chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 55.0
Sex: F
Vaccine: COVID19
Symptoms: Anxiety, Dizziness, Fatigue, Headache, Impaired work ability
Clinical narrative: I have runny nose sore throat on and off; I have runny nose sore throat on and off; I was only able to work four days and have not been able to work since then; This has totally raised my anxiety level; dizziness; I am generally feeling unwell; swelling and redness in her arm which is warm; she feels extremely fatigued and have headaches; swelling and redness in her arm which is warm; swelling and redness in her arm which is warm; extremely fatigued and have headaches; This spontaneous case was reported by a consumer and describes the occurrence of OROPHARYNGEAL PAIN (I have runny nose sore throat on and off), RHINORRHOEA (I have runny nose sore throat on and off), IMPAIRED WORK ABILITY (I was only able to work four days and have not been able to work since then), ANXIETY (This has totally raised my anxiety level) and DIZZINESS (dizziness) in a 55-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 016C21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     no specified medical history was reported.  Concomitant products included GABAPENTIN, CLONIDINE, ALPRAZOLAM (XANAX) and CETIRIZINE HYDROCHLORIDE (ZYRTEC ALLERGY) for an unknown indication.    On 07-Aug-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 OROPHARYNGEAL PAIN (I have runny nose sore throat on and off), RHINORRHOEA (I have runny nose sore throat on and off), IMPAIRED WORK ABILITY (I was only able to work four days and have not been able to work since then), ANXIETY (This has totally raised my anxiety level), DIZZINESS (dizziness), VACCINATION COMPLICATION (I am generally feeling unwell), VACCINATION SITE WARMTH (swelling and redness in her arm which is warm), FATIGUE (she feels extremely fatigued and have headaches), VACCINATION SITE SWELLING (swelling and redness in her arm which is warm), VACCINATION SITE ERYTHEMA (swelling and redness in her arm which is warm) and HEADACHE (extremely fatigued and have headaches). At the time of the report, OROPHARYNGEAL PAIN (I have runny nose sore throat on and off), RHINORRHOEA (I have runny nose sore throat on and off), IMPAIRED WORK ABILITY (I was only able to work four days and have not been able to work since then), ANXIETY (This has totally raised my anxiety level), DIZZINESS (dizziness), VACCINATION COMPLICATION (I am generally feeling unwell), VACCINATION SITE WARMTH (swelling and redness in her arm which is warm), FATIGUE (she feels extremely fatigued and have headaches), VACCINATION SITE SWELLING (swelling and redness in her arm which is warm), VACCINATION SITE ERYTHEMA (swelling and redness in her arm which is warm) and HEADACHE (extremely fatigued and have headaches) had not resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       Treatment information was not reported.
Age: 55.0
Sex: F
Vaccine: COVID19
Symptoms: Oropharyngeal pain, Rhinorrhoea, Vaccination complication, Vaccination site erythema, Vaccination site swelling
Clinical narrative: I have runny nose sore throat on and off; I have runny nose sore throat on and off; I was only able to work four days and have not been able to work since then; This has totally raised my anxiety level; dizziness; I am generally feeling unwell; swelling and redness in her arm which is warm; she feels extremely fatigued and have headaches; swelling and redness in her arm which is warm; swelling and redness in her arm which is warm; extremely fatigued and have headaches; This spontaneous case was reported by a consumer and describes the occurrence of OROPHARYNGEAL PAIN (I have runny nose sore throat on and off), RHINORRHOEA (I have runny nose sore throat on and off), IMPAIRED WORK ABILITY (I was only able to work four days and have not been able to work since then), ANXIETY (This has totally raised my anxiety level) and DIZZINESS (dizziness) in a 55-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 016C21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     no specified medical history was reported.  Concomitant products included GABAPENTIN, CLONIDINE, ALPRAZOLAM (XANAX) and CETIRIZINE HYDROCHLORIDE (ZYRTEC ALLERGY) for an unknown indication.    On 07-Aug-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 OROPHARYNGEAL PAIN (I have runny nose sore throat on and off), RHINORRHOEA (I have runny nose sore throat on and off), IMPAIRED WORK ABILITY (I was only able to work four days and have not been able to work since then), ANXIETY (This has totally raised my anxiety level), DIZZINESS (dizziness), VACCINATION COMPLICATION (I am generally feeling unwell), VACCINATION SITE WARMTH (swelling and redness in her arm which is warm), FATIGUE (she feels extremely fatigued and have headaches), VACCINATION SITE SWELLING (swelling and redness in her arm which is warm), VACCINATION SITE ERYTHEMA (swelling and redness in her arm which is warm) and HEADACHE (extremely fatigued and have headaches). At the time of the report, OROPHARYNGEAL PAIN (I have runny nose sore throat on and off), RHINORRHOEA (I have runny nose sore throat on and off), IMPAIRED WORK ABILITY (I was only able to work four days and have not been able to work since then), ANXIETY (This has totally raised my anxiety level), DIZZINESS (dizziness), VACCINATION COMPLICATION (I am generally feeling unwell), VACCINATION SITE WARMTH (swelling and redness in her arm which is warm), FATIGUE (she feels extremely fatigued and have headaches), VACCINATION SITE SWELLING (swelling and redness in her arm which is warm), VACCINATION SITE ERYTHEMA (swelling and redness in her arm which is warm) and HEADACHE (extremely fatigued and have headaches) had not resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       Treatment information was not reported.
