chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 51.0
Sex: F
Vaccine: COVID19
Symptoms: Dizziness, Headache, Injection site pain, Syncope, Vision blurred
Clinical narrative: FAINTING; DIZZINESS; BLURRED VISION; PAIN AT THE INJECTION SITE; HEADACHE; This spontaneous report received from a patient concerned a 51-year old White Hispanic or Latino female. The patient's weight, height, and medical history were not reported.The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 1808986 expiries: UNKNOWN) frequency one total, dose was not reported, administered on left arm on 16-MAY-2021 for prophylactic vaccination. No concomitant medications were reported.  After the vaccination Symptoms started on 18-MAY-2021 dizziness, pain at the injection site, and blurred vision.it was also reported she fainted while walking back home. All the symptoms resolved.The Patient was complaining of a headache at the moment of reporting. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from fainting, dizziness, blurred vision, and pain at the injection site on 18-MAY-2021, and had not recovered from headache. This report was serious (Other Medically Important Condition).; Sender's Comments: V0: 20210534713-COVID-19 VACCINE AD26.COV2.S-Fainting. This event(s) is considered unassessable. The event(s) has a compatible/suggestive temporal relationship, is unlabeled, and has unknown scientific plausibility. There is no information on any other factors potentially associated with the event(s).
Sex: F
Vaccine: COVID19
Symptoms: Asthenia, Diarrhoea, Dizziness, Fatigue, Myalgia
Clinical narrative: DIARRHEA; FELT A LITTLE NAUSEOUS; EXTREME WEAKNESS; DIZZINESS(COULD NOT WALK); WIPED OUT; MUSCLE PAIN; This spontaneous report received from a patient concerned a 64 year old female. The patient's weight was 120 pounds, and height was 70 inches. The patient's concurrent conditions included menopause. The patient was previously treated with vitamins nos. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 203A21A, expiry: UNKNOWN) dose was not reported, administered on 13-MAY-2021 16:55 for prophylactic vaccination. Concomitant medications included . On 14-MAY-2021, the subject experienced muscle pain. On 16-MAY-2021, the subject experienced dizziness (could not walk). On 16-MAY-2021, the subject experienced extreme weakness. On 16-MAY-2021, the subject experienced wiped out. On 17-MAY-2021, the subject experienced diarrhea. On 17-MAY-2021, the subject experienced felt a little nauseous. Treatment medications (dates unspecified) included: bismuth subsalicylate. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from felt a little nauseous on 17-MAY-2021, and muscle pain, was recovering from diarrhea, had not recovered from extreme weakness, and the outcome of dizziness(could not walk) and wiped out was not reported. This report was non-serious.
Sex: F
Vaccine: COVID19
Symptoms: Nausea
Clinical narrative: DIARRHEA; FELT A LITTLE NAUSEOUS; EXTREME WEAKNESS; DIZZINESS(COULD NOT WALK); WIPED OUT; MUSCLE PAIN; This spontaneous report received from a patient concerned a 64 year old female. The patient's weight was 120 pounds, and height was 70 inches. The patient's concurrent conditions included menopause. The patient was previously treated with vitamins nos. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 203A21A, expiry: UNKNOWN) dose was not reported, administered on 13-MAY-2021 16:55 for prophylactic vaccination. Concomitant medications included . On 14-MAY-2021, the subject experienced muscle pain. On 16-MAY-2021, the subject experienced dizziness (could not walk). On 16-MAY-2021, the subject experienced extreme weakness. On 16-MAY-2021, the subject experienced wiped out. On 17-MAY-2021, the subject experienced diarrhea. On 17-MAY-2021, the subject experienced felt a little nauseous. Treatment medications (dates unspecified) included: bismuth subsalicylate. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from felt a little nauseous on 17-MAY-2021, and muscle pain, was recovering from diarrhea, had not recovered from extreme weakness, and the outcome of dizziness(could not walk) and wiped out was not reported. This report was non-serious.
Sex: M
Vaccine: COVID19
Symptoms: Fatigue, Pain in extremity
Clinical narrative: SORE ARM; FATIGUE; This spontaneous report received from a patient concerned a male of unspecified age. The patient's weight, height, and medical history were not reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 1808980 expiry: UNKNOWN) dose was not reported, administered on 31-MAR-2021 for prophylactic vaccination. No concomitant medications were reported. On 2021, the subject experienced sore arm. On 2021, the subject experienced fatigue. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the fatigue and sore arm was not reported. This report was non-serious.
Age: 45.0
Sex: F
Vaccine: COVID19
Symptoms: Back pain, Condition aggravated, Hypoaesthesia, Illness, Pain
Clinical narrative: Starting the day after my 2nd shot, I started to experience lower back pain.  Over the following week, the pain intensified until it was so excruciating that I was completely debilitated. I was prescribed a steroid anti inflammatory and muscle relaxants. The next day the pain included radiating leg pain and numbness down my calf and including several toes. The pain was unbearable and the doctor recommended I go to the emergency room, which I did. At the ER I was given 2 injections. One, a powerful pain killer, (dilaudid), and the other, an anti-inflammatory, (toradol). After the powerful pain killer from the ER, the back pain mostly subsided, but the radiating leg pain and numbness persisted very intensely for the first few weeks, and less now, but it's still not gone.  I had a previous experience about 15 years ago of excruciating back pain due to a herniated disc, but my back has been doing well for the last 10 years or so and there was nothing I?m aware of that might have set it off. While I can?t say for sure if it was caused by the 2nd vaccine shot, because of the time correlation and after reading that extreme back pain can be a symptom of covid, I thought it was worth reporting.
