chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 78.0
Sex: M
Vaccine: COVID19
Symptoms: Expired product administered, Product storage error
Clinical narrative: Dose left out at room temperature for more than 24 hours; Dose left out at room temperature for more than 24 hours; This spontaneous case was reported by a pharmacist and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Dose left out at room temperature for more than 24 hours) and PRODUCT STORAGE ERROR (Dose left out at room temperature for more than 24 hours) in a 78-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On 18-Oct-2021, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 17-Oct-2021, the patient experienced PRODUCT STORAGE ERROR (Dose left out at room temperature for more than 24 hours). On 18-Oct-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (Dose left out at room temperature for more than 24 hours). On 17-Oct-2021, PRODUCT STORAGE ERROR (Dose left out at room temperature for more than 24 hours) had resolved. On 18-Oct-2021, EXPIRED PRODUCT ADMINISTERED (Dose left out at room temperature for more than 24 hours) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant medication reported. No treatment information was provided The pharmacist has a vial of Moderna COVID19 Vaccine that was open yesterday 18Oct2021 around noon. They administered 2 doses of that vial today 18Oct2021 around 11:30 EST.The dates of his first two doses are unknown as he did not receive them from this pharmacy
Sex: U
Vaccine: COVID19
Symptoms: Expired product administered
Clinical narrative: 1 dose administered from dose, "unsure of expired or not"; Based on the current case data, this case has been classified as invalid. This spontaneous case was reported by a nurse and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (1 dose administered from dose, "unsure of expired or not") in a  patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 003C21A) for COVID-19 vaccination.     No Medical History information was reported.    On 18-Oct-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 18-Oct-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (1 dose administered from dose, "unsure of expired or not"). On 18-Oct-2021, EXPIRED PRODUCT ADMINISTERED (1 dose administered from dose, "unsure of expired or not") had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   Dose administered after 30-day Use By Date or after manufacturer date of expiry,Nurse utilizes the lot  does not state this lot number is expired and shows as expiration of "21Dec2069". Number of doses/vials: 1 dose from 1 vial. The vial was initially stored in the refrigerator and  was pulled out of freezer and utilized. The vial   doesn't undergo any temperature excursions. Concomitant medication use was unknown Treatment information was unknown.
Age: 66.0
Sex: F
Vaccine: COVID19
Symptoms: Expired product administered
Clinical narrative: Expired dose- vial left in refrigerator for more than  30 days; This spontaneous case was reported by a pharmacist and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Expired dose- vial left in refrigerator for more than  30 days) in a 66-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 048C21A) 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 18-Oct-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (Expired dose- vial left in refrigerator for more than  30 days). At the time of the report, EXPIRED PRODUCT ADMINISTERED (Expired dose- vial left in refrigerator for more than  30 days) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   Concomitant medications was not provided by the reporter Treatment information was not provided   This case was linked to MOD-2021-355908 (Patient Link).
Age: 68.0
Sex: M
Vaccine: COVID19
Symptoms: Expired product administered
Clinical narrative: Received expired second dose; This spontaneous case was reported by an other health care professional and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Received expired second dose) in a 68-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 006C21A and 006C21A) for COVID-19 vaccination.     No Medical History information was reported.   On 13-Sep-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 11-Oct-2021 at 8:30 AM, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 11-Oct-2021,  after starting mRNA-1273 (Moderna COVID-19 Vaccine), the patient experienced EXPIRED PRODUCT ADMINISTERED (Received expired second dose). On 11-Oct-2021, EXPIRED PRODUCT ADMINISTERED (Received expired second dose) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   Concomitant medication was not provided. Treatment information was not provided.   Most recent FOLLOW-UP information incorporated above includes: On 19-Oct-2021: Follow up include the Reporter information (Alternate phone number), Patient demographics (Race, Ethnic group) and Vaccine information (Anatomical location and Route of administration).
