chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 18.0
Sex: F
Vaccine: FLU3
Symptoms: Syncope
Clinical narrative: Patient developed syncope after administration about 5 minutes after administration. Patient was coherent very quickly and was helped to floor by father and myself. Patient was placed on floor and then moved to chair. Thirty minutes later she walked out of store with no incident.
Age: 73.0
Sex: M
Vaccine: PNC13
Symptoms: Arthralgia, Musculoskeletal pain, Pain in extremity, X-ray normal
Clinical narrative: Patient awoke approximately a week after receiving the Prevnar 13 vaccine with initial wrist pain. He stated that over time the pain began to radiate up his arm to his shoulder. He sought medical treatment and was given an X-ray, with no musculoskeletal abnormalities found. Patient has since been prescribed a muscle relaxer (Metaxalone), opioid analgesic (Norco) and NSAID (Naproxen) to alleviate his pain.
Age: 51.0
Sex: F
Vaccine: FLU3, FLU3
Symptoms: Chest discomfort, Dizziness, Headache, Heart rate increased, Pain in extremity
Clinical narrative: Within minutes had tightness in chest, dizziness, HA, rapid pulse 11/05/15 dizziness/rapid pulse lasted 26 hours, upper arm swollen lasted 2 weeks, pain in arm lasted several weeks chest tight headache continued, round of prednisone then methyiprednisoXopenexlone helped some, Xopenex inhaler did not help, continued mild chest tightness.
Age: 51.0
Sex: F
Vaccine: FLU3, FLU3
Symptoms: Peripheral swelling
Clinical narrative: Within minutes had tightness in chest, dizziness, HA, rapid pulse 11/05/15 dizziness/rapid pulse lasted 26 hours, upper arm swollen lasted 2 weeks, pain in arm lasted several weeks chest tight headache continued, round of prednisone then methyiprednisoXopenexlone helped some, Xopenex inhaler did not help, continued mild chest tightness.
Age: 51.0
Sex: F
Vaccine: FLU3, FLU3
Symptoms: Dizziness, Dyspnoea, Headache, Heart rate increased, Injection site pain
Clinical narrative: Within minutes had tightness in chest, dizziness, HA, rapid pulse 11/05/15 dizziness/rapid pulse lasted 26 hours, upper arm swollen lasted 2 weeks, pain in arm lasted several weeks chest tight headache continued, round of prednisone then methyiprednisoXopenexlone helped some, Xopenex inhaler did not help, continued mild chest tightness.
Age: 51.0
Sex: F
Vaccine: FLU3, FLU3
Symptoms: Injection site swelling
Clinical narrative: Within minutes had tightness in chest, dizziness, HA, rapid pulse 11/05/15 dizziness/rapid pulse lasted 26 hours, upper arm swollen lasted 2 weeks, pain in arm lasted several weeks chest tight headache continued, round of prednisone then methyiprednisoXopenexlone helped some, Xopenex inhaler did not help, continued mild chest tightness.
Age: 62.0
Sex: M
Vaccine: FLU3
Symptoms: Complications of transplanted lung, Condition aggravated, Death, Lung transplant, Total lung capacity decreased
Clinical narrative: My father had interstitial lung disease for about 10 years at this point. He never received a flu shot before, & in the fall of 2009, there was widespread worry about swine flu.  Because of his condition, he decided it was prudent to get a flu shot.  Within 2 weeks of receiving the flu shot, his lung capacity went from 88% to 44% and he ended up in the hospital on oxygen.  His condition continued to downgrade until 1-1-10 when he received a lung transplant (he was in such need at that time, he was placed on the list and called for a transplant in less than a week).   I believe he would have died within a week or two of that time.  He did eventually die on May 16, 2010 due to complications of the lung transplant.
Age: 56.0
Sex: F
Vaccine: HEP, TDAP
Symptoms: Angina pectoris, Erythema, Fatigue, Feeling cold, Headache
Clinical narrative: At first I got Hepatitis B shot in the left arm, and as soon as I received the Tdap on the same arm I felt pain. I mean Just Tdap was painful when the needle went into the arm. Itching and skin rash and red skin both in the place of injection and other body parts like on the ankles and wrists. I also had pain in heart and bruise on the injection location. Followed by headache and feeling cold in whole body and chill. Extreme fatigue. After one week I went to see my doctor. She prescribed DiphenHydramine capsule 25 mg every 8 hours one capsule. After 3 days just itch is getting better but still I have some itching and headache.
Age: 56.0
Sex: F
Vaccine: HEP, TDAP
Symptoms: Injection site bruising, Injection site erythema, Injection site pain, Injection site pruritus, Injection site rash
Clinical narrative: At first I got Hepatitis B shot in the left arm, and as soon as I received the Tdap on the same arm I felt pain. I mean Just Tdap was painful when the needle went into the arm. Itching and skin rash and red skin both in the place of injection and other body parts like on the ankles and wrists. I also had pain in heart and bruise on the injection location. Followed by headache and feeling cold in whole body and chill. Extreme fatigue. After one week I went to see my doctor. She prescribed DiphenHydramine capsule 25 mg every 8 hours one capsule. After 3 days just itch is getting better but still I have some itching and headache.
Age: 56.0
Sex: F
Vaccine: HEP, TDAP
Symptoms: Pruritus, Rash
Clinical narrative: At first I got Hepatitis B shot in the left arm, and as soon as I received the Tdap on the same arm I felt pain. I mean Just Tdap was painful when the needle went into the arm. Itching and skin rash and red skin both in the place of injection and other body parts like on the ankles and wrists. I also had pain in heart and bruise on the injection location. Followed by headache and feeling cold in whole body and chill. Extreme fatigue. After one week I went to see my doctor. She prescribed DiphenHydramine capsule 25 mg every 8 hours one capsule. After 3 days just itch is getting better but still I have some itching and headache.
