chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 76.0
Sex: F
Vaccine: COVID19
Symptoms: Asthenia, Myalgia, Nausea, Rhinorrhoea, Vaccination site pain
Clinical narrative: weakness; muscle aches/arm soreness; nausea; nose running; pain in the arm where I got the shot; This spontaneous case was reported by a consumer and describes the occurrence of ASTHENIA (weakness), MYALGIA (muscle aches/arm soreness), NAUSEA (nausea), RHINORRHOEA (nose running) and VACCINATION SITE PAIN (pain in the arm where I got the shot) in a 76-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 037F21A, 006M20A and 042120A) for COVID-19 vaccination.     Concomitant products included VALSARTAN for Blood pressure, CLONIDINE for Digestion impaired, DILTIAZEM for Gut pain, OMEPRAZOLE (PROTONIX [OMEPRAZOLE]) for Reflux esophagitis, ERGOCALCIFEROL, RETINOL PALMITATE (VITAMINS A & D), POTASSIUM CHLORIDE, COLECALCIFEROL (D3) and CALCIUM CITRATE, COLECALCIFEROL (CITRACAL + D [CALCIUM CITRATE;COLECALCIFEROL]) for an unknown indication.   On 18-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 23-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 04-Sep-2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient experienced ASTHENIA (weakness), MYALGIA (muscle aches/arm soreness), NAUSEA (nausea), RHINORRHOEA (nose running) and VACCINATION SITE PAIN (pain in the arm where I got the shot). The patient was treated with PARACETAMOL (TYLENOL) for Adverse event, at an unspecified dose and frequency. At the time of the report, ASTHENIA (weakness), MYALGIA (muscle aches/arm soreness), NAUSEA (nausea), RHINORRHOEA (nose running) and VACCINATION SITE PAIN (pain in the arm where I got the shot) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   This case was linked to MOD-2021-311614 (Patient Link).
Age: 45.0
Sex: M
Vaccine: COVID19
Symptoms: Expired product administered
Clinical narrative: This spontaneous case was reported by an other health care professional and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Received expired vaccine) in a 45-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 039A21A.) for COVID-19 vaccination. No Medical History information was reported. On 07-Sep-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 07-Sep-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (Received expired vaccine). On 07-Sep-2021, EXPIRED PRODUCT ADMINISTERED (Received expired vaccine) had resolved. For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments. No Concomitant medication was reported. No treatment medications were reported This case was linked to MOD-2021-310991 (Patient Link).
Sex: F
Vaccine: COVID19
Symptoms: Vaccination complication
Clinical narrative: Two side effects; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION COMPLICATION (Two side effects) 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 VACCINATION COMPLICATION (Two side effects). At the time of the report, VACCINATION COMPLICATION (Two side effects) outcome was unknown.            No relevant concomitant medications were reported. No treatment information was provided.   This case was linked to MOD-2021-310988 (Patient Link).
Age: 35.0
Sex: F
Vaccine: COVID19
Symptoms: Product dose omission issue
Clinical narrative: Did not receive 2nd dose of vaccine; This spontaneous case was reported by a consumer and describes the occurrence of PRODUCT DOSE OMISSION ISSUE (Did not receive 2nd dose of vaccine) 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 14-Jan-2021, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced PRODUCT DOSE OMISSION ISSUE (Did not receive 2nd dose of vaccine). At the time of the report, PRODUCT DOSE OMISSION ISSUE (Did not receive 2nd dose of vaccine) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No concomitant product was provided by the reporter. No treatment medication was provided.
Sex: M
Vaccine: COVID19
Symptoms: Myalgia
Clinical narrative: just some aches; This spontaneous case was reported by a consumer and describes the occurrence of MYALGIA (just some aches) in a male patient of an unknown age 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 first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced MYALGIA (just some aches). At the time of the report, MYALGIA (just some aches) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No concomitant medications were provided by reporter. No treatment medications were provided by reporter.   This case was linked to MOD-2021-311195 (Patient Link).
Age: 49.0
Sex: M
Vaccine: COVID19
Symptoms: Fatigue, Myalgia
Clinical narrative: sore arm; felt tired; This spontaneous case was reported by a consumer and describes the occurrence of MYALGIA (sore arm) and FATIGUE (felt tired) in a 49-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 002F21A) for COVID-19 vaccination.     No Medical History information was reported.    On 15-Aug-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 16-Aug-2021, the patient experienced MYALGIA (sore arm) and FATIGUE (felt tired). On 18-Aug-2021, FATIGUE (felt tired) had resolved. On 19-Aug-2021, MYALGIA (sore arm) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No concomitant medications were provided by reporter. No treatment details were provided by reporter.
