chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 61.0
Sex: F
Vaccine: COVID19
Symptoms: Headache
Clinical narrative: This spontaneous case was reported by a consumer and describes the occurrence of HEADACHE (Headache) in a 61-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 027C21A and 003C21A) for COVID-19 vaccination. No Medical History information was reported. On 18-May-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 15-Jun-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 15-Jun-2021, the patient experienced HEADACHE (Headache). At the time of the report, HEADACHE (Headache) outcome was unknown. Concomitant product use was not provided by the reporter. Treatment information was not provided.
Sex: U
Vaccine: COVID19
Symptoms: Adverse event
Clinical narrative: Side effects; This spontaneous case was reported by a consumer and describes the occurrence of ADVERSE EVENT (Side effects) 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 ADVERSE EVENT (Side effects). At the time of the report, ADVERSE EVENT (Side effects) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       no concomitant medications reported. no treatment details reported.
Sex: U
Vaccine: COVID19
Symptoms: Musculoskeletal discomfort, Myalgia
Clinical narrative: discomfort in my back; muscle pain; This spontaneous case was reported by a consumer and describes the occurrence of MUSCULOSKELETAL DISCOMFORT (discomfort in my back) and MYALGIA (muscle pain) 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 second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced MUSCULOSKELETAL DISCOMFORT (discomfort in my back) and MYALGIA (muscle pain). At the time of the report, MUSCULOSKELETAL DISCOMFORT (discomfort in my back) and MYALGIA (muscle pain) outcome was unknown.            No concomitant medications were reported.  No laboratory details were  provided.  No treatment medications were reported.  Action taken with mRNA-1273 in response to the events was not applicable.
Sex: U
Vaccine: COVID19
Symptoms: Expired product administered
Clinical narrative: Medical assistant administered expired dose to 1 patient; Based on the current case data, this case has been classified as invalid. This spontaneous case was reported by a nurse and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Medical assistant administered expired dose to 1 patient) in a patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 047C21A) for COVID-19 vaccination.     No Medical History information was reported.    On 16-Jun-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 16-Jun-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (Medical assistant administered expired dose to 1 patient). On 16-Jun-2021, EXPIRED PRODUCT ADMINISTERED (Medical assistant administered expired dose to 1 patient) 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 reported.
Age: 89.0
Sex: F
Vaccine: COVID19
Symptoms: Asthenia, Dyspnoea, Fatigue, Feeling abnormal, Somnolence
Clinical narrative: Brain fogginess; Difficulty in breathing; Patient is very sleepy all the time; Has no energy at all; Tiredness; This spontaneous case was reported by a consumer and describes the occurrence of FEELING ABNORMAL (Brain fogginess), DYSPNOEA (Difficulty in breathing), SOMNOLENCE (Patient is very sleepy all the time), ASTHENIA (Has no energy at all) and FATIGUE (Tiredness) in an 89-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 028A21A. and 032L20A) for COVID-19 vaccination.     The patient's past medical history included Breast cancer female (Breast Cancer left side) and Heparin-induced thrombosis (H/o Heparin Induced Thrombosis and was hospitalized before receiving the vaccination both the doses). Concurrent medical conditions included Thrombosis NOS (Patient developed clot in one kidney and half of the spleen was affected as well because of the clot) and Single functional kidney (Now patient presently surviving with one functioning kidney.). Concomitant products included LOSARTAN and SERTRALINE (SERTA [SERTRALINE]) for an unknown indication.   On 27-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 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 FEELING ABNORMAL (Brain fogginess), DYSPNOEA (Difficulty in breathing), SOMNOLENCE (Patient is very sleepy all the time), ASTHENIA (Has no energy at all) and FATIGUE (Tiredness). At the time of the report, FEELING ABNORMAL (Brain fogginess), SOMNOLENCE (Patient is very sleepy all the time), ASTHENIA (Has no energy at all) and FATIGUE (Tiredness) had not resolved and DYSPNOEA (Difficulty in breathing) outcome was unknown.            The patient post receiving the second dose developed the symptoms of tiredness and still had the problem of brain fogginess and difficulty in breathing. The patient reported that the tiredness and the brain fogginess was still persisting following the 1st shot. At the time of report the patient was very sleepy all the time and had no energy at all.  The patient also reported that they would be visiting the Neurologist in July.  The patient didn't take any treatment for the side effects.   This case was linked to MOD-2021-042756 (Patient Link).
