Moderna

Nervous system symptom reports

Male, 16 - 25 years

Age Reported Symptoms Notes
16 2021-01-25 pain in extremity age under 18; sore arm for day 1 post vaccine only, completely resolved by day 2
16 2021-02-17 pain in extremity Patient received a Moderna vaccine under 18 years old. No adverse effects occurred. Only had a sore ... Read more
Patient received a Moderna vaccine under 18 years old. No adverse effects occurred. Only had a sore arm for 2-3 days. Parent states she will notify the HCP.
16 2021-03-31 pain in extremity 16 years of age - Moderna vaccine. Off label use, less than 18 years of age. Phone call to client'... Read more
16 years of age - Moderna vaccine. Off label use, less than 18 years of age. Phone call to client's mom. Reports client is doing well, just fine. Reports he had an achy arm and was tired for a couple of days, but that was it. States, "he is just fine."
16 2021-04-11 pain in extremity Sore right arm for 1-2 days.
16 2021-04-11 pain in extremity Patient who received vaccination was 16 years old. Interviewed dad. reports that patient had a mild... Read more
Patient who received vaccination was 16 years old. Interviewed dad. reports that patient had a mildly sore arm for a day and denies any other side effects, issues, or concerns.
16 2021-04-27 pain in extremity REPORTING BECAUSE PATIENT 16 YRS OLD, WHICH IS LESS THAN THE RECOMMENDED AGE OF 18 YRS. PATIENT HAD... Read more
REPORTING BECAUSE PATIENT 16 YRS OLD, WHICH IS LESS THAN THE RECOMMENDED AGE OF 18 YRS. PATIENT HAD MINOR SORE ARM FOR 2 DAYS FOLLOWING VACCINATION
16 2021-04-29 grand mal seizure Absence Seizure Tonic Clonic Seizure
16 2021-05-04 tenderness Pt c/o achiness and tender arm as expected after vaccine but vaccine is not approved for patient's u... Read more
Pt c/o achiness and tender arm as expected after vaccine but vaccine is not approved for patient's under the age of 18.
16 2021-05-19 pain in extremity, weakness ADMINISTRATION ERROR: Father claims that they went there on Monday to get the Pfizer vaccine and th... Read more
ADMINISTRATION ERROR: Father claims that they went there on Monday to get the Pfizer vaccine and they ran out, and was scheduled to come back yesterday 5/19/21 and was administered the Moderna in error. He then received the vaccine. He is not as energetic as normal, lethargic, sitting, resting, no activity, very tired, sore arm, maybe low grade fever. The facility did not tell them anything to do about giving him the wrong vaccine, father said very cavalier. They told them to come back in 28 days on 6/16/21 for the 2nd vaccine of Moderna. The facility supposedly reported the error. Father states that the facility told him that the Moderna vaccine was going to be approved very shortly, there were no issues with it, they are all the same, and that he should not have any side effects, and to return to get the 2nd Moderna shot in 28 days.
16 2021-05-31 pain in extremity The patient is 16 yo, given Moderna as an error. F/U with patient: no fever, no headache, no swellin... Read more
The patient is 16 yo, given Moderna as an error. F/U with patient: no fever, no headache, no swelling in the Right arm, only pain controlled with Tylenol
17 2021-01-10 pain in extremity slight sore arm
17 2021-01-22 pain in extremity, numbness Pt presented to Primary Care 1/22/21 for evaluation left arm numbness and pain after reportedly rec... Read more
Pt presented to Primary Care 1/22/21 for evaluation left arm numbness and pain after reportedly receiving vaccine the previous day 1/21/21. Symptoms were improving, and appeared consistent with localized reaction. Concern is that Pt was underage for this vaccine at time of administration. Home living agency was contacted, and reported Pt received vaccine at associated agency. This provider does not know lot # and dose administered. The agency PA has been contacted, and is aware of error- would be reporting to county health.
17 2021-02-07 pain in extremity Sore arm only for 24 hours. Given shot 6 days prior to 18th birthday
17 2021-03-10 pain in extremity sore arm
17 2021-03-24 pain in extremity 17 year old male, (will be 18 on 04/02/2021) - student, volunteered at COVID vaccination event - par... Read more
17 year old male, (will be 18 on 04/02/2021) - student, volunteered at COVID vaccination event - parents wanted student vaccinated - his father is a cancer patient undergoing stem cell transplant - he needs vaccine to be able to see his father . Parents want pt to proceed with 2nd vaccination (he will be 18 at that time) No adverse events - minimal arm soreness
17 2021-03-28 pain in extremity patient was not yet 18 years old. he will be 18 when his 2nd dose is indicated. no issues to repor... Read more
patient was not yet 18 years old. he will be 18 when his 2nd dose is indicated. no issues to report other than sore arm and back.
17 2021-04-06 pain in extremity Only had sore arm for 1 1/2 days. Filling out VAERS as patient was only 17 years 6 months old at the... Read more
Only had sore arm for 1 1/2 days. Filling out VAERS as patient was only 17 years 6 months old at the time of the vaccination.
17 2021-04-07 pain in extremity Client under the age of 18 at time of receiving vaccination. Parent and client called. Both state: ... Read more
Client under the age of 18 at time of receiving vaccination. Parent and client called. Both state: "feeling fine, except a sore arm." Medical Director Notified.
17 2021-04-11 pain in extremity Patient was given first dose of vaccination. Pt was not yet 18 years old. Mother was contacted by p... Read more
Patient was given first dose of vaccination. Pt was not yet 18 years old. Mother was contacted by phone within hours of vaccinations. Mother was advised that pt was given vaccine before 18 years of age and vaccine is not indicated for patients under 18. Mother was with patient when given vaccine and mother indicated she wanted patient to be vaccinated. I gave follow up call the next day to verify how patient was doing. Patient said he was doing fine with the exception of a sore arm.
17 2021-04-13 pain in extremity Sore arm on 1st day.
17 2021-04-14 pain in extremity Received 1st dose of Moderna at age 17 yo-no adverse side affects per discussion with mom. Only had ... Read more
Received 1st dose of Moderna at age 17 yo-no adverse side affects per discussion with mom. Only had a sore arm as expected.
17 2021-04-18 pain in extremity vaccine given at age 17 years. This person had sore arm and slight fever per mom.
17 2021-04-19 pain in extremity PATIENT RECEIVED HER 1ST VACCINE ON 3/23 REPORTING SLIGHT FATIGUE AND SORE ARM AT THE INJECTION SITE... Read more
PATIENT RECEIVED HER 1ST VACCINE ON 3/23 REPORTING SLIGHT FATIGUE AND SORE ARM AT THE INJECTION SITE. SECOND SHOT WAS COMPLETED AND PATIENT WAS ADVISED TO FOLLOW UP WITH PEDIATRICIAN. PATIENT WAS ACCOMPANIED BY MOTHER FROM THE FACILITY.
17 2021-04-20 pain in extremity vaccine given to under age requirement, just a sore arm the next day
17 2021-04-21 pain in extremity It was discovered after the administration of the vaccine was given to Trenton when he was 17 years ... Read more
It was discovered after the administration of the vaccine was given to Trenton when he was 17 years and 4 months old. He did not experience any side effects due to the vaccine other than a sore arm. After consulting the CDC Covid-19 Vaccine Administration Errors and Deviations we told the patient we would administer the 2nd dose to complete the series.
17 2021-04-25 pain in extremity Patient was given a vaccination of COVID 19 vaccine (Moderna), he's only 17 years old and 9 months. ... Read more
Patient was given a vaccination of COVID 19 vaccine (Moderna), he's only 17 years old and 9 months. Indication for this vaccine is 18 years old and older. Discrepancy was discovered during billing. Patient mother was immediately informed, per mother there were no adverse effects other than a sore arm. Mother is only concerned about the second dose (to vaccinate or not). A call was placed to the doctor, she was informed about the incident. She stated that a trial is being done to 12 -18 years now, and was not so concern since the patient is almost 18. However, she will inquire to one of her colleague regarding the recommendation to vaccinate or not for the second dose.
18 2021-01-02 pain in extremity, tingling Tactile fever ,arm pain, headache and malaise in 24 hrs following injection Next day generalized ac... Read more
Tactile fever ,arm pain, headache and malaise in 24 hrs following injection Next day generalized achiness ,retrosternal chest pain and bilateral forearm tingly pain similar to Nov 2019 and went to Hospital UC,CXR and EKG normal but with short PR interval on EKG ,elevated troponin 3.5 Transferred to hospital troponin 12.1 ng/ml IVIG given SARS IGG positive on admission PCR negative
18 2021-01-06 weakness, cold sweat, feeling hot Was nervous about getting the shot. Felt clammy and hot. Felt weak and had a headache. A Code was ... Read more
Was nervous about getting the shot. Felt clammy and hot. Felt weak and had a headache. A Code was called and he was transported to the emergency room for monitoring.
18 2021-01-18 muscle twitching About two weeks after I received the vaccine (almost a week ago as of present) I began experiencing ... Read more
About two weeks after I received the vaccine (almost a week ago as of present) I began experiencing rapid muscle twitches near the injection site. I can send a video if necessary. Only muscle experiencing these symptoms is one on my left shoulder, where the injection occurred. Twitches a couple times a second for a couple minutes at a time. Frequency of these events per day has increased over the past week. Presents without pain, numbness, tingling, etc. No past history of chronic muscle twitches. I am capable of fine motor movements such as writing and maintaining full motion of my arm while it occurs. Consulted with a doctor (my employer) informally and they recommended I submit this form. Willing to answer any questions that might show up.
18 2021-01-20 difficulty speaking Change in voice and O2 SATs dropped- throat was closing
18 2021-01-27 weakness SWOLLEN RIGHT SIDE OF FACE, RIGHT SIDED WEAKNESS,
18 2021-01-28 tremor 01/29/21 early AM shaking, fever chill, cough, fatigue.
18 2021-02-09 pain in extremity Sore shoulder/arm - lasted about a day and a half
18 2021-02-19 migraine, feeling cold malaise, exhaustion, aching, sore, chills, fever, headache, nausea, migraine
18 2021-02-24 depressed level of consciousness WITHIN 5 MINUTES OF VACCINE PATIENT FELT FAINT, LIKE HIS HEAD WAS SPINNING. BP WAS 80/40. PULSE WAS... Read more
WITHIN 5 MINUTES OF VACCINE PATIENT FELT FAINT, LIKE HIS HEAD WAS SPINNING. BP WAS 80/40. PULSE WAS 42. BLOOD SUGAR WAS 125. VERY PALE, LIPS WERE PALE/BLUISH IN COLOR. HAD A DECREASED LEVEL OF CONSCIOUSNESS. SPO2 WAS 88%, OXYGEN WAS PLACED ON HIM. HE WAS TRANSPORTED TO HOSPITAL VIA EMS
18 2021-02-28 numbness Patient said he got dizzy within minutes of receiving vaccine and that resolved by 10 minutes after ... Read more
Patient said he got dizzy within minutes of receiving vaccine and that resolved by 10 minutes after vaccine. Around 10 minutes after vaccine patient said both his arms felt heavy and numb but he was able to move them and his fingers. Patient had no other symptoms and walked out of pharmacy with his mother.
18 2021-03-03 pain in extremity Moderna COVID-19 Vaccine Sore arm - lasted for about 3 days Slight fever the first night into the ne... Read more
Moderna COVID-19 Vaccine Sore arm - lasted for about 3 days Slight fever the first night into the next day - ended in the evening of the 2nd day
18 2021-03-05 unresponsive to stimuli Developed fatigue, body aches, headache 1 day after vaccination on 3/3. The morning of 3/5 complaine... Read more
Developed fatigue, body aches, headache 1 day after vaccination on 3/3. The morning of 3/5 complained of chest pain. Took Tylenol at 8:30 am. At 10:30 am his family found him unresponsive. EMS was called and he was pronounced dead in the home.
18 2021-03-07 flushing Saturday morning after vaccine was administered: Tennis ball size oblong lump noted between eyebrows... Read more
Saturday morning after vaccine was administered: Tennis ball size oblong lump noted between eyebrows at middle of forehead. Felt "funny", cheeks flushed, no apparent fever (not hot to touch). Lump itself was not red, painful or itchy. it was definitely "noticeable". Headache on the day he received vaccine, but no other reports of headache following. Tends to be anxious and has a history of "passing out" when leaving a dentist's office in the past.
18 2021-03-07 seizure About 3 minutes after patient received immunization, he fainted and had a seizure. Patient was with... Read more
About 3 minutes after patient received immunization, he fainted and had a seizure. Patient was with his parents and he told them he felt like he was going to faint, so his parents stabilized him before it happened. Patient seized for about 10 seconds and then came to alertness. He was made comfortable and given juice and a granola bar after a while because patient had not yet eaten this morning. I monitored patient for about 45 minutes before I felt patient was stable and feeling well enough to leave. Patient left with his parents monitoring him.
18 2021-03-08 unresponsive to stimuli Systemic: Dizziness / Lightheadness-Mild, Systemic: Fainting / Unresponsive-Mild, Additional Details... Read more
Systemic: Dizziness / Lightheadness-Mild, Systemic: Fainting / Unresponsive-Mild, Additional Details: Pt fainted in waiting area shortly after vaccine administration. Quickly became responsive, talkative, and aware. Had patient lie down, elevated feet, gave pt water and potato chips to increase salt intake/ raise bp. Monitored patient for additional 30 minutes. Pt indicated he was feeling much better and left with family members with instructions to monitor him and have pt rest for remainder of the day. Tried to follow up with patient on 3/9, but phone number was out of service.
18 2021-03-17 numbness Received first dose of Moderna vaccine today around 2:30 pm. Reports 2 minutes later, felt left side... Read more
Received first dose of Moderna vaccine today around 2:30 pm. Reports 2 minutes later, felt left side of throat "swell" and was uncomfortable. Also felt mild chest discomfort. Symptoms resolved after about 3 minutes, so he finished his 15 minute observation time, and left the clinic. He returned approximately 15 mins later, and informed the ER MD here in the clinic that his throat swelling and tightness had returned and that he now had and some difficulty breathing. He was answering questions appropriately, appeared in no distress. At 1510 VS taken: BP 122/74, O2 sat 100%, P 73, RR 18. Skin color pink/normal. ER MD advised patient be taken to ER and he called report there. Patient was taken via WC right away to ER with MD, and RN and myself. Anaphylaxis kit brought. But not used. He was stable during transport. In ER he c/o more throat tightness, and it appeared that the left side of his neck was mildly swollen. He then c/o bilateral pedal numbness and also some difficulty breathing. Care was assumed by RN and report was given to her. He was able to call his parents prior and remained stable at the time we departed the ER. NP
18 2021-03-18 flushing After receiving vaccine, patient sat down for the 15 minute observation. He reports about 1-2 minute... Read more
After receiving vaccine, patient sat down for the 15 minute observation. He reports about 1-2 minutes after sitting down feeling flushed, lightheaded. Patient's color pale. EMS on site and took over triage of patient. BP 83/50, P 58-60. Patient reported eating a bar before coming. His blood sugar 111. Patient was given water to drink. BP increased to 100/62, color returning, still pale. He reports feeling better. He stood and sat in a w/c to take to the stretcher for additional observation. Patient ate a pack of peanut butter crackers, drank 1 16.9 oz bottle water, color pink, BP 121/76. Patient says he drove from DIFFRENT STATE to receive his vaccine and is alone. Patient reports feeling better. He was instructed to walk around, he did so without any complications, color remained pink. He says he feels better. After additional 15 minute observation, he was checked out. I instructed if the symptoms come back to pull over and call 911, he verbalized understanding.
18 2021-03-18 pain in extremity Deep soreness in the left arm making it hard to lift the arm
18 2021-03-24 pain in extremity Soar arm
18 2021-03-25 pain in extremity Patient had a headache and a sore arm the following day.
18 2021-03-30 seizure, tremor ABOUT 3 MINUTES AFTER RECEIVING COVID-19 MODERNA VACCINE CLIENT EXPERIENCED WHAT IT LOOKED LIKE SEIZ... Read more
ABOUT 3 MINUTES AFTER RECEIVING COVID-19 MODERNA VACCINE CLIENT EXPERIENCED WHAT IT LOOKED LIKE SEIZURE ACTIVITY. ACCORDING TO MOTHER CLIENT WHO WAS SITTING ON A CHAIR FOR OBSERVATION POST VACCINATION, DROPPED HIS PHONE TO THE FLOOR AND RAISED BOTH OF HIS ARMS UP WITH PALMS OPENED AND STARTED TO SHAKE A LITTLE WITH EYES CLOSED. MOTHER ASKED FOR HELP. WHEN HELP ARRIAVED CLIENT WAS CONSCIOUS AND NO SEIZING ACTIVITY WAS WITNESS. CLIENT LOOKED PALE AND SWEATY.
18 2021-03-30 tremor, tingling Site: Pain at Injection Site-Mild, Systemic: Allergic: Difficulty Breathing-Medium, Systemic: Allerg... Read more
Site: Pain at Injection Site-Mild, Systemic: Allergic: Difficulty Breathing-Medium, Systemic: Allergic: Itch (specify: facial area, extremeties)-Medium, Systemic: Allergic: Rash (specify: facial area, extremeties)-Medium, Systemic: Shakiness-Medium, Systemic: Tingling (specify: facial area, extemities)-Medium, Additional Details: tingling, itching, rash development in his hands
18 2021-04-03 muscle twitching Aside from usual soreness of the site, near constant muscle twitches in nose and/or right thigh that... Read more
Aside from usual soreness of the site, near constant muscle twitches in nose and/or right thigh that were never present before. Just a minor thing that I figured was worth reporting due to it not being a listed side effect.
18 2021-04-06 pain in extremity Sore arm, but got a nasty headache a couple of hours after the shot. Then I sweat enough to have to ... Read more
Sore arm, but got a nasty headache a couple of hours after the shot. Then I sweat enough to have to change shirts twice. I took two ibuprofen 200mg each and slept it off. Woke up symptom-free. However, my arm is still sore.
18 2021-04-07 weakness Patient passed out and fell over. He did not injure himself in the fall. Was out for 1-2 seconds. ... Read more
Patient passed out and fell over. He did not injure himself in the fall. Was out for 1-2 seconds. Was a little light headed and weak as he sat in the chair, but was recovered after 15 minutes. Reported being nervous about needles and failed to eat/drink much earlier in the day.
18 2021-04-07 weakness At 1400 patient received his first shot of Moderna. At 1402 patient complained of dizziness and lig... Read more
At 1400 patient received his first shot of Moderna. At 1402 patient complained of dizziness and lightheaded. Noted patient to be weak and unable to hold his body, leaning for forward. BP sitting at 1404 80/60, HR 68, 02 sat 98% on RA. Patient was placed on Trendelenburg position and BP at 1407 120/60, HR 78, 02 sat 99% on RA and patient was able to verbalized his name, age, today?s date, and location. At 1412 BP lying position 120/70, HR 91, 02 sat 99% on RA and patient at this time stated feeling good also stated usually has the same reaction each time he gets a shot. At 1416 patient was put back in sitting position with BP 110/70, HR 89. At 1418 standing BP 140/68, HR 88, 02 sat 98% on RA. Patient stated father is in the car outside to drive him home. No further treatment needed. Total treatment time was 18min. Patient left at 1420.
18 2021-04-07 flushing After getting vaccinated. Patient felt dizzy and shortness of breath, parking team sat him down in w... Read more
After getting vaccinated. Patient felt dizzy and shortness of breath, parking team sat him down in wheelchair. Medics responded, mouth feels dry. Feels a little light headed. HR 160, BP 130/85 at 9:30am. HR 151, BP 177/94 at 9:35am. Facial flushing. Loss of color in face. Transport to hospital.
18 2021-04-08 cold sweat dizziness/light headed, cold, clammy and sweating in face, fainted, then vomited. Occurred 4 hours a... Read more
dizziness/light headed, cold, clammy and sweating in face, fainted, then vomited. Occurred 4 hours after shot was given.
18 2021-04-09 pain in extremity Very quickly had a headache and got very tired. Eventually an extremely sore arm and clogged sinuses... Read more
Very quickly had a headache and got very tired. Eventually an extremely sore arm and clogged sinuses developed.
18 2021-04-12 pain in extremity Fever -> 100.3, Fatigue, Sore arm of injection, Light soreness around body. Lasted around a day.
18 2021-04-14 unresponsive to stimuli This patient had some dizziness after the shot and was apprehensive in receiving it. He claimed he f... Read more
This patient had some dizziness after the shot and was apprehensive in receiving it. He claimed he felt dizzy and in seconds had slumped off of his chair. He was unresponsive for a few seconds only about 5-10 seconds and we gave him an IM Benadryl as a precaution. He awoke complaining of a funny feeling in the mouth and tongue but had no rash or redness or swelling to indicate an allergic reaction. We decide to monitor closely for an escalation of symptoms but to have a EpiPen handy, and call an EMT unit. His blood pressure was low at first at around 107/68 then quickly come up in about 10 minutes to 130/80. With no other issues we believe he had a vasovagal syncope but wanted the ER to make sure we were correct. I called and checked on him after he was at the ER. and the nurse stated that he was doing very well and that they had seen this happen with the vaccine at other site locations.
18 2021-04-15 unresponsive to stimuli "At 1400 patient in observation, RN vaccinator, noticed young man's head drooped over. RN went over ... Read more
"At 1400 patient in observation, RN vaccinator, noticed young man's head drooped over. RN went over to the patients and tapped his arm. Did not respond to verbal or physical touch. RN called for help. After a few seconds patient responded and opened his eyes. Patient transferred via wheelchair to private area. BO 76/64, diaphoretic. RR appeared normal. Patient stated he did not eat all day. patient stated his throat hurt and felt tight and he had chest pain. Patient agreed to be transported via on-sight ambulance to Medical Center for assessment with brother."
18 2021-04-16 pain in extremity Soreness in arm the day of, and one day after, the injection. Starting two days after the injection:... Read more
Soreness in arm the day of, and one day after, the injection. Starting two days after the injection: consistent fever, 100° F to 102° F, body aching in muscles (specifically legs), and chills throughout body. Most intense waking up and before bed (symptoms usually worsen around 8:00 pm).
18 2021-04-17 weakness pt fainted after receiving 1st dose of Moderna Covid vaccine. Pt fainted approximately 10 minutes a... Read more
pt fainted after receiving 1st dose of Moderna Covid vaccine. Pt fainted approximately 10 minutes after vaccine was administered. Pt came to after 10-15 seconds, and fainted 2nd time after about 90-120 seconds. pt came to after about 10-15 seconds. Pt felt weak, was sweating, had chills. Pt was able to talk, breath and swallow water which pt requested to drink. Pt and mom decided that they would like EMT's to check him out. EMTs brought pt to ER and was released after a couple of hours..
18 2021-04-18 unresponsive to stimuli Systemic: Fainting / Unresponsive-Mild
18 2021-04-19 cold extremities, tingling 18 y/o male reported having blurry vision approx.. 5 minutes after having his 1st dose vaccine. Pt w... Read more
18 y/o male reported having blurry vision approx.. 5 minutes after having his 1st dose vaccine. Pt walked to 15 waiting area prior to felling ill. Pt was siting down and had a syncopal episode lasting 20 seconds. Pt was Pale and cool to the touch. After he gained consciousness pt. stated he felt pins and needles to his legs arms hands and lower back. Pt felt better after gaining consciousness. 911 was called R22 arrived on the scene did an evaluation and obtained a pt. refusal as pt. did not want to go to the hospital.
18 2021-04-19 tremor Pt had a vasovagal response to the vaccine. It happened right after administration. Patient started ... Read more
Pt had a vasovagal response to the vaccine. It happened right after administration. Patient started shaking and closed his eyes. Just a few seconds later he woke up and said something along the lines of, "Oh did I pass out?" I caught him in my arms before he could fall to the floor. The same response where he started aggressively shaking and eyes closed happened a few seconds later. His legs straightened out and his head was headed backward. Again I caught him and stabilized him. Afterward, my 2nd pharmacist stopped over and spoke with him. He seemed to be feeling better, but to ensure the same reaction wouldn't happen again, we had him wait 30 min instead of the standard 15. He sat in his chair and did not have any issues. We offered food but he was not interested. I spoke w/ him again this afternoon via phone and he said he was doing fine. Pt said he has had this type of rxn before w/ previous vaccines.
18 2021-04-20 depressed level of consciousness seemed to almost fall asleep and become unconscious like; hypoglycemia; some fatigue; sore arm at in... Read more
seemed to almost fall asleep and become unconscious like; hypoglycemia; some fatigue; sore arm at injection site; This spontaneous case was reported by a consumer (subsequently medically confirmed) and describes the occurrence of DEPRESSED LEVEL OF CONSCIOUSNESS (seemed to almost fall asleep and become unconscious like) in an 18-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 013A21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below. The patient's past medical history included No adverse event (No relevant medical history reported.). On 02-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 03-Apr-2021, the patient experienced VACCINATION SITE PAIN (sore arm at injection site). On 04-Apr-2021, the patient experienced FATIGUE (some fatigue). On 07-Apr-2021, the patient experienced DEPRESSED LEVEL OF CONSCIOUSNESS (seemed to almost fall asleep and become unconscious like) (seriousness criterion medically significant) and HYPOGLYCAEMIA (hypoglycemia). At the time of the report, DEPRESSED LEVEL OF CONSCIOUSNESS (seemed to almost fall asleep and become unconscious like) and HYPOGLYCAEMIA (hypoglycemia) had resolved and VACCINATION SITE PAIN (sore arm at injection site) and FATIGUE (some fatigue) outcome was unknown. The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown. Concomitant product use was not provided by the reporter. On 03-Apr-2021, patient took Tylenol for the sore arm. On 09-Apr-2021, patient went to his doctor. He got some blood work done. His A1c was fine, his fasting glucose level was fine. Doctor doesn't think it's diabetes but had an episode of hypoglycemia. He also did not rule out possible side effect of the vaccine. He has not had another episode since then. Caller is asking if there have been any other reports of hypoglycemic episodes and also asking if Moderna would recommend getting the second dose given the reaction he had with the first dose. This case was linked ( Linked Report).; Sender's Comments: Based on the current available information and temporal association between the use of the product and the start date of these events, a causal relationship cannot be excluded.
18 2021-04-20 unresponsive to stimuli, flushing Pt. just received first Moderna vaccine dosage. He had just sat down in the observation area when he... Read more
Pt. just received first Moderna vaccine dosage. He had just sat down in the observation area when he began to feel flushed and lightheaded. NP was present and soon afterwards his head went backwards and he syncopized. He was caught by the NP and he was still sitting in the chair. NP proceeded to perform a sternal rub. Pt did not become conscious or aware for approximately 2-3 minutes. He never fell to the ground. On further questioning after patient was responsive, he states that he had not eaten prior to coming for his vaccination. He has only received a handful of vaccines and has never had the flu vaccine so he is unsure of his reaction. As per NP patients face became very pale PE: O2sat-96% on room air BP- 110/86 Pulse 60 Pt is pale in color Pupils slightly dilated Responds to sternal rub only After 2-3 minutes pt is more alert EMS was called but patient who is also here with his father refused to be transported to the ER. Repeat vitals 0pulse ox - 96 % room air BP- 105/65 HR-57 Pt. alert and able to respond to conversation Heart rate regular and easy Lungs CTA bilaterally Respiration regular and easy A/P 1-Gave patient water and 2 juices Symptoms have responded well to water and juice and sitting for a few minutes 2. EMS was called but patient refused to go to the ER 3. Discussed possible side effects of vaccine and when to call 911 or go to the closest ER 4. Patient left for home with father after being observed for 40 minutes
18 2021-04-22 pain in extremity Fever, arm pain and severe swelling to upper lip
18 2021-04-22 tingling Immediately following the injection, pt had syncopal episode with loss of consciousness for approxi... Read more
Immediately following the injection, pt had syncopal episode with loss of consciousness for approximately 15-20 seconds. Pt lowered to floor and placed in trendelenburg. BP 100/43, HR 47 and O2 sats 100%. BP then dropped as low as 56/32. Pt alert and oriented and states that his hands felt tingly. and HR in 40's. Cold compress applied as pt was pale and diaphoretic. BP continued to be alert and oriented. BP increased to 103/50 within 5 minutes of lowest BP and HR of 70. Pt states he is starting to feel better. Within 15 minutes of vaccine, BP increased back to 117/83. Pt sat up and BP 134/75. Pt up to chair and BP 139/71. Pt reports he is feeling much better now. Mother called and after approximately 1 hour drove patient home with patient back to baseline before leaving clinic.
18 2021-04-23 numbness Patient received first dose of Moderna COVID-19 vaccine on 4/7/2021. After vaccine was given, patien... Read more
Patient received first dose of Moderna COVID-19 vaccine on 4/7/2021. After vaccine was given, patient complained of lightheadedness, numbness in hands, light sensitivity, and nausea. Doctors and an RN evaluated patient. BP 96/64, not tachycardic. Mother was driving vehicle. No meds given but patient sent with EMS to ED.
18 2021-04-23 muscle spasms VACCINE CONSENT FORM SHOWS NO ADR, NO SEIZURES OR NEUROLOGICAL CONDITIONS , NO SERIOUS REACTION TO V... Read more
VACCINE CONSENT FORM SHOWS NO ADR, NO SEIZURES OR NEUROLOGICAL CONDITIONS , NO SERIOUS REACTION TO VACCINE IN PAST, PT HAS BEEN EXAMINED BY PROVIDER IN PAST YEAR. AS VACCINE WAS BEING ADMINISTERED THE FATHER WHO ACCOMPANIED HIS SON THE PT SAID THAT THE PT WOULD PASS OUT. THE PT DID NOT CONFIRM NOR DENY THIS, UPON ADMINISTRATION OF VACCINE PT BECAME QUIET, GLASSY EYED AND BEGAN TO GO LIMP. HE RESPONDED TO QUESTIONS UNCLEARLY. THE FATHER RESTRAINED PT FROM BEHIND CHAIR AND I IN FRONT OF HIS KNEES TO PREVENT HIM FROM FALLING TO FLOOR. AFTER APPROXIMATELY 3-4 MINUTES, HIS UPPER BODY MUSCLES SHOOK AND THEN THE LOWER BODY, MAYBE 10 SEC?, THEN HE OPENED HIS EYES AND SEEMED RECOVERED. HE WAS ASKED TO REMAIN IN THAT CHAIR UNTIL HE HAD TOTALLY RECOVERED, WHICH HE ASSERTED APPROX 15 MIN LATER. I REQUESTED THE PT AND HIS FATHER REMAIN ANOTHER 15 TO 20 MIN IN WAITING AREA AND TO CHECK OUT WITH ME BEFORE LEAVING. PT WALKED OUT WITHOUT ASSISTANCE, WITHOUT FALTERING OR DIZZINESS.
18 2021-04-24 tremor patient fainted about 2-3 minutes after receiving the vaccine--lasted only seconds--patient was shak... Read more
patient fainted about 2-3 minutes after receiving the vaccine--lasted only seconds--patient was shaking and pale after recovering--patient was did state they probably should have eaten breakfast that morning and did not--his mom got him some orange juice and a poptart -- we also got him a cool/wet compress for the back of his neck--within 10 minutes his color improved-his shaking subsided and he began feeling much better. he was able to leave with his mother under his own power after 15 - 20 minutes.
18 2021-04-27 numbness, tingling numbness dizzy. tingly. couldnt feel tongue
18 2021-04-28 unresponsive to stimuli, unresponsive to stimuli Systemic: Fainting / Unresponsive-Mild
18 2021-04-29 pain in extremity, feeling hot, tingling PATIENT STARTED FEELING HOT, NAUSEA, TINGLING IN FINGERS AND FEET, HANDS WERE RIGID. HE WAS VERY UPS... Read more
PATIENT STARTED FEELING HOT, NAUSEA, TINGLING IN FINGERS AND FEET, HANDS WERE RIGID. HE WAS VERY UPSET AND CRYING. HE HAD PAIN IN HIS HANDS. EMT THOUGHT HE WAS HAVING A PANIC ATTACK
18 2021-04-30 feeling hot The patient came with his mom due to the fact that he does not due well with needles. He stated that... Read more
The patient came with his mom due to the fact that he does not due well with needles. He stated that he is aware that it is all in his head. I had his mom get him something to eat and drink prior to receiving the shot, while I went over the pre-vaccine questions. She was with him while he received the shot. A few seconds after I gave the shot he began to feel hot. He asked to lie down, but never lost consciousness. We had a yoga mat for him to lay on and placed a fan to cool him down. He laid down for a few minutes, but was able to talk and convey how he was feeling. He sat up maybe 5 min later and remained in the cubicle for a few more minutes. He again stated that it was all in his head and that he didn't even feel the needle.
18 2021-04-30 flushing, tingling About 3 minutes after receiving the vaccine, patient complained of loss of vision, ringing in ears, ... Read more
About 3 minutes after receiving the vaccine, patient complained of loss of vision, ringing in ears, lightheadedness, tingling in arms. Pt was diaphoretic and flushed. Pt was taken on a wheel chair to a gurney where they were assessed and vitals recorded. Patient was given some drinking water and symptoms resolved within minutes. Patient was observed for 20 minutes. Pt reported feeling better and fine and walked out of vaccine center on their own.
18 2021-05-04 numbness About 15 minutes after his 2nd vaccine the patient arm went numb and could not grasp anything in his... Read more
About 15 minutes after his 2nd vaccine the patient arm went numb and could not grasp anything in his left ( vaccine) arm.
18 2021-05-05 seizure Multiple seizures that were not common with epilepsy. This occurred for a couple of days after the v... Read more
Multiple seizures that were not common with epilepsy. This occurred for a couple of days after the vaccine.
18 2021-05-08 pain in extremity About 6 hours after the shot, I started getting pain in my arm. 2 hours later, I woke up and was sev... Read more
About 6 hours after the shot, I started getting pain in my arm. 2 hours later, I woke up and was severely shivering for two hours straight. In the morning, I woke up again with a fever of 104 and I dry heaved. My fever broke, but then a few hours later I got another low grade fever. I felt better about 24 hours after my shot.
18 2021-05-08 pain in extremity T+0:00, second COVID shot received. T+2:00, My arm is starting to inflame and firm up. It?s painful,... Read more
T+0:00, second COVID shot received. T+2:00, My arm is starting to inflame and firm up. It?s painful, but bearable. T+5:00, Mild headache, but again bearable T+6:00, Chills and fever set in, headache intensifies, it was around this time I took 400 miligrams of ibuprofen to combat the now throbbing headache. I spent eight hours in bed and I felt fine, but standing up and moving about made my headache come back. T+14:00, I took 400mg of Ibuprofen, drank some water, and decided to try to go to sleep. T+16:30, I woke up with chills, but I managed to go back to sleep. T+20:45, I woke up again, same symptoms, went back to sleep. T+25:15, I woke up and took another 400mg dose of Ibuprofen. T+36:00, This is when I noticed I stopped feeling chills T+48:00, headache symptoms are almost gone.
18 2021-05-11 pain in extremity Passed out; Hallucination; Chest tightness; Sore arm; Headache; This spontaneous case was reported b... Read more
Passed out; Hallucination; Chest tightness; Sore arm; Headache; This spontaneous case was reported by a consumer (subsequently medically confirmed) and describes the occurrence of LOSS OF CONSCIOUSNESS (Passed out) and HALLUCINATION (Hallucination) in an 18-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 039B21A and 008B21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below. No Medical History information was reported. On 30-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 29-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 29-Apr-2021, the patient experienced LOSS OF CONSCIOUSNESS (Passed out) (seriousness criterion hospitalization), HALLUCINATION (Hallucination) (seriousness criterion hospitalization), CHEST DISCOMFORT (Chest tightness), PAIN IN EXTREMITY (Sore arm) and HEADACHE (Headache). At the time of the report, LOSS OF CONSCIOUSNESS (Passed out), HALLUCINATION (Hallucination), CHEST DISCOMFORT (Chest tightness), PAIN IN EXTREMITY (Sore arm) and HEADACHE (Headache) outcome was unknown. Patient was hospitalized due to vehicular accident Concomitant product use was not provided by the reporter. No treatment information was provided. The patient received both scheduled doses of mRNA-1273 prior to the events, therefore action taken with the drug in response to the events was not applicable. Based on current available information and the temporal association between product use and the start date of the events a causal relationship cannot be excluded.; Sender's Comments: Based on current available information and the temporal association between product use and the start date of the events a causal relationship cannot be excluded.
18 2021-05-14 weakness ABOUT AN HOUR AFTER THE SHOT, TIRED AND WEAK. ARM SORE. NEXT DAY WEAK, DIZZY, COULDN'T GET FULL BRE... Read more
ABOUT AN HOUR AFTER THE SHOT, TIRED AND WEAK. ARM SORE. NEXT DAY WEAK, DIZZY, COULDN'T GET FULL BREATH....NEEDED BREATHING TREATMENTS ALL DAY, HARD TO LIFT ARM, TRIED TO WALK BUT FAINTED AND CRASHED INTO A WALL.
18 2021-05-14 pain in extremity, feeling hot Sore arm, Fever, Headache, Fatigue, Trouble sleeping, Feeling very hot, Unwillingness to eat
18 2021-05-14 unresponsive to stimuli Systemic: Dizziness / Lightheadness-Medium, Systemic: Fainting / Unresponsive-Medium, Systemic: Naus... Read more
Systemic: Dizziness / Lightheadness-Medium, Systemic: Fainting / Unresponsive-Medium, Systemic: Nausea-Medium, Additional Details: paramedics came to check out patient and he was ok
18 2021-05-19 flushing Systemic: Dizziness / Lightheadness-Mild, Systemic: "passed out" but was never unresponsive - said h... Read more
Systemic: Dizziness / Lightheadness-Mild, Systemic: "passed out" but was never unresponsive - said he felt very faint while sitting in the observation chair-Mild, Systemic: Flushed / Sweating-Mild, Additional Details: BP and HR were normal for pt. - he laid on the floor for ~10-15 minutes and then stayed seated for additional time and had someone come pick him up as he didn't feel comfortable driving. He stated he hadn't eaten anything this mornign before coming to recieve the immunization - he felt fine by the time he left and we checked in with him later in the day and he was still feeling fine
18 2021-05-19 grand mal seizure not going to receive 2nd dose; tonic-clonic seizure/intense seizure; This spontaneous case was repor... Read more
not going to receive 2nd dose; tonic-clonic seizure/intense seizure; This spontaneous case was reported by a consumer and describes the occurrence of GENERALISED TONIC-CLONIC SEIZURE (tonic-clonic seizure/intense seizure) in an 18-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 025B21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below. The patient's past medical history included Seizure (1st time he had seizure when he took Benadryl 10 month ago when he was 17 year old).). Concurrent medical conditions included Autism. Concomitant products included LORATADINE (CLARITINE) for an unknown indication. On 20-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 05-May-2021, the patient experienced GENERALISED TONIC-CLONIC SEIZURE (tonic-clonic seizure/intense seizure) (seriousness criterion medically significant). On an unknown date, the patient experienced INCOMPLETE COURSE OF VACCINATION (not going to receive 2nd dose). At the time of the report, GENERALISED TONIC-CLONIC SEIZURE (tonic-clonic seizure/intense seizure) outcome was unknown and INCOMPLETE COURSE OF VACCINATION (not going to receive 2nd dose) had resolved. No treatment details provided The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown. No treatment medication information was provided. The patient was on testing at the time of report. Company comment: Very limited information regarding this event has been provided at this time. Further information has been requested. Causal relationship cannot be excluded for the event of Generalised tonic-clonic seizure. Company causality for Incomplete course of vaccination was assessed as not applicable.; Sender's Comments: Very limited information regarding this event has been provided at this time. Further information has been requested. Causal relationship cannot be excluded for the event of Generalised tonic-clonic seizure. Company causality for Incomplete course of vaccination was assessed as not applicable.
18 2021-05-20 cold sweat Patient got nauseous and clammy post vaccination. He was nervous and worked up prior to. We put his... Read more
Patient got nauseous and clammy post vaccination. He was nervous and worked up prior to. We put his feet up and gave him some water. He felt better in 15 minutes and went back to work.
18 2021-05-20 feeling hot, feeling cold Extreme Nausea (48 hours), Loss of appetite (48 hours), Hot & Cold Chills.
18 2021-05-20 seizure Patient received dose 1 of Moderna vaccine on 5/8/2021 and had witnessed seizure 5/12/2021- (first t... Read more
Patient received dose 1 of Moderna vaccine on 5/8/2021 and had witnessed seizure 5/12/2021- (first time ever). He was admitted to ICU on 5/12/2021 and discharged 5/15/2021. He states he had one seizure while in the ICU and another seizure 5/16/2021- at home after discharge. He has since been placed on anti-seizure medications and is scheduled for follow up with neurology on 6/2/2021. Patient's mother states ICU doctors told her they found a blood clot in the brain picked up by MRI.
18 2021-05-20 unresponsive to stimuli, flushing, tremor Systemic: Fainting / Unresponsive-Mild, Systemic: Flushed / Sweating-Mild, Systemic: Shakiness-Mild,... Read more
Systemic: Fainting / Unresponsive-Mild, Systemic: Flushed / Sweating-Mild, Systemic: Shakiness-Mild, Additional Details: mother informed rph prior to shot that patient exhibits these reactions after receving shots. mother and rph held pt. he fell on his buttocks but was unhurt while changing location. rph had advised mother to keep him sitted. we fanned him to cool his sweating. he drank 2boxes of juice. he left after 15minutes.
18 2021-05-21 involuntary muscle movements, nerve pain, muscle spasms Patient reported headache, muscle spasms in right arm, jerking muscles, and nerve pain in the right ... Read more
Patient reported headache, muscle spasms in right arm, jerking muscles, and nerve pain in the right arm. Primary care provider prescribed Cyclobenzaprine 10mg three times per day as needed for muscle spasms and Tramadol 50mg every 6 hours if needed for pain.
18 2021-05-21 feeling hot Not feeling well; Feels hot; Achiness all over; Chills; inadvertently given the Moderna vaccine (2n... Read more
Not feeling well; Feels hot; Achiness all over; Chills; inadvertently given the Moderna vaccine (2nd dose); This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION COMPLICATION (Not feeling well), FEELING HOT (Feels hot), MYALGIA (Achiness all over) and CHILLS (Chills) in an 18-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 044B21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below. No medical history was provided by the reporter. On 10-May-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 10-May-2021, the patient experienced WRONG PRODUCT ADMINISTERED (inadvertently given the Moderna vaccine (2nd dose)). On 11-May-2021, the patient experienced VACCINATION COMPLICATION (Not feeling well) (seriousness criterion medically significant), FEELING HOT (Feels hot) (seriousness criterion medically significant), MYALGIA (Achiness all over) (seriousness criterion medically significant) and CHILLS (Chills) (seriousness criterion medically significant). On 10-May-2021, WRONG PRODUCT ADMINISTERED (inadvertently given the Moderna vaccine (2nd dose)) had resolved. At the time of the report, VACCINATION COMPLICATION (Not feeling well), FEELING HOT (Feels hot), MYALGIA (Achiness all over) and CHILLS (Chills) outcome was unknown. The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown. No concomitant medications and lab values were reported. No treatment related information has been reported. This report refers to a case of wrong product administered for mRNA -1273, lot # 044B21A with AEs. Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded.; Sender's Comments: This report refers to a case of wrong product administered for mRNA -1273, lot # 044B21A with AEs. Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded.
18 2021-05-23 pain in extremity, weakness Fever, chills, body aches, dizziness, sore left arm, weak body, brain fog - these signs lasted from ... Read more
Fever, chills, body aches, dizziness, sore left arm, weak body, brain fog - these signs lasted from 9:30 PM, Tuesday 5/18/21 through 6:00 PM , Wednesday 5/19/21. On Monday, 5/24/2021, patient experienced 2 bloody noses. One when he woke up at 7:30 AM and then another at 5:15 PM. Bloody noses are not normal for him.
18 2021-05-24 facial paralysis, bell's palsy half of face is drooping., bell palsy
18 2021-05-24 facial paralysis, bell's palsy Right facial paralysis started over the weekend and was diagnosed as Bell's Palsy by me in the offic... Read more
Right facial paralysis started over the weekend and was diagnosed as Bell's Palsy by me in the office on 5/25/21. Prednisone and artificial tears were ordered. Referral made to ophthalmologist and neurologist for further treatment recommendations.
18 2021-05-26 discomfort Major abdominal pain. Large amounts of extremely painful gas. Wailing in pain. Difficult to find com... Read more
Major abdominal pain. Large amounts of extremely painful gas. Wailing in pain. Difficult to find comfort.
18 2021-05-27 seizure Adverse event reported by patient's mother. Patient with severe autism disorder and partial complex ... Read more
Adverse event reported by patient's mother. Patient with severe autism disorder and partial complex epilepsy disorder. Patient had a breakthrough seizure about 3 hours after first moderna vaccination. Seizure lasted approximately 3 minutes per mother, who is his caretaker. Patient recovered to baseline after the seizure. Unknown if any medications were given. Mother did not have the patient evaluated in a clinic or ER after the event. Adverse event was not known until patient presented for the second vaccination, at which point, second vaccination was delayed.
18 2021-05-31 weakness Dose 1: 4/29/2021 Dose 2: 5/27/2021 Symptoms onset began on 4/28/2021 and included fevers, cough, w... Read more
Dose 1: 4/29/2021 Dose 2: 5/27/2021 Symptoms onset began on 4/28/2021 and included fevers, cough, weakness, heartache, diarrhea, headache, dizziness. Symptoms temporarily improved on 5/29/2021. On 5/30/2021 at approximately 1:00 AM patient experienced constant, pleuritic chest pain/pressure and shortness of breath which prompted him to go to the emergency department.
18 2021-06-02 unresponsive to stimuli The patient was here for his first Moderna vaccine. He did not exhibit any agitation or nervousness.... Read more
The patient was here for his first Moderna vaccine. He did not exhibit any agitation or nervousness. His girlfriend got her vaccine first and was talking to him as he received his. They were discussing how little it hurt when he fell out of his chair. He did not respond when we moved to him, but within five seconds he was awake and asking what happened. He was alert and sat in a chair for 30 minutes with no adverse effects from the fall. He noted he only slept 3 hours the night before the vaccine and had not eaten anything that day. The patient refused any further medical care.
18 2021-06-08 difficulty speaking Severe dry cough, temperate max = 99.4, hoarseness, headache, insomnia
18 2021-06-09 discomfort 4/23/21 at around 1pm, felt pain in left shoulder blade and around left upper lung and ribs area. F... Read more
4/23/21 at around 1pm, felt pain in left shoulder blade and around left upper lung and ribs area. Felt like tissues around it was tearing and grinding. After an hour felt pain near heart area and experienced nausia and felt faint. Was taken to hospital around 3pm. Was screened and tested for Covid-19 - negative. XRay was taken - did not show any issues Was given strong anti-inflammatory via shot Was monitored for 2 hours. Sent home. Discomfort improved over the weekend and no longer experiencing any symptoms.
18 2021-06-10 unresponsive to stimuli, seizure, flushing Systemic: Dizziness / Lightheadness-Severe, Systemic: Fainting / Unresponsive-Severe, Systemic: Conv... Read more
Systemic: Dizziness / Lightheadness-Severe, Systemic: Fainting / Unresponsive-Severe, Systemic: Convulsions-Severe, Systemic: Flushed / Sweating-Severe, Systemic: Seizure-Medium
18 2021-06-13 numbness blood pressure and pulse went very high, felt heart palpitations, chest pains on left side of chest,... Read more
blood pressure and pulse went very high, felt heart palpitations, chest pains on left side of chest, left arm and hand went numb
18 2021-06-14 seizure Within 2-3 minutes after injection, patient fainted and had what looked like a brief seizure.
