chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Sex: M
Vaccine: HPV9, PPV, TDAP
Symptoms: Headache, Vomiting
Clinical narrative: her cousin's son experienced severe headaches with episodes of vomiting; her cousin's son experienced severe headaches with episodes of vomiting; This spontaneous report was received from a consumer referring to her cousin's son of age 18 to 20. The patient's concomitant medication, pertinent medical history and drug reactions/allergies were unknown.  On an unknown date, the patient was vaccinated with hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast)(GARDASIL 9) (strength, dose, route, lot # and expiration were unknown) for prophylaxis. Other suspect therapies included diphtheria toxoid (+) pertussis acellular vaccine (unspecified) (+) tetanus toxoid (TDAP), and pneumococcal vaccine, polyvalent (23-valent) (manufacturer unknown) (reported as pneumonia vaccine but unsure which one) (strength, dose, route, indication, lot # and expiration were unknown). The patient received the 3 vaccines during an office visit.  On unknown dates, the patient experienced severe headaches with episodes of vomiting. The patient had sought medical attention. It was unknown whether any lab diagnostics or studies were performed or not. It was unknown if the patient received treatment. The outcome of headache and vomiting was reported as recovered. The causality assessment between the events and all suspect vaccines was not reported.
Sex: U
Vaccine: PPV
Symptoms: Expired product administered, No adverse event
Clinical narrative: No adverse symptoms reported; The patient inadvertently received an expired dose of Pneumovax23; This spontaneous report was received from a registered nurse referring to a patient of unknown age and unknown gender. Information about pertinent medical history, drug reactions/allergies and concomitant medication was not reported.  On 01-JUL-2020 the patient was vaccinated with an expired dose of pneumococcal vaccine, polyvalent (23-valent) (PNEUMOVAX23) (1 dosage form, lot # R021045 with expiration date 14-APR-2020, route was not reported) for prophylaxis (expired product administered). No adverse symptoms reported.   combinationproductreport: Yes; brandname: PNEUMOVAX23 SYRINGE (DEVICE); commondevicename: Pneumococcal Vaccine, Polyvalent (23-valent); productcode: FMF; devicetype: SYRINGE, PISTON (FMF); manufacturername: Merck Sharp & Dohme Corp.; manufactureraddress:; manufacturercity:; manufacturerstate:; manufacturercountry:; devicelotnumber: R021045; expirationdate: 14-APR-2020; deviceage and unit: 0 ; malfunction: Unknown; deviceusage: Initial; evaluatedbymfr: Not returned to manufacturer; reasonfornoneval: 81 Other; labeledsingleusedevice: No; mdcpreportability: No; mdcpreprationale: Case information does not meet the criteria for Reportability
Sex: F
Vaccine: HPV9
Symptoms: Human papilloma virus test positive, Papilloma viral infection
Clinical narrative: was diagnosed with HPV 16 last week; This spontaneous report was received from a medical assistant of unknown age referring to herself. The patient's pertinent medical history, concomitant medication and drug reactions or allergies were unknown.   On an unknown date, the patient was vaccinated with hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast) (GARDASIL 9) (dose, dose number, vaccination scheme, lot #, expiration date, route of administration, and anatomical site of vaccination were not provided) for prophylaxis.         On an unknown date in September 2020 (reported as last week), the patient had a human papilloma virus (HPV) test which showed positive for HPV 16 and she was diagnosed with HPV 16 infection. Medical attention was sought. The patient would have a leep procedure next week. The outcome of papilloma viral infection was not resolved.     The causality between papilloma viral infection and hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast)(GARDASIL 9) was not reported.
Sex: U
Vaccine: VARCEL
Symptoms: Product storage error
Clinical narrative: Caller returning call with patient information regarding improperly stored vaccine administration; This spontaneous report was received from an other health professional referring to a patient of unknown age and gender. The patient's medical history, historical drugs, concurrent conditions and concomitant medications were not provided.      On an unknown date, the patient was vaccinated with an improperly stored dose of varicella virus vaccine live (oka/merck)(VARIVAX) lot number S038702, expiration date 01-DEC-2021, 0.5 milliliter (route of administration was not provided) for prophylaxis.      The vaccine had a temperature excursion of -9.5 degrees Celsius for 8 hours and 53 minutes, and -10.1 degrees Celsius for 6 hours and 40 minutes. The excursion was called by a digital data logger. No previous temperature excursions were reported.; Sender's Comments:  US-009507513-2009USA008377:
Sex: U
Vaccine: MMRV
Symptoms: Product storage error
Clinical narrative: Caller returning call with patient information regarding improperly stored vaccine administration; This spontaneous report was received from an other health care professional referring to a patient of unknown age and gender. The patient's medical history, historical drugs, concurrent conditions and concomitant medications were not provided.     On an unknown date, the patient was vaccinated with improperly stored dose of measles, mumps, rubella and varicella (oka-merck) virus vaccine live recombinant human albumin (rHA)(PROQUAD) 0.5 milliliter (mL) (route of administration was not provided), lot number T005406, expiration date 12-AUG-2021, as prophylaxis.    The improperly stored dose experienced a temperature excursion of -9.5 degrees Celsius (C) for 8 hours and 53 minutes, and -10.1 C for 6 hours and 40 minutes, with no previous temperature excursions. The call was due to a digital data logger.
