chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Sex: U
Vaccine: COVID19
Symptoms: Product dose omission issue
Clinical narrative: the 1st shot in march should i just start over; This spontaneous case was reported by a consumer and describes the occurrence of PRODUCT DOSE OMISSION ISSUE (the 1st shot in march should i just start over) 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 dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced PRODUCT DOSE OMISSION ISSUE (the 1st shot in march should i just start over). At the time of the report, PRODUCT DOSE OMISSION ISSUE (the 1st shot in march should i just start over) had resolved.      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.   No Concomitant medications were reported. No Treatment information was reported.
Sex: U
Vaccine: COVID19
Symptoms: Arthralgia, Hypoaesthesia
Clinical narrative: shoulder pain with numbness down into my fingers; shoulder pain with numbness down into my fingers; This spontaneous case was reported by a consumer and describes the occurrence of HYPOAESTHESIA (shoulder pain with numbness down into my fingers) and ARTHRALGIA (shoulder pain with numbness down into my fingers) 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 01-Aug-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 01-Aug-2021, the patient experienced HYPOAESTHESIA (shoulder pain with numbness down into my fingers) and ARTHRALGIA (shoulder pain with numbness down into my fingers). At the time of the report, HYPOAESTHESIA (shoulder pain with numbness down into my fingers) and ARTHRALGIA (shoulder pain with numbness down into my fingers) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No concomitant medication were reported. No treatment information was reported.   Reporter did not allow further contact
Sex: F
Vaccine: COVID19
Symptoms: Fatigue, Injection site pain
Clinical narrative: injection site soreness; exhaustion; This spontaneous case was reported by a consumer and describes the occurrence of INJECTION SITE PAIN (injection site soreness) and FATIGUE (exhaustion) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 939902) for COVID-19 vaccination.     No medical history and laboratory data was provided by the reporter.     On 09-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 INJECTION SITE PAIN (injection site soreness) and FATIGUE (exhaustion). At the time of the report, INJECTION SITE PAIN (injection site soreness) and FATIGUE (exhaustion) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No concomitant medications were reported.  No treatment medications were reported.  Patient stated to contact only through phone only.
Age: 91.0
Sex: F
Vaccine: COVID19
Symptoms: Limb discomfort
Clinical narrative: Left arm pain; This spontaneous case was reported by a consumer and describes the occurrence of LIMB DISCOMFORT (Left arm pain) in a 91-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 029K20a and 029L20A) for COVID-19 vaccination.     No Medical History information was reported.   On 20-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 16-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient experienced LIMB DISCOMFORT (Left arm pain). At the time of the report, LIMB DISCOMFORT (Left arm pain) outcome was unknown.            No concomitant medications were reported.  No treatment medication was reported.
Age: 72.0
Sex: F
Vaccine: COVID19
Symptoms: Dehydration, Feeling abnormal, Hypertension, Mobility decreased, Vision blurred
Clinical narrative: Felt like a bus hit; Couldn't move; Extreme high blood pressure; Blur vision; Dehydrated; This spontaneous case was reported by a consumer and describes the occurrence of FEELING ABNORMAL (Felt like a bus hit), MOBILITY DECREASED (Couldn't move), HYPERTENSION (Extreme high blood pressure), VISION BLURRED (Blur vision) and DEHYDRATION (Dehydrated) in a 72-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 013A21A and 004M20A) for COVID-19 vaccination.     No Medical History information was reported.  Concomitant products included PANTOPRAZOLE and ATORVASTATIN CALCIUM (LIPITOR) for an unknown indication.   On 27-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 24-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient experienced FEELING ABNORMAL (Felt like a bus hit), MOBILITY DECREASED (Couldn't move), HYPERTENSION (Extreme high blood pressure), VISION BLURRED (Blur vision) and DEHYDRATION (Dehydrated). At the time of the report, FEELING ABNORMAL (Felt like a bus hit), MOBILITY DECREASED (Couldn't move), HYPERTENSION (Extreme high blood pressure), VISION BLURRED (Blur vision) and DEHYDRATION (Dehydrated) outcome was unknown.            Treatment included IV Saline drip for dehydration
Age: 42.0
Sex: M
Vaccine: COVID19
Symptoms: Dyspnoea, Heart rate, Heart rate increased, Hypersensitivity, Pyrexia