Sex: U
Vaccine: COVID19
Symptoms: Expired product administered, Product storage error
Clinical narrative: received dose after expiration time/Administering vaccine after expiration; the vial was exposed to room temperature range 8° to 25°C= 46° to 77°F; 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 (received dose after expiration time/Administering vaccine after expiration) and PRODUCT STORAGE ERROR (the vial was exposed to room temperature range 8° to 25°C= 46° to 77°F) in a  patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 037F21A) 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 EXPIRED PRODUCT ADMINISTERED (received dose after expiration time/Administering vaccine after expiration) and PRODUCT STORAGE ERROR (the vial was exposed to room temperature range 8° to 25°C= 46° to 77°F). On 18-Oct-2021, EXPIRED PRODUCT ADMINISTERED (received dose after expiration time/Administering vaccine after expiration) and PRODUCT STORAGE ERROR (the vial was exposed to room temperature range 8° to 25°C= 46° to 77°F) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant drug details were reported. No treatment details were reported.   Most recent FOLLOW-UP information incorporated above includes: On 18-Oct-2021: Non-significant Follow Up received updated Event verbatim.
Sex: U
Vaccine: COVID19
Symptoms: Expired product administered
Clinical narrative: administered 16 doses on 12Oct2021 (2 days after expiry); Based on the current case data, this case has been classified as invalid. This spontaneous case was reported by a nurse and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (administered 16 doses on 12Oct2021 (2 days after expiry)) in a  patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 006C21A) for COVID-19 vaccination.     Medical history was not provided.     On 12-Oct-2021, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 12-Oct-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (administered 16 doses on 12Oct2021 (2 days after expiry)). On 12-Oct-2021, EXPIRED PRODUCT ADMINISTERED (administered 16 doses on 12Oct2021 (2 days after expiry)) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   Concomitant medication information was not provided by the reporter.  Treatment information was not provided by the reporter.
Sex: F
Vaccine: COVID19
Symptoms: Diarrhoea
Clinical narrative: Diarrhea since the first dose/Chronic diarrhea / He stated that 7 months later they are still taking medications (anti-diarrheal treatment).; This spontaneous case was reported by a physician and describes the occurrence of DIARRHOEA (Diarrhea since the first dose/Chronic diarrhea / He stated that 7 months later they are still taking medications (anti-diarrheal treatment).) 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.    In March 2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. In March 2021, the patient experienced DIARRHOEA (Diarrhea since the first dose/Chronic diarrhea / He stated that 7 months later they are still taking medications (anti-diarrheal treatment).). At the time of the report, DIARRHOEA (Diarrhea since the first dose/Chronic diarrhea / He stated that 7 months later they are still taking medications (anti-diarrheal treatment).) had not resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant medications reported.  The patient stated that they had diarrhea (chronic diarrhea) since their 1st dose. He stated that 7 months later they were still taking medications (anti-diarrheal treatment). Before,they had diarrheal episodes 6-7 times a day but now it is 2-3 times a day.  The patient was taking unspecified anti-diarrheal medications.   This case was linked to MOD-2021-355994 (Patient Link).
Age: 79.0
Sex: M
Vaccine: COVID19
Symptoms: Off label use
Clinical narrative: patient was given a 3rd dose prior to 28 days after his 2nd dose/patient was given a 3rd dose and was not immunocompromised; This spontaneous case was reported by a pharmacist and describes the occurrence of OFF LABEL USE (patient was given a 3rd dose prior to 28 days after his 2nd dose/patient was given a 3rd dose and was not immunocompromised) in a 79-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 012F21A, 051E21A and 052E21A) for COVID-19 vaccination.     No Medical History information was reported.   On 10-Aug-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 27-Sep-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 18-Oct-2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 18-Oct-2021,  after starting mRNA-1273 (Moderna COVID-19 Vaccine), the patient experienced OFF LABEL USE (patient was given a 3rd dose prior to 28 days after his 2nd dose/patient was given a 3rd dose and was not immunocompromised). On 18-Oct-2021, OFF LABEL USE (patient was given a 3rd dose prior to 28 days after his 2nd dose/patient was given a 3rd dose and was not immunocompromised) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   The pharmacist reported that the patient had presented like it was his second dose but then after administering the dose, it was realized that it was a third dose. The patient was not immunocompromised.  Concomitant product use was not provided by the reporter. Treatment information was not provided by the reporter.