Sex: U
Vaccine: PPV
Symptoms: Expired product administered
Clinical narrative: vaccine administered was expired; This spontaneous report was received from a nurse (LPN) referring to a patient of unknown age and gender. No information was provided regarding the patient's medical history, concurrent conditions, past drug history or concomitant medications.     On 21-SEP-2020, the patient was vaccinated with pneumococcal vaccine, polyvalent (23-valent) (PNEUMOVAX23) prefilled syringe, 0.5 milliliter (route and site of administration were not reported)  lot # S002582, which had expired on 10-AUG-2020 (expired product administered) for prophylaxis.    The outcome of expired product administered was unknown. combinationproductreport: Yes; brandname: PNEUMOVAX23 SYRINGE (DEVICE); commondevicename: Pneumococcal Vaccine, Polyvalent (23-valent); productcode: FMF; devicetype: SYRINGE, PISTON (FMF); manufacturername: Merck Sharp & Dohme Corp ; devicelotnumber: S002582; expirationdate: 10-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
Sex: U
Vaccine: PPV
Symptoms: Expired product administered
Clinical narrative: No additional adverse events reported; A patient received a dose of PNEUMOVAX23 one day past the expiration date; This spontaneous report has been received from a pharmacist referring to a patient of unknown age. Information regarding the patient's medical history, drug reactions or allergies, concurrent conditions and concomitant medications was not provided.      On 18-SEP-2020, the patient was vaccinated with an expired dose of pneumococcal vaccine, polyvalent (23-valent) (PNEUMOVAX23) lot # S026366 with expiration date of 17-SEP-2020 (strength, dose, route, frequency, and anatomical location were not provided) for prophylaxis (expired product administered).  combinationproductreport: Yes; brandname: PNEUMOVAX23 SYRINGE (DEVICE); commondevicename: Pneumococcal Vaccine, Polyvalent (23-valent); productcode: FMF; devicetype: SYRINGE, PISTON (FMF); manufacturername: Merck Sharp & Dohme Corp.; devicelotnumber: S026366; expirationdate: 17-SEP-2020; deviceage and unit: 0 ; malfunction: Unknown; deviceusage: Initial; evaluatedbymfr: Not returned to manufacturer; reasonfornoneval: 81 Other; labeledsingleusedevice: No; mdcpreportability: No; mdcpreprationale: Case information does not meet the criteria for Reportability
Age: 90.0
Sex: M
Vaccine: PNC13
Symptoms: No adverse event, Wrong product administered
Clinical narrative: No further AE/PQC reported.; The patient received PREVNAR 13 a little over a year ago and then again last week. Caller reports that patient should have gotten a dose of PNEUMOV AX 23 last week.; This spontaneous report was received from a pharmacist referring to a 91 years old male patient. Information about concurrent condition, concomitant medication and medical history was not provided.     In approximately September 2019 (reported as a little over a year ago), the patient was vaccinated with pneumococcal 13v conj vaccine (crm197) (PREVNAR 13) (strength, dose, route, lot# and expiration date were unknown) for prophylaxis. On 21-SEP-2020 (also reported as last week, conflict information), the patient received pneumococcal 13v conj vaccine (crm197) (PREVNAR 13) again. It was reported that the patient should have gotten a dose of pneumococcal vaccine, polyvalent (23-valent) (PNEUMOVAX23) last week. No further adverse event (AE)/product quality complaint (PQC) reported. The outcome of the events was unknown.
Sex: U
Vaccine: VARCEL
Symptoms: Product storage error
Clinical narrative: improperly stored vaccine administration in reference to temperature excursion; This spontaneous report was received from an unspecified reporter referring to a currently 1-year-old patient of unknown gender. Information about medical history, concurrent conditions and concomitant therapies was not provided.       On an unknown date, the patient was vaccinated with improperly stored varicella virus vaccine live (oka/merck) (VARIVAX) (0.5 milliliter, lot # S038702, expiration date 01-DEC-2021; route was not reported) for prophylaxis (product storage error). Temperature excursions were -9.5 degree Celsius for 8 hours and 53 minutes; -10.1 degree Celsius for 6 hours and 40 minutes. There was no previous temperature excursion. Data logger was involved.
