chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 64.0
Sex: F
Vaccine: PNC13, PNC13
Symptoms: Dyspnoea, Gait disturbance, Herpes zoster, Injection site bruising, Injection site pain
Clinical narrative: I received an vaccination (Pneumococcal #13) injection in the Pulmonary Department of Hospital. I was referred to this department by Dr. to further check my lungs. The doctor stated that my lungs looked fair to him. I was about to leave when he read into his computer and I stated that I needed a Pneumococcal vaccination #13 to fight against the pneumonia disease. I agreed, then he stated that he was going to get a nurse; so I waited approximately 30 minutes and began feeling impatient. The nurse finally showed up with a good size tube of injection medicine and requested that I stand very still because this tube of medicine will be long and slow. The nurses bedside mannerism was strange and not too comforting. I should have walked but the feared a written report against me. The same night, that medicine or whatever she unloaded into my left arm, below my shoulder, was giving my arm spasms, long agonizing and excruciating pains in my biceps for 6 months without movement. It took that medicine (which felt like a tube of oil and peanut butter) months to move one inch. It took over a minute for her to unload the medicine from the needle into my left arm so it could travel throughout my entire body. The same night of that injection, I was fighting for the comfort my life. I had to use my bed railings to strengthen and comfort my arm. I could barely breathe or sleep for days. My arm muscle was going through turmoils of excruciating (it felt like a nerve agent or a debilitating agent) pains and next blisters and bruisings appeared on my biceps. I called insurance and the nurse told me to go to the emergency room; I was ill treated and discriminated against by Drs. Dr. called it Shingles. Dr. treated me like a crackhead because I was in so much agonizing pain and was about to throw me out until I mentioned that I have a Masters degree in Emergency Management and that I did not appreciate how he was handling the situation. Shame for around 10 seconds befail him so he then started to pretend as if he cared by requesting testing orders to be carried out and he brushed Dr. off and sent her away. The injection has traveled throughout my whole body and has given me other diseases, aching arms muscles and legs calves. My bones in both arms and my leg aches. My legs calves muscles aches and feel debilitating and stiff. My legs calves muscles are hardening inside which makes it painful and strenuous for me to walk. Daily sharp pains and throbbings are now in both of my arms biceps which throbs and aches and radiates down both arms. My bones ACHES and I DO NOT WANT TO TAKE THOSE KILLER PAIN PILLS. I struggle daily because what was in that injection has complicated my life. I was working on getting rid of all medicines but now I have to take more. I now have a painful tumor or growth in the left bottom backside of my skull.
Age: 64.0
Sex: F
Vaccine: PNC13, PNC13
Symptoms: Injection site vesicles, Insomnia, Laboratory test, Muscle spasms, Musculoskeletal stiffness
Clinical narrative: I received an vaccination (Pneumococcal #13) injection in the Pulmonary Department of Hospital. I was referred to this department by Dr. to further check my lungs. The doctor stated that my lungs looked fair to him. I was about to leave when he read into his computer and I stated that I needed a Pneumococcal vaccination #13 to fight against the pneumonia disease. I agreed, then he stated that he was going to get a nurse; so I waited approximately 30 minutes and began feeling impatient. The nurse finally showed up with a good size tube of injection medicine and requested that I stand very still because this tube of medicine will be long and slow. The nurses bedside mannerism was strange and not too comforting. I should have walked but the feared a written report against me. The same night, that medicine or whatever she unloaded into my left arm, below my shoulder, was giving my arm spasms, long agonizing and excruciating pains in my biceps for 6 months without movement. It took that medicine (which felt like a tube of oil and peanut butter) months to move one inch. It took over a minute for her to unload the medicine from the needle into my left arm so it could travel throughout my entire body. The same night of that injection, I was fighting for the comfort my life. I had to use my bed railings to strengthen and comfort my arm. I could barely breathe or sleep for days. My arm muscle was going through turmoils of excruciating (it felt like a nerve agent or a debilitating agent) pains and next blisters and bruisings appeared on my biceps. I called insurance and the nurse told me to go to the emergency room; I was ill treated and discriminated against by Drs. Dr. called it Shingles. Dr. treated me like a crackhead because I was in so much agonizing pain and was about to throw me out until I mentioned that I have a Masters degree in Emergency Management and that I did not appreciate how he was handling the situation. Shame for around 10 seconds befail him so he then started to pretend as if he cared by requesting testing orders to be carried out and he brushed Dr. off and sent her away. The injection has traveled throughout my whole body and has given me other diseases, aching arms muscles and legs calves. My bones in both arms and my leg aches. My legs calves muscles aches and feel debilitating and stiff. My legs calves muscles are hardening inside which makes it painful and strenuous for me to walk. Daily sharp pains and throbbings are now in both of my arms biceps which throbs and aches and radiates down both arms. My bones ACHES and I DO NOT WANT TO TAKE THOSE KILLER PAIN PILLS. I struggle daily because what was in that injection has complicated my life. I was working on getting rid of all medicines but now I have to take more. I now have a painful tumor or growth in the left bottom backside of my skull.