Sex: F
Vaccine: COVID19
Symptoms: Dyspnoea
Clinical narrative: Getting short breath; This spontaneous case was reported by a consumer and describes the occurrence of DYSPNOEA (Getting short breath) 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 dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced DYSPNOEA (Getting short breath). At the time of the report, DYSPNOEA (Getting short breath) outcome was unknown.      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.   No concomitant medication was reported.  No treatment medication use was reported.
Age: 82.0
Sex: F
Vaccine: COVID19
Symptoms: Expired product administered
Clinical narrative: Vial left in refrigerator for more than 30 days; This spontaneous case was reported by a pharmacist and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Vial left in refrigerator for more than 30 days) in an 82-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 048C21A and 036A21A) for COVID-19 vaccination.     No Medical History information was reported.   On 04-Mar-2021, the patient 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 received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced EXPIRED PRODUCT ADMINISTERED (Vial left in refrigerator for more than 30 days). At the time of the report, EXPIRED PRODUCT ADMINISTERED (Vial left in refrigerator for more than 30 days) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant medications or treatment details were reported.   This case was linked to MOD-2021-355908, MOD-2021-355908 (Patient Link).   Most recent FOLLOW-UP information incorporated above includes: On 18-Oct-2021: Patient demographics and second dose details were updated
Sex: M
Vaccine: COVID19
Symptoms: Dyspnoea, Pain in extremity
Clinical narrative: painful legs; trouble breathing; This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (painful legs) and DYSPNOEA (trouble breathing) in a male patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 023M20A) for COVID-19 vaccination.     No Medical History information was reported.    On 15-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 15-Mar-2021, the patient experienced PAIN IN EXTREMITY (painful legs) and DYSPNOEA (trouble breathing). At the time of the report, PAIN IN EXTREMITY (painful legs) and DYSPNOEA (trouble breathing) outcome was unknown.            No concomitant medications or treatment details were reported.  Patient received the second dose on 14-Apr-2021 with Lot Number-044A21A.
Age: 57.0
Sex: F
Vaccine: COVID19
Symptoms: Influenza like illness, Parkinsonian rest tremor
Clinical narrative: an increase in my Parkinsons' Tremor; flu like symptoms; This spontaneous case was reported by a consumer and describes the occurrence of PARKINSONIAN REST TREMOR (an increase in my Parkinsons' Tremor) and INFLUENZA LIKE ILLNESS (flu like symptoms) in a 57-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     Concurrent medical conditions included Immunocompromised, Parkinsonian-like tremor and Seasonal allergy.    On 14-Oct-2021, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 14-Oct-2021, the patient experienced PARKINSONIAN REST TREMOR (an increase in my Parkinsons' Tremor) and INFLUENZA LIKE ILLNESS (flu like symptoms). At the time of the report, PARKINSONIAN REST TREMOR (an increase in my Parkinsons' Tremor) and INFLUENZA LIKE ILLNESS (flu like symptoms) outcome was unknown.            Concomitant medication of the patient was not reported.  No treatment information was provided by the reporter.   This case was linked to MOD-2021-355965, MOD-2021-355986 (Patient Link).
Sex: F
Vaccine: COVID19
Symptoms: Inappropriate schedule of product administration, Paraesthesia, Pruritus, Vaccination complication
Clinical narrative: Itching in left hand in palm/itching in left hand; Tingling in left hand/tingling in right hand; Symptoms started showing up/she didn't like the side effects; Her first dose was in August and second dose was in the first week of October; This spontaneous case was reported by a consumer and describes the occurrence of PRURITUS (Itching in left hand in palm/itching in left hand), PARAESTHESIA (Tingling in left hand/tingling in right hand), VACCINATION COMPLICATION (Symptoms started showing up/she didn't like the side effects) and INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Her first dose was in August and second dose was in the first week of October) 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.   In August 2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. In October 2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. In October 2021, the patient experienced PRURITUS (Itching in left hand in palm/itching in left hand), PARAESTHESIA (Tingling in left hand/tingling in right hand), VACCINATION COMPLICATION (Symptoms started showing up/she didn't like the side effects) and INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Her first dose was in August and second dose was in the first week of October). In October 2021, INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Her first dose was in August and second dose was in the first week of October) had resolved. At the time of the report, PRURITUS (Itching in left hand in palm/itching in left hand), PARAESTHESIA (Tingling in left hand/tingling in right hand) and VACCINATION COMPLICATION (Symptoms started showing up/she didn't like the side effects) outcome was unknown.            Concomitant medication of the patient was not reported.  The patient received the first dose was in August and second dose was in the first week of October. She did not remember the exact dates. The patient experienced no symptoms from the first dose.  Before she received her first dose, she was very nervous about receiving the vaccines. However, she had to get it because she works as a caregiver and the lady for whom she was working for was old; so she asked her to get the vaccine.   No treatment information was provided by the reporter.
