chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Sex: F
Vaccine: VARZOS, VARZOS
Symptoms: Herpes zoster, Vaccination failure
Clinical narrative: Still experiencing Shingles outbreaks after completing Shingrix series; Still experiencing Shingles outbreaks after completing Shingrix series; This case was reported by a consumer via call center representative and described the occurrence of vaccination failure in a female patient who received Herpes zoster (Shingrix) for prophylaxis.   Co-suspect products included Herpes zoster (Shingrix) for prophylaxis.   Concurrent medical conditions included immunocompromised.   On an unknown date, the patient received the 2nd dose of Shingrix and the 1st dose of Shingrix. On an unknown date, several years after receiving Shingrix and Shingrix, the patient experienced vaccination failure (serious criteria GSK medically significant) and shingles. On an unknown date, the outcome of the vaccination failure and shingles were unknown.   It was unknown if the reporter considered the vaccination failure and shingles to be related to Shingrix and Shingrix.     Additional Information: GSK Receipt Date: 19-APR-2022 Reporter's Comments:  The reporter was the patient. The reported completed 2 dose Shingrix series several years ago. The patient still experiencing Shingles outbreaks after completing Shingrix series. The patient believed that they were immunocompromised had contributed to the recurring Shingels outbreak, despite being vaccinated. The reporter did not consent to follow-up. Additional Supportive Information: The case was considered as suspected vaccination failure since the details regarding the laboratory confirmation was not reported.
Age: 0.58
Sex: M
Vaccine: TDAP
Symptoms: Product administered to patient of inappropriate age
Clinical narrative: Boostrix administered to 7 month old; This case was reported by a nurse via call center representative and described the occurrence of inappropriate age at vaccine administration in a 7-month-old male patient who received DTPa (Reduced antigen) (Boostrix) for prophylaxis.   On 20th April 2022, the patient received the 1st dose of Boostrix. On 20th April 2022, unknown after receiving Boostrix, the patient experienced inappropriate age at vaccine administration. On an unknown date, the outcome of the inappropriate age at vaccine administration was unknown.   Additional Information: GSK Receipt Date: 20-APR-2022 Reporter's Comments: Nurse reported a 7 month old baby was administered Boostrix, which led to inappropriate age at vaccine administration. No vaccine information was provided. The Vaccine Administration Facility was the same as Primary Reporter. The reporter consented to follow up.
Sex: F
Vaccine: MENB
Symptoms: Wrong product administered
Clinical narrative: Administered Bexsero instead of Menactra; This case was reported by a nurse via call center representative and described the occurrence of wrong vaccine administered in a 17-year-old female patient who received Men B NVS (Bexsero) (batch number ABXB37AA, expiry date 31st July 2022) for prophylaxis.   Co-suspect products included meningococcal B recom vaccine + aloh + omv pre-filled syringe device (Bexsero Pre-Filled Syringe Device) injection syringe for prophylaxis.   On 15th April 2022, the patient received the 1st dose of Bexsero and Bexsero Pre-Filled Syringe Device. On 15th April 2022, unknown after receiving Bexsero and Bexsero Pre-Filled Syringe Device, the patient experienced wrong vaccine administered. On an unknown date, the outcome of the wrong vaccine administered was unknown.     This report is made by GSK without prejudice and does not imply any admission or liability for the incident or its consequences.   Additional Information: GSK Receipt Date: 20-APR-2022 Reporter's Comments: The nurse reported that patient came in to clinic saying she needed meningitis vaccine. Nurse administered Bexsero because there was no immunization record indicating patient had ever had any meningitis vaccine. The patient's mother called wanted to know why the school said it was the wrong vaccine, that she should have received the 2nd dose of Menactra. The reporter consented to follow up. Additional Supportive information: The patient received Bexsero instead of Menactra which led to wrong vaccine used.
Age: 27.0
Sex: F
Vaccine: TDAP
Symptoms: Expired product administered
Clinical narrative: administered an expired dose; This case was reported by a other health professional via call center representative and described the occurrence of expired vaccine used in a 27-year-old female patient who received DTPa (Reduced antigen) (Boostrix) (batch number 4374P, expiry date 2nd April 2022) for prophylaxis.   On 20th April 2022, the patient received Boostrix. On 20th April 2022, unknown after receiving Boostrix, the patient experienced expired vaccine used. On an unknown date, the outcome of the expired vaccine used was unknown.       Additional Information: GSK Receipt Date: 20-APR-2022 Reporter's Comments: The medical assistant reported that she administered an expired dose of Boostrix to patient. At time of reporting, repeat dose had not been administered. The reporter consented to follow up. Additional Supportive information:  The patient received vaccine which was already expired which led to expired vaccine used.
Sex: U
Vaccine: HIBV
Symptoms: Product storage error
Clinical narrative: Hiberix in freezer, then administered to patient; This case was reported by a other health professional via call center representative and described the occurrence of incorrect storage of drug in a patient who received Hib (Hiberix) for prophylaxis.   On an unknown date, the patient received Hiberix. On an unknown date, unknown after receiving Hiberix, the patient experienced incorrect storage of drug. On an unknown date, the outcome of the incorrect storage of drug was unknown.   Additional Information: GSK Receipt Date: 21-APR-2022  Reporter's Comments: Health care professional reported that a nurse from the facility stored a Hiberix box in the freezer and then administered one of these doses to a patient. The professional did not had any information about the lowest temperature the vaccine was exposed at, or any sort of information about lot number and expiration date, or any information about the patient The reporter consented to follow up.