Age: 54.0
Sex: F
Vaccine: COVID19
Symptoms: Contusion, Tenderness, Vaccination site pain
Clinical narrative: bruising on her left arm in 2 places and more "blurish-blue bruising" on right arm; some tenderness; soreness around injection side; This spontaneous case was reported by a consumer and describes the occurrence of CONTUSION (bruising on her left arm in 2 places and more "blurish-blue bruising" on right arm), TENDERNESS (some tenderness) and VACCINATION SITE PAIN (soreness around injection side) in a 54-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 038C21A and 024C21A) for COVID-19 vaccination.     No Medical History information was reported.   On 09-May-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 06-Jun-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form(s). On 13-Jun-2021, the patient experienced CONTUSION (bruising on her left arm in 2 places and more "blurish-blue bruising" on right arm), TENDERNESS (some tenderness) and VACCINATION SITE PAIN (soreness around injection side). At the time of the report, CONTUSION (bruising on her left arm in 2 places and more "blurish-blue bruising" on right arm), TENDERNESS (some tenderness) and VACCINATION SITE PAIN (soreness around injection side) outcome was unknown.            No relevant concomitant medications reported.  No treatment information was provided.  Action taken with mRNA-1273 (Moderna COVID-19 Vaccine) in response to the event was not applicable.
Sex: U
Vaccine: COVID19
Symptoms: Fatigue
Clinical narrative: Long term fatigue; This spontaneous case was reported by a consumer and describes the occurrence of FATIGUE (Long term fatigue) 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 FATIGUE (Long term fatigue). At the time of the report, FATIGUE (Long term fatigue) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No concomitant medications were provided. Treatment medications were unknown.
Age: 85.0
Sex: F
Vaccine: COVID19
Symptoms: Ageusia, Asthenia, Decreased appetite, Dyspnoea, Eating disorder
Clinical narrative: Not received the 2nd dose of the Moderna COVID-19 vaccine yet; temperature of 100.6 F for 3 days; very sick starting April 4th or 5th; shortness of breath; couldn't eat; lost all taste; very, very weak; couldn't eat; This spontaneous case was reported by a consumer and describes the occurrence of ILLNESS (very sick starting April 4th or 5th), DYSPNOEA (shortness of breath), DECREASED APPETITE (couldn't eat), AGEUSIA (lost all taste) and ASTHENIA (very, very weak) in an 85-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 006B21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     The patient's past medical history included COVID-19. Concurrent medical conditions included Cholesterol blood increased. Concomitant products included ESCITALOPRAM OXALATE (LEXAPRO), METOPROLOL and LOSARTAN for an unknown indication.    On 23-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 04-Apr-2021, the patient experienced ILLNESS (very sick starting April 4th or 5th), DYSPNOEA (shortness of breath), DECREASED APPETITE (couldn't eat), AGEUSIA (lost all taste), ASTHENIA (very, very weak), EATING DISORDER (couldn't eat) and PYREXIA (temperature of 100.6 F for 3 days). On an unknown date, the patient experienced PRODUCT DOSE OMISSION ISSUE (Not received the 2nd dose of the Moderna COVID-19 vaccine yet). At the time of the report, ILLNESS (very sick starting April 4th or 5th), DYSPNOEA (shortness of breath), DECREASED APPETITE (couldn't eat), AGEUSIA (lost all taste), ASTHENIA (very, very weak), EATING DISORDER (couldn't eat) and PYREXIA (temperature of 100.6 F for 3 days) outcome was unknown and PRODUCT DOSE OMISSION ISSUE (Not received the 2nd dose of the Moderna COVID-19 vaccine yet) had resolved.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, SARS-CoV-2 test: unknown (Positive) Covid test positive (She tested negative 20 days later).     The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Concomitant medications included an unknown cholesterol medication.  No treatment information was provided.
