chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 44.0
Sex: M
Vaccine: COVID19
Symptoms: Arthralgia, Asthenia, Hypoaesthesia, Injection site pain, Malaise
Clinical narrative: had pain in left arm at injection site, but expected that. got sick after second dose (which is strange as I got really sick after the first one), that went away after roughly 36 hrs, however the injection site pain had radiated down the left arm. still, just assumed it'd go away, no worries. woke up the second day after shot, with feeling as if id maybe slept funny, as my shoulder on the left arm had a shooting pain thru to my arm, which was numb and tingly, and my hand felt like it was asleep...total pins and needles. shook it, didnt go away. mind you, I'm not a guy who thinks he's sick all the time, and is constantly at the doctor. I actually don't have a doctor, nor insurance, but I just usually ride whatever out..but this was becoming more than an annoyance. now its been three weeks or so, and the symptoms have just gotten worse. I'd say I've lost about 90% of the strength in my left hand. I can't make a fist, hold objects, pull up my pants, pick my nose, play my guitar, etc..my hand is never not buzzing with pins and needles, in a semi-claw shape, and its losing circulation as its noticeably purplish. yesterday, I called the urgent care that I use as a doctor if absolutely necessary, as I felt I had to do something. I asked if I could come down, described my symptoms, and they said all they'd do is tell me to go to the ER as it sounded not good..now numbness is going down my left leg and foot is swelling.
Age: 44.0
Sex: M
Vaccine: COVID19
Symptoms: Paraesthesia, Sleep disorder
Clinical narrative: had pain in left arm at injection site, but expected that. got sick after second dose (which is strange as I got really sick after the first one), that went away after roughly 36 hrs, however the injection site pain had radiated down the left arm. still, just assumed it'd go away, no worries. woke up the second day after shot, with feeling as if id maybe slept funny, as my shoulder on the left arm had a shooting pain thru to my arm, which was numb and tingly, and my hand felt like it was asleep...total pins and needles. shook it, didnt go away. mind you, I'm not a guy who thinks he's sick all the time, and is constantly at the doctor. I actually don't have a doctor, nor insurance, but I just usually ride whatever out..but this was becoming more than an annoyance. now its been three weeks or so, and the symptoms have just gotten worse. I'd say I've lost about 90% of the strength in my left hand. I can't make a fist, hold objects, pull up my pants, pick my nose, play my guitar, etc..my hand is never not buzzing with pins and needles, in a semi-claw shape, and its losing circulation as its noticeably purplish. yesterday, I called the urgent care that I use as a doctor if absolutely necessary, as I felt I had to do something. I asked if I could come down, described my symptoms, and they said all they'd do is tell me to go to the ER as it sounded not good..now numbness is going down my left leg and foot is swelling.
Age: 64.0
Sex: M
Vaccine: COVID19
Symptoms: Arthralgia, Mobility decreased, Pruritus
Clinical narrative: Less than 24 hours after 2nd shot extreme itching.  From then to now left elbow very hard to bend without extreme pain.  Have a hard time holding items now.
Age: 80.0
Sex: M
Vaccine: COVID19
Symptoms: Asthenia, Chills, Diarrhoea, Dyspnoea, Gait inability
Clinical narrative: Patient received second COVID 19 vaccine 5/15/21. Patient presented to the ED on 5/17/21 with cheif complaint of increased shortness of breath and weakness. On 5/16/21, he did not sleep well and felt sweaty with chills. He took ibuprofen and Tylenol.  He states he feels like he has no power when he walks.  No chest pain.  No fevers.  He also notes slight diarrhea.  Patient denies any Covid contacts.  There are no other modifying factors or associated symptoms
Age: 80.0
Sex: M
Vaccine: COVID19
Symptoms: Hyperhidrosis, Insomnia
Clinical narrative: Patient received second COVID 19 vaccine 5/15/21. Patient presented to the ED on 5/17/21 with cheif complaint of increased shortness of breath and weakness. On 5/16/21, he did not sleep well and felt sweaty with chills. He took ibuprofen and Tylenol.  He states he feels like he has no power when he walks.  No chest pain.  No fevers.  He also notes slight diarrhea.  Patient denies any Covid contacts.  There are no other modifying factors or associated symptoms
Age: 29.0
Sex: F
Vaccine: COVID19
Symptoms: Migraine, Nausea, Vomiting
Clinical narrative: Migraine lasting more than 24 hours, nausea/vomiting
Age: 33.0
Sex: M
Vaccine: COVID19
Symptoms: Contusion, Dizziness, Limb injury, Syncope, Tongue biting
Clinical narrative: "Pt received first Pfizer vaccine at 0920.  At 0922 he became lightheaded and fainted. He fell out of his chair onto the floor. RRT was called at 0922.He regained consciousness and was alert to person and place.   VS 02- 98% BP 86/36   House supervisor and Pharmacist arrived at 0923. Pt was conscious and talking. He did not report any injury to his head or neck. He states he hit his shoulder and may have bitten his tongue. Observed a small contusion on his tongue. No bleeding at this time.  He denies being diabetic. 0927-Vital signs  O2 97% BP- 104/64 Pt sat up and was given juice. He states he feels better and has fainted before with blood draws.  0931 Vital Signs-BP 97/82 02 96% 0945 Vital signs BP 96/77 02 98% Pt standing up and able to walk to hallway.    Given water and a granola bar.  0949- Pt called his wife.  1002 BP 108/73. He states he is feeling better, and standing.  1005-BP 123/80 1010 Pt escorted to elevator and to Cafeteria. Reports no pain.  He states he feels well and will eat something more and go home. "
Age: 14.0
Sex: F
Vaccine: COVID19
Symptoms: Dizziness, Hyperhidrosis
Clinical narrative: Lightheaded and sweaty 3 mins post vaccination Water was provided, patient rested Patient discharged to home
Age: 43.0
Sex: F
Vaccine: COVID19
Symptoms: Pain in extremity
Clinical narrative: BP 129/86, 71, 97, Nominal sinus.  Client c/o pain on left upper arm where the Pfizer vaccination was administered.  Writer gave client an ice pack and client had an Advil tab that she took orally.   Client then complained her right arm was hurting as well.  Code red was called and the paramedics arrived and took client's vitals.  Client's BP was 129/86, pulse 71, 20 breaths/min., pulse 97.  Client once hearing her vitals were normal stated she felt better and was ok to go home.
