chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Sex: F
Vaccine: COVID19
Symptoms: Alopecia, Asthenia, Burning sensation, Dyspnoea, Headache
Clinical narrative: losing her hair like if she was getting radiation; body weakness/hasn't energy; difficulty breathing; feels like a burning liquid was put inside of her like if she received gasoline and set up fire.; feels ancient; intense headaches; This spontaneous case was reported by a consumer and describes the occurrence of ALOPECIA (losing her hair like if she was getting radiation), ASTHENIA (body weakness/hasn't energy), DYSPNOEA (difficulty breathing), BURNING SENSATION (feels like a burning liquid was put inside of her like if she received gasoline and set up fire.) and VACCINATION COMPLICATION (feels ancient) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     Concurrent medical conditions included Diabetic and Multiple allergies.    On 24-Apr-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced ALOPECIA (losing her hair like if she was getting radiation), ASTHENIA (body weakness/hasn't energy), DYSPNOEA (difficulty breathing), BURNING SENSATION (feels like a burning liquid was put inside of her like if she received gasoline and set up fire.), VACCINATION COMPLICATION (feels ancient) and HEADACHE (intense headaches). At the time of the report, ALOPECIA (losing her hair like if she was getting radiation), ASTHENIA (body weakness/hasn't energy), DYSPNOEA (difficulty breathing), BURNING SENSATION (feels like a burning liquid was put inside of her like if she received gasoline and set up fire.), VACCINATION COMPLICATION (feels ancient) and HEADACHE (intense headaches) outcome was unknown.            No concomitant medication details was reported. No treatment medication details was reported.   This case was linked to MOD-2021-074683 (Patient Link).
Sex: F
Vaccine: COVID19
Symptoms: Vaccination complication
Clinical narrative: losing her hair like if she was getting radiation; body weakness/hasn't energy; difficulty breathing; feels like a burning liquid was put inside of her like if she received gasoline and set up fire.; feels ancient; intense headaches; This spontaneous case was reported by a consumer and describes the occurrence of ALOPECIA (losing her hair like if she was getting radiation), ASTHENIA (body weakness/hasn't energy), DYSPNOEA (difficulty breathing), BURNING SENSATION (feels like a burning liquid was put inside of her like if she received gasoline and set up fire.) and VACCINATION COMPLICATION (feels ancient) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     Concurrent medical conditions included Diabetic and Multiple allergies.    On 24-Apr-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced ALOPECIA (losing her hair like if she was getting radiation), ASTHENIA (body weakness/hasn't energy), DYSPNOEA (difficulty breathing), BURNING SENSATION (feels like a burning liquid was put inside of her like if she received gasoline and set up fire.), VACCINATION COMPLICATION (feels ancient) and HEADACHE (intense headaches). At the time of the report, ALOPECIA (losing her hair like if she was getting radiation), ASTHENIA (body weakness/hasn't energy), DYSPNOEA (difficulty breathing), BURNING SENSATION (feels like a burning liquid was put inside of her like if she received gasoline and set up fire.), VACCINATION COMPLICATION (feels ancient) and HEADACHE (intense headaches) outcome was unknown.            No concomitant medication details was reported. No treatment medication details was reported.   This case was linked to MOD-2021-074683 (Patient Link).
Sex: U
Vaccine: COVID19
Symptoms: Product dose omission issue
Clinical narrative: very late getting second shot; This spontaneous case was reported by a consumer and describes the occurrence of PRODUCT DOSE OMISSION ISSUE (very late getting second 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 PRODUCT DOSE OMISSION ISSUE (very late getting second shot). At the time of the report, PRODUCT DOSE OMISSION ISSUE (very late getting second shot) outcome was unknown.            No concomitant medications were reported. No treatment details were reported.   This case was linked to MOD-2021-295769 (Patient Link).
