chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 38.0
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, Maternal exposure during pregnancy, Pregnancy test, SARS-CoV-2 test positive
Clinical narrative: Pregnant; Tested positive for covid; This spontaneous prospective pregnancy case was reported by a consumer and describes the occurrence of MATERNAL EXPOSURE DURING PREGNANCY (Pregnant) and SARS-COV-2 TEST POSITIVE (Tested positive for covid) in a 38-year-old female patient (gravida 2, para 2) who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On 09-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. The patient's last menstrual period was on 22-Jun-2020 and the estimated date of delivery was 29-Mar-2021. On 09-Jan-2021, the patient experienced MATERNAL EXPOSURE DURING PREGNANCY (Pregnant) and SARS-COV-2 TEST POSITIVE (Tested positive for covid). The patient received mRNA-1273 (Moderna COVID-19 Vaccine) beginning around the  twenty-eighth week of the pregnancy. The delivery occurred  on 30-Mar-2021, which was reported as Unknown. For neonate 1, The outcome was reported as Unknown. On 09-Jan-2021, MATERNAL EXPOSURE DURING PREGNANCY (Pregnant) had resolved. At the time of the report, SARS-COV-2 TEST POSITIVE (Tested positive for covid) outcome was unknown. Not Provided    DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 11-Jan-2021, COVID-19: positive (Positive) positive. On 06-Jul-2021, Pregnancy test: positive (Positive) Tested positive on 13 Jan 2021..     The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Concomitant medications were not provided by the reporter. Past pregnancy data included: Live birth, no complications delivered at 41 weeks. No treatment information was provided.   Most recent FOLLOW-UP information incorporated above includes: On 14-Apr-2021: follow up received and contains EDD date ,delivery date
Age: 33.0
Sex: F
Vaccine: COVID19
Symptoms: Maternal exposure during pregnancy, Pregnancy test
Clinical narrative: Pregnant patient received the first dose; This spontaneous prospective pregnancy case was reported by a consumer and describes the occurrence of MATERNAL EXPOSURE DURING PREGNANCY (Pregnant patient received the first dose) in a 33-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 042L20A) for COVID-19 vaccination.     Concurrent medical conditions included Asthma.    On 20-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. The patient's last menstrual period was on 11-Jun-2020 and the estimated date of delivery was 23-Mar-2021. On 20-Jan-2021, the patient experienced MATERNAL EXPOSURE DURING PREGNANCY (Pregnant patient received the first dose). The patient received mRNA-1273 (Moderna COVID-19 Vaccine) beginning around the  thirty-first week of the pregnancy. The delivery occurred on an unknown date, which was reported as Unknown. For neonate 1, The outcome was reported as Unknown. On 20-Jan-2021, MATERNAL EXPOSURE DURING PREGNANCY (Pregnant patient received the first dose) had resolved.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): In July 2020, Pregnancy test: positive (Positive) Positive.     The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No concomitant medication was provided. No treatment medication was provided.; Reporter's Comments: This is a case of product exposure during pregnancy with no associated AEs for this 33-year-old female. Patient will continue to be contacted for further monitoring of AEs during the pregnancy.
Sex: F
Vaccine: COVID19
Symptoms: Maternal exposure during pregnancy
Clinical narrative: Pregnancy; This spontaneous prospective pregnancy case was reported by a consumer and describes the occurrence of MATERNAL EXPOSURE DURING PREGNANCY (Pregnancy) 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. Last menstrual period and estimated date of delivery were not provided. On an unknown date, the patient experienced MATERNAL EXPOSURE DURING PREGNANCY (Pregnancy). At the time of the report, MATERNAL EXPOSURE DURING PREGNANCY (Pregnancy) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       Concomitant medications were not reported. Treatment medications were not reported.
