Age: 82.0
Sex: F
Vaccine: COVID19, COVID19, COVID19
Symptoms: Fatigue, Feeling abnormal, Immunisation reaction, Inappropriate schedule of product administration, Papule
Clinical narrative: bad reaction to the first two/bad reaction was that obviously after she had her vaccine doses; feeling kind of lousy; The rash was red and a little bit flat then also had little bumps around her, a simple type thing; The rash was red and a little bit flat then also had little bumps around her, a simple type thing; Rash/broke out into a big rash all around midrif that itched and itched for about ten days; washed out; second dose of Moderna COVID-19 vaccine was given to her two or three months later after her first dose; This spontaneous case was reported by a patient and describes the occurrence of IMMUNISATION REACTION (bad reaction to the first two/bad reaction was that obviously after she had her vaccine doses), FEELING ABNORMAL (feeling kind of lousy), PAPULE (The rash was red and a little bit flat then also had little bumps around her, a simple type thing), RASH ERYTHEMATOUS (The rash was red and a little bit flat then also had little bumps around her, a simple type thing) and RASH PRURITIC (Rash/broke out into a big rash all around midrif that itched and itched for about ten days) in an 82-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) 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.    The patient's past medical history included Stent placement (2009 had her other stent put in.) in 2007. Concurrent medical conditions included Coronary artery disease since 2007 and High cholesterol. Concomitant products included CLOPIDOGREL BISULFATE (PLAVIX) from 2007 to an unknown date, ASPIRIN [ACETYLSALICYLIC ACID] from 2007 to an unknown date and EZETIMIBE (ZETIA) from 2009 to an unknown date for Coronary artery disease, PRAVASTATIN from 2009 to an unknown date for High cholesterol, METOPROLOL SUCCINATE (TOPROL) from 2009 to an unknown date for an unknown indication.   In 2020, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. In 2021, the patient received third dose of TOZINAMERAN (PFIZER BIONTECH COVID-19 VACCINE) (unknown route) 1 dosage form. On an unknown date, the patient experienced IMMUNISATION REACTION (bad reaction to the first two/bad reaction was that obviously after she had her vaccine doses), FEELING ABNORMAL (feeling kind of lousy), PAPULE (The rash was red and a little bit flat then also had little bumps around her, a simple type thing), RASH ERYTHEMATOUS (The rash was red and a little bit flat then also had little bumps around her, a simple type thing), RASH PRURITIC (Rash/broke out into a big rash all around midrif that itched and itched for about ten days), FATIGUE (washed out) and INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (second dose of Moderna COVID-19 vaccine was given to her two or three months later after her first dose). At the time of the report, IMMUNISATION REACTION (bad reaction to the first two/bad reaction was that obviously after she had her vaccine doses), FEELING ABNORMAL (feeling kind of lousy), PAPULE (The rash was red and a little bit flat then also had little bumps around her, a simple type thing), RASH ERYTHEMATOUS (The rash was red and a little bit flat then also had little bumps around her, a simple type thing), FATIGUE (washed out) and INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (second dose of Moderna COVID-19 vaccine was given to her two or three months later after her first dose) outcome was unknown and RASH PRURITIC (Rash/broke out into a big rash all around midrif that itched and itched for about ten days) had resolved.            Moderna COVID-19 vaccine and Pfizer COVID-19 vaccine reported with unknown expiry date. She had the exact same reaction to Pfizer booster so she wondered if she should go ahead get the Omicron or another booster. She did no treatment of the rash and finally it went away by itself. She probably started taking Zetia in 2007 or 2009, probably 2009 when she had her other stent put in. Her cholesterol was high, so she takes it for her cholesterol as well to keep it under control.  Treatment medications were not reported.   This case was linked to MOD-2022-649145 (Patient Link).