chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Sex: U
Vaccine: VARCEL
Symptoms: No adverse event, Product storage error
Clinical narrative: Information has been received from a medical assistant, concerning patients of unknown age and gender. The patients' medical history, concurrent conditions, concomitant medications and drug reactions/allergies were not provided. On unknown dates, the patients were vaccinated with VARIVAX (dose, strength, frequency, route of administration, anatomical location, lot# and expiration date were not reported), for prophylaxis. The administered vaccines were improperly stored at temperature greater than 47°F but less than 77°F for 52 hours, at temperature greater than 15°F but less than 46°F for 3.5 hours and at temperature greater than 6°F but less than 14°F for 30 minutes without any previous temperature excursion. It was unknown if this information was registered in a digital data logger. No adverse effects were reported. This is one of two reports received from the same reporter.; Sender's Comments:  US-009507513-1707USA007535:
Sex: U
Vaccine: PPV
Symptoms: Adverse event
Clinical narrative: This spontaneous report has been received from a pharmacist, concerning a patient of unknown age and gender. The patient's medical history, concurrent condition and concomitant medications were not provided. On an unknown date, the patient was vaccinated with PNEUMOVAX 23 lot # M027552 and expiration date 04-FEB-2018 (dose, frequency and route of administration were not provided) for prophylaxis. At the next date of administration, the patient requested the lot number and expiration date in order to report an unspecified adverse event. The outcome of the unspecified event and causality were not reported. This is one of three reports received from the same reporter.; Sender's Comments: US-009507513-1707USA005155:
Sex: M
Vaccine: PPV
Symptoms: Erythema, Headache, Influenza like illness, Myalgia, Pyrexia
Clinical narrative: Information was received on 30-JUN-2017 from a male consumer regarding  himself (age not reported). Medical history, concurrent conditions and concomitant medications were not reported. On an unknown date, the patient was vaccinated with PNEUMOVAX 23 (lot # N003997, exp 20-OCT-2018) (dose, route, and site of administration not reported). On an unknown date, the patient experienced redness from his elbow to his shoulder, a low grade fever, muscle aches, a severe headache and felt "fluish". The outcome of the events were unknown. The relationship between the event and PNEUMOVAX 23 was not provided. Additional information is not expected as no permission was given to contact physician.
Sex: U
Vaccine: VARZOS
Symptoms: Contraindication to vaccination, No adverse event
Clinical narrative: This spontaneous report as received from a pharmacist refers to a patient of unknown age and gender. No information was provided regarding the patient's medical history or concurrent conditions. Concomitant therapies included acyclovir and sterile diluent (manufacturer unknown).  The patient was on a long term dose of acyclovir, 400 mg twice a day for "years". The pharmacist reported that the patient was vaccinated with ZOSTAVAX 19400 PFU, "1 dose" for prophylaxis (route of administration, lot number and expiration date were not reported). No adverse effect reported. No product quality complaint was filed.
Sex: U
Vaccine: RV5
Symptoms: No adverse event, Product storage error
Clinical narrative: Information has been received from a nurse concerning patients of unknown age and gender. The patients' medical history, concurrent conditions, concomitant medications and drug reactions/allergies were not provided. On unknown dates, the patients were vaccinated with ROTATEQ (lot # M007298 with expiration date 19-NOV-2017, lot # M038209 with expiration date 23-APR-2018) orally (dose, strength and frequency were not reported), for prophylaxis. The administered vaccines were improperly stored at temperature 47.1°F for 24 days without any previous temperature excursion; this information was not registered in a digital data logger. No adverse effects were reported. This is one of several reports received from the same repoter.; Sender's Comments: US-009507513-1707USA006677: US-009507513-1707USA006678: US-009507513-1707USA006507: US-009507513-1707USA006675: US-009507513-1707USA006676:
Age: 14.0
Sex: M
Vaccine: HPV9
Symptoms: Dysuria, Muscle twitching
Clinical narrative: This spontaneous report as received from a physician refers to a male patient of unknown age. On 28-JUN-2017 the patient was vaccinated with GARDASIL 9 for prophylaxis. On 29-JUN-2017, 2 days after onset of therapy the patient experienced muscle twitching and dysuria. The outcome of muscle twitching and dysuria is unknown. The reporter did not provide the causality of events with GARDASIL 9.
Age: 64.0
Sex: U
Vaccine: VARZOS
Symptoms: No adverse event, Product storage error
Clinical narrative: This spontaneous report as received from a pharmacist refers to multiple unspecified patients of unknown age. No information regarding the patients' pertinent medical history, concomitant medications, drug reactions, or allergies was provided. On unknown dates, the patients were vaccinated with improperly stored doses of ZOSTAVAX 19400 plaque-forming units (PFU)(dose and route of administration were not provided; lot # M032141, expiration date: 01-OCT-2017) reconstituted with properly stored sterile diluent (STERILE DILUENT). No adverse effects were reported. The doses of vaccine experienced the temperature excursion of 15 to 46 degrees Fahrenheit for 1 hour and 45 minutes. The doses of vaccine had experienced also previous temperature excursion of 15 to 46 degrees Fahrenheit for 15 hours. Digital data logger was involved. Additional information has been requested.
Sex: U
Vaccine: HPV9
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report was received from a medical assistant referring to an unspecified number of patients of unknown age and gender. The patients' medical history, concurrent conditions and concomitant therapies were not reported. On unknown dates, the patients were vaccinated with improperly stored doses of GARDASIL 9 (strength, dose, route, anatomical location, lot number and expiration date were not provided), for prophylaxis. It was also reported that the administered doses experienced an unknown temperature excursion during unspecified time frame on unknown dates. No previous temperature excursion and no adverse effects were reported. A data logger issue was not involved. Sender's Comments: US-009507513-1707USA007523.
