chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 70.0
Sex: F
Vaccine: COVID19
Symptoms: Pyrexia
Clinical narrative: (after booster dose)loss of appetite; (after booster dose)she felt very weak.; (after booster dose)mostly fatigue; (after booster dose)chills; (after booster dose)headache; (after booster dose)fever; This spontaneous case was reported by a consumer and describes the occurrence of DECREASED APPETITE ((after booster dose)loss of appetite), ASTHENIA ((after booster dose)she felt very weak.), FATIGUE ((after booster dose)mostly fatigue), CHILLS ((after booster dose)chills) and HEADACHE ((after booster dose)headache) in a 70-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.   On 04-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, the patient experienced DECREASED APPETITE ((after booster dose)loss of appetite), ASTHENIA ((after booster dose)she felt very weak.), FATIGUE ((after booster dose)mostly fatigue), CHILLS ((after booster dose)chills), HEADACHE ((after booster dose)headache) and PYREXIA ((after booster dose)fever). At the time of the report, DECREASED APPETITE ((after booster dose)loss of appetite), ASTHENIA ((after booster dose)she felt very weak.), FATIGUE ((after booster dose)mostly fatigue), CHILLS ((after booster dose)chills), HEADACHE ((after booster dose)headache) and PYREXIA ((after booster dose)fever) outcome was unknown.            Patient was born in 1951.  Concomitant medication was not reported.   Symptoms started on ??-NOV-2021.   Treatment medication information was not provided.   This case was linked to MOD-2021-378184 (Patient Link).
Sex: F
Vaccine: COVID19
Symptoms: Chest discomfort, Erythema, Incorrect route of product administration
Clinical narrative: red and warmness on side of chest; red and warmness on side of chest; booster administered subcutaneous/injected in tricep muscle; This spontaneous case was reported by a physician and describes the occurrence of CHEST DISCOMFORT (red and warmness on side of chest), ERYTHEMA (red and warmness on side of chest) and INCORRECT ROUTE OF PRODUCT ADMINISTRATION (booster administered subcutaneous/injected in tricep muscle) 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 05-Nov-2021, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Subcutaneous) 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 05-Nov-2021, the patient experienced INCORRECT ROUTE OF PRODUCT ADMINISTRATION (booster administered subcutaneous/injected in tricep muscle). On an unknown date, the patient experienced CHEST DISCOMFORT (red and warmness on side of chest) and ERYTHEMA (red and warmness on side of chest). On 05-Nov-2021, INCORRECT ROUTE OF PRODUCT ADMINISTRATION (booster administered subcutaneous/injected in tricep muscle) had resolved. At the time of the report, CHEST DISCOMFORT (red and warmness on side of chest) and ERYTHEMA (red and warmness on side of chest) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Subcutaneous), the reporter did not provide any causality assessments.   No concomitant and treatment drugs were provided.
Age: 65.0
Sex: M
Vaccine: COVID19
Symptoms: Bronchitis, Cough, Magnetic resonance imaging, Productive cough, Rales
Clinical narrative: respiratory issue; my lungs crackle; inhale and wheeze/lungs wheeze and crackle; like having bronchitis; terrible cough/horsy cough/cough and more and more mucus keeps coming on/lots of phlegm kept coming back; more and more mucus keeps coming on; lots of phlegm kept coming back; This spontaneous case was reported by a consumer and describes the occurrence of RESPIRATORY DISORDER (respiratory issue), RALES (my lungs crackle), WHEEZING (inhale and wheeze/lungs wheeze and crackle), BRONCHITIS (like having bronchitis) and COUGH (terrible cough/horsy cough/cough and more and more mucus keeps coming on/lots of phlegm kept coming back) in a 65-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 046C21A and 091D21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     Concomitant products included ALBUTEROL [SALBUTAMOL] for Asthma.   On 13-Aug-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 10-Sep-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. In September 2021, the patient experienced RESPIRATORY DISORDER (respiratory issue), RALES (my lungs crackle), WHEEZING (inhale and wheeze/lungs wheeze and crackle), BRONCHITIS (like having bronchitis), COUGH (terrible cough/horsy cough/cough and more and more mucus keeps coming on/lots of phlegm kept coming back), SECRETION DISCHARGE (more and more mucus keeps coming on) and PRODUCTIVE COUGH (lots of phlegm kept coming back). At the time of the report, RESPIRATORY DISORDER (respiratory issue), RALES (my lungs crackle), WHEEZING (inhale and wheeze/lungs wheeze and crackle), BRONCHITIS (like having bronchitis), COUGH (terrible cough/horsy cough/cough and more and more mucus keeps coming on/lots of phlegm kept coming back), SECRETION DISCHARGE (more and more mucus keeps coming on) and PRODUCTIVE COUGH (lots of phlegm kept coming back) had not resolved.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, Magnetic resonance imaging: normal (normal) normal. On an unknown date, X-ray: normal (normal) Normal.         No concomitant medication was provided.  Doctor gave antibiotics which seemed to subside the problem but after that it went back. So patient got a second set of antibiotics for 10 more days. Patient said that he has been having this issue for around 2 months
