chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 59.0
Sex: M
Vaccine: COVID19
Symptoms: Herpes zoster, Musculoskeletal stiffness, Pain, Rash
Clinical narrative: Stiff neck/could not turn the neck around; Shingles; left part of body is sore; Rash on chest and back; This spontaneous case was reported by a consumer and describes the occurrence of MUSCULOSKELETAL STIFFNESS (Stiff neck/could not turn the neck around), HERPES ZOSTER (Shingles), PAIN (left part of body is sore) and RASH (Rash on chest and back) in a 59-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 042B21A and 036A21A) for COVID-19 vaccination.     No medical history was provided by the reporter.  Concomitant products included VALACICLOVIR and GABAPENTIN for an unknown indication.   On 15-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 12-Apr-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 MUSCULOSKELETAL STIFFNESS (Stiff neck/could not turn the neck around), HERPES ZOSTER (Shingles), PAIN (left part of body is sore) and RASH (Rash on chest and back). At the time of the report, MUSCULOSKELETAL STIFFNESS (Stiff neck/could not turn the neck around), HERPES ZOSTER (Shingles), PAIN (left part of body is sore) and RASH (Rash on chest and back) had not resolved.        Patient visited HCP and started taking prescribed medications. Patient was reported events are still ongoing. Patient said he was generally not allergic and has no other pre-existing conditions or side effects.
Age: 78.0
Sex: F
Vaccine: COVID19
Symptoms: Pyrexia
Clinical narrative: Fever; This spontaneous case was reported by an other health care professional and describes the occurrence of PYREXIA (Fever) in a 78-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 032L20A and 037K2019) for COVID-19 vaccination.     No Medical History information was reported.  Concomitant products included LISINOPRIL and VITAMINS NOS (DAILY VITAMINS) for an unknown indication.   On 08-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 05-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. In February 2021, the patient experienced PYREXIA (Fever). The patient was treated with PARACETAMOL (TYLENOL) for Fever, at an unspecified dose and frequency and IBUPROFEN (MOTRIN [IBUPROFEN]) for Fever, at an unspecified dose and frequency. In February 2021, PYREXIA (Fever) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   The other health care professional (speech therapist) stated that the fever lasted for around 24 hours.
Age: 33.0
Sex: F
Vaccine: COVID19
Symptoms: Arthritis, Body temperature, Body temperature abnormal, Cold urticaria, Dizziness
Clinical narrative: Sore arm; First Dose 27May2021/Second dose 20Aug2021; faint; temperature dropped to about 96 degrees; feeling of shock happening; dizzy; freezing rash around mouth; Spinal pain; sore arm; sweating; Arthritis; This spontaneous case was reported by a consumer and describes the occurrence of SYNCOPE (faint) in a 33-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 088D21A and 050C21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.   On 27-May-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 20-Aug-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 27-May-2021, the patient experienced ARTHRITIS (Arthritis). On 20-Aug-2021, the patient experienced SYNCOPE (faint) (seriousness criterion medically significant), BODY TEMPERATURE ABNORMAL (temperature dropped to about 96 degrees F), FEELING ABNORMAL (feeling of shock happening), DIZZINESS (dizzy), COLD URTICARIA (freezing rash around mouth), SPINAL PAIN (Spinal pain), PAIN IN EXTREMITY (sore arm), HYPERHIDROSIS (sweating) and INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (First Dose 27May2021/Second dose 20Aug2021). On an unknown date, the patient experienced VACCINATION SITE PAIN (Sore arm). On 20-Aug-2021, INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (First Dose 27May2021/Second dose 20Aug2021) had resolved. At the time of the report, SYNCOPE (faint), BODY TEMPERATURE ABNORMAL (temperature dropped to about 96 degrees F), FEELING ABNORMAL (feeling of shock happening), ARTHRITIS (Arthritis), DIZZINESS (dizzy), COLD URTICARIA (freezing rash around mouth), SPINAL PAIN (Spinal pain), PAIN IN EXTREMITY (sore arm), HYPERHIDROSIS (sweating) and VACCINATION SITE PAIN (Sore arm) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 27-May-2021, Body temperature: 96 (abnormal) 96 F.         No Concomitant medication was reported. No Treatment information was reported.  Company Comment: Based on the current available information and temporal association between the use of the product and the start date of events, a causal relationship cannot be excluded. Further information has been requested regarding event dates and seriousness criteria for syncope event.   This case was linked to MOD-2021-294517 (Patient Link).; Sender's Comments: Based on the current available information and temporal association between the use of the product and the start date of events, a causal relationship cannot be excluded. Further information has been requested regarding event dates and seriousness criteria for syncope event.
