chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 49.0
Sex: F
Vaccine: COVID19
Symptoms: Headache, Illness, Pain, Pain of skin, Pyrexia
Clinical narrative: Diarrhea since got the first shot; Skin was white; Everything hurt so bad.; Just touching my skin hurt.; The first one made me extremely sick; I thought I would die; Headache; Temperature was 99.7°F; Chills/was so cold that needed to enter the shower with hot water; Feeling cold; This spontaneous case was reported by a consumer and describes the occurrence of DIARRHOEA (Diarrhea since got the first shot), SKIN DISCOLOURATION (Skin was white), PAIN (Everything hurt so bad.), PAIN OF SKIN (Just touching my skin hurt.) and ILLNESS (The first one made me extremely sick) in a 49-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. D45C21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     The patient's past medical history included COVID-19 in December 2020.    On 30-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 DIARRHOEA (Diarrhea since got the first shot), SKIN DISCOLOURATION (Skin was white), PAIN (Everything hurt so bad.), PAIN OF SKIN (Just touching my skin hurt.), ILLNESS (The first one made me extremely sick), FEELING ABNORMAL (I thought I would die), HEADACHE (Headache), PYREXIA (Temperature was 99.7°F), CHILLS (Chills/was so cold that needed to enter the shower with hot water) and FEELING COLD (Feeling cold). The patient was treated with PARACETAMOL (TYLENOL [PARACETAMOL]) ongoing since an unknown date for Adverse event, at an unspecified dose and frequency. At the time of the report, DIARRHOEA (Diarrhea since got the first shot) and HEADACHE (Headache) had not resolved and SKIN DISCOLOURATION (Skin was white), PAIN (Everything hurt so bad.), PAIN OF SKIN (Just touching my skin hurt.), ILLNESS (The first one made me extremely sick), FEELING ABNORMAL (I thought I would die), PYREXIA (Temperature was 99.7°F), CHILLS (Chills/was so cold that needed to enter the shower with hot water) and FEELING COLD (Feeling cold) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, Body temperature: 99.7°f (High) High.     The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       About the concomitant medications The patient stated that she is taking some gastrointestinal stuff and something to help digest the food.Been taking medicines and homeopathic   This case was linked to MOD-2021-369270 (Patient Link).
Age: 49.0
Sex: F
Vaccine: COVID19
Symptoms: Skin discolouration
Clinical narrative: Diarrhea since got the first shot; Skin was white; Everything hurt so bad.; Just touching my skin hurt.; The first one made me extremely sick; I thought I would die; Headache; Temperature was 99.7°F; Chills/was so cold that needed to enter the shower with hot water; Feeling cold; This spontaneous case was reported by a consumer and describes the occurrence of DIARRHOEA (Diarrhea since got the first shot), SKIN DISCOLOURATION (Skin was white), PAIN (Everything hurt so bad.), PAIN OF SKIN (Just touching my skin hurt.) and ILLNESS (The first one made me extremely sick) in a 49-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. D45C21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     The patient's past medical history included COVID-19 in December 2020.    On 30-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 DIARRHOEA (Diarrhea since got the first shot), SKIN DISCOLOURATION (Skin was white), PAIN (Everything hurt so bad.), PAIN OF SKIN (Just touching my skin hurt.), ILLNESS (The first one made me extremely sick), FEELING ABNORMAL (I thought I would die), HEADACHE (Headache), PYREXIA (Temperature was 99.7°F), CHILLS (Chills/was so cold that needed to enter the shower with hot water) and FEELING COLD (Feeling cold). The patient was treated with PARACETAMOL (TYLENOL [PARACETAMOL]) ongoing since an unknown date for Adverse event, at an unspecified dose and frequency. At the time of the report, DIARRHOEA (Diarrhea since got the first shot) and HEADACHE (Headache) had not resolved and SKIN DISCOLOURATION (Skin was white), PAIN (Everything hurt so bad.), PAIN OF SKIN (Just touching my skin hurt.), ILLNESS (The first one made me extremely sick), FEELING ABNORMAL (I thought I would die), PYREXIA (Temperature was 99.7°F), CHILLS (Chills/was so cold that needed to enter the shower with hot water) and FEELING COLD (Feeling cold) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, Body temperature: 99.7°f (High) High.     The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       About the concomitant medications The patient stated that she is taking some gastrointestinal stuff and something to help digest the food.Been taking medicines and homeopathic   This case was linked to MOD-2021-369270 (Patient Link).
