chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 7.0
Sex: M
Vaccine: COVID19
Symptoms: Magnetic resonance imaging head normal, Magnetic resonance imaging neck, Magnetic resonance imaging spinal abnormal, Neurological examination, Occult blood negative
Clinical narrative: Patient received second dose of COVID-19 vaccine (Pfizer) on 11/30/21. He did not have any notable local or systemic reactions and was in his usual state of health, even participating in his tae kwon do classess until 12/4/21, when he developed new back pain. On 12/5, pain worsened to the point that he had difficulty walking as well as worsening urinary retention, prompting admission to the hospital for further workup. He underwent extensive workup from 12/5-12/12 (summarized in Item 19), all of which was inconclusive. However, his clinical exam improved while inpatient, so he was subsequently discharged with supportive care and outpatient PT.  Repeat MRI 3/7/22 demonstrated a substle T2 hyperintense signal abnormality at the left lateral cord from C6-T1 as well as a tiny C5-C6 annular tear, most suggestive of a spinal cord infarct. Underwent cryptogenic stroke evaluation with repeat head/spine and vessel imaging as well as serum studies, that were not suggestive of other underlying cause of spinal stroke. Leading suspicion is that his presentation was due to a fibrocartilagenous embolism.  He clinically continued to improve over the next several months to the point where he no longer had urinary retention and no weakness was detectable on his neurologic exam as of 03/2022. He does continue to have hyperreflexia.
Age: 7.0
Sex: M
Vaccine: COVID19
Symptoms: Polymerase chain reaction, Protein C, Protein S normal, Prothrombin time prolonged, Scan with contrast
Clinical narrative: Patient received second dose of COVID-19 vaccine (Pfizer) on 11/30/21. He did not have any notable local or systemic reactions and was in his usual state of health, even participating in his tae kwon do classess until 12/4/21, when he developed new back pain. On 12/5, pain worsened to the point that he had difficulty walking as well as worsening urinary retention, prompting admission to the hospital for further workup. He underwent extensive workup from 12/5-12/12 (summarized in Item 19), all of which was inconclusive. However, his clinical exam improved while inpatient, so he was subsequently discharged with supportive care and outpatient PT.  Repeat MRI 3/7/22 demonstrated a substle T2 hyperintense signal abnormality at the left lateral cord from C6-T1 as well as a tiny C5-C6 annular tear, most suggestive of a spinal cord infarct. Underwent cryptogenic stroke evaluation with repeat head/spine and vessel imaging as well as serum studies, that were not suggestive of other underlying cause of spinal stroke. Leading suspicion is that his presentation was due to a fibrocartilagenous embolism.  He clinically continued to improve over the next several months to the point where he no longer had urinary retention and no weakness was detectable on his neurologic exam as of 03/2022. He does continue to have hyperreflexia.
Age: 7.0
Sex: M
Vaccine: COVID19
Symptoms: Spinal disorder, Spinal stroke, Urinary retention, Vitamin B12 normal, Von Willebrand's factor activity normal
Clinical narrative: Patient received second dose of COVID-19 vaccine (Pfizer) on 11/30/21. He did not have any notable local or systemic reactions and was in his usual state of health, even participating in his tae kwon do classess until 12/4/21, when he developed new back pain. On 12/5, pain worsened to the point that he had difficulty walking as well as worsening urinary retention, prompting admission to the hospital for further workup. He underwent extensive workup from 12/5-12/12 (summarized in Item 19), all of which was inconclusive. However, his clinical exam improved while inpatient, so he was subsequently discharged with supportive care and outpatient PT.  Repeat MRI 3/7/22 demonstrated a substle T2 hyperintense signal abnormality at the left lateral cord from C6-T1 as well as a tiny C5-C6 annular tear, most suggestive of a spinal cord infarct. Underwent cryptogenic stroke evaluation with repeat head/spine and vessel imaging as well as serum studies, that were not suggestive of other underlying cause of spinal stroke. Leading suspicion is that his presentation was due to a fibrocartilagenous embolism.  He clinically continued to improve over the next several months to the point where he no longer had urinary retention and no weakness was detectable on his neurologic exam as of 03/2022. He does continue to have hyperreflexia.
