chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 44.0
Sex: U
Vaccine: COVID19
Symptoms: Temporomandibular joint syndrome
Clinical narrative: TMJ in is jaw; This spontaneous case was reported by a consumer and describes the occurrence of TEMPOROMANDIBULAR JOINT SYNDROME (TMJ in is jaw) in a 44-year-old patient of an unknown gender who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 001A21A and 001A21A) for COVID-19 vaccination.     Concomitant products included ESCITALOPRAM OXALATE (LEXAPRO) for Anxiety, LORAZEPAM for an unknown indication.   On 22-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 22-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient experienced TEMPOROMANDIBULAR JOINT SYNDROME (TMJ in is jaw). At the time of the report, TEMPOROMANDIBULAR JOINT SYNDROME (TMJ in is jaw) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   Patient reported being in between healthcare providers and that patient had seen a neurologist. Patient consent to follow up with safety team. Patient consent to follow up with neurologist.  Action taken with mRNA-1273 (COVID 19 Vaccine Moderna) was not applicable. No concomitant product reported by reporter. No treatment medication reported by reporter.   This case was linked to MOD-2021-234496 (Patient Link).
Age: 28.0
Sex: F
Vaccine: COVID19
Symptoms: Acne, Blood immunoglobulin G
Clinical narrative: Zits got infected/ tiny cuts and zits are getting infected which didn't normally happen; This spontaneous case was reported by a consumer and describes the occurrence of ACNE (Zits got infected/ tiny cuts and zits are getting infected which didn't normally happen) in a 28-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 022C21A) for COVID-19 vaccination.     No Medical History information was reported.  Concomitant products included ZIPRASIDONE HYDROCHLORIDE (GEODON [ZIPRASIDONE HYDROCHLORIDE]), VENLAFAXINE HYDROCHLORIDE (EFFEXOR), LORAZEPAM (ATIVAN) and VITAMIN D [VITAMIN D NOS] for an unknown indication.    On 11-May-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. In May 2021, the patient experienced ACNE (Zits got infected/ tiny cuts and zits are getting infected which didn't normally happen). At the time of the report, ACNE (Zits got infected/ tiny cuts and zits are getting infected which didn't normally happen) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): In 2021, Blood immunoglobulin G: igg subclass were low (Inconclusive) IgG subclass were low.     The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Reportedly, about two weeks after getting first dose of vaccine, one of her zits got infected. She noticed that her tiny cuts and zits were getting infected which didn't normally happen. She went to the doctor who told her to use a triple antibiotic ointment which helped but there were still scars. About 4-5 weeks ago she got labs done and they noticed her IgG subclass were low.
Age: 49.0
Sex: F
Vaccine: COVID19
Symptoms: Myalgia
Clinical narrative: typical soreness on arm; This spontaneous case was reported by a consumer and describes the occurrence of MYALGIA (typical soreness on arm) in a 49-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 022B21A) for COVID-19 vaccination.     No Medical History information was reported.    On 25-May-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 25-May-2021, the patient experienced MYALGIA (typical soreness on arm). At the time of the report, MYALGIA (typical soreness on arm) had resolved. Not provided.      mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosing remained unchanged.       No concomitant medications reported.   Treatment information not reported.   This case was linked to MOD-2021-234576 (Patient Link).   Most recent FOLLOW-UP information incorporated above includes: On 19-Jul-2021: Follow up received and outcome of the event updated.
Sex: U
Vaccine: COVID19
Symptoms: Palpitations
Clinical narrative: heart palpitations; This spontaneous case was reported by a consumer and describes the occurrence of PALPITATIONS (heart palpitations) 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) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced PALPITATIONS (heart palpitations). At the time of the report, PALPITATIONS (heart palpitations) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No concomitant medication was reported. Treatment medication was not provided.
Sex: U
Vaccine: COVID19
Symptoms: Hypoaesthesia
Clinical narrative: hand numbness; This spontaneous case was reported by a consumer and describes the occurrence of HYPOAESTHESIA (hand numbness) 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 HYPOAESTHESIA (hand numbness). At the time of the report, HYPOAESTHESIA (hand numbness) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No concomitant medication were provided. No treatment information was provided.
