Sex: M
Vaccine: RAB
Symptoms: Insomnia, Paraesthesia, Poor quality sleep, Pruritus, Pyrexia
Clinical narrative: Unable to sleep well; feverish; significant sunburn on and around his lips despite sunscreen and after 2; Chills and shivering; He had tingling in both legs; He was shaking violently; He took his temperature and it was 94.5 F; He had some wrist tendonitis type symptoms; Itching; Burning in lower back; Fatigue; Case reference number BN-2021-002128 is a spontaneous case report initially received on 26-Jul-2021 from other health professional via Communication (reference number: USBAV21-0374) and concerns a 41-year-old male patient.   The patient did not have any relevant medical history. Concomitant medications were not reported.  On 23-Jul-2021, the patient was vaccinated with the first dose of RabAvert (Inactivated, Strain Flury LEP, batch number: ARBA801B) intramuscularly in the left deltoid at a dose of 1 millilitre, for possible bat exposure - post exposure immunization.   On 23-Jul-2021, an unknown amount of time after receiving the vaccine (reported as late), the patient had some itching, burning in his lower back and fatigue.   On 24-Jul-2021, the patient woke up round six a.m. shaking violently, his body temperature was 94.5 F. The patient drank fluids and after two hours his temperature was 97.6 F (normal).   On the same date, the patient had some wrist tendonitis type symptoms and had tingling in both legs.  On 26-Jul-2021 (approximately at 6 a.m.), the patient experienced chills and shivering. His body temperature was 97.2 F.   On the same day (by approximately 9 a.m.), the patient recovered from the event of chills.  Furthermore, on 26-Jul-2021, the patient recovered from the events of 'shaking' and 'body temperature decreased'.  On 30-Jul-2021, the patient was vaccinated with third dose of RabAvert (Inactivated, Strain Flury LEP, batch number: ARBA801B) at an unknown dose or route of administration, for possible bat exposure-post exposure immunization.   On 01-Aug-2021, the patient recovered from the events of  'itching', 'burning sensation', 'tingling' and 'tendonitis'.  On 02-Aug-2021, three days after the 3rd dose of RabaVert, the patient experienced significant sunburn on and around his lips despite sunscreen and after two hours of sun exposure.  On 06-Aug-2021, the patient was vaccinated with the fourth dose of RabAvert (Inactivated, Strain Flury LEP, batch number was not provided) at an unknown dose or route of administration, for possible bat exposure-post exposure immunization.   On 07-Aug-2021, the night after the fourth dose, the patient was feeling feverish. It was reported that the patient did not check his temperature that night, but stated he was sweating, unable to sleep well and knew [he] had a fever.  By the morning of 07-Aug-2021, the patient recovered from the event of 'fever'.  On 08-Aug-2021, the patient recovered from the event of 'fatigue' with no lasting side effects, as reported.  On 11-Aug-2021, the patient recovered from the event of 'sunburn'.  The reporter assessed all events as non-serious. The events of itching, burning in lower back, shaking, body temperature decreased, tendonitis, tingling, chills and fatigue were assessed as related to RabAvert. *The events sunburn and fever were assessed as highly probably related and the event insomnia was assessed as probably related to RabAvert*.   All follow up information are blended into the case narrative above, with the latest information presented between asterisks (*).  Follow up information received from healthcare professional on 20-Aug-2021: New information included: patient details (initials and date of birth), vaccination details (expiration date, confirmation of the Batch Number, two further doses), event details (onset dates, stop dates, outcomes, two new events).  Follow up information received from healthcare professional on 30-Aug-2021: New information included: seriousness and causality assessment for the events sunburn, fever and insomnia.; Reporter's Comments: Pruritus, burning sensation, tremor, body temperature decreased, tendonitis, insomnia and sunburn are not listed for RabAvert, while paraesthesia, chills, fatigue and pyrexia are listed per Prescriber Information. Reportedly, on the same day when vaccinated with first dose of suspect product for post-exposure prophylaxis, the patient experienced the events of pruritus, burning sensation, tremor, body temperature decreased, tendonitis, paraesthesia, chills and fatigue. Three days after the third dose, the patient experienced the event of sunburn, while the events of fever and insomnia occurred one day after the fourth dose. Patient recovered from all events without sequalae. Relevant medical history and concomitant medications were not reported. Since there were no other significant confounding factors for the events and temporal relationship is considered plausible, causality for the events of pruritus, burning sensation, tremor, body temperature decreased, tendonitis, paraesthesia, chills, fatigue, fever and insomnia is assessed as possibly related to the suspect product. The event of sunburn developed more likely because of sun exposure for two hours (as reported), and therefore causality for the event of sunburn is assessed as unlikely related.; Sender's Comments: Pruritus, burning sensation, tremor, body temperature decreased, tendonitis, insomnia and sunburn are not listed for RabAvert, while paraesthesia, chills, fatigue and pyrexia are listed per Prescriber Information. Reportedly, on the same day when vaccinated with first dose of suspect product for post-exposure prophylaxis, the patient experienced the events of pruritus, burning sensation, tremor, body temperature decreased, tendonitis, paraesthesia, chills and fatigue. Three days after the third dose, the patient experienced the event of sunburn, while the events of fever and insomnia occurred one day after the fourth dose. Patient recovered from all events without sequalae. Relevant medical history and concomitant medications were not reported. Since there were no other significant confounding factors for the events and temporal relationship is considered plausible, causality for the events of pruritus, burning sensation, tremor, body temperature decreased, tendonitis, paraesthesia, chills, fatigue, fever and insomnia is assessed as possibly related to the suspect product. The event of sunburn developed more likely because of sun exposure for two hours (as reported), and therefore causality for the event of sunburn is assessed as unlikely related.