chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 80.0
Sex: F
Vaccine: VARZOS
Symptoms: Amnesia, Blood test, Culture urine negative, Erythema, Peripheral swelling
Clinical narrative: Short-term memory loss; Swelling on left arm (size of a grapefruit); Redness on left arm (size of a grapefruit); This case was reported by a consumer via call center representative and described the occurrence of short-term memory loss in a 80-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   On 14th February 2023, the patient received the 1st dose of Shingrix. In February 2023, unknown after receiving Shingrix, the patient experienced swelling arm and erythema of extremities. On 18th February 2023, the patient experienced short-term memory loss. On an unknown date, the outcome of the short-term memory loss was unknown and the outcome of the swelling arm and erythema of extremities were recovered/resolved.   It was unknown if the reporter considered the short-term memory loss, swelling arm and erythema of extremities to be related to Shingrix.  Additional Information: GSK Receipt Date: 21-FEB-2023 Reporter's comments: The reporter was the patient's brother in law.  The patient received her first dose of Shingrix in left arm. She had experienced swelling and redness on her left arm that grew to the size of a golf ball and then the size of a grapefruit. The swelling and redness had resolved. On 18 February 2023, the patient had experienced sudden short-term memory loss. She went to the Emergency Room (ER) on 18 February 2023, where bloodwork and culture was done. Urinary Tract Infection (UTI) was suspected but the culture was negative. The reporter was unknown for what had caused the short term memory loss. The reporter did not consented to follow-up. Additional supportive information: 4 days after receiving Shingrix, the patient experienced short-term memory loss.
Sex: U
Vaccine: VARZOS
Symptoms: Incomplete course of vaccination
Clinical narrative: not received the 2nd dose; This case was reported by a pharmacist via call center representative and described the occurrence of incomplete course of vaccination in an unspecified number of patients who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included shingrix (received 1st dose on an unknown date).   On an unknown date, the patient did not receive the 2nd dose of Shingrix. On an unknown date, unknown after receiving Shingrix, the patient experienced incomplete course of vaccination. On an unknown date, the outcome of the incomplete course of vaccination was unknown.   Additional Information: GSK Receipt Date: 22-Feb-2023 Reporter's Comments:  Pharmacist states that she had a few patients (at least 10) who have had their first dose of Shingrix but have not received the 2nd.  She stated that they might had received the 2nd dose elsewhere but she was not certain. The reporter consented to follow up via postal. HCP did not have any patient demographics currently but states that they were all over 65 years of age.  Additional Supportive Information: Till the time of reporting, the patient did not receive 2nd dose of Shingrix, which led to incomplete course of vaccination.
Age: 1.0
Sex: F
Vaccine: HEPA
Symptoms: Expired product administered
Clinical narrative: Expired Havrix administered; This case was reported by a other health professional via call center representative and described the occurrence of expired vaccine used in a 18-month-old female patient who received HAV (Havrix) (batch number YG7YJ, expiry date 3rd February 2023) for prophylaxis.   On 21st February 2023, the patient received Havrix. On 21st February 2023, unknown after receiving Havrix, the patient experienced expired vaccine used. On an unknown date, the outcome of the expired vaccine used was unknown.   Additional Information: GSK Receipt Date: 22-FEB-2023 Reporter's Comment: The reporter was medical assistant. The reporter stated that patient was given expired dose of Havrix the day before reporting. No further details were provided.  The reporter's permission granted for safety follow up. Additional Supportive Information: The reporter stated that patient was given expired dose of Havrix the day before reporting, which led to expired vaccine used. The case had been linked to US2023029950, reported by the same reporter, for a different patient.; Sender's Comments:  US-GSK-US2023029950:Same reporter
Age: 1.0
Sex: F
Vaccine: HEPA
Symptoms: Expired product administered
Clinical narrative: Expired Havrix administered; This case was reported by a other health professional via call center representative and described the occurrence of expired vaccine used in a 13-month-old female patient who received HAV (Havrix) (batch number YG7YJ, expiry date 3rd February 2023) for prophylaxis.   On 21st February 2023, the patient received Havrix. On 21st February 2023, unknown after receiving Havrix, the patient experienced expired vaccine used. On an unknown date, the outcome of the expired vaccine used was unknown.   Additional Information: GSK receipt date: 22-Feb-2023 The medical assistant stated that the two patients were given expired doses of Havrix on day before reporting.  The reporter consented to follow up. There were no further details provided.  This case had been linked with US2023029952 same reporter. Additional supportive information: The patient was administered an expired dose of Havrix, which led to expired vaccine used.; Sender's Comments:  US-GSK-US2023029952:Same reporter
Age: 3.0
Sex: M
Vaccine: HEPA
Symptoms: Expired product administered
Clinical narrative: Expired Harix administered; This case was reported by a nurse via call center representative and described the occurrence of expired vaccine used in a 3-year-old male patient who received HAV (Havrix 720) (batch number LY35X, expiry date 16th February 2023) for prophylaxis.   Co-suspect products included hepatitis A vaccine pre-filled syringe device (Havrix Pre-Filled Syringe Device) injection syringe for prophylaxis.   On 22nd February 2023, the patient received Havrix 720 and Havrix Pre-Filled Syringe Device. On 22nd February 2023, unknown after receiving Havrix 720 and Havrix Pre-Filled Syringe Device, the patient experienced expired vaccine used. On an unknown date, the outcome of the expired vaccine used was unknown.   This report is made by GSK without prejudice and does not imply any admission or liability for the incident or its consequences.   Additional Information: GSK receipt date: 22-FEB-2023 Reporter's comment: The reporter reported that the patient received an expired dose of Havrix pediatric dose on the day of reporting. Havrix presentation (pfs- Pre-Filled Syringe) confirmed by batch number look up. The reporter was consented to follow up. Additional supportive information: The patient received expired dose of Havrix pediatric, which led to expired vaccine used.
