chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Injection site hypoaesthesia, Musculoskeletal disorder, Pain in extremity, Paraesthesia, Sensory loss
Clinical narrative: LOST ALL FEELING FROM THE UNDER ARM DOWN TO FINGERS; LOST THE ABILITY TO BUTTON USING THE LEFT ARM; ARM HAS GOTTEN WORSE; LEFT ARM (INJECTION SITE) WAS NUMB; ENTIRE ARM WAS TINGLING; This spontaneous report received from a patient concerned a male of unspecified age. The patient's height, and weight were not reported. No past medical history or concurrent conditions were reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: Unknown) dose was not reported, administered on 12-APR-2021 for prophylactic vaccination. The batch number was not reported and has been requested. No concomitant medications were reported. On 12-APR-2021, the patient experienced left arm (injection site) was numb. On 12-APR-2021, the patient experienced entire arm was tingling. On an unspecified date, the patient experienced lost all feeling from the under arm down to fingers, lost the ability to button using the left arm, and arm has gotten worse. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from arm has gotten worse, lost all feeling from the under arm down to fingers, and lost the ability to button using the left arm, and the outcome of left arm (injection site) was numb and entire arm was tingling was not reported. This report was non-serious.
Age: 41.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Abdominal pain, Arthralgia, Chills, Diarrhoea, Dizziness
Clinical narrative: BLURRY VISION; SHORTNESS OF BREATH (CAN NOT BREATH); CHEST PAIN/HURTS/BURNS (PROGRESSIVELY WORSE); KIDNEYS HOT AND SORE; CLOUDY URINE; FEEL LIKE GOING TO BLACK OUT (SIT DOWN BEFORE ACTUALLY BLACK OUT); TREMORS/SHAKING/COULD NOT STAND UP; FELT VERY SICK; CHILLS; NAUSEA; FEVER; CONSISTENT HEADACHE; MUSCLE ACHES AND PAINS; This spontaneous report received from a patient concerned a 41 year old male. The patient's height, and weight were not reported. The patient's pre-existing medical conditions included: The patient never been sick in life ever and had no sickness, no meds, no vaccine. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 1822811, and expiry: 20-MAR-2022) dose was not reported, administered on 25-OCT-2021 for prophylactic vaccination. No concomitant medications were reported. On 25-OCT-2021, the patient experienced tremors/shaking/could not stand up. On 25-OCT-2021, the patient experienced felt very sick. On 25-OCT-2021, the patient experienced chills. On 25-OCT-2021, the patient experienced nausea. On 25-OCT-2021, the patient experienced fever. On 25-OCT-2021, the patient experienced consistent headache. On 25-OCT-2021, the patient experienced muscle aches and pains. On NOV-2021, the patient experienced feel like going to black out (sit down before actually black out). On 22-NOV-2021, the patient experienced kidneys hot and sore. On 22-NOV-2021, the patient experienced cloudy urine. On 29-NOV-2021, the patient experienced chest pain/hurts/burns (progressively worse). On an unspecified date, the patient experienced shortness of breath (can not breath), and blurry vision. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from tremors/shaking/could not stand up, and chills, kidneys hot and sore, and cloudy urine on 26-NOV-2021, and fever on 12-NOV-2021, had not recovered from consistent headache, muscle aches and pains, nausea, feel like going to black out (sit down before actually black out), shortness of breath (can not breath), blurry vision, and chest pain/hurts/burns (progressively worse), and the outcome of felt very sick was not reported. This report was non-serious.
Age: 41.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Headache, Insomnia, Myalgia, Nausea, Pyrexia
Clinical narrative: BLURRY VISION; SHORTNESS OF BREATH (CAN NOT BREATH); CHEST PAIN/HURTS/BURNS (PROGRESSIVELY WORSE); KIDNEYS HOT AND SORE; CLOUDY URINE; FEEL LIKE GOING TO BLACK OUT (SIT DOWN BEFORE ACTUALLY BLACK OUT); TREMORS/SHAKING/COULD NOT STAND UP; FELT VERY SICK; CHILLS; NAUSEA; FEVER; CONSISTENT HEADACHE; MUSCLE ACHES AND PAINS; This spontaneous report received from a patient concerned a 41 year old male. The patient's height, and weight were not reported. The patient's pre-existing medical conditions included: The patient never been sick in life ever and had no sickness, no meds, no vaccine. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 1822811, and expiry: 20-MAR-2022) dose was not reported, administered on 25-OCT-2021 for prophylactic vaccination. No concomitant medications were reported. On 25-OCT-2021, the patient experienced tremors/shaking/could not stand up. On 25-OCT-2021, the patient experienced felt very sick. On 25-OCT-2021, the patient experienced chills. On 25-OCT-2021, the patient experienced nausea. On 25-OCT-2021, the patient experienced fever. On 25-OCT-2021, the patient experienced consistent headache. On 25-OCT-2021, the patient experienced muscle aches and pains. On NOV-2021, the patient experienced feel like going to black out (sit down before actually black out). On 22-NOV-2021, the patient experienced kidneys hot and sore. On 22-NOV-2021, the patient experienced cloudy urine. On 29-NOV-2021, the patient experienced chest pain/hurts/burns (progressively worse). On an unspecified date, the patient experienced shortness of breath (can not breath), and blurry vision. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from tremors/shaking/could not stand up, and chills, kidneys hot and sore, and cloudy urine on 26-NOV-2021, and fever on 12-NOV-2021, had not recovered from consistent headache, muscle aches and pains, nausea, feel like going to black out (sit down before actually black out), shortness of breath (can not breath), blurry vision, and chest pain/hurts/burns (progressively worse), and the outcome of felt very sick was not reported. This report was non-serious.