Sex: U
Vaccine: PPV
Symptoms: Expired product administered, No adverse event
Clinical narrative: No known adverse effects; a patient received an expired dose; This spontaneous report was received from a pharmacist and refers to a patient of unknown age and gender. The patient's concurrent conditions, medical history and concomitant medications were not reported.  On 18-SEP-2020, the patient was vaccinated with an expired dose of pneumococcal vaccine, polyvalent (23-valent) (PNEUMOVAX23) injection, lot # S025133, expiry date 15-SEP-2020 (dose, route of administration and anatomical location were not provided) for prophylaxis. There was no known adverse event. combinationproductreport: Yes; brandname: PNEUMOVAX23 SYRINGE (DEVICE); commondevicename: Pneumococcal Vaccine, Polyvalent (23-valent); productcode: FMF; devicetype: SYRINGE, PISTON (FMF); manufacturername: Merck Sharp & Dohme Corp.; manufactureraddress:; manufacturercity:; manufacturerstate:; manufacturercountry:; devicelotnumber: S025133; expirationdate: 15-SEP-2020; deviceage and unit: 0; malfunction: Unknown; deviceusage: Initial; 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: Product storage error
Clinical narrative: Caller reported an Improperly stored administered PROQUAD; This spontaneous report was received from a nurse, referring to a patient of unknown age and gender. The patient's pertinent medical history, concurrent conditions, previous drug reactions or allergies and concomitant medications were not reported.   On 14-SEP-2020, the patient was vaccinated with an improperly stored dose of Measles, Mumps, Rubella and Varicella (Oka-Merck) Virus Vaccine Live (rHA) (PROQUAD) (strength, vaccination scheme, route of administration and anatomical site of vaccination were not reported; lot number T013540, expiration date 17-OCT-2021) given as prophylaxis.  The vaccine administered experienced a temperature excursion between 6 Fahrenheit (F) and 14 F (Average temperature of 11.7 F) for 25 minutes, as recorded by a data logger. There was no previous temperature excursion reported. No additional information was reported.  This is one of several reports received from the same reporter.; Sender's Comments:  US-009507513-2009USA008941: US-009507513-2009USA008944: US-009507513-2009USA008968: US-009507513-2009USA009041: US-009507513-2009USA009321:
Sex: U
Vaccine: MMRV
Symptoms: Product storage error
Clinical narrative: Caller reported an Improperly stored administered PROQUAD; This spontaneous report has been received from a nurse referring to a patient of unknown age and gender. Information about pertinent medical history, concomitant medication or drug reactions/allergies was not provided.  On 17-SEP-2020, the patient was vaccinated with improperly stored measles, mumps, rubella and varicella (Oka-Merck) virus vaccine live (PROQUAD); lot # T013539, expiration date 17-OCT-2021 (strength, dose and route were not reported) for prophylaxis (product storage error).   The storage temperature of the vaccine was reported as 6 Fahrenheit degrees to 14 Fahrenheit degrees (11.7 Fahrenheit degrees) for a time frame of 25 minutes recorded by a data logger. There was no previous temperature excursion. No product quality complaint involved. The outcome of the event was unknown.
Sex: U
Vaccine: VARCEL
Symptoms: Product storage error
Clinical narrative: a dose of VARlVAX was administered during a temperature excursion; This spontaneous report has been received from a medical assistant referring to a patient of unknown age and gender. Information about pertinent medical history, concomitant medication or drug reactions/allergies was not provided.  On 21-SEP-2020, the patient was administered with a dose of varicella virus vaccine live (Oka/Merck) (VARIVAX) 0.5 ml; lot # T008129, expiration date 06-MAR-2022 (strength and route were not reported) for prophylaxis during a temperature excursion (product storage error).   The storage temperature of the vaccine was reported as 7.8 Fahrenheit degrees for a time frame of 6 hours and 46 minutes without a data logger. There was no previous temperature excursion. No product quality complaint involved. The outcome of the event was unknown.
Sex: U
Vaccine: MMRV
Symptoms: Product storage error
Clinical narrative: Caller reported an Improperly stored administered PROQUAD; This spontaneous report has been received from a physician referring to a patient of unknown age and gender. Information about pertinent medical history, concomitant medication or drug reactions/allergies was not provided.  On 14-SEP-2020, the patient was vaccinated with improperly stored measles, mumps, rubella and varicella (Oka-Merck) virus vaccine live (PROQUAD); lot # T013540, expiration date 17-OCT-2021 (strength, dose and route were not reported) for prophylaxis (product storage error).   The storage temperature of the vaccine was reported as 6 Fahrenheit degrees to 14 Fahrenheit degrees (11.7 Fahrenheit degrees) for a time frame of 25 minutes recorded by a data logger. There was no previous temperature excursion. No product quality complaint involved.
Sex: U
Vaccine: MMRV
Symptoms: Product storage error
Clinical narrative: Caller reported an Improperly stored administered PROQUAD; This spontaneous report has been received from a nurse referring to a patient of unknown age and gender. Information about pertinent medical history, concomitant medication or drug reactions/allergies was not provided.  On 21-SEP-2020, the patient was vaccinated with improperly stored measles, mumps, rubella and varicella (Oka-Merck) virus vaccine live (PROQUAD); lot # T013540, expiration date 17-OCT-2021 (strength, dose and route were not reported) for prophylaxis (product storage error).   The storage temperature of the vaccine was 6 Fahrenheit degrees to 14 Fahrenheit degrees (11.7 Fahrenheit degrees) for a time frame of 25 minutes recorded by a data logger. There was no previous temperature excursion.
