chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 75.0
Sex: F
Vaccine: COVID19
Symptoms: Cough, Headache, Influenza like illness, Nausea, Sneezing
Clinical narrative: flu like symptoms; sneezing; coughing; nausea; vomiting; headache; This spontaneous case was reported by a consumer and describes the occurrence of INFLUENZA LIKE ILLNESS (flu like symptoms), SNEEZING (sneezing), COUGH (coughing), NAUSEA (nausea) and VOMITING (vomiting) in a 75-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 012A21A and C4112DA) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     no medical history was provided by the reporter.  Concomitant products included ATORVASTATIN CALCIUM (LIPITOR), AMLODIPINE BESILATE, HYDROCHLOROTHIAZIDE, OLMESARTAN MEDOXOMIL (TRIBENZOR), UBIDECARENONE (COQ10 [UBIDECARENONE]) and CLOPIDOGREL BISULFATE (PLAVIX) for an unknown indication.   On 30-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 27-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On an unknown date, the patient experienced INFLUENZA LIKE ILLNESS (flu like symptoms), SNEEZING (sneezing), COUGH (coughing), NAUSEA (nausea), VOMITING (vomiting) and HEADACHE (headache). At the time of the report, INFLUENZA LIKE ILLNESS (flu like symptoms), SNEEZING (sneezing), COUGH (coughing), NAUSEA (nausea), VOMITING (vomiting) and HEADACHE (headache) outcome was unknown.            patient reported having flu like symptoms 3-4mos after receiving the second dose. No Treatment medication were provided concomitant medication include symbiotic 365
Age: 75.0
Sex: F
Vaccine: COVID19
Symptoms: Vomiting
Clinical narrative: flu like symptoms; sneezing; coughing; nausea; vomiting; headache; This spontaneous case was reported by a consumer and describes the occurrence of INFLUENZA LIKE ILLNESS (flu like symptoms), SNEEZING (sneezing), COUGH (coughing), NAUSEA (nausea) and VOMITING (vomiting) in a 75-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 012A21A and C4112DA) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     no medical history was provided by the reporter.  Concomitant products included ATORVASTATIN CALCIUM (LIPITOR), AMLODIPINE BESILATE, HYDROCHLOROTHIAZIDE, OLMESARTAN MEDOXOMIL (TRIBENZOR), UBIDECARENONE (COQ10 [UBIDECARENONE]) and CLOPIDOGREL BISULFATE (PLAVIX) for an unknown indication.   On 30-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 27-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On an unknown date, the patient experienced INFLUENZA LIKE ILLNESS (flu like symptoms), SNEEZING (sneezing), COUGH (coughing), NAUSEA (nausea), VOMITING (vomiting) and HEADACHE (headache). At the time of the report, INFLUENZA LIKE ILLNESS (flu like symptoms), SNEEZING (sneezing), COUGH (coughing), NAUSEA (nausea), VOMITING (vomiting) and HEADACHE (headache) outcome was unknown.            patient reported having flu like symptoms 3-4mos after receiving the second dose. No Treatment medication were provided concomitant medication include symbiotic 365
Sex: F
Vaccine: COVID19
Symptoms: Erythema, Peripheral swelling, Rash
Clinical narrative: Swelling on her feet; Redness; Rashes on both of her ankles; This spontaneous case was reported by a consumer and describes the occurrence of PERIPHERAL SWELLING (Swelling on her feet), ERYTHEMA (Redness) and RASH (Rashes on both of her ankles) in a 79-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 024M20A) for COVID-19 vaccination.     Concurrent medical conditions included Blood pressure abnormal. Concomitant products included AMLODIPINE for Blood pressure management, VITAMINS NOS for an unknown indication.    On 12-Feb-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced PERIPHERAL SWELLING (Swelling on her feet), ERYTHEMA (Redness) and RASH (Rashes on both of her ankles). The patient was treated with TRIAMCINOLONE ACETONIDE on 27-May-2021 for Rash, at an unspecified dose and frequency. At the time of the report, PERIPHERAL SWELLING (Swelling on her feet) and RASH (Rashes on both of her ankles) had not resolved and ERYTHEMA (Redness) had resolved.            Patient reported that she noticed her symptoms in March or April after the second dose. Patient stated that she would be going to be see Dermatologist and Hematologist doctor as a follow up.Patient also stated that her provider recently increase the dosage in January from amlodipine 2.5 mg to 10 mg.    This case was linked to MOD-2021-280663 (Patient Link).