Sex: U
Vaccine: MMR
Symptoms: No adverse event, Product storage error
Clinical narrative: This spontaneous report was received from a medical assistant referring to an unspecified number of patients of unknown age and gender. The patients' medical history, concurrent conditions and concomitant therapies were not reported. On unknown dates, the patients were vaccinated with improperly stored doses of M-M-R II (strength, dose, route, anatomical location, lot number and expiration date were not provided), for prophylaxis. It was also reported that the administered doses experienced an unknown temperature excursion during unspecified time frame on unknown dates. No previous temperature excursion and no adverse effects were reported. A data logger issue was not involved.; Sender's Comments: US-009507513-1707USA007394:
Sex: U
Vaccine: VARZOS
Symptoms: No adverse event, Product storage error
Clinical narrative: This spontaneous report was received from a pharmacist referring to two separated patients of unknown age and gender. Concomitant therapies included sterile diluent (DILUENT MRK). The patients' concurrent conditions and medical history were not reported. On 03-JUL-2017, the patients were vaccinated with improperly stored doses of ZOSTAVAX lot # M041086 with expiration date of 03-JAN-2018, for prophylaxis (route, anatomical location and frequency were not reported). No adverse effects were reported. It was stated that the vaccine underwent a temperature excursion of 15 to 46 degrees Fahrenheit for 40 hours 16 minutes. Previous temperature excursion was reported as 15 to 46 degrees Fahrenheit for 60 hours (worst case). The call was not because of a "data logger". No further information was provided. Additional information has been requested.; Sender's Comments: US-009507513-1707USA006623:
Sex: U
Vaccine: MMRV
Symptoms: No adverse event, Wrong drug administered
Clinical narrative: This spontaneous report was received from a registered nurse regarding a patient of unknown age and gender. The patient's medical history, current conditions and concomitant medications were not reported. On 30-JUN-2017, the patient was inadvertently vaccinated with PROQUAD lot # M038861 and expiry date: 13-MAR-2018; for prophylaxis instead of M-M-R II. The refrigerator was labeled M-M-R II, however, PROQUAD was placed in it. There were no temperature excursions. The call was due to a digital data logger. No adverse effects were reported. There was no product quality complaint involved. Additional information has been requested.
Sex: U
Vaccine: HPV9
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report as received from immunization official refers to unknown number of patients of unknown age and gender. Medical history, current conditions and concomitant medications were not reported. On an unknown date the patients were vaccinated with improperly stored GARDASIL 9 (lot # M040412, expiry date: 30-JUN-2019 and M044717, expiry date:19-JUL-2019) intramuscular unknown dose and frequency, for prophylaxis. On an unknown date the patient experienced incorrect product storage and no adverse event. No adverse events were reported. Temperature was 0 to 1 degree Centigrade with the time frame of 2 hours. Previous temperature excursion was noted. Call was because of data logger. The outcome of incorrect product storage and no adverse event is unknown. Additional information has been requested.
Sex: F
Vaccine: MENB
Symptoms: Injection site pain, Pain in extremity
Clinical narrative: This is a spontaneous report obtained from a contactable physician through a Pfizer sales representative. This physician reported similar events for two patients. This is the first of the two reports. A female patient of an unspecified age, race and ethnicity received TRUMENBA on an unknown date, at single dose, for immunization. Relevant medical history and concomitant medications were unknown. On an unspecified date, the patient experienced pain at the injection site and the arm hurt for a few days. Clinical outcome of the events was unknown at time of this report. Sender's Comments: Linked Report(s): US-PFIZER INC-2017313839 Same reporter/drug/event, different patient.
Sex: F
Vaccine: MENB
Symptoms: Injection site pain, Pain in extremity
Clinical narrative: This is a spontaneous report obtained from a contactable physician through a Pfizer sales representative. This physician reported similar events for two patients. This is the second of the two reports. A female patient of an unspecified age, race and ethnicity received TRUMENBA on an unknown date, at single dose, for immunization. Relevant medical history and concomitant medications were unknown. On an unspecified date, the patient experienced pain at the injection site and the arm hurt for a few days. Clinical outcome of the events was unknown at time of this report. Sender's Comments: Linked Report(s): US-PFIZER INC-2017313813 Same reporter/drug/event, different patient.
Sex: F
Vaccine: DTP
Symptoms: Anaphylactic reaction, Food allergy, Pyrexia, Respiratory disorder, Seizure
Clinical narrative: SERIOUSNESS CRITERIA: IMPORTANT MEDICAL EVENT. Initial unsolicited report received from consumer on 10 Jul 2017. This case involves 10 years old female patient who was vaccinated with a dose of DIPHTHERIA, TETANUS AND PERTUSSIS VACCINE (ADSORBED) (DTP) (batch number, expiry date and site of administration were not reported) intramuscularly on an unspecified date in 1998. Patient's Illness at time of vaccination and pre-existing physician diagnosed allergies, birth defects, medical conditions were reported as none. Concomitant medication was not reported. On an unspecified date, following the vaccination, the patient had high fever with a seizure after this incident, she developed respiratory issues that she never had and severe food allergies with anaphylaxis. Patient required emergency room or doctor visit. Patient did not perform any laboratory investigation. Patient was not recovered from events. Upon internal review the case was considered as serious because of important medical event: anaphylaxis and high fever with a seizure. List of documents held by sender: none. Sender's Comments: Severe food allergies with anaphylaxis, febrile seizure and nonspecific respiratory disorder are reported after vaccination with DIPHTHERIA, TETANUS AND PERTUSSIS VACCINE (ADSORBED) from unknown manufacturer. Time to onset is unknown. Cause of Anaphylaxis was reported as food allergy hence role of the vaccine can be ruled out for the event severe food allergies with anaphylaxis. More details on patient's medical history, previous vaccination history, concurrent condition, name of the vaccine administered time to onset, type of Respiratory disorder and investigation reports are needed for complete assessment of the case. Based on the available information role of vaccine cannot be drawn.