18 2021-06-15 pain in extremity, migraine Upon waking up the next day after the vaccine I experienced out of the ordinary fatigue and arm sor... Read more
Upon waking up the next day after the vaccine I experienced out of the ordinary fatigue and arm soreness. This progressed into a rather severe migraine. As of today, 06/16/2021 at 6:30am I woke up with dizziness and lightheadedness which is again out of the ordinary for me and I believe is attributed to the vaccine.
18 2021-06-16 weakness, concussion Woke up on floor/ Past out; Anxiety; Fall; Little weak; Foggy head; Shiver; Headache; Nausea; Throw ... Read more
Woke up on floor/ Past out; Anxiety; Fall; Little weak; Foggy head; Shiver; Headache; Nausea; Throw up; Concussion; Buzzing in ears; Did not eat; This spontaneous case was reported by a consumer and describes the occurrence of LOSS OF CONSCIOUSNESS (Woke up on floor/ Past out) in an 18-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 033C21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below. No Medical History information was reported. On 01-Jun-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 01-Jun-2021, the patient experienced CONCUSSION (Concussion), TINNITUS (Buzzing in ears), EATING DISORDER (Did not eat), CHILLS (Shiver), HEADACHE (Headache), NAUSEA (Nausea) and VOMITING (Throw up). On 02-Jun-2021, the patient experienced ASTHENIA (Little weak) and FEELING ABNORMAL (Foggy head). On an unknown date, the patient experienced LOSS OF CONSCIOUSNESS (Woke up on floor/ Past out) (seriousness criterion medically significant), ANXIETY (Anxiety) and FALL (Fall). At the time of the report, LOSS OF CONSCIOUSNESS (Woke up on floor/ Past out), CONCUSSION (Concussion), TINNITUS (Buzzing in ears), EATING DISORDER (Did not eat), ASTHENIA (Little weak), FEELING ABNORMAL (Foggy head), ANXIETY (Anxiety), FALL (Fall), CHILLS (Shiver), HEADACHE (Headache), NAUSEA (Nausea) and VOMITING (Throw up) outcome was unknown. DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 01-Jun-2021, Blood glucose abnormal: abnormal (abnormal) abnormal. On 01-Jun-2021, Blood pressure measurement: abnormal (abnormal) abnormal. The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown. Concomitant medications were not reported . Treatment information was not provided. Company comment:Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded.; Sender's Comments: Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded.
18 2021-06-19 feeling hot Patient received vaccine and 10 minutes into waiting period, he began to slouch in chair and he drop... Read more
Patient received vaccine and 10 minutes into waiting period, he began to slouch in chair and he dropped his belongings. We got to him quickly and held him up while it appeared he was fainting. We lowered him to the ground and called 911 and his father that was in store . He complained of being very hot and dizzy. He began to recover fairly quickly, he drank some water and stayed on floor. His dad arrived and the 911 call was cancelled due to his improving awareness. He stayed in the lobby for 20-30 minutes. He felt much better and left with his dad in good physical condition.
18 2021-06-20 migraine Fever, chills, nausea, migraine
18 2021-06-23 tremor, muscle twitching Pt fainted seconds after receiving the 1st Moderna vaccine. Unconscious for approx. 30 seconds, sha... Read more
Pt fainted seconds after receiving the 1st Moderna vaccine. Unconscious for approx. 30 seconds, shaking limbs & facial twitching. Pt came too quickly & mother came to take him home without assistance.
18 2021-06-24 numbness The patient felt dizzy after getting vaccine (about 1 minute). Before getting vaccine he said he fe... Read more
The patient felt dizzy after getting vaccine (about 1 minute). Before getting vaccine he said he felt nervous with the syringe.He said he felt dizzy and his hands are numbing. We let him sit down and drink some water. He felt fine after 15 minutes and he left.
18 2021-06-24 unresponsive to stimuli Systemic: Dizziness / Lightheadness-Mild, Systemic: Fainting / Unresponsive-Mild, Additional Details... Read more
Systemic: Dizziness / Lightheadness-Mild, Systemic: Fainting / Unresponsive-Mild, Additional Details: Patient fainted 8 minutes after administration, came to after a few seconds. Patient was laid supine with legs elevated and EMS was called. Patient stated that he was fine, but was taken by EMS for further evaluation.
18 2021-06-25 pain in extremity Patient is an 18 year old male with history of albinism and bilateral horizontal nystagmus. No othe... Read more
Patient is an 18 year old male with history of albinism and bilateral horizontal nystagmus. No other medical problems. He received the second dose of the Moderna vaccine on 6/15/2021. On 6/21/2021, he developed bilateral thigh/hamstring pain and bilateral pectoral pain that progressively worsened. On 6/24/2021 he noticed red-tinged urine. Patient does not take any medication or OTC supplements. He denies any recent major physical activity or time spent outside.
18 2021-06-30 burning sensation widespread urticarial plaques / hives with associated itching and burning. No associated wheezing /... Read more
widespread urticarial plaques / hives with associated itching and burning. No associated wheezing /respiratory issues
18 2021-07-01 unresponsive to stimuli Systemic: Fainting / Unresponsive-Medium, Additional Details: Pt fainted in waiting area approximate... Read more
Systemic: Fainting / Unresponsive-Medium, Additional Details: Pt fainted in waiting area approximately 2 minutes after administration. felt dizzy, had approx 12 oz water after. remained for 20 min. in waiting area. took bp and was normal just before he left.
18 2021-07-02 tremor, flushing, unresponsive to stimuli, tingling Site: Pain at Injection Site-Mild, Systemic: Chest Tightness / Heaviness / Pain-Mild, Systemic: Conf... Read more
Site: Pain at Injection Site-Mild, Systemic: Chest Tightness / Heaviness / Pain-Mild, Systemic: Confusion-Mild, Systemic: Dizziness / Lightheadness-Mild, Systemic: Exhaustion / Lethargy-Mild, Systemic: Fainting / Unresponsive-Mild, Systemic: Flushed / Sweating-Mild, Systemic: Hypertension-Mild, Systemic: Shakiness-Mild, Systemic: Tingling (specify: facial area, extemities)-Mild, Additional Details: 8 minutes after pt received Moderna vaccine, pt's mother yelled for help because the pt had passed out for a duration of 5-10 seconds then woke up. Pt was administered 1 dose of adult epipen and 911 was called. Once EMT arrived they took him to the hospital to be evaluated. He appeared to recover by demonstrating the ability to stand up walk around and respond to questions asked by the EMT.
18 2021-07-05 numbness, pain in extremity Right arm, R ear pain and dizziness, progressing facial numbness, possible focal seizures or syncope... Read more
Right arm, R ear pain and dizziness, progressing facial numbness, possible focal seizures or syncope. No shortness of breath, difficulty swallowing or rash/hives. BP=129/92, HR=80.
18 2021-07-06 bell's palsy, facial paralysis Left sided facial drooping - started 07/03/2021. Patient diagnosed with Bell's palsy 07/07/2021. Tre... Read more
Left sided facial drooping - started 07/03/2021. Patient diagnosed with Bell's palsy 07/07/2021. Treated with acyclovir 800mg (1 tab orally 5 times a day for 10 days) and prednisone 10mg (7 tabs day 1, decreasing by 1 tab/day until gone)
18 2021-07-07 flushing Systemic: Dizziness / Lightheadness-Mild, Systemic: Flushed / Sweating-Mild, Systemic: Visual Change... Read more
Systemic: Dizziness / Lightheadness-Mild, Systemic: Flushed / Sweating-Mild, Systemic: Visual Changes/Disturbances-Mild
18 2021-07-14 cold sweat PT'S FACE LOSE COLOAR . HE WAS VERY WHITE. HE ALSO HAD COLD SWEAT. HE FELT DIZZY AND HAD RINGING IN... Read more
PT'S FACE LOSE COLOAR . HE WAS VERY WHITE. HE ALSO HAD COLD SWEAT. HE FELT DIZZY AND HAD RINGING IN HIS EARS HE FELT LIKE HE WANTED TO THROW UP. HIS AUNT WANTED US TO CALL AMULANCE. THE PARAMEDIC CAME . ALL THE VITALS WERE NORMAL. HIS FACE COLOR STARTED COMING BACK. PARAMEDIC ALSO CHECKED IF THERE WERE RASHES ON HIS CHEST AND ARMS. NOTHING. PARA MEDIC ASKED PT WHETHER HE WANTED TO GO HOSPITAL, HE DECLINED. HE SAT 10 MORE MINUTES FOR OBSERVATION AND HE FELT WELL ENOUGH AND LEFT.
18 2021-07-14 involuntary muscle movements, depressed level of consciousness Immediately after receiving vaccine, customer appeared to slouch over and I held his head and talked... Read more
Immediately after receiving vaccine, customer appeared to slouch over and I held his head and talked to him as I was unsure if he was just joking in front of his family. He then sat up and indicated he did not remember slouching. I explained to him that his blood pressure probably just went too low and asked him to continue breathing and try to put his head between his legs. He seemed fairly alert but a few seconds later, experienced some body jerking and I asked his father to call EMS, which he did. Customer then seemed to be in a semi alert state and started sweating profusely. I continued talking to him and watched for a fall until the EMS arrived. EMS triaged him and took him from the store. EMS reported systolic blood pressure unmeasurable upon arrival and around 70 at time of taking him from location (approximate numbers)
18 2021-07-19 tingling, unresponsive to stimuli, tremor, flushing, weakness Systemic: Allergic: Anaphylaxis-Medium, Systemic: Fainting / Unresponsive-Medium, Systemic: Flushed ... Read more
Systemic: Allergic: Anaphylaxis-Medium, Systemic: Fainting / Unresponsive-Medium, Systemic: Flushed / Sweating-Medium, Systemic: Hyperventilation-Medium, Systemic: Hypotension-Medium, Systemic: Shakiness-Medium, Systemic: Tingling (specify: facial area, extemities)-Medium, Systemic: Weakness-Medium, Additional Details: Patient was administered vaccine in left deltoid. Patient was seated in chair when vaccinated. Patient walked about 5 or 6 steps to waiting room chair to sit down and wait post vaccination. About 90 seconds to 3 minutes post vaccination the patient was seated in chair and fainted forward. Was holding conversation with father in the next chair to him and fainted from chair to the floor. Patient was aware after about 5 to 7 seconds post fainting, arms and hands were rigid.
18 2021-07-21 pain in extremity Pain in left arm
18 2021-07-22 feeling cold Pt "blacked out" & legs went stiff shortly (within 5 mins of receiving vaccination), pt reported fee... Read more
Pt "blacked out" & legs went stiff shortly (within 5 mins of receiving vaccination), pt reported feeling cold & seeing black spots, emergency personnel was called immediately, water was given & monitored until emergency personnel arrived on site. Patient reported waves of feeling better & worse throughout the course of waiting for emergency personnel. Emergency personnel evaluated patient & transported to local hospital.
19 2021-01-20 pain in extremity Upon checking on resident to obtain vital signs, resident reported "not feeling great." When asked w... Read more
Upon checking on resident to obtain vital signs, resident reported "not feeling great." When asked what resident was feeling, resident stated "my body hurts all over, my arm hurts, I have a headache and I feel like my breathing is weird." Asked resident if he was experiencing SOB and resident stated yes and "it is hard for me to breath." Vital signs included BP 107/76, HR fluctuating between 122-145, O2 ranging from 95-96%, temperature 98.4, RR 19. Took resident to Emergency Department.
19 2021-01-21 numbness, flushing, feeling hot I got the injection at 3:35pm on 1/20 in my left arm. Within the first 30 minutes, my shoulder aroun... Read more
I got the injection at 3:35pm on 1/20 in my left arm. Within the first 30 minutes, my shoulder around the injection site was incredibly sore, my left elbow had a lot of joint pain, and my left thumb and index fingers went numb within the first 30 minutes, I woke up at 8:00am on 1/21 and noticed that I had a light headache, felt extremely groggy, and was experiencing an uncomfortable amount of muscular and joint pain. I went to work at 9:00 and on the drive there, I began to feel dizzy and I felt as if when I turned my head, my vision would lag behind and take a second to process my surroundings. By 10:00, my muscular and joint pains were significantly amplified, my headaches were increasing in frequency and amplitude. I also began to have the chills, followed by periods of radiating heat from my body. Coworkers told me I looked very flushed, however, I never developed a fever. By 11:00, the muscular and joint pains, coupled with the headaches forced me to sit down and I almost broke down into tears. There were three sperate times where I began to get very lightheaded and thought I was going to pass out ( I did not). I went home at noon and noticed that my muscles felt like they were on fire. I took Tylenol and Advil whenever I could, which helped to reduce the symptoms. we had dinner at 7:00, however, I had no appetite, without eating since noon. On 1/22, I woke up at 8:30 with a pounding headache, muscular and joint pains still there, however reduced, and the same groggy feeling. This morning, I also noticed that I had a very sharp stomach pain in my abdomen. I also woke up with a severe nosebleed, which is extremely uncommon for me.
19 2021-01-23 discomfort, tingling On second day after vaccination, Patient began to notice cutaneous lesions on bilateral dorsa of fee... Read more
On second day after vaccination, Patient began to notice cutaneous lesions on bilateral dorsa of feet and both palms. The dorsa of his feet had a slightly raised, pruritic erythematous rash that, over the course of the day, extended in places near to the ankle. Though not warm to the touch, Patient explained that they felt hot and painful. There was slight swelling. By 1/24/21, there was less swelling, and discomfort and the erythematous rash had become eczematous in places and thicker than the previous day. The palms didn't have an appreciable rash. However, Patient felt much discomfort there (not exactly painful) and some paresthesia. He felt that his fingers were swollen. By 1/24/21, the discomfort in both palms was worse.
19 2021-01-24 weakness, migraine Immediately after the vaccine was administered I experienced the usual side effects of mild headache... Read more
Immediately after the vaccine was administered I experienced the usual side effects of mild headache, fatigue and localized redness and swelling Around 11pm the night the vaccine was administered I developed a migraine that resulted in blurred vision. and when I checked my temperature it was approximately 104.9 degrees Fahrenheit.By the next morning, approximately 7am, I was weak to the point I could not get out of bed myself, I was nauseous that resulted in a single Emesis episode approximately 8am, I had mild swelling of my face since 7am, between 7:30am and 12pm, I had multiple times where I would temporarily lose my vision. Throughout 1/25 I continued to have a fever ranging from 102 degrees Fahrenheit to 103 degrees Fahrenheit. At approximately 8am and 1pm I took two acetaminophen pills each time which alleviated the migraine and to an extent helped with the visual deficit episodes. Throughout 1/24 and 1/25 I suffered with extreme chills resulting in shivering that lasted for several minutes despite a room temperature of approximately 90 degrees Fahrenheit and covered in two blankets. PCP was consulted via telephone and she advised to go to the hospital via EMS given the high grade fever, abnormal vitals and severity of symptoms
19 2021-01-27 weakness, pain in extremity Began a few hours after second dose (4-5 hours). Left Arm pain, headache, and fatigue. 1-2 hours af... Read more
Began a few hours after second dose (4-5 hours). Left Arm pain, headache, and fatigue. 1-2 hours after developed chills, joint pain, weakness/fatigue, muscle aches, as well as the previous symptoms.
19 2021-01-27 tremor I was woken up at approximately 2AM January 28th due to the fact that I had sweat through my clothes... Read more
I was woken up at approximately 2AM January 28th due to the fact that I had sweat through my clothes sheets and was shaking. I had severe muscle weakness, a severe headache, and fatigue that has limited my ability to do daily functions. Since 2AM 1500mg of tylenol have been ingested, but my fever holds at 100-101 degrees. Time of writing this document is 11:20AM January 28th.
19 2021-02-08 pain in extremity A few minutes after injection he started complaining of a headache and pain and aching in his hands.... Read more
A few minutes after injection he started complaining of a headache and pain and aching in his hands. This slowly got worse, and we called EMS and he was taken to hospital. We are unsure of treatment at the ER, but he was released the same day with the diagnosis of "arm pain" with no mention of it being an adverse reaction from the vaccine.
19 2021-02-08 tremor I received my first vaccine as the Pfizer manufacturer, and did not have any side effects. However, ... Read more
I received my first vaccine as the Pfizer manufacturer, and did not have any side effects. However, when I received my 2nd shot, I received the Modena manufacturer, and have experienced many concerning side effects. Fever, cold chills, trembling, fatigue, that lasted 2 days after the vaccine was administered. The side effect I am still experiencing is a metallic taste in my mouth, that gets worse when I drink water or other beverages. My hands and fingers turned a rust orange color the day after getting the shot and resolved within 48 hours.
19 2021-02-22 tingling Today around 5:30pm, patient felt he started breathing hard, then felt lightheaded, then had tinglin... Read more
Today around 5:30pm, patient felt he started breathing hard, then felt lightheaded, then had tingling around cheeks, sides of trunk and arms, and then his hands became rigid. All adverse events happened around the same time per patient. Patient had difficulty moving fingers due to hand rigidity. After 10 minutes, all adverse events went away on their own and patient felt back to normal. Patient refused to visit urgent care or emergency room. Instead patient made teledoc appointment for tomorrow and was counseled by doctor if any of the adverse events return that he should promptly visit ER. Patient left after feeling asymptomatic for 15 minutes.
19 2021-02-25 weakness Headache, fatigue, myalgias, dizziness, weakness, abdominal pain
19 2021-02-28 pain in extremity - Uncontrollable Shivering - Fever - Sore left Arm - Tiredness and fatigue - Kept me up at night
19 2021-03-02 numbness Vaccine was administered to patient. Within 10 minutes of administration, the patient had an episod... Read more
Vaccine was administered to patient. Within 10 minutes of administration, the patient had an episode of syncope and fell out of his chair. I immediately went out to help the patient and a technician called for EMS. The patient woke up within 2 minutes and reported feeling dizzy, tired, and numb. While waiting for EMS to arrive, the patient was situated in a sitting position and I continued talking to him to keep him awake. EMS assessed him and took him out to the ambulance to wait for a relative to come. It is unknown if the patient went to the emergency room or not.
19 2021-03-04 bell's palsy Mild bell's palsy of the left face that started 4 days after the vaccine was given
19 2021-03-04 burning sensation Patient started not feeling well the night after receiving vaccine. Next day patient had flu like s... Read more
Patient started not feeling well the night after receiving vaccine. Next day patient had flu like symptoms, headache, anxiety, increased heart rate and trouble breathing. Patient also presented with rash located back of neck and back - red, painful, burning and itching rash - painful to sleep on back the night after receiving the vaccine
19 2021-03-07 tremor Nose is stuffy; Trembling; Metallic taste in mouth; Hands and fingers turned a rust orange color; se... Read more
Nose is stuffy; Trembling; Metallic taste in mouth; Hands and fingers turned a rust orange color; severe body ache; Headache; body chills; fever of 102F; Fatigue; Received first shot of Pfizer vaccine and scond shot of Moderna's; A regulatory authority report was received from a healthcare provider concerning a 19-year-old, male patient who received first shot of Pfizer vaccine and second shot of Moderna's/wrong product administered, headache, nose is stuffy/nasal congestion, chills, trembling/tremor, fever of 102F/pyrexia, hands and fingers turned a rust orange color/skin discoloration, metallic taste in mouth/dysgeusia, fatigue and severe body ache/myalgia. The patient's medical history included allergies to codeine and anxiety. Products known to have been used by the patient, within two weeks prior to the event, included Fluoxetine 40mg, Lamotrigine 100mg, Amlodipine 10mg and Lunesta 3mg. On 01 Feb 2021, approximately one day prior to the onset of the symptoms, the patient received a dose of the mRNA-1273 (Batch number: not provided) intramuscularly in the right arm for prophylaxis of COVID-19 infection. On 01 Feb 2021, the patient went to pharmacy and was offered his second dose of the vaccine, at the time of administration, the patient stated he was unaware that the vaccine given to him was from Moderna. His first vaccine was from Pfizer. On 02 Feb 2021, the patient stated he felt very sick, he had a headache, nose was stuffy, body chills, severe body aches, a fever of 102 degree Fahrenheit, and noted rust colored spots on his hands. The patient stated these symptoms lasted two days after the vaccine was administered. The patient also stated he had a metallic taste in his mouth that worsened when he drank water or other beverages. At the time of this report, the metallic taste in mouth had not resolved. The patient visited Urgent Care and was instructed to take a baby acetylsalicylic acid once a day. Action taken with mRNA-1273 in response to the events was not applicable. The outcome of the event, metallic taste in mouth/dysgeusia, was considered not resolved. The outcome of event, received first shot of Pfizer vaccine and second shot of Moderna's/wrong product administered, were considered resolved on 01 Feb 2021. The outcome of events, headache, nose is stuffy/nasal congestion, chills, trembling/tremor, fever of 102F/pyrexia, hands and fingers turned a rust orange color/skin discoloration, fatigue and severe body ache/myalgia, were considered recovered on 04 Feb 2021.; Reporter's Comments: Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded.
19 2021-03-10 weakness 10 minutes post vaccine administration at 13:15 patient began to exhibit the following symptoms: diz... Read more
10 minutes post vaccine administration at 13:15 patient began to exhibit the following symptoms: dizziness, paleness, weakness, blurred/loss of vision, ringing in the ears, and diaphoresis. Cold pack was placed on patient's forehead and patient's feet were elevated. BP, pulse, & temperature unable to assess, pulse was faint and weak. Patient experienced loss consciousness for 1 minute, 34 seconds. During this time paramedics were called. Vitals at 13:20 were: BP=98/76, P=62, temp= unable to register with machine on hand. Patient able to follow commands and asked to lie down. Cold pack was placed on the back of his neck. Paramedics arrived and assessed patient's blood glucose = 56. Patient given orange juice. Vitals at 13:30 were: BP = 107/69, P = 70, Temp = 97.6., pulse ox: 99%. Patient asked to sit up and vitals were: BP = 114/73, P: 71. Patient declined to go be transported in ambulance with paramedics to the hospital at that time. Blood glucose assessed again = 127. Patient given chips and salsa from what facility had on hand. Patient stayed 10 minutes to eat the snack. Patient instructed to go to the hospital or urgent care for further follow-up and assessment. Patient verbalized understanding and agreed to instruction. Stated he will go to nearest Urgent Care facility. Patient left this facility alert and oriented.
19 2021-03-24 seizure like phenomena After patient received COVID vaccination, he exhibited seizure like activity. Staff moved patient to... Read more
After patient received COVID vaccination, he exhibited seizure like activity. Staff moved patient to floor. 911 was dispatched. Patient complained of nausea. Vomited x2. Skin pale and diaphoretic.
19 2021-03-24 seizure Client was waiting his shot time when he fell from his chair hitting his left shoulder and face. He ... Read more
Client was waiting his shot time when he fell from his chair hitting his left shoulder and face. He appeared to have seizure activity. He became responsive very quickly and was oriented. 911 was called and he was transported to emergency department. He was able to walk to the ambulance.
19 2021-03-26 pain in extremity, tingling, numbness Currently having it. I have a swollen face. Blurry vision. Difficulty standing. Shallow breaths. Hea... Read more
Currently having it. I have a swollen face. Blurry vision. Difficulty standing. Shallow breaths. Headache. Chills. Body aches. 101 fever. Unable to sleep but very tired. Not able to breather through nose. Sore and numb right arm. Tingling of my limbs. Occasionally sharp pain in muscles. I got the shot at 11 and was just fine but I had work. I drove for a little over an hour and progressively my arm got weaker. I did physical labor until 10 pm and then started some school work, but found my arm almost unable to move and my mood was deteriorating. When I went to bed and lied down, it hit me. It is 4 am and it is still going strong.
19 2021-03-28 pain in extremity Sore arm lasting for three days. Lymph Node swelling left axillary region.
19 2021-03-29 numbness, inability to speak Extreme fatigue, labored breathing, hyperventilation, numb fingers and toes, inability to speak, fev... Read more
Extreme fatigue, labored breathing, hyperventilation, numb fingers and toes, inability to speak, fever, backache, body aches. Was at work at time symptoms began and workplace was going to call ambulance, but instead called parents to pick him up to take to emergency room/urgent care.
19 2021-03-29 tremor Shortly after vaccine administration, pt c/o numbness to tongue, "difficulty" to back of throat, and... Read more
Shortly after vaccine administration, pt c/o numbness to tongue, "difficulty" to back of throat, and shakiness. Dr. evaluates and finds no SOB, clear lung sounds, maintained 99-100% O2 sat on room air, and intermittent tachycardia. Benadryl and zyrtec administered, pt advised to eat as he reports he hasn't had much today. Dr. advises to go to ED if anything changes.
19 2021-03-30 depressed level of consciousness Sudden onset of fever, muscle weakness, loss of alertness
19 2021-03-30 migraine, pain in extremity Sore arm, migraine/severe headache, lightheaded, shortness of breath
19 2021-03-31 flushing Patient became light headed and slumped per the vaccinating nurse and she rushed over to escort him ... Read more
Patient became light headed and slumped per the vaccinating nurse and she rushed over to escort him to the ground. I arrived at that time as patient was being escorted to the ground.Patient was diaphoretic, red, and per patient he felt light headed. He never lost consciousness. Vitals were taken and patient was stable. B/P was 115/76, HR 65, RR 35, 99% on room air, and blood sugar was 97. Patient had no complaints of pain. Paramedics were called and patient was taken to the nearest hospital.
19 2021-04-04 feeling hot Patient complained of dizziness immediately after walking to checkout station. We sat him down and h... Read more
Patient complained of dizziness immediately after walking to checkout station. We sat him down and he said he was only seeing black and he was got and his neck hurt. We called EMS to check him out also. His BP was 140/90 and his vision started to come back after a couple of minutes as blurry. Once EMS arrived, he was much improved and vitals were all good. He refused to go to the ER, but his roommate assured us that he would watch him today. Patient waited 30 minutes and said he felt totally fine when he left.
19 2021-04-07 flushing vasovagal response. - sudden flushing - faint feeling x30 seconds - passed out while seated (x3 seco... Read more
vasovagal response. - sudden flushing - faint feeling x30 seconds - passed out while seated (x3 seconds) - resolved unconsciousness after laying prone - nausea and dry heaving once conscious x1 minute return to normal after 5 minutes (and given 500mg tylenol & 25mg benedryl)
19 2021-04-08 pain in extremity Arm still hurts, can?t get a full breath in, somewhat coughing
19 2021-04-08 restless legs syndrome, hot flush During post vaccination wait time. Patient noticeably anxious/restless/bouncing legs. Initial assess... Read more
During post vaccination wait time. Patient noticeably anxious/restless/bouncing legs. Initial assessment patient reported feeling like he had a hot flash and arms and were itchy. Vitals taken every five minutes, potential seizure activity noted, patient positioned for safety on cot. EMS activated, hives noted on left upper shoulder and left side of face. Patient complained of shortness of breath and crying. Patient became pale and LOC and temporary apnea noted, 0.3mg EpiPen administered in left leg x 1 dose, by RN. After administration patient gasped became combative. EMS arrived and patient transported via EMS to ED.
19 2021-04-10 seizure, muscle twitching "Asyncope followed by apparent seizure activity. Palor, stiffness with jerking motion of muscles to ... Read more
"Asyncope followed by apparent seizure activity. Palor, stiffness with jerking motion of muscles to extremities. Pt. lost conciousness multiple times (2 to 3). Patient was transported to hospital via EMS
19 2021-04-11 tremor, weakness The day following the vaccine at 2:30 AM, I had terrible chills, headache, shaking, and full-body we... Read more
The day following the vaccine at 2:30 AM, I had terrible chills, headache, shaking, and full-body weakness. 9:30 AM, I got out of bed and fainted soon after (reason for filing this report). The next day at 2:30 AM, every symptom went away.
19 2021-04-12 inability to speak, seizure like phenomena Seizure-like symptoms for around 3 minutes. Struggled to breath, move, talk, intense pain in chest a... Read more
Seizure-like symptoms for around 3 minutes. Struggled to breath, move, talk, intense pain in chest and head. Fever and headache for several days after.
19 2021-04-13 cold sweat, tremor This was reported to me by RN. "Pt was vaccinated, stated he felt like he was "going to pass out," ... Read more
This was reported to me by RN. "Pt was vaccinated, stated he felt like he was "going to pass out," slumped over in his chair. Was lowered to the floor in a sitting position by the vaccinator and another staff member. Pt exhibited symptoms - clammy pale skin, sweating and some shaking of body. B/P 60/30 HR 38." Transported to the hospital.
19 2021-04-13 tension headache, migraine Developed "moderna arm" (raised inflammation with itching 1.5-2 inches long and 0.5-1 inches across)... Read more
Developed "moderna arm" (raised inflammation with itching 1.5-2 inches long and 0.5-1 inches across) 7 days post vaccination from injection 1. Developed somewhat severe tension headache on day 1 post vaccination from injection 2 (all further events listed below are from injection 2). Headache responded to ibuprofen. On day 4 post vaccination, began experiencing minor and infrequent migraine-like headaches that lasted for a few seconds to a minute. Moderate pain and localized. Pain site changed but was generally on left side. Experienced 0-2 a day until day 12. On day 11 post vaccination, began experiencing full, moderate tension headache. In addition, had more frequent migraine-like headaches. Did not respond to 400mg ibuprofen or 10mg Claritin. On day 12 post vaccination, began experiencing photophobia. Mentioned to general practitioner out of an abundance of caution who recommended Excedrin. Took two Excedrin extra strength (total dosage: Acetomenaphin 500mg, Aspirin 500 mg, Caffeine 130 mg). Tension headache ended and most (but not all) migraine-like pain subsided. Some occasional pain ranging from 1-2 out of 10. On day 13 out of an abundance of caution following reports of other events I went to the ER. The doctor there examined for any cognitive symptoms (asked me to follow her finger with my eyes, squeeze fingers, checked ability to move extremities, etc) and concluded no risk of CVST. Determined that vaccine likely lowered my threshold for headaches and migraines (I have had very infrequent cluster headaches lasting for a few seconds in the past, never for this duration). Final diagnosis was migraines. Doctor prescribed Fioricet and gave me a long-acting steroid. Some pain is still there, but symptoms have mostly stopped. Waves of quick bursts of pain on localized areas on the left side of my head are still occuring.
19 2021-04-14 numbness After about 10 minutes after vaccination patient complained of difficulty breathing, excessive sweat... Read more
After about 10 minutes after vaccination patient complained of difficulty breathing, excessive sweating, numbness in hands and he was very pale. I called 911 and gave him one dose of epipen, Patient felt much better very quickly. Police and ems show up within a few minutes and stayed with him for about 45 minutes. He was fine and they cleared him. Neither he or ems felt it was necessary to transport him to the hospital. I called him later in the day and he was feeling fine.
19 2021-04-14 tingling, feeling hot, muscle twitching Muscular twitches all over the body. They will happen every so often and could be anywhere. One focu... Read more
Muscular twitches all over the body. They will happen every so often and could be anywhere. One focus site is the right leg above the knee. At times it will all of the sudden feel very hot and there will be many muscle twitches in the area. It is not pink or swollen, and does not feel hot to the touch. Also receiving the feeling of pins and needles in different places like the right leg, the shoulders and the neck.
19 2021-04-15 burning sensation rash - "burning" sensation to palms, hands, and feet
19 2021-04-15 seizure 4 seizures; anaphylaxis; This spontaneous case was reported by a physician (subsequently medically c... Read more
4 seizures; anaphylaxis; This spontaneous case was reported by a physician (subsequently medically confirmed) and describes the occurrence of SEIZURE (4 seizures) and ANAPHYLACTIC REACTION (anaphylaxis) in a 19-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 037B21A) for COVID-19 vaccination. The patient's past medical history included Seizures. Concomitant products included ACETAMINOPHEN, ATOMOXETINE HYDROCHLORIDE (STRATTERA), CLONIDINE, DIAZEPAM (VALIUM), FLUOXETINE HYDROCHLORIDE (PROZAC), LEVETIRACETAM (KEPPRA), ONDANSETRON (ZOFRAN [ONDANSETRON]), OXYCODONE and OMEPRAZOLE (PROTONIX [OMEPRAZOLE]) for an unknown indication. On 09-Apr-2021, the patient 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 first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 09-Apr-2021, the patient experienced SEIZURE (4 seizures) (seriousness criteria hospitalization and life threatening) and ANAPHYLACTIC REACTION (anaphylaxis) (seriousness criteria hospitalization and life threatening). On 09-Apr-2021, SEIZURE (4 seizures) had resolved and ANAPHYLACTIC REACTION (anaphylaxis) was resolving. For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter considered SEIZURE (4 seizures) and ANAPHYLACTIC REACTION (anaphylaxis) to be related. Hospitalization unknown meds. This is a 19 -year-old, male patient who received Moderna COVID-19 Vaccine) (batch no. 037B21A) and experienced seizures and anaphylactic reaction one day after receiving second dose of vaccine. Medical hx includes seizures Some relevant conmeds atomoxetine, clonidine, diazepam, fluoxetine, levetiracetam, and oxycodone were provided. Very limited information has been reported at this time. No further information is expected Reporter did not allow further contact; Sender's Comments: This is a 19 -year-old, male patient who received Moderna COVID-19 Vaccine) (batch no. 037B21A) and experienced seizures and anaphylactic reaction one day after receiving second dose of vaccine. Medical hx includes seizures Some relevant conmeds atomoxetine, clonidine, diazepam, fluoxetine, levetiracetam, and oxycodone were provided. Very limited information has been reported at this time. No further information is expected
19 2021-04-16 seizure Several minutes after receiving the vaccination, while waiting in the post vaccine area, patient had... Read more
Several minutes after receiving the vaccination, while waiting in the post vaccine area, patient had either a seizure or fainted. I did not witness the occurrence. 911 was called and patient was transported to the hospital.
19 2021-04-17 numbness Sick and achy for three days. Both hands randomly going numb, and everything taste sour.
19 2021-04-17 pain in extremity left arm pain beginning 3 days post vaccination; treated at home with OTC pain relievers and active ... Read more
left arm pain beginning 3 days post vaccination; treated at home with OTC pain relievers and active ROM; presented to clinic 2 days after symptom onset; scant ecchymosis noted to vaccination site; site visibly high on deltoid muscle; diagnosed with bursitis and treated with Ibuprofen prescription and rest
19 2021-04-19 weakness, numbness Patient had parked in the COVID vaccine waiting area, and was observed to fall forward onto his stee... Read more
Patient had parked in the COVID vaccine waiting area, and was observed to fall forward onto his steering wheel within a few minutes of parking by 2 other participants waiting in the car next to him. One of them immediately notified one of the parking lot volunteers who came and got me within 1 minute of this observation. 2 students and I came quickly to the open drivers side door and began talking to assess the situation. Mr. Bannister appeared pale, mildly diaphoretic (sweating) and slightly confused as to the passage of time, but was able to state and spell his name and talk coherently about his circumstances. He stated that he was not allergic to anything that he knew about, and that he had no prior history of similar reactions to vaccines or medicines although he had not taken any shots in several years. He noted that he had not eaten anything since breakfast (now mid-afternoon). He described himself as initially feeling weak, faint, and nauseated with his vaccinated arm feeling heavy and numb. He also reported that he had a sensation of blurriness before passing out, but denied any spinning sensation, visual loss or ringing in the ears. There were no obviously visible abrasions or bleeding on his face or forehead. The nursing students brought a chair, and we elevated his legs and gave him some water to drink during the time we were monitoring his vital signs. He refused a cupcake because of the nausea, but as time progressed he gained facial color and was more comfortable in conversing. His hands had equal muscle grip and strength, visible fingernail beds were pink and his capillary refill was less than 3 seconds. Towards the end of our monitoring, he did accept some nuts and M & Ms to eat. A University Safety Medical Report was completed by the appropriate safety personnel. He was fully AAO x 3 at the end of our monitoring, and stated that if he felt better he would drive to his apartment (less than 5 minutes away) but would wait for his girlfriend to get out of class if he did not feel fully capable of driving. We encouraged him to eat something light when he got home, to use cool water/warm water soaks at his shot site, exercise his arm, and to take an NSAID for pain relief the next day. We recommended that he eat something light before his second shot (which had already been scheduled), that he bring someone with him the next time, and as a precaution to wait 30 minutes following the second shot. He left at 3: 15 pm driving his car without any apparent difficulties. An online report was completed for the incident 04/20/2021.
19 2021-04-21 weakness The patient passed out 3-5 min after vaccination. He notified staff of feeling faint. He was unconsc... Read more
The patient passed out 3-5 min after vaccination. He notified staff of feeling faint. He was unconscious <1 minute. He was pale, diaphoretic and felt weak. However, he was alert and speech was clear. Within 5 minutes his palor improved and the diaphoresis and weakness began to improve. Cold ice packs were applied. No treatment given. The patient reported he "has done this before." He remained onsite for 1 hour, at which time he reported he "felt normal". Also, I spoke with him by phone at 5:30 pm and he stated " I made it home fine and I'm good".
19 2021-04-22 tingling, feeling hot Pt c/o discomfort in both calves; tingling in hands and feet; "hot feet" since receiving Moderna vac... Read more
Pt c/o discomfort in both calves; tingling in hands and feet; "hot feet" since receiving Moderna vaccine 1 week ago. Nothing abnormal noted on exam.
19 2021-04-22 seizure Patient reported having having seizure 2 hours after having the moderna covid shot. He said he woke ... Read more
Patient reported having having seizure 2 hours after having the moderna covid shot. He said he woke up and didn't know what was going on and went to the emergency room. That was all that was mentioned and it was several days later that he reported the incident.
19 2021-04-22 seizure At 0750 pt had 1st dose of covid vaccine moderna on Right Deltoid, at 0757 pt started to have seizur... Read more
At 0750 pt had 1st dose of covid vaccine moderna on Right Deltoid, at 0757 pt started to have seizure and witnesses by staff and mother lasted less than 30 seconds. Pt Woke up and alert oriented x4. (11 activated. Pt BP 138/45, HR 69, RR 17, 97. 0805 Pt BP 108/59, HR 64, RR 16, O2 at 100 % at 2lpm via nasal canula . 0810 fire deparment arrived. Pt and pt parents refused to go to ED 0820. Pt Bp 115/60, HR 66, RR 16, O2 at 100 % RA and NSR On ekg done by fire department . Pt is alert oriented x4 Fully awake. . Moderna lot # 001C21A Exp. 10/12/21. At 0830 pt went home assess by PA. Pt is asymptomatic.
19 2021-04-23 weakness, unresponsive to stimuli Systemic: Exhaustion / Lethargy-Medium, Systemic: Fainting / Unresponsive-Medium, Systemic: Weakness... Read more
Systemic: Exhaustion / Lethargy-Medium, Systemic: Fainting / Unresponsive-Medium, Systemic: Weakness-Medium, Additional Details: Patient became light headed and may have fainted. Pt stated he felt as if he had to vomit, but never did. BP and pulse taken, Normal 125/74 and pulse at 58. Pt has previous history of vasovagal response to vaccines. Total duration until patient able to walk on own 20 minutes.
19 2021-04-23 pain in extremity i had regular symptoms the day of and after my vaccine. Headaches, body ache, tired, sore arm, sligh... Read more
i had regular symptoms the day of and after my vaccine. Headaches, body ache, tired, sore arm, slight difficulty breathing, and slightly faster heart rate. Those didn't really concern me since i took it as the vaccine is working like it?s supposed to. but starting yesterday when i woke up until this moment i?ve had a really weird pinching feeling by my heart and the side of my rib cage on the left side of my chest. that?s the only thing scaring me now since my other side effects have already gone away.
19 2021-04-27 cold sweat Cold sweats, inability to sleep, fever, chills
19 2021-04-29 paralysis 4-25-21 9:45 PM - full body paralysis for 48 hours. As of 4-30-21 9:40 am can walk, can move hands.... Read more
4-25-21 9:45 PM - full body paralysis for 48 hours. As of 4-30-21 9:40 am can walk, can move hands....still issue with balance and dexterity. Approx at 90% capacity.
19 2021-04-30 seizure Systemic: Confusion-Medium, Systemic: Dizziness / Lightheadness-Severe, Systemic: Hypotension-Severe... Read more
Systemic: Confusion-Medium, Systemic: Dizziness / Lightheadness-Severe, Systemic: Hypotension-Severe, Systemic: Seizure-Severe, Additional Details: pt had a series of seizures (3+ as montiored by a np), low bp and confusion. was taken to hospital
19 2021-05-03 pain in extremity 4/29/21 3:30 PM - Vaccine Administered, right arm soreness and fatigue throughout rest of day 4/30/2... Read more
4/29/21 3:30 PM - Vaccine Administered, right arm soreness and fatigue throughout rest of day 4/30/21 12:00 PM - Woke up, fatigue, body and headaches, fever, chills, chest pain and tightness throughout day, intermittent naps 10:00 PM - Fell asleep 5/1/21 11:00 AM - Woke up, chest pain and tightness persists, other symptoms minimized 9:00 PM - Check into ER, underwent series of tests (blood work, EKG, etc.) - EKG showed serious heart problems 11:00 PM - Medevaced to second hospital 5/2/21 12:00 AM - Underwent cardiac catheterization, showed inflammation around the heart 1:00 AM - Sent to ICU bed to recuperate and heal from catheterization 9:00 AM - Given Colchicine, Ultrasound admininstered showing still lower than normal heart activity Mid-morning/mid-day - Given metoprolol 12:00 PM - Moved to regular bed, symptoms somewhat improving Rested 5/2/2021 6:30 AM - diagnosis of Myopericarditis , 9:00 AM - Given colchicine and metoprolol, symptoms reduced 11:00 AM - Discharged
19 2021-05-04 unresponsive to stimuli PT received the vaccine and slumped over on the table, was caught by a nurse and was unresponsive. P... Read more
PT received the vaccine and slumped over on the table, was caught by a nurse and was unresponsive. PT fell backward in his chair and was unresponsive. PT fell backward in his chair and was caught by paramedic on scene. PT did not hit head at any point. After being caught the PT was roused and responded to his name. Total time unresponsive was approximately 10-15 seconds. After being roused PT was placed on a stretcher using sit-pick movement technique, brought to a private location and assessed. Assessment revealed PT to be a&Ox4 GCS 15, blood pressure 116/70, pulse 84, RR 18, skin signs pale, cool, dry, pupils equal and reactive to light and motion, 6mm in diameter. During assessment PT was asked about medical history. PT stated that he had an allergy to penicillin as a child that included a rash and no anaphylactic reaction. PT stated that he had laparoscopic surgery for two hernias in approximately august of 2020. PT also stated that he has a history of syncopal episodes, usually during blood draws, but never during an injection or vaccination before. PT was reassessed approximately 5 minutes after the initial assessment. PT was A&Ox4 GCS 15, BP 122/72, PR 76, RR 16. Skin S:Warm, Dry, pink, PEARL-5mm. PT was given water, color improved and mentation remained normal/intact. PT was urged to contact a doctor for more definitive evaluation at his earliest continence. PT observed for 30+ minutes with no recurrence of symptoms, denying pain, dizziness, or any other complaint. PT reassessed prior to leaving clinic. PT was A&Ox4, GCS 15, BP 122/76. PR 64, RR 16, Skins: Pink, warm, dry, PEARL-4mm. PT left facility at 11:32am accompanied by two acquaintances who also received vaccine .
19 2021-05-05 migraine High fever >103F Headaches Migraines with eye pain Nausea Vomiting Chills Body aches
19 2021-05-06 feeling jittery Approximately 2-3 mins after the injection, patient can to the pharmacy jittery, and stating he coul... Read more
Approximately 2-3 mins after the injection, patient can to the pharmacy jittery, and stating he couldn't see and felt dizzy. Stated his pulse was felt low. Patient became pale and stated he has ringing in the ears.
19 2021-05-06 tremor Pt was waiting in 15 minute waiting area. Was doing fine then went unconscious-fainted, went to the ... Read more
Pt was waiting in 15 minute waiting area. Was doing fine then went unconscious-fainted, went to the floor slowly from the chair. Woke in about 15 seconds. Negative for head injury. Slightly nauseated, -HA, + shaking. Recovered, then -HA, -Shaking. HR was lower than his normal HR. Offered food/drink and patient was able to do this. Patient reported feeling better. Offered to call for a ride home, but patient denied, reporting that he felt "100% better".
19 2021-05-07 cold sweat Pallor, diaphoresis; cool and clammy; dizziness syncope; bradycardia; nausea and clear color emesis;... Read more
Pallor, diaphoresis; cool and clammy; dizziness syncope; bradycardia; nausea and clear color emesis; Vital signs :BP- 102/60; 118/78; 116/76 . P-60; 70;76. Resp-16-20 .O2 sats 100%. treatment provide supine position elevation of lower extremities. Cool pack to head and back of neck . Client asymptomatic upon release. Skilled instructions provide to refrain for use on influential substances , as well not to be under the influence with 2nd dose appointment. Verbal understanding noted.
19 2021-05-08 depressed level of consciousness pt was very nervous before the vaccine, he was okay right after he received shot and commented it wa... Read more
pt was very nervous before the vaccine, he was okay right after he received shot and commented it was not bad. After vaccine he was sitting in post vaccine area he got up and said feels very light head. I came out of the pharmacy to direct him back to chair while holding him , he started fainting we sat him down. Eye was rolling and unconscious his mom kept calling out to him . His color was pale. We called 911. he was conscious mom gave him gatorade he vomited right away but said he is feeling better. I kept rubbing his back. He said he was nervous all day and had not eaten .
19 2021-05-08 feeling cold Chills, High Fever, Muscle Fatigue, Headaches, Can't raise left arm
19 2021-05-15 unresponsive to stimuli 19 year old patient came to pharmacy with dad to get first dose of Moderna Vaccine. Questionnaire wa... Read more
19 year old patient came to pharmacy with dad to get first dose of Moderna Vaccine. Questionnaire was completed online with no's to all questions. Patient was sitting in booth and seemed comfortable while getting vaccine, but immediately after started to lean towards wall and faint. Patient's father and I supported patient so he didn't fall and injure himself. Patient was nonresponsive for about 5 to 10 seconds before he became responsive. He was able to sit by himself after about 1 minute of support from his dad. Patient was given water and waited 15 minutes in the booth while being monitored. He seemed to be himself after about 5 minutes. During those 15 minutes I talked to patient's dad about patient's medical history. He may had 1 seizure when he was younger due to ADHD medication but test results did not confirm it as a seizure. He also passed out one time in high school while watching biology movies with blood. Discussing this incident with the father and patient, we agreed this patient seems to have suffered from syncope due to fear of needles. I gave his father my business card and told him to call me if the patient reported any symptoms after leaving or if he had any questions whatsoever. I let them know I would be reporting this to VAERS and encouraged him to follow up with his PCP about this incident.
19 2021-05-16 feeling hot A lot of chest pains, so much they had to take pain reliever, hot and sweaty (fever), very tired, sl... Read more
A lot of chest pains, so much they had to take pain reliever, hot and sweaty (fever), very tired, slept most of the next day. Symptoms started approximately 11 1/2 hours after vaccine.
19 2021-05-16 flushing, flushing Systemic: Dizziness / Lightheadness-Severe, Systemic: Flushed / Sweating-Medium, Systemic: Nausea-Me... Read more
Systemic: Dizziness / Lightheadness-Severe, Systemic: Flushed / Sweating-Medium, Systemic: Nausea-Medium, Additional Details: PATIENT LIGHTHEADED AND PALE AFTER ABOUT 10-15 MINS AFTER VACCINE GIVEN. PATIENT WAS RESPONSIVE. PATIENT WAS GIVEN ORANGE JUICE AND AN ICE PACK UNTIL EMT ARRIVED. EMT ARRIVED AND PT BLOOD PRESSURE WAS LOW. PT TAKEN TO NEAREST ER FOR FLUIDS.
