Moderna

Systemic: Headache, Systemic: Eyes dilated and difficulty remembering information; symptoms lasted 2 days

10:10 am received Moderna vaccine; observation time 30 min due to previous allergies stated (shrimp-throat closure); 10:37 am RN was observing/talking to pt & mid-sentence pt. reported "I'm feeling funny." Resident's eyes appeared glazed over and she reported "feeing out of it. Like I'm in another world." Resident unable to provide any further specific descriptions of how she felt. Resident's radial pulse felt regular. No loss of consciousness. Resident remained in seated position. 10:39 am Resident reported no improvement & stated, "I feel week". Rn paged for assistance. 10:45 am another staff member arrived with bp cuff. L upper arm blood pressure was 136/72. Heart rate remains regular. Lungs sounded clear. Resident was able to drink a 1/2 glass of orange juice. 10:49 Resident reported feeling " a little better." 10:51 am We noted resident's face appeared flush. No baseline observation of what her cheeks looked like prior to vaccination due to mask, but questionable mild facial swelling present. 10:53 asked resident if she was able to swallow normally. Resident wasn't sure, so RN asked if she felt like she had a lump in her throat or like she needed to clear her throat, but couldn't and she confirmed that her throat felt different than normal. 10:55 am Epi pen administered to L outer thigh by RN. Call placed to EMS. Discussed expected side effects of Epi administration. 10:57 am Resident started to feel anxious and visible shaking present. 11:05 am Resident reported felling slightly better, perked up a bit. 11:08am EMS arrived. 11:10 Ambulance crew arrived. Resident was able to walk to stretcher with assist of 1. 11:17 am Ambulance left with resident. Resident was still reporting "feeling weak".

Patient starting have some tooth/gum pain Sunday night/Jan 30 - 1 night after she received the vaccine. By Monday/Feb 1, pain was severe and she could not chew anything . I was able to get an appt with the dentist on Tuesday/Feb 1 at 930am. We treated at home with Tylenol, very soft foods and rest/heat/ice. Pain, discomfort was gone by Tuesday Feb 1. I did not realize this could be a side effect of the vaccine, but since it came on after receiving the shot and disappeared 3 days after the shot, believe it was a reaction to the shot.

Patient says she felt well after getting the vaccine, but shortly before midnight the same day started feeling fatigue, body pain all over. Next day pain was improved; only remaining jaw pain and fatigue; then the day after pain resolved but persistent fatigue and SOB since then (for 13 days now). Severe dyspnea on exertion; baseline able to walk more than 5 minutes before getting tired; over last 13 days unable to walk from one room to another without severe SOB> Had a ride today so came to urgent care for evaluation. Patient found to be in atrial fibrillation with rapid ventricular rate at 140

arrhythmias; rapid heartbeat; slight nausea; slight headache; light bothered vision for some days; mild chills; A spontaneous report was received from a retired nurse concerning herself who is 90 year old received Moderna COVID-19 vaccine and have experienced arrhythmias, rapid heartbeat, slight nausea, slight headache, some visual problems (light bothered her for some days) and mild chills. The patient has prior history of irregular heart beat . Her relevant concomitant medications were cholesterol medication, Crestor and medication for irregular heartbeat. No information on allergies. On 28-JAN-2021, prior to the onset of events, the patient received her first of two planned doses of COVID-19 vaccine intramuscularly for the prophylaxis of COVID-19 infection. On 30-JAN-2021, 2 days after her vaccination, she developed arrhythmias, rapid heartbeat, slight nausea, slight headache, some visual problems (light bothered her for some days) and mild chills. After one week she felt like no more symptoms ongoing and felt good again. She visited her physician for arrhythmias, and he said, she should keep an eye on it, but no medication yet. She is concerned about her second shot. Action taken with 2nd dose of Moderna COVID-19 vaccine was not reported. The outcome of the events, arrhythmias, rapid heartbeat, slight nausea, slight headache, visual problems and chills were resolved at the time of report.; Reporter's Comments: Based on the current available information and temporal association between the use of the product and the onset date of the events, a causal relationship cannot be excluded. However, patient's advanced age and prior history of irregular heart beat are considered risk factors for arrhythmias.

