Moderna

Patient left the pharmacy and was at his table eating. He dropped his bowl and appeared to be shaking and his eyes rolled back. He was unresponsive so his wife called 911 and an ambulance came and transported him to the Hospital. Concern at the time was either a seizure or stroke.

Tongue sensation/metallic taste Narrative: Patient received first dose of COVID-19 vaccination on 2/4/21. Mild reaction, tongue felt funny, metallic taste, watery eyes, 911 called but he refused to go to the ER for evaluation, RN stayed with him for an hour with EMS, vitals remained stable provider contacted and the patient daughter. He was ok before the RN left).

Patient, who wears a hearing aid, claim that his hearing was affected. He said sound had diminished and was slightly dizzy.

Patient developed tearing of the right eye on 2/24/21 followed by progressive right side facial weakness that resulted in an ED visit on 2/27/21.

Sudden partial hearing loss with tinnitus, right ear, confirmed as SSNHL by ENT specialist and audiogram. Started on 15 day tapered therapy, starting with 10 mg of oral dexamethasone. Hearing loss subsiding slowly improving over subsequent 10 days of therapy. Tinnitus persists so far.

Systemic: lips numbness-Mild, Systemic: Tingling (specify: facial area, extemities)-Mild, Additional Details: patient had lip numbness after taking 2nd dose of COVID Vaccine

Patient presented to ER on 5/22/21 complaining of left eye swelling and vision being blurred. Physician diagnosed as a corneal abrasion and left periorbital cellulitis. Patient came back to the ER on 5/24/21 complaining of left side of face drooping. Patient stated he noticed this the day prior. Patient was having difficulty closing his left eye. Today 5/24 he is drooping on the left side of his face and difficulty drinking water without running out of his mouth. No chest pain. According to physician, exam was most consistent with Bell's palsy but given patient's HTN, age and bounce back status, a CT was done. Everything was negative. Physician treated patient for Bell's Palsy with Valtrex and prednisone. This all happened within two weeks of receiving the 2nd dose of the Moderna Vaccine.

My arm has been weak ever since I got the injection, My vision gradually became blurry in my left eye over the course of two weeks. I saw a rheumatologist that diagnosed macular edema.

My birthfather had an adverse reaction after he got his 1st Moderna COVID vaccine. He lives alone and was doing well with some underlying conditions. The day of the shot was fine. The next AM, he had vision changes and sudden numbness in his R arm/leg and fell after getting up. ?The numbness went away pretty quickly, but the visual changes remained. He refused to go to the ER/Dr. The next week and a half, he was weak, tired, and couldn?t think as clearly. ?He was brought to the ER? on Wed, 3/3/21 at Hospital. He was found to have a low oxygen level, possible a-fib, fluid retention, emphysema, and aortic stenosis, in addition to his other health issues. ?The Dr said his symptoms the day after the vaccine were a mini-stroke.. He was released from the hospital on Friday, 3/5/21. On Saturday, Hospice came to see him, since nothing can be done for his medical conditions; however, they decided not to sign him up yet, since he I was told they didn't feel he needed to, at this time. One of my sisters is staying with him during the day until he builds his strength back up. Do you think his Mini stroke and health changes had anything to do with the vaccine? He will not be getting the second COVID shot. ?We?re all caught between a rock and a hard place as far as what to do, esp for older folks.

First shot 1-20-2021 Immediate flushing with hot ears upon injection. Lasted all day. Sore arm at injection site lasted two days. Leg and back pains in three days which disappeared within the day. February 4, 2021 entire body got cold. 15 minutes later cold chills and shivers for an hour. Went to hospital emergency where treated for blood infection with intravenous antibiotics for 6 days. Then home treated with intravenous antibiotics with home health care until February 22, 2921. Experienced many long period cold spells of entire body both in hospital and home. Still get them until this date on occasion. I am very sensitive to cold.

Leg and hip weakness, Swelling of leg and feet. Acking legs, cramping legs and feet. Shortness of breath, eyes not focusing

2/4/21 - awoke from sleep 11 PM with jaw/teeth pain lasting several hours 2/5/21 - extreme weakness, rapid heartbeat, fatigue. Slept on and off all day. 2/ 6 - 2/8/21 - irregular heartbeat, rapid heartbeat, fatigue 2/8/ 21 - appt with primary car, Physician 3:30PM, EKG showed afib, BP 178/100, pulse 140 - sent directly to ER for further testing. Physician in ER: cardiac enzymes normal, chest xray normal, administered metoprolol IV which decreased heartrate from 140 to 84. Prescribed Metoprolol 25MG 2x/day and follow up with cardiologist. 2/8/- 2/12/21 - with metoprolol heart rate remained in 80s, weakness, fatigue 2/12/21 - appt with cardiology; Physician Assistant - EKG showed afib, heartrate 80, BP 142/80 - ordered echocardiogram 2/18/21