Sex: U
Vaccine: COVID19
Symptoms: Mass
Clinical narrative: a big lump on collarbone; This spontaneous case was reported by a consumer and describes the occurrence of MASS (a big lump on collarbone) 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 MASS (a big lump on collarbone). At the time of the report, MASS (a big lump on collarbone) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No concomitant medications reported. No treatment information reported.   Reporter did not allow further contact
Sex: U
Vaccine: COVID19
Symptoms: Anosmia, Nasal congestion
Clinical narrative: loss of smell; my nose is also stuffy; This spontaneous case was reported by a consumer and describes the occurrence of ANOSMIA (loss of smell) and NASAL CONGESTION (my nose is also stuffy) 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 ANOSMIA (loss of smell) and NASAL CONGESTION (my nose is also stuffy). At the time of the report, ANOSMIA (loss of smell) and NASAL CONGESTION (my nose is also stuffy) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No concomitant medications were reported by the reporter Treatment information was not reported.    Reporter did not allow further contact
Sex: U
Vaccine: COVID19
Symptoms: Palpitations
Clinical narrative: Are heart palpitations a side effect after the second dose of the 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 PALPITATIONS (Are heart palpitations a side effect after the second dose of the vaccine) in a patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On an unknown date, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced PALPITATIONS (Are heart palpitations a side effect after the second dose of the vaccine). At the time of the report, PALPITATIONS (Are heart palpitations a side effect after the second dose of the vaccine) outcome was unknown.            No concomitant medication were provided.  No treatment medication were provided.
Sex: F
Vaccine: COVID19
Symptoms: Product dose omission issue, Pyrexia
Clinical narrative: running a slight fever; received her 1st dose of the Moderna Covid-19 Vaccine on 24Apr2021, but never got the 2nd dose; This spontaneous case was reported by a consumer and describes the occurrence of PYREXIA (running a slight fever) and PRODUCT DOSE OMISSION ISSUE (received her 1st dose of the Moderna Covid-19 Vaccine on 24Apr2021, but never got the 2nd dose) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. Unknown) 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 PYREXIA (running a slight fever) and PRODUCT DOSE OMISSION ISSUE (received her 1st dose of the Moderna Covid-19 Vaccine on 24Apr2021, but never got the 2nd dose). At the time of the report, PYREXIA (running a slight fever) and PRODUCT DOSE OMISSION ISSUE (received her 1st dose of the Moderna Covid-19 Vaccine on 24Apr2021, but never got the 2nd dose) outcome was unknown.            Concomitant medication was not provided. Treatment information was not provided.
Age: 68.0
Sex: M
Vaccine: COVID19
Symptoms: Heart rate, Malaise
Clinical narrative: Did not feel very well for a couple of days; This spontaneous case was reported by a consumer and describes the occurrence of MALAISE (Did not feel very well for a couple of days) in a 68-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 029A21A and 0062G21A) for COVID-19 vaccination.     No Medical History information was reported.   On 02-Mar-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 01-Sep-2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 02-Mar-2021, the patient experienced MALAISE (Did not feel very well for a couple of days). At the time of the report, MALAISE (Did not feel very well for a couple of days) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 02-Mar-2021, Heart rate: high (High) elevated Heart rate for two days..         No concomitant medication were reported. No treatment information was provided by the reporter.   This case was linked to MOD-2021-311007, MOD-2021-311053 (Patient Link).
Sex: F
Vaccine: COVID19
Symptoms: Adverse event
Clinical narrative: serious adverse event/ within 12 hours of receipt of the vaccine; This spontaneous case was reported by a physician and describes the occurrence of ADVERSE EVENT (serious adverse event/ within 12 hours of receipt of the vaccine) 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 third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced ADVERSE EVENT (serious adverse event/ within 12 hours of receipt of the vaccine) (seriousness criterion hospitalization). At the time of the report, ADVERSE EVENT (serious adverse event/ within 12 hours of receipt of the vaccine) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   Concomitant drug was not reported. Treatment medication was not reported.  It was reported that patient has been hospitalized due to adverse event.  Based on the current available information and temporal association between the use of the product and the start date of the event, a causal relationship cannot be excluded.; Sender's Comments: Based on the current available information and temporal association between the use of the product and the start date of the event, a causal relationship cannot be excluded.