Age: 66.0
Sex: F
Vaccine: PNC13
Symptoms: Injection site erythema, Injection site inflammation, Injection site swelling
Clinical narrative: RED INFLAMED CIRCLE WITH SLIGHT ELEVATION ON THE SITE OF INJECTION. PATIENT WAS SEEN AT THE URGENT CARE CLINIC AND WAS GIVEN INJECTABLE DECADRON IM ON 1/24/16 PER HER DISCHARGE PAPER.
Age: 1.0
Sex: M
Vaccine: FLUX, HEPA, MMRV, PNC13, FLUX, HEPA, MMR, PNC13
Symptoms: Rash, Swelling face, Urticaria
Clinical narrative: Hives, swollen face (especially around eyes), scattered pimple-type bumps on body (arms, legs, and torso).
Age: 1.0
Sex: M
Vaccine: FLUX, HEPA, MMRV, PNC13, FLUX, HEPA, MMR, PNC13
Symptoms: Acne, Drug administered to patient of inappropriate age, Eye swelling, Rash, Swelling face
Clinical narrative: Hives, swollen face (especially around eyes), scattered pimple-type bumps on body (arms, legs, and torso).
Age: 1.0
Sex: M
Vaccine: FLUX, HEPA, MMRV, PNC13, FLUX, HEPA, MMR, PNC13
Symptoms: Urticaria
Clinical narrative: Hives, swollen face (especially around eyes), scattered pimple-type bumps on body (arms, legs, and torso).
Age: 0.17
Sex: M
Vaccine: DTAPHEPBIP, HIBV, RV1
Symptoms: Body temperature, Colitis, Colostomy, Diarrhoea, Emotional disorder
Clinical narrative: Inconsolable, diarrhea, temperature.
Age: 0.17
Sex: M
Vaccine: DTAPHEPBIP, HIBV, RV1
Symptoms: Ileostomy, Intestinal obstruction, Intestinal operation
Clinical narrative: Inconsolable, diarrhea, temperature.
Age: 3.0
Sex: M
Vaccine: FLU3
Symptoms: Pain, Peripheral swelling
Clinical narrative: Child informed mom that it was hurting him to walk.  Leg swelling.
Age: 1.07
Sex: F
Vaccine: HEPA, MMR, PPV, VARCEL
Symptoms: Cough, Fatigue, Injection site urticaria, Irritability, Pyrexia
Clinical narrative: Hives on face, Fatigue, Irritability, Fever (100.2) - Day 1. Extreme Hives all over body including sight of injection, cough, runny nose, low grade fever (99.3) - Day.
Age: 1.07
Sex: F
Vaccine: HEPA, MMR, PPV, VARCEL
Symptoms: Rhinorrhoea, Urticaria
Clinical narrative: Hives on face, Fatigue, Irritability, Fever (100.2) - Day 1. Extreme Hives all over body including sight of injection, cough, runny nose, low grade fever (99.3) - Day.
Age: 66.0
Sex: F
Vaccine: PPV
Symptoms: Erythema, Feeling hot, Peripheral swelling, Pruritus
Clinical narrative: Redness, swelling from shoulder to elbow. Hot and itchy.
Sex: U
Vaccine: HPV4
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: Information has been received from a healthcare worker (certified medical assistant) referring to multiple unspecified patients of unknown age and gender. The patients' medical history, concomitant therapy and drug reactions were not reported. The primary reporter reported that multiple unspecified patients were administered improperly stored GARDASIL (lot # K010215, expiry date 05-MAY-2017, lot # K007828, expiry date 02-MAR-2017) on multiple unspecified dates. The GARDASIL vaccines were exposed to -0.2 Celsius degree for 275 hours. These vaccines were administrated. There was no previous temperature excursion. No adverse effects were reported. Additional information has been requested.
Age: 14.0
Sex: M
Vaccine: VARCEL
Symptoms: Bone marrow transplant, CSF test, Polymerase chain reaction, Rash, Stem cell transplant
Clinical narrative: Information has been received from a pharmacist referring to a currently 14 year old male patient with Precursor B cell acute lymphocytic leukemia, meningitis, Graft Versus Host Disease and allergy to chlorhexidine and metoclopramide. On an unknown date the patient was vaccinated with a dose of VARIVAX (Merck) (dose, route and lot# were unknown) as a child (medication error). Concomitant therapies included sirolimus, calcium (unspecified), omega-3 marine triglycerides (reported as "fish oil"), budesonide, BACTRIM, lisinopril (manufacturer unknown), vitamin D (unspecified), multivitamins, MARINOL, tacrolimus and triamcinolone. On an unknown date, the patient had a bone marrow transplant and hospitalized. In February 2015, the patient had a cord blood stem cell transplant. On 18-DEC-2015 the patient developed a rash. He was hospitalized and treated with acyclovir intravenously since 24-DEC-2015. The reporter didn't know if the vaccine strain reactivated after the transplant. Lab tests including varicella zoster virus (VZV) polymerase chain reaction, VZV in cerebral spinal fluid and VZV in plasma were performed and the results were unavailable. At the time of reporting, the outcome of rash and bone marrow transplant was reported as recovering. The outcome of cord blood stem cell transplant was unknown. Causality was not provided. The reporter considered the events "rash" and "bone marrow transplant" as life threatening and also considered the event "rash" to be medically significant as acyclovir was given to prevent serious criteria. Additional information has been requested.
