chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 63.0
Sex: F
Vaccine: COVID19
Symptoms: Rash, Skin mass, Vaccination site erythema, Vaccination site mass
Clinical narrative: broke out with bumps everywhere; bumps from the tip of the shoulder to the injection site; rash; red bumps from the tip of the shoulder to the injection site; This spontaneous case was reported by a consumer and describes the occurrence of SKIN MASS (broke out with bumps everywhere), VACCINATION SITE MASS (bumps from the tip of the shoulder to the injection site), RASH (rash) and VACCINATION SITE ERYTHEMA (red bumps from the tip of the shoulder to the injection site) in a 63-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     Concurrent medical conditions included Thyroid disorder (it was reported as not clear whether hyperthyroidism or hypothyroidism,  also mentioned Hajimoto's disease.), Heart attack (Reported as twice almost has a heart attack.), Allergy multiple (reported as allergic to everything), Adhesive tape allergy (reported as allergic to band-aids), Eczema and Hashimoto's disease. Concomitant products included ASPIRIN [ACETYLSALICYLIC ACID] for an unknown indication.    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 SKIN MASS (broke out with bumps everywhere), VACCINATION SITE MASS (bumps from the tip of the shoulder to the injection site), RASH (rash) and VACCINATION SITE ERYTHEMA (red bumps from the tip of the shoulder to the injection site). At the time of the report, SKIN MASS (broke out with bumps everywhere), VACCINATION SITE MASS (bumps from the tip of the shoulder to the injection site), RASH (rash) and VACCINATION SITE ERYTHEMA (red bumps from the tip of the shoulder to the injection site) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No treatment medications were provided.   This case was linked to MOD-2021-286389 (Patient Link).
Age: 45.0
Sex: F
Vaccine: COVID19
Symptoms: Product dose omission issue
Clinical narrative: 1st dose 24Mar2021; no 2nd dose; This spontaneous case was reported by a consumer and describes the occurrence of PRODUCT DOSE OMISSION ISSUE (1st dose 24Mar2021; no 2nd dose) 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 24-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 13-Aug-2021, the patient experienced PRODUCT DOSE OMISSION ISSUE (1st dose 24Mar2021; no 2nd dose). On 13-Aug-2021, PRODUCT DOSE OMISSION ISSUE (1st dose 24Mar2021; no 2nd dose) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       Patient had had an antibody test in end  of Jun2021 or beginning of Jul2021 with a result of 20 (no units). No concomitant medications were reported. No treatment information were reported.
Age: 73.0
Sex: M
Vaccine: COVID19
Symptoms: COVID-19, Chills, Drug ineffective, Pyrexia, SARS-CoV-2 test
Clinical narrative: feeling feverish fever reached 101F; Chills; Tested positive for Covid-19/tested positive after 6 months; tested positive after 6 months; This case was received via an unknown source (no reference has been entered for a health authority or license partner) on 13-Aug-2021 and was forwarded to Moderna on 13-Aug-2021.    This spontaneous case was reported by a consumer and describes the occurrence of COVID-19 (Tested positive for Covid-19/tested positive after 6 months), DRUG INEFFECTIVE (tested positive after 6 months), PYREXIA (feeling feverish fever reached 101F) and CHILLS (Chills) in a 73-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 012L20A and 010M20A) for COVID-19 vaccination.     No Medical History information was reported.   On 09-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 06-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 11-Aug-2021, the patient experienced COVID-19 (Tested positive for Covid-19/tested positive after 6 months) and DRUG INEFFECTIVE (tested positive after 6 months). On an unknown date, the patient experienced PYREXIA (feeling feverish fever reached 101F) and CHILLS (Chills). At the time of the report, COVID-19 (Tested positive for Covid-19/tested positive after 6 months), PYREXIA (feeling feverish fever reached 101F) and CHILLS (Chills) had resolved and DRUG INEFFECTIVE (tested positive after 6 months) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 11-Aug-2021, SARS-CoV-2 test: positive (Positive) Tested positive for Covid-19.         Treatment medication was not provided.  Concomitant medication was not provided.   Most recent FOLLOW-UP information incorporated above includes: On 13-Aug-2021: Live Follow up received on 13-Aug-2021, event information updated
