chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 58.0
Sex: F
Vaccine: COVID19
Symptoms: No adverse event, Poor quality product administered, Product temperature excursion issue
Clinical narrative: patients that were vaccinated with this vaccine after the excursion; No adverse event; patients that were vaccinated with this vaccine after the excursion; This spontaneous case was reported by a pharmacist and describes the occurrence of POOR QUALITY PRODUCT ADMINISTERED (patients that were vaccinated with this vaccine after the excursion), PRODUCT TEMPERATURE EXCURSION ISSUE (patients that were vaccinated with this vaccine after the excursion) and NO ADVERSE EVENT (No adverse event) in a 58-year-old female patient who received mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (batch no. AS7162B) for COVID-19 prophylaxis.     Concurrent medical conditions included Hypothyroidism and Penicillin allergy.    On 07-Oct-2022 at 11:17 AM, the patient received dose of mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (Intramuscular) .5 milliliter. On 07-Oct-2022 at 11:17 AM, the patient experienced POOR QUALITY PRODUCT ADMINISTERED (patients that were vaccinated with this vaccine after the excursion). On an unknown date, the patient experienced PRODUCT TEMPERATURE EXCURSION ISSUE (patients that were vaccinated with this vaccine after the excursion) and NO ADVERSE EVENT (No adverse event). At the time of the report, POOR QUALITY PRODUCT ADMINISTERED (patients that were vaccinated with this vaccine after the excursion), PRODUCT TEMPERATURE EXCURSION ISSUE (patients that were vaccinated with this vaccine after the excursion) 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)) (Intramuscular), the reporter considered NO ADVERSE EVENT (No adverse event) to be not related. No further causality assessments were provided for POOR QUALITY PRODUCT ADMINISTERED (patients that were vaccinated with this vaccine after the excursion) and PRODUCT TEMPERATURE EXCURSION ISSUE (patients that were vaccinated with this vaccine after the excursion).    No concomitant medication was reported.  It was unknown if the patient had ever been diagnosed or tested positive for COVID-19.  Acute illness at the time of vaccination and up to one month before was unknown.  It was reported that Moderna bivalent vaccine was administered after a temperature excursion. Patient did not report any adverse events.   No treatment information was provided.
Age: 63.0
Sex: M
Vaccine: COVID19
Symptoms: No adverse event, Poor quality product administered, Product temperature excursion issue
Clinical narrative: patients that were vaccinated with this vaccine after the excursion; No adverse event; patients that were vaccinated with this vaccine after the excursion; This spontaneous case was reported by a pharmacist and describes the occurrence of PRODUCT TEMPERATURE EXCURSION ISSUE (patients that were vaccinated with this vaccine after the excursion), POOR QUALITY PRODUCT ADMINISTERED (patients that were vaccinated with this vaccine after the excursion) and NO ADVERSE EVENT (No adverse event) in a 63-year-old male patient who received mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (batch no. A57162B) for COVID-19 prophylaxis.     Concurrent medical conditions included Diabetes.    On 10-Oct-2022 at 11:25 AM, the patient received first dose of mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (Intramuscular) .5 milliliter. On 10-Oct-2022 at 11:25 AM, the patient experienced POOR QUALITY PRODUCT ADMINISTERED (patients that were vaccinated with this vaccine after the excursion). On an unknown date, the patient experienced PRODUCT TEMPERATURE EXCURSION ISSUE (patients that were vaccinated with this vaccine after the excursion) and NO ADVERSE EVENT (No adverse event). At the time of the report, PRODUCT TEMPERATURE EXCURSION ISSUE (patients that were vaccinated with this vaccine after the excursion), POOR QUALITY PRODUCT ADMINISTERED (patients that were vaccinated with this vaccine after the excursion) 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)) (Intramuscular), the reporter considered NO ADVERSE EVENT (No adverse event) to be not related. No further causality assessments were provided for PRODUCT TEMPERATURE EXCURSION ISSUE (patients that were vaccinated with this vaccine after the excursion) and POOR QUALITY PRODUCT ADMINISTERED (patients that were vaccinated with this vaccine after the excursion).    No concomitant medication was reported.  No treatment medication was reported.
Sex: U
Vaccine: VARCEL
Symptoms: No adverse event, Overdose
Clinical narrative: No additional AE reported; got administered VARIVAX dose 2 times on the same day; This spontaneous report was received from a nurse and refers to a 5-year-old patient of unknown gender. There was no information about the patient's concurrent conditions, concomitant therapies, drug reactions, allergies or medical history provided.  On 08-NOV-2022, the patient was vaccinated with 2 doses of varicella virus vaccine live (oka/merck) (VARIVAX) subcutaneous injection, lot # W011622, expiration date was not reported however upon internal validation it was established as 06-APR-2024, 0.5 ml (route of administration and anatomical location were not provided) as prophylaxis (overdose). No additional adverse event was reported (no adverse event).
Sex: U
Vaccine: HEPA, MMR
Symptoms: Syringe issue
Clinical narrative: No additional AE's; A nurse reported that a patient received a VAQTA and a MMR II vaccine today.  One of the syringes used for one of these vaccinations leaked slightly during administration.  The nurse could not rule out either of the vaccines being the one where the s; A nurse reported that a patient received a VAQTA and a MMR II vaccine today.  One of the syringes used for one of these vaccinations leaked slightly during administration.  The nurse could not rule out either of the vaccines being the one where the s; A nurse reported that a patient received a VAQTA and a MMR II vaccine today.  One of the syringes used for one of these vaccinations leaked slightly during administration.  The nurse could not rule out either of the vaccines being the one where the s; This spontaneous report was received from a registered nurse and refers to a patient of unknown age and gender. No information regarding the patient's medical history, concurrent conditions, drug reactions or allergies were reported. The patient's concomitant medication included sterile diluent.  On 17-NOV-2022, the patient was vaccinated with Measles, Mumps, and Rubella (Wistar RA 27-3) Virus Vaccine, Live (M-M-R II) lot # reported as U003548, described as use as directed to prevent measles, mumps and rubella infection (strength, dose, expiration date, route and site of administration were not reported) and with Hepatitis A Vaccine, Inactivated (VAQTA) 25 U / 0.5 ml, lot # W006214 was confirm to be valid, expiation date was not reported, however upon internal validation was established as 04-MAR-2023, described as use as directed to prevent hepatitis A infection (exact dose, route and site of administration were not reported).  It was reported that one of the syringes used for one of these vaccinations leaked slightly during administration. The reporter could not rule out either of the vaccines being the one where the syringe leaked during administration. No additional adverse events were reported.
Sex: U
Vaccine: MMRV
Symptoms: No adverse event, Product storage error
Clinical narrative: No additional AE reported; TE on frozen vaccines reports one dose of PROQUAD was administered to one patient 17-NOV-2022; This spontaneous report was received from  a medical assistant and refers to a patient of a not reported age or gender.  The patient's medical history, concurrent conditions and previous drugs reaction or allergies were not reported. Concomitant medications included sterile diluent (manufacturer unknown).   On 17-NOV-2022, the patient was vaccinated with an improperly stored measles, mumps, rubella and varicella (oka-merck) virus vaccine live (rHA) (PROQUAD)  lot #U039955, expiration date: 14-JUN-2023, administered for prophylaxis (strength, and route of administration were not provided following a temperature excursion of -14 degree Celsius (C) up to -10 C (-13C) for 1 hour (product storage error), it was mentioned that previous temperature excursion did occurred of -14C up to -10c (-14.2C). No additional adverse event was reported.
Age: 12.0
Sex: U
Vaccine: HPV9
Symptoms: Inappropriate schedule of product administration, No adverse event
Clinical narrative: No addtional AE.; A medical assistant reported that a third dose of GARDASIL 9 was administered to a twelve year old patient who completed the two dose regimen last week.  No additional AE's and no PQC's were reported.; This spontaneous report has been received from a nurse, regarding to a 12-year-old patient of unknown age. The patient's pertinent medical history, concurrent conditions, concomitant medications, and previous drug reactions or allergies were not reported.   On 21-NOV-2022, the patient was vaccinated with hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast) (GARDASIL 9) injection, as prophylaxis for papilloma viral infection lot number: W000189, which was determined to be valid, with an expiration date on 10-AUG-2024) (strength, dose, vaccination scheme, route of administration, and anatomical site of injection were not reported).Additionally, it was reported that a third dose of hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast) (GARDASIL 9) was administered and the patient completed the two dose regimen last week (inappropriate schedule of product administration).  No additional adverse events were reported in the patient.
Sex: U
Vaccine: HEPA
Symptoms: Expired product administered, No adverse event
Clinical narrative: No additional AE reported.; Nurse reported a dose of VAQTA was inadvertently administered after the labeled expiration date; This spontaneous report was received from a registered nurse referring to a patient of unknown age and gender. Information about the patient's pertinent medical history, concurrent conditions, concomitant medications and drug reactions/ allergies was not provided.  On 28-NOV-2022 (also reported as yesterday), the patient was inadvertently vaccinated with an expired dose of hepatitis a vaccine, inactivated (VAQTA) pre-filled syringe, dose of 0.5 mL, lot number: U026792, expiration date: 28-OCT-2022 (dose number, route of administration and anatomical location were not reported) for prophylaxis (expired product administered). The reporter confirmed that the suspect vaccine did not experience any temperature excursions. No additional adverse event (AE) was reported (no adverse event).
Sex: F
Vaccine: HPV9
Symptoms: Eye swelling, Hypersensitivity, Injection site hypersensitivity, Injection site rash, Lip swelling
Clinical narrative: Patient received Gardasil 9 on 19-SEP-2022 and then had an allergic reaction; Rash at the injection site; This spontaneous report was received from Company Representative and refers to a 37-year-old female patient. No information regarding the patient's medical history, concurrent conditions, previous drug reactions or allergies and concomitant medications was provided.  On 19-SEP-2022, the patient was vaccinated with hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast) (GARDASIL 9) injection, lot #U037064, expiration date: 10-AUG-2024 (who had been verified to be a valid number), administered for prophylaxis on the right arm (strength and dose were not provided).  On 24-SEP-2022 (reported as 5 days later), the patient had an allergic reaction, the reaction consisted of swollen lips and eyes as well as a rash at the injection site (hypersensitivity-injection site rash). The outcome of the adverse events as well as the causality assessment with hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast) (GARDASIL 9) were not provided.
Sex: U
Vaccine: RV5
Symptoms: No adverse event, Product storage error
Clinical narrative: No additional AE reported.; ROTATEQ was administered after a temperature excursion to a patient on Nov 21, 2022. No further information provided. This is case two of two. Cross reference AE case: 02294619. No additional AE reported. No PQC reported. This spontaneous report has been received from a physician assistant referring to a patient of unknown age and gender. The patient's pertinent medical history, concurrent conditions, previous drug reactions, allergies, or concomitant medications were not reported.  On 21-NOV-2022, the patient was vaccinated with an improperly stored dose of rotavirus vaccine, live, oral, pentavalent (ROTATEQ) for prophylaxis (lot number U038854 had been verified to be a valid number; expiration date  20-APR-2023, and upon internal validation established as the same date) (dosage, vaccination scheme, frequency, route of administration, and anatomical site of injection were not reported). The administered dose of the vaccine was stored at a temperature of 33.9 degrees Fahrenheit (F), for a time frame of 2 hours, as recorded by a digital data logger. There was no previous temperature excursion reported. There was no adverse effect reported.
Sex: F
Vaccine: VARZOS
Symptoms: Injection site pain
Clinical narrative: Pain on the injection site; This case was reported by a consumer via interactive digital media and described the occurrence of injection site pain in a 91-year-old female patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   On an unknown date, the patient received Shingles vaccine. On an unknown date, unknown after receiving Shingles vaccine, the patient experienced injection site pain. On an unknown date, the outcome of the injection site pain was not recovered/not resolved.   It was unknown if the reporter considered the injection site pain to be related to Shingles vaccine.     Additional Information: GSK Receipt Date: 26-Nov-2022 Reporter's comment: This case was reported by a patient via (Shingrix GSK) interactive digital media. The reporter asked what he/she could give to the patient for relief of the pain on the site were she was given injection. Additional supportive information: Follow-up would not possible as no contact details were available.
Sex: U
Vaccine: VARZOS
Symptoms: Axillary pain, Chest pain, Pain in extremity
Clinical narrative: pain right armpit; pain right arm; pain right chest; This case was reported by a consumer via interactive digital media and described the occurrence of axillary pain in a patient who received Herpes zoster (Shingrix) for prophylaxis.   In November 2022, the patient received Shingrix. In November 2022, less than 2 weeks after receiving Shingrix, the patient experienced axillary pain, pain in arm and chest pain. On an unknown date, the outcome of the axillary pain and pain in arm were unknown and the outcome of the chest pain was not recovered/not resolved.   It was unknown if the reporter considered the axillary pain, pain in arm and chest pain to be related to Shingrix.     Additional Information: GSK Receipt Date: 26-NOV-2022 Reporter's Comment: This case was reported by a patient via interactive digital media. The patient received a dose of Shingrix ten days ago and reported he/she got lot left arm, but after that, he/she got pain in right armpit, in arm and in right chest for now.  Additional Supportive Information: Follow-up would not possible as no contact details were available.  From the narrative the statement got lot eft arm' was not clear but seems that patient got lot left arm so conservatively anatomical location added as left arm.
Age: 52.0
Sex: M
Vaccine: VARZOS
Symptoms: Axillary pain, Chest pain, Herpes zoster, Pain in extremity, Skin disorder
Clinical narrative: Skin trouble, look like singles, only so spot; pain right armpit; pain right armpit; Right armpit and arm sore/ I got pain again. I can see skin trouble the chest and armpit and arm.; Around right chest sore/ I got pain again. I can see skin trouble the chest and armpit and arm.; This case was reported by a consumer and described the occurrence of shingles in a 52-year-old male patient who received Herpes zoster (Shingrix) for prophylaxis.   Co-suspect products included ibuprofen (Advil) for pain in arm and chest pain.   In November 2022, the patient received Shingrix and Advil at an unknown dose once daily. In November 2022, less than 2 weeks after receiving Shingrix, the patient experienced shingles, skin disorder, axillary pain, pain in arm and chest pain. The action taken with Advil was unknown. On an unknown date, the outcome of the shingles was unknown and the outcome of the skin disorder, axillary pain, pain in arm and chest pain were not recovered/not resolved.   It was unknown if the reporter considered the shingles, skin disorder, axillary pain, pain in arm and chest pain to be related to Shingrix.     Additional Information: GSK Receipt Date: 26-NOV-2022 Reporter's comments: The patient had Shingrix shot in the left arm 10 days ago, but the right armpit and arm and around right chest were sore. He had took six Advil a day, it was a little fine, but he stated that if he did not take it, he would get the pain again. He could see skin the trouble in the chest, armpit and arm.  He stated that, it look like shingles buy not too much but only so spot. The patient would called his HCP to get advised to continued the use of Advil for the pain.Less than 2 weeks after receiving Advil, the patient experienced shingles, skin disorder. The reporter had denied to provide further contact details.It was unknown if the reporter considered the shingles, skin disorder to be related to Advil.
Sex: U
Vaccine: VARZOS
Symptoms: Herpes zoster
Clinical narrative: shingles several times; This case was reported by a consumer via interactive digital media and described the occurrence of shingles in a patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   On an unknown date, the patient received the 1st dose of Shingles vaccine. On an unknown date, unknown after receiving Shingles vaccine, the patient experienced shingles. On an unknown date, the outcome of the shingles was unknown.   It was unknown if the reporter considered the shingles to be related to Shingles vaccine.     Additional Information: GSK receipt date :29-NOV-2022 Reporters comment: This case was reported by a consumer via interactive digital media (Shingrix GSK). The patient he/she received first dose of shingle vaccine and had shingles several times.
Sex: M
Vaccine: VARZOS, VARZOS
Symptoms: Condition aggravated, Herpes zoster, Incomplete course of vaccination, Lung neoplasm malignant, Pain
Clinical narrative: 1st dose in april, unaware there was a 2nd; shingles on back and chest; is painful; Lung cancer; This case was reported by a consumer via call center representative and described the occurrence of lung cancer in a 66-year-old male patient who received Herpes zoster (Shingrix) for prophylaxis.   Co-suspect products included Herpes zoster (Shingrix) for prophylaxis.   Concurrent medical conditions included lung cancer (diagnosed with lung cancer 1 month ago).   In April 2022, the patient received the 1st dose of Shingrix (intramuscular) .5 ml. On an unknown date, the patient received the 2nd dose of Shingrix. In October 2022, between 5 and 7 months after receiving Shingrix and not applicable after receiving Shingrix, the patient experienced lung cancer (serious criteria GSK medically significant). On 15th November 2022, the patient experienced shingles and pain. On an unknown date, the patient experienced incomplete course of vaccination. The patient was treated with valaciclovir (Valacyclovir), acyclovir and trolamine salicylate (Aspercreme). On an unknown date, the outcome of the lung cancer, shingles and pain were not recovered/not resolved and the outcome of the incomplete course of vaccination was unknown.   It was unknown if the reporter considered the lung cancer, shingles and pain to be related to Shingrix.     Additional Information: GSK Receipt Date: 29-NOV-2022 Reporter's Comments:  This case was self reported by the patient. The patient received first Shingrix vaccine on the left arm. The patient developed shingles. The patient had not one ever told him there was a second Shingrix vaccine (Inappropriate Schedule of Vaccine).  The patient had shingles on back and chest that was painful.  The healthcare professional started patient with Valacyclovir tabs and Acyclovir Ointment about 4 days ago.  The pharmacist gave him Aspercreme spray to use topically.  The pharmacist told that the patient could get shingles from the vaccine.  Informed caller that this was a non-live vaccine.  The pharmacist reported the patient cannot start chemotherapy until shingles would cleared up.  The reporter consented to follow up.  The reporter gave permission for GSK to contact the physician and the pharmacy healthcare professional info redacted. Between 6 and 8 months, the patient experienced shingles and pain.  Additional supportive information: Till the time of reporting, the patient did not receive the 2nd dose, which led to incomplete course of vaccination.
Sex: F
Vaccine: COVID19
Symptoms: Death, Haematemesis, Pneumonia
Clinical narrative: THROWING BLOOD CLOT; PNEUMONIA; DEATH; This spontaneous report received from a consumer via a company representative via social media concerned a female of unspecified age, race and ethnic origin. 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: unknown expiry: unknown) dose not reported, 01 total was administered on an unspecified date 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, shortly after vaccination the patient health went south and was throwing blood clots, had pneumonia and could not get rid of it. The patient went into the hospital alive on 03-MAY-2022 left in a body bag on 12-MAY-2022 (hospitalized for 9 days) and on an unspecified date in MAY-2022  the patient died from unknown cause of death. It was unspecified whether an autopsy was performed or not. As per the consumer, "my sister had the same thing happen to her. She got the and shortly after her health went south and was throwing blood clots, had pneumonia and could not get rid of it. She went into the hospital alive 03-MAY-2022 left in a body bag 12-MAY-2022. The kill" The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient died of death on MAY-2022, had not recovered from pneumonia, and the outcome of throwing blood clot was not reported. This report was serious (Death, and Hospitalization Caused / Prolonged).; Sender's Comments: V0: 20221163787- Death. Insufficient information is available to make a causality assessment. Therefore, this event is considered unclassifiable. 20221163787- Throwing blood clot, Pneumonia. The event has an unknown/unclear temporal relationship, is unlabeled, and has unknown scientific plausibility. There is no information on any other factors potentially associated with the event. Therefore, the WHO Causality is considered indeterminate. The company causality is considered unassessable.; Reported Cause(s) of Death: UNKNOWN CAUSE OF DEATH
Sex: U
Vaccine: PPV
Symptoms: Expired product administered, No adverse event
Clinical narrative: No additional AEs; an expired dose of PNEUMOVAX 23 was administered on 11/08/2022; This spontaneous report was received from a pharmacy technician and refers to a patient of unknown gender and age. There was no information about the patient's pertinent medical history, concomitant medications or drug reactions and allergies.  On 08-NOV-2022, the patient was vaccinated with an expired dose of pneumococcal vaccine, polyvalent (23-valent) (PNEUMOVAX 23) prefilled syringe, injection, lot U010533, expiration date 29-OCT-2022 (exact dose, route of administration and anatomical location were not reported) for prophylaxis (Expired product administered). No additional adverse events were reported (No adverse event).
Age: 61.0
Sex: F
Vaccine: COVID19
Symptoms: Expired product administered, No adverse event
Clinical narrative: No adverse event; pt received an 2 day expired dose; This spontaneous case was reported by an other health care professional and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (pt received an 2 day expired dose) and NO ADVERSE EVENT (No adverse event) in a 61-year-old female patient who received mRNA-1273 (Spikevax) (batch no. 061B22A) for COVID-19 prophylaxis.     No Medical History information was reported.    On 29-Nov-2022, the patient received first dose of mRNA-1273 (Spikevax) (Intramuscular) .5 milliliter. On 29-Nov-2022, the patient experienced EXPIRED PRODUCT ADMINISTERED (pt received an 2 day expired dose). On an unknown date, the patient experienced NO ADVERSE EVENT (No adverse event). At the time of the report, EXPIRED PRODUCT ADMINISTERED (pt received an 2 day expired dose) and NO ADVERSE EVENT (No adverse event) outcome was unknown.        For mRNA-1273 (Spikevax) (Intramuscular), the reporter considered NO ADVERSE EVENT (No adverse event) to be not related. No further causality assessment was provided for EXPIRED PRODUCT ADMINISTERED (pt received an 2 day expired dose).    No concomitant medication was reported.  It was unknown if the patient experienced any additional symptoms/events.  No treatment information was provided.
Sex: U
Vaccine: COVID19
Symptoms: No adverse event, Off label use
Clinical narrative: received 0.25 ml of bivalent booster 10 days apart; No adverse event; This spontaneous case was reported by a pharmacist and describes the occurrence of OFF LABEL USE (received 0.25 ml of bivalent booster 10 days apart) and NO ADVERSE EVENT (No adverse event) in an adult patient of an unknown gender who received mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) for COVID-19 prophylaxis.     No Medical History information was reported.   On an unknown date, the patient received dose of mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (unknown route) .25 milliliter. On an unknown date, received dose of mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (unknown route) dosage was changed to .25 milliliter. On an unknown date, the patient experienced OFF LABEL USE (received 0.25 ml of bivalent booster 10 days apart) and NO ADVERSE EVENT (No adverse event). At the time of the report, OFF LABEL USE (received 0.25 ml of bivalent booster 10 days apart) 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 OFF LABEL USE (received 0.25 ml of bivalent booster 10 days apart).    No concomitant medications were reported.  1 patient (Adult) unintentionally received a 0.25mL dose of the Moderna Bivalent Booster as a "make-up" dose 10 days later, the patient only received an additional 0.25mL again.  No treatment medications were reported.   This case was linked to MOD-2022-679099 (Patient Link).
Age: 4.0
Sex: F
Vaccine: COVID19, DTAPIPV
Symptoms: Expired product administered, No adverse event, Product storage error
Clinical narrative: Vaccine administered after 30-day Use By Date/vial exposed to room temperature for more than 24 hours; No Adverse event; Vaccine administered more than 12 hours post puncture and after 30-day Use By Date; This spontaneous case was reported by a nurse and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Vaccine administered more than 12 hours post puncture and after 30-day Use By Date), PRODUCT STORAGE ERROR (Vaccine administered after 30-day Use By Date/vial exposed to room temperature for more than 24 hours) and NO ADVERSE EVENT (No Adverse event) in a 4-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. AR9236B) for COVID-19 vaccination.    Co-suspect product included non-company product QUADRACEL for an unknown indication.    No Medical History information was reported.   On 21-Nov-2022, the patient received dose of QUADRACEL (Intramuscular) .5 milliliter. On 21-Nov-2022 at 4:23 PM, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 21-Nov-2022 at 4:23 PM, the patient experienced EXPIRED PRODUCT ADMINISTERED (Vaccine administered more than 12 hours post puncture and after 30-day Use By Date). On an unknown date, the patient experienced PRODUCT STORAGE ERROR (Vaccine administered after 30-day Use By Date/vial exposed to room temperature for more than 24 hours) and NO ADVERSE EVENT (No Adverse event). At the time of the report, EXPIRED PRODUCT ADMINISTERED (Vaccine administered more than 12 hours post puncture and after 30-day Use By Date), PRODUCT STORAGE ERROR (Vaccine administered after 30-day Use By Date/vial exposed to room temperature for more than 24 hours) and NO ADVERSE EVENT (No Adverse event) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter considered NO ADVERSE EVENT (No Adverse event) to be not related. No further causality assessments were provided for EXPIRED PRODUCT ADMINISTERED (Vaccine administered more than 12 hours post puncture and after 30-day Use By Date) and PRODUCT STORAGE ERROR (Vaccine administered after 30-day Use By Date/vial exposed to room temperature for more than 24 hours).    No concomitant products reported.  Nurse reported that 1st primary dose of Moderna Monovalent was administered to a patient on 21 Nov 2022, more than 12 hours post puncture and after 30 day use by date. Vial size was 2.5 ml. The vial was initially stored in the refrigerator on 18 Oct 2022. The vial was first punctured on 18 Nov 2022 around 9 AM. The administration of vaccine was on 21 Nov 2022 at 4:23 pm. The vial stored post puncture returned to the fridge. The vial did not undergo any temperature excursions. The vial exposed to room temperature for more than 24 hours. The patient did not ever had COVID positive test or diagnosis. Patient received additional vaccines on 21 Nov 2022. 5th dose of QUADRACEL MMR Lot number: W024973.  No treatment products reported.
Sex: U
Vaccine: COVID19
Symptoms: Expired product administered, No adverse event
Clinical narrative: No Adverse Event; administered primary series dose that was expired.; This spontaneous case was reported by a nurse and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (administered primary series dose that was expired.) and NO ADVERSE EVENT (No Adverse Event) in a  patient of an unknown age and gender who received mRNA-1273 (Spikevax) (batch no. 082B22A) for COVID-19 prophylaxis.     No Medical History information was reported.    On 30-Nov-2022, the patient received dose of mRNA-1273 (Spikevax) (unknown route) 1 dosage form. On 30-Nov-2022, the patient experienced EXPIRED PRODUCT ADMINISTERED (administered primary series dose that was expired.). On an unknown date, the patient experienced NO ADVERSE EVENT (No Adverse Event). At the time of the report, EXPIRED PRODUCT ADMINISTERED (administered primary series dose that was expired.) and NO ADVERSE EVENT (No Adverse Event) outcome was unknown.        The action taken with mRNA-1273 (Spikevax) (Unknown) 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 EXPIRED PRODUCT ADMINISTERED (administered primary series dose that was expired.).    No concomitant medicine were reported. It was reported that the vaccine was removed from the refrigerator on November 9th. No treatment medicine were reported.   Most recent FOLLOW-UP information incorporated above includes: On 01-Dec-2022: Live follow up received and updated iNarrative supplement.
Age: 69.0
Sex: F
Vaccine: COVID19
Symptoms: Accidental underdose, No adverse event
Clinical narrative: no adverse event; Patient reporting that facility gave her 1/2 dose of Moderna Bivalent vaccine on 30Sep2022; This spontaneous case was reported by a patient and describes the occurrence of ACCIDENTAL UNDERDOSE (Patient reporting that facility gave her 1/2 dose of Moderna Bivalent vaccine on 30Sep2022) and NO ADVERSE EVENT (no adverse event) in a 69-year-old female patient who received mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) for COVID-19 vaccination.     No Medical History information was reported.    On 30-Sep-2022, the patient received dose of mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (Intramuscular) 1 dosage form. On 30-Sep-2022, the patient experienced ACCIDENTAL UNDERDOSE (Patient reporting that facility gave her 1/2 dose of Moderna Bivalent vaccine on 30Sep2022). On an unknown date, the patient experienced NO ADVERSE EVENT (no adverse event). At the time of the report, ACCIDENTAL UNDERDOSE (Patient reporting that facility gave her 1/2 dose of Moderna Bivalent vaccine on 30Sep2022) and NO ADVERSE EVENT (no adverse event) outcome was unknown.            Concomitant medication was not reported. Treatment medication was not reported.   Reporter did not allow further contact
Sex: F
Vaccine: COVID19
Symptoms: Vasculitis
Clinical narrative: My mother-in-law suddenly got vasculitis; This spontaneous case was reported by a patient family member or friend and describes the occurrence of VASCULITIS (My mother-in-law suddenly got vasculitis) in a female patient of an unknown age who received mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) for COVID-19 prophylaxis.  No Medical History information was reported.   On an unknown date, 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 an unknown date, the patient experienced VASCULITIS (My mother-in-law suddenly got vasculitis). At the time of the report, VASCULITIS (My mother-in-law suddenly got vasculitis) outcome was unknown.     Concomitant medication not reported. Treatment medication not reported.  Reporter did not allow further contact
Age: 52.0
Sex: M
Vaccine: COVID19
Symptoms: Expired product administered, No adverse event, Poor quality product administered, Product storage error, Product temperature excursion issue
Clinical narrative: The (BUD) refrigeration date  on 27-Jul-2022 and vaccine was adminstered on 29-Jul-2022; The vial had undergone temperature excursion; Administered the vial  which had undergone temperature excursion; No adverse event; erroneously vaccinated clients with expired vaccine; This spontaneous case was reported by a nurse and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (erroneously vaccinated clients with expired vaccine), PRODUCT STORAGE ERROR (The (BUD) refrigeration date  on 27-Jul-2022 and vaccine was adminstered on 29-Jul-2022), PRODUCT TEMPERATURE EXCURSION ISSUE (The vial had undergone temperature excursion), POOR QUALITY PRODUCT ADMINISTERED (Administered the vial  which had undergone temperature excursion) and NO ADVERSE EVENT (No adverse event) in a 52-year-old male patient who received mRNA-1273 (Spikevax) (batch no. 017B22A) for COVID-19 prophylaxis.     No Medical History information was reported.    On 29-Jul-2022, the patient received dose of mRNA-1273 (Spikevax) (unknown route) 1 dosage form. On 29-Jul-2022, the patient experienced EXPIRED PRODUCT ADMINISTERED (erroneously vaccinated clients with expired vaccine). On an unknown date, the patient experienced PRODUCT STORAGE ERROR (The (BUD) refrigeration date  on 27-Jul-2022 and vaccine was adminstered on 29-Jul-2022), PRODUCT TEMPERATURE EXCURSION ISSUE (The vial had undergone temperature excursion), POOR QUALITY PRODUCT ADMINISTERED (Administered the vial  which had undergone temperature excursion) and NO ADVERSE EVENT (No adverse event). At the time of the report, EXPIRED PRODUCT ADMINISTERED (erroneously vaccinated clients with expired vaccine), PRODUCT STORAGE ERROR (The (BUD) refrigeration date  on 27-Jul-2022 and vaccine was adminstered on 29-Jul-2022), PRODUCT TEMPERATURE EXCURSION ISSUE (The vial had undergone temperature excursion), POOR QUALITY PRODUCT ADMINISTERED (Administered the vial  which had undergone temperature excursion) 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 assessments were provided for EXPIRED PRODUCT ADMINISTERED (erroneously vaccinated clients with expired vaccine), PRODUCT STORAGE ERROR (The (BUD) refrigeration date  on 27-Jul-2022 and vaccine was adminstered on 29-Jul-2022), PRODUCT TEMPERATURE EXCURSION ISSUE (The vial had undergone temperature excursion) and POOR QUALITY PRODUCT ADMINISTERED (Administered the vial  which had undergone temperature excursion).    Concomitant medication was not reported.  It was reported that the patient was administered dose after 30 days use by date which was 2 days past expiry date. The vial was kept in refrigerator on 27-Jun-2022 and the (BUD) refrigeration date was 27-Jul-2022. The size of the vial was 5.5 ml.   Treatment medication was not reported.   This case was linked to MOD-2022-681319 (Patient Link).
Age: 57.0
Sex: F
Vaccine: COVID19
Symptoms: Expired product administered, No adverse event, Product storage error
Clinical narrative: The vial was initially stored in the refrigerator on 07-Jun-2022 and was administered on 11-Jul-2022; No adverse event; erroneously vaccinated  clients with expired vaccine; This spontaneous case was reported by a nurse and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (erroneously vaccinated  clients with expired vaccine), PRODUCT STORAGE ERROR (The vial was initially stored in the refrigerator on 07-Jun-2022 and was administered on 11-Jul-2022) and NO ADVERSE EVENT (No adverse event) in a 57-year-old female patient who received mRNA-1273 (Spikevax) (batch no. 058A22-2A) for COVID-19 prophylaxis.     No Medical History information was reported.    On 11-Jul-2022, the patient received dose of mRNA-1273 (Spikevax) (unknown route) 1 dosage form. On 11-Jul-2022, the patient experienced EXPIRED PRODUCT ADMINISTERED (erroneously vaccinated  clients with expired vaccine). On an unknown date, the patient experienced PRODUCT STORAGE ERROR (The vial was initially stored in the refrigerator on 07-Jun-2022 and was administered on 11-Jul-2022) and NO ADVERSE EVENT (No adverse event). At the time of the report, EXPIRED PRODUCT ADMINISTERED (erroneously vaccinated  clients with expired vaccine), PRODUCT STORAGE ERROR (The vial was initially stored in the refrigerator on 07-Jun-2022 and was administered on 11-Jul-2022) 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 assessments were provided for EXPIRED PRODUCT ADMINISTERED (erroneously vaccinated  clients with expired vaccine) and PRODUCT STORAGE ERROR (The vial was initially stored in the refrigerator on 07-Jun-2022 and was administered on 11-Jul-2022).    No concomitant medications were reported.  The Beyond use date (BUD) (refrigerator) was reported as 01-Jul-2022. It was reported that 10 days past expiry date the patient received the vaccine. Vial size was reported as 5.5 ml. Vial did not undergo any temperature excursion.   No treatment medications were reported.
Age: 44.0
Sex: F
Vaccine: COVID19
Symptoms: Expired product administered, No adverse event, Product storage error, Product temperature excursion issue
Clinical narrative: The vial was initially stored in the refrigerator on 03 Oct 2022 and was administered on 11 Nov 2022.; Temp Excursion - Yes; No adverse event; erroneously vaccinated  clients with expired vaccine; This spontaneous case was reported by a nurse and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (erroneously vaccinated  clients with expired vaccine), PRODUCT STORAGE ERROR (The vial was initially stored in the refrigerator on 03 Oct 2022 and was administered on 11 Nov 2022.), PRODUCT TEMPERATURE EXCURSION ISSUE (Temp Excursion - Yes) and NO ADVERSE EVENT (No adverse event) in a 44-year-old female patient who received mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (batch no. 057F22A) for COVID-19 prophylaxis.     No Medical History information was reported.    On 11-Nov-2022, 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 11-Nov-2022, the patient experienced EXPIRED PRODUCT ADMINISTERED (erroneously vaccinated  clients with expired vaccine). On an unknown date, the patient experienced PRODUCT STORAGE ERROR (The vial was initially stored in the refrigerator on 03 Oct 2022 and was administered on 11 Nov 2022.), PRODUCT TEMPERATURE EXCURSION ISSUE (Temp Excursion - Yes) and NO ADVERSE EVENT (No adverse event). At the time of the report, EXPIRED PRODUCT ADMINISTERED (erroneously vaccinated  clients with expired vaccine), PRODUCT STORAGE ERROR (The vial was initially stored in the refrigerator on 03 Oct 2022 and was administered on 11 Nov 2022.), PRODUCT TEMPERATURE EXCURSION ISSUE (Temp Excursion - Yes) 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 (erroneously vaccinated  clients with expired vaccine), PRODUCT STORAGE ERROR (The vial was initially stored in the refrigerator on 03 Oct 2022 and was administered on 11 Nov 2022.) and PRODUCT TEMPERATURE EXCURSION ISSUE (Temp Excursion - Yes).    No concomitant drug was provided by reporter. No treatment drug was provided by reporter.
Age: 63.0
Sex: M
Vaccine: COVID19
Symptoms: Expired product administered, No adverse event, Product storage error, Product temperature excursion issue
Clinical narrative: vial undergo temperature excursions; The vial was initially stored in the refrigerator on 3-Oct-2022 and was administered on 11-Nov-2022; No adverse event; erroneously vaccinated with expired vaccine; This spontaneous case was reported by an other health care professional and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (erroneously vaccinated with expired vaccine), PRODUCT TEMPERATURE EXCURSION ISSUE (vial undergo temperature excursions), PRODUCT STORAGE ERROR (The vial was initially stored in the refrigerator on 3-Oct-2022 and was administered on 11-Nov-2022) and NO ADVERSE EVENT (No adverse event) in a 63-year-old male patient who received mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (batch no. 057F22A) for COVID-19 prophylaxis.     No Medical History information was reported.    On 11-Nov-2022, 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 11-Nov-2022, the patient experienced EXPIRED PRODUCT ADMINISTERED (erroneously vaccinated with expired vaccine). On an unknown date, the patient experienced PRODUCT TEMPERATURE EXCURSION ISSUE (vial undergo temperature excursions), PRODUCT STORAGE ERROR (The vial was initially stored in the refrigerator on 3-Oct-2022 and was administered on 11-Nov-2022) and NO ADVERSE EVENT (No adverse event). At the time of the report, EXPIRED PRODUCT ADMINISTERED (erroneously vaccinated with expired vaccine), PRODUCT TEMPERATURE EXCURSION ISSUE (vial undergo temperature excursions), PRODUCT STORAGE ERROR (The vial was initially stored in the refrigerator on 3-Oct-2022 and was administered on 11-Nov-2022) 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 (erroneously vaccinated with expired vaccine), PRODUCT TEMPERATURE EXCURSION ISSUE (vial undergo temperature excursions) and PRODUCT STORAGE ERROR (The vial was initially stored in the refrigerator on 3-Oct-2022 and was administered on 11-Nov-2022).    No concomitant medications were reported. It was reported that the patient was administered dose after 30 days use by date which was 9 days past expiry date. The vial was kept in refrigerator on 03-Oct-2022 and the (BUD) refrigeration date was 02-Nov-2022. The size of the vial was 2.5 ml. No treatment information was reported.   This case was linked to US-MODERNATX, INC.-MOD-2022-681156 (E2B Linked Report).; Sender's Comments:  US-MODERNATX, INC.-MOD-2022-681156:
Age: 66.0
Sex: F
Vaccine: COVID19
Symptoms: Expired product administered, No adverse event, Product storage error, Product temperature excursion issue
Clinical narrative: The vial was initially stored in the refrigerator on 03Oct2022, BUD was reported as 02Nov2022 and was administered on 11Nov2022; Temp Excursion  Yes; No adverse event; Erroneously vaccinated clients with expired vaccine; This spontaneous case was reported by a nurse and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Erroneously vaccinated clients with expired vaccine), PRODUCT STORAGE ERROR (The vial was initially stored in the refrigerator on 03Oct2022, BUD was reported as 02Nov2022 and was administered on 11Nov2022), PRODUCT TEMPERATURE EXCURSION ISSUE (Temp Excursion  Yes) and NO ADVERSE EVENT (No adverse event) in a 66-year-old female patient who received mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (batch no. 057F22A) for COVID-19 prophylaxis.     No Medical History information was reported.    On 11-Nov-2022, 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 11-Nov-2022, the patient experienced EXPIRED PRODUCT ADMINISTERED (Erroneously vaccinated clients with expired vaccine). On an unknown date, the patient experienced PRODUCT STORAGE ERROR (The vial was initially stored in the refrigerator on 03Oct2022, BUD was reported as 02Nov2022 and was administered on 11Nov2022), PRODUCT TEMPERATURE EXCURSION ISSUE (Temp Excursion  Yes) and NO ADVERSE EVENT (No adverse event). At the time of the report, EXPIRED PRODUCT ADMINISTERED (Erroneously vaccinated clients with expired vaccine), PRODUCT STORAGE ERROR (The vial was initially stored in the refrigerator on 03Oct2022, BUD was reported as 02Nov2022 and was administered on 11Nov2022), PRODUCT TEMPERATURE EXCURSION ISSUE (Temp Excursion  Yes) 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 (Erroneously vaccinated clients with expired vaccine), PRODUCT STORAGE ERROR (The vial was initially stored in the refrigerator on 03Oct2022, BUD was reported as 02Nov2022 and was administered on 11Nov2022) and PRODUCT TEMPERATURE EXCURSION ISSUE (Temp Excursion  Yes).    No concomitant medication was reported.  It was reported that the patient was administered dose after 30 day use by date. The size of the vial was 2.5 ml. The vial was initially stored in the refrigerator on 03-Oct-2022 and was administered on 11-Nov-2022. Beyond use date was reported as 02-Nov-2022. The vial underwent temperature excursion. 9 days past expiry date the patient received the vaccine.  No treatment information was provided by the reporter.   This case was linked to MOD-2022-514142 (Patient Link).