Age: 72.0
Sex: F
Vaccine: COVID19
Symptoms: Fatigue, Muscle spasms, Myalgia, Nausea, Peripheral swelling
Clinical narrative: Right hand swelled up, looked like a mitten; Fatigue; Nausea; Sore arm,achy all over,serious body aches; Cramping,muscle cramps in both hands; This spontaneous case was reported by a consumer and describes the occurrence of MUSCLE SPASMS (Cramping,muscle cramps in both hands), PERIPHERAL SWELLING (Right hand swelled up, looked like a mitten), MYALGIA (Sore arm,achy all over,serious body aches), FATIGUE (Fatigue) and NAUSEA (Nausea) in a 72-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 036C21A, 025A21A and 030B21A) for COVID-19 vaccination.     Concurrent medical conditions included Sjogren's, Rheumatoid arthritis and Fibromyalgia. Concomitant products included CODEINE, TRAZODONE, ONDANSETRON HYDROCHLORIDE (ZOFRAN [ONDANSETRON HYDROCHLORIDE]), WARFARIN, CEVIMELINE HYDROCHLORIDE (EVOXAC), ALBUTEROL SULFATE, METOPROLOL, LIDOCAINE, FLUTICASONE PROPIONATE (FLONASE [FLUTICASONE PROPIONATE]), PREDNISONE, TORASEMIDE (TORSEMIDE), GABAPENTIN, LATANOPROST, ATORVASTATIN CALCIUM (LIPITOR), PANTOPRAZOLE, PROBIOTICS NOS, ERGOCALCIFEROL (VITAMIN D2), CALCIUM and ZOLMITRIPTAN (ZOMIG) for an unknown indication.   On 25-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 31-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 02-Sep-2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 04-Sep-2021, the patient experienced MUSCLE SPASMS (Cramping,muscle cramps in both hands) and MYALGIA (Sore arm,achy all over,serious body aches). On an unknown date, the patient experienced PERIPHERAL SWELLING (Right hand swelled up, looked like a mitten), FATIGUE (Fatigue) and NAUSEA (Nausea). At the time of the report, MUSCLE SPASMS (Cramping,muscle cramps in both hands), MYALGIA (Sore arm,achy all over,serious body aches), FATIGUE (Fatigue) and NAUSEA (Nausea) had not resolved and PERIPHERAL SWELLING (Right hand swelled up, looked like a mitten) was resolving.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No treatment medication was reported by patient.  Patient reported that she was still experiencing symptoms, but hand was not as swollen.
Age: 67.0
Sex: F
Vaccine: COVID19
Symptoms: Myalgia
Clinical narrative: sore left injection site arm; This spontaneous case was reported by a consumer and describes the occurrence of MYALGIA (sore left injection site arm) in a 67-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 010M20A) for COVID-19 vaccination.     No Medical History information was reported.    On 02-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 02-Feb-2021,  after starting mRNA-1273 (Moderna COVID-19 Vaccine), the patient experienced MYALGIA (sore left injection site arm). At the time of the report, MYALGIA (sore left injection site arm) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Concomitant product use was not provided.  Treatment product information was not provided.   This case was linked to MOD-2021-311211, MOD-2021-311210 (Patient Link).
Age: 64.0
Sex: M
Vaccine: COVID19
Symptoms: Myalgia
Clinical narrative: muscle pain in my left leg. It like runs up and down, it'll stop to my knee, and then get to my lower leg; This spontaneous case was reported by a consumer and describes the occurrence of MYALGIA (muscle pain in my left leg. It like runs up and down, it'll stop to my knee, and then get to my lower leg) in a 64-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On 19-Aug-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 22-Aug-2021, the patient experienced MYALGIA (muscle pain in my left leg. It like runs up and down, it'll stop to my knee, and then get to my lower leg). On 07-Sep-2021, MYALGIA (muscle pain in my left leg. It like runs up and down, it'll stop to my knee, and then get to my lower leg) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Concomitant medication was not provided Treatment information was not reported  Patient's second dose is due on 16-Sep-2021.
Sex: U
Vaccine: COVID19
Symptoms: Dizziness, Headache, Herpes zoster
Clinical narrative: shingles on my eardrum; dizziness; head hurting; This spontaneous case was reported by an other health care professional and describes the occurrence of HERPES ZOSTER (shingles on my eardrum), DIZZINESS (dizziness) and HEADACHE (head hurting) 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 May 2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced HERPES ZOSTER (shingles on my eardrum), DIZZINESS (dizziness) and HEADACHE (head hurting). At the time of the report, HERPES ZOSTER (shingles on my eardrum), DIZZINESS (dizziness) and HEADACHE (head hurting) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant drug details were reported. No treatment details were reported.
