chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 21.0
Sex: M
Vaccine: TYP
Symptoms: Urticaria
Clinical narrative: Hives; A spontaneous report was received from a physician assistant on 19MAY2023 regarding a 22-year-old male patient who had "hives" (PT: Urticaria) following the administration of Vivotif (Typhoid vaccine live oral Ty21A; lot number: unknown) as an immunisation.  The patient's medical history, concomitant medications, or known allergies were not reported.  On 10MAY2023, the patient received the third dose of Vivotif following which he experienced hives. Reportedly, the patient was advised to see immediate medical help, and not to administer the fourth dose of Vivotif.  The outcome of the reported event was unknown, at the time of this report.  The action taken with Vivotif with respect to the reported event was withdrawn.  No additional information was reported.  Company comment: A consumer took Vivotif for immunisation and developed hives (urticaria). Further information regarding the event is limited. Considering the case information, the role of Vivotif cannot be ruled out and the causality of urticaria is assessed as possible. The case is considered non serious as per medical assessment.; Sender's Comments: A consumer took Vivotif for immunisation and developed hives (urticaria). Further information regarding the event is limited. Considering the case information, the role of Vivotif cannot be ruled out and the causality of urticaria is assessed as possible. The case is considered non serious as per medical assessment.
Age: 54.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site erythema
Clinical narrative: Patient has redness at and below injection site
Age: 5.0
Sex: M
Vaccine: COVID19-2
Symptoms: No adverse event, Underdose, Wrong product administered
Clinical narrative: Wrong bivalent was given. He was given the 0.2ml volume (yellow label) instead of the 0.25ml (gray label) Moderna bivalent. MD was made aware. Pt with no signs of symptoms of adverse reaction. Pt was discharged home in stable condition.
Age: 1.0
Sex: F
Vaccine: HEPA, MMRV, PNC13, VARCEL
Symptoms: Extra dose administered, Injection site erythema, Injection site swelling, Irritability
Clinical narrative: Patient received combination MMRV instead of MMR and was also given stand-alone varicella, resulting in double dose of varicella being administered. Mom states patient seemed to be more irritable than usual after vaccine administration, and the injection site was redder and more swollen than with other vaccines previously administered. Mom did not feel the need to initiate follow up care based on patient reaction and side effects resolved on their own.
Sex: U
Vaccine: TYP
Symptoms: Urinary tract infection
Clinical narrative: Acute urinary tract infection; A spontaneous report was received from a physician on 14JUN2023 regarding a patient of unknown age and gender who had an "acute urinary tract infection" (PT: Urinary tract infection) during the administration of Vivotif capsules (typhoid vaccine live oral Ty21A; lot number: unknown) for immunisation.  The patient's medical history, concomitant medications, or known allergies were not reported.  It was reported that the patient was having an acute urinary tract infection while on therapy with Vivotif.  The outcome of the reported event was unknown, at the time of this report.  The action taken with Vivotif with respect to the reported event was unknown.  No additional information was reported.  Company comment: It was reported that a consumer has an acute urinary tract infection (urinary tract infection) during the course of administration of Vivotif. Further information regarding event is limited. Based on unclear information regarding the temporality with Vivotif, the causality of urinary tract infection is assessed as unlikely with Vivotif. The case is considered non serious as per medical assessment.; Sender's Comments: It was reported that a consumer has an acute urinary tract infection (urinary tract infection) during the course of administration of Vivotif. Further information regarding event is limited. Based on unclear information regarding the temporality with Vivotif, the causality of urinary tract infection is assessed as unlikely with Vivotif. The case is considered non serious as per medical assessment.
Sex: U
Vaccine: VARZOS
Symptoms: Herpes zoster, Vaccination failure
Clinical narrative: Suspected vaccination failure; I got my shot and still got shingles; This serious case was reported by a consumer via interactive digital media and described the occurrence of vaccination failure in a patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   On an unknown date, the patient received Shingles vaccine. On an unknown date, an unknown time after receiving Shingles vaccine, the patient experienced vaccination failure (Verbatim: Suspected vaccination failure) (serious criteria GSK medically significant) and shingles (Verbatim: I got my shot and still got shingles). The outcome of the vaccination failure was unknown and the outcome of the shingles was not reported.   It was unknown if the reporter considered the vaccination failure and shingles to be related to Shingles vaccine.     It was unknown if the company considered the vaccination failure and shingles to be related to Shingles vaccine.   Additional Information: GSK receipt date: 23-JUN-2023 The case was received from the patient interactive digital media. The patient got shot and still got shingles. This case was considered as suspected vaccination failure as details regarding completion of primary vaccination schedule, time to onset for shingles and laboratory confirmation regarding shingles were unknown at the time of reporting. The follow-up could not be possible as no contact details were available.
