Age: 49.0
Sex: F
Vaccine: COVID19, FLUC3
Symptoms: Headache, Muscle spasms, Myalgia, Nausea, Pain
Clinical narrative: Cramping; Upset stomach; Muscle aches; Asthma attacks; Broncho spams; Body aches; Nausea; Chills; Low grade fever (highest temperature 100.2F); Headaches; This spontaneous case was received on 22-Nov-2022 from other non-health professional (consumer) via Regulatory Communications with an additional information received on the same day (being processed together) (reference numbers: SEQW22-06008) and concerned a 49-year-old, female patient.  The patient's concurrent conditions included gastrooesophageal reflux disease (GERD), irritable bowel syndrome (IBS), asthma, and vision impairment. The patient's concomitant medications included omeprazole for GERD, amitriptyline for IBS, and Ventolin (salbutamol sulfate) for asthma. The patient's past medical history included an aneurysm. The patient's historical procedure included a loop electrosurgical excision procedure (LEAP), upper endoscopy and implantation of two metal clips in the right forehead. The patient's historical vaccines included three doses of Pfizer/Biontech Covid-19 vaccine: first dose received on 31-Mar-2021, in the left arm, batch number: EW0150, second dose received on 25-Apr-2021, in the left arm, batch number: EW0170 and third dose (booster) received on 25-Nov-2021, in the left arm, batch number: FF2590. All were used for unreported indication, after which the patient experienced unspecified adverse events including vomiting and swollen lymph node in the left armpit after the first dose. The patient's historical vaccines also included vaccine against measles, mumps and rubella (MMR), Tuberculosis vaccines (TB), Hepatitis A (HepA), Hepatitis B vaccine (HepB), tetanus, flu, and polio vaccine, all received on an unspecified date(s), used for unreported indications, and after which the patient experienced sore arm. The patient's mother's medical history included high cholesterol and asthma, and the patient's father's medical history included high cholesterol. On 11-Feb-2021, 28-Jun-2021, 02-Feb-2022, and on 03-Jun-2022, the patient had Human papilloma virus (HPV) tests done and all were negative.   On 30-Sep-2022, the patient was vaccinated with Flucelvax Quadrivalent (influenza vaccine inact sag 4v; anatomical location: left arm, dose and route of administration: not reported) for active immunization against influenza caused by influenza virus subtypes A and types B contained in the vaccine. The batch number reported was AS45038, closest to be the actual lot number AS4503A.  On 19-Oct-2022, the patient was also vaccinated with non-company, co-suspect Pfizer-BioNTech COVID-19 vaccine (tozinameran; anatomical location: left arm, dose, route of administration, and indication: not reported). The batch number reported was GH9693.  On the same date, around 02:00 PM, after receiving non-company, co-suspect Pfizer-BioNTech COVID-19 vaccine and 19 days after receiving Flucelvax Quadrivalent, the patient experienced headaches, and at 09:00 PM chills. Around 11:00 PM the patient experienced a fever.   On 20-Oct-2022 at 01:30 AM, one day after receiving non-company, co-suspect Pfizer-BioNTech COVID-19 vaccine and 20 days after receiving Flucelvax Quadrivalent, the patient took 450 mg of Tylenol (paracetamol) orally. Nausea started half an hour later but ginger ale reduced it. At the same time, the patient also experienced asthma attacks/broncho spasms, which stopped with Ventolin.  On the same date, at 08:00 AM, the patient experienced body aches, low grade fever (highest temperature 100.2 Fahrenheit (F)), and muscle aches. No medication was taken. In addition, the patient also experienced an upset stomach and cramping at the same time, which forced the patient into a liquid diet.  On 19-Oct-2022, the patient recovered from the event of chills.  On 20-Oct-2022, the patient recovered from the events of asthmatic attack, bronchial spasm, low grade fever and muscle ache.  On 21-Oct-2022, the patient recovered from the events of cramps and upset stomach. On an unspecified date in 2022, the patient recovered from the events of general body pain, nausea and headache.  The reporter did not provide a causality assessment.  The case was assessed as non-serious.  Company comment: A 49-year-old female patient experienced headache and chills 19 days after being vaccinated with the suspect Flucelvax Quadrivalent vaccine and on the same date after being vaccinated with co-suspect Pfizer-BioNTech COVID-19 vaccine. Next day, the patient experienced nausea, asthma, bronchospasm, pain, pyrexia and myalgia, muscle spasms and abdominal discomfort. The patient's concurrent conditions included asthma and irritable bowel syndrome. Considering implausible temporal relationship, and confounding with co-suspect vaccine and concurrent conditions, causality for all events is assessed as not related to the suspect vaccine.; Sender's Comments: A 49-year-old female patient experienced headache and chills 19 days after being vaccinated with the suspect Flucelvax Quadrivalent vaccine and on the same date after being vaccinated with co-suspect Pfizer-BioNTech COVID-19 vaccine. Next day, the patient experienced nausea, asthma, bronchospasm, pain, pyrexia and myalgia, muscle spasms and abdominal discomfort. The patient's concurrent conditions included asthma and irritable bowel syndrome. Considering implausible temporal relationship, and confounding with co-suspect vaccine and concurrent conditions, causality for all events is assessed as not related to the suspect vaccine.