chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 79.0
Sex: F
Vaccine: COVID19
Symptoms: Expired product administered, Product storage error
Clinical narrative: Dose administered after exposure to room temperature  greater than 24 hours/dose was administered outside the standard time frame; Dose administered after exposure to room temperature greater than 24 hours; This spontaneous case was reported by a pharmacist and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Dose administered after exposure to room temperature  greater than 24 hours/dose was administered outside the standard time frame) and PRODUCT STORAGE ERROR (Dose administered after exposure to room temperature greater than 24 hours) in a 79-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 014B22A) for COVID-19 prophylaxis.     No Medical History information was reported.    On 19-Jul-2022 at 1:00 PM, the patient received fourth dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) .25 milliliter. On 18-Jul-2022 at 10:30 AM, the patient experienced PRODUCT STORAGE ERROR (Dose administered after exposure to room temperature greater than 24 hours). On 19-Jul-2022 at 1:00 PM, the patient experienced EXPIRED PRODUCT ADMINISTERED (Dose administered after exposure to room temperature  greater than 24 hours/dose was administered outside the standard time frame). At the time of the report, EXPIRED PRODUCT ADMINISTERED (Dose administered after exposure to room temperature  greater than 24 hours/dose was administered outside the standard time frame) and PRODUCT STORAGE ERROR (Dose administered after exposure to room temperature greater than 24 hours) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant drug was reported. It was reported that vial was taken out of the fridge on 18-Jul-2022 at 10:30 AM. It was also reported that vial did not undergo any temperature excursions.  Total amount of time the vial was exposed to room temperature range (8 degree celcius to 25 degree celcius is equal to 46 degree to 77 degree F) was reported as 27 hours approximately. No treatment medications were reported
Age: 83.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Immunisation reaction, Vaccination site discomfort, Vaccination site erythema, Vaccination site pain, Vaccination site pruritus
Clinical narrative: Patient had side effects after first booster/Lost  peace after first booster/Unhappy after first booster; Big red ring all around left shoulder after first booster; Skin on injection site hurts really bad after first booster; Feels something under the injection site skin on left arm /Devil moving under skin on the injection site after first booster; Itching left shoulder after first booster; This spontaneous case was reported by a patient and describes the occurrence of IMMUNISATION REACTION (Patient had side effects after first booster/Lost  peace after first booster/Unhappy after first booster), VACCINATION SITE PRURITUS (Itching left shoulder after first booster), VACCINATION SITE ERYTHEMA (Big red ring all around left shoulder after first booster), VACCINATION SITE PAIN (Skin on injection site hurts really bad after first booster) and VACCINATION SITE DISCOMFORT (Feels something under the injection site skin on left arm /Devil moving under skin on the injection site after first booster) in an 83-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 126, 032B21A and 044A21A) for COVID-19 vaccination.     No Medical History information was reported.   On 18-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 27-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 15-Apr-2022, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 15-Apr-2022, the patient experienced IMMUNISATION REACTION (Patient had side effects after first booster/Lost  peace after first booster/Unhappy after first booster) and VACCINATION SITE ERYTHEMA (Big red ring all around left shoulder after first booster). In April 2022, the patient experienced VACCINATION SITE PRURITUS (Itching left shoulder after first booster), VACCINATION SITE PAIN (Skin on injection site hurts really bad after first booster) and VACCINATION SITE DISCOMFORT (Feels something under the injection site skin on left arm /Devil moving under skin on the injection site after first booster). At the time of the report, IMMUNISATION REACTION (Patient had side effects after first booster/Lost  peace after first booster/Unhappy after first booster), VACCINATION SITE PRURITUS (Itching left shoulder after first booster) and VACCINATION SITE ERYTHEMA (Big red ring all around left shoulder after first booster) had not resolved and VACCINATION SITE PAIN (Skin on injection site hurts really bad after first booster) and VACCINATION SITE DISCOMFORT (Feels something under the injection site skin on left arm /Devil moving under skin on the injection site after first booster) outcome was unknown.            No concomitant information was reported. No treatment information was provided.