Clinical narrative: Allergic reaction; Increased Heart Rate; Fever; Shortness of Breath; This spontaneous case was reported by a consumer (subsequently medically confirmed) and describes the occurrence of HEART RATE INCREASED (Increased Heart Rate), PYREXIA (Fever), DYSPNOEA (Shortness of Breath) and HYPERSENSITIVITY (Allergic reaction) in a 42-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 04021A) for COVID-19 vaccination.     No Medical History information was reported.    On 31-Jul-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 31-Jul-2021, the patient experienced HEART RATE INCREASED (Increased Heart Rate) (seriousness criterion hospitalization), PYREXIA (Fever) (seriousness criterion hospitalization) and DYSPNOEA (Shortness of Breath) (seriousness criterion hospitalization). On an unknown date, the patient experienced HYPERSENSITIVITY (Allergic reaction) (seriousness criterion hospitalization). The patient was treated with DIPHENHYDRAMINE HYDROCHLORIDE (BENADRYL A) for Adverse event, at an unspecified dose and frequency. On 31-Jul-2021, HEART RATE INCREASED (Increased Heart Rate) and DYSPNOEA (Shortness of Breath) had resolved. On 01-Aug-2021, PYREXIA (Fever) had resolved. At the time of the report, HYPERSENSITIVITY (Allergic reaction) outcome was unknown. DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 31-Jul-2021, Heart rate: increased (High) Increased.     The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Concomitant medications were not reported.  Company comment: Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded.; 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: 59.0
Sex: M
Vaccine: COVID19
Symptoms: Cough, Ear infection, Ear pain, Oropharyngeal pain
Clinical narrative: Cough; Pain in ears; Pain in throat; ear infection; This spontaneous case was reported by a consumer and describes the occurrence of COUGH (Cough), EAR PAIN (Pain in ears), OROPHARYNGEAL PAIN (Pain in throat) and EAR INFECTION (ear infection) in a 59-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 049C21A) for COVID-19 vaccination.     No Medical History information was reported.    On 26-Jun-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 06-Jul-2021, the patient experienced COUGH (Cough), EAR PAIN (Pain in ears), OROPHARYNGEAL PAIN (Pain in throat) and EAR INFECTION (ear infection). At the time of the report, COUGH (Cough), EAR PAIN (Pain in ears), OROPHARYNGEAL PAIN (Pain in throat) and EAR INFECTION (ear infection) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No concomitant medications were reported.   The patient was given antibiotic.   This case was linked to MOD-2021-284101 (Patient Link).; Sender's Comments: Very limited information regarding this event/s has been provided at this time. Further information has been requested
Age: 70.0
Sex: F
Vaccine: COVID19
Symptoms: Dermatitis contact, Pruritus, Sleep disorder, Vaccination site erythema, Vaccination site pruritus
Clinical narrative: Red ring in her arm was like poison ivy; It would itch so bad it would wake her up in the middles of the night; A devil itch; Itching very badly; Had a red ring in her arm; This spontaneous case was reported by a consumer and describes the occurrence of DERMATITIS CONTACT (Red ring in her arm was like poison ivy), SLEEP DISORDER (It would itch so bad it would wake her up in the middles of the night), PRURITUS (A devil itch), VACCINATION SITE PRURITUS (Itching very badly) and VACCINATION SITE ERYTHEMA (Had a red ring in her arm) in a 70-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 091621A) for COVID-19 vaccination.     The patient's past medical history included Surgery (vein surgery) on 10-Aug-2021. Concurrent medical conditions included Diabetes, Hypertension and Infarction (Multiple infarct). Concomitant products included OLMESARTAN MEDOXOMIL (BENICAR), CARVEDILOL (COREG), METFORMIN, ROSUVASTATIN CALCIUM (CRESTOR), GLIMEPIRIDE and APIXABAN (ELIQUIS) for an unknown indication.    On 21-Jul-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced DERMATITIS CONTACT (Red ring in her arm was like poison ivy), SLEEP DISORDER (It would itch so bad it would wake her up in the middles of the night), PRURITUS (A devil itch), VACCINATION SITE PRURITUS (Itching very badly) and VACCINATION SITE ERYTHEMA (Had a red ring in her arm). The patient was treated with LORATADINE (CLARITINE) at an unspecified dose and frequency. At the time of the report, DERMATITIS CONTACT (Red ring in her arm was like poison ivy), SLEEP DISORDER (It would itch so bad it would wake her up in the middles of the night), PRURITUS (A devil itch), VACCINATION SITE PRURITUS (Itching very badly) and VACCINATION SITE ERYTHEMA (Had a red ring in her arm) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.
