Age: 60.0
Sex: F
Vaccine: FLU4, VARZOS
Symptoms: Body temperature increased, Headache, Injection site pain, Oropharyngeal pain, Pyrexia
Clinical narrative: Arm in which she received the shingles vaccine was painful; Fever of 101.5 F; Sore throat; Headache; This spontaneous case was received on 28-Sep-2020 from other non-health professional via agency (reference number: SEQW20-02426) with additional information (reference number: SEQW20-02599) received on 30-Sep-2020 (being processed together) and concerned a 60-year-old, female patient.  The patient's current condition included high blood pressure. The patient had no egg allergy. The patient's concomitant medications included lisinopril used for unreported indication.  On 25-Sep-2020, at approximately 03:00 p.m., the patient was vaccinated with Afluria Quadrivalent (influenza vaccine, dose: 0.5 ml, route of administration: intramuscular, anatomical location: deltoid) for influenza prophylaxis. The batch number was not reported.   On the same day, the patient was vaccinated with varicella zoster vaccine (reported as 'shingles vaccine') (brand not specified, indication, dose, route of administration, anatomical location: arm). The batch number was not reported. It was reported that these immunizations were given in separate arms.  On 25-Sep-2020, in the middle of the night, the patient experienced a fever of 101.5 Fahrenheit. Also, the patient experienced sore throat and headache. The patient's arm in which she received the shingles vaccine was painful, but there was no injection site pain in the arm that she got the influenza vaccination.  On an unspecified date in Sep-2020, the patient contacted CVS to inquire if she should get a COVID test, because of her symptoms. They did not recommend it at that time but advised that should get a COVID test if the symptoms persisted for more than a few days.    On 26-Sep-2020 and 27-Sep-2020, the patient took Advil (ibuprofen) for temperature and it went away.   On an unspecified date in Sep-2020, the patient recovered from fever.   On 28-May-2020, reported by Monday, headache and sore throat were resolved.    The outcome of the event 'painful arm' was not reported.  The reporter did not provide a causality assessment.   The reporter assessed the case as non-serious  Company comment: Pain in extremity (reported as 'arm in which she received the shingles vaccine'), pyrexia, oropharyngeal pain and headache were associated with the use of the suspect product Afluria Quadrivalent. The events occurred the same day after vaccination with the product making chronology suggestive for all events. Also, on the same day when our product was given, the patient was vaccinated with varicella zoster vaccine and the arm in which she received the shingles vaccine was painful, but there was no injection site pain in the arm that she got the influenza vaccination. The patient's current condition included high blood pressure while concomitant medications included lisinopril used for unreported indication. There was also concern of the patient regarding COVID infection, but this was not confirmed. With information presented, causality is assessed as unlikely related for all events (except for pain in extremity which is assessed as unrelated) having in mind chronology, suspicion on COVID and report of another co-suspect product. (''unlikely related'' defaults to ''related'' in the safety database for reporting purposes); Sender's Comments: Pain in extremity (reported as 'arm in which she received the shingles vaccine'), pyrexia, oropharyngeal pain and headache were associated with the use of the suspect product Afluria Quadrivalent. The events occurred the same day after vaccination with the product making chronology suggestive for all events. Also, on the same day when our product was given, the patient was vaccinated with varicella zoster vaccine and the arm in which she received the shingles vaccine was painful, but there was no injection site pain in the arm that she got the influenza vaccination. The patient's current condition included high blood pressure while concomitant medications included lisinopril used for unreported indication. There was also concern of the patient regarding COVID infection, but this was not confirmed. With information presented, causality is assessed as unlikely related for all events (except for pain in extremity which is assessed as unrelated) having in mind chronology, suspicion on COVID and report of another co-suspect product. (''unlikely related'' defaults to "related" in the safety database for reporting purposes)