chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 62.0
Sex: M
Vaccine: COVID19
Symptoms: Hypoaesthesia oral, Lip swelling, Memory impairment, Pain assessment, Vaccination site pain
Clinical narrative: left side of his lower lip inflated, Lip was big - triple the size; Lip was numb; "sometimes he forgets where he put his keys, but this will keep happening"; gets woken up by pain where the injection was made - in that circle,It "bothers the hell out of him",Pain at a 4/10,; This spontaneous case was reported by an other health care professional and describes the occurrence of LIP SWELLING (left side of his lower lip inflated, Lip was big - triple the size), HYPOAESTHESIA ORAL (Lip was numb), MEMORY IMPAIRMENT ("sometimes he forgets where he put his keys, but this will keep happening") and VACCINATION SITE PAIN (gets woken up by pain where the injection was made - in that circle,It "bothers the hell out of him",Pain at a 4/10,) in a 62-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 032B21A and 028A21A) for COVID-19 vaccination.     The patient's past medical history included Hepatitis C (Hepatitis C from the 80s until 2015 - never had any symptoms.). Concomitant products included TRAZODONE, ACETYLSALICYLIC ACID, DIPHENHYDRAMINE CITRATE (ALKA-SELTZER PM) and IBUPROFEN (MOTRIN [IBUPROFEN]) for an unknown indication.   On 01-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 29-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 30-Apr-2021, the patient experienced LIP SWELLING (left side of his lower lip inflated, Lip was big - triple the size), HYPOAESTHESIA ORAL (Lip was numb), MEMORY IMPAIRMENT ("sometimes he forgets where he put his keys, but this will keep happening") and VACCINATION SITE PAIN (gets woken up by pain where the injection was made - in that circle,It "bothers the hell out of him",Pain at a 4/10,). The patient was treated with DIPHENHYDRAMINE HYDROCHLORIDE (BENADRYL [DIPHENHYDRAMINE HYDROCHLORIDE]) for Lip swelling, at a dose of 1 dosage form. On 02-May-2021, LIP SWELLING (left side of his lower lip inflated, Lip was big - triple the size) and HYPOAESTHESIA ORAL (Lip was numb) had resolved. At the time of the report, MEMORY IMPAIRMENT ("sometimes he forgets where he put his keys, but this will keep happening") and VACCINATION SITE PAIN (gets woken up by pain where the injection was made - in that circle,It "bothers the hell out of him",Pain at a 4/10,) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, Pain assessment: 4/10 (High) Pain at a 4/10.     For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   Now, the patient is concerned because of the booster - his workplace is requesting for everyone to get vaccinated, but he doesn't know if he will get it.
Age: 31.0
Sex: F
Vaccine: COVID19
Symptoms: Anxiety, Feeling hot, Feeling of despair, Nervousness
Clinical narrative: Nervous; Warmness inside her body; Desperation; Anxiety attack/feelings of anxiety; This spontaneous case was reported by a consumer and describes the occurrence of ANXIETY (Anxiety attack/feelings of anxiety), NERVOUSNESS (Nervous), FEELING HOT (Warmness inside her body) and FEELING OF DESPAIR (Desperation) in a 31-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 047b21a) for COVID-19 vaccination.     No Medical History information was reported.    On 13-Jul-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 17-Jul-2021, the patient experienced ANXIETY (Anxiety attack/feelings of anxiety). On an unknown date, the patient experienced NERVOUSNESS (Nervous), FEELING HOT (Warmness inside her body) and FEELING OF DESPAIR (Desperation). At the time of the report, ANXIETY (Anxiety attack/feelings of anxiety), NERVOUSNESS (Nervous), FEELING HOT (Warmness inside her body) and FEELING OF DESPAIR (Desperation) had not resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Treatment information was not provided. Concomitant medication includes anxiety pills.   The patient went to ER and she had  a fear before vaccination.
Sex: U
Vaccine: COVID19
Symptoms: Nausea
Clinical narrative: Be nauseated for up to 8 to 10 days after the 1st round of the vaccine; This spontaneous case was reported by a consumer and describes the occurrence of NAUSEA (Be nauseated for up to 8 to 10 days after the 1st round of the 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 first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced NAUSEA (Be nauseated for up to 8 to 10 days after the 1st round of the vaccine). At the time of the report, NAUSEA (Be nauseated for up to 8 to 10 days after the 1st round of the vaccine) had resolved.     The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No concomitant medications were provided by reporter. No treatment details were provided by reporter.