Sex: U
Vaccine: COVID19
Symptoms: Abdominal discomfort, Arthralgia, Chills, Headache, Illness
Clinical narrative: Was sick all night; Abdominal burning; Shaking; Fever; Muscle pain; Joint pain; severe headache; Chills; This spontaneous case was reported by a consumer and describes the occurrence of ILLNESS (Was sick all night), ABDOMINAL DISCOMFORT (Abdominal burning), TREMOR (Shaking), PYREXIA (Fever) and MYALGIA (Muscle pain) 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.     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 ILLNESS (Was sick all night), ABDOMINAL DISCOMFORT (Abdominal burning), TREMOR (Shaking), PYREXIA (Fever), MYALGIA (Muscle pain), ARTHRALGIA (Joint pain), HEADACHE (severe headache) and CHILLS (Chills). At the time of the report, ILLNESS (Was sick all night), ABDOMINAL DISCOMFORT (Abdominal burning), TREMOR (Shaking), PYREXIA (Fever), MYALGIA (Muscle pain), ARTHRALGIA (Joint pain), HEADACHE (severe headache) and CHILLS (Chills) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No concomitant drugs were  provided No treatment drugs were provided
Sex: U
Vaccine: COVID19
Symptoms: Myalgia, Pyrexia, Tremor
Clinical narrative: Was sick all night; Abdominal burning; Shaking; Fever; Muscle pain; Joint pain; severe headache; Chills; This spontaneous case was reported by a consumer and describes the occurrence of ILLNESS (Was sick all night), ABDOMINAL DISCOMFORT (Abdominal burning), TREMOR (Shaking), PYREXIA (Fever) and MYALGIA (Muscle pain) 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.     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 ILLNESS (Was sick all night), ABDOMINAL DISCOMFORT (Abdominal burning), TREMOR (Shaking), PYREXIA (Fever), MYALGIA (Muscle pain), ARTHRALGIA (Joint pain), HEADACHE (severe headache) and CHILLS (Chills). At the time of the report, ILLNESS (Was sick all night), ABDOMINAL DISCOMFORT (Abdominal burning), TREMOR (Shaking), PYREXIA (Fever), MYALGIA (Muscle pain), ARTHRALGIA (Joint pain), HEADACHE (severe headache) and CHILLS (Chills) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No concomitant drugs were  provided No treatment drugs were provided
Age: 30.0
Sex: M
Vaccine: COVID19
Symptoms: Arthralgia, Chest pain, Insomnia, Musculoskeletal chest pain, Neck pain
Clinical narrative: can't sleep; he's not even resting because of the pain irradiating from the neck and back, to ribs and chest; chest pain; pain went to the ribs; Neck pain; Shoulder pain; pain was from the injection site/the pain was excrutiating; This spontaneous case was reported by a non-health professional and describes the occurrence of MUSCULOSKELETAL CHEST PAIN (pain went to the ribs), CHEST PAIN (chest pain), INSOMNIA (can't sleep), RESTLESSNESS (he's not even resting because of the pain irradiating from the neck and back, to ribs and chest) and NECK PAIN (Neck pain) in a 30-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No medical history was provided.     On 09-Aug-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 10-Aug-2021, the patient experienced NECK PAIN (Neck pain), ARTHRALGIA (Shoulder pain) and VACCINATION SITE PAIN (pain was from the injection site/the pain was excrutiating). On 12-Aug-2021, the patient experienced MUSCULOSKELETAL CHEST PAIN (pain went to the ribs). On 13-Aug-2021, the patient experienced CHEST PAIN (chest pain). On an unknown date, the patient experienced INSOMNIA (can't sleep) and RESTLESSNESS (he's not even resting because of the pain irradiating from the neck and back, to ribs and chest). The patient was treated with IBUPROFEN (ADVIL [IBUPROFEN]) for Pain, at an unspecified dose and frequency. At the time of the report, MUSCULOSKELETAL CHEST PAIN (pain went to the ribs), CHEST PAIN (chest pain), INSOMNIA (can't sleep), RESTLESSNESS (he's not even resting because of the pain irradiating from the neck and back, to ribs and chest), NECK PAIN (Neck pain), ARTHRALGIA (Shoulder pain) and VACCINATION SITE PAIN (pain was from the injection site/the pain was excrutiating) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       Concomitant medications were not reported by the reporter.; Sender's Comments: Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded.