Age: 65.0
Sex: M
Vaccine: COVID19
Symptoms: Respiratory disorder, Secretion discharge, Wheezing, X-ray
Clinical narrative: respiratory issue; my lungs crackle; inhale and wheeze/lungs wheeze and crackle; like having bronchitis; terrible cough/horsy cough/cough and more and more mucus keeps coming on/lots of phlegm kept coming back; more and more mucus keeps coming on; lots of phlegm kept coming back; This spontaneous case was reported by a consumer and describes the occurrence of RESPIRATORY DISORDER (respiratory issue), RALES (my lungs crackle), WHEEZING (inhale and wheeze/lungs wheeze and crackle), BRONCHITIS (like having bronchitis) and COUGH (terrible cough/horsy cough/cough and more and more mucus keeps coming on/lots of phlegm kept coming back) in a 65-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 046C21A and 091D21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     Concomitant products included ALBUTEROL [SALBUTAMOL] for Asthma.   On 13-Aug-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 10-Sep-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. In September 2021, the patient experienced RESPIRATORY DISORDER (respiratory issue), RALES (my lungs crackle), WHEEZING (inhale and wheeze/lungs wheeze and crackle), BRONCHITIS (like having bronchitis), COUGH (terrible cough/horsy cough/cough and more and more mucus keeps coming on/lots of phlegm kept coming back), SECRETION DISCHARGE (more and more mucus keeps coming on) and PRODUCTIVE COUGH (lots of phlegm kept coming back). At the time of the report, RESPIRATORY DISORDER (respiratory issue), RALES (my lungs crackle), WHEEZING (inhale and wheeze/lungs wheeze and crackle), BRONCHITIS (like having bronchitis), COUGH (terrible cough/horsy cough/cough and more and more mucus keeps coming on/lots of phlegm kept coming back), SECRETION DISCHARGE (more and more mucus keeps coming on) and PRODUCTIVE COUGH (lots of phlegm kept coming back) had not resolved.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, Magnetic resonance imaging: normal (normal) normal. On an unknown date, X-ray: normal (normal) Normal.         No concomitant medication was provided.  Doctor gave antibiotics which seemed to subside the problem but after that it went back. So patient got a second set of antibiotics for 10 more days. Patient said that he has been having this issue for around 2 months
Sex: M
Vaccine: COVID19
Symptoms: COVID-19, SARS-CoV-2 test
Clinical narrative: He got Covid19; This spontaneous case was reported by a consumer and describes the occurrence of COVID-19 (He got Covid19) in a male patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    In March 2021, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced COVID-19 (He got Covid19). At the time of the report, COVID-19 (He got Covid19) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): In November 2021, SARS-CoV-2 test: positive (Positive) He got Covid 19, yesterday or 2 days ago.     The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       Caller stated that her husband got Covid19,yesterday or 2 days ago, and now he was in quarantine for 10 days. Consent for Safety follow up could not be asked.  No concomitant medications were mentioned. No treatment details were reported.  This is an spontaneous case concerning an unknown years old, male patient with unknown clinical history who experienced the unexpected event of COVID-19 . The event occurred unknown days after a dose of Moderna Covid 19 vaccine. The rechallenge was not applicable since only information about one dose was disclosed The benefit-risk relationship of Moderna Covid 19 vaccine is not affected by this report. Follow up states that patient's husband has covid and is in quarantine. Yesterday the clinic gave him the antibody IV. He was diagnosed on Sunday the 7th.   Most recent FOLLOW-UP information incorporated above includes: On 10-Nov-2021: follow up received  containing significant information in narrative.; Sender's Comments: This is an spontaneous case concerning an unknown years old, male patient with unknown clinical history who experienced the unexpected event of COVID-19. The event occurred unknown days after a dose of Moderna Covid 19 vaccine. The rechallenge was not applicable since only information about one dose was disclosed The benefit-risk relationship of Moderna Covid 19 vaccine is not affected by this report.
