chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 26.0
Sex: M
Vaccine: COVID19
Symptoms: Vaccination site pain, Vaccination site swelling
Clinical narrative: could not lift his left arm elbow higher than his shoulder; soft cough; spitting out flem; headache; swollen lymph nodes on both the right and left side of neck; painful injection site left arm; swollen injection site left arm; This spontaneous case was reported by a consumer and describes the occurrence of COUGH (soft cough), PRODUCTIVE COUGH (spitting out flem), MOBILITY DECREASED (could not lift his left arm elbow higher than his shoulder), VACCINATION SITE PAIN (painful injection site left arm) and VACCINATION SITE SWELLING (swollen injection site left arm) in a 26-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 0748C21A E) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.    On 02-Jul-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 02-Jul-2021, the patient experienced VACCINATION SITE PAIN (painful injection site left arm) and VACCINATION SITE SWELLING (swollen injection site left arm). On 05-Jul-2021, the patient experienced LYMPHADENOPATHY (swollen lymph nodes on both the right and left side of neck). On 08-Jul-2021, the patient experienced COUGH (soft cough), PRODUCTIVE COUGH (spitting out flem) and HEADACHE (headache). On an unknown date, the patient experienced MOBILITY DECREASED (could not lift his left arm elbow higher than his shoulder). On 04-Jul-2021, VACCINATION SITE PAIN (painful injection site left arm) and VACCINATION SITE SWELLING (swollen injection site left arm) had resolved. On 07-Jul-2021, LYMPHADENOPATHY (swollen lymph nodes on both the right and left side of neck) had resolved. At the time of the report, COUGH (soft cough), PRODUCTIVE COUGH (spitting out flem), MOBILITY DECREASED (could not lift his left arm elbow higher than his shoulder) and HEADACHE (headache) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Patient  had received his Moderna Covid-19 vaccine at  Supermarket. Treatment information was not provided Concomitant medication were not provided.   Most recent FOLLOW-UP information incorporated above includes: On 09-Jul-2021: Translation received on 09 Jul 2021 and does not contain any new information.
Age: 26.0
Sex: F
Vaccine: COVID19
Symptoms: Feeling hot, Headache, Hyperhidrosis, Pyrexia, Vomiting
Clinical narrative: sweating; really hot; headache; vomiting; fever; This spontaneous case was reported by a consumer and describes the occurrence of HYPERHIDROSIS (sweating), FEELING HOT (really hot), HEADACHE (headache), VOMITING (vomiting) and PYREXIA (fever) in a 26-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 004B21A and 004B21A) for COVID-19 vaccination.     No Medical History information was reported.   On 05-Jun-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 03-Jul-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 HYPERHIDROSIS (sweating), FEELING HOT (really hot), HEADACHE (headache), VOMITING (vomiting) and PYREXIA (fever). The patient was treated with IBUPROFEN (ADVIL [IBUPROFEN]) for Adverse event, at an unspecified dose and frequency. At the time of the report, HYPERHIDROSIS (sweating), FEELING HOT (really hot), HEADACHE (headache), VOMITING (vomiting) and PYREXIA (fever) outcome was unknown.            No relevant concomitant medications were provided. No treatment information was provided.
Age: 51.0
Sex: F
Vaccine: COVID19
Symptoms: Product dose omission issue
Clinical narrative: It has been more than 35 days since first dose; This spontaneous case was reported by a consumer and describes the occurrence of PRODUCT DOSE OMISSION ISSUE (It has been more than 35 days since first dose) in a 51-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On 12-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 12-Apr-2021, the patient experienced PRODUCT DOSE OMISSION ISSUE (It has been more than 35 days since first dose). At the time of the report, PRODUCT DOSE OMISSION ISSUE (It has been more than 35 days since first dose) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No concomitant and treatment information were reported by the reporter.
