Sex: F
Vaccine: COVID19
Symptoms: COVID-19, Pain in extremity, SARS-CoV-2 test
Clinical narrative: tested positive for COVID; sore arm; This is a spontaneous report from Pfizer. This consumer (patient) reported for a female patient of an unspecified age received bnt162b2 (BNT162B2, Formulation: Solution for injection), dose 1 via an unspecified route of administration on an unspecified date as DOSE 1, SINGLE for covid-19 immunisation. The patient's medical history and concomitant medications were not reported. The patient tested positive for covid and sore arm on an unspecified date. Patient received her first does and the next day her husband tested positive for Covid-19. Five days after receiving her vaccine she tested positive as well. She is recovering and is scheduled to receive her second dose August 9th. She wants to know is there any guidance of her receiving the second dose and if she needs to get revaccinated. The patient underwent lab tests and procedures which included sars-cov-2 test: positive on an unspecified date. Outcome of the event tested positive for covid was recovering and sore arm was unknown. Product Quality Complaint: Reporter Subtype: Patient, PQC Present: No, AE Present: Yes, CEP/PSP: 159558(Pfizer COVID-19 Vaccine Call Center)  PQC Details:  Product: PFIZER-BIONTECH COVID-19 VACCINE Question: Caller wants to know if you stretch the interval between the two doses longer than than the three weeks will there be a problem. Response: Caller was provided the following information from the attached document: o The second dose of Pfizer-BioNTech and Moderna vaccines should be administered as close to the recommended interval as possible, o But if it is not possible to give the second dose at 3-weeks and a delay cannot be avoided, it may be given up to 6 weeks (42 days) after the first dose. 3  Product: PFIZER-BIONTECH COVID-19 VACCINE Question: Caller is a consumer who was transferred by COVAX US Support; CEP 159558. Transfer agent states that the caller has received her first dose of the Pfizer COVID-19 vaccine and the next day her husband had COVID. She states that five days after receiving the vaccine the caller tested positive for COVID as well. The caller is now recovering.  The caller is due to get her second dose on 9 AUG 2021 and is looking for guidance on receiving the second dose, and is she going to be immune to COVID, and does she need to start the process over again or is she fine with just getting the second dose? The caller states that her actual question is this, prior to 19 JUL 2021, Her husband went back to work, almost 99 percent sure that Wednesday he got exposed to someone at work, who had no symptoms. She states that the person was unvaccinated and her husband was unvaccinated. She states that her husband had a mask and the person had no mask. He believes that is 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 text book. Five days later on 19 JUL 2021, we were all still good showed no symptoms what so ever, me, my daughter, and my 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 hits him like a brick. He was not feeling good, he had a 101.7 fever, high blood pressure which he doesn'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 20 JUL 2021. She states 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 20 JUL 2021, he hasn't come out. She states that she and her daughter were fine, but states her daughter had a 99.2 pyretic little thing going on, and she is thinking oh great she has COVID even though she had no symptoms until Saturday 24 JUL 2021 it hit the caller that evening. She states she got a few symptoms nothing drastic. She states she got a cold pretty much. She states that today is the first day that she is fever free. She states that she can pretty much state that she will be fine in the next couple of days. She states she contacted her doctor and asked them what are they doing, and on 26 JUL 2021 he sent the caller and her daughter to do a PCR test. She says that her daughter has no symptoms, she doesn't have any fevers for three days now, her symptoms are 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 does not know, but what ever is happening with her she did not get COVID. So she is now separated in another room because she needs to protect her daughter because she is the only one who didn't get sick. So the doctor said to keep the 9 AUG 2021 appointment, the callers daughter should repeat the PCR test as close to the appointment as possible, if she is negative she can take the vaccine, and if she is positive call them and let them know and they will 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 will be shedding the virus for the next three months and if you continue to do the PCR test it will continue to become positive even though you are no longer contagious but there  are particles still there that will show up on the PCR test as positive. He told the caller if she is fever free for 24-48 hours and showing no symptoms then she can go an take the vaccine on 9 AUG 2021. She states 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 her self. She states 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 states that she is really worried it is going to happen to her. She states she needs advice, what does she do? Does she postpone for her and her daughter for another week? She states that her daughter needs to be vaccinated for college before 6 SEP 2021 and we need to make sure she is fully vaccinated with the two week time afterwards. What is your advise knowing what I am telling you. She states 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 is what I read. She doesn't want that. She states she wants a professional person to tell her. She states that she is 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 doesn't know. She states that the vaccine didn't do much to them except her daughter had a sore arm right away, and the caller had a sore arm the next day other than that they were fine, but now but with the second one I know you read that its not going to do anything but I do know that there are people who have been sick, how do I know for sure, and can Pfizer be stretched longer than the 28 days or 21 days like they do in location because she heard that even given 28 days apart because the longer it is given apart the longer the vaccine has a chance to start working. Rather than just doing it 21 days apart. Caller wants to know what is the recommendation about all of this. Caller states in her case what is the recommendation for her to do just to take it? She states that different doctors will give different information. Her husbands doctor tells her one thing and my doctor tells me another thing that is why she is calling the manufacturer the people who develop the vaccine, and she is trying to get more broader information. She state the doctors don't know they really don't know. They just go cause by cause and are just shooting darts in the dark. Should she reach out to the CDC, who else the health department? Who else would be able to assist her with this?  DSU: E-transmitting AE details Response: Caller was provided the disclaimer.  Request Name: REQ-426684 Product: PFIZER-BIONTECH COVID-19 VACCINE Question: Has Pfizer provided a statement on the need for a booster dose (3rd dose)? Is Pfizer investigating the need for a booster dose? Caller states that we are getting the vaccine now, and there's 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 is everyone going to need to get a booster right away. 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 July 9, 2021. Please note that the use of a 3rd or booster dose is not recommended or authorized and Pfizer does not suggest the use of the vaccine in any manner other than as described in the authorized EUA Prescribing Information  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 is thought that the effects seen against the Beta variant may also be seen in the Delta variant. We are 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 SRD titled "Administration of More Than a 2-Dose Series (Booster Dose)". Non-HCPs should be referred to their HCP for further discussion. References: 08Jul2021 Press Statement ?with held EUA PI  and PM  Request Name: REQ- Product: PFIZER-BIONTECH COVID-19 VACCINE Question: Caller wants to know if there is any information on people who have COVID, how long they keep their antibodies? and do they really need the second dose? that is my question, I had the first dose and got antibodies from the virus do I really need the second dose? Response: Caller was 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 is the most familiar with your medical condition.  Request Name: REQ- Product: PFIZER-BIONTECH COVID-19 VACCINE Question: Caller states that she heard Pfizer will be approved by 1Jan2022, FDA approved is that true? She states that she heard it was going to be before January. Response: The Pfizer-BioNTech COVID-19 Vaccine is currently available in the U.S. 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 (BLA) 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 May 10, 2021, 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 BLA 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'] Reference: Pfizer Press Statement. Agency GRANTS PRIORITY REVIEW FOR THE LICENSE APPLICATION FOR PFIZER-BIONTECH COVID-19 VACCINE. July 16, 2021. Available at: with held.  Medical Information (MI): Were any medical questions addressed by this program forwarded/referred to Medical Information? Yes  Follow up attempts are needed, Information on lot/batch number has been requested.