chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Sex: M
Vaccine: COVID19
Symptoms: Atrial fibrillation, Atrial flutter, Blood glucose, Blood glucose abnormal, Insomnia
Clinical narrative: ATRIAL FIBRILLATION IN LEFT ATRIUM; ATRIAL FIBRILLATION FLUTTER IN RIGHT ATRIUM; BLOOD GLUCOSE LEVEL WERE HIGH; INSOMNIA; DIGESTIVE PROBLEMS WITH  SYMPTOMS LIKE IRRITABLE BOWEL; This spontaneous report received from a patient via a company representative concerned a 6 decade old male of Asian race and unknown ethnicity. The patient's height, and weight were not reported. Patient's checkup in fall was normal prior to vaccination. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: Unknown expiry: unknown) dose was not reported, 1 total administered on 17-MAR-2021 for prophylactic vaccination. The batch number was not reported and has been requested. No concomitant medications were reported. On 31-MAR-2021, after two weeks the patient developed digestive problems, insomnia and symptoms like irritable bowel. Symptoms persisted for 6 weeks. The patient went to the doctor and was diagnosed with atrial fibrillation in left atrium and was hospitalized at the end of MAY-2021. The patient received Amiodarone for atrial fibrillation. The patient didn't tolerate medication and they tried cardioversion which worked and he was discharged. One week after the patient was diagnosed with atrial fibrillation and re-hospitalized where cardio ablation was performed. It worked and patient was discharged. One week later the patient was diagnosed with an atrial fibrillation flutter in right atrium and cardio ablation was performed that worked on patient. The patient was discharged and placed on Eliquis. The patient will be followed up with every 3 months. Blood glucose (BG) levels were high at the time of reporting and which was new for the patient. The levels were improved over the last month with exercise and diet. The patient had a well visit last fall and was completely health prior. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from insomnia, and digestive problems with symptoms like irritable bowel on 12-MAY-2021, was recovering from blood glucose level were high, and the outcome of atrial fibrillation in left atrium and atrial fibrillation flutter in right atrium was not reported. This report was serious (Hospitalization Caused / Prolonged).; Sender's Comments: V0: 20210800922- Covid-19 vaccine ad26.cov2.s- Atrial fibrillation in left atrium, Atrial fibrillation flutter in right atrium . This event(s) is considered unassessable. The event(s) has a compatible/suggestive temporal relationship, is unlabeled, and has unknown scientific plausibility. There is no information on any other factors potentially associated with the event(s).
Sex: M
Vaccine: COVID19
Symptoms: Irritable bowel syndrome
Clinical narrative: ATRIAL FIBRILLATION IN LEFT ATRIUM; ATRIAL FIBRILLATION FLUTTER IN RIGHT ATRIUM; BLOOD GLUCOSE LEVEL WERE HIGH; INSOMNIA; DIGESTIVE PROBLEMS WITH  SYMPTOMS LIKE IRRITABLE BOWEL; This spontaneous report received from a patient via a company representative concerned a 6 decade old male of Asian race and unknown ethnicity. The patient's height, and weight were not reported. Patient's checkup in fall was normal prior to vaccination. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: Unknown expiry: unknown) dose was not reported, 1 total administered on 17-MAR-2021 for prophylactic vaccination. The batch number was not reported and has been requested. No concomitant medications were reported. On 31-MAR-2021, after two weeks the patient developed digestive problems, insomnia and symptoms like irritable bowel. Symptoms persisted for 6 weeks. The patient went to the doctor and was diagnosed with atrial fibrillation in left atrium and was hospitalized at the end of MAY-2021. The patient received Amiodarone for atrial fibrillation. The patient didn't tolerate medication and they tried cardioversion which worked and he was discharged. One week after the patient was diagnosed with atrial fibrillation and re-hospitalized where cardio ablation was performed. It worked and patient was discharged. One week later the patient was diagnosed with an atrial fibrillation flutter in right atrium and cardio ablation was performed that worked on patient. The patient was discharged and placed on Eliquis. The patient will be followed up with every 3 months. Blood glucose (BG) levels were high at the time of reporting and which was new for the patient. The levels were improved over the last month with exercise and diet. The patient had a well visit last fall and was completely health prior. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from insomnia, and digestive problems with symptoms like irritable bowel on 12-MAY-2021, was recovering from blood glucose level were high, and the outcome of atrial fibrillation in left atrium and atrial fibrillation flutter in right atrium was not reported. This report was serious (Hospitalization Caused / Prolonged).; Sender's Comments: V0: 20210800922- Covid-19 vaccine ad26.cov2.s- Atrial fibrillation in left atrium, Atrial fibrillation flutter in right atrium . This event(s) is considered unassessable. The event(s) has a compatible/suggestive temporal relationship, is unlabeled, and has unknown scientific plausibility. There is no information on any other factors potentially associated with the event(s).
