chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 88.0
Sex: F
Vaccine: COVID19
Symptoms: Accidental underdose
Clinical narrative: a patient received a 0.25CC dose of Moderna Covid19 Vaccine as a first dose instead of a 0.5CC dose.; This spontaneous case was reported by a nurse and describes the occurrence of ACCIDENTAL UNDERDOSE (a patient received a 0.25CC dose of Moderna Covid19 Vaccine as a first dose instead of a 0.5CC dose.) in an 88-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 005C21A) for COVID-19 vaccination.     No Medical History information was reported.    On 18-Nov-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 18-Nov-2021, the patient experienced ACCIDENTAL UNDERDOSE (a patient received a 0.25CC dose of Moderna Covid19 Vaccine as a first dose instead of a 0.5CC dose.). On 18-Nov-2021, ACCIDENTAL UNDERDOSE (a patient received a 0.25CC dose of Moderna Covid19 Vaccine as a first dose instead of a 0.5CC dose.) had resolved.        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.   No concomitant drug details were reported. No treatment details were reported.; Sender's Comments: Non-serious Case
Age: 67.0
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 67-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.   On 24-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 27-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 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) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   Patient had a sore arm lasting 2-3 days. No relevant concomitant medications were reported. Treatment medication was not provided by the reporter.   This case was linked to MOD-2021-392249, MOD-2021-392282 (Patient Link).
Age: 67.0
Sex: F
Vaccine: COVID19
Symptoms: Expired product administered, Pain in extremity
Clinical narrative: Expired vaccine used; sore arm; This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (sore arm) and EXPIRED PRODUCT ADMINISTERED (Expired vaccine used) in a 67-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.   On 24-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 27-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 26-Oct-2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 26-Oct-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (Expired vaccine used). On an unknown date, the patient experienced PAIN IN EXTREMITY (sore arm). On 26-Oct-2021, EXPIRED PRODUCT ADMINISTERED (Expired vaccine used) had resolved. At the time of the report, PAIN IN EXTREMITY (sore arm) had resolved.            No concomitant medications were reported. No treatment medications were reported. This is a case of Expired Product Administered concerning a 67-year-old female patient with no relevant medical history, who experienced the unexpected adverse event of Pain in Extremity. The event occurred approximately the same time after receiving the third dose of mRNA-1273 Vaccine. The rechallenge is positive for dose 2 and dose 3 since the event Pain Extremity happened on all 3 doses and resolving about 2-3 days however rechallenge for dose 1 and dose 2 is negative it was mentioned that in the first dose patient took treatment. The benefit-risk relationship of mRNA-1273 Vaccine is not affected by this report.   This case was linked to MOD-2021-392249, MOD-2021-392275 (Patient Link).; Sender's Comments: This is a case of Expired Product Administered concerning a 67-year-old female patient with no relevant medical history, who experienced the unexpected adverse event of Pain in Extremity. The event occurred approximately the same time after receiving the third dose of mRNA-1273 Vaccine. The rechallenge is positive for dose 2 and dose 3 since the event Pain Extremity happened on all 3 doses and resolving about 2-3 days however rechallenge for dose 1 and dose 2 is negative it was mentioned that in the first dose patient took treatment. The benefit-risk relationship of mRNA-1273 Vaccine is not affected by this report.
Age: 42.0
Sex: F
Vaccine: COVID19
Symptoms: Back pain, Blood test, Chromaturia, Fatigue, Pain
Clinical narrative: Booster- severe back pain; little achy; tired; some injection site pain; urine was dark, like cola colored- urinalysis showed blood and protein in urine.; This spontaneous case was reported by a consumer and describes the occurrence of CHROMATURIA (urine was dark, like cola colored- urinalysis showed blood and protein in urine.), BACK PAIN (Booster- severe back pain), PAIN (little achy), FATIGUE (tired) and VACCINATION SITE PAIN (some injection site pain) in a 42-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 069F21A, 003B21A and 010M21A) for COVID-19 vaccination.     No relevant medical history provided.    On 28-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 28-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 14-Nov-2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 16-Nov-2021, the patient experienced CHROMATURIA (urine was dark, like cola colored- urinalysis showed blood and protein in urine.). On an unknown date, the patient experienced BACK PAIN (Booster- severe back pain), PAIN (little achy), FATIGUE (tired) and VACCINATION SITE PAIN (some injection site pain). The patient was treated with IBUPROFEN ongoing since an unknown date for Back pain, at an unspecified dose and frequency and PARACETAMOL (TYLENOL [PARACETAMOL]) ongoing since an unknown date for Back pain, at an unspecified dose and frequency. At the time of the report, CHROMATURIA (urine was dark, like cola colored- urinalysis showed blood and protein in urine.), BACK PAIN (Booster- severe back pain), PAIN (little achy), FATIGUE (tired) and VACCINATION SITE PAIN (some injection site pain) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 16-Nov-2021, Urine analysis: normal (normal) urine was dark (like cola color).blood and protein in urine. There were no signs of infections.. On an unknown date, Blood test: normal (normal) results indicated elevated signs on in inflammation.         Concomitant medications were not provided   This case was linked to MOD-2021-392177 (Patient Link).
