chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 30.0
Sex: M
Vaccine: COVID19
Symptoms: Bedridden, Body temperature, Myalgia, Nausea, Pyrexia
Clinical narrative: Has been in bed all day; Aches; Nausea; Fever of 101.4; This spontaneous case was reported by a nurse and describes the occurrence of BEDRIDDEN (Has been in bed all day), MYALGIA (Aches), NAUSEA (Nausea) and PYREXIA (Fever of 101.4) in a 30-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On an unknown date, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced BEDRIDDEN (Has been in bed all day), MYALGIA (Aches), NAUSEA (Nausea) and PYREXIA (Fever of 101.4). At the time of the report, BEDRIDDEN (Has been in bed all day), MYALGIA (Aches), NAUSEA (Nausea) and PYREXIA (Fever of 101.4) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, Body temperature: 101.4 (High) Fever of 101.4.     For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant medication were reported.   No treatment information was provided by the reporter.   This case was linked to MOD-2021-303445, MOD-2021-303415 (Patient Link).
Age: 33.0
Sex: M
Vaccine: COVID19
Symptoms: Lymphadenopathy, Vaccination site pain
Clinical narrative: small ball on their left armpit / left armpit is swollen; little pain on the injection site; This spontaneous case was reported by a consumer and describes the occurrence of LYMPHADENOPATHY (small ball on their left armpit / left armpit is swollen) and VACCINATION SITE PAIN (little pain on the injection site) in a 33-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 053E21A) for COVID-19 vaccination.     Concurrent medical conditions included Epilepsy.    On 27-Aug-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 27-Aug-2021, the patient experienced VACCINATION SITE PAIN (little pain on the injection site). On 31-Aug-2021, the patient experienced LYMPHADENOPATHY (small ball on their left armpit / left armpit is swollen). On 28-Aug-2021, VACCINATION SITE PAIN (little pain on the injection site) had resolved. At the time of the report, LYMPHADENOPATHY (small ball on their left armpit / left armpit is swollen) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       Concomitant medication included epilepsy medication 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.
Age: 44.0
Sex: F
Vaccine: COVID19
Symptoms: Back pain, Blood test, Chest pain, Dizziness, Heart rate increased
Clinical narrative: Severe Vertigo/dizziness, rapid heart rate, chest & back pain, sweating, pain and sensitivity in lower calf  Being tested for blood clots  Results unknown at this time
Age: 44.0
Sex: F
Vaccine: COVID19
Symptoms: Hyperhidrosis, Hypersensitivity, Pain in extremity, Thrombosis, Vertigo
Clinical narrative: Severe Vertigo/dizziness, rapid heart rate, chest & back pain, sweating, pain and sensitivity in lower calf  Being tested for blood clots  Results unknown at this time
Sex: U
Vaccine: COVID19
Symptoms: Fatigue, Haematochezia, Pyrexia
Clinical narrative: Blood in my stool; Fatigue; Fever; This spontaneous case was reported by a consumer and describes the occurrence of HAEMATOCHEZIA (Blood in my stool) 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 second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 31-Aug-2021, the patient experienced FATIGUE (Fatigue) and PYREXIA (Fever). On 01-Sep-2021, the patient experienced HAEMATOCHEZIA (Blood in my stool) (seriousness criterion medically significant). At the time of the report, HAEMATOCHEZIA (Blood in my stool) outcome was unknown and FATIGUE (Fatigue) and PYREXIA (Fever) was resolving.            Concomitant product use was not provided by the reporter. No treatment information was provided.  Very limited information regarding these events have been provided at this time, unknown date of vaccination hence cannot establish temporal relationship. No further information is expected.; Sender's Comments: Very limited information regarding these events have been provided at this time, unknown date of vaccination hence cannot establish temporal relationship. No further information is expected.