Age: 77.0
Sex: M
Vaccine: COVID19
Symptoms: Herpes zoster, Neuropathy peripheral
Clinical narrative: NEUROPATHY; SHINGLES OUTBREAK/SHINGLES RASH; This spontaneous report received from a patient concerned a 77 year old Male. The patient's height, and weight were not reported. The patient's past medical history included shingles outbreak- last time was 12 years ago and concurrent conditions included non alcohol user, and non smoker and other pre-existing medical conditions included the patient was allergic to unspecified antibiotic. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported and batch number: A240421 expiry: UNKNOWN) dose was not reported,1 total, administered on left arm on 03-MAY-2021 for prophylactic vaccination. No concomitant medications were reported.  On an unspecified date in MAY-2021, the patient experienced shingles outbreak/shingles rash and he began to experience severe pain around mid stomach on left side under breast area 3-4 inches long and 1 inch wide around the middle side and back. The patient reported he put off seeing his doctor for about a week after pain symptoms began. The patient reported going to the doctor one week after symptoms began for the pain he was experienced  and doctor discovered the shingles rash. On an unspecified date in JUN-2021, treatment medications included: gabapentin, and tramadol. On 03-JUN-2021, treatment medications included: valaciclovir. The patient said the pain began at least a week and a half before he began the valacyclovir. On an unspecified date, he still has lingering pain (neuropathy) since he waited to see the doctor for assessment after symptoms began. Additional treatment medications (dates unspecified) included: acetylsalicylic acid, aspirin and oxycodone hydrochloride/paracetamol. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered with sequelae from shingles outbreak/shingles rash, and had not recovered from neuropathy. This report was serious (Other Medically Important Condition).; Sender's Comments: V0: 20210801276-Covid-19 vaccine ad26.cov2.s -Neuropathy. This event(s) is considered not related. The event(s) has a compatible/suggestive temporal relationship, is unlabeled, and has unknown scientific plausibility. There are other factors more likely to be associated with the event(s) than the drug. Specifically: MEDICAL HISTORY
Sex: U
Vaccine: COVID19
Symptoms: Injection site pain, Pyrexia
Clinical narrative: PAIN ON INJECTION SITE; FEVER; This spontaneous report received from a patient via a company representative concerned a patient of unspecified age and sex. The patient's height, and weight were not reported. No past medical history or concurrent conditions were reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: Unknown) dose was not reported, administered on JUL-2021 for prophylactic vaccination. The batch number was not reported. Per procedure, no follow-up will be requested for this case. No concomitant medications were reported. On JUL-2021, the subject experienced pain on injection site. On JUL-2021, the subject experienced fever. The action taken with Covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from pain on injection site, and fever. This report was non-serious.
Sex: M
Vaccine: COVID19
Symptoms: Chills
Clinical narrative: CHILLS; This spontaneous report received from a patient via a company representative concerned a male of unspecified age. The patient's height, and weight were not reported. No past medical history or concurrent conditions were reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: Unknown) dose, start therapy date were not reported for prophylactic vaccination. The batch number was not reported. Per procedure, no follow-up will be requested for this case. No concomitant medications were reported. On an unspecified date, the subject experienced chills. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of chills was not reported. This report was non-serious.
Age: 73.0
Sex: F
Vaccine: COVID19
Symptoms: Blood pressure increased, Heart rate increased
Clinical narrative: Blood pressure spike; Heart rate spike; This spontaneous case was reported by a consumer and describes the occurrence of BLOOD PRESSURE INCREASED (Blood pressure spike) and HEART RATE INCREASED (Heart rate spike) in a 73-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 024M20A) for COVID-19 vaccination.     Concurrent medical conditions included Hypertension.    On 11-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 18-Feb-2021, the patient experienced BLOOD PRESSURE INCREASED (Blood pressure spike) (seriousness criterion medically significant) and HEART RATE INCREASED (Heart rate spike) (seriousness criterion medically significant). The patient was treated with CLONIDINE for Adverse event, at an unspecified dose and frequency. On 18-Feb-2021, BLOOD PRESSURE INCREASED (Blood pressure spike) and HEART RATE INCREASED (Heart rate spike) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       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.   Most recent FOLLOW-UP information incorporated above includes: On 31-Jul-2021: Follow-up received contains no new information.; 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.
Age: 64.0
Sex: M
Vaccine: COVID19
Symptoms: Dyspnoea
Clinical narrative: Difficult breathing; This spontaneous case was reported by a consumer and describes the occurrence of DYSPNOEA (Difficult breathing) in a 64-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 045A21A) for COVID-19 vaccination.     No Medical History information was reported.    On 23-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 24-Mar-2021, the patient experienced DYSPNOEA (Difficult breathing) (seriousness criterion medically significant). At the time of the report, DYSPNOEA (Difficult breathing) had not resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Concomitant drug was not reported.  Treatment for the event was not reported.  The patient visited Emergency room on 24 Mar 2021.  Based on the current available information and temporal association between the use of the product and the start date of event, a causal relationship cannot be excluded.   Most recent FOLLOW-UP information incorporated above includes: On 02-Aug-2021: TCR document attached Containing Non significant information. event upgraded to serious as per MR; Sender's Comments: Based on the current available information and temporal association between the use of the product and the start date of event, a causal relationship cannot be excluded.
Age: 59.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Chest X-ray, Dysphagia, Dyspnoea, Speech disorder, Throat tightness
Clinical narrative: Experienced shortness of breath, throat tightness, difficulty swallowing and talking.
Age: 59.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Dyspnoea, Throat tightness
Clinical narrative: Experienced shortness of breath, throat tightness, difficulty swallowing and talking.