Age: 42.0
Sex: F
Vaccine: COVID19
Symptoms: Erythema, Headache, Myalgia, Pruritus, Pyrexia
Clinical narrative: Itchiness; Redness; Rashes all over body; Muscle pain; Headache; Fever; This spontaneous case was reported by a consumer and describes the occurrence of PRURITUS (Itchiness), ERYTHEMA (Redness), RASH (Rashes all over body), MYALGIA (Muscle pain) and HEADACHE (Headache) in a 42-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 031B21A and 031B21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.   On 02-Jun-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 30-Jun-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 30-Jun-2021, the patient experienced PRURITUS (Itchiness), ERYTHEMA (Redness), MYALGIA (Muscle pain), HEADACHE (Headache) and PYREXIA (Fever). 30-Jun-2021, the patient experienced RASH (Rashes all over body). At the time of the report, PRURITUS (Itchiness) had not resolved and ERYTHEMA (Redness), RASH (Rashes all over body), MYALGIA (Muscle pain), HEADACHE (Headache) and PYREXIA (Fever) had resolved.            No Concomitant medications were reported.  No Treatment information was reported.
Age: 42.0
Sex: F
Vaccine: COVID19
Symptoms: Rash
Clinical narrative: Itchiness; Redness; Rashes all over body; Muscle pain; Headache; Fever; This spontaneous case was reported by a consumer and describes the occurrence of PRURITUS (Itchiness), ERYTHEMA (Redness), RASH (Rashes all over body), MYALGIA (Muscle pain) and HEADACHE (Headache) in a 42-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 031B21A and 031B21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.   On 02-Jun-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 30-Jun-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 30-Jun-2021, the patient experienced PRURITUS (Itchiness), ERYTHEMA (Redness), MYALGIA (Muscle pain), HEADACHE (Headache) and PYREXIA (Fever). 30-Jun-2021, the patient experienced RASH (Rashes all over body). At the time of the report, PRURITUS (Itchiness) had not resolved and ERYTHEMA (Redness), RASH (Rashes all over body), MYALGIA (Muscle pain), HEADACHE (Headache) and PYREXIA (Fever) had resolved.            No Concomitant medications were reported.  No Treatment information was reported.
Sex: U
Vaccine: COVID19
Symptoms: Expired product administered
Clinical narrative: Administered 10 doses of Moderna COVID Vaccine after the 30 day refrigerator guideline; This case was received via an unknown source (no reference has been entered for a health authority or license partner) on 08-Jul-2021 and was forwarded to Moderna on 08-Jul-2021.    Based on the current case data, this case has been classified as invalid. This spontaneous case was reported by a health care professional and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Administered 10 doses of Moderna COVID Vaccine after the 30 day refrigerator guideline) in a patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 051C21A) for COVID-19 vaccination.     No Medical History information was reported.    On an unknown date, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced EXPIRED PRODUCT ADMINISTERED (Administered 10 doses of Moderna COVID Vaccine after the 30 day refrigerator guideline). At the time of the report, EXPIRED PRODUCT ADMINISTERED (Administered 10 doses of Moderna COVID Vaccine after the 30 day refrigerator guideline) 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.   Medical history and Concomitant medications details are not provided by the Reporter. Vial was first moved to the fridge on 03JUN2021. On 05JUL2021,06JUL2021 and 07JUL 2021 10 doses of Moderna COVID Vaccine was administered after the 30 day refrigerator guideline. Doses were meant to be expired on Sunday July 4th but overall 10 doses were administered to 10 patients between 05JUL2021 and 07JUL2021 while they were stored in the refrigeration between 35 and 46 Degree F. No treatment information is provided.   Most recent FOLLOW-UP information incorporated above includes: On 08-Jul-2021: Follow-up information received on 8 JUL 2021 contains no new information.
Sex: U
Vaccine: COVID19
Symptoms: Illness
Clinical narrative: Bunch of people got sick after getting Moderna vaccine; Based on the current case data, this case has been classified as invalid. This spontaneous case was reported by a consumer and describes the occurrence of ILLNESS (Bunch of people got sick after getting Moderna vaccine) 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 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 ILLNESS (Bunch of people got sick after getting Moderna vaccine). At the time of the report, ILLNESS (Bunch of people got sick after getting Moderna vaccine) 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: Product dose omission issue
Clinical narrative: first dose administered in 17Apr2021, second dose not administered yet.; This spontaneous case was reported by a consumer and describes the occurrence of PRODUCT DOSE OMISSION ISSUE (first dose administered in 17Apr2021, second dose not administered yet.) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.   On 17-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 17-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 17-Apr-2021, the patient experienced PRODUCT DOSE OMISSION ISSUE (first dose administered in 17Apr2021, second dose not administered yet.). On 17-Apr-2021, PRODUCT DOSE OMISSION ISSUE (first dose administered in 17Apr2021, second dose not administered yet.) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       Concomitant product details was not reported.  Treatment details was not reported .
