chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 50.0
Sex: F
Vaccine: COVID19
Symptoms: Renal disorder, Weight decreased
Clinical narrative: SHORTNESS OF BREATH; ERRATIC BLOOD PRESSURE; APPETITE LOSS; WEIGHT LOSS 5 LBS; DIZZINESS AND LIGHT HEADEDNESS; TIGHTNESS IN CHEST; MIGRANE; HARMONE FLUCTUATIONS; KIDNEY DISEASE FLARED UP; JOINT PAIN; FATIGUED; NAUSEA; INJECTION SITE PAIN; ELEVATED PLATELET COUNT; RASHES UNDER BOTH ARMS IN THE ARMPIT AREA; FEVERISH; MUSCLE ACHES/ LOTS OF ACHES AND PAIN POST VACCINATION; SLEPT FOR 36 HOURS; MEMORY WAS VERY HAZY; This spontaneous report received from a patient concerned a 50 year old female. The patient's height, and weight were not reported. The patient's concurrent conditions included: sulfa drug allergy, stage1 kidney disease, penicillin allergy, and migrane. The patient experienced drug allergy when treated with amoxicillin/clavulanate potassium, and sulfamethoxazole/trimethoprim. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 203A21A, and expiry: UNKNOWN) dose was not reported, administered on 21-JUL-2021 for prophylactic vaccination. Concomitant medications included lisinopril, and propranolol. On JUL-2021, the patient experienced memory was very hazy. On 21-JUL-2021, the patient experienced slept for 36 hours. On 21-JUL-2021, the patient experienced muscle aches/ lots of aches and pain post vaccination. On 21-JUL-2021, the patient experienced feverish. Laboratory data included: Body temperature (NR: not provided) 103 F. On AUG-2021, the patient experienced rashes under both arms in the armpit area. On 03-NOV-2021, the patient experienced elevated platelet count. Laboratory data included: Blood test (NR: not provided) ELEVATED PLATELET COUNT. On an unspecified date, the patient experienced shortness of breath, erratic blood pressure, appetite loss, weight loss 5 lbs, dizziness and light headedness, kidney disease flared up, tightness in chest, migrane, harmone fluctuations, joint pain, fatigued, nausea, and injection site pain. Laboratory data (dates unspecified) included: Blood pressure (NR: not provided) ERRATIC. Treatment medications (dates unspecified) included: pramocaine hydrochloride. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from erratic blood pressure, appetite loss, muscle aches/ lots of aches and pain post vaccination, and feverish, and memory was very hazy on JUL-2021, was recovering from weight loss 5 lbs, had not recovered from elevated platelet count, shortness of breath, rashes under both arms in the armpit area, dizziness and light headedness, nausea, fatigued, joint pain, injection site pain, and migrane, and the outcome of tightness in chest, slept for 36 hours, kidney disease flared up and harmone fluctuations was not reported. This report was non-serious.
Age: 55.0
Sex: F
Vaccine: COVID19
Symptoms: Body temperature, Hyperhidrosis, Influenza like illness, Injection site pain, Nausea
Clinical narrative: SWEATY; EARLY FLU SYMPTOMS; QUEASINESS; PAINFUL INJECTION; This spontaneous report received from a patient concerned a 55 year old female. The patient's height, and weight were not reported. The patient's concurrent conditions included: hypothyroidism, and peg (polyethylene glycol) allergy, and other pre-existing medical conditions included: Patient was taking birth control pills daily. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 1808609, expiry: 09-JUN-2021) dose was not reported, administered on 27-FEB-2021 for prophylactic vaccination. Concomitant medications included levothyroxine sodium for hypothyroidism. On 27-FEB-2021, the patient experienced painful injection. On 28-FEB-2021, the patient experienced early flu symptoms. On 28-FEB-2021, the patient experienced queasiness. Laboratory data included: Body temperature (not provided) less than 100. On 01-MAR-2021, the patient experienced sweaty. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from early flu symptoms, painful injection on 27-FEB-2021, and sweaty, and queasiness on 01-MAR-2021. This report was non-serious. This case, from the same reporter is linked to 20211203600.