Age: 19.0
Sex: F
Vaccine: COVID19
Symptoms: Asthenia, Chills, Product dose omission issue, Pyrexia
Clinical narrative: Weak; Fever/She had fever for a day in half; Chills; Patient missed her 2nd dose of the vaccine; This spontaneous case was reported by a consumer and describes the occurrence of ASTHENIA (Weak), PYREXIA (Fever/She had fever for a day in half), CHILLS (Chills) and PRODUCT DOSE OMISSION ISSUE (Patient missed her 2nd dose of the vaccine) in a 20-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 039B21A) for COVID-19 vaccination.     No Medical History information was reported.    On 15-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced ASTHENIA (Weak), PYREXIA (Fever/She had fever for a day in half), CHILLS (Chills) and PRODUCT DOSE OMISSION ISSUE (Patient missed her 2nd dose of the vaccine). At the time of the report, ASTHENIA (Weak) and CHILLS (Chills) outcome was unknown and PYREXIA (Fever/She had fever for a day in half) and PRODUCT DOSE OMISSION ISSUE (Patient missed her 2nd dose of the vaccine) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       The patient was not taking any concomitant medications. No treatment details were reported.  Patient missed her second dose as her vaccination location was closed. Her HCP was not aware that she did not get her second dose.
Age: 71.0
Sex: F
Vaccine: COVID19
Symptoms: Chills, Diarrhoea, Illness, Vomiting, Weight
Clinical narrative: she got sick after the second dose; diarrhea; throwing up; chills; This spontaneous case was reported by a consumer and describes the occurrence of ILLNESS (she got sick after the second dose), DIARRHOEA (diarrhea), VOMITING (throwing up) and CHILLS (chills) in a 71-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 010A21A and 010M20A) for COVID-19 vaccination.     The patient had no known drug or food allergies.  Concurrent medical conditions included Latex allergy (some medication sensitivities including latex).   On 06-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 06-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 06-Mar-2021, the patient experienced ILLNESS (she got sick after the second dose), DIARRHOEA (diarrhea), VOMITING (throwing up) and CHILLS (chills). On 07-Mar-2021, ILLNESS (she got sick after the second dose), DIARRHOEA (diarrhea), VOMITING (throwing up) and CHILLS (chills) had resolved.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, Weight: abnormal (abnormal) She had gained 25 lbs, since she had been sitting in the house since COVID-19 began..         Concomitant medication of the patient was not reported.  No treatment information was provided by the reporter.   This case was linked to MOD-2021-355964 (Patient Link).
Sex: U
Vaccine: COVID19
Symptoms: Expired product administered
Clinical narrative: They gave 24 doses from this lot that expired on 8Oct2021; This case was received via an unknown source (no reference has been entered for a health authority or license partner) on 18-Oct-2021 and was forwarded to Moderna on 18-Oct-2021.    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 (They gave 24 doses from this lot that expired on 8Oct2021) in a  patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 045B21A) 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 (They gave 24 doses from this lot that expired on 8Oct2021). At the time of the report, EXPIRED PRODUCT ADMINISTERED (They gave 24 doses from this lot that expired on 8Oct2021) 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: 64.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Vaccination site pain
Clinical narrative: sore injection site arm; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE PAIN (sore injection site arm) in a 64-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 002B21A) for COVID-19 vaccination.     Concurrent medical conditions included Menopausal.    On 17-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 17-Mar-2021, the patient experienced VACCINATION SITE PAIN (sore injection site arm). At the time of the report, VACCINATION SITE PAIN (sore injection site arm) outcome was unknown.        mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosing remained unchanged.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   No concomitant medication listed.  No treatment information provided. In May June, and July patient felt like she was having Menstrual symptoms.  In August Patient had a full fledged period.  Patient's Doctor performed an ultrasound a month ago and she have eggs. Her next ultrasound is scheduled for November 1, 2021.   This case was linked to MOD-2021-356223 (Patient Link).
