chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Sex: U
Vaccine: COVID19
Symptoms: Chest pain, Extrasystoles, Eye disorder, Oral discomfort, Vaccination complication
Clinical narrative: i have a lot reactions/ mi frontal swallow some partas of mi bodie; i have sometimes big mouth; big eye; I have chest pain; i tink mi heart stoped for a second; 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 VACCINATION COMPLICATION (i have a lot reactions/ mi frontal swallow some partas of mi bodie), ORAL DISCOMFORT (i have sometimes big mouth), EYE DISORDER (big eye), CHEST PAIN (I have chest pain) and EXTRASYSTOLES (i tink mi heart stoped for a second) in a patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. Unknown) for COVID-19 vaccination.     No Medical History information was reported.    On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced VACCINATION COMPLICATION (i have a lot reactions/ mi frontal swallow some partas of mi bodie), ORAL DISCOMFORT (i have sometimes big mouth), EYE DISORDER (big eye), CHEST PAIN (I have chest pain) and EXTRASYSTOLES (i tink mi heart stoped for a second). At the time of the report, VACCINATION COMPLICATION (i have a lot reactions/ mi frontal swallow some partas of mi bodie), ORAL DISCOMFORT (i have sometimes big mouth), EYE DISORDER (big eye), CHEST PAIN (I have chest pain) and EXTRASYSTOLES (i tink mi heart stoped for a second) had not resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       Patient reported that he had appointment for second schedule on the day of reporting. No concomitant medications were reported. No treatment medications were reported.
Sex: F
Vaccine: COVID19
Symptoms: SARS-CoV-2 test, SARS-CoV-2 test positive
Clinical narrative: Tested positive for COVID; This spontaneous case was reported by a pharmacist and describes the occurrence of SARS-COV-2 TEST POSITIVE (Tested positive for 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 30-Jul-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 10-Aug-2021, the patient experienced SARS-COV-2 TEST POSITIVE (Tested positive for COVID). At the time of the report, SARS-COV-2 TEST POSITIVE (Tested positive for COVID) had resolved.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 10-Aug-2021, SARS-CoV-2 test: positive (Positive) Tested positive for COVID. On 24-Aug-2021, SARS-CoV-2 test: negative (Negative) She tested negative twice for COVID.     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.   Pharmacist wants to know whether patient tested positive for COVID-19 when second dose was given.  No concomitant medications reported.  No treatment information was reported by reporter.
Sex: F
Vaccine: COVID19
Symptoms: Antibody test, COVID-19, Eye discharge, Eye pruritus
Clinical narrative: Eyes has been itching since receiving the vaccine; she had been having ocular discharge which she has never had before; This spontaneous case was reported by a consumer and describes the occurrence of EYE PRURITUS (Eyes has been itching since receiving the vaccine) and EYE DISCHARGE (she had been having ocular discharge which she has never had before) in an elderly female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 004F21A) for COVID-19 vaccination.     No Medical History information was reported.    On 26-Aug-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 EYE PRURITUS (Eyes has been itching since receiving the vaccine) and EYE DISCHARGE (she had been having ocular discharge which she has never had before). At the time of the report, EYE PRURITUS (Eyes has been itching since receiving the vaccine) and EYE DISCHARGE (she had been having ocular discharge which she has never had before) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): In March 2021, COVID-19: positive (Positive) Positive. On 27-Jul-2021, Antibody test: positive (Positive) Positive.     The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No concomitant medication details was reported. No treatment medication details was reported.
Age: 44.0
Sex: F
Vaccine: COVID19
Symptoms: Chills, Cough, Fatigue, Malaise, Nausea
Clinical narrative: Pretty bad reaction like most people did, terrible reaction; Not feeling well; Coughing; Fever; Nausea/extreme nausea; Chills; Fatigue; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION COMPLICATION (Pretty bad reaction like most people did, terrible reaction), MALAISE (Not feeling well), COUGH (Coughing), PYREXIA (Fever) and NAUSEA (Nausea/extreme nausea) in a 44-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 003C21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported. .  Concomitant products included SIMVASTATIN (ZOCOR) for Cholesterol.    On 23-Jul-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 23-Jul-2021, the patient experienced VACCINATION COMPLICATION (Pretty bad reaction like most people did, terrible reaction), MALAISE (Not feeling well), COUGH (Coughing), PYREXIA (Fever), NAUSEA (Nausea/extreme nausea), CHILLS (Chills) and FATIGUE (Fatigue). On 25-Jul-2021, VACCINATION COMPLICATION (Pretty bad reaction like most people did, terrible reaction), MALAISE (Not feeling well), COUGH (Coughing), PYREXIA (Fever), NAUSEA (Nausea/extreme nausea), CHILLS (Chills) and FATIGUE (Fatigue) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   Treatment information was not provided.   This case was linked to MOD-2021-299819 (Patient Link).
