received HPV vaccine; buttock became swollen and in pain/ his butt cheeks hurt so bad; Edema/buttock became swollen and in pain; he was having a hard time walking; sweats; patient was so ill; This non-serious case was reported by a consumer via call center representative and described the occurrence of buttock pain in a 45-year-old male patient who received cabotegravir, rilpivirine (Cabenuva) suspension for injection for drug use for unknown indication.   Co-suspect products included Hepatitis B vaccine for prophylaxis, HPV 16-18 (HPV vaccine) for prophylaxis, HPV 16-18 (HPV vaccine) for prophylaxis and HPV 16-18 (HPV vaccine) for prophylaxis.   Concurrent medical conditions included hiv infection.   On 27-SEP-2023, the patient started Cabenuva (intramuscular), the 3rd dose of Hepatitis B vaccine and the 3rd dose of HPV vaccine. On an unknown date, the patient received the 1st dose of HPV vaccine and the 2nd dose of HPV vaccine. In 2023, an unknown time after starting Cabenuva, an unknown time after receiving Hepatitis B vaccine and HPV vaccine and not applicable after receiving HPV vaccine and HPV vaccine, the patient experienced walking difficulty (Verbatim: he was having a hard time walking), sweating (Verbatim: sweats) and illness (Verbatim: patient was so ill). On 27-SEP-2023, the patient experienced buttock pain (Verbatim: buttock became swollen and in pain/ his butt cheeks hurt so bad), edema (Verbatim: Edema/buttock became swollen and in pain), product use in unapproved population (Verbatim: male patient received HPV vaccine) and inappropriate age at vaccine administration (Verbatim: 45 year old male patient who received HPV vaccine). On an unknown date, the patient experienced product use in unapproved population (Verbatim: male patient who received HPV vaccine). The action taken with Cabenuva was unknown. The outcome of the buttock pain, edema, walking difficulty, sweating and illness were not resolved and the outcome of the product use in unapproved population, inappropriate age at vaccine administration and product use in unapproved population were unknown.   It was unknown if the reporter considered the buttock pain, edema, walking difficulty, sweating and illness to be related to Cabenuva, Cabenuva Needle Device, Cabenuva Syringe Device, Cabenuva Vial Adaptor Device, Hepatitis B vaccine and HPV vaccine.     It was unknown if the company considered the buttock pain, edema, walking difficulty, sweating and illness to be related to Cabenuva, Cabenuva Needle Device, Cabenuva Syringe Device, Cabenuva Vial Adaptor Device, Hepatitis B vaccine and HPV vaccine.   This report made by GSK without prejudice and does not imply any admission or liability for the incident or its consequences.    GSK Receipt Date: 02 Oct 2023 and 02 Oct 2023 Reporter was a patient who received Cabenuva at a Department of Health Clinic. He reported that 5 hours after receiving his injections his left buttock became swollen and in pain. Reporter stated the pain was so bad he was having a hard time walking and he had to lay on his stomach. Patient was unsure of which portion of the medication was injected into the left gluteal. Consented to follow up. Site of injection was left gluteal. Patient reported that its been five days and each of his butt cheeks hurt so bad patient had the sweats and he had not able to get out of bed. They admin the Cuva with an HPV vaccine and hepatitis B vaccine if that means anything patient was so ill. Because the product was not complete, reporter called the customer and was provided with the following information as well. However, the call was disconnected and the customer called back immediately and spoke with a product representative. The shots were received last Wednesday. This was the second month round of Cabenuva. Customer did not have lot numbers for 3 any vaccines he had that day. He said he called the nurse at the county health department. Patient said symptoms have not resolved. He said he did not know the names of the Hep B and HPV vaccines, just that it was the last did in a 3 series. No other information was provided since the call disconnected.