chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 50.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site erythema, Injection site pain, Injection site swelling, Injection site warmth
Clinical narrative: This spontaneous report as received from a pharmacist refers to a 50 year old female patient. Currently patient was having unspecified pain. No historical medication was reported. On 14-SEP-2014, the patient was vaccinated with ZOSTAVAX lot # K000325 expiration date- 27-FEB-2015, (dose strength was unknown). Concomitantly patient was receiving unspecified narcotic pain relievers. Pharmacist reports that the patient who had ZOSTAVAX administered on 14-SEP-2014, returned to the pharmacy on 15-SEP-2014 with 1.5 by 2 inch red circle around the injection site that was warm, swollen and painful. The outcome of 1.5 by 2 inch red circle around the injection site that was warm, swollen and painful was unknown. Pharmacist recommended cold compresses and Ibuprofen to treat the symptoms. No rash was present. No further information was provided. Lab Diagnostics Studies Performed was reported as none. Sought Medical Attention was reported as Yes, pharmacy visit. No PQC involved. Additional information has been requested.
Age: 70.0
Sex: M
Vaccine: PPV
Symptoms: Incorrect storage of drug, No adverse event
Clinical narrative: This spontaneous report as received form a medical assistant refers to a three unspecified patients of unknown gender and age. In September 2014 (reported as since the temperature event), the patients were vaccinated with a doses of GARDASIL (dose, dose number, route, lot/batch number, expiration date were not reported) that were improperly stored on 08-SEP-2014. No adverse effects were reported. No product quality complaint (PQC) involved. Follow-up information has been received from the reporting medical assistant, who provided patients' identifiers (age and gender), dates of vaccinations and lot numbers. This reports concerns a 70 years old male patient. No information on his medical history, concurrent conditions or concomitant drugs was provided. It was reported that the PNEUMOVAX23 underwent the temperature excursion on 08-AUG-2014. On 21-AUG-2014, the patient received a dose of PNEUMOVAX23 which underwent temperature excursion (dose, site and route of administration unknown; lot# J008799, expiration date 16-APR-2014). This is one of several reports from the same reporter. Additional information has been requested.
Age: 0.19
Sex: F
Vaccine: RV5
Symptoms: Incorrect storage of drug, No adverse event
Clinical narrative: This spontaneous report was received from a healthcare professional who reported that in January 2014, 21 improperly stored doses of ROTATEQ, (oral, dose, batch and lot number not reported) were administered by a clinic to an unspecified number of patients (age and gender were not reported). No adverse effects were reported. This is one of several reports from the same source. Follow up information has been received on 17-MAR-2014. All telephone attempts to obtain follow-up information had been unsuccessful. Follow up information has been received on 22-SEP-2014. Demographic details for each patient were provided. This report referred to a 4-months old female patient, with no known drug allergies and no illness at time of vaccination. The patient was vaccinated with an unspecified dose of ROTATEQ (oral, batch/lot # J004875, expiration date 17-OCT-2014), on 04-FEB-2014. It was reported that this dose was spoiled since the refrigerator was too cold (onset of event also reported as 27-FEB-2014 at 10:00 AM). The parents of the patient never called back and were going to consult with physician. No adverse event was reported for the patient. This is one of several reports from the same source. Additional information is not expected since all follow ups requested to complete the case were received.
Age: 61.0
Sex: F
Vaccine: FLU3, VARZOS
Symptoms: Injection site rash
Clinical narrative: Rash over injection.
Age: 4.0
Sex: M
Vaccine: FLU4
Symptoms: Injection site erythema, Injection site swelling
Clinical narrative: Site reaction: redness, "fist sized" swelling.
Age: 66.0
Sex: F
Vaccine: FLU3
Symptoms: Dizziness, Headache, Local swelling, Pain in extremity
Clinical narrative: Swollen arm, severe headache, dizziness, sore leg started later that day and through the next day took TYLENOL, BENADRYL and iced the area.
Age: 83.0
Sex: F
Vaccine: FLU3
Symptoms: Erythema, Pruritus, Skin warm
Clinical narrative: Patient had a large, warm red area on her right arm - about 4 inches in diameter. She stated that the area was itchy.
Age: 0.48
Sex: F
Vaccine: RV5
Symptoms: Incorrect storage of drug, No adverse event
Clinical narrative: This spontaneous report was received from a healthcare professional who reported that in January 2014, 21 improperly stored doses of ROTATEQ, (oral, dose, batch and lot number not reported) were administered by a clinic to an unspecified number of patients (age and gender were not reported). No adverse effects were reported. This is one of several reports from the same source. Follow up information has been received on 17-MAR-2014. All telephone attempts to obtain follow-up information had been unsuccessful. Follow up information has been received on 22-SEP-2014. Demographic details for each patient were provided. This report referred to an 8-months old female patient, with no known drug allergies and no illness at time of vaccination. The patient was vaccinated with the third dose of ROTATEQ (oral, batch/lot # J004875, expiration date 17-OCT-2014) on 15-JAN-2014 in the afternoon. It was reported that this dose was spoiled since the refrigerator was too cold (onset of event also reported as 27-FEB-2014 at 10:00 AM). The parents of the patient were going to consult with physician and declined to repeat the dose. No adverse event was reported for the patient. This is one of several reports from the same source. Additional information is not expected since all follow ups requested to complete the case were received.
Age: 56.0
Sex: M
Vaccine: FLU3, VARZOS
Symptoms: Glossodynia, Injection site pain, Injection site rash, Injection site warmth, Swollen tongue
Clinical narrative: About 40 hrs after pt developed warm, sore, rash at injection site (gave reassurance) plus tongue sore like a "charlie-horse" w/swelling and wheeze (-) SOB,  with BENADRYL - resolved w/in 12 hrs.
