chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 72.0
Sex: M
Vaccine: COVID19
Symptoms: Fatigue
Clinical narrative: Relatively mild fatigue after 2nd shot; This spontaneous case was reported by a consumer and describes the occurrence of FATIGUE (Relatively mild fatigue after 2nd shot) in a 72-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 037A21B and 040A21A) for COVID-19 vaccination.     No Medical History information was reported.   On 12-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 09-Apr-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 FATIGUE (Relatively mild fatigue after 2nd shot). At the time of the report, FATIGUE (Relatively mild fatigue after 2nd shot) outcome was unknown.            Concomitant medication was not reported.  Treatment include Anti histamines and steroids.   This case was linked to MOD-2021-416023 (Link).
Sex: M
Vaccine: COVID19
Symptoms: Inappropriate schedule of product administration
Clinical narrative: He got his first two doses in September and received his booster dose yesterday.; This spontaneous case was reported by a consumer and describes the occurrence of INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (He got his first two doses in September and received his booster dose yesterday.) in a male patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.   In September 2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. In September 2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 15-Dec-2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 15-Dec-2021, the patient experienced INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (He got his first two doses in September and received his booster dose yesterday.). On 15-Dec-2021, INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (He got his first two doses in September and received his booster dose yesterday.) had resolved.            No concomitant medications were reported.  No treatment medications were reported.
Sex: U
Vaccine: COVID19
Symptoms: Accidental underdose
Clinical narrative: 0.25 mL dose was administered instead of 0.5 mL. It was suppose to be consumer's 2nd Moderna dose.; This spontaneous case was reported by a pharmacist and describes the occurrence of ACCIDENTAL UNDERDOSE (0.25 mL dose was administered instead of 0.5 mL. It was suppose to be consumer's 2nd Moderna dose.) 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 15-Dec-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) .25 ml. On 15-Dec-2021, the patient experienced ACCIDENTAL UNDERDOSE (0.25 mL dose was administered instead of 0.5 mL. It was suppose to be consumer's 2nd Moderna dose.). On 15-Dec-2021, ACCIDENTAL UNDERDOSE (0.25 mL dose was administered instead of 0.5 mL. It was suppose to be consumer's 2nd Moderna dose.) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   Concomitant information was not provided. Treatment information was not provided.
Age: 53.0
Sex: F
Vaccine: COVID19
Symptoms: Pruritus, Urticaria
Clinical narrative: Two weeks after booster, she started itching all over body; Two weeks after booster she had hives all over the body; This spontaneous case was reported by an other health care professional and describes the occurrence of PRURITUS (Two weeks after booster, she started itching all over body) and URTICARIA (Two weeks after booster she had hives all over the body) in a 53-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 077C21B, 031L20A and 034K20A) for COVID-19 vaccination.     Concurrent medical conditions included Asthma.   On 05-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 01-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 29-Oct-2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 12-Nov-2021, the patient experienced PRURITUS (Two weeks after booster, she started itching all over body) and URTICARIA (Two weeks after booster she had hives all over the body). The patient was treated with FEXOFENADINE HYDROCHLORIDE (ALLEGRA 24 HOUR) for Pruritus and Hives, at an unspecified dose and frequency. At the time of the report, PRURITUS (Two weeks after booster, she started itching all over body) and URTICARIA (Two weeks after booster she had hives all over the body) was resolving.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   The patient does not have any history of skin allergy . The  concomitant medications on use were not provided.  Patient visited a doctor and received Allegra 24 hour prescription medication.The symptoms were improving from 16-Dec-2021, hives was fading and the itching was better.
Age: 69.0
Sex: F
Vaccine: COVID19
Symptoms: Abdominal discomfort, Asthenia, Body temperature, Chills, Dizziness
Clinical narrative: she could barely get up; nauseas with a very upset stomach; even my eyes were sore; weak; injection site was warm to touch; slight dizziness; low-grade fever 98.8; nauseas with a very upset stomach; she was achy/very sore/muscles are sore; has a headache; the injection site was warm to touch, sore; having no energy exhausted; chills; This spontaneous case was reported by a consumer and describes the occurrence of DYSSTASIA (she could barely get up), ABDOMINAL DISCOMFORT (nauseas with a very upset stomach), EYE PAIN (even my eyes were sore), ASTHENIA (weak) and VACCINATION SITE WARMTH (injection site was warm to touch) in a 70-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 058H21A, 006B21A and 042B21-2A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.   On 20-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 15-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 15-Dec-2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 16-Dec-2021, the patient experienced DYSSTASIA (she could barely get up), ABDOMINAL DISCOMFORT (nauseas with a very upset stomach), EYE PAIN (even my eyes were sore), ASTHENIA (weak), VACCINATION SITE WARMTH (injection site was warm to touch), DIZZINESS (slight dizziness), PYREXIA (low-grade fever 98.8), NAUSEA (nauseas with a very upset stomach), MYALGIA (she was achy/very sore/muscles are sore), HEADACHE (has a headache), VACCINATION SITE PAIN (the injection site was warm to touch, sore), FATIGUE (having no energy exhausted) and CHILLS (chills). The patient was treated with ACETYLSALICYLIC ACID (BAYER ASPIRIN) for Adverse event, at an unspecified dose and frequency. At the time of the report, DYSSTASIA (she could barely get up), ABDOMINAL DISCOMFORT (nauseas with a very upset stomach), EYE PAIN (even my eyes were sore), ASTHENIA (weak), VACCINATION SITE WARMTH (injection site was warm to touch), DIZZINESS (slight dizziness), PYREXIA (low-grade fever 98.8), NAUSEA (nauseas with a very upset stomach), MYALGIA (she was achy/very sore/muscles are sore), HEADACHE (has a headache), VACCINATION SITE PAIN (the injection site was warm to touch, sore), FATIGUE (having no energy exhausted) and CHILLS (chills) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 16-Dec-2021, Body temperature: 98.8 (High) Low grade fever- 98.8.         No relevant concomitant medications were reported. Lot number of Booster dose is 058HXA most likely 058H21A.
