Age: 64.0
Sex: F
Vaccine: COVID19
Symptoms: Heart rate, Heart rate increased, Hypertension, Insomnia, Investigation
Clinical narrative: she feels like she was going to die; My left shoulder is really hurting it's radiating into my scapula and having trouble sleeping; Trouble sleep; So weak/has weakness so bad she cannot even hardly get out of bed and go to the bathroom; She is also having chills; Super fast heart rate around 150; Has a low grade fever; Her blood pressure was still high; This is a spontaneous report from a contactable consumer (patient). A 64-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Formulation: Solution for injection, Lot number: EN6201), via an unspecified route of administration on 17Mar2021 as a dose 1, single for COVID-19 immunization. The patient's medical history included high blood pressure. The patient's concomitant medications included lisinopril 5 mg, taken for blood pressure. It was reported that, received call from consumer regarding the Pfizer COVID vaccine. Stated that, she received it a week ago at the health department. She did not even feel it. Enquired, the caller was a 64-year-old female who received her first dose of the Pfizer BioNTech COVID-19 vaccine a week ago and reported that, she did great with it and experienced no side effects. She then stated that, for the last two days she has been so weak to the point where she can hardly get out of bed and also reported having chills. Stated that, these symptoms started on day 6, yesterday, after receiving the vaccine and stated that, today they are worse. Stated that, she does not think she has been exposed to COVID-19. The health department scheduled her to come back 30 days later. The caller stated that, she has been scheduled to have her second dose of the Pfizer BioNTech COVID-19 vaccine in 30 days instead of the recommended 21 days. She was being told Pfizer second dose was 21 days apart. When she called them, they said everyone that got the Pfizer shot was being scheduled that day and did not have a reason. She looked it up and it says there was a 4 day window after 21 days. She wanted to know whether it was normal to have symptoms a week after getting the vaccine and if 30 days in between doses was ok. She was concerned about how long this side effects may last and the vaccine may not be effective if given this late. Response included that, what are the results of the Phase 1 study, to inform caller that instances of fever, fatigue and chills generally lasted about 1-2 days. The caller was referred to healthcare professional for further guidance. The caller would like to know whether there have been any reports of death with the Pfizer BioNTech COVID-19 vaccine and whether the second dose of the Pfizer BioNTech COVID-19 vaccine was going to be worse than the first as far as side effects after. Response included that, let caller know that overall the percentage of side effects reported was greater after the second dose than the first dose. Specifically referenced the percentages for fever and chills. Also let caller know to keep in mind that everyone's body is different and may have a different reaction to the vaccine. The consumer stated that, she had her second Covid vaccination Pfizer 6 days ago in her left shoulder and her left shoulder was really hurting it, it's radiating into her scapula and having trouble sleeping on 22Mar2021 and she just wondered whether there was something she could or should do about that. Stated that, her left shoulder was really hurting it's radiating into her scapula and having trouble sleeping was reported as worsened. The consumer was informed about Pfizer Medical information department and was provided with the number. Stated that, there were 2 lot numbers because she had 2 vaccines, sure the first one was EN6201, next one was EN6207. Stated that, on Monday, right after she got the vaccination it seems it has gotten worse. The consumer stated that, she had been taking Ibuprofen. She then stated that, for the last two days she has been so weak to the point where she can hardly get out of bed and also reported having chills. Stated that, these symptoms started on day 6, yesterday, after receiving the vaccine and stated that, today they are worse. Stated that, she does not think she has been exposed to COVID-19. The caller stated that, she also has had chills and bad aches, for which they scanned her head to toe for that one, but nothing showed up. Stated that, she has had a low grade fever and she was not a high blood pressure or tachycardic girl and this didn't happen until after she got the vaccine. Stated that, she was told a lot of people were coming in the week after the shot, but she doesn't know whether they have reported anything. Stated that, she feels like she was going to die, this was awful. Stated that, she would like to know whether there have been any new reports or was she the only one in the world having this reaction. Stated that, she would also wanted to know how long it will last, since her doctors don't know what to do for her. The description of the product complaint included that, the caller doesn't have a report reference to provide from previous report. Pfizer COVID-19 vaccine: The caller stated that, her handwritten vaccine card did not provide NDC/EXP. Stated that, it has Pfizer and LOT and next appointment date of 15Apr2021. The consumer stated that, she called the other day and thought she started a report and thought someone would have sent her an email or something. Stated that, tomorrow would be 14 days after her first vaccine dose, which on day 6 she was severely weak and couldn't move or get out of bed hardly. Stated that, she was really weak and has a lot of fatigue and a super fast heart rate around 150 on an unspecified date in Mar2021 which she couldn't make stop even if she laid down. Stated that, she went to the doctor who said side effects are the day after she had it, she would feel like she had the flu, which she told them she talked to Pfizer and there are other side effects reported. Stated that, she had all kinds of lab work done and all of them were great, everything was good. Stated that, she thought hopefully it would wear off in a day or two, but four days later it was not better. She went to the doctor on Thursday and yesterday she was not better, her blood pressure was still high. Stated that, when she went to the doctor it was 170/110 and her heart rate will not get below 120. Stated that, she was so weak and fatigued, she has a low grade fever, this has been going on 4-5 days and she knows it was the vaccine, they tested for everything, she was careful and she doesn't go around people. The reporter considered the events as non-serious. On an unspecified date, the patient underwent lab tests and procedures which included Blood Pressure, resulted as 170/110, heart rate, resulted as below 120 and heart rate, resulted as around 150, super fast heart rate and all kinds of lab work done, resulted as normal. The outcome of the events was unknown.  No follow-up attempts are needed. No further information is expected.; Sender's Comments: Linked Report(s) : US-PFIZER INC-2021344672 similar report from same reporter