Age: 33.0
Sex: F
Vaccine: COVID19
Symptoms: Feeling abnormal, Hyperhidrosis, Inappropriate schedule of product administration, Pain in extremity, Spinal pain
Clinical narrative: Sore arm; First Dose 27May2021/Second dose 20Aug2021; faint; temperature dropped to about 96 degrees; feeling of shock happening; dizzy; freezing rash around mouth; Spinal pain; sore arm; sweating; Arthritis; This spontaneous case was reported by a consumer and describes the occurrence of SYNCOPE (faint) in a 33-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 088D21A and 050C21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.   On 27-May-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 20-Aug-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 27-May-2021, the patient experienced ARTHRITIS (Arthritis). On 20-Aug-2021, the patient experienced SYNCOPE (faint) (seriousness criterion medically significant), BODY TEMPERATURE ABNORMAL (temperature dropped to about 96 degrees F), FEELING ABNORMAL (feeling of shock happening), DIZZINESS (dizzy), COLD URTICARIA (freezing rash around mouth), SPINAL PAIN (Spinal pain), PAIN IN EXTREMITY (sore arm), HYPERHIDROSIS (sweating) and INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (First Dose 27May2021/Second dose 20Aug2021). On an unknown date, the patient experienced VACCINATION SITE PAIN (Sore arm). On 20-Aug-2021, INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (First Dose 27May2021/Second dose 20Aug2021) had resolved. At the time of the report, SYNCOPE (faint), BODY TEMPERATURE ABNORMAL (temperature dropped to about 96 degrees F), FEELING ABNORMAL (feeling of shock happening), ARTHRITIS (Arthritis), DIZZINESS (dizzy), COLD URTICARIA (freezing rash around mouth), SPINAL PAIN (Spinal pain), PAIN IN EXTREMITY (sore arm), HYPERHIDROSIS (sweating) and VACCINATION SITE PAIN (Sore arm) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 27-May-2021, Body temperature: 96 (abnormal) 96 F.         No Concomitant medication was reported. No Treatment information was reported.  Company Comment: Based on the current available information and temporal association between the use of the product and the start date of events, a causal relationship cannot be excluded. Further information has been requested regarding event dates and seriousness criteria for syncope event.   This case was linked to MOD-2021-294517 (Patient Link).; Sender's Comments: Based on the current available information and temporal association between the use of the product and the start date of events, a causal relationship cannot be excluded. Further information has been requested regarding event dates and seriousness criteria for syncope event.
Age: 33.0
Sex: F
Vaccine: COVID19
Symptoms: Syncope, Vaccination site pain
Clinical narrative: Sore arm; First Dose 27May2021/Second dose 20Aug2021; faint; temperature dropped to about 96 degrees; feeling of shock happening; dizzy; freezing rash around mouth; Spinal pain; sore arm; sweating; Arthritis; This spontaneous case was reported by a consumer and describes the occurrence of SYNCOPE (faint) in a 33-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 088D21A and 050C21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.   On 27-May-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 20-Aug-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 27-May-2021, the patient experienced ARTHRITIS (Arthritis). On 20-Aug-2021, the patient experienced SYNCOPE (faint) (seriousness criterion medically significant), BODY TEMPERATURE ABNORMAL (temperature dropped to about 96 degrees F), FEELING ABNORMAL (feeling of shock happening), DIZZINESS (dizzy), COLD URTICARIA (freezing rash around mouth), SPINAL PAIN (Spinal pain), PAIN IN EXTREMITY (sore arm), HYPERHIDROSIS (sweating) and INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (First Dose 27May2021/Second dose 20Aug2021). On an unknown date, the patient experienced VACCINATION SITE PAIN (Sore arm). On 20-Aug-2021, INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (First Dose 27May2021/Second dose 20Aug2021) had resolved. At the time of the report, SYNCOPE (faint), BODY TEMPERATURE ABNORMAL (temperature dropped to about 96 degrees F), FEELING ABNORMAL (feeling of shock happening), ARTHRITIS (Arthritis), DIZZINESS (dizzy), COLD URTICARIA (freezing rash around mouth), SPINAL PAIN (Spinal pain), PAIN IN EXTREMITY (sore arm), HYPERHIDROSIS (sweating) and VACCINATION SITE PAIN (Sore arm) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 27-May-2021, Body temperature: 96 (abnormal) 96 F.         No Concomitant medication was reported. No Treatment information was reported.  Company Comment: Based on the current available information and temporal association between the use of the product and the start date of events, a causal relationship cannot be excluded. Further information has been requested regarding event dates and seriousness criteria for syncope event.   This case was linked to MOD-2021-294517 (Patient Link).; Sender's Comments: Based on the current available information and temporal association between the use of the product and the start date of events, a causal relationship cannot be excluded. Further information has been requested regarding event dates and seriousness criteria for syncope event.