Age: 23.0
Sex: M
Vaccine: RAB
Symptoms: Hypoaesthesia, Myalgia, Pyrexia
Clinical narrative: Initial unsolicited report received from a consumer on 12-JUL-2017. This case involves a 23-year-old male patient (age also reported as 24 years) who was vaccinated with an intramuscular dose of IMOVAX in left deltoid and a dose of PASTEURIZED HUMAN RABIES IMMUNOGLOBULIN (IMOGAM) site of administration were not reported (for both the vaccines batch number, expiry date, dose, dose in series were not reported) on 11-JUL-2017. The patient had a medical history of ulcerative colitis, primary sclerosing cholangitis and asthma. It was also reported that the patient did not had any Illness at time of vaccination. Concomitant medications was not reported. On 11-JUL-2017, few hours following the vaccination, the patient experienced numbness in all extremities (also reported as less than 24 hours after receiving vaccine), fever and muscle pain. No lab test was performed. Corrective treatment was not reported. The patient had not recovered from the events. Follow up information received from a consumer on 12-JUL-2017. Lot number for Imovax updated as M13911M and lot number for Imogam was not available. List of documents held by sender: none.
Age: 27.0
Sex: F
Vaccine: VARCEL
Symptoms: Fatigue, Injection site erythema, Injection site induration, Pruritus, Rash
Clinical narrative: 27 y/o female given VARIVAX on 7/18/17 developed maculo-papular/vesicular lesions to body-more concentrated on chest with associated severe itching/fatigue also with localized erythema (approx. 2 1/2" x 1 1/2") and dime size induration to injection site.
Age: 27.0
Sex: F
Vaccine: VARCEL
Symptoms: Rash maculo-papular, Rash vesicular
Clinical narrative: 27 y/o female given VARIVAX on 7/18/17 developed maculo-papular/vesicular lesions to body-more concentrated on chest with associated severe itching/fatigue also with localized erythema (approx. 2 1/2" x 1 1/2") and dime size induration to injection site.
Age: 74.0
Sex: F
Vaccine: PNC13
Symptoms: Localised infection, Pain in extremity, Peripheral swelling, Skin discolouration, Specialist consultation
Clinical narrative: Swollen, sore arm infection, has dark mark on arm, had to go to infectious disease doctor for further treatment. Still has pain and discoloration
Age: 11.0
Sex: M
Vaccine: HPV4, MNQ
Symptoms: Injection site erythema, Injection site pruritus, Injection site swelling, Injection site warmth
Clinical narrative: 1 Day after vaccine, left shoulder and upper arm developed swelling, erythema, warmth, itching. Pt/Parent was advised on warm compress, Prednisone 15mg/5mL: take 5mL by mouth BID prescribed, and return to office if no improvement or symptoms worsen.
Age: 0.83
Sex: M
Vaccine: DTAPHEPBIP
Symptoms: Injection site erythema, Injection site swelling, Weight bearing difficulty
Clinical narrative: Fever several hours after visit to 103, right leg red/swollen and pt won't bear weight.
Age: 73.0
Sex: M
Vaccine: PPV
Symptoms: Pain in extremity, Peripheral swelling, Pruritus
Clinical narrative: The patient called the pharmacy at 9:00am 7/21/2017 stating  that the arm he received the vaccine in was very swollen, very itchy and very painful. The patient was advised to contact his physician for followup and additional instructions. The physician advised the patient to take Benadryl, ice the area, and elevate the arm.
Age: 29.0
Sex: F
Vaccine: HEP
Symptoms: Bursitis, Injection site pain, Musculoskeletal pain, Nuclear magnetic resonance imaging, Tendonitis
Clinical narrative: This case was reported by a nurse via call center representative and described the occurrence of tendonitis in a 29-year-old female patient who received ENGERIX B adult (batch number BX2X3, expiry date 13th July 2019). On 5th July 2017, the patient received the 2nd dose of ENGERIX B adult .5 ml. On 6th July 2017, 1 days after receiving ENGERIX B adult, the patient experienced tendonitis (serious criteria disability), bursitis (serious criteria disability) and injection site pain (serious criteria disability). On 9th July 2017, the patient experienced shoulder pain (serious criteria disability). On an unknown date, the outcome of the tendonitis and injection site pain were unknown and the outcome of the bursitis and shoulder pain were not recovered/not resolved. The reporter considered the tendonitis, bursitis, injection site pain and shoulder pain to be probably related to ENGERIX B adult. Additional details were provided as follows: The patient received ENGERIX B adult in the right deltoid. On 6th July 2017, the patient (who was also an employee at the reporter's office) complained of normal injection site soreness. On 9th July 2017, 4 days after vaccination, the patient went to emergency room at 2:30 am complaining of severe pain in the right shoulder. The patient returned that same day at 11:00 pm and was diagnosed with tendinitis. The patient was waiting for the results from a magnetic resonance imaging (MRI). The nurse read the clinical reports as stating bursitis and adverse effect of other vaccine and biological substances at initial encounter.