Age: 14.0
Sex: M
Vaccine: VARCEL
Symptoms: Varicella virus test
Clinical narrative: Information has been received from a pharmacist referring to a currently 14 year old male patient with Precursor B cell acute lymphocytic leukemia, meningitis, Graft Versus Host Disease and allergy to chlorhexidine and metoclopramide. On an unknown date the patient was vaccinated with a dose of VARIVAX (Merck) (dose, route and lot# were unknown) as a child (medication error). Concomitant therapies included sirolimus, calcium (unspecified), omega-3 marine triglycerides (reported as "fish oil"), budesonide, BACTRIM, lisinopril (manufacturer unknown), vitamin D (unspecified), multivitamins, MARINOL, tacrolimus and triamcinolone. On an unknown date, the patient had a bone marrow transplant and hospitalized. In February 2015, the patient had a cord blood stem cell transplant. On 18-DEC-2015 the patient developed a rash. He was hospitalized and treated with acyclovir intravenously since 24-DEC-2015. The reporter didn't know if the vaccine strain reactivated after the transplant. Lab tests including varicella zoster virus (VZV) polymerase chain reaction, VZV in cerebral spinal fluid and VZV in plasma were performed and the results were unavailable. At the time of reporting, the outcome of rash and bone marrow transplant was reported as recovering. The outcome of cord blood stem cell transplant was unknown. Causality was not provided. The reporter considered the events "rash" and "bone marrow transplant" as life threatening and also considered the event "rash" to be medically significant as acyclovir was given to prevent serious criteria. Additional information has been requested.
Age: 12.0
Sex: F
Vaccine: HPV4
Symptoms: Pyrexia
Clinical narrative: This spontaneous report was received from an epidemiologist who was also the patient's mother and refers to a 12 years old female patient with drug hypersensitivity (fever and nausea) following administration of unspecified vaccine (MARRS case 1601USA006994) and drug hypersensitivity (fever) following administration of MMR (manufacturer unknown) (MARRS case 1601USA006995). In November 2014, the patient was vaccinated with the first dose of GARDASIL (lot number, expiration date, dose and route of administration were not reported). In November 2015, the patient was vaccinated with the second dose of GARDASIL (lot number, expiration date, dose and route of administration were not reported). There was no concomitant medication reported. In approximately November 2015, reported as immediately following administration of the second dose, the patient experienced pyrexia (result and units were not reported). The patient did not seek medical attention and no product quality complain (PQC) was reported. At the reporting time, the outcome of pyrexia was recovered on an unspecified date. Additional information has been requested.
Sex: U
Vaccine: VARZOS
Symptoms: Drug administered to patient of inappropriate age, No adverse event
Clinical narrative: Information has been received from a pharmacist via a company representative referring to an unspecified number of patients (unknown demographics) under 50 years of age. Information about patients' concurrent conditions and medical history was not reported. On unspecified dates these patients received ZOSTAVAX (lot #, dose and route not reported) (inappropriate schedule of vaccine administered). No adverse effects were reported. Additional information has been requested.
Sex: U
Vaccine: MMR, VARCEL
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report was received from a registered nurse referring to an unspecified patient of unknown age and gender. Information about the patient's medical history and concurrent conditions was not provided. On 07-JAN-2016, the patient was vaccinated with improperly stored doses of (Oka/Merck) VARIVAX lot #: L032391, expiration date: 26-AUG-2017 and M-M-R II (lot # L007216, expiration date: 03-MAR-2017) (administration routes were not provided). No concomitant therapies were reported, neither was any adverse effect. It was unknown if the patient sought medical attention. No product quality complaint was involved. This is one of two reports from the same reporter. Additional information has been requested.
Age: 4.0
Sex: M
Vaccine: DTAP, IPV, MMRV
Symptoms: Expired product administered, No adverse event
Clinical narrative: This spontaneous report was received from a nurse via company representative refers to a 4 year old male patient. On 18-JAN-2016, the patient was vaccinated with an expired dose of PROQUAD (Merck) lot # K009473, expiry date 04-JAN-2016. No adverse effect was reported. The patient did not seek medical attention. Additional information has been requested.
Age: 0.5
Sex: U
Vaccine: MMRV
Symptoms: Drug administered to patient of inappropriate age, No adverse event
Clinical narrative: This spontaneous report as received from a healthcare professional refers to a 6 month old patient of unknown gender. Patient's concurrent condition and medical history was not known. On 01-OCT-2015 the patient was vaccinated with PROQUAD (Merck) dose 1. Concomitant medications were not provided. No adverse symptoms were reported. Product quality complaint was not filed. Additional information has been requested.