Age: 41.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Renal pain, Tremor, Vision blurred
Clinical narrative: BLURRY VISION; SHORTNESS OF BREATH (CAN NOT BREATH); CHEST PAIN/HURTS/BURNS (PROGRESSIVELY WORSE); KIDNEYS HOT AND SORE; CLOUDY URINE; FEEL LIKE GOING TO BLACK OUT (SIT DOWN BEFORE ACTUALLY BLACK OUT); TREMORS/SHAKING/COULD NOT STAND UP; FELT VERY SICK; CHILLS; NAUSEA; FEVER; CONSISTENT HEADACHE; MUSCLE ACHES AND PAINS; This spontaneous report received from a patient concerned a 41 year old male. The patient's height, and weight were not reported. The patient's pre-existing medical conditions included: The patient never been sick in life ever and had no sickness, no meds, no vaccine. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 1822811, and expiry: 20-MAR-2022) dose was not reported, administered on 25-OCT-2021 for prophylactic vaccination. No concomitant medications were reported. On 25-OCT-2021, the patient experienced tremors/shaking/could not stand up. On 25-OCT-2021, the patient experienced felt very sick. On 25-OCT-2021, the patient experienced chills. On 25-OCT-2021, the patient experienced nausea. On 25-OCT-2021, the patient experienced fever. On 25-OCT-2021, the patient experienced consistent headache. On 25-OCT-2021, the patient experienced muscle aches and pains. On NOV-2021, the patient experienced feel like going to black out (sit down before actually black out). On 22-NOV-2021, the patient experienced kidneys hot and sore. On 22-NOV-2021, the patient experienced cloudy urine. On 29-NOV-2021, the patient experienced chest pain/hurts/burns (progressively worse). On an unspecified date, the patient experienced shortness of breath (can not breath), and blurry vision. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from tremors/shaking/could not stand up, and chills, kidneys hot and sore, and cloudy urine on 26-NOV-2021, and fever on 12-NOV-2021, had not recovered from consistent headache, muscle aches and pains, nausea, feel like going to black out (sit down before actually black out), shortness of breath (can not breath), blurry vision, and chest pain/hurts/burns (progressively worse), and the outcome of felt very sick was not reported. This report was non-serious.
Age: 41.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Chest pain, Chills, Dizziness, Dyspnoea, Headache
Clinical narrative: BLURRY VISION; SHORTNESS OF BREATH (CAN NOT BREATH); CHEST PAIN/HURTS/BURNS (PROGRESSIVELY WORSE); KIDNEYS HOT AND SORE; CLOUDY URINE; FEEL LIKE GOING TO BLACK OUT (SIT DOWN BEFORE ACTUALLY BLACK OUT); TREMORS/SHAKING/COULD NOT STAND UP; FELT VERY SICK; CHILLS; NAUSEA; FEVER; CONSISTENT HEADACHE; MUSCLE ACHES AND PAINS; This spontaneous report received from a patient concerned a 41 year old male. The patient's height, and weight were not reported. The patient's pre-existing medical conditions included: The patient never been sick in life ever and had no sickness, no meds, no vaccine. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 1822811, and expiry: 20-MAR-2022) dose was not reported, administered on 25-OCT-2021 for prophylactic vaccination. No concomitant medications were reported. On 25-OCT-2021, the patient experienced tremors/shaking/could not stand up. On 25-OCT-2021, the patient experienced felt very sick. On 25-OCT-2021, the patient experienced chills. On 25-OCT-2021, the patient experienced nausea. On 25-OCT-2021, the patient experienced fever. On 25-OCT-2021, the patient experienced consistent headache. On 25-OCT-2021, the patient experienced muscle aches and pains. On NOV-2021, the patient experienced feel like going to black out (sit down before actually black out). On 22-NOV-2021, the patient experienced kidneys hot and sore. On 22-NOV-2021, the patient experienced cloudy urine. On 29-NOV-2021, the patient experienced chest pain/hurts/burns (progressively worse). On an unspecified date, the patient experienced shortness of breath (can not breath), and blurry vision. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from tremors/shaking/could not stand up, and chills, kidneys hot and sore, and cloudy urine on 26-NOV-2021, and fever on 12-NOV-2021, had not recovered from consistent headache, muscle aches and pains, nausea, feel like going to black out (sit down before actually black out), shortness of breath (can not breath), blurry vision, and chest pain/hurts/burns (progressively worse), and the outcome of felt very sick was not reported. This report was non-serious.
