chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 13.0
Sex: U
Vaccine: COVID19
Symptoms: Product administered to patient of inappropriate age
Clinical narrative: Two 13 year olds received their first Moderna dose; This spontaneous case was reported by a health care professional and describes the occurrence of PRODUCT ADMINISTERED TO PATIENT OF INAPPROPRIATE AGE (Two 13 year olds received their first Moderna dose) in a 13-year-old patient of an unknown gender who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On 03-Jul-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 03-Jul-2021, the patient experienced PRODUCT ADMINISTERED TO PATIENT OF INAPPROPRIATE AGE (Two 13 year olds received their first Moderna dose). On 03-Jul-2021, PRODUCT ADMINISTERED TO PATIENT OF INAPPROPRIATE AGE (Two 13 year olds received their first Moderna dose) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   This reports includes 2 patients. Concomitant product information was not provided. Treatment information was not provided.
Age: 33.0
Sex: F
Vaccine: COVID19
Symptoms: Asthenia, Dizziness, Headache, Musculoskeletal chest pain
Clinical narrative: pain on her left rib , pain on her ribs; weakness; dizziness; headaches; This spontaneous case was reported by a patient and describes the occurrence of MUSCULOSKELETAL CHEST PAIN (pain on her left rib , pain on her ribs), ASTHENIA (weakness), DIZZINESS (dizziness) and HEADACHE (headaches) in a 32-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 053c21a and 047c21a) for COVID-19 vaccination.     No medical history and concomitant drug information was provided by the reporter.    On 07-Jun-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 05-Jul-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 06-Jul-2021, the patient experienced MUSCULOSKELETAL CHEST PAIN (pain on her left rib , pain on her ribs), ASTHENIA (weakness), DIZZINESS (dizziness) and HEADACHE (headaches). At the time of the report, MUSCULOSKELETAL CHEST PAIN (pain on her left rib , pain on her ribs), ASTHENIA (weakness), DIZZINESS (dizziness) and HEADACHE (headaches) had not resolved.            No concomitant medications were reported. No treatment medications were provided.    Most recent FOLLOW-UP information incorporated above includes: On 13-Jul-2021: Follow up received on 13-JUL-2021 contains no significant information.
Age: 84.0
Sex: F
Vaccine: COVID19
Symptoms: Hip fracture, Loss of consciousness
Clinical narrative: Passed out again; Patient broke her left hip; passed out; This spontaneous case was reported by a consumer and describes the occurrence of LOSS OF CONSCIOUSNESS (passed out), LOSS OF CONSCIOUSNESS (Passed out again) and HIP FRACTURE (Patient broke her left hip) in an 84-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 011A21A and 044H21H) for COVID-19 vaccination.     No Medical History information was reported.   On 24-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 24-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 08-Jun-2021, the patient experienced LOSS OF CONSCIOUSNESS (Passed out again) and HIP FRACTURE (Patient broke her left hip). In 2021, the patient experienced LOSS OF CONSCIOUSNESS (passed out). At the time of the report, LOSS OF CONSCIOUSNESS (passed out), LOSS OF CONSCIOUSNESS (Passed out again) and HIP FRACTURE (Patient broke her left hip) outcome was unknown.            In the last part of April or early May 2021, patient passed out and fell to the ground. On 08JUN2021, she passed out again, fell and broke her left hip. She was doing therapy now.  No concomitant medications were reported. No laboratory details were provided. No treatment medications were reported.  Very limited information regarding these events have been provided at this time. No further information is expected. Considering patient's advance age, no medical history provided and no clear temporal associotion between the reported events and vaccination casual relationship between the events and vaccine are considered unlikely related at this point in time.   Most recent FOLLOW-UP information incorporated above includes: On 07-Jul-2021: Live follow-up received contain no new information. Sender's Comments: Very limited information regarding these events have been provided at this time. No further information is expected. Considering patient's advance age, no medical history provided and no clear temporal associotion between the reported events and vaccination casual relationship between the events and vaccine are considered unlikely related at this point in time.
Sex: U
Vaccine: COVID19
Symptoms: Product storage error, Product temperature excursion issue
Clinical narrative: This spontaneous case was reported by an other health care professional and describes the occurrence of PRODUCT STORAGE ERROR (Administered vaccine that went through repeated excursion in the freezer, at various dates) and PRODUCT TEMPERATURE EXCURSION ISSUE (Administered vaccine that went through repeated excursion in the freezer, at various dates) in a patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 053C21A) for COVID-19 vaccination. No Medical History information was reported. In 2021, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. In 2021, the patient experienced PRODUCT STORAGE ERROR (Administered vaccine that went through repeated excursion in the freezer, at various dates) and PRODUCT TEMPERATURE EXCURSION ISSUE (Administered vaccine that went through repeated excursion in the freezer, at various dates). In 2021, PRODUCT STORAGE ERROR (Administered vaccine that went through repeated excursion in the freezer, at various dates) and PRODUCT TEMPERATURE EXCURSION ISSUE (Administered vaccine that went through repeated excursion in the freezer, at various dates) outcome was unknown. The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown. For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments. No concomitant and no treatment medication were informed. Most recent FOLLOW-UP information incorporated above includes: On 07-Jul-2021: Follow up received on 09-JUL-2021, contains non - significant information.