Age: 32.0
Sex: F
Vaccine: COVID19
Symptoms: Angioedema, Autoimmune disorder, Eye swelling, Lip swelling, Urticaria
Clinical narrative: angioedema; autoimmune disease; chronic hives that cover the legs\arms; swelling of the lips; swelling of the eyes; This spontaneous case was reported by a consumer (subsequently medically confirmed) and describes the occurrence of ANGIOEDEMA (angioedema) and AUTOIMMUNE DISORDER (autoimmune disease) in a 32-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 017C21A and 037A21B) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     Concurrent medical conditions included Shellfish allergy (Shellfish allergy).   On 14-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 12-May-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 ANGIOEDEMA (angioedema) (seriousness criterion medically significant), AUTOIMMUNE DISORDER (autoimmune disease) (seriousness criterion medically significant), URTICARIA (chronic hives that cover the legs\arms), LIP SWELLING (swelling of the lips) and EYE SWELLING (swelling of the eyes). At the time of the report, ANGIOEDEMA (angioedema), AUTOIMMUNE DISORDER (autoimmune disease), URTICARIA (chronic hives that cover the legs\arms), LIP SWELLING (swelling of the lips) and EYE SWELLING (swelling of the eyes) outcome was unknown.            The patient two and a half weeks after getting the second dose started having chronic hives that cover the legs and arms, it happened during night when she was sleeping and during the day it gets better with the treatment. She had seen several doctors for infectious diseases, immunologist, rheumatologist, dermatologist, which had been tested for autoimmune diseases, blood cancer, parasites, for every allergy and sensitivities (food, medicines, latex). The doctors think that it's like the vaccine triggered some kind of autoimmune disease and the body was trying to fight the vaccine. She had no allergies, only shellfish allergy, the only one she had tested positive for. The patient had been on several medicines since it was started but the symptoms persist.  Company Comment: Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded.; Sender's Comments: Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded.
Sex: U
Vaccine: COVID19
Symptoms: Thrombosis
Clinical narrative: blood clots; 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 THROMBOSIS (blood clots) 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 THROMBOSIS (blood clots) (seriousness criterion medically significant). At the time of the report, THROMBOSIS (blood clots) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Patient learned about possible heart inflammation.  No concomitant medications were provided by the reporter.  No treatment information was provided by the reporter.  Very limited information regarding this event/s has been provided at this time. No further information is expected.   Reporter did not allow further contact; Sender's Comments: Very limited information regarding this event/s has been provided at this time. No further information is expected.
Sex: U
Vaccine: COVID19
Symptoms: Abdominal discomfort, Abdominal pain, Haematochezia
Clinical narrative: Bleeding when passing bowels; Worst belly ache; Gut is the problem area; 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 HAEMATOCHEZIA (Bleeding when passing bowels) in a  patient of an unknown age and gender 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 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 HAEMATOCHEZIA (Bleeding when passing bowels) (seriousness criterion medically significant), ABDOMINAL PAIN (Worst belly ache) and ABDOMINAL DISCOMFORT (Gut is the problem area). At the time of the report, HAEMATOCHEZIA (Bleeding when passing bowels), ABDOMINAL PAIN (Worst belly ache) and ABDOMINAL DISCOMFORT (Gut is the problem area) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No relevant concomitant medication information provided. No relevant treatment medication information provided.  As per report due to this event patient could not take certain vitamins.  Very limited information regarding these events has been provided at this time.; Sender's Comments: Very limited information regarding these events has been provided at this time.