Age: 60.0
Sex: U
Vaccine: VARZOS
Symptoms: Herpes zoster, Vaccination failure
Clinical narrative: Suspected vaccination failure; chronic break outs. About every 2 months I break out; This serious case was reported by a consumer via interactive digital media and described the occurrence of vaccination failure in a 60-year-old patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   The patient's past medical history included shingles (the patient got shingles at 59 years old for the first time).   On an unknown date, the patient received Shingles vaccine. On an unknown date, an unknown time after receiving Shingles vaccine, the patient experienced vaccination failure (Verbatim: Suspected vaccination failure) (serious criteria GSK medically significant) and shingles (Verbatim: chronic break outs. About every 2 months I break out). The patient was treated with antibiotics nos (Antibiotics Therapy (Unknown)). The outcome of the vaccination failure was unknown and the outcome of the shingles was not resolved.   It was unknown if the reporter considered the vaccination failure and shingles to be related to Shingles vaccine.     It was unknown if the company considered the vaccination failure and shingles to be related to Shingles vaccine.   Additional Information: GSK Receipt Date: 25-JUN-2023 The patient self-reported this case. This case was reported by a patient via interactive digital media. The patient received Shingrix vaccine at 60 and now patient had chronic break outs, about every 2 months it break out. The patient took a viral antibiotic that kept on hand for it. This case was considered as suspected vaccination failure as details regarding completion of primary schedule, time to onset for shingles and laboratory confirmation regarding shingles were unknown at the time of reporting.
Sex: F
Vaccine: VARZOS
Symptoms: Rash
Clinical narrative: Intense lower extremity rash; This non-serious case was reported by a consumer and described the occurrence of rash in a 77-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   Concurrent medical conditions included hypothyroidism. Concomitant products included levothyroxine.   On an unknown date, the patient received Shingrix. On an unknown date, an unknown time after receiving Shingrix, the patient experienced rash (Verbatim: Intense lower extremity rash). The outcome of the rash was resolved.   It was unknown if the reporter considered the rash to be related to Shingrix.     It was unknown if the company considered the rash to be related to Shingrix.   Additional Information: GSK Receipt Date: 24-JUN-2023. This report was submitted. This report was submitted via the online direct entry reporting system. Please process using the related SOP. This report was submitted by site public reporting. The patient was not pregnant. The patient was the reporter. Reporter seriousness for Intense lower extremity rash was intervention required The reporter consented to follow up.
Sex: U
Vaccine: VARZOS
Symptoms: Injection site mass
Clinical narrative: big lump at the injection site; This non-serious case was reported by a consumer via interactive digital media and described the occurrence of injection site lump in a patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   On an unknown date, the patient received Shingles vaccine. On an unknown date, an unknown time after receiving Shingles vaccine, the patient experienced injection site lump (Verbatim: big lump at the injection site). The action taken with Shingles vaccine was unknown. The outcome of the injection site lump was unknown.   It was unknown if the reporter considered the injection site lump to be related to Shingles vaccine.     It was unknown if the company considered the injection site lump to be related to Shingles vaccine.   Additional Information: Additional Information: GSK Receipt date:19-JUN-2023 This case was reported by a consumer via interactive digital media. Omg got round one the other day because my mom presented with by her eye. She's on the mend and patient have a big lump at the injection site.
Sex: M
Vaccine: VARZOS
Symptoms: Illness, Pain, Urticaria
Clinical narrative: he got weals; Pain; fell very ill; This non-serious case was reported by a consumer via interactive digital media and described the occurrence of wheals in a male patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   On an unknown date, the patient received Shingles vaccine. On an unknown date, an unknown time after receiving Shingles vaccine, the patient experienced wheals (Verbatim: he got weals), pain (Verbatim: Pain) and illness (Verbatim: fell very ill). The outcome of the wheals, pain and illness were not reported.   It was unknown if the reporter considered the wheals, pain and illness to be related to Shingles vaccine.     It was unknown if the company considered the wheals, pain and illness to be related to Shingles vaccine.   Additional Information: GSK receipt date: 22-JUN-2023 The case was received from the consumer interactive digital media. The reporter stated that someone told him/her that he had been at the hospital and that he had been given the vaccine and that he fell very ill, he got wheals and that the pain was unbearable and in fact he told that reporter should never get this vaccine done, that's why reporter had the doubt.   The follow-up could not be possible as no contact details were available.