Sex: U
Vaccine: COVID19
Symptoms: Illness, Pyrexia
Clinical narrative: SICK; 102 FEVER; This spontaneous report received from a patient via a company representative 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, intramuscular, batch number: Unknown) dose, start therapy date were not reported for prophylactic vaccination. No concomitant medications were reported. The batch number was not reported. The Company is unable to perform follow-up to request batch/lot numbers. On an unspecified date, the patient experienced sick, and 102 fever. Laboratory data (dates unspecified) included: Fever (NR: not provided) 102. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the 102 fever, and sick was not reported. This report was non-serious.
Sex: U
Vaccine: COVID19
Symptoms: COVID-19
Clinical narrative: COVID AFTER 75 DAYS OF VACCINATION; This spontaneous report received from a patient via a company representative 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 was not reported, administered on SEP-2021 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 covid after 75 days of vaccination. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of covid after 75 days of vaccination was not reported. This report was non-serious. This report was associated with product quality complaint: 90000205039.
Sex: M
Vaccine: COVID19
Symptoms: Head discomfort
Clinical narrative: HEAD RUSHED LIKE THE SENSATION OF WOOZINESS WHEN YOU STAND UP; This spontaneous report received from a parent concerned a 28 year old male. 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. Per procedure, no follow-up will be requested for this case. No concomitant medications were reported.  On an unspecified date, the patient experienced head rushed like the sensation of wooziness when you stand up. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of head rushed like the sensation of wooziness when you stand up was not reported. This report was non-serious. This case, from the same reporter is linked to 20211203600.
Sex: F
Vaccine: COVID19
Symptoms: Adverse drug reaction
Clinical narrative: SEVERE SIDE  EFFECTS; This spontaneous report received from a consumer via a company representative concerned a female of unspecified age. 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 severe side effects. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of severe side effects was not reported. This report was non-serious.
Sex: M
Vaccine: COVID19
Symptoms: Body temperature, Fatigue, Headache, Pyrexia
Clinical narrative: FEVER 101 F; FATIGUE; HEADACHE; This spontaneous report received from a parent concerned a 19 year old male. The patient's height, and weight were not reported. The patient's pre-existing medical conditions included: Patient was 19 year old healthy. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 213D21A expiry: UNKNOWN) dose was not reported, administered on 29-NOV-2021 for prophylactic vaccination. No concomitant medications were reported.  On 30-NOV-2021, the patient experienced fever 101 F. On 30-NOV-2021, the patient experienced fatigue. On 30-NOV-2021, the patient experienced headache. Laboratory data included: Body temperature (NR: not provided) 101 F. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from fatigue, and headache on 30-NOV-2021, and had not recovered from fever 101 F. This report was non-serious.
Sex: U
Vaccine: COVID19
Symptoms: Poor quality product administered, Product storage error
Clinical narrative: ADMINISTRATION ERROR; PUNCTURED VIAL WAS LEFT AT ROOM TEMPERATURE PAST THE 2 HOUR LIMIT; This spontaneous report received from a pharmacist concerned 5 multiple patients. 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, and batch number: 213D21A. expiry: 11-APR-2022) dose was not reported, administered on NOV-2021 for prophylactic vaccination. No concomitant medications were reported.  On NOV-2021, the patient experienced administration error. On NOV-2021, the patient experienced punctured vial was left at room temperature past the 2 hour limit. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the administration error and punctured vial was left at room temperature past the 2 hour limit was not reported. This report was non-serious. This report was associated with product quality complaint number: 90000205013.
Sex: F
Vaccine: COVID19
Symptoms: Fatigue, Pain in extremity
Clinical narrative: SORE ARM; FATIGUE; This spontaneous report received from a patient concerned a female of unspecified age. 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 was not reported, administered on 02-APR-2021 for prophylactic vaccination. The batch number was not reported and has been requested. No concomitant medications were reported. On an unspecified date, the patient experienced sore arm, and fatigue. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from sore arm, and fatigue. This report was non-serious.
Sex: F
Vaccine: COVID19
Symptoms: Computerised tomogram, Headache
Clinical narrative: HEADACHES FOR THREE WEEKS; This spontaneous report received from a patient concerned a female of unspecified age. 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 was not reported, administered on APR-2021 for prophylactic vaccination. The batch number was not reported and has been requested. No concomitant medications were reported.  On an unspecified date, the patient experienced headaches for three weeks. Laboratory data (dates unspecified) included: CT scan (NR: not provided) no findings. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from headaches for three weeks. This report was non-serious.
