chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 18.0
Sex: F
Vaccine: COVID19
Symptoms: Suspected COVID-19
Clinical narrative: Maybe had covid; lethargic; achy; Major abnormality positive for Epstein Barr virus identified; Incredibly fatigued; General malaise; This spontaneous case was reported by a consumer and describes the occurrence of MALAISE (General malaise), SUSPECTED COVID-19 (Maybe had covid), LETHARGY (lethargic), EPSTEIN-BARR VIRUS TEST POSITIVE (Major abnormality positive for Epstein Barr virus identified) and MYALGIA (achy) in an 18-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 027C21A and 033B21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     Concomitant products included Loratadine (Claritin) for an unknown indication.   On 19-May-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 16-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 MALAISE (General malaise) and FATIGUE (Incredibly fatigued). On 02-Jul-2021, the patient experienced EPSTEIN-BARR VIRUS TEST POSITIVE (Major abnormality positive for Epstein Barr virus identified). On an unknown date, the patient experienced SUSPECTED COVID-19 (Maybe had covid), LETHARGY (lethargic) and MYALGIA (achy). The patient was treated with PARACETAMOL (TYLENOL) at an unspecified dose and frequency and IBUPROFEN (ADVIL [IBUPROFEN]) at an unspecified dose and frequency. At the time of the report, MALAISE (General malaise) and FATIGUE (Incredibly fatigued) had not resolved and SUSPECTED COVID-19 (Maybe had covid), LETHARGY (lethargic), EPSTEIN-BARR VIRUS TEST POSITIVE (Major abnormality positive for Epstein Barr virus identified) and MYALGIA (achy) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   On 24-jun-2021 patient's mother took her daughter to the pediatrician and he confirmed that the patient may have COVID so she had a lengthy response to vaccine. on 30-jun-2021 her mother also stated that she had not improved at all and which was the biggest complaint that that there was no improvement at day 14.  Action taken with mRNA-1273 in response to the events was not applicable.   Most recent FOLLOW-UP information incorporated above includes: On 30-Jun-2021: Significant follow-up added on 30-JUN-2021 and updated reporter information, patient  initials,age at vaccination,  start date of both doses of vaccine , batch number and anatomical location of vaccine administered , concomitant, treatment medications, events and outcome of the event were added. On 06-Jul-2021: Significant follow up received on 06-Jul-2021, new event added.
Sex: U
Vaccine: COVID19
Symptoms: Myalgia, Peripheral swelling
Clinical narrative: bump on my arm after taking the vaccine; arm hurts after 4 days; This spontaneous case was reported by a consumer and describes the occurrence of PERIPHERAL SWELLING (bump on my arm after taking the vaccine) and MYALGIA (arm hurts after 4 days) 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 20-Jun-2021, the patient experienced PERIPHERAL SWELLING (bump on my arm after taking the vaccine) and MYALGIA (arm hurts after 4 days). At the time of the report, PERIPHERAL SWELLING (bump on my arm after taking the vaccine) and MYALGIA (arm hurts after 4 days) 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.   Reporter did not allow further contact
Age: 51.0
Sex: F
Vaccine: COVID19
Symptoms: Headache, Pruritus, Somnolence, Vaccination site erythema, Vaccination site induration
Clinical narrative: Hot; All she could do was sleep; Itchy; Spot is hard; Swollen; Covid arm where it is a little red circle that grew 3-4 inches in diameter; Sore to the touch; Headache; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE WARMTH (Hot), SOMNOLENCE (All she could do was sleep), PRURITUS (Itchy), VACCINATION SITE INDURATION (Spot is hard) and VACCINATION SITE SWELLING (Swollen) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 006C21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.    On 17-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 VACCINATION SITE WARMTH (Hot), SOMNOLENCE (All she could do was sleep), PRURITUS (Itchy), VACCINATION SITE INDURATION (Spot is hard), VACCINATION SITE SWELLING (Swollen), VACCINATION SITE ERYTHEMA (Covid arm where it is a little red circle that grew 3-4 inches in diameter), VACCINATION SITE PAIN (Sore to the touch) and HEADACHE (Headache). At the time of the report, VACCINATION SITE WARMTH (Hot), SOMNOLENCE (All she could do was sleep), PRURITUS (Itchy), VACCINATION SITE INDURATION (Spot is hard), VACCINATION SITE SWELLING (Swollen), VACCINATION SITE ERYTHEMA (Covid arm where it is a little red circle that grew 3-4 inches in diameter), VACCINATION SITE PAIN (Sore to the touch) and HEADACHE (Headache) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No relevant concomitant medications were reported.  No treatment information was provided.
