Age: 59.0
Sex: F
Vaccine: COVID19
Symptoms: Abdominal pain upper, Back pain, Fatigue, Headache, Lethargy
Clinical narrative: She found out at the hospital that she had polynephritis; She had pain in her back and stomach; She had pain in her back; By Sunday morning, she had fatigue; She felt lethargic; Same day after receiving 2nd dose, she had body aches; She had sore throat/ She had persistent sore throat; She had headaches; This spontaneous case was reported by a consumer and describes the occurrence of PYELONEPHRITIS (She found out at the hospital that she had polynephritis), ABDOMINAL PAIN UPPER (She had pain in her back and stomach), BACK PAIN (She had pain in her back), FATIGUE (By Sunday morning, she had fatigue), HEADACHE (She had headaches), LETHARGY (She felt lethargic), PAIN (Same day after receiving 2nd dose, she had body aches) and OROPHARYNGEAL PAIN (She had sore throat/ She had persistent sore throat) in a 59-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 001C21A) for COVID-19 vaccination.     No medical history was provided by the reporter.  Concomitant products included CARVEDILOL (COREG) and CETIRIZINE HYDROCHLORIDE (ZYRTEC [CETIRIZINE HYDROCHLORIDE]) for an unknown indication.    On 20-May-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 20-May-2021, the patient experienced HEADACHE (She had headaches) (seriousness criterion hospitalization), PAIN (Same day after receiving 2nd dose, she had body aches) (seriousness criterion hospitalization) and OROPHARYNGEAL PAIN (She had sore throat/ She had persistent sore throat) (seriousness criterion hospitalization). On 23-May-2021, the patient experienced PYELONEPHRITIS (She found out at the hospital that she had polynephritis) (seriousness criteria hospitalization and medically significant), ABDOMINAL PAIN UPPER (She had pain in her back and stomach) (seriousness criterion hospitalization), BACK PAIN (She had pain in her back) (seriousness criterion hospitalization), FATIGUE (By Sunday morning, she had fatigue) (seriousness criterion hospitalization) and LETHARGY (She felt lethargic) (seriousness criterion hospitalization). The patient was hospitalized on 23-May-2021 due to ABDOMINAL PAIN UPPER, BACK PAIN, FATIGUE, HEADACHE, LETHARGY, OROPHARYNGEAL PAIN, PAIN and PYELONEPHRITIS. The patient was treated with PARACETAMOL (TYLENOL) for Adverse event, at an unspecified dose and frequency. At the time of the report, PYELONEPHRITIS (She found out at the hospital that she had polynephritis), ABDOMINAL PAIN UPPER (She had pain in her back and stomach), BACK PAIN (She had pain in her back), FATIGUE (By Sunday morning, she had fatigue), HEADACHE (She had headaches), LETHARGY (She felt lethargic) and PAIN (Same day after receiving 2nd dose, she had body aches) outcome was unknown and OROPHARYNGEAL PAIN (She had sore throat/ She had persistent sore throat) had not resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   Treatment medication included Tylenol  Company Comment: This case concerns a  59  years-old, female subject without significant clinical history, who experienced the unexpected events of PYELONEPHRITIS, ABDOMINAL PAIN UPPER, BACK PAIN, FATIGUE, HEADACHE, LETHARGY, PAIN and OROPHARYNGEAL PAIN. The event occurred between the first and the third day after the most recent (2nd) dose of [Spikevax]. The rechallenge is not applicable. The events were considered related to the study drug per the reporter's assessment. The benefit-risk relationship of the vaccine is not affected by this report.   This case was linked to MOD-2021-328985 (Patient Link).; Sender's Comments: This case concerns a  59  years-old, female subject without significant clinical history, who experienced the unexpected events of PYELONEPHRITIS, ABDOMINAL PAIN UPPER, BACK PAIN, FATIGUE, HEADACHE, LETHARGY, PAIN and OROPHARYNGEAL PAIN. The event occurred between the first and the third day after the most recent (2nd) dose of [Spikevax].   The rechallenge is not applicable The events were considered related to the study drug per the reporter's assessment The benefit-risk relationship of the vaccine is not affected by this report