Age: 14.0
Sex: F
Vaccine: COVID19
Symptoms: Product administered to patient of inappropriate age
Clinical narrative: 1st and 2nd dose given to a 14 year old; This spontaneous case was reported by a nurse and describes the occurrence of PRODUCT ADMINISTERED TO PATIENT OF INAPPROPRIATE AGE (1st and 2nd dose given to a 14 year old) in a 14-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 053C21A and 014C21A) for COVID-19 vaccination.     No Medical History information was reported.   On 19-May-2021 at 9:48 AM, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 15-Jun-2021 at 10:40 AM, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 19-May-2021, the patient experienced PRODUCT ADMINISTERED TO PATIENT OF INAPPROPRIATE AGE (1st and 2nd dose given to a 14 year old). On 15-Jun-2021, PRODUCT ADMINISTERED TO PATIENT OF INAPPROPRIATE AGE (1st and 2nd dose given to a 14 year old) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   Concomitant and treatment medications were not reported.   Most recent FOLLOW-UP information incorporated above includes: On 28-Jul-2021: Follow up received indicated the patient did not experience any adverse reactions/ events after the administration of the vaccine. On 30-Aug-2021: The follow-up information received contain Non Significant Information.
Age: 59.0
Sex: F
Vaccine: COVID19
Symptoms: Cheilitis, Feeling abnormal, Oral mucosal eruption, Product dose omission issue, Rash
Clinical narrative: the patient lost her mind( started to behave like someone on drugs ); had  big open sores on back of her hands; patient didn't receive the second dose; " her mouth is mess"/developed rashes in mouth and lips; developed rashes in lips; developed rashes on her upper body; This spontaneous case was reported by a consumer (subsequently medically confirmed) and describes the occurrence of FEELING ABNORMAL (the patient lost her mind( started to behave like someone on drugs )), SKIN ULCER (had  big open sores on back of her hands), PRODUCT DOSE OMISSION ISSUE (patient didn't receive the second dose), ORAL MUCOSAL ERUPTION (" her mouth is mess"/developed rashes in mouth and lips) and CHEILITIS (developed rashes in lips) in a 59-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.    On 01-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced FEELING ABNORMAL (the patient lost her mind( started to behave like someone on drugs )), SKIN ULCER (had  big open sores on back of her hands), PRODUCT DOSE OMISSION ISSUE (patient didn't receive the second dose), ORAL MUCOSAL ERUPTION (" her mouth is mess"/developed rashes in mouth and lips), CHEILITIS (developed rashes in lips) and RASH (developed rashes on her upper body). The patient was treated with PREDNISONE at an unspecified dose and frequency. At the time of the report, FEELING ABNORMAL (the patient lost her mind( started to behave like someone on drugs )), SKIN ULCER (had  big open sores on back of her hands), PRODUCT DOSE OMISSION ISSUE (patient didn't receive the second dose), ORAL MUCOSAL ERUPTION (" her mouth is mess"/developed rashes in mouth and lips), CHEILITIS (developed rashes in lips) and RASH (developed rashes on her upper body) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No concomitant medication was reported. Treatment included antibiotics and topical steroids
Age: 59.0
Sex: F
Vaccine: COVID19
Symptoms: Skin ulcer
Clinical narrative: the patient lost her mind( started to behave like someone on drugs ); had  big open sores on back of her hands; patient didn't receive the second dose; " her mouth is mess"/developed rashes in mouth and lips; developed rashes in lips; developed rashes on her upper body; This spontaneous case was reported by a consumer (subsequently medically confirmed) and describes the occurrence of FEELING ABNORMAL (the patient lost her mind( started to behave like someone on drugs )), SKIN ULCER (had  big open sores on back of her hands), PRODUCT DOSE OMISSION ISSUE (patient didn't receive the second dose), ORAL MUCOSAL ERUPTION (" her mouth is mess"/developed rashes in mouth and lips) and CHEILITIS (developed rashes in lips) in a 59-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.    