Age: 78.0
Sex: F
Vaccine: COVID19
Symptoms: Vaccination site pain
Clinical narrative: experience a slight tenderness around site of the injection; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE PAIN (experience a slight tenderness around site of the injection) in a 79-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 013L20A) for COVID-19 vaccination.     No medical history information was reported.  Concomitant products included AMLODIPINE for Blood pressure, VITAMINS NOS for an unknown indication. On 15-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced VACCINATION SITE PAIN (experience a slight tenderness around site of the injection). At the time of the report, VACCINATION SITE PAIN (experience a slight tenderness around site of the injection) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown. Treatment information was not provided.   This case was linked to MOD-2021-280653 (Patient Link).
Age: 67.0
Sex: F
Vaccine: COVID19
Symptoms: Vaccination site erythema, Vaccination site pain, Vaccination site warmth
Clinical narrative: Had fever in it; Her arm got a baseball sized red spot at the injection site; Felt like a wasp was stinging it; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE WARMTH (Had fever in it), VACCINATION SITE ERYTHEMA (Her arm got a baseball sized red spot at the injection site) and VACCINATION SITE PAIN (Felt like a wasp was stinging it) in a 67-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 047B21A) for COVID-19 vaccination.     No Medical History information was reported.    On 27-Jul-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced VACCINATION SITE WARMTH (Had fever in it), VACCINATION SITE ERYTHEMA (Her arm got a baseball sized red spot at the injection site) and VACCINATION SITE PAIN (Felt like a wasp was stinging it). At the time of the report, VACCINATION SITE WARMTH (Had fever in it), VACCINATION SITE ERYTHEMA (Her arm got a baseball sized red spot at the injection site) and VACCINATION SITE PAIN (Felt like a wasp was stinging it) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No concomitant medications were reported by the reporter. No treatment information was provided by the reporter.
Age: 47.0
Sex: M
Vaccine: COVID19
Symptoms: Chills, Myalgia, Pyrexia
Clinical narrative: He had fever/fever was 103-104/Fever came down after 5 to 6 hours but came back again/As of now, he still has fever; He had chills on friday; He also had body aches; This spontaneous case was reported by a consumer and describes the occurrence of PYREXIA (He had fever/fever was 103-104/Fever came down after 5 to 6 hours but came back again/As of now, he still has fever), CHILLS (He had chills on friday) and MYALGIA (He also had body aches) in a 47-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 003B21A) for COVID-19 vaccination.     No Medical History information was reported.  Concomitant products included QUINAPRIL, AMLODIPINE, METOPROLOL, ATORVASTATIN, METFORMIN and OMEPRAZOLE for an unknown indication.    On 03-Aug-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 06-Aug-2021, the patient experienced PYREXIA (He had fever/fever was 103-104/Fever came down after 5 to 6 hours but came back again/As of now, he still has fever), CHILLS (He had chills on friday) and MYALGIA (He also had body aches). The patient was treated with PARACETAMOL (TYLENOL) for Adverse event, at an unspecified dose and frequency and IBUPROFEN for Adverse event, at an unspecified dose and frequency. At the time of the report, PYREXIA (He had fever/fever was 103-104/Fever came down after 5 to 6 hours but came back again/As of now, he still has fever) had not resolved and CHILLS (He had chills on friday) and MYALGIA (He also had body aches) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 07-Aug-2021, Pyrexia: 103-104 (High) 103-104.     The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.
Sex: U
Vaccine: COVID19
Symptoms: Vaccination complication
Clinical narrative: Side effects 24hr after; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION COMPLICATION (Side effects 24hr after) in a  patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On an unknown date, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced VACCINATION COMPLICATION (Side effects 24hr after). At the time of the report, VACCINATION COMPLICATION (Side effects 24hr after) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No concomitant medication were provided. No treatment details were provided
Sex: F
Vaccine: COVID19
Symptoms: Hypoaesthesia, Vaccination site pain
Clinical narrative: Fuzzy sensation in the arm; Pain at the site of the injection; This spontaneous case was reported by a consumer and describes the occurrence of HYPOAESTHESIA (Fuzzy sensation in the arm) and VACCINATION SITE PAIN (Pain at the site of the injection) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 091D21A) for COVID-19 vaccination.     No Medical History information was reported.    On 01-Aug-2021, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 01-Aug-2021, the patient experienced VACCINATION SITE PAIN (Pain at the site of the injection). On 07-Aug-2021, the patient experienced HYPOAESTHESIA (Fuzzy sensation in the arm). On 02-Aug-2021, VACCINATION SITE PAIN (Pain at the site of the injection) had resolved. At the time of the report, HYPOAESTHESIA (Fuzzy sensation in the arm) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No concomitant medications or treatment details were reported.