Sex: U
Vaccine: RV5
Symptoms: No adverse event, Product storage error
Clinical narrative: Nurse called and reported vaccination to patient with improperly stored vaccine; No additional adverse events reported.; This spontaneous report was received from a registered nurse, referring to a patient of unknown age and gender. The patients' pertinent medical history, previous drug reactions or allergies and concomitant medications were not reported.   On an unknown date, the patient was vaccinated with an improperly stored of rotavirus vaccine, live, oral, pentavalent (ROTATEQ), administered at a dose of 2 milliliters (ml), by oral route (formulation, strength, vaccination scheme, lot number and expiration date were not reported) as prophylaxis. The vaccine administered experienced a temperature of 28 degrees Fahrenheit (F), 33.9F, 50.2F, for a time frame of 7 hours and 10 minutes. There was no previous temperature excursion reported. The report did not involved the data logger. No additional adverse events were reported.   This is one of several reports received from the same reporter.; Sender's Comments:  US-009507513-2009USA009446: US-009507513-2009USA009631: US-009507513-2009USA009674:
Sex: U
Vaccine: HPV9
Symptoms: Incomplete course of vaccination
Clinical narrative: The HCP has a 38 year old who missed 2nd and 3rd doses of GARDASIL 9; Information has been received from a healthcare professional regarding a 38-years-old patient of unknown gender. The patient's medical history, drug allergies, previously drug reactions, concurrent conditions and concomitant medications were not reported.  On an unknown date, the patient was vaccinated with the first dose of hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast) (GARDASIL 9) as prophylaxis (dose, frequency, route of administration, anatomical location, lot number and expiration date were not provided).  On an unknown date, the patient missed her second and third dose of hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast) (GARDASIL 9) (missed dose).
Sex: U
Vaccine: PPV
Symptoms: No adverse event, Product storage error
Clinical narrative: no adverse event; patient received an improperly stored dose of PNEUMOVAX 23; This spontaneous report was received from a nurse, referring a patient of unknown age and gender. The patient's pertinent medical history, current conditions, previous drug reactions or allergies were not reported.  On an unspecified date in August 2020,  the patient was administered improperly stored Pneumococcal Vaccine, Polyvalent (23-valent)(PNEUMOVAX23)  (formulation, strength, dose, vaccination scheme, route of administration and anatomical site of vaccination were not reported, lot number T000702 , which has been verified to be valid, expiration date reported and validated as 01-OCT-2021), as prophylaxis (product storage error). At the reporting time, no adverse events were reported.   The vaccine administered was stored at temperatures that went from above 9 degrees Celsius (C) to 13.4C for a time frame of 51 hours and 36 minutes, as recorded by a data logger. There was no previous temperature excursion.
Sex: U
Vaccine: RV5
Symptoms: Expired product administered, No adverse event
Clinical narrative: No additional AE's were reported; ROTATEQ administered to a patient on 22-SEP-2020 that was expired on 16-SEP-2020; This spontaneous report has been received from a nurse concerning a patient of unknown age and ethnicity. The patient's concurrent conditions, known allergies/reactions, medical history and concomitant medications were not reported.   On 22-SEP-2020, the patient was vaccinated with an expired dose of Rotavirus Vaccine, Live, Oral, Pentavalent (ROTATEQ) 2 mL (vial tube) lot # 1660148 expired on 16-SEP-2020, 1 vaccination time) orally, for prophylaxis. The reporter stated realizing that the vaccine was expired (6 days past) after it was given to the patient; and inquired about any known adverse events (AE's) associated with revaccination, or further recommendations for revaccination with Rotavirus Vaccine, Live, Oral, Pentavalent (ROTATEQ) in order to know how to proceed with the dosage regimen. The patient had an appropriate age (unspecified) at the time of vaccination and no AEs were reported by the patient's family.
Age: 61.0
Sex: F
Vaccine: PPV
Symptoms: Allergy test positive, Allergy to vaccine, Blood test, Flushing, Full blood count
Clinical narrative: She is allergic to PNEUMOVAX 23 vaccine; Tingling; Numbness; Flushed face; This spontaneous report was received from a company representative, reporting on herself, a 61 year old female patient. The patient's concomitant medications included rosuvastatin calcium(CRESTOR), famotidine(PEPCID), montelukast sodium(SINGULAIR) and fexofenadine hydrochloride(ALLEGRA). The patient's pertinent medical history included anaphylaxis shock in January 2020, the cause was unknown, but might have been the intravenous (IV) dye, azithromycin (Z-PAK) or ceftriaxone (ROCEPHIN). The patient underwent a computed tomography (CT) scan.  On 16-JUN-2020 the patient was vaccinated with a dose of pneumococcal vaccine, polyvalent (23-valent)(PNEUMOVAX23), intramuscular for vaccination (dose, frequency, anatomical location, lot number and expiration date were not provided). On the same day, within 20 minutes after she received the vaccines, she noticed tingling (paraesthesia), numbness (hypoaesthesia) and a flushed face. She was still in the provider's office when the reaction occurred. The provider gave her fexofenadine (ALLEGRA) and was sent home. The patient reported she cleared up the same day.  On 22-SEP-2020, her provider did a "challenge test" on her and confirmed she was allergic to pneumococcal vaccine, polyvalent (23-valent)(PNEUMOVAX23) vaccine. Other laboratory diagnostics/studies performed were mediator test blood draw and complete blood count (CBC).  The outcome of paraesthesia, flushing and hypoaesthesia was reported as resolved. The outcome of allergy to vaccine was unknown. The causal relationship between therapy with Pneumococcal Vaccine, Polyvalent (23-valent)(PNEUMOVAX23) and paraesthesia, flushing and hypoaesthesia was not provided. The reporter considered allergy to vaccine to be related to Pneumococcal Vaccine, Polyvalent (23-valent)(PNEUMOVAX23).