Age: 63.0
Sex: F
Vaccine: COVID19
Symptoms: Vaccination site erythema, Vaccination site pruritus, Vaccination site swelling
Clinical narrative: Red left arm injection site 6" x 6" after 3rd shot/spreading/ about 6 inches long and wide/red at injection site; Swollen left arm injection site 6" x 6" after 3rd shot; Itching left arm injection site after 3rd shot; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE ERYTHEMA (Red left arm injection site 6" x 6" after 3rd shot/spreading/ about 6 inches long and wide/red at injection site), VACCINATION SITE SWELLING (Swollen left arm injection site 6" x 6" after 3rd shot) and VACCINATION SITE PRURITUS (Itching left arm injection site after 3rd shot) in a 63-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 062E21A) for COVID-19 vaccination.     The patient's past medical history included Bipolar I disorder. Concomitant products included ARIPIPRAZOLE (ABILIFY) and MACROGOL 3350 (MIRALAX) for an unknown indication.    On 29-Aug-2021, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 29-Aug-2021, the patient experienced VACCINATION SITE ERYTHEMA (Red left arm injection site 6" x 6" after 3rd shot/spreading/ about 6 inches long and wide/red at injection site), VACCINATION SITE SWELLING (Swollen left arm injection site 6" x 6" after 3rd shot) and VACCINATION SITE PRURITUS (Itching left arm injection site after 3rd shot). At the time of the report, VACCINATION SITE ERYTHEMA (Red left arm injection site 6" x 6" after 3rd shot/spreading/ about 6 inches long and wide/red at injection site), VACCINATION SITE SWELLING (Swollen left arm injection site 6" x 6" after 3rd shot) and VACCINATION SITE PRURITUS (Itching left arm injection site after 3rd shot) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   Treatment history was not reported.   This case was linked to MOD-2021-027468, MOD-2021-023570 (Patient Link).   Most recent FOLLOW-UP information incorporated above includes: On 01-Sep-2021: Follow up report contains patient demographics, Relevent medical history and concomitant medication were added. On 01-Sep-2021: follow up report contains no new information(NNI)
Age: 74.0
Sex: M
Vaccine: COVID19
Symptoms: Expired product administered, Product storage error
Clinical narrative: vaccine administered after beeing in the fridge for 40 days; it had been stored in the fridge for 40 days so 10 days over our recommended storage.; This spontaneous case was reported by a nurse and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (vaccine administered after beeing in the fridge for 40 days) and PRODUCT STORAGE ERROR (it had been stored in the fridge for 40 days so 10 days over our recommended storage.) in a 74-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 040C21A) for COVID-19 vaccination.     Concurrent medical conditions included Immunocompromised.    On 31-Aug-2021, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 31-Aug-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (vaccine administered after beeing in the fridge for 40 days) and PRODUCT STORAGE ERROR (it had been stored in the fridge for 40 days so 10 days over our recommended storage.). On 31-Aug-2021, EXPIRED PRODUCT ADMINISTERED (vaccine administered after beeing in the fridge for 40 days) and PRODUCT STORAGE ERROR (it had been stored in the fridge for 40 days so 10 days over our recommended storage.) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   Concomitant and Treatment was not specified.; Sender's Comments: This report refers to a case of product storage error and expired product administered for mRNA-1273 (batch no. 040C21A)  with no associated AEs.
Age: 72.0
Sex: F
Vaccine: COVID19
Symptoms: Expired product administered, Product storage error
Clinical narrative: Vaccine administered after beeing in the fridge for 40 days; vaccine administered after beeing in the fridge for 40 days; This spontaneous case was reported by a nurse and describes the occurrence of PRODUCT STORAGE ERROR (Vaccine administered after beeing in the fridge for 40 days) and EXPIRED PRODUCT ADMINISTERED (vaccine administered after beeing in the fridge for 40 days) in a 72-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 040C21A) for COVID-19 vaccination.     No Medical History information was reported.    On 31-Aug-2021, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 31-Aug-2021, the patient experienced PRODUCT STORAGE ERROR (Vaccine administered after beeing in the fridge for 40 days) and EXPIRED PRODUCT ADMINISTERED (vaccine administered after beeing in the fridge for 40 days). On 31-Aug-2021, PRODUCT STORAGE ERROR (Vaccine administered after beeing in the fridge for 40 days) and EXPIRED PRODUCT ADMINISTERED (vaccine administered after beeing in the fridge for 40 days) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   No concomitant and treatment medications were provided  The nurse stated that the patient was administered 3 dose being immunocompromised.; Sender's Comments: This report refers to a case of "Product storage error" and "Expired product administered" for mRNA-1273, lot # 040C21A with no associated AEs. The causality will be considered "Not Applicable "for these events.