Sex: F
Vaccine: COVID19
Symptoms: Pruritus, Vaccination site pruritus
Clinical narrative: itches in her legs; Itchy at injection site; This spontaneous case was reported by a consumer and describes the occurrence of PRURITUS (itches in her legs) and VACCINATION SITE PRURITUS (Itchy at injection site) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 039K20A) for COVID-19 vaccination.     No Medical History information was reported.    On 11-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 11-Jan-2021, the patient experienced PRURITUS (itches in her legs) and VACCINATION SITE PRURITUS (Itchy at injection site). At the time of the report, PRURITUS (itches in her legs) and VACCINATION SITE PRURITUS (Itchy at injection site) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       Concomitant medication was not reported.  No treatment information was provided.   Reporter did not allow further contact; Sender's Comments: Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded
Age: 48.0
Sex: M
Vaccine: COVID19
Symptoms: COVID-19, Chills, Pyrexia, SARS-CoV-2 test positive
Clinical narrative: rapid test positive for COVID-19; 101-102°F fever; chills; This spontaneous case was reported by a consumer and describes the occurrence of SARS-COV-2 TEST POSITIVE (rapid test positive for COVID-19), PYREXIA (101-102°F fever) and CHILLS (chills) in a 48-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 011L20A) for COVID-19 vaccination.     Concurrent medical conditions included Hypertension since 15-Jan-2021 and COVID-19 since 15-Jan-2021.    On 14-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 14-Jan-2021, the patient experienced PYREXIA (101-102°F fever) and CHILLS (chills). On 15-Jan-2021, the patient experienced SARS-COV-2 TEST POSITIVE (rapid test positive for COVID-19). The patient was treated with PARACETAMOL (TYLENOL) at an unspecified dose and frequency and IBUPROFEN (ADVIL [IBUPROFEN]) at an unspecified dose and frequency. On 15-Jan-2021, PYREXIA (101-102°F fever) and CHILLS (chills) had resolved. At the time of the report, SARS-COV-2 TEST POSITIVE (rapid test positive for COVID-19) had not resolved.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 15-Jan-2021, COVID-19: Positive.     The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       He took Tylenol and Advil for the symptoms. He takes blood pressure medicines as a chronic treatment.; Sender's Comments: Based on the current available information and temporal association between the use of the product and the start date of Pyrexia and chills, a causal relationship cannot be excluded. Based on the current available information SARS-CoV-2 test positive is unlikely related to vaccine per recent agreements, the event is assessed as unlikely related to mRNA-1273.
Sex: F
Vaccine: COVID19
Symptoms: Arthralgia, Vaccination site erythema, Vaccination site pain, Vaccination site swelling
Clinical narrative: Vaccination site swelling; Redness on the injection site; Vaccination site pain; Shoulder on the side of the injection was in pain; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE SWELLING (Vaccination site swelling), VACCINATION SITE ERYTHEMA (Redness on the injection site), VACCINATION SITE PAIN (Vaccination site pain) and ARTHRALGIA (Shoulder on the side of the injection was in pain) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 042620A) for COVID-19 vaccination.     The patient's past medical history included No adverse event.    On 05-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 18-Jan-2021, the patient experienced VACCINATION SITE SWELLING (Vaccination site swelling), VACCINATION SITE ERYTHEMA (Redness on the injection site), VACCINATION SITE PAIN (Vaccination site pain) and ARTHRALGIA (Shoulder on the side of the injection was in pain). At the time of the report, VACCINATION SITE SWELLING (Vaccination site swelling), VACCINATION SITE ERYTHEMA (Redness on the injection site), VACCINATION SITE PAIN (Vaccination site pain) and ARTHRALGIA (Shoulder on the side of the injection was in pain) outcome was unknown. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown Route) was unknown.       treatment and concomitant medications were not provided by reporter.
Age: 69.0
Sex: F
Vaccine: COVID19
Symptoms: Fatigue, Influenza like illness, Lip swelling, Pain in extremity
Clinical narrative: Tired; Upper lip in left side swollen; Aches; Flu kind of thing; This spontaneous case was reported by a consumer (subsequently medically confirmed) and describes the occurrence of PAIN IN EXTREMITY (Aches), INFLUENZA LIKE ILLNESS (Flu kind of thing), FATIGUE (Tired) and LIP SWELLING (Upper lip in left side swollen) in a 69-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     The patient's past medical history included No adverse event (patient says that she has not known allergies or medical conditions, she states she is quiet healthy.). Concomitant products included ESCITALOPRAM OXALATE (LEXAPRO) and OMEPRAZOLE (OMEPRAZOL 1 A PHARMA) for an unknown indication.    On 13-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1. On 14-Jan-2021, the patient experienced PAIN IN EXTREMITY (Aches) and INFLUENZA LIKE ILLNESS (Flu kind of thing). On 15-Jan-2021, the patient experienced FATIGUE (Tired) and LIP SWELLING (Upper lip in left side swollen). On 15-Jan-2021, PAIN IN EXTREMITY (Aches) outcome was unknown. At the time of the report, FATIGUE (Tired) and LIP SWELLING (Upper lip in left side swollen) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       Treatment for the event was that patient spoken to her plastic surgeon who told her that she received fillers for the last time about a year ago, and prescribed steroids to treat the swollen lip.   Patients concomitant medication include statin 40 mg.; 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: 50.0
