chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 72.0
Sex: M
Vaccine: COVID19
Symptoms: Expired product administered, Inappropriate schedule of product administration
Clinical narrative: Administer a vaccine  that expired on the 29-Apr-2022 to less than 5 patients; Dose 1 on 16-Nov-2021 and dose 2 on 06-May-2022; This spontaneous case was reported by an other health care professional and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Administer a vaccine  that expired on the 29-Apr-2022 to less than 5 patients) and INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Dose 1 on 16-Nov-2021 and dose 2 on 06-May-2022) in a 73-year-old male patient who received mRNA-1273 (Spikevax) (batch nos. 042J21A and 012F21A) for COVID-19 vaccination.     No Medical History information was reported.   On 16-Nov-2021 at 1:18 PM, the patient received first dose of mRNA-1273 (Spikevax) (Intramuscular) .5 milliliter. On 06-May-2022 at 10:39 AM, received second dose of mRNA-1273 (Spikevax) (Intramuscular) dosage was changed to .5 milliliter. On 06-May-2022 at 10:39 AM, the patient experienced EXPIRED PRODUCT ADMINISTERED (Administer a vaccine  that expired on the 29-Apr-2022 to less than 5 patients) and INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Dose 1 on 16-Nov-2021 and dose 2 on 06-May-2022). At the time of the report, EXPIRED PRODUCT ADMINISTERED (Administer a vaccine  that expired on the 29-Apr-2022 to less than 5 patients) and INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Dose 1 on 16-Nov-2021 and dose 2 on 06-May-2022) outcome was unknown.        For mRNA-1273 (Spikevax) (Intramuscular), the reporter did not provide any causality assessments.   No concomitant medications were reported. It was reported that on unknown date the vail was initially stored in refrigerator. The vial did not undergo any temperature excursion. No treatment medications were provided.   This case was linked to MOD-2022-573908 (Patient Link).
Age: 58.0
Sex: M
Vaccine: COVID19
Symptoms: Expired product administered, Inappropriate schedule of product administration
Clinical narrative: Vaccine was adminstered to the patient which was expired on 29-Apr-2022; Dose 1 on 27-JUL-2021 and dose 2 on 20-OCT-2021, time period between 1st and 2nd dose was more than 25 to 35 days.; This spontaneous case was reported by an other health care professional and describes the occurrence of INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Dose 1 on 27-JUL-2021 and dose 2 on 20-OCT-2021, time period between 1st and 2nd dose was more than 25 to 35 days.) and EXPIRED PRODUCT ADMINISTERED (Vaccine was adminstered to the patient which was expired on 29-Apr-2022) in a 58-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 042j21a, 011F21A and 023d1A) for COVID-19 vaccination.     It was unknown if the patient was diagnosed or tested positive for COVID-19. It was unknown if patient had acute illness at the time of vaccination and or up to one month before. It was unknown if patient was having chronic or long standing health condition.    On 27-Jul-2021 at 3:12 PM, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) .5 milliliter. On 20-Oct-2021 at 12:34 PM, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to .5 milliliter. On 06-May-2022 at 11:17 AM, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to .25 milliliter. On 20-Oct-2021 at 12:34 PM, the patient experienced INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Dose 1 on 27-JUL-2021 and dose 2 on 20-OCT-2021, time period between 1st and 2nd dose was more than 25 to 35 days.). On 06-May-2022 at 11:17 AM,  after starting mRNA-1273 (Moderna COVID-19 Vaccine), the patient experienced EXPIRED PRODUCT ADMINISTERED (Vaccine was adminstered to the patient which was expired on 29-Apr-2022). At the time of the report, INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Dose 1 on 27-JUL-2021 and dose 2 on 20-OCT-2021, time period between 1st and 2nd dose was more than 25 to 35 days.) and EXPIRED PRODUCT ADMINISTERED (Vaccine was adminstered to the patient which was expired on 29-Apr-2022) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   No concomitant medications were reported.  It was unknown  when the vial was initially stored in the refrigerator. Vial did not undergo any temperature excursions.  No treatment information were reported.   This case was linked to MOD-2022-573908 (Patient Link).
