chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 4.0
Sex: F
Vaccine: DTAPIPV, MMR, VARCEL
Symptoms: Back pain, Blister, Herpes zoster, Rash erythematous
Clinical narrative: VARIVAX given at another office: #1 - VARIVAX 2/4/2009. #2 - VARIVAX 6/12/12. 8/20/18 seen with singles in urgent care clinic. ACUTE HPI: R upper back and R side around to the breastbone with rash, red based blistering lesions, went to outside clinic and Dx shingles, started on 500 mg valcyclovir yesterday three times a day. Outside clinic recommended here for "verification" of Dx. Started last week with aching pain in the back and blistering started on Thursday. Not described as burning. No fevers. Mom reports pt. has had vaccines for VZV but no acutal disease.
Age: 20.0
Sex: F
Vaccine: TDAP
Symptoms: Erythema, Mobility decreased, Neck pain, Skin warm
Clinical narrative: Patient received the Tdap vaccine into her (R) Deltoid, then the following day developed  moderate pain in the (R) side of her neck with warmth and redness. These symptoms lasted for five days following the injection. She did not get seen for this  by a doctor. Patient reported to Nursing staff one week following the vaccination. Patient did not develop swollen lymph nodes or fever. She had difficulty with ROM of he neck for five days.
Age: 58.0
Sex: F
Vaccine: VARZOS
Symptoms: Dizziness, Feeling cold, Injection site swelling, Pain
Clinical narrative: Pt. developed body aches, chills and dizziness. Site immunization was administered resulted in swelling no redness or streaks present. Recommended ibuprofen, TYLENOL, cool compress, increase fluid intake.
Age: 17.0
Sex: F
Vaccine: MENB
Symptoms: Gait disturbance, Injection site erythema, Injection site swelling, Injection site warmth, Pain
Clinical narrative: TRUMENBA given at 10:17 AM in left deltoid. Patient reports that in the evening she began to have body aches, redness at site of injection, fever of 100.2. Patient reported that area of redness was the size of a baseball, raised and warm to touch. Had body aches severe enough to make it difficult to walk. These symptoms occurred for a period of time of 4 days. Parent called office at 6:08 PM on 6/19/18 and spoke to triage nurse who gave instructions to give ibuprofen, tepid bath or shower, ice pack to area of redness. To ER if symptoms worsen overnight. No other calls or visits to the office until came in today 8/27/18 for a physical when patient again reported the adverse event to us. Patient is hesitant to receive any further vaccines. Today was scheduled to receive MENACTRA and Hepatitis A vaccines. We contacted Public Health and spoke to Epidemiology. They stated that patient should receive both the Hepatitis A and the MENACTRA. There should be no problems with the MENACTRA. Also, did not consider the reaction as a severe allergic reaction to TRUMENBA and would recommend that the booster dose be given at 6 months after #1 TRUMENBA. Epidemiology also recommends that patient remain in the office for observation for a period of time after receiving booster dose. Provider contacted patient but we are not certain at this time if she will agree to have the booster dose of TRUMENBA.
Age: 17.0
Sex: F
Vaccine: MENB
Symptoms: Pyrexia
Clinical narrative: TRUMENBA given at 10:17 AM in left deltoid. Patient reports that in the evening she began to have body aches, redness at site of injection, fever of 100.2. Patient reported that area of redness was the size of a baseball, raised and warm to touch. Had body aches severe enough to make it difficult to walk. These symptoms occurred for a period of time of 4 days. Parent called office at 6:08 PM on 6/19/18 and spoke to triage nurse who gave instructions to give ibuprofen, tepid bath or shower, ice pack to area of redness. To ER if symptoms worsen overnight. No other calls or visits to the office until came in today 8/27/18 for a physical when patient again reported the adverse event to us. Patient is hesitant to receive any further vaccines. Today was scheduled to receive MENACTRA and Hepatitis A vaccines. We contacted Public Health and spoke to Epidemiology. They stated that patient should receive both the Hepatitis A and the MENACTRA. There should be no problems with the MENACTRA. Also, did not consider the reaction as a severe allergic reaction to TRUMENBA and would recommend that the booster dose be given at 6 months after #1 TRUMENBA. Epidemiology also recommends that patient remain in the office for observation for a period of time after receiving booster dose. Provider contacted patient but we are not certain at this time if she will agree to have the booster dose of TRUMENBA.
Age: 5.0
Sex: M
Vaccine: DTAPIPV
Symptoms: Injection site reaction
Clinical narrative: 3 cm local reaction at site of injection. Seen by Allergist. Resolved by time seen by Allergist 8/11/18.