Age: 87.0
Sex: F
Vaccine: COVID19
Symptoms: Fatigue, Hypersomnia, Urinary incontinence, Vaccination site reaction
Clinical narrative: large Covid arm 3 inches across and 4 inches deep got Covid arm again; very tired; slept for 36 hours straight; loss control of bladder; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE REACTION (large Covid arm 3 inches across and 4 inches deep got Covid arm again), FATIGUE (very tired), HYPERSOMNIA (slept for 36 hours straight) and URINARY INCONTINENCE (loss control of bladder) in an 87-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 012M20A) for COVID-19 vaccination.     No medical history was reported by reporter.  Concomitant products included OMEPRAZOLE, LEVOTHYROXINE, PHENYTOIN SODIUM (DILANTIN D.A.), SPIRONOLACTONE, HYDROCHLOROTHIAZIDE, CALCIUM, COLECALCIFEROL (CALCIUM WITH D3), SIMVASTATIN, WARFARIN and METOPROLOL for an unknown indication.    On 17-Feb-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced VACCINATION SITE REACTION (large Covid arm 3 inches across and 4 inches deep got Covid arm again), FATIGUE (very tired), HYPERSOMNIA (slept for 36 hours straight) and URINARY INCONTINENCE (loss control of bladder). The patient was treated with PARACETAMOL (TYLENOL) at a dose of 1 dosage form. At the time of the report, VACCINATION SITE REACTION (large Covid arm 3 inches across and 4 inches deep got Covid arm again), FATIGUE (very tired), HYPERSOMNIA (slept for 36 hours straight) and URINARY INCONTINENCE (loss control of bladder) outcome was unknown.            This case was linked to MOD-2021-311021 (Patient Link).
Sex: U
Vaccine: COVID19
Symptoms: Abdominal pain, Dizziness, Faeces soft, Headache
Clinical narrative: Dizziness; Stomach cramping; Soft stools; Headache; This spontaneous case was reported by a consumer and describes the occurrence of DIZZINESS (Dizziness), ABDOMINAL PAIN (Stomach cramping), FAECES SOFT (Soft stools) and HEADACHE (Headache) 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 DIZZINESS (Dizziness), ABDOMINAL PAIN (Stomach cramping), FAECES SOFT (Soft stools) and HEADACHE (Headache). At the time of the report, DIZZINESS (Dizziness), ABDOMINAL PAIN (Stomach cramping), FAECES SOFT (Soft stools) and HEADACHE (Headache) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No concomitant product use was provided by the reporter.   No treatment medications were reported.
Age: 46.0
Sex: F
Vaccine: COVID19
Symptoms: Asthenia, Body temperature, Feeling abnormal, Hallucination, Pyrexia
Clinical narrative: Still dont feel normal; Fever creeping up to 102.7; Fever; Hallucinations; Very weak; Dont feel like myself; This spontaneous case was reported by a consumer and describes the occurrence of HALLUCINATION (Hallucinations) in a 47-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 939906, 032L20A and 037K20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.   On 06-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 04-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 05-Sep-2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 05-Sep-2021, the patient experienced HALLUCINATION (Hallucinations) (seriousness criterion medically significant) and ASTHENIA (Very weak). 05-Sep-2021, the patient experienced FEELING ABNORMAL (Dont feel like myself). On 05-Sep-2021 at 5:00 PM, the patient experienced PYREXIA (Fever). On 07-Sep-2021, the patient experienced FEELING ABNORMAL (Still dont feel normal) and PYREXIA (Fever creeping up to 102.7). On 07-Sep-2021, HALLUCINATION (Hallucinations) had resolved. At the time of the report, ASTHENIA (Very weak), FEELING ABNORMAL (Dont feel like myself), FEELING ABNORMAL (Still dont feel normal), PYREXIA (Fever) and PYREXIA (Fever creeping up to 102.7) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 07-Sep-2021, Body temperature: 102.7 (High) 102.7 F.         Concomitant medications were not reported .  Reported that patient got the booster of Moderna. she experienced hallucinations from it, The patient states she started with a fever on Sunday 05-Sep-2021 about 5 PM, The hallucinations started between 10-12 PM, She was very weak, and she still doesn't feel normal on 07Sep2021.  Company comment: Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded.  More information has been requested.; Sender's Comments: Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded.  More information has been requested.