Age: 24.0
Sex: F
Vaccine: COVID19
Symptoms: Body temperature, Exposure via breast milk, Myalgia, Pyrexia
Clinical narrative: myalgia; Fever; Vaccine exposure via breast milk; This spontaneous case was reported by a consumer and describes the occurrence of EXPOSURE VIA BREAST MILK (Vaccine exposure via breast milk), MYALGIA (myalgia) and PYREXIA ( Fever) in a 24-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 053C21A) for COVID-19 vaccination.     Concurrent medical conditions included Maternal exposure during breast feeding. Concomitant products included MINERALS NOS, VITAMINS NOS (PRENATAL VITAMINS [MINERALS NOS;VITAMINS NOS]) for an unknown indication.    On 06-Jul-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 06-Jul-2021, the patient experienced EXPOSURE VIA BREAST MILK (Vaccine exposure via breast milk). On 07-Jul-2021, the patient experienced MYALGIA (myalgia) and PYREXIA ( Fever). On 06-Jul-2021, EXPOSURE VIA BREAST MILK (Vaccine exposure via breast milk) had resolved. At the time of the report, MYALGIA (myalgia) and PYREXIA ( Fever) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 07-Jul-2021, Body temperature: 101.3 (abnormal) 101.3F.     The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Treatment details were not provided.   This case was linked to MOD-2021-250376 (Patient Link).
Age: 78.0
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, Inappropriate schedule of product administration, SARS-CoV-2 test
Clinical narrative: COVID-19 infection after vaccination with 1st shot; Delayed second shot; This spontaneous case was reported by a consumer and describes the occurrence of COVID-19 (COVID-19 infection after vaccination with 1st shot) and INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Delayed second shot) in a 78-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 031M20A and 017B21A) for COVID-19 vaccination.     No Medical History information was reported.   On 03-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 09-Jun-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 09-Jun-2021, the patient experienced INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Delayed second shot). On an unknown date, the patient experienced COVID-19 (COVID-19 infection after vaccination with 1st shot). On 09-Jun-2021, INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Delayed second shot) had resolved. At the time of the report, COVID-19 (COVID-19 infection after vaccination with 1st shot) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, SARS-CoV-2 test: positive (Positive) Positive.         Concomitant medications included water pill, vitamins and blood pressure pill.   Most recent FOLLOW-UP information incorporated above includes: On 23-Sep-2021: Reporter email address updated.; Sender's Comments: This is a case of inappropriate schedule of product administration for this 78-year-old, female patient with no disclosed medical history, who experienced the unexpected event of Covid-19. The date of occurrence of Covid 19 after the first dose of Moderna vaccine is unknown. The rechallenge was negative as patient did not report any new AEs on follow up after the second dose. The benefit-risk relationship of Moderna vaccine is not affected by this report.
Sex: F
Vaccine: COVID19
Symptoms: Feeling hot, Headache, Myalgia, Oral herpes
Clinical narrative: body unnaturally warm; fever blisters around her mouth; muscle ache; headache; This spontaneous case was reported by a consumer and describes the occurrence of FEELING HOT (body unnaturally warm), ORAL HERPES (fever blisters around her mouth), MYALGIA (muscle ache) and HEADACHE (headache) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced FEELING HOT (body unnaturally warm), ORAL HERPES (fever blisters around her mouth), MYALGIA (muscle ache) and HEADACHE (headache). At the time of the report, FEELING HOT (body unnaturally warm), ORAL HERPES (fever blisters around her mouth), MYALGIA (muscle ache) and HEADACHE (headache) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Concomitant medications details were not reported by the reporter. Treatment details was not reported by the reporter.