Within a couple days of second shot, legs became very weak, one was swollen and the other was atrophied. She can barely walk as a result. Can't keep eyes open, can't smile and trouble speaking. Back pain and all over pain.

My sense of smell went crazy. I constantly smell what seems to be a sharp chemical or rancid smell, that doesn't exist, because noone else in my home smells it.

Sudden hearing loss/increased tinnitus. Had incredibly good hearing until after second dose administered.

Weaknesses. Dizziness. Headaches. Blurry vision both eyes. Sleepiness. Strokes. Hospitalization. Death

Loss of vision, experienced different colors, and gradual loss of vision. Diagnosed by retinal specialist as an retinal occlusion, or blood clot in the vein feeding the retina. Left eye is now legally blind. Dr. gave me a shot in the eye at one appt. , and then laser treatment at 3rd appt. No improvement noted. He is still monitoring the eye.

15 minutes following administration of Moderna vaccine, patient felt funny feeling on left side of her head, had increased saliva in mouth and her tongue began to burn. Patient denied shortness of breath, chest pain or swelling. No swelling to lips or mouth was noted and patient was able to swallow secretions without difficulty. Benadryl 25mg was given and patient's symptoms resolved after about 30 minutes. Patient was able to be discharged home with her daughter

A 91 Y.O FEMALE RECEIVED COVID-19 VACCINE ON 01/05/21 AT 11:30AM. FOUR DAYS AFTER THE VACCINATION ON 01/09/21 AT 3:15 PM, SHE CALLED HER DAUGHTER AND TOLD HER THAT HER MOUTH WAS NUMB, LEFT SIDE OF THE MOUTH WAS DROOPING, SO AS HER EYLID. AT ABOUT 5 PM THAT DAY, PATIENT ARRIVED IN TMH ER VIA AMBULANCE. ER DOCTOR RULED OUT HEART ATTACK OR STROKE. PATIENT WAS DIAGNOSED WITH BELL'S PALSY. WAS SENT BACK TO WESTMINSTER OAKS THAT DAY WITH CORTICOSTEROID AND EYE OINTMENT THAT WAS PRESCRIBED BY THE DOCTOR. (INFORMATIONS REPORTED TO ME BY THE DAUGHTER AND THE PATIENT HERSELF) AS OF 01/19/21, PATIENT IS STILL RECOVERING. SPOKE WITH THE PATIENT TODAY 01/19/21, PATIENT STATE SHE STILL HAS THE SIGNS AND SYMPTOMS OF THE BELLS PALSY, BUT SHE SAID SHE'S GETTING BETTER. SHE ALSO STATES THAT TODAY IS THE LAST DAY OF HER CORTICOSTEROID TREATMENT.

Extremely loud noises and hearing in ears. She had to take her hearing aids out and still extremely loud noises and words. She is deaf in one ear and barely hears from the other. When she woke up the next morning it was gone.

Balance disorder; Fall; hurt her arm; Bleeding; Blurry vision; This spontaneous case was reported by a consumer and describes the occurrence of HAEMORRHAGE (Bleeding) in a 91-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for an unknown indication. The occurrence of additional non-serious events is detailed below. The patient's past medical history was not reported On 05-Apr-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) at an unspecified dose. On 05-Apr-2021, the patient experienced blurry vision, lost her balance and fell very hard and was bleeding everywhere and hurt her arm. The patient experienced HAEMORRHAGE (Bleeding) (seriousness criterion medically significant), VISION BLURRED (Blurry vision), FALL (Fall) and PAIN IN EXTREMITY (hurt her arm). On an unknown date, the patient experienced BALANCE DISORDER (Balance disorder). At the time of the report, HAEMORRHAGE (Bleeding), VISION BLURRED (Blurry vision), BALANCE DISORDER (Balance disorder), FALL (Fall) and PAIN IN EXTREMITY (hurt her arm) outcome was unknown. The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown. No concomitant were given No lab details was provided. No treatment information was provided. This case was linked to US-MODERNATX, INC.-MOD-2021-068245 (E2B Linked Report).; Sender's Comments: Based on the current available information which includes a strong temporal association between the use of the product and onset of the reported events, and excluding other etiologies, a causal relationship cannot be excluded. US-MODERNATX, INC.-MOD-2021-068245:Husband case