Age: 44.0
Sex: F
Vaccine: COVID19
Symptoms: Pyrexia, Vaccination complication
Clinical narrative: Pretty bad reaction like most people did, terrible reaction; Not feeling well; Coughing; Fever; Nausea/extreme nausea; Chills; Fatigue; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION COMPLICATION (Pretty bad reaction like most people did, terrible reaction), MALAISE (Not feeling well), COUGH (Coughing), PYREXIA (Fever) and NAUSEA (Nausea/extreme nausea) in a 44-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 003C21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported. .  Concomitant products included SIMVASTATIN (ZOCOR) for Cholesterol.    On 23-Jul-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 23-Jul-2021, the patient experienced VACCINATION COMPLICATION (Pretty bad reaction like most people did, terrible reaction), MALAISE (Not feeling well), COUGH (Coughing), PYREXIA (Fever), NAUSEA (Nausea/extreme nausea), CHILLS (Chills) and FATIGUE (Fatigue). On 25-Jul-2021, VACCINATION COMPLICATION (Pretty bad reaction like most people did, terrible reaction), MALAISE (Not feeling well), COUGH (Coughing), PYREXIA (Fever), NAUSEA (Nausea/extreme nausea), CHILLS (Chills) and FATIGUE (Fatigue) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   Treatment information was not provided.   This case was linked to MOD-2021-299819 (Patient Link).
Age: 51.0
Sex: F
Vaccine: COVID19
Symptoms: Erythema, Fatigue, Peripheral swelling, Skin warm
Clinical narrative: hot to the touch; tiredness, tired; size of a tennis ball; got really red; This spontaneous case was reported by a consumer and describes the occurrence of PERIPHERAL SWELLING (size of a tennis ball), ERYTHEMA (got really red), SKIN WARM (hot to the touch) and FATIGUE (tiredness, tired) in a 51-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. Not available) for COVID-19 vaccination.     The patient's past medical history included Pneumonia. Concomitant products included DULOXETINE and DULOXETINE HYDROCHLORIDE (CYMBALTA) for an unknown indication.    On 01-Aug-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. In August 2021, the patient experienced PERIPHERAL SWELLING (size of a tennis ball), ERYTHEMA (got really red) and FATIGUE (tiredness, tired). On an unknown date, the patient experienced SKIN WARM (hot to the touch). At the time of the report, PERIPHERAL SWELLING (size of a tennis ball), ERYTHEMA (got really red), SKIN WARM (hot to the touch) and FATIGUE (tiredness, tired) 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.   Patient is taking concomitant medications :Blood pressure medication pill ,Thyroid pill patient had COVID in December Treatment information was not provided
Sex: U
Vaccine: COVID19
Symptoms: Body temperature, Feeling hot, Pyrexia
Clinical narrative: Just feeling really hot; Had the booster shot have a fever of 100.5; This spontaneous case was reported by a consumer and describes the occurrence of FEELING HOT (Just feeling really hot) and PYREXIA (Had the booster shot have a fever of 100.5) 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 third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced FEELING HOT (Just feeling really hot) and PYREXIA (Had the booster shot have a fever of 100.5). At the time of the report, FEELING HOT (Just feeling really hot) and PYREXIA (Had the booster shot have a fever of 100.5) had resolved.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, Body temperature: 100.5 (High) 100.5.         No concomitant medication was provided. No treatment  medication was provided.   Most recent FOLLOW-UP information incorporated above includes: On 30-Aug-2021: Additional document received, outcome updated to recovered.
Age: 51.0
Sex: F
Vaccine: COVID19
Symptoms: Blood pressure measurement, Body temperature, Headache, Malaise, Myalgia
Clinical narrative: Not feeling well; Severe body aches all over; Headache; This spontaneous case was reported by a consumer and describes the occurrence of MALAISE (Not feeling well), MYALGIA (Severe body aches all over) and HEADACHE (Headache) in a 51-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 036B21A) for COVID-19 vaccination.     Concurrent medical conditions included Hashimoto's disease.    On 26-Aug-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. In August 2021, the patient experienced MALAISE (Not feeling well), MYALGIA (Severe body aches all over) and HEADACHE (Headache). At the time of the report, MALAISE (Not feeling well), MYALGIA (Severe body aches all over) and HEADACHE (Headache) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 27-Aug-2021, Blood pressure measurement: high (High) A little high. On 27-Aug-2021, Body temperature: 101.3 (High) 101.3F at 4:40am.     The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       Concomitant product use was not provided.   Treatment information was not provided.