Sex: M
Vaccine: COVID19
Symptoms: Fatigue
Clinical narrative: EXTENDED FATIGUE; This spontaneous report received from a patient concerned a male of unspecified age. The patient's height, and weight were not reported. The patient's pre-existing medical conditions included the patient took shingles vaccine.The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: Unk) dose, start therapy date were not reported for prophylactic vaccination. The batch number was not reported. The Company is unable to perform follow-up to request batch/lot numbers. No concomitant medications were reported. On an unspecified date, the subject experienced extended fatigue. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient was recovering from extended fatigue. This report was non-serious.
Age: 38.0
Sex: F
Vaccine: COVID19
Symptoms: Fatigue, Malaise, Pain, Pain in extremity, Pyrexia
Clinical narrative: Fever (8 hrs), fatigue (24 hours), malaise (12 hours), sore arm (12 hours), body pain (24 hours)
Age: 32.0
Sex: M
Vaccine: COVID19
Symptoms: Dizziness, Hyperhidrosis, Malaise, Pallor, Vomiting
Clinical narrative: Approximately 7 mins after the patient received his first dose of the Moderna Covid-19 vaccine, he reported that he wasn't feeling well. A nurse and a medical technician addressed his concerns and the patient was diaphoretic, lightheaded, pale, and vomiting. We immediately provided 1 adult dose of epinephrine, laid him down with his feet elevated, and contacted EMS. Once he was stable to walk we moved him into a private room to be further assessed by EMS. Vitals were taken every 5 mins until the patient was transported to a local hospital.
Age: 59.0
Sex: F
Vaccine: COVID19
Symptoms: Arthritis, Blister, Chills, Injection site swelling, Pyrexia
Clinical narrative: Approximately 13 hours after vaccination I experienced a fever with chills combined with SEVERE spinal pain as well as right hip pain. and injection site swelling. The hip pain felt like a rod with a huge brushed head on it and felt like it was being continuously twisted into my hip. Vaccine was given on a Saturday.  This pain lasted into Tuesday morning followed by vomiting.  On Tuesday late afternoon my upper and lower lips broke out into numerous painfull blisters that would burst and bleed (I am not a regular to fever or mouth blisters).  It took approximately a week for them to settle down. The fever and chills subside Tuesday evening.  I tried Abreva as well as another professional brand without must success to subside the pain.  Today is day 20 since the outbreak and I still have a little larger than a pea size on the upper lip that is still healing.
Age: 59.0
Sex: F
Vaccine: COVID19
Symptoms: Spinal pain, Vomiting
Clinical narrative: Approximately 13 hours after vaccination I experienced a fever with chills combined with SEVERE spinal pain as well as right hip pain. and injection site swelling. The hip pain felt like a rod with a huge brushed head on it and felt like it was being continuously twisted into my hip. Vaccine was given on a Saturday.  This pain lasted into Tuesday morning followed by vomiting.  On Tuesday late afternoon my upper and lower lips broke out into numerous painfull blisters that would burst and bleed (I am not a regular to fever or mouth blisters).  It took approximately a week for them to settle down. The fever and chills subside Tuesday evening.  I tried Abreva as well as another professional brand without must success to subside the pain.  Today is day 20 since the outbreak and I still have a little larger than a pea size on the upper lip that is still healing.
Age: 52.0
Sex: M
Vaccine: COVID19
Symptoms: Dysphagia, Fatigue, Myasthenia gravis
Clinical narrative: History is indicative of recurrence of ocular myasthenia gravis. Uncertain whether he is having swallowing issue and fatigue as part of this. Symptoms began 2-3 weeks following his second Moderna Covid 19 vaccination.
Age: 53.0
Sex: F
Vaccine: COVID19
Symptoms: Diarrhoea, Fatigue, Headache, Myalgia, Nausea
Clinical narrative: Headache, nausea, high fever, muscle pain, nerve pain, diarrhea, vomiting, exhaustion
Age: 53.0
Sex: F
Vaccine: COVID19
Symptoms: Neuralgia, Pyrexia, Vomiting
Clinical narrative: Headache, nausea, high fever, muscle pain, nerve pain, diarrhea, vomiting, exhaustion
Age: 65.0
Sex: F
Vaccine: COVID19
Symptoms: Dizziness
Clinical narrative: Systemic: Dizziness/Lightheadedness-Medium.