Sex: M
Vaccine: COVID19
Symptoms: Asthenia, Chills, Injection site erythema, Injection site pain, Pyrexia
Clinical narrative: Erythema at the injection site; Tenderness/Pain at the injection site; Weakness; Internal fever; Chills; This spontaneous case was reported by a patient and describes the occurrence of INJECTION SITE ERYTHEMA (Erythema at the injection site), INJECTION SITE PAIN (Tenderness/Pain at the injection site), ASTHENIA (Weakness), PYREXIA (Internal fever) and CHILLS (Chills) in a 50-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. D11J20A) for COVID-19 vaccination.     Concurrent medical conditions included Drug allergy, Seafood allergy and Drug intolerance.    On 14-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 14-Jan-2021, the patient experienced INJECTION SITE ERYTHEMA (Erythema at the injection site), INJECTION SITE PAIN (Tenderness/Pain at the injection site), ASTHENIA (Weakness), PYREXIA (Internal fever) and CHILLS (Chills). At the time of the report, INJECTION SITE ERYTHEMA (Erythema at the injection site), INJECTION SITE PAIN (Tenderness/Pain at the injection site), ASTHENIA (Weakness), PYREXIA (Internal fever) and CHILLS (Chills) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Treatment medications included Tylenol.; 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: 75.0
Sex: F
Vaccine: COVID19
Symptoms: Biopsy, Erythema
Clinical narrative: both arms were having red dots; This spontaneous case was reported by a consumer and describes the occurrence of ERYTHEMA (both arms were having red dots) in a 75-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 039k20A) for COVID-19 vaccination.     The patient's past medical history included Back injury NOS (Broken back). Concurrent medical conditions included Hypertension, Diabetic, Arthritis, Cataract and Drug allergy (Alopurinol). Concomitant products included TRAMADOL, PRAMIPEXOLE, TORSEMIDE, PANTOPRAZOLE, CICLOSPORIN (RESTASIS) and POTASSIUM for an unknown indication.    On 29-Dec-2020 at 10:30 AM, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 30-Dec-2020, the patient experienced ERYTHEMA (both arms were having red dots). At the time of the report, ERYTHEMA (both arms were having red dots) had resolved.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, Biopsy: other (Negative) Negative.     The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       The treatment information was not provided.   Most recent FOLLOW-UP information incorporated above includes: On 01-May-2021: Outcome of the event On 10-Jun-2021: F/U attached
Sex: U
Vaccine: COVID19
Symptoms: Headache
Clinical narrative: This spontaneous case was reported by an other health care professional and describes the occurrence of HEADACHE (Severe 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 first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced HEADACHE (Severe headache). At the time of the report, HEADACHE (Severe headache) 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. Concomitant product use was not provided by the reporter. No treatment medications were reported. Reporter did not allow further contact; 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. Further information has been requested
Age: 80.0
Sex: F
Vaccine: COVID19
Symptoms: Cough, Decreased appetite, Diarrhoea, Ear infection, Fatigue
Clinical narrative: lip blister/sores; itchy arm; swollen lymph nodes; red arm rash; headache; tiredness; fever; not feeling right; feeling cold; diarrhea; scratchy, itchy and tickle in throat; loss of appetite; ear infection on and off; cough; This spontaneous case was reported by a consumer and describes the occurrence of MALAISE (not feeling right) and FEELING COLD (feeling cold) in an 80-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 016M20A and 012L20A) for COVID-19 vaccination.     No medical history was provided by reporter.  Concomitant products included LEVOTHYROXINE SODIUM (SYNTHROID), LOSARTAN, FLECAINIDE, ROPINIROLE HYDROCHLORIDE (REQUIP), FUROSEMIDE (LASIX [FUROSEMIDE]), APIXABAN (ELIQUIS), CETIRIZINE HYDROCHLORIDE (ZYRTEC [CETIRIZINE HYDROCHLORIDE]) and PARACETAMOL (TYLENOL) for an unknown indication.   On 11-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 25-Jan-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to .5 ml. On 16-Feb-2021, the patient experienced MALAISE (not feeling right) and FEELING COLD (feeling cold). On 18-Feb-2021, MALAISE (not feeling right) outcome was unknown and FEELING COLD (feeling cold) had resolved.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 16-Feb-2021, Pyrexia: 100.4 (Inconclusive) fever of 100.4F.    Most recent FOLLOW-UP information incorporated above includes: On 13-Jul-2021: NNI case.