Age: 61.0
Sex: M
Vaccine: COVID19
Symptoms: Fear, Inappropriate schedule of product administration, Inguinal mass, Limb discomfort, Pain
Clinical narrative: terrified; pain; feels like its an open wound on his right thigh; stomach has an egg; First shot on 13Aug2021, Second shot on 03Sep2021; This spontaneous case was reported by a consumer and describes the occurrence of INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (First shot on 13Aug2021, Second shot on 03Sep2021), FEAR (terrified), PAIN (pain), LIMB DISCOMFORT (feels like its an open wound on his right thigh) and INGUINAL MASS (stomach has an egg) in a 61-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. FD0A09 and 1775978. FC3180) for COVID-19 vaccination.     Concurrent medical conditions included Blood pressure.   On 13-Aug-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 03-Sep-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 03-Sep-2021,  after starting mRNA-1273 (Moderna COVID-19 Vaccine), the patient experienced INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (First shot on 13Aug2021, Second shot on 03Sep2021). On an unknown date, the patient experienced FEAR (terrified), PAIN (pain), LIMB DISCOMFORT (feels like its an open wound on his right thigh) and INGUINAL MASS (stomach has an egg). On 03-Sep-2021, INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (First shot on 13Aug2021, Second shot on 03Sep2021) had resolved. At the time of the report, FEAR (terrified), PAIN (pain), LIMB DISCOMFORT (feels like its an open wound on his right thigh) and INGUINAL MASS (stomach has an egg) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   Concomitant medications included blood pressure medications. Treatment medication stated Aleve and cold compresses which was used for events related to Dose 1 and also include t already went to ER and his doctor and had an X-ray and sonogram and an MRI but they found nothin in there. Said that he will be seeing his doctor tomorrow morning and  ask for a pain killer and antibiotic.   This case was linked to MOD-2021-368988 (Patient Link).   Most recent FOLLOW-UP information incorporated above includes: On 31-Oct-2021: Significant follow-up appended include events added.
Age: 55.0
Sex: F
Vaccine: COVID19
Symptoms: Expired product administered
Clinical narrative: The patient received a dose from a vial more than 30 days on the fridge; This spontaneous case was reported by a pharmacist and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (The patient received a dose from a vial more than 30 days on the fridge) in a 55-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 014C21A and 014C21A) for COVID-19 vaccination.     No Medical History information was reported.   On 19-May-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 16-Jun-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 16-Jun-2021,  after starting mRNA-1273 (Moderna COVID-19 Vaccine), the patient experienced EXPIRED PRODUCT ADMINISTERED (The patient received a dose from a vial more than 30 days on the fridge). On 16-Jun-2021, EXPIRED PRODUCT ADMINISTERED (The patient received a dose from a vial more than 30 days on the fridge) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   HCP mentioned that there were 14 patients instead of 18 because of some duplicates.  No relevant concomitant medications were reported.  No treatment information was provided.   This case was linked to MOD-2021-369249 (Patient Link).   Most recent FOLLOW-UP information incorporated above includes: On 02-Nov-2021: Addition information received included new reporter information, race information, pregnancy information, ethnic group, route of administration and site of administration. On 02-Nov-2021: Addition information received  included the information that the HCP confirm number of patients.
Age: 67.0
Sex: F
Vaccine: COVID19
Symptoms: Expired product administered
Clinical narrative: patient was administered an expired booster dose; This spontaneous case was reported by a pharmacist and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (patient was administered an expired booster dose) in a 68-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 033C21A) for COVID-19 vaccination.     No Medical History information was reported.    On 29-Oct-2021, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 29-Oct-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (patient was administered an expired booster dose). On 29-Oct-2021, EXPIRED PRODUCT ADMINISTERED (patient was administered an expired booster dose) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   Concomitant medication information was not provided by the reporter. Treatment information was not provided by the reporter.   This case was linked to MOD-2021-369020 (Patient Link).
Age: 64.0
Sex: F
Vaccine: COVID19
Symptoms: Pyrexia
Clinical narrative: Fever; This spontaneous case was reported by a consumer and describes the occurrence of PYREXIA (Fever) in a 64-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.   On 11-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 09-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 25-Oct-2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. In October 2021,  after starting mRNA-1273 (Moderna COVID-19 Vaccine), the patient experienced PYREXIA (Fever). The patient was treated with PARACETAMOL (TYLENOL [PARACETAMOL]) for Fever, at an unspecified dose and frequency. On 30-Oct-2021, PYREXIA (Fever) had resolved.            No Concomitant medication was reported.  No treatment medications were reported.
Age: 76.0
Sex: M
Vaccine: COVID19
Symptoms: Peripheral swelling
Clinical narrative: arm is tight; This spontaneous case was reported by a consumer and describes the occurrence of PERIPHERAL SWELLING (arm is tight) in a 77-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 011A21A and 029K20A) for COVID-19 vaccination.     No Medical History information was reported.   On 01-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 01-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient experienced PERIPHERAL SWELLING (arm is tight). At the time of the report, PERIPHERAL SWELLING (arm is tight) outcome was unknown.            Concomitant drugs were not reported. Treatment medications were not provided.   This case was linked to MOD-2021-369375, MOD-2021-369392 (Patient Link).