Age: 34.0
Sex: F
Vaccine: VARCEL, VARCEL
Symptoms: Maternal exposure before pregnancy, Pregnancy test negative, Pregnancy test urine positive
Clinical narrative: Information has been received from a physician referring to a 34 years old female patient. The patient didn't have pertinent medical history or drug reaction/allergy. Concomitant medication included vitamins iron (unspecified), minerals (unspecified), vitamins (unspecified). The patient had started a graduate program had negative titers (collected on 24-MAY-2018) for varicella and the patient had no recollection of vaccination history. On 04-JUN-2018, the patient was vaccinated with the first dose of VARIVAX (lot # N034557, expiration date 05-DEC-2019; route unknown) for prophylaxis. On the same date, the patient had a negative urine pregnancy test. On 06-JUL-2018, the patient was vaccinated with the second dose of VARIVAX (lot # N034557, expiration date 05-DEC-2019; route unknown) for prophylaxis. On 26-JUL-2018, the patient had a positive pregnancy test (urine) (vaccine exposure during pregnancy). The patient's last menstrual period (LMP) was on 23-JUN-2018, estimated delivery date (EDD) was 30-MAR-2019 with a gestation age of 4 weeks and 5 days. The pregnancy outcome was pending. The fetal outcome was unknown. There was no treatment given for event and the patient had sought medical attention.
Age: 34.0
Sex: F
Vaccine: VARCEL, VARCEL
Symptoms: Exposure during pregnancy, Pregnancy test urine positive
Clinical narrative: Information has been received from a physician referring to a 34 years old female patient. The patient didn't have pertinent medical history or drug reaction/allergy. Concomitant medication included vitamins iron (unspecified), minerals (unspecified), vitamins (unspecified). The patient had started a graduate program had negative titers (collected on 24-MAY-2018) for varicella and the patient had no recollection of vaccination history. On 04-JUN-2018, the patient was vaccinated with the first dose of VARIVAX (lot # N034557, expiration date 05-DEC-2019; route unknown) for prophylaxis. On the same date, the patient had a negative urine pregnancy test. On 06-JUL-2018, the patient was vaccinated with the second dose of VARIVAX (lot # N034557, expiration date 05-DEC-2019; route unknown) for prophylaxis. On 26-JUL-2018, the patient had a positive pregnancy test (urine) (vaccine exposure during pregnancy). The patient's last menstrual period (LMP) was on 23-JUN-2018, estimated delivery date (EDD) was 30-MAR-2019 with a gestation age of 4 weeks and 5 days. The pregnancy outcome was pending. The fetal outcome was unknown. There was no treatment given for event and the patient had sought medical attention.
Age: 50.0
Sex: F
Vaccine: VARZOS, VARZOS
Symptoms: Chills, Headache, Influenza like illness, Injection site pain, Myalgia
Clinical narrative: Patient reported severe side effects including a fever of 102 degrees, swollen glands, extreme soreness at the injection site and flu-like symptoms. She stated she was not well enough to go to work.
Age: 50.0
Sex: F
Vaccine: VARZOS, VARZOS
Symptoms: Pyrexia
Clinical narrative: Patient reported severe side effects including a fever of 102 degrees, swollen glands, extreme soreness at the injection site and flu-like symptoms. She stated she was not well enough to go to work.
Age: 50.0
Sex: F
Vaccine: VARZOS, VARZOS
Symptoms: Impaired work ability, Influenza like illness, Injection site pain, Lymphadenopathy, Pyrexia
Clinical narrative: Patient reported severe side effects including a fever of 102 degrees, swollen glands, extreme soreness at the injection site and flu-like symptoms. She stated she was not well enough to go to work.
Sex: U
Vaccine: MENB, MENB
Symptoms: Asthenia, Chest pain, Chills, Headache, Injection site pain
Clinical narrative: This is a spontaneous report from a contactable other HCP. A patient of unspecified age and gender received TRUMENBA, via an unspecified route of administration at single dose on an unspecified date for immunisation. The patient medical history and concomitant medications were not reported. The patient experienced chills, fever, severe headache, redness and swelling to the injection area on an unspecified date with outcome of unknown. The information on the lot number has been requested.
Sex: U
Vaccine: MENB, MENB
Symptoms: Pain, Pain in extremity, Pyrexia
Clinical narrative: This is a spontaneous report from a contactable other HCP. A patient of unspecified age and gender received TRUMENBA, via an unspecified route of administration at single dose on an unspecified date for immunisation. The patient medical history and concomitant medications were not reported. The patient experienced chills, fever, severe headache, redness and swelling to the injection area on an unspecified date with outcome of unknown. The information on the lot number has been requested.
Sex: U
Vaccine: MENB, MENB
Symptoms: Chills, Headache, Injection site erythema, Injection site swelling, Pyrexia
Clinical narrative: This is a spontaneous report from a contactable other HCP. A patient of unspecified age and gender received TRUMENBA, via an unspecified route of administration at single dose on an unspecified date for immunisation. The patient medical history and concomitant medications were not reported. The patient experienced chills, fever, severe headache, redness and swelling to the injection area on an unspecified date with outcome of unknown. The information on the lot number has been requested.
