chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 89.0
Sex: M
Vaccine: COVID19
Symptoms: Body temperature, Chills, Influenza like illness, Pain, Pyrexia
Clinical narrative: Shaky; Flu like symptoms; Achy; Bad chills; Had a fever a little over 99 degrees; This spontaneous case was reported by a consumer and describes the occurrence of TREMOR (Shaky), INFLUENZA LIKE ILLNESS (Flu like symptoms), PAIN (Achy), CHILLS (Bad chills) and PYREXIA (Had a fever a little over 99 degrees) in an 89-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 011F21A) for COVID-19 vaccination.     No Medical History information was reported.    On 26-Oct-2021, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 27-Oct-2021, the patient experienced TREMOR (Shaky), INFLUENZA LIKE ILLNESS (Flu like symptoms), PAIN (Achy), CHILLS (Bad chills) and PYREXIA (Had a fever a little over 99 degrees). At the time of the report, TREMOR (Shaky), INFLUENZA LIKE ILLNESS (Flu like symptoms), PAIN (Achy), CHILLS (Bad chills) and PYREXIA (Had a fever a little over 99 degrees) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 27-Oct-2021, Body temperature: 99 (High) a fever a little over 99 degrees.         No concomitant medications reported. No treatment information was provided.
Age: 89.0
Sex: M
Vaccine: COVID19
Symptoms: Tremor
Clinical narrative: Shaky; Flu like symptoms; Achy; Bad chills; Had a fever a little over 99 degrees; This spontaneous case was reported by a consumer and describes the occurrence of TREMOR (Shaky), INFLUENZA LIKE ILLNESS (Flu like symptoms), PAIN (Achy), CHILLS (Bad chills) and PYREXIA (Had a fever a little over 99 degrees) in an 89-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 011F21A) for COVID-19 vaccination.     No Medical History information was reported.    On 26-Oct-2021, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 27-Oct-2021, the patient experienced TREMOR (Shaky), INFLUENZA LIKE ILLNESS (Flu like symptoms), PAIN (Achy), CHILLS (Bad chills) and PYREXIA (Had a fever a little over 99 degrees). At the time of the report, TREMOR (Shaky), INFLUENZA LIKE ILLNESS (Flu like symptoms), PAIN (Achy), CHILLS (Bad chills) and PYREXIA (Had a fever a little over 99 degrees) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 27-Oct-2021, Body temperature: 99 (High) a fever a little over 99 degrees.         No concomitant medications reported. No treatment information was provided.
Sex: F
Vaccine: COVID19
Symptoms: Accidental overdose, Maternal exposure during pregnancy
Clinical narrative: the full dose instead of the half dose; pregnant teachers got it; This spontaneous prospective pregnancy case was reported by a consumer and describes the occurrence of ACCIDENTAL OVERDOSE (the full dose instead of the half dose) and MATERNAL EXPOSURE DURING PREGNANCY (pregnant teachers got it) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On an unknown date, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. Last menstrual period and estimated date of delivery were not provided. On an unknown date, the patient experienced ACCIDENTAL OVERDOSE (the full dose instead of the half dose) and MATERNAL EXPOSURE DURING PREGNANCY (pregnant teachers got it). At the time of the report, ACCIDENTAL OVERDOSE (the full dose instead of the half dose) and MATERNAL EXPOSURE DURING PREGNANCY (pregnant teachers got it) had resolved.            Concomitant product use was not provided by the reporter. Treatment medication use was not provided by the reporter. Company Comment: This case concerns a female patient of unknown age, with no relevant medical history, with maternal exposure during pregnancy and the additional event of accidental overdose with the third (booster dose) dose of Moderna COVID-19 vaccine. No associated adverse events were reported. The benefit-risk relationship of Moderna COVID-19 vaccine is not affected by this report.   This case was linked to MOD-2021-366021 (Patient Link).; Sender's Comments: This case concerns a female patient of unknown age, with no relevant medical history, with maternal exposure during pregnancy and the additional event of accidental overdose with the third (booster dose) dose of Moderna COVID-19 vaccine. No associated adverse events were reported. The benefit-risk relationship of Moderna COVID-19 vaccine is not affected by this report.
Age: 73.0
Sex: F
Vaccine: COVID19
Symptoms: Vaccination site pain
Clinical narrative: soreness in arm at injection site; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE PAIN (soreness in arm at injection site) in a 73-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 012A21A and 039A21A) for COVID-19 vaccination.     No Medical History information was reported.   On 28-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 28-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 28-Feb-2021, the patient experienced VACCINATION SITE PAIN (soreness in arm at injection site). At the time of the report, VACCINATION SITE PAIN (soreness in arm at injection site) outcome was unknown.        mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) dosing remained unchanged.       No concomitant medication were reported.  No treatment information was provided by the reporter.   This case was linked to MOD-2021-366413 (Patient Link).