Age: 85.0
Sex: F
Vaccine: COVID19
Symptoms: Illness, Product dose omission issue, Pyrexia, SARS-CoV-2 test
Clinical narrative: Not received the 2nd dose of the Moderna COVID-19 vaccine yet; temperature of 100.6 F for 3 days; very sick starting April 4th or 5th; shortness of breath; couldn't eat; lost all taste; very, very weak; couldn't eat; This spontaneous case was reported by a consumer and describes the occurrence of ILLNESS (very sick starting April 4th or 5th), DYSPNOEA (shortness of breath), DECREASED APPETITE (couldn't eat), AGEUSIA (lost all taste) and ASTHENIA (very, very weak) in an 85-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 006B21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     The patient's past medical history included COVID-19. Concurrent medical conditions included Cholesterol blood increased. Concomitant products included ESCITALOPRAM OXALATE (LEXAPRO), METOPROLOL and LOSARTAN for an unknown indication.    On 23-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 04-Apr-2021, the patient experienced ILLNESS (very sick starting April 4th or 5th), DYSPNOEA (shortness of breath), DECREASED APPETITE (couldn't eat), AGEUSIA (lost all taste), ASTHENIA (very, very weak), EATING DISORDER (couldn't eat) and PYREXIA (temperature of 100.6 F for 3 days). On an unknown date, the patient experienced PRODUCT DOSE OMISSION ISSUE (Not received the 2nd dose of the Moderna COVID-19 vaccine yet). At the time of the report, ILLNESS (very sick starting April 4th or 5th), DYSPNOEA (shortness of breath), DECREASED APPETITE (couldn't eat), AGEUSIA (lost all taste), ASTHENIA (very, very weak), EATING DISORDER (couldn't eat) and PYREXIA (temperature of 100.6 F for 3 days) outcome was unknown and PRODUCT DOSE OMISSION ISSUE (Not received the 2nd dose of the Moderna COVID-19 vaccine yet) had resolved.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, SARS-CoV-2 test: unknown (Positive) Covid test positive (She tested negative 20 days later).     The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Concomitant medications included an unknown cholesterol medication.  No treatment information was provided.
Age: 56.0
Sex: M
Vaccine: COVID19
Symptoms: Contusion, Hepatic steatosis, Rash
Clinical narrative: Rash on legs; Bruising easily; Fatty liver; This spontaneous case was reported by a consumer and describes the occurrence of RASH (Rash on legs), CONTUSION (Bruising easily) and HEPATIC STEATOSIS (Fatty liver) in a 56-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 024C21A and 03621A) for COVID-19 vaccination.     No medical history was provided by the reporter.  Concomitant products included LEVOTHYROXINE SODIUM (SYNTHROID) for an unknown indication.   On 12-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 10-May-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 10-May-2021, the patient experienced RASH (Rash on legs), CONTUSION (Bruising easily) and HEPATIC STEATOSIS (Fatty liver). At the time of the report, RASH (Rash on legs), CONTUSION (Bruising easily) and HEPATIC STEATOSIS (Fatty liver) outcome was unknown.            Concomitant medication information not provided.  Treatment information not provided.  Action taken with mRNA-1273 in response to the event/s was not applicable.
Age: 59.0
Sex: F
Vaccine: COVID19
Symptoms: Intentional product use issue
Clinical narrative: Is it too late to get a second shot after three months; This spontaneous case was reported by a consumer and describes the occurrence of INTENTIONAL PRODUCT USE ISSUE (Is it too late to get a second shot after three months) in a 59-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced INTENTIONAL PRODUCT USE ISSUE (Is it too late to get a second shot after three months). At the time of the report, INTENTIONAL PRODUCT USE ISSUE (Is it too late to get a second shot after three months) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       Patient received the first dose of vaccine three months ago and has been out of country since then.  Concomitant medications were not reported.  No treatment information was provided.
Age: 78.0
Sex: F
Vaccine: COVID19
Symptoms: Pain, Pain in extremity, Therapeutic response unexpected
Clinical narrative: feel like workout/arm hurt; feeling achy in their entire body; Therapeutic response unexpected; This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (feel like workout/arm hurt), PAIN (feeling achy in their entire body) and THERAPEUTIC RESPONSE UNEXPECTED (Therapeutic response unexpected) in a 78-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 002A21A and 007M20N) for COVID-19 vaccination.     Concurrent medical conditions included Hiatal hernia. Concomitant products included LANSOPRAZOLE for Hiatal hernia, HYDROCHLOROTHIAZIDE for Hypertension.   On 27-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 24-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 24-Feb-2021, the patient experienced PAIN IN EXTREMITY (feel like workout/arm hurt) and PAIN (feeling achy in their entire body). 24-Feb-2021, the patient experienced THERAPEUTIC RESPONSE UNEXPECTED (Therapeutic response unexpected). On 25-Feb-2021, PAIN IN EXTREMITY (feel like workout/arm hurt) and PAIN (feeling achy in their entire body) had resolved. At the time of the report, THERAPEUTIC RESPONSE UNEXPECTED (Therapeutic response unexpected) had resolved.            Action taken with mRNA-1273 in response to the events was not applicable. No treatment medication details was reported.   This case was linked to MOD-2021-017758 (Patient Link).
