chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 37.0
Sex: F
Vaccine: COVID19, COVID19, COVID19, COVID19
Symptoms: Extra dose administered, Product administration error
Clinical narrative: DRUG ADMINISTRATION ERROR; POSSIBLE EXTRA DOSE ADMINISTERED; This spontaneous report received from a patient concerned a 37 year old female. The patient's concurrent conditions included inflamed nerves, non-alcoholic, and non-smoker, and other pre-existing medical conditions included patient had no known allergies and no history of drug abuse. The patient was previously treated with gabapentin for inflamed nerves. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 1805018, and expiry: 25/MAY/2021) dose was not reported, administered on 10-MAR-2021 05:15 for prophylactic vaccination. No concomitant medications were reported.  On MAR-2021, Laboratory data included: HIV infection (NR: not provided) not reported, and Hepatitis (NR: not provided) not reported. On 10-MAR-2021, the subject experienced drug administration error. On 10-MAR-2021, the subject experienced possible extra dose administered. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the drug administration error and possible extra dose administered was not reported. This report was non-serious. This report was associated with product quality complaint: 90000173646.; Sender's Comments: V1: Follow up information received in the current version has no impact on previous assessment. Medical assessment comment not required as per standard procedure as the case assessed as non-serious.
Age: 37.0
Sex: F
Vaccine: COVID19, COVID19, COVID19, COVID19
Symptoms: Extra dose administered, HIV infection, Hepatitis, Product administration error
Clinical narrative: DRUG ADMINISTRATION ERROR; POSSIBLE EXTRA DOSE ADMINISTERED; This spontaneous report received from a patient concerned a 37 year old female. The patient's concurrent conditions included inflamed nerves, non-alcoholic, and non-smoker, and other pre-existing medical conditions included patient had no known allergies and no history of drug abuse. The patient was previously treated with gabapentin for inflamed nerves. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 1805018, and expiry: 25/MAY/2021) dose was not reported, administered on 10-MAR-2021 05:15 for prophylactic vaccination. No concomitant medications were reported.  On MAR-2021, Laboratory data included: HIV infection (NR: not provided) not reported, and Hepatitis (NR: not provided) not reported. On 10-MAR-2021, the subject experienced drug administration error. On 10-MAR-2021, the subject experienced possible extra dose administered. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the drug administration error and possible extra dose administered was not reported. This report was non-serious. This report was associated with product quality complaint: 90000173646.; Sender's Comments: V1: Follow up information received in the current version has no impact on previous assessment. Medical assessment comment not required as per standard procedure as the case assessed as non-serious.
Age: 37.0
Sex: F
Vaccine: COVID19, COVID19, COVID19, COVID19
Symptoms: Immunisation, Syringe issue
Clinical narrative: DRUG ADMINISTRATION ERROR; POSSIBLE EXTRA DOSE ADMINISTERED; This spontaneous report received from a patient concerned a 37 year old female. The patient's concurrent conditions included inflamed nerves, non-alcoholic, and non-smoker, and other pre-existing medical conditions included patient had no known allergies and no history of drug abuse. The patient was previously treated with gabapentin for inflamed nerves. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 1805018, and expiry: 25/MAY/2021) dose was not reported, administered on 10-MAR-2021 05:15 for prophylactic vaccination. No concomitant medications were reported.  On MAR-2021, Laboratory data included: HIV infection (NR: not provided) not reported, and Hepatitis (NR: not provided) not reported. On 10-MAR-2021, the subject experienced drug administration error. On 10-MAR-2021, the subject experienced possible extra dose administered. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the drug administration error and possible extra dose administered was not reported. This report was non-serious. This report was associated with product quality complaint: 90000173646.; Sender's Comments: V1: Follow up information received in the current version has no impact on previous assessment. Medical assessment comment not required as per standard procedure as the case assessed as non-serious.
Age: 28.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: COVID-19, SARS-CoV-2 test positive
Clinical narrative: TIREDNESS; MUSCLE ACHES; SORE THROAT; NASAL CONGESTION; CHEST CONGESTION; BODY ACHES; MILD FEVER OF 99.3; HEADACHE; This spontaneous report received from a patient concerned a 28 year old male. The patient's weight was 160 pounds, and height was 180.34 centimeters. The patient's pre-existing medical conditions included the patient had no allergies and no family history of disease relevant to vaccination. the patient had no illness at the time of vaccination or no history of similar event. the patient had no adverse event after any previous vaccinations. the patient reported to have no pre-existing acute illness 30 days prior to vaccination and no history of hospitalization in last 30 days. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: Unknown) dose was not reported, administered on 07-MAR-2021 at right arm for prophylactic vaccination. The batch number was not reported and has been requested. No concomitant medications were reported. On MAR-2021, the subject experienced sore throat. On MAR-2021, the subject experienced nasal congestion. On MAR-2021, the subject experienced chest congestion. On MAR-2021, the subject experienced body aches. On MAR-2021, the subject experienced mild fever of 99.3. On MAR-2021, the subject experienced headache. Laboratory data included: Body temperature (NR: not provided) 99.3 F. On 08-MAR-2021, the subject experienced tiredness. On 08-MAR-2021, the subject experienced muscle aches. On 19-MAR-2021, Laboratory data included: COVID-19 antigen test (NR: not provided) Positive, and COVID-19 molecular test (NR: not provided) Negative. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from tiredness, and muscle aches, and the outcome of sore throat, headache, mild fever of 99.3, nasal congestion, chest congestion and body aches was not reported. This report was non-serious. This case was associated with product quality complaint number : 90000173743 The suspected product quality complaint has been confirmed to be void (confirmed no pqc was identified within the reported complaint reported) based on the PQC evaluation/investigation performed.; Sender's Comments: V2: Medical assessment comment not required as per standard procedure as the case was assessed as non-serious.
