chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Sex: U
Vaccine: COVID19
Symptoms: Rash
Clinical narrative: reporting side effects of rash on back of neck and moving throughout my body; This spontaneous case was reported by a consumer (subsequently medically confirmed) and describes the occurrence of RASH (reporting side effects of rash on back of neck and moving throughout my body) 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 RASH (reporting side effects of rash on back of neck and moving throughout my body). At the time of the report, RASH (reporting side effects of rash on back of neck and moving throughout my body) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   Reporter reported that when she saw her HCP on 07-Dec-2021, HCP mentioned that she was the second patient he has seen presenting with these symptoms and received their Moderna vaccine within the past 10 days.  No relevant concomitant medications were reported. No treatment information was provided.   Reporter did not allow further contact
Age: 78.0
Sex: F
Vaccine: COVID19
Symptoms: Chills, Fatigue, Headache, Myalgia
Clinical narrative: heavy fatigue; chills; muscle pain; mild headaches; This spontaneous case was reported by a consumer and describes the occurrence of FATIGUE (heavy fatigue), CHILLS (chills), MYALGIA (muscle pain) and HEADACHE (mild headaches) in a 78-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 020f21a) for COVID-19 vaccination.     Previously administered products included for Product used for unknown indication: Pfizer COVID19 vaccine and Pfizer COVID19 vaccine. Past adverse reactions to the above products included No adverse event with Pfizer COVID19 vaccine and Pfizer COVID19 vaccine. Concurrent medical conditions included Atrial fibrillation. Concomitant products included APIXABAN (ELIQUIS) for Atrial fibrillation, VITAMINS NOS for an unknown indication.    On 03-Dec-2021, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 04-Dec-2021, the patient experienced FATIGUE (heavy fatigue), CHILLS (chills), MYALGIA (muscle pain) and HEADACHE (mild headaches). At the time of the report, FATIGUE (heavy fatigue), CHILLS (chills) and HEADACHE (mild headaches) had not resolved and MYALGIA (muscle pain) had resolved.            Treatment information was unknown
Age: 88.0
Sex: M
Vaccine: COVID19
Symptoms: Pyrexia, Vaccination site pain, Vaccination site rash, Vaccination site warmth
Clinical narrative: injection site warm to the touch; rash at the site; slight fever; tenderness at the site; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE WARMTH (injection site warm to the touch), VACCINATION SITE RASH (rash at the site), PYREXIA (slight fever) and VACCINATION SITE PAIN (tenderness at the site) in an 88-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     Previously administered products included for COVID-19 vaccination: Johnson&Johnson. Past adverse reactions to the above products included No adverse event with Johnson&Johnson.    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 WARMTH (injection site warm to the touch), VACCINATION SITE RASH (rash at the site), PYREXIA (slight fever) and VACCINATION SITE PAIN (tenderness at the site). At the time of the report, VACCINATION SITE WARMTH (injection site warm to the touch), VACCINATION SITE RASH (rash at the site), PYREXIA (slight fever) and VACCINATION SITE PAIN (tenderness at the site) outcome was unknown.            No concomitant medications were reported. No treatment medications were reported.
Age: 52.0
Sex: F
Vaccine: COVID19
Symptoms: Vaccination complication
Clinical narrative: symptoms were mild; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION COMPLICATION (symptoms were mild) in a 52-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 010A21A) for COVID-19 vaccination.     No medical history was provided by the reporter.  Concomitant products included LEVOTHYROXINE for an unknown indication.    On 12-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced VACCINATION COMPLICATION (symptoms were mild). At the time of the report, VACCINATION COMPLICATION (symptoms were mild) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No treatment medications were reported.   This case was linked to MOD-2021-406646, MOD-2021-406647 (Patient Link).