19 2021-05-17 hot flush 4/24/21 8:30 pm headache, dizziness, feverish, body aches 4/25/21 - 5/2/2021 all the time heada... Read more
4/24/21 8:30 pm headache, dizziness, feverish, body aches 4/25/21 - 5/2/2021 all the time headache, dizziness 5/3/2021 -5:30 am headache and dizziness continued, it then at 6:15 am increased to point of almost blacking out, vision changes, then returned to previous state 5/4/2021 - 5/18/2021 headache and dizziness remained constant until noon when dizziness increased accompanied by hot flash, then returned to previous state
19 2021-05-18 unresponsive to stimuli Systemic: Fainting / Unresponsive-Medium
19 2021-05-19 pain in extremity, feeling of body temperature change After having the shot, hedeveloped left arm pain and did develop some lymphadenopathy in his left ax... Read more
After having the shot, hedeveloped left arm pain and did develop some lymphadenopathy in his left axillary region. He was dealing with nausea and dizziness, and the following day, he went to work, although he was feeling a bit ill. While at work, he was found to have a fever, so he was sent home. He has been having hot and cold flashes since then. He has had a poor appetite. He has had a dry mouth and trouble sleeping. One day prior to admission, he then developed a chest pain that became constant and persisted, so he came into the emergency department on 05/19/2021 for further care. He has developed myocarditis after receiving the first of his Moderna Coronavirus Disease 19 vaccines.
19 2021-05-19 pain in extremity 5 days after Moderna Covid Vaccine, patient developed swelling, redness and tenderness over hands/wr... Read more
5 days after Moderna Covid Vaccine, patient developed swelling, redness and tenderness over hands/wrists/knees/ankles and feet.
19 2021-05-20 tingling Joints felt sore and stiff, skin felt sensitive, almost like pins and needles- particularly along my... Read more
Joints felt sore and stiff, skin felt sensitive, almost like pins and needles- particularly along my lower back.
19 2021-05-20 seizure, weakness, grand mal seizure ADVERSE OUTCOME: patient experienced tonic clonic seizure not sustained minute after injection He to... Read more
ADVERSE OUTCOME: patient experienced tonic clonic seizure not sustained minute after injection He told our staff this happens every time he has blood drawn or an injection? Dr. in office aware at time of vaccination and present and documented below. Came in for COVID-19 vaccine. 10 minutes after shot (L) deltoid. He was sitting and said to me he was feeling dizzy and immediately he had convulsion and became pale. We called 911. It lasted 1-2 minutes. Dr. came to see him, he had irregular heartbeat, feeling very tired and weak BP (L) arm 100/60 at 4:15pm. 2nd reading after 10 minutes (L) arm 112/78 p-64. He mentioned he has same reaction after injections, or blood draw. He did not want to be taken to hospital. Pt left at 5:00 with his aunt. He is visiting. When I entered the the patient was having convulsion, clonic phase, stiffening arms and legs. The consciousness came back in 1-2 minutus; he could communicate with me. He said he could breath fine. His heart rhythm was still irregular. Blood pressure was checked. He could not walk because he was too tired. 911 called. 911 cleared patient, BP and heart rate regular and stable per staff. Discharged with family member ambulating on his own, alert and oriented. Plan: must see PCP neurologist. NOT to receive second vaccine unless has complete diagnostic work up and clearance. Should have second injection vaccine in a monitored hospital setting with paramedics.
19 2021-05-22 pain in extremity 5 minutes after getting vaccinated patient stated having issues seeing "seeing black" I offered to c... Read more
5 minutes after getting vaccinated patient stated having issues seeing "seeing black" I offered to call 911 but he did not want me to. I got him candy and water. 5 minutes later he vomited - he said he felt better but I asked him to stay for continued observation. I called him this morning and he said he just had a sore arm
19 2021-05-23 pain in extremity On 5/21/21, patient and his mom wanted to get Moderna 2nd dose before he headed back to school up no... Read more
On 5/21/21, patient and his mom wanted to get Moderna 2nd dose before he headed back to school up north. They were adamant that the vaccine is due. Both technician and I did not see the date on vaccine card when patient was previously received at . I administered second dose for him after asking him about the first dose, and counseled him on adverse effects. When we processed the prescription later in the afternoon, insurance rejected prescription and stated earlier than 24 days. I found patient had received the dose on 5/4/21. Patient and did not answer the phone, and patient called back confirming the date of first dose given on 5/4/21. Patient did not feel anything except a sore arm, and did not have PCP.
19 2021-05-23 tingling The patient received his vaccine and 5 minutes later complained of feeling dizzy. He was instructed ... Read more
The patient received his vaccine and 5 minutes later complained of feeling dizzy. He was instructed to sit and before we could help him into a chair he lost consciousness and fell. His fall was somewhat controlled by the technician. I then assessed the patient and determined he had a vasovagal episode and lifted his legs, he returned to consciousness within 10 seconds of raising his legs. I then allowed the patient to lie on the floor for approximately 20 minutes after which he felt better and returned to sitting . He then sat for about 15 more minutes until a family member was able to arrive. The patient reported no other adverse effects other than dizziness, lightheadedness, some trouble hearing and tingling fingers.
19 2021-05-24 seizure Found deceased in bed, no known symptoms, undetermined cause and manner of death
19 2021-05-26 seizure Patient passed out within 45 seconds of vaccine, convulsed for 5 secs while unconscious. woke up wit... Read more
Patient passed out within 45 seconds of vaccine, convulsed for 5 secs while unconscious. woke up with in a minute, vomited after 3 minutes. He was able to say his name and address. BP 116/69 Pulse 68. patient said that this has happened before after an unknown booster at age 17. Only ate french fries earlier today. Was able to stand after 5 minutes. Put cool paper towel on neck, ate fruit bar and drank water before leaving
19 2021-05-28 unresponsive to stimuli Systemic: Dizziness / Lightheadness-Mild, Systemic: Fainting / Unresponsive-Medium
19 2021-05-29 numbness Patient stated that he felt itching and numbness all over a few minutes after receiving the Moderna ... Read more
Patient stated that he felt itching and numbness all over a few minutes after receiving the Moderna vaccination. He was offered dihpenhydramine but refused because he stated that he had to leave to go to work. He said that he was stopping by his house before work so he would take diphenhydramine if he needed to at home. I told the patient he should wait at the pharmacy longer for observation but he still left because he had to go work. He said that he felt okay before leaving the pharmacy.
19 2021-06-01 weakness Patient started having generalized body weakness and fatigue few hours after vaccination on 05/22/2... Read more
Patient started having generalized body weakness and fatigue few hours after vaccination on 05/22/2021. He subsequently developed chest pain on 05/23/2021 which progressively worsened and resulted in his presentation at the emergency room on 05/25/2021. While in the ED, Troponin was elevated at 17.22. EKG done had revealed ST elevations with PR depression. Cardiac MRI done showed myocardial edema involving the mid/apical lateral wall suggestive of acute myocarditis/inflammation. Patient received a loading dose of Colchicine and Ibuprofen as anti-inflammatory agents. Troponin was trended and peaked at 23.60 and slowly down-trended to 1.84 on 5/28/21 and he was subsequently discharged to follow up as outpatient.
19 2021-06-01 pain in extremity, tremor Patient received Moderna Covid-19 vaccination at 10:50 AM on June 2, 2021. Within 10 minutes patient... Read more
Patient received Moderna Covid-19 vaccination at 10:50 AM on June 2, 2021. Within 10 minutes patient describes being shaky. Patient was given orange juice. After 2-3 minutes patient described chest tightness which progressed into left arm pain during our conversation and was not improving. 911 was called. As paramedics arrived, approximately 11:30-11:40 AM, patient began to complain of trouble swallowing but no trouble breathing. Paramedic checked patients heart and patient started to develop hives. The paramedic gave the patient diphenhydramine and then was taken to the hospital for treatment.
19 2021-06-01 seizure, weakness Dizziness/ dizzy; Weakness/ very weak; Seizures; Fainted; This spontaneous case was reported by a co... Read more
Dizziness/ dizzy; Weakness/ very weak; Seizures; Fainted; This spontaneous case was reported by a consumer (subsequently medically confirmed) and describes the occurrence of SEIZURE (Seizures), SYNCOPE (Fainted), DIZZINESS (Dizziness/ dizzy) and ASTHENIA (Weakness/ very weak) in a 19-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. No Medical History information was reported. On 07-May-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 07-May-2021, the patient experienced SEIZURE (Seizures) (seriousness criteria hospitalization and medically significant) and SYNCOPE (Fainted) (seriousness criteria hospitalization and medically significant). On 16-May-2021, the patient experienced DIZZINESS (Dizziness/ dizzy) (seriousness criterion hospitalization) and ASTHENIA (Weakness/ very weak) (seriousness criterion hospitalization). The patient was hospitalized on 07-May-2021 due to SEIZURE and SYNCOPE, then on 16-May-2021 due to ASTHENIA and DIZZINESS. The patient was treated with PARACETAMOL (TYLENOL) at an unspecified dose and frequency. At the time of the report, SEIZURE (Seizures) and SYNCOPE (Fainted) outcome was unknown and DIZZINESS (Dizziness/ dizzy) and ASTHENIA (Weakness/ very weak) had not resolved. The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown. No concomitant medications were reported. Description: During the day of the injection, at 5 to 10 minutes, the patient fainted and had seizures that required hospitalization. Also, on 16 May 2021 the patient required hospitalization again because of the dizziness and weakness. The patient was still dizzy and was very weak. The patient had a consult with a neurologist and who told that the symptoms were probably becasue of the vaccine. Other treatment information included unspecified pill for dizziness at the hospital. Company comment: Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded.; Sender's Comments: Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded.
19 2021-06-01 unresponsive to stimuli, flushing Systemic: Chills-Mild, Systemic: Confusion-Severe, Systemic: Dizziness / Lightheadness-Medium, Syste... Read more
Systemic: Chills-Mild, Systemic: Confusion-Severe, Systemic: Dizziness / Lightheadness-Medium, Systemic: Fainting / Unresponsive-Severe, Systemic: Flushed / Sweating-Mild, Systemic: Hypotension-Medium
19 2021-06-02 weakness, pain in extremity left arm pain/ afebrile/ dizzy/ weak
19 2021-06-06 tremor Patient felt lightheaded and shaky.
19 2021-06-14 discomfort Patient received vaccine series at a separate facility. I do not have access to this information. He... Read more
Patient received vaccine series at a separate facility. I do not have access to this information. He reported receiving Moderna dose #2 on Tuesday, June 8. Within hours, he began to have chest pain, shortness of breath, general body aches and fatigue. Chest pain was worse with deep breath and worse with supine position. On Friday, June 11, he presented to The Clinic at with these complaints. He was noted to be in evident severe discomfort, though not in respiratory distress. Vitals as follows: pulse 82 and regular, BP 139/68, respiratory rate 20, temperature 99.2 oral, SaO2 98% on room air. Exam was notable for absence of a pericardial friction rub. Lungs were clear to auscultation. he had no rashes and no remarkable tenderness of the body to palpation. Extremities were without edema. There was no sign of clinical heart failure or cardiovascular insufficiency.
19 2021-06-15 facial paralysis, bell's palsy Within 24 hours severe headache, followed by inner war pain, then on Morning of 6/13/2021 awoke with... Read more
Within 24 hours severe headache, followed by inner war pain, then on Morning of 6/13/2021 awoke with left sided facial paralysis inability to close eye or lift smile.
19 2021-06-15 migraine Projectile vomiting High fever Migraine Chills Severely swollen limb on side of injection Dizziness
19 2021-06-29 pain in extremity, tingling nose was congested; throat was scratchy; really bad headache; feeling a lot of fatigue/feeling more ... Read more
nose was congested; throat was scratchy; really bad headache; feeling a lot of fatigue/feeling more tired than he usually is; severe allergic reaction/allergic reaction to the vaccine; fingers tingling; tongue felt abnormally large; bumps on his face, back, chest and stomach; pattient felt very uncomfortable; Sore arm; This spontaneous case was reported by a consumer and describes the occurrence of HYPERSENSITIVITY (severe allergic reaction/allergic reaction to the vaccine) in a 19-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below. No Medical History information was reported. On 05-Jun-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 05-Jun-2021, the patient experienced HYPERSENSITIVITY (severe allergic reaction/allergic reaction to the vaccine) (seriousness criteria medically significant and life threatening), PARAESTHESIA (fingers tingling), PARAESTHESIA ORAL (tongue felt abnormally large), URTICARIA (bumps on his face, back, chest and stomach), FEELING ABNORMAL (pattient felt very uncomfortable) and PAIN IN EXTREMITY (Sore arm). On 18-Jun-2021, the patient experienced NASAL CONGESTION (nose was congested), OROPHARYNGEAL DISCOMFORT (throat was scratchy), HEADACHE (really bad headache) and FATIGUE (feeling a lot of fatigue/feeling more tired than he usually is). The patient was treated with DIPHENHYDRAMINE HYDROCHLORIDE (BENADRYL [DIPHENHYDRAMINE HYDROCHLORIDE]) for Allergic reaction, at a dose of 1 dosage form; EPINEPHRINE (EPIPEN) for Allergic reaction, at a dose of 1 dosage form and ASPIRIN [ACETYLSALICYLIC ACID] for Adverse event, at a dose of 1 dosage form. On 05-Jun-2021, HYPERSENSITIVITY (severe allergic reaction/allergic reaction to the vaccine), PARAESTHESIA (fingers tingling), PARAESTHESIA ORAL (tongue felt abnormally large), URTICARIA (bumps on his face, back, chest and stomach) and FEELING ABNORMAL (pattient felt very uncomfortable) had resolved. On 07-Jun-2021, PAIN IN EXTREMITY (Sore arm) had resolved. At the time of the report, NASAL CONGESTION (nose was congested), OROPHARYNGEAL DISCOMFORT (throat was scratchy), HEADACHE (really bad headache) and FATIGUE (feeling a lot of fatigue/feeling more tired than he usually is) outcome was unknown. The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown. Concomitant product use is not provided by the reporter. Reportedly, patient stayed at hospital for one hour until treatment made effect. The patient is thinking whether to take a second dose of moderna or not. Company Comment: Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded.; Sender's Comments: Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded.
19 2021-06-29 seizure, tremor Anxiety is really bad; severe allergic reaction; seizure like activity; significant amount of shakin... Read more
Anxiety is really bad; severe allergic reaction; seizure like activity; significant amount of shaking and diaphoresis; significant amount of shaking and diaphoresis; afraid to receive the second shot; This spontaneous case was reported by a nurse and describes the occurrence of ALLERGY TO VACCINE (severe allergic reaction), SEIZURE (seizure like activity), TREMOR (significant amount of shaking and diaphoresis), HYPERHIDROSIS (significant amount of shaking and diaphoresis) and ANXIETY (Anxiety is really bad) in a 19-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below. No Medical History information was reported. In April 2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. In April 2021, the patient experienced ALLERGY TO VACCINE (severe allergic reaction) (seriousness criteria hospitalization and life threatening), SEIZURE (seizure like activity) (seriousness criteria hospitalization, medically significant and life threatening), TREMOR (significant amount of shaking and diaphoresis) (seriousness criterion hospitalization) and HYPERHIDROSIS (significant amount of shaking and diaphoresis) (seriousness criterion hospitalization). On an unknown date, the patient experienced ANXIETY (Anxiety is really bad) (seriousness criterion hospitalization) and INTENTIONAL PRODUCT USE ISSUE (afraid to receive the second shot). The patient was hospitalized on sometime in April 2021 due to ALLERGY TO VACCINE, HYPERHIDROSIS, SEIZURE and TREMOR. The patient was treated with EPINEPHRINE (EPIPEN) in April 2021 for Allergy to vaccine, at a dose of 1 dosage form, unknown. At the time of the report, ALLERGY TO VACCINE (severe allergic reaction), SEIZURE (seizure like activity), TREMOR (significant amount of shaking and diaphoresis), HYPERHIDROSIS (significant amount of shaking and diaphoresis) and ANXIETY (Anxiety is really bad) outcome was unknown and INTENTIONAL PRODUCT USE ISSUE (afraid to receive the second shot) had resolved. DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): In April 2021, Blood pressure measurement: went way up (High) went way up. In April 2021, Heart rate: went way up (High) went way up. The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown. For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments. Concomitant medications were not provided by the reporter. The patient received his first Moderna vaccine dose on maybe 02-Apr-2021 or 03-Apr-2021, possibly in his right arm. Within 5-10 minutes, he had a severe allergic reaction which consisted of seizure-like activities. The patient was treated with an EpiPen shot and sent to the emergency room. It was reported the patient had anxiety which was really bad and he was now being treated with an unspecified anti-anxiety medication to help. Company comment: Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded.; Sender's Comments: Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded.
19 2021-07-02 unresponsive to stimuli Systemic: Fainting / Unresponsive-Mild, Additional Details: patient fainted immediately after receiv... Read more
Systemic: Fainting / Unresponsive-Mild, Additional Details: patient fainted immediately after receiving vaccine, seemed slightly disoriented initially upon waking up, felt nauseous, but symptoms rapidly improved after drinking water and eating crackers and remaining seated. Patient called mom to pick him up so that he was not at risk driving home alone.
19 2021-07-06 tingling pt stated his hand was swollen and started feeling tingly
19 2021-07-11 tremor Within 1 minute of receiving vaccination, patient became lightheaded and passed out. Patient regaine... Read more
Within 1 minute of receiving vaccination, patient became lightheaded and passed out. Patient regained consciousness within 1 minute of passing out. Upon regaining consciousness patient reported a headache, dizziness, shakiness, and nausea. The patient appeared pale. The patient was given water and peanut butter crackers. After 30 minutes patient returned to normal and was able to leave the pharmacy on his own.
19 2021-07-13 involuntary muscle movements Patient had jerking motions, passed out and fell on the floor. sweating, discoloration of face. 911... Read more
Patient had jerking motions, passed out and fell on the floor. sweating, discoloration of face. 911 was called, and pt was taken by ambulance to hospital
19 2021-07-14 feeling hot Felt very hot and sweaty about 10 minutes after immunization. Was better within the next 30 minutes.
19 2021-07-17 tingling, feeling of body temperature change On 7/16/21 patient received second dose of Covid-19 at approximately 10:00 AM. At around 5:00 PM p... Read more
On 7/16/21 patient received second dose of Covid-19 at approximately 10:00 AM. At around 5:00 PM patient starting feeling hot and cold which slowly progressed to where he felt like he had the normal flu around 8:00 PM. About 15 minutes later he experienced slight tingling in hands, progressed to almost full body tingling sensation, most powerful in hands and feet. It was at its most powerful around 10:00 PM and he considered going to the hospital but did not. The tingling sensation subsided around midnight 12:00 AM. When he woke up on 7/17/21 he felt better and has been feeling better ever since. None of the symptoms have returned as of 7/18/21. Patient will follow up with his doctor.
19 2021-07-18 pain in extremity Pt is a 19-year-old male with past medical history of hyperlipidemia, obesity who presents this hosp... Read more
Pt is a 19-year-old male with past medical history of hyperlipidemia, obesity who presents this hospital on 7/19/21 for chest pain and shortness of breath following administration of COVID-19 vaccination Moderna X 4 days. Patient noted to persistent substernal chest pain radiating to left upper extremity present upon exam at its worst 3/10 relieved with Advil and aspirin for which patient was taking daily following a COVID-19 vaccination Moderna first dose 7/15/2021. Patient stated pain persisted despite taking over-the-counter analgesics and had difficulty breathing today thus transported himself to the emergency department for further evaluation. Patient d admitted to subjective chills without recorded temperature, myalgias without rash, difficulty swallowing, palpitations, orthopnea, PND, increased weight gain, abdominal pain, nausea vomiting or diarrhea. Patient prior allergic reactions. Patient denied history of MI, TIA, CVA, thromboembolic events. Significant family history of mother MI and Graves' disease.
19 2021-07-28 numbness A few minutes after patient received the Moderna vaccine in his left shoulder, he reported that his ... Read more
A few minutes after patient received the Moderna vaccine in his left shoulder, he reported that his left arm was numb down through his 'pinky' finger (although he was able to move it). He subsequently reported that he felt tired, he developed a headache, he had some stomach cramps and began to get nauseous. He did not ever vomit during this period. His blood pressure was monitored and found to be elevated initially at 173/121 (with a pulse of 69). His blood pressure was monitored over the course of just over an hour. It varied over this period but was elevated. The pharmacist in charge determined that patient was not able to go back to work. Patent stated that his girlfriend with whom he lives was off work today and could stay with him. He was advised to call 911 if he started feeling worse. Patient was driven to his home by a co-worker. Through the course of the day, contact was made with Patient and his girlfriend (per his authorization). He ate and then slept for some time. Upon awakening, he vomited for awhile - but "not alot". The numbness in his arm started subsiding. The headache maintained. They had no way to check his blood pressure. At 3:36pm he indicated he was "doing somewhat better" but the nausea was not any better.
19 2021-07-28 unresponsive to stimuli Patient became dizzy after receiving vaccine and started to become unresponsive. Patient was helped ... Read more
Patient became dizzy after receiving vaccine and started to become unresponsive. Patient was helped to ground and the legs were elevated, within 10 seconds patient was responding to verbal ques and was back to 100% within 30 seconds. Patient was observed in a chair and given some water and saltine crackers for an additional 20 minutes. Patient stated he was ready to go at the end of the 20 minute wait period and left the pharmacy
20 2021-01-01 pain in extremity, cold sweat Intense arm discomfort/pain and injection site soreness, began around 2 to 3 hours after innoculatio... Read more
Intense arm discomfort/pain and injection site soreness, began around 2 to 3 hours after innoculation, lasted around 36 hours. Severe uncomfortable incessant shivering began at 21:00 12/30 and persisted for an hour. Intense cold sweats began at 20:30 12/30 and lasted around 18 hours, this symptom was also accompanied by a fever with a peak of 101.7° that lasted a similar duration. Unpleasant yet bearable body aches manifested the morning of 12/31 around 08:00 and did not subside until the next day. Throbbing, sharp headache began 12/30 at 13:00 and persisted until 12/31 around 19:00. 325mg of enteric coated aspirin was taken on three different occasions, 12/30 at 21:30, 12/31 at 08:30, and 1/1 at 00:30. 1,000mg of acetaminophen was also ingested on 1/1 at 00:30. All symptoms dispersed by noon of 1/1 and have not reoccurred.
20 2021-01-04 pain in extremity sore arm with rash/redness at injection site
20 2021-01-10 flushing, tremor Patient presented sweating, flushed, and shaking an hour after administration. Appeared to be in a p... Read more
Patient presented sweating, flushed, and shaking an hour after administration. Appeared to be in a panic attack
20 2021-01-16 pain in extremity, hypersensitivity of all senses Low grade fever and moderate chills approx. 12 hours after first dose. Headache the subsequent morni... Read more
Low grade fever and moderate chills approx. 12 hours after first dose. Headache the subsequent morning, with side effects gone after that following day, including slight arm pain. Six days later, developed sensitivity to the touch at the vaccine site, which went away after a day.
20 2021-01-17 pain in extremity Patient received vaccine on 1/13/21; started having headaches on 1/13/21 in the evening. On 1/14/21 ... Read more
Patient received vaccine on 1/13/21; started having headaches on 1/13/21 in the evening. On 1/14/21 developed chills, body aches and nausea. On 1/15/21 had chills, body aches, nausea and fevers as high as 102.0F - also developed lump in left neck on 1/15. Starting on 1/16/21 he noted pain radiating from left deltoid to left hand digits - specifically the 4th digit, palmar surface. Symptoms began improving on 1/17/21 and on that day he mainly felt just soreness in his left arm. On 1/18/21 he noticed the lump in the left neck was still present and he had tightness in the left triceps region.
20 2021-01-17 pain in extremity Moderna COVID-19 Vaccine EAU. About 6 days after the injection my arm is still slightly sore, not un... Read more
Moderna COVID-19 Vaccine EAU. About 6 days after the injection my arm is still slightly sore, not uncomfortable but it has also gotten red around the injection site, almost rash like pattern.
20 2021-01-24 tingling Complained of mild tingling in tongue, hands and chest 20 minutes following administration
20 2021-01-26 discomfort, pain in extremity 2nd dose received at 11am. Mild arm soreness immediately after. Remained for 2 days with no increa... Read more
2nd dose received at 11am. Mild arm soreness immediately after. Remained for 2 days with no increase in severity then dissipated. Lymphnode discomfort mild beginning 2 hours after vaccination. Remainder for 2 days with increase to medium severity approximately 8 hours after receiving vaccination. Nuchal rigidity began 8 hours after receiving 2nd dose, mild -> medium severity. Dissipated 1 day after receiving shot. Mild photosensitivity to light began approx 9 hours after receiving shot. Dissipated by next morning. 9 hours after receiving vaccination, medium fever developed. Baseline temperature is 96.4. At 9 hours after vaccination, developed fever at 99.7*F. At 11 hours after, temperature was 100.9*F, with severe discomfort and body aches / chills. Dissipated by following morning. Hope this helps. Thank you.
20 2021-01-31 pain in extremity, tingling, discomfort, numbness Patient developed mid to low back pain, followed by shooting pains down his legs that were 8/10 leve... Read more
Patient developed mid to low back pain, followed by shooting pains down his legs that were 8/10 level of discomfort. generalized faitgue, low grade temp. But the shooting pain down the legs persisted for 3 days. This was accompanied by some numbness and tingling of the legs. Felt unsteady on his feet. Back pain resolved within 12 hours but the shooting pains persisted. Ibuprofen did help
20 2021-02-09 migraine Fever, chills, nausea, altered sense of taste, migraine, dizziness, nasal congestion, swelling and m... Read more
Fever, chills, nausea, altered sense of taste, migraine, dizziness, nasal congestion, swelling and muscle soreness at administration site Lasted for about 12 hours, only nausea continued for 24 hours Ibuprofen and Naproxen Sodium (NSAIDs) were used from home and provided sufficient treatment of symptoms
20 2021-02-14 pain in extremity Myocarditis; Acute onset of chest pain; Soreness of the arm; A spontaneous report was received from ... Read more
Myocarditis; Acute onset of chest pain; Soreness of the arm; A spontaneous report was received from a physician concerning a 20-year-old, male patient, who received Moderna's COVID-19 vaccine (mRNA-1273) and experienced soreness of the arm, acute onset of chest pain, and myocarditis. The patient's medical history, as provided by the reporter, included asthma, and allergy to egg, peanut and tree nuts. Concomitant medications reported included dupilumab, montelukast, budesonide / formoterol, cetirizine, albuterol and epinephrine. On 29 Dec 2020, the patient received their first of two planned doses of mRNA-1273 (Lot number: 025J20A) intramuscularly for prophylaxis of COVID-19 infection. On 26 Jan 2021, prior to the onset of events, the patient received their second of two planned doses of mRNA-1273 (Lot number: 028L20A) intramuscularly in the left deltoid for prophylaxis of COVID-19 infection. On 26 Jan 2021, after receiving the second dose of the vaccine, the patient reported soreness of the arm for 3 to 4 days. On 30 Jan 2021, the patient presented to the hospital with acute onset of left sided chest pain. The physician reported that the patient developed myocarditis. Consent for Safety to follow up was received. Treatment for the events, as reported, included patient's concomitant medications of dupilumab, montelukast, budesonide / formoterol, cetirizine and albuterol. No additional treatment information was provided. Action taken with mRNA-1273 in response to the events was not reported. The event, soreness of the arm, was resolved on unknown date. The event acute onset of chest pain and myocarditis was not resolved at the time of this report.; Reporter's Comments: This case concerns a 20 year old male with medical history of multiple allergies, who was hospitalized with serious unexpected events of chest pain and myocarditis and a non-serious unexpected event of pain in extremity. The chest pain and myocarditis occurred 33 days after first dose and 4 days after last dose of mRNA-1273. Based on the current available information and temporal association between the use of mRNA-1273 and the start date of the events, a causal relationship cannot be excluded.
20 2021-02-17 migraine Migraine
20 2021-02-22 weakness, tremor, mild one side paralysis About 3d after shot, patient was at gym and noticed L arm had decreased strength and decreased grip ... Read more
About 3d after shot, patient was at gym and noticed L arm had decreased strength and decreased grip strength. No improvement since. Now has noticed some intermittent L hand tremors and L leg weakness. This was all disclosed when patient returned for shot #2. Shot #2 not given. Patient advised to discuss with PCP first.
20 2021-02-22 weakness Started with a fever that slowly worsened to a high temperature. This resulted in chills, aches, pai... Read more
Started with a fever that slowly worsened to a high temperature. This resulted in chills, aches, pains, fatigue. nausea, congestion, sore throat, headaches, and weakness. There was also swelling at the injection site and swelling of my eyelids.
20 2021-02-26 discomfort Patient appeared pale and not well, and stated "I feel sick, dizzy and like I am going to throw up".... Read more
Patient appeared pale and not well, and stated "I feel sick, dizzy and like I am going to throw up". Patient accepted PRN medication for his discomfort, 4oz of Gatorade, and 8oz of water.
20 2021-03-03 pain in extremity For the first two days a had pain in my left arm but it went away. Around 2pm on that following Sund... Read more
For the first two days a had pain in my left arm but it went away. Around 2pm on that following Sunday (4 days after) I suddenly come down with a fever and headache. I felt so tired, but I took Tylenol and I felt better through the following day. Now, on Tuesday almost a whole week after my shot I get this itching on my chest and arms. Turned out that I got hives, I am not aware of any allergies and I have only broken out into hives one other time in my life and it was 8 years ago and I still do not know the cause. It is now Thursday and the hives have somewhat gone down but I still feel the itchiness around my body. Also to note that the itches are almost about my waist (arms, chest, stomach, back, and neck) I also used the itching cream to relive the itching but I am so tired of the feeling on my body.
20 2021-03-04 pain in extremity whole body aches and pain in left arm, low grade fever of 99.8, and vomiting.
20 2021-03-04 pain in extremity The above patient received a COVID-19 vaccine on 03MAR21 @ 1440. He came to the EH&S office on the ... Read more
The above patient received a COVID-19 vaccine on 03MAR21 @ 1440. He came to the EH&S office on the morning of 04MAR21 complaining of left arm pain, fatigue, headache, muscle pain, joint pain, chills, and nausea/vomiting. He was evaluated by a healthcare provider who noted mild swelling and a small knot was felt in his left arm. He is to follow-up with our onsite nurse or his medical provider if his condition worsens.
20 2021-03-17 feeling hot Client felt dizzy and light headed. Client describes a warm sensation and reports feeling better af... Read more
Client felt dizzy and light headed. Client describes a warm sensation and reports feeling better after a few minutes. Sp02 99%, BP 108/68
20 2021-03-22 numbness Patient complained of left hand numbness around 15 minutes after receiving injection. Patient is ale... Read more
Patient complained of left hand numbness around 15 minutes after receiving injection. Patient is alert, responsive, only other complaint is palpitations. Denies ShOB, chest pain, throat tightness. Both the numbness and palpitations are not new, have been happening intermittently and is being evaluated for these symptoms. HRRR no murmurs, CTAB no wheeze, MMM, BP 142/98 with pulse of 64. Numbness mostly resolved after a few minutes. Extended observation time by 15 minutes past original time. No further issues.
20 2021-03-22 seizure Patient had vaccination and placed in observation area. Patient had syncopal episode post vaccinatio... Read more
Patient had vaccination and placed in observation area. Patient had syncopal episode post vaccination. Was seen fall down and hit head and had seizure activity that lasted less than 10 seconds. Patient had brief postictal phase without loss of bladder or bowel control. After a few seconds patient was able to relay his name and was alert and oriented to time and place. Evaluated patient for bodily harm, after finding none moved patient to medical area. Took vital signs and called for transportation to hospital. Medical transport came and after evaluation asked to take patient to hospital patient refused transportation. Patient refused going to hospital and left AMA. Of note, Patient has a history of syncope post injection that was failed to inform us. He mentioned he was afraid to needles like most patients report. Patient said it has happened before after flu shot along with syncope and seizures.
20 2021-03-24 numbness, face paralysis patient reported a few hours after vaccine left side of face feels numb and some weakness around lef... Read more
patient reported a few hours after vaccine left side of face feels numb and some weakness around left side of mouth
20 2021-03-25 involuntary muscle movements, inability to speak, unresponsive to stimuli Approximately 10 minutes after receiving the Moderna vaccine, this writer was called to the patient ... Read more
Approximately 10 minutes after receiving the Moderna vaccine, this writer was called to the patient room by other staff. The patient was extremely confused and not speaking to anyone. He was gazing to the left and not making eye contact with this writer, who was loudly talking to the patient. Multiple attempts were made to get the patient's attention with no success. The patient then began to involuntarily raise his bent left arm in front of his face and then back down to his side. In this writer's opinion, the patient was having a silent seizure. This writer sat with the patient, who became aware approximately 15 seconds later. He was able to answer questions and was quickly reoriented. At this point this writer had the staff call 911 for further evaluation. After answering basic questions appropriately., this writer gathered vital signs on the patient . The first set of vitals were: bp 88/48, pulse 60, respirations 14/min, oxygen saturation 93% on room air, temp 98.5. After small conversation with the patient, another set of vitals were taken: bp 94/70, pulse 68, respirations 15/min, oxygen saturation 95% on room air, temp 98.8. We then had the patient drink some water, then had him lie down in the patient room until EMS arrived. By the time they arrived, the patient was completed reoriented and laughing with office staff. EMS evaluated the patient and deemed him safe to go home with his friend driving. This writer walked the patient to the car to assess balance and coordination. This writer informed the patient and his friend to call 911 if symptoms returned. The patient agreed.
20 2021-03-26 unresponsive to stimuli Systemic: Fainting / Unresponsive-Mild
20 2021-03-27 pain in extremity Soreness in arm lasting two days
20 2021-03-29 unresponsive to stimuli, tremor Patient reports routinely having spells of syncope with injections and still insisted on receiving C... Read more
Patient reports routinely having spells of syncope with injections and still insisted on receiving COVID-19 vaccination. Gave injection into left deltoid. Had patient scoot up to table in immunization room with both legs fully under the table just in case there was an issue. I set the timer for 15 minutes and left him in the immunization room with his girlfriend, who also received a vaccine. A few moments later the girlfriend asked for our help stating he was feeling like he was going to pass out. I went into the IMZ room and checked with him. At the time, he was sweaty with a rapid hearbeat. I instructed him to take some deep breaths and went to get a cold paper towel to apply to his head. When I returned he had passed out, not responsive but still breathing, in his chair and his girlfriend was holding his head in her hand. We gently lowered his head to rest on the table while another associate called 911 per girlfriend's request. He began moaning a few moments later and was able to talk to us. He was very hot and sweaty, light headed and breathing rapidly. We applied a cooling pack to his forhead as he continued to lie his head on the table. He then said he might feel more comfortable lying on the floor. We assisted him to the floor, elevated his feet on a chair and placed his head on a roll of paper towels. At that time the paramedics showed up and said his blood pressure was fine and he was just having some hyperventilation. The paramedics got him back up in the chair and his girlfriend got him some apply juice. After about 30 minutes he was talking fine, shaking had stopped and his breathing a temp went back to normal
20 2021-04-01 feeling hot Pt. states that he became hot and dizzy while experiencing tunnel vision. A friend with the pt. stat... Read more
Pt. states that he became hot and dizzy while experiencing tunnel vision. A friend with the pt. stated that he fell out of the chair he was sitting in but did not hit his head on the floor. EMS and an on-scene Dr. made immediate pt. contact. It was determined that the pt. experienced a syncopal episode. He was already regaining consciousness upon arriving at his side. Vitals were taken and pt. recovered over time. Pt. signed an AMA and was taken home by a friend.
20 2021-04-01 tremor Vomiting, body shaking, chills, legs shaking.
20 2021-04-02 feeling hot, flushing Systemic: Dizziness / Lightheadness-Mild, Systemic: Flushed / Sweating-Mild, Additional Details: app... Read more
Systemic: Dizziness / Lightheadness-Mild, Systemic: Flushed / Sweating-Mild, Additional Details: approx 2-3 mins post vaccine states feeling hot, sweaty, and anxious. States previously fainted after injection. 1458 Assisted to lie on carpet in vaccination area. legs elevated on chair. States feeling better now. 1510 BP 117/74, P 93. Lungs clear to auscultation. Heart rate reg. No edema, pain or redness at vaccination site. enc to drink water. 1515 Assisted to sit in chair x 10 mins. 1526 Amb. in store. 1535 States he will leave to go home now. Home in stable condition.
20 2021-04-02 numbness Numbness in arms and hands, headache, high heart rate, slight fever, red welts on chest and back.
20 2021-04-03 migraine Fever, chills, stomach pain, nausea, vomiting, tiredness, muscle aches/pain, migraine. Lasted about ... Read more
Fever, chills, stomach pain, nausea, vomiting, tiredness, muscle aches/pain, migraine. Lasted about two days
20 2021-04-04 feeling hot Swelling, hotness, redness of injection site. In a triangle almost, put Bendaryl gel on it overnight... Read more
Swelling, hotness, redness of injection site. In a triangle almost, put Bendaryl gel on it overnight and nothing changed.
20 2021-04-05 feeling hot about 5 minutes after vaccine pt asked for a bandaid due to some heavy bleeding at injection site. ... Read more
about 5 minutes after vaccine pt asked for a bandaid due to some heavy bleeding at injection site. He then asked for water. When I brought the water to him he was very pale and said he felt like fainting. We had him lay down and elevate feet which helped him feel better but was still hot so I applied a cold ice pack on head to help him feel less hot. After about 10-15 minutes he felt better and stayed with us for about 45 mintues until he felt well enough to drive home. I checked on him about 2 hours later and he was feeling much better.
20 2021-04-07 tingling Client complained of lightheadedness and nausea. He then complained of tingling all over his body. C... Read more
Client complained of lightheadedness and nausea. He then complained of tingling all over his body. Client reported that he did not eat breakfast or lunch.
20 2021-04-12 pain in extremity, migraine 102 fever, migraine, sore arm, body aches
20 2021-04-12 tingling Pt received COVID-19 vaccine @ 1422 and reported feeling lightheaded, dizzy and tingling at approxim... Read more
Pt received COVID-19 vaccine @ 1422 and reported feeling lightheaded, dizzy and tingling at approximately 1430 in 15 minute waiting parking lot B/P 80/40 HR 66 O2 stats 97% appeared pale -encouraged to lie his seat back and rest for a few minutes. B/P received approx. 20 later and was high to 112/62 lying and 118/64 sitting --Major assessed pt and encouraged him to seek medical attention --encouraged him not to drive himself-- pt called friends to come pick him up -- he seems to have had a near episode encouraged to have had 2nd dose at a medical clinic or hospital -- monitored for approx. 5 minutes (1430-1518./m,n1
20 2021-04-15 migraine severe migraine
20 2021-04-15 pain in extremity, night sweats Partially lost smell; Partially lost taste; Headache; Short time "everything come black"/ short time... Read more
Partially lost smell; Partially lost taste; Headache; Short time "everything come black"/ short time "black down"; Sore arm; Night time sweat; Short time "lost control of muscle of neck"; Dizziness; This spontaneous case was reported by a consumer and describes the occurrence of LOSS OF CONSCIOUSNESS (Short time "everything come black"/ short time "black down") in a 20-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 037B21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below. The patient's past medical history included No adverse event (No reported medical history). On 10-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 10-Apr-2021, the patient experienced LOSS OF CONSCIOUSNESS (Short time "everything come black"/ short time "black down") (seriousness criterion medically significant), PAIN IN EXTREMITY (Sore arm), NIGHT SWEATS (Night time sweat), MUSCLE DISCOMFORT (Short time "lost control of muscle of neck"), DIZZINESS (Dizziness) and HEADACHE (Headache). On 11-Apr-2021, the patient experienced HYPOSMIA (Partially lost smell) and DYSGEUSIA (Partially lost taste). On 10-Apr-2021, LOSS OF CONSCIOUSNESS (Short time "everything come black"/ short time "black down") had resolved. On 11-Apr-2021, NIGHT SWEATS (Night time sweat), MUSCLE DISCOMFORT (Short time "lost control of muscle of neck"), DIZZINESS (Dizziness) and HEADACHE (Headache) had resolved. At the time of the report, PAIN IN EXTREMITY (Sore arm), HYPOSMIA (Partially lost smell) and DYSGEUSIA (Partially lost taste) outcome was unknown. The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown. Concomitant medications use was unknown. No treatment information was provided. Based on the current available information and temporal association between the use of the product and the start date of these events, a causal relationship cannot be excluded.; Sender's Comments: Based on the current available information and temporal association between the use of the product and the start date of these events, a causal relationship cannot be excluded.
20 2021-04-15 tremor Palpitations, sweaty and shakey. Began about a week after the second vaccine
20 2021-04-15 unresponsive to stimuli, cold sweat syncope, lightheadedness, dizziness, clammy skin followed by unresponsive, shallow breathing and sha... Read more
syncope, lightheadedness, dizziness, clammy skin followed by unresponsive, shallow breathing and shallow pulse. Appeared to be in shock
20 2021-04-16 numbness, cold extremities, tingling Patient started to feel chest tightness and tingling in his left arm. It then started to travel down... Read more
Patient started to feel chest tightness and tingling in his left arm. It then started to travel down his left leg. His arm was cold and numb at one point. He was concious but very confused and could not think straight. He had someone drive him to the ER. They did a CT scan, EKG, and other routine lab tests and all were normal. They attributed it to the vaccine.
20 2021-04-17 cold sweat At 5:00pm. Blood pressure was elevated to 137/91, No temperature noted even though he felt hot and c... Read more
At 5:00pm. Blood pressure was elevated to 137/91, No temperature noted even though he felt hot and clammy. Gave him water, and put legs on a pillow and he lay down At 6:30 he began to feel sweaty, clammy and included nausea. These episodes continues until about 8:30pm when he started to feel a bit better After a night of sleep that was restless and about 6hr long woke to feeling better but tired.
20 2021-04-18 pain in extremity . He received his second Moderna vaccine on 04/15th. He did have localized pain in his arm and the... Read more
. He received his second Moderna vaccine on 04/15th. He did have localized pain in his arm and the following day, had some headache and neck stiffness. Yesterday evening around 5 o' clock he developed left chest pain that has persisted. It has waxed and waned, but not disappeared. It reached an intensity of 7/10 prompting him to get a ride to the emergency room for evaluation. He was found to have myocarditis, with troponin elevation to 37 ng/mL, and globally reduced ejection fraction 45%. His care is ongoing.
20 2021-04-18 unresponsive to stimuli Several minutes after receiving 1st dose of Moderna patient fainted and slid from chair onto floor. ... Read more
Several minutes after receiving 1st dose of Moderna patient fainted and slid from chair onto floor. He was unresponsive for approximately 15-20 seconds and then regained consciousness. Pharmacist immediately took his blood pressure and it was 112/56. Patient stated that he was ok and had no trouble breathing. His grandmother accompanied him and they did not wish to call EMS. Patient was monitored for another 45 minutes and blood pressure was checked every 15 minutes where is was 122/64, 106/72, 107/78. After 45 minutes patient said he felt fine and wished to leave. Pharmacist accompanied patient to his car and grandmother drove him home.
20 2021-04-19 cold sweat, feeling cold, unresponsive to stimuli Patient had bowel movement after waking up and going to bathroom. He fainted, calling for help to hi... Read more
Patient had bowel movement after waking up and going to bathroom. He fainted, calling for help to his parents on his way down to the floor. Parents found him on floor cognitively responsives but not moving body (He does not remember anything after coming to kneel on floor). Parents found him clammy. Mother called 911 and was instructed to keep him lying on floor. He complained of being cold but was sweaty. Blanket placed over him on floor and kept there until EMS arrived. Patient c/o nausea. They got him into rolling chair and was going to leave when he had another episode of dizziness, clammy and nausea. EMS transported him to hospital. Blood work was done with no abnomalities noted. Upon discharge he complained of headache. Nausea dissipated upon eating and some ginger ale. Patient had previous had "covid arm" with first injection but no other complaints.
20 2021-04-20 numbness The ring finger on the left hand became numb on Saturday, 4/17/21, about 24 hours after the vaccinat... Read more
The ring finger on the left hand became numb on Saturday, 4/17/21, about 24 hours after the vaccination time of 4/16/21 at 1:30pm.
20 2021-04-21 weakness, slow speech Patient had a vaso-vagal like / syncope-like reaction. His color drained from his face and he head ... Read more
Patient had a vaso-vagal like / syncope-like reaction. His color drained from his face and he head was kind of limp, he responded to questions with great difficulty. He never lost consciousness. He stated like the room was fading away. We got him into the consultation room and had him lay down on the floor with his feet on a chair, to which he stated he felt better. The color came back to his face. He responded quicker to all questions and steadily improved. Next we moved him to legs straight, then sitting against the wall to sitting in a chair. Then he went back out the waiting chairs with his father.
20 2021-04-21 pain in extremity Patient fainted a few minutes after receiving first dose of Moderna. He regained consciousness with... Read more
Patient fainted a few minutes after receiving first dose of Moderna. He regained consciousness with 15-20 seconds. His blood pressure was taken at time of incident and was 112/56. He was monitored for 45 minutes after the event and blood pressure was taken every 15 minutes. He had no trouble breathing and recovered from the incident with no issues. He left with his grandmother and she did not wish to call EMS. Pharmacy called mom the next day to follow up and she stated that patient was doing fine other than having a sore arm.
20 2021-04-22 speech disorder Arm felt like styrofoam a few hours after injection for a day Severe sore throat started about 5 day... Read more
Arm felt like styrofoam a few hours after injection for a day Severe sore throat started about 5 days after Seen in urgent care 4/23. Hard to talk and swallow
20 2021-04-27 feeling hot, flushing Patient came to the pharmacy to get his first Moderna COVID vaccine today with his mom. After 15 min... Read more
Patient came to the pharmacy to get his first Moderna COVID vaccine today with his mom. After 15 minutes after receiving vaccine, he stated he felt dizziness, warmness, and flushing. I was able to elevate his feet and provide some cold water for him. After 10 minutes, he stated he felt his airway was getting closed and tongue was getting swollen. We decided to call 911 and provided Benadryl 50mg and Epipen for him. His blood pressure was 114/90 when EMS arrived. Since his vital was normal, EMS gave options to go to emergency room or urgent care. His mom and he chose to go to urgent care since he was getting better. I was able to follow up with his mom and he is going to take Benadryl for 2 days and follow up with Additional information for Item 18: his family physician. I will follow up with his doctor as well.
20 2021-04-27 pain in extremity Arm soreness, tinnitus is much louder, dizziness, nausea, insomnia, fatigue, loss of appetite, ... Read more
Arm soreness, tinnitus is much louder, dizziness, nausea, insomnia, fatigue, loss of appetite, diarrhea, On 4/27/21 I went to urgent care, they ran blood tests which showed possible signs of viral infection, was only prescribed zofran for the nausea and vomiting. Ears showed no outward sign of irritation or infection
20 2021-05-01 pain in extremity, muscle spasms SEVERE LEG CRAMPING AND PAIN TO THE POINT WHERE THE PATIENT CAN'T SLEEP. PATIENT HAS MISSED WORK 4 ... Read more
SEVERE LEG CRAMPING AND PAIN TO THE POINT WHERE THE PATIENT CAN'T SLEEP. PATIENT HAS MISSED WORK 4 DAYS SO FAR. CAN WALK BUT HURTS TO WALK.
20 2021-05-03 feeling cold, weakness I received the vaccine with no issues, within a few hours i experienced a minor headache. I went to ... Read more
I received the vaccine with no issues, within a few hours i experienced a minor headache. I went to class and woke up the next morning cold. I couldn?t get out of bed, I was weak, Nauseous, head was pounding. I was brought 800mg of ibroprofen and a thermometer. I temperature was a 103.7. I monitored my temperature all day long. My fever broke around noon, still sick. Around 3:00pm it returned at a 100.6. I went to bed for the day with the fever after taking more ibroprofen later that day and woke the next morning with a headache but other than that without symptoms. On today (May 4th) I still have a headache, but without symptom.
