chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 51.0
Sex: F
Vaccine: COVID19
Symptoms: Erythema, Eye pruritus, Hypersensitivity, Incorrect route of product administration, Pruritus
Clinical narrative: redness/erythema local; itching/pruritus local; local rash; Hypersensitivity reaction; Eye itching; wrong route of administration; This spontaneous case was reported by a consumer and describes the occurrence of HYPERSENSITIVITY (Hypersensitivity reaction), EYE PRURITUS (Eye itching), ERYTHEMA (redness/erythema local), PRURITUS (itching/pruritus local) and RASH (local rash) in a 51-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 047B21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     The patient's past medical history included Anaphylaxis and Bee sting (Lips,face started swelling, rash on chest, throat was getting tight) on 08-Jan-2012. Concurrent medical conditions included Gluten sensitivity, Food allergy (strawberries), Food allergy (vanilla), Allergy to chemicals (sulfur), Drug allergy (codine), Drug allergy (triamcinolone), Allergy to antibiotic (tetracycline) and Allergy to antibiotic (cipro).    On 06-Jun-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intravenous) 1 dosage form. On 06-Jun-2021,  after starting mRNA-1273 (Moderna COVID-19 Vaccine), the patient experienced INCORRECT ROUTE OF PRODUCT ADMINISTRATION (wrong route of administration). On 08-Jun-2021, the patient experienced HYPERSENSITIVITY (Hypersensitivity reaction) and EYE PRURITUS (Eye itching). On an unknown date, the patient experienced ERYTHEMA (redness/erythema local), PRURITUS (itching/pruritus local) and RASH (local rash). On 11-Jun-2021, HYPERSENSITIVITY (Hypersensitivity reaction) had resolved. At the time of the report, EYE PRURITUS (Eye itching) had not resolved and ERYTHEMA (redness/erythema local), PRURITUS (itching/pruritus local), RASH (local rash) and INCORRECT ROUTE OF PRODUCT ADMINISTRATION (wrong route of administration) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intravenous) was unknown.       This felt just like my reaction to steroid shots with the ingredient of triamcinolone in them. It wasn't as serious of reaction though. I took Benadryl every 4-6 hours until the itching stopped. My eye did not swell up very much, but it did have little bumps on the eyelid that were itching. My eye itself was fine.   Most recent FOLLOW-UP information incorporated above includes: On 09-Jun-2021: Additional information included reporter details and vaccination details On 30-Jun-2021: Follow up received includes new events and Medical history
Age: 51.0
Sex: F
Vaccine: COVID19
Symptoms: Rash
Clinical narrative: redness/erythema local; itching/pruritus local; local rash; Hypersensitivity reaction; Eye itching; wrong route of administration; This spontaneous case was reported by a consumer and describes the occurrence of HYPERSENSITIVITY (Hypersensitivity reaction), EYE PRURITUS (Eye itching), ERYTHEMA (redness/erythema local), PRURITUS (itching/pruritus local) and RASH (local rash) in a 51-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 047B21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     The patient's past medical history included Anaphylaxis and Bee sting (Lips,face started swelling, rash on chest, throat was getting tight) on 08-Jan-2012. Concurrent medical conditions included Gluten sensitivity, Food allergy (strawberries), Food allergy (vanilla), Allergy to chemicals (sulfur), Drug allergy (codine), Drug allergy (triamcinolone), Allergy to antibiotic (tetracycline) and Allergy to antibiotic (cipro).    On 06-Jun-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intravenous) 1 dosage form. On 06-Jun-2021,  after starting mRNA-1273 (Moderna COVID-19 Vaccine), the patient experienced INCORRECT ROUTE OF PRODUCT ADMINISTRATION (wrong route of administration). On 08-Jun-2021, the patient experienced HYPERSENSITIVITY (Hypersensitivity reaction) and EYE PRURITUS (Eye itching). On an unknown date, the patient experienced ERYTHEMA (redness/erythema local), PRURITUS (itching/pruritus local) and RASH (local rash). On 11-Jun-2021, HYPERSENSITIVITY (Hypersensitivity reaction) had resolved. At the time of the report, EYE PRURITUS (Eye itching) had not resolved and ERYTHEMA (redness/erythema local), PRURITUS (itching/pruritus local), RASH (local rash) and INCORRECT ROUTE OF PRODUCT ADMINISTRATION (wrong route of administration) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intravenous) was unknown.       This felt just like my reaction to steroid shots with the ingredient of triamcinolone in them. It wasn't as serious of reaction though. I took Benadryl every 4-6 hours until the itching stopped. My eye did not swell up very much, but it did have little bumps on the eyelid that were itching. My eye itself was fine.   Most recent FOLLOW-UP information incorporated above includes: On 09-Jun-2021: Additional information included reporter details and vaccination details On 30-Jun-2021: Follow up received includes new events and Medical history
Age: 62.0
Sex: M
Vaccine: COVID19
Symptoms: Fatigue, Headache, Night sweats, Pyrexia
Clinical narrative: Night sweats; Temp elevations; Severe headache; Fatigue; This spontaneous case was reported by a consumer and describes the occurrence of NIGHT SWEATS (Night sweats), PYREXIA (Temp elevations), HEADACHE (Severe headache) and FATIGUE (Fatigue) in a 62-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     The patient's past medical history included Lyme disease. Concurrent medical conditions included Dust allergy and Pollen allergy.   On 15-Apr-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. In 2021, the patient experienced NIGHT SWEATS (Night sweats), PYREXIA (Temp elevations), HEADACHE (Severe headache) and FATIGUE (Fatigue). At the time of the report, NIGHT SWEATS (Night sweats), PYREXIA (Temp elevations), HEADACHE (Severe headache) and FATIGUE (Fatigue) was resolving.       All the Laboratory tests have been negative.  Concomitant product use was not provided by the reporter.   No treatment information was provided.  Action taken with mRNA-1273 in response to the events was not applicable.  Company Comment: Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded. Further information has been requested.; 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. Further information has been requested.