Age: 59.0
Sex: M
Vaccine: COVID19
Symptoms: Blood pressure measurement, Blood urine present, Chills, Cough, Headache
Clinical narrative: Rapid pulse; Blood in urine; Night sweat; Cough; Swollen lymph node; Chills; Fever; Headache; This spontaneous case was reported by a consumer (subsequently medically confirmed) and describes the occurrence of PALPITATIONS (Rapid pulse), BLOOD URINE PRESENT (Blood in urine), NIGHT SWEATS (Night sweat), COUGH (Cough), LYMPHADENOPATHY (Swollen lymph node), CHILLS (Chills), PYREXIA (Fever) and HEADACHE (Headache) in a 59-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 026D21A and 049C21A) for COVID-19 vaccination.     No Medical History information was reported.   On 26-Jun-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 24-Jul-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 25-Jul-2021, the patient experienced PALPITATIONS (Rapid pulse) (seriousness criterion medically significant), BLOOD URINE PRESENT (Blood in urine) (seriousness criterion medically significant), NIGHT SWEATS (Night sweat) (seriousness criterion medically significant), COUGH (Cough) (seriousness criterion medically significant), LYMPHADENOPATHY (Swollen lymph node) (seriousness criterion medically significant), CHILLS (Chills) (seriousness criterion medically significant), PYREXIA (Fever) (seriousness criterion medically significant) and HEADACHE (Headache) (seriousness criterion medically significant). The patient was treated with AZITHROMYCIN (ZITHROMYCIN) for Adverse event, at an unspecified dose and frequency; DOXYCYCLINE (DOXYCYCLIN [DOXYCYCLINE]) for Adverse event, at an unspecified dose and frequency and LEVOFLOXACIN (LEVAQUIN) for Adverse event, at an unspecified dose and frequency. At the time of the report, PALPITATIONS (Rapid pulse), BLOOD URINE PRESENT (Blood in urine), NIGHT SWEATS (Night sweat), COUGH (Cough), LYMPHADENOPATHY (Swollen lymph node), CHILLS (Chills), PYREXIA (Fever) and HEADACHE (Headache) had not resolved.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 25-Jul-2021, Blood pressure measurement: high blood pressure (High) High blood pressure.         The  concomitant medications on use were not provided.  Patient was on three different antibiotics for the adverse events, he was not getting rather getting worse. His doctor was checking for tuberculosis and lymphoma.  Company Comment: Based on the current available information and temporal association between the use of the product and the start date of events, a causal relationship cannot be excluded.   This case was linked to MOD-2021-284085 (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 events, a causal relationship cannot be excluded.
Age: 59.0
Sex: M
Vaccine: COVID19
Symptoms: Lymphadenopathy, Night sweats, Palpitations, Pyrexia
Clinical narrative: Rapid pulse; Blood in urine; Night sweat; Cough; Swollen lymph node; Chills; Fever; Headache; This spontaneous case was reported by a consumer (subsequently medically confirmed) and describes the occurrence of PALPITATIONS (Rapid pulse), BLOOD URINE PRESENT (Blood in urine), NIGHT SWEATS (Night sweat), COUGH (Cough), LYMPHADENOPATHY (Swollen lymph node), CHILLS (Chills), PYREXIA (Fever) and HEADACHE (Headache) in a 59-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 026D21A and 049C21A) for COVID-19 vaccination.     No Medical History information was reported.   On 26-Jun-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 24-Jul-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 25-Jul-2021, the patient experienced PALPITATIONS (Rapid pulse) (seriousness criterion medically significant), BLOOD URINE PRESENT (Blood in urine) (seriousness criterion medically significant), NIGHT SWEATS (Night sweat) (seriousness criterion medically significant), COUGH (Cough) (seriousness criterion medically significant), LYMPHADENOPATHY (Swollen lymph node) (seriousness criterion medically significant), CHILLS (Chills) (seriousness criterion medically significant), PYREXIA (Fever) (seriousness criterion medically significant) and HEADACHE (Headache) (seriousness criterion medically significant). The patient was treated with AZITHROMYCIN (ZITHROMYCIN) for Adverse event, at an unspecified dose and frequency; DOXYCYCLINE (DOXYCYCLIN [DOXYCYCLINE]) for Adverse event, at an unspecified dose and frequency and LEVOFLOXACIN (LEVAQUIN) for Adverse event, at an unspecified dose and frequency. At the time of the report, PALPITATIONS (Rapid pulse), BLOOD URINE PRESENT (Blood in urine), NIGHT SWEATS (Night sweat), COUGH (Cough), LYMPHADENOPATHY (Swollen lymph node), CHILLS (Chills), PYREXIA (Fever) and HEADACHE (Headache) had not resolved.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 25-Jul-2021, Blood pressure measurement: high blood pressure (High) High blood pressure.         The  concomitant medications on use were not provided.  Patient was on three different antibiotics for the adverse events, he was not getting rather getting worse. His doctor was checking for tuberculosis and lymphoma.  Company Comment: Based on the current available information and temporal association between the use of the product and the start date of events, a causal relationship cannot be excluded.   This case was linked to MOD-2021-284085 (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 events, a causal relationship cannot be excluded.