Age: 45.0
Sex: F
Vaccine: COVID19
Symptoms: Pain in extremity
Clinical narrative: Starting the day after my 2nd shot, I started to experience lower back pain.  Over the following week, the pain intensified until it was so excruciating that I was completely debilitated. I was prescribed a steroid anti inflammatory and muscle relaxants. The next day the pain included radiating leg pain and numbness down my calf and including several toes. The pain was unbearable and the doctor recommended I go to the emergency room, which I did. At the ER I was given 2 injections. One, a powerful pain killer, (dilaudid), and the other, an anti-inflammatory, (toradol). After the powerful pain killer from the ER, the back pain mostly subsided, but the radiating leg pain and numbness persisted very intensely for the first few weeks, and less now, but it's still not gone.  I had a previous experience about 15 years ago of excruciating back pain due to a herniated disc, but my back has been doing well for the last 10 years or so and there was nothing I?m aware of that might have set it off. While I can?t say for sure if it was caused by the 2nd vaccine shot, because of the time correlation and after reading that extreme back pain can be a symptom of covid, I thought it was worth reporting.
Age: 51.0
Sex: F
Vaccine: COVID19
Symptoms: Blood glucose normal, Dizziness, Electrocardiogram normal, Feeling hot, Headache
Clinical narrative: STARTING SEVERAL MINUTES AFTER VACCINE-FEELING HOT, HEADACHE, DIZZINESS, NAUSEA
Age: 51.0
Sex: F
Vaccine: COVID19
Symptoms: Nausea
Clinical narrative: STARTING SEVERAL MINUTES AFTER VACCINE-FEELING HOT, HEADACHE, DIZZINESS, NAUSEA
Age: 36.0
Sex: F
Vaccine: COVID19
Symptoms: Loss of consciousness, Syncope
Clinical narrative: Patient had a syncope event minutes after receiving first moderna covid vaccine. She was in and out of consciousness more that once for a period of 10 -15 minutes. She fully regained consciousness at the end of that period and stayed that way until she was comfortable enough to leave the premise.
Age: 30.0
Sex: M
Vaccine: COVID19
Symptoms: Epilepsy, Vision blurred
Clinical narrative: Eye blurry ness, epileptic seizures
Age: 61.0
Sex: M
Vaccine: COVID19
Symptoms: Tinnitus
Clinical narrative: Tinnitus both ears pronounced in left ear
Sex: M
Vaccine: COVID19
Symptoms: Hospitalisation, Incomplete course of vaccination
Clinical narrative: Was in and out of the hospital; His second shot is now more than 42 days after the first shot; This spontaneous case was reported by a consumer (subsequently medically confirmed) and describes the occurrence of HOSPITALISATION (Was in and out of the hospital) in a male patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported. On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced HOSPITALISATION (Was in and out of the hospital) (seriousness criterion hospitalization) and INCOMPLETE COURSE OF VACCINATION (His second shot is now more than 42 days after the first shot). At the time of the report, HOSPITALISATION (Was in and out of the hospital) outcome was unknown and INCOMPLETE COURSE OF VACCINATION (His second shot is now more than 42 days after the first shot) had resolved.  The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown. No concomitant medications provided. The patient was in the hospital and his second shot was now more than 42 days after the first shot. He was in and out of the hospital and this put his schedule off caller. No treatment information provided.  Company Comment:  Very limited information regarding this event of hospitalization has been provided at this time. Further information has been requested. Based on the current information available, temporal association between the use of the product and the start date of the event of hospitalization, a causal relationship cannot be excluded.; Sender's Comments: Very limited information regarding this event of hospitalization has been provided at this time. Further information has been requested. Based on the current information available, temporal association between the use of the product and the start date of the event of hospitalization, a causal relationship cannot be excluded.
Age: 53.0
Sex: F
Vaccine: COVID19
Symptoms: Dizziness, Fatigue, Flushing, Hyperhidrosis, Hypotension
Clinical narrative: Systemic: Dizziness / Lightheadness-Severe, Systemic: Exhaustion / Lethargy-Severe, Systemic: Flushed / Sweating-Medium, Systemic: Hypotension-Medium, Systemic: Nausea-Severe
Age: 53.0
Sex: F
Vaccine: COVID19
Symptoms: Lethargy, Nausea
Clinical narrative: Systemic: Dizziness / Lightheadness-Severe, Systemic: Exhaustion / Lethargy-Severe, Systemic: Flushed / Sweating-Medium, Systemic: Hypotension-Medium, Systemic: Nausea-Severe
Age: 22.0
Sex: F
Vaccine: COVID19
Symptoms: Discomfort, Feeling abnormal, Flushing, Hyperhidrosis, Injection site erythema
Clinical narrative: Site: Redness at Injection Site-Mild, Systemic: Allergic: Rash Generalized-Mild, Systemic: Flushed / Sweating-Mild, Additional Details: Patient stated they "felt weird, like really heavy" immediately after receiving shot. Patient was observed to have hives/redness on the entire upper arm and shoulder where the vaccine was administered and was flushed. Patient stated that there was no itching or difficulty breathing. Patient stayed on site after receiving the shot to be observed. The hives/redness faded after approximately 10 minutes and at 30 minutes after receiving the shot the patient went home with no further incident.