Age: 75.0
Sex: F
Vaccine: COVID19
Symptoms: Injection site erythema, Pruritus
Clinical narrative: Reddened area was "twice the size" of the first reaction; It was "more itchy; This case was received via an unknown source (no reference has been entered for a health authority or license partner) on 09-Aug-2021 and was forwarded to Moderna on 09-Aug-2021.    This spontaneous case was reported by a consumer and describes the occurrence of INJECTION SITE ERYTHEMA (Reddened area was "twice the size" of the first reaction) and PRURITUS (It was "more itchy) in a 75-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.   In April 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 INJECTION SITE ERYTHEMA (Reddened area was "twice the size" of the first reaction) and PRURITUS (It was "more itchy). At the time of the report, INJECTION SITE ERYTHEMA (Reddened area was "twice the size" of the first reaction) and PRURITUS (It was "more itchy) had resolved. The concomitant medications were not reported. The treatment information was not provided.
Sex: U
Vaccine: COVID19
Symptoms: Pain in extremity
Clinical narrative: pain under the arm after receiving the vaccine; This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (pain under the arm after receiving the vaccine) in a patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On an unknown date, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced PAIN IN EXTREMITY (pain under the arm after receiving the vaccine). At the time of the report, PAIN IN EXTREMITY (pain under the arm after receiving the vaccine) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No concomitant medications were reported. No treatment medications were reported.
Sex: U
Vaccine: COVID19
Symptoms: Asthenia, Headache, Hot flush, Nausea, Vomiting
Clinical narrative: Weakness; Hot flashes; Nauseous; Vomiting; Headache; Based on the current case data, this case has been classified as invalid. This spontaneous case was reported by a consumer and describes the occurrence of ASTHENIA (Weakness), HOT FLUSH (Hot flashes), NAUSEA (Nauseous), VOMITING (Vomiting) and HEADACHE (Headache) in a patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     Concurrent medical conditions included Immune system disorder (NOS) (compromised).    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 ASTHENIA (Weakness), HOT FLUSH (Hot flashes), NAUSEA (Nauseous), VOMITING (Vomiting) and HEADACHE (Headache). At the time of the report, ASTHENIA (Weakness), HOT FLUSH (Hot flashes), NAUSEA (Nauseous), VOMITING (Vomiting) and HEADACHE (Headache) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No concomitant medications were reported.  No treatment information was provided.
Sex: F
Vaccine: COVID19
Symptoms: Myalgia
Clinical narrative: Everything hurt; This spontaneous case was reported by a consumer and describes the occurrence of MYALGIA (Everything hurt) in a 75-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 046A21A) for COVID-19 vaccination.     Concurrent medical conditions included Fibromyalgia (so she usually has aches and pains). Concomitant products included HYDROCODONE, LORAZEPAM, VITIS VINIFERA SEED (GRAPE SEED EXTRACT HS), IODINE, VITAMINS NOS, MAGNESIUM and PROBIOTICS NOS 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 29-Mar-2021, the patient experienced MYALGIA (Everything hurt). At the time of the report, MYALGIA (Everything hurt) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Other concomitant medication included  something for macular degeneration.  No treatment information was provided by the reporter.    This case was linked to MOD-2021-280740 (Patient Link).
Sex: U
Vaccine: COVID19
Symptoms: COVID-19
Clinical narrative: 4 breakthrough cases of Covid 19; This case was received via an unknown source (no reference has been entered for a health authority or license partner) on 09-Aug-2021 and was forwarded to Moderna on 09-Aug-2021.    Based on the current case data, this case has been classified as invalid. This spontaneous case was reported by a physician and describes the occurrence of COVID-19 (4 breakthrough cases of Covid 19) in a patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced COVID-19 (4 breakthrough cases of Covid 19). At the time of the report, COVID-19 (4 breakthrough cases of Covid 19) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant medication was reported  No treatment medication was reported
Age: 72.0
Sex: M
Vaccine: COVID19
Symptoms: Myalgia
Clinical narrative: a little sore in the arm after the vaccine and that's it; This spontaneous case was reported by a consumer and describes the occurrence of MYALGIA (a little sore in the arm after the vaccine and that's it) in a 72-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 011M20A) for COVID-19 vaccination.     The patient's past medical history included Quintuple coronary bypass in 1993 and Defibrillator/pacemaker insertion in 2006. Concomitant products included ISOSORBIDE, HYDROCHLOROTHIAZIDE, PANTOPRAZOLE, ESCITALOPRAM, RANOLAZINE (RANEXA), ACETYLSALICYLIC ACID (ASPIRIN 81), CLOPIDOGREL, SIMVASTATIN, TAMSULOSIN HYDROCHLORIDE (TAMSULIN), TRAZODONE, FINASTERIDE and LOSARTAN for an unknown indication.    On 15-Feb-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 MYALGIA (a little sore in the arm after the vaccine and that's it). At the time of the report, MYALGIA (a little sore in the arm after the vaccine and that's it) outcome was unknown. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No treatment was provided by the reporter.   This case was linked to MOD-2021-274692 (Patient Link).