Age: 53.0
Sex: F
Vaccine: COVID19
Symptoms: Eyelid sensory disorder, Facial paralysis, Hypoaesthesia, Immediate post-injection reaction, Muscular weakness
Clinical narrative: Immediately after the shot vision became blurred/distorted. I would not say "double vision" per se, but distorted, blurry, difficult to see.  This cleared within about 2-3 minutes of the shot. After the wait time of 15 min, maybe 20-30 min. later, started having numbness on left side of face and across forehead. Then felt pressure/swelling around both eyes and numbness/tingling in them. Checked in mirror-droopy left eye and less wrinkling in left forehead.  After 4 hours symptoms were not getting better but stronger, so called doctor. Doctor recommended benadryl. Took benadryl and it helped with the eye issue and numbness.  The next day symptoms were back but a bit less severe.  Eyes were swollen and crusted over, numbness and feeling like had eye drops from eye doctor to check for glaucoma.  Eyes were sensitive to light as well. Friday most symptoms seemed much less. Sunday swelling of hands and eyes/face again, right leg weakness.  Drank extra water, symptoms less the following days.  The eye issue is persisting at a low level-light sensitivity after day 6 still, some numbness and swelling that comes and goes.  Right leg weak day 6. Day 7 woke up symptoms appearing less so far today.  Will check with doctor again about the eye issue to see if need to do anything else but it seems to be getting better slowly over time.
Age: 53.0
Sex: F
Vaccine: COVID19
Symptoms: Ocular discomfort, Peripheral swelling, Photophobia, Vision blurred
Clinical narrative: Immediately after the shot vision became blurred/distorted. I would not say "double vision" per se, but distorted, blurry, difficult to see.  This cleared within about 2-3 minutes of the shot. After the wait time of 15 min, maybe 20-30 min. later, started having numbness on left side of face and across forehead. Then felt pressure/swelling around both eyes and numbness/tingling in them. Checked in mirror-droopy left eye and less wrinkling in left forehead.  After 4 hours symptoms were not getting better but stronger, so called doctor. Doctor recommended benadryl. Took benadryl and it helped with the eye issue and numbness.  The next day symptoms were back but a bit less severe.  Eyes were swollen and crusted over, numbness and feeling like had eye drops from eye doctor to check for glaucoma.  Eyes were sensitive to light as well. Friday most symptoms seemed much less. Sunday swelling of hands and eyes/face again, right leg weakness.  Drank extra water, symptoms less the following days.  The eye issue is persisting at a low level-light sensitivity after day 6 still, some numbness and swelling that comes and goes.  Right leg weak day 6. Day 7 woke up symptoms appearing less so far today.  Will check with doctor again about the eye issue to see if need to do anything else but it seems to be getting better slowly over time.
Age: 38.0
Sex: F
Vaccine: COVID19
Symptoms: Blepharospasm, Fatigue, Headache, Myalgia
Clinical narrative: Chronic Fatigue  Headaches  Eye twitching Muscle soreness
Age: 56.0
Sex: F
Vaccine: COVID19
Symptoms: Chest pain, Electrocardiogram normal, Heart rate increased, Painful respiration
Clinical narrative: Pt. started to have to exhibit chest pain and breathing, rapid pulse was 110.  911 was called for further evaluation.  EMT took EKG.  Normal sinus rhythm. Pt. stated the chest pain has subsided.  Pt. refused to go to emergency for further evaluation
Age: 34.0
Sex: F
Vaccine: COVID19
Symptoms: Herpes zoster, Rash
Clinical narrative: Shingles R Pelvis lower back, no antiviral treatment. 5 week course
Age: 32.0
Sex: F
Vaccine: COVID19
Symptoms: Dizziness
Clinical narrative: Dizzy
Age: 61.0
Sex: M
Vaccine: COVID19
Symptoms: Vaccination site rash
Clinical narrative: Large rash at vaccination site on right arm (5 inches in diameter) lasting for about two weeks
Age: 20.0
Sex: M
Vaccine: COVID19
Symptoms: Confusional state, Dizziness, Syncope, Unresponsive to stimuli
Clinical narrative: Systemic: Confusion-Medium, Systemic: Dizziness / Lightheadness-Severe, Systemic: Fainting / Unresponsive-Severe
Age: 50.0
Sex: F
Vaccine: COVID19
Symptoms: Iritis
Clinical narrative: Iritis
Age: 18.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Eye swelling, Mouth swelling, Swelling face, Swollen tongue
Clinical narrative: Systemic: Allergic: Swelling of Face/Eyes/Mouth/Tongue-Mild. Additional Details: Patient reported she swelling of the tongue the night after getting the COVID shot. She said she noticed it around 4 am and took some Benadryl. She felt better. She said it was noticeable but not a severe swelling/reaction. Possibly related to the COVID shot she got earlier, which was in the afternoon at around 2 pm. Patient has not come in for second shot and unsure if it is safe for her to get the second shot.
Age: 18.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Swollen tongue
Clinical narrative: Systemic: Allergic: Swelling of Face/Eyes/Mouth/Tongue-Mild. Additional Details: Patient reported she swelling of the tongue the night after getting the COVID shot. She said she noticed it around 4 am and took some Benadryl. She felt better. She said it was noticeable but not a severe swelling/reaction. Possibly related to the COVID shot she got earlier, which was in the afternoon at around 2 pm. Patient has not come in for second shot and unsure if it is safe for her to get the second shot.
