Sex: F
Vaccine: COVID19
Symptoms: Antibody test, Headache, Illness, Pain in extremity, Pyrexia
Clinical narrative: After the 1st dose, she said she had fever; headache; sore arm; feel sick; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) from medical information team for a Pfizer sponsored program. The reporter is the patient.  A 53 year-old female patient received bnt162b2 (BNT162B2), administration date Apr2021 (Batch/Lot number: unknown) as dose 1, single for covid-19 immunisation. Relevant medical history included: "she is allergic to 40 different medications" (unspecified if ongoing); "Immunocompromised" (unspecified if ongoing), notes: She said she is severely immunocompromised. Concomitant medication(s) included: HUMERA taken for neoplasm; METHOTREXATE SODIUM; PREDNISONE. Past drug history included: Naproxen sodium, reaction(s): "pestle blisters all over her body"; Naproxen sodium, reaction(s): "flushing". The following information was reported: PYREXIA (non-serious) with onset 2021, outcome "unknown", described as "After the 1st dose, she said she had fever"; HEADACHE (non-serious) with onset 2021, outcome "unknown", described as "headache"; PAIN IN EXTREMITY (non-serious) with onset 2021, outcome "unknown", described as "sore arm"; ILLNESS (non-serious) with onset 2021, outcome "unknown", described as "feel sick". Relevant laboratory tests and procedures are available in the appropriate section.  Additional information: It was reported that the patient received the 1st dose of the Pfizer-BioNTech Covid-19 Vaccine on Apr2021, the 2nd dose on May2021, and the booster dose on Aug2021. After the 1st dose, she said she had fever, headache, and sore arm. After the 2nd dose, she was in bed for a day, and had more body aches. Then after the booster dose, she had a more robust reaction which kept her in bed for 4 days. She said she was severely immunocompromised. She said she was on Humera which was a medication that uses a tumor necrotizing factor. She said she was also on Methotrexate, and then after 3 months was put on Paltz. She said she took the initial 2 shots, but it made her feel sick so she did not take the 2nd months of treatment. She did not tolerate and get along with the medication very well. She also mentioned that while she was on Humera and Paltz, she was given Prednisone. She also mentioned that she was allergic to 40 different medications. She said she cannot take antibiotics or over-the-counter medications. She said she cannot even take Naproxen sodium because she gets "pestle blisters" all over her body, and flushing. She said that on 20Feb2022, it will already be 6 months from her 1st booster dose. She said that if the foreign study holds true, then she was looking on a declining immunity of the vaccine, and will most likely have a decreased immunity. She said she was part of the 1st group of people who first received the booster dose. She said there were no guidelines anywhere for people like her who can't get sick because they "would be shooting in the dark with monoclonal antibodies. She said she did not know if she was going to have sufficient antibodies left to fight the delta, omicron, or other future variants 6 months after her 1st booster dose. She said she was worried that "normal" people who've received the booster dose might have a declining immunity after 6 months, and may possibly give her one of the variants. A booster dose was an additional dose of a vaccine that was given at least 6 months after completing the primary series because the immune response to the primary series wanes over time. An additional (third dose) of the vaccine was given at least 4 weeks after the second dose to people who are determined to have certain kinds of immunocompromise and did not get an adequate immune response to the primary series. The CDC stated that antibody testing was not recommended to determine if a person was immune to SARS-CoV-2 [the virus that causes COVID-19] following COVID-19 vaccination because the usefulness of these tests in vaccinated people had not been established.In addition, antibody tests currently authorized under an EUA are not authorized to determine immune responses in vaccinated people. The patient was immuno-compromised and her immune system was weak. She received her two doses of the Pfizer Covid-19 shots. She also received the Pfizer Covid-19 booster shot recently. Response: Responded from the attached. "The CDC states that antibody testing is not recommended to determine if a person is immune to SARS-CoV-2 [the virus that causes COVID-19] following COVID-19 vaccination because the usefulness of these tests in vaccinated people has not been established. In addition, antibody tests currently authorized under an EUA are not authorized to determine immune responses in vaccinated people. Caller (Name) was asking for the 2nd booster dose because she already received the 1st booster dose in august. She mentioned that she is immunocompromised due to her medication, and get symptomatic for the Omicron variant. She was not in a vaccine trial. Agent stated Caller got her 4th shot on 16Jan2022. Agent states Caller reports she was hungry, and felt like she wanted to sleep. She was immunocompromised and has 4 autoimmune disorders, and on 16Jan2022, received her fourth Covid shot, and clarifies as second booster shot. Caller states she had arranged with her doctors to get a second booster shot because of the lack of significant response to her prior shots. Caller clarifies she is not in a vaccine trial. Caller states because of the recent spike of Covid cases her doctors wanted her to get a second booster. Caller states she will complete a report if it is used for research and development. Caller states she would like to be transferred to the research and development department to see if they have any information on the vaccine with people that are immunocompromised either genetically or because of medications. Caller clarifies she has had no adverse events. Caller states that aside from a headache, fever, and not wanting to get out of bed, she had no events to report. Caller states she would like to speak to the people at Pfizer who are doing the research. Caller states that aside from a fever, headache, body aches, and staying in bed, she is feeling fine now. Caller states that it is important for the research and development department to know that for immunocompromised patients, the vaccine is proven to be safe and provokes a more robust reaction with the second booster shot, than the original two vaccines and booster. Caller states that the second booster provides a more robust reaction and better production of antibodies than the original two shots and booster. Caller states she is calling because people in her category get overlooked. Caller declines to complete safety report, after being probed multiple times. Caller states she has called Pfizer research and development before, and was instructed to scan for trials to see if she would fit into one of the catagories, to get a second booster. Caller states her and her two doctors felt she was in imminent peril and wanted her to get a second booster. Caller states she finally got a second booster. Caller states she felt bad for 4 days. Caller clarifies that she does not want to report her event. Caller states as someone who is immunocompromised, and is on a tumor necrotizing factor drug, Methotrexate, and Prednisone for the last 6 months for her autoimmune disorders, she wants Pfizer to know that she is having a more robust reaction to her Covid booster, than her prior 3 shots. Caller does not provide product information for her other drugs. Caller clarifies that she has called Pfizer previously. Caller states that she would like to speak to someone in research and development.  Description of Product Complaint: Description of complaint: Caller states she is calling about the Pfizer Covid 19 vaccine, booster. Caller states she is immunocompromised and has 4 autoimmune disorders, and on 16Jan2022, received her fourth Covid shot, and clarifies as second booster shot. Caller states she had arranged with her doctors to get a second booster shot because of the lack of significant response to her prior shots. Caller states that the second booster provides a more robust reaction and better production of antibodies than the original two shots and booster. Caller states she is calling because people in her category get overlooked. Caller declines to complete safety report, after being probed multiple times.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.