Sex: U
Vaccine: COVID19
Symptoms: Vaccination complication
Clinical narrative: As part of the trial we have to call in when we experience symptoms; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION COMPLICATION (As part of the trial we have to call in when we experience symptoms) 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 01-Oct-2021, 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 (As part of the trial we have to call in when we experience symptoms). At the time of the report, VACCINATION COMPLICATION (As part of the trial we have to call in when we experience symptoms) had resolved.            No concomitant medication and treatment information was reported.  The patient received the booster 01Oct2021. As part of the trial, we have to call in when we experience symptoms. patient work in school and have had kids test positive. Patient had symptoms close to 3 or 4 days.    Most recent FOLLOW-UP information incorporated above includes: On 24-Nov-2021: Follow up contains No new information.
Age: 82.0
Sex: F
Vaccine: COVID19
Symptoms: Pain in extremity
Clinical narrative: This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (sore arm from the first two doses.) in an 82-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 031L20A) for COVID-19 vaccination. No Medical History information was reported. On 17-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 24-Nov-2021, the patient experienced PAIN IN EXTREMITY (sore arm from the first two doses.). At the time of the report, PAIN IN EXTREMITY (sore arm from the first two doses.) outcome was unknown. The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown. Concomitant product use was not provided by the reporter. No treatment information was provided. This case was linked to MOD-2021-400075, MOD-2021-400094 (Patient Link).
Age: 39.0
Sex: F
Vaccine: COVID19
Symptoms: Fatigue, Influenza like illness
Clinical narrative: flu like symptoms after the second dose; fatigue after the second dose; This spontaneous case was reported by a consumer and describes the occurrence of INFLUENZA LIKE ILLNESS (flu like symptoms after the second dose) and FATIGUE (fatigue after the second dose) in a 39-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 03A21B) for COVID-19 vaccination.     Concomitant products included SALINE [SODIUM CHLORIDE] for an unknown indication.    On 22-Apr-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 22-Apr-2021, the patient experienced INFLUENZA LIKE ILLNESS (flu like symptoms after the second dose) and FATIGUE (fatigue after the second dose). At the time of the report, INFLUENZA LIKE ILLNESS (flu like symptoms after the second dose) and FATIGUE (fatigue after the second dose) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   Concomitant medication included anti emetic medication. Treatment medication were not provided. The patient received her second dose in her left arm shoulder deltoid muscle. anti emetic medication   This case was linked to MOD-2021-401280, MOD-2021-401418 (Patient Link).
Age: 17.0
Sex: U
Vaccine: COVID19
Symptoms: Inappropriate schedule of product administration, Product administered to patient of inappropriate age
Clinical narrative: 17 year old got the booster shot; Inappropriate schedule of vaccine administered; This spontaneous case was reported by a health care professional and describes the occurrence of PRODUCT ADMINISTERED TO PATIENT OF INAPPROPRIATE AGE (17 year old got the booster shot) and INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Inappropriate schedule of vaccine administered) in a 17-year-old patient of an unknown gender who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 012H21B) for COVID-19 vaccination.     Previously administered products included for Product used for unknown indication: Pfizer on 07-May-2021 and Pfizer on 28-May-2021. Past adverse reactions to the above products included No adverse event with Pfizer and Pfizer.    On 26-Nov-2021, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 26-Nov-2021, the patient experienced PRODUCT ADMINISTERED TO PATIENT OF INAPPROPRIATE AGE (17 year old got the booster shot) and INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Inappropriate schedule of vaccine administered). On 26-Nov-2021, PRODUCT ADMINISTERED TO PATIENT OF INAPPROPRIATE AGE (17 year old got the booster shot) and INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Inappropriate schedule of vaccine administered) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   Concomitant products were not provided.  Treatment medication were not reported.
