Age: 68.0
Sex: F
Vaccine: COVID19
Symptoms: Asthenia, Blood pressure increased, Body mass index, Body temperature, Confusional state
Clinical narrative: This is a spontaneous report from a contactable consumer (patient). A 68-years-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: Solution for injection, Lot number: EN6202, Expiration date was not reported), via intramuscular route in the Arm left on 24Feb2021 15:50, as 1ST DOSE, SINGLE DOSE for COVID-19 immunisation. The patient medical history included Mitral valve prolapse in 2005, Colon cancer in 2016, 2016 Colon cancer sigmoidectomy allergic reaction to the chemo, Chemo 6 months from March 2016 to 16Aug2016; whole body constricted including throat closing; Allergy, L knee pain Arthritis and Constipation. Family medical History included: Father Side of family- Heart disease, diabetes and Mother Side- Crohn's disease, colon cancer. The patient's concomitant medications included ibuprofen (IBUPROFEN) for L knee pain arthritis twice daily by oral from 2016 and still ongoing; cetirizine hydrochloride (ZYRTEC [CETIRIZINE HYDROCHLORIDE]) for Allergy, 1 dose per day by oral route, every night from 2017 and still ongoing; plantago ovata (METAMUCIL [PLANTAGO OVATA]) for Constipation by oral from 2018, PRN (as needed). The patient received BNT162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: Solution for injection, Lot number: ER2613, Expiration date was not reported), via intramuscular route in the Arm left on 17Mar2021 15:50, as 2nd DOSE, SINGLE for COVID-19 immunization. The patient stated that she had 1st shot in her lunch hour. The patient stayed in hospital for 1/2 hour for any reaction she might have because she had a chronic reaction to chemotherapy since 2015, later clarified to 2016. She left and it takes 20 minutes for her to get home and back to work, and then her arm injection site was tingling with numbing to her fingertips. she got to work and it was so busy she jumped in working, then a little while later saw she had a bruise to the top of her hand where the wrist meets the top of where her hand starts, about the size of a fifty cent piece. She says she knows she didn't hit it, she would have felt the tingling if she had. She said that her bruise is starting to go away. She said that she called her pharmacy and they suggested for her to go to the urgent care, which she did. She says the urgent care said they hadn't heard about bruise like this. She also has a headache, is nauseous, has pain at the injection site, is feeling yucky, and has tiredness. She says the provider at the urgent care suggested and said that she had the injection and chose to take the next day off work, and that she had same symptoms though she didn't have a bruise. She said that her vaccine card has a sticker on it that has first dose, product name, health provider facility, though it was given at a supermarket or grocery store. She said that her numbness and tingling are getting better, she just feels fatigued and tired. She says she is sensitive to stuff anyway. Historical AE/PC: Patient said she doesn't remember the name of the chemotherapy that she had a chronic reaction to and doesn't have the NDC/LOT/EXP to provide from it. She says she was gonna compare ingredients after she got the injection to see if there was anything similar. She says that the urgent care said her BP was high when they took that, then said just her excitement of having done, she says that hers is never high. She said she hadn't eaten since breakfast, though she doesn't know whether that would have anything to do with that, she didn't feel well, and still doesn't so she didn't go to work. The urgent care said if anything else happened to go back there or to emergency room, like if she had shortness of breath or was feeling more of what she had. On follow up(09Apr2021): On 24Feb2021, she noticed her left arm injection site where she had the shot was feeling numbness with tingling to her fingertips on the whole arm. On an unspecified date the patient got back to work and noticed that the top of her left hand was bruised about a size of fifty cent piece at wrist, very wined because she doesn't remember bumping it anywhere. Then she started feeling nausea, confused, headache, Injection site pain and she just feels fatigued and tired. She gave her daughter's phone number to one of her co-worker's and told her, if anything happens to her, to call her daughter. The patient took the next day off from her job because she had no energy. She went to urgent care after next. she didn't feel well, urgent care said her BP was high. All the events were non-serious. The patient underwent lab tests and procedures which included bp was high, blood pressure increased: 153/95, blood pressure increased: 120/80- Normal , blood pressure increased: 160/77 on 07Apr2021, body mass index: 23.56 on 24Feb2021, body mass index: 23.38 on 07Apr2021, body temperature: 97.6 degree Fahrenheit on 24Feb2021, body temperature: 97.5 degree Fahrenheit on 07Apr2021, heart rate: pulse 96 on 24Feb2021, heart rate: pulse 85 on 07Apr2021, oxygen saturation: 98 % on 24Feb2021, oxygen saturation: 97 % on 07Apr2021, respiration: 15 on 24Feb2021, respiration: 20 on 07Apr2021, COVID-19 test: negative on 15May2020. The outcome of the event injection site paraesthesia, hypoesthesia, contusion was recovering, other events are unknown. Follow-up (09Apr2021): New information received from a contactable consumer in response to HCP letter sent which includes: Patient's medical history, family history, lab data and narrative updated. Follow-up (18May2021): New information received from a contactable consumer in response to HCP letter sent which includes: concomitant drugs details and lab data updated. No follow-up attempts are possible. No further information is expected.