On 01-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced FEELING ABNORMAL (the patient lost her mind( started to behave like someone on drugs )), SKIN ULCER (had  big open sores on back of her hands), PRODUCT DOSE OMISSION ISSUE (patient didn't receive the second dose), ORAL MUCOSAL ERUPTION (" her mouth is mess"/developed rashes in mouth and lips), CHEILITIS (developed rashes in lips) and RASH (developed rashes on her upper body). The patient was treated with PREDNISONE at an unspecified dose and frequency. At the time of the report, FEELING ABNORMAL (the patient lost her mind( started to behave like someone on drugs )), SKIN ULCER (had  big open sores on back of her hands), PRODUCT DOSE OMISSION ISSUE (patient didn't receive the second dose), ORAL MUCOSAL ERUPTION (" her mouth is mess"/developed rashes in mouth and lips), CHEILITIS (developed rashes in lips) and RASH (developed rashes on her upper body) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No concomitant medication was reported. Treatment included antibiotics and topical steroids
Age: 73.0
Sex: F
Vaccine: COVID19
Symptoms: Influenza like illness, Pyrexia
Clinical narrative: flu-like symptoms; fever; This spontaneous case was reported by a nurse and describes the occurrence of INFLUENZA LIKE ILLNESS (flu-like symptoms) and PYREXIA (fever) in a 73-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 028L20A) for COVID-19 vaccination.     The patient's past medical history included Hysterectomy. Concomitant products included ESTRADIOL (ESTROGEN) for Hysterectomy, VITAMINS NOS for an unknown indication.    On 18-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 18-Jan-2021, the patient experienced INFLUENZA LIKE ILLNESS (flu-like symptoms) and PYREXIA (fever). The patient was treated with PREDNISONE at a dose of 20 mg twice a day. On 19-Jan-2021, INFLUENZA LIKE ILLNESS (flu-like symptoms) and PYREXIA (fever) 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.   Treatment medications include Topical Cream.   This case was linked to MOD-2021-251767 (Patient Link).
Sex: F
Vaccine: COVID19
Symptoms: Headache
Clinical narrative: headache on the right side of the head and above the eye; This spontaneous case was reported by a consumer and describes the occurrence of HEADACHE (headache on the right side of the head and above the eye) in an 81-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 012M20A) for COVID-19 vaccination.     Concurrent medical conditions included Milk allergy. Concomitant products included AMLODIPINE for BP raised, CALCIUM CITRATE for an unknown indication.    On 12-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 HEADACHE (headache on the right side of the head and above the eye). At the time of the report, HEADACHE (headache on the right side of the head and above the eye) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       This case was linked to MOD-2021-251199 (Patient Link).   Most recent FOLLOW-UP information incorporated above includes: On 03-Aug-2021: Follow up received and contains second dose information
Sex: F
Vaccine: COVID19
Symptoms: Abdominal discomfort, Anxiety, Dyspnoea, Panic reaction
Clinical narrative: stomach issues; anxiety; cannot breathe; panicking about not being able to breathe; This spontaneous case was reported by a consumer and describes the occurrence of ABDOMINAL DISCOMFORT (stomach issues), ANXIETY (anxiety), DYSPNOEA (cannot breathe) and PANIC REACTION (panicking about not being able to breathe) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On an unknown date, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced ABDOMINAL DISCOMFORT (stomach issues), ANXIETY (anxiety), DYSPNOEA (cannot breathe) and PANIC REACTION (panicking about not being able to breathe). At the time of the report, ABDOMINAL DISCOMFORT (stomach issues), ANXIETY (anxiety), DYSPNOEA (cannot breathe) and PANIC REACTION (panicking about not being able to breathe) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No concomitant medications were reported. No treatment details were reported.   This case was linked to MOD-2021-251573 (Patient Link).