Age: 28.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Body temperature, Fatigue, Headache, Myalgia, Nasal congestion
Clinical narrative: TIREDNESS; MUSCLE ACHES; SORE THROAT; NASAL CONGESTION; CHEST CONGESTION; BODY ACHES; MILD FEVER OF 99.3; HEADACHE; This spontaneous report received from a patient concerned a 28 year old male. The patient's weight was 160 pounds, and height was 180.34 centimeters. The patient's pre-existing medical conditions included the patient had no allergies and no family history of disease relevant to vaccination. the patient had no illness at the time of vaccination or no history of similar event. the patient had no adverse event after any previous vaccinations. the patient reported to have no pre-existing acute illness 30 days prior to vaccination and no history of hospitalization in last 30 days. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: Unknown) dose was not reported, administered on 07-MAR-2021 at right arm for prophylactic vaccination. The batch number was not reported and has been requested. No concomitant medications were reported. On MAR-2021, the subject experienced sore throat. On MAR-2021, the subject experienced nasal congestion. On MAR-2021, the subject experienced chest congestion. On MAR-2021, the subject experienced body aches. On MAR-2021, the subject experienced mild fever of 99.3. On MAR-2021, the subject experienced headache. Laboratory data included: Body temperature (NR: not provided) 99.3 F. On 08-MAR-2021, the subject experienced tiredness. On 08-MAR-2021, the subject experienced muscle aches. On 19-MAR-2021, Laboratory data included: COVID-19 antigen test (NR: not provided) Positive, and COVID-19 molecular test (NR: not provided) Negative. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from tiredness, and muscle aches, and the outcome of sore throat, headache, mild fever of 99.3, nasal congestion, chest congestion and body aches was not reported. This report was non-serious. This case was associated with product quality complaint number : 90000173743 The suspected product quality complaint has been confirmed to be void (confirmed no pqc was identified within the reported complaint reported) based on the PQC evaluation/investigation performed.; Sender's Comments: V2: Medical assessment comment not required as per standard procedure as the case was assessed as non-serious.
Age: 28.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Oropharyngeal pain, Pain, Pyrexia, Respiratory tract congestion, SARS-CoV-2 test
Clinical narrative: TIREDNESS; MUSCLE ACHES; SORE THROAT; NASAL CONGESTION; CHEST CONGESTION; BODY ACHES; MILD FEVER OF 99.3; HEADACHE; This spontaneous report received from a patient concerned a 28 year old male. The patient's weight was 160 pounds, and height was 180.34 centimeters. The patient's pre-existing medical conditions included the patient had no allergies and no family history of disease relevant to vaccination. the patient had no illness at the time of vaccination or no history of similar event. the patient had no adverse event after any previous vaccinations. the patient reported to have no pre-existing acute illness 30 days prior to vaccination and no history of hospitalization in last 30 days. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: Unknown) dose was not reported, administered on 07-MAR-2021 at right arm for prophylactic vaccination. The batch number was not reported and has been requested. No concomitant medications were reported. On MAR-2021, the subject experienced sore throat. On MAR-2021, the subject experienced nasal congestion. On MAR-2021, the subject experienced chest congestion. On MAR-2021, the subject experienced body aches. On MAR-2021, the subject experienced mild fever of 99.3. On MAR-2021, the subject experienced headache. Laboratory data included: Body temperature (NR: not provided) 99.3 F. On 08-MAR-2021, the subject experienced tiredness. On 08-MAR-2021, the subject experienced muscle aches. On 19-MAR-2021, Laboratory data included: COVID-19 antigen test (NR: not provided) Positive, and COVID-19 molecular test (NR: not provided) Negative. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from tiredness, and muscle aches, and the outcome of sore throat, headache, mild fever of 99.3, nasal congestion, chest congestion and body aches was not reported. This report was non-serious. This case was associated with product quality complaint number : 90000173743 The suspected product quality complaint has been confirmed to be void (confirmed no pqc was identified within the reported complaint reported) based on the PQC evaluation/investigation performed.; Sender's Comments: V2: Medical assessment comment not required as per standard procedure as the case was assessed as non-serious.