Age: 41.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Malaise, Myalgia, Nausea, Pyrexia, Renal pain
Clinical narrative: BLURRY VISION; SHORTNESS OF BREATH (CAN NOT BREATH); CHEST PAIN/HURTS/BURNS (PROGRESSIVELY WORSE); KIDNEYS HOT AND SORE; CLOUDY URINE; FEEL LIKE GOING TO BLACK OUT (SIT DOWN BEFORE ACTUALLY BLACK OUT); TREMORS/SHAKING/COULD NOT STAND UP; FELT VERY SICK; CHILLS; NAUSEA; FEVER; CONSISTENT HEADACHE; MUSCLE ACHES AND PAINS; This spontaneous report received from a patient concerned a 41 year old male. The patient's height, and weight were not reported. The patient's pre-existing medical conditions included: The patient never been sick in life ever and had no sickness, no meds, no vaccine. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 1822811, and expiry: 20-MAR-2022) dose was not reported, administered on 25-OCT-2021 for prophylactic vaccination. No concomitant medications were reported. On 25-OCT-2021, the patient experienced tremors/shaking/could not stand up. On 25-OCT-2021, the patient experienced felt very sick. On 25-OCT-2021, the patient experienced chills. On 25-OCT-2021, the patient experienced nausea. On 25-OCT-2021, the patient experienced fever. On 25-OCT-2021, the patient experienced consistent headache. On 25-OCT-2021, the patient experienced muscle aches and pains. On NOV-2021, the patient experienced feel like going to black out (sit down before actually black out). On 22-NOV-2021, the patient experienced kidneys hot and sore. On 22-NOV-2021, the patient experienced cloudy urine. On 29-NOV-2021, the patient experienced chest pain/hurts/burns (progressively worse). On an unspecified date, the patient experienced shortness of breath (can not breath), and blurry vision. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from tremors/shaking/could not stand up, and chills, kidneys hot and sore, and cloudy urine on 26-NOV-2021, and fever on 12-NOV-2021, had not recovered from consistent headache, muscle aches and pains, nausea, feel like going to black out (sit down before actually black out), shortness of breath (can not breath), blurry vision, and chest pain/hurts/burns (progressively worse), and the outcome of felt very sick was not reported. This report was non-serious.
Age: 41.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Tremor, Urine abnormality, Vision blurred
Clinical narrative: BLURRY VISION; SHORTNESS OF BREATH (CAN NOT BREATH); CHEST PAIN/HURTS/BURNS (PROGRESSIVELY WORSE); KIDNEYS HOT AND SORE; CLOUDY URINE; FEEL LIKE GOING TO BLACK OUT (SIT DOWN BEFORE ACTUALLY BLACK OUT); TREMORS/SHAKING/COULD NOT STAND UP; FELT VERY SICK; CHILLS; NAUSEA; FEVER; CONSISTENT HEADACHE; MUSCLE ACHES AND PAINS; This spontaneous report received from a patient concerned a 41 year old male. The patient's height, and weight were not reported. The patient's pre-existing medical conditions included: The patient never been sick in life ever and had no sickness, no meds, no vaccine. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 1822811, and expiry: 20-MAR-2022) dose was not reported, administered on 25-OCT-2021 for prophylactic vaccination. No concomitant medications were reported. On 25-OCT-2021, the patient experienced tremors/shaking/could not stand up. On 25-OCT-2021, the patient experienced felt very sick. On 25-OCT-2021, the patient experienced chills. On 25-OCT-2021, the patient experienced nausea. On 25-OCT-2021, the patient experienced fever. On 25-OCT-2021, the patient experienced consistent headache. On 25-OCT-2021, the patient experienced muscle aches and pains. On NOV-2021, the patient experienced feel like going to black out (sit down before actually black out). On 22-NOV-2021, the patient experienced kidneys hot and sore. On 22-NOV-2021, the patient experienced cloudy urine. On 29-NOV-2021, the patient experienced chest pain/hurts/burns (progressively worse). On an unspecified date, the patient experienced shortness of breath (can not breath), and blurry vision. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from tremors/shaking/could not stand up, and chills, kidneys hot and sore, and cloudy urine on 26-NOV-2021, and fever on 12-NOV-2021, had not recovered from consistent headache, muscle aches and pains, nausea, feel like going to black out (sit down before actually black out), shortness of breath (can not breath), blurry vision, and chest pain/hurts/burns (progressively worse), and the outcome of felt very sick was not reported. This report was non-serious.