Age: 73.0
Sex: F
Vaccine: COVID19
Symptoms: Vaccination site erythema, Vaccination site mass, Vaccination site rash
Clinical narrative: Injection site had bumps; A few red spots around the injection site/a large red spot around the injection site; A few red spots around the injection site/a large red spot around the injection site; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE MASS (Injection site had bumps), VACCINATION SITE ERYTHEMA (A few red spots around the injection site/a large red spot around the injection site) and VACCINATION SITE RASH (A few red spots around the injection site/a large red spot around the injection site) in a 73-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 049C21A) for COVID-19 vaccination.     No Medical History information was reported.    On 14-Jun-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 22-Jun-2021, the patient experienced VACCINATION SITE ERYTHEMA (A few red spots around the injection site/a large red spot around the injection site) and VACCINATION SITE RASH (A few red spots around the injection site/a large red spot around the injection site). On 24-Jun-2021, the patient experienced VACCINATION SITE MASS (Injection site had bumps). At the time of the report, VACCINATION SITE MASS (Injection site had bumps), VACCINATION SITE ERYTHEMA (A few red spots around the injection site/a large red spot around the injection site) and VACCINATION SITE RASH (A few red spots around the injection site/a large red spot around the injection site) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No concomitant medication were reported. No treatment information was reported
Age: 20.0
Sex: F
Vaccine: COVID19
Symptoms: Product dose omission issue
Clinical narrative: Second dose not received in allowed timeframe; This spontaneous case was reported by a consumer and describes the occurrence of PRODUCT DOSE OMISSION ISSUE (Second dose not received in allowed timeframe) in a 21-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 033C21A) for COVID-19 vaccination.     No medical history was provided by the reporter.  Concomitant products included ORAL CONTRACEPTIVE NOS for an unknown indication.    On 11-May-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 received in allowed timeframe). At the time of the report, PRODUCT DOSE OMISSION ISSUE (Second dose not received in allowed timeframe) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No Concomitant medication were reported.  No treatment medication were reported.
Age: 49.0
Sex: F
Vaccine: COVID19
Symptoms: Burning sensation, Chills, Myalgia, Pain, Pyrexia
Clinical narrative: red mark like a bruise on the vaccination site; vaccination site warm to the touch; vaccination site is still red; vaccination site puffy; Body ache; chills; fever; burning; stinging; pain at vaccination site during the injection; This spontaneous case was reported by a consumer and describes the occurrence of BURNING SENSATION (burning), PAIN (stinging), VACCINATION SITE BRUISING (red mark like a bruise on the vaccination site), VACCINATION SITE WARMTH (vaccination site warm to the touch) and VACCINATION SITE ERYTHEMA (vaccination site is still red) in a 49-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 050C21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.   On 22-Jun-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 22-Jun-2021, the patient experienced BURNING SENSATION (burning), PAIN (stinging), VACCINATION SITE PAIN (pain at vaccination site during the injection) and PYREXIA (fever). On 23-Jun-2021, the patient experienced VACCINATION SITE BRUISING (red mark like a bruise on the vaccination site), VACCINATION SITE WARMTH (vaccination site warm to the touch), VACCINATION SITE ERYTHEMA (vaccination site is still red), VACCINATION SITE SWELLING (vaccination site puffy), MYALGIA (Body ache) and CHILLS (chills). The patient was treated with PARACETAMOL (TYLENOL) at a dose of 500 milligram. At the time of the report, BURNING SENSATION (burning), PAIN (stinging), VACCINATION SITE BRUISING (red mark like a bruise on the vaccination site), VACCINATION SITE WARMTH (vaccination site warm to the touch), VACCINATION SITE ERYTHEMA (vaccination site is still red), VACCINATION SITE SWELLING (vaccination site puffy), MYALGIA (Body ache), VACCINATION SITE PAIN (pain at vaccination site during the injection), CHILLS (chills) and PYREXIA (fever) had resolved.            No concomitant medications were reported.   This case was linked to MOD-2021-234551 (Patient Link).   Most recent FOLLOW-UP information incorporated above includes: On 19-Jul-2021: Outcome of event updated from unknown to recovered/resolved.