Age: 56.0
Sex: M
Vaccine: FLU3, VARZOS
Symptoms: Wheezing
Clinical narrative: About 40 hrs after pt developed warm, sore, rash at injection site (gave reassurance) plus tongue sore like a "charlie-horse" w/swelling and wheeze (-) SOB,  with BENADRYL - resolved w/in 12 hrs.
Age: 7.0
Sex: M
Vaccine: FLUN4
Symptoms: Abdominal pain upper, Nasal congestion, Rash, Respiratory tract congestion
Clinical narrative: Patient received FLUMIST on 9/26/14. The following day he had a stomach ache, congestion, stuffy nose and he broke out in a rash.
Sex: U
Vaccine: VARZOS
Symptoms: Herpes zoster
Clinical narrative: This spontaneous report was received from a pharmacist refers to a patient of unknown age and gender. Patient's historical condition and concurrent condition were not reported. On an unspecified date in 2001, the patient was vaccinated with ZOSTAVAX, 0.65 ml (route and lot # were not reported). Concomitant therapies were not provided. On an unknown date in 2014, the patient experienced three out breaks of shingles on an unspecified dates since receiving the ZOSTAVAX. The outcome of three out breaks of shingles was unknown. Additional information has been requested.
Age: 72.0
Sex: F
Vaccine: FLU3, PPV
Symptoms: Asthenia, Erythema, Hypersensitivity, Local swelling, Pain
Clinical narrative: Patient feels weak, achy, feverish and vomited within hours of administration. (R) arm is also red and swollen. Iced arm and took ALEVE. Went to MD on 9/29 and was treated with OTC ZYRTEC and MEDROL dose pack for allergic reaction. Reaction progressed down arm as it got better.
Age: 72.0
Sex: F
Vaccine: FLU3, PPV
Symptoms: Pyrexia, Vomiting
Clinical narrative: Patient feels weak, achy, feverish and vomited within hours of administration. (R) arm is also red and swollen. Iced arm and took ALEVE. Went to MD on 9/29 and was treated with OTC ZYRTEC and MEDROL dose pack for allergic reaction. Reaction progressed down arm as it got better.
Sex: U
Vaccine: RV5
Symptoms: Incorrect storage of drug, No adverse event
Clinical narrative: This spontaneous report as received from a Licensed Practical Nurse refers to 6 patients of unknown age and gender. On an unknown date, the patients were vaccinated with single dose of ROTATEQ (lot # J011344 exp 10-MAY-2015) that were improperly stored. No adverse effects were reported. Additional information is not expected. The reporter does not want to be contacted.
Age: 82.0
Sex: M
Vaccine: FLU3
Symptoms: Activities of daily living impaired, Erythema, Hot flush, Pain, Skin warm
Clinical narrative: HIGH DOSEinfluenza given 9-22-14 at health dept. Wife got her HIGH DOSE vaccine at same visit. He was "fine" day of vaccine. Had trouble getting out of bed 9-23-14. Morning, was achy all over. Felt like back of neck/head was swollen/hot to touch. Had red spot near (L) temple which is gone 9-29-14. But now has red (L) face cheek. States had "bad day - achy" 9-23-14 and most of 9-24-14. He happen to have appt with his doctor at hospital 9-23-14 for some lower abd pain he's been having off and on B/p was ok no fever, no numbness/tingling of extremities. No headache. Site of injection was never sore/swollen or red (9-29-14 re checked of site asymptomatic). Reconfirmed - no allergies to eggs or gelatin. He states "back of head/neck area felt sunburnt and swollen" felt like hot flashes at back of my head. I told him I would contact him on/around 10-6-14 (2 2weeks after injection) to reassess. He will call me if any further s/s occur. Today is 7 days post vaccination and he is ambulatory, all s/s he had 9-23-14/9/24/14 have resolved. He is alert/oriented, pleasant.
Age: 82.0
Sex: M
Vaccine: FLU3
Symptoms: Swelling
Clinical narrative: HIGH DOSEinfluenza given 9-22-14 at health dept. Wife got her HIGH DOSE vaccine at same visit. He was "fine" day of vaccine. Had trouble getting out of bed 9-23-14. Morning, was achy all over. Felt like back of neck/head was swollen/hot to touch. Had red spot near (L) temple which is gone 9-29-14. But now has red (L) face cheek. States had "bad day - achy" 9-23-14 and most of 9-24-14. He happen to have appt with his doctor at hospital 9-23-14 for some lower abd pain he's been having off and on B/p was ok no fever, no numbness/tingling of extremities. No headache. Site of injection was never sore/swollen or red (9-29-14 re checked of site asymptomatic). Reconfirmed - no allergies to eggs or gelatin. He states "back of head/neck area felt sunburnt and swollen" felt like hot flashes at back of my head. I told him I would contact him on/around 10-6-14 (2 2weeks after injection) to reassess. He will call me if any further s/s occur. Today is 7 days post vaccination and he is ambulatory, all s/s he had 9-23-14/9/24/14 have resolved. He is alert/oriented, pleasant.
