Sex: F
Vaccine: COVID19, UNK
Symptoms: Chills, Cough, Oropharyngeal pain, Product administered at inappropriate site, SARS-CoV-2 test
Clinical narrative: Blood was on the bandaid; area between her breast and under her arm is slightly tender; The vaccine was administered higher than normal, like on the edge of her shoulder; Rash at the injection site; Administration of the vaccine was very painful; A lump at the injection site exactly where she received her FLUAD vaccine; Sore throat; Cough; Chills; This spontaneous case from US was received on 30-Dec-2021 via Med Communications (reference number: SEQW21-06418), reported by other healthcare professional (consumer) and concerned an adult, female patient older than 65 years, as reported.   The patient's relevant medical history included asthma. The patient's concomitant medications were not reported.   On 21-Nov-2021, 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, anatomical location: left arm) (explicitly coded as 'Product administered at inappropriate site') for influenza prophylaxis. The batch number reported was 312869.  On an unspecified date in Nov-2021, (a week after the Fluad vaccine, as reported), the patient was vaccinated with non-company co-suspect Moderna COVID-19 vaccine (Elasomeran: dose, route of administration and indication: not reported, anatomical location: left arm). The batch number was not reported.   On an unspecified date in 2021, patient reported that the vaccine was administered higher than normal, like on the edge of her shoulder, even though the paperwork stated that it was administered in the left deltoid. Patient also stated that the pharmacist went in at an angle when she had administered the vaccine and administration was very painful. Patient also stated that a small amount of blood was on the band aid after she had removed it, which was not normal for her. Patient stated that on 28 -Dec-2021, she went to receive an infusion and the nurse stated that she noticed a lump at the injection site exactly where she received her FLUAD vaccine. The lump was painless, the size of a quarter, and the nurse stated that it felt soft to the touch. Patient stated that the lump was sticking out about an inch and the area between her breast and under her arm was slightly tender. The lump itself did not hurt, was raised, and white, as reported. Patient also stated that she got a Moderna COVID vaccine in her left arm a week after the Fluad vaccine and developed a rash at the injection site afterwards. Patient stated that the COVID vaccine was administered much lower and the rash eventually went away. Patient also stated that she had a sore throat, cough and chills since weekend before initial report and got a COVID test, which came out negative. Patient was very upset about the lump and stated that it was making her extremely depressed to see it. Patient was worried that it would be permanent. Patient did not wish to provide additional information and was concerned about what this lump could be. On an unspecified date in 2021, patient recovered from vaccination site rash.   At the time of the initial reporting, patient had not recovered from other events.   The reporter did not provide causality assessment.  Case was assessed as non-serious.  Company comment: A 65-year-old patient experienced mass, haemorrhage, rash, and pain of vaccination site, as well as sore throat, cough, tenderness, and chills within a month after receiving the suspect product Fluad Quadrivalent. Non-company co-suspect Moderna COVID-19 vaccine contributed to the development of the event vaccination site rash. The patient's concomitant medications were not provided. Due to lack of information and unclear time relationship, causality is unassessable, except for the event vaccination site rash, which is assessed as not related, based on confounding factor. Product administered at inappropriate site is assessed as unrelated per company convention.; Sender's Comments: A 65-year-old patient experienced mass, haemorrhage, rash, and pain of vaccination site, as well as sore throat, cough, tenderness, and chills within a month after receiving the suspect product Fluad Quadrivalent. Non-company co-suspect Moderna COVID-19 vaccine contributed to the development of the event vaccination site rash. The patient's concomitant medications were not provided. Due to lack of information and unclear time relationship, causality is unassessable, except for the event vaccination site rash, which is assessed as not related, based on confounding factor. Product administered at inappropriate site is assessed as unrelated per company convention.