chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 4.0
Sex: M
Vaccine: DTAP, IPV, MMR, VARCEL
Symptoms: Vomiting
Clinical narrative: On August 30, 2017, patient was suffering of a high fever. At some time during the day, his mother, gave him TYLENOL to bring down the fever. At around 5:00 PM, mother noticed that the fever had not come down and decided to dress patient up to take him to Pediatric clinic. While dressing him, mother noticed deep bruises of black and dark red on both of patient's legs. He was immediately taken to Pediatric clinic, where Dr. informed my wife and myself that his bruises appeared to be dangerous and there was nothing they could do at the clinic. She advised us to take him to the hospital as soon as possible so he could have tests run there. My wife, daughter and I proceeded to take patient to the closest hospital. I don't remember the names of the doctors but I have documents that prove that patient was there that night; but they ran tests on patient. By that time, patient had more bruises that had spread to his feet. The doctor initially believed patient had blood cancer and ran some tests. The tests came back indicating that patient's platelet count was low. They told us that they did not have the proper treatments for patient there, so he was taken by ambulance to another Hospital. Once there, more tests were run. The tests came back indicating that patient's platelet count was even lower than it was at previous hospital. The specialists proceeded on treating him with IVIG that night. The treatment made patient very sick. His fever would spike up after every dose and he would get attacks that resulted in throwing up. He finally left the hospital on September 2nd.
Age: 11.0
Sex: F
Vaccine: MNQ, TDAP
Symptoms: Crying, Injected limb mobility decreased, Injection site cellulitis, Injection site infection, Injection site warmth
Clinical narrative: Daughter had Td Booster and meningococcal on left arm at 11 AM Wednesday August 29th. When she came home that evening, still having the BAND-AIDS on from shot site, she complained about pain and not being able to move her left arm. We did cold pack on her arm the first night and when she came home the next day from school she was crying in pain and the site was hot to touch. I'd hoped it would have gotten better but by the third day I knew it was shot site infection. Took her to her doctor's clinic out of normal hours, so emergency/walk in clinic hours. They gave her an antibiotic, Cephalexin, and said she had cellulitis.
Age: 11.0
Sex: F
Vaccine: MNQ, TDAP
Symptoms: Pain in extremity
Clinical narrative: Daughter had Td Booster and meningococcal on left arm at 11 AM Wednesday August 29th. When she came home that evening, still having the BAND-AIDS on from shot site, she complained about pain and not being able to move her left arm. We did cold pack on her arm the first night and when she came home the next day from school she was crying in pain and the site was hot to touch. I'd hoped it would have gotten better but by the third day I knew it was shot site infection. Took her to her doctor's clinic out of normal hours, so emergency/walk in clinic hours. They gave her an antibiotic, Cephalexin, and said she had cellulitis.
Age: 62.0
Sex: F
Vaccine: FLUC4, VARZOS
Symptoms: Asthenia, Decreased appetite, Headache, Injection site erythema, Injection site pain
Clinical narrative: Soreness, redness, swelling, hot at injection site. Fever 100.0°, body aches especially in hands, headache, weakness, lack of appetite.
Age: 62.0
Sex: F
Vaccine: FLUC4, VARZOS
Symptoms: Injection site swelling, Injection site warmth, Pain, Pyrexia
Clinical narrative: Soreness, redness, swelling, hot at injection site. Fever 100.0°, body aches especially in hands, headache, weakness, lack of appetite.
Age: 71.0
Sex: M
Vaccine: VARZOS
Symptoms: Muscle spasms, Myalgia
Clinical narrative: Patient says he had muscle aches and muscle cramps for a long time and says he thinks it still hasn't resolved.
Age: 55.0
Sex: F
Vaccine: FLU4, PPV
Symptoms: Erythema, Pyrexia, Skin warm
Clinical narrative: Patient presented today to pharmacy with a large, warm, red spot on the arm. The area was not raised or blistered. The skin was not broken. The patient reported symptoms of a low grade fever. The redness started two days after vaccination along with the fever. Upon reading the VIS to her, she was content that this was a fairly normal reaction to the vaccine. The patient also reported that the site improved drastically with Ibuprofen therapy and intermittent ice exposure to the site. The pharmacist on duty requested that the patient check back in with him later and the patient indicated that there had been even more improvement since this morning.
Age: 51.0
Sex: F
Vaccine: FLU4
Symptoms: Injection site pain, Injection site reaction, Injection site swelling, Injection site warmth, Insomnia
Clinical narrative: Customer reported on the day of vaccine, an egg sized swelling at the site of injection, it was painful, and she described it with a fever- meaning hot to the touch. She said it hurt to sleep on. She then said it developed into a rash around the area with red dots, not raised and all localized. It resolved in 2-3 days and now you cannot tell it was given on 9/3/18.
Age: 51.0
Sex: F
Vaccine: FLU4
Symptoms: Rash erythematous
Clinical narrative: Customer reported on the day of vaccine, an egg sized swelling at the site of injection, it was painful, and she described it with a fever- meaning hot to the touch. She said it hurt to sleep on. She then said it developed into a rash around the area with red dots, not raised and all localized. It resolved in 2-3 days and now you cannot tell it was given on 9/3/18.
Age: 11.0
Sex: M
Vaccine: HPV9, MNQ
Symptoms: Dizziness, Nausea, Pain in extremity, Skin warm
Clinical narrative: Felt warm and arm sore the evening of the vaccination. Woke up dizzy and nauseous, no vomiting.