Age: 22.0
Sex: F
Vaccine: COVID19
Symptoms: Injection site rash, Injection site urticaria
Clinical narrative: Site: Redness at Injection Site-Mild, Systemic: Allergic: Rash Generalized-Mild, Systemic: Flushed / Sweating-Mild, Additional Details: Patient stated they "felt weird, like really heavy" immediately after receiving shot. Patient was observed to have hives/redness on the entire upper arm and shoulder where the vaccine was administered and was flushed. Patient stated that there was no itching or difficulty breathing. Patient stayed on site after receiving the shot to be observed. The hives/redness faded after approximately 10 minutes and at 30 minutes after receiving the shot the patient went home with no further incident.
Age: 31.0
Sex: M
Vaccine: COVID19
Symptoms: Product administered at inappropriate site
Clinical narrative: Error: Improper Storage (temperature)
Age: 24.0
Sex: M
Vaccine: COVID19
Symptoms: Dizziness, Dysstasia, Fall
Clinical narrative: Severe dizziness. Causing me to fall and not be able to stand.
Age: 72.0
Sex: F
Vaccine: COVID19
Symptoms: Injection site bruising, Injection site erythema, Injection site reaction
Clinical narrative: Site: Bruising at Injection Site-Mild, Site: Redness at Injection Site-Mild, Additional Details: pt came to pharmacy on 5/19/2021 to show/discuss brusing and slight redness near injection site area. Patient has also experienced bruising/itching/injection site reaction (lump) to flu shot approximately 2 years ago.
Age: 14.0
Sex: M
Vaccine: COVID19
Symptoms: Incorrect dose administered
Clinical narrative: PATIENT GIVEN 0.5 ML DOSE INSTEAD OF 0.3ML
Age: 64.0
Sex: F
Vaccine: COVID19
Symptoms: Arrhythmia, Heart rate, Heart rate increased
Clinical narrative: After 2 weeks later she diagnosed with heart arrhythmia; Patient heart rate was 205 and doctor does not want it go over 100; This spontaneous case was reported by a consumer (subsequently medically confirmed) and describes the occurrence of ARRHYTHMIA (After 2 weeks later she diagnosed with heart arrhythmia) in a 64-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 048B21A and 006B21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below. No Medical History information was reported. Concomitant products included VITAMIN D [VITAMIN D NOS] for an unknown indication.   On 27-Apr-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced ARRHYTHMIA (After 2 weeks later she diagnosed with heart arrhythmia) (seriousness criteria hospitalization and medically significant) and HEART RATE INCREASED (Patient heart rate was 205 and doctor does not want it go over 100). At the time of the report, ARRHYTHMIA (After 2 weeks later she diagnosed with heart arrhythmia) and HEART RATE INCREASED (Patient heart rate was 205 and doctor does not want it go over 100) outcome was unknown. Serious event as per Important medical event terms list (version 24.0)    DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, Heart rate: 205 (High) Patient heart rate was 205 and doctor does not want it go over 100..  Treatment for the heart arrhythmia included alprazolam. The patient received both scheduled doses of mRNA-1273 prior to the events therefore, action taken with the drug in response to the event is not applicable.  Company comment Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded.; 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: Amnesia, Loss of consciousness, Respiratory rate increased
Clinical narrative: loss of consciousness; started breathing really hard; does not remember anything; This spontaneous case was reported by a pharmacist and describes the occurrence of LOSS OF CONSCIOUSNESS (loss of consciousness) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.    On an unknown date, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced LOSS OF CONSCIOUSNESS (loss of consciousness) (seriousness criterion medically significant), RESPIRATORY RATE INCREASED (started breathing really hard) and AMNESIA (does not remember anything). At the time of the report, LOSS OF CONSCIOUSNESS (loss of consciousness), RESPIRATORY RATE INCREASED (started breathing really hard) and AMNESIA (does not remember anything) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   No concomitant medications reported. No treatment details provided for these events.