Age: 55.0
Sex: F
Vaccine: COVID19
Symptoms: Vaccination site warmth
Clinical narrative: I have runny nose sore throat on and off; I have runny nose sore throat on and off; I was only able to work four days and have not been able to work since then; This has totally raised my anxiety level; dizziness; I am generally feeling unwell; swelling and redness in her arm which is warm; she feels extremely fatigued and have headaches; swelling and redness in her arm which is warm; swelling and redness in her arm which is warm; extremely fatigued and have headaches; This spontaneous case was reported by a consumer and describes the occurrence of OROPHARYNGEAL PAIN (I have runny nose sore throat on and off), RHINORRHOEA (I have runny nose sore throat on and off), IMPAIRED WORK ABILITY (I was only able to work four days and have not been able to work since then), ANXIETY (This has totally raised my anxiety level) and DIZZINESS (dizziness) in a 55-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 016C21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     no specified medical history was reported.  Concomitant products included GABAPENTIN, CLONIDINE, ALPRAZOLAM (XANAX) and CETIRIZINE HYDROCHLORIDE (ZYRTEC ALLERGY) for an unknown indication.    On 07-Aug-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 OROPHARYNGEAL PAIN (I have runny nose sore throat on and off), RHINORRHOEA (I have runny nose sore throat on and off), IMPAIRED WORK ABILITY (I was only able to work four days and have not been able to work since then), ANXIETY (This has totally raised my anxiety level), DIZZINESS (dizziness), VACCINATION COMPLICATION (I am generally feeling unwell), VACCINATION SITE WARMTH (swelling and redness in her arm which is warm), FATIGUE (she feels extremely fatigued and have headaches), VACCINATION SITE SWELLING (swelling and redness in her arm which is warm), VACCINATION SITE ERYTHEMA (swelling and redness in her arm which is warm) and HEADACHE (extremely fatigued and have headaches). At the time of the report, OROPHARYNGEAL PAIN (I have runny nose sore throat on and off), RHINORRHOEA (I have runny nose sore throat on and off), IMPAIRED WORK ABILITY (I was only able to work four days and have not been able to work since then), ANXIETY (This has totally raised my anxiety level), DIZZINESS (dizziness), VACCINATION COMPLICATION (I am generally feeling unwell), VACCINATION SITE WARMTH (swelling and redness in her arm which is warm), FATIGUE (she feels extremely fatigued and have headaches), VACCINATION SITE SWELLING (swelling and redness in her arm which is warm), VACCINATION SITE ERYTHEMA (swelling and redness in her arm which is warm) and HEADACHE (extremely fatigued and have headaches) had not resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       Treatment information was not reported.