Age: 50.0
Sex: F
Vaccine: COVID19
Symptoms: Dry mouth
Clinical narrative: dry mouth/severe dry mouth; This spontaneous case was reported by a consumer and describes the occurrence of DRY MOUTH (dry mouth/severe dry mouth) in a 50-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 100006) for COVID-19 vaccination.     Concurrent medical conditions included Blood pressure high.    On 04-May-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form once. On 04-Jun-2021,  after starting mRNA-1273 (Moderna COVID-19 Vaccine), the patient experienced DRY MOUTH (dry mouth/severe dry mouth). At the time of the report, DRY MOUTH (dry mouth/severe dry mouth) had not resolved.            Most recent FOLLOW-UP information incorporated above includes: On 14-Jun-2021: Non-Significant Follow-up added
Age: 50.0
Sex: M
Vaccine: COVID19
Symptoms: Abdominal pain upper, Chills, Myalgia
Clinical narrative: stomach pain; whole body ache; chills; This spontaneous case was reported by a consumer and describes the occurrence of ABDOMINAL PAIN UPPER (stomach pain), MYALGIA (whole body ache) and CHILLS (chills) in a 50-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.   On an unknown date, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 13-Jun-2021, the patient experienced MYALGIA (whole body ache) and CHILLS (chills). On an unknown date, the patient experienced ABDOMINAL PAIN UPPER (stomach pain). At the time of the report, ABDOMINAL PAIN UPPER (stomach pain) outcome was unknown and MYALGIA (whole body ache) and CHILLS (chills) had not resolved.            No concomitant medications were reported.  No treatment information was provided.   Most recent FOLLOW-UP information incorporated above includes: On 14-Jun-2021: Event start date updated. On 28-Jun-2021: New event added: stomach ache
Age: 64.0
Sex: F
Vaccine: COVID19
Symptoms: Alopecia
Clinical narrative: Hair loss on top of head; This spontaneous case was reported by a consumer and describes the occurrence of ALOPECIA (Hair loss on top of head) in a 64-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 041B21A and 048A21A) 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. On 15-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 12-May-2021, the patient experienced ALOPECIA (Hair loss on top of head). At the time of the report, ALOPECIA (Hair loss on top of head) had not resolved.            No relevant concomitant medications were reported.  No treatment information was provided.
Age: 55.0
Sex: F
Vaccine: COVID19
Symptoms: Diarrhoea
Clinical narrative: Gi issues, diarrhea after eating; This spontaneous case was reported by a consumer (subsequently medically confirmed) and describes the occurrence of DIARRHOEA (Gi issues, diarrhea after eating) in a 55-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 028A21A) for COVID-19 vaccination.     The patient's past medical history included No adverse event (No medical History Reported.).    On 27-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 28-Apr-2021, the patient experienced DIARRHOEA (Gi issues, diarrhea after eating). At the time of the report, DIARRHOEA (Gi issues, diarrhea after eating) had not resolved.            Reporter reports continues doctor's appointments , GI scopes and loss of time at work. Concomitant medications were not reported by the reporter. Treatment information was not reported by the reporter.
Age: 40.0
Sex: F
Vaccine: COVID19
Symptoms: Eye swelling
Clinical narrative: Swollen eyes; This spontaneous case was reported by a consumer and describes the occurrence of EYE SWELLING (Swollen eyes) in a 40-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 022b21a and 050c21a) for COVID-19 vaccination.     No Medical History information was reported.   On 17-May-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 14-Jun-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 16-Jun-2021, the patient experienced EYE SWELLING (Swollen eyes). At the time of the report, EYE SWELLING (Swollen eyes) had not resolved.       Patient  had dermal filers Consent for follow up declined.   Most recent FOLLOW-UP information incorporated above includes: On 16-Jun-2021: Follow Up received on 16-Jun-2021. Non-significant Follow up
Age: 48.0
Sex: F
Vaccine: COVID19
Symptoms: Migraine, Nausea, Urine analysis, Vomiting
Clinical narrative: Migraine; Nausea; Vomiting; This spontaneous case was reported by a consumer and describes the occurrence of MIGRAINE (Migraine), NAUSEA (Nausea) and VOMITING (Vomiting) in a 48-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 003C21A) for COVID-19 vaccination.     Concurrent medical conditions included Migraine and Chronic pain (chronic pain from auto accident).    On 02-May-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 02-May-2021, the patient experienced MIGRAINE (Migraine), NAUSEA (Nausea) and VOMITING (Vomiting). On 04-May-2021, MIGRAINE (Migraine), NAUSEA (Nausea) and VOMITING (Vomiting) had resolved.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, Urine analysis: positive for fentanyl (Positive) Positive for Fentanyl.     The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   Concomitant product use was not provided by the reporter. No treatment information was provided.
