chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 53.0
Sex: F
Vaccine: COVID19
Symptoms: Injection site erythema, Injection site hypoaesthesia, Injection site swelling, Injection site warmth
Clinical narrative: it is reddish, raised, warm and numb; small spot at the injection site / it is reddish, raised, warm and numb; it is reddish, raised, warm and numb /  2.5-3 inch swollen circle at the injection site; it is reddish, raised, warm and numb; This spontaneous case was reported by an other caregiver and describes the occurrence of INJECTION SITE WARMTH (small spot at the injection site / it is reddish, raised, warm and numb), INJECTION SITE HYPOAESTHESIA (it is reddish, raised, warm and numb), INJECTION SITE SWELLING (it is reddish, raised, warm and numb /  2.5-3 inch swollen circle at the injection site) and INJECTION SITE ERYTHEMA (it is reddish, raised, warm and numb) in a 53-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 025B21A) for COVID-19 vaccination.     Concomitant products included LEVOTHYROXINE SODIUM (SYNTHROID) and FOMEPIZOLE for an unknown indication.    On 31-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 12-Apr-2021, the patient experienced INJECTION SITE WARMTH (small spot at the injection site / it is reddish, raised, warm and numb), INJECTION SITE HYPOAESTHESIA (it is reddish, raised, warm and numb), INJECTION SITE SWELLING (it is reddish, raised, warm and numb /  2.5-3 inch swollen circle at the injection site) and INJECTION SITE ERYTHEMA (it is reddish, raised, warm and numb). At the time of the report, INJECTION SITE WARMTH (small spot at the injection site / it is reddish, raised, warm and numb), INJECTION SITE HYPOAESTHESIA (it is reddish, raised, warm and numb), INJECTION SITE SWELLING (it is reddish, raised, warm and numb /  2.5-3 inch swollen circle at the injection site) and INJECTION SITE ERYTHEMA (it is reddish, raised, warm and numb) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No laboratory details were  provided.  No treatment medications were reported.    Most recent FOLLOW-UP information incorporated above includes: On 17-May-2021: TCR: Outcome of AE updated
Sex: F
Vaccine: COVID19
Symptoms: Herpes zoster, Urticaria
Clinical narrative: hives; shingles; This spontaneous case was reported by a consumer and describes the occurrence of URTICARIA (hives) and HERPES ZOSTER (shingles) in a 64-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 045A21A) for COVID-19 vaccination.     The patient's past medical history included No adverse event. Concomitant products included ROSUVASTATIN, METOPROLOL, TRAZODONE, BUPROPION HCL, HYDROCHLOROTHIAZIDE and ACETYLSALICYLIC ACID (ASPIRIN 81) for an unknown indication, CYANOCOBALAMIN, FOLIC ACID (VITAMIN B12 & FOLIC ACID).   On 19-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to at an unspecified dose. On an unknown date, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) at an unspecified dose. On 23-Mar-2021, the patient experienced URTICARIA (hives) and HERPES ZOSTER (shingles). At the time of the report, URTICARIA (hives) and HERPES ZOSTER (shingles) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown Route) and mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.
Age: 40.0
Sex: M
Vaccine: COVID19
Symptoms: Chills, Pain in extremity
Clinical narrative: pain in the arm of the injection; chills; This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (pain in the arm of the injection) and CHILLS (chills) in a 40-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     The patient's past medical history included No adverse event (No reported medical history).    On 10-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 10-Apr-2021, the patient experienced PAIN IN EXTREMITY (pain in the arm of the injection) and CHILLS (chills). At the time of the report, PAIN IN EXTREMITY (pain in the arm of the injection) had not resolved and CHILLS (chills) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Patient reported treatment with Acetaminophen on 10-Apr-2021. No concomitant drugs were reported.   This case was linked to MOD-2021-073690, MOD-2021-073840 (Patient Link).