Age: 69.0
Sex: F
Vaccine: COVID19
Symptoms: Body temperature, Fatigue, Feeling abnormal, Lymphadenopathy, Pyrexia
Clinical narrative: Low fever under 100 Fahrenheit degrees; Swollen lymph node on left arm pit/felt the lymph node was starting to swell; Feeling tired; Feeling horrible; This spontaneous case was reported by a patient and describes the occurrence of PYREXIA (Low fever under 100 Fahrenheit degrees), LYMPHADENOPATHY (Swollen lymph node on left arm pit/felt the lymph node was starting to swell), FATIGUE (Feeling tired) and FEELING ABNORMAL (Feeling horrible) in a 69-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 054A22A) for COVID-19 vaccination.     Patient had no allergies. Patient never tested positive for Covid-19.  Previously administered products included for Product used for unknown indication: Pfizer (1st dose, Lot: EN6201) on 16-Feb-2021, Pfizer (2nd Dose, Lot: EN6208) on 09-Mar-2021, flu vaccine in October 2021, flu vaccine in October 2021, flu vaccine in October 2021, flu vaccine in October 2021, Pfizer (1st Booster dose and Lot: FF2593) on 01-Dec-2021. Past adverse reactions to the above products included Feeling abnormal with flu vaccine; Low grade fever with flu vaccine; No adverse event with Pfizer, Pfizer and Pfizer; Swollen lymph nodes with flu vaccine; and Tiredness with flu vaccine. Concomitant products included ZINC, VITAMINS NOS and BUPROPION HYDROCHLORIDE (WELLBUTRIN) for an unknown indication.    On 31-May-2022, the patient received fourth dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 01-Jun-2022, the patient experienced PYREXIA (Low fever under 100 Fahrenheit degrees), LYMPHADENOPATHY (Swollen lymph node on left arm pit/felt the lymph node was starting to swell), FATIGUE (Feeling tired) and FEELING ABNORMAL (Feeling horrible). The patient was treated with PARACETAMOL (TYLENOL) for Adverse event, at an unspecified dose and frequency and ASPIRIN [ACETYLSALICYLIC ACID] for Adverse event, at an unspecified dose and frequency. At the time of the report, PYREXIA (Low fever under 100 Fahrenheit degrees), LYMPHADENOPATHY (Swollen lymph node on left arm pit/felt the lymph node was starting to swell), FATIGUE (Feeling tired) and FEELING ABNORMAL (Feeling horrible) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 01-Jun-2022, Body temperature: under 100 (Low) low fever under 100 degrees.         Other concomitant medication included Acetamidine for an unknown indication. Patient never tested positive for Covid 19 and patient believes patient might have had these symptoms because it is the first time that patient receives a Moderna vaccine.
Age: 66.0
Sex: M
Vaccine: COVID19
Symptoms: Fatigue, Insomnia, Pain, Pain in extremity
Clinical narrative: This spontaneous case was reported by a patient and describes the occurrence of PAIN (it gave them pain, and they don't recall been sore until later on the day of the vaccination/how long does the soreness last), INSOMNIA (did not sleep at all/went to bed at 9 o'clock/slept for two hours/couldn't sleep at all, because their arm hurt/they haven't gone to sleep at 9 o'clock since been a boy and woke up at 12 o'clock), PAIN IN EXTREMITY (arm hurt) and FATIGUE (has been very tired since/felt tired/very tired/felt fatigue and felt like doing nothing) in a 66-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 002M21A) for COVID-19 vaccination.     The patient never had COVID positive test or COVID diagnosis. The patient did not have any acute and chronic illnesses at the time of vaccination.  Previously administered products included for Product used for unknown indication: PFIZER BIONTECH COVID-19 VACCINE (first booster) and COVID-19 Vaccine Johnson and Johnson (primary series). Past adverse reactions to the above products included No adverse event with COVID-19 Vaccine Johnson and Johnson and PFIZER BIONTECH COVID-19 VACCINE. Concurrent medical conditions included Penicillin allergy and Blood pressure high.    On 31-May-2022, the patient received fourth dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 31-May-2022, the patient experienced PAIN (it gave them pain, and they don't recall been sore until later on the day of the vaccination/how long does the soreness last). On 01-Jun-2022, the patient experienced INSOMNIA (did not sleep at all/went to bed at 9 o'clock/slept for two hours/couldn't sleep at all, because their arm hurt/they haven't gone to sleep at 9 o'clock since been a boy and woke up at 12 o'clock), PAIN IN EXTREMITY (arm hurt) and FATIGUE (has been very tired since/felt tired/very tired/felt fatigue and felt like doing nothing). At the time of the report, PAIN (it gave them pain, and they don't recall been sore until later on the day of the vaccination/how long does the soreness last) and PAIN IN EXTREMITY (arm hurt) had not resolved and INSOMNIA (did not sleep at all/went to bed at 9 o'clock/slept for two hours/couldn't sleep at all, because their arm hurt/they haven't gone to sleep at 9 o'clock since been a boy and woke up at 12 o'clock) and FATIGUE (has been very tired since/felt tired/very tired/felt fatigue and felt like doing nothing) was resolving.            No other vaccines were given within 1 month prior to Moderna COVID-19 vaccine.   Concomitant medications of the patient included unknown high blood pressure medicine and an unknown sleeping pill nightly.  The adverse events did not cause the patient to seek medical care (office visit, Urgent care, ER, hospitalized). The symptoms of the patient were bit better. The patient wanted to how long the soreness last because it had been three days.  No treatment information was provided by the reporter.