AFib; Jaw and tooth pain; Jaw and tooth pain; Rapid heartbeat/Rapid pulse; Extreme weakness; Irregular heartbeat; blood pressure was 142/80; A spontaneous report was received from a consumer concerning a 92-years-old, male patient who experienced AFib (atrial fibrillation), rapid heartbeat/rapid pulse, extreme weakness, irregular heartbeat, blood pressure was 142/80, jaw and tooth pain. The patient's medical history was not provided. Products known to have been used by the patient, within two weeks prior to the event, included levothyroxine sodium, metoprolol tartrate, pravastatin, fexofenadine, vitamin D, acetylsalicylic acid, fluticasone propionate and latanoprost. On 04 Feb 2021, approximately prior to the onset of the symptoms, the patient received their first of two planned doses of mRNA-1273 [Lot number 004M20A] intramuscularly in the for prophylaxis of COVID-19 infection. On 04 Feb 2021, the patient woke up that night with jaw and tooth pain. He later experienced rapid heartbeat, extreme weakness, irregular heartbeat, rapid pulse and AFib (atrial fibrillation) which was confirmed by his primary care physician (PCP) on 06 Feb 2021. On 08 Feb 2021, patient repoted his blood pressure was 142/80. Treatment for the event included metoprolol IV. Action taken with mRNA-1273 in response to the events was not provided. The events rapid heartbeat/rapid pulse and extreme weakness were considered recovered/resolved or on 08 Feb 2021 and the outcome of the events AFib (atrial fibrillation), irregular heartbeat, blood pressure was 142/80, jaw and tooth pain were unknown.; Reporter's Comments: Very limited information regarding this events has been provided at this time. Further information has been requested. Company assessed the events to be unlikely related to company product.

ice cold body; shivering-chills; leg pain; back pain; head pain; injection site soreness; shoulder pain; flushing; cramping neck pain; red hot ears; A spontaneous report was received from a 92-year-old, male patient, who received Moderna's COVID-19 vaccine (mRNA-1273) and experienced flushing with red hot ears (ear discomfort), mild soreness at the injection site (vaccination site pain), right-sided cramping neck pain (muscle spasms) accompanied by shoulder pain (arthralgia )radiating to the head (headache), leg pain (pain in extremity), back pain, body became ice cold, chills and shivering (chills). The patient's medical history, as provided by the reporter, included pulmonary fibrosis, sleep apnea, acid reflux and prostatitis. Concomitant medications reported included aciphex and ativan. On 20 Jan 2021, approximately two weeks prior to the onset of the events, the patient received their first of two planned doses of mRNA-1273 (Lot number: 027L20A) intramuscularly in the left deltoid for prophylaxis of COVID-19 infection. On 20 Jan 2021, the patient experienced immediate flushing with red hot ears which persisted throughout the day and mild soreness at the injection site lasting approximately 24 to 48 hours. He experienced two instances of right-sided cramping neck pain accompanied by shoulder pain radiating to the head, lasting 5 to 10 minutes per episode between 20 Jan 2021 and 04 Feb2 021. These episodes were brief and have not returned and awaking to both legs and his back "filled with pains" on 23 Jan 2021. The leg pains subsided upon standing; back pain lasted all day 23 Jan2 021. The patient felt normal from 24 Jan 2021 until 04 Feb 2021. On 04 Feb 2021, the patient's whole body became ice cold at approximately 3PM. By 3:15PM he was experiencing chills and shivering that lasted approximately one hour. Patient called his physician, and was directed to the Emergency Room (ER) immediately. There he received blood tests and prophylactic broad spectrum antimicrobial therapy immediately upon admission. Patient reports that Infectious Disease confirmed there were two strains of bacteria present in his bloodstream. From the patient additional samples were collected for culture to tailor antimicrobial therapy accordingly. He also said he was hospitalized for six days and discharged on 10 Feb 2021 with at home Iintravenous (IV) infusion device to administer continuous (24 hour) antibiotic therapy for a full 14 days. He was released from the hospital to his daughter's care. He had no history of significant adverse events or allergic reactions post vaccine administration. He is concerned about the origin of the infection, as no source could be confirmed per Infectious Disease. The patient is concerned the infection could have stemmed from the vaccine or it's administration. He attests that his physician wants him to proceed with his second dose of Moderna. Action taken with mRNA-1273 in response to the events is unknown. The events, flushing with red hot ears, mild soreness at the injection site, right-sided cramping neck pain accompanied by shoulder pain radiating to the head, leg pain, back pain, body became ice cold, chills and shivering were considered resolved.; Reporter's Comments: Based on the current available information and temporal association between the use of the product and the start date of the event, a causal relationship cannot be excluded.

