Age: 38.0
Sex: F
Vaccine: COVID19
Symptoms: Muscle spasms, Pain, Pain in extremity, SARS-CoV-2 test, Swelling
Clinical narrative: Swelling of the supraclavicular region/little bit swelling in the neck; shortness of breath/cannot breathe; cough; chest pain; headache; cramping in the arm where I received the vaccine; pain; I feel really bad; I have pain in my arm, the side that I received the vaccine; This is a spontaneous report received from a contactable reporter(s) (Other HCP). The reporter is the patient.  A 38 year-old female patient (not pregnant) received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection), intramuscular, administered in arm right, administration date 28Jan2022 14:45 (Lot number: Fe3594) at the age of 38 years as dose 3 (booster), single for COVID-19 immunisation. Relevant medical history included: "Asthma overcome in adolescence" (unspecified if ongoing). The patient was not pregnant at time of vaccination. The patient had no known allergies. The patient was not diagnosed with COVID-19 prior to vaccination. Concomitant medication(s) included: FLU taken for influenza immunisation, administration date 16Jan2022. Vaccination history included: BNT162B2 (Dose Number: 2, Batch/Lot No: Cr8731, Location of injection: Arm Right, Vaccine Administration Time: 12:00 PM), administration date: 08May2021, when the patient was 37 years old, for COVID-19 immunisation; BNT162B2 (Dose Number: 1, Batch/Lot No: Ew0162, Location of injection: Arm Right, Vaccine Administration Time: 01:00 PM), administration date: 18Apr2021, when the patient was 37 years old, for COVID-19 immunisation. The following information was reported: SWELLING (prolonged hospitalization) with onset 31Jan2022 04:00, outcome "not recovered", described as "Swelling of the supraclavicular region/little bit swelling in the neck"; DYSPNOEA (prolonged hospitalization) with onset 31Jan2022 04:00, outcome "not recovered", described as "shortness of breath/cannot breathe"; COUGH (prolonged hospitalization) with onset 31Jan2022 04:00, outcome "not recovered", described as "cough"; CHEST PAIN (prolonged hospitalization) with onset 31Jan2022 04:00, outcome "not recovered", described as "chest pain"; HEADACHE (prolonged hospitalization) with onset 31Jan2022 04:00, outcome "not recovered", described as "headache"; MUSCLE SPASMS (prolonged hospitalization) with onset 31Jan2022 04:00, outcome "not recovered", described as "cramping in the arm where I received the vaccine"; PAIN (prolonged hospitalization) with onset 31Jan2022 04:00, outcome "not recovered", described as "pain"; FEELING ABNORMAL (prolonged hospitalization) with onset 31Jan2022 04:00, outcome "not recovered", described as "I feel really bad"; PAIN IN EXTREMITY (prolonged hospitalization) with onset 31Jan2022 04:00, outcome "not recovered", described as "I have pain in my arm, the side that I received the vaccine". The patient underwent the following laboratory tests and procedures: SARS-COV-2 test: (06Feb2022) negative, notes: Nasal Swab. Therapeutic measures were taken as a result of swelling, dyspnoea, cough, chest pain, headache, muscle spasms, pain, feeling abnormal, pain in extremity. The patient took Tylenol and drunk hot water with Lemon and Honey and Garlic capsules (Kyolic) number 103 formula as treatment for the events.; Sender's Comments: There is a reasonable possibility based on known safety profile and plausible temporal association that the events are related to the suspected vaccine. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to regulatory authorities, Ethics Committees, and Investigators, as appropriate.