20 2021-05-03 feeling hot Sweaty, hot and ?felt like his vision was closing in on? him. DENIES SOB
20 2021-05-07 weakness patient developed chills, headaches, fatigue and unable to do normal school work tasks for 2 days du... Read more
patient developed chills, headaches, fatigue and unable to do normal school work tasks for 2 days due to weakness and nausea.
20 2021-05-07 pain in extremity, feeling cold Normal arm soreness following a vaccination throughout the day. Around 6 pm though I began to have m... Read more
Normal arm soreness following a vaccination throughout the day. Around 6 pm though I began to have minor body aches and shivers and I began to feel really cold (fever maybe). I bundled up and took some tylenol before I went to bed at around 10:30. When I woke up at 6:30 I didnt have any of those symptoms, just the arm soreness again, and even that was barely there
20 2021-05-07 tremor patient lost consciousness about 30 seconds after receiving the vaccine. Initially I treated it as a... Read more
patient lost consciousness about 30 seconds after receiving the vaccine. Initially I treated it as a syncopal episode and was just trying to wake him up but he began to shake (seizure-like) after about 15 seconds. I could not rule out anaphylaxis so I administered a dose of epinephrine via epipen. Patient regained consciousness approximately 5 to 10 seconds after epipen. EMS arrived approximately 10 minutes later and took patient to the hospital for further observation. Patient vomited on ambulance ride but did not lose consciousness again. Patient reportedly fine after being administered fluids but reports no memory of ambulance ride or even being vaccinated.
20 2021-05-08 numbness pt reported numbness, weaknees in arms, extreme fatigue, slight shortness of breath above baselines.
20 2021-05-10 pain in extremity Fever-+39 degrees Celcius, and I had never experienced even a headache before I took the vaccine. Se... Read more
Fever-+39 degrees Celcius, and I had never experienced even a headache before I took the vaccine. Severe arm pain-Almost like a broken arm Luckily, I am better at day #2. Very grateful that I took the vaccine, and the US gave me the opportunity to do so. However, to contribute to research and data, I wanted to report what I experienced.
20 2021-05-11 cold sweat I ran a fever, was in cold sweats all night long, vomited, and had an extremely high heart rate. I h... Read more
I ran a fever, was in cold sweats all night long, vomited, and had an extremely high heart rate. I have honestly never been so sick in my life but it did settle out a bit. Now I just feel exhausted and have a headache. I've been feeling better and better but I felt as though it was worth reporting.
20 2021-05-12 tremor The night that I got the vaccine I got inflammation in my lower spine. I lost feeling in my lower le... Read more
The night that I got the vaccine I got inflammation in my lower spine. I lost feeling in my lower legs. I could still move my legs, but they were numb. There were also a few moments of pain but mostly numbness. It lasted for two days. I was taking Ibuprofen and icing my lower back and the feeling slowly returned to my lower legs. The numbness was in both legs all the way to the hip. I also had lower back pain which went away at about the same time as I regained the feeling in my legs. After the second dose of the vaccine I had severe shaking and I passed out.
20 2021-05-17 flushing Post vaccine administration, about 2-3 minutes later, patient reported numbness at injection site an... Read more
Post vaccine administration, about 2-3 minutes later, patient reported numbness at injection site and increased warmth radiating to near chest/axillary region. Pt was able to speak clearly, no anaphylaxis. Pt was able to move fingers/arm but numb to injection site. Contacted paramedics who took BP and advised pt to go to hospital - pt declined paramedic escort and volunteered to be driven to hospital by self/guardian
20 2021-05-17 seizure, unresponsive to stimuli, flushing Systemic: Confusion-Medium, Systemic: Dizziness / Lightheadness-Severe, Systemic: Fainting / Unrespo... Read more
Systemic: Confusion-Medium, Systemic: Dizziness / Lightheadness-Severe, Systemic: Fainting / Unresponsive-Severe, Systemic: Flushed / Sweating-Medium, Systemic: Seizure-Medium
20 2021-05-18 cold sweat Stood up to go to the observation chair after getting vaccine. After sitting down at observation are... Read more
Stood up to go to the observation chair after getting vaccine. After sitting down at observation area, heart rate seemed to drop/become abnormal, and I began to lose hearing, and vision began to get fuzzy. The pharmacist accompanied me as I was experiencing symptoms, talking me through things. I then began to get profuse cold sweats, after which I asked for water. After drinking a bottle of water and not moving for about 15 minutes, everything turned to relative normalcy. I was able to walk home afterwards.
20 2021-05-18 feeling hot Patient described feeling very hot all of a sudden and then they passed out. Patient was lowered to... Read more
Patient described feeling very hot all of a sudden and then they passed out. Patient was lowered to the ground and was responsive within seconds. Patient had a history of passing out once before after a vaccine administration. They had received other vaccines since without issue. Patient was given a cool compress and felt better within a few minutes. Patient waited for extra time once they were able to stand up and felt good.
20 2021-05-18 unresponsive to stimuli Systemic: Fainting / Unresponsive-Mild
20 2021-05-19 pain in extremity Began night of vaccine, arm was warm , woke up 05/18/2021 L arm was in pain and hot... , later that... Read more
Began night of vaccine, arm was warm , woke up 05/18/2021 L arm was in pain and hot... , later that night he felt nausea.. chest tightening , SOB , pain was intermittent and becoming progressively worse. 05/19/2021 - Underneath his L arm the swelling has increased, with pain and warm. Chest tightness and SOB is intermittent.
20 2021-05-21 flushing Systemic: Fainting / Unresponsive-Mild, Systemic: Flushed / Sweating-Mild.
20 2021-05-22 pain in extremity lymph nodes swollen in armpit, pain, lump at injection site, patient arm sore
20 2021-05-26 cold sweat Patient recevied COVID vaccine and while waiting in lobby became lethargic, clammy, discolored, and ... Read more
Patient recevied COVID vaccine and while waiting in lobby became lethargic, clammy, discolored, and was unconcious for about 30 seconds Mother states first vaccine he did not get a reaction just was sleepy. Stated he had Leukemia and has been in remission for the last 10 years.
20 2021-05-27 seizure Systemic: Confusion-Mild, Systemic: Dizziness / Lightheadness-Mild, Systemic: Seizure-Medium, System... Read more
Systemic: Confusion-Mild, Systemic: Dizziness / Lightheadness-Mild, Systemic: Seizure-Medium, Systemic: Vomiting-Severe
20 2021-05-31 seizure Pt received his first dose of the Moderna Covid-19 vaccine. Immediately following the injection the ... Read more
Pt received his first dose of the Moderna Covid-19 vaccine. Immediately following the injection the pt began convulsing. Convulsions lasted for less than 30 seconds. Upon completion of convulsions pt was awake and alert. He stated he was thirsty. Before we could provide water to pt, the pt began vomiting. Pt was placed on his side and paramedics were called. Pt remained in a laying position until emt's arrived. Pt was examined and released. Pt was encouraged to follow up with his pcp.
20 2021-06-02 pain in extremity patient stated that 1-2 days after immunization their arm become inflamed and almost purple. It was ... Read more
patient stated that 1-2 days after immunization their arm become inflamed and almost purple. It was painful and has slowly returned to normal. Some nerve sensations are felt.
20 2021-06-06 numbness, tremor, feeling hot FEEL HOT, NUMB ALL OVER, SHAKING. BP 124/95, HR 100-110. EMS CAME, OFFERED GATORADE, SX STILL PERSIS... Read more
FEEL HOT, NUMB ALL OVER, SHAKING. BP 124/95, HR 100-110. EMS CAME, OFFERED GATORADE, SX STILL PERSISTS, TRANSPORTED TO HOSPITAL
20 2021-06-07 unresponsive to stimuli, seizure Approximately 2-3 minutes after receiving the shot patient reports that he had a seizure. Was sittin... Read more
Approximately 2-3 minutes after receiving the shot patient reports that he had a seizure. Was sitting in the observation area, felt like vision was blacking out. Observers report that patient stiffened in chair and eyes rolled back. No one observed tonic-clonic movements of limbs, but patient did have bladder incontinence. He was unresponsive for several minutes, EMS was called and evaluated patient at the scene. He started to feel better fairly quickly after regaining consciousness and refused transport to hospital.
20 2021-06-08 numbness, tremor, feeling hot FEEL HOT, NUMB AND SHAKING ALL OVER BODY, BP 124/95, HR 100-110, GATORADE GIVEN, ALSO HAS CARPAL AND... Read more
FEEL HOT, NUMB AND SHAKING ALL OVER BODY, BP 124/95, HR 100-110, GATORADE GIVEN, ALSO HAS CARPAL AND PEDAL SPASMS. TRANSPORTED TO HOSPITAL
20 2021-06-09 pain in extremity "After my first dose, about 24 hours later, I began my onset of symptoms. I developed a low-grade fe... Read more
"After my first dose, about 24 hours later, I began my onset of symptoms. I developed a low-grade fever, chills, and whole arm soreness around the injection site. After taking off and some Tylenol, my symptoms quickly recovered almost as quickly as they came."
20 2021-06-09 unresponsive to stimuli Systemic: Fainting / Unresponsive-Mild, Additional Details: Patient lost conscious on his way out of... Read more
Systemic: Fainting / Unresponsive-Mild, Additional Details: Patient lost conscious on his way out of the store down aisle 2. Mother screamed for help. When I went over patient was alert and responsive. Asked patient and mother if they prefer I call an ambulance, both declined. Patient states no history of syncope after injections. Had him transition from lying on floor to sitting on floor, then sitting on chair, and then eventually standing on his own. Patient stated he felt fine and was ok to go home.
20 2021-06-12 tremor Pt was having anxiety after vaccine and was having little shakiness/light head. He was fine in few m... Read more
Pt was having anxiety after vaccine and was having little shakiness/light head. He was fine in few minutes. He said he always had fear with needles and anxiety in past. Mother was there with him all the time. He was feeling fine in few minutes. Gave him some ice packs and his feet were elevated. I asked him if he/mother wants us to call paramedics, but they denied. He was able to talk - he said it's just his anxiety, he is feeling fine otherwise. Pt left the store after few minutes with mother.
20 2021-06-13 weakness HISTORY OF PRESENT ILLNESS: This is a 20-year-old male with past medical history of asthma, who was ... Read more
HISTORY OF PRESENT ILLNESS: This is a 20-year-old male with past medical history of asthma, who was brought to ED by ambulance for nausea, vomiting, generalized weakness, and fever. The patient received his second dose of Moderna vaccine 10 days ago. The patient is experiencing symptoms of nausea, vomiting, fatigue, poor p.o. intake for the last few days. He was at ED 4 days ago and had a negative workup. The patient had a fever with T-max of 103 at home. He also had 2 episodes of emesis in the last few days. He denies any diarrhea, chest pain, abdominal pain. He complains of headache. He denies any blurred vision or neck stiffness. At hospital, the patient was given 4 L of fluid and had multiple blood tests. Even echocardiograms were unremarkable. The patient is unable to ambulate because of generalized weakness and dizziness.
20 2021-06-15 flushing Systemic: Chills-Medium, Systemic: Dizziness / Lightheadness-Medium, Systemic: Fainting / Unresponsi... Read more
Systemic: Chills-Medium, Systemic: Dizziness / Lightheadness-Medium, Systemic: Fainting / Unresponsive-Severe, Systemic: Flushed / Sweating-Medium, Systemic: Hypotension-Medium, Additional Details: Less than 5 minutes after receiving vaccination pt reported feeling lightheaded. During observation patient lost conciousness for <1min. Patient awoke with chills, sweating, and continued lightheadedness. These symptoms abated during observation and after 30 minutes patient was sent home for rest in a quiet dark room.
20 2021-06-16 seizure like phenomena Vaccine was administered to patient. He had a history of fear of needles, fainting, etc. Approxima... Read more
Vaccine was administered to patient. He had a history of fear of needles, fainting, etc. Approximately 5 minutes after administration, patient did faint with possible seizure activity. Paramedics were called. No further adverse events were observed. Patient was conversational and walked out on his own power.
20 2021-06-18 cold sweat, migraine I had no symptoms after receiving the first dose, but after receiving the second dose I developed a ... Read more
I had no symptoms after receiving the first dose, but after receiving the second dose I developed a high fever of 103 degrees as well as body aches, hypersensitivity, dizziness, migraines, and diarrhea. I eventually began taking ibuprofen to manage the symptoms, starting on night one. I then usually took ibuprofen twice a day after that. My symptoms were completely treated by ibuprofen and nearly all of them disappeared when I took it, besides the diarrhea. Oddly I also developed cold sweats when taking ibuprofen, which would dissipate after the ibuprofen stopped working. The symptoms kept coming back, as far as a week later, however, I didn?t have to take as much ibuprofen as before because they were becoming intermittent. Today, I almost got through the whole day without a return of any of my symptoms, until about 11:00 PM, after which all symptoms came back, the difference being that my fever is now low grade. This has been the case for two days now, no symptoms until night, when they all return promptly.
20 2021-06-23 cold sweat AFTER RECEIVING HIS 2ND DOSE MODERNA VACCINE, THE PATIENT SAT IN THE OBSERVATION AREA. 5 MINUTES IN... Read more
AFTER RECEIVING HIS 2ND DOSE MODERNA VACCINE, THE PATIENT SAT IN THE OBSERVATION AREA. 5 MINUTES IN THE OBSERVATION AREA, THE PATIENT CAME TO OUR COUNTER TO ALERT ME THAT HE FELT DIZZY. I IMMEDIATELY ASKED HIM TO SIT BACK DOWN, AND CAME OUT TO HIS SIDE. HE THEN TOLD ME THAT HIS DIZZINESS SYMPTOM INTENSIFIED. HIS BODY SUDDENLY SHOOK A BIT, I HELD ON TO HIM TO KEEP HIM STEADY. THEN I HAD HIM SAT DOWN ON THE FLOOR, THEN HE TOLD ME HE NEED TO LIE DOWN. SO I HELP HIM LAY DOWN. HIS SKIN STARTED TO FEEL VERY DAMP. HE SAID HE FELT EXTREMELY NAUSEOUS. I HAD MY TECHNICIAN CALL 911 FOR HIM, I REMAINED WITH HIM BY HIS SIDE THE WHOLE TIME UNTIL PARAMEDIC GOT TO US IN 8 MINUTES. THEY TOOK HIS VITAL SIGNS. EVERYTHING CHECKED OUT. HE DIDNOT GO TO THE HOSPITAL. PARAMEDICS LEFT. HIS MOM CAME TO PICK HIM UP. HE FELT NAUSEOUS FOR THE NEXT 5 HOURS, THEN HE SLOWLY FEELING BETTER.
20 2021-06-28 pain in extremity I had a high fever 12 hours after the vaccine, that only lasted for a day arm ached a couple of days... Read more
I had a high fever 12 hours after the vaccine, that only lasted for a day arm ached a couple of days, very fatigued for a week after the vaccine.
20 2021-06-29 seizure, flushing Systemic: Dizziness / Lightheadness-Medium, Systemic: Flushed / Sweating-Severe, Systemic: Seizure-M... Read more
Systemic: Dizziness / Lightheadness-Medium, Systemic: Flushed / Sweating-Severe, Systemic: Seizure-Medium, Additional Details: Pt had a seizure about 3 minutes after receiving the second Moderna vaccine. He previously reported to adverseve reaction with 1st vaccine. Per mom who is a RN, pt first stated that he was lightheaded and she had him sit down. Then his eyes rolled back and he had a seizure. Mom shouted to me that he was having a reaction and she called 911 from her cell phone. A few minutes later he was able to talk to his as we waited for the paramedics.
20 2021-06-30 hot flush, unresponsive to stimuli He had the vaccine on 05/12/2021. It started at 1 am, he had a pretty normal night, he went to bed a... Read more
He had the vaccine on 05/12/2021. It started at 1 am, he had a pretty normal night, he went to bed and woke up vomiting, that continued through the night, the vomiting continued, he had a head ache, he called me and told me that his stomach really hurt, I told him to check his blood sugar, he also had hot flashes, chills, and body aches, but mainly he had vomiting, then the next day 5/14/2021 he was getting more sleepy and less responsive, his friends tried to give him water and different things, his blood sugar went up, his friends took him that afternoon to the ER because he started not responding to me, his friends would tell me he was sleeping, so they took him to the ER, they found that he was very dehydrated, they were giving him fluids and did blood work, he was very unresponsive when he arrived, he could not answer his questions, he had a friend that was there that told them he had the vaccine, the blood work said he had a very high white blood cell count they were worried he had sepsis, they found his kidneys were not working ok, because his levels were very crazy and chest pain and severe stomach pain, and he had pancreatitis, they ruled out a heart attack, he then was admitted because he was in DKA, diabetic keto acidosis, like a result of his type 1 diabetes that got flared up because of all his reactions. They admitted him to the ICU and he was there until 05/16/2021 and basically they were just giving him fluids, potassium and other things to help his body calm down and stabilize his blood sugar. He was released and he still continues that his heart hurts but doctors say that these things resolve after a while.
20 2021-07-01 tingling Cardiac arrhythmia, tingling in head, brain fog, dysautonomia, light sensitivity, tachycardia with a... Read more
Cardiac arrhythmia, tingling in head, brain fog, dysautonomia, light sensitivity, tachycardia with any exertion.
20 2021-07-01 tremor Patient Experienced pain when receiving the vaccination and started shaking/fingers and fingernails ... Read more
Patient Experienced pain when receiving the vaccination and started shaking/fingers and fingernails started to turn blue. Recorded temperature was 97 and gave patient orange juice. Patient stayed in store for about 20 minutes and felt better. Shaking resolved but finger was still blue. Patient's father took son to medical facility afterwards.
20 2021-07-04 discomfort After both vaccinations for COVID-19 (Moderna: First dose - 4/15/2021, Second dose (05/18/2021, I ex... Read more
After both vaccinations for COVID-19 (Moderna: First dose - 4/15/2021, Second dose (05/18/2021, I experienced swollen lymph nodes in my armpit and collarbone on the vaccinated side of my body (Right side). Swelling of lymph nodes occurred around 18-24hrs after the vaccination and remained for about 5-7 days. This swelling resulted in varying levels of discomfort (worse in the days shortly after vaccination) when engaging the muscles and tendons around my armpit, feeling like the lymph node was being ?pulled?. Around 2 months after second vaccination (today), there is no pain or discomfort, but I can still feel the lymph node in my right armpit versus being unable to in my left armpit.
20 2021-07-05 muscle spasms My son got the second vaccine shot at work and he works I don't know the lot number or any of those ... Read more
My son got the second vaccine shot at work and he works I don't know the lot number or any of those types of numbers
20 2021-07-09 seizure like phenomena After receiving his vaccine, pharmacist advised for the patient to sit down in a chair for 15 minute... Read more
After receiving his vaccine, pharmacist advised for the patient to sit down in a chair for 15 minutes for observation. 5 minutes after receiving his 2nd Moderna vaccine, the patient passed out in the chair for approximately 5-10 seconds. It was observed by our employee that he made a gurgling sound and a weird body movement, similar to a seizure. His eyes were closed and his body is sluggish on the chair. He was able to open his eyes back up and realized what happened. He was conscious, alert, and able to answer any questions after the event.
20 2021-07-13 weakness, flushing, tremor, unresponsive to stimuli Systemic: Confusion-Mild, Systemic: Dizziness / Lightheadness-Severe, Systemic: Fainting / Unrespons... Read more
Systemic: Confusion-Mild, Systemic: Dizziness / Lightheadness-Severe, Systemic: Fainting / Unresponsive-Severe, Systemic: Flushed / Sweating-Severe, Systemic: Nausea-Severe, Systemic: Shakiness-Severe, Systemic: Vomiting-Severe, Systemic: Weakness-Severe, Additional Details: Patient approached pharmacy and appeared normal/healthy. Vaccine was mixed/prepared/given proper protocol. Patient sat down after vaccination and within 5-10 minutes he fainted face forward from a seated position. He regained consciousness within 30 seconds of fainting. He then vomited within minutes after he sat up after fainting. A nurse practitioner was in store shopping and stopped by to read his blood pressure (135/76) then the EMT arrived within a minute of the blood pressure reading.
20 2021-07-13 facial paralysis, bell's palsy the client receives allergy shots every 2 weeks. On 5-21-21 he received his first moderna vaccine wi... Read more
the client receives allergy shots every 2 weeks. On 5-21-21 he received his first moderna vaccine with no problem. He received an allergy shot on 6-15-2021. On 6-16-2021, he experienced tingling on the left side of the tongue. His symptoms increased to being unable to smile on the left, unable to control blinking on the left. On 6-18-21 he went to Urgent Care and was diagnosed with Bell's Palsy and started on prednisone for 16 days. He reports that his symptoms subsided in 2 weeks before completing the prednisone.
20 2021-07-20 involuntary muscle movements Just finished administering the Moderna vaccine and whilst still having a conversation with the pati... Read more
Just finished administering the Moderna vaccine and whilst still having a conversation with the patient I was about to start the clock on the timer to monitor the patient when his eyes rolled over, the patient slumped in his chair and fell to the floor. He jerked twice then his eyes opened and he looked very confused trying to figure out where he was. I let him stay on the floor for about two minutes and then I helped him get up and sit back into his seat. I monitored him for 30 minutes. There was no difficulty in breathing, shortness of breath or tightening of the airways. No swelling of the face or other sites of the body where observed. The patient was able to carry out a normal conversation. Once the 30 minutes where I released the patient and advised him to get in touch with his primary care physician, Dr.
20 2021-07-20 muscle spasms Muscle weakness, pain, cramping. No change with D/C statin or addition od CoQ10
20 2021-07-20 unresponsive to stimuli, flushing, tingling Systemic: Dizziness / Lightheadness-Medium, Systemic: Fainting / Unresponsive-Mild, Systemic: Flushe... Read more
Systemic: Dizziness / Lightheadness-Medium, Systemic: Fainting / Unresponsive-Mild, Systemic: Flushed / Sweating-Medium, Systemic: Nausea-Mild, Systemic: Tingling (specify: facial area, extemities)-Mild
20 2021-07-21 weakness projectile vomiting dizziness weakness
20 2021-07-22 flushing, unresponsive to stimuli Systemic: Dizziness / Lightheadness-Mild, Systemic: Fainting / Unresponsive-Mild, Systemic: Flushed ... Read more
Systemic: Dizziness / Lightheadness-Mild, Systemic: Fainting / Unresponsive-Mild, Systemic: Flushed / Sweating-Mild, Systemic: Hypotension-Mild, Additional Details: pt fainted after receiving second dose of vaccine; lack of food in stomach plus cannabis inhalation earlier in the morning
20 2021-07-25 flushing patient felt lightheaded, dizzy, flush, sweating - after sitting and drinking some water over 20 m... Read more
patient felt lightheaded, dizzy, flush, sweating - after sitting and drinking some water over 20 minutes pt began to feel better
20 2021-07-25 pain in extremity palpitations o going since july 20 arm pain
20 2021-07-25 seizure patient fell down and started convulsing
20 2021-07-26 seizure Patient stated that he didn't feel well then his pupils dilated, his eyes rolled back in his head an... Read more
Patient stated that he didn't feel well then his pupils dilated, his eyes rolled back in his head and he seized for approximately 15 seconds. Afterwards his pupils remained dilated and fixed until he regained consciousness. Patient was assisted to the floor where we waited for paramedics to arrive. The patient stated he was okay and refused to go with paramedics.
21 2020-12-31 pain in extremity Itchy eyes. Resolved with 25 mg benadryl. Sore arm for three days. Chilly off and on for three days... Read more
Itchy eyes. Resolved with 25 mg benadryl. Sore arm for three days. Chilly off and on for three days. Still some tired on third day. Does not know if this is related, but an old boil site started bleeding off and on and has not stopped.
21 2021-01-06 migraine Sore arm after injection about 12 hours after that lasted a full day or longer. Severe headaches and... Read more
Sore arm after injection about 12 hours after that lasted a full day or longer. Severe headaches and migraines approximately 2 days after injection. 5-6 Days after vaccine developed swollen lymph nodes in right arm pit and intermitten pain to move arm that lasted for 2-3 days.
21 2021-01-12 feeling hot Moderna COVID-19 Vaccine EUA I received the first dose of my vaccine at about 8:30am on January 12. ... Read more
Moderna COVID-19 Vaccine EUA I received the first dose of my vaccine at about 8:30am on January 12. Around 6pm on January 12 I started to experience chills. As the night went on the chills got worse and I developed a terrible throbbing headache. In addition to that I was feeling hot and sweating profusely. I fell asleep around 10pm and woke up around 11pm, at this time the headache was worse, the chills were getting better, and I was still hot and drenched in sweat. I was able to fall back to sleep shortly after. I then woke up at 1am on the 13th, I still had a headache, the chills were gone, I was still hot and sweaty. At this time I also started vomiting. I preceded to vomit until there was nothing left in me and went back to bed. I woke up at 3am and proceeded to dry heave as there was nothing left to come up. My headache was extremely bad at this point and I was still hot and sweaty. I could not keep down Tylenol so I used a cold wet rag to help with the headache. I was finally able to sleep again. I woke up at 5am still with a headache and still hot at this time I was able to take my temperature and it was 99.8. I fell asleep again and woke up at 9am with a temperature of 100.1, at this time I was able to take Tylenol and keep it down which broke my fever and alleviated the headache. Now at about 1pm on the 13th I am still only able to sip liquids and my stomach is upset. This was the sickest I have been in a long time. I have spoken on the phone with a triage nurse at my doctors office and I am waiting for her to consult with a doctor and call me back.
21 2021-01-12 feeling jittery Patient reported feeling jittery after the vaccine; however, it resolved in 15 minutes. Patient cle... Read more
Patient reported feeling jittery after the vaccine; however, it resolved in 15 minutes. Patient cleared by EMS. . Instructed patient to call his family physician, 911, or go to the nearest emergency room for any further issues.
21 2021-01-13 seizure, involuntary muscle movements per report via email - patient receive COVID vaccine during staff clinic in the AM. During the even... Read more
per report via email - patient receive COVID vaccine during staff clinic in the AM. During the evening patient started to feel sick. symptoms included: nausea/vomiting, uncontrollable jerk like seizures, very disoriented, respirations ragged and rapid. Family called 911 taken via ambulance to local ER. per report patient received IV fluids, medicine to treat nausea/vomiting and meds to "get his respirations under control". patient sent home and is now resting.
21 2021-01-17 tingling 14 days post vaccination developed: chest pain, back pain, paresthesia of bilateral upper extremiti... Read more
14 days post vaccination developed: chest pain, back pain, paresthesia of bilateral upper extremities. CXR, EKG and Lab work done. Symptoms not disabling yet present; musculoskeletal pain in upper extremities with paresthesia
21 2021-01-20 pain in extremity Headache and pain in arm that injection was given in then passed out
21 2021-01-26 pain in extremity patient is reporting very sore arm and headache and is now complaining of shortness of breath
21 2021-01-27 bell's palsy Bells Palsy. Onset approx 8 hr post vaccination
21 2021-02-04 weakness Pt c/o Headache, dizziness, body aches, weakness starting last night, and symptoms got worse this mo... Read more
Pt c/o Headache, dizziness, body aches, weakness starting last night, and symptoms got worse this morning. Pt received 1st vaccine dose 05 Jan, 2nd dose 3 Feb. Pt denies sob/v. No Known Drug Allergies CHIEF COMPLAINT & HPI: 21 yo M with Headache, dizziness, body aches, weakness starting last night, and symptoms got worse this morning. Pt received 1st vaccine dose 05 Jan, 2nd dose 3 Feb. Pt denies sob/v.
21 2021-02-04 pain in extremity I obtained my booster shot on my left deltoid at 2:30 PM 2/4/2021. I had slight soreness in my arm t... Read more
I obtained my booster shot on my left deltoid at 2:30 PM 2/4/2021. I had slight soreness in my arm til 8:00 which the soreness disappeared. Around 2:00 AM, I was awakened by a pounding headache, fever of 102, and my upper left chest (unilateral between the midline of my left chest and the axillary region) started to hurt. I took Tylenol 1000 mg at 3 and took a hot bath (recommended by friend who also displayed a fever and headache). After a while, my fever began to lower but my headache and chest pain did not disappear and I could not sleep until 7 AM. I woke up today (2/5/2021) at 10 AM with a fever of 101.4, another pounding headache, and still unilateral chest pain. I took another 1000 mg of Tylenol around 10:30 AM and it only helped with the fever. I went back to sleep and slept until 4 PM. I understand that the fever and headache are normal symptoms but my chest pain does not seem like muscle soreness. It doesn't hurt when I touch it, it comes and goes every few seconds, I have 4 or 5/ 10 on the pain scale for most of the pain but it turns into 6 or 7/10 occasionally (10 being the worst pain). What does help with my pain when it is 6 or 7/10 is when I clench my chest really hard like I am flexing it. It is a sharp pain that stays for a few seconds before it disappears and it feels like a deep pain. I didn't want to take Tylenol again because I am about to max out (can only take 2 more capsules until 2:00 AM because it states not to take more than 6 capsules in 24 hours, and each capsule is 500 mg) (Also, the Tylenol does not help with the pain so I am only taking it for my fever.) I was wondering if anyone else reported this and if this is an adverse side effect. This has not cause any issues regarding my breathing but just pain.
21 2021-02-11 numbness, tingling Face numb/tingling. Right arm numb/tingling
21 2021-02-15 weakness started to have a headache the day after the shoot, tried to sleep it off. Had chills and felt sligh... Read more
started to have a headache the day after the shoot, tried to sleep it off. Had chills and felt slightly weak. Went away after the day after the side affects.
21 2021-02-16 seizure Patient had seizure about 45 minutes after receiving Covid 19 vaccine. Dr at ER confirmed this seiz... Read more
Patient had seizure about 45 minutes after receiving Covid 19 vaccine. Dr at ER confirmed this seizure was not related to Covid vaccine. Patient didn't take Depakote for 2 days. His Depakote level was low. Patient has history of brain tumor and seizure.
21 2021-02-22 feeling cold Chills, body ache, fatigue
21 2021-02-27 pain in extremity, migraine About 4 hours after getting vaccine, I started to get a headache and my injection arm started hurtin... Read more
About 4 hours after getting vaccine, I started to get a headache and my injection arm started hurting. Then a couple hours after, my skin got sensitive and burning. My muscles started hurting. 10 or 11 hours after getting the vaccine, I got severe chills; migraine; fever; nausea; dizziness. Symptoms lasted through the night. Fever went away 24 hours after receiving vaccine. 14 hours after getting vaccine, headache, arm ache, and body soreness remains.
21 2021-02-28 tingling tingling on right side of arm and lips monitored vital signs all WNL, assessed for signs of stroke ... Read more
tingling on right side of arm and lips monitored vital signs all WNL, assessed for signs of stroke none present felt better and left after speaking with MD
21 2021-03-03 numbness Patient tolerated vaccine fine with no immediate reaction or issues, waited normal 15 minutes and th... Read more
Patient tolerated vaccine fine with no immediate reaction or issues, waited normal 15 minutes and then left. Approximately 2 hours post vaccination the patient started experiencing leg numbness in her left leg. She stated it felt like "jello" and was weak. She declined the option to immediately return to the clinic for a provider evaluation. She stated no trouble breathing of any kind. She said she had consulted her oncologist and "healthcare team". She did mention her specialist was pausing some of her medications in order to receive the covid vaccine and that she had okayed her to receive it.
21 2021-03-03 pain in extremity Vaccine was Moderna COVID-19 Vaccine EUA 4 days after receiving the vaccine, two hours after I woke ... Read more
Vaccine was Moderna COVID-19 Vaccine EUA 4 days after receiving the vaccine, two hours after I woke up, I began to have mild chest pain in the center of my chest. After that, the pain started to grow and grow until it was extreme pain, at around an 8/10. The pain radiated from my chest to the undersides of my arms. After two hours of pain, it started to subside and eventually was gone. There was no pain for the rest of the day. The next day, two hours after I woke up again, the mild chest pain returned. Still in the center of my chest, the pain grew into extreme pain again. This time however, it was slightly to the right and as the pain progressed it moved right until after two hours it went away again. The treatment I got at the Urgent Care was an EKG and they told me to go to a hospital. At the hospital, I got Toradol, aspirin and propanolol. My initial Troponin levels at admission to the hospital were 900 and grew to 1300. It lowered for a time, but at the last check, it rose again to 1420 after not getting Toradol for at least 12 hours.
21 2021-03-06 seizure Patient experienced a generalized seizure lasting at least two minutes on Jan. 14th, having received... Read more
Patient experienced a generalized seizure lasting at least two minutes on Jan. 14th, having received the vaccine on Jan. 6th. Patient has no history of seizure disorder. Patient was taken to the ER per his physician's order. CT scan, x-ray and blood work were unremarkable except for an elevated whilte blood cell count. Patient was released and convalesced at home. There has been no further seizure activity. Patient did not recieve the second dose of the COVID19 vaccine.
21 2021-03-07 pain in extremity patient stated that he had some arm pain which started to get better after Tylenol, nausea / vomitin... Read more
patient stated that he had some arm pain which started to get better after Tylenol, nausea / vomiting , dizziness, and chills
21 2021-03-09 numbness, tingling Patient began reporting numbness and tingling in his left arm several minutes after vaccination. The... Read more
Patient began reporting numbness and tingling in his left arm several minutes after vaccination. These symptoms persisted for 30 minutes without worsening or lessening. He did not have any SOB, syncope or other symptoms. Physical exam WNL. Pt was instructed to seek ER care for worsening symptoms. His mother was present with him today and will keep an eye on him as well.
21 2021-03-14 tingling, feeling hot 3:42 pm Pt received vaccination, stood up and c/o of feeling light headed, dizzy and body tingles. H... Read more
3:42 pm Pt received vaccination, stood up and c/o of feeling light headed, dizzy and body tingles. He became diaphoretic, pale and warm. Vaccinator put ice pack to back of neck, brought to recovery area in wheel chair VS 120/78, HR 81 reg, resps 16 regular non labored, 96% O2 sat. gave water to hydrate. no c/o N/V Monitored for 30 min Pt state he felt better, tingles diminished, color came back to face, no more diaphoresis. Provided reassurance. Encourage hydration. V-safe site. Ok'd to leave site. RN 3/9/21 - called pt to check condition he stated he is doing very well. RN
21 2021-03-16 feeling cold Aches, nausea, chills, sensitivity to cold, occasional headaches
21 2021-03-20 muscle spasms Soreness and swelling at injection site for 1 day after both injections. Lasted only for the day fol... Read more
Soreness and swelling at injection site for 1 day after both injections. Lasted only for the day following injection. After dose 2, massive headache, fatigue, muscles cramps beginning the morning after vaccination. Most concerning is my heart has been aching and possibly beating out of rhythm. Report submitted night of 2nd day after vaccination. Side effects not subsiding.
21 2021-03-24 seizure 3 seizures 2 minutes apart lasting a few seconds. EMS called and he was transferred to the hospital... Read more
3 seizures 2 minutes apart lasting a few seconds. EMS called and he was transferred to the hospital. BP:117/72 98% 66 Pulse
21 2021-03-30 weakness violent throwing up, nauseau and weakness. Began 3 hours after the shot.
21 2021-03-30 seizure PT COLLAPSED AND FELL ON THE FLOOR FACE DOWN ABOUT 5 MINUTES, AROUND 9:35AM AFTER GETTING 1ST DOSE ... Read more
PT COLLAPSED AND FELL ON THE FLOOR FACE DOWN ABOUT 5 MINUTES, AROUND 9:35AM AFTER GETTING 1ST DOSE OF COVID VACCINE. PT WAS TURNED OVER WITH THE HELP OF A SAMARITAN WHILE WE CALLED 911. PT HAD SEVERAL SEIZURE EPISODES. PT REGAINED CONSCIOUSNESS AND BECAME RESPONSIVE AFTER ABOUT 2 MINUTES. PARAMEDICS CAME AND TOOK OVER. PER PT, NO PRIOR HISTORY OF SEIZURE OR MEDICAL CONDITION. PT CAME FROM 10 HRS NIGHT SHIFT (2 DAYS IN A ROW) TO GET HIS VACCINE. DAD WAS INFORMED PER PT'S AUTHORIZATION ABOUT INCIDENT AND HE SAID HE WILL BE ON HIS WAY. PT TO BE TRANSPORTED TO A NEARBY HOSPITAL PER ONE OF THE PARAMEDICS.
21 2021-03-31 seizure A spontaneous report was received from a consumer (United States) concerning a 21-year-old, male pat... Read more
A spontaneous report was received from a consumer (United States) concerning a 21-year-old, male patient who received Moderna's COVID-19 vaccine (mRNA-1273) and experienced fell out of the chair and passed out/Loss of consciousness, fell out of the chair and passed out/Fall, may have been a seizure but unsure/seizure. The patient's medical history included psychological problems. Concomitant product use was not provided by the reporter. On an unknown date, prior to the onset of the events, the patient received their first of two planned doses of mRNA-1273 (Batch number unknown) intramuscularly for prophylaxis of COVID-19 infection. On an unknown date, after the injection he "fell out of the chair and passed out". The reporter stated that she heard it "may have been a seizure but unsure". She reported the male was obese. The events passed out and seizure was considered as medically significant. Treatment information was not provided. Action taken with mRNA-1273 in response to the events was not provided. The outcome of the events fell out of the chair and passed out, may have been a seizure but unsure was unknown at the time of this report.; Reporter's Comments: Very limited information regarding these events has been provided at this time. Further information has been requested.
21 2021-03-31 unresponsive to stimuli Pharmacy staff was alerted by patient's girlfriend that he had passed out. I went to the waiting are... Read more
Pharmacy staff was alerted by patient's girlfriend that he had passed out. I went to the waiting area where she was propping him up in a chair. Patient was not responsive and completely limp. Together we lowered him to the floor where he quickly began to regain consciousness and tried to sit up. Patient was fairly alert within 1-2 minutes. Patient was given water, ice packs for the back of his neck and forehead, and ED was called. Patient stated he was feeling much better and did not need EMS, but due to store policy they were called. Patient relayed a history of fainting after receiving tattoos, that was not notated on his form. Patient remained on floor until EMS arrived about 20 minutes later and checked on patient. Patient's heart rate and BP were taken by EMS laying down, sitting, and standing and was cleared by EMS to leave.
21 2021-04-03 pain in extremity My left arm was sore starting a few minutes after the vaccine. This soreness last through that night... Read more
My left arm was sore starting a few minutes after the vaccine. This soreness last through that night. When I woke up the next day, my arm was extremely sore and I was very dizzy. Additionally, my pulse felt fast but my heartbeat seemed to have less strength. My breathing felt more shallow like I wasn't getting as much oxygen from the air that I breathed in as I should. For the first two weeks, the dizziness was very strong. Now, at the three-week mark, it is more manageable and life is somewhat returning to normal. I visited an ENT doctor and their diagnosis was that my dizziness was not being caused by a preexisting medical condition. Their prediction was that I would be fine, though looking back, I downplayed the severity of my vertigo. At its worst, I felt that, when I went for a walk outside, the surface was the Earth was violently spinning through space, with me stuck to the surface. It felt paralyzing. My body felt almost stuck in shock. I was afraid I would be stuck with this dizziness for the rest of my life since it was so long-lasting. Now, I am taking ginger pills and am watching my sodium intake. I feel better but am extra vigilant about taking ginger and not stressing myself too much. I do not plan on getting a second shot since some of my symptoms mirror those of anaphylaxis.
21 2021-04-08 numbness, tingling Patient passed out roughly 5-10 minutes following vaccine while seated on a planter; witnessed by st... Read more
Patient passed out roughly 5-10 minutes following vaccine while seated on a planter; witnessed by store employee. Hit his head causing a small laceration above the right eyebrow which was cleaned with alcohol and bandaged prior to EMS arrival. The patient experienced dizziness and numbness/tingling in both hands/arms. He was able to tell RPh his name, the year, and knew where he was. Paramedics were called to assess his condition. Per patient and mother, only underlying condition is anxiety and only medication is zoloft.
21 2021-04-09 muscle spasms Severe nausea. Unable to keep down ANY liquids including water for the first 24 hours after the vacc... Read more
Severe nausea. Unable to keep down ANY liquids including water for the first 24 hours after the vaccine was administered. Uncontrollable sweating (no fever), muscle spams near vaccine site on left arm and in left shoulder blade. Headache.
21 2021-04-09 pain in extremity Sore arm, mild aches, and very mild headaches.
21 2021-04-09 tingling tunnel vision for a bit which then went away; felt like fainting; tinging in his toes and left arm a... Read more
tunnel vision for a bit which then went away; felt like fainting; tinging in his toes and left arm and fingers.; This spontaneous case was reported by a consumer and describes the occurrence of TUNNEL VISION (tunnel vision for a bit which then went away) in a 21-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 031A217) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below. The patient's past medical history included No adverse event (No reported medical history). On 02-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 02-Apr-2021, the patient experienced TUNNEL VISION (tunnel vision for a bit which then went away) (seriousness criterion medically significant), PRESYNCOPE (felt like fainting) and PARAESTHESIA (tinging in his toes and left arm and fingers.). At the time of the report, TUNNEL VISION (tunnel vision for a bit which then went away), PRESYNCOPE (felt like fainting) and PARAESTHESIA (tinging in his toes and left arm and fingers.) outcome was unknown. The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown. No concomitant medications were provided. Treatment information were not reported.; Sender's Comments: Based on the current available information and temporal association between the use of the product and the start date of these events, a causal relationship cannot be excluded.
21 2021-04-10 feeling cold Pt Fainted shortly after receiving vaccination. Pt came for a moderna covid vaccine with his friend,... Read more
Pt Fainted shortly after receiving vaccination. Pt came for a moderna covid vaccine with his friend, both first doses. Pt said he "fainted recently" from a shot where he fainted "for a couple minutes" according to his nurse, and he was sure it was psychologically induced by anxiety. He said he was more mentally prepared this time. After I gave the dose to him and his friend, he got lightheaded and slowly started losing consciousness in his seat after a few minutes. Pt was alert and responded to our questions. I quickly stepped out to give the pt a bottle of water, and upon coming back to the IMZ room, his friend said he urinated himself. He was less responsive, but still alert. I notified the technician. He started to turn pale and felt more cold. He pulse was weak. I encouraged the pt's friend to keep him alert while we call EMS. I reminded the pt to keep breathing. The technician called EMS, and I stayed with the patient to kept him calm, but alert until EMS arrived. Pt slowly felt better after a few minutes (color return, and temperature normalized). Pt said he was okay, and he was able to walk. EMS arrived and tested blood sugar; he was within normal range. Pt did not need EMS service, and went home with friend.
21 2021-04-11 weakness Weakness, chills, sweating, nausea, dizziness, headache, restlessness, pain around injection site, j... Read more
Weakness, chills, sweating, nausea, dizziness, headache, restlessness, pain around injection site, joint pain, lower back pain
21 2021-04-11 pain in extremity Arm swollen, reddened, warm and painful
21 2021-04-12 cold sweat Clammy, sweaty, low blood pressure of 92/45. Patient recovered to normal after about 20 minutes
21 2021-04-12 feeling hot The patient passed out after 10 minutes after feeling really hot and sweating. He became consciou... Read more
The patient passed out after 10 minutes after feeling really hot and sweating. He became conscious in less than a minute and was feeling okay.
21 2021-04-13 seizure Client passed out while seated in observation falling to the right side of the chair and onto the gr... Read more
Client passed out while seated in observation falling to the right side of the chair and onto the ground Client landed face down on the floor and was turned over onto his side first before being flipped onto his back Client?s head did hit the ground Client reportedly appeared to be having a seizure when he was turned over Multiple people were present to assist client including nurse and EMT At12:09, LVN called 911 and relayed information to the dispatch While on the phone, nurse went to get an Ambu-bag because staff present reported that the Client stopped breathing but had a pulse Upon bringing the Ambu-bag, the Client had already regained normal breathing pattern and no longer needed assistance breathing . Ambu-bag was present but was not used Client was assisted into a wheelchair and taken to the private recovery area. Physician, nurse, and EMT were present Client was alert enough to answer questions Client began to vomit / dry-heave for a short moment Client asked EMT about transport billing and was informed that he might possibly get a bill but that he had the option to choose not to pay it At 12:20, Vitals taken BP 155/112, Pulse 64 Client informed of the need to be further evaluated at the hospital Client verbalized multiple times that he did not want to be transported even after speaking with the physician Physician suspected that the client had some underlining reason that he did not want to disclose regarding his refusal to be transported At 12:25, Vitals taken BP 135/83, Pulse 58, O Sat 97% Blood sugar reading 104 Client reports no pain in the head, no nausea Client reports that he did not eat anything prior to coming At 12:31, Ambulance arrives EMT briefs paramedic regarding the incident and the client?s history Paramedics questioned client Client signed form and verbalized that he did not want to be transported and felt well enough to leave Client called his brother to drive him home At 12:41 Client was wheeled in the wheelchair to the car Client informed of selfcare and instructed to go to the hospital / ER if symptoms worsen or headaches develop Client informed to let further vaccine administrators know that he passed out in the past and needs to have the injection lying down Client verbalized understanding Client?s brother drove him home
21 2021-04-13 tremor Patient stayed in pharmacy area for 15 minute observation time. Was released from pharmacy in good c... Read more
Patient stayed in pharmacy area for 15 minute observation time. Was released from pharmacy in good condition and left to shop with parents and sister. Approximately 5 minutes later, sister came and said he was very dizzy and sitting in chair in store. Pharmacist checked BP 131/75 HR 97. Patient had not eaten breakfast, was dizzy and shaking. Parents had gotten him a sandwich and orange juice was added in case due to blood sugar drop. Parents stated he was not presenting as having a seizure. He began feeling nauseous and vomited 3 times while waiting for EMTs to arrive. EMTs checked him out, blood sugar 93. They took him to ER to be examined and was released to go home later same day. Per conversation with parent that evening, he was doing better after having several episodes of vomiting at hospital.
21 2021-04-14 weakness, pain in extremity 21yo male reports with adverse effects of 1st dose Moderna covid-19 vaccine. Endorses decreased en... Read more
21yo male reports with adverse effects of 1st dose Moderna covid-19 vaccine. Endorses decreased energy, sore arm, photophobia. VSS and WNL. Lungs CTAB. CV RRR no MGR. - reported in VAERS - tylenol 1000mg q8 hours - 24 hours quarters
21 2021-04-14 unresponsive to stimuli At the pre-counsel stage, the patient said that he was a little nervous about getting this immunizat... Read more
At the pre-counsel stage, the patient said that he was a little nervous about getting this immunization, but wanted to go ahead and do it. I counseled him on the immunization and sent him into the booth to get the shot. Technician administered the vaccine and then told Technician that he felt a little nauseous. Technician told him to stay seated. A few seconds later the patient passed out and started slipping down the chair. Technician grabbed him from behind and called me over to assist. I yelled for Staff to call 9-1-1 and a code white. I held him from the front and Technician held him from the back and we slowly lowered the patient to the floor. Technician sat behind the patient to hold him up while I assessed the patient and tried see if he was responsive. The patient was breathing and had a pulse, so I patted him on the face and chest to see if he would become responsive. After about 15 seconds, the patient became responsive and confused. He asked what happened and if he got the shot yet or not. After talking to the patient for a moment he said he was fine, but needed to vomit. I gave him a trash can and he vomited. We gave the patient some water and sat with him on the ground for a few minutes until the paramedics arrived. The paramedics took the patient's vitals and the patient said he felt fine and declined going to the hospital. We had the patient sit in the observation area for another 30 minutes. He said he felt totally fine and was ready to go home.
21 2021-04-15 feeling hot Patient presented to Health Center after receiving COVID-19 vaccine at Health Center, and going back... Read more
Patient presented to Health Center after receiving COVID-19 vaccine at Health Center, and going back to work site. He stated when he got to work, he began feeling hot, dizzy, nauseous, and pruritic. Vitals stable. He denied chest pain, difficulty breathing. Pt given IM Benadryl 12.5 mg in office and oral hydration w/ water. He was monitored for about 30 minutes, and said pruritus had resolved, but he felt tired. EMS called to transport pt to ED. Pt called by Health Center staff about 2 hours later to see how he was doing. He stated he was on his way home as he had been discharged from ED and told to monitor symptoms.