Age: 51.0
Sex: F
Vaccine: VARZOS, VARZOS
Symptoms: Asthenia, Chills, Fatigue, Hypersomnia, Pain in extremity
Clinical narrative: This case was reported by a consumer via call center representative and described the occurrence of chills in a 52-year-old female patient who received SHINGRIX for prophylaxis. On 14th August 2018 18:00, the patient received the 1st dose of SHINGRIX (intramuscular) .5 ml. On 14th August 2018, less than a day after receiving SHINGRIX, the patient experienced chills and injection site pain. In August 2018, the patient experienced erythematous rash and pruritus. On 15th August 2018, the patient experienced fatigue. The patient was treated with prednisone and cetirizine hydrochloride (Zyrtec). On 15th August 2018, the outcome of the chills and injection site pain were recovered/resolved. On 16th August 2018, the outcome of the fatigue was recovered/resolved. On an unknown date, the outcome of the erythematous rash and pruritus were recovering/resolving. It was unknown if the reporter considered the chills, erythematous rash, pruritus, fatigue and injection site pain to be related to SHINGRIX. Additional information was received as follows: The patient received SHINGRIX on the left arm. The patient stated that on the vaccination day, she experienced soreness at injection site and chills at middle of night. The next day of the vaccination, she experienced fatigue. This lasted for total of 24 hours, and she recovered. On 16th August 2018, around 11 AM, after receiving SHINGRIX, she noticed red rash associated with itching all over the stomach, on the back of the neck, inside both elbow joints, on the back, on the chest area, and on the lower abdomen. The patient visited a clinic and was prescribed Prednisone for 5 days, along with Zyrtec for 10 days at night. The itching was resolved, there was some redness and rash present, till the time of reporting. The patient gave permission to contact her health care provider. No further details provided.
Age: 51.0
Sex: F
Vaccine: VARZOS, VARZOS
Symptoms: Rash, Rash macular, Rash pruritic, Urticaria
Clinical narrative: This case was reported by a consumer via call center representative and described the occurrence of chills in a 52-year-old female patient who received SHINGRIX for prophylaxis. On 14th August 2018 18:00, the patient received the 1st dose of SHINGRIX (intramuscular) .5 ml. On 14th August 2018, less than a day after receiving SHINGRIX, the patient experienced chills and injection site pain. In August 2018, the patient experienced erythematous rash and pruritus. On 15th August 2018, the patient experienced fatigue. The patient was treated with prednisone and cetirizine hydrochloride (Zyrtec). On 15th August 2018, the outcome of the chills and injection site pain were recovered/resolved. On 16th August 2018, the outcome of the fatigue was recovered/resolved. On an unknown date, the outcome of the erythematous rash and pruritus were recovering/resolving. It was unknown if the reporter considered the chills, erythematous rash, pruritus, fatigue and injection site pain to be related to SHINGRIX. Additional information was received as follows: The patient received SHINGRIX on the left arm. The patient stated that on the vaccination day, she experienced soreness at injection site and chills at middle of night. The next day of the vaccination, she experienced fatigue. This lasted for total of 24 hours, and she recovered. On 16th August 2018, around 11 AM, after receiving SHINGRIX, she noticed red rash associated with itching all over the stomach, on the back of the neck, inside both elbow joints, on the back, on the chest area, and on the lower abdomen. The patient visited a clinic and was prescribed Prednisone for 5 days, along with Zyrtec for 10 days at night. The itching was resolved, there was some redness and rash present, till the time of reporting. The patient gave permission to contact her health care provider. No further details provided.
Age: 51.0
Sex: F
Vaccine: VARZOS, VARZOS
Symptoms: Chills, Fatigue, Injection site pain, Pruritus, Rash erythematous
Clinical narrative: This case was reported by a consumer via call center representative and described the occurrence of chills in a 52-year-old female patient who received SHINGRIX for prophylaxis. On 14th August 2018 18:00, the patient received the 1st dose of SHINGRIX (intramuscular) .5 ml. On 14th August 2018, less than a day after receiving SHINGRIX, the patient experienced chills and injection site pain. In August 2018, the patient experienced erythematous rash and pruritus. On 15th August 2018, the patient experienced fatigue. The patient was treated with prednisone and cetirizine hydrochloride (Zyrtec). On 15th August 2018, the outcome of the chills and injection site pain were recovered/resolved. On 16th August 2018, the outcome of the fatigue was recovered/resolved. On an unknown date, the outcome of the erythematous rash and pruritus were recovering/resolving. It was unknown if the reporter considered the chills, erythematous rash, pruritus, fatigue and injection site pain to be related to SHINGRIX. Additional information was received as follows: The patient received SHINGRIX on the left arm. The patient stated that on the vaccination day, she experienced soreness at injection site and chills at middle of night. The next day of the vaccination, she experienced fatigue. This lasted for total of 24 hours, and she recovered. On 16th August 2018, around 11 AM, after receiving SHINGRIX, she noticed red rash associated with itching all over the stomach, on the back of the neck, inside both elbow joints, on the back, on the chest area, and on the lower abdomen. The patient visited a clinic and was prescribed Prednisone for 5 days, along with Zyrtec for 10 days at night. The itching was resolved, there was some redness and rash present, till the time of reporting. The patient gave permission to contact her health care provider. No further details provided.