Sex: U
Vaccine: COVID19
Symptoms: Rash, Urticaria
Clinical narrative: Is rash and hives abreported side effect to the booster shot; Is rash and hives abreported side effect to the booster shot; This spontaneous case was reported by a consumer and describes the occurrence of RASH (Is rash and hives abreported side effect to the booster shot) and URTICARIA (Is rash and hives abreported side effect to the booster shot) 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 (Is rash and hives abreported side effect to the booster shot) and URTICARIA (Is rash and hives abreported side effect to the booster shot). At the time of the report, RASH (Is rash and hives abreported side effect to the booster shot) and URTICARIA (Is rash and hives abreported side effect to the booster shot) 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.
Sex: F
Vaccine: COVID19
Symptoms: COVID-19
Clinical narrative: COVID; This spontaneous case was reported by a consumer and describes the occurrence of COVID-19 (COVID) 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 second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On an unknown date, the patient experienced COVID-19 (COVID) (seriousness criterion hospitalization). At the time of the report, COVID-19 (COVID) outcome was unknown.            Relevant concomitant product usage were not reported by the reporter. No treatment details were added.  Reported that currently in the hospital with COVID. patient received both doses of Moderna probably two months ago, patient was asking her condition was COVID or a variant.  Company Comment : Based on the current available information, the mRNA-1273 does not contain a virus capable of causing COVID-19 infection after vaccination. Therefore causality for COVID 19 is assessed as not applicable.; Sender's Comments: Based on the current available information, the mRNA-1273 does not contain a virus capable of causing COVID-19 infection after vaccination. Therefore causality for COVID 19 is assessed as not applicable. .
Age: 82.0
Sex: F
Vaccine: COVID19
Symptoms: Asthenia, Fatigue, Feeling abnormal, Mobility decreased
Clinical narrative: I was a totally different person; Could not move; Weak; Very tired; This spontaneous case was reported by a consumer and describes the occurrence of FEELING ABNORMAL (I was a totally different person), MOBILITY DECREASED (Could not move), ASTHENIA (Weak) and FATIGUE (Very tired) in an 82-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     Concurrent medical conditions included Type 1 diabetes mellitus.    On 01-Sep-2021, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 06-Sep-2021, the patient experienced FEELING ABNORMAL (I was a totally different person), MOBILITY DECREASED (Could not move), ASTHENIA (Weak) and FATIGUE (Very tired). At the time of the report, FEELING ABNORMAL (I was a totally different person), MOBILITY DECREASED (Could not move), ASTHENIA (Weak) and FATIGUE (Very tired) outcome was unknown.            Concomitant medication of the patient was not reported.  The patient did not took any medications or treatment.   Most recent FOLLOW-UP information incorporated above includes: On 07-Sep-2021: Follow-up information received on 07-Sep-2021; included no new information.
Age: 64.0
Sex: F
Vaccine: COVID19
Symptoms: Ear discomfort, Ear pain, Magnetic resonance imaging head, Tinnitus
Clinical narrative: Ringing in right ear/ringing had been going on for 5 months/tinnitus; Pain in her right ear; No ringing but had fullness in left ear; Left ear started hurting a few days; This spontaneous case was reported by a consumer and describes the occurrence of TINNITUS (Ringing in right ear/ringing had been going on for 5 months/tinnitus), EAR PAIN (Pain in her right ear), EAR DISCOMFORT (No ringing but had fullness in left ear) and EAR PAIN (Left ear started hurting a few days) in a 64-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 046B21A and 032M20A) for COVID-19 vaccination.     The medical history information was not provided by the reporter.  Concomitant products included LEVOTHYROXINE SODIUM (SYNTHROID) for an unknown indication.   On 09-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 12-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 14-Apr-2021, the patient experienced TINNITUS (Ringing in right ear/ringing had been going on for 5 months/tinnitus) and EAR PAIN (Pain in her right ear). In 2021, the patient experienced EAR DISCOMFORT (No ringing but had fullness in left ear) and EAR PAIN (Left ear started hurting a few days). The patient was treated with PREDNISONE in 2021 for Adverse event, at an unspecified dose and frequency; PREDNISONE in 2021 for Adverse event, at an unspecified dose and frequency and IBUPROFEN (ADVIL [IBUPROFEN]) in 2021 for Ear pain, at a dose of UNK, prn. At the time of the report, TINNITUS (Ringing in right ear/ringing had been going on for 5 months/tinnitus), EAR PAIN (Pain in her right ear), EAR DISCOMFORT (No ringing but had fullness in left ear) and EAR PAIN (Left ear started hurting a few days) had not resolved.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): In 2021, Magnetic resonance imaging head: normal (normal) Brain MRI done a few weeks ago was normal.         Patient's ENT had put her on Prednisone twice. She was looking for another ENT for second opinion.   Patient was fine after her first dose.