Age: 70.0
Sex: M
Vaccine: COVID19
Symptoms: Haemorrhagic stroke
Clinical narrative: had a stroke, haemorrhagic stroke/ bleeding at the brain, bleeding at the brain, had to learn to talk again, couldn't eat or swallow food and still has trouble with his right hand; This spontaneous case was reported by a consumer and describes the occurrence of HAEMORRHAGIC STROKE (had a stroke, haemorrhagic stroke/ bleeding at the brain, bleeding at the brain, had to learn to talk again, couldn't eat or swallow food and still has trouble with his right hand) in a 70-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     Concomitant products included TAMSULOSIN, SPIRONOLACTONE, ACETYLSALICYLIC ACID (ASPIRIN ACTIV), CARVEDILOL, LISINOPRIL, MIRTAZAPINE, ATORVASTATIN and OMEPRAZOLE for an unknown indication.   On 25-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 22-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 05-Mar-2021, the patient experienced HAEMORRHAGIC STROKE (had a stroke, haemorrhagic stroke/ bleeding at the brain, bleeding at the brain, had to learn to talk again, couldn't eat or swallow food and still has trouble with his right hand) (seriousness criteria hospitalization and medically significant). The patient was hospitalized from 05-Mar-2021 to 05-Apr-2021 due to HAEMORRHAGIC STROKE. The patient was treated with Rehabilitation therapy (had to learn to talk and work with his hands again, He couldn't eat or swallow food and had to re-le) for Haemorrhagic stroke. At the time of the report, HAEMORRHAGIC STROKE (had a stroke, haemorrhagic stroke/ bleeding at the brain, bleeding at the brain, had to learn to talk again, couldn't eat or swallow food and still has trouble with his right hand) had resolved with sequelae.            patient experienced hemorrhagic stroke, with bleeding in the brain. Patient was hospitalized and  put on a ventilator for 2-3 days to make blood pressure down to stop the bleeding. Patient was in rehab at the hospital for 20 days and was discharged around 5APR2021.  Patient has doing better now but still had trouble talking and right hand still has some trouble doing things.   The treatment history was not reported. Action taken with mRNA-1273 in response to the event was not applicable.  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.  More 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.  More information has been requested.
Age: 54.0
Sex: M
Vaccine: COVID19
Symptoms: Pulmonary embolism
Clinical narrative: pulmonary embolism; This spontaneous case was reported by a consumer and describes the occurrence of PULMONARY EMBOLISM (pulmonary embolism) in a 54-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.   On 15-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 13-May-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 27-Jul-2021, the patient experienced PULMONARY EMBOLISM (pulmonary embolism) (seriousness criteria medically significant and life threatening). The patient was treated with HEPARIN for Pulmonary embolism, at an unspecified dose and frequency. At the time of the report, PULMONARY EMBOLISM (pulmonary embolism) outcome was unknown.            No treatment information provided.  Comment company: 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.; 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.
Age: 84.0
Sex: M
Vaccine: COVID19
Symptoms: Cerebrovascular accident, Dementia, Limb discomfort, Mood swings, Product dose omission issue
Clinical narrative: stroke; dementia has advanced more; more than 42 days for second dose; mood swings; yell and Screaming; stroke affected husband's right arm; This spontaneous case was reported by a consumer and describes the occurrence of CEREBROVASCULAR ACCIDENT (stroke) and DEMENTIA (dementia has advanced more) in an 84-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 002A21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     Concurrent medical conditions included Rheumatoid arthritis, Cancer and Dementia.    On 02-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced CEREBROVASCULAR ACCIDENT (stroke) (seriousness criteria hospitalization and medically significant), DEMENTIA (dementia has advanced more) (seriousness criterion medically significant), PRODUCT DOSE OMISSION ISSUE (more than 42 days for second dose), MOOD SWINGS (mood swings), SCREAMING (yell and Screaming) and LIMB DISCOMFORT (stroke affected husband's right arm). The patient was hospitalized on 27-Mar-2021 due to CEREBROVASCULAR ACCIDENT. At the time of the report, CEREBROVASCULAR ACCIDENT (stroke), DEMENTIA (dementia has advanced more), PRODUCT DOSE OMISSION ISSUE (more than 42 days for second dose), MOOD SWINGS (mood swings), SCREAMING (yell and Screaming) and LIMB DISCOMFORT (stroke affected husband's right arm) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Patient right arm affected due to stroke. He took a lot of medication. He also took a treatment for cancer.  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.  Very limited information has been provided at this time. Further information is expected.; 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.  Very limited information has been provided at this time. Further information is expected
Age: 84.0
Sex: M
Vaccine: COVID19
Symptoms: Screaming
Clinical narrative: stroke; dementia has advanced more; more than 42 days for second dose; mood swings; yell and Screaming; stroke affected husband's right arm; This spontaneous case was reported by a consumer and describes the occurrence of CEREBROVASCULAR ACCIDENT (stroke) and DEMENTIA (dementia has advanced more) in an 84-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 002A21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     Concurrent medical conditions included Rheumatoid arthritis, Cancer and Dementia.    On 02-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced CEREBROVASCULAR ACCIDENT (stroke) (seriousness criteria hospitalization and medically significant), DEMENTIA (dementia has advanced more) (seriousness criterion medically significant), PRODUCT DOSE OMISSION ISSUE (more than 42 days for second dose), MOOD SWINGS (mood swings), SCREAMING (yell and Screaming) and LIMB DISCOMFORT (stroke affected husband's right arm). The patient was hospitalized on 27-Mar-2021 due to CEREBROVASCULAR ACCIDENT. At the time of the report, CEREBROVASCULAR ACCIDENT (stroke), DEMENTIA (dementia has advanced more), PRODUCT DOSE OMISSION ISSUE (more than 42 days for second dose), MOOD SWINGS (mood swings), SCREAMING (yell and Screaming) and LIMB DISCOMFORT (stroke affected husband's right arm) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Patient right arm affected due to stroke. He took a lot of medication. He also took a treatment for cancer.  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.  Very limited information has been provided at this time. Further information is expected.; 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.  Very limited information has been provided at this time. Further information is expected
Age: 14.0
Sex: F
Vaccine: COVID19
Symptoms: Abdominal pain, Fatigue, Lethargy
Clinical narrative: Systemic: Abdominal Pain-Mild, Systemic: Exhaustion/Lethargy-Severe.