Age: 35.0
Sex: M
Vaccine: COVID19
Symptoms: Feeling abnormal, Hypotension, Prostatitis, Urine flow decreased
Clinical narrative: Urine flow is depleted, started 24 hours after receiving the vaccine, About 2 weeks and nothing has changed; Feels like a little kid; Very low pressure; Like some sort of prostate issue; This spontaneous case was reported by a consumer and describes the occurrence of URINE FLOW DECREASED (Urine flow is depleted, started 24 hours after receiving the vaccine, About 2 weeks and nothing has changed), FEELING ABNORMAL (Feels like a little kid), HYPOTENSION (Very low pressure) and PROSTATITIS (Like some sort of prostate issue) in a 35-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 035C21A) for COVID-19 vaccination.     No medical history was provided by the reporter.  The patient's past medical history included Accident (Car accident) in 2012, Broken nose in 2012, Broken jaw in 2012, Rib fracture in 2012, Anterior cruciate ligament tear in 2012 and Facial operation in 2012. Concurrent medical conditions included Traumatic brain injury (Cleft skull) since 2012. Concomitant products included PROPRANOLOL, PHENYTOIN and RISPERIDONE for Brain injury.    On 22-Jun-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 23-Jun-2021, the patient experienced URINE FLOW DECREASED (Urine flow is depleted, started 24 hours after receiving the vaccine, About 2 weeks and nothing has changed), FEELING ABNORMAL (Feels like a little kid), HYPOTENSION (Very low pressure) and PROSTATITIS (Like some sort of prostate issue). At the time of the report, URINE FLOW DECREASED (Urine flow is depleted, started 24 hours after receiving the vaccine, About 2 weeks and nothing has changed) had not resolved and FEELING ABNORMAL (Feels like a little kid), HYPOTENSION (Very low pressure) and PROSTATITIS (Like some sort of prostate issue) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       It was reported that patient was scheduled for his second dose on 20-Jul-2021. No treatment medication was reported. patient states does not want to have to start using a catheter
Age: 56.0
Sex: F
Vaccine: COVID19
Symptoms: Vaccination site pain
Clinical narrative: Left deltoid sorness; This spontaneous case was reported by an other health care professional and describes the occurrence of VACCINATION SITE PAIN (Left deltoid sorness) in a 56-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 025J20-2A) for COVID-19 vaccination.     No medical history information was reported.  Concomitant products included MULTIVITAMINS [VITAMINS NOS] and IBUPROFEN for an unknown indication.    On 06-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 06-Jan-2021, the patient experienced VACCINATION SITE PAIN (Left deltoid sorness). At the time of the report, VACCINATION SITE PAIN (Left deltoid sorness) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   No treatment medications were reported   This case was linked to MOD-2021-201340 (Patient Link).
Age: 71.0
Sex: M
Vaccine: COVID19
Symptoms: Expired product administered, Product storage error
Clinical narrative: This spontaneous case was reported by an other health care professional and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Patient received vaccine after allowed expiry time) and PRODUCT STORAGE ERROR (Punctured vial was stored at room temperature for over 12 hours) in a 71-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 078C21A and 017C21A) for COVID-19 vaccination. No Medical History information was reported. On 09-Jun-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 07-Jul-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 07-Jul-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (Patient received vaccine after allowed expiry time) and PRODUCT STORAGE ERROR (Punctured vial was stored at room temperature for over 12 hours). On 07-Jul-2021, EXPIRED PRODUCT ADMINISTERED (Patient received vaccine after allowed expiry time) and PRODUCT STORAGE ERROR (Punctured vial was stored at room temperature for over 12 hours) had resolved. For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments. Concomitant medication was not provided. Treatment information was not provided. Action taken with mRNA-1273 (Moderna COVID-19 Vaccine) in response to the event was not applicable. Most recent FOLLOW-UP information incorporated above includes: On 03-Sep-2021: Follow-up received added Race and Ethnicity information. On 03-Sep-2021: Follow-up received include no new information. On 03-Sep-2021: Follow-up received include no new information.
Sex: U
Vaccine: COVID19
Symptoms: Herpes zoster
Clinical narrative: shingles; 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 HERPES ZOSTER (shingles) in a patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     The patient's past medical history included Graves' disease.    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 HERPES ZOSTER (shingles). At the time of the report, HERPES ZOSTER (shingles) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No concomitant medications were not provided. No treatment medications were not provided.
Sex: M
Vaccine: COVID19
Symptoms: Inappropriate schedule of product administration
Clinical narrative: >35 days after 1st dose; This spontaneous case was reported by a pharmacist and describes the occurrence of INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (>35 days after 1st dose) 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 INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (>35 days after 1st dose). At the time of the report, INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (>35 days after 1st dose) 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 concomitant medications were reported. No treatment medications were provided.
