Age: 72.0
Sex: F
Vaccine: FLUA4, TDAP, VARZOS
Symptoms: Nausea, Presyncope, Product administration error, Tremor
Clinical narrative: Started to fade out of consciousness; Turned very red; Hand tremor; Dizziness; Clammy/Sweating; Vagal response; Nausea; Fluad Quadrivalent and Shingrix were administered on the same day, in the same right arm; This spontaneous case was retrieved on 18-Oct-2021 from Vaccine Adverse Event Reporting System (reference number: 1714882-1), reported by other health professional and concerned a 72-year-old, female patient.  The patient's concurrent conditions included allergy to sulphonamides, codeine, cortisone, amoxicillin and meloxicam. The patient's concomitant medications were not reported.   On 19-Sep-2021, the patient was vaccinated with Fluad Quadrivalent (influenza vaccine, inactivated influenza virus surface antigen (subunit), egg-derived, mf59; anatomical location: right arm, route of administration: intramuscular, dose reported as one and indication: not reported). The batch number reported was 312831.  On the same day, the patient was vaccinated with non-company, co-suspect vaccine Boostrix (diphtheria vaccine toxoid, pertussis vaccine acellular 3-component, tetanus vaccine toxoid; anatomical location: left arm, route of administration: intramuscular, dose reported as one and indication: not reported). The batch number reported was 57GJ2.  On the same day, the patient was vaccinated with another non-company, co-suspect Shingrix (varicella zoster vaccine rgE (CHO); anatomical location: right arm, route of administration: intramuscular, dose reported as one and indication: not reported) (explicitly coded as 'Product administration error'). The batch number reported was BM27F.  On the same day, after receiving Fluad Quadrivalent, Boostrix and Shingrix, the patient experienced a vagal response - turned very red, experienced hand tremor, nausea, dizziness, was clammy/sweating and started to fade out of consciousness. The reporter had the patient lie down and elevate her feet. She started to feel better and eventually sat up. She was given water and observed until she said that she felt fine. Total event was about 30 minutes.  On the same day, the patient recovered from all the events.   The reporter did not provide causality assessment.  The event of 'consciousness decreased' was considered to be medically significant by a Physician within Pharmacovigilance and Risk Management Department.  Company comment: A 72-year-old, female patient was vaccinated with the suspect product Fluad Quadrivalent and non-company, co-suspect Boostrix and Shingrix vaccines. Fluad Quadrivalent and Shingrix vaccines had been administered in the same arm (explicitly coded as 'Product administration error'). On the same day after vaccination the patient experienced a vagal response - turned very red, experienced hand tremor, nausea, dizziness, was clammy/sweating and started to fade out of consciousness. Information regarding the concomitant medications has not been provided. Causality for product administration error is assessed as not related as per company specific guidelines. Causality for all other events is assessed as possibly related, although confounded by concurrent administration of co-suspect vaccines.; Sender's Comments: A 72-year-old, female patient was vaccinated with the suspect product Fluad Quadrivalent and non-company, co-suspect Boostrix and Shingrix vaccines. Fluad Quadrivalent and Shingrix vaccines had been administered in the same arm (explicitly coded as 'Product administration error'). On the same day after vaccination the patient experienced a vagal response - turned very red, experienced hand tremor, nausea, dizziness, was clammy/sweating and started to fade out of consciousness. Information regarding the concomitant medications has not been provided. Causality for product administration error is assessed as not related as per company specific guidelines. Causality for all other events is assessed as possibly related, although confounded by concurrent administration of co-suspect vaccines.