Age: 49.0
Sex: F
Vaccine: COVID19
Symptoms: Vaccination site bruising, Vaccination site erythema, Vaccination site pain, Vaccination site swelling, Vaccination site warmth
Clinical narrative: red mark like a bruise on the vaccination site; vaccination site warm to the touch; vaccination site is still red; vaccination site puffy; Body ache; chills; fever; burning; stinging; pain at vaccination site during the injection; This spontaneous case was reported by a consumer and describes the occurrence of BURNING SENSATION (burning), PAIN (stinging), VACCINATION SITE BRUISING (red mark like a bruise on the vaccination site), VACCINATION SITE WARMTH (vaccination site warm to the touch) and VACCINATION SITE ERYTHEMA (vaccination site is still red) in a 49-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 050C21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.   On 22-Jun-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 22-Jun-2021, the patient experienced BURNING SENSATION (burning), PAIN (stinging), VACCINATION SITE PAIN (pain at vaccination site during the injection) and PYREXIA (fever). On 23-Jun-2021, the patient experienced VACCINATION SITE BRUISING (red mark like a bruise on the vaccination site), VACCINATION SITE WARMTH (vaccination site warm to the touch), VACCINATION SITE ERYTHEMA (vaccination site is still red), VACCINATION SITE SWELLING (vaccination site puffy), MYALGIA (Body ache) and CHILLS (chills). The patient was treated with PARACETAMOL (TYLENOL) at a dose of 500 milligram. At the time of the report, BURNING SENSATION (burning), PAIN (stinging), VACCINATION SITE BRUISING (red mark like a bruise on the vaccination site), VACCINATION SITE WARMTH (vaccination site warm to the touch), VACCINATION SITE ERYTHEMA (vaccination site is still red), VACCINATION SITE SWELLING (vaccination site puffy), MYALGIA (Body ache), VACCINATION SITE PAIN (pain at vaccination site during the injection), CHILLS (chills) and PYREXIA (fever) had resolved.            No concomitant medications were reported.   This case was linked to MOD-2021-234551 (Patient Link).   Most recent FOLLOW-UP information incorporated above includes: On 19-Jul-2021: Outcome of event updated from unknown to recovered/resolved.
Sex: U
Vaccine: COVID19
Symptoms: Arthralgia, Myalgia
Clinical narrative: muscle aches; joint aches; This spontaneous case was reported by a consumer and describes the occurrence of MYALGIA (muscle aches) and ARTHRALGIA (joint aches) 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 MYALGIA (muscle aches) and ARTHRALGIA (joint aches). At the time of the report, MYALGIA (muscle aches) and ARTHRALGIA (joint aches) outcome was unknown.
Sex: F
Vaccine: COVID19
Symptoms: Heavy menstrual bleeding
Clinical narrative: 3 week menstrual cycle; This spontaneous case was reported by a consumer and describes the occurrence of HEAVY MENSTRUAL BLEEDING (3 week menstrual cycle) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.   On an unknown date, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient experienced HEAVY MENSTRUAL BLEEDING (3 week menstrual cycle). At the time of the report, HEAVY MENSTRUAL BLEEDING (3 week menstrual cycle) outcome was unknown.            No concomitant medications was reported. No treatment drug details was reported.
Sex: U
Vaccine: COVID19
Symptoms: Arthralgia, Vaccination site pain
Clinical narrative: pain from shot site; shoulder pain; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE PAIN (pain from shot site) and ARTHRALGIA (shoulder 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 first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced VACCINATION SITE PAIN (pain from shot site) and ARTHRALGIA (shoulder pain). At the time of the report, VACCINATION SITE PAIN (pain from shot site) and ARTHRALGIA (shoulder pain) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No concomitant medications reported by investigator No treatment medications provided by the reporter.
