chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 80.0
Sex: M
Vaccine: COVID19
Symptoms: Product dose omission issue, Sleep disorder
Clinical narrative: Experiencing wake up and go to sleep and , I don't sleep good, wake up I fall asleep; doesn't wish to get second dose; This spontaneous case was reported by a consumer and describes the occurrence of SLEEP DISORDER (Experiencing wake up and go to sleep and , I don't sleep good, wake up I fall asleep) and PRODUCT DOSE OMISSION ISSUE (doesn't wish to get second dose) in an 80-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 04SA21A) for COVID-19 vaccination.     The patient's past medical history included COVID-19 in October 2020. Concurrent medical conditions included Prostate tenderness, Atrial fibrillation, Hypertension and COPD.    On 18-Mar-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 SLEEP DISORDER (Experiencing wake up and go to sleep and , I don't sleep good, wake up I fall asleep) and PRODUCT DOSE OMISSION ISSUE (doesn't wish to get second dose). At the time of the report, SLEEP DISORDER (Experiencing wake up and go to sleep and , I don't sleep good, wake up I fall asleep) outcome was unknown and PRODUCT DOSE OMISSION ISSUE (doesn't wish to get second dose) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       Concomitant medications included prostate medicines, blood thinners, high blood pressure medicines.  Treatment information not provided.; Sender's Comments: This case concerns an 80-year-old male patient who received the first dose of the mRNA-1273 and experienced sleep disorder and doesn't wish to get second dose (product dose omission).  Sleep disorder show temporal association with product administration and causality cannot be excluded.  Product dose omission is assessed as not applicable.
Age: 63.0
Sex: F
Vaccine: COVID19
Symptoms: Oropharyngeal pain, Vaccination site pain
Clinical narrative: Sore throat; Muscle pain around the site of injection; This spontaneous case was reported by a consumer and describes the occurrence of OROPHARYNGEAL PAIN (Sore throat) and VACCINATION SITE PAIN (Muscle pain around the site of injection) in a 63-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 028A21A) for COVID-19 vaccination.     No Medical History information was reported.    On 25-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 26-Mar-2021, the patient experienced OROPHARYNGEAL PAIN (Sore throat) and VACCINATION SITE PAIN (Muscle pain around the site of injection). At the time of the report, OROPHARYNGEAL PAIN (Sore throat) and VACCINATION SITE PAIN (Muscle pain around the site of injection) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No Concomitant product use was reported.  No treatment information was provided.; Sender's Comments: Based on the current available information which includes a temporal association between the use of mRNA-1273 and the start date of the reported events, a causal relationship with the event cannot be excluded. Vaccination site pain is consistent with the known safety profile of the vaccine.
Age: 78.0
Sex: M
Vaccine: COVID19
Symptoms: Body temperature, Chills, Fatigue, Lethargy, Myalgia
Clinical narrative: very fatigued; muscle aches and pains; Lethargy; Body aches; shaking chills; ran a temperature (fever 102.4); This spontaneous case was reported by a consumer and describes the occurrence of LETHARGY (Lethargy), PAIN (Body aches), CHILLS (shaking chills), PYREXIA (ran a temperature (fever 102.4)) and FATIGUE (very fatigued) in a 78-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 022M20A and 003821A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     The patient's past medical history included COVID-19 in November 2020 and Atrial fibrillation. Concomitant products included APIXABAN (ELIQUIS) and METOPROLOL for Atrial fibrillation, ROSUVASTATIN CALCIUM (CRESTOR) for Cholesterol high, ASCORBIC ACID (VITAMINS C), VITAMIN D3, CYANOCOBALAMIN (VITAMIN B-12) and PARACETAMOL (TYLENOL EXTRA STRENGTH) for an unknown indication.   On 15-Feb-2021 at 10:00 AM, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 26-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 15-Feb-2021, the patient experienced LETHARGY (Lethargy), PAIN (Body aches), CHILLS (shaking chills) and PYREXIA (ran a temperature (fever 102.4)). On 16-Feb-2021, the patient experienced FATIGUE (very fatigued) and MYALGIA (muscle aches and pains). On 16-Feb-2021, LETHARGY (Lethargy) had resolved. On 25-Feb-2021, PAIN (Body aches) had resolved. On 28-Feb-2021, CHILLS (shaking chills) had resolved. On 09-Mar-2021, FATIGUE (very fatigued) and MYALGIA (muscle aches and pains) had resolved. At the time of the report, PYREXIA (ran a temperature (fever 102.4)) had resolved.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, Body temperature increased: 102.4 degree Celsius.     The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) and mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       This case was linked to MOD-2021-040288 (Patient Link).   Most recent FOLLOW-UP information incorporated above includes: On 06-May-2021: reporter Email, Demographic were updated