Age: 7.0
Sex: M
Vaccine: COVID19
Symptoms: Von Willebrand's factor antigen normal
Clinical narrative: Patient received second dose of COVID-19 vaccine (Pfizer) on 11/30/21. He did not have any notable local or systemic reactions and was in his usual state of health, even participating in his tae kwon do classess until 12/4/21, when he developed new back pain. On 12/5, pain worsened to the point that he had difficulty walking as well as worsening urinary retention, prompting admission to the hospital for further workup. He underwent extensive workup from 12/5-12/12 (summarized in Item 19), all of which was inconclusive. However, his clinical exam improved while inpatient, so he was subsequently discharged with supportive care and outpatient PT.  Repeat MRI 3/7/22 demonstrated a substle T2 hyperintense signal abnormality at the left lateral cord from C6-T1 as well as a tiny C5-C6 annular tear, most suggestive of a spinal cord infarct. Underwent cryptogenic stroke evaluation with repeat head/spine and vessel imaging as well as serum studies, that were not suggestive of other underlying cause of spinal stroke. Leading suspicion is that his presentation was due to a fibrocartilagenous embolism.  He clinically continued to improve over the next several months to the point where he no longer had urinary retention and no weakness was detectable on his neurologic exam as of 03/2022. He does continue to have hyperreflexia.
Age: 14.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Chest pain, Laboratory test, Myocarditis, Troponin increased
Clinical narrative: Patient had chest pain and nausea 1 day after vaccine administration.
Age: 14.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Brain natriuretic peptide increased, Chest pain, Echocardiogram, Electrocardiogram, Immunoglobulin therapy
Clinical narrative: Patient had chest pain and nausea 1 day after vaccine administration.
Age: 14.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Myocardial necrosis marker increased, Nausea, Troponin increased
Clinical narrative: Patient had chest pain and nausea 1 day after vaccine administration.
Age: 2.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Incorrect dose administered, No adverse event, Product administered to patient of inappropriate age
Clinical narrative: MEDICAL PERSONAL INFORM ME AFTER 20 MINUTES AFTER VACCINATION THAT BY MISTAKE THEY ADMINISTER A FULL ADULT DOSE TO MY 2 YEAR OLD
Age: 2.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Incorrect dose administered
Clinical narrative: MEDICAL PERSONAL INFORM ME AFTER 20 MINUTES AFTER VACCINATION THAT BY MISTAKE THEY ADMINISTER A FULL ADULT DOSE TO MY 2 YEAR OLD
Age: 0.17
Sex: U
Vaccine: MMRV
Symptoms: No adverse event, Product administered to patient of inappropriate age
Clinical narrative: No additional AE reported; a 2 month old infant was inadvertently administered a dose of PROQUAD; This spontaneous report was received from a physician, referring to a 2 months old patient. The patient's medical history and concurrent condition were not provided. Concomitant medication included sterile diluent.      On 26-MAY-2022, the patient was inadvertently vaccinated with measles, mumps, rubella and varicella (oka-merck) virus vaccine live (PROQUAD) (lot # U031563, expiration date 06-APR-2023; strength, dose number and route were not reported) at dose of 0.5 milliliter for prophylaxis (product administered to patient of inappropriate age). No additional adverse event (AE) reported.
Sex: U
Vaccine: MMRV
Symptoms: No adverse event, Product storage error
Clinical narrative: No additional AE reported; A patient was administered PROQUAD after a temperature excursion.; This spontaneous report was received from a medical assistant concerning a patient of unknown age and gender. The patient's medical history, concurrent conditions and concomitant medications were not reported.  On 25-MAY-2022, the patient was vaccinated an improperly stored dose of measles, mumps, rubella and varicella (oka-merck) virus vaccine live (PROQUAD) lot number U024508 with expiration date: 02-FEB-2023, as prophylaxis (dose, vaccination scheme frequency, anatomical location, and route of administration were not reported). The vaccine suffered a temperature excursion at 8.3 fahrenheit (F) degrees for 15 minutes (product storage error). There were no previous temperature excursions. No adverse event was reported.  ; Sender's Comments:  US-009507513-2206USA000886: US-009507513-2206USA000990:
Sex: U
Vaccine: MMR
Symptoms: Expired product administered
Clinical narrative: No additional AEs; expired dose of MMR II administered; This spontaneous report was received from a physician and referred to a patient of unknown age and gender. The patient's medical history, concurrent conditions and concomitant therapies were not reported.  On 02-JUN-2022, the patient was vaccinated with the expired dose of measles, mumps, and rubella (wistar ra 27-3) virus vaccine, live (recombinant Human albumin) (rHA))(M-M-R II) subcutaneous injection, 0.5 milliliter, subcutaneously for prophylaxis (lot # was T018669, expiration date was reported as 29-MAY-2022; strength was not provided) (expired product administered). No additional adverse events were reported (no adverse event).
Sex: U
Vaccine: VARCEL
Symptoms: Product storage error
Clinical narrative: No additional AE reported; Nurse reporting that one patient was administered VARIVAX after experiencing a temperature excursion (Temperature: 6.6F); This spontaneous report was received from a nurse and referred to a patient of unknown age and gender. The patient's medical history, concurrent conditions and concomitant therapies were not reported.  On 16-MAY-2022, the patient was vaccinated with varicella virus vaccine live (oka/merck) (VARIVAX) subcutaneous injection after experiencing a temperature excursion (temperature: 6.6F; time frame: 0 hours 5 minutes and 0 seconds) for prophylaxis (lot # U019908 is valid upon internal validation, expiration date: 24-JUN-2023; strength, dose, and route of administration were not provided) (product storage error). No additional adverse event was reported (no adverse event).
