Age: 52.0
Sex: F
Vaccine: FLU4
Symptoms: Abdominal discomfort, Dizziness, Gastrointestinal disorder, Headache, Hot flush
Clinical narrative: Felt aching; Stomach is gurgling, like she is hungry; Pain in right rib; Hot flash; Dizziness; Felt like throwing up; Headache; Couldn't sleep last time because her stomach didn't stop gurgling; This spontaneous case was received on 24-Nov-2020 from other non-health professional (consumer) via Med Communications (reference number: SEQW20-05404) and concerned a 52-year-old female patient.  The patient had no relevant medical history and was not taking any concomitant medications. The patient's past drug included Levaquin (levofloxacin) for unreported indication.   On 19-Nov-2020, the patient was vaccinated with Afluria Quadrivalent (influenza vaccine, dose: 0.5 ml, route of administration: intramuscular and anatomical location: not reported) for influenza prophylaxis. The batch number reported was 733126.  On 20-Nov-2020 in the morning, one day after receiving Afluria Quadrivalent, the patient experienced pain in right rib, hot flash, dizziness, and felt like throwing up.   On 23-Nov-2020, the patient felt aching and her stomach was gurgling, like she was hungry.   On an unspecified date in Nov-2020, patient felt headache for a few days and could not sleep last time because her stomach did not stop gurgling.   On 22-Nov-2020, reported as Sunday night, the patient was treated with ibuprofen and antihistamine.  On an unknown date in Nov-2020, the patient recovered from the event of headache.  At the time of initial reporting on 24-Nov-2020, the patient had not recovered from events 'rib pain', 'hot flashes', 'ache', 'gastric sounds abnormal', 'difficulty sleeping', dizziness and nausea, as they were not improved.   The reporter did not provide a causality assessment.  The reporter assessed the event as non-serious.  Company comment: A 52-year-old female patient developed musculoskeletal chest pain (reported as rib pain), hot flush, pain (no further specified), gastrointestinal sounds abnormal, insomnia, dizziness, headache and nausea after vaccination with the suspect product, Afluria Quadrivalent. Due to lack of information regarding temporal relationship, chronology for the events insomnia and headache needs more clarification. Chronology is plausible for all other events. As reported, the patient had no relevant medical history and was not taking any concomitant medications. With information presented, events of musculoskeletal chest pain and gastrointestinal sounds abnormal is assessed as unlikely (defaults to related in the safety database for reporting purposes). Due to biological implausibility causality for the event insomnia is assessed as not related. Causality for all other events is assessed as possibly related.; Sender's Comments: A 52-year-old female patient developed musculoskeletal chest pain (reported as rib pain), hot flush, pain (no further specified), gastrointestinal sounds abnormal, insomnia, dizziness, headache and nausea after vaccination with the suspect product, Afluria Quadrivalent. Due to lack of information regarding temporal relationship, chronology for the events insomnia and headache needs more clarification. Chronology is plausible for all other events. As reported, the patient had no relevant medical history and was not taking any concomitant medications. With information presented, events of musculoskeletal chest pain and gastrointestinal sounds abnormal is assessed as unlikely (defaults to related in the safety database for reporting purposes). Due to biological implausibility causality for the event insomnia is assessed as not related. Causality for all other events is assessed as possibly related.