Age: 46.0
Sex: F
Vaccine: COVID19
Symptoms: Dermatitis allergic, Hypersensitivity, Loss of personal independence in daily activities, Vasculitis
Clinical narrative: vasculitis; Having allergic reactions to products that I have used that whole time; Unable to do my job without special accommodations; Spongiotic psoriaform dermatitis with lymphocytes and hystocytes/ Allergic skin reactions; This spontaneous case was reported by a consumer and describes the occurrence of DERMATITIS ALLERGIC (Spongiotic psoriaform dermatitis with lymphocytes and hystocytes/ Allergic skin reactions), VASCULITIS (vasculitis), HYPERSENSITIVITY (Having allergic reactions to products that I have used that whole time) and LOSS OF PERSONAL INDEPENDENCE IN DAILY ACTIVITIES (Unable to do my job without special accommodations) in a 47-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. #025L20A and #011J20A) for COVID-19 vaccination.     The patient's past medical history included Nephrostomy. Concurrent medical conditions included Drug allergy (Cipro), Drug allergy (Vanc), Fruit allergy (Mellon), Allergy to sting (Bees) and Penicillin allergy (Allergy to PCN).   On 27-Dec-2020, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 19-Jan-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 15-May-2021, the patient experienced DERMATITIS ALLERGIC (Spongiotic psoriaform dermatitis with lymphocytes and hystocytes/ Allergic skin reactions). On an unknown date, the patient experienced VASCULITIS (vasculitis), HYPERSENSITIVITY (Having allergic reactions to products that I have used that whole time) and LOSS OF PERSONAL INDEPENDENCE IN DAILY ACTIVITIES (Unable to do my job without special accommodations). At the time of the report, DERMATITIS ALLERGIC (Spongiotic psoriaform dermatitis with lymphocytes and hystocytes/ Allergic skin reactions) had not resolved and VASCULITIS (vasculitis), HYPERSENSITIVITY (Having allergic reactions to products that I have used that whole time) and LOSS OF PERSONAL INDEPENDENCE IN DAILY ACTIVITIES (Unable to do my job without special accommodations) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   Concomitant product was not provided by the reporter. Took several courses of steroids, tried several creams and ointments as a treatment.  Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded.   Most recent FOLLOW-UP information incorporated above includes: On 25-Aug-2021: Significant follow-up added (Nephrostomy) on 25-Aug-2021; 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: 25.0
Sex: F
Vaccine: COVID19
Symptoms: Exposure during pregnancy
Clinical narrative: Received the vaccine being pregnant; This spontaneous prospective pregnancy case was reported by a consumer and describes the occurrence of EXPOSURE DURING PREGNANCY in a 25-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 039C21A) for COVID-19 vaccination.     No Medical History information was reported.    On 13-Aug-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 17-Feb-2021 and the estimated date of delivery was 24-Nov-2021. On 13-Aug-2021, the patient experienced EXPOSURE DURING PREGNANCY. The patient received mRNA-1273 (Moderna COVID-19 Vaccine) beginning around the twenty-fifth week of the pregnancy. On 13-Aug-2021, EXPOSURE DURING PREGNANCY (Received the vaccine being pregnant) had resolved.        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 by the reporter. This is a case of product exposure during pregnancy with no associated AEs for this 25-year-old female. Further information has been requested.
Age: 36.0
Sex: F
Vaccine: COVID19
Symptoms: Feeling abnormal, Headache
Clinical narrative: headaches following; Fuzzy headed/ should make important decisions type feeling/mind has started to clear but continues to have a bit of fuzziness; This spontaneous case was reported by a consumer and describes the occurrence of FEELING ABNORMAL (Fuzzy headed/ should make important decisions type feeling/mind has started to clear but continues to have a bit of fuzziness) and HEADACHE (headaches following) in a 36-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 002f21) for COVID-19 vaccination.     The patient's past medical history included Pregnancy induced hypertension.    On 22-Aug-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 23-Aug-2021, the patient experienced FEELING ABNORMAL (Fuzzy headed/ should make important decisions type feeling/mind has started to clear but continues to have a bit of fuzziness). On an unknown date, the patient experienced HEADACHE (headaches following). At the time of the report, FEELING ABNORMAL (Fuzzy headed/ should make important decisions type feeling/mind has started to clear but continues to have a bit of fuzziness) was resolving and HEADACHE (headaches following) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       It was stated have not seen physician yet.  No concomitant medication was reported.                   No treatment medication was reported.
Sex: M
Vaccine: COVID19
Symptoms: Illness, Muscle spasms
Clinical narrative: he got real sick but that was normal; Muscle spasms; This spontaneous case was reported by a consumer and describes the occurrence of ILLNESS (he got real sick but that was normal) and MUSCLE SPASMS (Muscle spasms) in a male patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 010M20A and 025L20A) for COVID-19 vaccination.     Concurrent medical conditions included Cancer. Concomitant products included FLUOROURACIL (EFUDEX) for Cancer.   On 31-Dec-2020, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 28-Jan-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient experienced ILLNESS (he got real sick but that was normal) and MUSCLE SPASMS (Muscle spasms). At the time of the report, ILLNESS (he got real sick but that was normal) outcome was unknown and MUSCLE SPASMS (Muscle spasms) had resolved.            Treatment information was not provided.  Patient was scheduled appointment for 3rd dose on the day of reporting.