Age: 4.0
Sex: M
Vaccine: DTAPIPV, MMR, VARCEL
Symptoms: Injection site erythema, Injection site pruritus, Injection site reaction, Urticaria
Clinical narrative: 5 x 5 cm urticarial rash around injection site started 30 minutes after injection. Was given 5 ml of BENADRYL with improvement of itching and redness. Observed x 30 minutes with no worsening of symptoms.
Age: 59.0
Sex: M
Vaccine: VARZOS
Symptoms: Influenza like illness, Local reaction, Pyrexia
Clinical narrative: Per information provided to me by the immunizer and pharmacist on duty - patient had localized reaction, fever and flu-like symptoms on the evening of the day the shot was given. Per immunizer, when she followed up with the patient on 08/30 he had recovered and no longer had the symptoms.
Age: 70.0
Sex: F
Vaccine: FLU3
Symptoms: Injection site erythema, Injection site pain, Injection site warmth
Clinical narrative: Warm, erythematous and tender area 2-3 inches below injection site. Patient states after 2 days it has started to get better.
Age: 62.0
Sex: F
Vaccine: FLU4
Symptoms: Injection site erythema, Injection site pain, Injection site warmth
Clinical narrative: Warm, erythematous, tender area 2-3 inches below injection site that is progressively spreading.
Age: 82.0
Sex: F
Vaccine: PPV
Symptoms: Injection site erythema, Injection site swelling, Injection site warmth
Clinical narrative: Patient stated that within 24 hours the right arm became swollen, hot to touch and red in appearance from underside of arm to the elbow. She was treated at a walk-in clinic at 48 hours, given a prescription for an antibiotic to take for 10 days and advised to ice the arm.
Age: 55.0
Sex: F
Vaccine: VARZOS
Symptoms: Fatigue, Gastrointestinal pain, Headache, Pyrexia
Clinical narrative: Fever of 99.6 degrees for 6 hours, followed by GI pain for 2 hours. Extreme fatigue for 24 hours, headache the 2nd day for 2 hours.
Age: 54.0
Sex: F
Vaccine: VARZOS
Symptoms: Abdominal pain upper, Chest discomfort, Cold sweat, Confusional state, Decreased appetite
Clinical narrative: Sore left arm day #1, discomfort into neck and chest wall on same side, used ice pack to reduce inflammation. That evening took DUEXIS (with food) antiinflammatory before bed. Woke with nausea, diarrhea, clamminess, felt orthostatic and had to lay on bathroom floor for 20 minutes. Day #2, laid on couch all day, decreased appetite, sore stomach, neck and head. Lethargy, mild confusion. History of Reyes syndrome at age 5 when had chicken pox hospitalized at hospital in coma for 5 days.
Age: 54.0
Sex: F
Vaccine: VARZOS
Symptoms: Diarrhoea, Headache, Inflammation, Lethargy, Musculoskeletal discomfort
Clinical narrative: Sore left arm day #1, discomfort into neck and chest wall on same side, used ice pack to reduce inflammation. That evening took DUEXIS (with food) antiinflammatory before bed. Woke with nausea, diarrhea, clamminess, felt orthostatic and had to lay on bathroom floor for 20 minutes. Day #2, laid on couch all day, decreased appetite, sore stomach, neck and head. Lethargy, mild confusion. History of Reyes syndrome at age 5 when had chicken pox hospitalized at hospital in coma for 5 days.
Age: 54.0
Sex: F
Vaccine: VARZOS
Symptoms: Nausea, Neck pain, Pain in extremity, Syncope
Clinical narrative: Sore left arm day #1, discomfort into neck and chest wall on same side, used ice pack to reduce inflammation. That evening took DUEXIS (with food) antiinflammatory before bed. Woke with nausea, diarrhea, clamminess, felt orthostatic and had to lay on bathroom floor for 20 minutes. Day #2, laid on couch all day, decreased appetite, sore stomach, neck and head. Lethargy, mild confusion. History of Reyes syndrome at age 5 when had chicken pox hospitalized at hospital in coma for 5 days.
Age: 79.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site erythema, Injection site pruritus, Injection site swelling
Clinical narrative: Swollen, red, itchy at injection site.
Age: 70.0
Sex: F
Vaccine: VARZOS
Symptoms: Myalgia, Pyrexia, Rash, Skin warm
Clinical narrative: Patient reported the adverse events that she experienced just after the immunization with SHINGRIX were rash, warm area, low grade fever and muscle ache. She mentioned that she was in the bed for couple of days, ADEs resolved after 3 days.
Age: 55.0
Sex: F
Vaccine: VARZOS
Symptoms: Fatigue, Headache, Injection site erythema, Injection site pain, Injection site pruritus
Clinical narrative: Felt achy with a headache when I woke up Saturday morning after having the shot the day before. The injection site is extremely sore and red with raised bump. Took 2 ALEVE and achiness seemed to ease... Pain at injection site continues as well as red and raised bump. Sunday was better but still had headache and felt tired. Injection site still red and very sore with raised bump. Monday feeling tired...Injection site still very sore and red with raised bump. There is beginning to be itching around the bump...too painful to really scratch.
Age: 55.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site rash, Injection site swelling, Pain
Clinical narrative: Felt achy with a headache when I woke up Saturday morning after having the shot the day before. The injection site is extremely sore and red with raised bump. Took 2 ALEVE and achiness seemed to ease... Pain at injection site continues as well as red and raised bump. Sunday was better but still had headache and felt tired. Injection site still red and very sore with raised bump. Monday feeling tired...Injection site still very sore and red with raised bump. There is beginning to be itching around the bump...too painful to really scratch.