Sex: U
Vaccine: COVID19
Symptoms: Chills, Dyspnoea, Pyrexia
Clinical narrative: chills in my body; a fever; a short breath; This spontaneous case was reported by a consumer and describes the occurrence of CHILLS (chills in my body), PYREXIA (a fever) and DYSPNOEA (a short breath) 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 CHILLS (chills in my body), PYREXIA (a fever) and DYSPNOEA (a short breath). At the time of the report, CHILLS (chills in my body), PYREXIA (a fever) and DYSPNOEA (a short breath) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.
Sex: U
Vaccine: COVID19
Symptoms: Lymphadenopathy, Swelling
Clinical narrative: underneath my underarm on the side in which I was injected with this vaccine it has been swollen an has a not underneath my skin; swollen in my goin area; This spontaneous case was reported by a consumer and describes the occurrence of LYMPHADENOPATHY (underneath my underarm on the side in which I was injected with this vaccine it has been swollen an has a not underneath my skin) and SWELLING (swollen in my goin area) 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 LYMPHADENOPATHY (underneath my underarm on the side in which I was injected with this vaccine it has been swollen an has a not underneath my skin) and SWELLING (swollen in my goin area). At the time of the report, LYMPHADENOPATHY (underneath my underarm on the side in which I was injected with this vaccine it has been swollen an has a not underneath my skin) and SWELLING (swollen in my goin area) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       The concomitant medications were not provided. The Treatment information was not provided.
Age: 74.0
Sex: F
Vaccine: COVID19
Symptoms: Ageusia, Dry mouth, Dysgeusia
Clinical narrative: bitter taste; dry mouth; lost my sense of taste; This spontaneous case was reported by a consumer and describes the occurrence of AGEUSIA (lost my sense of taste), DYSGEUSIA (bitter taste) and DRY MOUTH (dry mouth) in a 74-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 028W2W and 025A21A) for COVID-19 vaccination.     Concurrent medical conditions included Drug allergy (allergic to benedryl), Penicillin allergy, Hypertension since 2004, Depression (mild) since 1996, Macular degeneration since 2018, Restless leg syndrome since 2002, Arthritis since 2017, Insomnia since 2008, Prediabetes since 2004 and Allergic reaction to analgesics (Allergic to codeine). Concomitant products included ASCORBIC ACID, BETACAROTENE, CUPRIC OXIDE, TOCOPHERYL ACETATE, ZINC OXIDE (PRESERVISION) from 2019 to an unknown date for Age-related macular degeneration, CELECOXIB (CELEBREX) from 2020 to an unknown date for Arthritis, SERTRALINE HYDROCHLORIDE (ZOLOFT) from 2004 to an unknown date for Depression, BENAZEPRIL from 2004 to an unknown date for Hypertension, ROPINIROLE HYDROCHLORIDE (ROPINOL) from 2019 to an unknown date for Restless leg syndrome.   On 02-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 30-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 01-Apr-2021,  after starting mRNA-1273 (Moderna COVID-19 Vaccine), the patient experienced AGEUSIA (lost my sense of taste). On an unknown date, the patient experienced DYSGEUSIA (bitter taste) and DRY MOUTH (dry mouth). At the time of the report, AGEUSIA (lost my sense of taste), DYSGEUSIA (bitter taste) and DRY MOUTH (dry mouth) had not resolved.            No treatment information was reported. Patient started chewing a lot of gum and keeping mints.   Most recent FOLLOW-UP information incorporated above includes: On 05-Aug-2021: significant follow-up. Medical history added and start dates updated.Start dates of concomitant medications updated. Ageusis, event start date and causality were updated. Dry mouth was added as an event.
Sex: U
Vaccine: COVID19
Symptoms: Adverse reaction
Clinical narrative: This spontaneous case was reported by an other and describes the occurrence of ADVERSE REACTION (Patient said yes when asked if had experienced a side effect but did not provide further information.) 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 ADVERSE REACTION (Patient said yes when asked if had experienced a side effect but did not provide further information.). At the time of the report, ADVERSE REACTION (Patient said yes when asked if had experienced a side effect but did not provide further information.) outcome was unknown. The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.
