chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 58.0
Sex: M
Vaccine: VARZOS, VARZOS
Symptoms: Furuncle, Headache, Herpes zoster, Oral herpes, Pain
Clinical narrative: Shingles; Cold sores; Splotches on face/left side of his face that is affected by splotches; Headache, ice pick, temple "electric pulses"; Boils on nose; Pain; This case was reported by a consumer via call center representative and described the occurrence of shingles in a 58-year-old male patient who received Herpes zoster (Shingrix) (batch number 7D73A, expiry date unknown) for prophylaxis.   On 1st April 2022, the patient received the 1st dose of Shingrix (intramuscular). On 1st April 2022, less than a day after receiving Shingrix, the patient experienced blotchy, headache, boil and pain. On 4th April 2022, the patient experienced shingles and cold sores. The patient was treated with valaciclovir (Valacyclovir). On an unknown date, the outcome of the shingles, blotchy, headache, boil, pain and cold sores were not recovered/not resolved.   It was unknown if the reporter considered the shingles, blotchy, headache, boil, pain and cold sores to be related to Shingrix.   Additional Information: GSK Receipt Date: 06-APR-2022 Reporter's Comment: The case was reported by the patient. The patient received Shingrix dose on right arm at approximately at 11:45 am. Around 6 pm on the same day, he noticed splotches on his face and experienced a headache (which he described as an ice pick headache), at his left temple which emanates electric pulses.  The splotches on his face continued to grow over the weekend, as well as the headache at his temple.  He stated that it was his left side of his face that was affected by splotches which also include boils on his nose. He was also experiencing pain. The patient noticed cold sores on his lip, and then went to the doctor and was diagnosed with Shingles.  He was started on Valacyclovir for treatment.  At time of reporting, the patient stated his condition (boils, splotches, cold sores, pain) had stabilized and his headaches were not as frequent. The reporter gave consent to follow up with healthcare professional.
Age: 58.0
Sex: M
Vaccine: VARZOS, VARZOS
Symptoms: Rash macular
Clinical narrative: Shingles; Cold sores; Splotches on face/left side of his face that is affected by splotches; Headache, ice pick, temple "electric pulses"; Boils on nose; Pain; This case was reported by a consumer via call center representative and described the occurrence of shingles in a 58-year-old male patient who received Herpes zoster (Shingrix) (batch number 7D73A, expiry date unknown) for prophylaxis.   On 1st April 2022, the patient received the 1st dose of Shingrix (intramuscular). On 1st April 2022, less than a day after receiving Shingrix, the patient experienced blotchy, headache, boil and pain. On 4th April 2022, the patient experienced shingles and cold sores. The patient was treated with valaciclovir (Valacyclovir). On an unknown date, the outcome of the shingles, blotchy, headache, boil, pain and cold sores were not recovered/not resolved.   It was unknown if the reporter considered the shingles, blotchy, headache, boil, pain and cold sores to be related to Shingrix.   Additional Information: GSK Receipt Date: 06-APR-2022 Reporter's Comment: The case was reported by the patient. The patient received Shingrix dose on right arm at approximately at 11:45 am. Around 6 pm on the same day, he noticed splotches on his face and experienced a headache (which he described as an ice pick headache), at his left temple which emanates electric pulses.  The splotches on his face continued to grow over the weekend, as well as the headache at his temple.  He stated that it was his left side of his face that was affected by splotches which also include boils on his nose. He was also experiencing pain. The patient noticed cold sores on his lip, and then went to the doctor and was diagnosed with Shingles.  He was started on Valacyclovir for treatment.  At time of reporting, the patient stated his condition (boils, splotches, cold sores, pain) had stabilized and his headaches were not as frequent. The reporter gave consent to follow up with healthcare professional.
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Hepatic enzyme, Hepatic enzyme increased, Hepatitis C
Clinical narrative: This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) from medical information team for a Pfizer sponsored program. The reporter is the patient. A female patient received bnt162b2 (BNT162B2), administration date 20Nov2021 (Batch/Lot number: unknown) as dose 3 (booster), single, administration date 09Apr2021 (Batch/Lot number: unknown) as dose 2, single and administration date 17Mar2021 (Batch/Lot number: unknown) as dose 1, single for Covid-19 immunization. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: HEPATITIS C (medically significant), outcome "unknown", described as "Now undergoing Hep C treatment". Therapeutic measures were taken as a result of hepatitis C. Clinical information: No history of elevated liver levels enzymes etc. until after two vaccinations and the booster. Patient asked where he can find copies of liver impact studies related to the Pfizer Vaccine. The lot number for bnt162b2 was not provided and will be requested during follow up.
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Hepatitis C
Clinical narrative: This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) from medical information team for a Pfizer sponsored program. The reporter is the patient. A female patient received bnt162b2 (BNT162B2), administration date 20Nov2021 (Batch/Lot number: unknown) as dose 3 (booster), single, administration date 09Apr2021 (Batch/Lot number: unknown) as dose 2, single and administration date 17Mar2021 (Batch/Lot number: unknown) as dose 1, single for Covid-19 immunization. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: HEPATITIS C (medically significant), outcome "unknown", described as "Now undergoing Hep C treatment". Therapeutic measures were taken as a result of hepatitis C. Clinical information: No history of elevated liver levels enzymes etc. until after two vaccinations and the booster. Patient asked where he can find copies of liver impact studies related to the Pfizer Vaccine. The lot number for bnt162b2 was not provided and will be requested during follow up.