Age: 50.0
Sex: F
Vaccine: COVID19
Symptoms: Chills, Ear haemorrhage, Fatigue, Pain, Pain in extremity
Clinical narrative: had blood inside her right ear, a lot of blood, and is bleeding very easily/ more so than she usually does / noticed blood coming out of her ears / some of it was old dried blood and some was new; sore arm; achy; fatigue; chills; This spontaneous case was reported by a consumer and describes the occurrence of EAR HAEMORRHAGE (had blood inside her right ear, a lot of blood, and is bleeding very easily/ more so than she usually does / noticed blood coming out of her ears / some of it was old dried blood and some was new), PAIN IN EXTREMITY (sore arm), PAIN (achy), FATIGUE (fatigue) and CHILLS (chills) in a 50-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 025L20A, 012M20A and 025L20A) for COVID-19 vaccination.     Concurrent medical conditions included Immunocompromised, Lupus nephritis, Heart disease, unspecified and Systemic lupus erythematosus (Patient stated that - she has Systemic Lupus and has been on prednisone for 30 years). Concomitant products included PREDNISONE, MIRTAZAPINE, ROSUVASTATIN, WARFARIN and LISINOPRIL for an unknown indication.   On 05-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 28-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 EAR HAEMORRHAGE (had blood inside her right ear, a lot of blood, and is bleeding very easily/ more so than she usually does / noticed blood coming out of her ears / some of it was old dried blood and some was new), PAIN IN EXTREMITY (sore arm), PAIN (achy), FATIGUE (fatigue) and CHILLS (chills). At the time of the report, EAR HAEMORRHAGE (had blood inside her right ear, a lot of blood, and is bleeding very easily/ more so than she usually does / noticed blood coming out of her ears / some of it was old dried blood and some was new), PAIN IN EXTREMITY (sore arm), PAIN (achy), FATIGUE (fatigue) and CHILLS (chills) outcome was unknown.            Patient states she got blood work done about 20 minutes ago to see if her clotting factor is off, she has not received her results yet.  No treatment medications provided.   This case was linked to MOD-2021-304463, MOD-2021-304558 (Patient Link).
Age: 80.0
Sex: M
Vaccine: COVID19
Symptoms: Expired product administered, Product storage error
Clinical narrative: vaccine administered after beeing in the fridge for 40 days; stored in the fridge for 40 days so 10 days over our recommended storage; This spontaneous case was reported by a nurse and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (vaccine administered after beeing in the fridge for 40 days) and PRODUCT STORAGE ERROR (stored in the fridge for 40 days so 10 days over our recommended storage) in an 80-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 040C21A) for COVID-19 vaccination.     Concurrent medical conditions included Immunocompromised.   On 31-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 31-Aug-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (vaccine administered after beeing in the fridge for 40 days) and PRODUCT STORAGE ERROR (stored in the fridge for 40 days so 10 days over our recommended storage). On 31-Aug-2021, EXPIRED PRODUCT ADMINISTERED (vaccine administered after beeing in the fridge for 40 days) and PRODUCT STORAGE ERROR (stored in the fridge for 40 days so 10 days over our recommended storage) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   Concomitant drug was not reported. Treatment medication was not reported.  It was reported that the vial was stored initially in refrigerator from 21-Aug-2021 and didn't undergo any temperature excursion. The temperature range the vaccine was exposed was 8° to 25°C= 46° to 77° F(3hrs). The vaccine was administered to 10 patients.; Sender's Comments: Product storage and administration errors are assessed as "not applicable", by convention, with respect as determined causality. No specific adverse events associated with the errors were reported
Age: 73.0
Sex: F
Vaccine: COVID19
Symptoms: Blood test, Computerised tomogram, Feeling abnormal, Feeling cold, Headache
Clinical narrative: Started to feel very heal; Felt like she had the flu; Freezing to the point that she had to put on 6 layers of clothing and thermal wear; she was running fever; Severe headache,Headache is excruciating,Headache is crushing,Sharp pain that go through her head,Today was a very bad day (regarding her headache); This spontaneous case was reported by a consumer and describes the occurrence of HEADACHE (Severe headache,Headache is excruciating,Headache is crushing,Sharp pain that go through her head,Today was a very bad day (regarding her headache)), FEELING ABNORMAL (Started to feel very heal), INFLUENZA (Felt like she had the flu), FEELING COLD (Freezing to the point that she had to put on 6 layers of clothing and thermal wear) and PYREXIA (she was running fever) in a 73-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 031B21A and 006B21A) for COVID-19 vaccination.     No Medical History information was reported.   On 24-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 21-Apr-2021 at 2:00 PM, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 21-Apr-2021 at 5:00 PM, the patient experienced FEELING ABNORMAL (Started to feel very heal), INFLUENZA (Felt like she had the flu), FEELING COLD (Freezing to the point that she had to put on 6 layers of clothing and thermal wear) and PYREXIA (she was running fever). On an unknown date, the patient experienced HEADACHE (Severe headache,Headache is excruciating,Headache is crushing,Sharp pain that go through her head,Today was a very bad day (regarding her headache)). The patient was treated with PARACETAMOL (TYLENOL) for Adverse event, at an unspecified dose and frequency and ASPIRIN [ACETYLSALICYLIC ACID] for Adverse event, at an unspecified dose and frequency. At the time of the report, HEADACHE (Severe headache,Headache is excruciating,Headache is crushing,Sharp pain that go through her head,Today was a very bad day (regarding her headache)) had not resolved and FEELING ABNORMAL (Started to feel very heal), INFLUENZA (Felt like she had the flu), FEELING COLD (Freezing to the point that she had to put on 6 layers of clothing and thermal wear) and PYREXIA (she was running fever) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, Blood test: normal (normal) Normal. On an unknown date, Computerised tomogram: normal (normal) Normal.     For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   No relevant concomitant medications were reported. Patient thought the side effect is neurological.; Sender's Comments: Based on the current available information and temporal association between the use of the product and the onset date of the events, a causal relationship cannot be excluded. Therefore, causality is assessed as possibly related.