Sex: U
Vaccine: COVID19
Symptoms: Eye pruritus, Eye swelling
Clinical narrative: This spontaneous case reported by a consumer, describes the occurrence of eye pruritus (itchy eyes) and eye swelling (swollen eyes) 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 eye pruritus (itchy eyes) and eye swelling (swollen eyes). At the time of the report, eye pruritus (itchy eyes) and eye swelling (swollen eyes) outcome: unknown. The action taken with mRNA-1273 (Moderna COVID-19 vaccine): unknown.
Age: 44.0
Sex: F
Vaccine: COVID19
Symptoms: Chills, Ear swelling, Illness, Insomnia, Myalgia
Clinical narrative: difficulty sleeping (due to the itching and rash); hives, and it's all over her body including between her fingers; left arm rash/ rash continued all over her body (including ears, neck, chest, back, and legs)/ rash ongoing; left arm itching/ severe itching ongoing; "got sick"; fever; chills; body aches; swelling of face; swelling of ears; This spontaneous case was reported by a consumer and describes the occurrence of PRURITUS (left arm itching/ severe itching ongoing), ILLNESS ("got sick"), PYREXIA (fever), CHILLS (chills) and MYALGIA (body aches) in a 44-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No medical history was provided by the reporter.  The patient's past medical history included No adverse reaction. Concurrent medical conditions included Drug allergy (doxycyclline).   On 29-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 02-Jun-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 02-Jun-2021, the patient experienced PRURITUS (left arm itching/ severe itching ongoing), ILLNESS ("got sick"), PYREXIA (fever), CHILLS (chills), MYALGIA (body aches), SWELLING FACE (swelling of face) and EAR SWELLING (swelling of ears). On 05-Jun-2021, the patient experienced RASH (left arm rash/ rash continued all over her body (including ears, neck, chest, back, and legs)/ rash ongoing). On an unknown date, the patient experienced INSOMNIA (difficulty sleeping (due to the itching and rash)) and URTICARIA (hives, and it's all over her body including between her fingers). The patient was treated with PREDNISONE at an unspecified dose and frequency. At the time of the report, PRURITUS (left arm itching/ severe itching ongoing), ILLNESS ("got sick"), PYREXIA (fever), CHILLS (chills), MYALGIA (body aches), SWELLING FACE (swelling of face), EAR SWELLING (swelling of ears), RASH (left arm rash/ rash continued all over her body (including ears, neck, chest, back, and legs)/ rash ongoing), INSOMNIA (difficulty sleeping (due to the itching and rash)) and URTICARIA (hives, and it's all over her body including between her fingers) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.    no concomitant medications reported. treatment medications included steroids injections.
Age: 44.0
Sex: F
Vaccine: COVID19
Symptoms: Pruritus, Pyrexia, Rash, Swelling face, Urticaria
Clinical narrative: difficulty sleeping (due to the itching and rash); hives, and it's all over her body including between her fingers; left arm rash/ rash continued all over her body (including ears, neck, chest, back, and legs)/ rash ongoing; left arm itching/ severe itching ongoing; "got sick"; fever; chills; body aches; swelling of face; swelling of ears; This spontaneous case was reported by a consumer and describes the occurrence of PRURITUS (left arm itching/ severe itching ongoing), ILLNESS ("got sick"), PYREXIA (fever), CHILLS (chills) and MYALGIA (body aches) in a 44-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No medical history was provided by the reporter.  The patient's past medical history included No adverse reaction. Concurrent medical conditions included Drug allergy (doxycyclline).   On 29-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 02-Jun-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 02-Jun-2021, the patient experienced PRURITUS (left arm itching/ severe itching ongoing), ILLNESS ("got sick"), PYREXIA (fever), CHILLS (chills), MYALGIA (body aches), SWELLING FACE (swelling of face) and EAR SWELLING (swelling of ears). On 05-Jun-2021, the patient experienced RASH (left arm rash/ rash continued all over her body (including ears, neck, chest, back, and legs)/ rash ongoing). On an unknown date, the patient experienced INSOMNIA (difficulty sleeping (due to the itching and rash)) and URTICARIA (hives, and it's all over her body including between her fingers). The patient was treated with PREDNISONE at an unspecified dose and frequency. At the time of the report, PRURITUS (left arm itching/ severe itching ongoing), ILLNESS ("got sick"), PYREXIA (fever), CHILLS (chills), MYALGIA (body aches), SWELLING FACE (swelling of face), EAR SWELLING (swelling of ears), RASH (left arm rash/ rash continued all over her body (including ears, neck, chest, back, and legs)/ rash ongoing), INSOMNIA (difficulty sleeping (due to the itching and rash)) and URTICARIA (hives, and it's all over her body including between her fingers) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.    no concomitant medications reported. treatment medications included steroids injections.
