Sex: F
Vaccine: RAB
Symptoms: Arthralgia, Chills, Fatigue, Feeling cold, Inappropriate schedule of product administration
Clinical narrative: The patient was bitten by an unvaccinated cat on her hand and went to the ER on 6-Jun-2022 to receive post-exposure prophylaxis for rabies. Nine hours later, on 7-Jun-2022, patient received her first dose of Rabavert; The patient's joints also were hurting around her hand where she was bitten and doctor suspected it might be an infection from the cat bite; chills, goose bumps all over her body, and she felt like she "had been hit by a Mack Truck"; chills, goose bumps all over her body, and she felt like she "had been hit by a Mack Truck"; The patient was cold all over (not blue) and her extremities felt like they had been frozen; The patient was cold all over (not blue) and her extremities felt like they had been frozen; The patient experienced fatigue around this time and was very tired, missing phone calls because she slept through them which does not typically happen; chills, goose bumps all over her body, and she felt like she "had been hit by a Mack Truck"; The patient experienced fatigue around this time and was very tired, missing phone calls because she slept through them which does not typically happen; The patient's joints also were hurting around her hand where she was bitten; Case reference number US-BN-2022-001259 is a spontaneous case report initially received on 10-Jun-2022 with reference number: (USBAV22-0300) and concerns a 64-years-old female patient.  The patient's medical history included unusual reactions with other medications and immunisations in the past and an allergy to lidocaine, the chemical and ethyl oxide.  The patient's concomitant medication details were not provided.  On 06-Jun-2022, the patient was bitten by an unvaccinated cat on hand and went to the emergency room to receive post-exposure prophylaxis for rabies.  On 07-Jun-2022, nine hours later as reported, the patient received first dose of Rabavert (lnactivated rabies virus vaccine; batch number: YRBA821A, expiration date:  Feb-2024) at dose of 1 mL intramuscularly for post-exposure rabies prophylaxis (explicitly coded as Inappropriate schedule of vaccine administered').   On 08-Jun-2022, around 10 am as reported, the patient experienced chills, goose bumps all over the body, and felt like "had been hit by a Mack Truck". Additionally, the patient experienced cold all over (not blue) and extremities felt like they had been frozen, despite wearing socks on feet. The patient checked temperature several times during this episode and it was around 97.7 F. Also experienced fatigue around this time and was very tired, missing phone calls because slept through them which did not typically happen, the patient's joints also were hurting around hand where the patient was bitten. The patient's doctor suspected it might be an infection from the cat bite and prescribed treatment with Augmentin for it.   On 09-Jun-2022, the patient was recovered from all events.  On 10-Jun-2022, the patient received the second dose of Rabavert (batch number: YRBA831, expiration date: Feb-2024) at dose od 1 mL intramuscularly. The patient also took 1000 mg of Tylenol (paracetamol) around the time of second dose, which the patient did not do with the first dose and had not experienced any issues so far.  The reporter assessed the events of Infection; Goose bumps; Abnormal physical sensation; Feeling cold; Cold extremities; Sleeplessness; Chills; Tiredness; Joint pain as non serious and possibly related to Rabavert vaccine.  Additional information received from Bavarian Nordic on 13-Jun-2022 included local case ID.; Reporter's Comments: A 64-years-old female patient was bitten by an unvaccinated cat on hand and went to the emergency room to receive post-exposure prophylaxis for rabies. Nine hours later as reported, the patient received first dose of Rabavert for post-exposure rabies prophylaxis, which is considered as inappropriate schedule of vaccine administered. One day later patient experienced chills, arthralgia, fatigue, insomnia, peripheral coldness, feeling cold, sensory disturbance, piloerection and infection. The patient's doctor suspected it might be an infection from the cat bite and prescribed treatment with Augmentin for it. Chills, arthralgia and fatigue are listed, whilst insomnia, peripheral coldness, feeling cold, sensory disturbance, piloerection and infection are unlisted for Rabipur according to datasheet. The patient's medical history included unusual reactions with other medications and immunisations in the past and an allergy to lidocaine, the chemical and ethyl oxide. The patient's concomitant medication details were not provided. Having in mind that cat bite and consequent infection around the site more logically explains all reported events, the causality is assessed as not related to Rabavert. Inappropriate schedule of vaccine administered is not related to RabAvert, but to a human factor. The case is non-serious.; Sender's Comments: A 64-years-old female patient was bitten by an unvaccinated cat on hand and went to the emergency room to receive post-exposure prophylaxis for rabies. Nine hours later as reported, the patient received first dose of Rabavert for post-exposure rabies prophylaxis, which is considered as inappropriate schedule of vaccine administered. One day later patient experienced chills, arthralgia, fatigue, insomnia, peripheral coldness, feeling cold, sensory disturbance, piloerection and infection. The patient's doctor suspected it might be an infection from the cat bite and prescribed treatment with Augmentin for it. Chills, arthralgia and fatigue are listed, whilst insomnia, peripheral coldness, feeling cold, sensory disturbance, piloerection and infection are unlisted for Rabipur according to datasheet. The patient's medical history included unusual reactions with other medications and immunisations in the past and an allergy to lidocaine, the chemical and ethyl oxide. The patient's concomitant medication details were not provided. Having in mind that cat bite and consequent infection around the site more logically explains all reported events, the causality is assessed as not related to Rabavert. Inappropriate schedule of vaccine administered is not related to RabAvert, but to a human factor. The case is non-serious.