Sex: F
Vaccine: COVID19
Symptoms: Chills, Headache, Insomnia, Nausea, Pain in extremity
Clinical narrative: could not sleep; arm much more sore; chills; fever; nauseated; headache; This case was received via an unknown source (no reference has been entered for a health authority or license partner) on 09-Apr-2021 and was forwarded to Moderna on 09-Apr-2021.    This spontaneous case was reported by a consumer and describes the occurrence of INSOMNIA (could not sleep), PAIN IN EXTREMITY (arm much more sore), CHILLS (chills), PYREXIA (fever) and NAUSEA (nauseated) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.    On 08-Apr-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 08-Apr-2021, the patient experienced INSOMNIA (could not sleep), PAIN IN EXTREMITY (arm much more sore), CHILLS (chills), PYREXIA (fever), NAUSEA (nauseated) and HEADACHE (headache). At the time of the report, INSOMNIA (could not sleep), PAIN IN EXTREMITY (arm much more sore), CHILLS (chills), PYREXIA (fever), NAUSEA (nauseated) and HEADACHE (headache) outcome was unknown.            Concomitant product use was not provided by the reporter.  No treatment information was provided.   Reporter did not allow further contact
Sex: F
Vaccine: COVID19
Symptoms: Pyrexia
Clinical narrative: could not sleep; arm much more sore; chills; fever; nauseated; headache; This case was received via an unknown source (no reference has been entered for a health authority or license partner) on 09-Apr-2021 and was forwarded to Moderna on 09-Apr-2021.    This spontaneous case was reported by a consumer and describes the occurrence of INSOMNIA (could not sleep), PAIN IN EXTREMITY (arm much more sore), CHILLS (chills), PYREXIA (fever) and NAUSEA (nauseated) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.    On 08-Apr-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 08-Apr-2021, the patient experienced INSOMNIA (could not sleep), PAIN IN EXTREMITY (arm much more sore), CHILLS (chills), PYREXIA (fever), NAUSEA (nauseated) and HEADACHE (headache). At the time of the report, INSOMNIA (could not sleep), PAIN IN EXTREMITY (arm much more sore), CHILLS (chills), PYREXIA (fever), NAUSEA (nauseated) and HEADACHE (headache) outcome was unknown.            Concomitant product use was not provided by the reporter.  No treatment information was provided.   Reporter did not allow further contact
Age: 68.0
Sex: F
Vaccine: COVID19
Symptoms: Arthralgia, Hypokinesia, Incorrect route of product administration
Clinical narrative: she hasn't been able to move her shoulder; severe pain in her left shoulder; she says she did not receive the vaccine on the deltoid; This spontaneous case was reported by a consumer (subsequently medically confirmed) and describes the occurrence of HYPOKINESIA (she hasn't been able to move her shoulder), ARTHRALGIA (severe pain in her left shoulder) and INCORRECT ROUTE OF PRODUCT ADMINISTRATION (she says she did not receive the vaccine on the deltoid) in a 68-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 032M20A) for COVID-19 vaccination.     No medical history was provided.  Concomitant products included LISINOPRIL for an unknown indication.    On 27-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 27-Mar-2021, the patient experienced INCORRECT ROUTE OF PRODUCT ADMINISTRATION (she says she did not receive the vaccine on the deltoid). On 28-Mar-2021, the patient experienced HYPOKINESIA (she hasn't been able to move her shoulder) and ARTHRALGIA (severe pain in her left shoulder). On 27-Mar-2021, INCORRECT ROUTE OF PRODUCT ADMINISTRATION (she says she did not receive the vaccine on the deltoid) had resolved. At the time of the report, HYPOKINESIA (she hasn't been able to move her shoulder) and ARTHRALGIA (severe pain in her left shoulder) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Patient took ibuprofen as treatment for the events.   Most recent FOLLOW-UP information incorporated above includes: On 18-May-2021: Non-significant follow up appended.
Sex: F
Vaccine: COVID19
Symptoms: Chills, Headache, Illness, Myalgia, Pyrexia
Clinical narrative: very sick; body aches; headache; chills; low grade fever; This spontaneous case was reported by a consumer (subsequently medically confirmed) and describes the occurrence of ILLNESS (very sick), MYALGIA (body aches), HEADACHE (headache), CHILLS (chills) and PYREXIA (low grade fever) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 immunization.     The patient's past medical history included No adverse event.    On 16-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1. On an unknown date, the patient experienced ILLNESS (very sick), MYALGIA (body aches), HEADACHE (headache), CHILLS (chills) and PYREXIA (low grade fever). At the time of the report, ILLNESS (very sick), MYALGIA (body aches), HEADACHE (headache), CHILLS (chills) and PYREXIA (low grade fever) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Patient reports already seeing doctor for the symptoms.  No concomitant medications reported. No treatment reported.   Reporter did not allow further contact
Sex: M
Vaccine: COVID19
Symptoms: Inappropriate schedule of product administration, Intentional product use issue
Clinical narrative: patient received second dose 3 days after first; patient received second dose 3 days after first; This spontaneous case was reported by a pharmacist and describes the occurrence of INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (patient received second dose 3 days after first) and INTENTIONAL PRODUCT USE ISSUE (patient received second dose 3 days after first) in a male patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     The patient's past medical history included No adverse event (No relevant medical history provided).   On 09-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 12-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 12-Apr-2021, the patient experienced INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (patient received second dose 3 days after first) and INTENTIONAL PRODUCT USE ISSUE (patient received second dose 3 days after first). On 12-Apr-2021, INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (patient received second dose 3 days after first) and INTENTIONAL PRODUCT USE ISSUE (patient received second dose 3 days after first) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   The patient's medical history  and relevant concomitant medications weren't reported Treatment information was not provided