Age: 68.0
Sex: F
Vaccine: COVID19
Symptoms: Chest pain, Chills, Diarrhoea, Fatigue, Feeling abnormal
Clinical narrative: This spontaneous case was reported by a consumer and describes the occurrence of DIARRHOEA (diarrhea,), CHEST PAIN (chest pain), FEELING ABNORMAL (feeling like she has been hit by a truck.), PAIN (Body ache) and CHILLS (chills) in a 68-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 04-Sep-2021, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced DIARRHOEA (diarrhea,), CHEST PAIN (chest pain), FEELING ABNORMAL (feeling like she has been hit by a truck.), PAIN (Body ache), CHILLS (chills), HEADACHE (headache), VOMITING (throwing up), MYALGIA (sore arm) and FATIGUE (fatigue). At the time of the report, DIARRHOEA (diarrhea,), CHEST PAIN (chest pain), FEELING ABNORMAL (feeling like she has been hit by a truck.), PAIN (Body ache), CHILLS (chills), HEADACHE (headache), VOMITING (throwing up), MYALGIA (sore arm) and FATIGUE (fatigue) outcome was unknown. patient stated that she received her third dose of Moderna Covid-19 Vaccine  on 04Sep2021, and she  did not provide any detailed  information about her vaccination of her 1 st,  2 nd  and 3 rd dose ( lot number Not provided   & expiration date : Not provided, unknown arm ) No Medical History Reported. No Concomitant medication Reported. Reporter did not allow further contact
Age: 68.0
Sex: F
Vaccine: COVID19
Symptoms: Headache, Myalgia, Pain, Vomiting
Clinical narrative: This spontaneous case was reported by a consumer and describes the occurrence of DIARRHOEA (diarrhea,), CHEST PAIN (chest pain), FEELING ABNORMAL (feeling like she has been hit by a truck.), PAIN (Body ache) and CHILLS (chills) in a 68-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 04-Sep-2021, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced DIARRHOEA (diarrhea,), CHEST PAIN (chest pain), FEELING ABNORMAL (feeling like she has been hit by a truck.), PAIN (Body ache), CHILLS (chills), HEADACHE (headache), VOMITING (throwing up), MYALGIA (sore arm) and FATIGUE (fatigue). At the time of the report, DIARRHOEA (diarrhea,), CHEST PAIN (chest pain), FEELING ABNORMAL (feeling like she has been hit by a truck.), PAIN (Body ache), CHILLS (chills), HEADACHE (headache), VOMITING (throwing up), MYALGIA (sore arm) and FATIGUE (fatigue) outcome was unknown. patient stated that she received her third dose of Moderna Covid-19 Vaccine  on 04Sep2021, and she  did not provide any detailed  information about her vaccination of her 1 st,  2 nd  and 3 rd dose ( lot number Not provided   & expiration date : Not provided, unknown arm ) No Medical History Reported. No Concomitant medication Reported. Reporter did not allow further contact
Age: 44.0
Sex: F
Vaccine: COVID19
Symptoms: Arthralgia, Fatigue, Headache, Myalgia, SARS-CoV-2 test
Clinical narrative: This spontaneous case was reported by a consumer and describes the occurrence of MYALGIA (Ache and pain all over her body, muscle pain), ARTHRALGIA (Joint pain), HEADACHE (Headache), FATIGUE (A few days later she felt tired all the time, A few days later she felt tired all the time) and SARS-COV-2 TEST POSITIVE (She took two at home COVID test, which came out positive both times) in a 44-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 052E21A) for COVID-19 vaccination. No Medical History was provided by the reporter.  Concomitant products included ESCITALOPRAM OXALATE (LEXAPRO) and COLECALCIFEROL (VITAMIN D3) for an unknown indication.On 23-Aug-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 23-Aug-2021, the patient experienced MYALGIA (Ache and pain all over her body, muscle pain). On 24-Aug-2021, the patient experienced ARTHRALGIA (Joint pain) and HEADACHE (Headache). On an unknown date, the patient experienced FATIGUE (A few days later she felt tired all the time, A few days later she felt tired all the time) and SARS-COV-2 TEST POSITIVE (She took two at home COVID test, which came out positive both times). The patient was treated with IBUPROFEN for Myalgia, at a dose of Unknown. At the time of the report, MYALGIA (Ache and pain all over her body, muscle pain), ARTHRALGIA (Joint pain), HEADACHE (Headache), FATIGUE (A few days later she felt tired all the time, A few days later she felt tired all the time) and SARS-COV-2 TEST POSITIVE (She took two at home COVID test, which came out positive both times) outcome was unknown.    DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 06-Sep-2021, SARS-CoV-2 test: positive (Positive) Positive. On 07-Sep-2021, SARS-CoV-2 test: positive (Positive) Positive. The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.