Age: 71.0
Sex: F
Vaccine: COVID19
Symptoms: Interchange of vaccine products, Pyrexia
Clinical narrative: 1st dose sinovac-2nd dose Moderna; Felt feverish; This spontaneous case was reported by a consumer and describes the occurrence of INTERCHANGE OF VACCINE PRODUCTS (1st dose sinovac-2nd dose Moderna) and PYREXIA (Felt feverish) in a 71-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. unknown) for COVID-19 vaccination.    Co-suspect product included non-company product COVID-19 VACCINE for COVID-19 vaccination.    Concurrent medical conditions included Thyroid cancer.   On 28-Jul-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient started COVID-19 VACCINE (unknown route) 1 dosage form(s). On 28-Jul-2021, the patient experienced INTERCHANGE OF VACCINE PRODUCTS (1st dose sinovac-2nd dose Moderna) and PYREXIA (Felt feverish). At the time of the report, INTERCHANGE OF VACCINE PRODUCTS (1st dose sinovac-2nd dose Moderna) had resolved and PYREXIA (Felt feverish) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       Concomitant medications were not provided by the reporter.  Treatment medication was  not reported.  The patient had 1st dose Sinovac marzo 2021, 2nd dose Moderna and was going to have the third dose.
Age: 34.0
Sex: F
Vaccine: COVID19
Symptoms: Anosmia, Chest discomfort, Chest pain, Cough, Diarrhoea
Clinical narrative: became extremely ill/sick; is still not well; coughing; chest condition/feels pressure; Chest pain when she coughs/short stinging pain; loss of smell/cannot smell anything; runny nose; diarrhea; chest congestion; fever; maternal exposure during breast feeding; This spontaneous case was reported by a consumer and describes the occurrence of ILLNESS (became extremely ill/sick), MALAISE (is still not well), COUGH (coughing), CHEST DISCOMFORT (chest condition/feels pressure) and CHEST PAIN (Chest pain when she coughs/short stinging pain) in a 34-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 040C21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.   On 20-Aug-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 ILLNESS (became extremely ill/sick), MALAISE (is still not well), COUGH (coughing), CHEST DISCOMFORT (chest condition/feels pressure), CHEST PAIN (Chest pain when she coughs/short stinging pain), ANOSMIA (loss of smell/cannot smell anything), RHINORRHOEA (runny nose), DIARRHOEA (diarrhea), RESPIRATORY TRACT CONGESTION (chest congestion), PYREXIA (fever) and MATERNAL EXPOSURE DURING BREAST FEEDING (maternal exposure during breast feeding). The patient was treated with PARACETAMOL (TYLENOL) for Fever, at an unspecified dose and frequency and IBUPROFEN for Fever, at an unspecified dose and frequency. At the time of the report, ILLNESS (became extremely ill/sick), MALAISE (is still not well), COUGH (coughing), CHEST DISCOMFORT (chest condition/feels pressure), CHEST PAIN (Chest pain when she coughs/short stinging pain), ANOSMIA (loss of smell/cannot smell anything), RHINORRHOEA (runny nose), DIARRHOEA (diarrhea), RESPIRATORY TRACT CONGESTION (chest congestion) and PYREXIA (fever) was resolving and MATERNAL EXPOSURE DURING BREAST FEEDING (maternal exposure during breast feeding) had resolved.      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.   There was no information regarding ECG, cardiac test, cardiac enzyme. There is no history of COVID-19 infection concomitant medications were not provided. other treatment medications include sinus medication taken for coughing and congestion   This case was linked to MOD-2021-300395 (Parent-Child Link).   See case MOD-2021-300395 for details regarding the child case.