Age: 50.0
Sex: F
Vaccine: COVID19
Symptoms: Chest discomfort, Chest pain, Cough, Decreased appetite, Fatigue
Clinical narrative: Cough; sore throat; Not wanting to  eat; Pain in my chest.; Chest congestion; Headache; low grade fever; Spent 3weeks sleeping; I spent 3 weeks with fatigue; This spontaneous case was reported by a consumer and describes the occurrence of CHEST PAIN (Pain in my chest.), CHEST DISCOMFORT (Chest congestion), SOMNOLENCE (Spent 3weeks sleeping), COUGH (Cough) and OROPHARYNGEAL PAIN (sore throat) in a 50-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     Concurrent medical conditions included Hypothyroidism (autoimmune acquired hypothyroidism) and Food allergy (shrimp allergy).    On 23-May-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced CHEST PAIN (Pain in my chest.), CHEST DISCOMFORT (Chest congestion), SOMNOLENCE (Spent 3weeks sleeping), COUGH (Cough), OROPHARYNGEAL PAIN (sore throat), DECREASED APPETITE (Not wanting to  eat), FATIGUE (I spent 3 weeks with fatigue), HEADACHE (Headache) and PYREXIA (low grade fever). At the time of the report, CHEST PAIN (Pain in my chest.), DECREASED APPETITE (Not wanting to  eat), FATIGUE (I spent 3 weeks with fatigue) and HEADACHE (Headache) had not resolved and CHEST DISCOMFORT (Chest congestion), SOMNOLENCE (Spent 3weeks sleeping), COUGH (Cough), OROPHARYNGEAL PAIN (sore throat) and PYREXIA (low grade fever) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       Concomitant medications were not provided by the reporter. Treatment information was not provided.    Most recent FOLLOW-UP information incorporated above includes: On 18-Jun-2021: Live followup received, event decreased appetite and spent 3 weeks sleeping, updated.
Age: 50.0
Sex: F
Vaccine: COVID19
Symptoms: Headache, Oropharyngeal pain, Pyrexia, Somnolence
Clinical narrative: Cough; sore throat; Not wanting to  eat; Pain in my chest.; Chest congestion; Headache; low grade fever; Spent 3weeks sleeping; I spent 3 weeks with fatigue; This spontaneous case was reported by a consumer and describes the occurrence of CHEST PAIN (Pain in my chest.), CHEST DISCOMFORT (Chest congestion), SOMNOLENCE (Spent 3weeks sleeping), COUGH (Cough) and OROPHARYNGEAL PAIN (sore throat) in a 50-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     Concurrent medical conditions included Hypothyroidism (autoimmune acquired hypothyroidism) and Food allergy (shrimp allergy).    On 23-May-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced CHEST PAIN (Pain in my chest.), CHEST DISCOMFORT (Chest congestion), SOMNOLENCE (Spent 3weeks sleeping), COUGH (Cough), OROPHARYNGEAL PAIN (sore throat), DECREASED APPETITE (Not wanting to  eat), FATIGUE (I spent 3 weeks with fatigue), HEADACHE (Headache) and PYREXIA (low grade fever). At the time of the report, CHEST PAIN (Pain in my chest.), DECREASED APPETITE (Not wanting to  eat), FATIGUE (I spent 3 weeks with fatigue) and HEADACHE (Headache) had not resolved and CHEST DISCOMFORT (Chest congestion), SOMNOLENCE (Spent 3weeks sleeping), COUGH (Cough), OROPHARYNGEAL PAIN (sore throat) and PYREXIA (low grade fever) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       Concomitant medications were not provided by the reporter. Treatment information was not provided.    Most recent FOLLOW-UP information incorporated above includes: On 18-Jun-2021: Live followup received, event decreased appetite and spent 3 weeks sleeping, updated.
Age: 65.0
Sex: M
Vaccine: COVID19
Symptoms: Arthralgia
Clinical narrative: Chronic joint pain; This spontaneous case was reported by a consumer and describes the occurrence of ARTHRALGIA (Chronic joint pain) in a 65-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     taking an MAOI and pramipexzole Major depressive illness.  Concurrent medical conditions included Depressive illness (taking an MAOI and pramipexole  for Major depressive illness).    On 13-Mar-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 27-Mar-2021, the patient experienced ARTHRALGIA (Chronic joint pain). At the time of the report, ARTHRALGIA (Chronic joint pain) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   No relevant concomitant medications were reported.  No treatment information was provided.   Most recent FOLLOW-UP information incorporated above includes: On 24-Jun-2021: Non-significant follow-up.