Age: 71.0
Sex: F
Vaccine: COVID19
Symptoms: Inappropriate schedule of product administration
Clinical narrative: Dose 1 and 2 received on 19-JAN-2021 and 12-FEB-2021, 24 days apart; This spontaneous case was reported by a physician and describes the occurrence of INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Dose 1 and 2 received on 19-JAN-2021 and 12-FEB-2021, 24 days apart) in a 71-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     Concurrent medical conditions included Hypertension, GERD, Osteoporosis and Drug allergy (None. Unknown historical drug). Concomitant products included ROMOSOZUMAB (EVENITY [ROMOSOZUMAB]), FAMOTIDINE, LISINOPRIL, SERTRALINE, CALCIUM, COLECALCIFEROL (CALCIUM + D3 [CALCIUM;COLECALCIFEROL]) and MULTIVITAMIN [VITAMINS NOS] for an unknown indication.   On 19-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 12-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 12-Feb-2021,  after starting mRNA-1273 (Moderna COVID-19 Vaccine), the patient experienced INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Dose 1 and 2 received on 19-JAN-2021 and 12-FEB-2021, 24 days apart). At the time of the report, INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Dose 1 and 2 received on 19-JAN-2021 and 12-FEB-2021, 24 days apart) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No treatment medications were provided.   This case was linked to MOD-2022-581874 (Patient Link).
Age: 75.0
Sex: F
Vaccine: COVID19
Symptoms: Accidental underdose
Clinical narrative: Patient somehow instead of receiving the 1st dose, the patient received the booster dose; This spontaneous case was reported by a pharmacist and describes the occurrence of ACCIDENTAL UNDERDOSE (Patient somehow instead of receiving the 1st dose, the patient received the booster dose) in a 75-year-old female patient who received mRNA-1273 (Spikevax) for COVID-19 vaccination.     No Medical History information was reported.    On an unknown date, the patient received first dose of mRNA-1273 (Spikevax) (Intramuscular) .25 milliliter. On an unknown date, the patient experienced ACCIDENTAL UNDERDOSE (Patient somehow instead of receiving the 1st dose, the patient received the booster dose). At the time of the report, ACCIDENTAL UNDERDOSE (Patient somehow instead of receiving the 1st dose, the patient received the booster dose) outcome was unknown.        For mRNA-1273 (Spikevax) (Intramuscular), the reporter did not provide any causality assessments.   No concomitant drug was reported.  3 weeks later, the patient came back for the second dose. As result of misadministration no side effects reported.  No treatment drug was reported.
Sex: U
Vaccine: COVID19
Symptoms: Expired product administered, Product storage error
Clinical narrative: Vial was initially stored in the refrigerator on 16FEB2022, Refrigeration Expiry date was 17MAR2022/ Date of administration of vaccine was on 22MAR2022; Patient received expired Moderna COVID-19 vaccine beyond the 30 day refrigerator shelf life; This spontaneous case was reported by a nurse and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Patient received expired Moderna COVID-19 vaccine beyond the 30 day refrigerator shelf life) and PRODUCT STORAGE ERROR (Vial was initially stored in the refrigerator on 16FEB2022, Refrigeration Expiry date was 17MAR2022/ Date of administration of vaccine was on 22MAR2022) in a  patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 027L21A) for COVID-19 vaccination.     No Medical History information was reported.  On 22-Mar-2022, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 22-Mar-2022, the patient experienced EXPIRED PRODUCT ADMINISTERED (Patient received expired Moderna COVID-19 vaccine beyond the 30 day refrigerator shelf life). On an unknown date, the patient experienced PRODUCT STORAGE ERROR (Vial was initially stored in the refrigerator on 16FEB2022, Refrigeration Expiry date was 17MAR2022/ Date of administration of vaccine was on 22MAR2022). At the time of the report, EXPIRED PRODUCT ADMINISTERED (Patient received expired Moderna COVID-19 vaccine beyond the 30 day refrigerator shelf life) and PRODUCT STORAGE ERROR (Vial was initially stored in the refrigerator on 16FEB2022, Refrigeration Expiry date was 17MAR2022/ Date of administration of vaccine was on 22MAR2022) outcome was unknown.      For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant medications were provided.  It was reported that, patient received first booster dose. Number of doses/vials was 1 dose/ 1 vial. Date the vial was initially stored in the refrigerator was 16FEB2022 (Refrigeration Expiry date 17MAR2022). The vial did not undergone any temperature excursions.  No treatment medications were reported.