Sex: F
Vaccine: VARZOS
Symptoms: Incomplete course of vaccination
Clinical narrative: 1st dose over a year ago; This case was reported by a consumer via call center representative and described the occurrence of incomplete course of vaccination in a 67-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included Shingrix (received 1st dose (0.5 ml) on unknown deltoid via intramuscular route over a year ago from reporting).   On an unknown date, the patient did not receive the 2nd dose of Shingrix. On an unknown date, unknown after receiving Shingrix, the patient experienced incomplete course of vaccination. On an unknown date, the outcome of the incomplete course of vaccination was unknown.   Additional Information: GSK Receipt date: 23-Feb-2023. Reporter's Comment: Caller is the husband of the patient. Patient received 1st dose of Shingrix on unknown date or arm. The reporter did not consent to follow up.
Sex: U
Vaccine: COVID19
Symptoms: Blood pressure measurement, Head banging, Hypertension
Clinical narrative: BLOOD PRESSURE SO HIGH; HEAD BANGING SO HARD; This spontaneous report received from a patient via a company representative concerned a 60 year old of unspecified sex. The patient's weight, height, and medical history were not reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin, and batch number were not reported) dose, start therapy date were not reported for covid-19 prophylaxis. The batch number was not reported and has been requested. No concomitant medications were reported. On an unspecified date, the patient experienced blood pressure so high, and head banging so hard. Laboratory data (dates unspecified) included: Blood pressure so high. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from blood pressure so high, and head banging so hard. This report was non-serious.; Sender's Comments: V0: V0-Medical assessment comment not required as per standard procedure as the case was assessed as non-serious.
Sex: U
Vaccine: COVID19
Symptoms: Arterial occlusive disease, Peripheral ischaemia, Thrombosis with thrombocytopenia syndrome
Clinical narrative: VACCINE-INDUCED THROMBOTIC THROMBOCYTOPENIA; ACUTE LIMB ISCHEMIA; VACCINE-ASSOCIATED ARTERIAL OCCLUSIONS; This spontaneous report was received from literature. This report concerned a patient of an unspecified age, sex, race and ethnicity. The objective of this study was to describe acute limb ischemia secondary to vaccine-induced thrombotic thrombocytopenia. The patient's weight, height, and medical history were not reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin, and batch number were not reported, expiry: unknown) dose, start therapy date were not reported, 1 total administered for covid-19 prophylaxis. The batch number was not reported. Per procedure, no follow-up will be requested for this case. No concomitant medications were reported.  On an unspecified date, the patient experienced vaccine-induced thrombotic thrombocytopenia, and acute limb ischemia with vaccine-associated arterial occlusions. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the vaccine-induced thrombotic thrombocytopenia, acute limb ischemia and vaccine-associated arterial occlusions was not reported. The authors emphasized on acute limb ischemia secondary to vaccine-induced thrombotic thrombocytopenia. Vaccine-associated thrombosis had previously been described in patients presenting with cerebral sinus thrombosis, deep venous thrombosis/ pulmonary embolism, or mesenteric venous thrombosis. Only recently had arterial thrombosis gained attention. A new entity known as vaccine-induced thrombotic thrombocytopenia (VITT) had been associated with the coronavirus disease of 2019 (COVID-19) vaccines produced by AstraZeneca and Johnson and Johnson.  This report was serious (Other Medically Important Condition). This case, from the same reporter is linked to 20230247328.; Sender's Comments: V0: 20230255013 -vaccine-induced thrombotic thrombocytopenia. The event has an unknown/unclear temporal relationship, and is labeled. There is no information on any other factors potentially associated with the event. Therefore, this event is considered consistent with vaccine administration.
Sex: F
Vaccine: COVID19
Symptoms: Chest pain, Dysphagia, Dyspnoea, Muscle tightness, Muscular weakness
Clinical narrative: CAN'T BREATHE; FELT LIKE NECK WAS TIGHT AS SOMEONE WAS STRANGLING; CHEST HURTS ON THE LEFT HAND SIDE; WEAKENED LEFT LEG; FEVER; DIFFICULTY SWALLOWING; COLD; This spontaneous report received from a patient concerned a female of unspecified age. The patient's weight, height, and medical history were not reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 2O7A21A expiry: UNKNOWN) dose was not reported, administered on 06-JUN-2021 for covid-19 prophylaxis. No concomitant medications were reported. On 2021, the patient experienced cold, difficulty swallowing, and fever. On an unspecified date, the patient experienced can't breathe, felt like neck was tight as someone was strangling, chest hurts on the left hand side, and weakened left leg. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from difficulty swallowing, and the outcome of cold, can't breathe, weakened left leg, felt like neck was tight as someone was strangling, chest hurts on the left hand side and fever was not reported. This report was non-serious.
