Age: 85.0
Sex: F
Vaccine: COVID19
Symptoms: Blood pressure measurement, Dehydration, Hypotension, Inappropriate schedule of product administration, Parkinson's disease
Clinical narrative: WORSENS PARKINSON'S SYMPTOMS; First dose on 06-JAN-2021 and second dose on 05-MAR-2021; DEHYDRATION; URINARY TRACT INFECTION; LOW BLOOD PRESSURE; This spontaneous case was reported by a consumer and describes the occurrence of PARKINSON'S DISEASE (WORSENS PARKINSON'S SYMPTOMS) in an 85-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 028L20A, 011J20A and 051F21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.    Co-suspect products included non-company products CARBIDOPA, LEVODOPA (DUOPA) for Parkinson's disease and MORPHINE for an unknown indication.    The patient was a non-tobacco user and has abstained from alcohol.  The patient's past medical history included Spasms, Back surgery and Surgery. Previously administered products included for Product used for unknown indication: SULFAMETHOXAZOLE and CODEINE PHOSPHATE. Past adverse reactions to the above products included Drug allergy with SULFAMETHOXAZOLE; and Vomiting with CODEINE PHOSPHATE. Concurrent medical conditions included Parkinson's disease, Drug allergy and Drug allergy. Concomitant products included DROXIDOPA (NORTHERA), NAPROXEN SODIUM (ALEVE), ARIPIPRAZOLE, METHOCARBAMOL, CANNABIS SATIVA (CBD COMPLEX), CALCIUM CARBONATE, COLECALCIFEROL (CALTRATE + D [CALCIUM CARBONATE;COLECALCIFEROL]), QUETIAPINE FUMARATE, BETAXOLOL HYDROCHLORIDE (BETOPTIC), TRAVOPROST (TRAVATAN), MIRTAZAPINE, CARBIDOPA, LEVODOPA (CARBIDOPA/LEVODOPA), LEVOTHYROXINE SODIUM, LORAZEPAM, PROBIOTIC 10 [BIFIDOBACTERIUM BIFIDUM;BIFIDOBACTERIUM LACTIS;LACTOBACILLUS ACIDOPHILUS;LACTOBACILLUS BREVIS;LACTOBACILLUS BULGARICUS;LACTOBACILLUS CASEI;LACTOBACILLUS PARACASEI;LACTOBACILLUS PLANTARUM;LACTOBACILLUS RHAMNOSUS;LACTOBACILLUS SALIVARIUS], CARBIDOPA and ASCORBIC ACID, COPPER GLUCONATE, FISH OIL, TOCOPHEROL, XANTOFYL, ZEAXANTHIN, ZINC OXIDE (OCUVITE ADULT 50+ [ASCORBIC ACID;COPPER GLUCONATE;FISH OIL;TOCOPHEROL;XANTOFYL;ZEAXANTHIN;ZINC OXIDE]) for an unknown indication.   On 28-Jul-2020, the patient CARBIDOPA, LEVODOPA (DUOPA) (unknown route) dosage was changed to 100 milliliter. On 18-Aug-2020, CARBIDOPA, LEVODOPA (DUOPA) (unknown route) dosage was changed to 100 milliliter. On 06-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 05-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 11-Sep-2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On an unknown date, the patient started CARBIDOPA, LEVODOPA (DUOPA) (unknown route) 1 dosage form and MORPHINE (unknown route) at an unspecified dose. On an unknown date, the patient experienced PARKINSON'S DISEASE (WORSENS PARKINSON'S SYMPTOMS) (seriousness criteria disability and medically significant), INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (First dose on 06-JAN-2021 and second dose on 05-MAR-2021), DEHYDRATION (DEHYDRATION), URINARY TRACT INFECTION (URINARY TRACT INFECTION) and HYPOTENSION (LOW BLOOD PRESSURE). The patient was treated with PARACETAMOL (TYLENOL) at a dose of 1 dosage form. At the time of the report, PARKINSON'S DISEASE (WORSENS PARKINSON'S SYMPTOMS), INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (First dose on 06-JAN-2021 and second dose on 05-MAR-2021), URINARY TRACT INFECTION (URINARY TRACT INFECTION) and HYPOTENSION (LOW BLOOD PRESSURE) outcome was unknown and DEHYDRATION (DEHYDRATION) had not resolved.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, Blood pressure measurement: Low.         It was unknown if patient was enrolled in a COVID-19 Vaccine Trial. Concomitant drug included PROBIOTIC 10B.  Duopa was administered through Percutaneous (J-tube) route.  It was reported that, Pump Serial Number: 566056 and Gel Cassette Lot number: 1152316. Primary reporter did not have the lot number information, because the packaging was discarded for second regimen.  