Age: 75.0
Sex: F
Vaccine: COVID19
Symptoms: Product dose omission issue
Clinical narrative: has not gotten her second dose, yet.; This spontaneous case was reported by a pharmacist and describes the occurrence of PRODUCT DOSE OMISSION ISSUE (has not gotten her second dose, yet.) in a 75-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On 11-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 PRODUCT DOSE OMISSION ISSUE (has not gotten her second dose, yet.). At the time of the report, PRODUCT DOSE OMISSION ISSUE (has not gotten her second dose, yet.) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No Concomitent informations were reported. No Treatment informations were reported.   Reporter did not allow further contact
Sex: F
Vaccine: COVID19
Symptoms: Headache, Pyrexia, SARS-CoV-2 antibody test
Clinical narrative: fever; headaches; This spontaneous case was reported by a consumer and describes the occurrence of PYREXIA (fever) and HEADACHE (headaches) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.   On an unknown date, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (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 03-Mar-2021, the patient experienced PYREXIA (fever) and HEADACHE (headaches). The patient was treated with PARACETAMOL (TYLENOL) for Headache and Fever, at an unspecified dose and frequency. On 04-Mar-2021, PYREXIA (fever) and HEADACHE (headaches) had resolved.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): In August 2021, SARS-CoV-2 antibody test: high (High) greater than 2500.         Patient had both doses of the Moderna COVID-19 and had a bad reaction after the second shot (which she think on 03-Mar-2021). She had fever and headaches but as she expected them she did not report them. By the next day she was fine, the symptoms lasted one day. She would like to know if she should take the booster shot.  Concomitant medication use was unknown
Sex: M
Vaccine: COVID19
Symptoms: Pruritus, Rash
Clinical narrative: very itchy; Rash; This spontaneous case was reported by a consumer and describes the occurrence of PRURITUS and RASH 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 first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced PRURITUS and RASH. At the time of the report, PRURITUS and RASH outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) was unknown.       No concomitant medication details was reported. No treatment medication details was reported.
Age: 36.0
Sex: M
Vaccine: COVID19
Symptoms: Platelet aggregation abnormal
Clinical narrative: Blood test two weeks after vaccine shows blood platelets clumping; This spontaneous case was reported by a consumer and describes the occurrence of PLATELET AGGREGATION ABNORMAL (Blood test two weeks after vaccine shows blood platelets clumping) in a 36-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     Concurrent medical conditions included Psoriatic arthritis (Patient is dealing with psoriatic arthritis for 3 years.) and Autoimmune disorder. Concomitant products included TOFACITINIB CITRATE (XELJANZ), ADALIMUMAB (HUMIRA) and ETANERCEPT (ENBREL) for Autoimmune disorder, ATORVASTATIN and VERAPAMIL for an unknown indication.    On 05-Aug-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced PLATELET AGGREGATION ABNORMAL (Blood test two weeks after vaccine shows blood platelets clumping). At the time of the report, PLATELET AGGREGATION ABNORMAL (Blood test two weeks after vaccine shows blood platelets clumping) had not resolved.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, Platelet aggregation test: abnormal (abnormal) abnormal.     The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No treatment medication were provided.   Most recent FOLLOW-UP information incorporated above includes: On 25-Aug-2021: Follow up document contains no new information.
Age: 29.0
Sex: F
Vaccine: COVID19
Symptoms: Dizziness, Dysphagia, Headache, Irritability, Oropharyngeal pain
Clinical narrative: period two week earlier than it normally would occur; difficult to swallow; sore throat; severe headaches; dizziness; irritability; This spontaneous case was reported by a consumer and describes the occurrence of OROPHARYNGEAL PAIN (sore throat), HEADACHE (severe headaches), DIZZINESS (dizziness), IRRITABILITY (irritability) and POLYMENORRHOEA (period two week earlier than it normally would occur) in a 29-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 044B21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     no medical history was provided by reporter.  Concomitant products included AMFETAMINE ASPARTATE, AMFETAMINE SULFATE, DEXAMFETAMINE SACCHARATE, DEXAMFETAMINE SULFATE (ADDERALL) and OMEPRAZOLE (PROTONIX [OMEPRAZOLE]) for an unknown indication.    On 13-Aug-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 20-Aug-2021, the patient experienced OROPHARYNGEAL PAIN (sore throat), HEADACHE (severe headaches), DIZZINESS (dizziness) and IRRITABILITY (irritability). On an unknown date, the patient experienced POLYMENORRHOEA (period two week earlier than it normally would occur) and DYSPHAGIA (difficult to swallow). The patient was treated with IBUPROFEN for Adverse event, at an unspecified dose and frequency. At the time of the report, OROPHARYNGEAL PAIN (sore throat), HEADACHE (severe headaches), DIZZINESS (dizziness), IRRITABILITY (irritability), POLYMENORRHOEA (period two week earlier than it normally would occur) and DYSPHAGIA (difficult to swallow) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Concomitant products included Limitol.
