chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 61.0
Sex: F
Vaccine: COVID19
Symptoms: Chills, Decreased appetite, Fatigue, Nausea, Pyrexia
Clinical narrative: Redness appeared by the injection site, half way down to the elbow; Loss of appetite; 101F fever lasted three days; chills; Fatigue; Nausea; This spontaneous case was reported by a consumer and describes the occurrence of DECREASED APPETITE (Loss of appetite), PYREXIA (101F fever lasted three days), CHILLS (chills), FATIGUE (Fatigue) and NAUSEA (Nausea) in a 61-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 038A21A and 006M20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     The patient's past medical history included Chemotherapy NOS from 2003 to 2004 and Crohn's disease. Concurrent medical conditions included Osteoporosis, Small fiber neuropathy (Autonomic small fiber Neuropathy) and Diastolic heart failure. Concomitant products included VEDOLIZUMAB (ENTYVIO) and PYRIDOSTIGMINE for an unknown indication.   On 14-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 14-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 DECREASED APPETITE (Loss of appetite), PYREXIA (101F fever lasted three days), CHILLS (chills), FATIGUE (Fatigue), NAUSEA (Nausea) and VACCINATION SITE ERYTHEMA (Redness appeared by the injection site, half way down to the elbow). At the time of the report, DECREASED APPETITE (Loss of appetite), PYREXIA (101F fever lasted three days), CHILLS (chills), FATIGUE (Fatigue) and NAUSEA (Nausea) outcome was unknown and VACCINATION SITE ERYTHEMA (Redness appeared by the injection site, half way down to the elbow) had resolved.            No treatment medications were provided Patient stated that - redness pretty much went away week and a half later   This case was linked to MOD-2021-289115 (Patient Link).
Age: 61.0
Sex: F
Vaccine: COVID19
Symptoms: Vaccination site erythema
Clinical narrative: Redness appeared by the injection site, half way down to the elbow; Loss of appetite; 101F fever lasted three days; chills; Fatigue; Nausea; This spontaneous case was reported by a consumer and describes the occurrence of DECREASED APPETITE (Loss of appetite), PYREXIA (101F fever lasted three days), CHILLS (chills), FATIGUE (Fatigue) and NAUSEA (Nausea) in a 61-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 038A21A and 006M20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     The patient's past medical history included Chemotherapy NOS from 2003 to 2004 and Crohn's disease. Concurrent medical conditions included Osteoporosis, Small fiber neuropathy (Autonomic small fiber Neuropathy) and Diastolic heart failure. Concomitant products included VEDOLIZUMAB (ENTYVIO) and PYRIDOSTIGMINE for an unknown indication.   On 14-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 14-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 DECREASED APPETITE (Loss of appetite), PYREXIA (101F fever lasted three days), CHILLS (chills), FATIGUE (Fatigue), NAUSEA (Nausea) and VACCINATION SITE ERYTHEMA (Redness appeared by the injection site, half way down to the elbow). At the time of the report, DECREASED APPETITE (Loss of appetite), PYREXIA (101F fever lasted three days), CHILLS (chills), FATIGUE (Fatigue) and NAUSEA (Nausea) outcome was unknown and VACCINATION SITE ERYTHEMA (Redness appeared by the injection site, half way down to the elbow) had resolved.            No treatment medications were provided Patient stated that - redness pretty much went away week and a half later   This case was linked to MOD-2021-289115 (Patient Link).