Age: 39.0
Sex: M
Vaccine: COVID19
Symptoms: Dizziness, Fall, Flushing, Head injury, Hyperhidrosis
Clinical narrative: Systemic: Dizziness / Lightheadness-Medium, Systemic: Fainting / Unresponsive-Severe, Systemic: Flushed / Sweating-Severe, Additional Details: patient passed out and fell to floor and hit head on chair. was out for 30 seconds to a minute
Age: 39.0
Sex: M
Vaccine: COVID19
Symptoms: Loss of consciousness, Syncope, Unresponsive to stimuli
Clinical narrative: Systemic: Dizziness / Lightheadness-Medium, Systemic: Fainting / Unresponsive-Severe, Systemic: Flushed / Sweating-Severe, Additional Details: patient passed out and fell to floor and hit head on chair. was out for 30 seconds to a minute
Age: 48.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Burning sensation, Muscle spasms, Muscle twitching
Clinical narrative: The evening of March 15th started experiencing twitches/spasms in my legs and arms then over my body. Symptoms started getting better in June. Took 2nd dose on July 25th and started getting twitches/spasms again also experiencing burning sensation in my right heel.  Started taking Magnesium and B12 on Aug 1st for the twitches that is still occurring.
Sex: U
Vaccine: COVID19
Symptoms: Electrocardiogram, Magnetic resonance imaging, Vertigo
Clinical narrative: Vertigo,  treatment still ongoing
Age: 37.0
Sex: F
Vaccine: COVID19
Symptoms: Blood pressure increased, Heart rate increased, Palpitations
Clinical narrative: Hi I?m 37 years, old woman. My blood pressure raised from 120/80 to 133/92. I am experience a fast beating heart. Heart oalp. My next step is to go to the emergency room if my symptoms don?t absolve itself.  I am a healthy, normal weight woman. Others should know about these side effects
Age: 23.0
Sex: M
Vaccine: COVID19
Symptoms: Dizziness, Hyperhidrosis, Loss of consciousness, Syncope, Unresponsive to stimuli
Clinical narrative: Systemic: Fainting / Unresponsive-Mild, Additional Details: pt began feeling light headed about 5 minutes after recieving the vaccine. he began to get sweaty and loss of consciousness. i sat him down on the floor and gave him a water at which he immediately started feeling better. took pts bp: 115/76 hr:88 osat:99. pt felt perfectly fine after and at that point mentioned he didnt eat anything that day and fainted once giving blood. called pt couple hours later and stated that he felt perfectly fine;
Age: 50.0
Sex: F
Vaccine: COVID19
Symptoms: Axillary mass, Axillary pain, Paraesthesia
Clinical narrative: Left arm axillary pain with feeling of knot or lump there. Parasthesia down entire right arm to wrist and hand. It started the day after the vaccine and still present 2 days later (today).
Age: 16.0
Sex: F
Vaccine: COVID19
Symptoms: Product administered to patient of inappropriate age
Clinical narrative: Error: Patient too young for vaccine administered.
Age: 19.0
Sex: F
Vaccine: COVID19
Symptoms: Heart rate increased, Tachycardia
Clinical narrative: Systemic: Tachycardia-Mild, Additional Details: Patient called day after vaccine administration and stated that her smart watch alerted her to an elevated resting heart rate.  Patient stated that her resting heart rate had been at 120 bpm for over an hour.  She did not perform physical activity, was not experiencing anxiety, not contributed to any beverage or medication.  Advised patient to go to urgent care as she does not have a primary care physician at this time.
Age: 52.0
Sex: M
Vaccine: COVID19
Symptoms: Angiogram, Coronary arterial stent insertion, Myocardial infarction
Clinical narrative: Heart Attack -  2 day stay in the hospital. -  Stent placement in my heart. -  Now I'm on life long medication...
Age: 50.0
Sex: M
Vaccine: COVID19
Symptoms: Grip strength decreased, Injected limb mobility decreased, Injection site pain, Injection site swelling, Loss of personal independence in daily activities
Clinical narrative: Site: Pain at Injection Site-Severe, Site: Swelling at Injection Site-Mild, Additional Details: Patient states that his arm was sore the day after the shot and has gotten increasingly painful since receiving.  He states that he can't raise his arm above his head or carry normal items without dropping them due to weakness in the arm.  He is experiencing difficulty doing daily tasks.