Age: 83.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Inappropriate schedule of product administration
Clinical narrative: Patient had side effects after first booster/Lost  peace after first booster/Unhappy after first booster; Big red ring all around left shoulder after first booster; Skin on injection site hurts really bad after first booster; Feels something under the injection site skin on left arm /Devil moving under skin on the injection site after first booster; Itching left shoulder after first booster; This spontaneous case was reported by a patient and describes the occurrence of IMMUNISATION REACTION (Patient had side effects after first booster/Lost  peace after first booster/Unhappy after first booster), VACCINATION SITE PRURITUS (Itching left shoulder after first booster), VACCINATION SITE ERYTHEMA (Big red ring all around left shoulder after first booster), VACCINATION SITE PAIN (Skin on injection site hurts really bad after first booster) and VACCINATION SITE DISCOMFORT (Feels something under the injection site skin on left arm /Devil moving under skin on the injection site after first booster) in an 83-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 126, 032B21A and 044A21A) for COVID-19 vaccination.     No Medical History information was reported.   On 18-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 27-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 15-Apr-2022, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 15-Apr-2022, the patient experienced IMMUNISATION REACTION (Patient had side effects after first booster/Lost  peace after first booster/Unhappy after first booster) and VACCINATION SITE ERYTHEMA (Big red ring all around left shoulder after first booster). In April 2022, the patient experienced VACCINATION SITE PRURITUS (Itching left shoulder after first booster), VACCINATION SITE PAIN (Skin on injection site hurts really bad after first booster) and VACCINATION SITE DISCOMFORT (Feels something under the injection site skin on left arm /Devil moving under skin on the injection site after first booster). At the time of the report, IMMUNISATION REACTION (Patient had side effects after first booster/Lost  peace after first booster/Unhappy after first booster), VACCINATION SITE PRURITUS (Itching left shoulder after first booster) and VACCINATION SITE ERYTHEMA (Big red ring all around left shoulder after first booster) had not resolved and VACCINATION SITE PAIN (Skin on injection site hurts really bad after first booster) and VACCINATION SITE DISCOMFORT (Feels something under the injection site skin on left arm /Devil moving under skin on the injection site after first booster) outcome was unknown.            No concomitant information was reported. No treatment information was provided.
Age: 83.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Immunisation reaction, Vaccination site discomfort, Vaccination site erythema, Vaccination site pain, Vaccination site pruritus
Clinical narrative: First dose on 18MAR2021, 2nd shot on 27APR2021; This spontaneous case was reported by a patient and describes the occurrence of INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (First dose on 18MAR2021, 2nd shot on 27APR2021) in an 83-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 032B21A and 044A21A) for COVID-19 prophylaxis.     No Medical History information was reported.   On 18-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 27-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 27-Apr-2021,  after starting mRNA-1273 (Moderna COVID-19 Vaccine), the patient experienced INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (First dose on 18MAR2021, 2nd shot on 27APR2021). At the time of the report, INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (First dose on 18MAR2021, 2nd shot on 27APR2021) outcome was unknown.            No concomitant medications were provided. No treatment medications were reported.   This case was linked to MOD-2022-610769 (Patient Link).
Age: 83.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Inappropriate schedule of product administration
Clinical narrative: First dose on 18MAR2021, 2nd shot on 27APR2021; This spontaneous case was reported by a patient and describes the occurrence of INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (First dose on 18MAR2021, 2nd shot on 27APR2021) in an 83-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 032B21A and 044A21A) for COVID-19 prophylaxis.     No Medical History information was reported.   On 18-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 27-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 27-Apr-2021,  after starting mRNA-1273 (Moderna COVID-19 Vaccine), the patient experienced INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (First dose on 18MAR2021, 2nd shot on 27APR2021). At the time of the report, INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (First dose on 18MAR2021, 2nd shot on 27APR2021) outcome was unknown.            No concomitant medications were provided. No treatment medications were reported.   This case was linked to MOD-2022-610769 (Patient Link).
Age: 30.0
Sex: M
Vaccine: COVID19
Symptoms: Expired product administered, Inappropriate schedule of product administration, SARS-CoV-2 test
Clinical narrative: second dose was  more than a months after his first dose, and it had expired on the 20May2022.; he received and expired vaccine for his second dose; This spontaneous case was reported by a patient and describes the occurrence of INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (second dose was  more than a months after his first dose, and it had expired on the 20May2022.) and EXPIRED PRODUCT ADMINISTERED (he received and expired vaccine for his second dose) in a 30-year-old male patient who received mRNA-1273 (Spikevax) (batch nos. 033K21-2A and 033K21-2A) for COVID-19 vaccination.     Concurrent medical conditions included Hay fever.   On 14-Feb-2022, the patient received first dose of mRNA-1273 (Spikevax) (Intramuscular) 1 dosage form. On 30-Jun-2022, received second dose of mRNA-1273 (Spikevax) (unknown route) dosage was changed to 1 dosage form. On 30-Jun-2022, the patient experienced INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (second dose was  more than a months after his first dose, and it had expired on the 20May2022.) and EXPIRED PRODUCT ADMINISTERED (he received and expired vaccine for his second dose). At the time of the report, INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (second dose was  more than a months after his first dose, and it had expired on the 20May2022.) and EXPIRED PRODUCT ADMINISTERED (he received and expired vaccine for his second dose) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, SARS-CoV-2 test: (Positive) Positive.         No concomitant medication was provided. No treatment medication were provided. No other vaccines were received by the patient within 1 month prior to Moderna COVID-19 vaccine. It was reported that patient had never experienced a similar event in the past. The AE did not cause patient to seek medical care (office visit, Urgent care, ER, hospitalized). The patient had COVID + test or diagnosis in Jan2022 or Dec2021.