Sex: F
Vaccine: COVID19
Symptoms: Pain in extremity
Clinical narrative: sore arm; This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (sore arm) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No medical history was provided by the reporter.  Concomitant products included IBUPROFEN (ADVIL 12 HOUR) for Toothache.    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 PAIN IN EXTREMITY (sore arm). At the time of the report, PAIN IN EXTREMITY (sore arm) outcome was unknown.            The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was not applicable  No treatment reported.
Age: 67.0
Sex: F
Vaccine: COVID19
Symptoms: Fatigue, Myalgia
Clinical narrative: felt achy; fatigued; This spontaneous case was reported by a consumer and describes the occurrence of MYALGIA (felt achy) and FATIGUE (fatigued) in a 67-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 013L20A) for COVID-19 vaccination.     No Medical History information was reported.    On 26-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 MYALGIA (felt achy) and FATIGUE (fatigued). At the time of the report, MYALGIA (felt achy) and FATIGUE (fatigued) outcome was unknown.        mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosing remained unchanged.       No relevant concomitant medications were reported.  No treatment information was provided.
Age: 23.0
Sex: M
Vaccine: COVID19
Symptoms: Fatigue, Myalgia, Therapeutic response unexpected
Clinical narrative: Improvement of Psoriasis on elbows; Fatigue; Total body soreness; This spontaneous case was reported by a consumer and describes the occurrence of THERAPEUTIC RESPONSE UNEXPECTED (Improvement of Psoriasis on elbows), FATIGUE (Fatigue) and MYALGIA (Total body soreness) in a 24-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 036A21A) for COVID-19 vaccination.     Concurrent medical conditions included Psoriasis and Autoimmune disorder.    On 08-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 08-Mar-2021, the patient experienced THERAPEUTIC RESPONSE UNEXPECTED (Improvement of Psoriasis on elbows), FATIGUE (Fatigue) and MYALGIA (Total body soreness). On 11-Mar-2021, THERAPEUTIC RESPONSE UNEXPECTED (Improvement of Psoriasis on elbows) was resolving and FATIGUE (Fatigue) and MYALGIA (Total body soreness) had resolved.        mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) dosing remained unchanged.       No concomitant medications were provided . No treatment medications were provided. He stated that he finished the antihistamines, but his face was still swollen.   This case was linked to MOD-2021-366514, MOD-2021-366526 (Patient Link).
Age: 24.0
Sex: M
Vaccine: COVID19
Symptoms: Dysphagia, Fatigue, Pharyngeal swelling, Somnolence, Swelling face
Clinical narrative: Slept after booster shot; Swelling of face after booster shot; Swelling of throat after booster shot; Difficulty swallowing after booster shot; Exhausted after booster shot; This spontaneous case was reported by a consumer and describes the occurrence of SOMNOLENCE (Slept after booster shot), SWELLING FACE (Swelling of face after booster shot), PHARYNGEAL SWELLING (Swelling of throat after booster shot), DYSPHAGIA (Difficulty swallowing after booster shot) and FATIGUE (Exhausted after booster shot) in a 24-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 076B21A) for COVID-19 vaccination.     Concurrent medical conditions included Psoriasis and Autoimmune disorder.    On 23-Oct-2021, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 23-Oct-2021, the patient experienced SOMNOLENCE (Slept after booster shot), SWELLING FACE (Swelling of face after booster shot), PHARYNGEAL SWELLING (Swelling of throat after booster shot), DYSPHAGIA (Difficulty swallowing after booster shot) and FATIGUE (Exhausted after booster shot). The patient was treated with DIPHENHYDRAMINE HYDROCHLORIDE (BENADRYL [DIPHENHYDRAMINE HYDROCHLORIDE]) for Adverse event, at an unspecified dose and frequency; FAMOTIDINE (PEPCID [FAMOTIDINE]) for Adverse event, at an unspecified dose and frequency and LORATADINE (CLARITIN [LORATADINE]) for Adverse event, at an unspecified dose and frequency. At the time of the report, SOMNOLENCE (Slept after booster shot), SWELLING FACE (Swelling of face after booster shot), PHARYNGEAL SWELLING (Swelling of throat after booster shot), DYSPHAGIA (Difficulty swallowing after booster shot) and FATIGUE (Exhausted after booster shot) outcome was unknown.            No concomitant medication were provided. Patient stated that he finished the antihistamines but his face was still swollen. Patient Thought was having allergic reaction after booster shot   Patient took his first dose on 08-Mar-2021, lot No. 036A21A and second dose on 05-Apr-2021 , lot No. 030B21A.   This case was linked to MOD-2021-366494, MOD-2021-366514 (Patient Link).