Sex: M
Vaccine: COVID19
Symptoms: Rash
Clinical narrative: This spontaneous case was reported by a consumer and describes the occurrence of RASH (experienced a rash on his leg which has gone away.) in a male patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. No Medical History information was reported. In 2021, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. In 2021, the patient experienced RASH (experienced a rash on his leg which has gone away.). At the time of the report, RASH (experienced a rash on his leg which has gone away.) had resolved.  The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown. No Concomitant drug reported. No Treatment drug reported. Reporter reported- Not sure if it the event was after his 1st or2nd dose. Caller declined to provide further information. Also the patient in his 50s received  Moderna Covid-19 Vaccine earlier this year. Reporter did not allow further contact.
Sex: F
Vaccine: COVID19
Symptoms: Hemiplegia
Clinical narrative: Half of her body paralyzed; This spontaneous case was reported by a pharmacist and describes the occurrence of HEMIPLEGIA (Half of her body paralyzed) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 007c21a) for an unknown indication.     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 HEMIPLEGIA (Half of her body paralyzed). At the time of the report, HEMIPLEGIA (Half of her body paralyzed) had resolved. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant product use was provided by the reporter.    No treatment medications were reported.   Most recent FOLLOW-UP information incorporated above includes: On 24-Nov-2021: Follow-up received on 24 Nov 2021 contains no new information.
Sex: U
Vaccine: COVID19
Symptoms: Expired product administered, Product administration error
Clinical narrative: Expired vaccine used; Product administration error; This spontaneous case was reported by a physician and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Expired vaccine used) and PRODUCT ADMINISTRATION ERROR (Product administration error) in a  patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 038B21A) for COVID-19 vaccination.     No Medical History information was reported.    On 01-Oct-2021, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 01-Oct-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (Expired vaccine used) and PRODUCT ADMINISTRATION ERROR (Product administration error). On 01-Oct-2021, EXPIRED PRODUCT ADMINISTERED (Expired vaccine used) and PRODUCT ADMINISTRATION ERROR (Product administration error) 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 medications were reported.   This case was linked to MOD-2021-392935 (Patient Link).   Most recent FOLLOW-UP information incorporated above includes: On 25-Nov-2021: Follow up received, updated reporter's details and dose number updated as booster dose.
Sex: U
Vaccine: COVID19
Symptoms: Expired product administered
Clinical narrative: Expired vaccine used; This spontaneous case was reported by a physician and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Expired vaccine used) in a  patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 038B21A) for COVID-19 vaccination.     No Medical History information was reported.    On 12-Nov-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 12-Nov-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (Expired vaccine used). On 12-Nov-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 product use was reported. No treatment information was provided.  It was reported that the vial did not undergo any temperature excursions and the vials were received at the HCP office on 20-Aug-2021 and were stored in refrigerator till dates administered as indicated on the list 10 vials were used.  The patient received the second dose.   Most recent FOLLOW-UP information incorporated above includes: On 24-Nov-2021: Dosage number for the suspect drug was updated.
Sex: U
Vaccine: COVID19
Symptoms: Expired product administered
Clinical narrative: Expired vaccine used; This spontaneous case was reported by a physician and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Expired vaccine used) in a  patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 038B21A) for COVID-19 vaccination.     No Medical History information was reported.    On 12-Nov-2021, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 12-Nov-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (Expired vaccine used). On 12-Nov-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 provided. No treatment medications were provided.   Most recent FOLLOW-UP information incorporated above includes: On 24-Nov-2021: Significant Follow Up Appended _  Dose Information Updated.
Sex: U
Vaccine: COVID19
Symptoms: Expired product administered
Clinical narrative: This spontaneous case was reported by a physician and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Expired vaccine used) in a  patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 038B21A) for COVID-19 vaccination.  No Medical History information was reported. On 12-Nov-2021, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 12-Nov-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (Expired vaccine used). On 12-Nov-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 information was reported. No vial had went any temperature excursions and vials were stored in refrigerator till dates administered as indicated. This case was linked to MOD-2021-392458 (Patient Link). Most recent FOLLOW-UP information incorporated above includes: On 24-Nov-2021: Follow up was received, updated reporter details (address, state, city and postal code) and suspect dose number.