Age: 56.0
Sex: F
Vaccine: COVID19
Symptoms: Anxiety, Depression, Palpitations, Tinnitus
Clinical narrative: Anxiety; Tinnitus; Palpitations; Depression; This spontaneous case was reported by a physician and describes the occurrence of ANXIETY (Anxiety), TINNITUS (Tinnitus), PALPITATIONS (Palpitations) and DEPRESSION (Depression) in a 56-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 026B21A) for COVID-19 vaccination.     Concurrent medical conditions included Migraine (Ocular migraine) and Anxiety.   On 05-Apr-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Subcutaneous) dosage was changed to 1 dosage form. On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 06-Apr-2021, the patient experienced ANXIETY (Anxiety), TINNITUS (Tinnitus), PALPITATIONS (Palpitations) and DEPRESSION (Depression). The patient was treated with DIAZEPAM (VALIUM) ongoing since an unknown date for Anxiety, at an unspecified dose and frequency. At the time of the report, ANXIETY (Anxiety), TINNITUS (Tinnitus), PALPITATIONS (Palpitations) and DEPRESSION (Depression) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter considered PALPITATIONS (Palpitations) and DEPRESSION (Depression) to be possibly related. No further causality assessments were provided for ANXIETY (Anxiety) and TINNITUS (Tinnitus).    Patient was using acupuncture treatment. No concomitant medication was reported. Physician seeing patient to evaluate for endocrine conditions.   Most recent FOLLOW-UP information incorporated above includes: On 24-Jun-2021: Additional information received included no new information.
Age: 72.0
Sex: M
Vaccine: COVID19
Symptoms: Hypoaesthesia, Monoplegia, X-ray
Clinical narrative: Left hand paralysis and numbness; Left hand paralysis and numbness; This spontaneous case was reported by a consumer and describes the occurrence of MONOPLEGIA (Left hand paralysis and numbness) in a 72-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 027A21A and 011A21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.   On 05-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 02-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 10-May-2021, the patient experienced MONOPLEGIA (Left hand paralysis and numbness) (seriousness criterion medically significant) and HYPOAESTHESIA (Left hand paralysis and numbness). At the time of the report, MONOPLEGIA (Left hand paralysis and numbness) and HYPOAESTHESIA (Left hand paralysis and numbness) had not resolved.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): In May 2021, X-ray: inconclusive (Inconclusive) No conclusive diagnosis.     For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   No concomitant medication was reported. No treatment information was provided.  Company Comment: Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded.; 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: 39.0
Sex: F
Vaccine: COVID19
Symptoms: Localised infection, Palpitations
Clinical narrative: Severe arm infection; chest palpitations; This spontaneous case was reported by a consumer and describes the occurrence of LOCALISED INFECTION (Severe arm infection) in a 39-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     Concurrent medical conditions included Asthma.    On 30-Jul-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 30-Jul-2021, the patient experienced LOCALISED INFECTION (Severe arm infection) (seriousness criterion medically significant) and PALPITATIONS (chest palpitations). At the time of the report, LOCALISED INFECTION (Severe arm infection) and PALPITATIONS (chest palpitations) had not resolved.            No concomitant medication details was reported. No treatment medication details was reported.  Company Comment: Very limited information regarding these events have been provided. Further information has been requested.; Sender's Comments: Very limited information regarding these events have been provided. Further information has been requested.
Age: 48.0
Sex: F
Vaccine: COVID19
Symptoms: Injection site nodule, Rash erythematous, Rash pruritic
Clinical narrative: 1 week to the day of vaccination, a painful, hard bump at injection site appeared along with an itchy red rash. Rash started quarter sized and ended baseball sized in diameter. It lasted 2 weeks.
Age: 50.0
Sex: F
Vaccine: COVID19
Symptoms: Breast tenderness, Chills, Headache, Impaired work ability, Injection site pain
Clinical narrative: Severe malaise, fever, chills, very sore arm at injection site, swollen lymph nodes under that arm, and severe tenderness of breast near that arm, headache, large rash at injection site
Age: 50.0
Sex: F
Vaccine: COVID19
Symptoms: Injection site rash, Lymphadenopathy, Malaise, Pyrexia
Clinical narrative: Severe malaise, fever, chills, very sore arm at injection site, swollen lymph nodes under that arm, and severe tenderness of breast near that arm, headache, large rash at injection site
Age: 57.0
Sex: M
Vaccine: COVID19
Symptoms: Neuralgia, Pain, Paraesthesia
Clinical narrative: Starting 2 approximately two weeks after second shot -  Tingling and sharp pain throughout pain. Feels like "nerve pain".  Is not consistent in any one location and varies of the severity. Is not related to shot location.
