chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 1.0
Sex: M
Vaccine: HEPA
Symptoms: No adverse event, Product storage error
Clinical narrative: No adverse event; The patient was administered with improperly stored VAQTA; This spontaneous report was received from a certified medical assistant (CMA) referring to a 12-month-old male patient.  No information regarding the patient's pertinent medical history, drug reactions or allergies and concomitant medications was provided.  On 22-OCT-2019, the patient was vaccinated with improperly stored hepatitis a vaccine, inactivated (VAQTA) (lot # S007770, expiration date: 24-JUL-2020, strength, dose number, anatomical location and route of administration were not reported) for prophylaxis (product storage error). It was reported that the vaccine was exposed to the temperature above 47 degrees Fahrenheit/9 degree Celsius (9.3 Celsius) for 23 minutes. The previous temperature excursion were at the temperature above 47 degrees Fahrenheit/9 degree Celsius (10.7 Celsius) for 33 minutes, at the temperature above 47 degrees Fahrenheit/9 degree Celsius (8.7 Celsius) for 36 minutes, at the temperature above 47 degrees Fahrenheit/9 degree Celsius (8.9 Celsius) for 15 minutes and at the temperature above 47 degrees Fahrenheit/9 degree Celsius (9 Celsius) for 12 minutes. The call was because of a data logger. No adverse event was reported.  This is one of several reports received from the same reporter. combinationproductreport: Yes; brandname: VAQTA SYRINGE (DEVICE); commondevicename: Hepatitis A Vaccine, Inactivated; productcode: FMF; devicetype: SYRINGE, PISTON (FMF); manufacturername: Merck Sharp & Dohme Corp.; devicelotnumber: S007770; expirationdate: 24-JUL-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-009507513-1910USA012749:
Sex: U
Vaccine: RV5
Symptoms: Product storage error
Clinical narrative: No additional adverse event; the patient was inadvertently administered a dose of ROTATEQ on 4/2712020 that had been improperly stored; This spontaneous report was received from a certified medical assistant and refers to a patient of unknown age and gender.  The patient's concomitant therapies, concurrent conditions and medical history were not provided.  On 27-APR-2020, the patient was vaccinated with an improperly stored dose of rotavirus vaccine, live, oral, pentavalent(ROTATEQ) orally, lot # 1660947, expiration date 16-FEB-202,1 for prophylaxis.        Temperature: 47.7F Time frame: 12 MINUTES Previous temperature excursion? 58.3F 14 HOURS Was call because ofa "data logger"? YES
Age: 1.0
Sex: U
Vaccine: HEPA
Symptoms: Expired product administered, No adverse event
Clinical narrative: No additional adverse event; a patient was administered an expired VAQTA; This spontaneous report as received from a nurse refers to a 12-month-old patient of unknown gender. No information regarding the patient's pertinent medical history, concomitant medications, drug reactions and allergies was provided.  On 04-MAY-2020, the patient was vaccinated with an expired dose of hepatitis a vaccine, inactivated (VAQTA) injection, lot # S002507, expiration date 04-APR-2020 (dose and route of administration were not reported) for prophylaxis. No additional adverse effects were reported.
Sex: U
Vaccine: VARZOS
Symptoms: Herpes zoster
Clinical narrative: shingles; Information has been received from a lawyer concerning a case in litigation and refers to a patient of an unknown age and gender. No information regarding the patient's medical history, concurrent conditions and concomitant medications was reported. In 2016, the patient was inoculated with zoster vaccine live (ZOSTAVAX) vaccine (dose, route, vaccination site, lot # and expiry date were not specified) for the long-term prevention of shingles and zoster-related conditions, as prescribed and/or administered by a healthcare provider. On an unknown date, subsequent to zoster vaccine live (ZOSTAVAX) inoculation, the patient was treated by a healthcare provider for shingles. As a direct and proximate result of the patient's use of the zoster vaccine live (ZOSTAVAX) vaccine, the patient has and would continue to 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 event was unknown. The causality was related.
Sex: U
Vaccine: VARZOS
Symptoms: Herpes zoster
Clinical narrative: shingles; Information has been received from a lawyer concerning a case in litigation and refers to a patient of an unknown age and gender. No information regarding the patient's medical history, concurrent conditions and concomitant medications was reported. In 2018, the patient was inoculated with zoster vaccine live (ZOSTAVAX) vaccine (dose, route, vaccination site, lot # and expiry date were not specified) for the long-term prevention of shingles and zoster-related conditions, as prescribed and/or administered by a healthcare provider at a hospital. On an unknown date, subsequent to zoster vaccine live (ZOSTAVAX) inoculation, the patient was treated by a healthcare provider for shingles. As a direct and proximate result of the patient's use of the zoster vaccine live (ZOSTAVAX) vaccine, the patient has and would continue to 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 would continue to suffer such losses, and damages in the future. The outcome of the event was unknown. The causality was related.
