Sex: F
Vaccine: FLUX, VARZOS
Symptoms: Injection site pain, Malaise, Pain in extremity, Pyrexia
Clinical narrative: patient has gotten sick; febrile; Initial information received on 11-Aug-2021 regarding an unsolicited valid non-serious case from a consumer/non health care professional in courtesy.  This case involved a 62 years old female patient who had gotten sick (illness) and febrile (pyrexia), after receiving INFLUENZA VACCINE and VARICELLA ZOSTER VACCINE (shingles).  The patient's past medical history included immunocompromised and multiple allergies.  It was unknown if the patient had any concomitant disease or risk factor.  The patient's past medical treatment(s), vaccination(s), concomitant medication(s) and family history were not provided.  On an unknown date, the patient received a dose of suspect INFLUENZA VACCINE produced by unknown manufacturer (lot number and expiration date not reported) and a dose of suspect VARICELLA ZOSTER VACCINE not produced by Sanofi Pasteur (lot number and expiration date not reported) via unknown route in an unknown administration site for prophylactic vaccination.  On an unknown date, the patient had gotten sick (illness) and febrile (pyrexia) [unknown latency] following the administration of vaccines.  It was reported as "Transfer not offered as agent did not remember until after call. Call received as transfer from agent, Caller states she is a recipient of the Pfizer BioNTech Covid-19 (coronavirus disease) Vaccine, along with her 85 year old father and 80 year old mother. Caller states her father had his second dose of the vaccine in February. Caller states her sister got the Moderna Covid-19 Vaccine and it "made her sick." Caller states she is 62 years old, immunocompromised, has multiple allergies, and has gotten sick with the shingles vaccine, and febrile with the influenza vaccine. Caller states she received her first dose of the Pfizer BioNTech Covid-19 Vaccine on 29-Mar-2021 and her second dose on 20-Apr-2021. Caller states she started noticing injection site "achiness" in May that has not gone away. Caller states she did not have any allergic reaction to the vaccine, but her left arm/hand will ache sometimes. Caller states she has neck and back problems, but she knows the achiness is not from that because she feels it where she received her injection. Caller states, "I can use it, but it still aches where I got the shot." Caller asking if there is a booster dose, and if not, when there will be, and if it will be the same as the other two doses of the Pfizer BioNTech Covid-19 Vaccine. Caller asking if the booster will cover Covid-19 variants, especially the Delta Variant. Caller states she will be first in line for the booster if and when it is available. Caller asking if current doses of the Pfizer BioNTech Covid-19 Vaccine are effective against circulating Covid-19 variants, especially the Delta Variant. Caller asking how long protection from the first two doses of the Pfizer BioNTech Covid-19 Vaccine lasts. Caller asking how long her side effect of injection site pain will last. Caller asking if someone is exposed to the Delta Variant or any other Covid-19 variant, how long will it take before that person would test positive for Covid- 19. Caller asking if breakthrough infections with variants have occurred after being fully vaccinated with the Pfizer BioNTech Covid-19 Vaccine. Caller states, "I appreciate your time. I know I have been on the phone a long time with you." Response: Spoke Booster Dose (v1.0). "The Pfizer-BioNTech COVID-19 Vaccine is administered as a 2-dose series, 3 weeks apart, into the muscle. If you receive one dose of the Pfizer-BioNTech COVID-19 Vaccine, you should receive a second dose of this same vaccine 3 weeks later to complete the vaccination series. In an ongoing clinical trial, the Pfizer-BioNTech COVID-19 Vaccine has been shown to prevent COVID-19 following 2 doses given 3 weeks apart. The duration of protection against COVID-19 is currently unknown. At this time, a booster dose (an extra or third dose after receiving the two-dose series) is not recommended or authorized. If you have any further questions on the use of Pfizer- BioNTech COVID-19 Vaccine, ask your healthcare professional." Provided caller with website:  to stay up to date with Pfizer's Covid-19 resources and information. Request Name: Question: Caller asking how long protection from the first two doses of the Pfizer BioNTech Covid-19 Vaccine lasts. Response: Spoke: how long will I be protected (v4.0). "In an ongoing clinical trial, the Pfizer- BioNTech COVID-19 Vaccine has been shown to prevent COVID-19 following 2 doses given 21 days apart. The duration of protection (how long you will be protected against COVID-19) is currently unknown." Spoke from FAQ (frequently asked questionnaire)-Efficacy against COVID-19 up to 6 months following second dose (version 1.0). On April 1, 2021, Pfizer and BioNTech announced an updated topline analysis up to 6 months following second dose of Landmark COVID-19 Vaccine Study. "Analysis of 927 confirmed symptomatic cases of COVID-19 demonstrates Pfizer-BioNTech COVID-19 Vaccine (BNT162b2) is effective with 91.3 percent vaccine efficacy observed against COVID-19, measured seven days through up to 6 months after the second dose. Vaccine safety now evaluated in more than 44,000 participants 16 years of age and older, with more than 12,000 vaccinated participants having at least six months follow-up after their second dose." Referred to HCP. Request Name: REQProduct: PFIZER-BIONTECH COVID-19 VACCINE Question: Caller states, "I appreciate your time. I know I have been on the phone a long time with you." Response: "Thank you for calling Pfizer Medical Information. I appreciate your time as well." Offered survey at end of call.  Request Name: REQProduct: PFIZER-BIONTECH COVID-19 VACCINE Question: Caller asking if current doses of the Pfizer BioNTech Covid-19 Vaccine are effective against circulating Covid-19 variants, especially the Delta Variant. Response: Spoke from FAQ_COVID-19 Vaccine- Will the vaccine protect against variants especially the delta variant? (v1.0) "The Pfizer- BioNTech COVID-19 Vaccine may not protect everyone. (2) Disease Control states that information about the characteristics of these variants is rapidly emerging. Scientists are working to learn more about how easily they spread, whether they could cause more severe illness, and whether currently authorized vaccines will protect people against them. (1) Disease control is monitoring multiple variants; currently there are four notable variants in this country:(1) B.1.1.7 (Alpha): This variant was first detected in this country in December 2020. It was initially detected in another country. B.1.351 (Beta): This variant was first detected in the this country at the end of January 2021. It was initially detected in another country in December 2020. P.1 (Gamma): This variant was first detected in this country in January 2021. P.1 was initially identified in travelers from another country, who were tested during routine screening at an airport in another country, in early January. B.1.617.2 (Delta): This variant was first detected in March 2021. It was initially identified in India in December 2020. So far, studies suggest that the current authorized vaccines work on the circulating variants. Scientists will continue to study these and other variants. Please call your vaccination provider or your healthcare provider if you have any questions about this topic or the safety or efficacy of Pfizer-BioNTech COVID-19 Vaccine. " Request Name: REQ- Product: PFIZERBIONTECH COVID-19 VACCINE Question: Caller asking how long her side effect of injection site pain will last. Response: Spoke from CONS -How long side effects last (v3.0). Informed caller that Pfizer cannot determine exactly how long her side effects will last. "These may not be all the possible side effects of the Pfizer-BioNTech COVID-19 Vaccine. Serious and unexpected side effects may occur. Pfizer-BioNTech COVID-19 Vaccine is still being studied in clinical trials. The safety evaluation of participants is still ongoing. Among the Pfizer-BioNTech COVID-19 Vaccine recipients, mild-to-moderate pain at the injection site within 7 days after an injection was the most commonly reported local reaction, with less than 1% of participants across all age groups reporting severe pain. In general, local side effects; the ones you get on the arm where you got the shot (such as injection site redness and injection site swelling) were mostly mildto- moderate in severity and resolved within 1 to 2 days. Call the vaccination provider or your healthcare provider if you have any side effects that bother you or do not go away." Request Name: REQProduct: PFIZER-BIONTECH COVID-19 VACCINE Question: Caller asking if someone is exposed to the Delta Variant or any other Covid-19 variant, how long will it take before that person would test positive for Covid-19. Caller asking if breakthrough infections with variants have occurred after being fully vaccinated with the Pfizer BioNTech Covid-19 Vaccine. Response: Referred caller to disease control and HCP. Informed caller that Pfizer does not perform Covid-19 testing and does not have data to speak from in regards to testing positive for Covid-19 and its variants. Referred caller to disease control website for control telephone number.   It was unknown if the patient experienced any additional symptoms/events.   It was unknown if there were laboratory data/results available.  It was not reported if the patient received a corrective treatment.  At time of reporting, the outcome was unknown for both the reported event. There will be no information on batch number for this case.