Age: 53.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Chills, Malaise, Pain, SARS-CoV-2 test positive
Clinical narrative: Patient had COVID a couple of months ago; This spontaneous case was reported by a consumer and describes the occurrence of COVID-19 (Patient had COVID a couple of months ago) in a 53-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 051F21A, 043LC0A and 010M20A) for COVID-19 vaccination.     The patient had no chronic illnesses.  Concurrent medical conditions included Allergy to antibiotic (minocycline tetracycline) and Drug allergy (Procainamide).   On 08-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 08-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 15-Nov-2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient experienced COVID-19 (Patient had COVID a couple of months ago). At the time of the report, COVID-19 (Patient had COVID a couple of months ago) outcome was unknown.            No concomitant medications were reported. The patient had had COVID-19 a couple months ago. No treatment medications were reported for first booster shot.  Company comment- This spontaneous case concerns a 53-year-old female patient, with no relevant medical history, who experienced unexpected, non-serious adverse event of special interest Covid-19 (SARS-CoV-2 test positive) approximately 9 months prior to vaccination with third dose of mRNA-1273. Outcome of the event was unknown at the time of this report. The benefit-risk relationship of mRNA-1273 Vaccine is not affected by this report. The case seriousness was assessed as per Regulatory Authority report.   This case was linked to MOD-2022-535490 (Patient Link).   Most recent FOLLOW-UP information incorporated above includes: On 07-Apr-2022: Follow Up received include No New Information.; Sender's Comments: This spontaneous case concerns a 53-year-old female patient, with no relevant medical history, who experienced unexpected, non-serious adverse event of special interest Covid-19 (SARS-CoV-2 test positive) approximately 9 months prior to vaccination with third dose of mRNA-1273. Outcome of the event was unknown at the time of this report. The benefit-risk relationship of mRNA-1273 Vaccine is not affected by this report. The case seriousness was assessed as per Regulatory Authority report.
Age: 53.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: COVID-19
Clinical narrative: Patient had COVID a couple of months ago; This spontaneous case was reported by a consumer and describes the occurrence of COVID-19 (Patient had COVID a couple of months ago) in a 53-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 051F21A, 043LC0A and 010M20A) for COVID-19 vaccination.     The patient had no chronic illnesses.  Concurrent medical conditions included Allergy to antibiotic (minocycline tetracycline) and Drug allergy (Procainamide).   On 08-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 08-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 15-Nov-2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient experienced COVID-19 (Patient had COVID a couple of months ago). At the time of the report, COVID-19 (Patient had COVID a couple of months ago) outcome was unknown.            No concomitant medications were reported. The patient had had COVID-19 a couple months ago. No treatment medications were reported for first booster shot.  Company comment- This spontaneous case concerns a 53-year-old female patient, with no relevant medical history, who experienced unexpected, non-serious adverse event of special interest Covid-19 (SARS-CoV-2 test positive) approximately 9 months prior to vaccination with third dose of mRNA-1273. Outcome of the event was unknown at the time of this report. The benefit-risk relationship of mRNA-1273 Vaccine is not affected by this report. The case seriousness was assessed as per Regulatory Authority report.   This case was linked to MOD-2022-535490 (Patient Link).   Most recent FOLLOW-UP information incorporated above includes: On 07-Apr-2022: Follow Up received include No New Information.; Sender's Comments: This spontaneous case concerns a 53-year-old female patient, with no relevant medical history, who experienced unexpected, non-serious adverse event of special interest Covid-19 (SARS-CoV-2 test positive) approximately 9 months prior to vaccination with third dose of mRNA-1273. Outcome of the event was unknown at the time of this report. The benefit-risk relationship of mRNA-1273 Vaccine is not affected by this report. The case seriousness was assessed as per Regulatory Authority report.
Age: 48.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Angiogram, Computerised tomogram normal, Laboratory test normal, Tinnitus
Clinical narrative: pusitile tinitis; Tinitis; This is a spontaneous report received from contactable reporter(s) (Other HCP). The reporter is the patient.  A 48-year-old male patient received BNT162b2 (BNT162B2), on 22Oct2021 as dose 3 (booster), single (Lot number: EW0191) at the age of 48 years, in right arm for covid-19 immunisation. The patient had no relevant medical history. The patient's concomitant medications were not reported. Vaccination history included: BNT162b2 (Dose Number: 2, Manufacturer: Pfizer, Batch/Lot No: EL3302, Location of injection: Left arm), administration date: 18Jan2021, when the patient was 47-year-old, for COVID-19 immunization; BNT162b2 (Dose Number: 1, Manufacturer: Pfizer, Batch/Lot No: EK9231, Location of injection: Right Arm), administration date: 28Dec2020, when the patient was 47-year-old, for Covid-19 immunization. The following information was reported: TINNITUS (non-serious) with onset 30Nov2021, outcome "not recovered", described as "Tinitis"; TINNITUS (non-serious) with onset 30Nov2021, outcome "not recovered", described as "pusitile tinitis". The events "pusitile tinitis" and "tinitis" required physician office visit. Relevant laboratory tests and procedures are available in the appropriate section. Therapeutic measures were not taken as a result of tinnitus, tinnitus. Additional information: Adverse event: Tinitis, with pusitile tinitis all other workup was negative for another process, CT, CTA, full ENT Workup, fill carotid ultrasound (TCD), Normal BP, normal blood work, no Occlusions. Neurological eval. The Tinitis came on suddenly about 1 month after booster dose. If other vaccine in four weeks: No. Other medications in two weeks: No. If covid prior vaccination: No. If covid tested post vaccination: No. Known allergies: No. Other medical history: None.  No follow-up attempts are possible. No further information is expected.