Age: 30.0
Sex: M
Vaccine: COVID19
Symptoms: Restlessness, Vaccination site pain
Clinical narrative: can't sleep; he's not even resting because of the pain irradiating from the neck and back, to ribs and chest; chest pain; pain went to the ribs; Neck pain; Shoulder pain; pain was from the injection site/the pain was excrutiating; This spontaneous case was reported by a non-health professional and describes the occurrence of MUSCULOSKELETAL CHEST PAIN (pain went to the ribs), CHEST PAIN (chest pain), INSOMNIA (can't sleep), RESTLESSNESS (he's not even resting because of the pain irradiating from the neck and back, to ribs and chest) and NECK PAIN (Neck pain) in a 30-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No medical history was provided.     On 09-Aug-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 10-Aug-2021, the patient experienced NECK PAIN (Neck pain), ARTHRALGIA (Shoulder pain) and VACCINATION SITE PAIN (pain was from the injection site/the pain was excrutiating). On 12-Aug-2021, the patient experienced MUSCULOSKELETAL CHEST PAIN (pain went to the ribs). On 13-Aug-2021, the patient experienced CHEST PAIN (chest pain). On an unknown date, the patient experienced INSOMNIA (can't sleep) and RESTLESSNESS (he's not even resting because of the pain irradiating from the neck and back, to ribs and chest). The patient was treated with IBUPROFEN (ADVIL [IBUPROFEN]) for Pain, at an unspecified dose and frequency. At the time of the report, MUSCULOSKELETAL CHEST PAIN (pain went to the ribs), CHEST PAIN (chest pain), INSOMNIA (can't sleep), RESTLESSNESS (he's not even resting because of the pain irradiating from the neck and back, to ribs and chest), NECK PAIN (Neck pain), ARTHRALGIA (Shoulder pain) and VACCINATION SITE PAIN (pain was from the injection site/the pain was excrutiating) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       Concomitant medications were not reported by the reporter.; Sender's Comments: Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded.
Age: 13.0
Sex: M
Vaccine: COVID19
Symptoms: Product administered to patient of inappropriate age
Clinical narrative: 13 year old was given the Moderna COVID-19 vaccine; This spontaneous case was reported by an other health care professional and describes the occurrence of PRODUCT ADMINISTERED TO PATIENT OF INAPPROPRIATE AGE (13 year old was given the Moderna COVID-19 vaccine) in a 13-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 037C1A) for COVID-19 vaccination.     No Medical History information was reported.    On 12-Aug-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 12-Aug-2021, the patient experienced PRODUCT ADMINISTERED TO PATIENT OF INAPPROPRIATE AGE (13 year old was given the Moderna COVID-19 vaccine). On 12-Aug-2021, PRODUCT ADMINISTERED TO PATIENT OF INAPPROPRIATE AGE (13 year old was given the Moderna COVID-19 vaccine) 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.
Age: 74.0
Sex: F
Vaccine: COVID19
Symptoms: Headache, Loss of personal independence in daily activities, Sneezing
Clinical narrative: headache/horrendous headache; I couldn't do anything I was lying down the whole time; she reported she is now sneezing occasionally; This spontaneous case was reported by a consumer and describes the occurrence of HEADACHE (headache/horrendous headache), LOSS OF PERSONAL INDEPENDENCE IN DAILY ACTIVITIES (I couldn't do anything I was lying down the whole time) and SNEEZING (she reported she is now sneezing occasionally) in a 74-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 031L20A) for COVID-19 vaccination.     Concomitant products included CALCIUM, VITAMIN C [ASCORBIC ACID] and COLECALCIFEROL (VITAMIN D3) for an unknown indication.    On 05-Feb-2021, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced HEADACHE (headache/horrendous headache), LOSS OF PERSONAL INDEPENDENCE IN DAILY ACTIVITIES (I couldn't do anything I was lying down the whole time) and SNEEZING (she reported she is now sneezing occasionally). At the time of the report, HEADACHE (headache/horrendous headache), LOSS OF PERSONAL INDEPENDENCE IN DAILY ACTIVITIES (I couldn't do anything I was lying down the whole time) and SNEEZING (she reported she is now sneezing occasionally) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.
Age: 48.0
Sex: U
Vaccine: COVID19
Symptoms: Expired product administered
Clinical narrative: patients who received a vaccine which was more than 30 days in the refrigerator/For this patient, the number of days that have passed were 11; This spontaneous case was reported by an other health care professional and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (patients who received a vaccine which was more than 30 days in the refrigerator/For this patient, the number of days that have passed were 11) in a 48-year-old patient of an unknown gender who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.   On 14-Jul-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 14-Jul-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (patients who received a vaccine which was more than 30 days in the refrigerator/For this patient, the number of days that have passed were 11). On 14-Jul-2021, EXPIRED PRODUCT ADMINISTERED (patients who received a vaccine which was more than 30 days in the refrigerator/For this patient, the number of days that have passed were 11) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No relevant concomitant medications were reported.  No treatment information was provided.