Age: 44.0
Sex: F
Vaccine: COVID19
Symptoms: Ageusia, Anosmia, Blood potassium, COVID-19 pneumonia, Feeding disorder
Clinical narrative: HCP diagnosed low Potassium and "Covid Pneumonia"; did not feel well; Patient lost senses of taste and smell and could not eat. Also had headache, body aches and did not feel well; body aches; could not eat; Patient lost senses of taste; Patient lost senses smell; This spontaneous case was reported by a consumer (subsequently medically confirmed) and describes the occurrence of COVID-19 PNEUMONIA (HCP diagnosed low Potassium and "Covid Pneumonia") in a 44-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 036B21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     The patient's past medical history included COVID-19 virus test negative on 14-Apr-2021.    On 10-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 11-Apr-2021, the patient experienced FEEDING DISORDER (could not eat), AGEUSIA (Patient lost senses of taste) and ANOSMIA (Patient lost senses smell). On 12-Apr-2021, the patient experienced MALAISE (did not feel well), HEADACHE (Patient lost senses of taste and smell and could not eat. Also had headache, body aches and did not feel well) and MYALGIA (body aches). On 14-Apr-2021, the patient experienced COVID-19 PNEUMONIA (HCP diagnosed low Potassium and "Covid Pneumonia") (seriousness criterion medically significant). At the time of the report, COVID-19 PNEUMONIA (HCP diagnosed low Potassium and "Covid Pneumonia"), MALAISE (did not feel well), FEEDING DISORDER (could not eat), AGEUSIA (Patient lost senses of taste), ANOSMIA (Patient lost senses smell), HEADACHE (Patient lost senses of taste and smell and could not eat. Also had headache, body aches and did not feel well) and MYALGIA (body aches) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 14-Apr-2021, Blood potassium: low (Low) Low.     The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       Patient took Tylenol, Azithromycin and vitamins to treat symptoms.  Very limited information has been provided for the event at this time. Based on the mechanism of action of mRNA-1273, the event (Covid-19 pneumonia) is assessed as unlikely related to mRNA-1273. However, all other events are maybe related to COVID infection. Further information has been requested.; Sender's Comments: Very limited information has been provided for the event at this time. Based on the mechanism of action of mRNA-1273, the event (Covid-19 pneumonia) is assessed as unlikely related to mRNA-1273. However, all other events are maybe related to COVID infection. Further information has been requested.
Age: 44.0
Sex: F
Vaccine: COVID19
Symptoms: Headache, Malaise, Myalgia
Clinical narrative: HCP diagnosed low Potassium and "Covid Pneumonia"; did not feel well; Patient lost senses of taste and smell and could not eat. Also had headache, body aches and did not feel well; body aches; could not eat; Patient lost senses of taste; Patient lost senses smell; This spontaneous case was reported by a consumer (subsequently medically confirmed) and describes the occurrence of COVID-19 PNEUMONIA (HCP diagnosed low Potassium and "Covid Pneumonia") in a 44-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 036B21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     The patient's past medical history included COVID-19 virus test negative on 14-Apr-2021.    On 10-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 11-Apr-2021, the patient experienced FEEDING DISORDER (could not eat), AGEUSIA (Patient lost senses of taste) and ANOSMIA (Patient lost senses smell). On 12-Apr-2021, the patient experienced MALAISE (did not feel well), HEADACHE (Patient lost senses of taste and smell and could not eat. Also had headache, body aches and did not feel well) and MYALGIA (body aches). On 14-Apr-2021, the patient experienced COVID-19 PNEUMONIA (HCP diagnosed low Potassium and "Covid Pneumonia") (seriousness criterion medically significant). At the time of the report, COVID-19 PNEUMONIA (HCP diagnosed low Potassium and "Covid Pneumonia"), MALAISE (did not feel well), FEEDING DISORDER (could not eat), AGEUSIA (Patient lost senses of taste), ANOSMIA (Patient lost senses smell), HEADACHE (Patient lost senses of taste and smell and could not eat. Also had headache, body aches and did not feel well) and MYALGIA (body aches) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 14-Apr-2021, Blood potassium: low (Low) Low.     The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       Patient took Tylenol, Azithromycin and vitamins to treat symptoms.  Very limited information has been provided for the event at this time. Based on the mechanism of action of mRNA-1273, the event (Covid-19 pneumonia) is assessed as unlikely related to mRNA-1273. However, all other events are maybe related to COVID infection. Further information has been requested.; Sender's Comments: Very limited information has been provided for the event at this time. Based on the mechanism of action of mRNA-1273, the event (Covid-19 pneumonia) is assessed as unlikely related to mRNA-1273. However, all other events are maybe related to COVID infection. Further information has been requested.
Age: 77.0
Sex: M
Vaccine: COVID19
Symptoms: Crohn's disease, Myalgia
Clinical narrative: Crohn's flare up; body aches; This spontaneous case was reported by an other health care professional and describes the occurrence of CROHN'S DISEASE (Crohn's flare up) in a 77-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.    Co-suspect product included non-company product ADALIMUMAB (HUMIRA) for Crohn's disease.    No relevant past medical history was provided.    On an unknown date, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form and ADALIMUMAB (HUMIRA) (Subcutaneous) 1 dosage form. On an unknown date, the patient experienced CROHN'S DISEASE (Crohn's flare up) (seriousness criterion medically significant) and MYALGIA (body aches). At the time of the report, CROHN'S DISEASE (Crohn's flare up) and MYALGIA (body aches) was resolving.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   concomitant product information was not provided  Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded.; Sender's Comments: Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded.
