Age: 72.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Interchange of vaccine products, Parkinson's disease, Stoma site infection, Vaccination site pain, Vaccination site swelling
Clinical narrative: PARKINSONS DISEASE PROGRESSION; Esophageal reflux; FREQUENT FALLS; HIT HEAD; Light headedness; Patient had received 2 doses of mRNA-1273 vaccine prior to Pfizer COVID-19 vaccination; Patient had received 2 doses of mRNA-1273 vaccine prior to Pfizer COVID-19 vaccination; PAIN AT INJECTION SITE; SWELLING AT INJECTION SITE; Stoma site infection; STOMA INFECTION; This spontaneous case was reported by a consumer and describes the occurrence of PARKINSON'S DISEASE (PARKINSONS DISEASE PROGRESSION) in a 72-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 012M2O) 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 an unknown indication, TELMISARTAN for an unknown indication and TOZINAMERAN (PFIZER BIONTECH COVID-19 VACCINE) for COVID-19 vaccination.    The patient's past medical history included Rash, Fall (FREQUENT FALLS) and Coronary angioplasty (CARDIAC STENTS PLACED). Concurrent medical conditions included Blood pressure high, Parkinson's disease, Shellfish allergy (shrimp allergy), Non-tobacco user, Abstains from alcohol, Sulfonamide allergy (SULFA ALLERGY MANIFESTED BY VASCULITIS), Arthritis and Broken bones. Concomitant products included NEBIVOLOL HYDROCHLORIDE (BYSTOLIC) and ISOSORBIDE MONONITRATE for Blood pressure high, BACLOFEN for Parkinson's disease, CLONAZEPAM (KLONOPIN), POTASSIUM CANRENOATE (ALDACTONE [POTASSIUM CANRENOATE]), FAMOTIDINE, LIDOCAINE, AMANTADINE, ACETYLSALICYLIC ACID (ASPIRIN 81), FOLIC ACID, AZELASTINE, DOCOSAHEXAENOIC ACID, EICOSAPENTAENOIC ACID, TOCOPHERYL ACETATE (OMEGA 3 [DOCOSAHEXAENOIC ACID;EICOSAPENTAENOIC ACID;TOCOPHERYL ACETATE]), OMALIZUMAB (XOLAIR), CARBIDOPA, LEVODOPA (RYTARY), SALBUTAMOL SULFATE (ALBUTEROL [SALBUTAMOL SULFATE]), MONTELUKAST, VITAMIN B NOS, TRAMADOL and CLONAZEPAM for an unknown indication.   On 03-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 04-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 16-Jun-2021, the patient started CARBIDOPA, LEVODOPA (DUOPA) (Other) 2.6 milliliter. On 25-Oct-2021, the patient received third dose of TOZINAMERAN (PFIZER BIONTECH COVID-19 VACCINE) (Intramuscular) 1 dosage form. On an unknown date, the patient started TELMISARTAN (Oral) at an unspecified dose. On 20-Jun-2021, the patient experienced STOMA SITE INFECTION (STOMA INFECTION). In September 2021, the patient experienced STOMA SITE INFECTION (Stoma site infection). On 25-Oct-2021, the patient experienced VACCINATION SITE PAIN (PAIN AT INJECTION SITE) and VACCINATION SITE SWELLING (SWELLING AT INJECTION SITE). On an unknown date, the patient experienced PARKINSON'S DISEASE (PARKINSONS DISEASE PROGRESSION) (seriousness criterion medically significant), GASTROOESOPHAGEAL REFLUX DISEASE (Esophageal reflux), FALL (FREQUENT FALLS), HEAD INJURY (HIT HEAD), DIZZINESS (Light headedness), COVID-19 IMMUNISATION (Patient had received 2 doses of mRNA-1273 vaccine prior to Pfizer COVID-19 vaccination) and INTERCHANGE OF VACCINE PRODUCTS (Patient had received 2 doses of mRNA-1273 vaccine prior to Pfizer COVID-19 vaccination). The patient was treated with CEPHALEXIN [CEFALEXIN] at an unspecified dose and frequency. On 05-Jul-2021, STOMA SITE INFECTION (STOMA INFECTION) had resolved. In October 2021, STOMA SITE INFECTION (Stoma site infection) had resolved. At the time of the report, PARKINSON'S DISEASE (PARKINSONS DISEASE PROGRESSION), GASTROOESOPHAGEAL REFLUX DISEASE (Esophageal reflux), FALL (FREQUENT FALLS), HEAD INJURY (HIT HEAD) and DIZZINESS (Light headedness) had not resolved, VACCINATION SITE PAIN (PAIN AT INJECTION SITE) and VACCINATION SITE SWELLING (SWELLING AT INJECTION SITE) was resolving and COVID-19 IMMUNISATION (Patient had received 2 doses of mRNA-1273 vaccine prior to Pfizer COVID-19 vaccination) and INTERCHANGE OF VACCINE PRODUCTS (Patient had received 2 doses of mRNA-1273 vaccine prior to Pfizer COVID-19 vaccination) outcome was unknown.            The ROA of suspect DUOPA was reported as Percutaneous J-tube.  Pump Serial Number: 579190, Gel/Cassette Lot Number: 1144163  It was reported that suspect TELMISARTAN was given 2-3 years ago.  