Age: 73.0
Sex: F
Vaccine: COVID19
Symptoms: Influenza like illness, Pyrexia
Clinical narrative: Started to feel very heal; Felt like she had the flu; Freezing to the point that she had to put on 6 layers of clothing and thermal wear; she was running fever; Severe headache,Headache is excruciating,Headache is crushing,Sharp pain that go through her head,Today was a very bad day (regarding her headache); This spontaneous case was reported by a consumer and describes the occurrence of HEADACHE (Severe headache,Headache is excruciating,Headache is crushing,Sharp pain that go through her head,Today was a very bad day (regarding her headache)), FEELING ABNORMAL (Started to feel very heal), INFLUENZA (Felt like she had the flu), FEELING COLD (Freezing to the point that she had to put on 6 layers of clothing and thermal wear) and PYREXIA (she was running fever) in a 73-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 031B21A and 006B21A) for COVID-19 vaccination.     No Medical History information was reported.   On 24-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 21-Apr-2021 at 2:00 PM, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 21-Apr-2021 at 5:00 PM, the patient experienced FEELING ABNORMAL (Started to feel very heal), INFLUENZA (Felt like she had the flu), FEELING COLD (Freezing to the point that she had to put on 6 layers of clothing and thermal wear) and PYREXIA (she was running fever). On an unknown date, the patient experienced HEADACHE (Severe headache,Headache is excruciating,Headache is crushing,Sharp pain that go through her head,Today was a very bad day (regarding her headache)). The patient was treated with PARACETAMOL (TYLENOL) for Adverse event, at an unspecified dose and frequency and ASPIRIN [ACETYLSALICYLIC ACID] for Adverse event, at an unspecified dose and frequency. At the time of the report, HEADACHE (Severe headache,Headache is excruciating,Headache is crushing,Sharp pain that go through her head,Today was a very bad day (regarding her headache)) had not resolved and FEELING ABNORMAL (Started to feel very heal), INFLUENZA (Felt like she had the flu), FEELING COLD (Freezing to the point that she had to put on 6 layers of clothing and thermal wear) and PYREXIA (she was running fever) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, Blood test: normal (normal) Normal. On an unknown date, Computerised tomogram: normal (normal) Normal.     For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   No relevant concomitant medications were reported. Patient thought the side effect is neurological.; Sender's Comments: Based on the current available information and temporal association between the use of the product and the onset date of the events, a causal relationship cannot be excluded. Therefore, causality is assessed as possibly related.
Age: 52.0
Sex: M
Vaccine: COVID19
Symptoms: Pyrexia
Clinical narrative: He ran a little bit of a fever after 2nd shot; This spontaneous case was reported by a consumer and describes the occurrence of PYREXIA (He ran a little bit of a fever after 2nd shot) in a 52-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 006B21A, 012A21A and 053E21A) for COVID-19 vaccination.     The patient's past medical history included Dialysis (his dialysis treatments at home via a fistula) since an unknown date. Concurrent medical conditions included End stage renal disease (End stage renal patient), Arteriovenous fistula site bleeding (for couple of weeks and he had to have surgery on the day of this report) and Pain (The pain was so bad he had difficulty even going to the surgery).   On 01-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 29-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 25-Aug-2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 29-Mar-2021, the patient experienced PYREXIA (He ran a little bit of a fever after 2nd shot). At the time of the report, PYREXIA (He ran a little bit of a fever after 2nd shot) outcome was unknown.            No concomitant product was provided by the reporter. No treatment medication 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 event, a causal relationship cannot be excluded   This case was linked to MOD-2021-304984 (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 event, a causal relationship cannot be excluded
Sex: F
Vaccine: COVID19
Symptoms: Exposure during pregnancy
Clinical narrative: received the Moderna COVID-19 Vaccine while pregnant or planning to do so; This spontaneous prospective pregnancy case was reported by a consumer and describes the occurrence of EXPOSURE DURING PREGNANCY (received the Moderna COVID-19 Vaccine while pregnant or planning to do so) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On an unknown date, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. Last menstrual period and estimated date of delivery were not provided. On an unknown date, the patient experienced EXPOSURE DURING PREGNANCY (received the Moderna COVID-19 Vaccine while pregnant or planning to do so). At the time of the report, EXPOSURE DURING PREGNANCY (received the Moderna COVID-19 Vaccine while pregnant or planning to do so) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No concomitant medications provided. No treatment medications provided.; Sender's Comments: This is a case of maternal exposure during pregnancy with no associated AEs.