Age: 5.0
Sex: U
Vaccine: MMRV
Symptoms: Product storage error
Clinical narrative: Nurse calling for TE evaluation on frozen products states products have been administered; no adverse event; This spontaneous report has been received from a nurse, concerning 5 years old patient of unknown gender. The patient's pertinent medical history, concurrent conditions, previous drug reactions and allergies were not provided. Concomitant medications included sterile diluent.  On an unknown date, the patient was administered vaccine measles, mumps, rubella, and varicella (oka-merck) virus vaccine live, recombinant human albumin (rHa) (PROQUAD) subcutaneous injection (valid lot number W004029 [expiration date 01-AUG-2023]) (dose, vaccination scheme, and frequency were not provided) for prophylaxis. The vaccine was exposed to the temperature excursions: 6 degrees Fahrenheit (F) up to 14 degrees F with average 8 F for 18 minutes (min), 14 F up to 46 F with average 18.40 F for 45 min (product storage error). No previous temperature excursion was reported. No additional adverse event (AE) details.; Sender's Comments:  US-009507513-2206USA002231: US-009507513-2206USA002264:
Sex: U
Vaccine: PPV
Symptoms: Product storage error
Clinical narrative: No additional AE details or PQC.; PNEUMOVAX 23 was inadvertently administered after a non-supported temp excursion; This spontaneous report as received from a healthcare business, referring to a patient of unknown age and gender. The patient's pertinent medical history, current condition, previous drug reaction or allergy, and concomitant medication were not reported.  On 11-APR-2022, the patient was vaccinated with improperly stored pneumococcal vaccine, polyvalent (23-valent)(PNEUMOVAX23) injection (strength, dose, route of administration and anatomical site of vaccination were not reported, lot number U022819, expiration date reported and validated as 14-JAN-2024) for prophylaxis (product storage error). The vaccine was exposed to the temperature excursions: 70 degrees Fahrenheit for 96 hours. There was no previous temperature excursion. No additional adverse event details.
Sex: U
Vaccine: PPV
Symptoms: No adverse event, Product storage error
Clinical narrative: No additional AEs or PQC reported; vaccine administered after temperature excursion; This spontaneous report was received from a medical assistant, referring to a patient of unknown age and gender. The patient's pertinent medical history, current condition, previous drug reaction or allergy, and concomitant medication were not reported.  On 07-JUN-2022, the patient was vaccinated with improperly stored pneumococcal vaccine, polyvalent (23-valent)(PNEUMOVAX23) injection (strength, anatomical site of vaccination were not reported, 0.5 ml, lot number U034712, expiration date reported and validated as 30-Jul-2023) intramuscular (IM) for prophylaxis (product storage error). The vaccine was exposed to the temperature excursions: 34.2 degrees Fahrenheit for 12 hours. There was no previous temperature excursion. No additional adverse events.
Age: 17.0
Sex: U
Vaccine: MMRV
Symptoms: No adverse event, Product administered to patient of inappropriate age
Clinical narrative: No additional adverse events.; Caller is nurse who reported that PROQUAD was given to a 17 year old patient.; This spontaneous report was received from a registered nurse, concerning a 17-year-old patient of unknown gender. The patient's pertinent medical history, concurrent conditions, previous drug reactions and allergies and concomitant medications were not provided.   On an unknown date, the patient was administered vaccine measles, mumps, rubella, and varicella (oka-merck) virus vaccine live, recombinant human albumin (rHa) (PROQUAD) subcutaneous injection (1 dose, valid lot number W007743 [expiration date 04-SEP-2023]) (dose, strength and route were not provided) for prophylaxis at 17 years old (product administered to patient of inappropriate age). No additional information available. No additional adverse events. No product quality complaints.
Sex: U
Vaccine: MMR
Symptoms: Expired product administered, No adverse event
Clinical narrative: No additional AEs; Caller reports expired vaccine administered; This spontaneous report was received from a medical assistant and referred to a patient of unknown age and gender. The patient's medical history and concurrent conditions were not reported. Concomitant medication was sterile diluent (manufacturer unknown).  On 10-JUN-2022, the patient was vaccinated with measles, mumps, and rubella (wistar ra 27-3) virus vaccine, live (M-M-R II) (therapy type was rHA) subcutaneous injection, 0.5 milliliter, subcutaneously (SQ) for prophylaxis (lot #T018892, expiration date: 02-JUN-2022, strength was not provided) (expired product administered). No additional adverse event was reported (no adverse event).