Age: 78.0
Sex: M
Vaccine: COVID19
Symptoms: Pain, Pyrexia
Clinical narrative: very fatigued; muscle aches and pains; Lethargy; Body aches; shaking chills; ran a temperature (fever 102.4); This spontaneous case was reported by a consumer and describes the occurrence of LETHARGY (Lethargy), PAIN (Body aches), CHILLS (shaking chills), PYREXIA (ran a temperature (fever 102.4)) and FATIGUE (very fatigued) in a 78-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 022M20A and 003821A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     The patient's past medical history included COVID-19 in November 2020 and Atrial fibrillation. Concomitant products included APIXABAN (ELIQUIS) and METOPROLOL for Atrial fibrillation, ROSUVASTATIN CALCIUM (CRESTOR) for Cholesterol high, ASCORBIC ACID (VITAMINS C), VITAMIN D3, CYANOCOBALAMIN (VITAMIN B-12) and PARACETAMOL (TYLENOL EXTRA STRENGTH) for an unknown indication.   On 15-Feb-2021 at 10:00 AM, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 26-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 15-Feb-2021, the patient experienced LETHARGY (Lethargy), PAIN (Body aches), CHILLS (shaking chills) and PYREXIA (ran a temperature (fever 102.4)). On 16-Feb-2021, the patient experienced FATIGUE (very fatigued) and MYALGIA (muscle aches and pains). On 16-Feb-2021, LETHARGY (Lethargy) had resolved. On 25-Feb-2021, PAIN (Body aches) had resolved. On 28-Feb-2021, CHILLS (shaking chills) had resolved. On 09-Mar-2021, FATIGUE (very fatigued) and MYALGIA (muscle aches and pains) had resolved. At the time of the report, PYREXIA (ran a temperature (fever 102.4)) had resolved.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, Body temperature increased: 102.4 degree Celsius.     The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) and mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       This case was linked to MOD-2021-040288 (Patient Link).   Most recent FOLLOW-UP information incorporated above includes: On 06-May-2021: reporter Email, Demographic were updated
Age: 24.0
Sex: M
Vaccine: COVID19
Symptoms: Pyrexia, Somnolence
Clinical narrative: Spend most of that day sleeping; Had fever; This spontaneous case was reported by a consumer and describes the occurrence of SOMNOLENCE (Spend most of that day sleeping) and PYREXIA (Had fever) in a 24-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 immunisation.     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, 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 SOMNOLENCE (Spend most of that day sleeping) and PYREXIA (Had fever). At the time of the report, SOMNOLENCE (Spend most of that day sleeping) and PYREXIA (Had fever) had resolved.            Treatment information was not provided.; Sender's Comments: Based on the current available information which includes a temporal association between the use of mRNA-1273 and the start date of the reported events, a causal relationship with the event cannot be excluded. Fever is consistent with the known safety profile of the vaccine
Age: 38.0
Sex: F
Vaccine: COVID19
Symptoms: Discomfort, Muscle spasms, Pain in extremity
Clinical narrative: Feeling uncomfortable; Cramps; Arm is aching; This spontaneous case was reported by a consumer and describes the occurrence of DISCOMFORT (Feeling uncomfortable), MUSCLE SPASMS (Cramps) and PAIN IN EXTREMITY (Arm is aching) in a 38-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No medical history was reported.  Concurrent medical conditions included Down's syndrome.   On 25-Mar-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 25-Mar-2021, the patient experienced PAIN IN EXTREMITY (Arm is aching). On 26-Mar-2021, the patient experienced DISCOMFORT (Feeling uncomfortable) and MUSCLE SPASMS (Cramps). At the time of the report, DISCOMFORT (Feeling uncomfortable), MUSCLE SPASMS (Cramps) and PAIN IN EXTREMITY (Arm is aching) was resolving.            No concomitant medications were reported. Treatment information was not provided. Action taken with mRNA-1273 in response to the event was not applicable.   Most recent FOLLOW-UP information incorporated above includes: On 11-May-2021: Reporter denied further follow-up and stated that patient was fine now.
Age: 40.0
Sex: F
Vaccine: COVID19
Symptoms: Furuncle
Clinical narrative: Skin abscess: boil (Right) leg; This spontaneous case was reported by a pharmacist and describes the occurrence of FURUNCLE (Skin abscess: boil (Right) leg) in a 40-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) (Intramuscular) 1 dosage form. On 21-Jan-2021, the patient experienced FURUNCLE (Skin abscess: boil (Right) leg). The patient was treated with CEFALEXIN (KEFLEX [CEFALEXIN]) at an unspecified dose and frequency. On 06-Mar-2021, FURUNCLE (Skin abscess: boil (Right) leg) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   No concomitant medication was provided.    This case was linked to MOD-2021-036790 (Patient Link).; Sender's Comments: Bacteria typically cause a furuncle,.  Hence, based on biological implausibility, a causal association with  administration of mRNA-1273 is assessed as unlikely.