Sex: F
Vaccine: COVID19
Symptoms: Nasopharyngitis, Pyrexia
Clinical narrative: CAN'T BREATHE; FELT LIKE NECK WAS TIGHT AS SOMEONE WAS STRANGLING; CHEST HURTS ON THE LEFT HAND SIDE; WEAKENED LEFT LEG; FEVER; DIFFICULTY SWALLOWING; COLD; This spontaneous report received from a patient concerned a female of unspecified age. The patient's weight, height, and medical history were not reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 2O7A21A expiry: UNKNOWN) dose was not reported, administered on 06-JUN-2021 for covid-19 prophylaxis. No concomitant medications were reported. On 2021, the patient experienced cold, difficulty swallowing, and fever. On an unspecified date, the patient experienced can't breathe, felt like neck was tight as someone was strangling, chest hurts on the left hand side, and weakened left leg. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from difficulty swallowing, and the outcome of cold, can't breathe, weakened left leg, felt like neck was tight as someone was strangling, chest hurts on the left hand side and fever was not reported. This report was non-serious.
Sex: F
Vaccine: COVID19
Symptoms: Bronchitis, Chest X-ray, Sleep disorder
Clinical narrative: bronchitis; wet cough that would wake her up out of a sound sleep; This spontaneous case was reported by a non-health professional and describes the occurrence of BRONCHITIS (bronchitis) and SLEEP DISORDER (wet cough that would wake her up out of a sound sleep) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 prophylaxis.     Historical condition also included removal of pain pump. Patient was also allergic to green and red peppers.  The patient's past medical history included Accident automobile, Rape victim, Claustrophobia, Cervical cancer, Lung nodule (Left Lung Node), Spinal cord injury thoracic (compound fracture of T-12), Hip discomfort, Red man syndrome, Hysterectomy, Back surgery (2 failed back surgeries) and Spinal fusion. Concurrent medical conditions included Hypothyroidism (Thyroid disease), Muscle spasms, Blood pressure high, Tiredness (Tiredness form Steroids and Benadryl), Leg pain, Weakness of limbs, Herniated disc (Herniations and disc bulging from Thoracic 11 to Sacral 1 discs), Multiple sclerosis exacerbation, Latex allergy, Drug allergy (Allergy to codeine, tylenol 3, Imitrex pills, Prozac, fentanyl, tramadol, methadone, toradol, NSAIDS, Depakote, tegretol, cymbalta and morphine IV.), Adhesive tape allergy, Allergy to topical drugs, Chronic pain, Vision abnormal, Migraine, Chronic cough, Depression, Anxiety and Sacroiliitis. Concomitant products included DIAZEPAM (VALIUM), LEVOTHYROXINE SODIUM (SYNTHROID), HYDROCHLOROTHIAZIDE, LISINOPRIL (LISINOPRIL + HIDROCLOROTIAZIDA), OCRELIZUMAB (OCREVUS), DIPHENHYDRAMINE HYDROCHLORIDE (BENADRYL [DIPHENHYDRAMINE HYDROCHLORIDE]), OXYCODONE, GABAPENTIN, AMITRIPTYLINE, OXYCODONE (XTAMPZA ER) and SUMATRIPTAN (IMITREX [SUMATRIPTAN]) for an unknown indication.   On an unknown date, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient experienced BRONCHITIS (bronchitis) and SLEEP DISORDER (wet cough that would wake her up out of a sound sleep). The patient was treated with BENZONATATE (TESSALON PERLE) at an unspecified dose and frequency. At the time of the report, BRONCHITIS (bronchitis) and SLEEP DISORDER (wet cough that would wake her up out of a sound sleep) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, Chest X-ray: no pneumonia but they gave her tesselon perles..         It was reported that patient started therapy with Moderna Shot and developed a bronchitis wet cough that would wake her up out of a sound sleep because the phlegm was stuck and she stopped breathing.
Age: 72.0
Sex: M
Vaccine: COVID19
Symptoms: Inappropriate schedule of product administration, No adverse event
Clinical narrative: No adverse event; Moderna Dose 1 on 31-JAN-2021, Moderna Dose 2 on 8-MAR-2021; This spontaneous case was reported by a patient and describes the occurrence of INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Moderna Dose 1 on 31-JAN-2021, Moderna Dose 2 on 8-MAR-2021) and NO ADVERSE EVENT (No adverse event) in a 74-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 040A21A and 004M20A) for COVID-19 prophylaxis.     Concomitant products included MULTIVITAMINS [VITAMINS NOS], CURCUMIN (THERACURMIN BIOACTIVE), UBIDECARENONE (COQ10 [UBIDECARENONE]), PYCNOGENOL and SAW PALMETTO [SERENOA REPENS] for an unknown indication.   On 31-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 08-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 08-Mar-2021, the patient experienced INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Moderna Dose 1 on 31-JAN-2021, Moderna Dose 2 on 8-MAR-2021). On an unknown date, the patient experienced NO ADVERSE EVENT (No adverse event). At the time of the report, INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Moderna Dose 1 on 31-JAN-2021, Moderna Dose 2 on 8-MAR-2021) and NO ADVERSE EVENT (No adverse event) outcome was unknown.            It was reported that patient took moderna dose three on 10-Nov-2021 batch number 066F21A, at left arm. Fourth dose on 16-May-2022 batch number 056M21A at left arm. Fifth dose on 25-Oct-2022 unknown batch number at left arm. Patient also experienced Paxlovid COVID rebound. First time getting COVID. Tested on 13-Feb-2023. Began Paxlovid on 13-Feb-2023 in pm with batch number GF3904. Ended 5 day treatment Feb 18th am. Tested negative on 21-Feb. Symptoms cleared. Retested on 23-Feb as precaution. No rebound symptoms. Tested positive again. Later in day, after positive test, began recurring/rebound symptoms of bad head cold.  Treatment medications were not reported.