Age: 18.0
Sex: F
Vaccine: HPV9, MENB
Symptoms: Peripheral swelling, Urticaria
Clinical narrative: hives on her collar bone/hives around her eyes, the hives occur mostly around her left eye, in the corner and little bit on the eyelid of that eye/hives only occur on the arm where her daughter received the BEXSERO; swelling in her right arm; This spontaneous report was received from a consumer referring to a 18-year-old female patient.  Concomitant medication and pertinent medical history were none. The patient was allergic to penicillin and cefdinir.  On 31-MAY-2022, the patient was vaccinated with hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast) (GARDASIL 9) injection in the left arm for cancer prevention (strength, dose, lot #, expiry date, and route of administration were not provided). On the same date, the patient also received meningococcal vaccine b rfhbp/nada/nhba omv (BEXSERO) in the right arm for prophylaxis (strength, dose, formulation, lot #, expiry date, and route of administration were not provided).  Afterwards, on the same date, the patient experienced swelling in her right arm. Within 36 hours after receiving the vaccines, the patient developed hives on her collar bone and 24 hours after that, she developed hives around her eyes. Caller stated that the hives occur mostly around her left eye, in the corner and little bit on the eyelid of that eye. Caller stated that since then, her daughter has been experiencing these hives every 24 to 48 hours, and they pop up and then disappeared after some time before coming back again. It was also stated that the hives only occurred on the arm where the patient received the meningococcal vaccine b rfhbp/nada/nhba omv (BEXSERO). The hives were not huge, and they were small and dime-sized. The patient also only experienced the swelling in her right arm. The patient did not receive treatment for the events. Outcome of the events were not resolved.  The reporter wanted to know if hives were a common adverse reaction to the  hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast) (GARDASIL 9) vaccine. She also wanted to know if hives were considered an allergic reaction and inquired about whether or not the patient should continue the series.  The causality assessment was not reported.
Sex: U
Vaccine: HPV9
Symptoms: Product storage error
Clinical narrative: Medical assistant calling to report administered vaccine temperature excursion on multiple patients.; This spontaneous report was received from a medical assistant and referred to a patient of unknown age and gender. Concomitant medication, pertinent medical history and drug reactions/allergies were not reported.  On 13-JUN-2022, the patient was vaccinated with improperly stored hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast) (GARDASIL 9) injection, 1 injection, lot # 1780867, expiration date was reported as 20-AUG-2023, upon internal validation established as 08-AUG-2023, administered for prophylaxis (strength, and route of administration were not provided) (product storage error).  It was reported that the vaccine went out of range on 13-JUN-2022 (reported as "yesterday") and it was not discovered until the morning on 14-JUN-2022 when checking the data logger.  This is one of the cases reported by the same reporter. ; Sender's Comments:  US-009507513-2206USA004511:
Sex: U
Vaccine: MMRV
Symptoms: Product storage error
Clinical narrative: improperly stored vaccines; No additional AE information; This spontaneous report was received from a Health business professional, concerning a currently 4-year-old patient of unknown gender. The patient's pertinent medical history, concurrent conditions, previous drug reactions and allergies and concomitant medications were not provided.  On an unknown date, the patient was administered improper stored vaccine measles, mumps, rubella, and varicella (oka-merck) virus vaccine live, recombinant human albumin (rHa) (PROQUAD) subcutaneous injection (valid lot number U022727 [expiration date 16-JAN-2023]) (dose, strength, and route were not provided) for prophylaxis. The vaccine was exposed to the temperature excursions: 6 degrees Fahrenheit (F) up to 14 degrees F (-14 degree Celsius up to -10 degree Celsius) -11.6 for 30 minutes (product storage error). There was no previous temperature excursion. No additional adverse event (AE) information.
Sex: U
Vaccine: MMRV
Symptoms: Product storage error
Clinical narrative: Health business professional calling to report AE for improperly stored vaccines.; No additional AE information; This spontaneous report was received from a health business professional and referred to a patient of unknown gender, currently was 5-year-old.  The patient's concomitant therapies, pertinent medical history and drug reactions/allergies were not reported.  On an unknown date, the patient was vaccinated with improperly stored measles, mumps, rubella and varicella (oka-merck) virus vaccine live recombinant human albumin (rHA))(PROQUAD) subcutaneous injection (lot #U022727, expiration date: 16-JAN-2023), administered for prophylaxis (strength, dose, and route of administration were not provided) (product storage error).  It was reported that the suspect vaccine was exposed to a temperature of 6 Fahrenheit (F) up to 14 F (minus 14 degree Celsius up to minus 10 degree Celsius) minus 11.6 for a time frame for 30 minutes. There were no previous temperature excursions.   No additional adverse event (AE) information was provided.; Sender's Comments:  US-009507513-2206USA004540:
Sex: U
Vaccine: HPV9
Symptoms: Expired product administered
Clinical narrative: No other adverse events reported.; An expired dose of GARDASIL 9 was administered to a patient yesterday.; This spontaneous report was received from pharmacist and refers to a patient of unknown gender and age.  The patient's medical history, concurrent conditions, concomitant medications, and previous drug reactions or allergies were not reported.   On 16-JUN-2022, the patient was vaccinated with an expired HPV rL1 6 11 16 18 31 33 45 52 58 VLP vaccine (yeast)  (GARDASIL 9) injection, one dose, administered as prophylaxis (lot number 1621926 which has been verified to be valid, expiration date reported and validated as 28-NOV-2021) (strength, dosage, route of administration and anatomical site of injection were not reported) (expired product administered).   Also, the reporter mentioned that the dose was properly stored up through the time of administration. No other adverse events were reported in the patient.