Age: 0.35
Sex: M
Vaccine: RV5
Symptoms: Incorrect storage of drug, No adverse event
Clinical narrative: This spontaneous report was received from a healthcare professional who reported that in January 2014, 21 improperly stored doses of ROTATEQ, (oral, dose, batch and lot number not reported) were administered by a clinic to an unspecified number of patients (age and gender were not reported). No adverse effects were reported. This is one of several reports from the same source. Follow up information has been received on 17-MAR-2014. All telephone attempts to obtain follow-up information had been unsuccessful. Follow up information has been received on 22-SEP-2014. Demographic details for each patient were provided. This report referred to a 6-months old male patient, with no known drug allergies and no illness at time of vaccination. The patient was vaccinated with the second dose of ROTATEQ (oral, batch/lot # J004875, expiration date 17-OCT-2014), on 13-JAN-2014 in the afternoon. It was reported that this dose was spoiled since the refrigerator was too cold (onset of event also reported as 27-FEB-2014 at 10:00 AM). Parents were going to consult the physician and declined to revaccinate. No adverse event was reported for the patient. The reporter reported the outcome as unknown. This is one of several reports from the same source. Additional information is not expected since all follow ups requested to complete the case were received.
Age: 34.0
Sex: F
Vaccine: FLU3, PPV
Symptoms: Erythema, Pain, Skin infection, Swelling
Clinical narrative: Red, swollen, pain, pt went to ER for skin infection pt received antibiotic.
Age: 66.0
Sex: F
Vaccine: FLU3
Symptoms: Contusion, Erythema, Local swelling
Clinical narrative: Red, bruised, swollen upper arm.
Age: 24.0
Sex: F
Vaccine: FLU3
Symptoms: Discomfort, Hypoaesthesia, Injection site erythema, Injection site pruritus, Injection site warmth
Clinical narrative: All over uneasy/unwell feeling w/in 2 hours of vaccine. Temp 101.4 degrees. 1 1/2" red, warm, spot at area of injection itchy very bad. Tingling, numbness down arm of injection.
Age: 24.0
Sex: F
Vaccine: FLU3
Symptoms: Malaise, Paraesthesia
Clinical narrative: All over uneasy/unwell feeling w/in 2 hours of vaccine. Temp 101.4 degrees. 1 1/2" red, warm, spot at area of injection itchy very bad. Tingling, numbness down arm of injection.
Age: 68.0
Sex: F
Vaccine: FLU3
Symptoms: Arthralgia, Injection site erythema, Injection site swelling, Joint crepitation, Joint swelling
Clinical narrative: 9/24 (morning after vaccination) pt woke up with pain and swelling of knuckles of left hand; mainly middle and ring finger. Her left elbow was also "creaky", upper left arm was also red and somewhat swollen. Reported to pharmacy on 9/26, mostly resolved but knuckles still a bit swollen. As of 9/29 pm patient says swelling and pain resolved.
Age: 65.0
Sex: F
Vaccine: FLU3
Symptoms: Injection site erythema, Injection site urticaria
Clinical narrative: Patient is complaining of a large red welt a couple inches in diameter at the injection site.
Sex: F
Vaccine: HPV4, HPV4
Symptoms: Abdominal pain upper, Drug label confusion, Flatulence, Pain, Pain in extremity
Clinical narrative: This spontaneous report as received from a currently 46 year old female patient reporting on herself. The patient's concurrent conditions included polycystic ovary syndrome, Human Papilloma Virus (HPV) and no drug reaction/allergies. On unknown dates, the patient was vaccinated with doses 1, 2 and 3 of GARDASIL (dose, route, lot numbers and expiration dates were not reported). The patient was not taking concomitant medications. The patient reported, "I had stinging pain that runs through my body and I had experienced stomach pains after I received all 3 shots of GARDASIL" (onset dates unknown). The patient then explained, "I had HPV before receiving all 3 shots of GARDASIL and I wish I could get more shots because this helped me." The patient provided further information: "although I felt relief from the HPV running in my body after I received all 3 shots of GARDASIL, my stomach pain was so bad that I want to kill myself" and "after receiving my third dose of GARDASIL I had experienced tremendous gas." (Date unknown). The patient also reported she experienced "throbbing in her left leg," (date unknown) however the throbbing had "gone down after receiving the third dose." the patient stated "the vaccine seems to be working, because toxins are being released from my body". No lab diagnostics were performed. Outcome of stinging body pain, stomach pain, "wanted to kill herself" and tremendous gas was unknown at the time of the report. Outcome of throbbing in left leg was recovering at the time of the report. Relatedness between all the events and GARDASIL was not reported. Upon internal review the event: "wanted to kill myself" was considered to be medically significant. Follow-up information was received from the patient. The patient reported that when she was diagnosed with HPV (date unknown) she had elevated blood pressures (unknown dates). She reported on 29-MAY-2014, that her blood pressure was back to normal. Follow-up information was received from the patient. It was reported she felt that the GARDASIL was definitely helping her and she just wanted to check in again. She stated that on 28-MAR-2014 she had cited that she was experiencing stomach pain on unspecified dates. She wanted to clarify that she believed that it was due to raw garlic that she had started to take on unspecified dates. She stated that it was not due to the GARDASIL. She stopped taking the raw garlic on an unspecified date and the stomach pain went away on an unspecified date. She did however have unusual headaches on unspecified dates. Outcome of unusual headache was unknown. Relatedness between unusual headaches and GARDASIL was not reported. Follow up information was received. It was reported that after third shot pain have decrease and "decrease with each shot". Additional information has been requested.