Age: 80.0
Sex: F
Vaccine: COVID19
Symptoms: Pain in extremity, Product dose omission issue
Clinical narrative: Had a sore arm for a couple of days; Patient did not receive their second dose of the Moderna COVID-19 vaccine for more than 36 days.; This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (Had a sore arm for a couple of days) and PRODUCT DOSE OMISSION ISSUE (Patient did not receive their second dose of the Moderna COVID-19 vaccine for more than 36 days.) in an 80-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 011D21A) for COVID-19 vaccination.     No medical history provided.  Concomitant products included ATORVASTATIN, HYDROCHLOROTHIAZIDE, LOSARTAN POTASSIUM (LOSARTAN + HIDROCLOROTIAZIDA), ACETYLSALICYLIC ACID (ASPIRIN (E.C.)), MONTELUKAST, ACARBOSE, AMLODIPINE, FUROSEMIDE, GABAPENTIN and GLIMEPIRIDE for an unknown indication.    On 23-Jul-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced PAIN IN EXTREMITY (Had a sore arm for a couple of days) and PRODUCT DOSE OMISSION ISSUE (Patient did not receive their second dose of the Moderna COVID-19 vaccine for more than 36 days.). At the time of the report, PAIN IN EXTREMITY (Had a sore arm for a couple of days) and PRODUCT DOSE OMISSION ISSUE (Patient did not receive their second dose of the Moderna COVID-19 vaccine for more than 36 days.) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No treatment information was provided
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, SARS-CoV-2 test
Clinical narrative: Got covid 11 days after 1st dose/symptoms of covid-19 such as no taste and smell; This spontaneous case was reported by a consumer and describes the occurrence of COVID-19 (Got covid 11 days after 1st dose/symptoms of covid-19 such as no taste and smell) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced COVID-19 (Got covid 11 days after 1st dose/symptoms of covid-19 such as no taste and smell). At the time of the report, COVID-19 (Got covid 11 days after 1st dose/symptoms of covid-19 such as no taste and smell) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, SARS-CoV-2 test: positive (Positive) Positive.     The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No concomitant medications were reported by reporter Treatment information was not provided   This case was linked to MOD-2021-311265 (Patient Link).
Age: 75.0
Sex: F
Vaccine: COVID19
Symptoms: Acne, Vaccination site erythema, Vaccination site pain, Vaccination site swelling
Clinical narrative: Few hard small pimples in their face; Swelling at the injection site; Injection site hurt; Injection site got red; This spontaneous case was reported by a consumer and describes the occurrence of ACNE (Few hard small pimples in their face), VACCINATION SITE SWELLING (Swelling at the injection site), VACCINATION SITE PAIN (Injection site hurt) and VACCINATION SITE ERYTHEMA (Injection site got red) in a 75-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 007M20A) for COVID-19 vaccination.     No Medical History information was reported.    On 03-Feb-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced ACNE (Few hard small pimples in their face), VACCINATION SITE SWELLING (Swelling at the injection site), VACCINATION SITE PAIN (Injection site hurt) and VACCINATION SITE ERYTHEMA (Injection site got red). At the time of the report, ACNE (Few hard small pimples in their face), VACCINATION SITE SWELLING (Swelling at the injection site), VACCINATION SITE PAIN (Injection site hurt) and VACCINATION SITE ERYTHEMA (Injection site got red) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   The consumer stated that she received second dose of Moderna vaccine on 03Feb2021. She experienced swelling at the injection site, and it got red and hurt.   The consumer stated that around a month ago or maybe a little longer she noticed a few hard small pimples on the face.  No concomitant product use was provided by the reporter.   No treatment medications were reported.     This case was linked to MOD-2021-073303 (Patient Link).
Age: 67.0
Sex: F
Vaccine: COVID19
Symptoms: Expired product administered
Clinical narrative: Expired vaccine administered beyond 12 hours expiration for punctured vial; This spontaneous case was reported by a consumer and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Expired vaccine administered beyond 12 hours expiration for punctured vial) in a 67-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 058E21A) for COVID-19 vaccination.     No Medical History information was reported.    On 06-Sep-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 06-Sep-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (Expired vaccine administered beyond 12 hours expiration for punctured vial). At the time of the report, EXPIRED PRODUCT ADMINISTERED (Expired vaccine administered beyond 12 hours expiration for punctured vial) had resolved.        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.   Relevant concomitant medications were not provided. Treatment information was not provided.
Sex: U
Vaccine: COVID19
Symptoms: Asthenia
Clinical narrative: week; This spontaneous case was reported by a consumer and describes the occurrence of ASTHENIA (week) in a patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     The patient's past medical history included Heart disease aggravated. Concurrent medical conditions included Diabetic.    On an unknown date, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced ASTHENIA (week). At the time of the report, ASTHENIA (week) outcome was unknown. Not Provided          No concomitant medication was reported. No treatment history was reported.