Age: 49.0
Sex: F
Vaccine: COVID19
Symptoms: Pain in extremity, Peripheral swelling, Pyrexia
Clinical narrative: Swollen arm; Very painful; Fevereal; This spontaneous case was reported by a consumer and describes the occurrence of PERIPHERAL SWELLING (Swollen arm), PAIN IN EXTREMITY (Very painful) and PYREXIA (Fevereal) in a 49-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 058E21A and 939901) for COVID-19 vaccination.     No Medical History information was reported.   On 21-Aug-2021 at 10:00 AM, 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 second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 19-Sep-2021 at 12:00 PM, the patient experienced PERIPHERAL SWELLING (Swollen arm), PAIN IN EXTREMITY (Very painful) and PYREXIA (Fevereal). On 06-Oct-2021, PERIPHERAL SWELLING (Swollen arm), PAIN IN EXTREMITY (Very painful) and PYREXIA (Fevereal) had resolved.            No concomitant medications were reported. No treatment information was provided.  The second shot caused the patient's arm to swell and also feeling fevereal and was very painful for 2 weeks. The weight of the patient is reported as 179. It was reported that the vaccine was administered at 12:00 pm on an unknown date.   This case was linked to MOD-2021-301662 (Patient Link).
Age: 85.0
Sex: F
Vaccine: COVID19
Symptoms: Antibody test, Body temperature, Erythema, Fatigue, Feeling abnormal
Clinical narrative: Pain in the arm; It was hard to walk; Feeling poorly/ like beat up; Redness all of that; Extreme tiredness; Maybe a slight headache; Body aches; This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (Pain in the arm), GAIT DISTURBANCE (It was hard to walk), FEELING ABNORMAL (Feeling poorly/ like beat up), ERYTHEMA (Redness all of that) and FATIGUE (Extreme tiredness) in an 86-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 012A21A and 012L20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.   On 12-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 12-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient experienced PAIN IN EXTREMITY (Pain in the arm) and ERYTHEMA (Redness all of that). an unknown date, the patient experienced GAIT DISTURBANCE (It was hard to walk), FEELING ABNORMAL (Feeling poorly/ like beat up), FATIGUE (Extreme tiredness), HEADACHE (Maybe a slight headache) and MYALGIA (Body aches). The patient was treated with PARACETAMOL (TYLENOL) for Adverse event, at an unspecified dose and frequency. At the time of the report, PAIN IN EXTREMITY (Pain in the arm), GAIT DISTURBANCE (It was hard to walk), FEELING ABNORMAL (Feeling poorly/ like beat up), ERYTHEMA (Redness all of that), FATIGUE (Extreme tiredness), HEADACHE (Maybe a slight headache) and MYALGIA (Body aches) had resolved.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 13-Mar-2021, Body temperature: low (Low) Low. On an unknown date, Antibody test: positive (Positive) Tested for antibodies at six months from vaccination.         Concomitant products included cholesterol medication for an unknown indication. On Friday (unspecified date) pain in the arm, redness, all of that; Saturday: low temperature, feeling poorly, body aches like beat up, extreme tiredness, it was hard to walk, maybe a slight headache.  On Sunday (unspecified date) it was a little better and by Monday she was fine.
Age: 85.0
Sex: F
Vaccine: COVID19
Symptoms: Gait disturbance, Headache, Myalgia, Pain in extremity
Clinical narrative: Pain in the arm; It was hard to walk; Feeling poorly/ like beat up; Redness all of that; Extreme tiredness; Maybe a slight headache; Body aches; This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (Pain in the arm), GAIT DISTURBANCE (It was hard to walk), FEELING ABNORMAL (Feeling poorly/ like beat up), ERYTHEMA (Redness all of that) and FATIGUE (Extreme tiredness) in an 86-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 012A21A and 012L20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.   On 12-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 12-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient experienced PAIN IN EXTREMITY (Pain in the arm) and ERYTHEMA (Redness all of that). an unknown date, the patient experienced GAIT DISTURBANCE (It was hard to walk), FEELING ABNORMAL (Feeling poorly/ like beat up), FATIGUE (Extreme tiredness), HEADACHE (Maybe a slight headache) and MYALGIA (Body aches). The patient was treated with PARACETAMOL (TYLENOL) for Adverse event, at an unspecified dose and frequency. At the time of the report, PAIN IN EXTREMITY (Pain in the arm), GAIT DISTURBANCE (It was hard to walk), FEELING ABNORMAL (Feeling poorly/ like beat up), ERYTHEMA (Redness all of that), FATIGUE (Extreme tiredness), HEADACHE (Maybe a slight headache) and MYALGIA (Body aches) had resolved.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 13-Mar-2021, Body temperature: low (Low) Low. On an unknown date, Antibody test: positive (Positive) Tested for antibodies at six months from vaccination.         Concomitant products included cholesterol medication for an unknown indication. On Friday (unspecified date) pain in the arm, redness, all of that; Saturday: low temperature, feeling poorly, body aches like beat up, extreme tiredness, it was hard to walk, maybe a slight headache.  On Sunday (unspecified date) it was a little better and by Monday she was fine.