Age: 62.0
Sex: F
Vaccine: VARZOS, VARZOS
Symptoms: Blood pressure abnormal, Computerised tomogram normal, Dizziness, Echocardiogram, Electrocardiogram
Clinical narrative: This case was reported by a pharmacist via other and described the occurrence of increased blood pressure in a 62-year-old female patient who received SHINGRIX (batch number 7FY22, expiry date 25th April 2020) and (batch number H59LK, expiry date 25th April 2020) for prophylaxis. On 10th May 2018, the patient received SHINGRIX (intramuscular) .5 ml. On an unknown date, the dose was an unknown dose. In June 2018, 28 days after receiving SHINGRIX, the patient experienced increased blood pressure (serious criteria hospitalization, life threatening and other: as per reporter) and abnormal vision (serious criteria hospitalization, life threatening and other: as per reporter). The patient was treated with medication unknown (Blood Pressure Medication). On 16th July 2018, the outcome of the increased blood pressure and abnormal vision were recovered/resolved. It was unknown if the reporter considered the increased blood pressure and abnormal vision to be related to SHINGRIX. Additional details were provided as follows: SHINGRIX antigen batch number 7FY22 and expiry date 25th April 2020 and adjuvant batch number H59LK and expiry date 25th April 2020. The patient had issues with extreme fluctuations in blood pressure affecting her vision four weeks after she received the vaccine. She experienced increases in blood pressure and she never had increases in blood pressure before. Week of 11th June 2018 was when she noticed symptoms- went to the doctor a week later. They even had a computerized tomogram scan because they wanted to make sure she was not having a stroke or something like that. She had a regular computerized tomogram scan and it showed nothing, a week later her blood pressure was extremely high (it was affecting her vision) and they told her to go back to the emergency room. She went back and got the computerized tomogram with dye- no abnormalities with that computerized tomogram either. At the reporting date, the patient was on blood pressure medication and it was under control. The blood pressure's been good for the last 5 weeks before the reporting date. The end date was mentioned to be approximately 16th July 2018. The event was considered to be life threatening if the blood pressure could have caused (incomplete description).
Age: 62.0
Sex: F
Vaccine: VARZOS, VARZOS
Symptoms: Head discomfort, Hypertension, Muscular weakness, Scan with contrast normal, Vision blurred
Clinical narrative: This case was reported by a pharmacist via other and described the occurrence of increased blood pressure in a 62-year-old female patient who received SHINGRIX (batch number 7FY22, expiry date 25th April 2020) and (batch number H59LK, expiry date 25th April 2020) for prophylaxis. On 10th May 2018, the patient received SHINGRIX (intramuscular) .5 ml. On an unknown date, the dose was an unknown dose. In June 2018, 28 days after receiving SHINGRIX, the patient experienced increased blood pressure (serious criteria hospitalization, life threatening and other: as per reporter) and abnormal vision (serious criteria hospitalization, life threatening and other: as per reporter). The patient was treated with medication unknown (Blood Pressure Medication). On 16th July 2018, the outcome of the increased blood pressure and abnormal vision were recovered/resolved. It was unknown if the reporter considered the increased blood pressure and abnormal vision to be related to SHINGRIX. Additional details were provided as follows: SHINGRIX antigen batch number 7FY22 and expiry date 25th April 2020 and adjuvant batch number H59LK and expiry date 25th April 2020. The patient had issues with extreme fluctuations in blood pressure affecting her vision four weeks after she received the vaccine. She experienced increases in blood pressure and she never had increases in blood pressure before. Week of 11th June 2018 was when she noticed symptoms- went to the doctor a week later. They even had a computerized tomogram scan because they wanted to make sure she was not having a stroke or something like that. She had a regular computerized tomogram scan and it showed nothing, a week later her blood pressure was extremely high (it was affecting her vision) and they told her to go back to the emergency room. She went back and got the computerized tomogram with dye- no abnormalities with that computerized tomogram either. At the reporting date, the patient was on blood pressure medication and it was under control. The blood pressure's been good for the last 5 weeks before the reporting date. The end date was mentioned to be approximately 16th July 2018. The event was considered to be life threatening if the blood pressure could have caused (incomplete description).
Age: 62.0
Sex: F
Vaccine: VARZOS, VARZOS
Symptoms: Apparent life threatening event, Blood pressure fluctuation, Blood pressure increased, Computerised tomogram normal, Hypertension
Clinical narrative: This case was reported by a pharmacist via other and described the occurrence of increased blood pressure in a 62-year-old female patient who received SHINGRIX (batch number 7FY22, expiry date 25th April 2020) and (batch number H59LK, expiry date 25th April 2020) for prophylaxis. On 10th May 2018, the patient received SHINGRIX (intramuscular) .5 ml. On an unknown date, the dose was an unknown dose. In June 2018, 28 days after receiving SHINGRIX, the patient experienced increased blood pressure (serious criteria hospitalization, life threatening and other: as per reporter) and abnormal vision (serious criteria hospitalization, life threatening and other: as per reporter). The patient was treated with medication unknown (Blood Pressure Medication). On 16th July 2018, the outcome of the increased blood pressure and abnormal vision were recovered/resolved. It was unknown if the reporter considered the increased blood pressure and abnormal vision to be related to SHINGRIX. Additional details were provided as follows: SHINGRIX antigen batch number 7FY22 and expiry date 25th April 2020 and adjuvant batch number H59LK and expiry date 25th April 2020. The patient had issues with extreme fluctuations in blood pressure affecting her vision four weeks after she received the vaccine. She experienced increases in blood pressure and she never had increases in blood pressure before. Week of 11th June 2018 was when she noticed symptoms- went to the doctor a week later. They even had a computerized tomogram scan because they wanted to make sure she was not having a stroke or something like that. She had a regular computerized tomogram scan and it showed nothing, a week later her blood pressure was extremely high (it was affecting her vision) and they told her to go back to the emergency room. She went back and got the computerized tomogram with dye- no abnormalities with that computerized tomogram either. At the reporting date, the patient was on blood pressure medication and it was under control. The blood pressure's been good for the last 5 weeks before the reporting date. The end date was mentioned to be approximately 16th July 2018. The event was considered to be life threatening if the blood pressure could have caused (incomplete description).