Age: 34.0
Sex: F
Vaccine: COVID19
Symptoms: Illness, Malaise, Maternal exposure during breast feeding, Pyrexia, Respiratory tract congestion
Clinical narrative: became extremely ill/sick; is still not well; coughing; chest condition/feels pressure; Chest pain when she coughs/short stinging pain; loss of smell/cannot smell anything; runny nose; diarrhea; chest congestion; fever; maternal exposure during breast feeding; This spontaneous case was reported by a consumer and describes the occurrence of ILLNESS (became extremely ill/sick), MALAISE (is still not well), COUGH (coughing), CHEST DISCOMFORT (chest condition/feels pressure) and CHEST PAIN (Chest pain when she coughs/short stinging pain) in a 34-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 040C21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.   On 20-Aug-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 ILLNESS (became extremely ill/sick), MALAISE (is still not well), COUGH (coughing), CHEST DISCOMFORT (chest condition/feels pressure), CHEST PAIN (Chest pain when she coughs/short stinging pain), ANOSMIA (loss of smell/cannot smell anything), RHINORRHOEA (runny nose), DIARRHOEA (diarrhea), RESPIRATORY TRACT CONGESTION (chest congestion), PYREXIA (fever) and MATERNAL EXPOSURE DURING BREAST FEEDING (maternal exposure during breast feeding). The patient was treated with PARACETAMOL (TYLENOL) for Fever, at an unspecified dose and frequency and IBUPROFEN for Fever, at an unspecified dose and frequency. At the time of the report, ILLNESS (became extremely ill/sick), MALAISE (is still not well), COUGH (coughing), CHEST DISCOMFORT (chest condition/feels pressure), CHEST PAIN (Chest pain when she coughs/short stinging pain), ANOSMIA (loss of smell/cannot smell anything), RHINORRHOEA (runny nose), DIARRHOEA (diarrhea), RESPIRATORY TRACT CONGESTION (chest congestion) and PYREXIA (fever) was resolving and MATERNAL EXPOSURE DURING BREAST FEEDING (maternal exposure during breast feeding) had resolved.      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.   There was no information regarding ECG, cardiac test, cardiac enzyme. There is no history of COVID-19 infection concomitant medications were not provided. other treatment medications include sinus medication taken for coughing and congestion   This case was linked to MOD-2021-300395 (Parent-Child Link).   See case MOD-2021-300395 for details regarding the child case.
Age: 34.0
Sex: F
Vaccine: COVID19
Symptoms: Rhinorrhoea
Clinical narrative: became extremely ill/sick; is still not well; coughing; chest condition/feels pressure; Chest pain when she coughs/short stinging pain; loss of smell/cannot smell anything; runny nose; diarrhea; chest congestion; fever; maternal exposure during breast feeding; This spontaneous case was reported by a consumer and describes the occurrence of ILLNESS (became extremely ill/sick), MALAISE (is still not well), COUGH (coughing), CHEST DISCOMFORT (chest condition/feels pressure) and CHEST PAIN (Chest pain when she coughs/short stinging pain) in a 34-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 040C21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.   On 20-Aug-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 ILLNESS (became extremely ill/sick), MALAISE (is still not well), COUGH (coughing), CHEST DISCOMFORT (chest condition/feels pressure), CHEST PAIN (Chest pain when she coughs/short stinging pain), ANOSMIA (loss of smell/cannot smell anything), RHINORRHOEA (runny nose), DIARRHOEA (diarrhea), RESPIRATORY TRACT CONGESTION (chest congestion), PYREXIA (fever) and MATERNAL EXPOSURE DURING BREAST FEEDING (maternal exposure during breast feeding). The patient was treated with PARACETAMOL (TYLENOL) for Fever, at an unspecified dose and frequency and IBUPROFEN for Fever, at an unspecified dose and frequency. At the time of the report, ILLNESS (became extremely ill/sick), MALAISE (is still not well), COUGH (coughing), CHEST DISCOMFORT (chest condition/feels pressure), CHEST PAIN (Chest pain when she coughs/short stinging pain), ANOSMIA (loss of smell/cannot smell anything), RHINORRHOEA (runny nose), DIARRHOEA (diarrhea), RESPIRATORY TRACT CONGESTION (chest congestion) and PYREXIA (fever) was resolving and MATERNAL EXPOSURE DURING BREAST FEEDING (maternal exposure during breast feeding) had resolved.      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.   There was no information regarding ECG, cardiac test, cardiac enzyme. There is no history of COVID-19 infection concomitant medications were not provided. other treatment medications include sinus medication taken for coughing and congestion   This case was linked to MOD-2021-300395 (Parent-Child Link).   See case MOD-2021-300395 for details regarding the child case.
Age: 60.0
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, Drug ineffective, Malaise, Pain, Rhinorrhoea
Clinical narrative: aching; runny nose; malaise; got tested positive for covid-19; Lack of drug effect; This spontaneous case was reported by a consumer and describes the occurrence of COVID-19 (got tested positive for covid-19), DRUG INEFFECTIVE (Lack of drug effect), PAIN (aching), RHINORRHOEA (runny nose) and MALAISE (malaise) in a 60-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 015M20H and 027L20A) for COVID-19 vaccination.     No Medical History information was reported.   On 06-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 05-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 14-Aug-2021, the patient experienced COVID-19 (got tested positive for covid-19) and DRUG INEFFECTIVE (Lack of drug effect). On an unknown date, the patient experienced PAIN (aching), RHINORRHOEA (runny nose) and MALAISE (malaise). At the time of the report, COVID-19 (got tested positive for covid-19), DRUG INEFFECTIVE (Lack of drug effect), PAIN (aching), RHINORRHOEA (runny nose) and MALAISE (malaise) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 14-Aug-2021, SARS-CoV-2 test: positive (Positive) COVID-19 Virus test was positive.         The concomitant medications information was not reported. Treatment information was not provided.     Most recent FOLLOW-UP information incorporated above includes: On 02-Sep-2021: Follow up information included additional events.; 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. However, based on the mechanism of action of mRNA-1273, causal association between the event of COVID-19 infection  and mRNA-1273 is assessed as not applicable.