Sex: U
Vaccine: COVID19
Symptoms: Lymph node pain, Lymphadenopathy
Clinical narrative: swollen and sore lymph nodes; swollen and sore lymph nodes; 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 LYMPH NODE PAIN (swollen and sore lymph nodes) and LYMPHADENOPATHY (swollen and sore lymph nodes) 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 LYMPH NODE PAIN (swollen and sore lymph nodes) and LYMPHADENOPATHY (swollen and sore lymph nodes). At the time of the report, LYMPH NODE PAIN (swollen and sore lymph nodes) and LYMPHADENOPATHY (swollen and sore lymph nodes) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No Relevant concomitant medications was reported.  Treatment information was not provided
Age: 77.0
Sex: F
Vaccine: COVID19
Symptoms: Expired product administered
Clinical narrative: patient received a vaccine which was wrong storage and handling; This spontaneous case was reported by a nurse and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (patient received a vaccine which was wrong storage and handling) in a 77-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 017C21A) for COVID-19 vaccination.     No Medical History information was reported.   On 17-Jun-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 17-Jun-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (patient received a vaccine which was wrong storage and handling). At the time of the report, EXPIRED PRODUCT ADMINISTERED (patient received a vaccine which was wrong storage and handling) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   the patient received remdesivir in November .  Action taken with mRNA-1273 in response to the event was not applicable.  Treatment information was not provided. Concomitant product use was not provided.   Most recent FOLLOW-UP information incorporated above includes: On 30-Jun-2021: Non-significant follow-up
Sex: U
Vaccine: COVID19
Symptoms: Rash, Scratch
Clinical narrative: little on my back then scratch marks; little rash on lower back; This spontaneous case was reported by a consumer and describes the occurrence of SCRATCH (little on my back then scratch marks) and RASH (little rash on lower back) 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 SCRATCH (little on my back then scratch marks) and RASH (little rash on lower back). At the time of the report, SCRATCH (little on my back then scratch marks) and RASH (little rash on lower back) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       Concomitant Medications were not provided by the reporter. Treatment Information was not provided by the reporter.
Sex: U
Vaccine: COVID19
Symptoms: Migraine
Clinical narrative: severe headache or migraine; This spontaneous case was reported by a consumer and describes the occurrence of MIGRAINE (severe headache or migraine) 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 MIGRAINE (severe headache or migraine). At the time of the report, MIGRAINE (severe headache or migraine) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No concomitant medications were reported by the reporter. No treatment medications were provided by the reporter.    Reporter did not allow further contact
Age: 82.0
Sex: M
Vaccine: COVID19
Symptoms: Erythema, Rash macular
Clinical narrative: About a month after receiving 2nd dose(in April), he started noticing red marks (burst blood vessels) on both forearms; On his right arm, he has red marks (purple blotchy) about 0.5 inches big/He thought that these blotches may be coming from vaccine/He never had anything like this in the past.; This spontaneous case was reported by a consumer and describes the occurrence of ERYTHEMA (About a month after receiving 2nd dose(in April), he started noticing red marks (burst blood vessels) on both forearms) and RASH MACULAR (On his right arm, he has red marks (purple blotchy) about 0.5 inches big/He thought that these blotches may be coming from vaccine/He never had anything like this in the past.) in an 82-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 047A21A and 031M20A) for COVID-19 vaccination.     No medical history was reported.  Concomitant products included ACETYLSALICYLIC ACID (ASPIRINE), IRBESARTAN (AVAPRO), CARVEDILOL, ATORVASTATIN and COLECALCIFEROL (VITAMIN D [COLECALCIFEROL]) for an unknown indication.   On 24-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 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 an unknown date, the patient experienced ERYTHEMA (About a month after receiving 2nd dose(in April), he started noticing red marks (burst blood vessels) on both forearms) and RASH MACULAR (On his right arm, he has red marks (purple blotchy) about 0.5 inches big/He thought that these blotches may be coming from vaccine/He never had anything like this in the past.). At the time of the report, ERYTHEMA (About a month after receiving 2nd dose(in April), he started noticing red marks (burst blood vessels) on both forearms) and RASH MACULAR (On his right arm, he has red marks (purple blotchy) about 0.5 inches big/He thought that these blotches may be coming from vaccine/He never had anything like this in the past.) outcome was unknown.            For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.  No treatment medications were provided.   Most recent FOLLOW-UP information incorporated above includes: On 21-Jul-2021: Follow-up received and patient demographics updated.