Sex: U
Vaccine: COVID19
Symptoms: Vaccination complication
Clinical narrative: bad symptoms 6 days after 2nd vaccine; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION COMPLICATION (bad symptoms 6 days after 2nd 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 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 VACCINATION COMPLICATION (bad symptoms 6 days after 2nd vaccine). At the time of the report, VACCINATION COMPLICATION (bad symptoms 6 days after 2nd vaccine) outcome was unknown.            Action taken with vaccine was not applicable.  No concomitant medication was reported.  No treatment information was provided.
Age: 59.0
Sex: M
Vaccine: COVID19
Symptoms: Tinnitus
Clinical narrative: ringing of the ears/tinnitus/he would give it a 12 (on a scale of 1 to 10)/It's gotten really really loud and raging/it's gotten worse; This spontaneous case was reported by a consumer and describes the occurrence of TINNITUS (ringing of the ears/tinnitus/he would give it a 12 (on a scale of 1 to 10)/It's gotten really really loud and raging/it's gotten worse) in a 59-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 008B21-2A and 046B21A) for COVID-19 vaccination.     No Medical History information was reported.   On 24-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 21-Apr-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 TINNITUS (ringing of the ears/tinnitus/he would give it a 12 (on a scale of 1 to 10)/It's gotten really really loud and raging/it's gotten worse). At the time of the report, TINNITUS (ringing of the ears/tinnitus/he would give it a 12 (on a scale of 1 to 10)/It's gotten really really loud and raging/it's gotten worse) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   Concomitant product use was not provided by the reporter.   ? No treatment information was provided.   Most recent FOLLOW-UP information incorporated above includes: On 28-Jul-2021: Follow up received containing Non significant information
Age: 33.0
Sex: M
Vaccine: COVID19
Symptoms: Blood test, Confusional state, Feeling abnormal, Migraine, Neck pain
Clinical narrative: Neck pain.; I felt a heartbeat in my head & neck; Have recurring migraines; Confusion/ My mind itself, it's moving/ I feel like my brain is moving.; This spontaneous case was reported by a consumer and describes the occurrence of FEELING ABNORMAL (I felt a heartbeat in my head & neck), MIGRAINE (Have recurring migraines), CONFUSIONAL STATE (Confusion/ My mind itself, it's moving/ I feel like my brain is moving.) and NECK PAIN (Neck pain.) in a 33-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     The patient's past medical history included Neck pain (Patient had neck problems back in 2020.). Concurrent medical conditions included Deaf.   On 23-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 20-May-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 20-May-2021, the patient experienced FEELING ABNORMAL (I felt a heartbeat in my head & neck), MIGRAINE (Have recurring migraines) and CONFUSIONAL STATE (Confusion/ My mind itself, it's moving/ I feel like my brain is moving.). On an unknown date, the patient experienced NECK PAIN (Neck pain.). The patient was treated with IBUPROFEN (ADVIL [IBUPROFEN]) for Neck pain, at an unspecified dose and frequency. At the time of the report, FEELING ABNORMAL (I felt a heartbeat in my head & neck), MIGRAINE (Have recurring migraines) and CONFUSIONAL STATE (Confusion/ My mind itself, it's moving/ I feel like my brain is moving.) outcome was unknown and NECK PAIN (Neck pain.) had resolved.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, Blood test: normal (normal) Everything was fine and stable..         Concomitant product use was not provided by the reporter.   Most recent FOLLOW-UP information incorporated above includes: On 05-Aug-2021: It was reported that she misreported her adverse events, and it was a misunderstanding. She has not been sick since those events previously. Hence "I felt kinda sick" event was deleted.
Sex: U
Vaccine: COVID19
Symptoms: Vomiting
Clinical narrative: Vomiting; This spontaneous case was reported by a consumer and describes the occurrence of VOMITING (Vomiting) in a patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No medical history 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). At the time of the report, VOMITING (Vomiting) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       Concomitant medications were not reported  No laboratory data was provided.   No treatment information was provided.; Sender's Comments: Based on the current available information a causal relationship cannot be excluded.
Sex: U
Vaccine: COVID19
Symptoms: Malaise
Clinical narrative: Don't feel good at all; 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 MALAISE (Don't feel good at all) 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 MALAISE (Don't feel good at all). At the time of the report, MALAISE (Don't feel good at all) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       Concomitant medications were not reported  No treatment information was provided.