Age: 10.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Chest pain, Laboratory test, Myocarditis
Clinical narrative: Patient received 2nd dose Pfizer COVID vaccine on 11/28. He developed vomiting and chest pain 12 hours later. The following day, he additionally had dizziness with activity. Symptoms progressed over 3 days following vaccination. He was evaluated in urgent care on 11/30, then the emergency room on 12/1. He was found to have elevated troponin and exam concerning for myocarditis and was admitted to the hospital. He was noted to have rising troponin until the evening of 12/1, then started downtrending, was observed in hospitalized setting until 12/3. His symptoms also resolved during hospitalization.
Age: 10.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Chest pain, Dizziness exertional, Echocardiogram, Electrocardiogram, Magnetic resonance imaging heart
Clinical narrative: Patient received 2nd dose Pfizer COVID vaccine on 11/28. He developed vomiting and chest pain 12 hours later. The following day, he additionally had dizziness with activity. Symptoms progressed over 3 days following vaccination. He was evaluated in urgent care on 11/30, then the emergency room on 12/1. He was found to have elevated troponin and exam concerning for myocarditis and was admitted to the hospital. He was noted to have rising troponin until the evening of 12/1, then started downtrending, was observed in hospitalized setting until 12/3. His symptoms also resolved during hospitalization.
Age: 10.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Troponin increased, Vomiting
Clinical narrative: Patient received 2nd dose Pfizer COVID vaccine on 11/28. He developed vomiting and chest pain 12 hours later. The following day, he additionally had dizziness with activity. Symptoms progressed over 3 days following vaccination. He was evaluated in urgent care on 11/30, then the emergency room on 12/1. He was found to have elevated troponin and exam concerning for myocarditis and was admitted to the hospital. He was noted to have rising troponin until the evening of 12/1, then started downtrending, was observed in hospitalized setting until 12/3. His symptoms also resolved during hospitalization.
Age: 10.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Incorrect dose administered
Clinical narrative: no adverse reaction
Age: 10.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: No adverse event
Clinical narrative: no adverse reaction
Age: 37.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Arthralgia, Bursitis, Injection site pain, Insomnia, Joint range of motion decreased
Clinical narrative: Patient describes limited mobility in arm, severe shoulder and arm pain
Age: 37.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Mobility decreased, Neuritis, Pain, Pain in extremity
Clinical narrative: Patient describes limited mobility in arm, severe shoulder and arm pain
Age: 37.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Arthralgia, Mobility decreased, Pain in extremity
Clinical narrative: Patient describes limited mobility in arm, severe shoulder and arm pain
Age: 40.0
Sex: M
Vaccine: COVID19
Symptoms: Burning sensation, Chills, Dyspepsia, Pain, Pyrexia
Clinical narrative: Burning around my heart; Burning inside and around his kidneys/burning; It totally wiped him out; he napped for two hours; Pain; Felt like he had a fever at some point; Chills; This spontaneous case was reported by a consumer and describes the occurrence of DYSPEPSIA (Burning around my heart), BURNING SENSATION (Burning inside and around his kidneys/burning), SOMNOLENCE (It totally wiped him out; he napped for two hours), PAIN (Pain) and PYREXIA (Felt like he had a fever at some point) in a 41-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 26-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 20-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 18-Nov-2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. In November 2021, the patient experienced SOMNOLENCE (It totally wiped him out; he napped for two hours), PAIN (Pain), PYREXIA (Felt like he had a fever at some point) and CHILLS (Chills). On 18-Nov-2021,  after starting mRNA-1273 (Moderna COVID-19 Vaccine), the patient experienced DYSPEPSIA (Burning around my heart) and BURNING SENSATION (Burning inside and around his kidneys/burning). On 21-Nov-2021, DYSPEPSIA (Burning around my heart), BURNING SENSATION (Burning inside and around his kidneys/burning), SOMNOLENCE (It totally wiped him out; he napped for two hours), PAIN (Pain), PYREXIA (Felt like he had a fever at some point) and CHILLS (Chills) had resolved.            Concomitant medications was not reported.  Treatment medications was not reported. The symptoms went away 3 days after the injection and patient was back to normal at the time of report.   Most recent FOLLOW-UP information incorporated above includes: On 25-Nov-2021: Follow-up information updates outcome of the events and narrative information
Age: 40.0
Sex: M
Vaccine: COVID19
Symptoms: Somnolence