Age: 18.0
Sex: F
Vaccine: MENB
Symptoms: Expired product administered
Clinical narrative: Patient received expired dose; This case was reported by a other health professional via call center representative and described the occurrence of expired vaccine used in a 18-year-old female patient who received Men B NVS (Bexsero) (batch number abxA87az, expiry date 31st January 2022) for prophylaxis.   Co-suspect products included meningococcal B recom vaccine + aloh + omv pre-filled syringe device (Bexsero Pre-Filled Syringe Device) injection syringe for prophylaxis.   On 9th March 2022, the patient received Bexsero and Bexsero Pre-Filled Syringe Device. On 9th March 2022, unknown after receiving Bexsero and Bexsero Pre-Filled Syringe Device, the patient experienced expired vaccine used. On an unknown date, the outcome of the expired vaccine used was unknown.   This report is made by GSK without prejudice and does not imply any admission or liability for the incident or its consequences.   Additional Information: GSK Receipt Date: 21-APR-2022 Reporter's Comment: The patient received an expired dose of Bexsero. The reporter consented to follow-up. Additional Supportive Information:  The patient received a dose of Bexsero which was already expired, which led to expired vaccine used. This is one of 3 cases, reported by the same reporter.; Sender's Comments:  US-GLAXOSMITHKLINE-US2022068142:Same reporter. US-GLAXOSMITHKLINE-US2022068148:Same reporter.
Age: 41.0
Sex: F
Vaccine: COVID19
Symptoms: Expired product administered, Product storage error
Clinical narrative: Date and time the vial was initially stored in the refrigerator on 25Feb2022 and date administered on 06Apr2022; Dose administered after 30-day Use By Date or after manufacturer date of expiry; This spontaneous case was reported by a nurse and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Dose administered after 30-day Use By Date or after manufacturer date of expiry) and PRODUCT STORAGE ERROR (Date and time the vial was initially stored in the refrigerator on 25Feb2022 and date administered on 06Apr2022) in a 41-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 027L21A) for COVID-19 vaccination.     Patient had no known allergies.  The patient's past medical history included Torticollis. Concomitant products included ESZOPICLONE (LUNESTA), VILAZODONE HYDROCHLORIDE (VIIBRYD), PREGABALIN (LYRICA), ALBUTEROL SULFATE, CETIRIZINE HCL, NAPROXEN and CYCLOBENZAPRINE for an unknown indication.    On 06-Apr-2022 at 2:57 PM, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 06-Apr-2022, the patient experienced EXPIRED PRODUCT ADMINISTERED (Dose administered after 30-day Use By Date or after manufacturer date of expiry). On an unknown date, the patient experienced PRODUCT STORAGE ERROR (Date and time the vial was initially stored in the refrigerator on 25Feb2022 and date administered on 06Apr2022). At the time of the report, EXPIRED PRODUCT ADMINISTERED (Dose administered after 30-day Use By Date or after manufacturer date of expiry) and PRODUCT STORAGE ERROR (Date and time the vial was initially stored in the refrigerator on 25Feb2022 and date administered on 06Apr2022) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   The vial did not undergo any temperature excursions. The patient had not experienced any side effects yet. Treatment medications were not reported
Sex: M
Vaccine: COVID19
Symptoms: Application site vesicles
Clinical narrative: WATER BLISTERS AFTER REMOVING THE BANDAGE; This spontaneous report received from a consumer via a company representative concerned a male of unspecified age, race and ethnicity. The patient's height, and weight were not reported. No past medical history or concurrent conditions were reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin was not reported, batch number: unknown, expiry: unknown) 1 total, dose, start therapy date were not reported for prophylactic vaccination. The batch number was not reported. The Company is unable to perform follow-up to request batch/lot numbers. The patient received band aid skin flex (form of admin, route of admin were not reported, batch number: unknown, expiry: unknown) dose, start therapy date were not reported for an unspecified indication. No concomitant medications were reported. On an unspecified date, the patient had water blisters after removing the bandage. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of water blisters after removing the bandage was not reported. This report was non-serious.