Age: 53.0
Sex: F
Vaccine: COVID19
Symptoms: Anaphylactic reaction, Feeling abnormal, Peripheral swelling, Vaccination site reaction
Clinical narrative: vaccination site had a rebound reaction/the site she said she looked like a lobster; anaphylaxis; arm got swollen; feeling like crap; This spontaneous case was reported by a consumer and describes the occurrence of ANAPHYLACTIC REACTION (anaphylaxis) in a 53-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 048A21A and 028620A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     The patient's past medical history included Lung operation NOS (she was holding her right side since she could not inflate right lung due to surgery.). Concurrent medical conditions included Hernia. Concomitant products included PREDNISONE and FAMOTIDINE (PEPCID [FAMOTIDINE]) for Hernia NOS.   On 12-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 13-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 13-Mar-2021, the patient experienced ANAPHYLACTIC REACTION (anaphylaxis) (seriousness criterion medically significant), PERIPHERAL SWELLING (arm got swollen) and FEELING ABNORMAL (feeling like crap). On an unknown date, the patient experienced VACCINATION SITE REACTION (vaccination site had a rebound reaction/the site she said she looked like a lobster). The patient was treated with EPINEPHRINE (EPIPEN) at an unspecified dose and frequency and DIPHENHYDRAMINE HYDROCHLORIDE (BENADRYL [DIPHENHYDRAMINE HYDROCHLORIDE]) at a dose of 50 mg every six hours. At the time of the report, ANAPHYLACTIC REACTION (anaphylaxis), PERIPHERAL SWELLING (arm got swollen), FEELING ABNORMAL (feeling like crap) and VACCINATION SITE REACTION (vaccination site had a rebound reaction/the site she said she looked like a lobster) had not resolved.            Event includes:while at the site she said she looked like a lobster  Based on the current available information and temporal association between the use of the product, and the start date of the events, a causal relationship cannot be excluded.   This case was linked to MOD-2021-291221 (Patient Link).; Sender's Comments: Based on the current available information and temporal association between the use of the product, and the start date of the events, a causal relationship cannot be excluded.
Sex: U
Vaccine: COVID19
Symptoms: Dyspnoea
Clinical narrative: trouble breathing; This spontaneous case was reported by a consumer and describes the occurrence of DYSPNOEA (trouble breathing) 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 DYSPNOEA (trouble breathing). At the time of the report, DYSPNOEA (trouble breathing) 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.  Company Comment: Very limited information regarding this event has been provided at this time. Further information has been requested.; Sender's Comments: Very limited information regarding this event has been provided at this time. Further information has been requested.
Sex: U
Vaccine: COVID19
Symptoms: Thrombosis
Clinical narrative: There was 1 doctor that got blood clot after receiving moderna vaccine; 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 THROMBOSIS (There was 1 doctor that got blood clot after receiving moderna vaccine) in a patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. Unknown) for COVID-19 vaccination.     No Medical History information was reported.    On an unknown date, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage form. On an unknown date, the patient experienced THROMBOSIS (There was 1 doctor that got blood clot after receiving moderna vaccine) (seriousness criterion medically significant). At the time of the report, THROMBOSIS (There was 1 doctor that got blood clot after receiving moderna vaccine) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No concomitant medications were provided. Treatment medications was not provided.  Agent crosslinked this case to MOD21-132671.  Very limited information regarding this event has been provided at this time. Further information regarding temporal association is necessary. Further information has been requested.   Reporter did not allow further contact; Sender's Comments: Very limited information regarding this event has been provided at this time. Further information regarding temporal association is necessary. Further information has been requested.
Sex: U
Vaccine: COVID19
Symptoms: Drug reaction with eosinophilia and systemic symptoms
Clinical narrative: Causing DRESS syndrome; 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 DRUG REACTION WITH EOSINOPHILIA AND SYSTEMIC SYMPTOMS (Causing DRESS syndrome) 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 DRUG REACTION WITH EOSINOPHILIA AND SYSTEMIC SYMPTOMS (Causing DRESS syndrome) (seriousness criterion medically significant). At the time of the report, DRUG REACTION WITH EOSINOPHILIA AND SYSTEMIC SYMPTOMS (Causing DRESS syndrome) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       The concomitant medications were not reported. The treatment information was not provided.  Company Comment: Based on the current available information and no temporal association between the use of the product and the start date of the event, a causal relationship cannot be excluded.  More information has been requested.; Sender's Comments: Based on the current available information and no temporal association between the use of the product and the start date of the event, a causal relationship cannot be excluded.  More information has been requested.