Age: 68.0
Sex: M
Vaccine: COVID19-2, COVID19
Symptoms: Appendicitis, Bronchitis
Clinical narrative: COVID-19 in Dec-2021; This spontaneous case was reported by a patient and describes the occurrence of COVID-19 (COVID-19 in Dec-2021) in a 68-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 013F21A, 001A21A, 006B21A and 046L21A) for COVID-19 prophylaxis.     It was reported that patient had received other vaccines in the 4 weeks prior to COVID-19 vaccine. It was reported that patient had no allergies.  The patient's past medical history included Accidental injury (injured in a work accident in the summer of 1980) in 1980. Previously administered products included for Product used for unknown indication: DIPHTHERIA VACCINE (5 year old got diphtheria vaccine), MEASLES VACCINE (5 year old got measles), INFLUENZA VACCINE, SMALLPOX VACCINE (5 year old got small pox) and MUMPS VACCINE (5 year old got mumps). Past adverse reactions to the above products included No adverse event with DIPHTHERIA VACCINE, INFLUENZA VACCINE, MEASLES VACCINE, MUMPS VACCINE and SMALLPOX VACCINE. Concurrent medical conditions included Migraine (due to infected root canal).   On 04-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 01-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 21-Nov-2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 31-Mar-2022, received fourth dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. In December 2021, the patient experienced COVID-19 (COVID-19 in Dec-2021). At the time of the report, COVID-19 (COVID-19 in Dec-2021) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): In December 2021, SARS-CoV-2 test: Positive.     For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   Concomitant drugs were not reported. Treatment medications were not provided.   This case was linked to MOD-2023-712511 (Patient Link).
Age: 68.0
Sex: M
Vaccine: COVID19-2, COVID19
Symptoms: COVID-19, SARS-CoV-2 test positive
Clinical narrative: COVID-19 in Dec-2021; This spontaneous case was reported by a patient and describes the occurrence of COVID-19 (COVID-19 in Dec-2021) in a 68-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 013F21A, 001A21A, 006B21A and 046L21A) for COVID-19 prophylaxis.     It was reported that patient had received other vaccines in the 4 weeks prior to COVID-19 vaccine. It was reported that patient had no allergies.  The patient's past medical history included Accidental injury (injured in a work accident in the summer of 1980) in 1980. Previously administered products included for Product used for unknown indication: DIPHTHERIA VACCINE (5 year old got diphtheria vaccine), MEASLES VACCINE (5 year old got measles), INFLUENZA VACCINE, SMALLPOX VACCINE (5 year old got small pox) and MUMPS VACCINE (5 year old got mumps). Past adverse reactions to the above products included No adverse event with DIPHTHERIA VACCINE, INFLUENZA VACCINE, MEASLES VACCINE, MUMPS VACCINE and SMALLPOX VACCINE. Concurrent medical conditions included Migraine (due to infected root canal).   On 04-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 01-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 21-Nov-2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 31-Mar-2022, received fourth dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. In December 2021, the patient experienced COVID-19 (COVID-19 in Dec-2021). At the time of the report, COVID-19 (COVID-19 in Dec-2021) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): In December 2021, SARS-CoV-2 test: Positive.     For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   Concomitant drugs were not reported. Treatment medications were not provided.   This case was linked to MOD-2023-712511 (Patient Link).