Sex: U
Vaccine: VARZOS
Symptoms: Herpes zoster
Clinical narrative: shingles; Information has been received from a lawyer concerning a case in litigation and refers to a patient of an unknown age and gender. No information about the patient's medical history, concurrent conditions and concomitant medications was reported. In 2015, the patient was inoculated with zoster vaccine live(ZOSTAVAX) injection (dose, route of administration, vaccination site, lot # and expiry date were not specified) as prescribed and/or administered by a healthcare provider at the medical office for the long-term prevention of shingles and/or zoster-related conditions. Subsequent to the patient's zoster vaccine live (ZOSTAVAX) inoculation, the patient  was treated by a healthcare provider at the medical office for shingles. As a direct and proximate result of Plaintiffs use of the zoster vaccine live (ZOSTAVAX) vaccine, the patient has and would continue to 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 event was unknown. The causality was related.
Sex: F
Vaccine: VARZOS
Symptoms: Adverse event, Injection site reaction
Clinical narrative: had unspecified injection side reactions; had unspecified injection side reactions and unspecified side effects after a Shingrix injection; This case was reported by a consumer via call center representative and described the occurrence of injection site reaction in a female patient who received Herpes zoster (Shingrix) for prophylaxis.   On an unknown date, the patient received Shingrix at an unknown dose. On an unknown date, unknown after receiving Shingrix, the patient experienced injection site reaction and adverse event. On an unknown date, the outcome of the injection site reaction and adverse event were unknown.   It was unknown if the reporter considered the injection site reaction and adverse event to be related to Shingrix.  Additional details were reported as follows: The age at vaccination was not reported. The patient experienced unspecified injection side reactions and unspecified side effects after a Shingrix injection. The reporter did not consent to follow up. This case is 1 of the 4 cases, reported by same reporter.
Sex: U
Vaccine: VARZOS
Symptoms: Adverse event, Injection site reaction
Clinical narrative: had unspecified injection side reactions; had unspecified injection side reactions and unspecified side effects after a Shingrix injection; This case was reported by a consumer via call center representative and described the occurrence of injection site reaction in a patient who received Herpes zoster (Shingrix) for prophylaxis.   On an unknown date, the patient received Shingrix at an unknown dose. On an unknown date, unknown after receiving Shingrix, the patient experienced injection site reaction and adverse event. On an unknown date, the outcome of the injection site reaction and adverse event were unknown.   It was unknown if the reporter considered the injection site reaction and adverse event to be related to Shingrix.  Additional details were reported as follows: The age at vaccination was not reported. The patient experienced unspecified injection side reactions and unspecified side effects after a Shingrix injection. The reporter did not consent to follow up. This case is 1 of the 4 cases, reported by same reporter.
Sex: F
Vaccine: VARZOS
Symptoms: Adverse event
Clinical narrative: Unspecified adverse event; This case was reported by a lawyer and described the occurrence of adverse event in a female patient who received Herpes zoster (Shingrix) for prophylaxis.   The initial information was received on 30 April 2020 via medical record. As per record the patient had prescribed with Shingrix 50MCG Injection intramuscular single dose vial, she administered 0.5ml in the muscle. On an unknown date, the patient experience unspecified event.
Age: 1.08
Sex: M
Vaccine: HEPA, HIBV, MMRV, PNC13
Symptoms: Erythema, Rash, Rash erythematous, Urticaria
Clinical narrative: patient developed area of redness on right cheek initially then had red spots in his diaper area.  Has progressed to bilateral cheek redness, trunk rash and hives.
Age: 5.0
Sex: F
Vaccine: DTAPIPV
Symptoms: Injection site erythema
Clinical narrative: Redness at site started 1 day after vaccine, spread down arm to above elbow. Worsened for 3-4 days and slowly resolved. Almost entirely resolved by today, day 7. Treated with ice and benadryl. No other system manifestations
Age: 16.0
Sex: M
Vaccine: HEPA
Symptoms: No adverse event, Product storage error
Clinical narrative: No adverse event; The patient was administered with improperly stored VAQTA; This spontaneous report was received from a certified medical assistant (CMA) referring to a 16-year-old male patient.  No information regarding the patient's pertinent medical history, drug reactions or allergies and concomitant medications was provided.  On 17-DEC-2019, the patient was vaccinated with improperly stored hepatitis a vaccine, inactivated (VAQTA) (lot # S009943, expiration date: 26-JUL-2020, strength, dose number, anatomical location and route of administration were not reported) for prophylaxis (product storage error). It was reported that the vaccine was exposed to the temperature above 47 degrees Fahrenheit/9 degree Celsius (9.3 Celsius) for 23 minutes. The previous temperature excursion were at the temperature above 47 degrees Fahrenheit/9 degree Celsius (8.7 Celsius) for 36 minutes, at the temperature above 47 degrees Fahrenheit/9 degree Celsius (8.9 Celsius) for 15 minutes and at the temperature above 47 degrees Fahrenheit/9 degree Celsius (9 Celsius) for 12 minutes. The call was because of a data logger. No adverse event was reported.  This is one of several reports received from the same reporter. combinationproductreport: Yes; brandname: VAQTA SYRINGE (DEVICE); commondevicename: Hepatitis A Vaccine, Inactivated; productcode: FMF; devicetype: SYRINGE, PISTON (FMF); manufacturername: Merck Sharp & Dohme Corp.; devicelotnumber: S009943; expirationdate: 26-JUL-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-009507513-1910USA012749:
Sex: U
Vaccine: VARZOS
Symptoms: Herpes zoster
Clinical narrative: Shingles; Information has been received from a lawyer regarding a case in litigation concerning a patient of unknown age and gender. The patient's medical history, concurrent conditions and concomitant medications were not provided. In 2018, plaintiff was inoculated with zoster vaccine live (ZOSTAVAX), (lot# and route unknown) as prescribed and/or administered by a healthcare provider for the long term prevention of shingles and/or zoster-related conditions.Subsequently to Plaintiff's zoster vaccine live (ZOSTAVAX) inoculation, plaintiff was treated at a medical office for shingles. As a direct and proximate result of Plaintiff's use of the zoster vaccine live (ZOSTAVAX), Plaintiff had 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 shingles was not provided.  The lawyer considered shingles to be related to  zoster vaccine live (ZOSTAVAX).