Age: 60.0
Sex: F
Vaccine: COVID19
Symptoms: Abdominal discomfort, Agitation, Erythema, Feeling abnormal, Headache
Clinical narrative: Two red blotched on my chest; felt i was run down and catching something; sore arm; red spots on differet body locations; Her sister knows a bunch people who got vaccinated with Moderna that experienced vertigo; became agitated; felt my lips tingle but did not want to make a fuss; I felt sivk to stomach; headache; vomiting; This spontaneous case was reported by a consumer and describes the occurrence of VERTIGO (Her sister knows a bunch people who got vaccinated with Moderna that experienced vertigo), AGITATION (became agitated), PARAESTHESIA ORAL (felt my lips tingle but did not want to make a fuss), ABDOMINAL DISCOMFORT (I felt sivk to stomacha) and FEELING ABNORMAL (felt i was run down and catching something) in a 60-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 038B21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     The patient's past medical history included Celiac disease (diagnosed around 1995. Diet controls this completely) on 14-Feb-1961. Concurrent medical conditions included Migraine (Migraines started at age 10 Life long suffering) since 14-Feb-1971 and Allergy (unspecified). Concomitant products included DIAZEPAM (VALIUM) from 01-Jan-1998 to an unknown date for Panic attack, FLUOXETINE HYDROCHLORIDE (PROZAC) from 01-Jan-1998 to an unknown date and ESTRADIOL (VAGIFEM) from 01-Jan-2011 to an unknown date for an unknown indication.    On 23-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 23-Apr-2021, the patient experienced AGITATION (became agitated), PARAESTHESIA ORAL (felt my lips tingle but did not want to make a fuss), ABDOMINAL DISCOMFORT (I felt sivk to stomacha), HEADACHE (headache) and VOMITING (vomiting). On an unknown date, the patient experienced VERTIGO (Her sister knows a bunch people who got vaccinated with Moderna that experienced vertigo), FEELING ABNORMAL (felt i was run down and catching something), PAIN IN EXTREMITY (sore arm), ERYTHEMA (red spots on different body locations) and RASH MACULAR (Two red blotched on my chest). On 12-May-2021, PARAESTHESIA ORAL (felt my lips tingle but did not want to make a fuss) had resolved. At the time of the report, VERTIGO (Her sister knows a bunch people who got vaccinated with Moderna that experienced vertigo), AGITATION (became agitated), ABDOMINAL DISCOMFORT (I felt sivk to stomacha), FEELING ABNORMAL (felt i was run down and catching something), PAIN IN EXTREMITY (sore arm), ERYTHEMA (red spots on differebt body locations), RASH MACULAR (Two red blotched on my chest), HEADACHE (headache) and VOMITING (vomiting) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       Treatment information was not provided.   Most recent FOLLOW-UP information incorporated above includes: On 26-Jul-2021: Follow up received- Patient's demographics, MH, suspect drug dose details, concomitant medications and additional events were added.
Age: 60.0
Sex: F
Vaccine: COVID19
Symptoms: Pain in extremity, Paraesthesia oral, Rash macular, Vertigo, Vomiting
Clinical narrative: Two red blotched on my chest; felt i was run down and catching something; sore arm; red spots on differet body locations; Her sister knows a bunch people who got vaccinated with Moderna that experienced vertigo; became agitated; felt my lips tingle but did not want to make a fuss; I felt sivk to stomach; headache; vomiting; This spontaneous case was reported by a consumer and describes the occurrence of VERTIGO (Her sister knows a bunch people who got vaccinated with Moderna that experienced vertigo), AGITATION (became agitated), PARAESTHESIA ORAL (felt my lips tingle but did not want to make a fuss), ABDOMINAL DISCOMFORT (I felt sivk to stomacha) and FEELING ABNORMAL (felt i was run down and catching something) in a 60-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 038B21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     The patient's past medical history included Celiac disease (diagnosed around 1995. Diet controls this completely) on 14-Feb-1961. Concurrent medical conditions included Migraine (Migraines started at age 10 Life long suffering) since 14-Feb-1971 and Allergy (unspecified). Concomitant products included DIAZEPAM (VALIUM) from 01-Jan-1998 to an unknown date for Panic attack, FLUOXETINE HYDROCHLORIDE (PROZAC) from 01-Jan-1998 to an unknown date and ESTRADIOL (VAGIFEM) from 01-Jan-2011 to an unknown date for an unknown indication.    On 23-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 23-Apr-2021, the patient experienced AGITATION (became agitated), PARAESTHESIA ORAL (felt my lips tingle but did not want to make a fuss), ABDOMINAL DISCOMFORT (I felt sivk to stomacha), HEADACHE (headache) and VOMITING (vomiting). On an unknown date, the patient experienced VERTIGO (Her sister knows a bunch people who got vaccinated with Moderna that experienced vertigo), FEELING ABNORMAL (felt i was run down and catching something), PAIN IN EXTREMITY (sore arm), ERYTHEMA (red spots on different body locations) and RASH MACULAR (Two red blotched on my chest). On 12-May-2021, PARAESTHESIA ORAL (felt my lips tingle but did not want to make a fuss) had resolved. At the time of the report, VERTIGO (Her sister knows a bunch people who got vaccinated with Moderna that experienced vertigo), AGITATION (became agitated), ABDOMINAL DISCOMFORT (I felt sivk to stomacha), FEELING ABNORMAL (felt i was run down and catching something), PAIN IN EXTREMITY (sore arm), ERYTHEMA (red spots on differebt body locations), RASH MACULAR (Two red blotched on my chest), HEADACHE (headache) and VOMITING (vomiting) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       Treatment information was not provided.   Most recent FOLLOW-UP information incorporated above includes: On 26-Jul-2021: Follow up received- Patient's demographics, MH, suspect drug dose details, concomitant medications and additional events were added.