Age: 66.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Death, Dyspnoea, Epistaxis, Mouth haemorrhage, Pyrexia
Clinical narrative: On 3/18/2021 afternoon, my husband did 2nd Moderna dose as schedule, which was 42 days later after 1st dose. When he came back home, I asked to him what's his feeling. He said ok, just a little bit soreness on his arm. On Friday (3/19/2021) afternoon he back from office, I asked to him again any feeling. He said a little more soreness on his arm and feel a little bit fever (low temperature). He went to bed around 11pm. He told me feel cold. I put one more blanket on our comforter and he slept close to a small heater.   Around 2:10am (3/20/2021) I was awake by his heavy breathing. I turned on the lamp. I saw he breath heavily and exhale saliva with blood. I tried to wake him up. But seems he was still in sleep. I thought it's vaccine's side effect. In a while, his breath changed to lighter, not so heavy. I thought it's recover. And I wipe his blood saliva. It's back and forth a while from heavily breath to lighter, and no blood saliva any more. And his body was more sweat. I wipe it out multiple times. But I didn't see him wake up. Around 4am, I felt his breath seems normal and he slept well. I thought it's vaccine's action. And I did check his pulse frequently. it's normal. I did sleep then.  Around 5am, I was wake up by another high roar of him. I found him roar highly and lowly again. I called him, but he didn't response. I thought he was in sleep still. Vaccine worked on his body again. After a while, he seems back to normal. I slept with him. My hands laid on his face. Around 5:40am, I suddenly found I couldn't feel his pulse.  I called emergency services immediately. Emergency services sent ambulance. At the same time told me to move him from bed to the ground so that i can do CPR. But he was so heavy to move. And ambulanceman came. they checked his heart beat. it's too late. It's a line then.  He passed away.
Age: 66.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Autopsy, Breath sounds abnormal, Death, Dyspnoea, Feeling cold
Clinical narrative: On 3/18/2021 afternoon, my husband did 2nd Moderna dose as schedule, which was 42 days later after 1st dose. When he came back home, I asked to him what's his feeling. He said ok, just a little bit soreness on his arm. On Friday (3/19/2021) afternoon he back from office, I asked to him again any feeling. He said a little more soreness on his arm and feel a little bit fever (low temperature). He went to bed around 11pm. He told me feel cold. I put one more blanket on our comforter and he slept close to a small heater.   Around 2:10am (3/20/2021) I was awake by his heavy breathing. I turned on the lamp. I saw he breath heavily and exhale saliva with blood. I tried to wake him up. But seems he was still in sleep. I thought it's vaccine's side effect. In a while, his breath changed to lighter, not so heavy. I thought it's recover. And I wipe his blood saliva. It's back and forth a while from heavily breath to lighter, and no blood saliva any more. And his body was more sweat. I wipe it out multiple times. But I didn't see him wake up. Around 4am, I felt his breath seems normal and he slept well. I thought it's vaccine's action. And I did check his pulse frequently. it's normal. I did sleep then.  Around 5am, I was wake up by another high roar of him. I found him roar highly and lowly again. I called him, but he didn't response. I thought he was in sleep still. Vaccine worked on his body again. After a while, he seems back to normal. I slept with him. My hands laid on his face. Around 5:40am, I suddenly found I couldn't feel his pulse.  I called emergency services immediately. Emergency services sent ambulance. At the same time told me to move him from bed to the ground so that i can do CPR. But he was so heavy to move. And ambulanceman came. they checked his heart beat. it's too late. It's a line then.  He passed away.
Age: 66.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Haemoptysis, Hyperhidrosis, Inappropriate schedule of product administration, Pain in extremity, Pulse absent
Clinical narrative: On 3/18/2021 afternoon, my husband did 2nd Moderna dose as schedule, which was 42 days later after 1st dose. When he came back home, I asked to him what's his feeling. He said ok, just a little bit soreness on his arm. On Friday (3/19/2021) afternoon he back from office, I asked to him again any feeling. He said a little more soreness on his arm and feel a little bit fever (low temperature). He went to bed around 11pm. He told me feel cold. I put one more blanket on our comforter and he slept close to a small heater.   Around 2:10am (3/20/2021) I was awake by his heavy breathing. I turned on the lamp. I saw he breath heavily and exhale saliva with blood. I tried to wake him up. But seems he was still in sleep. I thought it's vaccine's side effect. In a while, his breath changed to lighter, not so heavy. I thought it's recover. And I wipe his blood saliva. It's back and forth a while from heavily breath to lighter, and no blood saliva any more. And his body was more sweat. I wipe it out multiple times. But I didn't see him wake up. Around 4am, I felt his breath seems normal and he slept well. I thought it's vaccine's action. And I did check his pulse frequently. it's normal. I did sleep then.  Around 5am, I was wake up by another high roar of him. I found him roar highly and lowly again. I called him, but he didn't response. I thought he was in sleep still. Vaccine worked on his body again. After a while, he seems back to normal. I slept with him. My hands laid on his face. Around 5:40am, I suddenly found I couldn't feel his pulse.  I called emergency services immediately. Emergency services sent ambulance. At the same time told me to move him from bed to the ground so that i can do CPR. But he was so heavy to move. And ambulanceman came. they checked his heart beat. it's too late. It's a line then.  He passed away.
