Sex: M
Vaccine: RAB, TTOX
Symptoms: Anxiety, Salivary hypersecretion
Clinical narrative: Anxiety; worried; Slight excessive salivation; Case reference number US-BN-2022-001831 is a spontaneous case report initially received on 08-Aug-2022 from a consumer (reference number: USBAV22-0870) and concerns a male patient.  The patient's medical history and concomitant medication details were not reported.  On 14-Jul-2022, the patient was vaccinated with the first dose of RabAvert (Rabies Virus (Inactivated, Strain Flury LEP), batch number: unknown), at an unknown dose or route of administration, for post-exposure.   On unspecified dates, the patient was vaccinated with co-suspect tetanus (brand name unknown) and received co-suspect human rabies immune globulin (HRIG), both at an unknown dose or route of administration, for unknown indication.  On 17-Jul-2022, three days after the first dose, the patient was vaccinated with the second dose of RabAvert (batch number: unknown), at an unknown dose or route of administration.  On 21-Jul-2022, seven days after the first dose, the patient was vaccinated with the third dose of RabAvert (batch number: unknown), at an unknown dose or route of administration.  On an unspecified date in 2022, reported as right before the fourth dose, the patient had slight excessive salivation. The patient was not sure if that was due to anxiety, the patient had no other symptoms, and the slight excessive salivation continued well over a week.  On 28-Jul-2022, 14 days after the first dose, the patient was vaccinated with the fourth dose of RabAvert (batch number: unknown), at an unknown dose or route of administration.  On an unspecified date, reported as after the patient's fourth dose, slight excessive salivation began to get better. As reported, it was not drooling and it was not excessive.  As reported, the patient was worried because did not know if the shot made one immuno-compromised. The patient did not change the toothbrush or sheets right after exposure and getting vaccines, and asked whether to worry about re-exposure.  At the time of this report, the outcome of the event 'anxiety' was unknown.  The reporter did not provide causality and seriousness assessment for the events.  Additional information received from Bavarian Nordic on 09-Aug-2022 included local case ID.; Reporter's Comments: A male patient had slight excessive salivation, right before the fourth dose and he was not sure if that was due to anxiety as he had no other symptoms. Slight excessive salivation continued well over a week. 14 days after the first dose, the patient was vaccinated with the fourth dose of RabAvert, at an unknown dose or route of administration. After the patient's fourth dose, slight excessive salivation began to get better and reportedly it was not drooling and it was not excessive. The patient was vaccinated with the first dose of RabAvert at an unknown dose or route of administration, for post-exposure, second dose was administered three days after the first dose and seven days after the first dose third dose was administered. On unspecified dates, the patient was vaccinated with co-suspect tetanus  and received co-suspect human rabies immune globulin (HRIG), both at an unknown dose or route of administration, for unknown indication. Anxiety and salivary hypersecretion are both considered listed according to summary for RabAvert. The outcome of the event anxiety was unknown at this point. The patient's medical history and concomitant medication details were not reported. Causality is assessed as related for both anxiety and salivary hypersecretion due to plausible temporal relationship and since contributory role of the suspect product cannot be fully excluded at this point. The case is considered as non-serious.; Sender's Comments: A male patient had slight excessive salivation, right before the fourth dose and he was not sure if that was due to anxiety as he had no other symptoms. Slight excessive salivation continued well over a week. 14 days after the first dose, the patient was vaccinated with the fourth dose of RabAvert, at an unknown dose or route of administration. After the patient's fourth dose, slight excessive salivation began to get better and reportedly it was not drooling and it was not excessive. The patient was vaccinated with the first dose of RabAvert at an unknown dose or route of administration, for post-exposure, second dose was administered three days after the first dose and seven days after the first dose third dose was administered. On unspecified dates, the patient was vaccinated with co-suspect tetanus  and received co-suspect human rabies immune globulin (HRIG), both at an unknown dose or route of administration, for unknown indication. Anxiety and salivary hypersecretion are both considered listed according to summary for RabAvert. The outcome of the event anxiety was unknown at this point. The patient's medical history and concomitant medication details were not reported. Causality is assessed as related for both anxiety and salivary hypersecretion due to plausible temporal relationship and since contributory role of the suspect product cannot be fully excluded at this point. The case is considered as non-serious.