Age: 58.0
Sex: F
Vaccine: COVID19
Symptoms: Myalgia, Pain, Systemic lupus erythematosus
Clinical narrative: Systemic lupus erythematosus; Generalized Aching; Muscle pain; This spontaneous case was reported by a physician and describes the occurrence of SYSTEMIC LUPUS ERYTHEMATOSUS (Systemic lupus erythematosus) in a 58-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.    Co-suspect product included non-company product ADALIMUMAB (HUMIRA) for Panuveitis and Rheumatoid arthritis.    No Medical History information was reported.   On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form and ADALIMUMAB (HUMIRA) (Subcutaneous) dosage form. On an unknown date, the patient experienced SYSTEMIC LUPUS ERYTHEMATOSUS (Systemic lupus erythematosus) (seriousness criterion medically significant), PAIN (Generalized Aching) and MYALGIA (Muscle pain). At the time of the report, SYSTEMIC LUPUS ERYTHEMATOSUS (Systemic lupus erythematosus) had not resolved and PAIN (Generalized Aching) and MYALGIA (Muscle pain) was resolving.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   On an unknown date,patient experienced lupus.In 2021,the patient experienced body aches and muscle sore.COVID-19 vaccine was also considered as suspect. The patient had lupus.After taking the Moderna vaccine,she experienced a lot of body aches and her muscles were really sore. Daily dose of Humira was citrate free. Concomitant product use was not provided by the reporter. Treatment information was not provided.  Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded.; Sender's Comments: Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded.
Age: 56.0
Sex: F
Vaccine: COVID19
Symptoms: Decreased appetite, Feeling abnormal, Headache, Hypersomnia, Palpitations
Clinical narrative: heart racing which patient to be admitted caused admitted to hospital; slept day and night; thought she was going to die; not eating; severe headaches; This spontaneous case was reported by a consumer and describes the occurrence of PALPITATIONS (heart racing which patient to be admitted caused admitted to hospital) in a 56-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.     No Medical History information was reported.    On an unknown date, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 07-May-2021, the patient experienced PALPITATIONS (heart racing which patient to be admitted caused admitted to hospital) (seriousness criterion hospitalization). On an unknown date, the patient experienced HYPERSOMNIA (slept day and night), FEELING ABNORMAL (thought she was going to die), DECREASED APPETITE (not eating) and HEADACHE (severe headaches). The patient was hospitalized on 07-May-2021 due to PALPITATIONS. At the time of the report, PALPITATIONS (heart racing which patient to be admitted caused admitted to hospital), HYPERSOMNIA (slept day and night), FEELING ABNORMAL (thought she was going to die), DECREASED APPETITE (not eating) and HEADACHE (severe headaches) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Concomitant medication and treatment information were not reported.  Patient's mother state that the patient had vaccine a week ago (Date unknown). On an unknown date the patient had severe headaches, slept day and night, not eating, thought she was going to die and heart racing which caused admitted to hospital on 07-May-2021.; 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: 18.0
Sex: M
Vaccine: COVID19
Symptoms: Electrocardiogram, Electrocardiogram abnormal, Hospitalisation, Laboratory test abnormal
Clinical narrative: Admitted to the hospital after receiving the Moderna shot; Abnormal ECG; Laboratory test abnormal; This spontaneous case was reported by a consumer (subsequently medically confirmed) and describes the occurrence of HOSPITALISATION (Admitted to the hospital after receiving the Moderna shot) in an 18-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.    On 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 HOSPITALISATION (Admitted to the hospital after receiving the Moderna shot) (seriousness criterion hospitalization), ELECTROCARDIOGRAM ABNORMAL (Abnormal ECG) and LABORATORY TEST ABNORMAL (Laboratory test abnormal). At the time of the report, HOSPITALISATION (Admitted to the hospital after receiving the Moderna shot), ELECTROCARDIOGRAM ABNORMAL (Abnormal ECG) and LABORATORY TEST ABNORMAL (Laboratory test abnormal) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, Electrocardiogram: abnormal (abnormal) Abnormal.     The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       Concomitant product use was not provided by the reporter.  Treatment information was not provided.  Company Comment - Very limited information regarding this event/s has been provided at this time.  Further information has been requested.; Sender's Comments: Very limited information regarding this event/s has been provided at this time.  Further information has been requested.