Age: 29.0
Sex: F
Vaccine: COVID19
Symptoms: Polymenorrhoea
Clinical narrative: period two week earlier than it normally would occur; difficult to swallow; sore throat; severe headaches; dizziness; irritability; This spontaneous case was reported by a consumer and describes the occurrence of OROPHARYNGEAL PAIN (sore throat), HEADACHE (severe headaches), DIZZINESS (dizziness), IRRITABILITY (irritability) and POLYMENORRHOEA (period two week earlier than it normally would occur) in a 29-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 044B21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     no medical history was provided by reporter.  Concomitant products included AMFETAMINE ASPARTATE, AMFETAMINE SULFATE, DEXAMFETAMINE SACCHARATE, DEXAMFETAMINE SULFATE (ADDERALL) and OMEPRAZOLE (PROTONIX [OMEPRAZOLE]) for an unknown indication.    On 13-Aug-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 20-Aug-2021, the patient experienced OROPHARYNGEAL PAIN (sore throat), HEADACHE (severe headaches), DIZZINESS (dizziness) and IRRITABILITY (irritability). On an unknown date, the patient experienced POLYMENORRHOEA (period two week earlier than it normally would occur) and DYSPHAGIA (difficult to swallow). The patient was treated with IBUPROFEN for Adverse event, at an unspecified dose and frequency. At the time of the report, OROPHARYNGEAL PAIN (sore throat), HEADACHE (severe headaches), DIZZINESS (dizziness), IRRITABILITY (irritability), POLYMENORRHOEA (period two week earlier than it normally would occur) and DYSPHAGIA (difficult to swallow) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Concomitant products included Limitol.
Age: 49.0
Sex: F
Vaccine: COVID19
Symptoms: Back pain, Body temperature, Bone pain, Pain in extremity, Pyrexia
Clinical narrative: back pain,says a spot in back hurts when she is on her feet all day; collarbone pain she is eperiencing; could not raise left arm, felt like "it was pummeled with sledge hammer"; low grade fever last night 99 degrees F; This spontaneous case was reported by a consumer and describes the occurrence of BACK PAIN (back pain,says a spot in back hurts when she is on her feet all day), BONE PAIN (collarbone pain she is eperiencing), PAIN IN EXTREMITY (could not raise left arm, felt like "it was pummeled with sledge hammer") and PYREXIA (low grade fever last night 99 degrees F) in a 49-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 009C211A) for COVID-19 vaccination.     No medical history was provided by the reporter.  The patient's past medical history included Broken collarbone (when she was 14 years old) and COVID-19 on 23-Jun-2021. Concomitant products included FAMOTIDINE and ESCITALOPRAM OXALATE (LEXAPRO) for an unknown indication.    On 23-Aug-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced BACK PAIN (back pain,says a spot in back hurts when she is on her feet all day), BONE PAIN (collarbone pain she is eperiencing), PAIN IN EXTREMITY (could not raise left arm, felt like "it was pummeled with sledge hammer") and PYREXIA (low grade fever last night 99 degrees F). The patient was treated with PARACETAMOL (TYLENOL) for Back pain, at an unspecified dose and frequency. At the time of the report, BACK PAIN (back pain,says a spot in back hurts when she is on her feet all day), BONE PAIN (collarbone pain she is eperiencing), PAIN IN EXTREMITY (could not raise left arm, felt like "it was pummeled with sledge hammer") and PYREXIA (low grade fever last night 99 degrees F) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, Body temperature: 99 degrees f (High) 99 degrees F.     The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.
