Age: 65.0
Sex: F
Vaccine: FLU4, PPV, TDAP, VARZOS
Symptoms: Blood pressure decreased, Hypotension, Nausea, Pain, Vomiting
Clinical narrative: Low blood pressure; Debilitating pain; Nausea; Vomiting; Afluria Quadrivalent and Pneumovax were both administered in the right arm on the same day; This spontaneous case was retrieved on 29-Jul-2022 from Reporting System (reference number: 0881032-1), reported by other healthcare professional and concerned a 65-year-old, female patient.  The patient's concurrent conditions included Addison's disease, penicillin allergy and allergy to penothiazines and cephalosporins. The patient's concomitant medications were not reported.  On 24-Aug-20220, the patient was vaccinated with Afluria Quadrivalent (influenza vaccine inact split 4v; route of administration: intramuscular, anatomical location: right arm, dose and indication: not reported). The batch number reported was P100230202.  On the same date, the patient was also vaccinated with non company co-suspects Pneumovax (pneumococcal vaccine polysacch 23v; route of administration: intramuscular, anatomical location: right arm, batch number: S005857, dose and indication: not reported) (explicitly coded as 'Product administration error'), Boostrix (diphtheria vaccine toxoid, pertussis vaccine acellular 3-component, tetanus vaccine toxoid; route of administration: intramuscular, anatomical location: left arm, batch number: 49R79, dose and indication: not reported) and Shingrix (varicella zoster vaccine rge (cho); route of administration: intramuscular, anatomical location: left arm, batch number: 73E59, dose and indication: not reported).  On 25-Aug-2020, one day after receiving Afluria Quadrivalent, Pneumovax, Boostrix and Shingrix, the patient experienced severe nausea, vomiting and low blood pressure, and debilitating pain.  At the time of the initial reporting, the patient did not recover from the events.  The reporter did not provide a causality assessment.  The case was assessed as non-serious.  Company comment: A 65-year-old, female patient was vaccinated with Afluria Quadrivalent and non-company co-suspect Pneumovax, on the same day and in the same anatomical location: right arm (explicitly coded as 'product administration error'). The patient also received non-company co-suspects Boostrix and Shingrix vaccines on the same day as mentioned vaccines. The patient experienced nausea, vomiting, low blood pressure and pain one day after vaccination. Despite confounding by co-suspect vaccines, causal role of the suspect product cannot be excluded. Therefore, causality for the reported events is assessed as possibly related due to plausible temporal relationship. Product administration error is assessed as unrelated per company's conventions.; Sender's Comments: A 65-year-old, female patient was vaccinated with Afluria Quadrivalent and non-company co-suspect Pneumovax, on the same day and in the same anatomical location: right arm (explicitly coded as 'product administration error'). The patient also received non-company co-suspects Boostrix and Shingrix vaccines on the same day as mentioned vaccines. The patient experienced nausea, vomiting, low blood pressure and pain one day after vaccination. Despite confounding by co-suspect vaccines, causal role of the suspect product cannot be excluded. Therefore, causality for the reported events is assessed as possibly related due to plausible temporal relationship. Product administration error is assessed as unrelated per company's conventions.