Sex: U
Vaccine: COVID19
Symptoms: Adverse reaction
Clinical narrative: An adverse reaction; This spontaneous case was reported by a patient and describes the occurrence of ADVERSE REACTION (An adverse reaction) in a  patient of an unknown age and gender who received mRNA-1273 (Spikevax) for COVID-19 prophylaxis.     No Medical History information was reported.    On an unknown date, the patient received dose of mRNA-1273 (Spikevax) (unknown route) 1 dosage form. On an unknown date, the patient experienced ADVERSE REACTION (An adverse reaction). At the time of the report, ADVERSE REACTION (An adverse reaction) outcome was unknown.        The action taken with mRNA-1273 (Spikevax) (Unknown) was unknown.       No concomitant medications were reported.  No treatment medications were reported.
Age: 80.0
Sex: U
Vaccine: COVID19
Symptoms: Expired product administered
Clinical narrative: A dose of Moderna Covid-19 vaccine was administered to a patient at 10a today (21Jul2022) from a vial that was punctured at 11:45a on 20Jul2022; This spontaneous case was reported by a nurse and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (A dose of Moderna Covid-19 vaccine was administered to a patient at 10a today (21Jul2022) from a vial that was punctured at 11:45a on 20Jul2022) in an 80-year-old patient of an unknown gender who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 056M21A) for COVID-19 prophylaxis.     No Medical History information was reported.    On 21-Jul-2022 at 10:00 AM, the patient received fourth dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) .25 milliliter. On 21-Jul-2022 at 10:00 AM, the patient experienced EXPIRED PRODUCT ADMINISTERED (A dose of Moderna Covid-19 vaccine was administered to a patient at 10a today (21Jul2022) from a vial that was punctured at 11:45a on 20Jul2022). At the time of the report, EXPIRED PRODUCT ADMINISTERED (A dose of Moderna Covid-19 vaccine was administered to a patient at 10a today (21Jul2022) from a vial that was punctured at 11:45a on 20Jul2022) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant medications were reported. No treatment details were reported. Number of doses/vial was Single dose The vial was initially stored in the refrigerator on 14-Jul-2022 Vial was first punctured on 20-Jul-2022 at 11:45 am Vial was stored in the refrigeration post puncture Vial did not undergo any temperature excursions
Age: 19.0
Sex: F
Vaccine: COVID19
Symptoms: Expired product administered, Poor quality product administered, Product temperature excursion issue
Clinical narrative: vial undergo temperature excursions; Dose administered from vial undergo temperature excursions; administered expiry vaccine; This spontaneous case was reported by a nurse and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (administered expiry vaccine), PRODUCT TEMPERATURE EXCURSION ISSUE (vial undergo temperature excursions) and POOR QUALITY PRODUCT ADMINISTERED (Dose administered from vial undergo temperature excursions) in a 19-year-old female patient who received mRNA-1273 (Spikevax) (batch no. 004M21A) for COVID-19 prophylaxis.     No Medical History information was reported.    On 18-Jul-2022, the patient received first dose of mRNA-1273 (Spikevax) (unknown route) 1 dosage form. On 18-Jul-2022, the patient experienced EXPIRED PRODUCT ADMINISTERED (administered expiry vaccine). On an unknown date, the patient experienced PRODUCT TEMPERATURE EXCURSION ISSUE (vial undergo temperature excursions) and POOR QUALITY PRODUCT ADMINISTERED (Dose administered from vial undergo temperature excursions). At the time of the report, EXPIRED PRODUCT ADMINISTERED (administered expiry vaccine), PRODUCT TEMPERATURE EXCURSION ISSUE (vial undergo temperature excursions) and POOR QUALITY PRODUCT ADMINISTERED (Dose administered from vial undergo temperature excursions) outcome was unknown.        The action taken with mRNA-1273 (Spikevax) (Unknown) was unknown.   For mRNA-1273 (Spikevax) (Unknown), the reporter did not provide any causality assessments.   No concomitant medication were provided  It was reported that dose was administered from 3 vails after 30-day Use By Date or after manufacturer date of expiry. The vial was initially stored in the refrigerator on 17-Jul-2022,and 18-Jul-2022 and vial undergo temperature excursions.   Maximum of 5.8°F temperatures was reached and excursion took place for 15 minutes  While visual inspection it was noticed that vaccine were still frozen  No proposed desired Use by Date was provided.  No treatment details were provided.   This case was linked to MOD-2022-611877 (Patient Link).   Most recent FOLLOW-UP information incorporated above includes: On 21-Jul-2022: Follow up received included non significant information (reporter's last name and email address updated).
Sex: U
Vaccine: COVID19
Symptoms: Vaccination complication
Clinical narrative: developed since then at some pretty severe mobile form on left side; This spontaneous case was reported by a patient and describes the occurrence of VACCINATION COMPLICATION (developed since then at some pretty severe mobile form on left side) in a  patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 prophylaxis.     No Medical History information was reported.   In 2022, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. In 2022, the patient experienced VACCINATION COMPLICATION (developed since then at some pretty severe mobile form on left side). At the time of the report, VACCINATION COMPLICATION (developed since then at some pretty severe mobile form on left side) outcome was unknown.      No concomitant medications were reported.  Patient was recent recipient of COVID booster.   No treatment medications were reported.