Age: 24.0
Sex: F
Vaccine: COVID19
Symptoms: Chills, Dizziness, Fatigue, Headache, Pyrexia
Clinical narrative: High fever, chills, dizziness, headache, fatigue
Age: 49.0
Sex: F
Vaccine: COVID19
Symptoms: Pain in extremity, Ultrasound scan, X-ray
Clinical narrative: Sore arm; This spontaneous case was reported by a nurse and describes the occurrence of PAIN IN EXTREMITY (Sore arm) in a 50-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 037K20A and 013M20A) for COVID-19 vaccination.     No medical history was provided by the reporter.  Concomitant products included FLUOXETINE HYDROCHLORIDE (PROZAC) for Menopausal symptoms, PROPRANOLOL for Tremor.   On 29-Dec-2020, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 05-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 29-Dec-2020, the patient experienced PAIN IN EXTREMITY (Sore arm) (seriousness criterion medically significant). On 01-Jan-2021, PAIN IN EXTREMITY (Sore arm) had resolved.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 25-Apr-2021, Ultrasound scan: abnormal (abnormal) found a large benign mass (cyst) on left breast in the upper quadrant of the nipple approximately 5 cm. On 25-Apr-2021, X-ray: abnormal (abnormal) found a large benign mass (cyst) on left breast in the upper quadrant of the nipple approximately 5 cm.     For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   Treatment for the event included ibuprofen.  Company comment: Based on the current available information and temporal association between the use of the product and the start date of this event, a causal relationship cannot be excluded.   This case was linked to MOD-2021-127452 (Patient Link).; Sender's Comments: Based on the current available information and temporal association between the use of the product and the start date of this event, a causal relationship cannot be excluded.
Age: 43.0
Sex: F
Vaccine: COVID19
Symptoms: Abdominal pain, Dizziness, Flushing, Hyperhidrosis, Hypotension
Clinical narrative: Systemic: Abdominal Pain-Severe, Systemic: Dizziness / Lightheadness-Severe, Systemic: Fainting / Unresponsive-Severe, Systemic: Flushed / Sweating-Severe, Systemic: Hypotension-Medium, Systemic: Nausea-Medium
Age: 43.0
Sex: F
Vaccine: COVID19
Symptoms: Nausea, Syncope
Clinical narrative: Systemic: Abdominal Pain-Severe, Systemic: Dizziness / Lightheadness-Severe, Systemic: Fainting / Unresponsive-Severe, Systemic: Flushed / Sweating-Severe, Systemic: Hypotension-Medium, Systemic: Nausea-Medium
Age: 66.0
Sex: M
Vaccine: COVID19
Symptoms: Rash
Clinical narrative: Started as skin rash - went to doc - provided antivral for -- I had Shingrix shot in Summer 2018
Age: 49.0
Sex: F
Vaccine: COVID19
Symptoms: Breast cyst, Inappropriate schedule of product administration, Ultrasound scan, X-ray
Clinical narrative: large benign mass (cyst) on left breast 5cm; inappropriate schedule of vaccine administration; This spontaneous case was reported by a nurse and describes the occurrence of BREAST CYST (large benign mass (cyst) on left breast 5cm) in a 50-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 013M20A and 037K20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No medical history was reported.  Concomitant products included FLUOXETINE HYDROCHLORIDE (PROZAC) for Menopausal symptoms, PROPRANOLOL for Tremor.   On 29-Dec-2020, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 05-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 05-Feb-2021, the patient experienced INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (inappropriate schedule of vaccine administration). On 25-Apr-2021, the patient experienced BREAST CYST (large benign mass (cyst) on left breast 5cm) (seriousness criterion medically significant). On 05-Feb-2021, INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (inappropriate schedule of vaccine administration) had resolved. At the time of the report, BREAST CYST (large benign mass (cyst) on left breast 5cm) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 25-Apr-2021, Ultrasound scan: a large benign mass (cyst) on left breast in the u (abnormal) a large benign mass (cyst) on left breast in the upper quadrant of the nipple approximately 5 cm. On 25-Apr-2021, X-ray: a large benign mass (cyst) on left breast in the u (abnormal) a large benign mass (cyst) on left breast in the upper quadrant of the nipple approximately 5 cm.     For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   Treatment information was not provided.  Company comment: This report refers to a case of inappropriate schedule of vaccine administration for mRNA-1273, lot # 013M20A. 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.   This case was linked to MOD-2021-127410 (Patient Link).; Sender's Comments: This report refers to a case of inappropriate schedule of vaccine administration for mRNA-1273, lot # 013M20A. 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: 64.0
Sex: F
Vaccine: COVID19
Symptoms: Hypersensitivity, Myalgia, Vaccination site erythema, Vaccination site pruritus, Vaccination site swelling
Clinical narrative: started having allergic reaction; Swollen injection site; Itchy injection site; Red injection site; Pain in her whole body; This spontaneous case was reported by a consumer and describes the occurrence of HYPERSENSITIVITY (started having allergic reaction) in a 64-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 036A21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     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 MYALGIA (Pain in her whole body). On 02-Apr-2021, the patient experienced HYPERSENSITIVITY (started having allergic reaction) (seriousness criterion medically significant), VACCINATION SITE SWELLING (Swollen injection site), VACCINATION SITE PRURITUS (Itchy injection site) and VACCINATION SITE ERYTHEMA (Red injection site). In April 2021, HYPERSENSITIVITY (started having allergic reaction), VACCINATION SITE SWELLING (Swollen injection site), VACCINATION SITE PRURITUS (Itchy injection site), VACCINATION SITE ERYTHEMA (Red injection site) and MYALGIA (Pain in her whole body) had resolved.    The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No concomitant medications were reported.  A day after the first dose the patient had pain in whole body. Moreover, after ten days of getting the first dose, she started having allergic reaction, the injection site was red, swollen and itchy. These symptoms subsided after one week. Treatment information was not provided. Company comment: Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded.   This case was linked to MOD-2021-141740 (Patient Link).; Sender's Comments: Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded.