Age: 48.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Angiogram, Blood pressure measurement, Blood test, Computerised tomogram, Investigation
Clinical narrative: pusitile tinitis; Tinitis; This is a spontaneous report received from contactable reporter(s) (Other HCP). The reporter is the patient.  A 48-year-old male patient received BNT162b2 (BNT162B2), on 22Oct2021 as dose 3 (booster), single (Lot number: EW0191) at the age of 48 years, in right arm for covid-19 immunisation. The patient had no relevant medical history. The patient's concomitant medications were not reported. Vaccination history included: BNT162b2 (Dose Number: 2, Manufacturer: Pfizer, Batch/Lot No: EL3302, Location of injection: Left arm), administration date: 18Jan2021, when the patient was 47-year-old, for COVID-19 immunization; BNT162b2 (Dose Number: 1, Manufacturer: Pfizer, Batch/Lot No: EK9231, Location of injection: Right Arm), administration date: 28Dec2020, when the patient was 47-year-old, for Covid-19 immunization. The following information was reported: TINNITUS (non-serious) with onset 30Nov2021, outcome "not recovered", described as "Tinitis"; TINNITUS (non-serious) with onset 30Nov2021, outcome "not recovered", described as "pusitile tinitis". The events "pusitile tinitis" and "tinitis" required physician office visit. Relevant laboratory tests and procedures are available in the appropriate section. Therapeutic measures were not taken as a result of tinnitus, tinnitus. Additional information: Adverse event: Tinitis, with pusitile tinitis all other workup was negative for another process, CT, CTA, full ENT Workup, fill carotid ultrasound (TCD), Normal BP, normal blood work, no Occlusions. Neurological eval. The Tinitis came on suddenly about 1 month after booster dose. If other vaccine in four weeks: No. Other medications in two weeks: No. If covid prior vaccination: No. If covid tested post vaccination: No. Known allergies: No. Other medical history: None.  No follow-up attempts are possible. No further information is expected.
Age: 48.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Tinnitus, Ultrasound scan
Clinical narrative: pusitile tinitis; Tinitis; This is a spontaneous report received from contactable reporter(s) (Other HCP). The reporter is the patient.  A 48-year-old male patient received BNT162b2 (BNT162B2), on 22Oct2021 as dose 3 (booster), single (Lot number: EW0191) at the age of 48 years, in right arm for covid-19 immunisation. The patient had no relevant medical history. The patient's concomitant medications were not reported. Vaccination history included: BNT162b2 (Dose Number: 2, Manufacturer: Pfizer, Batch/Lot No: EL3302, Location of injection: Left arm), administration date: 18Jan2021, when the patient was 47-year-old, for COVID-19 immunization; BNT162b2 (Dose Number: 1, Manufacturer: Pfizer, Batch/Lot No: EK9231, Location of injection: Right Arm), administration date: 28Dec2020, when the patient was 47-year-old, for Covid-19 immunization. The following information was reported: TINNITUS (non-serious) with onset 30Nov2021, outcome "not recovered", described as "Tinitis"; TINNITUS (non-serious) with onset 30Nov2021, outcome "not recovered", described as "pusitile tinitis". The events "pusitile tinitis" and "tinitis" required physician office visit. Relevant laboratory tests and procedures are available in the appropriate section. Therapeutic measures were not taken as a result of tinnitus, tinnitus. Additional information: Adverse event: Tinitis, with pusitile tinitis all other workup was negative for another process, CT, CTA, full ENT Workup, fill carotid ultrasound (TCD), Normal BP, normal blood work, no Occlusions. Neurological eval. The Tinitis came on suddenly about 1 month after booster dose. If other vaccine in four weeks: No. Other medications in two weeks: No. If covid prior vaccination: No. If covid tested post vaccination: No. Known allergies: No. Other medical history: None.  No follow-up attempts are possible. No further information is expected.
Age: 35.0
Sex: F
Vaccine: COVID19
Symptoms: Blood thyroid stimulating hormone increased, C-reactive protein, Dyspnoea, Fatigue, Gastrooesophageal reflux disease
Clinical narrative: Shortness of breath beginning immediately after vaccine, ongoing now for 3 weeks; fever, ongoing now for 3 weeks; tachycardia, ongoing now for 3 weeks; heart palpitations; headache for 3 weeks; tremor; paraesthesia; nerve pain; extreme fatigue; acid reflux.
Age: 35.0
Sex: F
Vaccine: COVID19
Symptoms: Headache, Immediate post-injection reaction, Neuralgia, Palpitations, Paraesthesia
Clinical narrative: Shortness of breath beginning immediately after vaccine, ongoing now for 3 weeks; fever, ongoing now for 3 weeks; tachycardia, ongoing now for 3 weeks; heart palpitations; headache for 3 weeks; tremor; paraesthesia; nerve pain; extreme fatigue; acid reflux.