Sex: U
Vaccine: VARZOS
Symptoms: Feeling abnormal, Pain in extremity
Clinical narrative: Arm was so sore; Never reacted so poorly to any shot in my life; This non-serious case was reported by a consumer via interactive digital media and described the occurrence of pain in arm in a patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   On 20-JUN-2023, the patient received the 2nd dose of Shingles vaccine. In JUN-2023, an unknown time after receiving Shingles vaccine, the patient experienced pain in arm (Verbatim: Arm was so sore) and feels poorly (Verbatim: Never reacted so poorly to any shot in my life). The outcome of the pain in arm and feels poorly were not reported.   It was unknown if the reporter considered the pain in arm and feels poorly to be related to Shingles vaccine.     It was unknown if the company considered the pain in arm and feels poorly to be related to Shingles vaccine.   Additional Information: GSK Receipt Date: 23-Jun-23 This case was reported by a patient via interactive digital media. The patient stated she/he just had my second shot Tuesday, and his/her arm was so sore.  Patient reported that she/he never reacted so poorly to any shot in his/her life.
Sex: F
Vaccine: VARZOS
Symptoms: Atrioventricular block complete, Bundle branch block left, Cardiac pacemaker insertion, Catheterisation cardiac abnormal, Dyspnoea
Clinical narrative: Fatigue; Shortness of breath; Complete heart block; Bigeminal pre ventricular contractions (PVC's); Torsades de pointes; Left bundle branch block; This serious case was reported by a nurse via call center representative and described the occurrence of fatigue in a 65-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   On an unknown date, the patient received Shingrix. On an unknown date, 3 weeks after receiving Shingrix, the patient experienced fatigue (Verbatim: Fatigue) (serious criteria hospitalization and clinically significant/intervention required), shortness of breath (Verbatim: Shortness of breath) (serious criteria hospitalization and clinically significant/intervention required), complete heart block (Verbatim: Complete heart block) (serious criteria hospitalization, GSK medically significant and clinically significant/intervention required), bigeminal rhythm (Verbatim: Bigeminal pre ventricular contractions (PVC's)) (serious criteria hospitalization and clinically significant/intervention required), torsade de pointes (Verbatim: Torsades de pointes) (serious criteria hospitalization, GSK medically significant and clinically significant/intervention required) and left bundle branch block (Verbatim: Left bundle branch block) (serious criteria hospitalization and clinically significant/intervention required). The outcome of the fatigue, shortness of breath, bigeminal rhythm and torsade de pointes were resolved and the outcome of the complete heart block was unknown and the outcome of the left bundle branch block was not resolved.   It was unknown if the reporter considered the fatigue, shortness of breath, complete heart block, bigeminal rhythm, torsade de pointes and left bundle branch block to be related to Shingrix.  It was unknown if the company considered the fatigue, shortness of breath, complete heart block, bigeminal rhythm, torsade de pointes and left bundle branch block to be related to Shingrix.   Additional Information: GSK Receipt Date: 22-JUN-2023 The reporter reported that a patient received a dose of Shingrix (unknown if it was the 1st or 2nd dose) and she came in 3 weeks after the vaccine was administered presented with fatigue and shortness of breath and was found to have a complete heart block, bigeminal PVC's and torsades de pointe. The patient was admitted and had a heart catheterization done on 29Apr2023. The patient had a pacemaker implanted on 01May2023. The reporter reported that at time of reporting left Bundle Branch Block persists, but PVC's have resolved. Follow up ok via Health Care Provider email in HCP details, vaccine was given by patient's primary care physician so no details about lot, expiry etc were available but HCP said she may be able to get some details for follow up report. The reporter did consent to follow up.