Sex: U
Vaccine: COVID19
Symptoms: Body temperature, Heart rate, Hypoxia, Oxygen saturation, Pyrexia
Clinical narrative: Oxygen levels in the 80s for 6 hours of the first 10 after injection with the 3rd dose; Heart rate between 120-130; A fever of 102; This spontaneous case was reported by a consumer and describes the occurrence of HYPOXIA (Oxygen levels in the 80s for 6 hours of the first 10 after injection with the 3rd dose), TACHYCARDIA (Heart rate between 120-130) and PYREXIA (A fever of 102) 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 third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced HYPOXIA (Oxygen levels in the 80s for 6 hours of the first 10 after injection with the 3rd dose), TACHYCARDIA (Heart rate between 120-130) and PYREXIA (A fever of 102). At the time of the report, HYPOXIA (Oxygen levels in the 80s for 6 hours of the first 10 after injection with the 3rd dose), TACHYCARDIA (Heart rate between 120-130) and PYREXIA (A fever of 102) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, Body temperature: 102 (High) A fever of 102. On an unknown date, Heart rate: 120-130 (High) 120-130. On an unknown date, Oxygen saturation: low (Low) Oxygen levels in the 80s for 6 hours of the first 10 after injection with the 3rd dose.         No relevant concomitant medications were reported. No treatment information was reported.    This case was linked to MOD-2021-311180 (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.  Event of hypoxemia was automatically upgraded as a serious event as per IME list. However, based on information available and as per medical criteria was classified as Non-serious. No further information is expected since consent for follow up has been denied.
Sex: U
Vaccine: COVID19
Symptoms: Tachycardia
Clinical narrative: Oxygen levels in the 80s for 6 hours of the first 10 after injection with the 3rd dose; Heart rate between 120-130; A fever of 102; This spontaneous case was reported by a consumer and describes the occurrence of HYPOXIA (Oxygen levels in the 80s for 6 hours of the first 10 after injection with the 3rd dose), TACHYCARDIA (Heart rate between 120-130) and PYREXIA (A fever of 102) 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 third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced HYPOXIA (Oxygen levels in the 80s for 6 hours of the first 10 after injection with the 3rd dose), TACHYCARDIA (Heart rate between 120-130) and PYREXIA (A fever of 102). At the time of the report, HYPOXIA (Oxygen levels in the 80s for 6 hours of the first 10 after injection with the 3rd dose), TACHYCARDIA (Heart rate between 120-130) and PYREXIA (A fever of 102) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, Body temperature: 102 (High) A fever of 102. On an unknown date, Heart rate: 120-130 (High) 120-130. On an unknown date, Oxygen saturation: low (Low) Oxygen levels in the 80s for 6 hours of the first 10 after injection with the 3rd dose.         No relevant concomitant medications were reported. No treatment information was reported.    This case was linked to MOD-2021-311180 (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.  Event of hypoxemia was automatically upgraded as a serious event as per IME list. However, based on information available and as per medical criteria was classified as Non-serious. No further information is expected since consent for follow up has been denied.
Age: 65.0
Sex: F
Vaccine: COVID19
Symptoms: Expired product administered, Product storage error
Clinical narrative: Expired vaccine administered beyond 12 hours expiration for punctured vial; Vial was first punctured on 05-Sep-2021 at 11:00 AM and was kept in refrigerator/ was discarded on 06-Sep-2021 after 04:30 PM; This spontaneous case was reported by a pharmacist and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Expired vaccine administered beyond 12 hours expiration for punctured vial) and PRODUCT STORAGE ERROR (Vial was first punctured on 05-Sep-2021 at 11:00 AM and was kept in refrigerator/ was discarded on 06-Sep-2021 after 04:30 PM) in a 65-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 058E21A) for COVID-19 vaccination.     No Medical History information was reported.    On 06-Sep-2021 at 4:30 PM, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 05-Sep-2021 at 11:00 AM, the patient experienced PRODUCT STORAGE ERROR (Vial was first punctured on 05-Sep-2021 at 11:00 AM and was kept in refrigerator/ was discarded on 06-Sep-2021 after 04:30 PM). On 06-Sep-2021 at 4:30 PM, the patient experienced EXPIRED PRODUCT ADMINISTERED (Expired vaccine administered beyond 12 hours expiration for punctured vial). On 06-Sep-2021, PRODUCT STORAGE ERROR (Vial was first punctured on 05-Sep-2021 at 11:00 AM and was kept in refrigerator/ was discarded on 06-Sep-2021 after 04:30 PM) had resolved. On 06-Sep-2021 at 4:30 PM, EXPIRED PRODUCT ADMINISTERED (Expired vaccine administered beyond 12 hours expiration for punctured vial) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant medications were provided.  No Treatment information was provided.  The vial was initially stored in the refrigerator on 31-Aug-2021. The vaccine was administered at room temperature. The vial did not undergo any previous temperature excursions. The reporter stated that the total amount of time the vial was exposed to room temperature range 46° to 77° F was from 06-Sep-2021 9:00 AM.   This case was linked to MOD-2021-311383 (Patient Link).
