Received Apr 7, 2026
| Type | Name | Manufacturer | Dose | Lot | Route / Site |
|---|---|---|---|---|---|
| RAB | RABIES (IMOVAX) | SANOFI PASTEUR | UNK | — | — |
it was freeze-dried and kept cold. she was given the third dose to bring back to u.s. but it had to be refrigerated. she had a stop-over in another country so she can't refrigerate and it had to be discarded since it got warm with no ae; also mentioned that it was reconstituted with normal saline with no ae; Initial information received on 15-Mar-2026 regarding an unsolicited valid non-serious case received from a pharmacist. This case involves a 56 years old female patient who had given the third dose of RABIES (HDC) VACCINE (IMOVAX RABIES) to bring back to her home country but it had to be refrigerated, she had a stop-over in another country so she could not refrigerate and it had to be discarded since it got warm with no adverse event (AE) and it was reconstituted with normal saline with no AE. The patient's past medical history, medical treatment(s), vaccination(s), family history were not provided. On an unknown date, the patient received 2 doses of RABIES (HDC) VACCINE [IMOVAX RABIES] powder and solvent for suspension for injection (batch/expiry: unknown) (strength: unknown) via unknown route in an unknown administration site for immunization (Immunisation). The patient was a pharmacist and she was also the patient. She was on an international trip and she just got back on Friday night. While she was travelling, she got attacked by a wild monkey. She ended up getting 2 doses of a rabies vaccine there a week ago. Because it had been a week, she was due for her third dose. She located another shot because she was a pharmacist, but the price was not something her insurance could cover. The price was ridiculous because it was $500 and she could not afford it. She also stated that she tried at the website and looking for other coupons and there was no assistance. SShe did not know if there was any assistance for her but she knew that she may have to get another dose totaling to 2 doses. She said that she was told before that she just needed 3 doses but when she came back, her doctor told her she may need 4. She reiterated that she needed her dose because that day was the 7th day. She got it the first day she got attacked then another shot in 48 hours. She asked if there were any provisions for her to discount the vaccine. She mentioned she had located an IMOVAX stock in one of their branches. She did not know the specific vaccine she received; she wished she took a photo but did not. She mentioned that a physician visited her and administered the vaccine. It was freeze-dried and kept cold, she was given the third dose to bring back but it had to be refrigerated, she had a stop-over in another country so she could not refrigerate and it had to be discarded since it got warm (Product storage error, onset: unknown, latency: unknown). She also mentioned that it was reconstituted with normal saline (Product preparation error, onset: unknown, latency: unknown). When asked if she was prescribed with IMOVAX, she said that her physician did not exactly say IMOVAX but to check whatever was available. Since her pharmacy had IMOVAX, she was given the prescription for it. Action taken: not applicable. This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holder's compliance with the requirements set out in the Directive 2001/83/EC and Module VI of the Good Pharmacovigilance Practices. The classification as a medical error is in no way intended, nor should it be interpreted or construed as an allegation or claim made by the marketing authorization holder that any third party has contributed to or is to be held liable for the occurrence of this medication error.
Comments: NONE