Age: 61.0
Sex: U
Vaccine: COVID19
Symptoms: Inappropriate schedule of product administration
Clinical narrative: First vaccine was and my 2nd was Moderna; This spontaneous case was reported by a pharmacist and describes the occurrence of INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (First vaccine was and my 2nd was Moderna) in a 61-year-old patient of an unknown gender who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     Previously administered products included for COVID-19 vaccination:  COVID-19 VACCINE (First dose). Past adverse reactions to the above products included No adverse event with  COVID-19 VACCINE.    On an unknown date, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (First vaccine was and my 2nd was Moderna). At the time of the report, INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (First vaccine was  and my 2nd was Moderna) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   The patient stated that it had been 6 months since last vaccine.  No concomitant medications were reported  No treatment information was provided
Age: 64.0
Sex: F
Vaccine: COVID19
Symptoms: Diarrhoea, Headache, Nausea
Clinical narrative: Diarrhea; Headache; Nausea; This spontaneous case was reported by a consumer and describes the occurrence of DIARRHOEA (Diarrhea), HEADACHE (Headache) and NAUSEA (Nausea) in a 64-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 037B21A) for COVID-19 vaccination.     The patient's past medical history included Knee surgery NOS in March 2021. Previously administered products included for Knee surgery NOS: Diclofenac (Took diclofenac after knee surgery in March.) in March 2021. Past adverse reactions to the above products included No adverse event with Diclofenac. Concomitant products included ATORVASTATIN and CARVEDILOL for an unknown indication.    On 08-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 08-Apr-2021, the patient experienced DIARRHOEA (Diarrhea), HEADACHE (Headache) and NAUSEA (Nausea). On 15-Apr-2021, DIARRHOEA (Diarrhea), HEADACHE (Headache) and NAUSEA (Nausea) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No treatment medication was provided.   This case was linked to MOD-2021-406564 (Patient Link).
Sex: F
Vaccine: COVID19
Symptoms: Fatigue, Pyrexia
Clinical narrative: Patient had a low grade fever after the booster dose; Patient had slight fatigue after the booster dose; This spontaneous case was reported by a consumer and describes the occurrence of PYREXIA (Patient had a low grade fever after the booster dose) and FATIGUE (Patient had slight fatigue after the booster dose) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.   In February 2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. 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, 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 PYREXIA (Patient had a low grade fever after the booster dose) and FATIGUE (Patient had slight fatigue after the booster dose). At the time of the report, PYREXIA (Patient had a low grade fever after the booster dose) and FATIGUE (Patient had slight fatigue after the booster dose) outcome was unknown.            No concomitant medications were reported.  It was reported that, the patient had a low grade fever and felt like they had slight fatigue after booster dose.  No treatment information was reported.   This case was linked to MOD-2021-406507 (Patient Link).   Reporter did not allow further contact
Age: 35.0
Sex: M
Vaccine: COVID19
Symptoms: Underdose
Clinical narrative: Half dose was administered; This spontaneous case was reported by a pharmacist and describes the occurrence of UNDERDOSE (Half dose was administered) in a 35-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 058H21A) for COVID-19 vaccination.     No Medical History information was reported.    On 07-Dec-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) .25 ml. On 07-Dec-2021, the patient experienced UNDERDOSE (Half dose was administered). On 07-Dec-2021, UNDERDOSE (Half dose was administered) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   Concomitant product use was not provided by the reporter. No treatment information was provided.