Sex: F
Vaccine: VARZOS
Symptoms: Extrasystoles, Fatigue, Ventricular extrasystoles
Clinical narrative: Fatigue; Shortness of breath; Complete heart block; Bigeminal pre ventricular contractions (PVC's); Torsades de pointes; Left bundle branch block; This serious case was reported by a nurse via call center representative and described the occurrence of fatigue in a 65-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   On an unknown date, the patient received Shingrix. On an unknown date, 3 weeks after receiving Shingrix, the patient experienced fatigue (Verbatim: Fatigue) (serious criteria hospitalization and clinically significant/intervention required), shortness of breath (Verbatim: Shortness of breath) (serious criteria hospitalization and clinically significant/intervention required), complete heart block (Verbatim: Complete heart block) (serious criteria hospitalization, GSK medically significant and clinically significant/intervention required), bigeminal rhythm (Verbatim: Bigeminal pre ventricular contractions (PVC's)) (serious criteria hospitalization and clinically significant/intervention required), torsade de pointes (Verbatim: Torsades de pointes) (serious criteria hospitalization, GSK medically significant and clinically significant/intervention required) and left bundle branch block (Verbatim: Left bundle branch block) (serious criteria hospitalization and clinically significant/intervention required). The outcome of the fatigue, shortness of breath, bigeminal rhythm and torsade de pointes were resolved and the outcome of the complete heart block was unknown and the outcome of the left bundle branch block was not resolved.   It was unknown if the reporter considered the fatigue, shortness of breath, complete heart block, bigeminal rhythm, torsade de pointes and left bundle branch block to be related to Shingrix.  It was unknown if the company considered the fatigue, shortness of breath, complete heart block, bigeminal rhythm, torsade de pointes and left bundle branch block to be related to Shingrix.   Additional Information: GSK Receipt Date: 22-JUN-2023 The reporter reported that a patient received a dose of Shingrix (unknown if it was the 1st or 2nd dose) and she came in 3 weeks after the vaccine was administered presented with fatigue and shortness of breath and was found to have a complete heart block, bigeminal PVC's and torsades de pointe. The patient was admitted and had a heart catheterization done on 29Apr2023. The patient had a pacemaker implanted on 01May2023. The reporter reported that at time of reporting left Bundle Branch Block persists, but PVC's have resolved. Follow up ok via Health Care Provider email in HCP details, vaccine was given by patient's primary care physician so no details about lot, expiry etc were available but HCP said she may be able to get some details for follow up report. The reporter did consent to follow up.
Sex: F
Vaccine: MNQ
Symptoms: Incorrect dose administered, Product preparation issue
Clinical narrative: administered only the liquid component of Menveo; Inappropriate dose of vaccine administered; This non-serious case was reported by a pharmacist via call center representative and described the occurrence of inappropriate preparation of medication in a adult female patient who received Men ACWY-CRM NVS (Menveo) for prophylaxis.   On 22-JUN-2023, the patient received Menveo. On 22-JUN-2023, an unknown time after receiving Menveo, the patient experienced inappropriate preparation of medication (Verbatim: administered only the liquid component of Menveo) and inappropriate dose of vaccine administered (Verbatim: Inappropriate dose of vaccine administered). The outcome of the inappropriate preparation of medication and inappropriate dose of vaccine administered were unknown.   Additional Information: GSK Receipt Date: 23-JUN-2023 The pharmacist reported that a patient was administered only the liquid component of Menveo, which led to inappropriate preparation of medication and inappropriate dose of vaccine administered. The reporter consented to follow up. The healthcare professional was unsure if the age of the patient was 18 or 19 years.
Age: 63.0
Sex: F
Vaccine: VARZOS
Symptoms: Neuralgia, Pain, Pain in extremity
Clinical narrative: pain in the finger; nerve pain radiating in the arm and opposite leg.; feeling pain/ general pain; This non-serious case was reported by a pharmacist via call center representative and described the occurrence of pain in fingers in a 63-year-old female patient who received Herpes zoster (Shingrix) (batch number D734X, expiry date 28-MAY-2024) for prophylaxis.   On 21-MAR-2023, the patient received the 1st dose of Shingrix. In JUN-2023, 3 months after receiving Shingrix, the patient experienced pain in fingers (Verbatim: pain in the finger), nerve pain (Verbatim: nerve pain radiating in the arm and opposite leg.) and general body pain (Verbatim: feeling pain/ general pain). The outcome of the pain in fingers, nerve pain and general body pain were unknown.   It was unknown if the reporter considered the pain in fingers, nerve pain and general body pain to be related to Shingrix.     It was unknown if the company considered the pain in fingers, nerve pain and general body pain to be related to Shingrix.   Additional Information: GSK Receipt Date: 26-JUN-2023. The pharmacist called to inform that 3 months after the 1st dose of Shingrix, a patient reported feeling pain, pain in the finger, and nerve pain radiating in the arm and opposite leg. The vaccine administration facility was the same as Primary Reporter. The reporter consented to follow up.
Age: 4.0
Sex: M
Vaccine: DTAPIPV
Symptoms: Expired product administered
Clinical narrative: a dose of Kinrix that had already expired back in 7/May/2023 was inadvertently administered to a patient; This non-serious case was reported by a other health professional via call center representative and described the occurrence of expired vaccine used in a 4-year-old male patient who received DTPa-IPV (Kinrix) (batch number H9FM5, expiry date 07-MAY-2023) for prophylaxis.   On 15-MAY-2023, the patient received Kinrix. On 15-MAY-2023, an unknown time after receiving Kinrix, the patient experienced expired vaccine used (Verbatim: a dose of Kinrix that had already expired back in 7/May/2023 was inadvertently administered to a patient). The outcome of the expired vaccine used was unknown.   This report is made by GSK without prejudice and does not imply any admission or liability for the incident or its consequences.   Additional Information: GSK receipt date: 27-Jun-2023 The vaccine administration facility was the same as primary reporter. The reporter consented to follow-up. The patient received an expired dose of Kinrix, which led to expired vaccine used.