Sex: U
Vaccine: COVID19, COVID19
Symptoms: Vaccination failure, Vaccine breakthrough infection
Clinical narrative: BREAKTHROUGH INFECTION; CONFIRMED CLINICAL VACCINATION FAILURE; This spontaneous report was received from literature. This report concerned multiple patients (3 patients) of unspecified sex, age, race and ethnicity. No past medical history or concurrent conditions were reported. The patients received covid-19 vaccine ad26.cov2.s (dose number in series 1) (suspension for injection, route of admin not reported, batch number: Unknown and expiry: Unknown) dose, primary dose, start therapy date were not reported, 1 total administered for prophylactic vaccination. The batch number was not reported. Per procedure, no follow-up will be requested for this case. No concomitant medications were reported. The patients additionally received non-company suspect vaccine included: MRNA 1273 (elasomeran) (dose number in series 2) (form of admin, route of admin not reported, batch number: Unknown and expiry: Unknown), dose, start therapy date were not reported for prophylactic vaccination. On an unspecified date, the patients had confirmed clinical vaccination failure (dose number in series 1). It was reported that the patient had breakthrough infection after 60 days of booster shot, MRNA 1273 (elasomeran). The days between symptom onset and blood draw was 16 days. The second patient was administered the booster dose of MRNA 1273 (elasomeran), and 50 days after the booster shot patient had breakthrough infection. The days between symptom onset and blood draw was 7 days. It was also reported that the third patient also had breakthrough infection in 34 days after received booster dose of MRNA 1273 (elasomeran). The days between symptom onset and blood draw was 10 days. (dose number in series 2). The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the breakthrough infection and confirmed clinical vaccination failure was not reported. It was concluded the data suggest that breakthrough infection with the Omicron variant can occur despite robust immune responses to the vaccine strain spike protein. This report was serious (Other Medically Important Condition). This report was associated with product quality complaint and reference number requested.; Sender's Comments: V0: 20220430845- covid-19 vaccine ad26.cov2.s-confirmed clinical vaccination failure . The event(s) has an unknown/unclear temporal relationship, is unlabeled, and has unknown scientific plausibility. There are other factors more likely to be associated with the event(s) than the drug. Specifically: SPECIAL SITUATIONS. Therefore, this event(s) is considered not related. 20220430845- covid-19 vaccine ad26.cov2.s - breakthrough  infection. The event(s) has an unknown/unclear temporal relationship, is unlabeled, and has unknown scientific plausibility. There is no information on any other factors potentially associated with the event(s). Therefore, this event(s) is considered unassessable.
Sex: M
Vaccine: COVID19
Symptoms: Chest pain, Decreased activity, Gait disturbance, Palpitations
Clinical narrative: UNABLE TO DO ANY ACTIVITY; BARELY EVEN WALK WITHOUT CHEST PAIN/PAIN; WAKE UP IN THE MIDDLE OF THE NIGHT WITH A RACING HEART; BARELY EVEN WALK; This spontaneous report received from a patient concerned a 35 year old male. The patient's height, and weight were not reported. The patient's pre-existing medical conditions included: The patient was healthy and exercised 3 to 4 times per week before vaccination. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin, and batch number were not reported) dose was not reported, administered on OCT-2021 for prophylactic vaccination. The batch number was not reported and has been requested. No concomitant medications were reported. On an unspecified date, the patient experienced unable to do any activity, barely even walk without chest pain/pain, wake up in the middle of the night with a racing heart, and barely even walk. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient was recovering from barely even walk without chest pain/pain, and barely even walk, and the outcome of unable to do any activity and wake up in the middle of the night with a racing heart was not reported. This report was non-serious.
Sex: U
Vaccine: COVID19
Symptoms: Influenza like illness, Skin infection
Clinical narrative: FLU LIKE SYMPTOMS; SKIN INFECTION IN LEFT LEG; This spontaneous report received from a patient via a company representative concerned a patient of unspecified age and sex. The patient's height, and weight were not reported. No past medical history or concurrent conditions were reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 205A21A, and expiry: UNKNOWN) dose was not reported, administered on 17-MAY-2021 for prophylactic vaccination. No concomitant medications were reported.  On an unspecified date, the patient experienced flu like symptoms, and skin infection in left leg. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the flu like symptoms and skin infection in left leg was not reported. This report was non-serious.
Sex: F
Vaccine: COVID19
Symptoms: Therapeutic response unexpected
Clinical narrative: BEFORE HER FIRST DOSE PATIENT HAD UTI AND AFTER THE SECOND DOSE SHE WAS IN BETTER HEALTH/IMPROVED HEALTH; This spontaneous report received from a female patient of unspecified age, race and ethnic origin. The patient's height, and weight were not reported. The patient's concurrent conditions included: UTI (Urinary Tract Infection)- time unspecified. The patient was previously treated with covid-19 vaccine ad26.cov2.s (dose number in series 1) (suspension for injection, route of admin not reported, batch number: unknown, expiry: unknown) 1 total, dose, start therapy date were not reported for prophylactic vaccination.  It was unknown whether patient had any adverse events following vaccination with first dose of covid-19 vaccine ad26.cov2.s (dose number in series 1). The patient additionally received covid-19 vaccine ad26.cov2.s (dose number in series 2) (suspension for injection, route of admin not reported, batch number: unknown, expiry: unknown) 1 total, dose, start therapy date were not reported for prophylactic vaccination. The batch number was not reported and has been requested. No concomitant medications were reported.  On an unspecified date, the patient reported that, she was very happy that she was able to get first and booster dose of Janssen COVID-19 vaccine. The patient reported that, before her first dose she had UTI which she believed was her fault, but after the second dose she was in better health (improved health) (coded to unexpected therapeutic benefit) (dose number in series 2). The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of before her first dose patient had UTI and after the second dose she was in better health/improved health was not reported. This report was non-serious.