Clinical narrative: Burning around my heart; Burning inside and around his kidneys/burning; It totally wiped him out; he napped for two hours; Pain; Felt like he had a fever at some point; Chills; This spontaneous case was reported by a consumer and describes the occurrence of DYSPEPSIA (Burning around my heart), BURNING SENSATION (Burning inside and around his kidneys/burning), SOMNOLENCE (It totally wiped him out; he napped for two hours), PAIN (Pain) and PYREXIA (Felt like he had a fever at some point) in a 41-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 26-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 20-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 18-Nov-2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. In November 2021, the patient experienced SOMNOLENCE (It totally wiped him out; he napped for two hours), PAIN (Pain), PYREXIA (Felt like he had a fever at some point) and CHILLS (Chills). On 18-Nov-2021,  after starting mRNA-1273 (Moderna COVID-19 Vaccine), the patient experienced DYSPEPSIA (Burning around my heart) and BURNING SENSATION (Burning inside and around his kidneys/burning). On 21-Nov-2021, DYSPEPSIA (Burning around my heart), BURNING SENSATION (Burning inside and around his kidneys/burning), SOMNOLENCE (It totally wiped him out; he napped for two hours), PAIN (Pain), PYREXIA (Felt like he had a fever at some point) and CHILLS (Chills) had resolved.            Concomitant medications was not reported.  Treatment medications was not reported. The symptoms went away 3 days after the injection and patient was back to normal at the time of report.   Most recent FOLLOW-UP information incorporated above includes: On 25-Nov-2021: Follow-up information updates outcome of the events and narrative information
Sex: U
Vaccine: COVID19
Symptoms: Erythema, Swelling
Clinical narrative: I continue to have readness 4x4 inch in armpit; swelling in armpit; Based on the current case data, this case has been classified as invalid. This spontaneous case was reported by an other health care professional and describes the occurrence of ERYTHEMA (i continue to have readness 4x4 inch in armpit) and SWELLING (swelling in armpit) in a  patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. No Medical History information was reported. In November 2021, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 24-Nov-2021, the patient experienced ERYTHEMA (i continue to have readness 4x4 inch in armpit) and SWELLING (swelling in armpit). The patient was treated with DIPHENHYDRAMINE HYDROCHLORIDE (BENADRYL [DIPHENHYDRAMINE HYDROCHLORIDE]) in November 2021 for Adverse event, at an unspecified dose and frequency. At the time of the report, ERYTHEMA (i continue to have readness 4x4 inch in armpit) and SWELLING (swelling in armpit) had not resolved. For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments. No concomitant medications were reported.
Age: 58.0
Sex: F
Vaccine: COVID19
Symptoms: Vaccination site erythema, Vaccination site pain, Vaccination site pruritus, Vaccination site swelling
Clinical narrative: This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE PAIN (sore at the site, seems to be getting worse and burning), VACCINATION SITE PRURITUS (This arm is itching me so bad), VACCINATION SITE ERYTHEMA (Area were injected is red/I have a red knot) and VACCINATION SITE SWELLING (Area were injected is slowen/I have a red knot) in a 58-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 065F218) for COVID-19 vaccination. No medical history was reported. Previously administered products included for Product used for unknown indication: PFIZER BIOTECH COVID-19 Vaccine (lot EN6190 (8) hard to read (right arm)) on 24-Feb-2021 and PFIZER BIOTECH COVID-19 Vaccine (lot EN6206 (right arm)) on 16-Mar-2021.Past adverse reactions to the above products included No adverse event with PFIZER BIOTECH COVID-19 Vaccine and PFIZER BIOTECH COVID-19 Vaccine.Concurrent medical conditions included Hypertension.Concomitant products included OXYMETAZOLINE HYDROCHLORIDE (CLARITIN ALLERGIC) for an unknown indication.On 23-Nov-2021, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. In November 2021, the patient experienced VACCINATION SITE PAIN (sore at the site, seems to be getting worse and burning). On 24-Nov-2021, the patient experienced VACCINATION SITE PRURITUS (This arm is itching me so bad), VACCINATION SITE ERYTHEMA (Area were injected is red/I have a red knot) and VACCINATION SITE SWELLING (Area were injected is slowen/I have a red knot). The patient was treated with DIPHENHYDRAMINE HYDROCHLORIDE (BENADRYL [DIPHENHYDRAMINE HYDROCHLORIDE]) for Adverse event, at an unspecified dose and frequency and IBUPROFEN for Adverse event, at an unspecified dose and frequency. At the time of the report, VACCINATION SITE PAIN (sore at the site, seems to be getting worse and burning), VACCINATION SITE PRURITUS (This arm is itching me so bad), VACCINATION SITE ERYTHEMA (Area were injected is red/I have a red knot) and VACCINATION SITE SWELLING (Area were injected is slowen/I have a red knot) outcome was unknown. For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.Patient took blood pressure medication as concomitant drug. It was reported that, itching was not normal. It wasn't this bad last night but it seems to be getting Worse and having a hard time with the injection site. Most recent FOLLOW-UP information incorporated above includes: On 24-Nov-2021: Follow up received contain additional information added for the events.
