Age: 79.0
Sex: F
Vaccine: COVID19
Symptoms: Atrial fibrillation, Bell's palsy, COVID-19, Cardiac failure, Fluid retention
Clinical narrative: Water retention; Platelet disorder; COVID-19; Platelet count abnormal; Atrial fibrillation; Bell's palsy; Shingles; Heart failure; This spontaneous case was reported by a consumer and describes the occurrence of COVID-19 (COVID-19), HERPES ZOSTER (Shingles), FLUID RETENTION (Water retention), CARDIAC FAILURE (Heart failure), PLATELET DISORDER (Platelet disorder), PLATELET COUNT ABNORMAL (Platelet count abnormal), ATRIAL FIBRILLATION (Atrial fibrillation) and BELL'S PALSY (Bell's palsy) in a 79-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 010M20A. and 024M20A.) for COVID-19 vaccination.    Co-suspect product included non-company product ADALIMUMAB (HUMIRA) solution for injection for Rheumatoid arthritis.    Concurrent medical conditions included Pollen allergy (NON TOBACCO USER) and Sinus disorder. Concomitant products included OMEPRAZOLE (PRILOSEC [OMEPRAZOLE]) for Acid reflux (esophageal), CALCIUM for Vitamin B1 supplementation, VITAMIN D3, CYANOCOBALAMIN (VITAMIN B12 [CYANOCOBALAMIN]) and IRON for Vitamin supplementation, LEVOTHYROXINE SODIUM (SYNTHROID), ALENDRONATE SODIUM (FOSAMAX), HYDROCHLOROTHIAZIDE, TRIAMTERENE (DYAZIDE), FOLIC ACID, METOPROLOL TARTRATE (LOPRESSOR), PRAMIPEXOLE, POTASSIUM, OXYBUTYNIN and METHOTREXATE for an unknown indication.   In 2016, the patient started ADALIMUMAB (HUMIRA) (Subcutaneous) at an unspecified dose. On 11-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 11-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. In 2021, the patient experienced CARDIAC FAILURE (Heart failure) (seriousness criteria hospitalization and medically significant). In September 2021, the patient experienced HERPES ZOSTER (Shingles) (seriousness criterion hospitalization). In October 2021, the patient experienced PLATELET COUNT ABNORMAL (Platelet count abnormal) (seriousness criterion hospitalization), ATRIAL FIBRILLATION (Atrial fibrillation) (seriousness criteria hospitalization and medically significant) and BELL'S PALSY (Bell's palsy) (seriousness criteria hospitalization and medically significant). On 27-Nov-2021, the patient experienced COVID-19 (COVID-19) (seriousness criterion hospitalization). On an unknown date, the patient experienced FLUID RETENTION (Water retention) (seriousness criterion hospitalization) and PLATELET DISORDER (Platelet disorder) (seriousness criterion hospitalization). At the time of the report, COVID-19 (COVID-19) and HERPES ZOSTER (Shingles) had not resolved, FLUID RETENTION (Water retention) outcome was unknown and CARDIAC FAILURE (Heart failure), PLATELET DISORDER (Platelet disorder), PLATELET COUNT ABNORMAL (Platelet count abnormal), ATRIAL FIBRILLATION (Atrial fibrillation) and BELL'S PALSY (Bell's palsy) was resolving.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): In October 2021, Platelet count: Platelet at 29. On 27-Nov-2021, SARS-CoV-2 test: Positive.         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.  On 11 Feb 2021 and on 11 Mar 2021, the patient received first and second Moderna shot respectively. Ever since  she got the Moderna shot, she had gotten lots of things. This all happened on 02 Sep 2021. Everything was on  her right side. Her heart physician thought it came from the shots. In Sep 2021, she was diagnosed with  shingles and only had it on the one side of right side of head, neck, in mouth, on right shoulder and went down the side of head and the left side of mouth was pulled of her face. This was all happened after she was  diagnosed with shingles. It was driving her crazy and was itchy. She was collecting water weight. She was  hospitalized twice. The first hospitalization was because of shingles in Sep 2021. It started out with having trouble breathing. She was in the hospital for 15 days for heart failure. In hospital, they said she had atrial fibrillation, heart failure and shingles. For atrial fibrillation, she had been taking unknown medicine to make it stayed in rhythm. She had her checked two times but it did not