chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 79.0
Sex: M
Vaccine: COVID19
Symptoms: Headache, Lethargy, Myalgia, Nausea, Productive cough
Clinical narrative: Appetite lost; Lethargic; diarrhea; little bit of shortness of breath at times; coughing up phlegm when using their CPAP machine at night; muscle pain; headache\ pain in the right temple; feeling like they are going to vomit; Fatigue; chills; This spontaneous case was reported by a consumer and describes the occurrence of DECREASED APPETITE (Appetite lost), LETHARGY (Lethargic), DIARRHOEA (diarrhea), DYSPNOEA (little bit of shortness of breath at times) and PRODUCTIVE COUGH (coughing up phlegm when using their CPAP machine at night) in a 79-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 019B21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No medical history information was provided.     On 04-Aug-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 04-Aug-2021, the patient experienced DECREASED APPETITE (Appetite lost), LETHARGY (Lethargic), DIARRHOEA (diarrhea), DYSPNOEA (little bit of shortness of breath at times), PRODUCTIVE COUGH (coughing up phlegm when using their CPAP machine at night), MYALGIA (muscle pain), HEADACHE (headache\ pain in the right temple), NAUSEA (feeling like they are going to vomit), FATIGUE (Fatigue) and CHILLS (chills). The patient was treated with NAPROXEN SODIUM (ALEVE) for Symptomatic treatment, at an unspecified dose and frequency. At the time of the report, DECREASED APPETITE (Appetite lost), LETHARGY (Lethargic), DYSPNOEA (little bit of shortness of breath at times), PRODUCTIVE COUGH (coughing up phlegm when using their CPAP machine at night), MYALGIA (muscle pain), HEADACHE (headache\ pain in the right temple), NAUSEA (feeling like they are going to vomit), FATIGUE (Fatigue) and CHILLS (chills) had not resolved and DIARRHOEA (diarrhea) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       Concomitant product use was not provided by the reporter.  Treatment included ice packs, and rest to help with the symptoms.
Age: 65.0
Sex: M
Vaccine: COVID19
Symptoms: Expired product administered
Clinical narrative: 2nd dose administered after 24 hours at proper room temperature; This spontaneous case was reported by a pharmacist and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (2nd dose administered after 24 hours at proper room temperature) in a 65-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 088D21A) for COVID-19 vaccination.     No Medical History information was reported.   On 06-Aug-2021 at 1:30 PM, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 06-Aug-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (2nd dose administered after 24 hours at proper room temperature). At the time of the report, EXPIRED PRODUCT ADMINISTERED (2nd dose administered after 24 hours at proper room temperature) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   Reporter states that a vial was removed from the proper refrigerated temperature and punctured at 11:54 am  05-AUG-2021. After puncture, the vial was removed from the refrigerator and kept at 65F to 66F until a dose was given to a patient at 1:30 pm  06-AUG-2021.  On 30th of July,2021 vial was moved from freezer to refrigerator.  No concomitant medication was provided.  Treatment medication was not provided by the reporter.   Most recent FOLLOW-UP information incorporated above includes: On 13-Aug-2021: Follow up received on 13 AUG 2021 and Pharmacy address was updated. Vials details was added.
Age: 64.0
Sex: M
Vaccine: COVID19
Symptoms: Interchange of vaccine products
Clinical narrative: Johnson and Johnson Covid-19 vaccine given on 03Mar2021 and Moderna Covid-19vaccine given on 04Aug2021; This spontaneous case was reported by a pharmacist and describes the occurrence of INTERCHANGE OF VACCINE PRODUCTS (Johnson and Johnson Covid-19 vaccine given on 03Mar2021 and Moderna Covid-19vaccine given on 04Aug2021) in a 64-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 088D21A) for COVID-19 vaccination.     Previously administered products included for an unreported indication: COVID-19 VACCINE (lot number 1805018 and expiration date not provided. This was given at 0.5ml intramuscular on the right deltoid.) on 03-Mar-2021.    On 04-Aug-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) .5 milliliter. On 04-Aug-2021, the patient experienced INTERCHANGE OF VACCINE PRODUCTS (Johnson and Johnson Covid-19 vaccine given on 03Mar2021 and Moderna Covid-19vaccine given on 04Aug2021). On 04-Aug-2021, INTERCHANGE OF VACCINE PRODUCTS (Johnson and Johnson Covid-19 vaccine given on 03Mar2021 and Moderna Covid-19vaccine given on 04Aug2021) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   No Concomitant medications were provided by the reporter. No Treatment Information was provided by the reporter.
