Age: 75.0
Sex: F
Vaccine: COVID19
Symptoms: Disorientation, Headache, Product dose omission issue, Tinnitus, Withdrawal syndrome
Clinical narrative: hospitalized due to withdrawal symptoms from these two medications; 2nd dose was given 3.5 months from the first dose; Headache; Ringing in the ears; Disorientation; This spontaneous case was reported by a consumer and describes the occurrence of WITHDRAWAL SYNDROME (hospitalized due to withdrawal symptoms from these two medications) in a 75-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 027A21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.   On 18-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On an unknown date, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 18-Mar-2021, the patient experienced WITHDRAWAL SYNDROME (hospitalized due to withdrawal symptoms from these two medications) (seriousness criterion hospitalization). On 24-Mar-2021, the patient experienced TINNITUS (Ringing in the ears), DISORIENTATION (Disorientation) and HEADACHE (Headache). On an unknown date, the patient experienced PRODUCT DOSE OMISSION ISSUE (2nd dose was given 3.5 months from the first dose). The patient was hospitalized on 18-Mar-2021 due to WITHDRAWAL SYNDROME. The patient was treated with ROPINIROLE at an unspecified dose and frequency and ZOLPIDEM TARTRATE (AMBIEN) at an unspecified dose and frequency. At the time of the report, WITHDRAWAL SYNDROME (hospitalized due to withdrawal symptoms from these two medications), TINNITUS (Ringing in the ears), DISORIENTATION (Disorientation) and HEADACHE (Headache) outcome was unknown and PRODUCT DOSE OMISSION ISSUE (2nd dose was given 3.5 months from the first dose) had resolved.            No concomitant medications were reported. On an unknown date, the patient called to inquire if should start the series of Moderna COVID-19 vaccine or should take 2nd dose even if it had been 3.5 months from first dose. At the time of first dose the patient was coming off of two heavy medications Ropinirole and Ambien and was hospitalized due to the withdrawal symptoms.  The patient was experiencing terrible withdrawal symptoms. At first patient thought it was all from the vaccine but later was hospitalized due to withdrawal symptoms from these two medications. Because of this reason missed the 2nd dose within the recommended dosing interval. Tried reaching out to medical facilities around the area and they informed that patient needed to start the series all over again. The patient went to the pharmacy on 11-Jul-2021, mentioned to Pharmacist what other facilities had informed about starting the series over. However, the pharmacist said that patient could only take one more dose since already had one dose.  Based on the current available information and temporal association between the use of the product, and the start date of the events, a causal relationship cannot be excluded.  For the event Drug withdrawal syndrome, there are other confounders/do-suspects. Further information has been requested.   Most recent FOLLOW-UP information incorporated above includes: On 12-Jul-2021: Patient details, therapy details, new events and treatment drugs were updated.; Sender's Comments: Based on the current available information and temporal association between the use of the product, and the start date of the events, a causal relationship cannot be excluded.  For the event Drug withdrawal syndrome, there are other confounders/do-suspects. Further information has been requested.