Age: 67.0
Sex: M
Vaccine: COVID19
Symptoms: Inappropriate schedule of product administration
Clinical narrative: got second more than 35 days after the first dose; This spontaneous case was reported by a consumer and describes the occurrence of INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (got second more than 35 days after the first dose) in a 67-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 031A21A and 042LFCA) for COVID-19 vaccination.     No Medical History information was reported.   On 21-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 22-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 22-Mar-2021, the patient experienced INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (got second more than 35 days after the first dose). On 22-Mar-2021, INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (got second more than 35 days after the first dose) had resolved.            Concomitant medications was not provided by the reporter.  Treatment information was not provided.   This case was linked to MOD-2021-378281 (Patient Link).
Age: 58.0
Sex: F
Vaccine: COVID19
Symptoms: Pain in extremity
Clinical narrative: This spontaneous case was reported by a pharmacist and describes the occurrence of PAIN IN EXTREMITY (sore arm) in a 58-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. Concurrent medical conditions included Immunocompromised and Crohn's disease (on the biologic agent Humira). Concomitant products included ADALIMUMAB (HUMIRA) for Crohn's disease. On 10-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 07-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 02-Nov-2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to .25 ml. 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.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   No Treatment informations were reported.
Age: 67.0
Sex: M
Vaccine: COVID19
Symptoms: Lip swelling, Swelling face
Clinical narrative: whole face swelled up; lips swollen up; This spontaneous case was reported by a consumer and describes the occurrence of SWELLING FACE (whole face swelled up) and LIP SWELLING (lips swollen up) in a 67-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 00TFU4, 031A21A and 042LFCA) for COVID-19 vaccination.     No Medical History information was reported.   On 21-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 22-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 07-Nov-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 SWELLING FACE (whole face swelled up) and LIP SWELLING (lips swollen up). At the time of the report, SWELLING FACE (whole face swelled up) and LIP SWELLING (lips swollen up) had not resolved.            No concomitant medications reported. No treatment information was provided.   This case was linked to MOD-2021-378271 (Patient Link).
Sex: M
Vaccine: COVID19
Symptoms: Vaccination site discomfort
Clinical narrative: discomfort in his arm after doses 1 and 2; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE DISCOMFORT (discomfort in his arm after doses 1 and 2) in a male patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     The patient's past medical history included Stroke (derrame) in 2016.   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 VACCINATION SITE DISCOMFORT (discomfort in his arm after doses 1 and 2). At the time of the report, VACCINATION SITE DISCOMFORT (discomfort in his arm after doses 1 and 2) outcome was unknown.            Concomitant medications were not reported.  Treatment medications were not reported.   This case was linked to MOD-2021-378301, MOD-2021-378284 (Patient Link).
Age: 69.0
Sex: F
Vaccine: COVID19
Symptoms: Fatigue, Vaccination complication
Clinical narrative: Felt tired; Little reaction; This case was received via an unknown source (no reference has been entered for a health authority or license partner) on 08-Nov-2021 and was forwarded to Moderna on 08-Nov-2021.    This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION COMPLICATION (Little reaction) and FATIGUE (Felt tired) in a 69-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 012M20A) for COVID-19 vaccination.     No Medical History information was reported.   On 06-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 07-Feb-2021, the patient experienced FATIGUE (Felt tired). In February 2021, the patient experienced VACCINATION COMPLICATION (Little reaction). In February 2021, VACCINATION COMPLICATION (Little reaction) had resolved. At the time of the report, FATIGUE (Felt tired) outcome was unknown.       mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) dosing remained unchanged.    No relevant concomitant medications was reported. Treatment information was not provided.  This case was linked to MOD-2021-378334, MOD-2021-378335 (Patient Link).
Age: 30.0
Sex: F
Vaccine: COVID19
Symptoms: Expired product administered
Clinical narrative: This spontaneous case reported by an other healthcare professional, describes the occurrence of administered expired product (after the vial puncture time limit) in a 30-year-old female patient who received mRNA-1273 (Moderna COVID-19 vaccine, batch/lot# 052E21A) for COVID-19 immunization. No medical history reported. On Sep 15, 2021, patient received the first dose of mRNA-1273 (Moderna COVID-19 vaccine), intramuscular; 1 dosage form. On Sep 15, 2021, patient administered expired product (after the vial puncture time limit). On Sep 15, 2021, administered expired product (after  the vial puncture time limit) resolved. The reporter did not provide any causality assessments, concomitant medication or treatment information. This case linked to MOD-2021-378769 (patient link).