Age: 43.0
Sex: M
Vaccine: COVID19
Symptoms: Chills, Myalgia, Product dose omission issue, Pyrexia, Urticaria
Clinical narrative: did not get the 2nd dose (beyond day36 from 1st dose); slight fever; body chills; body aches; full body hives; This spontaneous case was reported by a patient and describes the occurrence of URTICARIA (full body hives) in a 43-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 017B21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.    On 25-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 27-Mar-2021, the patient experienced URTICARIA (full body hives) (seriousness criterion medically significant), PYREXIA (slight fever), CHILLS (body chills) and MYALGIA (body aches). On 28-Apr-2021, the patient experienced PRODUCT DOSE OMISSION ISSUE (did not get the 2nd dose (beyond day36 from 1st dose)). The patient was treated with EPINEPHRINE ongoing since an unknown date at an unspecified dose and frequency; DIPHENHYDRAMINE, PARACETAMOL, PHENYLPROPANOLAMINE HYDROCHLORIDE (BENADRYL [DIPHENHYDRAMINE;PARACETAMOL;PHENYLPROPANOLAMINE HYDROCHLORIDE]) ongoing since an unknown date at an unspecified dose and frequency and CETIRIZINE HYDROCHLORIDE (ZYRTEC ALLERGY) ongoing since an unknown date at an unspecified dose and frequency. On 27-Mar-2021, PYREXIA (slight fever), CHILLS (body chills) and MYALGIA (body aches) had resolved. On 01-Apr-2021, URTICARIA (full body hives) had resolved. On 28-Apr-2021, PRODUCT DOSE OMISSION ISSUE (did not get the 2nd dose (beyond day36 from 1st dose)) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       In ER patient was inserted intravenous line and given Epinephrine, Benadryl, Steroids, Zyrtec as a treatment. Patient was given Benadryl and Zyrtec as home medication to take for a week.  This report refers to a case of Product dose omission for mRNA-1273, and the AEs of Urticaria, Pyrexia, Chills, and Myalgia. Based on the current available information and temporal association between the use of the product and the start date of the AEs, a causal relationship cannot be excluded.; Sender's Comments: This report refers to a case of Product dose omission for mRNA-1273, and the AEs of Urticaria, Pyrexia, Chills, and Myalgia. Based on the current available information and temporal association between the use of the product and the start date of the AEs, a causal relationship cannot be excluded.
Age: 41.0
Sex: F
Vaccine: COVID19
Symptoms: Hypertension
Clinical narrative: blood pressure skyrocketed; This spontaneous case was reported by a consumer (subsequently medically confirmed) and describes the occurrence of HYPERTENSION (blood pressure skyrocketed) in a 41-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.   On an unknown date, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient experienced HYPERTENSION (blood pressure skyrocketed) (seriousness criterion hospitalization). At the time of the report, HYPERTENSION (blood pressure skyrocketed) had resolved. The patient was quadriplegic for the past fifteen years. She was fine after receiving the first vaccine. The patient received the second vaccine, then a few weeks after her blood pressure skyrocketed. She was hospitalized with her blood pressure spiking. As reported, she had been stable without issues for over one year. No treatment information was provided. 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  This case was linked  INC.-MOD-2021-142140 (E2B Linked Report).; 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 , INC.-MOD-2021-142140:crosslinked; brother in law
Age: 62.0
Sex: F
Vaccine: COVID19
Symptoms: Hepatic failure
Clinical narrative: Liver failure; This spontaneous case was reported by a nurse and describes the occurrence of HEPATIC FAILURE (Liver failure) in a 62-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On an unknown date, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced HEPATIC FAILURE (Liver failure) (seriousness criteria hospitalization and medically significant). The patient was hospitalized for 7 days due to HEPATIC FAILURE. At the time of the report, HEPATIC FAILURE (Liver failure) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   On an unknown date, a week post vaccination, the patient had liver failure and she ended up to stay in the hospital for a week.  No treatment information was provided.  Very limited information regarding this event has been provided at this time.  Further information has been requested. Based on the current available information and the temporal association between product use and the start date of the event a causal relationship cannot be excluded.   This case was linked to MODERNATX, INC.-MOD-2021-142944 (E2B Linked Report).; Sender's Comments: Very limited information regarding this event has been provided at this time.  Further information has been requested. Based on the current available information and the temporal association between product use and the start date of the event a causal relationship cannot be excluded. MODERNATX, INC.-MOD-2021-142944:
Age: 60.0
Sex: M
Vaccine: COVID19
Symptoms: Loss of consciousness
Clinical narrative: Passed out in traffic; This spontaneous case was reported by a consumer (subsequently medically confirmed) and describes the occurrence of LOSS OF CONSCIOUSNESS (Passed out in traffic) in a 61-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 025D21A) for COVID-19 vaccination.     No Medical History information was reported.   On 03-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 07-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 07-Apr-2021, the patient experienced LOSS OF CONSCIOUSNESS (Passed out in traffic) (seriousness criteria hospitalization and medically significant). The patient was hospitalized from 07-Apr-2021 to 09-Apr-2021 due to LOSS OF CONSCIOUSNESS. At the time of the report, LOSS OF CONSCIOUSNESS (Passed out in traffic) had resolved.            No relevant concomitant medications were provided.  No treatment medication was provided.  Patient also went to emergency room on 10 Apr 2021 and was examined for stroke and heart which came normal. No treatment information was provided. He wanted to know if Moderna can pay bills for the incurred loss.  Company comment: 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.   This case was linked to MOD-2021-142984 (E2B Linked Report).; 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. MOD-2021-142984:dose 1 case
Age: 16.0
Sex: M
Vaccine: COVID19
Symptoms: Feeling abnormal, Headache, Lethargy, Pyrexia
Clinical narrative: Headache 36 hours Fever 36 hours Brain fog continuing Lethargy ongoing  Ibuprofen was given for symptoms
Age: 43.0
Sex: F
Vaccine: COVID19
Symptoms: Anaphylactic reaction, Hot flush, Hypersensitivity, Oral lichen planus, Urticaria
Clinical narrative: Systemic Allergic Reaction 20 minutes after injection.  Felt it hit my spine, torso and head felt flush and hives started on torso.  Had I not taken the Allegra D that morning and Famotidine 1 hour before the shot, I would have gotten hives all over my torso and face and swelling would have started in my face.   I had an anaphylactic reaction but the histamine blocker and anti histamine kicked in after about 10-15minutes and I felt better.  Had I not taken the medicine I would have ended up in the Emergency Room.  That night I developed Oral Lichen Planus.  This became extremely bad and uncomfortable for the next 48 hours.  Then it started to heal.  It fully went away after 6-7 days.