Age: 51.0
Sex: F
Vaccine: COVID19
Symptoms: Vaccination site pain, Vaccination site swelling, Vaccination site warmth
Clinical narrative: Hot; All she could do was sleep; Itchy; Spot is hard; Swollen; Covid arm where it is a little red circle that grew 3-4 inches in diameter; Sore to the touch; Headache; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE WARMTH (Hot), SOMNOLENCE (All she could do was sleep), PRURITUS (Itchy), VACCINATION SITE INDURATION (Spot is hard) and VACCINATION SITE SWELLING (Swollen) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 006C21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.    On 17-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 VACCINATION SITE WARMTH (Hot), SOMNOLENCE (All she could do was sleep), PRURITUS (Itchy), VACCINATION SITE INDURATION (Spot is hard), VACCINATION SITE SWELLING (Swollen), VACCINATION SITE ERYTHEMA (Covid arm where it is a little red circle that grew 3-4 inches in diameter), VACCINATION SITE PAIN (Sore to the touch) and HEADACHE (Headache). At the time of the report, VACCINATION SITE WARMTH (Hot), SOMNOLENCE (All she could do was sleep), PRURITUS (Itchy), VACCINATION SITE INDURATION (Spot is hard), VACCINATION SITE SWELLING (Swollen), VACCINATION SITE ERYTHEMA (Covid arm where it is a little red circle that grew 3-4 inches in diameter), VACCINATION SITE PAIN (Sore to the touch) and HEADACHE (Headache) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No relevant concomitant medications were reported.  No treatment information was provided.
Age: 83.0
Sex: F
Vaccine: COVID19
Symptoms: Disturbance in social behaviour, Feeling abnormal, Groin pain, Impaired driving ability, Joint injury
Clinical narrative: my muscles were so weak; it has been hell; I took a fall on my knee; now I can not drive; now I can not get around at all; twisted groin muscle pain; it feels sore; twisted groin muscle pain; This spontaneous case was reported by a patient and describes the occurrence of the first episode of GROIN PAIN (twisted groin muscle pain), MUSCULAR WEAKNESS (my muscles were so weak), FEELING ABNORMAL (it has been hell), JOINT INJURY (I took a fall on my knee) and IMPAIRED DRIVING ABILITY (now I can not drive) in an 83-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 027A21A and 019M209) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.   On 16-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 16-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 24-Feb-2021, the patient experienced the first episode of GROIN PAIN (twisted groin muscle pain). On 30-Mar-2021, the patient experienced MUSCULAR WEAKNESS (my muscles were so weak), FEELING ABNORMAL (it has been hell), JOINT INJURY (I took a fall on my knee), IMPAIRED DRIVING ABILITY (now I can not drive), DISTURBANCE IN SOCIAL BEHAVIOUR (now I can not get around at all), the second episode of GROIN PAIN (twisted groin muscle pain) and MYALGIA (it feels sore). At the time of the report, MUSCULAR WEAKNESS (my muscles were so weak), FEELING ABNORMAL (it has been hell), JOINT INJURY (I took a fall on my knee), IMPAIRED DRIVING ABILITY (now I can not drive), DISTURBANCE IN SOCIAL BEHAVIOUR (now I can not get around at all), the last episode of GROIN PAIN (twisted groin muscle pain) and MYALGIA (it feels sore) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant medications were provided by the reporter. No treatment medications were provided by the reporter   This case was linked to MOD-2021-230003 (Patient Link).