Age: 76.0
Sex: F
Vaccine: COVID19
Symptoms: Chills, Dysuria, Fatigue, Headache, Myalgia
Clinical narrative: This spontaneous case was reported by a consumer (subsequently medically confirmed) and describes the occurrence of URINARY TRACT INFECTION (diagnosed with urinary track infection), POLLAKIURIA (urinating once an hour), DYSURIA (pain when urinating), VACCINATION SITE INDURATION (hardness around the injection site) and HEADACHE (headache) in a 76-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 Neuropathy since an unknown date. Concomitant products included ACETYLSALICYLIC ACID (BABY ASPIRIN), GABAPENTIN (NEURONTIN) and CHLORPHENAMINE MALEATE (ANTIHISTAMIN) for an unknown indication. On 12-Mar-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 2 dosage form. On 12-Feb-2021, the patient experienced VACCINATION SITE INDURATION (hardness around the injection site). On 13-Mar-2021, the patient experienced POLLAKIURIA (urinating once an hour), HEADACHE (headache), MYALGIA (muscle pain), FATIGUE (fatigue, felt exhausted), CHILLS (chills), NAUSEA (nausea) and PYREXIA (fever of 101°F). On 14-Mar-2021, the patient experienced DYSURIA (pain when urinating). On 15-Mar-2021, the patient experienced URINARY TRACT INFECTION (diagnosed with urinary track infection). On 14-Feb-2021, VACCINATION SITE INDURATION (hardness around the injection site) had resolved. At the time of the report, URINARY TRACT INFECTION (diagnosed with urinary track infection), POLLAKIURIA (urinating once an hour), DYSURIA (pain when urinating), HEADACHE (headache), MYALGIA (muscle pain), FATIGUE (fatigue, felt exhausted), CHILLS (chills), NAUSEA (nausea) and PYREXIA (fever of 101°F) outcome was unknown. DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 13-Mar-2021, Pyrexia: high (High) 101F. For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments. Received Tylenol for the first couple of days after second dose on 12-Mar-2021. Received treatment antibiotic Nitrofurazone for 2 days and Sulfamethoxazole 400 mg for 5 days. Lab tests were performed to confirm a E.coli infection. No other information was reported. Company comment: Based on the current available information and the temporal association between the product use and the start date of the events a causal relationship cannot be excluded. This case was linked to MOD-2021-073620 (E2B Linked Report).; Sender's Comments: Based on the current available information and the temporal association between the product use and the start date of the events a causal relationship cannot be excluded. MOD-2021-073620:first dose case.
Age: 76.0
Sex: F
Vaccine: COVID19
Symptoms: Nausea, Pollakiuria, Pyrexia, Urinary tract infection, Vaccination site induration
Clinical narrative: This spontaneous case was reported by a consumer (subsequently medically confirmed) and describes the occurrence of URINARY TRACT INFECTION (diagnosed with urinary track infection), POLLAKIURIA (urinating once an hour), DYSURIA (pain when urinating), VACCINATION SITE INDURATION (hardness around the injection site) and HEADACHE (headache) in a 76-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 Neuropathy since an unknown date. Concomitant products included ACETYLSALICYLIC ACID (BABY ASPIRIN), GABAPENTIN (NEURONTIN) and CHLORPHENAMINE MALEATE (ANTIHISTAMIN) for an unknown indication. On 12-Mar-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 2 dosage form. On 12-Feb-2021, the patient experienced VACCINATION SITE INDURATION (hardness around the injection site). On 13-Mar-2021, the patient experienced POLLAKIURIA (urinating once an hour), HEADACHE (headache), MYALGIA (muscle pain), FATIGUE (fatigue, felt exhausted), CHILLS (chills), NAUSEA (nausea) and PYREXIA (fever of 101°F). On 14-Mar-2021, the patient experienced DYSURIA (pain when urinating). On 15-Mar-2021, the patient experienced URINARY TRACT INFECTION (diagnosed with urinary track infection). On 14-Feb-2021, VACCINATION SITE INDURATION (hardness around the injection site) had resolved. At the time of the report, URINARY TRACT INFECTION (diagnosed with urinary track infection), POLLAKIURIA (urinating once an hour), DYSURIA (pain when urinating), HEADACHE (headache), MYALGIA (muscle pain), FATIGUE (fatigue, felt exhausted), CHILLS (chills), NAUSEA (nausea) and PYREXIA (fever of 101°F) outcome was unknown. DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 13-Mar-2021, Pyrexia: high (High) 101F. For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments. Received Tylenol for the first couple of days after second dose on 12-Mar-2021. Received treatment antibiotic Nitrofurazone for 2 days and Sulfamethoxazole 400 mg for 5 days. Lab tests were performed to confirm a E.coli infection. No other information was reported. Company comment: Based on the current available information and the temporal association between the product use and the start date of the events a causal relationship cannot be excluded. This case was linked to MOD-2021-073620 (E2B Linked Report).; Sender's Comments: Based on the current available information and the temporal association between the product use and the start date of the events a causal relationship cannot be excluded. MOD-2021-073620:first dose case.