Age: 80.0
Sex: F
Vaccine: COVID19
Symptoms: Feeling cold, Headache, Lip blister, Lymphadenopathy, Malaise
Clinical narrative: lip blister/sores; itchy arm; swollen lymph nodes; red arm rash; headache; tiredness; fever; not feeling right; feeling cold; diarrhea; scratchy, itchy and tickle in throat; loss of appetite; ear infection on and off; cough; This spontaneous case was reported by a consumer and describes the occurrence of MALAISE (not feeling right) and FEELING COLD (feeling cold) in an 80-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 016M20A and 012L20A) for COVID-19 vaccination.     No medical history was provided by reporter.  Concomitant products included LEVOTHYROXINE SODIUM (SYNTHROID), LOSARTAN, FLECAINIDE, ROPINIROLE HYDROCHLORIDE (REQUIP), FUROSEMIDE (LASIX [FUROSEMIDE]), APIXABAN (ELIQUIS), CETIRIZINE HYDROCHLORIDE (ZYRTEC [CETIRIZINE HYDROCHLORIDE]) and PARACETAMOL (TYLENOL) for an unknown indication.   On 11-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 25-Jan-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to .5 ml. On 16-Feb-2021, the patient experienced MALAISE (not feeling right) and FEELING COLD (feeling cold). On 18-Feb-2021, MALAISE (not feeling right) outcome was unknown and FEELING COLD (feeling cold) had resolved.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 16-Feb-2021, Pyrexia: 100.4 (Inconclusive) fever of 100.4F.    Most recent FOLLOW-UP information incorporated above includes: On 13-Jul-2021: NNI case.
Age: 80.0
Sex: F
Vaccine: COVID19
Symptoms: Pyrexia, Rash, Throat irritation, Vaccination site pruritus
Clinical narrative: lip blister/sores; itchy arm; swollen lymph nodes; red arm rash; headache; tiredness; fever; not feeling right; feeling cold; diarrhea; scratchy, itchy and tickle in throat; loss of appetite; ear infection on and off; cough; This spontaneous case was reported by a consumer and describes the occurrence of MALAISE (not feeling right) and FEELING COLD (feeling cold) in an 80-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 016M20A and 012L20A) for COVID-19 vaccination.     No medical history was provided by reporter.  Concomitant products included LEVOTHYROXINE SODIUM (SYNTHROID), LOSARTAN, FLECAINIDE, ROPINIROLE HYDROCHLORIDE (REQUIP), FUROSEMIDE (LASIX [FUROSEMIDE]), APIXABAN (ELIQUIS), CETIRIZINE HYDROCHLORIDE (ZYRTEC [CETIRIZINE HYDROCHLORIDE]) and PARACETAMOL (TYLENOL) for an unknown indication.   On 11-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 25-Jan-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to .5 ml. On 16-Feb-2021, the patient experienced MALAISE (not feeling right) and FEELING COLD (feeling cold). On 18-Feb-2021, MALAISE (not feeling right) outcome was unknown and FEELING COLD (feeling cold) had resolved.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 16-Feb-2021, Pyrexia: 100.4 (Inconclusive) fever of 100.4F.    Most recent FOLLOW-UP information incorporated above includes: On 13-Jul-2021: NNI case.