Sex: U
Vaccine: COVID19
Symptoms: Vaccination site induration, Vaccination site swelling
Clinical narrative: injected part if kinda hardened; injected part if kinda hardened almost to swelling; This case was received via an unknown source (no reference has been entered for a health authority or license partner) on 17-Aug-2021 and was forwarded to Moderna on 17-Aug-2021.    This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE INDURATION (injected part if kinda hardened) and VACCINATION SITE SWELLING (injected part if kinda hardened almost to swelling) in a patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On an unknown date, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced VACCINATION SITE INDURATION (injected part if kinda hardened) and VACCINATION SITE SWELLING (injected part if kinda hardened almost to swelling). At the time of the report, VACCINATION SITE INDURATION (injected part if kinda hardened) and VACCINATION SITE SWELLING (injected part if kinda hardened almost to swelling) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       Concomitant product information was not provided. Treatment information was not provided.   Reporter did not allow further contact
Sex: U
Vaccine: COVID19
Symptoms: Pyrexia
Clinical narrative: Fever; This spontaneous case was reported by a consumer and describes the occurrence of PYREXIA (Fever) in a patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On an unknown date, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced PYREXIA (Fever). At the time of the report, PYREXIA (Fever) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No treatment medications were provided. No concomitant medications were provided.   Reporter did not allow further contact
Sex: U
Vaccine: COVID19
Symptoms: Body temperature, Flushing, Myalgia, Nausea, Pyrexia
Clinical narrative: Flush; Body aches; Nausea; 99.5 is the highest temp; This spontaneous case was reported by a consumer and describes the occurrence of FLUSHING (Flush), MYALGIA (Body aches), NAUSEA (Nausea) and PYREXIA (99.5 is the highest temp) 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 16-Aug-2021, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 17-Aug-2021, the patient experienced FLUSHING (Flush), MYALGIA (Body aches), NAUSEA (Nausea) and PYREXIA (99.5 is the highest temp). At the time of the report, FLUSHING (Flush), MYALGIA (Body aches), NAUSEA (Nausea) and PYREXIA (99.5 is the highest temp) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 17-Aug-2021, Body temperature: 99.5 (High) High.     The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No concomitant medication information was provided. No treatment medication information was provided.   Reporter did not allow further contact
Age: 38.0
Sex: F
Vaccine: COVID19
Symptoms: Product dose omission issue
Clinical narrative: No second dose; This spontaneous case was reported by a consumer and describes the occurrence of PRODUCT DOSE OMISSION ISSUE (No second dose) in a 38-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On 15-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced PRODUCT DOSE OMISSION ISSUE (No second dose). At the time of the report, PRODUCT DOSE OMISSION ISSUE (No second dose) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No concomitant medication reported. No treatment medication provided. The patient had to leave the country and had missed the second dose.
Age: 59.0
Sex: M
Vaccine: COVID19
Symptoms: Bell's palsy, Condition aggravated
Clinical narrative: His Bell's palsy was worse than it ever was/the 1st dose of the vaccine "jacked up" his Bell's palsy; Condition aggravated; This spontaneous case was reported by a consumer and describes the occurrence of BELL'S PALSY (His Bell's palsy was worse than it ever was/the 1st dose of the vaccine "jacked up" his Bell's palsy) in a 59-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 011A21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     The patient's past medical history included Liver transplant. Concurrent medical conditions included Bell's palsy since June 2021. Concomitant products included TACROLIMUS (PROGRAF), LISINOPRIL and GABAPENTIN 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. In February 2021, the patient experienced BELL'S PALSY (His Bell's palsy was worse than it ever was/the 1st dose of the vaccine "jacked up" his Bell's palsy) (seriousness criterion medically significant) and CONDITION AGGRAVATED (Condition aggravated). At the time of the report, BELL'S PALSY (His Bell's palsy was worse than it ever was/the 1st dose of the vaccine "jacked up" his Bell's palsy) and CONDITION AGGRAVATED (Condition aggravated) outcome was unknown.            Concomitant medication included Etdir. Treatment information included Gabapentin.  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. Of note, the patient has a past condition of Bell's Palsy.  This is limited information has been provided at this time further information is expected   This case was linked to MOD-2021-290260 (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. Of note, the patient has a past condition of Bell's Palsy.  This is very limited information has been provided at this time further information is expected