Age: 75.0
Sex: F
Vaccine: COVID19
Symptoms: Rash erythematous, Rash pruritic, Skin exfoliation, Vaccination site erythema
Clinical narrative: red rash/that has stayed red/good size rash; Patient reports now her skin is peeling from the layers of the cream; that has stayed red and very itchy. red rash/stayed red; This spontaneous case was reported by a consumer and describes the occurrence of RASH ERYTHEMATOUS (red rash/that has stayed red/good size rash), SKIN EXFOLIATION (Patient reports now her skin is peeling from the layers of the cream), RASH PRURITIC (that has stayed red and very itchy.) and VACCINATION SITE ERYTHEMA (red rash/stayed red) in a 75-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 026021A, 039K20A and 028L20A) for COVID-19 vaccination.     No medical history was provide by the reporter.  Concomitant products included SIMVASTATIN for Hypercholesteremia, LEVOTHYROXINE SODIUM (SYNTHROID) for Thyroid disorder, PARACETAMOL (TYLENOL [PARACETAMOL]) for an unknown indication.   On 26-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 23-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 27-Oct-2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 27-Oct-2021, the patient experienced RASH ERYTHEMATOUS (red rash/that has stayed red/good size rash), SKIN EXFOLIATION (Patient reports now her skin is peeling from the layers of the cream), RASH PRURITIC (that has stayed red and very itchy.) and VACCINATION SITE ERYTHEMA (red rash/stayed red). The patient was treated with HYDROCORTISONE for Itch, at an unspecified dose and frequency. At the time of the report, RASH ERYTHEMATOUS (red rash/that has stayed red/good size rash), SKIN EXFOLIATION (Patient reports now her skin is peeling from the layers of the cream), RASH PRURITIC (that has stayed red and very itchy.) and VACCINATION SITE ERYTHEMA (red rash/stayed red) outcome was unknown.            Most recent FOLLOW-UP information incorporated above includes: On 01-Nov-2021: Added new event ( skin peeling) and reporter details, patient demographic details, concomitant medications ( Tylenol, Synthroid, simvastatin), 1st and 2nd dose start dates and lot numbers,3rd dose lot number.
Age: 66.0
Sex: M
Vaccine: COVID19
Symptoms: Accidental underdose, Arthralgia, Incorrect dose administered
Clinical narrative: Sore shoulder; Patient believe he received the wrong amount for the first dose; Patient believe he received the wrong amount for the first dose/He stated on his immunization the 1st he received is 0.5ml 50 mcg; This spontaneous case was reported by a consumer and describes the occurrence of INCORRECT DOSE ADMINISTERED (Patient believe he received the wrong amount for the first dose), ACCIDENTAL UNDERDOSE (Patient believe he received the wrong amount for the first dose/He stated on his immunization the 1st he received is 0.5ml 50 mcg) and ARTHRALGIA (Sore shoulder) in a 66-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 031M20A) for COVID-19 vaccination.     No Medical History was provided by reporter.  Concomitant products included APIXABAN (ELIQUIS) from 15-Feb-2021 to an unknown date for an unknown indication.    On 15-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 50 mcg. On 15-Mar-2021, the patient experienced INCORRECT DOSE ADMINISTERED (Patient believe he received the wrong amount for the first dose) and ACCIDENTAL UNDERDOSE (Patient believe he received the wrong amount for the first dose/He stated on his immunization the 1st he received is 0.5ml 50 mcg). On an unknown date, the patient experienced ARTHRALGIA (Sore shoulder). On 15-Mar-2021, INCORRECT DOSE ADMINISTERED (Patient believe he received the wrong amount for the first dose) and ACCIDENTAL UNDERDOSE (Patient believe he received the wrong amount for the first dose/He stated on his immunization the 1st he received is 0.5ml 50 mcg) had resolved. At the time of the report, ARTHRALGIA (Sore shoulder) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No treatment medication was provided.   This case was linked to MOD-2021-369453, MOD-2021-369454 (Patient Link).   Most recent FOLLOW-UP information incorporated above includes: On 29-Oct-2021: Significant Follow up - event added On 02-Nov-2021: followup appended contains patient dose details, event updates, patient demographic updates, concomitant drug updates, reporter updates
Age: 74.0
Sex: M
Vaccine: COVID19
Symptoms: Gait disturbance, Headache
Clinical narrative: light headache; my legs wouldn't work started in the morning when I woke up/"woke up the next morning and my legs wouldn't work; This spontaneous case was reported by a consumer and describes the occurrence of GAIT DISTURBANCE (my legs wouldn't work started in the morning when I woke up/"woke up the next morning and my legs wouldn't work) and HEADACHE (light headache) in a 74-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.   On 21-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 18-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 19-Feb-2021,  after starting mRNA-1273 (Moderna COVID-19 Vaccine), the patient experienced GAIT DISTURBANCE (my legs wouldn't work started in the morning when I woke up/"woke up the next morning and my legs wouldn't work). On an unknown date, the patient experienced HEADACHE (light headache). On 19-Feb-2021, GAIT DISTURBANCE (my legs wouldn't work started in the morning when I woke up/"woke up the next morning and my legs wouldn't work) had resolved. At the time of the report, HEADACHE (light headache) outcome was unknown.            Concomitant medications were not provided.  Treatment information was not provided.   This case was linked to MOD-2021-369149 (Patient Link).   Most recent FOLLOW-UP information incorporated above includes: On 02-Nov-2021: Follow up Appended- Event dates updated - contact info, patient details updated and suspect dates updated.
