Received Jun 27, 2025
| Type | Name | Manufacturer | Dose | Lot | Route / Site |
|---|---|---|---|---|---|
| RAB | RABIES (RABAVERT) | NOVARTIS VACCINES AND DIAGNOSTICS | 4 | Unknown | IM / LA |
The patient had quick pressure in head, was harder on the left and inside of the skull; Insomnia; Nervous; Nerve shooting and prickling; The patient felt heart racing; Sporadic tingling; Headache; Nausea; Patient had symptoms after his first shot od Rabavert; The patient received third dose of Rabavert eight days after first dose; The patient drunk alcohol after administrated Rabavert; The first shot that was given to patient was actually three shots: 1 in the left arm and two in the buttocks along with the immunoglobulins; The first shot that was given to patient was actually three shots: 1 in the left arm and two in the buttocks along with the immunoglobulins; The patient received second dose of RabAvert in buttocks; Case reference number US-BN-2024-001939 is a spontaneous case report initially received from a consumer via Med Communications (reference number USBAV24-1106) on 22-May-2024 and concerns an adult female patient of unspecified age. The patient's medical history and concomitant medication details were not provided. On an unspecified date, the patient was bitten by batt. On 04-May-2024, unknown amount of time after bat bite, the patient received the first dose of RabAvert (batch number: unknown), at an unknown dose, in left arm, intramuscularly, for postexposure prophylaxis. As reported, the first shot that was given to the patient was actually three shots: one in the left arm and two in the buttocks along with the co-suspect immunoglobulins (brand name: unknown), at an unknown dose (explicitly coded as 'Product administration error', 'Lack of vaccination site rotation', 'Overdose', 'Vaccine administered at inappropriate site'). On an unspecified date, as reported, after first shot the patient had symptoms. On 07-May-2024, three days after first dose of RabAvert, unknown amount of time after bat bite, the patient received the second dose of RabAvert (batch number: unknown), intramuscularly, at an unknown dose, and route of administration. On 12-May-2024, eight days after first dose of RabAvert, unknown amount of time after bat bite, the patient received the third dose of RabAvert (batch number: unknown), intramuscularly, at an unknown dose, and route of administration (explicitly coded as 'Inappropriate schedule of vaccine administered'). On 18-May-2024, 14 days after first dose of RabAvert, unknown amount of time after bat bite, the patient received the fourth dose of RabAvert (batch number: unknown), intramuscularly, at an unknown dose, and route of administration. On an unspecified date, as reported the patient had been lying down going to sleep, try to go to sleep and feeling heart racing, sporadic tingling, nerve shooting and prickling, headache, a quick pressure in head, was harder on the left and inside of the skull, nausea, but it was not bad, no vomiting and obviously insomnia. As reported, the patient was nervous since was bitten by the bat and maybe the patient drunk a little bit too much of alcohol (explicitly coded as 'Product administration error'). At the time of initial report, it was unknown if the patient recovered from the events of 'heart racing', 'tingling', 'neuralgia', 'nervous', 'headache', 'head pressure', 'nausea', 'insomnia' and 'adverse event NOS'. The reporter assessed events of 'heart racing', 'tingling', 'neuralgia', 'nervous', 'headache', 'head pressure', 'nausea', 'insomnia' as non-serious and possibly related to RabAvert. The reporter did not provide seriousness and causality assessment for event of 'adverse event NOS'. No further information was provided.; Reporter's Comments: An adult female patient of unspecified age received the first dose of RabAvert, an unknown amount of time after the bat bite, in left arm, intramuscularly, for postexposure prophylaxis. As reported, the first shot that was given to the patient was actually three shots: one in the left arm and two in the buttocks along with the co-suspect immunoglobulins, which is considered as product administration error, lack of vaccination site rotation, overdose and vaccine administered at inappropriate site. Reportedly, on the days 8 and 14 after the first dose, the patient received the third and the fourth dose of RabAvert, which is considered as inappropriate schedule of vaccine administered. On an unspecified date, the patient had been lying down going to sleep, try to go to sleep and feeling heart racing, sporadic tingling, nerve shooting and prickling, headache, a quick pressure in head, was harder on the left and inside of the skull, nausea, but it was not bad, no vomiting and obviously insomnia. As reported, the patient was nervous since was bitten by the bat and maybe the patient drunk a little bit too much of alcohol, which is considered as product administration error. Paraesthesia, headache and nausea are listed and expected for RabAvert, whilst head discomfort, insomnia, nervousness and neuralgia are unlisted and unexpected. Palpitations is unlisted per authority 1 and expected per authority 2. Product administration error, lack of vaccination site rotation, overdose, product administration error, adverse event and vaccine administered at inappropriate site are considered as listed per company convention. The patient's medical history and concomitant medication details were not provided. The outcome was unknown. Considering implied temporal relationship and since the contributory role of the suspect vaccine cannot be excluded with certainty, the reported events have been considered as related to RabAvert. Product administration error, lack of vaccination site rotation, overdose, product administration error and vaccine administered at inappropriate site have been considered as not related to the suspect vaccine, but to a human factor. This case is considered as non-serious.; Sender's Comments: An adult female patient of unspecified age received the first dose of RabAvert, an unknown amount of time after the bat bite, in left arm, intramuscularly, for postexposure prophylaxis. As reported, the first shot that was given to the patient was actually three shots: one in the left arm and two in the buttocks along with the co-suspect immunoglobulins, which is considered as product administration error, lack of vaccination site rotation, overdose and vaccine administered at inappropriate site. Reportedly, on the days 8 and 14 after the first dose, the patient received the third and the fourth dose of RabAvert, which is considered as inappropriate schedule of vaccine administered. On an unspecified date, the patient had been lying down going to sleep, try to go to sleep and feeling heart racing, sporadic tingling, nerve shooting and prickling, headache, a quick pressure in head, was harder on the left and inside of the skull, nausea, but it was not bad, no vomiting and obviously insomnia. As reported, the patient was nervous since was bitten by the bat and maybe the patient drunk a little bit too much of alcohol, which is considered as product administration error. Paraesthesia, headache and nausea are listed and expected for RabAvert, whilst head discomfort, insomnia, nervousness and neuralgia are unlisted and unexpected. Palpitations is unlisted per authority 1 and expected per authority 2. Product administration error, lack of vaccination site rotation, overdose, product administration error, adverse event and vaccine administered at inappropriate site are considered as listed per company convention. The patient's medical history and concomitant medication details were not provided. The outcome was unknown. Considering implied temporal relationship and since the contributory role of the suspect vaccine cannot be excluded with certainty, the reported events have been considered as related to RabAvert. Product administration error, lack of vaccination site rotation, overdose, product administration error and vaccine administered at inappropriate site have been considered as not related to the suspect vaccine, but to a human factor. This case is considered as non-serious.
Comments: None
Immunoglobulins