Age: 91.0
Sex: M
Vaccine: COVID19
Symptoms: Diarrhoea
Clinical narrative: uncontrollable diarrhea; This spontaneous case was reported by a consumer and describes the occurrence of DIARRHOEA (uncontrollable diarrhea) in a 92-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 032F21A, 012620A and 030M20A) for COVID-19 vaccination.     Concurrent medical conditions included Diabetes. Concomitant products included METFORMIN for Diabetes, SIMVASTATIN, LISINOPRIL, COLECALCIFEROL (VITAMIN D3 1000) and ACETYLSALICYLIC ACID (ASPIRIN (E.C.)) for an unknown indication.   On 13-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 10-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 01-Nov-2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 04-Nov-2021, the patient experienced DIARRHOEA (uncontrollable diarrhea). At the time of the report, DIARRHOEA (uncontrollable diarrhea) outcome was unknown.            Three days after the booster shot, on Thursday night patient 2 developed uncontrollable diarrhea. On Friday Patient went to the ER and got tested for several things and the only thing the ER HCPs recommended is that Patient 2 stop taking their Diabetes medicine, metformin.  No Treatment informations were reported.
Age: 61.0
Sex: F
Vaccine: COVID19
Symptoms: Inappropriate schedule of product administration
Clinical narrative: patient received her first dose of the Moderna COVID-19 vaccine on 07 FEB 2021 , second dose on 24 MAR 2021; This spontaneous case was reported by a consumer and describes the occurrence of INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (patient received her first dose of the Moderna COVID-19 vaccine on 07 FEB 2021 , second dose on 24 MAR 2021) in a 61-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 029A21A and 041L20A) for COVID-19 vaccination.     No Medical History Information was reported.  Concomitant products included ROSUVASTATIN and ALENDRONATE SODIUM (ALENDRONATE) for an unknown indication.   On 07-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 24-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 24-Mar-2021, the patient experienced INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (patient received her first dose of the Moderna COVID-19 vaccine on 07 FEB 2021 , second dose on 24 MAR 2021). On 24-Mar-2021, INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (patient received her first dose of the Moderna COVID-19 vaccine on 07 FEB 2021 , second dose on 24 MAR 2021) had resolved.            No treatment information was reported.   This case was linked to MOD-2021-378276 (Patient Link).
Age: 58.0
Sex: F
Vaccine: COVID19
Symptoms: Asthenia, Pain in extremity
Clinical narrative: Sore arm; a little run down for a couple of days; This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (Sore arm) and ASTHENIA (a little run down for a couple of days) in a 58-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 037K20A and 042L20A) for COVID-19 vaccination.     No medical history was provided by the reporter.  Concomitant products included VITAMIN D [VITAMIN D NOS] and POTASSIUM for an unknown indication.   On 16-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 16-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient experienced PAIN IN EXTREMITY (Sore arm) and ASTHENIA (a little run down for a couple of days). The patient was treated with PARACETAMOL (TYLENOL [PARACETAMOL]) for Weakness, at an unspecified dose and frequency. At the time of the report, PAIN IN EXTREMITY (Sore arm) outcome was unknown and ASTHENIA (a little run down for a couple of days) had resolved.        mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) dosing remained unchanged.       After the first dose patient felt a little run down for a couple of days, and then was fine, took some Tylenol and it helped. Also experienced Sore arm   This case was linked to MOD-2021-378491 (Patient Link).
Age: 56.0
Sex: F
Vaccine: COVID19
Symptoms: Accidental overdose, Illness
Clinical narrative: horribly sick; nurse stated she accidentally gave the patient a double dose of the Moderna booster: She gave 0.5ml instead of .2.; This spontaneous case was reported by a patient and describes the occurrence of ILLNESS (horribly sick) and ACCIDENTAL OVERDOSE (nurse stated she accidentally gave the patient a double dose of the Moderna booster: She gave 0.5ml instead of .2.) in a 56-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 032F21A, 001A21A and 038K20A) for COVID-19 vaccination.     No Medical History information was reported.   On 03-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 03-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 06-Nov-2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 06-Nov-2021, the patient experienced ACCIDENTAL OVERDOSE (nurse stated she accidentally gave the patient a double dose of the Moderna booster: She gave 0.5ml instead of .2.). On an unknown date, the patient experienced ILLNESS (horribly sick). On 06-Nov-2021, ACCIDENTAL OVERDOSE (nurse stated she accidentally gave the patient a double dose of the Moderna booster: She gave 0.5ml instead of .2.) had resolved. At the time of the report, ILLNESS (horribly sick) was resolving.            Concomitant product use was not provided by the reporter. Treatment information was not provided. Patient had her booster shot and flu shot at the same time.