Sex: F
Vaccine: HPV4, HPV4
Symptoms: Suicidal ideation, Wrong drug administered
Clinical narrative: This spontaneous report as received from a currently 46 year old female patient reporting on herself. The patient's concurrent conditions included polycystic ovary syndrome, Human Papilloma Virus (HPV) and no drug reaction/allergies. On unknown dates, the patient was vaccinated with doses 1, 2 and 3 of GARDASIL (dose, route, lot numbers and expiration dates were not reported). The patient was not taking concomitant medications. The patient reported, "I had stinging pain that runs through my body and I had experienced stomach pains after I received all 3 shots of GARDASIL" (onset dates unknown). The patient then explained, "I had HPV before receiving all 3 shots of GARDASIL and I wish I could get more shots because this helped me." The patient provided further information: "although I felt relief from the HPV running in my body after I received all 3 shots of GARDASIL, my stomach pain was so bad that I want to kill myself" and "after receiving my third dose of GARDASIL I had experienced tremendous gas." (Date unknown). The patient also reported she experienced "throbbing in her left leg," (date unknown) however the throbbing had "gone down after receiving the third dose." the patient stated "the vaccine seems to be working, because toxins are being released from my body". No lab diagnostics were performed. Outcome of stinging body pain, stomach pain, "wanted to kill herself" and tremendous gas was unknown at the time of the report. Outcome of throbbing in left leg was recovering at the time of the report. Relatedness between all the events and GARDASIL was not reported. Upon internal review the event: "wanted to kill myself" was considered to be medically significant. Follow-up information was received from the patient. The patient reported that when she was diagnosed with HPV (date unknown) she had elevated blood pressures (unknown dates). She reported on 29-MAY-2014, that her blood pressure was back to normal. Follow-up information was received from the patient. It was reported she felt that the GARDASIL was definitely helping her and she just wanted to check in again. She stated that on 28-MAR-2014 she had cited that she was experiencing stomach pain on unspecified dates. She wanted to clarify that she believed that it was due to raw garlic that she had started to take on unspecified dates. She stated that it was not due to the GARDASIL. She stopped taking the raw garlic on an unspecified date and the stomach pain went away on an unspecified date. She did however have unusual headaches on unspecified dates. Outcome of unusual headache was unknown. Relatedness between unusual headaches and GARDASIL was not reported. Follow up information was received. It was reported that after third shot pain have decrease and "decrease with each shot". Additional information has been requested.
Sex: F
Vaccine: HPV4, HPV4
Symptoms: Abdominal pain upper, Blood pressure increased, Flatulence, Headache, Pain
Clinical narrative: This spontaneous report as received from a currently 46 year old female patient reporting on herself. The patient's concurrent conditions included polycystic ovary syndrome, Human Papilloma Virus (HPV) and no drug reaction/allergies. On unknown dates, the patient was vaccinated with doses 1, 2 and 3 of GARDASIL (dose, route, lot numbers and expiration dates were not reported). The patient was not taking concomitant medications. The patient reported, "I had stinging pain that runs through my body and I had experienced stomach pains after I received all 3 shots of GARDASIL" (onset dates unknown). The patient then explained, "I had HPV before receiving all 3 shots of GARDASIL and I wish I could get more shots because this helped me." The patient provided further information: "although I felt relief from the HPV running in my body after I received all 3 shots of GARDASIL, my stomach pain was so bad that I want to kill myself" and "after receiving my third dose of GARDASIL I had experienced tremendous gas." (Date unknown). The patient also reported she experienced "throbbing in her left leg," (date unknown) however the throbbing had "gone down after receiving the third dose." the patient stated "the vaccine seems to be working, because toxins are being released from my body". No lab diagnostics were performed. Outcome of stinging body pain, stomach pain, "wanted to kill herself" and tremendous gas was unknown at the time of the report. Outcome of throbbing in left leg was recovering at the time of the report. Relatedness between all the events and GARDASIL was not reported. Upon internal review the event: "wanted to kill myself" was considered to be medically significant. Follow-up information was received from the patient. The patient reported that when she was diagnosed with HPV (date unknown) she had elevated blood pressures (unknown dates). She reported on 29-MAY-2014, that her blood pressure was back to normal. Follow-up information was received from the patient. It was reported she felt that the GARDASIL was definitely helping her and she just wanted to check in again. She stated that on 28-MAR-2014 she had cited that she was experiencing stomach pain on unspecified dates. She wanted to clarify that she believed that it was due to raw garlic that she had started to take on unspecified dates. She stated that it was not due to the GARDASIL. She stopped taking the raw garlic on an unspecified date and the stomach pain went away on an unspecified date. She did however have unusual headaches on unspecified dates. Outcome of unusual headache was unknown. Relatedness between unusual headaches and GARDASIL was not reported. Follow up information was received. It was reported that after third shot pain have decrease and "decrease with each shot". Additional information has been requested.