21 2021-04-15 hot flush Immediately following vaccination, patient described dizziness and "hot flash" and moved from chair ... Read more
Immediately following vaccination, patient described dizziness and "hot flash" and moved from chair to floor. Patient treated with ice pack and monitoring of vitals for additional time. Symptoms completely resolved and patient released from clinic at 7:00pm.
21 2021-04-15 unresponsive to stimuli Systemic: Dizziness / Lightheadness-Mild, Systemic: Fainting / Unresponsive-Mild, Additional Details... Read more
Systemic: Dizziness / Lightheadness-Mild, Systemic: Fainting / Unresponsive-Mild, Additional Details: Redo: Pt was waiting for 15 mins observation, he felt dizzy and fainted and fell to the ground and hit his head. Called ambulance, temp. was 97.2 bp 120/71. pt gained concious right away and stood up. I assisted pt to lay back to the ground and raised his leg to a chair. ambulance came, checked blood sugar was 80. took him to hospital.
21 2021-04-15 unresponsive to stimuli Systemic: Dizziness / Lightheadness-Mild, Systemic: Fainting / Unresponsive-Mild, Additional Details... Read more
Systemic: Dizziness / Lightheadness-Mild, Systemic: Fainting / Unresponsive-Mild, Additional Details: Patient received his moderna shot on april 15 at around 3:50pm, and was seated for observation for 15 minutes. Patient felt dizzy and fainted and fell to the ground and hit his head. I ran to him and he gained concious within few seconds and stood up. I helped him to lay back on the floor and raised his leg on a chair. At 4:02 Temprature was 97.2 & blood pressure 120/71. Patient was responding & mention he fainted also few days ago when he had blood drawn for some blood work. Ambulance took over
21 2021-04-16 migraine I woke on the 8th day after the shot with pain around the injection site, extra fatigue, and a migra... Read more
I woke on the 8th day after the shot with pain around the injection site, extra fatigue, and a migraine. These symptoms are currently ongoing
21 2021-04-17 unresponsive to stimuli Syncope: Patient became pale and was unable to answer questions roughly 2-3 minutes after receiving ... Read more
Syncope: Patient became pale and was unable to answer questions roughly 2-3 minutes after receiving the vaccination. Shortly thereafter, his head rolled back and he slumped in the chair for ~10 seconds before regaining consciousness. After awaking, he regained his senses rapidly and was able to state his name and the date. I requested he remain in the area for an additional 30 minutes for his safety. He agreed.
21 2021-04-19 tremor Patient was sitting in the waiting room alert and responsive after his vaccine. Suddenly while he wa... Read more
Patient was sitting in the waiting room alert and responsive after his vaccine. Suddenly while he was sitting in the waiting room His eyes began to roll back into his head, his head dropped and his body tensed up and he began to shake. The event lasted approximately 30 and then the patient became alert and oriented again. When he became alert again he seemed very sweaty and pale. Nurse Practitioner took blood pressure and it was 100/58. Paramedics arrived on scene approximately 5 minutes after and transported him to the hospital.
21 2021-04-21 weakness, feeling hot, seizure Patient received vaccine in left deltoid and immediately responded which looked like a short seizure... Read more
Patient received vaccine in left deltoid and immediately responded which looked like a short seizure, losing consciousness shortly, then upon shaking responded by waking back up. Within the next few minutes the patient did the exact same thing and again responded after shaking by waking back up. Patient felt hot, weak and nauseous for quite a long time, he eventually vomited and thought he felt a little better. We called EMS and they responded by checking him over (B.S. 79 and Blood Pressure initially 87/60 but a repeat reading was 105/74 and patient felt well enough to decline a trip to the hospital. Patient was still feeling weak, so we observed him for over 2 hours and he took some water and drank some gatorade. After a bit we had him call his mother to drive him home. Patient was standing when we had one of our interns take him to his mother's car.
21 2021-04-21 pain in extremity Fever, chills, nausea, headache, and arm soreness. Teeth chattering from chills.
21 2021-04-21 unresponsive to stimuli Systemic: Fainting / Unresponsive-Mild, Additional Details: During the 15 minute observation period ... Read more
Systemic: Fainting / Unresponsive-Mild, Additional Details: During the 15 minute observation period after recieving his vaccination, the patient fainted. Patient was conscious, given some water, and told to lay down for the rest of the observation period. No emergency responders required.
21 2021-04-22 burning sensation, numbness, weakness Dizziness and Extreme weakness (to the point walking was difficult) Numbness Burns Muscle pains Ment... Read more
Dizziness and Extreme weakness (to the point walking was difficult) Numbness Burns Muscle pains Mental foginess
21 2021-04-22 hypersensitivity of all senses Hyperesthesia affecting left side of the body from shoulder to ankle. Started a few hours after inje... Read more
Hyperesthesia affecting left side of the body from shoulder to ankle. Started a few hours after injection along with chills and malaise. The hyperesthesia has persisted along with headaches.
21 2021-04-22 unresponsive to stimuli Vaccine was administered at approximately 6:15PM and patient was instructed to sit in waiting room f... Read more
Vaccine was administered at approximately 6:15PM and patient was instructed to sit in waiting room for 10 to 15 minutes to make sure he was OK. He looked fine and sat looking at his phone for approximately 5 minutes. He then stood and walked to pick up window and asked if it was normal to have stomach pains. I said no and asked if he felt dizzy. He said "no" then turned to go back to his chair. As soon as he turned he said "now I feel dizzy". I told him to return to his chair and he suddenly crumbled to the floor. I had my technician call 911. After 1 to 2 seconds of being unresponsive he suddenly came to. I had him continue laying on floor for a couple minutes and then he got up on his own and went to the chair. We gave him a cool towel for his neck and had him lean his head forward and down onto a chair placed in front on him. The paramedics came within minutes and found him to be OK. After they left he continued sitting in the chair for approximately 10 more minutes while talking on the phone (to his parents, I think). He then left stating that he was now OK and that it probably happened because he was nervous
21 2021-04-24 flushing Systemic: Dizziness / Lightheadness-Severe, Systemic: PATIENT VOMITED WITH IN MINUTES AFTER SHOT AND... Read more
Systemic: Dizziness / Lightheadness-Severe, Systemic: PATIENT VOMITED WITH IN MINUTES AFTER SHOT AND HE BECAME DIZZY AND SWEATY.-Severe, Systemic: Flushed / Sweating-Severe
21 2021-04-25 tremor Numbness on the chest and shaking.
21 2021-04-27 feeling hot Vasovagal response. Several minutes after receiving this dose, the patient became very light headed ... Read more
Vasovagal response. Several minutes after receiving this dose, the patient became very light headed and dizzy. He got warm, sweaty, and pale. He said his vision went black for a minute or two. Once he laid down and put his feet up, he began feeling better. His vision was back to normal and he was no longer dizzy. After laying on the floor for several minutes, the patient sat up for another few minutes before going home. Paramedics were called by management. They checked his vitals during this time, but did not provide any treatement.
21 2021-04-27 pain in extremity Swollen under the arm pit. Lymph nodes from what I read. Fatigued and muscle soreness in right arm.
21 2021-04-27 tenderness 21 yo male had the Moderna vaccine 1.5 weeks ago and 3 days ago he was lifting light and last hs he ... Read more
21 yo male had the Moderna vaccine 1.5 weeks ago and 3 days ago he was lifting light and last hs he got pain and swelling to the left upper back above the scapula. He has 10/10 pain. he has been icing it. He did not lift heavy when working out and did not feel a pull or twinge. It was his first vaccine in the series. Physical exam: He has 4 cm area of tenderness and swelling to the left upper back, above the scapula. Pain with abduction of the left arm. No pain in shoulder joint or swelling.
21 2021-04-30 weakness On 4/29/21 around 9 PM, I started feeling chills, fever, severe headache, muscle aches all over my b... Read more
On 4/29/21 around 9 PM, I started feeling chills, fever, severe headache, muscle aches all over my body. I felt weak and tired throughout the night of the 29th. By morning most side effects subdued but still felt weak and tired.
21 2021-05-01 discomfort After the second shot (4/21/21) I had a common reaction, fever, aches and felt really unwell the day... Read more
After the second shot (4/21/21) I had a common reaction, fever, aches and felt really unwell the day after. The next day the only symptom I had remaining was lung/chest pain. The discomfort as not subsided any since the day after I got the shot (it had been over a week and a half), if any it has worsened slightly. It hurt most when I exhale and relax. It is a tight feeling in my mid chest.
21 2021-05-04 grand mal seizure, pain in extremity Grand mal seizure; "extreme sluggishness; "swollen eyes, they were basically swollen shut; dark and ... Read more
Grand mal seizure; "extreme sluggishness; "swollen eyes, they were basically swollen shut; dark and red coloration around his eyes/his eyes were red; difficulty breathing; sore arm; fatigue; he had a high fever just by touching him, he was extremely warm to the touch.; This spontaneous case was reported by an other caregiver (subsequently medically confirmed) and describes the occurrence of GENERALISED TONIC-CLONIC SEIZURE (Grand mal seizure) in a 21-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 002C21A and 020B21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below. Concurrent medical conditions included ADD. On 30-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 27-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 27-Apr-2021, the patient experienced SLUGGISHNESS ("extreme sluggishness), EYE SWELLING ("swollen eyes, they were basically swollen shut), OCULAR HYPERAEMIA (dark and red coloration around his eyes/his eyes were red), DYSPNOEA (difficulty breathing), PAIN IN EXTREMITY (sore arm), FATIGUE (fatigue) and PYREXIA (he had a high fever just by touching him, he was extremely warm to the touch.). On 28-Apr-2021, the patient experienced GENERALISED TONIC-CLONIC SEIZURE (Grand mal seizure) (seriousness criteria hospitalization, medically significant and intervention required). The patient was hospitalized from 28-Apr-2021 to 28-Apr-2021 due to GENERALISED TONIC-CLONIC SEIZURE. On 28-Apr-2021, GENERALISED TONIC-CLONIC SEIZURE (Grand mal seizure) had resolved. At the time of the report, SLUGGISHNESS ("extreme sluggishness), EYE SWELLING ("swollen eyes, they were basically swollen shut), OCULAR HYPERAEMIA (dark and red coloration around his eyes/his eyes were red), DYSPNOEA (difficulty breathing), PAIN IN EXTREMITY (sore arm), FATIGUE (fatigue) and PYREXIA (he had a high fever just by touching him, he was extremely warm to the touch.) had not resolved. DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, Blood test: (Inconclusive) No results were provided. On an unknown date, Chest X-ray: (Inconclusive) No results were provided. On an unknown date, Computerised tomogram: (Inconclusive) No results were provided. On an unknown date, Urine analysis normal: (Inconclusive) No results were provided. For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments. No concomitant medication were reported. Treatment included Advil for fever, Maxipime, Keppra for seizure prevention and normal saline. Action taken with mRNA-1273 in response to the event was Not Applicable Company Comment: Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded. This case was linked to US-MODERNATX, INC.-MOD-2021-098517, MODERNATX, INC.-MOD-2021-097451 (E2B Linked Report).; Sender's Comments: Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded. MODERNATX, INC.-MOD-2021-098517:Case for dose 1 MODERNATX, INC.-MOD-2021-097451:Cross linked case
21 2021-05-05 tingling On 5/5/21 patient developed an erythematous rash with large urticaria, warm to touch on his left upp... Read more
On 5/5/21 patient developed an erythematous rash with large urticaria, warm to touch on his left upper arm at the site of injection. He has been having intermittent paresthesia of his left upper/lower arm and hand.
21 2021-05-05 tremor Systemic: Dizziness / Lightheadness-Mild, Systemic: Shakiness-Mild.
21 2021-05-07 migraine Severe chills and nausea, diarrhea, exhaustion, fatigue, migraine
21 2021-05-07 seizure Systemic: Dizziness / Lightheadness-Medium, Systemic: Nausea-Medium, Systemic: Seizure-Medium
21 2021-05-07 unresponsive to stimuli Client stated he did not like needles and did almost pass out last time he got a vaccine. Client was... Read more
Client stated he did not like needles and did almost pass out last time he got a vaccine. Client was given moderna vaccine in left deltoid and was asked to stay seated, but the client said he felt fine, that it was a small needle so he was allowed to walk to the waiting area and went to get a snack also. About 5 min after this I was called to the client as he was being lowered to the ground by his sister and MA with department. The client was unresponsive for about a min. We raised his legs and he regained consciousness soon after, and was able to open his eyes and talk. About 3 min later client sat up on the ground, no other injuries per the client. A few minutes later he got himself up and sat on the bench. Still a little pale and diaphoretic. About 30 min after receiving vaccine he felt much better and said he was ok to leave and go back to work.
21 2021-05-08 pain in extremity Pain in left arm approximately 3 hours after injection. Chills began the night of getting vaccine.... Read more
Pain in left arm approximately 3 hours after injection. Chills began the night of getting vaccine. Fever set on shortly after and lasted until approximately 7pm the next day. Headache set in approximately midnight and continued to varying severity until Sunday (2 days after injection) morning around 10 am.
21 2021-05-09 pain in extremity Sore arm, lightheaded, dizziness
21 2021-05-10 seizure Right after administering the immunization the patients head rolled back and his body started to con... Read more
Right after administering the immunization the patients head rolled back and his body started to convulse. Put him onto the floor he stopped convulsing and went limp. As I was checking for a pulse he woke back up very disoriented. EMS was called they came and took him to the hospital
21 2021-05-12 weakness I woke up at 9 am with a splitting headache, tried to stand up and I was dizzy and more sore than I ... Read more
I woke up at 9 am with a splitting headache, tried to stand up and I was dizzy and more sore than I had ever been across my whole body. It was incredibly hard to walk also, but I would contribute alot of that to the adductor exercise I had done the previous day. I was also drained of enegery and just wanted to sleep though no position was comfortable. I had an appetite and was able to eat and take some acetaminophen. This along with rest, alot of water and patience seemed to work. The side effects from the vaccine were gone by the next morning.
21 2021-05-12 grand mal seizure Patient received his Moderna vaccine and immediately (10-15 seconds) appeared to be seizing. His mu... Read more
Patient received his Moderna vaccine and immediately (10-15 seconds) appeared to be seizing. His muscles were tensed, tonic clonic, he was pale, hot to the touch, and excessively sweating. However, the fire department reported it as a syncopal episode. The fire department paramedics came and monitored him until his family came to pick him up. His pulse was 57, blood pressure was 102/54, respirations 20, glucose 116, pulse of 96. Patient denied treatment to the hospital and requested to go with his parents. His dad is a physician.
21 2021-05-12 unresponsive to stimuli, flushing Systemic: Dizziness / Lightheadness-Medium, Systemic: Fainting / Unresponsive-Medium, Systemic: Flus... Read more
Systemic: Dizziness / Lightheadness-Medium, Systemic: Fainting / Unresponsive-Medium, Systemic: Flushed / Sweating-Medium
21 2021-05-13 flushing Systemic: Dizziness / Lightheadness-Medium, Systemic: Flushed / Sweating-Medium, Systemic: Nausea-Se... Read more
Systemic: Dizziness / Lightheadness-Medium, Systemic: Flushed / Sweating-Medium, Systemic: Nausea-Severe, Systemic: Vomiting-Severe, Additional Details: about 10 minutes after receiving the vaccine the patient started sweating and vomiting
21 2021-05-13 pain in extremity Mildly sore arm, onset within an hour of injection Fatigue, onset around 4 p.m. Insomnia, first noti... Read more
Mildly sore arm, onset within an hour of injection Fatigue, onset around 4 p.m. Insomnia, first noticed when trying to sleep at 8:30 Nausea, onset around midnight which gradually worsened but has since become mild Chills, onset around midnight Mild chest tightness, onset around 2 a.m. Headache, onset around 3 a.m. which gradually worsened
21 2021-05-14 flushing Systemic: Dizziness / Lightheadness-Mild, Systemic: Fainting / Unresponsive-Mild, Systemic: Flushed ... Read more
Systemic: Dizziness / Lightheadness-Mild, Systemic: Fainting / Unresponsive-Mild, Systemic: Flushed / Sweating-Mild, Additional Details: patient felt lightheaded and was with girlfriend who then sat down in the chair and passed out for a few seconds maybe 10-20 seconds then came to ems was on the way, gave water to the patient and the told me he had nothing to eat all day asked if a banana was ok to give hime he said yes. ems came and took vitals. after 15minutes of monitoring he waive additional treratment and left on his own
21 2021-05-14 tremor, seizure convulsions, woke up at night with severe uncontrollable shaking. Teeth were chattering with each ot... Read more
convulsions, woke up at night with severe uncontrollable shaking. Teeth were chattering with each other. Also next morning had 101.5 F fever
21 2021-05-16 cold sweat PATIENT FELT LIGHT HEADED. MOTHER WAS PRESENT WITH HIM. SHE CAME UP TO THE COUNTER TO LET US KNOW BU... Read more
PATIENT FELT LIGHT HEADED. MOTHER WAS PRESENT WITH HIM. SHE CAME UP TO THE COUNTER TO LET US KNOW BUT THEN HE IMMEDIATELY FAINTED AND FELL TO THE GROUND FROM HIS CHAIR. 911 WAS IMMEDIATELY CALLED. PATIENT GAINED CONSCIOUSNESS WITHIN NO MORE THAN 1 MINUTES. HE WAS AWARE, ALERT, AND ORIENTED (PATIENT CONFIRMED HE DID HAVE BREAKFAST THAT MORNING). HE WAS CLAMMY AND SWEATY. HE EXPLAINED THAT HE USUALLY EXPERIENCES THIS TYPE OF FAINTING EVENT WITH NEEDLES. PARAMEDICS ARRIVED ON THE SCENE AND EVALUATED PATIENT'S CONDITION. PATIENT'S BP AND EKG WERE WNL. PATIENT REFUSED BLOOD SUGAR TEST D/T NEEDLE PHOBIA (HE SAID HE DID NOT WANT TO PASS OUT AGAIN), AND HE DECLINED GOING TO THE ER.
21 2021-05-16 seizure Patient appeared to have a seizure within 3 minutes of receiving the vaccine. He reported that this ... Read more
Patient appeared to have a seizure within 3 minutes of receiving the vaccine. He reported that this has never happened before. He refused EMT treatment and we followed up with him 2 days later. His mother confirmed that he had no additional symptoms.
21 2021-05-18 concussion Patient experienced a near syncopal episode within 5 minutes of receiving the vaccine. He was seated... Read more
Patient experienced a near syncopal episode within 5 minutes of receiving the vaccine. He was seated in table in the back of the room of the Observation area. He had been put there as during his first COVID vaccine on 4/21/2021 he fainted and went to the ER. He has been suffering from mild concussion symptoms since 4/21 such as headaches and fatigue. His vitals at 9:15 were BP 138/88, HR 102, O2 Sat 97%. ARNP assisted pt. with an ice pack to his forehead and assessed mental status. He was alert and oriented x 3, no neck pain, pale, no disturbed vision, able to move hands and legs. He had eaten ~8 oz of yogurt and a peach at 8:45 just prior to the vaccine at 9:10. While with us he drank 6 oz of apple juice followed by vitals of 125/76 and pulse of 74 along with O2 Sat of 99% Student is a graduated senior at the University where he received both vaccines. He is originally from out of town and will return there in 6 days. He remained with us for 40 minutes. He was released to walk home with a friend (~ 3 blocks) and rest for the remainder of the day. Spoke with pt. 3 hours later and no s/s, no negative reaction-feels well
21 2021-05-18 muscle twitching Site: Pain at Injection Site-Mild, Systemic: muscle twitches random, last about 20 seconds. started ... Read more
Site: Pain at Injection Site-Mild, Systemic: muscle twitches random, last about 20 seconds. started in arm,moved to other arm, also in neck.-Medium, Systemic: Headache-Mild, Systemic: Nausea-Mild, Additional Details: Patient reports experiencing mild headache and nausea, then a couple days after injection started experiencing muscle twitches started in right arm, then left arm, and today started in neck area. Twitches are random and last about 20 sec. Patient was counseled on hydration and to follow up with medical evaluation if symptoms persisted continued to move to other locations.
21 2021-05-18 seizure Patient is 21 y/o male presenting to pharmacy for COVID vaccination, received vaccine at 1500, short... Read more
Patient is 21 y/o male presenting to pharmacy for COVID vaccination, received vaccine at 1500, shortly after administration of vaccine (roughly 1503), patient experienced brief tonic/clonic seizure, total time of seizure less than 20 seconds, seizure resolved spontaneously. EMT's were dispatched to location, ER visit/hospitalization deemed unnecessary. Patient stayed at the pharmacy for the remainder of the 30 minute observation period with no significant events. Patient and parents mentioned history of seizure after vaccination, though specific product could not be recalled. Patient has no formal diagnosis of seizure disorder, which was confirmed by medical testing completed in childhood, and has no history of antiepileptic medication.
21 2021-05-18 seizure patient fainted and started convulsing - ambulance was called
21 2021-05-19 tremor Course Rapid Tremors in Left Arm Only when Clenching Fist
21 2021-05-21 weakness Pain and tenderness at injection sight almost imediately. Muscle pain within first hour. Dizziness,... Read more
Pain and tenderness at injection sight almost imediately. Muscle pain within first hour. Dizziness, weakness, loss of consciousness, nausea, and vomiting approximately 10 hours after injection.
21 2021-05-21 unresponsive to stimuli, muscle twitching Patient was given vaccine. He did not state he was scared of needles. i asked him to have seat outsi... Read more
Patient was given vaccine. He did not state he was scared of needles. i asked him to have seat outside pharmacy for 15 minutes to observe him. His friend with him said he passed out in the chair sitting down.We called 911 and I went to assess him and spoke to him and touched him with no response. He proceeded to slide out of chair and I brought him to the floor and laid his to the side. He twitched and eyes fluttered. I then injected him with epi-pen thinking he may have been having an allergic response. His skin was white. After injection his coloring came back and slowly started to speak.He was able to form sentences. Police and EMS came and assessed him within 10 minutes and took his blood pressure. He was coherent and coloring resumed on patients face. Patient stated he had a little of tingling and mentioned he passes out occasionally after giving blood. Patient was released and aunt came to store and did not seek any further medical attention even though ems wanted him to get checked out. Blood pressure continued to rise and EMS believes patient had vasophagal syncope.
21 2021-05-23 pain in extremity Arm soreness 3 hours after, Fever and sore throat next day
21 2021-05-23 seizure Very high fever, 108, leading to passing out, convulsion then vomiting
21 2021-05-25 pain in extremity This is a 21 year old male who had his first dose Moderna vaccine on 3/18/21 (lot#001B21A) and secon... Read more
This is a 21 year old male who had his first dose Moderna vaccine on 3/18/21 (lot#001B21A) and second dose on 5/9/21 (lot#024C21A). On 5/13/21, the patient presented to the emergency department with complaints of shortness of breath, chest pain, 'sharp shooting pain going up my leg/thigh,' pain 5/10, and nausea. Onset on 5/12/21. The patient has a history of a recent ED admission on 4/24/21 for abdominal pain, felt to be related to a recent diagnosis of hepatic stenosis, biliary sludge (unrelated to the 5/9/21 ED visit, however notable; discharged to home to f/u with established surgeon). The patient stated that this may be related to chronic anxiety. ED provider determined that acute chest pain was likely due to anxiety and/or a vaccine reaction. The patient was discharged to home with instructions to f/u if needed. No additional chart documentation available since discharge.
21 2021-05-31 seizure, feeling hot The patient was administered the first dose of the Moderna COVID-19 vaccine. Immediately after the i... Read more
The patient was administered the first dose of the Moderna COVID-19 vaccine. Immediately after the injection, the patient lost consciousness in his seat and slumped over. He was caught by the pharmacist, then briefly seized before regaining consciousness. Upon regaining consciousness, the patient complained of feeling hot and dizzy. Emergency medical services were called and they arrived within 5 minutes. In that time, the patient appeared to have mostly recovered and was comfortable leaving after being cleared by EMS. The patient was referred to their physician for guidance regarding the second dose of the vaccine.
21 2021-06-03 unresponsive to stimuli Systemic: Fainting / Unresponsive-Medium, Additional Details: patient passed out from chair about 5 ... Read more
Systemic: Fainting / Unresponsive-Medium, Additional Details: patient passed out from chair about 5 minutes after dose given. I was helping an intern get her 1-9 information into the ipad. There was another vaccine patient waiting in a chair, she immediately came and got me, I rushed to the patient to bring him back to consciousness. I shock his shoulders and he started to come back. Staff team members were extremely helpful. They came right away with water and help to assist with anything the patient needed. Patient stated that he felt hungry.
21 2021-06-11 seizure PT DID FINE IMMEDIATELY, ATER VACCINE WITHIN A FEW MINUTES HE PASSED OUT, FELL OUT OF HIS CHAIR AND ... Read more
PT DID FINE IMMEDIATELY, ATER VACCINE WITHIN A FEW MINUTES HE PASSED OUT, FELL OUT OF HIS CHAIR AND STARTED SEIZING. I RUSHED OUT OF THE PHARMACY PUT A SOFT PAD UNDER HIS HEAD AND PREVENTED HIM FROM HITTING IT ON THE FLOOR. I TOLD A CUSTOMER TO CALL 911, SHOTRLY AFTER PATIENT WOKE UP AND ASKED US TO CALL HIS PARENTS. ANOTHER CUSTOMER DID THAT AND THEN THE EMS ARRIVED. THEY CHECKED ALL HIS VITALS WHICH WERE WITHIN NORMAL LIMITS AND HE CHOSE TO NOT GO WITH THEM. HIS SISTER PICKED HIM UP TO GO HOME. PT STATED HE HAD NOT EATEN THAT DAY AND HAD TAKEN IBUPROFEN BEFORE ARRIVING.
21 2021-06-15 flushing Systemic: Fainting / Unresponsive-Medium, Systemic: Flushed / Sweating-Mild, Additional Details: Pat... Read more
Systemic: Fainting / Unresponsive-Medium, Systemic: Flushed / Sweating-Mild, Additional Details: Patient reports that they did not eat or drink anything all day prior to receiving vaccination in the early afternoon. Suspect that dehydration or low blood sugars may have contributed to syncope event. Patient become unresponsive for about 60 seconds with pulse. Patient had returned to stable vitals within 10 minutes of event.
21 2021-06-22 tremor, tingling, unresponsive to stimuli Site: Pain at Injection Site-Mild, Systemic: Fainting / Unresponsive-Mild, Systemic: Shakiness-Mild,... Read more
Site: Pain at Injection Site-Mild, Systemic: Fainting / Unresponsive-Mild, Systemic: Shakiness-Mild, Systemic: Tingling (specify: facial area, extemities)-Mild
21 2021-06-23 discomfort My left testicle began to have random shooting pains that were slightly uncomfortable and after a fe... Read more
My left testicle began to have random shooting pains that were slightly uncomfortable and after a few weeks of that pain progressively getting much worse and the shooting pains happening more frequently one night my entire scrotum (including my right testicle) began to hurt so bad and for such long periods I went to the emergency room. I had an ultrasound done as well as tests for STDs and STIs and had no structural damage in my testicles nor any sexually transmitted problems. It has gotten somewhat better but there is still some general discomfort in my scrotum. While it was at its worse my scrotum was somewhat swollen (which it still is slightly), very red, and looked as if there were numerous blood clots on the surface of my scrotum.
21 2021-06-23 pain in extremity pt received #1 Moderna vaccine yesterday, pain on left arm, shoulder started around 3 pm, c/o dizzin... Read more
pt received #1 Moderna vaccine yesterday, pain on left arm, shoulder started around 3 pm, c/o dizziness and nausea*1, denies any blood in the emesis, denies any traumatic injury, last OTC Tyrenol 2 tabs taken at 2200 last night without any relief,
21 2021-06-23 seizure like phenomena AFTER GETTING HIS 1ST DOSE OF MODERNA VACCINE, PATIENT SAT IN THE OBSERVING AREA. AND WITHIN 2 MINUT... Read more
AFTER GETTING HIS 1ST DOSE OF MODERNA VACCINE, PATIENT SAT IN THE OBSERVING AREA. AND WITHIN 2 MINUTES OF RECEIVING THE VACCINE, PATIENT HAD A SEIZURE LIKE SYMPTOMS FOR 1-2 SECONDS AND HE FELL OFF THE CHAIR. HIS MOTHER WAS THERE TO CATCH HIM. I CAME RUNNING OUT TO ASSIST. HE REGAINED CONSCIOUSNESS ALMOST IMMEDIATELY AND REMEMBERED EVERYTHING THAT HAPPENED. BUT HE TOLD ME THAT HE FELT VERY DIZZY. I HAD HIM LAY DOWN ON HIS SIDE. HE WAS ALSO SWEATY. HE LAY ON THE FLOOR FOR THE NEXT 10 MINUTES, DURING THAT WHOLE TIME HE WAS ALERT AND AWAKE. ONCE HE FELT BETTER AFTER 10 MINUTES LATER, HIS MOTHER TOOK HIM HOME. WE DIDNOT HAVE TO CALL AN AMBULANCE FOR HIM.
21 2021-06-24 pain in extremity Chest pains (tension and pressure), nausea, loss of appetite, fatigue, shart left arm pain non muscu... Read more
Chest pains (tension and pressure), nausea, loss of appetite, fatigue, shart left arm pain non muscular lasting for weeks.
21 2021-06-25 cold sweat Pericarditis. Strong chest pain cold sweats
21 2021-06-25 flushing, numbness About an hour after getting the shot, the skin on my right arm was flushing before going numb. Then ... Read more
About an hour after getting the shot, the skin on my right arm was flushing before going numb. Then my shoulder went partially numb and it's still numb/frozen as of 2:20 am 26/June/2021. Over the course of nine hours from when I got the shot, starting at around 1 hour after, I started to get symptoms, which as of right now are still here. After my skin started acting up, my blood pressure dropped and my heart was pounding extremely hard in my chest and felt tight. My muscles have been going between losing muscle tone and being locked up extremely hard. I've been dizzy since about 3:00 pm 25/June/21, and it has progressively gotten worse to where I feel like I am going to pass out if I stand up. I have chills that make my chest tighten up and cause angina. I have been feeling very faint since around 9:00pm. I've had a mild headache since around 2:30pm, and have been feeling like I am falling since about 1am. Breathing takes manual effort. I have been feeling dissociated and nauseous since about 6pm and cannot remember much from after 6pm. I am not sure whether it is a medical emergency or not but I can't afford to go to the er.
21 2021-06-29 pain in extremity developed heart pain down both arms; myocarditis, every time his heart beat it hurt and he felt pres... Read more
developed heart pain down both arms; myocarditis, every time his heart beat it hurt and he felt pressure; This spontaneous case was reported by a consumer and describes the occurrence of MYOCARDITIS (myocarditis, every time his heart beat it hurt and he felt pressure) and PAIN IN EXTREMITY (developed heart pain down both arms) in a 21-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. No Medical History information was reported. On 22-May-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 24-May-2021, the patient experienced MYOCARDITIS (myocarditis, every time his heart beat it hurt and he felt pressure) (seriousness criteria hospitalization and medically significant). On an unknown date, the patient experienced PAIN IN EXTREMITY (developed heart pain down both arms) (seriousness criterion hospitalization). The patient was hospitalized for 3 days due to MYOCARDITIS and PAIN IN EXTREMITY. At the time of the report, MYOCARDITIS (myocarditis, every time his heart beat it hurt and he felt pressure) and PAIN IN EXTREMITY (developed heart pain down both arms) outcome was unknown. DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): In 2021, Blood test: high (High) high protein numbers. In 2021, Electrocardiogram: abnormal (abnormal) diagnosis of myocarditis. In 2021, Scan: abnormal (abnormal) diagnosis of myocarditis. For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown Route), the reporter did not provide any causality assessments. No treatment information was not given. No concomitant medication information was provided. The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was not applicable. Very limited information has been provided at this time. Further information has been requested. Reporter did not allow further contact; Sender's Comments: Very limited information has been provided at this time. Further information has been requested.
21 2021-07-05 unresponsive to stimuli Systemic: Dizziness / Lightheadness-Severe, Systemic: Fainting / Unresponsive-Medium, Systemic: Hypo... Read more
Systemic: Dizziness / Lightheadness-Severe, Systemic: Fainting / Unresponsive-Medium, Systemic: Hypotension-Medium
21 2021-07-06 pain in extremity Massive headache and joint pain mostly in back and legs.
21 2021-07-06 tremor Day of vaccination, patient experienced uncontrollable tremors in both arms. In response, patient to... Read more
Day of vaccination, patient experienced uncontrollable tremors in both arms. In response, patient took a dose of ibuprofen, performed stretches and took a nap; symptoms subsided. On June 28th, 2021, patient experienced another bout of tremors in both extremities at around 10am, which persisted for approximately 12 hours. After a televisit with CRNP, patient was referred to Emergency room. Patent reported to Hospital with continuing tremors. Doctors examined the patient's blood, as they head suspected rhabdomyolysis after ruling out any neurological causes for the symptoms. All bloodwork came back negative. Doctors intravenously injected 1.5 liters of saline fluid, after which the tremors subsided. Patient was thus discharged from ER. On July 2, 2021, at around 6pm, patient experienced sporadic tremors in right arm, which subsided after approximately 30 minutes. On July 4th, 2021, patient experienced frequent and sporadic tremors in both arms during the course of the day. Symptoms only subsided with sleep. On July 5th, 2021, patient experienced tremors in all four extremities during the course of the day. Consumed electrolyte water, remembering that the saline IV fluids had previously treated the tremors. Frequency and intensity of tremors decreased after patient consumed 48 fl oz of electrolyte water. Tremors fully subsided in sleep. On July 7th, 2021, patient was admitted to Family Practice and referred for a CT scan while still experiencing tremors. Scan showed no hemorrhages or growths in brain. Patient continues to experience sporadic and frequent tremors in all four extremities, varying in length and intensity.
21 2021-07-13 weakness sharp pain in left chest when breathing in and moving pressure in right chest low energy in whole bo... Read more
sharp pain in left chest when breathing in and moving pressure in right chest low energy in whole body feeling of being overwhelmed shortness of breath pain under ribs and stomach that comes and goes hearing sounds in ear when swallowing
21 2021-07-13 seizure PATIENT HAD SYNCOPY 15 MINUTES AFTER RECEIVING VACCINE. THERE WAS A FEW SECONDS OF CONVULSION BUT PA... Read more
PATIENT HAD SYNCOPY 15 MINUTES AFTER RECEIVING VACCINE. THERE WAS A FEW SECONDS OF CONVULSION BUT PATIENT regained consciousness right after, breathing was normal. patient was alert and not disoriented. no medical treatments were given.
21 2021-07-15 feeling hot, flushing PATIENT FELT WARM AND WAS FLUSH-MENTIONED PAIN BEGINNING IN THROAT
21 2021-07-15 hot flush Headache, muscle weakness (in entire body), muscle pain in shoulders and neck, chills, hot flashes. ... Read more
Headache, muscle weakness (in entire body), muscle pain in shoulders and neck, chills, hot flashes. Treated with 400mg of Ibuprofen.
21 2021-07-21 tremor The patient will now be using a wheelchair because when the tremors are in his legs the patient cann... Read more
The patient will now be using a wheelchair because when the tremors are in his legs the patient cannot walk.; continuing to experience tremors in all 4 extremities,; Tremors, only on the right arm; Tremors, only on the right arm; Tremors again in both arms; Patient started to experienced tremors, first on the left arm, and then on the right arm; This spontaneous case was reported by a consumer and describes the occurrence of GAIT DISTURBANCE (The patient will now be using a wheelchair because when the tremors are in his legs the patient cannot walk.) and TREMOR (continuing to experience tremors in all 4 extremities,) in a 21-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 051C21A and 050C21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below. Concurrent medical conditions included Allergy NOS. Concomitant products included DIPHENHYDRAMINE HYDROCHLORIDE (BENADRYL [DIPHENHYDRAMINE HYDROCHLORIDE]) for Allergy NOS, MONTELUKAST SODIUM (SINGULAIR), SALBUTAMOL (VENTOLIN [SALBUTAMOL]), FLUTICASONE PROPIONATE (FLOVENT) and MONTELUKAST for an unknown indication. On 26-May-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 23-Jun-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 23-Jun-2021, after starting mRNA-1273 (Moderna COVID-19 Vaccine), the patient experienced TREMOR (Patient started to experienced tremors, first on the left arm, and then on the right arm). On 28-Jun-2021, the patient experienced TREMOR (Tremors again in both arms). On 02-Jul-2021, the patient experienced the first episode of TREMOR (Tremors, only on the right arm). On 04-Jul-2021, the patient experienced the second episode of TREMOR (Tremors, only on the right arm). On 05-Jul-2021, the patient experienced TREMOR (continuing to experience tremors in all 4 extremities,) (seriousness criterion disability). On an unknown date, the patient experienced GAIT DISTURBANCE (The patient will now be using a wheelchair because when the tremors are in his legs the patient cannot walk.) (seriousness criterion disability). The patient was treated with SALINE [SODIUM CHLORIDE] (intravenous) on 28-Jun-2021 at a dose of 1.5 liter and IBUPROFEN (MOTRIN [IBUPROFEN]) at an unspecified dose and frequency. On 23-Jun-2021, TREMOR (Patient started to experienced tremors, first on the left arm, and then on the right arm) had resolved. On 28-Jun-2021, TREMOR (Tremors again in both arms) had resolved. On 04-Jul-2021, last episode of TREMOR (Tremors, only on the right arm) had resolved. At the time of the report, GAIT DISTURBANCE (The patient will now be using a wheelchair because when the tremors are in his legs the patient cannot walk.) and TREMOR (continuing to experience tremors in all 4 extremities,) outcome was unknown. DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 28-Jun-2021, Blood test: normal (normal) blood work came back normal.. For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments. ER doctors thought patient may have been dehydrated, and ruled out Rhabdomyolysis with the blood work. The patient went to see Neurologist on 13-Jul-2021.The patient was given a muscle relaxant that did not produce a beneficial result and underwent lab work, a basic neurological evaluation, and a CT scan. Company comment: 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. However, gait disturbance experienced by the patient is serious (disability) as tremors was not pre-existing prior to vaccine and gradually it worsened to an extent that he was unable to walk and was using wheel chair. Results of all diagnostics and current status is required for further assessment. This case was linked to MOD-2021-246753 (Patient Link). Most recent FOLLOW-UP information incorporated above includes: On 16-Jul-2021: Follow-up received on 16-Jul-2021 contains significant information: New event walking difficulty added, seriousness criteria medically significant added.; Sender'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. However, gait disturbance experienced by the patient is serious (disability) as tremors was not pre-existing prior to vaccine and gradually it worsened to an extent that he was unable to walk and was using wheel chair. Results of all diagnostics and current status is required for further assessment.
21 2021-07-22 bell's palsy, facial paralysis Full Blown up/Droopy eyes; Bell's Palsy; Droopy Mouth; This spontaneous case was reported by a nurse... Read more
Full Blown up/Droopy eyes; Bell's Palsy; Droopy Mouth; This spontaneous case was reported by a nurse and describes the occurrence of BELL'S PALSY (Bell's Palsy) and FACIAL PARALYSIS (Droopy Mouth) in a 21-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below. No Medical History information was reported. In June 2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. In June 2021, received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 18-Jul-2021, the patient experienced BELL'S PALSY (Bell's Palsy) (seriousness criterion medically significant) and FACIAL PARALYSIS (Droopy Mouth) (seriousness criterion medically significant). On 19-Jul-2021, the patient experienced EYELID PTOSIS (Full Blown up/Droopy eyes). The patient was treated with ACYCLOVIR [ACICLOVIR] for Bell's palsy, at an unspecified dose and frequency and PREDNISONE for Bell's palsy, at an unspecified dose and frequency. At the time of the report, BELL'S PALSY (Bell's Palsy), FACIAL PARALYSIS (Droopy Mouth) and EYELID PTOSIS (Full Blown up/Droopy eyes) outcome was unknown. For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments. No concomitant medications were reported. The patient received both vaccination doses in June (beginning and end of June). Company Comment: Very limited information regarding the dates of vaccine administration and the start date of the events have been provided. Further information has been requested.; Sender's Comments: Very limited information regarding the dates of vaccine administration and the start date of the events have been provided. Further information has been requested.
21 2021-07-27 weakness Myopercardis; heavy tightness in chest; maybe difficulty breathing; weak; chest pain; tired; This sp... Read more
Myopercardis; heavy tightness in chest; maybe difficulty breathing; weak; chest pain; tired; This spontaneous case was reported by a consumer and describes the occurrence of PERICARDITIS (Myopercardis) in a 21-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below. No Medical History information was reported. On 22-May-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 23-May-2021, the patient experienced CHEST DISCOMFORT (heavy tightness in chest), DYSPNOEA (maybe difficulty breathing), ASTHENIA (weak), CHEST PAIN (chest pain) and FATIGUE (tired). On an unknown date, the patient experienced PERICARDITIS (Myopercardis) (seriousness criterion medically significant). At the time of the report, PERICARDITIS (Myopercardis), CHEST DISCOMFORT (heavy tightness in chest), DYSPNOEA (maybe difficulty breathing), ASTHENIA (weak), CHEST PAIN (chest pain) and FATIGUE (tired) outcome was unknown. DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 24-May-2021, Electrocardiogram: inconclusive (abnormal) inconclusive. No treatment information was reported. No concomitant medications were reported. On 24 May 2021, the reporter stated the patient's father noticed the patient had chest tightness and maybe a difficulty breathing, was weak and tired. The patient's father took the patient to the hospital. The patient was diagnosed with myopericarditis and was being followed by a cardiologist. Company Comment: This is a 21-year-old male patient with pericarditis and myocarditis among other events after receiving mRNA-1273. 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. Most recent FOLLOW-UP information incorporated above includes: On 24-Jul-2021: Follow-up information received on 26-JUL-2021 contains significant information new event Myopercardis is updated.; Sender's Comments: This is a 21-year-old male patient with pericarditis among other events after receiving mRNA-1273. Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded.
21 2021-07-28 seizure Patient blacked out while sitting during the observation time. He hit his head in the fall and was o... Read more
Patient blacked out while sitting during the observation time. He hit his head in the fall and was observed having some convulsions.
22 2021-01-01 grand mal seizure Pt had grand mal seizure approximately 10 minutes post vaccination. Seizure lasted about 3 minutes, ... Read more
Pt had grand mal seizure approximately 10 minutes post vaccination. Seizure lasted about 3 minutes, then another seizure resulted approximately 2 minutes later lasting about 3 minutes, then ambulance arrived. Pts blood sugar was checked and was slightly low as well according to EMS. Pt seemed to stabilize. as being brought away, but in post-ictal phase.
22 2021-01-01 numbness, tingling Left side of body, extremities are feeling numb and tingly.
22 2021-01-06 discomfort I have had heavy lungs since the day after receiving the vaccine. It is hard to breathe, and hard to... Read more
I have had heavy lungs since the day after receiving the vaccine. It is hard to breathe, and hard to get a full breath. Their is slight discomfort when I inhale.
22 2021-01-09 weakness 01/4: Moderna Vax?developed headache shortly after injection 01/5: congestion, chills, weakness, bod... Read more
01/4: Moderna Vax?developed headache shortly after injection 01/5: congestion, chills, weakness, body aches He?s taking over the counter meds for now.
22 2021-01-10 throat numbness He reports that the same evening of the vaccine he noticed arm swelling, pain at the site and genera... Read more
He reports that the same evening of the vaccine he noticed arm swelling, pain at the site and generalized body aches. He also reports that his tongue and throat felt numb for four hours. He also noticed a little cough, shortness of breath and a runny/stuffy nose.
22 2021-01-13 cold sweat 5 minutes after vaccine patient complained of dizziness and became diaphoretic, pale, and clammy. BP... Read more
5 minutes after vaccine patient complained of dizziness and became diaphoretic, pale, and clammy. BP 74/48, HR 42 bpm, O2 92%. Water and snacks were given. At 10 minutes post vaccine HR was 52 bpm and O2 was 96%, patient is alert. At 15 minutes post vaccine BP was 90/50, O2 99%, HR 86 bpm and very talkative, states he is feeling better.
22 2021-01-28 tremor, numbness, tingling Received 2nd dose of Vaccine and developed numbness in his feet with tingling and shaking of his kne... Read more
Received 2nd dose of Vaccine and developed numbness in his feet with tingling and shaking of his knees. Admitted for observation (initial concern for Guillain-Barre). Patient slept all night and discarged the following day with no symptoms.
22 2021-02-01 seizure Low count platelets; Convulsions after vaccination without lose of consciousness; A spontaneous repo... Read more
Low count platelets; Convulsions after vaccination without lose of consciousness; A spontaneous report was received from a pharmacist concerning a 22-year-old male patient who received Moderna's COVID-19 Vaccine (mRNA-1273) and experienced convulsions without loss of consciousness and low platelet count. The patient's medical history was not reported. Concomitant medications were not provided. On 28 Dec 2020, the patient received their first of two planned doses of mRNA-1273 for the prophylaxis of COVID-19 infection. On 28 Dec 2020, after getting vaccinated, the patient immediately started to experience tremors and shaking all over his body which was described as convulsions without losing consciousness. On 05 Jan 2021, the patient had a blood test that showed a low platelet count. No treatment information was provided. Action taken for the event was not reported. The outcome of the events, convulsions without loss of consciousness and low platelet count, was considered unknown.; Reporter's Comments: This case concerns a 22-year old male patient. The medical history is not provided. The patient experienced a medically significant and unexpected medically significant event of Convulsions without losing consciousness immediately after receiving their first of two planned doses of mRNA-1273 (Lot unknown). Additionally, the patient experienced an unexpected non-serious event of Platelet count decreased. Based on the current available information and temporal association between the use of the product and the onset of the events, a causal relationship cannot be excluded and the events are considered possibly related to the vaccine.
22 2021-02-03 pain in extremity Body aches (lower back and legs mostly), Sore arm, fatigue all for a little over a day the day afte... Read more
Body aches (lower back and legs mostly), Sore arm, fatigue all for a little over a day the day after the second dose
22 2021-02-05 hot flush Nausea, light headed, hot flashes, oxygen level decrease, blood pressure decrease, heart rate decrea... Read more
Nausea, light headed, hot flashes, oxygen level decrease, blood pressure decrease, heart rate decrease, temperature decrease. All in cycles of 10 minutes on, a few minutes off. Was put on oxygen, sent to hospital in ambulance, and given 2 bags of fluid through an IV
22 2021-02-09 burning sensation Shortness of breath, Throat tightness and chest tightness, Burning in arms
22 2021-02-10 feeling cold "I have chills, severe intestinal pain, nausea, headache, exhaustion, nasal congestion."
22 2021-02-11 pain in extremity Sore arm, body aches, Nausea, Head ache, Chills.