Age: 64.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Feeling abnormal, Myalgia, Postmenopausal haemorrhage, Pyrexia, Ultrasound scan
Clinical narrative: sore injection site arm; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE PAIN (sore injection site arm) in a 64-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 002B21A) for COVID-19 vaccination.     Concurrent medical conditions included Menopausal.    On 17-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 17-Mar-2021, the patient experienced VACCINATION SITE PAIN (sore injection site arm). At the time of the report, VACCINATION SITE PAIN (sore injection site arm) outcome was unknown.        mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosing remained unchanged.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   No concomitant medication listed.  No treatment information provided. In May June, and July patient felt like she was having Menstrual symptoms.  In August Patient had a full fledged period.  Patient's Doctor performed an ultrasound a month ago and she have eggs. Her next ultrasound is scheduled for November 1, 2021.   This case was linked to MOD-2021-356223 (Patient Link).
Age: 64.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Vaccination site pain
Clinical narrative: In August I had a full fledged period. I have been Menopausal for several years; achy; fever for 24 hours; felt like I got kicked by a bus; This spontaneous case was reported by a consumer and describes the occurrence of FEELING ABNORMAL (felt like I got kicked by a bus), POSTMENOPAUSAL HAEMORRHAGE (In August I had a full fledged period. I have been Menopausal for several years), MYALGIA (achy) and PYREXIA (fever for 24 hours) in a 64-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 031B21o and 002B21A) for COVID-19 vaccination.     No Medical History information was reported.   On 17-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 14-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 14-Apr-2021, the patient experienced FEELING ABNORMAL (felt like I got kicked by a bus), MYALGIA (achy) and PYREXIA (fever for 24 hours). In August 2021, the patient experienced POSTMENOPAUSAL HAEMORRHAGE (In August I had a full fledged period. I have been Menopausal for several years). At the time of the report, FEELING ABNORMAL (felt like I got kicked by a bus), POSTMENOPAUSAL HAEMORRHAGE (In August I had a full fledged period. I have been Menopausal for several years) and MYALGIA (achy) outcome was unknown and PYREXIA (fever for 24 hours) had resolved.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): In September 2021, Ultrasound scan: abnormal (abnormal) ultrasound shows that I have eggs.     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. Patient had been Menopausal for several years Patient next ultrasound scheduled for 01- Nov-2021.   This case was linked to MOD-2021-355962 (Patient Link).; Sender's Comments: This is a spontaneous case concerning a 64-year-old female patient with no relevant medical history reported, who experienced non-serious unexpected event of Postmenopausal Haemorrhage. The event occurred approximately 4 months after the second dose of mRNA-1273 (in August, exact onset date not provided). The rechallenge was not applicable as no additional dosing is expected. The benefit-risk relationship of mRNA-1273 is not affected by this report.. The event postmenopausal haemorrhage is marked serious by the auto-seriousness tool. Case downgraded to non-serious due to the lack of evidence of seriousness from a clinical or regulatory standpoint, and reporter assessed the case as non-serious.