Age: 91.0
Sex: F
Vaccine: COVID19-2
Symptoms: Expired product administered, No adverse event, Product storage error
Clinical narrative: The vial was initially stored in the refrigerator on 29-Dec-2022 and was administered on 10-Feb-2023; No adverse event; Dose 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 (Dose administered after 30-day Use By Date), PRODUCT STORAGE ERROR (The vial was initially stored in the refrigerator on 29-Dec-2022 and was administered on 10-Feb-2023) and NO ADVERSE EVENT (No adverse event) in a 91-year-old female patient who received mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (batch no. AS7172B) for COVID-19 prophylaxis.   No Medical History information was reported.    On 10-Feb-2023, the patient received dose of mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (unknown route) 1 dosage form. On 10-Feb-2023, after starting mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)), the patient experienced EXPIRED PRODUCT ADMINISTERED (Dose administered after 30-day Use By Date). On an unknown date, the patient experienced PRODUCT STORAGE ERROR (The vial was initially stored in the refrigerator on 29-Dec-2022 and was administered on 10-Feb-2023) and NO ADVERSE EVENT (No adverse event). At the time of the report, EXPIRED PRODUCT ADMINISTERED (Dose administered after 30-day Use By Date), PRODUCT STORAGE ERROR (The vial was initially stored in the refrigerator on 29-Dec-2022 and was administered on 10-Feb-2023) and NO ADVERSE EVENT (No adverse event) outcome was unknown.     For mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (Unknown), the reporter considered NO ADVERSE EVENT (No adverse event) to be not related. No further causality assessments were provided for EXPIRED PRODUCT ADMINISTERED (Dose administered after 30-day Use By Date) and PRODUCT STORAGE ERROR (The vial was initially stored in the refrigerator on 29-Dec-2022 and was administered on 10-Feb-2023).    No concomitant medications were reported.  The vial was initially stored in the refrigerator on 29-Dec-2022. 2 patients received vaccine on 31-Jan-2023, 2 patients received vaccine on 02-Feb-2023 and 3 patients received vaccine on 10-Feb-2023. The vial did not undergo any temperature excursions.Was reported as 28-Jan-2023.  No treatment information was provided.   This case was linked to US-MODERNATX, INC.-MOD-2023-712785, US-MODERNATX, INC.-MOD-2023-712776, US-MODERNATX, INC.-MOD-2023-712783, US-MODERNATX, INC.-MOD-2023-712773, US-MODERNATX, INC.-MOD-2023-712771, US-MODERNATX, INC.-MOD-2023-712812 (E2B Linked Report).; Sender's Comments:  US-MODERNATX, INC.-MOD-2023-712771:Same reporter US-MODERNATX, INC.-MOD-2023-712783:Same reporter US-MODERNATX, INC.-MOD-2023-712773:Same reporter US-MODERNATX, INC.-MOD-2023-712785:Same reporter US-MODERNATX, INC.-MOD-2023-712776:Same reporter US-MODERNATX, INC.-MOD-2023-712812:Same reporter
Age: 67.0
Sex: M
Vaccine: COVID19-2, COVID19
Symptoms: Circumstance or information capable of leading to medication error, No adverse event
Clinical narrative: No Adverse Event; AE submitted after call due to uncertainty of whether or not the last dose received was a monovalent booster or Bivalent.; This spontaneous case was reported by a patient and describes the occurrence of CIRCUMSTANCE OR INFORMATION CAPABLE OF LEADING TO MEDICATION ERROR (AE submitted after call due to uncertainty of whether or not the last dose received was a monovalent booster or Bivalent.) and NO ADVERSE EVENT (No Adverse Event) in a 67-year-old male patient who received mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (batch no. 062F22A) for COVID-19 prophylaxis.   Previously administered products included for COVID-19 prophylaxis: Moderna COVID-19 Vaccine (First dose) on 14-Jan-2021, Moderna COVID-19 Vaccine (Second dose) on 13-Feb-2021, Moderna COVID-19 Vaccine (First booster) on 14-Nov-2021 and Moderna COVID-19 Vaccine (second booster) on 15-Mar-2022. Past adverse reactions to the above products included No adverse event with Moderna COVID-19 Vaccine, Moderna COVID-19 Vaccine, Moderna COVID-19 Vaccine and Moderna COVID-19 Vaccine. Family history included Cancer (Patient wife was diagnosed with cancer before 2021 Moderna Covid vaccinations) since an unknown date.    On 15-Oct-2022, the patient received fifth dose of mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (unknown route) 1 dosage form. On 15-Oct-2022, after starting mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)), the patient experienced CIRCUMSTANCE OR INFORMATION CAPABLE OF LEADING TO MEDICATION ERROR (AE submitted after call due to uncertainty of whether or not the last dose received was a monovalent booster or Bivalent.). On an unknown date, the patient experienced NO ADVERSE EVENT (No Adverse Event). At the time of the report, CIRCUMSTANCE OR INFORMATION CAPABLE OF LEADING TO MEDICATION ERROR (AE submitted after call due to uncertainty of whether or not the last dose received was a monovalent booster or Bivalent.) and NO ADVERSE EVENT (No Adverse Event) outcome was unknown.      For mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (Unknown), the reporter considered NO ADVERSE EVENT (No Adverse Event) to be not related. No further causality assessment was provided for CIRCUMSTANCE OR INFORMATION CAPABLE OF LEADING TO MEDICATION ERROR (AE submitted after call due to uncertainty of whether or not the last dose received was a monovalent booster or Bivalent.).    No concomitant medications were reported.  Patient had kept their boosters up with Moderna all the way and never had a problem or got COVID.  No treatment information was provided.   This case was linked to US-MODERNATX, INC.-MOD-2023-712892 (E2B Linked Report).; Sender's Comments:  US-MODERNATX, INC.-MOD-2023-712892:Wife case
Age: 67.0
Sex: M
Vaccine: COVID19-2, COVID19
Symptoms: No adverse event, Product dose omission issue