Sex: M
Vaccine: COVID19
Symptoms: Chills, Nasopharyngitis
Clinical narrative: A hot cold for 10 hours; Chills for 10 hours; This spontaneous case was reported by an other health care professional and describes the occurrence of NASOPHARYNGITIS (A hot cold for 10 hours) and CHILLS (Chills for 10 hours) in a male patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. Unknown) for COVID-19 vaccination.     Previously administered products included for Product used for unknown indication: Flu shot.    In March 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 NASOPHARYNGITIS (A hot cold for 10 hours) and CHILLS (Chills for 10 hours). At the time of the report, NASOPHARYNGITIS (A hot cold for 10 hours) and CHILLS (Chills for 10 hours) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitants were provided  No treatment medications  were provided   This case was linked to MOD-2021-282222 (Patient Link).
Sex: U
Vaccine: COVID19
Symptoms: Inappropriate schedule of product administration
Clinical narrative: inappropriate schedule of vaccine administered; 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 INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (inappropriate schedule of vaccine administered) in a patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. Unknown) for COVID-19 vaccination.     No Medical History information was reported.   On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, 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 INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (inappropriate schedule of vaccine administered). At the time of the report, INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (inappropriate schedule of vaccine administered) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       no medical history was reported no concomitant medication were reported no treatment medication were reported   Reporter did not allow further contact
Age: 40.0
Sex: M
Vaccine: COVID19
Symptoms: Product dose omission issue
Clinical narrative: didn't go get the second one (>36 days between doses); This spontaneous case was reported by a consumer and describes the occurrence of PRODUCT DOSE OMISSION ISSUE (didn't go get the second one (>36 days between doses)) in a 40-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 40518(B)21A) for COVID-19 vaccination.     No Medical History information was reported.    On 27-Apr-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 (didn't go get the second one (>36 days between doses)). At the time of the report, PRODUCT DOSE OMISSION ISSUE (didn't go get the second one (>36 days between doses)) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No concomitant and treatment drugs were reported.
Sex: F
Vaccine: COVID19
Symptoms: Body temperature, Pyrexia
Clinical narrative: This spontaneous case reported by a consumer, describes the occurrence of pyrexia (fever of 100.2ºF) in a female patient, of an unknown age, who received mRNA-1273 (Moderna COVID-19 vaccine) for COVID-19 immunization. No medical history reported. On Aug 5, 2021, patient received the first dose of mRNA-1273 (Moderna COVID-19 vaccine), unknown route; 1 dosage form. On Aug 5, 2021, patient experienced pyrexia (fever of 100.2ºF). At the time of the report, pyrexia (fever of 100.2ºF) outcome: unknown. Diagnostic results: On Aug 5, 2021, body temperature: 100.2°F (high). The action taken with mRNA-1273 (Moderna COVID-19 vaccine): unknown. No concomitant medication or treatment information reported.
Age: 46.0
Sex: F
Vaccine: COVID19
Symptoms: Fatigue, Headache, Influenza like illness, Myalgia, Somnolence
Clinical narrative: almost flu like symptoms; headache/head hurt; tired; Felt achy; Sleepiness; This spontaneous case was reported by a consumer and describes the occurrence of SOMNOLENCE (Sleepiness), INFLUENZA LIKE ILLNESS (almost flu like symptoms), HEADACHE (headache/head hurt), FATIGUE (tired) and MYALGIA (Felt achy) in a 46-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 011A21A and 048A21A) for COVID-19 vaccination.     Concomitant products included LOSARTAN, HYDROCHLOROTHIAZIDE, VENLAFAXINE and PRAVASTATIN for an unknown indication.   On 01-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 29-Mar-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 SOMNOLENCE (Sleepiness), INFLUENZA LIKE ILLNESS (almost flu like symptoms), HEADACHE (headache/head hurt), FATIGUE (tired) and MYALGIA (Felt achy). At the time of the report, SOMNOLENCE (Sleepiness), INFLUENZA LIKE ILLNESS (almost flu like symptoms), HEADACHE (headache/head hurt), FATIGUE (tired) and MYALGIA (Felt achy) had resolved.            No treatment medications were reported.