Age: 51.0
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, SARS-CoV-2 test
Clinical narrative: began having symptoms of Covid; This spontaneous case was reported by a consumer and describes the occurrence of COVID-19 (began having symptoms of Covid) in a 51-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 037B21A) for COVID-19 vaccination.     No Medical History information was reported.    On 30-Jul-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 09-Aug-2021, the patient experienced COVID-19 (began having symptoms of Covid). At the time of the report, COVID-19 (began having symptoms of Covid) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 13-Aug-2021, SARS-CoV-2 test: abnormal (Positive) tested positive for COVID.     The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No concomitant medication was reported.  No treatment information was reported.
Sex: M
Vaccine: COVID19
Symptoms: Arthralgia, Back pain, Hypokinesia, Inflammation, Rheumatoid arthritis
Clinical narrative: Joint inflammation, ankles, knees, and wrist inflammation, and was diagnosed with rheumatoid arthritis; 3 weeks later he started to have back and knee pain; 4 weeks after the vaccine, was when inflammation started to get severe/joint inflammation, ankles, knees, and wrist inflammation, and was diagnosed with rheumatoid arthritis; By 8 weeks, he could barely walk due to the pain from inflammation; 3 weeks later he started to have back and knee pain; This spontaneous case was reported by a consumer and describes the occurrence of RHEUMATOID ARTHRITIS (Joint inflammation, ankles, knees, and wrist inflammation, and was diagnosed with rheumatoid arthritis) in a male patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.   In May 2021, the patient 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 received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient experienced RHEUMATOID ARTHRITIS (Joint inflammation, ankles, knees, and wrist inflammation, and was diagnosed with rheumatoid arthritis) (seriousness criterion medically significant), BACK PAIN (3 weeks later he started to have back and knee pain), INFLAMMATION (4 weeks after the vaccine, was when inflammation started to get severe/joint inflammation, ankles, knees, and wrist inflammation, and was diagnosed with rheumatoid arthritis), HYPOKINESIA (By 8 weeks, he could barely walk due to the pain from inflammation) and ARTHRALGIA (3 weeks later he started to have back and knee pain). At the time of the report, RHEUMATOID ARTHRITIS (Joint inflammation, ankles, knees, and wrist inflammation, and was diagnosed with rheumatoid arthritis), BACK PAIN (3 weeks later he started to have back and knee pain), INFLAMMATION (4 weeks after the vaccine, was when inflammation started to get severe/joint inflammation, ankles, knees, and wrist inflammation, and was diagnosed with rheumatoid arthritis), HYPOKINESIA (By 8 weeks, he could barely walk due to the pain from inflammation) and ARTHRALGIA (3 weeks later he started to have back and knee pain) outcome was unknown.            Concomitant product was not provided by the reporter Lab data was not provided Treatment product was not provided by the reporter  Company comment: Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded.   This case was linked to MOD-2021-294210 (Patient Link).; Sender's Comments: Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded.
Age: 52.0
Sex: M
Vaccine: COVID19
Symptoms: Diarrhoea, Headache, Migraine, Somnolence
Clinical narrative: Migraines; Explosive diarrhea; Somnolence; Headaches; This spontaneous case was reported by a health care professional and describes the occurrence of MIGRAINE (Migraines), DIARRHOEA (Explosive diarrhea), SOMNOLENCE (Somnolence) and HEADACHE (Headaches) in a 52-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 049E21A and 036A21A) for COVID-19 vaccination.     The patient's past medical history included Cough (believes they had COVID-19 because they suffered having a bad cough back in 24Jan2020 through 15Feb2020) from 24-Jan-2020 to 15-Feb-2020. Concurrent medical conditions included Migraine. Concomitant products included FENTANYL, MORPHINE and TOPIRAMATE (TOPAMAX) for an unknown indication.   On 10-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 09-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 17-Aug-2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 18-Aug-2021, the patient experienced MIGRAINE (Migraines), DIARRHOEA (Explosive diarrhea), SOMNOLENCE (Somnolence) and HEADACHE (Headaches). The patient was treated with LOPERAMIDE HYDROCHLORIDE (IMODIUM) at an unspecified dose and frequency. On 22-Aug-2021, MIGRAINE (Migraines), DIARRHOEA (Explosive diarrhea), SOMNOLENCE (Somnolence) and HEADACHE (Headaches) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   Patient taken migraine medications.   This case was linked to MOD-2021-294571, MOD-2021-294576 (Patient Link).