Age: 40.0
Sex: F
Vaccine: COVID19
Symptoms: Expired product administered
Clinical narrative: Dose given from expired vaccine; This spontaneous case was reported by a nurse and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Dose given from expired vaccine) in a 40-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 033C21A) for COVID-19 vaccination.     No Medical History information was reported.    On 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 EXPIRED PRODUCT ADMINISTERED (Dose given from expired vaccine). At the time of the report, EXPIRED PRODUCT ADMINISTERED (Dose given from expired vaccine) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   Concomitant medication information was not provided by the reporter.  Treatment information was not provided by the reporter.
Sex: U
Vaccine: COVID19
Symptoms: Expired product administered
Clinical narrative: vaccine was administered today, 11-8-21 that expired 11-7-21; Based on the current case data, this case has been classified as invalid. This spontaneous case was reported by a nurse and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (vaccine was administered today, 11-8-21 that expired 11-7-21) 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-Nov-2021, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 08-Nov-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (vaccine was administered today, 11-8-21 that expired 11-7-21). On 08-Nov-2021, EXPIRED PRODUCT ADMINISTERED (vaccine was administered today, 11-8-21 that expired 11-7-21) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   Concomitant medications were not reported.  Treatment medications were not reported.   Reporter did not allow further contact
Sex: U
Vaccine: COVID19
Symptoms: Accidental underdose
Clinical narrative: transplant patient was given 0.25mL booster instead of 3rd 0.5mL dose; Based on the current case data, this case has been classified as invalid. This spontaneous case was reported by a pharmacist and describes the occurrence of ACCIDENTAL UNDERDOSE (transplant patient was given 0.25mL booster instead of 3rd 0.5mL dose) in a  patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On 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 ACCIDENTAL UNDERDOSE (transplant patient was given 0.25mL booster instead of 3rd 0.5mL dose). At the time of the report, ACCIDENTAL UNDERDOSE (transplant patient was given 0.25mL booster instead of 3rd 0.5mL dose) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   Concomitant medication information was not provided by the reporter.  Treatment information was not provided by the reporter.
Age: 69.0
Sex: F
Vaccine: COVID19
Symptoms: Fatigue, Vaccination complication
Clinical narrative: This spontaneous case reported by a consumer, describes the occurrence of vaccination complication (little reaction) and fatigue (felt tired) in a 69-year-old female patient who received mRNA-1273 (Moderna COVID-19 vaccine, batch/lot# 029A21A and 012M20A) for COVID-19 immunization. No medical history reported. On Feb 6, 2021, patient received the first dose of mRNA-1273 (Moderna COVID-19 vaccine), unknown route; 1 dosage form. On Mar 9, 2021, patient received the second dose of mRNA-1273 (Moderna COVID-19 vaccine), unknown route; 1 dosage form. On Mar 9, 2021, after the mRNA-1273 (Moderna COVID-19 vaccine), patient experienced vaccination complication (little reaction). On Mar 10, 2021, patient experienced fatigue (felt tired). In March 2021, vaccination complication (little reaction) and fatigue (felt tired) resolved. No concomitant medication or treatment information provided. This case linked to MOD-2021-378309, MOD-2021-378335 (patient link).
Sex: U
Vaccine: COVID19
Symptoms: Expired product administered
Clinical narrative: Administration of expired dose; Based on the current case data, this case has been classified as invalid. This spontaneous case was reported by a pharmacist and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Administration of expired dose) in a  patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 047C21A) for COVID-19 vaccination.     No Medical History information was reported.    On 08-Nov-2021, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 08-Nov-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (Administration of expired dose). On 08-Nov-2021, EXPIRED PRODUCT ADMINISTERED (Administration of expired dose) 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 information were reported.   Most recent FOLLOW-UP information incorporated above includes: On 08-Nov-2021: Follow up received and Contains no new information.