Age: 23.0
Sex: F
Vaccine: COVID19
Symptoms: Injection site erythema, Injection site pain, Injection site swelling
Clinical narrative: redness at injection site; swelling at injection site; Tenderness at injection site; This spontaneous case was reported by a consumer and describes the occurrence of INJECTION SITE PAIN (Tenderness at injection site), INJECTION SITE ERYTHEMA (redness at injection site) and INJECTION SITE SWELLING (swelling at injection site) in a 23-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 011520A) for COVID-19 vaccination.     Concurrent medical conditions included Asthma. Concomitant products included MONTELUKAST, FLUTICASONE and AZELASTINE for Asthma.    On 07-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 08-Jan-2021, the patient experienced INJECTION SITE PAIN (Tenderness at injection site). On 09-Jan-2021, the patient experienced INJECTION SITE ERYTHEMA (redness at injection site) and INJECTION SITE SWELLING (swelling at injection site). At the time of the report, INJECTION SITE PAIN (Tenderness at injection site), INJECTION SITE ERYTHEMA (redness at injection site) and INJECTION SITE SWELLING (swelling at injection site) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   She stated she didn't take anything for it and take prescribed asthma medications called Montelukast, Fluticasone nasal spray, Azelastine nasal spray, Fluticasone Falmetcrol powder inhaler and a acid controller.; 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: 68.0
Sex: F
Vaccine: COVID19
Symptoms: Rash pruritic
Clinical narrative: rash that is itchy; This spontaneous case was reported by a consumer and describes the occurrence of RASH PRURITIC (rash that is itchy) in a 68-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 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 15-Jan-2021, the patient experienced RASH PRURITIC (rash that is itchy). At the time of the report, RASH PRURITIC (rash that is itchy) had not resolved.            Concomitant product use was not provided by the reporter. Treatment was not provided by the reporter.   Most recent FOLLOW-UP information incorporated above includes: On 18-Jun-2021: Follow up was received on 18-Jun-2021. Second dose was given.; 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: 73.0
Sex: F
Vaccine: COVID19
Symptoms: Vaccination site erythema, Vaccination site induration, Vaccination site pain
Clinical narrative: injection site got red; injection site got hard; injection site got hurt; This spontaneous case was reported by a patient and describes the occurrence of VACCINATION SITE ERYTHEMA (injection site got red), VACCINATION SITE INDURATION (injection site got hard) and VACCINATION SITE PAIN (injection site got hurt) in a 73-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 011J20A) for COVID-19 vaccination.     Concurrent medical conditions included Diabetes and Blood pressure abnormal. Concomitant products included LOSARTAN for Blood pressure abnormal, METFORMIN and GLIPIZIDE for Diabetes.    On 05-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 05-Jan-2021, the patient experienced VACCINATION SITE ERYTHEMA (injection site got red), VACCINATION SITE INDURATION (injection site got hard) and VACCINATION SITE PAIN (injection site got hurt). On 15-Jan-2021, VACCINATION SITE PAIN (injection site got hurt) had resolved. At the time of the report, VACCINATION SITE ERYTHEMA (injection site got red) had not resolved and VACCINATION SITE INDURATION (injection site got hard) was resolving.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.; Sender's Comments: Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded.
Sex: M
Vaccine: COVID19
Symptoms: Dizziness, Pyrexia
Clinical narrative: This spontaneous case reported by a consumer, describes the occurrence of pyrexia (100.8ºC/fever) and dizziness in a male patient, of an unknown age, who received mRNA-1273 (Moderna COVID-19 vaccine) for COVID-19 vaccination. No reported medical history. On Jan 14, 2021, patient received the first dose of mRNA-1273 (Moderna COVID-19 vaccine), unknown route; 1 dosage form. On January 2021, patient experienced pyrexia (100.8ºC/fever) and dizziness. At the time of the report, pyrexia (100.8ºC/fever) and dizziness outcome unknown. The action taken with mRNA-1273 (Moderna COVID-19 vaccine) was unknown.
Sex: F
Vaccine: COVID19
Symptoms: Vaccination site pruritus, Vaccination site warmth
Clinical narrative: injection site warm; injection site itchy; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE PRURITUS (injection site itchy) and VACCINATION SITE WARMTH (injection site warm) in a male patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On 12-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 13-Jan-2021, the patient experienced VACCINATION SITE PRURITUS (injection site itchy) and VACCINATION SITE WARMTH (injection site warm). At the time of the report, VACCINATION SITE PRURITUS (injection site itchy) and VACCINATION SITE WARMTH (injection site warm) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       Concomitant medications details were not reported by the reporter. Treatment details was not reported by the reporter.   This case was linked to MOD-2021-008434 (Patient Link).; Sender's Comments: Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded
Sex: F
Vaccine: COVID19
Symptoms: Chills, Fatigue, Feeling cold, Headache, Nausea
Clinical narrative: Runny nose; Tired and Achy; Can't stay out of bathroom; Developed chills galore; Very cold; Arm was sore; Very tired; Had some Chills; Had a Headache; Nausea; This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (Arm was sore), FEELING COLD (Very cold), RHINORRHOEA (Runny nose), PAIN (Tired and Achy) and FATIGUE (Very tired) in a female patient of an unknown age 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 07-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 07-Jan-2021, the patient experienced PAIN IN EXTREMITY (Arm was sore), FATIGUE (Very tired), CHILLS (Had some Chills), HEADACHE (Had a Headache) and NAUSEA (Nausea). On 09-Jan-2021, the patient experienced FEELING COLD (Very cold) and CHILLS (Developed chills galore). On 15-Jan-2021, the patient experienced PAIN (Tired and Achy) and FATIGUE (Can't stay out of bathroom). On an unknown date, the patient experienced RHINORRHOEA (Runny nose). At the time of the report, PAIN IN EXTREMITY (Arm was sore), FEELING COLD (Very cold), RHINORRHOEA (Runny nose), PAIN (Tired and Achy), FATIGUE (Very tired), CHILLS (Had some Chills), HEADACHE (Had a Headache), NAUSEA (Nausea), CHILLS (Developed chills galore) and FATIGUE (Can't stay out of bathroom) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.; Sender's Comments: Very limited information regarding this events has been provided at this time. Further information has been requested. Company assessed the events to be unlikely related to company product.