Age: 83.0
Sex: F
Vaccine: COVID19
Symptoms: Muscular weakness, Myalgia
Clinical narrative: my muscles were so weak; it has been hell; I took a fall on my knee; now I can not drive; now I can not get around at all; twisted groin muscle pain; it feels sore; twisted groin muscle pain; This spontaneous case was reported by a patient and describes the occurrence of the first episode of GROIN PAIN (twisted groin muscle pain), MUSCULAR WEAKNESS (my muscles were so weak), FEELING ABNORMAL (it has been hell), JOINT INJURY (I took a fall on my knee) and IMPAIRED DRIVING ABILITY (now I can not drive) in an 83-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 027A21A and 019M209) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.   On 16-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 16-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 24-Feb-2021, the patient experienced the first episode of GROIN PAIN (twisted groin muscle pain). On 30-Mar-2021, the patient experienced MUSCULAR WEAKNESS (my muscles were so weak), FEELING ABNORMAL (it has been hell), JOINT INJURY (I took a fall on my knee), IMPAIRED DRIVING ABILITY (now I can not drive), DISTURBANCE IN SOCIAL BEHAVIOUR (now I can not get around at all), the second episode of GROIN PAIN (twisted groin muscle pain) and MYALGIA (it feels sore). At the time of the report, MUSCULAR WEAKNESS (my muscles were so weak), FEELING ABNORMAL (it has been hell), JOINT INJURY (I took a fall on my knee), IMPAIRED DRIVING ABILITY (now I can not drive), DISTURBANCE IN SOCIAL BEHAVIOUR (now I can not get around at all), the last episode of GROIN PAIN (twisted groin muscle pain) and MYALGIA (it feels sore) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant medications were provided by the reporter. No treatment medications were provided by the reporter   This case was linked to MOD-2021-230003 (Patient Link).
Sex: U
Vaccine: COVID19
Symptoms: Pyrexia
Clinical narrative: Is a fever a normal side effect; This spontaneous case was reported by a consumer and describes the occurrence of PYREXIA (Is a fever a normal side effect) 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 PYREXIA (Is a fever a normal side effect). At the time of the report, PYREXIA (Is a fever a normal side effect) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No relevant concomitant medications reported.  No treatment information was provided.
Age: 38.0
Sex: M
Vaccine: COVID19
Symptoms: Nausea, Vomiting
Clinical narrative: Nausea; Vomiting; This spontaneous case was reported by a consumer and describes the occurrence of NAUSEA (Nausea) and VOMITING (Vomiting) in a 38-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     Concomitant products included PARACETAMOL (TYLENOL) for an unknown indication.   On 29-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 25-Apr-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 NAUSEA (Nausea) and VOMITING (Vomiting). At the time of the report, NAUSEA (Nausea) and VOMITING (Vomiting) outcome was unknown.            The patient had came into contact with the COVID-19 virus early.  No treatment information was provided.  The patient received both scheduled doses of mRNA-1273 prior to the events therefore, action taken with the drug in response to the events was not applicable.   This case was linked to MOD-2021-103013 (E2B Linked Report).; Sender's Comments:  MOD-2021-103013:Mother case (MOD21-085901)
Sex: U
Vaccine: COVID19
Symptoms: Diarrhoea
Clinical narrative: Can Moderna Vaccine cause diarhea/Can it cause diahrea"; This spontaneous case was reported by a consumer and describes the occurrence of DIARRHOEA (Can Moderna Vaccine cause diarhea/Can it cause diahrea") 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 DIARRHOEA (Can Moderna Vaccine cause diarhea/Can it cause diahrea"). At the time of the report, DIARRHOEA (Can Moderna Vaccine cause diarhea/Can it cause diahrea") outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       Concomitant medications were not provided. Treatment information was not provided.   Most recent FOLLOW-UP information incorporated above includes: On 09-Aug-2021: Follow-up included no new information.
Age: 36.0
Sex: M
Vaccine: COVID19
Symptoms: Myalgia
Clinical narrative: my arm hurt; This spontaneous case was reported by a non-health professional and describes the occurrence of MYALGIA (my arm hurt) in a 36-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 006C21A and 006C21A) for COVID-19 vaccination.     Concurrent medical conditions included Epilepsy. Concomitant products included LORAZEPAM (ATIVAN) for Epilepsy, CARBAMAZEPINE (TEGRETOL) and CLOBAZAM for an unknown indication.   On 12-May-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 16-Jun-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 MYALGIA (my arm hurt). At the time of the report, MYALGIA (my arm hurt) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No treatment medication were provided.  Patient  provided he has a history of Epilepsy, but normally has  lot of energy. He stated he took his pre-workout mix and was still needing to take naps, usually gives him a lot of energy.   This case was linked to MOD-2021-230006 (Patient Link).