Age: 47.0
Sex: M
Vaccine: COVID19
Symptoms: Arthralgia, Bedridden, Fatigue, Feeling hot, Hyperhidrosis
Clinical narrative: couldn't get out of bed; always hot now; sweats profusely; achiness started; running a fever for 2 days; achy joints; very tired; that evening he was sick/he says he's never been so sick in his life like after the vaccine; This spontaneous case was reported by a consumer and describes the occurrence of ILLNESS (that evening he was sick/he says he's never been so sick in his life like after the vaccine), BEDRIDDEN (couldn't get out of bed), FEELING HOT (always hot now), HYPERHIDROSIS (sweats profusely) and PAIN (achiness started) in a 47-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.     The patient's past medical history included COVID-19 (on Christmas 2020 for 2 days, mild) in December 2020.   In April 2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. In May 2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. In May 2021, the patient experienced ILLNESS (that evening he was sick/he says he's never been so sick in his life like after the vaccine). On an unknown date, the patient experienced BEDRIDDEN (couldn't get out of bed), FEELING HOT (always hot now), HYPERHIDROSIS (sweats profusely), PAIN (achiness started), PYREXIA (running a fever for 2 days), ARTHRALGIA (achy joints) and FATIGUE (very tired). The patient was treated with IBUPROFEN for Adverse event, at a dose of 1 dosage form. At the time of the report, ILLNESS (that evening he was sick/he says he's never been so sick in his life like after the vaccine), BEDRIDDEN (couldn't get out of bed), FEELING HOT (always hot now), HYPERHIDROSIS (sweats profusely), PAIN (achiness started), ARTHRALGIA (achy joints) and FATIGUE (very tired) outcome was unknown and PYREXIA (running a fever for 2 days) had resolved.            No concomitant medication details were provided.   This case was linked to MOD-2021-294579 (Patient Link).
Age: 47.0
Sex: M
Vaccine: COVID19
Symptoms: Illness, Pain, Pyrexia
Clinical narrative: couldn't get out of bed; always hot now; sweats profusely; achiness started; running a fever for 2 days; achy joints; very tired; that evening he was sick/he says he's never been so sick in his life like after the vaccine; This spontaneous case was reported by a consumer and describes the occurrence of ILLNESS (that evening he was sick/he says he's never been so sick in his life like after the vaccine), BEDRIDDEN (couldn't get out of bed), FEELING HOT (always hot now), HYPERHIDROSIS (sweats profusely) and PAIN (achiness started) in a 47-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.     The patient's past medical history included COVID-19 (on Christmas 2020 for 2 days, mild) in December 2020.   In April 2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. In May 2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. In May 2021, the patient experienced ILLNESS (that evening he was sick/he says he's never been so sick in his life like after the vaccine). On an unknown date, the patient experienced BEDRIDDEN (couldn't get out of bed), FEELING HOT (always hot now), HYPERHIDROSIS (sweats profusely), PAIN (achiness started), PYREXIA (running a fever for 2 days), ARTHRALGIA (achy joints) and FATIGUE (very tired). The patient was treated with IBUPROFEN for Adverse event, at a dose of 1 dosage form. At the time of the report, ILLNESS (that evening he was sick/he says he's never been so sick in his life like after the vaccine), BEDRIDDEN (couldn't get out of bed), FEELING HOT (always hot now), HYPERHIDROSIS (sweats profusely), PAIN (achiness started), ARTHRALGIA (achy joints) and FATIGUE (very tired) outcome was unknown and PYREXIA (running a fever for 2 days) had resolved.            No concomitant medication details were provided.   This case was linked to MOD-2021-294579 (Patient Link).
Age: 73.0
Sex: M
Vaccine: COVID19
Symptoms: Nasopharyngitis, SARS-CoV-2 test, Vaccination site swelling
Clinical narrative: Consumer also repots having a cold; Consumer reports significant swelling at injection site/muscle; This spontaneous case was reported by a consumer and describes the occurrence of NASOPHARYNGITIS (Consumer also repots having a cold) and VACCINATION SITE SWELLING (Consumer reports significant swelling at injection site/muscle) in a 73-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 026B21A and 036A21A) for COVID-19 vaccination.     The patient's past medical history included Pneumonia in February 2021 and COVID-19 (thinks may have been covid).   On 06-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 03-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 04-Apr-2021,  after starting mRNA-1273 (Moderna COVID-19 Vaccine), the patient experienced VACCINATION SITE SWELLING (Consumer reports significant swelling at injection site/muscle). On 18-Aug-2021, the patient experienced NASOPHARYNGITIS (Consumer also repots having a cold). The patient was treated with PARACETAMOL (TYLENOL) for Adverse event, at an unspecified dose and frequency. In April 2021, VACCINATION SITE SWELLING (Consumer reports significant swelling at injection site/muscle) had resolved. At the time of the report, NASOPHARYNGITIS (Consumer also repots having a cold) had not resolved.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 20-Aug-2021, SARS-CoV-2 test: negative (Negative) Negative.         No Concomitant medications were provided.
