chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 54.0
Sex: F
Vaccine: COVID19
Symptoms: Headache, Malaise, Nausea, Pyrexia, Respiratory tract irritation
Clinical narrative: not feeling well; Cough; My lungs feel like fine ,I can hold my breath for a long time .It is a kind of irrritation there.; Could not drink or eat anything; Vomited; when I close my eyes I was seeing weird stuff (people, monsters), it felt like I was hallucinating; Fever; Headache; Little of nausea; dry cough; feeling washed out; Chills; This spontaneous case was reported by a consumer and describes the occurrence of HALLUCINATION (when I close my eyes I was seeing weird stuff (people, monsters), it felt like I was hallucinating) in a 54-year-old female patient who received mRNA-1273  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 medical history reported).    On 13-Mar-2021, the patient received first dose of mRNA-1273  (Intramuscular) 1 dosage form. On 15-Mar-2021, the patient experienced CHILLS (Chills). On 16-Mar-2021, the patient experienced HALLUCINATION (when I close my eyes I was seeing weird stuff (people, monsters), it felt like I was hallucinating) (seriousness criterion medically significant), COUGH (dry cough), ASTHENIA (feeling washed out), PYREXIA (Fever), HEADACHE (Headache) and NAUSEA (Little of nausea). On 17-Mar-2021, the patient experienced DECREASED APPETITE (Could not drink or eat anything) and VOMITING (Vomited). On 19-Mar-2021, the patient experienced COUGH (Cough) and RESPIRATORY TRACT IRRITATION (My lungs feel like fine ,I can hold my breath for a long time .It is a kind of irrritation there.). On an unknown date, the patient experienced MALAISE (not feeling well). On 18-Mar-2021, VOMITING (Vomited) had not resolved. On 23-Mar-2021, CHILLS (Chills), PYREXIA (Fever), HEADACHE (Headache) and NAUSEA (Little of nausea) had resolved. At the time of the report, HALLUCINATION (when I close my eyes I was seeing weird stuff (people, monsters), it felt like I was hallucinating), MALAISE (not feeling well), DECREASED APPETITE (Could not drink or eat anything) and ASTHENIA (feeling washed out) outcome was unknown and COUGH (Cough), RESPIRATORY TRACT IRRITATION (My lungs feel like fine ,I can hold my breath for a long time .It is a kind of irrritation there.) and COUGH (dry cough) had not resolved.        The action taken with mRNA-1273 (Intramuscular) was unknown.       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.   Most recent FOLLOW-UP information incorporated above includes: On 29-Mar-2021: Outcome of the events included nausea, headache, fever, chills were updated as recovered on 23-Mar-2021. Dry cough was added as new event.; 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.
Age: 54.0
Sex: F
Vaccine: COVID19
Symptoms: Vomiting
Clinical narrative: not feeling well; Cough; My lungs feel like fine ,I can hold my breath for a long time .It is a kind of irrritation there.; Could not drink or eat anything; Vomited; when I close my eyes I was seeing weird stuff (people, monsters), it felt like I was hallucinating; Fever; Headache; Little of nausea; dry cough; feeling washed out; Chills; This spontaneous case was reported by a consumer and describes the occurrence of HALLUCINATION (when I close my eyes I was seeing weird stuff (people, monsters), it felt like I was hallucinating) in a 54-year-old female patient who received mRNA-1273  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 medical history reported).    On 13-Mar-2021, the patient received first dose of mRNA-1273  (Intramuscular) 1 dosage form. On 15-Mar-2021, the patient experienced CHILLS (Chills). On 16-Mar-2021, the patient experienced HALLUCINATION (when I close my eyes I was seeing weird stuff (people, monsters), it felt like I was hallucinating) (seriousness criterion medically significant), COUGH (dry cough), ASTHENIA (feeling washed out), PYREXIA (Fever), HEADACHE (Headache) and NAUSEA (Little of nausea). On 17-Mar-2021, the patient experienced DECREASED APPETITE (Could not drink or eat anything) and VOMITING (Vomited). On 19-Mar-2021, the patient experienced COUGH (Cough) and RESPIRATORY TRACT IRRITATION (My lungs feel like fine ,I can hold my breath for a long time .It is a kind of irrritation there.). On an unknown date, the patient experienced MALAISE (not feeling well). On 18-Mar-2021, VOMITING (Vomited) had not resolved. On 23-Mar-2021, CHILLS (Chills), PYREXIA (Fever), HEADACHE (Headache) and NAUSEA (Little of nausea) had resolved. At the time of the report, HALLUCINATION (when I close my eyes I was seeing weird stuff (people, monsters), it felt like I was hallucinating), MALAISE (not feeling well), DECREASED APPETITE (Could not drink or eat anything) and ASTHENIA (feeling washed out) outcome was unknown and COUGH (Cough), RESPIRATORY TRACT IRRITATION (My lungs feel like fine ,I can hold my breath for a long time .It is a kind of irrritation there.) and COUGH (dry cough) had not resolved.        The action taken with mRNA-1273 (Intramuscular) was unknown.       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.   Most recent FOLLOW-UP information incorporated above includes: On 29-Mar-2021: Outcome of the events included nausea, headache, fever, chills were updated as recovered on 23-Mar-2021. Dry cough was added as new event.; 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.