Sex: M
Vaccine: COVID19
Symptoms: Product administered to patient of inappropriate age
Clinical narrative: 15 year old received primary series of possibly Moderna COVID-19 vaccine; This spontaneous case was reported by an other health care professional and describes the occurrence of PRODUCT ADMINISTERED TO PATIENT OF INAPPROPRIATE AGE (15 year old received primary series of possibly Moderna COVID-19 vaccine) 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.   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 PRODUCT ADMINISTERED TO PATIENT OF INAPPROPRIATE AGE (15 year old received primary series of possibly Moderna COVID-19 vaccine). At the time of the report, PRODUCT ADMINISTERED TO PATIENT OF INAPPROPRIATE AGE (15 year old received primary series of possibly Moderna COVID-19 vaccine) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   Concomitant medication use was unknown Treatment information was unknown   Reporter did not allow further contact
Age: 71.0
Sex: M
Vaccine: COVID19
Symptoms: Chills, Diarrhoea, Erythema, Feeling hot, Headache
Clinical narrative: I had diarrhea from it, I think; was tender around where the injection was; headache; I was chilling; fever; hot to the touch; 2 inch circle that was slightly raised; I had a red area that was about size of a 2 inch circle; This spontaneous case was reported by a consumer and describes the occurrence of FEELING HOT (hot to the touch), URTICARIA (2 inch circle that was slightly raised), ERYTHEMA (I had a red area that was about size of a 2 inch circle), DIARRHOEA (I had diarrhea from it, I think) and VACCINATION SITE PAIN (was tender around where the injection was) in a 71-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 021H21B and 038B21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.   On 03-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 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 03-Dec-2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 03-Dec-2021, the patient experienced FEELING HOT (hot to the touch), URTICARIA (2 inch circle that was slightly raised), ERYTHEMA (I had a red area that was about size of a 2 inch circle), VACCINATION SITE PAIN (was tender around where the injection was), HEADACHE (headache), CHILLS (I was chilling) and PYREXIA (fever). On 05-Dec-2021, the patient experienced DIARRHOEA (I had diarrhea from it, I think). On 08-Dec-2021, ERYTHEMA (I had a red area that was about size of a 2 inch circle) had resolved. At the time of the report, FEELING HOT (hot to the touch), URTICARIA (2 inch circle that was slightly raised), DIARRHOEA (I had diarrhea from it, I think), HEADACHE (headache), CHILLS (I was chilling) and PYREXIA (fever) outcome was unknown and VACCINATION SITE PAIN (was tender around where the injection was) had not resolved.            No Concomitant medication was reported.     No treatment medications were reported.
Age: 71.0
Sex: M
Vaccine: COVID19
Symptoms: Pyrexia, Urticaria, Vaccination site pain
Clinical narrative: I had diarrhea from it, I think; was tender around where the injection was; headache; I was chilling; fever; hot to the touch; 2 inch circle that was slightly raised; I had a red area that was about size of a 2 inch circle; This spontaneous case was reported by a consumer and describes the occurrence of FEELING HOT (hot to the touch), URTICARIA (2 inch circle that was slightly raised), ERYTHEMA (I had a red area that was about size of a 2 inch circle), DIARRHOEA (I had diarrhea from it, I think) and VACCINATION SITE PAIN (was tender around where the injection was) in a 71-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 021H21B and 038B21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.   On 03-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 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 03-Dec-2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 03-Dec-2021, the patient experienced FEELING HOT (hot to the touch), URTICARIA (2 inch circle that was slightly raised), ERYTHEMA (I had a red area that was about size of a 2 inch circle), VACCINATION SITE PAIN (was tender around where the injection was), HEADACHE (headache), CHILLS (I was chilling) and PYREXIA (fever). On 05-Dec-2021, the patient experienced DIARRHOEA (I had diarrhea from it, I think). On 08-Dec-2021, ERYTHEMA (I had a red area that was about size of a 2 inch circle) had resolved. At the time of the report, FEELING HOT (hot to the touch), URTICARIA (2 inch circle that was slightly raised), DIARRHOEA (I had diarrhea from it, I think), HEADACHE (headache), CHILLS (I was chilling) and PYREXIA (fever) outcome was unknown and VACCINATION SITE PAIN (was tender around where the injection was) had not resolved.            No Concomitant medication was reported.     No treatment medications were reported.
Sex: U
Vaccine: COVID19
Symptoms: Headache
Clinical narrative: headaches that won't go away; This spontaneous case was reported by a nurse and describes the occurrence of HEADACHE (headaches that won't go away) 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 HEADACHE (headaches that won't go away). At the time of the report, HEADACHE (headaches that won't go away) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant medications reported. No treatment reported.
Age: 34.0
Sex: M
Vaccine: COVID19
Symptoms: Vaccination complication
Clinical narrative: reports not much of reaction; This spontaneous case was reported by a patient and describes the occurrence of VACCINATION COMPLICATION (reports not much of reaction) in a 34-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 006M20A) for COVID-19 vaccination.     The patient's past medical history included Blood pressure high (Patient has high blood pressure a year ago from licorice tea).    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 VACCINATION COMPLICATION (reports not much of reaction). At the time of the report, VACCINATION COMPLICATION (reports not much of reaction) outcome was unknown.        mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) dosing remained unchanged.       Concomitant medication information was not provided by the reporter.  Treatment information was not provided by the reporter.   This case was linked to MOD-2021-406577, MOD-2021-406578 (Patient Link).