Age: 69.0
Sex: F
Vaccine: COVID19
Symptoms: Blood pressure measurement, Dyspnoea
Clinical narrative: Shortness of breath; This spontaneous case was reported by a consumer and describes the occurrence of DYSPNOEA (Shortness of breath) in a 69-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 078C21A) for COVID-19 vaccination.     No medical history was provided by the reporter.  Concomitant products included LEVOTHYROXINE, METOPROLOL, BUSPIRONE and LORAZEPAM for an unknown indication.    On 07-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 DYSPNOEA (Shortness of breath). At the time of the report, DYSPNOEA (Shortness of breath) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, Blood pressure measurement: high (High) higher blood pressure.     The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       The patient had scheduled there second dose on 4 Aug.  Treatment Lorazepam 0.5 mg. The patient usually took it twice a day. this time took a third one at midnight.
Age: 56.0
Sex: M
Vaccine: COVID19
Symptoms: Blister, Rash
Clinical narrative: rash on my thighs and arms/rash moves to another area; blisters hands, fingers, toes, feet, knees, and elbows; This spontaneous case was reported by an other health care professional and describes the occurrence of BLISTER (blisters hands, fingers, toes, feet, knees, and elbows) and RASH (rash on my thighs and arms/rash moves to another area) in a 56-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On 14-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 04-Jul-2021, the patient experienced BLISTER (blisters hands, fingers, toes, feet, knees, and elbows). On an unknown date, the patient experienced RASH (rash on my thighs and arms/rash moves to another area). At the time of the report, BLISTER (blisters hands, fingers, toes, feet, knees, and elbows) and RASH (rash on my thighs and arms/rash moves to another area) outcome was unknown.        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 details was reported. The patient saw his HCP on 06Jul2021. Doctor prescribed him an anti-fungal medication, but he has not used it.
Sex: U
Vaccine: COVID19
Symptoms: Blood pressure fluctuation, Cardiac discomfort
Clinical narrative: Heart feels like there is a lump around it; Blood pressure is up and down; This spontaneous case was reported by a consumer and describes the occurrence of CARDIAC DISCOMFORT (Heart feels like there is a lump around it) and BLOOD PRESSURE FLUCTUATION (Blood pressure is up and down) 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 CARDIAC DISCOMFORT (Heart feels like there is a lump around it) and BLOOD PRESSURE FLUCTUATION (Blood pressure is up and down). At the time of the report, CARDIAC DISCOMFORT (Heart feels like there is a lump around it) and BLOOD PRESSURE FLUCTUATION (Blood pressure is up and down) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No concomitant medications were reported. Treatment information was not provided by the reporter.
Sex: U
Vaccine: COVID19
Symptoms: Ageusia, Anosmia
Clinical narrative: Loss of taste; Loss of smell; 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 AGEUSIA (Loss of taste) and ANOSMIA (Loss of smell) 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 AGEUSIA (Loss of taste) and ANOSMIA (Loss of smell). At the time of the report, AGEUSIA (Loss of taste) and ANOSMIA (Loss of smell) outcome was unknown. Not provided.     The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No concomitant medications reported by investigator  No treatment medications provided by the reporter.