Age: 28.0
Sex: F
Vaccine: COVID19
Symptoms: Expired product administered, Product storage error
Clinical narrative: Vial was stored in refrigerator on 16-Jun-2022 and administered on 18-Jul-2022; Vaccine administered 30 days after beyond use date; This spontaneous case was reported by a nurse and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Vaccine administered 30 days after beyond use date) and PRODUCT STORAGE ERROR (Vial was stored in refrigerator on 16-Jun-2022 and administered on 18-Jul-2022) in a 28-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 037a22b) for COVID-19 prophylaxis.     No Medical History information was reported.    On 18-Jul-2022, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 18-Jul-2022, the patient experienced EXPIRED PRODUCT ADMINISTERED (Vaccine administered 30 days after beyond use date). On an unknown date, the patient experienced PRODUCT STORAGE ERROR (Vial was stored in refrigerator on 16-Jun-2022 and administered on 18-Jul-2022). At the time of the report, EXPIRED PRODUCT ADMINISTERED (Vaccine administered 30 days after beyond use date) and PRODUCT STORAGE ERROR (Vial was stored in refrigerator on 16-Jun-2022 and administered on 18-Jul-2022) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant medication was reported by reporter.  Patient had received second booster on 18-Jul-2022.  Number of doses and vials were reported as 6 doses from the same vial 3. The vials were stored in refrigerator on 16-Jun-2022. The vial did not undergo any temperature excursions.  No treatment medication was reported by reporter.
Age: 73.0
Sex: F
Vaccine: COVID19
Symptoms: Expired product administered, Product storage error
Clinical narrative: Vial was stored in refrigerator on 16-Jun-2022 and administered on 18-Jul-2022; Vaccine administered 30 days after beyond use date; This spontaneous case was reported by a nurse and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Vaccine administered 30 days after beyond use date) and PRODUCT STORAGE ERROR (Vial was stored in refrigerator on 16-Jun-2022 and administered on 18-Jul-2022) in a 73-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 037a22b) for COVID-19 prophylaxis.     No Medical History information was reported.    On 18-Jul-2022, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 18-Jul-2022, the patient experienced EXPIRED PRODUCT ADMINISTERED (Vaccine administered 30 days after beyond use date). On an unknown date, the patient experienced PRODUCT STORAGE ERROR (Vial was stored in refrigerator on 16-Jun-2022 and administered on 18-Jul-2022). At the time of the report, EXPIRED PRODUCT ADMINISTERED (Vaccine administered 30 days after beyond use date) and PRODUCT STORAGE ERROR (Vial was stored in refrigerator on 16-Jun-2022 and administered on 18-Jul-2022) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant medication was reported by reporter.  Patient had received second booster on 18 Jul 2022.  Number of doses and vials were reported as 6 doses from the same vial 3. The vials were stored in refrigerator on 16 Jun 2022. The vial did not undergo any temperature excursions.  No treatment medication was reported by reporter.
Age: 60.0
Sex: M
Vaccine: COVID19
Symptoms: Expired product administered, Product storage error, Product temperature excursion issue
Clinical narrative: They have a temperature excursion on 04Jun2022; Vial expired on 13-Jul-2022 and refrigerated on 17Jul2022 and 18Jul2022; administer expiry vaccine to 5 patients; This spontaneous case was reported by a nurse and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (administer expiry vaccine to 5 patients), PRODUCT TEMPERATURE EXCURSION ISSUE (They have a temperature excursion on 04Jun2022) and PRODUCT STORAGE ERROR (Vial expired on 13-Jul-2022 and refrigerated on 17Jul2022 and 18Jul2022) in a 60-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 004M21A) for COVID-19 prophylaxis.     Previously administered products included for Product used for unknown indication: Johnson & Johnson in April 2021. Past adverse reactions to the above products included No adverse event with Johnson & Johnson.   On 22-Nov-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 19-Jul-2022, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 19-Jul-2022, the patient experienced EXPIRED PRODUCT ADMINISTERED (administer expiry vaccine to 5 patients). On an unknown date, the patient experienced PRODUCT TEMPERATURE EXCURSION ISSUE (They have a temperature excursion on 04Jun2022) and PRODUCT STORAGE ERROR (Vial expired on 13-Jul-2022 and refrigerated on 17Jul2022 and 18Jul2022). At the time of the report, EXPIRED PRODUCT ADMINISTERED (administer expiry vaccine to 5 patients), PRODUCT TEMPERATURE EXCURSION ISSUE (They have a temperature excursion on 04Jun2022) and PRODUCT STORAGE ERROR (Vial expired on 13-Jul-2022 and refrigerated on 17Jul2022 and 18Jul2022) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant medication was reported by reporter. It was reported that during time of excursion (maximum 5.8 degree F) for 15min vials were in frozen storage. 