Age: 60.0
Sex: F
Vaccine: COVID19
Symptoms: SARS-CoV-2 test
Clinical narrative: aching; runny nose; malaise; got tested positive for covid-19; Lack of drug effect; This spontaneous case was reported by a consumer and describes the occurrence of COVID-19 (got tested positive for covid-19), DRUG INEFFECTIVE (Lack of drug effect), PAIN (aching), RHINORRHOEA (runny nose) and MALAISE (malaise) in a 60-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 015M20H and 027L20A) for COVID-19 vaccination.     No Medical History information was reported.   On 06-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 05-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 14-Aug-2021, the patient experienced COVID-19 (got tested positive for covid-19) and DRUG INEFFECTIVE (Lack of drug effect). On an unknown date, the patient experienced PAIN (aching), RHINORRHOEA (runny nose) and MALAISE (malaise). At the time of the report, COVID-19 (got tested positive for covid-19), DRUG INEFFECTIVE (Lack of drug effect), PAIN (aching), RHINORRHOEA (runny nose) and MALAISE (malaise) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 14-Aug-2021, SARS-CoV-2 test: positive (Positive) COVID-19 Virus test was positive.         The concomitant medications information was not reported. Treatment information was not provided.     Most recent FOLLOW-UP information incorporated above includes: On 02-Sep-2021: Follow up information included additional events.; 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. However, based on the mechanism of action of mRNA-1273, causal association between the event of COVID-19 infection  and mRNA-1273 is assessed as not applicable.
Age: 53.0
Sex: F
Vaccine: COVID19
Symptoms: Chills, Fatigue, Headache, Pain in extremity
Clinical narrative: chills; fatigue; headache; pain in the arm; This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (pain in the arm), CHILLS (chills), FATIGUE (fatigue) and HEADACHE (headache) in a 53-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 091D21A) for COVID-19 vaccination.     No Medical History information was reported.    On 16-Aug-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 PAIN IN EXTREMITY (pain in the arm), CHILLS (chills), FATIGUE (fatigue) and HEADACHE (headache). At the time of the report, PAIN IN EXTREMITY (pain in the arm) had resolved and CHILLS (chills), FATIGUE (fatigue) 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: 44.0
Sex: U
Vaccine: COVID19
Symptoms: Cough, Dyspnoea, Fatigue, Feeling of body temperature change, Headache
Clinical narrative: I feel short of breath; feel tired; headaches; body ache; I've been hot and cold; Dry cough; This spontaneous case was reported by a consumer and describes the occurrence of FEELING OF BODY TEMPERATURE CHANGE (I've been hot and cold), COUGH (Dry cough), DYSPNOEA (I feel short of breath), MYALGIA (body ache) and FATIGUE (feel tired) in a 44-year-old patient of an unknown gender who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 939902) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     The patient's past medical history included Anxiety, Depression, Migraine and Sleep disorder.   On 24-Aug-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 25-Aug-2021, the patient experienced FEELING OF BODY TEMPERATURE CHANGE (I've been hot and cold), COUGH (Dry cough), MYALGIA (body ache) and HEADACHE (headaches). On 26-Aug-2021, the patient experienced DYSPNOEA (I feel short of breath) and FATIGUE (feel tired). At the time of the report, FEELING OF BODY TEMPERATURE CHANGE (I've been hot and cold), COUGH (Dry cough), DYSPNOEA (I feel short of breath), MYALGIA (body ache), FATIGUE (feel tired) and HEADACHE (headaches) outcome was unknown.      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.   No treatment medication was reported by patient.  Patient reported concomitant medication for anxiety, depression, migraines and sleep.  Patient reported no history of COVID-19 infection nor history of myocarditis and pericarditis.