Sex: U
Vaccine: COVID19
Symptoms: Vaccination complication
Clinical narrative: reaction to her first dose of Moderna COVID19 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 VACCINATION COMPLICATION (reaction to her first dose of Moderna COVID19 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 dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced VACCINATION COMPLICATION (reaction to her first dose of Moderna COVID19 Vaccine). At the time of the report, VACCINATION COMPLICATION (reaction to her first dose of Moderna COVID19 Vaccine) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       The treatment history was not reported. The concomitant medication was not reported
Sex: M
Vaccine: COVID19
Symptoms: Coronavirus test positive, Drug ineffective
Clinical narrative: tested positive with Corona Virus; lack of drug effect; This spontaneous case was reported by a consumer and describes the occurrence of CORONAVIRUS TEST POSITIVE (tested positive with Corona Virus) and DRUG INEFFECTIVE (lack of drug effect) in a male patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 025C21A and 040B21A) for COVID-19 vaccination.     No Medical History information was reported.   On 09-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 07-May-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 27-Jul-2021, the patient experienced CORONAVIRUS TEST POSITIVE (tested positive with Corona Virus) and DRUG INEFFECTIVE (lack of drug effect). At the time of the report, CORONAVIRUS TEST POSITIVE (tested positive with Corona Virus) and DRUG INEFFECTIVE (lack of drug effect) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 27-Jul-2021, Coronavirus test positive: positive (Positive) Positive with Corona Virus.         Concomitant medications was not provided by the reporter. Treatment information was not provided.   This case was linked to MOD-2021-294138 (Patient Link).; Sender's Comments: Based on the mechanism of action of mRNA-1273, causal association between the event  Coronavirus test positive and mRNA-1273 is assessed as not applicable.
Sex: F
Vaccine: COVID19
Symptoms: Exposure during pregnancy
Clinical narrative: Received the moderna vaccine right at the beginning of pregnancy; This spontaneous prospective pregnancy case was reported by a consumer and describes the occurrence of EXPOSURE DURING PREGNANCY (Received the moderna vaccine right at the beginning of pregnancy) in a female patient of an unknown age 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 first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. Last menstrual period and estimated date of delivery were not provided. On an unknown date, the patient experienced EXPOSURE DURING PREGNANCY (Received the moderna vaccine right at the beginning of pregnancy). At the time of the report, EXPOSURE DURING PREGNANCY (Received the moderna vaccine right at the beginning of pregnancy) outcome was unknown. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       Concomitant product use was not provided by the reporter.   Treatment information was not provided.
Age: 67.0
Sex: F
Vaccine: COVID19
Symptoms: Infection
Clinical narrative: Have all had break-thru cases; This spontaneous case was reported by a consumer and describes the occurrence of INFECTION (Have all had break-thru cases) in a 67-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    In March 2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced INFECTION (Have all had break-thru cases). At the time of the report, INFECTION (Have all had break-thru cases) outcome was unknown. Not Provided          Concomitant product was not provided by the reporter. Treatment information was not provided.
Age: 66.0
Sex: M
Vaccine: COVID19
Symptoms: Cyst, Eye swelling, Feeling abnormal, Gout, Insomnia
Clinical narrative: severe entire body rash; little bit of rash in both injections; redness around the injection site; skin rash/ irritation; Has not been able to sleep for weeks; Itchy scalp/itchiness; eye almost 2 weeks swollen; gout in his knee; cyst in his left eye; body beeing completely abnormal/ scratching; body beeing completely abnormal/scratching; This spontaneous case was reported by a consumer and describes the occurrence of SKIN IRRITATION (skin rash/ irritation), INSOMNIA (Has not been able to sleep for weeks), PRURITUS (Itchy scalp/itchiness), EYE SWELLING (eye almost 2 weeks swollen) and GOUT (gout in his knee) in a 66-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.  Concomitant products included FISH OIL for an unknown indication.   In February 2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 04-Mar-2021 at 3:00 PM, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. In March 2021, the patient experienced SKIN IRRITATION (skin rash/ irritation), INSOMNIA (Has not been able to sleep for weeks), PRURITUS (Itchy scalp/itchiness), EYE SWELLING (eye almost 2 weeks swollen), GOUT (gout in his knee), CYST (cyst in his left eye), FEELING ABNORMAL (body beeing completely abnormal/ scratching), SCRATCH (body beeing completely abnormal/scratching), VACCINATION SITE RASH (little bit of rash in both injections) and VACCINATION SITE ERYTHEMA (redness around the injection site). On an unknown date, the patient experienced RASH (severe entire body rash). At the time of the report, SKIN IRRITATION (skin rash/ irritation), INSOMNIA (Has not been able to sleep for weeks), PRURITUS (Itchy scalp/itchiness), EYE SWELLING (eye almost 2 weeks swollen), GOUT (gout in his knee), CYST (cyst in his left eye), FEELING ABNORMAL (body beeing completely abnormal/ scratching), SCRATCH (body beeing completely abnormal/scratching), RASH (severe entire body rash), VACCINATION SITE RASH (little bit of rash in both injections) and VACCINATION SITE ERYTHEMA (redness around the injection site) outcome was unknown.            Concomitant medications also included supplements and Vitamins.  It was reported that patient consulted dermatologist but couldn't ruled out the nature of skin rash and its cause. Patient reported that he didn't experience such adverse events before  until the vaccine administration.  Treatment medication included steroid topical cream for reducing the itchiness irritation.   This case was linked to MOD-2021-294290 (Patient Link).