Age: 61.0
Sex: M
Vaccine: COVID19
Symptoms: Product dose omission issue
Clinical narrative: did not receive the second dose as scheduled; This spontaneous case was reported by a consumer and describes the occurrence of PRODUCT DOSE OMISSION ISSUE (did not receive the second dose as scheduled) in a 61-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 014M22A) for COVID-19 vaccination.     The patient's past medical history included Dialysis (3 times a week) since an unknown date.    On 16-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 16-Mar-2021, the patient experienced PRODUCT DOSE OMISSION ISSUE (did not receive the second dose as scheduled). On 16-Mar-2021, PRODUCT DOSE OMISSION ISSUE (did not receive the second dose as scheduled) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   Concomitant medications were not reported.
Sex: U
Vaccine: COVID19
Symptoms: Feeling abnormal, Headache, Myalgia, Pyrexia
Clinical narrative: Fuzzy head; fever; Myalgia; headache; This spontaneous case was reported by a consumer and describes the occurrence of FEELING ABNORMAL (Fuzzy head), PYREXIA (fever), MYALGIA (Myalgia ) and HEADACHE (headache) 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) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced FEELING ABNORMAL (Fuzzy head), PYREXIA (fever), MYALGIA (Myalgia ) and HEADACHE (headache). At the time of the report, FEELING ABNORMAL (Fuzzy head), PYREXIA (fever), MYALGIA (Myalgia ) and HEADACHE (headache) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No concomitant medications reported. No treatment information was provided.
Age: 57.0
Sex: M
Vaccine: COVID19
Symptoms: Malaise
Clinical narrative: not been feeling well; This spontaneous case was reported by a consumer and describes the occurrence of MALAISE (not been feeling well) in a 57-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    In January 2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced MALAISE (not been feeling well). At the time of the report, MALAISE (not been feeling well) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No concomitant medications reported by investigator No treatment medications provided by the reporter.
Sex: U
Vaccine: COVID19
Symptoms: Dizziness
Clinical narrative: This spontaneous case reported by a consumer, describes the occurrence of extreme dizziness 7 days after vaccine 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 Jun 17, 2021, patient received the first dose of mRNA-1273 (Moderna COVID-19 vaccine), unknown route; 1 dosage form. On an unknown date, patient experienced extreme dizziness 7 days after vaccine. At the time of the report, extreme dizziness 7 days after vaccine outcome: unknown. The action taken with mRNA-1273 (Moderna COVID-19 vaccine): unknown. No concomitant medication or treatment information provided.
Sex: M
Vaccine: COVID19
Symptoms: Incorrect route of product administration
Clinical narrative: shot given in shoulder bone; This spontaneous case was reported by an other health care professional and describes the occurrence of INCORRECT ROUTE OF PRODUCT ADMINISTRATION (shot given in shoulder bone) 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 INCORRECT ROUTE OF PRODUCT ADMINISTRATION (shot given in shoulder bone). At the time of the report, INCORRECT ROUTE OF PRODUCT ADMINISTRATION (shot given in shoulder bone) 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.   Concomitant medication was not provided.  Treatment information was not provided.