Age: 86.0
Sex: F
Vaccine: COVID19
Symptoms: Decreased appetite, Extra dose administered, Retching
Clinical narrative: she does not have an appetite; she cannot eat/she gags whenever she tries to eat; Patient received her booster (3rd dose) of the Moderna Covid-19 Vaccine; This spontaneous case was reported by a consumer and describes the occurrence of DECREASED APPETITE (she does not have an appetite), RETCHING (she cannot eat/she gags whenever she tries to eat) and EXTRA DOSE ADMINISTERED (Patient received her booster (3rd dose) of the Moderna Covid-19 Vaccine) in an 86-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 053E21A) for COVID-19 vaccination.     The patient's past medical history included Heart attack (Patient disclosed  that she had a heart attack in the past so she was on a lot of medications.). Concomitant products included ATORVASTATIN, CARVEDILOL, MELATONIN, NITROFURANTOIN, ACETYLSALICYLIC ACID (ASPIRINE), TICAGRELOR (BRILINTA), SACUBITRIL VALSARTAN SODIUM HYDRATE (ENTRESTO) and BIFIDOBACTERIUM LONGUM, LACTOBACILLUS ACIDOPHILUS, LACTOBACILLUS RHAMNOSUS (PROBIOTICS [BIFIDOBACTERIUM LONGUM;LACTOBACILLUS ACIDOPHILUS;LACTOBACILLUS RHAMNOSUS]) for an unknown indication.   On 16-Aug-2021, the patient 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 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 16-Aug-2021, the patient experienced EXTRA DOSE ADMINISTERED (Patient received her booster (3rd dose) of the Moderna Covid-19 Vaccine). On 17-Aug-2021, the patient experienced DECREASED APPETITE (she does not have an appetite) and RETCHING (she cannot eat/she gags whenever she tries to eat). At the time of the report, DECREASED APPETITE (she does not have an appetite) and RETCHING (she cannot eat/she gags whenever she tries to eat) outcome was unknown and EXTRA DOSE ADMINISTERED (Patient received her booster (3rd dose) of the Moderna Covid-19 Vaccine) had resolved.            The treatment information was unknown.
Age: 38.0
Sex: M
Vaccine: COVID19
Symptoms: Product dose omission issue
Clinical narrative: Second dose has not been administered more than 2 months away from the first dose; This spontaneous case was reported by a nurse and describes the occurrence of PRODUCT DOSE OMISSION ISSUE (Second dose has not been administered more than 2 months away from the first dose) in a 38-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On 02-Jun-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 17-Aug-2021, the patient experienced PRODUCT DOSE OMISSION ISSUE (Second dose has not been administered more than 2 months away from the first dose). At the time of the report, PRODUCT DOSE OMISSION ISSUE (Second dose has not been administered more than 2 months away from the first dose) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   No concomitant medications were reported No treatment information was reported.
Age: 12.0
Sex: M
Vaccine: COVID19
Symptoms: Hyperhidrosis, Product administered to patient of inappropriate age, Pyrexia
Clinical narrative: Excessive sweating; Feeling feverish; Moderna Covid-19 vaccine administered to a 12 year old; This spontaneous case was reported by a consumer and describes the occurrence of HYPERHIDROSIS (Excessive sweating), PRODUCT ADMINISTERED TO PATIENT OF INAPPROPRIATE AGE (Moderna Covid-19 vaccine administered to a 12 year old) and PYREXIA (Feeling feverish) in a 12-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 051C21A) for COVID-19 vaccination.     No Medical History information was reported.    On 15-Jul-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 15-Jul-2021,  after starting mRNA-1273 (Moderna COVID-19 Vaccine), the patient experienced PRODUCT ADMINISTERED TO PATIENT OF INAPPROPRIATE AGE (Moderna Covid-19 vaccine administered to a 12 year old). On 24-Jul-2021, the patient experienced HYPERHIDROSIS (Excessive sweating). 24-Jul-2021, the patient experienced PYREXIA (Feeling feverish). On 15-Jul-2021, PRODUCT ADMINISTERED TO PATIENT OF INAPPROPRIATE AGE (Moderna Covid-19 vaccine administered to a 12 year old) had resolved. At the time of the report, HYPERHIDROSIS (Excessive sweating) and PYREXIA (Feeling feverish) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No concomitant drugs were provided No treatment drugs were provided.  The patient said that she brought her son to the pharmacy and the Pharmacy Technician asked the Mother if her son who was 12 years of age would like the Pfizer or the Moderna Covid-19 vaccine.. The callers son received his first Moderna Covid-19 dose on 15-Jul-2021.