Age: 63.0
Sex: M
Vaccine: VARZOS
Symptoms: Lethargy, Oral mucosal blistering
Clinical narrative: Pt described appearance of blisters in his mouth approx. 1 week after vaccine and feeling lethargic.
Sex: F
Vaccine: VARZOS, VARZOS
Symptoms: Arthralgia, Chills, Diarrhoea, Fatigue, Headache
Clinical narrative: This case was reported by a consumer via call center representative and described the occurrence of sickness in a adult female patient who received SHINGRIX for prophylaxis. On an unknown date, the patient received the 1st dose of SHINGRIX. On an unknown date, less than a year after receiving SHINGRIX, the patient experienced sickness. On an unknown date, the outcome of the sickness was recovered/resolved. It was unknown if the reporter considered the sickness to be related to SHINGRIX. Additional details were provided as follows: The age at vaccination was not reported. The patient had the SHINGRIX shot and had terrible reaction. The patient stated that she was sick for 5 days. She was calling to see what the efficacy of having only one shot was because she was not sure if she was going to get the second one. No further information was gathered as the patient wanted to get off the phone or ended the call and stated that she had already reported these events to the Centers for Disease Control and Prevention (CDC). The patient refused to give her street address.
Sex: F
Vaccine: VARZOS, VARZOS
Symptoms: Injection site pain, Myalgia, Nausea, Rash
Clinical narrative: This case was reported by a consumer via call center representative and described the occurrence of sickness in a adult female patient who received SHINGRIX for prophylaxis. On an unknown date, the patient received the 1st dose of SHINGRIX. On an unknown date, less than a year after receiving SHINGRIX, the patient experienced sickness. On an unknown date, the outcome of the sickness was recovered/resolved. It was unknown if the reporter considered the sickness to be related to SHINGRIX. Additional details were provided as follows: The age at vaccination was not reported. The patient had the SHINGRIX shot and had terrible reaction. The patient stated that she was sick for 5 days. She was calling to see what the efficacy of having only one shot was because she was not sure if she was going to get the second one. No further information was gathered as the patient wanted to get off the phone or ended the call and stated that she had already reported these events to the Centers for Disease Control and Prevention (CDC). The patient refused to give her street address.
Sex: F
Vaccine: VARZOS, VARZOS
Symptoms: Malaise, Vaccination complication
Clinical narrative: This case was reported by a consumer via call center representative and described the occurrence of sickness in a adult female patient who received SHINGRIX for prophylaxis. On an unknown date, the patient received the 1st dose of SHINGRIX. On an unknown date, less than a year after receiving SHINGRIX, the patient experienced sickness. On an unknown date, the outcome of the sickness was recovered/resolved. It was unknown if the reporter considered the sickness to be related to SHINGRIX. Additional details were provided as follows: The age at vaccination was not reported. The patient had the SHINGRIX shot and had terrible reaction. The patient stated that she was sick for 5 days. She was calling to see what the efficacy of having only one shot was because she was not sure if she was going to get the second one. No further information was gathered as the patient wanted to get off the phone or ended the call and stated that she had already reported these events to the Centers for Disease Control and Prevention (CDC). The patient refused to give her street address.
Age: 1.25
Sex: F
Vaccine: HEPA, HEPA
Symptoms: Expired product administered, No adverse event
Clinical narrative: This spontaneous report was received from a nurse refers to a 15 month old female patient. The patient's medical history, concurrent condition, concomitant medications and drug reactions/allergies were not reported. On 21-JUN-2018, the patient received an expired dose of VAQTA injection 25/0.5 (unspecified units) (dose and frequency were not reported) (lot # N005274 and expiry date: 03-APR-2018) intramuscularly for prophylaxis (expired product administered). No adverse effect was reported. There was no product quality complaint (PQC) reported.
Age: 83.0
Sex: F
Vaccine: VARZOS, VARZOS
Symptoms: Fatigue, Malaise
Clinical narrative: After 1st immunization, low blood pressure 88/40, fatigue. After 2nd, excruciating joint pain, myalgia, low B/P, fever, chills, fatigue. Horrible-unable to walk for 2 days. Still have stiff neck, pain, fatigue on Aug 27, 2018.
Age: 83.0
Sex: F
Vaccine: VARZOS, VARZOS
Symptoms: Arthralgia, Chills, Fatigue, Gait inability, Hypotension
Clinical narrative: After 1st immunization, low blood pressure 88/40, fatigue. After 2nd, excruciating joint pain, myalgia, low B/P, fever, chills, fatigue. Horrible-unable to walk for 2 days. Still have stiff neck, pain, fatigue on Aug 27, 2018.
Age: 83.0
Sex: F
Vaccine: VARZOS, VARZOS
Symptoms: Musculoskeletal stiffness, Myalgia, Pain
Clinical narrative: After 1st immunization, low blood pressure 88/40, fatigue. After 2nd, excruciating joint pain, myalgia, low B/P, fever, chills, fatigue. Horrible-unable to walk for 2 days. Still have stiff neck, pain, fatigue on Aug 27, 2018.
Age: 39.0
Sex: F
Vaccine: HEP, VARCEL, VARCEL
Symptoms: Exposure during pregnancy
Clinical narrative: This spontaneous prospective pregnancy report was received from a Nurse via a company representative referring to 39 year old female patient. The patient's concurrent conditions and medical history were not reported. The patient's last menstrual period was on 20-JUN-2018. It was informed that the patient believed she conceived on either 01-JUL-2018 or 03-JUL-2018. On 16-JUL-2018, while patient was pregnant, she was vaccinated with a dose of VARIVAX injection, (route and anatomical location were not reported) (lot # R006220; expiration date 29-FEB-2020) for varicella prevention. The Estimated Date of Delivery was 27-MAR-2019. On an unspecified date, the patient sought unspecified medical attention. At the reporting time the pregnancy outcome was unknown and was pending.
