Age: 90.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Fluid retention, Immunisation, Insomnia, Oedema
Clinical narrative: DOSE 3 (BOOSTER), SINGLE; blood pressure got out of balance; difficulty in breathing as she was laying flat in bed; severe weakness in her legs; She had a subcutaneous bulge of fluid over her sternum, more of a systemic fluid retention; systemic edema; had an anaphylactic reaction; She was unable to sleep through the night; This is a spontaneous report from a contactable Pharmacist. This Pharmacist reported for a 90-year-old female patient that:  A 90-year-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Batch/Lot number was not reported, Expiry date: unknown), dose 3 via an unspecified route of administration on 2021 (at the age of 90 years old) as dose 3 (booster), single for covid-19 immunisation. Medical history included cardiac failure congestive, macular degeneration, arthritis. She did have a stent put in prior to this. The concomitant medications included blood pressure/cardiac medications for several years. She was on antiarrhythmics but no diuretic. Historical vaccine included bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Lot Number and Expiry date: unknown), via an unspecified route of administration, administered sometime in Feb or Mar2021 as dose 1, single for covid-19 immunisation and experienced mini stroke and loss of vision after dose 1 and as dose 2, single for covid-19 immunisation. After her booster dose, his mother had a spike in blood pressure suddenly. She had difficulty in breathing as she was laying flat in bed. She had a subcutaneous bulge of fluid over her sternum, more of a systemic fluid retention. On an unknown date in 2021 the patient experienced leg weakness and experienced weakness so severe in her legs, she had to basically lie in her recliner most of the day. She wasn't able to function. The second big indicator was that her blood pressure got well out of balance. Normally, his mother's blood pressure is 145/75 or something around that. Her blood pressure was 206/98 when she was being admitted into the hospital. He engaged in discussion with the Hospitalist and Head Nurse, and they basically said they are thinking his mother may have some underlying CHF (congestive heart failure). His mother may have a little congestive heart failure, but he found it odd, she had a spike in blood pressure all of a sudden. His mother also had a bulge, sort of like edema, that subcutaneously manifested itself between her breasts, over her sternum. It was the shape and size of half of a tennis ball, like a sphere. He felt this is more anaphylaxis versus like a pulmonary edema, because pulmonary edema didn't manifest itself like that, this was more of a systemic fluid retention. This was like a subcutaneous bulge of fluid over her sternum. He was going to guess it was there 8 hours, but it had subsided. He clarified the spike in his mother's blood pressure wasn't noted until she was seen at urgent care. Urgent Care referred her to the hospital on 06Nov2021. She was unable to sleep through the night. His mother had to spend the night in the recliner which is unusual for her. She normally slept in her regular bed. However, that episode lasted through the night. The following day, she was clear of any effects. However, 2 nights later, clarified as Friday, 05Nov2021, his mother went to bed feeling fine, but then experienced that same difficulty in breathing as she was laying flat in bed and had to repeat and spend part of the night in the recliner. The next morning, 06Nov2021, she went to Urgent Care, who then referred her to the hospital. He confirmed his mother was admitted into the hospital this past Saturday, 06Nov2021, and was discharged on 07Nov2021. She wasn't on any diuretics in addition to her blood pressure medications. History of previous immunization with the Pfizer vaccine considered as suspect included PFIZER-BIONTECH COVID-19 VACCINE. It was unknown if additional vaccines were administered on same date of the Pfizer suspect. Adverse event Not being able to breathe laying flat, spike in blood pressure required a visit to Emergency Room/Physician Office. Any vaccinations (within 4 weeks) prior to the first administration date of the suspect vaccine were not provided. No Adverse events following prior vaccinations. Relevant Tests included creatinine clearance. The only other hospitalization issue she had since the whole late winter/early spring and the start of the vaccination program, is his mother experienced somewhat of a mini stroke where she had a loss of vision in one eye. His mother did have macular degeneration and she lost vision, but the doctor related this to a mini stroke. She was put on a blood thinner, Xarelto, and was pretty much stabilized on that. It had been several months ago, like 4-5 months. He confirmed this event happened after she received her first dose of the Pfizer COVID vaccine. This all happened within this year. He knew his mother received her initial doses early on in February or March. The date written for the Xarelto is 19 May 2021. His mother's blood pressure was under control. They just plan to get her to her cardiologist and her family physician so they can understand her new medical regimen. From her admission to the hospital, they added a 30 day adjunct to her regular medication regimen including losartan and furosemide which is all tolerable. He believed the events his mother experienced after the booster dose are related to the vaccine itself. The patient was hospitalized for difficulty in breathing as she was laying flat in bed from 06Nov2021 to 07Nov2021. The patient underwent lab tests and procedures which included blood pressure measurement: 145/75 on an unspecified date, blood pressure measurement: 206/98 on 06Nov2021. The outcome of the events was unknown.  Description of complaint included: Caller is a pharmacist calling to report on behalf of his mother in regards to her experience with the booster dose of the Pfizer COVID vaccine. He explains his mother is really on cue with her medical regimen. She keeps her blood pressure on check. His mother has been on the same regimen and blood pressure/cardiac medications for several years. She is on antiarrhythmics but no diuretic. She was placed on a blood thinner, Xarelto. The date written for the Xarelto is 19 May 2021. When probed for product information for the Xarelto, he provides the following: NDC: 50458-0578-30, Lot: Unknown, Expiry date: Unknown.  The lot number for the vaccine BNT162B2 was not provided and will be requested during follow up.; Sender's Comments: Based on available information and a possible contributory role of suspect product BNT162B2 to the development of events cannot be totally 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 RAs, Ethics Committees, and Investigators, as appropriate.