chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 36.0
Sex: M
Vaccine: DTAP
Symptoms: Underdose, Wrong product administered
Clinical narrative: Infanrix administered to 36 year old patient; Patient got infanrix instead of boostrix; This non-serious case was reported by a other health professional via call center representative and described the occurrence of adult use of a child product in a 36-year-old male patient who received DTPa (Infanrix) for prophylaxis.   On 20-APR-2023, the patient received Infanrix. On 20-APR-2023, an unknown time after receiving Infanrix, the patient experienced adult use of a child product (Verbatim: Infanrix administered to 36 year old patient) and wrong vaccine administered (Verbatim: Patient got infanrix instead of boostrix). The outcome of the adult use of a child product and wrong vaccine administered were unknown.   This report is made by GSK without prejudice and does not imply any admission or liability for the incident or its consequences.   Additional Information: GSK Receipt Date: 21-APR-2023 The Health care professional reported that a 36 years old male patient received an Infanrix instead of a boostrix dose. The reporter gave consent to follow up. A 36 years old patient received Infanrix against the recommended age group which led to adult use of a child product. The patient intended to receive boostrix however received Infanrix instead of boostrix, which led to wrong vaccine administered.
Age: 67.0
Sex: F
Vaccine: VARZOS
Symptoms: Extra dose administered
Clinical narrative: Patient had third Shingrix shots; This non-serious case was reported by a pharmacist via call center representative and described the occurrence of extra dose administered in a 67-year-old female patient who received Herpes zoster (Shingrix) (batch number FM3YT, expiry date 17-FEB-2024) for prophylaxis.   Previously administered products included Shingrix (first dose received on 16 August 2019) and Shingrix (second dose received on 04 November 2019).   On 16-JAN-2023, the patient received the 3rd dose of Shingrix. On 16-JAN-2023, an unknown time after receiving Shingrix, the patient experienced extra dose administered (Verbatim: Patient had third Shingrix shots). The outcome of the extra dose administered was unknown.   Additional Information: GSK receipt date: 21-Apr-2023 There was chat with pharmacist that is there a way to search Shingrix vaccines by lot number. The patient had received first on 16 August 2019, second dose 04 November 2019 and third dose on 16 January 2023. The patient had an immunization record stated that they had 3 Shingrix shots, but was convinced one of them entered incorrectly.  The patient wanted to know that if there was a tool to look up Shingrix by lot numbers. The pharmacist would inform the patient that their series was completed and no additional shots were necessary.  The pharmacist stated that it was appeared that last dose was administered in error.  The reporter consented to follow up via postal.  The vaccine administration facility was the same as primary reporter. The pharmacist was able to confirm that the lot numbers provided by the healthcare professional were all Shingrix. The patient received the 3rd shot of Shingrix which led to extra dose administered.
Age: 88.0
Sex: F
Vaccine: VARZOS, VARZOS
Symptoms: Extra dose administered, Inappropriate schedule of product administration
Clinical narrative: An accidental 3rd dose; A late 2nd dose; This non-serious case was reported by a pharmacist via call center representative and described the occurrence of extra dose administered in a 88-year-old female patient who received Herpes zoster (Shingrix) (batch number 2BR9G, expiry date 09-JUL-2024) for prophylaxis.   Co-suspect products included Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included Shingrix (The patient received the 1st dose of Shingrix on 17-Aug-2020.).   On 21-APR-2023, the patient received the 3rd dose of Shingrix. On 01-SEP-2022, the patient received the 2nd dose of Shingrix. On 01-SEP-2022, not applicable after receiving Shingrix and an unknown time after receiving Shingrix, the patient experienced drug dose administration interval too long (Verbatim: A late 2nd dose). On 21-APR-2023, the patient experienced extra dose administered (Verbatim: An accidental 3rd dose). The outcome of the extra dose administered and drug dose administration interval too long were unknown.   Additional Information: GSK Receipt Date: 21-APR-2023 The pharmacist reported that the patient received the 1st dose of Shingrix on 17-Aug-2020, a late 2nd dose on 01-Sep-2022, and an accidental 3rd dose on 21-Apr-2023, which led to drug dose administration interval too long and extra dose administered. Patient received 3rd dose at the pharmacy. Details provided for 3rd dose of shingrix. The reporter consented to follow up.
Sex: U
Vaccine: MNQ
Symptoms: Incorrect dose administered, Product preparation error
Clinical narrative: Menveo powder portion reconstitution with sterile water; Menveo powder portion reconstitution with sterile water; This non-serious case was reported by a other health professional via call center representative and described the occurrence of wrong solution used in drug reconstitution in a patient who received Men ACWY-CRM NVS (Menveo) for prophylaxis.   On an unknown date, the patient received Menveo. On an unknown date, an unknown time after receiving Menveo, the patient experienced wrong solution used in drug reconstitution (Verbatim: Menveo powder portion reconstitution with sterile water) and inappropriate dose of vaccine administered (Verbatim: Menveo powder portion reconstitution with sterile water). The outcome of the wrong solution used in drug reconstitution and inappropriate dose of vaccine administered were unknown.   Additional Information: GSK Receipt Date: 21-APR-2023 The reporter was a medical assistant. The reporter reported that the patient received a dose of Menveo vaccine were the powder portion was reconstituted using sterile water. The reporter stated that it was not sure which date this incident was occurred. The vaccine administration facility was the same as primary reporter. The reporter asked to verify if all five patient received Menveo vaccine with a wrong reconstitution, and they can be revaccinated.  The reporter only know that five patient were vaccinated with Menveo vaccine and one of them received Menveo with the wrong reconstitution. The reporter did not consent to follow up. Menveo vaccine reconstituted with sterile water instead of the supplied CYW-135 liquid conjugate, which led to Wrong solution used in drug reconstitution and inappropriate dose of vaccine administered.