Age: 57.0
Sex: F
Vaccine: COVID19
Symptoms: Chills, Gait disturbance, Inflammation, Migraine, Nausea
Clinical narrative: 1. extreme chills (but no fever) beginning at 3:30 pm, 2.  nausea beginning at 10 pm followed by one episode of  3. vomiting at 11:00 pm, nausea continued throughout the evening,  4. severe body aches beginning early the next morning -  5. severe pain in spine caused inability to walk or move without pain  for two days (pain upon moving was unbearable- to realize later I had some inflammation in my spine as a result of vaccine). 6. migraine  7. spinal pain and migraines have taken two months to return to pre-vaccine levels (I had NO spinal pain prior to vaccination)
Age: 57.0
Sex: F
Vaccine: COVID19
Symptoms: Pain, Spinal pain, Vomiting
Clinical narrative: 1. extreme chills (but no fever) beginning at 3:30 pm, 2.  nausea beginning at 10 pm followed by one episode of  3. vomiting at 11:00 pm, nausea continued throughout the evening,  4. severe body aches beginning early the next morning -  5. severe pain in spine caused inability to walk or move without pain  for two days (pain upon moving was unbearable- to realize later I had some inflammation in my spine as a result of vaccine). 6. migraine  7. spinal pain and migraines have taken two months to return to pre-vaccine levels (I had NO spinal pain prior to vaccination)
Age: 15.0
Sex: F
Vaccine: COVID19
Symptoms: Nausea, Vomiting
Clinical narrative: Systemic: Nausea-Mild, Systemic: Vomiting-Mild
Age: 47.0
Sex: F
Vaccine: COVID19
Symptoms: Expired product administered
Clinical narrative: Expired vaccine was administered to patient.
Age: 36.0
Sex: F
Vaccine: COVID19
Symptoms: Asthenia, Hypoaesthesia, Limb discomfort, Pain in extremity, Peripheral swelling
Clinical narrative: 5/22/21 around 3am- right leg pain, heaviness, mininal strength. I felt numbness, I could not lift leg by myself. Within 30 minutes it subsided- I could walk  5/23/21 to now.  I have been feeling sensation of numbness at the sole my feet. I can walk- it just doesn't feel right. 5/27/21- some swelling in both legs but subsided
Age: 58.0
Sex: F
Vaccine: COVID19
Symptoms: Arthralgia, Asthenia, Chills, Dizziness, Headache
Clinical narrative: nausea started at 1pm day of vaccine and lasted  72 hours,   DIARRHEA (severe) started at 2pm  day of vaccine and lasted  48 hours, VOMITING  (severe) started at 4pm day of vaccine and lasted 13 hours,   The following symptoms started at 3pm day of vaccine and continued for 72 hours aches and pain entire body,  muscle and joint pain, chills, dizziness, weakness, headache, pain at injection site.
Age: 58.0
Sex: F
Vaccine: COVID19
Symptoms: Injection site pain, Myalgia
Clinical narrative: nausea started at 1pm day of vaccine and lasted  72 hours,   DIARRHEA (severe) started at 2pm  day of vaccine and lasted  48 hours, VOMITING  (severe) started at 4pm day of vaccine and lasted 13 hours,   The following symptoms started at 3pm day of vaccine and continued for 72 hours aches and pain entire body,  muscle and joint pain, chills, dizziness, weakness, headache, pain at injection site.
Age: 39.0
Sex: M
Vaccine: COVID19
Symptoms: Dizziness, Headache, Pain, Sleep disorder
Clinical narrative: Systemic: Body Aches Generalized-Severe, Systemic: Dizziness / Lightheadness-Severe, Systemic: Headache-Severe, Systemic: Unable to Sleep-Severe
Age: 55.0
Sex: F
Vaccine: COVID19
Symptoms: Headache, Hypoaesthesia
Clinical narrative: Numbness in her arm and hand,Headache
Age: 64.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Dyspnoea
Clinical narrative: HPI   Here for breathing complaints   1. SOA on exertion: States since she had the covid vaccine in April her breathing has gotten worse, mainly when she is is exercising but occasionally when she is resting she feels like she has to breathe faster She uses albuterol inhaler a few times a day but it doesn't seem like it is helping She used to take a daily inhaler but doesn't recall which one She was treated for RUL infiltrate in March of this year Pt had covid infection in October 2020
Age: 32.0
Sex: M
Vaccine: COVID19
Symptoms: Incorrect dose administered
Clinical narrative: Error: Wrong Dose of Vaccine - Too High.