Age: 61.0
Sex: F
Vaccine: PPV
Symptoms: Hypoaesthesia, Paraesthesia
Clinical narrative: She is allergic to PNEUMOVAX 23 vaccine; Tingling; Numbness; Flushed face; This spontaneous report was received from a company representative, reporting on herself, a 61 year old female patient. The patient's concomitant medications included rosuvastatin calcium(CRESTOR), famotidine(PEPCID), montelukast sodium(SINGULAIR) and fexofenadine hydrochloride(ALLEGRA). The patient's pertinent medical history included anaphylaxis shock in January 2020, the cause was unknown, but might have been the intravenous (IV) dye, azithromycin (Z-PAK) or ceftriaxone (ROCEPHIN). The patient underwent a computed tomography (CT) scan.  On 16-JUN-2020 the patient was vaccinated with a dose of pneumococcal vaccine, polyvalent (23-valent)(PNEUMOVAX23), intramuscular for vaccination (dose, frequency, anatomical location, lot number and expiration date were not provided). On the same day, within 20 minutes after she received the vaccines, she noticed tingling (paraesthesia), numbness (hypoaesthesia) and a flushed face. She was still in the provider's office when the reaction occurred. The provider gave her fexofenadine (ALLEGRA) and was sent home. The patient reported she cleared up the same day.  On 22-SEP-2020, her provider did a "challenge test" on her and confirmed she was allergic to pneumococcal vaccine, polyvalent (23-valent)(PNEUMOVAX23) vaccine. Other laboratory diagnostics/studies performed were mediator test blood draw and complete blood count (CBC).  The outcome of paraesthesia, flushing and hypoaesthesia was reported as resolved. The outcome of allergy to vaccine was unknown. The causal relationship between therapy with Pneumococcal Vaccine, Polyvalent (23-valent)(PNEUMOVAX23) and paraesthesia, flushing and hypoaesthesia was not provided. The reporter considered allergy to vaccine to be related to Pneumococcal Vaccine, Polyvalent (23-valent)(PNEUMOVAX23).
Age: 77.0
Sex: M
Vaccine: VARZOS
Symptoms: Herpes zoster
Clinical narrative: shingles, including any and all of its sequelae.; as well as other severe and personal injuries/Shingles and other related health complications; This initial spontaneous report was received from a lawyer regarding a case in litigation and refers to a 77-year-old male patient. Information about the patient's concurrent condition, concomitant medication or medical history was not provided. On 27-SEP-2016, the patient was vaccinated with zoster vaccine live(ZOSTAVAX) (strength, dose, route, lot # and expiration date were not reported) at a pharmacy for prophylaxis. As a result of his receipt of zoster vaccine live(ZOSTAVAX), on 02-MAY-2017, he was caused to suffer shingles, including any and all of its sequelae. The patient was caused to suffer serious and dangerous side effects including shingles, as well as other severe and personal injuries which were permanent and lasting in nature, physical pain and mental anguish, including diminished enjoyment of life, as well as the need for lifelong medical treatment, monitoring and/or medications. The patient claimed that he suffered shingles and other related health complications. In addition, he required and will continue to require healthcare and services. Plaintiff has incurred and will continue to incur medical and related expenses. He also has suffered and will continue to suffer diminished capacity for the enjoyment of life, a diminished quality of life, increased risk of premature death, aggravation of preexisting conditions, activation of latent conditions, and other losses and damages. His direct medical losses and costs included physician care, monitoring, and treatment. Plaintiff has incurred and will continue to incur mental and physical pain and suffering. The outcome of the events was considered as not recovered. The reporter considered the events to be related to Zoster Vaccine Live(ZOSTAVAX).  The events shingles and other severe and personal injuries/ other related health complications were assessed as serious due to disability.
Sex: U
Vaccine: VARZOS
Symptoms: Herpes zoster, Varicella zoster pneumonia
Clinical narrative: zoster related pneumonia; zoster related pneumonia; This initial spontaneous report was received from a lawyer regarding a case in litigation and refers to a patient of unspecified age and gender. Information about the patient's concurrent condition, concomitant medication or medical history was not provided. On or about 09-SEP-2014, the patient was vaccinated with zoster vaccine live(ZOSTAVAX) (strength, dose, route, lot # and expiration date were not reported) by a healthcare provider for the long-term prevention of shingles and/or zoster-related conditions (prophylaxis). On an unspecified date (reported as subsequent to patient's zoster vaccine live(ZOSTAVAX) inoculation), the patient was treated by a healthcare provider at a hospital for zoster related pneumonia (varicella zoster pneumonia and herpes zoster). As a direct and proximate result of patient's use of the zoster vaccine live(ZOSTAVAX) vaccine, patient has and will continue suffer 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. The outcome of the events was considered as not recovered. The reporter considered the events to be related to Zoster Vaccine Live(ZOSTAVAX).  Upon internal review, varicella zoster pneumonia was determined to be medically significant.
Age: 73.0
Sex: M
Vaccine: VARZOS
Symptoms: Herpes zoster
Clinical narrative: Patient presented with shingles on 9/18/20 at medical office.; This case was reported by a nurse via sales rep and described the occurrence of shingles in a 73-year-old male patient who received Herpes zoster (Shingrix) for prophylaxis.   On 8th September 2020, the patient received the 1st dose of Shingrix. On 18th September 2020, 10 days after receiving Shingrix, 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 Shingrix.  Additional details were provided as follows: After receiving Shingrix, the patient was presented with shingles.