Age: 67.0
Sex: F
Vaccine: COVID19
Symptoms: Antibody test, Arthralgia, Myalgia
Clinical narrative: affecting multiple areas at the same time Hip wrists shoulders knee; experiencing worse myalgic pain in multiple areas such as Hip, wrist, shoulder, knee; This spontaneous case was reported by a consumer and describes the occurrence of ARTHRALGIA (affecting multiple areas at the same time Hip wrists shoulders knee) and MYALGIA (experiencing worse myalgic pain in multiple areas such as Hip, wrist, shoulder, knee) in a 67-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 second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced ARTHRALGIA (affecting multiple areas at the same time Hip wrists shoulders knee) and MYALGIA (experiencing worse myalgic pain in multiple areas such as Hip, wrist, shoulder, knee). At the time of the report, ARTHRALGIA (affecting multiple areas at the same time Hip wrists shoulders knee) and MYALGIA (experiencing worse myalgic pain in multiple areas such as Hip, wrist, shoulder, knee) had not resolved. Not Provided    DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, Antibody test: over the highest level High.     The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No concomitant medication was provided.  No treatment medication was provided.  No medical history was provided.   This case was linked to MOD-2021-024393 (Patient Link).
Sex: F
Vaccine: COVID19
Symptoms: Headache
Clinical narrative: headache; This spontaneous case was reported by a consumer and describes the occurrence of HEADACHE (headache) 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 24-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 21-May-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 HEADACHE (headache). At the time of the report, HEADACHE (headache) outcome was unknown.            Patient had already been on Qulipta for 7 days and had 1 to 2 headaches since taking it. Patient had taken 60 mg. Does not have the lot number.  No concomitant medication details were provided.  No treatment medication details were provided.
Age: 13.0
Sex: U
Vaccine: COVID19
Symptoms: Product administered to patient of inappropriate age
Clinical narrative: 13 year old was administered Moderna instead of Pfizer; This spontaneous case was reported by a non-health professional and describes the occurrence of PRODUCT ADMINISTERED TO PATIENT OF INAPPROPRIATE AGE (13 year old was administered Moderna instead of Pfizer) in a 13-year-old patient of an unknown 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 PRODUCT ADMINISTERED TO PATIENT OF INAPPROPRIATE AGE (13 year old was administered Moderna instead of Pfizer). At the time of the report, PRODUCT ADMINISTERED TO PATIENT OF INAPPROPRIATE AGE (13 year old was administered Moderna instead of Pfizer) had resolved. Not Provided          No concomitant medication was reported No treatment medication was reported
Age: 43.0
Sex: F
Vaccine: COVID19
Symptoms: Axillary mass, Fatigue, Injection site erythema, Pain, Tenderness
Clinical narrative: soreness and red bump at injection site; I felt swelling under my left armpit, feels like a cushion is there/ red bump at injection site; I have fatigue, soreness and red bump at injection site; The armpit feels tender and raw; I have fatigue; The armpit feels sore/ soreness; This spontaneous case was reported by a consumer and describes the occurrence of AXILLARY MASS (I felt swelling under my left armpit, feels like a cushion is there/ red bump at injection site), PAIN (I have fatigue, soreness and red bump at injection site), TENDERNESS (The armpit feels tender and raw), FATIGUE (I have fatigue) and VACCINATION SITE PAIN (The armpit feels sore/ soreness) in a 44-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 036A21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.    On 07-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced AXILLARY MASS (I felt swelling under my left armpit, feels like a cushion is there/ red bump at injection site), PAIN (I have fatigue, soreness and red bump at injection site), TENDERNESS (The armpit feels tender and raw), FATIGUE (I have fatigue), VACCINATION SITE PAIN (The armpit feels sore/ soreness) and INJECTION SITE ERYTHEMA (soreness and red bump at injection site   ). At the time of the report, AXILLARY MASS (I felt swelling under my left armpit, feels like a cushion is there/ red bump at injection site), PAIN (I have fatigue, soreness and red bump at injection site), TENDERNESS (The armpit feels tender and raw), FATIGUE (I have fatigue), VACCINATION SITE PAIN (The armpit feels sore/ soreness) and INJECTION SITE ERYTHEMA (soreness and red bump at injection site   ) 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 treatment and concomitant drugs was provided
Age: 43.0
Sex: F
Vaccine: COVID19
Symptoms: Vaccination site pain