Sex: U
Vaccine: COVID19
Symptoms: Vaccination complication
Clinical narrative: Had reaction to first shot; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION COMPLICATION (Had reaction to first shot) in a  patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced VACCINATION COMPLICATION (Had reaction to first shot). At the time of the report, VACCINATION COMPLICATION (Had reaction to first shot) 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 assessment. No concomitant medications were reported. Treatment information was not provided.   This case was linked to MOD-2021-060125 (Patient Link).
Age: 72.0
Sex: F
Vaccine: COVID19
Symptoms: Fatigue, Rash, Rash papular, Vaccination site erythema, Vaccination site swelling
Clinical narrative: puffiness; raised areas; rash; Very tired; Pink blotch; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE SWELLING (puffiness), RASH PAPULAR (raised areas), RASH (rash), FATIGUE (Very tired) and VACCINATION SITE ERYTHEMA (Pink blotch) in a 71-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 010A21A) for COVID-19 vaccination.     No Medical History information was reported.    On 24-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 27-Feb-2021, the patient experienced VACCINATION SITE ERYTHEMA (Pink blotch). On 25-Mar-2021, the patient experienced VACCINATION SITE SWELLING (puffiness), RASH PAPULAR (raised areas), RASH (rash) and FATIGUE (Very tired). The patient was treated with DIPHENHYDRAMINE HYDROCHLORIDE (BENADRYL [DIPHENHYDRAMINE HYDROCHLORIDE]) at a dose of 1 dosage form. On 26-Mar-2021, FATIGUE (Very tired) had resolved. At the time of the report, VACCINATION SITE SWELLING (puffiness), RASH PAPULAR (raised areas), RASH (rash) and VACCINATION SITE ERYTHEMA (Pink blotch) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       This case was linked to US-MODERNATX, INC.-MOD-2021-060118 (E2B Linked Report).; Sender's Comments: Based on the current available information which includes a temporal association between the use of mRNA-1273 and the start date of the reported events, a causal relationship with the event cannot be excluded. Vaccination site pain , vaccination site swelling, vaccination site erythema, fatigue and rash are consistent with the known safety profile of the vaccine. US-MODERNATX, INC.-MOD-2021-060118:Case for first dose
Age: 90.0
Sex: F
Vaccine: COVID19
Symptoms: Pain in extremity
Clinical narrative: Pain in extremity; This spontaneous case was reported by a nurse (subsequently medically confirmed) and describes the occurrence of PAIN IN EXTREMITY (Pain in extremity) in a 90-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 029A21A) for COVID-19 vaccination.     The patient's past medical history included Monoclonal antibody immunoconjugate therapy since 28-Dec-2020.    On 10-Mar-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 extremity). At the time of the report, PAIN IN EXTREMITY (Pain in extremity) 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 medications were not provided Treatment information was not provided; Sender's Comments: Based on the current available information which includes a temporal association between the use of mRNA-1273 and the start date of the reported events, a causal relationship with the event cannot be excluded
Age: 71.0
Sex: F
Vaccine: COVID19
Symptoms: Vaccination site erythema, Vaccination site rash
Clinical narrative: Pink blotch; vaccination site erythema; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE RASH (Pink blotch) and VACCINATION SITE ERYTHEMA (vaccination site erythema) in a 71-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 010A21A) for COVID-19 vaccination.     No Medical History information was reported.    On 24-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 27-Feb-2021, the patient experienced VACCINATION SITE RASH (Pink blotch) and VACCINATION SITE ERYTHEMA (vaccination site erythema). The patient was treated with DIPHENHYDRAMINE HYDROCHLORIDE (BENADRYL [DIPHENHYDRAMINE HYDROCHLORIDE]) at an unspecified dose and frequency. At the time of the report, VACCINATION SITE RASH (Pink blotch) and VACCINATION SITE ERYTHEMA (vaccination site erythema) outcome was unknown. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       This case was linked to MOD-2021-060111 (Patient Link).; Sender's Comments: Based on the current available information which includes a temporal association between the use of mRNA-1273 and the start date of the reported events, a causal relationship with the event cannot be excluded. The reported events are consistent with the known safety profile of the vaccine.
Age: 42.0
Sex: F
Vaccine: COVID19
Symptoms: Dizziness, Fatigue, Feeling abnormal, Malaise, Vomiting
Clinical narrative: Felt "yicky"; Dizzy; Felt similar to when she was pregnant; Threw up; Fatigue; This spontaneous case was reported by a consumer (subsequently medically confirmed) and describes the occurrence of FEELING ABNORMAL (Felt "yicky"), DIZZINESS (Dizzy), MALAISE (Felt similar to when she was pregnant), VOMITING (Threw up) and FATIGUE (Fatigue) in a 42-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 025A21A) for COVID-19 vaccination.     No Medical History information was reported.    On 02-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 02-Mar-2021, the patient experienced FEELING ABNORMAL (Felt "yicky"), DIZZINESS (Dizzy), MALAISE (Felt similar to when she was pregnant), VOMITING (Threw up) and FATIGUE (Fatigue). At the time of the report, FEELING ABNORMAL (Felt "yicky"), DIZZINESS (Dizzy), MALAISE (Felt similar to when she was pregnant), VOMITING (Threw up) and FATIGUE (Fatigue) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Concomitant medications were not reported. Treatment information were not provided.; Sender's Comments: Based on the current available information which includes a temporal association between the use of mRNA-1273 and the start date of the reported events, a causal relationship with the event cannot be excluded. Fatigue and vomiting are consistent with the known safety profile of the vaccine.