Age: 64.0
Sex: F
Vaccine: PNC13, PNC13
Symptoms: Myalgia, Myosclerosis, Pain, Pain in extremity
Clinical narrative: I received an vaccination (Pneumococcal #13) injection in the Pulmonary Department of Hospital. I was referred to this department by Dr. to further check my lungs. The doctor stated that my lungs looked fair to him. I was about to leave when he read into his computer and I stated that I needed a Pneumococcal vaccination #13 to fight against the pneumonia disease. I agreed, then he stated that he was going to get a nurse; so I waited approximately 30 minutes and began feeling impatient. The nurse finally showed up with a good size tube of injection medicine and requested that I stand very still because this tube of medicine will be long and slow. The nurses bedside mannerism was strange and not too comforting. I should have walked but the feared a written report against me. The same night, that medicine or whatever she unloaded into my left arm, below my shoulder, was giving my arm spasms, long agonizing and excruciating pains in my biceps for 6 months without movement. It took that medicine (which felt like a tube of oil and peanut butter) months to move one inch. It took over a minute for her to unload the medicine from the needle into my left arm so it could travel throughout my entire body. The same night of that injection, I was fighting for the comfort my life. I had to use my bed railings to strengthen and comfort my arm. I could barely breathe or sleep for days. My arm muscle was going through turmoils of excruciating (it felt like a nerve agent or a debilitating agent) pains and next blisters and bruisings appeared on my biceps. I called insurance and the nurse told me to go to the emergency room; I was ill treated and discriminated against by Drs. Dr. called it Shingles. Dr. treated me like a crackhead because I was in so much agonizing pain and was about to throw me out until I mentioned that I have a Masters degree in Emergency Management and that I did not appreciate how he was handling the situation. Shame for around 10 seconds befail him so he then started to pretend as if he cared by requesting testing orders to be carried out and he brushed Dr. off and sent her away. The injection has traveled throughout my whole body and has given me other diseases, aching arms muscles and legs calves. My bones in both arms and my leg aches. My legs calves muscles aches and feel debilitating and stiff. My legs calves muscles are hardening inside which makes it painful and strenuous for me to walk. Daily sharp pains and throbbings are now in both of my arms biceps which throbs and aches and radiates down both arms. My bones ACHES and I DO NOT WANT TO TAKE THOSE KILLER PAIN PILLS. I struggle daily because what was in that injection has complicated my life. I was working on getting rid of all medicines but now I have to take more. I now have a painful tumor or growth in the left bottom backside of my skull.
Age: 68.0
Sex: M
Vaccine: VARZOS, VARZOS
Symptoms: Fatigue, Rash
Clinical narrative: This case was reported by a consumer via call center representative and described the occurrence of fatigue in a 68-year-old male patient who received SHINGRIX for prophylaxis. Co-suspect products included Influenza vaccine Quadrivalent unspecified season for prophylaxis. Previously administered products included ZOSTAVAX (administered a few years before the date of reporting). Concurrent medical conditions included prostate cancer (low grade), glucose tolerance impaired, venous stasis ulcer and blood pressure high (controlled). Concomitant products included folic acid, Metformin, simvastatin, bumetanide, clonidine, hydralazine and metoprolol. On 3rd May 2018 12:00, the patient received the 1st dose of SHINGRIX. On an unknown date, the patient received Influenza vaccine Quadrivalent unspecified season at an unknown dose. In June 2018, 21 days after receiving SHINGRIX and less than a year after receiving Influenza vaccine Quadrivalent unspecified season, the patient experienced fatigue, rash and red blotches. On an unknown date, the outcome of the fatigue was recovering/resolving and the outcome of the rash and red blotches were not recovered/not resolved. The reporter considered the fatigue, rash and red blotches to be possibly related to SHINGRIX. It was unknown if the reporter considered the fatigue, rash and red blotches to be related to Influenza vaccine Quadrivalent unspecified season. Additional information was reported as follows: The patient also had a flu vaccine which was administered, for more than 4 weeks prior to the SHINGRIX. The rash and fatigue presented 3 to 4 weeks following the vaccination. The rash started to present across the upper chest, below the neck. It spread from one side to the other and then to both upper arms above the elbows. The rash was pink blotches that look similar to chicken pox bumps.
Age: 68.0
Sex: M
Vaccine: VARZOS, VARZOS
Symptoms: Fatigue, Rash, Rash macular, Rash vesicular
Clinical narrative: This case was reported by a consumer via call center representative and described the occurrence of fatigue in a 68-year-old male patient who received SHINGRIX for prophylaxis. Co-suspect products included Influenza vaccine Quadrivalent unspecified season for prophylaxis. Previously administered products included ZOSTAVAX (administered a few years before the date of reporting). Concurrent medical conditions included prostate cancer (low grade), glucose tolerance impaired, venous stasis ulcer and blood pressure high (controlled). Concomitant products included folic acid, Metformin, simvastatin, bumetanide, clonidine, hydralazine and metoprolol. On 3rd May 2018 12:00, the patient received the 1st dose of SHINGRIX. On an unknown date, the patient received Influenza vaccine Quadrivalent unspecified season at an unknown dose. In June 2018, 21 days after receiving SHINGRIX and less than a year after receiving Influenza vaccine Quadrivalent unspecified season, the patient experienced fatigue, rash and red blotches. On an unknown date, the outcome of the fatigue was recovering/resolving and the outcome of the rash and red blotches were not recovered/not resolved. The reporter considered the fatigue, rash and red blotches to be possibly related to SHINGRIX. It was unknown if the reporter considered the fatigue, rash and red blotches to be related to Influenza vaccine Quadrivalent unspecified season. Additional information was reported as follows: The patient also had a flu vaccine which was administered, for more than 4 weeks prior to the SHINGRIX. The rash and fatigue presented 3 to 4 weeks following the vaccination. The rash started to present across the upper chest, below the neck. It spread from one side to the other and then to both upper arms above the elbows. The rash was pink blotches that look similar to chicken pox bumps.
