Age: 63.0
Sex: M
Vaccine: COVID19
Symptoms: Breakthrough COVID-19
Clinical narrative: Breakthrough COVID; This spontaneous case was reported by a patient and describes the occurrence of BREAKTHROUGH COVID-19 (Breakthrough COVID) in a 63-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 001821A, 007B21A and 026D4A) for COVID-19 prophylaxis.     He had minor COPD that was more like an asthma COPD. It doesn't go into his lungs.  Concurrent medical conditions included COPD (COPD Diagnosed ten years ago/had minor COPD that was more like an asthma COPD), Diabetes (Mild diabetes His A1C about 5.6 and his diabetes was taken care of. Knows a person can get neuropathy from diabetes, but his was well under control. Diagnosed 6-7 years ago) and Obesity (BMI of 34.405).   On 23-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 23-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. In October 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 experienced BREAKTHROUGH COVID-19 (Breakthrough COVID). The patient was treated with NIRMATRELVIR, RITONAVIR (PAXLOVID) in March 2022 for Breakthrough COVID-19, at a dose of 2 dosage form twice a day. At the time of the report, BREAKTHROUGH COVID-19 (Breakthrough COVID) outcome was unknown.            Optic Nerve Edema was started taking Paxlovid either 18-Mar-2022 or 19-Ma-r-2022. Noticed eyesight was blurry and would keep getting a little more blurry. He just thought he needed new glasses.  On 25-Mar-2022, went to eye doctor for the first time. After looking into the eye, was referred to a retina specialist because something was way off, went to retina specialist three days later, 28-Mar-2022 and was then referred to hospital, he was diagnosed with the optic nerve edema. He was not admitted to the hospital. Outcome was permanent. Once the nerve dies from no blood supply, he was blind in that eye basically. It was his right eye, treatment.  There was nothing that could be done Hospital did find he has an underlying problem and that together with the Paxlovid, caused the optic nerve edema. Provides the acronym, NAION and it is some kind of optic neuropathy. He was told he had to be careful about anything that raises his blood pressure or eye pressure and could cause nerve edema.  Paxlovid was given it by the hospital. Finished the course and discarded the packaging. By the time he figured out what was happening, he discarded the packaging. He took two pills twice a day. There were two different kinds of pills. Box said to take two pills in the morning and two at night. Took for 5 days straight.  Instead of giving him a booster for his third dose, he was given a full dose because of his COPD. Optic nerve edema started on the third day after taking the Paxlovid and got a little worse each day. Was told by doctor it normally happens at night and then by the morning, the sight was gone in that eye. With the caller, he was still taking the medicine and his eyesight just got a little worse each day. Cannot drive anymore. Left eye was somewhat better. But he cannot read a cellphone. Left eye wasn't great to begin with. 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 63-year-old male patient with concurrent chronic obstructive pulmonary disease and diabetes, who experienced the unexpected, non-serious adverse event of special interest Breakthrough COVID-19  on an unknown date after receiving the third dose of mRNA-1273 vaccine.  Onset latency cannot be determined as onset date of the event was not provided. SARS-CoV-2 test was not reported. Patient was treated with Nirmatrelvir, Ritonavir (Paxlovid) approximately 5 months after vaccine administration. Patient previously received a 2-dose primary series of mRNA-1273 vaccine given 28 days apart, with the last dose given approximately 7 months prior to current mRNA-1273 vaccine . The concurrent chronic obstructive pulmonary disease and diabetes could be considered as predisposing risk factors.  The benefit-risk relationship of mRNA-1273 vaccine is not affected by this report.; Sender's Comments: This spontaneous case concerns a 63-year-old male patient with concurrent chronic obstructive pulmonary disease and diabetes, who experienced the unexpected, non-serious adverse event of special interest Breakthrough COVID-19  on an unknown date after receiving the third dose of mRNA-1273 vaccine.  Onset latency cannot be determined as onset date of the event was not provided. SARS-CoV-2 test was not reported. Patient was treated with Nirmatrelvir, Ritonavir (Paxlovid) approximately 5 months after vaccine administration. Patient previously received a 2-dose primary series of mRNA-1273 vaccine given 28 days apart, with the last dose given approximately 7 months prior to current mRNA-1273 vaccine . The concurrent chronic obstructive pulmonary disease and diabetes could be considered as predisposing risk factors.  The benefit-risk relationship of mRNA-1273 vaccine is not affected by this report.