Age: 35.0
Sex: F
Vaccine: COVID19
Symptoms: Pyrexia, Red blood cell sedimentation rate normal, Tachycardia, Tremor, Troponin increased
Clinical narrative: Shortness of breath beginning immediately after vaccine, ongoing now for 3 weeks; fever, ongoing now for 3 weeks; tachycardia, ongoing now for 3 weeks; heart palpitations; headache for 3 weeks; tremor; paraesthesia; nerve pain; extreme fatigue; acid reflux.
Age: 47.0
Sex: F
Vaccine: COVID19
Symptoms: Tinnitus
Clinical narrative: Within a few weeks of my second vaccine I started having tinnitus. I did not realize it was vaccine related until recent reports. I couldn?t figure out why I had tinnitus, but now I know.
Sex: U
Vaccine: VARCEL
Symptoms: No adverse event, Product storage error
Clinical narrative: No other issues or concerns noted; Improperly stored administered VARIVAX/Temperature excursion information: (-11.83C) for 2 hours and 30 minutes; This spontaneous report was received from other reporter, referring to a patient of unknown age and gender. No information regarding the patient's concurrent conditions, medical history and concomitant medications was provided.  On 24-MAR-2022, the patient was vaccinated with a dose of improperly stored (product storage error) varicella virus vaccine live (oka/merck) (VARIVAX) lot #: U016065, expiration date: 20-MAY-2023 (exact dose, strength, site and route of administration were not provided) for prophylaxis. Temperature excursion information: -11.83 degree Celsius for 2 hours and 30 minutes. No other issues or concerns noted (no adverse event).   This is one of several reports received from the same reporter.; Sender's Comments:  US-009507513-2204USA004064: US-009507513-2204USA004065: US-009507513-2204USA004066: US-009507513-2204USA004067: US-009507513-2204USA004068: US-009507513-2204USA004069: US-009507513-2204USA004070: US-009507513-2204USA004071:
Sex: U
Vaccine: VARCEL
Symptoms: No adverse event, Product storage error
Clinical narrative: No other issues or concerns noted; Improperly stored administered VARIVAX/Temperature excursion information: (-11.83C) for 2 hours and 30 minutes; This spontaneous report was received from other reporter, referring to a patient of unknown age and gender. No information regarding the patient's concurrent conditions, medical history and concomitant medications was provided.  On 24-MAR-2022, the patient was vaccinated with a dose of improperly stored (product storage error) varicella virus vaccine live (oka/merck) (VARIVAX) lot #: U016065, expiration date: 20-MAY-2023 (exact dose, strength, site and route of administration were not provided) for prophylaxis. Temperature excursion information: -11.83 degree Celsius for 2 hours and 30 minutes. No other issues or concerns noted (no adverse event).   This is one of several reports received from the same reporter.; Sender's Comments:  US-009507513-2204USA004055:
Age: 1.92
Sex: U
Vaccine: MMR, VARCEL
Symptoms: Expired product administered
Clinical narrative: No additional AE reported; an expired vial of STERILE DILUENT was accidently used to reconstitute a dose of MMR II and VARIVAX and then was administered to a patient. The vial of STERILE DILUENT expired on Mar 24 2022, and was used and administered on Apr 5, 2022; an expired vial of STERILE DILUENT was accidently used to reconstitute a dose of MMR II and VARIVAX; This spontaneous report was received from a registered nurse referring to a 23 months old patient. Information about medical history, concurrent conditions and concomitant therapies was not provided.   The reporter stated that an expired vial of sterile diluent (STERILE DILUENT) (lot # S026376, expiration date reported as 24-MAR-2022, but upon internal validation established as 24-MAR-2020, once; strength, dose, route were not reported) was accidently used to reconstitute a dose of measles, mumps, and rubella (wistar ra 27-3) virus vaccine, live (rHA) (M-M-R II) (lot number: T029549, expiration date reported as 01-SEP-2022, but upon internal validation established as 10-SEP-2022, once; route not reported) and varicella virus vaccine live (oka/merck) (VARIVAX) (lot number: U024221, expiration date: 04-AUG-2023, once; dose and route were not reported) as prophylaxis, and then was administered to the patient on 05-APR-2022 (expired product administered, product preparation error). The sterile diluent (STERILE DILUENT) had no prior temperature excursions. No additional adverse event (AE) was reported.