Age: 65.0
Sex: U
Vaccine: COVID19
Symptoms: Chills, Headache, Pyrexia
Clinical narrative: fever; chills; headache; This spontaneous case was reported by a consumer and describes the occurrence of PYREXIA (fever), CHILLS (chills) and HEADACHE (headache) in a 65-year-old patient of an unknown gender who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     Concurrent medical conditions included Drug allergy (over-react to certain medicine). Concomitant products included EPINEPHRINE (EPIPEN) for Drug allergy, VITAMIN D [VITAMIN D NOS] for an unknown indication.    In February 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 PYREXIA (fever), CHILLS (chills) and HEADACHE (headache). At the time of the report, PYREXIA (fever), CHILLS (chills) and HEADACHE (headache) outcome was unknown.        mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) dosing remained unchanged.       Patient didn't take any treatment medicine.   This case was linked to MOD-2021-378347 (Patient Link).
Age: 84.0
Sex: F
Vaccine: COVID19
Symptoms: Illness, Urinary incontinence, Vaccination complication
Clinical narrative: She gets so many symptoms for 3 days/she has had all the side effects that are on the list of general side effects; Loses control of her bladder/She could not control her urine; She was just as sick if not more sick; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION COMPLICATION (She gets so many symptoms for 3 days/she has had all the side effects that are on the list of general side effects), URINARY INCONTINENCE (Loses control of her bladder/She could not control her urine) and ILLNESS (She was just as sick if not more sick) in an 84-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 007M20A) for COVID-19 vaccination.     The patient's past medical history included COVID-19 (Halloween last year) in 2020. Concurrent medical conditions included Shortness of breath (shortness of breathe of when she had COVID-19). Concomitant products included OMEPRAZOLE, METOPROLOL, ACETYLSALICYLIC ACID (ASPIRIN (E.C.)), SIMVASTATIN, AMLODIPINE, VERAPAMIL, CHONDROITIN SULFATE SODIUM, GELATINE HYDROLYSATE, GLUCOSAMINE SULFATE, HYALURONIC ACID (GLUCOSAMINE CHONDROITIN [CHONDROITIN SULFATE SODIUM;GELATINE HYDROLYSATE;GLUCOSAMINE SULFATE;HYALURONIC ACID]) and RISEDRONATE SODIUM (RISEDRONATE) for an unknown indication.   On 27-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 24-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient experienced VACCINATION COMPLICATION (She gets so many symptoms for 3 days/she has had all the side effects that are on the list of general side effects), URINARY INCONTINENCE (Loses control of her bladder/She could not control her urine) and ILLNESS (She was just as sick if not more sick). The patient was treated with PARACETAMOL (TYLENOL [PARACETAMOL]) for Adverse event, at an unspecified dose and frequency. At the time of the report, VACCINATION COMPLICATION (She gets so many symptoms for 3 days/she has had all the side effects that are on the list of general side effects), URINARY INCONTINENCE (Loses control of her bladder/She could not control her urine) and ILLNESS (She was just as sick if not more sick) outcome was unknown.      For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   Patient told her doctor how sick she got and her doctor said she never heard all that before.  Patient still had shortness of breathe of when she had COVID-19 but it had not gotten worse.   This case was linked to MOD-2021-378251, MOD-2021-378340 (Patient Link).
Age: 84.0
Sex: F
Vaccine: COVID19
Symptoms: Vaccination complication
Clinical narrative: feels like I get COVID all over again, She gets so many symptoms for 3 days; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION COMPLICATION (feels like I get COVID all over again, She gets so many symptoms for 3 days) in an 84-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 007M20A) for COVID-19 vaccination.     No medical history was provided by the reporter.  Concomitant products included OMEPRAZOLE, METOPROLOL, SIMVASTATIN, AMLODIPINE, VERAPAMIL, CHONDROITIN SULFATE SODIUM, GELATINE HYDROLYSATE, GLUCOSAMINE SULFATE, HYALURONIC ACID (GLUCOSAMINE CHONDROITIN [CHONDROITIN SULFATE SODIUM;GELATINE HYDROLYSATE;GLUCOSAMINE SULFATE;HYALURONIC ACID]), RISEDRONATE SODIUM (RISEDRONATE) and ASPIRIN [ACETYLSALICYLIC ACID] for an unknown indication.    On 27-Jan-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 COMPLICATION (feels like I get COVID all over again, She gets so many symptoms for 3 days). At the time of the report, VACCINATION COMPLICATION (feels like I get COVID all over again, She gets so many symptoms for 3 days) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   Treatment information was not provided.   This case was linked to MOD-2021-378251, MOD-2021-378338 (Patient Link).