Sex: U
Vaccine: COVID19
Symptoms: Expired product administered, Product administration error
Clinical narrative: Expired vaccine used; Product administration error; This spontaneous case was reported by a physician and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Expired vaccine used) and PRODUCT ADMINISTRATION ERROR (Product administration error) in a  patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 038B21A) for COVID-19 vaccination.     No Medical History information was reported.    On 08-Oct-2021, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 08-Oct-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (Expired vaccine used) and PRODUCT ADMINISTRATION ERROR (Product administration error). On 08-Oct-2021, EXPIRED PRODUCT ADMINISTERED (Expired vaccine used) and PRODUCT ADMINISTRATION ERROR (Product administration error) had resolved. Not Provided      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.  It was reported that patient had no symptoms or quality issues.   This case was linked to MOD-2021-392935 (Patient Link).   Most recent FOLLOW-UP information incorporated above includes: On 25-Nov-2021: Follow up received, Reporter address and Dose information updated.
Sex: U
Vaccine: COVID19
Symptoms: Expired product administered, Product administration error
Clinical narrative: Expired vaccine used; Product administration error; This spontaneous case was reported by a physician and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Expired vaccine used) and PRODUCT ADMINISTRATION ERROR (Product administration error) in a  patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 038B21A) for COVID-19 vaccination.     No Medical History information was reported.    On 08-Oct-2021, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 08-Oct-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (Expired vaccine used) and PRODUCT ADMINISTRATION ERROR (Product administration error). On 08-Oct-2021, EXPIRED PRODUCT ADMINISTERED (Expired vaccine used) and PRODUCT ADMINISTRATION ERROR (Product administration error) had resolved. Not Provided      For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant medication was provided.  No treatment information was provided.   Most recent FOLLOW-UP information incorporated above includes: On 25-Nov-2021: Follow up received contains reporter details and dose number as booster dose.
Sex: U
Vaccine: COVID19
Symptoms: Expired product administered
Clinical narrative: Expired vaccine used; This spontaneous case was reported by a physician and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Expired vaccine used) in a  patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 038B21A) for COVID-19 vaccination.     No Medical History information was reported.    On 12-Nov-2021, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 12-Nov-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (Expired vaccine used). On 12-Nov-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 product use was reported. No treatment information was provided.  The vials were received at the HCP office on 20-Aug-2021 and were stored in refrigerator till dates administered as indicated on the list 10 vials were used.  The patient received the booster dose.   Most recent FOLLOW-UP information incorporated above includes: On 24-Nov-2021: Dose number for the suspect drug was updated.
Sex: F
Vaccine: COVID19
Symptoms: Cough, Expired product administered, Myalgia, Pyrexia
Clinical narrative: Expired vaccine used; Cough; Fever; bodyache; This spontaneous case was reported by a physician and describes the occurrence of COUGH (Cough), PYREXIA (Fever), MYALGIA (bodyache) and EXPIRED PRODUCT ADMINISTERED (Expired vaccine used) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 038B21A) for COVID-19 vaccination.     No Medical History information was reported.    On 29-Oct-2021, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. In 2021, the patient experienced COUGH (Cough), PYREXIA (Fever) and MYALGIA (bodyache). On 29-Oct-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (Expired vaccine used). On 29-Oct-2021, EXPIRED PRODUCT ADMINISTERED (Expired vaccine used) had resolved. At the time of the report, COUGH (Cough), PYREXIA (Fever) and MYALGIA (bodyache) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No Concomitant product use was reported. No treatment information was provided.  It was reported that the vial didn't undergo any temperature excursions and the vials were received at the HCP office on 20-Aug-2021 and were stored in refrigerator till dates administered as indicated on the list 10 vials were used.  The patient received the booster dose.   Most recent FOLLOW-UP information incorporated above includes: On 24-Nov-2021: Added reporter details and patient initials. New events were added. On 24-Nov-2021: Dose number for the suspect drug has been updated.
