chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Sex: U
Vaccine: PPV, UNK
Symptoms: No adverse event, Product storage error
Clinical narrative: No additional AE information provided; the patient was administered an improperly stored dose of PNEUMOVAX23; This spontaneous report as received from a Licensed Practical Nurse refers to a patient of unknown age and gender. Patient's concurrent conditions, medical history and concomitant therapies were not reported.    On 29-AUG-2019, the patient was vaccinated with an improperly stored dose of pneumococcal vaccine, polyvalent (23-valent)(PNEUMOVAX23) (route and dosage schedule were not reported) lot # S004548, exp date: 12-AUG-2020 for prophylaxis. No adverse event reported.    The temperature excursion was of 47.3 degrees Fahrenheit, for 20 minutes. No previous temperature excursion reported. A data logger was used.  This is one of several reports received from the same reporter. combinationproductreport: Yes; brandname: PNEUMOVAX23 SYRINGE (DEVICE); commondevicename: Pneumococcal Vaccine, Polyvalent (23-valent); productcode: FMF; manufacturername: Merck Sharp & Dohme Corp.; manufactureraddress: ; manufacturercity: ; manufacturerstate: ; manufacturercountry: ; devicelotnumber: S004548; expirationdate: 12-AUG-2020; deviceage and unit: 0 ; malfunction: Unknown; deviceusage: Unknown; evaluatedbymfr: Not returned to manufacturer; reasonfornoneval: 81 Other; labeledsingleusedevice: No; mdcpreportability: No; mdcpreprationale: Case information does not meet the criteria for Reportability; Sender's Comments:  US-009507513-2005USA000302:
Sex: F
Vaccine: VARZOS
Symptoms: Herpes zoster
Clinical narrative: Shingles; This initial spontaneous report was received from a lawyer regarding a case in litigation referring to a female patient of unknown age. The patient's pertinent medical history, concurrent conditions or concomitant medications were not reported. On an unspecified date in 2014, the patient was vaccinated with zoster vaccine live (ZOSTAVAX) (lot#, expiration date, dosage and route of administration were not provided) for the long-term prevention of shingles and zoster-related conditions. On an unspecified date, subsequent to inoculation, the pt was treated for shingles. The pt had and would continue suffering ongoing injuries, including but not limited to: mental and physical pain and suffering; medical care and treatment for these injuries; significant medical and related expenses as a result of these injuries, including but not limited to medical losses and costs include care for hospitalization, physician care, monitoring, treatment, medications, and supplies; diminished capacity for the enjoyment of life; diminished quality of life; increased risk of premature death, aggravation of preexisting conditions and activation of latent conditions; and other losses and damages; and will continue to suffer such losses, and damages in the future. At the time of the report, the outcome of shingles was unknown. The reporter considered shingles to be related to Zoster Vaccine Live (ZOSTAVAX).
Sex: U
Vaccine: MMRV
Symptoms: No adverse event, Product storage error
Clinical narrative: No adverse symptoms reported; the patient received an improperly stored dose of PROQUAD on 5/4/2020; This spontaneous report was received from a registered nurse, referring to a patient of unknown age and gender. No information regarding the patient's pertinent medical history and drug reactions or allergies was provided.   On 04-MAY-2020, the patient received an improperly stored dose of measles, mumps, rubella and varicella (oka-merck) virus vaccine live (therapy type: recombinant Human albumin (rHA)) (PROQUAD) (lot#S031883 with expiration date: 07-APR-2021; dose, frequency, strength and route of administration were not provided) with sterile diluent for prophylaxis. No adverse symptoms reported.  Administered dose of measles, mumps, rubella and varicella (oka-merck) virus vaccine live (PROQUAD) experienced the temperature excursion under -14 degrees Celsius (C) to -10 degrees Celsius (-12.9C) for 1 hour 8 minutes. There was no previous temperature excursion. The digital data logger was involved to capture the temperature excursion.
Sex: U
Vaccine: HPV9, UNK
Symptoms: Product administered to patient of inappropriate age, Wrong product administered
Clinical narrative: Medical assistant reported the patient was supposed to be administered a dose of Prevnar 13 but the medical assistant accidentally administered a dose ofGARDASIL 9 instead.; 4 month old patient was administered a dose of GARDASIL 9 in error on 06-MAY-2020; This spontaneous report was received from a medical assistant referring to a 4-month-old patient. The patient's pertinent concurrent conditions, medical history, concomitant medications and previous drug reactions or allergies were not provided.  On 06-MAY-2020, the patient was vaccinated with a dose of hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast) (GARDASIL 9) as prophylaxis (concentration, number of administered dose, vaccination scheme frequency, route and anatomical location of vaccination were not reported; lot number 1621931 and expiration date 26-JAN-2022). Medical assistant reported that the patient was supposed to be administered a dose of pneumococcal 13v conj vaccine (crm197) (PREVNAR 13), but the medical assistant accidentally administered a dose of hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast) (GARDASIL 9) instead (wrong product administered and product administered to patient of inappropriate age). combinationproductreport: Yes; brandname: GARDASIL 9 SYRINGE (DEVICE); commondevicename: HPV rL1 6 11 16 18 31 33 45 52 58 VLP vaccine (yeast); productcode: FMF; devicetype: SYRINGE, PISTON (FMF); manufacturername: Merck Sharp & Dohme Corp.; devicelotnumber: 1621931; expirationdate: 26-JAN-2022; deviceage and unit: 0 ; operatorofdevice: Medical Assistant; malfunction: Unknown; deviceusage: Unknown; evaluatedbymfr: Not returned to manufacturer; reasonfornoneval: 81 Other; labeledsingleusedevice: No; mdcpreportability: No; mdcpreprationale: Case information does not meet the criteria for Reportability
Sex: U
Vaccine: MMRV
Symptoms: No adverse event, Product storage error
Clinical narrative: No adverse events; Administered a dose of improperly stored proquad; This spontaneous report was received from a nurse referring to a patient of an unknown age and gender. The patient's concurrent conditions, medical history, drug reaction/allergy and concomitant medication were not reported. On 28-APR-2020 the patient was vaccinated with improperly stored measles, mumps, rubella and varicella (oka-merck) virus vaccine live (PROQUAD) (product storage error) subcutaneously (dose, frequency were not reported) lot # S023651, expiry date: 26-JAN-2021, for prophylaxis. The vaccine was reconstituted with properly stored sterile diluent. The vaccine was stored at a temperature of minus 8.1 degree Celsius for 1 hour 30 minutes. There was no previous temperature excursion. The call was because of data logger. No adverse effect was reported. The outcome of product storage error and no adverse event was unknown.