Age: 59.0
Sex: M
Vaccine: COVID19
Symptoms: Deep vein thrombosis
Clinical narrative: patient suffered a DVT; This spontaneous case was reported by a pharmacist and describes the occurrence of DEEP VEIN THROMBOSIS (patient suffered a DVT) in a 59-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 003C21A and 003B21A) for COVID-19 vaccination.     Concomitant products included ANTICOAGULANT CITRATE DEXTROSE (ANTICOAGULATION) and APIXABAN (ELIQUIS) for an unknown indication.   On 07-May-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 08-Jun-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 28-May-2021, the patient experienced DEEP VEIN THROMBOSIS (patient suffered a DVT) (seriousness criterion medically significant). At the time of the report, DEEP VEIN THROMBOSIS (patient suffered a DVT) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   Laboratory data was mentioned as the ultrasound  and result was not given. No treatment information was provided by the reporter.  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 has been requested.; 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 has been requested.
Age: 61.0
Sex: F
Vaccine: COVID19
Symptoms: Abdominal discomfort, Dizziness, Headache, Nausea
Clinical narrative: Stomach was upset like nausea; Lightheaded/ somewhat dizzy; Headaches; Nausea; This case was received via an unknown source (no reference has been entered for a health authority or license partner) on 17-Aug-2021 and was forwarded to Moderna on 17-Aug-2021.    This spontaneous case was reported by a consumer and describes the occurrence of ABDOMINAL DISCOMFORT (Stomach was upset like nausea), DIZZINESS (Lightheaded/ somewhat dizzy), HEADACHE (Headaches) and NAUSEA (Nausea) in a 61-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     Concurrent medical conditions included Chronic kidney disease stage 3 and Spinal stenosis. Concomitant products included TRAMADOL for an unknown indication.    On 25-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced ABDOMINAL DISCOMFORT (Stomach was upset like nausea), DIZZINESS (Lightheaded/ somewhat dizzy), HEADACHE (Headaches) and NAUSEA (Nausea). At the time of the report, ABDOMINAL DISCOMFORT (Stomach was upset like nausea), DIZZINESS (Lightheaded/ somewhat dizzy), HEADACHE (Headaches) and NAUSEA (Nausea) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       Patient stated she did not take any medications for her symptoms but limited her diet to applesauce, bananas and rice.   This case was linked to MOD-2021-289628 (Patient Link).
Sex: U
Vaccine: COVID19
Symptoms: COVID-19, SARS-CoV-2 test
Clinical narrative: got Covid; This spontaneous case was reported by a consumer and describes the occurrence of COVID-19 (got Covid) 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 22-Jul-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 31-Jul-2021, the patient experienced COVID-19 (got Covid). At the time of the report, COVID-19 (got Covid) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 31-Jul-2021, SARS-CoV-2 test: positive (Positive) Positive.     The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No concomitant medications details were provided.  No treatment Medications details were provided.
Age: 57.0
Sex: F
Vaccine: COVID19
Symptoms: Influenza like illness
Clinical narrative: Flu like symptoms; This spontaneous case was reported by a consumer and describes the occurrence of INFLUENZA LIKE ILLNESS (Flu like symptoms) in a 57-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 030M21A) for COVID-19 vaccination.     The patient's past medical history included Lymph node excision. Concurrent medical conditions included Breast cancer.    On 12-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 12-Feb-2021, the patient experienced INFLUENZA LIKE ILLNESS (Flu like symptoms). On 14-Feb-2021, INFLUENZA LIKE ILLNESS (Flu like symptoms) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Patient mentioned that the first dose was administered in her left arm, and as a cancer survivor, she does no receive anything in that arm, she has no lymph nodes on that side. Concomitant medications were not reported by the reporter Treatment drugs were not reported by the reporter   This case was linked to MOD-2021-289632 (Patient Link).   Most recent FOLLOW-UP information incorporated above includes: On 18-Aug-2021: Follow Up information was received on 18-Aug-2021 and Added DOB/age of patient.