Age: 50.0
Sex: M
Vaccine: COVID19
Symptoms: Muscular weakness, Pain in extremity
Clinical narrative: Site: Pain at Injection Site-Severe, Site: Swelling at Injection Site-Mild, Additional Details: Patient states that his arm was sore the day after the shot and has gotten increasingly painful since receiving.  He states that he can't raise his arm above his head or carry normal items without dropping them due to weakness in the arm.  He is experiencing difficulty doing daily tasks.
Age: 23.0
Sex: M
Vaccine: COVID19
Symptoms: Chills, Confusional state, Dizziness, Flushing, Hyperhidrosis
Clinical narrative: Systemic: Chills-Mild, Systemic: Confusion-Mild, Systemic: Dizziness / Lightheadness-Medium, Systemic: Fainting / Unresponsive-Mild, Systemic: eye pupile was dialated-Mild, Systemic: Flushed / Sweating-Mild, Systemic: Tachycardia-Mild, Additional Details: pt got these symtops for about 10 mints then the ambulance came. after min he was good. they checked him with no any issues
Age: 23.0
Sex: M
Vaccine: COVID19
Symptoms: Mydriasis, Syncope, Tachycardia, Unresponsive to stimuli
Clinical narrative: Systemic: Chills-Mild, Systemic: Confusion-Mild, Systemic: Dizziness / Lightheadness-Medium, Systemic: Fainting / Unresponsive-Mild, Systemic: eye pupile was dialated-Mild, Systemic: Flushed / Sweating-Mild, Systemic: Tachycardia-Mild, Additional Details: pt got these symtops for about 10 mints then the ambulance came. after min he was good. they checked him with no any issues
Age: 87.0
Sex: M
Vaccine: COVID19
Symptoms: Chills, Cough, Dyspnoea, Fatigue, Myalgia
Clinical narrative: Case had symptom onset 7/30/21 which included subjective fever, chills, muscle aches, runny nose, sore throat, fatigue, cough, wheezing and shortness of breath. He was still symptomatic at time of case investigation on 8/2/2021. He was seen in the ER department and tested for Covid 19.
Age: 87.0
Sex: M
Vaccine: COVID19
Symptoms: Oropharyngeal pain, Pyrexia, Rhinorrhoea, SARS-CoV-2 test, Wheezing
Clinical narrative: Case had symptom onset 7/30/21 which included subjective fever, chills, muscle aches, runny nose, sore throat, fatigue, cough, wheezing and shortness of breath. He was still symptomatic at time of case investigation on 8/2/2021. He was seen in the ER department and tested for Covid 19.
Age: 12.0
Sex: M
Vaccine: COVID19
Symptoms: Product administered to patient of inappropriate age
Clinical narrative: Error: Patient Too Young for Vaccine Administered-
Age: 19.0
Sex: M
Vaccine: COVID19
Symptoms: Balance disorder, Dyspnoea, Loss of consciousness
Clinical narrative: The patient was sitting in the observation area with his mother, when he began to feel short of breath and unexpectedly lost consciousness. The mother said he "slumped down in his chair". He came to within a minute, was laid down (and 911 was called immediately). He said he has never passed out from a vaccine before, but not longer felts out of breath or any other symptoms. A pharmacist (myself) retrieved a nurse and PA from the clinic across the hall who monitored the patient, who then had normal vitals. He denied the ambulance when they arrived and eventually left on his own accord.
Age: 19.0
Sex: M
Vaccine: COVID19
Symptoms: Syncope, Unresponsive to stimuli
Clinical narrative: Systemic: Fainting / Unresponsive-Mild
Age: 35.0
Sex: M
Vaccine: COVID19
Symptoms: Loss of consciousness, Syncope
Clinical narrative: Systemic: Fainting / Unresponsive-Mild
Age: 44.0
Sex: F
Vaccine: COVID19
Symptoms: Cough, Dyspnoea, Fatigue, Headache, Myalgia
Clinical narrative: Case symptom onset 8/1/21 which included subjective fever, muscle aches, sore throat, olfactory disorders, headache, fatigue, cough, shortness of breath and congestion. Case was not tested for Covid 19 but contact tracer treated as a positive case due to symptoms and 2 household contacts who had tested positive for Covid19.
Age: 44.0
Sex: F
Vaccine: COVID19
Symptoms: Olfactory nerve disorder, Oropharyngeal pain, Pyrexia, Respiratory tract congestion
Clinical narrative: Case symptom onset 8/1/21 which included subjective fever, muscle aches, sore throat, olfactory disorders, headache, fatigue, cough, shortness of breath and congestion. Case was not tested for Covid 19 but contact tracer treated as a positive case due to symptoms and 2 household contacts who had tested positive for Covid19.
Age: 16.0
Sex: M
Vaccine: COVID19
Symptoms: Asthenia, Chills, Confusional state, Flushing, Hyperhidrosis
Clinical narrative: Systemic: Chills-Mild, Systemic: Confusion-Severe, Systemic: Fainting / Unresponsive-Severe, Systemic: Flushed / Sweating-Mild, Systemic: Hypotension-Severe, Systemic: Nausea-Mild, Systemic: Shakiness-Mild, Systemic: Weakness-Medium, Additional Details: pt was  fainting and failing right after he received pfizer.  he hit very hard on the registor counter.  He look so very pale and fainted. He had low blood pressure, 106/60.  He had the same symptoms on the first short. He was given water.  Paramedic came and checked him up.  Mon refuse to take him to hospital. Paramedic leave it up to mon to get check out with his PCP.  She states that he does not have PCP.