Eye Problems started with left eye - colored flashing light lasted 15 minutes on March 15th. No accompanying symptoms - eye was then sore. Went to Eye Doctor on March 16 Had another episode in the right eye and a third episode in the right eye - black and white chevron pattern Having intermittent issues since - April 15th

Today around 3pm I administered a first Moderna shot to a patient. She had a long list of allergies to various medications and eggs. I advised her that I would like her to sit for 30 minutes after her shot to be monitored due to this. At about 3:27pm she informed me her upper lip felt tingly. I then offered her 25mg of Benadryl which she took. She waited another 20 minutes and her symptoms felt about the same and she wanted to go home. I offered her another dose of Benadryl or if she wanted me to call EMS. She denied both and bought some Benadryl to take home. I advised her to take another dose if symptoms did not improve or to call EMS if they worsen. She left the pharmacy about 355pm.

The day after vaccination EMS was called to the patients home EMS States: Pt had right sided gaze noted possibly for the past 2 days. upon EMS arrival pt had tonic clonic seizure activity x3, family denies history of seizures. 12 lead EKG showed afib RVR. Pt was stoke activated and transported to the hospital.

2 days after receiving the vaccine started having a headache and odd visual changes - lights in sparkly patterns, seeing something move in periphery of vision that wasn't there. No fever, no aches, arm didn't hurt, no nausea, was able to continue working so no change in mental status. Lasted until 1/23/2021 and stopped completely. Is asymptomatic now.

PATIENT WAS MONITORED FOR 15 MINUTES AFTER RECEIVING INJECTION. AFTER LEAVING, RETURNED TO VACCINE POD COMPLAINING OF SWELLING OF TONGUE AND THROAT AND SHORTNESS OF BREATH. EMS EVALUATED PATIENT AND SHE WAS TAKEN TO HOSPITAL WHERE SHE WAS TREATED FOR ANAPHYLAXIS AND RELEASED.

Client reported that she had "decreased eyesight" around noon on the day she received her vaccination.

On 3-2-21, my mother noted vision in her right eye was unclear and wavy. On 3-4-21, she woke up in the morning and had lost all sight in the right eye. The examining eye doctor stated there appeared to be a "blister" behind the eye and she was sent to an retinologist for further evaluation on 3-5-21. The retinologist instructed her to go to the ER. My mother was admitted for futher evaluation. Her protime in the ER was 1.7. MRI of head was otherwise negative for changes. Her protime had been stable between 2.0 and 3.0 for years. At her follow-up appointment with her doctor, her protime was 1.8. Her Coumadin dose has been adjusted,

Patient stated that after her first vaccine she has had some vision loss and does not want the second dose.

Swelling in mouth, bottom lip, and tongue, sore throat Itching on entire body and head Rash on entire body --looks like sunburn PCP prescribed-- Prednisone 10mg tab--12 day course on 04/5/21 Betamethasone valerate 0.1% ointment on 03/25/21 Patient claims to be recovering

5/18/21 9:20pm - c/o general aches & soreness right arm 5/19/21 6:10pm - c/o general aches, sleepiness, soreness to right arm temp 99.8 5/20/21 11:21pm - redness adminstration site, redness & puffiness to eyes & face, arm very sore 5/21/21 11:02am - c/o pain at injection site, red, warm, swollen, afebrile 5/21/21 10:03p - arm red, warm, swollen at injection site, afebrile, states feels better today 5/25/21 4:27am - lethargic, tremoring, nausea, diarrhea, temp 103.4 pulse 128, SPO2 82%, sent to hospital

Rash and itching developed over arms, legs, neck, trunk, stomach, crotch, scalp. Persisted for weeks and would not abate with several prednisone treatments. Blisters arose at each point of irritation along with red splotches. Begins with burning, then itching, followed by visual eruption. Inflamed sites are hot and swollen. About 15-25% of body affected at any given time, mostly upper body and arms. Rashes moved over time to various locations. Patient began to feel badly around June 15 2021, with symptoms including: extreme weariness, novel tinnitus, severe itching an burning at night, novel severe brain fog and confusion, inability to drive or accomplish household tasks, novel ocular migraines/loss of vision, headache, loss of appetite.