Age: 64.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Feeling abnormal, Myalgia, Postmenopausal haemorrhage, Pyrexia, Ultrasound scan
Clinical narrative: In August I had a full fledged period. I have been Menopausal for several years; achy; fever for 24 hours; felt like I got kicked by a bus; This spontaneous case was reported by a consumer and describes the occurrence of FEELING ABNORMAL (felt like I got kicked by a bus), POSTMENOPAUSAL HAEMORRHAGE (In August I had a full fledged period. I have been Menopausal for several years), MYALGIA (achy) and PYREXIA (fever for 24 hours) in a 64-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 031B21o and 002B21A) for COVID-19 vaccination.     No Medical History information was reported.   On 17-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 14-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 14-Apr-2021, the patient experienced FEELING ABNORMAL (felt like I got kicked by a bus), MYALGIA (achy) and PYREXIA (fever for 24 hours). In August 2021, the patient experienced POSTMENOPAUSAL HAEMORRHAGE (In August I had a full fledged period. I have been Menopausal for several years). At the time of the report, FEELING ABNORMAL (felt like I got kicked by a bus), POSTMENOPAUSAL HAEMORRHAGE (In August I had a full fledged period. I have been Menopausal for several years) and MYALGIA (achy) outcome was unknown and PYREXIA (fever for 24 hours) had resolved.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): In September 2021, Ultrasound scan: abnormal (abnormal) ultrasound shows that I have eggs.     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. Patient had been Menopausal for several years Patient next ultrasound scheduled for 01- Nov-2021.   This case was linked to MOD-2021-355962 (Patient Link).; Sender's Comments: This is a spontaneous case concerning a 64-year-old female patient with no relevant medical history reported, who experienced non-serious unexpected event of Postmenopausal Haemorrhage. The event occurred approximately 4 months after the second dose of mRNA-1273 (in August, exact onset date not provided). The rechallenge was not applicable as no additional dosing is expected. The benefit-risk relationship of mRNA-1273 is not affected by this report.. The event postmenopausal haemorrhage is marked serious by the auto-seriousness tool. Case downgraded to non-serious due to the lack of evidence of seriousness from a clinical or regulatory standpoint, and reporter assessed the case as non-serious.
Age: 68.0
Sex: F
Vaccine: COVID19
Symptoms: Expired product administered
Clinical narrative: Dose administered out a vial which was left in refrigerator for more than 30 days.; This spontaneous case was reported by a pharmacist and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Dose administered out a vial which was left in refrigerator for more than 30 days.) in a 68-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 048C21A and 041C21A) for COVID-19 vaccination.     No Medical History information was reported.   On 18-Oct-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 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 18-Oct-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (Dose administered out a vial which was left in refrigerator for more than 30 days.). On 18-Oct-2021, EXPIRED PRODUCT ADMINISTERED (Dose administered out a vial which was left in refrigerator for more than 30 days.) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   No Concomitant medications were provided by the reporter. No Treatment information was reported.   This case was linked to MOD-2021-355908, MOD-2021-355908 (Patient Link).   Most recent FOLLOW-UP information incorporated above includes: On 18-Oct-2021: Significant followup appended on 18-Oct-2021,Gender of patient confirmed by Pharmacist reported as Female.
Age: 57.0
Sex: F
Vaccine: COVID19
Symptoms: Parkinsonian rest tremor, Vaccination complication
Clinical narrative: experienced an increase in my Parkinson's tremor; had reactions like I have when I have seasonal allergy symptoms; This spontaneous case was reported by a consumer and describes the occurrence of PARKINSONIAN REST TREMOR (experienced an increase in my Parkinson's tremor) and VACCINATION COMPLICATION (had reactions like I have when I have seasonal allergy symptoms) in a 57-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 044821A) for COVID-19 vaccination.     Concurrent medical conditions included Seasonal allergy, Parkinsonian-like tremor and Immunocompromised.    On 30-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 30-Mar-2021, the patient experienced PARKINSONIAN REST TREMOR (experienced an increase in my Parkinson's tremor) and VACCINATION COMPLICATION (had reactions like I have when I have seasonal allergy symptoms). At the time of the report, PARKINSONIAN REST TREMOR (experienced an increase in my Parkinson's tremor) and VACCINATION COMPLICATION (had reactions like I have when I have seasonal allergy symptoms) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Concomitant medication of the patient was not reported.  No treatment information was provided by the reporter.   This case was linked to MOD-2021-355938, MOD-2021-355986 (Patient Link).
