Age: 65.0
Sex: F
Vaccine: FLUA4, PPV
Symptoms: Product administration error, Pyrexia
Clinical narrative: Swelling of right arm occurred with large bump/swelling kept spreading /arm was getting harder; Swelling of right arm occurred with large bump/swelling kept spreading /arm was getting harder; Swelling of right arm occurred with large bump/swelling kept spreading /arm was getting harder; Slight fever; Fatigue/exhaustion; Arm became sore/arm pain; Headache; Fluad Quadrivalent and Pneumovax were both given in left arm; Infection at the injection site; This spontaneous case was retrieved on 23-Dec-2020 from Vaccine Adverse Event Reporting System (VAERS) (reference number: 891626-1), reported by other health professional and concerned a 65-year-old, female patient.  The patient's procedure included lymph nodes removed under right arm. The patient's concomitant medications were not reported.  On 15-Oct-2020, on Thursday, the patient was vaccinated with Fluad Quadrivalent (influenza vaccine, inactivated influenza virus surface antigen (subunit), egg-derived, mf59, anatomical location: left arm, route of administration: intramuscular, dose: one as reported and indication: not reported) (explicitly coded as 'Product administration error'). The batch number reported was 279816.   On the same day, the patient was vaccinated with non-company co-suspect vaccine Pneumovax (pneumococcal vaccine polysacch 23v, dose: one as reported, route of administration: intramuscular, anatomical location: left arm and indication: not reported). The batch number reported was T010779.  On the same day, after receiving Fluad Quadrivalent and non-company co-suspect vaccine Pneumovax, the patient experienced severe headache.  On 16-Oct-2020, on Friday, one day after receiving Fluad Quadrivalent and non-company co-suspect vaccine Pneumovax, the patient experienced severe headache. The patient's arm became sore.  On 17-Oct-2020, on Saturday, two days after receiving Fluad Quadrivalent and non-company co-suspect vaccine Pneumovax, the patient experienced fatigue, slight fever, exhaustion, and headache.  On 18-Oct-2020, on Sunday morning, three days after receiving Fluad Quadrivalent and non-company co-suspect vaccine Pneumovax, the patient's headache went away. The patient developed swelling of right arm occurred with large bump and swelling kept spreading.   On 19-Oct-2020, on Monday, the patient visited doctor's office and he prescribed Keflex (cefalexin) at a dose of 500 mg four times a day and Benadryl (diphenhydramine hydrochloride).  On 20-Oct-2020, on Tuesday, six days after receiving Fluad Quadrivalent and non-company co-suspect vaccine Pneumovax, the patient's arm was getting harder and she experienced severe pain, and this continued 21-Oct-2020.  On 21-Oct-2020, on Wednesday, the patient returned to doctor's office and was given ceftriaxone intramuscularly and blood work was ordered. The patient had no infection in blood stream and was told to continue with Keflex (cefalexin) and ibuprofen.  On an unspecified date in Oct-2020, the patient had an infection at the injection site.  The outcome of the other events was unknown.  The reporter did not provide a causality assessment.   This case was assessed as non-serious.  Company comment: A 65-year-old patient was administered Fluad Quadrivalent. On the same day, the patient was vaccinated with non-company co-suspect vaccine Pneumovax. On the same day, after vaccination, the patient experienced headache. Two days later, the patient experienced fatigue, pyrexia, exhaustion, and headache. The patient developed swelling of right arm occurred with large bump and infection at the injection site. The patient had been treated with antibiotics. Causality is assessed as possibly related for all events. Per Brighton collaboration criteria, presented information correspond to level 2 diagnostic certainty for cellulitis at injection site. Fluad Quadrivalent and Pneumovax were both given in left arm. Product administration error is assessed as unrelated per company's conventions.; Sender's Comments: A 65-year-old patient was administered Fluad Quadrivalent. On the same day, the patient was vaccinated with non-company co-suspect vaccine Pneumovax. On the same day, after vaccination, the patient experienced headache. Two days later, the patient experienced fatigue, pyrexia, exhaustion, and headache. The patient developed swelling of right arm occurred with large bump and infection at the injection site. The patient had been treated with antibiotics. Causality is assessed as possibly related for all events. Per Brighton collaboration criteria, presented information correspond to level 2 diagnostic certainty for cellulitis at injection site. Fluad Quadrivalent and Pneumovax were both given in left arm. Product administration error is assessed as unrelated per company's conventions.