Sex: F
Vaccine: COVID19
Symptoms: Abdominal discomfort, Dizziness, Hypersensitivity, Hypotension, Loss of consciousness
Clinical narrative: passes out/unconscious; dizzy; sick to her stomach; very strange taste in her mouth/ thinking her mouth is bleeding, it tasted like blood; Allergic reaction; oxygen level was low; Blood pressure low; nauseas; This spontaneous case was reported by a consumer (subsequently medically confirmed) and describes the occurrence of LOSS OF CONSCIOUSNESS (passes out/unconscious) in a 120-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 39A21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     Concurrent medical conditions included Penicillin allergy.    On 31-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 31-Mar-2021, the patient experienced LOSS OF CONSCIOUSNESS (passes out/unconscious) (seriousness criterion medically significant), DIZZINESS (dizzy), ABDOMINAL DISCOMFORT (sick to her stomach), TASTE DISORDER (very strange taste in her mouth/ thinking her mouth is bleeding, it tasted like blood), HYPERSENSITIVITY (Allergic reaction), OXYGEN SATURATION DECREASED (oxygen level was low), HYPOTENSION (Blood pressure low) and NAUSEA (nauseas). At the time of the report, LOSS OF CONSCIOUSNESS (passes out/unconscious), DIZZINESS (dizzy), ABDOMINAL DISCOMFORT (sick to her stomach), TASTE DISORDER (very strange taste in her mouth/ thinking her mouth is bleeding, it tasted like blood), HYPERSENSITIVITY (Allergic reaction), OXYGEN SATURATION DECREASED (oxygen level was low), HYPOTENSION (Blood pressure low) and NAUSEA (nauseas) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       concomitant medication not provided. Treatment included Intravenous (IV) fluid; 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.
Sex: F
Vaccine: COVID19
Symptoms: Nausea, Oxygen saturation decreased, Taste disorder
Clinical narrative: passes out/unconscious; dizzy; sick to her stomach; very strange taste in her mouth/ thinking her mouth is bleeding, it tasted like blood; Allergic reaction; oxygen level was low; Blood pressure low; nauseas; This spontaneous case was reported by a consumer (subsequently medically confirmed) and describes the occurrence of LOSS OF CONSCIOUSNESS (passes out/unconscious) in a 120-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 39A21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     Concurrent medical conditions included Penicillin allergy.    On 31-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 31-Mar-2021, the patient experienced LOSS OF CONSCIOUSNESS (passes out/unconscious) (seriousness criterion medically significant), DIZZINESS (dizzy), ABDOMINAL DISCOMFORT (sick to her stomach), TASTE DISORDER (very strange taste in her mouth/ thinking her mouth is bleeding, it tasted like blood), HYPERSENSITIVITY (Allergic reaction), OXYGEN SATURATION DECREASED (oxygen level was low), HYPOTENSION (Blood pressure low) and NAUSEA (nauseas). At the time of the report, LOSS OF CONSCIOUSNESS (passes out/unconscious), DIZZINESS (dizzy), ABDOMINAL DISCOMFORT (sick to her stomach), TASTE DISORDER (very strange taste in her mouth/ thinking her mouth is bleeding, it tasted like blood), HYPERSENSITIVITY (Allergic reaction), OXYGEN SATURATION DECREASED (oxygen level was low), HYPOTENSION (Blood pressure low) and NAUSEA (nauseas) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       concomitant medication not provided. Treatment included Intravenous (IV) fluid; 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: 82.0
Sex: F
Vaccine: COVID19
Symptoms: Abdominal pain upper, Hepatic enzyme increased, Laboratory test
Clinical narrative: elevated/abnormal liver enzymes; epigastric pain; This spontaneous case was reported by a nurse (subsequently medically confirmed) and describes the occurrence of HEPATIC ENZYME INCREASED (elevated/abnormal liver enzymes) and ABDOMINAL PAIN UPPER (epigastric pain) in an 82-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 027B21A and 032M20A) for COVID-19 vaccination.     The patient's past medical history included COVID-19 (in Nov or Dec 2020) in 2020.   On 08-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 08-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 10-Apr-2021, the patient experienced HEPATIC ENZYME INCREASED (elevated/abnormal liver enzymes) (seriousness criterion hospitalization) and ABDOMINAL PAIN UPPER (epigastric pain) (seriousness criterion hospitalization). The patient was hospitalized on 10-Apr-2021 due to ABDOMINAL PAIN UPPER and HEPATIC ENZYME INCREASED. At the time of the report, HEPATIC ENZYME INCREASED (elevated/abnormal liver enzymes) and ABDOMINAL PAIN UPPER (epigastric pain) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 10-Apr-2021, Laboratory test: elevated lver enzymes (High) elevated liver enzymes.     For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   Concomitant product use was not provided. On 10 Apr 2021, the patient visited a hospital with epigastric pain.  Diagnostic testing revealed elevated liver enzymes.  The patient was transferred to a different medical center due to the abnormal liver enzymes and admitted for more diagnostic testing.  Diagnostic tests at this medical center also revealed elevated liver enzymes. Treatment information was not provided.  Very limited information regarding these events has been provided at this time.  Further information has been requested.; Sender's Comments: Very limited information regarding these events has been provided at this time.  Further information has been requested.