Age: 65.0
Sex: F
Vaccine: COVID19
Symptoms: Fear of falling, Muscular weakness
Clinical narrative: Weakness in legs and arms/Knees feel like buckling; Afraid she's going to fall anytime; This spontaneous case was reported by a consumer and describes the occurrence of MUSCULAR WEAKNESS (Weakness in legs and arms/Knees feel like buckling) and FEAR OF FALLING (Afraid she's going to fall anytime) in a 65-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 030L20A and 025L20A) for COVID-19 vaccination.     Concurrent medical conditions included Hypertension. Concomitant products included VITAMINS NOS for an unknown indication.   On 31-Dec-2020, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 29-Jan-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. In February 2021, the patient experienced MUSCULAR WEAKNESS (Weakness in legs and arms/Knees feel like buckling) and FEAR OF FALLING (Afraid she's going to fall anytime). At the time of the report, MUSCULAR WEAKNESS (Weakness in legs and arms/Knees feel like buckling) and FEAR OF FALLING (Afraid she's going to fall anytime) had not resolved.            Concomitant medications includes Blood pressure medications and vitamins. No treatment medications were provided.
Age: 49.0
Sex: F
Vaccine: COVID19
Symptoms: Expired product administered
Clinical narrative: Receiving a dose from a vial that was opened more than 12hs before vaccination; This spontaneous case was reported by a health care professional and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Receiving a dose from a vial that was opened more than 12hs before vaccination) in a 49-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 003c21a) for COVID-19 vaccination.     No Medical History information was reported.    On 06-Aug-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 06-Aug-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (Receiving a dose from a vial that was opened more than 12hs before vaccination). At the time of the report, EXPIRED PRODUCT ADMINISTERED (Receiving a dose from a vial that was opened more than 12hs before vaccination) 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.   Unknown medication was taken as concomitant   No treatment medication was provided.
Sex: U
Vaccine: COVID19
Symptoms: Expired product administered
Clinical narrative: 80 doses administered after the 30 day expiration; Based on the current case data, this case has been classified as invalid. This spontaneous case was reported by a physician and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (80 doses administered after the 30 day expiration) 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 EXPIRED PRODUCT ADMINISTERED (80 doses administered after the 30 day expiration). At the time of the report, EXPIRED PRODUCT ADMINISTERED (80 doses administered after the 30 day expiration) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   Two lot number involved: lot number: 022C21A expiry date:  23-Oct-2021 and 035C21A expiry date: 30-Oct-2021, neither have experience an excurtion prior this. No concomitant medications were reported. No treatment information was reported.
Age: 43.0
Sex: M
Vaccine: COVID19
Symptoms: Expired product administered
Clinical narrative: Receiving a dose from a vial that was opened more than 12hs before vaccination; This spontaneous case was reported by an other health care professional and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Receiving a dose from a vial that was opened more than 12hs before vaccination) in a 43-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 003c21a) for COVID-19 vaccination.     No Medical History information was reported.    On 06-Aug-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 06-Aug-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (Receiving a dose from a vial that was opened more than 12hs before vaccination). At the time of the report, EXPIRED PRODUCT ADMINISTERED (Receiving a dose from a vial that was opened more than 12hs before vaccination) 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.   Following vaccination patients showed no symptoms was noted. The reporter stated that the vial was first opened yesterday at 9:20 am. Concomitant was not provided by the reporter. No treatment information was provided by the reporter.