Age: 18.0
Sex: F
Vaccine: COVID19
Symptoms: Inappropriate schedule of product administration, No adverse event
Clinical narrative: No adverse event; 1st dose was administered 24-Jun-2021 and 2nd dose was administered 16-Jul-2021; This spontaneous case was reported by an other health care professional and describes the occurrence of INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (1st dose was administered 24-Jun-2021 and 2nd dose was administered 16-Jul-2021) and NO ADVERSE EVENT (No adverse event) in an 18-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 prophylaxis.     No Medical History information was reported.   On 24-Jun-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 16-Jul-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 16-Jul-2021, the patient experienced INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (1st dose was administered 24-Jun-2021 and 2nd dose was administered 16-Jul-2021). On an unknown date, the patient experienced NO ADVERSE EVENT (No adverse event). At the time of the report, INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (1st dose was administered 24-Jun-2021 and 2nd dose was administered 16-Jul-2021) and NO ADVERSE EVENT (No adverse event) outcome was unknown. Not Provided      For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter considered NO ADVERSE EVENT (No adverse event) to be not related. No further causality assessment was provided for INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (1st dose was administered 24-Jun-2021 and 2nd dose was administered 16-Jul-2021).    No concomitant medication was reported.  No treatment information was reported.      This case was linked to MOD-2023-730156 (Patient Link).
Sex: U
Vaccine: COVID19-2
Symptoms: Expired product administered, No adverse event
Clinical narrative: No adverse event; Our medical organization administered a Moderna Bivalent vaccine that was 2 days past expiration; This spontaneous case was reported by an other health care professional and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Our medical organization administered a Moderna Bivalent vaccine that was 2 days past expiration) and NO ADVERSE EVENT (No adverse event) in a  patient of an unknown age and gender who received mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (batch no. 065H22A) for COVID-19 prophylaxis.     No Medical History information was reported.    On 15-Jun-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 15-Jun-2023, the patient experienced EXPIRED PRODUCT ADMINISTERED (Our medical organization administered a Moderna Bivalent vaccine that was 2 days past expiration). On an unknown date, the patient experienced NO ADVERSE EVENT (No adverse event). At the time of the report, EXPIRED PRODUCT ADMINISTERED (Our medical organization administered a Moderna Bivalent vaccine that was 2 days past expiration) 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 EXPIRED PRODUCT ADMINISTERED (Our medical organization administered a Moderna Bivalent vaccine that was 2 days past expiration).    This case contains information for the 2nd of 2 patients described by the reporter.  No concomitant drug was reported.  It was unknown if patient received any other vaccines in the 4 weeks prior to COVID-19 vaccine.  Patient had been administered a Moderna Bivalent vaccine that was 2 days past expiration.  The vial was un-punctured and was in the freezer until the day it was administered.  No prior temperature excursion.  No treatment drug was reported.   This case was linked to US-MODERNATX, INC.-MOD-2023-730343 (E2B Linked Report).   Reporter did not allow further contact; Sender's Comments:  US-MODERNATX, INC.-MOD-2023-730343:Patient 1
Age: 72.0
Sex: F
Vaccine: COVID19-2
Symptoms: Expired product administered, No adverse event
Clinical narrative: No adverse event; Dose administered after manufacturer date of expiry; This spontaneous case was reported by an other health care professional and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Dose administered after manufacturer date of expiry) 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 nos. 042H22A and 053D22A) for COVID-19 prophylaxis.     Previously administered products included for COVID-19 prophylaxis: Moderna COVID-19 Vaccine (Dose 1) on 04-Mar-2021, Moderna COVID-19 Vaccine (Dose 2) on 24-Mar-2021, Moderna COVID-19 Vaccine (Dose 3) on 19-Nov-2021 and Moderna COVID-19 Vaccine (Dose 4) on 04-May-2022. Past adverse reactions to the above products included No adverse event with Moderna COVID-19 Vaccine, Moderna COVID-19 Vaccine, Moderna COVID-19 Vaccine and Moderna COVID-19 Vaccine. Concurrent medical conditions included Hypertension.   On 03-Nov-2022, the patient received fifth dose of mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (unknown route) 1 dosage form. On 09-Jun-2023, received sixth dose of mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (unknown route) dosage was changed to .5 milliliter. On 09-Jun-2023, the patient experienced EXPIRED PRODUCT ADMINISTERED (Dose administered after manufacturer date of expiry). On an unknown date, the patient experienced NO ADVERSE EVENT (No adverse event). At the time of the report, EXPIRED PRODUCT ADMINISTERED (Dose administered after manufacturer date of expiry) 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 EXPIRED PRODUCT ADMINISTERED (Dose administered after manufacturer date of expiry).    Patient did not received any other vaccines in the 4 weeks prior to COVID-19 vaccine. Concomitant medication details not reported by the reporter. Treatment details was not reported by the reporter.   This case was linked to MOD-2023-730794 (Patient Link).