Age: 71.0
Sex: M
Vaccine: PPV, PPV
Symptoms: Blood culture, Blood lactic acid normal, Chest X-ray, Culture urine, Electrocardiogram
Clinical narrative: This spontaneous report was received from a nurse navigator and refers to a 71-year-old male patient. The patient did not have any pertinent medical history, drug reaction or allergies and did not take any concomitant medications. On 20-AUG-2018, the patient was vaccinated with PNEUMOVAX 23 intramuscularly (lot # reported as N01488, expiration date: 31-JAN-2019, dose was not provided) to prevent pneumonia. On 21-AUG-2018, the patient was admitted to emergency room with a diagnosis of cellulitis starting at the injection site reported as back part of the deltoid of unspecified arm which had spread down past the elbow. The patient was treated with clindamycin 150 mg and discharged to home from the emergency room on the same date. No lab diagnostics or studies were performed. The outcome of cellulitis starting at the injection site, back part of the deltoid of unspecified arm which had spread down past the elbow was unknown. The relatedness between the event and PNEUMOVAX 23 was not reported. Upon internal review, the event of cellulitis of arm was considered to be medically significant.
Age: 71.0
Sex: M
Vaccine: PPV, PPV
Symptoms: Full blood count, Injection site cellulitis, Injection site erythema, Injection site swelling, Metabolic function test
Clinical narrative: This spontaneous report was received from a nurse navigator and refers to a 71-year-old male patient. The patient did not have any pertinent medical history, drug reaction or allergies and did not take any concomitant medications. On 20-AUG-2018, the patient was vaccinated with PNEUMOVAX 23 intramuscularly (lot # reported as N01488, expiration date: 31-JAN-2019, dose was not provided) to prevent pneumonia. On 21-AUG-2018, the patient was admitted to emergency room with a diagnosis of cellulitis starting at the injection site reported as back part of the deltoid of unspecified arm which had spread down past the elbow. The patient was treated with clindamycin 150 mg and discharged to home from the emergency room on the same date. No lab diagnostics or studies were performed. The outcome of cellulitis starting at the injection site, back part of the deltoid of unspecified arm which had spread down past the elbow was unknown. The relatedness between the event and PNEUMOVAX 23 was not reported. Upon internal review, the event of cellulitis of arm was considered to be medically significant.
Age: 71.0
Sex: M
Vaccine: PPV, PPV
Symptoms: Wheezing
Clinical narrative: This spontaneous report was received from a nurse navigator and refers to a 71-year-old male patient. The patient did not have any pertinent medical history, drug reaction or allergies and did not take any concomitant medications. On 20-AUG-2018, the patient was vaccinated with PNEUMOVAX 23 intramuscularly (lot # reported as N01488, expiration date: 31-JAN-2019, dose was not provided) to prevent pneumonia. On 21-AUG-2018, the patient was admitted to emergency room with a diagnosis of cellulitis starting at the injection site reported as back part of the deltoid of unspecified arm which had spread down past the elbow. The patient was treated with clindamycin 150 mg and discharged to home from the emergency room on the same date. No lab diagnostics or studies were performed. The outcome of cellulitis starting at the injection site, back part of the deltoid of unspecified arm which had spread down past the elbow was unknown. The relatedness between the event and PNEUMOVAX 23 was not reported. Upon internal review, the event of cellulitis of arm was considered to be medically significant.
Age: 71.0
Sex: M
Vaccine: PPV, PPV
Symptoms: Cellulitis, Injection site cellulitis
Clinical narrative: This spontaneous report was received from a nurse navigator and refers to a 71-year-old male patient. The patient did not have any pertinent medical history, drug reaction or allergies and did not take any concomitant medications. On 20-AUG-2018, the patient was vaccinated with PNEUMOVAX 23 intramuscularly (lot # reported as N01488, expiration date: 31-JAN-2019, dose was not provided) to prevent pneumonia. On 21-AUG-2018, the patient was admitted to emergency room with a diagnosis of cellulitis starting at the injection site reported as back part of the deltoid of unspecified arm which had spread down past the elbow. The patient was treated with clindamycin 150 mg and discharged to home from the emergency room on the same date. No lab diagnostics or studies were performed. The outcome of cellulitis starting at the injection site, back part of the deltoid of unspecified arm which had spread down past the elbow was unknown. The relatedness between the event and PNEUMOVAX 23 was not reported. Upon internal review, the event of cellulitis of arm was considered to be medically significant.
Age: 16.0
Sex: F
Vaccine: HPV9, HPV9
Symptoms: Differential white blood cell count, Epstein-Barr virus antibody, Eye swelling, Eyelid oedema, Full blood count
Clinical narrative: This spontaneous report was received from a physician via a company representative referring to a 16 year old female patient. The patient had no medical history, concurrent conditions or concomitant medications. On 27-AUG-2018, the patient was vaccinated with GARDASIL 9 lot number N025428 and expiration date of 19-JUN-2020 for prophylaxis (dose, route of administration and anatomical location were not reported). On the same date, 2 hours after the administration of GARDASIL 9 the patient vomited and experienced facial hives, puffy eyes (eye swelling) and swollen lip. On 28-AUG-2018, the patient was seen by the physician and the conditions were worsening. Furthermore, the patient received treatment to the aforementioned events. There were no laboratory diagnostics or studies performed. It was also mentioned that the patient would have an appointment with an unspecified allergist on 04-SEP-2018. The outcome of eye swelling, lip swelling, urticaria and vomiting was reported as not resolved. Additionally, the reporter did not provided causality assessment between the events and vaccination with GARDASIL 9.