Age: 69.0
Sex: F
Vaccine: COVID19
Symptoms: Arthralgia, Impaired driving ability, Infection, Mobility decreased, Neck pain
Clinical narrative: pain spread to her wrist; could barely move her hands; pain now moving up both arms; pain is now spreading to her neck; patient is not able to drive as a result of these conditions; Infection or inflammation; This spontaneous case was reported by a consumer and describes the occurrence of ARTHRALGIA (pain spread to her wrist), MOBILITY DECREASED (could barely move her hands), PAIN IN EXTREMITY (pain now moving up both arms), NECK PAIN (pain is now spreading to her neck), IMPAIRED DRIVING ABILITY (patient is not able to drive as a result of these conditions) and INFECTION (Infection or inflammation) in a 69-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 002B21A) for COVID-19 vaccination.     Concomitant products included PREDNISONE for Pain.    On 18-Mar-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 ARTHRALGIA (pain spread to her wrist) (seriousness criterion medically significant), MOBILITY DECREASED (could barely move her hands) (seriousness criterion medically significant), PAIN IN EXTREMITY (pain now moving up both arms) (seriousness criterion medically significant), NECK PAIN (pain is now spreading to her neck) (seriousness criterion medically significant), IMPAIRED DRIVING ABILITY (patient is not able to drive as a result of these conditions) (seriousness criterion medically significant) and INFECTION (Infection or inflammation) (seriousness criterion medically significant). The patient was treated with IBUPROFEN ongoing since an unknown date for Pain, at an unspecified dose and frequency and ACETAMINOPHEN ongoing since an unknown date for Pain, at an unspecified dose and frequency. At the time of the report, ARTHRALGIA (pain spread to her wrist), MOBILITY DECREASED (could barely move her hands), PAIN IN EXTREMITY (pain now moving up both arms), NECK PAIN (pain is now spreading to her neck) and IMPAIRED DRIVING ABILITY (patient is not able to drive as a result of these conditions) outcome was unknown and INFECTION (Infection or inflammation) had not resolved.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, White blood cell count: increased (High) increased.         The patient had appointments with accupuncture , rheumatology and a chiropractor The patient was tested for Lupus, Leukemia, Carpal Tunnel and all were ruled out.  Treatment medications include steroid injection and steroid cream for pain.  Company comment: Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded.   This case was linked to MOD-2021-286198 (Patient Link).; Sender's Comments: Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded
Age: 69.0
Sex: F
Vaccine: COVID19
Symptoms: Pain in extremity, White blood cell count
Clinical narrative: pain spread to her wrist; could barely move her hands; pain now moving up both arms; pain is now spreading to her neck; patient is not able to drive as a result of these conditions; Infection or inflammation; This spontaneous case was reported by a consumer and describes the occurrence of ARTHRALGIA (pain spread to her wrist), MOBILITY DECREASED (could barely move her hands), PAIN IN EXTREMITY (pain now moving up both arms), NECK PAIN (pain is now spreading to her neck), IMPAIRED DRIVING ABILITY (patient is not able to drive as a result of these conditions) and INFECTION (Infection or inflammation) in a 69-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 002B21A) for COVID-19 vaccination.     Concomitant products included PREDNISONE for Pain.    On 18-Mar-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 ARTHRALGIA (pain spread to her wrist) (seriousness criterion medically significant), MOBILITY DECREASED (could barely move her hands) (seriousness criterion medically significant), PAIN IN EXTREMITY (pain now moving up both arms) (seriousness criterion medically significant), NECK PAIN (pain is now spreading to her neck) (seriousness criterion medically significant), IMPAIRED DRIVING ABILITY (patient is not able to drive as a result of these conditions) (seriousness criterion medically significant) and INFECTION (Infection or inflammation) (seriousness criterion medically significant). The patient was treated with IBUPROFEN ongoing since an unknown date for Pain, at an unspecified dose and frequency and ACETAMINOPHEN ongoing since an unknown date for Pain, at an unspecified dose and frequency. At the time of the report, ARTHRALGIA (pain spread to her wrist), MOBILITY DECREASED (could barely move her hands), PAIN IN EXTREMITY (pain now moving up both arms), NECK PAIN (pain is now spreading to her neck) and IMPAIRED DRIVING ABILITY (patient is not able to drive as a result of these conditions) outcome was unknown and INFECTION (Infection or inflammation) had not resolved.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, White blood cell count: increased (High) increased.         The patient had appointments with accupuncture , rheumatology and a chiropractor The patient was tested for Lupus, Leukemia, Carpal Tunnel and all were ruled out.  Treatment medications include steroid injection and steroid cream for pain.  Company comment: Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded.   This case was linked to MOD-2021-286198 (Patient Link).; Sender's Comments: Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded
Age: 48.0
Sex: F
Vaccine: COVID19
Symptoms: Dyspepsia, Heart rate increased, Hot flush
Clinical narrative: Immediately after the injection she felt a hot flash; Then an hour later she had a rapid heart rate; Then an hour later she had a rapid heart rate and heartburn; This spontaneous case was reported by a consumer and describes the occurrence of HOT FLUSH (Immediately after the injection she felt a hot flash), HEART RATE INCREASED (Then an hour later she had a rapid heart rate) and DYSPEPSIA (Then an hour later she had a rapid heart rate and heartburn) in a 48-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 008021A) for COVID-19 vaccination.     No Medical History information was reported.    On 29-Jul-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 29-Jul-2021, the patient experienced HOT FLUSH (Immediately after the injection she felt a hot flash), HEART RATE INCREASED (Then an hour later she had a rapid heart rate) and DYSPEPSIA (Then an hour later she had a rapid heart rate and heartburn). On 29-Jul-2021, HOT FLUSH (Immediately after the injection she felt a hot flash), HEART RATE INCREASED (Then an hour later she had a rapid heart rate) and DYSPEPSIA (Then an hour later she had a rapid heart rate and heartburn) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Concomitant product use was not provided. Treatment information was not provided.