Age: 27.0
Sex: M
Vaccine: COVID19
Symptoms: Dizziness, Flushing, Hyperhidrosis, Nausea, Vomiting
Clinical narrative: Systemic: Dizziness / Lightheadness-Severe, Systemic: Flushed / Sweating-Medium, Systemic: Nausea-Severe, Systemic: Vomiting-Medium
Age: 23.0
Sex: F
Vaccine: COVID19
Symptoms: Chills, Dizziness, Headache, Pain, Pyrexia
Clinical narrative: Fever, chills, dizzy, headache, body soreness.
Age: 46.0
Sex: M
Vaccine: COVID19
Symptoms: Headache, Pain, Pyrexia
Clinical narrative: Fever of 101.  Body and head aches.  Lasted for about 24 hours.  Woke up on the 28th feeling fine. Tylenol seemed to work better for pain as opposed to Advil and Aleve.
Age: 36.0
Sex: F
Vaccine: COVID19
Symptoms: Chills, Fatigue, Pain, Pyrexia
Clinical narrative: 102 degree F fever, aches, chills, fatigue
Age: 43.0
Sex: M
Vaccine: COVID19
Symptoms: Muscle twitching
Clinical narrative: I have had muscle twitches on various portions of my upper right side (hand, arm, pec, abdomen) for the past three months daily.
Age: 14.0
Sex: M
Vaccine: COVID19
Symptoms: Eye pruritus, Lymphadenopathy, Rash
Clinical narrative: Large rash under both armpits and swelling and itching of eyes.
Age: 67.0
Sex: F
Vaccine: COVID19
Symptoms: Abdominal pain upper, Appendicectomy, Appendicitis perforated
Clinical narrative: severe stomach pain. Resulting in ruptured appendices.
Age: 19.0
Sex: F
Vaccine: COVID19
Symptoms: Dizziness, Headache, Hypotension, Nausea, Syncope
Clinical narrative: Systemic: Dizziness / Lightheadness-Mild, Systemic: Fainting / Unresponsive-Mild, Systemic: Headache-Mild, Systemic: Hypotension-Mild, Systemic: Nausea-Mild
Age: 19.0
Sex: F
Vaccine: COVID19
Symptoms: Unresponsive to stimuli
Clinical narrative: Systemic: Dizziness / Lightheadness-Mild, Systemic: Fainting / Unresponsive-Mild, Systemic: Headache-Mild, Systemic: Hypotension-Mild, Systemic: Nausea-Mild
Age: 42.0
Sex: M
Vaccine: COVID19
Symptoms: Herpes zoster, Pain, Rash, Sensitive skin
Clinical narrative: Shingles - painful, sensitive skin, followed by severe rash on and around the left hip.
Age: 31.0
Sex: F
Vaccine: COVID19
Symptoms: Anxiety, Flushing, Hypoaesthesia, Paraesthesia
Clinical narrative: Patient experienced apprehension, flusing and numbness and tingling, patient moved to the floor in a supine position and was monitored by staff at medical center.  Patient left on her own after observation.
Age: 34.0
Sex: M
Vaccine: COVID19
Symptoms: Chills, Pyrexia
Clinical narrative: Chills and fever
Age: 50.0
Sex: F
Vaccine: COVID19
Symptoms: Erythema, Pruritus, Urticaria
Clinical narrative: Red Itchy whelpy reaction spots all over about 50% of body. Started yesterday morning. Took 2 doses of benedryl so far.
Age: 50.0
Sex: F
Vaccine: COVID19, COVID19, COVID19
Symptoms: Injected limb mobility decreased, Injection site pain, Injection site paraesthesia, Shoulder injury related to vaccine administration
Clinical narrative: Site: Pain at Injection Site-Severe, Error: Shoulder Joint Injury (prolonged pain, tingling, etc.), Additional Details: Patient states she has not been able to move her arm since vaccine was given- she says she has seen a doctor and will need to go to physcial therapy with a copay of 60 dollars everytime she goes
Age: 50.0
Sex: F
Vaccine: COVID19, COVID19, COVID19
Symptoms: Injection site pain
Clinical narrative: Site: Pain at Injection Site-Severe, Error: Shoulder Joint Injury (prolonged pain, tingling, etc.), Additional Details: Patient states she has not been able to move her arm since vaccine was given- she says she has seen a doctor and will need to go to physcial therapy with a copay of 60 dollars everytime she goes
Age: 50.0
Sex: F
Vaccine: COVID19, COVID19, COVID19
Symptoms: Arthralgia, Arthropathy, Paraesthesia
Clinical narrative: Site: Pain at Injection Site-Severe, Error: Shoulder Joint Injury (prolonged pain, tingling, etc.), Additional Details: Patient states she has not been able to move her arm since vaccine was given- she says she has seen a doctor and will need to go to physcial therapy with a copay of 60 dollars everytime she goes
Age: 75.0
Sex: F
Vaccine: COVID19
Symptoms: Fatigue, Feeling abnormal, Heart rate decreased, Lethargy, Palpitations
Clinical narrative: My mom never told me she got both vaccines. We all came for a funeral 2 weeks after she got her second dose. She is normally active and energetic but  she was very lethargic and tired. Her heart was racing and her pulse was low. She literally  started contemplating death and planning her funeral. She said this was the worse she had felt in years! Possibly ever! She didn't though thank God.  It took her a couple months and heavy supplements to get back close to normal.
Age: 16.0
Sex: M
Vaccine: COVID19
Symptoms: C-reactive protein normal, Chest pain, Coxsackie virus test, Full blood count normal, Lipids normal
Clinical narrative: Chest pain, elevated troponin. No treatment, no cardiac dysfunction.