Sex: U
Vaccine: VARZOS
Symptoms: Expired product administered, No adverse event
Clinical narrative: This spontaneous report as received from a pharmacist refers to a patient of unknown age and gender. On 10-JUL-2017, the patient was inadvertently vaccinated with expired dose of ZOSTAVAX lot # M015926, expiration date: 28-JUN-2017. No adverse effects were reoprted.
Sex: F
Vaccine: VARZOS
Symptoms: Blister, Emotional distress, Herpes zoster, Nervous system disorder, Pain
Clinical narrative: Information was received from a lawyer regarding a case in litigation concerning a female patient of unknown age. No information was received regarding the patient's past medical history, concurrent conditions, or concomitant medication. The patient was inoculated with ZOSTAVAX (lot number, dosage, and route of administration not provided) on or about 21-SEP-2014 at a pharmacy, as recommended for routine adult maintenance and for the prevention of shingles. The patient used the ZOSTAVAX in the manner in which it was intended. The ZOSTAVAX did not prevent shingles as intended, but rather caused the patient to contract a persistent strain of herpes zoster. On or about 25-AUG-2016, the patient was treated at an urgent care center for a painful and blistering vesicular outbreak, which was diagnosed as herpes zoster or shingles. On or about 06-SEP-2016, the patient was treated again for ongoing and worsening conditions, which were diagnosed as post-herpetic neuralgia with nervous system involvement. The patient has been prescribed valacyclovir hydrochloride (VALTREX), codeine, and betamethasone for management of her painful and chronic condition. As a direct and proximate result of these malfunctions, the patient suffered painful injuries and damages, and required extensive medical care and treatment. As a further proximate result, the patient has suffered and will continue to suffer significant medical expenses, pain and suffering, and other damages. Additional information has been requested.
Sex: F
Vaccine: VARZOS
Symptoms: Post herpetic neuralgia, Rash, Rash vesicular
Clinical narrative: Information was received from a lawyer regarding a case in litigation concerning a female patient of unknown age. No information was received regarding the patient's past medical history, concurrent conditions, or concomitant medication. The patient was inoculated with ZOSTAVAX (lot number, dosage, and route of administration not provided) on or about 21-SEP-2014 at a pharmacy, as recommended for routine adult maintenance and for the prevention of shingles. The patient used the ZOSTAVAX in the manner in which it was intended. The ZOSTAVAX did not prevent shingles as intended, but rather caused the patient to contract a persistent strain of herpes zoster. On or about 25-AUG-2016, the patient was treated at an urgent care center for a painful and blistering vesicular outbreak, which was diagnosed as herpes zoster or shingles. On or about 06-SEP-2016, the patient was treated again for ongoing and worsening conditions, which were diagnosed as post-herpetic neuralgia with nervous system involvement. The patient has been prescribed valacyclovir hydrochloride (VALTREX), codeine, and betamethasone for management of her painful and chronic condition. As a direct and proximate result of these malfunctions, the patient suffered painful injuries and damages, and required extensive medical care and treatment. As a further proximate result, the patient has suffered and will continue to suffer significant medical expenses, pain and suffering, and other damages. Additional information has been requested.
Sex: M
Vaccine: VARZOS
Symptoms: Decreased immune responsiveness, Emotional distress, Herpes zoster, Pain, Rash
Clinical narrative: This spontaneous report was received from a lawyer regarding a case in litigation and refers to a male patient of unknown age. Medical history and concomitant medications were not provided. In 2012, the patient was inoculated with ZOSTAVAX as recommended for routine adult health maintenance and for the prevention of shingles (dose, route and lot # not provided). The vaccine did not prevent shingles as intended, but rather caused the patient to contract a persistent strain of herpes zoster. On 10-FEB-2013, he was treated by a physician at a hospital for the onset of a painful vesicular rash accompanied by weakened immune symptoms, which was diagnosed as severe herpes zoster, or shingles. As a direct and proximate result of these malfunctions, the patient suffered painful injuries and damages, and required extensive medical care and treatment.  As a further proximate result, the patient has suffered and will continue to suffer significant medical expenses, and pain and suffering, and other damages. The outcome of the events were unknown. Additional information has been requested.
Sex: M
Vaccine: VARZOS
Symptoms: Rash vesicular
Clinical narrative: This spontaneous report was received from a lawyer regarding a case in litigation and refers to a male patient of unknown age. Medical history and concomitant medications were not provided. In 2012, the patient was inoculated with ZOSTAVAX as recommended for routine adult health maintenance and for the prevention of shingles (dose, route and lot # not provided). The vaccine did not prevent shingles as intended, but rather caused the patient to contract a persistent strain of herpes zoster. On 10-FEB-2013, he was treated by a physician at a hospital for the onset of a painful vesicular rash accompanied by weakened immune symptoms, which was diagnosed as severe herpes zoster, or shingles. As a direct and proximate result of these malfunctions, the patient suffered painful injuries and damages, and required extensive medical care and treatment.  As a further proximate result, the patient has suffered and will continue to suffer significant medical expenses, and pain and suffering, and other damages. The outcome of the events were unknown. Additional information has been requested.