Sex: U
Vaccine: VARCEL
Symptoms: No adverse event, Product storage error
Clinical narrative: No additional AE reported; A vaccine coordinator reported VARIVAX was administered after a temperature excursion.; This spontaneous report was received from a vaccine coordinator referring to a patient of unknown age and gender. Concomitant medication, pertinent medical history and drug reactions/allergies were not reported.  On 07-APR-2022, the patient was vaccinated with improperly stored varicella virus vaccine live (oka/merck)(VARIVAX) (strength, dose and route were not reported; lot # u025791 was evaluated and changed to the valid lot # U025791, expiration date: 19-AUG-2023) for prophylaxis (product storage error).         It was reported that the suspect vaccine was exposed to a temperature of minus 11.83 degree Celsius for a time frame of 15 minutes; Previous temperature excursion included 9.37 degree Celsius for a time frame of 2 hours and 30 min.    No additional adverse event (AE) information was provided (no adverse event).  This is one of the multiple cases reported by the same reporter.; Sender's Comments:  US-009507513-2204USA002815:
Sex: U
Vaccine: MMRV
Symptoms: No adverse event, Product storage error
Clinical narrative: No additional AE reported; A vaccine coordinator reported PROQUAD was administered after a temperature excursion.; This spontaneous report was received from a vaccine coordinator referring to a patient of unknown age and gender. Concomitant medication, pertinent medical history and drug reactions/allergies were not reported.  On 23-MAR-2022, the patient was vaccinated with improperly stored measles, mumps, rubella and varicella (oka-merck) virus vaccine live (recombinant human albumin (rHA)) (PROQUAD) (strength, dose and route were not reported; lot # U022729, expiration date: 16-JAN-2023) for prophylaxis (product storage error).       It was reported that the suspect vaccine was exposed to a temperature of minus 11.83 degree Celsius for a time frame of 15 minutes. Previous temperature excursion included 9.37 degree Celsius for a time frame of 2 hours and 30 min.    No additional adverse event (AE) information was provided (no adverse event).  This is one of the multiple cases reported by the same reporter.; Sender's Comments:  US-009507513-2204USA002815:
Sex: U
Vaccine: MMRV
Symptoms: No adverse event, Product storage error
Clinical narrative: No additional AE reported; A vaccine coordinator reported PROQUAD was administered after a temperature excursion.; This spontaneous report was received from a vaccine coordinator referring to a patient of unknown age and gender. Concomitant medication, pertinent medical history and drug reactions/allergies were not reported.  On 23-MAR-2022, the patient was vaccinated with improperly stored measles, mumps, rubella and varicella (oka-merck) virus vaccine live (recombinant human albumin (rHA)) (PROQUAD) (strength, dose and route were not reported; lot # U022729, expiration date: 16-JAN-2023) for prophylaxis (product storage error).       It was reported that the suspect vaccine was exposed to a temperature of minus 11.83 degree Celsius for a time frame of 15 minutes; Previous temperature excursion included 9.37 degree Celsius for a time frame of 2 hours and 30 min.    No additional adverse event (AE) information was provided (no adverse event).  This is one of the multiple cases reported by the same reporter.; Sender's Comments:  US-009507513-2204USA002815:
Sex: U
Vaccine: MMRV
Symptoms: No adverse event, Product storage error
Clinical narrative: No additional AE reported; A vaccine coordinator reported PROQUAD was administered after a temperature excursion.; This spontaneous report was received from a vaccine coordinator referring to a patient of unknown age and gender. Concomitant medication, pertinent medical history and drug reactions/allergies were not reported.  On 23-MAR-2022, the patient was vaccinated with improperly stored measles, mumps, rubella and varicella (oka-merck) virus vaccine live (recombinant human albumin (rHA)) (PROQUAD) (strength, dose and route were not reported; lot # U022729, expiration date: 16-JAN-2023) for prophylaxis (product storage error).       It was reported that the suspect vaccine was exposed to a temperature of minus 11.83 degree Celsius for a time frame of 15 minutes; Previous temperature excursion included 9.37 degree Celsius for a time frame of 2 hours and 30 min.     No additional adverse event (AE) information was provided (no adverse event).  This is one of the multiple cases reported by the same reporter.; Sender's Comments:  US-009507513-2204USA002815:
Sex: U
Vaccine: MMRV
Symptoms: No adverse event, Product storage error
Clinical narrative: No additional AE reported; A vaccine coordinator reported PROQUAD was administered after a temperature excursion.; This spontaneous report was received from a vaccine coordinator referring to a patient of unknown age and gender. Concomitant medication, pertinent medical history and drug reactions/allergies were not reported.  On 24-MAR-2022, the patient was vaccinated with improperly stored measles, mumps, rubella and varicella (oka-merck) virus vaccine live (recombinant human albumin (rHA)) (PROQUAD) (strength, dose and route were not reported; lot # U022729, expiration date: 16-JAN-2023) for prophylaxis (product storage error).       It was reported that the suspect vaccine was exposed to a temperature of minus 11.83 degree Celsius for a time frame of 15 minutes; Previous temperature excursion included 9.37 degree Celsius for a time frame of 2 hours and 30 min.     No additional adverse event (AE) information was provided (no adverse event).  This is one of the multiple cases reported by the same reporter.; Sender's Comments:  US-009507513-2204USA002815:
Sex: U
Vaccine: MMRV
Symptoms: No adverse event, Product storage error