Age: 17.0
Sex: U
Vaccine: COVID19
Symptoms: Product administered to patient of inappropriate age
Clinical narrative: vaccine given to 17 year old; This spontaneous case was reported by a pharmacist and describes the occurrence of PRODUCT ADMINISTERED TO PATIENT OF INAPPROPRIATE AGE (vaccine given to 17 year old) in a 17-year-old patient of an unknown gender who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 038C21A) for COVID-19 vaccination.     No Medical History information was reported.    On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced PRODUCT ADMINISTERED TO PATIENT OF INAPPROPRIATE AGE (vaccine given to 17 year old). At the time of the report, PRODUCT ADMINISTERED TO PATIENT OF INAPPROPRIATE AGE (vaccine given to 17 year old) 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 treatment medications reported.
Age: 43.0
Sex: U
Vaccine: COVID19
Symptoms: Expired product administered
Clinical narrative: vaccines from vials that had been thawed more than 30 days ago were administered; This spontaneous case was reported by an other health care professional and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (vaccines from vials that had been thawed more than 30 days ago were administered) in a 43-year-old patient of an unknown gender who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 036C21A) for COVID-19 vaccination.     No Medical History information was reported.    On 17-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 EXPIRED PRODUCT ADMINISTERED (vaccines from vials that had been thawed more than 30 days ago were administered). At the time of the report, EXPIRED PRODUCT ADMINISTERED (vaccines from vials that had been thawed more than 30 days ago were administered) 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 medication  was reported. No treatment information was provided by the reporter.
Age: 22.0
Sex: M
Vaccine: COVID19
Symptoms: Chills, Pyrexia
Clinical narrative: low grade fever; chills; This spontaneous case was reported by a consumer and describes the occurrence of PYREXIA (low grade fever) and CHILLS (chills) in a 22-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.   On an unknown date, the patient received 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 PYREXIA (low grade fever) and CHILLS (chills). At the time of the report, PYREXIA (low grade fever) and CHILLS (chills) outcome was unknown.            No relevant concomitant medication was reported.  No treatment medication was reported.    Reporter did not allow further contact
Age: 40.0
Sex: U
Vaccine: COVID19
Symptoms: Expired product administered
Clinical narrative: vaccines from vials that had been thawed more than 30 days ago were administered; This case was received via an unknown source (no reference has been entered for a health authority or license partner) on 24-Jun-2021 and was forwarded to Moderna on 24-Jun-2021.    This spontaneous case was reported by a health care professional and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (vaccines from vials that had been thawed more than 30 days ago were administered) in a 40-year-old patient of an unknown gender who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 3002920) for COVID-19 vaccination.     No Medical History information was reported.    On 17-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 EXPIRED PRODUCT ADMINISTERED (vaccines from vials that had been thawed more than 30 days ago were administered). At the time of the report, EXPIRED PRODUCT ADMINISTERED (vaccines from vials that had been thawed more than 30 days ago were administered) had not 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 medication was provided. No treatment information was provided by the reporter.
Sex: U
Vaccine: COVID19
Symptoms: Rash
Clinical narrative: My arm has a big rash; This spontaneous case was reported by a consumer and describes the occurrence of RASH (My arm has a big rash) 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) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced RASH (My arm has a big rash). At the time of the report, RASH (My arm has a big rash) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No concomitant medications information were reported.  Treatment information was not reported..
Sex: U
Vaccine: COVID19
Symptoms: Vaccination complication
Clinical narrative: Report side effect; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION COMPLICATION (Report side effect) 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 VACCINATION COMPLICATION (Report side effect). At the time of the report, VACCINATION COMPLICATION (Report side effect) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       The patient called because after receiving the first vaccine side effects, that where not mentioned as normal when giving the vaccine, were developed. Wanted to know if there was any chance of receiving only one dose instead of two doses.  no concomitant medications are provided.
Age: 17.0
Sex: U
Vaccine: COVID19
Symptoms: Product administered to patient of inappropriate age
Clinical narrative: Vaccine given to 17 year old; This spontaneous case was reported by a pharmacist and describes the occurrence of PRODUCT ADMINISTERED TO PATIENT OF INAPPROPRIATE AGE (Vaccine given to 17 year old) in a 17-year-old patient of an unknown gender who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 024C21A and 038C21A) 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 PRODUCT ADMINISTERED TO PATIENT OF INAPPROPRIATE AGE (Vaccine given to 17 year old). At the time of the report, PRODUCT ADMINISTERED TO PATIENT OF INAPPROPRIATE AGE (Vaccine given to 17 year old) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   Concomitant product use was not provided by the reporter.  Treatment information was not provided by the reporter.