Sex: U
Vaccine: COVID19
Symptoms: Oropharyngeal pain
Clinical narrative: sick with a sore throat; This spontaneous case was reported by a consumer and describes the occurrence of OROPHARYNGEAL PAIN (sick with a sore throat) in a patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. Unknown) for COVID-19 vaccination.     No Medical History information was reported.    On an unknown date, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced OROPHARYNGEAL PAIN (sick with a sore throat). At the time of the report, OROPHARYNGEAL PAIN (sick with a sore throat) 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.
Age: 66.0
Sex: F
Vaccine: COVID19
Symptoms: Expired product administered
Clinical narrative: patient received a dose of the vaccine from an expired vial; This spontaneous case was reported by an other health care professional and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (patient received a dose of the vaccine from an expired vial) in a 66-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 25-Aug-2021, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 25-Aug-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (patient received a dose of the vaccine from an expired vial). On 25-Aug-2021, EXPIRED PRODUCT ADMINISTERED (patient received a dose of the vaccine from an expired vial) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant medications were provided. No treatment medications were provided.  Date the vial was initially stored in the refrigerator: 3 days ago. The vial was initially stored in the refrigerator 3 days ago and it did not undergo any temperature excursion. The vial was removed from the refrigerator and carried to the facility in refrigerated cooler where the patients are home bound.
Age: 30.0
Sex: F
Vaccine: COVID19
Symptoms: Exposure during pregnancy, Product dose omission issue
Clinical narrative: Missed 2nd dose; Possibly pregnant during 1st shot; This spontaneous prospective pregnancy case was reported by a consumer and describes the occurrence of EXPOSURE DURING PREGNANCY (Possibly pregnant during 1st shot) and PRODUCT DOSE OMISSION ISSUE (Missed 2nd dose) in a 30-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 032B21A) for COVID-19 vaccination.     No Medical History information was reported.    On 14-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. Last menstrual period and estimated date of delivery were not provided. On 14-Apr-2021, the patient experienced EXPOSURE DURING PREGNANCY (Possibly pregnant during 1st shot). On an unknown date, the patient experienced PRODUCT DOSE OMISSION ISSUE (Missed 2nd dose). On 14-Apr-2021, EXPOSURE DURING PREGNANCY (Possibly pregnant during 1st shot) had resolved. At the time of the report, PRODUCT DOSE OMISSION ISSUE (Missed 2nd dose) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No concomitant medication was reported by the reporter. No treatment was reported by the reporter.; Sender's Comments: Very limited information regarding these events has been provided at this time.  Further information has been requested.
Age: 78.0
Sex: F
Vaccine: COVID19
Symptoms: Expired product administered
Clinical narrative: Greater than 12 hours after initial vial puncture; This spontaneous case was reported by a pharmacist and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Greater than 12 hours after initial vial puncture) in a 78-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 017E21A) for COVID-19 vaccination.     No Medical History information was reported.    On 25-Aug-2021, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced EXPIRED PRODUCT ADMINISTERED (Greater than 12 hours after initial vial puncture). At the time of the report, EXPIRED PRODUCT ADMINISTERED (Greater than 12 hours after initial vial puncture) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown Route), the reporter did not provide any causality assessments.   No concurrent and treatment medication was reported by patient.  The patient received their vaccine at least 4 hours past expiration, After each withdrawal the vial was put back in the fridge.
Age: 22.0
Sex: F
Vaccine: COVID19
Symptoms: Expired product administered
Clinical narrative: Greater than 12 hours after initial vial puncture; This spontaneous case was reported by a pharmacist and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Greater than 12 hours after initial vial puncture) in a 22-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 017E21A) for COVID-19 vaccination.     No Medical History information was reported.    On 25-Aug-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced EXPIRED PRODUCT ADMINISTERED (Greater than 12 hours after initial vial puncture). At the time of the report, EXPIRED PRODUCT ADMINISTERED (Greater than 12 hours after initial vial puncture) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   Concomitant medication were not reported. Treatment medication were not reported.