Clinical narrative: No additional AE reported; A vaccine coordinator reported PROQUAD was administered after a temperature excursion.; This spontaneous report was received from a vaccine coordinator referring to a patient of unknown age and gender. Concomitant medication, pertinent medical history and drug reactions/allergies were not reported.  On 25-MAR-2022, the patient was vaccinated with improperly stored measles, mumps, rubella and varicella (oka-merck) virus vaccine live (recombinant human albumin (rHA)) (PROQUAD) (strength, dose and route were not reported; lot # U029319, expiration date: 19-MAR-2023) for prophylaxis (product storage error).       It was reported that the suspect vaccine was exposed to a temperature of minus 11.83 degree Celsius for a time frame of 15 minutes; Previous temperature excursion included 9.37 degree Celsius for a time frame of 2 hours and 30 min.     No additional adverse event (AE) information was provided (no adverse event).  This is one of the multiple cases reported by the same reporter.; Sender's Comments:  US-009507513-2204USA002815:
Sex: U
Vaccine: MMRV
Symptoms: No adverse event, Product storage error
Clinical narrative: No additional AE reported; A vaccine coordinator reported PROQUAD was administered after a temperature excursion.; This spontaneous report was received from a vaccine coordinator referring to a patient of unknown age and gender. Concomitant medication, pertinent medical history and drug reactions/allergies were not reported.  On 29-MAR-2020 (as reported), the patient was vaccinated with improperly stored measles, mumps, rubella and varicella (oka-merck) virus vaccine live (recombinant human albumin (rHA)) (PROQUAD) (strength, dose and route were not reported; lot # U022729, expiration date: 16-JAN-2023) for prophylaxis (product storage error).       It was reported that the suspect vaccine was exposed to a temperature of minus 11.83 degree Celsius for a time frame of 15 minutes; Previous temperature excursion included 9.37 degree Celsius for a time frame of 2 hours and 30 min.    No additional adverse event (AE) information was provided (no adverse event).  This is one of the multiple cases reported by the same reporter.; Sender's Comments:  US-009507513-2204USA002815:
Sex: U
Vaccine: MMRV
Symptoms: Product storage error
Clinical narrative: No additional AE reported; A vaccine coordinator reported PROQUAD was administered after a temperature excursion.; This spontaneous report was received from a vaccine coordinator referring to a patient of unknown age and gender. Concomitant medication, pertinent medical history and drug reactions/allergies were not reported.  On 03-MAR-2022, the patient was vaccinated with improperly stored measles, mumps, rubella and varicella (oka-merck) virus vaccine live (recombinant human albumin (rHA)) (PROQUAD) (strength, dose and route were not reported; lot # U022729, expiration date: 16-JAN-2023) for prophylaxis (product storage error).       It was reported that the suspect vaccine was exposed to a temperature of minus 11.83 degree Celsius for a time frame of 15 minutes. Previous temperature excursion included 9.37 degree Celsius for a time frame of 2 hours and 30 min.      No additional adverse event (AE) information was provided (no adverse event).  This is one of the multiple cases reported by the same reporter.; Sender's Comments:  US-009507513-2204USA002815:
Sex: U
Vaccine: MMRV
Symptoms: No adverse event, Product storage error
Clinical narrative: No additional AE reported; A vaccine coordinator reported PROQUAD was administered after a temperature excursion.; This spontaneous report was received from a vaccine coordinator referring to a patient of unknown age and gender. Concomitant medication, pertinent medical history and drug reactions/allergies were not reported.  On 31-MAR-2022, the patient was vaccinated with improperly stored measles, mumps, rubella and varicella (oka-merck) virus vaccine live (recombinant human albumin (rHA)) (PROQUAD) (strength, dose and route were not reported; lot # U022729, expiration date: 16-JAN-2023) for prophylaxis (product storage error).       It was reported that the suspect vaccine was exposed to a temperature of minus 11.83 degree Celsius for a time frame of 15 minutes. Previous temperature excursion included 9.37 degree Celsius for a time frame of 2 hours and 30 min.      No additional adverse event (AE) information was provided (no adverse event).  This is one of the multiple cases reported by the same reporter.; Sender's Comments:  US-009507513-2204USA002815:
Sex: U
Vaccine: PPV
Symptoms: No adverse event, Product storage error
Clinical narrative: No further adverse events; Doses administered during temperature excursion; This spontaneous report was received from a office manager (who was a clinical manager and also a medical assistant) and refers to a patient of unknown age and gender. Information about medical history, concurrent conditions and concomitant therapies was not provided.  On 18-MAR-2022, improperly stored pneumococcal vaccine, polyvalent (23-valent)(PNEUMOVAX23) syringe (lot#U018309 and expiration date:08-JAN-2023) (dose, route of administration and anatomical location were not provided) was administered to the patient for prophylaxis (product storage error). No additional adverse event was reported.  This is one of three reports received from the same reporter. ; Sender's Comments:  US-009507513-2203USA007589: US-009507513-2204USA005263:
Sex: U
Vaccine: MMRV, VARCEL
Symptoms: Overdose, Vaccination error
Clinical narrative: a dose of PROQUAD was administered with VARIVAX for 8 different patients; This spontaneous report was received from a pharmacy technician referring to a patient of unknown age and gender. The patient's concurrent conditions, medical history, drug reactions/allergies and concomitant therapies were not reported.  On 06-APR-2022, the patient was vaccinated with varicella virus vaccine live (oka/merck) (VARIVAX) 1 dose, lot #U024221, expiration date 04-AUG-2023 (strength and route were not provided), with measles, mumps, rubella and varicella (oka-merck) virus vaccine live recombinant Human albumin (rHA) (PROQUAD) 1 dose, lot #U028179, expiration date 08-MAR-2023 (strength and route were not provided) for prophylaxis (overdose). The pharmacy technician reported the information was shared with her by a nurse at one of their facility's clinic. It was unknown if any product confusion occurred, that may have contributed to the error.   This is one of eight reports received from the same reporter.