Sex: U
Vaccine: COVID19
Symptoms: Expired product administered
Clinical narrative: 4 Patients received their 1st dose from a vial greater than 12 hours post puncture; 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 (4 Patients received their 1st dose from a vial greater than 12 hours post puncture) in a patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 076C21A) for COVID-19 vaccination.     No Medical History information was reported.    On 26-Oct-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 26-Oct-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (4 Patients received their 1st dose from a vial greater than 12 hours post puncture). On 26-Oct-2021, EXPIRED PRODUCT ADMINISTERED (4 Patients received their 1st dose from a vial greater than 12 hours post puncture) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   Concomitant and treatment medications were not reported.
Age: 42.0
Sex: M
Vaccine: COVID19
Symptoms: Expired product administered
Clinical narrative: Patient was administered a dose from an expired vial. This spontaneous case was reported by a nurse and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Patient was administered a dose from an expired vial.) in a 42-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 049E21A) for COVID-19 vaccination.     No Medical History information was reported.    On 15-Oct-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 15-Oct-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (Patient was administered a dose from an expired vial.). On 15-Oct-2021, EXPIRED PRODUCT ADMINISTERED (Patient was administered a dose from an expired vial.) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No relevant concomitant medications were provided. No treatment information was provided. Expiration date of vial was 11 Oct 2021.   This case was linked to MOD-2021-365891, MOD-2021-366043, MOD-2021-366595, MOD-2021-365742, MOD-2021-365543, MOD-2021-366925, MOD-2021-366226, MOD-2021-365600, MOD-2021-365692 (Patient Link).
Age: 86.0
Sex: M
Vaccine: COVID19
Symptoms: Expired product administered
Clinical narrative: 13 doses administered 25Oct2021/this lot number has an expiration date of 10/24/2021; This spontaneous case was reported by an other health care professional and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (13 doses administered 25Oct2021/this lot number has an expiration date of 10/24/2021) in an 86-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 026C21A) for COVID-19 vaccination.     No Medical History information was reported.   On 24-Sep-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 25-Oct-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 25-Oct-2021,  after starting mRNA-1273 (Moderna COVID-19 Vaccine), the patient experienced EXPIRED PRODUCT ADMINISTERED (13 doses administered 25Oct2021/this lot number has an expiration date of 10/24/2021). On 25-Oct-2021, EXPIRED PRODUCT ADMINISTERED (13 doses administered 25Oct2021/this lot number has an expiration date of 10/24/2021) 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 details were reported.  Moderna vaccine was pulled from the freezer on 13 Oct 2021 with a use by date of 12 Nov 2021 (30 days storage viability in the fridge) . The Moderna Vial did not have an expiration date on it. However, the Moderna Vail Expiration Date Checker states that this lot number has an expiration date of 24 Oct 2021. The expired vaccine was administered to patients on 25 Oct 2021 and 26 Oct 2021.   Most recent FOLLOW-UP information incorporated above includes: On 28-Oct-2021: Follow up document contains no new Information.
Age: 71.0
Sex: M
Vaccine: COVID19
Symptoms: Expired product administered
Clinical narrative: Expired vaccine used; This spontaneous case was reported by an other health care professional and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Expired vaccine used) in a 72-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 026C21A) for COVID-19 vaccination.     No Medical History information was reported.   On 13-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 15-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 26-Oct-2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to .25 milliliter. On 26-Oct-2021,  after starting mRNA-1273 (Moderna COVID-19 Vaccine), the patient experienced EXPIRED PRODUCT ADMINISTERED (Expired vaccine used). On 26-Oct-2021, EXPIRED PRODUCT ADMINISTERED (Expired vaccine used) had resolved. Not Provided      For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant information provided by the reporter. No treatment information provided by the reporter. It was reported that the Moderna vaccine pulled from the freezer on 13-OCT-2021 with a use by date of 12-NOV-2021 (30 days storage viability in the fridge).   This case was linked to MOD-2021-364614 (Patient Link).   Most recent FOLLOW-UP information incorporated above includes: On 28-Oct-2021: Follow up document received on 28-OCT-2021 contains no new information.