Age: 47.0
Sex: M
Vaccine: COVID19
Symptoms: Chills, Diarrhoea, Hyperhidrosis, Illness, Migraine
Clinical narrative: mightily, described as being sick / deathly ill since receiving the series; chills; shakes; fever / fever of 102.5 degrees; sweats; nausea; diarrhea; migraine headache; a sore injection arm / continued to hurt for the entire month; This spontaneous case was reported by a non-health professional and describes the occurrence of ILLNESS (mightily, described as being sick / deathly ill since receiving the series), CHILLS (chills), TREMOR (shakes), PYREXIA (fever / fever of 102.5 degrees) and HYPERHIDROSIS (sweats) 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 Migraine headache (baseline history migraine headache).   On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to at an unspecified dose. On an unknown date, the patient experienced ILLNESS (mightily, described as being sick / deathly ill since receiving the series), CHILLS (chills), TREMOR (shakes), PYREXIA (fever / fever of 102.5 degrees), HYPERHIDROSIS (sweats), NAUSEA (nausea), DIARRHOEA (diarrhea), MIGRAINE (migraine headache) and MYALGIA (a sore injection arm / continued to hurt for the entire month). At the time of the report, ILLNESS (mightily, described as being sick / deathly ill since receiving the series), CHILLS (chills), TREMOR (shakes), PYREXIA (fever / fever of 102.5 degrees), HYPERHIDROSIS (sweats), NAUSEA (nausea), DIARRHOEA (diarrhea), MIGRAINE (migraine headache) and MYALGIA (a sore injection arm / continued to hurt for the entire month) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       patient applied ice for hurting arm and taken ibruprofen medication   This case was linked to US-MODERNATX, INC.-MOD-2021-073648 (Linked Report).; Sender's Comments:  US-MODERNATX, INC.-MOD-2021-073648:2nd dose case
Age: 47.0
Sex: M
Vaccine: COVID19
Symptoms: Myalgia, Nausea, Pyrexia, Tremor
Clinical narrative: mightily, described as being sick / deathly ill since receiving the series; chills; shakes; fever / fever of 102.5 degrees; sweats; nausea; diarrhea; migraine headache; a sore injection arm / continued to hurt for the entire month; This spontaneous case was reported by a non-health professional and describes the occurrence of ILLNESS (mightily, described as being sick / deathly ill since receiving the series), CHILLS (chills), TREMOR (shakes), PYREXIA (fever / fever of 102.5 degrees) and HYPERHIDROSIS (sweats) 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 Migraine headache (baseline history migraine headache).   On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to at an unspecified dose. On an unknown date, the patient experienced ILLNESS (mightily, described as being sick / deathly ill since receiving the series), CHILLS (chills), TREMOR (shakes), PYREXIA (fever / fever of 102.5 degrees), HYPERHIDROSIS (sweats), NAUSEA (nausea), DIARRHOEA (diarrhea), MIGRAINE (migraine headache) and MYALGIA (a sore injection arm / continued to hurt for the entire month). At the time of the report, ILLNESS (mightily, described as being sick / deathly ill since receiving the series), CHILLS (chills), TREMOR (shakes), PYREXIA (fever / fever of 102.5 degrees), HYPERHIDROSIS (sweats), NAUSEA (nausea), DIARRHOEA (diarrhea), MIGRAINE (migraine headache) and MYALGIA (a sore injection arm / continued to hurt for the entire month) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       patient applied ice for hurting arm and taken ibruprofen medication   This case was linked to US-MODERNATX, INC.-MOD-2021-073648 (Linked Report).; Sender's Comments:  US-MODERNATX, INC.-MOD-2021-073648:2nd dose case
Age: 45.0
Sex: F
Vaccine: COVID19
Symptoms: Chills, Feeling abnormal, Malaise, Nausea, Night sweats
Clinical narrative: Within 15 minutes from after being vaccinated felt nausea and that lasted for 30 minutes and disappeared; 2 days later started with chills; 2 days later started with having night sweat; still experiencing night sweat but not too often; feels weird from waking up sweaty in the morning; feels unwell since receiving the shot; This spontaneous case was reported by a consumer and describes the occurrence of NAUSEA (Within 15 minutes from after being vaccinated felt nausea and that lasted for 30 minutes and disappeared), CHILLS (2 days later started with chills), NIGHT SWEATS (2 days later started with having night sweat), NIGHT SWEATS (still experiencing night sweat but not too often) and FEELING ABNORMAL (feels weird from waking up sweaty in the morning) in a 45-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 032M20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     The patient's past medical history included No adverse event. Concomitant products included Oxycontin                                                      Chronic Pain, GABAPENTIN, ACETYLSALICYLIC ACID, CARISOPRODOL (SOMA CMPD), MONTELUKAST, TIOTROPIUM BROMIDE (SPIRIVA RESPIMAT), AZITHROMYCIN, MELOXICAM, Zyrtec                                                         Once daily, FLUTICASONE PROPIONATE (FLONASE ALLERGY RELIEF), CLOMIPRAMINE, PROPRANOLOL, Diclofenac topical gel                                         Once daily and ALPRAZOLAM (XANAX) for an unknown indication.    On 29-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced NAUSEA (Within 15 minutes from after being vaccinated felt nausea and that lasted for 30 minutes and disappeared), CHILLS (2 days later started with chills), NIGHT SWEATS (2 days later started with having night sweat), NIGHT SWEATS (still experiencing night sweat but not too often), FEELING ABNORMAL (feels weird from waking up sweaty in the morning) and MALAISE (feels unwell since receiving the shot). At the time of the report, CHILLS (2 days later started with chills), NIGHT SWEATS (2 days later started with having night sweat), NIGHT SWEATS (still experiencing night sweat but not too often), FEELING ABNORMAL (feels weird from waking up sweaty in the morning) and MALAISE (feels unwell since receiving the shot) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.