Age: 83.0
Sex: F
Vaccine: VARZOS
Symptoms: Dry mouth, Dysphonia, Glossodynia, Mouth swelling, Tenderness
Clinical narrative: This case was reported by a pharmacist and described the occurrence of hoarseness in a 83-year-old female patient who received SHINGRIX (batch number 27K24, expiry date 2nd February 2021) and (batch number G47M2, expiry date unknown) for prophylaxis. On 9th May 2018, the patient received the 1st dose of SHINGRIX (intramuscular) .5 ml. On 9th May 2018, the dose was an unknown dose. In May 2018, 14 days after receiving SHINGRIX the patient experienced hoarseness, swollen mouth, tenderness, dry mouth and vocal cord dysfunction. On an unknown date, the patient experienced sensitive tongue. On an unknown date, the outcome of the hoarseness, swollen mouth, tenderness, dry mouth and vocal cord dysfunction were not recovered/not resolved and the outcome of the sensitive tongue was unknown. It was unknown if the reporter considered the hoarseness, swollen mouth, tenderness, sensitive tongue, dry mouth and vocal cord dysfunction to be related to SHINGRIX. Additional details were received as follows: The pharmacy intern reported that the patient experienced unusual voice hoarseness and swelling mouth, tenderness in unknown location and sensitivity to spicy foods. The pharmacy intern claimed that the information was already reported to GlaxoSmithKline, however no duplicate case with receipt date before 12th July 2018 was identified. The case US2018GSK125414 was found to be duplicate of US2018126880. Hence, case US2018GSK125414 will be a case of record and case US2018126880 will be deleted. Follow up information was received from the patient on 16th July 2018: The patient received the vaccine in the left shoulder. The patient also experienced dry mouth. Till the date of reporting and from the past 7 weeks to the date of reporting, the events experienced by the patient continued and were not resolved. The patient was referred to an ear nose and throat (ENT) specialist, who stated that she had irritated vocal cords. It was stated that, they were about to wait for another month after the date of reporting and if the events did not improve then they were about to carry out biopsy. The patient stated that, the only change she had in her life was vaccination with SHINGRIX prior to her issue with the vocal cords. The patient had allowed the safety department to contact her pharmacy and her doctor. The reporter's call was transferred to the Response Center, after obtaining all the safety information from the patient. The reporter reported that this information was previously reported to GlaxoSmithKline (GSK).
Age: 83.0
Sex: F
Vaccine: VARZOS
Symptoms: Vocal cord dysfunction
Clinical narrative: This case was reported by a pharmacist and described the occurrence of hoarseness in a 83-year-old female patient who received SHINGRIX (batch number 27K24, expiry date 2nd February 2021) and (batch number G47M2, expiry date unknown) for prophylaxis. On 9th May 2018, the patient received the 1st dose of SHINGRIX (intramuscular) .5 ml. On 9th May 2018, the dose was an unknown dose. In May 2018, 14 days after receiving SHINGRIX the patient experienced hoarseness, swollen mouth, tenderness, dry mouth and vocal cord dysfunction. On an unknown date, the patient experienced sensitive tongue. On an unknown date, the outcome of the hoarseness, swollen mouth, tenderness, dry mouth and vocal cord dysfunction were not recovered/not resolved and the outcome of the sensitive tongue was unknown. It was unknown if the reporter considered the hoarseness, swollen mouth, tenderness, sensitive tongue, dry mouth and vocal cord dysfunction to be related to SHINGRIX. Additional details were received as follows: The pharmacy intern reported that the patient experienced unusual voice hoarseness and swelling mouth, tenderness in unknown location and sensitivity to spicy foods. The pharmacy intern claimed that the information was already reported to GlaxoSmithKline, however no duplicate case with receipt date before 12th July 2018 was identified. The case US2018GSK125414 was found to be duplicate of US2018126880. Hence, case US2018GSK125414 will be a case of record and case US2018126880 will be deleted. Follow up information was received from the patient on 16th July 2018: The patient received the vaccine in the left shoulder. The patient also experienced dry mouth. Till the date of reporting and from the past 7 weeks to the date of reporting, the events experienced by the patient continued and were not resolved. The patient was referred to an ear nose and throat (ENT) specialist, who stated that she had irritated vocal cords. It was stated that, they were about to wait for another month after the date of reporting and if the events did not improve then they were about to carry out biopsy. The patient stated that, the only change she had in her life was vaccination with SHINGRIX prior to her issue with the vocal cords. The patient had allowed the safety department to contact her pharmacy and her doctor. The reporter's call was transferred to the Response Center, after obtaining all the safety information from the patient. The reporter reported that this information was previously reported to GlaxoSmithKline (GSK).
Age: 1.17
Sex: M
Vaccine: VARCEL
Symptoms: Erythema, Injection site erythema, Injection site swelling, Rash generalised, Varicella post vaccine
Clinical narrative: Baby had extreme redness and swelling at injection site as well as red pox completely covering his body 10 days after receiving the vaccine.