Age: 16.0
Sex: M
Vaccine: COVID19
Symptoms: Hypotension, Immediate post-injection reaction, Nausea, Pallor, Syncope
Clinical narrative: Systemic: Chills-Mild, Systemic: Confusion-Severe, Systemic: Fainting / Unresponsive-Severe, Systemic: Flushed / Sweating-Mild, Systemic: Hypotension-Severe, Systemic: Nausea-Mild, Systemic: Shakiness-Mild, Systemic: Weakness-Medium, Additional Details: pt was  fainting and failing right after he received pfizer.  he hit very hard on the registor counter.  He look so very pale and fainted. He had low blood pressure, 106/60.  He had the same symptoms on the first short. He was given water.  Paramedic came and checked him up.  Mon refuse to take him to hospital. Paramedic leave it up to mon to get check out with his PCP.  She states that he does not have PCP.
Age: 16.0
Sex: M
Vaccine: COVID19
Symptoms: Tremor, Unresponsive to stimuli
Clinical narrative: Systemic: Chills-Mild, Systemic: Confusion-Severe, Systemic: Fainting / Unresponsive-Severe, Systemic: Flushed / Sweating-Mild, Systemic: Hypotension-Severe, Systemic: Nausea-Mild, Systemic: Shakiness-Mild, Systemic: Weakness-Medium, Additional Details: pt was  fainting and failing right after he received pfizer.  he hit very hard on the registor counter.  He look so very pale and fainted. He had low blood pressure, 106/60.  He had the same symptoms on the first short. He was given water.  Paramedic came and checked him up.  Mon refuse to take him to hospital. Paramedic leave it up to mon to get check out with his PCP.  She states that he does not have PCP.
Age: 12.0
Sex: F
Vaccine: COVID19
Symptoms: Chills, Fatigue, Headache, Nausea, Pyrexia
Clinical narrative: Vaccine recieved at 11:45am. Symptoms started same day at 3pm. Symptoms include, fever, chills, vomitting, fatigue, headache, nausea. She also started her period 2 days after vaccine, which she had already had that month. Still experiencing all the above Symptoms, after 1 week of vaccine.
Age: 12.0
Sex: F
Vaccine: COVID19
Symptoms: Vomiting
Clinical narrative: Vaccine recieved at 11:45am. Symptoms started same day at 3pm. Symptoms include, fever, chills, vomitting, fatigue, headache, nausea. She also started her period 2 days after vaccine, which she had already had that month. Still experiencing all the above Symptoms, after 1 week of vaccine.
Age: 13.0
Sex: M
Vaccine: COVID19
Symptoms: Tremor
Clinical narrative: Systemic: Shakiness-Severe, Additional Details: patient had shakiness. He said he was very nervous and anxious about vaccination. He sat for few mins was given water and candy. He wanted to stand outside for few mins and felt better was feeling better when he went outside.
Age: 17.0
Sex: M
Vaccine: COVID19
Symptoms: Flushing, Hyperhidrosis, Injection site swelling, Syncope, Unresponsive to stimuli
Clinical narrative: Site: Swelling at Injection Site-Mild, Systemic: Fainting/Unresponsive-Mild, Systemic: Flushed/Sweating-Mild.
Age: 63.0
Sex: F
Vaccine: COVID19
Symptoms: Amnesia, Fatigue, Headache
Clinical narrative: NEXT DAY STARTED WITH A SLIGHT HEADACHE, MEMORY LOSS, VERY TIRED. AND STILL HAVE THESE
Age: 41.0
Sex: M
Vaccine: COVID19
Symptoms: COVID-19, Cough, Headache, SARS-CoV-2 test positive
Clinical narrative: Case symptom onset 7/29/2021 which included headache and  cough. He was tested by Rapid Antigen on 8/1/2021 and tested positive for Covid 19. At the time of case investigation 8/1/21 case was still symptomatic.
Age: 47.0
Sex: M
Vaccine: COVID19
Symptoms: Incorrect product formulation administered, Interchange of vaccine products
Clinical narrative: Error: Wrong Vaccine Formulation  (ex. different manufact. initial and booster)-
Age: 80.0
Sex: M
Vaccine: COVID19
Symptoms: Extra dose administered
Clinical narrative: Error: Wrong Dose of Vaccine - Too High-
Age: 55.0
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, Chills, Diarrhoea, Fatigue, Headache
Clinical narrative: Case symptom onset 7/26/21 which included subjective fever, chills, runny  nose, sore throat, olfactory disorders, headache, fatigue and diarrhea. Case was Rapid Antigen tested for Covid 19 on 7/30/21 and was determined to be positive.
Age: 55.0
Sex: F
Vaccine: COVID19
Symptoms: Oropharyngeal pain, Parosmia, Pyrexia, Rhinorrhoea, SARS-CoV-2 test positive
Clinical narrative: Case symptom onset 7/26/21 which included subjective fever, chills, runny  nose, sore throat, olfactory disorders, headache, fatigue and diarrhea. Case was Rapid Antigen tested for Covid 19 on 7/30/21 and was determined to be positive.