Age: 29.0
Sex: F
Vaccine: COVID19, UNK
Symptoms: Inappropriate schedule of product administration, Migraine, Urticaria
Clinical narrative: Migraine; Hives; patient received first dose on 05-Jun-2021 and second dose on 02-Aug-2021; This spontaneous case was reported by a consumer and describes the occurrence of MIGRAINE (Migraine), URTICARIA (Hives) and INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (patient received first dose on 05-Jun-2021 and second dose on 02-Aug-2021) in a 29-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.    Co-suspect product included non-company product ADALIMUMAB (HUMIRA) for Psoriatic arthritis.    Concurrent medical conditions included Psoriatic arthritis.   On 05-Jun-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 02-Aug-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 10-Oct-2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On an unknown date, the patient started ADALIMUMAB (HUMIRA) (Subcutaneous) 40 milligram. On 02-Aug-2021, the patient experienced INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (patient received first dose on 05-Jun-2021 and second dose on 02-Aug-2021). On an unknown date, the patient experienced MIGRAINE (Migraine) and URTICARIA (Hives). At the time of the report, MIGRAINE (Migraine) and INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (patient received first dose on 05-Jun-2021 and second dose on 02-Aug-2021) outcome was unknown and URTICARIA (Hives) was resolving.            No concomitant medication were reported.It was unknown if patient was enrolled in a COVID-19 Vaccine trial. No treatment information were provided.
Age: 49.0
Sex: F
Vaccine: COVID19
Symptoms: Accidental overdose
Clinical narrative: A Medical Assistant inadvertently gave a 0.5ml volume of the Moderna Covid-19 vaccine to a patient for their booster dose.the dose came from Moderna COVID-19 Vaccine with a red cap and a label with a; This spontaneous case was reported by an other health care professional and describes the occurrence of ACCIDENTAL OVERDOSE (A Medical Assistant inadvertently gave a 0.5ml volume of the Moderna Covid-19 vaccine to a patient for their booster dose.the dose came from Moderna COVID-19 Vaccine with a red cap and a label with a) in a 49-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 038A202A and 058F21A) for COVID-19 vaccination.     No Medical History information was reported.   On 02-Jun-2022, the patient received fourth dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to .5 milliliter. 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 and first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 02-Jun-2022, the patient experienced ACCIDENTAL OVERDOSE (A Medical Assistant inadvertently gave a 0.5ml volume of the Moderna Covid-19 vaccine to a patient for their booster dose.the dose came from Moderna COVID-19 Vaccine with a red cap and a label with a). At the time of the report, ACCIDENTAL OVERDOSE (A Medical Assistant inadvertently gave a 0.5ml volume of the Moderna Covid-19 vaccine to a patient for their booster dose.the dose came from Moderna COVID-19 Vaccine with a red cap and a label with a) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant medication was reported. it was reported that the dose came from Moderna COVID-19 Vaccine with a red cap and a label with a light blue border. The patient received her first two Moderna Covid-19 vaccines from the State. The patient did not report any adverse reactions or side effects to her first booster dose. Lot number of the vaccine dose incorrectly given is 038A202A expiration date is 30Aug2022. No treatment medication was reported.
Age: 52.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Ear disorder, Limb injury, Neck pain
Clinical narrative: Left Shoulder injury; Ear issue; Tenderness in the side of neck; This spontaneous case was reported by a consumer and describes the occurrence of LIMB INJURY (Left Shoulder injury), EAR DISORDER (Ear issue) and NECK PAIN (Tenderness in the side of neck) in a 52-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.    Co-suspect products included non-company products TOZINAMERAN (PFIZER BIONTECH COVID-19 VACCINE) for COVID-19 vaccination and ADALIMUMAB (HUMIRA) for Ulcerative colitis and Ankylosing spondylitis.    There was no reported medical history.    On 11-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 11-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. In October 2021, the patient received third dose of TOZINAMERAN (PFIZER BIONTECH COVID-19 VACCINE) (Intramuscular) 1 dosage form. On an unknown date, the patient started ADALIMUMAB (HUMIRA) (Subcutaneous) Citrate Free. In 2021, the patient experienced EAR DISORDER (Ear issue) and NECK PAIN (Tenderness in the side of neck). On an unknown date, the patient experienced LIMB INJURY (Left Shoulder injury). At the time of the report, LIMB INJURY (Left Shoulder injury), EAR DISORDER (Ear issue) and NECK PAIN (Tenderness in the side of neck) outcome was unknown.            Concomitant medications were not reported.  It was unknown if patient was enrolled in COVID-19 vaccine Trial. Treatment medications were not reported.   Reporter did not allow further contact
Sex: U
Vaccine: COVID19
Symptoms: Expired product administered
Clinical narrative: administered 2 days past the beyond use date; This spontaneous case was reported by a pharmacist and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (administered 2 days past the beyond use date) in a  patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 057M21A) for COVID-19 vaccination.     No Medical History information was reported.    On 26-May-2022, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) .25 milliliter. On 26-May-2022, the patient experienced EXPIRED PRODUCT ADMINISTERED (administered 2 days past the beyond use date). At the time of the report, EXPIRED PRODUCT ADMINISTERED (administered 2 days past the beyond use date) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   Beyond Use date was reported as 25-May-2022. It was reported that the product did not experienced any other temperature excursions and no particulates or discoloration noted. Suspect product was transported and maintained between 36-46F.  No concomitant medications were reported.  No treatment medications were reported.   This case was linked to MOD-2022-582105 (Patient Link).
Sex: U
Vaccine: COVID19
Symptoms: Expired product administered
Clinical narrative: Administered 2 days past the beyond use date; This spontaneous case was reported by a pharmacist and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Administered 2 days past the beyond use date) in a  patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 057M21A) for COVID-19 vaccination.     No Medical History information was reported.    On 27-May-2022, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) .25 milliliter. On 27-May-2022, the patient experienced EXPIRED PRODUCT ADMINISTERED (Administered 2 days past the beyond use date). At the time of the report, EXPIRED PRODUCT ADMINISTERED (Administered 2 days past the beyond use date) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   Beyond Use date was reported as 25 May 2022. It was reported that the product did not experienced any other temperature excursions and no particulates or discoloration noted. Suspect product was transported and maintained between 36-46F. No concomitant medications were reported. No treatment medications were reported.   This case was linked to MOD-2022-581911 (Patient Link).
Age: 71.0
Sex: M
Vaccine: COVID19
Symptoms: Expired product administered, Product storage error
Clinical narrative: Vaccine expired on 04-Apr-2022 and administered on 22-Apr-2022, doses were administered after the expiration date/Administered after 30-day use by date; This spontaneous case was reported by an other health care professional and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (doses were administered after the expiration date/Administered after 30-day use by date) and PRODUCT STORAGE ERROR (Vaccine expired on 04-Apr-2022 and administered on 22-Apr-2022.) in a 71-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 066H21A) for COVID-19 vaccination.     No Medical History information was reported.    On 22-Apr-2022, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 22-Apr-2022, the patient experienced EXPIRED PRODUCT ADMINISTERED (doses were administered after the expiration date/Administered after 30-day use by date). On an unknown date, the patient experienced PRODUCT STORAGE ERROR (Vaccine expired on 04-Apr-2022 and administered on 22-Apr-2022.). At the time of the report, EXPIRED PRODUCT ADMINISTERED (doses were administered after the expiration date/Administered after 30-day use by date) and PRODUCT STORAGE ERROR (Vaccine expired on 04-Apr-2022 and administered on 22-Apr-2022.) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No Concomitant product use was reported.  The reporter stated that vaccine their office administered were expired at the time of administration.  The vials were thawed on same day of administration and the vial didn't undergo any temperature excursions.  On 22-Apr-2022, the patient received first booster dose of expired Moderna vaccine.  The patient had no known reactions at office. The patient's weight was reported as 99 with unknown units.  No treatment information was provided.
Age: 43.0
Sex: F
Vaccine: COVID19
Symptoms: Expired product administered, Product storage error
Clinical narrative: Vaccine expired on 04-Apr-2022 and kept in the refrigerator on same day of administration; The vial was expired on 04-Apr-2022 and administered on 25-Apr-2022 and 25-May-2022; This spontaneous case was reported by an other health care professional and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (The vial was expired on 04-Apr-2022 and administered on 25-Apr-2022 and 25-May-2022) and PRODUCT STORAGE ERROR (Vaccine expired on 04-Apr-2022 and kept in the refrigerator on same day of administration) in a 43-year-old female patient who received mRNA-1273 (Spikevax) (batch nos. 066H21A and 066H21A) for COVID-19 vaccination.     No Medical History information was reported.   On 25-Apr-2022, the patient received first dose of mRNA-1273 (Spikevax) (unknown route) 1 dosage form. On 25-May-2022, received second dose of mRNA-1273 (Spikevax) (unknown route) dosage was changed to 1 dosage form. On 25-Apr-2022, the patient experienced EXPIRED PRODUCT ADMINISTERED (The vial was expired on 04-Apr-2022 and administered on 25-Apr-2022 and 25-May-2022). On an unknown date, the patient experienced PRODUCT STORAGE ERROR (Vaccine expired on 04-Apr-2022 and kept in the refrigerator on same day of administration). At the time of the report, EXPIRED PRODUCT ADMINISTERED (The vial was expired on 04-Apr-2022 and administered on 25-Apr-2022 and 25-May-2022) and PRODUCT STORAGE ERROR (Vaccine expired on 04-Apr-2022 and kept in the refrigerator on same day of administration) outcome was unknown. Not Provided      For mRNA-1273 (Spikevax) (Unknown), the reporter did not provide any causality assessments.   Patient weight was reported as 265. No concomitant medications were provided. The patient received 1st and 2nd dose.  HCP stated they administered expired doses of the Moderna COVID-19 Vaccine to 27 patients. Dose administered after 30-day Use By Date or after manufacturer date of expiry. The vial was initially stored in the refrigerator and was thawed same day of administration. The vials did not undergo any temperature excursions. No adverse events were reported. No treatment medications were provided.