Age: 70.0
Sex: F
Vaccine: COVID19
Symptoms: Ageusia, Fatigue, Headache, Pain in extremity
Clinical narrative: Loss of taste; Headache; Feeling tired; Sore arm; This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (Sore arm), HEADACHE (Headache), FATIGUE (Feeling tired) and AGEUSIA (Loss of taste) in a 70-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 027A21A) for COVID-19 vaccination.     The patient's past medical history included No adverse event.    On 01-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 01-Mar-2021, the patient experienced PAIN IN EXTREMITY (Sore arm), HEADACHE (Headache) and FATIGUE (Feeling tired). On 18-Mar-2021, the patient experienced AGEUSIA (Loss of taste). The patient was treated with PARACETAMOL (TYLENOL) at an unspecified dose and frequency. At the time of the report, PAIN IN EXTREMITY (Sore arm), HEADACHE (Headache), FATIGUE (Feeling tired) and AGEUSIA (Loss of taste) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.; Sender's Comments: Based on the current available information which includes a temporal association between the use of mRNA-1273 and the start date of the reported events, a causal relationship with the event cannot be excluded. Fever and headache are consistent with the known safety profile of the vaccine.
Age: 61.0
Sex: M
Vaccine: COVID19
Symptoms: Malaise
Clinical narrative: Feeling Worse; This spontaneous case was reported by an other and describes the occurrence of MALAISE (Feeling Worse) in a 61-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 medical history reported).    On 12-Mar-2021, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) at an unspecified dose. In March 2021, the patient experienced MALAISE (Feeling Worse). At the time of the report, MALAISE (Feeling Worse) was resolving.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown Route) was unknown.       Reporter did not allow further contact
Age: 78.0
Sex: F
Vaccine: COVID19
Symptoms: Vaccination site erythema, Vaccination site swelling
Clinical narrative: This spontaneous case reported by a consumer, describes the occurrence of vaccination site swelling (swelling where the needle went in) and vaccination site erythema (red circle where the needle went in) in a 78-year-old female patient who received mRNA-1273 (Moderna COVID-19 vaccine, batch/lot# 026A21A) for COVID-19 immunization. No medical history reported. On Mar 25, 2021, patient received the first dose of mRNA-1273 (Moderna COVID-19 vaccine), intramuscular; 1 dosage form. On Mar 25, 2021, patient experienced vaccination site swelling (swelling where the needle went in) and vaccination site erythema (red circle where the needle went in). At the time of the report, vaccination site swelling (swelling where the needle went in) and vaccination site erythema (red circle where the needle went in): unresolved. The action taken with mRNA-1273 (Moderna COVID-19 vaccine), intramuscular: unknown. No concomitant medication or treatment information reported.
Sex: M
Vaccine: COVID19
Symptoms: Pain in extremity
Clinical narrative: sore left arm; This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (sore left arm) 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 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) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient experienced PAIN IN EXTREMITY (sore left arm). At the time of the report, PAIN IN EXTREMITY (sore left arm) outcome was unknown.            No concomitant medications were reported. No treatment details were reported.; Sender's Comments: Although a temporal association cannot be established, based on the information provided, a causal association cannot be excluded.
Age: 74.0
Sex: M
Vaccine: COVID19
Symptoms: Asthenia, Myalgia, Neck pain
Clinical narrative: Weakness; Neck pain; Muscle pain; This spontaneous case was reported by a consumer and describes the occurrence of ASTHENIA (Weakness ), NECK PAIN (Neck pain) and MYALGIA (Muscle pain) in a 74-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 003A21A) for COVID-19 vaccination.     The patient's past medical history included COVID-19 in August 2020, Taste loss in August 2020 and Smell loss in August 2020.    On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 10-Mar-2021, the patient experienced ASTHENIA (Weakness ), NECK PAIN (Neck pain) and MYALGIA (Muscle pain). At the time of the report, ASTHENIA (Weakness ), NECK PAIN (Neck pain) and MYALGIA (Muscle pain) outcome was unknown. Unknown      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Treatment information was not provided. Concomitant medication was not provided.; Sender's Comments: Based on the current available information which includes a temporal association between the use of mRNA-1273 and the start date of the reported events, a causal relationship with the event cannot be excluded. Myalgia is consistent with the known safety profile of the vaccine.