Age: 44.0
Sex: F
Vaccine: COVID19
Symptoms: SARS-CoV-2 test positive
Clinical narrative: This spontaneous case was reported by a consumer and describes the occurrence of MYALGIA (Ache and pain all over her body, muscle pain), ARTHRALGIA (Joint pain), HEADACHE (Headache), FATIGUE (A few days later she felt tired all the time, A few days later she felt tired all the time) and SARS-COV-2 TEST POSITIVE (She took two at home COVID test, which came out positive both times) in a 44-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 052E21A) for COVID-19 vaccination. No Medical History was provided by the reporter.  Concomitant products included ESCITALOPRAM OXALATE (LEXAPRO) and COLECALCIFEROL (VITAMIN D3) for an unknown indication.On 23-Aug-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 23-Aug-2021, the patient experienced MYALGIA (Ache and pain all over her body, muscle pain). On 24-Aug-2021, the patient experienced ARTHRALGIA (Joint pain) and HEADACHE (Headache). On an unknown date, the patient experienced FATIGUE (A few days later she felt tired all the time, A few days later she felt tired all the time) and SARS-COV-2 TEST POSITIVE (She took two at home COVID test, which came out positive both times). The patient was treated with IBUPROFEN for Myalgia, at a dose of Unknown. At the time of the report, MYALGIA (Ache and pain all over her body, muscle pain), ARTHRALGIA (Joint pain), HEADACHE (Headache), FATIGUE (A few days later she felt tired all the time, A few days later she felt tired all the time) and SARS-COV-2 TEST POSITIVE (She took two at home COVID test, which came out positive both times) outcome was unknown.    DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 06-Sep-2021, SARS-CoV-2 test: positive (Positive) Positive. On 07-Sep-2021, SARS-CoV-2 test: positive (Positive) Positive. The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.
Sex: U
Vaccine: COVID19
Symptoms: Vaccination complication
Clinical narrative: side effect; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION COMPLICATION (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 VACCINATION COMPLICATION (side effect). At the time of the report, VACCINATION COMPLICATION (side effect) 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.
Sex: F
Vaccine: COVID19
Symptoms: Rash
Clinical narrative: Rash on my stomach and my left thigh; This spontaneous case was reported by a consumer and describes the occurrence of RASH (Rash on my stomach and my left thigh) 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 RASH (Rash on my stomach and my left thigh). At the time of the report, RASH (Rash on my stomach and my left thigh) had not resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No concomitant product information was provided.  Treatment information was not provided.