Age: 63.0
Sex: M
Vaccine: COVID19
Symptoms: Expired product administered, Product storage error
Clinical narrative: vial first expired then stored in refrigerator on same date of administration; Vaccine was expired on 04-Apr-2022 and administered on 16-Apr-2022; This spontaneous case was reported by an other health care professional and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Vaccine was expired on 04-Apr-2022 and administered on 16-Apr-2022) and PRODUCT STORAGE ERROR (vial first expired then stored in refrigerator on same date of administration) in a 63-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 066H21A) for COVID-19 vaccination.     No Medical History information was reported.    On 16-Apr-2022, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 16-Apr-2022, the patient experienced EXPIRED PRODUCT ADMINISTERED (Vaccine was expired on 04-Apr-2022 and administered on 16-Apr-2022). On an unknown date, the patient experienced PRODUCT STORAGE ERROR (vial first expired then stored in refrigerator on same date of administration). At the time of the report, EXPIRED PRODUCT ADMINISTERED (Vaccine was expired on 04-Apr-2022 and administered on 16-Apr-2022) and PRODUCT STORAGE ERROR (vial first expired then stored in refrigerator on same date of administration) outcome was unknown. Not provided      For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   Patient weight was reported as 240. Concomitant medications were not reported. The patient had received 2nd booster dose. Patient had reported no adverse events. 28 patients might had received the expired Moderna COVID-19 vaccine. The vials were thawed the same day of administration. The vials did not undergo any temperature excursions. Treatment information was not reported.
Age: 73.0
Sex: F
Vaccine: COVID19
Symptoms: Expired product administered, Product storage error
Clinical narrative: Vaccine expired on 04-Apr-2022 and kept in the refrigrator on same day of administration; Vaccine was expired on 04-Apr-2022 and administered on 13-Apr-2022; This spontaneous case was reported by an other health care professional and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Vaccine was expired on 04-Apr-2022 and administered on 13-Apr-2022) and PRODUCT STORAGE ERROR (Vaccine expired on 04-Apr-2022 and kept in the refrigrator on same day of administration) in a 74-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 066H21A) for COVID-19 vaccination.     No Medical History information was reported.    On 13-Apr-2022, the patient received fourth dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 13-Apr-2022, the patient experienced EXPIRED PRODUCT ADMINISTERED (Vaccine was expired on 04-Apr-2022 and administered on 13-Apr-2022). On an unknown date, the patient experienced PRODUCT STORAGE ERROR (Vaccine expired on 04-Apr-2022 and kept in the refrigrator on same day of administration). At the time of the report, EXPIRED PRODUCT ADMINISTERED (Vaccine was expired on 04-Apr-2022 and administered on 13-Apr-2022) and PRODUCT STORAGE ERROR (Vaccine expired on 04-Apr-2022 and kept in the refrigrator on same day of administration) outcome was unknown. Not provided.      For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   Patient weight was reported as 180 Concomitant medications were not reported. Patient had received 2nd booster dose. Patient had reported no adverse events.28 patients may have received the expired Moderna COVID-19 vaccine The vials were thawed the same day of administration. The vials did not undergo any temperature excursions Treatment information was not reported.
Age: 76.0
Sex: M
Vaccine: COVID19
Symptoms: Expired product administered, Product storage error
Clinical narrative: Vaccine expired on 04-Apr-2022 and kept in the refrigrator on same day of administration; Doses were administered after the expiration date; This spontaneous case was reported by an other health care professional and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Doses were administered after the expiration date) and PRODUCT STORAGE ERROR (Vaccine expired on 04-Apr-2022 and kept in the refrigrator on same day of administration) in a 76-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 066H21A) for COVID-19 vaccination.     No Medical History information was reported.    On 20-Apr-2022, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 20-Apr-2022, the patient experienced EXPIRED PRODUCT ADMINISTERED (Doses were administered after the expiration date). On an unknown date, the patient experienced PRODUCT STORAGE ERROR (Vaccine expired on 04-Apr-2022 and kept in the refrigrator on same day of administration). At the time of the report, EXPIRED PRODUCT ADMINISTERED (Doses were administered after the expiration date) and PRODUCT STORAGE ERROR (Vaccine expired on 04-Apr-2022 and kept in the refrigrator on same day of administration) outcome was unknown. Not provided      For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   Patient weight was reported as 175. No concomitant medications were reported. Total number doses were 27, vial was initially stored in the refrigerator and thawed same day of administration. vial  did not undergo any temperature excursions. It was reported that there were no known reactions. No treatment medications were reported.