Sex: F
Vaccine: COVID19
Symptoms: Back pain, Bone pain, Muscle spasms
Clinical narrative: cramps; back aches; bone aches; This spontaneous case was reported by a consumer and describes the occurrence of MUSCLE SPASMS (cramps), BACK PAIN (back aches) and BONE PAIN (bone aches) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 040A21A and 070B21) for COVID-19 vaccination.     The patient's past medical history included High risk pregnancy (She had a condition where the placenta separates from the uterus.), Breast cancer stage III (She had breast reconstruction, She was on Chemo and had radiation), Tumor (Tumor in the spine that had to be removed.), Polyps (Polyps in the uterus), Cyst and Breast reconstruction on 10-May-2021. Concomitant products included TAMOXIFEN, GABAPENTIN and TRAZODONE for an unknown indication.   On 30-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 27-Apr-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 MUSCLE SPASMS (cramps), BACK PAIN (back aches) and BONE PAIN (bone aches). At the time of the report, MUSCLE SPASMS (cramps), BACK PAIN (back aches) and BONE PAIN (bone aches) outcome was unknown.            No treatment information was provided.
Age: 61.0
Sex: M
Vaccine: COVID19
Symptoms: Product dose omission issue
Clinical narrative: Patient did not receive the 2nd dose between 25-35 days of receiving the 1st dose/missed his scheduled 2nd dose; This spontaneous case was reported by a pharmacist and describes the occurrence of PRODUCT DOSE OMISSION ISSUE (Patient did not receive the 2nd dose between 25-35 days of receiving the 1st dose/missed his scheduled 2nd dose) in a 61-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 025L210A) for COVID-19 vaccination.     No Medical History information was reported.    On 22-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 PRODUCT DOSE OMISSION ISSUE (Patient did not receive the 2nd dose between 25-35 days of receiving the 1st dose/missed his scheduled 2nd dose). At the time of the report, PRODUCT DOSE OMISSION ISSUE (Patient did not receive the 2nd dose between 25-35 days of receiving the 1st dose/missed his scheduled 2nd dose) 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 information on concomitant medication were reported. It was reported that, the patient missed his scheduled 2nd dose because he works nightshift and the 2nd dose was only offered during the dayshift.
Age: 41.0
Sex: F
Vaccine: COVID19
Symptoms: Fatigue, Vaccination site pain
Clinical narrative: tiredness; sore right injection site arm; This spontaneous case was reported by a nurse and describes the occurrence of FATIGUE (tiredness) and VACCINATION SITE PAIN (sore right injection site arm) in a 41-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    In January 2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. In January 2021, the patient experienced FATIGUE (tiredness) and VACCINATION SITE PAIN (sore right injection site arm). At the time of the report, FATIGUE (tiredness) and VACCINATION SITE PAIN (sore right injection site arm) 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.   Concomitant medication product use was not provided by the reporter. No treatment information was provided.   This case was linked to MOD-2021-279897 (Patient Link).
Sex: F
Vaccine: COVID19
Symptoms: Myalgia, Oropharyngeal pain
Clinical narrative: really bad sore throat; bad body ache; This spontaneous case was reported by a consumer and describes the occurrence of OROPHARYNGEAL PAIN (really bad sore throat) and MYALGIA (bad body ache) 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 31-Jul-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced OROPHARYNGEAL PAIN (really bad sore throat) and MYALGIA (bad body ache). At the time of the report, OROPHARYNGEAL PAIN (really bad sore throat) outcome was unknown and MYALGIA (bad body ache) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Concomitant medications were not reported.  No treatment information was provided by the reporter.
Age: 72.0
Sex: M
Vaccine: COVID19
Symptoms: Fatigue
Clinical narrative: severe fatigue; This spontaneous case was reported by a consumer and describes the occurrence of FATIGUE (severe fatigue) in a 72-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was provided.  Concomitant products included METOPROLOL for an unknown indication.   In February 2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. In March 2021, 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 FATIGUE (severe fatigue). At the time of the report, FATIGUE (severe fatigue) had not resolved.            Concomitant medications included allergy medications, cholestrol medications and GERD medications.  No Treatment information was provided by the reporter.  Patient stated that he was very active person and it was very unusual for him to have this fatigue.