Sex: U
Vaccine: COVID19
Symptoms: Expired product administered
Clinical narrative: Expired Vaccine administered to 18 patients; 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 (Expired Vaccine administered to 18 patients) in a patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 034C21A) for COVID-19 vaccination.     patient information was not reported patient medical history information was not reported.     In 2021, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 24-Jun-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (Expired Vaccine administered to 18 patients).        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 was reported. No treatment medication was reported. Moderna cannot guarantee patients received full protection against the COVID-19 Virus   Most recent FOLLOW-UP information incorporated above includes: On 26-Jul-2021: Non Significant Followup - Patient Reported No Adverse Event. On 28-Jul-2021: Follow Up Information received on 28 Jul 2021, contains NNI
Sex: U
Vaccine: COVID19
Symptoms: Ocular discomfort, Pharyngeal swelling, Rash, Swelling face
Clinical narrative: My face started swelling./ Swelling kept getting worse.; Eye was completely closed; Throat started to swell; My face started swelling. With a rash.; 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 SWELLING FACE (My face started swelling./ Swelling kept getting worse.), OCULAR DISCOMFORT (Eye was completely closed), PHARYNGEAL SWELLING (Throat started to swell) and RASH (My face started swelling. With a rash.) 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 SWELLING FACE (My face started swelling./ Swelling kept getting worse.), OCULAR DISCOMFORT (Eye was completely closed), PHARYNGEAL SWELLING (Throat started to swell) and RASH (My face started swelling. With a rash.). At the time of the report, SWELLING FACE (My face started swelling./ Swelling kept getting worse.), OCULAR DISCOMFORT (Eye was completely closed), PHARYNGEAL SWELLING (Throat started to swell) and RASH (My face started swelling. With a rash.) outcome was unknown. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown Route) was unknown.       No concominant medications were reported. No treatment information was received.   Most recent FOLLOW-UP information incorporated above includes: On 20-Aug-2021: No new information recieved
Sex: U
Vaccine: COVID19
Symptoms: Product dose omission issue
Clinical narrative: Not taking 2 dose of vaccine; This spontaneous case was reported by a consumer and describes the occurrence of PRODUCT DOSE OMISSION ISSUE (Not taking 2 dose of 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 first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced PRODUCT DOSE OMISSION ISSUE (Not taking 2 dose of vaccine). At the time of the report, PRODUCT DOSE OMISSION ISSUE (Not taking 2 dose of vaccine) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.
Age: 38.0
Sex: F
Vaccine: COVID19
Symptoms: Product dose omission issue
Clinical narrative: More than recommended interval from the first dose on 21 May 2021; This spontaneous case was reported by a pharmacist and describes the occurrence of PRODUCT DOSE OMISSION ISSUE (More than recommended interval from the first dose on 21 May 2021) in a 38-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On 21-May-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 21-May-2021, the patient experienced PRODUCT DOSE OMISSION ISSUE (More than recommended interval from the first dose on 21 May 2021). On 21-May-2021, PRODUCT DOSE OMISSION ISSUE (More than recommended interval from the first dose on 21 May 2021) 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.   Concomitant medications details were not reported by the reporter. Treatment details was not reported by the reporter.
Age: 14.0
Sex: F
Vaccine: COVID19
Symptoms: Product administered to patient of inappropriate age
Clinical narrative: received Moderna Covid-19 Vaccine at the age of 14 years old; This spontaneous case was reported by a nurse and describes the occurrence of PRODUCT ADMINISTERED TO PATIENT OF INAPPROPRIATE AGE (received Moderna Covid-19 Vaccine at the age of 14 years old) in a 14-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 047C21A) for COVID-19 vaccination.     No Medical History information was reported.    On 05-Jul-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 05-Jul-2021, the patient experienced PRODUCT ADMINISTERED TO PATIENT OF INAPPROPRIATE AGE (received Moderna Covid-19 Vaccine at the age of 14 years old).        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: 42.0
Sex: F
Vaccine: COVID19
Symptoms: Abdominal discomfort, Chills, Diarrhoea, Fatigue, Feeling cold
Clinical narrative: Sweats; Diarrhea; Felt like a bad cold/flu.; Exhaustion; ill; Stomach upset; Vomiting; Chills; Fever; This spontaneous case was reported by a consumer and describes the occurrence of ILLNESS (ill), PYREXIA (Fever), VOMITING (Vomiting), ABDOMINAL DISCOMFORT (Stomach upset) and CHILLS (Chills) in a 42-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 020B21A and 003B21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     Concurrent medical conditions included Epilepsy since 30-Jun-2015, Sulfonamide allergy (Sulfa), Drug allergy (Gabapentin) and Food allergy (Bananas). Concomitant products included PREGABALIN (LYRICA) for Epilepsy.   On 30-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 27-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 27-Apr-2021, the patient experienced PYREXIA (Fever), VOMITING (Vomiting), ABDOMINAL DISCOMFORT (Stomach upset) and CHILLS (Chills). On an unknown date, the patient experienced ILLNESS (ill), HYPERHIDROSIS (Sweats), FATIGUE (Exhaustion), DIARRHOEA (Diarrhea) and FEELING COLD (Felt like a bad cold/flu.). On 07-May-2021, PYREXIA (Fever), VOMITING (Vomiting), ABDOMINAL DISCOMFORT (Stomach upset) and CHILLS (Chills) had resolved. At the time of the report, ILLNESS (ill), HYPERHIDROSIS (Sweats), FATIGUE (Exhaustion), DIARRHOEA (Diarrhea) and FEELING COLD (Felt like a bad cold/flu.) outcome was unknown.            No Treatment information was provided.   This case was linked to MOD-2021-069831 (Patient Link).