Sex: U
Vaccine: COVID19-2
Symptoms: Expired product administered, No adverse event
Clinical narrative: No adverse event; patient was administered a Moderna Bivalent vaccine that was 2 days past expiration.; This spontaneous case was reported by an other health care professional and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (patient was administered a Moderna Bivalent vaccine that was 2 days past expiration.) and NO ADVERSE EVENT (No adverse event) in a  patient of an unknown age and gender who received mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (batch no. 065H22A) for COVID-19 prophylaxis.     No Medical History information was reported.    On 15-Jun-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 15-Jun-2023,  after starting mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)), the patient experienced EXPIRED PRODUCT ADMINISTERED (patient was administered a Moderna Bivalent vaccine that was 2 days past expiration.). On an unknown date, the patient experienced NO ADVERSE EVENT (No adverse event). At the time of the report, EXPIRED PRODUCT ADMINISTERED (patient was administered a Moderna Bivalent vaccine that was 2 days past expiration.) 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 EXPIRED PRODUCT ADMINISTERED (patient was administered a Moderna Bivalent vaccine that was 2 days past expiration.).    Patient received any other vaccines in the 4 weeks prior to COVID-19 vaccine were unknown. Concomitant medication details not reported by the reporter. Vial was un-punctured and was in the freezer until the day it was administered. No prior temperature excursion occurred. Treatment details was not reported by the reporter.   This case was linked to US-MODERNATX, INC.-MOD-2023-730842 (E2B Linked Report).   Reporter did not allow further contact; Sender's Comments:  US-MODERNATX, INC.-MOD-2023-730842:Patient 2
Sex: F
Vaccine: COVID19
Symptoms: Vaccination site pain
Clinical narrative: she had pain in her upper left arm after the second Moderna Covid-19 vaccine.; This spontaneous case was reported by a patient and describes the occurrence of VACCINATION SITE PAIN (she had pain in her upper left arm after the second Moderna Covid-19 vaccine.) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 016B21A and 023M20A) for COVID-19 prophylaxis.     No Medical History information was reported.   On 05-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 02-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. In April 2021, the patient experienced VACCINATION SITE PAIN (she had pain in her upper left arm after the second Moderna Covid-19 vaccine.). At the time of the report, VACCINATION SITE PAIN (she had pain in her upper left arm after the second Moderna Covid-19 vaccine.) had not resolved.            The patient received her first Moderna Covid-19 booster vaccine on 2 Apr 2022 lot number 039F241, expiration date was not known. Patient received the vaccine in her left arm. Patient reports no adverse reactions or side effects.   The patient received a Moderna Covid-19 vaccine booster dose on 27 May 2022 lot number 054A22A expiration date was not known. Patient received the vaccine in her left arm. The chills started sometime before October 2022 but not know when.  The patient received her last booster dose on 15 Oct 2022. This vaccine was a Pfizer vaccine. Patient had a flu vaccine at the time of Pfizer vaccine.  Treatment medication not reported.   This case was linked to US-MODERNATX, INC.-MOD-2023-730787 (E2B Linked Report).   Reporter did not allow further contact; Sender's Comments:  US-MODERNATX, INC.-MOD-2023-730787:Same patient, different dose
Age: 47.0
Sex: U
Vaccine: COVID19-2
Symptoms: Expired product administered, No adverse event, Product storage error, Wrong product administered
Clinical narrative: Vaccines administered after being in stored in fridge past 30 days; Patient that received first dose of primary series of Moderna Bivalent vaccine; Vaccines administered beyound 30-day use by date; no adverse event; This spontaneous case was reported by an other health care professional and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Vaccines administered after being in stored in fridge past 30 days), WRONG PRODUCT ADMINISTERED (Patient that received first dose of primary series of Moderna Bivalent vaccine), PRODUCT STORAGE ERROR (Vaccines administered beyound 30-day use by date) and NO ADVERSE EVENT (no adverse event) in a 47-year-old patient of an unknown gender who received mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (batch no. AS7185B) for COVID-19 prophylaxis.     No Medical History information was reported.    