Age: 21.0
Sex: F
Vaccine: COVID19
Symptoms: Abdominal discomfort, Illness, Influenza like illness, Myalgia
Clinical narrative: This spontaneous case was reported by a consumer and describes the occurrence of INFLUENZA LIKE ILLNESS (Feel like very fluish), ABDOMINAL DISCOMFORT (Stomach's a bit upset), ILLNESS (Feeling so sick) and MYALGIA (All over body aches/pain in arm, neck, shoulder) in a 21-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 014H21A, 016C21A and 026B21A) for COVID-19 vaccination. No medical history was reported. Concomitant products included DEXTROMETHORPHAN HYDROBROMIDE (DELSYM) from 22-Nov-2021 to an unknown date for Cough, FLUOXETINE HYDROCHLORIDE (PROZAC), ETONOGESTREL (NEXPLANON), TILACTASE (LACTAID), COLESTIPOL and VITAMINS NOS for an unknown indication. On 05-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form.On 03-May-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form.On 23-Nov-2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 23-Nov-2021,  after starting mRNA-1273 (Moderna COVID-19 Vaccine), the patient experienced MYALGIA (All over body aches/pain in arm, neck, shoulder). On an unknown date, the patient experienced INFLUENZA LIKE ILLNESS (Feel like very fluish), ABDOMINAL DISCOMFORT (Stomach's a bit upset) and ILLNESS (Feeling so sick). The patient was treated with IBUPROFEN (ADVIL [IBUPROFEN]) for Adverse event, at an unspecified dose and frequency. At the time of the report, INFLUENZA LIKE ILLNESS (Feel like very fluish), ABDOMINAL DISCOMFORT (Stomach's a bit upset), ILLNESS (Feeling so sick) and MYALGIA (All over body aches/pain in arm, neck, shoulder) outcome was unknown. The concomitant medications included generic birth control pill and vitamins 1 per day. Patient just got the booster shot and  feel like very fluish. she thought it was half the normal dose and she didn't remember feeling so sick. Got booster at 11 am yesterday about 10pm last night started getting more pain in arm, neck, shoulder and woke up this morning and feel like have all over body aches. Stomach's a bit upset. Patient  took a COVID-19 test (no results) but did not think it's COVID-19.The patient, took a COVID-19 test with inconclusive result. This case was linked to MOD-2021-069680 (Patient Link).
Sex: F
Vaccine: COVID19
Symptoms: Cough, SARS-CoV-2 test
Clinical narrative: after the second dose she had a cough a few months  after that/nothing was wrong with her after the second dose, and then she developed the cough./states there's was never anything really wrong with her, just had this cough; This spontaneous case was reported by a consumer and describes the occurrence of COUGH (after the second dose she had a cough a few months  after that/nothing was wrong with her after the second dose, and then she developed the cough./states there's was never anything really wrong with her, just had this cough) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 021B21A and 010A21A) for COVID-19 vaccination.     No Medical History information was reported.   On 25-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 25-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient experienced COUGH (after the second dose she had a cough a few months  after that/nothing was wrong with her after the second dose, and then she developed the cough./states there's was never anything really wrong with her, just had this cough). At the time of the report, COUGH (after the second dose she had a cough a few months  after that/nothing was wrong with her after the second dose, and then she developed the cough./states there's was never anything really wrong with her, just had this cough) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, SARS-CoV-2 test: negative (Negative) Negative.         No Treatment information was provided. No concomitant medication was provided.   This case was linked to MOD-2021-395953, MOD-2021-396015 (Patient Link).   Reporter did not allow further contact
Age: 76.0
Sex: M
Vaccine: COVID19
Symptoms: Blood glucose, Blood glucose increased, Glycosylated haemoglobin, Glycosylated haemoglobin increased
Clinical narrative: sugar has gone very very high since he had the Moderna Covid-19 vaccine booster; A1C last month was 9; This spontaneous case was reported by a consumer and describes the occurrence of BLOOD GLUCOSE INCREASED (sugar has gone very very high since he had the Moderna Covid-19 vaccine booster) and GLYCOSYLATED HAEMOGLOBIN INCREASED (A1C last month was 9) in a 76-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 037C21A, 007B21A and 030A21A) for COVID-19 vaccination.     Concurrent medical conditions included Type 2 diabetes mellitus.   On 18-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 15-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 15-Sep-2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. In October 2021, the patient experienced GLYCOSYLATED HAEMOGLOBIN INCREASED (A1C last month was 9). On an unknown date, the patient experienced BLOOD GLUCOSE INCREASED (sugar has gone very very high since he had the Moderna Covid-19 vaccine booster). At the time of the report, BLOOD GLUCOSE INCREASED (sugar has gone very very high since he had the Moderna Covid-19 vaccine booster) and GLYCOSYLATED HAEMOGLOBIN INCREASED (A1C last month was 9) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): In 2021, Blood glucose: high (High) very very high. In October 2021, Glycosylated haemoglobin: 9 (High) A1C last month was 9.         Concomitant medication of the patient was not reported.   The patent reported that he followed a diet and will have a check up with his doctor on 26-Nov-2021. All 3 doses were given at a local hospital.