Age: 62.0
Sex: F
Vaccine: VARZOS
Symptoms: Chills, Diarrhoea, Feeling abnormal, Injection site erythema, Injection site swelling
Clinical narrative: 5 inch red swollen patch by shot, severe itchy hives on neck, back chest and down arms, nausea, severe diarrhea, chills but no fever, feel horrible, haven't been this sick in years.
Age: 62.0
Sex: F
Vaccine: VARZOS
Symptoms: Malaise, Nausea, Pruritus, Urticaria
Clinical narrative: 5 inch red swollen patch by shot, severe itchy hives on neck, back chest and down arms, nausea, severe diarrhea, chills but no fever, feel horrible, haven't been this sick in years.
Age: 55.0
Sex: M
Vaccine: VARZOS
Symptoms: Dizziness, Pyrexia
Clinical narrative: Low grade fever, lightheaded.
Age: 56.0
Sex: M
Vaccine: VARZOS
Symptoms: Chills, Fatigue, Headache, Nausea, Pain in extremity
Clinical narrative: Sore arm, headache, nausea, chills, fatigue.
Age: 75.0
Sex: F
Vaccine: VARZOS
Symptoms: Bed rest, Pain, Periarthritis, Tenderness
Clinical narrative: Unable to use left shoulder joint at all for 36 hours...totally frozen. Severe pain for 24 hours controlled w TYLENOL 1000mg q4h. Iced area for 12 hours. Bedrest. Started easy into movement in 3 days and able to use joint in 5 days. Continues to be tender at 1 week.
Sex: F
Vaccine: HPV9
Symptoms: Exposure during pregnancy
Clinical narrative: This spontaneous prospective pregnancy report was received from a female patient of unknown age who was reporting on herself. The patient's concurrent conditions, medical history and concomitant therapies were not reported. The patient was pregnant. Date of last menstrual period, estimated due date, trimester of exposure, prenatal tests and test results were not reported. On an unspecified date, while being pregnant, the patient was vaccinated with a dose of GARDASIL 9 intramuscular injection (strength, exact dose, frequency, lot # and expiration date were not reported) for prevention of human papilloma virus (HPV). The patient sought medical attention at doctor office visit. There was no hospitalization and no treatment given. Product quality complaint was not involved. The pregnancy outcome was pending, fetal outcome was unknown. The outcome of vaccine exposure during pregnancy was unknown.
Age: 11.0
Sex: F
Vaccine: HPV9, MNQ, TDAP
Symptoms: Urticaria
Clinical narrative: This spontaneous report as received from a physician refers to an 11-year-old female patient. The patient's pertinent medical history included seasonal allergy. They had no any drug reactions or allergies. She did not take any concomitant medications. On 11-JUN-2018, the patient was vaccinated on the right arm with an unspecified dose of GARDASIL 9 (injection, intramuscularly, lot # N013698 and expiration date 19-DEC-2019), MENVEO and, on the left arm, with BOOSTRIX (dose, route of administration, lot# and expiration date were not provided for both). On 12-JUN-2018, at home, the patient developed urticaria on the right arm. On 13-JUN-2018, she was seen by physician at the office, who confirmed the event. No lab diagnostics or studies were performed. There was unspecified treatment given for the urticaria. On 14-JUN-2018, the patient's urticaria was resolved. Causality assessment was not provided.
Sex: U
Vaccine: RV5
Symptoms: Expired product administered, No adverse event
Clinical narrative: This spontaneous report was received from a pharmacist and refers to a patient of unknown age and gender. The patient's concurrent conditions, medical history and concomitant therapies were not reported. The pharmacist reported that in one of their clinics, on 05-JUL-2018, the patient was inadvertently administered with a dose of ROTATEQ orally, lot # M046008 (exact dose was not reported), which expired on 29-JUN-2018. No adverse effects were reported.
Age: 64.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site pruritus, Injection site rash
Clinical narrative: This spontaneous report as received from a pharmacist via a company representative concerning a 64-year-old female patient. The patient's pertinent medical history, concomitant medications and drug reactions or allergies were not reported. On 02-JUL-2018, the patient was vaccinated with a dose of ZOSTAVAX lot # N026815, expiration date 25-DEC-2018 (exact dose and route of administration were not reported) for prophylaxis. The vaccine was reconstituted with sterile diluent (lot # and expiration date were not reported). On an unknown date after the vaccination, in July 2018, the patient experienced rash and itching at injection site. The patient sought medical attention by calling the pharmacist. The pharmacist recommended the patient to use ice, unspecified topical steroids and BENADRYL as treatment. On 07-JUL-2018, the patient called the pharmacy and reported that rash had resolved (reported as rash had cleared up, the exact date was not reported). The causality assessment between the events and suspect therapies was not provided.
Age: 0.33
Sex: M
Vaccine: HEP
Symptoms: Extra dose administered, No adverse event
Clinical narrative: This spontaneous report was received from a licensed practical nurse referring to a 4 month old male patient. Information on patient's pertinent medical history, drug reactions/allergies and concomitant medications were not reported. On an unknown date at his 4 month visit, the patient was vaccinated with a dose of RECOMBIVAX HB (strength, dose, route, lot # and expiry date were not reported) for prophylaxis. On an unknown date (5 days later), the patient was vaccinated with another dose of RECOMBIVAX HB in error (inappropriate schedule of drug administration). No details about the doses were known except that doses were 5 days apart. No adverse effects were reported. There was no product quality complaint (PQC) reported.