Age: 44.0
Sex: U
Vaccine: COVID19
Symptoms: Myalgia
Clinical narrative: I feel short of breath; feel tired; headaches; body ache; I've been hot and cold; Dry cough; This spontaneous case was reported by a consumer and describes the occurrence of FEELING OF BODY TEMPERATURE CHANGE (I've been hot and cold), COUGH (Dry cough), DYSPNOEA (I feel short of breath), MYALGIA (body ache) and FATIGUE (feel tired) in a 44-year-old patient of an unknown gender who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 939902) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     The patient's past medical history included Anxiety, Depression, Migraine and Sleep disorder.   On 24-Aug-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 25-Aug-2021, the patient experienced FEELING OF BODY TEMPERATURE CHANGE (I've been hot and cold), COUGH (Dry cough), MYALGIA (body ache) and HEADACHE (headaches). On 26-Aug-2021, the patient experienced DYSPNOEA (I feel short of breath) and FATIGUE (feel tired). At the time of the report, FEELING OF BODY TEMPERATURE CHANGE (I've been hot and cold), COUGH (Dry cough), DYSPNOEA (I feel short of breath), MYALGIA (body ache), FATIGUE (feel tired) and HEADACHE (headaches) outcome was unknown.      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.   No treatment medication was reported by patient.  Patient reported concomitant medication for anxiety, depression, migraines and sleep.  Patient reported no history of COVID-19 infection nor history of myocarditis and pericarditis.
Sex: U
Vaccine: COVID19
Symptoms: Expired product administered
Clinical narrative: I have a nurse that administered a moderna dose today but the 30 day expiration date was on 8/24; This spontaneous case was reported by a pharmacist and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (I have a nurse that administered a moderna dose today but the 30 day expiration date was on 8/24) 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 August 2021, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced EXPIRED PRODUCT ADMINISTERED (I have a nurse that administered a moderna dose today but the 30 day expiration date was on 8/24). At the time of the report, EXPIRED PRODUCT ADMINISTERED (I have a nurse that administered a moderna dose today but the 30 day expiration date was on 8/24) had resolved.            Concomitant medication was not provided treatment information was not provided   Reporter did not allow further contact
Sex: U
Vaccine: COVID19
Symptoms: Expired product administered
Clinical narrative: Received expired vaccine beyond manufacturer's expiration date; Based on the current case data, this case has been classified as invalid. This spontaneous case was reported by a nurse and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Received expired vaccine beyond manufacturer's expiration date) in a patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 026A21A) for COVID-19 vaccination.     No Medical History information was reported.    On 27-Aug-2021, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 27-Aug-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (Received expired vaccine beyond manufacturer's expiration date). On 27-Aug-2021, EXPIRED PRODUCT ADMINISTERED (Received expired vaccine beyond manufacturer's expiration date) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No Concomitant Medications were reported No Treatment Medications were reported.
Age: 75.0
Sex: M
Vaccine: COVID19
Symptoms: Chills, Hypersomnia, Pain, Pyrexia
Clinical narrative: Aches and pains; Slept a lot; Fever; Chills; This spontaneous case was reported by a consumer and describes the occurrence of PAIN (Aches and pains), HYPERSOMNIA (Slept a lot), PYREXIA (Fever) and CHILLS (Chills) in a 75-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 006M20A and 025L20A) for COVID-19 vaccination.     No Medical History information was reported.   On 14-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 11-Feb-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 PAIN (Aches and pains), HYPERSOMNIA (Slept a lot), PYREXIA (Fever) and CHILLS (Chills). At the time of the report, PAIN (Aches and pains), HYPERSOMNIA (Slept a lot), PYREXIA (Fever) and CHILLS (Chills) had resolved.        No concomitant medications were provided. No treatment medications were reported.
Age: 14.0
Sex: M
Vaccine: COVID19
Symptoms: Product administered to patient of inappropriate age
Clinical narrative: We gave a 14 year old the Moderna Shot; This spontaneous case was reported by an other health care professional and describes the occurrence of PRODUCT ADMINISTERED TO PATIENT OF INAPPROPRIATE AGE (We gave a 14 year old the Moderna Shot) in a 14-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 059E21A) for COVID-19 vaccination.     No Medical History information was reported.    On 29-Jul-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 29-Jul-2021, the patient experienced PRODUCT ADMINISTERED TO PATIENT OF INAPPROPRIATE AGE (We gave a 14 year old the Moderna Shot). On 29-Jul-2021, PRODUCT ADMINISTERED TO PATIENT OF INAPPROPRIATE AGE (We gave a 14 year old the Moderna Shot) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant medications were reported. No treatment medications were reported.