Sex: M
Vaccine: COVID19
Symptoms: Vaccine breakthrough infection
Clinical narrative: breakthrough case; This spontaneous case was reported by a consumer and describes the occurrence of VACCINE BREAKTHROUGH INFECTION (breakthrough case) 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 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 VACCINE BREAKTHROUGH INFECTION (breakthrough case) (seriousness criterion medically significant). At the time of the report, VACCINE BREAKTHROUGH INFECTION (breakthrough case) outcome was unknown.            The concomitant history was not reported. The treatment history was not provided. Patient had taken a booster shot.  Company Comment: Very limited information regarding these events has been provided at this time. Further information is not to be expected.   Reporter did not allow further contact; Sender's Comments: Very limited information regarding these events has been provided at this time.  Further information is not to be expected.
Sex: U
Vaccine: COVID19
Symptoms: Neoplasm malignant
Clinical narrative: After the first vaccine the patient was diagnosed with cancer; Based on the current case data, this case has been classified as invalid. This spontaneous case was reported by a pharmacist and describes the occurrence of NEOPLASM MALIGNANT (After the first vaccine the patient was diagnosed with cancer) 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 28-Jul-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 NEOPLASM MALIGNANT (After the first vaccine the patient was diagnosed with cancer) (seriousness criterion medically significant). At the time of the report, NEOPLASM MALIGNANT (After the first vaccine the patient was diagnosed with cancer) 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.   Concomitant products were not provided.  On 27-Aug-2021, the patient would get first chemo treatment. The patient's oncologist wants the patient to get the second shot asap before their chemo therapy.  Company comment: Very limited information regarding this event has been provided at this time.  However, considering the pathophysiology of a malignant neoplasm, it's unlikely the reported event is related to Moderna Vaccine. Further information has been requested.; Sender's Comments: Very limited information regarding this event has been provided at this time.  However, considering the pathophysiology of a malignant neoplasm, it's unlikely the reported event is related to Moderna Vaccine. Further information has been requested.
Age: 59.0
Sex: F
Vaccine: COVID19
Symptoms: Contusion, Fall, Multiple sclerosis
Clinical narrative: She further stated that "it was like the vaccine just kicked up (her) MS and took her legs from under her" positive; Fell and hit her head and hit her back; Face was bruised all on the side and she "was all messed up"; This spontaneous case was reported by a consumer and describes the occurrence of MULTIPLE SCLEROSIS (She further stated that "it was like the vaccine just kicked up (her) MS and took her legs from under her" positive) in a 60-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     Concurrent medical conditions included Type 1 diabetes mellitus and Multiple sclerosis (primary progressive multiple sclerosis). Concomitant products included OCRELIZUMAB (OCREVUS) for an unknown indication.   In February 2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. In March 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 MULTIPLE SCLEROSIS (She further stated that "it was like the vaccine just kicked up (her) MS and took her legs from under her" positive) (seriousness criterion medically significant), FALL (Fell and hit her head and hit her back) and CONTUSION (Face was bruised all on the side and she "was all messed up"). At the time of the report, MULTIPLE SCLEROSIS (She further stated that "it was like the vaccine just kicked up (her) MS and took her legs from under her" positive), FALL (Fell and hit her head and hit her back) and CONTUSION (Face was bruised all on the side and she "was all messed up") outcome was unknown.            No treatment details reported.  Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded.   This case was linked to MOD-2021-291888 (Patient Link).; Sender's Comments: Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded.
Age: 67.0
Sex: F
Vaccine: COVID19
Symptoms: Blood pressure systolic, Dizziness, Dysphagia, Flushing, Heart rate
Clinical narrative: 1st dose 07Jan2021; no 2nd dose; flushing; light headed; difficulty swallowing her saliva; This spontaneous case was reported by a physician (subsequently medically confirmed) and describes the occurrence of FLUSHING (flushing), DIZZINESS (light headed) and DYSPHAGIA (difficulty swallowing her saliva) in a 67-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 011L20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.    On 07-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) .5 milliliter. On 07-Jan-2021, the patient experienced FLUSHING (flushing) (seriousness criterion medically significant), DIZZINESS (light headed) (seriousness criterion medically significant) and DYSPHAGIA (difficulty swallowing her saliva) (seriousness criterion medically significant). On an unknown date, the patient experienced PRODUCT DOSE OMISSION ISSUE (1st dose 07Jan2021; no 2nd dose). The patient was treated with DIPHENHYDRAMINE HYDROCHLORIDE (BENADRYL [DIPHENHYDRAMINE HYDROCHLORIDE]) at a dose of 1 dosage form and OXYGEN on 07-Jan-2021 at a dose of 1 dosage form. On 07-Jan-2021, FLUSHING (flushing), DIZZINESS (light headed) and DYSPHAGIA (difficulty swallowing her saliva) had resolved. At the time of the report, PRODUCT DOSE OMISSION ISSUE (1st dose 07Jan2021; no 2nd dose) had resolved.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 07-Jan-2021, Blood pressure systolic: 133 to188 (High) from 133 to188. On 07-Jan-2021, Heart rate: 74 to 118 (High) heart rate went up from 74 to 118.     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 information was not provided by reporter.  Patient  was given Benadryl and O2 but the symptoms persisted so patient was taken to the emergency room (ER). At the ER, she was given steroids and O2.  Company Comment : This report refers to a case of Product dose omission issue with associated AEs. Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded.; Sender's Comments: This report refers to a case of Product dose omission issue with associated AEs. Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded.