Age: 69.0
Sex: F
Vaccine: COVID19
Symptoms: Dysstasia, Eye pain, Fatigue, Headache, Myalgia
Clinical narrative: she could barely get up; nauseas with a very upset stomach; even my eyes were sore; weak; injection site was warm to touch; slight dizziness; low-grade fever 98.8; nauseas with a very upset stomach; she was achy/very sore/muscles are sore; has a headache; the injection site was warm to touch, sore; having no energy exhausted; chills; This spontaneous case was reported by a consumer and describes the occurrence of DYSSTASIA (she could barely get up), ABDOMINAL DISCOMFORT (nauseas with a very upset stomach), EYE PAIN (even my eyes were sore), ASTHENIA (weak) and VACCINATION SITE WARMTH (injection site was warm to touch) in a 70-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 058H21A, 006B21A and 042B21-2A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.   On 20-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 15-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 15-Dec-2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 16-Dec-2021, the patient experienced DYSSTASIA (she could barely get up), ABDOMINAL DISCOMFORT (nauseas with a very upset stomach), EYE PAIN (even my eyes were sore), ASTHENIA (weak), VACCINATION SITE WARMTH (injection site was warm to touch), DIZZINESS (slight dizziness), PYREXIA (low-grade fever 98.8), NAUSEA (nauseas with a very upset stomach), MYALGIA (she was achy/very sore/muscles are sore), HEADACHE (has a headache), VACCINATION SITE PAIN (the injection site was warm to touch, sore), FATIGUE (having no energy exhausted) and CHILLS (chills). The patient was treated with ACETYLSALICYLIC ACID (BAYER ASPIRIN) for Adverse event, at an unspecified dose and frequency. At the time of the report, DYSSTASIA (she could barely get up), ABDOMINAL DISCOMFORT (nauseas with a very upset stomach), EYE PAIN (even my eyes were sore), ASTHENIA (weak), VACCINATION SITE WARMTH (injection site was warm to touch), DIZZINESS (slight dizziness), PYREXIA (low-grade fever 98.8), NAUSEA (nauseas with a very upset stomach), MYALGIA (she was achy/very sore/muscles are sore), HEADACHE (has a headache), VACCINATION SITE PAIN (the injection site was warm to touch, sore), FATIGUE (having no energy exhausted) and CHILLS (chills) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 16-Dec-2021, Body temperature: 98.8 (High) Low grade fever- 98.8.         No relevant concomitant medications were reported. Lot number of Booster dose is 058HXA most likely 058H21A.
Age: 69.0
Sex: F
Vaccine: COVID19
Symptoms: Nausea, Pyrexia, Vaccination site pain, Vaccination site warmth
Clinical narrative: she could barely get up; nauseas with a very upset stomach; even my eyes were sore; weak; injection site was warm to touch; slight dizziness; low-grade fever 98.8; nauseas with a very upset stomach; she was achy/very sore/muscles are sore; has a headache; the injection site was warm to touch, sore; having no energy exhausted; chills; This spontaneous case was reported by a consumer and describes the occurrence of DYSSTASIA (she could barely get up), ABDOMINAL DISCOMFORT (nauseas with a very upset stomach), EYE PAIN (even my eyes were sore), ASTHENIA (weak) and VACCINATION SITE WARMTH (injection site was warm to touch) in a 70-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 058H21A, 006B21A and 042B21-2A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.   On 20-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 15-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 15-Dec-2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 16-Dec-2021, the patient experienced DYSSTASIA (she could barely get up), ABDOMINAL DISCOMFORT (nauseas with a very upset stomach), EYE PAIN (even my eyes were sore), ASTHENIA (weak), VACCINATION SITE WARMTH (injection site was warm to touch), DIZZINESS (slight dizziness), PYREXIA (low-grade fever 98.8), NAUSEA (nauseas with a very upset stomach), MYALGIA (she was achy/very sore/muscles are sore), HEADACHE (has a headache), VACCINATION SITE PAIN (the injection site was warm to touch, sore), FATIGUE (having no energy exhausted) and CHILLS (chills). The patient was treated with ACETYLSALICYLIC ACID (BAYER ASPIRIN) for Adverse event, at an unspecified dose and frequency. At the time of the report, DYSSTASIA (she could barely get up), ABDOMINAL DISCOMFORT (nauseas with a very upset stomach), EYE PAIN (even my eyes were sore), ASTHENIA (weak), VACCINATION SITE WARMTH (injection site was warm to touch), DIZZINESS (slight dizziness), PYREXIA (low-grade fever 98.8), NAUSEA (nauseas with a very upset stomach), MYALGIA (she was achy/very sore/muscles are sore), HEADACHE (has a headache), VACCINATION SITE PAIN (the injection site was warm to touch, sore), FATIGUE (having no energy exhausted) and CHILLS (chills) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 16-Dec-2021, Body temperature: 98.8 (High) Low grade fever- 98.8.         No relevant concomitant medications were reported. Lot number of Booster dose is 058HXA most likely 058H21A.
Sex: M
Vaccine: COVID19
Symptoms: Burning sensation, Cough, Dyspnoea, Exposure to SARS-CoV-2, SARS-CoV-2 test
Clinical narrative: Has trouble breathing; When he breaths, it burns; Chest cough; Exposed to 2 people whom have COVID disease.; This spontaneous case was reported by a consumer and describes the occurrence of DYSPNOEA (Has trouble breathing), BURNING SENSATION (When he breaths, it burns), COUGH (Chest cough) and EXPOSURE TO SARS-COV-2 (Exposed to 2 people whom have COVID disease.) in a male patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    In 2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. In December 2021, the patient experienced EXPOSURE TO SARS-COV-2 (Exposed to 2 people whom have COVID disease.). On 16-Dec-2021, the patient experienced DYSPNOEA (Has trouble breathing), BURNING SENSATION (When he breaths, it burns) and COUGH (Chest cough). At the time of the report, DYSPNOEA (Has trouble breathing), BURNING SENSATION (When he breaths, it burns), COUGH (Chest cough) and EXPOSURE TO SARS-COV-2 (Exposed to 2 people whom have COVID disease.) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 16-Dec-2021, SARS-CoV-2 test: negative (Negative) Negative.         Concomitant information was not provided.  It was reported that the patient second dose was around Apr 2021 or May 2021.  Treatment information was not provided.
Age: 63.0
Sex: M
Vaccine: COVID19
Symptoms: Vaccination site pain, Vaccination site swelling
Clinical narrative: It hurts; Size of a dime; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE PAIN (It hurts) and VACCINATION SITE SWELLING (Size of a dime) in a 64-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 060H21A, 002A21A and 047A21A) for COVID-19 vaccination.     No Medical History information was reported.   On 26-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 26-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 15-Dec-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 VACCINATION SITE PAIN (It hurts) and VACCINATION SITE SWELLING (Size of a dime). At the time of the report, VACCINATION SITE PAIN (It hurts) and VACCINATION SITE SWELLING (Size of a dime) outcome was unknown.            No Concomitant medication was reported.    No treatment medications were reported.   This case was linked to MOD-2021-416089 (Patient Link).
Age: 72.0
Sex: F
Vaccine: COVID19
Symptoms: Chills
Clinical narrative: She experienced bad chills. She has had chills off and on.; This spontaneous case was reported by a consumer and describes the occurrence of CHILLS (She experienced bad chills. She has had chills off and on.) in a 72-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 016B21A and 028H21A) for COVID-19 vaccination.     No Medical History information was reported.   On 04-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 01-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 04-Mar-2021, the patient experienced CHILLS (She experienced bad chills. She has had chills off and on.). At the time of the report, CHILLS (She experienced bad chills. She has had chills off and on.) had not resolved.        mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) and mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) dosing remained unchanged.       Concomitant medications details were not reported by the reporter. Treatment details was not reported by the reporter.   This case was linked to MOD-2021-416098 (Patient Link).
Age: 47.0
Sex: F
Vaccine: COVID19
Symptoms: Product administration error, Underdose
Clinical narrative: Received half dose Moderna  Booster instead of the first dose; Received half dose Moderna  Booster instead of the first dose; This spontaneous case was reported by an other health care professional and describes the occurrence of UNDERDOSE (Received half dose Moderna  Booster instead of the first dose) and PRODUCT ADMINISTRATION ERROR (Received half dose Moderna  Booster instead of the first dose) in a 47-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 034F21A) for COVID-19 vaccination.     No Medical History information was reported.    On 14-Dec-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 14-Dec-2021, the patient experienced UNDERDOSE (Received half dose Moderna  Booster instead of the first dose) and PRODUCT ADMINISTRATION ERROR (Received half dose Moderna  Booster instead of the first dose). On 14-Dec-2021, UNDERDOSE (Received half dose Moderna  Booster instead of the first dose) and PRODUCT ADMINISTRATION ERROR (Received half dose Moderna  Booster instead of the first dose) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   Patient received half dose Moderna COVID-19 booster vaccine instead of the first dose. No concomitant medications were reported. No treatment medications were reported.
Age: 47.0
Sex: F
Vaccine: COVID19
Symptoms: Electrocardiogram, Palpitations
Clinical narrative: a rapid heart rate for 6months/Fast heart rate after second shot; This spontaneous case was reported by a consumer and describes the occurrence of PALPITATIONS (a rapid heart rate for 6months/Fast heart rate after second shot) in a 47-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 043B21A and 006B21A) for COVID-19 vaccination.     Concurrent medical conditions included Heart murmur.   On 22-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 21-Apr-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 PALPITATIONS (a rapid heart rate for 6months/Fast heart rate after second shot). At the time of the report, PALPITATIONS (a rapid heart rate for 6months/Fast heart rate after second shot) had resolved.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, Electrocardiogram: normal (normal) Normal.         No relevant concomitant medications were reported.  No treatment information was provided.   This case was linked to MOD-2021-416123 (Patient Link).
Age: 90.0
Sex: F
Vaccine: COVID19
Symptoms: Rash morbilliform
Clinical narrative: Had measles like rash over body after the first dose, this lasted 5 to 7 days.; This spontaneous case was reported by a consumer and describes the occurrence of RASH MORBILLIFORM (Had measles like rash over body after the first dose, this lasted 5 to 7 days.) in a 90-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 030L20A) for COVID-19 vaccination.     Concomitant products included IRBESARTAN (AVAPRO), APIXABAN (ELIQUIS), METOPROLOL, SPIRONOLACTONE and DILTIAZEM for an unknown indication.    On 22-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced RASH MORBILLIFORM (Had measles like rash over body after the first dose, this lasted 5 to 7 days.). At the time of the report, RASH MORBILLIFORM (Had measles like rash over body after the first dose, this lasted 5 to 7 days.) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No treatment medications were reported.   This case was linked to MOD-2021-416103 (Patient Link).
Age: 76.0
Sex: F
Vaccine: COVID19
Symptoms: Inappropriate schedule of product administration, Lymphadenopathy, Pain in extremity, Vaccination complication
Clinical narrative: sore arm; big round circle; swollwn enlarged lymph node; delay in getting second shot; This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (sore arm), VACCINATION COMPLICATION (big round circle), INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (delay in getting second shot) and LYMPHADENOPATHY (swollwn enlarged lymph node) in a 76-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 051F21A, 052L20A and 023M20A) for COVID-19 vaccination.     No Medical History information was reported.   On 28-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 10-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 14-Dec-2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 10-Mar-2021, the patient experienced INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (delay in getting second shot). In December 2021, the patient experienced PAIN IN EXTREMITY (sore arm), VACCINATION COMPLICATION (big round circle) and LYMPHADENOPATHY (swollwn enlarged lymph node). On 10-Mar-2021, INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (delay in getting second shot) had resolved. At the time of the report, PAIN IN EXTREMITY (sore arm), VACCINATION COMPLICATION (big round circle) and LYMPHADENOPATHY (swollwn enlarged lymph node) was resolving.            No concomitant medication was reported by the reporter. No treatment was reported by the reporter.
Age: 65.0
Sex: F
Vaccine: COVID19
Symptoms: Illness, Pain in extremity
Clinical narrative: Made her sick for a day; Sore arm; This spontaneous case was reported by a consumer and describes the occurrence of ILLNESS (Made her sick for a day) and PAIN IN EXTREMITY (Sore arm) in a 65-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     The patient's past medical history included Peritoneal dialysis since an unknown date. Concurrent medical conditions included Diabetic and Cataract (Cataract in one eye).    On an unknown date, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. In 2021, the patient experienced ILLNESS (Made her sick for a day) and PAIN IN EXTREMITY (Sore arm). In 2021, ILLNESS (Made her sick for a day) had resolved. At the time of the report, PAIN IN EXTREMITY (Sore arm) outcome was unknown.            No concomitant product use was provided. No treatment medication was provided.   This case was linked to MOD-2021-415970, MOD-2021-416208 (Patient Link).
Sex: M
Vaccine: COVID19, FLUX
Symptoms: Malaise, Pyrexia
Clinical narrative: fever; feeling sick; Initial information received on 09-Dec-2021 regarding an unsolicited valid non-serious case received from a consumer/ non-Healthcare professional.  This case involves a 30-year-old male patient who experienced feeling sick and fever after receiving vaccines INFLUENZA VACCINE and Corona virus disease (COVID-19) VACCINE MODERNA.  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.  Concomitant medications included DUPILUMAB (DUPIXENT).  On an unknown date, the patient received a dose of suspect INFLUENZA VACCINE produced by unknown manufacturer (batch number and expiry date: not reported) via unknown route in unknown administration site for prophylactic vaccination.  On an unknown date, the patient received a second booster dose of suspect Corona virus disease (COVID-19) VACCINE MODERNA not produced by Sanofi Pasteur (batch number and expiry date: not reported) via unknown route in unknown administration site for prophylactic vaccination.  On 03-Dec-2021, the patient developed a non-serious feeling sick (malaise) and fever (pyrexia) (unknown latency) following the administration of INFLUENZA VACCINE and Corona virus disease (COVID-19) VACCINE MODERNA.  It was reported " Patient called stated he got Covid booster (Moderna) and Flu vaccine about one week ago and has been feeling sick and has fever ever since. Patient stated he has similar issues after second Covid vaccine".  It is unknown if the patient experienced any additional symptoms/events.  It is unknown if there were lab data/results available.  It was not reported if the patient received a corrective treatment for the events.  At time of reporting, the outcome was reported as unknown.  There will be no information available on the batch number for this case.
Sex: M
Vaccine: COVID19, FLUX
Symptoms: Malaise, Pyrexia
Clinical narrative: feeling sick; fever; Initial information received on 09-Dec-2021 regarding an unsolicited valid non-serious case received from a consumer/ non-Healthcare professional.  This case involves a 30-year-old male patient who experienced feeling sick and fever while receiving INFLUENZA VACCINE and Corona virus disease (COVID-19) VACCINE MODERNA and while treated with DUPILUMAB [DUPIXENT].  The patient past medical history, medical treatment, vaccination and family history were not provided.   On an unknown date, the patient received a dose of suspect INFLUENZA VACCINE produced by unknown manufacturer (batch number and expiry date: not reported) via unknown route in unknown administration site for prophylactic vaccination.  On an unknown date, the patient received a second booster dose of suspect COVID-19 VACCINE MODERNA not produced by Sanofi Pasteur (batch number and expiry date: not reported) via unknown route in unknown administration site for prophylactic vaccination.  On 23-Mar-2018, the patient started taking DUPIXENT (DUPILUMAB) Solution for injection 300 mg subcutaneous (with an unknown batch number and expiry date) for Dermatitis atopic. In context of COVID19 crisis, lot number and expiry date was not requested.    On 03-Dec-2021, the patient developed a non-serious feeling sick (malaise) and fever (pyrexia) (unknown latency) following the administration of INFLUENZA VACCINE and COVID-19 VACCINE MODERNA.  On 03-DEC-2021 the patient developed a non-serious event feeling sick (malaise) and fever (pyrexia) 3 years 8 months 11 days following the first dose intake and (unknown latency) following the last dose intake of DUPILUMAB.  It was reported " Patient called stated he got Corona virus disease (COVID-19) Covid booster (Moderna) and Flu vaccine about one week ago and has been feeling sick and has fever ever since. Patient stated he has similar issues after second Corona virus disease (COVID-19) Covid vaccine".  DUPILUMAB (DUPIXENT) was continued.  It was not reported if the patient received a corrective treatment for the events.  At time of reporting, the outcome was reported as unknown.  There will be no information available on the batch number for this case.
Sex: M
Vaccine: FLUX
Symptoms: Malaise
Clinical narrative: he was sick; Initial information received on 11-Dec-2021 regarding an unsolicited valid Social Media non-serious case from a consumer/non-healthcare professional.  This case involves an unknown age male patient who was sick (illness) after receiving INFLUENZA VACCINE.  The patient's medical history, past medical treatment(s), vaccination(s), concomitant medication(s) and family history were not provided.   On an unknown date, the patient received a dose of suspect INFLUENZA VACCINE produced by unknown manufacturer (lot number not reported) via unknown route at an unknown administration site for prophylactic vaccination.  On an unknown date the patient developed a non-serious he was sick (illness) (unknown latency) following the administration of INFLUENZA VACCINE.  It was reported "We stopped getting flu shots over a decade ago. Every time my husband got one, he was sick within the same day. Interestingly we don't get the flu."  It was unknown if there were lab data/results available.  It was not reported if the patient received any corrective treatment for the event.  At time of reporting, the outcome was Unknown for the event.  There will be no information available on the lot number for this case.
Sex: U
Vaccine: FLUX
Symptoms: Illness
Clinical narrative: violently ill each time; Initial information was received on 12-Dec-2021 regarding an unsolicited valid non-serious case received from a consumer/non-health care professional patient (under reference number: US-SA-SAC20211216001093). This case involves adult patient of unknown gender who experienced violently ill each time (illness) when received vaccine INFLUENZA VACCINE.  The patient never had the flu.  The patient's past medical treatment, vaccination, concomitant medication and family history were not provided.  The patient had five flu vaccines 96, 97, 98, 99 & 11 and their (medical doctor) MD advised them to avoid all vaccines.  On an unknown date, the patient received a dose of suspect INFLUENZA VACCINE produced by unknown manufacturer (lot number and expiry date not reported) via an unknown route at an unknown administration site for prophylactic vaccination.  On an unknown date the patient developed a non-serious violently ill each time (illness) (unknown latency) following the administration of INFLUENZA VACCINE.  Laboratory details were not reported.  It was not reported if the patient received a corrective treatment for the event.  At the time of reporting, the outcome was unknown for the event (illness).  The reporter assessed the causal relationship for event (illness) with the INFLUENZA VACCINE as not reported.  There will be no information available on the batch number for this case.
Sex: U
Vaccine: COVID19, FLUX
Symptoms: Illness
Clinical narrative: has gotten sick; Initial information received on 11-Dec-2021 regarding an unsolicited valid Social Media serious case received from a consumer/non-healthcare professional under reference number US-SA-SAC20211217000130.  This case involves a patient of (unknown demographics) who experienced gotten sick (illness), after receiving vaccines INFLUENZA VACCINE and COVID-19 VACCINE.  The patient's medical history, medical treatment(s), vaccination(s) and family history were not provided.  No other concomitant vaccines were not provided.   On an unknown date, the patient received a dose of suspect INFLUENZA VACCINE produced by unknown manufacturer (lot number and expiry date not reported) via an unknown route at an unknown administration site for prophylactic vaccination.  On an unknown date, the patient received a dose of suspect COVID-19 VACCINE not produced by Sanofi Pasteur (lot number and expiry date not reported) via an unknown route at an unknown administration site for prophylactic vaccination.  On an unknown date, the patient developed a serious sick (illness) (unknown latency) following the administration of INFLUENZA VACCINE and (unknown latency) following the administration of COVID-19 VACCINE. The patient was hospitalized for this event.  It was unknown if the patient experienced any additional symptoms/events.  It was unknown if there were lab data/results available.  It was not reported if the patient received a corrective treatment.  At time of reporting, outcome of the event was unknown.  There will be no information available on batch number for this case.; Sender's Comments: This case involves a patient of (unknown demographics) who experienced illness, after receiving vaccines INFLUENZA VACCINE produced by unknown manufacturer and COVID-19 VACCINE not produced by Sanofi Pasteur. The time to onset is not known for any event. However, patient's medical condition at time of vaccination, Lab data and other etiologies would be needed for complete assessment of the case. Based upon the reported information, the role of the individual vaccines cannot be assessed.
Sex: U
Vaccine: FLUX
Symptoms: Influenza
Clinical narrative: flu; Initial information was received on 12-Dec-2021 regarding an unsolicited valid non-serious case received from a consumer/non-health care professional (patient) via social media.  This case involves an unknown demographic patient (unknown age and unknown gender) who experienced flu (influenza) after receiving INFLUENZA VACCINE.  The patient's medical history, past medical treatment(s), vaccination(s), concomitant medications and family history were not provided.  On an unknown date, the patient received a dose of suspect INFLUENZA VACCINE produced by unknown manufacturer (lot number and expiry date not reported) via an unknown route at an unknown administration site for prophylactic vaccination.  On an unknown date, the patient developed a non-serious flu (influenza) (unknown latency) following the administration of INFLUENZA VACCINE.  Details of laboratory data not reported.  It was not reported if the patient received any corrective treatment for the event.  At time of reporting, the outcome was unknown for the event.  There will be no information available on the batch number for this case.
Age: 22.0
Sex: F
Vaccine: TDAP
Symptoms: Expired product administered, No adverse event
Clinical narrative: This case involves a 22-year-old female patient who vaccinated with a 0.5 mL (total, once) dose of expired DIPHTHERIA-2/TETANUS/5 AC PERTUSSIS VACCINE [ADACEL] (solution, lot C5687AA, expiry date 09-Dec-2021) via intramuscular route in the left arm on 10-Dec-2021 for prophylactic vaccination (expired product administered). Medical history, past medical treatment, past vaccination and family history were not provided. Concomitant medication reported no other vaccines. It was a case of actual medication error due to expired vaccine used (latency was on same day). It was reported "Caller states he gave an expired dose of ADACEL today and wants to know if there is an extended time it can be good past the expired date and what to look and what he should do?" At the time of report, no adverse event reported. This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holder's compliance with the requirements set out. The classification as a medical error is in no way intended, nor should it be interpreted or construed as an allegation or claim made by the marketing authorization holder that any third party has contributed to or is to be held liable for the occurrence of this medication error.
Sex: U
Vaccine: TDAP
Symptoms: No adverse event, Syringe issue
Clinical narrative: not sure if the patient got any or some of the vaccine; pushed the plunger and the medication leaked out; Initial information received on 13-Dec-2021 regarding an unsolicited valid non-serious case from a pharmacist via Agency (Reference number-00895629).  This case involves an unknown demographics patient who received vaccine DIPHTHERIA-2/TETANUS/5 AC PERTUSSIS VACCINE [ADACEL] pushed the plunger and the medication leaked out and not sure if the got any or some of the vaccine (underdose and syringe issue).  The patient past medical history, medical treatment, vaccination and family history were not provided.   On an unknown date, the patient received a dose of suspect DIPHTHERIA-2/TETANUS/5 AC PERTUSSIS VACCINE (batch number and expiry date: not reported) via unknown route in unknown administration site for prophylactic vaccination.  It was actual medication error case due to underdose and syringe issue (latency same day).  It was reported "when she was giving an Adacel injection and when she was ready and the needle was attached and "good to go" she pushed the plunger and the medication leaked out and she is not sure if the patient got any or some of the vaccine and she would like to know if she is supposed to readminister it.she asked what information was needed and then she states that she was just filling in today and that she won't be working if follow up is needed but other pharmacists would be there."  It was not reported if the patient received a corrective treatment for the events.  At the time of report no adverse event was reported.  There will be no information available on the batch number for this case.
Age: 75.0
Sex: F
Vaccine: FLU4
Symptoms: Extra dose administered
Clinical narrative: patient received two doses of the FLUZONE HIGH DOSE QUADRIVALENT, with no reported adverse event; Initial information regarding an unsolicited valid non-serious case was received from other health care professional via Agency (Reference number- 00895738) and transmitted to Sanofi on 13-Dec-2021.  This case involves a 75-year-old female patient who received a 0.7 mL dose of INFLUENZA QUADRIVAL A-B HIGH DOSE HV VACCINE [FLUZONE HIGH-DOSE QUADRIVALENT] on 19-Oct-2021 (route, administration site, batch number and expiry date not reported) and again received a 0.7 mL (once) dose of the same vaccine (lot UJ733AB, expiry date 30-Jun-2022) via intramuscular route in the left deltoid on 13-Dec-2021 for prophylactic vaccination (extra dose administered).  Medical history, past medical treatment, past vaccination and family history were not provided.  No other vaccines was reported.  It was a case of actual medication error due to extra dose administered (latency was on same day with last dose).  It was reported "Medical Assistant is calling to report that a patient received two doses of the FLUZONE HIGH DOSE QUADRIVALENT. The first dose was given on 19Oct2021 and the second dose was given today. Caller is wanting to know what to do."  At the time of report, no adverse event reported.  This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holder's compliance with the requirements set out in the Directive 2001/83/EC and Module VI of the Good Pharmacovigilance Practices. The classification as a medical error is in no way intended, nor should it be interpreted or construed as an allegation or claim made by the marketing authorization holder that any third party has contributed to or is to be held liable for the occurrence of this medication error.
Age: 28.0
Sex: F
Vaccine: COVID19
Symptoms: Blindness, Chills, Cold sweat, Fall, Mobility decreased
Clinical narrative: Chills, cold sweats, syncopal episode resulting in fall, unable to see when experiencing syncopal episode, extremely painful left arm, unable to move arm secondary to 10/10 pain and stiffness. Vasovegal episode.
Age: 28.0
Sex: F
Vaccine: COVID19
Symptoms: Musculoskeletal stiffness, Pain in extremity, Presyncope, Syncope
Clinical narrative: Chills, cold sweats, syncopal episode resulting in fall, unable to see when experiencing syncopal episode, extremely painful left arm, unable to move arm secondary to 10/10 pain and stiffness. Vasovegal episode.
Age: 63.0
Sex: F
Vaccine: COVID19
Symptoms: Burning sensation, Condition aggravated, Fatigue, Fungal infection, Headache
Clinical narrative: Symptoms of UTI  and/or yeast infection came back! All of a sudden after spending a day in bed with fever, fatigue, muscle aches, mild headache and nausea. These symptoms were not unexpected or concerning but the burning sensation of a UTI or some other sort of genitourinary problem was strong and shocking. I know these reactions are considered rare so I thought I should add my experience to the reporting. I am currently attempting to self-treat with cranberry, vitamin C, and probiotics (topically-used yogurt). If the symptoms don't clear up in a day or two I will contact my physician.
Age: 63.0
Sex: F
Vaccine: COVID19
Symptoms: Myalgia, Nausea, Pyrexia, Urinary tract disorder, Urinary tract infection
Clinical narrative: Symptoms of UTI  and/or yeast infection came back! All of a sudden after spending a day in bed with fever, fatigue, muscle aches, mild headache and nausea. These symptoms were not unexpected or concerning but the burning sensation of a UTI or some other sort of genitourinary problem was strong and shocking. I know these reactions are considered rare so I thought I should add my experience to the reporting. I am currently attempting to self-treat with cranberry, vitamin C, and probiotics (topically-used yogurt). If the symptoms don't clear up in a day or two I will contact my physician.
Age: 64.0
Sex: F
Vaccine: COVID19
Symptoms: Injection site erythema, Injection site pruritus, Injection site reaction, Injection site warmth
Clinical narrative: At the injection site it pulsed for an hr or so. Now it itches  is hot and red spot is growing to cover my upper arm.
Age: 36.0
Sex: F
Vaccine: COVID19
Symptoms: Abdominal pain upper, Menstruation delayed
Clinical narrative: Never missed a period and period late by approx 10 days. Ruled out pregnancy. Stomach cramping from period that I haven?t experienced since I first started getting periods
Age: 45.0
Sex: F
Vaccine: COVID19
Symptoms: Anaphylactic shock, Arrhythmia, Echocardiogram, Electrocardiogram ambulatory, Inappropriate schedule of product administration
Clinical narrative: Anaphylatic shock 5 minutes after receiving the second dose of Moderna, had to be taken to the hospital by ambulance where paramedics administered  antihistamine and steroids intravenous. Spent the rest of the day with medications at E R, was released with medication. Three days after  sympthoms of tachycardia and heavy cardiac arrhytmia started, at this time I´m under  medication to control this matter.