Age: 76.0
Sex: F
Vaccine: COVID19
Symptoms: Arthralgia, Headache, Musculoskeletal stiffness, Neuralgia
Clinical narrative: extreme joint (or nerve) pain in sacro/iliac,neck & shoulders; very stiff neck on left side (the side injection was given); extreme joint (or nerve) pain in sacro/iliac,neck & shoulders; Slight headache; This spontaneous case was reported by a consumer and describes the occurrence of NEURALGIA (extreme joint (or nerve) pain in sacro/iliac,neck & shoulders), MUSCULOSKELETAL STIFFNESS (very stiff neck on left side (the side injection was given)), ARTHRALGIA (extreme joint (or nerve) pain in sacro/iliac,neck & shoulders) and HEADACHE (Slight headache) in a 76-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 002A21A) for COVID-19 vaccination.     Concurrent medical conditions included Allergy to chemicals (sulfites), Gluten intolerance, Galactose intolerance, Fructose intolerance and Drug allergy (Sulfa). Concomitant products included ESTROGENS CONJUGATED (PREMARIN) for Hormone replacement therapy, MULTIVITAMIN [VITAMINS NOS] and VITAMIN D [VITAMIN D NOS] for Supplementation therapy.    On 27-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 27-Feb-2021, the patient experienced NEURALGIA (extreme joint (or nerve) pain in sacro/iliac,neck & shoulders), MUSCULOSKELETAL STIFFNESS (very stiff neck on left side (the side injection was given)), ARTHRALGIA (extreme joint (or nerve) pain in sacro/iliac,neck & shoulders) and HEADACHE (Slight headache). On 01-Mar-2021, NEURALGIA (extreme joint (or nerve) pain in sacro/iliac,neck & shoulders), MUSCULOSKELETAL STIFFNESS (very stiff neck on left side (the side injection was given)), ARTHRALGIA (extreme joint (or nerve) pain in sacro/iliac,neck & shoulders) and HEADACHE (Slight headache) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Concomitant medication including Acidophilous taken orally as general supplement and Lutein taken orally as preventative was reported.  No treatment information was reported.   This case was linked to MOD-2021-220687 (Patient Link).
Age: 45.0
Sex: F
Vaccine: COVID19
Symptoms: Muscle spasms, Pain in extremity
Clinical narrative: pain on her right arm and right leg/both her hands feel like painful.; both her hands feel like cramped; This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (pain on her right arm and right leg/both her hands feel like painful.) and MUSCLE SPASMS (both her hands feel like cramped) in a 45-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On 23-Jul-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 23-Jul-2021, the patient experienced PAIN IN EXTREMITY (pain on her right arm and right leg/both her hands feel like painful.) and MUSCLE SPASMS (both her hands feel like cramped). At the time of the report, PAIN IN EXTREMITY (pain on her right arm and right leg/both her hands feel like painful.) and MUSCLE SPASMS (both her hands feel like cramped) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No concomitant medication provided by the patient No treatment was received by the patient
Age: 72.0
Sex: F
Vaccine: COVID19
Symptoms: Abdominal discomfort, Cough, Fatigue, Feeling abnormal, Headache
Clinical narrative: sniffles; felt like she was coming down with something; dry cough in morning and evening; muscle ache; occasional headache; feels like she is feeling her liver; 3 days ago had fever at around 99.6F; felt a little tired/fatigue; This spontaneous case was reported by a consumer and describes the occurrence of RHINORRHOEA (sniffles), FEELING ABNORMAL (felt like she was coming down with something), ABDOMINAL DISCOMFORT (feels like she is feeling her liver), COUGH (dry cough in morning and evening) and FATIGUE (felt a little tired/fatigue) in a 72-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 001B21A and 016M20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     Concurrent medical conditions included Allergic to cats (allergic to cat dander.), Nickel sensitivity (allergic to nickel.), Pollen allergy, Hypertension and Thyroid disorder. Concomitant products included THYROID (ARMOUR THYROID), MULTIVITAMINS [VITAMINS NOS], MAGNESIUM and COLLAGEN for an unknown indication, HYDROCHLOROTHIAZIDE (HYDROCHLOROTHIAZIDE ORION).   