Age: 63.0
Sex: F
Vaccine: COVID19
Symptoms: Arthralgia, Inflammation, Pain, Product dose omission issue
Clinical narrative: Severe pain on her body; she did not complete the vaccination series; hair, joints and body were painful; inflammatory reaction to the vaccine; This spontaneous case was reported by a consumer (subsequently medically confirmed) and describes the occurrence of PAIN (Severe pain on her body) in a 63-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     Concurrent medical conditions included Drug allergy (Cephalosporins Allergy), Drug allergy (Relphen Allergy), Drug allergy (Celebrex Allergy) and Autoimmune disorder (5 autoimmune disorders; no additional information provided). Concomitant products included DULOXETINE HYDROCHLORIDE (CYMBALTA), DOXEPIN, LEVOTHYROXINE SODIUM (LEVOXYL), INSULIN GLARGINE (LANTUS), IRON, RAMIPRIL, VITAMIN D [VITAMIN D NOS], ATORVASTATIN, KRILL OIL, ACETYLSALICYLIC ACID (BABY ASPIRIN), LIDOCAINE, IBUPROFEN, CYANOCOBALAMIN (B 12), INSULIN ASPART (NOVOLOG), CLARITHROMYCIN (CLARITIN [CLARITHROMYCIN]) and ARIPIPRAZOLE for an unknown indication.    On 26-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 27-Feb-2021, the patient experienced PAIN (Severe pain on her body) (seriousness criterion hospitalization) and INFLAMMATION (inflammatory reaction to the vaccine). On an unknown date, the patient experienced PRODUCT DOSE OMISSION ISSUE (she did not complete the vaccination series) and ARTHRALGIA (hair, joints and body were painful). At the time of the report, PAIN (Severe pain on her body), INFLAMMATION (inflammatory reaction to the vaccine), PRODUCT DOSE OMISSION ISSUE (she did not complete the vaccination series) and ARTHRALGIA (hair, joints and body were painful) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Treatment drugs reported includes Ibuprofen every 6 hours.  She was hospitalized for one day, she does not remember the date but she thinks it was 28Feb2021. At the ER the doctor gave her an injection of a narcotic pain medicine. She was discharged from hospital to take Ibuprofen. She is taking Ibuprofen every 6 hours now.  Based on current available information and the temporal association between product and the start date of the events a causal relationship cannot be excluded.   QUALITY-SAFETY EVALUATION OF PTC: BID; Sender's Comments: Based on current available information and the temporal association between product and the start date of the events a causal relationship cannot be excluded.
Age: 36.0
Sex: M
Vaccine: COVID19
Symptoms: Appendicitis, Computerised tomogram
Clinical narrative: Appendicitis
Age: 52.0
Sex: F
Vaccine: COVID19
Symptoms: Blood pressure decreased, Blood pressure measurement, Dizziness, Dyspnoea, Feeling cold
Clinical narrative: Vomited, nauseated, dizzy, shortness of breath, cold, drop in BP 99/70. Laid patient down, took BP, wait 5 minutes, gave water and called ambulance.
Age: 52.0
Sex: F
Vaccine: COVID19
Symptoms: Nausea, Vomiting
Clinical narrative: Vomited, nauseated, dizzy, shortness of breath, cold, drop in BP 99/70. Laid patient down, took BP, wait 5 minutes, gave water and called ambulance.
Sex: F
Vaccine: COVID19
Symptoms: Cardiac arrest, Pulmonary embolism, Respiratory distress
Clinical narrative: respiratory distress; cardiac arrest; pulmonary emboliasm; This spontaneous case was reported by a consumer and describes the occurrence of RESPIRATORY DISTRESS (respiratory distress), CARDIAC ARREST (cardiac arrest) and PULMONARY EMBOLISM (pulmonary emboliasm) in a 76-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     Concurrent medical conditions included Lipid metabolism disorder NOS.  On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 08-Apr-2021, the patient experienced RESPIRATORY DISTRESS (respiratory distress) (seriousness criterion death), CARDIAC ARREST (cardiac arrest) (seriousness criterion death) and PULMONARY EMBOLISM (pulmonary emboliasm) (seriousness criterion death). The patient died on 11-Apr-2021. It is unknown if an autopsy was performed. Not Provided    For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   NO treatment or Concomitant medication were provided.  Company Comment  This is a case of sudden death in a 76-year-old female patient with a history of Lipid metabolism disorder, who died (date unknown) of respiratory distress, cardiac arrest and PULMONARY EMBOLISM after receiving first dose of vaccine. Very limited information has been provided at this time.
Age: 29.0
Sex: F
Vaccine: COVID19
Symptoms: Head discomfort, Headache, Magnetic resonance imaging head, Menstruation delayed
Clinical narrative: I started with the headache the day after the first dose of moderna vaccine. Since then and until today 18 days later it has not been taken away from me and it has been changing. Sometimes they are punctures, sometimes pangs that come and go and sometimes constant pressure. Also my period is 11 days late, which has never happened to me, it is usually early.
Age: 62.0
Sex: F
Vaccine: COVID19
Symptoms: Acoustic stimulation tests, Rosacea, Tinnitus
Clinical narrative: High-pitched hissing Tinnitus (both ears) with intermittent bouts of very loud lower pitched tinnitus in one ear or the other.  Exacerbated rosacea.
Age: 55.0
Sex: F
Vaccine: COVID19
Symptoms: Asthenia, Dyspnoea, Feeling cold, Headache, Myalgia
Clinical narrative: Symptoms (has lasted more than a week) : muscle pain in the right side of the body from neck to the waist. Strengthless, hard to breath, headache. Feeling very cold.
Age: 24.0
Sex: M
Vaccine: COVID19
Symptoms: Pain in extremity, Pruritus, Skin warm, Swelling
Clinical narrative: Left pinky toe itchy and swollen/inflamed, sometimes hurts. It's been only a week so far, just started applying Cortizone.
