Sex: F
Vaccine: COVID19
Symptoms: Body temperature, Pain in extremity, Pyrexia, SARS-CoV-2 test
Clinical narrative: had a 99.2 pyretic; sore arm; This is a spontaneous report from a contactable consumer. This consumer (mother) reported a female patient (her daughter) of an unspecified age received bnt162b2 (BNT162B2, Formulation: Solution for injection, Batch/Lot number was not reported), dose 1 via an unspecified route of administration on Jul2021 (age at the time of vaccination was not provided) as DOSE 1, SINGLE for covid-19 immunisation. The patient's medical history and concomitant medications were not reported. The reporter (mother) stated that the patient (her daughter) had a 99.2 pyretic and had sore arm on an unspecified date. The patient underwent lab tests and procedures which included body temperature: 99.2 (unspecified unit) on an unspecified date and sars-cov-2 test, which was found to be negative on 26Jul2021. The outcome of the events was reported as unknown. Additionally, the caller had concerns which were discussed as; The caller wants to know if you stretch the interval between the two doses longer than the three weeks will there be a problem. She was responded as, the second dose of Pfizer-BioNTech and Moderna vaccines should be administered as close to the recommended interval as possible, but if it was not possible to give the second dose at 3 weeks and a delay cannot be avoided, it might be given up to 6 weeks (42 days) after the first dose. The caller was transferred by staff at Support. The caller received her first dose of the Pfizer COVID-19 vaccine and the next day her husband had COVID. She stated that five days after receiving the vaccine the caller tested positive for COVID as well. The caller was now recovering. The caller was due to get her second dose on 09Aug2021 and was looking for guidance on receiving the second dose, and was she going to be immune to COVID, and did she need to start the process over again or was she fine with just getting the second dose. The caller stated that her actual question was this, prior to 19Jul2021, her husband went back to work, almost 99 percent sure that Wednesday he got exposed to someone at work, who had no symptoms. She stated that the person was unvaccinated, and her husband was unvaccinated, her husband had a mask, and the person had no mask. He believes that was the person who gave it to him because after he had a meeting with that person in his office., three hours later he heard that person coughing, and he literally knew it was the bad news. From that point on everything that went on was textbook. Five days later on 19Jul2021, we were all still good showed no symptoms whatsoever, she and her daughter, and her husband. Her daughter and herself had an appointment to get the first shot of the Pfizer COVID-19 vaccine at 1 O'clock. That same day her husband went to work, he had a dentist appointment, he got home and was fine. She states that at 7 O'clock it hit him like a brick. He was not feeling good, he had a 101.7 fever, high blood pressure which he didn't run, and the doctor told him to go to the emergency room. They did the rapid test which came back as negative but they also sent out a PCR and sent him home, by Tuesday morning the PCR test became positive for COVID. So they have been in quarantine since 20Jul2021. She stated that her and her daughter and her husband have been separated and wear masks when they can because they thought that they had COVID. They were still treating each other to be safe but her husband had been locked in his bedroom since the 20Jul2021, he had not come out. The reporter stated that she and her daughter were fine, but stated her daughter (the patient) had a 99.2 pyretic little thing going on, and she was thinking oh great she has COVID even though she had no symptoms until Saturday 24Jul2021 it hit the caller that evening. She stated she got a few symptoms nothing drastic. She stated she got a cold pretty much. She stated that today was the first day that she was fever free. She stated that she can pretty much state that she would be fine in the next couple of days. She stated she contacted her doctor and asked them what they were doing, and on 26Jul2021 he sent the caller and her daughter to do a PCR test. She said that her daughter had no symptoms, she did not have any fevers for three days now, her symptoms were not showing. She states that they did the PCR test, and the callers came back as positive and hers came back as negative. How hers was negative she states she did not know, but whatever was happening with her she did not get COVID. So she was now separated in another room because she needs to protect her daughter because she was the only one who didn't get sick. So the doctor said to keep the 09Aug2021 appointment, the callers daughter should repeat the PCR test as close to the appointment as possible, if she was negative she can take the vaccine, and if she was positive call them and let them know and they would tell her what to do.  The caller states that the doctor told her that she does not need to take another PCR test which she thought was strange, but the doctor said that she would be shedding the virus for the next three months and if you continue to do the PCR test it would continue to become positive even though you were no longer contagious but there were particles still there that would show up on the PCR test as positive. He told the caller if she was fever free for 24-48 hours and showing no symptoms then she can go an take the vaccine on 09Aug2021. She stated that she knows people who have been treated with plasma and clonal cocktails they should wait three months before they take the vaccine. She states that she did not have any of that she got over it by herself. She stated that someone in her family who had COVID after doing what she was told to do go the second dose of the vaccine and she was sick as a dog. She stated that she was really worried