Age: 76.0
Sex: M
Vaccine: COVID19
Symptoms: Dyspnoea, Intentional product use issue
Clinical narrative: short of breath; greater than 35 days between Covid-19 vaccinations; This spontaneous case was reported by a pharmacist and describes the occurrence of DYSPNOEA (short of breath) and INTENTIONAL PRODUCT USE ISSUE (greater than 35 days between Covid-19 vaccinations) in a 76-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 003T21A) for COVID-19 vaccination.     No Medical History information was reported.    On 04-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 DYSPNOEA (short of breath) and INTENTIONAL PRODUCT USE ISSUE (greater than 35 days between Covid-19 vaccinations). At the time of the report, DYSPNOEA (short of breath) outcome was unknown and INTENTIONAL PRODUCT USE ISSUE (greater than 35 days between Covid-19 vaccinations) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   No concomitant medications were reported.  No treatment medications were reported.
Sex: M
Vaccine: COVID19
Symptoms: Erythema
Clinical narrative: Red marks on skin following vaccination; This spontaneous case was reported by a consumer and describes the occurrence of ERYTHEMA (Red marks on skin following vaccination) 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 07-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 ERYTHEMA (Red marks on skin following vaccination). At the time of the report, ERYTHEMA (Red marks on skin following vaccination) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No Concomitant Medication was provided.   No treatment information was provided.
Sex: U
Vaccine: COVID19
Symptoms: Toxicity to various agents
Clinical narrative: it's toxic; 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 TOXICITY TO VARIOUS AGENTS (it's toxic) 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 TOXICITY TO VARIOUS AGENTS (it's toxic). At the time of the report, TOXICITY TO VARIOUS AGENTS (it's toxic) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       Concomitant medications were not provided.  Treatment information was not reported.  Other countries stopped giving the Moderna and Pfizer's vaccine because it's toxic.   This case was linked to MOD21-131922 (E2B Linked Report).; Sender's Comments:  MOD21-131922:
Sex: F
Vaccine: COVID19
Symptoms: Rash, Vaccination site mass
Clinical narrative: a little rash; on my left arm, small bumps started to populate all over; This spontaneous case was reported by a consumer and describes the occurrence of RASH (a little rash) and VACCINATION SITE MASS (on my left arm, small bumps started to populate all over) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 051C21A and 051C21A) for COVID-19 vaccination.     No Medical History information was reported.   On 01-Jul-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 29-Jul-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 RASH (a little rash) and VACCINATION SITE MASS (on my left arm, small bumps started to populate all over). The patient was treated with ACETYLSALICYLIC ACID (ASPIRIN 81) on 11-Aug-2021 at an unspecified dose and frequency. At the time of the report, RASH (a little rash) and VACCINATION SITE MASS (on my left arm, small bumps started to populate all over) outcome was unknown.        No concomitant drug information provided.  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.. The company physician considers the reported events as non-serious, because there is no apparent rationale to deal them as serious.   This case was linked to MOD-2021-289677 (Patient Link).   Reporter did not allow further contact   Most recent FOLLOW-UP information incorporated above includes: On 17-Aug-2021: Follow up received contain no new information.; 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.. The company physician considers the reported events as non-serious, because there is no apparent rationale to deal them as serious
Age: 78.0
Sex: M
Vaccine: COVID19
Symptoms: Haemoglobin, Haemoglobin decreased, Hiatus hernia, Pulmonary embolism
Clinical narrative: Pulmonary embolism/blood clot in his lungs; Hiatal hernia; Hemoglobin was down to 5; This spontaneous case was reported by a consumer and describes the occurrence of PULMONARY EMBOLISM (Pulmonary embolism/blood clot in his lungs) in a 78-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 014M20A and 025A21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.   The patient's past medical history included Hip surgery and Blood transfusion.  On 27-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 27-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 PULMONARY EMBOLISM (Pulmonary embolism/blood clot in his lungs) (seriousness criteria medically significant and life threatening), HIATUS HERNIA (Hiatal hernia) and HAEMOGLOBIN DECREASED (Hemoglobin was down to 5). The patient was treated with APIXABAN (ELIQUIS) at an unspecified dose and frequency. At the time of the report, PULMONARY EMBOLISM (Pulmonary embolism/blood clot in his lungs), HIATUS HERNIA (Hiatal hernia) and HAEMOGLOBIN DECREASED (Hemoglobin was down to 5) outcome was unknown.  DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, Haemoglobin: 5 (Low) hemoglobin was down to 5.  Concomitant product use was not provided by the reporter. The patient stated that he had a pulmonary embolism after his hip surgery and was placed on Eliquis. After 6 months while taking Eliquis he developed a blood clot in his lungs and was placed on Eliquis for life. This last week he went in for some blood tests and his hemoglobin was down to 5. He was given 3 units of blood by transfusion.  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. Thromboembolic events are one of the AESI in the use of the product  Patient will continue to be monitored. 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. Thromboembolic events are one of the AESI in the use of the product  Patient will continue to be monitored. Further information is expected.