Age: 62.0
Sex: F
Vaccine: COVID19
Symptoms: Anxiety, Asthenia, Dizziness, Headache, Paraesthesia
Clinical narrative: Within 5 minutes, I started to feel tingly all over my body, weak then shakey,  light headed then anxiety started to appear, couldn't take a deep breath, little dizzy.  I was able to walk, so I asked to see a Nurse.  I was taken to an area where I was given oxygen and rest.  My blood sugar was taken, per my request, it was (BG 160) I had eaten breakfast that morning.  I rested with oxygen for about 30 minutes, I felt an improvement, so Nurse asked to stand/walk slow...I did and got just a little dizzy, so I sat with oxygen for about another 20-25 minutes and decided to go home.  Nurse checked my oxygen level, she said it was 100% and my heart rate/pulse was 78.  I decided with the agreement of the Nurse, that I was was okay to go home and rest.  Upon arriving at home, I drank some water and rested.  My arm didn't hurt at all, until a few hours later and then for 1 day. I took a nap, when I awoke a had a slight headache, but was feeling much better, not dizzy, light headed and weakness was minimal, as well as shakiness was  minimal. Also,  a little taste at back of throat/sinus area, like a post nasal drip, kind of like when I go to the dentist. I never did take Benadryl. That strange sensation went away within the day.
Age: 62.0
Sex: F
Vaccine: COVID19
Symptoms: Taste disorder, Tremor
Clinical narrative: Within 5 minutes, I started to feel tingly all over my body, weak then shakey,  light headed then anxiety started to appear, couldn't take a deep breath, little dizzy.  I was able to walk, so I asked to see a Nurse.  I was taken to an area where I was given oxygen and rest.  My blood sugar was taken, per my request, it was (BG 160) I had eaten breakfast that morning.  I rested with oxygen for about 30 minutes, I felt an improvement, so Nurse asked to stand/walk slow...I did and got just a little dizzy, so I sat with oxygen for about another 20-25 minutes and decided to go home.  Nurse checked my oxygen level, she said it was 100% and my heart rate/pulse was 78.  I decided with the agreement of the Nurse, that I was was okay to go home and rest.  Upon arriving at home, I drank some water and rested.  My arm didn't hurt at all, until a few hours later and then for 1 day. I took a nap, when I awoke a had a slight headache, but was feeling much better, not dizzy, light headed and weakness was minimal, as well as shakiness was  minimal. Also,  a little taste at back of throat/sinus area, like a post nasal drip, kind of like when I go to the dentist. I never did take Benadryl. That strange sensation went away within the day.
Age: 64.0
Sex: F
Vaccine: COVID19
Symptoms: Chills, Peripheral swelling, Pyrexia, Rash, Skin warm
Clinical narrative: On the 8th day after 2nd vaccination Iran a fever of 101.5 with severe chills when the fever broke the next day 9 days after 2nd  vaccination my arm has developed Rash is hot to touch and slightly swollen
Age: 40.0
Sex: F
Vaccine: COVID19
Symptoms: Immediate post-injection reaction, Injection site pain, Injection site pruritus, Injection site reaction, Pain
Clinical narrative: The first injection in my left arm, I didn?t feel at all. Only a mild ache for a day resulted. This time was different. Immediately when the needle went in, it felt like a swarm of hornets stinging. The injection site itches and burned like poison ivy. By the next morning, I had a sizable red welt and it felt achey, as well as tender to the touch.
Age: 40.0
Sex: F
Vaccine: COVID19
Symptoms: Pain of skin, Tenderness, Urticaria
Clinical narrative: The first injection in my left arm, I didn?t feel at all. Only a mild ache for a day resulted. This time was different. Immediately when the needle went in, it felt like a swarm of hornets stinging. The injection site itches and burned like poison ivy. By the next morning, I had a sizable red welt and it felt achey, as well as tender to the touch.
Age: 40.0
Sex: F
Vaccine: COVID19
Symptoms: Arthralgia, Back pain, Heavy menstrual bleeding, Menstruation irregular
Clinical narrative: My first period after the vaccine arrived 6 days early, which is quite abnormal for me. The day before I couldn't work at my desk due to pain in my low back and hip flexors, which is also abnormal. Then the period was heavier than normal lasted 3 days longer than normal. It looked like there were clots in the blood.   I mentioned this experience to a friend, who said several of his female friends also experienced bizarre periods after receiving the JJ vaccine. Was this drug tested on women of reproductive age before being released?
Age: 30.0
Sex: F
Vaccine: COVID19
Symptoms: Thrombosis
Clinical narrative: blood clot on the left leg; blood clot on the right leg; This spontaneous case was reported by a consumer and describes the occurrence of THROMBOSIS (blood clot on the right leg) and THROMBOSIS (blood clot on the left leg) in a 30-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 038321A) for COVID-19 vaccination.     The patient's past medical history included No adverse event (no medical history reported).   On 11-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 08-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 05-Apr-2021, the patient experienced THROMBOSIS (blood clot on the right leg) (seriousness criterion medically significant). On 12-Apr-2021, the patient experienced THROMBOSIS (blood clot on the left leg) (seriousness criterion medically significant). At the time of the report, THROMBOSIS (blood clot on the right leg) and THROMBOSIS (blood clot on the left leg) outcome was unknown. Not Provided   The patient has not provided with any concomitant medication. No treatment medications are listed.  Company Comment  Based on the current available information which includes a strong temporal association between the use of mRNA-1273 vaccine and onset of the reported events, a causal relationship cannot be excluded.   This case was linked to US-MODERNATX, INC.-MOD-2021-043122 (E2B Linked Report).   Reporter did not allow further contact; Sender's Comments:  US-MODERNATX, INC.-MOD-2021-043122:1st dose
Age: 43.0
Sex: F
Vaccine: COVID19
Symptoms: Cyst, Erythema, Skin warm, Swelling
Clinical narrative: Cyst the size of a pea that I have had for over a year grew to the size of a grape and got red,  hot and uncomfortable four days after second vaccine dose. Swelling/redness has not decreased as of 11 days after second vaccine
Age: 17.0
Sex: F
Vaccine: COVID19
Symptoms: Anxiety, Blood pressure measurement, Cold sweat, Dizziness, Hypotension
Clinical narrative: COLD SWEATS, DIZZINESS, DROWSINESS, BP WAS TAKEN 74/44, THEN 5 MINS LATER 99/60, PT WAS LAID DOWN TO PREVENT FALLING, PT WAS NERVOUS AND ANXIOUS
Age: 17.0
Sex: F
Vaccine: COVID19
Symptoms: Nervousness, Somnolence
Clinical narrative: COLD SWEATS, DIZZINESS, DROWSINESS, BP WAS TAKEN 74/44, THEN 5 MINS LATER 99/60, PT WAS LAID DOWN TO PREVENT FALLING, PT WAS NERVOUS AND ANXIOUS
Age: 61.0
Sex: M
Vaccine: COVID19
Symptoms: Hypoaesthesia, Paraesthesia
Clinical narrative: Left hand (same arm as vaccine administered) completely numb. Can move fingers, but no feeling except constant tingling. Has persisted about a day now.