Sex: U
Vaccine: VARCEL
Symptoms: Product storage error
Clinical narrative: improperly stored one dose of VARIVAX was administered; This spontaneous report was received from a medical assistant referring to a 12 month old patient of unknown gender. The patient's pertinent medical history, concurrent conditions, previous drug allergies or reactions and concomitant medications were not reported.  On 29-APR-2020, the patient was vaccinated with one improperly stored dose of varicella virus vaccine live (oka/merck)(VARIVAX) lot # S028918 with expiration date on 16-SEP-2021, by subcutaneous route for varicella immunisation (strength, dose, anatomical location, and route of administration were not reported), which was reconstitued with properly stored sterile diluent (MERCK STERILE DILUENT).    The administered dose of tvaricella virus vaccine live (oka/merck)(VARIVAX) experienced a temperature excursion of 12.2°F (degrees Fahrenheit) for 26 minutes, as recorded by a data logger. No previous temperature excursion was reported. Furthermore, no product quality complaint was involved.
Age: 66.0
Sex: U
Vaccine: PPV, UNK
Symptoms: No adverse event, Product storage error
Clinical narrative: No adverse effects; unspecified patients received improperly stored doses of PNEUMOVAX 23; This spontaneous report was received from a medical assistant, referring to a 66-year-old patient of unknown gender. No information regarding the patient's pertinent medical histories, concurrent conditions, concomitant therapies, drug reactions or allergies.  It was reported that on 09-OCT-2019, the vaccine pneumococcal vaccine, polyvalent (23-valent) (PNEUMOVAX23) was exposed to a temperature excursion with a lowest temperature below 36 Fahrenheit (F) degrees (30.5 F degrees) for 10 hours. There was no previous temperature excursions.  On 30-OCT-2019, the patient was vaccinated with the improperly stored pneumococcal vaccine, polyvalent (23-valent) (PNEUMOVAX23) lot # S029265, expiration date 31-MAR-2021 (dose, dose number, route of administration and anatomical injection site were not reported) for prophylaxis. The call was placed because of the Digital Data logger report. No adverse effects reported.  This is one of several reports received from the same reporter. combinationproductreport: Yes; brandname: PNEUMOVAX23 SYRINGE (DEVICE); commondevicename: Pneumococcal Vaccine, Polyvalent (23-valent); productcode: FMF; devicetype: SYRINGE, PISTON (FMF); manufacturername: Merck Sharp & Dohme Corp. ; devicelotnumber: S029265; expirationdate: 31-MAR-2021; deviceage and unit: 0 ; malfunction: Unknown; deviceusage: Unknown; evaluatedbymfr: Not returned to manufacturer; reasonfornoneval: 81 Other; labeledsingleusedevice: No; mdcpreportability: No; mdcpreprationale: Case information does not meet the criteria for Reportability; Sender's Comments:  US-009507513-1911USA001801: US-009507513-2005USA002452: US-009507513-2005USA002453: US-009507513-2005USA002454: US-009507513-2005USA002455: US-009507513-2005USA002456: US-009507513-2005USA002457:
Sex: U
Vaccine: VARCEL
Symptoms: Expired product administered, No adverse event, Product storage error
Clinical narrative: No additional adverse effects reported; A nurse states that on 04/21/2020 an improperly stored expired VARIVAX was administered to a patient; This spontaneous report was received from a nurse referring to a patient of unknown age and gender. The patient's pertinent medical history, drug reactions/allergies, concurrent conditions and concomitant medications ere not reported.     On 21-APR-2020, the patient was vaccinated with improperly stored varicella virus vaccine live (oka/merck)(VARIVAX) lot # S005077 with expiration date 21-FEB-2021, for prophylaxis (dose, route of administration and anatomical location were not reported). No adverse effects were reported. It was stated that the vaccine was exposed to a temperature excursion of 50 Fahrenheit degrees for 40 minutes. No previous expiration date was reported. A digital data logger was involved.
Age: 0.42
Sex: U
Vaccine: RV5
Symptoms: Product administered to patient of inappropriate age
Clinical narrative: No adverse event; the patient was administered the first dose at age 5 months old; This spontaneous report as received from a medical assistant refers to a 5 month old patient of an unknown gender and Race. The patient's concurrent conditions, medical history and concomitant medications were not reported.      On 07-MAY-2020, the 5 month old patient was vaccinated with rotavirus vaccine, live, oral, pentavalent (ROTATEQ) lot # S017642 has been verified to be a valid lot number, expiration date reported 20-FEB-2021, but upon internal validation established as 28-FEB-2021), for prophylaxis (dose and route of administration were not reported) (product administered to patient of inappropriate age).