Sex: F
Vaccine: COVID19
Symptoms: Injection site pain
Clinical narrative: SORE ARM, HURTING FOR A COUPLE OF DAYS AFTER RECEIVING INITIAL DOSE; This spontaneous report received from a patient concerned a female of unspecified age. The patient's height, and weight were not reported. No past medical history or concurrent conditions were reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 1855194, and expiry: UNKNOWN) dose was not reported, administered on 07-DEC-2021 for prophylactic vaccination.  No concomitant medications were reported.  On an unspecified date, the patient experienced sore arm, hurting for a couple of days after receiving initial dose. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from sore arm, hurting for a couple of days after receiving initial dose. This report was non-serious.
Sex: M
Vaccine: COVID19
Symptoms: Back pain, Body temperature, Burning sensation, Chest discomfort, Chills
Clinical narrative: HOT, BURNING UP; HIGH PULSE; BACK WAS HURTING; BREATHING WAS LITTLE DEEPER LAST NIGHT; APPEARED DEHYDRATED; SKIN SENSITIVITY; CHILLS; HEADACHE; FELT NAUSEOUS, BUT NEVER GOT SICK; RUNNING FEVER, FEVER WITH TEMPERATURE OF 101.9 TO 100.9 DEGREES CELCIUS, FEVER AROUND 100.6, TEMPERATURE WAS 103.2 AND HAD TEMPERATURE 100.9 WHEN WOKE UP; DIZZINESS WHEN STOOD TO WALK; CHEST FELT HOT; This spontaneous report received from a parent concerned an 18 year old male. The patient's height, and weight were not reported. The patient's concurrent conditions included: seasonal allergies. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin, and batch number were not reported) dose was not reported, administered on 21-APR-2022 for prophylactic vaccination. The batch number was not reported and has been requested. No concomitant medications were reported.  On 21-APR-2022, the patient experienced dizziness when stood to walk, chest felt hot, breathing was little deeper last night, appeared dehydrated, skin sensitivity, chills, headache, felt nauseous, but never got sick, and running fever, fever with temperature of 101.9 to 100.9 degrees celcius, fever around 100.6, temperature was 103.2 and had temperature 100.9 when woke up. Laboratory data included: Body temperature (NR: not provided) around 100.6, 101.9-100.9 C. On 22-APR-2022, the patient experienced hot, burning up, high pulse, and back was hurting. Laboratory data included: Body temperature (NR: not provided) 103.2, 100.9, and Pulse rate (NR: not provided) high. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient was recovering from running fever, fever with temperature of 101.9 to 100.9 degrees celcius, fever around 100.6, temperature was 103.2 and had temperature 100.9 when woke up, had not recovered from dizziness when stood to walk, and the outcome of headache, chills, chest felt hot, felt nauseous, but never got sick, hot, burning up, high pulse, back was hurting, breathing was little deeper last night, appeared dehydrated and skin sensitivity was not reported. This report was non-serious.
Sex: M
Vaccine: COVID19
Symptoms: Dehydration, Dizziness, Headache, Heart rate, Heart rate increased
Clinical narrative: HOT, BURNING UP; HIGH PULSE; BACK WAS HURTING; BREATHING WAS LITTLE DEEPER LAST NIGHT; APPEARED DEHYDRATED; SKIN SENSITIVITY; CHILLS; HEADACHE; FELT NAUSEOUS, BUT NEVER GOT SICK; RUNNING FEVER, FEVER WITH TEMPERATURE OF 101.9 TO 100.9 DEGREES CELCIUS, FEVER AROUND 100.6, TEMPERATURE WAS 103.2 AND HAD TEMPERATURE 100.9 WHEN WOKE UP; DIZZINESS WHEN STOOD TO WALK; CHEST FELT HOT; This spontaneous report received from a parent concerned an 18 year old male. The patient's height, and weight were not reported. The patient's concurrent conditions included: seasonal allergies. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin, and batch number were not reported) dose was not reported, administered on 21-APR-2022 for prophylactic vaccination. The batch number was not reported and has been requested. No concomitant medications were reported.  On 21-APR-2022, the patient experienced dizziness when stood to walk, chest felt hot, breathing was little deeper last night, appeared dehydrated, skin sensitivity, chills, headache, felt nauseous, but never got sick, and running fever, fever with temperature of 101.9 to 100.9 degrees celcius, fever around 100.6, temperature was 103.2 and had temperature 100.9 when woke up. Laboratory data included: Body temperature (NR: not provided) around 100.6, 101.9-100.9 C. On 22-APR-2022, the patient experienced hot, burning up, high pulse, and back was hurting. Laboratory data included: Body temperature (NR: not provided) 103.2, 100.9, and Pulse rate (NR: not provided) high. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient was recovering from running fever, fever with temperature of 101.9 to 100.9 degrees celcius, fever around 100.6, temperature was 103.2 and had temperature 100.9 when woke up, had not recovered from dizziness when stood to walk, and the outcome of headache, chills, chest felt hot, felt nauseous, but never got sick, hot, burning up, high pulse, back was hurting, breathing was little deeper last night, appeared dehydrated and skin sensitivity was not reported. This report was non-serious.
Sex: M
Vaccine: COVID19
Symptoms: Hyperventilation, Nausea, Pyrexia, Sensitive skin
Clinical narrative: HOT, BURNING UP; HIGH PULSE; BACK WAS HURTING; BREATHING WAS LITTLE DEEPER LAST NIGHT; APPEARED DEHYDRATED; SKIN SENSITIVITY; CHILLS; HEADACHE; FELT NAUSEOUS, BUT NEVER GOT SICK; RUNNING FEVER, FEVER WITH TEMPERATURE OF 101.9 TO 100.9 DEGREES CELCIUS, FEVER AROUND 100.6, TEMPERATURE WAS 103.2 AND HAD TEMPERATURE 100.9 WHEN WOKE UP; DIZZINESS WHEN STOOD TO WALK; CHEST FELT HOT; This spontaneous report received from a parent concerned an 18 year old male. The patient's height, and weight were not reported. The patient's concurrent conditions included: seasonal allergies. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin, and batch number were not reported) dose was not reported, administered on 21-APR-2022 for prophylactic vaccination. The batch number was not reported and has been requested. No concomitant medications were reported.  On 21-APR-2022, the patient experienced dizziness when stood to walk, chest felt hot, breathing was little deeper last night, appeared dehydrated, skin sensitivity, chills, headache, felt nauseous, but never got sick, and running fever, fever with temperature of 101.9 to 100.9 degrees celcius, fever around 100.6, temperature was 103.2 and had temperature 100.9 when woke up. Laboratory data included: Body temperature (NR: not provided) around 100.6, 101.9-100.9 C. On 22-APR-2022, the patient experienced hot, burning up, high pulse, and back was hurting. Laboratory data included: Body temperature (NR: not provided) 103.2, 100.9, and Pulse rate (NR: not provided) high. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient was recovering from running fever, fever with temperature of 101.9 to 100.9 degrees celcius, fever around 100.6, temperature was 103.2 and had temperature 100.9 when woke up, had not recovered from dizziness when stood to walk, and the outcome of headache, chills, chest felt hot, felt nauseous, but never got sick, hot, burning up, high pulse, back was hurting, breathing was little deeper last night, appeared dehydrated and skin sensitivity was not reported. This report was non-serious.
Age: 36.0
Sex: F
Vaccine: COVID19
Symptoms: Expired product administered, Product storage error, SARS-CoV-2 test
Clinical narrative: Patient received a vaccine past the 30 day storage on the refrigerator; Dose administered after 30-day Use By Date; This spontaneous case was reported by a nurse and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Dose administered after 30-day Use By Date) and PRODUCT STORAGE ERROR (Patient received a vaccine past the 30 day storage on the refrigerator) in a 36-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 027L21A) for COVID-19 vaccination.     Concomitant products included CARVEDILOL for an unknown indication.    On 13-Apr-2022 at 1:46 PM, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 13-Apr-2022 at 1:46 PM, the patient experienced EXPIRED PRODUCT ADMINISTERED (Dose administered after 30-day Use By Date). On an unknown date, the patient experienced PRODUCT STORAGE ERROR (Patient received a vaccine past the 30 day storage on the refrigerator). At the time of the report, EXPIRED PRODUCT ADMINISTERED (Dose administered after 30-day Use By Date) and PRODUCT STORAGE ERROR (Patient received a vaccine past the 30 day storage on the refrigerator) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, SARS-CoV-2 test: no No.     For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   Patient did not have any known allergies. Patient was not COVID-19 positive withing last month. On 25-Feb-2022, the vial was initially stored in the refrigerator. The vial did not undergo any temperature excursions. Patient did not experience any side effects yet. No Treatment information was reported.
Age: 69.0
Sex: F
Vaccine: COVID19
Symptoms: Expired product administered, Product storage error
Clinical narrative: Vial was stored in the refrigerator since 7-Mar-2022 in temperatures between 2 to 8 celcius degrees then administered on Apr-2022; patients were administered The Moderna Covid 19 vaccine after its 30-day Use By Date.; This spontaneous case was reported by a nurse and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (patients were administered The Moderna Covid 19 vaccine after its 30-day Use By Date.) and PRODUCT STORAGE ERROR (Vial was stored in the refrigerator since 7-Mar-2022 in temperatures between 2 to 8 celcius degrees then administered on Apr-2022) in a 69-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 046L21A, 048C21A, 004M20A and 026L20A) for COVID-19 vaccination.     It was unknown whether the patient was ever been diagnosed or tested positive for COVID-19. Acute illnesses at the time of vaccination and up to one month before was unknown.    On 14-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) .5 milliliter. On 14-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to .5 milliliter. On 09-Nov-2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to .25 milliliter. On 08-Apr-2022, received fourth dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to .25 milliliter. On 08-Apr-2022, the patient experienced EXPIRED PRODUCT ADMINISTERED (patients were administered The Moderna Covid 19 vaccine after its 30-day Use By Date.). On an unknown date, the patient experienced PRODUCT STORAGE ERROR (Vial was stored in the refrigerator since 7-Mar-2022 in temperatures between 2 to 8 celcius degrees then administered on Apr-2022). At the time of the report, EXPIRED PRODUCT ADMINISTERED (patients were administered The Moderna Covid 19 vaccine after its 30-day Use By Date.) and PRODUCT STORAGE ERROR (Vial was stored in the refrigerator since 7-Mar-2022 in temperatures between 2 to 8 celcius degrees then administered on Apr-2022) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant medications were reported. The reporter states like 7 patients were vaccinated on 08-Apr-2022 and 2 patients on 11-Apr-2022. It was reported that vaccine was given beyond use date. Vaccine was administered to patient 2 days past the 30-day time in refrigerator. No treatment medications were reported.   This case was linked to MOD-2022-539590, MOD-2022-546716 (Patient Link).   Most recent FOLLOW-UP information incorporated above includes: On 21-Apr-2022: Significant follow-up received: Case was upgraded to valid. Additional reporter, patient demographic details, dosing details of other doses were added. Date of vaccination for 4th dose, event onset date, reporter causality for the event (expiry vaccine) and inarrative were updated.