Age: 66.0
Sex: M
Vaccine: COVID19
Symptoms: Pruritus, Rash, Scratch, Skin irritation, Vaccination site erythema
Clinical narrative: severe entire body rash; little bit of rash in both injections; redness around the injection site; skin rash/ irritation; Has not been able to sleep for weeks; Itchy scalp/itchiness; eye almost 2 weeks swollen; gout in his knee; cyst in his left eye; body beeing completely abnormal/ scratching; body beeing completely abnormal/scratching; This spontaneous case was reported by a consumer and describes the occurrence of SKIN IRRITATION (skin rash/ irritation), INSOMNIA (Has not been able to sleep for weeks), PRURITUS (Itchy scalp/itchiness), EYE SWELLING (eye almost 2 weeks swollen) and GOUT (gout in his knee) in a 66-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.  Concomitant products included FISH OIL for an unknown indication.   In February 2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 04-Mar-2021 at 3:00 PM, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. In March 2021, the patient experienced SKIN IRRITATION (skin rash/ irritation), INSOMNIA (Has not been able to sleep for weeks), PRURITUS (Itchy scalp/itchiness), EYE SWELLING (eye almost 2 weeks swollen), GOUT (gout in his knee), CYST (cyst in his left eye), FEELING ABNORMAL (body beeing completely abnormal/ scratching), SCRATCH (body beeing completely abnormal/scratching), VACCINATION SITE RASH (little bit of rash in both injections) and VACCINATION SITE ERYTHEMA (redness around the injection site). On an unknown date, the patient experienced RASH (severe entire body rash). At the time of the report, SKIN IRRITATION (skin rash/ irritation), INSOMNIA (Has not been able to sleep for weeks), PRURITUS (Itchy scalp/itchiness), EYE SWELLING (eye almost 2 weeks swollen), GOUT (gout in his knee), CYST (cyst in his left eye), FEELING ABNORMAL (body beeing completely abnormal/ scratching), SCRATCH (body beeing completely abnormal/scratching), RASH (severe entire body rash), VACCINATION SITE RASH (little bit of rash in both injections) and VACCINATION SITE ERYTHEMA (redness around the injection site) outcome was unknown.            Concomitant medications also included supplements and Vitamins.  It was reported that patient consulted dermatologist but couldn't ruled out the nature of skin rash and its cause. Patient reported that he didn't experience such adverse events before  until the vaccine administration.  Treatment medication included steroid topical cream for reducing the itchiness irritation.   This case was linked to MOD-2021-294290 (Patient Link).