Clinical narrative: No Adverse Event; AE submitted after call due to uncertainty of whether or not the last dose received was a monovalent booster or Bivalent.; This spontaneous case was reported by a patient and describes the occurrence of CIRCUMSTANCE OR INFORMATION CAPABLE OF LEADING TO MEDICATION ERROR (AE submitted after call due to uncertainty of whether or not the last dose received was a monovalent booster or Bivalent.) and NO ADVERSE EVENT (No Adverse Event) in a 67-year-old male patient who received mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (batch no. 062F22A) for COVID-19 prophylaxis.   Previously administered products included for COVID-19 prophylaxis: Moderna COVID-19 Vaccine (First dose) on 14-Jan-2021, Moderna COVID-19 Vaccine (Second dose) on 13-Feb-2021, Moderna COVID-19 Vaccine (First booster) on 14-Nov-2021 and Moderna COVID-19 Vaccine (second booster) on 15-Mar-2022. Past adverse reactions to the above products included No adverse event with Moderna COVID-19 Vaccine, Moderna COVID-19 Vaccine, Moderna COVID-19 Vaccine and Moderna COVID-19 Vaccine. Family history included Cancer (Patient wife was diagnosed with cancer before 2021 Moderna Covid vaccinations) since an unknown date.    On 15-Oct-2022, the patient received fifth dose of mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (unknown route) 1 dosage form. On 15-Oct-2022, after starting mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)), the patient experienced CIRCUMSTANCE OR INFORMATION CAPABLE OF LEADING TO MEDICATION ERROR (AE submitted after call due to uncertainty of whether or not the last dose received was a monovalent booster or Bivalent.). On an unknown date, the patient experienced NO ADVERSE EVENT (No Adverse Event). At the time of the report, CIRCUMSTANCE OR INFORMATION CAPABLE OF LEADING TO MEDICATION ERROR (AE submitted after call due to uncertainty of whether or not the last dose received was a monovalent booster or Bivalent.) and NO ADVERSE EVENT (No Adverse Event) outcome was unknown.      For mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (Unknown), the reporter considered NO ADVERSE EVENT (No Adverse Event) to be not related. No further causality assessment was provided for CIRCUMSTANCE OR INFORMATION CAPABLE OF LEADING TO MEDICATION ERROR (AE submitted after call due to uncertainty of whether or not the last dose received was a monovalent booster or Bivalent.).    No concomitant medications were reported.  Patient had kept their boosters up with Moderna all the way and never had a problem or got COVID.  No treatment information was provided.   This case was linked to US-MODERNATX, INC.-MOD-2023-712892 (E2B Linked Report).; Sender's Comments:  US-MODERNATX, INC.-MOD-2023-712892:Wife case
Age: 65.0
Sex: F
Vaccine: COVID19-2, COVID19
Symptoms: Circumstance or information capable of leading to medication error, No adverse event
Clinical narrative: cancer patient, received 1st booster dose on 14Nov2021 instead of 3rd primary dose; No Adverse Event; This spontaneous case was reported by a patient family member or friend and describes the occurrence of PRODUCT DOSE OMISSION ISSUE (cancer patient, received 1st booster dose on 14Nov2021 instead of 3rd primary dose) and NO ADVERSE EVENT (No Adverse Event) in a 65-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 prophylaxis.     Concurrent medical conditions included Cancer (Diagnosed with cancer before 2021 (before Moderna Covid vaccinations)) and Immunocompromised.   On 14-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 13-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 14-Nov-2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 15-Mar-2022, received fourth dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient experienced PRODUCT DOSE OMISSION ISSUE (cancer patient, received 1st booster dose on 14Nov2021 instead of 3rd primary dose) and NO ADVERSE EVENT (No Adverse Event). At the time of the report, PRODUCT DOSE OMISSION ISSUE (cancer patient, received 1st booster dose on 14Nov2021 instead of 3rd primary dose) and NO ADVERSE EVENT (No Adverse Event) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter considered NO ADVERSE EVENT (No Adverse Event) to be not related. No further causality assessment was provided for PRODUCT DOSE OMISSION ISSUE (cancer patient, received 1st booster dose on 14Nov2021 instead of 3rd primary dose).    No concomitant medications were reported. It was reported that patient got a special shot that cancer doctor wrote for patient. A specialized shot for cancer was taken at some point in the middle of 2022. On 15-Oct-2022, patient received Moderna updated booster with lot number 062F22A.  Reporter stated that they had kept their boosters up with Moderna all the way and never had a problem or got covid. Reporter thought they got the Bivalent booster because when they were at the pharmacy they asked for the updated one. No treatment information was provided.   This case was linked to US-MODERNATX, INC.-MOD-2023-712884 (E2B Linked Report).; Sender's Comments:  US-MODERNATX, INC.-MOD-2023-712884:Husband case
Age: 65.0
Sex: F
Vaccine: COVID19-2, COVID19
Symptoms: No adverse event, Product dose omission issue