Age: 66.0
Sex: F
Vaccine: COVID19
Symptoms: Skin plaque
Clinical narrative: small scaly plaque developed on her body (possibly chest per HCP); This spontaneous case was reported by a nurse and describes the occurrence of SKIN PLAQUE (small scaly plaque developed on her body (possibly chest per HCP)) in a 66-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 047A21A) for COVID-19 vaccination.     No Medical History information was reported.    On 16-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 16-Mar-2021, the patient experienced SKIN PLAQUE (small scaly plaque developed on her body (possibly chest per HCP)). At the time of the report, SKIN PLAQUE (small scaly plaque developed on her body (possibly chest per HCP)) 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.   Concomitant medication not provided.  Treatment information not provided.   This case was linked to MOD-2021-230017 (Patient Link).
Age: 21.0
Sex: F
Vaccine: COVID19
Symptoms: Back pain, Myalgia
Clinical narrative: lower back pain; Consistent lower back pain/ muscle pain in her lower back; This spontaneous case was reported by a consumer and describes the occurrence of BACK PAIN (lower back pain) and MYALGIA (Consistent lower back pain/ muscle pain in her lower back) in a 21-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 048B21A and 026B21A) for COVID-19 vaccination.     Concurrent medical conditions included Seizure (Patient was born with a genetic disease called Turborosis Seizure complex, she is physically and mentally disabled.). Concomitant products included LAMOTRIGINE for an unknown indication.   On 31-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 28-Apr-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 BACK PAIN (lower back pain) and MYALGIA (Consistent lower back pain/ muscle pain in her lower back). The patient was treated with PARACETAMOL (TYLENOL) for Muscle pain, at an unspecified dose and frequency and IBUPROFEN (ADVIL [IBUPROFEN]) for Muscle pain, at an unspecified dose and frequency. At the time of the report, BACK PAIN (lower back pain) and MYALGIA (Consistent lower back pain/ muscle pain in her lower back) outcome was unknown.            After 1st dose patient experienced a mild soreness in the arm, but after 2nd dose of vaccine patient experienced consistent muscle pain in her lower back and it was so painful that she had to take medications every 5 to 6 hours. Patient had gone to the ER and urgent care and they couldn't pinpoint what is going on.
Age: 83.0
Sex: F
Vaccine: COVID19
Symptoms: Fall, Groin pain, Muscular weakness, Myalgia, Tendonitis
Clinical narrative: Tendonitis in knee; It feels sore; Twisted groin muscle pain again; My muscles were so weak; I took a fall on my knee; This spontaneous case was reported by a consumer and describes the occurrence of GROIN PAIN (Twisted groin muscle pain again), MUSCULAR WEAKNESS (My muscles were so weak), FALL (I took a fall on my knee), TENDONITIS (Tendonitis in knee) and MYALGIA (It feels sore) in an 83-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 027A21A) for COVID-19 vaccination.     No Medical History information was reported.   On 16-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 16-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 30-Mar-2021, the patient experienced GROIN PAIN (Twisted groin muscle pain again), MUSCULAR WEAKNESS (My muscles were so weak), FALL (I took a fall on my knee) and MYALGIA (It feels sore). On an unknown date, the patient experienced TENDONITIS (Tendonitis in knee). At the time of the report, GROIN PAIN (Twisted groin muscle pain again), MUSCULAR WEAKNESS (My muscles were so weak), FALL (I took a fall on my knee), TENDONITIS (Tendonitis in knee) and MYALGIA (It feels sore) outcome was unknown.            No concomitants were reported. No treatment was reported.   This case was linked to MOD-2021-229992 (Patient Link).
Sex: U
Vaccine: COVID19
Symptoms: Vaccination site erythema, Vaccination site mass, Vaccination site warmth
Clinical narrative: big knot where the shot was done; red; really hot; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE MASS (big knot where the shot was done), VACCINATION SITE ERYTHEMA (red) and VACCINATION SITE WARMTH (really hot) in a patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced VACCINATION SITE MASS (big knot where the shot was done), VACCINATION SITE ERYTHEMA (red) and VACCINATION SITE WARMTH (really hot). At the time of the report, VACCINATION SITE MASS (big knot where the shot was done), VACCINATION SITE ERYTHEMA (red) and VACCINATION SITE WARMTH (really hot) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No concomitant products reported. No treatment products reported.