Age: 66.0
Sex: M
Vaccine: COVID19
Symptoms: Inappropriate schedule of product administration, Near death experience, SARS-CoV-2 antibody test, Swelling face
Clinical narrative: He could die from it; jaw swelled up again; received the second Moderna COVID-19 dose, skipped his second Moderna dose appointment; swollen jaw; This spontaneous case was reported by a consumer and describes the occurrence of NEAR DEATH EXPERIENCE (He could die from it) in a 66-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 030M20A and 026A21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     Previously administered products included for an unreported indication: FLU VACCINE VII (he gets the Flu vaccine every year.). Concurrent medical conditions included Blood pressure high, Diabetic and High cholesterol. Concomitant products included LISINOPRIL for Blood pressure high, INSULIN for an unknown indication.   On 11-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 11-Aug-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 18-Feb-2021, the patient experienced SWELLING FACE (swollen jaw). On 11-Aug-2021, the patient experienced INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (received the second Moderna COVID-19 dose, skipped his second Moderna dose appointment). On an unknown date, the patient experienced NEAR DEATH EXPERIENCE (He could die from it) (seriousness criterion medically significant) and SWELLING FACE (jaw swelled up again). At the time of the report, NEAR DEATH EXPERIENCE (He could die from it) and SWELLING FACE (jaw swelled up again) outcome was unknown and SWELLING FACE (swollen jaw) and INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (received the second Moderna COVID-19 dose, skipped his second Moderna dose appointment) had resolved.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 11-Aug-2021, SARS-CoV-2 antibody test: negative (Negative) COVID-19 antibody test  negative..     The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded.; Sender's Comments: Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded.
Sex: U
Vaccine: COVID19
Symptoms: Expired product administered
Clinical narrative: Administering an expired vaccine to a patient; Based on the current case data, this case has been classified as invalid. This spontaneous case was reported by a pharmacist and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Administering an expired vaccine to a patient) in a patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 052E21A) for COVID-19 vaccination.     No Medical History information was reported.    On 13-Aug-2021, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 13-Aug-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (Administering an expired vaccine to a patient). On 13-Aug-2021, EXPIRED PRODUCT ADMINISTERED (Administering an expired vaccine to a patient) had resolved.        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 reported. No treatment information was provided. The vaccine vial was punctured and moved from the refrigerator to room temperature at 11:25 A.M in previous day, 12-Aug-2021, and this vial has been stored in room temperature since then.
Sex: U
Vaccine: COVID19
Symptoms: COVID-19, Rhinorrhoea
Clinical narrative: Runny nose; Tested positive for Covid; This spontaneous case was reported by a consumer and describes the occurrence of COVID-19 (Tested positive for Covid) and RHINORRHOEA (Runny nose) in a  patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. Unknown) for COVID-19 vaccination.     No Medical History information was reported.    On 05-Aug-2021, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 12-Aug-2021, the patient experienced COVID-19 (Tested positive for Covid). On an unknown date, the patient experienced RHINORRHOEA (Runny nose). At the time of the report, COVID-19 (Tested positive for Covid) and RHINORRHOEA (Runny nose) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 12-Aug-2021, COVID-19: positive (Positive) Positive.     The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.     Company Comment: Based on the mechanism of action of mRNA-1273 causal association between the event of COVID-19 infection and mRNA-1273 is assessed as not applicable. For the event RHINORRHOEA, causality is assessed as possible, however this event could be due COVID-19.; Sender's Comments: Based on the mechanism of action of mRNA-1273 causal association between the event of COVID-19 infection and mRNA-1273 is assessed as not applicable.For the event RHINORRHOEA, causality is assessed as possible, however this event could be due COVID-19.