Sex: M
Vaccine: COVID19
Symptoms: Chills, Pyrexia, Tremor, Vertigo
Clinical narrative: High fever; chills; shakes; vertigo a few times; This spontaneous case was reported by a consumer and describes the occurrence of PYREXIA (High fever), CHILLS (chills), TREMOR (shakes) and VERTIGO (vertigo a few times) in a male patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. Unknown) for COVID-19 vaccination.     No Medical History information was reported.    On an unknown date, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced PYREXIA (High fever), CHILLS (chills), TREMOR (shakes) and VERTIGO (vertigo a few times). At the time of the report, PYREXIA (High fever), CHILLS (chills), TREMOR (shakes) and VERTIGO (vertigo a few times) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       Concomitant medication not reported.  Treatment medication not reported.
Sex: F
Vaccine: COVID19
Symptoms: Corneal oedema, Nerve injury, Vaccination complication
Clinical narrative: I have corneal fluid; Also some nerve issues; Most of the reactions I had to the first one were the normal ones same with second one; This spontaneous case was reported by a consumer and describes the occurrence of CORNEAL OEDEMA (I have corneal fluid), NERVE INJURY (Also some nerve issues) and VACCINATION COMPLICATION (Most of the reactions I had to the first one were the normal ones same with second one) 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.    In February 2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. In February 2021, the patient experienced CORNEAL OEDEMA (I have corneal fluid) and NERVE INJURY (Also some nerve issues). In 2021, the patient experienced VACCINATION COMPLICATION (Most of the reactions I had to the first one were the normal ones same with second one). At the time of the report, CORNEAL OEDEMA (I have corneal fluid) and NERVE INJURY (Also some nerve issues) had not resolved and VACCINATION COMPLICATION (Most of the reactions I had to the first one were the normal ones same with second one) outcome was unknown.            No relevant concomitant medications were reported. No treatment information was provided.   This case was linked to MOD-2021-311222 (Patient Link).
Age: 50.0
Sex: M
Vaccine: COVID19
Symptoms: COVID-19, Drug ineffective
Clinical narrative: Contracted COVID-19 after both doses of the Moderna COVID-19 vaccine; Drug ineffective; This spontaneous case was reported by a consumer and describes the occurrence of COVID-19 (Contracted COVID-19 after both doses of the Moderna COVID-19 vaccine) and DRUG INEFFECTIVE (Drug ineffective) in a 50-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     Concurrent medical conditions included Asthma.   In March 2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. In April 2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 07-Aug-2021, the patient experienced COVID-19 (Contracted COVID-19 after both doses of the Moderna COVID-19 vaccine) and DRUG INEFFECTIVE (Drug ineffective). On 07-Sep-2021, COVID-19 (Contracted COVID-19 after both doses of the Moderna COVID-19 vaccine) had resolved. At the time of the report, DRUG INEFFECTIVE (Drug ineffective) outcome was unknown.            No relevant concomitant medications were reported. No treatment information was reported.   This case was linked to MOD-2021-311270 (Patient Link).; Sender's Comments: This case concerns an 50-year-old, male subject medical history of asthma, who experienced the non-serious unexpected events of COVID 19 and Drug ineffective. The event occurred approximately four months after the second dose of Spikevax. The event Drug ineffective was considered as related to the product per the reporter's assessment. Rechallenge was unknown since there's no information. The association between the event of COVID-19 and mRNA-1273 is assessed as not applicable.  The benefit risk relationship of spikevax is not affected by this report.