Clinical narrative: soreness and red bump at injection site; I felt swelling under my left armpit, feels like a cushion is there/ red bump at injection site; I have fatigue, soreness and red bump at injection site; The armpit feels tender and raw; I have fatigue; The armpit feels sore/ soreness; This spontaneous case was reported by a consumer and describes the occurrence of AXILLARY MASS (I felt swelling under my left armpit, feels like a cushion is there/ red bump at injection site), PAIN (I have fatigue, soreness and red bump at injection site), TENDERNESS (The armpit feels tender and raw), FATIGUE (I have fatigue) and VACCINATION SITE PAIN (The armpit feels sore/ soreness) in a 44-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 036A21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.    On 07-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced AXILLARY MASS (I felt swelling under my left armpit, feels like a cushion is there/ red bump at injection site), PAIN (I have fatigue, soreness and red bump at injection site), TENDERNESS (The armpit feels tender and raw), FATIGUE (I have fatigue), VACCINATION SITE PAIN (The armpit feels sore/ soreness) and INJECTION SITE ERYTHEMA (soreness and red bump at injection site   ). At the time of the report, AXILLARY MASS (I felt swelling under my left armpit, feels like a cushion is there/ red bump at injection site), PAIN (I have fatigue, soreness and red bump at injection site), TENDERNESS (The armpit feels tender and raw), FATIGUE (I have fatigue), VACCINATION SITE PAIN (The armpit feels sore/ soreness) and INJECTION SITE ERYTHEMA (soreness and red bump at injection site   ) 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 treatment and concomitant drugs was provided
Sex: U
Vaccine: COVID19
Symptoms: COVID-19
Clinical narrative: People being treated in hospital for COVID with both vaccines given; Based on the current case data, this case has been classified as invalid. This spontaneous case was reported by a consumer and describes the occurrence of COVID-19 (People being treated in hospital for COVID with both vaccines given) 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 (People being treated in hospital for COVID with both vaccines given) (seriousness criterion hospitalization). At the time of the report, COVID-19 (People being treated in hospital for COVID with both vaccines given) outcome was unknown.            No concomitant medications were reported. No treatment medications were reported. Company Comment : This is a case of unspecified number of patients of an unknown age and gender who experienced serious unexpected event of special interest COVID-19. Temporal relationship cannot be determined as start date of the event was not provided nor vaccination dates. The event occurred following the second dose with the Moderna COVID-19 vaccine. The rechallenge was not applicable as the event occurred following the second dose. Very limited information regarding the event has been provided at this time. Outcome of the event was unknown. The benefit-risk relationship of Moderna COVID-19 vaccine is not affected by this report.; Sender's Comments: This is a case of unspecified number of patients of an unknown age and gender who experienced serious unexpected event of special interest COVID-19. Temporal relationship cannot be determined as start date of the event was not provided nor vaccination dates. The event occurred following the second dose with the Moderna COVID-19 vaccine. The rechallenge was not applicable as the event occurred following the second dose. Very limited information regarding the event has been provided at this time. Outcome of the event was unknown. The benefit-risk relationship of Moderna COVID-19 vaccine is not affected by this report.
Age: 41.0
Sex: M
Vaccine: COVID19
Symptoms: Feeling cold, Hyperhidrosis, Hypersomnia, Insomnia, Myalgia
Clinical narrative: slept even more; broke out into a deep deep sweat; he felt like he had a fever of 100.6; body aches all over; got really cold; couldn't sleep; This spontaneous case was reported by a consumer and describes the occurrence of FEELING COLD (got really cold), INSOMNIA (couldn't sleep), HYPERSOMNIA (slept even more), HYPERHIDROSIS (broke out into a deep deep sweat) and PYREXIA (he felt like he had a fever of 100.6) in a 41-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 051F21A, 003B21A and 001C21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.   On 02-Apr-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 30-Apr-2021, received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 30-Oct-2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 30-Oct-2021, the patient experienced FEELING COLD (got really cold), INSOMNIA (couldn't sleep), PYREXIA (he felt like he had a fever of 100.6) and MYALGIA (body aches all over). On 31-Oct-2021, the patient experienced HYPERSOMNIA (slept even more) and HYPERHIDROSIS (broke out into a deep deep sweat). The patient was treated with IBUPROFEN for Adverse event, at an unspecified dose and frequency. At the time of the report, FEELING COLD (got really cold), INSOMNIA (couldn't sleep), HYPERSOMNIA (slept even more), HYPERHIDROSIS (broke out into a deep deep sweat), PYREXIA (he felt like he had a fever of 100.6) and MYALGIA (body aches all over) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant medications reported by reporter All three doses were given in his deltoid muscle.  Company Comment - This case concerns a 41-year-old male patient, with no relevant medical history, who experienced the non-serious unexpected AESI of HYPERSOMNIA. The event occurred on the day after receiving a third dose of Moderna COVID-19 vaccine. The rechallenge is not applicable since the outcome of the event is unknown and no further dose is expected at this time. The benefit-risk relation of Moderna COVID-19 vaccine is not affected by this report.   Most recent FOLLOW-UP information incorporated above includes: On 02-Nov-2021: Follow up added events, reporter details and updated vaccination information.; Sender's Comments: This case concerns a 41-year-old male patient, with no relevant medical history, who experienced the non-serious unexpected AESI of HYPERSOMNIA. The event occurred on the day after receiving a third dose of Moderna COVID-19 vaccine. The rechallenge is not applicable since the outcome of the event is unknown and no further dose is expected at this time. The benefit-risk relation of Moderna COVID-19 vaccine is not affected by this report.