Age: 54.0
Sex: M
Vaccine: COVID19
Symptoms: Product dose omission issue
Clinical narrative: No Second dose administered 47 days after the First dose; This spontaneous case was reported by a pharmacist and describes the occurrence of PRODUCT DOSE OMISSION ISSUE (No Second dose administered 47 days after the First dose) in a 54-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 035C21A) for COVID-19 vaccination.     No Medical History information was reported.    On 21-May-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 21-May-2021, the patient experienced PRODUCT DOSE OMISSION ISSUE (No Second dose administered 47 days after the First dose). At the time of the report, PRODUCT DOSE OMISSION ISSUE (No Second dose administered 47 days after the First dose) 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.   Patient was not sick after the first vaccine.   Concomitant medication not provided.  Treatment information not provided.
Sex: U
Vaccine: COVID19
Symptoms: Dizziness, Swelling face, Vomiting
Clinical narrative: vomiting; dizziness; face swelling; This spontaneous case was reported by a consumer and describes the occurrence of VOMITING (vomiting), DIZZINESS (dizziness) and SWELLING FACE (face swelling) 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 VOMITING (vomiting), DIZZINESS (dizziness) and SWELLING FACE (face swelling). At the time of the report, VOMITING (vomiting), DIZZINESS (dizziness) and SWELLING FACE (face swelling) outcome was unknown.            No relevant concomitant medication was reported.  No treatment medication was reported.
Sex: F
Vaccine: COVID19
Symptoms: Dizziness
Clinical narrative: felt lightheaded; This spontaneous case was reported by a patient and describes the occurrence of DIZZINESS (felt lightheaded) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On an unknown date, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced DIZZINESS (felt lightheaded). At the time of the report, DIZZINESS (felt lightheaded) outcome was unknown.            Concomitant information was not provided. Treatment information was not provided.
Age: 54.0
Sex: F
Vaccine: COVID19
Symptoms: Asthenia, COVID-19, Dizziness, Ear pain, Headache
Clinical narrative: This spontaneous case was reported by a consumer and describes the occurrence of PERIPHERAL SWELLING (repeated arm swelling), ASTHENIA (Weakness), DIZZINESS (Dizziness), EAR PAIN (Ear pain) and PRURITUS (itching) in a 54-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 043B21A and 033C21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below. The patient's past medical history included Broken bones (survived  a massive car accident in February 2021, from which she has several bones broken) in February 2021 and Blood transfusion (Received Blood transfusion). Concurrent medical conditions included HIV disease (very long term HIV survivor (since age of 17) was reported). Concomitant products included BUPROPION for Antidepressant drug level therapeutic, HYDROXYZINE HYDROCHLORIDE (HYDROXYZINE [HYDROXYZINE HYDROCHLORIDE]) for Anxiety, LITHIUM CARBONATE for Bipolar disorder, BICTEGRAVIR SODIUM, EMTRICITABINE, TENOFOVIR ALAFENAMIDE FUMARATE (BIKTARVY) for HIV infection, CLONAZEPAM for Insomnia and Anxiety, GABAPENTIN and GABAPENTIN (GRALISE) for Nerve pain, OXYCODONE for Pain, DABIGATRAN ETEXILATE MESILATE (PRADAXA) and COLECALCIFEROL (VITAMIN D [COLECALCIFEROL]) for an unknown indication. On 14-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 15-May-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 PERIPHERAL SWELLING (repeated arm swelling), ASTHENIA (Weakness), DIZZINESS (Dizziness), EAR PAIN (Ear pain), PRURITUS (itching), COVID-19 (Tested positive for Covid-19 last week/ER doctor thinks it's the Delta variant), ILLNESS (Have been really sick), HEADACHE (Headache) and VACCINATION SITE ERYTHEMA (Two red spots in left arm where injections where given). The patient was treated with GUAIFENESIN (MUCINEX) for Headache and Ear ache, at a dose of UNK, q6h. At the time of the report, PERIPHERAL SWELLING (repeated arm swelling), ASTHENIA (Weakness), DIZZINESS (Dizziness), EAR PAIN (Ear pain), PRURITUS (itching), COVID-19 (Tested positive for Covid-19 last week/ER doctor thinks it's the Delta variant), ILLNESS (Have been really sick), HEADACHE (Headache) and VACCINATION SITE ERYTHEMA (Two red spots in left arm where injections where given) outcome was unknown. DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, SARS-CoV-2 test: positive (Positive) Positive, Delta variant. Patient reported that tested positive for COVID-19 and her doctor thought that it was the Delta variant. Most recent FOLLOW-UP information incorporated above includes: On 21-Jul-2021: Follow up information received and contains significant information. Email address added. Lab data added. New events Sickness and COVID-19 added.