Age: 66.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Pulseless electrical activity, Pyrexia, Respiration abnormal, Saliva altered, Unresponsive to stimuli
Clinical narrative: On 3/18/2021 afternoon, my husband did 2nd Moderna dose as schedule, which was 42 days later after 1st dose. When he came back home, I asked to him what's his feeling. He said ok, just a little bit soreness on his arm. On Friday (3/19/2021) afternoon he back from office, I asked to him again any feeling. He said a little more soreness on his arm and feel a little bit fever (low temperature). He went to bed around 11pm. He told me feel cold. I put one more blanket on our comforter and he slept close to a small heater.   Around 2:10am (3/20/2021) I was awake by his heavy breathing. I turned on the lamp. I saw he breath heavily and exhale saliva with blood. I tried to wake him up. But seems he was still in sleep. I thought it's vaccine's side effect. In a while, his breath changed to lighter, not so heavy. I thought it's recover. And I wipe his blood saliva. It's back and forth a while from heavily breath to lighter, and no blood saliva any more. And his body was more sweat. I wipe it out multiple times. But I didn't see him wake up. Around 4am, I felt his breath seems normal and he slept well. I thought it's vaccine's action. And I did check his pulse frequently. it's normal. I did sleep then.  Around 5am, I was wake up by another high roar of him. I found him roar highly and lowly again. I called him, but he didn't response. I thought he was in sleep still. Vaccine worked on his body again. After a while, he seems back to normal. I slept with him. My hands laid on his face. Around 5:40am, I suddenly found I couldn't feel his pulse.  I called emergency services immediately. Emergency services sent ambulance. At the same time told me to move him from bed to the ground so that i can do CPR. But he was so heavy to move. And ambulanceman came. they checked his heart beat. it's too late. It's a line then.  He passed away.
Age: 52.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Arthralgia, Blood test normal, Chills, Dizziness, Fatigue
Clinical narrative: Patient had confirmed antibodies, via a blood test, as recently as 2.26.21. She was vaccinated on 3.12.21. Since then she was debilitated. Dizzy, headache, low grade temp, aches and pains, joint pain and complete exhaustion. she has  been in bed or on the couch for 3.5 weeks.  saw PCP who did labs and sent her to an immunologist. She is currently under his care now
Age: 52.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Headache, Influenza like illness, Pain, Staring
Clinical narrative: Patient had confirmed antibodies, via a blood test, as recently as 2.26.21. She was vaccinated on 3.12.21. Since then she was debilitated. Dizzy, headache, low grade temp, aches and pains, joint pain and complete exhaustion. she has  been in bed or on the couch for 3.5 weeks.  saw PCP who did labs and sent her to an immunologist. She is currently under his care now
Age: 52.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Arthralgia, Blood test, Dizziness, Fatigue, Headache
Clinical narrative: Patient had confirmed antibodies, via a blood test, as recently as 2.26.21. She was vaccinated on 3.12.21. Since then she was debilitated. Dizzy, headache, low grade temp, aches and pains, joint pain and complete exhaustion. she has  been in bed or on the couch for 3.5 weeks.  saw PCP who did labs and sent her to an immunologist. She is currently under his care now
Age: 52.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Pain, Pyrexia
Clinical narrative: Patient had confirmed antibodies, via a blood test, as recently as 2.26.21. She was vaccinated on 3.12.21. Since then she was debilitated. Dizzy, headache, low grade temp, aches and pains, joint pain and complete exhaustion. she has  been in bed or on the couch for 3.5 weeks.  saw PCP who did labs and sent her to an immunologist. She is currently under his care now
Age: 61.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Needle issue, Underdose
Clinical narrative: PARTIAL DOSE ADMINISTERED; SYRINGE LEAKAGE; FAULTY NEEDLE (HOLE AND HUB); This spontaneous report received from a vaccine facility concerned a 61 year old male. The patient's weight was 202 pounds, and height was not reported. The patient's concurrent conditions included alcohol user, and smoker, and other pre-existing medical conditions included the patient had no allergies and no history of drug abuse. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, intramuscular, batch number: 1808069, and batch number: 1808069 expiry: 09-JUNE-2021) .5 ml, administered on 23-MAR-2021 for prophylactic vaccination on right arm. No concomitant medications were reported. On 23-MAR-2021, the subject experienced partial dose administered. On 23-MAR-2021, the subject experienced syringe leakage. On 23-MAR-2021, the subject experienced faulty needle (hole and hub). The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from syringe leakage, and faulty needle (hole and hub), and had not recovered from partial dose administered. This report was non-serious. The suspected product quality complaint has been confirmed to be confirmed no pqc was identified within the reported complaint reported. complaint is approved for void. based on the PQC evaluation/investigation performed. This report was associated with product quality complaint : 90000174195
Age: 61.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Needle issue, Syringe issue, Underdose
Clinical narrative: PARTIAL DOSE ADMINISTERED; SYRINGE LEAKAGE; FAULTY NEEDLE (HOLE AND HUB); This spontaneous report received from a vaccine facility concerned a 61 year old male. The patient's weight was 202 pounds, and height was not reported. The patient's concurrent conditions included alcohol user, and smoker, and other pre-existing medical conditions included the patient had no allergies and no history of drug abuse. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, intramuscular, batch number: 1808069, and batch number: 1808069 expiry: 09-JUNE-2021) .5 ml, administered on 23-MAR-2021 for prophylactic vaccination on right arm. No concomitant medications were reported. On 23-MAR-2021, the subject experienced partial dose administered. On 23-MAR-2021, the subject experienced syringe leakage. On 23-MAR-2021, the subject experienced faulty needle (hole and hub). The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from syringe leakage, and faulty needle (hole and hub), and had not recovered from partial dose administered. This report was non-serious. The suspected product quality complaint has been confirmed to be confirmed no pqc was identified within the reported complaint reported. complaint is approved for void. based on the PQC evaluation/investigation performed. This report was associated with product quality complaint : 90000174195
Age: 73.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Chest pain, Death, Vomiting
Clinical narrative: Shortness of Breath, vomiting-Death
Age: 73.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Death, Dyspnoea, Vomiting
Clinical narrative: Shortness of Breath, vomiting-Death
Age: 68.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Hypoaesthesia oral, Pruritus
Clinical narrative: ITCHY SKIN ALL OVER THE BODY; NUMBNESS IN TONGUE; This spontaneous report received from a patient concerned a 68 year old female. The patient's weight was 200 pounds, and height was 63 inches. The patient's concurrent conditions included hyperactive immune system, environmental allergy, food allergy, pharmaceutical allergy, alcohol user, non smoker, inflammation, hiatal hernia, seasonal allergies, and insulin resistance, and other pre-existing medical conditions included there is no history of drug abuse or illicit drug use. The patient experienced 2 anaphylactic events when treated with urethane. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 1805031, and batch number: 1805031 expiry: UNKNOWN) dose was not reported, 1 total, administered on 13-MAR-2021 13:00 for prophylactic vaccination. Concomitant medications included famotidine for hiatal hernia, metformin for insulin resistance, and levocetirizine dihydrochloride for seasonal allergies. On 13-MAR-2021, the subject experienced itchy skin all over the body. On 13-MAR-2021, the subject experienced numbness in tongue. Treatment medications included: diphenhydramine hydrochloride. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from itchy skin all over the body, and numbness in tongue on 14-MAR-2021. This report was non-serious.  Additional information was received from patient on 29-MAR-2021. Following information was updated and incorporated into the case narrative: other reference numbers, onset date for event numbness in tongue updated, Vaccination time updated. Upon review, following correction was performed in the case: Anaphylaxis to urethane coded as past event past drug format.