Age: 41.0
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, Drug ineffective
Clinical narrative: diagnosed with COVID-19; Lack of drug effect; This spontaneous case was reported by a consumer and describes the occurrence of COVID-19 (diagnosed with COVID-19) and DRUG INEFFECTIVE (Lack of drug effect) in a 42-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 021B21A and 027A21A) for COVID-19 vaccination.     No Medical History information was reported.   On 05-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 02-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 25-Aug-2021, the patient experienced COVID-19 (diagnosed with COVID-19). 25-Aug-2021, the patient experienced DRUG INEFFECTIVE (Lack of drug effect). At the time of the report, COVID-19 (diagnosed with COVID-19) and DRUG INEFFECTIVE (Lack of drug effect) outcome was unknown.            Concomitant product included thyroid medications. Treatment information was not provided.; Sender's Comments: Based on the mechanism of action of mRNA-1273 causal association between the event of COVID-19 infection and mRNA-1273 is assessed as not applicable. Causal association between the drug ineffective and mRNA-1273 is assessed as possible.
Sex: U
Vaccine: COVID19
Symptoms: COVID-19
Clinical narrative: Neighbors got COVID-19 last month after being vaccinated; 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 COVID-19 (Neighbors got COVID-19 last month after being vaccinated) and DRUG INEFFECTIVE (Drug ineffective) 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.    In March 2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. In August 2021, the patient experienced COVID-19 (Neighbors got COVID-19 last month after being vaccinated) and DRUG INEFFECTIVE (Drug ineffective). At the time of the report, COVID-19 (Neighbors got COVID-19 last month after being vaccinated) and DRUG INEFFECTIVE (Drug ineffective) outcome was unknown.            No Concomitant medication was reported. No treatment medications were reported  Reporter said they (her neighbors) believe they contracted it from their 4year old grandson who also tested positive for COVID-19. She did not have additional information at the time of the call.
Age: 36.0
Sex: F
Vaccine: COVID19
Symptoms: Anaphylactic reaction, Heart rate
Clinical narrative: anaphylactic reaction/"full anaphylactic reaction"; This spontaneous case was reported by a consumer and describes the occurrence of ANAPHYLACTIC REACTION (anaphylactic reaction/"full anaphylactic reaction") in a 36-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 025A21A) for COVID-19 vaccination.     The patient's past medical history included COVID-19 (almost killed her) in March 2021, Fertility decreased female and Surgery in February 2021. Concurrent medical conditions included Food allergy (Severe food allergies). Concomitant products included LITHIUM ACETATE, CETIRIZINE HYDROCHLORIDE (ZYRTEC [CETIRIZINE HYDROCHLORIDE]), MESTEROLONE (RESTORE [MESTEROLONE]), DESVENLAFAXINE SUCCINATE MONOHYDRATE (PRISTIQ), TROMETAMOL (TROMETHAMINE), AMLODIPINE BESILATE, ENALAPRIL MALEATE (SINERGEN), PARACETAMOL (TYLENOL) and TIZANIDINE HYDROCHLORIDE (ZANAFLEX) for an unknown indication.    On 30-Mar-2021, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 30-Mar-2021, the patient experienced ANAPHYLACTIC REACTION (anaphylactic reaction/"full anaphylactic reaction") (seriousness criteria hospitalization and medically significant). The patient was treated with METHYLPREDNISOLONE SODIUM SUCCINATE (SOLUMEDROL) for Breathing difficult, at an unspecified dose and frequency; DIPHENHYDRAMINE HYDROCHLORIDE (BENADRYL [DIPHENHYDRAMINE HYDROCHLORIDE]) for Adverse event, at an unspecified dose and frequency; METHYLPREDNISOLONE for Adverse event, at an unspecified dose and frequency and EPINEPHRINE (EPIPEN) for Adverse event, at an unspecified dose and frequency. At the time of the report, ANAPHYLACTIC REACTION (anaphylactic reaction/"full anaphylactic reaction") outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 30-Mar-2021, Heart rate: increased (High) increased.     mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was withdrawn on an unknown date.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   Company comment: Based on the current available information which shows a temporal association between the use of mRNA-1273 and the onset of the other events, a causal relationship cannot be excluded.  Anaphylactic reaction is consistent with the product known safety profile.  The event of product dose omission is assessed as not applicable   Most recent FOLLOW-UP information incorporated above includes: On 02-Sep-2021: Significant follow-up appended: New events added, seriousness updated and treatment medications were included.; Sender's Comments: Based on the current available information which shows a temporal association between the use of mRNA-1273 and the onset of the other events, a causal relationship cannot be excluded.  Anaphylactic reaction is consistent with the product known safety profile.  The event of product dose omission is assessed as not applicable