Age: 42.0
Sex: F
Vaccine: COVID19
Symptoms: Urine analysis, Vaccination site pain
Clinical narrative: Booster- severe back pain; little achy; tired; some injection site pain; urine was dark, like cola colored- urinalysis showed blood and protein in urine.; This spontaneous case was reported by a consumer and describes the occurrence of CHROMATURIA (urine was dark, like cola colored- urinalysis showed blood and protein in urine.), BACK PAIN (Booster- severe back pain), PAIN (little achy), FATIGUE (tired) and VACCINATION SITE PAIN (some injection site pain) in a 42-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 069F21A, 003B21A and 010M21A) for COVID-19 vaccination.     No relevant medical history provided.    On 28-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 28-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 14-Nov-2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 16-Nov-2021, the patient experienced CHROMATURIA (urine was dark, like cola colored- urinalysis showed blood and protein in urine.). On an unknown date, the patient experienced BACK PAIN (Booster- severe back pain), PAIN (little achy), FATIGUE (tired) and VACCINATION SITE PAIN (some injection site pain). The patient was treated with IBUPROFEN ongoing since an unknown date for Back pain, at an unspecified dose and frequency and PARACETAMOL (TYLENOL [PARACETAMOL]) ongoing since an unknown date for Back pain, at an unspecified dose and frequency. At the time of the report, CHROMATURIA (urine was dark, like cola colored- urinalysis showed blood and protein in urine.), BACK PAIN (Booster- severe back pain), PAIN (little achy), FATIGUE (tired) and VACCINATION SITE PAIN (some injection site pain) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 16-Nov-2021, Urine analysis: normal (normal) urine was dark (like cola color).blood and protein in urine. There were no signs of infections.. On an unknown date, Blood test: normal (normal) results indicated elevated signs on in inflammation.         Concomitant medications were not provided   This case was linked to MOD-2021-392177 (Patient Link).
Age: 63.0
Sex: F
Vaccine: COVID19
Symptoms: Product use issue
Clinical narrative: received a booster dose of Moderna vial after vial had been punctured 20 times already; This spontaneous case was reported by a nurse and describes the occurrence of PRODUCT USE ISSUE (received a booster dose of Moderna vial after vial had been punctured 20 times already) in a 63-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 032F21A) for COVID-19 vaccination.     No Medical History information was reported.    On 10-Nov-2021 at 4:00 PM, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 10-Nov-2021, the patient experienced PRODUCT USE ISSUE (received a booster dose of Moderna vial after vial had been punctured 20 times already). On 10-Nov-2021, PRODUCT USE ISSUE (received a booster dose of Moderna vial after vial had been punctured 20 times already) had resolved. Not Provided      For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant medication information was provided. No treatment medication information was provided.  Patient received a Moderna Booster on 11/10/21 from a vial where 20 punctures had already occurred. The right vaccine was given to the right patient at the right time with the right dose.   This case was linked to MOD-2021-392366 (Patient Link).