On 1/14/2021 @ 0659, patient was noted to be weaker, arms were flaccid R>L. Unable to answer questions speech gargled. Unable to grasp hands. Pupils reactive, but sluggish. Probable CVA. Dr. and family were notified. Family wished to keep patient at hospital and provide comfort care rather than send to the hospital. MD was in agreement. APNP, assessed patient. Her tongue was red and swollen. Bite marks noted on right side of tongue likely d/t event. ST evaluation done to evaluate patient's ability to chew and swallow safely due to swelling of tongue. Hospice services were initiated. (Unsure if event was caused by vaccine administration)

Received 2nd vaccine 3/9 one week after vaccine developed. Multiple kanker sores in right side inner oral mucosa and right side facial swelling temp 98.4 improving today facial swelling and lesions are decreasing. We contacted dentist and primary care physician by phone sent pictures of mouth to dentist. Received advice for treatment.

pt says her throat started burning immediately after taking the vax and she had some difficulty swallowing. her PCP came and checked her vitals. She was observed for about 30 minutes and was able to leave. About 4 or 5 days later she noticed her vision declining. She already has poor vision but seemed to be getting worse. She has a varicose vein on her right leg and her upper right leg is swollen. She will contact her doctors.

Vaccinated at about 9:50am Five minutes after vaccination, complained of itchy or "dry" throat. Gave water. 10 minutes after vaccination complained of throat beginning to close up. 10:01am given 0.3mg Epinephrine into right thigh. 911 called. 10:03 given 25mg Diphenhydramine oral tablet. 10:06am pulse 90 BPM. 10:09 pulse 96 BPM. She started to feel better by the time EMS arrived. 10:16am EMS took her to Hospital. She was returned home in the afternoon. Unknown if any further complications.

States had felt her heart beating fast, had a swollen tongue and a weird feeling. PHN checked BP and was 142/84, pulse 94 apically, O2 sats 94% on RA. Patient stated that the feeling lasted for just a minute. PHN gave juice to patient after checking vitals and she stated she felt much better. Asked if would like some Benadryl and she said she took an allergy medication this morning as part of her normal routine. Patient also stated she has a history of an irregular heart rhythm. She stated she ate well for breakfast this morning to ensure she did not have a low blood sugar while waiting for her shot. Note time of incidence at 1139am and had not eaten since breakfast. Patient stated she was fine to go home after her 30 minute wait time. Her VS were good at this time. PHN requested that patient contact her PCP if there were any further concerns following her leaving the site for the vaccination.

My mom received her first Moderna Vaccine on 1/22/21. Late on 1/23 her face began to swell so the staff called the ambulance to come take her to the hospital for what they thought was an abscessed tooth. ER doctor said there was an infection and that she needed to be seen by an oral surgeon. On 1/25/21 I took my mom to Dr., her oral surgeon and after the examination he advised that there was no abscess but an allergic reaction to the Moderna vaccine. He suggested Benadryl. I gave her benadryl and the swelling started subsiding. From this point on her gums and teeth hurt. Her eating habits started to decline. She received her 2nd Moderna vaccine on 2/19/21 and from that point on she could no longer chew or brush her teeth because the pain was so severe. She passed on 3/19/21.

PATIENT REPORTED HIVES AND LIP SWELLING ON 7/23/21. PATIENT IS FOLLOWING UP WITH PRIMARY CARE PROVIDER FOR TREATMENT.

RN administered vaccine in drive through setting and asked pt to park and wait for 15 min. following vaccination. She done so and after 15 minutes she left the facility. Right after that, on her way home, she began to have trouble swallowing, her lips were numb, and her tongue was tingling. She was brought back to the clinic by her caregiver and evaluated by EMS. She was given oral benadryl per patient and held for monitoring. After this, patients symptoms began to improve and everything went back to normal. She was released from EMS care back home.