Age: 52.0
Sex: M
Vaccine: COVID19
Symptoms: Back pain, Chest pain, Gait disturbance, Myalgia, Pain in extremity
Clinical narrative: Most excruciating pain in his life in his back right side.; Back right thigh was so painful, he couldn't step down on the leg/back right thigh now a very lite pain; back right thigh was so painful, he couldn't step down on the leg; tissue pain  pain across chest area that feels like his is sore from a work out that comes and goes/ It doesn't feel like heart pain; body pains have come and gone since the 2nd shot; This spontaneous case was reported by a consumer and describes the occurrence of BACK PAIN (Most excruciating pain in his life in his back right side.), PAIN IN EXTREMITY (Back right thigh was so painful, he couldn't step down on the leg/back right thigh now a very lite pain), GAIT DISTURBANCE (back right thigh was so painful, he couldn't step down on the leg), CHEST PAIN (tissue pain  pain across chest area that feels like his is sore from a work out that comes and goes/ It doesn't feel like heart pain) and MYALGIA (body pains have come and gone since the 2nd shot) in a 52-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 018B21A and 042B21A) for COVID-19 vaccination.     No Medical History information was reported.   On 09-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 07-May-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 08-May-2021, the patient experienced BACK PAIN (Most excruciating pain in his life in his back right side.), PAIN IN EXTREMITY (Back right thigh was so painful, he couldn't step down on the leg/back right thigh now a very lite pain), GAIT DISTURBANCE (back right thigh was so painful, he couldn't step down on the leg), CHEST PAIN (tissue pain  pain across chest area that feels like his is sore from a work out that comes and goes/ It doesn't feel like heart pain) and MYALGIA (body pains have come and gone since the 2nd shot). At the time of the report, BACK PAIN (Most excruciating pain in his life in his back right side.), PAIN IN EXTREMITY (Back right thigh was so painful, he couldn't step down on the leg/back right thigh now a very lite pain), GAIT DISTURBANCE (back right thigh was so painful, he couldn't step down on the leg) and CHEST PAIN (tissue pain  pain across chest area that feels like his is sore from a work out that comes and goes/ It doesn't feel like heart pain) outcome was unknown and MYALGIA (body pains have come and gone since the 2nd shot) had resolved.            No concomitant medications reported. After the second shot, the next day he had the most excruciating pain in his back right side. The next day, his back right thigh was so painful, he couldn't step down on the leg. Also he had tissue pain across chest area.  It was not like heart pain. All of the body pains have come and went since the 2nd shot.  No treatment information was provided.   This case was linked to MOD-2021-309998 (Patient Link).
Age: 80.0
Sex: F
Vaccine: COVID19
Symptoms: Loss of consciousness, Syncope
Clinical narrative: fainted apx. 15 hours after the second shot.; About 15 hours after receiving 2nd dose, she passed out and landed on her cheeks.; This spontaneous case was reported by a consumer and describes the occurrence of SYNCOPE (fainted apx. 15 hours after the second shot.) and LOSS OF CONSCIOUSNESS (About 15 hours after receiving 2nd dose, she passed out and landed on her cheeks.) in an 81-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. Unknown) for COVID-19 vaccination.     No Medical History information was reported.   On 20-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 21-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 22-Mar-2021, the patient experienced SYNCOPE (fainted apx. 15 hours after the second shot.) (seriousness criterion medically significant) and LOSS OF CONSCIOUSNESS (About 15 hours after receiving 2nd dose, she passed out and landed on her cheeks.) (seriousness criterion medically significant). At the time of the report, SYNCOPE (fainted apx. 15 hours after the second shot.) and LOSS OF CONSCIOUSNESS (About 15 hours after receiving 2nd dose, she passed out and landed on her cheeks.) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   On an unknown date  EKG was done with unknown results. Concomitant: Blood pressure medicine.  Company comment: Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded.   Most recent FOLLOW-UP information incorporated above includes: On 08-Sep-2021: Upon follow-up receipt: Reporter information added, event added, dose 1 information added, event start date added and inarrative updated.; Sender's Comments: Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded.
Age: 36.0
Sex: F
Vaccine: COVID19
Symptoms: Paraesthesia, Vaccination site pain
Clinical narrative: Tingling in 2 fingers of her left hand; She had 1-2 days of tenderness in her arm at the injection site; This spontaneous case was reported by a consumer and describes the occurrence of PARAESTHESIA (Tingling in 2 fingers of her left hand) and VACCINATION SITE PAIN (She had 1-2 days of tenderness in her arm at the injection site) in a 36-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 026D21A) for COVID-19 vaccination.     No Medical History information was reported.    On 08-Aug-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 08-Aug-2021, the patient experienced VACCINATION SITE PAIN (She had 1-2 days of tenderness in her arm at the injection site). On an unknown date, the patient experienced PARAESTHESIA (Tingling in 2 fingers of her left hand). The patient was treated with PARACETAMOL (TYLENOL) at a dose of 1 dosage form and IBUPROFEN (ADVIL [IBUPROFEN]) at a dose of 1 dosage form. On 10-Aug-2021, VACCINATION SITE PAIN (She had 1-2 days of tenderness in her arm at the injection site) had resolved. At the time of the report, PARAESTHESIA (Tingling in 2 fingers of her left hand) 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.   About 1 week patient had tingling in 2 fingers of her left hand.  Patient used ice for her shoulder and was prescribed a 5 day curse of steroids which she had not taken yet.  Concomitant medications was not provided by the reporter   This case was linked to MOD-2021-311159 (Patient Link).