Sex: U
Vaccine: PPV
Symptoms: No adverse event, Product storage error
Clinical narrative: No further adverse events; Doses administered during temperature excursion; This spontaneous report was received from a office manager  (who was a clinical manager and also a medical assistant) and refers to a patient of unknown age and gender. Information about medical history, concurrent conditions and concomitant therapies was not provided.  On 22-DEC-2021, improperly stored pneumococcal vaccine, polyvalent (23-valent)(PNEUMOVAX23) syringe (lot#U018309 and expiration date:08-JAN-2023) (dose, route of administration and anatomical location were not provided) was administered to the patient for prophylaxis (product storage error). No additional adverse event was reported.  This is one of three reports received from the same reporter. ; Sender's Comments:  US-009507513-2203USA007589: US-009507513-2204USA004696:
Sex: U
Vaccine: VARZOS
Symptoms: Herpes zoster
Clinical narrative: Shingles; This case was reported by a consumer via interactive digital media and described the occurrence of shingles in a patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   On an unknown date, the patient received the 1st dose of Shingles vaccine. On an unknown date, unknown after receiving Shingles vaccine, the patient experienced shingles. On an unknown date, the outcome of the shingles was unknown.   It was unknown if the reporter considered the shingles to be related to Shingles vaccine.     Additional Information: GSK Receipt Date: 08-APR-2022 Reporter's comment: This case was reported by patient via  interactive digital media. The patient reported that he/she received first shot of Shingles vaccine and experienced shingles second time. The patient was supposed to get other shot in July but patient still thinking about not getting it.  Additional Supportive Information:  The follow-up would not possible as no contact details were available.
Sex: U
Vaccine: VARZOS
Symptoms: Incomplete course of vaccination
Clinical narrative: 1st shot last July. Is too late to get 2nd dose?; This case was reported by a consumer via interactive digital media and described the occurrence of incomplete course of vaccination in a patient who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included Shingrix (1st dose received in July 2021).   On an unknown date, the patient did not receive the 2nd dose of Shingrix. On an unknown date, unknown after receiving Shingrix, the patient experienced incomplete course of vaccination. On an unknown date, the outcome of the incomplete course of vaccination was unknown.   Additional Information: GSK Receipt Date: 12-Apr-2022 Reporter's comments: This case was received from Shingrix. This case was reported by the patient. The patient received first shot of Shingrix last July before the date of reporting. The reporter asked if it was too late to get 2nd dose or need to start all over. Additional Supportive Information: Till the time of reporting the patient did not receive 2nd dose of Shingrix, which led to incomplete course of vaccination.
Sex: U
Vaccine: VARZOS
Symptoms: Herpes zoster, Vaccination failure
Clinical narrative: had the shot, still had shingles/suspected vaccination failure; shingles; This 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, unknown after receiving Shingles vaccine, the patient experienced vaccination failure (serious criteria GSK medically significant) and shingles. On an unknown date, the outcome of the vaccination failure and shingles were unknown.   It was unknown if the reporter considered the vaccination failure and shingles to be related to Shingles vaccine.   Additional Information: GSK Receipt Date: 11-APR-2022 Reporter's Comment: This case was reported by the patient via interactive digital media. The patient had the Shingles shot but still had the shingles but not bad. Additional Supportive Information: This case described the occurrence of suspected vaccination failure. This case was considered as suspected vaccination failure as details regarding completion of primary vaccination schedule, time to onset and laboratory test confirming shingles were unknown at the time of reporting. The follow up would not possible as no contact details were available.
Age: 0.5
Sex: U
Vaccine: DTAPHEPBIP
Symptoms: Inappropriate schedule of product administration
Clinical narrative: 3er dose at 6 month of age on April 4th 2022,  second dose was administered on February 23rd 2022; This case was reported by a other health professional via call center representative and described the occurrence of drug dose administration interval too short in a 6-month-old patient who received DTPa-HBV-IPV (Pediarix) for prophylaxis.   Co-suspect products included dtpa-hbv-ipv vaccine pre-filled syringe device (Pediarix Pre-Filled Syringe Device) injection syringe for prophylaxis.   Previously administered products included Pediarix (1st dose of Pediarix received on 22nd December 2021). Concomitant products included PEDIARIX.   On 4th April 2022, the patient received the 3rd dose of Pediarix and Pediarix Pre-Filled Syringe Device. On 4th April 2022, unknown after receiving Pediarix and Pediarix Pre-Filled Syringe Device, the patient experienced drug dose administration interval too short. On an unknown date, the outcome of the drug dose administration interval too short 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: 05-APR-2022 Reporter's Comment: The reporter was medical assistant. The patient's identifiers and vaccine lot number was not gathered.  The Vaccine Administration Facility was the same as Primary Reporter. The reporter did not consent to follow-up. Additional Supportive Information: The reporter reported that the patient received the third dose of Pediarix earlier than the recommended interval, which led to shortening of vaccination schedule.
Age: 66.0
Sex: F
Vaccine: VARZOS
Symptoms: Chills, Diarrhoea, Retching, Vomiting
Clinical narrative: Diarrhea; Vomiting; Chills; Dry heaving; This case was reported by a consumer via call center representative and described the occurrence of chills in a 66-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   On 1st April 2022, the patient received the 1st dose of Shingrix. On 4th April 2022, 3 days after receiving Shingrix, the patient experienced chills and dry heaves. On 5th April 2022, the patient experienced vomiting. On 6th April 2022, the patient experienced diarrhea. On 5th April 2022, the outcome of the chills, dry heaves and vomiting were recovered/resolved. On an unknown date, the outcome of the diarrhea was not recovered/not resolved.   It was unknown if the reporter considered the chills, dry heaves, vomiting and diarrhea to be related to Shingrix.     Additional Information: GSK Receipt Date: 6-APR-2022 Reporter's Comment: The patient self-reported that, after vaccination she experienced chills and dry heaving. The patient stated that continuing to experienced dry heaving that later progressed to vomiting after eating. On 6th April 2022, 6 days later, the patient experienced diarrhea. The reporter did not consent to follow-up.
