Age: 68.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Dizziness, Fatigue, Immediate post-injection reaction, Limb discomfort, Nausea
Clinical narrative: feels tired; She did have palpitations overnight that woke her up in her sleep for 15 minutes; head feels tight, like there is a band around it/head feels tight, like there is a band around it; Nausea; severely lightheaded; her limbs felt heavy; her blood pressure went way up and lasted a good 7 hours/blood pressure at this time was elevated to 190/86; it was hard to lift her arms; This is a spontaneous report received from a contactable two nurses (one nurse reported for herself). This 68-year-old female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, lot number: EN6205 and expiration date: 30Jun2021), via an unspecified route of administration right arm on 29Mar2021 at 10:15 as single dose for COVID-19 immunization. Medical history included anaphylaxis (recovering), hypertension ongoing, gastroesophageal reflux disease (GERD), anemia (her hemoglobin dropped to 6.9 and ferritin was low), hiatal hernia surgery (had mesh), a latex allergy (her lips would start swelling) and food allergy (tuna fish). Family history included lung disease (her dad was diagnosed). Concomitant medications included hydrochlorothiazide (HCTZ) 25 mg, daily (been on it for 10 years) taken for high blood pressure from an unspecified start date and ongoing; losartan 100 mg, daily (for about 10 years) taken for hypertension from an unspecified start date and ongoing; iron (Tablet) 65 mg, daily (about 10 years ) taken for anaemia, cetirizine hydrochloride (ZYRTEC) taken for an unspecified indication; The patient previously took cefalexin (KEFLEX) and experienced swelling on face and mouth, epipen, acetylsalicylic acid (ASPIRIN) (6 years ago aspirin sensitivity took place) and experienced haematuria, tolectin as nonsteroidal anti-inflammatory drug (NSAIDS) (about 30 years ago (received steroids, breathing treatments and benadryl) and experienced anaphylactic reaction, flu vaccine taken for flu (at 19 years old). The patient got first vaccine on 29Mar2021 and had an event. On the same day, she was severely light headed and her limbs felt heavy and her blood pressure went way up and lasted a good 7 hours. They had her in the emergency room. She did have palpitations overnight that woke her up in her sleep for 15 minutes but she had no chest pain or shortness of breath and then it went away. At first, she didn't feel anything, but then as soon as she got up to go to the sitting area where she was supposed to wait for 15 minutes, she became very very light headed, almost like there was a band around your head. there was no dizziness, but she was lightheaded and all four of her limbs felt really heavy, it was hard for her to move her limbs, she experienced nausea while sitting in the waiting area as well. She did not throw up and it started about an hour after the vaccine and describes the nausea as fleeting and states it lasted about a couple of hours, but not as long as the light headedness and heavy limbs. her blood pressure at this time was elevated to 190/86. the doctor there told them to send her to the ER. The reporter stated that the vaccine was given at the hospital, so they just wheeled her to the emergency department within the hospital, the doctor in the emergency room told her they didn't think it was an allergic reaction. after about 6 hours around 1600 her blood pressure finally came down to 141/67. She was discharged from the emergency room around 16:00 on 29Mar2021. At the time of discharge, the heaviness of limbs and light headedness had went away, but when she was walking to get to her car in the parking lot the lightheadedness and heaviness of her limbs returned. it was hard to lift her arms. she went home and went to bed, the lightheadedness and heaviness of her limbs went away after she was able to lay down and rest. Last night around 2:30 or 3:00am she woke up with heart palpitations. Caller states that these palpitations went away after 15 min and that she hasn't had this experience in years since hiatal hernia surgery. she felt much better next day, the only thing she felt today was tightness in her head but not a headache and just felt tired. The outcome of the events severely lightheaded, her limbs felt heavy, her blood pressure went way up and lasted a good 7 hours/blood pressure at this time was elevated to 190/86 and head feels tight, like there is a band around it were recovered in 2021; nausea was recovered on 29Mar2021; palpitations was recovered on 30Mar2021 and other events were unknown.  As reported causality : Feeling light headed; Limbs felt really heavy; high blood pressure Related; head feels tight, like there is a band around it; heart palpatations Related.  Information on Lot/Batch number was available. Additional information has been requested.; Sender's Comments: Based on the reasonable temporal association, the Company cannot completely exclude the possible causality between the reported events and the administration of the suspect COVID19 vaccine, BNT162B2.   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 RA, IEC, as appropriate.