Sex: M
Vaccine: COVID19
Symptoms: Headache, Pyrexia
Clinical narrative: general fever after the second dose; little headache after the second dose; This spontaneous case was reported by a consumer and describes the occurrence of PYREXIA (general fever after the second dose) and HEADACHE (little headache after the second dose) 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 second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced PYREXIA (general fever after the second dose) and HEADACHE (little headache after the second dose). The patient was treated with PARACETAMOL (TYLENOL) for Adverse event, at an unspecified dose and frequency. At the time of the report, PYREXIA (general fever after the second dose) and HEADACHE (little headache after the second dose) had resolved.            Concomitant medication was not provided.  as treatment the patient took tylenol, and drinking water for the fever.  it was stated that the patient had the general fever and a little headache, but it went away after a day.     This case was linked to MOD-2021-300002 (Patient Link).
Sex: U
Vaccine: COVID19
Symptoms: Blood disorder
Clinical narrative: blood cells dieing; 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 BLOOD DISORDER (blood cells dieing) 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 BLOOD DISORDER (blood cells dieing). At the time of the report, BLOOD DISORDER (blood cells dieing) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       Concomitant product use was not provided by the reporter.   Treatment information was not provided
Age: 58.0
Sex: M
Vaccine: COVID19
Symptoms: Antibody test, Dyspnoea, Myalgia, Product dose omission issue
Clinical narrative: Difficult to breath/some breathing issues; The patient scared to get the second shot; Body aches; This spontaneous case was reported by a consumer and describes the occurrence of DYSPNOEA (Difficult to breath/some breathing issues), MYALGIA (Body aches) and PRODUCT DOSE OMISSION ISSUE (The patient scared to get the second shot) in a 58-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On 19-Jul-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 19-Jul-2021, the patient experienced MYALGIA (Body aches). On an unknown date, the patient experienced DYSPNOEA (Difficult to breath/some breathing issues) and PRODUCT DOSE OMISSION ISSUE (The patient scared to get the second shot). On 21-Jul-2021, MYALGIA (Body aches) had resolved. At the time of the report, DYSPNOEA (Difficult to breath/some breathing issues) and PRODUCT DOSE OMISSION ISSUE (The patient scared to get the second shot) had resolved.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, Antibody test: negative (Negative) Negative.     The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No relevant concomitant medications were reported. Treatment information was not provided.  Patient mentioned that  they have no heart issues.
Age: 69.0
Sex: M
Vaccine: COVID19
Symptoms: Expired product administered
Clinical narrative: This spontaneous case reported by a pharmacist, describes the occurrence of administered expired product (used a vial first punctured yesterday on Aug 26, 2021 at 8:28 am) in a 69-year-old male patient who received mRNA-1273 (Moderna COVID-19 vaccine, batch# unknown) for COVID-19 immunization. No medical history reported. On an unknown date, patient received the third dose of mRNA-1273 (Moderna COVID-19 vaccine), unknown route; 1 dosage form. On Aug 27, 2021, patient administered expired product (used a vial first punctured yesterday on Aug 26, 2021 at 8:28 am). On Aug 27, 2021, administered expired product (used a vial first punctured yesterday on Aug 26, 2021 at 8:28 am): resolved. The reporter did not provide any causality assessments, concomitant product use or treatment information.
Sex: F
Vaccine: COVID19
Symptoms: Pain
Clinical narrative: a lot of pain, All over her body, saying she can feel every muscle and organ.; This spontaneous case was reported by a consumer and describes the occurrence of PAIN (a lot of pain, All over her body, saying she can feel every muscle and organ.) 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 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 PAIN (a lot of pain, All over her body, saying she can feel every muscle and organ.). At the time of the report, PAIN (a lot of pain, All over her body, saying she can feel every muscle and organ.) outcome was unknown.            Concomitant medication details were not reported by the reporter. Treatment details was not reported by the reporter.
Age: 62.0
Sex: F
Vaccine: COVID19
Symptoms: Arthralgia, Chills, Feeling cold, Feeling hot, Headache
Clinical narrative: feeling real hot; feel sweaty and that they didn't sleep; Feeling real cold; they had chills; experiencing severe headache,massive headache; fever; they cant sleep; pain in the arm; their joint hurt; nausea; This spontaneous case was reported by a consumer and describes the occurrence of INSOMNIA (they cant sleep), VACCINATION SITE PAIN (pain in the arm), FEELING HOT (feeling real hot), HYPERHIDROSIS (feel sweaty and that they didn't sleep) and FEELING COLD (Feeling real cold) in a 62-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 00521a and 043l20a) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     Concurrent medical conditions included Hypertension (Hypertension).   On 26-Aug-2021, the patient 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 received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. In August 2021, the patient experienced VACCINATION SITE PAIN (pain in the arm), ARTHRALGIA (their joint hurt) and NAUSEA (nausea). On 26-Aug-2021, the patient experienced INSOMNIA (they cant sleep), FEELING HOT (feeling real hot), HYPERHIDROSIS (feel sweaty and that they didn't sleep), FEELING COLD (Feeling real cold), CHILLS (they had chills), HEADACHE (experiencing severe headache,massive headache) and PYREXIA (fever). The patient was treated with PARACETAMOL (TYLENOL) at an unspecified dose and frequency. On 26-Aug-2021, HYPERHIDROSIS (feel sweaty and that they didn't sleep) had resolved. At the time of the report, INSOMNIA (they cant sleep), VACCINATION SITE PAIN (pain in the arm), FEELING HOT (feeling real hot), FEELING COLD (Feeling real cold), CHILLS (they had chills), PYREXIA (fever), ARTHRALGIA (their joint hurt) and NAUSEA (nausea) outcome was unknown and HEADACHE (experiencing severe headache,massive headache) had not resolved.            The patient received 3rd dose of COVID-19 vaccination and experienced events, patient concomitants include high blood pressure medication and vitamins and started taking Tylenol for side effects.   This case was linked to MOD-2021-300932 (Patient Link).