Age: 16.0
Sex: F
Vaccine: HPV9, HPV9
Symptoms: Mononucleosis heterophile test, Oropharyngeal pain, Red blood cell sedimentation rate, Swelling face, Tonsillar erythema
Clinical narrative: This spontaneous report was received from a physician via a company representative referring to a 16 year old female patient. The patient had no medical history, concurrent conditions or concomitant medications. On 27-AUG-2018, the patient was vaccinated with GARDASIL 9 lot number N025428 and expiration date of 19-JUN-2020 for prophylaxis (dose, route of administration and anatomical location were not reported). On the same date, 2 hours after the administration of GARDASIL 9 the patient vomited and experienced facial hives, puffy eyes (eye swelling) and swollen lip. On 28-AUG-2018, the patient was seen by the physician and the conditions were worsening. Furthermore, the patient received treatment to the aforementioned events. There were no laboratory diagnostics or studies performed. It was also mentioned that the patient would have an appointment with an unspecified allergist on 04-SEP-2018. The outcome of eye swelling, lip swelling, urticaria and vomiting was reported as not resolved. Additionally, the reporter did not provided causality assessment between the events and vaccination with GARDASIL 9.
Age: 16.0
Sex: F
Vaccine: HPV9, HPV9
Symptoms: Tonsillar exudate, Urticaria, Vomiting
Clinical narrative: This spontaneous report was received from a physician via a company representative referring to a 16 year old female patient. The patient had no medical history, concurrent conditions or concomitant medications. On 27-AUG-2018, the patient was vaccinated with GARDASIL 9 lot number N025428 and expiration date of 19-JUN-2020 for prophylaxis (dose, route of administration and anatomical location were not reported). On the same date, 2 hours after the administration of GARDASIL 9 the patient vomited and experienced facial hives, puffy eyes (eye swelling) and swollen lip. On 28-AUG-2018, the patient was seen by the physician and the conditions were worsening. Furthermore, the patient received treatment to the aforementioned events. There were no laboratory diagnostics or studies performed. It was also mentioned that the patient would have an appointment with an unspecified allergist on 04-SEP-2018. The outcome of eye swelling, lip swelling, urticaria and vomiting was reported as not resolved. Additionally, the reporter did not provided causality assessment between the events and vaccination with GARDASIL 9.
Age: 16.0
Sex: F
Vaccine: HPV9, HPV9
Symptoms: Eyelid oedema, Lip swelling, Urticaria, Vomiting
Clinical narrative: This spontaneous report was received from a physician via a company representative referring to a 16 year old female patient. The patient had no medical history, concurrent conditions or concomitant medications. On 27-AUG-2018, the patient was vaccinated with GARDASIL 9 lot number N025428 and expiration date of 19-JUN-2020 for prophylaxis (dose, route of administration and anatomical location were not reported). On the same date, 2 hours after the administration of GARDASIL 9 the patient vomited and experienced facial hives, puffy eyes (eye swelling) and swollen lip. On 28-AUG-2018, the patient was seen by the physician and the conditions were worsening. Furthermore, the patient received treatment to the aforementioned events. There were no laboratory diagnostics or studies performed. It was also mentioned that the patient would have an appointment with an unspecified allergist on 04-SEP-2018. The outcome of eye swelling, lip swelling, urticaria and vomiting was reported as not resolved. Additionally, the reporter did not provided causality assessment between the events and vaccination with GARDASIL 9.
Sex: F
Vaccine: HPV9
Symptoms: Abdominal pain upper, Autoimmune disorder, Burning sensation, Feeling abnormal, Gait disturbance
Clinical narrative: This non-valid spontaneous report was received from a physician regarding a patient of unknown age and gender. The patient's pertinent information on medical history, concurrent conditions and concomitant therapies was not provided. On an unknown date, the patient was vaccinated with a dose of GARDASIL 9 (formulation, exact dose, frequency, route of administration, lot # and expiration date were not reported). On an unknown date, the patient experienced an auto immune-mediated adverse reaction. The physician also reported the patient's symptoms suggested postural orthostatic tachycardia syndrome. The outcome of the events was not reported. The causality assessment between the patient's immune-mediated adverse reaction and postural orthostatic tachycardia syndrome with GARDASIL 9 was not provided. Upon internal review, the patient's immune-mediated adverse reaction was considered medically significant. Follow-up information was received from the physician who stated that he had contacted Merck Medical Information (JAN-2018) regarding a request to obtain additional information regarding GARDASIL 9 auto-immune mediated reactions and the GARDASIL 9 but never received a response, and that he would be happy to provide additional information on the adverse event or medical events, once Merck helps him with his request. He also provided additional contact details. It was also reported that, on unknown date, an unknown patient experienced adverse events after receiving GARDASIL 9. Follow up information was received from physician via company representative regarding a female patient of unknown age on 23-AUG-2018. The patient was vaccinated with GARDASIL 9 on an unknown date in December 2017. On an unknown date (reported as 4 days later), the patient developed syncope. Syncope/presyncope was continued for several weeks. On an unknown date, patient was evaluated in cardiology. On an unknown date, the patient was evaluated in emergency room and diagnosed with slight leukocytosis.  On an unknown date after 3 weeks of vaccination, the patient was unable to walk a block, unable to sleep and also experienced burning sensation in brain and core (burning sensation and feeling abnormal), gastrointestinal side effects (gastrointestinal disorder), nausea and vomiting, severe gastric pain, vivid nightmares, weight loss, sleep paralysis and medically withdrawn from school. On an unknown date, the patient was diagnosed with postural orthostatic tachycardia syndrome (POTS) by dysautonomia specialist and told POTS was secondary to GARDASIL 9. It was reported that the patient was quite impaired even after 8 months (not recovered). Causality assessment was not provided.