Age: 57.0
Sex: F
Vaccine: COVID19
Symptoms: Acute myocardial infarction, Blood pressure measurement, Chest pain, Dizziness, Nausea
Clinical narrative: Diagnosed with having a non-STEMI heart attack; Patient woke up and room was spinning (Vertigo); Dizzy; Nauseous; Throwing up; Chest pain; This spontaneous case was reported by a consumer and describes the occurrence of ACUTE MYOCARDIAL INFARCTION (Diagnosed with having a non-STEMI heart attack), VERTIGO (Patient woke up and room was spinning (Vertigo)), DIZZINESS (Dizzy), NAUSEA (Nauseous), VOMITING (Throwing up) and CHEST PAIN (Chest pain) in a 57-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 012L20A) for COVID-19 vaccination.     No Medical History information was reported.  On 31-Jul-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 08-Aug-2021, the patient experienced ACUTE MYOCARDIAL INFARCTION (Diagnosed with having a non-STEMI heart attack) (seriousness criteria hospitalization and medically significant), DIZZINESS (Dizzy) (seriousness criterion hospitalization), NAUSEA (Nauseous) (seriousness criterion hospitalization), VOMITING (Throwing up) (seriousness criterion hospitalization prolonged) and CHEST PAIN (Chest pain) (seriousness criterion hospitalization). 08-Aug-2021, the patient experienced VERTIGO (Patient woke up and room was spinning (Vertigo)) (seriousness criterion hospitalization). The patient was hospitalized from 08-Aug-2021 to 12-Aug-2021 due to ACUTE MYOCARDIAL INFARCTION, CHEST PAIN, DIZZINESS, NAUSEA, VERTIGO and VOMITING. At the time of the report, ACUTE MYOCARDIAL INFARCTION (Diagnosed with having a non-STEMI heart attack), VERTIGO (Patient woke up and room was spinning (Vertigo)), DIZZINESS (Dizzy), NAUSEA (Nauseous), VOMITING (Throwing up) and CHEST PAIN (Chest pain) outcome was unknown.  DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 08-Aug-2021, Blood pressure measurement: 224/113 (High) 224/113.  The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.  Concomitant medications included heart medicine, cholesterol and high blood pressure medicine.  Treatment information was not provided.  Company comment: Very limited information regarding the events of acute myocardial infarction and chest pain has been provided at this time, additional information required. A causal relationship cannot be excluded for the events of vomiting, nausea, vertigo and dizziness; Sender's Comments: Very limited information regarding the events of acute myocardial infarction and chest pain has been provided at this time, additional information required. A causal relationship cannot be excluded for the events of vomiting, nausea, vertigo and dizziness.
Age: 57.0
Sex: F
Vaccine: COVID19
Symptoms: Vertigo, Vomiting
Clinical narrative: Diagnosed with having a non-STEMI heart attack; Patient woke up and room was spinning (Vertigo); Dizzy; Nauseous; Throwing up; Chest pain; This spontaneous case was reported by a consumer and describes the occurrence of ACUTE MYOCARDIAL INFARCTION (Diagnosed with having a non-STEMI heart attack), VERTIGO (Patient woke up and room was spinning (Vertigo)), DIZZINESS (Dizzy), NAUSEA (Nauseous), VOMITING (Throwing up) and CHEST PAIN (Chest pain) in a 57-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 012L20A) for COVID-19 vaccination.     No Medical History information was reported.  On 31-Jul-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 08-Aug-2021, the patient experienced ACUTE MYOCARDIAL INFARCTION (Diagnosed with having a non-STEMI heart attack) (seriousness criteria hospitalization and medically significant), DIZZINESS (Dizzy) (seriousness criterion hospitalization), NAUSEA (Nauseous) (seriousness criterion hospitalization), VOMITING (Throwing up) (seriousness criterion hospitalization prolonged) and CHEST PAIN (Chest pain) (seriousness criterion hospitalization). 08-Aug-2021, the patient experienced VERTIGO (Patient woke up and room was spinning (Vertigo)) (seriousness criterion hospitalization). The patient was hospitalized from 08-Aug-2021 to 12-Aug-2021 due to ACUTE MYOCARDIAL INFARCTION, CHEST PAIN, DIZZINESS, NAUSEA, VERTIGO and VOMITING. At the time of the report, ACUTE MYOCARDIAL INFARCTION (Diagnosed with having a non-STEMI heart attack), VERTIGO (Patient woke up and room was spinning (Vertigo)), DIZZINESS (Dizzy), NAUSEA (Nauseous), VOMITING (Throwing up) and CHEST PAIN (Chest pain) outcome was unknown.  DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 08-Aug-2021, Blood pressure measurement: 224/113 (High) 224/113.  The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.  Concomitant medications included heart medicine, cholesterol and high blood pressure medicine.  Treatment information was not provided.  Company comment: Very limited information regarding the events of acute myocardial infarction and chest pain has been provided at this time, additional information required. A causal relationship cannot be excluded for the events of vomiting, nausea, vertigo and dizziness; Sender's Comments: Very limited information regarding the events of acute myocardial infarction and chest pain has been provided at this time, additional information required. A causal relationship cannot be excluded for the events of vomiting, nausea, vertigo and dizziness.