3 affected vials were stored in refrigerator on 17-Jul-2022 and 18-Jul-2022. Currently those vials were wasted and 1 vial was stored in the freezer. Vaccines did not have a change in state and were still frozen. No treatment medication was reported by reporter.   This case was linked to US-MODERNATX, INC.-MOD-2022-611848, US-MODERNATX, INC.-MOD-2022-611864, US-MODERNATX, INC.-MOD-2022-611805, US-MODERNATX, INC.-MOD-2022-611877 (Linked Report).   Most recent FOLLOW-UP information incorporated above includes: On 21-Jul-2022: Live follow-up received contains non significant information.; Sender's Comments:  US-MODERNATX, INC.-MOD-2022-611848:Patient 2 US-MODERNATX, INC.-MOD-2022-611864:Patient 4 US-MODERNATX, INC.-MOD-2022-611805:Patient 1 US-MODERNATX, INC.-MOD-2022-611877:Patient 5
Age: 64.0
Sex: F
Vaccine: COVID19
Symptoms: Expired product administered, Product storage error, Product temperature excursion issue
Clinical narrative: Temperature excursion; Product got expired on 13-Jul-2022 and store in refrigerator on 17-Jul-2022; Administer expiry vaccine; This spontaneous case was reported by a nurse and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Administer expiry vaccine), PRODUCT TEMPERATURE EXCURSION ISSUE (Temperature excursion) and PRODUCT STORAGE ERROR (Product got expired on 13-Jul-2022 and store in refrigerator on 17-Jul-2022) in a 64-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 004M21A) for COVID-19 prophylaxis.     No Medical History information was reported.   On 13-Apr-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 19-Jul-2022, received fourth 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, received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 19-Jul-2022, the patient experienced EXPIRED PRODUCT ADMINISTERED (Administer expiry vaccine). On an unknown date, the patient experienced PRODUCT TEMPERATURE EXCURSION ISSUE (Temperature excursion) and PRODUCT STORAGE ERROR (Product got expired on 13-Jul-2022 and store in refrigerator on 17-Jul-2022). At the time of the report, EXPIRED PRODUCT ADMINISTERED (Administer expiry vaccine), PRODUCT TEMPERATURE EXCURSION ISSUE (Temperature excursion) and PRODUCT STORAGE ERROR (Product got expired on 13-Jul-2022 and store in refrigerator on 17-Jul-2022) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   It was reported that five patients received vaccination which has undergone temperature excursion. Dates of administration of vaccine was 18-Jul2-022 and 19-Jul-2022. The vial was initially stored in the refrigerator on 17-Jul-2022 and 18-Jul-2022.The maximum temperatures reached at a maximum of 5.8°F. The vial undergone a temperature excursions duration of 15 minutes.The vials were  moved from freezer to refrigerator on  17-Jul-2022 and 18-Jul-2022. On visual inspection there was no change in state of vaccine.   This case was linked to MOD-2022-611805, MOD-2022-611848, MOD-2022-611864 (Patient Link).   Most recent FOLLOW-UP information incorporated above includes: On 21-Jul-2022: Follow-up Received: Reporter email address, last name updated.
Age: 59.0
Sex: M
Vaccine: COVID19
Symptoms: Acoustic neuroma, Computerised tomogram abnormal, Deafness unilateral, Magnetic resonance imaging normal, Sudden hearing loss
Clinical narrative: Sudden Hearing Loss/Left Ear 04-05-2022 Oral Steroids prescribed by Clinic- (for Hearing disorders) 04-28-2022 Hyperbaric Oxygen treatments-05-21-2022 (30-straight days of 1-1/2  hour sessions)
Age: 32.0
Sex: F
Vaccine: COVID19
Symptoms: Blood iron decreased, Blood test, Chest discomfort, Chest pain, Dizziness
Clinical narrative: Extreme blood loss during menstrual cycle resulting in two hospitalizations and two separate blood transfusions. Two bags of blood needed both visits within 60 days of each other. 1st cycle bled for 30 days before being hospitalized the 2nd cycle bled so much I nearly passed out.  I had never had menstrual cycles this bad until after the vaccine. Infact I have little to very infrequent periods. Symptoms were extreme fatigue lightheadedness chest pain/pressure difficulty breathing and headache and pressure that lasted for dead. Bleeding through a maxi pad every 2 hrs for 7 days.  1st hospital stay was regional hospital, 2nd was at a different hospital
Age: 32.0
Sex: F
Vaccine: COVID19
Symptoms: Dyspnoea, Fatigue, Haemoglobin decreased, Head discomfort, Headache
Clinical narrative: Extreme blood loss during menstrual cycle resulting in two hospitalizations and two separate blood transfusions. Two bags of blood needed both visits within 60 days of each other. 1st cycle bled for 30 days before being hospitalized the 2nd cycle bled so much I nearly passed out.  I had never had menstrual cycles this bad until after the vaccine. Infact I have little to very infrequent periods. Symptoms were extreme fatigue lightheadedness chest pain/pressure difficulty breathing and headache and pressure that lasted for dead. Bleeding through a maxi pad every 2 hrs for 7 days.  1st hospital stay was regional hospital, 2nd was at a different hospital
Age: 32.0
Sex: F
Vaccine: COVID19
Symptoms: Heavy menstrual bleeding, Transfusion, Ultrasound scan
Clinical narrative: Extreme blood loss during menstrual cycle resulting in two hospitalizations and two separate blood transfusions. Two bags of blood needed both visits within 60 days of each other. 1st cycle bled for 30 days before being hospitalized the 2nd cycle bled so much I nearly passed out.  I had never had menstrual cycles this bad until after the vaccine. Infact I have little to very infrequent periods. Symptoms were extreme fatigue lightheadedness chest pain/pressure difficulty breathing and headache and pressure that lasted for dead. Bleeding through a maxi pad every 2 hrs for 7 days.  1st hospital stay was regional hospital, 2nd was at a different hospital
Age: 52.0
Sex: M
Vaccine: COVID19, COVID19, COVID19
Symptoms: Audiogram, Bell's palsy, Blood test, COVID-19, Computerised tomogram
Clinical narrative: Bells Palsy on 05/01/2022, treated with steroid over five day period. Loss of hearing, 30%Loss unexplainable irritation to audio nerves and facial disruption.  Covid, contracted twice
Age: 52.0
Sex: M
Vaccine: COVID19, COVID19, COVID19
Symptoms: Deafness, Facial nerve disorder, Magnetic resonance imaging, Nervous system disorder
Clinical narrative: Bells Palsy on 05/01/2022, treated with steroid over five day period. Loss of hearing, 30%Loss unexplainable irritation to audio nerves and facial disruption.  Covid, contracted twice
Age: 68.0
Sex: M
Vaccine: COVID19
Symptoms: Cerebrovascular accident, Computerised tomogram, Echocardiogram, Magnetic resonance imaging
Clinical narrative: Stroke on 06/30/2022. - no family history of stroke.
Age: 62.0
Sex: F
Vaccine: VARZOS
Symptoms: Chills, Dizziness, Headache, Sinus disorder
Clinical narrative: Chills headache sinus issues dizzy
Age: 7.0
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, SARS-CoV-2 test, Vaccination failure
Clinical narrative: contracted COVID-19/got vaccinated still tested positive for covid19 afterwards; contracted COVID-19/got vaccinated still tested positive for covid19 afterwards; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP) from medical information team, Program ID: (005570). The reporter is the parent.  A 7-year-old female patient received BNT162b2 (BNT162B2), on 04Nov2021 as dose 1, single (Lot number: FK5127, Expiration Date: 03Dec2021), on 23Nov2021 as dose 2, single (Lot number: FK5127, Expiration Date: 03Dec2021) and on 23May2022 as dose 3 (booster), single (Lot number: FL0007) at the age of 7 years for covid-19 immunisation. The patient's relevant medical history was not reported. There were no concomitant medications. The following information was reported: VACCINATION FAILURE (medically significant), COVID-19 (medically significant) all with onset 05Jul2022, outcome "not recovered" and all described as "contracted COVID-19/got vaccinated still tested positive for covid19 afterwards". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (05Jul2022) Positive, notes: vaccinated still tested positive for covid19 afterwards: tested positive on 05Jul2022. Clinical information: The reporter stated that, the reporter was mother of 4 and part time acute care speech language pathologist. The reporter and her family (husband and 4 children (Ages 5,5 (twins), 7, and 9)) were vaccinated and twice boosted to lessen severe illness from a COVID-19 infection. The family contracted COVID-19, likely July3. Only one of the five-year-old has remained negative via at home antigen testing. The reporter asked if there were any studies that they could participate in and assist. There were no other products. There were no additional vaccines administered on same date. No prior vaccinations (within 4 weeks). No AE(s) following prior vaccinations. The reporter assessed the event as non-serious.; Sender's Comments: Linked Report(s) : US-PFIZER INC-PV202200021017 Same reporter/vaccine/event, different patient.;
Sex: F
Vaccine: COVID19, COVID19
Symptoms: COVID-19, Drug ineffective
Clinical narrative: Treatment of COVID-19; Treatment of COVID-19; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 22-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), as dose 2, single (Batch/Lot number: unknown) for covid-19 immunization. coviD-19 vaccine (COVID-19 VACCINE), as dose 1, single (Batch/Lot number: unknown) for covid-19 immunization. The patient had no relevant medical history. Concomitant medication(s) included: BUSPIRONE; ARIPIPRAZOLE; FLUOXETINE. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant) all with onset 2022, outcome "unknown" and all described as "Treatment of COVID-19".  The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.