Sex: F
Vaccine: VARZOS
Symptoms: Blister, Decreased immune responsiveness, Discomfort, Emotional distress, Herpes zoster
Clinical narrative: Information was received on 19-JUL-2017 from a lawyer regarding a case in litigation concerning a female patient of unknown age. Medical history, concurrent conditions, or concomitant medication was not provided. On or about 01-OCT-2015 the patient was vaccinated with a dose of ZOSTAVAX (lot number, dosage, and route of administration not provided) at a pharmacy as recommended for routine adult health maintenance and for the prevention of shingles. The vaccine did not prevent shingles as intended, but rather caused the patient to contract a persistent and chronic strain of herpes zoster. On or about 05-JAN-2016 the patient was treated by a physician for blistering vesicular outbreak accompanied by weakened immune symptoms and severe discomfort and distress, which was diagnosed as herpes zoster, or shingles.  As a direct and proximate result of these malfunctions, the patient suffered painful injuries and damages and required extensive medical care and treatment. As a further proximate result the patient has suffered and will continue to suffer significant medical expenses, pain and suffering and other damages. Additional information has been requested.
Sex: F
Vaccine: VARZOS
Symptoms: Pain, Rash vesicular
Clinical narrative: Information was received on 19-JUL-2017 from a lawyer regarding a case in litigation concerning a female patient of unknown age. Medical history, concurrent conditions, or concomitant medication was not provided. On or about 01-OCT-2015 the patient was vaccinated with a dose of ZOSTAVAX (lot number, dosage, and route of administration not provided) at a pharmacy as recommended for routine adult health maintenance and for the prevention of shingles. The vaccine did not prevent shingles as intended, but rather caused the patient to contract a persistent and chronic strain of herpes zoster. On or about 05-JAN-2016 the patient was treated by a physician for blistering vesicular outbreak accompanied by weakened immune symptoms and severe discomfort and distress, which was diagnosed as herpes zoster, or shingles.  As a direct and proximate result of these malfunctions, the patient suffered painful injuries and damages and required extensive medical care and treatment. As a further proximate result the patient has suffered and will continue to suffer significant medical expenses, pain and suffering and other damages. Additional information has been requested.
Sex: F
Vaccine: VARZOS
Symptoms: Blister, Herpes zoster, Rash, Rash vesicular
Clinical narrative: Information was received from a lawyer regarding a case in litigation concerning a female patient of unknown age. No information was received regarding the patient's past medical history, concurrent conditions, or concomitant medication. The patient was inoculated with ZOSTAVAX (lot number, dosage, and route of administration not provided) on or about 02-JAN-2013 at a family medical center, as recommended for routine adult maintenance and for the prevention of shingles. The patient used the ZOSTAVAX in the manner in which it was intended. The ZOSTAVAX did not prevent shingles as intended, but rather caused the patient to contract a persistent strain of herpes zoster. On or about 14-FEB-2014, the patient was treated for a painful and blistering vesicular outbreak, which was diagnosed as herpes zoster or shingles (specific treatment not reported). As a direct and proximate result of these malfunctions, the patient suffered painful injuries and damages, and required extensive medical care and treatment. As a further proximate result, the patient has suffered and will continue to suffer significant medical expenses, pain and suffering, and other damages. Additional information has been requested.
Sex: M
Vaccine: HEPA
Symptoms: Expired product administered, No adverse event
Clinical narrative: This spontaneous report was received from a registered nurse and refers to a patient of unknown age and gender. On 11-JUL-2017, the patient was vaccinated with an expired dose of VAQTA (strength: 50/1.0 U/ml, lot # M022556 with expiry date 26-MAY-2017) intramuscularly for prophylaxis (dose and anatomical location not reported). No adverse effect was reported. No additional information was provided. Additional information has been requested.
Sex: U
Vaccine: HPV9
Symptoms: Inappropriate schedule of drug administration, No adverse event
Clinical narrative: This spontaneous report as received from a physician refers to a 15 year old patient of unknown gender. The patient concurrent condition, medical history and concomitant medication were not reported. On 07-SEP-2016, the patient was vaccinated with first dose of GARDASIL 9 for prophylaxis. On 19-JUL-2017, the patient received second dose of GARDASIL 9 for prophylaxis (Inappropriate schedule of drug administration). No adverse effects reported. No PQC reported. Additional information has been requested.
Age: 26.0
Sex: F
Vaccine: HPV4
Symptoms: Amnesia, Anxiety, Basedow's disease, Disturbance in attention, Fatigue
Clinical narrative: I was given 3 doses of GARDASIL by nurses at the Student Health Center when I was 25-26 yrs old in 2014-2015. The last dose was in June 2015. In Dec 2015 I was diagnosed with thyrotoxicosis, ending up in hospital in the ER for 3 nights at Hospital. The symptoms after vaccination were: extreme tiredness, lack of focus, lack of concentration, memory loss, high pulse, migranes, anxiety.
Age: 26.0
Sex: F
Vaccine: HPV4
Symptoms: Heart rate increased, Hyperthyroidism, Migraine, Thyroid stimulating immunoglobulin increased, Thyroxine increased
Clinical narrative: I was given 3 doses of GARDASIL by nurses at the Student Health Center when I was 25-26 yrs old in 2014-2015. The last dose was in June 2015. In Dec 2015 I was diagnosed with thyrotoxicosis, ending up in hospital in the ER for 3 nights at Hospital. The symptoms after vaccination were: extreme tiredness, lack of focus, lack of concentration, memory loss, high pulse, migranes, anxiety.
Age: 26.0
Sex: F
Vaccine: HPV4
Symptoms: Tri-iodothyronine decreased
Clinical narrative: I was given 3 doses of GARDASIL by nurses at the Student Health Center when I was 25-26 yrs old in 2014-2015. The last dose was in June 2015. In Dec 2015 I was diagnosed with thyrotoxicosis, ending up in hospital in the ER for 3 nights at Hospital. The symptoms after vaccination were: extreme tiredness, lack of focus, lack of concentration, memory loss, high pulse, migranes, anxiety.
Age: 62.0
Sex: M
Vaccine: HEPA
Symptoms: No adverse event
Clinical narrative: No adverse reaction.
Age: 1.75
Sex: F
Vaccine: DTAP, PNC13
Symptoms: Extra dose administered, No adverse event
Clinical narrative: This report is not related to an adverse event that was noted. The child received a additional dose of PCV13 vaccine that was not needed per vaccination records. No reports of any issues r/t additional dose.
Age: 13.0
Sex: M
Vaccine: HPV9
Symptoms: Condition aggravated, Dysphemia
Clinical narrative: Mother feels that the patient's stuttering worsened after second HPV injection.
Age: 4.0
Sex: M
Vaccine: MMRV
Symptoms: Blister, Rash vesicular
Clinical narrative: Mom called this RN (the immunization RN in clinic today) at approx. 08:30 stating: "my son had some vaccines last week Friday and now he has tiny blister like areas on his hands, neck, back, stomach and some on his arms now". Mom stated "it looks like he has chickenpox"; mom asked "is he contagious now?"
Age: 18.0
Sex: F
Vaccine: HEPA, MENB, MNQ, HEPA, MENB, MNQ
Symptoms: Injection site pain, Injection site reaction, Rash erythematous, Urticaria
Clinical narrative: Generalized hives more on chest, neck and arms after shots; more pronounced erythematous rash, tender to touch, minimally raised approx 10 x 6 cm at site of TRUMENBA 2.5 hrs after the shot.
Age: 18.0
Sex: F
Vaccine: HEPA, MENB, MNQ, HEPA, MENB, MNQ
Symptoms: Blood test, Urticaria
Clinical narrative: Generalized hives more on chest, neck and arms after shots; more pronounced erythematous rash, tender to touch, minimally raised approx 10 x 6 cm at site of TRUMENBA 2.5 hrs after the shot.
Age: 18.0
Sex: F
Vaccine: HEPA, MENB, MNQ, HEPA, MENB, MNQ
Symptoms: Injection site pain, Injection site reaction, Rash erythematous, Urticaria
Clinical narrative: This is a spontaneous report from a contactable nurse via Pfizer sales representative. A 18-year-old female patient of an unspecified ethnicity received TRUMENBA, via an unspecified route of administration on an unspecified date at single dose for immunization. On the same day the patient received also HEPATITIS A and PPD DISPOSABLE, both via an unspecified route of administration at an unspecified dose for immunisation. Meningococcal group b rlp2086 was administered in different anatomical site than other vaccines. Medical history included hives. The patient's concomitant medications were not reported. The patient experienced hives to chest and arm on an unspecified date. The patient experienced the event 2 1/2 hours after vaccines given. The patient underwent lab tests and procedures which included blood test for routine labs. The outcome of the event was unknown.
Age: 18.0
Sex: F
Vaccine: HEPA, MENB, MNQ, HEPA, MENB, MNQ
Symptoms: Blood test, Urticaria
Clinical narrative: This is a spontaneous report from a contactable nurse via Pfizer sales representative. A 18-year-old female patient of an unspecified ethnicity received TRUMENBA, via an unspecified route of administration on an unspecified date at single dose for immunization. On the same day the patient received also HEPATITIS A and PPD DISPOSABLE, both via an unspecified route of administration at an unspecified dose for immunisation. Meningococcal group b rlp2086 was administered in different anatomical site than other vaccines. Medical history included hives. The patient's concomitant medications were not reported. The patient experienced hives to chest and arm on an unspecified date. The patient experienced the event 2 1/2 hours after vaccines given. The patient underwent lab tests and procedures which included blood test for routine labs. The outcome of the event was unknown.
Age: 34.0
Sex: F
Vaccine: HEP, MMR, VARCEL
Symptoms: Injection site swelling
Clinical narrative: Approximately 12 hours after receiving vaccination pt reported a raised area of injection site spreading to about 2 inches with no discoloration. Size of area had decreased since then.
Age: 12.0
Sex: M
Vaccine: HPV9
Symptoms: Erythema, Generalised erythema, Pruritus, Pyrexia
Clinical narrative: PT's father reports that the day of GARDASIL, pt had subjectively high fever, generalized erythema on forearms and flat, splotchy facial erythema with itch. No op Sx's nor SOB. Resolve by next day. Father contributed above to part of the acute gastroenteritis (AGE) that pt and family were recovering from. Given that we cannot know for certain if constellation of symptoms are from the AGE or vaccine, will defer booster.
Age: 53.0
Sex: F
Vaccine: VARZOS
Symptoms: Erythema, Induration, Pain in extremity, Peripheral swelling, Pruritus
Clinical narrative: 1st 24 hours itching (red bump, small). Next 4 hours upper arm swollen, red, large hard bump, very painful. 3rd day-entire back of upper arm red, large head bump painful.
Age: 53.0
Sex: F
Vaccine: VARZOS
Symptoms: Rash erythematous
Clinical narrative: 1st 24 hours itching (red bump, small). Next 4 hours upper arm swollen, red, large hard bump, very painful. 3rd day-entire back of upper arm red, large head bump painful.
Age: 15.0
Sex: M
Vaccine: HPV9
Symptoms: Body temperature increased, Erythema, Headache, Local reaction, Pruritus
Clinical narrative: 7-20 GARDASIL 9 administered in left arm. Large local reaction (itchy, red, warm, few hives) in office. Received ZYRTEC in office. Improved in afternoon. Over night developed headache and temp 100.8. 7-21 Seen in office, clinically well, no hives, diffuse warm erythematous skin 10x13cm. No hives, non-tender, no evidence of infection.