Age: 3.0
Sex: M
Vaccine: DTAP
Symptoms: Aphasia, Speech disorder
Clinical narrative: Stopped talking; This case was reported by a consumer via interactive digital media and described the occurrence of speech disorder in a 3-year-old male patient who received DTPa (DTaP vaccine) for an unknown indication.   On an unknown date, the patient received DTaP vaccine at an unknown dose. On an unknown date, less than a day after receiving DTaP vaccine, the patient experienced speech disorder. On an unknown date, the outcome of the speech disorder was unknown.   It was unknown if the reporter considered the speech disorder to be related to DTaP vaccine.  Additional details were provided as follows: The reporter was the patient's parent. Within 24 hours after receiving DTaP vaccine, the patient stopped talking.
Sex: U
Vaccine: FLUX
Symptoms: Guillain-Barre syndrome
Clinical narrative: gbs; This case was reported by a consumer via interactive digital media and described the occurrence of guillain barre syndrome 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. On an unknown date, unknown after receiving Influenza vaccine Quadrivalent unspecified season, the patient experienced guillain barre syndrome (serious criteria hospitalization, GSK medically significant and life threatening). On an unknown date, the outcome of the guillain barre syndrome was unknown.   It was unknown if the reporter considered the guillain barre syndrome to be related to Influenza vaccine Quadrivalent unspecified season.  Additional details were provided as follows: The reporter was reported for himself/herself. In 2004, the patient got guillain barre syndrome in 2004 and stayed in hospital for 5 and half months. The reporter stated that, the lord spread his/her life after going on ventilator for 2 weeks.
Sex: M
Vaccine: VARZOS
Symptoms: Injection site erythema
Clinical narrative: skin redness localized to area where the vaccine was given. / size of a palm of the hand.; This case was reported by a pharmacist via call center representative and described the occurrence of injection site erythema in a male patient who received Herpes zoster (Shingrix) for prophylaxis.   On an unknown date, the patient received Shingrix. On an unknown date, unknown after receiving Shingrix, the patient experienced injection site erythema. On an unknown date, the outcome of the injection site erythema was unknown.   It was unknown if the reporter considered the injection site erythema to be related to Shingrix.  Additional details were provided as follows: The age at vaccination was not reported. The pharmacist reported that about 2-3 years ago the patient received Shingrix and he developed skin redness localized to the area where the vaccine was given (shoulder area). It was the size of a palm of the hand. The reporter did not consent to follow up. No further details were available since it had happened so long ago. No need to follow up with RPH since she stated she had no further details. This is 1 of the 4 link cases, reported by same reporter.; Sender's Comments:  US-GLAXOSMITHKLINE-US2020187932:Same Reporter US-GLAXOSMITHKLINE-US2020187931:Same Reporter US-GLAXOSMITHKLINE-US2020187917:same reporter
Age: 70.0
Sex: F
Vaccine: FLU4
Symptoms: Stress fracture
Clinical narrative: stress fracture in her foot; Initial information was received on 21-Sep-2020 regarding an unsolicited valid non-serious case from a consumer/non-health care professional.  This case involves a 70 year old female patient who had a stress fracture in her foot (stress fracture), while she received vaccine INFLUENZA QUADRIVAL A-B HIGH DOSE HV VACCINE [FLUZONE HIGH-DOSE QUADRIVALENT].  Medical history, medical treatment(s), vaccination(s) and family history were not provided.  The patient did not receive any concomitant medications   On 15-Sep-2020, the patient received a 0.5 ml dose of suspect INFLUENZA QUADRIVAL A-B HIGH DOSE HV VACCINE (lot number not reported) once via intramuscular route in unknown administration site for prophylactic vaccination.  On 18-Sep-2020, the patient developed a non-serious stress fracture in her foot (stress fracture) 3 days following the administration of INFLUENZA QUADRIVAL A-B HIGH DOSE HV VACCINE.  No laboratory data was provided.  The physician gave the patient methylprednisolone, a daily tapering dose, starting at 24 mg and then decreasing by 4 mg daily for 6 days, to treat the stress fracture. The patient picked up the methylprednisolone over the weekend, but has not started taking it yet, because she read that there can be an interaction between Fluzone High-Dose vaccine and methylprednisolone, that if methylprednisolone is taken within 2 weeks of getting the flu vaccine, in could decrease the effectiveness of the flu vaccine.  At the time of report, the outcome of events was unknown.  There will be no information available on lot number
Age: 15.0
Sex: M
Vaccine: FLUR4
Symptoms: No adverse event, Product administered to patient of inappropriate age
Clinical narrative: A dose of FLUBLOK was inadvertently administered to a 15-year-old patient, no AE~; Initial information was received on 17-Sep-2020 regarding an unsolicited valid non-serious case from a nurse.  This case involves a 15 years old male patient who was inadvertently administered INFLUENZA QUADRIVALENT RECOMBINANT VACCINE [FLUBLOK QIV] (Product administered to patient of inappropriate age)  Medical history, medical treatment(s), vaccination(s) and family history were not provided.  The patient had no other vaccines   On 17-Sep-2020, the patient received a 0.5 ml dose of suspect INFLUENZA QUADRIVALENT RECOMBINANT VACCINE (lot QFAA2013, expiry date: 30-Jun-2021, Strength: standard) once via intramuscular route in the deltoid NOS for prophylactic vaccination.  It was a case of an actual medication error due to Inappropriate age at vaccine administration (latency same day).  No adverse reaction 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
Sex: U
Vaccine: FLU4
Symptoms: Product storage error
Clinical narrative: Fluzone Quadrivalent was in transit for too long but had already given to five patients/No AE; Initial information was received on 21-Sep-2020 regarding an unsolicited valid non-serious case received from an other health professional (medical assistant). This case involves five patients who received FLUZONE QUADRIVALENT (lot UJ446AA and 18-Mar-2021) which was in transit for too long via unknown route at an unknown administration site for prophylactic vaccination (product storage error). The patient's medical history, past medical treatment(s), vaccination(s), family history and concomitant medications were not provided. It is a case of potential medication error due to incorrect storage of drug. 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.