Age: 56.0
Sex: M
Vaccine: COVID19
Symptoms: Vaccination complication
Clinical narrative: This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION COMPLICATION (Reactions for this one seem to be very light) in a 56-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 039F21A) for an unknown indication.  Concomitant products included COLECALCIFEROL (VITAMIN D3), UBIDECARENONE (COQ-10), MAGNESIUM and VITAMIN C [ASCORBIC ACID] for an unknown indication.On 19-Nov-2021, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced VACCINATION COMPLICATION (Reactions for this one seem to be very light). At the time of the report, VACCINATION COMPLICATION (Reactions for this one seem to be very light) outcome was unknown. No treatment medications were reported. This case was linked to MOD-2021-396066 (Patient Link).
Sex: U
Vaccine: COVID19
Symptoms: Myalgia
Clinical narrative: Patients had body pain after they had the Moderna COVID-19 Vaccine; Based on the current case data, this case has been classified as invalid. This spontaneous case was reported by a consumer and describes the occurrence of MYALGIA (Patients had body pain after they had the Moderna COVID-19 Vaccine) in a  patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On an unknown date, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced MYALGIA (Patients had body pain after they had the Moderna COVID-19 Vaccine). At the time of the report, MYALGIA (Patients had body pain after they had the Moderna COVID-19 Vaccine) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No concomitant medications were reported.  No treatment details were provided.  The doctor had patients who had body pain after they had the Moderna Covid19 Vaccine, but never ever as bad as this.  The patient received booster dose.   This case was linked to MOD-2021-395953, MOD-2021-395984 (Patient Link).
Age: 41.0
Sex: F
Vaccine: COVID19
Symptoms: Discomfort, Lymphadenopathy, Mammogram
Clinical narrative: This spontaneous case was reported by a consumer and describes the occurrence of DISCOMFORT (armpit caused a lot of discomfort) and LYMPHADENOPATHY (developed auxiliary node in her armpits and armpit was swollen) in a 41-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 038A21A) for COVID-19 vaccination. No Medical History information was reported. On 18-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. In 2021, the patient experienced DISCOMFORT (armpit caused a lot of discomfort) and LYMPHADENOPATHY (developed auxiliary node in her armpits and armpit was swollen). The patient was treated with Surgery for Lymphadenopathy. On 09-Nov-2021, DISCOMFORT (armpit caused a lot of discomfort) had resolved and LYMPHADENOPATHY (developed auxiliary node in her armpits and armpit was swollen) outcome was unknown. DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, Mammogram: abnormal (abnormal) auxiliary node in her armpits it is not cancerous but it is benign. mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosing remained unchanged. The concomitant history was not reported. The treatment history was not provided. Patient had auxiliary node in her armpits surgically removed on the 9 Nov 2021. This case was linked to MOD-2021-396147 (Patient Link).
Age: 64.0
Sex: F
Vaccine: COVID19
Symptoms: Poor quality product administered, Product colour issue
Clinical narrative: This spontaneous case was reported by a consumer and describes the occurrence of POOR QUALITY PRODUCT ADMINISTERED (Received booster that looked brown) and PRODUCT COLOUR ISSUE (Received booster that looked brown) in a 67-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 026D21A) for COVID-19 vaccination. Concomitant products included MULTIVITAMIN [VITAMINS NOS] from 23-Nov-2021 to an unknown date for an unknown indication. On 23-Nov-2021, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) .25 milliliter. On 23-Nov-2021, the patient experienced POOR QUALITY PRODUCT ADMINISTERED (Received booster that looked brown) and PRODUCT COLOUR ISSUE (Received booster that looked brown). On 23-Nov-2021, POOR QUALITY PRODUCT ADMINISTERED (Received booster that looked brown) and PRODUCT COLOUR ISSUE (Received booster that looked brown) had resolved. Patient do not have any adverse event related to vaccine. Treatment information was not reported. Most recent FOLLOW-UP information incorporated above includes: On 26-Nov-2021: Follow-up received include reporter and patient details, information about product and concomitant medication and narrative updated.
Age: 77.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Pain in extremity
Clinical narrative: sore left arm for a few days; This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (sore left arm for a few days) in a 77-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 048A21A and 019A21A) for COVID-19 vaccination.     The patient's past medical history included Bypass surgery (quadruple bypass heart surgery,lost a lot of weight (57 lbs.) after the heart surgery) in April 2021. Concurrent medical conditions included Diabetes.   On 06-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 03-May-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On an unknown date, the patient experienced PAIN IN EXTREMITY (sore left arm for a few days). At the time of the report, PAIN IN EXTREMITY (sore left arm for a few days) had resolved.            The caller stated that he felt like superman after receiving first and second doses.  In Apr 2021, patient experienced pain throughout his body and went to hospital and had a quadruple bypass heart surgery. Patient reported that he is having occasional feeling of fainting since the heart surgery and lost a lot of weights(57 lbs.)  Concomitant medications included prescribed medications for heart and diabetics.  Patient did not have any known drug or food allergies.  Treatment details were not provided.   This case was linked to MOD-2021-395844, MOD-2021-396362 (Patient Link).