Gastroesophageal reflux disease include symptoms of Dry heaves (Retching) and Nausea. Stoma site infection (Dated: SEP-2021 to OCT-2021) include symptoms of Crust at stoma site (scab), drainage at stoma site, redness cellulitis at stoma site and infection. Parkinson's disease include symptoms of WORSENED UNSTABLE GAIT, Muscle spasms and Muscle pain.  Orthostatic Blood pressure was performed however result was not reported.  The reporter's causality for the events of ESOPHAGEAL REFLUX, DRY HEAVES, CRUST AT STOMA SITE, STOMA INFECTION onset in September 2021, NAUSEA, DRAINAGE AT STOMA SITE and INFECTION was not provided. The reporter's causality for the events of STOMA INFECTION onset 20 Jun 2021 with DUOPA(LEVODOPA/CARBIDOPA) was a reasonable possibility. The reporter's causality for the events of REDNESS CELLULITIS AT STOMA SITE, WORSENED UNSTABLE GAIT, PARKINSONS DISEASE PROGRESSION, FREQUENT FALLS, HIT HEAD, ORTHOSTATIC BLOOD PRESSURE, MUSCLE SPASMS, MUSCLE PAIN, PAIN AT INJECTION SITE, SWELLING AT INJECTION SITE and LIGHT HEADEDNESS with DUOPA(LEVODOPA/CARBIDOPA) was no reasonable possibility.  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 is a spontaneous case, reported by a consumer, concerning a 72-year-old male patient with relevant medical condition of Parkinson's disease, who experienced the unexpected serious (medically significant) event of Parkinson's disease, reported as Parkinson's disease aggravated, in the context of the 2-dose primary series of mRNA-1273 vaccine. Latency cannot be properly assessed since event onset date was not provided. Patient had received 2-dose primary series of mRNA-1273 vaccine given at an interval of 29 days which falls within the recommended vaccine dosing schedule, approximately 7 months and 3 weeks prior to Pfizer COVID-19 vaccination (Revaccination with different COVID-19 vaccine and Interchange of vaccine products). It was reported that the patient also had muscle pain and spasm, worsened unstable gait, lightheadedness with associated fall and head injury, esophageal reflux with associated dry heaves and nausea, stoma site infection with associated drainage, redness and crusting at stoma site, and pain and swelling at injection site. Patient underwent orthostatic blood pressure, however no result was reported. The patient was treated with Cephalexin for an unknown indication. No further details about the clinical course, other diagnostic procedures and other treatments were provided. It was reported that the event Parkinson's disease aggravated was not resolved. The medical condition of Parkinson's disease remains as a confounder for the event Parkinson's disease aggravated. The benefit-risk relationship of mRNA-1273 is not affected by this report.; Sender's Comments: This is a spontaneous case, reported by a consumer, concerning a 72-year-old male patient with relevant medical condition of Parkinson's disease, who experienced the unexpected serious (medically significant) event of Parkinson's disease, reported as Parkinson's disease aggravated, in the context of the 2-dose primary series of mRNA-1273 vaccine. Latency cannot be properly assessed since event onset date was not provided. Patient had received 2-dose primary series of mRNA-1273 vaccine given at an interval of 29 days which falls within the recommended vaccine dosing schedule, approximately 7 months and 3 weeks prior to Pfizer COVID-19 vaccination (Revaccination with different COVID-19 vaccine and Interchange of vaccine products). It was reported that the patient also had muscle pain and spasm, worsened unstable gait, lightheadedness with associated fall and head injury, esophageal reflux with associated dry heaves and nausea, stoma site infection with associated drainage, redness and crusting at stoma site, and pain and swelling at injection site. Patient underwent orthostatic blood pressure, however no result was reported. The patient was treated with Cephalexin for an unknown indication. No further details about the clinical course, other diagnostic procedures and other treatments were provided. It was reported that the event Parkinson's disease aggravated was not resolved. The medical condition of Parkinson's disease remains as a confounder for the event Parkinson's disease aggravated. The benefit-risk relationship of mRNA-1273 is not affected by this report.