Age: 42.0
Sex: F
Vaccine: COVID19
Symptoms: Hyperhidrosis, Illness, Pyrexia, Vomiting
Clinical narrative: Sweats; Diarrhea; Felt like a bad cold/flu.; Exhaustion; ill; Stomach upset; Vomiting; Chills; Fever; This spontaneous case was reported by a consumer and describes the occurrence of ILLNESS (ill), PYREXIA (Fever), VOMITING (Vomiting), ABDOMINAL DISCOMFORT (Stomach upset) and CHILLS (Chills) in a 42-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 020B21A and 003B21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     Concurrent medical conditions included Epilepsy since 30-Jun-2015, Sulfonamide allergy (Sulfa), Drug allergy (Gabapentin) and Food allergy (Bananas). Concomitant products included PREGABALIN (LYRICA) for Epilepsy.   On 30-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 27-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 27-Apr-2021, the patient experienced PYREXIA (Fever), VOMITING (Vomiting), ABDOMINAL DISCOMFORT (Stomach upset) and CHILLS (Chills). On an unknown date, the patient experienced ILLNESS (ill), HYPERHIDROSIS (Sweats), FATIGUE (Exhaustion), DIARRHOEA (Diarrhea) and FEELING COLD (Felt like a bad cold/flu.). On 07-May-2021, PYREXIA (Fever), VOMITING (Vomiting), ABDOMINAL DISCOMFORT (Stomach upset) and CHILLS (Chills) had resolved. At the time of the report, ILLNESS (ill), HYPERHIDROSIS (Sweats), FATIGUE (Exhaustion), DIARRHOEA (Diarrhea) and FEELING COLD (Felt like a bad cold/flu.) outcome was unknown.            No Treatment information was provided.   This case was linked to MOD-2021-069831 (Patient Link).
Sex: U
Vaccine: COVID19
Symptoms: Product dose omission issue
Clinical narrative: Past the 42 day mark; 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 PRODUCT DOSE OMISSION ISSUE (Past the 42 day mark) 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 26-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 26-Mar-2021, the patient experienced PRODUCT DOSE OMISSION ISSUE (Past the 42 day mark). On 26-Mar-2021, PRODUCT DOSE OMISSION ISSUE (Past the 42 day mark) 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.   Concomitant product use was not provided. Treatment information was not provided.
Age: 58.0
Sex: F
Vaccine: COVID19
Symptoms: Erythema, Swelling, Vaccination site erythema
Clinical narrative: black bump / swollen; redness; "blue and red" way up around the injection site; This spontaneous case was reported by a consumer and describes the occurrence of SWELLING (black bump / swollen), ERYTHEMA (redness) and VACCINATION SITE ERYTHEMA ("blue and red" way up around the injection site) in a 58-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 040B21A) for COVID-19 vaccination.     No Medical History information was reported.    On 10-Jun-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 SWELLING (black bump / swollen), ERYTHEMA (redness) and VACCINATION SITE ERYTHEMA ("blue and red" way up around the injection site). At the time of the report, SWELLING (black bump / swollen), ERYTHEMA (redness) and VACCINATION SITE ERYTHEMA ("blue and red" way up around the injection site) 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.
Sex: U
Vaccine: COVID19
Symptoms: Expired product administered
Clinical narrative: 4 patients received a vaccine from a syringe that had been at room temperature for approximately; 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 (4 patients received a vaccine from a syringe that had been at room temperature for approximately) in a patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No specified medical history has been reported .     On an unknown date, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 08-Jul-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (4 patients received a vaccine from a syringe that had been at room temperature for approximately). At the time of the report, EXPIRED PRODUCT ADMINISTERED (4 patients received a vaccine from a syringe that had been at room temperature for approximately) outcome was unknown. Not Provided      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.   Concomitant medications was not provided. Treatment information was not provided.
