Age: 70.0
Sex: F
Vaccine: UNK
Symptoms: Body temperature increased, COVID-19, Hypersensitivity, Immediate post-injection reaction, Pain
Clinical narrative: Felt it in the left side of her face; Felt it being dispersed through the left side of her face; Body aches; High temperature; An allergic reaction/Felt it being dispersed through the left side of her face; Tested positive for Covid; This spontaneous case was received on 14-Jun-2021 from other non-health professional (consumer) via agency (reference number: SEQW21-01430) and concerned a 70-year-old female patient.  The patient's medical history included unspecified allergy, polio and reflex sympathetic dystrophy (RSD). The patient's concomitant medications included two unspecified allergy mediations and unspecified antacids. The patient historical vaccines included Fluad Quadrivalent every year without issues.  On 16-Oct-2020, the patient was vaccinated with Fluad Quadrivalent (influenza vaccine, inactivated influenza virus surface antigen (subunit), egg-derived, mf59; dose, route of administration and anatomical location: not reported) as prevention of seasonal influenza . The batch number was not reported.  On the same day, the patient had an allergic reaction to the Fluad Quad vaccine, immediately after being administered the vaccine, she ''felt it being dispersed through the left side of her face''. Additionally, that night, the patient experienced high temperature and body aches.  On an unknown day in 2020, two weeks after receiving Fluad Quadrivalent, the patient had a Covid test and tested positive for Covid.  On an unknown day in Feb-2021, the patient received Covid-19 vaccine Moderna (cx-024414 ) and she also ''felt it in the left side of her face''.  The patient did not receive any treatment for the events.  On an unknown day, the patient recoverd from the first episode of the event 'sensory disturbance' and 'allergic reaction'.  The outcome of all other events was unknown.  The reporter assessed the first episode of the event 'sensory disturbance' and 'allergic reaction' as related to Fluad Quadrivalent, but did not provide a causality assessment for any other event. The reporter stated that the patient had an allergic reaction to the Fluad Quad vaccine which she received at pharmacy in 16-Oct-2020. The reporter further stated, the patient had the Fluad Quad vaccine every year and did not have any issues but in 16-Oct-2020 after being administered the vaccine she immediately ''felt it being dispersed through the left side of her face''  Company comment: A 70-year-old, female patient was vaccinated with Fluad Quadrivalent. On the same day, the patient had an allergic reaction to the Fluad Quad vaccine, immediately after being administered the vaccine, she ''felt it being dispersed through the left side of her face''. Additionally, that night, the patient experienced high temperature and body aches. Two weeks after receiving Fluad Quadrivalent, the patient had a Covid test and tested positive for Covid. On an unknown day in Feb-2021, the patient received Covid-19 vaccine Moderna vaccine and she also ''felt it in the left side of her face''. Causality is assessed as possibly related for pain, pyrexia and hypersensitivity. Unevaluable event (reported as felt it being dispersed through the left side of her face) is unassessable, due to unclear information about event. Second occurrence of Unevaluable event is assessed as not related due to implausible chronology and alternative aetiology. Covid-19 is assessed as not related to the suspect vaccine, due to biological implausibility.; Reporter's Comments: The reporter stated that the patient had an allergic reaction to the Fluad Quad vaccine which she received at pharmacy in 16-Oct-2020. The reporter further stated, the patient had the Fluad Quad vaccine every year and did not have any issues but in 16-Oct-2020 after being administered the vaccine she immediately ''felt it being dispersed through the left side of her face''.; Sender's Comments: A 70-year-old, female patient was vaccinated with Fluad Quadrivalent. On the same day, the patient had an allergic reaction to the Fluad Quad vaccine, immediately after being administered the vaccine, she ''felt it being dispersed through the left side of her face''. Additionally, that night, the patient experienced high temperature and body aches. Two weeks after receiving Fluad Quadrivalent, the patient had a Covid test and tested positive for Covid. On an unknown day in Feb-2021, the patient received Covid-19 vaccine Moderna vaccine and she also ''felt it in the left side of her face''. Causality is assessed as possibly related for pain, pyrexia and hypersensitivity. Unevaluable event (reported as felt it being dispersed through the left side of her face) is unassessable, due to unclear information about event. Second occurrence of Unevaluable event is assessed as not related due to implausible chronology and alternative aetiology. Covid-19 is assessed as not related to the suspect vaccine, due to biological implausibility.