22 2021-02-11 tingling "Moderna COVID-19 Vaccine " pt received vaccine to his left arm. 10 min later (1335) he reported fe... Read more
"Moderna COVID-19 Vaccine " pt received vaccine to his left arm. 10 min later (1335) he reported feeling dizzy. allergy tech and i evaluated pt. pt clammy with sweat noted to the back of his neck. pt speaking in full complete sentences. no increased WOB. left radial pulse regular and not elevated, not thready. no hives found. denied itchiness. asked pt if he felt anything stuck in his throat, he swallowed a few times and said "yes". asked if he had much water today, he said no. pt reported it felt a little hard to breathe in his throat. i had him remove his mask. pt reported nausea. denied abdominal pain. had him take a few sips of water. reported he no longer felt anything stuck in his throat, no longer hard to breathe in his throat. pt reported tingling in his left arm. pt worked the night shift. went to work at 1600 on 2/11. ate at 2000, beef and potatoes. had snacks. ate chicken and rice at 0300. usually has a full gallon of water on shift but only had a half gallon. got off at 0400. went to sleep at 0530. usually wakes at 1445-1500 but woke up earlier for this appt. appt was at 1330 but he was here early. had a protein shake 30 min before arrival but has not had much water. thinking the protein shake was causing his symptoms. denies working out today, denied energy drink intake, denied any coffee. pt took a large amount of water and then threw up. pt reported he felt much better. nausea resolved. still no itchiness. no hives. no clamminess. no trouble breathing. no globus. no dizziness. no tingling in his left arm. resolved by 1340. held Epi given he reported complete resolution of his symptoms. seemed likely the combination of being underhydrated, having slept less than usual, facility being a little warm and him wearing a mask and possibly his protein shake contributed. had patient wait 30 minutes (1410). allergy tech sat with patient who continued to speak in full sentences, tell stories, etc. had him stand up slowly. denied dizziness. still no hives, no itchiness, no globus, no trouble breathing, no nausea, no abdominal pain. advised pt of reasons to call 911 (he lives on base where we have ambulance services). advised i would be placing a VAERS report.
22 2021-02-14 seizure After about 15 minutes the subject asked to use a pulse oximeter, reading normal. Then said it was l... Read more
After about 15 minutes the subject asked to use a pulse oximeter, reading normal. Then said it was like looking in a tunnel. We asked him to sit an d applied an ice pack to the back of the neck. At the time this provider did not know the patient had a seizure disorder. He slid to the floor with full tonic clonic involvement. His head and neck were protected. 911 was called and an ambulance. After about 3 minutes the subject regained consciousness. He did not wish to be checked out at the hospital. He signed a release and his mother picked him up
22 2021-02-16 migraine Chills and sweating, general soreness throughout the body, difficulty catching breath, migraines, le... Read more
Chills and sweating, general soreness throughout the body, difficulty catching breath, migraines, lethargy.
22 2021-02-16 pain in extremity Stiff arm and slight pain from roughly 2 hours post vaccination till the following morning. Uncomfor... Read more
Stiff arm and slight pain from roughly 2 hours post vaccination till the following morning. Uncomfortable throughout the night
22 2021-02-17 pain in extremity Fever, headache, arm soreness, rash
22 2021-02-18 cold sweat Patient got lightheaded and clammy. Eyes rolled to back of head about 3 minutes after injection. MT ... Read more
Patient got lightheaded and clammy. Eyes rolled to back of head about 3 minutes after injection. MT assessed pulse, slow but steady. RE got BP cuff and took BP. 1st BP reading was 146/96 with pulse of 59. Sat O2 was 100% Staff went to get patient water per patient request. Resident claims he 'lost hearing' for a small time period. BP reading at 1147 was 148/91. SS, CNP, was summoned to vaccination area to assess patient. Spoke with patient / family. He has had similar reaction before after knee surgery. Patient feeling better. CNP requests continued observation until DBP is below 80. BP reading at 1153 is 135/79. Patient released from observation and left vaccination clinic.
22 2021-02-21 hot flush Staff member had hot flash and vertigo upon standing. BP 138/101, P 76, O2 SAT 98%. 5 Minutes later... Read more
Staff member had hot flash and vertigo upon standing. BP 138/101, P 76, O2 SAT 98%. 5 Minutes later BP 132/87, P 77, O2 SAT 99% Symptoms lasted about 5 minutes and he was able to get up and leave without any further symptoms post 15 minutes after injection per staff member's verbal statement. He was leaving his shift to go home.
22 2021-02-21 pain in extremity HA following #2 Moderna vaccine on 16FEB2021. Had fever, bodyache and arm pain which went away. Took... Read more
HA following #2 Moderna vaccine on 16FEB2021. Had fever, bodyache and arm pain which went away. Took 2tabs of 325mg tylenol which is not helpful.
22 2021-02-25 tremor cold shivers followed by uncontrollable shaking and fever
22 2021-02-28 tension headache 0936 vs 92/60, 58, 20, 98%. Pt c/o ringing in both ears, tightness in head and skins were pale and d... Read more
0936 vs 92/60, 58, 20, 98%. Pt c/o ringing in both ears, tightness in head and skins were pale and diaphoretic. Pt denies any SOB, rash, hives, dizziness. Pt?s father is here with him and is his driver. 0946 vs 120/82, 69, 20, 97%. Pt is feeling a bit better. The ringing in the ears and tightness to head is gone, BP has increased and skins are drying and color is returning. This is his first vaccine. Pt did not want any further medical attention/paramedics called. Pt and father were advised to call 911 if any further symptoms occur after leaving site. Pt is feeling back to normal with skins W/D, no other symptoms.
22 2021-03-02 pain in extremity Tiredness, sore throat (mild), sore arm on the injection side
22 2021-03-04 pain in extremity Injection arm soreness worsening throughout the day. Fatigue worsening throughout the day. Headaches... Read more
Injection arm soreness worsening throughout the day. Fatigue worsening throughout the day. Headaches. Body soreness & tiredness. I almost feel like I am in a bit of a fog too.
22 2021-03-07 pain in extremity Fever, Chills, body aches, throwing up, arm pain, swollen, and itchy around area of injection.
22 2021-03-10 tingling PT DISCOVERED INATTENTIVE AN SQUINTING HIS EYES. ONCE ALERT, PT C/O OF LIGHT HEADEDNESS, SWEATING,... Read more
PT DISCOVERED INATTENTIVE AN SQUINTING HIS EYES. ONCE ALERT, PT C/O OF LIGHT HEADEDNESS, SWEATING, BLURRED VISION, PARESTHESIAS IN BOTH ARMS AND LEGS. VS @ 3:08 BP 78/62 HR 86 REPEAT VS @ 3:20 PT GIVEN GATORADE FOR REHYDRATION AND INSTRUCTED TO BREATH SLOW LY AND DEEPLY. AFTER 10 MINUTES, PT SYMPTOMS STARTED TO RESOLVE. SYMPTOMS COMPLETELY RESOLVED WITH TIME. PT BECAME STABLE TO LEAVE OBSERVATION SITE. INSTRUCTED TO F/U WITH PCP.
22 2021-03-12 seizure had a generalized seizure that lasted about two minutes on February 16th. This was preceded by 5-10... Read more
had a generalized seizure that lasted about two minutes on February 16th. This was preceded by 5-10 minutes of intense shivering. has a pre-existing seizure disorder, but the shivering was not typical. In addition, he had another generalized seizure on March 11th. In 2019 and 2020, averaged three seizures per year.
22 2021-03-13 feeling hot Patient became very hot and sweaty after dose. He felt light headed and had to lay down. He was gi... Read more
Patient became very hot and sweaty after dose. He felt light headed and had to lay down. He was given a glucose tablet and Gatorade. He did not have any symptoms of anaphylactic allergy. Emergency responders came and took his blood pressure and blood sugar. Both were a little low. He was not taken to the hospital, he walked out of the pharmacy with his parents
22 2021-03-18 weakness Felt weak, dizzy and passed out about 3 hours after receiving vaccine
22 2021-03-19 unresponsive to stimuli Systemic: Dizziness / Lightheadness-Mild, Systemic: Fainting / Unresponsive-Mild, Additional Details... Read more
Systemic: Dizziness / Lightheadness-Mild, Systemic: Fainting / Unresponsive-Mild, Additional Details: Patient indicated to having had previous fainting episodes. Had a bruise around the right eye after fainting.
22 2021-03-26 pain in extremity 1 hour after, experienced mild soreness around site of inject and elbow of injection arm Ramped up u... Read more
1 hour after, experienced mild soreness around site of inject and elbow of injection arm Ramped up until 4 hours later it was very sore at the shoulder, especially when rotating the shoulder back or lifting it. Pain continued until 9pm day two, when I took a tylenol for relief, along with pain. Around 5pm day 2, fatigue, chills, sore throat, and mild 99 fever began and continued until the tylenol at 9 pm. Day 3, woke up with slight arm pain and very mild cold symptoms, including fatigue and head congestion.
22 2021-03-26 tingling Reports he felt dizzy and bilateral hands tingling few minutes after the vaccine injection Patient ... Read more
Reports he felt dizzy and bilateral hands tingling few minutes after the vaccine injection Patient got out of his car and fell s/p dizziness. Bruises on arms and redness at the back of head. No hematoma Alert and Oriented x 4 BP: 108/87 HR; 99 Sp02: 96% Fingerstick: 95 Seen and transferred to ER for evalualution
22 2021-03-29 pain in extremity Headache Chill Arm-soreness Fatigue
22 2021-03-29 unresponsive to stimuli Pt received the first of the two-series COVID vaccination at 1512. Once in observation area, pt beca... Read more
Pt received the first of the two-series COVID vaccination at 1512. Once in observation area, pt became unresponsive shortly after sitting down. This provider was called over by staff to pt, which was noted to have become unresponsive while sitting in the chair. Pt remained in the chair, did not fall or injure self. Upon arrival to patient, he was noted to have severe diaphoresis, prominent pallor, with shallow, slow breathing, no cyanosis noted. His head initially fell back and head was aligned/adjusted to maintain an open airway. This provider was speaking to the pt and performed a sternal rub to elicit a response, pt remained unresponsive and with eyes closed. Pt remained in this state for approximately 10 seconds. Pt noted to suddenly have some muscular rigidity to arms and torso and in order to prevent injury upon possible onset of seizure activity, pt was lowered to the floor by this provider and RN . Once on the ground the pt was relaxed and opened his eyes. Pt was immediately verbally responsive and asked if he passed out. Pt was able to sit up and was assisted into the wheelchair. Pt moved to treatment area where vitals and blood glucose were obtained. (@1525 BG- 104 mg/dL, VS BP 116/72, HR bradycardic @51 bpm, O2 sat 95%). Patient responses/speech was clear and pt was oriented to self, place, time and situation. Pt stated that he felt nauseated upon sitting in the observation area and admitted that he only had a coffee today, nothing to eat all day and attributed this as the cause of his reaction. Pt verbalized that he would not respond to the hospital with the paramedics and was encouraged to at least call someone to take him to the hospital. This provider spoke with the patient?s mother and explained the events. The patient?s mother stated that the patient had febrile seizures when approximately 4 years old, associated with asthma exacerbations; but pt was evaluated with a neurologist and there were no abnormal findings. Pt admitted that he has a similar syncopal episode after washing a laceration and seeing his finger bleeding. Pt states this was a few years ago and witnessed by his father that told the patient he initially fainted and then became momentarily rigid before responding appropriately (similar to today?s events). Ambulance - arrival @1536 report given and pt stated he was feeling better and declined further evaluation in truck and also declined transport to ED ( departed at 1545). Pt?s overall condition, appearance, including color was much improved. Pt denied any allergies or medication history. Past medical hx of febrile seizures at approximately age three and four, childhood asthma and one syncopal episode as an adult. Pt girlfriend arrival and she agreed to drive patient from the vaccine clinic. Pt and girlfriend were both provided with an explanation of the many concerning causes of syncope and the necessity for further evaluation in the Emergency department to rule out any underlying conditions. Both patient and girlfriend verbalized understanding and although they still declined to respond to ED directly from the clinic, both did agree to respond to ED if any changes in mental status occurred. Pt lives alone, but agreed to stay with parents and family in order to have others watch him for any changes. Pt was advised to followup with PCP and made aware that an provider would contact him tomorrow to check on his status, understanding verbalized and agreed with plan of care. Pt in no acute distress, awake, alert and oriented. Color within normal limits for and departed facility with girlfriend at 15:56, steady gait noted. Patient?s appointment for second dose was cancelled and will need to obtain clearance prior to second vaccine dose.
22 2021-03-30 pain in extremity Headache, elevated blood pressure, chills & shivering, right arm & back pains,
22 2021-03-30 pain in extremity Lymph node in injection arm swollen and painful. Dull ache present in entire arm. Began two days aft... Read more
Lymph node in injection arm swollen and painful. Dull ache present in entire arm. Began two days after injection, became significantly more unpleasant on day 7. It is still day 7 at the time of this writing.
22 2021-03-30 seizure 1124 End of 15 minute observation period. Per witness, attempted to stand and fell forward onto flo... Read more
1124 End of 15 minute observation period. Per witness, attempted to stand and fell forward onto floor. Seizure noted for one minute, responded to name and answered questions appropriately. Stated he "felt dizzy". Vital signs 118/60, 99%, 54. Blood glucose 97. Physician Assistant, present. Questions answered. 1131 Attempted to stand patient up again with assistance/supported X2. Stated he "felt dizzy again and blurry vision". Fainted while supported X2. Positioned on left side and immediately responded. Positioned supine. 1133 Vital signs 110/60, 96%, 72. 1142 Sitting up awaiting EMS, answers questions appropriately.. EMS present 1145 Vital signs 128/76, 100%, 72.
22 2021-03-31 feeling hot A spontaneous report was received from a Consumer concerning a 22 years old male patient who receive... Read more
A spontaneous report was received from a Consumer concerning a 22 years old male patient who received Moderna's COVID-19 vaccine (mRNA-1273) and experienced cellulitis, skin felt hot/feeling hot, arm was red/redness generalized, arm was swollen/peripheral swelling. The patient's medical history was not provided. No relevant concomitant medications were reported. On 14 Jan 2021, prior to the onset of the events, the patient received their first of two planned doses of mRNA-1273 (lot/batch: 012L20A) intramuscularly in the left arm for prophylaxis of COVID-19 infection. On 15 Jan 2021, the patient experienced the events as cellulitis, skin felt hot, arm was red, arm was swollen. Treatment information was provided as patient has taken antibiotic Cephalexin 1 capsule four times a day for a week. Action taken with mRNA-1273 in response to the events was unknown. The seriousness criteria of event cellulitis was assessed as serious as per EMA list. The outcome of the event swollen arm was resolved. The outcome of the events cellulitis, skin felt hot, arm was red was unknown.; Reporter's Comments: Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded.
22 2021-04-01 pain in extremity Fatigue, arm sorness, headache, body ache, chills, low grade fever, nauseous
22 2021-04-01 pain in extremity Severe pain over entire upper body. However that subsided the next day and left my left arm still in... Read more
Severe pain over entire upper body. However that subsided the next day and left my left arm still in severe pain and stiffness, despite pain pills, warmth compress, voltaren gel application, and rest.
22 2021-04-01 tremor, feeling hot Around 11:30pm I started to get chills and my teeth started to chatter. At the same time my body was... Read more
Around 11:30pm I started to get chills and my teeth started to chatter. At the same time my body was shaking slightly. I was laying on the couch during the start of it for the above events, this lasted for about 20+ minutes. Then I tried to get up to go to bed. I was shaking very badly at this point, teeth chattering a lot and I was very cold. I tried to use the bathroom and I couldn't even stand still to use the bathroom. My chest was also tightening and it was hard to breathe. I went to bed to lay down and I was practically hyperventilating for about 15 minutes at a time and I would stop for a minute then it would start up again. I tried to go to sleep but I couldn't because I couldn't breathe and my chest was closing in, it felt like. I called my parents in and they sat with me and gave me ibuprofen and benedryl. I started to feel better after about an hour. During that time, though, my body was extremely hot (but no fever) but I was still cold and had the chills. My head also was hurting like a headache and my eyes were really hot too. It was hard to get air and if I sat up I would get dizzy.
22 2021-04-02 flushing Within 3 minutes of being escorted to our waiting area and starting the timer, patient made a compl... Read more
Within 3 minutes of being escorted to our waiting area and starting the timer, patient made a complaint of sweating. within moments patient was heavily perspiring and lost all color. Flushed and confused. Pt starting asking "how long have I been here?". then while being escorted back to our vaccine room patient experienced a brief syncope. He fainted and was escorted to the ground. Increased pulse and continued confusion. Patient was placed in supine position with ice packs on face and nape of neck. EMS was called. we stayed with patient until EMS arrived and took over. Patient declined going with them to the hospital after his evaluation and was cleared by EMS to leave.
22 2021-04-03 tingling, pain in extremity Patient had his 1st dose of the Moderna vaccine & developed commonly reported side effects, sore arm... Read more
Patient had his 1st dose of the Moderna vaccine & developed commonly reported side effects, sore arm & fatigue shortly after the vaccine was administered. As the week continued past 48 hours post injection period, he was experiencing extreme fatigue & muscle aches. On the morning of 3/29 his feet were tingling & his legs were stiff. When he woke up on 3/30 the stiffness in his legs & the tingling increased to the point where walking became difficult. Finally on the morning of 3/31 he could not walk without assistance. His PCP said to take him to the emergency room. Patient was admitted to Medical Center with the suspicion of Guillain Barre Syndrome. A lumbar puncture confirmed Guillain Barre on 4/1/21 and a 5 day course of IVIG was started immediately after confirmation of diagnosis.
22 2021-04-03 tremor NO ADR. Patient was anxious due to needle. He had his vaccine and was asked to sit on chair for 15 m... Read more
NO ADR. Patient was anxious due to needle. He had his vaccine and was asked to sit on chair for 15 minutes. After sitting for 5 minutes, he suddenly fell down from the chair, lying on floor head down. He was anxious and a bit shaky, but conscious of surrounding. He was talking while lying down. Patient refused to call 911 and did not wanted any help. Patient's father was shopping in store and was called to pharmacy. Patient laid down on floor for few minutes and then sat back on chair. After 10 minutes, he was perfectly fine and left the site with his father.
22 2021-04-04 pain in extremity Sore arm, fever, congestion, headache, fatigue,
22 2021-04-04 seizure Patient had fallen out of chair approximately 5 minutes after being vaccinated and showed signs of h... Read more
Patient had fallen out of chair approximately 5 minutes after being vaccinated and showed signs of having seizure (jerking motions) for approximately 30 seconds. We rolled patient on his side while he was having seizure and rolled him onto his back when he stopped seizing. Patient regained consciousness and was profusely sweating. Fire department showed up to take over. They had questioned patient on his medication history and whether he had a history of seizures. Approximately 15 minutes from then, the paramedics arrived and preformed vital check on patient and deemed patient unwell to leave on his own accord. Patient was then transmitted to hospital.
22 2021-04-06 flushing pt received 1st dose, reported felt like passing out and stood up from the chair. Patient fell bac... Read more
pt received 1st dose, reported felt like passing out and stood up from the chair. Patient fell backward, hit a door, and landed on the floor. Momentary loss of consciousness (about 5-10 seconds) but recovered quickly. Pt was unaware he fall initially. Initial BP standing was low, was sweaty, skin was flush. After laying down BP 124/90. O2 set 98%. HR = 69. Provided water and rest. Review of system by physician shows no neuro deficit, and deemed to have recovered 40 minutes post fall.
22 2021-04-07 feeling hot Sluggishness, profuse sweating, feeling overheated and dehydrated, in/out of alertness, and "not bei... Read more
Sluggishness, profuse sweating, feeling overheated and dehydrated, in/out of alertness, and "not being able to see" Patient reported symptoms within 5 to 10 minutes after receiving vaccination. Symptoms resolved over 15 minutes.
22 2021-04-07 pain in extremity On April 06, 2021 this 22 -year-old male patient received the Moderna Covid vaccine on his left delt... Read more
On April 06, 2021 this 22 -year-old male patient received the Moderna Covid vaccine on his left deltoid at 1937. That same evening, the patient complained of pain on his left arm, and received acetaminophen 650 mg by mouth at 21:24. On April 07, 2021, I spoke with the provider and he stated the patients' pain had resolved.
22 2021-04-07 tremor I began to have tremors throughout my whole body after getting the vaccine both times, the first tim... Read more
I began to have tremors throughout my whole body after getting the vaccine both times, the first time it lasted for probably about 2-3 weeks. At one point it got so bad that I visited the ER but got no results.
22 2021-04-08 tingling Chills for 2-3 hours of duration following 5 hours after vaccination, nausea, The following morning:... Read more
Chills for 2-3 hours of duration following 5 hours after vaccination, nausea, The following morning: 10/10 non-radiating chest pain of pleuritic feeling, tingling in limbs, syncope, SOB Tachycardia(108 bpm)
22 2021-04-09 weakness, cold sweat Symptoms: - loss of sight (blackout) - weakness - cold sweats - ringing in both ears - comparable to... Read more
Symptoms: - loss of sight (blackout) - weakness - cold sweats - ringing in both ears - comparable to low blood sugar reaction - pale skin Time Course until symptoms dissipated ~10 minutes Course of action: - returned to pharmacy and notified staff - sat and placed head between legs - remained with pharmacist for approximately 5 minutes - drank water and Poweraid - then moved to chair outside pharmacy and sat for 45 minutes continuing to drink poweraid - walked around store for about 15 minutes - notified staff that I was feeling better - left store
22 2021-04-12 weakness BLURRED VISION WEAKNESS , BLOOD PRESSURE 110/70 HEAR RATE 84, RESP 18 COLOR PALE , PATEINT WENT BY ... Read more
BLURRED VISION WEAKNESS , BLOOD PRESSURE 110/70 HEAR RATE 84, RESP 18 COLOR PALE , PATEINT WENT BY WHEEL CHARI TO FIRST AID RESTED FOR 1 HOUR BEGAN TO FEEL A LITTLE BETTER DURING THIS TIME DRANK SOME WATER AND WAS BEING PICKED UP BY FRIEND DID NOT DRIVE HOME ADVISED IF HAD INCREASING SYPTOMS OR RESP DISTRESS TO GO TO THE ER , VERBALIZED UNDERSTANDING
22 2021-04-12 cold sweat became clammy and pale in color initial b/p 91/63 and pulse 63 called MD for assessment water oven... Read more
became clammy and pale in color initial b/p 91/63 and pulse 63 called MD for assessment water oven and crackers B/p 99/48 after siting for additial 30 minutes bp/ 99/64 MD advised client to follow-up with doctor.
22 2021-04-12 migraine I got the Covid-19 vaccine on Tuesday April 1st and then 2 days later on Thursday April 3rd I starte... Read more
I got the Covid-19 vaccine on Tuesday April 1st and then 2 days later on Thursday April 3rd I started developing headaches and they got worse and I would say they fluctuated to migraines. Every day I would have a degree of a migraine (which I do NOT have history of) and most days the head pain limited my activity significantly. I had 2 evenings where it got really bad. Once on Saturday April 3rd and then again on Wednesday April 7th. I have had headaches continueally since then. Some days better than others and some days worse.
22 2021-04-14 cold sweat arrived to post observation after his first dose of Moderna. Pt stated he was dizzy. Pt appeared pa... Read more
arrived to post observation after his first dose of Moderna. Pt stated he was dizzy. Pt appeared pale. Pt was A+Ox4. Medics were called and initial BP was 88/40. Pt states hx of syncope after shots. Pt was given juice and water and was able to speak during his entire time in post observation. Pt began to state he was feeling better but just wanted to sit for a while. Pt was clammy and states "I knew this would happen". Pt BP and HR rose to WNL. Pt standing without dizziness. EMTs released Pt at 1650 to continue monitoring a bit longer. 1630 Vitals BP 88/40 HR 50 RR 18 O2 sat on RA 98% 1635 VS BP 90/50 HR 70 O2 on RA 99% 1640 BP 108/62 1645 VS BP 112/60 HR 72 O2 Sat on RA 98%
22 2021-04-14 discomfort, numbness Pt. did not eat or drink, feels numbness in face and tongue. Body felt heavy (only had a protein mi... Read more
Pt. did not eat or drink, feels numbness in face and tongue. Body felt heavy (only had a protein milkshake this morning) BP: 130/26; HR: 65
22 2021-04-14 throat numbness c/o mild numbness to the throat and anxiety. Denies chest pain, SOB, swollen tongue, or difficulty s... Read more
c/o mild numbness to the throat and anxiety. Denies chest pain, SOB, swollen tongue, or difficulty swallowing. Vital signs : BP: 140/98 HR: 77 Sp02: 98% room air Refusal form signed for ER transfer. Patient states symptom is mild. advised to go to ER if symptom worsen, verbalized understanding seen and cleared by EMS
22 2021-04-15 pain in extremity Nausea, acheyness, sore arm, cough, and headache are the symptoms. I treated them with Tylenol, lot... Read more
Nausea, acheyness, sore arm, cough, and headache are the symptoms. I treated them with Tylenol, lots of sleep, and Sprite.
22 2021-04-16 migraine Patient presented with two days of headache most consistent with a migraine after receiving the seco... Read more
Patient presented with two days of headache most consistent with a migraine after receiving the second dose of the Moderna vaccine. Her neurologic exam was normal and she was treated with oral medications and her headache resolved.
22 2021-04-17 pain in extremity Around 3 pm on 4/14/21, I started to feel very tired and I started to get a headache. Around 6 pm, I... Read more
Around 3 pm on 4/14/21, I started to feel very tired and I started to get a headache. Around 6 pm, I started to experience lower back pain and my legs began to throb and my whole body became very sensitive to touch. I took tylenol or ibuprofen every 4 hours for the rest of the night. This went on until Thursday 4/15/21, when the dizziness and throbbing headache started. Every time I would stand up I would become off balanced and need to hold on to something. I was still experiencing the lower back pain, leg throbbing and skin sensitivity but the dizziness and headache became much more intense. Around 9:30 pm on Thursday, I felt like I was hallucinating and was experiencing euphoria along with a fever. I did not sleep the night of 4/15 into 4/16. I was sweating profusely with a throbbing headache that would cause spinning when I would stand up. Around 3 am on 4/16, I fell asleep until around 4:30 am when I woke up in a pool of my own sweat. The body aches, leg pain and skin sensitivity went away along with my fever. Throughout Friday 4/16, I had a throbbing headache and was dizzy with no relief. This continued into Sunday 4/18 when I started to feel some relief. My headache was pretty much gone but the dizziness is still very much there. I have also an experienced elevated heart rate and respirations throughout the last 5 days.
22 2021-04-18 feeling cold Muscle Pain (All Body) Sat. 1pm-Sun End of Day Fatigue (All Body) Sat. 1pm-Mon. 6am Cold Chills Sat.... Read more
Muscle Pain (All Body) Sat. 1pm-Sun End of Day Fatigue (All Body) Sat. 1pm-Mon. 6am Cold Chills Sat. 1pm-Sun. 10am. Dizziness Sat. 1pm-Sun. 10am. Nausea Sat. 1pm-Sun. 10am.
22 2021-04-19 weakness Patient had full syncope episode approximately 15 minutes after receiving the vaccine. Patient was ... Read more
Patient had full syncope episode approximately 15 minutes after receiving the vaccine. Patient was able to arouse quickly. Vital Signs: 1320: BP-124/73 P-74 R-16 Pox-95% 1328: BP-114/77 P-84 R-24 Pox-97% No trauma sustained in fall. Patient alert and orientedx3. Patient remains very pale and weak. Transported to Emergency Room via ambulance for further assessment.
22 2021-04-19 flushing Approximately 3 to 5 minutes after immunization, patient was observed in a waiting room chair uncon... Read more
Approximately 3 to 5 minutes after immunization, patient was observed in a waiting room chair unconscious, unresponsive and not breathing (respiration was not immediately observable or recognizable). Patient was carefully and quickly placed in a supine position on the floor. Pulse was present but the patient was completely unresponsive. Respiration was not observed. EMS was immediately notified. Pharmacist and staff prepared for resuscitation and utilization of Epinephrine if needed. Patients face was flushed, arms became flushed and the patients skin became moist. After approximately 45 seconds in the supine position the patients eyes opened and he became responsive to auditory communication. Respiration became reestablished. BP was recorded at 130/91 with a pulse of 91 BPM. EMS arrived on scene and provided further evaluation. After an additional 5-10 minutes, patient was completely conscious and coherent. Patient indicated that he had a similar experience in a grocery store over 1 year ago that was unrelated to immunization and was attributed to dehydration. Patient refused additional medical care or transport to ED. Patient was released to a friend who drove him home. Patient was observed 1 day later picking up his car from the pharmacy and has recovered. Patient was advised to seek additional medical evaluation to assess the root cause of this event.
22 2021-04-21 weakness ~6 hours after shot started to feel body pain and headache. Got worse and added in fever, weakness a... Read more
~6 hours after shot started to feel body pain and headache. Got worse and added in fever, weakness and nausea. Was the worst 9-12 hours after the shot. For the rest of the next day I still felt bad but condition slowly improved. Took Tylenol a few times which helped a bit
22 2021-04-21 numbness Symptoms: Extreme pain immediately after injection at site, closely followed by racing heart and win... Read more
Symptoms: Extreme pain immediately after injection at site, closely followed by racing heart and winded and dizzy, followed by sweating, blurred vision and confusion. Don't remember hitting horn to alert officials. Got out of car, dizzy and stumbled. Blacked out and fell to pavement. Don't remember falling, woke up with extreme mind cloudiness, drowsiness, and hands were numb to touch but felt extreme pressure on palms. When pressure subsided, finger tips felt inflamed.
22 2021-04-21 sensory loss AFTER 10 HOURS OF ADMINISTRATION OBSERVED SEVERE ARM CONTRACTURE - 15 MINUTES OF BOTH ENTIRE ARM S... Read more
AFTER 10 HOURS OF ADMINISTRATION OBSERVED SEVERE ARM CONTRACTURE - 15 MINUTES OF BOTH ENTIRE ARM STIFFNESS AND FINGER CURL LASTING AT LEAST 15 MINUTES. PT LOST SENSATION IN HIS ARMS UP TO HIS ELBOWS AND BOTH HANDS. HE ALSO SUFFERED ARM SORNESS AT THE INJECTION SITE, HEADACHES, FATIGUE, VOMITING AND JOINT PAIN, AND RASH AROUND HIS EYES. UPON HIS REPORT TO ME A FEW HOURS LATER HE HAS RESUMED SENSATION IN HIS ARMS AND IS FEELING SOMEWHAT BETTER NOW.
22 2021-04-24 unresponsive to stimuli Systemic: Dizziness / Lightheadness-Severe, Systemic: Fainting / Unresponsive-Severe, Additional Det... Read more
Systemic: Dizziness / Lightheadness-Severe, Systemic: Fainting / Unresponsive-Severe, Additional Details: after receiving the Moderna Covid 19 vaccine, the patient passed out in the chair. When I got to him, he was unresponsive, but within seconds he became alert. He said he had a history of passing out after medical procedures (when seeing a md after finger surgery). He layed down for about 20 minutes, then sat back in chair. About 30 min after passing out, he said he was dizzy and passed out a 2nd time. He became alert after about 10 seconds. He was here about 30 more min then felt ok and left.
22 2021-04-26 flushing Systemic: Dizziness / Lightheadness-Severe, Systemic: Flushed / Sweating-Medium, Systemic: Nausea-Se... Read more
Systemic: Dizziness / Lightheadness-Severe, Systemic: Flushed / Sweating-Medium, Systemic: Nausea-Severe, Systemic: Vomiting-Medium
22 2021-04-27 cold sweat, feeling hot Pt reports becoming warm, clammy, with minor tinnitus in left ear. No hx of allergy. Placed in semif... Read more
Pt reports becoming warm, clammy, with minor tinnitus in left ear. No hx of allergy. Placed in semifowler position on cot. BP 110/80 HR 60, RR 14 SPO2 98%. at 10:05 SPO2 up to 99% and he reports being asymptomatic. He stood up with no vagal response.
22 2021-04-27 numbness right hand numb, dizzy, chills
22 2021-04-27 seizure, involuntary muscle movements Patient was given their first dose of the Moderna COVIDvaccine. Within 1 minute, the patient began h... Read more
Patient was given their first dose of the Moderna COVIDvaccine. Within 1 minute, the patient began having a seizure (jerking, eyes rolled back in the head, head went limp, and his body stiffed up), and then went unconscious.
22 2021-04-27 tremor Pt received the vaccine in l-deltoid area and within seconds lost consciousness. After being unconsc... Read more
Pt received the vaccine in l-deltoid area and within seconds lost consciousness. After being unconscious for roughly ten seconds, pt was arousable by calling his name and lightly shaking him. Pt was seated during his loss of consciousness, was caught by the nurse administering the shot, pt did not hit his head or suffer any trauma. Pt was assisted to a stretcher, given water to drink and his vital signs were monitored. Upon initial assessment, pt was A&O x 4, GCS 15, blood pressure 88/60, pulse 58, pupils equal and reactive to light, lung sounds clear, respirations 16 and non-labored. Pt denied ever fainting before, denied any allergies, medical history, denied taking prescription or over the counter medications, and denied birth defects. Pt was reassessed after about 5 minutes of initial assessment. A&Ox4, GCS 15, BP102/68, PR 78, PEARL, LS clear, RR 16 non-labored. Pt was continuously monitored for 30 minutes and advised to follow up with his primary doctor for an assessment of new-onset syncopal episode. PT's mood improved and was reassessed for vitals before leaving the clnic. A&0x4 GCS 15, BP 118/80, PR 84, PEARL, LS clear, RR 16-non-labored, PT released from care and exited the site with no further findings.
22 2021-04-28 cold sweat pt tipped his head back and then fell & caught himself ( maybe fainted for 2 seconds) extremely ... Read more
pt tipped his head back and then fell & caught himself ( maybe fainted for 2 seconds) extremely white, clammy, sweaty, light headed. sat with him and he drank water ,for 15 minutes friend brought him home.
22 2021-04-28 discomfort The patient has had pain redness and swelling at the site of injection for the past week. on Day 5 h... Read more
The patient has had pain redness and swelling at the site of injection for the past week. on Day 5 he developed a diffuse rash throughout his chest abd and back. It is ichy and a bit uncomfortable.
22 2021-04-28 flushing, numbness Patient complained of dizziness and light headed and started having numbness in hand including finge... Read more
Patient complained of dizziness and light headed and started having numbness in hand including fingers where injection was. Patient reported no pain just numbness patients Pulse 72, R 18, BP 130/88. Gave patient water because he felt warm and flush and fanned him. Patient stated he was feeling better during post-op except the tingling and numbness. Informed patient after 25 minutes in post-vac that he should seek medical attention, go to Emergency Room or contact his doctor if the tingling and numbness do not go away or get worse. Patient left with wife and side he was okay.
22 2021-04-28 flushing Systemic: Dizziness / Lightheadness-Mild, Systemic: Flushed / Sweating-Mild, Systemic: Headache-Mild
22 2021-04-28 pain in extremity Day of shot: sore arm within 30 minutes of the vaccine, headache slowing worsening throughout the da... Read more
Day of shot: sore arm within 30 minutes of the vaccine, headache slowing worsening throughout the day, and little nausea before going to sleep. Following morning I have a bad headache and took 2 Aleve while feeling like I just want to throw up.
22 2021-04-28 seizure About 5 minutes after receiving his 1st moderna covid vaccine, patient fainted and began to convulse... Read more
About 5 minutes after receiving his 1st moderna covid vaccine, patient fainted and began to convulse briefly (less than 1 minute). Patient was seated the entire time and did not experience any known injuries. Paramedics were called and stated vitals were normal. Patient followed up with a physician that said the reaction was due to vasovagal syncope. He felt fine afterwards and followed up a few hours to say he was ok.
22 2021-05-02 tingling Patient felt slight shortness of breath, sweats/chills, tingling in the right extremity, mental fog/... Read more
Patient felt slight shortness of breath, sweats/chills, tingling in the right extremity, mental fog/fatigue, nausea within 10 minutes of being vaccinated with the first dose. Patient reported not having swelling or tingling in lips/tongue/throat. Patient reported not having much to eat or drink prior to coming in for his vaccine. Called 911 due to patient's complaints and concern about him having a possible allergic response.
22 2021-05-03 pain in extremity About 2 hours after, I developed a sore arm. At 6:30am the following day, I woke up with a 102 degre... Read more
About 2 hours after, I developed a sore arm. At 6:30am the following day, I woke up with a 102 degree fever, chills, a headache, and the sweats. They went away with tylenol and fluids.
22 2021-05-03 pain in extremity Strong headaches day after second shot, went away after ibuprofen at 10pm (on the day after the shot... Read more
Strong headaches day after second shot, went away after ibuprofen at 10pm (on the day after the shot). Arm sore for a few days for both, nothing bad though, just felt like a bruise.
22 2021-05-05 unresponsive to stimuli Systemic: Fainting / Unresponsive-Mild, Additional Details: Patient waited in post vaccine area for ... Read more
Systemic: Fainting / Unresponsive-Mild, Additional Details: Patient waited in post vaccine area for 15 mins post vaccine. After about 10 minutes the patient fainted from where he was seated in his chair onto the floor and another customer described him as "rigid". He came to after less than a minute. Patient was kept for observation for 30 minutes and given water. He stated he has had fainting spells in the past and that he felt fine. His mother came to pick him up.
22 2021-05-06 pain in extremity Sense of taste completely destroyed. Meat tastes like sulfur or metal. Rancid. It?s lasted for at le... Read more
Sense of taste completely destroyed. Meat tastes like sulfur or metal. Rancid. It?s lasted for at least 5 days so far. Can?t eat meat because of it. Can?t taste the majority of vegetables. The only things that taste good/normal are sweets, because of course Aching pain in right calf/hamstring but not in left
22 2021-05-08 feeling cold Extreme shivering that woke me up, took much longer than usual to get warm. Next morning, I had a he... Read more
Extreme shivering that woke me up, took much longer than usual to get warm. Next morning, I had a headache and 100 degree fever
22 2021-05-11 pain in extremity Presented with left neck, chest and upper extremity weakness, pain and burning that started on 5/1.... Read more
Presented with left neck, chest and upper extremity weakness, pain and burning that started on 5/1. Stroke protocol followed and alteplase given 5/2. By morning of 5/3 all symptoms had resolved.
22 2021-05-12 feeling hot Patient received shot in Left arm and after a few minutes became to feel dizzy and warm. Patient fe... Read more
Patient received shot in Left arm and after a few minutes became to feel dizzy and warm. Patient felt nauseous. Pharmacist applied Ice pack to patient's head. Dizziness and warmness subsided after 5 minutes.
22 2021-05-12 migraine Severe migraine and fatigue. Lasted from 8pm the day of the vaccination until the morning 2 days aft... Read more
Severe migraine and fatigue. Lasted from 8pm the day of the vaccination until the morning 2 days after the vaccination. No treatment was done
22 2021-05-13 feeling hot, tingling Pt felt nauseous, hot, started getting red, and sat down on floor about 5 minutes after receiving th... Read more
Pt felt nauseous, hot, started getting red, and sat down on floor about 5 minutes after receiving the vaccine. I was alerted and I helped him into the vaccination room to lay down on the floor with his feet propped up. His girlfriend was there to help calm him down. I offered to call 911, he refused. I grabbed a fan for him, and turned it off when he requested. He then began shivering rather uncontrollably and said his left arm (injection site) was hurting and tingling, and at one point, said his right arm was beginning to tingle as well. We had him breath and relax, he began to return to normal and he and girlfriend discussed how he must be partly having an anxiety/panic attack. He trialed standing up a few times until he felt good enough to leave the room, all in all about 20 minutes. He sat close by for additional 15 minutes of observation, at which point he left stating he felt more like himself.
22 2021-05-17 feeling of body temperature change nausea, chest tightness, fever, diarrhea, vomiting, hot and cold flashes, mile severity, came on sud... Read more
nausea, chest tightness, fever, diarrhea, vomiting, hot and cold flashes, mile severity, came on suddenly after second dose, resting with moderate improvement, lethargic, moderate appetite
22 2021-05-19 discomfort It started off with me becoming really irritable over the smallest things. I started getting cold c... Read more
It started off with me becoming really irritable over the smallest things. I started getting cold chills even though it was 70F. I had a nightmare that felt like an eternity. My dreams get warped when I'm sick. I woke up and I had a headache that was centered around several spots in my head. I couldn't get comfortable no matter what I did. It's impossible to lay down on the side you get the shot on. It hurt like... 7x more than the first one when they're administering it. The scariest symptoms though, for me, was that I couldn't catch my breath. You know when you take a hot shower and you can't really breathe 100% because of the steam? That's how I felt all day after the 2nd dose. Also, I couldn't tell if I was full or not when I ate. The only way I could tell was stomach pains. That's all that's happening/has happened to me. I do feel better alot better though two days after having the 2nd dose.
22 2021-05-19 feeling hot, tingling Within 10 minutes of receiving vaccine, the patient became hot and sweaty, felt like pins and needle... Read more
Within 10 minutes of receiving vaccine, the patient became hot and sweaty, felt like pins and needles sticking and itching all over, felt as if he couldn't breathe. BP 184/143. He then began projectile vomiting. I administered and epipen (one dose) and had pharmacy staff call 911. He began feeling better within a couple of minutes, and by the time EMT's arrived, his BP back down to 118/73 and he stated he felt fine. They transported him to the ER. I called patient approx 6 hours later. He stated that he was home without further treatment from the ER and felt fine.
22 2021-05-19 migraine, pain in extremity Chills, fever, exhaustion, soreness in left arm, small migraine behind eyes
22 2021-05-19 migraine my son had swelling in his throat and mouth , confusion and mild delerium after the second dose , ... Read more
my son had swelling in his throat and mouth , confusion and mild delerium after the second dose , fever of 101-103. vomiting , Muscle aches , migraine headache
22 2021-05-19 tremor Chills, shakes, muscle soreness, injection sight pain, headache, tiredness,
22 2021-05-20 seizure, unresponsive to stimuli Felt lightheaded, dizziness, then leaned back passed out and was unresponsive with convulsions for 5... Read more
Felt lightheaded, dizziness, then leaned back passed out and was unresponsive with convulsions for 5 seconds then started responding again. Couldn't see for 15 seconds then threw up. After fluids and crackers waited for 20 minutes and then was fine.
22 2021-05-22 numbness, feeling hot A patient received the first dose of the Moderna Covid vaccine. After about 10 min, he suddenly got ... Read more
A patient received the first dose of the Moderna Covid vaccine. After about 10 min, he suddenly got really hot and started sweating profusely. He also reported numbness in his right arm and mild difficulty breathing. He then began to vomit. One 0.3mg EpiPen was administered and 911 was called. He began feeling better immediately and left the pharmacy with paramedics.
22 2021-05-23 flushing Systemic: Abdominal Pain-Severe, Systemic: Body Aches Generalized-Severe, Systemic: Chills-Severe, S... Read more
Systemic: Abdominal Pain-Severe, Systemic: Body Aches Generalized-Severe, Systemic: Chills-Severe, Systemic: Dizziness / Lightheadness-Medium, Systemic: Flushed / Sweating-Severe, Systemic: Headache-Medium, Systemic: Nausea-Severe, Systemic: Vomiting-Severe, Additional Details: AFTER RECEIVING THE VACCINE, AROUND 3PM, PT SEEMED AOX3, AFTER ABOUT 5 MINUTES, PATIENT BECAME EXTREMELY PALE AND BECAME EXTREMELY FLUSHED, AND WAS PERSPIRING. PATIENT CONCOMITTANTLY BECAME NAUSEOUS WITH ABDOMINAL PAIN, AND HEADACHE, AFTER WHICH (~5MIN) PROCEEDED TO VOMIT. PATIENT LEFT STORE AFTER ABOUT 30 MINUTES AFTER HE BEGAN TO FEEL BETTER. SPOKE WITH PT BRIEFLY THIS MORNING (5/24/2021) AND PT STATED HE IS FEELING MUCH BETTER, AND HAD NO ADDITIONAL S/Sx OF VACCINE REACTION.
22 2021-05-25 pain in extremity Day one: Pain in arm, drowsiness Day two: Heavy pain in arm, 100° fever, headache Day three: ?Roc... Read more
Day one: Pain in arm, drowsiness Day two: Heavy pain in arm, 100° fever, headache Day three: ?Rock in stomach? feeling, went away after a few hours
22 2021-05-25 pain in extremity Very serious aches and pains in my joints. Fever, sore throat, pain in arm. Swollen glands and stiff... Read more
Very serious aches and pains in my joints. Fever, sore throat, pain in arm. Swollen glands and stiff joints. All started around 9 Pm
22 2021-05-26 seizure patient with hx of epilepsy controlled, no seizures since 2018 on Depakote and lamictal, after secon... Read more
patient with hx of epilepsy controlled, no seizures since 2018 on Depakote and lamictal, after second dose of Moderna vaccine two days later has had 7 seizures in one week. No other obvious seizure trigger.
22 2021-05-27 face paralysis, facial paralysis, bell's palsy I got diagnosed with Facial Paralysis (Bell's Palsy) on the left side of the face. One of the signs... Read more
I got diagnosed with Facial Paralysis (Bell's Palsy) on the left side of the face. One of the signs were weakness on my face when trying to make gestures. The day before (May 15, 2021) I got a headache and when I woke up the other day I felt the weakness in my face. By the end of the day around 9:00 pm I went to the Emergency Room and got injected with Decadron, but the doctor didn't diagnosed me nothing only to see a Neurologist. The other day (May 17, 2021) I tried to get in contact with my primary doctor to explain the situation but I had to wait for the next day for an appointment. By the end of the day (May 17, 2021) I went again to another Emergency Room where the doctor Diagnosed with Facial Paralysis (Bell's Palsy). He ordered a CT Scan, blood sample and anti-inflammatory.
22 2021-05-28 unresponsive to stimuli Site: Pain at Injection Site-Mild, Site: Redness at Injection Site-Mild, Systemic: Confusion-Mild, S... Read more
Site: Pain at Injection Site-Mild, Site: Redness at Injection Site-Mild, Systemic: Confusion-Mild, Systemic: Fainting / Unresponsive-Severe, Additional Details: On 5-28-21 the patient was given the COVID vaccine, following the vaccine he passed out. When the patient came to he said he must have gone to sleep. The patient stated he passed out the week before and thought it was due to not eating. EMS checked vitals, and all vitals were good. Pt refused to go to the hospital, he left with his wife and she drove. I told the patient I would follow up with him via a phone call to see how he was feeling. I called pt at 5 pm on 5-28, he stated he was fine
22 2021-06-03 muscle twitching Three to five minutes following vaccine administration patient was collapsed to the ground then imm... Read more
Three to five minutes following vaccine administration patient was collapsed to the ground then immediately got up and sat on the floor. When I got to him he was sweating and his arms were twitching. Even though he was alert, he was struggling to straighten his arms. I made a 911 call and then administered one dose of epipen then within a minute he thanked me for the epipen and he said he is feeling much better. Finally the paramedics came in and asked him if he still wants to go for further checkups. He agreed and left the store with the paramedics.
22 2021-06-05 pain in extremity chills, nausea, vomiting, headache, arm soreness, fatigue
22 2021-06-06 seizure Systemic: Seizure-Medium, Additional Details: Patient had a seizure, 24 hours post vaccine. Patient ... Read more
Systemic: Seizure-Medium, Additional Details: Patient had a seizure, 24 hours post vaccine. Patient went to ER where they found a subdural hematoma
22 2021-06-08 migraine Headache (migraine); body aches, muscle soreness, temperature (chills), fatigue
22 2021-06-08 seizure, muscle twitching ABOUT 30 SECONDS AFTER THE SHOT WAS ADMINISTERED THE PATIENT HAD A SEIZURE WHILE SITTING IN THE CHAI... Read more
ABOUT 30 SECONDS AFTER THE SHOT WAS ADMINISTERED THE PATIENT HAD A SEIZURE WHILE SITTING IN THE CHAIR IN THE WAITING ROOM. FULL BODY TWITCHING AND EYES ROLLING FOR 15 SECONDES OR SO. LEFT ARM WAS ALSO SWOLLEN AT THE ELBOW WHICH WAS OPPOSITE ARM OF THE IMMUNIZATION. PARAMEDICS WERE CALLED AND PATIENT WAS EVALUATED IN THE AMBULANCE BUT CHOSE NOT TO GO TO THE HOSPITAL AND TOLD THE PARAMEDICS HE WOULD GO ON HIS OWN. STILL HAS NOT BEEN SEEN PER PATIENT.