Age: 16.0
Sex: M
Vaccine: COVID19
Symptoms: Liver function test normal, Parvovirus B19 test, Polymerase chain reaction, Polymerase chain reaction positive, Red blood cell sedimentation rate normal
Clinical narrative: Chest pain, elevated troponin. No treatment, no cardiac dysfunction.
Age: 16.0
Sex: M
Vaccine: COVID19
Symptoms: Respiratory viral panel, Serum ferritin normal, Troponin increased
Clinical narrative: Chest pain, elevated troponin. No treatment, no cardiac dysfunction.
Age: 53.0
Sex: F
Vaccine: COVID19
Symptoms: Loss of consciousness, Syncope, Unresponsive to stimuli
Clinical narrative: Systemic: Fainting / Unresponsive-Medium, Additional Details: Patient lost consiousness within one minute of receiving covid-19 vaccine. Regained consciousness within a few seconds. Checked vitals which were stable and had patient lie on floor with feet up. Monitored patient for at least 30 minutes and rechecked vitals which were stable. Patient reported no further issues upon follow-up a few hours later
Age: 78.0
Sex: M
Vaccine: COVID19
Symptoms: Rash
Clinical narrative: Systemic: Allergic: Rash Generalized-Medium, Additional Details: Patient called on 05/27/2021 after receiving covid-19 vaccine on 05/19/2021 to report a rash on lower back and inner thigh. Patient says it is not itchy. Patient noticed it appeared around Monday 05/24/2021.
Age: 48.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Headache, Intracranial aneurysm, Laboratory test, Unresponsive to stimuli, Vomiting
Clinical narrative: At approximately 9:45pm, c/o a headache while providing patient care, she then had an emesis that was greenish in color and went unresponsive.  Emergency services was contacted,   arrived approximately 5 minutes later to transport her to the local  ER via stretcher.    Facility received an update from patient's daughter later that night,  informing staff that she had experienced a brain aneurysm and was being transferred to Hospital.
Age: 48.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Brain operation, Computerised tomogram head abnormal, Intensive care, Intracranial aneurysm
Clinical narrative: At approximately 9:45pm, c/o a headache while providing patient care, she then had an emesis that was greenish in color and went unresponsive.  Emergency services was contacted,   arrived approximately 5 minutes later to transport her to the local  ER via stretcher.    Facility received an update from patient's daughter later that night,  informing staff that she had experienced a brain aneurysm and was being transferred to Hospital.
Age: 27.0
Sex: M
Vaccine: COVID19
Symptoms: Anaphylactic reaction, Asthenia, Chest discomfort, Dizziness, Palpitations
Clinical narrative: Diffuse urticarial rash involving right axilla and over bilateral  shoulders, developed intense chest pressure and squeezing, heart racing  and when those symptoms resolved pt. became very weak. Of note pt. stated was lightheaded for 15 mins after receiving the vaccine
Age: 27.0
Sex: M
Vaccine: COVID19
Symptoms: Rash, Urticaria
Clinical narrative: Diffuse urticarial rash involving right axilla and over bilateral  shoulders, developed intense chest pressure and squeezing, heart racing  and when those symptoms resolved pt. became very weak. Of note pt. stated was lightheaded for 15 mins after receiving the vaccine
Age: 60.0
Sex: F
Vaccine: COVID19
Symptoms: Arthralgia, Chest discomfort, Injection site pain, Neck pain, Pain
Clinical narrative: Site: Pain at Injection Site-Medium, Systemic: Chest Tightness / Heaviness / Pain-Medium, Systemic: Tinnitus-Medium, Additional Details: The patient reported left shoulder pain that radiated up her neck, with tinnitus in the left ear and chest tightness that has not resolved since getting the vaccine
Age: 60.0
Sex: F
Vaccine: COVID19
Symptoms: Tinnitus
Clinical narrative: Site: Pain at Injection Site-Medium, Systemic: Chest Tightness / Heaviness / Pain-Medium, Systemic: Tinnitus-Medium, Additional Details: The patient reported left shoulder pain that radiated up her neck, with tinnitus in the left ear and chest tightness that has not resolved since getting the vaccine
Age: 77.0
Sex: F
Vaccine: VARZOS
Symptoms: Arthralgia, Asthenia, Erythema, Fatigue, Injection site pain
Clinical narrative: Pain at injection site. Very large area of redness. Weak and tired on awakening next day. More than usual joint pain. Terrible pain in right buttock ( related?). Slept all day. Normally very active for my age.
Age: 77.0
Sex: F
Vaccine: VARZOS
Symptoms: Musculoskeletal pain
Clinical narrative: Pain at injection site. Very large area of redness. Weak and tired on awakening next day. More than usual joint pain. Terrible pain in right buttock ( related?). Slept all day. Normally very active for my age.
Age: 21.0
Sex: F
Vaccine: COVID19
Symptoms: Expired product administered
Clinical narrative: patient was administered an expired vaccine
Age: 39.0
Sex: M
Vaccine: COVID19
Symptoms: Chills, Fatigue, Influenza like illness, Pyrexia, Vaccine positive rechallenge
Clinical narrative: Fever 100.5. Chills, fatigue, vomiting. Very much flu-like. Lasted about 24 hrs. Took Motrin then Tylenol. Rested and hydrated. I had the same reaction with the first shot, but this time,  the symptoms came on faster and ended faster.
Age: 39.0
Sex: M
Vaccine: COVID19
Symptoms: Vomiting
Clinical narrative: Fever 100.5. Chills, fatigue, vomiting. Very much flu-like. Lasted about 24 hrs. Took Motrin then Tylenol. Rested and hydrated. I had the same reaction with the first shot, but this time,  the symptoms came on faster and ended faster.