Clinical narrative: cancer patient, received 1st booster dose on 14Nov2021 instead of 3rd primary dose; No Adverse Event; This spontaneous case was reported by a patient family member or friend and describes the occurrence of PRODUCT DOSE OMISSION ISSUE (cancer patient, received 1st booster dose on 14Nov2021 instead of 3rd primary dose) and NO ADVERSE EVENT (No Adverse Event) in a 65-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 prophylaxis.     Concurrent medical conditions included Cancer (Diagnosed with cancer before 2021 (before Moderna Covid vaccinations)) and Immunocompromised.   On 14-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 13-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 14-Nov-2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 15-Mar-2022, received fourth dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient experienced PRODUCT DOSE OMISSION ISSUE (cancer patient, received 1st booster dose on 14Nov2021 instead of 3rd primary dose) and NO ADVERSE EVENT (No Adverse Event). At the time of the report, PRODUCT DOSE OMISSION ISSUE (cancer patient, received 1st booster dose on 14Nov2021 instead of 3rd primary dose) and NO ADVERSE EVENT (No Adverse Event) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter considered NO ADVERSE EVENT (No Adverse Event) to be not related. No further causality assessment was provided for PRODUCT DOSE OMISSION ISSUE (cancer patient, received 1st booster dose on 14Nov2021 instead of 3rd primary dose).    No concomitant medications were reported. It was reported that patient got a special shot that cancer doctor wrote for patient. A specialized shot for cancer was taken at some point in the middle of 2022. On 15-Oct-2022, patient received Moderna updated booster with lot number 062F22A.  Reporter stated that they had kept their boosters up with Moderna all the way and never had a problem or got covid. Reporter thought they got the Bivalent booster because when they were at the pharmacy they asked for the updated one. No treatment information was provided.   This case was linked to US-MODERNATX, INC.-MOD-2023-712884 (E2B Linked Report).; Sender's Comments:  US-MODERNATX, INC.-MOD-2023-712884:Husband case
Age: 64.0
Sex: M
Vaccine: COVID19-2, COVID19
Symptoms: Inappropriate schedule of product administration, No adverse event
Clinical narrative: No adverse event; The patient received Moderna first dose on 30-Nov-2022, Moderna second dose on 19-Jan-2023, and the bivalent on 23-Feb-2023; This spontaneous case was reported by a pharmacist and describes the occurrence of INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (The patient received Moderna first dose on 30-Nov-2022, Moderna second dose on 19-Jan-2023, and the bivalent on 23-Feb-2023) and NO ADVERSE EVENT (No adverse event) in a 64-year-old male patient who received mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (batch no. 010H22A) for COVID-19 prophylaxis.     It was unknown if patient received any other vaccines in the 4 weeks prior to COVID-19 vaccine.     On 23-Feb-2023, the patient received third dose of mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (unknown route) .5 milliliter. On 23-Feb-2023,  after starting mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)), the patient experienced INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (The patient received Moderna first dose on 30-Nov-2022, Moderna second dose on 19-Jan-2023, and the bivalent on 23-Feb-2023). On an unknown date, the patient experienced NO ADVERSE EVENT (No adverse event). At the time of the report, INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (The patient received Moderna first dose on 30-Nov-2022, Moderna second dose on 19-Jan-2023, and the bivalent on 23-Feb-2023) and NO ADVERSE EVENT (No adverse event) outcome was unknown.        For mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (Unknown), the reporter considered NO ADVERSE EVENT (No adverse event) to be not related. No further causality assessment was provided for INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (The patient received Moderna first dose on 30-Nov-2022, Moderna second dose on 19-Jan-2023, and the bivalent on 23-Feb-2023).    No concomitant information was reported. Suspect product dosage text was reported as initial booster. It was reported that patient did not report any reaction. It was reported that patient received first dose on 30-Nov-2022 and second dose on 19-Jan-2023. No treatment information was provided.   This case was linked to US-MODERNATX, INC.-MOD-2023-713010 (E2B Linked Report).; Sender's Comments:  US-MODERNATX, INC.-MOD-2023-713010:Monovalent dose
Age: 64.0
Sex: M
Vaccine: COVID19-2, COVID19
Symptoms: Inappropriate schedule of product administration, No adverse event
Clinical narrative: No adverse event; The patient received Moderna first dose on 30-Nov-2022, Moderna second dose on 19-Jan-2023; This spontaneous case was reported by a pharmacist and describes the occurrence of INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (The patient received Moderna first dose on 30-Nov-2022, Moderna second dose on 19-Jan-2023) and NO ADVERSE EVENT (No adverse event) in a 64-year-old male patient who received mRNA-1273 (Spikevax) for COVID-19 prophylaxis.     No Medical History information was reported.   On 30-Nov-2022, the patient received first dose of mRNA-1273 (Spikevax) (unknown route) 1 dosage form. On 19-Jan-2023, received second dose of mRNA-1273 (Spikevax) (unknown route) dosage was changed to 1 dosage form. On 19-Jan-2023,  after starting mRNA-1273 (Spikevax), the patient experienced INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (The patient received Moderna first dose on 30-Nov-2022, Moderna second dose on 19-Jan-2023). On an unknown date, the patient experienced NO ADVERSE EVENT (No adverse event). At the time of the report, INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (The patient received Moderna first dose on 30-Nov-2022, Moderna second dose on 19-Jan-2023) and NO ADVERSE EVENT (No adverse event) outcome was unknown.        For mRNA-1273 (Spikevax) (Unknown), the reporter considered NO ADVERSE EVENT (No adverse event) to be not related. No further causality assessment was provided for INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (The patient received Moderna first dose on 30-Nov-2022, Moderna second dose on 19-Jan-2023).    No concomitant medications was reported. It was reported that patient was unknown whether received other vaccines in the 4 weeks prior to COVID-19 vaccine. The pharmacist stated that a patient received the primary and bivalent doses within 5 weeks. The patient did not report any reaction. No treatment drug details was reported.   This case was linked to MOD-2023-713009 (Patient Link).