Age: 64.0
Sex: F
Vaccine: COVID19
Symptoms: Expired product administered, Product storage error
Clinical narrative: Vials were stored in refrigerator even after expiration date/vials were stored in the refrigerator and thawed on same day of administration; Vaccine was administered on 13 Apr 2022 and expired on 04 Apr 2022.; This spontaneous case was reported by an other health care professional and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Vaccine was administered on 13 Apr 2022 and expired on 04 Apr 2022.) and PRODUCT STORAGE ERROR (Vials were stored in refrigerator even after expiration date/vials were stored in the refrigerator and thawed on same day of administration) in a 65-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 066H21A) for COVID-19 vaccination.     No Medical History information was reported.    On 13-Apr-2022, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 13-Apr-2022, the patient experienced EXPIRED PRODUCT ADMINISTERED (Vaccine was administered on 13 Apr 2022 and expired on 04 Apr 2022.). On an unknown date, the patient experienced PRODUCT STORAGE ERROR (Vials were stored in refrigerator even after expiration date/vials were stored in the refrigerator and thawed on same day of administration). At the time of the report, EXPIRED PRODUCT ADMINISTERED (Vaccine was administered on 13 Apr 2022 and expired on 04 Apr 2022.) and PRODUCT STORAGE ERROR (Vials were stored in refrigerator even after expiration date/vials were stored in the refrigerator and thawed on same day of administration) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant medication were reported.  The weight of patient was reported as 180.  Patient received second booster. Date the vial was initially stored in the refrigerator, was the same day vials were thawed. The vial did not undergo any temperature excursions. It was reported that patient did not experienced any known reactions.  No treatment medication were reported.
Age: 53.0
Sex: F
Vaccine: COVID19
Symptoms: Expired product administered, Product storage error
Clinical narrative: Vaccine was expired on 04-Apr-2022 and administered on 17-May-2022; Vaccine was expired on 04-Apr-2022 and administered on 17-May-2022; This spontaneous case was reported by an other health care professional and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Vaccine was expired on 04-Apr-2022 and administered on 17-May-2022) and PRODUCT STORAGE ERROR (Vaccine was expired on 04-Apr-2022 and administered on 17-May-2022) in a 53-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 066H21A) for COVID-19 vaccination.     No Medical History information was reported.    On 17-May-2022, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 17-May-2022, the patient experienced EXPIRED PRODUCT ADMINISTERED (Vaccine was expired on 04-Apr-2022 and administered on 17-May-2022). On an unknown date, the patient experienced PRODUCT STORAGE ERROR (Vaccine was expired on 04-Apr-2022 and administered on 17-May-2022). At the time of the report, EXPIRED PRODUCT ADMINISTERED (Vaccine was expired on 04-Apr-2022 and administered on 17-May-2022) and PRODUCT STORAGE ERROR (Vaccine was expired on 04-Apr-2022 and administered on 17-May-2022) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No Concomitant product use was reported.  The reporter stated that vaccine their Office administered were expired at the time of administration.  The vials were thawed on same day of administration and the vial didn't undergo any temperature excursions.  On 17-May-2022, the patient received first booster dose of expired vaccine.  The patient had no known reactions at office. No treatment information was provided.
Age: 67.0
Sex: F
Vaccine: COVID19
Symptoms: Expired product administered, Product storage error
Clinical narrative: vials were stored in the refrigerator and thawed on same day of administration; Vaccine was expired on 04-Apr-2022 and administered on 26-Apr-2022; This spontaneous case was reported by an other health care professional and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Vaccine was expired on 04-Apr-2022 and administered on 26-Apr-2022) and PRODUCT STORAGE ERROR (vials were stored in the refrigerator and thawed on same day of administration) in a 67-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 066H21A) for COVID-19 vaccination.     No Medical History information was reported.    On 26-Apr-2022, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 26-Apr-2022, the patient experienced EXPIRED PRODUCT ADMINISTERED (Vaccine was expired on 04-Apr-2022 and administered on 26-Apr-2022). On an unknown date, the patient experienced PRODUCT STORAGE ERROR (vials were stored in the refrigerator and thawed on same day of administration). At the time of the report, EXPIRED PRODUCT ADMINISTERED (Vaccine was expired on 04-Apr-2022 and administered on 26-Apr-2022) and PRODUCT STORAGE ERROR (vials were stored in the refrigerator and thawed on same day of administration) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   Patient weight was reported as 240.  Concomitant medications were not reported.  On 26-Apr-2022, the patient received a first booster dose (Lot: 066H21A) of Moderna vaccine.  Reported that doses were administered after the expiration date/Administered after 30-day use by date. It was reported that patient didn't experienced any known reactions. The vials were thawed the same day of administration. The vials did not undergo any temperature excursions.  Treatment information was not reported.