Sex: U
Vaccine: COVID19
Symptoms: Product dose omission issue
Clinical narrative: First shot was 2 months ago; 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 PRODUCT DOSE OMISSION ISSUE (First shot was 2 months ago) 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 (First shot was 2 months ago). At the time of the report, PRODUCT DOSE OMISSION ISSUE (First shot was 2 months ago) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No concomitant medications were reported. No treatment information was provided.   Reporter did not allow further contact
Age: 41.0
Sex: F
Vaccine: COVID19
Symptoms: Fatigue, Vaccination site pain
Clinical narrative: Tiredness; Sore right injection site arm; This spontaneous case was reported by an other health care professional and describes the occurrence of FATIGUE (Tiredness) and VACCINATION SITE PAIN (Sore right injection site arm) in a 41-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.   In January 2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. In February 2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. In February 2021, the patient experienced FATIGUE (Tiredness) and VACCINATION SITE PAIN (Sore right injection site arm). At the time of the report, FATIGUE (Tiredness) and VACCINATION SITE PAIN (Sore right injection site arm) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   No concomitant medication information was provided. No treatment medication were provided.   This case was linked to MOD-2021-279875 (Patient Link).   Reporter did not allow further contact
Age: 61.0
Sex: M
Vaccine: COVID19
Symptoms: Chest discomfort, Dyspnoea
Clinical narrative: hard to get my breath for 3-4 hours/hard to breathe; a concrete block laying on my chest/chest discomfort; This spontaneous case was reported by a consumer and describes the occurrence of DYSPNOEA (hard to get my breath for 3-4 hours/hard to breathe) and CHEST DISCOMFORT (a concrete block laying on my chest/chest discomfort) in a 61-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 053C21A) for COVID-19 vaccination.     No Medical History information was reported.    On 31-Jul-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 31-Jul-2021, the patient experienced DYSPNOEA (hard to get my breath for 3-4 hours/hard to breathe) and CHEST DISCOMFORT (a concrete block laying on my chest/chest discomfort). At the time of the report, DYSPNOEA (hard to get my breath for 3-4 hours/hard to breathe) and CHEST DISCOMFORT (a concrete block laying on my chest/chest discomfort) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No concomitant medications were provided by the reporter  No treatment information  were provided by the reporter
Age: 74.0
Sex: U
Vaccine: COVID19
Symptoms: Fatigue, Hypersensitivity, Pyrexia, Somnolence
Clinical narrative: Difficulty staying awake / Grogginess; severe reaction; extreme fatigue; fever; This spontaneous case was reported by a consumer and describes the occurrence of SOMNOLENCE (Difficulty staying awake / Grogginess), HYPERSENSITIVITY (severe reaction), FATIGUE (extreme fatigue) and PYREXIA (fever) in a 74-year-old patient of an unknown gender who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 034c21a and 026c21a) for COVID-19 vaccination.     Concomitant products included ACETYLSALICYLIC ACID  ASPIRIN) for an unknown indication.   On 08-Jul-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 05-Aug-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 05-Aug-2021, the patient experienced SOMNOLENCE (Difficulty staying awake / Grogginess), HYPERSENSITIVITY (severe reaction), FATIGUE (extreme fatigue) and PYREXIA (fever). At the time of the report, SOMNOLENCE (Difficulty staying awake / Grogginess), HYPERSENSITIVITY (severe reaction), FATIGUE (extreme fatigue) and PYREXIA (fever) outcome was unknown.    Additional concomitant medication use included cholesterol medication for unknown condition.  Treatment information was not provided
Age: 39.0
Sex: M
Vaccine: COVID19
Symptoms: Inappropriate schedule of product administration, Pyrexia
Clinical narrative: Second dose is due for more than 42 days; Fever (it wasn't documented); This spontaneous case was reported by a physician and describes the occurrence of INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Second dose is due for more than 42 days) and PYREXIA (Fever (it wasn't documented)) in an adult male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On 09-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Second dose is due for more than 42 days) and PYREXIA (Fever (it wasn't documented)). At the time of the report, INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Second dose is due for more than 42 days) had resolved and PYREXIA (Fever (it wasn't documented)) 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 relevant concomitant medications were reported.  No treatment information was provided.   Most recent FOLLOW-UP information incorporated above includes: On 27-Sep-2021: Follow up received on 27 Sep 2021 contains no new information.