Age: 65.0
Sex: U
Vaccine: COVID19
Symptoms: Expired product administered
Clinical narrative: vaccines from vials that had been thawed more than 30 days ago were administered; This spontaneous case was reported by an other health care professional and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (vaccines from vials that had been thawed more than 30 days ago were administered) in a 65-year-old patient of an unknown gender who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 036C21A) for COVID-19 vaccination.     No Medical History information was reported.    On 17-Jun-2021, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 17-Jun-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (vaccines from vials that had been thawed more than 30 days ago were administered). On 17-Jun-2021, EXPIRED PRODUCT ADMINISTERED (vaccines from vials that had been thawed more than 30 days ago were administered) 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 medication was provided by the reporter. No treatment information were provided by the reporter.       Most recent FOLLOW-UP information incorporated above includes: On 03-Aug-2021: Follow up received included no new significant information. Awaiting translation.
Age: 49.0
Sex: F
Vaccine: COVID19
Symptoms: Chromaturia, Dysuria, Pollakiuria
Clinical narrative: Little cramping and uncomfortable feeling only when urinating and felt burning at the end of the urination; Little tiny light pink in urine/After 30 minutes when urinate again it has little red; Pee more than the usual and this was just after the vaccine; This spontaneous case was reported by a consumer and describes the occurrence of DYSURIA (Little cramping and uncomfortable feeling only when urinating and felt burning at the end of the urination), CHROMATURIA (Little tiny light pink in urine/After 30 minutes when urinate again it has little red) and POLLAKIURIA (Pee more than the usual and this was just after the vaccine) in a 49-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 051c21a) for COVID-19 vaccination.     No medical history was provided by the reporter.  Concomitant products included AMLODIPINE for an unknown indication.    On 23-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 DYSURIA (Little cramping and uncomfortable feeling only when urinating and felt burning at the end of the urination), CHROMATURIA (Little tiny light pink in urine/After 30 minutes when urinate again it has little red) and POLLAKIURIA (Pee more than the usual and this was just after the vaccine). At the time of the report, DYSURIA (Little cramping and uncomfortable feeling only when urinating and felt burning at the end of the urination), CHROMATURIA (Little tiny light pink in urine/After 30 minutes when urinate again it has little red) and POLLAKIURIA (Pee more than the usual and this was just after the vaccine) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       The patient took Tylenol right after the vaacination, for unknown indication.
Sex: U
Vaccine: COVID19
Symptoms: Exposure during pregnancy
Clinical narrative: Does this vaccine affect anyone from having a pregnancy or from becoming a parent; This spontaneous case was reported by a consumer and describes the occurrence of EXPOSURE DURING PREGNANCY (Does this vaccine affect anyone from having a pregnancy or from becoming a parent) 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 EXPOSURE DURING PREGNANCY (Does this vaccine affect anyone from having a pregnancy or from becoming a parent). At the time of the report, EXPOSURE DURING PREGNANCY (Does this vaccine affect anyone from having a pregnancy or from becoming a parent) had resolved.            Concomitant medications were not reported. No treatment medication details was reported.
Sex: F
Vaccine: COVID19
Symptoms: Inappropriate schedule of product administration
Clinical narrative: received the first dose of the Moderna vaccine on 02Apr2021 and has not received the second dose yet; This spontaneous case was reported by a pharmacist and describes the occurrence of INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (received the first dose of the Moderna vaccine on 02Apr2021 and has not received the second dose yet) 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 02-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (received the first dose of the Moderna vaccine on 02Apr2021 and has not received the second dose yet). At the time of the report, INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (received the first dose of the Moderna vaccine on 02Apr2021 and has not received the second dose yet) 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 medication was mentioned. No treatment medication was mentioned.