Age: 36.0
Sex: M
Vaccine: COVID19
Symptoms: Asthenia, Cold sweat, Dizziness, Nausea, Somnolence
Clinical narrative: I've been puking, feeling of puking; sweating cold; dizzy; no energy at all; still needing to take naps; This spontaneous case was reported by a consumer and describes the occurrence of COLD SWEAT (sweating cold), DIZZINESS (dizzy), ASTHENIA (no energy at all), SOMNOLENCE (still needing to take naps) and NAUSEA (I've been puking, feeling of puking) in a 36-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 006C21A and 006C21A) for COVID-19 vaccination.     The patient's past medical history included Epilepsy. Concomitant products included LORAZEPAM (ATIVAN), CARBAMAZEPINE (TEGRETOL) and CLOBAZAM for Epilepsy.   On 12-May-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 16-Jun-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 17-Jun-2021, the patient experienced COLD SWEAT (sweating cold), DIZZINESS (dizzy), ASTHENIA (no energy at all) and SOMNOLENCE (still needing to take naps). On 17-Jun-2021 at 10:00 AM, the patient experienced NAUSEA (I've been puking, feeling of puking). On 20-Jun-2021, COLD SWEAT (sweating cold) had resolved. At the time of the report, DIZZINESS (dizzy), ASTHENIA (no energy at all), SOMNOLENCE (still needing to take naps) and NAUSEA (I've been puking, feeling of puking) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown Route), the reporter did not provide any causality assessments.   Treatment information was unknown
Age: 44.0
Sex: F
Vaccine: COVID19
Symptoms: Inappropriate schedule of product administration, Poor quality product administered
Clinical narrative: Patient received second dose in less than 25 days after first dose; Vaccine had been in the refrigerator 33 days; This spontaneous case was reported by a physician and describes the occurrence of INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Patient received second dose in less than 25 days after first dose) and POOR QUALITY PRODUCT ADMINISTERED (Vaccine had been in the refrigerator 33 days) in a 44-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 003C21A) for COVID-19 vaccination.     No Medical History information was reported.   On 28-May-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 21-Jun-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 21-May-2021,  after starting mRNA-1273 (Moderna COVID-19 Vaccine), the patient experienced POOR QUALITY PRODUCT ADMINISTERED (Vaccine had been in the refrigerator 33 days). On 28-May-2021, the patient experienced INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Patient received second dose in less than 25 days after first dose). On 21-May-2021, POOR QUALITY PRODUCT ADMINISTERED (Vaccine had been in the refrigerator 33 days) had resolved. On 21-Jun-2021, INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Patient received second dose in less than 25 days after first dose) had resolved. Not Provided      For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   No treatment medications were provided. No concomitant medications information was reported. Action taken with mRNA-1273 in response to the events was not applicable.
Age: 27.0
Sex: M
Vaccine: COVID19
Symptoms: Tremor
Clinical narrative: Vicious shaking, almost like convulsions.
Age: 35.0
Sex: M
Vaccine: COVID19
Symptoms: Ageusia, Anosmia, Dizziness, Fatigue, Headache
Clinical narrative: Headaches, fatigue, productive cough, nasal congestion, loss of smell and taste, diminished hearing, excess sweating, dizziness.  Mild symptoms 24 hours post vaccine. Severe symptoms from 48 hours through day 6 post vaccine.
Age: 35.0
Sex: M
Vaccine: COVID19
Symptoms: Hyperhidrosis, Hypoacusis, Nasal congestion, Productive cough, SARS-CoV-2 test negative
Clinical narrative: Headaches, fatigue, productive cough, nasal congestion, loss of smell and taste, diminished hearing, excess sweating, dizziness.  Mild symptoms 24 hours post vaccine. Severe symptoms from 48 hours through day 6 post vaccine.
Sex: U
Vaccine: COVID19
Symptoms: Vaccination site bruising, Vaccination site pain
Clinical narrative: There is a like a red bruise thing that formed around where I got my shot; around where I got my shot and it hurts when I touch it; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE BRUISING (There is a like a red bruise thing that formed around where I got my shot) and VACCINATION SITE PAIN (around where I got my shot and it hurts when I touch it) in a patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced VACCINATION SITE BRUISING (There is a like a red bruise thing that formed around where I got my shot) and VACCINATION SITE PAIN (around where I got my shot and it hurts when I touch it). At the time of the report, VACCINATION SITE BRUISING (There is a like a red bruise thing that formed around where I got my shot) and VACCINATION SITE PAIN (around where I got my shot and it hurts when I touch it) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No Concomitant and  treatment medications were provided.   Most recent FOLLOW-UP information incorporated above includes: On 15-Jul-2021: Follow up received on 15-7-2021 contains no new information.