Age: 41.0
Sex: F
Vaccine: COVID19
Symptoms: Fatigue, Muscle spasms, Oropharyngeal pain, Pyrexia
Clinical narrative: sore throat; Muscle Spasms; Fever; fatigue; This spontaneous case was reported by a consumer and describes the occurrence of OROPHARYNGEAL PAIN (sore throat), MUSCLE SPASMS (Muscle Spasms), PYREXIA (Fever) and FATIGUE (fatigue) in a 41-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 020B21A and 036A21A) for COVID-19 vaccination.     No Medical History information was reported.   On 12-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 09-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 10-Apr-2021, the patient experienced MUSCLE SPASMS (Muscle Spasms), PYREXIA (Fever) and FATIGUE (fatigue). On 12-Apr-2021, the patient experienced OROPHARYNGEAL PAIN (sore throat). At the time of the report, OROPHARYNGEAL PAIN (sore throat), MUSCLE SPASMS (Muscle Spasms), PYREXIA (Fever) and FATIGUE (fatigue) outcome was unknown.            No concomitant medication details was reported. No treatment medication details was reported.  Action taken with mRNA-1273 in response to the events was not applicable.
Age: 65.0
Sex: F
Vaccine: COVID19
Symptoms: Chills, Diarrhoea, Fatigue, Hot flush, Malaise
Clinical narrative: hot flash; diarrhea; feeling sick; nausea; chills; vomiting; fatigue; This spontaneous case was reported by a consumer and describes the occurrence of HOT FLUSH (hot flash), DIARRHOEA (diarrhea), MALAISE (feeling sick), NAUSEA (nausea) and CHILLS (chills) in a 65-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 018BZ1A and 030A21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     Concomitant products included DILTIAZEM, METOPROLOL, METFORMIN, SIMVASTATIN, DIGOXIN, FUROSEMIDE (LASIX [FUROSEMIDE]), MAGNESIUM and SITAGLIPTIN (JANUVIA [SITAGLIPTIN]) for an unknown indication.   On 12-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 09-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 12-Mar-2021, the patient experienced FATIGUE (fatigue). On 09-Apr-2021, the patient experienced HOT FLUSH (hot flash), DIARRHOEA (diarrhea), MALAISE (feeling sick), NAUSEA (nausea), CHILLS (chills) and VOMITING (vomiting). The patient was treated with PARACETAMOL (TYLENOL) at an unspecified dose and frequency. On 02-Apr-2021, FATIGUE (fatigue) had resolved. At the time of the report, HOT FLUSH (hot flash), DIARRHOEA (diarrhea), MALAISE (feeling sick), NAUSEA (nausea), CHILLS (chills) and VOMITING (vomiting) outcome was unknown.            No treatment information was reported. Events are red arm, itchy arm.   This case was linked to US-MODERNATX, INC.-MOD-2021-073649 (E2B Linked Report).; Sender's Comments:  US-MODERNATX, INC.-MOD-2021-073649:
Age: 65.0
Sex: F
Vaccine: COVID19
Symptoms: Nausea, Vomiting
Clinical narrative: hot flash; diarrhea; feeling sick; nausea; chills; vomiting; fatigue; This spontaneous case was reported by a consumer and describes the occurrence of HOT FLUSH (hot flash), DIARRHOEA (diarrhea), MALAISE (feeling sick), NAUSEA (nausea) and CHILLS (chills) in a 65-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 018BZ1A and 030A21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     Concomitant products included DILTIAZEM, METOPROLOL, METFORMIN, SIMVASTATIN, DIGOXIN, FUROSEMIDE (LASIX [FUROSEMIDE]), MAGNESIUM and SITAGLIPTIN (JANUVIA [SITAGLIPTIN]) for an unknown indication.   On 12-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 09-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 12-Mar-2021, the patient experienced FATIGUE (fatigue). On 09-Apr-2021, the patient experienced HOT FLUSH (hot flash), DIARRHOEA (diarrhea), MALAISE (feeling sick), NAUSEA (nausea), CHILLS (chills) and VOMITING (vomiting). The patient was treated with PARACETAMOL (TYLENOL) at an unspecified dose and frequency. On 02-Apr-2021, FATIGUE (fatigue) had resolved. At the time of the report, HOT FLUSH (hot flash), DIARRHOEA (diarrhea), MALAISE (feeling sick), NAUSEA (nausea), CHILLS (chills) and VOMITING (vomiting) outcome was unknown.            No treatment information was reported. Events are red arm, itchy arm.   This case was linked to US-MODERNATX, INC.-MOD-2021-073649 (E2B Linked Report).; Sender's Comments:  US-MODERNATX, INC.-MOD-2021-073649:
Age: 61.0
Sex: F
Vaccine: COVID19
Symptoms: Mass, Pain in extremity, Rash pruritic, Skin discolouration, Swelling
Clinical narrative: left COVID arm; discolored itchy hot rash in the left arm; swelling in the left arm; lump in the left arm; discolored itchy hot rash in the left arm; soreness in the left arm; This spontaneous case was reported by a consumer and describes the occurrence of TYPE IV HYPERSENSITIVITY REACTION (left COVID arm), RASH PRURITIC (discolored itchy hot rash in the left arm), SWELLING (swelling in the left arm), MASS (lump in the left arm) and SKIN DISCOLOURATION (discolored itchy hot rash in the left arm) in a 61-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 025B21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.   On 05-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On an unknown date, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 06-Apr-2021, the patient experienced TYPE IV HYPERSENSITIVITY REACTION (left COVID arm), RASH PRURITIC (discolored itchy hot rash in the left arm), SWELLING (swelling in the left arm), MASS (lump in the left arm), SKIN DISCOLOURATION (discolored itchy hot rash in the left arm) and PAIN IN EXTREMITY (soreness in the left arm). At the time of the report, TYPE IV HYPERSENSITIVITY REACTION (left COVID arm), RASH PRURITIC (discolored itchy hot rash in the left arm), SWELLING (swelling in the left arm), MASS (lump in the left arm), SKIN DISCOLOURATION (discolored itchy hot rash in the left arm) and PAIN IN EXTREMITY (soreness in the left arm) outcome was unknown.            No concomitant medication details was reported. No treatment medication details was reported.  Action taken with mRNA-1273 in response to the events was not applicable.
Age: 61.0
Sex: F
Vaccine: COVID19
Symptoms: Type IV hypersensitivity reaction
Clinical narrative: left COVID arm; discolored itchy hot rash in the left arm; swelling in the left arm; lump in the left arm; discolored itchy hot rash in the left arm; soreness in the left arm; This spontaneous case was reported by a consumer and describes the occurrence of TYPE IV HYPERSENSITIVITY REACTION (left COVID arm), RASH PRURITIC (discolored itchy hot rash in the left arm), SWELLING (swelling in the left arm), MASS (lump in the left arm) and SKIN DISCOLOURATION (discolored itchy hot rash in the left arm) in a 61-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 025B21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.   On 05-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On an unknown date, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 06-Apr-2021, the patient experienced TYPE IV HYPERSENSITIVITY REACTION (left COVID arm), RASH PRURITIC (discolored itchy hot rash in the left arm), SWELLING (swelling in the left arm), MASS (lump in the left arm), SKIN DISCOLOURATION (discolored itchy hot rash in the left arm) and PAIN IN EXTREMITY (soreness in the left arm). At the time of the report, TYPE IV HYPERSENSITIVITY REACTION (left COVID arm), RASH PRURITIC (discolored itchy hot rash in the left arm), SWELLING (swelling in the left arm), MASS (lump in the left arm), SKIN DISCOLOURATION (discolored itchy hot rash in the left arm) and PAIN IN EXTREMITY (soreness in the left arm) outcome was unknown.            No concomitant medication details was reported. No treatment medication details was reported.  Action taken with mRNA-1273 in response to the events was not applicable.