Age: 62.0
Sex: F
Vaccine: VARZOS, VARZOS
Symptoms: Scan with contrast normal, Visual impairment
Clinical narrative: This case was reported by a pharmacist via other and described the occurrence of increased blood pressure in a 62-year-old female patient who received SHINGRIX (batch number 7FY22, expiry date 25th April 2020) and (batch number H59LK, expiry date 25th April 2020) for prophylaxis. On 10th May 2018, the patient received SHINGRIX (intramuscular) .5 ml. On an unknown date, the dose was an unknown dose. In June 2018, 28 days after receiving SHINGRIX, the patient experienced increased blood pressure (serious criteria hospitalization, life threatening and other: as per reporter) and abnormal vision (serious criteria hospitalization, life threatening and other: as per reporter). The patient was treated with medication unknown (Blood Pressure Medication). On 16th July 2018, the outcome of the increased blood pressure and abnormal vision were recovered/resolved. It was unknown if the reporter considered the increased blood pressure and abnormal vision to be related to SHINGRIX. Additional details were provided as follows: SHINGRIX antigen batch number 7FY22 and expiry date 25th April 2020 and adjuvant batch number H59LK and expiry date 25th April 2020. The patient had issues with extreme fluctuations in blood pressure affecting her vision four weeks after she received the vaccine. She experienced increases in blood pressure and she never had increases in blood pressure before. Week of 11th June 2018 was when she noticed symptoms- went to the doctor a week later. They even had a computerized tomogram scan because they wanted to make sure she was not having a stroke or something like that. She had a regular computerized tomogram scan and it showed nothing, a week later her blood pressure was extremely high (it was affecting her vision) and they told her to go back to the emergency room. She went back and got the computerized tomogram with dye- no abnormalities with that computerized tomogram either. At the reporting date, the patient was on blood pressure medication and it was under control. The blood pressure's been good for the last 5 weeks before the reporting date. The end date was mentioned to be approximately 16th July 2018. The event was considered to be life threatening if the blood pressure could have caused (incomplete description).
Age: 73.0
Sex: M
Vaccine: FLU4, PPV, VARZOS
Symptoms: Disorientation, Lethargy
Clinical narrative: He got lethargic and disoriented after getting 3 vaccines SHINGRIX, AFLURIA, and PNEUMOVAX.
Age: 24.0
Sex: F
Vaccine: FLU3
Symptoms: Dizziness, Hyperhidrosis, Injection site erythema, Injection site pain
Clinical narrative: Dizziness, sweating for 60 min., 3.5 cm erythema at site of injection painful to touch.
Age: 40.0
Sex: F
Vaccine: FLU3
Symptoms: Eye swelling, Lip swelling
Clinical narrative: Left periorbital swelling, lower lip swelling.
Sex: U
Vaccine: MMR
Symptoms: No adverse event, Product storage error
Clinical narrative: This spontaneous report was received from a registered nurse, regarding to a patient of an unknown age. The patient's concurrent, historical conditions and concomitant medications were not provided. On 10-AUG-2018 ,the patient received an expired dose (Expired vaccine used) of M-M-R II for prophylaxis (dosage, route of administration, anatomical site of injection were not provided), lot # M035388 and expiration date on 02-AUG-2018.  The vaccine was reconstituted with sterile diluent (DILUENT MRK INJ) for reconstitute the vaccine (dosage, route of administration, lot # and expiration date were not provided). The vaccine administrated had temperature excursions, the reporter said the vaccine was exposed to 9-25 (8.8) Celsius degrees for 13 minutes and 9-25 (9.3) Celsius degrees for 15 minutes. No adverse effects reported.