Age: 82.0
Sex: F
Vaccine: COVID19
Symptoms: Expired product administered
Clinical narrative: Expired vaccine used; This spontaneous case was reported by an other health care professional and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Expired vaccine used) in an 82-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 026C21A) for COVID-19 vaccination.     No Medical History information was reported.   On 30-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 27-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 26-Oct-2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to .25 milliliter. On 26-Oct-2021,  after starting mRNA-1273 (Moderna COVID-19 Vaccine), the patient experienced EXPIRED PRODUCT ADMINISTERED (Expired vaccine used). On 26-Oct-2021, EXPIRED PRODUCT ADMINISTERED (Expired vaccine used) 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 medications were reported.   Most recent FOLLOW-UP information incorporated above includes: On 28-Oct-2021: Follow-up received contains no new information.
Sex: F
Vaccine: COVID19
Symptoms: Vaccination complication
Clinical narrative: Had a real serious side effect, not a side effect but a reaction; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION COMPLICATION (Had a real serious side effect, not a side effect but a reaction) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On an unknown date, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced VACCINATION COMPLICATION (Had a real serious side effect, not a side effect but a reaction). At the time of the report, VACCINATION COMPLICATION (Had a real serious side effect, not a side effect but a reaction) outcome was unknown.            No concomitant medications were provided. No treatment medications were reported.
Age: 50.0
Sex: F
Vaccine: COVID19
Symptoms: Expired product administered
Clinical narrative: Expired vaccine used; This spontaneous case was reported by an other health care professional and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Expired vaccine used) in a 51-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 026C21A) for COVID-19 vaccination.     No Medical History information was reported.   On 27-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 27-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 26-Oct-2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to .5 milliliter. On 26-Oct-2021,  after starting mRNA-1273 (Moderna COVID-19 Vaccine), the patient experienced EXPIRED PRODUCT ADMINISTERED (Expired vaccine used). On 26-Oct-2021, EXPIRED PRODUCT ADMINISTERED (Expired vaccine used) had resolved. Not Provided      For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   Vial was pulled from the freezer on 13-Oct-2021 with a use by date of 12-Nov-2021 (30 days storage viability in the fridge).  No concomitant medications and no treatment medications were reported.   This case was linked to MOD-2021-364614 (Patient Link).   Most recent FOLLOW-UP information incorporated above includes: On 28-Oct-2021: Follow received contains no new information.
Age: 81.0
Sex: M
Vaccine: COVID19
Symptoms: Expired product administered
Clinical narrative: Expired vaccine used; This spontaneous case was reported by an other health care professional and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Expired vaccine used) in an 82-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 026C21A) for COVID-19 vaccination.     No Medical History information was reported.   On 28-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 25-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 26-Oct-2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to .25 ml. On 26-Oct-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (Expired vaccine used). On 26-Oct-2021, EXPIRED PRODUCT ADMINISTERED (Expired vaccine used) had resolved. Not Provided      For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No Concomitant medications were reported.   No Treatment information was reported.  Moderna vaccine was pulled from the freezer on 13 Oct 2021 with a use by date of 12 Nov 2021 (30 days storage viability in the fridge). The Moderna Vial did not have an expiration date on it. However, the Moderna Vail Expiration Date Checker states that this lot number has an expiration date of 24 Oct 2021   This case was linked to MOD-2021-367076 (Patient Link).   Most recent FOLLOW-UP information incorporated above includes: On 28-Oct-2021: Follow up received included no new information
Age: 65.0
Sex: M
Vaccine: COVID19
Symptoms: Expired product administered
Clinical narrative: Expired vaccine used; This spontaneous case was reported by an other health care professional and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Expired vaccine used) in a 65-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 026C21A) for COVID-19 vaccination.     No Medical History information was reported.   On 02-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 26-Oct-2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to .25 milliliter. On 26-Oct-2021,  after starting mRNA-1273 (Moderna COVID-19 Vaccine), the patient experienced EXPIRED PRODUCT ADMINISTERED (Expired vaccine used). On 26-Oct-2021, EXPIRED PRODUCT ADMINISTERED (Expired vaccine used) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant medications were provided. No treatment medications were provided.  The reporter stated that their Moderna vaccine was pulled from the freezer on 13-Oct-2021 with a use by date of 12-Nov-2021, 30 days storage viability in the fridge. The Moderna Vial does not have an expiration date on it, however the Moderna Vail Expiration Date Checker stated that this lot number had an expiration date of 24-Oct-2021. The patient was given vaccine from this lot number vial on 26-Oct-2021.   Most recent FOLLOW-UP information incorporated above includes: On 28-Oct-2021: Follow up was received contains no new information.