Age: 15.0
Sex: M
Vaccine: HPV9
Symptoms: Skin warm, Urticaria
Clinical narrative: 7-20 GARDASIL 9 administered in left arm. Large local reaction (itchy, red, warm, few hives) in office. Received ZYRTEC in office. Improved in afternoon. Over night developed headache and temp 100.8. 7-21 Seen in office, clinically well, no hives, diffuse warm erythematous skin 10x13cm. No hives, non-tender, no evidence of infection.
Age: 60.0
Sex: F
Vaccine: VARZOS
Symptoms: Arthralgia, Burning sensation, Herpes zoster
Clinical narrative: Signs and symptoms since 4/27/17. Presented with an intense burning on the pelvis, strong jabs, and severe pain in the right waist all the way to the sciatic nerve. There are no signs of external blisters. Doctor specifies internal shingles. Treatment:  ZOVIRAX 800, NEURONTIN 300 and 100 mg, Amitriptyline 50, BACLOFEN and vitamin B12 1000mg IM.
Sex: M
Vaccine: HEPAB
Symptoms: Hepatitis A, Vaccination failure
Clinical narrative: This case was reported by a nurse via sales rep and described the occurrence of vaccination failure in a male patient who received TWINRIX. On an unknown date, the patient received TWINRIX. On an unknown date,  unknown  after receiving TWINRIX, the patient experienced vaccination failure (serious criteria GSK medically significant) and hepatitis A. On an unknown date, the outcome of the vaccination failure and hepatitis A were unknown. It was unknown if the reporter considered the vaccination failure and hepatitis A to be related to TWINRIX. Additional details were reported as follows: The age at vaccination was not reported. In 2008, the patient received a series of TWINRIX  and developed hepatitis A. This case had been considered as a suspected vaccination failure case since the completion of vaccination schedule, lab test confirmation and time to event onset  for hepatitis A were unknown at the time of reporting. The reporter had no patient and vaccine information.
Age: 27.0
Sex: F
Vaccine: HEP
Symptoms: Cough, Ear pain, Fatigue, Headache, Impaired work ability
Clinical narrative: Developed sore throat approximately 6 hours after receiving injection and throughout next few days developed body aches and headache. Approximately 4-5 days later, reports fever, ear ache, coughing, runny nose, headache, body ache, and fatique. Reports unable to work during this time.  Did not take temperature with thermometer.  Did not seek medical testing or care.  Reports symptoms resolved after 2 weeks and has returned to work.
Age: 27.0
Sex: F
Vaccine: HEP
Symptoms: Oropharyngeal pain, Pain, Pyrexia, Rhinorrhoea
Clinical narrative: Developed sore throat approximately 6 hours after receiving injection and throughout next few days developed body aches and headache. Approximately 4-5 days later, reports fever, ear ache, coughing, runny nose, headache, body ache, and fatique. Reports unable to work during this time.  Did not take temperature with thermometer.  Did not seek medical testing or care.  Reports symptoms resolved after 2 weeks and has returned to work.
Age: 1.25
Sex: M
Vaccine: HIBV, PNC13
Symptoms: Pruritus, Urticaria
Clinical narrative: WELTS ALL OVER BODY, ITCHING.
Age: 15.0
Sex: F
Vaccine: HPV9
Symptoms: Alopecia
Clinical narrative: This spontaneous report was received from the patient's mother, who referred to a female patient of unknown age. The patient had no allergies. No information regarding the patient's pertinent medical history and concomitant therapies was provided. On 17-JUL-2016, the patient was administered with a first dose GARDASIL 9 (dose, route of administration, lot # and expiration date was not reported) as prophylaxis. The patient completed the series of 3 doses of the vaccine (2nd and 3rd doses were administered on unknown dates). On 17-JUL-2016, also reported as on an unspecified date, the patient experienced hair loss for an unspecified reason. The outcome of the reported event was unknown. No product quality complaint was involved. The relatedness between the event and the suspect therapy was not reported. Additional information is not expected as the patient declined consent for further contact.
Sex: F
Vaccine: VARZOS
Symptoms: Blister, Herpes zoster, Rash, Rash vesicular
Clinical narrative: Information was received on 19-JUL-2017 from a lawyer regarding a case in litigation concerning a female patient of unknown age. It is being claimed that the patients,  their physicians and their pharmacists use ZOSTAVAX vaccine in the manner in which it was intended. The patient was inoculated with a dose of ZOSTAVAX vaccine on or about 07-AUG-2015 at a pharmacy, as recommended for routine adult health maintenance and for the prevention of shingles. The vaccine did not prevent shingles as intended, but rather caused the patient to contract a persistent stain of  herpes zoster. On or about 06-DEC-2016, the patient was treated by her physician for a painful and blistering vesicular outbreak which was diagnosed as herpes zoster or shingles. As a direct and proximate result of these malfunctions, the patient suffered painful injuries and damages and required  extensive medical care and treatment. As a further proximate result, the patient has suffered and will continue to suffer significant medical expenses, pain and suffering and other damages. Additional information has been requested.