Age: 85.0
Sex: U
Vaccine: PPV, UNK
Symptoms: No adverse event, Product storage error
Clinical narrative: No adverse effects; unspecified patients received improperly stored doses of PNEUMOVAX 23; This spontaneous report was received from a medical assistant, referring to a 85-year-old patient of unknown gender. No information regarding the patient's pertinent medical histories, concurrent conditions, concomitant therapies, drug reactions or allergies.  It was reported that on 09-OCT-2019, the vaccine pneumococcal vaccine, polyvalent (23-valent) (PNEUMOVAX23) was exposed to a temperature excursion with a lowest temperature below 36 Fahrenheit (F) degrees (30.5 F degrees) for 10 hours. There was no previous temperature excursions.  On 30-OCT-2019, the patient was vaccinated with the improperly stored pneumococcal vaccine, polyvalent (23-valent) (PNEUMOVAX23) lot # S029265, expiration date 31-MAR-2021 (dose, dose number, route of administration and anatomical injection site were not reported) for prophylaxis. The call was placed because of the Digital Data logger report. No adverse effects reported.  This is one of several reports received from the same reporter. combinationproductreport: Yes; brandname: PNEUMOVAX23 SYRINGE (DEVICE); commondevicename: Pneumococcal Vaccine, Polyvalent (23-valent); productcode: FMF; devicetype: SYRINGE, PISTON (FMF); manufacturername: Merck Sharp & Dohme Corp. ; devicelotnumber: S029265; expirationdate: 31-MAR-2021; deviceage and unit: 0 ; malfunction: Unknown; deviceusage: Unknown; evaluatedbymfr: Not returned to manufacturer; reasonfornoneval: 81 Other; labeledsingleusedevice: No; mdcpreportability: No; mdcpreprationale: Case information does not meet the criteria for Reportability; Sender's Comments:  US-009507513-1911USA001801: US-009507513-2005USA002426: US-009507513-2005USA002453: US-009507513-2005USA002454: US-009507513-2005USA002455: US-009507513-2005USA002456: US-009507513-2005USA002457:
Age: 65.0
Sex: U
Vaccine: PPV, UNK
Symptoms: No adverse event, Product storage error
Clinical narrative: No adverse effects; unspecified patients received improperly stored doses of PNEUMOVAX 23; This spontaneous report was received from a medical assistant, referring to a 65-year-old patient of unknown gender. No information regarding the patient's pertinent medical histories, concurrent conditions, concomitant therapies, drug reactions or allergies.  It was reported that on 09-OCT-2019, the vaccine pneumococcal vaccine, polyvalent (23-valent) (PNEUMOVAX23) was exposed to a temperature excursion with a lowest temperature below 36 Fahrenheit (F) degrees (30.5 F degrees) for 10 hours. There was no previous temperature excursions.  On 01-NOV-2019, the patient was vaccinated with the improperly stored pneumococcal vaccine, polyvalent (23-valent) (PNEUMOVAX23) lot # S029265, expiration date 31-MAR-2021 (dose, dose number, route of administration and anatomical injection site were not reported) for prophylaxis. The call was placed because of the Digital Data logger report. No adverse effects reported.  This is one of several reports received from the same reporter. combinationproductreport: Yes; brandname: PNEUMOVAX23 SYRINGE (DEVICE); commondevicename: Pneumococcal Vaccine, Polyvalent (23-valent); productcode: FMF; devicetype: SYRINGE, PISTON (FMF); manufacturername: Merck Sharp & Dohme Corp. ; devicelotnumber: S029265; expirationdate: 31-MAR-2021; deviceage and unit: 0 ; malfunction: Unknown; deviceusage: Unknown; evaluatedbymfr: Not returned to manufacturer; reasonfornoneval: 81 Other; labeledsingleusedevice: No; mdcpreportability: No; mdcpreprationale: Case information does not meet the criteria for Reportability; Sender's Comments:  US-009507513-1911USA001801: US-009507513-2005USA002426: US-009507513-2005USA002452: US-009507513-2005USA002454: US-009507513-2005USA002455: US-009507513-2005USA002456: US-009507513-2005USA002457:
Age: 67.0
Sex: U
Vaccine: PPV, UNK
Symptoms: No adverse event, Product storage error
Clinical narrative: No adverse effects; unspecified patients received improperly stored doses of PNEUMOVAX 23; This spontaneous report was received from a medical assistant, referring to a 67-year-old patient of unknown gender. No information regarding the patient's pertinent medical histories, concurrent conditions, concomitant therapies, drug reactions or allergies.  It was reported that on 09-OCT-2019, the vaccine pneumococcal vaccine, polyvalent (23-valent) (PNEUMOVAX23) was exposed to a temperature excursion with a lowest temperature below 36 Fahrenheit (F) degrees (30.5 F degrees) for 10 hours. There was no previous temperature excursions.  On 31-OCT-2019, the patient was vaccinated with the improperly stored pneumococcal vaccine, polyvalent (23-valent) (PNEUMOVAX23) lot # S029265, expiration date 31-MAR-2021 (dose, dose number, route of administration and anatomical injection site were not reported) for prophylaxis. The call was placed because of the Digital Data logger report. No adverse effects reported.  This is one of several reports received from the same reporter. combinationproductreport: Yes; brandname: PNEUMOVAX23 SYRINGE (DEVICE); commondevicename: Pneumococcal Vaccine, Polyvalent (23-valent); productcode: FMF; devicetype: SYRINGE, PISTON (FMF); manufacturername: Merck Sharp & Dohme Corp. ; devicelotnumber: S029265; expirationdate: 31-MAR-2021; deviceage and unit: 0 ; malfunction: Unknown; deviceusage: Unknown; evaluatedbymfr: Not returned to manufacturer; reasonfornoneval: 81 Other; labeledsingleusedevice: No; mdcpreportability: No; mdcpreprationale: Case information does not meet the criteria for Reportability; Sender's Comments:  US-009507513-1911USA001801: US-009507513-2005USA002426: US-009507513-2005USA002452: US-009507513-2005USA002453: US-009507513-2005USA002455: US-009507513-2005USA002456: US-009507513-2005USA002457:
Age: 68.0
Sex: U
Vaccine: PPV, UNK
Symptoms: No adverse event, Product storage error