Age: 62.0
Sex: F
Vaccine: COVID19
Symptoms: Hyperhidrosis, Insomnia, Nausea, Pyrexia, Vaccination site pain
Clinical narrative: feeling real hot; feel sweaty and that they didn't sleep; Feeling real cold; they had chills; experiencing severe headache,massive headache; fever; they cant sleep; pain in the arm; their joint hurt; nausea; This spontaneous case was reported by a consumer and describes the occurrence of INSOMNIA (they cant sleep), VACCINATION SITE PAIN (pain in the arm), FEELING HOT (feeling real hot), HYPERHIDROSIS (feel sweaty and that they didn't sleep) and FEELING COLD (Feeling real cold) in a 62-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 00521a and 043l20a) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     Concurrent medical conditions included Hypertension (Hypertension).   On 26-Aug-2021, the patient 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 received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. In August 2021, the patient experienced VACCINATION SITE PAIN (pain in the arm), ARTHRALGIA (their joint hurt) and NAUSEA (nausea). On 26-Aug-2021, the patient experienced INSOMNIA (they cant sleep), FEELING HOT (feeling real hot), HYPERHIDROSIS (feel sweaty and that they didn't sleep), FEELING COLD (Feeling real cold), CHILLS (they had chills), HEADACHE (experiencing severe headache,massive headache) and PYREXIA (fever). The patient was treated with PARACETAMOL (TYLENOL) at an unspecified dose and frequency. On 26-Aug-2021, HYPERHIDROSIS (feel sweaty and that they didn't sleep) had resolved. At the time of the report, INSOMNIA (they cant sleep), VACCINATION SITE PAIN (pain in the arm), FEELING HOT (feeling real hot), FEELING COLD (Feeling real cold), CHILLS (they had chills), PYREXIA (fever), ARTHRALGIA (their joint hurt) and NAUSEA (nausea) outcome was unknown and HEADACHE (experiencing severe headache,massive headache) had not resolved.            The patient received 3rd dose of COVID-19 vaccination and experienced events, patient concomitants include high blood pressure medication and vitamins and started taking Tylenol for side effects.   This case was linked to MOD-2021-300932 (Patient Link).
Sex: U
Vaccine: COVID19
Symptoms: Fatigue, Muscle spasms
Clinical narrative: Muscle cramps; Fatigue; This spontaneous case was reported by a consumer and describes the occurrence of MUSCLE SPASMS (Muscle cramps) and FATIGUE (Fatigue) 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 27-Aug-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 MUSCLE SPASMS (Muscle cramps) and FATIGUE (Fatigue). At the time of the report, MUSCLE SPASMS (Muscle cramps) and FATIGUE (Fatigue) outcome was unknown.            Treatment history was not reported.The concomitant medication was not reported. Patient took booster dose.
Sex: F
Vaccine: COVID19
Symptoms: Erythema, Superficial vein thrombosis
Clinical narrative: Superficial thrombosis; Redness in her leg 3 days after her second shot; This spontaneous case was reported by a consumer and describes the occurrence of ERYTHEMA (Redness in her leg 3 days after her second shot) and THROMBOPHLEBITIS SUPERFICIAL (Superficial thrombosis) 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 13-Aug-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 16-Aug-2021, the patient experienced ERYTHEMA (Redness in her leg 3 days after her second shot). On an unknown date, the patient experienced THROMBOPHLEBITIS SUPERFICIAL (Superficial thrombosis). At the time of the report, ERYTHEMA (Redness in her leg 3 days after her second shot) and THROMBOPHLEBITIS SUPERFICIAL (Superficial thrombosis) outcome was unknown.        No relevant concomitant medications were reported.  No treatment information was provided.