Sex: U
Vaccine: COVID19
Symptoms: Headache, Pyrexia, Sinus disorder, Vaccination complication
Clinical narrative: felt the effects; low grade fever for Tuesday and some of Wednesday; Sunday and still having sinus like symptoms; mild to moderate headaches; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION COMPLICATION (felt the effects), PYREXIA (low grade fever for Tuesday and some of Wednesday), SINUS DISORDER (Sunday and still having sinus like symptoms) and HEADACHE (mild to moderate headaches) in a patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. Unknown) for COVID-19 vaccination.     No Medical History information was reported.    On an unknown date, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced VACCINATION COMPLICATION (felt the effects), PYREXIA (low grade fever for Tuesday and some of Wednesday), SINUS DISORDER (Sunday and still having sinus like symptoms) and HEADACHE (mild to moderate headaches). At the time of the report, VACCINATION COMPLICATION (felt the effects), PYREXIA (low grade fever for Tuesday and some of Wednesday), SINUS DISORDER (Sunday and still having sinus like symptoms) and HEADACHE (mild to moderate headaches) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       Patient took booster shot last Monday afternoon and felt the effects including low grade fever for Tuesday band some of Wednesday. It is Sunday and still having sinus like symptoms along with mild to moderate headaches.  Concomitant medication use was not provided Treatment information was not provided,
Age: 40.0
Sex: M
Vaccine: COVID19
Symptoms: COVID-19, SARS-CoV-2 test
Clinical narrative: Came down with covid; This spontaneous case was reported by a consumer and describes the occurrence of COVID-19 (Came down with covid) in a 40-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 052E21A) for COVID-19 vaccination.     No Medical History information was reported.    On 18-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 COVID-19 (Came down with covid). At the time of the report, COVID-19 (Came down with covid) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, SARS-CoV-2 test: positive (Positive) Positive.     The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       The concomitant medication was not reported. The patient stated that got the regeneron antibody infusion treatment which was composed of 4 shots. The patient stated that was unsure of the waiting time after the antibody infusion whether it is 30 days or 90 days. and a nurse even told him that he may need to be restarted on the vaccination series.
Age: 54.0
Sex: F
Vaccine: COVID19
Symptoms: Expired product administered
Clinical narrative: vial was opened at 5:24 PM on 01Sep2021; This spontaneous case was reported by a pharmacist and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (vial was opened at 5:24 PM on 01Sep2021) in a 54-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 037F21A and 007D21A) for COVID-19 vaccination.     No Medical History information was reported.   On 04-Aug-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 02-Sep-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 02-Sep-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (vial was opened at 5:24 PM on 01Sep2021). On 02-Sep-2021, EXPIRED PRODUCT ADMINISTERED (vial was opened at 5:24 PM on 01Sep2021) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   The concomitant medication was not reported.   The treatment medication was not provided.   This case was linked to MOD-2021-311050, MOD-2021-311042 (Patient Link).   Most recent FOLLOW-UP information incorporated above includes: On 09-Sep-2021: Follow up appended contains no new information
Sex: U
Vaccine: COVID19
Symptoms: Nasal congestion, Oropharyngeal pain
Clinical narrative: Congestion; sore throat; This spontaneous case was reported by a consumer and describes the occurrence of NASAL CONGESTION (Congestion) and OROPHARYNGEAL PAIN (sore throat) 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 NASAL CONGESTION (Congestion) and OROPHARYNGEAL PAIN (sore throat). At the time of the report, NASAL CONGESTION (Congestion) and OROPHARYNGEAL PAIN (sore throat) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       Concomitant medications were not reported. Treatment medications were not reported.
Sex: M
Vaccine: COVID19
Symptoms: COVID-19, Drug ineffective, Illness
Clinical narrative: This spontaneous case was reported by a consumer and describes the occurrence of DRUG INEFFECTIVE (Father got Moderna, and he has coronavirus), ILLNESS (Had it for a couple days and he is very sick.) and COVID-19 (Covid positive) 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. In December 2020, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. In January 2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 05-Sep-2021, the patient experienced DRUG INEFFECTIVE (Father got Moderna, and he has coronavirus). On an unknown date, the patient experienced ILLNESS (Had it for a couple days and he is very sick.) and COVID-19 (Covid positive). At the time of the report, DRUG INEFFECTIVE (Father got Moderna, and he has coronavirus), ILLNESS (Had it for a couple days and he is very sick.) and COVID-19 (Covid positive) outcome was unknown.    DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, COVID-19: positive (Positive) positive. No relevant concomitant medications were reported. No treatment information was reported. Most recent FOLLOW-UP information incorporated above includes: On 08-Sep-2021: Follow-up received on 08-SEP-2021 contains significant information: Event Covid positive; Sender's Comments: This report refers to a case of Drug ineffective for mRNA-1273, lot # unknown with adverse events. Very limited information regarding this event has been provided at this time. Further information regarding temporal association is necessary. Further information has been requested. For the event COVID-19, 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.