Sex: U
Vaccine: FLU4, FLUX
Symptoms: No adverse event, Wrong product administered
Clinical narrative: patient received a 0.5 ml normal flu vaccine instead of 0.7 Fluzone HD, no AE; Initial information received on 21-Sep-2020 regarding an unsolicited valid non-serious case from pharmacist.  This case involves patient (unknown demographics) who was vaccinated with 0.5 ml normal INFLUENZA VACCINE (lot number and expiration date were not reported) instead of 0.7 (units unspecified) of INFLUENZA QUADRIVAL A-B HIGH DOSE HV VACCINE [FLUZONE HIGH-DOSE QUADRIVALENT] (lot number and expiration date were not reported) via unknown route in an unknown administration site for prophylactic vaccination on an unspecified date (PT: wrong product administered).  The patient's medical history and concomitant medications were not reported.  It was an actual medication error case due to wrong vaccine administered (same day latency).  No adverse event reported at the time of reporting.  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 on the batch number for this case.
Age: 54.0
Sex: F
Vaccine: FLU4
Symptoms: Incorrect dose administered, No adverse event, Product administered to patient of inappropriate age
Clinical narrative: 54 year old patient inadvertently received FLUZONE HD QUADRIVALENT, no  AE; 54 year old patient inadvertently received FLUZONE HD QUADRIVALENT, no  AE; Initial information received on 21-Sep-2020 regarding an unsolicited valid non-serious case from a other health professional.  This case involves a 54 years old female patient inadvertently received 0.7 ml of INFLUENZA QUADRIVAL A-B HIGH DOSE HV VACCINE [FLUZONE HIGH-DOSE QUADRIVALENT] (lot number UJ467AB and expiration date:30-Jun-2021) via intramuscular route in the right deltoid for prophylactic vaccination on 21-Sep-2020 (PT: product administered to patient of inappropriate age, wrong product administered)  Medical history was not reported.  Concomitant medications were not given to patient.  It was an actual medication error case due to inappropriate age at vaccine administration and wrong vaccine administered (same day latency).   No adverse event reported at the time of reporting.  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.
Age: 70.0
Sex: F
Vaccine: FLU4
Symptoms: Chills, Headache, Nausea, Pyrexia
Clinical narrative: nausea; a dull headache; chills; fever; Initial information received on 21-Sep-2020 regarding an unsolicited valid non-serious case from a consumer/non-health care professional.  This case involves a 70 years old female patient who experienced nausea, a dull headache (headache), chills and fever (pyrexia), while she received vaccine INFLUENZA QUADRIVAL A-B HIGH DOSE HV VACCINE [FLUZONE HIGH-DOSE QUADRIVALENT].  Medical history, medical treatment(s), vaccination(s), concomitant medication(s) and family history were not provided.   On an unknown date, the patient received a dose of suspect INFLUENZA QUADRIVAL A-B HIGH DOSE HV VACCINE (lot number and expiration date not reported) via unknown route in unknown administration site for prophylactic vaccination.  On an unknown date, the patient developed non-serious events of  nausea, a dull headache (headache), chills and fever (pyrexia) on the same night, following the administration of INFLUENZA QUADRIVAL A-B HIGH DOSE HV VACCINE.  No laboratory data reported.  It was not reported if the patient received a corrective treatment.  The patient recovered from all the events on the same night in the AM (anti meridian).  There will be no information on the batch number for this case.
Sex: M
Vaccine: FLUR4
Symptoms: Pyrexia
Clinical narrative: fever; Initial information was received on 20-Sep-2020 regarding an unsolicited valid non-serious case from a patient via email.  This case involves a male patient (age was not reported) who experienced fever (pyrexia), while he received vaccine INFLUENZA QUADRIVALENT RECOMBINANT VACCINE [FLUBLOK QIV].   The patient's medical history, past medical treatment(s), vaccination(s), family history and concomitant medications were not provided.   On 15-Sep-2020, the patient received a dose of suspect INFLUENZA QUADRIVALENT RECOMBINANT VACCINE (batch number and other dosing details were not reported) for prophylactic vaccination.  On 22-Sep-2020, the patient developed non-serious fever (pyrexia), 7 days following the administration of INFLUENZA QUADRIVALENT RECOMBINANT VACCINE.  The patient was visited to emergency room for this event.  From 22-Sep-2020, body temperature ranging from 101.8-100.7.  The patient received corrective treatment with Tylenol (Paracetamol) and Ibuprofen.  At the time of reporting, the patient had not recovered from the event.  There will be no information available on the batch number for this case.