Age: 50.0
Sex: F
Vaccine: COVID19
Symptoms: Expired product administered, Product temperature excursion issue
Clinical narrative: administered 4 doses of an affected vial; received dose of Moderna vaccine after excursion; This spontaneous case was reported by a pharmacist and describes the occurrence of PRODUCT TEMPERATURE EXCURSION ISSUE (received dose of Moderna vaccine after excursion) and EXPIRED PRODUCT ADMINISTERED (administered 4 doses of an affected vial) in a 50-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 052E21A) for COVID-19 vaccination.     No medical history is reported by reporter.     On 09-Aug-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 09-Aug-2021, the patient experienced PRODUCT TEMPERATURE EXCURSION ISSUE (received dose of Moderna vaccine after excursion). On an unknown date, the patient experienced EXPIRED PRODUCT ADMINISTERED (administered 4 doses of an affected vial). At the time of the report, PRODUCT TEMPERATURE EXCURSION ISSUE (received dose of Moderna vaccine after excursion) and EXPIRED PRODUCT ADMINISTERED (administered 4 doses of an affected vial) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   No concomitant medications were provided by the reporter.  No treatment information was provided by the reporter.
Age: 31.0
Sex: M
Vaccine: COVID19
Symptoms: Expired product administered, Product temperature excursion issue
Clinical narrative: received dose of Moderna vaccine after excursion; reported that he administered 4 doses of an affected vial; This spontaneous case was reported by a pharmacist and describes the occurrence of PRODUCT TEMPERATURE EXCURSION ISSUE (received dose of Moderna vaccine after excursion) and EXPIRED PRODUCT ADMINISTERED (reported that he administered 4 doses of an affected vial) in a 31-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 09-Aug-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 09-Aug-2021, the patient experienced PRODUCT TEMPERATURE EXCURSION ISSUE (received dose of Moderna vaccine after excursion) and EXPIRED PRODUCT ADMINISTERED (reported that he administered 4 doses of an affected vial). On 09-Aug-2021, PRODUCT TEMPERATURE EXCURSION ISSUE (received dose of Moderna vaccine after excursion) and EXPIRED PRODUCT ADMINISTERED (reported that he administered 4 doses of an affected vial) had resolved.       The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   Concomitant and treatment drugs were not provided.  The vaccine was actually delivered by McKesson on Thursday, 05-Aug-2021 and kept in the cooler box. On the evening of 08-Aug-2021, the pharmacist realized the vaccines were still in the shipping packaging and contacted the pharmacist on duty. The pharmacist on duty opened the packaging and visually observed that the vials were in a liquid state. When she clicked the tag alert, it showed a red X. She did not note the condition of the Phase Change Gelpack material in the shipping container. The pharmacist on duty put a glycol thermometer in the empty cooler overnight which showed the temperature range was 32-37 F, however the vaccine had already been moved to the refrigerator. The pharmacist also checked the Moderna excursion tool, which said to quarantine the vials. Due to the fact that the vaccine was in liquid state upon opening the packaging, the pharmacist used the Moderna Excursion Tool and labeled the vaccine 30 Day Use by Date as 03Sep2021 based on the results. Referred to Walmart's home office and Moderna for guidance.
Sex: U
Vaccine: COVID19
Symptoms: Expired product administered
Clinical narrative: Patient was administered expired Moderna vaccine; Based on the current case data, this case has been classified as invalid. This spontaneous case was reported by a pharmacist and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Patient was administered expired Moderna vaccine) in a patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 049C21A) for COVID-19 vaccination.     No Medical History information was reported.    On 10-Aug-2021, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 10-Aug-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (Patient was administered expired Moderna vaccine). On 10-Aug-2021, EXPIRED PRODUCT ADMINISTERED (Patient was administered expired Moderna vaccine) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   No concomitant medications were provided by the reporter. No treatment medications were provided by the reporter. Pharmacist reported that she administered expired vaccine to three patients on 10-AUG-2021 and  later it was discarded. She mentioned that punctured vial was left out all the day on 09-AUG-2021 for about 12 hours at room temperature.
