Age: 34.0
Sex: F
Vaccine: COVID19
Symptoms: Pain in extremity, Somnolence, Suppressed lactation
Clinical narrative: body aches; headache; my supply has dropped; I also have been feeling like i took sedatives/I am having a hard time keeping awake during the day; I have hx of fatigue but the fatigue is really bothersome now.; heart has been fluttering; floating, my body felt very light; very sore arm; This is a spontaneous report from a contactable other hcp (patient). A 34-years-old female non pregnant patient received bnt162b2 (PFIZER COVID-19 VACCINE, Solution for injection, Batch/Lot number was not reported, Expiry date was not reported), dose 2 via an unspecified route of administration, administered in Arm Left on 27Aug2021 14:45 as DOSE 2, SINGLE for covid-19 immunisation,(Age at vaccination-34yrs), Patient was not pregnant at the time of vaccination. Medical history included Hypertension, Premature Atrial Contractions, Asthma, Renal Artery Stenosis from an unknown date and unknown if ongoing, known allergies to Iodine, Contrast Dye, Shellfish, Morphine, Vicodin, Reaction to avocados from an unknown date and unknown if ongoing. Concomitant medication(s) included: PROCARDIA [NIFEDIPINE] 30 MG, Clopidogrel bisulfate (PLAVIX ) 75mg, Prenatal Vitamin (ascorbic acid, betacarotene, calcium sulfate, colecalciferol, cyanocobalamin, ferrous fumarate, folic acid, nicotinamide, pyridoxine hydrochloride, retinol acetate, riboflavin, thiamine mononitrate, tocopheryl acetate, zinc oxide) taken for an unspecified indication, start and stop date were not reported. The patient previously took past drugs iodine, morphine, vicodin and also took first dose bnt162b2(PFIZER COVID-19 VACCINE, Solution for injection, Batch/Lot number was not reported, Expiry date was not reported) via an unspecified route of administration administered in left arm on 06aug2021 at 12.00 pm for covid-19 immunisation. The patient had not received any other vaccine within 4 weeks. On 30Aug2021 the patient experienced Shortly after receiving the vaccine reported by patient itself as, she felt like she was floating, my body felt very light, very sore arm the next two days after that was on 01Sep2021 started experiencing body aches, headaches, and my heart has been fluttering. I also have been feeling like I took sedatives. I have hx of fatigue but the fatigue is really bothersome now. I am having a hard time keeping awake during the day and staying alert to do my job. I am breastfeeding and my supply has dropped. Patient was not diagnosed with COVID-19, prior to vaccination and also not been tested for COVID-19, since the vaccination. Patient received no treatment for the events. The clinical outcome of the events were unknown.  The lot number for the vaccine, [BNT162B2], was not provided and will be requested during follow up.no further information is expected; Sender's Comments: Based on the current available information and the plausible drug-event temporal association, a possible contributory role of the suspect product BNT162B2 to the development of event Cardiac flutter  cannot be totally excluded. The case will be reassessed if additional information becomes available.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.,Linked Report(s) : US-PFIZER INC-202101162607 Maternal/Child case