Age: 61.0
Sex: F
Vaccine: UNK
Symptoms: Headache, Malaise, Nausea, Reaction to previous exposure to any vaccine, Vomiting
Clinical narrative: Blood was burning; Dizziness; Headache; Vomiting; Nausea; Malaise; Acute reaction to the vaccine; Dehydrated; The patient was vaccinated with Fluad Quad at the age of 61; This spontaneous case was received on 19-Oct-2020 from other non-health professional (consumer) via agency (reference number: SEQW20-03883) and concerned a 61-year-old female patient.  The patient's concurrent conditions included Diabetes and hypertension. The patient's concomitant medications included metformin, Lantus (insulin glargine), Bydureon (exenatide), losartan, paroxetine, montelukast, amlodipine, gabapentin, alprazolam, Alprazolam (levothyroxine sodium), trazodone, all for an unreported indication.  On 30-Sep-2019, the patient was vaccinated with Fluad Quadrivalent (influenza vaccine, inactivated influenza virus surface antigen (subunit), egg-derived, MF59; dose: 0.5 ml, route of administration: intramuscular and anatomical location: not reported] (explicitly coded as 'Inappropriate age at vaccine administration') for flu prevention. The batch number reported was UJ444AA and expiry date reported was 30-Jun-2021.  On 02-Oct-2020, two days after receiving Fluad Quadrivalent, the patient started feeling headache, vomiting, dizziness, nausea, malaise, the blood was burning but had no fever, shivering and flush.  On 05-Oct-2020, five days receiving Fluad Quadrivalent, the patient got the hospital and she found out she was dehydrated and having an acute reaction to the vaccine.  On an unspecified date in Oct-2020, the patient started treatment with Saline (sodium chlo-ride) via intravenous route of administration for rehydration at the dose of two bags.  At the time of initial report on 19-Oct-2020, the patient was recovering from the events as she stated she was better since 17-Oct-2020.  The reporter assessed the events as related to Fluad Quadrivalent. Consumer reported an adverse reaction to Fluad Quad. The patient found out she was having an acute reaction to the vaccine.  The reported assessed this case as non-serious.  Additional non-significant information received on 06-Nov-2020 from other non-health professional with additional document received on the same day (being processed together): The reporter's e-mail address and additional reference number were provided. No change in narrative.  Company comment: A 61-year-old, female patient was vaccinated with Fluad Quadrivalent vaccine. Two days after receiving vaccine, the patient developed headache, vomiting, dizziness, nausea, malaise, burning sensation (reported as "the blood was burning but had no fever, shivering and flush"). On 05-Oct-2020, five days receiving Fluad Quadrivalent, the patient got the hospital and she found out she was dehydrated and having an acute reaction to the vaccine. Chronology is compatible. The patient's concurrent conditions included Diabetes and hypertension. The patient's concomitant medications included metformin, Lantus (insulin glargine), Bydureon (exenatide), losartan, paroxetine, montelukast, amlodipine, gabapentin, alprazolam, Alprazolam (levothyroxine sodium), trazodone, all for an unreported indication. Causal role of suspect vaccine cannot be excluded and is assessed as possibly related for all events.; Reporter's Comments: Consumer reported an adverse reaction to Fluad Quad. The patient found out she was having an acute reaction to the vaccine.; Sender's Comments: A 61-year-old, female patient was vaccinated with Fluad Quadrivalent vaccine. Two days after receiving vaccine, the patient developed headache, vomiting, dizziness, nausea, malaise, burning sensation (reported as "the blood was burning but had no fever, shivering and flush"). On 05-Oct-2020, five days receiving Fluad Quadrivalent, the patient got the hospital and she found out she was dehydrated and having an acute reaction to the vaccine. Chronology is compatible. The patient's concurrent conditions included Diabetes and hypertension. The patient's concomitant medications included metformin, Lantus (insulin glargine), Bydureon (exenatide), losartan, paroxetine, montelukast, amlodipine, gabapentin, alprazolam, Alprazolam (levothyroxine sodium), trazodone, all for an unreported indication. Causal role of suspect vaccine cannot be excluded and is assessed as possibly related for all events.