Age: 74.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Pyrexia, SARS-CoV-2 antibody test, Vaccination site pain
Clinical narrative: COVID-19; Was very sick; I had a reaction to the Moderna; Produced antibodies after the vaccine; Soreness in her arm after the Moderna Vaccines; Felt like she was coming down with something; She had severe muscle aches worse than when she had COVID 19; She had a fever; This spontaneous case was reported by a patient and describes the occurrence of IMMUNISATION REACTION (Felt like she was coming down with something), COVID-19 (COVID-19), ILLNESS (Was very sick), IMMUNISATION REACTION (I had a reaction to the Moderna) and IMMUNISATION REACTION (Produced antibodies after the vaccine) in a 74-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 013L20A and 016M20A) for COVID-19 prophylaxis. The occurrence of additional non-serious events is detailed below.    Co-suspect product included non-company product TOZINAMERAN (PFIZER BIONTECH COVID-19 VACCINE) for an unknown indication.    Caller stated that her family has a lot of autoimmune issues, Lupus, Rheumatoid Arthritis, and her daughter has Celiac disease.  The patient's past medical history included COVID-19 from March 2020 to April 2020, Cancer and Fever (4 times in her life). Concurrent medical conditions included Systemic lupus erythematosus (States she was formally diagnosed a few years ago, but her rheumatologist says she has had it her whole life.) and Immunocompromised (my immune system goes up and down up and down).   On 20-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 17-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 21-Jul-2021 at 10:00 AM, the patient received third dose of TOZINAMERAN (PFIZER BIONTECH COVID-19 VACCINE) (unknown route) 1 dosage form. On 19-Feb-2021, the patient experienced MYALGIA (She had severe muscle aches worse than when she had COVID 19) and PYREXIA (She had a fever). On 22-Jul-2021, the patient experienced IMMUNISATION REACTION (Felt like she was coming down with something). On an unknown date, the patient experienced COVID-19 (COVID-19), ILLNESS (Was very sick), IMMUNISATION REACTION (I had a reaction to the Moderna), IMMUNISATION REACTION (Produced antibodies after the vaccine) and VACCINATION SITE PAIN (Soreness in her arm after the Moderna Vaccines). The patient was treated with PARACETAMOL (TYLENOL 8 HOUR) for Fever, at an unspecified dose and frequency. On 20-Feb-2021, MYALGIA (She had severe muscle aches worse than when she had COVID 19) and PYREXIA (She had a fever) had resolved. On 23-Jul-2021, IMMUNISATION REACTION (Felt like she was coming down with something) had resolved. At the time of the report, COVID-19 (COVID-19), ILLNESS (Was very sick), IMMUNISATION REACTION (I had a reaction to the Moderna) and IMMUNISATION REACTION (Produced antibodies after the vaccine) outcome was unknown and VACCINATION SITE PAIN (Soreness in her arm after the Moderna Vaccines) had resolved. Not Provided    DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): In 2021, Body temperature: 97.3 degree Celsius and 100 degree Celsius. On 15-Jul-2021, SARS-CoV-2 antibody test: (Negative) Negative antibody test after both doses of Moderna Covid Vaccine.     For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   This case was identified as part of a retrospective clean-up activity where certain emails received in the Moderna mailbox were missed to be booked in.  The caller was calling to get information about the Pfizer COVID Vaccine and the protection it provides. The caller initially received the Moderna COVID Vaccine series. The patient was tested for antibodies due to her history with Lupus and her antibody test was negative. The caller also mentioned a reaction to the Moderna vaccine. The caller had now been started on Pfizer COVID Vaccine series and received her first dose on 21-Jul-2021 at 10: 00. The caller stated that her reaction to the Moderna vaccine was after the second dose. Patient stated she had symptoms that showed she was producing antibodies. Caller stated that she had Lupus and says that her Lupus attacks the immune system specifically and goes up and down. The caller stated she thinks that she produced antibodies after the vaccine, but that they are gone because of her Lupus. The caller said that prior to her second dose of the Moderna vaccine she had only had a fever 4 times in her life. The second day after the second Moderna vaccine she had severe muscle aches that were worse than when she had COVID-19. A few hours later on the same day patient had a fever. Patient stated that her normal temperature was 97.3 degrees. When her fever got up to 100 degrees patient took a Tylenol and then she was fine. Patient Stated the next day she was completely fine. Patient stated that yesterday, the second day after her Pfizer COVID Vaccine, patient felt like she was coming down with something. Patient stated that it is gone, and she was fine today. The caller stated she does not have an alternative phone number to provide. Patient had  no email address provided of the HCP. Patient stated that her Primary Care Provider does not know the whole story. She stated he ordered the antibody test and then he went on vacation.Caller stated that she called her rheumatologist. Caller clarified that she decided to get the Pfizer vaccine on her own. The caller contacted her primary care provider who agreed to do the antibody test. Stated she then contacted her rheumatologist. Her rheumatologist told her that has not put any recommendations in writing to tell doctors what to do related to booster shots. The caller stated that she then called office and left a message with the secretary saying if no one called her back she would contact the news media. Within a few hours someone called her back and told her to put her concerns in writing via email. The Caller stated that her rheumatologist was not against her getting the Pfizer vaccine series after getting the Moderna vaccine series. He just told the caller that he could not tell her to go and do it. Caller states that she did it because she was not going to let her life go down the tubes. Later in the call, the caller consents to her primary care provider being contacted with further questions about this report. She asked if he cannot be contacted for at least a week since he doesn't know any of this information yet about her getting the Pfizer Vaccine. Patient said that she almost died from COVID-19. Caller mentioned soreness in her arm after the Moderna vaccines; states only that it wasn't bad, says it was like normal little soreness after a shot. Caller stated that it took forever for her to get the Moderna Vaccine because it took forever to get vaccines in her area. Caller stated that she had COVID 19 for 29 days. Says that her doctor wanted her hospitalized, but the emergency room doctor did not want her to come to the hospital. The emergency room doctor thought that due to her being sick and having a low white blood cell count she would catch something at the hospital like pneumonia or bronchitis. Stated she went through her COVID 19 at home. She would get up every day at midnight and start calling places looking for someone who had the vaccines available. Stated the process is much better now than it was back then. Caller said that her COVID symptoms started in Mar 2020. Said that COVID came to where she lives around 11 Mar 2020; she estimated she got her first symptoms around 15 Mar 2020. Says it lasted into April. Caller denied any other medications, medical conditions, or treatments relevant to report.   This case was linked to MOD-2021-626149 (Patient Link).