Sex: F
Vaccine: COVID19
Symptoms: Cerebrovascular accident, Dysgraphia, Gait disturbance, Mental impairment
Clinical narrative: Felt like having a stroke; Could not think correctly; Could not write with right hand; hard to ambulate; This spontaneous case was reported by a consumer and describes the occurrence of CEREBROVASCULAR ACCIDENT (Felt like having a stroke) and MENTAL IMPAIRMENT (Could not think correctly) in a female patient of an unknown age 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 06-Apr-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced CEREBROVASCULAR ACCIDENT (Felt like having a stroke) (seriousness criterion medically significant), MENTAL IMPAIRMENT (Could not think correctly) (seriousness criterion medically significant), DYSGRAPHIA (Could not write with right hand) and GAIT DISTURBANCE (hard to ambulate). At the time of the report, CEREBROVASCULAR ACCIDENT (Felt like having a stroke), MENTAL IMPAIRMENT (Could not think correctly), DYSGRAPHIA (Could not write with right hand) and GAIT DISTURBANCE (hard to ambulate) had resolved.            Concomitant medications included a unspecified high dose steroid prior to receiving the vaccine. The patient confirmed with a Pulmonologist and received permission to receive the vaccine.   Treatment information was not reported.  On unknown date, a few days post-vaccination, the patient experienced stroke like symptoms. The patient reported experiencing difficulty ambulating, could not write with right hand and was not able to think clearly for at least 3 days.  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.   Reporter did not allow further contact; 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: 32.0
Sex: U
Vaccine: HEPA
Symptoms: Expired product administered, No adverse event
Clinical narrative: No additional AE reported; patient received a dose of VAQTA on 4/26/2021 that had a labeled expiry of 4/15/2021; This spontaneous report was received from a certified medical assistant and refers to a 32-year-old patient. There was no information about patient's pertinent medical history, drug reactions, allergies and concomitant medications. On 26-APR-2021, the patient was vaccinated with an expired dose of hepatitis a vaccine, inactivated (VAQTA) at a dose of 1 ml, lot # T014590, lot # 15-APR-2021, both confirmed to be valid for for prophylaxis (strength, dose #, route of administration and anatomical location were not reported). No additional adverse events reported. combinationproductreport: Yes; brandname: VAQTA SYRINGE (DEVICE); commondevicename: Hepatitis A Vaccine, Inactivated; productcode: FMF; devicetype: SYRINGE, PISTON (FMF); manufacturername: Merck Sharp & Dohme Corp.; devicelotnumber: T014590; expirationdate: 15-APR-2021; deviceage and unit: 0 ; malfunction: Unknown; deviceusage: Initial; reasonfornoneval: 81 Other; labeledsingleusedevice: No; mdcpreportability: No; mdcpreprationale: Case information does not meet the criteria for Reportability
Sex: U
Vaccine: MMRV
Symptoms: No adverse event, Product storage error
Clinical narrative: No Additional adverse effect; PROQUAD that underwent a temperature excursion was administered; This spontaneous report was received from  a registered nurse concerning to a patient of unknown age and gender.  Information regarding the patient's pertinent medical history, drug reactions, allergies, and concomitant therapies were not reported.  On 30-APR-2021, the patient was vaccinated with an improperly stored dose of measles, mumps, rubella and varicella (oka-merck) virus vaccine live (rHA) (PROQUAD) (dose, route of administration, lot number T027118 has been verified to be valid; expiration date reported and validated as 07-FEB-2022) for prophylaxis (dose number and vaccination scheme were not provided).  Temperature excursion was reported with temperatures between -10 degrees Celsius to 8 degrees Celsius with average of 8 degrees Celsius. The total frame time out of range was for 842 hours and 30 minutes, there was no previous temperature excursion. No digital data logger was involved.  No additional adverse effect was reported.
Sex: U
Vaccine: RV5
Symptoms: No adverse event, Product storage error
Clinical narrative: no additional adverse events; A patient in their clinic was inadvertently administered an expired dose of ROTATEQ; This spontaneous report was received from a medical assistant referring to a patient of unknown age and gender. The patient's medical history, historical drugs, concurrent conditions and concomitant medications were not provided.       On 10-MAY-2021, the patient was vaccinated with an expired dose of rotavirus vaccine, live, oral, pentavalent(ROTATEQ) 2 milliliter, oral, lot number 1660994, expiration date 01-MAY-2021 for prophylaxis. The vaccine had not undergone any temperature excursion. No adverse event was reported.
Age: 56.0
Sex: U
Vaccine: VARZOS
Symptoms: Balance disorder, Cerebrovascular accident, Post herpetic neuralgia, Visual impairment
Clinical narrative: stroke; post herpetic neuralgia; vision problems; balance problems; This initial spontaneous report was received from a lawyer regarding a case in litigation, referring to a adult patient of unknown gender. No information was provided regarding medical history, concurrent conditions, or concomitant medications. On or about 08-MAY-2014, the patient was vaccinated with zoster vaccine live (ZOSTAVAX) for the long-term prevention of shingles and/or zoster-related conditions (strength, dose, route of administration, anatomical location, lot number, and expiration date were not reported). On an unknown date, reported as subsequent to the vaccination, the patient was treated for stroke, postherpetic neuralgia, vision problems and balance problems. The outcome of stroke, postherpetic neuralgia, vision problems and balance problems were not reported. The reporter considered stroke, postherpetic neuralgia, vision problems and balance problems to be related to zoster vaccine live (ZOSTAVAX).  Upon internal review, cerebrovascular accident was determined to be a medically significant event.