Age: 73.0
Sex: F
Vaccine: VARZOS, VARZOS
Symptoms: Blister, Herpes zoster, Rash
Clinical narrative: Information has been received from a physician assistant via a company representative and refers to a 73 year old female patient enrolled in a study. None pertinent medical history, drug reactions or allergies were reported. In approximately 2000, reported as "12 to 14 years ago", the patient was vaccinated with ZOSTAVAX (dose and lot# were not reported) as part of a "study". The reporter was not sure if the patient received ZOSTAVAX "unblinded". Concomitant therapy included unspecified cholesterol medication and unspecified hormone replacement. On 08-APR-2014, the patient experienced significant case of shingles with significant rash with grouped vesicles on the left flank to midline. On 11-APR-2014, the patient was seen at physician's office. The patient was prescribed VALTREX. The outcome of significant case of shingles was unknown. Causality was not reported. Follow up information has been received from the physician assistant and refers to the patient with hypertension, osteopenia, hyperlipidemia and atrophic vaginitis. Patient had no known drug allergy. Concomitant therapies included PREMARIN vaginal cream and ZOCOR. The Varicella Zoster Virus Identification Program (VZVIP) sample was obtained on 16-APR-2014. Type of adverse event of lesions was herpes zoster involved dermatome in T10 area. Patient did not have recent chickenpox or shingles vaccine. Follow-up information has been received from a healthcare professional. On 16-APR-2014, a specimen sample was obtained from the patient and sent to the Varicella Zoster Virus Identification Program (VZVIP). Three samples were obtained, the first one from a periumbilical vesicle/lesion, the second from a left side abdomen vesicle/lesion and the third from a left flank vesicle/lesion. The specimens arrived to laboratory on 17-APR-2014 and the varicella zoster virus (VZV) DNA was amplified. The final polymerase chain reaction (PCR) specimen results was wild type strain. On 10-JUN-2014, follow-up information has been received from a healthcare professional. The reporter stated that the patient had a history of chickenpox. The patient did not have a history of prior HZ. The reporter stated that the vaccination with ZOSTAVAX was not given by their office. 08-APR-2014 was the onset date of HZ (Herpes Zoster). There was no recent exposure to chickenpox or HZ. Dermatome(s) involved thoracic region TIO. There were many lesions and moreover on an unknown date in 2014, the patient developed post herpetic neuralgia (reported as still postherpetic neuralgia). The pain was at 8 (on a 0-10 scale where 0 is no pain and 10 is a maximum pain). The patient did not recover. There was a specimen collected for polymerase chain reaction (PCR) analysis. Result of PCR was unknown. It was reported that there were no other diagnostic tests performed. Additional information is not expected. This report was re-created from previously voided 1404USA007718.
Age: 73.0
Sex: F
Vaccine: VARZOS, VARZOS
Symptoms: Herpes zoster, Pain, Polymerase chain reaction positive, Post herpetic neuralgia, Rash vesicular
Clinical narrative: Information has been received from a physician assistant via a company representative and refers to a 73 year old female patient enrolled in a study. None pertinent medical history, drug reactions or allergies were reported. In approximately 2000, reported as "12 to 14 years ago", the patient was vaccinated with ZOSTAVAX (dose and lot# were not reported) as part of a "study". The reporter was not sure if the patient received ZOSTAVAX "unblinded". Concomitant therapy included unspecified cholesterol medication and unspecified hormone replacement. On 08-APR-2014, the patient experienced significant case of shingles with significant rash with grouped vesicles on the left flank to midline. On 11-APR-2014, the patient was seen at physician's office. The patient was prescribed VALTREX. The outcome of significant case of shingles was unknown. Causality was not reported. Follow up information has been received from the physician assistant and refers to the patient with hypertension, osteopenia, hyperlipidemia and atrophic vaginitis. Patient had no known drug allergy. Concomitant therapies included PREMARIN vaginal cream and ZOCOR. The Varicella Zoster Virus Identification Program (VZVIP) sample was obtained on 16-APR-2014. Type of adverse event of lesions was herpes zoster involved dermatome in T10 area. Patient did not have recent chickenpox or shingles vaccine. Follow-up information has been received from a healthcare professional. On 16-APR-2014, a specimen sample was obtained from the patient and sent to the Varicella Zoster Virus Identification Program (VZVIP). Three samples were obtained, the first one from a periumbilical vesicle/lesion, the second from a left side abdomen vesicle/lesion and the third from a left flank vesicle/lesion. The specimens arrived to laboratory on 17-APR-2014 and the varicella zoster virus (VZV) DNA was amplified. The final polymerase chain reaction (PCR) specimen results was wild type strain. On 10-JUN-2014, follow-up information has been received from a healthcare professional. The reporter stated that the patient had a history of chickenpox. The patient did not have a history of prior HZ. The reporter stated that the vaccination with ZOSTAVAX was not given by their office. 08-APR-2014 was the onset date of HZ (Herpes Zoster). There was no recent exposure to chickenpox or HZ. Dermatome(s) involved thoracic region TIO. There were many lesions and moreover on an unknown date in 2014, the patient developed post herpetic neuralgia (reported as still postherpetic neuralgia). The pain was at 8 (on a 0-10 scale where 0 is no pain and 10 is a maximum pain). The patient did not recover. There was a specimen collected for polymerase chain reaction (PCR) analysis. Result of PCR was unknown. It was reported that there were no other diagnostic tests performed. Additional information is not expected. This report was re-created from previously voided 1404USA007718.