Age: 53.0
Sex: U
Vaccine: COVID19
Symptoms: Circumstance or information capable of leading to medication error, No adverse event, Transcription medication error
Clinical narrative: a patient who received a dose of the Moderna COVID-19 vaccine from lot number 065K21A/may have documented the incorrect NDC number which does not correspond to this lot number; the assumption is that the 53 year old patient may have been administered the 6-11 year old Moderna product; No adverse event; This spontaneous case was reported by an other health care professional and describes the occurrence of TRANSCRIPTION MEDICATION ERROR (a patient who received a dose of the Moderna COVID-19 vaccine from lot number 065K21A/may have documented the incorrect NDC number which does not correspond to this lot number), CIRCUMSTANCE OR INFORMATION CAPABLE OF LEADING TO MEDICATION ERROR (the assumption is that the 53 year old patient may have been administered the 6-11 year old Moderna product) and NO ADVERSE EVENT (No adverse event) in a 53-year-old patient of an unknown gender who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 065K21A) for COVID-19 prophylaxis.     No Medical History information was reported.    On an unknown date, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced TRANSCRIPTION MEDICATION ERROR (a patient who received a dose of the Moderna COVID-19 vaccine from lot number 065K21A/may have documented the incorrect NDC number which does not correspond to this lot number), CIRCUMSTANCE OR INFORMATION CAPABLE OF LEADING TO MEDICATION ERROR (the assumption is that the 53 year old patient may have been administered the 6-11 year old Moderna product) and NO ADVERSE EVENT (No adverse event). At the time of the report, TRANSCRIPTION MEDICATION ERROR (a patient who received a dose of the Moderna COVID-19 vaccine from lot number 065K21A/may have documented the incorrect NDC number which does not correspond to this lot number), CIRCUMSTANCE OR INFORMATION CAPABLE OF LEADING TO MEDICATION ERROR (the assumption is that the 53 year old patient may have been administered the 6-11 year old Moderna product) and NO ADVERSE EVENT (No adverse event) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter considered NO ADVERSE EVENT (No adverse event) to be not related. No further causality assessments were provided for TRANSCRIPTION MEDICATION ERROR (a patient who received a dose of the Moderna COVID-19 vaccine from lot number 065K21A/may have documented the incorrect NDC number which does not correspond to this lot number) and CIRCUMSTANCE OR INFORMATION CAPABLE OF LEADING TO MEDICATION ERROR (the assumption is that the 53 year old patient may have been administered the 6-11 year old Moderna product).    Concomitant medication was not provided.   Treatment information was not provided.   Reporter did not allow further contact
Age: 10.0
Sex: F
Vaccine: COVID19
Symptoms: Expired product administered, Inappropriate schedule of product administration, No adverse event
Clinical narrative: No report of adverse reaction from patient; inadvertently gave a monovalent vaccine which was beyond the published expiration date; 1st dose was on 10Jan2023, second dose on 27 feb2023; This spontaneous case was reported by an other health care professional and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (inadvertently gave a monovalent vaccine which was beyond the published expiration date), INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (1st dose was on 10Jan2023, second dose on 27 feb2023) and NO ADVERSE EVENT (No report of adverse reaction from patient) in a 10-year-old female patient who received mRNA-1273 (Spikevax) (batch nos. 064A22A and 064A22A) for COVID-19 prophylaxis.     The patient had no relevant medical history/condition, allergy, concomitant diseases and risk factor. The patient had no other vaccines in the 4 weeks prior to COVID-19 vaccine.    On 10-Jan-2023, the patient received first dose of mRNA-1273 (Spikevax) (unknown route) 1 dosage form. On 27-Feb-2023, received second dose of mRNA-1273 (Spikevax) (unknown route) dosage was changed to 1 dosage form. On 27-Feb-2023, the patient experienced EXPIRED PRODUCT ADMINISTERED (inadvertently gave a monovalent vaccine which was beyond the published expiration date) and INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (1st dose was on 10Jan2023, second dose on 27 feb2023). On an unknown date, the patient experienced NO ADVERSE EVENT (No report of adverse reaction from patient). At the time of the report, EXPIRED PRODUCT ADMINISTERED (inadvertently gave a monovalent vaccine which was beyond the published expiration date), INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (1st dose was on 10Jan2023, second dose on 27 feb2023) and NO ADVERSE EVENT (No report of adverse reaction from patient) outcome was unknown.        For mRNA-1273 (Spikevax) (Unknown), the reporter considered NO ADVERSE EVENT (No report of adverse reaction from patient) to be not related. No further causality assessments were provided for EXPIRED PRODUCT ADMINISTERED (inadvertently gave a monovalent vaccine which was beyond the published expiration date) and INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (1st dose was on 10Jan2023, second dose on 27 feb2023).    The concomitant medication was not reported. The treatment medication was not reported. The patient was given monovalent vaccine (6 to 11 years) which was beyond the published expiration date, 24-Feb-2023.