Age: 36.0
Sex: F
Vaccine: COVID19
Symptoms: Arthralgia, Chills, Fatigue, Myalgia, Pyrexia
Clinical narrative: Extreme cold chili?s, fever, extreme muscle and joint pain and fatigue
Age: 48.0
Sex: F
Vaccine: COVID19
Symptoms: Tinnitus
Clinical narrative: Tinnitus, gradually growing more intense as time goes on. It's a wavering, buzzing sound, like cicadas.
Age: 70.0
Sex: F
Vaccine: COVID19
Symptoms: Fatigue, Headache, Pain, Pyrexia
Clinical narrative: Fever, body aches, headache and fatigue.
Age: 63.0
Sex: F
Vaccine: COVID19
Symptoms: Diarrhoea, Taste disorder
Clinical narrative: After injection in automatic terrible taste in my mouth like I could taste the vaccine. Return  For 20 days experienced severe diarrhea morning noon and night.
Age: 66.0
Sex: M
Vaccine: COVID19
Symptoms: Cold sweat, Dizziness, Dyskinesia, Fall, Gaze palsy
Clinical narrative: Almost immediately  got 'woozy' and fell off the chair onto the floor. His eyes were glassy and his hands and arms were jerking.  He was able to get back up on  the chair and said that he was ok, but he looked pale and felt a little clammy. He sat on the chair and drank some water while we were waiting for the EMS. He said that he had breakfast but no lunch. While he was sitting on the chair his eyes glassed over again and he made some grunting sounds.  EMS came checked him out and said that his vitals where  okay, and he wanted to drive home which was 15 miles away.  The EMS  gave him a report as to what happened and his vitals incase  he needed to seek further medical attention.
Age: 29.0
Sex: F
Vaccine: COVID19
Symptoms: Hypersensitivity, Injection site rash, Pruritus, Rash, Rash pruritic
Clinical narrative: I had to go to the ER a few hours later due to having a rash spread over my entire upper torso from injection site and spreading over my body and under the skin with severe itching and burning. I received benadryl, solu-medrol, and plasma-lyte through IV catheter. Dr diagnosed it as an allergic reaction called Pruritis.
Age: 29.0
Sex: F
Vaccine: COVID19
Symptoms: Skin burning sensation
Clinical narrative: I had to go to the ER a few hours later due to having a rash spread over my entire upper torso from injection site and spreading over my body and under the skin with severe itching and burning. I received benadryl, solu-medrol, and plasma-lyte through IV catheter. Dr diagnosed it as an allergic reaction called Pruritis.
Age: 41.0
Sex: F
Vaccine: COVID19
Symptoms: Injection site erythema, Injection site pain, Injection site warmth
Clinical narrative: Delayed redness at injection site, approximately size of silver dollar. Area is warm and localized pain.
Age: 74.0
Sex: M
Vaccine: COVID19
Symptoms: Death, Respiratory arrest, Resuscitation
Clinical narrative: Died in sleep.  Not sick when he went to bed. Not breathing when found. No sign of puke, blood, urine or BM.
Age: 63.0
Sex: F
Vaccine: COVID19
Symptoms: Diabetic diet, Fatigue, Nausea, Ocular discomfort, Pruritus
Clinical narrative: 1st shot reactions Extreme Nausea; Extreme Fatigue --8 days later extreme itching on arms and welts--may have had an eye bleed; high eye pressure   Based on the extreme nausea and highly restricted diet--cut my basaglar units in half.  While i have returned to a diet at almost 80-85 percent; my insulin units remain  33% lower.  I wanted to report this finding bc I have not found any information to guide me on any diabetic effects.
Age: 63.0
Sex: F
Vaccine: COVID19
Symptoms: Urticaria
Clinical narrative: 1st shot reactions Extreme Nausea; Extreme Fatigue --8 days later extreme itching on arms and welts--may have had an eye bleed; high eye pressure   Based on the extreme nausea and highly restricted diet--cut my basaglar units in half.  While i have returned to a diet at almost 80-85 percent; my insulin units remain  33% lower.  I wanted to report this finding bc I have not found any information to guide me on any diabetic effects.