Sex: F
Vaccine: HPV9
Symptoms: Gastrointestinal disorder, Insomnia, Leukocytosis, Loss of personal independence in daily activities, Nausea
Clinical narrative: This non-valid spontaneous report was received from a physician regarding a patient of unknown age and gender. The patient's pertinent information on medical history, concurrent conditions and concomitant therapies was not provided. On an unknown date, the patient was vaccinated with a dose of GARDASIL 9 (formulation, exact dose, frequency, route of administration, lot # and expiration date were not reported). On an unknown date, the patient experienced an auto immune-mediated adverse reaction. The physician also reported the patient's symptoms suggested postural orthostatic tachycardia syndrome. The outcome of the events was not reported. The causality assessment between the patient's immune-mediated adverse reaction and postural orthostatic tachycardia syndrome with GARDASIL 9 was not provided. Upon internal review, the patient's immune-mediated adverse reaction was considered medically significant. Follow-up information was received from the physician who stated that he had contacted Merck Medical Information (JAN-2018) regarding a request to obtain additional information regarding GARDASIL 9 auto-immune mediated reactions and the GARDASIL 9 but never received a response, and that he would be happy to provide additional information on the adverse event or medical events, once Merck helps him with his request. He also provided additional contact details. It was also reported that, on unknown date, an unknown patient experienced adverse events after receiving GARDASIL 9. Follow up information was received from physician via company representative regarding a female patient of unknown age on 23-AUG-2018. The patient was vaccinated with GARDASIL 9 on an unknown date in December 2017. On an unknown date (reported as 4 days later), the patient developed syncope. Syncope/presyncope was continued for several weeks. On an unknown date, patient was evaluated in cardiology. On an unknown date, the patient was evaluated in emergency room and diagnosed with slight leukocytosis.  On an unknown date after 3 weeks of vaccination, the patient was unable to walk a block, unable to sleep and also experienced burning sensation in brain and core (burning sensation and feeling abnormal), gastrointestinal side effects (gastrointestinal disorder), nausea and vomiting, severe gastric pain, vivid nightmares, weight loss, sleep paralysis and medically withdrawn from school. On an unknown date, the patient was diagnosed with postural orthostatic tachycardia syndrome (POTS) by dysautonomia specialist and told POTS was secondary to GARDASIL 9. It was reported that the patient was quite impaired even after 8 months (not recovered). Causality assessment was not provided.
Sex: F
Vaccine: HPV9
Symptoms: Nightmare, Postural orthostatic tachycardia syndrome, Sleep paralysis, Syncope, Vomiting
Clinical narrative: This non-valid spontaneous report was received from a physician regarding a patient of unknown age and gender. The patient's pertinent information on medical history, concurrent conditions and concomitant therapies was not provided. On an unknown date, the patient was vaccinated with a dose of GARDASIL 9 (formulation, exact dose, frequency, route of administration, lot # and expiration date were not reported). On an unknown date, the patient experienced an auto immune-mediated adverse reaction. The physician also reported the patient's symptoms suggested postural orthostatic tachycardia syndrome. The outcome of the events was not reported. The causality assessment between the patient's immune-mediated adverse reaction and postural orthostatic tachycardia syndrome with GARDASIL 9 was not provided. Upon internal review, the patient's immune-mediated adverse reaction was considered medically significant. Follow-up information was received from the physician who stated that he had contacted Merck Medical Information (JAN-2018) regarding a request to obtain additional information regarding GARDASIL 9 auto-immune mediated reactions and the GARDASIL 9 but never received a response, and that he would be happy to provide additional information on the adverse event or medical events, once Merck helps him with his request. He also provided additional contact details. It was also reported that, on unknown date, an unknown patient experienced adverse events after receiving GARDASIL 9. Follow up information was received from physician via company representative regarding a female patient of unknown age on 23-AUG-2018. The patient was vaccinated with GARDASIL 9 on an unknown date in December 2017. On an unknown date (reported as 4 days later), the patient developed syncope. Syncope/presyncope was continued for several weeks. On an unknown date, patient was evaluated in cardiology. On an unknown date, the patient was evaluated in emergency room and diagnosed with slight leukocytosis.  On an unknown date after 3 weeks of vaccination, the patient was unable to walk a block, unable to sleep and also experienced burning sensation in brain and core (burning sensation and feeling abnormal), gastrointestinal side effects (gastrointestinal disorder), nausea and vomiting, severe gastric pain, vivid nightmares, weight loss, sleep paralysis and medically withdrawn from school. On an unknown date, the patient was diagnosed with postural orthostatic tachycardia syndrome (POTS) by dysautonomia specialist and told POTS was secondary to GARDASIL 9. It was reported that the patient was quite impaired even after 8 months (not recovered). Causality assessment was not provided.