Sex: U
Vaccine: COVID19
Symptoms: Expired product administered
Clinical narrative: Expired vaccine used; This spontaneous case was reported by a physician and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Expired vaccine used) in a  patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 038B21A) for COVID-19 vaccination.     No Medical History information was reported.    On 29-Oct-2021, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 29-Oct-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (Expired vaccine used). On 29-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 medications were reported   Most recent FOLLOW-UP information incorporated above includes: On 24-Nov-2021: Significant follow up received, contains Reporter address and Dose information
Sex: U
Vaccine: COVID19
Symptoms: Expired product administered
Clinical narrative: Expired vaccine used; This spontaneous case was reported by a physician and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Expired vaccine used) in a  patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 038B21A) for COVID-19 vaccination.     No Medical History information was reported.    On 29-Oct-2021, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 29-Oct-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (Expired vaccine used). On 29-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 product use was reported. No treatment information was provided.   Most recent FOLLOW-UP information incorporated above includes: On 24-Nov-2021: Follow up received, Dose information updated(Booster dose)
Age: 59.0
Sex: M
Vaccine: COVID19
Symptoms: Expired product administered
Clinical narrative: Expired vaccine used; This spontaneous case was reported by a nurse and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Expired vaccine used) in a 59-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 046C21A) for COVID-19 vaccination.     No Medical History information was reported.    On 19-Nov-2021 at 10:00 AM, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) .5 milliliter. On 19-Nov-2021,  after starting mRNA-1273 (Moderna COVID-19 Vaccine), the patient experienced EXPIRED PRODUCT ADMINISTERED (Expired vaccine used). On 19-Nov-2021, EXPIRED PRODUCT ADMINISTERED (Expired vaccine used) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   Concomitant product information was not provided by the reporter.   No treatment information was provided.   This case was linked to MOD-2021-391981 (Patient Link).   Most recent FOLLOW-UP information incorporated above includes: On 23-Nov-2021: The follow up version is 19-Nov-2021 but taken as 23-Nov-2021 due to limitations owing the being 23-Nov-2021 of the initial version. The patient initials, date of birth, race, reporter details and dosing information updated.
Age: 93.0
Sex: F
Vaccine: COVID19
Symptoms: Chills, Headache, Insomnia, Nasopharyngitis, Tremor
Clinical narrative: Woke up in the middle of the night; Shaking; Cold; Headache; Shivering; This spontaneous case was reported by a consumer and describes the occurrence of INSOMNIA (Woke up in the middle of the night), TREMOR (Shaking), NASOPHARYNGITIS (Cold), HEADACHE (Headache) and CHILLS (Shivering) in a 94-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 058H21A, 015M20A and 048A21A) for COVID-19 vaccination.     Previously administered products included for Product used for unknown indication: Flu shot (got the flu shot in left arm sore and stated that it hurt after the shot). Past adverse reactions to the above products included Pain in arm with Flu shot. Concomitant products included VITAMINS NOS for an unknown indication.   On 14-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 14-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 23-Nov-2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On an unknown date, the patient experienced INSOMNIA (Woke up in the middle of the night), TREMOR (Shaking), NASOPHARYNGITIS (Cold), HEADACHE (Headache) and CHILLS (Shivering). At the time of the report, INSOMNIA (Woke up in the middle of the night), TREMOR (Shaking), NASOPHARYNGITIS (Cold), HEADACHE (Headache) and CHILLS (Shivering) outcome was unknown.            Other concomitant medication included some medications to keep the patient going but did not  provide names of the medications.  No treatment was received by the patient.  The patient stated that after receiving the "3rd dose" but later clarified that it was the booster dose and stated that, woke up in the middle of the night, was shaking, shivering, was cold and had a headache. The patient also stated that got the flu shot in left arm so had to get the booster dose in the right arm and stated that it hurt after the shot but got the other 2 shots in the left arm for the moderna vaccines. The patient stated that the left arm was also sore due to flu shot.
Age: 57.0
Sex: M
Vaccine: COVID19
Symptoms: Chills, Myalgia, Vaccination site swelling
Clinical narrative: Swelling of arm pit/Swelling of site where shot was given/Baseball size; Chills; Body aches; This spontaneous case was reported by a consumer and describes the occurrence of CHILLS (Chills), MYALGIA (Body aches) and VACCINATION SITE SWELLING (Swelling of arm pit/Swelling of site where shot was given/Baseball size) in a 57-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 018P21A, 030B21A and 026A21A) for COVID-19 vaccination.     No Medical History information was reported.   On 12-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 11-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 22-Nov-2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to .25 milliliter. On 22-Nov-2021, the patient experienced CHILLS (Chills) and MYALGIA (Body aches). On 23-Nov-2021, the patient experienced VACCINATION SITE SWELLING (Swelling of arm pit/Swelling of site where shot was given/Baseball size). The patient was treated with IBUPROFEN (ADVIL [IBUPROFEN]) for Adverse event, at an unspecified dose and frequency. On 22-Nov-2021, CHILLS (Chills) had resolved. On 23-Nov-2021, MYALGIA (Body aches) had resolved. At the time of the report, VACCINATION SITE SWELLING (Swelling of arm pit/Swelling of site where shot was given/Baseball size) had not resolved.            Concomitant medications were not provided.