Sex: F
Vaccine: COVID19
Symptoms: Pain, Pain in extremity, Rhinorrhoea
Clinical narrative: Runny nose; Tired and Achy; Can't stay out of bathroom; Developed chills galore; Very cold; Arm was sore; Very tired; Had some Chills; Had a Headache; Nausea; This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (Arm was sore), FEELING COLD (Very cold), RHINORRHOEA (Runny nose), PAIN (Tired and Achy) and FATIGUE (Very tired) in a female patient of an unknown age 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 07-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 07-Jan-2021, the patient experienced PAIN IN EXTREMITY (Arm was sore), FATIGUE (Very tired), CHILLS (Had some Chills), HEADACHE (Had a Headache) and NAUSEA (Nausea). On 09-Jan-2021, the patient experienced FEELING COLD (Very cold) and CHILLS (Developed chills galore). On 15-Jan-2021, the patient experienced PAIN (Tired and Achy) and FATIGUE (Can't stay out of bathroom). On an unknown date, the patient experienced RHINORRHOEA (Runny nose). At the time of the report, PAIN IN EXTREMITY (Arm was sore), FEELING COLD (Very cold), RHINORRHOEA (Runny nose), PAIN (Tired and Achy), FATIGUE (Very tired), CHILLS (Had some Chills), HEADACHE (Had a Headache), NAUSEA (Nausea), CHILLS (Developed chills galore) and FATIGUE (Can't stay out of bathroom) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.; Sender's Comments: Very limited information regarding this events has been provided at this time. Further information has been requested. Company assessed the events to be unlikely related to company product.
Age: 50.0
Sex: F
Vaccine: COVID19
Symptoms: Erythema, Pyrexia, Swelling face
Clinical narrative: Face is red; Face is little swollen like she had a bad sunburn; Fever; This spontaneous case was reported by a patient and describes the occurrence of ERYTHEMA (Face is red), SWELLING FACE (Face is little swollen like she had a bad sunburn) and PYREXIA (Fever) in a 50-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 028L20A) for COVID-19 vaccination.     The patient's past medical history included No adverse event (No medical history reported).    On 13-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 13-Jan-2021, the patient experienced PYREXIA (Fever). On 15-Jan-2021, the patient experienced ERYTHEMA (Face is red) and SWELLING FACE (Face is little swollen like she had a bad sunburn). On 14-Jan-2021, PYREXIA (Fever) had resolved. At the time of the report, ERYTHEMA (Face is red) and SWELLING FACE (Face is little swollen like she had a bad sunburn) had not resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No concomitant medications are provided.  No treatment medications are provided.; 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: 83.0
Sex: F
Vaccine: COVID19
Symptoms: Vaccination site pain
Clinical narrative: Soreness; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE PAIN (Soreness) in an 83-year-old female patient 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 first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 14-Jan-2021,  after starting mRNA-1273 (Moderna COVID-19 Vaccine), the patient experienced VACCINATION SITE PAIN (Soreness). At the time of the report, VACCINATION SITE PAIN (Soreness) outcome was unknown. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       Concomitant medication was not reported.  Treatment medication was not reported.   This case was linked to MOD-2021-008232 (Patient Link).   Most recent FOLLOW-UP information incorporated above includes: On 29-Mar-2021: TCR - patient refused further follow up.; 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.
Sex: F
Vaccine: COVID19
Symptoms: Adverse event
Clinical narrative: having a reaction; This spontaneous case was reported by a consumer and describes the occurrence of ADVERSE EVENT (having a reaction) 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 first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced ADVERSE EVENT (having a reaction). At the time of the report, ADVERSE EVENT (having a reaction) had not resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       Concomitant product use was not provided by the reporter. No treatment medication was reported.; Sender's Comments: Very limited information regarding this event has been provided at this time.  Further information has been requested.