Age: 64.0
Sex: F
Vaccine: COVID19
Symptoms: Periarthritis
Clinical narrative: Frozen shoulder; This spontaneous case was reported by a physician and describes the occurrence of PERIARTHRITIS (Frozen shoulder) in a 64-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. UNKNOWN) for COVID-19 vaccination.     No Medical History information was reported.   On 12-Mar-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 first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced PERIARTHRITIS (Frozen shoulder) (seriousness criterion medically significant). At the time of the report, PERIARTHRITIS (Frozen shoulder) had not resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant medications were provided by the reporter. No treatment information was provided by the reporter.  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.; Sender's Comments: 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.
Age: 55.0
Sex: F
Vaccine: COVID19
Symptoms: Brain stem stroke, Visual field defect
Clinical narrative: Lost peripheral vision in the left eye; stroke in arterial blood vessel in brain; This spontaneous case was reported by a consumer and describes the occurrence of BRAIN STEM STROKE (stroke in arterial blood vessel in brain) and VISUAL FIELD DEFECT (Lost peripheral vision in the left eye) in a 55-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 03721A) for COVID-19 vaccination.     Concurrent medical conditions included Cervical dystonia and Herniated disc (Cervical, L5/S1 disc.).    On 01-Jun-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 milligram/kilogram. On 24-Jun-2021, the patient experienced BRAIN STEM STROKE (stroke in arterial blood vessel in brain) (seriousness criteria hospitalization and medically significant). On an unknown date, the patient experienced VISUAL FIELD DEFECT (Lost peripheral vision in the left eye) (seriousness criterion hospitalization). At the time of the report, BRAIN STEM STROKE (stroke in arterial blood vessel in brain) and VISUAL FIELD DEFECT (Lost peripheral vision in the left eye) outcome was unknown.            No concomitant medication reported. The patient was admitted in the hospital for stroke testing and treatment.  Very limited information regarding this event/s has been provided at this time. 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. Further information has been requested.; Sender's Comments: Very limited information regarding this event/s has been provided at this time. 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. Further information has been requested.
Age: 53.0
Sex: F
Vaccine: COVID19
Symptoms: Burning sensation, Hypoaesthesia, Neuropathy peripheral, SARS-CoV-2 antibody test
Clinical narrative: Burning, stabbing sensation in toes and feet; numbness in several toes; Peripheral neuropathy of toes, feet, ankles and wrists; This spontaneous case was reported by a consumer and describes the occurrence of NEUROPATHY PERIPHERAL (Peripheral neuropathy of toes, feet, ankles and wrists) in a 53-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 001B21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     The patient's past medical history included COVID-19 in December 2020. Concurrent medical conditions included Sulfonamide allergy (Reaction to sulfa). Concomitant products included GABAPENTIN for an unknown indication.   On 22-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 18-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 25-Apr-2021,  after starting mRNA-1273 (Moderna COVID-19 Vaccine), the patient experienced NEUROPATHY PERIPHERAL (Peripheral neuropathy of toes, feet, ankles and wrists) (seriousness criterion medically significant). On an unknown date, the patient experienced BURNING SENSATION (Burning, stabbing sensation in toes and feet) and HYPOAESTHESIA (numbness in several toes). At the time of the report, NEUROPATHY PERIPHERAL (Peripheral neuropathy of toes, feet, ankles and wrists) had not resolved and BURNING SENSATION (Burning, stabbing sensation in toes and feet) and HYPOAESTHESIA (numbness in several toes) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): In December 2020, SARS-CoV-2 antibody test: positive (Positive) Positive.     For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   Treatment medication was not provided  Company comment Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded.  However, more information is required for further assessment.; 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.  However, more information is required for further assessment.
Sex: F
Vaccine: PPV
Symptoms: Hypersensitivity
Clinical narrative: having an allergic reaction to Pneumovax 23; This spontaneous report as received from a nurse via Pfizer referring to currently 74-year-old female patient, referring to herself. The patient's concurrent condition, concomitant medication and medical history were not reported.   On an unknown date, the patient was vaccinated with pneumococcal vaccine, polyvalent (23-valent) (PNEUMOVAX23) (strength, dose, frequency, route of administration, indication, batch/lot# and expiration date were not reported) for prophylaxis. The patient had an allergic reaction to pneumococcal vaccine, polyvalent (23-valent) (PNEUMOVAX23). The outcome of the event was unknown. The event was related to pneumococcal vaccine, polyvalent (23-valent) (PNEUMOVAX23).
Sex: U
Vaccine: MMR, VARCEL
Symptoms: Incorrect route of product administration, No adverse event
Clinical narrative: VARlVAX and M-M-R II given intramuscular (IM) instead of subcutaneous (SC); Caller reported no further AE. No PQC reported.; This spontaneous report was received from a nurse practitioner, referring to a patient of unknown age and gender. The patient's pertinent medical history, drug reactions/allergies and concomitant therapies were not provided.      On 15-JUL-2021, the patient was vaccinated with varicella virus vaccine live (oka/merck) (VARIVAX) (lot # T032932, expiration date 28-SEP-2022) and measles, mumps, and rubella (wistar ra 27-3) virus vaccine, live (M-M-R II) (lot# T013725, expiration date 21-APR-2022) (0.5 ml; strength and frequency were not provided) via intramuscular (IM) route instead of subcutaneous (SC) route for prophylaxis (incorrect route of product administration). No further adverse event (AE) or product quality complaint (PQC) was reported.