Sex: U
Vaccine: HPV9
Symptoms: Inappropriate schedule of drug administration, No adverse event
Clinical narrative: This spontaneous report was received from a registered nurse and refers to a patient of unknown gender and age. The patient's concurrent conditions, medical history and concomitant therapies were not reported. On July 2015, reported as "3 years ago", the patient was vaccinated with his first dose of GARDASIL for prophylaxis (strength, dose, route, frequency, lot/batch # and expiration date were not reported). At the time of reporting, the patient was currently in the office to receive the second dose in the series with GARDASIL 9. No adverse effects were reported.
Age: 12.0
Sex: M
Vaccine: HPV9
Symptoms: Blood pressure decreased, Pallor, Vomiting
Clinical narrative: This spontaneous report was received from a nurse via a company representative and refers to a 12-year-old male patient. No information regarding the patient's pertinent medical history, drug reactions or allergies and concomitant therapies was provided. On unknown date, patient was vaccinated with a dose of GARDASIL 9 for prevention of human papilloma virus (HPV) (dose, route of administration, lot# and expiration date were not reported). On unknown date in June 2018, reported as with past month and on unspecified time after receiving the vaccine, the patient's blood pressure dropped, he became pale white for 15 minutes and then vomited. The patient did not receive any treatment for the events. The patient recovered from the events on an unknown date in 2018. The relatedness between the events and GARDASIL 9 was not reported.
Sex: M
Vaccine: MMR
Symptoms: Incorrect route of drug administration, No adverse event
Clinical narrative: This spontaneous report as received from a pharmacist refers to male patient possibly in his forties. There was no information about the patient's pertinent medical history, concomitant therapies or drug reactions and allergies provided. On 17-JUL-2018 (also reported as "today"), the patient was improperly vaccinated with a dose of M-M-R II injection, intramuscularly not subcutaneously as recommended, for prophylaxis (exact dose, lot# and expiration date were unknown). No adverse effects reported.
Age: 5.0
Sex: M
Vaccine: MMRV
Symptoms: Antinuclear antibody, Blood test, Cerebral haemorrhage, Computerised tomogram, Contusion
Clinical narrative: Information has been received from a consumer, referring to a 12 months old male patient. The patient had ear tube insertion and penicillin allergy. There were no concomitant medications. On 22-APR-2011, the patient was vaccinated with the first dose of PROQUAD (dose, strength, expiration date and lot# unknown), intramuscular. On 14-AUG-2015, the patient was vaccinated with the last dose of PROQUAD (dose, strength, expiration date and lot# unknown), intramuscular, both for prophylaxis as scheduled (Incorrect route of drug administration). On an unknown date, the patient experienced "bruise much more easily". On 19-APR-2016, the patient experienced "covered in petechiae and bruising" and was taken to see an unspecified physician. The patient had a platelet count of 7000 (unit unspecified) and was admitted to hospital after being diagnosed with idiopathic thrombocytopenia. The patient had multiple intravenous immunoglobulin (IVIG) treatment, multiple courses of dexamethasone and prednisone. The patient had been admitted to the hospital on for separate occasions including for an unspecified time in the summer of 2017 for a brain bleed that required long term treatment. On unknown dates the patient had auto-immune testing, multiple computed tomography (CT) scans, Magnetic Resonance Imaging (MRI), platelet testing, Antinuclear Antibody (ANA) testing and blood draws 6-8 times per month. The outcome of idiopathic thrombocytopenia and "bruise much more easily" was reported as not recovered. The causality assessment was not reported. Upon internal review, idiopathic thrombocytopenia was determined to be medically significant.
Age: 5.0
Sex: M
Vaccine: MMRV
Symptoms: Immune thrombocytopenic purpura, Immunoglobulin therapy, Immunology test, Incorrect route of drug administration, Increased tendency to bruise
Clinical narrative: Information has been received from a consumer, referring to a 12 months old male patient. The patient had ear tube insertion and penicillin allergy. There were no concomitant medications. On 22-APR-2011, the patient was vaccinated with the first dose of PROQUAD (dose, strength, expiration date and lot# unknown), intramuscular. On 14-AUG-2015, the patient was vaccinated with the last dose of PROQUAD (dose, strength, expiration date and lot# unknown), intramuscular, both for prophylaxis as scheduled (Incorrect route of drug administration). On an unknown date, the patient experienced "bruise much more easily". On 19-APR-2016, the patient experienced "covered in petechiae and bruising" and was taken to see an unspecified physician. The patient had a platelet count of 7000 (unit unspecified) and was admitted to hospital after being diagnosed with idiopathic thrombocytopenia. The patient had multiple intravenous immunoglobulin (IVIG) treatment, multiple courses of dexamethasone and prednisone. The patient had been admitted to the hospital on for separate occasions including for an unspecified time in the summer of 2017 for a brain bleed that required long term treatment. On unknown dates the patient had auto-immune testing, multiple computed tomography (CT) scans, Magnetic Resonance Imaging (MRI), platelet testing, Antinuclear Antibody (ANA) testing and blood draws 6-8 times per month. The outcome of idiopathic thrombocytopenia and "bruise much more easily" was reported as not recovered. The causality assessment was not reported. Upon internal review, idiopathic thrombocytopenia was determined to be medically significant.