Age: 35.0
Sex: M
Vaccine: COVID19
Symptoms: Accidental underdose
Clinical narrative: received a dose of Moderna vial after vial had been punctured 20 times already; This spontaneous case was reported by a nurse and describes the occurrence of ACCIDENTAL UNDERDOSE (received a dose of Moderna vial after vial had been punctured 20 times already) in a 35-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 032F21A) for COVID-19 vaccination.     No Medical History information was reported.    On 11-Oct-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 11-Oct-2021, the patient experienced ACCIDENTAL UNDERDOSE (received a dose of Moderna vial after vial had been punctured 20 times already). At the time of the report, ACCIDENTAL UNDERDOSE (received a dose of Moderna vial after vial had been punctured 20 times already) outcome was unknown. Not Provided      For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter considered ACCIDENTAL UNDERDOSE (received a dose of Moderna vial after vial had been punctured 20 times already) to be not related.    There are no treatment or concomitant medications provided.   This case was linked to MOD-2021-392366 (Patient Link).
Sex: U
Vaccine: COVID19
Symptoms: Expired product administered
Clinical narrative: error resulting in administration of expired vaccine; This spontaneous case was reported by a physician and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (error resulting in administration of expired vaccine) 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 dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 08-Oct-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (error resulting in administration of expired vaccine). On 08-Oct-2021, EXPIRED PRODUCT ADMINISTERED (error resulting in administration of expired vaccine) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   Company Comment-This spontaneous case concerns a patient with no relevant medical history who experienced the unexpected event of expired product administered. Rechallenge was not applicable since due to nature of the event, no rechallenge was done and thus, recurrence was not applicable.  The benefit-risk relationship of product is not affected by this report  No concomitant medication were reported.  No treatment information was reported.     This case was linked to MOD-2021-395523 (Patient Link).   Most recent FOLLOW-UP information incorporated above includes: On 22-Nov-2021: Follow up received contains significant information Added: updated patient details.; Sender's Comments: This spontaneous case concerns a patient with no relevant medical history who experienced the unexpected event of expired product administered. Rechallenge was not applicable since due to nature of the event, no rechallenge was done and thus, recurrence was not applicable.  The benefit-risk relationship of product is not affected by this report
Sex: F
Vaccine: COVID19
Symptoms: Device connection issue, Underdose
Clinical narrative: The syringe came apart; Some of the dose dripped down; This spontaneous case was reported by a consumer and describes the occurrence of DEVICE CONNECTION ISSUE (The syringe came apart) and UNDERDOSE (Some of the dose dripped down) 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 18-Nov-2021, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 18-Nov-2021, the patient experienced DEVICE CONNECTION ISSUE (The syringe came apart) and UNDERDOSE (Some of the dose dripped down). On 18-Nov-2021, DEVICE CONNECTION ISSUE (The syringe came apart) and UNDERDOSE (Some of the dose dripped down) had resolved.      No concomitant and treatment information were reported by the reporter.  Patient got the booster dose yesterday. And while the pharmacist was administering the vaccine, the syringe came apart and some of it dripped down.   Reporter did not allow further contact
Sex: U
Vaccine: COVID19
Symptoms: Expired product administered
Clinical narrative: error resulting in administration of expired vaccine; 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 EXPIRED PRODUCT ADMINISTERED (error resulting in administration of expired vaccine) 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 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 EXPIRED PRODUCT ADMINISTERED (error resulting in administration of expired vaccine). On 11-Oct-2021, EXPIRED PRODUCT ADMINISTERED (error resulting in administration of expired vaccine) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant medication were provided. No  treatment details were provided.
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 15-Oct-2021, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 15-Oct-2021, the patient experienced PRODUCT ADMINISTRATION ERROR (Error resulting in administration of expired vaccine) and EXPIRED PRODUCT ADMINISTERED (Expired vaccine used). On 15-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 medications were reported.
Age: 72.0
Sex: M
Vaccine: COVID19
Symptoms: Expired product administered
Clinical narrative: Expired vaccine used; This spontaneous case was reported by a pharmacist and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Expired vaccine used) in a 72-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 049E21A,) for COVID-19 vaccination.     No Medical History information was reported.    On 24-Oct-2021, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 24-Oct-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (Expired vaccine used). On 24-Oct-2021, EXPIRED PRODUCT ADMINISTERED (Expired vaccine used) had resolved. Not Provided      For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   No concomitants and treatment medications reported.   This case was linked to MOD-2021-363223 (Patient Link).   Reporter did not allow further contact
Sex: U
Vaccine: COVID19
Symptoms: Expired product administered
Clinical narrative: Expired vaccine given to patients; Based on the current case data, this case has been classified as invalid. This spontaneous case was reported by an other health care professional and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Expired vaccine given to patients) in a  patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On an unknown date, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced EXPIRED PRODUCT ADMINISTERED (Expired vaccine given to patients). At the time of the report, EXPIRED PRODUCT ADMINISTERED (Expired vaccine given to patients) had resolved. Not Provided      For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant medication reported. No treatment medication reported.  Non-serious case.   Most recent FOLLOW-UP information incorporated above includes: On 19-Nov-2021: Follow-up received contains no new information.; Sender's Comments: Non-serious case.