Age: 36.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Inappropriate schedule of product administration
Clinical narrative: first dose is Moderna Covid-19 vaccine and Primary dose as a Pfizer vaccine; This spontaneous case was reported by a nurse and describes the occurrence of INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (first dose is Moderna Covid-19 vaccine and Primary dose as a Pfizer vaccine) in a 36-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.    Co-suspect product included non-company product TOZINAMERAN (PFIZER BIONTECH COVID-19 VACCINE) for an unknown indication.    No Medical History information was reported.   On 30-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient received dose of TOZINAMERAN (PFIZER BIONTECH COVID-19 VACCINE) (unknown route) 1 dosage form. On an unknown date, the patient experienced INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (first dose is Moderna Covid-19 vaccine and Primary dose as a Pfizer vaccine). At the time of the report, INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (first dose is Moderna Covid-19 vaccine and Primary dose as a Pfizer vaccine) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant medication were provided. It was reported that the patient received her Primary dose as a Pfizer vaccine in los Angeles. No other information is known about these doses or adverse reactions. No treatment details were provided   This case was linked to MOD-2022-543462 (Patient Link).
Sex: U
Vaccine: COVID19
Symptoms: Pyrexia
Clinical narrative: fever after getting the 1st booster dose; This spontaneous case was reported by a pharmacist and describes the occurrence of PYREXIA (fever after getting the 1st booster dose) 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 third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient experienced PYREXIA (fever after getting the 1st booster dose). At the time of the report, PYREXIA (fever after getting the 1st booster dose) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   Concomitant medication information was not provided by the reporter.  Patient had fever for 7-10 days after getting the 1st booster dose.  Treatment information was not provided by the reporter.   This case was linked to MOD-2022-545536 (Patient Link).
Age: 79.0
Sex: F
Vaccine: COVID19
Symptoms: Inappropriate schedule of product administration
Clinical narrative: Three patient that received the second  booster to early; This spontaneous case was reported by a nurse and describes the occurrence of INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Three patient that received the second  booster to early) in an 81-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 027L21A, 069H21A, 006B21A and 024M20A) for COVID-19 vaccination.     No Medical History information was reported.   On 02-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 30-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 26-Dec-2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 14-Apr-2022, received fourth dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 14-Apr-2022, the patient experienced INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Three patient that received the second  booster to early). At the time of the report, INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Three patient that received the second  booster to early) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant medication reported. No treatment information was reported.  It was unknown if other vaccines had been given to patient within 1 month prior to Moderna COVID-19 vaccine. It was unknown if patient had seek medical care (office visit, Urgent care, ER, hospitalized).   Most recent FOLLOW-UP information incorporated above includes: On 20-Apr-2022: Follow up received contain Non-significant information. Reporters contact details updated.
Age: 63.0
Sex: M
Vaccine: COVID19
Symptoms: Poor quality product administered, Product temperature excursion issue
Clinical narrative: Paitents have been administered from Vaccine that experienced a temperature excursion; Paitents have been administered from Vaccine that experienced a temperature excursion; This spontaneous case was reported by an other health care professional and describes the occurrence of POOR QUALITY PRODUCT ADMINISTERED (Paitents have been administered from Vaccine that experienced a temperature excursion) and PRODUCT TEMPERATURE EXCURSION ISSUE (Paitents have been administered from Vaccine that experienced a temperature excursion) in a 63-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 027L21A) for COVID-19 vaccination.     No Medical History information was reported.    On 18-Mar-2022, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 10-Mar-2022, the patient experienced PRODUCT TEMPERATURE EXCURSION ISSUE (Paitents have been administered from Vaccine that experienced a temperature excursion). On 18-Mar-2022, the patient experienced POOR QUALITY PRODUCT ADMINISTERED (Paitents have been administered from Vaccine that experienced a temperature excursion). At the time of the report, POOR QUALITY PRODUCT ADMINISTERED (Paitents have been administered from Vaccine that experienced a temperature excursion) and PRODUCT TEMPERATURE EXCURSION ISSUE (Paitents have been administered from Vaccine that experienced a temperature excursion) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant medications were reported.  Storage condition at the time of the excursion was reported as refrigerator. Maximum temperature reached was reported as 64°F. Excursion duration was reported as approximately 7 hours. Date vial moved from freezer to refrigerator was reported as unknown. They were returned to the refrigerator. No changes on visual inspection noting vaccine state. At the time they were unpunctured. The Tran date was reported as 18-Mar-2022.  The patient not had any adverse events post injection.  No treatment information was reported.
Age: 69.0
Sex: F
Vaccine: COVID19
Symptoms: Diarrhoea, Headache, Insomnia, Mobility decreased, Tinnitus
Clinical narrative: in bed for 3 days; throwing up; diarrhea; horrible headache; trouble sleeping with the sound; tinnitus,some days worse than others,hissing sound; This spontaneous case was reported by a consumer and describes the occurrence of MOBILITY DECREASED (in bed for 3 days), VOMITING (throwing up), DIARRHOEA (diarrhea), HEADACHE (horrible headache) and TINNITUS (tinnitus,some days worse than others,hissing sound) in a 69-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 029K20A and 011J20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     Concurrent medical conditions included Asthma and Blood pressure high. Concomitant products included SALBUTAMOL SULFATE (INHALERIN) for Asthma, LOVASTATIN for Cholesterol.   On 09-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 06-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. In January 2022, the patient experienced TINNITUS (tinnitus,some days worse than others,hissing sound). On an unknown date, the patient experienced MOBILITY DECREASED (in bed for 3 days), VOMITING (throwing up), DIARRHOEA (diarrhea), HEADACHE (horrible headache) and INSOMNIA (trouble sleeping with the sound). The patient was treated with PARACETAMOL (TYLENOL [PARACETAMOL]) at an unspecified dose and frequency and LORATADINE (CLARITINE) for Tinnitus, at an unspecified dose and frequency. At the time of the report, MOBILITY DECREASED (in bed for 3 days), VOMITING (throwing up), DIARRHOEA (diarrhea), HEADACHE (horrible headache), TINNITUS (tinnitus,some days worse than others,hissing sound) and INSOMNIA (trouble sleeping with the sound) outcome was unknown.            Patient taking blood pressure pill as concomitant. Patient was on nose spray for tinnitus.   Most recent FOLLOW-UP information incorporated above includes: On 21-Apr-2022: Non Significant Follow-up received
Age: 69.0
Sex: F
Vaccine: COVID19
Symptoms: Vomiting
Clinical narrative: in bed for 3 days; throwing up; diarrhea; horrible headache; trouble sleeping with the sound; tinnitus,some days worse than others,hissing sound; This spontaneous case was reported by a consumer and describes the occurrence of MOBILITY DECREASED (in bed for 3 days), VOMITING (throwing up), DIARRHOEA (diarrhea), HEADACHE (horrible headache) and TINNITUS (tinnitus,some days worse than others,hissing sound) in a 69-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 029K20A and 011J20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     Concurrent medical conditions included Asthma and Blood pressure high. Concomitant products included SALBUTAMOL SULFATE (INHALERIN) for Asthma, LOVASTATIN for Cholesterol.   On 09-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 06-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. In January 2022, the patient experienced TINNITUS (tinnitus,some days worse than others,hissing sound). On an unknown date, the patient experienced MOBILITY DECREASED (in bed for 3 days), VOMITING (throwing up), DIARRHOEA (diarrhea), HEADACHE (horrible headache) and INSOMNIA (trouble sleeping with the sound). The patient was treated with PARACETAMOL (TYLENOL [PARACETAMOL]) at an unspecified dose and frequency and LORATADINE (CLARITINE) for Tinnitus, at an unspecified dose and frequency. At the time of the report, MOBILITY DECREASED (in bed for 3 days), VOMITING (throwing up), DIARRHOEA (diarrhea), HEADACHE (horrible headache), TINNITUS (tinnitus,some days worse than others,hissing sound) and INSOMNIA (trouble sleeping with the sound) outcome was unknown.            Patient taking blood pressure pill as concomitant. Patient was on nose spray for tinnitus.   Most recent FOLLOW-UP information incorporated above includes: On 21-Apr-2022: Non Significant Follow-up received
Sex: U
Vaccine: COVID19
Symptoms: Expired product administered, Product storage error
Clinical narrative: A dose of Moderna Covid-19 vaccine was given from a vial that was open to room temperature for more than 12hrs; Vial was first punctured on 19 Apr 2022 at 3p, post puncture stored in refrigerator and administered on 20  Apr 2022.; This spontaneous case was reported by a pharmacist and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (A dose of Moderna Covid-19 vaccine was given from a vial that was open to room temperature for more than 12hrs) and PRODUCT STORAGE ERROR (Vial was first punctured on 19 Apr 2022 at 3p, post puncture stored in refrigerator and administered on 20  Apr 2022.) in a  patient of an unknown age and gender who received mRNA-1273 (Spikevax) (batch no. 005M21A) for COVID-19 vaccination.     No Medical History information was reported.    On 20-Apr-2022, the patient received dose of mRNA-1273 (Spikevax) (unknown route) 1 dosage form. In April 2022, the patient experienced PRODUCT STORAGE ERROR (Vial was first punctured on 19 Apr 2022 at 3p, post puncture stored in refrigerator and administered on 20  Apr 2022.). On 20-Apr-2022, the patient experienced EXPIRED PRODUCT ADMINISTERED (A dose of Moderna Covid-19 vaccine was given from a vial that was open to room temperature for more than 12hrs). At the time of the report, EXPIRED PRODUCT ADMINISTERED (A dose of Moderna Covid-19 vaccine was given from a vial that was open to room temperature for more than 12hrs) and PRODUCT STORAGE ERROR (Vial was first punctured on 19 Apr 2022 at 3p, post puncture stored in refrigerator and administered on 20  Apr 2022.) outcome was unknown.        For mRNA-1273 (Spikevax) (Unknown), the reporter did not provide any causality assessments.   No information on concomitant medication was reported. A dose of Moderna Covid-19 vaccine was given from a vial that was open to room temperature for more than 12hrs.The vial was initially stored in the refrigerator on 18 Apr 2022. The vial was first punctured on 19 Apr 2022 at 3p. The vial was stored in refrigerator post puncture. The vial did not undergo any temperature excursions. The vial was exposed to room temperature range for greater than 12 hours, less than 24hours.  No information on treatment medication was reported.   Most recent FOLLOW-UP information incorporated above includes: On 21-Apr-2022: Follow-up information received contains no new information.
Age: 60.0
Sex: M
Vaccine: COVID19
Symptoms: Expired product administered, Product storage error
Clinical narrative: The vial was initially stored in the refrigerator on 25-Feb-2022 and administered on 06-Apr-2022; received vaccine past the 30 day storage on the refrigerator; This spontaneous case was reported by a nurse and describes the occurrence of PRODUCT STORAGE ERROR (The vial was initially stored in the refrigerator on 25-Feb-2022 and administered on 06-Apr-2022) and EXPIRED PRODUCT ADMINISTERED (received vaccine past the 30 day storage on the refrigerator) in a 60-year-old male patient who received mRNA-1273 (Spikevax) (batch no. 027L21A) for COVID-19 vaccination.     Concurrent medical conditions included Allergic reaction to analgesics (Percocet), Hyperthyroidism and Hepatitis C. Concomitant products included ALBUTEROL SULFATE, FLUTICASONE FUROATE (ARNUITY ELLIPTA), ATORVASTATIN, HYDRALAZINE, AMLODIPINE, HCTZ, FLUTICASONE and PANTOPRAZOLE for an unknown indication.    On 06-Apr-2022 at 3:38 PM, the patient received second dose of mRNA-1273 (Spikevax) (unknown route) 1 dosage form. On 06-Apr-2022 at 3:38 PM, the patient experienced EXPIRED PRODUCT ADMINISTERED (received vaccine past the 30 day storage on the refrigerator). On an unknown date, the patient experienced PRODUCT STORAGE ERROR (The vial was initially stored in the refrigerator on 25-Feb-2022 and administered on 06-Apr-2022). At the time of the report, PRODUCT STORAGE ERROR (The vial was initially stored in the refrigerator on 25-Feb-2022 and administered on 06-Apr-2022) and EXPIRED PRODUCT ADMINISTERED (received vaccine past the 30 day storage on the refrigerator) outcome was unknown.        For mRNA-1273 (Spikevax) (Unknown), the reporter did not provide any causality assessments.   On 25-Feb-2022 vial was initially stored in the refrigerator. It was reported the patients were vaccinated with the Moderna Vaccine after the expiration of 25-Mar-2022   Vial did not undergo any temperature excursions  HCP confirmed that the patients were not experiencing any side effects yet.  Patient had not tested COVID-19 within last month. No treatment medication information was given.
Sex: U
Vaccine: COVID19
Symptoms: Chapped lips, Hypersensitivity, Rash
Clinical narrative: my lips to loose all the skin still suffering from this with my lips not being ab; instantly had an allergic reaction; rashes all over my body; This spontaneous case was reported by a pharmacist and describes the occurrence of CHAPPED LIPS (my lips to loose all the skin still suffering from this with my lips not being ab), HYPERSENSITIVITY (instantly had an allergic reaction) and RASH (rashes all over my body) 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.    In September 2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. In September 2021, the patient experienced CHAPPED LIPS (my lips to loose all the skin still suffering from this with my lips not being ab), HYPERSENSITIVITY (instantly had an allergic reaction) and RASH (rashes all over my body). At the time of the report, CHAPPED LIPS (my lips to loose all the skin still suffering from this with my lips not being ab), HYPERSENSITIVITY (instantly had an allergic reaction) and RASH (rashes all over my body) had not resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant medication information provided.  Patient got the second dose of the Moderna vaccine in September, and instantly had an allergic reaction which resulted in rashes all over body and patient's lips to loose all then skin. Nowin April patient was still suffering from this with lips not being ab.  No treatment medication information provided.