Age: 5.0
Sex: M
Vaccine: MMRV
Symptoms: Nuclear magnetic resonance imaging, Petechiae, Platelet count decreased
Clinical narrative: Information has been received from a consumer, referring to a 12 months old male patient. The patient had ear tube insertion and penicillin allergy. There were no concomitant medications. On 22-APR-2011, the patient was vaccinated with the first dose of PROQUAD (dose, strength, expiration date and lot# unknown), intramuscular. On 14-AUG-2015, the patient was vaccinated with the last dose of PROQUAD (dose, strength, expiration date and lot# unknown), intramuscular, both for prophylaxis as scheduled (Incorrect route of drug administration). On an unknown date, the patient experienced "bruise much more easily". On 19-APR-2016, the patient experienced "covered in petechiae and bruising" and was taken to see an unspecified physician. The patient had a platelet count of 7000 (unit unspecified) and was admitted to hospital after being diagnosed with idiopathic thrombocytopenia. The patient had multiple intravenous immunoglobulin (IVIG) treatment, multiple courses of dexamethasone and prednisone. The patient had been admitted to the hospital on for separate occasions including for an unspecified time in the summer of 2017 for a brain bleed that required long term treatment. On unknown dates the patient had auto-immune testing, multiple computed tomography (CT) scans, Magnetic Resonance Imaging (MRI), platelet testing, Antinuclear Antibody (ANA) testing and blood draws 6-8 times per month. The outcome of idiopathic thrombocytopenia and "bruise much more easily" was reported as not recovered. The causality assessment was not reported. Upon internal review, idiopathic thrombocytopenia was determined to be medically significant.
Sex: F
Vaccine: VARCEL
Symptoms: Varicella post vaccine
Clinical narrative: This spontaneous report was received from a physician referring to a female patient of unknown age. The patient's pertinent medical history, concurrent conditions, relevant past drug history and concomitant medications were unknown. On 12-JUL-2018, also reported as "10 days ago in July 2018", the patient received an unknown dose of VARIVAX for prophylaxis (strength and route of administration were not provided, and lot # and expiration date could not be requested). On 22-JUL-2018, the patient called stating she got chicken pox (varicella). Relevant laboratory data was unknown. It was unknown if the patient would got VARIVAX again. Additionally, it was unknown if the physician was also the prescriber. At the reporting time, the chicken pox continued. The causality assessment between the aforementioned adverse event and VARIVAX was not provided.
Age: 4.0
Sex: M
Vaccine: MMR, VARCEL
Symptoms: Cellulitis, Injection site swelling
Clinical narrative: This spontaneous report has been received from an office manager, via a company representative, referring to a 4 years old male patient. Information about the patient's pertinent medical history, concomitant medications, drug reactions and allergies was unknown by the reporter. On 15-JUL-2018, the patient was vaccinated with VARIVAX and M-M-R II for prevention (dose numbers and frequencies were not provided; routes and anatomical locations of administration, lot numbers and expiration dates were unknown by the reporter). On 16-JUL-2018, the patient developed swelling of an unspecified leg, which continued until 17-JUL-2018, when the patient visited the physician for medical attention and was diagnosed with cellulitis. The physician prescribed KEFLEX as treatment. It was unknown by the reporter if any laboratory or other diagnostic studies were performed to the patient. By reporting time, the patient was recovering from cellulitis. The reporter did not provide the causality assessment for cellulitis occurrence in regards with VARIVAX and M-M-R II vaccination. Upon internal review, cellulitis was determined to be a medically significant event.
Sex: F
Vaccine: PPV
Symptoms: Pruritus, Throat irritation, Urticaria
Clinical narrative: Information has been received from a registered nurse via field representative, referring a 56 year old female patient. The patient's current condition included meat allergy, information of concomitant therapy and historical condition was unknown. On 10-JUL-2018 the patient was vaccinated with PNEUMOVAX 23 0.5 ml, in the left deltoid (route, lot# and expiration date unknown) for prophylaxis.  At 17:00, soon after the administration, the patient had itching and hives and took diphenhydramine hydrochloride (BENADRYL), At 21:00 of the same night, the patient went to the emergency room (ER), with complaining of throat itching but no throat swelling and no airway restriction. the patient was administered IV famotidine (PEPCID), diphenhydramine hydrochloride (BENADRYL) and dexamethasone(DECADRON )one bag fluids. Then the patient was sent home with a prescription for methylprednisolone (MEDROL DOSEPAK) and ondansetron hydrochloride (ZOFRAN). The physician verified that the prescription information (PI) for PNEUMOVAX 23 did not contain any bovine product prior to administration. The outcome of itching and hives, throat itching were unknown. The causality assessment was not provided by the reporter. Upon internal review, itching and hives, throat itching were determined to be medically significant.
Sex: U
Vaccine: VARCEL
Symptoms: No adverse event, Product storage error
Clinical narrative: This spontaneous report was received from a nurse and refers to a patient of unknown age and gender. The patient's concomitant medications, pertinent medical history, drug reactions or allergies were not reported. On 21-JUL-2018, the patient was vaccinated with one dose of improperly stored VARIVAX lot # N035940, expiration date 21-JUL-2018, for prophylaxis (route of administration was not reported). Temperature of storage was reported as: -14 Celsius degrees to -10 Celsius degrees, time frame 1 hour. There was no previous temperature excursion. Digital data logger was involved. No adverse effect reported.