Sex: F
Vaccine: HPV9
Symptoms: Weight decreased
Clinical narrative: This non-valid spontaneous report was received from a physician regarding a patient of unknown age and gender. The patient's pertinent information on medical history, concurrent conditions and concomitant therapies was not provided. On an unknown date, the patient was vaccinated with a dose of GARDASIL 9 (formulation, exact dose, frequency, route of administration, lot # and expiration date were not reported). On an unknown date, the patient experienced an auto immune-mediated adverse reaction. The physician also reported the patient's symptoms suggested postural orthostatic tachycardia syndrome. The outcome of the events was not reported. The causality assessment between the patient's immune-mediated adverse reaction and postural orthostatic tachycardia syndrome with GARDASIL 9 was not provided. Upon internal review, the patient's immune-mediated adverse reaction was considered medically significant. Follow-up information was received from the physician who stated that he had contacted Merck Medical Information (JAN-2018) regarding a request to obtain additional information regarding GARDASIL 9 auto-immune mediated reactions and the GARDASIL 9 but never received a response, and that he would be happy to provide additional information on the adverse event or medical events, once Merck helps him with his request. He also provided additional contact details. It was also reported that, on unknown date, an unknown patient experienced adverse events after receiving GARDASIL 9. Follow up information was received from physician via company representative regarding a female patient of unknown age on 23-AUG-2018. The patient was vaccinated with GARDASIL 9 on an unknown date in December 2017. On an unknown date (reported as 4 days later), the patient developed syncope. Syncope/presyncope was continued for several weeks. On an unknown date, patient was evaluated in cardiology. On an unknown date, the patient was evaluated in emergency room and diagnosed with slight leukocytosis.  On an unknown date after 3 weeks of vaccination, the patient was unable to walk a block, unable to sleep and also experienced burning sensation in brain and core (burning sensation and feeling abnormal), gastrointestinal side effects (gastrointestinal disorder), nausea and vomiting, severe gastric pain, vivid nightmares, weight loss, sleep paralysis and medically withdrawn from school. On an unknown date, the patient was diagnosed with postural orthostatic tachycardia syndrome (POTS) by dysautonomia specialist and told POTS was secondary to GARDASIL 9. It was reported that the patient was quite impaired even after 8 months (not recovered). Causality assessment was not provided.
Sex: F
Vaccine: HPVX
Symptoms: Unevaluable event
Clinical narrative: This spontaneous retrospective pregnancy report was received from a journalist and an unspecified reporter refers to unspecified number of female patients of unknown age. The patients' historical condition, current condition and concomitant medications were not reported. On unknown dates, the patients were vaccinated with quadrivalent human papillomavirus (types 6,11,16,18) recomb. Vaccine (manufacturer unknown) (dose, route, frequency, expiration date and lot number were not specified) or HPV rL1 6 11 16 18 31 33 45 52 58 VLP vaccine (yeast) (manufacturer unknown) (dose, route, frequency, expiration date and lot number were not specified) (reported as human papillomavirus vaccine). Between 2006 and 2014, 48 patients experienced ovarian damage (ovarian injury) associated with autoimmune reactions (autoimmune disorder) with quadrivalent human papillomavirus (types 6,11,16,18) recomb. Vaccine (manufacturer unknown)/ HPV rL1 6 11 16 18 31 33 45 52 58 VLP vaccine (yeast) (manufacturer unknown). Between 2006 and May 2018, 256 patients had spontaneous abortion, 172 patients had amenorrhea and 172 patients had irregular menstruation. Unspecified number of females experienced reduction in fertility. The last menstrual period, due date and date of conception of the patients were not reported. The outcome of the events was unknown. The reporter's causality assessment between the events and the suspect therapies were not reported. Upon internal review, the events autoimmune disorder, ovarian injury and spontaneous abortion were determined to be medically significant. This is one of the several reports from the same reporter.; Sender's Comments: AU-MERCK-1406AUS003919: US-009507513-1808USA012893: US-009507513-1808USA012912:
Age: 20.0
Sex: M
Vaccine: HPV4
Symptoms: Human metapneumovirus test positive
Clinical narrative: Information has been received from a registered nurse referring to a 26 year old male patient. The patient's pertinent medical history, concomitant medication and drug reactions/allergies were reported as none. The patient was vaccinated with GARDASIL (dose, batch#  and expiration date unknown; first dose on 31-AUG-2011, lot number reported as 963AA; second dose on 09-JAN-2012, lot number 1537AA; third dose on 04-AUG-2012, lot number reported as 0629AB) intramuscularly for prophylaxis as scheduled. On 17-JUL-2018, the patient tested positive for Human metapneumovirus (HPV) types 16, 18, 6, 11. On an unspecified date in 2018, the patient received an unspecified form of treatment.  The outcome of the event was reported as recovered on an unknown date in 2018. The patient had sought medical attention and there was no lab diagnostics/studies performed. The causality assessment was not provided by reporter.