Sex: U
Vaccine: RV5
Symptoms: Product storage error
Clinical narrative: No additional AEs or PQC reported; ROTATEQ administered after temperature excursion; This spontaneous report was received from a medical assistant referring to a patient of unknown age and gender. Information about pertinent medical history, drug reaction/allergy and concomitant medication was not provided.   On an unknown date, rotavirus vaccine, live, oral, pentavalent (ROTATEQ) experienced temperature excursion with 49.8 Fahrenheit degrees for 2 hours. There was no previous temperature excursion.    On 20-JUN-2022, the patient was vaccinated with the improperly stored rotavirus vaccine, live, oral, pentavalent (ROTATEQ) (2 ml, lot# U006165, expiration date 18-OCT-2022; strength was not reported) orally for prophylaxis (product storage error). No additional adverse events (AEs) or product quality complaint (PQC) was reported.
Sex: U
Vaccine: PPV
Symptoms: Product storage error
Clinical narrative: No additional AE reported; the PNEUMOVAX 23 was administered to the patient after the excursion occurred; This spontaneous report was received from a registered nurse referring to a patient of unknown age and gender. The patient's concurrent conditions, medical history, drug reactions/allergies and concomitant therapies were not reported.  On 15-MAR-2022, the patient was vaccinated with improper stored pneumococcal vaccine, polyvalent (23-valent) (PNEUMOVAX23) lot #U022819, expiration date: 14-JAN-2023 (dose, and route of administration were not provided), administered for prophylaxis (Product storage error).   The administered dose of the vaccine experienced a temperature excursion in 1.7 degrees Celsius for 24 hours. There was previous temperature excursion. No additional adverse event (AE) reported.  This is one of several reports received from the same reporter. ; Sender's Comments:  US-009507513-2206USA006587: US-009507513-2206USA006432: US-009507513-2206USA006670: US-009507513-2206USA006674: US-009507513-2206USA006731: US-009507513-2206USA006852: US-009507513-2206USA006952: US-009507513-2206USA006981: US-009507513-2206USA007045: US-009507513-2206USA007059: US-009507513-2206USA007068: US-009507513-2206USA007070: US-009507513-2206USA007090: US-009507513-2206USA007094: US-009507513-2206USA007098:
Age: 73.0
Sex: F
Vaccine: COVID19
Symptoms: Expired product administered, Product storage error
Clinical narrative: The vaccine expired in the freezer on 6Apr2022/ Type of dose gave after expiration date and date Second booster/ Date the vial was initially stored in the refrigerator*: 28Apr2022, and 4Apr2022; administer expired vaccine; This spontaneous case was reported by a nurse and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (administer expired vaccine) and PRODUCT STORAGE ERROR (The vaccine expired in the freezer on 6Apr2022/ Type of dose gave after expiration date and date Second booster/ Date the vial was initially stored in the refrigerator*: 28Apr2022, and 4Apr2022) in a 74-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 067F21A) for COVID-19 prophylaxis.     Patient had no allergies to medications,food and other products.Patient was neither tested nor diagnosed with COVID and had no acute and chronic illnesses at the time of vaccination.    On 29-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 26-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 28-Oct-2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 16-May-2022, received fourth dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 16-May-2022,  after starting mRNA-1273 (Moderna COVID-19 Vaccine), the patient experienced EXPIRED PRODUCT ADMINISTERED (administer expired vaccine). On an unknown date, the patient experienced PRODUCT STORAGE ERROR (The vaccine expired in the freezer on 6Apr2022/ Type of dose gave after expiration date and date Second booster/ Date the vial was initially stored in the refrigerator*: 28Apr2022, and 4Apr2022). At the time of the report, EXPIRED PRODUCT ADMINISTERED (administer expired vaccine) and PRODUCT STORAGE ERROR (The vaccine expired in the freezer on 6Apr2022/ Type of dose gave after expiration date and date Second booster/ Date the vial was initially stored in the refrigerator*: 28Apr2022, and 4Apr2022) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   It was unknown whether patient received other vaccines within 1 month prior to Modena COVID-19 vaccine. No concomitant medications were reported. The number of doses were at least 10 vials. Dose administered after 30-day Use By Date or after manufacturer date of expiry. On 28-Apr-2022 and 04-Apr-2022, the vials were stored in the refrigerator. The vials did not underwent any temperature excursions. It was unknown whether the AE caused patient to seek medical care. It was unknown whether patient experienced similar event in the past.   This case was linked to MOD-2022-593844, MOD-2022-593857 (Patient Link).
