Age: 28.0
Sex: F
Vaccine: COVID19, FLUC3
Symptoms: Dyspnoea, Feeling abnormal, Hypoaesthesia, Nausea, Paraesthesia
Clinical narrative: Slouched down in the chair; Hands felt numb; Breathing heavy; Hands were tingling; Felt funny; Nauseous; Covid vaccine hurt a little bit going in; This spontaneous case was retrieved on 16-Nov-2023 from the Vaccine Adverse Event Reporting System (VAERS) (reference number: 2701492-1), reported by other healthcare professional, and concerned a 28-year-old, female patient.  The patient's medical history and concomitant medications were not reported. The patient had no known allergies.  On 25-Oct-2023, the patient was vaccinated with Flucelvax Quadrivalent (influenza vaccine inact sag 4v; dose: 0.5 ml; route of administration: intramuscular (IM); anatomical location: right arm (RA)) for influenza immunization. The batch number reported was 944482 (reported batch number was identified by Seqirus to be correct batch number).  On the same date, the patient was vaccinated with a non-company, co-suspect Novavax COVID-19 vaccine (active ingredients not specified; dose: 0.5 ml; route of administration: intramuscular (IM); anatomical location: left arm (LA)) for COVID-19 immunisation. The batch number reported was 5683MF008.  On the same date, after receiving Flucelvax Quadrivalent and non-company, co-suspect Novavax COVID-19 vaccine, during the 15-minute observation time, around 10:19 am, the patient was slouched down in the chair. The patient was able to communicate and said her hands were tingling, felt numb, and that she was breathing heavy. Also, the patient said the Covid vaccine hurt a little bit going in. The patient said she felt funny and nauseous. Emergency medical technician (EMT) was contacted around 10:35 am and when they arrived, they took the patient's vitals, and she was given water. The patient declined to leave with EMT, and they left the pharmacy around 10:50 am. The patient's father came and took her home at 11:24 am.  The outcome of the events was unknown.  The reporter did not provide a causality assessment.   The case was assessed as non-serious.  Additional information received on 21-Nov-2023 from Med Communications (reference number: SEQW23-04427): Two reporters added. Dose and indication added for suspect and co-suspect vaccines. Additional references added. The narrative was amended accordingly.   Case updated on 05-Dec-2023: Correction made to information received on 21-Nov-2023: Coding of the event coded as LLT: 'Pain localized'/PT: 'Pain' amended to LLT: 'Vaccination site pain'/ PT: 'Vaccination site pain'. As Determined Causality changed from 'Related' to 'Not related' for this event. As Determined Listedness amended for this event. Events rearranged. No changes in the narrative. Company comment amended accordingly.   Additional non-significant information received on 15-Dec-2023 from Med Communications (reference number: SEQW23-04869): Additional reference number added. No changes in the narrative.  Company comment: A 28-year-old, female patient was vaccinated with the suspect product Flucelvax Quadrivalent (anatomical location: right arm) and non-company, co-suspect Novavax COVID-19 vaccine (anatomical location: left arm). On the same day after vaccination during the 15-minute observation time, the patient was slouched down in the chair. The patient was able to communicate and said her hands were tingling, felt numb, and that she was breathing heavy. The patient also said she felt funny and nauseous. In addition, patient complained of COVID vaccine was hurting a little bit going in. Information regarding the underlying medical history and concomitant medications has not been provided. Based on plausible temporal relationship causality for the events posture abnormal, hypoaesthesia, dyspnoea, feeling abnormal, paraesthesia and nausea is assessed as possibly related. Due to etiological factor provided (COVID vaccine), causality for vaccination site pain is assessed as not related.; Reporter's Comments: A 28-year-old, female patient was vaccinated with the suspect product Flucelvax Quadrivalent (anatomical location: right arm) and non-company, co-suspect Novavax COVID-19 vaccine (anatomical location: left arm). On the same day after vaccination during the 15-minute observation time, the patient was slouched down in the chair. The patient was able to communicate and said her hands were tingling, felt numb, and that she was breathing heavy. The patient also said she felt funny and nauseous. In addition, patient complained of COVID vaccine was hurting a little bit going in. Information regarding the underlying medical history and concomitant medications has not been provided. Based on plausible temporal relationship causality for the events posture abnormal, hypoaesthesia, dyspnoea, feeling abnormal, paraesthesia and nausea is assessed as possibly related. Due to etiological factor provided (COVID vaccine), causality for vaccination site pain is assessed as not related.