Fell; Felt like he was dying; couldn't taste, and had a terrible taste in his mouth; Could not smell; Stomach hurt; A spontaneous report was received from a consumer concerning a 92-years-old female patient who received Moderna's COVID-19 vaccine (mRNA-1273) and experienced could not taste and had terrible taste in his mouth (ageusia), could not smell (anosmia), his stomach hurt (abdominal pain upper), felt like he was dying (feeling abnormal) and he fell (fall). The patient's medical history included hospitalization due to COVID-19. No relevant concomitant medications were reported. The patient received their first of two planned doses of mRNA-1273 (Batch number not provided) an unspecified date. On 22 Feb 2021, two hours prior to the onset of the symptoms, the patient received their second of two planned doses of mRNA-1273 (Batch number not provided) intramuscularly for prophylaxis of COVID-19 infection. Two hours after the vaccination, the patient could not taste, and had a terrible taste in his mouth The patient could not smell and his stomach hurt. The patient felt like he was dying. On 23 Feb 2021, the patient fell. 911 was called and the patient was hospitalized. Treatment for the event included electrolytes. The patient had an abnormal electrocardiogram (EKG The patient received both scheduled doses of mRNA-1273 prior to the events; therefore, action taken with the drug in response to the events is not applicable. The outcome of the events, could not taste and had a terrible taste in his mouth (ageusia), could not smell (anosmia), his stomach hurt (abdominal pain upper), felt like he was dying (feeling abnormal) and he fell (fall), were unknown.; Reporter's Comments: Very limited information regarding the event has been provided at this time. Noting advance age is a risk factor. Noting the history of advance age and previous COVID infection may remain as risk factors. Further information has been requested.

ON 02/08/2021 AROUND 0600 RESIDENTCOMPLAINED OF MOUTH PAIN AND RECEIVED OXYCODONE. DURING THE COURSE OF THE MORNING, RESIDENT EXHIBITED A FEW EPISODES OF LABORED/SHALLOW BREATHING AND SOB AT RESTING. 0XYGEN SATURATION RATE WAS 93-98% ON ROOM AIR, LUNG SOUNDS CLEAR IN ALL LOBES AND PULSE AND TEMPERATURE WITHIN NORMAL RANGE. AS THE DAY PROGRESSED, VITAL SIGNS REMAINED STABLE BUT RESIDENT CONTINUED TO HAVE PERIODS OF SOB/LABORED BREATHING.FAMILY AND NURSE PRACTIONER UPDATED AND THE ORDER WAS RECEIVED TO SEND PATIENT TO MEDICAL CENTER ER FOR EVALUATION PER AMBULANCE. RESIDENT TRANSPORTED AT 1425. RESIDENT RETURNED FROM THE ER AT 1830 ON HOSPICE CARE WITH THE DIAGNOSIS OF: ACURE RESPIRATORY FAILURE WITH HYPOXIA AND END OF LIFE DECISION MAKING. RESIDENT WAS MADE COMFORTABLE AND MONITORED DURING THE NIGHT AND EXPIRED AT 0630 ON 02/09/2021.

Dad reports that he is exhausted, achy, and has an upset stomach and food does not taste or sound good. He said he?s feeling a little better right now but he feels he got a second setback from the vaccine

Another customer in the store called over to the technician and pharmacist on duty stating the patient looked sick. He had dropped his timer that was counting down his 15 min post dose wait time. Pharmacist approached patient and asked him how he was doing. He was initially non-responsive, eyes were slightly glazed over. I repeatedly asked him his name and how he was doing. He began to respond after prompting, saying he felt very hot and sweaty. He stated he was thirsty and he hadn't eaten anything before his dose. Technician obtained a glass of water and a granola bar for the patient. Patient began to improve just minutes after food and water. He stated he thought he had stood for too long while waiting for his shot and hadn't eaten that morning so he began to feel sick. Patient recovered enough to call his daughter to pick him up from the store. His daughter arrived to pick him up and patient was able to walk out of the store without issue.

Patient had requested a split dose of the 2nd Moderna vaccine due to prior history of having shingles soon after 1st dose. Received 0.05ml at ~3pm. Around 3.12 or 3.18pm he began to complain of L eye blurred vision. Pt was evaluated and noted to have no other headaches, dizziness, SOB, chest pain. He reported that R eye vision was okay. Unable to read first line of snellen eye chart with left eye. Visual fields were intact, EOMI, and PERRL. He denies a shade being pulled over his eye. Pt was taken to the ED where vital signs were stable. A brief check showed stable blood pressure and blood glucose. Pt then eloped from the ED and went to another hospital's ED. There he was found to have a left central retinal artery occlusion.

First shot uneventful. Second shot, patient had a fall the next morning, where his knees weakened and gave out. He had been active prior to this, without similar events. He also had extreme brain fog, and has had long-lasting fatigue, weakness and decreased appetite since then. This writer saw him 4/5/2021. He has now developed thrush without any evident cause. He did lose his sense of taste but that is returning.

- Felt weak and light headed after receiving vaccine, continued to feel weak up until 07/12/21. ( Least of problems ) - Feb. 22 begin to lose hearing in my right ear ( Went to see an ENT ) found to be deaf - Recovered some hearing 2-3 days later - Started bleeding from lower GI tract 03/2021 went to hospital 03/06/21 lost 1/3 of blood, spent 4 days in hospital - I Assumed the bleeding was trigged by the vaccination