Age: 50.0
Sex: F
Vaccine: COVID19
Symptoms: Peripheral swelling, Vaccination site pain
Clinical narrative: under my arm, where I put on deodorant, is a little swollen.; injection site arm was sore; This spontaneous case was reported by a consumer and describes the occurrence of PERIPHERAL SWELLING (under my arm, where I put on deodorant, is a little swollen.) and VACCINATION SITE PAIN (injection site arm was sore) in a 50-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 088D21A) for an unknown indication.     No Medical History information was reported.    On 09-Aug-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 09-Aug-2021, the patient experienced VACCINATION SITE PAIN (injection site arm was sore). On 11-Aug-2021, the patient experienced PERIPHERAL SWELLING (under my arm, where I put on deodorant, is a little swollen.). The patient was treated with PARACETAMOL (TYLENOL) for Injection site pain, at a dose of 2. At the time of the report, PERIPHERAL SWELLING (under my arm, where I put on deodorant, is a little swollen.) and VACCINATION SITE PAIN (injection site arm was sore) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No concomitant medication was provided by the reporter.
Sex: U
Vaccine: COVID19
Symptoms: Inappropriate schedule of product administration, Joint swelling, Lip swelling
Clinical narrative: lips swelling; ankles swelling; still hasn't gotten his second shot 6 months after the first; This spontaneous case was reported by a patient and describes the occurrence of LIP SWELLING (lips swelling), JOINT SWELLING (ankles swelling) and INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (still hasn't gotten his second shot 6 months after the first) 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 by the reporter.  Concomitant products included LISINOPRIL and BIMATOPROST (LUMIGAN) for an unknown indication.    On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced LIP SWELLING (lips swelling), JOINT SWELLING (ankles swelling) and INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (still hasn't gotten his second shot 6 months after the first). At the time of the report, LIP SWELLING (lips swelling) and JOINT SWELLING (ankles swelling) outcome was unknown and INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (still hasn't gotten his second shot 6 months after the first) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No treatment medications were provided.
Age: 39.0
Sex: M
Vaccine: COVID19
Symptoms: Poor quality product administered, Product temperature excursion issue
Clinical narrative: pharmacist reported that 4 doses of an affected vial of the Moderna COVID-19 vaccine were administered; received dose of Moderna vaccine after excursion; This spontaneous case was reported by a pharmacist and describes the occurrence of PRODUCT TEMPERATURE EXCURSION ISSUE (received dose of Moderna vaccine after excursion) and POOR QUALITY PRODUCT ADMINISTERED (pharmacist reported that 4 doses of an affected vial of the Moderna COVID-19 vaccine were administered) in a 39-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 09-Aug-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 08-Aug-2021, the patient experienced PRODUCT TEMPERATURE EXCURSION ISSUE (received dose of Moderna vaccine after excursion). On 09-Aug-2021, the patient experienced POOR QUALITY PRODUCT ADMINISTERED (pharmacist reported that 4 doses of an affected vial of the Moderna COVID-19 vaccine were administered). On 09-Aug-2021, POOR QUALITY PRODUCT ADMINISTERED (pharmacist reported that 4 doses of an affected vial of the Moderna COVID-19 vaccine were administered) had resolved. At the time of the report, PRODUCT TEMPERATURE EXCURSION ISSUE (received dose of Moderna vaccine after excursion) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   No Concomitant medications were provided.  No treatment medications were provided.
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 medications were reported.  No Treatment medications were reported.
Age: 91.0
Sex: F
Vaccine: COVID19
Symptoms: Muscular weakness
Clinical narrative: Her left arm as very week needing help from other arm to use it in the morning.; This spontaneous case was reported by a consumer and describes the occurrence of MUSCULAR WEAKNESS (Her left arm as very week needing help from other arm to use it in the morning.) in a 91-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 029K20a and 029L20A) for COVID-19 vaccination.     No Medical History information was reported.   On 20-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 16-Feb-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 MUSCULAR WEAKNESS (Her left arm as very week needing help from other arm to use it in the morning.). At the time of the report, MUSCULAR WEAKNESS (Her left arm as very week needing help from other arm to use it in the morning.) outcome was unknown.            No concomitant medications were provided. No treatments were provided.
