Age: 61.0
Sex: M
Vaccine: COVID19, FLUC3
Symptoms: Pruritus, Sleep disorder, Urticaria
Clinical narrative: Last two nights could not sleep; Hives started on ankles and proceeded up body; Hives itching; This spontaneous case was retrieved on 21-Oct-2021 from Vaccine Adverse Event Reporting System (VAERS) (reference number: 1759421-1), reported by other health professional and concerned a 61-year-old male patient.  The patient's current medical conditions included diabetes and asthma.  The patient's concomitant medication details included Medformin (Metformin hydrochloride) 1000mg, Simvastatin 20mg, Glipizide 5mg and Aspirin (Acetylsalicylic acid) 59mg, all for unknown indication.  On unspecified date, the patient was vaccinated with the first dose of non-company co-suspect Pfizer Covid-19 vaccine (Tozinameran; dose, route of administration, anatomical location and indication: not reported). The batch number was not reported.  On unspecified date, the patient was vaccinated with the second dose of non-company co-suspect Pfizer Covid-19 vaccine (Tozinameran; dose, route of administration, anatomical location and indication: not reported). The batch number was not reported.  On 24-Sep-2021, the patient was vaccinated with Flucelvax Quadrivalent vaccine (influenza vaccine, seasonal; dose: not reported, route of administration: intramuscular, anatomical location: arm and indication: not reported). The batch number was not reported.  On the same date, the patient was vaccinated with the third dose of non-company co-suspect Pfizer Covid-19 vaccine (Tozinameran; dose: not reported, route of administration: intramuscular, anatomical location: arm and indication: not reported). The batch number: FC3180.  On 30-Sep-2021, six days after receiving Flucelvax Quadrivalent vaccine, the patient developed hives on ankles which proceeded up to body and sleep disorder due to itching hives.  It was reported that the hives due to bugs were ruled out as the patient's partner who sleeps in the same bed did not have hives.   At the time of this report, outcomes of the events of sleep disorder, urticaria and pruritus were not resolved.  Causality assessment was not provided.  This case was assessed as non serious case.  Company comment: A 61-year-old male patient was vaccinated with Flucelvax Quadrivalent, first dose of non-company co-suspect Pfizer Covid-19 vaccine, second dose of non-company co-suspect Pfizer Covid-19 vaccine and third dose of non-company co-suspect Pfizer Covid-19 vaccine.  Six days following vaccination with Flucelvax Quadrivalent, the patient experienced urticaria, pruritus and sleep disorder. Causality is confounded by concurrent administration of co-suspect vaccine. The event of sleep disorder was due to urticaria and pruritus as reported, therefore not related to the vaccine. Causal role of the suspect vaccine is assessed as possibly related for other events, due to biological and chronological plausibility.; Sender's Comments: A 61-year-old male patient was vaccinated with Flucelvax Quadrivalent, first dose of non-company co-suspect Pfizer Covid-19 vaccine, second dose of non-company co-suspect Pfizer Covid-19 vaccine and third dose of non-company co-suspect Pfizer Covid-19 vaccine.  Six days following vaccination with Flucelvax Quadrivalent, the patient experienced urticaria, pruritus and sleep disorder. Causality is confounded by concurrent administration of co-suspect vaccine. The event of sleep disorder was due to urticaria and pruritus as reported, therefore not related to the vaccine. Causal role of the suspect vaccine is assessed as possibly related for other events, due to biological and chronological plausibility.