Looked like she had a stroke; Muscle pain; Disabled; Brain does not work with her body; She cannot use her legs; Swelling of hands and feet; Nausea; Felt Sick (After First Vaccine); Slurring words; Throwing up; Fever 100.3 F (After First Vaccine); Loss of Taste (After First Vaccine); Pain in arm; Redness in arm; Chills; This spontaneous case was reported by a consumer (subsequently medically confirmed) and describes the occurrence of DISABILITY (Disabled), CEREBROVASCULAR ACCIDENT (Looked like she had a stroke), CEREBRAL DISORDER (Brain does not work with her body), MALAISE (Felt Sick (After First Vaccine)), DYSARTHRIA (Slurring words), LOSS OF CONTROL OF LEGS (She cannot use her legs) and NAUSEA (Nausea) in a 98-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 016M20A and 029A21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below. No medical history was provided by the reporter. On 04-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 04-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On an unknown date, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) at an unspecified dose. On 02-Feb-2021, the patient experienced VACCINATION SITE PAIN (Pain in arm), VACCINATION SITE ERYTHEMA (Redness in arm) and CHILLS (Chills). On 04-Feb-2021, the patient experienced AGEUSIA (Loss of Taste (After First Vaccine)) and PYREXIA (Fever 100.3 F (After First Vaccine)). On 03-Mar-2021, the patient experienced CEREBROVASCULAR ACCIDENT (Looked like she had a stroke) (seriousness criteria hospitalization and life threatening), MALAISE (Felt Sick (After First Vaccine)) (seriousness criterion medically significant), DYSARTHRIA (Slurring words) (seriousness criterion medically significant), NAUSEA (Nausea) (seriousness criterion medically significant) and VOMITING (Throwing up). On 04-Mar-2021, the patient experienced LOSS OF CONTROL OF LEGS (She cannot use her legs) (seriousness criterion medically significant) and PERIPHERAL SWELLING (Swelling of hands and feet). On 14-Apr-2021, the patient experienced CEREBRAL DISORDER (Brain does not work with her body) (seriousness criterion medically significant). On an unknown date, the patient experienced DISABILITY (Disabled) (seriousness criterion disability) and MYALGIA (Muscle pain). On 16-Feb-2021, VACCINATION SITE PAIN (Pain in arm), VACCINATION SITE ERYTHEMA (Redness in arm) and CHILLS (Chills) had resolved. On 25-Feb-2021, AGEUSIA (Loss of Taste (After First Vaccine)) and PYREXIA (Fever 100.3 F (After First Vaccine)) had resolved. On 14-Apr-2021, PERIPHERAL SWELLING (Swelling of hands and feet) had resolved. At the time of the report, DISABILITY (Disabled), CEREBROVASCULAR ACCIDENT (Looked like she had a stroke), CEREBRAL DISORDER (Brain does not work with her body), DYSARTHRIA (Slurring words), LOSS OF CONTROL OF LEGS (She cannot use her legs), NAUSEA (Nausea), MYALGIA (Muscle pain) and VOMITING (Throwing up) outcome was unknown and MALAISE (Felt Sick (After First Vaccine)) had resolved. For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments. Based on the current available information and temporal association between the use of the product and the start dates of the event, a causal relationship cannot be excluded. This case was linked to US-MODERNATX, INC.-MOD-2021-076475 (E2B Linked Report). Most recent FOLLOW-UP information incorporated above includes: On 21-Apr-2021: stroke, on hospice. On 22-Apr-2021: Additional info; Sender's Comments: Based on the current available information and temporal association between the use of the product and the start dates of the event, a causal relationship cannot be excluded. US-MODERNATX, INC.-MOD-2021-076475:CROSS LINKED WITH DOSE 2

Swelling of tongue and throat, red itchy area on Left collar bone. Dr prescribed Benadryl and Prednisone 60mg 1xday for 5 days. Symptoms started around 9pm in the evening of same day as vaccine was given.