Sex: U
Vaccine: COVID19
Symptoms: Erythema, Vaccination site warmth
Clinical narrative: This spontaneous case was reported by a consumer and describes the occurrence of ERYTHEMA (It's red) and VACCINATION SITE WARMTH (Arm is warm where I got the shot,warm touch) 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 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 ERYTHEMA (It's red) and VACCINATION SITE WARMTH (Arm is warm where I got the shot,warm touch). At the time of the report, ERYTHEMA (It's red) and VACCINATION SITE WARMTH (Arm is warm where I got the shot,warm touch) outcome was unknown. No concomitant medication was reported. No treatment information was reported.
Sex: U
Vaccine: COVID19
Symptoms: Vaccination site pain
Clinical narrative: still have pain at the injection site; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE PAIN (still have pain at the injection site) 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 15-Jun-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 VACCINATION SITE PAIN (still have pain at the injection site). At the time of the report, VACCINATION SITE PAIN (still have pain at the injection site) had not resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No concomitant medications reported. No treatment information was provided.
Age: 50.0
Sex: M
Vaccine: COVID19
Symptoms: Body temperature, Chills, Nausea, Pyrexia, SARS-CoV-2 test
Clinical narrative: Fever; Chills and Shivering; Nausea; This spontaneous case was reported by a health care professional and describes the occurrence of PYREXIA (Fever), CHILLS (Chills and Shivering) and NAUSEA (Nausea) in a 50-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 046A21A) for COVID-19 vaccination.     The patient's past medical history included COVID-19 on 24-Nov-2020.    On 18-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 19-Mar-2021, the patient experienced PYREXIA (Fever), CHILLS (Chills and Shivering) and NAUSEA (Nausea). On 26-Mar-2021, PYREXIA (Fever), CHILLS (Chills and Shivering) and NAUSEA (Nausea) had resolved. Not Provided    DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 19-Mar-2021, Body temperature: 102 (High) High. On 24-Nov-2021, SARS-CoV-2 test: positive (Positive) Positive.     The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   Concomitant product use was not provided by the reporter.   ?No treatment information was provided.
Sex: U
Vaccine: COVID19
Symptoms: Arthralgia, Headache, Neck pain, Pain in extremity
Clinical narrative: This spontaneous case reported by a consumer, describes the occurrence of neck pain (pain in left-side of neck), pain in extremity (pain in arm), headache (sharp pain on the left-side of head) and arthralgia (pain in shoulder) in a patient, of an unknown age and gender, who received mRNA-1273 (Moderna COVID-19 vaccine) for COVID-19 immunization. No medical history reported. On an unknown date, patient received the first dose of mRNA-1273 (Moderna COVID-19 vaccine), unknown route; 1 dosage form. On an unknown date, patient experienced neck pain (pain in left-side of neck), pain in extremity (pain in arm), headache (sharp pain on the left-side of head) and arthralgia (pain in shoulder). At the time of the report, neck pain (pain in left-side of neck), pain in extremity (pain in arm), headache (sharp pain on the left-side of head) and arthralgia (pain in shoulder) outcome: unknown. The action taken with mRNA-1273 (Moderna COVID-19 vaccine): unknown. Concomitant product use and treatment information not provided.
Age: 42.0
Sex: M
Vaccine: COVID19
Symptoms: Myalgia, Nausea, Vaccination site pain
Clinical narrative: This spontaneous case reported by a consumer, describes the occurrence of vaccination site pain (pain around the injection site), nausea and myalgia (soreness) in a 42-year-old male patient who received mRNA-1273 (Moderna COVID-19 vaccine, batch# 037B21A) for COVID-19 immunization. No medical history reported. On Jun 14, 2021, patient received the first dose of mRNA-1273 (Moderna COVID-19 vaccine), unknown route; 1 dosage form. On Jun 14, 2021, patient experienced vaccination site pain (pain around the injection site), nausea and myalgia (soreness). At the time of the report, vaccination site pain (pain around the injection site), nausea and myalgia (soreness) resolved. The action taken with mRNA-1273 (Moderna COVID-19 vaccine): unknown. Concomitant product use and treatment information not provided.
Age: 26.0
Sex: M
Vaccine: COVID19
Symptoms: Throat irritation
Clinical narrative: Itching throat; This spontaneous case was reported by a consumer and describes the occurrence of THROAT IRRITATION (Itching throat) in a 26-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     Concurrent medical conditions included Allergy to molds.    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 THROAT IRRITATION (Itching throat). At the time of the report, THROAT IRRITATION (Itching throat) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No concomitant medications were provided. No treatment details were provided.