Age: 71.0
Sex: M
Vaccine: COVID19
Symptoms: Pain in extremity
Clinical narrative: Sore arm; This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (Sore arm) in a 71-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 042L20A) for COVID-19 vaccination.     No Medical History information was reported.    On 26-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced PAIN IN EXTREMITY (Sore arm). At the time of the report, PAIN IN EXTREMITY (Sore arm) outcome was unknown.        mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosing remained unchanged.       No concomitant medications were provided. No treatment medications were reported.    This case was linked to MOD-2021-311212, MOD-2021-311337 (Patient Link).
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 Concomitant medication information was provided.   No Treatment medication s were provided.
Sex: U
Vaccine: COVID19
Symptoms: Hot flush, Vaccination complication
Clinical narrative: hot flashes day and night; experienced a side effect; This spontaneous case was reported by a consumer and describes the occurrence of HOT FLUSH (hot flashes day and night) and VACCINATION COMPLICATION (experienced a side effect) in a patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On 08-Mar-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 08-Mar-2021, the patient experienced HOT FLUSH (hot flashes day and night) and VACCINATION COMPLICATION (experienced a side effect). At the time of the report, HOT FLUSH (hot flashes day and night) and VACCINATION COMPLICATION (experienced a side effect) outcome was unknown.            No concomitant medications were reported  No treatment information was provided
Sex: U
Vaccine: COVID19
Symptoms: Chills, Headache, Nausea, Pyrexia
Clinical narrative: Fever; Chills; Headache; Nausea; 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 PYREXIA (Fever), CHILLS (Chills), HEADACHE (Headache) and NAUSEA (Nausea) in a  patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical history was provided.  Concomitant products included OCRELIZUMAB (OCREVUS) for an unknown indication.    On an unknown date, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced PYREXIA (Fever), CHILLS (Chills), HEADACHE (Headache) and NAUSEA (Nausea). At the time of the report, PYREXIA (Fever), CHILLS (Chills), HEADACHE (Headache) and NAUSEA (Nausea) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No Treatment medications were provided.
Sex: U
Vaccine: COVID19
Symptoms: Expired product administered, Product temperature excursion issue
Clinical narrative: Dose administered from vial over 12 hours after vial puncture.; temperature excursion; Based on the current case data, this case has been classified as invalid. This spontaneous case was reported by an other health care professional and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Dose administered from vial over 12 hours after vial puncture.) and PRODUCT TEMPERATURE EXCURSION ISSUE (temperature excursion) in a  patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced EXPIRED PRODUCT ADMINISTERED (Dose administered from vial over 12 hours after vial puncture.) and PRODUCT TEMPERATURE EXCURSION ISSUE (temperature excursion). At the time of the report, EXPIRED PRODUCT ADMINISTERED (Dose administered from vial over 12 hours after vial puncture.) had resolved and PRODUCT TEMPERATURE EXCURSION ISSUE (temperature excursion) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No  Concomitant medications were provided. No Treatment medications were provided.
Age: 49.0
Sex: M
Vaccine: COVID19
Symptoms: Balance disorder, Dizziness
Clinical narrative: he feels an effect of light headedness; Dizziness; feels like he is losing his balance; This spontaneous case was reported by a consumer and describes the occurrence of DIZZINESS (he feels an effect of light headedness), DIZZINESS (Dizziness) and BALANCE DISORDER (feels like he is losing his balance) in a 49-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 03321A and 023C21A) for COVID-19 vaccination.     No Medical History information was reported.   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 08-Jun-2021, the patient experienced DIZZINESS (he feels an effect of light headedness), DIZZINESS (Dizziness) and BALANCE DISORDER (feels like he is losing his balance). At the time of the report, DIZZINESS (he feels an effect of light headedness), DIZZINESS (Dizziness) and BALANCE DISORDER (feels like he is losing his balance) outcome was unknown.            Patient stated that he took his first dose of vaccine on 7MAY2021 with lot-023C21A through intramuscular but he reports that he did not have any adverse events. No concomitant medications were provided by reporter. No treatment medications were provided by reporter.
Age: 51.0
Sex: F
Vaccine: COVID19
Symptoms: Limb discomfort, Periarthritis
Clinical narrative: Frozen shoulder; is still having problem moving her arm behind her head; This spontaneous case was reported by a consumer and describes the occurrence of PERIARTHRITIS (Frozen shoulder) and LIMB DISCOMFORT (is still having problem moving her arm behind her head) in a 51-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 044A21A) for COVID-19 vaccination.     No Medical History information was reported.    On 17-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced PERIARTHRITIS (Frozen shoulder) and LIMB DISCOMFORT (is still having problem moving her arm behind her head). At the time of the report, PERIARTHRITIS (Frozen shoulder) was resolving and LIMB DISCOMFORT (is still having problem moving her arm behind her head) had not resolved.        mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosing remained unchanged.       No concomitant medications were provided by reporter. She has been taking vitamins to help with the numbness and she got steroid for the frozen shoulder. Some improvement with the neurological symptoms but with the shoulders, not so much.   This case was linked to MOD-2021-311486 (Patient Link).
