Age: 75.0
Sex: F
Vaccine: FLUA4
Symptoms: Condition aggravated, Feeling cold, Hypertension, Injection site swelling, Malaise
Clinical narrative: Blood pressure: 219/173, 186/97; Don't feel well- palpitation, cold and hurt around neck; Don't feel well- palpitation, cold and hurt around neck; Don't feel well- palpitation, cold and hurt around neck; Swelling 2r:1 inch right a way as the needle out; Don't feel well- palpitation, cold and hurt around neck; This spontaneous case was retrieved on 06-Jan-2021 from Vaccine Adverse Event Reporting System (VAERS) (reference number: 900434-1), reported by other health professional and concerned a 75-year-old female patient.  The patient's concurrent conditions included hypertension, hypercholesterolemia, osteoporosis. The patient's concomitant medications were not reported.  On 24-Oct-2020, the patient was vaccinated with Fluad Quadrivalent vaccine (influenza vaccine, inactivated influenza virus surface antigen (subunit), egg-derived, mf59; dose reported as one, route of administration: intramuscular, anatomical location: left arm and indication: not reported). The batch number reported was 279820.  On the same day, after receiving Fluad Quadrivalent, the patient developed swelling '2r' (as reported):1 inch, right away as the needle was out. After around 10 minutes, the patient did not feel well, had palpitation, was cold and hurt around the neck. Pharmacist gave two tablets of Benadryl (diphenhydramine hydrochloride) at dose of 25 mg by mouth. The blood pressure was monitored: 219/173 - 70 and five minutes after 186/97 - 70 (units were not reported). The patient asked to call 911. No further details were provided.   On an unspecified date in 2020, the patient recovered from all events.  The reporter did not provide a causality assessment.  The event of 'hypertension' was considered to be medically significant by a Physician within Seqirus' Pharmacovigilance and Risk Management Department.  Company comment: A 75-year-old patient was vaccinated with Fluad Quadrivalent. On the same day, after receiving Fluad Quadrivalent, the patient developed hypertension, palpitations, swelling, neck pain, malaise, vaccination site swelling and feeling cold. The patient's concurrent conditions included hypertension, hypercholesterolemia, osteoporosis. Causality was highly confounded for hypertension and palpitations, cannot be totally excluded due to plausible chronology. Causal role of the suspect vaccine is unassessable for hypertension and palpitations, due to lack of information regarding concomitant medications and treatment compliance. Causal role of the suspect vaccine is assessed as possibly related for swelling, neck pain, malaise, vaccination site swelling and feeling cold.; Sender's Comments: A 75-year-old patient was vaccinated with Fluad Quadrivalent. On the same day, after receiving Fluad Quadrivalent, the patient developed hypertension, palpitations, swelling, neck pain, malaise, vaccination site swelling and feeling cold. The patient's concurrent conditions included hypertension, hypercholesterolemia, osteoporosis. Causality was highly confounded for hypertension and palpitations, cannot be totally excluded due to plausible chronology. Causal role of the suspect vaccine is unassessable for hypertension and palpitations, due to lack of information regarding concomitant medications and treatment compliance. Causal role of the suspect vaccine is assessed as possibly related for swelling, neck pain, malaise, vaccination site swelling and feeling cold.