Clinical narrative: No adverse effects; unspecified patients received improperly stored doses of PNEUMOVAX 23; This spontaneous report was received from a medical assistant, referring to a 68-year-old patient of unknown gender. No information regarding the patient's pertinent medical histories, concurrent conditions, concomitant therapies, drug reactions or allergies.  It was reported that on 09-OCT-2019, the vaccine pneumococcal vaccine, polyvalent (23-valent) (PNEUMOVAX23) was exposed to a temperature excursion with a lowest temperature below 36 Fahrenheit (F) degrees (30.5 F degrees) for 10 hours. There was no previous temperature excursions.  On 01-NOV-2019, the patient was vaccinated with the improperly stored pneumococcal vaccine, polyvalent (23-valent) (PNEUMOVAX23) lot # S029265, expiration date 31-MAR-2021 (dose, dose number, route of administration and anatomical injection site were not reported) for prophylaxis. The call was placed because of the Digital Data logger report. No adverse effects reported.  This is one of several reports received from the same reporter. combinationproductreport: Yes; brandname: PNEUMOVAX23 SYRINGE (DEVICE); commondevicename: Pneumococcal Vaccine, Polyvalent (23-valent); productcode: FMF; devicetype: SYRINGE, PISTON (FMF); manufacturername: Merck Sharp & Dohme Corp. ; devicelotnumber: S029265; expirationdate: 31-MAR-2021; deviceage and unit: 0 ; malfunction: Unknown; deviceusage: Unknown; evaluatedbymfr: Not returned to manufacturer; reasonfornoneval: 81 Other; labeledsingleusedevice: No; mdcpreportability: No; mdcpreprationale: Case information does not meet the criteria for Reportability; Sender's Comments:  US-009507513-1911USA001801: US-009507513-2005USA002426: US-009507513-2005USA002452: US-009507513-2005USA002453: US-009507513-2005USA002454: US-009507513-2005USA002456: US-009507513-2005USA002457:
Age: 68.0
Sex: U
Vaccine: PPV, UNK
Symptoms: No adverse event, Product storage error
Clinical narrative: No adverse effects; unspecified patients received improperly stored doses of PNEUMOVAX 23; This spontaneous report was received from a medical assistant, referring to a 68-year-old patient of unknown gender. No information regarding the patient's pertinent medical histories, concurrent conditions, concomitant therapies, drug reactions or allergies.  It was reported that on 09-OCT-2019, the vaccine pneumococcal vaccine, polyvalent (23-valent) (PNEUMOVAX23) was exposed to a temperature excursion with a lowest temperature below 36 Fahrenheit (F) degrees (30.5 F degrees) for 10 hours. There was no previous temperature excursions.  On 01-NOV-2019, the patient was vaccinated with the improperly stored pneumococcal vaccine, polyvalent (23-valent) (PNEUMOVAX23) lot # S029265, expiration date 31-MAR-2021 (dose, dose number, route of administration and anatomical injection site were not reported) for prophylaxis. The call was placed because of the Digital Data logger report. No adverse effects reported.  This is one of several reports received from the same reporter. combinationproductreport: Yes; brandname: PNEUMOVAX23 SYRINGE (DEVICE); commondevicename: Pneumococcal Vaccine, Polyvalent (23-valent); productcode: FMF; devicetype: SYRINGE, PISTON (FMF); manufacturername: Merck Sharp & Dohme Corp. ; devicelotnumber: S029265; expirationdate: 31-MAR-2021; deviceage and unit: 0 ; malfunction: Unknown; deviceusage: Unknown; evaluatedbymfr: Not returned to manufacturer; reasonfornoneval: 81 Other; labeledsingleusedevice: No; mdcpreportability: No; mdcpreprationale: Case information does not meet the criteria for Reportability; Sender's Comments:  US-009507513-1911USA001801: US-009507513-2005USA002426: US-009507513-2005USA002452: US-009507513-2005USA002453: US-009507513-2005USA002454: US-009507513-2005USA002455: US-009507513-2005USA002457:
Age: 68.0
Sex: U
Vaccine: PPV, UNK
Symptoms: No adverse event, Product storage error
Clinical narrative: No adverse effects; unspecified patients received improperly stored doses of PNEUMOVAX 23; This spontaneous report was received from a medical assistant, referring to a 68-year-old patient of unknown gender. No information regarding the patient's pertinent medical histories, concurrent conditions, concomitant therapies, drug reactions or allergies.  It was reported that on 09-OCT-2019, the vaccine pneumococcal vaccine, polyvalent (23-valent) (PNEUMOVAX23) was exposed to a temperature excursion with a lowest temperature below 36 Fahrenheit (F) degrees (30.5 F degrees) for 10 hours. There was no previous temperature excursions.  On 01-NOV-2019, the patient was vaccinated with the improperly stored pneumococcal vaccine, polyvalent (23-valent) (PNEUMOVAX23) lot # S029265, expiration date 31-MAR-2021 (dose, dose number, route of administration and anatomical injection site were not reported) for prophylaxis. The call was placed because of the Digital Data logger report. No adverse effects reported.  This is one of several reports received from the same reporter. combinationproductreport: Yes; brandname: PNEUMOVAX23 SYRINGE (DEVICE); commondevicename: Pneumococcal Vaccine, Polyvalent (23-valent); productcode: FMF; devicetype: SYRINGE, PISTON (FMF); manufacturername: Merck Sharp & Dohme Corp. ; devicelotnumber: S029265; expirationdate: 31-MAR-2021; deviceage and unit: 0 ; malfunction: Unknown; deviceusage: Unknown; evaluatedbymfr: Not returned to manufacturer; reasonfornoneval: 81 Other; labeledsingleusedevice: No; mdcpreportability: No; mdcpreprationale: Case information does not meet the criteria for Reportability; Sender's Comments:  US-009507513-1911USA001801: US-009507513-2005USA002426: US-009507513-2005USA002452: US-009507513-2005USA002453: US-009507513-2005USA002454: US-009507513-2005USA002455: US-009507513-2005USA002456:
Sex: U
Vaccine: VARZOS
Symptoms: Influenza like illness
Clinical narrative: flu symptoms that occurred after my first shot (2 days of flu-like symptoms); This case was reported by a consumer and described the occurrence of flu-like symptoms in a 53-year-old patient who received Herpes zoster (Shingrix) for prophylaxis.   On 6th December 2019, the patient received the 1st dose of Shingrix. On an unknown date, less than 4 months after receiving Shingrix, the patient experienced flu-like symptoms. On an unknown date, the outcome of the flu-like symptoms was recovered/resolved.   It was unknown if the reporter considered the flu-like symptoms to be related to Shingrix.  Additional details were provided as follows: The age at vaccination was not reported, but it could be 52 year or 53 year.  The patient stated flu symptoms that occurred after first shot (2 days of flu-like symptoms).