On an unknown date, the patient received first 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 EXPIRED PRODUCT ADMINISTERED (Vaccines administered after being in stored in fridge past 30 days), WRONG PRODUCT ADMINISTERED (Patient that received first dose of primary series of Moderna Bivalent vaccine), PRODUCT STORAGE ERROR (Vaccines administered beyound 30-day use by date) and NO ADVERSE EVENT (no adverse event). At the time of the report, EXPIRED PRODUCT ADMINISTERED (Vaccines administered after being in stored in fridge past 30 days), WRONG PRODUCT ADMINISTERED (Patient that received first dose of primary series of Moderna Bivalent vaccine) and PRODUCT STORAGE ERROR (Vaccines administered beyound 30-day use by date) 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 (Vaccines administered after being in stored in fridge past 30 days), WRONG PRODUCT ADMINISTERED (Patient that received first dose of primary series of Moderna Bivalent vaccine) and PRODUCT STORAGE ERROR (Vaccines administered beyound 30-day use by date).    No concomitant information was reported. No treatment information was provided.   This case was linked to US-MODERNATX, INC.-MOD-2023-730541 (E2B Linked Report).; Sender's Comments:  US-MODERNATX, INC.-MOD-2023-730541:Master case
Age: 64.0
Sex: U
Vaccine: COVID19-2
Symptoms: Expired product administered, No adverse event, Product storage error, Wrong product administered
Clinical narrative: Vaccines administered after being in stored in fridge past 30 days; Patient that received first dose of primary series of Moderna Bivalent vaccine; Vaccines administered beyound 30-day use by date; No adverse event; This spontaneous case was reported by an other health care professional and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Vaccines administered after being in stored in fridge past 30 days), WRONG PRODUCT ADMINISTERED (Patient that received first dose of primary series of Moderna Bivalent vaccine), PRODUCT STORAGE ERROR (Vaccines administered beyound 30-day use by date) and NO ADVERSE EVENT (No adverse event) in a 64-year-old patient of an unknown gender who received mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (batch no. AS7185B) for COVID-19 prophylaxis.     No Medical History information was reported.    On an unknown date, the patient received first dose of mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced EXPIRED PRODUCT ADMINISTERED (Vaccines administered after being in stored in fridge past 30 days), WRONG PRODUCT ADMINISTERED (Patient that received first dose of primary series of Moderna Bivalent vaccine), PRODUCT STORAGE ERROR (Vaccines administered beyound 30-day use by date) and NO ADVERSE EVENT (No adverse event). At the time of the report, EXPIRED PRODUCT ADMINISTERED (Vaccines administered after being in stored in fridge past 30 days), WRONG PRODUCT ADMINISTERED (Patient that received first dose of primary series of Moderna Bivalent vaccine), PRODUCT STORAGE ERROR (Vaccines administered beyound 30-day use by date) 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 (Vaccines administered after being in stored in fridge past 30 days), WRONG PRODUCT ADMINISTERED (Patient that received first dose of primary series of Moderna Bivalent vaccine) and PRODUCT STORAGE ERROR (Vaccines administered beyound 30-day use by date).    No concomitant information was reported. No treatment information was provided.   This case was linked to US-MODERNATX, INC.-MOD-2023-730554 (E2B Linked Report).; Sender's Comments:  US-MODERNATX, INC.-MOD-2023-730554:same reporter
Age: 81.0
Sex: U
Vaccine: COVID19-2
Symptoms: Expired product administered, No adverse event
Clinical narrative: Vaccines administered after being in stored in fridge past 30 days; No adverse event; This spontaneous case was reported by an other health care professional and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Vaccines administered after being in stored in fridge past 30 days) and NO ADVERSE EVENT (No adverse event) in an 81-year-old patient of an unknown gender who received mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (batch no. AS7185B) for COVID-19 prophylaxis.     No Medical History information was reported.    On an unknown date, the patient received first 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 EXPIRED PRODUCT ADMINISTERED (Vaccines administered after being in stored in fridge past 30 days) and NO ADVERSE EVENT (No adverse event). At the time of the report, EXPIRED PRODUCT ADMINISTERED (Vaccines administered after being in stored in fridge past 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)) (Unknown), the reporter considered NO ADVERSE EVENT (No adverse event) to be not related. No further causality assessment was provided for EXPIRED PRODUCT ADMINISTERED (Vaccines administered after being in stored in fridge past 30 days).    Concomitant medications were not reported.  It was reported that vaccines administered after being in stored in fridge past 30 days.  Treatment information was not reported.