Age: 45.0
Sex: F
Vaccine: COVID19
Symptoms: Tachycardia
Clinical narrative: Anaphylatic shock 5 minutes after receiving the second dose of Moderna, had to be taken to the hospital by ambulance where paramedics administered  antihistamine and steroids intravenous. Spent the rest of the day with medications at E R, was released with medication. Three days after  sympthoms of tachycardia and heavy cardiac arrhytmia started, at this time I´m under  medication to control this matter.
Age: 36.0
Sex: F
Vaccine: COVID19
Symptoms: Axillary pain, Chills, Dizziness, Fatigue, Injection site erythema
Clinical narrative: 10 minutes after dose I felt lightheaded and shaky. This feeling continued for a few hours after dose. That night I started with body aches, nausea, and chills. Overnight I had a fever of 100.5 F. Body aches, nausea, and chills continued for 36 hours. I also felt very fatigued. Starting on day 2 I had pain in my armpit in injection and "Covid arm". Redness and swelling around injection site.
Age: 36.0
Sex: F
Vaccine: COVID19
Symptoms: Injection site swelling, Nausea, Pain, Pyrexia, Tremor
Clinical narrative: 10 minutes after dose I felt lightheaded and shaky. This feeling continued for a few hours after dose. That night I started with body aches, nausea, and chills. Overnight I had a fever of 100.5 F. Body aches, nausea, and chills continued for 36 hours. I also felt very fatigued. Starting on day 2 I had pain in my armpit in injection and "Covid arm". Redness and swelling around injection site.
Age: 36.0
Sex: F
Vaccine: COVID19
Symptoms: Vaccination site reaction
Clinical narrative: 10 minutes after dose I felt lightheaded and shaky. This feeling continued for a few hours after dose. That night I started with body aches, nausea, and chills. Overnight I had a fever of 100.5 F. Body aches, nausea, and chills continued for 36 hours. I also felt very fatigued. Starting on day 2 I had pain in my armpit in injection and "Covid arm". Redness and swelling around injection site.
Age: 43.0
Sex: F
Vaccine: COVID19
Symptoms: Asthenia, Cellulitis, Dyspnoea, Flushing, Induration
Clinical narrative: Generalized flushed skin with tingling, slight feeling of swelling in hands and feet. Was held for extended watch time for about an hour. R arm turned into large cellulitis with hard lump for 4 days, day 4-10 body/muscle was extremely weak, achy, shortness of breath, no energy and lethargic. Also acquired restless leg syndrome and cramping.
Age: 43.0
Sex: F
Vaccine: COVID19
Symptoms: Lethargy, Mass, Muscle spasms, Muscular weakness, Pain
Clinical narrative: Generalized flushed skin with tingling, slight feeling of swelling in hands and feet. Was held for extended watch time for about an hour. R arm turned into large cellulitis with hard lump for 4 days, day 4-10 body/muscle was extremely weak, achy, shortness of breath, no energy and lethargic. Also acquired restless leg syndrome and cramping.
Age: 43.0
Sex: F
Vaccine: COVID19
Symptoms: Paraesthesia, Peripheral swelling, Restless legs syndrome
Clinical narrative: Generalized flushed skin with tingling, slight feeling of swelling in hands and feet. Was held for extended watch time for about an hour. R arm turned into large cellulitis with hard lump for 4 days, day 4-10 body/muscle was extremely weak, achy, shortness of breath, no energy and lethargic. Also acquired restless leg syndrome and cramping.
Age: 50.0
Sex: F
Vaccine: COVID19
Symptoms: Arrhythmia, Dizziness, Dyspnoea, Electrocardiogram, Erythema
Clinical narrative: Before having my 2nd shot on the 17/12/21, I advised the nurse that after my first shot my heart started a little weird arythmia after 5 minutes of receiving the vaccine, that one week after the vaccine I had to stop exercising as my heart was jumping all over the place.   She advised I should wait a few minutes before going out to the waiting room  to see how I was.  Within 1 minute of receiving the vaccine, I felt my heart racing.  I started to feel light headed and was told to lie down by the nurse.  My heart continued to race, the nurse checked my blood pressure 3 times.  I started getting tingling in my legs and arms and within 10 minutes quite sore up my left arm.  My head was so light headed, I thought I would never be able to stand up again I felt so bad.  The ambulance was called.  I was taken into the ambulance where they did a thorough ECG.  Everything was fine after an hour.  I couldnt drive.  The rest of the day was uneasy breathing.  The next day had aches and pains.  Took panadol.. Little palpatations have begun daily since Saturday.  My arm is still sore, red, swollen and itchy.  Very different to my first vaccine.  Have done all the icing regularly etc. But feels odd.