Sex: M
Vaccine: VARZOS
Symptoms: Expired product administered
Clinical narrative: Expired dose administered; This non-serious case was reported by a pharmacist via call center representative and described the occurrence of expired vaccine used in a 55-year-old male patient who received Herpes zoster (Shingrix) (batch number 9ey93, expiry date 15-APR-2023) for prophylaxis.   On 17-APR-2023, the patient received Shingrix. On 17-APR-2023, an unknown time after receiving Shingrix, the patient experienced expired vaccine used (Verbatim: Expired dose administered). The outcome of the expired vaccine used was unknown.   Additional Information: GSK Receipt Date: 21-APR-2023 The vaccine administration facility was the same as primary reporter. The reporter did consent to follow up via email. The patient received a Shingrix which was already expired, which led to expired vaccine used. This case had been linked with US2023059006 by same reporter for different patient.; Sender's Comments:  US-GSK-US2023059006:Same report/Other patient
Sex: F
Vaccine: VARZOS
Symptoms: Expired product administered
Clinical narrative: Expired vaccine administered; This non-serious case was reported by a pharmacist via call center representative and described the occurrence of expired vaccine used in a 53-year-old female patient who received Herpes zoster (Shingrix) (batch number 9ey93, expiry date 15-APR-2023) for prophylaxis.   On 17-APR-2023, the patient received Shingrix. On 17-APR-2023, an unknown time after receiving Shingrix, the patient experienced expired vaccine used (Verbatim: Expired vaccine administered). The outcome of the expired vaccine used was unknown.   Additional Information: GSK Receipt Date: 21-APR-2023 The vaccine administration facility was the same as primary reporter. The reporter did consent to follow up via email. The patient received a Shingrix which was already expired, which led to expired vaccine used. This case had been linked with US2023059003 by same reporter for different patient.; Sender's Comments:  US-GSK-US2023059003:Same report/Other patient
Sex: F
Vaccine: VARZOS
Symptoms: COVID-19
Clinical narrative: COVID; This non-serious case was reported by a consumer via call center representative and described the occurrence of covid-19 in a adult female patient who received Herpes zoster (Shingrix) for prophylaxis.   On an unknown date, the patient received Shingrix. On an unknown date, an unknown time after receiving Shingrix, the patient experienced covid-19 (Verbatim: COVID). The outcome of the covid-19 was unknown.   It was unknown if the reporter considered the covid-19 to be related to Shingrix.     It was unknown if the company considered the covid-19 to be related to Shingrix.   Additional Information: GSK Receipt Date: 21-APR-2023 The adult patient reported the after the vaccination with Shingrix, experienced covid. It was not known that after which dose the patient experienced covid. Limited information provided.
Sex: U
Vaccine: MENB
Symptoms: Incomplete course of vaccination
Clinical narrative: 26 YO patient did not get 2nd dose; This non-serious case was reported by a pharmacist via call center representative and described the occurrence of incomplete course of vaccination in a 26-year-old patient who received Men B NVS (Bexsero) for prophylaxis.   Previously administered products included Bexsero (1st dose received on an unknown date at 22 years of age).   On an unknown date, the patient did not receive the 2nd dose of Bexsero. On an unknown date, an unknown time after receiving Bexsero, the patient experienced incomplete course of vaccination (Verbatim: 26 YO patient did not get 2nd dose). The outcome of the incomplete course of vaccination was unknown.   This report is made by GSK without prejudice and does not imply any admission or liability for the incident or its consequences.   Additional Information: GSK receipt date: 21-APR-2023 The second dose had not yet been given.  The vaccine administration facility was the same as primary reporter. The health care professional (HCP) declined to provide any adverse event details at this time, but did consent to safety team follow up. Till the time of reporting, the patient did not receive 2nd dose of Bexsero, which led to incomplete course of vaccination.