Age: 35.0
Sex: F
Vaccine: COVID19
Symptoms: Incorrect dose administered
Clinical narrative: patient was given 0.5 mL instead of 0.3 mL
Age: 32.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Acoustic stimulation tests normal, Tinnitus
Clinical narrative: Ringing in left ear.
Age: 20.0
Sex: F
Vaccine: COVID19
Symptoms: Chest X-ray, Chest pain, Electrocardiogram, Epistaxis, Peripheral swelling
Clinical narrative: Hives on arms, left side of face, severe swelling in left leg , nose bleeds, and chest pain.
Age: 20.0
Sex: F
Vaccine: COVID19
Symptoms: Troponin, Urticaria
Clinical narrative: Hives on arms, left side of face, severe swelling in left leg , nose bleeds, and chest pain.
Age: 26.0
Sex: F
Vaccine: COVID19
Symptoms: Nausea, Seizure, Vomiting
Clinical narrative: Systemic: Nausea-Mild, Systemic: Seizure-Mild, Systemic: Vomiting-Mild, Additional Details: After Janssen vaccine shot given to patient.Patient lowered her face and body to our blood machine monitor and appear to experienced partial seizure with mild symptoms. Called 911. Patient was assessed her side effects and she told them that she had history of epilepsy and haven't had an episode for at least a year. Provide water to her and also garbage bin next to her due to Patient being nausea. Paramedics arrived about 3 minutes after they were called.
Age: 29.0
Sex: F
Vaccine: COVID19
Symptoms: Fatigue, Hyperhidrosis, Pyrexia, Urticaria
Clinical narrative: fever and fatigue and sweats x 9 days with development of urticaria at day 9
Age: 46.0
Sex: F
Vaccine: COVID19
Symptoms: Eye irritation, Eye swelling, Rash, Swelling face
Clinical narrative: Burning eyes. Left eye worse than the right. Left face and eye swelling. Rash on face, neck. Random spots of rash on body
Age: 58.0
Sex: F
Vaccine: COVID19
Symptoms: Injection site pruritus
Clinical narrative: Site: Itching at Injection Site-Mild, Systemic: Patient came in on 5/20/2021 reporting that she got a bad shot on 04/22/2021. Pharmacist on duty asked patient what reaction did the patient get. Patient refused to answer and left the pharmacy. Pharmacist tried to follow up with the patient but phone num-Mild, Additional Details: Patient came in on 5/20/2021 reporting that she got a bad shot on 04/22/2021. Pharmacist on duty asked patient what reaction did the patient get. Patient refused to answer and left the pharmacy. Pharmacist tried to follow up with the patient but phone number is invalid.
Age: 56.0
Sex: F
Vaccine: VARZOS
Symptoms: Axillary pain, Injection site pain, Lymphadenopathy
Clinical narrative: site pain, and swelling in the lympnodes/armpit of right arm
Age: 67.0
Sex: F
Vaccine: COVID19
Symptoms: Incorrect dose administered
Clinical narrative: patient was given 0.5 mL instead of 0.3 mL
Age: 57.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Herpes zoster
Clinical narrative: I was diagnosed by Dr. on 5/27/2021 as having shingles.  He did not communicate any connection to the virus.  After researching online, I saw where there was some evidence of a connection, and to report it here.  I was prescribed ValACYclovir which I began taking on 5/27/2021.
Age: 68.0
Sex: F
Vaccine: COVID19
Symptoms: Expired product administered
Clinical narrative: patient administered an expired vaccine
Age: 20.0
Sex: M
Vaccine: COVID19
Symptoms: Confusional state, Dizziness, Seizure, Vomiting
Clinical narrative: Systemic: Confusion-Mild, Systemic: Dizziness / Lightheadness-Mild, Systemic: Seizure-Medium, Systemic: Vomiting-Severe
Age: 78.0
Sex: F
Vaccine: COVID19
Symptoms: Incorrect dose administered
Clinical narrative: patient was given 0.5 mL instead of 0.3 mL
Age: 54.0
Sex: M
Vaccine: COVID19
Symptoms: Aphonia, Arthralgia, Blood test, Chills, Computerised tomogram head
Clinical narrative: First 10 days: High fever, chills, high blood pressure, headache, inability to swallow, entire left side numb (face, head, shoulder, arm), loss of voice Next 28 days and current: loss of voice, swallowing hard, shoulder pain, limited shoulder movement, tight neck in the left side
Age: 54.0
Sex: M
Vaccine: COVID19
Symptoms: Computerised tomogram neck, Dysphagia, Headache, Hypertension, Hypoaesthesia
Clinical narrative: First 10 days: High fever, chills, high blood pressure, headache, inability to swallow, entire left side numb (face, head, shoulder, arm), loss of voice Next 28 days and current: loss of voice, swallowing hard, shoulder pain, limited shoulder movement, tight neck in the left side
Age: 54.0
Sex: M
Vaccine: COVID19
Symptoms: Joint range of motion decreased, Magnetic resonance imaging head abnormal, Muscle tightness, Pyrexia, Transient ischaemic attack
Clinical narrative: First 10 days: High fever, chills, high blood pressure, headache, inability to swallow, entire left side numb (face, head, shoulder, arm), loss of voice Next 28 days and current: loss of voice, swallowing hard, shoulder pain, limited shoulder movement, tight neck in the left side
Age: 31.0
Sex: M
Vaccine: COVID19
Symptoms: Dizziness, Hypotension, Loss of consciousness, Syncope
Clinical narrative: Systemic: Dizziness / Lightheadness-Severe, Systemic: Fainting / Unresponsive-Severe, Systemic: Hypotension-Severe