Sex: F
Vaccine: COVID19
Symptoms: Illness
Clinical narrative: Reporter neighbors stated that she was so sick from the vaccine.; This spontaneous case was reported by a consumer and describes the occurrence of ILLNESS (Reporter neighbors stated that she was so sick from the vaccine.) in a female patient of an unknown age who received mRNA-1273 (Spikevax) for COVID-19 prophylaxis.     No Medical History information was reported.    On an unknown date, the patient received dose of mRNA-1273 (Spikevax) (unknown route) 1 dosage form. On 23-Jun-2022, the patient experienced ILLNESS (Reporter neighbors stated that she was so sick from the vaccine.). At the time of the report, ILLNESS (Reporter neighbors stated that she was so sick from the vaccine.) outcome was unknown.        The action taken with mRNA-1273 (Spikevax) (Unknown) was unknown.       No concomitant information was reported. No treatment information was provided.
Age: 57.0
Sex: M
Vaccine: COVID19
Symptoms: Expired product administered
Clinical narrative: Patient was administered with vaccine that was beyond use date after the thaw process; This spontaneous case was reported by a paramedic and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Patient was administered with vaccine that was beyond use date after the thaw process) in a 57-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 027H21B) for COVID-19 prophylaxis.     No Medical History information was reported.    On 28-Dec-2021, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) .25 milliliter. On 28-Dec-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (Patient was administered with vaccine that was beyond use date after the thaw process). At the time of the report, EXPIRED PRODUCT ADMINISTERED (Patient was administered with vaccine that was beyond use date after the thaw process) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   It was reported that the age of patient was 57 years 10 months. No concomitant medications were reported It was unknown if patient had acute illness at the time of vaccination and up to one month before. It was unknown if patient had been diagnosed with or tested positive for COVID-19, nor if patient had chronic or long lasting health conditions. It was reported that patient had no adverse reactions after the administration of vaccine. No treatment medication were reported. The vaccination facility was made aware of administration of vaccines beyond use date after the thaw process while audit was conducted. Patient got Moderna with vaccine Ndc code.
Age: 63.0
Sex: M
Vaccine: COVID19
Symptoms: Expired device used
Clinical narrative: Vaccine that administered beyond use date after the thaw process/expired vaccine administered; This spontaneous case was reported by a paramedic and describes the occurrence of EXPIRED DEVICE USED (Vaccine that administered beyond use date after the thaw process/expired vaccine administered) in a 63-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 027H21B) for COVID-19 prophylaxis.     No Medical History information was reported.    On 28-Dec-2021, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) .25 milliliter. On 28-Dec-2021, the patient experienced EXPIRED DEVICE USED (Vaccine that administered beyond use date after the thaw process/expired vaccine administered). At the time of the report, EXPIRED DEVICE USED (Vaccine that administered beyond use date after the thaw process/expired vaccine administered) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   Patient age was reported as 63 years and 9 months. No concomitant medication information was provided. On 10-Jun-2022, medical was notified about an audit that was done and they were then made aware of vaccines that were administered beyond use date after the thaw process.  Patient received third dose of vaccine. Moderna vaccine Ndc code reported. Reporter stated that there was no patient that had any adverse reactions and there were no reports of any reactions after the administration of vaccines.   No treatment medication information was provided.
Age: 36.0
Sex: F
Vaccine: COVID19
Symptoms: Expired product administered
Clinical narrative: Vaccine administered beyond use date after the thaw process; This spontaneous case was reported by a paramedic and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Vaccine administered beyond use date after the thaw process) in a 37-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 027H21B) for COVID-19 prophylaxis.     No Medical History information was reported.    On 28-Dec-2021, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) .25 milliliter. On 28-Dec-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (Vaccine administered beyond use date after the thaw process). At the time of the report, EXPIRED PRODUCT ADMINISTERED (Vaccine administered beyond use date after the thaw process) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   The patient's age was reported as 37 years and 2 months. No concomitant medication was provided. It was reported that vaccine was administered beyond use date to the patients. There was no adverse reaction noted or reported regarding these administrations. Vaccine NDC code. No treatment medication was provided.
Age: 61.0
Sex: M
Vaccine: COVID19
Symptoms: Expired product administered
Clinical narrative: Vaccines that were administered beyond use date after thaw process; This spontaneous case was reported by a paramedic and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Vaccines that were administered beyond use date after thaw process) in a 62-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 027H21B) for COVID-19 prophylaxis.     No Medical History information was reported.    On 28-Dec-2021, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) .25 milliliter. On 28-Dec-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (Vaccines that were administered beyond use date after thaw process). At the time of the report, EXPIRED PRODUCT ADMINISTERED (Vaccines that were administered beyond use date after thaw process) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   Patient's age was reported as 62 years and 5 months.  No concomitant medication information was provided.  On 10-Jun-2022, medical was notified about an audit that was done and they were then made aware of vaccines that were administered beyond use date after the thaw process. Reporter stated that there was no patient that had any adverse reactions and there were no reports of any reactions after the administration of vaccines.   Moderna vaccine Ndc code was reported.  No treatment medication information was provided.
Age: 69.0
Sex: M
Vaccine: COVID19
Symptoms: Expired product administered
Clinical narrative: Patient was administered with vaccine that was beyond use date after the thaw process; This spontaneous case was reported by a paramedic and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Patient was administered with vaccine that was beyond use date after the thaw process) in a 69-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 027H21B) for COVID-19 prophylaxis. It was unknown if patient had acute illness at the time of vaccination and up to one month before.  On 26-Dec-2021, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) .25 milliliter. On 26-Dec-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (Patient was administered with vaccine that was beyond use date after the thaw process). At the time of the report, EXPIRED PRODUCT ADMINISTERED (Patient was administered with vaccine that was beyond use date after the thaw process) outcome was unknown. For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments. It was reported that the age of patient was 69 years 08 months. No concomitant medications were reported It was unknown if patient had been diagnosed with or tested positive for COVID-19, nor if patient had chronic or long lasting health conditions. Patient had reported no adverse reactions after the administration of vaccine. No treatment medication were reported. On 10-Jun-2022, the vaccination facility was made aware of administration of vaccines beyond use date after the thaw process while audit was conducted. Patient got Moderna with vaccine Ndc code.
Age: 30.0
Sex: M
Vaccine: COVID19
Symptoms: Expired product administered
Clinical narrative: Vaccine that administered beyond use date after the thaw process/expired vaccine administered; This spontaneous case was reported by a paramedic and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Vaccine that administered beyond use date after the thaw process/expired vaccine administered) in a 31-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 027H21B) for COVID-19 prophylaxis.     It was unknown if patient had acute illness at the time of vaccination and up to one month before. It was unknown if patient had been diagnosed with or tested positive for COVID-19.     On 29-Dec-2021, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) .25 milliliter. On 29-Dec-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (Vaccine that administered beyond use date after the thaw process/expired vaccine administered). At the time of the report, EXPIRED PRODUCT ADMINISTERED (Vaccine that administered beyond use date after the thaw process/expired vaccine administered) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   Concomitant medications were not reported.  Vaccine were administered beyond use date after the thaw process to the patients. There was no patient that had any adverse reactions and no reports of any reactions after the administration of the vaccines.  Treatment medications were not reported.
Age: 27.0
Sex: M
Vaccine: COVID19
Symptoms: Expired product administered
Clinical narrative: Patient was administered with vaccine that was beyond use date after the thaw process; This spontaneous case was reported by a paramedic and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Patient was administered with vaccine that was beyond use date after the thaw process) in a 27-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 027H21B) for COVID-19 prophylaxis.     No Medical History information was reported.    On 27-Dec-2021, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) .25 milliliter. On 27-Dec-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (Patient was administered with vaccine that was beyond use date after the thaw process). At the time of the report, EXPIRED PRODUCT ADMINISTERED (Patient was administered with vaccine that was beyond use date after the thaw process) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   It was reported that the age of patient was 27 years 6  months. No concomitant medications were reported It was unknown if patient had acute illness at the time of vaccination and up to one month before. It was unknown if patient had been diagnosed with or tested positive for COVID-19, nor if patient had chronic or long lasting health conditions. Patient had reported no adverse reactions after the administration of vaccine. Treatment details was not reported by the reporter. It was reported that the vaccine 1 Ndc Code.
