Age: 68.0
Sex: M
Vaccine: FLUA4, PPV, TD
Symptoms: Body temperature increased, Fatigue, Injected limb mobility decreased, Injection site pain, Loss of personal independence in daily activities
Clinical narrative: Unable to do regular activities; Could not raise my arm beyond 20 degrees without increased pain; could not abduct my upper atm to 90 degrees; Could not raise my arm beyond 20 degrees without increased pain; could not abduct my upper atm to 90 degrees; Soreness right arm/pain left upper arm; Myalgias; Elevation of temperature; Malaise; Fatigue; Cannot sleep on left side; This spontaneous case was retrieved on 14-Jan-2021 from Vaccine Adverse Event Reporting System (VAERS), reported by other non-health professional (consumer) and concerned a 68-year-old, male patient.  The patient's concurrent conditions included latex allergy. The patient's concomitant medications included B12 (cyanocobalamin), unspecified vitamin A, unspecified vitamin D, Osteo Bi-Flex (chondroitin sulfate; glucosamine hydrochloride), all used for an unreported indication.  On 11-Dec-2020, the patient was vaccinated with Fluad Quadrivalent (influenza vaccine, inactivated influenza virus surface antigen (subunit), egg-derived, mf59; dose: reported as one, route of administration: intramuscular, anatomical location: right arm and indication: not reported). The batch number reported was 279799.  On the same day, the patient was also vaccinated with non-company, co-suspect vaccines: Pneumovax (pneumococcal vaccine polysacch 23v; dose: reported as one, route of administration: intramuscular, anatomical location: left arm, batch number: s012247 and indication: not reported) and tetanus and diphtheria toxoids adsorbed (brand not specified; dose: reported as one, route of administration: intramuscular, anatomical location: left arm, batch number: U6669AA and indication: not reported).   On the same day after receiving Fluad Quadrivalent and co-suspects Pneumovax and tetanus and diphtheria toxoids adsorbed, the patient developed malaise, myalgias, mild elevation of temperature and fatigue. He was unable to do regular activities. The patient used Tylenol (paracetamol) at unknown dose as corrective treatment and it helped. He spent following day on the couch. Also, the patient had mild soreness in his right arm, moderate to severe pain in his left upper arm, he could not raise his arm beyond 20 degrees without increased pain and could not abduct his upper arm to 90 degrees. The patient still could not sleep on left side for at least three nights.  At the time of initial reporting, the patient had not recovered from the events.  The reporter did not provide causality assessment.   The event of 'activities of daily living impaired' was considered to be medically significant by a Physician within Seqirus' Pharmacovigilance and Risk Management Department.  Company comment: A 68-year-old patient was vaccinated with Fluad Quadrivalent. On the same day, the patient was also vaccinated with non-company, co-suspect vaccines: Pneumovax and tetanus and diphtheria toxoids adsorbed. On the same day after vaccination, the patient developed malaise, myalgias, pain in extremity, mobility decreased, mild elevation of temperature and fatigue. Reportedly, the patient was unable to do regular activities (Loss of personal independence in daily activities). The patient still could not sleep on left side due to pain. Sleep disorder is assessed as not related to the suspect vaccine. Causal role of the suspect vaccine cannot be excluded and is assessed as possibly related for remaining events.; Sender's Comments: A 68-year-old patient was vaccinated with Fluad Quadrivalent. On the same day, the patient was also vaccinated with non-company, co-suspect vaccines: Pneumovax and tetanus and diphtheria toxoids adsorbed. On the same day after vaccination, the patient developed malaise, myalgias, pain in extremity, mobility decreased, mild elevation of temperature and fatigue. Reportedly, the patient was unable to do regular activities (Loss of personal independence in daily activities). The patient still could not sleep on left side due to pain. Sleep disorder is assessed as not related to the suspect vaccine. Causal role of the suspect vaccine cannot be excluded and is assessed as possibly related for remaining events.