Sex: U
Vaccine: MMR
Symptoms: No adverse event, Product storage error
Clinical narrative: This spontaneous report was received from a registered nurse, regarding a patient of unknown age and gender. The patient's concomitant medications included sterile diluent (lot # and expiration date were not provided). The patient's medical history, concurrent conditions and drug reactions/allergies were not reported. On an unspecified date, the patient was vaccinated with improperly stored dose of M-M-R II, lot #N031294 with expiration date 21-AUG-2019, for prophylaxis (dose number, frequency, route and anatomical location were not provided).The administered dose of the vaccine experienced a temperature excursion in the range between 47°F to 77°F (52.7°F) during 2 hours and 15 minutes. The vaccine had not had any previous temperature excursions.There were no adverse effects reported. This is one of eleven reports received from the same reporter.; Sender's Comments: US-009507513-1808USA011005: US-009507513-1808USA011006: US-009507513-1808USA011007: US-009507513-1808USA011008: US-009507513-1808USA011009: US-009507513-1808USA011010: US-009507513-1808USA011011: US-009507513-1808USA011012: US-009507513-1808USA011013: US-009507513-1808USA011014:
Sex: F
Vaccine: PPV
Symptoms: Dizziness, Nausea, Pyrexia
Clinical narrative: This spontaneous report was received from a pharmacist refers to a 56-year-old female patient. The patient's pertinent medical history and concomitant medications were not reported. The patient's concurrent conditions included allergy to penicillin and azithromycin. On 09-AUG-2018 the patient was vaccinated with PNEUMOVAX 23 lot # R002354, expiration date 17-DEC-2019 (dose not provided), intramuscularly for vaccination. On 10-AUG-2018, the patient experienced dizziness, nausea and fever. The patient did take paracetamol (TYLENOL). The patient did not seek medical attention and diagnostic laboratories were not performed. As of 16-AUG-2018, the patient was recovered from the events. The pharmacist requested a Lot check and stated it was time sensitive. The relatedness between the events and PNEUMOVAX 23 was not reported. This is one of three reports received from the same reporter.; Sender's Comments: US-009507513-1808USA007518: US-009507513-1808USA007466:
Sex: M
Vaccine: HEP, HPV4, PER, UNK
Symptoms: Cancer surgery, Dysbacteriosis, Fluorescent in situ hybridisation positive, Human papilloma virus test positive, Inflammatory bowel disease
Clinical narrative: This spontaneous report was received from a consumer regarding a male patient between 25 and 27 years old. The patient might have a possible skin reaction to amoxicillin. No other pertinent medical history were provided. There were no concomitant medications. On an unspecified date in 2008 (reported as "about 10 years ago"), the patient was vaccinated with GARDASIL intramuscular route, according to the label for prophylaxis, and it was given according to dosing schedule in the prescribing information as he received the completed series (dose, strength, lot# and expiration date were not reported). Other suspect therapies included, an unspecified pertussis vaccine (unspecified) (dose, strength, lot#, expiration date and route of administration were not reported) and an unspecified hepatitis virus vaccine (manufacturer unknown) (dose, strength, lot#, expiration date and route of administration were not reported) both also for prophylaxis. On an unknown date, the patient was diagnosed with gut dysbiosis. Also, the patient on an unknown date, had a hypo response to an unspecified pertussis vaccine and an unspecified hepatitis vaccine (manufacturer unknown) (Vaccination failure). The patient was admitted to an unspecified hospital for inflammatory bowel disease that was related to the gut dysbiosis. It could not be confirmed if the patient was admitted to the hospital more than once. In 2017, about a year ago, the patient had a "growth" forming at an unspecified location, on an unspecified date the patient had a surgery to remove the growth. The growth was a verrucus carcinoma. The verrucus carcinoma was sent to a pathology test due to some abnormal cells on an unspecified date. A Fluorescence in situ hybridization (FISH) test procedure was performed and it was confirmed that the patient was positive "HPV" (human papillomavirus) types 16 and 18. The patient had a second surgery due to the abnormal cells that were not removed during the first surgery. The patient reconstructive surgery from the first surgery was deconstructed, and then a Mohs micrographic surgery was performed. The patient sought medical attention and received treatment for the events. At the reporting time, the patient had not recovered from the events. The causal relationship between the events and GARDASIL was not reported. The causality between hepatitis virus vaccine (manufacturer unknown) and pertussis vaccine (unspecified) and the events of papilloma viral infection, verrucus carcinoma, dysbacteriosis, and inflammatory bowel disease was unknown. The causality between hepatitis virus vaccine (manufacturer unknown) and pertussis vaccine (unspecified) was reported as related for the event of vaccination failure. The reporter considered the event HPV to be life-threatening. Upon internal review, the events of verrucus carcinoma and inflammatory bowel disease were considered to be medically significant.