Age: 80.0
Sex: F
Vaccine: COVID19
Symptoms: Arthralgia, Back pain, Discomfort, Exercise tolerance decreased, Myalgia
Clinical narrative: Experienced pure pain in both of her arms, still has pain in her hand; Cold; Pain comes down in the muscle to across her back; Uncomfortable; Cannot exercise; Pain comes down in the muscle to across her shoulder; Soreness, muscle pain, soreness is never ending, soreness goes and comes back; This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (Experienced pure pain in both of her arms, still has pain in her hand), NASOPHARYNGITIS (Cold), BACK PAIN (Pain comes down in the muscle to across her back), DISCOMFORT (Uncomfortable) and EXERCISE TOLERANCE DECREASED (Cannot exercise) in an 80-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.     Concomitant products included LATANOPROST, AMLODIPINE and HYDROCHLOROTHIAZIDE for an unknown indication.    On 14-May-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 (Experienced pure pain in both of her arms, still has pain in her hand), NASOPHARYNGITIS (Cold), BACK PAIN (Pain comes down in the muscle to across her back), DISCOMFORT (Uncomfortable), EXERCISE TOLERANCE DECREASED (Cannot exercise), ARTHRALGIA (Pain comes down in the muscle to across her shoulder) and MYALGIA (Soreness, muscle pain, soreness is never ending, soreness goes and comes back). The patient was treated with CAFFEINE, PARACETAMOL (EXCEDRIN [CAFFEINE;PARACETAMOL]) for Adverse event, at an unspecified dose and frequency. At the time of the report, PAIN IN EXTREMITY (Experienced pure pain in both of her arms, still has pain in her hand) had not resolved and NASOPHARYNGITIS (Cold), BACK PAIN (Pain comes down in the muscle to across her back), DISCOMFORT (Uncomfortable), EXERCISE TOLERANCE DECREASED (Cannot exercise), ARTHRALGIA (Pain comes down in the muscle to across her shoulder) and MYALGIA (Soreness, muscle pain, soreness is never ending, soreness goes and comes back) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       This case was linked to MOD-2021-296321 (Patient Link).
Age: 80.0
Sex: F
Vaccine: COVID19
Symptoms: Nasopharyngitis, Pain in extremity
Clinical narrative: Experienced pure pain in both of her arms, still has pain in her hand; Cold; Pain comes down in the muscle to across her back; Uncomfortable; Cannot exercise; Pain comes down in the muscle to across her shoulder; Soreness, muscle pain, soreness is never ending, soreness goes and comes back; This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (Experienced pure pain in both of her arms, still has pain in her hand), NASOPHARYNGITIS (Cold), BACK PAIN (Pain comes down in the muscle to across her back), DISCOMFORT (Uncomfortable) and EXERCISE TOLERANCE DECREASED (Cannot exercise) in an 80-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.     Concomitant products included LATANOPROST, AMLODIPINE and HYDROCHLOROTHIAZIDE for an unknown indication.    On 14-May-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 (Experienced pure pain in both of her arms, still has pain in her hand), NASOPHARYNGITIS (Cold), BACK PAIN (Pain comes down in the muscle to across her back), DISCOMFORT (Uncomfortable), EXERCISE TOLERANCE DECREASED (Cannot exercise), ARTHRALGIA (Pain comes down in the muscle to across her shoulder) and MYALGIA (Soreness, muscle pain, soreness is never ending, soreness goes and comes back). The patient was treated with CAFFEINE, PARACETAMOL (EXCEDRIN [CAFFEINE;PARACETAMOL]) for Adverse event, at an unspecified dose and frequency. At the time of the report, PAIN IN EXTREMITY (Experienced pure pain in both of her arms, still has pain in her hand) had not resolved and NASOPHARYNGITIS (Cold), BACK PAIN (Pain comes down in the muscle to across her back), DISCOMFORT (Uncomfortable), EXERCISE TOLERANCE DECREASED (Cannot exercise), ARTHRALGIA (Pain comes down in the muscle to across her shoulder) and MYALGIA (Soreness, muscle pain, soreness is never ending, soreness goes and comes back) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       This case was linked to MOD-2021-296321 (Patient Link).
Sex: U
Vaccine: COVID19
Symptoms: Tinnitus
Clinical narrative: tinnitus; Based on the current case data, this case has been classified as invalid. This spontaneous case was reported by a consumer and describes the occurrence of TINNITUS (tinnitus) in a  patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On an unknown date, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced TINNITUS (tinnitus). At the time of the report, TINNITUS (tinnitus) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No concomitant medications were reported. No treatment medications were reported.