Age: 7.0
Sex: M
Vaccine: HPV9
Symptoms: Injection site pain
Clinical narrative: he has soreness to his left deltoid, at the injection site; a 7 year old male inadvertently received GARDASIL 9.; This spontaneous report was received from a nurse referring to a 7 years old male patient. The patient's pertinent medical history, concomitant medication, drug reactions or allergies were reported as no. The patient's concurrent condition was not reported.  On 16-JUL-2021, the patient inadvertently received hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast) (GARDASIL 9) (lot # T026323, expiration date: 22-FEB-2023, 0.5 milliliter, strength was not reported) intramuscularly in the left deltoid for prophylaxis (Inappropriate age at vaccine administration).    On 16-JUL-2021 (at providers office at time of call), the patient had soreness to his left deltoid, at the injection site, but otherwise has no further complaints. No treatment given. No lab diagnostics/studies performed. The outcome was not reported. The causality assessment was not provided. combinationproductreport: Yes; brandname: GARDASIL 9 SYRINGE (DEVICE); commondevicename: HPV rL1 6 11 16 18 31 33 45 52 58 VLP vaccine (yeast); productcode: FMF; devicetype: SYRINGE, PISTON (FMF); manufacturername: Merck Sharp & Dohme Corp.; devicelotnumber: T026323; expirationdate: 22-FEB-2023; deviceage and unit: 0 ; malfunction: Unknown; deviceusage: Initial; reasonfornoneval: 81 Other; labeledsingleusedevice: No; mdcpreportability: No; mdcpreprationale: Case information does not meet criteria for reportability
Age: 71.0
Sex: M
Vaccine: HPV9
Symptoms: Product administered to patient of inappropriate age
Clinical narrative: Patient was not exhibiting any side effects at the time of the call/; inadvertent administration of GARDASIL 9 on 19Jul2021 to a 71 year old male patient, outside of Prescribing Information recommendations; This spontaneous report was received from a registered nurse concerning a 71-years-old male patient. The patient's pertinent medical history, concomitant therapies, drug reactions, or allergies were not reported.     On 19-JUL-2021, the patient was inadvertently administered one injection of HPV rL1 6 11 16 18 31 33 45 52 58 VLP vaccine (yeast) (GARDASIL 9) as prophylaxis, outside of prescribing information recommendations (product administered to patient of inappropriate age) (route and anatomical location of administration were not reported; lot number T027778 has been verified to be valid for syringe formulation, expiration date 27-FEB-2023).    As of reporting time, the patient was not exhibiting any side effects, and no other adverse events were not reported. combinationproductreport: Yes; brandname: GARDASIL 9 SYRINGE (DEVICE); commondevicename: HPV rL1 6 11 16 18 31 33 45 52 58 VLP vaccine (yeast); productcode: FMF; devicetype: SYRINGE, PISTON (FMF); manufacturername: Merck Sharp & Dohme Corp.; devicelotnumber: T027778; expirationdate: 27-FEB-2023; deviceage and unit: 0 ; malfunction: Unknown; deviceusage: Initial; reasonfornoneval: 81 Other; labeledsingleusedevice: No; mdcpreportability: No; mdcpreprationale: Case information does not meet criteria for reportability
Sex: M
Vaccine: MMR
Symptoms: Adverse reaction
Clinical narrative: adverse reaction; This spontaneous report was received from a consumer via Pfizer referring to a male patient of unknown age (the currently age also reported as 16 (unit unknown)). The patient's medical history, concurrent condition and concomitant medication were unknown    On an unknown date (reported as when he was younger), the patient was vaccinated with measles, mumps, and rubella (wistar ra 27-3) virus vaccine, live (M-M-R II) (strength, dose, route, lot# and expiration date were unknown) for prophylaxis.         On an unknown date, the patient had an adverse reaction to his measles, mumps, and rubella (wistar ra 27-3) virus vaccine, live (M-M-R II). The outcome of adverse reaction was unknown. The reporter considered adverse reaction to be related to Measles, Mumps, and Rubella (Wistar RA 27-3) Virus Vaccine, Live(M-M-R II).
Sex: U
Vaccine: MMR, VARCEL
Symptoms: Inappropriate schedule of product administration, Incorrect route of product administration
Clinical narrative: No additional adverse events reported; patient received M-M-R II and V ARlV AX vaccines on 7/13/2021 and again on 7/20/2021; Varivax administered intamuscularly; varivax administered intamuscularly; This spontaneous report was received from a physician's office referring to a 37- year- old patient of unknown gender.  Information regarding the patient's pertinent medical history, drug allergies, reactions or concomitant medications was not provided.  On 13-JUL-2021, the patient was vaccinated with Measles, Mumps, and Rubella (Wistar RA 27-3) Virus Vaccine, Live (M-M-R II) 0.5 milliliters (ml) intramuscular (anatomical location, lot number and expiration date were not reported) and varicella virus vaccine live (Oka/Merck) (VARIVAX) 0.5 milliliters (ml) intramuscular (incorrect route of product administration)(anatomical location, lot number and expiration date were not reported) for prophylaxis.  On 20-JUL-2021, the patient was vaccinated again with Measles, Mumps, and Rubella (Wistar RA 27-3) Virus Vaccine, Live (rHA (recombinant human albumin))(M-M-R II) 0.5 milliliters (ml) intramuscular, reported lot number: S036662 and expiration date: 14-NOV-2021 (anatomical location was not reported) and varicella virus vaccine live (Oka/Merck) (VARIVAX) 0.5 milliliters (ml) intramuscular (incorrect route of product administration) reported lot number: T000340 and expiration date 05-JAN-2022 (anatomical location, was not reported) for prophylaxis (inappropriate schedule of product administration).