Age: 27.0
Sex: M
Vaccine: COVID19
Symptoms: Cough, Dyspnoea, Insomnia, Nausea, Oropharyngeal pain
Clinical narrative: 5-6 times coughing out bloody mucous; breathing as a bit painful, stabbing pain; urge to cough always; trouble sleeping; throat pain; difficulty of breathing; slight nausea; almost puking; This spontaneous case was reported by a consumer and describes the occurrence of SECRETION DISCHARGE (5-6 times coughing out bloody mucous), PAINFUL RESPIRATION (breathing as a bit painful, stabbing pain), COUGH (urge to cough always), INSOMNIA (trouble sleeping) and OROPHARYNGEAL PAIN (throat pain) in a 27-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 038CZ1A and 638C21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     Concurrent medical conditions included Penicillin allergy, Drug allergy, Drug allergy, Drug allergy, Drug allergy and Fruit allergy.   On 09-Jul-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 06-Aug-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 09-Aug-2021, the patient experienced SECRETION DISCHARGE (5-6 times coughing out bloody mucous), PAINFUL RESPIRATION (breathing as a bit painful, stabbing pain), COUGH (urge to cough always), INSOMNIA (trouble sleeping), OROPHARYNGEAL PAIN (throat pain), DYSPNOEA (difficulty of breathing), NAUSEA (slight nausea) and VOMITING (almost puking). At the time of the report, SECRETION DISCHARGE (5-6 times coughing out bloody mucous), PAINFUL RESPIRATION (breathing as a bit painful, stabbing pain), COUGH (urge to cough always), INSOMNIA (trouble sleeping), OROPHARYNGEAL PAIN (throat pain), DYSPNOEA (difficulty of breathing), NAUSEA (slight nausea) and VOMITING (almost puking) outcome was unknown.            No concomitant medications were provided  The patient was trying to get an appointment with his doctor but he is on the verge of retiring and the license has expired already. Patient did not take any medication with the symptoms, just increased water intake. The patient confirmed not taking any regular prescribed medications or any supplements.   This case was linked to MOD-2021-285176 (Patient Link).
Age: 27.0
Sex: M
Vaccine: COVID19
Symptoms: Painful respiration, Secretion discharge, Vomiting
Clinical narrative: 5-6 times coughing out bloody mucous; breathing as a bit painful, stabbing pain; urge to cough always; trouble sleeping; throat pain; difficulty of breathing; slight nausea; almost puking; This spontaneous case was reported by a consumer and describes the occurrence of SECRETION DISCHARGE (5-6 times coughing out bloody mucous), PAINFUL RESPIRATION (breathing as a bit painful, stabbing pain), COUGH (urge to cough always), INSOMNIA (trouble sleeping) and OROPHARYNGEAL PAIN (throat pain) in a 27-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 038CZ1A and 638C21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     Concurrent medical conditions included Penicillin allergy, Drug allergy, Drug allergy, Drug allergy, Drug allergy and Fruit allergy.   On 09-Jul-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 06-Aug-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 09-Aug-2021, the patient experienced SECRETION DISCHARGE (5-6 times coughing out bloody mucous), PAINFUL RESPIRATION (breathing as a bit painful, stabbing pain), COUGH (urge to cough always), INSOMNIA (trouble sleeping), OROPHARYNGEAL PAIN (throat pain), DYSPNOEA (difficulty of breathing), NAUSEA (slight nausea) and VOMITING (almost puking). At the time of the report, SECRETION DISCHARGE (5-6 times coughing out bloody mucous), PAINFUL RESPIRATION (breathing as a bit painful, stabbing pain), COUGH (urge to cough always), INSOMNIA (trouble sleeping), OROPHARYNGEAL PAIN (throat pain), DYSPNOEA (difficulty of breathing), NAUSEA (slight nausea) and VOMITING (almost puking) outcome was unknown.            No concomitant medications were provided  The patient was trying to get an appointment with his doctor but he is on the verge of retiring and the license has expired already. Patient did not take any medication with the symptoms, just increased water intake. The patient confirmed not taking any regular prescribed medications or any supplements.   This case was linked to MOD-2021-285176 (Patient Link).
Sex: U
Vaccine: COVID19
Symptoms: COVID-19, Drug ineffective, SARS-CoV-2 test
Clinical narrative: Positive Covid test; I am fully vaccinated, both dose of modern a, yet I got infected wit h covid-sars; This spontaneous case was reported by a consumer and describes the occurrence of COVID-19 (Positive Covid test) and DRUG INEFFECTIVE (I am fully vaccinated, both dose of modern a, yet I got infected wit h covid-sars) 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, received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient experienced COVID-19 (Positive Covid test) and DRUG INEFFECTIVE (I am fully vaccinated, both dose of modern a, yet I got infected wit h covid-sars). At the time of the report, COVID-19 (Positive Covid test) and DRUG INEFFECTIVE (I am fully vaccinated, both dose of modern a, yet I got infected wit h covid-sars) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, SARS-CoV-2 test: positive (Positive) Positive.     No Concomitant medications were reported.  No Treatment medications were reported.  Company Comment: Very limited information regarding the events has been provided at this time.  Further information has been requested.; Sender's Comments: Very limited information regarding the events has been provided at this time.  Further information has been requested.