Age: 75.0
Sex: M
Vaccine: COVID19
Symptoms: Dizziness, Musculoskeletal stiffness, Paraesthesia
Clinical narrative: Has dizziness when he wakes up; He has stiffness on the left; Tingling on the left side of body/Tingling from arm to knee; This spontaneous case was reported by a consumer and describes the occurrence of MUSCULOSKELETAL STIFFNESS, PARAESTHESIA, and DIZZINESS in a 75-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 003A21A and 032B21A) for COVID-19 vaccination.     No medical history was provided by the reporter.  Concurrent medical conditions included Enlarged prostate.   On 06-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 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 04-May-2021, the patient experienced MUSCULOSKELETAL STIFFNESS and PARAESTHESIA. On an unknown date, the patient experienced DIZZINESS. At the time of the report, MUSCULOSKELETAL STIFFNESS, PARAESTHESIA and DIZZINESS had not resolved.            Concomitant list included medication for enlarge prostate.  No treatment medications were reported.
Sex: U
Vaccine: COVID19
Symptoms: Expired product administered, Product storage error
Clinical narrative: administered 2 doses from vials that were stored for more than 30 days at the fridge; administered 2 doses from vials that were stored for more than 30 days at the fridge; This spontaneous case was reported by a physician and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (administered 2 doses from vials that were stored for more than 30 days at the fridge) and PRODUCT STORAGE ERROR (administered 2 doses from vials that were stored for more than 30 days at the fridge) in a  patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 033F21A) for COVID-19 vaccination.     No Medical History information was reported.    On 08-Dec-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 08-Dec-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (administered 2 doses from vials that were stored for more than 30 days at the fridge) and PRODUCT STORAGE ERROR (administered 2 doses from vials that were stored for more than 30 days at the fridge). On 08-Dec-2021, EXPIRED PRODUCT ADMINISTERED (administered 2 doses from vials that were stored for more than 30 days at the fridge) and PRODUCT STORAGE ERROR (administered 2 doses from vials that were stored for more than 30 days at the fridge) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No Concomitant medications were reported. No Treatment mediations were reported.
Age: 71.0
Sex: F
Vaccine: COVID19
Symptoms: Vaccination complication
Clinical narrative: sensation going to her body, throat and ears; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION COMPLICATION (sensation going to her body, throat and ears) in a 71-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 045J21A) for COVID-19 vaccination.     No Medical History information was reported.   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 03-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 COMPLICATION (sensation going to her body, throat and ears). At the time of the report, VACCINATION COMPLICATION (sensation going to her body, throat and ears) outcome was unknown.            Concomitant medication information was not provided by the reporter.  Treatment information was not provided by the reporter.
Sex: M
Vaccine: COVID19
Symptoms: Accidental overdose
Clinical narrative: Patient who received a booster dose at .5mL; This spontaneous case was reported by a pharmacist and describes the occurrence of ACCIDENTAL OVERDOSE (Patient who received a booster dose at .5mL) in a male patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     Concurrent medical conditions included Hypertension, Diabetes and Asthma.    On 02-Dec-2021, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) .5 ml. On 02-Dec-2021, the patient experienced ACCIDENTAL OVERDOSE (Patient who received a booster dose at .5mL). On 02-Dec-2021, ACCIDENTAL OVERDOSE (Patient who received a booster dose at .5mL) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No relevant concomitant medications were reported. No treatment information was provided.