On 08-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 08-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 09-Mar-2021, the patient experienced FATIGUE (felt a little tired/fatigue). On 04-Aug-2021, the patient experienced PYREXIA (3 days ago had fever at around 99.6F). On 07-Aug-2021, the patient experienced ABDOMINAL DISCOMFORT (feels like she is feeling her liver) and HEADACHE (occasional headache). On an unknown date, the patient experienced RHINORRHOEA (sniffles), FEELING ABNORMAL (felt like she was coming down with something), COUGH (dry cough in morning and evening) and MYALGIA (muscle ache). At the time of the report, RHINORRHOEA (sniffles) had resolved and FEELING ABNORMAL (felt like she was coming down with something), ABDOMINAL DISCOMFORT (feels like she is feeling her liver), COUGH (dry cough in morning and evening), FATIGUE (felt a little tired/fatigue), HEADACHE (occasional headache), MYALGIA (muscle ache) and PYREXIA (3 days ago had fever at around 99.6F) had not resolved.            No treatment medication reported.   Most recent FOLLOW-UP information incorporated above includes: On 11-Oct-2021: Follow-up received contains no new information.
Age: 72.0
Sex: F
Vaccine: COVID19
Symptoms: Myalgia, Pyrexia, Rhinorrhoea
Clinical narrative: sniffles; felt like she was coming down with something; dry cough in morning and evening; muscle ache; occasional headache; feels like she is feeling her liver; 3 days ago had fever at around 99.6F; felt a little tired/fatigue; This spontaneous case was reported by a consumer and describes the occurrence of RHINORRHOEA (sniffles), FEELING ABNORMAL (felt like she was coming down with something), ABDOMINAL DISCOMFORT (feels like she is feeling her liver), COUGH (dry cough in morning and evening) and FATIGUE (felt a little tired/fatigue) in a 72-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 001B21A and 016M20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     Concurrent medical conditions included Allergic to cats (allergic to cat dander.), Nickel sensitivity (allergic to nickel.), Pollen allergy, Hypertension and Thyroid disorder. Concomitant products included THYROID (ARMOUR THYROID), MULTIVITAMINS [VITAMINS NOS], MAGNESIUM and COLLAGEN for an unknown indication, HYDROCHLOROTHIAZIDE (HYDROCHLOROTHIAZIDE ORION).   On 08-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 08-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 09-Mar-2021, the patient experienced FATIGUE (felt a little tired/fatigue). On 04-Aug-2021, the patient experienced PYREXIA (3 days ago had fever at around 99.6F). On 07-Aug-2021, the patient experienced ABDOMINAL DISCOMFORT (feels like she is feeling her liver) and HEADACHE (occasional headache). On an unknown date, the patient experienced RHINORRHOEA (sniffles), FEELING ABNORMAL (felt like she was coming down with something), COUGH (dry cough in morning and evening) and MYALGIA (muscle ache). At the time of the report, RHINORRHOEA (sniffles) had resolved and FEELING ABNORMAL (felt like she was coming down with something), ABDOMINAL DISCOMFORT (feels like she is feeling her liver), COUGH (dry cough in morning and evening), FATIGUE (felt a little tired/fatigue), HEADACHE (occasional headache), MYALGIA (muscle ache) and PYREXIA (3 days ago had fever at around 99.6F) had not resolved.            No treatment medication reported.   Most recent FOLLOW-UP information incorporated above includes: On 11-Oct-2021: Follow-up received contains no new information.
Sex: U
Vaccine: COVID19
Symptoms: Ageusia, Anosmia, Fatigue, Feeling abnormal, Headache
Clinical narrative: Smell/taste; Smell/taste; Foggy brain; Long-haul symptoms that re-surfaced; Headaches; Exhaustion reemerged soon after my second shot; This spontaneous case was reported by a consumer and describes the occurrence of ANOSMIA (Smell/taste), AGEUSIA (Smell/taste), FEELING ABNORMAL (Foggy brain), SYMPTOM RECURRENCE (Long-haul symptoms that re-surfaced) and HEADACHE (Headaches) in a  patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     The patient's past medical history included COVID-19 (Had Covid in December or January).   On an unknown date, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient experienced ANOSMIA (Smell/taste), AGEUSIA (Smell/taste), FEELING ABNORMAL (Foggy brain), SYMPTOM RECURRENCE (Long-haul symptoms that re-surfaced), HEADACHE (Headaches) and FATIGUE (Exhaustion reemerged soon after my second shot). At the time of the report, ANOSMIA (Smell/taste), AGEUSIA (Smell/taste), FEELING ABNORMAL (Foggy brain), SYMPTOM RECURRENCE (Long-haul symptoms that re-surfaced), HEADACHE (Headaches) and FATIGUE (Exhaustion reemerged soon after my second shot) outcome was unknown.            No concomitant medication was reported. No treatment medication was reported.