Sex: F
Vaccine: HPV4, HPV4
Symptoms: Pain in extremity, Papilloma viral infection, Suicidal ideation
Clinical narrative: This spontaneous report as received from a currently 46 year old female patient reporting on herself. The patient's concurrent conditions included polycystic ovary syndrome, Human Papilloma Virus (HPV) and no drug reaction/allergies. On unknown dates, the patient was vaccinated with doses 1, 2 and 3 of GARDASIL (dose, route, lot numbers and expiration dates were not reported). The patient was not taking concomitant medications. The patient reported, "I had stinging pain that runs through my body and I had experienced stomach pains after I received all 3 shots of GARDASIL" (onset dates unknown). The patient then explained, "I had HPV before receiving all 3 shots of GARDASIL and I wish I could get more shots because this helped me." The patient provided further information: "although I felt relief from the HPV running in my body after I received all 3 shots of GARDASIL, my stomach pain was so bad that I want to kill myself" and "after receiving my third dose of GARDASIL I had experienced tremendous gas." (Date unknown). The patient also reported she experienced "throbbing in her left leg," (date unknown) however the throbbing had "gone down after receiving the third dose." the patient stated "the vaccine seems to be working, because toxins are being released from my body". No lab diagnostics were performed. Outcome of stinging body pain, stomach pain, "wanted to kill herself" and tremendous gas was unknown at the time of the report. Outcome of throbbing in left leg was recovering at the time of the report. Relatedness between all the events and GARDASIL was not reported. Upon internal review the event: "wanted to kill myself" was considered to be medically significant. Follow-up information was received from the patient. The patient reported that when she was diagnosed with HPV (date unknown) she had elevated blood pressures (unknown dates). She reported on 29-MAY-2014, that her blood pressure was back to normal. Follow-up information was received from the patient. It was reported she felt that the GARDASIL was definitely helping her and she just wanted to check in again. She stated that on 28-MAR-2014 she had cited that she was experiencing stomach pain on unspecified dates. She wanted to clarify that she believed that it was due to raw garlic that she had started to take on unspecified dates. She stated that it was not due to the GARDASIL. She stopped taking the raw garlic on an unspecified date and the stomach pain went away on an unspecified date. She did however have unusual headaches on unspecified dates. Outcome of unusual headache was unknown. Relatedness between unusual headaches and GARDASIL was not reported. Follow up information was received. It was reported that after third shot pain have decrease and "decrease with each shot". Additional information has been requested.
Age: 60.0
Sex: F
Vaccine: VARZOS, VARZOS
Symptoms: Discomfort, Injection site inflammation, Injection site rash, Pain
Clinical narrative: This spontaneous report as received from a pharmacist refers to a 60 year old female patient. No illness occurred at the time of vaccination. On 14-JUL-2014 the patient was vaccinated with the first dose of ZOSTAVAX (lot#, expiration date, dose unspecified), subcutaneous in deltoid. On 15-JUL-2014 07:00 AM, the patient experienced injection site reaction, injection site was inflamed, a rash that continued to grow out, pain and discomfort. The reporter had not reported this adverse event previously. The events outcome was unknown. Emergency room/ doctor visit was required. Additional information has been requested.
Age: 60.0
Sex: F
Vaccine: VARZOS, VARZOS
Symptoms: Discomfort, Injection site inflammation, Pain, Rash
Clinical narrative: This spontaneous report as received from a pharmacist refers to a 60 year old female patient. No illness occurred at the time of vaccination. On 14-JUL-2014 the patient was vaccinated with the first dose of ZOSTAVAX (lot#, expiration date, dose unspecified), subcutaneous in deltoid. On 15-JUL-2014 07:00 AM, the patient experienced injection site reaction, injection site was inflamed, a rash that continued to grow out, pain and discomfort. The reporter had not reported this adverse event previously. The events outcome was unknown. Emergency room/ doctor visit was required. Additional information has been requested.
Age: 12.0
Sex: F
Vaccine: HPV4, HPV4, HPVX, HPV4, HPV4
Symptoms: Cardio-respiratory arrest, Death
Clinical narrative: This spontaneous report as received via social media refers to a 12 year old female patient (it was reported that the girl was fun-loving prior to her death). No concomitant medication, laboratory results or medical history were provided. On 07 August (year not reported), during the morning hours, around 10:30am, the patient was vaccinated with the first dose of GARDASIL dose, indication, lot# and expiration date, route of administration and indication were not provided. It was reported that at the time of vaccination the patient had a sore throat. On 07 August (year not reported), about 30 minutes after receiving GARDASIL, the patient started repeatedly falling into a deep sleep, the patient's mother recalls having had to repeatedly wake her up so she could make it through the day. Later that afternoon, the patient's mother found her lying on the floor unconscious, upon which she initiated CPR (Cardio Pulmonary Resuscitation), the CPR failed, the patient was taken to the hospital, but the patient was dead upon arrival. The date of death was reported as 07 August (year not reported). The relatedness between GARDASIL and the event was not reported. Medical establishment claims that it was a fluke. Regarding sore throat (it was reported that was a minor ailment that, in light of the events of that fateful day, could not possible have killed her that quickly or coincidentally). Additional information is not expected.
Age: 12.0
Sex: F
Vaccine: HPV4, HPV4, HPVX, HPV4, HPV4
Symptoms: Death, Fall, Pulse absent, Respiratory arrest, Skin warm
Clinical narrative: This spontaneous report as received via social media refers to a 12 year old female patient (it was reported that the girl was fun-loving prior to her death). No concomitant medication, laboratory results or medical history were provided. On 07 August (year not reported), during the morning hours, around 10:30am, the patient was vaccinated with the first dose of GARDASIL dose, indication, lot# and expiration date, route of administration and indication were not provided. It was reported that at the time of vaccination the patient had a sore throat. On 07 August (year not reported), about 30 minutes after receiving GARDASIL, the patient started repeatedly falling into a deep sleep, the patient's mother recalls having had to repeatedly wake her up so she could make it through the day. Later that afternoon, the patient's mother found her lying on the floor unconscious, upon which she initiated CPR (Cardio Pulmonary Resuscitation), the CPR failed, the patient was taken to the hospital, but the patient was dead upon arrival. The date of death was reported as 07 August (year not reported). The relatedness between GARDASIL and the event was not reported. Medical establishment claims that it was a fluke. Regarding sore throat (it was reported that was a minor ailment that, in light of the events of that fateful day, could not possible have killed her that quickly or coincidentally). Additional information is not expected.