Age: 59.0
Sex: F
Vaccine: COVID19
Symptoms: Inappropriate schedule of product administration
Clinical narrative: 1st dose: 31Jan2021 & 2nd dose: 11Feb2021; This spontaneous case was reported by a patient and describes the occurrence of INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (1st dose: 31Jan2021 & 2nd dose: 11Feb2021) in a 59-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 030M20A, 041L20A and 030M20A) for COVID-19 vaccination.     Concomitant products included OMEPRAZOLE for Nausea and Heartburn, PREDNISONE for Rheumatoid arthritis, LEVOTHYROXINE SODIUM (SYNTHROID), ACETAZOLAMIDE, GABAPENTIN, BENZONATATE, CLONAZEPAM, FOLIC ACID, LEFLUNOMIDE, FAMOTIDINE (PEPCID AC), MILNACIPRAN HYDROCHLORIDE (SAVELLA), RITUXIMAB (RITUXAN), VITAMIN B COMPLEX (B COMPLEX [VITAMIN B COMPLEX]) and ZINC for an unknown indication.   On 31-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 11-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 19-Nov-2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 11-Feb-2021, the patient experienced INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (1st dose: 31Jan2021 & 2nd dose: 11Feb2021). On 11-Feb-2021, INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (1st dose: 31Jan2021 & 2nd dose: 11Feb2021) had resolved.            No Treatment medication were reported.   This case was linked to MOD-2021-406584 (Patient Link).
Sex: U
Vaccine: COVID19
Symptoms: Pain in extremity
Clinical narrative: "How long will my arm hurt; This spontaneous case was reported by an other health care professional and describes the occurrence of PAIN IN EXTREMITY ("How long will my arm hurt) in a  patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On an unknown date, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced PAIN IN EXTREMITY ("How long will my arm hurt). At the time of the report, PAIN IN EXTREMITY ("How long will my arm hurt) had not resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No relevant concomitant medications were reported. No treatment information was provided.
Age: 40.0
Sex: F
Vaccine: COVID19
Symptoms: Blood test, Leukocytosis
Clinical narrative: leukocytosis/ more than 4000 for white cells; This spontaneous case was reported by a pharmacist and describes the occurrence of LEUKOCYTOSIS (leukocytosis/ more than 4000 for white cells) in a 40-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On an unknown date, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced LEUKOCYTOSIS (leukocytosis/ more than 4000 for white cells). At the time of the report, LEUKOCYTOSIS (leukocytosis/ more than 4000 for white cells) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, Blood test: 4000 white cells (Inconclusive) more than 4000 for white cells.     For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No Concomitant Medications were provided by the reporter  No Treatment Information were provided by the reporter
Age: 43.0
Sex: F
Vaccine: COVID19
Symptoms: Inappropriate schedule of product administration
Clinical narrative: Received J&J, then completed Moderna Series; This spontaneous case was reported by a pharmacist and describes the occurrence of INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Received J&J, then completed Moderna Series) in a 43-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 939902 and 052E21A) for COVID-19 vaccination.     The patient's past medical history included Chemotherapy (The patient was receiving chemotherapy at that time of the Janssen COVID-19 Vaccine.). Previously administered products included for COVID-19 vaccination: JANSSEN COVID-19 VACCINE (First dose) on 06-Apr-2021. Past adverse reactions to the above products included No adverse event with JANSSEN COVID-19 VACCINE. Concurrent medical conditions included Immunocompromised.   On 20-Aug-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 17-Sep-2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 20-Aug-2021, the patient experienced INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Received J&J, then completed Moderna Series). On 20-Aug-2021, INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Received J&J, then completed Moderna Series) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   No concomitant medications reported. No treatment reported. The Oncologist recommended starting the Moderna series after receiving the J&J dose. Patient was trying to receive the next dose of Moderna at the time of this report.
Sex: U
Vaccine: COVID19
Symptoms: Expired product administered
Clinical narrative: Dose given beyond 12 hours vial open; This spontaneous case was reported by a nurse and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Dose given beyond 12 hours vial open) in a  patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On 08-Dec-2021, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 08-Dec-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (Dose given beyond 12 hours vial open). On 08-Dec-2021, EXPIRED PRODUCT ADMINISTERED (Dose given beyond 12 hours vial open) had resolved. Not Provided      For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   The patient was given a booster dose on 08-Dec-2021 before 9am from a Moderna vial that had been open on 07-Dec-2021 at 8:15. The vial was taken out of fridge at 7:45am on 07-Dec-2021 and then used throughout the day and left at room temperature.  No Concomitant product use was reported. No treatment information was provided.   Most recent FOLLOW-UP information incorporated above includes: On 08-Dec-2021: Non significant information was received.