Age: 34.0
Sex: F
Vaccine: COVID19
Symptoms: Arthralgia, Chills, Myalgia, Peripheral swelling, Vaccination site pain
Clinical narrative: swelling in arm; chills; body ache/body is starting to hurt; joint pain; Vaccination site swelling; Vaccination site pain; This spontaneous case was reported by a consumer and describes the occurrence of PERIPHERAL SWELLING (swelling in arm), CHILLS (chills), MYALGIA (body ache/body is starting to hurt), ARTHRALGIA (joint pain) and VACCINATION SITE SWELLING (Vaccination site swelling) in a 34-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 939902) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.    On 05-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 PERIPHERAL SWELLING (swelling in arm), CHILLS (chills), MYALGIA (body ache/body is starting to hurt), ARTHRALGIA (joint pain), VACCINATION SITE SWELLING (Vaccination site swelling) and VACCINATION SITE PAIN (Vaccination site pain). At the time of the report, PERIPHERAL SWELLING (swelling in arm), CHILLS (chills), MYALGIA (body ache/body is starting to hurt), ARTHRALGIA (joint pain), VACCINATION SITE SWELLING (Vaccination site swelling) and VACCINATION SITE PAIN (Vaccination site pain) outcome was unknown.        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.
Age: 34.0
Sex: F
Vaccine: COVID19
Symptoms: Vaccination site swelling
Clinical narrative: swelling in arm; chills; body ache/body is starting to hurt; joint pain; Vaccination site swelling; Vaccination site pain; This spontaneous case was reported by a consumer and describes the occurrence of PERIPHERAL SWELLING (swelling in arm), CHILLS (chills), MYALGIA (body ache/body is starting to hurt), ARTHRALGIA (joint pain) and VACCINATION SITE SWELLING (Vaccination site swelling) in a 34-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 939902) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.    On 05-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 PERIPHERAL SWELLING (swelling in arm), CHILLS (chills), MYALGIA (body ache/body is starting to hurt), ARTHRALGIA (joint pain), VACCINATION SITE SWELLING (Vaccination site swelling) and VACCINATION SITE PAIN (Vaccination site pain). At the time of the report, PERIPHERAL SWELLING (swelling in arm), CHILLS (chills), MYALGIA (body ache/body is starting to hurt), ARTHRALGIA (joint pain), VACCINATION SITE SWELLING (Vaccination site swelling) and VACCINATION SITE PAIN (Vaccination site pain) outcome was unknown.        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.
Age: 80.0
Sex: F
Vaccine: COVID19
Symptoms: Dyspnoea, Fatigue
Clinical narrative: I began having shortness of breath; Fatigue; This spontaneous case was reported by a consumer and describes the occurrence of DYSPNOEA (I began having shortness of breath) and FATIGUE (Fatigue) 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.   In March 2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced DYSPNOEA (I began having shortness of breath) and FATIGUE (Fatigue). At the time of the report, DYSPNOEA (I began having shortness of breath) and FATIGUE (Fatigue) outcome was unknown.            No information on concomitant medications were reported. No information on treatment medication reported.
Age: 23.0
Sex: F
Vaccine: COVID19
Symptoms: Vaccination site erythema, Vaccination site induration, Vaccination site pain, Vaccination site pruritus
Clinical narrative: Can feel a ball; Area is red where she was vaccinated; Itches; Hurts; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE PRURITUS (Itches), VACCINATION SITE PAIN (Hurts), VACCINATION SITE ERYTHEMA (Area is red where she was vaccinated) and VACCINATION SITE INDURATION (Can feel a ball) in a 23-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On 29-Jul-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 05-Aug-2021, the patient experienced VACCINATION SITE PRURITUS (Itches) and VACCINATION SITE PAIN (Hurts). On 06-Aug-2021, the patient experienced VACCINATION SITE ERYTHEMA (Area is red where she was vaccinated). On an unknown date, the patient experienced VACCINATION SITE INDURATION (Can feel a ball). At the time of the report, VACCINATION SITE PRURITUS (Itches), VACCINATION SITE PAIN (Hurts), VACCINATION SITE ERYTHEMA (Area is red where she was vaccinated) and VACCINATION SITE INDURATION (Can feel a ball) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       The caller was wondering that  if she could give her Benadryl, as It's like a late reaction.  No concomitant medications were reported.  No treatment information was provided by the reporter.