Age: 73.0
Sex: F
Vaccine: VARZOS, VARZOS
Symptoms: Skin lesion
Clinical narrative: Information has been received from a physician assistant via a company representative and refers to a 73 year old female patient enrolled in a study. None pertinent medical history, drug reactions or allergies were reported. In approximately 2000, reported as "12 to 14 years ago", the patient was vaccinated with ZOSTAVAX (dose and lot# were not reported) as part of a "study". The reporter was not sure if the patient received ZOSTAVAX "unblinded". Concomitant therapy included unspecified cholesterol medication and unspecified hormone replacement. On 08-APR-2014, the patient experienced significant case of shingles with significant rash with grouped vesicles on the left flank to midline. On 11-APR-2014, the patient was seen at physician's office. The patient was prescribed VALTREX. The outcome of significant case of shingles was unknown. Causality was not reported. Follow up information has been received from the physician assistant and refers to the patient with hypertension, osteopenia, hyperlipidemia and atrophic vaginitis. Patient had no known drug allergy. Concomitant therapies included PREMARIN vaginal cream and ZOCOR. The Varicella Zoster Virus Identification Program (VZVIP) sample was obtained on 16-APR-2014. Type of adverse event of lesions was herpes zoster involved dermatome in T10 area. Patient did not have recent chickenpox or shingles vaccine. Follow-up information has been received from a healthcare professional. On 16-APR-2014, a specimen sample was obtained from the patient and sent to the Varicella Zoster Virus Identification Program (VZVIP). Three samples were obtained, the first one from a periumbilical vesicle/lesion, the second from a left side abdomen vesicle/lesion and the third from a left flank vesicle/lesion. The specimens arrived to laboratory on 17-APR-2014 and the varicella zoster virus (VZV) DNA was amplified. The final polymerase chain reaction (PCR) specimen results was wild type strain. On 10-JUN-2014, follow-up information has been received from a healthcare professional. The reporter stated that the patient had a history of chickenpox. The patient did not have a history of prior HZ. The reporter stated that the vaccination with ZOSTAVAX was not given by their office. 08-APR-2014 was the onset date of HZ (Herpes Zoster). There was no recent exposure to chickenpox or HZ. Dermatome(s) involved thoracic region TIO. There were many lesions and moreover on an unknown date in 2014, the patient developed post herpetic neuralgia (reported as still postherpetic neuralgia). The pain was at 8 (on a 0-10 scale where 0 is no pain and 10 is a maximum pain). The patient did not recover. There was a specimen collected for polymerase chain reaction (PCR) analysis. Result of PCR was unknown. It was reported that there were no other diagnostic tests performed. Additional information is not expected. This report was re-created from previously voided 1404USA007718.
Age: 56.0
Sex: F
Vaccine: PPV
Symptoms: Erythema, Induration, Peripheral swelling
Clinical narrative: Swollen, red, indurated arm.
Age: 15.0
Sex: F
Vaccine: HPV4, HPV4
Symptoms: Amenorrhoea, Blood thyroid stimulating hormone normal, Differential white blood cell count normal, Full blood count normal, Headache
Clinical narrative: Information has been received from a consumer referring to her 15 year old daughter. The patient had penicillin allergy and a history of headaches off and on. On 28-AUG-2015 at 09:30 the patient was vaccinated with the first dose of GARDASIL (lot # K010215, intramuscularly in the right deltoid, dose and expiration date were unknown). Basic metabolic panel, full blood count (CBC) with differential and platelets, lipid panel, blood thyroid stimulating hormone (TSH) and vitamin D level on that day were normal. The patient had no illness at the time of vaccination. Concomitant therapies included ZYRTEC. On 29-SEP-2015, the patient missed a whole month of menstrual period, which started again (menstrual cycle) on 28-OCT-2015. The patient had never missed period prior to GARDASIL. On 02-NOV-2015 at 15:20 the patient was vaccinated with the second dose of GARDASIL (lot # K010215, intramuscularly in the right deltoid, dose and expiration date were unknown). On 04-NOV-2015 (2 days after the second dose of GARDASIL, the patient got headache. Headache was continuous for 7 days (ended on 11-NOV-2015). The patient had menstrual period on 30-NOV-2015 as well. The mother of the patient was stated that the first shot affected menstrual cycle but the second shot did not. The patient had a history of headaches off and on but none had lasted as long as 7 days. The patient did not require emergency room or doctor visit. Additional information has been requested.
Age: 15.0
Sex: F
Vaccine: HPV4, HPV4
Symptoms: Lipids normal, Metabolic function test normal, Vitamin D
Clinical narrative: Information has been received from a consumer referring to her 15 year old daughter. The patient had penicillin allergy and a history of headaches off and on. On 28-AUG-2015 at 09:30 the patient was vaccinated with the first dose of GARDASIL (lot # K010215, intramuscularly in the right deltoid, dose and expiration date were unknown). Basic metabolic panel, full blood count (CBC) with differential and platelets, lipid panel, blood thyroid stimulating hormone (TSH) and vitamin D level on that day were normal. The patient had no illness at the time of vaccination. Concomitant therapies included ZYRTEC. On 29-SEP-2015, the patient missed a whole month of menstrual period, which started again (menstrual cycle) on 28-OCT-2015. The patient had never missed period prior to GARDASIL. On 02-NOV-2015 at 15:20 the patient was vaccinated with the second dose of GARDASIL (lot # K010215, intramuscularly in the right deltoid, dose and expiration date were unknown). On 04-NOV-2015 (2 days after the second dose of GARDASIL, the patient got headache. Headache was continuous for 7 days (ended on 11-NOV-2015). The patient had menstrual period on 30-NOV-2015 as well. The mother of the patient was stated that the first shot affected menstrual cycle but the second shot did not. The patient had a history of headaches off and on but none had lasted as long as 7 days. The patient did not require emergency room or doctor visit. Additional information has been requested.
Age: 15.0
Sex: F
Vaccine: HPV4, HPV4
Symptoms: Blood thyroid stimulating hormone normal, Differential white blood cell count normal, Full blood count normal, Headache, Lipids normal
Clinical narrative: Information has been received from a consumer referring to her 15 year old daughter. The patient had penicillin allergy and a history of headaches off and on. On 28-AUG-2015 at 09:30 the patient was vaccinated with the first dose of GARDASIL (lot # K010215, intramuscularly in the right deltoid, dose and expiration date were unknown). Basic metabolic panel, full blood count (CBC) with differential and platelets, lipid panel, blood thyroid stimulating hormone (TSH) and vitamin D level on that day were normal. The patient had no illness at the time of vaccination. Concomitant therapies included ZYRTEC. On 29-SEP-2015, the patient missed a whole month of menstrual period, which started again (menstrual cycle) on 28-OCT-2015. The patient had never missed period prior to GARDASIL. On 02-NOV-2015 at 15:20 the patient was vaccinated with the second dose of GARDASIL (lot # K010215, intramuscularly in the right deltoid, dose and expiration date were unknown). On 04-NOV-2015 (2 days after the second dose of GARDASIL, the patient got headache. Headache was continuous for 7 days (ended on 11-NOV-2015). The patient had menstrual period on 30-NOV-2015 as well. The mother of the patient was stated that the first shot affected menstrual cycle but the second shot did not. The patient had a history of headaches off and on but none had lasted as long as 7 days. The patient did not require emergency room or doctor visit. Additional information has been requested.