Sex: U
Vaccine: HIBV
Symptoms: Expired product administered
Clinical narrative: No other signs or symptoms noted; patient was given expired PEDVAXHIB; This spontaneous report has been received from a nurse regarding to a patient of unknown age and gender. No information was provided regarding the patient's medical history, concurrent conditions, drug and allergy history or concomitant medications.  On 19-JUL-2021, the patient was vaccinated with an expired dose of haemophilus b conjugate vaccine (meningococcal protein conjugate)(LIQUID PEDVAXHIB) lot # R027322, expiration date 09-JUL-2021 (strength, dose and route of administration were not provided) for prophylaxis ( expired product administered). No other signs or symptoms were noted (no adverse event). Additionally, No previous temp excursion were reported. No further information was provided.
Age: 17.0
Sex: U
Vaccine: HPV9, HPV9
Symptoms: Inappropriate schedule of product administration, No adverse event
Clinical narrative: received 1st dose of GARDASIL 9 about one year ago, received the second dose on 6/28/2021.; No PQC or additional AEs reported.; This spontaneous report was received from a pharmacist referring a 17 years old patient of unknown gender. The patient's concurrent condition, pertinent medical history and concomitant medication were not reported.  In approximately 2020 (reported as one year ago), the patient received the first dose of hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast) (GARDASIL 9) (dose, strength, route, batch/lot# and expiration date were not reported) for prophylaxis. On 28-JUN-2021, the patient received the second dose of hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast) (GARDASIL 9) (0.5ml, lot#: T028582, expiration date: 04-MAR-2023, strength was not reported) intramuscularly for prophylaxis. No additional adverse events reported. combinationproductreport: Yes; brandname: GARDASIL 9 SYRINGE (DEVICE); commondevicename: HPV rL1 6 11 16 18 31 33 45 52 58 VLP vaccine (yeast); productcode: FMF; devicetype: SYRINGE, PISTON (FMF); manufacturername: Merck Sharp & Dohme Corp.;  devicelotnumber: T028582; expirationdate: 04-MAR-2023; deviceage and unit: 0 ; malfunction: Unknown; deviceusage: Initial; reasonfornoneval: 81 Other; labeledsingleusedevice: No; mdcpreportability: No; mdcpreprationale: Case information does not meet criteria for reportability
Age: 4.0
Sex: U
Vaccine: VARCEL
Symptoms: Product storage error
Clinical narrative: VARlVAX was administered after undergoing a temperature excursion; This spontaneous report was received from a medical assistant referring to a 4-year old patient of unknown gender.  The patient's medical history, concurrent condition and concomitant medication were unknown.    On 16-JUL-2021, the varicella virus vaccine live (oka/merck) (VARIVAX) (lot # T028310, expiration date 20-AUG-2022, indication: prophylaxis; strength and dose were unknown) was administered after undergoing a temperature excursion (product storage error).         Temperature excursion of this vaccine was 0.4 degree Celsius for 13 hours and 10 minutes. There was no previous temperature excursion. Data logger was involved.  This is one of several reports received from same reporter.; Sender's Comments:  US-009507513-2107USA006887: US-009507513-2107USA006957: US-009507513-2107USA007004: US-009507513-2107USA007009: US-009507513-2107USA006981: US-009507513-2107USA007007: US-009507513-2107USA007000:
Sex: F
Vaccine: MMR, VARCEL
Symptoms: Adverse reaction, Condition aggravated
Clinical narrative: had experienced a severe reaction to the M-M-R II and V ARlV AX vaccines; This spontaneous report was received from a consumer through a company representative referring to his daughter a 12 month old female patient. Information regarding the patient's pertinent medical history, concomitant therapies, drug reactions, or allergies was not reported.     On an unknown date, the patient was vaccinated with Measles, Mumps, and Rubella (Wistar RA 27-3) Virus Vaccine, Live (M-M-R II) (dose, route of administration, vaccination scheme frequency, anatomical location, lot number and expiration date were not reported)  and varicella virus vaccine live (Oka/Merck) (VARIVAX) (dose, route of administration, vaccination scheme frequency and anatomical location were not reported) (lot number T033166 and expiration date 29-SEP-2022) , and both suspect vaccines were administered as prophylaxis.    On an unknown date the patient experienced a severe adverse reaction to the  Measles, Mumps, and Rubella (Wistar RA 27-3) Virus Vaccine, Live (M-M-R II) and varicella virus vaccine live (Oka/Merck) (VARIVAX) (vaccination complication). The patient's father sought medical attention with 5 different doctors and none of them had ever seen a reaction so severe. It was unknown if the patient received treatment or if any lab diagnostics were performed. It was reported that the patient's condition was getting progressively worse; therefore, by the reporting time, she had not recovered from the vaccine complication.   The causality assessment between Measles, Mumps, and Rubella (Wistar RA 27-3) Virus Vaccine, Live (M-M-R II) and varicella virus vaccine live (Oka/Merck) (VARIVAX) and the event vaccination complication was considered to be related.
