Received Jun 27, 2025
| Type | Name | Manufacturer | Dose | Lot | Route / Site |
|---|---|---|---|---|---|
| RAB | RABIES (RABAVERT) | NOVARTIS VACCINES AND DIAGNOSTICS | 4 | Unknown | — |
The patient received too high RabAvert vaccine, injected either into the shoulder joint or subacromial bursa; The patient had limited mobility and range of motion in shoulder joint and persistent pain; The patient had limited mobility and range of motion in shoulder joint and persistent pain; Case reference number US-BN-2024-002376 is a spontaneous case initially received from consumer via Med Communications (reference number USBAV24-2062) on 21-Aug-2024 and concerns a *24-years-old* female patient. The patient's medical history and concomitant medication details were not provided. On an unspecified date, the patient received HRIG (immunoglobulin human anti-rabies; batch number: unknown), at an unknown dose, route or site of administration for post exposure prophylaxis. On unspecified dates, reported as on day zero, three and seven the patient received three doses of RabAvert (batch number: unknown), at an unknown dose, route or site of administration for post exposure prophylaxis. On 06-Aug-2024, on day 14, the patient received the fourth dose of RabAvert *(batch number: FDP00543; expiration date: Sep-2027 ), at dose of 1 ml, intramuscularly*, at unknown site of administration which was also reported as too high, and patient believed that it was injected either into the shoulder joint or subacromial bursa (explicitly coded as 'vaccine administered at inappropriate site'). *On 08-Jun-2024 at 07:48 *, as reported in the past two weeks since receiving the injection, *immediately after vaccination* the patient had *severe* limited mobility and range of motion in shoulder joint and persistent pain. * On unspecified date, the patient had four views for left shoulder, due to clinical history left shoulder pain and stiffness; technique: the left shoulder was examined in the internal rotation, external rotation, axillary, and trans scapular Y projections, comparison: none, findings: there is no fracture, subluxation, or dislocation, the acromioclavicular and glenohumeral joints appear grossly intact, the bony mineralization is within normal limits, there was not radiopaque foreign body seen, impression: no evidence of acutely displaced fracture or dislocation of the left shoulder. * *At the time of follow up report, the patient did not recover from events of 'mobility decreased' and 'joint pain'.* The reporter assessed the events of 'mobility decreased' and 'joint pain' as non-serious and possibly related to RabAvert. All follow-up information is blended into the case narrative above, with the latest information presented between asterisks (*). Follow up report received from consumer on 17-Sep-2024 new information include: dosing information for fourth dose of RabAvert, volume, route of administration, batch number and expiration date, patient age, severity, start date and outcome for events of 'mobility decreased' and 'joint pain', and results of performed investigation. Additional information received from consumer via Med Communications on 17-Sep-2024 included additional reference number USBAV24-2395.; Reporter's Comments: A 24-years-old female patient received the fourth dose of RabAvert, at dose of 1 ml, intramuscularly, for post exposure prophylaxis. Reportedly, the patient believed that it was injected either into the shoulder joint or subacromial bursa, which is considered as vaccine administered at inappropriate site. Two days after the fourth dose of RabAvert was administered, also reported as in the past two weeks since receiving the injection, the patient had severe limited mobility and range of motion in shoulder joint and persistent pain. Arthralgia is listed and expected for RabAvert, whilst mobility decreased is unlisted and unexpected. Product administered at inappropriate site is considered as listed per company convention. The patient's medical history and concomitant medication details were not provided. The outcome was not resolved. Considering plausible temporal relationship and since the contributory role of the suspect vaccine cannot be excluded, the events of arthralgia and mobility decreased have been considered as related to RabAvert. Product administered at inappropriate site is not related to the suspect vaccine, but to a human factor. This case is considered as non-serious.; Sender's Comments: A 24-years-old female patient received the fourth dose of RabAvert, at dose of 1 ml, intramuscularly, for post exposure prophylaxis. Reportedly, the patient believed that it was injected either into the shoulder joint or subacromial bursa, which is considered as vaccine administered at inappropriate site. Two days after the fourth dose of RabAvert was administered, also reported as in the past two weeks since receiving the injection, the patient had severe limited mobility and range of motion in shoulder joint and persistent pain. Arthralgia is listed and expected for RabAvert, whilst mobility decreased is unlisted and unexpected. Product administered at inappropriate site is considered as listed per company convention. The patient's medical history and concomitant medication details were not provided. The outcome was not resolved. Considering plausible temporal relationship and since the contributory role of the suspect vaccine cannot be excluded, the events of arthralgia and mobility decreased have been considered as related to RabAvert. Product administered at inappropriate site is not related to the suspect vaccine, but to a human factor. This case is considered as non-serious.
Comments: None
HRIG