Age: 22.0
Sex: F
Vaccine: COVID19
Symptoms: Pyrexia
Clinical narrative: High fever
Age: 27.0
Sex: F
Vaccine: COVID19
Symptoms: Feeling cold, Limb discomfort, Mobility decreased
Clinical narrative: Pharmacist administered Moderna Covid-19 vaccine to patient and directed patient to the post-vaccine wait area for a 15min observation period. Once the 15min completed, cashier asked for a pharmacist to go over to patient as she had expressed discomfort on her left arm. Pharmacist was the first to tend to patient and alerted other pharmacist to follow up. Patient stated to pharmacist of discomfort and limited mobility of her left arm with a cold sensation extending from site of injection to her hand but not painful. Patient was asked to wait 15 minutes more to reassess for any improvement. At this point 30min had passed, patient expressed feeling some improvement but agreed to wait another 15min. Patient left on her own before the 3rd follow-up and did not check with any of the pharmacists on-site. Pharmacist called her and patient stated she had left the pharmacy because her arm was feeling better. She agreed for to follow-up with her at home on Monday 4/26/2021 and that if anything changed patient would call pharmacy on Saturday 4/24/2021 to check-in with pharmacist.
Age: 28.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Dizziness, Fatigue, Headache, Hyperhidrosis, Myalgia
Clinical narrative: Severe headaches and nausea, and lightheaded and also chills and sweating and arm pain and muscle aches and very tired.
Age: 28.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Nausea, Pain in extremity
Clinical narrative: Severe headaches and nausea, and lightheaded and also chills and sweating and arm pain and muscle aches and very tired.
Age: 70.0
Sex: F
Vaccine: COVID19
Symptoms: Computerised tomogram, Swelling face
Clinical narrative: right facial swelling; This spontaneous case was reported by a consumer and describes the occurrence of SWELLING FACE (right facial swelling) in a 70-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 0371-21B) for COVID-19 vaccination.     The patient's past medical history included No adverse event (No medical history reported. ).    On 25-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 26-Mar-2021, the patient experienced SWELLING FACE (right facial swelling) (seriousness criterion medically significant). At the time of the report, SWELLING FACE (right facial swelling) outcome was unknown. Not Provided    DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 08-Apr-2021, Computerised tomogram: inconclusive (Inconclusive) CAT scan did not say anything.     The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Concomitant product use was not provided by the reporter. No treatment information was provided.  This case concerns a 70-year-old female with a serious unexpected event of swelling face. Event onset 2 days after first dose mRNA-1273. Event outcome unknown. Based on 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: This case concerns a 70-year-old female with a serious unexpected event of swelling face. Event onset 2 days after first dose mRNA-1273. Event outcome unknown. Based on 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: 27.0
Sex: M
Vaccine: COVID19
Symptoms: Fall, Nausea, Syncope
Clinical narrative: PATIENT RECEIVED THE FIRST DOSE OF MODERNA COVID VACCINE AT APPROXIMATELY 1930. FIVE MINUTES OR SO PASSED. THE PATIENT CAME UP TO THE COUNTER AND EXPLAINED HE WAS FEELING "A LITTLE NAUSEOUS" AND ASKED TO LEAVE THE OBSERVATION AREA TO USE THE RESTROOM. BEFORE LEAVING THE COUNTER THE PATIENT FAINTED AND FELL TO THE FLOOR. THE PATIENT WAS QUICKLY AWAKE AND ALERT, ALTHOUGH RATTLED. HE APPEARED TO RECOVER NORMALLY AND REQUESTED TO NOT HAVE PARAMEDICS COME TO THE SCENE. HE WAS PLACED IN A CHAIR AND ASKED TO REMAIN IN THE OBSERVATION AREA FOR ADDITIONAL 15-20 MINUTES BEFORE LEAVING UNDER HIS OWN POWER.
Age: 39.0
Sex: F
Vaccine: COVID19
Symptoms: Arthralgia, Muscular weakness, Paraesthesia
Clinical narrative: One month after second shot: tingling in arms/hands and legs/feet, muscle weakness, joint pain
Age: 38.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: No adverse event
Clinical narrative: After recieving the second shot for my COVID19 vaccine, I breastfed my 14 month old twice and then he vomited. I continued to feed and breastfeed him as usual and later that night he vomited again. The only difference from the usual day that I could discern was the vaccine.
Age: 35.0
Sex: F
Vaccine: COVID19
Symptoms: Somnolence
Clinical narrative: Drowsiness
Age: 38.0
Sex: F
Vaccine: COVID19
Symptoms: Chills, Headache, Hyperhidrosis, Injection site induration, Injection site pain
Clinical narrative: 10 - 17 hours after: vaccine: frequent urination 7 times overnight, full bladder 17/18 hrs after vaccine: - severe headache, body aches, chills, fever 103.8, unable to sleep, frequent urination continued, 1-2 times per hour, full bladder. 34 hrs after: body aches, chills, and frequent urination subside. Body can?t cool down, really hot no matter what. Fever starts to drop. Sweat profusely overnight - soaking wet sheets.  42 hours after: severe headache still persists, fever down to 100.6, profuse sweat continues through day.  Injection site hot, hard, and tender.
Age: 38.0
Sex: F
Vaccine: COVID19
Symptoms: Injection site warmth, Pain, Pollakiuria, Pyrexia, Sleep disorder
Clinical narrative: 10 - 17 hours after: vaccine: frequent urination 7 times overnight, full bladder 17/18 hrs after vaccine: - severe headache, body aches, chills, fever 103.8, unable to sleep, frequent urination continued, 1-2 times per hour, full bladder. 34 hrs after: body aches, chills, and frequent urination subside. Body can?t cool down, really hot no matter what. Fever starts to drop. Sweat profusely overnight - soaking wet sheets.  42 hours after: severe headache still persists, fever down to 100.6, profuse sweat continues through day.  Injection site hot, hard, and tender.