Sex: U
Vaccine: COVID19
Symptoms: Eczema
Clinical narrative: Outbreak with eczema; This spontaneous case was reported by a consumer and describes the occurrence of ECZEMA (Outbreak with eczema) 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 ECZEMA (Outbreak with eczema). At the time of the report, ECZEMA (Outbreak with eczema) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No concomitant medications were provided.  No treatment medications were provided.
Sex: U
Vaccine: COVID19
Symptoms: Chills, Pain, Pyrexia
Clinical narrative: body aches; fever with chills; fever; This spontaneous case was reported by a consumer and describes the occurrence of PAIN (body aches), CHILLS (fever with chills) and 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 second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient experienced PAIN (body aches), CHILLS (fever with chills) and PYREXIA (fever). At the time of the report, PAIN (body aches), CHILLS (fever with chills) and PYREXIA (fever) outcome was unknown.            No concomitant information was reported.   No treatment information was reported.   Reporter did not allow further contact
Age: 86.0
Sex: M
Vaccine: COVID19
Symptoms: Erythema multiforme, Rash, Rash erythematous, Rash pruritic
Clinical narrative: Erythema multiforme; little itchy; very red rash; extreme rash around both ankles; This spontaneous case was reported by a consumer and describes the occurrence of ERYTHEMA MULTIFORME (Erythema multiforme) in an 86-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 006M90A and 007B21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.   On 21-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 31-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 10-Aug-2021, the patient experienced ERYTHEMA MULTIFORME (Erythema multiforme) (seriousness criterion medically significant), RASH PRURITIC (little itchy), RASH ERYTHEMATOUS (very red rash) and RASH (extreme rash around both ankles). At the time of the report, ERYTHEMA MULTIFORME (Erythema multiforme), RASH PRURITIC (little itchy), RASH ERYTHEMATOUS (very red rash) and RASH (extreme rash around both ankles) outcome was unknown.            Concomitant medications included blood thinner medicine. Treatment information not provided. "Patient had a very red and a little itchy, a few months after he completed his 2 doses of the Moderna Covid-19 vaccine. He got the second dose in March and the rash only started 2 days ago. Patient says he did not have symptoms right after the shots, however he never had this kind of rash before. Patient confirms he did not have fever. Patients says that he looked it up online and says the rash is called Erythema multiforme as the images looked exactly what his rashes are. Patient says he only used a rash ointment and he will see his doctor tomorrow."  Company Comment: Very limited information regarding this event has been provided at this time.; Sender's Comments: Very limited information regarding this event has been provided at this time.
Age: 62.0
Sex: M
Vaccine: COVID19
Symptoms: Product dose omission issue
Clinical narrative: hasn't received second shot (>42 days following first dose); This spontaneous case was reported by a consumer and describes the occurrence of PRODUCT DOSE OMISSION ISSUE (hasn't received second shot (>42 days following first dose)) in a 62-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 028A21A) for COVID-19 vaccination.     No Medical History information was reported.    On 29-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 PRODUCT DOSE OMISSION ISSUE (hasn't received second shot (>42 days following first dose)). At the time of the report, PRODUCT DOSE OMISSION ISSUE (hasn't received second shot (>42 days following first dose)) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No concomitant medication was provided.  Treatment medication was not provided.
Sex: U
Vaccine: COVID19
Symptoms: Feeling abnormal, Pain in extremity, Tremor
Clinical narrative: Pain in arm; Shakiness; Feeling out of sorts; 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 PAIN IN EXTREMITY (Pain in arm), TREMOR (Shakiness) and FEELING ABNORMAL (Feeling out of sorts) 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 PAIN IN EXTREMITY (Pain in arm), TREMOR (Shakiness) and FEELING ABNORMAL (Feeling out of sorts). At the time of the report, PAIN IN EXTREMITY (Pain in arm), TREMOR (Shakiness) and FEELING ABNORMAL (Feeling out of sorts) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       Concomitant product information was not provided. Treatment information was not provided.