Age: 68.0
Sex: M
Vaccine: COVID19
Symptoms: Expired product administered
Clinical narrative: Expired vaccine used; This spontaneous case was reported by an other health care professional and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Expired vaccine used) in a 68-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 026C21A) for COVID-19 vaccination.     No Medical History information was reported.   On 06-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 02-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 26-Oct-2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to .25 milliliter. On 26-Oct-2021,  after starting mRNA-1273 (Moderna COVID-19 Vaccine), the patient experienced EXPIRED PRODUCT ADMINISTERED (Expired vaccine used). On 26-Oct-2021, EXPIRED PRODUCT ADMINISTERED (Expired vaccine used) had resolved. Not Provided      For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant medication was reported.  No treatment medication was reported.   Most recent FOLLOW-UP information incorporated above includes: On 28-Oct-2021: Follow up received -No new information was added.
Age: 73.0
Sex: M
Vaccine: COVID19
Symptoms: Influenza like illness
Clinical narrative: Flu-like symptoms for about 8 hrs; This spontaneous case was reported by a consumer and describes the occurrence of INFLUENZA LIKE ILLNESS (Flu-like symptoms for about 8 hrs) in a 73-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.   On 26-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 INFLUENZA LIKE ILLNESS (Flu-like symptoms for about 8 hrs). At the time of the report, INFLUENZA LIKE ILLNESS (Flu-like symptoms for about 8 hrs) had resolved.            No Concomitant product use was reported. No treatment information was provided.   The reporter who was calling on behalf of their husband reported that the patient after receiving their Moderna Covid vaccine for the second dose experienced flu-like symptoms till next day from the onset of symptom.   This case was linked to MOD-2021-368071, MOD-2021-360778 (Patient Link).
Age: 55.0
Sex: M
Vaccine: COVID19
Symptoms: Dysgeusia
Clinical narrative: Metallic taste while and after eating.
Age: 28.0
Sex: F
Vaccine: FLU4
Symptoms: Differential white blood cell count normal, Erythema, Full blood count normal, Pruritus
Clinical narrative: Severe itchiness and redness starting from groin area spreading to inner thighs and hips heavily then dispersing to upper body, neck, and extremities. No other symptoms was experienced. Itchiness did not resolve by day 5, therefore I visited urgent care center on Oct. 26, 2021 and prednisone 40 mg daily x 7 days, acyclovir 800 mg  five times daily x 7 days, Benadryl 50 mg every 4-6 hr, and Claritin 10 mg daily was prescribed.
Age: 58.0
Sex: M
Vaccine: UNK
Symptoms: Headache
Clinical narrative: I had frontal lobe headache that was present for a month.
Age: 56.0
Sex: F
Vaccine: COVID19
Symptoms: Electromyogram, Magnetic resonance imaging, Radiculitis brachial
Clinical narrative: Brachial neuritis
Age: 35.0
Sex: M
Vaccine: HPV9
Symptoms: Abdominal pain, Flatulence, Malaise, Nausea, Pyrexia
Clinical narrative: abdomen pain; gas pain; he feels "Pretty Lousy."; nausea; small fever; This spontaneous report as received from a 35 years old male patient refers to himself. The patient's concurrent conditions included Hashimoto's thyroiditis and irritable bowel syndrome (IBS). The patient was allergic to sulfur, gramicidin (+) neomycin sulfate (+) polymyxin sulfate (NEOSPORINE) and penicillin. The patient had used unspecified concomitant medications.     On 04-OCT-2021, the patient was vaccinated with hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast)(GARDASIL 9) injection (route, strength, dose, frequency, batch/lot # and expiration date were not reported) for prophylaxis (reported as human papillomavirus (HPV) prevention).         On 05-OCT-2021 (reported as this morning), the patient stated that he felt "pretty lousy." Caller stated that he was experiencing nausea, abdomen pain, gas pain and had a small fever. The outcome of all events was reported as not recovered. No treatment was given for the events. The patient had sought medical attention.   The causality was not reported.