Age: 27.0
Sex: F
Vaccine: COVID19
Symptoms: Maternal exposure during pregnancy
Clinical narrative: received 1st dose while pregnant; This spontaneous prospective pregnancy case was reported by a consumer and describes the occurrence of MATERNAL EXPOSURE DURING PREGNANCY (received 1st dose while pregnant) in a 27-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 049E21A) for COVID-19 vaccination.     No Medical History information was reported.    On 01-Sep-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. Last menstrual period and estimated date of delivery were not provided. On 01-Sep-2021, the patient experienced MATERNAL EXPOSURE DURING PREGNANCY (received 1st dose while pregnant). On 01-Sep-2021, MATERNAL EXPOSURE DURING PREGNANCY (received 1st dose while pregnant) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No relevant concomitant medications were reported. Treatment medication was not provided by the reporter.; Sender's Comments: This is a case of maternal exposure during pregnancy of a 27 year old Female with no associated AEs. Patient will continue to be contacted for further monitoring.
Age: 76.0
Sex: F
Vaccine: COVID19
Symptoms: Vaccination site pain
Clinical narrative: My arm hurt at the injection site; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE PAIN (My arm hurt at the injection site) in a 76-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 025L20A) for COVID-19 vaccination.     No Medical History information was reported.    On 04-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 04-Jan-2021, the patient experienced VACCINATION SITE PAIN (My arm hurt at the injection site) (seriousness criterion hospitalization). At the time of the report, VACCINATION SITE PAIN (My arm hurt at the injection site) outcome was unknown.        mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) dosing remained unchanged.       No concomitant medications were provided. Treatment information not provided.  Second dose was taken on 1-Feb-2021 and patient was diagnosed with breast cancer on 15-Mar-2021, undergone lumpectomy on 7-Apr-2021. Patient also had had radiation treatment the 1st 3 weeks in May 2021. Booster dose was taken on 1-Sep-2021.  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 MOD-2021-305899, MOD-2021-305900 (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 event, a causal relationship cannot be excluded.
Age: 85.0
Sex: M
Vaccine: COVID19
Symptoms: Deafness, Deafness unilateral
Clinical narrative: Lost hearing in his right ear; lost hearing in both ears; This spontaneous case was reported by a consumer and describes the occurrence of DEAFNESS UNILATERAL (Lost hearing in his right ear) and DEAFNESS (lost hearing in both ears) in an 85-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 040c214 and 038C21A) for COVID-19 vaccination.     Concurrent medical conditions included COPD since 2007, Hypothyroidism, High cholesterol, Hypertension, Angina pectoris (Angina), Parkinson's disease, Asthma, Pre-diabetic, Overactive bladder (OAB) and Enlarged prostate. Concomitant products included LEVOTHYROXINE, ATORVASTATIN, SALBUTAMOL (ALBUTEROL HFA), LISINOPRIL, AMLODIPINE BESYLATE, PRAMIPEXOLE, HYDROCHLOROTHIAZIDE, TAMSULOSIN HCL, INFLUENZA VACCINE INACT SPLIT 4V (FLUZONE HIGH DOSE QUADRIVALENT), FLUTICASONE FUROATE, UMECLIDINIUM BROMIDE, VILANTEROL TRIFENATATE (TRELEGY ELLIPTA), FINASTERIDE, MIRABEGRON (MYRBETRIQ), BECLOMETASONE DIPROPIONATE (QVAR REDIHALER) and PNEUMOCOCCAL VACCINE CONJ 13V (CRM197) (PREVNAR 13) for an unknown indication.   On 23-Jun-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 28-Jul-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. In 2021, the patient experienced DEAFNESS (lost hearing in both ears) (seriousness criterion medically significant). On 27-Jun-2021, the patient experienced DEAFNESS UNILATERAL (Lost hearing in his right ear) (seriousness criterion medically significant). At the time of the report, DEAFNESS UNILATERAL (Lost hearing in his right ear) and DEAFNESS (lost hearing in both ears) had not resolved.            Treatment medication were not reported.  Partial hearing in his left ear.  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. Additional information has been requested.   This case was linked to MOD-2021-241895 (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.   Additional information has been requested.