Age: 67.0
Sex: F
Vaccine: COVID19
Symptoms: Product dose omission issue
Clinical narrative: 1st dose 07Jan2021; no 2nd dose; flushing; light headed; difficulty swallowing her saliva; This spontaneous case was reported by a physician (subsequently medically confirmed) and describes the occurrence of FLUSHING (flushing), DIZZINESS (light headed) and DYSPHAGIA (difficulty swallowing her saliva) in a 67-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 011L20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.    On 07-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) .5 milliliter. On 07-Jan-2021, the patient experienced FLUSHING (flushing) (seriousness criterion medically significant), DIZZINESS (light headed) (seriousness criterion medically significant) and DYSPHAGIA (difficulty swallowing her saliva) (seriousness criterion medically significant). On an unknown date, the patient experienced PRODUCT DOSE OMISSION ISSUE (1st dose 07Jan2021; no 2nd dose). The patient was treated with DIPHENHYDRAMINE HYDROCHLORIDE (BENADRYL [DIPHENHYDRAMINE HYDROCHLORIDE]) at a dose of 1 dosage form and OXYGEN on 07-Jan-2021 at a dose of 1 dosage form. On 07-Jan-2021, FLUSHING (flushing), DIZZINESS (light headed) and DYSPHAGIA (difficulty swallowing her saliva) had resolved. At the time of the report, PRODUCT DOSE OMISSION ISSUE (1st dose 07Jan2021; no 2nd dose) had resolved.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 07-Jan-2021, Blood pressure systolic: 133 to188 (High) from 133 to188. On 07-Jan-2021, Heart rate: 74 to 118 (High) heart rate went up from 74 to 118.     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 information was not provided by reporter.  Patient  was given Benadryl and O2 but the symptoms persisted so patient was taken to the emergency room (ER). At the ER, she was given steroids and O2.  Company Comment : This report refers to a case of Product dose omission issue with associated AEs. Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded.; Sender's Comments: This report refers to a case of Product dose omission issue with associated AEs. Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded.
Age: 63.0
Sex: F
Vaccine: COVID19
Symptoms: Decreased appetite, Dyspepsia, Electrocardiogram, Gastritis, Malaise
Clinical narrative: Went to ER after 2nd dose which "showed possible old heart attack"; for the last 5 -6 weeks she has had bad gastritis; burning in stomach up into throat.; has not been feeling well overall; "can barley eat or drink"; This spontaneous case was reported by a consumer and describes the occurrence of MYOCARDIAL INFARCTION (Went to ER after 2nd dose which "showed possible old heart attack") in a 63-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 038C21A and 005C21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     The patient's past medical history included GERD (used lansoprazole 30mg daily). Concomitant products included HYDROXYZINE EMBONATE (VISTARIL [HYDROXYZINE EMBONATE]), BIOTIN, VITAMIN B12 [VITAMIN B12 NOS], VITAMIN D3, MIRABEGRON (MYRBETRIQ) and BUPROPION HCL for an unknown indication.   On 26-May-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 25-Jun-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 MYOCARDIAL INFARCTION (Went to ER after 2nd dose which "showed possible old heart attack") (seriousness criterion medically significant), GASTRITIS (for the last 5 -6 weeks she has had bad gastritis), DYSPEPSIA (burning in stomach up into throat.), MALAISE (has not been feeling well overall) and DECREASED APPETITE ("can barley eat or drink"). The patient was treated with FAMOTIDINE (FAMOTIDINE ACID REDUCER) for Adverse event, at a dose of 40 milligram. At the time of the report, MYOCARDIAL INFARCTION (Went to ER after 2nd dose which "showed possible old heart attack"), GASTRITIS (for the last 5 -6 weeks she has had bad gastritis), DYSPEPSIA (burning in stomach up into throat.), MALAISE (has not been feeling well overall) and DECREASED APPETITE ("can barley eat or drink") outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, Electrocardiogram: normal (normal) normal.         Patient states she received the 2nd dose on 25Jun2021 and for the last 5 -6 weeks she has had bad gastritis, burning in stomach up into throat. Says she has not been feeling well overall and "can barley eat or drink". Reports she has been to the doctor twice and and has had one ER visit since receiving the second dose and wonders if these symptoms are an adverse reaction. Went to ER after 2nd dose which "showed possible old heart attack" SAE form filled out 19Aug2021  Says doctors asked if she has taken anything or Aleve for pain which she declined.  Company comment- Very limited information regarding these events has been provided at this time.; Sender's Comments: Very limited information regarding these events has been provided at this time.