Age: 83.0
Sex: F
Vaccine: COVID19
Symptoms: Chills, Dizziness, Feeling cold, Headache, Influenza like illness
Clinical narrative: Lightheaded; not feeling good; was freezing cold; couldn't even raise her arm; she felt like she had the cold; Shivering; Headache; This spontaneous case was reported by a consumer and describes the occurrence of DIZZINESS (Lightheaded), MALAISE (not feeling good), FEELING COLD (was freezing cold), MOBILITY DECREASED (couldn't even raise her arm) and INFLUENZA LIKE ILLNESS (she felt like she had the cold) in an 83-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 16-Nov-2021, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 16-Nov-2021, the patient experienced DIZZINESS (Lightheaded), MALAISE (not feeling good), FEELING COLD (was freezing cold), MOBILITY DECREASED (couldn't even raise her arm), INFLUENZA LIKE ILLNESS (she felt like she had the cold), CHILLS (Shivering) and HEADACHE (Headache). On 17-Nov-2021, DIZZINESS (Lightheaded), MALAISE (not feeling good), FEELING COLD (was freezing cold), MOBILITY DECREASED (couldn't even raise her arm), INFLUENZA LIKE ILLNESS (she felt like she had the cold), CHILLS (Shivering) and HEADACHE (Headache) had resolved.            No concomitant medications were reported. No treatment medications were reported.   This case was linked to MOD-2021-393117, MOD-2021-392965 (Patient Link).   Most recent FOLLOW-UP information incorporated above includes: On 24-Nov-2021: Reporter's details was updated. Non-Significant Follow up was received
Age: 83.0
Sex: F
Vaccine: COVID19
Symptoms: Malaise, Mobility decreased
Clinical narrative: Lightheaded; not feeling good; was freezing cold; couldn't even raise her arm; she felt like she had the cold; Shivering; Headache; This spontaneous case was reported by a consumer and describes the occurrence of DIZZINESS (Lightheaded), MALAISE (not feeling good), FEELING COLD (was freezing cold), MOBILITY DECREASED (couldn't even raise her arm) and INFLUENZA LIKE ILLNESS (she felt like she had the cold) in an 83-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 16-Nov-2021, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 16-Nov-2021, the patient experienced DIZZINESS (Lightheaded), MALAISE (not feeling good), FEELING COLD (was freezing cold), MOBILITY DECREASED (couldn't even raise her arm), INFLUENZA LIKE ILLNESS (she felt like she had the cold), CHILLS (Shivering) and HEADACHE (Headache). On 17-Nov-2021, DIZZINESS (Lightheaded), MALAISE (not feeling good), FEELING COLD (was freezing cold), MOBILITY DECREASED (couldn't even raise her arm), INFLUENZA LIKE ILLNESS (she felt like she had the cold), CHILLS (Shivering) and HEADACHE (Headache) had resolved.            No concomitant medications were reported. No treatment medications were reported.   This case was linked to MOD-2021-393117, MOD-2021-392965 (Patient Link).   Most recent FOLLOW-UP information incorporated above includes: On 24-Nov-2021: Reporter's details was updated. Non-Significant Follow up was received
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.  Some of patient received booster dose on 1-Nov-2021, 05-Nov-2021, 11-Nov-2021 and 12-Nov-2021.  vaccine expiration date was 11-OCT-2021.  No vial went any temperature excursions. vaccine  was administered within 2 hrs.   No adverse reactions to the vaccine reported.   Most recent FOLLOW-UP information incorporated above includes: On 19-Nov-2021: Non Significant FU : Secondary reporter Information is updated.
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) dosage was changed to 1 dosage form. On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 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.   Concomitant product use was not provided by the reporter.  No vial went any temperature excursions.  On 12-Nov-2021, all vaccines were administered within 2 hours.  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 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 vaccine used). On 05-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 information was reported. No treatment medications were provided.  No vial went any temperature excursions. There are no adverse reactions to the vaccine reported.   Most recent FOLLOW-UP information incorporated above includes: On 19-Nov-2021: Follow-up received contains non-significant information- Added second reporter.