Age: 64.0
Sex: F
Vaccine: COVID19
Symptoms: Body temperature, Dyspnoea, Headache, Myalgia, Pain in jaw
Clinical narrative: My head is hurting so bad; My body is aching; My jaw hurts; I am having difficulty breathing; yesterday my temperature was 99.9/today it is 101.9 (101.9 degree F)/it keeps rising/fever; This spontaneous case was reported by a non-health professional and describes the occurrence of PYREXIA (yesterday my temperature was 99.9/today it is 101.9 (101.9 degree F)/it keeps rising/fever), HEADACHE (My head is hurting so bad), MYALGIA (My body is aching), PAIN IN JAW (My jaw hurts) and DYSPNOEA (I am having difficulty breathing) in a 64-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 0034C21A) for COVID-19 vaccination.     No Medical History information was reported.    On 15-Jun-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 15-Jun-2021, the patient experienced PYREXIA (yesterday my temperature was 99.9/today it is 101.9 (101.9 degree F)/it keeps rising/fever). On 16-Jun-2021, the patient experienced HEADACHE (My head is hurting so bad), MYALGIA (My body is aching), PAIN IN JAW (My jaw hurts) and DYSPNOEA (I am having difficulty breathing). The patient was treated with ALBUTEROL SULFATE (tracheal) for Breathing difficult, at a dose of 1 dosage form; VITAMIN D3 (oral) for Pyrexia, at a dose of 1 dosage form; SAMBUCUS NIGRA FRUIT (ELDERBERRY [SAMBUCUS NIGRA FRUIT]) (oral) for Pyrexia, at a dose of 1 dosage form and ZINC for Fever, at a dose of 1 dosage form. At the time of the report, PYREXIA (yesterday my temperature was 99.9/today it is 101.9 (101.9 degree F)/it keeps rising/fever), HEADACHE (My head is hurting so bad), MYALGIA (My body is aching), PAIN IN JAW (My jaw hurts) and DYSPNOEA (I am having difficulty breathing) had not resolved.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 15-Jun-2021, Body temperature (97.7-99.5): 99.9 degree fahrenheit (High) yesterday my temperature was 99.9. On 16-Jun-2021, Body temperature (97.7-99.5): 101.9 degree fahrenheit (High) today it is 101.9.     The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   No concomitant medication provided.  Treatment medication included albuterol inhaler, vitamin D3, elderberry syrup, zinc.
Age: 64.0
Sex: F
Vaccine: COVID19
Symptoms: Pyrexia
Clinical narrative: My head is hurting so bad; My body is aching; My jaw hurts; I am having difficulty breathing; yesterday my temperature was 99.9/today it is 101.9 (101.9 degree F)/it keeps rising/fever; This spontaneous case was reported by a non-health professional and describes the occurrence of PYREXIA (yesterday my temperature was 99.9/today it is 101.9 (101.9 degree F)/it keeps rising/fever), HEADACHE (My head is hurting so bad), MYALGIA (My body is aching), PAIN IN JAW (My jaw hurts) and DYSPNOEA (I am having difficulty breathing) in a 64-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 0034C21A) for COVID-19 vaccination.     No Medical History information was reported.    On 15-Jun-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 15-Jun-2021, the patient experienced PYREXIA (yesterday my temperature was 99.9/today it is 101.9 (101.9 degree F)/it keeps rising/fever). On 16-Jun-2021, the patient experienced HEADACHE (My head is hurting so bad), MYALGIA (My body is aching), PAIN IN JAW (My jaw hurts) and DYSPNOEA (I am having difficulty breathing). The patient was treated with ALBUTEROL SULFATE (tracheal) for Breathing difficult, at a dose of 1 dosage form; VITAMIN D3 (oral) for Pyrexia, at a dose of 1 dosage form; SAMBUCUS NIGRA FRUIT (ELDERBERRY [SAMBUCUS NIGRA FRUIT]) (oral) for Pyrexia, at a dose of 1 dosage form and ZINC for Fever, at a dose of 1 dosage form. At the time of the report, PYREXIA (yesterday my temperature was 99.9/today it is 101.9 (101.9 degree F)/it keeps rising/fever), HEADACHE (My head is hurting so bad), MYALGIA (My body is aching), PAIN IN JAW (My jaw hurts) and DYSPNOEA (I am having difficulty breathing) had not resolved.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 15-Jun-2021, Body temperature (97.7-99.5): 99.9 degree fahrenheit (High) yesterday my temperature was 99.9. On 16-Jun-2021, Body temperature (97.7-99.5): 101.9 degree fahrenheit (High) today it is 101.9.     The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   No concomitant medication provided.  Treatment medication included albuterol inhaler, vitamin D3, elderberry syrup, zinc.