Age: 51.0
Sex: F
Vaccine: COVID19
Symptoms: Vaccination site swelling
Clinical narrative: red swelling on the left arm; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE SWELLING (red swelling on the left arm) in a 51-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 067F21A, C31L2A and C31L2A) for COVID-19 vaccination.     Concurrent medical conditions included Allergy and Gastro-intestinal disorder NOS. Concomitant products included LUBIPROSTONE and BUPROPION for an unknown indication.   On 02-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 01-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 19-Nov-2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 19-Nov-2021, the patient experienced VACCINATION SITE SWELLING (red swelling on the left arm). At the time of the report, VACCINATION SITE SWELLING (red swelling on the left arm) had not resolved.            Other concomitant medications included Allergy medication, name was not specified and patient was also taking digestive medication. For treatment Patient put ice to reduce the swelling The swelling is still ongoing. Patient had taken her booster shot around 4 PM on Fri 19th Nov. The patient stated that She had no reaction after the first and second dose.
Sex: F
Vaccine: COVID19
Symptoms: Electric shock sensation, Feeling abnormal, Hypoaesthesia
Clinical narrative: weird sensation,feeling like funny; left lower leg started like having an electric shock; numbness on the back of the neck, near the ear; This spontaneous case was reported by a consumer and describes the occurrence of ELECTRIC SHOCK SENSATION (left lower leg started like having an electric shock), HYPOAESTHESIA (numbness on the back of the neck, near the ear) and FEELING ABNORMAL (weird sensation,feeling like funny) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 013F21A, 011C211A and 032E211A) for COVID-19 vaccination.     Concurrent medical conditions included Back disorder NOS.   On 20-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 18-May-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 22-Nov-2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 24-Nov-2021, the patient experienced ELECTRIC SHOCK SENSATION (left lower leg started like having an electric shock) and HYPOAESTHESIA (numbness on the back of the neck, near the ear). On an unknown date, the patient experienced FEELING ABNORMAL (weird sensation,feeling like funny). At the time of the report, ELECTRIC SHOCK SENSATION (left lower leg started like having an electric shock), HYPOAESTHESIA (numbness on the back of the neck, near the ear) and FEELING ABNORMAL (weird sensation,feeling like funny) outcome was unknown.            Concomitant medications include Medication for thyroid and depression. No treatment information was provided. The patient is in her 60s.
Age: 72.0
Sex: M
Vaccine: COVID19
Symptoms: Rash pruritic
Clinical narrative: Itchy upper thighs and underside of arms after 2nd shot; This spontaneous case was reported by a consumer and describes the occurrence of RASH PRURITIC (Itchy upper thighs and underside of arms after 2nd shot) in a 73-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 028L20A and 011J20A) for COVID-19 vaccination.     No medical history was provided by the reporter.    On 06-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 02-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 09-Feb-2021, the patient experienced RASH PRURITIC (Itchy upper thighs and underside of arms after 2nd shot). The patient was treated with DIPHENHYDRAMINE HYDROCHLORIDE (BENADRYL [DIPHENHYDRAMINE HYDROCHLORIDE]) for Itchy rash, at an unspecified dose and frequency and HYDROCORTISONE (HYDROCORTISONE 1% IN ABSORBASE) for Itchy rash, at an unspecified dose and frequency. On 16-Feb-2021, RASH PRURITIC (Itchy upper thighs and underside of arms after 2nd shot) had resolved.            No concomitant medications were reported.   This case was linked to MOD-2021-395833 (Patient Link).