Sex: U
Vaccine: COVID19
Symptoms: Expired product administered
Clinical narrative: received vaccine past it's beyond use date.; Based on the current case data, this case has been classified as invalid. This spontaneous case was reported by an other health care professional and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (received vaccine past it's beyond use date.) in an adult patient of an unknown gender who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 047C21A) for COVID-19 vaccination.     No Medical History information was reported.    On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced EXPIRED PRODUCT ADMINISTERED (received vaccine past it's beyond use date.). At the time of the report, EXPIRED PRODUCT ADMINISTERED (received vaccine past it's beyond use date.) 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.   Clinical Team Supervisor called to report that she has Moderna COVID-19 vaccine that was placed in the refrigerator on 01-JUN-2021. 30 days came and went and after 01-JUL-2021 the vaccine was used to immunize 3 patients.  All 3 patients are adults. The expired Moderna Covid-19 vaccine was administered sometime between July 6 and July 8.  Concomitant medication not provided.  Treatment information not provided.
Sex: U
Vaccine: COVID19
Symptoms: Product dose omission issue
Clinical narrative: hasbeen over 10 weeks since the first dose; This spontaneous case was reported by a consumer and describes the occurrence of PRODUCT DOSE OMISSION ISSUE (hasbeen over 10 weeks since the first dose) 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 24-Apr-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 PRODUCT DOSE OMISSION ISSUE (hasbeen over 10 weeks since the first dose). At the time of the report, PRODUCT DOSE OMISSION ISSUE (hasbeen over 10 weeks since the first dose) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No concomitant product reported by reporter. No treatment medication reported by reporter. Patient stated that patient did not go to receive the second dose because patient did not have a ride to go to the clinic. Patient declined providing additional details. Patient did not confirmed gender.     Reporter did not allow further contact
Sex: U
Vaccine: COVID19
Symptoms: Fatigue, Headache
Clinical narrative: fatigue; headaches; 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 FATIGUE (fatigue) and HEADACHE (headaches) in a patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced FATIGUE (fatigue) and HEADACHE (headaches). At the time of the report, FATIGUE (fatigue) and HEADACHE (headaches) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Concomitant medications were not provided. Treatment information was not provided.
Sex: U
Vaccine: COVID19
Symptoms: Expired product administered
Clinical narrative: Expired Vaccine administered to 28 patients; 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 (Expired Vaccine administered to 28 patients) in a patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 035C21A) for COVID-19 vaccination.     No Medical History information was reported.    In June 2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. In June 2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (Expired Vaccine administered to 28 patients). In June 2021, EXPIRED PRODUCT ADMINISTERED (Expired Vaccine administered to 28 patients) 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.
Age: 39.0
Sex: F
Vaccine: COVID19
Symptoms: Fatigue, Vaccination site pain
Clinical narrative: arm was sore; tired/very tired; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE PAIN (arm was sore) and FATIGUE (tired/very tired) in a 39-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 027C21A) for COVID-19 vaccination.     Concurrent medical conditions included Lyme's disease, Fibromyalgia and Blood pressure high. Concomitant products included CLONAZEPAM, LISINOPRIL and PAROXETINE for an unknown indication.    On 14-May-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 14-May-2021, the patient experienced VACCINATION SITE PAIN (arm was sore) and FATIGUE (tired/very tired). In May 2021, VACCINATION SITE PAIN (arm was sore) had resolved. At the time of the report, FATIGUE (tired/very tired) outcome was unknown.        mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosing remained unchanged.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   No treatment medication was provided.   This case was linked to MOD-2021-251831 (Patient Link).   Most recent FOLLOW-UP information incorporated above includes: On 06-Aug-2021: Follow-up information include  action taken reassessed from unknown to no change and outcome of pain in arm updated from unknown  to resolved  which was missed to be captured in initial version and narrative updated