Age: 62.0
Sex: F
Vaccine: COVID19
Symptoms: Balance disorder
Clinical narrative: had balance issues for 4 months after her 2nd sho/If she turned a certain way, you could tell; This spontaneous case was reported by a nurse and describes the occurrence of BALANCE DISORDER (had balance issues for 4 months after her 2nd sho/If she turned a certain way, you could tell) in a 62-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 026L20A) for COVID-19 vaccination.     No Medical History information was reported.   On 29-Dec-2020, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 26-Jan-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 BALANCE DISORDER (had balance issues for 4 months after her 2nd sho/If she turned a certain way, you could tell). At the time of the report, BALANCE DISORDER (had balance issues for 4 months after her 2nd sho/If she turned a certain way, you could tell) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   No Concomitant medication was reported No treatment Drug was reported
Age: 56.0
Sex: F
Vaccine: COVID19
Symptoms: Expired product administered
Clinical narrative: Expired vaccine administered beyond 12 hours expiration for punctured vial; This spontaneous case was reported by a health care professional and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Expired vaccine administered beyond 12 hours expiration for punctured vial) in a 56-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 058E21A) for COVID-19 vaccination.     No Medical History information was reported.    On 06-Sep-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 06-Sep-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (Expired vaccine administered beyond 12 hours expiration for punctured vial). On 06-Sep-2021, EXPIRED PRODUCT ADMINISTERED (Expired vaccine administered beyond 12 hours expiration for punctured 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.   Concomitant medication details were not reported by the reporter. Treatment details was not reported by the reporter. Other information related to product is vial was initially stored in the refrigerator on 31-AUG-2021. Product first punctured on 05-SEP-2021 11AM Kept in Refrigerator. Total amount of time the vial was exposed to room temperature range (46° to 77° F): "From 06SEP2021 9:00AM and discarded vial after 4:30PM.
Sex: U
Vaccine: COVID19
Symptoms: Headache, Myalgia, Nausea, Pyrexia, Sunburn
Clinical narrative: Feel like I have a sunburn; Running a fever; Ache all over; Headache; Very nauseass; This spontaneous case was reported by a consumer and describes the occurrence of SUNBURN (Feel like I have a sunburn), PYREXIA (Running a fever), MYALGIA (Ache all over), HEADACHE (Headache) and NAUSEA (Very nauseass) in a  patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced SUNBURN (Feel like I have a sunburn), PYREXIA (Running a fever), MYALGIA (Ache all over), HEADACHE (Headache) and NAUSEA (Very nauseass). The patient was treated with PARACETAMOL (TYLENOL) for Adverse event, at an unspecified dose and frequency. At the time of the report, SUNBURN (Feel like I have a sunburn), PYREXIA (Running a fever), MYALGIA (Ache all over), HEADACHE (Headache) and NAUSEA (Very nauseass) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       CONCOMITANT drugs were not provided.   Patient drank lot of water as treatment.   Reporter did not allow further contact
Sex: U
Vaccine: COVID19
Symptoms: Bradycardia, Heart rate, Palpitations
Clinical narrative: heart rate of 36; a lot of missed beats; This spontaneous case was reported by a consumer and describes the occurrence of BRADYCARDIA (heart rate of 36) and PALPITATIONS (a lot of missed beats) in a  patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On an unknown date, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced BRADYCARDIA (heart rate of 36) (seriousness criteria hospitalization and medically significant) and PALPITATIONS (a lot of missed beats) (seriousness criterion hospitalization). The patient was hospitalized for 3 days due to BRADYCARDIA and PALPITATIONS. At the time of the report, BRADYCARDIA (heart rate of 36) and PALPITATIONS (a lot of missed beats) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, Heart rate: 36 (Low) 36.         No concomitant was provided.  patient was in hospital for 3 days about 10 days after  2nd shot of moderna patient was with heart rate of 36 and had a lot of missed beats. Now on meds to help control it.  Company comment: Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded.; Sender's Comments: Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded.