chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 83.0
Sex: F
Vaccine: COVID19
Symptoms: Back pain, Fatigue, Mobility decreased, Pain in extremity, Toothache
Clinical narrative: She could not move for many hours/She could see the phone but could not crawl to get to it/She could not reach for water for 18 hours until her neighbor walked in; She had extreme pain (Excruciating) in the lower back/The pain was so bad that she was crying; She had extreme pain (Excruciating) in the teeth/The pain was so bad that she was crying; Lower Leg pain; Fatigue; This spontaneous case was reported by a consumer and describes the occurrence of MOBILITY DECREASED (She could not move for many hours/She could see the phone but could not crawl to get to it/She could not reach for water for 18 hours until her neighbor walked in), BACK PAIN (She had extreme pain (Excruciating) in the lower back/The pain was so bad that she was crying), TOOTHACHE (She had extreme pain (Excruciating) in the teeth/The pain was so bad that she was crying), PAIN IN EXTREMITY (Lower Leg pain) and FATIGUE (Fatigue) in an 84-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 939903, 001A21A and 015M20A) for COVID-19 vaccination. Concurrent medical conditions included Scoliosis, Pulmonary fibrosis and Blood pressure high.On 05-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form.On 05-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form.On 10-Nov-2021 at 1:00 PM, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 10-Nov-2021, the patient experienced BACK PAIN (She had extreme pain (Excruciating) in the lower back/The pain was so bad that she was crying), TOOTHACHE (She had extreme pain (Excruciating) in the teeth/The pain was so bad that she was crying), PAIN IN EXTREMITY (Lower Leg pain) and FATIGUE (Fatigue). On 10-Nov-2021 at 9:00 PM, the patient experienced MOBILITY DECREASED (She could not move for many hours/She could see the phone but could not crawl to get to it/She could not reach for water for 18 hours until her neighbor walked in). At the time of the report, MOBILITY DECREASED (She could not move for many hours/She could see the phone but could not crawl to get to it/She could not reach for water for 18 hours until her neighbor walked in), BACK PAIN (She had extreme pain (Excruciating) in the lower back/The pain was so bad that she was crying), TOOTHACHE (She had extreme pain (Excruciating) in the teeth/The pain was so bad that she was crying), PAIN IN EXTREMITY (Lower Leg pain) and FATIGUE (Fatigue) outcome was unknown. Reporter states that patient doesn't remember the medication's name which patient was taking.No treatment information was provided.This case was linked to MOD-2021-385914 (Patient Link).
Age: 82.0
Sex: F
Vaccine: COVID19
Symptoms: Rash erythematous
Clinical narrative: I got a rash on my neck & back The rash was red, & had red bumps; This spontaneous case was reported by a consumer and describes the occurrence of RASH ERYTHEMATOUS (I got a rash on my neck & back The rash was red, & had red bumps) in an 82-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 030L21A) for COVID-19 vaccination.     Concurrent medical conditions included Allergy to antibiotic (PCN), Allergy to antibiotic (Tetracycline), Drug allergy (Sulfa), Drug allergy (Codeine), Drug allergy (Celecoxib) and Latex allergy.    On 25-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 04-Feb-2021, the patient experienced RASH ERYTHEMATOUS (I got a rash on my neck & back The rash was red, & had red bumps). At the time of the report, RASH ERYTHEMATOUS (I got a rash on my neck & back The rash was red, & had red bumps) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       patient stated that rash is getting a little better. But she keep having flare ups. No relevant concomitant product were reported No treatment medication was provided   This case was linked to MOD-2021-385964 (Patient Link).
Sex: F
Vaccine: COVID19
Symptoms: Erythema, Induration, Swelling, Vaccination site discolouration
Clinical narrative: arm turned into a pinkish color and had a light pink and black ring around the vaccination site (right upper arm). Swelling inches below the vaccination and down to the elbow; Hardness inches below the vaccination and down to the elbow.; redness 2 inches below the vaccination and down to the elbow; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE DISCOLOURATION (arm turned into a pinkish color and had a light pink and black ring around the vaccination site (right upper arm).), VACCINATION SITE SWELLING (Swelling inches below the vaccination and down to the elbow), VACCINATION SITE INDURATION (Hardness inches below the vaccination and down to the elbow.) and VACCINATION SITE ERYTHEMA (redness 2 inches below the vaccination and down to the elbow) 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 08-Nov-2021, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 08-Nov-2021, the patient experienced VACCINATION SITE DISCOLOURATION (arm turned into a pinkish color and had a light pink and black ring around the vaccination site (right upper arm).), VACCINATION SITE SWELLING (Swelling inches below the vaccination and down to the elbow), VACCINATION SITE INDURATION (Hardness inches below the vaccination and down to the elbow.) and VACCINATION SITE ERYTHEMA (redness 2 inches below the vaccination and down to the elbow). At the time of the report, VACCINATION SITE DISCOLOURATION (arm turned into a pinkish color and had a light pink and black ring around the vaccination site (right upper arm).), VACCINATION SITE SWELLING (Swelling inches below the vaccination and down to the elbow), VACCINATION SITE INDURATION (Hardness inches below the vaccination and down to the elbow.) and VACCINATION SITE ERYTHEMA (redness 2 inches below the vaccination and down to the elbow) outcome was unknown. Concomitant medication details were not provided.Treatment details were not provided.
Sex: F
Vaccine: COVID19
Symptoms: Cough, Oropharyngeal pain, Rhinitis allergic, Throat irritation
Clinical narrative: Nasal allergy/nasal rhinitis/She has had rhinitis since she was 3 years old, and she had these symptoms with the first dose; Coughing a little bit/if she drinks water she starts coughing; Her throat feels irritated from time to time/it's slightly irritated; Throat feels irritated from time to time, it's not very sore; This spontaneous case was reported by a consumer and describes the occurrence of RHINITIS ALLERGIC (Nasal allergy/nasal rhinitis/She has had rhinitis since she was 3 years old, and she had these symptoms with the first dose), COUGH (Coughing a little bit/if she drinks water she starts coughing), THROAT IRRITATION (Her throat feels irritated from time to time/it's slightly irritated) and OROPHARYNGEAL PAIN (Throat feels irritated from time to time, it's not very sore) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 012A21A) for COVID-19 vaccination. Concurrent medical conditions included Rhinitis (has had rhinitis since she was 3 years old) and Nasal allergy. On 26-Feb-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 RHINITIS ALLERGIC (Nasal allergy/nasal rhinitis/She has had rhinitis since she was 3 years old, and she had these symptoms with the first dose), COUGH (Coughing a little bit/if she drinks water she starts coughing), THROAT IRRITATION (Her throat feels irritated from time to time/it's slightly irritated) and OROPHARYNGEAL PAIN (Throat feels irritated from time to time, it's not very sore). At the time of the report, RHINITIS ALLERGIC (Nasal allergy/nasal rhinitis/She has had rhinitis since she was 3 years old, and she had these symptoms with the first dose), COUGH (Coughing a little bit/if she drinks water she starts coughing), THROAT IRRITATION (Her throat feels irritated from time to time/it's slightly irritated) and OROPHARYNGEAL PAIN (Throat feels irritated from time to time, it's not very sore) outcome was unknown. mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) dosing remained unchanged. Concomitant medication list was not provided. Treatment information was not provided. This case was linked to MOD-2021-385974 (Patient Link).
Age: 72.0
Sex: F
Vaccine: COVID19
Symptoms: Fatigue
Clinical narrative: Really tired after second shot; This spontaneous case was reported by a consumer and describes the occurrence of FATIGUE (Really tired after second shot) in a 72-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 001B21A and 006M20A) for COVID-19 vaccination.     No Medical History information was reported.   On 12-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 12-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 13-Mar-2021,  after starting mRNA-1273 (Moderna COVID-19 Vaccine), the patient experienced FATIGUE (Really tired after second shot). At the time of the report, FATIGUE (Really tired after second shot) outcome was unknown.            No Concomitant medication was reported.     No treatment medications were reported.   This case was linked to MOD-2021-385830 (Patient Link).
Sex: U
Vaccine: COVID19
Symptoms: Vaccination site erythema, Vaccination site pruritus
Clinical narrative: arm itching really bad after booster dose; arm is a little red; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE PRURITUS (arm itching really bad after booster dose) and VACCINATION SITE ERYTHEMA (arm is a little red) in a patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On an unknown date, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced VACCINATION SITE PRURITUS (arm itching really bad after booster dose) and VACCINATION SITE ERYTHEMA (arm is a little red). At the time of the report, VACCINATION SITE PRURITUS (arm itching really bad after booster dose) and VACCINATION SITE ERYTHEMA (arm is a little red) outcome was unknown.            No concomitant medications were reported. No treatment information were reported.  Company comment: This case concerns a patient of an unknown age and gender with no relevant medical history, who experienced the expected events of Vaccination Site Pruritus and Vaccination Site Erythema. The event occurred on an unknown date after receiving the third dose of mRNA-1273 Vaccine. The rechallenge was not applicable since only information about the third dose was disclosed. The events are consistent with the current understanding of the mechanism of action of the vaccine. The benefit-risk relationship of mRNA-1273 Vaccine is not affected by this report. Sender's Comments: This case concerns a patient of an unknown age and gender with no relevant medical history, who experienced the expected events of Vaccination Site Pruritus and Vaccination Site Erythema. The event occurred on an unknown date after receiving the third dose of mRNA-1273 Vaccine. The rechallenge was not applicable since only information about the third dose was disclosed. The events are consistent with the current understanding of the mechanism of action of the vaccine. The benefit-risk relationship of mRNA-1273 Vaccine is not affected by this report.
Age: 54.0
Sex: F
Vaccine: COVID19
Symptoms: Bradykinesia, Chills, Disturbance in attention, Feeling abnormal, Headache
Clinical narrative: slow processing; body ache; can't focus all day; still not feel by myself; I sleep the next day, same flue symptoms; chills; headache; Myalgia; This spontaneous case was reported by a consumer and describes the occurrence of INFLUENZA LIKE ILLNESS (I sleep the next day, same flue symptoms), DISTURBANCE IN ATTENTION (can't focus all day), FEELING ABNORMAL (still not feel by myself), BRADYKINESIA (slow processing) and PAIN (body ache) in a 65-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 0021321A and 011M203) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below. No Medical History information was reported.On 15-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form.On 15-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 15-Mar-2021, the patient experienced INFLUENZA LIKE ILLNESS (I sleep the next day, same flue symptoms), CHILLS (chills), HEADACHE (headache) and MYALGIA (Myalgia). On 17-Mar-2021, the patient experienced DISTURBANCE IN ATTENTION (can't focus all day) and FEELING ABNORMAL (still not feel by myself). On an unknown date, the patient experienced BRADYKINESIA (slow processing) and PAIN (body ache). The patient was treated with IBUPROFEN for No adverse event, at a dose of 200 mg. At the time of the report, INFLUENZA LIKE ILLNESS (I sleep the next day, same flue symptoms), HEADACHE (headache) and MYALGIA (Myalgia) was resolving, DISTURBANCE IN ATTENTION (can't focus all day), FEELING ABNORMAL (still not feel by myself), BRADYKINESIA (slow processing) and PAIN (body ache) outcome was unknown and CHILLS (chills) had not resolved. No concomitant and treatment medication were reported. The patient sleep the next day, same flu symptoms, chills, headache, body ache. On Tuesday had the chills but, started to get better. On Wednesday mind head could not focus all day, never experience that. On Wednesday's night, Thursday and today, forgetting things could not  focus, slow processing, hard time to decision making. The patient work but, still not feel by myself. The patient said work part time on Wednesday and full time on Thursday and Friday, It was hard but, could not concentrate. This case was linked to MOD-2021-386023 (Patient Link).
Age: 54.0
Sex: F
Vaccine: COVID19
Symptoms: Influenza like illness, Myalgia, Pain
Clinical narrative: slow processing; body ache; can't focus all day; still not feel by myself; I sleep the next day, same flue symptoms; chills; headache; Myalgia; This spontaneous case was reported by a consumer and describes the occurrence of INFLUENZA LIKE ILLNESS (I sleep the next day, same flue symptoms), DISTURBANCE IN ATTENTION (can't focus all day), FEELING ABNORMAL (still not feel by myself), BRADYKINESIA (slow processing) and PAIN (body ache) in a 65-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 0021321A and 011M203) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below. No Medical History information was reported.On 15-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form.On 15-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 15-Mar-2021, the patient experienced INFLUENZA LIKE ILLNESS (I sleep the next day, same flue symptoms), CHILLS (chills), HEADACHE (headache) and MYALGIA (Myalgia). On 17-Mar-2021, the patient experienced DISTURBANCE IN ATTENTION (can't focus all day) and FEELING ABNORMAL (still not feel by myself). On an unknown date, the patient experienced BRADYKINESIA (slow processing) and PAIN (body ache). The patient was treated with IBUPROFEN for No adverse event, at a dose of 200 mg. At the time of the report, INFLUENZA LIKE ILLNESS (I sleep the next day, same flue symptoms), HEADACHE (headache) and MYALGIA (Myalgia) was resolving, DISTURBANCE IN ATTENTION (can't focus all day), FEELING ABNORMAL (still not feel by myself), BRADYKINESIA (slow processing) and PAIN (body ache) outcome was unknown and CHILLS (chills) had not resolved. No concomitant and treatment medication were reported. The patient sleep the next day, same flu symptoms, chills, headache, body ache. On Tuesday had the chills but, started to get better. On Wednesday mind head could not focus all day, never experience that. On Wednesday's night, Thursday and today, forgetting things could not  focus, slow processing, hard time to decision making. The patient work but, still not feel by myself. The patient said work part time on Wednesday and full time on Thursday and Friday, It was hard but, could not concentrate. This case was linked to MOD-2021-386023 (Patient Link).
Age: 43.0
Sex: F
Vaccine: COVID19
Symptoms: Injection site pain
Clinical narrative: sore arm; This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (sore arm) in a 43-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 052E21A) for COVID-19 vaccination.     No Medical History information was reported.    On 11-Aug-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced PAIN IN EXTREMITY (sore arm). At the time of the report, PAIN IN EXTREMITY (sore arm) outcome was unknown.        mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosing remained unchanged.       No concomitant medication reported. No Treatment Medication reported.   This case was linked to MOD-2021-386057, MOD-2021-385745 (Patient Link).
Age: 73.0
Sex: F
Vaccine: COVID19
Symptoms: Vaccination site pain
Clinical narrative: sore left injection site arm after fist dose of Moderna Covid-19 vaccine; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE PAIN (sore left injection site arm after fist dose of Moderna Covid-19 vaccine) in a 73-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 031821A) for COVID-19 vaccination.  No Medical History information was reported. On 20-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced VACCINATION SITE PAIN (sore left injection site arm after fist dose of Moderna Covid-19 vaccine). At the time of the report, VACCINATION SITE PAIN (sore left injection site arm after fist dose of Moderna Covid-19 vaccine) outcome was unknown. The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.Treatment medication was not provided.Concomitant medication was not provided. This case was linked to MOD-2021-386043 (Patient Link). Most recent FOLLOW-UP information incorporated above includes: On 15-Nov-2021: Significant follow up appended-HCP details added, patient contact info added
Age: 67.0
Sex: F
Vaccine: COVID19
Symptoms: Arthritis, Carpal tunnel syndrome, Electronystagmogram, Heart rate increased, Vaccination site rash
Clinical narrative: increased my heart rate; arthritis; ENG showed carpal tunnel; I got a rash all over my arm from my elbow up same arm of injection; This spontaneous case was reported by a consumer and describes the occurrence of HEART RATE INCREASED (increased my heart rate), ARTHRITIS (arthritis), CARPAL TUNNEL SYNDROME (ENG showed carpal tunnel) and VACCINATION SITE RASH (I got a rash all over my arm from my elbow up same arm of injection) in a 67-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 047A21A) for COVID-19 vaccination. he patient's past medical history included Radioactive iodine therapy (years ago I had to have radioactive iodine for goiter).Concurrent medical conditions included Thyroid disorder, Penicillin allergy, Drug allergy and Latex allergy.Concomitant products included LEVOTHYROXINE SODIUM (SYNTHROID), ATENOLOL and LISINOPRIL for an unknown indication. On 22-Mar-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced HEART RATE INCREASED (increased my heart rate), ARTHRITIS (arthritis), CARPAL TUNNEL SYNDROME (ENG showed carpal tunnel) and VACCINATION SITE RASH (I got a rash all over my arm from my elbow up same arm of injection). At the time of the report, HEART RATE INCREASED (increased my heart rate), ARTHRITIS (arthritis) and CARPAL TUNNEL SYNDROME (ENG showed carpal tunnel) outcome was unknown and VACCINATION SITE RASH (I got a rash all over my arm from my elbow up same arm of injection) had resolved. DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available):On an unknown date, Electronystagmogram: carpal tunnel (abnormal) ENG showed carpal tunnel.On unknown date patient went for X-ray for right hand.After receiving two injections, patient can not keep thyroid level normal.No treatment information were reported by the reporter company comment included,This case concerns a 67 year-old, female patient with a medical history of thyroid disorder, who experienced the non serious unexpected AESI of Arthritis. The event occurred after the second dose of mRNA-1273 vaccine, exact date not provided. The rechallenge was not applicable as the event was reported exclusively after the second dose. The medical history, of thyroid disorder remains as confounder. The benefit-risk relationship of mRNA-1273 vaccine is not affected by this report.This case was linked to MOD-2021-386036 (Patient Link).Sender's Comments: This case concerns a 67 year-old, female patient with a medical history of thyroid disorder, who experienced the non serious unexpected AESI of Arthritis. The event occurred after the second dose of mRNA-1273 vaccine, exact date not provided. The rechallenge was not applicable as the event was reported exclusively after the second dose. The medical history, of thyroid disorder remains as confounder. The benefit-risk relationship of mRNA-1273 vaccine is not affected by this report.
Age: 76.0
Sex: M
Vaccine: COVID19
Symptoms: Vaccination site pruritus
Clinical narrative: have been itching a bit/itching a lot; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE PRURITUS (have been itching a bit/itching a lot) in a 77-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 0651214, 036a21a and 031120a) for COVID-19 vaccination. Concurrent medical conditions included Diabetes, Diarrhea, Blood pressure abnormal, Prostatic disorder, Gout, Acid reflux (esophageal) and Memory disturbance. Concomitant products included POTASSIUM for an unknown indication. On 10-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 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 10-Nov-2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 10-Nov-2021, the patient experienced VACCINATION SITE PRURITUS (have been itching a bit/itching a lot). The patient was treated with HYDROCORTISONE for Itching, at an unspecified dose and frequency. At the time of the report, VACCINATION SITE PRURITUS (have been itching a bit/itching a lot) outcome was unknown.    Concomitant medication contains diabetes pills,diarrhea pills,blood pressure medication,pills for prostate,pills for stomach acid,pills for memory, diuretic. After getting their Booster dose on the 10 Nov2021 with lot number 0651214, on their arm, they have been itching a bit, and on the 12 Nov2021 they have been itching a lot. They stated that they treated their symptoms with hydrocortisone.
Age: 54.0
Sex: M
Vaccine: COVID19
Symptoms: Pyrexia, Vaccination site mass
Clinical narrative: Knot at the site of injection (about 4 knots down her arm); Low grade fever; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE MASS (Knot at the site of injection (about 4 knots down her arm)) and PYREXIA (Low grade fever) in a 55-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 030L20A and 039K20A) for COVID-19 vaccination. Concurrent medical conditions included Gout and Osteoarthritis.On 30-Dec-2020, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form.On 27-Jan-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On an unknown date, the patient experienced VACCINATION SITE MASS (Knot at the site of injection (about 4 knots down her arm)) and PYREXIA (Low grade fever). At the time of the report, VACCINATION SITE MASS (Knot at the site of injection (about 4 knots down her arm)) and PYREXIA (Low grade fever) outcome was unknown. No treatment medications reported specifically for the particular event.The patient had no side effects with first vaccination. It was reported that She has taken her prescribed medication Indomethacin; she has gout and osteoarthritis.This case was linked to MOD-2021-386111 (Patient Link).
Age: 65.0
Sex: F
Vaccine: COVID19
Symptoms: Diarrhoea, Fatigue, Nausea, Tinnitus, Vomiting
Clinical narrative: I had ringing in both ears, like my head's in a bowl & there's noise in it, like crickets or white noise; diarrhea; tired; nausea; vomiting; This spontaneous case was reported by a consumer and describes the occurrence of TINNITUS (I had ringing in both ears, like my head's in a bowl & there's noise in it, like crickets or white noise), DIARRHOEA (diarrhea), FATIGUE (tired), NAUSEA (nausea) and VOMITING (vomiting) in a 65-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 047C21A, 029A21A and 010A21A) for COVID-19 vaccination.     No Medical History information was reported.   On 24-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 29-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 02-Nov-2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 03-Nov-2021, the patient experienced DIARRHOEA (diarrhea), FATIGUE (tired), NAUSEA (nausea) and VOMITING (vomiting). On 07-Nov-2021, the patient experienced TINNITUS (I had ringing in both ears, like my head's in a bowl & there's noise in it, like crickets or white noise). In November 2021, DIARRHOEA (diarrhea), FATIGUE (tired), NAUSEA (nausea) and VOMITING (vomiting) had resolved. At the time of the report, TINNITUS (I had ringing in both ears, like my head's in a bowl & there's noise in it, like crickets or white noise) had not resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No relevant concomitant medications were reported.  On 03-Nov-2021, patient felt tired, had nausea, vomiting, diarrhea for 1 week - mostly in the mornings.  On 12-Nov-2021, Stated that the ringing in ears was worse today.  Treatment medication was not provided by the reporter.   This case was linked to MOD-2021-386085, MOD-2021-386019 (Patient Link).
Sex: U
Vaccine: COVID19
Symptoms: Inappropriate schedule of product administration
Clinical narrative: second dose given more than 6 months after the first/ the second dose was more than 42 days after the first; Based on the current case data, this case has been classified as invalid. This spontaneous case was reported by a physician and describes the occurrence of INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (second dose given more than 6 months after the first/ the second dose was more than 42 days after the first) in a  patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History 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 INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (second dose given more than 6 months after the first/ the second dose was more than 42 days after the first). At the time of the report, INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (second dose given more than 6 months after the first/ the second dose was more than 42 days after the first) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No Concomitant medication was reported.     No treatment medications were reported.   Reporter did not allow further contact
Age: 42.0
Sex: F
Vaccine: COVID19
Symptoms: Seizure
Clinical narrative: seizures; This spontaneous case was reported by a consumer and describes the occurrence of SEIZURE (seizures) in a 42-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 032B21A and 026A21A) for COVID-19 vaccination.     No Medical History information was reported.   On 06-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 04-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 SEIZURE (seizures) (seriousness criterion medically significant). At the time of the report, SEIZURE (seizures) had not resolved.            No concomitant medication were reported. No treatment medication were reported.  Company Comment: This case concerns a 42-year-old, female patient, with no known medical history, who experienced the serious, unexpected event of seizure. The event occurred two weeks after first dose of mRNA 1273 vaccine. The patient said she had been having seizures ever since it started after first dose, she did not reveal any treatment medication given. The rechallenge is not applicable as event is still ongoing. The benefit-risk relationship of mRNA 1273 vaccine is not affected by this report.   This case was linked to MOD-2021-361648 (Patient Link).; Sender's Comments: This case concerns a 42-year-old, female patient, with no known medical history, who experienced the serious, unexpected event of seizure. The event occurred two weeks after first dose of mRNA 1273 vaccine. The patient said she had been having seizures ever since it started after first dose, she did not reveal any treatment medication given. The rechallenge is not applicable as event is still ongoing. The benefit-risk relationship of mRNA 1273 vaccine is not affected by this report.
Sex: F
Vaccine: COVID19
Symptoms: Adverse drug reaction, Illness
Clinical narrative: all the side effects I'm having from the shot; I have been sick over 30 days; This spontaneous case was reported by a consumer and describes the occurrence of ADVERSE DRUG REACTION (all the side effects I'm having from the shot) and ILLNESS (I have been sick over 30 days) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On an unknown date, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 05-May-2021, the patient experienced ADVERSE DRUG REACTION (all the side effects I'm having from the shot) and ILLNESS (I have been sick over 30 days). At the time of the report, ADVERSE DRUG REACTION (all the side effects I'm having from the shot) and ILLNESS (I have been sick over 30 days) had not resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No concomitant medications were reported.  No treatment medications were reported.
Age: 66.0
Sex: F
Vaccine: COVID19
Symptoms: Device connection issue, Underdose
Clinical narrative: Booster immunization, and the fact that all the liquid leaked out of her arm after it was given, the vaccine leaked out on my arm, I think I didn't get the booster shot at all; Booster immunization, and the fact that all the liquid leaked out of her arm after it was given,cavity was full of fluid mixed with blood; This spontaneous case was reported by a consumer and describes the occurrence of UNDERDOSE (Booster immunization, and the fact that all the liquid leaked out of her arm after it was given, the vaccine leaked out on my arm, I think I didn't get the booster shot at all) and DEVICE CONNECTION ISSUE (Booster immunization, and the fact that all the liquid leaked out of her arm after it was given,cavity was full of fluid mixed with blood) in a 66-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 039F21A) for COVID-19 vaccination. No medical history was reported. Concomitant products included ATORVASTATIN and AMLODIPINE for an unknown indication. On 12-Nov-2021, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 12-Nov-2021, the patient experienced UNDERDOSE (Booster immunization, and the fact that all the liquid leaked out of her arm after it was given, the vaccine leaked out on my arm, I think I didn't get the booster shot at all) and DEVICE CONNECTION ISSUE (Booster immunization, and the fact that all the liquid leaked out of her arm after it was given,cavity was full of fluid mixed with blood). On 12-Nov-2021, UNDERDOSE (Booster immunization, and the fact that all the liquid leaked out of her arm after it was given, the vaccine leaked out on my arm, I think I didn't get the booster shot at all) and DEVICE CONNECTION ISSUE (Booster immunization, and the fact that all the liquid leaked out of her arm after it was given,cavity was full of fluid mixed with blood) had resolved. No Treatment Information were provided by the reporter.Most recent FOLLOW-UP information incorporated above includes:On 15-Nov-2021: Significant follow-up-Received contains Reporter Information, Patient demographics and dose details updated.
Sex: M
Vaccine: COVID19
Symptoms: Arthritis
Clinical narrative: Arthritis flared up in right and left hand after the 2nd dose; This spontaneous case was reported by a consumer and describes the occurrence of ARTHRITIS (Arthritis flared up in right and left hand after the 2nd dose) in a male patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 007BZIA and 022M20A) for COVID-19 vaccination. Concurrent medical conditions included Arthritis.On 25-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 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 an unknown date, the patient experienced ARTHRITIS (Arthritis flared up in right and left hand after the 2nd dose). At the time of the report, ARTHRITIS (Arthritis flared up in right and left hand after the 2nd dose) had not resolved. For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.Concomitant information was not provided.It was reported that patient's arthritis flared up right and left hand. Also sated that index finger and thumb of the patient had swollen a  little.Treatment information was not provided. This case was linked to MOD-2021-386282 (Patient Link). Sender's Comments: This case concerns a male patient of an unknown age, with a history of arthritis, who experienced the unexpected non-serious AESI of ARTHRITIS. The event occurred on an unknown date after the second dose mRNA-1273. The rechallenge was not applicable as the outcome of the event is unknown. The history of arthritis remains a confounder. The benefit-risk relationship of mRNA-1273 is not affected by this report.
Sex: U
Vaccine: COVID19
Symptoms: Vaccination complication
Clinical narrative: Side effects on the third Moderna booster; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION COMPLICATION (Side effects on the third Moderna booster) in a  patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. No Medical History information was reported.On an unknown date, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced VACCINATION COMPLICATION (Side effects on the third Moderna booster). At the time of the report, VACCINATION COMPLICATION (Side effects on the third Moderna booster) outcome was unknown.  No concomitant medications were reported.No treatment medications were reported.
Sex: F
Vaccine: COVID19
Symptoms: Fatigue
Clinical narrative: little tired; This spontaneous case was reported by a patient family member or friend and describes the occurrence of FATIGUE (little tired) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. No Medical History information was reported.On an unknown date, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced FATIGUE (little tired). At the time of the report, FATIGUE (little tired) outcome was unknown. Not Provided  The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown Route) was unknown. No concomitant and treatment information was reported by reporter.
Sex: F
Vaccine: COVID19
Symptoms: Thrombosis
Clinical narrative: blood clots; This spontaneous case was reported by a consumer and describes the occurrence of THROMBOSIS (blood clots) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 025G202A) for COVID-19 vaccination.     No Medical History information was reported.   On 04-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 03-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 THROMBOSIS (blood clots) (seriousness criterion medically significant). The patient was treated with WARFARIN SODIUM (COUMADIN) for Clot blood, at an unspecified dose and frequency. At the time of the report, THROMBOSIS (blood clots) outcome was unknown.            The concomitant medications were not reported.  Patient enquired if she can take the booster dose after having blood clot post second dose of moderna vaccine.  Company Comment: This case concerns a female patient, unknown age with no relevant medical history, who experienced the serious, unexpected, AESI event of Thrombosis. The event occurred  on unknown date after second dose of mRNA 1273 vaccine and had warfarin as treatment for blood clots. The rechallenge is not applicable as patient received treatment for the event. The benefit-risk relationship of mRNA 1273 vaccine is not affected by this report.; Sender's Comments: This case concerns a female patient, unknown age with no relevant medical history, who experienced the serious, unexpected, AESI event of Thrombosis. The event occurred  on unknown date after second dose of mRNA 1273 vaccine and had warfarin as treatment for blood clots. The rechallenge is not applicable as patient received treatment for the event. The benefit-risk relationship of mRNA 1273 vaccine is not affected by this report.
Sex: F
Vaccine: COVID19
Symptoms: Vaccination site rash
Clinical narrative: "half of a cantaloupe" size rash at injection site after vaccine; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE RASH ("half of a cantaloupe" size rash at injection site after vaccine) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. Concurrent medical conditions included Hypochondriacal personality.In March 2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form.In April 2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient experienced VACCINATION SITE RASH ("half of a cantaloupe" size rash at injection site after vaccine). At the time of the report, VACCINATION SITE RASH ("half of a cantaloupe" size rash at injection site after vaccine) outcome was unknown.    Concomitant medications were not reported.Treatment medications were not reported.