Sex: F
Vaccine: VARZOS
Symptoms: Incorrect route of product administration
Clinical narrative: Shingrix administrated subcutaneous; This case was reported by a pharmacist via call center representative and described the occurrence of intramuscular formulation administered by other route in a adult female patient who received Herpes zoster (Shingrix) (batch number 2g2x7, expiry date 29th July 2023) for prophylaxis.   On an unknown date, the patient received Shingrix (subcutaneous). On an unknown date, unknown after receiving Shingrix, the patient experienced intramuscular formulation administered by other route. On an unknown date, the outcome of the intramuscular formulation administered by other route was unknown.   Additional Information: GSK Receipt Date: 06-APR-2022 Reporter's Comment: No adverse event was reported . The Vaccine Administration Facility was the same as primary reporter. The reporter consented to follow up.  Additional Supportive Information: The reporter reported that a patient was administrated in another site(subcutaneous) Shingrix, which led to intramuscular formulation administered by other route.
Age: 55.0
Sex: F
Vaccine: VARZOS
Symptoms: Extra dose administered
Clinical narrative: received a third dose; This case was reported by a other health professional via call center representative and described the occurrence of extra dose administered in a 55-year-old female patient who received Herpes zoster (Shingrix) (batch number Z42G4, expiry date 26th August 2023) for prophylaxis.   Previously administered products included Shingrix (the patient received 2nd dose of Shingrix in 2018).   On 6th April 2022, the patient received the 3rd dose of Shingrix. On 6th April 2022, unknown after receiving Shingrix, the patient experienced extra dose administered. On an unknown date, the outcome of the extra dose administered was unknown.   Additional Information: GSK Receipt Date: 06-APR-2022 Additional Supportive Information: The patient received a third dose of Shingrix, which led to extra dose administered. The reporter consented to follow up.
Sex: U
Vaccine: MENB
Symptoms: Expired product administered
Clinical narrative: received an expired dose; This case was reported by a nurse via call center representative and described the occurrence of expired vaccine used in a patient who received Men B NVS (Bexsero) (batch number unknown, expiry date 31st January 2022) for prophylaxis.   Co-suspect products included meningococcal B recom vaccine + aloh + omv pre-filled syringe device (Bexsero Pre-Filled Syringe Device) injection syringe for prophylaxis.   On 6th April 2022, the patient received Bexsero and Bexsero Pre-Filled Syringe Device. On 6th April 2022, unknown after receiving Bexsero and Bexsero Pre-Filled Syringe Device, the patient experienced expired vaccine used. On an unknown date, the outcome of the expired vaccine used was unknown.   This report is made by GSK without prejudice and does not imply any admission or liability for the incident or its consequences.   Additional Information: GSK Receipt Date: 06-APR-2022 Reporter's Comment: No patient's details were provided when asked. The lot number was unavailable when asked. The reporter did not consent to follow-up. Additional Supportive Information: The patient received an expired dose of Bexsero, which led to expired vaccine used.
Age: 17.0
Sex: M
Vaccine: MNQ
Symptoms: Incorrect dose administered, Product preparation error
Clinical narrative: received Menveo reconstituted with sterile water; received Menveo reconstituted with sterile water; This 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 17-year-old male patient who received Men ACWY-CRM NVS (Menveo) (batch number AMVA585A, expiry date 31st March 2022) for prophylaxis.   On 31st March 2022, the patient received Menveo. On 31st March 2022, unknown after receiving Menveo, the patient experienced wrong solution used in drug reconstitution and inappropriate dose of vaccine administered. On an unknown date, the outcome of the wrong solution used in drug reconstitution and inappropriate dose of vaccine administered were unknown.   Additional Information: GSK Receipt Date: 06-APR-2022 Reporter's Comment: No reactions were reported. The reporter consented to follow up via email. Additional Supportive Information: The patient received Menveo after being reconstituted with sterile water, which led to wrong solution used in drug reconstitution and inappropriate dose of vaccine administered.
Age: 44.0
Sex: F
Vaccine: HEPA
Symptoms: Inappropriate schedule of product administration
Clinical narrative: 2 dose of Havrix after one month of the first dose; This case was reported by a pharmacist via call center representative and described the occurrence of drug dose administration interval too short in a 44-year-old female patient who received HAV (Havrix 1440) (batch number unknown, expiry date 20th May 2022) for prophylaxis.   Concomitant products included HEPATITIS A VACCINE (HAVRIX 1440).   On 11th November 2021, the patient received the 2nd dose of Havrix 1440. On 11th November 2021, unknown after receiving Havrix 1440 and an unknown time after receiving HAVRIX 1440, the patient experienced drug dose administration interval too short. On an unknown date, the outcome of the drug dose administration interval too short was unknown.   Additional Information: GSK Receipt Date: 06-APR-2022 Reporter's Comment: The reporter consented to follow up. Additional Supportive Information: The reporter reported that ,a patient been inadvertently given the 2 dose of Havrix after one month of the first dose, which led to shortening of vaccination schedule.