Age: 43.0
Sex: F
Vaccine: COVID19, FLU4
Symptoms: Headache, Myalgia, Nausea, Pyrexia
Clinical narrative: Confusion; I was freezing cold; Started to feel very fatigued; I was having chills; Light headed and dizzy/Mental fog; headache; Nauseous; Muscle aches; Felt the fever rising; This spontaneous case was retrieved on 18-Nov-2021 from Vaccine Adverse Event Reporting System (VAERS) (reference number: 1840394-1), reported by other non-healthcare professional (consumer) and concerned the 43-years old, female patient.  The patient's relevant medical history was not reported. The patient's concomitant medications included Gabapentin for unreported indication.  On 29-Sep-2021, the patient was vaccinated with Afluria Quadrivalent (influenza vaccine; dose: 'one' as reported, route of administration: intramuscular, anatomical location: right arm (RA), indication: not reported). The batch number was not reported.  On the same day, patient was vaccinated with non-company co-suspect Janssen COVID-19 vaccine (covid-19 vaccine nrvv Ad26 (JNJ 78436735)dose: 'two' as reported, route of administration: intramuscular, anatomical location: left arm (LA), indication: not reported). The batch number was reported was 1855194.  On 29-Sep-2021, about three hours after receiving Janssen Covid-19 vaccine and Afluria Quadrivalent vaccine, the patient started to feel very fatigued, headache, lightheaded, dizzy, and nauseous. The patient went to lay down and literally felt the fever rising in the body. The patient was freezing cold with muscle aches coming on and the headache getting more severe. The patient fell asleep and her husband woke her up in the night because she was having chills so bad that husband thought she was convulsing. The chills and fever went Thursday night into the next day, as reported. Most of the symptoms subsided by the next evening except for the headache, dizziness, confusion, and a mental fog, as reported.  The patient stated that six days past the injection headache, dizziness, and mental fog did not go away. The patient was exhausted and could barely write the report. The patient had missed her work for the week because sick she was sick and stated that condition was awful.  At the time of the initial reporting patient recovered from all events, except 'dizziness', 'headache' and feeling abnormal'.  The reporter did not provide causality assessment.   The case was assessed as non-serious.  Company comment: A 43-years old, female patient was vaccinated with the suspect product Afluria Quadrivalent and non-company co-suspect Janssen COVID-19 vaccine. Within three hours after vaccination the patient developed dizziness, headache, fever, chills, fatigue, nausea, myalgia and was feeling cold. The patient additionally reported confusion. Causality is confounded by concurrent administration of co-suspect vaccine. Information regarding the underlying medical history has not been provided. Causality for confusional state is assessed as not related based on biological implausibility. Based on plausible time relationship causality for the remaining events is assessed as possibly related.; Sender's Comments: A 43-years old, female patient was vaccinated with the suspect product Afluria Quadrivalent and non-company co-suspect Janssen COVID-19 vaccine. Within three hours after vaccination the patient developed dizziness, headache, fever, chills, fatigue, nausea, myalgia and was feeling cold. The patient additionally reported confusion. Causality is confounded by concurrent administration of co-suspect vaccine. Information regarding the underlying medical history has not been provided. Causality for confusional state is assessed as not related based on biological implausibility. Based on plausible time relationship causality for the remaining events is assessed as possibly related.