Sex: F
Vaccine: COVID19
Symptoms: Bronchitis, COVID-19, Pneumonia, Product dose omission issue
Clinical narrative: Pneumonia; Bronchitis; COVID-19 Positive; Missed the recommended interval between doses; This spontaneous case was reported by a consumer and describes the occurrence of PNEUMONIA (Pneumonia) 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.     No Medical History information was reported.    In January 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 PNEUMONIA (Pneumonia) (seriousness criterion medically significant), BRONCHITIS (Bronchitis), COVID-19 (COVID-19 Positive) and PRODUCT DOSE OMISSION ISSUE (Missed the recommended interval between doses). At the time of the report, PNEUMONIA (Pneumonia), BRONCHITIS (Bronchitis) and COVID-19 (COVID-19 Positive) outcome was unknown and PRODUCT DOSE OMISSION ISSUE (Missed the recommended interval between doses) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No relevant concomitant medications were reported. Treatment information reported that, the patient got infusion in the hospital.  Company comment: Very limited information regarding this event/s has been provided at this time.  Further information has been requested.; Sender's Comments: Very limited information regarding this event/s has been provided at this time.  Further information has been requested.
Sex: U
Vaccine: COVID19
Symptoms: Death
Clinical narrative: People that died; 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 DEATH (People that died) 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. Death occurred on an unknown date The cause of death was not reported. It is unknown if an autopsy was performed.            The concomitant medications were not reported. The treatment information was not provided.   Company Comment : This case cannot be evaluated, it seems invalid. More info has been required to assess its validity.; Sender's Comments: This case cannot be evaluated, it seems invalid. More info has been required to assess its validity.; Reported Cause(s) of Death: Unknown cause of death
Age: 45.0
Sex: F
Vaccine: COVID19
Symptoms: Myalgia, Vaccination site pain
Clinical narrative: sore arm; mild body aches; This spontaneous case was reported by an other health care professional and describes the occurrence of VACCINATION SITE PAIN (sore arm) and MYALGIA (mild body aches) in a 45-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 032L20A /) for COVID-19 vaccination.     No Medical History information was reported.    On 21-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 VACCINATION SITE PAIN (sore arm) and MYALGIA (mild body aches). At the time of the report, VACCINATION SITE PAIN (sore arm) and MYALGIA (mild body aches) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown Route) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown Route), the reporter did not provide any causality assessments.   No concomitant medications were provided. No treatment information was provided.   This case was linked to MOD-2021-289960 (Patient Link).
Age: 69.0
Sex: F
Vaccine: COVID19
Symptoms: Vaccination site pain
Clinical narrative: sore right injection site shoulder; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE PAIN (sore right injection site shoulder) in a 70-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 047A21A and 030A21A) for COVID-19 vaccination.     No Medical History information was reported.   On 03-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 31-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 31-Mar-2021,  after starting mRNA-1273 (Moderna COVID-19 Vaccine), the patient experienced VACCINATION SITE PAIN (sore right injection site shoulder). At the time of the report, VACCINATION SITE PAIN (sore right injection site shoulder) outcome was unknown.            Concomitant medication of the patient was not reported.  No treatment information was provided by the reporter.  The patient received her vaccine in the right arm shoulder deltoid muscle.   This case was linked to MOD-2021-289814 (Patient Link).