Sex: U
Vaccine: HIBV
Symptoms: No adverse event, Product storage error
Clinical narrative: This spontaneous report has been received from a licensed practical nurse referring to a patient of unknown age and gender. Information regarding the patient's medical history, drug reactions or allergies, concurrent conditions and concomitant medications was not reported. On 16-JUL-2018, the patient was vaccinated with an improperly stored dose of LIQUID PEDVAXHIB lot # N012921 with expiration date of 28-FEB-2020 (strength, dose, frequency, route, anatomical location, lot number and expiration date were not provided) for prophylaxis. No adverse effects were reported. The vaccine was exposed to a temperature excursion of 69 °F, during a time frame of 84 hours which was called by a data logger. Previous temperature excursions included 47°F to 77°F for 13 hours in June 2018.
Sex: U
Vaccine: HEP
Symptoms: Expired product administered, No adverse event
Clinical narrative: This spontaneous report was received from a medical assistant, concerning a patient of unknown age and gender. No information was provided regarding the patient's medical history, concurrent conditions or concomitant medications. On 24-JUL-2018, the patient received an expired dose of RECOMBIVAX HB, per intramuscular route, lot # M033096 and expiration date on 31-MAY-2018, for prophylaxis. No adverse events were reported for the patient.
Sex: U
Vaccine: PPV, RV5
Symptoms: No adverse event, Product storage error
Clinical narrative: This spontaneous report was received from a nurse referring to an unspecified number of patients of unknown age and gender. The patients' pertinent medical history, drug reactions/allergies, concurrent conditions and concomitant medications were not reported. On unknown dates, the patients were vaccinated an improperly stored dose of with PNEUMOVAX 23 (route of administration was not reported) lot # N011305 with expiration date 20-JAN-2019, lot # N025656 with expiration date 19-APR-2019 (also reported as "09-APR-2019"); or ROTATEQ per oral, lot # N029868 with expiration date 12-MAR-2019 and lot # reported as N0234400 with expiration date reported as 10-MAY-2019; both for prophylaxis. No adverse effects were reported. It was reported that the vaccines were exposed to a temperature between 9 to 25 (13.6) Celsius degrees for 17 hours. No previous temperature excursion was reported. A digital data logger was involved. Lot number N0234400 is an invalid lot number for ROTATEQ.
Age: 17.0
Sex: M
Vaccine: MMRV
Symptoms: Drug administered to patient of inappropriate age, No adverse event
Clinical narrative: This spontaneous report as received from a registered nurse via a company representative refers to a 17-year-old male patient. There was no information about the patient's pertinent medical history, concomitant therapies or drug reactions and allergies provided. On an unknown date, the patient at the age of 17 was vaccinated in error with PROQUAD for prophylaxis (exact dose, route of administration, lot# and expiration date were unknown). No adverse effects were reported.
Sex: F
Vaccine: VARZOS
Symptoms: Back pain, Burning sensation, Herpes zoster, Neck pain, Pain
Clinical narrative: Information has been received from a lawyer regarding a case in litigation concerning a female patient of unknown age. No information was provided regarding the patient's past medical history, concurrent conditions, or concomitant medication.  On or about 27-AUG-2015, the patient was inoculated with ZOSTAVAX (lot number, dosage and route of administration not provided) at a health care facility/office for routine health maintenance and for the prevention of shingles. The ZOSTAVAX did not prevent shingles, but rather caused the patient to contract a persistent strain of herpes zoster. Shortly after receiving ZOSTAVAX vaccine, the patient developed a burning sensation and shooting pain originating in her upper back and radiating into her neck. In response to these complaints, the patient presented to her primary care physician and was diagnosed as suffering from shingles. As a direct and proximate result of these malfunctions, the patient suffered painful injuries and damages, and required extensive medical care and treatment. As a further proximate result, the patient has suffered and will continue to suffer significant medical expenses, and pain and suffering, and other damages. The reporter considered the events to be related to ZOSTAVAX. The outcome of the events was unknown.  Additional information has been requested.
Sex: F
Vaccine: VARZOS
Symptoms: Herpes zoster
Clinical narrative: Information has been received from a lawyer regarding a case in litigation concerning a female patient of unknown age. No information was provided regarding the patient's past medical history, concurrent conditions, or concomitant medication. On or about 17-AUG-2015, the patient was inoculated with ZOSTAVAX (lot number, dosage and route of administration not provided) at a health care facility/office "routine health maintenance and for the prevention of shingles." The vaccine did not prevent shingles, but rather caused the patient to contract a persistent strain of herpes zoster. Shortly after receiving ZOSTAVAX vaccine, the patient was diagnosed as suffering from shingles. As a direct and proximate result of these malfunctions, the patient suffered painful injuries and damages, and required extensive medical care and treatment. As a further proximate result, the patient has suffered and will continue to suffer significant medical expenses, and pain and suffering, and other damages. The reporter considered the events to be related to ZOSTAVAX.  The outcome of the events was unknown. Additional information has been requested.
