Age: 63.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Full blood count, Interchange of vaccine products, Metabolic function test, Pain in extremity, SARS-CoV-2 test
Clinical narrative: COPD exacerbation/it got worse; caught covid; she had more of a sore arm and her arm hurt for four days after the vaccine; arthritis; Tired; interchange of vaccine products; revaccination with different Covid-19 vaccine; This spontaneous case was reported by a non-health professional and describes the occurrence of CHRONIC OBSTRUCTIVE PULMONARY DISEASE (COPD exacerbation/it got worse) and COVID-19 (caught covid) in a 63-year-old female patient who received SPIKEVAX NOS (SPIKEVAX NOS) for COVID-19 prophylaxis. The occurrence of additional non-serious events is detailed below.    Co-suspect product included non-company product TOZINAMERAN (PFIZER BIONTECH COVID-19 VACCINE) for an unknown indication.    Concurrent medical conditions included Osteoarthritis (since she was in her late 30s), COPD exacerbation, Spinal stenosis (joint disease that began when she was in  her late 30s or early 40s.) and Facet joint syndrome (Facet joint disease in her cervical, thoracic and lumbar spine and it was facet arthropy.).   On an unknown date, the patient received dose of SPIKEVAX NOS (SPIKEVAX NOS) (unknown route) 1 dosage form and dose of TOZINAMERAN (PFIZER BIONTECH COVID-19 VACCINE) (unknown route) 1 dosage form. On 28-Sep-2023, the patient experienced CHRONIC OBSTRUCTIVE PULMONARY DISEASE (COPD exacerbation/it got worse) (seriousness criterion hospitalization) and COVID-19 (caught covid) (seriousness criterion hospitalization). On an unknown date, the patient experienced PAIN IN EXTREMITY (she had more of a sore arm and her arm hurt for four days after the vaccine), ARTHRITIS (arthritis), FATIGUE (Tired), INTERCHANGE OF VACCINE PRODUCTS (interchange of vaccine products) and COVID-19 IMMUNISATION (revaccination with different Covid-19 vaccine). The patient was hospitalized on 28-Sep-2023 due to CHRONIC OBSTRUCTIVE PULMONARY DISEASE and COVID-19. The patient was treated with NIRMATRELVIR, RITONAVIR (PAXLOVID) at an unspecified dose and frequency. At the time of the report, CHRONIC OBSTRUCTIVE PULMONARY DISEASE (COPD exacerbation/it got worse), COVID-19 (caught covid), PAIN IN EXTREMITY (she had more of a sore arm and her arm hurt for four days after the vaccine), ARTHRITIS (arthritis), FATIGUE (Tired), INTERCHANGE OF VACCINE PRODUCTS (interchange of vaccine products) and COVID-19 IMMUNISATION (revaccination with different Covid-19 vaccine) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 28-Sep-2023, SARS-CoV-2 test: Positive. On an unknown date, Full blood count: It was ok. On an unknown date, Metabolic function test: It was ok. On an unknown date, Thyroid function test: It was ok. On an unknown date, Urine analysis: It was ok. On an unknown date, White blood cell count: White count was fine and no infection or anything like that.     The action taken with SPIKEVAX NOS (SPIKEVAX NOS) (Unknown) was unknown.   No concomitant medication was reported. Patient received Pfizer Covid vaccine she had received two weeks ago on this Saturday, and she stated at the beginning of covid she started with Moderna and kept up with the boosters and last August she caught covid and stated she had taken Paxlovid, and it worked very well while taking it and stated she experienced no problems or side effects, and it kept her from getting pneumonia.  Once she stopped the Paxlovid, she was in the hospital twice and did have COPD and arthritis. It was reported that patient received Pfizer bivalent vaccine in November.  Patient had pain in her pubic area radiating down the front and back of her legs and provided that last week, four days after receiving the vaccine, she had an EGD diagnostic testing which was previously scheduled to receiving the vaccine and stated that this was the only different thing she had taken in this short of time and reported feeling as if someone beat her up in the middle of the night and that everything seems worse and she did not feel well and was ungodly tired. Stated she was just blah and was having to fight more in her chest with her COPD and mentioned that she was on two different inhalers and some other things.  For her two hospitalizations, stated the COPD exacerbation was the reason both times and the first time was for COPD exacerbation and testing positive for covid; she thought the first hospitalization was 28-Sep-2023 and she was discharged on like 2-3 days later. After a couple of days patient received her IV medicine.  For the second hospitalization, stated it was like 14-Oct-2023 or something like that and it was for COPD and was really that she just did not feel well and was like not getting better; she was admitted and ended up coming home on oxygen and had to wear it at night to sleep and to exercise since she had covid.   This case was linked to US-MODERNATX, INC.-MOD-2024-772104, US-MODERNATX, INC.-MOD-2024-772105 (Linked Report).  Company Comment: This is a spontaneous case concerning a 63-year-old female patient with concurrent medical conditions included chronic obstructive pulmonary disease, who experienced  the serious (due to hospitalization) unexpected events of chronic obstructive pulmonary disease and Covid-19 (among other non-serious events) which occurred unknown days after a dose of SPIKEVAX COVID-19 VACCINE NOS vaccine. As the patient received doses of Pfizer vaccine; "interchange of vaccine products" was also noted in this case. It was reported that on 28-Sep-2023, the patient was tested positive to SARS-CoV-2, was hospitalized with exacerbation of her COPD, and for Covid-19 disease. She was treated with PAXLOVID at an unspecified dose and frequency for five days, and as she went off of it, it her symptoms came back again; also, she experienced pain in extremity, fatigue and arthritis. At the time of the report, the outcome of the events was reported as unknown. The concurrent condition of COPD is a contributor for the same event. The benefit-risk relationship of SPIKEVAX COVID-19 VACCINE NOS  vaccine is not affected by this report.; Sender's Comments:  US-MODERNATX, INC.-MOD-2024-772104:same reporter (case for another friend had Moderna) US-MODERNATX, INC.-MOD-2024-772105:same reporter (case for one had Moderna)