Sex: F
Vaccine: MMR
Symptoms: Immune thrombocytopenia
Clinical narrative: developed ITP; This spontaneous report was received from a consumer referring to a 5 years old female patient. The patient's concurrent condition, medical history and concomitant therapies were not reported.  On an unknown date, the patient was vaccinated with measles, mumps, and rubella (wistar ra 27-3) virus vaccine, live (manufacturer unknown) for prophylaxis (strength, dose, frequency, route of administration, lot number and expiration date were not reported).  In approximately 2004, the patient experienced an adverse reaction to measles, mumps, and rubella (wistar ra 27-3) virus vaccine, live (manufacturer unknown), which was immune thrombocytopenic purpura (ITP). The outcome of the event was not reported.  Upon internal review, ITP was determined to be medically significant.
Sex: U
Vaccine: VARZOS
Symptoms: Deafness, Ill-defined disorder
Clinical narrative: hearing loss; Other zoster-related conditions; This spontaneous report was received from a lawyer referring to a patient (pt) of unknown age and gender. The pt's pertinent medical history, concurrent conditions and concomitant medications were not provided.     On or about 16-MAR-2017, the patient was vaccinated with zoster vaccine live (ZOSTAVAX) for the long-term prevention of shingles and zoster-related conditions (strength, dose, route of administration, anatomical location, lot # and expiration date were not reported).  Subsequent, on an unknown date, pt was treated by a healthcare provider, including a physician, for hearing loss (deafness) and other zoster-related conditions (ill-defined disorder). As a direct and proximate result of pt's use of the zoster vaccine live (ZOSTAVAX) vaccine, pt had and would continue suffer ongoing injuries, including but not limited to mental and physician pain and suffering medical care and treatment for these injuries; significant medical and related expenses as a result of these injuries, including but not limited to medical losses and cost included care for hospitalization, physician care, monitoring, treatment, medication and supplies; diminished capacity for the enjoyment of life; diminished quality of life; increased risk of premature death, aggravation of preexisting conditions and activation of latent conditions; and other losses and damages; and would continue to suffer such losses, and damages in the future.   Upon internal review, deafness was considered a medically significant event.
Sex: U
Vaccine: RV5
Symptoms: Product storage error
Clinical narrative: No other AEs; a temperature excursion on ROTATEQ that was administered; This spontaneous report was received from a medical assistant and refers to a patient of unknown age and gender. There was no information about the patient's pertinent medical history, drug reactions, allergies and concomitant medications.   On 22-APR-2021, the patient was vaccinated with an improperly stored rotavirus vaccine, live, oral, pentavalent (ROTATEQ) 1 time dose, route defaulted to oral, lot # T033812, has been confirmed to be a valid lot #, expiration date 29-DEC-2021) (exact dose, route of administration and anatomical location were not provided), for prophylaxis. Administered dose of vaccine experienced temperature excursion of 48.2 degrees Fahrenheit (above 47 degrees Fahrenheit) for 2 hours. There was no adverse event reported. Data logger was not involved. There were no previous excursions reported.  This is one of three reports received from the same reporter.; Sender's Comments:  US-009507513-2104USA007514:
Age: 56.0
Sex: F
Vaccine: PPV
Symptoms: Urticaria
Clinical narrative: Hives; This spontaneous report was received from an adult female patient, concerning to herself via a plaintiff Fact Sheet from a case in litigation for zoster vaccine live (ZOSTAVAX) (Marrs# 2101USA001807). The patient's medical history, previous drug reactions or allergies and concomitant medications were not reported.     On and unspecified date in 2003, the patient was vaccinated with pneumococcal vaccine, polyvalent (23-valent) (manufacturer unknown) (reported as "pneumonia") for prophylaxis (strength, dose, route of administration, anatomical location, lot # and expiration date were not provided).  On an unknown date, the patient experienced hives (urticaria).   The outcome of urticaria and the causality assessment between pneumococcal vaccine, polyvalent (23-valent) (manufacturer unknown) and the aforementioned event were not reported.  This is one of two reports received from the same patient.; Sender's Comments:  US-009507513-2101USA001807:
Age: 49.0
Sex: M
Vaccine: COVID19
Symptoms: Dizziness, Loss of consciousness, Palpitations, Tinnitus
Clinical narrative: Pt was sitting in post-vaccinating area after a covid shot. Suddenly he felt his heart racing, started hearing noises, feeling dizziness, and he passed out briefly.
Age: 46.0
Sex: F
Vaccine: COVID19
Symptoms: Extra dose administered
Clinical narrative: Patient received 3 doses of Pfizer Dose 1: 03/22/21 Lot EN6199 Dose 2: 04/12/2021 Lot EW0162
Age: 19.0
Sex: M
Vaccine: COVID19
Symptoms: Aspartate aminotransferase increased, Blood creatinine normal, Chest pain, Decreased appetite, Dizziness
Clinical narrative: After having the shot, hedeveloped left arm pain and did develop some lymphadenopathy in his left axillary region.  He was dealing with nausea and dizziness, and the following day, he went to work, although he was feeling a bit ill.  While at work, he was found to have a fever, so he was sent home.  He has been having hot and cold flashes since then.  He has had a poor appetite.  He has had a dry mouth and trouble sleeping.  One day prior to admission, he then developed a chest pain that became constant and persisted, so he came into the emergency department on 05/19/2021 for further care. He has developed myocarditis after receiving the first of his Moderna Coronavirus Disease 19 vaccines.