Sex: M
Vaccine: COVID19
Symptoms: Influenza like illness, Pain in extremity
Clinical narrative: Sore arm after each dose; very mild flu like symptoms after each dose; This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (Sore arm after each dose) and INFLUENZA LIKE ILLNESS (very mild flu like symptoms after each dose) in a male patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 009C21A) for COVID-19 vaccination.     No Medical History information was reported.    On 27-Apr-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 PAIN IN EXTREMITY (Sore arm after each dose) and INFLUENZA LIKE ILLNESS (very mild flu like symptoms after each dose). At the time of the report, PAIN IN EXTREMITY (Sore arm after each dose) and INFLUENZA LIKE ILLNESS (very mild flu like symptoms after each dose) outcome was unknown.            No concomitant medications were reported. No treatment medications were reported.   This case was linked to MOD-2021-406661, MOD-2021-406673, MOD-2021-406558 (Patient Link).
Age: 40.0
Sex: F
Vaccine: COVID19
Symptoms: Expired product administered
Clinical narrative: Dose administered >12 hours post puncture; This spontaneous case was reported by an other health care professional and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Dose administered >12 hours post puncture) in a 40-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 017f21a) for COVID-19 vaccination.     No Medical History information was reported.    On 07-Dec-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 07-Dec-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (Dose administered >12 hours post puncture). On 07-Dec-2021, EXPIRED PRODUCT ADMINISTERED (Dose administered >12 hours post puncture) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   It was reported that, date the vial was initially stored in the refrigerator was 30-Nov-2021. Date the vial was first punctured was on 30-Nov-2021 time is assumed around 8AM. Date of administration of vaccine was on the 30-Nov-2021 only a fraction was given and on 07-Dec-2021, 13 patients received doses from those vials.
Sex: U
Vaccine: COVID19
Symptoms: Expired product administered, Product storage error
Clinical narrative: our refrigerator was not up to standard for vaccine storage; have already given all the doses and did not know at the time; This spontaneous case was reported by a health care professional and describes the occurrence of PRODUCT STORAGE ERROR (our refrigerator was not up to standard for vaccine storage) and EXPIRED PRODUCT ADMINISTERED (have already given all the doses and did not know at the time) 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 PRODUCT STORAGE ERROR (our refrigerator was not up to standard for vaccine storage) and EXPIRED PRODUCT ADMINISTERED (have already given all the doses and did not know at the time). At the time of the report, PRODUCT STORAGE ERROR (our refrigerator was not up to standard for vaccine storage) and EXPIRED PRODUCT ADMINISTERED (have already given all the doses and did not know at the time) had resolved. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant medication reported. No treatment medication reported.
Age: 80.0
Sex: F
Vaccine: COVID19
Symptoms: Illness
Clinical narrative: got really sick the next day after the 2nd dose; This spontaneous case was reported by a consumer and describes the occurrence of ILLNESS (got really sick the next day after the 2nd dose) in an 80-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 039A21A and 031A21A) for COVID-19 vaccination.     No Medical History information was reported.   On 19-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 16-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 17-Apr-2021, the patient experienced ILLNESS (got really sick the next day after the 2nd dose). At the time of the report, ILLNESS (got really sick the next day after the 2nd dose) outcome was unknown.            Concomitant medications were not provided.  Treatment information was not provided.   This case was linked to MOD-2021-406663 (Patient Link).
Age: 50.0
Sex: M
Vaccine: COVID19
Symptoms: Expired product administered
Clinical narrative: Dose administered >12 hours post puncture; This spontaneous case was reported by an other health care professional and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Dose administered >12 hours post puncture) in a 50-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 017f21a) for COVID-19 vaccination.     No Medical History information was reported.    On 07-Dec-2021, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 07-Dec-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (Dose administered >12 hours post puncture). On 07-Dec-2021, EXPIRED PRODUCT ADMINISTERED (Dose administered >12 hours post puncture) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   Alternate email address included mlakra@myfchc.org.  No relevant concomitant medications were reported.  No treatment information was provided.  Patient  received the dose from  the  vials that were first punctured on the 30th Nov 2021 and put on the refrigerator since then.