Age: 52.0
Sex: M
Vaccine: COVID19
Symptoms: Swelling face
Clinical narrative: Swelling of face in location of facial fillers
Age: 49.0
Sex: M
Vaccine: COVID19
Symptoms: Carotid artery stenosis, Cerebral artery occlusion
Clinical narrative: 12mm segment of M2 branch L MCA completely occluded, mild stenosis bilateral ICAs, high grade stenosis L common carotid artery
Age: 59.0
Sex: F
Vaccine: COVID19
Symptoms: Fatigue
Clinical narrative: After 13 days I am still very tired.
Age: 32.0
Sex: F
Vaccine: COVID19
Symptoms: Asthenia, Dyspnoea, Fatigue, Lethargy, Seizure
Clinical narrative: Seizure; Weakness; Difficulty Breathing; tiredness; Lethargy; This spontaneous case was reported by a consumer and describes the occurrence of SEIZURE (Seizure) in a 32-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 030M20A) 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 medical history reported).   On 03-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 03-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 03-Mar-2021, the patient experienced LETHARGY (Lethargy). On an unknown date, the patient experienced SEIZURE (Seizure) (seriousness criterion medically significant), ASTHENIA (Weakness), DYSPNOEA (Difficulty Breathing) and FATIGUE (tiredness). At the time of the report, SEIZURE (Seizure), LETHARGY (Lethargy), ASTHENIA (Weakness), DYSPNOEA (Difficulty Breathing) and FATIGUE (tiredness) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) and mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Concomitant product use was not provided by the reporter. No treatment information was provided.  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 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.
Age: 52.0
Sex: M
Vaccine: COVID19
Symptoms: Muscle spasms, Tongue spasm, Toothache
Clinical narrative: Muscle spasm, twitching of the tongue, soreness in teeth/jaw.
Age: 46.0
Sex: F
Vaccine: COVID19
Symptoms: Tendon pain
Clinical narrative: Opposite arm of shot, tendon (inner arm) area has hurt
Age: 59.0
Sex: F
Vaccine: COVID19
Symptoms: Blood creatinine increased, Eye pain, Full blood count, Headache, Metabolic function test
Clinical narrative: Bad headache day after shot. Then headache came and went, not too bad until 4.21.21. Sharp pain behind right eye. Dr ran labs, and all look ok. But today, 2 weeks to the day of shot, my headache came roaring back ad bad as day 1. Most pain is behind forehead and eyes. Finally took advil...But pain is not gone. Worst pain is behind right eye. I've never had migraines before. I'm tired of the pain.
Age: 59.0
Sex: F
Vaccine: COVID19
Symptoms: Prothrombin time normal
Clinical narrative: Bad headache day after shot. Then headache came and went, not too bad until 4.21.21. Sharp pain behind right eye. Dr ran labs, and all look ok. But today, 2 weeks to the day of shot, my headache came roaring back ad bad as day 1. Most pain is behind forehead and eyes. Finally took advil...But pain is not gone. Worst pain is behind right eye. I've never had migraines before. I'm tired of the pain.
Age: 47.0
Sex: F
Vaccine: COVID19
Symptoms: Deafness, Lyme disease, Tinnitus
Clinical narrative: I developed tinnitus in both ears and some hearing loss.
Age: 15.0
Sex: F
Vaccine: COVID19
Symptoms: Product administered to patient of inappropriate age
Clinical narrative: Patient falsified their DOB in order to qualify for the vaccination. It was not discovered until billing their vaccine and the third party rejected based on invalid DOB. When we called the insurance, they said the patient was born in 2005 and not 2004 as stated on their consent form.
Age: 46.0
Sex: F
Vaccine: COVID19
Symptoms: Arthralgia, Chills, Pain, Pain in extremity, Peripheral swelling
Clinical narrative: I had arm sore, swollen, chills, body and joints ache and fever up to 100.3 F the second day after the 2nd Moderna shot. I took an Advil at the night of second day. Feel much better on the third day, then around lunchtime, I start experiencing some weird sounds in both my ears. Feel like the flight taking off or landing, so tried big inhale ,  swallow waters, but this swooshing sound keeps staying and ringing. So  I start google to see if anyone has similar experience, look like so, so want to report for other people awareness. I really hope this will go away tomorrow after a good night sleep.
Age: 46.0
Sex: F
Vaccine: COVID19
Symptoms: Pyrexia, Tinnitus
Clinical narrative: I had arm sore, swollen, chills, body and joints ache and fever up to 100.3 F the second day after the 2nd Moderna shot. I took an Advil at the night of second day. Feel much better on the third day, then around lunchtime, I start experiencing some weird sounds in both my ears. Feel like the flight taking off or landing, so tried big inhale ,  swallow waters, but this swooshing sound keeps staying and ringing. So  I start google to see if anyone has similar experience, look like so, so want to report for other people awareness. I really hope this will go away tomorrow after a good night sleep.
Age: 5.0
Sex: M
Vaccine: DTAP
Symptoms: Cough, Erythema, Furuncle, Pain, Pain in extremity
Clinical narrative: Left arm red, hot to touch, growing boil. My son reports pain in whole arm when raised.  Runny nose and cough. Drowsy.