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 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 vaccine used). On 05-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 provided.  No treatment medications were provided.  No vial went any temperature excursions.   Most recent FOLLOW-UP information incorporated above includes: On 19-Nov-2021: Follow Up Appended (Second reporter Information)
Sex: U
Vaccine: COVID19
Symptoms: Expired product administered
Clinical narrative: expired vaccine administered; This spontaneous case was reported by an other health care professional and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (expired vaccine administered) 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 vaccine administered). On 05-Nov-2021, EXPIRED PRODUCT ADMINISTERED (expired vaccine administered) 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.   Most recent FOLLOW-UP information incorporated above includes: On 19-Nov-2021: Follow up added new reporter information
Sex: U
Vaccine: COVID19
Symptoms: Expired product administered
Clinical narrative: Expired vials were used; This spontaneous case was reported by an other health care professional and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Expired vials were 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 vials were used). On 12-Nov-2021, EXPIRED PRODUCT ADMINISTERED (Expired vials were used) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant medications were provided. No treatment medications were reported.  No vial had undergone any temperature excursions. There were no adverse reactions to the vaccine as reported by the patient.   Most recent FOLLOW-UP information incorporated above includes: On 19-Nov-2021: Follow up received on 19-Nov-21, included secondary 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.  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. It was reported that, there are no adverse reactions to the vaccine.   Most recent FOLLOW-UP information incorporated above includes: On 19-Nov-2021: Follow up document contains non significant information, Second reporter Information added.
Sex: M
Vaccine: COVID19
Symptoms: Dizziness, Limb discomfort, Muscular weakness, Vaccination site pain
Clinical narrative: Dizziness; Was having problems with the legs; Legs got really weak; Sore on the arm; This spontaneous case was reported by a consumer and describes the occurrence of DIZZINESS (Dizziness), LIMB DISCOMFORT (Was having problems with the legs), MUSCULAR WEAKNESS (Legs got really weak) and VACCINATION SITE PAIN (Sore on the arm) 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 April 2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. In April 2021, the patient experienced DIZZINESS (Dizziness), LIMB DISCOMFORT (Was having problems with the legs), MUSCULAR WEAKNESS (Legs got really weak) and VACCINATION SITE PAIN (Sore on the arm). In April 2021, DIZZINESS (Dizziness) and VACCINATION SITE PAIN (Sore on the arm) had resolved. At the time of the report, LIMB DISCOMFORT (Was having problems with the legs) and MUSCULAR WEAKNESS (Legs got really weak) outcome was unknown.        mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) dosing remained unchanged.       No concomitant medications were reported. No treatment medications were reported.  Patient had dizziness and sore on the arm with the first dose but not too bad, it went away after 2 days. Patient noticed that legs had got really weak. Patient could walk but was having problems with the legs.   This case was linked to MOD-2021-393296 (Patient Link).
Age: 61.0
Sex: F
Vaccine: COVID19
Symptoms: Fatigue
Clinical narrative: This spontaneous case was reported by a consumer and describes the occurrence of FATIGUE (Tired) in a 60-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 012M20A) for COVID-19 vaccination. No Medical History information was reported. On 02-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. In February 2021, the patient experienced FATIGUE (Tired). At the time of the report, FATIGUE (Tired) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No relevant concomitant medications were reported. Treatment medication was not provided by the reporter.   This case was linked to MOD-2021-393302, MOD-2021-393303 (Patient Link).
Sex: M
Vaccine: COVID19
Symptoms: Limb discomfort, Muscular weakness
Clinical narrative: was having problems with the legs; legs got really weak; This spontaneous case was reported by a consumer and describes the occurrence of LIMB DISCOMFORT (was having problems with the legs) and MUSCULAR WEAKNESS (legs got really weak) 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 April 2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 04-May-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. In 2021, the patient experienced LIMB DISCOMFORT (was having problems with the legs) and MUSCULAR WEAKNESS (legs got really weak). At the time of the report, LIMB DISCOMFORT (was having problems with the legs) and MUSCULAR WEAKNESS (legs got really weak) outcome was unknown.            No relevant concomitant medications were reported. Treatment information was not reported.   This case was linked to MOD-2021-393282 (Patient Link).
Age: 61.0
Sex: F
Vaccine: COVID19
Symptoms: Arthralgia, Chills, Pain, Pyrexia, Vaccination site rash
Clinical narrative: Aches; COVID arm/ A huge swollen rash at the injection site that is 6 inches wide and 6 inches long; it is red and hot; Fever; Chills; Joint pain; This spontaneous case was reported by a consumer and describes the occurrence of PAIN (Aches), VACCINATION SITE RASH (COVID arm/ A huge swollen rash at the injection site that is 6 inches wide and 6 inches long; it is red and hot), PYREXIA (Fever), CHILLS (Chills) and ARTHRALGIA (Joint pain) in a 61-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 071F21A, 012M20A and 011A21A) 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. On 16-Nov-2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 17-Nov-2021, the patient experienced PAIN (Aches), VACCINATION SITE RASH (COVID arm/ A huge swollen rash at the injection site that is 6 inches wide and 6 inches long; it is red and hot), PYREXIA (Fever), CHILLS (Chills) and ARTHRALGIA (Joint pain). The patient was treated with CETIRIZINE for Adverse event, at a dose of 10 milligram and IBUPROFEN for Adverse event, at a dose of 200 milligram. At the time of the report, PAIN (Aches), VACCINATION SITE RASH (COVID arm/ A huge swollen rash at the injection site that is 6 inches wide and 6 inches long; it is red and hot), PYREXIA (Fever), CHILLS (Chills) and ARTHRALGIA (Joint pain) outcome was unknown.            No concomitant medication was reported by the reporter.  Patient had side effect after receiving the Moderna COVID 19 vaccine. 24 hours after receiving the booster, patient had fever, chills, joint pain, aches and a huge swollen rash at the injection site that is 6 inches wide and 6 inches long- it was red and hot. Patient looked online and it was called the COVID arm. Patient had taken antihistamine generic Kroger brand- Cetirizine 10 mg and pain reliever Ibuprofen 200 mg.  Patient had consulted physician through email and was told to take pain reliever, antihistamine and cortisone.   This case was linked to MOD-2021-393302, MOD-2021-393289 (Patient Link).
Age: 69.0
Sex: F
Vaccine: COVID19
Symptoms: Chills, Fatigue, Pyrexia
Clinical narrative: Low grade fever; chills; Wiped out; This spontaneous case was reported by a consumer and describes the occurrence of PYREXIA (Low grade fever), CHILLS (chills) and FATIGUE (Wiped out) in a 69-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 025L20A) for COVID-19 vaccination.     The patient's past medical history included Cancer. Concurrent medical conditions included Achalasia (Autoimmune disorder of esophagus.) and Swallowing disorder. Concomitant products included TRAZODONE for an unknown indication.    On 08-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced PYREXIA (Low grade fever), CHILLS (chills) and FATIGUE (Wiped out). The patient was treated with PARACETAMOL (TYLENOL [PARACETAMOL]) for Adverse event, at an unspecified dose and frequency. At the time of the report, PYREXIA (Low grade fever), CHILLS (chills) and FATIGUE (Wiped out) outcome was unknown.        mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) dosing remained unchanged.       This case was linked to MOD-2021-393447, MOD-2021-391917.
Age: 70.0
Sex: F
Vaccine: COVID19
Symptoms: Fatigue
Clinical narrative: very bad fatigue (2nd dose); This spontaneous case was reported by a consumer and describes the occurrence of FATIGUE (very bad fatigue (2nd dose)) in a 70-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 013M20A and 025L20A) for COVID-19 vaccination.     The patient's past medical history included Cancer and Achalasia (an autoimmune disorder of the esophagus). Concurrent medical conditions included Swallowing disorder. Concomitant products included TRAZODONE for an unknown indication.   On 08-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 05-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient experienced FATIGUE (very bad fatigue (2nd dose)). The patient was treated with PARACETAMOL (TYLENOL [PARACETAMOL]) at an unspecified dose and frequency. At the time of the report, FATIGUE (very bad fatigue (2nd dose)) outcome was unknown.            This case was linked to MOD-2021-393446, MOD-2021-391917 (Patient Link).