Age: 76.0
Sex: F
Vaccine: COVID19
Symptoms: Arthralgia, Breast cancer, Chills, Headache, Pyrexia
Clinical narrative: Diagnosed with left breast cancer; Chills; Headache; Joint pain; Fever; This spontaneous case was reported by a consumer and describes the occurrence of BREAST CANCER (Diagnosed with left breast cancer) in a 76-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 032L20A and 025L20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.   On 04-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 01-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 01-Feb-2021, the patient experienced CHILLS (Chills), HEADACHE (Headache), ARTHRALGIA (Joint pain) and PYREXIA (Fever). On 15-Mar-2021, the patient experienced BREAST CANCER (Diagnosed with left breast cancer) (seriousness criteria hospitalization and medically significant). The patient was treated with Surgery (Lumpectomy) for Breast cancer. At the time of the report, BREAST CANCER (Diagnosed with left breast cancer), CHILLS (Chills), HEADACHE (Headache), ARTHRALGIA (Joint pain) and PYREXIA (Fever) outcome was unknown.      No concomitant medication was provided.  04Jan2021: The patient got the 1st dose of the Moderna Covid-19 vaccine. Her arm hurt at the injection site.  01Feb2021: The patient got the 2nd dose of the Moderna Covid-19 vaccine. The patient had chills, headache, joint pain, & fever.  15Mar2021: The patient was diagnosed with left breast Cancer.  07Apr2021: Lumpectomy  The patient had radiation treatment the 1st 3 weeks in May 2021.  Company Comment: Based on the current available information and temporal association between the use of the product and the start date of the event of breast cancer, an association appears unlikely, however with regard to the remaining events, a causal relationship cannot be excluded   This case was linked to MOD-2021-305824, MOD-2021-305900 (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 event of breast cancer, an association appears unlikely, however with regard to the remaining events, a causal relationship cannot be excluded
Age: 51.0
Sex: F
Vaccine: COVID19
Symptoms: Generalised tonic-clonic seizure, Headache
Clinical narrative: a bad headache for 3 days; grand mal seizure; Grand mal seizure; This spontaneous case was reported by a consumer and describes the occurrence of GENERALISED TONIC-CLONIC SEIZURE (Grand mal seizure) and GENERALISED TONIC-CLONIC SEIZURE (grand mal seizure) in a 51-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 939902) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     Concurrent medical conditions included Seizure. Concomitant products included LACOSAMIDE (VIMPAT) and LEVETIRACETAM (KEPPRA [LEVETIRACETAM]) for an unknown indication.    On 12-Aug-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 19-Aug-2021, the patient experienced GENERALISED TONIC-CLONIC SEIZURE (Grand mal seizure) (seriousness criterion medically significant). On 01-Sep-2021, the patient experienced GENERALISED TONIC-CLONIC SEIZURE (grand mal seizure) (seriousness criterion medically significant). On an unknown date, the patient experienced HEADACHE (a bad headache for 3 days). On 19-Aug-2021, GENERALISED TONIC-CLONIC SEIZURE (Grand mal seizure) had resolved. On 01-Sep-2021, GENERALISED TONIC-CLONIC SEIZURE (grand mal seizure) had resolved. At the time of the report, HEADACHE (a bad headache for 3 days) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       Treatment included use of magnet to swipe across their chest when a seizure occurs.  It was reported that patient had a DNS on the left side of their chest. Lab data included Blood tests.  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, underlying medical history of seizures and use of concomitant medication are cofounder.; 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, underlying medical history of seizures and use of concomitant medication are cofounder.