Age: 60.0
Sex: M
Vaccine: VARZOS
Symptoms: Accidental exposure to product, Accidental underdose, Exposure via skin contact, Immediate post-injection reaction, Injection site extravasation
Clinical narrative: some vaccine leaked out of the muscle right after injected; some vaccine leaked out of the muscle right after the patient was injected; some vaccine leaked out of the muscle right after the patient was injected; Inadvertent exposure to vaccine; This case was reported by a pharmacist via call center representative and described the occurrence of injection site leaking in a 60-year-old male patient who received Herpes zoster (Shingrix) (batch number TJ35Z, expiry date 1st December 2021) for prophylaxis.   On 12th February 2020, the patient received the 2nd dose of Shingrix (intramuscular). On 12th February 2020, unknown after receiving Shingrix, the patient experienced accidental underdose, exposure via skin contact and inadvertent exposure to vaccine. On an unknown date, the outcome of the accidental underdose, exposure via skin contact and inadvertent exposure to vaccine were unknown.  Additional details were provided as follows: The batch number for Shingrix was reported as TJ35C. Based on a batch number review the batch number was updated to TJ35Z. Some vaccine of Shingrix leaked out of the muscle right after the patient was injected, which led to accidental underdose, Inadvertent exposure to vaccine and exposure via skin contact The reporter consented to follow up.   Follow up information received from pharmacist on 23rd March 2020: On 12th February 2020, immediately after receiving Shingrix, the patient experienced injection site leaking. the outcome of the injection site leaking was unknown. It was unknown if the reporter considered the injection site leaking to be related to Shingrix. An additional full dose was given as recommended by pharmacist call center representative.
Sex: U
Vaccine: FLUX
Symptoms: Pain in extremity
Clinical narrative: sore arm; This case was reported by a pharmacist via call center representative and described the occurrence of pain in arm in a patient who received Flu Seasonal QIV Dresden (Influenza vaccine Quadrivalent unspecified season) for prophylaxis.   On an unknown date, the patient received Influenza vaccine Quadrivalent unspecified season at an unknown dose. On an unknown date, less than a year after receiving Influenza vaccine Quadrivalent unspecified season, the patient experienced pain in arm. On an unknown date, the outcome of the pain in arm was unknown.   It was unknown if the reporter considered the pain in arm to be related to Influenza vaccine Quadrivalent unspecified season.  Additional details were received as follows: The age at vaccination was not applicable for this report. The reporter stated that, almost everyone complained of a sore arm after Flu shot similar to what people feel after the flu shot. The reporter did not consented to follow up.  The reporter could not provide any additional details regarding patients.  This case was linked with case US2020050262 (Shingrix vaccine case), reported by the same reporter.
Age: 64.0
Sex: M
Vaccine: VARZOS
Symptoms: Injection site pain
Clinical narrative: Pain at injection site; This case was reported by a consumer via call center representative and described the occurrence of injection site pain in a 64-year-old male patient who received Herpes zoster (Shingrix) for prophylaxis.   On 27th November 2019, the patient received the 1st dose of Shingrix (intramuscular). On an unknown date, unknown after receiving Shingrix, the patient experienced injection site pain. On an unknown date, the outcome of the injection site pain was recovered/resolved.   It was unknown if the reporter considered the injection site pain to be related to Shingrix.  Additional details were received as follows: The age at vaccination was not reported. The patient stated, right after getting the first dose of Shingrix he experienced pain at the injection site which lasted for several days. The reporter did not consented to follow up.  No further details were provided.
Age: 68.0
Sex: F
Vaccine: VARZOS
Symptoms: Pain, Pain in extremity, Peripheral swelling
Clinical narrative: soreness and swelling in her arm; body aches; soreness and swelling in her arm; This case was reported by a consumer via call center representative and described the occurrence of general body pain in a 68-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   In February 2020, the patient received the 1st dose of Shingrix (intramuscular). In February 2020, less than a day after receiving Shingrix, the patient experienced general body pain and pain in arm. In March 2020, the patient experienced swelling arm. On an unknown date, the outcome of the general body pain, pain in arm and swelling arm were recovered/resolved.   It was unknown if the reporter considered the general body pain, pain in arm and swelling arm to be related to Shingrix.  Additional details were received as follows: The patient reported that she received the first dose of Shingrix about 1 month ago. She had some body aches, and soreness and swelling in her arm starting the evening of the injection. The reporter consented to follow up.