Sex: U
Vaccine: COVID19
Symptoms: Rash
Clinical narrative: body rashes; This spontaneous case was reported by a consumer and describes the occurrence of RASH (body rashes) 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 RASH (body rashes). At the time of the report, RASH (body rashes) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       Concomitant drug was not reported. Treatment medication was not reported.
Age: 73.0
Sex: M
Vaccine: COVID19
Symptoms: Inappropriate schedule of product administration
Clinical narrative: Second dose (Moderna Vaccine) given 4 months after first dose; This spontaneous case was reported by a physician and describes the occurrence of INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Second dose (Moderna Vaccine) given 4 months after first dose) in a 73-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     Concomitant products included PROPRANOLOL and CLONAZEPAM for an unknown indication.   In February 2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 15-Jun-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 15-Jun-2021, the patient experienced INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Second dose (Moderna Vaccine) given 4 months after first dose). On 15-Jun-2021, INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Second dose (Moderna Vaccine) given 4 months after first dose) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   No treatment medications are provided.
Sex: U
Vaccine: COVID19
Symptoms: Rash
Clinical narrative: Rash on face,arms, hands; This spontaneous case was reported by a consumer and describes the occurrence of RASH (rash on face,arms, hands) 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.   In March 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 RASH (rash on face,arms, hands). At the time of the report, RASH (rash on face,arms, hands) outcome was unknown.            No concomitant medications were reported. No treatment medications were reported.
Sex: U
Vaccine: COVID19
Symptoms: Product dose omission issue
Clinical narrative: Got my 1st dose in May and I haven't had time to go get my 2nd dose; This spontaneous case was reported by a consumer and describes the occurrence of PRODUCT DOSE OMISSION ISSUE (Got my 1st dose in May and I haven't had time to go get my 2nd 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 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 (Got my 1st dose in May and I haven't had time to go get my 2nd dose). At the time of the report, PRODUCT DOSE OMISSION ISSUE (Got my 1st dose in May and I haven't had time to go get my 2nd dose) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       The concomitant medications were not reported. The treatment information was not provided.
Age: 66.0
Sex: F
Vaccine: COVID19
Symptoms: Blood pressure measurement, Body temperature, Exfoliative rash, Oral mucosal eruption, Rash
Clinical narrative: rash spreading all the way to her mouth; rash on face; rash over arms; rash on leg; A scaly, red, peeling rash started to develop initially on her chest, spreading to her arm, upper back, legs on the interior side, spreading up her neck and face, spreading all the way to her mouth; This spontaneous case was reported by a nurse and describes the occurrence of EXFOLIATIVE RASH (A scaly, red, peeling rash started to develop initially on her chest, spreading to her arm, upper back, legs on the interior side, spreading up her neck and face, spreading all the way to her mouth), ORAL MUCOSAL ERUPTION (rash spreading all the way to her mouth), RASH (rash on face), RASH (rash over arms) and RASH (rash on leg) in a 66-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 046B21A) for COVID-19 vaccination.     No Medical History information was reported.    On 13-Apr-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 15-Apr-2021, the patient experienced EXFOLIATIVE RASH (A scaly, red, peeling rash started to develop initially on her chest, spreading to her arm, upper back, legs on the interior side, spreading up her neck and face, spreading all the way to her mouth), RASH (rash on face), RASH (rash over arms) and RASH (rash on leg). On 21-Jun-2021, the patient experienced ORAL MUCOSAL ERUPTION (rash spreading all the way to her mouth). At the time of the report, EXFOLIATIVE RASH (A scaly, red, peeling rash started to develop initially on her chest, spreading to her arm, upper back, legs on the interior side, spreading up her neck and face, spreading all the way to her mouth), ORAL MUCOSAL ERUPTION (rash spreading all the way to her mouth), RASH (rash on face), RASH (rash over arms) and RASH (rash on leg) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 15-Apr-2021, Blood pressure measurement: high mmHg (High) significantly elevated blood pressure.. On 15-Apr-2021, Body temperature: 102 (High) reported fever of 102 degrees F.     For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No Treatment medication was provided.  No concomitant treatment was provided.  Action taken with mRNA-1273 Moderna Vaccine was  Not applicable.  Other symptoms includes rash started spreading to her upper back   This case was linked to US-CBER-1229655, MOD-2021-230001 (Patient Link).
