chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Sex: U
Vaccine: COVID19
Symptoms: Expired product administered, Product administration error
Clinical narrative: error resulting in administration of expired vaccine; Expired vaccine used; Based on the current case data, this case has been classified as invalid. This spontaneous case was reported by a physician and describes the occurrence of PRODUCT ADMINISTRATION ERROR (error resulting in administration of expired vaccine) and 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. 003A21A) for COVID-19 vaccination.     No Medical History information was reported.    On 20-Aug-2021, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 20-Aug-2021, the patient experienced PRODUCT ADMINISTRATION ERROR (error resulting in administration of expired vaccine) and EXPIRED PRODUCT ADMINISTERED (Expired vaccine used). On 20-Aug-2021, PRODUCT ADMINISTRATION ERROR (error resulting in administration of expired vaccine) and 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.
Age: 30.0
Sex: F
Vaccine: COVID19
Symptoms: Accidental overdose
Clinical narrative: Had been given a 2.5ml dose of Moderna instead of the 0.25 ml intramuscularly to deltoid; This spontaneous case was reported by a physician and describes the occurrence of ACCIDENTAL OVERDOSE (Had been given a 2.5ml dose of Moderna instead of the 0.25 ml intramuscularly to deltoid) in a 30-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 019F21A) 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) (Intramuscular) 2.5 milliliter. On an unknown date, the patient experienced ACCIDENTAL OVERDOSE (Had been given a 2.5ml dose of Moderna instead of the 0.25 ml intramuscularly to deltoid). At the time of the report, ACCIDENTAL OVERDOSE (Had been given a 2.5ml dose of Moderna instead of the 0.25 ml intramuscularly to deltoid) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   The patient had been given a 2.5 ml dose of Moderna vaccine instead of 0.25 ml dose of vaccine. The vaccine was given by using a 3 ml syringe due to the volume needed. The patient was told that they might have a worst local reaction and potentially a significant systemic reaction and told to seek advice from emergency department or primary doctor as needed.  No Concomitant product use was reported. No treatment information was provided.
Age: 65.0
Sex: M
Vaccine: COVID19
Symptoms: Expired product administered
Clinical narrative: The vial was 1st punctured @ 9:30 am on 18Nov2021 then was left at room temperature until this dose was administered @ 8:45 am on 19Nov2021; This spontaneous case was reported by a pharmacist and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (The vial was 1st punctured @ 9:30 am on 18Nov2021 then was left at room temperature until this dose was administered @ 8:45 am on 19Nov2021) in a 65-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 039F21A) for COVID-19 vaccination.     No Medical History information was reported.    On 19-Nov-2021, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 19-Nov-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (The vial was 1st punctured @ 9:30 am on 18Nov2021 then was left at room temperature until this dose was administered @ 8:45 am on 19Nov2021). At the time of the report, EXPIRED PRODUCT ADMINISTERED (The vial was 1st punctured @ 9:30 am on 18Nov2021 then was left at room temperature until this dose was administered @ 8:45 am on 19Nov2021) outcome was unknown. Not Provided      For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   The patient received their first dose from Johnson and Johnson and the date of administration was unknown.  This is a spontaneous case concerning a 65-year-old male patient with no relevant medical history, who experienced the non serious event of expired product administered for mRNA-1273 vaccine with lot number 039F21A. The event expired product administered occurred right after the booster dose of mRNA-1273 vaccine administration, the administered mRNA-1273 vaccine was 11 hours and 15 minutes past its first punctured time. (first puncture date and time: 18 November 2021 at 9:30 A.M; mRNA-1273 vaccine administration date and time: 19 November 2021 at 8:45 A.M, mRNA-1273 vials should be discarded 12 hours after the first punctured time). The benefit-risk relationship of mRNA-1273 vaccine is not affected by this report.; Sender's Comments: This is a spontaneous case concerning a 65-year-old male patient with no relevant medical history, who experienced the non serious event of expired product administered for mRNA-1273 vaccine with lot number 039F21A. The event expired product administered occurred right after the booster dose of mRNA-1273 vaccine administration, the administered mRNA-1273 vaccine was 11 hours and 15 minutes past its first punctured time. (first puncture date and time: 18 November 2021 at 9:30 A.M; mRNA-1273 vaccine administration date and time: 19 November 2021 at 8:45 A.M, mRNA-1273 vials should be discarded 12 hours after the first punctured time). The benefit-risk relationship of mRNA-1273 vaccine is not affected by this report.
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 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.        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  Reporter stated that No symptoms or quality issues to report   Most recent FOLLOW-UP information incorporated above includes: On 22-Nov-2021: Significant follow up, patient details updated
Age: 54.0
Sex: F
Vaccine: COVID19
Symptoms: Condition aggravated, Eye swelling, Lip swelling, Swelling face, Swollen tongue
Clinical narrative: patient got up and noticed the reaction was worse; body was covered in hives/ Hives are slowly going away; Swelling of face; Patient's eyeswas swollen, Everything's still swollen, but nothing inside the mouth"; Patient's lips was swollen, Everything's still swollen, but nothing inside the mouth"; Patient's tongue was swollen, Everything's still swollen, but nothing inside the mouth"; This spontaneous case was reported by a consumer and describes the occurrence of SWELLING FACE (Swelling of face), EYE SWELLING (Patient's eyeswas swollen, Everything's still swollen, but nothing inside the mouth"), LIP SWELLING (Patient's lips was swollen, Everything's still swollen, but nothing inside the mouth"), SWOLLEN TONGUE (Patient's tongue was swollen, Everything's still swollen, but nothing inside the mouth") and CONDITION AGGRAVATED (patient got up and noticed the reaction was worse) in a 54-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 067F21A and 017F21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     Concurrent medical conditions included Seasonal allergy, Egg allergy and Hashimoto's disease. Concomitant products included LEVOTHYROXINE SODIUM (SYNTHROID) for Hashimoto's disease.   On 16-Oct-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 17-Nov-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 17-Nov-2021, the patient experienced SWELLING FACE (Swelling of face), EYE SWELLING (Patient's eyeswas swollen, Everything's still swollen, but nothing inside the mouth"), LIP SWELLING (Patient's lips was swollen, Everything's still swollen, but nothing inside the mouth"), SWOLLEN TONGUE (Patient's tongue was swollen, Everything's still swollen, but nothing inside the mouth") and URTICARIA (body was covered in hives/ Hives are slowly going away). On 18-Nov-2021, the patient experienced CONDITION AGGRAVATED (patient got up and noticed the reaction was worse). The patient was treated with DIPHENHYDRAMINE HYDROCHLORIDE (BENADRYL [DIPHENHYDRAMINE HYDROCHLORIDE]) at an unspecified dose and frequency. At the time of the report, SWELLING FACE (Swelling of face), EYE SWELLING (Patient's eyeswas swollen, Everything's still swollen, but nothing inside the mouth"), LIP SWELLING (Patient's lips was swollen, Everything's still swollen, but nothing inside the mouth") and SWOLLEN TONGUE (Patient's tongue was swollen, Everything's still swollen, but nothing inside the mouth") had not resolved, CONDITION AGGRAVATED (patient got up and noticed the reaction was worse) outcome was unknown and URTICARIA (body was covered in hives/ Hives are slowly going away) was resolving.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   This case was linked to MOD-2021-392454 (Patient Link).
Age: 54.0
Sex: F
Vaccine: COVID19
Symptoms: Urticaria
Clinical narrative: patient got up and noticed the reaction was worse; body was covered in hives/ Hives are slowly going away; Swelling of face; Patient's eyeswas swollen, Everything's still swollen, but nothing inside the mouth"; Patient's lips was swollen, Everything's still swollen, but nothing inside the mouth"; Patient's tongue was swollen, Everything's still swollen, but nothing inside the mouth"; This spontaneous case was reported by a consumer and describes the occurrence of SWELLING FACE (Swelling of face), EYE SWELLING (Patient's eyeswas swollen, Everything's still swollen, but nothing inside the mouth"), LIP SWELLING (Patient's lips was swollen, Everything's still swollen, but nothing inside the mouth"), SWOLLEN TONGUE (Patient's tongue was swollen, Everything's still swollen, but nothing inside the mouth") and CONDITION AGGRAVATED (patient got up and noticed the reaction was worse) in a 54-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 067F21A and 017F21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     Concurrent medical conditions included Seasonal allergy, Egg allergy and Hashimoto's disease. Concomitant products included LEVOTHYROXINE SODIUM (SYNTHROID) for Hashimoto's disease.   On 16-Oct-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 17-Nov-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 17-Nov-2021, the patient experienced SWELLING FACE (Swelling of face), EYE SWELLING (Patient's eyeswas swollen, Everything's still swollen, but nothing inside the mouth"), LIP SWELLING (Patient's lips was swollen, Everything's still swollen, but nothing inside the mouth"), SWOLLEN TONGUE (Patient's tongue was swollen, Everything's still swollen, but nothing inside the mouth") and URTICARIA (body was covered in hives/ Hives are slowly going away). On 18-Nov-2021, the patient experienced CONDITION AGGRAVATED (patient got up and noticed the reaction was worse). The patient was treated with DIPHENHYDRAMINE HYDROCHLORIDE (BENADRYL [DIPHENHYDRAMINE HYDROCHLORIDE]) at an unspecified dose and frequency. At the time of the report, SWELLING FACE (Swelling of face), EYE SWELLING (Patient's eyeswas swollen, Everything's still swollen, but nothing inside the mouth"), LIP SWELLING (Patient's lips was swollen, Everything's still swollen, but nothing inside the mouth") and SWOLLEN TONGUE (Patient's tongue was swollen, Everything's still swollen, but nothing inside the mouth") had not resolved, CONDITION AGGRAVATED (patient got up and noticed the reaction was worse) outcome was unknown and URTICARIA (body was covered in hives/ Hives are slowly going away) was resolving.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   This case was linked to MOD-2021-392454 (Patient Link).
Sex: U
Vaccine: COVID19
Symptoms: Expired product administered, Product administration error
Clinical narrative: error resulting in administration of expired vaccine; Expired vaccine used; Based on the current case data, this case has been classified as invalid. This spontaneous case was reported by a physician and describes the occurrence of PRODUCT ADMINISTRATION ERROR (error resulting in administration of expired vaccine) and 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. 026B21A) for COVID-19 vaccination.     No Medical History information was reported.    On 08-Oct-2021, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 08-Oct-2021, the patient experienced PRODUCT ADMINISTRATION ERROR (error resulting in administration of expired vaccine) and EXPIRED PRODUCT ADMINISTERED (Expired vaccine used). On 08-Oct-2021, PRODUCT ADMINISTRATION ERROR (error resulting in administration of expired vaccine) and 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 was provided by the reporter. N treatment was provided by the reporter.
Sex: U
Vaccine: COVID19
Symptoms: Expired product administered, Product administration error
Clinical narrative: error resulting in administration of expired vaccine; Expired vaccine used; Based on the current case data, this case has been classified as invalid. This spontaneous case was reported by a physician and describes the occurrence of PRODUCT ADMINISTRATION ERROR (error resulting in administration of expired vaccine) and 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. 003A21A) for COVID-19 vaccination.     No Medical History information was reported.    On 18-Oct-2021, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 18-Oct-2021, the patient experienced PRODUCT ADMINISTRATION ERROR (error resulting in administration of expired vaccine) and EXPIRED PRODUCT ADMINISTERED (Expired vaccine used). On 18-Oct-2021, PRODUCT ADMINISTRATION ERROR (error resulting in administration of expired vaccine) and 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 mediations were reported.
Sex: U
Vaccine: COVID19
Symptoms: Expired product administered, Product administration error
Clinical narrative: Error resulting in administration of expired vaccine; Expired vaccine used; Based on the current case data, this case has been classified as invalid. This spontaneous case was reported by a physician and describes the occurrence of PRODUCT ADMINISTRATION ERROR (Error resulting in administration of expired vaccine) and 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 11-Oct-2021, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 11-Oct-2021, the patient experienced PRODUCT ADMINISTRATION ERROR (Error resulting in administration of expired vaccine) and EXPIRED PRODUCT ADMINISTERED (Expired vaccine used). On 11-Oct-2021, PRODUCT ADMINISTRATION ERROR (Error resulting in administration of expired vaccine) and 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 medication was reported by reporter. No treatment medication was reported by reporter.
Age: 73.0
Sex: F
Vaccine: COVID19
Symptoms: Alopecia, Blood test, Chills, Pain in extremity, Pyrexia
Clinical narrative: Hair loss; Sore arm; Fever; Chills; This spontaneous case was reported by a consumer and describes the occurrence of ALOPECIA (Hair loss), PAIN IN EXTREMITY (Sore arm), PYREXIA (Fever) and CHILLS (Chills) in a 73-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 014F21A and 053E21A) for COVID-19 vaccination.     The patient's past medical history included COVID-19 (MAY 14-27 2021, went to hospital with COVID.) from 14-May-2021 to 27-May-2021. Concurrent medical conditions included Penicillin allergy, Contrast media allergy and Allergic reaction to analgesics (Demoral). Concomitant products included CALCIUM for Supplementation therapy.   On 18-Aug-2021 at 10:30 AM, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 18-Sep-2021 at 10:00 AM, 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 ALOPECIA (Hair loss), PAIN IN EXTREMITY (Sore arm), PYREXIA (Fever) and CHILLS (Chills). On 10-Nov-2021, ALOPECIA (Hair loss) had resolved. At the time of the report, PAIN IN EXTREMITY (Sore arm), PYREXIA (Fever) and CHILLS (Chills) had resolved.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): In 2021, Blood test: seems to be little off (abnormal) seems to be little off.         The onset time for events such as sore arm, fever and chills was provided as 10:00 pm.  No treatment medication were reported.   This case was linked to MOD-2021-304842 (Patient Link).
Sex: U
Vaccine: COVID19
Symptoms: Expired product administered
Clinical narrative: Expired vials were used to provide 38 doses; This spontaneous case was reported by an other health care professional and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Expired vials were used to provide 38 doses) in a  patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 049E21A) 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 vials were used to provide 38 doses). At the time of the report, EXPIRED PRODUCT ADMINISTERED (Expired vials were used to provide 38 doses) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   Concomitant product use was not provided by the reporter.  Treatment information was not provided.  Some of patient received booster dose on 1-Nov-2021, 05-Nov-2021, 11-Nov-2021 and 12-Nov-2021. No vial went any temperature excursions. On 12-NOV , all vaccines were administered within 2 hrs.  It was reported that, there are no adverse reactions to the vaccine.  This is a spontaneous case concerning a patient of unknown age and gender with no relevant medical history, who experienced the non serious event of expired product administered for mRNA-1273 vaccine with lot number 049E21A. The event expired product administered occurred right after the third dose of mRNA-1273 vaccine administration, the administered mRNA-1273 vaccine was 32 days past its manufacturer date of expiry (manufacturer date of expiry: 11 October 2021, date of mRNA-1273 vaccine administration: 12 November 2021). The benefit-risk relationship of mRNA-1273 vaccine is not affected by this report.   Most recent FOLLOW-UP information incorporated above includes: On 19-Nov-2021: Follow up received contains secondary reporter as non-significant information.; Sender's Comments: This is a spontaneous case concerning a patient of unknown age and gender with no relevant medical history, who experienced the non serious event of expired product administered for mRNA-1273 vaccine with lot number 049E21A. The event expired product administered occurred right after the third dose of mRNA-1273 vaccine administration, the administered mRNA-1273 vaccine was 32 days past its manufacturer date of expiry (manufacturer date of expiry: 11 October 2021, date of mRNA-1273 vaccine administration: 12 November 2021). The benefit-risk relationship of mRNA-1273 vaccine is not affected by this report.
Sex: U
Vaccine: COVID19
Symptoms: Expired product administered
Clinical narrative: expired vials were used to provide 38 doses; This spontaneous case was reported by an other health care professional and describes the occurrence of PAIN IN EXTREMITY (Sore arm), VACCINATION COMPLICATION (some identified common side effects after the vaccine (ex: sore arm, etc.)) and EXPIRED PRODUCT ADMINISTERED (expired vials were used to provide 38 doses) in a  patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 049E21A) for COVID-19 vaccination.     No Medical History information was reported.    On 05-Nov-2021, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 05-Nov-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (expired vials were used to provide 38 doses). In November 2021, the patient experienced PAIN IN EXTREMITY (Sore arm) and VACCINATION COMPLICATION (some identified common side effects after the vaccine (ex: sore arm, etc.)). On 05-Nov-2021, EXPIRED PRODUCT ADMINISTERED (expired vials were used to provide 38 doses) had resolved. In November 2021, PAIN IN EXTREMITY (Sore arm) and VACCINATION COMPLICATION (some identified common side effects after the vaccine (ex: sore arm, etc.)) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   Concomitant product use was not provided by the reporter.  No vial went any temperature excursions.  Some of patient received booster dose on 1-Nov-2021, 05-Nov-2021, 11-Nov-2021 and 12-Nov-2021. Till 19-Nov-2021, there were no adverse reactions to the vaccine.  As of 19 Nov 2021, there were no adverse reactions to the vaccine reported by the list below. We spoke with some that received the vaccine during these dates and some identified common side effects after the vaccine (ex: sore arm, etc.) and only lasted for a few hours but no more than 24 hours for 1st dose, 2nd dose and Booster.  Treatment information was not provided.    Most recent FOLLOW-UP information incorporated above includes: On 18-Nov-2021: The additional information included suspect administration date. On 19-Nov-2021: Follow-up information included about patients details On 19-Nov-2021: Significant FU appended (Second reporter Information was updated)
Sex: U
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 patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 049E21A) for COVID-19 vaccination.     No Medical History information was reported.    On 11-Nov-2021, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 11-Nov-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (Expired vaccine used). On 11-Nov-2021, EXPIRED PRODUCT ADMINISTERED (Expired vaccine used) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown Route), the reporter did not provide any causality assessments.   No concomitant medication was reported. No treatment information was provided.  No vial went any temperature excursions.  there was no adverse reactions to the patient   Most recent FOLLOW-UP information incorporated above includes: On 19-Nov-2021: Follow up added second reporter details
Sex: U
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  patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 049E21A) 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.   Concomitant product use was not provided by the reporter. Treatment information was not provided.  No vial went any temperature excursions.   Most recent FOLLOW-UP information incorporated above includes: On 19-Nov-2021: Follow up received added second reporter information
Sex: U
Vaccine: COVID19
Symptoms: Expired product administered
Clinical narrative: expired vials were used to provide 38 doses of of the Moderna Covid-19 Vaccine.; This spontaneous case was reported by an other health care professional and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (expired vials were used to provide 38 doses of of the Moderna Covid-19 Vaccine.) in a  patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 049E21A) 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 vials were used to provide 38 doses of of the Moderna Covid-19 Vaccine.). On 12-Nov-2021, EXPIRED PRODUCT ADMINISTERED (expired vials were used to provide 38 doses of of the Moderna Covid-19 Vaccine.) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   Concomitant product use was not provided by the reporter.  Treatment information was not provided.  No vial had undergone any temperature excursions. There were no adverse reactions to the vaccine as reported by the patient. Reported some that received the vaccine during dates given and some identified common side effects after the vaccine (ex: sore arm, etc.) and only lasted for a few hours but no more than 24 hours for 1st dose, 2nd dose and Booster.   Most recent FOLLOW-UP information incorporated above includes: On 19-Nov-2021: Follow up received contains Non significant information. Added: secondary reporter details.
Sex: F
Vaccine: COVID19
Symptoms: Influenza
Clinical narrative: Flu symptoms for a coupe of days after they got the booster dose of the Moderna Covid-19 vaccine; This spontaneous case was reported by a consumer and describes the occurrence of INFLUENZA (Flu symptoms for a coupe of days after they got the booster dose of the Moderna Covid-19 vaccine) 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 19-Nov-2021, the patient experienced INFLUENZA (Flu symptoms for a coupe of days after they got the booster dose of the Moderna Covid-19 vaccine). At the time of the report, INFLUENZA (Flu symptoms for a coupe of days after they got the booster dose of the Moderna Covid-19 vaccine) outcome was unknown.            Concomitant medications details were not reported by the reporter.  Treatment details was not reported by the reporter.
Sex: M
Vaccine: COVID19
Symptoms: Influenza
Clinical narrative: flu symptoms for a coupe of days after they got the booster dose of the Moderna Covid-19 vaccine; This spontaneous case was reported by a consumer and describes the occurrence of INFLUENZA (flu symptoms for a coupe of days after they got the booster dose of the Moderna Covid-19 vaccine) in a male patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On an unknown date, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 19-Nov-2021, the patient experienced INFLUENZA (flu symptoms for a coupe of days after they got the booster dose of the Moderna Covid-19 vaccine). In November 2021, INFLUENZA (flu symptoms for a coupe of days after they got the booster dose of the Moderna Covid-19 vaccine) had resolved.            Concomitant medication information was not provided by the reporter.  Treatment information was not provided by the reporter.; Sender's Comments: Non-serious case.
Age: 72.0
Sex: F
Vaccine: COVID19
Symptoms: Contusion, Immune thrombocytopenia, Mouth ulceration, Platelet count
Clinical narrative: severe immune thrombocytopenia; ulcers inside the mouth bleeding; bruises on arms and legs; This spontaneous case was reported by a consumer and describes the occurrence of IMMUNE THROMBOCYTOPENIA (severe immune thrombocytopenia) in a 72-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.    On 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 IMMUNE THROMBOCYTOPENIA (severe immune thrombocytopenia) (seriousness criteria hospitalization and medically significant), MOUTH ULCERATION (ulcers inside the mouth bleeding) and CONTUSION (bruises on arms and legs). The patient was hospitalized on 19-Jan-2021 due to IMMUNE THROMBOCYTOPENIA. At the time of the report, IMMUNE THROMBOCYTOPENIA (severe immune thrombocytopenia), MOUTH ULCERATION (ulcers inside the mouth bleeding) and CONTUSION (bruises on arms and legs) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 01-Feb-2021, Platelet count: 71000 (Low) Decreased. On an unknown date, Platelet count: 6000 (Low) Decreased and 40000 (Low) Decreased.     The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No concomitant medications were provided. Treatment for the events were not provided.  Company Comment: This spontaneous case concerns a 72-year-old female patient with no relevant medical history who experienced serious unexpected event of thrombocytopenia. The event occurred unspecified time after the unspecified dose of the Moderna COVID-19 vaccine .  Rechallenge was not applicable since due to unknown outcome and lack of information on the second dose, no rechallenge was done and recurrence was not applicable.  The benefit-risk relationship of drug is not affected by this report.; Sender's Comments: This spontaneous case concerns a 72-year-old female patient with no relevant medical history who experienced serious unexpected event of thrombocytopenia. The event occurred unspecified time after the unspecified dose of the Moderna COVID-19 vaccine .  Rechallenge was not applicable since due to unknown outcome and lack of information on the second dose, no rechallenge was done and recurrence was not applicable.  The benefit-risk relationship of drug is not affected by this report.
Age: 61.0
Sex: F
Vaccine: COVID19
Symptoms: Chills, Pain, Pyrexia
Clinical narrative: Body aches; Fever; Chills; This spontaneous case was reported by a consumer and describes the occurrence of PAIN (Body aches), PYREXIA (Fever) and CHILLS (Chills) in a 61-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 011A21A and 012M20A) 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) (Intramuscular) 1 dosage form. On 03-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. In March 2021, the patient experienced PAIN (Body aches), PYREXIA (Fever) and CHILLS (Chills). In March 2021, PAIN (Body aches), PYREXIA (Fever) and CHILLS (Chills) had resolved.            No concomitant medications were reported. No treatment medications were reported.   This case was linked to MOD-2021-393289, MOD-2021-393303 (Patient Link).
Sex: F
Vaccine: COVID19
Symptoms: Headache, Lethargy, Oropharyngeal pain
Clinical narrative: sore throat; was kind of lethargic; headache; This spontaneous case was reported by a consumer and describes the occurrence of OROPHARYNGEAL PAIN (sore throat), LETHARGY (was kind of lethargic) and HEADACHE (headache) 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 OROPHARYNGEAL PAIN (sore throat), LETHARGY (was kind of lethargic) and HEADACHE (headache). At the time of the report, OROPHARYNGEAL PAIN (sore throat), LETHARGY (was kind of lethargic) and HEADACHE (headache) outcome was unknown.            Concomitant medication information was not reported  Treatment information was not reported
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 information was reported.    On 04-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced PAIN IN EXTREMITY (sore arm). At the time of the report, PAIN IN EXTREMITY (sore arm) outcome was unknown.        mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosing remained unchanged.       Concomitant product use was not provided by the reporter.  No treatment information was provided.   This case was linked to MOD-2021-393453, MOD-2021-393454 (Patient Link).
Age: 95.0
Sex: M
Vaccine: COVID19
Symptoms: Chills, Feeling abnormal
Clinical narrative: Feels like going to bed and cover up; Chills; This spontaneous case was reported by a consumer and describes the occurrence of FEELING ABNORMAL (Feels like going to bed and cover up) and CHILLS (Chills) in a 95-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 069F21A, 029L20A and 031M20A) for COVID-19 vaccination.     No Medical History information was reported.   On 27-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 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 18-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 FEELING ABNORMAL (Feels like going to bed and cover up) and CHILLS (Chills). At the time of the report, FEELING ABNORMAL (Feels like going to bed and cover up) and CHILLS (Chills) outcome was unknown.            No concomitant and treatment information were reported by the reporter  It was reported that patient had not called the doctor / nurse. Patient had not taken any medicine yet.
Age: 53.0
Sex: F
Vaccine: COVID19
Symptoms: Fatigue, Nausea
Clinical narrative: tired after the first vaccine; naueseous after the first vaccine; This spontaneous case was reported by a consumer and describes the occurrence of FATIGUE (tired after the first vaccine) and NAUSEA (naueseous after the first vaccine) in a 53-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 011F21A) for COVID-19 vaccination.     No Medical History information was reported.    On 16-Oct-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 16-Oct-2021, the patient experienced FATIGUE (tired after the first vaccine) and NAUSEA (naueseous after the first vaccine). At the time of the report, FATIGUE (tired after the first vaccine) and NAUSEA (naueseous after the first vaccine) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No concomitant medication were reported. No treatment information was provided by the reporter.  Patient was tired and nauseous for a few hours after the first Moderna Covid-19 vaccine.
Sex: U
Vaccine: COVID19
Symptoms: Expired product administered
Clinical narrative: expired vials were used to provide 38 doses; This spontaneous case was reported by an other health care professional and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (expired vials were used to provide 38 doses) in a  patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 049E21A) for COVID-19 vaccination.     No Medical History information was reported.    On 12-Nov-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 12-Nov-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (expired vials were used to provide 38 doses). On 12-Nov-2021, EXPIRED PRODUCT ADMINISTERED (expired vials were used to provide 38 doses) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant medication was provided.  No treatment medication was reported.   No vial went any temperature excursions and it was reported that, there were no adverse reactions to the vaccine.  Company comment- This is a spontaneous case concerning a patient of unknown age and gender with no relevant medical history, who experienced the non serious event of expired product administered for mRNA-1273 vaccine with lot number 049E21A. The event expired product administered occurred right after the first dose of mRNA-1273 vaccine administration, the administered mRNA-1273 vaccine was 32 days past its manufacturer date of expiry (manufacturer date of expiry: 11 October 2021, date of mRNA-1273 vaccine administration: 12 November 2021). The benefit-risk relationship of mRNA-1273 vaccine is not affected by this report.   Most recent FOLLOW-UP information incorporated above includes: On 19-Nov-2021: Follow Up was received contains non significant information, added secondary reporter details.; Sender's Comments: This is a spontaneous case concerning a patient of unknown age and gender with no relevant medical history, who experienced the non serious event of expired product administered for mRNA-1273 vaccine with lot number 049E21A. The event expired product administered occurred right after the first dose of mRNA-1273 vaccine administration, the administered mRNA-1273 vaccine was 32 days past its manufacturer date of expiry (manufacturer date of expiry: 11 October 2021, date of mRNA-1273 vaccine administration: 12 November 2021). The benefit-risk relationship of mRNA-1273 vaccine is not affected by this report.
Age: 42.0
Sex: M
Vaccine: COVID19
Symptoms: Amnesia, Anal incontinence, Deafness unilateral, Headache, Mobility decreased
Clinical narrative: "Stabbing" headaches, progressive memory loss, unexplained uncontrollable swelling below the waist, loss of bowel & bladder control, deaf in right ear, blind spot in left eye, could no longer perform basic movements independently.
Age: 42.0
Sex: M
Vaccine: COVID19
Symptoms: Swelling, Urinary incontinence, Visual field defect
Clinical narrative: "Stabbing" headaches, progressive memory loss, unexplained uncontrollable swelling below the waist, loss of bowel & bladder control, deaf in right ear, blind spot in left eye, could no longer perform basic movements independently.
Age: 12.0
Sex: F
Vaccine: HPV9
Symptoms: Chills, Headache, Syncope
Clinical narrative: Chills,headache , syncope
Age: 46.0
Sex: F
Vaccine: COVID19
Symptoms: Swelling face
Clinical narrative: Left side of face swollen
Age: 38.0
Sex: F
Vaccine: COVID19
Symptoms: Erythema, Induration, Peripheral swelling, Pruritus
Clinical narrative: Arm has swelled, very red, moved to arm out, itchy, hard spot underneath skin
Age: 31.0
Sex: M
Vaccine: COVID19
Symptoms: Hypoaesthesia, Sleep disorder
Clinical narrative: Every night since the vaccine,  my hands go numb in the middle of the night and some times throughout the day. This wakes me up every night and I have to flex my hands for a few minutes to regain feeling. I've noticed that this happens regardless of my sleeping position and hand placement.   I have yet to be seen for these symptoms.
Sex: U
Vaccine: COVID19
Symptoms: Expired product administered
Clinical narrative: Expired vaccine used; 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 (Expired vaccine used) in a  patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 047C21A) for COVID-19 vaccination.     No Medical History information was reported.    On 09-Nov-2021, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) .25 milliliter. On 09-Nov-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (Expired vaccine used). On 09-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 medication was reported.  No treatment medication use was reported.  The vaccine was stored in 21 Oct 2021. 13 patients were administered. The vial did not undergo any temperature excursions.   Most recent FOLLOW-UP information incorporated above includes: On 19-Nov-2021: Follow-up received stated that the patient experienced no adverse event.
Sex: U
Vaccine: COVID19
Symptoms: Influenza like illness, Vaccination complication
Clinical narrative: the vaccine made them "sick as hell,"; like they had the flu for 3 days; Based on the current case data, this case has been classified as invalid. This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION COMPLICATION (the vaccine made them "sick as hell,") and INFLUENZA LIKE ILLNESS (like they had the flu for 3 days) in a  patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On an unknown date, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced VACCINATION COMPLICATION (the vaccine made them "sick as hell,") and INFLUENZA LIKE ILLNESS (like they had the flu for 3 days). At the time of the report, VACCINATION COMPLICATION (the vaccine made them "sick as hell,") outcome was unknown and INFLUENZA LIKE ILLNESS (like they had the flu for 3 days) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No Concomitant drug reported. No Treatment drug reported.
Age: 48.0
Sex: M
Vaccine: COVID19
Symptoms: Herpes zoster, Rash pruritic, Urticaria
Clinical narrative: welts, really itchy, like hives or bumps/behind their knee; shingles; rash was itchy and affected the left side of the stomach, and under the arm; This spontaneous case was reported by a consumer and describes the occurrence of HERPES ZOSTER (shingles), RASH PRURITIC (rash was itchy and affected the left side of the stomach, and under the arm) and URTICARIA (welts, really itchy, like hives or bumps/behind their knee) in a 48-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 010A21A and 028(L or Z?)20A) for COVID-19 vaccination.     Concurrent medical conditions included Drug addiction. Concomitant products included BUPRENORPHINE HYDROCHLORIDE, NALOXONE HYDROCHLORIDE (SUBOXONE) for Drug addiction.   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. In March 2021, the patient experienced HERPES ZOSTER (shingles) and RASH PRURITIC (rash was itchy and affected the left side of the stomach, and under the arm). On an unknown date, the patient experienced URTICARIA (welts, really itchy, like hives or bumps/behind their knee). The patient was treated with GABAPENTIN for Shingles, at an unspecified dose and frequency. At the time of the report, HERPES ZOSTER (shingles) outcome was unknown and RASH PRURITIC (rash was itchy and affected the left side of the stomach, and under the arm) and URTICARIA (welts, really itchy, like hives or bumps/behind their knee) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   Patient took antiviral medication for the shingles and change body soap and will try antihistamine medications.   This case was linked to MOD-2021-390735 (Patient Link).