Sex: M
Vaccine: COVID19
Symptoms: Injury, Malaise, Mental disorder
Clinical narrative: MENTAL INJURY / NOT MENTALLY OK AT ALL; PHYSICAL INJURIES; VERY ILL; This spontaneous report received from a consumer concerned a male of an unspecified age, race and ethnicity. The patient's weight, height, and medical history were not reported. The patient previously received covid-19 vaccine ad26.cov2.s (Dose number in series 1) (suspension for injection, route of admin was not reported, batch number: unknown, expiry: unknown) dose was not reported, 1 total administered on MAY-2021 for covid-19 prophylaxis. The patient experienced difficulty remembering anything that has occurred, mental injury / not mentally ok at all, physical injuries and very ill (Dose number in series 1). The patient had not recovered from difficulty remembering anything that has occurred, mental injury / not mentally ok at all, physical injuries and very ill. The patient received booster dose of covid-19 vaccine ad26.cov2.s (Dose number in series 2) (suspension for injection, route of admin was not reported, batch number: unknown, expiry: unknown) dose was not reported, 1 total administered on DEC-2021 for covid-19 prophylaxis. The batch number was not reported and has been requested. No concomitant medications were reported.  On an unspecified date, patient became very ill, had mental injury / not mentally ok at all and physical injuries from the shots (Dose number in series 2). The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from very ill, mental injury / not mentally ok at all, and physical injuries. This report was non-serious. This case, involving the same patient is linked to 20230429085. This case, from the same reporter is linked to 20230108455 and 20230109456.; Sender's Comments: V0: Medical assessment comment not required as per standard procedure as case assessed as non-serious.
Sex: M
Vaccine: COVID19
Symptoms: Death
Clinical narrative: DEATH; This spontaneous report received from a consumer via a company representative concerned a male of an unspecified age, race and ethnicity. 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 was not reported, batch number: unknown, expiry: unknown) dose was not reported, 1 total was administered on an unspecified date 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 died (death) after vaccination. The patient died from an unknown cause of death. It was not reported whether an autopsy was performed or not. It was reported that "serial killers, killed his father with the chemical injection for the renamed common flu/ cold, and it will never stop the body from detoxing itself, like it should do to keep a body healthy, unlike the method of "healing" witch we know was nothing more than slowly poisoning people for money". The action taken with covid-19 vaccine ad26.cov2.s was not applicable. This report was serious (Death).; Sender's Comments: V0-20230455597- Death-Insufficient information is available to make a causality assessment. Therefore, this event is considered unclassifiable.; Reported Cause(s) of Death: UNKNOWN CAUSE OF DEATH
Age: 60.0
Sex: M
Vaccine: COVID19
Symptoms: Blood glucose, Blood glucose increased, Confusional state, Mental impairment, Vomiting
Clinical narrative: DIFFICULTY THINKING; CONFUSION; HIGH BLOOD SUGARS IN 200S LAST A1C UNREMARKABLE AT 6 POINT 2 PERCENT; VOMITING/THROWING UP STUFF/ VIOLENT VOMITING ONCE A WEEK; This spontaneous report received from a patient via another pharmaceutical company concerned a 60 year old male of an unspecified race and ethnicity. The patient's height, and weight were not reported. The patient's concurrent conditions included: malignant neoplasm of prostate (prostate cancer). The patient was receiving treatment with non-company suspect drug included: enzalutamide (capsule, oral, batch number: 1902517 expiry: 31-OCT-2024) 160 mg, 1 time every 1 day, from 17-SEP-2020 for malignant neoplasm of prostate (prostate cancer). On an unspecified date in APR-2022, the patient had second degree burn from french onion soup spill (intensity: mild). The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin, batch number and expiry date were not reported) dose was not reported, 1 total was administered on an unspecified date in SEP-2022 for covid-19 prophylaxis. The batch number was not reported. The Company is unable to perform follow-up to request batch/lot numbers. Age at time of vaccination 60 years old. Concomitant medications included baclofen, diltiazem hydrochloride, dulaglutide, famotidine, gabapentin, hydralazine, insulin aspart, insulin glargine, insulin human/insulin human injection, isophane, ipratropium, leuprorelin acetate, lisinopril, macrogol 3350, montelukast sodium, morphine sulfate, omeprazole, ondansetron hydrochloride, oxycodone, rosuvastatin, senna alexandrina, sertraline hydrochloride, and tamsulosin hydrochloride. On an unspecified date, the patient experienced vomiting/throwing up stuff/violent vomiting once a week (has increased in intensity after he got his covid vaccine), (intensity: mild). On an unspecified date, the patient experienced difficulty thinking (intensity: mild), confusion (intensity: mild), and high blood sugars in 200s last A1c unremarkable at 6 point 2 percent (intensity: mild). Laboratory data (dates unspecified) included: Blood glucose was high. The action taken with covid-19 vaccine ad26.cov2.s was not applicable; and dose of enzalutamide was not changed. The patient had not recovered from difficulty thinking, vomiting/throwing up stuff/ violent vomiting once a week, confusion, and high blood sugars in 200s last a1c unremarkable at 6 point 2 percent. This report was serious (Other Medically Important Condition).; Sender's Comments: V0: 20230458974-difficulty thinking. The event has an unknown/unclear temporal relationship, is unlabeled, and has unknown scientific plausibility. There are other factors more likely to be associated with the event. Specifically: CONMEDS-OTHER SUSPECT DRUGS. Therefore, this event is considered inconsistent with vaccine administration.
Age: 71.0
Sex: F
Vaccine: VARZOS
Symptoms: Erythema, Injection site swelling, Pain, Pyrexia, Skin warm
Clinical narrative: patient reports having pain, swelling at injection site, redness, and hot to the touch. Patient also reports having a fever of 104.2
Age: 80.0
Sex: F
Vaccine: COVID19-2
Symptoms: COVID-19, Fatigue, Headache, Malaise, Oropharyngeal pain
Clinical narrative: I tested positive for Covid-19 on April 16, 2023 I experienced sore throat; congestion; headache; exhausted; I was prescribed Paxlovid for my symptoms.
Age: 80.0
Sex: F
Vaccine: COVID19-2
Symptoms: Respiratory tract congestion, SARS-CoV-2 test positive
Clinical narrative: I tested positive for Covid-19 on April 16, 2023 I experienced sore throat; congestion; headache; exhausted; I was prescribed Paxlovid for my symptoms.
Age: 74.0
Sex: M
Vaccine: COVID19-2
Symptoms: Unevaluable event
Clinical narrative: Vaccine was drawn up the day prior on 4/20/23 and was not wasted. By FDA guidelines, the Covid Bivalent Vaccine had expired within the 12 hours of being open on 4/20/23. The situation was discussed with patient and he elected to NOT have another Covid booster at this time.
Age: 45.0
Sex: F
Vaccine: COVID19
Symptoms: Antinuclear antibody positive, C-reactive protein normal, Erythema, Flushing, Rosacea
Clinical narrative: In December 2021 I noticed redness and flushing on my face.  It was worse after I drank hot beverages.  Specifically, it was on my cheeks and forehead.  It flares up every week or so.  I saw the doctor on March 24, 2023, and was diagnosed with rosacea.  I am also being evaluated for Lupas.  I was prescribed Doxycycline Monohydrate.
Age: 68.0
Sex: F
Vaccine: PPV
Symptoms: Erythema, Injection site erythema
Clinical narrative: Redness of injection site migrated from left lateral arm to medial arm and elbow.
Age: 15.0
Sex: M
Vaccine: HPV9, HPV9
Symptoms: Dizziness, Eye movement disorder, Hypoacusis, Immediate post-injection reaction, Unresponsive to stimuli
Clinical narrative: Patient was given his 1st dose of HPV vaccine. Immediately after injection, his eyes rolled back. He was not responding to mom and medical assistant as if he could not hear or see them.  He laid down but it took about 2 minutes for him to become aware of his surroundings again. After recovering he recounted that he started seeing white spots in his vision and his hearing was muffled.  He also felt dizzy. After water, candy and laying down for 15-20 minutes, he felt better and had no further issues.
Age: 15.0
Sex: M
Vaccine: HPV9, HPV9
Symptoms: Visual impairment
Clinical narrative: Patient was given his 1st dose of HPV vaccine. Immediately after injection, his eyes rolled back. He was not responding to mom and medical assistant as if he could not hear or see them.  He laid down but it took about 2 minutes for him to become aware of his surroundings again. After recovering he recounted that he started seeing white spots in his vision and his hearing was muffled.  He also felt dizzy. After water, candy and laying down for 15-20 minutes, he felt better and had no further issues.
Age: 15.0
Sex: M
Vaccine: HPV9, HPV9
Symptoms: Dizziness, Feeling abnormal, Hypoacusis, Immediate post-injection reaction, Visual impairment
Clinical narrative: Patient was given his 1st dose of HPV vaccine. Immediately after injection, his eyes rolled back. He was not responding to mom and medical assistant as if he could not hear or see them.  He laid down but it took about 2 minutes for him to become aware of his surroundings again. After recovering he recounted that he started seeing white spots in his vision and his hearing was muffled.  He also felt dizzy. After water, candy and laying down for 15-20 minutes, he felt better and had no further issues.
Age: 55.0
Sex: M
Vaccine: COVID19
Symptoms: COVID-19, Cough, Fatigue, Pyrexia, Respiratory tract congestion
Clinical narrative: Coughing, congestion, and fatigue on morning of 4/2/2023. Fever started next day. Three home covid tests; first two (4/2 and 4/3) were negative. Third (4/4) was positive.  (Note: I sang in a choir of ~120 people for the 3 days prior to developing symptoms. I know that at least 12 other singers also tested positive for Covid within 5 days of the same event.)
Age: 55.0
Sex: M
Vaccine: COVID19
Symptoms: SARS-CoV-2 test positive
Clinical narrative: Coughing, congestion, and fatigue on morning of 4/2/2023. Fever started next day. Three home covid tests; first two (4/2 and 4/3) were negative. Third (4/4) was positive.  (Note: I sang in a choir of ~120 people for the 3 days prior to developing symptoms. I know that at least 12 other singers also tested positive for Covid within 5 days of the same event.)
Age: 33.0
Sex: M
Vaccine: COVID19-2, VARCEL
Symptoms: Incorrect route of product administration
Clinical narrative: After giving pt L deltoid bivalent immunization, nurse moved over to R side  Repairing to give pt varicella vaccination on SQ, Right arm. Prior to administration, Pt asked nurse various questions regarding arm soreness. Nurse answered pt question and was distracted. Vaccination administered intramuscularly. In finishing documentation realized error. Reported to PL as soon as possible.
Age: 58.0
Sex: M
Vaccine: COVID19-2
Symptoms: Expired product administered, No adverse event, Product storage error
Clinical narrative: Vial was stored in fridge for more than 30 days; No adverse event; Patient was administered bivalent vaccine that had been in the fridge past 30 days; This spontaneous case was reported by a pharmacist and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Patient was administered bivalent vaccine that had been in the fridge past 30 days), PRODUCT STORAGE ERROR (Vial was stored in fridge for more than 30 days) and NO ADVERSE EVENT (No adverse event) in a 58-year-old male patient who received mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (batch no. AS7171B) for COVID-19 prophylaxis.     It was reported that patient had no known chronic or long standing health conditions.  Previously administered products included for Product used for unknown indication: COVID-19 VACCINE JANSSEN (1st dose) in May 2021. Past adverse reactions to the above products included No adverse event with COVID-19 VACCINE JANSSEN.    On 18-Apr-2023, the patient received third dose of mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (Intramuscular) .5 milliliter. On 18-Apr-2023, the patient experienced EXPIRED PRODUCT ADMINISTERED (Patient was administered bivalent vaccine that had been in the fridge past 30 days). On an unknown date, the patient experienced PRODUCT STORAGE ERROR (Vial was stored in fridge for more than 30 days) and NO ADVERSE EVENT (No adverse event). At the time of the report, EXPIRED PRODUCT ADMINISTERED (Patient was administered bivalent vaccine that had been in the fridge past 30 days), PRODUCT STORAGE ERROR (Vial was stored in fridge for more than 30 days) 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 EXPIRED PRODUCT ADMINISTERED (Patient was administered bivalent vaccine that had been in the fridge past 30 days) and PRODUCT STORAGE ERROR (Vial was stored in fridge for more than 30 days).    Concomitant medications were not reported.  The patient received second dose of Moderna COVID-19 vaccine in November 2021.  The dose details for suspect bivalent Moderna vaccine was reported as initial booster.  It was unknown if the first patient experienced any adverse events.  Treatment medications were not reported.   This case was linked to US-MODERNATX, INC.-MOD-2023-720479, US-MODERNATX, INC.-MOD-2023-720524 (E2B Linked Report).   Most recent FOLLOW-UP information incorporated above includes: On 27-Apr-2023: Significant follow up received; Patient demographics updated, vaccine administration date, dose details, route of administration and event onset date was updated.; Sender's Comments:  US-MODERNATX, INC.-MOD-2023-720479:same reporter US-MODERNATX, INC.-MOD-2023-720524:same reporter
Age: 72.0
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 13-Mar-2023 and was administered on 17-APR-2023; No adverse event; Administered expired Moderna Vaccine to patient after 30-day Use By Date; This spontaneous case was reported by a pharmacist and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Administered expired Moderna Vaccine to patient after 30-day Use By Date), PRODUCT STORAGE ERROR (The vial was initially stored in the refrigerator on 13-Mar-2023 and was administered on 17-APR-2023) and NO ADVERSE EVENT (No adverse event) in a 72-year-old female patient who received mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (batch no. 066H22A) for COVID-19 prophylaxis.     No Medical History information was reported.    On 17-Apr-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 17-Apr-2023, the patient experienced EXPIRED PRODUCT ADMINISTERED (Administered expired Moderna Vaccine to patient 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 13-Mar-2023 and was administered on 17-APR-2023) and NO ADVERSE EVENT (No adverse event). At the time of the report, EXPIRED PRODUCT ADMINISTERED (Administered expired Moderna Vaccine to patient after 30-day Use By Date), PRODUCT STORAGE ERROR (The vial was initially stored in the refrigerator on 13-Mar-2023 and was administered on 17-APR-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 (Administered expired Moderna Vaccine to patient after 30-day Use By Date) and PRODUCT STORAGE ERROR (The vial was initially stored in the refrigerator on 13-Mar-2023 and was administered on 17-APR-2023).    Concomitant medications were not reported.  It was unknown whether patient had received any other vaccines in the 4 weeks prior to COVID-19 vaccine. Pharmacist called to find out about the stability of expired Moderna Vaccines as it was administered to several patients after 30-day Use By Date.  The vial size was reported as 2.5 mL  The vial did not undergo had any temperature excursions. No treatment information was provided by the reporter.  This case contains information for the 4th of 11 patients described by the reporter.   This case was linked to US-MODERNATX, INC.-MOD-2023-721115 (E2B Linked Report).   Most recent FOLLOW-UP information incorporated above includes: On 25-Apr-2023: Live follow-up received with significant information. Patient details and suspect product administration date was added.; Sender's Comments:  US-MODERNATX, INC.-MOD-2023-721115:Patient 1
Age: 48.0
Sex: F
Vaccine: COVID19-2
Symptoms: Expired product administered, No adverse event, Product storage error
Clinical narrative: The vial was initially stored in refrigerator on 13Mar2023 and administered on 18-Apr-2023.; No adverse event; Administered expired Moderna Vaccine to patient after 30-day Use By Date; This spontaneous case was reported by a pharmacist and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Administered expired Moderna Vaccine to patient after 30-day Use By Date), PRODUCT STORAGE ERROR (The vial was initially stored in refrigerator on 13Mar2023 and administered on 18-Apr-2023.) and NO ADVERSE EVENT (No adverse event) in a 48-year-old female patient who received mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (batch no. 066H22A) for COVID-19 prophylaxis.     No Medical History information was reported.    On 18-Apr-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 18-Apr-2023, the patient experienced EXPIRED PRODUCT ADMINISTERED (Administered expired Moderna Vaccine to patient after 30-day Use By Date). On an unknown date, the patient experienced PRODUCT STORAGE ERROR (The vial was initially stored in refrigerator on 13Mar2023 and administered on 18-Apr-2023.) and NO ADVERSE EVENT (No adverse event). At the time of the report, EXPIRED PRODUCT ADMINISTERED (Administered expired Moderna Vaccine to patient after 30-day Use By Date), PRODUCT STORAGE ERROR (The vial was initially stored in refrigerator on 13Mar2023 and administered on 18-Apr-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 (Administered expired Moderna Vaccine to patient after 30-day Use By Date) and PRODUCT STORAGE ERROR (The vial was initially stored in refrigerator on 13Mar2023 and administered on 18-Apr-2023.).    No concomitant medications were reported. Patient was not breast feeding. It was unknown if the patient had received any other vaccine 4 weeks prior to COVID-19 vaccine. Pharmacist called to find out about the stability of expired Moderna Vaccines as it was administered to several patients after 30-day Use By Date. The vial size was 2.5 ml.  The vial did not undergo any temperature excursions. No treatment medications were reported. This case contains information for the 5th of 11 patients described by the reporter.   This case was linked to US-MODERNATX, INC.-MOD-2023-721115 (Linked Report).   Most recent FOLLOW-UP information incorporated above includes: On 25-Apr-2023: Live follow-up received with significant information. Patient details and suspect product details added.; Sender's Comments:  US-MODERNATX, INC.-MOD-2023-721115:
Age: 63.0
Sex: M
Vaccine: COVID19-2
Symptoms: Expired product administered, No adverse event, Product storage error
Clinical narrative: The vial was initially stored in refrigerator on 13Mar2023 and administered on 19-Apr-2023.; No adverse event; Administered expired Moderna Vaccine to the patient after 30-day Use By Date; This spontaneous case was reported by a pharmacist and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Administered expired Moderna Vaccine to the patient after 30-day Use By Date), PRODUCT STORAGE ERROR (The vial was initially stored in refrigerator on 13Mar2023 and administered on 19-Apr-2023.) 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. 066H22A) for COVID-19 prophylaxis.     No Medical History information was reported.    On 19-Apr-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 19-Apr-2023, the patient experienced EXPIRED PRODUCT ADMINISTERED (Administered expired Moderna Vaccine to the patient after 30-day Use By Date). On an unknown date, the patient experienced PRODUCT STORAGE ERROR (The vial was initially stored in refrigerator on 13Mar2023 and administered on 19-Apr-2023.) and NO ADVERSE EVENT (No adverse event). At the time of the report, EXPIRED PRODUCT ADMINISTERED (Administered expired Moderna Vaccine to the patient after 30-day Use By Date), PRODUCT STORAGE ERROR (The vial was initially stored in refrigerator on 13Mar2023 and administered on 19-Apr-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 (Administered expired Moderna Vaccine to the patient after 30-day Use By Date) and PRODUCT STORAGE ERROR (The vial was initially stored in refrigerator on 13Mar2023 and administered on 19-Apr-2023.).    No concomitant medications were reported. It was unknown if the patient had received any other vaccine 4 weeks prior to COVID-19 vaccine. Pharmacist called to find out about the stability of expired Moderna Vaccines as it was administered to several patients after 30-day Use By Date. The vial size was 2.5 ml.  The vial did not undergo any temperature excursions. No treatment medications were reported.  This case contains information for the 6th of 11 patients described by the reporter.   This case was linked to US-MODERNATX, INC.-MOD-2023-721115 (Linked Report).   Most recent FOLLOW-UP information incorporated above includes: On 25-Apr-2023: Live follow-up received with significant information. Patient details and suspect product details added.; Sender's Comments:  US-MODERNATX, INC.-MOD-2023-721115:
Age: 64.0
Sex: F
Vaccine: COVID19-2
Symptoms: Expired product administered, No adverse event, Product storage error
Clinical narrative: The vial was initially stored in refrigerator on 13Mar2023 and administered on 20-Apr-2023.; No adverse event; Administered expired Moderna Vaccine to patient after 30-day Use By Date; This spontaneous case was reported by a pharmacist and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Administered expired Moderna Vaccine to patient after 30-day Use By Date), PRODUCT STORAGE ERROR (The vial was initially stored in refrigerator on 13Mar2023 and administered on 20-Apr-2023.) and NO ADVERSE EVENT (No adverse event) in a 64-year-old female patient who received mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (batch no. 066H22A) for COVID-19 prophylaxis.     No Medical History information was reported.    On 20-Apr-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 20-Apr-2023, the patient experienced EXPIRED PRODUCT ADMINISTERED (Administered expired Moderna Vaccine to patient after 30-day Use By Date). On an unknown date, the patient experienced PRODUCT STORAGE ERROR (The vial was initially stored in refrigerator on 13Mar2023 and administered on 20-Apr-2023.) and NO ADVERSE EVENT (No adverse event). At the time of the report, EXPIRED PRODUCT ADMINISTERED (Administered expired Moderna Vaccine to patient after 30-day Use By Date), PRODUCT STORAGE ERROR (The vial was initially stored in refrigerator on 13Mar2023 and administered on 20-Apr-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 (Administered expired Moderna Vaccine to patient after 30-day Use By Date) and PRODUCT STORAGE ERROR (The vial was initially stored in refrigerator on 13Mar2023 and administered on 20-Apr-2023.).    No concomitant medications were reported. It was unknown if the patient had received any other vaccine 4 weeks prior to COVID-19 vaccine. Pharmacist called to find out about the stability of expired Moderna Vaccines as it was administered to several patients after 30-day Use By Date. The vial size was 2.5 ml.  The vial did not undergo any temperature excursions. No treatment medications were reported.  This case contains information for the 7th of 11 patients described by the reporter.   This case was linked to US-MODERNATX, INC.-MOD-2023-721115 (Linked Report).   Most recent FOLLOW-UP information incorporated above includes: On 25-Apr-2023: Live follow-up received with significant information. Patient details and suspect product details added.; Sender's Comments:  US-MODERNATX, INC.-MOD-2023-721115:Patient 1
Age: 76.0
Sex: M
Vaccine: COVID19-2
Symptoms: Expired product administered, No adverse event, Product storage error
Clinical narrative: The vial was initially stored in refrigerator on 13Mar2023 and administered on 20-Apr-2023.; No adverse event; Administered expired Moderna Vaccine to patient after 30-day Use By Date; This spontaneous case was reported by a pharmacist and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Administered expired Moderna Vaccine to patient after 30-day Use By Date), PRODUCT STORAGE ERROR (The vial was initially stored in refrigerator on 13Mar2023 and administered on 20-Apr-2023.) and NO ADVERSE EVENT (No adverse event) in a 76-year-old male patient who received mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (batch no. 066H22A) for COVID-19 prophylaxis.     No Medical History information was reported.    On 20-Apr-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 20-Apr-2023, the patient experienced EXPIRED PRODUCT ADMINISTERED (Administered expired Moderna Vaccine to patient after 30-day Use By Date). On an unknown date, the patient experienced PRODUCT STORAGE ERROR (The vial was initially stored in refrigerator on 13Mar2023 and administered on 20-Apr-2023.) and NO ADVERSE EVENT (No adverse event). At the time of the report, EXPIRED PRODUCT ADMINISTERED (Administered expired Moderna Vaccine to patient after 30-day Use By Date), PRODUCT STORAGE ERROR (The vial was initially stored in refrigerator on 13Mar2023 and administered on 20-Apr-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 (Administered expired Moderna Vaccine to patient after 30-day Use By Date) and PRODUCT STORAGE ERROR (The vial was initially stored in refrigerator on 13Mar2023 and administered on 20-Apr-2023.).    No concomitant medications were reported. It was unknown if the patient had received any other vaccine 4 weeks prior to COVID-19 vaccine. Pharmacist called to find out about the stability of expired Moderna Vaccines as it was administered to several patients after 30-day Use By Date. The vial size was 2.5 ml.  The vial did not undergo any temperature excursions. No treatment medications were reported.  This case contains information for the 8th of 11 patients described by the reporter.   This case was linked to US-MODERNATX, INC.-MOD-2023-721115 (E2B Linked Report).   Most recent FOLLOW-UP information incorporated above includes: On 25-Apr-2023: Live follow-up received with significant information. Patient details and suspect product details added.; Sender's Comments:  US-MODERNATX, INC.-MOD-2023-721115:
Age: 68.0
Sex: M
Vaccine: COVID19-2
Symptoms: Expired product administered, No adverse event, Product storage error
Clinical narrative: The vial was initially stored in refrigerator on 13Mar2023 and administered on 20-Apr-2023; No adverse event; Administered expired Moderna Vaccine to patient after 30-day Use By Date; This spontaneous case was reported by a pharmacist and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Administered expired Moderna Vaccine to patient after 30-day Use By Date), PRODUCT STORAGE ERROR (The vial was initially stored in refrigerator on 13Mar2023 and administered on 20-Apr-2023) and NO ADVERSE EVENT (No adverse event) in a 68-year-old male patient who received mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (batch no. 066H22A) for COVID-19 prophylaxis.     No Medical History information was reported.    On 20-Apr-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 20-Apr-2023, the patient experienced EXPIRED PRODUCT ADMINISTERED (Administered expired Moderna Vaccine to patient after 30-day Use By Date). On an unknown date, the patient experienced PRODUCT STORAGE ERROR (The vial was initially stored in refrigerator on 13Mar2023 and administered on 20-Apr-2023) and NO ADVERSE EVENT (No adverse event). At the time of the report, EXPIRED PRODUCT ADMINISTERED (Administered expired Moderna Vaccine to patient after 30-day Use By Date), PRODUCT STORAGE ERROR (The vial was initially stored in refrigerator on 13Mar2023 and administered on 20-Apr-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 (Administered expired Moderna Vaccine to patient after 30-day Use By Date) and PRODUCT STORAGE ERROR (The vial was initially stored in refrigerator on 13Mar2023 and administered on 20-Apr-2023).    No concomitant medications were reported. It was unknown if the patient had received any other vaccine 4 weeks prior to COVID-19 vaccine. Pharmacist called to find out about the stability of expired Moderna Vaccines as it was administered to several patients after 30-day Use By Date. The vial size was 2.5 ml.  The vial did not undergo any temperature excursions. No treatment medications were reported.  This case contains information for the 9th of 11 patients described by the reporter.   This case was linked to US-MODERNATX, INC.-MOD-2023-721115 (Linked Report).   Most recent FOLLOW-UP information incorporated above includes: On 25-Apr-2023: Live follow-up received with significant information. Patient details and suspect product administration date was added.; Sender's Comments:  US-MODERNATX, INC.-MOD-2023-721115:Patient 1
Sex: F
Vaccine: COVID19
Symptoms: Human papilloma virus test, Maternal exposure during pregnancy, Papilloma viral infection
Clinical narrative: Maternal exposure during pregnancy; Other high risk HPV genotype pool positive; This spontaneous prospective pregnancy case was reported by a patient and describes the occurrence of PAPILLOMA VIRAL INFECTION (Other high risk HPV genotype pool positive) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 prophylaxis. The occurrence of additional non-serious events is detailed below.   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. Last menstrual period and estimated date of delivery were not provided. On 13-Jul-2021, the patient experienced PAPILLOMA VIRAL INFECTION (Other high risk HPV genotype pool positive) (seriousness criterion medically significant). On an unknown date, the patient experienced MATERNAL EXPOSURE DURING PREGNANCY (Maternal exposure during pregnancy). At the time of the report, PAPILLOMA VIRAL INFECTION (Other high risk HPV genotype pool positive) had not resolved and MATERNAL EXPOSURE DURING PREGNANCY (Maternal exposure during pregnancy) had resolved.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 13-Jul-2021, Human papilloma virus test: Positive.  The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.  Concomitant and treatment medications were not provided.  Degree of severity for the event was reported as Grade 1: Mild, asymptomatic or mild symptoms, clinical or diagnostic observations only, no intervention indicated.  Summary of the event was reported as Cervix: acetowhite lesions noted at 9 o'clock, no biopsies taken.  Company comment: This spontaneous case concerns a pregnant female patient of unknown age, with no reported medical history, who experienced the unexpected serious (medically significant) event of Papilloma viral infection which occurred unknown days after administration of a dose of mRNA-1273 vaccine. Acetowhite lesions were noted at cervix 9 o'clock. Biopsy was not taken. Event was ongoing at the time of report. The benefit-risk relationship of mRNA-1273 vaccine is not affected by this report.   Reporter did not allow further contact; Reporter's Comments: Company comment: This spontaneous case concerns a pregnant female patient of unknown age, with no reported medical history, who experienced the unexpected serious (medically significant) event of Papilloma viral infection which occurred unknown days after administration of a dose of mRNA-1273 vaccine. Acetowhite lesions were noted at cervix 9 o'clock. Biopsy was not taken. Event was ongoing at the time of report. The benefit-risk relationship of mRNA-1273 vaccine is not affected by this report.
Age: 65.0
Sex: F
Vaccine: PNC20
Symptoms: Incorrect dose administered, Syringe issue
Clinical narrative: The "defect," per the employee was noted while injecting into the patient. Most of the vaccine leaked out of the syringe and was not given to the patient. We are unsure how much vaccine the patient actually received.
Age: 65.0
Sex: F
Vaccine: VARZOS
Symptoms: Constipation, Fall, Gait inability, Pain in extremity, Paralysis
Clinical narrative: 7 hrs later I went down to the ground. I tried getting up but i couldn't get up. My body was paraylzed. 12 hrs later my friend got me out of the chair. I couldn't walk my legs were in pain. I wasn't able to move. 4 days i had no bowel movements.
Age: 71.0
Sex: F
Vaccine: PNC20
Symptoms: Dyspnoea, Injection site erythema
Clinical narrative: Patient presented to Nurse Triage with concerns due to redness surrounding Pneumo Conjugate injection site received on 04/24/2023. No complaints of pain or itching. Patient presented with no difficulty breathing and has no prior history of allergic reaction to vaccines. Patient was seen by on-site physician Dr. and RN. No bleeding, discharge, ulceration, or infection noted by physician, Dr.
Age: 51.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Amyotrophic lateral sclerosis, Dysarthria, Electromyogram abnormal, Laboratory test abnormal
Clinical narrative: 3/11/22 Slurred speech 1/26/23 ALS diagnosis
Age: 83.0
Sex: M
Vaccine: COVID19
Symptoms: COVID-19, SARS-CoV-2 test positive
Clinical narrative: Contracted COVID on 16 April 2023
Age: 72.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site warmth, Pain in extremity
Clinical narrative: Per patient, she has a sore arm and feeling hot around the injection site
Age: 52.0
Sex: F
Vaccine: COVID19, COVID19, COVID19
Symptoms: Tinnitus
Clinical narrative: Developed tinnitus after the Moderna vaccine
Age: 70.0
Sex: F
Vaccine: COVID19
Symptoms: Cardiac stress test, Dizziness, Electrocardiogram ambulatory, Heart rate increased, Hypotension
Clinical narrative: LIGHT HEADED LOW BLOOD PRESSURE 86/56 HIGH PULSE RATE 144