Age: 63.0
Sex: F
Vaccine: COVID19
Symptoms: Myocardial infarction
Clinical narrative: Went to ER after 2nd dose which "showed possible old heart attack"; for the last 5 -6 weeks she has had bad gastritis; burning in stomach up into throat.; has not been feeling well overall; "can barley eat or drink"; This spontaneous case was reported by a consumer and describes the occurrence of MYOCARDIAL INFARCTION (Went to ER after 2nd dose which "showed possible old heart attack") in a 63-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 038C21A and 005C21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     The patient's past medical history included GERD (used lansoprazole 30mg daily). Concomitant products included HYDROXYZINE EMBONATE (VISTARIL [HYDROXYZINE EMBONATE]), BIOTIN, VITAMIN B12 [VITAMIN B12 NOS], VITAMIN D3, MIRABEGRON (MYRBETRIQ) and BUPROPION HCL for an unknown indication.   On 26-May-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 25-Jun-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 MYOCARDIAL INFARCTION (Went to ER after 2nd dose which "showed possible old heart attack") (seriousness criterion medically significant), GASTRITIS (for the last 5 -6 weeks she has had bad gastritis), DYSPEPSIA (burning in stomach up into throat.), MALAISE (has not been feeling well overall) and DECREASED APPETITE ("can barley eat or drink"). The patient was treated with FAMOTIDINE (FAMOTIDINE ACID REDUCER) for Adverse event, at a dose of 40 milligram. At the time of the report, MYOCARDIAL INFARCTION (Went to ER after 2nd dose which "showed possible old heart attack"), GASTRITIS (for the last 5 -6 weeks she has had bad gastritis), DYSPEPSIA (burning in stomach up into throat.), MALAISE (has not been feeling well overall) and DECREASED APPETITE ("can barley eat or drink") outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, Electrocardiogram: normal (normal) normal.         Patient states she received the 2nd dose on 25Jun2021 and for the last 5 -6 weeks she has had bad gastritis, burning in stomach up into throat. Says she has not been feeling well overall and "can barley eat or drink". Reports she has been to the doctor twice and and has had one ER visit since receiving the second dose and wonders if these symptoms are an adverse reaction. Went to ER after 2nd dose which "showed possible old heart attack" SAE form filled out 19Aug2021  Says doctors asked if she has taken anything or Aleve for pain which she declined.  Company comment- Very limited information regarding these events has been provided at this time.; Sender's Comments: Very limited information regarding these events has been provided at this time.
Sex: F
Vaccine: COVID19
Symptoms: Decreased immune responsiveness
Clinical narrative: Low Immunity; This spontaneous case was reported by a consumer and describes the occurrence of DECREASED IMMUNE RESPONSIVENESS (Low Immunity) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     Concurrent medical conditions included Immunocompromised. Concomitant products included INFLIXIMAB (REMICADE) and MYCOPHENOLATE MOFETIL HYDROCHLORIDE (CELLCEPT [MYCOPHENOLATE MOFETIL HYDROCHLORIDE]) for an unknown indication.    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 DECREASED IMMUNE RESPONSIVENESS (Low Immunity). At the time of the report, DECREASED IMMUNE RESPONSIVENESS (Low Immunity) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.    No Treatment Medications were provided.