Sex: U
Vaccine: COVID19
Symptoms: Vaccination site reaction
Clinical narrative: Got the Moderna vaccine back in January 2021 I have had the covid arm ever since that 2nd vaccine shot about 8 months now; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE REACTION (Got the Moderna vaccine back in January 2021 I have had the covid arm ever since that 2nd vaccine shot about 8 months now) 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.    In January 2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. In January 2021, the patient experienced VACCINATION SITE REACTION (Got the Moderna vaccine back in January 2021 I have had the covid arm ever since that 2nd vaccine shot about 8 months now). At the time of the report, VACCINATION SITE REACTION (Got the Moderna vaccine back in January 2021 I have had the covid arm ever since that 2nd vaccine shot about 8 months now) had not resolved.            No concomitant drug details were reported.  No treatment details were reported.
Sex: U
Vaccine: COVID19
Symptoms: Expired product administered
Clinical narrative: Doses were administered after 24 hs of the first puncture of the vial; This spontaneous case was reported by a pharmacist and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Doses were administered after 24 hs of the first puncture of the vial) in a  patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 050C21A) 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 EXPIRED PRODUCT ADMINISTERED (Doses were administered after 24 hs of the first puncture of the vial). At the time of the report, EXPIRED PRODUCT ADMINISTERED (Doses were administered after 24 hs of the first puncture of the vial) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.
Age: 44.0
Sex: M
Vaccine: COVID19
Symptoms: COVID-19, Off label use, Oxygen saturation, Pneumonia
Clinical narrative: pneumonia; COVID-19; Off label dosing frequency; This spontaneous case was reported by a consumer and describes the occurrence of PNEUMONIA (pneumonia) and COVID-19 (COVID-19) in a 44-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 025B21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     Concomitant products included IBUPROFEN for Headache.    On 26-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. In April 2021, the patient experienced PNEUMONIA (pneumonia) (seriousness criteria hospitalization and medically significant) and COVID-19 (COVID-19) (seriousness criterion hospitalization). On an unknown date, the patient experienced OFF LABEL USE (Off label dosing frequency). At the time of the report, PNEUMONIA (pneumonia) and COVID-19 (COVID-19) outcome was unknown and OFF LABEL USE (Off label dosing frequency) had resolved.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): In April 2021, Oxygen saturation: decreased (Low) decreased.     The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Treatment for the events included Covid antibodies.  Company comment: This is a case of Off label use with associated AEs. Based on the current available information, the mRNA-1273 does not contain a virus capable of causing infection and with the occurrence of COVID-19 infection after vaccination, the causality of COVID 19 is assessed as not applicable. Based on the current available information and temporal association between the use of the product and other reported events, a causal relationship cannot be excluded. Event pneumonia was automatically upgraded as a serious event as list. Events Pneumonia and COVID-19  were upgraded to hospitalization seriousness criteria as per narrative in SD and per medical judgement, despite the were reported as non-serious.; Sender's Comments: This is a case of Off label use with associated AEs. Based on the current available information, the mRNA-1273 does not contain a virus capable of causing infection and with the occurrence of COVID-19 infection after vaccination, the causality of COVID 19 is assessed as not applicable. Based on the current available information and temporal association between the use of the product and other reported events, a causal relationship cannot be excluded. Event pneumonia was automatically upgraded as a serious event as per list. Events Pneumonia and COVID-19  were upgraded to hospitalization seriousness criteria as per narrative and per medical judgement, despite the were reported as non-serious.
Sex: U
Vaccine: COVID19
Symptoms: Expired product administered
Clinical narrative: Doses were administered after 24 hs of the first puncture of the vial; This spontaneous case was reported by a pharmacist and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Doses were administered after 24 hs of the first puncture of the vial) in a  patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 050C21A) 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 EXPIRED PRODUCT ADMINISTERED (Doses were administered after 24 hs of the first puncture of the vial). At the time of the report, EXPIRED PRODUCT ADMINISTERED (Doses were administered after 24 hs of the first puncture of the vial) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant medication details was reported. No treatment medication details was reported. Doses were administered after 24 hs of the first puncture of the vial. Doses were administered between 24 and 30 hs total after first puncture of the vial.
Sex: U
Vaccine: COVID19
Symptoms: Expired product administered
Clinical narrative: Doses were administered after 24 hs of the first puncture of the vial; This spontaneous case was reported by a pharmacist and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Doses were administered after 24 hs of the first puncture of the vial) in a patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 050C21A) 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 EXPIRED PRODUCT ADMINISTERED (Doses were administered after 24 hs of the first puncture of the vial). At the time of the report, EXPIRED PRODUCT ADMINISTERED (Doses were administered after 24 hs of the first puncture of the vial) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   Relevant concomitant medications were not provided. Treatment information was not provided