Age: 67.0
Sex: F
Vaccine: COVID19
Symptoms: Bone pain, Injection site pain, Injection site rash, Insomnia, Pain
Clinical narrative: Achy all over; Soreness at the injection site; Rash at the injection site; Every bone in her body hurt; Unable to sleep; This spontaneous case was reported by a consumer and describes the occurrence of BONE PAIN (Every bone in her body hurt), INSOMNIA (Unable to sleep), PAIN (Achy all over), INJECTION SITE PAIN (Soreness at the injection site) and INJECTION SITE RASH (Rash at the injection site) in a 67-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On 28-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 28-Mar-2021, the patient experienced BONE PAIN (Every bone in her body hurt), INSOMNIA (Unable to sleep), INJECTION SITE PAIN (Soreness at the injection site) and INJECTION SITE RASH (Rash at the injection site). On 29-Mar-2021, the patient experienced PAIN (Achy all over). At the time of the report, BONE PAIN (Every bone in her body hurt), INSOMNIA (Unable to sleep), PAIN (Achy all over), INJECTION SITE PAIN (Soreness at the injection site) and INJECTION SITE RASH (Rash at the injection site) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No concomitant medication was reported.  Tylenol was taken as treatment medication.   This case was linked to MOD-2021-060108 (Patient Link).   Most recent FOLLOW-UP information incorporated above includes: On 19-Jul-2021: Followup received: Treatment medication and events outcome added
Age: 80.0
Sex: F
Vaccine: COVID19
Symptoms: Illness, Nausea, Vaccination site erythema, Vaccination site induration, Vomiting
Clinical narrative: Stay sick all that night; Red bump below site of injection; Red bump below site of injection; Quizzes that day; At night vomiting; This spontaneous case was reported by a consumer (subsequently medically confirmed) and describes the occurrence of ILLNESS (Stay sick all that night), VACCINATION SITE INDURATION (Red bump below site of injection), VACCINATION SITE ERYTHEMA (Red bump below site of injection), NAUSEA (Quizzes that day) and VOMITING (At night vomiting) in an 80-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 023M20A) for COVID-19 vaccination.     Concurrent medical conditions included Penicillin allergy, COPD and Seasonal allergy (Allergy in summer time.). Concomitant products included IPRATROPIUM BROMIDE and BUDESONIDE, FORMOTEROL FUMARATE (SYMBICORT) for COPD, METOPROLOL, VITAMIN D NOS and ASCORBIC ACID, CALCIUM, MINERALS NOS, RETINOL, TOCOPHERYL ACETATE, VITAMIN B NOS, VITAMINS NOS, ZINC (CENTRUM SILVER [ASCORBIC ACID;CALCIUM;MINERALS NOS;RETINOL;TOCOPHERYL ACETATE;VITAMIN B NOS;VITAMINS NOS;ZINC]) for an unknown indication.    On 08-Mar-2021 at 9:30 AM, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 08-Mar-2021, the patient experienced NAUSEA (Quizzes that day). 08-Mar-2021, the patient experienced VOMITING (At night vomiting). On 09-Mar-2021, the patient experienced ILLNESS (Stay sick all that night), VACCINATION SITE INDURATION (Red bump below site of injection) and VACCINATION SITE ERYTHEMA (Red bump below site of injection). At the time of the report, ILLNESS (Stay sick all that night), VACCINATION SITE INDURATION (Red bump below site of injection), VACCINATION SITE ERYTHEMA (Red bump below site of injection), NAUSEA (Quizzes that day) and VOMITING (At night vomiting) outcome was unknown.            Patient stated HCP  had sent medicine to stop vomiting and being sick. Action taken with mRNA-1273 in response to the event was not applicable.   This case was linked to MOD21-050946 (Patient Link).; Sender's Comments: Based on the current available information which includes a temporal association between the use of mRNA-1273 and the start date of the reported events, a causal relationship with the event cannot be excluded. Vaccination site nodule, vaccination site erythema, nausea and vomiting are consistent with the known safety profile of the vaccine.
Sex: M
Vaccine: COVID19
Symptoms: Back pain, Pain, Pain in extremity
Clinical narrative: This spontaneous case reported by a consumer, describes the occurrence of pain, pain in extremity (flare-up and pain on bottom of right foot) and back pain (pain in back) in a male patient, of an unknown age, who received mRNA-1273 (Moderna COVID-19 vaccine) for COVID-19 immunization. The patient's past medical history included gout. On Mar 2, 2021, patient received the second dose of mRNA-1273 (Moderna COVID-19  vaccine), intramuscular; 1 dosage form. On Mar 4, 2021, patient experienced pain, pain in extremity (flare-up and pain on bottom of right foot) and back pain (pain in back). The patient treated with Tylenol (paracetamol), at an unspecified dose and frequency. At the time of the report, pain, pain in extremity (flare-up and pain on bottom of right foot) and back pain (pain in back) outcome: unknown. No concomitant medications provided. Action taken with mRNA-1273 in response to the event: not applicable.
Age: 51.0
Sex: F
Vaccine: COVID19
Symptoms: Rash
Clinical narrative: Rash; This spontaneous case was reported by a consumer and describes the occurrence of RASH (Rash) in a 51-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 004M20A and 016M20A) for COVID-19 vaccination.     The patient's past medical history included No adverse event (No medical history reported).   On 29-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 26-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 28-Feb-2021, the patient experienced RASH (Rash). At the time of the report, RASH (Rash) outcome was unknown.  Treatment details included Benadryl and Singulair.; Sender's Comments: Based on the current available information which includes a temporal association between the use of mRNA-1273 and the start date of the reported events, a causal relationship with the event cannot be excluded. Rash is consistent with the known safety profile of the vaccine.
Sex: F
Vaccine: COVID19
Symptoms: Arthralgia, Chills, Diarrhoea, Headache, Nausea
Clinical narrative: Diarrhea; Chills; Slight headache; Nausea; Joint aches; This spontaneous case was reported by a consumer and describes the occurrence of DIARRHOEA (Diarrhea), CHILLS (Chills), HEADACHE (Slight headache), NAUSEA (Nausea) and ARTHRALGIA (Joint aches) in a 120-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 015M20A) for COVID-19 vaccination.     No Medical History information was reported.    On 05-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 19-Mar-2021, the patient experienced DIARRHOEA (Diarrhea), CHILLS (Chills), HEADACHE (Slight headache), NAUSEA (Nausea) and ARTHRALGIA (Joint aches). The patient was treated with IBUPROFEN at an unspecified dose and frequency. At the time of the report, DIARRHOEA (Diarrhea), CHILLS (Chills), HEADACHE (Slight headache), NAUSEA (Nausea) and ARTHRALGIA (Joint aches) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No relevant concomitant medications were reported.  Company comment: Based on the current available information which includes a temporal association between the use of mRNA-1273 and the start date of the reported events, a causal relationship with the event cannot be excluded. Headache, nausea arthralgia and chills are consistent with the known safety profile of the vaccine.   Most recent FOLLOW-UP information incorporated above includes: On 01-Jul-2021: Event outcome updated; Sender's Comments: Based on the current available information which includes a temporal association between the use of mRNA-1273 and the start date of the reported events, a causal relationship with the event cannot be excluded. Headache, nausea arthralgia and chills are consistent with the known safety profile of the vaccine.
Age: 61.0
Sex: F
Vaccine: COVID19
Symptoms: Dizziness, Feeling abnormal, Nervousness, Vaccination site induration, Vaccination site nodule
Clinical narrative: Didn't feel great; Little shaky; Side effects made her nervous; Lightheaded; Warm at injection site; Knot at injection site; Hard at injection site; Rash at injection site 5 inches wide; Swollen at injection site; Arm soreness for 2 to 3 days; This spontaneous case was reported by a patient and describes the occurrence of VACCINATION SITE PAIN (Arm soreness for 2 to 3 days), FEELING ABNORMAL (Didn't feel great), NERVOUSNESS (Little shaky), NERVOUSNESS (Side effects made her nervous) and DIZZINESS (Lightheaded) in a 61-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 030a21a) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.    On 17-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 17-Mar-2021, the patient experienced VACCINATION SITE PAIN (Arm soreness for 2 to 3 days). On 26-Mar-2021, the patient experienced FEELING ABNORMAL (Didn't feel great), NERVOUSNESS (Little shaky), NERVOUSNESS (Side effects made her nervous), DIZZINESS (Lightheaded), VACCINATION SITE WARMTH (Warm at injection site), VACCINATION SITE NODULE (Knot at injection site), VACCINATION SITE INDURATION (Hard at injection site), VACCINATION SITE RASH (Rash at injection site 5 inches wide) and VACCINATION SITE SWELLING (Swollen at injection site). At the time of the report, VACCINATION SITE PAIN (Arm soreness for 2 to 3 days), FEELING ABNORMAL (Didn't feel great), NERVOUSNESS (Little shaky), NERVOUSNESS (Side effects made her nervous), DIZZINESS (Lightheaded), VACCINATION SITE WARMTH (Warm at injection site), VACCINATION SITE NODULE (Knot at injection site), VACCINATION SITE INDURATION (Hard at injection site), VACCINATION SITE RASH (Rash at injection site 5 inches wide) and VACCINATION SITE SWELLING (Swollen at injection site) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No concomitant medication details was reported. No treatment medication details was reported.   Most recent FOLLOW-UP information incorporated above includes: On 03-Aug-2021: Follow-up information received on 03-AUG-2021 added Email ID of reporter.; Sender's Comments: Based on the current available information which includes a temporal association between the use of mRNA-1273 and the start date of the reported events, a causal relationship with the event cannot be excluded. Vaccination site induration, injection site rash, and injection site swelling are consistent with the known safety profile of the vaccine.