Sex: U
Vaccine: COVID19
Symptoms: Symptom recurrence
Clinical narrative: Smell/taste; Smell/taste; Foggy brain; Long-haul symptoms that re-surfaced; Headaches; Exhaustion reemerged soon after my second shot; This spontaneous case was reported by a consumer and describes the occurrence of ANOSMIA (Smell/taste), AGEUSIA (Smell/taste), FEELING ABNORMAL (Foggy brain), SYMPTOM RECURRENCE (Long-haul symptoms that re-surfaced) and HEADACHE (Headaches) in a  patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     The patient's past medical history included COVID-19 (Had Covid in December or January).   On an unknown date, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient experienced ANOSMIA (Smell/taste), AGEUSIA (Smell/taste), FEELING ABNORMAL (Foggy brain), SYMPTOM RECURRENCE (Long-haul symptoms that re-surfaced), HEADACHE (Headaches) and FATIGUE (Exhaustion reemerged soon after my second shot). At the time of the report, ANOSMIA (Smell/taste), AGEUSIA (Smell/taste), FEELING ABNORMAL (Foggy brain), SYMPTOM RECURRENCE (Long-haul symptoms that re-surfaced), HEADACHE (Headaches) and FATIGUE (Exhaustion reemerged soon after my second shot) outcome was unknown.            No concomitant medication was reported. No treatment medication was reported.
Age: 52.0
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, Chills, Cough, Headache, Myalgia
Clinical narrative: Coughing; Sore throat; Body aching; Chills; Fever on and off; Headache since last two day and no headache today; Tested positive with COVID with home test; This spontaneous case was reported by a consumer and describes the occurrence of COVID-19 (Tested positive with COVID with home test), COUGH (Coughing), OROPHARYNGEAL PAIN (Sore throat), MYALGIA (Body aching) and CHILLS (Chills) in a 52-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 040C21) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No medical history information was reported.  Concomitant products included OLMESARTAN and AMLODIPINE for an unknown indication.    On 06-Aug-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 09-Aug-2021, the patient experienced COVID-19 (Tested positive with COVID with home test). On an unknown date, the patient experienced COUGH (Coughing), OROPHARYNGEAL PAIN (Sore throat), MYALGIA (Body aching), CHILLS (Chills), PYREXIA (Fever on and off) and HEADACHE (Headache since last two day and no headache today). At the time of the report, COVID-19 (Tested positive with COVID with home test), COUGH (Coughing), OROPHARYNGEAL PAIN (Sore throat), MYALGIA (Body aching), CHILLS (Chills) and PYREXIA (Fever on and off) outcome was unknown and HEADACHE (Headache since last two day and no headache today) had resolved.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 09-Aug-2021, SARS-CoV-2 test: positive (Positive) Positive.     The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Treatment information was not provided. Patient was tested negative twice prior to getting the 1st dose.   Reporter did not allow further contact
Age: 52.0
Sex: F
Vaccine: COVID19
Symptoms: Oropharyngeal pain, Pyrexia, SARS-CoV-2 test
Clinical narrative: Coughing; Sore throat; Body aching; Chills; Fever on and off; Headache since last two day and no headache today; Tested positive with COVID with home test; This spontaneous case was reported by a consumer and describes the occurrence of COVID-19 (Tested positive with COVID with home test), COUGH (Coughing), OROPHARYNGEAL PAIN (Sore throat), MYALGIA (Body aching) and CHILLS (Chills) in a 52-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 040C21) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No medical history information was reported.  Concomitant products included OLMESARTAN and AMLODIPINE for an unknown indication.    On 06-Aug-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 09-Aug-2021, the patient experienced COVID-19 (Tested positive with COVID with home test). On an unknown date, the patient experienced COUGH (Coughing), OROPHARYNGEAL PAIN (Sore throat), MYALGIA (Body aching), CHILLS (Chills), PYREXIA (Fever on and off) and HEADACHE (Headache since last two day and no headache today). At the time of the report, COVID-19 (Tested positive with COVID with home test), COUGH (Coughing), OROPHARYNGEAL PAIN (Sore throat), MYALGIA (Body aching), CHILLS (Chills) and PYREXIA (Fever on and off) outcome was unknown and HEADACHE (Headache since last two day and no headache today) had resolved.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 09-Aug-2021, SARS-CoV-2 test: positive (Positive) Positive.     The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Treatment information was not provided. Patient was tested negative twice prior to getting the 1st dose.   Reporter did not allow further contact
Sex: U
Vaccine: COVID19
Symptoms: Vaccination site erythema, Vaccination site swelling
Clinical narrative: Today the site for the first time decided to swell; Today the site fir the first time decided to get red; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE SWELLING (Today the site for the first time decided to swell) and VACCINATION SITE ERYTHEMA (Today the site fir the first time decided to get red) in a patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced VACCINATION SITE SWELLING (Today the site for the first time decided to swell) and VACCINATION SITE ERYTHEMA (Today the site fir the first time decided to get red). At the time of the report, VACCINATION SITE SWELLING (Today the site for the first time decided to swell) and VACCINATION SITE ERYTHEMA (Today the site fir the first time decided to get red) had not 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.