Age: 41.0
Sex: U
Vaccine: COVID19
Symptoms: Expired product administered
Clinical narrative: Expired vaccine used; This spontaneous case was reported by a nurse and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Expired vaccine used) in a 42-year-old patient of an unknown gender who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.   On 08-Jul-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 08-Jul-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (Expired vaccine used). On 08-Jul-2021, EXPIRED PRODUCT ADMINISTERED (Expired vaccine used) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant information was provided by the reporter.  No treatment information was provided.
Age: 60.0
Sex: U
Vaccine: COVID19
Symptoms: Expired product administered, Product storage error
Clinical narrative: received a vaccine which was more than 30 days in the refrigerator (30 days were on 03Jul2021); received a vaccine which was more than 30 days in the refrigerator (30 days were on 03Jul2021); This spontaneous case was reported by an other health care professional and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (received a vaccine which was more than 30 days in the refrigerator (30 days were on 03Jul2021)) and PRODUCT STORAGE ERROR (received a vaccine which was more than 30 days in the refrigerator (30 days were on 03Jul2021)) in a 60-year-old patient of an unknown gender who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. Unknown) for COVID-19 vaccination.     No Medical History information was reported.   On 08-Jul-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 08-Jul-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (received a vaccine which was more than 30 days in the refrigerator (30 days were on 03Jul2021)) and PRODUCT STORAGE ERROR (received a vaccine which was more than 30 days in the refrigerator (30 days were on 03Jul2021)). At the time of the report, EXPIRED PRODUCT ADMINISTERED (received a vaccine which was more than 30 days in the refrigerator (30 days were on 03Jul2021)) and PRODUCT STORAGE ERROR (received a vaccine which was more than 30 days in the refrigerator (30 days were on 03Jul2021)) had resolved.      For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant information was provided by the reporter.  No treatment information was provided.
Sex: U
Vaccine: COVID19
Symptoms: Chest pain, Chills, Myalgia
Clinical narrative: chest pain; chills; muscle pain; This spontaneous case was reported by a consumer and describes the occurrence of CHEST PAIN (chest pain), CHILLS (chills) and MYALGIA (muscle pain) 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 CHEST PAIN (chest pain), CHILLS (chills) and MYALGIA (muscle pain). At the time of the report, CHEST PAIN (chest pain), CHILLS (chills) and MYALGIA (muscle pain) had not resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No treatment information was provided. No concomitant medication was provided. Patient received vaccination a week ago but as of 3 days ago.
Age: 60.0
Sex: U
Vaccine: COVID19
Symptoms: Expired product administered
Clinical narrative: Expired vaccine used; This spontaneous case was reported by an other health care professional and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Expired vaccine used) in a 60-year-old patient of an unknown gender who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.   On 08-Jul-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 EXPIRED PRODUCT ADMINISTERED (Expired vaccine used). At the time of the report, EXPIRED PRODUCT ADMINISTERED (Expired vaccine used) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No Concomitant medications were reported. No Treatment medications were reported.  Patient received vaccine which was more than 30 days in the refrigerator (30 days were on 03-JUL-2021). For this patient, the number of days that have passed were 5.