Age: 5.0
Sex: M
Vaccine: DTAP
Symptoms: Rhinorrhoea, Skin warm, Somnolence
Clinical narrative: Left arm red, hot to touch, growing boil. My son reports pain in whole arm when raised.  Runny nose and cough. Drowsy.
Age: 18.0
Sex: F
Vaccine: COVID19
Symptoms: Aphasia, Cerebrovascular accident, Gait inability
Clinical narrative: Stroke/left side of the body; Can't talk; can't walk; This spontaneous case was reported by a non-health professional and describes the occurrence of CEREBROVASCULAR ACCIDENT (Stroke/left side of the body) in a 19-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 011J20A) 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 medical history reported).    On 31-Dec-2020, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 31-Dec-2020, the patient experienced CEREBROVASCULAR ACCIDENT (Stroke/left side of the body) (seriousness criteria disability and medically significant), APHASIA (Can't talk) and GAIT INABILITY (can't walk). At the time of the report, CEREBROVASCULAR ACCIDENT (Stroke/left side of the body), APHASIA (Can't talk) and GAIT INABILITY (can't walk) outcome was unknown. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown Route) was unknown.       There was no concomitant medications reported.  No treatment medications were provided.  Very limited information regarding these events has been provided at this time. Further information has been requested.   Reporter did not allow further contact; Sender's Comments: Very limited information regarding these events has been provided at this time. Further information has been requested.
Age: 25.0
Sex: F
Vaccine: COVID19
Symptoms: Dizziness, Loss of consciousness, Metamorphopsia, Muscle twitching, Seizure
Clinical narrative: While the patient was waiting, seated for 5 of the 15 minutes, post-vaccination she began to feel light headed. The patient shortly after expressing this concern slumped over in the chair, shaking and twitching, for a few moments (likely 60 seconds or less) before regaining normal stature and attention. The patient expressed some changes in her field of vision, a continuation of feeling light-headed, and a ringing in her ears.  EMS was called to evaluate the patient, concerned that the patient had experienced seizure activity. EMS arrived shortly after, evaluating the patient's current state and vitals. After assessment, EMS determined this was a syncopal episode related to the patient's anxiety around the vaccination and cleared the patient to drive themselves home after resting on-site. Patient rested and recovered in pharmacy vaccination room for an additional 20 minutes before leaving.
Age: 25.0
Sex: F
Vaccine: COVID19
Symptoms: Tinnitus, Tremor, Vital signs measurement
Clinical narrative: While the patient was waiting, seated for 5 of the 15 minutes, post-vaccination she began to feel light headed. The patient shortly after expressing this concern slumped over in the chair, shaking and twitching, for a few moments (likely 60 seconds or less) before regaining normal stature and attention. The patient expressed some changes in her field of vision, a continuation of feeling light-headed, and a ringing in her ears.  EMS was called to evaluate the patient, concerned that the patient had experienced seizure activity. EMS arrived shortly after, evaluating the patient's current state and vitals. After assessment, EMS determined this was a syncopal episode related to the patient's anxiety around the vaccination and cleared the patient to drive themselves home after resting on-site. Patient rested and recovered in pharmacy vaccination room for an additional 20 minutes before leaving.
Age: 42.0
Sex: F
Vaccine: COVID19
Symptoms: Blood test abnormal, Herpes zoster
Clinical narrative: Shingles
Age: 53.0
Sex: F
Vaccine: COVID19
Symptoms: Axillary pain, Chest pain, Fatigue, Headache
Clinical narrative: Instant upper chest pains and later armpit pain (lymph nodes.) Headaches and overly fatigued. Still in effect two weeks + later.
Age: 40.0
Sex: F
Vaccine: COVID19
Symptoms: Epistaxis
Clinical narrative: Nose bleed, mainly from the left nostril but also some coming from the right side.  I had been taking a nap in the afternoon.  I was asleep for approximately an hour on my left side, and woke up with blood dripping out of my nose.  I sat up and leaned my head forward while squeezing my nostrils together.  It took over an hour, and the blood was still coming any time I would lift my head.  My husband drove me to the nearest hospital.  By the time I arrived, the bleeding had stopped on its own. By then it had been approximately 90 minutes that my nose was bleeding.  I went into the Emergency Room and the physician assistant cleaned my nose, but she said she didn't think the nose bleed could be from the vaccine.  She didn't say why it couldn't be from the vaccine.  She suspected that my nose bleed could be from allergies and/or a mixture of sudden changes in temperature we have been having lately.  I reminded her I haven't had a nosebleed since I was a child.  However, she said that if it keeps happening then to see an Ear, Nose and Throat doctor.
Age: 65.0
Sex: F
Vaccine: COVID19
Symptoms: Chills, Headache, Myalgia, Nausea, Pyrexia
Clinical narrative: Chills, fever, muscle ache, nausea, headache for approximately 16 hours so far.
Age: 23.0
Sex: M
Vaccine: COVID19
Symptoms: Syncope
Clinical narrative: Patient was told to sit and wait for 15 minutes in waiting area but his mother called him over to the pharmacy to schedule his 2nd dose appointment. As he stood there, he fainted in front of the pharmacy. Pharmacy staff rushed over and provided care and store management was notified. He sat until he felt fine and was provided water and snacks. He left after ~20mins.
Age: 31.0
Sex: F
Vaccine: COVID19
Symptoms: Dizziness
Clinical narrative: During the 15 min. post-IMZ observation, patient complained of dizziness, light-headedness. She proceeds to rest on the floor. She was given some water and an ice-pack for the shoulder.  Her blood pressure was checked.  68bpm  <120/<80. She rested for another 5-7 minutes sitting on the chair until she was  fine again.