Age: 54.0
Sex: F
Vaccine: COVID19
Symptoms: Illness, Peripheral swelling, Pruritus, SARS-CoV-2 test, Vaccination site erythema
Clinical narrative: This spontaneous case was reported by a consumer and describes the occurrence of PERIPHERAL SWELLING (repeated arm swelling), ASTHENIA (Weakness), DIZZINESS (Dizziness), EAR PAIN (Ear pain) and PRURITUS (itching) in a 54-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 043B21A and 033C21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below. The patient's past medical history included Broken bones (survived  a massive car accident in February 2021, from which she has several bones broken) in February 2021 and Blood transfusion (Received Blood transfusion). Concurrent medical conditions included HIV disease (very long term HIV survivor (since age of 17) was reported). Concomitant products included BUPROPION for Antidepressant drug level therapeutic, HYDROXYZINE HYDROCHLORIDE (HYDROXYZINE [HYDROXYZINE HYDROCHLORIDE]) for Anxiety, LITHIUM CARBONATE for Bipolar disorder, BICTEGRAVIR SODIUM, EMTRICITABINE, TENOFOVIR ALAFENAMIDE FUMARATE (BIKTARVY) for HIV infection, CLONAZEPAM for Insomnia and Anxiety, GABAPENTIN and GABAPENTIN (GRALISE) for Nerve pain, OXYCODONE for Pain, DABIGATRAN ETEXILATE MESILATE (PRADAXA) and COLECALCIFEROL (VITAMIN D [COLECALCIFEROL]) for an unknown indication. On 14-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 15-May-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 PERIPHERAL SWELLING (repeated arm swelling), ASTHENIA (Weakness), DIZZINESS (Dizziness), EAR PAIN (Ear pain), PRURITUS (itching), COVID-19 (Tested positive for Covid-19 last week/ER doctor thinks it's the Delta variant), ILLNESS (Have been really sick), HEADACHE (Headache) and VACCINATION SITE ERYTHEMA (Two red spots in left arm where injections where given). The patient was treated with GUAIFENESIN (MUCINEX) for Headache and Ear ache, at a dose of UNK, q6h. At the time of the report, PERIPHERAL SWELLING (repeated arm swelling), ASTHENIA (Weakness), DIZZINESS (Dizziness), EAR PAIN (Ear pain), PRURITUS (itching), COVID-19 (Tested positive for Covid-19 last week/ER doctor thinks it's the Delta variant), ILLNESS (Have been really sick), HEADACHE (Headache) and VACCINATION SITE ERYTHEMA (Two red spots in left arm where injections where given) outcome was unknown. DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, SARS-CoV-2 test: positive (Positive) Positive, Delta variant. Patient reported that tested positive for COVID-19 and her doctor thought that it was the Delta variant. Most recent FOLLOW-UP information incorporated above includes: On 21-Jul-2021: Follow up information received and contains significant information. Email address added. Lab data added. New events Sickness and COVID-19 added.
Age: 67.0
Sex: F
Vaccine: COVID19
Symptoms: Chest discomfort, Product dose omission issue
Clinical narrative: Loud bang in chest 45 minutes after shot; First dose >35 days ago; This spontaneous case was reported by a consumer and describes the occurrence of CHEST DISCOMFORT (Loud bang in chest 45 minutes after shot) and PRODUCT DOSE OMISSION ISSUE (First dose >35 days ago) in a 67-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 029L20A) for COVID-19 vaccination.     No Medical History information was reported.    On 12-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 12-Jan-2021, the patient experienced CHEST DISCOMFORT (Loud bang in chest 45 minutes after shot) and PRODUCT DOSE OMISSION ISSUE (First dose >35 days ago). At the time of the report, CHEST DISCOMFORT (Loud bang in chest 45 minutes after shot) and PRODUCT DOSE OMISSION ISSUE (First dose >35 days ago) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Concomitant medications were not provided.  Treatment information was not provided.