Age: 55.0
Sex: F
Vaccine: COVID19
Symptoms: Pyrexia, Vaccination site pain
Clinical narrative: I had a low grade fever; a little bit sore at injection site; This spontaneous case was reported by a consumer and describes the occurrence of PYREXIA (I had a low grade fever) and VACCINATION SITE PAIN (a little bit sore at injection site) in a 55-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 039B21A) 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. In May 2021, the patient experienced PYREXIA (I had a low grade fever) and VACCINATION SITE PAIN (a little bit sore at injection site). At the time of the report, PYREXIA (I had a low grade fever) and VACCINATION SITE PAIN (a little bit sore at injection site) outcome was unknown.            No concomitant and treatment drug information was provided.   This case was linked to MOD-2021-406713, MOD-2021-406735 (Patient Link).
Age: 68.0
Sex: M
Vaccine: COVID19
Symptoms: Expired product administered
Clinical narrative: Received expired booster shot >12 hours post puncture; This spontaneous case was reported by a physician and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Received expired booster shot >12 hours post puncture) in a 68-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 030H21B) for COVID-19 vaccination.     No Medical History information was reported.    On 07-Dec-2021, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 07-Dec-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (Received expired booster shot >12 hours post puncture). On 07-Dec-2021, EXPIRED PRODUCT ADMINISTERED (Received expired booster shot >12 hours post puncture) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   It was reported that the Moderna COVID-19 Booster dose was administered on 07 Dec 2021 Lot 030H21B & MFG Exp. Date: 23 Mar 2022. This vial was first punctured on 06 Dec 2021 at 9:24AM and 25 hours later, on 07 DEC 2021 at 9:45AM it was administered. The vial did not experience previous excursion. The vial was first moved from Freezer to refrigerator on 06 Dec 2021.
Sex: U
Vaccine: COVID19
Symptoms: Expired product administered
Clinical narrative: Possible administration of expired vaccine past the 30 day refrigeration; This spontaneous case was reported by a pharmacist and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Possible administration of expired vaccine past the 30 day refrigeration) 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 EXPIRED PRODUCT ADMINISTERED (Possible administration of expired vaccine past the 30 day refrigeration). At the time of the report, EXPIRED PRODUCT ADMINISTERED (Possible administration of expired vaccine past the 30 day refrigeration) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No Concomitant Medications were provided by the reporter.  No Treatment Information were provided by the reporter.   Reporter did not allow further contact
Age: 86.0
Sex: M
Vaccine: COVID19
Symptoms: Bladder cancer
Clinical narrative: Bladder cancer; This spontaneous case was reported by a patient and describes the occurrence of BLADDER CANCER (Bladder cancer) in an 86-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On an unknown date, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced BLADDER CANCER (Bladder cancer) (seriousness criterion medically significant). At the time of the report, BLADDER CANCER (Bladder cancer) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No concomitant medications were provided by reporter.  Patient stated that he was diagnosed with bladder cancer about 3 or 4 months after receiving the primary doses of the Moderna COVID 19 vaccine. This is 2nd diagnosis of bladder cancer. Patient was not sure when he received the doses, but the weather was warm. He did not have his doctor's information with him. He has an appointment with his doctor tomorrow, and he will ask his doctor for more information.   Patient has chemo coming up.  COMPANY COMMENT: This is a spontaneous case concerning an 86-year-old male patient with no clinical history who experienced the unexpected event of BLADDER CANCER  The events occurred unknown days after a dose of mRNA-1273 vaccine The rechallenge was not applicable since only information about a dose was disclosed  The benefit-risk relationship of mRNA-1273 vaccine is not affected by this report.; Sender's Comments: COMPANY COMMENT: This is a spontaneous case concerning an 86-year-old male patient with no clinical history who experienced the unexpected event of BLADDER CANCER  The events occurred unknown days after a dose of mRNA-1273 vaccine The rechallenge was not applicable since only information about a dose was disclosed  The benefit-risk relationship of mRNA-1273 vaccine is not affected by this report.