Age: 15.0
Sex: F
Vaccine: HPV4, HPV4
Symptoms: Menstruation delayed, Metabolic function test normal, Vitamin D
Clinical narrative: Information has been received from a consumer referring to her 15 year old daughter. The patient had penicillin allergy and a history of headaches off and on. On 28-AUG-2015 at 09:30 the patient was vaccinated with the first dose of GARDASIL (lot # K010215, intramuscularly in the right deltoid, dose and expiration date were unknown). Basic metabolic panel, full blood count (CBC) with differential and platelets, lipid panel, blood thyroid stimulating hormone (TSH) and vitamin D level on that day were normal. The patient had no illness at the time of vaccination. Concomitant therapies included ZYRTEC. On 29-SEP-2015, the patient missed a whole month of menstrual period, which started again (menstrual cycle) on 28-OCT-2015. The patient had never missed period prior to GARDASIL. On 02-NOV-2015 at 15:20 the patient was vaccinated with the second dose of GARDASIL (lot # K010215, intramuscularly in the right deltoid, dose and expiration date were unknown). On 04-NOV-2015 (2 days after the second dose of GARDASIL, the patient got headache. Headache was continuous for 7 days (ended on 11-NOV-2015). The patient had menstrual period on 30-NOV-2015 as well. The mother of the patient was stated that the first shot affected menstrual cycle but the second shot did not. The patient had a history of headaches off and on but none had lasted as long as 7 days. The patient did not require emergency room or doctor visit. Additional information has been requested.
Age: 0.88
Sex: F
Vaccine: DTAPHEPBIP, HIBV, PNC13
Symptoms: Amblyopia
Clinical narrative: Parent states that pt started having lazy eye Left side the next day.
Age: 0.8
Sex: U
Vaccine: HEP
Symptoms: Accidental overdose, No adverse event
Clinical narrative: This spontaneous report as received from a registered nurse refers to a 9 month old patient of unknown gender. Concurrent conditions and medical history were not reported. On unknown dates, the patients was vaccinated with the first and second dose of RECOMBIVAX HB (Lot number, expiration date, route and dose were not provided). On 14-OCT-2015, the patient was inadvertently vaccinated with an adult dose as the third dose of RECOMBIVAX HB 10 microgram (lot number, expiration date, route and dose were not provided). Concomitant medication was not reported. The nurse stated that there was no product confusion involved. No adverse symptoms reported. Additional information is not expected.
Sex: U
Vaccine: VARZOS
Symptoms: Extra dose administered, No adverse event
Clinical narrative: Information has been received from a nurse referring to a patient of unknown age and gender. On 29-SEP-2015, the patient received a dose of ZOSTAVAX (unspecified Lot#, exp. Date and dose), and then on 19-JAN-2016 the patient was vaccinated with another dose of ZOSTAVAX (lot # L024997, dose, expiration data were not reported), which was outside the recommended per the ZOSTAVAX prescribing information. No adverse effects were reported. Additional information has been requested.
Sex: F
Vaccine: VARZOS
Symptoms: Injection site reaction, Rash pruritic
Clinical narrative: This spontaneous report has been received from a pharmacist referring to a female patient in her 60's with allergic to morphine. On 18-JAN-2016 the patient was vaccinated with a dose of 0.65 ml ZOSTAVAX (route and lot# not reported) in the left upper arm. Concomitant therapy was not reported. It was reported that on 20-JAN-2016 (reported as "now") the patient had raised, itchy b umps at the injection site. No other symptoms reported. The patient sought medical attention by calling pharmacist. The outcome of the events was reported as not recovered/not resolved. The causality was not reported. Additional information has been requested.
Sex: U
Vaccine: HEP
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: Information has been received from a Certified Medical Assistant (CMA) referring to a patient of unknown age and gender. The patient's concurrent and historical conditions were not reported. On an unknown date the patient was vaccinated with one dose of improperly stored (at 33.26F for 27 hours) RECOMBIVAX HB (lot # L044707, expiration date 06-OCT-2018, strength, dose and route were unknown). There was no temperature excursion issues previously. Concomitant therapies were not reported. No adverse effects were reported. Additional information has been requested.
Sex: U
Vaccine: VARCEL
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report has been received from a physician referring to unspecified number of patients of unknown age and gender. On unknown dates the patients were vaccinated with VARIVAX (Merck) (Lot#L034372 and expiration date of 08-SEP-2017, Lot#L023594 and expiration date of 26-JUN-2017, Lot#L029472 and expiration date of 06-AUG-2017) that were improperly stored (Incorrect product storage). No adverse effects reported. Additional information is not expected as there is no consent for follow up.
