Age: 90.0
Sex: F
Vaccine: COVID19
Symptoms: Muscle atrophy
Clinical narrative: This spontaneous case was reported by a consumer and describes the occurrence of BEDRIDDEN (Bedridden), MALAISE (They could not get her out of bed to walk around and do things because she was not feeling well), ASTHENIA (Weakness), GENERAL PHYSICAL HEALTH DETERIORATION (Difficulty with her health) and MUSCLE ATROPHY (muscles are atrophied) in a 90-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 052E21A) for COVID-19 prophylaxis. The occurrence of additional non-serious events is detailed below. The patient's past medical history included COPD. Previously administered products included for Product used for unknown indication: Pfizer (Dose 1, Lot No EP6955.) on 27-Mar-2021, Pfizer (Dose 2 , Lot ER8731.) on 17-Apr-2021, Pfizer (Dose 3 and Lot EW0182.) on 22-Oct-2021. Past adverse reactions to the above products included No adverse event with Pfizer, Pfizer and Pfizer. Concurrent medical conditions included Lung disease (MAC rare lung disease) since 2019 and Pseudomonas infection NOS. Concomitant products included TOZINAMERAN (PFIZER BIONTECH COVID-19 VACCINE) from 14-Jul-2022 to 14-Jul-2022 for an unknown indication. On 11-Nov-2021, the patient received fourth dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 11-Nov-2021, the patient experienced EXTRA DOSE ADMINISTERED (Received 3rd booster dose Pfizer COVID Vaccine and 3 weeks later received a Moderna COVID booster), COVID-19 IMMUNISATION (patient received Pfizer Covid-19 vaccine and then received Moderna Covid-19 vaccine) and INTERCHANGE OF VACCINE PRODUCTS (patient received Pfizer Covid-19 vaccine and then received Moderna Covid-19 vaccine). On 06-Jun-2022, the patient experienced COVID-19 (COVID-19). On an unknown date, the patient experienced BEDRIDDEN (Bedridden), MALAISE (They could not get her out of bed to walk around and do things because she was not feeling well), ASTHENIA (Weakness), GENERAL PHYSICAL HEALTH DETERIORATION (Difficulty with her health), MUSCLE ATROPHY (muscles are atrophied), DIZZINESS (Dizzy) and FATIGUE (Tiredness). On 11-Nov-2021, EXTRA DOSE ADMINISTERED (Received 3rd booster dose Pfizer COVID Vaccine and 3 weeks later received a Moderna COVID booster) had resolved. At the time of the report, BEDRIDDEN (Bedridden), MALAISE (They could not get her out of bed to walk around and do things because she was not feeling well), ASTHENIA (Weakness), GENERAL PHYSICAL HEALTH DETERIORATION (Difficulty with her health), MUSCLE ATROPHY (muscles are atrophied), DIZZINESS (Dizzy), FATIGUE (Tiredness), COVID-19 (COVID-19), COVID-19 IMMUNISATION (patient received Pfizer Covid-19 vaccine and then received Moderna Covid-19 vaccine) and INTERCHANGE OF VACCINE PRODUCTS (patient received Pfizer Covid-19 vaccine and then received Moderna Covid-19 vaccine) outcome was unknown. No concomitant medication was reported. Treatment medication was not reported. The patient took pill thing, could not take Paxlovid and had to take something starting with an M and was not effective as the others. She could not take Paxlovid due to kidneys. No name, lot or expiration for the medication starting with M that was not as effective. She was on all kinds of medications. Blood pressure medications, vitamins that they give her. Sender's Comments: This is a spontaneous case of extra dose administered for this 90-year-old, female patient with relevant medical history of Chronic Obstructive Pulmonary Disease (COPD and Mycobacterium avium complex (MAC) lung disease (2019) on unspecified inhaled antibiotics every few months, and past drug history of administration of three doses of the Pfizer/BioNTech COVID-19 mRNA vaccine, who experienced the unexpected, non-serious AESI of COVID-19, and other unexpected and expected, non-serious events. The event COVID-19 occurred approximately 7 months after receiving the third dose of the Pfizer/BioNTech COVID-19 mRNA vaccine and approximately 6 months after receiving a dose (fourth dose in the COVID-19 vaccination series) of the mRNA-1273 vaccine (revaccination with different COVID-19 vaccine and interchange of vaccine products). The start dates of the other events were not provided, hence, the onset latency could not be assessed. Of note, the patient also received a fourth dose (fifth dose in the COVID-19 vaccination series) of the Pfizer/BioNTech COVID-19 mRNA vaccine approximately 8 months after receiving the mRNA-1273 vaccine. It was reported that the patient did not have reactions to the first three doses of the Pfizer/BioNTech COVID-19 mRNA vaccine. After receiving the third dose of the Pfizer/BioNTech COVID-19 mRNA vaccine, the patient was admitted for rehabilitation to increase her physical activity. While in the rehabilitation facility, it was reported that the patient was inadvertently given the mRNA-1273 vaccine which was only 20 days after receiving the third dose of the Pfizer/BioNTech COVID-19 mRNA vaccine. On unspecified dates after receiving the mRNA-1273 vaccine, the patient had difficulty because she was dizzy and tired. She could not go out of bed to walk around and do things because she was not feeling well. She would take two to three steps during the rehabilitation session and would sit down because she was dizzy and weak. It was also reported that the patient was bedridden because the facility personnel don't get her up and didn't try, and that the patient's muscles were atrophied. Approximately 6 months after receiving the mRNA-1273 vaccine, the patient experienced COVID-19. No symptoms were reported. She was given an unspecified medication. The patient was also quarantined for 12 days and 1.5 week later, she received the fourth dose (fifth dose in the COVID-19 vaccination series) of the Pfizer/BioNTech COVID-19 mRNA vaccine. The outcome of the event COVID-19 was unknown at the time of the report. The history of COPD, which is a known risk factor for COVID-19, remains a confounder. Of note, patients with MAC lung disease usually have a weakened immune system, hence, this may also be a confounder for the event COVID-19. The patient's advanced age (high risk for infections) also remains a confounder. The benefit-risk relationship of the mRNA-1273 vaccine is not affected by this report.