Sex: M
Vaccine: HEP, HPV4, PER, UNK
Symptoms: Micrographic skin surgery, Neoplasm malignant, Papilloma viral infection, Pathology test, Squamous cell carcinoma
Clinical narrative: This spontaneous report was received from a consumer regarding a male patient between 25 and 27 years old. The patient might have a possible skin reaction to amoxicillin. No other pertinent medical history were provided. There were no concomitant medications. On an unspecified date in 2008 (reported as "about 10 years ago"), the patient was vaccinated with GARDASIL intramuscular route, according to the label for prophylaxis, and it was given according to dosing schedule in the prescribing information as he received the completed series (dose, strength, lot# and expiration date were not reported). Other suspect therapies included, an unspecified pertussis vaccine (unspecified) (dose, strength, lot#, expiration date and route of administration were not reported) and an unspecified hepatitis virus vaccine (manufacturer unknown) (dose, strength, lot#, expiration date and route of administration were not reported) both also for prophylaxis. On an unknown date, the patient was diagnosed with gut dysbiosis. Also, the patient on an unknown date, had a hypo response to an unspecified pertussis vaccine and an unspecified hepatitis vaccine (manufacturer unknown) (Vaccination failure). The patient was admitted to an unspecified hospital for inflammatory bowel disease that was related to the gut dysbiosis. It could not be confirmed if the patient was admitted to the hospital more than once. In 2017, about a year ago, the patient had a "growth" forming at an unspecified location, on an unspecified date the patient had a surgery to remove the growth. The growth was a verrucus carcinoma. The verrucus carcinoma was sent to a pathology test due to some abnormal cells on an unspecified date. A Fluorescence in situ hybridization (FISH) test procedure was performed and it was confirmed that the patient was positive "HPV" (human papillomavirus) types 16 and 18. The patient had a second surgery due to the abnormal cells that were not removed during the first surgery. The patient reconstructive surgery from the first surgery was deconstructed, and then a Mohs micrographic surgery was performed. The patient sought medical attention and received treatment for the events. At the reporting time, the patient had not recovered from the events. The causal relationship between the events and GARDASIL was not reported. The causality between hepatitis virus vaccine (manufacturer unknown) and pertussis vaccine (unspecified) and the events of papilloma viral infection, verrucus carcinoma, dysbacteriosis, and inflammatory bowel disease was unknown. The causality between hepatitis virus vaccine (manufacturer unknown) and pertussis vaccine (unspecified) was reported as related for the event of vaccination failure. The reporter considered the event HPV to be life-threatening. Upon internal review, the events of verrucus carcinoma and inflammatory bowel disease were considered to be medically significant.
Sex: M
Vaccine: HEP, HPV4, PER, UNK
Symptoms: Surgery, Vaccination failure
Clinical narrative: This spontaneous report was received from a consumer regarding a male patient between 25 and 27 years old. The patient might have a possible skin reaction to amoxicillin. No other pertinent medical history were provided. There were no concomitant medications. On an unspecified date in 2008 (reported as "about 10 years ago"), the patient was vaccinated with GARDASIL intramuscular route, according to the label for prophylaxis, and it was given according to dosing schedule in the prescribing information as he received the completed series (dose, strength, lot# and expiration date were not reported). Other suspect therapies included, an unspecified pertussis vaccine (unspecified) (dose, strength, lot#, expiration date and route of administration were not reported) and an unspecified hepatitis virus vaccine (manufacturer unknown) (dose, strength, lot#, expiration date and route of administration were not reported) both also for prophylaxis. On an unknown date, the patient was diagnosed with gut dysbiosis. Also, the patient on an unknown date, had a hypo response to an unspecified pertussis vaccine and an unspecified hepatitis vaccine (manufacturer unknown) (Vaccination failure). The patient was admitted to an unspecified hospital for inflammatory bowel disease that was related to the gut dysbiosis. It could not be confirmed if the patient was admitted to the hospital more than once. In 2017, about a year ago, the patient had a "growth" forming at an unspecified location, on an unspecified date the patient had a surgery to remove the growth. The growth was a verrucus carcinoma. The verrucus carcinoma was sent to a pathology test due to some abnormal cells on an unspecified date. A Fluorescence in situ hybridization (FISH) test procedure was performed and it was confirmed that the patient was positive "HPV" (human papillomavirus) types 16 and 18. The patient had a second surgery due to the abnormal cells that were not removed during the first surgery. The patient reconstructive surgery from the first surgery was deconstructed, and then a Mohs micrographic surgery was performed. The patient sought medical attention and received treatment for the events. At the reporting time, the patient had not recovered from the events. The causal relationship between the events and GARDASIL was not reported. The causality between hepatitis virus vaccine (manufacturer unknown) and pertussis vaccine (unspecified) and the events of papilloma viral infection, verrucus carcinoma, dysbacteriosis, and inflammatory bowel disease was unknown. The causality between hepatitis virus vaccine (manufacturer unknown) and pertussis vaccine (unspecified) was reported as related for the event of vaccination failure. The reporter considered the event HPV to be life-threatening. Upon internal review, the events of verrucus carcinoma and inflammatory bowel disease were considered to be medically significant.
Sex: F
Vaccine: MMR
Symptoms: Incorrect route of product administration, No adverse event
Clinical narrative: This spontaneous report was received from a doctor of pharmacy and refers to a patient of unknown age and gender. No information was provided regarding the patient's medical history, previous drug reactions, allergies, concurrent conditions or concomitant medications. On 21-AUG-2018, the patient was vaccinated with M-M-R II (dose was not reported, lot number N025891 and expiration date 19-SEP-2019) for prophylaxis by intramuscular route instead of subcutaneous route. No adverse event was reported.