Sex: F
Vaccine: VARZOS
Symptoms: Blister, Emotional distress, Herpes zoster, Pain, Post herpetic neuralgia
Clinical narrative: Information has been received on 19-JUL-2017 regarding a case in litigation regarding a female patient of unknown age. The patient's concurrent conditions, medical history and concomitant medications were not reported. The patient was inoculated with ZOSTAVAX (lot number and expiration not reported), subcutaneous as recommended for routine adult health maintenance and for the prevention of shingles at a pharmacy. The vaccine did not prevent shingles as intended, but rather caused the patient to contract a persistent strain of herpes zoster. On or about 23-MAY-2016, the patient was treated by a physician in a physician's office for a painful and blistering vesicular outbreak, which was diagnosed as herpes zoster, or shingles. On or about 23-SEP-2016, the patient was treated again by a physician in a physician's office for continuing and worsening symptoms, which was then diagnosed as post herpetic neuralgia, a chronic condition of residual nerve damage and pain secondary to shingles. As a direct and proximate result of these malfunctions, the patient suffered painful injuries and damages, and required extensive medical care and treatment. As a further proximate result, the patient has suffered and will continue to suffer significant medical expenses, pain and suffering, and other damages. Additional information has been requested.
Sex: F
Vaccine: VARZOS
Symptoms: Rash, Rash vesicular
Clinical narrative: Information has been received on 19-JUL-2017 regarding a case in litigation regarding a female patient of unknown age. The patient's concurrent conditions, medical history and concomitant medications were not reported. The patient was inoculated with ZOSTAVAX (lot number and expiration not reported), subcutaneous as recommended for routine adult health maintenance and for the prevention of shingles at a pharmacy. The vaccine did not prevent shingles as intended, but rather caused the patient to contract a persistent strain of herpes zoster. On or about 23-MAY-2016, the patient was treated by a physician in a physician's office for a painful and blistering vesicular outbreak, which was diagnosed as herpes zoster, or shingles. On or about 23-SEP-2016, the patient was treated again by a physician in a physician's office for continuing and worsening symptoms, which was then diagnosed as post herpetic neuralgia, a chronic condition of residual nerve damage and pain secondary to shingles. As a direct and proximate result of these malfunctions, the patient suffered painful injuries and damages, and required extensive medical care and treatment. As a further proximate result, the patient has suffered and will continue to suffer significant medical expenses, pain and suffering, and other damages. Additional information has been requested.
Sex: F
Vaccine: VARZOS
Symptoms: Blister, Herpes zoster, Rash, Rash vesicular
Clinical narrative: Information was received on 20-JUL-2017 from a lawyer regarding a case in litigation concerning a female patient of unknown age. It is being claimed that the patients,  their physicians and their pharmacists use ZOSTAVAX vaccine in the manner in which it was intended. The patient was inoculated with a dose of ZOSTAVAX vaccine on or about 02-FEB-2011 at a pharmacy, as recommended for routine adult health maintenance and for the prevention of shingles. The vaccine did not prevent shingles as intended, but rather caused the patient to contract a persistent stain of herpes zoster. On or about 05-JAN-2013, the patient was treated at the emergency room for a painful and blistering vesicular outbreak which was diagnosed as herpes zoster or shingles. As a direct and proximate result of these malfunctions, the patient suffered painful injuries and damages and required  extensive medical care and treatment. As a further proximate result, the patient has suffered and will continue to suffer significant medical expenses, pain and suffering and other damages. Additional information has been requested.
Sex: F
Vaccine: HPV4
Symptoms: Lymphoma
Clinical narrative: This spontaneous report was received from a physician, via a company representative, referring to a patient of unknown gender and age, but older than 26 year old. The patient's medical history, concurrent conditions, drug reactions/allergies and concomitant medications were not reported. On unknown dates, the patient was vaccinated with three doses of GARDASIL for prophylaxis (dose, route of administration, lot number and expiration date were not reported). On an unknown date, the patient was diagnosed with lymphoma and it was stated that it was unknown if the patient developed this event after receiving the GARDASIL series or prior. He was treated with stem cell therapy on unspecified dates for the lymphoma. The outcome of the event was unknown at the time of this report. Causality relationship between the event and GARDASIL was not reported. Upon internal review, the event lymphoma was determined to be medically significant.
Age: 18.0
Sex: F
Vaccine: MENB
Symptoms: Erythema, Local reaction, Lymph node pain, Lymphadenopathy, Pain
Clinical narrative: Large local reaction in shoulder with erythema, swelling, pain and itching that started on day after vaccine. On day 8 after vaccine, patient presented with enlarged axillary lymphnodes that are painful.
Age: 18.0
Sex: F
Vaccine: MENB
Symptoms: Pruritus, Swelling
Clinical narrative: Large local reaction in shoulder with erythema, swelling, pain and itching that started on day after vaccine. On day 8 after vaccine, patient presented with enlarged axillary lymphnodes that are painful.
Age: 60.0
Sex: F
Vaccine: TDAP
Symptoms: Injection site haemorrhage
Clinical narrative: Patient called pharmacy after she got vaccine saying blood was pouring from her arm.  She said she was on the way to the urgent care.
Age: 1.33
Sex: F
Vaccine: DTAPIPVHIB, HEPA, MMR, VARCEL
Symptoms: Injection site erythema, Injection site induration, Injection site swelling
Clinical narrative: Parent called Health Department re: daughter received shots previous week (7/12/17), parent stated that child's left thigh near injection sites was red, swollen, and had a hard lump the size of a quarter present. Stated child has not been fussing or had fever in days since injections. Parent stated she only noted lump today (7/21/17) when changing child. Recommended child be seen by primary care physician, parent stated she will call for an appointment.
Age: 93.0
Sex: F
Vaccine: PPV, TDAP
Symptoms: Asthenia, Bedridden, Dizziness, Fatigue, Full blood count normal
Clinical narrative: TDaP and PPSV 23 administered 1pm 12 hrs after excess fatigue, bedridden x 2wks. Mild HA myalgia, weakness, dizziness.