Age: 19.0
Sex: F
Vaccine: COVID19
Symptoms: Hypotension, Syncope, Unresponsive to stimuli
Clinical narrative: Systemic: Fainting / Unresponsive-Medium, Additional Details: patient fainted after administration of vaccine. nurse practioner on site helped her to feet and monitored vitals. low blood pressure. patient was fine after 15 min
Age: 60.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Anticoagulant therapy, Balance disorder, Blood pressure increased, CSF protein increased, Computerised tomogram head normal
Clinical narrative: On Wed., July 14, my left hand started tingling. As the morning progressed, my hand and arm started feeling numb. Mid-afternoon, my left foot began feeling numb; the numbness spread up my entire leg. By the time I got home (6 pm), I needed assistance to get into the house, because my left leg wasn?t working and my foot was dragging. On Thursday July 15, I went to a local clinic; they immediately sent me to the ER. I was then transported to the ER, where I was admitted. Over the next five days I had CT scans of head, neck and spine; MRI?s of the same; a lumbar puncture; and an echocardiogram. I was given acyclovir; solumedrol; and heparin and amlodipine because my BP was elevated (180/100 Thursday afternoon). With the help of a physical therapist and a walker, I was able to get around, and my balance and stability improved, although the numbness in my arm and leg remained. At discharge, I was given a walker and an AFO brace to assist my walking. I was unable to return to work until August 4, 2021.
Age: 60.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Computerised tomogram spine, Computerised tomogram thorax, Echocardiogram, Gait disturbance, Hypoaesthesia
Clinical narrative: On Wed., July 14, my left hand started tingling. As the morning progressed, my hand and arm started feeling numb. Mid-afternoon, my left foot began feeling numb; the numbness spread up my entire leg. By the time I got home (6 pm), I needed assistance to get into the house, because my left leg wasn?t working and my foot was dragging. On Thursday July 15, I went to a local clinic; they immediately sent me to the ER. I was then transported to the ER, where I was admitted. Over the next five days I had CT scans of head, neck and spine; MRI?s of the same; a lumbar puncture; and an echocardiogram. I was given acyclovir; solumedrol; and heparin and amlodipine because my BP was elevated (180/100 Thursday afternoon). With the help of a physical therapist and a walker, I was able to get around, and my balance and stability improved, although the numbness in my arm and leg remained. At discharge, I was given a walker and an AFO brace to assist my walking. I was unable to return to work until August 4, 2021.
Age: 60.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Impaired work ability, Lumbar puncture, Magnetic resonance imaging head normal, Magnetic resonance imaging spinal abnormal, Magnetic resonance imaging thoracic
Clinical narrative: On Wed., July 14, my left hand started tingling. As the morning progressed, my hand and arm started feeling numb. Mid-afternoon, my left foot began feeling numb; the numbness spread up my entire leg. By the time I got home (6 pm), I needed assistance to get into the house, because my left leg wasn?t working and my foot was dragging. On Thursday July 15, I went to a local clinic; they immediately sent me to the ER. I was then transported to the ER, where I was admitted. Over the next five days I had CT scans of head, neck and spine; MRI?s of the same; a lumbar puncture; and an echocardiogram. I was given acyclovir; solumedrol; and heparin and amlodipine because my BP was elevated (180/100 Thursday afternoon). With the help of a physical therapist and a walker, I was able to get around, and my balance and stability improved, although the numbness in my arm and leg remained. At discharge, I was given a walker and an AFO brace to assist my walking. I was unable to return to work until August 4, 2021.
Age: 60.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Monoplegia, Orthosis user, Paraesthesia, Respiratory viral panel, Scan with contrast abnormal
Clinical narrative: On Wed., July 14, my left hand started tingling. As the morning progressed, my hand and arm started feeling numb. Mid-afternoon, my left foot began feeling numb; the numbness spread up my entire leg. By the time I got home (6 pm), I needed assistance to get into the house, because my left leg wasn?t working and my foot was dragging. On Thursday July 15, I went to a local clinic; they immediately sent me to the ER. I was then transported to the ER, where I was admitted. Over the next five days I had CT scans of head, neck and spine; MRI?s of the same; a lumbar puncture; and an echocardiogram. I was given acyclovir; solumedrol; and heparin and amlodipine because my BP was elevated (180/100 Thursday afternoon). With the help of a physical therapist and a walker, I was able to get around, and my balance and stability improved, although the numbness in my arm and leg remained. At discharge, I was given a walker and an AFO brace to assist my walking. I was unable to return to work until August 4, 2021.
Age: 60.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Spinal osteoarthritis, Stenosis, Walking aid user
Clinical narrative: On Wed., July 14, my left hand started tingling. As the morning progressed, my hand and arm started feeling numb. Mid-afternoon, my left foot began feeling numb; the numbness spread up my entire leg. By the time I got home (6 pm), I needed assistance to get into the house, because my left leg wasn?t working and my foot was dragging. On Thursday July 15, I went to a local clinic; they immediately sent me to the ER. I was then transported to the ER, where I was admitted. Over the next five days I had CT scans of head, neck and spine; MRI?s of the same; a lumbar puncture; and an echocardiogram. I was given acyclovir; solumedrol; and heparin and amlodipine because my BP was elevated (180/100 Thursday afternoon). With the help of a physical therapist and a walker, I was able to get around, and my balance and stability improved, although the numbness in my arm and leg remained. At discharge, I was given a walker and an AFO brace to assist my walking. I was unable to return to work until August 4, 2021.