Age: 45.0
Sex: F
Vaccine: COVID19, COVID19, COVID19
Symptoms: Blood test, Flank pain, Injection site warmth, Painful respiration, Urinary tract infection
Clinical narrative: Between 5-10 mins after receiving dose, patient started having R sided chest pain and difficulty breathing.  patient was transported the  EC. Blood test, urine test, CT chest w/o contrast.  Was told pulled a muscle while sitting and doing nothing (@ holding area).  Correlation can't be made with any degree of certainty if related to vaccine. Felt burning sensation in arm after receiving vaccine and then pain on right side right under armpit (stabbing sensation).  Every time took a breath in, felt pain.  Patient reported having a hard  time walking.  Wasn't given any medication in EC. Pain was manageable after 5 hours.
Age: 45.0
Sex: F
Vaccine: COVID19, COVID19, COVID19
Symptoms: Urine analysis
Clinical narrative: Between 5-10 mins after receiving dose, patient started having R sided chest pain and difficulty breathing.  patient was transported the  EC. Blood test, urine test, CT chest w/o contrast.  Was told pulled a muscle while sitting and doing nothing (@ holding area).  Correlation can't be made with any degree of certainty if related to vaccine. Felt burning sensation in arm after receiving vaccine and then pain on right side right under armpit (stabbing sensation).  Every time took a breath in, felt pain.  Patient reported having a hard  time walking.  Wasn't given any medication in EC. Pain was manageable after 5 hours.
Age: 45.0
Sex: F
Vaccine: COVID19, COVID19, COVID19
Symptoms: Axillary pain, Burning sensation, Chest pain, Computerised tomogram thorax, Dyspnoea
Clinical narrative: Between 5-10 mins after receiving dose, patient started having R sided chest pain and difficulty breathing.  patient was transported the  EC. Blood test, urine test, CT chest w/o contrast.  Was told pulled a muscle while sitting and doing nothing (@ holding area).  Correlation can't be made with any degree of certainty if related to vaccine. Felt burning sensation in arm after receiving vaccine and then pain on right side right under armpit (stabbing sensation).  Every time took a breath in, felt pain.  Patient reported having a hard  time walking.  Wasn't given any medication in EC. Pain was manageable after 5 hours.
Age: 45.0
Sex: F
Vaccine: COVID19, COVID19, COVID19
Symptoms: Gait disturbance, Laboratory test, Muscle strain, Pain in extremity, Urine analysis
Clinical narrative: Between 5-10 mins after receiving dose, patient started having R sided chest pain and difficulty breathing.  patient was transported the  EC. Blood test, urine test, CT chest w/o contrast.  Was told pulled a muscle while sitting and doing nothing (@ holding area).  Correlation can't be made with any degree of certainty if related to vaccine. Felt burning sensation in arm after receiving vaccine and then pain on right side right under armpit (stabbing sensation).  Every time took a breath in, felt pain.  Patient reported having a hard  time walking.  Wasn't given any medication in EC. Pain was manageable after 5 hours.
Age: 45.0
Sex: F
Vaccine: COVID19, COVID19, COVID19
Symptoms: Condition aggravated, Dyspnoea, Flank pain, Muscle strain, Urinary tract infection
Clinical narrative: Between 5-10 mins after receiving dose, patient started having R sided chest pain and difficulty breathing.  patient was transported the  EC. Blood test, urine test, CT chest w/o contrast.  Was told pulled a muscle while sitting and doing nothing (@ holding area).  Correlation can't be made with any degree of certainty if related to vaccine. Felt burning sensation in arm after receiving vaccine and then pain on right side right under armpit (stabbing sensation).  Every time took a breath in, felt pain.  Patient reported having a hard  time walking.  Wasn't given any medication in EC. Pain was manageable after 5 hours.