Age: 12.0
Sex: F
Vaccine: HPV4, HPV4, HPVX, HPV4, HPV4
Symptoms: Somnolence, Vomiting
Clinical narrative: This spontaneous report as received via social media refers to a 12 year old female patient (it was reported that the girl was fun-loving prior to her death). No concomitant medication, laboratory results or medical history were provided. On 07 August (year not reported), during the morning hours, around 10:30am, the patient was vaccinated with the first dose of GARDASIL dose, indication, lot# and expiration date, route of administration and indication were not provided. It was reported that at the time of vaccination the patient had a sore throat. On 07 August (year not reported), about 30 minutes after receiving GARDASIL, the patient started repeatedly falling into a deep sleep, the patient's mother recalls having had to repeatedly wake her up so she could make it through the day. Later that afternoon, the patient's mother found her lying on the floor unconscious, upon which she initiated CPR (Cardio Pulmonary Resuscitation), the CPR failed, the patient was taken to the hospital, but the patient was dead upon arrival. The date of death was reported as 07 August (year not reported). The relatedness between GARDASIL and the event was not reported. Medical establishment claims that it was a fluke. Regarding sore throat (it was reported that was a minor ailment that, in light of the events of that fateful day, could not possible have killed her that quickly or coincidentally). Additional information is not expected.
Age: 12.0
Sex: F
Vaccine: HPV4, HPV4, HPVX, HPV4, HPV4
Symptoms: Death
Clinical narrative: This spontaneous report as received via social media refers to a 12 year old female patient (it was reported that the girl was fun-loving prior to her death). No concomitant medication, laboratory results or medical history were provided. On 07 August (year not reported), during the morning hours, around 10:30am, the patient was vaccinated with the first dose of GARDASIL dose, indication, lot# and expiration date, route of administration and indication were not provided. It was reported that at the time of vaccination the patient had a sore throat. On 07 August (year not reported), about 30 minutes after receiving GARDASIL, the patient started repeatedly falling into a deep sleep, the patient's mother recalls having had to repeatedly wake her up so she could make it through the day. Later that afternoon, the patient's mother found her lying on the floor unconscious, upon which she initiated CPR (Cardio Pulmonary Resuscitation), the CPR failed, the patient was taken to the hospital, but the patient was dead upon arrival. The date of death was reported as 07 August (year not reported). The relatedness between GARDASIL and the event was not reported. Medical establishment claims that it was a fluke. Regarding sore throat (it was reported that was a minor ailment that, in light of the events of that fateful day, could not possible have killed her that quickly or coincidentally). Additional information is not expected.
Age: 12.0
Sex: F
Vaccine: HPV4, HPV4, HPVX, HPV4, HPV4
Symptoms: Autopsy, Death, Unresponsive to stimuli
Clinical narrative: This spontaneous report as received via social media refers to a 12 year old female patient (it was reported that the girl was fun-loving prior to her death). No concomitant medication, laboratory results or medical history were provided. On 07 August (year not reported), during the morning hours, around 10:30am, the patient was vaccinated with the first dose of GARDASIL dose, indication, lot# and expiration date, route of administration and indication were not provided. It was reported that at the time of vaccination the patient had a sore throat. On 07 August (year not reported), about 30 minutes after receiving GARDASIL, the patient started repeatedly falling into a deep sleep, the patient's mother recalls having had to repeatedly wake her up so she could make it through the day. Later that afternoon, the patient's mother found her lying on the floor unconscious, upon which she initiated CPR (Cardio Pulmonary Resuscitation), the CPR failed, the patient was taken to the hospital, but the patient was dead upon arrival. The date of death was reported as 07 August (year not reported). The relatedness between GARDASIL and the event was not reported. Medical establishment claims that it was a fluke. Regarding sore throat (it was reported that was a minor ailment that, in light of the events of that fateful day, could not possible have killed her that quickly or coincidentally). Additional information is not expected.
Age: 12.0
Sex: F
Vaccine: HPV4, HPV4, HPVX, HPV4, HPV4
Symptoms: Death, Hypersomnia, Loss of consciousness, Resuscitation, Somnolence
Clinical narrative: This spontaneous report as received via social media refers to a 12 year old female patient (it was reported that the girl was fun-loving prior to her death). No concomitant medication, laboratory results or medical history were provided. On 07 August (year not reported), during the morning hours, around 10:30am, the patient was vaccinated with the first dose of GARDASIL dose, indication, lot# and expiration date, route of administration and indication were not provided. It was reported that at the time of vaccination the patient had a sore throat. On 07 August (year not reported), about 30 minutes after receiving GARDASIL, the patient started repeatedly falling into a deep sleep, the patient's mother recalls having had to repeatedly wake her up so she could make it through the day. Later that afternoon, the patient's mother found her lying on the floor unconscious, upon which she initiated CPR (Cardio Pulmonary Resuscitation), the CPR failed, the patient was taken to the hospital, but the patient was dead upon arrival. The date of death was reported as 07 August (year not reported). The relatedness between GARDASIL and the event was not reported. Medical establishment claims that it was a fluke. Regarding sore throat (it was reported that was a minor ailment that, in light of the events of that fateful day, could not possible have killed her that quickly or coincidentally). Additional information is not expected.