22 2021-06-15 unresponsive to stimuli, flushing Systemic: Fainting / Unresponsive-Medium, Systemic: Flushed / Sweating-Medium, Additional Details: P... Read more
Systemic: Fainting / Unresponsive-Medium, Systemic: Flushed / Sweating-Medium, Additional Details: Patient got up from observation to ask for a glass of water. On the way back to his seat, he fainted into the aisle and fell to the floor. Upon hitting the floor he immediately woke up and was profusively sweating. The patient was taken out by the EMT after 911 was called. Patient said he felt fine and back to normal after waking up and that he has fainted due to vaccines before.
22 2021-06-17 feeling hot Approximately 10 min into the post-vaccination waiting period, patient collapsed out of his chair. ... Read more
Approximately 10 min into the post-vaccination waiting period, patient collapsed out of his chair. Patient stated that he started feeling hot and dizzy and that's all he remembers/
22 2021-06-18 tremor Systemic: Dizziness / Lightheadness-Mild, Systemic: clenched fists----rigid muscles-Medium, Systemic... Read more
Systemic: Dizziness / Lightheadness-Mild, Systemic: clenched fists----rigid muscles-Medium, Systemic: Shakiness-Mild, Additional Details: pt has anxiety w/ needles---possible panic attack
22 2021-06-21 seizure Had a seizure 2 days after vaccine. Also said he had used cocaine, lack of sleep and graduated last ... Read more
Had a seizure 2 days after vaccine. Also said he had used cocaine, lack of sleep and graduated last weekend
22 2021-06-22 unresponsive to stimuli Patient was fine until about 5 minutes post immunization, when he fainted. He was unresponsive for ... Read more
Patient was fine until about 5 minutes post immunization, when he fainted. He was unresponsive for about 8 minutes. We wet his face with some water, laid him down on floor with feet up on chair, checked pulse, called 911. They checked vitals and after he was awake he made the decision to not go to hospital. Patient left with parents to go to their doctor.
22 2021-06-30 tremor The adverse reaction is an ongoing effect from the injection shot's placement (left arm/shoulder) an... Read more
The adverse reaction is an ongoing effect from the injection shot's placement (left arm/shoulder) and down to the end of my left hand which is best described as an undesired tremor. ~ arm and hands have a feeling since the shot acting as relentless shaking in relative location to shot. Happens multiple times a week, sometimes all throughout the day. Unclear triggers.
22 2021-07-01 grand mal seizure Witnessed Tonic Clonic seizure lasting 30 seconds
22 2021-07-02 pain in extremity Mentioned wanting to kill himself; three voices in his head; Completely lost, he would not know who ... Read more
Mentioned wanting to kill himself; three voices in his head; Completely lost, he would not know who he was, where he was; Chest pain; Stomach pain; Hand pain/feet pain; Shaky feelings; Knee pain; Body ache; This spontaneous case was reported by a consumer and describes the occurrence of SUICIDAL IDEATION (Mentioned wanting to kill himself) and HALLUCINATION, AUDITORY (three voices in his head) in a 23-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 040B21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below. Concurrent medical conditions included Hydrocephalus, Down's syndrome and Convulsions. Concomitant products included OXCARBAZEPINE (OXCARBAZEPIN) for an unknown indication. On 12-Apr-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 12-Apr-2021, the patient experienced SUICIDAL IDEATION (Mentioned wanting to kill himself) (seriousness criterion medically significant), HALLUCINATION, AUDITORY (three voices in his head) (seriousness criterion medically significant), FEELING ABNORMAL (Completely lost, he would not know who he was, where he was), CHEST PAIN (Chest pain), ABDOMINAL PAIN UPPER (Stomach pain), PAIN IN EXTREMITY (Hand pain/feet pain), NERVOUSNESS (Shaky feelings), ARTHRALGIA (Knee pain) and MYALGIA (Body ache). The patient was treated with IBUPROFEN (MOTRIN [IBUPROFEN]) for Pain, at an unspecified dose and frequency and PARACETAMOL (TYLENOL) for Pain, at an unspecified dose and frequency. At the time of the report, SUICIDAL IDEATION (Mentioned wanting to kill himself), HALLUCINATION, AUDITORY (three voices in his head), FEELING ABNORMAL (Completely lost, he would not know who he was, where he was), CHEST PAIN (Chest pain), ABDOMINAL PAIN UPPER (Stomach pain), PAIN IN EXTREMITY (Hand pain/feet pain), NERVOUSNESS (Shaky feelings), ARTHRALGIA (Knee pain) and MYALGIA (Body ache) outcome was unknown. DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): In 2021, Scan brain: normal (normal) normal. Patient prescribed anxiety and sleeping pills that the physician did not recommend that he take. Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded. Unlikely, that the events are related to the vaccine due to existing comorbidities. This case was linked to MOD-2021-235268 (Patient Link).; Sender's Comments: Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded. Unlikely, that the events are related to the vaccine due to existing comorbidities.
22 2021-07-05 hot flush, muscle spasms Digestive pains and issues, hot and cold flashes, muscle spasms. I didn?t even want to get this vacc... Read more
Digestive pains and issues, hot and cold flashes, muscle spasms. I didn?t even want to get this vaccine but my school requires it. I?m sure this will get chalked up to a coincidence when in fact every doctor and pharmacist that is misrepresenting the pros/cons of this vaccine should be held criminally and civilly liable. I?m a healthy 23 year old who had covid 4 months ago. It was easier than the flu. There?s no reason why it should be suggested let alone required to get this vaccine without proper informed consent. It?s my body my choice until the government can wield some power and it?s trust the science until the science doesn?t support a political narrative
22 2021-07-06 numbness I was sitting calmly as weekend classes were ending. I experienced a rapid heart rate followed by ... Read more
I was sitting calmly as weekend classes were ending. I experienced a rapid heart rate followed by numbness in hands, legs and eventually face. I couldn't walk or breathe. I was transported to the hospital by ambulance and was told by the paramedics that I was having a panic attack.
22 2021-07-07 tingling, numbness ON jULY2ND-jULY 4TH FEVER, CHILLS, NAUSEA, VOMITING, BODY ACHES,. OVER THE NEXT FEW DAYS HE DEVELOPE... Read more
ON jULY2ND-jULY 4TH FEVER, CHILLS, NAUSEA, VOMITING, BODY ACHES,. OVER THE NEXT FEW DAYS HE DEVELOPED CHEST PAIN, PALPITATIONS. CHEST PAIN WITH DEEP BREATH., LEFT HAND AND ARM WITH NUMBNESS, TINGLING
22 2021-07-10 cold sweat patient got light headed and cold and clammy
22 2021-07-11 cold sweat, tremor, flushing Systemic: Chills-Mild, Systemic: Dizziness / Lightheadness-Medium, Systemic: Flushed / Sweating-Medi... Read more
Systemic: Chills-Mild, Systemic: Dizziness / Lightheadness-Medium, Systemic: Flushed / Sweating-Medium, Systemic: Hypertension-Mild, Systemic: Shakiness-Mild, Additional Details: He felt lightheaded, tried to stand up and get the pharmacy staff's attention, then fell. He said he doesnt remember the fall. The pharmacy staff helped him to sit up and he asked for water. He felt sweaty and clammy, asked the pharmacist to hold his hands. The LVN came over to check on him and started taking his BP, he then felt nauseated and threw up. The pharmacy called 911, the EMT came and every thing checked out normal. The LVN called his family and he is resting in the LVN's room.
22 2021-07-11 face paralysis, bell's palsy, pain in extremity, tingling At the end of April my left foot begun having arthrisit like pain. My foot was and still is tingly a... Read more
At the end of April my left foot begun having arthrisit like pain. My foot was and still is tingly and I experience sharp shooting pains in my foot. After this began I was diagnosed with Bells Paulsy on May 3rd after I noticed on May 1st the left side of my face was weak and I could not blink my left eye.
22 2021-07-15 weakness Pt.'s grandmother states that after receiving the 2nd dose of Moderna 06/16/2021, started experienci... Read more
Pt.'s grandmother states that after receiving the 2nd dose of Moderna 06/16/2021, started experiencing with extreme weight lost and slight cough. Primary visit (Blood work, X-rays, Chest X-ray) showing Thyroid levels elevated. Specialist seen 06/29/2021, Ultrasound continuing current medications. Follow-Up visit scheduled for 07/16/2021. Still experiencing extreme light-headness, weakness, loss of appetite.
22 2021-07-15 numbness, pain in extremity, cold sweat 1st Shot(5/3/21): Soreness in arm, Fatique 2nd shot(5/31/21): Soreness in arm, Fatique, headaches, ... Read more
1st Shot(5/3/21): Soreness in arm, Fatique 2nd shot(5/31/21): Soreness in arm, Fatique, headaches, developed a cough a week later which lasted about a week. Adverse event (7/6/21): Started coughing and spitting blood around 5:00pm. Coughing persisted throughout the evening. At 6:00am I told my mom I was having a problem. around 6:30am my body went numb, loud ringing in my ears, and broke out into a cold sweat, so we called 911. The paramedics arrived and checked me out, and they believed I was okay. When they left we decided to go to the ER. Admitted on 7/7/21-7/12/21
22 2021-07-18 migraine Swollen arm for a constant 4 days migraine nausea fatigue increased heart rate and blood pressure.
22 2021-07-19 nerve pain, tingling Since getting the vaccine, I have developed multiple strange health conditions. The first is that I ... Read more
Since getting the vaccine, I have developed multiple strange health conditions. The first is that I have been nauseous and usually vomiting every day for at least the past 2 to 3 months. Also since getting the vaccine I have developed nerve pain and paresthesia in my hands that does not get better with rest and that I am now being treated for because it is so bad that I cannot work on my computer anymore. I also can no longer eat gluten without severe gastrointestinal distress, despite the fact that I have never had issues with gluten in the past. Finally, I have also developed two strange growths on both of my feet in the same spot on both feet. My primary care doctor thinks that they are ganglion cysts and are benign, but I thought it strange that I would develop the same thing on both of my feet in the same spot at the same time.
22 2021-07-21 muscle twitching PATIENT FAINTED AND HAD SLIGHT LEFT ARM/LEG TWITCHING 5 MINUTES AFTER ADMINISTERING VACCINE
22 2021-07-23 tingling, numbness Patient received second Moderna vaccine at vaccine event. He had reported some post vaccine tinglin... Read more
Patient received second Moderna vaccine at vaccine event. He had reported some post vaccine tingling with first vaccine, so he was triaged after second vaccine to the 30 minute observation area. He again complained of left sided tingling and also subjective numbness of face and tongue. His exam was normal. Normal cranial nerve function. Normal speech. Normal VS. No meds administered. Given some snacks. Symptoms resolved over course of another 30 minutes. Discharged to home without incident
23 2021-01-05 pain in extremity Sore arm, body aches, and nausea
23 2021-01-05 tingling, pain in extremity Approximately 6 minutes after receiving vaccine, patient experiencing left arm was feeling heavy. P... Read more
Approximately 6 minutes after receiving vaccine, patient experiencing left arm was feeling heavy. Patient felt like the arm was feeling "weak". May have had some tingling in the fingers. Initial BP 137/72 HR 95 O2=97%. Heaviness in the arm dissipating after 20 minutes. At 25 minutes, patient starting feeling a dull pain in forearm ascending to the left side of the neck with some intensity, but subsiding to a very dull pain. Tingling in the fingers subsided, but very mild at 30 minutes. At 5:35pm, BP 147/75 HR 91 O2=98%. At 5:45pm patient reports some mild tingling in fingers. Pain in the neck area and arms feel more like a stiffness than pain. Patient released from clinic at 5:50pm.
23 2021-01-06 tingling Approximately 10 minutes after receiving vaccine patient began to experience some mild discomfort on... Read more
Approximately 10 minutes after receiving vaccine patient began to experience some mild discomfort on the left neck (mild "stiff neck"), heavy arm or discomfort, and mild tingling in the fingers. Initial BP 149/92 HR 91. Patient clinically stable at 30 minutes post-vaccination. Neck pain gone 30 minutes post-vaccination; patient only feels pain at injection site. BP 143/95 HR 86 O2=98%. Patient released from clinic at 2:22pm.
23 2021-01-06 tension headache Early on in the day of 1/6/21, I felt very sluggish and spaced. My boss asked me early in the day if... Read more
Early on in the day of 1/6/21, I felt very sluggish and spaced. My boss asked me early in the day if I was okay because she said that I seemed "out of it." It wasn't to the point that I was unable to work, but it was a noticeable difference from my typical state. At 11:31 AM, I texted my wife and said "I feel gross and weird today." When she asked me how so, I replied, "I just feel run down, my neck hurts, and I can't focus." My arm was more sore than it typically is from the flu shot, but it wasn't unbearable. As the day went on, I felt the cloudiness in my head start to dissipate a bit and I started to feel a little better. By dinnertime, I was feeling sick to my stomach and was not able to eat very much. I chose to head to bed around 9 because I was feeling pretty ill (my neck had really started feeling sore again and my stomach was very upset.) At 1:30 AM on 1/8/21, I woke up with a horrible headache. I get migraines from time to time, but this was unlike anything I had ever felt before. It felt like my head was in a vise and I was very close to asking my wife to take me to the ER. I never go to the doctor, but it legitimately scared me. My neck was extremely sore and my head hurt so bad that even laying it on a pillow hurt. I was extremely nauseous as well. I took a few extra strength Tylenol and laid my neck on a heating pad with an ice back on my forehead. The sound of our humidifier was too much for me, so I also out in earplugs. After an hour or so, I fell back asleep. When I woke up this morning, I still had a headache and I took an Excedrin. To this point, I have felt a little sick to my stomach, but the intense headache has been kept at bay. My neck is still sore but it is also somewhat better.
23 2021-01-07 weakness Day of injection: weakness and site pain Next day: Fever, skin hot but shivering cold (chills), head... Read more
Day of injection: weakness and site pain Next day: Fever, skin hot but shivering cold (chills), headache, body aches Day 2: same as next day but less severe
23 2021-01-10 cold sweat Near-fainting, Lightheaded, chest tightness cold sweat
23 2021-01-10 migraine Patient reports receiving Moderna vaccine 6 days ago. Felt fine for first 30 minutes following vacci... Read more
Patient reports receiving Moderna vaccine 6 days ago. Felt fine for first 30 minutes following vaccine, but developed migraine headache next day, which resolved after 24 hours. Reports developing pruritic urticarial rash and swelling to hands and feet yesterday. Denies facial or mouth swelling. No chest tightness, wheezing or SOB. Denies previous reaction to vaccines. NKDA. Took benadyl yesterday and today, which did help. Assessment and Plan: 1. Urticaria - Possible correlation to Moderna COVID-19 vaccine received 6 days ago. Will treat with antihistamines and topical steroid cream. Avoiding systemic steroids, as do not want to suppress immune response to recent COVID-19 vaccine. - Treatment with antihistamine- Benadryl OTC and Claritin. - Provided patient with V-safe smartphone tool info to report potential side effects of COVID-19 vaccine. - Completed VAERS report for potential reaction. - Advised employee patient also follow-up with occupational health regarding plans for second vaccine dose. - Follow up at ED if facial swelling, SOB or if symptoms worsen. - Will route chart to PCP. - TRIAMCINOLONE ACETONIDE 0.1 % TOPICAL CREAM APRN.CNP  
23 2021-01-10 pain in extremity Extreme arm soreness and swollen lymph nodes in the opposite arm
23 2021-01-14 feeling hot Shortness of breath, Chest tightness, and Hot
23 2021-01-16 tremor, weakness Onset @ 1:00 am 01/17/21: Nausea, Dizziness, Tremors, Chills, Headache, and weakness
23 2021-01-20 tingling Moderna COVID- 19 Vaccine EUA- Patient reported having a headache and tingling in all fingers that s... Read more
Moderna COVID- 19 Vaccine EUA- Patient reported having a headache and tingling in all fingers that started 15 minutes after getting his vaccine. Patient was given 4.5 mg of Benadryl PO . Patient's symptoms resolved within 5 minutes of taking the Benadryl.
23 2021-01-20 tenderness, tremor, pain in extremity Arm Pain, Tenderness upon moving/touching. 2-3 hour onset after vaccination and continuous Severe C... Read more
Arm Pain, Tenderness upon moving/touching. 2-3 hour onset after vaccination and continuous Severe Chills around 1:00am (l15 hours post injection) -- > uncontrollable shaking and tensing of almost all extremity (arms,legs, neck, and back) muscles. Sudden onset, lasted for 20mins
23 2021-01-21 pain in extremity, weakness I had no strength in my left arm as well as severe soreness. I also had fatigue, body aches and chil... Read more
I had no strength in my left arm as well as severe soreness. I also had fatigue, body aches and chills and a 103 fever
23 2021-01-26 migraine, pain in extremity, night sweats 8pm: Headache, pain at injection site 3am: Woke up with extreme chills, severe night sweats and fev... Read more
8pm: Headache, pain at injection site 3am: Woke up with extreme chills, severe night sweats and fever of 10.5 7am: Chills, fever, severe pain when moving arm at injection site 9am: Chills subsided, severe migraine, and fatigue, low grade fever 3pm: All symptoms subsided except for pain at injection site and headache
23 2021-01-28 migraine Soreness in arm at injection sight. Muscular pain and general fogginess of thinking for the next 24 ... Read more
Soreness in arm at injection sight. Muscular pain and general fogginess of thinking for the next 24 hours with intermittent migraines.
23 2021-01-29 pain in extremity After 8 days of receiving the vaccine, on Jan 28th at 8am, I developed a dizziness that stayed the w... Read more
After 8 days of receiving the vaccine, on Jan 28th at 8am, I developed a dizziness that stayed the whole day with me. On Jan 29th, I still have the dizziness and at 1pm on Jan 29th, I developed a new soreness in my left arm where the shot was taken. I have soreness in my left arm and dizziness still and it is currently 10:55pm CST on Jan 29th.
23 2021-02-01 tingling, numbness, feeling cold Coldness/ tingling/ numbness sensation on entire left side of gastrocnemius. Can still flex/ stretch... Read more
Coldness/ tingling/ numbness sensation on entire left side of gastrocnemius. Can still flex/ stretch/ walk. No signs of rash
23 2021-02-03 tingling Patient had vasovagal type reaction at 1:59 PM . Appeared pale, felt faint and complained of faci... Read more
Patient had vasovagal type reaction at 1:59 PM . Appeared pale, felt faint and complained of facial tingling . BP was 164/81 P 102 . Rechecked after 10 minutes. BP 134/84 and P 81. Symptoms resolved after 20 minutes and patient left . Writer attempted contact with client later that day and left messages on 1/29/21 and 1/30/21 . Spoke with patient on 2/2/21 and he reported no further symptoms.
23 2021-02-04 weakness Woke up with a headache and fatigue, as well as soreness near area of injection. Energy was very low... Read more
Woke up with a headache and fatigue, as well as soreness near area of injection. Energy was very low and felt very tired. Tried to sleep at around 12:00 PM but had a thumping in my head that would not let me fall asleep. Around 3:00 PM tried to sleep again but being shivering/shaking a lot despite being under a blanket and comforter. Eventually needed to take a hot bath for around 45 minutes to an hour. Took my temperature while in the bath which read 96°F (although that thermometer may not be the most accurate.) After the bath I went directly to bed with a comforter, blanket and weighted blanket and was able to fall asleep for about 90 minutes. Was no longer shivering when I awoke and felt much better. Went to sleep at around 9:00 PM and felt fine when I woke up the next morning.
23 2021-02-04 hot flush 17:53: injection administered. 17:03: reported adverse events--hot flashes and sweating. pt refuse... Read more
17:53: injection administered. 17:03: reported adverse events--hot flashes and sweating. pt refused epinephrine. 17:08 adverse effect continue. epinephrine given. Paramedic called. 61/58 with machine, manually --80/42: elevated legs. about 17:15 Paramedics arrived: b/p 91/60. pt states that he was getting better. sweating resolving. 5:22 discharged to the paramedics.
23 2021-02-05 pain in extremity Sore arm, Felt relaxed
23 2021-02-05 pain in extremity Full body chills, body aches, headache, sore arm. No fever. Drowsiness. Symptoms lasted approximatel... Read more
Full body chills, body aches, headache, sore arm. No fever. Drowsiness. Symptoms lasted approximately 24 hours, from 7am on Feb 3rd to sometime in the early morning of Feb 4th. I took a total of 2000mg acetaminophen and 800mg ibuprofen throughout the day to relieve aches.
23 2021-02-08 pain in extremity Arm pain, fever, severe chills, headache, malaise, joint pain, general muscle pain, fatigue
23 2021-02-08 tension headache Moderna COVID-19 Vaccine Moderate to severe chills, fatigue, myalgias, and headache. Moderate to se... Read more
Moderna COVID-19 Vaccine Moderate to severe chills, fatigue, myalgias, and headache. Moderate to severe tension like pulling in posterior neck and posterior head. NyQuil and Advil therapy.
23 2021-02-09 weakness On 2/7/2021 at 3:00 am he started with fever of 99 then went up to 102.9. He reports he had chills,... Read more
On 2/7/2021 at 3:00 am he started with fever of 99 then went up to 102.9. He reports he had chills, weakness, body aches, and an elevated blood pressure. He went to MC. Blood was performed but results unknown. He was diagnosed with a vaccine reaction. He was given Tylenol while in the ER. He was told to continue taking antipyretics. HE was discharged from the hospital and will have to follow up with PCP concerning elevated blood pressure.
23 2021-02-11 night sweats Moderna COVID-19 VACCINE Fever, chills, cough, sweating overnight and then loss of taste and smell ... Read more
Moderna COVID-19 VACCINE Fever, chills, cough, sweating overnight and then loss of taste and smell the next morning. Soreness at the site of the injection. Extremely fatigued. Tmax 100.5 Bodyaches, Headaches , Nasal congestion, Shortness of Breath, Chest Pain. Four days after 2nd Moderna vaccination his loss of taste and smell is still affected. His left arm soreness still persists. Bodyaches and fatigue still persists. Headaches comes and go. Nasal congestion persists Resolved Shortness of breath,Chest Pain, Fever and cough
23 2021-02-18 seizure Seizure-like episodes. No treatment at this time.
23 2021-02-20 feeling cold, feeling hot The night I received the second dose, I was unable to sleep and had developed a fever. The next day ... Read more
The night I received the second dose, I was unable to sleep and had developed a fever. The next day I had the worst headache of my life and my body kept switching between feeling hot and cold. That night, I was able to sleep, but I woke up drenched in sweat. Day two after vaccination, I had a mild headache.
23 2021-03-03 cold sweat symptoms: cold sweats, headache, dizziness, light-headed, chills, body aches, drowsiness time course... Read more
symptoms: cold sweats, headache, dizziness, light-headed, chills, body aches, drowsiness time course: 24 hrs.
23 2021-03-03 pain in extremity Nothing at time of injection. In the evening, soreness in the arm (strong but on par for what I woul... Read more
Nothing at time of injection. In the evening, soreness in the arm (strong but on par for what I would expect). Next morning, I starting feeling sick, with flu symptoms. Aching muscles, sensitive skin, mild headache, sore eyes, and in the evening, nausea. Temperature gradually rose. ~99.7 at 6pm, 100.1 at 7pm, 100.7 at 8pm, 101.7 at 9:30pm. I took some Tylenol around 7pm, and then some theraflu at 10pm. Fell asleep at 11pm. Periodically waking up every 30min from 1am onwards. Muscle discomfort, sweating, and nausea continued until 3:45 AM, at which point I was feeling better and was able to sleep continuously. Feeling much better in the morning on March 4th. Temperature was 99.9, then rose to 100.0 at 11am. Now, at 3pm, feeling fatigue, exhaustion. No headache. Normal sense of taste and smell. No couch. Taking another day off from work. Temperature is currently 100.0. Taking more theraflu now, have not taken Tylenol today.
23 2021-03-04 cold sweat, depressed level of consciousness Became diaphoretic, pale, clammy, faint B/P 111/71, HR= 50 Stated feeling dizzy, ringing in ears, u... Read more
Became diaphoretic, pale, clammy, faint B/P 111/71, HR= 50 Stated feeling dizzy, ringing in ears, unable to remain alert/focused. LOC intermittently for several seconds for about 10 minutes total time
23 2021-03-04 tremor Patient received a COVID-19 vaccine on 04MAR21 @ 1400. At 1645, he returned to the vaccine room sha... Read more
Patient received a COVID-19 vaccine on 04MAR21 @ 1400. At 1645, he returned to the vaccine room shaking and his eyes were tearing up. He complained of pain at the injection site, headache, nausea, abdominal pain, chills and joint pain. His temperature was 98.4 @ 1712. He also complained of increased saliva production. He laid down on a cot and an emergency rescue blanket was applied. He was reassured and monitored by our onsite RN. He was stable and left at 1755.
23 2021-03-05 pain in extremity ~2 hours after vaccination, around 1:30 PM on March 5, strong pain and soreness in the left arm star... Read more
~2 hours after vaccination, around 1:30 PM on March 5, strong pain and soreness in the left arm started. Later at around 6:30 PM I took an Advil tablet for the pain. At around 7:30 PM I took a second one since the pain was still strong after the first one. I took a third Advil tablet at around 11:30 PM. At around 12:30 AM on March 6, while going to sleep, fever-like symptoms started such as high body temperature, chills, congestion and aches. Fever symptoms continued as I intermittently woke up around 6-8:00 AM, and as I woke up again around 9:50 AM the feverish side effects had mostly subsided. Arm soreness has also decreased dramatically but is still present.
23 2021-03-06 pain in extremity Symptoms: High levels of pain in the arm that received the vaccination, runny nose, stuffy nose, hea... Read more
Symptoms: High levels of pain in the arm that received the vaccination, runny nose, stuffy nose, headache the morning following the vaccination, high fever (102-103) the night of the vaccination, and nausea the day after the vaccination.
23 2021-03-06 seizure like phenomena While technician finished administering the vaccine , patient had seizure like reaction that lasted ... Read more
While technician finished administering the vaccine , patient had seizure like reaction that lasted for about 15 seconds . Patient immediately gained consciousness and had no recollection of what happened. He waited for 30 minutes and totally fine. Prior to giving the shot, patient checked the box for feeling dizzy after vaccinations, when I inquired about it , he said that was years back and he had no issues with any vaccines that he has taken. He take flu vaccine every year.
23 2021-03-07 pain in extremity High Fever, Severe arm pain, joint and muscle aches, altered cognition (strange thoughts).
23 2021-03-08 pain in extremity, grand mal seizure, hot flush First vaccine on 1/26/21 began taking three naps a day and arm pain. Given Ibuprofen. Seemed to reso... Read more
First vaccine on 1/26/21 began taking three naps a day and arm pain. Given Ibuprofen. Seemed to resolve after 5 days, but continued to nap three times a day sometimes. No fever, but hot flashes at times. Booster given 2/23/21. Began to nap again three times a day or want to stay in his dark room. Began to have a lot of sinus drainage. Gagging at times. Pain over right eye area. Pain in right flank and stomach area. Severe headaches and possible body aches. No fever, but increased and more severe hot flashes that would wake him. 2/28 had a tonic clonic seizure after presenting with a distressed look throughout the day. Slept and upon waking began vomiting until 3am. Was at the ER and given many tests, pain meds and nausea meds. Ruled out kidney stones with CT scan and urinalysis. No fever, but hot flashing continued. ER visit lasted from 2/28/21 through 3/1/21 ER Physician suspects possible reaction to vaccine. Followed up with Neurologist and General Practitioner and both suspect reaction to vaccine.
23 2021-03-11 pain in extremity Light-headedness and fatigue day after vaccine, pain in left arm immediately following vaccine
23 2021-03-14 pain in extremity, night sweats A couple of hours after my fist dose Moderna vaccine, my left arm began to hurt, I also developed he... Read more
A couple of hours after my fist dose Moderna vaccine, my left arm began to hurt, I also developed headaches, body aches and left arm swelling. At 1am-2am, I could not move my left arm and my fever was 103.3F. I contacted urgent care who told me to take Ibuprofen as pain medication. My symptoms did decrease although I still have today difficulty sleeping and sweat at night which I did not have before the vaccine.
23 2021-03-15 weakness 1/19 began vomiting and was hospitalized. On 1/30 he was discharged and later received the vaccine. ... Read more
1/19 began vomiting and was hospitalized. On 1/30 he was discharged and later received the vaccine. It begins with weakness and a lack of appetite. He started coughing up foul-smelling secretions. He makes the arrangements to take him to the emergency room again, he called 911 to be transported, when they are taking the information from the POC, he is under oxygenation to 44. They take him in the ambulance, he receives CPR, they transport him to the facility where he arrives lifeless.
23 2021-03-15 tingling patient received 1st dose of Moderna Covid 19 shot around 3pm on 3-15-21 and did not feel well right... Read more
patient received 1st dose of Moderna Covid 19 shot around 3pm on 3-15-21 and did not feel well right after. patient sat in the rx waiting room chair and asked for help. RPH went out and patient said he felt very very dizzy and that his whole body tingled. Patient stated this has never happened before. patient was given water and proceeded to shortly lose consciousness. Ambulance was called and they fully checked him out and said all vitals were fine and that patient could leave whenever he felt OK to do so. Patient ended up sticking around in pharmacy waiting area for around 1 hour in total and then left around 4pm, stating he felt much better and was fine to drive home.
23 2021-03-23 pain in extremity, tingling Patient (nursing home employee) was given his second dose of the Covid 19 vaccine today (March 24,20... Read more
Patient (nursing home employee) was given his second dose of the Covid 19 vaccine today (March 24,2021) during a routine nursing home vaccination clinic. Patient was given his second dose at 8:35 am and at 8:39 am he was complaining of shortness of breath, chest pain, as we as pain in his extremities. Patient stooped in chair and lowered to the ground. Epi Pen 0.3 mg was administered by the attending pharmacist, at 8:41 am and the ambulance was called. HIs vital signs were taken: Blood pressure 123/77, Oxygen 99%, pulse ranged from 104 to 111 bpm. Patient complained of pins/needles feeling in extremities, his arms (both left and right) were contracting, and his pupils were dilated. He was given 4 L oxygen, and the ambulance arrived at 8:58 am.
23 2021-03-23 seizure 5 minutes after shot, pt slid from chair and fell backward; witness said pt suffered from mild seizu... Read more
5 minutes after shot, pt slid from chair and fell backward; witness said pt suffered from mild seizure; paramedics were called and pt was assessed; pt has no history of epilepsy but did have a fainting episode years ago when giving blood; he also stated he hasn't eaten or drank anything today; he declined transport to hospital but is getting a parent to pick him up; paramedics highly suggested that parent take him to the ER or urgent care
23 2021-03-24 tingling Patient received his first dose of Moderna COVID vaccine at 17:51 and reported at 18:04 that he had ... Read more
Patient received his first dose of Moderna COVID vaccine at 17:51 and reported at 18:04 that he had a tingling feeling go down his arms to his fingers, then felt light-headed and dizzy. Nurse noted he appeared pale and diaphoretic and took vital signs at 18:07 BP-105/50, P-85, R-18, O2-99%; 18:13 BP-124/59, P-63, R-18, O2-99%; 18:20 BP-142/62, P-81, R-16; 18:30 BP-137/85, P-81, O2-99%. At that time he reported feeling much better and was able to leave the vaccine clinic. RN did suggest f/u with Primary care provider about symptoms
23 2021-03-24 seizure Approximately 10 minutes after vaccination, patient experienced a seizure. EMS was on site and tende... Read more
Approximately 10 minutes after vaccination, patient experienced a seizure. EMS was on site and tended to pt immediately. Seizure subsided quickly. Per EMS, patient's blood sugar was "low" and BP was also "low". Ambulance was called. Within a few minutes, patient was awake and able to converse, Was taken to the ED by stretcher.
23 2021-03-28 tingling Chest tightness, throat closure, difficulty breathing, noise tingling.
23 2021-03-31 migraine Faint; Migraine; Dizzy; Disoriented; Joint pain; Fatigue; Muscle pain; Nausea; Slight fever; A spont... Read more
Faint; Migraine; Dizzy; Disoriented; Joint pain; Fatigue; Muscle pain; Nausea; Slight fever; A spontaneous report was received from a consumer concerning a 23 year old, male patient, who experienced faint (syncope), migraine, dizziness, fatigue, disoriented (disorientation), joint pain (arthralgia), muscle pain (myalgia), nausea, and slight fever (pyrexia). The patient's medical history was not provided. Concomitant products known to have been used by the patient, within two weeks prior to the events, included allergy medication unspecified. On unspecified date, the patient received their first of two planned doses of mRNA-1273 for prophylaxis of COVID-19 infection. On 10-FEB-2021, the patient received their second of two planned doses of mRNA-1273 (Lot number: 013L20A) intramuscularly in the left arm for prophylaxis of COVID-19 infection. On 10-FEB-2021, after vaccination, the patient experienced faint, migraine, dizzy, fatigue, disoriented, joint pain, muscle pain, nausea and slight fever. Treatment for the event included Ibuprofen and Excedrin. 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 event of faint was considered recovered. The outcome for the events of migraine, dizziness, fatigue, disoriented (disorientation), joint pain (arthralgia), muscle pain (myalgia), nausea, and slight fever (pyrexia) was considered unknown.; Reporter's Comments: Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded.
23 2021-03-31 pain in extremity I received the first shot of the Moderna Vaccine at approximately 8am on April 1st, 2021. I had no s... Read more
I received the first shot of the Moderna Vaccine at approximately 8am on April 1st, 2021. I had no symptoms or side effects immediately except slight fatigue and a sore arm. I went to bed around 8:30 PM and woke up roughly an hour later with horrible body chills and probable Fever. I have been sitting covered in multiple blankets shivering and unable to sleep.
23 2021-04-01 flushing Systemic: Dizziness / Lightheadness-Severe, Systemic: Hypotension (BP 88/73, HR 91), Amnesia? Did no... Read more
Systemic: Dizziness / Lightheadness-Severe, Systemic: Hypotension (BP 88/73, HR 91), Amnesia? Did not remember what occured.-Severe, Systemic: Flushed / Sweating-Severe, Additional Details: Pt was layed on floor and feet elevated. BP during incident was 88/73, HR was 91. Pt recovered briefly after, but did not remember what happened.
23 2021-04-01 muscle spasms, tremor 104f fever max, Fever >100f for 2 days. Shaking, Muscle spasms.
23 2021-04-03 flushing Systemic: Dizziness / Lightheadness-Mild, Systemic: Flushed / Sweating-Mild
23 2021-04-04 pain in extremity Severe arm pain at and around injection site. Fever and chills throughout day after vaccine (about 1... Read more
Severe arm pain at and around injection site. Fever and chills throughout day after vaccine (about 18 hours until symptoms calmed). Drowsiness. Headache. Itch at and around injection site, No treatment.
23 2021-04-06 feeling hot, flushing Patient informed the pharmacist that he had needle phobia. He was doing fine during the immunization... Read more
Patient informed the pharmacist that he had needle phobia. He was doing fine during the immunization but fainted 2 minutes after. his face turn red and feel heated. He was moved to the floor for better support with his feet elevated. Pharmacist accessed his breathing and applied cold compresses to the neck. offered cold water to drink. Patient rested in the room for about 15 minutes and returned normal and left pharmacy.
23 2021-04-06 flushing, feeling hot, cold sweat Patient was flushed, felt warm/clammy and had a headache
23 2021-04-06 seizure, feeling hot About a minute after the vaccination, the patient's head fell to the side, and he was unconscious. H... Read more
About a minute after the vaccination, the patient's head fell to the side, and he was unconscious. He seized for less than 1 minute. He was placed on the floor at which point he regained consciousness. He felt warm all over his body and fatigued. About 30 minutes later, he was still fatigued, and when he went to stand, he felt lightheaded again. He was taken to the hospital in an ambulance.
23 2021-04-07 hot flush 5 minutes after the shot, I began experiencing severe hot flashes, sweating, paleness, and vasovagal... Read more
5 minutes after the shot, I began experiencing severe hot flashes, sweating, paleness, and vasovagal syncope. This continued for 10-15 minutes while the fire department and physician on site checked my vitals. After being laid down at roughly 10 minutes after the shot, I began to regain consciousness. An ambulance was called, but was not needed.
23 2021-04-08 feeling cold Patient had syncope symptoms and gave ice pack and asked him to put his head between his legs to hel... Read more
Patient had syncope symptoms and gave ice pack and asked him to put his head between his legs to help with the dizziness, took BP and was normal and found out he was pre-diabetic so I gave a coke in case it was low sugar, he felt better 30-45 mins post-vaccine and returned to work, he came back after 5 minutes feeling cold and spinning, so we called EMS and asked him to lay down with feet elevated and covered him to try to keep him warm. EMS arrived and conversed with patient, took vitals, and recommended him to go home and rest as he was finally feeling better; overall, it took roughly 3 hours for symptoms to completely fade.
23 2021-04-08 feeling hot pt started feeling nauseous/hot/sweaty in the after in waiting area and signaled, bench pharmacist m... Read more
pt started feeling nauseous/hot/sweaty in the after in waiting area and signaled, bench pharmacist made it to chair and guided him to floor, pt was alert and did not hit head. may have lost consciousness for a few seconds while on the floor. elevated his feet with chair. pt opened eyes and we chatted and did breathing exercises. pt states history of fainting w/ IVs and IMZs in the past. declined offer to call someone for him, stated his people were too far away. called emergency medical and they responded, and checked him over. did not check back in with pharmacy, but emergency medical released him and walked out with him.
23 2021-04-08 muscle spasms Painful chills and muscle cramps. High-grade fever (101.5 degrees). Muscle aches. Fatigue and headac... Read more
Painful chills and muscle cramps. High-grade fever (101.5 degrees). Muscle aches. Fatigue and headache. All symptom appeared 11 hours after taking the first dose of the vaccine and are currently present.
23 2021-04-08 pain in extremity Severe soreness from the waist down, feeling like body aches as a flu symptom. Exhaustion. Felt plai... Read more
Severe soreness from the waist down, feeling like body aches as a flu symptom. Exhaustion. Felt plain crappy. Left work early (20 hours after vaccination) and slept most of the afternoon and night. Feel pretty much back to ?normal? this morning (42 hours after vaccination) No medication taken or doctor visit. Just rest.
23 2021-04-08 tingling, numbness Patient is reporting tingling/numb feet about 5-10 minutes after vaccination. After about 30 minutes... Read more
Patient is reporting tingling/numb feet about 5-10 minutes after vaccination. After about 30 minutes he said he was feeling fine, and walked around the store for a bit to make sure he was ok. Than he left.
23 2021-04-10 pain in extremity Sore left arm where shot was taken, Nausea, Headache, Symptoms lasted all Saturday.
23 2021-04-12 cold sweat The patient received his first Moderna vaccine on 4/8 at 9:45 am. At 9:55 the patient reported fee... Read more
The patient received his first Moderna vaccine on 4/8 at 9:45 am. At 9:55 the patient reported feeling a bit nauseous and like he "broke out in a cold sweat." Denied dizziness, lightheadedness, difficulties breathing or any other symptoms. Patient accepted to laydown and was provided water. Reported feeling better after that. VSS...BP 110/70 Pulse 65 Resp 16. Staff sat with the patient and his dad for an additional 10 minutes. Reviewed symptoms to watch for at home. Confirmed with the patient that he felt back to base line then allowed him to leave with his dad. On 4/13 a follow up call was made. Patient reports he has had no further symptoms and felt it was due to being nervous. I encourage him to inform his vaccinator when he comes in to get his second dose. Patient stated he appreciated the call and denied having any questions or concern.
23 2021-04-12 involuntary muscle movements Pt was observed to be slumped over in chair approximately 7min into waiting post vaccine in waiting... Read more
Pt was observed to be slumped over in chair approximately 7min into waiting post vaccine in waiting room. np alerted. Breathing , appeared to have fainted. Pt started to have jerking entire body movements as staff trying to get pt to wake up.... pt noted to have spit in mouth on lips and was making grunting noises as jerking . Staff assisted pt safely to floor. Epi retrieved but as came back to pt. And pharmacist also present w NP pt was breathing , slowly coming to , no swelling noted so then it became more clear poss vasovagal response ... in the beg it was unclear so Ems was activated . Pt continue to stay w clinic for an hour waiting on ride . Pt had declined Ems . Pt vitals pulse 55-65.... coloring better initially very pale . Mother came and reports that it gets nervous and has passed out before after blood draw but not a shot.
23 2021-04-12 electric shock sensation 4/6/21 Per, he felt two electrical pulses going to arm at the time he was vaccinated, noticed a chan... Read more
4/6/21 Per, he felt two electrical pulses going to arm at the time he was vaccinated, noticed a change in dexterity of thumb, forearm feels heavy, a little pulsating in thumb, not numb, "dropped something", can use arm and hand, saw PCP on 4/6/21 who thinks is inflammation of nerve and will resolve.
23 2021-04-12 feeling cold Patient fainted, Blood pressure of 90/50, heart rate 50, patient sweating, very sleepy, feeling col... Read more
Patient fainted, Blood pressure of 90/50, heart rate 50, patient sweating, very sleepy, feeling cold
23 2021-04-12 seizure Systemic: Chills-Severe, Systemic: Dizziness / Lightheadness-Severe, Systemic: Exhaustion / Lethargy... Read more
Systemic: Chills-Severe, Systemic: Dizziness / Lightheadness-Severe, Systemic: Exhaustion / Lethargy-Severe, Systemic: Fainting / Unresponsive-Severe, Systemic: Seizure-Severe
23 2021-04-12 tremor Patient had nausea, dizziness, shivering, trembling, and sweating, BP 101/51, HR76, RR12, T99.1. Sym... Read more
Patient had nausea, dizziness, shivering, trembling, and sweating, BP 101/51, HR76, RR12, T99.1. Symptoms did not resolve after 25 minutes, ED was called and patient taken to ED. Upon arrival to ED, was hyperventilating and had anxiety. ED BP 121/74 HR77 RR20, T98.2F. EKG normal. Monitored in ED, then discharged once stable.
23 2021-04-12 unresponsive to stimuli Systemic: Dizziness / Lightheadness-Severe, Systemic: Fainting / Unresponsive-Medium, Additional Det... Read more
Systemic: Dizziness / Lightheadness-Severe, Systemic: Fainting / Unresponsive-Medium, Additional Details: felt unwell, fell out of recovery chair and hit head. Patient monitored on floor with feet elevated until rescue came and took patient to ER and was monitored. Went home same day and returned to work the next day, feeling better
23 2021-04-12 unresponsive to stimuli Pt was noted to be sliding/falling our of chair to his right side. Patient appeared unresponsive. Pt... Read more
Pt was noted to be sliding/falling our of chair to his right side. Patient appeared unresponsive. Pt was hoisted down to the floor (by this RN) and placed in Trendelenburg position. Pt?s eyes were noted to be open with some snoring respiration sounds. Pt?s facemask was removed. Pt then became arousable, confused about circumstances, and what had happened. Pt reports he believe he fell asleep in the chair. Pt was able to ambulate out of the facility without assistance after an appropriate amount of time. Patients vital signs were recorded during the event.
23 2021-04-13 feeling hot PATIENT STATED HE WAS FEELING REALLY HOT AND DIZZY. PATIENT WAS HOT TO TOUCH. PATIENT THEN STATED H... Read more
PATIENT STATED HE WAS FEELING REALLY HOT AND DIZZY. PATIENT WAS HOT TO TOUCH. PATIENT THEN STATED HE WAS HAVING DIFFICULTY BREATHING. I HAD HIM LAY DOWN AND ELEVATED HIS FEET. KEPT TALKING TO HIM AND ASKED HIM IF HE FELT LIKE HIS BREATHING WAS GETTING WORSE AND HE SAID YES. I ASKED TO CALL 911 AND I ADMINISTERED ONE DOSE OF AN EPI PEN INTO HIS RIGHT THIGH. WITHIN 30 SECONDS I ASKED HIM HOW HE WAS FEELING AND HE SAID HE COULD BREATH BETTER, HIS SKIN STARTED FEELING COOLER TO THE TOUCH. PARAMEDICS ARRIVED AND TOOK HIM ON TO THE EMERGENCY ROOM.
23 2021-04-13 feeling hot Within 30 minutes of receiving the vaccine, the patient felt hot, was dizzy and fatigued. At 2238, ... Read more
Within 30 minutes of receiving the vaccine, the patient felt hot, was dizzy and fatigued. At 2238, the patient was given Benadryl 25 mg po. Patient went home at 2246.
23 2021-04-15 feeling hot, numbness, seizure On 4/15 at 1:50pm my injection arm started getting very itchy. I have a sore located 3 inches next t... Read more
On 4/15 at 1:50pm my injection arm started getting very itchy. I have a sore located 3 inches next to the injection site. Approximately 1 minute after it began to itch I got very hot and nauseous, approximately 30 seconds later I was unconscious and beginning to seize. I was unconscious for about 1 minute. When I awoke I couldn?t see anything, my entire body was numb and in pain. I couldn?t move my fingers. I was rushed to the ER but by the time I was seen I was fully coherent and fine.
23 2021-04-15 pain in extremity Arm slightly sore about 2 hours after injection. Only upper arm near injection site was sore for a l... Read more
Arm slightly sore about 2 hours after injection. Only upper arm near injection site was sore for a little over 48 hours. Headache and fatigue started about 9hours after injection. Continued symptoms lasted about 48 hours.
23 2021-04-15 tremor, seizure like phenomena Patient (002956225) - received Moderna vaccination (Lot # 0011A21A) on 04/16/2021 at 09:02 in the le... Read more
Patient (002956225) - received Moderna vaccination (Lot # 0011A21A) on 04/16/2021 at 09:02 in the left arm by RN. 0904 Patient began walking from the Vaccine station towards Observation. After approximately 20? feet, LPN in another vaccine station down the line, noticed the patient stumbling towards the wall. She observed him stumble/fall into the wall, hitting his head, then began falling to the floor. LPN came around her partition, called for help and was immediately assisted by LPN. The two nurses assisted the patient to the floor. They reported his eyes were fully dilated and he began having light, full-body shakes. The two nurses turned the patient on his side and held his head. Waters said the patient was able to answer all questions appropriately. The full body shakes lasted approximately 30 seconds. The Patient did not lose consciousness. 0905 Lead Nurse arrived noting the patient was lying on the floor in the prone position exhibiting mild seizure like activity and his pupils were dilated. Patient was rolled onto his side until the seizure like activity subsided, lasting for approximately 30 seconds. 0905 IC/PSC called 911, PD. The site Medical Protocols plan was activated. 0906 Vital signs were obtained: Blood pressure: 96/80, HR 78, 02 at 91% on room air. A neuro check was performed on the patient and he was noted to be alert and oriented x3. Patient stated he had not eaten anything prior to coming in. Patient was assisted to a seated position while still on the floor. Patient was given water, juice, a banana and other snacks. Nurses in the Observation Station noticed the incident from across the arena and brought the EpiPens, AED, Blood Pressure Cuff and med bag. 0910 Vital signs were obtained: BP 104/47, HR 50, 02 98% on room air and respirations 18. Patient remained fully alert and oriented but noted to have mild tremors of both hands. 0915 TFD, followed shortly by EMS, arrived on scene at and assumed care of the Patient. 0926 Patient decided to be transport to the Hospital and was removed from facility via stretcher.
23 2021-04-18 numbness Upon returning for second dose of Moderna vaccine, patient stated that his right hand and ring finge... Read more
Upon returning for second dose of Moderna vaccine, patient stated that his right hand and ring finger, specifically, had gradually started to feel numb over the past two weeks. Patient stated that it was not bothering him but that he would go to urgent care or visit his primary care, if the symptoms worsened or if he had further concerns about them.
23 2021-04-18 pain in extremity Fever and pain in arm.