Sex: F
Vaccine: HPVX
Symptoms: Multiple sclerosis
Clinical narrative: Information was received from a family physician via a company field representative and refers to a currently 29 year old female patient. No information was provided regarding medical history, concurrent conditions, or concomitant medications. The physician reported to the field representative that there was a patient who, on an unspecified date, was vaccinated with GARDASIL or GARDASIL 9. It was unknown if the patient completed the series. On an unspecified date, the patient developed multiple sclerosis. Per the physician, the patient took Merck to court and won the case indicating Quadrivalent GARDASIL or GARDASIL 9 was the cause for multiple sclerosis. When asked if the patient sought medical attention, the answer was "yes, office visit." It is unknown if the patient received treatment. The field representative added that the physician commented on a past legal case with the patient and Merck about GARDASIL or HPV GARDASIL 9 and the report was made "in passing" and was from "a few years ago." The outcome of the multiple sclerosis was unknown. Upon internal review, multiple sclerosis was considered to be medically significant. Additional information has been requested.
Sex: F
Vaccine: VARZOS
Symptoms: Blister, Herpes zoster, Rash vesicular
Clinical narrative: Information has been 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. On an unknown date in 2014, the patient was inoculated with ZOSTAVAX (lot number, dosage and route of administration not provided) at a pharmacy, as recommended for routine adult health maintenance for the prevention of shingles. The ZOSTAVAX did not prevent shingles as intended, and the patient subsequently contracted a persistent strain of herpes zoster, also known as shingles and other complications. On or about 09-AUG-2016, the patient was treated by a physician for a blistering vesicular outbreak that was diagnosed as severe herpes zoster or shingles "for the long-term prevention of shingles," the patient "suffered painful injuries and damages, and required extensive medical care and treatment." 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 is unknown. Additional information has been requested.
Sex: F
Vaccine: VARZOS
Symptoms: Blister, Herpes zoster, Rash vesicular
Clinical narrative: Information has been 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. On or about 02-MAY-2008, the patient was inoculated with ZOSTAVAX (lot number, dosage and route of administration not provided), as recommended for routine adult health maintenance for the prevention of shingles. The ZOSTAVAX did not prevent shingles as intended, and the patient subsequently contracted a persistent strain of herpes zoster, also known as shingles and other complications. On an unknown date in 2014, the patient was treated for a blistering vesicular outbreak that was diagnosed as severe herpes zoster or shingles. The outcome of the events is unknown. As a direct and proximate result of ZOSTAVAX vaccine, and/or despite receiving ZOSTAVAX for the long-term prevention of shingles, 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. Additional information has been requested.
Sex: F
Vaccine: VARZOS
Symptoms: Blister, Herpes zoster, Rash vesicular
Clinical narrative: Information has been 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. On or about 28-SEP-2015, the patient was inoculated with ZOSTAVAX (lot number, dosage and route of administration not provided) at a pharmacy, as recommended for routine adult health maintenance for the prevention of shingles. The ZOSTAVAX did not prevent shingles as intended, and the patient subsequently contracted a persistent strain of herpes zoster, also known as shingles and other complications. On or about 22-OCT-2015, the patient was treated at a hospital for a blistering vesicular outbreak that was diagnosed as severe herpes zoster or shingles. The outcome of the events is unknown. As a direct and proximate result of ZOSTAVAX vaccine, and/or despite receiving ZOSTAVAX for the long-term prevention of shingles, 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. Additional information has been requested.
Sex: F
Vaccine: VARZOS
Symptoms: Blister, Herpes zoster, Pain, Rash vesicular
Clinical narrative: Information has been 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. On or about 25-JUN-2009, the patient was inoculated with ZOSTAVAX (lot number, dosage and route of administration not provided), as recommended for routine adult health maintenance for the prevention of shingles. The ZOSTAVAX did not prevent shingles as intended, and the patient subsequently contracted a persistent strain of herpes zoster, also known as shingles and other complications. On or about 28-SEP-2015, the patient was treated for a blistering vesicular outbreak that was diagnosed as severe shingles. The patient was prescribed valacyclovir hydrochloride (VALTREX) for management of her painful symptoms and chronic pain. On or about 15-OCT-2016, the patient was treated for a blistering vesicular outbreak that was diagnosed as severe shingles. The patient was prescribed gabapentin for management of her painful symptom and chronic pain. The outcome of the events is not recovered. As a direct and proximate result of ZOSTAVAX vaccine, and/or despite receiving ZOSTAVAX for the long-term prevention of shingles, 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. Additional information has been requested.
Sex: U
Vaccine: HEPA
Symptoms: No adverse event, Product administered to patient of inappropriate age
Clinical narrative: This spontaneous report as received from a nurse refers to a pediatric patient of unknown age and gender. The patient's medical history, concurrent conditions and concomitant medications were not reported. On 22-AUG-2018, the pediatric patient was vaccinated with an adult dose of VAQTA, 1 ml, intramuscular (Lot # and expiry date was not reported) for prophylaxis. There was no adverse effects reported. There was no product quality complaint involved.
Age: 20.0
Sex: F
Vaccine: HPV4
Symptoms: Back pain, Nerve injury
Clinical narrative: Information has been received from a consumer, referring to her 20 year old daughter. Information about medical history, concurrent condition and concomitant therapy was unknown. On an unknown date, the patient was vaccinated with GARDASIL (dose, strength, route, frequency, lot# and expiration date unknown) for prophylaxis. On an unknown date, the patient experienced nerve damage, back pain (also reported as so much pain) since she received with GARDASIL. The outcome of the events was reported as not recovered. The causality assessment was not provided by the reporter.