Age: 58.0
Sex: M
Vaccine: COVID19
Symptoms: Accidental overdose, Malaise
Clinical narrative: Accidently received 2.5 ml instead of 0.25 ml of Moderna Booster vaccine; Not feeling well; This spontaneous case was reported by a pharmacist and describes the occurrence of MALAISE (Not feeling well) and ACCIDENTAL OVERDOSE (Accidently received 2.5 ml instead of 0.25 ml of Moderna Booster vaccine) in a 58-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On 17-Nov-2021, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 2.5 milliliter. In November 2021, the patient experienced MALAISE (Not feeling well). On 17-Nov-2021, the patient experienced ACCIDENTAL OVERDOSE (Accidently received 2.5 ml instead of 0.25 ml of Moderna Booster vaccine). On 17-Nov-2021, ACCIDENTAL OVERDOSE (Accidently received 2.5 ml instead of 0.25 ml of Moderna Booster vaccine) had resolved. At the time of the report, MALAISE (Not feeling well) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   Patient was administered the vaccine on left arm with 2.5 mL instead of 0.25 mL No concomitant medication were provided. No treatment information were given.
Age: 66.0
Sex: F
Vaccine: COVID19
Symptoms: Accidental overdose, Pain in extremity
Clinical narrative: Sore arm; Received 1mL for 1st and 2nd dose; This spontaneous case was reported by a nurse and describes the occurrence of PAIN IN EXTREMITY (Sore arm) and ACCIDENTAL OVERDOSE (Received 1mL for 1st and 2nd dose) in a 66-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 011M21A) for COVID-19 vaccination.     Concurrent medical conditions included Asthma. Concomitant products included ALBUTEROL [SALBUTAMOL] for Asthma.    On 13-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 milliliter. On 13-Feb-2021, the patient experienced ACCIDENTAL OVERDOSE (Received 1mL for 1st and 2nd dose). On an unknown date, the patient experienced PAIN IN EXTREMITY (Sore arm). The patient was treated with PARACETAMOL (TYLENOL [PARACETAMOL]) for Adverse event, at an unspecified dose and frequency. On 13-Feb-2021, ACCIDENTAL OVERDOSE (Received 1mL for 1st and 2nd dose) had resolved. 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 unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   Patient asked whether she will have any long-term side effects from being given 1ml each of her first and second vaccine doses.   This case was linked to MOD-2021-395750, MOD-2021-395764 (Patient Link).   Most recent FOLLOW-UP information incorporated above includes: On 27-Nov-2021: Follow-up received on 27-Nov-2021: contains Non-Significant information.
Age: 62.0
Sex: F
Vaccine: COVID19
Symptoms: Diarrhoea
Clinical narrative: severe diarrhea; This spontaneous case was reported by a consumer and describes the occurrence of DIARRHOEA (severe diarrhea) in a 62-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 032F21A, 018B21A and 027C21A) for COVID-19 vaccination.     No medical history was provided by the reporter.  Concurrent medical conditions included Huntington's disease. Concomitant products included RISPERIDONE, CLONAZEPAM, SERTRALINE HYDROCHLORIDE (ZOLOFT) and OMEPRAZOLE (PRILOSEC [OMEPRAZOLE]) for an unknown indication.   On 01-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 06-May-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 22-Nov-2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 23-Nov-2021, the patient experienced DIARRHOEA (severe diarrhea). The patient was treated with LOPERAMIDE HYDROCHLORIDE (IMODIUM) at an unspecified dose and frequency. At the time of the report, DIARRHOEA (severe diarrhea) outcome was unknown.            The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was not applicable.
Age: 66.0
Sex: F
Vaccine: COVID19
Symptoms: Nasopharyngitis
Clinical narrative: cold; This spontaneous case was reported by a nurse and describes the occurrence of NASOPHARYNGITIS (cold) in a 66-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 017F21A) for COVID-19 vaccination.     Concurrent medical conditions included Asthma. Concomitant products included ALBUTEROL [SALBUTAMOL] for Asthma.    On 22-Oct-2021, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) .25 milliliter. In 2021, the patient experienced NASOPHARYNGITIS (cold). The patient was treated with PARACETAMOL (TYLENOL [PARACETAMOL]) for Adverse event, at an unspecified dose and frequency. At the time of the report, NASOPHARYNGITIS (cold) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   This case was linked to MOD-2021-395678 (Patient Link).