Age: 36.0
Sex: F
Vaccine: COVID19
Symptoms: Maternal exposure during pregnancy
Clinical narrative: Vaccine exposure during pregnancy; This spontaneous prospective pregnancy case was reported by a nurse and describes the occurrence of MATERNAL EXPOSURE DURING PREGNANCY (Vaccine exposure during pregnancy) in a 36-year-old female 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 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 MATERNAL EXPOSURE DURING PREGNANCY (Vaccine exposure during pregnancy). At the time of the report, MATERNAL EXPOSURE DURING PREGNANCY (Vaccine exposure during pregnancy) had resolved. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant medication was provided No treatment information was provided; Sender's Comments: This is a case of product exposure during pregnancy 36-year-old female. Patient will continue to be contacted for further monitoring of AEs during the pregnancy.
Sex: M
Vaccine: COVID19
Symptoms: Blister, Tenderness, Urticaria
Clinical narrative: Popping up on feet, like blisters with no fluid; Tender and sore; Welts on hands and feet; This spontaneous case was reported by a consumer and describes the occurrence of URTICARIA (Welts on hands and feet), BLISTER (Popping up on feet, like blisters with no fluid) and TENDERNESS (Tender and sore) in a 27-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 091D21A) for COVID-19 vaccination.     No Medical History information was reported.    On 30-Jul-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 09-Aug-2021, the patient experienced URTICARIA (Welts on hands and feet). On an unknown date, the patient experienced BLISTER (Popping up on feet, like blisters with no fluid) and TENDERNESS (Tender and sore). At the time of the report, URTICARIA (Welts on hands and feet), BLISTER (Popping up on feet, like blisters with no fluid) and TENDERNESS (Tender and sore) had not resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Concomitant medications were not provided.  Treatment information was not reported.
Age: 47.0
Sex: F
Vaccine: COVID19
Symptoms: Pruritus, Rash, Urticaria, Vaccination site erythema
Clinical narrative: hives; it's itching; like a rash in the arm; red, 3 or 2 inches, large area of red spots, its around the area of the vaccine shot and goes down the direction of the shoulder; This spontaneous case was reported by a consumer and describes the occurrence of URTICARIA (hives), PRURITUS (it's itching), RASH (like a rash in the arm) and VACCINATION SITE ERYTHEMA (red, 3 or 2 inches, large area of red spots, its around the area of the vaccine shot and goes down the direction of the shoulder) in a 47-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 038C21A) for COVID-19 vaccination.     No Medical History information was reported.    On 28-Jul-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced URTICARIA (hives), PRURITUS (it's itching), RASH (like a rash in the arm) and VACCINATION SITE ERYTHEMA (red, 3 or 2 inches, large area of red spots, its around the area of the vaccine shot and goes down the direction of the shoulder). At the time of the report, URTICARIA (hives), PRURITUS (it's itching), RASH (like a rash in the arm) and VACCINATION SITE ERYTHEMA (red, 3 or 2 inches, large area of red spots, its around the area of the vaccine shot and goes down the direction of the shoulder) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No concomitant medication reported. No treatment information was provided.   Reporter did not allow further contact
Sex: U
Vaccine: COVID19
Symptoms: Product dose omission issue, Vaccination complication
Clinical narrative: This spontaneous case reported by a consumer, describes the occurrence of vaccination complication (severe reaction/side effects) and product dose omission issue (did not get second vaccination) in a patient, of an unknown age and gender, who received mRNA-1273 (Moderna COVID-19 vaccine) for COVID-19 immunization. No medical history reported. On an unknown date, patient received the first dose of mRNA-1273 (Moderna COVID-19 vaccine), unknown route; 1 dosage form. On an unknown date, patient experienced vaccination complication (severe reaction/side effects) and product dose omission issue (did not get second vaccination). At the time of the report, vaccination complication (severe reaction/side effects) and product dose omission issue (did not get second vaccination) outcome: unknown. The action taken with mRNA-1273 (Moderna COVID-19  vaccine), unknown route; 1 dosage form. Patient continued to have side effects six months later. No concomitant products or treatment information reported.
Sex: U
Vaccine: COVID19
Symptoms: Extra dose administered
Clinical narrative: Third dose of Moderna COVID-19 vaccine inadvertently; 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 EXTRA DOSE ADMINISTERED (Third dose of Moderna COVID-19 vaccine inadvertently) 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 EXTRA DOSE ADMINISTERED (Third dose of Moderna COVID-19 vaccine inadvertently). At the time of the report, EXTRA DOSE ADMINISTERED (Third dose of Moderna COVID-19 vaccine inadvertently) 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 and treatment medications were not provided.   Reporter did not allow further contact