Age: 44.0
Sex: M
Vaccine: COVID19
Symptoms: Myalgia
Clinical narrative: she got a sore arm with the 1st; This spontaneous case was reported by a consumer and describes the occurrence of MYALGIA (she got a sore arm with the 1st) in a 44-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 001A21A) for COVID-19 vaccination.     Concomitant products included LAMOTRIGINE (LAMICTAL), OXCARBAZEPINE, GABAPENTIN, QUETIAPINE, HYDROCHLOROTHIAZIDE, OMEPRAZOLE, NALTREXONE HYDROCHLORIDE (NALTREXONE [NALTREXONE HYDROCHLORIDE]), PROBIOTICS NOS, LYSINE, COLECALCIFEROL (D3), MELATONIN, NATTOKINASE, RESVERATROL, GLYCERINE MONOLAURATE, INOSINE (MONOLAURIN [GLYCERINE MONOLAURATE;INOSINE]), FISH OIL, ASCORBIC ACID (VIT C), LEVETIRACETAM (LEVRA) and IMMUNOGLOBULIN G HUMAN (IGG) for an unknown indication.    On 26-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced MYALGIA (she got a sore arm with the 1st). At the time of the report, MYALGIA (she got a sore arm with the 1st) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Patient reported concomitant medication as sertiamen.  No treatment medication was reported by patient.
Sex: U
Vaccine: COVID19
Symptoms: Expired product administered
Clinical narrative: 3 patients administered expired doses from 27July2021; Based on the current case data, this case has been classified as invalid. This spontaneous case was reported by a pharmacist and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (3 patients administered expired doses from 27July2021) 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 23-Aug-2021, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 23-Aug-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (3 patients administered expired doses from 27July2021). At the time of the report, EXPIRED PRODUCT ADMINISTERED (3 patients administered expired doses from 27July2021) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   Concomitant medication was not reported.  Treatment information was not reported.   Most recent FOLLOW-UP information incorporated above includes: On 31-Aug-2021: follow up information received on 31-AUG-2021 contains No new information
Sex: U
Vaccine: COVID19
Symptoms: Asthenia, Back pain, Decreased appetite, Malaise, Pain
Clinical narrative: Back was hurting; No appetite; Has absolutely no energy; Just doesn't feel ok; Pain; This case was received via an unknown source (no reference has been entered for a health authority or license partner) on 25-Aug-2021 and was forwarded to the company on 25-Aug-2021.    This spontaneous case was reported by a consumer and describes the occurrence of BACK PAIN (Back was hurting), DECREASED APPETITE (No appetite), ASTHENIA (Has absolutely no energy), MALAISE (Just doesn't feel ok) and PAIN (Pain) in a patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     Concurrent medical conditions included Spinal stenosis. Concomitant products included PARACETAMOL (TYLENOL) and IBUPROFEN for Spinal stenosis.   On an unknown date, the patient received third 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) (unknown route) dosage was changed to 1 dosage form and 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 BACK PAIN (Back was hurting), DECREASED APPETITE (No appetite), ASTHENIA (Has absolutely no energy), MALAISE (Just doesn't feel ok) and PAIN (Pain). At the time of the report, BACK PAIN (Back was hurting), DECREASED APPETITE (No appetite), ASTHENIA (Has absolutely no energy), MALAISE (Just doesn't feel ok) and PAIN (Pain) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) and mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No concomitant medication were reported. No treatment information was reported.   This case was linked to MOD-2021-296545, MOD-2021-022507 (Patient Link).
Age: 60.0
Sex: F
Vaccine: COVID19
Symptoms: Abdominal pain, Asthenia, Diarrhoea, Feeling abnormal, Vaccination site pain
Clinical narrative: felt badly; sore injection site right arm; vomiting; abdominal pain; weak; diarrhea; This spontaneous case was reported by a consumer and describes the occurrence of ABDOMINAL PAIN (abdominal pain), ASTHENIA (weak), DIARRHOEA (diarrhea), FEELING ABNORMAL (felt badly) and VACCINATION SITE PAIN (sore injection site right arm) in a 60-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No medical history was provided by reporter.  Concomitant products included MECLOZINE HYDROCHLORIDE (BONINE) for an unknown indication.   On 02-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 02-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 24-Aug-2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 24-Aug-2021, the patient experienced ABDOMINAL PAIN (abdominal pain), ASTHENIA (weak), DIARRHOEA (diarrhea), VACCINATION SITE PAIN (sore injection site right arm) and VOMITING (vomiting). On an unknown date, the patient experienced FEELING ABNORMAL (felt badly). At the time of the report, ABDOMINAL PAIN (abdominal pain), ASTHENIA (weak), DIARRHOEA (diarrhea), FEELING ABNORMAL (felt badly), VACCINATION SITE PAIN (sore injection site right arm) and VOMITING (vomiting) outcome was unknown.            Treatment medications were not provided by reporter.   This case was linked to MOD-2021-296556 (Patient Link).