Age: 85.0
Sex: M
Vaccine: COVID19
Symptoms: Pemphigoid, Tachycardia
Clinical narrative: Tachycardia; Rare skin condition called Bullous Pemphigoid; This spontaneous case was reported by a consumer and describes the occurrence of TACHYCARDIA (Tachycardia) and PEMPHIGOID (Rare skin condition called Bullous Pemphigoid) in an 85-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    In April 2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced TACHYCARDIA (Tachycardia) (seriousness criterion medically significant) and PEMPHIGOID (Rare skin condition called Bullous Pemphigoid) (seriousness criterion medically significant). At the time of the report, TACHYCARDIA (Tachycardia) and PEMPHIGOID (Rare skin condition called Bullous Pemphigoid) outcome was unknown.            Concomitant product was not provided.  Caller stated that her grandfather who is 85 years old received the 2nd dose of the Moderna COVID 19 vaccine in APR2021. Months later he was diagnosed with tachycardia and his doctors are recommending pacemaker; he has also developed a rare skin condition called Bullous Pemphigoid. She stated that he has never had heart issues before. She declined to provide patient's information or medication information.  Treatment medication was not reported.  This case concerns an 85-year-old male patient with no relevant medical history, who experienced the unexpected events of Tachycardia and Pemphigoid. The event occurred an unknown date after receiving a dose of mRNA-1273 (Moderna COVID-19 Vaccine). The rechallenge was unknown since no dose number was disclosed. The benefit-risk relationship of mRNA-1273 (Moderna COVID-19 Vaccine) is not affected by this report.; Sender's Comments: This case concerns an 85-year-old male patient with no relevant medical history, who experienced the unexpected events of Tachycardia and Pemphigoid. The event occurred an unknown date after receiving a dose of mRNA-1273 (Moderna COVID-19 Vaccine). The rechallenge was unknown since no dose number was disclosed. The benefit-risk relationship of mRNA-1273 (Moderna COVID-19 Vaccine) is not affected by this report.
Age: 57.0
Sex: F
Vaccine: COVID19
Symptoms: Tremor
Clinical narrative: experienced an increase in my Parkinson's tremor; This spontaneous case was reported by a consumer and describes the occurrence of TREMOR (experienced an increase in my Parkinson's tremor) in a 57-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 619F21A) for COVID-19 vaccination.     Concurrent medical conditions included Parkinsonian-like tremor, Immunocompromised and Seasonal allergy.    In 2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. In 2021, the patient experienced TREMOR (experienced an increase in my Parkinson's tremor). At the time of the report, TREMOR (experienced an increase in my Parkinson's tremor) outcome was unknown.            Concomitant medication of the patient was not reported.  It was reported that post receiving the second dose of vaccine patient started to experience increase in Parkinson's tremor.  No treatment information was provided by the reporter.   This case was linked to MOD-2021-355965, MOD-2021-355938 (Patient Link).
Age: 51.0
Sex: F
Vaccine: COVID19
Symptoms: Arthralgia
Clinical narrative: shoulder was tender after first dose; This spontaneous case was reported by a consumer and describes the occurrence of ARTHRALGIA (shoulder was tender after first dose) in a 51-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 007C21A) for COVID-19 vaccination.     Concurrent medical conditions included Seizure.    On 07-Jun-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. In June 2021, the patient experienced ARTHRALGIA (shoulder was tender after first dose). At the time of the report, ARTHRALGIA (shoulder was tender after first dose) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Concomitant medication included unspecified seizure medication.  No treatment information was provided for first dose.   This case was linked to MOD-2021-356019 (Patient Link).