it is going to happen to her. She stated she needed advice, and asked what she can do, or to postpone for her and her daughter for another week. She stated that her daughter needed to be vaccinated for college before 06Sep2021 and we need to make sure she was fully vaccinated with the two-week time afterwards. She stated that you read me out of the paper but now she wants the agent to tell her without the paper as nurse, what you read was what she read. She didn't want that. She stated she wanted a professional person to tell her. She stated that she was assuming that she has already been exposed to COVID prior to taking the vaccine because her husband had that contact with that person in his office on Wednesday. He showed symptoms on Tuesday, could he already been exposed or not, she did not know. She stated that the vaccine didn't do much to them except her daughter had a sore arm right away, and had a sore arm the next day other than that they were fine, but now but with the second one she knew you read that it was not going to do anything but she did know that there were people who have been sick, how do she know for sure, and can Pfizer be stretched longer than the 28 days or 21 days like they do in country because she heard that even given 28 days apart because the longer it was given apart the longer the vaccine has a chance to start working. Rather than just doing it 21 days apart. Caller wanted to know what the recommendation about all of this was. Caller stated in her case what was the recommendation for her to do just to take it. She stated that different doctors would give different information. Her husband's doctor tells her one thing and the doctor told her another thing that was why she was calling the manufacturer the people who develop the vaccine, and she was trying to get more broader information. She stated the doctors don't know they really don't know. They just go cause by cause and were just shooting darts in the dark. She asked if she should reach out to the CDC and who else the health department and who else would be able to assist her with this. She asked if Pfizer provided a statement on the need for a booster dose (3rd dose) and was Pfizer investigating the need for a booster dose. The caller stated that we were getting the vaccine now, and there was a report that has come out that Pfizer's efficacy has literally diminished to 84 percent or 60 percent because a lot of people got the vaccine in December and January and are reaching the 6-month time frame are we going to be protected fully for the next 6 months or was everyone going to need to get a booster right away. She was answered as, response: As part of Pfizer's and BioNTech's continued efforts to stay ahead of the virus causing COVID-19 and circulating mutations, the companies provided an update on booster dosing on 09Jul2021. Please note that the use of a 3rd or booster dose was not recommended or authorized and Pfizer does not suggest the use of the vaccine in any manner other than as described in the (if country) authorized EUA Prescribing Information (if withheld) authorized product monograph. Initial data from the ongoing study of booster doses demonstrated a consistent tolerability profile and high neutralization titers against the wild-type virus (the naturally occurring non-mutated virus) and the Beta variant. It was thought that the effects seen against the Beta variant might also be seen in the Delta variant. We were doing studies to confirm this. We expect to publish the data soon in a peer-reviewed journal and submit to regulatory authorities like the FDA in the coming weeks. Note to frontline: This FAQ should only be used if an HCP or non-HCP specifically asks about the Pfizer statement on booster doses. For HCPs with general inquiries about booster doses, please refer to the article (Booster Dose). Non-HCPs should be referred to their HCP for further discussion. References: 08Jul2021. The caller wanted to know if there was any information on people who have COVID, how long they keep their antibodies and do they really need the second dose. She had the first dose and got antibodies from the virus would she really need the second dose. She was answered as given the following information from the attached document: A review of the Prescribing Information for Pfizer COVID-19 vaccine failed to find any information regarding patient's antibodies from COVID and need for the second shot. Please consult with your doctor or health care provider for further guidance, as your doctor/healthcare provider was the most familiar with her medical condition. The caller stated that she heard Pfizer will be approved by 01Jan2022, FDA approved was that true She states that she heard it was going to be before January. Given with response: The Pfizer-BioNTech COVID-19 Vaccine was currently available in the country under an Emergency Use Authorization (EUA) granted by the Food and Drug Administration (FDA) on 11Dec2020. On 16Jul2021, Pfizer and BioNTech announced that the FDA granted Priority Review designation for the License Application (LA) for the Pfizer-BioNTech COVID-19 Vaccine to prevent COVID-19 in individuals 16 years of age and older. The goal date for a decision by the FDA is in Jan2022. The application includes clinical data from the pivotal Phase 3 clinical trial of the vaccine, where the vaccine's efficacy and safety profile were observed up to six months after the second dose. On 10May2021, the FDA expanded the EUA of the Pfizer-BioNTech COVID-19 Vaccine to include individuals 12 through 15 years of age. The companies intend to submit a supplemental LA to support licensure of the vaccine in this age group once the required data six months after the second vaccine dose are available. Pfizer does not recommend the use of the vaccine in any manner inconsistent with the EUA Prescribing Information.  [Frontline: for non-HCPs please state We refer you to your healthcare provider to discuss this topic]