Age: 40.0
Sex: F
Vaccine: COVID19
Symptoms: Maternal exposure during pregnancy, Pregnancy test, Scan
Clinical narrative: Vaccine exposure during pregnancy; This spontaneous prospective pregnancy case was reported by a physician and describes the occurrence of MATERNAL EXPOSURE DURING PREGNANCY (Vaccine exposure during pregnancy) in a 40-year-old female patient (gravida 2, para 1) who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 011L20A) for COVID-19 vaccination.     The patient's past medical history included Gestational diabetes from 2017 to 11-Sep-2017 and Delivery (Mother developed gestational diabetes, child was born with hipo) on 11-Sep-2017. Concurrent medical conditions included Pregnancy since 08-Sep-2020. Concomitant products included VITAMINS NOS for an unknown indication.    On 15-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. The patient's last menstrual period was on 01-Sep-2020 and the estimated date of delivery was 02-Jun-2021. On 15-Jan-2021, the patient experienced MATERNAL EXPOSURE DURING PREGNANCY (Vaccine exposure during pregnancy). The patient received mRNA-1273 (Moderna COVID-19 Vaccine) beginning around the  nineteenth week of the pregnancy.  At the time of the report, MATERNAL EXPOSURE DURING PREGNANCY (Vaccine exposure during pregnancy) had resolved.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 22-Sep-2020, Pregnancy test: positive (Positive) Positive. In January 2021, Scan: normal (normal) 20 week anatomy scan normal. On an unknown date, Scan: normal (normal) 16 week anatomy scan: Normal.     For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   No Treatment medications was provided by the reporter.  Estimated date of conception was 8 Sep 2020. Previous pregnancy end date on 11 Sep 2017 with events. mother developed gestational diabetes, child was born with hipoglucemia.; Sender's Comments: Based on the current available information and the temporal association between the product use and the start date of the event a causal relationship cannot be excluded.
Age: 44.0
Sex: F
Vaccine: COVID19
Symptoms: Oral discomfort, Vaccination site pain
Clinical narrative: Inside of her mouth was sore like a burn; Soreness at the injection site; This spontaneous case was reported by a physician assistant and describes the occurrence of VACCINATION SITE PAIN (Soreness at the injection site) and ORAL DISCOMFORT (Inside of her mouth was sore like a burn) in a 44-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     Concurrent medical conditions included Hypothyroidism and Allergy to chemicals (Allergic reaction to a dental numbing injection agent). Concomitant products included LEVOTHYROXINE SODIUM (SYNTHROID) for an unknown indication.    On 13-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) .5 dosage form. On 13-Jan-2021, the patient experienced VACCINATION SITE PAIN (Soreness at the injection site). On 14-Jan-2021, the patient experienced ORAL DISCOMFORT (Inside of her mouth was sore like a burn). At the time of the report, VACCINATION SITE PAIN (Soreness at the injection site) and ORAL DISCOMFORT (Inside of her mouth was sore like a burn) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   Treatment information included magic mouth wash which was prescribed by dentist but  has not started using the prescribed medication yet.
Age: 51.0
Sex: F
Vaccine: COVID19
Symptoms: Fatigue, Vaccination site erythema, Vaccination site induration, Vaccination site pain, Vaccination site pruritus
Clinical narrative: It is hard; Red; Itching; felt tired; Swelling; Hot to touch; little bit of soreness; This spontaneous case was reported by a nurse and describes the occurrence of VACCINATION SITE WARMTH (Hot to touch), VACCINATION SITE PAIN (little bit of soreness), VACCINATION SITE INDURATION (It is hard), VACCINATION SITE ERYTHEMA (Red) and VACCINATION SITE PRURITUS (Itching) in a 51-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 025J20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical history information reported.  Concomitant products included VITAMINS NOS for an unknown indication.    On 05-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 08-Jan-2021, the patient experienced VACCINATION SITE PAIN (little bit of soreness). On 14-Jan-2021, the patient experienced VACCINATION SITE WARMTH (Hot to touch), VACCINATION SITE INDURATION (It is hard), VACCINATION SITE ERYTHEMA (Red), VACCINATION SITE PRURITUS (Itching), FATIGUE (felt tired) and VACCINATION SITE SWELLING (Swelling). On 08-Jan-2021, VACCINATION SITE PAIN (little bit of soreness) had resolved. At the time of the report, VACCINATION SITE WARMTH (Hot to touch), VACCINATION SITE INDURATION (It is hard), VACCINATION SITE ERYTHEMA (Red), VACCINATION SITE PRURITUS (Itching), FATIGUE (felt tired) and VACCINATION SITE SWELLING (Swelling) was resolving.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   No treatment medication details were provided.   Most recent FOLLOW-UP information incorporated above includes: On 28-May-2021: No new information reported; 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: 51.0