Age: 68.0
Sex: M
Vaccine: VARZOS, VARZOS
Symptoms: Herpes zoster
Clinical narrative: Shingles; This case was reported by a pharmacist via call center representative and described the occurrence of shingles in a 68-year-old male patient who received Herpes zoster (Shingrix) (batch number N2E73, expiry date 31st March 2022) and (batch number A55XP, expiry date 22nd March 2022) for prophylaxis.   On 12th January 2020, the patient received the 1st dose of Shingrix. On an unknown date, the dose was an unknown dose. On an unknown date, couple of months after receiving Shingrix, the patient experienced shingles. On an unknown date, the outcome of the shingles was recovered/resolved.   It was unknown if the reporter considered the shingles to be related to Shingrix.  Additional details were reported as follows:  The pharmacist reported a patient experienced shingles after dose one of Shingrix.  HCP reports the patient experienced shingles a couple months after receiving dose one, no exact date provides.  HCP reports shingles symptoms resolved as of a week ago.  No exact symptoms reported.  No exact date of resolution provided.  batch and expiration date, one was for powder portion of Shingrix.  Batch and expiration date two are for diluent portion of Shingrix. The reported batch number N2E74 for Shingrix did not exist and was updated to N2E73 as per the sales database.
Age: 63.0
Sex: F
Vaccine: VARZOS
Symptoms: Chills, Fatigue, Migraine
Clinical narrative: migraines; fatigue; chills; This case was reported by a consumer via call center representative and described the occurrence of migraine in a 63-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   On 30th April 2020, the patient received the 1st dose of Shingrix. On 1st May 2020, 1 days after receiving Shingrix, the patient experienced migraine, fatigue and chills. On an unknown date, the outcome of the migraine, fatigue and chills were not recovered/not resolved.   It was unknown if the reporter considered the migraine, fatigue and chills to be related to Shingrix.  Additional details were reported as follows:  Reporter was the daughter of the patient.  Her mother received the first dose of Shingrix the before reporting and has experienced migraines, fatigue and chills on the day of reporting. She did not want to share her email
Age: 70.0
Sex: F
Vaccine: VARZOS, VARZOS, VARZOS, VARZOS, VARZOS, VARZOS, VARZOS, VARZOS, VARZOS, VARZOS
Symptoms: Feeling abnormal, Herpes zoster
Clinical narrative: shingles; were bad; This case was reported by a consumer via call center representative and described the occurrence of shingles in a 70-year-old female patient who received Herpes zoster (Shingrix) (batch number 95XF7, expiry date 31st October 2020) for prophylaxis.   On 31st October 2019, the patient received the 1st dose of Shingrix (intramuscular) .5 ml. In November 2019, 1 week after receiving Shingrix, the patient experienced shingles and feeling bad. On an unknown date, the outcome of the shingles and feeling bad were recovered/resolved.   It was unknown if the reporter considered the shingles and feeling bad to be related to Shingrix.  Additional details were reported as follows:  About one week after receiving dose of Shingrix she developed shingles.  The patient stated they were bad for a week, and then resolved. The reporter consented to follow up. This case has been linked with US2020075700, reported by same reporter.
Age: 70.0
Sex: F
Vaccine: VARZOS, VARZOS, VARZOS, VARZOS, VARZOS, VARZOS, VARZOS, VARZOS, VARZOS, VARZOS
Symptoms: Inflammation, Pruritus, Rash, Rash erythematous, Rash papular
Clinical narrative: shingles; were bad; This case was reported by a consumer via call center representative and described the occurrence of shingles in a 70-year-old female patient who received Herpes zoster (Shingrix) (batch number 95XF7, expiry date 31st October 2020) for prophylaxis.   On 31st October 2019, the patient received the 1st dose of Shingrix (intramuscular) .5 ml. In November 2019, 1 week after receiving Shingrix, the patient experienced shingles and feeling bad. On an unknown date, the outcome of the shingles and feeling bad were recovered/resolved.   It was unknown if the reporter considered the shingles and feeling bad to be related to Shingrix.  Additional details were reported as follows:  About one week after receiving dose of Shingrix she developed shingles.  The patient stated they were bad for a week, and then resolved. The reporter consented to follow up. This case has been linked with US2020075700, reported by same reporter.
Age: 70.0
Sex: F
Vaccine: VARZOS, VARZOS, VARZOS, VARZOS, VARZOS, VARZOS, VARZOS, VARZOS, VARZOS, VARZOS
Symptoms: Feeling abnormal, Herpes zoster
Clinical narrative: A few days after the shot I suddenly noticed a painful outbreak on my right calf. It had raised red bumps and was 8" x 4". The area was itchy, sore, inflamed, and lasted a week. It looked like shingles I saw before. Hot shower water and soap aggravated it. I did not pursue treatment. P.S. Another woman in line with me at the pharmacy reported a similar outbreak.
Age: 70.0
Sex: F
Vaccine: VARZOS, VARZOS, VARZOS, VARZOS, VARZOS, VARZOS, VARZOS, VARZOS, VARZOS, VARZOS
Symptoms: Inflammation, Pruritus, Rash, Rash erythematous, Rash papular
Clinical narrative: A few days after the shot I suddenly noticed a painful outbreak on my right calf. It had raised red bumps and was 8" x 4". The area was itchy, sore, inflamed, and lasted a week. It looked like shingles I saw before. Hot shower water and soap aggravated it. I did not pursue treatment. P.S. Another woman in line with me at the pharmacy reported a similar outbreak.
