Age: 73.0
Sex: F
Vaccine: COVID19
Symptoms: Diarrhoea, Hypersensitivity, Interchange of vaccine products, Pneumonia, Pyrexia
Clinical narrative: Acute renal failure; Pneumonia; Anemia; Diarrhea; Allergic reaction; Temperature of 103 F for quite a while; Previously received 3 doses of Pfizer Covid19 vaccine; Previously received 3 doses of Pfizer Covid19 vaccine; This spontaneous case was reported by a patient family member or friend and describes the occurrence of ACUTE KIDNEY INJURY (Acute renal failure), PNEUMONIA (Pneumonia), ANAEMIA (Anemia), DIARRHOEA (Diarrhea), HYPERSENSITIVITY (Allergic reaction) and PYREXIA (Temperature of 103 F for quite a while) in a 73-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 044C22A) for COVID-19 prophylaxis. The occurrence of additional non-serious events is detailed below.     The patient's past medical history included COVID-19 (Patient fight it on her one, No hospitalization due to COVID-19) on 03-Apr-2022. Previously administered products included for Product used for unknown indication: Pfizer (1st dose in right arm) in April 2021, Pfizer (2nd dose in right arm) in April 2021 and Pfizer (1st booster in right arm). Past adverse reactions to the above products included No adverse event with Pfizer, Pfizer and Pfizer. Concurrent medical conditions included Asthma, Acid reflux (oesophageal), Disability (Developmental Disability), Arthritis and Penicillin allergy (Rash). Concomitant products included OMEPRAZOLE (PROTONIX [OMEPRAZOLE]) for Acid reflux (oesophageal), LEVOTHYROXINE SODIUM (SYNTHROID) and IBUPROFEN (ADVIL [IBUPROFEN]) for an unknown indication.    On 29-Jul-2022, the patient received fourth dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. In 2022, the patient experienced DIARRHOEA (Diarrhea) (seriousness criterion hospitalization), HYPERSENSITIVITY (Allergic reaction) (seriousness criterion hospitalization) and PYREXIA (Temperature of 103 F for quite a while) (seriousness criterion hospitalization). In July 2022, the patient experienced ACUTE KIDNEY INJURY (Acute renal failure) (seriousness criteria hospitalization and medically significant), PNEUMONIA (Pneumonia) (seriousness criteria hospitalization and medically significant) and ANAEMIA (Anemia) (seriousness criterion hospitalization). On 29-Jul-2022, the patient experienced INTERCHANGE OF VACCINE PRODUCTS (Previously received 3 doses of Pfizer Covid19 vaccine) and COVID-19 IMMUNISATION (Previously received 3 doses of Pfizer Covid19 vaccine). The patient was hospitalized on 01-Aug-2022 due to ACUTE KIDNEY INJURY, ANAEMIA and PNEUMONIA. At the time of the report, ACUTE KIDNEY INJURY (Acute renal failure), PNEUMONIA (Pneumonia), ANAEMIA (Anemia), DIARRHOEA (Diarrhea), HYPERSENSITIVITY (Allergic reaction), PYREXIA (Temperature of 103 F for quite a while), INTERCHANGE OF VACCINE PRODUCTS (Previously received 3 doses of Pfizer Covid19 vaccine) and COVID-19 IMMUNISATION (Previously received 3 doses of Pfizer Covid19 vaccine) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 03-Apr-2022, SARS-CoV-2 test: (Positive) Positive. In 2022, Biopsy kidney: Patient had an allergic reaction. In 2022, Body temperature: 103 F.     For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   The patient also had COVID-19 in January. No other vaccines given within 1 month prior to Moderna COVID-19 vaccine. Concomitant products also included Breo inhaler once a day for Asthma. Reporter stated that the patient been in the hospital since 01-Aug-2022. After the 2nd booster patient started receiving hemodialysis due to acute renal failure, pneumonia, and anemia. Patient had a temperature of 103 F for quite a while. Patient had diarrhea (lose bowel movement). When they did a biopsy of her kidney, patient had an allergic reaction. Company Comment: This spontaneous case concerns a 73-year-old female patient, with relevant medical history of penicillin allergy and arthritis, with concomitant use of ibuprofen, who experienced unexpected, serious (hospitalization) events of AESI acute kidney injury (also medically significant), pneumonia (also medically significant), anemia, diarrhea, hypersensitivity, and pyrexia, after receiving a dose of mRNA-1273 (fourth dose in a Covid19 vaccination schedule).  She was hospitalized 3 days post-vaccination.  She had a fever and diarrhea for quite a while, then started receiving hemodialysis for acute renal failure, pneumonia, and anemia.  A kidney biopsy was done, after which she had an allergic reaction.  The result of the kidney biopsy was not reported.  Further details on clinical course of events, other relevant diagnostic evaluation, and treatment were not reported.  Outcome was unknown.  The medical history of penicillin allergy could be a confounding factor for the hypersensitivity.  The patient's age, medical history of arthritis and use of ibuprofen, and diarrhea could be contributory factors for acute kidney injury.  Additionally, the patient previously received 3 doses of different Covid19 vaccine Pfizer - as primary series given around 1 year and 3 months prior and first booster given on an unknown date.  The benefit risk relationship of mRNA-1273 is not affected by this report.; Sender's Comments: This spontaneous case concerns a 73-year-old female patient, with relevant medical history of penicillin allergy and arthritis, with concomitant use of ibuprofen, who experienced unexpected, serious (hospitalization) events of AESI acute kidney injury (also medically significant), pneumonia (also medically significant), anemia, diarrhea, hypersensitivity, and pyrexia, after receiving a dose of mRNA-1273 (fourth dose in a Covid19 vaccination schedule).  She was hospitalized 3 days post-vaccination.  She had a fever and diarrhea for quite a while, then started receiving hemodialysis for acute renal failure, pneumonia, and anemia.  A kidney biopsy was done, after which she had an allergic reaction.  The result of the kidney biopsy was not reported.  Further details on clinical course of events, other relevant diagnostic evaluation, and treatment were not reported.  Outcome was unknown.  The medical history of penicillin allergy could be a confounding factor for the hypersensitivity.  The patient's age, medical history of arthritis and use of ibuprofen, and diarrhea could be contributory factors for acute kidney injury.  Additionally, the patient previously received 3 doses of different Covid19 vaccine Pfizer - as primary series given around 1 year and 3 months prior and first booster given on an unknown date.  The benefit risk relationship of mRNA-1273 is not affected by this report.