Sex: F
Vaccine: COVID19
Symptoms: Eye pruritus, Feeling hot, Hordeolum
Clinical narrative: pimply growth on left upper eyelid up in the eyelash line; spots (a little longer) around and below left eye; feel burnish; This spontaneous case was reported by a consumer and describes the occurrence of HORDEOLUM (pimply growth on left upper eyelid up in the eyelash line), EYE PRURITUS (spots (a little longer) around and below left eye) and FEELING HOT (feel burnish) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 020B31A) for COVID-19 vaccination.     The patient's past medical history included No adverse event since an unknown date.    On 07-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 08-Apr-2021, the patient experienced HORDEOLUM (pimply growth on left upper eyelid up in the eyelash line), EYE PRURITUS (spots (a little longer) around and below left eye) and FEELING HOT (feel burnish). At the time of the report, HORDEOLUM (pimply growth on left upper eyelid up in the eyelash line), EYE PRURITUS (spots (a little longer) around and below left eye) and FEELING HOT (feel burnish) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Reporter did not allow further contact
Age: 63.0
Sex: F
Vaccine: COVID19
Symptoms: Dysstasia, Fatigue, Headache, Hyperhidrosis, Limb discomfort
Clinical narrative: felt like fainting; could not stand up; diaphoretic; sat on bathroom floor and could not get up; felt crushing feeling in head; overwhelming feeling of nausea; felt exhausted; discomfort in arm; This case was received via an unknown source (no reference has been entered for a health authority or license partner) on 12-Apr-2021 and was forwarded to Moderna on 12-Apr-2021.    This spontaneous case was reported by a consumer and describes the occurrence of LIMB DISCOMFORT (discomfort in arm), PRESYNCOPE (felt like fainting), DYSSTASIA (could not stand up), HYPERHIDROSIS (diaphoretic) and MOBILITY DECREASED (sat on bathroom floor and could not get up) in a 63-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 021B21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.   On 09-Apr-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 09-Apr-2021, the patient experienced LIMB DISCOMFORT (discomfort in arm). On 10-Apr-2021, the patient experienced PRESYNCOPE (felt like fainting), DYSSTASIA (could not stand up), HYPERHIDROSIS (diaphoretic), MOBILITY DECREASED (sat on bathroom floor and could not get up), HEADACHE (felt crushing feeling in head), NAUSEA (overwhelming feeling of nausea) and FATIGUE (felt exhausted). The patient was treated with PARACETAMOL (TYLENOL) at an unspecified dose and frequency. On 10-Apr-2021, PRESYNCOPE (felt like fainting), DYSSTASIA (could not stand up), HYPERHIDROSIS (diaphoretic), MOBILITY DECREASED (sat on bathroom floor and could not get up), HEADACHE (felt crushing feeling in head), NAUSEA (overwhelming feeling of nausea) and FATIGUE (felt exhausted) had resolved. At the time of the report, LIMB DISCOMFORT (discomfort in arm) outcome was unknown.            No concomitant medication details was reported. No treatment medication details was reported.  Action taken with mRNA-1273 in response to the events was not applicable.   Most recent FOLLOW-UP information incorporated above includes: On 27-Jul-2021: Nonsignificant FU added
Age: 63.0
Sex: F
Vaccine: COVID19
Symptoms: Mobility decreased, Nausea, Presyncope
Clinical narrative: felt like fainting; could not stand up; diaphoretic; sat on bathroom floor and could not get up; felt crushing feeling in head; overwhelming feeling of nausea; felt exhausted; discomfort in arm; This case was received via an unknown source (no reference has been entered for a health authority or license partner) on 12-Apr-2021 and was forwarded to Moderna on 12-Apr-2021.    This spontaneous case was reported by a consumer and describes the occurrence of LIMB DISCOMFORT (discomfort in arm), PRESYNCOPE (felt like fainting), DYSSTASIA (could not stand up), HYPERHIDROSIS (diaphoretic) and MOBILITY DECREASED (sat on bathroom floor and could not get up) in a 63-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 021B21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.   On 09-Apr-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 09-Apr-2021, the patient experienced LIMB DISCOMFORT (discomfort in arm). On 10-Apr-2021, the patient experienced PRESYNCOPE (felt like fainting), DYSSTASIA (could not stand up), HYPERHIDROSIS (diaphoretic), MOBILITY DECREASED (sat on bathroom floor and could not get up), HEADACHE (felt crushing feeling in head), NAUSEA (overwhelming feeling of nausea) and FATIGUE (felt exhausted). The patient was treated with PARACETAMOL (TYLENOL) at an unspecified dose and frequency. On 10-Apr-2021, PRESYNCOPE (felt like fainting), DYSSTASIA (could not stand up), HYPERHIDROSIS (diaphoretic), MOBILITY DECREASED (sat on bathroom floor and could not get up), HEADACHE (felt crushing feeling in head), NAUSEA (overwhelming feeling of nausea) and FATIGUE (felt exhausted) had resolved. At the time of the report, LIMB DISCOMFORT (discomfort in arm) outcome was unknown.            No concomitant medication details was reported. No treatment medication details was reported.  Action taken with mRNA-1273 in response to the events was not applicable.   Most recent FOLLOW-UP information incorporated above includes: On 27-Jul-2021: Nonsignificant FU added
Age: 35.0
Sex: M
Vaccine: COVID19
Symptoms: Pain in extremity
Clinical narrative: left arm was really painful; This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (left arm was really painful) in a 35-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 030M2A) for COVID-19 vaccination.     No Medical History information was reported.    On 13-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 13-Feb-2021, the patient experienced PAIN IN EXTREMITY (left arm was really painful). On 14-Feb-2021, PAIN IN EXTREMITY (left arm was really painful) had resolved. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No concomitant medications were reported.  No laboratory details were  provided.  No treatment medications were reported.    This case was linked to US-MODERNATX, INC.-MOD-2021-073656 (E2B Linked Report).   Most recent FOLLOW-UP information incorporated above includes: On 12-May-2021: NNI; Sender's Comments:  US-MODERNATX, INC.-MOD-2021-073656:
Age: 49.0
Sex: F
Vaccine: COVID19
Symptoms: Vaccination site bruising
Clinical narrative: purple burst/point in the injection site; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE BRUISING (purple burst/point in the injection site) in a 49-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 027B21A) for COVID-19 vaccination.     No Medical History information was reported.    On 08-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 09-Apr-2021, the patient experienced VACCINATION SITE BRUISING (purple burst/point in the injection site). At the time of the report, VACCINATION SITE BRUISING (purple burst/point in the injection site) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No concomitant medication details was reported. No treatment medication details was reported.