Sex: U
Vaccine: COVID19
Symptoms: Bone pain, Fatigue
Clinical narrative: Bone pain; Fatigue; This spontaneous case was reported by a consumer and describes the occurrence of BONE PAIN (Bone pain) and FATIGUE (Fatigue) in a  patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 059E21A) for COVID-19 vaccination.     No Medical History information was reported.   On 12-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 13-Aug-2021, the patient experienced BONE PAIN (Bone pain) and FATIGUE (Fatigue). At the time of the report, BONE PAIN (Bone pain) and FATIGUE (Fatigue) outcome was unknown.            No concomitant medication was  provided.  No treatment  medication was  provided.   Reporter did not allow further contact
Age: 22.0
Sex: U
Vaccine: COVID19
Symptoms: Expired product administered
Clinical narrative: received a vaccine which was more than 30 days in the refrigerator (30 days were on 03Jul2021.; This spontaneous case was reported by an other health care professional and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (received a vaccine which was more than 30 days in the refrigerator (30 days were on 03Jul2021.) in a 22-year-old patient of an unknown gender who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.   On 08-Jul-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 EXPIRED PRODUCT ADMINISTERED (received a vaccine which was more than 30 days in the refrigerator (30 days were on 03Jul2021.). At the time of the report, EXPIRED PRODUCT ADMINISTERED (received a vaccine which was more than 30 days in the refrigerator (30 days were on 03Jul2021.) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No Concomitant medications were reported.  No Treatment medications were reported.
Age: 65.0
Sex: U
Vaccine: COVID19
Symptoms: Expired product administered
Clinical narrative: received a vaccine which was more than 30 days in the refrigerator/the number of days that have passed were 11; This spontaneous case was reported by an other health care professional and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (received a vaccine which was more than 30 days in the refrigerator/the number of days that have passed were 11) in a 65-year-old patient of an unknown gender who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.   On 14-Jul-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 14-Jul-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (received a vaccine which was more than 30 days in the refrigerator/the number of days that have passed were 11). On 14-Jul-2021, EXPIRED PRODUCT ADMINISTERED (received a vaccine which was more than 30 days in the refrigerator/the number of days that have passed were 11) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant information was provided by the reporter.  No treatment information was provided.
Age: 74.0
Sex: F
Vaccine: COVID19
Symptoms: Facial pain, Mastication disorder, Speech disorder, Trigeminal neuralgia
Clinical narrative: Severe facial pain; Could not chew or talk, very debilitating; Trigeminal neuralgia; Could not chew or talk, very debilitating; This spontaneous case was reported by a consumer and describes the occurrence of FACIAL PAIN (Severe facial pain), MASTICATION DISORDER (Could not chew or talk, very debilitating), TRIGEMINAL NEURALGIA (Trigeminal neuralgia) and SPEECH DISORDER (Could not chew or talk, very debilitating) in a 74-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 001B20A and 006M20A) for COVID-19 vaccination.     Concurrent medical conditions included Facial pain (Patient had an episode of facial pain) since January 2021.   On 17-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 17-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient experienced FACIAL PAIN (Severe facial pain), MASTICATION DISORDER (Could not chew or talk, very debilitating), TRIGEMINAL NEURALGIA (Trigeminal neuralgia) and SPEECH DISORDER (Could not chew or talk, very debilitating). At the time of the report, FACIAL PAIN (Severe facial pain), MASTICATION DISORDER (Could not chew or talk, very debilitating), TRIGEMINAL NEURALGIA (Trigeminal neuralgia) and SPEECH DISORDER (Could not chew or talk, very debilitating) outcome was unknown.            No concomitant medications were provided by the reporter. No treatment medications were provided by the reporter.
Age: 28.0
Sex: U
Vaccine: COVID19
Symptoms: Expired product administered, Product storage error
Clinical narrative: all the patients who received a vaccine which was more than 30 days in the refrigerator; received a vaccine which was more than 30 days in the refrigerator/the number of days that have passed were 11; This spontaneous case was reported by an other health care professional and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (received a vaccine which was more than 30 days in the refrigerator/the number of days that have passed were 11) and PRODUCT STORAGE ERROR (all the patients who received a vaccine which was more than 30 days in the refrigerator) in a 28-year-old patient of an unknown gender who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.   On 14-Jul-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 14-Jul-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (received a vaccine which was more than 30 days in the refrigerator/the number of days that have passed were 11). On an unknown date, the patient experienced PRODUCT STORAGE ERROR (all the patients who received a vaccine which was more than 30 days in the refrigerator). On 14-Jul-2021, EXPIRED PRODUCT ADMINISTERED (received a vaccine which was more than 30 days in the refrigerator/the number of days that have passed were 11) had resolved. At the time of the report, PRODUCT STORAGE ERROR (all the patients who received a vaccine which was more than 30 days in the refrigerator) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant medications were reported.  No treatment medications were reported.