Age: 74.0
Sex: F
Vaccine: COVID19
Symptoms: Fatigue
Clinical narrative: Felt tired; This spontaneous case was reported by a consumer and describes the occurrence of FATIGUE (Felt tired) in a 74-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 012A21A) for COVID-19 vaccination.     Concomitant products included PREDNISONE for an unknown indication.    On 02-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 02-Mar-2021, the patient experienced FATIGUE (Felt tired). At the time of the report, FATIGUE (Felt tired) outcome was unknown.        mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosing remained unchanged.       Treatment information was not provided by the reporter.   This case was linked to MOD-2021-378349 (Patient Link).   Most recent FOLLOW-UP information incorporated above includes: On 08-Nov-2021: Follow-up was received and included no new information.
Age: 79.0
Sex: M
Vaccine: COVID19
Symptoms: Musculoskeletal stiffness, Vaccination complication, Vaccination site pruritus
Clinical narrative: Vaccination adverse reaction; I have a stiff neck; It kind of itches where they gave me the shot; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION COMPLICATION (Vaccination adverse reaction), MUSCULOSKELETAL STIFFNESS (I have a stiff neck) and VACCINATION SITE PRURITUS (It kind of itches where they gave me the shot) in a 79-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     Concurrent medical conditions included Penicillin allergy.    On 05-Nov-2021, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 05-Nov-2021, the patient experienced VACCINATION SITE PRURITUS (It kind of itches where they gave me the shot). On 07-Nov-2021, the patient experienced MUSCULOSKELETAL STIFFNESS (I have a stiff neck). On an unknown date, the patient experienced VACCINATION COMPLICATION (Vaccination adverse reaction). At the time of the report, VACCINATION COMPLICATION (Vaccination adverse reaction), MUSCULOSKELETAL STIFFNESS (I have a stiff neck) and VACCINATION SITE PRURITUS (It kind of itches where they gave me the shot) outcome was unknown.            No concomitant medications was provided by the reporter. No treatment medications was provided by the reporter. Patient didn't experience any event for first two dose, while after receiving the booster patient experienced a kind of itchy where he got shot, later patient had stiff neck, he had the wondering if its side effects. Patient is allergy to Penicillin and he has pulse and it was 58-59 which was a good, Patient self treat for his arm for the itchiness by massages on arm.
Sex: U
Vaccine: COVID19
Symptoms: Expired product administered
Clinical narrative: Doses given from expired vaccine; Based on the current case data, this case has been classified as invalid. This spontaneous case was reported by a nurse and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Doses given from expired vaccine) in a  patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 033C21A) 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 EXPIRED PRODUCT ADMINISTERED (Doses given from expired vaccine). At the time of the report, EXPIRED PRODUCT ADMINISTERED (Doses given from expired vaccine) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant  and treatment information was reported. Five doses were administered on 05-NOV-2021 and three doses were administered on 08-NOV-2021. There were 2 vials involved.
Age: 74.0
Sex: F
Vaccine: COVID19
Symptoms: Fatigue, Malaise, Pyrexia, Vaccination complication
Clinical narrative: Did not feel well after second dose; Feeling sick; Fever; Exhausted; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION COMPLICATION (Did not feel well after second dose), MALAISE (Feeling sick), PYREXIA (Fever) and FATIGUE (Exhausted) in a 74-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 018B21A and 012A21A) for COVID-19 vaccination.     No Medical History information was reported.   On 02-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 31-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 31-Mar-2021, the patient experienced VACCINATION COMPLICATION (Did not feel well after second dose), MALAISE (Feeling sick), PYREXIA (Fever) and FATIGUE (Exhausted). At the time of the report, VACCINATION COMPLICATION (Did not feel well after second dose), MALAISE (Feeling sick), PYREXIA (Fever) and FATIGUE (Exhausted) outcome was unknown.            No concomitant medication was provided by reporter.  No treatment information was provided by reporter.   This case was linked to MOD-2021-378344 (Patient Link).   Most recent FOLLOW-UP information incorporated above includes: On 08-Nov-2021: Non-Significant Follow up-Document attached
Sex: U
Vaccine: COVID19
Symptoms: Expired product administered
Clinical narrative: Dose administered after 30-day Use By Date; Based on the current case data, this case has been classified as invalid. This spontaneous case was reported by a nurse and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Dose administered after 30-day Use By Date) in a  patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 011F21A) for COVID-19 vaccination.     No Medical History information was reported.    In 2021, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. In 2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (Dose administered after 30-day Use By Date). In 2021, EXPIRED PRODUCT ADMINISTERED (Dose administered after 30-day Use By Date) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   On 16-Sep-2021, Vial was initially stored in the refrigerator. Vaccine was administered from 18-Oct-2021 to 02-Nov-2021. Concomitant medications were not reported No treatment information was provided.