Age: 77.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Coronary artery bypass, Dizziness, Feeling abnormal, Pain, Vaccination site pain
Clinical narrative: sore left arm for a few days; This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (sore left arm for a few days) in a 77-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 048A21A and 019A21A) for COVID-19 vaccination.     The patient's past medical history included Bypass surgery (quadruple bypass heart surgery,lost a lot of weight (57 lbs.) after the heart surgery) in April 2021. Concurrent medical conditions included Diabetes.   On 06-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 03-May-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On an unknown date, the patient experienced PAIN IN EXTREMITY (sore left arm for a few days). At the time of the report, PAIN IN EXTREMITY (sore left arm for a few days) had resolved.            The caller stated that he felt like superman after receiving first and second doses.  In Apr 2021, patient experienced pain throughout his body and went to hospital and had a quadruple bypass heart surgery. Patient reported that he is having occasional feeling of fainting since the heart surgery and lost a lot of weights(57 lbs.)  Concomitant medications included prescribed medications for heart and diabetics.  Patient did not have any known drug or food allergies.  Treatment details were not provided.   This case was linked to MOD-2021-395844, MOD-2021-396362 (Patient Link).
Age: 77.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Weight decreased
Clinical narrative: sore left arm for a few days; This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (sore left arm for a few days) in a 77-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 048A21A and 019A21A) for COVID-19 vaccination.     The patient's past medical history included Bypass surgery (quadruple bypass heart surgery,lost a lot of weight (57 lbs.) after the heart surgery) in April 2021. Concurrent medical conditions included Diabetes.   On 06-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 03-May-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On an unknown date, the patient experienced PAIN IN EXTREMITY (sore left arm for a few days). At the time of the report, PAIN IN EXTREMITY (sore left arm for a few days) had resolved.            The caller stated that he felt like superman after receiving first and second doses.  In Apr 2021, patient experienced pain throughout his body and went to hospital and had a quadruple bypass heart surgery. Patient reported that he is having occasional feeling of fainting since the heart surgery and lost a lot of weights(57 lbs.)  Concomitant medications included prescribed medications for heart and diabetics.  Patient did not have any known drug or food allergies.  Treatment details were not provided.   This case was linked to MOD-2021-395844, MOD-2021-396362 (Patient Link).
Age: 79.0
Sex: F
Vaccine: COVID19
Symptoms: Asthenia, Mobility decreased
Clinical narrative: This spontaneous case was reported by a consumer and describes the occurrence of ASTHENIA (Quite weak) and MOBILITY DECREASED (Has difficulty getting up and moving around) in a 79-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. Concurrent medical conditions included Dementia. On 23-Nov-2021, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 23-Nov-2021, the patient experienced ASTHENIA (Quite weak) and MOBILITY DECREASED (Has difficulty getting up and moving around). At the time of the report, ASTHENIA (Quite weak) and MOBILITY DECREASED (Has difficulty getting up and moving around) was resolving. No concomitant medications were reported. No treatment information was provided. Most recent FOLLOW-UP information incorporated above includes: On 24-Nov-2021: Follow-up received on 24-Nov-2021, event outcome updated.
Age: 98.0
Sex: M
Vaccine: COVID19
Symptoms: Death
Clinical narrative: past away a few days after getting the Moderna first dose; This spontaneous case was reported by a physician and describes the occurrence of DEATH (past away a few days after getting the Moderna first dose) in a 98-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     Concurrent medical conditions included Leukemia.    On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. Death occurred on an unknown date The cause of death was not reported. It is unknown if an autopsy was performed.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   no treatment and concomitant medications reported. Company Comment: This case concerns a 98-year-old, male patient with relevant medical history of hypertension, atrial fibrillation, heart catherization, leukemia, who experienced the unexpected event of Death. The event occurred approximately few hours after the first dose of mRNA-1273 (Moderna covid-19 vaccine). The rechallenge was not applicable, as the event happened after the first dose. Though limited information provided such as circumstances surrounding death, cause of death, and autopsy precludes a complete medical and causal assessment of this case; however, this patient's advanced age and multiple underlying medical conditions remains a confounder. The benefit-risk relationship of mRNA-1273 (Moderna covid-19 vaccine) is not affected by this report.; Sender's Comments: This case concerns a 98-year-old, male patient with relevant medical history of hypertension, atrial fibrillation, heart catherization, leukemia, who experienced the unexpected event of Death. The event occurred approximately few hours after the first dose of mRNA-1273 (Moderna covid-19 vaccine). The rechallenge was not applicable, as the event happened after the first dose. Though limited information provided such as circumstances surrounding death, cause of death, and autopsy precludes a complete medical and causal assessment of this case; however, this patient's advanced age and multiple underlying medical conditions remains a confounder. The benefit-risk relationship of mRNA-1273 (Moderna covid-19 vaccine) is not affected by this report.; Reported Cause(s) of Death: Unknown cause of death