Age: 27.0
Sex: F
Vaccine: COVID19
Symptoms: Expired product administered
Clinical narrative: Patient was administered with vaccine that was beyond use date after the thaw process; This spontaneous case was reported by a paramedic and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Patient was administered with vaccine that was beyond use date after the thaw process) in a 27-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 027H21B) for COVID-19 prophylaxis.     It was unknown if patient had acute illness at the time of vaccination and up to one month before. It was unknown if patient had been diagnosed with or tested positive for COVID-19, nor if patient had chronic or long lasting health conditions.     On 28-Dec-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) .5 milliliter. On 28-Dec-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (Patient was administered with vaccine that was beyond use date after the thaw process). At the time of the report, EXPIRED PRODUCT ADMINISTERED (Patient was administered with vaccine that was beyond use date after the thaw process) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   It was reported that the age of patient was 27 years 8 months. No concomitant medications were reported.  On 10-Jun-2022, the vaccination facility was made aware of administration of vaccines beyond use date after the thaw process while audit was conducted. Patient got Moderna with vaccine Ndc code.  Patient had no adverse reactions after the administration of vaccine. No treatment medication was reported.
Age: 41.0
Sex: M
Vaccine: COVID19
Symptoms: Expired product administered
Clinical narrative: Vaccines that were administered beyond use date after thaw process; This spontaneous case was reported by a paramedic and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Vaccines that were administered beyond use date after thaw process) in a 42-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 027H21B) for COVID-19 prophylaxis.     No Medical History information was reported.    On 27-Dec-2021, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) .25 milliliter. On 27-Dec-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (Vaccines that were administered beyond use date after thaw process). At the time of the report, EXPIRED PRODUCT ADMINISTERED (Vaccines that were administered beyond use date after thaw process) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   The patient's age was reported as 42  years and 05 months. No concomitant medication was provided. It was reported that vaccine was administered beyond use date to the patients. There was no adverse reaction noted or reported regarding these administrations. Vaccine NDC code. No treatment medication was provided.
Age: 46.0
Sex: M
Vaccine: COVID19
Symptoms: Expired product administered
Clinical narrative: Vaccine that administered beyond use date after the thaw process/expired vaccine administered; This spontaneous case was reported by a paramedic and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Vaccine that administered beyond use date after the thaw process/expired vaccine administered) in a 46-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 029H21B) for COVID-19 prophylaxis.     No Medical History information was reported.    On 18-Jan-2022, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) .25 milliliter. On 18-Jan-2022, the patient experienced EXPIRED PRODUCT ADMINISTERED (Vaccine that administered beyond use date after the thaw process/expired vaccine administered). At the time of the report, EXPIRED PRODUCT ADMINISTERED (Vaccine that administered beyond use date after the thaw process/expired vaccine administered) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   Patient age was reported as 46 years 7 months.  No concomitant medication information was provided. On 10-Jun-2022, medical was notified about an audit that was done and they were then made aware of vaccines that were administered beyond use date after the thaw process. Patient got Moderna with vaccine Ndc code. Reporter stated that there was no patient that had any adverse reactions and there were no reports of any reactions after the administration of vaccines. No treatment medication were provided.
Age: 20.0
Sex: F
Vaccine: COVID19
Symptoms: Expired product administered
Clinical narrative: Vaccine that administered beyond use date after the thaw process/expired vaccine administered; This spontaneous case was reported by a paramedic and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Vaccine that administered beyond use date after the thaw process/expired vaccine administered) in a 20-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 027H21B) for COVID-19 prophylaxis.     No Medical History information was reported.    On 27-Dec-2021, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) .25 milliliter. On 27-Dec-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (Vaccine that administered beyond use date after the thaw process/expired vaccine administered). At the time of the report, EXPIRED PRODUCT ADMINISTERED (Vaccine that administered beyond use date after the thaw process/expired vaccine administered) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   Patient's age was reported as 20 years and 6 months old. No concomitant medication information was provided. No treatment medication were provided.  On 10-Jun-2022, medical was notified about an audit that was done and they were then made aware of vaccines that were administered beyond use date after the thaw process. Reporter stated that there were no patient that had any adverse reactions and there were no reports of any reactions after the administration of vaccines. Patient got Moderna with vaccine Ndc code.
Age: 32.0
Sex: F
Vaccine: COVID19
Symptoms: Expired product administered
Clinical narrative: Vaccine that administered beyond use date after the thaw process/expired vaccine administered; This spontaneous case was reported by a paramedic and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Vaccine that administered beyond use date after the thaw process/expired vaccine administered) in a 32-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 027H21B) for COVID-19 prophylaxis.     No Medical History information was reported.    On 27-Dec-2021, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) .25 milliliter. On 27-Dec-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (Vaccine that administered beyond use date after the thaw process/expired vaccine administered). At the time of the report, EXPIRED PRODUCT ADMINISTERED (Vaccine that administered beyond use date after the thaw process/expired vaccine administered) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   No concomitant medication information was provided. On 10-Jun-2022, medical was notified about an audit that was done and they were then made aware of vaccines that were administered beyond use date after the thaw process. Patient got Moderna with vaccine Ndc code. Reporter stated that there was no patient that had any adverse reactions and there were no reports of any reactions after the administration of vaccines. No treatment medication were provided.