It was reported that, 24 HOURS DUOPA  INFUSION, PATIENTS TUBING WAS STARTING TO SEPERATE AT VALVE/Y CONNECTOR CAME LOOSE/INNER TUBE AND OUTER TUBE KIND OF SEPARATED/CONNECTION OF Y CAME UNSCREWED A LITTLE BIT AND UNCLAMPED OUTER TUBE, PATIENT COULD NOT FEED SELF OR PULL PANTS DOWN, URINARY TRACT INFECTION, LEG WEAKNESS, LOW BLOOD PRESSURE, INTESTINAL TUBE DISLOCATIONM and SHAKY. On unknown dates, the patient experienced DEBILITATED, PATIENT WAS BEDRIDDEN, MENTALLY AND PHYSICALLY UNCAPABLE, MENTAL STATUS DOWNHILL, CONFUSION, MEMORY ISSUES, ANXIETY, NEED ASSISTANCE WALKING (LEG WEAKNESS), SHAKY all are the symptoms of  PARKINSON'S.  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. Company comment-This spontaneous case concerns a 85-year-old female patient, with relevant medical history of Parkinson's disease on DUOPA reported, who experienced the unexpected serious (medically significant/Disability) event of Parkinson's disease (reported as WORSENS PARKINSON'S SYMPTOMS) on an unknown date after receiving the 2nd dose of mRNA-1273 vaccine. Additionally , Inappropriate schedule of product administration was noted as patient received 1st and 2nd doses of mRNA-1273 vaccine approximately 2 months apart, and 3rd dose was given 6 months later, which is not in accordance with the recommended vaccine interval. Patient also had confusion, memory issues, anxiety, weakness in legs, needed assistance to walk. She was bedridden, physically and mentally uncapable for day today activities. No further info   This case was linked to MOD-2021-623469 (Patient Link).   Most recent FOLLOW-UP information incorporated above includes: On 28-Dec-2021: Significant follow-up appended, seriousness updated. Patient's medical history, concomitant medications, Co-suspect indication and doses were updated. Worsens Parkinson's symptoms, dehydration, urinary tract infection and low blood pressure  were added as events. Treatment drug was added. Reporter causality was updated.  Company comment: This spontaneous case concerns a 85-year-old female patient, with relevant medical history of Parkinson's disease on DUOPA reported, who experienced the unexpected serious (medically significant/Disability) event of Parkinson's disease (reported as WORSENS PARKINSON'S SYMPTOMS) on an unknown date after receiving the 2nd dose of mRNA-1273 vaccine. Additionally , Inappropriate schedule of product administration was noted as patient received 1st and 2nd doses of mRNA-1273 vaccine approximately 2 months apart, and 3rd dose was given 6 months later, which is not in accordance with the recommended vaccine interval. Patient also had confusion, memory issues, anxiety, weakness in legs, needed assistance to walk. She was bedridden, physically and mentally uncapable for day today activities. No further information on detailed clinical course, investigations, treatment of the events was available in the report.  Outcome of the event was not known at the time of report. Relevant medical history remains a confounder and Concomitant drug QUETIAPINE FUMARATE can be considered as contributory to the event. The benefit-risk relationship of mRNA-1273 is not affected by this report.; Sender's Comments: This spontaneous case concerns a 85-year-old female patient, with relevant medical history of Parkinson's disease on DUOPA reported, who experienced the unexpected serious (medically significant/Disability) event of Parkinson's disease (reported as WORSENS PARKINSON'S SYMPTOMS) on an unknown date after receiving the 2nd dose of mRNA-1273 vaccine. Additionally , Inappropriate schedule of product administration was noted as patient received 1st and 2nd doses of mRNA-1273 vaccine approximately 2 months apart, and 3rd dose was given 6 months later, which is not in accordance with the recommended vaccine interval. Patient also had confusion, memory issues, anxiety, weakness in legs, needed assistance to walk. She was bedridden, physically and mentally uncapable for day today activities. No further information on detailed clinical course, investigations, treatment of the events was available in the report.  Outcome of the event was not known at the time of report. Relevant medical history remains a confounder and Concomitant drug QUETIAPINE FUMARATE can be considered as contributory to the event. The benefit-risk relationship of mRNA-1273 is not affected by this report.