Sex: U
Vaccine: COVID19
Symptoms: Obesity, Thyroid disorder, Weight
Clinical narrative: I got the 2 Pfizer shots; I have thyroid and I am obese; I got the 2 Pfizer shots; I have thyroid and I am obese; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 62-year-old patient received BNT162b2 (BNT162B2), as dose 2, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: Bnt162b2 (Dose:1,  I got the 2 Pfizer shots), for Covid-19 immunization. The following information was reported: THYROID DISORDER (non-serious), OBESITY (non-serious), outcome "unknown" and all described as "I got the 2 Pfizer shots; I have thyroid and I am obese". Relevant laboratory tests and procedures are available in the appropriate section. Additional information: Reporter reported that I have thyroid and I am obese, like I am 200 something. I'm considered obese like I'm overweight. I am 62 years old, and I got the 2 Pfizer shots, I was okay with it. Now, I want to go for the booster shot. How many months after the 2nd shot, I need to go get the booster? I have been hearing like from people who ever got this shot the booster, they have been experiencing like numbness in their fingertip's hands and the feet, they've been experiencing that is that normal? Like I am afraid to have booster shot.  Follow-up attempts are completed. No further information is expected.
Age: 63.0
Sex: F
Vaccine: COVID19
Symptoms: Acoustic stimulation tests, Deafness unilateral, Ear, nose and throat examination, Tinnitus
Clinical narrative: lost some hearing in the left ear; ringing in my left ear/tinnitus; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 63-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 02Apr2021 at 14:15 as dose 1, single (Lot number: ER8737) and on 24Apr2021 at 10:30 as dose 2, single (Lot number: EW0170) at the age of 63 years, in right arm for covid-19 immunisation. The patient's relevant medical history included: "Hypothyrodism" (unspecified if ongoing). Patient had no known allergies. Concomitant medication(s) included: ATORVASTATIN; BIOTIN; CALCIUM; LEVOTHYROXINE. The following information was reported: DEAFNESS UNILATERAL (disability, medically significant) with onset 07Jun2021 at 14:00, outcome "not recovered", described as "lost some hearing in the left ear"; TINNITUS (disability) with onset 07Jun2021 at 14:00, outcome "not recovered", described as "ringing in my left ear/tinnitus". The events "lost some hearing in the left ear" and "ringing in my left ear/tinnitus" required physician office visit. The patient underwent the following laboratory tests and procedures: Acoustic stimulation tests: (unspecified date) lost some hearing in the left ear, notes: He also performed an extensive hearing test and I have lost some hearing in the left ear; Ear, nose and throat examination: (05Oct2021) tinnitus. Therapeutic measures were not taken as a result of deafness unilateral, tinnitus.  Clinical course: Patient had ringing in left ear within two months of first covid vaccine. Patient had an ENT confirm in an appt on 05Oct2021 that patient has tinnitus. He also performed an extensive hearing test and patient have lost some hearing in the left ear. Patient also received BNT162b2 (BNT162B2), on 22Dec2021 at 12:30 PM as dose 3 (Booster), single (Lot number: FL3197) in left arm for COVID-19 immunization. Since booster shot on 22Dec2021, the ringing in patient's left ear has gotten worse and louder. Adverse event resulted in doctor or other healthcare professional office/clinic visit, disability or permanent damage. Patient received no other vaccine in four weeks. Patient had no covid prior vaccination. Patient was not covid tested post vaccination. Follow-up attempts are completed. No further information is expected.
Sex: U
Vaccine: COVID19
Symptoms: Overdose
Clinical narrative: possibly administered that adult vaccine to an 8 year old patient/administration of the Pfizer Covid19 vaccine grey cap to an 8 year old patient; The initial case was missing the following minimum criteria: Unspecified AE. Upon receipt of follow-up information on 12Jul2022, this case now contains all required information to be considered valid.  This is a spontaneous report received from a contactable reporter(s) (Nurse) from medical information team, Program ID: (159558).  An 8-year-old patient received BNT162b2 (COMIRNATY), as dose number unknown, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: OVERDOSE (non-serious), outcome "unknown", described as "possibly administered that adult vaccine to an 8 year old patient/administration of the Pfizer Covid19 vaccine grey cap to an 8 year old patient".  Additional information: The caller called about the Pfizer Covid19 vaccine grey cap and a nurse possibly administered that adult vaccine to an 8 year old patient; caller clarified that he did not have patient information or date of birth.  The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.