Age: 72.0
Sex: M
Vaccine: COVID19-2
Symptoms: No adverse event, Poor quality product administered, Product temperature excursion issue
Clinical narrative: HCP advised that her office administered vaccines that were reported being out of temperature on 2-24-23; Vaccine was administered to patient after temperature excursion occurred; No adverse event; This spontaneous case was reported by an other health care professional and describes the occurrence of PRODUCT TEMPERATURE EXCURSION ISSUE (HCP advised that her office administered vaccines that were reported being out of temperature on 2-24-23), POOR QUALITY PRODUCT ADMINISTERED (Vaccine was administered to patient after temperature excursion occurred) and NO ADVERSE EVENT (No adverse event) in a 72-year-old male patient who received mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (batch no. 05D22A) for COVID-19 prophylaxis.     The patient's past medical history included Cognitive impairment (mild cognitive impairment).    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 PRODUCT TEMPERATURE EXCURSION ISSUE (HCP advised that her office administered vaccines that were reported being out of temperature on 2-24-23), POOR QUALITY PRODUCT ADMINISTERED (Vaccine was administered to patient after temperature excursion occurred) and NO ADVERSE EVENT (No adverse event). At the time of the report, PRODUCT TEMPERATURE EXCURSION ISSUE (HCP advised that her office administered vaccines that were reported being out of temperature on 2-24-23), POOR QUALITY PRODUCT ADMINISTERED (Vaccine was administered to patient after temperature excursion occurred) 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 PRODUCT TEMPERATURE EXCURSION ISSUE (HCP advised that her office administered vaccines that were reported being out of temperature on 2-24-23) and POOR QUALITY PRODUCT ADMINISTERED (Vaccine was administered to patient after temperature excursion occurred).    No concomitant information was reported. Suspect product dosage text was reported as unknown. It was reported that no confirmation was provided on viability of vaccine vails and as a result office continued to perform vaccination with vials until 30-May-2023. Up to 14 vaccination were administered within that time line. No treatment information was provided.   This case was linked to US-MODERNATX, INC.-MOD-2023-730480 (E2B Linked Report).; Sender's Comments:  US-MODERNATX, INC.-MOD-2023-730480:Same reporter
Age: 72.0
Sex: M
Vaccine: COVID19-2
Symptoms: No adverse event, Poor quality product administered, Product temperature excursion issue
Clinical narrative: HCP advised that her office administered vaccines that were reported being out of temperature on 2-24-23.; Vaccine was administered to a patient after temperature excursion occured; No adverse event; This spontaneous case was reported by an other health care professional and describes the occurrence of PRODUCT TEMPERATURE EXCURSION ISSUE (HCP advised that her office administered vaccines that were reported being out of temperature on 2-24-23.), POOR QUALITY PRODUCT ADMINISTERED (Vaccine was administered to a patient after temperature excursion occured) and NO ADVERSE EVENT (No adverse event) in a 72-year-old male patient who received mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (batch no. 05D22A) for COVID-19 prophylaxis.     Concurrent medical conditions included Hypertension and Hyperlipidemia.    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 PRODUCT TEMPERATURE EXCURSION ISSUE (HCP advised that her office administered vaccines that were reported being out of temperature on 2-24-23.), POOR QUALITY PRODUCT ADMINISTERED (Vaccine was administered to a patient after temperature excursion occured) and NO ADVERSE EVENT (No adverse event). At the time of the report, PRODUCT TEMPERATURE EXCURSION ISSUE (HCP advised that her office administered vaccines that were reported being out of temperature on 2-24-23.), POOR QUALITY PRODUCT ADMINISTERED (Vaccine was administered to a patient after temperature excursion occured) 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 PRODUCT TEMPERATURE EXCURSION ISSUE (HCP advised that her office administered vaccines that were reported being out of temperature on 2-24-23.) and POOR QUALITY PRODUCT ADMINISTERED (Vaccine was administered to a patient after temperature excursion occured).    Patient received any other vaccines in the 4 weeks prior to COVID-19 vaccine were unknown. Concomitant medication details not reported by the reporter. Treatment details was not reported by the reporter.   This case was linked to US-MODERNATX, INC.-MOD-2023-730480 (E2B Linked Report).; Sender's Comments:  US-MODERNATX, INC.-MOD-2023-730480:Same reporter
Sex: U
Vaccine: COVID19-2
Symptoms: Emphysema
Clinical narrative: emphysema; This spontaneous case was reported by a patient and describes the occurrence of EMPHYSEMA (emphysema) in an elderly 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 fifth dose of mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (unknown route) 1 dosage form. On an unknown date, the patient experienced EMPHYSEMA (emphysema). At the time of the report, EMPHYSEMA (emphysema) outcome was unknown.        For mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (Unknown), the reporter did not provide any causality assessments.   No concomitant information was reported. No treatment information was provided.   Reporter did not allow further contact