Sex: F
Vaccine: VARZOS
Symptoms: Rash
Clinical narrative: breakout on her shoulder; This case was reported by a consumer via call center representative and described the occurrence of skin breakout in a female patient who received Herpes zoster (Shingrix) for prophylaxis.   On an unknown date, the patient received the 1st dose of Shingrix. On an unknown date, unknown after receiving Shingrix, the patient experienced skin breakout. On an unknown date, the outcome of the skin breakout was unknown.   It was unknown if the reporter considered the skin breakout to be related to Shingrix.  Additional details were reported as follows:  The age at vaccination was not reported. Caller was a patient reporting an adverse event on behalf of another patient.  The patient states that she was in the pharmacy and a woman in the pharmacy told her that after she received the 1st dose of Shingrix, she developed a breakout on her shoulder. Caller did not have any additional details regarding the event or patient. This case has been linked with US2020075700, reported by same reporter.
Age: 69.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site erythema, Injection site swelling
Clinical narrative: Localized Redness and Swelling around the injection site.  The patient took APAP and was started on Keflex 500mg in case of cellulitis.
Age: 70.0
Sex: M
Vaccine: PNC
Symptoms: Pruritus, Urticaria
Clinical narrative: UrticariaPruritus
Sex: U
Vaccine: MMR
Symptoms: Incorrect dose administered, No adverse event
Clinical narrative: Possibly administering less than recommended doses of M-M-R II; no adverse events; This spontaneous report was received from a pharmacist, refers to unspecified number of patients of unknown ages and gender. The patients' pertinent medical history, concurrent conditions, previous drug reactions/allergies were not reported. The patients' concomitant medications included sterile diluent.  On an unknown date, a nurse had been possibly administering less than recommended doses of measles, mumps, and rubella (wistar ra 27-3) virus vaccine, live (M-M-R II) to an unspecified number of patients. Pharmacist reported that although the nurse was reconstituting with the entire 0.7 ml of the supplied sterile diluent, rather than administering the entire contents of the reconstituted vaccine, the nurse was administering 0.5mL (incorrect dose administered). This was possibly causing less than recommended dosing. No adverse effects reported.
Sex: M
Vaccine: VARZOS
Symptoms: Myalgia, Pyrexia, Vaccine positive rechallenge
Clinical narrative: The patient experienced  fever and muscle pain following dose two of Shingrix; The patient experienced  fever and muscle pain following dose two of Shingrix; This case was reported by a pharmacist via call center representative and described the occurrence of fever in a male patient who received Herpes zoster (Shingrix) (batch number L949T, expiry date 16th April 2022) for prophylaxis.   Previously administered products included Shingrix with an associated reaction of pyrexia (1st dose received on an unknown date, refer case US2020075004).   On 30th April 2020, the patient received the 2nd dose of Shingrix. On 30th April 2020, less than a day after receiving Shingrix, the patient experienced fever and myalgia. Rechallenge with Shingrix was positive. On an unknown date, the outcome of the fever and myalgia were unknown.   It was unknown if the reporter considered the fever and myalgia to be related to Shingrix.  Additional details were reported as follows:  The age at vaccination was not reported. HCP describes the fever and muscle pain following dose two as more severe than the experiences following dose two.  Dose two experiences began the morning after dose two was administered.  The reporter consented to follow up.
Sex: M
Vaccine: VARZOS
Symptoms: Malaise, Pyrexia
Clinical narrative: experienced a fever; experienced a fever and mild illness; This case was reported by a pharmacist via call center representative and described the occurrence of fever in a male patient who received Herpes zoster (Shingrix) for prophylaxis.   On an unknown date, the patient received the 1st dose of Shingrix. On an unknown date, unknown after receiving Shingrix, the patient experienced fever and feeling unwell. On an unknown date, the outcome of the fever and feeling unwell were recovered/resolved.   It was unknown if the reporter considered the fever and feeling unwell to be related to Shingrix.  Additional details were reported as follows:  The age at vaccination was not reported. Pharmacist reported the patient experienced a fever and mild illness following dose one of Shingrix. HCP did not provide lot number and expiration date for dose one of Shingrix.  HCP did not provide patient initials and date of birth. HCP describes fever following dose one as mild, almost not even a fever.  The fever and mild illness went away, no resolution date provided.  For tolerance after 2nd dose refer case, US2020AMR075347.
Age: 51.0
Sex: F
Vaccine: VARZOS
Symptoms: Chills, Feeling hot, Pyrexia
Clinical narrative: fever at 99.8 degrees; Body was hot; Cold chills in lower back; This case was reported by a consumer via call center representative and described the occurrence of fever in a 51-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   On 30th April 2020, the patient received the 2nd dose of Shingrix (intramuscular). On 1st May 2020, 1 days after receiving Shingrix, the patient experienced fever, feeling hot and chills. The patient was treated with ibuprofen (Advil). On an unknown date, the outcome of the fever and feeling hot were recovered/resolved and the outcome of the chills was unknown.   It was unknown if the reporter considered the fever, feeling hot and chills to be related to Shingrix.  Additional details were reported as follows:  Caller was field sales representative reporting adverse event for herself.  She received the second dose of Shingrix vaccine the day before reporting.  On the day of reporting, in the morning the patient woke up with fever at 99.8 degrees and her body was hot.  She took an Advil after which she recovered from fever and hot body feeling.  Now she was experiencing cold chills in the lower back. No further details were provided.  The reporter consented to follow up.