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Blepharospasm, COVID-19, Chills, Cough, Diarrhoea
Clinical narrative: CONFIRMED COVID-19 INFECTION; THOUGHT WAS GOING TO DIE; SWOLLEN LEFT EYE; TWITCHING; This spontaneous report received from a patient concerned a 58 year old female. The patient's height, and weight were not reported. The patient's concurrent conditions included asthma, high blood pressure, and non-smoker. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported and batch number: 1802070 expiry: UNKNOWN) dose was not reported, administered on 17-MAR-2021 on left arm for prophylactic vaccination. No concomitant medications were reported. On 17-MAR-2021, the subject experienced swollen left eye. On 17-MAR-2021, the subject experienced twitching. On 18-MAR-2021, the subject experienced thought was going to die. On 19-MAR-2021, Laboratory data included: Body temperature (NR: not provided) 102 F. On 20-MAR-2021, the subject experienced confirmed covid-19 infection. Laboratory data included: COVID-19 PCR test (NR: not provided) Positive for COVID, and COVID-19 antigen test (NR: not provided) Positive for Covid. Treatment medications (dates unspecified) included: fexofenadine hydrochloride/pseudoephedrine hydrochloride, zinc, ascorbic acid, and ergocalciferol. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from swollen left eye, and twitching on 18-MAR-2021, had not recovered from confirmed covid-19 infection, and the outcome of thought was going to die was not reported. This report was non-serious.; Sender's Comments: V0: Medical assessment comment not required as per standard procedure as case assessed as non-serious.
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Fatigue, Headache, Pain, Pyrexia, SARS-CoV-2 test positive
Clinical narrative: CONFIRMED COVID-19 INFECTION; THOUGHT WAS GOING TO DIE; SWOLLEN LEFT EYE; TWITCHING; This spontaneous report received from a patient concerned a 58 year old female. The patient's height, and weight were not reported. The patient's concurrent conditions included asthma, high blood pressure, and non-smoker. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported and batch number: 1802070 expiry: UNKNOWN) dose was not reported, administered on 17-MAR-2021 on left arm for prophylactic vaccination. No concomitant medications were reported. On 17-MAR-2021, the subject experienced swollen left eye. On 17-MAR-2021, the subject experienced twitching. On 18-MAR-2021, the subject experienced thought was going to die. On 19-MAR-2021, Laboratory data included: Body temperature (NR: not provided) 102 F. On 20-MAR-2021, the subject experienced confirmed covid-19 infection. Laboratory data included: COVID-19 PCR test (NR: not provided) Positive for COVID, and COVID-19 antigen test (NR: not provided) Positive for Covid. Treatment medications (dates unspecified) included: fexofenadine hydrochloride/pseudoephedrine hydrochloride, zinc, ascorbic acid, and ergocalciferol. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from swollen left eye, and twitching on 18-MAR-2021, had not recovered from confirmed covid-19 infection, and the outcome of thought was going to die was not reported. This report was non-serious.; Sender's Comments: V0: Medical assessment comment not required as per standard procedure as case assessed as non-serious.
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Swelling of eyelid
Clinical narrative: CONFIRMED COVID-19 INFECTION; THOUGHT WAS GOING TO DIE; SWOLLEN LEFT EYE; TWITCHING; This spontaneous report received from a patient concerned a 58 year old female. The patient's height, and weight were not reported. The patient's concurrent conditions included asthma, high blood pressure, and non-smoker. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported and batch number: 1802070 expiry: UNKNOWN) dose was not reported, administered on 17-MAR-2021 on left arm for prophylactic vaccination. No concomitant medications were reported. On 17-MAR-2021, the subject experienced swollen left eye. On 17-MAR-2021, the subject experienced twitching. On 18-MAR-2021, the subject experienced thought was going to die. On 19-MAR-2021, Laboratory data included: Body temperature (NR: not provided) 102 F. On 20-MAR-2021, the subject experienced confirmed covid-19 infection. Laboratory data included: COVID-19 PCR test (NR: not provided) Positive for COVID, and COVID-19 antigen test (NR: not provided) Positive for Covid. Treatment medications (dates unspecified) included: fexofenadine hydrochloride/pseudoephedrine hydrochloride, zinc, ascorbic acid, and ergocalciferol. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from swollen left eye, and twitching on 18-MAR-2021, had not recovered from confirmed covid-19 infection, and the outcome of thought was going to die was not reported. This report was non-serious.; Sender's Comments: V0: Medical assessment comment not required as per standard procedure as case assessed as non-serious.
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Body temperature, COVID-19, Eye swelling, Feeling abnormal, Muscle twitching
Clinical narrative: CONFIRMED COVID-19 INFECTION; THOUGHT WAS GOING TO DIE; SWOLLEN LEFT EYE; TWITCHING; This spontaneous report received from a patient concerned a 58 year old female. The patient's height, and weight were not reported. The patient's concurrent conditions included asthma, high blood pressure, and non-smoker. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported and batch number: 1802070 expiry: UNKNOWN) dose was not reported, administered on 17-MAR-2021 on left arm for prophylactic vaccination. No concomitant medications were reported. On 17-MAR-2021, the subject experienced swollen left eye. On 17-MAR-2021, the subject experienced twitching. On 18-MAR-2021, the subject experienced thought was going to die. On 19-MAR-2021, Laboratory data included: Body temperature (NR: not provided) 102 F. On 20-MAR-2021, the subject experienced confirmed covid-19 infection. Laboratory data included: COVID-19 PCR test (NR: not provided) Positive for COVID, and COVID-19 antigen test (NR: not provided) Positive for Covid. Treatment medications (dates unspecified) included: fexofenadine hydrochloride/pseudoephedrine hydrochloride, zinc, ascorbic acid, and ergocalciferol. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from swollen left eye, and twitching on 18-MAR-2021, had not recovered from confirmed covid-19 infection, and the outcome of thought was going to die was not reported. This report was non-serious.; Sender's Comments: V0: Medical assessment comment not required as per standard procedure as case assessed as non-serious.