Age: 61.0
Sex: F
Vaccine: COVID19
Symptoms: Vaccination site pain, Vaccination site rash, Vaccination site swelling, Vaccination site warmth
Clinical narrative: Didn't feel great; Little shaky; Side effects made her nervous; Lightheaded; Warm at injection site; Knot at injection site; Hard at injection site; Rash at injection site 5 inches wide; Swollen at injection site; Arm soreness for 2 to 3 days; This spontaneous case was reported by a patient and describes the occurrence of VACCINATION SITE PAIN (Arm soreness for 2 to 3 days), FEELING ABNORMAL (Didn't feel great), NERVOUSNESS (Little shaky), NERVOUSNESS (Side effects made her nervous) and DIZZINESS (Lightheaded) in a 61-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 030a21a) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.    On 17-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 17-Mar-2021, the patient experienced VACCINATION SITE PAIN (Arm soreness for 2 to 3 days). On 26-Mar-2021, the patient experienced FEELING ABNORMAL (Didn't feel great), NERVOUSNESS (Little shaky), NERVOUSNESS (Side effects made her nervous), DIZZINESS (Lightheaded), VACCINATION SITE WARMTH (Warm at injection site), VACCINATION SITE NODULE (Knot at injection site), VACCINATION SITE INDURATION (Hard at injection site), VACCINATION SITE RASH (Rash at injection site 5 inches wide) and VACCINATION SITE SWELLING (Swollen at injection site). At the time of the report, VACCINATION SITE PAIN (Arm soreness for 2 to 3 days), FEELING ABNORMAL (Didn't feel great), NERVOUSNESS (Little shaky), NERVOUSNESS (Side effects made her nervous), DIZZINESS (Lightheaded), VACCINATION SITE WARMTH (Warm at injection site), VACCINATION SITE NODULE (Knot at injection site), VACCINATION SITE INDURATION (Hard at injection site), VACCINATION SITE RASH (Rash at injection site 5 inches wide) and VACCINATION SITE SWELLING (Swollen at injection site) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No concomitant medication details was reported. No treatment medication details was reported.   Most recent FOLLOW-UP information incorporated above includes: On 03-Aug-2021: Follow-up information received on 03-AUG-2021 added Email ID of reporter.; Sender's Comments: Based on the current available information which includes a temporal association between the use of mRNA-1273 and the start date of the reported events, a causal relationship with the event cannot be excluded. Vaccination site induration, injection site rash, and injection site swelling are consistent with the known safety profile of the vaccine.
Age: 73.0
Sex: F
Vaccine: COVID19
Symptoms: Feeling abnormal, Feeling cold, Limb discomfort, Musculoskeletal stiffness, Myalgia
Clinical narrative: Body is sore right; started stiffening up; whole body froze; Couldn't sit up; couldn't move arms and legs; woke up vioent7ly shaking; This spontaneous case was reported by a consumer and describes the occurrence of TREMOR (woke up violently shaking), MUSCULOSKELETAL STIFFNESS (started stiffening up), FEELING COLD (whole body froze), FEELING ABNORMAL (Couldn't sit up) and LIMB DISCOMFORT (couldn't move arms and legs) in a 73-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 016MZ(or2)0A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     Concurrent medical conditions included Allergic reaction to drug (Sulfa drugs).    On 24-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 24-Mar-2021, the patient experienced TREMOR (woke up violently shaking). On 25-Mar-2021, the patient experienced MUSCULOSKELETAL STIFFNESS (started stiffening up), FEELING COLD (whole body froze), FEELING ABNORMAL (Couldn't sit up) and LIMB DISCOMFORT (couldn't move arms and legs). On 26-Mar-2021, the patient experienced MYALGIA (Body is sore right). On 24-Mar-2021, TREMOR (woke up violently shaking) had resolved. At the time of the report, MUSCULOSKELETAL STIFFNESS (started stiffening up), FEELING COLD (whole body froze), FEELING ABNORMAL (Couldn't sit up), LIMB DISCOMFORT (couldn't move arms and legs) and MYALGIA (Body is sore right) outcome was unknown.        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.; Sender's Comments: Based on the current available information which includes a temporal association between the use of mRNA-1273 and the start date of the reported events, a causal relationship with the event cannot be excluded. Myalgia is consistent with the known safety profile of the vaccine.