Age: 60.0
Sex: F
Vaccine: COVID19
Symptoms: Vomiting
Clinical narrative: felt badly; sore injection site right arm; vomiting; abdominal pain; weak; diarrhea; This spontaneous case was reported by a consumer and describes the occurrence of ABDOMINAL PAIN (abdominal pain), ASTHENIA (weak), DIARRHOEA (diarrhea), FEELING ABNORMAL (felt badly) and VACCINATION SITE PAIN (sore injection site right arm) in a 60-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No medical history was provided by reporter.  Concomitant products included MECLOZINE HYDROCHLORIDE (BONINE) for an unknown indication.   On 02-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 02-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 24-Aug-2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 24-Aug-2021, the patient experienced ABDOMINAL PAIN (abdominal pain), ASTHENIA (weak), DIARRHOEA (diarrhea), VACCINATION SITE PAIN (sore injection site right arm) and VOMITING (vomiting). On an unknown date, the patient experienced FEELING ABNORMAL (felt badly). At the time of the report, ABDOMINAL PAIN (abdominal pain), ASTHENIA (weak), DIARRHOEA (diarrhea), FEELING ABNORMAL (felt badly), VACCINATION SITE PAIN (sore injection site right arm) and VOMITING (vomiting) outcome was unknown.            Treatment medications were not provided by reporter.   This case was linked to MOD-2021-296556 (Patient Link).
Age: 71.0
Sex: F
Vaccine: COVID19
Symptoms: Alopecia
Clinical narrative: Hair loss, entire strand including the bulb; This spontaneous case was reported by a consumer and describes the occurrence of ALOPECIA (Hair loss, entire strand including the bulb) in a 71-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 042L20A and 020BZ1A) for COVID-19 vaccination.     Concomitant products included DILTIAZEM HYDROCHLORIDE (CARDIZEM [DILTIAZEM HYDROCHLORIDE]), ROSUVASTATIN CALCIUM (CRESTOR), FOLIC ACID, ESTROGENS CONJUGATED (PREMARIN), GABAPENTIN (NEURONTIN), ACETYLSALICYLIC ACID (ASPIRIN (E.C.)) and CENTRUM VITAMINTS for an unknown indication.   On 22-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 22-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. In August 2021, the patient experienced ALOPECIA (Hair loss, entire strand including the bulb). At the time of the report, ALOPECIA (Hair loss, entire strand including the bulb) outcome was unknown.            No Treatment medications were reported.
Age: 68.0
Sex: M
Vaccine: COVID19
Symptoms: Arthralgia
Clinical narrative: Pain in shoulder; This spontaneous case was reported by a consumer and describes the occurrence of ARTHRALGIA (Pain in shoulder) in a 68-year-old male 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 dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced ARTHRALGIA (Pain in shoulder). At the time of the report, ARTHRALGIA (Pain in shoulder) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No concomitant medication information were provided. No treatment information were provided.
Sex: U
Vaccine: COVID19
Symptoms: Decreased appetite, Nausea, Weight decreased
Clinical narrative: lost 23 pounds without trying; Not really hungry; sometimes feel nauseous after eating; This spontaneous case was reported by a consumer and describes the occurrence of WEIGHT DECREASED (lost 23 pounds without trying), DECREASED APPETITE (Not really hungry) and NAUSEA (sometimes feel nauseous after eating) in a  patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On an unknown date, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced WEIGHT DECREASED (lost 23 pounds without trying), DECREASED APPETITE (Not really hungry) and NAUSEA (sometimes feel nauseous after eating). At the time of the report, WEIGHT DECREASED (lost 23 pounds without trying), DECREASED APPETITE (Not really hungry) and NAUSEA (sometimes feel nauseous after eating) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No concomitant medications were reported.  Treatment information was not provided.
Sex: U
Vaccine: COVID19
Symptoms: Urticaria
Clinical narrative: I got hives from the vaccine back in May of this year.; This spontaneous case was reported by a consumer and describes the occurrence of URTICARIA (I got hives from the vaccine back in May of this year.) 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. In May 2021, the patient experienced URTICARIA (I got hives from the vaccine back in May of this year.). At the time of the report, URTICARIA (I got hives from the vaccine back in May of this year.) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       The concomitant history was not reported.   The treatment history was not provided.