Sex: M
Vaccine: COVID19
Symptoms: Product dose omission issue, SARS-CoV-2 test
Clinical narrative: I received my first shot at the end of January but was unable to get my second; This spontaneous case was reported by a consumer and describes the occurrence of PRODUCT DOSE OMISSION ISSUE (I received my first shot at the end of January but was unable to get my second) 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.    In January 2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. In January 2021, the patient experienced PRODUCT DOSE OMISSION ISSUE (I received my first shot at the end of January but was unable to get my second). In January 2021, PRODUCT DOSE OMISSION ISSUE (I received my first shot at the end of January but was unable to get my second) had resolved.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, SARS-CoV-2 test: negative (Negative) Negative.     The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Concomitant product information was not provided. Treatment information was not provided.   Most recent FOLLOW-UP information incorporated above includes: On 09-Aug-2021: Follow-up information received contains non-significant information.
Age: 47.0
Sex: F
Vaccine: COVID19
Symptoms: Fatigue
Clinical narrative: I was really tired.; This spontaneous case was reported by a consumer and describes the occurrence of FATIGUE (I was really tired.) in a 47-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 078C21A) for COVID-19 vaccination.     No Medical History information was reported.    On 11-Jul-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 11-Jul-2021, the patient experienced FATIGUE (I was really tired.). At the time of the report, FATIGUE (I was really tired.) outcome was unknown. The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown. No Concomitant Medications details were provided.  The  patient  second dose of the Moderna Covid-19 vaccine was due on 08-Aug-2021  No Treatment Medications details were provided.
Sex: F
Vaccine: COVID19
Symptoms: Chills, Myalgia, Pyrexia
Clinical narrative: Fever; Chills; Body aches; This spontaneous case was reported by a consumer and describes the occurrence of PYREXIA (Fever), CHILLS (Chills) and MYALGIA (Body aches) 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 04-Aug-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 05-Aug-2021, the patient experienced PYREXIA (Fever), CHILLS (Chills) and MYALGIA (Body aches). At the time of the report, PYREXIA (Fever), CHILLS (Chills) and MYALGIA (Body aches) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown Route) was unknown.       No concomitant medication reported. No treatment information was provided.
Sex: F
Vaccine: COVID19
Symptoms: Fatigue
Clinical narrative: little tired for a day after the second vaccine; This spontaneous case was reported by a patient and describes the occurrence of FATIGUE (little tired for a day after the second vaccine) 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 an unknown date, the patient experienced FATIGUE (little tired for a day after the second vaccine). At the time of the report, FATIGUE (little tired for a day after the second vaccine) had resolved. Not Provided          No Concomitant medications were reported. No Treatment information was reported.   Reporter did not allow further contact
Age: 59.0
Sex: F
Vaccine: COVID19
Symptoms: Inappropriate schedule of product administration
Clinical narrative: Patient received the second dose too early; This spontaneous case was reported by a pharmacist and describes the occurrence of INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Patient received the second dose too early) in a 59-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 048B21A and 048B21A) for COVID-19 vaccination.     No medical history was reported.  Concomitant products included ISOSORBIDE for an unknown indication.   On 23-Jul-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 06-Aug-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 06-Aug-2021, the patient experienced INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Patient received the second dose too early). On 06-Aug-2021, INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Patient received the second dose too early) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   Treatment information was not provided.   Most recent FOLLOW-UP information incorporated above includes: On 01-Oct-2021: Non-significant Follow-up added to include certified mail returned. Phone Number, Fax Number and e-mail address updated in Reporter Information tab and pregnancy status updated in patient tab.
Sex: U
Vaccine: COVID19
Symptoms: Product dose omission issue
Clinical narrative: I got Moderna vaccine at the end of February. I was too scared to get the second dose; This spontaneous case was reported by a consumer and describes the occurrence of PRODUCT DOSE OMISSION ISSUE (I got Moderna vaccine at the end of February. I was too scared to get the second dose) in a  patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    In February 2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. In February 2021, the patient experienced PRODUCT DOSE OMISSION ISSUE (I got Moderna vaccine at the end of February. I was too scared to get the second dose). In February 2021, PRODUCT DOSE OMISSION ISSUE (I got Moderna vaccine at the end of February. I was too scared to get the second dose) had resolved. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No Concomitant product details were provided by the reporter. No Treatment information was provided.; Sender's Comments: This is a case of a Medication error, dose omission for 2nd dose of Covid 19/mRNA 1273 vaccine. Causality for medication error not applicable.