Age: 70.0
Sex: M
Vaccine: COVID19
Symptoms: Urticaria
Clinical narrative: Developed hives after the second dose and has been fighting them for about 4 months now that have not gone away; This spontaneous case was reported by a consumer and describes the occurrence of URTICARIA (Developed hives after the second dose and has been fighting them for about 4 months now that have not gone away) in a 70-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 012Y20A and 027L20A) for COVID-19 vaccination.     No Medical History information was reported.   On 08-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 03-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient experienced URTICARIA (Developed hives after the second dose and has been fighting them for about 4 months now that have not gone away). At the time of the report, URTICARIA (Developed hives after the second dose and has been fighting them for about 4 months now that have not gone away) had not resolved.            Concomitant product use was not provided by the reporter.  The patient developed hives 3 1/2 months ago after the second dose.  Treatment information was not provided.
Age: 65.0
Sex: M
Vaccine: COVID19
Symptoms: Fatigue, Headache, Myalgia, Pain
Clinical narrative: body ache; started to feel real fatigued; muscle aches; had a headache; This spontaneous case was reported by a consumer and describes the occurrence of PAIN (body ache), FATIGUE (started to feel real fatigued), MYALGIA (muscle aches) and HEADACHE (had a headache) in a 65-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 939902) for COVID-19 vaccination.     The patient's past medical history included COVID-19 in September 2020. Concomitant products included VITAMINS NOS and KRILL OIL for an unknown indication.    On 15-Aug-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 16-Aug-2021, the patient experienced PAIN (body ache), FATIGUE (started to feel real fatigued), MYALGIA (muscle aches) and HEADACHE (had a headache). On 17-Aug-2021, PAIN (body ache), FATIGUE (started to feel real fatigued), MYALGIA (muscle aches) and HEADACHE (had a headache) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Treatment information was not provided.
Sex: F
Vaccine: COVID19
Symptoms: Autoimmune disorder, Inflammation
Clinical narrative: flared up her autoimmune disorder; Inflammation for a couple of weeks after the second dose; This spontaneous case was reported by a consumer and describes the occurrence of AUTOIMMUNE DISORDER (flared up her autoimmune disorder) 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 Polymyalgia rheumatica (She is an immunocompromised patient who has Polymyalgia Rheumatica). Concomitant products included PREDNISONE ACETATE (PREDNISONE [PREDNISONE ACETATE]) for Polymyalgia rheumatica.    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 AUTOIMMUNE DISORDER (flared up her autoimmune disorder) (seriousness criterion medically significant) and INFLAMMATION (Inflammation for a couple of weeks after the second dose). At the time of the report, AUTOIMMUNE DISORDER (flared up her autoimmune disorder) and INFLAMMATION (Inflammation for a couple of weeks after the second dose) outcome was unknown.            Treatment medication was not provided.; 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: M
Vaccine: COVID19
Symptoms: Asymptomatic COVID-19, Drug ineffective
Clinical narrative: tested positive for COVID/ no symptoms; lack of efficacy; This spontaneous case was reported by a consumer and describes the occurrence of ASYMPTOMATIC COVID-19 (tested positive for COVID/ no symptoms) and DRUG INEFFECTIVE (lack of efficacy) in a male patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 045A21A and 023M20A) for COVID-19 vaccination.   Concurrent medical conditions included Hepatitis B and Fracture. Concomitant products included TENOFOVIR DISOPROXIL FUMARATE (VIREAD), CLONIDINE (CATAPRESS) and OXYCODONE HYDROCHLORIDE, OXYCODONE TEREPHTHALATE, PARACETAMOL (PERCOCET [OXYCODONE HYDROCHLORIDE;OXYCODONE TEREPHTHALATE;PARACETAMOL]) for an unknown indication.   On 18-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 15-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 03-Aug-2021, the patient experienced ASYMPTOMATIC COVID-19 (tested positive for COVID/ no symptoms) and DRUG INEFFECTIVE (lack of efficacy). At the time of the report, ASYMPTOMATIC COVID-19 (tested positive for COVID/ no symptoms) and DRUG INEFFECTIVE (lack of efficacy) outcome was unknown.         The patient was very pleased with the vaccine. Treatment information was not provided.
