Age: 29.0
Sex: M
Vaccine: COVID19
Symptoms: Antinuclear antibody, Antinuclear antibody positive, Blood test, Feeling abnormal, Impaired quality of life
Clinical narrative: the only thing that came up was a positive Fluorescent Antinuclear antibody or an ANA test.; affecting the patient's ability to do his daily routine; feeling pretty bad; recurrent myalgia; feeling like having a fever; muscle issues; post-vaccination syndrome; This is a spontaneous report received from contactable reporter(s) (Physician) from medical information team. The reporter is the parent.  A 29-year-old male patient received BNT162b2 (BNT162B2), on 22Apr2021 as dose 2, single (Lot number: ER8735) at the age of 29 years, in left arm for covid-19 immunisation. The patient had no relevant medical history. The patient's concomitant medications were not reported. Vaccination history included: BNT162b2 (DOSE 1, SINGLE, Lot: ER8737, Exp: Unknown, Site: Injection, he think his left arm), administration date: 01Apr2021, when the patient was 29-year-old, for COVID-19 immunization. The following information was reported: IMPAIRED QUALITY OF LIFE (non-serious) with onset 22Apr2021, outcome "not recovered", described as "affecting the patient's ability to do his daily routine"; PYREXIA (medically significant) with onset 22Apr2021, outcome "not recovered", described as "feeling like having a fever"; FEELING ABNORMAL (medically significant) with onset 22Apr2021, outcome "not recovered", described as "feeling pretty bad"; MUSCLE DISORDER (medically significant) with onset 22Apr2021, outcome "not recovered", described as "muscle issues"; POST VACCINATION SYNDROME (non-serious) with onset 22Apr2021, outcome "not recovered", described as "post-vaccination syndrome"; MYALGIA (medically significant) with onset 22Apr2021, outcome "not recovered", described as "recurrent myalgia"; ANTINUCLEAR ANTIBODY POSITIVE (non-serious) with onset 25Jan2023, outcome "not recovered", described as "the only thing that came up was a positive Fluorescent Antinuclear antibody or an ANA test.". The patient underwent the following laboratory tests and procedures: Antinuclear antibody: (25Jan2023) positive, notes: came up was a positive  Fluorescent Antinuclear antibody or an ANA test; Blood test: (unspecified date) Unknown results, notes: at least 6 times since he stared experiencing these symptoms; (unspecified date) Unknown results, notes: at least 6 times since he stared experiencing these symptoms; (unspecified date) Unknown results, notes: at least 6 times since he stared experiencing these symptoms; (unspecified date) Unknown results, notes: at least 6 times since he stared experiencing these symptoms; (unspecified date) Unknown results, notes: at least 6 times since he stared experiencing these symptoms; (unspecified date) Unknown results, notes: at least 6 times since he stared experiencing these symptoms. Therapeutic measures were taken as a result of myalgia.  Clinical course: Reporter stated that my son was still having symptoms from the second injection of the primary series of the Pfizer COVID-19 vaccine that will not go away. It was enquired that further information on side effects not going away, like a post-vaccination syndrome. This physician reported his son, who was the patient, experienced side effects after the second injection of the primary series for the Pfizer monovalent COVID-19 vaccine. The side effects were further described as feeling pretty bad, recurrent myalgia, and feeling like having a fever. These side effects had not gone away. The physician did stated his son had received two injections of the Pfizer COVID-19 monovalent for the primary series and had also received a booster dose of the bivalent. It was enquired that specialist there reporter could speak further with that could offer recommendations on what tests to perform due to his side effects, like might be the spike protein in his blood and possible treatment recommendations. He gone to saw a rheumatologist today and reporter would like to obtain information like this before his visit. Other conditions was no. Other products was no. Reporter stated that the Pfizer COVID-19 Vaccine and reported a adverse event for the second dose of the primary series. After the second dose of the primary series, the patient reported feeling pretty bad, recurrent myalgia, muscle issues, and feeling like he had a fever. These symptoms were still going on since the 2nd dose. The patient has had a booster dose since then. The patient's symptoms started right after the second vaccine which was 22Apr2021. The aches and fatigue are the same, but he was not running a fever. The patient had a pretty significant early 2 day response that put him down for a week at home. Seriousness: It was serious in the fact that it was affecting the patient's ability to do his daily routine. His symptoms come on about once every 2 weeks and last 3-4 days, he said that the frequency had  been progressive. It is enough to put the patient in bed and he does not want to get out. The patient is a world class athlete and this has been difficult for his son because he is used to fitness everyday. The patient had been to the doctor several times and the only thing that came up was a positive  Fluorescent Antinuclear antibody or an ANA test. He had this 2 weeks ago on 25Jan2023. The patient has had blood work at least 6 times since he stared experiencing these symptoms. 2nd dose: Time was unknown, but thinks it was mid morning. The patient took third dose of Moderna on 03Mar2022. He did not had as violent a reaction as he did to the Pfizer vaccine 2nd dose. Clarified that he had fatigue and aches after the Moderna dose, but it was not as bad as what with the second Pfizer dose. The aches were all over and in the muscles. Prior Vaccinations (within 4 weeks) was none. Concomitant Drugs was not applicable. Patient's medical history (including any illness at time of vaccination) was none. Family medical history relevant to adverse events was none.   Source of assessment: Primary Source Reporter, Method of assessment: Result of Assessment: Yes, Drug-reaction(s)/Event(s) Matrix. Source of assessment: Primary Source Reporter Method of assessment. Result of Assessment: Yes. Drug-reaction(s) / Event(s) Matrix.; Sender's Comments: Based on the available information in the case, the causal association between the events myalgia,feeling abnormal,Pyrexia,muscle disorder  and the suspect drug  cannot be excluded.  The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to regulatory authorities, Ethics Committees, and Investigators, as appropriate