Age: 66.0
Sex: M
Vaccine: COVID19
Symptoms: Vaccination site rash
Clinical narrative: severe entire body rash; little bit of rash in both injections; redness around the injection site; skin rash/ irritation; Has not been able to sleep for weeks; Itchy scalp/itchiness; eye almost 2 weeks swollen; gout in his knee; cyst in his left eye; body beeing completely abnormal/ scratching; body beeing completely abnormal/scratching; This spontaneous case was reported by a consumer and describes the occurrence of SKIN IRRITATION (skin rash/ irritation), INSOMNIA (Has not been able to sleep for weeks), PRURITUS (Itchy scalp/itchiness), EYE SWELLING (eye almost 2 weeks swollen) and GOUT (gout in his knee) in a 66-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.  Concomitant products included FISH OIL for an unknown indication.   In February 2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 04-Mar-2021 at 3:00 PM, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. In March 2021, the patient experienced SKIN IRRITATION (skin rash/ irritation), INSOMNIA (Has not been able to sleep for weeks), PRURITUS (Itchy scalp/itchiness), EYE SWELLING (eye almost 2 weeks swollen), GOUT (gout in his knee), CYST (cyst in his left eye), FEELING ABNORMAL (body beeing completely abnormal/ scratching), SCRATCH (body beeing completely abnormal/scratching), VACCINATION SITE RASH (little bit of rash in both injections) and VACCINATION SITE ERYTHEMA (redness around the injection site). On an unknown date, the patient experienced RASH (severe entire body rash). At the time of the report, SKIN IRRITATION (skin rash/ irritation), INSOMNIA (Has not been able to sleep for weeks), PRURITUS (Itchy scalp/itchiness), EYE SWELLING (eye almost 2 weeks swollen), GOUT (gout in his knee), CYST (cyst in his left eye), FEELING ABNORMAL (body beeing completely abnormal/ scratching), SCRATCH (body beeing completely abnormal/scratching), RASH (severe entire body rash), VACCINATION SITE RASH (little bit of rash in both injections) and VACCINATION SITE ERYTHEMA (redness around the injection site) outcome was unknown.            Concomitant medications also included supplements and Vitamins.  It was reported that patient consulted dermatologist but couldn't ruled out the nature of skin rash and its cause. Patient reported that he didn't experience such adverse events before  until the vaccine administration.  Treatment medication included steroid topical cream for reducing the itchiness irritation.   This case was linked to MOD-2021-294290 (Patient Link).
Sex: U
Vaccine: COVID19
Symptoms: Nausea
Clinical narrative: within 24 hours, his coworkers experienced nausea and such; 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 NAUSEA (within 24 hours, his coworkers experienced nausea and such) 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 dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced NAUSEA (within 24 hours, his coworkers experienced nausea and such). At the time of the report, NAUSEA (within 24 hours, his coworkers experienced nausea and such) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No Concomitant drugs were reported.  No Treatment information  were reported.
Sex: U
Vaccine: COVID19
Symptoms: Axillary pain, Pain in extremity
Clinical narrative: Pain in my arm; Pain in my under arm; This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (Pain in my arm) and AXILLARY PAIN (Pain in my under arm) 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 first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced PAIN IN EXTREMITY (Pain in my arm) and AXILLARY PAIN (Pain in my under arm). At the time of the report, PAIN IN EXTREMITY (Pain in my arm) and AXILLARY PAIN (Pain in my under arm) had not resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No information on concomitant medications were reported.  No information on treatment medications were reported.  It had been a week and 2 days and  patient still have pain in  under arm and  arm.
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, Drug ineffective, Malaise, SARS-CoV-2 test
Clinical narrative: COVID-19; Lack of Efficacy; she felt sick; This spontaneous case was reported by a consumer and describes the occurrence of COVID-19 (COVID-19), DRUG INEFFECTIVE (Lack of Efficacy) and MALAISE (she felt sick) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 017B21A and 027A21A) for COVID-19 vaccination.     The patient's past medical history included Oral surgery (to have a tooth pulled) in August 2021.   On 10-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 07-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On an unknown date, the patient experienced COVID-19 (COVID-19), DRUG INEFFECTIVE (Lack of Efficacy) and MALAISE (she felt sick). At the time of the report, COVID-19 (COVID-19), DRUG INEFFECTIVE (Lack of Efficacy) and MALAISE (she felt sick) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, SARS-CoV-2 test: negative (Negative) Negative, negative (Negative) Negative and positive (Positive) Positive.         No concomitant medications were provided by reporter. No treatment medications were provided by reporter.; Sender's Comments: Based on the mechanism of action of mRNA-1273 causal association between the event of COVID-19 and mRNA-1273 is assessed as not applicable. For the rest of the events, based on the current available information and temporal association between the use of the product, and the start date of the events, a causal relationship cannot be excluded.
Sex: M
Vaccine: COVID19
Symptoms: COVID-19, SARS-CoV-2 test
Clinical narrative: son tested positive for COVID 19 and has full symptoms; This spontaneous case was reported by a consumer and describes the occurrence of COVID-19 (son tested positive for Covird 19 and has full symptoms) in a male patient of an unknown age 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 first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 20-Aug-2021, the patient experienced COVID-19 (son tested positive forCOVID19 and has full symptoms). At the time of the report, COVID-19 (son tested positive for COVID 19 and has full symptoms) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 20-Aug-2021, SARS-CoV-2 test: positive (Positive) Positive.     The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       The patient was scheduled for second dose on 30-Aug-2021.  No concomitant medications was reported.  No treatment drug details was reported.