Age: 41.0
Sex: M
Vaccine: COVID19
Symptoms: Pyrexia
Clinical narrative: slept even more; broke out into a deep deep sweat; he felt like he had a fever of 100.6; body aches all over; got really cold; couldn't sleep; This spontaneous case was reported by a consumer and describes the occurrence of FEELING COLD (got really cold), INSOMNIA (couldn't sleep), HYPERSOMNIA (slept even more), HYPERHIDROSIS (broke out into a deep deep sweat) and PYREXIA (he felt like he had a fever of 100.6) in a 41-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 051F21A, 003B21A and 001C21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.   On 02-Apr-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 30-Apr-2021, received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 30-Oct-2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 30-Oct-2021, the patient experienced FEELING COLD (got really cold), INSOMNIA (couldn't sleep), PYREXIA (he felt like he had a fever of 100.6) and MYALGIA (body aches all over). On 31-Oct-2021, the patient experienced HYPERSOMNIA (slept even more) and HYPERHIDROSIS (broke out into a deep deep sweat). The patient was treated with IBUPROFEN for Adverse event, at an unspecified dose and frequency. At the time of the report, FEELING COLD (got really cold), INSOMNIA (couldn't sleep), HYPERSOMNIA (slept even more), HYPERHIDROSIS (broke out into a deep deep sweat), PYREXIA (he felt like he had a fever of 100.6) and MYALGIA (body aches all over) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant medications reported by reporter All three doses were given in his deltoid muscle.  Company Comment - This case concerns a 41-year-old male patient, with no relevant medical history, who experienced the non-serious unexpected AESI of HYPERSOMNIA. The event occurred on the day after receiving a third dose of Moderna COVID-19 vaccine. The rechallenge is not applicable since the outcome of the event is unknown and no further dose is expected at this time. The benefit-risk relation of Moderna COVID-19 vaccine is not affected by this report.   Most recent FOLLOW-UP information incorporated above includes: On 02-Nov-2021: Follow up added events, reporter details and updated vaccination information.; Sender's Comments: This case concerns a 41-year-old male patient, with no relevant medical history, who experienced the non-serious unexpected AESI of HYPERSOMNIA. The event occurred on the day after receiving a third dose of Moderna COVID-19 vaccine. The rechallenge is not applicable since the outcome of the event is unknown and no further dose is expected at this time. The benefit-risk relation of Moderna COVID-19 vaccine is not affected by this report.
Age: 66.0
Sex: F
Vaccine: COVID19
Symptoms: Abdominal discomfort, Arthralgia, Chills, Headache, Myalgia
Clinical narrative: Upset stomach; Muscle ache/ aches; Joint ache; Low grade fever; Chills; Nausea; Headache; This spontaneous case was reported by a consumer and describes the occurrence of ABDOMINAL DISCOMFORT (Upset stomach), MYALGIA (Muscle ache/ aches), ARTHRALGIA (Joint ache), PYREXIA (Low grade fever) and CHILLS (Chills) in a 67-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 033F21A, 0Z9LZ0A and 030MZ0A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.  No medical history was provided by the reporter. Concomitant products included FLUTICASONE FUROATE, UMECLIDINIUM BROMIDE, VILANTEROL TRIFENATATE (TRELEGY) for an unknown indication. On 18-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 15-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 29-Oct-2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient experienced ABDOMINAL DISCOMFORT (Upset stomach), MYALGIA (Muscle ache/ aches), ARTHRALGIA (Joint ache), PYREXIA (Low grade fever), CHILLS (Chills), NAUSEA (Nausea) and HEADACHE (Headache). The patient was treated with IBUPROFEN for Adverse event, at an unspecified dose and frequency; PARACETAMOL (TYLENOL [PARACETAMOL]) for Adverse event, at an unspecified dose and frequency and DIMENHYDRINATE (DRAMAMINE) for Adverse event, at an unspecified dose and frequency. At the time of the report, ABDOMINAL DISCOMFORT (Upset stomach) and HEADACHE (Headache) outcome was unknown and MYALGIA (Muscle ache/ aches), ARTHRALGIA (Joint ache), PYREXIA (Low grade fever), CHILLS (Chills) and NAUSEA (Nausea) had not resolved. For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments. This case was linked to MOD-2021-023646 (Patient Link).