Age: 19.0
Sex: M
Vaccine: COVID19
Symptoms: Dry mouth, Feeling of body temperature change, Fibrin D dimer increased, Haematocrit normal, Liver function test normal
Clinical narrative: After having the shot, hedeveloped left arm pain and did develop some lymphadenopathy in his left axillary region.  He was dealing with nausea and dizziness, and the following day, he went to work, although he was feeling a bit ill.  While at work, he was found to have a fever, so he was sent home.  He has been having hot and cold flashes since then.  He has had a poor appetite.  He has had a dry mouth and trouble sleeping.  One day prior to admission, he then developed a chest pain that became constant and persisted, so he came into the emergency department on 05/19/2021 for further care. He has developed myocarditis after receiving the first of his Moderna Coronavirus Disease 19 vaccines.
Age: 19.0
Sex: M
Vaccine: COVID19
Symptoms: Lymphadenopathy, Malaise, Myocarditis, Nausea, Pain in extremity
Clinical narrative: After having the shot, hedeveloped left arm pain and did develop some lymphadenopathy in his left axillary region.  He was dealing with nausea and dizziness, and the following day, he went to work, although he was feeling a bit ill.  While at work, he was found to have a fever, so he was sent home.  He has been having hot and cold flashes since then.  He has had a poor appetite.  He has had a dry mouth and trouble sleeping.  One day prior to admission, he then developed a chest pain that became constant and persisted, so he came into the emergency department on 05/19/2021 for further care. He has developed myocarditis after receiving the first of his Moderna Coronavirus Disease 19 vaccines.
Age: 19.0
Sex: M
Vaccine: COVID19
Symptoms: Platelet count normal, Pyrexia, SARS-CoV-2 test negative, Sleep disorder, Troponin increased
Clinical narrative: After having the shot, hedeveloped left arm pain and did develop some lymphadenopathy in his left axillary region.  He was dealing with nausea and dizziness, and the following day, he went to work, although he was feeling a bit ill.  While at work, he was found to have a fever, so he was sent home.  He has been having hot and cold flashes since then.  He has had a poor appetite.  He has had a dry mouth and trouble sleeping.  One day prior to admission, he then developed a chest pain that became constant and persisted, so he came into the emergency department on 05/19/2021 for further care. He has developed myocarditis after receiving the first of his Moderna Coronavirus Disease 19 vaccines.
Age: 19.0
Sex: M
Vaccine: COVID19
Symptoms: White blood cell count normal
Clinical narrative: After having the shot, hedeveloped left arm pain and did develop some lymphadenopathy in his left axillary region.  He was dealing with nausea and dizziness, and the following day, he went to work, although he was feeling a bit ill.  While at work, he was found to have a fever, so he was sent home.  He has been having hot and cold flashes since then.  He has had a poor appetite.  He has had a dry mouth and trouble sleeping.  One day prior to admission, he then developed a chest pain that became constant and persisted, so he came into the emergency department on 05/19/2021 for further care. He has developed myocarditis after receiving the first of his Moderna Coronavirus Disease 19 vaccines.
Age: 54.0
Sex: F
Vaccine: COVID19
Symptoms: Blood test, Condition aggravated, Diarrhoea, Ear congestion, Nausea
Clinical narrative: My throat started to get tight and I started wheezing. I also had hives all over my abdomen. I became nauseous and my esophagus spasmed. Acid started coming up my throat so I tried not to throw up. My ears and sinus' filled with mucous and fluid. I took a H2 Blocker 40mg. The reaction to the vaccine has lasted 5 weeks. It triggered my Mast Cell and I am having a constant response daily. I was experiencing diarrhea and throwing up also. My heart condition has calmed down though.
Age: 54.0
Sex: F
Vaccine: COVID19
Symptoms: Oesophageal spasm, Reflux laryngitis, Sinus congestion, Throat tightness, Urticaria
Clinical narrative: My throat started to get tight and I started wheezing. I also had hives all over my abdomen. I became nauseous and my esophagus spasmed. Acid started coming up my throat so I tried not to throw up. My ears and sinus' filled with mucous and fluid. I took a H2 Blocker 40mg. The reaction to the vaccine has lasted 5 weeks. It triggered my Mast Cell and I am having a constant response daily. I was experiencing diarrhea and throwing up also. My heart condition has calmed down though.
Age: 54.0
Sex: F
Vaccine: COVID19
Symptoms: Vomiting, Wheezing
Clinical narrative: My throat started to get tight and I started wheezing. I also had hives all over my abdomen. I became nauseous and my esophagus spasmed. Acid started coming up my throat so I tried not to throw up. My ears and sinus' filled with mucous and fluid. I took a H2 Blocker 40mg. The reaction to the vaccine has lasted 5 weeks. It triggered my Mast Cell and I am having a constant response daily. I was experiencing diarrhea and throwing up also. My heart condition has calmed down though.