Sex: F
Vaccine: COVID19, COVID19
Symptoms: SARS-CoV-2 test
Clinical narrative: CONFIRMED COVID-19 INFECTION; THOUGHT WAS GOING TO DIE; SWOLLEN LEFT EYE; TWITCHING; This spontaneous report received from a patient concerned a 58 year old female. The patient's height, and weight were not reported. The patient's concurrent conditions included asthma, high blood pressure, and non-smoker. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported and batch number: 1802070 expiry: UNKNOWN) dose was not reported, administered on 17-MAR-2021 on left arm for prophylactic vaccination. No concomitant medications were reported. On 17-MAR-2021, the subject experienced swollen left eye. On 17-MAR-2021, the subject experienced twitching. On 18-MAR-2021, the subject experienced thought was going to die. On 19-MAR-2021, Laboratory data included: Body temperature (NR: not provided) 102 F. On 20-MAR-2021, the subject experienced confirmed covid-19 infection. Laboratory data included: COVID-19 PCR test (NR: not provided) Positive for COVID, and COVID-19 antigen test (NR: not provided) Positive for Covid. Treatment medications (dates unspecified) included: fexofenadine hydrochloride/pseudoephedrine hydrochloride, zinc, ascorbic acid, and ergocalciferol. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from swollen left eye, and twitching on 18-MAR-2021, had not recovered from confirmed covid-19 infection, and the outcome of thought was going to die was not reported. This report was non-serious.; Sender's Comments: V0: Medical assessment comment not required as per standard procedure as case assessed as non-serious.
Age: 62.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Blood pressure systolic decreased, Hyperhidrosis, Hypopnoea, Urticaria
Clinical narrative: About 10 minutes after I received the shot I was sitting in a chair and I started getting very hot, sweaty, and found like I was going to throw up.  Started seeing stars, vision narrowing.  I laid down on the floor, and it seemed like I was having a hard time breathing.  The pharmacist came out and started talking to me. My wife happened to be there and was trying to calm me down.  I felt like I was passing out.  The pharmacist checked my BP and it was like 80 something.  He felt I was having an allergic reaction so gave me a show with an Eppy pen.  They called paramedics.  I started feeling better but paramedics said I should still go to ER so ambulance took me to ER.  They ran blood tests, EKG, and chest Xray.  After a few hours they released me.  They basically said that it was ok for me to get second shot, but obviously I am now extremely concerned out about getting it
Age: 62.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Blood test, Chest X-ray, Dizziness, Dyspnoea, Electrocardiogram
Clinical narrative: About 10 minutes after I received the shot I was sitting in a chair and I started getting very hot, sweaty, and found like I was going to throw up.  Started seeing stars, vision narrowing.  I laid down on the floor, and it seemed like I was having a hard time breathing.  The pharmacist came out and started talking to me. My wife happened to be there and was trying to calm me down.  I felt like I was passing out.  The pharmacist checked my BP and it was like 80 something.  He felt I was having an allergic reaction so gave me a show with an Eppy pen.  They called paramedics.  I started feeling better but paramedics said I should still go to ER so ambulance took me to ER.  They ran blood tests, EKG, and chest Xray.  After a few hours they released me.  They basically said that it was ok for me to get second shot, but obviously I am now extremely concerned out about getting it
Age: 62.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Feeling hot, Hyperhidrosis, Nausea, Tunnel vision, Visual impairment
Clinical narrative: About 10 minutes after I received the shot I was sitting in a chair and I started getting very hot, sweaty, and found like I was going to throw up.  Started seeing stars, vision narrowing.  I laid down on the floor, and it seemed like I was having a hard time breathing.  The pharmacist came out and started talking to me. My wife happened to be there and was trying to calm me down.  I felt like I was passing out.  The pharmacist checked my BP and it was like 80 something.  He felt I was having an allergic reaction so gave me a show with an Eppy pen.  They called paramedics.  I started feeling better but paramedics said I should still go to ER so ambulance took me to ER.  They ran blood tests, EKG, and chest Xray.  After a few hours they released me.  They basically said that it was ok for me to get second shot, but obviously I am now extremely concerned out about getting it
Age: 62.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Ear discomfort, Tinnitus
Clinical narrative: Had the Moderna vaccine 4-7 days later experienced Tinnitus. Feels a little pressure and occasionally when popped ears felt like had temporary relief of the pressure and tinnitus. Warm compress and pressure with fingers massaging at base of skull and gave relief until fall asleep. Both the tinnitus and the pressure seemed to improve with the heat and pressure,  It is constant and does not seem to be drowned out by other sounds. Hearing is good.  Tried IBU for a week and did not help much. Was taking 4 doses/day and no improvement, one incidence of standing at the counter and seemed like floor moved. It passed quickly. Other than this no other vertigo or lightheadenes.
