Received Jun 27, 2025
| Type | Name | Manufacturer | Dose | Lot | Route / Site |
|---|---|---|---|---|---|
| RAB | RABIES (RABAVERT) | NOVARTIS VACCINES AND DIAGNOSTICS | 2 | ARBB091B | IM / RA |
The vaccination with RabAvert interrupted due to event, the third vaccination was held as medical staff wanted to be sure that the patient was not have a side effect from vaccine; The patient experienced after second dose of RabAvert gripping and squeezing chest pain that came and went and sometimes radiated to shoulder; The patient experienced after second dose of RabAvert gripping and squeezing chest pain that came and went and sometimes radiated to shoulder; Case reference number US-BN-2024-002200 is a spontaneous case initially received from a nurse via Bavarian Nordic (reference number: BN_2024_02886) on 16-Jul-2024 and concerns a *28-year-old female* patient. The patient's medical history and concomitant medication were not provided. *On 14-Jun-2024, the patient was vaccinated with the first dose of RabAvert (batch number: ARBB091B) at dose of 1 mL, intramuscularly in right deltoid, for indication reported as the patient was animal care technician.* *On 21-Jun-2024, seven days after first dose of RabAvert, the patient was vaccinated with the second dose of RabAvert (batch number: ARBB091B) at dose of 1 mL, intramuscularly in right deltoid.* *On 22-Jul-2024, one day* after the second dose of RabAvert, the patient experienced *as reported gripping and squeezing chest pain that comes and goes and sometimes radiates to shoulder,* reported as patient believing to be a side effect of the RabAvert vaccine. *As reported the vaccination with RabAvert was interrupted due to events, as medical staff wanted to be sure that the patient was not having a side effect from the vaccine (explicitly coded as 'Inappropriate schedule of vaccine administered').* *At the time of the follow up report, the patient was recovering form events of 'chest pain' and 'shoulder pain', with events lasting for four weeks and as reported continuing.* *The reporter assessed the events of 'pain chest' and 'shoulder discomfort' as non-serious, mild in intensity* and possibly related to the RabAvert, also stated the patient believed it was side effect of the RabAvert vaccine. All follow-up information is blended into the case narrative above, with the latest information presented between asterisks (*). Follow up information received form nurse on 26-Jul-2024: New information included patient's demographic information, dosing information for first and second dose of RabAvert, added adverse events, start date, seriousness and causality assessment and interruption of vaccination due to which 'inappropriate schedule of vaccine administered' was coded.; Reporter's Comments: A 28-year-old female patient experienced the non-serious events of chest pain and shoulder pain (described as radiating pain that comes and goes), one day after receiving the second dose of RabAvert. The second dose of RabAvert was given on day 7 after the first one, which is considered inappropriate schedule of vaccine administered. Chest pain is unlisted and unlabeled, whereas arthralgia is listed and labeled for RabAvert. Inappropriate schedule of vaccination is considered listed per company convention. Patient was currently recovering. The patient's medical history and concomitant medication were not provided. The events are considered related due to the suggestive temporal relationship to the vaccine administration. The irradiating nature of the pain, which was resolving, is suggesting that the chest pain was also of musculoskeletal origin. Inappropriate schedule of vaccination is not related to RabAvert, but to human factors.; Sender's Comments: A 28-year-old female patient experienced the non-serious events of chest pain and shoulder pain (described as radiating pain that comes and goes), one day after receiving the second dose of RabAvert. The second dose of RabAvert was given on day 7 after the first one, which is considered inappropriate schedule of vaccine administered. Chest pain is unlisted and unlabeled, whereas arthralgia is listed and labeled for RabAvert. Inappropriate schedule of vaccination is considered listed per company convention. Patient was currently recovering. The patient's medical history and concomitant medication were not provided. The events are considered related due to the suggestive temporal relationship to the vaccine administration. The irradiating nature of the pain, which was resolving, is suggesting that the chest pain was also of musculoskeletal origin. Inappropriate schedule of vaccination is not related to RabAvert, but to human factors.
Comments: None