Age: 68.0
Sex: F
Vaccine: COVID19
Symptoms: Arthralgia, Feeling abnormal, Headache, Rash, Vaccination site pain
Clinical narrative: felt a little not like themselves; arm hurt a little bit; achy joints; Headache; red rash underneath my breast all way down to my navel/rash below their breast to navel in the front of their torso; This spontaneous case was reported by a consumer and describes the occurrence of FEELING ABNORMAL (felt a little not like themselves), RASH (red rash underneath my breast all way down to my navel/rash below their breast to navel in the front of their torso), VACCINATION SITE PAIN (arm hurt a little bit), ARTHRALGIA (achy joints) and HEADACHE (Headache) in a 68-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 939905) for COVID-19 vaccination.     No medical history was reported.  Concomitant products included ACETYLSALICYLIC ACID, CAFFEINE, PARACETAMOL (EXCEDRIN [ACETYLSALICYLIC ACID;CAFFEINE;PARACETAMOL]) for an unknown indication.    On 06-Nov-2021, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 07-Nov-2021, the patient experienced RASH (red rash underneath my breast all way down to my navel/rash below their breast to navel in the front of their torso). On an unknown date, the patient experienced FEELING ABNORMAL (felt a little not like themselves), VACCINATION SITE PAIN (arm hurt a little bit), ARTHRALGIA (achy joints) and HEADACHE (Headache). The patient was treated with PARACETAMOL (TYLENOL [PARACETAMOL]) at a dose of as necessary. At the time of the report, FEELING ABNORMAL (felt a little not like themselves) had resolved, RASH (red rash underneath my breast all way down to my navel/rash below their breast to navel in the front of their torso) was resolving and VACCINATION SITE PAIN (arm hurt a little bit), ARTHRALGIA (achy joints) and HEADACHE (Headache) outcome was unknown.            No Treatment information was reported   This case was linked to MOD-2021-380153, MOD-2021-380167 (Patient Link).   Most recent FOLLOW-UP information incorporated above includes: On 09-Nov-2021: Reporter contact details and Patient Demographics updated, Concomitant added, Events (Vaccination site reaction) (Headache) (Arthralgia) (Feelng Abnormal) added.
Age: 71.0
Sex: F
Vaccine: COVID19
Symptoms: Abdominal discomfort, Decreased appetite, Diarrhoea, Fatigue, Feeling cold
Clinical narrative: diarrhoea (last night); fatigue; left arm became swollen; left arm became red; left arm reacted more; Achiness; loss of appetite; upset stomach; "freezing to death"; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE REACTION (left arm reacted more), PAIN (Achiness), DECREASED APPETITE (loss of appetite), ABDOMINAL DISCOMFORT (upset stomach) and FEELING COLD ("freezing to death") in a 71-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 012F21A, 002A21A and 013L20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     Concurrent medical conditions included Drug allergy (Allergic to tramadol).   On 29-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 25-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 05-Nov-2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 05-Nov-2021, the patient experienced VACCINATION SITE REACTION (left arm reacted more), PAIN (Achiness), DECREASED APPETITE (loss of appetite), ABDOMINAL DISCOMFORT (upset stomach), FEELING COLD ("freezing to death"), FATIGUE (fatigue), VACCINATION SITE SWELLING (left arm became swollen) and VACCINATION SITE ERYTHEMA (left arm became red). On 07-Nov-2021, the patient experienced DIARRHOEA (diarrhoea (last night)). The patient was treated with PARACETAMOL (TYLENOL [PARACETAMOL]) for Adverse event, at a dose of 1 dosage form and IBUPROFEN for Adverse event, at a dose of 1 dosage form. At the time of the report, VACCINATION SITE REACTION (left arm reacted more), PAIN (Achiness), DECREASED APPETITE (loss of appetite), ABDOMINAL DISCOMFORT (upset stomach), FEELING COLD ("freezing to death"), DIARRHOEA (diarrhoea (last night)), VACCINATION SITE SWELLING (left arm became swollen) and VACCINATION SITE ERYTHEMA (left arm became red) was resolving and FATIGUE (fatigue) had not resolved.            Concomitant medications were not reported. The caller reported his wife is feeling better on 08 Nov 2021