Sex: F
Vaccine: COVID19
Symptoms: Blindness, Skin discolouration, Syncope
Clinical narrative: fainted and collapsed; eyes were opened and she went blind in both eyes; turned white, lips turned green; This spontaneous case was reported by a consumer and describes the occurrence of SYNCOPE (fainted and collapsed) and BLINDNESS (eyes were opened and she went blind in both eyes) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     Concurrent medical conditions included Smoker (smokes cigarettes).    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 SYNCOPE (fainted and collapsed) (seriousness criterion medically significant), BLINDNESS (eyes were opened and she went blind in both eyes) (seriousness criterion medically significant) and SKIN DISCOLOURATION (turned white, lips turned green). At the time of the report, SYNCOPE (fainted and collapsed), BLINDNESS (eyes were opened and she went blind in both eyes) and SKIN DISCOLOURATION (turned white, lips turned green) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No treatment information was provided Patient was taking  birth control pills.  Company comment- Very limited information regarding these events has been provided at this time; Sender's Comments: Very limited information regarding these events has been provided at this time
Sex: U
Vaccine: COVID19
Symptoms: Angina pectoris, Carditis
Clinical narrative: heart inflammation; heart pain; This spontaneous case was reported by a consumer and describes the occurrence of CARDITIS (heart inflammation) and ANGINA PECTORIS (heart 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 CARDITIS (heart inflammation) (seriousness criterion medically significant) and ANGINA PECTORIS (heart pain) (seriousness criterion medically significant). At the time of the report, CARDITIS (heart inflammation) and ANGINA PECTORIS (heart pain) outcome was unknown.            No concomitant medication details was provided. No treatment medication details was provided. Company Comment: Vey limited information regarding these events has been provided at this time. Further information has been requested.   This case was linked to MOD-2021-291666 (Patient Link).; Sender's Comments: Vey limited information regarding these events has been provided at this time. Further information has been requested.
Age: 61.0
Sex: M
Vaccine: COVID19
Symptoms: Blindness, Diplopia, Eye disorder, Pain, Photophobia
Clinical narrative: Legally blind in both eyes; In pain; Had double & triple vision; Extreme light sensitivity; Multiple diseases on multiple layers of his eyes; This spontaneous case was reported by a consumer and describes the occurrence of BLINDNESS (Legally blind in both eyes), PAIN (In pain), DIPLOPIA (Had double & triple vision), PHOTOPHOBIA (Extreme light sensitivity) and EYE DISORDER (Multiple diseases on multiple layers of his eyes) in a 61-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 007M20A, 038K20A and 052E21A) for COVID-19 vaccination.     The patient's past medical history included Eye discomfort (Patient has history of eye problems dating back 30years) in 1991, Blepharoconjunctivitis, unspecified and Uveitis. Concurrent medical conditions included Immunocompromised. Concomitant products included PREDNISONE for an unknown indication.   On 27-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 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 16-Aug-2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient experienced BLINDNESS (Legally blind in both eyes) (seriousness criteria hospitalization and medically significant), PAIN (In pain) (seriousness criterion hospitalization), DIPLOPIA (Had double & triple vision) (seriousness criterion hospitalization), PHOTOPHOBIA (Extreme light sensitivity) (seriousness criterion hospitalization) and EYE DISORDER (Multiple diseases on multiple layers of his eyes) (seriousness criterion hospitalization). At the time of the report, BLINDNESS (Legally blind in both eyes), PAIN (In pain), DIPLOPIA (Had double & triple vision), PHOTOPHOBIA (Extreme light sensitivity) and EYE DISORDER (Multiple diseases on multiple layers of his eyes) was resolving.            Patient went to Clinic, Hospital, and a another major eye clinic for treatment after the 2nd shot & they never connected it with the vaccine.  They found multiple diseases on multiple layers of his eyes.    No treatment information was provided.  It was reported that within 24hrs of receiving the 3rd dose patient was bedridden  Company comment- Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded.   This case was linked to MOD-2021-292150 (Patient Link).; Sender's Comments: Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded.