Age: 66.0
Sex: F
Vaccine: COVID19
Symptoms: Nausea, Pyrexia
Clinical narrative: Upset stomach; Muscle ache/ aches; Joint ache; Low grade fever; Chills; Nausea; Headache; This spontaneous case was reported by a consumer and describes the occurrence of ABDOMINAL DISCOMFORT (Upset stomach), MYALGIA (Muscle ache/ aches), ARTHRALGIA (Joint ache), PYREXIA (Low grade fever) and CHILLS (Chills) in a 67-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 033F21A, 0Z9LZ0A and 030MZ0A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.  No medical history was provided by the reporter. Concomitant products included FLUTICASONE FUROATE, UMECLIDINIUM BROMIDE, VILANTEROL TRIFENATATE (TRELEGY) for an unknown indication. On 18-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 15-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 29-Oct-2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient experienced ABDOMINAL DISCOMFORT (Upset stomach), MYALGIA (Muscle ache/ aches), ARTHRALGIA (Joint ache), PYREXIA (Low grade fever), CHILLS (Chills), NAUSEA (Nausea) and HEADACHE (Headache). The patient was treated with IBUPROFEN for Adverse event, at an unspecified dose and frequency; PARACETAMOL (TYLENOL [PARACETAMOL]) for Adverse event, at an unspecified dose and frequency and DIMENHYDRINATE (DRAMAMINE) for Adverse event, at an unspecified dose and frequency. At the time of the report, ABDOMINAL DISCOMFORT (Upset stomach) and HEADACHE (Headache) outcome was unknown and MYALGIA (Muscle ache/ aches), ARTHRALGIA (Joint ache), PYREXIA (Low grade fever), CHILLS (Chills) and NAUSEA (Nausea) had not resolved. For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments. This case was linked to MOD-2021-023646 (Patient Link).
Age: 66.0
Sex: M
Vaccine: COVID19
Symptoms: Ventricular extrasystoles
Clinical narrative: Had PVCs; This spontaneous case was reported by a consumer and describes the occurrence of VENTRICULAR EXTRASYSTOLES (Had PVCs) in a 66-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 013M20A and 029L20A) for COVID-19 vaccination.     The patient's past medical history included Premature ventricular contractions (Caffeine related.).   On 22-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 19-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 VENTRICULAR EXTRASYSTOLES (Had PVCs). At the time of the report, VENTRICULAR EXTRASYSTOLES (Had PVCs) had resolved.            The patient also stated that previously had PVC but they had been caffeine related. Patient also stated that had been reading about myocarditis and the vaccine and wondered if patient should do some more investigation before receiving vaccine.   Symptoms resolved in 3-5 days without medical attention/treatment No concomitant medications were reported  No treatment information was provided  This is a spontaneous case concerning a 66-year-old male patient with relevant medical history of Premature ventricular contractions (caffeine related), who experienced non serious, AESI, unexpected event of Ventricular extrasystoles. The event occurred unknown days after the second dose of mRNA-1273. The event resolved in 3-5 days without medical attention/treatment.  Diagnostic tests were not performed. Rechallenge is not applicable. Medical history of Premature ventricular contractions remains a confounder. The benefit-risk relationship of mRNA-1273 is not affected by this report.   This case was linked to MOD-2021-370430 (Patient Link). Sender's Comments: This is a spontaneous case concerning a 66-year-old male patient with relevant medical history of Premature ventricular contractions (caffeine related), who experienced non serious, AESI, unexpected event of Ventricular extrasystoles. The event occurred unknown days after the second dose of mRNA-1273. The event resolved in 3-5 days without medical attention/treatment.  Diagnostic tests were not performed. Rechallenge is not applicable. Medical history of Premature ventricular contractions remains a confounder. The benefit-risk relationship of mRNA-1273 is not affected by this report.
