Age: 65.0
Sex: F
Vaccine: FLU4, PNC20, VARZOS, FLUA4, PNC20, VARZOS
Symptoms: Injection site cellulitis, Injection site erythema, Injection site swelling, Injection site warmth, Product administration error
Clinical narrative: Injection sites were red and spreading down her arm, hot and swollen like a red sunburn/ diagnosis was cellulitist; The patient received Fluad Quadrivalent and Pnemo vaccine on the same day, in the same arm; This spontaneous case was retrieved on 04-May-2022 from Vaccine Adverse Event Reporting System (VAERS) (reference number: 2244078-1), reported by other healthcare professional and concerned a 65-year-old, female patient.  The patient's concurrent conditions included epilepsy, hypothyroid, and high blood pressure. The patient had no known allergies. The patient's concomitant medications included Diovan (valsartan), valsartan (reported as 'valsart'), levothyroxine, levetiracetam (reported as 'levetiraceta'), extra strength magnesium, vitamins for hair, skin and nail with collagen, all used for an unreported indication.   On 15-Apr-2022,  the patient was vaccinated with non-company, co-suspect Prevnar 20 (pneumococcal vaccine conj 20v (crm 197); dose: reported as one, route of administration: intramuscular (IM), anatomical location: right arm (RA) and indication: not reported). The batch number reported was FJ2604.  On the same date, the patient was vaccinated with Fluad Quadrivalent (discrepant information reported as 'Afluria Quadrivalent') (influenza vaccine inact sag 4v; dose: reported as 'two', anatomical location: RA, route of administration, and indication: not reported) (explicitly coded as 'Product administration error'). The batch number reported was 312858.   On the same date, the patient was vaccinated with non-company, co-suspect Shingrix (varicella zoster vaccine rge (cho); dose: reported as 'one', anatomical location: left arm (LA), route of administration, and indication: not reported). The batch number reported was X2E93.   On 16-Apr-2022, one day after receiving Fluad Quadrivalent and non-company, co-suspects Prevnar 20 and Shingrix, the patient's injection sites were red and spreading down her arm, hot and swollen like a red sunburn. Her spouse recommend she see a doctor.   On 18-Apr-2022, the patient visited urgent care doctor who diagnosed her with cellulitis. Doctor recommended cold press, 500 mg cephalexin, 200 mg Motrin (ibuprofen) and ordered to returned if it had not cleared after four to five days.  At the time of initial reporting, the patient had not recovered from the event of 'cellulitis'.  The reporter did not provide causality assessment.  The event of 'cellulitis' was considered to be medically significant by a Physician within Seqirus' Pharmacovigilance and Risk Management Department.  Company comment: A 65-year-old female patient was vaccinated with Fluad Quadrivalent (right arm) and non-company co-suspect Prevnar 20 (right arm) and Shingrix (left arm) vaccines on the same date. Two vaccines were received in the same arm on the same day (explicitly coded as 'Product administration error'). Reportedly, the vaccination sites were erythematous, warm and swollen one day after. Three days after vaccinations, a diagnosis of cellulitis was made in both vaccination sites. Despite confounding by co-suspect Prevnar 20 vaccine, causal role of the suspect product cannot be excluded. Therefore, causality for cellulitis in right arm is assessed as possibly related. The reported events meet level 2 of  criteria for cellulitis at injection site. Causality for product administration error is assessed as not related as per company specific guidelines.; Sender's Comments: A 65-year-old female patient was vaccinated with Fluad Quadrivalent (right arm) and non-company co-suspect Prevnar 20 (right arm) and Shingrix (left arm) vaccines on the same date. Two vaccines were received in the same arm on the same day (explicitly coded as 'Product administration error'). Reportedly, the vaccination sites were erythematous, warm and swollen one day after. Three days after vaccinations, a diagnosis of cellulitis was made in both vaccination sites. Despite confounding by co-suspect Prevnar 20 vaccine, causal role of the suspect product cannot be excluded. Therefore, causality for cellulitis in right arm is assessed as possibly related. The reported events meet level 2 of criteria for cellulitis at injection site. Causality for product administration error is assessed as not related as per company specific guidelines.