work. She was sent to a rehab center and just came home on 02 Oct 2021. Then second day, she got diagnosed with bell's palsy but it was getting much  better. As of 05 Oct 2021, she was still recovering. In Oct 2021, physician said that her platelets were at 29. So, he ordered her to go to the emergency room but came to find out her platelets were ok. This happened before whereas they said her platelets were getting clogged. The second time she was admitted because of covid 19 positive in Nov 2021. The physician was recommending to put her in rehabilitation. She received antibodies. infusion and could not get the covid 19 booster for 90 days. She had unknown nasal swab test to confirm covid  19 positive in Nov 2021. Her husband also tested positive for covid 19 and was quarantined.  Company comment: This spontaneous case concerns a 79-years-old female patient of with no medical history reported, who experienced the unexpected serious (hospitalization and medically significant) events of COVID-19 (AESI), Herpes zoster, Fluid retention, Cardiac failure, Platelet disorder, Bell's palsy, Platelet count abnormal and Atrial fibrillation (AESI) that occurred in context to the third dose mRNA-1273 vaccination. Latency cannot be assessed since event onset dates was not disclosed. It was reported that approximately 6 months later to vaccination she was diagnosed with shingles. She was collecting water weight. She was hospitalized twice. The first hospitalization was because of shingles and later 15 days for heart failure. For atrial fibrillation, she had been taking unknown medicine to make it stayed in rhythm. She was sent to a rehab center and next day, she got diagnosed with bell's palsy which was recovering. It was physician who said that her platelets were at 29. So, he ordered her to go to the emergency room but came to find out her platelets were ok. This happened before whereas they said her platelets were getting clogged. The second time she was admitted because of covid 19 SARS-CoV-2 test was Positive in Nov 2021. The physician was recommending putting her in rehabilitation. She received antibodies. The treatment details were not provided, and the event outcome was not recovered for COVID -19, herpes zoster, unknown for Cardiac failure and fluid retention and recovering for other events. The benefit-risk relationship of mRNA-1273 Vaccine is not affected by this report. Event seriousness assessed as per medical judgement.; Sender's Comments: This spontaneous case concerns a 79-years-old female patient of with no medical history reported, who experienced the unexpected serious (hospitalization and medically significant) events of COVID-19 (AESI), Herpes zoster, Fluid retention, Cardiac failure, Platelet disorder, Bell's palsy, Platelet count abnormal and Atrial fibrillation (AESI) that occurred in context to the third dose mRNA-1273 vaccination. Latency cannot be assessed since event onset dates was not disclosed. It was reported that approximately 6 months later to vaccination she was diagnosed with shingles. She was collecting water weight. She was hospitalized twice. The first hospitalization was because of shingles and later 15 days for heart failure. For atrial fibrillation, she had been taking unknown medicine to make it stayed in rhythm. She was sent to a rehab center and next day, she got diagnosed with bell's palsy which was recovering. It was physician who said that her platelets were at 29. So, he ordered her to go to the emergency room but came to find out her platelets were ok. This happened before whereas they said her platelets were getting clogged. The second time she was admitted because of covid 19 SARS-CoV-2 test was Positive in Nov 2021. The physician was recommending putting her in rehabilitation. She received antibodies. The treatment details were not provided, and the event outcome was not recovered for COVID -19, herpes zoster, unknown for Cardiac failure and fluid retention and recovering for other events.The benefit-risk relationship of mRNA-1273 Vaccine is not affected by this report. Event seriousness assessed as per medical judgement.