Age: 74.0
Sex: M
Vaccine: COVID19
Symptoms: Vaccination complication
Clinical narrative: just had usual side effects and mild symptoms for 48 hours.; This spontaneous case was reported by a physician and describes the occurrence of VACCINATION COMPLICATION (just had usual side effects and mild symptoms for 48 hours.) in a 74-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 012M20A and 012L20A) for COVID-19 vaccination.     No Medical History information was reported.   On 23-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 20-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 20-Feb-2021,  after starting mRNA-1273 (Moderna COVID-19 Vaccine), the patient experienced VACCINATION COMPLICATION (just had usual side effects and mild symptoms for 48 hours.). On 22-Feb-2021, VACCINATION COMPLICATION (just had usual side effects and mild symptoms for 48 hours.) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   No concomitant medications were provided. No treatment medications were provided.   This case was linked to MOD-2021-355923 (Patient Link).   Most recent FOLLOW-UP information incorporated above includes: On 19-Oct-2021: Follow-up information received contains no new information
Age: 81.0
Sex: M
Vaccine: COVID19
Symptoms: Myalgia, Vaccination site pain
Clinical narrative: Sore muscle; Soreness at injection site; This case was received via an unknown source (no reference has been entered for a health authority or license partner) on 18-Oct-2021 and was forwarded to Moderna on 18-Oct-2021.    This spontaneous case was reported by a consumer and describes the occurrence of MYALGIA (Sore muscle) and VACCINATION SITE PAIN (Soreness at injection site) in an 81-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 029L20A) for COVID-19 vaccination.     No Medical History information was reported.    On 21-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 10-Feb-2021, the patient experienced MYALGIA (Sore muscle) and VACCINATION SITE PAIN (Soreness at injection site). On 11-Feb-2021, MYALGIA (Sore muscle) and VACCINATION SITE PAIN (Soreness at injection site) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No concomitant medications were provided. No treatment medications were reported.   This case was linked to MOD-2021-355999 (Patient Link).
Sex: U
Vaccine: COVID19
Symptoms: Expired product administered
Clinical narrative: they gave 9 doses from 1 vial (lot # 044A21A ) on 2Sep2021 from a vial that expired 31Aug2021; Based on the current case data, this case has been classified as invalid. This spontaneous case was reported by a nurse and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (they gave 9 doses from 1 vial (lot # 044A21A ) on 2Sep2021 from a vial that expired 31Aug2021) 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 (they gave 9 doses from 1 vial (lot # 044A21A ) on 2Sep2021 from a vial that expired 31Aug2021). At the time of the report, EXPIRED PRODUCT ADMINISTERED (they gave 9 doses from 1 vial (lot # 044A21A ) on 2Sep2021 from a vial that expired 31Aug2021) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   Concomitant and treatment medications were not reported.
Age: 20.0
Sex: F
Vaccine: COVID19
Symptoms: Expired product administered
Clinical narrative: received a vial that was punctured more than 12 hours ago; This spontaneous case was reported by a pharmacist and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (received a vial that was punctured more than 12 hours ago) in a 3-decade-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 026D21A) for COVID-19 vaccination.     No Medical History information was reported.    On 18-Oct-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 18-Oct-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (received a vial that was punctured more than 12 hours ago). On 18-Oct-2021, EXPIRED PRODUCT ADMINISTERED (received a vial that was punctured more than 12 hours ago) had resolved.        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.  The vial was initially stored in the refrigerator and was first punctured on 15-Oct-2021 around 9-10 o'clock. the vial was stored at room temperature post puncture. The vial did not undergo any temperature excursions. Total amount of time the vial was exposed to room temperature range (8° to 25°C= 46° to 77°F): Around 2 days.
Age: 80.0
Sex: M
Vaccine: COVID19
Symptoms: Cardiac disorder
Clinical narrative: about to have open heart surgery; This spontaneous case was reported by a consumer and describes the occurrence of CARDIAC DISORDER (about to have open heart surgery) in an 80-year-old male patient 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 CARDIAC DISORDER (about to have open heart surgery) (seriousness criterion medically significant). At the time of the report, CARDIAC DISORDER (about to have open heart surgery) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       Patient was 80 years of age and stated his husband "needs a booster dose as he is going to have open heart surgery"  Concomitant medication use was unknown Treatment information was unknown  This case involves an 80-year-old male subject with no information about the medical history who was supposed to have open heart surgery for an undisclosed cardiac disorder. No details were provided about previous mRNA-1273 vaccinations. The request for a booster vaccination makes it likely that 2 doses had been given before.   The benefit-risk relationship of mRNA-1273 was not affected by this report.; Sender's Comments: This case involves an 80-year-old male subject with no information about the medical history who was supposed to have open heart surgery for an undisclosed cardiac disorder. No details were provided about previous mRNA-1273 vaccinations. The request for a booster vaccination makes it likely that 2 doses had been given before.   The benefit-risk relationship of mRNA-1273 was not affected by this report.