Age: 11.0
Sex: M
Vaccine: HPV9, MNQ, TDAP
Symptoms: Transcription medication error
Clinical narrative: No additional AE reported; the first dose was not documented in the patient record/ confusion/medication error on the HCP part as to if the vaccine was administered since there is no documentation; This spontaneous report has been received from a medical assistant referring to a patient of unknown age and gender. Information about concurrent condition, concomitant medication and medical history was not provided.  On an unknown date in April 2021 (reported as 6 months ago), the patient was vaccinated the first dose of hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast)(GARDASIL 9) (0.5ml; strength, route, lot # and expiration date were not reported) for prophylaxis. The patient came back to the office on 13-OCT-2021 to receive the second dose. The medical assistant stated that the first dose was not documented in the patient record. The reporter had confusion if the vaccine was administered since there was no documentation (transcription medication error). No additional events were reported.  This is a non-valid report due to lack of patient's identifiers.  Follow up information has been received from a medical assistant on 29-OCT-2021. Upon receipt of follow up it was determined that the case was valid as the patient's identifiers were provided. This case referred to a 11 years old male patient. On 06-APR-2021, the patient was vaccinated with hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast)(GARDASIL 9) at private doctor's office/hospital. On the same day, the patient was also vaccinated with diphtheria vaccine toxoid, pertussis vaccine acellular 3-component, tetanus vaccine toxoid (BOOSTRIX) and meningococcal vaccine a/c/y/w conj (crm197)(MENVEO) (strength, dose, route, lot # and expiration date were not reported). The vaccines were not documented on that day (transcription medication error). There were no temperature excursions for above vaccines.
Sex: F
Vaccine: COVID19
Symptoms: Erythema, Myalgia, Pruritus, Swelling
Clinical narrative: swollen red spot of the size of a quarter or bigger; sore; swollen red spot of the size of a quarter or bigger; itchy; This spontaneous case was reported by a consumer and describes the occurrence of SWELLING (swollen red spot of the size of a quarter or bigger), PRURITUS (itchy), ERYTHEMA (swollen red spot of the size of a quarter or bigger) and MYALGIA (sore) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 939903) for COVID-19 vaccination.     No medical history was provided by the reporter.  Concurrent medical conditions included Hypertension (High blood pressure medications.). Concomitant products included METFORMIN for an unknown indication.   On 21-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 15-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 25-Oct-2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 25-Oct-2021, the patient experienced SWELLING (swollen red spot of the size of a quarter or bigger), PRURITUS (itchy) and MYALGIA (sore). On an unknown date, the patient experienced ERYTHEMA (swollen red spot of the size of a quarter or bigger). At the time of the report, SWELLING (swollen red spot of the size of a quarter or bigger), PRURITUS (itchy), ERYTHEMA (swollen red spot of the size of a quarter or bigger) and MYALGIA (sore) outcome was unknown.            Concomitant medication includes Cholesterol medication and High blood pressure medication. No treatment information was provided.
Age: 40.0
Sex: F
Vaccine: COVID19
Symptoms: Headache, Influenza like illness, Vision blurred
Clinical narrative: BLURRED VISION; CONSISTENT HEADACHE; FLU LIKE SYMPTOMS; This spontaneous report received from a consumer concerned a 40 year old female. The patient's height, and weight were not reported. The patient's concurrent conditions included: migraine, non-smoker, non-alcohol user, and allergy to sulpha drugs, and other pre-existing medical conditions included: The patient had no any history drug abuse or illicit drug use. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 7821287, expiry: UNKNOWN) dose was not reported, administered on 30-JUN-2021 for prophylactic vaccination. No concomitant medications were reported.  On JUL-2021, treatment medications included: ibuprofen. On 01-JUL-2021, the patient experienced flu like symptoms. On OCT-2021, the patient experienced consistent headache. On an unspecified date, the patient experienced blurred vision. Additional treatment medications (dates unspecified) included: sumatriptan. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from flu like symptoms on 03-JUL-2021, and had not recovered from consistent headache, and blurred vision. This report was non-serious. Sender's Comments: V0: Medical assessment comment is not required as per standard procedure as case is assessed as non-serious.
Age: 57.0
Sex: F
Vaccine: COVID19
Symptoms: Feeling abnormal, Herpes zoster, Impaired work ability
Clinical narrative: UNABLE TO WORK; FOGGY BRAIN FEELING INTENSIFIED; SHINGLES ON LEFT SIDE OF CHEST TO EAR; This spontaneous report received from a patient concerned a 57 year old female. The patient's height, and weight were not reported. The patient's concurrent conditions included: foggy brain, and other pre-existing medical conditions included: Patient was not pregnant at the time of reporting. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 1808982 expiry: 21-SEP-2021) dose was not reported, administered on 06-APR-2021 for prophylactic vaccination. The patient was also received non-company suspect D-trans fentanyl/naltrexone (formulation not reported, route of admin not reported, batch number: unknown expiry: unknown) dose was not reported, administered on an unspecified date for unspecified indication. Concomitant medications included naltrexone, and upadacitinib. On 27-APR-2021, the patient experienced shingles on left side of chest to ear. On 01-JUL-2021, the patient experienced foggy brain feeling intensified. On an unspecified date, the patient experienced unable to work. The action taken with covid-19 vaccine ad26.cov2.s was not applicable, and with D-trans fentanyl/naltrexone was not reported. The patient recovered from shingles on left side of chest to ear on 30-JUN-2021, had not recovered from foggy brain feeling intensified, and the outcome of unable to work was not reported. This report was non-serious. Sender's Comments: V0: Medical assessment comment is not required as per standard procedure as case assessed as non-serious.