Sex: U
Vaccine: COVID19
Symptoms: Vaccination complication
Clinical narrative: want to report a vaccine event; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION COMPLICATION (want to report a vaccine event) 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 VACCINATION COMPLICATION (want to report a vaccine event). At the time of the report, VACCINATION COMPLICATION (want to report a vaccine event) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No concomitant medications were reported. No Treatment information was reported.
Age: 54.0
Sex: M
Vaccine: COVID19
Symptoms: Fatigue, Headache, Pain
Clinical narrative: Few hours after the first dose, had a mild headache, tired and little achy; first dose, the patient experienced aches, headache and fatigue.; first dose, the patient experienced aches, headache and fatigue. This spontaneous case was reported by a consumer and describes the occurrence of PAIN (Few hours after the first dose, had a mild headache, tired and little achy), HEADACHE (first dose, the patient experienced aches, headache and fatigue.) and FATIGUE (first dose, the patient experienced aches, headache and fatigue.) in a 54-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 001B21A and 001C21A) for COVID-19 vaccination.     Concomitant products included OMEPRAZOLE, FLUTICASONE, GABAPENTIN, TETRACYCLINE, FINASTERIDE, PSEUDOEPHEDRINE and DIPHENHYDRAMINE HYDROCHLORIDE (BENADRYL [DIPHENHYDRAMINE HYDROCHLORIDE]) for an unknown indication.   On 01-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 29-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 01-Apr-2021, the patient experienced PAIN (Few hours after the first dose, had a mild headache, tired and little achy), HEADACHE (first dose, the patient experienced aches, headache and fatigue.) and FATIGUE (first dose, the patient experienced aches, headache and fatigue.). At the time of the report, PAIN (Few hours after the first dose, had a mild headache, tired and little achy), HEADACHE (first dose, the patient experienced aches, headache and fatigue.) and FATIGUE (first dose, the patient experienced aches, headache and fatigue.) outcome was unknown.            No treatment information were provided.   This case was linked to MOD-2021-280015 (Patient Link).   Most recent FOLLOW-UP information incorporated above includes: On 12-Oct-2021: Follow up received and it contains no new information.
Age: 58.0
Sex: M
Vaccine: COVID19
Symptoms: Abnormal dreams, Insomnia, Sinusitis
Clinical narrative: Vivid dreams multiple times every night; He wakes up many times and is Not being able to sleep right ,he's still waking three or four times a night.; His left sinus keeps getting infected; This spontaneous case was reported by a consumer and describes the occurrence of ABNORMAL DREAMS (Vivid dreams multiple times every night), INSOMNIA (He wakes up many times and is Not being able to sleep right ,he's still waking three or four times a night.) and SINUSITIS (His left sinus keeps getting infected) in a 58-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 042C20A and 022M20A) for COVID-19 vaccination.     Concomitant products included AMLODIPINE for Blood pressure high, LITHIUM for an unknown indication.   On 16-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 13-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient experienced ABNORMAL DREAMS (Vivid dreams multiple times every night), INSOMNIA (He wakes up many times and is Not being able to sleep right ,he's still waking three or four times a night.) and SINUSITIS (His left sinus keeps getting infected). The patient was treated with MELATONIN for Insomnia, at an unspecified dose and frequency. At the time of the report, ABNORMAL DREAMS (Vivid dreams multiple times every night) and SINUSITIS (His left sinus keeps getting infected) outcome was unknown and INSOMNIA (He wakes up many times and is Not being able to sleep right ,he's still waking three or four times a night.) had not resolved.            Reporter did not allow further contact
Sex: M
Vaccine: COVID19
Symptoms: Nausea, Pyrexia
Clinical narrative: feels feverish; nauseous; This spontaneous case was reported by a consumer and describes the occurrence of PYREXIA (feels feverish) and NAUSEA (nauseous) in a male patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. unknown) for COVID-19 vaccination.     No Medical History information was reported.    On 05-Aug-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 06-Aug-2021, the patient experienced PYREXIA (feels feverish) and NAUSEA (nauseous). At the time of the report, PYREXIA (feels feverish) and NAUSEA (nauseous) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No concomitant medication were provided. No treatment details were provided