Sex: F
Vaccine: HPV4, HPV4, HPV4
Symptoms: Full blood count abnormal, Idiopathic thrombocytopenic purpura, Platelet count decreased
Clinical narrative: This spontaneous report was received from a physician via a company representative refers to a female patient of unknown age. No drug allergies reported. On an unknown date, the patient was vaccinated with first dose of GARDASIL injection 120 Y [lot #J013324] expiry date 12-FEB-2016, 0.5 milliliter (ml) (reported as prescribed), intramuscular (IM), (reported as prescribed) and second dose of GARDASIL [lot # K001500, expiry date 06-NOV-2016] 0.5 ml IM (dose unspecified). No other concomitant therapies reported. On an unknown date approximately in 2014 (stop date of the therapy was reported as 11-JUL-2014), the patient experienced ITP (Idiopathic thrombocytopenic purpura) (medically significant). It was reported that the patient experienced an adverse reaction one month after receiving the second dose of GARDASIL. The patient sought medical attention from the primary physician who then referred the patient to a hematologist. The unspecified hematologist reported the diagnosis for the patient's adverse experience as ITP (Idiopathic thrombocytopenic purpura) and also reported low platelet count on an unknown date approximately in 2014. The patient was treated with prednisone (manufacturer unknown) for adverse events. No laboratory test were performed. The outcome of the events was unknown. The causality of the events was unspecified. No product quality complaint (PQC) reported. Upon internal review the event ITP (Idiopathic thrombocytopenic purpura) was considered as medically significant. Additional information has been requested.
Sex: F
Vaccine: HPV4, HPV4, HPV4
Symptoms: Idiopathic thrombocytopenic purpura, Immunoglobulin therapy, Malaise, Platelet count decreased
Clinical narrative: This spontaneous report was received from a physician via a company representative refers to a female patient of unknown age. No drug allergies reported. On an unknown date, the patient was vaccinated with first dose of GARDASIL injection 120 Y [lot #J013324] expiry date 12-FEB-2016, 0.5 milliliter (ml) (reported as prescribed), intramuscular (IM), (reported as prescribed) and second dose of GARDASIL [lot # K001500, expiry date 06-NOV-2016] 0.5 ml IM (dose unspecified). No other concomitant therapies reported. On an unknown date approximately in 2014 (stop date of the therapy was reported as 11-JUL-2014), the patient experienced ITP (Idiopathic thrombocytopenic purpura) (medically significant). It was reported that the patient experienced an adverse reaction one month after receiving the second dose of GARDASIL. The patient sought medical attention from the primary physician who then referred the patient to a hematologist. The unspecified hematologist reported the diagnosis for the patient's adverse experience as ITP (Idiopathic thrombocytopenic purpura) and also reported low platelet count on an unknown date approximately in 2014. The patient was treated with prednisone (manufacturer unknown) for adverse events. No laboratory test were performed. The outcome of the events was unknown. The causality of the events was unspecified. No product quality complaint (PQC) reported. Upon internal review the event ITP (Idiopathic thrombocytopenic purpura) was considered as medically significant. Additional information has been requested.
Sex: F
Vaccine: HPV4, HPV4, HPV4
Symptoms: Idiopathic thrombocytopenic purpura, Platelet count decreased
Clinical narrative: This spontaneous report was received from a physician via a company representative refers to a female patient of unknown age. No drug allergies reported. On an unknown date, the patient was vaccinated with first dose of GARDASIL injection 120 Y [lot #J013324] expiry date 12-FEB-2016, 0.5 milliliter (ml) (reported as prescribed), intramuscular (IM), (reported as prescribed) and second dose of GARDASIL [lot # K001500, expiry date 06-NOV-2016] 0.5 ml IM (dose unspecified). No other concomitant therapies reported. On an unknown date approximately in 2014 (stop date of the therapy was reported as 11-JUL-2014), the patient experienced ITP (Idiopathic thrombocytopenic purpura) (medically significant). It was reported that the patient experienced an adverse reaction one month after receiving the second dose of GARDASIL. The patient sought medical attention from the primary physician who then referred the patient to a hematologist. The unspecified hematologist reported the diagnosis for the patient's adverse experience as ITP (Idiopathic thrombocytopenic purpura) and also reported low platelet count on an unknown date approximately in 2014. The patient was treated with prednisone (manufacturer unknown) for adverse events. No laboratory test were performed. The outcome of the events was unknown. The causality of the events was unspecified. No product quality complaint (PQC) reported. Upon internal review the event ITP (Idiopathic thrombocytopenic purpura) was considered as medically significant. Additional information has been requested.
Age: 37.0
Sex: M
Vaccine: SMALL
Symptoms: Chest discomfort, Cold sweat, Dizziness postural, Erythema, Night sweats
Clinical narrative: Tight chest, sleepy (slept for days), body sore, back especially, dizzy when standing, cold sweets, night sweats, wound looked infected as it was big, full of pus, large red mark around shoulder.
Age: 37.0
Sex: M
Vaccine: SMALL
Symptoms: Pain, Rash pustular, Somnolence
Clinical narrative: Tight chest, sleepy (slept for days), body sore, back especially, dizzy when standing, cold sweets, night sweats, wound looked infected as it was big, full of pus, large red mark around shoulder.
Age: 66.0
Sex: F
Vaccine: VARZOS
Symptoms: Blister, Pain, Pruritus, Rash erythematous
Clinical narrative: Patient noticed that she had three red "bumps" on her left buttocks the day after the vaccine.  At first she believed these were some type of bug bite.  Approximately three days later they developed into water blisters.  Patient also reports two bumps on left inner labia but she does not know if these are also blistered.  She reports that these areas are very itchy and painful.