Sex: U
Vaccine: COVID19
Symptoms: Vaccination complication
Clinical narrative: Report a side effecT; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION COMPLICATION (Report a side effecT) in a patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced VACCINATION COMPLICATION (Report a side effecT). At the time of the report, VACCINATION COMPLICATION (Report a side effecT) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       Concomitant medication was not provided.  Treatment information was not provided.
Sex: U
Vaccine: COVID19
Symptoms: Vaccination site swelling
Clinical narrative: vaccination site swelling; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE SWELLING (vaccination site swelling) 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 19-Jun-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 20-Jun-2021, the patient experienced VACCINATION SITE SWELLING (vaccination site swelling). At the time of the report, VACCINATION SITE SWELLING (vaccination site swelling) outcome was unknown.            No concomitant medications was reported by the reporter. No treatment medications was  provided by the reporter.   Reporter did not allow further contact
Age: 51.0
Sex: M
Vaccine: COVID19
Symptoms: Illness, Nausea
Clinical narrative: nauseous; sick; This spontaneous case was reported by a consumer and describes the occurrence of NAUSEA (nauseous) and ILLNESS (sick) in a 51-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 040A21A) for COVID-19 vaccination.     Concomitant products included HYDROCODONE BITARTRATE, PARACETAMOL (NORCO), MORPHINE, PROCATEROL, DIPHENHYDRAMINE HYDROCHLORIDE (BENADRYL A), METRONIDAZOLE (DIAZOLE [METRONIDAZOLE]) and OMEPRAZOLE (PROPIZOLE) for an unknown indication.   On 17-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 14-Apr-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 NAUSEA (nauseous) and ILLNESS (sick). At the time of the report, NAUSEA (nauseous) and ILLNESS (sick) outcome was unknown.            Concomitant medications : Flexural Multi Vitamins No treatment medications was provided by the reporter   This case was linked to MOD-2021-230033 (Patient Link).
Age: 65.0
Sex: F
Vaccine: COVID19
Symptoms: Incorrect route of product administration, Vaccination site erythema
Clinical narrative: injection was done in a higher area and it hit the tendon; 3 inch red circle on the muscle where the injection was administered; This spontaneous case was reported by a consumer and describes the occurrence of INCORRECT ROUTE OF PRODUCT ADMINISTRATION (injection was done in a higher area and it hit the tendon) and VACCINATION SITE ERYTHEMA (3 inch red circle on the muscle where the injection was administered) in a 65-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 032M20A and 030M20A) for COVID-19 vaccination.     No Medical History information was reported.   On 19-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 19-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 INCORRECT ROUTE OF PRODUCT ADMINISTRATION (injection was done in a higher area and it hit the tendon) and VACCINATION SITE ERYTHEMA (3 inch red circle on the muscle where the injection was administered). At the time of the report, INCORRECT ROUTE OF PRODUCT ADMINISTRATION (injection was done in a higher area and it hit the tendon) and VACCINATION SITE ERYTHEMA (3 inch red circle on the muscle where the injection was administered) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant and treatment medications were reported.
Sex: U
Vaccine: COVID19
Symptoms: Body temperature increased, Pain of skin
Clinical narrative: skin began to feel sore; my temperature is slightly elevated; This spontaneous case was reported by a consumer and describes the occurrence of PAIN OF SKIN (skin began to feel sore) and BODY TEMPERATURE INCREASED (my temperature is slightly elevated) 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 21-Jun-2021 at 9:00 AM, 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 21-Jun-2021, the patient experienced BODY TEMPERATURE INCREASED (my temperature is slightly elevated). On 21-Jun-2021 at 4:00 PM, the patient experienced PAIN OF SKIN (skin began to feel sore). At the time of the report, PAIN OF SKIN (skin began to feel sore) and BODY TEMPERATURE INCREASED (my temperature is slightly elevated) outcome was unknown.            No concomitant medications were provided.  No treatment was reported for the events.