23 2021-04-18 tingling Patient received COVID-19 vaccination (Moderna) at 12:04pm. He sat at the table for observation peri... Read more
Patient received COVID-19 vaccination (Moderna) at 12:04pm. He sat at the table for observation period ?stood up and turned, stated he was feeling nauseated, took a step forward and then fainted forward onto a different table. Staff responded and lowered him backward onto the floor. Vitals assessed ?BP 100/62, P 72, O2 SAT 98% on room air. Ice pack applied to forehead; patient sweaty but responding, stated hands tingled but no other complaint. Breathing regular, not labored. Admits he had a similar reaction to a vaccination about 3 years ago ?does not recall type of vaccine but agreed not life threatening reaction. Denied having any allergies that he is aware of. Admits he did not eat recently. Patient stated he did not hit his face when he fell onto the table, denied physical injury. Assisted to sit up while on floor for a while, then to stand and sit back onto a chair. Given bottle of water and granola bar. Orthostatic blood pressure checked at 12:25pm ?sitting blood pressure was 110/72 and standing 108/62. Patient stated feeling well; had him wait out a 30-minute observation period rather than 15-minute period. Walked out of building with staff and his sister; encouraged sister to drive them home, and for him to eat.
23 2021-04-18 tingling Patient received COVID-19 vaccination (Moderna) at 12:04pm. He sat at the table for observation peri... Read more
Patient received COVID-19 vaccination (Moderna) at 12:04pm. He sat at the table for observation period –stood up and turned, stated he was feeling nauseated, took a step forward and then fainted forward onto a different table. Staff responded and lowered him backward onto the floor. Vitals assessed –BP 100/62, P 72, O2 SAT 98% on room air. Ice pack applied to forehead; patient sweaty but responding, stated hands tingled but no other complaint. Breathing regular, not labored. Admits he had a similar reaction to a vaccination about 3 years ago –does not recall type of vaccine but agreed not life threatening reaction. Denied having any allergies that he is aware of. Admits did not eat recently. (to Continuation Page)Additional information for Item 18: Patient stated he did not hit his face when he fell onto the table, denied physical injury. Assisted to sit up while on floor for a while, then to stand and sit back onto a chair. Given bottle of water and granola bar. Orthostatic blood pressure checked at 12:25pm –sitting blood pressure was 110/72 and standing 108/62. Patient stated feeling well; had him wait out a 30-minute observation period rather than 15-minute period. Walked out of building with staff and his sister; encouraged sister to drive them home, and for him to eat.
23 2021-04-20 cold sweat, seizure Pt fainted, fell off his chair onto the floor where he was convulsing. He then regained consciousnes... Read more
Pt fainted, fell off his chair onto the floor where he was convulsing. He then regained consciousness shortly after. Sweaty, clammy, pale, did not remember what happened. Asked "what happened?". 911 was called, the paramedics came. Took vitals. They administered IV fluids and wheeled him out on a gurney in a neck brace.
23 2021-04-20 tingling WENT TO BED AFTER RECEIVING THE SHOT. WOKE UP WITH TINGLING/TICKLING SENSATION ALL THROUGHOUT BODY I... Read more
WENT TO BED AFTER RECEIVING THE SHOT. WOKE UP WITH TINGLING/TICKLING SENSATION ALL THROUGHOUT BODY INSIDE AND OUTSIDE. SPINE WOULD TINGLE WITH DEEP BREATH. BRAIN TINGLED/TICKLED WITH EACH STEP. SWALLOWING FOOD TICKLED THROAT. CLOTHES WOULD TICKLE SKIN. NOT SURE ABOUT DIFFERENCE BETWEEN TICKLING AND TINGLING AS I DO HAVE A HIGH PAIN TOLERANCE.
23 2021-04-20 seizure, grand mal seizure The patient developed fatigue, malaise, skin allodynia, fever (103.5F) and took acetaminophen and ib... Read more
The patient developed fatigue, malaise, skin allodynia, fever (103.5F) and took acetaminophen and ibuprofen. The fever resolved but he was diaphoretic. He also had a headache, vomiting, then lost consciousness overnight and had a tonic-clonic seizure lasting 10 minutes. He was brought to the emergency department and had 2 more seizures there which was controlled with lorazepam. He was admitted to the hospital and started on broad spectrum antibiotics (acyclovir, ceftriaxone, and vancomycin). On 4/11/21, the patient was extubated and improved symptomatically, and antibiotics were narrowed to doxycycline. He was then discharged on doxycycline and levetiracetam.
23 2021-04-20 tenderness Swollen eye lids (top and bottom), rash on face, hands, necks. Itchy all over. Throat tenderness a... Read more
Swollen eye lids (top and bottom), rash on face, hands, necks. Itchy all over. Throat tenderness and tight feeling
23 2021-04-20 tremor, seizure, unresponsive to stimuli While monitoring post-vaccination a woman yelled from her car window that ?he? fainted. Upon arrival... Read more
While monitoring post-vaccination a woman yelled from her car window that ?he? fainted. Upon arrival, it was noted that a young man in the passenger seat was slumped with his head on his chest and unresponsive. It was witnessed that the passenger stiffened and started shaking as if he was having a seizure. The nurse was called. It was noted that the shaking lasted just a few seconds and he then relaxed and opened his eyes. Once the RN, received call that there was a person having a seizure, 3 nurses went to the scene. Once RN arrived at the car the patient was awake and alert. The patient was assessed, and he was able to answer questions. History of the patient from the mother revealed that he has responded to other vaccines in the past by having a vagal response. RN noted that there were no signs of patient being postictal. Patient was alert, oriented and stated that he was feeling better. EMS arrived and assessed patient and noted that he was in no distress. Patient denied transport to ED. RN educated patient on importance of reporting this to nurse prior to next vaccination.
23 2021-04-22 flushing, unresponsive to stimuli Site: Pain at Injection Site-Mild, Systemic: Dizziness / Lightheadness-Medium, Systemic: Fainting / ... Read more
Site: Pain at Injection Site-Mild, Systemic: Dizziness / Lightheadness-Medium, Systemic: Fainting / Unresponsive-Medium, Systemic: Flushed / Sweating-Medium, Additional Details: Patient recieved the vaccine (sitting) and was instructed to sit for 15 minutes post vaccination.After about 5 minutes, patient stated that he was feeling light headed. Patient was seated when he fainted and was out for about 12-15 seconds. Patient came back and was able to speak with us.We provided him some water and called the EMT's. EMT's looked after patient/checked vitals and everything was okay. Patient states he has a fear of needles. Called patient a few hours after the incident to check
23 2021-04-22 muscle spasms Pt presented with sweating, nausea, muscle cramps and contractility after receiving 1st Moderna Vacc... Read more
Pt presented with sweating, nausea, muscle cramps and contractility after receiving 1st Moderna Vaccination
23 2021-04-22 seizure Patient had seizure event minutes after administration. Staff immediately called 911. Fire truck and... Read more
Patient had seizure event minutes after administration. Staff immediately called 911. Fire truck and ambulance arrived within minutes. Pharmacist attempted to administer epinephrine but failed. Seizure event lasted for approximately 30 seconds. Patient passed out but regained consciousness within a few seconds. Once patient regained consciousness, staff questioned patient about his whereabouts. Patient was able to answer questions about his name, date of birth and whereabouts.
23 2021-04-24 numbness Right leg feeling numb above knee, back side of leg. D/C'd home. Refused to be transported via ambu... Read more
Right leg feeling numb above knee, back side of leg. D/C'd home. Refused to be transported via ambulance to ER for evaluation and treatment as indicated. D/C'd at 12:55 p.m.
23 2021-04-25 cold sweat After sitting about 15 minutes, patient said he felt lightheaded. He was pale and a little clammy. ... Read more
After sitting about 15 minutes, patient said he felt lightheaded. He was pale and a little clammy. Gave patient water & stayed with him, because "he might faint". Blood pressure was taken. Initially was low, subsequent readings improved. No Epipen was given. He was talking & seemed to be improving. He was nervous, so 911 was called. He was much better by the time the EMTs arrived. The entire event including EMTs was @ 20 minutes. He felt well enough to shop in the store after.
23 2021-04-25 involuntary muscle movements Moderna COVID-19 Vaccine EUA: patient presents to emergency department with congitive decline and pe... Read more
Moderna COVID-19 Vaccine EUA: patient presents to emergency department with congitive decline and persistent abnormal movements for six months. Patient admitted, administered steroids for possible autoimmune etiology, initiated tetrabenazine for chorea, and discharged home in good condition with family and follow-up in place.
23 2021-04-26 feeling cold, seizure After providing the Moderna vaccine, patient passed out going forward in slow motion and head was re... Read more
After providing the Moderna vaccine, patient passed out going forward in slow motion and head was resting on table, then immediately started seizure-like action putting him in an upright position and I put my arms out to keep him from going forward and then he opened his eyes and came to. After talking to him while in observation, he mentioned that it felt like he was out for 5 minutes even though it only lasted for about 10-15 seconds. He mentioned that 12 years ago this happened (someone had thrown a rock and it hit his hand and when the nurse went to clean it, he went cold and when he came to it was exactly how it was after getting the vaccine). He only recalls feeling cold. When patient was about to leave, I suggested to him to reach out to his PCP to see if it's ok to give his 2nd dose with us or if he should be observed in a clinic setting. I did a follow up call a few hours later and he is doing fine.
23 2021-04-26 tenderness Soreness, chills
23 2021-04-27 cold sweat Pt reported feeling light headed, clammy and pale. Placed in semifowler's position, given a bottle o... Read more
Pt reported feeling light headed, clammy and pale. Placed in semifowler's position, given a bottle of water to drink and felt better. VSS and within acceptable parameters.
23 2021-04-27 feeling cold, tingling, cold sweat Within 5 minutes post-vaccination, the patient began to feel dizzy and requested some water. He look... Read more
Within 5 minutes post-vaccination, the patient began to feel dizzy and requested some water. He looked pallid, felt cold and clammy. I helped the patient out of his chair and onto the floor. I retrieved an instant cold pack and prepared it. When I returned to the patient 45 seconds later, he said the coolness of the ground helped. He did not feel dizzy anymore but his fingers were still tingling. I gave him the cold pack to place behind his neck and provided him a bottle of water. I had him lie prone for another 5 minutes. When I re-assessed, he was no longer feeling any negative symptoms and he no longer looked pale nor felt clammy.
23 2021-04-27 muscle spasms Pt alerted Oberving NP that he felt unwell. His BP was 88/68. He fainted-head slumped down and lost ... Read more
Pt alerted Oberving NP that he felt unwell. His BP was 88/68. He fainted-head slumped down and lost conciousness, his body spasmed one time and NP lowered him to the floor. He regained conciousness and we continued to monitor him and vital signs. BP returned to 133/84 and pt was transported to ER.
23 2021-04-28 cold sweat, tremor, feeling hot Patient received immunization and went to sit-down in post-immunization area. Their eyes rolled back... Read more
Patient received immunization and went to sit-down in post-immunization area. Their eyes rolled back and they started shaking. The episode lasted less than 1 minute. After this, patient was alert and oriented. Upon speaking with the patient they stated that they have this same reaction every time they give blood. They did not disclose this during the patient question or the pre-immunization interview with RPh. Patient felt hot and clammy, so we got patient an ice pack and advised they stay seated. We took patient's blood pressure and heart rate, both were normal. After monitoring patient a while longer patient stated they felt okay to leave.
23 2021-04-28 pain in extremity, weakness, grand mal seizure Extreme fatigue, pain in the arm, then swelling in the area around eyes, red-eye, and swollen red ey... Read more
Extreme fatigue, pain in the arm, then swelling in the area around eyes, red-eye, and swollen red eyelids, then the onset of rapid heart rate, difficulty breathing, extreme exhaustion, and low energy first onset of massive grand mal seizure occurred approximately 24 hours after injection.
23 2021-04-28 unresponsive to stimuli patient passed out 15 minutes after receiving shot. fell out of chair onto floor. helped up and sat... Read more
patient passed out 15 minutes after receiving shot. fell out of chair onto floor. helped up and sat in chair. pt was pale, tunnel vision and could not answer questions. gave some water and a granola bar because patient had not eaten since night before. called squad, pt refused treatment. stayed for another 30 minutes until determined ok to leave on his own volition.
23 2021-04-29 flushing, tingling, weakness Systemic: Dizziness / Lightheadness-Mild, Systemic: Flushed / Sweating-Mild, Systemic: Tingling (spe... Read more
Systemic: Dizziness / Lightheadness-Mild, Systemic: Flushed / Sweating-Mild, Systemic: Tingling (specify: facial area, extemities)-Mild, Systemic: Visual Changes/Disturbances-Mild, Systemic: Weakness-Mild, Additional Details: 5 minutes after vaccine was given, patient complained of blurry vision, lightheadedness, dizziness and L arm tingling and weakness extending to the digits. Resolved within 10 minutes after oral fluids and feet elevation. No lingering effects >2 hours after this event.
23 2021-04-29 pain in extremity Head ache, arm soreness, leg soreness, throwing up, unable to stay awake, diarrhea,fatigue
23 2021-04-30 flushing mainly noted flushing of skin mainly on both forearm- slightly itching/ sensitive sensation - no hi... Read more
mainly noted flushing of skin mainly on both forearm- slightly itching/ sensitive sensation - no hives , no edema noted - no other s/s of any breathing or swelling in oral mucosal area - remained alert no other stress -- recommended Benadryl OTC and pt was fine with recommendation and will contact to see pcp if any other worsening issues -- mainly want to know how to manage his second vaccination - what advise to give - recommend him to take Benadryl prior to next vaccine , or is he safe to get his second vaccination?
23 2021-04-30 unresponsive to stimuli Systemic: Fainting / Unresponsive-Medium, Systemic: Hypotension-Medium, Additional Details: Patient ... Read more
Systemic: Fainting / Unresponsive-Medium, Systemic: Hypotension-Medium, Additional Details: Patient received the vaccine and fainted 3-5 minutes later. Patient was standing when he fainted and upon fainting fell down backwards and hit his head on the floor. Paramedics/911 was called immediately. Patient was unresponsive for about 5-10 seconds. Upon waking up, patient seemed dazed at first, but quickly realized where he was and was responsive to questions. Paramedics took patient's blood pressure - it was low - and patient was taken to emergency room for further assessment/monitoring.
23 2021-05-01 tingling, sensory loss, numbness Initial numbness/tingling/loss of sensation on the left pinky. These symptoms then spread to the lef... Read more
Initial numbness/tingling/loss of sensation on the left pinky. These symptoms then spread to the left ring finger and have progressed until today. Monitoring daily as nothing has changed.
23 2021-05-02 feeling hot, cold sweat Client received first Moderna Covid 19 vaccine at 1615. Client tolerated vaccine well. Client was ... Read more
Client received first Moderna Covid 19 vaccine at 1615. Client tolerated vaccine well. Client was d/c'd from Covid clinic at 1630. No s/s of any distress noted at that time. Client was waiting in the waiting room for dental appointment in the same clinic. At 1700 dental staff came to get a medical staff due to client was not feeling well. Nurses walked in to dental office and found client laying down on the floor. Client was responding to the medical staff. Client was A+O x 4 . Client was clammy, diaphoretic, no SOB or wheezing noted, no swelling , no redness anywhere present, no n/v noted. Client stated that he laid him self down due to being very warm. Client took his Tshirt off prior laying him self down on the floor. Dental staff stated that client received Lidocaine and Epinephrine local anesthetic shortly prior. Dental staff claims that client did not lose his consciousness. Client confused about what happened moments before. Nursing assessment and VS taken. At 1703 VS BP 102/68, P 68, R 18, O2 sat 93% on RA. At 1705 O2 Sat at 100% on RA. Client was not sure why he felt like this per his statement. Client slowly set up and was talking to the nurse that is feeling better and less hot. Client A+O X 4 at all times. At 1705 VS BP 102/68, P 75, 18, O2 Sat 100% on RA. At 1710 Blood glucose level 126. Client received 8 oz. of OJ. Client stated that has not eaten anything in over 24 hours and not sleeping as well due to working night shift. Client sat him self up in the dental chair and stated that is feeling much better now. Client states all symptoms resolved. D/c'd home per dental staff. Dental appointment rescheduled.
23 2021-05-03 flushing Systemic: Dizziness / Lightheadness-Mild, Systemic: Flushed / Sweating-Mild, Systemic: Nausea-Mild, ... Read more
Systemic: Dizziness / Lightheadness-Mild, Systemic: Flushed / Sweating-Mild, Systemic: Nausea-Mild, Systemic: Vomiting-Mild
23 2021-05-05 unresponsive to stimuli, weakness Systemic: Confusion-Mild, Systemic: Dizziness / Lightheadness-Severe, Systemic: Fainting / Unrespons... Read more
Systemic: Confusion-Mild, Systemic: Dizziness / Lightheadness-Severe, Systemic: Fainting / Unresponsive-Severe, Systemic: Hypotension-Medium, Systemic: Weakness-Mild
23 2021-05-06 flushing Systemic: Dizziness / Lightheadness-Medium, Systemic: Flushed / Sweating-Medium, Additional Details:... Read more
Systemic: Dizziness / Lightheadness-Medium, Systemic: Flushed / Sweating-Medium, Additional Details: Patient reported feeling lightheaded and dizzy. patient sat in chair, removed mask to get air and drank some water. 911 was called as a precaution. a cool compress was placed on back of pt neck as directed by 911. vitals were within normal limits. pt reported feeling normal and walked to ambulance to sign paperwork as he reported not needing to go to the hospital.
23 2021-05-06 numbness, tingling Patient states that about one week after his COVID vaccine, he started randomly having numbness/ting... Read more
Patient states that about one week after his COVID vaccine, he started randomly having numbness/tingling in his left arm all the way to his hand. He did state that his shoulder was very sore for a few days following the vaccines, which is common. However, this feeling that his arm is "asleep" comes and goes randomly.
23 2021-05-06 seizure patient was seated in chair in waiting area about 2-3 minutes after vaccine. he started seizing and ... Read more
patient was seated in chair in waiting area about 2-3 minutes after vaccine. he started seizing and straightening up his body and began falling out of chair. i ran over and caught him before he fell all the way out. i supported him in the chair for about 10 seconds and he came to. the whole ordeal only lasted about 15 seconds. he said he felt weird and remembered dropping his phone. he stated he did not eat that morning. i gave him water and a snack and we watched him while EMS was called. they showed up in about 5 minutes. took vitals, everything came back normal. pt did not have hx of any disease states. parent picked him up from pharmacy.
23 2021-05-06 unresponsive to stimuli Systemic: Dizziness / Lightheadness-Mild, Systemic: Fainting / Unresponsive-Mild, Additional Details... Read more
Systemic: Dizziness / Lightheadness-Mild, Systemic: Fainting / Unresponsive-Mild, Additional Details: Patient slumped on chair at observation area within 5 minutes of vaccination but quickly regained consciousness when rph attempted to assist patient. Patient did not hit the ground and was unconscious for less than 30 seconds. patient urinated on self. blood pressure reading was 107/75mmhg and temperature was 97. Patient was monitored for more than 30 minutes afterward and left with a family member.
23 2021-05-07 migraine Chronic migraine headaches for at least 2-3 hours per day since 2 days after the second dose of the ... Read more
Chronic migraine headaches for at least 2-3 hours per day since 2 days after the second dose of the vaccine. I have never had a migraine in my life previously.
23 2021-05-09 pain in extremity Nausea, Fatigue, Arm pain
23 2021-05-11 tingling lightheadedness/ tingling sensation in head, fatigue, loose stools, sore throat, nasal congestion, d... Read more
lightheadedness/ tingling sensation in head, fatigue, loose stools, sore throat, nasal congestion, dry itchy skin. all started about a week after vaccination. patient evaluated one week after symptom onset. no concerning findings
23 2021-05-12 flushing Systemic: Dizziness / Lightheadness-Medium, Systemic: Fainting / Unresponsive-Severe, Systemic: Flus... Read more
Systemic: Dizziness / Lightheadness-Medium, Systemic: Fainting / Unresponsive-Severe, Systemic: Flushed / Sweating-Medium
23 2021-05-14 pain in extremity 05/13/2021: Very slight sore arm, time 15:30. Very sore arm and moderately high fatigue with some ... Read more
05/13/2021: Very slight sore arm, time 15:30. Very sore arm and moderately high fatigue with some faint body aches, time appx 20:00. 05/14/2021: Arm pain lessened but moderately high aches and muscle fatigue and slight nausea, appx 08:00. OTC cold and flu medicine alleviated symptoms. Light symptoms continued until appx 16:00
23 2021-05-14 seizure Systemic: Fainting / Unresponsive-Mild, Systemic: Patient fainted and exhibited seizure-like symptom... Read more
Systemic: Fainting / Unresponsive-Mild, Systemic: Patient fainted and exhibited seizure-like symptoms for a few seconds, then appeared to be okay-Mild, Systemic: Seizure-Mild, Additional Details: Patient fainted after administration of vaccine, and appeared to start seizing for a few seconds.
23 2021-05-16 feeling hot Patient claimed to not feel well (hot) shortly after receiving the vaccine. Pharmacist observed pati... Read more
Patient claimed to not feel well (hot) shortly after receiving the vaccine. Pharmacist observed patient to look slightly pale, and out of precaution called the EMS.
23 2021-05-17 feeling hot In a few minutes after vaccine administration , pt vomited a small amount and felt hot for few minut... Read more
In a few minutes after vaccine administration , pt vomited a small amount and felt hot for few minutes. pt started feeling better after few minutes and was monitored for at least for 15 minutes.
23 2021-05-17 numbness, tingling Bilateral hand and wrist numbness, weakness and tingling. First onset lasted about 2 hours, has been... Read more
Bilateral hand and wrist numbness, weakness and tingling. First onset lasted about 2 hours, has been returning intermittently for shorter episodes or longer but lessened symptoms
23 2021-05-17 migraine, pain in extremity Arm soreness/aches started about 6hrs in (though injection sight was tender/sensitive to the touch p... Read more
Arm soreness/aches started about 6hrs in (though injection sight was tender/sensitive to the touch pain became mostly localized around the armpit and shoulder area. Where the pectoral connects under the arm), then around 8hrs a headache and chills started. Chills and headache progressed and got significantly worse throughout the night. By around18hrs headache had progressed to a migraine and nausea started (likely due to the migraine). Simply sitting up in bed was enough to push nausea to vomiting at which the migraine subsided for about 30min-1hr. Chills and aching arm persisted. By 24hrs headache/migraine was nearly completely gone and chills had subsided. Arm pain persisted and got worse. Noticed around this time that there seemed to be mild swelling in the armpit. Around 48hrs in armpit area is still feels slightly swollen and causes a good bit a pain depending on how arm moves/rests. Injection sight still lightly tender. (currently the only symptom persisting)
23 2021-05-18 cold sweat After receiving Moderma vaccine, pt came to 15 minute wait area. once here, pt stated he started ge... Read more
After receiving Moderma vaccine, pt came to 15 minute wait area. once here, pt stated he started getting a headache. The headache stopped , then pt began feeling extremely tired and shaky. Broke out into cold sweat. Never passed out. Pt his arms felt lie they were "asleep" and fingers on his left hands felt like he could not move them, stiffened . No respiratory distress listed VS taken
23 2021-05-18 tingling, feeling cold Patient reports sensation change to right side of face, cold tingling sensation. Starting about 20-... Read more
Patient reports sensation change to right side of face, cold tingling sensation. Starting about 20-30 minutes after administration
23 2021-05-18 unresponsive to stimuli Systemic: Fainting / Unresponsive-Mild, Additional Details: Patient fell over after a few minutes af... Read more
Systemic: Fainting / Unresponsive-Mild, Additional Details: Patient fell over after a few minutes after vaccine. Pt was standing by pharmacy, declined sitting. Patient reports feeling a little dizzy, heard thud and fell over. Awake right after falling over, didn't black out. Pt hit back of head, reports no HA so far, hurts a little, but not dizzy. Pt called advice nurse, waiting to hear back. Pt reports don't need to go to urgent care or emergency. Will follow-up with primary provider. Spoke to pt about importance of seeing dr, make sure no bleeding/SE.
23 2021-05-19 flushing Systemic: Chills-Mild, Systemic: Dizziness / Lightheadness-Mild, Systemic: Flushed / Sweating-Mild, ... Read more
Systemic: Chills-Mild, Systemic: Dizziness / Lightheadness-Mild, Systemic: Flushed / Sweating-Mild, Additional Details: As per the patient: Passeed out before from different things (when he gets nervous).
23 2021-05-20 tingling Patient have 2nd Moderna vaccine administered at 2:02 pm . At 2:30 pm patient reported an itchy skin... Read more
Patient have 2nd Moderna vaccine administered at 2:02 pm . At 2:30 pm patient reported an itchy skin, vague tingling and mild throat closing. Patient was accessed by P.Bergen PA and Benadryl 25mg was administered per his order. Patient was sent to ED via ambulance.
23 2021-05-23 pain in extremity Within hours of vaccine, patient reports dizziness, fatigue, neck and shoulder pain radiating down a... Read more
Within hours of vaccine, patient reports dizziness, fatigue, neck and shoulder pain radiating down arm, headache. Symptoms have persisited since immunization 5/10/21.
23 2021-05-24 facial paralysis, mild one side paralysis Intraparenchymal Hemorrhage causing left sided weakness and left facial droop
23 2021-05-26 unresponsive to stimuli Systemic: Fainting / Unresponsive-Mild
23 2021-05-27 myelitis transverse Anti-MOG Transverse Myelitis
23 2021-05-27 tingling, burning sensation, pain in extremity, numbness, weakness Fever arm pain 24 hours after second shot 3 days after second shot: numbness, tingling in toes, some... Read more
Fever arm pain 24 hours after second shot 3 days after second shot: numbness, tingling in toes, some numbness, weak knees. Tight muscles These symptoms have continued now in 6th week. Now burning in toes at night waking him up.
23 2021-05-31 pain in extremity Fever, Chills, Headache, & Sore arm
23 2021-06-03 muscle spasms headache, muscle cramps, backache
23 2021-06-03 pain in extremity, feeling cold The vaccine is affecting young people; My son felt like he had an aneurysm in his neck/He had pain i... Read more
The vaccine is affecting young people; My son felt like he had an aneurysm in his neck/He had pain in the large artery on the right side of his neck like a myocardial inflammation or something; The right side of his neck, between the shoulder and neck, on the inside, he felt swelling, pressure pain, dull pain that comes and goes; On Tuesday, on the right side of his neck, between the shoulder and neck, on the inside, he felt swelling, pressure pain, dull pain that comes and goes; shoulder pain; On Saturday night he was feeling tired and cold; feeling cold; On Saturday his legs were very heavy and had pain, like he had blood clots or thrombosis in his veins; On Saturday his legs were very heavy and had pain; This spontaneous case was reported by a patient and describes the occurrence of THROMBOSIS (On Saturday his legs were very heavy and had pain, like he had blood clots or thrombosis in his veins) and ANEURYSM (My son felt like he had an aneurysm in his neck/He had pain in the large artery on the right side of his neck like a myocardial inflammation or something) in a 23-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 027L21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below. Concomitant products included BUPROPION HYDROCHLORIDE (ZYBAN) for an unknown indication. On 21-May-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 22-May-2021, the patient experienced THROMBOSIS (On Saturday his legs were very heavy and had pain, like he had blood clots or thrombosis in his veins) (seriousness criterion medically significant), PAIN IN EXTREMITY (On Saturday his legs were very heavy and had pain), FEELING COLD (feeling cold) and FATIGUE (On Saturday night he was feeling tired and cold). On 25-May-2021, the patient experienced ANEURYSM (My son felt like he had an aneurysm in his neck/He had pain in the large artery on the right side of his neck like a myocardial inflammation or something) (seriousness criterion medically significant), NECK PAIN (The right side of his neck, between the shoulder and neck, on the inside, he felt swelling, pressure pain, dull pain that comes and goes), SWELLING (On Tuesday, on the right side of his neck, between the shoulder and neck, on the inside, he felt swelling, pressure pain, dull pain that comes and goes) and ARTHRALGIA (shoulder pain). On an unknown date, the patient experienced VACCINATION COMPLICATION (The vaccine is affecting young people). At the time of the report, THROMBOSIS (On Saturday his legs were very heavy and had pain, like he had blood clots or thrombosis in his veins), ANEURYSM (My son felt like he had an aneurysm in his neck/He had pain in the large artery on the right side of his neck like a myocardial inflammation or something), VACCINATION COMPLICATION (The vaccine is affecting young people), PAIN IN EXTREMITY (On Saturday his legs were very heavy and had pain), NECK PAIN (The right side of his neck, between the shoulder and neck, on the inside, he felt swelling, pressure pain, dull pain that comes and goes), SWELLING (On Tuesday, on the right side of his neck, between the shoulder and neck, on the inside, he felt swelling, pressure pain, dull pain that comes and goes), FEELING COLD (feeling cold), ARTHRALGIA (shoulder pain) and FATIGUE (On Saturday night he was feeling tired and cold) outcome was unknown. No treatment information was provided. Company comment: Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded. This case was linked to MOD-2021-182543 (Patient Link).; Sender's Comments: Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded.
23 2021-06-06 weakness Patient started having generalized weakness, fatigue, fever and headache after the second dose of hi... Read more
Patient started having generalized weakness, fatigue, fever and headache after the second dose of his Moderna Covid-19 vaccine. These symptoms persisted throughout the next day. However, two days after the second Covid-19 shot patient developed severe chest pain that resulted in presentation in the ED. There was associated shortness of breath and diaphoresis. He was treated with Colchicine and Ibuprofen. He was also started on metoprolol because he had an 11-beat run of non-sustained ventricular tachycardia. He was discharged home on the fourth day to follow up with cardiology as outpatient.
23 2021-06-09 pain in extremity Myocarditis developed 2 days after second dose of Moderna Covid19 vaccination. Patient presented wi... Read more
Myocarditis developed 2 days after second dose of Moderna Covid19 vaccination. Patient presented with bilateral arm pain, left shoulder pain, and left chest pain that had started at 2300 the night before.
23 2021-06-13 numbness, tremor, tingling Tingling and numbness in left pinky and ring finger, feeling of discomfort in elbow, lower arm like ... Read more
Tingling and numbness in left pinky and ring finger, feeling of discomfort in elbow, lower arm like hit funny bone, left hand gets stiff and trembles when trying to extend. Mild symptoms first 2 days, but now significant and unable to type or use left arm without discomfort so have been resting it. Over 3 weeks with no improvement.
23 2021-06-13 tremor Patient was sitting in observation chairs and was observed leaning over the side of the chair. Phar... Read more
Patient was sitting in observation chairs and was observed leaning over the side of the chair. Pharmacist went to check on patient who regained consciousness and was able to talk. Patient requested emergency services when asked. He then proceeded to lose consciousness again for a few seconds and was held in his chair. He regained consciousness and was lowered to the ground. He continued to report dizziness, sweating, and shakiness. He remained conscious and talking until the paramedics arrived and assessed him. He was able to leave on his own and did not require any medical intervention.
23 2021-06-14 feeling hot Patient said he felt warm after the 1st dose for 30 minutes. He also said he had residual pain on... Read more
Patient said he felt warm after the 1st dose for 30 minutes. He also said he had residual pain on the left arm after the 1st dose. I offered to inject other arm, but he said he's right handed. After the 2nd dose (4/21/21), patient said he felt warm again, but not as warm as before. I offered him water, but he said no. I suggested he go straight home to get some rest. He had no visible sigh & symptoms of anaphylaxis.
23 2021-06-18 weakness Shortness of Breath, fever, chills, "blacking out," difficulty breathing, dizziness, nausea, vomiti... Read more
Shortness of Breath, fever, chills, "blacking out," difficulty breathing, dizziness, nausea, vomiting, weakness; starting after vaccination approximately 40 minutes. patient was at home at symptom onset
23 2021-06-19 weakness within 5 minutes, became light headed and very sweaty. blood pressure 78/50 taken twice on our autom... Read more
within 5 minutes, became light headed and very sweaty. blood pressure 78/50 taken twice on our automatic cuff. got pale, felt weak. got some color back by the time the medics arrived.
23 2021-06-21 numbness Numbness on toes and legs; Fever; The patient developed chronic inflammatory demilating polyneuropat... Read more
Numbness on toes and legs; Fever; The patient developed chronic inflammatory demilating polyneuropathy CIDP 3 days after receiving second dose of the vaccine on 16Apr2021; This spontaneous case was reported by a consumer and describes the occurrence of CHRONIC INFLAMMATORY DEMYELINATING POLYRADICULONEUROPATHY (The patient developed chronic inflammatory demilating polyneuropathy CIDP 3 days after receiving second dose of the vaccine on 16Apr2021) in a 23-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 007B21A and 043B21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below. No Medical History information was reported. On 19-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 16-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 19-Apr-2021, the patient experienced CHRONIC INFLAMMATORY DEMYELINATING POLYRADICULONEUROPATHY (The patient developed chronic inflammatory demilating polyneuropathy CIDP 3 days after receiving second dose of the vaccine on 16Apr2021) (seriousness criterion medically significant). On an unknown date, the patient experienced HYPOAESTHESIA (Numbness on toes and legs) and PYREXIA (Fever). At the time of the report, CHRONIC INFLAMMATORY DEMYELINATING POLYRADICULONEUROPATHY (The patient developed chronic inflammatory demilating polyneuropathy CIDP 3 days after receiving second dose of the vaccine on 16Apr2021) and PYREXIA (Fever) outcome was unknown and HYPOAESTHESIA (Numbness on toes and legs) had not resolved. Caller also mentioned that her son has numbness still after 8 weeks and also specified as numbness went away with steroid medication and reappeared after completing the dose. The patient received both scheduled doses of mRNA-1273 prior to the events, therefore action taken with the drug in response to the events was not applicable. Company comment: Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded. Further information has been requested.; Sender's Comments: Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded. Further information has been requested
23 2021-06-23 night sweats About 4 days post 2nd Moderna vaccine, patient started to develop shortness of breath, chest pain, a... Read more
About 4 days post 2nd Moderna vaccine, patient started to develop shortness of breath, chest pain, and night sweats.
23 2021-06-26 tingling Less than 24 hours after the second dose of the Moderna vaccine, I developed tingling and sensitivit... Read more
Less than 24 hours after the second dose of the Moderna vaccine, I developed tingling and sensitivity all over my body, fatigue, and tachycardia. I reported to the ED of UPMC Shadyside with a bmp of 130. My heart rate remained above 100 bmp throughout the course of the day. The ED team did not find signs of infection, blood clots, or heart inflammation after a multitude of lab tests. After a series of IV fluids and pain medications they were unable to lower my heart rate or find a cause and so I was discharged with instructions to hydrate and rest. The following day my heart rate remained elevated from my typical resting rate. It is not until today (6/27/2021), nearly 72 hours after the injection, that my heart rate has stabilized down to a more typical resting bpm for me.
23 2021-06-27 weakness PATIENT FAINTED AND FELL DOWN ON THE FLOOR INFRONT OF PHARMACY AT THE END OF HIS 15MINUTE WAITING P... Read more
PATIENT FAINTED AND FELL DOWN ON THE FLOOR INFRONT OF PHARMACY AT THE END OF HIS 15MINUTE WAITING PERIOD AFTER THE 1 DOSE OF MODERNA COVID-19 VACCINE. IMMEDIATELY ONE OF THE PHARMACY STAFF CALLED 911 AND THE PHARMACIST WENT OUT TO THE PATIENT TO GIVE MEDICAL HELP AND PATIENT REGAINED HIS CONSCIOUS IN A MINUTE AND SLOWLY HE STARTED TALKING. WHEN ASKED HOW HE IS FEELING,HE SAID THAT EVERYTHING BLACKED OUT AND HE IS FEELING LITTLE WEAK AND SWEATING. IN THE MEAN TIME EMS CAME AND TOOK HIS VITALS AND HE PASSED OUT AGAIN, EMS GAVE HIM MEDICAL ATTENTION AND THEY IMMEDIATELY TOOK HIM TO ORANGE PARK MEDICAL CENTER.
23 2021-06-30 flushing, unresponsive to stimuli Systemic: Dizziness / Lightheadness-Mild, Systemic: Fainting / Unresponsive-Mild, Systemic: Flushed ... Read more
Systemic: Dizziness / Lightheadness-Mild, Systemic: Fainting / Unresponsive-Mild, Systemic: Flushed / Sweating-Mild, Additional Details: Patient experienced syncopal episode within 5 minutes of administration of second dosage of Moderna Covid-19 vaccination, patient was unconscious less than 30 seconds, spontaneously awoken, and was fully recovered within 15 minutes.
23 2021-07-02 tingling, numbness, cold extremities Patient reported numbness/tingling in right hand and cold/numbness in left foot
23 2021-07-10 flushing Systemic: Dizziness / Lightheadness-Medium, Systemic: Flushed / Sweating-Medium, Systemic: Nausea-Me... Read more
Systemic: Dizziness / Lightheadness-Medium, Systemic: Flushed / Sweating-Medium, Systemic: Nausea-Medium, Additional Details: about 6 minutes after 1st dose was administered, pt complianed of lightheadedness, dizziness, nausea and sweating. His BP was 113/61, pulse was 46. he lay on the floor and elevated both feet onto a chair and immediately after doing so, the symptoms began to improve. his BP was re-checked at 11.32am 132/73 pulse 58. i reached out to the patient at 12.02pm and he noted that he was not experiencing any symptoms.
23 2021-07-16 flushing Flushing Feeling like I was going to pass out Joint pain
23 2021-07-21 seizure Approximately 12 hours after the shot, I began having seizures. I went to the emergency room twice f... Read more
Approximately 12 hours after the shot, I began having seizures. I went to the emergency room twice for seizure-related problems. I then saw a neurologist. The seizures are on-going.
23 2021-07-22 feeling hot, tingling Patient received vaccine in the left arm around 5:30 pm. About 2 minutes later, patient complained o... Read more
Patient received vaccine in the left arm around 5:30 pm. About 2 minutes later, patient complained of feeling hot and lightheaded and was sweating. We gave the patient some water to drink and continued to monitor his symptoms. After about 2-3 minutes, the patient said he was feeling much better, though he had a "tingling sensation" in his hands. We continued to monitor for another 15 minutes, after which the patient stated he was feeling much better.
23 2021-07-26 numbness Around 6 weeks after getting the shot I started getting weird sensations in my feet. At first I didn... Read more
Around 6 weeks after getting the shot I started getting weird sensations in my feet. At first I didn't give it too much importance. My feet where numb. The numbness started slowly going op my legs. To the point that I could not move them or feel anything. Took a plane to another city to get treated there. I wento to the ER on Tuesday the 22 nd of June, exactly two months after getting the shot. The sympthmos started about two weeks earlier. I spent a week at the hospital. I was diagnised with a an autonnmune desease triggered by the vaccine. An inflammatory polyneuropathy. Today (27th July 2021) I can walk and move, but still have strange feelings in my legs.
24 2021-01-03 feeling hot Fatigue at around 5pm. Chills at around 8 pm, with an underlying sense of head warmth. Fever at 9:45... Read more
Fatigue at around 5pm. Chills at around 8 pm, with an underlying sense of head warmth. Fever at 9:45 pm with a headache.
24 2021-01-03 tremor, migraine Extreme Tachycardia (HR 160-180s) for over 12 hours Uncontrolled cold shakes for over three hours Fe... Read more
Extreme Tachycardia (HR 160-180s) for over 12 hours Uncontrolled cold shakes for over three hours Fever for 24 hours Fatigue for 3+ days Tiredness 3+ days Body aches 3+ days Uncontrolled migraine over 48hrs
24 2021-01-05 weakness Patient received the vaccine around 2:50PM; checked in around 2:46PM. He was seated during his moni... Read more
Patient received the vaccine around 2:50PM; checked in around 2:46PM. He was seated during his monitoring phase when the nurse reported that the patient was complaining about: ? Dizziness ? Lightheadedness ? Weakness of extremities & general overall weakness ? Fast heartbeat ? These were noted to be part of the signs of severe allergic list for the vaccine. Upon assessment around 3PM, the nurse noted that the patient said he felt some of the symptoms were improving; no shortness of breath noted or facial swelling or rashes. Patient offered juice and crackers and advised to stay and continue monitoring. Patient compliant with plan. Around 305PM patient reassessed and patient started complaining of increasing weakness and dizziness and racing heartbeat. Patient also noted to have labored breathing, pale, clammy and tripoding. Vitals taken = 101/64; 100% in room air; HR = 80; RR = 32; lung sounds clear to auscultation. Patient kept on vital sign monitoring and noted that saturations started decreasing to 90%, then 80%, then down to 70% in a span of several minutes + HR = reduced to 55. Patient also stated he was feeling faint & started feeling very weak & stopped talking & having difficulty breathing. MERT called and patient placed in a wheelchair & oxygen administered. Patient continued to look worse and not as responsive. MERT arrived around 317PM and took another set of vitals and brought patient to ED.
24 2021-01-08 cold sweat, weakness Fever, chills, cold sweats, fatigue, dry cough, headache, muscle pain, and weakness lasting 12 hours... Read more
Fever, chills, cold sweats, fatigue, dry cough, headache, muscle pain, and weakness lasting 12 hours starting at around 24 hours after vaccine administration. Patient took two Tylenol 500mg to some relief at 2pm and again at 7pm.
24 2021-01-16 tingling Left Axillary pain and mild swelling starting approximately 4 days after vaccination. The pain proce... Read more
Left Axillary pain and mild swelling starting approximately 4 days after vaccination. The pain proceeded to worsen over the next week and moderate lymphadenopathy was also been noted. These lymph nodes are tender to palpation. Additionally some Parasthesias were felt down the left forearm into the hand possibly due to brachial neuritis or nerve pressure due to lymphadenopathy. The parasthesias lasted approximately 2 days. Lymphadenopathy is now present in the right axilla along with more severe adenopathy in the left axilla. - PA-S2
24 2021-01-16 tremor, hypersensitivity of all senses One hour after injection, at 1500, i experienced high sensitivity to pain. Every inch of my limbs ac... Read more
One hour after injection, at 1500, i experienced high sensitivity to pain. Every inch of my limbs ached, including headaches. I took ibuprofen, but was later advised against it. The next day around 1300 i experienced chills and began shaking uncontrollably. It didn't stop for an hour, where i got incredibly nauseous and tired and slept the rest of the day. The next day, starting at 0700, i felt the need to vomit and had diarrhea. This continued until i fell asleep at 1030. Afterwards the majority of my problems passed.
24 2021-01-17 tremor Had fever of 102 which slowly lowered throughout the next 24 hours until gone. Had severe shaking (... Read more
Had fever of 102 which slowly lowered throughout the next 24 hours until gone. Had severe shaking (trembling) for about an hour. All this started about 12 hours after getting the vaccine.
24 2021-01-18 pain in extremity Moderna COVID-19 Vaccine EUA. Fever of 100 degrees, really sore arm, fatigue, more intense hunger th... Read more
Moderna COVID-19 Vaccine EUA. Fever of 100 degrees, really sore arm, fatigue, more intense hunger than usual. Fever started about 24 hours after vaccination. Sore arm about 4 hours after. Hunger and fatigue within two hours. Taking occasional Tylenol for sore arm, not sure how effective it is.
24 2021-01-19 pain in extremity 24 year old male who had his COVID vaccination 08:00 yesterday. By last night about 22:00, he start ... Read more
24 year old male who had his COVID vaccination 08:00 yesterday. By last night about 22:00, he start an upset stomach. He has thrown up twice. 4-5 episodes diarrhea. Body aches. No fever. Little bit of scratchy throat but no itching or difficulty swallowing. No skin rash. Left arm where he got shot is sore but is not red or swollen. He has not taken anything for this. He is concerned he is reacting to the COVID vaccination. Patient describes symptom is mild-to-moderate. But just concerned so he came in. No known infectious exposure. He is active duty and works as security at the front gate. Air Force is vaccinating all their essential personnel. Allergies/ Adverse Reactions: No Known Drug Allergies Allergy (Verified 01/15/21 03:38)
24 2021-01-20 tremor, slurring Pt became lethargic, slow to respond, speech muttered, shaking, drooping right eye, nauseous. BP 169... Read more
Pt became lethargic, slow to respond, speech muttered, shaking, drooping right eye, nauseous. BP 169/108, O2 sat=98%, pulse 100. Paramedics called and patient transferred to hospital.
24 2021-01-24 weakness, pain in extremity I had the normal sore arm. I ended up the next day with stuffy nose, sore throat, tired, weak. The n... Read more
I had the normal sore arm. I ended up the next day with stuffy nose, sore throat, tired, weak. The next day I had the post nasal drip and really fatigue and my sugars were running high, cough and swollen glands. The third day I went to the Doctor to get Covid test, it was negative. The Dr. said I had a chest infections, post nasal drip. It took about two weeks to go away, they didn't want to give me any medication because they didn't know about the shot. I had two Covid test and they were negative.
24 2021-01-24 numbness, tingling A few hours after the injection, I started feeling severe joint and back pain. Around 5 PM is when I... Read more
A few hours after the injection, I started feeling severe joint and back pain. Around 5 PM is when I started feeling a tingling feeling in my hands, feet, and around the outside of my mouth. I still have a loss of feeling in my feet after returning to work today, 1/25/2021, and I was promptly sent home after informing my management. I still have some loss of feeling around the corners of my mouth, and most of the feeling has recovered in my hands.
24 2021-01-24 pain in extremity Intermittent fever 101.9 1/23 @0717PM -- Tachycardia 130hr 1/23 @0717PM -- 138hr 1/23 @0921PM --- 1... Read more
Intermittent fever 101.9 1/23 @0717PM -- Tachycardia 130hr 1/23 @0717PM -- 138hr 1/23 @0921PM --- 113hr 1/24 @0422AM -- 117hr 1/24 @0704PM Body aches/Chills -- 1/23 @0722PM Right arm pain, hard nodule palpated, and warmth to touch at injection site -- reported 1/24 @0149PM Reported bloody nares. (dried blood witnessed on wash cloth) -- reported 1/24 @0149PM Mild Headache 1/23 @0722PM Painful lump at right axillary that was not near prior to injection -- reported 1/24 @0149PM
24 2021-01-25 weakness 01/21/2021 11:22am HCP #2 Triage for COVID 19 SEVERE post Vaccine Reaction VAERS reportable Contact ... Read more
01/21/2021 11:22am HCP #2 Triage for COVID 19 SEVERE post Vaccine Reaction VAERS reportable Contact #: Your concerns: Dept: Have you missed work? #shifts: today Did you seek emergency care? yes Date and Time of Vaccine: 1/20/2021 @ Age at time of vaccination, ____24____ years Sex: m Was the vaccine received at facility? yes Site of vaccine (LD or RD): LD Type of Vaccine Pfizer ( X) Moderna ( ) Other _______________ 1st or 2nd dose: 2nd When did your symptoms start? 1/20/2021 Please note reported symptoms yes or no, these symptoms are considered mild to moderate and are NOT VAERS reportable Injection site pain yes Tiredness yes Headache yes Muscle Pain yes Chills yes Joint Pain yes Fever (note temp if known) no Injection Site Swelling no Injection Site Redness no Nausea no Feeling Unwell yes Swollen Lymph Nodes (lymphadenopathy) no Other: Patient reports THE FOLLOWING SEVERE post vaccine ADVERSE reactions (reportable): Difficulty breathing no Swelling of your face and throat swelling of the lower lip A fast heartbeat relates heart rate greater than 110 A bad rash all over your body no Dizziness and weakness If COVID-19 symptoms persist and/or worsen beyond 48 hours consider COVID-19 testing Treatment/Advise: Plan: Consulted with HCP, patient sent to urgent care clinic for further evaluation. If patient was vaccinated at another facility, they need to contact that facility , it is an expectation that the facility that gave the vaccine complete the VAERS report. Patient verbalizes understanding and agreement with plan. VAERS report is completed electronically if vaccine given at facility. Signed by HCP on 1/21/2021 at 11:22am
24 2021-01-26 tingling Tingling in chest and