Age: 46.0
Sex: F
Vaccine: COVID19
Symptoms: Chills, Ear pain, Hyperhidrosis, Pain, Pain in extremity
Clinical narrative: SHOOTING PAIN IN RIGHT EAR; RIGHT ARM SORE/ EXCRUCIATING PAIN IN BOTH LEGS AFTER GETTING OUT OF BATH; CHILLS; SWEATS; BODY ACHES; This spontaneous report received from a patient concerned a 46 year old female. The patient's height, and weight were not reported. The patient's concurrent conditions included: sulfa allergy, and other pre-existing medical conditions included: The patient was aware of that she do not have any medical condition and currently only taking multivitamin. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 212A21A, and expiry: UNKNOWN) dose was not reported, administered on 02-NOV-2021 15:00 for prophylactic vaccination. No concomitant medications were reported. On 02-NOV-2021, the patient experienced sweats. On 02-NOV-2021, the patient experienced body aches. On 02-NOV-2021, the patient experienced right arm sore/ excruciating pain in both legs after getting out of bath. On 02-NOV-2021, the patient experienced chills. On 03-NOV-2021, the patient experienced shooting pain in right ear. Treatment medications included: ibuprofen. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from right arm sore/ excruciating pain in both legs after getting out of bath, chills, sweats, body aches, and shooting pain in right ear. This report was non-serious.
Sex: U
Vaccine: COVID19
Symptoms: Fatigue, Feeling abnormal, Headache, Pain in extremity, Pyrexia
Clinical narrative: This spontaneous report received from a patient concerned a patient of unspecified age and sex. The patient's height, and weight were not reported. No past medical history or concurrent conditions were reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: Unknown) dose, start therapy date were not reported for prophylactic vaccination. The batch number was not reported. The Company is unable to perform follow-up to request batch/lot numbers. No concomitant medications were reported. On an unspecified date, the patient experienced arm was really sore for a while, slight fever, really tired, and headache. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the slight fever, really tired, headache, arm was really sore for a while and felt like shit was not reported. This report was non-serious.
Age: 29.0
Sex: F
Vaccine: COVID19
Symptoms: Angina pectoris, Dyspnoea, Pain, Painful respiration, Vaccination site movement impairment
Clinical narrative: Heart is hurting me,squeezing pain; She can't breathe, it is difficult to breathe, painful breathing sometimes; painful breathing sometimes; Whole left side is painful and hurting; Can't move the arm,can't put her hand up; Pain on the arm, constant pain, injection was painful, pain on the arm that is sharp; This spontaneous case was reported by a consumer and describes the occurrence of ANGINA PECTORIS (Heart is hurting me,squeezing pain) in a 29-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 076C21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.    On 15-Oct-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced ANGINA PECTORIS (Heart is hurting me,squeezing pain) (seriousness criterion medically significant), DYSPNOEA (She can't breathe, it is difficult to breathe, painful breathing sometimes), PAINFUL RESPIRATION (painful breathing sometimes), PAIN (Whole left side is painful and hurting), VACCINATION SITE MOVEMENT IMPAIRMENT (Can't move the arm,can't put her hand up) and VACCINATION SITE PAIN (Pain on the arm, constant pain, injection was painful, pain on the arm that is sharp). At the time of the report, ANGINA PECTORIS (Heart is hurting me,squeezing pain), DYSPNOEA (She can't breathe, it is difficult to breathe, painful breathing sometimes), PAINFUL RESPIRATION (painful breathing sometimes), PAIN (Whole left side is painful and hurting), VACCINATION SITE MOVEMENT IMPAIRMENT (Can't move the arm,can't put her hand up) and VACCINATION SITE PAIN (Pain on the arm, constant pain, injection was painful, pain on the arm that is sharp) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       The patient did not want to answer any more questions regarding cardiac related signs and symptoms specifically for the myocarditis and pericarditis. The patient stated that she started noticing it 4 days ago on 22Oct2021. No additional information was obtained.  Company Comment: This case concerns a 29 year-old female patient with no reported medical history, who experienced the unexpected serious event of Angina pectoris. The event occurred an unknown number of days after the first dose of mRNA-1273 vaccine. The benefit-risk relationship of mRNA-1273 vaccine is not affected by this report.; Sender's Comments: This case concerns a 29 year-old female patient with no reported medical history, who experienced the unexpected serious event of Angina pectoris. The event occurred an unknown number of days after the first dose of mRNA-1273 vaccine. The benefit-risk relationship of mRNA-1273 vaccine is not affected by this report.