Age: 65.0
Sex: F
Vaccine: COVID19
Symptoms: Pericarditis, Pleural effusion
Clinical narrative: Diagnosed with Pleural effusion; Diagnosed with Pericarditis; This spontaneous case was reported by a physician and describes the occurrence of PLEURAL EFFUSION (Diagnosed with Pleural effusion) and PERICARDITIS (Diagnosed with Pericarditis) in a 65-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 037520A and 0431200) for COVID-19 vaccination.     No Medical History information was reported.   On 23-Dec-2020, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 22-Jan-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 26-Jun-2021, the patient experienced PLEURAL EFFUSION (Diagnosed with Pleural effusion) (seriousness criterion hospitalization) and PERICARDITIS (Diagnosed with Pericarditis) (seriousness criteria hospitalization and medically significant). At the time of the report, PLEURAL EFFUSION (Diagnosed with Pleural effusion) and PERICARDITIS (Diagnosed with Pericarditis) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   Treatment medication was not provided by the reporter.  It was reported patient is taking medications for cholesterol, thyroid and all sorts of things that she has been on for years.  Patient reported that she was admitted in the hospital with Pericarditis and Pleural effusion on 26 June 2021 for three days and then admitted again on 04 July 2021 for another 6 days.  Company Comment: This case concerns a 65 year-old female patient who was hospitalized with reported pericarditis and pleural effusion 5 months and 4 days after receiving the second dose of the mRNA-1273 vaccine. Based on the current available information and temporal association between the use of the product and the start date of the event, a causal relationship cannot be excluded. Based on the current reference safety information, the event Pericarditis is considered listed. However, onset latency and clinical course are atypical and more information is required for further assessment.; Sender's Comments: This case concerns a 65 year-old female patient who was hospitalized with reported pericarditis and pleural effusion 5 months and 4 days after receiving the second dose of the mRNA-1273 vaccine. Based on the current available information and temporal association between the use of the product and the start date of the event, a causal relationship cannot be excluded. Based on the current reference safety information, the event Pericarditis is considered listed. However, onset latency and clinical course are atypical and more information is required for further assessment.
Age: 51.0
Sex: F
Vaccine: COVID19
Symptoms: Pruritus, Urticaria, Vaccination site urticaria, Vaccination site warmth
Clinical narrative: itchiness, very itchy; warm and hot; Hives; Like large hives (they were not small), like a know in the injection site; This spontaneous case was reported by a consumer and describes the occurrence of PRURITUS (itchiness, very itchy), VACCINATION SITE WARMTH (warm and hot), URTICARIA (Hives) and VACCINATION SITE URTICARIA (Like large hives (they were not small), like a know in the injection site) in a 51-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 002F21A) for COVID-19 vaccination.     No medical history was reported.  Concomitant products included TRAZODONE, MELOXICAM, ASPIRIN [ACETYLSALICYLIC ACID], OMEPRAZOLE and METOPROLOL for an unknown indication.    On 11-Aug-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced PRURITUS (itchiness, very itchy), VACCINATION SITE WARMTH (warm and hot), URTICARIA (Hives) and VACCINATION SITE URTICARIA (Like large hives (they were not small), like a know in the injection site). At the time of the report, PRURITUS (itchiness, very itchy), VACCINATION SITE WARMTH (warm and hot), URTICARIA (Hives) and VACCINATION SITE URTICARIA (Like large hives (they were not small), like a know in the injection site) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No treatment details were reported. Patient noticed the itchiness a few days ago. But the previous night, it was particularly itchy, and patient noticed she had like a knot in the injection site, like large hives (which were not small), it was warm and hot.
Sex: F
Vaccine: COVID19
Symptoms: Vaccination site pain
Clinical narrative: soreness at injection site; This spontaneous case was reported by a physician and describes the occurrence of VACCINATION SITE PAIN (soreness at injection site) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     Concurrent medical conditions included Endometrial carcinoma. Concomitant products included LENVATINIB MESILATE (LENVIMA) from 22-Jul-2021 to an unknown date for Endometrial carcinoma, PEMBROLIZUMAB (KEYTRUDA) for an unknown indication.    On 16-Aug-2021, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 18-Aug-2021, the patient experienced VACCINATION SITE PAIN (soreness at injection site). At the time of the report, VACCINATION SITE PAIN (soreness at injection site) outcome was unknown. Not Provided      For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   Concomitant product was not provided. Treatment information was not provided.
Sex: U
Vaccine: COVID19
Symptoms: Palpitations
Clinical narrative: My heart keep racing non stop for a week already; This spontaneous case was reported by a consumer and describes the occurrence of PALPITATIONS (My heart keep racing non stop for a week already) 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 dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced PALPITATIONS (My heart keep racing non stop for a week already). At the time of the report, PALPITATIONS (My heart keep racing non stop for a week already) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No Concomitent informations were reported. No Treament informations were reported.   Reporter did not allow further contact