Sex: U
Vaccine: VARZOS
Symptoms: Injection site erythema
Clinical narrative: Information has been received from a pharmacist via a field employee referring to multiple unspecified patients of unknown age and gender. The patients' pertinent medical history, drug reactions and concomitant medications were not specified. On unknown dates the patients were vaccinated with ZOSTAVAX (lot number, expired date, dose and route unknown). On unknown dates the patients experienced a red spot at the injection site after administering ZOSTAVAX. The outcome of the event and causality with ZOSTAVAX were not provided. It was not reported if the patients sought any medical attention and there was no product quality compliant (PQC). Additional information has been requested.
Sex: F
Vaccine: HPV4
Symptoms: Lyme disease, Migraine, Postural orthostatic tachycardia syndrome
Clinical narrative: This spontaneous report was retrieved from webpage Sanevax, Inc. where the patient's mother reported on her daughter, a female patient of unknown age. No information regarding the patient's medical history, concurrent conditions and concomitant medications was reported. In approximately February 2014, the patient was vaccinated with a dose of GARDASIL, (dose, route of administration, lot number and expiration date were not reported). On an unknown date in approximately 2014, the patient experienced Lyme disease and chops migraine pathway for which she was treated with unspecified medications. It was reported that the patient was supposed to see a specialist for postural orthostatic tachycardia syndrome (POTS) in October. The outcome of the events was unknown at the time of the report. The relatedness between the events was unknown at the time of the report. The relatedness between the events and GARDASIL was not provided. This is one of several reports received from the same reporter. Additional information has been requested.
Age: 69.0
Sex: F
Vaccine: PNC13
Symptoms: Injection site erythema, Injection site pruritus, Injection site swelling, Rash generalised
Clinical narrative: Redness, itching, swelling at injection site, progressing to full body rash. MD prescribed MEDROL dose pack w/ZYRTEC.
Age: 69.0
Sex: M
Vaccine: FLU3, PPV, FLU3, PPV
Symptoms: Erythema, Injection site erythema, Injection site pruritus, Injection site swelling, Injection site warmth
Clinical narrative: Symptoms include erythema, swelling with itching, and warmth on left upper and lower extremity. Treated with BENADRYL every 4 hours as needed.
Age: 69.0
Sex: M
Vaccine: FLU3, PPV, FLU3, PPV
Symptoms: Peripheral swelling, Pruritus, Skin warm
Clinical narrative: Symptoms include erythema, swelling with itching, and warmth on left upper and lower extremity. Treated with BENADRYL every 4 hours as needed.
Age: 14.0
Sex: F
Vaccine: FLU4, PPV, FLU3, PPV
Symptoms: Fatigue, Generalised oedema, Headache, Influenza virus test negative, Injection site erythema
Clinical narrative: Rash, red, generalized, raised and swollen at injection site with generalized edema. Symptoms began 2 days after injection. Fever, muscle pain, nausea, headache and fatigue.
Age: 14.0
Sex: F
Vaccine: FLU4, PPV, FLU3, PPV
Symptoms: Injection site rash, Injection site swelling, Myalgia, Nausea, Pyrexia
Clinical narrative: Rash, red, generalized, raised and swollen at injection site with generalized edema. Symptoms began 2 days after injection. Fever, muscle pain, nausea, headache and fatigue.
Age: 14.0
Sex: F
Vaccine: FLU4, PPV, FLU3, PPV
Symptoms: Fatigue, Generalised erythema, Generalised oedema, Headache, Influenza virus test negative
Clinical narrative: Rash, red, generalized, raised and swollen at injection site with generalized edema. Symptoms began 2 days after injection. Fever, muscle pain, nausea, headache and fatigue.
Age: 14.0
Sex: F
Vaccine: FLU4, PPV, FLU3, PPV
Symptoms: Injection site swelling, Myalgia, Nausea, Pyrexia, Rash generalised
Clinical narrative: Rash, red, generalized, raised and swollen at injection site with generalized edema. Symptoms began 2 days after injection. Fever, muscle pain, nausea, headache and fatigue.
Age: 11.0
Sex: F
Vaccine: HPV4, HPV4
Symptoms: Musculoskeletal stiffness, Syncope, Tonic clonic movements
Clinical narrative: This spontaneous report as received from a physician via a company representative refers to a 11 year old non-pregnant female patient. The patient's pertinent medical history, concomitant medications and drug reactions or allergies were not reported. On 20-JAN-2016, the patient was vaccinated with a dose of (reported as "1 shot") of GARDASIL (lot # K010215, expiry date May 2017, dose and anatomical location not reported, intramuscularly). On 20-JAN-2016, within a minute or two of receiving the dose of GARDASIL, the patient had syncope. After recovering from fainting, she experienced tonic-clonic movement with generalized stiffness in her muscles. No treatment was given for the symptoms, they just held her for a period of observation and gave her juice. The patient fully recovered. It was reported that the patient sought medical attention and that vaccination with GARDASIL was not reintroduced. The outcome of syncope and tonic-clonic movement with generalized stiffness in muscles was recovered (on 20-JAN-2016). The relatedness between the adverse events and GARDASIL was not provided. Additional information has been requested.
Age: 11.0
Sex: F
Vaccine: HPV4, HPV4
Symptoms: Back pain, Immediate post-injection reaction, Loss of consciousness, Musculoskeletal stiffness, Neck pain
Clinical narrative: This spontaneous report as received from a physician via a company representative refers to a 11 year old non-pregnant female patient. The patient's pertinent medical history, concomitant medications and drug reactions or allergies were not reported. On 20-JAN-2016, the patient was vaccinated with a dose of (reported as "1 shot") of GARDASIL (lot # K010215, expiry date May 2017, dose and anatomical location not reported, intramuscularly). On 20-JAN-2016, within a minute or two of receiving the dose of GARDASIL, the patient had syncope. After recovering from fainting, she experienced tonic-clonic movement with generalized stiffness in her muscles. No treatment was given for the symptoms, they just held her for a period of observation and gave her juice. The patient fully recovered. It was reported that the patient sought medical attention and that vaccination with GARDASIL was not reintroduced. The outcome of syncope and tonic-clonic movement with generalized stiffness in muscles was recovered (on 20-JAN-2016). The relatedness between the adverse events and GARDASIL was not provided. Additional information has been requested.
Age: 11.0
Sex: F
Vaccine: HPV4, HPV4
Symptoms: Opisthotonus, Syncope, Tonic clonic movements, Tremor, Unresponsive to stimuli
Clinical narrative: This spontaneous report as received from a physician via a company representative refers to a 11 year old non-pregnant female patient. The patient's pertinent medical history, concomitant medications and drug reactions or allergies were not reported. On 20-JAN-2016, the patient was vaccinated with a dose of (reported as "1 shot") of GARDASIL (lot # K010215, expiry date May 2017, dose and anatomical location not reported, intramuscularly). On 20-JAN-2016, within a minute or two of receiving the dose of GARDASIL, the patient had syncope. After recovering from fainting, she experienced tonic-clonic movement with generalized stiffness in her muscles. No treatment was given for the symptoms, they just held her for a period of observation and gave her juice. The patient fully recovered. It was reported that the patient sought medical attention and that vaccination with GARDASIL was not reintroduced. The outcome of syncope and tonic-clonic movement with generalized stiffness in muscles was recovered (on 20-JAN-2016). The relatedness between the adverse events and GARDASIL was not provided. Additional information has been requested.
Age: 15.0
Sex: F
Vaccine: HPV9
Symptoms: Injection site nodule, Injection site pain, Paraesthesia
Clinical narrative: This spontaneous report as received from a physician via a company representative refers to a 15 year old female patient. There was no information about the patient's concomitant medications, drug reactions/allergies and pertinent medical history reported. On an unknown date, the patient was vaccinated with the first GARDASIL 9 (dose, strength, route, lot# and expiry date were not reported). On an unknown date (also reported as "after receiving the GARDASIL 9)"), the patient experienced a knot on her arm. The knot went away after one week on an unknown date. On an unknown date, the patient was vaccinated with the second dose of GARDASIL 9 dose: 0.5 ml, intramuscularly in the arm (strength, lot# and expiry date were not reported) for protecting patient against HPV and cancers. On an unknown date, the patient experienced a "knot" around the injection site on her arm and the "knot" was still appearing on her arm "3 weeks" after being vaccinated. The "knot" was similar to the "knot" which the patient experienced after first dose of GARDASIL 9. The "knot" on her arm was tender to the touch and she had a "tingling" sensation down her arm as well. No treatment was given for the events. The outcome of the events was unknown. The patient sought the medical attention by calling the doctor. The relatedness between the events and GARDASIL 9 was not reported. Additional information is not expected as the physician did not want tot be contacted regarding this adverse events.
Age: 12.0
Sex: U
Vaccine: HPV4
Symptoms: Activities of daily living impaired, Malaise, Pain
Clinical narrative: This spontaneous report as retrieved from webpage refers to a 12 year old patient of unknown gender who was reporting on themselves. No information regarding the patient's medical history, concurrent conditions and concomitant medications was reported. On an unknown date in 2011, the patient was vaccinated with a dose of GARDASIL, (dose, route of administration, lot number and expiration date were not reported). On an unknown date in approximately 2011, the patient experienced indescribable pain. It was also reported that it was a desperate and terrible time for the patient because they were unable to do anything, being blamed for being sick and no help was in sight. According to the reporter, 6 months into their sickness, they went to a homeopathic doctor (natural medicine) and were given unspecified remedies which slowly cured them (date unspecified). The relatedness between the events and GARDASIL was not reported. This is one of several reports received from the same reporter. Additional information has been requested.
Sex: F
Vaccine: HPV4
Symptoms: Infection, Lyme disease, Refusal of treatment by patient, Wheelchair user
Clinical narrative: This spontaneous social media report was received from a patient's parent via web page and refers to a female patient of unknown age. The patient's medical history and current conditions were not provided. On an unknown date, the patient was vaccinated with a dose of GARDASIL (lot #, expiration date, dose and route of administration were not reported). Secondary suspects and concomitant therapies were not reported. On an unknown date, the patient was diagnosed with co-infector and Lyme illiterate state. The patient was refused a standard anti-biotic treatment. There was some "permed ant damage" from going years without treatment. The patient underwent alternative, non-invasive treatment. The outcome of adverse events was reported as drastic improvement as the patient went from asking for a wheelchair to applying to college within days. The relatedness between adverse events and GARDASIL was not reported. Upon internal review, the events were considered to be disabling as the reporter stated that they caused permanent damage. This is one of several reports received from the same source. Additional information has been requested.
Sex: U
Vaccine: HIBV
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report as received from a nurse refers to multiple unspecified patients of unknown age and gender. No medical history and concurrent conditions were reported. On an unknown date the patients were vaccinated with improperly stored LIQUID PEDVAXHIB (lot # L030869, expiry date 08-JUN-2018) (dosing regimen and frequency unknown) for an unknown indication. No concomitant medications were reported. No adverse effects were reported. The action taken with the therapy with LIQUID PEDVAXHIB was unknown. There was no product quality complaint reported. It was reported that the vaccines were exposed to a temperature of 32.4 degrees farenheit a cumulative total of 13 hours. This is one of the 3 reports from the same source. Additional information has been requested.