Age: 12.0
Sex: F
Vaccine: COVID19
Symptoms: Product administered to patient of inappropriate age
Clinical narrative: First dose administered to 12 year old; This spontaneous case was reported by a nurse and describes the occurrence of PRODUCT ADMINISTERED TO PATIENT OF INAPPROPRIATE AGE (First dose administered to 12 year old) in a 12-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 003C21A) for COVID-19 vaccination.     No Medical History information was reported.    On 10-Jul-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 10-Jul-2021, the patient experienced PRODUCT ADMINISTERED TO PATIENT OF INAPPROPRIATE AGE (First dose administered to 12 year old). On 10-Jul-2021, PRODUCT ADMINISTERED TO PATIENT OF INAPPROPRIATE AGE (First dose administered to 12 year old) had resolved.        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.   No concomitant medication reported. No treatment information was provided.
Sex: F
Vaccine: COVID19
Symptoms: Chronic fatigue syndrome, Feeling abnormal, Vaccination site mass, Vaccination site pain
Clinical narrative: Chronic Fatigue Syndrome; I do not feel like I am alive; Lump on the injection site; Sore injection site; This spontaneous case was reported by a consumer and describes the occurrence of CHRONIC FATIGUE SYNDROME (Chronic Fatigue Syndrome), FEELING ABNORMAL (I do not feel like I am alive), VACCINATION SITE MASS (Lump on the injection site) and VACCINATION SITE PAIN (Sore injection site) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.   In May 2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. In June 2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. In June 2021, the patient experienced CHRONIC FATIGUE SYNDROME (Chronic Fatigue Syndrome), FEELING ABNORMAL (I do not feel like I am alive), VACCINATION SITE MASS (Lump on the injection site) and VACCINATION SITE PAIN (Sore injection site). In June 2021, VACCINATION SITE MASS (Lump on the injection site) and VACCINATION SITE PAIN (Sore injection site) had resolved. At the time of the report, CHRONIC FATIGUE SYNDROME (Chronic Fatigue Syndrome) and FEELING ABNORMAL (I do not feel like I am alive) outcome was unknown.            No concomitant medications reported. Treatment information not reported.   Reporter did not allow further contact
Age: 36.0
Sex: F
Vaccine: COVID19
Symptoms: Dizziness, Headache
Clinical narrative: Dizziness; headaches; This spontaneous case was reported by a consumer and describes the occurrence of DIZZINESS (Dizziness) and HEADACHE (headaches) in a 36-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On 30-Jul-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 06-Aug-2021, the patient experienced DIZZINESS (Dizziness) and HEADACHE (headaches). At the time of the report, DIZZINESS (Dizziness) and HEADACHE (headaches) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No concomitant medications were reported.  No treatment medications were reported.   Most recent FOLLOW-UP information incorporated above includes: On 01-Oct-2021: Follow-up received contains additional no new information
Sex: F
Vaccine: COVID19
Symptoms: Incorrect route of product administration, Wrong technique in product usage process
Clinical narrative: This spontaneous case was reported by a pharmacist and describes the occurrence of WRONG TECHNIQUE IN PRODUCT USAGE PROCESS (the needle was the wrong size (26G)) and INCORRECT ROUTE OF PRODUCT ADMINISTRATION (vaccine was administered intradermally) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. Unknown and Unknown) 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) (Intradermal) 1 dosage form. On an unknown date, received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient experienced WRONG TECHNIQUE IN PRODUCT USAGE PROCESS (the needle was the wrong size (26G)) and INCORRECT ROUTE OF PRODUCT ADMINISTRATION (vaccine was administered intradermally). At the time of the report, WRONG TECHNIQUE IN PRODUCT USAGE PROCESS (the needle was the wrong size (26G)) and INCORRECT ROUTE OF PRODUCT ADMINISTRATION (vaccine was administered intradermally) had resolved. For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments. Concomitant medications were not provided. Treatment information was not provided by reporter.
Sex: M
Vaccine: COVID19
Symptoms: Headache, Nausea
Clinical narrative: Headache; Nausea; This spontaneous case was reported by a consumer and describes the occurrence of HEADACHE (Headache) and NAUSEA (Nausea) in a male patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 25-Jul-2021, the patient experienced HEADACHE (Headache) and NAUSEA (Nausea). At the time of the report, HEADACHE (Headache) and NAUSEA (Nausea) had not resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No concomitant medication reported. No treatment information was provided.
Age: 32.0
Sex: F
Vaccine: COVID19
Symptoms: Pruritus, Urticaria
Clinical narrative: Hives breakout on arms and legs (both sides); Itchiness; This spontaneous case was reported by a consumer and describes the occurrence of URTICARIA (Hives breakout on arms and legs (both sides)) and PRURITUS (Itchiness) in a 32-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 088D21A) for COVID-19 vaccination.     Concurrent medical conditions included Fruit allergy (Allergies to Grapes), Drug allergy (Propofol caused tremors) and Seasonal allergy (Season allergies).    On 03-Aug-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 05-Aug-2021, the patient experienced URTICARIA (Hives breakout on arms and legs (both sides)) and PRURITUS (Itchiness). At the time of the report, URTICARIA (Hives breakout on arms and legs (both sides)) and PRURITUS (Itchiness) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No concomitant medication reported. No treatment information was provided.
Sex: F
Vaccine: COVID19
Symptoms: Postmenopausal haemorrhage
Clinical narrative: This spontaneous case reported by a pharmacist, describes the occurrence of postmenopausal hemorrhage (report of spotting post vaccination) in a female patient, of an unknown age, who received mRNA-1273 (Moderna COVID-19 vaccine) for COVID-19 immunization. No medical history reported. On an unknown date, patient received a dose of mRNA-1273 (Moderna COVID-19 vaccine), unknown route; 1 dosage form. On an unknown date, patient experienced postmenopausal hemorrhage (report of spotting post vaccination). At the time of the report, postmenopausal hemorrhage (report of spotting post vaccination) outcome: unknown. The action taken with mRNA-1273 (Moderna COVID-19 vaccine): unknown. The reporter did not provide any causality assessments, concomitant medication or treatment information. Patient was post menopausal and reported spotting post vaccination. Sender's comments: Based on the current available information and temporal association between the use of the product and the start of the event, a causal relationship cannot be excluded.
Sex: U
Vaccine: COVID19
Symptoms: COVID-19
Clinical narrative: got covid 3 months after vaccine; This spontaneous case was reported by a consumer and describes the occurrence of COVID-19 (got covid 3 months after vaccine) in a patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On an unknown date, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date,  after starting mRNA-1273 (Moderna COVID-19 Vaccine), the patient experienced COVID-19 (got covid 3 months after vaccine). At the time of the report, COVID-19 (got covid 3 months after vaccine) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No concomitant medication was reported No treatment medication was reported   Most recent FOLLOW-UP information incorporated above includes: On 09-Aug-2021: Non-significant follow up received and stated that patient got COVID after 3 months of vaccination
Sex: M
Vaccine: COVID19
Symptoms: Expired product administered, Extra dose administered
Clinical narrative: Expired dose given; The patient was told that the vaccine has expired and the patient was given another dose; This spontaneous case was reported by a consumer and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Expired dose given) and EXTRA DOSE ADMINISTERED (The patient was told that the vaccine has expired and the patient was given another dose) in a male patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.   On 07-Aug-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 07-Aug-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (Expired dose given) and EXTRA DOSE ADMINISTERED (The patient was told that the vaccine has expired and the patient was given another dose). On 07-Aug-2021, EXPIRED PRODUCT ADMINISTERED (Expired dose given) and EXTRA DOSE ADMINISTERED (The patient was told that the vaccine has expired and the patient was given another dose) had resolved.            No concomitant medications were reported. No treatment information was reported. The patient was not experiencing any side effect at the time of reporting.