Age: 45.0
Sex: F
Vaccine: COVID19
Symptoms: Arthralgia, Body temperature, Delirium, Fatigue, Hyperhidrosis
Clinical narrative: Delirious; Can barely move; arm, foot, hand and toe has been ach; Sweats; body aches; hip has been achy; Nausea; Fatigue/extreme exhaustion; 102 Fever; This spontaneous case was reported by an other health care professional and describes the occurrence of DELIRIUM (Delirious) in an adult female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 032L20A and 024M20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.   On 21-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 18-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient experienced DELIRIUM (Delirious) (seriousness criterion medically significant), MOBILITY DECREASED (Can barely move), PAIN IN EXTREMITY (arm, foot, hand and toe has been ach), HYPERHIDROSIS (Sweats), MYALGIA (body aches), ARTHRALGIA (hip has been achy), NAUSEA (Nausea), FATIGUE (Fatigue/extreme exhaustion) and PYREXIA (102 Fever). At the time of the report, DELIRIUM (Delirious), MOBILITY DECREASED (Can barely move), PAIN IN EXTREMITY (arm, foot, hand and toe has been ach), HYPERHIDROSIS (Sweats), MYALGIA (body aches), ARTHRALGIA (hip has been achy), NAUSEA (Nausea), FATIGUE (Fatigue/extreme exhaustion) and PYREXIA (102 Fever) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, Body temperature: 102 (High) High.     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.  No treatment information was provided.  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. The event of delirium was assessed as serious by IME list. Further information will not be received as there is no contact information.   This case was linked to MOD-2021-289827 (Patient Link).   Reporter did not allow further contact; 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. The event of delirium was assessed as serious by IME list. Further information will not be received as there is no contact information.
Age: 45.0
Sex: F
Vaccine: COVID19
Symptoms: Mobility decreased, Myalgia, Nausea, Pain in extremity, Pyrexia
Clinical narrative: Delirious; Can barely move; arm, foot, hand and toe has been ach; Sweats; body aches; hip has been achy; Nausea; Fatigue/extreme exhaustion; 102 Fever; This spontaneous case was reported by an other health care professional and describes the occurrence of DELIRIUM (Delirious) in an adult female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 032L20A and 024M20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.   On 21-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 18-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient experienced DELIRIUM (Delirious) (seriousness criterion medically significant), MOBILITY DECREASED (Can barely move), PAIN IN EXTREMITY (arm, foot, hand and toe has been ach), HYPERHIDROSIS (Sweats), MYALGIA (body aches), ARTHRALGIA (hip has been achy), NAUSEA (Nausea), FATIGUE (Fatigue/extreme exhaustion) and PYREXIA (102 Fever). At the time of the report, DELIRIUM (Delirious), MOBILITY DECREASED (Can barely move), PAIN IN EXTREMITY (arm, foot, hand and toe has been ach), HYPERHIDROSIS (Sweats), MYALGIA (body aches), ARTHRALGIA (hip has been achy), NAUSEA (Nausea), FATIGUE (Fatigue/extreme exhaustion) and PYREXIA (102 Fever) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, Body temperature: 102 (High) High.     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.  No treatment information was provided.  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. The event of delirium was assessed as serious by IME list. Further information will not be received as there is no contact information.   This case was linked to MOD-2021-289827 (Patient Link).   Reporter did not allow further contact; 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. The event of delirium was assessed as serious by IME list. Further information will not be received as there is no contact information.
Sex: M
Vaccine: COVID19
Symptoms: Dementia
Clinical narrative: possible unset of dementia following vaccination; This spontaneous case was reported by a consumer and describes the occurrence of DEMENTIA (possible unset of dementia following vaccination) in a male patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.   On an unknown date, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient experienced DEMENTIA (possible unset of dementia following vaccination) (seriousness criterion medically significant). At the time of the report, DEMENTIA (possible unset of dementia following vaccination) outcome was unknown.            Concomitant medications were not reported. Treatment medications were not reported.  Patient lost his vaccination card because of him suffering dementia. He had received two doses of the Moderna COVID19 vaccine and she was looking for assistance on how to get the booster dose.  Company Comment: Very limited information regarding the events has been provided at this time. Further information has been requested.; Sender's Comments: Very limited information regarding the events has been provided at this time. Further information has been requested.