Age: 40.0
Sex: F
Vaccine: COVID19
Symptoms: Hyperhidrosis, Oxygen saturation, Oxygen saturation decreased, Pain, Syncope
Clinical narrative: Bradycardia; tachycardia; Extreme fatigue; oxygen was 84%; multiple fainting episodes; pulse was 39; pulse was 120; blood pressure was 85/56; she felt hot and sweaty; she felt hot and sweaty; Bruises all over her body from the fainting; it was like she was swimming through syrup and then she went down, the following day it happened again; She was still sore for quite awhile; This is a spontaneous report from a contactable nurse (patient). A 40-year-old female patient received second dose of bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Formulation: Solution for injection, Lot Number: EW0198, Expiration date not reported), via an unspecified route of administration, administered in Deltoid Left on 20Jul2021 14:00 (at the age of 40-year-old) as a single dose for COVID-19 immunisation (reported as almost died from 1st interaction with Covid). Medical history included in 2017 she was in bad car accident that caused a brainstem injury and resulted in most of her current medical conditions, ongoing adrenal insufficiency (HPA access damage; Cortisol average is 2), narcolepsy from 2017 and ongoing, ongoing asthma (Born with it), migraine from 2017 and ongoing (treated with Botox), Velopharyngeal insuffiency from an unknown date (dysphagia, so she chokes frequently when she tries to eat and drink), ongoing Partially blind (no left vision in either eye. Wears glasses), ongoing vertigo (when she tips her head back/ posterior), ongoing 8 Herniated disc (8 discs in her back), ongoing dizziness, ongoing nausea, ongoing cardiac issues, COVID-19 from Oct2020 (She was very ill and had to have multiple steroid treatments to recover). Family history included father died from heart attack at 65 years old. She has allergies to preservatives (Stated she has tremendous allergies to sulfites, sulfa, thimerosal, basically all preservatives). Concomitant medication(s) included hydrocortisone (MANUFACTURER UNKNOWN) taken for adrenal insufficiency from an unspecified start date and ongoing; lisdexamfetamine mesilate (VYVANSE) taken for narcolepsy from an unspecified start date and ongoing; salbutamol (VENTOLIN [SALBUTAMOL]) taken for asthma from an unspecified start date and ongoing; fluticasone furoate, vilanterol trifenatate (BREO ELLIPTA) taken for asthma from an unspecified start date and ongoing; gabapentin (GABAPENTIN) taken for intervertebral disc protrusion from an unspecified start date and ongoing; topiramate (TOPAMAX) taken for migraine from an unspecified start date and ongoing; oxycodone hydrochloride, paracetamol (PERCOCET [OXYCODONE HYDROCHLORIDE;PARACETAMOL]) taken for pain from an unspecified start date and ongoing; hyoscyamine taken for muscle spasms, start and stop date were not reported; meclizine hcl taken for dizziness, vertigo from an unspecified start date and ongoing; ondansetron (ZOFRAN [ONDANSETRON]) taken for nausea from an unspecified start date and ongoing. The patient previously took first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Formulation: Solution for injection, Lot Number: EW0198, Expiration date not reported), via an unspecified route of administration, administered in anterior Deltoid Left on 29Jun2021 14:45 (at the age of 40-year-old) as a single dose for COVID-19 immunisation and experienced sore arm, felt like she had a mild case of COVID for about 5 days, headache, fever, very dizzy and light headed, and almost fainted it may have been a vasovagal reaction. No history of previous immunization with the Pfizer vaccine considered as suspect. No additional vaccines administered on same date of the Pfizer Suspect. No other vaccinations within four weeks prior to the first administration date of the suspect vaccine. Other historical vaccines included Flu vaccine and TDAP. On an unspecified date in Jul2021, the patient experienced oxygen was 84%, multiple fainting episodes, pulse was 39, pulse was 120, blood pressure was 85/56, she felt hot and sweaty, bruises all over her body from the fainting, it was like she was swimming through syrup and then she went down, the following day it happened again, she was still sore for quite a while. On an unspecified date, she experienced tachycardia, bradycardia and extreme fatigue. The consumer stated that she got her 2nd dose of the Pfizer Covid Vaccine on 20Jul2021. Since then, she has had all the other symptoms, and had a fainting episode at the time of the vaccine and multiple other fainting episodes since. Clarifies that the first fainting episode occurred the night after she got the shot, that night when she got up to get some Advil, it was like she was swimming through syrup and then she went down. The following day it happened again. Stated that she had a PulseOx and a blood pressure machine at her house, and her pulse was 39, and oxygen was 84%, which was what it was when she was sick with Covid; but her pulse and oxygen were not staying like that constantly. Stated that the day before, she felt hot and sweaty so she checked her pulse and it was 120. Caller stated that she was small, and typically her blood pressure was low normally, but it was 85/56 the two days before, so she had been all over the place since getting the 2nd dose of the vaccine. She was still sore for quite a while. She believed all her symptoms were directly related to the Covid vaccine, especially since the fainting episode started the day she got the 2nd dose. States she dose feel like she was improving; she's not falling on the ground fainting every day. Stated she has fainted about 6-7 times already; her dog took a hit for her, she fell on the dog instead of hitting the fireplace. Stated that it happened so fast, she tried to stop it, but there's just not always anything she can do. Sometimes she tried to cough to see if that will help, like forcing a vasovagal reaction. Stated that she had bruises all over her body from the fainting. Stated that the fainting could be an interaction with one of her medications, but at least she was alive. Most people with a brainstem injury didn't live. Stated this might be putting more stress on her heart which may not have been fully recovered from her experience with Covid. Stated after having Covid she had some cardiac issues that she was still recovering from. Stated that she did contact her physician, but they haven't contacted her back. She would like to see a Cardiologist, but she needs a referral. Stated that she had tremendous allergies to sulfites, sulfa, thimerosal, basically all preservatives; she has an EpiPen in case she needs it. Stated she can't take nitrates. No further details provided. Adverse events did not required visit to Emergency Room or Physician Office. She did read that some kids had experienced some mild myocarditis, so might be she was experiencing some of that. Caller states that her symptoms are definitely cardiac related; she is having tachycardia, bradycardia, and she knows the symptoms, and has extreme fatigue. She still feels the shots were worthwhile. Stated she was sure she just needs to rest, especially if it is myocarditis because there really isn't a treatment for it. On an unspecified date in Jul2021, the patient underwent lab tests and procedures which included blood pressure: 85/56, pulse: 39, pulse: 120, oxygen: 84%. Verbatim event relatedness: Pfizer Covid Vaccine: 2nd dose: multiple fainting episodes, pulse was 39, and oxygen was 84%, pulse was 120, blood pressure was 85/56 - Related. The outcome of event multiple fainting episodes was resolving whereas outcome of all other events was unknown.; Sender's Comments: Based on the information in the case report and a plausible temporal relationship, a possible causal relationship between the events oxygen saturation decreased, syncope, bradycardia and suspect drug BNT162B2 cannot be excluded 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.