Age: 48.0
Sex: M
Vaccine: PPV
Symptoms: Inappropriate schedule of product administration
Clinical narrative: Pneumovax 23 was vaccinated on 1212/2009 and 07/17/2012; This spontaneous report has been received from a lawyer, via a Plaintiff immunization records from a case in litigation for zoster vaccine live (ZOSTAVAX) (MARRS # 1901USA004702), concerning a 50 years old male patient. No information was received regarding the patient's past medical history, concurrent conditions, or concomitant medication.   The patient was administered pneumococcal vaccine polyvalent (23-valent) (PNEUMOVAX 23) (0.5ml, route, strength, batch/lot # and expiration date were not reported) on 12-DEC-2009 and pneumococcal vaccine polyvalent (23-valent) (PNEUMOVAX 23) (0.5 (unit not provided), route, strength, batch/lot # and expiration date were not reported) on 17-JUL-2012 (Inappropriate Schedule of Vaccine administered).  This is one of the two reports concerning the same patient.; Sender's Comments:  US-009507513-1901USA004702:
Age: 38.0
Sex: U
Vaccine: VARCEL
Symptoms: Expired product administered, No adverse event
Clinical narrative: No additional adverse events reported; Nurse reports the dose of VARIVAX expired on 07/22/2021; This spontaneous report as received from a registered nurse refers to a 38 years old patient of unknown gender. The patient's medical history, concurrent condition and concomitant medication were not reported.   On 26-JUL-2021, the patient was vaccinated with a dose of expired varicella virus vaccine live (oka/merck)(VARIVAX) (lot # S022757, expiration date 22-JUL-2021, 0.5 milliliter) for prophylaxis (expired product administered). The expiration date was found supported by memo with no temperature excursion. No additional information given. No additional adverse events reported.
Age: 63.0
Sex: F
Vaccine: PPV
Symptoms: Inappropriate schedule of product administration, No adverse event
Clinical narrative: no adverse event; pneumococcal vaccine (unspecified) administered in 2018 and 2020; This spontaneous report has been received from a physician and a lawyer, via a medical records and fact sheet from a case in litigation for zoster vaccine live (ZOSTAVAX) (MARRS # 2103USA008101), concerning to an approximately 65 years old female patient. No information was received regarding the patient's past medical history, concurrent conditions, or concomitant medication.   The patient was administered pneumococcal vaccine polyvalent (23-valent) (manufacturer unknown) (dose, route, strength, batch/lot # and expiration date were not reported) in 2018 (reported as onset: 2 years of office visit 22-OCT-2020) and pneumococcal vaccine polyvalent (23-valent) (manufacturer unknown) (dose, route, strength, batch/lot # and expiration date were not reported) in 2020 (Inappropriate Schedule of Vaccine administered). No adverse event was reported.  This is one of the two reports concerning the same patient.; Sender's Comments:  US-009507513-2103USA008101:
Sex: U
Vaccine: HEPA
Symptoms: Product storage error
Clinical narrative: no adverse event; a needle was attached to a prefilled VAQTA syringe and placed in a refrigerator. Today, the patient received that VAQTA; This spontaneous report was received from a nurse referring to a patient of unknown age or gender. The patient's concurrent conditions, medical history and concomitant therapies were not reported.  On 26-JUL-2021 (reported as yesterday), a needle was attached to a prefilled hepatitis a vaccine, inactivated(VAQTA) syringe and placed in a refrigerator.  On 27-JUL-2021 (reported as today), the patient was vaccinated with hepatitis a vaccine, inactivated(VAQTA) 0.5ml once, lot # T037329, expiration date on 30-APR-2022, for prophylaxis. This adverse event was reported since the nurse wanted to discard that vaccine at the end of the day but instead it was given the next day. No product quality complaint and no further information was available. combinationproductreport: Yes; brandname: VAQTA SYRINGE (DEVICE); commondevicename: Hepatitis A Vaccine, Inactivated; productcode: FMF; devicetype: SYRINGE, PISTON (FMF); manufacturername: Merck Sharp & Dohme Corp.; devicelotnumber: T037329; expirationdate: 30-APR-2022; deviceage and unit: 0; malfunction: Unknown; deviceusage: Initial; reasonfornoneval: 81 Other; labeledsingleusedevice: No; mdcpreportability: No; mdcpreprationale: Case information does not meet criteria for reportability