Sex: U
Vaccine: COVID19
Symptoms: Expired product administered
Clinical narrative: 75 patients received doses from vials that were past the beyond use date; One group of patients received vaccination within 12 hours of the beyond use date; One group of patients was received dose 12 hours past the beyond use date; certain patients received doses up to 6 days past the beyond use date; This spontaneous case was reported by a nurse and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (75 patients received doses from vials that were past the beyond use date), EXPIRED PRODUCT ADMINISTERED (One group of patients received vaccination within 12 hours of the beyond use date), EXPIRED PRODUCT ADMINISTERED (One group of patients was received dose 12 hours past the beyond use date) and EXPIRED PRODUCT ADMINISTERED (certain patients received doses up to 6 days past the beyond use date) 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 EXPIRED PRODUCT ADMINISTERED (75 patients received doses from vials that were past the beyond use date), EXPIRED PRODUCT ADMINISTERED (One group of patients received vaccination within 12 hours of the beyond use date), EXPIRED PRODUCT ADMINISTERED (One group of patients was received dose 12 hours past the beyond use date) and EXPIRED PRODUCT ADMINISTERED (certain patients received doses up to 6 days past the beyond use date). At the time of the report, EXPIRED PRODUCT ADMINISTERED (75 patients received doses from vials that were past the beyond use date), EXPIRED PRODUCT ADMINISTERED (One group of patients received vaccination within 12 hours of the beyond use date), EXPIRED PRODUCT ADMINISTERED (One group of patients was received dose 12 hours past the beyond use date) and EXPIRED PRODUCT ADMINISTERED (certain patients received doses up to 6 days past the beyond use date) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   Most recent FOLLOW-UP information incorporated above includes: On 09-Apr-2021: No specific follow-up information recorded.
Age: 47.0
Sex: M
Vaccine: COVID19
Symptoms: Body temperature, Chills, Diarrhoea, Hyperhidrosis, Illness
Clinical narrative: mightily, described as being sick / deathly ill since receiving the series; Both arms are described to be essentially useless due to the symptom; shakes; sweats; migraine headache; diarrhea; chills; fever / modest fever of 99.5 degrees; nausea; his right arm started hurting; This spontaneous case was reported by a consumer and describes the occurrence of ILLNESS (mightily, described as being sick / deathly ill since receiving the series), MOBILITY DECREASED (Both arms are described to be essentially useless due to the symptom), TREMOR (shakes), HYPERHIDROSIS (sweats) and MIGRAINE (migraine headache) 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 Migraine headache.   On 11-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. On an unknown date, the patient experienced ILLNESS (mightily, described as being sick / deathly ill since receiving the series), MOBILITY DECREASED (Both arms are described to be essentially useless due to the symptom), TREMOR (shakes), HYPERHIDROSIS (sweats), MIGRAINE (migraine headache), DIARRHEA (diarrhea), CHILLS (chills), PYREXIA (fever / modest fever of 99.5 degrees), NAUSEA (nausea) and MYALGIA (his right arm started hurting). At the time of the report, ILLNESS (mightily, described as being sick / deathly ill since receiving the series), MOBILITY DECREASED (Both arms are described to be essentially useless due to the symptom), TREMOR (shakes), HYPERHIDROSIS (sweats), MIGRAINE (migraine headache), DIARRHEA (diarrhea), CHILLS (chills), PYREXIA (fever / modest fever of 99.5 degrees), NAUSEA (nausea) and MYALGIA (his right arm started hurting) outcome was unknown. Not Provided    DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, Body temperature: 99.5 (normal) 99.5.         Treatment He applied ice to his hurting arm and took Motrin after the first dose. No concomitant medication details was reported. No treatment medication details was reported.  Action taken with mRNA-1273 in response to the events was not applicable.     This case was linked to US-MODERNATX, INC.-MOD-2021-073635 (E2B Linked Report).; Sender's Comments:  US-MODERNATX, INC.-MOD-2021-073635:1st dose case