chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 67.0
Sex: F
Vaccine: COVID19
Symptoms: Burning sensation, Myalgia, Pain in extremity, Tenderness, Vaccination site rash
Clinical narrative: Burning sensation in arm; sore muscle in shoulder; Vaccination site soreness; Tenderness under arm; red rash on arm; Vaccination site swelling; This spontaneous case was reported by a consumer and describes the occurrence of BURNING SENSATION (Burning sensation in arm), VACCINATION SITE RASH (red rash on arm), MYALGIA (sore muscle in shoulder), VACCINATION SITE SWELLING (Vaccination site swelling) and PAIN IN EXTREMITY (Vaccination site soreness) in a 67-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.  Concurrent medical conditions included Lyme disease and Penicillin allergy. Concomitant products included VITAMIN D NOS, CALCIUM CITRATE (CITRACAL [CALCIUM CITRATE]) and VITAMIN B COMPLEX for an unknown indication.   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 MYALGIA (sore muscle in shoulder). On 24-Jan-2021, the patient experienced BURNING SENSATION (Burning sensation in arm) and VACCINATION SITE RASH (red rash on arm). On an unknown date, the patient experienced VACCINATION SITE SWELLING (Vaccination site swelling), PAIN IN EXTREMITY (Vaccination site soreness) and TENDERNESS (Tenderness under arm). The patient was treated with DIPHENHYDRAMINE HYDROCHLORIDE (BENADRYL [DIPHENHYDRAMINE HYDROCHLORIDE]) for Rash, at a dose of 1 dosage form. At the time of the report, BURNING SENSATION (Burning sensation in arm), VACCINATION SITE RASH (red rash on arm), MYALGIA (sore muscle in shoulder), VACCINATION SITE SWELLING (Vaccination site swelling), PAIN IN EXTREMITY (Vaccination site soreness) and TENDERNESS (Tenderness under arm) outcome was unknown.   The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.    Treatment details also included icepacks.  Most recent FOLLOW-UP information incorporated above includes: On 25-Jan-2021: Patient demography updated, patient history updated, concomitant medications were updated, events were updated. On 19-Jun-2021: No new information
Age: 67.0
Sex: F
Vaccine: COVID19
Symptoms: Vaccination site swelling
Clinical narrative: Burning sensation in arm; sore muscle in shoulder; Vaccination site soreness; Tenderness under arm; red rash on arm; Vaccination site swelling; This spontaneous case was reported by a consumer and describes the occurrence of BURNING SENSATION (Burning sensation in arm), VACCINATION SITE RASH (red rash on arm), MYALGIA (sore muscle in shoulder), VACCINATION SITE SWELLING (Vaccination site swelling) and PAIN IN EXTREMITY (Vaccination site soreness) in a 67-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.  Concurrent medical conditions included Lyme disease and Penicillin allergy. Concomitant products included VITAMIN D NOS, CALCIUM CITRATE (CITRACAL [CALCIUM CITRATE]) and VITAMIN B COMPLEX for an unknown indication.   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 MYALGIA (sore muscle in shoulder). On 24-Jan-2021, the patient experienced BURNING SENSATION (Burning sensation in arm) and VACCINATION SITE RASH (red rash on arm). On an unknown date, the patient experienced VACCINATION SITE SWELLING (Vaccination site swelling), PAIN IN EXTREMITY (Vaccination site soreness) and TENDERNESS (Tenderness under arm). The patient was treated with DIPHENHYDRAMINE HYDROCHLORIDE (BENADRYL [DIPHENHYDRAMINE HYDROCHLORIDE]) for Rash, at a dose of 1 dosage form. At the time of the report, BURNING SENSATION (Burning sensation in arm), VACCINATION SITE RASH (red rash on arm), MYALGIA (sore muscle in shoulder), VACCINATION SITE SWELLING (Vaccination site swelling), PAIN IN EXTREMITY (Vaccination site soreness) and TENDERNESS (Tenderness under arm) outcome was unknown.   The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.    Treatment details also included icepacks.  Most recent FOLLOW-UP information incorporated above includes: On 25-Jan-2021: Patient demography updated, patient history updated, concomitant medications were updated, events were updated. On 19-Jun-2021: No new information
Age: 89.0
Sex: F
Vaccine: COVID19
Symptoms: Erythema, Pruritus, Skin discolouration
Clinical narrative: Little white circle with red spot in the middle the sizer of a nickel; Itch a lot; Red spot the size of a silver dollar; This spontaneous case was reported by a consumer and describes the occurrence of SKIN DISCOLOURATION (Little white circle with red spot in the middle the sizer of a nickel), ERYTHEMA (Red spot the size of a silver dollar) and PRURITUS (Itch a lot) in an 89-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On 15-Jan-2021, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 18-Jan-2021, the patient experienced ERYTHEMA (Red spot the size of a silver dollar). On an unknown date, the patient experienced SKIN DISCOLOURATION (Little white circle with red spot in the middle the sizer of a nickel) and PRURITUS (Itch a lot). At the time of the report, SKIN DISCOLOURATION (Little white circle with red spot in the middle the sizer of a nickel), ERYTHEMA (Red spot the size of a silver dollar) and PRURITUS (Itch a lot) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Concomitant product use was not provided by the reporter.  Treatment information was not provided.
Sex: F
Vaccine: COVID19
Symptoms: Hypersensitivity
Clinical narrative: Allergic Reaction; This spontaneous case was reported by a consumer and describes the occurrence of HYPERSENSITIVITY (Allergic 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 12-Jan-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 HYPERSENSITIVITY (Allergic Reaction). At the time of the report, HYPERSENSITIVITY (Allergic Reaction) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       The relevant concomitant medications use were not reported Treatment details were not reported by the reporter.
Age: 78.0
Sex: F
Vaccine: COVID19
Symptoms: Vaccination site erythema
Clinical narrative: Big, round red spot at the site of injection and its still there after 3 weeks; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE ERYTHEMA (Big, round red spot at the site of injection and its still there after 3 weeks) in a 78-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 025120-2A) for COVID-19 vaccination.     No Medical History information was reported.    On 14-Jan-2021, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 14-Jan-2021, the patient experienced VACCINATION SITE ERYTHEMA (Big, round red spot at the site of injection and its still there after 3 weeks). At the time of the report, VACCINATION SITE ERYTHEMA (Big, round red spot at the site of injection and its still there after 3 weeks) had not resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Concomitant product use was not provided by the reporter.  No treatment information was provided.
Age: 62.0
Sex: F
Vaccine: COVID19
Symptoms: Vaccination site erythema, Vaccination site pruritus, Vaccination site swelling
Clinical narrative: arm turned red and itchy below the injection site; arm turned red and itchy below the injection site; Injection site Swelling; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE PRURITUS (arm turned red and itchy below the injection site), VACCINATION SITE ERYTHEMA (arm turned red and itchy below the injection site) and VACCINATION SITE SWELLING (Injection site Swelling) in a 62-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 026L20A and 028L20A) for COVID-19 vaccination.     The patient's past medical history included Ulcerative colitis (Ulcerative colitis flare.) from 18-Dec-2020 to 20-Dec-2020 and Ulcerative colitis (Ulcerative colitis ; mild.) in 1974. Concomitant products included LACTOBACILLUS ACIDOPHILUS (LACTOBACILLUS) for Probiotic therapy.   On 14-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 11-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 21-Jan-2021, the patient experienced VACCINATION SITE PRURITUS (arm turned red and itchy below the injection site), VACCINATION SITE ERYTHEMA (arm turned red and itchy below the injection site) and VACCINATION SITE SWELLING (Injection site Swelling). At the time of the report, VACCINATION SITE PRURITUS (arm turned red and itchy below the injection site), VACCINATION SITE ERYTHEMA (arm turned red and itchy below the injection site) and VACCINATION SITE SWELLING (Injection site Swelling) had resolved.            No Treatment information has been provided. Action take n with mRNA-1273 (Moderna COVID-19 Vaccine) was not applicable.   Most recent FOLLOW-UP information incorporated above includes: On 15-Apr-2021: Follow up received included reporter information, patient medical history, concomitant medication, doses information and event start date.
Sex: F
Vaccine: COVID19
Symptoms: Vaccination site erythema, Vaccination site swelling
Clinical narrative: redness; swollen-ness; Based on the current case data, this case has been classified as invalid. This spontaneous case was reported by a patient and describes the occurrence of VACCINATION SITE ERYTHEMA (redness) and VACCINATION SITE SWELLING (swollen-ness) in a female 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 (No reported medical history).   On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On an unknown date, the patient experienced VACCINATION SITE ERYTHEMA (redness) and VACCINATION SITE SWELLING (swollen-ness). At the time of the report, VACCINATION SITE ERYTHEMA (redness) and VACCINATION SITE SWELLING (swollen-ness) outcome was unknown. Not Provided          No relevant concomitant medications were reported. No treatment  information was provided Action taken with mRNA-1273 in response to the event was not applicable.
Age: 68.0
Sex: F
Vaccine: COVID19
Symptoms: Rash, Vaccination site erythema, Vaccination site pain, Vaccination site swelling
Clinical narrative: a pinkish red rash, 4-5 little rashes in different parts of the body; swelling at the injection site; very little pain at the injection site; a red spot around the injection site; This spontaneous case was reported by a consumer and describes the occurrence of RASH (a pinkish red rash, 4-5 little rashes in different parts of the body), VACCINATION SITE SWELLING (swelling at the injection site), VACCINATION SITE PAIN (very little pain at the injection site) and VACCINATION SITE ERYTHEMA (a red spot around the injection site) in a 68-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 011L20A) for COVID-19 vaccination.     No Medical History information was reported.    On 13-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced RASH (a pinkish red rash, 4-5 little rashes in different parts of the body), VACCINATION SITE SWELLING (swelling at the injection site), VACCINATION SITE PAIN (very little pain at the injection site) and VACCINATION SITE ERYTHEMA (a red spot around the injection site). At the time of the report, RASH (a pinkish red rash, 4-5 little rashes in different parts of the body) and VACCINATION SITE ERYTHEMA (a red spot around the injection site) had not resolved and VACCINATION SITE SWELLING (swelling at the injection site) and VACCINATION SITE PAIN (very little pain at the injection site) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No treatment information provided Treatment Cortisone cream and Benadryl   Reporter did not allow further contact
Age: 76.0
Sex: M
Vaccine: COVID19
Symptoms: Rash erythematous, Rash pruritic, Vaccination site swelling
Clinical narrative: Round red rash, very very scratchy itchy 2inches below injection site; Round red rash, very very scratchy itchy 2inches below injection site; puffy red welt an inch across/Sort of swell; This spontaneous case was reported by a consumer and describes the occurrence of RASH ERYTHEMATOUS (Round red rash, very very scratchy itchy 2inches below injection site), RASH PRURITIC (Round red rash, very very scratchy itchy 2inches below injection site) and VACCINATION SITE SWELLING (puffy red welt an inch across/Sort of swell) in a 76-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 013L20A) for COVID-19 vaccination.     Concurrent medical conditions included Hypertension. Concomitant products included LISINOPRIL and METOPROLOL for Hypertension, TAMSULOSIN HYDROCHLORIDE (TAMULOSIN), FINASTERIDE and VITAMINS NOS for an unknown indication.   On 16-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On an unknown date, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 26-Jan-2021, the patient experienced RASH ERYTHEMATOUS (Round red rash, very very scratchy itchy 2inches below injection site), RASH PRURITIC (Round red rash, very very scratchy itchy 2inches below injection site) and VACCINATION SITE SWELLING (puffy red welt an inch across/Sort of swell). At the time of the report, RASH ERYTHEMATOUS (Round red rash, very very scratchy itchy 2inches below injection site) and RASH PRURITIC (Round red rash, very very scratchy itchy 2inches below injection site) had resolved and VACCINATION SITE SWELLING (puffy red welt an inch across/Sort of swell) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) and mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       Treatment provided with anti- itch   Most recent FOLLOW-UP information incorporated above includes: On 15-Apr-2021: Outcome of the event rash was updated from unknown to recovered. Patient had not visited the physician regarding the AR. Adverse reaction onset date from 25 Jan 2021 to 26 Jan 2021.Patient received second vaccine dose and has experienced any rash.
Age: 81.0
Sex: M
Vaccine: COVID19
Symptoms: Abdominal distension, Abdominal pain upper, Diarrhoea
Clinical narrative: Pain in stomach; Bloating; Diarrhea; This spontaneous case was reported by a consumer and describes the occurrence of ABDOMINAL PAIN UPPER (Pain in stomach), ABDOMINAL DISTENSION (Bloating) and DIARRHOEA (Diarrhea) in an 81-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 013L20A) for COVID-19 vaccination.     Concurrent medical conditions included Diarrhea.    On 18-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 19-Jan-2021, the patient experienced ABDOMINAL PAIN UPPER (Pain in stomach), ABDOMINAL DISTENSION (Bloating) and DIARRHOEA (Diarrhea). At the time of the report, ABDOMINAL PAIN UPPER (Pain in stomach), ABDOMINAL DISTENSION (Bloating) and DIARRHOEA (Diarrhea) outcome was unknown. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No relevant concomitant medications were reported.  Treatment included nifedipine and loperamide hydrochloride (Imodium).
Age: 42.0
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, Chills, Dizziness, Fatigue, Pyrexia
Clinical narrative: dizzy; chills; fever; fatigue; Tested positive for Covid-19; This spontaneous case was reported by a consumer and describes the occurrence of COVID-19 (Tested positive for Covid-19), DIZZINESS (dizzy), CHILLS (chills), PYREXIA (fever) and FATIGUE (fatigue) in a 42-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 39K20A) for COVID-19 vaccination.     Concomitant products included ACETYLSALICYLIC ACID (BABY ASPIRIN), ASCORBIC ACID (VITAMIN C ACID), VITAMIN D [VITAMIN D NOS] and CYANOCOBALAMIN (VITAMIN B12 AMINO) for an unknown indication.    On 15-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 16-Jan-2021, the patient experienced COVID-19 (Tested positive for Covid-19), CHILLS (chills), PYREXIA (fever) and FATIGUE (fatigue). On 17-Jan-2021, the patient experienced DIZZINESS (dizzy). At the time of the report, COVID-19 (Tested positive for Covid-19), DIZZINESS (dizzy), CHILLS (chills), PYREXIA (fever) and FATIGUE (fatigue) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Treatment Motrin 400 mg Saturday when diagnosed by rapid test used twice an inhaler Mucinex Lorazepam because the tightness in the chest was causing a lot of anxiety   Reporter did not allow further contact
Age: 26.0
Sex: F
Vaccine: COVID19
Symptoms: Exposure during pregnancy
Clinical narrative: Pregnancy and vaccinated; This spontaneous prospective pregnancy case was reported by a physician (subsequently medically confirmed) and describes the occurrence of EXPOSURE DURING PREGNANCY (Pregnancy and vaccinated) in a 26-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     The patient's past medical history included Asthma since an unknown date. Concomitant products included VITAMINS NOS.    On 11-Feb-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 an unknown date and the estimated date of delivery was 05-Oct-2021. On an unknown date, the patient experienced EXPOSURE DURING PREGNANCY (Pregnancy and vaccinated). At the time of the report, EXPOSURE DURING PREGNANCY (Pregnancy and vaccinated) 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.   No treatment information provided
Sex: F
Vaccine: COVID19
Symptoms: Headache, Vaccination site erythema
Clinical narrative: arm where shot was given had a read area going down arm; slight headache / come and go headache; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE ERYTHEMA (arm where shot was given had a read area going down arm) and HEADACHE (slight headache / come and go headache) 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 15-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 16-Jan-2021, the patient experienced VACCINATION SITE ERYTHEMA (arm where shot was given had a read area going down arm) and HEADACHE (slight headache / come and go headache). At the time of the report, VACCINATION SITE ERYTHEMA (arm where shot was given had a read area going down arm) was resolving and HEADACHE (slight headache / come and go headache) outcome was unknown. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No concomitant medications were provided No treatment information provided    Most recent FOLLOW-UP information incorporated above includes: On 19-Apr-2021: No new information was provided.
Sex: U
Vaccine: COVID19
Symptoms: Hypoaesthesia, Paraesthesia
Clinical narrative: numbness in left of foot and hand; tingling in left side of foot and hand; This spontaneous case was reported by a consumer and describes the occurrence of HYPOAESTHESIA (numbness in left of foot and hand) and PARAESTHESIA (tingling in left side of foot and hand) in a  patient of an unknown age and gender 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 providfed).    On an unknown date, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced HYPOAESTHESIA (numbness in left of foot and hand) and PARAESTHESIA (tingling in left side of foot and hand). At the time of the report, HYPOAESTHESIA (numbness in left of foot and hand) and PARAESTHESIA (tingling in left side of foot and hand) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No concomitant medications were provided No treatment information provided   Reporter did not allow further contact
Age: 47.0
Sex: F
Vaccine: COVID19
Symptoms: Anosmia, Burning sensation, Rash, Vaccination site mass
Clinical narrative: No sense of smell; Hot burning rash on left arm; rash throughout arm an into wrist/hot burning rash on left arm; Lump at injection site; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE MASS (Lump at injection site), ANOSMIA (No sense of smell) and BURNING SENSATION (Hot burning rash on left arm) in a 47-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 028L20A) for COVID-19 vaccination.     Concurrent medical conditions included Seasonal allergy and Drug allergy (Bactrim). Concomitant products included MONTELUKAST SODIUM (SINGULAIR) from 02-Jan-2010 to an unknown date and CETIRIZINE HYDROCHLORIDE (ZYRTEC [CETIRIZINE HYDROCHLORIDE]) for Seasonal allergy.    On 20-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 20-Jan-2021, the patient experienced VACCINATION SITE MASS (Lump at injection site). On 21-Jan-2021, the patient experienced ANOSMIA (No sense of smell) and BURNING SENSATION (Hot burning rash on left arm). The patient was treated with PARACETAMOL (TYLENOL) at an unspecified dose and frequency; IBUPROFEN (ADVIL [IBUPROFEN]) at an unspecified dose and frequency and DIPHENHYDRAMINE HYDROCHLORIDE (BENADRYL [DIPHENHYDRAMINE HYDROCHLORIDE]) at an unspecified dose and frequency. On 23-Jan-2021, VACCINATION SITE MASS (Lump at injection site) had resolved. On 08-Feb-2021, BURNING SENSATION (Hot burning rash on left arm) had resolved. At the time of the report, ANOSMIA (No sense of smell) had not resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Most recent FOLLOW-UP information incorporated above includes: On 21-Apr-2021: Event details updated, added detailsof second dose of moderna vaccine, added medical history and also added race and ethnic group of patient
Age: 54.0
Sex: M
Vaccine: COVID19
Symptoms: COVID-19, Feeling abnormal, Product dose omission issue, SARS-CoV-2 test
Clinical narrative: patiend missed second shot which is scheduled on 01st Feb; Tested positive to COVID-19; Feeling bad and showing symptoms/tested positive for COVID-19; This spontaneous case was reported by a consumer (subsequently medically confirmed) and describes the occurrence of FEELING ABNORMAL (Feeling bad and showing symptoms/tested positive for COVID-19), COVID-19 (Tested positive to COVID-19) and PRODUCT DOSE OMISSION ISSUE (patiend missed second shot which is scheduled on 01st Feb) in a 54-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     Concurrent medical conditions included Sarcoidosis (Chronic respiratory conditions) since 2001.    On 04-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 19-Jan-2021, the patient experienced FEELING ABNORMAL (Feeling bad and showing symptoms/tested positive for COVID-19). On 21-Jan-2021, the patient experienced COVID-19 (Tested positive to COVID-19). On 01-Feb-2021, the patient experienced PRODUCT DOSE OMISSION ISSUE (patiend missed second shot which is scheduled on 01st Feb). The patient was treated with BAMLANIVIMAB (intravenous) 21-Jan-2021 for COVID-19, at an unspecified dose and frequency. On 01-Feb-2021, PRODUCT DOSE OMISSION ISSUE (patiend missed second shot which is scheduled on 01st Feb) had resolved. At the time of the report, FEELING ABNORMAL (Feeling bad and showing symptoms/tested positive for COVID-19) and COVID-19 (Tested positive to COVID-19) was resolving.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 21-Jan-2021, SARS-CoV-2 test: positive (Positive) tested positive for COVID-19.     mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosing remained unchanged.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   On 21-Jan-2021, the patient tested positive for COVID-19 through a RAPID test. and the doctor prescribed a monoclonal antibody infusion, Bamlanivimab IV infusion, on the same day. He was scheduled to have his second Moderna vaccine on 01-Feb-2021. He was feeling about 80-85% back to normal. And symptoms for COVID-19 includes Fever, chills, shortness of breath muscle aches, loss of taste and loss of smell.   Most recent FOLLOW-UP information incorporated above includes: On 15-Apr-2021: No new information On 24-Jul-2021: Significant FU- Lab data, medical history, treatment medication and Symptoms for COVID-19 and second dose information was updated
Age: 74.0
Sex: F
Vaccine: COVID19
Symptoms: Vaccination site erythema, Vaccination site pruritus, Vaccination site urticaria
Clinical narrative: itching; hives in the shot area; 4 inches redness around injection site; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE PRURITUS (itching), VACCINATION SITE URTICARIA (hives in the shot area) and VACCINATION SITE ERYTHEMA (4 inches redness around injection site) in a 74-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 041L20A) for COVID-19 vaccination.     The patient's past medical history included No adverse event.    On 15-Jan-2021, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 22-Jan-2021, the patient experienced VACCINATION SITE PRURITUS (itching), VACCINATION SITE URTICARIA (hives in the shot area) and VACCINATION SITE ERYTHEMA (4 inches redness around injection site). At the time of the report, VACCINATION SITE PRURITUS (itching), VACCINATION SITE URTICARIA (hives in the shot area) and VACCINATION SITE ERYTHEMA (4 inches redness around injection site) 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 medications were provided.  No treatment information provided
Sex: F
Vaccine: COVID19
Symptoms: Maternal exposure during pregnancy, Pregnancy test
Clinical narrative: Got vaccine while pregnant; This spontaneous prospective pregnancy case was reported by a consumer and describes the occurrence of MATERNAL EXPOSURE DURING PREGNANCY (Got vaccine while pregnant) in a 33-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No medical history report provided by the reporter.  The patient's past medical history included Pregnancy (Live, full-term birth) on 2016. Concomitant products included MINERALS NOS, VITAMINS NOS (PRENATAL VITAMINS [MINERALS NOS;VITAMINS NOS]) for an unknown indication.    On 04-Feb-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 10-Jan-2021 and the estimated date of delivery was 16-Oct-2021. On 04-Feb-2021, the patient experienced MATERNAL EXPOSURE DURING PREGNANCY (Got vaccine while pregnant). The patient received mRNA-1273 (Moderna COVID-19 Vaccine) beginning around the  third week of the pregnancy.  On 04-Feb-2021, MATERNAL EXPOSURE DURING PREGNANCY (Got vaccine while pregnant) had resolved.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 11-Feb-2021, Pregnancy test: positive (Positive) Positive.     The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No concomitant medications were provided No treatment information provided
Sex: F
Vaccine: COVID19
Symptoms: Arthralgia, Nausea, Pain
Clinical narrative: Pain in her joints; Pain in ribs, back, and legs; nauseous; A spontaneous report was received from a consumer concerning a 77 year-old, female patient, who received Moderna's COVID-19 vaccine (mRNA-1273) in the Emergency Use Program and felt sore, pain in joints and nauseous.  The patient's medical history, was not reported. Concomitant medications were not reported.  On 28-JAN-2021, prior to the onset of the events, the patient received their first of two planned doses of mRNA-1273 (unknown Batch number), intramuscularly write if given) in the left deltoid for prophylaxis of COVID-19 infection.    On 28-JAN-2021, after to receiving mRNA-1273, the patient felt sore. And on the next day 29-JAN-2021, she felt pain in joints and nauseous. Additionally, pain continued to get worse in her ribs, back, and legs. Treatment for the event included Tylenol and aspercreme.  Action taken with mRNA-1273 in response to the events was not reported.   The outcome for the events, pain in joints, ribs, back, and legs and feeling nauseus were not resolved at the time of reporting of this report.; Reporter's Comments: Based on the current available information and temporal association between the use of the product and the onset date of the events, a causal relationship cannot be excluded.
Age: 80.0
Sex: M
Vaccine: COVID19
Symptoms: Cough, Feeling abnormal, Feeling drunk, Oropharyngeal pain, Pulmonary mass
Clinical narrative: Cough; sore throat; Felt like I had a hangover; Felt terrible/I felt like was going to die; Nodule in lung; This spontaneous case was reported by a consumer and describes the occurrence of COUGH (Cough), OROPHARYNGEAL PAIN (sore throat), FEELING DRUNK (Felt like I had a hangover), FEELING ABNORMAL (Felt terrible/I felt like was going to die) and PULMONARY MASS (Nodule in lung) in an 80-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 013L20A) for COVID-19 vaccination.     The patient's past medical history included Stent placement (3 stents). Concurrent medical conditions included Blood pressure high, Cholesterol and Heart valve replacement NOS (Valve replacement issue in May/June). Concomitant products included METOPROLOL for Blood pressure high, ATORVASTATIN CALCIUM ANHYDROUS for Cholesterol.    On 22-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 24-Jan-2021, the patient experienced COUGH (Cough), OROPHARYNGEAL PAIN (sore throat), FEELING DRUNK (Felt like I had a hangover), FEELING ABNORMAL (Felt terrible/I felt like was going to die) and PULMONARY MASS (Nodule in lung). The patient was treated with CLOPIDOGREL BISULFATE (PLAVIX) for Surgery, at an unspecified dose and frequency. At the time of the report, COUGH (Cough), OROPHARYNGEAL PAIN (sore throat), FEELING DRUNK (Felt like I had a hangover) and FEELING ABNORMAL (Felt terrible/I felt like was going to die) had resolved and PULMONARY MASS (Nodule in lung) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Treatment included Lozenges for sore throat. Other than nodule in lungs, patient's other symptoms lasted an hour or two. Patient didn't have any side effects for the second dose. Patient has taken the second dose on 25-FEB-2021 in left non-dominant arm, lot no- 001A21A   This case was linked to MOD-2021-023991 (Patient Link).   Most recent FOLLOW-UP information incorporated above includes: On 12-Jul-2021: Follow up information was received. Reporter's address was added. Patient's relevant medical history ,concomitant medication, treatment and an additional event were updated.
Age: 42.0
Sex: F
Vaccine: COVID19
Symptoms: Maternal exposure during pregnancy, Pregnancy test, Vaccination site pain
Clinical narrative: 5 weeks pregnant; A bit of pain at injection site; This spontaneous prospective pregnancy case was reported by a consumer and describes the occurrence of MATERNAL EXPOSURE DURING PREGNANCY (5 weeks pregnant) and VACCINATION SITE PAIN (A bit of pain at injection site) in a 42-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 016M20A) for COVID-19 vaccination.     No Medical History information was reported.    On 06-Feb-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 05-Jan-2021 and the estimated date of delivery was 12-Oct-2021. On 06-Feb-2021, the patient experienced VACCINATION SITE PAIN (A bit of pain at injection site). On 11-Feb-2021, the patient experienced MATERNAL EXPOSURE DURING PREGNANCY (5 weeks pregnant). The patient received mRNA-1273 (Moderna COVID-19 Vaccine) beginning around the  fourth week of the pregnancy.  On 11-Feb-2021, MATERNAL EXPOSURE DURING PREGNANCY (5 weeks pregnant) had resolved. At the time of the report, VACCINATION SITE PAIN (A bit of pain at injection site) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 11-Feb-1021, Pregnancy test: positive (Positive) positive.     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.   Also reported patient doesn't know due date because they still have to study her pregnancy because maybe they are twins. No concomitant medications were provided No treatment information provided Gestational diabetes was observed with first baby  in August 2006 and gestational diabetes and born prematurely because they were twins. Born when 32 weeks.
Age: 50.0
Sex: F
Vaccine: COVID19
Symptoms: Arthralgia, Dyspnoea, Headache, SARS-CoV-2 test, Vaccination site pain
Clinical narrative: Joint pain; Shortness of breathe; Headache; Pain at injection site; This spontaneous case was reported by a consumer and describes the occurrence of DYSPNOEA (Shortness of breathe), HEADACHE (Headache), VACCINATION SITE PAIN (Pain at injection site) and ARTHRALGIA (Joint pain) in a 50-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 027L20A) for COVID-19 vaccination.     The patient's past medical history included COVID-19 in June 2020.    On 09-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 09-Jan-2021, the patient experienced DYSPNOEA (Shortness of breathe), HEADACHE (Headache) and VACCINATION SITE PAIN (Pain at injection site). On 09-Jun-2021, the patient experienced ARTHRALGIA (Joint pain). The patient was treated with PARACETAMOL (TYLENOL) on 09-Jan-2021 for Adverse event following immunisation, at a dose of UNK dosage form. At the time of the report, DYSPNOEA (Shortness of breathe), HEADACHE (Headache), VACCINATION SITE PAIN (Pain at injection site) and ARTHRALGIA (Joint pain) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): In June 2020, SARS-CoV-2 test: unknown (Positive) unknown.     The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   Concomitant medications were not provided by reporter.   Most recent FOLLOW-UP information incorporated above includes: On 09-Jun-2021: Event added joint pain. Also patient reported she never experienced the adverse events reported in initial source document and the only event she experienced was joint pain which may or may not be due to vaccine according to her.; 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: 42.0
Sex: F
Vaccine: COVID19
Symptoms: Abnormal loss of weight, Decreased appetite, Vomiting
Clinical narrative: Vomiting; Not able to eat; Lost 18 pounds; A spontaneous report was received from a Nurse  concerning a 42-year-old, Female patient who received Moderna's COVID-19 vaccine (mRNA-1273) and experienced vomiting, Not able to eat, and Lost 18 pounds.  The patient's medical history was not provided. No relevant concomitant medications were reported.    On 30 Dec 2020, the patient received their first of two planned doses of mRNA-1273 (Lot number:  026L20A ) intramuscularly, in left arm for prophylaxis of COVID-19 infection.    On 30 Dec 2020, two hours after taking the vaccine, the patient started vomiting, she was not able to eat and lost 18 pounds. The patient was treated with Zofran (Ondansetron) in order to be able to keep fluids down, but almost had to be hospitalized for these symptoms. Patient is schedule to get the second dose tomorrow and wanted to know if it would be safe.  Action taken with mRNA-1273 in response to the events was not reported.     The outcome of the events vomiting, Not able to eat, and Lost 18 pounds were recovered on 11-JAN-2021.; Reporter'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: 74.0
Sex: M
Vaccine: COVID19
Symptoms: Bronchitis, Pneumonia, Pyrexia, SARS-CoV-2 test, SARS-CoV-2 test positive
Clinical narrative: Pneumonia; tested positive to covid; Bronchitis; Low grade fever; A spontaneous report was received from a 74 year old male patient, who received Moderna's COVID-19 vaccine (mRNA-1273) was tested positive for Covid and experienced pneumonia, had a little bit of phlegm, bronchitis, and low grade fever.  Patient's medical history was not provided. No relevant concomitant medications were reported.   On 12 JAN 2021, prior to the onset of the events, the patient received their first of two planned doses of mRNA-1273 (Lot number: not provided) for prophylaxis of COVID-19 infection.   On 16 JAN 2021, the patient tested positive for Covid. He also experienced pneumonia, bronchitis, low grade fever and had a little bit of phlegm. He took antibiotics and was quarantined for 14 days. He went back to his doctor for a second round of amoxicillin after 14 days.  On an unknown date, the patient was tested negative for Covid.  On 10 FEB 2021, he went back to receive second dose of Moderna vaccine and was told to wait for 90 days, although he said he was tested negative from Covid.  Action taken with mRNA-1273 in response to the events was not provided.  The event, tested positive for Covid was considered resolved and outcome of the events pneumonia, had a little bit of phlegm, bronchitis, and low grade fever was not provided.; Reporter's Comments: Based on the current available information and the mechanism of action of mRNA-1237 vaccine, the events of pneumonia, bronchitis and positive for SARS-CoV-2, are assessed as unlikely related.  The event of pyrexia is an expected event.
Sex: F
Vaccine: COVID19
Symptoms: Pain in extremity
Clinical narrative: A little bit of a sore arm; This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (A little bit of a sore arm) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     Concurrent medical conditions included Allergy (Patient receives an allergy shot as a maintenance for environmental allergies.).    On 24-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 24-Jan-2021, the patient experienced PAIN IN EXTREMITY (A little bit of a sore arm). At the time of the report, PAIN IN EXTREMITY (A little bit of a sore arm) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Concomitant product use was not provided. Treatment information was not provided.   Most recent FOLLOW-UP information incorporated above includes: On 15-Apr-2021: NNI
Age: 70.0
Sex: F
Vaccine: COVID19
Symptoms: Vaccination site erythema, Vaccination site swelling, Vaccination site warmth
Clinical narrative: Warm to the touch; Big red swelling reaction; Big red swelling reaction; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE WARMTH (Warm to the touch), VACCINATION SITE ERYTHEMA (Big red swelling reaction) and VACCINATION SITE SWELLING (Big red swelling reaction) in a 70-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 first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced VACCINATION SITE WARMTH (Warm to the touch), VACCINATION SITE ERYTHEMA (Big red swelling reaction) and VACCINATION SITE SWELLING (Big red swelling reaction). At the time of the report, VACCINATION SITE WARMTH (Warm to the touch), VACCINATION SITE ERYTHEMA (Big red swelling reaction) and VACCINATION SITE SWELLING (Big red swelling reaction) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Concomitant medication information was not provided.  Treatment included  Pedialyte.  Company Comment   Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded.; 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: Malaise, Myalgia, Tremor
Clinical narrative: shaky; not feeling well; achy; This spontaneous case was reported by a consumer (subsequently medically confirmed) and describes the occurrence of TREMOR (shaky), MALAISE (not feeling well) and MYALGIA (achy) in a male patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 029L20A) 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 26-Jan-2021, the patient experienced TREMOR (shaky), MALAISE (not feeling well) and MYALGIA (achy). At the time of the report, TREMOR (shaky), MALAISE (not feeling well) and MYALGIA (achy) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No concomitant medications were reported.  No treatment information was provided by the reporter.   Reporter did not allow further contact   Most recent FOLLOW-UP information incorporated above includes: On 16-Apr-2021: Follow-up information updated outcome of events to Recovered; the patient stated that he is fine and does not want additional follow-up
Age: 77.0
Sex: F
Vaccine: COVID19
Symptoms: Fatigue, Pain in extremity
Clinical narrative: Pain in arm; fatigue; This spontaneous case was reported by a consumer and describes the occurrence of FATIGUE (fatigue) and PAIN IN EXTREMITY (Pain in arm) in a 77-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 032L20A) for COVID-19 vaccination.     Concomitant products included ATORVASTATIN CALCIUM (LIPITOR ORIFARM) for an unknown indication.    On 20-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 20-Jan-2021, the patient experienced FATIGUE (fatigue). On 21-Jan-2021, the patient experienced PAIN IN EXTREMITY (Pain in arm). The patient was treated with IBUPROFEN at an unspecified dose and frequency. On 20-Jan-2021, FATIGUE (fatigue) had resolved. On 26-Jan-2021, PAIN IN EXTREMITY (Pain in arm) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.
Age: 80.0
Sex: F
Vaccine: COVID19
Symptoms: Dizziness, Nausea
Clinical narrative: Dizziness; Nausea; This spontaneous case was reported by a consumer and describes the occurrence of DIZZINESS (Dizziness) and NAUSEA (Nausea) in an 80-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On 26-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 26-Jan-2021, the patient experienced DIZZINESS (Dizziness) and NAUSEA (Nausea). At the time of the report, DIZZINESS (Dizziness) and NAUSEA (Nausea) 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.   no treatment medication provided. no concomitant medication provided.   Most recent FOLLOW-UP information incorporated above includes: On 15-Apr-2021: patient disconnected call without providing any information
Age: 67.0
Sex: U
Vaccine: COVID19
Symptoms: Urticaria
Clinical narrative: Hives on left arm; This spontaneous case was reported by a consumer and describes the occurrence of URTICARIA (Hives on left arm) in a 67-year-old patient of an unknown gender who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 007M20A) for COVID-19.     No Medical History information was reported.    On 02-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 06-Feb-2021, the patient experienced URTICARIA (Hives on left arm). At the time of the report, URTICARIA (Hives on left arm) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Concomitant product use was not provided by the reporter.  Treatment information was not provided.