Age: 45.0
Sex: F
Vaccine: COVID19
Symptoms: Asthma exercise induced, Dyspnoea, Fatigue
Clinical narrative: extreme shortness of breath; possible exercise induced asthma; fatigue; This spontaneous case was reported by a consumer and describes the occurrence of DYSPNOEA (extreme shortness of breath), ASTHMA EXERCISE INDUCED (possible exercise induced asthma) and FATIGUE (fatigue) in a 45-year-old female adult exposed to mRNA-1273 (Moderna COVID-19 Vaccine) , while the parent received the product for COVID-19 vaccination.     No Medical History information was reported.   On an unknown date, the parent 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. Last menstrual period and estimated date of delivery were not provided. On an unknown date, the adult was diagnosed with DYSPNOEA (extreme shortness of breath), ASTHMA EXERCISE INDUCED (possible exercise induced asthma) and FATIGUE (fatigue). The Adult was exposed to mRNA-1273 (Moderna COVID-19 Vaccine) during pregnancy.  The adult was treated with ALBUTEROL [SALBUTAMOL] at an unspecified dose and frequency. At the time of the report, DYSPNOEA (extreme shortness of breath), ASTHMA EXERCISE INDUCED (possible exercise induced asthma) and FATIGUE (fatigue) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant medications were reported.
Age: 23.0
Sex: M
Vaccine: COVID19
Symptoms: Expired product administered, Product storage error
Clinical narrative: Punctured vial was stored at room temperature for over 12 hours; Patient received vaccine after allowed expiry time; This spontaneous case was reported by a pharmacist and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Patient received vaccine after allowed expiry time) and PRODUCT STORAGE ERROR (Punctured vial was stored at room temperature for over 12 hours) in a 23-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 078C21A and 051C21A) for COVID-19 vaccination.     No Medical History information was reported.   On 12-Jun-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 07-Jul-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 07-Jul-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (Patient received vaccine after allowed expiry time). On an unknown date, the patient experienced PRODUCT STORAGE ERROR (Punctured vial was stored at room temperature for over 12 hours). At the time of the report, EXPIRED PRODUCT ADMINISTERED (Patient received vaccine after allowed expiry time) and PRODUCT STORAGE ERROR (Punctured vial was stored at room temperature for over 12 hours) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   No relevant concomitant medication was reported. No treatment medication was reported.
Age: 78.0
Sex: F
Vaccine: COVID19
Symptoms: Vaccination site erythema, Vaccination site pruritus, Vaccination site rash
Clinical narrative: red rash  at injection site; injection site itchy; injection site bright red; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE PRURITUS (injection site itchy), VACCINATION SITE ERYTHEMA (injection site bright red) and VACCINATION SITE RASH (red rash  at injection site) in a 78-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 06-Jul-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 07-Jul-2021, the patient experienced VACCINATION SITE PRURITUS (injection site itchy) and VACCINATION SITE ERYTHEMA (injection site bright red). On an unknown date, the patient experienced VACCINATION SITE RASH (red rash  at injection site). At the time of the report, VACCINATION SITE PRURITUS (injection site itchy), VACCINATION SITE ERYTHEMA (injection site bright red) and VACCINATION SITE RASH (red rash  at injection site) 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 concomitant medications were reported. No treatment information was provided.   Most recent FOLLOW-UP information incorporated above includes: On 07-Jul-2021: Additional  information includes address and event (very red rash) were added. On 26-Jul-2021: Non-significant follow-up appended.
Age: 40.0
Sex: M
Vaccine: COVID19
Symptoms: Expired product administered, Product storage error
Clinical narrative: Punctured vial was stored at room temperature for over 12 hours; Patient received vaccine after allowed expiry time; This spontaneous case was reported by a pharmacist (subsequently medically confirmed) and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Patient received vaccine after allowed expiry time) and PRODUCT STORAGE ERROR (Punctured vial was stored at room temperature for over 12 hours) in a 40-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 078C21A and 017C21A) for COVID-19 vaccination.     No Medical History information was reported.   On 09-Jun-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 07-Jul-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 07-Jul-2021,  after starting mRNA-1273 (Moderna COVID-19 Vaccine), the patient experienced EXPIRED PRODUCT ADMINISTERED (Patient received vaccine after allowed expiry time). On an unknown date, the patient experienced PRODUCT STORAGE ERROR (Punctured vial was stored at room temperature for over 12 hours). At the time of the report, EXPIRED PRODUCT ADMINISTERED (Patient received vaccine after allowed expiry time) and PRODUCT STORAGE ERROR (Punctured vial was stored at room temperature for over 12 hours) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   No concomitant product use was provided by the reporter.  No treatment medication was provided.  The patient received the second dose which was left at room temperature for over 12 hours. The vial was left at room temperature from the day before. The vial was removed from the fridge 06-JUL-2021 around 09:45/ 10:00 am, punctured at 10:15 am and administered on 7-jul-2021 at 09:35/09:45.  The action taken with mRNA-1273 in response to the events were not applicable.