Age: 66.0
Sex: F
Vaccine: COVID19
Symptoms: Burning sensation, Fibromyalgia, Joint swelling, Pain in extremity, Peripheral swelling
Clinical narrative: football sized black and blue right arm; Pain shot up arm to neck; fibromyalgia; enlarged knuckles; burning legs / burning feet; This spontaneous case was reported by a consumer (subsequently medically confirmed) and describes the occurrence of FIBROMYALGIA (fibromyalgia), JOINT SWELLING (enlarged knuckles), BURNING SENSATION (burning legs / burning feet), PERIPHERAL SWELLING (football sized black and blue right arm) and PAIN IN EXTREMITY (Pain shot up arm to neck) in a 67-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 042B21A and 045A21A) for COVID-19 vaccination.     The patient's past medical history included Gastric bypass. Concurrent medical conditions included Spinal stenosis.   On 23-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 20-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 01-May-2021, the patient experienced FIBROMYALGIA (fibromyalgia), JOINT SWELLING (enlarged knuckles) and BURNING SENSATION (burning legs / burning feet). On an unknown date, the patient experienced PERIPHERAL SWELLING (football sized black and blue right arm) and PAIN IN EXTREMITY (Pain shot up arm to neck). At the time of the report, FIBROMYALGIA (fibromyalgia), JOINT SWELLING (enlarged knuckles) and BURNING SENSATION (burning legs / burning feet) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   The patient consulted two HCP and was prescribed steroids for treatment and was also recommended TYLENOL 2 STIXS, three times per day.  No concomitant medication was provided by the reporter.   This case was linked to MOD-2021-259143 (Patient Link).   Most recent FOLLOW-UP information incorporated above includes: On 16-Jul-2021: Follow up received on 16-JUL-2021 , Containing No Significant Information
Sex: U
Vaccine: COVID19
Symptoms: Expired product administered
Clinical narrative: administered 2 day after the expiry date; 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 (administered 2 day after the expiry date) in a patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 036C21A) for COVID-19 vaccination.     No Medical History information was reported.    On 21-Jun-2021, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 21-Jun-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (administered 2 day after the expiry date). At the time of the report, EXPIRED PRODUCT ADMINISTERED (administered 2 day after the expiry date) 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.   Treatment medications were not provided Concomitant medications were not mentioned   Most recent FOLLOW-UP information incorporated above includes: On 21-Jun-2021: Follow up information received on 23 JUN 2021 contains no significant information
Age: 51.0
Sex: M
Vaccine: COVID19
Symptoms: Ageusia, Anosmia, Illness, Nausea, SARS-CoV-2 test
Clinical narrative: sick; everything tasted like raw sewage and nothing tastes like it is supposed to; everything smelled like raw sewage and nothing smells like it is supposed to; body oil smells like raw sewage; nauseous; This spontaneous case was reported by a consumer and describes the occurrence of ILLNESS (sick), AGEUSIA (everything tasted like raw sewage and nothing tastes like it is supposed to), ANOSMIA (everything smelled like raw sewage and nothing smells like it is supposed to), SKIN ODOUR ABNORMAL (body oil smells like raw sewage) and NAUSEA (nauseous) in a 51-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 041B21A) for COVID-19 vaccination.     Concomitant products included HYDROCODONE BITARTRATE, PARACETAMOL (NORCO), MORPHINE, METAXALONE (FLEXURA), PROCATEROL, DIPHENHYDRAMINE HYDROCHLORIDE (BENADRYL [DIPHENHYDRAMINE HYDROCHLORIDE]), MULTIVITAMINS [VITAMINS NOS], DILOXANIDE FUROATE, METRONIDAZOLE (DIAZOLE [DILOXANIDE FUROATE;METRONIDAZOLE]) and OMEPRAZOLE (PROPIZOLE) for an unknown indication.   On 17-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 14-Apr-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 ILLNESS (sick), AGEUSIA (everything tasted like raw sewage and nothing tastes like it is supposed to), ANOSMIA (everything smelled like raw sewage and nothing smells like it is supposed to), SKIN ODOUR ABNORMAL (body oil smells like raw sewage) and NAUSEA (nauseous). At the time of the report, ILLNESS (sick), AGEUSIA (everything tasted like raw sewage and nothing tastes like it is supposed to), ANOSMIA (everything smelled like raw sewage and nothing smells like it is supposed to), SKIN ODOUR ABNORMAL (body oil smells like raw sewage) and NAUSEA (nauseous) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): In December 2020, SARS-CoV-2 test: unknown (Positive) Positive.         No treatment medications were provided by the reporter.   This case was linked to MOD-2021-230022 (Patient Link).