Sex: U
Vaccine: COVID19
Symptoms: Vaccination complication
Clinical narrative: Reaction; 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 VACCINATION COMPLICATION (Reaction) in a  patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On an unknown date, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced VACCINATION COMPLICATION (Reaction). At the time of the report, VACCINATION COMPLICATION (Reaction) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No concomitant medication details was reported. No treatment medication details was reported.
Age: 23.0
Sex: M
Vaccine: COVID19
Symptoms: Expired product administered
Clinical narrative: Second dose administered greater than 12 hours post puncture; This spontaneous case was reported by a nurse and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Second dose administered greater than 12 hours post puncture) in a 23-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 027C21A) for COVID-19 vaccination.  The patient's past medical history included Hypertension since an unknown date. Concurrent medical conditions included Morbid obesity.On 04-Oct-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 11-Nov-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 11-Nov-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (Second dose administered greater than 12 hours post puncture). On 11-Nov-2021, EXPIRED PRODUCT ADMINISTERED (Second dose administered greater than 12 hours post puncture) had resolved. For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments. No concomitant and treatment medications were provided by reporter.
Age: 48.0
Sex: F
Vaccine: COVID19
Symptoms: Expired product administered, Product temperature excursion issue
Clinical narrative: There was an excursion from the freezer; Expired vaccine used; This spontaneous case was reported by a nurse and describes the occurrence of PRODUCT TEMPERATURE EXCURSION ISSUE (There was an excursion from the freezer) and EXPIRED PRODUCT ADMINISTERED (Expired vaccine used) in a 49-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 939901) for COVID-19 vaccination. No Medical History information was reported. On 01-Nov-2021, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 01-Nov-2021, the patient experienced PRODUCT TEMPERATURE EXCURSION ISSUE (There was an excursion from the freezer) and EXPIRED PRODUCT ADMINISTERED (Expired vaccine used). On 01-Nov-2021, PRODUCT TEMPERATURE EXCURSION ISSUE (There was an excursion from the freezer) and EXPIRED PRODUCT ADMINISTERED (Expired vaccine used) had resolved. Not provided. For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments. Concomitant medications was not reported.Treatment medications was not reported.
Age: 78.0
Sex: M
Vaccine: COVID19
Symptoms: Expired product administered, Product temperature excursion issue
Clinical narrative: There was an excursion from the freezer; administered to 118 patients; This spontaneous case was reported by a nurse and describes the occurrence of PRODUCT TEMPERATURE EXCURSION ISSUE (There was an excursion from the freezer) and EXPIRED PRODUCT ADMINISTERED (administered to 118 patients) in a 78-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 939901) for COVID-19 vaccination. No Medical History information was reported.On 25-Oct-2021, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 25-Oct-2021, the patient experienced PRODUCT TEMPERATURE EXCURSION ISSUE (There was an excursion from the freezer) and EXPIRED PRODUCT ADMINISTERED (administered to 118 patients). On 25-Oct-2021, PRODUCT TEMPERATURE EXCURSION ISSUE (There was an excursion from the freezer) and EXPIRED PRODUCT ADMINISTERED (administered to 118 patients) had resolved. Not provided. For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments. Concomitant product use was not provided by the reporter.  No treatment information provided.
Sex: M
Vaccine: FLUR4
Symptoms: Extra dose administered, Medication error, No adverse event
Clinical narrative: patient received FLUBLOK on 24SEP2021/then again on 05NOV2021 with no reported adverse event; Initial information regarding an unsolicited valid non-serious case was received from other health professional via the Agency (Reference number- 00853841) and transmitted to Sanofi on 11-Nov-2021.  This case involves a 67 years old male patient who received INFLUENZA QUADRIVALENT RECOMBINANT VACCINE [FLUBLOK QIV] two times.  Past medical history, medical treatment(s), vaccination(s) and family history were not provided.  On 05-Nov-2021, the patient received a 0.5 mL dose of suspect INFLUENZA QUADRIVALENT RECOMBINANT VACCINE lot QFAA2154 expiry date 30-05-22 and on 24-Sep-2021 he also received a 0.5 mL dose of the same vaccine lot QFAA2108 expiry date 30-05-22 via intramuscular route in unknown administration site for prophylactic vaccination.  It was a case of an actual medication error due to extra dose administered.  It was reported "a patient received a FLUBLOK vaccine in their office. HCP staff later discovered that the patient had already received a FLUBLOK vaccine somewhere else. HCP states that it was an accidental discovery, when she contacted the patient, he was not aware that he had gotten the same vaccine twice. She states that the language spoke is not his first language, so that may have contributed to the mix-up."  No adverse events have been 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.