Age: 69.0
Sex: M
Vaccine: COVID19
Symptoms: Acne, Biopsy, Psoriasis, Rash, Skin infection
Clinical narrative: infection that spread to my groin and was big in area; a rash on my butt; pimples; Psoriasis; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 69-year-old male patient received BNT162b2 (BNT162B2), on 29Oct2021 at 13:00 as dose 3 (booster), single (Lot number: ph8028) at the age of 69 years, in right arm for covid-19 immunisation. The patient's relevant medical history was not reported. There were no concomitant medications. Past drug history included: Lisinopril, reaction(s): "known allergies: Lisinopril". Vaccination history included: BNT162b2 (DOSE 2, SINGLE, lot number: EN6208,, Administration time: 01:00 PM,, Anatomical location: Right arm), administration date: 15Mar2021, when the patient was 69-year-old, for COVID-19 immunization; BNT162b2 (DOSE 1, SINGLE, Lot number: En6201, Administration time: 01:00 PM, Anatomical location: Left arm), administration date: 22Feb2021, when the patient was 69-year-old, for COVID-19 immunization. The following information was reported: PSORIASIS (non-serious) with onset 04Nov2021, outcome "not recovered"; RASH (non-serious) with onset 04Nov2021, outcome "not recovered", described as "a rash on my butt"; SKIN INFECTION (non-serious) with onset 04Nov2021, outcome "not recovered", described as "infection that spread to my groin and was big in area"; ACNE (non-serious) with onset 04Nov2021, outcome "not recovered", described as "pimples". The events "infection that spread to my groin and was big in area", "a rash on my butt", "pimples" and "psoriasis" required physician office visit. Relevant laboratory tests and procedures are available in the appropriate section. Therapeutic measures were taken as a result of skin infection, rash, acne, psoriasis.  Additional information: Patient reported ''Days after the booster had a rash on my butt, turned into an infection that spread to my groin and was big in area. (photos available). At the same time had some strange growths, pimples, one large area that Dr (Name withheld) took a biopsy, Psoriasis. Took moths of appointments, trying different remedies. 24Jun started Tremfya $8000 out of pocket for a years treatment. For 69 years, no skin problems or infections and no Family history, talked to 5 of my siblings''. AE treatment included Creams, Ointments, Something for infections and now. No other medical history. No covid prior vaccination. Covid was not tested post vaccination.   Follow-up attempts are completed. No further information is expected.
Age: 75.0
Sex: F
Vaccine: COVID19
Symptoms: Peripheral swelling, Thrombosis, Ultrasound testes
Clinical narrative: leg is still swollen; Blood Clot; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 75-year-old female patient received BNT162b2 (BNT162B2), on 23Feb2021 as dose 1, single (Lot number: EN6202), in left arm and on 16Mar2021 as dose 2, single (Lot number: EN6206) at the age of 75 years, in left arm for covid-19 immunisation. The patient's relevant medical history included: "her sinus gets backed up" (unspecified if ongoing), notes: Allergies: She has no specific allergy, her sinus gets backed up but there's nothing specific that she is allergic to. There were no concomitant medications. The following information was reported: THROMBOSIS (medically significant) with onset Nov2021, outcome "not recovered", described as "Blood Clot"; PERIPHERAL SWELLING (non-serious), outcome "not recovered", described as "leg is still swollen". The events "blood clot" and "leg is still swollen" required physician office visit. The patient underwent the following laboratory tests and procedures: Ultrasound testes: (Nov2021) Blood Clot, notes: Result: Blood Clot;  Unit: Not Provided.  Clinical information: When probed for what product she was calling about, the caller states that she had got her card with the vaccination on it, it's a vaccination record card, she got 2 doses. Caller clarified that it was the vaccine for covid. Caller states that she was calling because she had a side effect after the vaccine, she had a Blood clot, she had a blood clot in her leg and she didn't have that before the vaccine. Email: Decline. The Blood Clot was detect in Nov2021, it was right before the holiday, she didn't have one before the vaccine. HCP: Caller states that she had a doctor that she was now seeing. She didn't think about the blood clot, she having this blood clot for 6-7 months now, the blood clot was just not going away, that was why she called to find out if this is a side effect of covid, she didn't think about this till just this month. Caller did not want the doctor to be contacted. The Blood Clot was in the left leg groin area, when probed for the outcome she responds that her Leg was still swollen, it had been swollen since, it had not gone down at all. It was still the same. She got the vaccines in the Left arm, for both vaccine. Investigation: Yes, it started before the holiday, she had an Ultrasound of the Left leg Before the holiday. She did not know the specific date. She had no specific allergy, her sinus gets backed up but there's nothing specific that she was allergic to. Caller declined being transferred to the other department at the moment, stating that she would like to think about this. first.  Follow-up attempts are completed. No further information is expected.
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, Drug ineffective
Clinical narrative: Paxlovid indication=Treatment of COVID-19; Paxlovid indication=Treatment of COVID-19; This is a spontaneous report received from a contactable reporter(s) (Other HCP).  A 56-year-old female patient received BNT162b2 (BNT162B2), as dose number unknown, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant), outcome "unknown" and all described as "Paxlovid indication=Treatment of COVID-19". Therapeutic measures were taken as a result of drug ineffective, covid-19. Additional information: Anti-viral details: Paxlovid, Treatment start date: 28Jun2022, Treatment stop date: 03Jul2022, Indication: Treatment of COVID-19, Oral, rebound infection, If treatment ae: No.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.; Sender's Comments: Based on the information provided in the narrative, a causal association between the suspect drug and the eventS cannot be completely excluded.