Sex: U
Vaccine: COVID19
Symptoms: Expired product administered
Clinical narrative: 30 patients received dose from vial punctured 30 times; 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 (30 patients received dose from vial punctured 30 times) in a  patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 039F21A) for COVID-19 vaccination.     No Medical History information was reported.  On 29-Oct-2021, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) .25 milliliter. On 29-Oct-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (30 patients received dose from vial punctured 30 times). On 29-Oct-2021, EXPIRED PRODUCT ADMINISTERED (30 patients received dose from vial punctured 30 times) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No relevant concomitant medications was reported. Treatment information was not provided.
Age: 56.0
Sex: M
Vaccine: COVID19
Symptoms: Fall, Loss of consciousness
Clinical narrative: Patient total blacked out and fall.  He has not awareness of the occurrance.
Age: 55.0
Sex: F
Vaccine: COVID19
Symptoms: Injection site pain, Joint range of motion decreased, Mobility decreased, Muscular weakness, Myalgia
Clinical narrative: left deltoid disabling pain and use of muscle, decreased abduction of shoulder and arm. Tenderness over injection site, decreased range of motion with progressive weakness in left arm
Age: 24.0
Sex: M
Vaccine: COVID19
Symptoms: Chest pain, Dyspnoea, Troponin increased
Clinical narrative: chest pain shortness of breath, Sensitivity troponin level greater than 1000 concerning for myocarditis vs myocardial infarction
Age: 22.0
Sex: M
Vaccine: COVID19
Symptoms: Chest X-ray normal, Chest pain, Electrocardiogram abnormal, Palpitations
Clinical narrative: A few weeks after first dose patient thought he had some chest pain but thought he was just imagining it; after second dose developed chest pain, doe and palpitations; ecg shows st elevations throughout; referred for echo, holter and cardiology appt
Age: 22.0
Sex: M
Vaccine: COVID19
Symptoms: Dizziness, Headache, Myalgia, Nausea
Clinical narrative: muscle aches in back and legs, headache, nausea, and lightheadedness
Age: 27.0
Sex: F
Vaccine: COVID19
Symptoms: Arthralgia, Chills, Myalgia, Nausea, Pain
Clinical narrative: Fever, chills, nausea, body aches (I.e. muscle, joint pain) Tylenol  11/6 symptoms were the worse 11/7 symptoms improved still not ok 11/8 symptoms in morning - mild
Age: 27.0
Sex: F
Vaccine: COVID19
Symptoms: Pyrexia
Clinical narrative: Fever, chills, nausea, body aches (I.e. muscle, joint pain) Tylenol  11/6 symptoms were the worse 11/7 symptoms improved still not ok 11/8 symptoms in morning - mild
Age: 33.0
Sex: F
Vaccine: COVID19, FLU4
Symptoms: Injection site pain, Night sweats
Clinical narrative: Night sweats (three days in a row), arm soreness at injection site
Sex: F
Vaccine: MMR
Symptoms: Therapy non-responder
Clinical narrative: when she drew titers on the patient, she was not immune; when she drew titers on the patient, she was not immune; when she drew titers on the patient, she was not immune; This spontaneous report as received from a nurse practitioner refers to a 24-year-old female patient. There was no information about the patient's concurrent conditions, concomitant therapies or medical history provided.  On an unknown date, when the patient was a child, she was vaccinated with measles, mumps, and rubella (wistar ra 27-3) virus vaccine, live(M-M-R II), 0.5 milliliter, subcutaneous (lot # and expiration date were not reported) for routine vaccination.        On an unknown date, the patient had drew titers on her and she was not immune.  The outcome of the event was not reported. Causality assessment was not provided.
Age: 7.0
Sex: M
Vaccine: HPV9
Symptoms: No adverse event, Product administered to patient of inappropriate age
Clinical narrative: No other AEs or PQC reported; GARDASIL 9 was administered to 7 year old male.; This spontaneous report was received from a nurse and refers to a 7 years old male patient. No information regarding the patient's pertinent medical history, drug reactions or allergies and concomitant therapies was provided.   On 05-OCT-2021, the patient was vaccinated with hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast) (GARDASIL 9) 0.5 ml, intramuscularly, lot # T030746, expiration date 16-MAR-2023, for prophylaxis (anatomical location was not reported) (product administered to patient of inappropriate age).    No other adverse event reported.
Sex: M
Vaccine: HEPA
Symptoms: Expired product administered, No adverse event
Clinical narrative: No additional AE; Nurse reported an expired dose of V AQT A was administered to a patient; This spontaneous report was received from a nurse referring to a 57 years old male patient. The patient's medical history, concurrent conditions, historical drugs and concomitant medications were unknown.  On 28-OCT-2021, the patient was vaccinated with an expired dose of hepatitis a vaccine, inactivated (VAQTA) (lot # T017179, expiration date 26-OCT-2021; strength, dose, route were not reported) once in right arm for prophylaxis (expired product administered). No events have occurred at this time as a result of the expired vaccine administration. The patient has not sought any medical treatment. The reporter had no additional information at this time (no adverse event).