Age: 73.0
Sex: F
Vaccine: COVID19
Symptoms: Tremor
Clinical narrative: Body is sore right; started stiffening up; whole body froze; Couldn't sit up; couldn't move arms and legs; woke up vioent7ly shaking; This spontaneous case was reported by a consumer and describes the occurrence of TREMOR (woke up violently shaking), MUSCULOSKELETAL STIFFNESS (started stiffening up), FEELING COLD (whole body froze), FEELING ABNORMAL (Couldn't sit up) and LIMB DISCOMFORT (couldn't move arms and legs) in a 73-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 016MZ(or2)0A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     Concurrent medical conditions included Allergic reaction to drug (Sulfa drugs).    On 24-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 24-Mar-2021, the patient experienced TREMOR (woke up violently shaking). On 25-Mar-2021, the patient experienced MUSCULOSKELETAL STIFFNESS (started stiffening up), FEELING COLD (whole body froze), FEELING ABNORMAL (Couldn't sit up) and LIMB DISCOMFORT (couldn't move arms and legs). On 26-Mar-2021, the patient experienced MYALGIA (Body is sore right). On 24-Mar-2021, TREMOR (woke up violently shaking) had resolved. At the time of the report, MUSCULOSKELETAL STIFFNESS (started stiffening up), FEELING COLD (whole body froze), FEELING ABNORMAL (Couldn't sit up), LIMB DISCOMFORT (couldn't move arms and legs) and MYALGIA (Body is sore right) outcome was unknown.        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.; Sender's Comments: Based on the current available information which includes a temporal association between the use of mRNA-1273 and the start date of the reported events, a causal relationship with the event cannot be excluded. Myalgia is consistent with the known safety profile of the vaccine.
Age: 66.0
Sex: F
Vaccine: COVID19
Symptoms: Decreased appetite, Fatigue, Headache, Pain, Rash
Clinical narrative: achiness; lost of appetite; tired; Headache; rash; This spontaneous case was reported by a pharmacist and describes the occurrence of PAIN (achiness), DECREASED APPETITE (lost of appetite), FATIGUE (tired), HEADACHE (Headache) and RASH (rash) in a 66-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On an unknown date, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced PAIN (achiness), DECREASED APPETITE (lost of appetite), FATIGUE (tired), HEADACHE (Headache) and RASH (rash). At the time of the report, PAIN (achiness), DECREASED APPETITE (lost of appetite), FATIGUE (tired), HEADACHE (Headache) and RASH (rash) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.; Sender's Comments: Based on the current available information which includes a temporal association between the use of mRNA-1273 and the start date of the reported events, a causal relationship with the event cannot be excluded. Rash, headache, fatigue are consistent with the known safety profile of the vaccine.
Sex: M
Vaccine: COVID19
Symptoms: Erythema, Vaccination site erythema, Vaccination site pruritus
Clinical narrative: redness few inches in size; itching arm; red arm; arm red; This spontaneous case was reported by a consumer and describes the occurrence of ERYTHEMA (redness few inches in size), VACCINATION SITE PRURITUS (itching arm), VACCINATION SITE ERYTHEMA (arm red) and VACCINATION SITE ERYTHEMA (red arm) in a male patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     The patient's past medical history included No adverse event.    On 18-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 18-Mar-2021, the patient experienced VACCINATION SITE ERYTHEMA (arm red). On 25-Mar-2021, the patient experienced VACCINATION SITE PRURITUS (itching arm) and VACCINATION SITE ERYTHEMA (red arm). On an unknown date, the patient experienced ERYTHEMA (redness few inches in size). On 22-Mar-2021, VACCINATION SITE ERYTHEMA (arm red) had resolved. At the time of the report, ERYTHEMA (redness few inches in size), VACCINATION SITE PRURITUS (itching arm) and VACCINATION SITE ERYTHEMA (red arm) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       Concomitant medication was not provided Treatment information was not provided   Reporter did not allow further contact; Sender's Comments: Based on the current available information which includes a temporal association between the use of mRNA-1273 and the start date of the reported events, a causal relationship with the event cannot be excluded. The reported events are consistent with the known safety profile of the vaccine.
Age: 73.0
Sex: F
Vaccine: COVID19
Symptoms: Chronic obstructive pulmonary disease, Sinus disorder
Clinical narrative: Was in ER yesterday for her COPD; A little sinus problem; This spontaneous case was reported by a consumer (subsequently medically confirmed) and describes the occurrence of CHRONIC OBSTRUCTIVE PULMONARY DISEASE (Was in ER yesterday for her COPD) and SINUS DISORDER (A little sinus problem) in a 73-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 014M20A) for COVID-19 vaccination.     Concurrent medical conditions included COPD and Heart disease, unspecified.   On 26-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 26-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 26-Feb-2021, the patient experienced SINUS DISORDER (A little sinus problem). On 25-Mar-2021, the patient experienced CHRONIC OBSTRUCTIVE PULMONARY DISEASE (Was in ER yesterday for her COPD). At the time of the report, CHRONIC OBSTRUCTIVE PULMONARY DISEASE (Was in ER yesterday for her COPD) and SINUS DISORDER (A little sinus problem) outcome was unknown.            Laboratory details were not provided.  No concurrent medication was reported. No treatment information was provided by the reporter. .   Most recent FOLLOW-UP information incorporated above includes: On 11-Jun-2021: Allergy reported; Reporter's Comments: Based on the current available information and temporal association between the use of the product and the onset date of the reported events of sinus disorder and COPD, a causal relationship cannot be excluded. Patient's underlying COPD may have been contributory.