Age: 49.0
Sex: F
Vaccine: FLUN4
Symptoms: Arthralgia, Chest discomfort, Chills, Cough, Fatigue
Clinical narrative: Wheezing within a few minutes of delivery, wheezing continues as of 9-28. Sore throat, nasal congestion, nausea, vomiting, sore joints and muscles, fatigue, fevers (intermittent 100.5 to 101.5). Chills, headache, cough, Heavy chest  to take a deep breath.
Age: 49.0
Sex: F
Vaccine: FLUN4
Symptoms: Headache, Myalgia, Nasal congestion, Nausea, Oropharyngeal pain
Clinical narrative: Wheezing within a few minutes of delivery, wheezing continues as of 9-28. Sore throat, nasal congestion, nausea, vomiting, sore joints and muscles, fatigue, fevers (intermittent 100.5 to 101.5). Chills, headache, cough, Heavy chest  to take a deep breath.
Age: 49.0
Sex: F
Vaccine: FLUN4
Symptoms: Pyrexia, Vomiting, Wheezing
Clinical narrative: Wheezing within a few minutes of delivery, wheezing continues as of 9-28. Sore throat, nasal congestion, nausea, vomiting, sore joints and muscles, fatigue, fevers (intermittent 100.5 to 101.5). Chills, headache, cough, Heavy chest  to take a deep breath.
Age: 6.0
Sex: F
Vaccine: FLU4
Symptoms: Hypotonia, Unresponsive to stimuli
Clinical narrative: Patient became very limp on the table and slid down and took 30 sec for patient to respond. When patient responded she did not know where she was but knew birth date and full name.
Age: 9.0
Sex: F
Vaccine: FLU4
Symptoms: Fall, Gaze palsy, Head injury, Muscle contracture, Seizure
Clinical narrative: As the patient was checking out with mom, she fell back and hit her head. and  appeared to start seizing and her eyes went to the back of her head and her body started to contract and started to shake in tremors for 10 seconds . Doctor was notified and pt was monitored.
Age: 9.0
Sex: F
Vaccine: FLU4
Symptoms: Tremor
Clinical narrative: As the patient was checking out with mom, she fell back and hit her head. and  appeared to start seizing and her eyes went to the back of her head and her body started to contract and started to shake in tremors for 10 seconds . Doctor was notified and pt was monitored.
Age: 12.0
Sex: F
Vaccine: MNQ, TDAP
Symptoms: Erythema multiforme, Rash erythematous
Clinical narrative: Patient began with erythematous blanchable rash 9/26.  Benadryl was administered which helped, but symptoms returned and worsened.  Diagnosed in emergency room with Erythema Multiforme
Age: 3.0
Sex: F
Vaccine: FLUR4
Symptoms: No adverse event, Product administered to patient of inappropriate age
Clinical narrative: Flublok vaccine given to 3 year old child.  No adverse effects noted at this time.
Sex: M
Vaccine: PPV
Symptoms: Expired product administered, No adverse event
Clinical narrative: no adverese events; patient received an expired dose; This spontaneous report as received from a pharmacist refers to a male patient of unknown age. The patient's concurrent conditions and medical history were not reported.  On 04-SEP-2020, the patient was vaccinated with an expired dose of pneumococcal vaccine, polyvalent (23-valent) (PNEUMOVAX23) lot # R027299, expiration date 09-APR-2020 (dose, route and site of administration were not reported) for prophylaxis. No additional adverse event was reported.  The vaccine did not undergo any temperature excursion prior to being administered.
Sex: U
Vaccine: MMR, VARCEL
Symptoms: No adverse event, Product storage error
Clinical narrative: Nurse called and reported administration to patient with improperly stored vaccines; This spontaneous report was received from a registered nurse referring to a currently 1-year old patient of unknown gender.  The patient's medical history, concurrent condition and concomitant medication were not provided.     On an unknown date, the patient was vaccinated with improperly stored dose of varicella virus vaccine live (oka/merck) (VARIVAX) (dose: 0.5 milliliter (ml), lot # S038178, expiration date 26-NOV-2021; strength, route was not provided) and measles, mumps, and rubella (wistar ra 27-3) virus vaccine, live (albumin status of rHA (recombinant human albumin)) (M-M-R II) (dose: 0.5 ml, lot# S020962, expiration date 07-JUL-2021; strength and route were unknown) for prophylaxis (product storage error).   Temperature excursion of these vaccines was 11 Fahrenheit degrees for 3 hours and 29 minutes. There was no previous temperature excursion. No additional adverse event was reported. Data logger was not involved.  This is one of several reports received from the same reporter.; Sender's Comments:  US-009507513-2009USA009426:01724666, US-009507513-2009USA009631: US-009507513-2009USA009446: US-009507513-2009USA009550: