Age: 57.0
Sex: F
Vaccine: COVID19, FLU4, COVID19, FLUC3
Symptoms: Chromaturia, Muscle spasms, Pelvic pain, Product administration error, Sleep disorder
Clinical narrative: Muscles spasms in my lower back; Threw up three times; Pee changed color to orange; Front pelvic area was in horrific pain; Did not sleep for two days; The patient was vaccinated with Flucelvax Quadrivalent and Pfizer BioNTech in the same arm on the same day; This spontaneous case was retrieved on 03-Nov-2023 from Vaccine Adverse Event Reporting System (VAERS) (reference number: 2689330-1) reported by other non-healthcare professional (consumer) and concerned a 57-year-old, female patient.   The patient's concurrent conditions included allergy to codeine and penicillin. The patient's historical procedure included removing of spleen and oral surgery. The patient's concomitant medications included clindamycin (discrepantly reported as 'clyndamycen') as dental antibiotic. The patient's historical vaccines included unspecified number of unspecified Covid-19 vaccines, received on unspecified date, for unreported indication after which the patient had zero reactions.  On 24-Sep-2023, the patient was vaccinated with non-company, co-suspect Pfizer BioNTech COVID-19 vaccine (tozinameran; dose reported as '1', route of administration: injection (reported as 'SYR'), anatomical location: left arm, indication: not reported). The batch number reported was HD9835.  It was reported that on same date, the patient was vaccinated with Afluria Quadrivalent (influenza vaccine inact split 4v; dose: reported as '1', route of administration: injection (reported as 'SYR'), anatomical location: left arm, and indication: not reported) (explicitly coded as 'Product administration error'). As reported, pharmacy did not give manufacturer of flu so what was selected might be inaccurate. The batch number reported was 370671. The reported batch number was identified by Seqirus to be linked to suspect product Flucelvax Quadrivalent (influenza vaccine inact sag 4v) instead of reported suspect Afluria Quadrivalent vaccine. Based on the reported batch number, the suspect product was changed to Flucelvax Quadrivalent.  On the same date, after receiving Flucelvax Quadrivalent and non-company, co-suspect Pfizer BioNTech COVID-19 vaccine, the patient experienced massive reaction. The patient throw up three times, created major muscle spasms in lower back, and front pelvic area was in horrific paint, the patient didn't sleep for two days and missed family reunion. The patient reported that her pee changed color to orange. The patient emailed her doctor and called Centers for Disease Control and Prevention (CDC) and pharmacy for help.  At the time of initial reporting, the patient was recovering from the events of 'urine coloring orange', muscle spasms, 'pelvic pain', 'sleep disorder', 'vomiting'. As reported, on 01-Oct-2023, the patient started to feel normal.  The reporter did not provide a causality assessment. As reported, the adverse reaction was to Covid 5 shots.  The case was assessed as non-serious.  Case updated on 27-Nov-2023: Correction made to information received on 03-Nov-2023: On General Tab 'Regulatory Authority' removed from Intermediary and Report Sent to Regulatory Authority changed form 'Yes' to 'UNK'. No changes in narrative.  Company comment: A 57-year-old patient received the suspect product Flucelvax Quadrivalent and non-company co-suspect Pfizer BioNTech COVID-19 vaccine on the same day and in the same anatomical location: left arm (explicitly coded as 'Product administration error'). The patient experienced vomiting, muscle spasms, pelvic pain, chromaturia, and sleep disorder on the same date after vaccination. More information regarding patient's diagnostic findings is needed. Based on biological implausibility, causal role of the suspect vaccine for the events pelvic pain and chromaturia is assessed as not related. Causality for sleep disorder is also assessed as not related since it is considered as a consequence of other events. Causality for the remaining events (vomiting and muscle spasms) is assessed as possibly related, due to suggestive temporal relationship, even though co-suspect vaccine is a confounding factor. Product administration error is assessed as unrelated per company's conventions.; Sender's Comments: A 57-year-old patient received the suspect product Flucelvax Quadrivalent and non-company co-suspect Pfizer BioNTech COVID-19 vaccine on the same day and in the same anatomical location: left arm (explicitly coded as 'Product administration error'). The patient experienced vomiting, muscle spasms, pelvic pain, chromaturia, and sleep disorder on the same date after vaccination. More information regarding patient's diagnostic findings is needed. Based on biological implausibility, causal role of the suspect vaccine for the events pelvic pain and chromaturia is assessed as not related. Causality for sleep disorder is also assessed as not related since it is considered as a consequence of other events. Causality for the remaining events (vomiting and muscle spasms) is assessed as possibly related, due to suggestive temporal relationship, even though co-suspect vaccine is a confounding factor. Product administration error is assessed as unrelated per company's conventions.