Age: 48.0
Sex: M
Vaccine: COVID19
Symptoms: Alopecia
Clinical narrative: This spontaneous case was reported by a consumer (subsequently medically confirmed) and describes the occurrence of ALOPECIA (Got a bald spot on his head/different bald spots all over his body/All of his hair is falling off including the hair on his arm, eyebrows, and head/When he puts on his glasses, his hair will be falling off) in a 48-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 016B21A and 016B21A) for COVID-19 vaccination. No Medical History information was reported. On 17-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 15-May-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 ALOPECIA (Got a bald spot on his head/different bald spots all over his body/All of his hair is falling off including the hair on his arm, eyebrows, and head/When he puts on his glasses, his hair will be falling off). At the time of the report, ALOPECIA (Got a bald spot on his head/different bald spots all over his body/All of his hair is falling off including the hair on his arm, eyebrows, and head/When he puts on his glasses, his hair will be falling off) outcome was unknown. No concomitant medications reported. Treatment information included natural herbs and a bottle of vitamins/natural remedy for skin and hair that was recommended by patient's doctor.
Sex: U
Vaccine: COVID19
Symptoms: Chills, Headache
Clinical narrative: headache after 1st dose; chills after 1st dose; This spontaneous case was reported by a consumer and describes the occurrence of HEADACHE (headache after 1st dose) and CHILLS (chills after 1st 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.    On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced HEADACHE (headache after 1st dose) and CHILLS (chills after 1st dose). The patient was treated with PARACETAMOL (TYLENOL) for Headache, at an unspecified dose and frequency. At the time of the report, HEADACHE (headache after 1st dose) and CHILLS (chills after 1st dose) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No concomitant medications were provided.   This case was linked to MOD-2021-028922 (Patient Link).
Age: 76.0
Sex: M
Vaccine: COVID19
Symptoms: Mouth ulceration, Oral pain
Clinical narrative: This spontaneous case reported by a consumer, describes the occurrence of mouth ulceration (mouth ulcers) and oral pain (soreness in the mouth) in a 77-year-old male patient who received mRNA-1273 (Moderna COVID-19 vaccine, batch/lot# 036A21A) for COVID-19 immunization. Concurrent medical conditions included hypertension, cholesterosis and rheumatoid arthritis. On Mar 5, 2021, patient received the first dose of mRNA-1273 (Moderna COVID-19 vaccine), intramuscular; 1 dosage form. On Mar 5, 2021, patient experienced mouth ulceration (mouth ulcers) and oral pain (soreness in the mouth). At the time of the report, mouth ulceration (mouth ulcers) and oral pain (soreness in the mouth) outcome: unknown. Treatment information included Magic mouth wash. Patient received the 2nd dose of Moderna vaccine, left arm, on Apr 2, 2021. (batch/lot# 037A21A).
Sex: U
Vaccine: COVID19
Symptoms: Myalgia
Clinical narrative: Arm pain since receiving Moderna vaccine; This spontaneous case was reported by a consumer and describes the occurrence of MYALGIA (Arm pain since receiving Moderna vaccine) 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-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 MYALGIA (Arm pain since receiving Moderna vaccine). At the time of the report, MYALGIA (Arm pain since receiving Moderna vaccine) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       no concomitant medications are provided. treatment to the events not reported.   Reporter did not allow further contact
Sex: M
Vaccine: COVID19
Symptoms: Sleep disorder, Tinnitus
Clinical narrative: wasn't sleeping; tinnitus; This spontaneous case was reported by a consumer and describes the occurrence of SLEEP DISORDER (wasn't sleeping) and TINNITUS (tinnitus) 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 dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced SLEEP DISORDER (wasn't sleeping) and TINNITUS (tinnitus). At the time of the report, SLEEP DISORDER (wasn't sleeping) and 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 provided.
Sex: U
Vaccine: COVID19
Symptoms: Pyrexia
Clinical narrative: Low grade fever for 22 days; This spontaneous case was reported by a consumer and describes the occurrence of PYREXIA (Low grade fever for 22 days) 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 PYREXIA (Low grade fever for 22 days). At the time of the report, PYREXIA (Low grade fever for 22 days) outcome was unknown. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No concomitant medications were provided.  No treatment medications were provided.