Sex: U
Vaccine: MMRV
Symptoms: No adverse event, Product storage error
Clinical narrative: This spontaneous report was received from a medical assistant referring to a patient of unknown age and gender. The patient's pertinent medical history, concomitant medications and drug reactions or allergies were not reported. On 06-AUG-2018, the patient was vaccinated with an unspecified dose of improperly stored PROQUAD (recombinant human albumin (rHA), lot number R006217, expiration date 28-AUG-2019, route of administration was not reported) for prophylaxis. It was reported that sterile diluent (lot number and expiration date were not provided) used for reconstitution of the vaccine was not improperly stored. The vaccine was stored in temperature between 15 and 46 Fahrenheit degrees for 3 hours 30 minutes (date unspecified). Previous temperature excursion was recorded in temperature range of 15 to 46 Fahrenheit degrees for 1 hour 30 minutes (date unspecified). A Digital Data Logger was involved. No adverse effects were reported. This is one of 2 reports received from the same reporter.; Sender's Comments:  US-009507513-1808USA005807:
Age: 1.08
Sex: M
Vaccine: MMR
Symptoms: Rash generalised, Viral rash
Clinical narrative: This spontaneous report as received from a nurse refers to a 14-month-old male patient of unknown age. The patient's medical history, concurrent conditions, and concomitant drugs were not provided. On 20-JUL-2018, the patient was vaccinated with the first dose of M-M-R II 0.5 mL (lot# and expiration date were not reported), subcutaneously, for prophylaxis. Other suspect therapies included sterile diluent (lot# and expiration date were unknown by the reporter). On approximately 31-JUL-2018 (reported as: 11 days after vaccination), the patient developed a full body rash. Subsequently, he went to the emergency room and the physician (unspecified) stated that the patient had a viral rash. He was not admitted to the hospital. The patient was given treatment for the event (details unspecified). It was reported that the rash lasted for 6 days (however, the patient's current status was unknown by the reporter). Lab diagnostics were not performed. The reporter did not provide the causality assessment between M-M-R II, sterile diluent, and the full body viral rash.
Sex: U
Vaccine: RV5
Symptoms: No adverse event, Product storage error
Clinical narrative: This spontaneous report as received from a medical assistant refers to a patient of unknown age and gender. There was no information about the patient's concurrent conditions, concomitant therapies or medical history provided. On 06-AUG-2018, the patient was vaccinated with an improperly stored dose of ROTATEQ, lot # R003114, expiration date 27-SEP-2019 (dose and route of administration were not reported). There was no adverse effect reported. Administered dose of vaccine experienced the temperature excursion of 74 degrees Fahrenheit for 72 hours. Data logger was not involved. There were no previous excursions reported. This is one of several reports received from the same reporter. Sender's Comments: US-009507513-1809USA000365.
Age: 11.0
Sex: M
Vaccine: HPV9, MNQ, TDAP
Symptoms: Urticaria
Clinical narrative: This spontaneous report was received from a nurse and concerns an 11-year-old male patient. The patient had no pertinent medical history and not known drug reactions or allergies. The patient's concomitant medications were not reported. On 02-AUG-2018, the patient was vaccinated with the first dose of GARDASIL 9, 0.5 ml, intramuscularly in the left deltoid (lot# N035032 and expiration date: 24-SEP-2020) for human papilloma virus prevention and with MENACTRA intramuscularly in the left deltoid (lot# U5916AA with expiration date: 27-JUN-2019) (dose not reported) and diphtheria toxoid, pertussis acellular vaccine (unspecified), tetanus toxoid, intramuscularly in the right deltoid (lot# U5850AA with expiration date: 17-JAN-2020) (dose not reported). On 03-AUG-2018, the patient broke out of hives on his torso, abdomen, back and groin, both arms and larger hive on his right arm. The patient's parent spoke with on call nurse. No laboratory diagnostics or studies were performed. The patient received an unspecified treatment. On 05-AUG-2018, the hives subsided. The relatedness between the event and GARDASIL 9, diphtheria toxoid, pertussis acellular vaccine (unspecified), tetanus toxoid and MENACTRA was not reported.
Sex: U
Vaccine: MMRV
Symptoms: No adverse event, Product storage error
Clinical narrative: This spontaneous report was received from a medical assistant referring to a patient of unknown age and gender. The patient's pertinent medical history, concomitant medications and drug reactions or allergies were not reported. On 06-AUG-2018, the patient was vaccinated with an unspecified dose of improperly stored PROQUAD recombinant human albumin (rHA), lot number R006217, expiration date 28-AUG-2019, route of administration was not reported) for prophylaxis. It was reported that sterile diluent (lot number and expiration date were not provided) used for reconstitution of the vaccine was not improperly stored. The vaccine was stored in temperature range between 15 and 46 Fahrenheit degrees for 3 hours 30 minutes (date unspecified). Previous temperature excursion was recorded in temperature range of 15 to 46 Fahrenheit degrees for 1 hour 30 minutes (date unspecified). A Digital Data Logger was involved. No adverse effects were reported. This is one of 2 reports received from the same reporter. Sender's Comments: US-009507513-1808USA003281.
Age: 46.0
Sex: M
Vaccine: HPV9
Symptoms: Drug administered to patient of inappropriate age, No adverse event
Clinical narrative: This spontaneous report was received from a consumer referring to himself, a male patient of 46 years old.  The patient's concurrent, historical medical conditions and concomitant medications, previous drug reactions and allergies were not provided. On unknown date, the reporter indicated that he received GARDASIL 9 (lot number, expiration date, route of administration, were not reported), while he was 46 year old on unspecified date. No adverse effects were reported. The action taken, outcome and causality were not reported.
Age: 3.0
Sex: F
Vaccine: HEPA
Symptoms: Extra dose administered, No adverse event
Clinical narrative: This spontaneous report was received from a physician and refers to a 3-year-old female patient. No information regarding the patient's pertinent medical history, drug reactions or allergies and concomitant medications was provided. On 13-AUG-2018, the patient was inadvertently vaccinated with a third (extra) dose of VAQTA 25/0.5 (units not provided), intramuscularly, lot # N023953 with expiration date on 05-NOV-2018 (dose was not reported) for prophylaxis. No adverse effects were reported.