Age: 4.0
Sex: F
Vaccine: DTAPIPV, MMRV
Symptoms: Injection site erythema, Injection site swelling, Injection site warmth
Clinical narrative: Pt. had redness and swelling at injection site, warm to the touch.  No improvement on 5/9, redness spread with more swelling.  Provider started pt. on antibiotic, cephalexin.
Age: 70.0
Sex: M
Vaccine: VARZOS
Symptoms: Immediate post-injection reaction, Pruritus
Clinical narrative: Diffuse itching on his right arm that began right after the inoculation, over the last few months the itching remains primarily on the back of his right hand in a 3"x 3" square pattern and a similar sized area on his forearm.  The itching was at first diffuse but has coalesced down to these two areas.  No rash and no skin marking indicating another cause of the itching.
Age: 60.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site pain, Pain in jaw, Tooth infection
Clinical narrative: Patient  believed she had a infected tooth, but was having pain from injection site up to jaw line.
Age: 76.0
Sex: M
Vaccine: VARZOS, VARZOS
Symptoms: Herpes zoster, Vaccination failure
Clinical narrative: recieved the first Shingrix vaccine was on 7/22/19 and the second dose of the vaccine one 10/17/19. He got the shingles the end of February of this year 2020; He got the shingles the end of February of this year 2020; This case was reported by a pharmacist via call center representative and described the occurrence of vaccination failure in a 76-year-old male patient who received Herpes zoster (Shingrix) (batch number LD3NH, expiry date unknown) for prophylaxis.   Co-suspect products included Herpes zoster (Shingrix) (batch number N9LG3, expiry date 12th November 2021) for prophylaxis.   On 17th October 2019, the patient received the 2nd dose of Shingrix. On 22nd July 2019, the patient received the 1st dose of Shingrix. In February 2020, between 4 and 5 months after receiving Shingrix and between 7 and 8 months after receiving Shingrix, 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 Shingrix and Shingrix.  Additional details were provided as follows: The reporter stated that, after vaccionation with Shingrix, the patient experienced shingles at the end of February 2020. The reporter did not know if this was first case of shingles or not. The reporter consented to follow up.
Sex: F
Vaccine: FLU4
Symptoms: Anaphylactic reaction
Clinical narrative: went into anaphylaxis; This case was reported by a physician via sales rep and described the occurrence of anaphylaxis in a female patient who received Flu Seasonal QIV Quebec (FluLaval Quadrivalent) for prophylaxis.   On an unknown date, the patient received FluLaval Quadrivalent (intramuscular). On an unknown date, unknown after receiving FluLaval Quadrivalent, the patient experienced anaphylaxis (serious criteria GSK medically significant). On an unknown date, the outcome of the anaphylaxis was unknown.   It was unknown if the reporter considered the anaphylaxis to be related to FluLaval Quadrivalent.  Additional information was provided as follows: The age at vaccination was not reported. The patient received a Flulaval injection and went into anaphylaxis. The patient went home but had to have someone sit with her. It was unknown if the patient recovered. The filed representative had no information for lot number of medication. The reporter consented to follow up.
Sex: U
Vaccine: HIBV
Symptoms: Expired product administered, No adverse event
Clinical narrative: expired ActHib vaccine was administered to a patient in error, no adverse event; Initial information was received on 04-May-2020 regarding an unsolicited valid non-serious case from a nurse.  This case involves an adult patient who was administered an expired vaccine HIB (PRP/T) VACCINE [ACT-HIB] (Expired product administered).  Medical history, medical treatment(s), vaccination(s) and family history were not provided.   On 29-Apr-2020, the patient received a dose of suspect HIB (PRP/T) VACCINE (lot number not reported, expiry date: 13-Mar-2020) via unknown route in unknown administration site for prophylactic vaccination  It was a case of an actual medication error due to Expired product administered.  At the time of report, no adverse event was reported.  This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holder's compliance with the requirements set out in Directive 2001/83/EC and Module VI of the Good Pharmacovigilance Practices. The classification as a medical error is in no way intended, nor should it be interpreted or construed as an allegation or claim made by the marketing authorization holder that any third party has contributed to or is to be held liable for the occurrence of this medication error.  There will be no information available on lot number
Age: 0.33
Sex: M
Vaccine: IPV
Symptoms: Expired product administered, No adverse event
Clinical narrative: Expired dose of Ipol was inadvertently administered to a four month old patient/ No AE; Initial information was received on 05-May-2020 regarding an unsolicited valid non-serious case received from a health care professional.  This case involves a four months old male patient who was inadvertently administered a second dose of 0.5 mL of expired vaccine IPV (VERO) [IPOL] (lot P1A461M and expiry date 03-May-2020) via intramuscular route in the left thigh for prophylactic vaccination (expired product administered) on 04-May-2020.  The patient's medical history, past medical treatment(s), vaccination(s) and family history were not provided.  Concomitant vaccinations included DIPHTHERIA VACCINE TOXOID, PERTUSSIS VACCINE ACELLULAR, TETANUS VACCINE TOXOID (DAPTACEL); HIB VACCINE CONJ (TET TOX) (ACTHIB); ROTAVIRUS VACCINE (ROTAVIRUS VACCINE) and PNEUMOCOCCAL VACCINE CONJ 7V (CRM197) (PREVNAR) for Immunisation.  It was an actual medication error case due to expired vaccine used.  At a time of reporting no adverse event reported.  This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holder's compliance with the requirements set out in Directive 2001/83/EC and Module VI of the Good Pharmacovigilance Practices. The classification as a medical error is in no way intended, nor should it be interpreted or construed as an allegation or claim made by the marketing authorization holder that any third party has contributed to or is to be held liable for the occurrence of this medication error