Sex: F
Vaccine: COVID19
Symptoms: Vaccination complication
Clinical narrative: Daughter is still having a bad reaction to her first Moderna shot.; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION COMPLICATION (Daughter is still having a bad reaction to her first Moderna shot.) 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) (unknown route) 1 dosage form. On an unknown date, the patient experienced VACCINATION COMPLICATION (Daughter is still having a bad reaction to her first Moderna shot.). At the time of the report, VACCINATION COMPLICATION (Daughter is still having a bad reaction to her first Moderna shot.) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No concomitant medication was reported. Treatment medication was not provided.
Age: 58.0
Sex: M
Vaccine: COVID19
Symptoms: Product dose omission issue
Clinical narrative: Second dose not administered in allowed time; This spontaneous case was reported by a pharmacist and describes the occurrence of PRODUCT DOSE OMISSION ISSUE (Second dose not administered in allowed time) in a 58-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 006C21A) for COVID-19 vaccination.     No Medical History information was reported.    On 23-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 PRODUCT DOSE OMISSION ISSUE (Second dose not administered in allowed time). At the time of the report, PRODUCT DOSE OMISSION ISSUE (Second dose not administered in allowed time) 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.   It was reported that the patient did not experience any side effects after he received the first dose of vaccine. However, the patient had poor health status prior to vaccination with the first dose and was in hospital for unrelated" reasons during vaccination process, as described by the pharmacist. As a result, the patient missed her second dose appointment.  Concomitant medication and treatment drug were not reported.  Company Comment: This report refers to a case of product dose omission issue for the second dose of mRNA-1273 with no associated AEs reported after the first dose. There is no supportive information to assess the case as serious at this point.   This case was linked to MOD-2021-111911, MOD-2021-111912, MOD-2021-111913 (Patient Link).; Sender's Comments: This report refers to a case of product dose omission issue for the second dose of mRNA-1273 with no associated AEs reported after the first dose. There is no supportive information to assess the case as serious at this point.
Sex: U
Vaccine: COVID19
Symptoms: Rash
Clinical narrative: rash on my body; This spontaneous case was reported by a patient and describes the occurrence of RASH (rash on my body) 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 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 RASH (rash on my body). The patient was treated with LORATADINE, PSEUDOEPHEDRINE HYDROCHLORIDE (BENADRYL 24 D) ongoing since an unknown date at an unspecified dose and frequency and HYDROCORTISONE (CORTIZONE 10) ongoing since an unknown date at an unspecified dose and frequency. At the time of the report, RASH (rash on my body) outcome was unknown.
Sex: U
Vaccine: COVID19
Symptoms: Dizziness
Clinical narrative: lightheaded after vaccination; 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 DIZZINESS (lightheaded after vaccination) 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 DIZZINESS (lightheaded after vaccination). At the time of the report, DIZZINESS (lightheaded after vaccination) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No concomitant medication were reported. No treatment information was reported
Sex: F
Vaccine: COVID19
Symptoms: Rash erythematous
Clinical narrative: Red rash on arm; This spontaneous case was reported by a consumer and describes the occurrence of RASH ERYTHEMATOUS (Red rash on arm) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. unknown) for COVID-19 vaccination.     The patient's past medical history included No adverse event.   On 24-Feb-2021, the patient 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 received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced RASH ERYTHEMATOUS (Red rash on arm). At the time of the report, RASH ERYTHEMATOUS (Red rash on arm) outcome was unknown.            Concomitant medication was not reported. No treatment medication was provided. Patient called to report a possible adverse event. She called on 03-Mar-2021 and got her first vaccine on 24-Feb-2021. She had red rash on her arm. She didn't state when she had her second dose of the Moderna vaccine but she also had a red rash on her arm with the second dose. She was suppose to get a form to fill out from one of our representative but never did. Before the call was connected the patient disconnected the line.   This case was linked to MOD-2021-020916 (Patient Link).
Sex: F
Vaccine: COVID19
Symptoms: Urticaria
Clinical narrative: Looks like hives; This spontaneous case was reported by a consumer and describes the occurrence of URTICARIA (Looks like hives) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No medical history was provided by the reporter.     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 URTICARIA (Looks like hives). At the time of the report, URTICARIA (Looks like hives) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No relevant concomitant medications were reported.  No treatment information was provided.