Age: 66.0
Sex: F
Vaccine: FLU3, PPV
Symptoms: Dizziness, Fatigue, Feeling abnormal, Vomiting
Clinical narrative: Patient began to experience dizziness around dinner time on date of vaccination.  Later in the evening patient began vomiting and had extreme fatigue, reports she was in bed Friday, Saturday, and Sunday post-vaccination.  Vomiting lasted approximately two days, dizziness and fatigue all three days.  Patient reported she felt poorly enough she would have gone to the ED actually but did not have anyone to take care of her pets had she been admitted.
Age: 60.0
Sex: F
Vaccine: FLU4
Symptoms: Asthenia, Cough, Impaired driving ability, Pyrexia, Secretion discharge
Clinical narrative: Low grade fever, excessive mucus leading to vomiting and weakness, on going cough. I had to call in sick on 9-26-14 too weak to drive to work.
Age: 60.0
Sex: F
Vaccine: FLU4
Symptoms: Vomiting
Clinical narrative: Low grade fever, excessive mucus leading to vomiting and weakness, on going cough. I had to call in sick on 9-26-14 too weak to drive to work.
Age: 32.0
Sex: F
Vaccine: FLU4
Symptoms: Abdominal pain, Chills, Diarrhoea, Loss of consciousness, Urticaria
Clinical narrative: Woke up at 1:30am on 09/27/14 with hives, chills, diarrhea, and severe abdominal pain. Passed out twice at home, blood pressure performed by EMS at home was 80/52. Treated in ER with IV Benadryl, Demerol, and fluids on 9/27/14 at 3:30am. Discharged on 9/27/14 at 5:00am.
Age: 58.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site induration
Clinical narrative: Induration at site of injection measuring 3.5" x 1.5" in size to right deltoid.
Age: 51.0
Sex: F
Vaccine: FLU3
Symptoms: Injection site pain, Neck pain, Pain
Clinical narrative: Burning and pain at the site. I also had the pain shoot from my left deltoid up to the side of my left neck. I had to apply a cold rag for the burning.
Age: 3.0
Sex: F
Vaccine: FLU4
Symptoms: Injection site rash, Injection site reaction, Injection site swelling, Urticaria
Clinical narrative: Mom called and said that pt had a "welt" and rashy area at injection site. Approx. 1 cm "welt" not itchy. No fever. No resp. issues. Happy playful. Discussed with Dr. Advised mom to give 12.5 mg Benadryl.  If "welt" worsens or rash spreads call PCP to be seen. If respiratory issues or trouble swallowing go to ER. Called mom 9/30/14 pt had a good night. Rash is gone. Small raised area still on arm. Mom wondering now if it could even be a bug bite and not a reaction at all.
Age: 34.0
Sex: F
Vaccine: TDAP
Symptoms: Chills, Headache, Hypersomnia, Nausea, Pain
Clinical narrative: Fever 101 degrees. headache, chills, body aches and nausea. Used Ibuprofen and Tylenol. Slept all day on 9/27/14 and 9/28/14.
Age: 34.0
Sex: F
Vaccine: TDAP
Symptoms: Pyrexia
Clinical narrative: Fever 101 degrees. headache, chills, body aches and nausea. Used Ibuprofen and Tylenol. Slept all day on 9/27/14 and 9/28/14.
Age: 1.25
Sex: M
Vaccine: DTAP, HIBV, VARCEL
Symptoms: Crying, Decreased appetite, Irritability, Pyrexia, Sleep disorder
Clinical narrative: Fever of 102.7, followed by vomiting on 9/26, disturbed sleep, loss of appetite, irritability, inconsolable crying for several days.
Age: 1.25
Sex: M
Vaccine: DTAP, HIBV, VARCEL
Symptoms: Vomiting
Clinical narrative: Fever of 102.7, followed by vomiting on 9/26, disturbed sleep, loss of appetite, irritability, inconsolable crying for several days.
Age: 28.0
Sex: F
Vaccine: FLU3
Symptoms: Rash
Clinical narrative: Rash on arms and neck and chest.
Age: 73.0
Sex: F
Vaccine: FLU3
Symptoms: Chills, Fatigue, Headache, Nausea, Pain
Clinical narrative: Headache, nausea, body aches, fatigue, chills, fever.
Age: 73.0
Sex: F
Vaccine: FLU3
Symptoms: Pyrexia
Clinical narrative: Headache, nausea, body aches, fatigue, chills, fever.
Age: 79.0
Sex: F
Vaccine: FLU3
Symptoms: Immediate post-injection reaction, Injection site bruising, Injection site discolouration, Injection site pain
Clinical narrative: Patient woke up Sunday morning to find a bruised area on her right arm, slightly below site of injection. At time of presentation to pharmacy, area was ~4in long by ~3" wide. Color varied with top being more green/yellow and bottom of bruise purple/blue. Patient denied any pain or tender at site of bruise, but reported slight pain at time of injection.
Age: 5.0
Sex: M
Vaccine: DTAP, IPV
Symptoms: Injection site erythema, Injection site swelling, Pyrexia, Vomiting
Clinical narrative: Child has swelling and redness on Right deltoid where Dtap and IPV were administered. Mother states child has had low grade fever and vomiting. Temperature taken 98.6 degrees. Child taken to emergency department on 9/25/14.
Age: 25.0
Sex: M
Vaccine: ADEN_4_7, MNQ, TDAP
Symptoms: Hypoaesthesia, Intensive care, Musculoskeletal disorder, Nervous system disorder, Paraesthesia
Clinical narrative: Pt presented to Recruit Sick Call with c/o neuro deficits (numbness and tingling in fingers and toes) x 3 days. Pt examined and instructed to return for f/u next day. Pt returned with new c/o of difficulty controlling lower extremeties. Pt transferred to ER and then transferred to ICU where he remains at this time.