Age: 4.0
Sex: F
Vaccine: DTAPIPV, MMR, VARCEL
Symptoms: Dizziness, Eye movement disorder, Feeling hot, Pain in extremity, Unresponsive to stimuli
Clinical narrative: Patient complained of arm pain, hot, and light headed. Patients eyes then rolled back and she became unresponsive for 10 seconds. EMS was called, patient had normal exam and mentation status after the event.
Age: 1.25
Sex: M
Vaccine: MMR, VARCEL
Symptoms: Pyrexia, Rash, Rash vesicular
Clinical narrative: 4/30/2020 started with fever. 5/1/20  fever up to 102, rash on abdomen and face.  Tele-health appt. 5/1/20 mild spread rash on trunk mostly, not itchy. Approximately 1 dozen vesiculation lesions, Temp 100. 5/4/20 rash drier and fading.  5/7/20 rash now gone, no fever.
Age: 66.0
Sex: F
Vaccine: VARZOS
Symptoms: Syringe issue
Clinical narrative: Upon injection into LEFT deltoid, vaccine leaked out of syringe at barrel. Patient got minuscule amount of vaccine if any at all. Another Shingrix same lot # was reconstituted and injected into RIGHT deltoid without incident. Second attempt into right arm was successful.
Age: 10.0
Sex: F
Vaccine: TDAP
Symptoms: Injection site erythema, Injection site pain, Injection site swelling, Injection site warmth
Clinical narrative: Caregiver states patient has redness and swelling at injection site about 1.5 inches around. Complaining to be warm to the touch and sore. Denies any fever or itching at site.  Morning of 5/7/2020 gave loratadine as patient can't take benedryl with the other medications she is on, patient has been icing throughout the day with no spreading occurring. Provider advised  to continue monitoring , icing , and elevation. Evaluate for any spreading. Contact office if spreading  occurs any drainage, or pain worsens.
Age: 27.0
Sex: M
Vaccine: ANTH
Symptoms: Erythema, Pain, Peripheral swelling
Clinical narrative: 27 y/o M presents to clinic c/o swelling and redness on L arm on the shoulder extending to area proximal of elbow joint. SM received an Anthrax vaccine on 1/29/20 and over last 2 days swelling and redness increased. SM became concerned today when swelling increased more and became painful.SM reports taking 1000mg ibuprofen last PM around 2030 with minimal effect.  Provider assessed as allergic reaction and angioedema and treated with prednisone burst, diphenhydramine and ibuprofen.  Provider documented exemption to anthrax immunization, and documented in allergy list.
Age: 45.0
Sex: F
Vaccine: TDAP
Symptoms: Injection site erythema, Injection site pain, Injection site warmth
Clinical narrative: site reaction: erythema, warmth, and pain
Age: 70.0
Sex: F
Vaccine: PPV
Symptoms: Peripheral swelling, Pruritus, Rash
Clinical narrative: PATIENT CALLED 1 DAY AFTER HER SHOT WITH A RASH AND ITCHING, AND SWELLING IN HER ARM.  SHE WENT TO HER DR. WHO PRESCRIBED AN  ANTIBIOTIC OF KEFLEX FOR HER.
Age: 73.0
Sex: F
Vaccine: PPV
Symptoms: Injection site erythema, Injection site pain, Injection site swelling, Pain, Pyrexia
Clinical narrative: Significant swelling and soreness the night of the vaccine injection.  2 days later, very red, swollen, and pain with redness down to the elbow.  Low grade temp of 99.1 F.
Age: 73.0
Sex: F
Vaccine: PPV
Symptoms: Swelling
Clinical narrative: Significant swelling and soreness the night of the vaccine injection.  2 days later, very red, swollen, and pain with redness down to the elbow.  Low grade temp of 99.1 F.
Age: 79.0
Sex: F
Vaccine: PNC13
Symptoms: Injection site bruising, Nausea, Pyrexia, Rash
Clinical narrative: Patient had rash on arm down to elbow, a low grade fever and a bruise at the injection site.  She also reported nausea.
Age: 2.0
Sex: F
Vaccine: HEPA
Symptoms: Eye movement disorder, Presyncope, Tremor, Vomiting
Clinical narrative: pt's eyes rolled up, had shaking of body x ~10 sec and threw up, suspect vasovagal event
Age: 60.0
Sex: F
Vaccine: VARZOS
Symptoms: Headache, Injection site reaction, Pyrexia, Urticaria
Clinical narrative: patient had high fever (101.5), large welt at injection site, and headache lasting >7days
Age: 52.0
Sex: F
Vaccine: VARZOS
Symptoms: Headache, Injected limb mobility decreased, Injection site pain, Injection site swelling, Injection site warmth
Clinical narrative: Pt received Shingrix 4/22/20, the next day she called and said she was having a reaction. Injection site was swelling w/ pain, headache, body aches, reduced movement of arm with heat radating. She came in 4/23/20 4/23/20, she came in and we gave her a methylprednisolone sodium succinate 125mg intramuscular, which seemed to help with the reaction, she reaction with Both Shingrix, she got flu with first Shingrix and only reaction with the Shingrix on 1/7/20
Age: 52.0
Sex: F
Vaccine: VARZOS
Symptoms: Pain
Clinical narrative: Pt received Shingrix 4/22/20, the next day she called and said she was having a reaction. Injection site was swelling w/ pain, headache, body aches, reduced movement of arm with heat radating. She came in 4/23/20 4/23/20, she came in and we gave her a methylprednisolone sodium succinate 125mg intramuscular, which seemed to help with the reaction, she reaction with Both Shingrix, she got flu with first Shingrix and only reaction with the Shingrix on 1/7/20
Age: 0.17
Sex: M
Vaccine: DTAPHEPBIP, HIBV, PNC13, RV1
Symptoms: Chills, Cyanosis
Clinical narrative: He began to shiver intensely and his lips turned blue. This happened twice during the night. Parents wrapped him in warm blankets and had space heater running which helped. Symptoms resolved Phone calls to ED & clinic decision made to bring him in if anymore symptoms occurred
Age: 0.5
Sex: F
Vaccine: DTAPIPVHIB, HEP, PNC13, RV5
Symptoms: Vaccination site rash
Clinical narrative: Mom reports in the evening time, when pulling band aids off, she noticed a small rash, fine bumps on both legs at vaccine sites: Rash same color as pt's skin. No redness or streaks noticed. Baby not scratching sites. Mom states rash occurred also w/last set of vaccines and lasted for approx. 2 wks. No fever or other symptoms noted.
Age: 16.0
Sex: F
Vaccine: HPV9
Symptoms: Loss of consciousness, Seizure, Syncope, Vomiting
Clinical narrative: According to her publicly available interview the patient confesses to receiving the first dose of the Gardasil HPV vaccine from her gynecologist and at the time passed out (loss of consciousness/syncope), had a seizure and vomited. She also confirms that her gynecologist stated that she was having a "bad reaction to [the vaccine]" and therefore should not continue with the other 2 vaccines in the series of 3 Gardasil immunizations. No further details were provided in this interview however she is quoted on other websites as having "a TERRIBLE reaction to the HPV shot when [she] was 16 yrs old".
Age: 1.67
Sex: F
Vaccine: HEPA, UNK
Symptoms: No adverse event, Product storage error
Clinical narrative: No adverse event; The patient was administered with improperly stored VAQTA; This spontaneous report was received from a certified medical assistant (CMA) referring to a 20-month-old female patient.  No information regarding the patient's pertinent medical history, drug reactions or allergies and concomitant medications was provided.  On 25-NOV-2019, the patient was vaccinated with improperly stored hepatitis a vaccine, inactivated (VAQTA) (lot # S009943, expiration date: 26-JUL-2020, strength, dose number, anatomical location and route of administration were not reported) for prophylaxis (product storage error). It was reported that the vaccine was exposed to the temperature above 47 degrees Fahrenheit/9 degree Celsius (9.3 Celsius) for 23 minutes. The previous temperature excursion were at the temperature above 47 degrees Fahrenheit/9 degree Celsius (8.7 Celsius) for 36 minutes, at the temperature above 47 degrees Fahrenheit/9 degree Celsius (8.9 Celsius) for 15 minutes and at the temperature above 47 degrees Fahrenheit/9 degree Celsius (9 Celsius) for 12 minutes. The call was because of a data logger. No adverse event was reported.  This is one of several reports received from the same reporter. combinationproductreport: Yes; brandname: VAQTA SYRINGE (DEVICE); commondevicename: Hepatitis A Vaccine, Inactivated; productcode: FMF; devicetype: SYRINGE, PISTON (FMF); manufacturername: Merck Sharp & Dohme Corp.; manufactureraddress: ; manufacturercity: ; manufacturerstate: ; manufacturercountry: ; devicelotnumber: S009943; expirationdate: 26-JUL-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-009507513-1910USA012749:
Age: 1.0
Sex: F
Vaccine: HEPA, UNK
Symptoms: No adverse event, Product storage error
Clinical narrative: No adverse event; The patient was administered with improperly stored VAQTA; This spontaneous report was received from a certified medical assistant (CMA) referring to a 12-month-old female patient.  No information regarding the patient's pertinent medical history, drug reactions or allergies and concomitant medications was provided.  On 19-DEC-2019, the patient was vaccinated with improperly stored hepatitis a vaccine, inactivated (VAQTA) (lot # S009943, expiration date: 26-JUL-2020, strength, dose number, anatomical location and route of administration were not reported) for prophylaxis (product storage error). It was reported that the vaccine was exposed to the temperature above 47 degrees Fahrenheit/9 degree Celsius (9.3 Celsius) for 23 minutes. The previous temperature excursion were at the temperature above 47 degrees Fahrenheit/9 degree Celsius (8.7 Celsius) for 36 minutes, at the temperature above 47 degrees Fahrenheit/9 degree Celsius (8.9 Celsius) for 15 minutes and at the temperature above 47 degrees Fahrenheit/9 degree Celsius (9 Celsius) for 12 minutes. The call was because of a data logger. No adverse event was reported.  This is one of several reports received from the same reporter. combinationproductreport: Yes; brandname: VAQTA SYRINGE (DEVICE); commondevicename: Hepatitis A Vaccine, Inactivated; productcode: FMF; devicetype: SYRINGE, PISTON (FMF); manufacturername: Merck Sharp & Dohme Corp. ; devicelotnumber: S009943; expirationdate: 26-JUL-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-009507513-1910USA012749:
Age: 4.0
Sex: F
Vaccine: HEPA, UNK
Symptoms: No adverse event, Product storage error
Clinical narrative: No adverse event; The patient was administered with improperly stored VAQTA; This spontaneous report was received from a certified medical assistant (CMA) referring to a 4-year-old female patient.  No information regarding the patient's pertinent medical history, drug reactions or allergies and concomitant medications was provided.  On 12-DEC-2019, the patient was vaccinated with improperly stored hepatitis a vaccine, inactivated (VAQTA) (lot # S009943, expiration date: 26-JUL-2020, strength, dose number, anatomical location and route of administration were not reported) for prophylaxis (product storage error). It was reported that the vaccine was exposed to the temperature above 47 degrees Fahrenheit/9 degree Celsius (9.3 Celsius) for 23 minutes. The previous temperature excursion were at the temperature above 47 degrees Fahrenheit/9 degree Celsius (8.7 Celsius) for 36 minutes, at the temperature above 47 degrees Fahrenheit/9 degree Celsius (8.9 Celsius) for 15 minutes and at the temperature above 47 degrees Fahrenheit/9 degree Celsius (9 Celsius) for 12 minutes. The call was because of a data logger. No adverse event was reported.  This is one of several reports received from the same reporter. combinationproductreport: Yes; brandname: VAQTA SYRINGE (DEVICE); commondevicename: Hepatitis A Vaccine, Inactivated; productcode: FMF; devicetype: SYRINGE, PISTON (FMF); manufacturername: Merck Sharp & Dohme Corp. ; manufactureraddress: ; manufacturercity: ; manufacturerstate: ; manufacturercountry: ; devicelotnumber: S009943; expirationdate: 26-JUL-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-009507513-1910USA012749:
Age: 1.0
Sex: F
Vaccine: HEPA, UNK
Symptoms: No adverse event, Product storage error
Clinical narrative: No adverse event; The patient was administered with improperly stored VAQTA; This spontaneous report was received from a certified medical assistant (CMA) referring to a 12-month-old female patient.  No information regarding the patient's pertinent medical history, drug reactions or allergies and concomitant medications was provided.  On 18-DEC-2019, the patient was vaccinated with improperly stored hepatitis a vaccine, inactivated (VAQTA) (lot # S009943, expiration date: 26-JUL-2020, strength, dose number, anatomical location and route of administration were not reported) for prophylaxis (product storage error). It was reported that the vaccine was exposed to the temperature above 47 degrees Fahrenheit/9 degree Celsius (9.3 Celsius) for 23 minutes. The previous temperature excursion were at the temperature above 47 degrees Fahrenheit/9 degree Celsius (8.7 Celsius) for 36 minutes, at the temperature above 47 degrees Fahrenheit/9 degree Celsius (8.9 Celsius) for 15 minutes and at the temperature above 47 degrees Fahrenheit/9 degree Celsius (9 Celsius) for 12 minutes. The call was because of a data logger. No adverse event was reported.  This is one of several reports received from the same reporter. combinationproductreport: Yes; brandname: VAQTA SYRINGE (DEVICE); commondevicename: Hepatitis A Vaccine, Inactivated; productcode: FMF; devicetype: SYRINGE, PISTON (FMF); manufacturername: Merck Sharp & Dohme Corp. ; devicelotnumber: S009943; expirationdate: 26-JUL-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-009507513-1910USA012749:
Age: 1.5
Sex: F
Vaccine: HEPA, UNK
Symptoms: No adverse event, Product storage error
Clinical narrative: No adverse event; The patient was administered with improperly stored VAQTA; This spontaneous was received from a certified medical assistant (CMA) referring to an 18-month-old female patient.  No information regarding the patient's pertinent medical history, drug reactions or allergies and concomitant medications was provided.  On 20-DEC-2019, the patient was vaccinated with improperly stored hepatitis a vaccine, inactivated (VAQTA) (lot # S009943, expiration date: 26-JUL-2020, strength, dose number, anatomical location and route of administration were not reported) for prophylaxis (product storage error). It was reported that the vaccine was exposed to the temperature above 47 degrees Fahrenheit/9 degree Celsius (9.3 Celsius) for 23 minutes. The previous temperature excursion were at the temperature above 47 degrees Fahrenheit/9 degree Celsius (8.7 Celsius) for 36 minutes, at the temperature above 47 degrees Fahrenheit/9 degree Celsius (8.9 Celsius) for 15 minutes and at the temperature above 47 degrees Fahrenheit/9 degree Celsius (9 Celsius) for 12 minutes. The call was because of a data logger. No adverse event was reported.  This is one of several reports received from the same reporter. combinationproductreport: Yes; brandname: VAQTA SYRINGE (DEVICE); commondevicename: Hepatitis A Vaccine, Inactivated; productcode: FMF; devicetype: SYRINGE, PISTON (FMF); manufacturername: Merck Sharp & Dohme Corp. ; devicelotnumber: S009943; expirationdate: 26-JUL-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-009507513-1910USA012749:
Age: 2.0
Sex: M
Vaccine: HEPA, UNK
Symptoms: No adverse event, Product storage error
Clinical narrative: No adverse event; The patient was administered with improperly stored VAQTA; This spontaneous was received from a certified medical assistant (CMA) referring to 2-year-old male patient.  No information regarding the patient's pertinent medical history, drug reactions or allergies and concomitant medications was provided.  On 20-DEC-2019, the patient was vaccinated with improperly stored hepatitis a vaccine, inactivated (VAQTA) (lot # S009943, expiration date: 26-JUL-2020, strength, dose number, anatomical location and route of administration were not reported) for prophylaxis (product storage error). It was reported that the vaccine was exposed to the temperature above 47 degrees Fahrenheit/9 degree Celsius (9.3 Celsius) for 23 minutes. The previous temperature excursion were at the temperature above 47 degrees Fahrenheit/9 degree Celsius (8.7 Celsius) for 36 minutes, at the temperature above 47 degrees Fahrenheit/9 degree Celsius (8.9 Celsius) for 15 minutes and at the temperature above 47 degrees Fahrenheit/9 degree Celsius (9 Celsius) for 12 minutes. The call was because of a data logger. No adverse event was reported.  This is one of several reports received from the same reporter. combinationproductreport: Yes; brandname: VAQTA SYRINGE (DEVICE); commondevicename: Hepatitis A Vaccine, Inactivated; productcode: FMF; devicetype: SYRINGE, PISTON (FMF); manufacturername: Merck Sharp & Dohme Corp. ; devicelotnumber: S009943; expirationdate: 26-JUL-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-009507513-1910USA012749:
Age: 1.0
Sex: F
Vaccine: HEPA, UNK
Symptoms: No adverse event, Product storage error
Clinical narrative: No adverse event; The patient was administered with improperly stored VAQTA; This spontaneous report was received from a certified medical assistant (CMA) referring to 12-month-old female patient.  No information regarding the patient's pertinent medical history, drug reactions or allergies and concomitant medications was provided.  On 30-DEC-2019, the patient was vaccinated with improperly stored hepatitis a vaccine, inactivated (VAQTA) (lot # S009943, expiration date: 26-JUL-2020, strength, dose number, anatomical location and route of administration were not reported) for prophylaxis (product storage error). It was reported that the vaccine was exposed to the temperature above 47 degrees Fahrenheit/9 degree Celsius (9.3 Celsius) for 23 minutes. The previous temperature excursion were at the temperature above 47 degrees Fahrenheit/9 degree Celsius (8.7 Celsius) for 36 minutes, at the temperature above 47 degrees Fahrenheit/9 degree Celsius (8.9 Celsius) for 15 minutes and at the temperature above 47 degrees Fahrenheit/9 degree Celsius (9 Celsius) for 12 minutes. The call was because of a data logger. No adverse event was reported.  This is one of several reports received from the same reporter. combinationproductreport: Yes; brandname: VAQTA SYRINGE (DEVICE); commondevicename: Hepatitis A Vaccine, Inactivated; productcode: FMF; devicetype: SYRINGE, PISTON (FMF); manufacturername: Merck Sharp & Dohme Corp. ; manufactureraddress: ; manufacturercity: ; manufacturerstate: ; manufacturercountry:  devicelotnumber: S009943; expirationdate: 26-JUL-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-009507513-1910USA012749:
Age: 2.0
Sex: F
Vaccine: HEPA, UNK
Symptoms: No adverse event, Product storage error
Clinical narrative: No adverse event; The patient was administered with improperly stored VAQTA; This spontaneous report was received from a certified medical assistant (CMA) referring to a 2-year-old female patient.  No information regarding the patient's pertinent medical history, drug reactions or allergies and concomitant medications was provided.  On 03-DEC-2019, the patient was vaccinated with improperly stored hepatitis a vaccine, inactivated (VAQTA) (lot # S009943, expiration date: 26-JUL-2020, strength, dose number, anatomical location and route of administration were not reported) for prophylaxis (product storage error). It was reported that the vaccine was exposed to the temperature above 47 degrees Fahrenheit/9 degree Celsius (9.3 Celsius) for 23 minutes. The previous temperature excursion were at the temperature above 47 degrees Fahrenheit/9 degree Celsius (8.7 Celsius) for 36 minutes, at the temperature above 47 degrees Fahrenheit/9 degree Celsius (8.9 Celsius) for 15 minutes and at the temperature above 47 degrees Fahrenheit/9 degree Celsius (9 Celsius) for 12 minutes. The call was because of a data logger. No adverse event was reported.  This is one of several reports received from the same reporter. combinationproductreport: Yes; brandname: VAQTA SYRINGE (DEVICE); commondevicename: Hepatitis A Vaccine, Inactivated; productcode: FMF; devicetype: SYRINGE, PISTON (FMF); manufacturername: Merck Sharp & Dohme Corp. ; devicelotnumber: S009943; expirationdate: 26-JUL-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-009507513-1910USA012749:
Age: 1.0
Sex: F
Vaccine: HEPA, UNK
Symptoms: No adverse event, Product storage error
Clinical narrative: No adverse event; The patient was administered with improperly stored VAQTA; This spontaneous report was received from a certified medical assistant (CMA) referring to a 12-month-old female patient.  No information regarding the patient's pertinent medical history, drug reactions or allergies and concomitant medications was provided.  On 02-JAN-2020, the patient was vaccinated with improperly stored hepatitis a vaccine, inactivated (VAQTA) (lot # S009943, expiration date: 26-JUL-2020, strength, dose number, anatomical location and route of administration were not reported) for prophylaxis (product storage error). It was reported that the vaccine was exposed to the temperature above 47 degrees Fahrenheit/9 degree Celsius (9.3 Celsius) for 23 minutes. The previous temperature excursion were at the temperature above 47 degrees Fahrenheit/9 degree Celsius (8.7 Celsius) for 36 minutes, at the temperature above 47 degrees Fahrenheit/9 degree Celsius (8.9 Celsius) for 15 minutes and at the temperature above 47 degrees Fahrenheit/9 degree Celsius (9 Celsius) for 12 minutes. The call was because of a data logger. No adverse event was reported.  This is one of several reports received from the same reporter. combinationproductreport: Yes; brandname: VAQTA SYRINGE (DEVICE); commondevicename: Hepatitis A Vaccine, Inactivated; productcode: FMF; devicetype: SYRINGE, PISTON (FMF); manufacturername: Merck Sharp & Dohme Corp. ; devicelotnumber: S009943; expirationdate: 26-JUL-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-009507513-1910USA012749:
Age: 52.0
Sex: F
Vaccine: VARZOS
Symptoms: Aortitis, Blindness, Deafness, Ear congestion, Granulomatosis with polyangiitis
Clinical narrative: Aortitis; Vision loss; Hearing loss; Wegener's granulomatosis; Third nerve palsy; Right ear fullness; Large vessel vasculitis; viral syndrome; Information was received from a lawyer regarding a case in litigation concerning a female patient (pt) of unknown age. The pt's medical history, concurrent conditions, or concomitant medication were not provided. On an unspecified date, the pt was prescribed the zoster vaccine live (ZOSTAVAX) vaccine by a healthcare provider (HCP) for the long-term prevention of shingles and zoster-related conditions. On or about 28-JAN-2014, the pt was administered (at 52 years old) the zoster vaccine live (ZOSTAVAX) vaccine (dose, frequency, route of administration, anatomical location, lot number and expiration date were not provided) by a pharmacist. On unspecified dates, as a result of the zoster vaccine live (ZOSTAVAX) vaccine, the pt suffered the following injuries: right ear fullness, hearing loss and vision loss; and she was diagnosed with viral syndrome, aortitis, third nerve palsy, Wegener's granulomatosis and large vessel vasculitis. Outcome of the events was not provided; causal relationship was reported as related to zoster vaccine live (ZOSTAVAX).  Upon internal review, 3rd nerve paralysis, Granulomatosis with polyangiitis, Deafness, Blindness and Aortitis were determined to be medically significant events.
Age: 52.0
Sex: F
Vaccine: VARZOS
Symptoms: IIIrd nerve paralysis, Vasculitis, Viral infection
Clinical narrative: Aortitis; Vision loss; Hearing loss; Wegener's granulomatosis; Third nerve palsy; Right ear fullness; Large vessel vasculitis; viral syndrome; Information was received from a lawyer regarding a case in litigation concerning a female patient (pt) of unknown age. The pt's medical history, concurrent conditions, or concomitant medication were not provided. On an unspecified date, the pt was prescribed the zoster vaccine live (ZOSTAVAX) vaccine by a healthcare provider (HCP) for the long-term prevention of shingles and zoster-related conditions. On or about 28-JAN-2014, the pt was administered (at 52 years old) the zoster vaccine live (ZOSTAVAX) vaccine (dose, frequency, route of administration, anatomical location, lot number and expiration date were not provided) by a pharmacist. On unspecified dates, as a result of the zoster vaccine live (ZOSTAVAX) vaccine, the pt suffered the following injuries: right ear fullness, hearing loss and vision loss; and she was diagnosed with viral syndrome, aortitis, third nerve palsy, Wegener's granulomatosis and large vessel vasculitis. Outcome of the events was not provided; causal relationship was reported as related to zoster vaccine live (ZOSTAVAX).  Upon internal review, 3rd nerve paralysis, Granulomatosis with polyangiitis, Deafness, Blindness and Aortitis were determined to be medically significant events.
Sex: U
Vaccine: PPV, UNK
Symptoms: Product storage error
Clinical narrative: The patient was administered an improperly stored dose; This spontaneous report as received from a Licensed practical nurse reporting about a patient of unknown age and gender. Information regarding the patient's concurrent conditions, medical history and concomitant medications was not provided.      On 21-APR-2020, the patient was vaccinated with a dose of pneumococcal vaccine, polyvalent (23-valent) (PNEUMOVAX23) lot # S004548, expiration date: 12-AUG-2020 (dose number, route of administration and anatomical location were not reported) for prophylaxis. This dose was improperly stored at a temperature of 47.3-degree Fahrenheit for a time frame of 20 minutes and discovered due to a digital data logger. No previous temperature excursions occurred. This is one of several cases from the same source. combinationproductreport: Yes; brandname: PNEUMOVAX23 SYRINGE (DEVICE); commondevicename: Pneumococcal Vaccine, Polyvalent (23-valent); productcode: FMF; devicetype: SYRINGE, PISTON (FMF); manufacturername: Merck Sharp & Dohme Corp. ; devicelotnumber: S004548; expirationdate: 12-AUG-2020; deviceage and unit: 0 ; operatorofdevice: Nurse; malfunction: Unknown; productavailableforevaluation: No; 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:
Age: 17.0
Sex: M
Vaccine: HPV4, HPV9
Symptoms: Attention deficit hyperactivity disorder, Fatigue, Headache, Injection site inflammation, Pain in extremity
Clinical narrative: The first day the patient received the GARDASIL 9 shot, the patient experienced soreness in arm; The first day the patient received the GARDASIL 9 shot, the patient experienced inflammation at the location of the shot; The first day the patient received the GARDASIL 9 shot, the patient experienced headaches; The first day the patient received the GARDASIL 9 shot, the patient experienced fatigue; The patient was diagnosed with ADHD , wsa hypostatic when he standed up, and had distractions.; when be eats a heavy meal like pi7..7..a or lots of carbs, be throws up"; This spontaneous report was received from the patient's mother referring to her currently 20 year old male patient. The patient had no medical history, concurrent conditions, concomitant medications, and historical drugs reported.  On an unknown date, the patient was vaccinated with one shot of quadrivalent human papillomavirus (types 6,11,16,18) recomb. vaccine(GARDASIL)(strength, route, dose, frequency, anatomical location, lot # and expiration date were unknown) for prophylaxis. The patient's mother did not reported an adverse event after her son received the quadrivalent human papillomavirus (types 6,11,16,18) recomb. vaccine(GARDASIL) shot.  Subsequently, approximately in 2017 (reported as"3 years ago"), the patient was vaccinated with three shots of hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast)(GARDASIL 9) via intramuscular route (strength, dose, frequency, anatomical location, lot # and expiration date were unknown) recommended by the family physician. The patient's mother reported that starting on the first day the patient received the  hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast)(GARDASIL 9) shot (unspecifed dose number), the patient experienced soreness in his arm (pain in extremity), inflammation at the location of the shot (injection site inflammation), fatigue and headaches. Additionally, it was also reported that on unspecified dates the son was diagnosed with Attention-deficit/hyperactivity disorder (ADHD),  and was hypostatic when he standed up, and had distractions, and when he eat a heavy meal like pizza or lots of carbs, be throwup. The patient seek for medial attention but did not received any treatment for the events.  At the time of the report, the outcome of pain in extremity, vomiting, attention deficit hyperactivity disorder, fatigue, headache and injection site inflammation was reported as not resolved. The report did not mention the causality assessment between the events and hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast)(GARDASIL 9) vaccination.