Age: 53.0
Sex: F
Vaccine: COVID19
Symptoms: Feeling abnormal, Myalgia, Pyrexia, Vaccination site induration, Vaccination site pain
Clinical narrative: Feels like ants on my arm; arm is hot; skin of her injection site left arm is as hard as a knot; elbow to the injection site the area is painful; super bad body aches; area itches/itching is widespread/itching goes to shoulder blades/itching has become progressively worse since it first stared/itching is excruciating/My entire arm itches; low grade fever; This spontaneous case was reported by a consumer and describes the occurrence of FEELING ABNORMAL (Feels like ants on my arm), VACCINATION SITE WARMTH (arm is hot), VACCINATION SITE INDURATION (skin of her injection site left arm is as hard as a knot), VACCINATION SITE PAIN (elbow to the injection site the area is painful) and MYALGIA (super bad body aches) in a 53-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 034F21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.    On 13-Nov-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 14-Nov-2021, the patient experienced MYALGIA (super bad body aches), VACCINATION SITE PRURITUS (area itches/itching is widespread/itching goes to shoulder blades/itching has become progressively worse since it first stared/itching is excruciating/My entire arm itches) and PYREXIA (low grade fever). On an unknown date, the patient experienced FEELING ABNORMAL (Feels like ants on my arm), VACCINATION SITE WARMTH (arm is hot), VACCINATION SITE INDURATION (skin of her injection site left arm is as hard as a knot) and VACCINATION SITE PAIN (elbow to the injection site the area is painful). On 14-Nov-2021, MYALGIA (super bad body aches) had resolved. On 15-Nov-2021, PYREXIA (low grade fever) had resolved. At the time of the report, FEELING ABNORMAL (Feels like ants on my arm), VACCINATION SITE WARMTH (arm is hot), VACCINATION SITE INDURATION (skin of her injection site left arm is as hard as a knot), VACCINATION SITE PAIN (elbow to the injection site the area is painful) and VACCINATION SITE PRURITUS (area itches/itching is widespread/itching goes to shoulder blades/itching has become progressively worse since it first stared/itching is excruciating/My entire arm itches) had not resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant medication was provided by reporter. No treatment information was provided by reporter.
Age: 53.0
Sex: F
Vaccine: COVID19
Symptoms: Vaccination site pruritus, Vaccination site warmth
Clinical narrative: Feels like ants on my arm; arm is hot; skin of her injection site left arm is as hard as a knot; elbow to the injection site the area is painful; super bad body aches; area itches/itching is widespread/itching goes to shoulder blades/itching has become progressively worse since it first stared/itching is excruciating/My entire arm itches; low grade fever; This spontaneous case was reported by a consumer and describes the occurrence of FEELING ABNORMAL (Feels like ants on my arm), VACCINATION SITE WARMTH (arm is hot), VACCINATION SITE INDURATION (skin of her injection site left arm is as hard as a knot), VACCINATION SITE PAIN (elbow to the injection site the area is painful) and MYALGIA (super bad body aches) in a 53-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 034F21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.    On 13-Nov-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 14-Nov-2021, the patient experienced MYALGIA (super bad body aches), VACCINATION SITE PRURITUS (area itches/itching is widespread/itching goes to shoulder blades/itching has become progressively worse since it first stared/itching is excruciating/My entire arm itches) and PYREXIA (low grade fever). On an unknown date, the patient experienced FEELING ABNORMAL (Feels like ants on my arm), VACCINATION SITE WARMTH (arm is hot), VACCINATION SITE INDURATION (skin of her injection site left arm is as hard as a knot) and VACCINATION SITE PAIN (elbow to the injection site the area is painful). On 14-Nov-2021, MYALGIA (super bad body aches) had resolved. On 15-Nov-2021, PYREXIA (low grade fever) had resolved. At the time of the report, FEELING ABNORMAL (Feels like ants on my arm), VACCINATION SITE WARMTH (arm is hot), VACCINATION SITE INDURATION (skin of her injection site left arm is as hard as a knot), VACCINATION SITE PAIN (elbow to the injection site the area is painful) and VACCINATION SITE PRURITUS (area itches/itching is widespread/itching goes to shoulder blades/itching has become progressively worse since it first stared/itching is excruciating/My entire arm itches) had not resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant medication was provided by reporter. No treatment information was provided by reporter.