Age: 47.0
Sex: M
Vaccine: COVID19
Symptoms: Expired product administered, Product storage error
Clinical narrative: Vaccine expired on 04-Apr-2022 and kept in the refrigerator on same day of administration; Doses were administered after the expiration date; This spontaneous case was reported by an other health care professional and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Doses were administered after the expiration date) and PRODUCT STORAGE ERROR (Vaccine expired on 04-Apr-2022 and kept in the refrigerator on same day of administration) in a 47-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 066H21A) for COVID-19 vaccination.     No Medical History information was reported.    On 06-May-2022, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 06-May-2022, the patient experienced EXPIRED PRODUCT ADMINISTERED (Doses were administered after the expiration date). On an unknown date, the patient experienced PRODUCT STORAGE ERROR (Vaccine expired on 04-Apr-2022 and kept in the refrigrator on same day of administration). At the time of the report, EXPIRED PRODUCT ADMINISTERED (Doses were administered after the expiration date) and PRODUCT STORAGE ERROR (Vaccine expired on 04-Apr-2022 and kept in the refrigrator on same day of administration) outcome was unknown. Not provided.     For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant medication were reported. Patient weight has been reported as 185. HCP stated they administered expired doses of the Moderna COVID-19 Vaccine to 27 patients. Dose administered after 30-day Use By Date or after manufacturer date of expiry. Date the vial was initially stored in the refrigerator, was the same day vials were thawed. The vial didn't undergo any temperature excursions No treatment information were provided.
Age: 47.0
Sex: F
Vaccine: COVID19
Symptoms: Expired product administered
Clinical narrative: doses were administered after the expiration date; This spontaneous case was reported by an other health care professional and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (doses were administered after the expiration date) in a 47-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 066H21A) for COVID-19 vaccination.     No Medical History information was reported.    On 06-May-2022, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 06-May-2022, the patient experienced EXPIRED PRODUCT ADMINISTERED (doses were administered after the expiration date). At the time of the report, EXPIRED PRODUCT ADMINISTERED (doses were administered after the expiration date) outcome was unknown. Not provided      For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   Patient weight was reported as 160. No concomitant medications were reported. Total number doses were 27 , vial was initially stored in the refrigerator and thawed same day of administration. Vial  did not undergo any temperature excursions. No treatment medications were reported
Sex: F
Vaccine: COVID19
Symptoms: Feeling abnormal, Skin disorder
Clinical narrative: So I'm kind of floating out there; My skin is a total mess, I am having an awful problem with my skin. This spontaneous case was reported by a patient and describes the occurrence of SKIN DISORDER (My skin is a total mess, I am having an awful problem with my skin.) and FEELING ABNORMAL (So I'm kind of floating out there) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.   On an unknown date, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form and first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. In November 2021, the patient experienced SKIN DISORDER (My skin is a total mess, I am having an awful problem with my skin.). On an unknown date, the patient experienced FEELING ABNORMAL (So I'm kind of floating out there). At the time of the report, SKIN DISORDER (My skin is a total mess, I am having an awful problem with my skin.) had not resolved and FEELING ABNORMAL (So I'm kind of floating out there) outcome was unknown.            No concomitant drug information was provided. It was reported that the patient had an issue with her skin after receiving the booster. The patient had received the booster shot six months after the primary series. Patient had seen a dermatologist. It was reported that the patient would never go back to the dermatologist and had lost the primary care.    Treatment drug information was not provided.
Age: 26.0
Sex: F
Vaccine: COVID19, UNK
Symptoms: Anxiety, Feeling abnormal, Insomnia
Clinical narrative: Felt like patient was going crazy/Feeling abnormal; Terrible Insomnia; Anxiety going through the roof; This spontaneous case was reported by a consumer and describes the occurrence of FEELING ABNORMAL (Felt like patient was going crazy/Feeling abnormal), INSOMNIA (Terrible Insomnia) and ANXIETY (Anxiety going through the roof) in a 26-year-old female patient who received mRNA-1273 (Spikevax) for COVID-19 vaccination.    Co-suspect product included non-company product ELAGOLIX SODIUM (ORILISSA) for an unknown indication.    No Medical History information was reported.   On 13-Apr-2022, the patient started ELAGOLIX SODIUM (ORILISSA) (Oral) at an unspecified dose. On an unknown date, the patient received first dose of mRNA-1273 (Spikevax) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced FEELING ABNORMAL (Felt like patient was going crazy/Feeling abnormal), INSOMNIA (Terrible Insomnia) and ANXIETY (Anxiety going through the roof). At the time of the report, FEELING ABNORMAL (Felt like patient was going crazy/Feeling abnormal), INSOMNIA (Terrible Insomnia) and ANXIETY (Anxiety going through the roof) had not resolved.        The action taken with mRNA-1273 (Spikevax) (Intramuscular) was unknown.       No concomitant medications were provided by the reporter  In 2022 the patient had experienced the events Feeling abnormal, Insomnia & Anxiety  No treatment medications were provided by the reporter
Age: 55.0
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, Drug ineffective, SARS-CoV-2 test
Clinical narrative: COVID 19 Treatment; COVID 19 Treatment; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 56-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 24Mar2022 as dose single, unknown (Batch/Lot number: unknown) at the age of 55 years, in left arm for covid-19 immunisation. The patient had no relevant medical history. There were no concomitant medications. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant), outcome "unknown" and all described as "COVID 19 Treatment". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (unspecified date) Negetive, notes: After testing negative for 5 days; (23May2022) positive, notes: my COVID came back. Therapeutic measures were taken as a result of drug ineffective, covid-19.  The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.