Age: 11.0
Sex: U
Vaccine: COVID19
Symptoms: Product administered to patient of inappropriate age, Therapeutic response unexpected
Clinical narrative: we elected to have our 11 year old twins vaccinated; their resistance to allergens was better; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) for a Pfizer sponsored program (005570). The reporter is the parent.  A 11 year-old patient received bnt162b2 (BNT162B2) (Batch/Lot number: unknown) at the age of 11 years as dose number unknown, single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: PRODUCT ADMINISTERED TO PATIENT OF INAPPROPRIATE AGE (non-serious), outcome "unknown", described as "we elected to have our 11 year old twins vaccinated"; THERAPEUTIC RESPONSE UNEXPECTED (non-serious), outcome "unknown", described as "their resistance to allergens was better".  Additional information: When announced the vaccine safe for 12-16 year old, we elected to have our 11 year old twins vaccinated. We only had to give verbal approval, parental signature etc, so we advised they were of age to receive the vaccine. Technically, they'll be 12 this year, we didn't want them to be restricted for summer camps/events planned. We wanted to share our information and the fact they have NOT had any adverse effects, not even a sniffle, and if anything noticed their resistance to allergens was better.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.; Sender's Comments: Linked Report(s) : US-PFIZER INC-202101198729 same reporter/drug/AE, different patient
Sex: M
Vaccine: COVID19
Symptoms: Headache, Pain, SARS-CoV-2 test
Clinical narrative: Headache; body aches; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient. Other Case identifier(s): NVSC2021US141059 .  A 58 year-old male patient received bnt162b2 (BNT162B2) (Batch/Lot number: unknown) as dose number unknown, single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: HEADACHE (non-serious), outcome "unknown", described as "Headache"; PAIN (non-serious), outcome "unknown", described as "body aches". Relevant laboratory tests and procedures are available in the appropriate section. Additional information: Patient reported that he received a COVID Vaccine last month. Afterwards he experienced headache and body aches. At the time his wife tested positive for COVID but his test came back negative.  This follow-up is being submitted to notify that the lot/batch number is not available despite the follow-up attempts made. Follow-up attempts completed. No further information is expected.
Sex: F
Vaccine: COVID19
Symptoms: Vaccination site erythema, Vaccination site rash, Vaccination site warmth
Clinical narrative: This is a spontaneous report received from a contactable consumer or other non-HCP (patient). A female patient received the 3rd (booster) dose of BNT162B2 (Comirnaty, batch/lot# unknown), single dose, for COVID-19 immunisation. The patient's medical history and concomitant medications not reported. The patient reported vaccination site rash/rash to right upper arm above the elbow where she had the shot, vaccination site erythema/rash still has redness and vaccination site warmth/rash feels hot; all with outcome of unknown. Follow-up (Nov 24, 2021): This follow-up is being submitted to notify that the batch/lot number is not available despite the attempts made. Follow-up attempts completed. No further information expected.
Sex: F
Vaccine: COVID19
Symptoms: Limb discomfort
Clinical narrative: sore arm; This is a spontaneous report received from a contactable reporter(s) (Pharmacist) from medical information team.  A female patient received bnt162b2 (BNT162B2) (Batch/Lot number: unknown) as dose 1, single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: LIMB DISCOMFORT (non-serious), outcome "unknown", described as "sore arm". Additional Information:Patient got 2 booster doses of the Pfizer Biontech COVID19 vaccine within a week. It happened yesterday when patient about to get the flu shot. Response Stated that the information provided is not specific to 2 booster doses being administered but to inadvertent administration of higher than authorized dose. No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Sex: M
Vaccine: COVID19
Symptoms: Pain
Clinical narrative: had a few aches; had a few pains; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP).  A male patient received bnt162b2 (BNT162B2), administration date 07Oct2021 (Batch/Lot number: unknown) as dose 3(booster), single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: Bnt162b2 (Dose: 1), for COVID-19 immunisation; Bnt162b2 (Dose: 2), for COVID-19 immunisation. The following information was reported: PAIN (non-serious) with onset 08Oct2021, outcome "unknown", described as "had a few aches; had a few pains".  Additional information: The reporter was unwilling to complete the report when asked about the lot number. The NDC number and expiry date was not provided. There were no other products or investigation assessment provided. The patient was at home because of the event.   No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.