Sex: F
Vaccine: COVID19
Symptoms: Vaccination site swelling, Vaccination site warmth
Clinical narrative: It is hard; Red; Itching; felt tired; Swelling; Hot to touch; little bit of soreness; This spontaneous case was reported by a nurse and describes the occurrence of VACCINATION SITE WARMTH (Hot to touch), VACCINATION SITE PAIN (little bit of soreness), VACCINATION SITE INDURATION (It is hard), VACCINATION SITE ERYTHEMA (Red) and VACCINATION SITE PRURITUS (Itching) in a 51-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 025J20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical history information reported.  Concomitant products included VITAMINS NOS for an unknown indication.    On 05-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 08-Jan-2021, the patient experienced VACCINATION SITE PAIN (little bit of soreness). On 14-Jan-2021, the patient experienced VACCINATION SITE WARMTH (Hot to touch), VACCINATION SITE INDURATION (It is hard), VACCINATION SITE ERYTHEMA (Red), VACCINATION SITE PRURITUS (Itching), FATIGUE (felt tired) and VACCINATION SITE SWELLING (Swelling). On 08-Jan-2021, VACCINATION SITE PAIN (little bit of soreness) had resolved. At the time of the report, VACCINATION SITE WARMTH (Hot to touch), VACCINATION SITE INDURATION (It is hard), VACCINATION SITE ERYTHEMA (Red), VACCINATION SITE PRURITUS (Itching), FATIGUE (felt tired) and VACCINATION SITE SWELLING (Swelling) was resolving.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   No treatment medication details were provided.   Most recent FOLLOW-UP information incorporated above includes: On 28-May-2021: No new information reported; Sender's Comments: Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded.
Sex: M
Vaccine: COVID19
Symptoms: Muscle spasms, Myalgia
Clinical narrative: This spontaneous case was reported by a consumer and describes the occurrence of MUSCLE SPASMS (Leg Cramps) and MYALGIA (Body Aches) in a 78-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. The patient's past medical history included No adverse event (no adverse event reported). On 11-Jan-2021, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 12-Jan-2021, the patient experienced MUSCLE SPASMS (Leg Cramps) and MYALGIA (Body Aches). At the time of the report, MUSCLE SPASMS (Leg Cramps) had resolved and MYALGIA (Body Aches) outcome was unknown. Not Provided. The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown. For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments. Treatment medication include potassium capsules . Concomitant product was not provided by the repoerter.; 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: 66.0
Sex: F
Vaccine: COVID19
Symptoms: Pain in extremity, Vaccination site erythema, Vaccination site mass, Vaccination site pain, Vaccination site pruritus
Clinical narrative: Warm to touch; Red and warm to touch; Injection site started to itch; Felt tender; Area along the muscle were the vaccine was administered has a bump; Very severe arm pain; This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (Very severe arm pain), VACCINATION SITE MASS (Area along the muscle were the vaccine was administered has a bump), VACCINATION SITE WARMTH (Warm to touch), VACCINATION SITE PRURITUS (Injection site started to itch) and VACCINATION SITE PAIN (Felt tender) in a 66-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 039K20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     Concurrent medical conditions included Renal disease (Kidney Disease).  Concomitant products included RAMIPRIL for Renal disease.   On 05-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 05-Jan-2021, the patient experienced PAIN IN EXTREMITY (Very severe arm pain). On 09-Jan-2021, the patient experienced VACCINATION SITE MASS (Area along the muscle were the vaccine was administered has a bump) and VACCINATION SITE PAIN (Felt tender). On 10-Jan-2021, the patient experienced VACCINATION SITE PRURITUS (Injection site started to itch). On 13-Jan-2021, the patient experienced VACCINATION SITE WARMTH (Warm to touch) and VACCINATION SITE ERYTHEMA (Red and warm to touch). On 09-Jan-2021, PAIN IN EXTREMITY (Very severe arm pain) had resolved. At the time of the report, VACCINATION SITE MASS (Area along the muscle were the vaccine was administered has a bump) and VACCINATION SITE PAIN (Felt tender) had resolved and VACCINATION SITE WARMTH (Warm to touch), VACCINATION SITE PRURITUS (Injection site started to itch) and VACCINATION SITE ERYTHEMA (Red and warm to touch) outcome was unknown.       The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.    Treatment information was not provided.; 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.