Age: 34.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Burning sensation, Injection site erythema, Injection site pruritus
Clinical narrative: Pt was diagnosed with Bell's Palsy on 4/4/21. Pharmacy was notified 4/5/21. Treatment is oral prednisone and acyclovir.
Age: 34.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Bell's palsy
Clinical narrative: Pt was diagnosed with Bell's Palsy on 4/4/21. Pharmacy was notified 4/5/21. Treatment is oral prednisone and acyclovir.
Age: 49.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Herpes virus infection
Clinical narrative: HERPES OUTBREAK; This spontaneous report received from a patient concerned a 49 year old female. The patient's height, and weight were not reported. The patient's concurrent conditions included non alcoholic, non smoker, and herpes, and other pre-existing medical conditions included no known allergies. no drug abuse illicit drug use. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 1805020 expiry: UNKNOWN) dose was not reported, administered to left arm on 21-MAR-2021 for prophylactic vaccination. No concomitant medications were reported. On 21-MAR-2021, the subject experienced herpes outbreak. Treatment medications (dates unspecified) included: valaciclovir hydrochloride. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient was recovering from herpes outbreak. This report was non-serious.; Sender's Comments: V0: medical assessment comment not required as per standard procedure as the case is assessed as non serious
Age: 20.0
Sex: M
Vaccine: COVID19, COVID19, COVID19
Symptoms: Blood test, Catheterisation cardiac normal, Chest pain, Computerised tomogram abnormal, Echocardiogram abnormal
Clinical narrative: Patient developed chest pain and shortness of breath 24 hours after receiving the 2nd dose of the Moderna vaccine. He was hospitalized for myocarditis and discharged in stable condition on 03Apr.
Age: 20.0
Sex: M
Vaccine: COVID19, COVID19, COVID19
Symptoms: Electrocardiogram ST segment depression, Electrocardiogram ST segment elevation, Myocarditis, Pericarditis, Troponin increased
Clinical narrative: Patient developed chest pain and shortness of breath 24 hours after receiving the 2nd dose of the Moderna vaccine. He was hospitalized for myocarditis and discharged in stable condition on 03Apr.
Age: 20.0
Sex: M
Vaccine: COVID19, COVID19, COVID19
Symptoms: Catheterisation cardiac, Electrocardiogram change, Myocarditis, Troponin increased
Clinical narrative: Patient developed chest pain and shortness of breath 24 hours after receiving the 2nd dose of the Moderna vaccine. He was hospitalized for myocarditis and discharged in stable condition on 03Apr.
Age: 20.0
Sex: M
Vaccine: COVID19, COVID19, COVID19
Symptoms: Chest pain, Dyspnoea, Electrocardiogram ST segment depression, Electrocardiogram ST segment elevation, Myocarditis
Clinical narrative: Patient developed chest pain and shortness of breath 24 hours after receiving the 2nd dose of the Moderna vaccine. He was hospitalized for myocarditis and discharged in stable condition on 03Apr.
Age: 20.0
Sex: M
Vaccine: COVID19, COVID19, COVID19
Symptoms: Troponin I increased
Clinical narrative: Patient developed chest pain and shortness of breath 24 hours after receiving the 2nd dose of the Moderna vaccine. He was hospitalized for myocarditis and discharged in stable condition on 03Apr.
Age: 59.0
Sex: F
Vaccine: COVID19, COVID19, COVID19, COVID19
Symptoms: Dyspnoea, Intensive care, Swollen tongue
Clinical narrative: Received vaccine at 14:30 and started feeling itching on her tongue. Took Bendaryl 50mg @ 15:15. Facial swelling, SOB, and difficulty swallowing upon arrival. Received Solu-Medrol, Benadryl, and Pepcid. Epinephrine 0.3mg Twinject IM x 4. Admitted to ICU.
Age: 59.0
Sex: F
Vaccine: COVID19, COVID19, COVID19, COVID19
Symptoms: Dysphagia, Dyspnoea, Intensive care, Swelling face, Tongue pruritus
Clinical narrative: Received vaccine at 14:30 and started feeling itching on her tongue. Took Bendaryl 50mg @ 15:15. Facial swelling, SOB, and difficulty swallowing upon arrival. Received Solu-Medrol, Benadryl, and Pepcid. Epinephrine 0.3mg Twinject IM x 4. Admitted to ICU.
Age: 59.0
Sex: F
Vaccine: COVID19, COVID19, COVID19, COVID19
Symptoms: Dyspnoea, Paraesthesia oral, Tachycardia, Throat tightness
Clinical narrative: Received vaccine at 14:30 and started feeling itching on her tongue. Took Bendaryl 50mg @ 15:15. Facial swelling, SOB, and difficulty swallowing upon arrival. Received Solu-Medrol, Benadryl, and Pepcid. Epinephrine 0.3mg Twinject IM x 4. Admitted to ICU.
Age: 59.0
Sex: F
Vaccine: COVID19, COVID19, COVID19, COVID19
Symptoms: Anaphylactic reaction, Dyspnoea
Clinical narrative: Received vaccine at 14:30 and started feeling itching on her tongue. Took Bendaryl 50mg @ 15:15. Facial swelling, SOB, and difficulty swallowing upon arrival. Received Solu-Medrol, Benadryl, and Pepcid. Epinephrine 0.3mg Twinject IM x 4. Admitted to ICU.