Sex: U
Vaccine: HEPA
Symptoms: Inappropriate schedule of drug administration, Incorrect drug administration duration, No adverse event
Clinical narrative: This spontaneous report was received from a pharmacy intern and refers to an adult patient of unknown age and gender. The patient's relevant medical history, concurrent conditions and concomitant medications were unknown. On JUL-2018 (reported as 3 months ago), the patient was vaccinated with the first dose of VAQTA for prophylaxis (dose, strength, frequency, route of administration, lo# and expiration date were unknown). On JUL-2018 (reported as a few days ago), the patient was vaccinated with a second dose of VAQTA 0.5/1.0 U/ml, intramuscularly, for prophylaxis, lot # R000180 and expiration date 31-MAR-2019. No adverse effects were reported.
Sex: F
Vaccine: VARZOS
Symptoms: Herpes zoster, Musculoskeletal pain, Neuralgia, Rash
Clinical narrative: Information has been received on 25-JUL-2018 regarding a case in litigation from a lawyer and a female consumer of unknown age. The patient's concurrent conditions, medical history and concomitant medications are unknown. On or about 01-APR-2015, the patient was inoculated with ZOSTAVAX (lot number and expiration unknown) unknown route from her primary care physician for routine health maintenance and for the prevention of shingles. The vaccine did not prevent shingles but rather caused the patient to contract a persistent strain of herpes zoster. Shortly after receiving the ZOSTAVAX, the patient developed nerve pain on the left side of her body and a painful rash along her midsection. In response to these complaints, the patient presented to a rheumatology physician's office with complaints of shoulder pain and was diagnosed as suffering from shingles. As a direct and proximate result of these malfunctions, the patient suffered painful injuries and damages, and required extensive medical care and treatment. As a further proximate result, the patient has suffered and will continue to suffer significant medical expenses and pain and suffering and other damages. Additional information has been requested.
Age: 14.0
Sex: U
Vaccine: HPV9
Symptoms: Inappropriate schedule of drug administration, No adverse event
Clinical narrative: This spontaneous report was received from a employee refers to a 14 year old patient of an unknown gender. The patient's relevant medical history, concurrent condition and concomitant medication were not reported. On an unknown date in July-2017, the patient was vaccinated with first dose of GARDASIL 9 injection, for prophylaxis (lot#, expiry date, route and dosage details were not reported). On 25-JUL-2018, the patient was vaccinated with second dose of GARDASIL 9 injection, for prophylaxis (lot#, expiry date, route and dosage details were not reported). No adverse effects were reported. No product quality complaint (PQC) was involved.
Sex: U
Vaccine: HPV9
Symptoms: Inappropriate schedule of drug administration, No adverse event
Clinical narrative: This spontaneous report was received from a registered nurse and refers to a patient of unknown age and gender. The patient's medical history, concurrent conditions and concomitant therapies were no provided. The registered nurse stated that on 24-MAR-2018, the patient received a dose of GARDASIL 9, intramuscularly, for prophylaxis, lot# N032284, expiration date: 22-SEP-2020 (strength and dosage were no provided) and another doses of GARDASIL 9 intramuscularly for prophylaxis (strength, dosage, lot# and expiration date were no reported), were administered to the patient on 18-MAY-2018 and 27-JUL-2018, not in accordance with the prescribing information. No adverse effects were reported.
Age: 15.0
Sex: F
Vaccine: HPV9
Symptoms: Blood pressure abnormal, Flushing, Loss of consciousness, Pulse abnormal, Syncope
Clinical narrative: This spontaneous report was received from a physician, via a company representative, referring to a 15 year old female patient. The patient's relevant medical history, drug reactions/allergies and concomitant medication were not reported. Prior vaccination, the patient's blood pressure was 144/96 (units were not provided) and she was very anxious. On 27-JUL-2018 at 10:00, the patient was vaccinated with the second dose of GARDASIL 9 for prevention of human papilloma virus (HPV) (strength, route, dosage schedule, lot number and expiration date were not reported). On the same day, 15 minutes after vaccination the patient experienced ringing in her ears, facial flushing and started to pass out. During the adverse event the patient's blood pressure was 85/56 (blood pressure abnormal) and pulse was 51 (pulse abnormal) (no further details were provided). The patient sought medical attention but it was unknown by the reporter if she received treatment. The outcome of ringing in her ears, facial flushing, syncope, blood pressure abnormal and pulse abnormal was reported as recovered on 27-JUL-2018. Causality assessment was not provided.
Age: 15.0
Sex: F
Vaccine: HPV9
Symptoms: Tinnitus
Clinical narrative: This spontaneous report was received from a physician, via a company representative, referring to a 15 year old female patient. The patient's relevant medical history, drug reactions/allergies and concomitant medication were not reported. Prior vaccination, the patient's blood pressure was 144/96 (units were not provided) and she was very anxious. On 27-JUL-2018 at 10:00, the patient was vaccinated with the second dose of GARDASIL 9 for prevention of human papilloma virus (HPV) (strength, route, dosage schedule, lot number and expiration date were not reported). On the same day, 15 minutes after vaccination the patient experienced ringing in her ears, facial flushing and started to pass out. During the adverse event the patient's blood pressure was 85/56 (blood pressure abnormal) and pulse was 51 (pulse abnormal) (no further details were provided). The patient sought medical attention but it was unknown by the reporter if she received treatment. The outcome of ringing in her ears, facial flushing, syncope, blood pressure abnormal and pulse abnormal was reported as recovered on 27-JUL-2018. Causality assessment was not provided.