Age: 61.0
Sex: M
Vaccine: COVID19
Symptoms: Bedridden, Blindness, Diplopia, Pain, Photophobia
Clinical narrative: legally blind in both eyes; bedridden; extreme light sensitivity; had double & triple vision; in pain; This spontaneous case was reported by a consumer and describes the occurrence of BLINDNESS (legally blind in both eyes) in a 61-year-old male 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 reported history provided by the reporter.  Concomitant products included PREDNISONE for an unknown indication.   On 27-Jan-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 BLINDNESS (legally blind in both eyes) (seriousness criterion medically significant), BEDRIDDEN (bedridden), PHOTOPHOBIA (extreme light sensitivity), DIPLOPIA (had double & triple vision) and PAIN (in pain). At the time of the report, BLINDNESS (legally blind in both eyes), BEDRIDDEN (bedridden), PHOTOPHOBIA (extreme light sensitivity), DIPLOPIA (had double & triple vision) and PAIN (in pain) outcome was unknown.      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.   Patient had a history of bletherakaretoconjuntivitis, and uvetitis among many other diseases dating back to 30 years. Patient went to two different hospitals and a another major eye clinic for treatment after the 2nd shot & they never connected it with the vaccine.  They found multiple diseases on multiple layers of his eyes.  Treatment medication was  not reported. Company Comment: Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded.  However, patient's underlying disease (history of eye problem) remains a contributory factor.   This case was linked to MOD-2021-292109 (Patient Link).; Sender's Comments: Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded.  However, patient's underlying disease (history of eye problem) remains a contributory factor.
Age: 76.0
Sex: F
Vaccine: COVID19
Symptoms: Peripheral swelling, Product dose omission issue, Vaccination site pain, Vaccination site pruritus
Clinical narrative: arm swelled from my elbow to my shoulder; injection site arm itched; injection site left arm is sore; Physician told me not to receive the second Moderna Covid-19 vaccine; This spontaneous case was reported by a consumer and describes the occurrence of PERIPHERAL SWELLING (arm swelled from my elbow to my shoulder), VACCINATION SITE PRURITUS (injection site arm itched), VACCINATION SITE PAIN (injection site left arm is sore) and PRODUCT DOSE OMISSION ISSUE (Physician told me not to receive the second Moderna Covid-19 vaccine) in a 76-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On 05-Aug-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced PERIPHERAL SWELLING (arm swelled from my elbow to my shoulder), VACCINATION SITE PRURITUS (injection site arm itched), VACCINATION SITE PAIN (injection site left arm is sore) and PRODUCT DOSE OMISSION ISSUE (Physician told me not to receive the second Moderna Covid-19 vaccine). At the time of the report, PERIPHERAL SWELLING (arm swelled from my elbow to my shoulder), VACCINATION SITE PRURITUS (injection site arm itched) and VACCINATION SITE PAIN (injection site left arm is sore) outcome was unknown and PRODUCT DOSE OMISSION ISSUE (Physician told me not to receive the second Moderna Covid-19 vaccine) had resolved.        mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was withdrawn on 05-Aug-2021.       Concomitant medication of the patient was not reported.  The patient went to urgent care and an allergic reaction to the Moderna COVID-19 vaccine is confirmed. The patient was given a steroid cream to put on the arm.  Company Comment: Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded. Further information is expected.; Sender's Comments: Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded.  Further information is  expected.
Age: 19.0
Sex: M
Vaccine: COVID19
Symptoms: Anaphylactic shock
Clinical narrative: Anaphylactic Shock; This spontaneous case was reported by a consumer and describes the occurrence of ANAPHYLACTIC SHOCK (Anaphylactic Shock) in a 19-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 016B21A) for COVID-19 vaccination.     Concurrent medical conditions included Allergy to molds and Allergy NOS (other things).    On 31-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 31-Mar-2021, the patient experienced ANAPHYLACTIC SHOCK (Anaphylactic Shock) (seriousness criterion medically significant). On 31-Mar-2021, ANAPHYLACTIC SHOCK (Anaphylactic Shock) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       Concomitant product use was not provided by the reporter.   One minute after vaccination, he was in anaphylactic shock.   No treatment information was provided.  Based on the current available information and temporal association between the use of the product and the start date of the event, a causal relationship cannot be excluded.   This case was linked to INC.-MOD-2021-132953 (E2B Linked Report).; Sender's Comments: Based on the current available information and temporal association between the use of the product and the start date of the event, a causal relationship cannot be excluded. INC.-MOD-2021-132953: