chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 26.0
Sex: F
Vaccine: TDAP
Symptoms: Exposure during pregnancy, Product storage error
Clinical narrative: Initial pregnancy report received on 13-Aug-2018 regarding an unsolicited valid non-serious case received from a other health professional. This case is linked to case 2018SA225852 (same reporter). This case involves adult female patient (age not reported), who was exposed to 0.5 ml dose of vaccine ADACEL (Batch number: U5979AA and expiry date: 13-Jun-2020) (dose in series and route was not reported) in the right deltoid on 09-Aug-2018, while she was pregnant. The date of last menstrual period was not reported. The estimated due date was not reported. It was reported that the patient was in her 29 weeks 4 days of gestation. The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided. Concomitant medications were not reported. The patient had no previous pregnancy/ies. It was a case of actual medication error due to incorrect product storage because the patient received injection that was out of shipping stability. It was also a case of vaccine exposure during pregnancy. It was unknown if any adverse event was occurred or not following the vaccination. This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holder's compliance with the requirements set out in Directive and Module VI of the Good Pharmacovigilance Practices. The classification as a medical error is in no way intended, nor should it be interpreted or construed as an allegation or claim made by the marketing authorization holder that any third party has contributed to or is to be held liable for the occurrence of this medication error.  Documents held by the sender: None.
Age: 56.0
Sex: F
Vaccine: VARZOS
Symptoms: Chills, Discomfort, Headache, Hyperhidrosis, Influenza like illness
Clinical narrative: I took one 500 mg acetaminophen tablet after receiving the vaccine. In the middle of the night, I awoke with flu like symptoms - sweats, chills, muscle aches, nausea and headache. They were mild, but uncomfortable. Symptoms lasted until 11:00 the next morning.
Age: 56.0
Sex: F
Vaccine: VARZOS
Symptoms: Middle insomnia, Myalgia, Nausea
Clinical narrative: I took one 500 mg acetaminophen tablet after receiving the vaccine. In the middle of the night, I awoke with flu like symptoms - sweats, chills, muscle aches, nausea and headache. They were mild, but uncomfortable. Symptoms lasted until 11:00 the next morning.
Age: 19.0
Sex: F
Vaccine: MENB
Symptoms: Dizziness, Dyspnoea, Pyrexia
Clinical narrative: 4 hours after vaccine patient complained to mom of dizziness and shortness of breath. Mom states patient had fever, but did not take temperature. Mom listened to patient and she was not wheezing.
Age: 75.0
Sex: M
Vaccine: VARZOS
Symptoms: Dizziness, Loss of consciousness
Clinical narrative: Patient was light headed and dizzy for about a week, including he passed out the day after the vaccine.
Age: 75.0
Sex: F
Vaccine: VARZOS
Symptoms: Dizziness
Clinical narrative: Patient felt light headed for a few days after the vaccination.
Age: 76.0
Sex: F
Vaccine: VARZOS
Symptoms: Impaired work ability, Incomplete course of vaccination, Inflammation, Pain in extremity, Rash
Clinical narrative: Painful itchy rash on legs, back, front torso and arms. Has persisted for over 2 months. As of 8-22-2018 my lower arms are still inflamed and painful. Took steroids when it became too bad for me to go to work. Will not get 2nd dose as recommended.
Age: 76.0
Sex: F
Vaccine: VARZOS
Symptoms: Rash pruritic
Clinical narrative: Painful itchy rash on legs, back, front torso and arms. Has persisted for over 2 months. As of 8-22-2018 my lower arms are still inflamed and painful. Took steroids when it became too bad for me to go to work. Will not get 2nd dose as recommended.
Age: 71.0
Sex: F
Vaccine: VARZOS
Symptoms: Axillary pain, Back pain, Neck pain, Pain in extremity
Clinical narrative: Normal arm pain. plus pain under the arm and pain radiating to center of back and up the left side of neck. Pain started radiating to neck at day 5 and symptoms lasted until 8-21-18.
Age: 53.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site cellulitis, Injection site erythema, Injection site swelling
Clinical narrative: PATIENT DEVELOPED CELLULITIS OF INJECTED ARM (REDNESS AND SWELLING OF SKIN ONLY) EXTENDING FROM INJECTION SITE DOWN FOREARM OVER THE COURSE OF TWO DAYS FOLLOWING INJECTION. PATIENT TREATED WITH CEPHALEXIN 500 MG 1 CAPSULE TWO TIMES A DAY FOR UNKNOWN DURATION (LIKELY 7-10 DAYS), RESULTING IN DISAPPEARANCE OF SYMPTOMS.
Age: 1.0
Sex: M
Vaccine: HEPA, MMR, VARCEL
Symptoms: Aphasia, Blood lead, Diet refusal, Differential white blood cell count, Ear infection
Clinical narrative: Immediately following the vaccines administered on December 1, 2017 we noticed our son was sleeping more, developed a rash, rosy cheeks and a fever and ear infection that lasted two weeks. Shortly thereafter he stopped talking and refusing to eat. In February 2017 we noticed no signs of improvements and made an appointment with his pediatrician to address our concerns. Appointment made for March 9, 2017,
Age: 1.0
Sex: M
Vaccine: HEPA, MMR, VARCEL
Symptoms: Erythema, Full blood count, Immediate post-injection reaction, Pyrexia, Rash
Clinical narrative: Immediately following the vaccines administered on December 1, 2017 we noticed our son was sleeping more, developed a rash, rosy cheeks and a fever and ear infection that lasted two weeks. Shortly thereafter he stopped talking and refusing to eat. In February 2017 we noticed no signs of improvements and made an appointment with his pediatrician to address our concerns. Appointment made for March 9, 2017,
Age: 1.0
Sex: M
Vaccine: HEPA, MMR, VARCEL
Symptoms: Somnolence
Clinical narrative: Immediately following the vaccines administered on December 1, 2017 we noticed our son was sleeping more, developed a rash, rosy cheeks and a fever and ear infection that lasted two weeks. Shortly thereafter he stopped talking and refusing to eat. In February 2017 we noticed no signs of improvements and made an appointment with his pediatrician to address our concerns. Appointment made for March 9, 2017,
Age: 0.75
Sex: F
Vaccine: HEP
Symptoms: Abnormal behaviour, Agitation, Decreased appetite, Diarrhoea, Head banging
Clinical narrative: 8/15/18 - 8/19/18 : Agitation, insomnia, screaming in sleep once patient does fall asleep. 8/20/18 - 8/21/18: Agitation, insomnia, screaming in sleep once patient does fall asleep, lack of appetite, rash around neck and scalp, abnormal behavior - banging head against wall. 8/22/18: Agitation, insomnia, screaming in sleep once patient does fall asleep, lack of appetite, rash around neck and scalp, diarrhea. Patient was taken to the clinic 8/22/2018 with complaints of the above symptoms, physical exam was given, Dr. didn't feel medical treatment was necessary. Refused to acknowledge this vaccination has reactions and would not treat patient or run lab tests.
Age: 0.75
Sex: F
Vaccine: HEP
Symptoms: Insomnia, Rash, Screaming
Clinical narrative: 8/15/18 - 8/19/18 : Agitation, insomnia, screaming in sleep once patient does fall asleep. 8/20/18 - 8/21/18: Agitation, insomnia, screaming in sleep once patient does fall asleep, lack of appetite, rash around neck and scalp, abnormal behavior - banging head against wall. 8/22/18: Agitation, insomnia, screaming in sleep once patient does fall asleep, lack of appetite, rash around neck and scalp, diarrhea. Patient was taken to the clinic 8/22/2018 with complaints of the above symptoms, physical exam was given, Dr. didn't feel medical treatment was necessary. Refused to acknowledge this vaccination has reactions and would not treat patient or run lab tests.
Age: 76.0
Sex: M
Vaccine: PNC13
Symptoms: Asthenia, Chest discomfort, Confusional state, Excessive eye blinking, Feeling abnormal
Clinical narrative: About 12 minutes after receiving immunization I heard patient's wife ask him if he was okay, went to patient and saw him keep blinking and looking off. He was not talking as much and seemed confused. I grabbed the NP and patient told her that his vision was blurrier than normal and he did not feel right in the head. Patient then started to experience some chest discomfort. Got BP on patient, it was 158/79. NP listened to his chest with a stethoscope and said he should probably go to the ER. Wheeled patient over to the ER, he had a hard time getting into the chair and prior to immunization he had been getting around just fine. While wheeling over, chest pain was worsening and he was feeling weak. Upon entering ER, they got him right back.
Age: 76.0
Sex: M
Vaccine: PNC13
Symptoms: Vision blurred
Clinical narrative: About 12 minutes after receiving immunization I heard patient's wife ask him if he was okay, went to patient and saw him keep blinking and looking off. He was not talking as much and seemed confused. I grabbed the NP and patient told her that his vision was blurrier than normal and he did not feel right in the head. Patient then started to experience some chest discomfort. Got BP on patient, it was 158/79. NP listened to his chest with a stethoscope and said he should probably go to the ER. Wheeled patient over to the ER, he had a hard time getting into the chair and prior to immunization he had been getting around just fine. While wheeling over, chest pain was worsening and he was feeling weak. Upon entering ER, they got him right back.
Age: 82.0
Sex: F
Vaccine: VARZOS
Symptoms: Chills, Headache, Injection site erythema, Injection site pruritus, Injection site swelling
Clinical narrative: Patient woke up in the morning and arm around site was red, hot, swollen, severe headache and chills which lasted into the next day, after four days the site is still swollen, red, and itchy now.
Age: 82.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site warmth
Clinical narrative: Patient woke up in the morning and arm around site was red, hot, swollen, severe headache and chills which lasted into the next day, after four days the site is still swollen, red, and itchy now.
Age: 44.0
Sex: F
Vaccine: MMR, TDAP
Symptoms: Injected limb mobility decreased, Pain in extremity, Tenderness
Clinical narrative: Client reports on 8/22/18 to RN " right arm has been hurting, tender, and can't hardly move it ever since I got those shots in it back on 08/08/18."
Age: 16.0
Sex: M
Vaccine: HPV9, MENB, MNQ
Symptoms: Cold sweat, Pallor, Presyncope, Pulse abnormal, Syncope
Clinical narrative: Pt. had a fainting (vasovagal-like episode) Turned pale/clammy and Pulse was thready although VS were stable Pulse approximately 60/Needed O2 for about 10 mins/Laid supine/got better. Discharged with father stable VS.
Sex: F
Vaccine: HPV9
Symptoms: Induration, Nodule, Tenderness
Clinical narrative: This spontaneous report was received from a pharmacist and refers to a female patient of unknown age. No information regarding the patient's pertinent medical history, drug reactions or allergies and concomitant medications was provided. On 05-JUL-2018, the patient was vaccinated with the second dose of GARDASIL 9 (dose, route of administration, lot# and expiration date were not reported) for prophylaxis. On an unknown date in July 2018, the patient's arm developed a hard knot bump and was very tender to the touch. The patient sought medical attention. The outcome of the events and the causal relationship between the events and GARDASIL 9 were not provided.
Sex: M
Vaccine: MMR
Symptoms: Circumstance or information capable of leading to medication error, Expired product administered, Immunisation, No adverse event, Underdose
Clinical narrative: This spontaneous report has been received from a registered nurse referring to a currently 3 years old male patient. Concomitant medication included sterile diluent( MERCK STERILE DILUENT). The patient's concurrent conditions, medical history, and historical drugs were not reported. On an unspecified date in 2016, the patient was inadvertently vaccinated an expired dose of M-M-R II (dose, route, lot number and expiration date were not reported) for prophylaxis. On 09-AUG-2018, the patient returned to be revaccinated with another dose of M-M-R II (rHA), "subcutaneous in the right arm", lot# N013866, expiration date 04-MAY-2019. The Nurse reported "because the patient did not want to receive the dose, he was squirming during administration, and some of the dose sprayed out of the syringe, and he did not receive the full dose (accidental underdose). No adverse effects reported. This is one of three reports received from the same source.; Sender's Comments: US-009507513-1808USA004703: US-009507513-1808USA004943:
Sex: M
Vaccine: VARZOS
Symptoms: Blindness unilateral, Eye irritation, Eye laser surgery, Eye pain, Headache
Clinical narrative: This initial spontaneous report was received from a lawyer regarding a case in litigation and refers to a male patient of unknown age. No information was provided regarding concomitant medications, concurrent conditions or medical history. On or about 16-APR-2013, the patient was inoculated with the ZOSTAVAX vaccine as recommended for routine health maintenance and for the prevention of shingles (dose, route, and lot # not provided). The vaccine did not prevent shingles but rather caused the patient to contract a persistent and severe strain of herpes zoster. After receiving the ZOSTAVAX vaccine (date not reported), the patient developed burning, pain, and light sensitivity in his left eye, accompanied by headaches. In response to these complaints, on or about 30-AUG-2016, the patient presented to ophthalmologist, and on examination was found to have elevated left eye pressure, and a laser procedure was performed to reduce the left eye pressure. The patient continued to suffer from burning, light sensitivity, and reduced vision in his left eye. On 07-SEP-2016, the patient returned to ophthalmologist and was diagnosed as suffering from left eye zoster iridocyclitis. As a direct and proximate result of these malfunctions, the patient suffered painful injuries and damages, including partial blindness in his left eye, 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. Upon internal review, herpes zoster iridocyclitis and partial blindness in left eye were determined to be medically significant. Additional information has been requested.
Sex: M
Vaccine: VARZOS
Symptoms: Herpes zoster, Ophthalmic herpes zoster, Photophobia, Visual impairment
Clinical narrative: This initial spontaneous report was received from a lawyer regarding a case in litigation and refers to a male patient of unknown age. No information was provided regarding concomitant medications, concurrent conditions or medical history. On or about 16-APR-2013, the patient was inoculated with the ZOSTAVAX vaccine as recommended for routine health maintenance and for the prevention of shingles (dose, route, and lot # not provided). The vaccine did not prevent shingles but rather caused the patient to contract a persistent and severe strain of herpes zoster. After receiving the ZOSTAVAX vaccine (date not reported), the patient developed burning, pain, and light sensitivity in his left eye, accompanied by headaches. In response to these complaints, on or about 30-AUG-2016, the patient presented to ophthalmologist, and on examination was found to have elevated left eye pressure, and a laser procedure was performed to reduce the left eye pressure. The patient continued to suffer from burning, light sensitivity, and reduced vision in his left eye. On 07-SEP-2016, the patient returned to ophthalmologist and was diagnosed as suffering from left eye zoster iridocyclitis. As a direct and proximate result of these malfunctions, the patient suffered painful injuries and damages, including partial blindness in his left eye, 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. Upon internal review, herpes zoster iridocyclitis and partial blindness in left eye were determined to be medically significant. Additional information has been requested.
Sex: F
Vaccine: HPV4
Symptoms: Abnormal weight gain, Back pain, Blood test, Bronchial hyperreactivity, Chronic fatigue syndrome
Clinical narrative: This spontaneous prospective pregnancy report was received from a nurse and from a currently 19-year-old female patient, reporting on herself. Her concurrent condition included nausea. The patient did not have any pertinent medical history and had a drug allergy/reaction to BENADRYL. On an unknown date in 2010 (reported as "when she was 11"), the patient received her first dose of GARDASIL, 0.5 ml per intramuscular route with administration schedule of 0, 2 months and 6 months, for prevention of Human Papilloma Virus (HPV) (anatomical location, lot number and expiration date were not reported). On 17-JUN-2013, the patient was vaccinated with the second dose of GARDASIL. It was reported that the patient received her last GARDASIL on 10-DEC-2014. The patient's concomitant medications included ZOLOFT and unspecified anti-nausea medications. Since the administration of GARDASIL in 2010, the patient had suffered from a migraine that had not gone away, which was constant and not intermittent; the patient also developed chronic fatigue syndrome and passed out quite often for no apparent reason. The patient also reported that on an unknown date, her head swelled in certain areas and got hot, and she also had neck and back pain. On an unknown date, the patient was hospitalized for 5 days. The patient sought medical attention and several lab diagnostics and studies were performed, including blood panel, magnetic resonance imaging (MRI), computerized axial tomography (CAT) scan and "DAG" for migraines; however, the results were not reported. Furthermore, the patient could no longer work or go to school and could barely leave her house. (captured in MAARS # 1806USA004948). On an unknown date, the patient became pregnant. The last mentrual period (LMP) and estimated date of deliver (EDD) were not known and could not be calculated. The pregnancy outcome was pending. The fetal outcome was unknown. On an unknown date, the patient developed hyperemesis gravidarum. The nurse stated that the medical staff had only been seing the patient since 19-SEP-2017. The patient had a history of hospitalization for headache beginning 08-JUL-2017 (not further specified). They had been treating her for chronic fatigue, migraines, reactive airway disease, allergic rhinitis, abnormal weight gain (captured in MAARS # 1806USA004948). Treatment medications included ZOFRAN, clonazepam, sertraline and PRO-AIR (not further specified). The outcome of hyperemesis gravidarum and the causality assessment were not reported. Upon internal review, the event of hyperemesis gravidarum was determined to be medically significant. This is one of two reports regarding the same patient. Sender's Comments: US-009507513-1806USA004948.
Sex: F
Vaccine: HPV4
Symptoms: Computerised tomogram, Exposure during pregnancy, Feeling hot, Headache, Hyperemesis gravidarum
Clinical narrative: This spontaneous prospective pregnancy report was received from a nurse and from a currently 19-year-old female patient, reporting on herself. Her concurrent condition included nausea. The patient did not have any pertinent medical history and had a drug allergy/reaction to BENADRYL. On an unknown date in 2010 (reported as "when she was 11"), the patient received her first dose of GARDASIL, 0.5 ml per intramuscular route with administration schedule of 0, 2 months and 6 months, for prevention of Human Papilloma Virus (HPV) (anatomical location, lot number and expiration date were not reported). On 17-JUN-2013, the patient was vaccinated with the second dose of GARDASIL. It was reported that the patient received her last GARDASIL on 10-DEC-2014. The patient's concomitant medications included ZOLOFT and unspecified anti-nausea medications. Since the administration of GARDASIL in 2010, the patient had suffered from a migraine that had not gone away, which was constant and not intermittent; the patient also developed chronic fatigue syndrome and passed out quite often for no apparent reason. The patient also reported that on an unknown date, her head swelled in certain areas and got hot, and she also had neck and back pain. On an unknown date, the patient was hospitalized for 5 days. The patient sought medical attention and several lab diagnostics and studies were performed, including blood panel, magnetic resonance imaging (MRI), computerized axial tomography (CAT) scan and "DAG" for migraines; however, the results were not reported. Furthermore, the patient could no longer work or go to school and could barely leave her house. (captured in MAARS # 1806USA004948). On an unknown date, the patient became pregnant. The last mentrual period (LMP) and estimated date of deliver (EDD) were not known and could not be calculated. The pregnancy outcome was pending. The fetal outcome was unknown. On an unknown date, the patient developed hyperemesis gravidarum. The nurse stated that the medical staff had only been seing the patient since 19-SEP-2017. The patient had a history of hospitalization for headache beginning 08-JUL-2017 (not further specified). They had been treating her for chronic fatigue, migraines, reactive airway disease, allergic rhinitis, abnormal weight gain (captured in MAARS # 1806USA004948). Treatment medications included ZOFRAN, clonazepam, sertraline and PRO-AIR (not further specified). The outcome of hyperemesis gravidarum and the causality assessment were not reported. Upon internal review, the event of hyperemesis gravidarum was determined to be medically significant. This is one of two reports regarding the same patient. Sender's Comments: US-009507513-1806USA004948.
Sex: F
Vaccine: HPV4
Symptoms: Impaired work ability, Inappropriate schedule of drug administration, Laboratory test, Loss of consciousness, Loss of personal independence in daily activities
Clinical narrative: This spontaneous prospective pregnancy report was received from a nurse and from a currently 19-year-old female patient, reporting on herself. Her concurrent condition included nausea. The patient did not have any pertinent medical history and had a drug allergy/reaction to BENADRYL. On an unknown date in 2010 (reported as "when she was 11"), the patient received her first dose of GARDASIL, 0.5 ml per intramuscular route with administration schedule of 0, 2 months and 6 months, for prevention of Human Papilloma Virus (HPV) (anatomical location, lot number and expiration date were not reported). On 17-JUN-2013, the patient was vaccinated with the second dose of GARDASIL. It was reported that the patient received her last GARDASIL on 10-DEC-2014. The patient's concomitant medications included ZOLOFT and unspecified anti-nausea medications. Since the administration of GARDASIL in 2010, the patient had suffered from a migraine that had not gone away, which was constant and not intermittent; the patient also developed chronic fatigue syndrome and passed out quite often for no apparent reason. The patient also reported that on an unknown date, her head swelled in certain areas and got hot, and she also had neck and back pain. On an unknown date, the patient was hospitalized for 5 days. The patient sought medical attention and several lab diagnostics and studies were performed, including blood panel, magnetic resonance imaging (MRI), computerized axial tomography (CAT) scan and "DAG" for migraines; however, the results were not reported. Furthermore, the patient could no longer work or go to school and could barely leave her house. (captured in MAARS # 1806USA004948). On an unknown date, the patient became pregnant. The last mentrual period (LMP) and estimated date of deliver (EDD) were not known and could not be calculated. The pregnancy outcome was pending. The fetal outcome was unknown. On an unknown date, the patient developed hyperemesis gravidarum. The nurse stated that the medical staff had only been seing the patient since 19-SEP-2017. The patient had a history of hospitalization for headache beginning 08-JUL-2017 (not further specified). They had been treating her for chronic fatigue, migraines, reactive airway disease, allergic rhinitis, abnormal weight gain (captured in MAARS # 1806USA004948). Treatment medications included ZOFRAN, clonazepam, sertraline and PRO-AIR (not further specified). The outcome of hyperemesis gravidarum and the causality assessment were not reported. Upon internal review, the event of hyperemesis gravidarum was determined to be medically significant. This is one of two reports regarding the same patient. Sender's Comments: US-009507513-1806USA004948.
Sex: F
Vaccine: HPV4
Symptoms: Migraine, Neck pain, Nuclear magnetic resonance imaging, Rhinitis allergic, Swelling
Clinical narrative: This spontaneous prospective pregnancy report was received from a nurse and from a currently 19-year-old female patient, reporting on herself. Her concurrent condition included nausea. The patient did not have any pertinent medical history and had a drug allergy/reaction to BENADRYL. On an unknown date in 2010 (reported as "when she was 11"), the patient received her first dose of GARDASIL, 0.5 ml per intramuscular route with administration schedule of 0, 2 months and 6 months, for prevention of Human Papilloma Virus (HPV) (anatomical location, lot number and expiration date were not reported). On 17-JUN-2013, the patient was vaccinated with the second dose of GARDASIL. It was reported that the patient received her last GARDASIL on 10-DEC-2014. The patient's concomitant medications included ZOLOFT and unspecified anti-nausea medications. Since the administration of GARDASIL in 2010, the patient had suffered from a migraine that had not gone away, which was constant and not intermittent; the patient also developed chronic fatigue syndrome and passed out quite often for no apparent reason. The patient also reported that on an unknown date, her head swelled in certain areas and got hot, and she also had neck and back pain. On an unknown date, the patient was hospitalized for 5 days. The patient sought medical attention and several lab diagnostics and studies were performed, including blood panel, magnetic resonance imaging (MRI), computerized axial tomography (CAT) scan and "DAG" for migraines; however, the results were not reported. Furthermore, the patient could no longer work or go to school and could barely leave her house. (captured in MAARS # 1806USA004948). On an unknown date, the patient became pregnant. The last mentrual period (LMP) and estimated date of deliver (EDD) were not known and could not be calculated. The pregnancy outcome was pending. The fetal outcome was unknown. On an unknown date, the patient developed hyperemesis gravidarum. The nurse stated that the medical staff had only been seing the patient since 19-SEP-2017. The patient had a history of hospitalization for headache beginning 08-JUL-2017 (not further specified). They had been treating her for chronic fatigue, migraines, reactive airway disease, allergic rhinitis, abnormal weight gain (captured in MAARS # 1806USA004948). Treatment medications included ZOFRAN, clonazepam, sertraline and PRO-AIR (not further specified). The outcome of hyperemesis gravidarum and the causality assessment were not reported. Upon internal review, the event of hyperemesis gravidarum was determined to be medically significant. This is one of two reports regarding the same patient. Sender's Comments: US-009507513-1806USA004948.
Sex: F
Vaccine: VARZOS
Symptoms: Headache, Influenza like illness, Lethargy, Pyrexia
Clinical narrative: This case was reported by a consumer via call center representative and described the occurrence of headache in a female patient who received SHINGRIX for prophylaxis. On an unknown date, the patient received the 1st dose of SHINGRIX. On an unknown date, less than a year after receiving SHINGRIX, the patient experienced headache, fever, lethargy and influenza-like symptoms. On an unknown date, the outcome of the headache, fever, lethargy and influenza-like symptoms were unknown. It was unknown if the reporter considered the headache, fever, lethargy and influenza-like symptoms to be related to SHINGRIX. Additional details were provided as follows: The age at vaccination was not reported. The patient stated that he had the same normal symptoms after getting other vaccines. They were flu like symptoms. He did not want to provide any further information.
Age: 69.0
Sex: F
Vaccine: VARZOS
Symptoms: Pyrexia, Rash
Clinical narrative: This case was reported by a other health professional via call center representative and described the occurrence of rash in a 69-year-old female patient who received SHINGRIX (batch number ML532, expiry date 13th July 2020) for prophylaxis. On 7th August 2018, the patient received the 1st dose of SHINGRIX (intramuscular). On 7th August 2018, less than a day after receiving SHINGRIX, the patient experienced rash and fever. The patient was treated with methylprednisolone. On an unknown date, the outcome of the rash was recovering/resolving and the outcome of the fever was recovered/resolved. It was unknown if the reporter considered the rash and fever to be related to SHINGRIX. Additional details were provided as follows: The case was received by the Medical Technician. The patient received SHINGRIX in left arm. Within a few hours, the patient began to experience a rash on the whole left side of her body and a fever of 100 degree F. As treatment, the patient was prescribed Methylprednisolone. On 13th August 2018, the healthcare professional reported that the fever was resolved and the rash was improving but not resolved.
Age: 86.0
Sex: F
Vaccine: VARZOS
Symptoms: Fatigue, Muscular weakness, Myalgia, Nausea
Clinical narrative: This case was reported by a pharmacist via call center representative and described the occurrence of fatigue in a 86-year-old female patient who received SHINGRIX (batch number G933B, expiry date 22nd November 2020) for prophylaxis. On 10th August 2018, the patient received the 1st dose of SHINGRIX (intramuscular) .5 ml. On 10th August 2018, several hours after receiving SHINGRIX, the patient experienced fatigue, muscle weakness, nausea and muscle pain. On an unknown date, the outcome of the fatigue, muscle weakness, nausea and muscle pain were recovered/resolved. It was unknown if the reporter considered the fatigue, muscle weakness, nausea and muscle pain to be related to SHINGRIX. Additional details were provided as follows: The caller was a pharmacist called on behalf of a patient. Few hours after receiving SHINGRIX, the patient experienced fatigue, nausea, muscle aches and muscle weakness.
Sex: U
Vaccine: VARZOS
Symptoms: Herpes zoster
Clinical narrative: This case was reported by a other health professional via call center representative and described the occurrence of shingles in a adult patient who received SHINGRIX for prophylaxis. On an unknown date, the patient received the 1st dose of SHINGRIX. On an unknown date, less than a year after receiving SHINGRIX, the patient experienced shingles. On an unknown date, the outcome of the shingles was unknown. It was unknown if the reporter considered the shingles to be related to SHINGRIX. Additional details were reported as follows: The age group was not provided, but was selected adult as per the vaccine indication. The health care professional (HCP) reported that the patient developed shingles after receiving initial dose of SHINGRIX. No further details were available at the time of report.
Age: 68.0
Sex: F
Vaccine: VARZOS
Symptoms: Blister, Generalised erythema, Neuralgia, Pruritus generalised, Rash generalised
Clinical narrative: This case was reported by a pharmacist via call center representative and described the occurrence of generalized rash in a 68-year-old female patient who received SHINGRIX for prophylaxis. On 30th July 2018, the patient received the 1st dose of SHINGRIX (intramuscular) .5 ml. On an unknown date, less than a month after receiving SHINGRIX, the patient experienced generalized rash, generalized erythema, blister, generalized pruritus and nerve pain. In August 2018, the outcome of the generalized rash, generalized erythema, blister, generalized pruritus and nerve pain were recovered/resolved. It was unknown if the reporter considered the generalized rash, generalized erythema, blister, generalized pruritus and nerve pain to be related to SHINGRIX. Additional details were provided as follows: The patient received SHINGRIX in left arm. The patient experienced rash, nerve itching, nerve pain, redness and blisters on the left side of her body. The rash was described as approximately 2 inches long. The caller was unsure of when the symptoms were started, however, the symptoms lasted for approximately 2 weeks before going away.
Age: 69.0
Sex: M
Vaccine: VARZOS
Symptoms: Injection site pain
Clinical narrative: This case was reported by a pharmacist via call center representative and described the occurrence of injection site pain in a 69-year-old male patient who received SHINGRIX (batch number Y24KE, expiry date 11th October 2020) for prophylaxis. On 18th July 2018, the patient received the 2nd dose of SHINGRIX. On an unknown date, less than a month after receiving SHINGRIX, the patient experienced injection site pain. On an unknown date, the outcome of the injection site pain was not recovered/not resolved. It was unknown if the reporter considered the injection site pain to be related to SHINGRIX. Additional details were provided as follows: The patient received SHINGRIX in the left arm and experienced upper arm pain at site of injection that had not resolved and had actually gotten worse with time.
Age: 63.0
Sex: F
Vaccine: VARZOS
Symptoms: Chills, Diarrhoea, Headache, Nausea, Pyrexia
Clinical narrative: This case was reported by a consumer via call center representative and described the occurrence of headache in a 63-year-old female patient who received SHINGRIX for prophylaxis. On 13th August 2018, the patient received the 1st dose of SHINGRIX. In August 2018, less than a week after receiving SHINGRIX, the patient experienced headache, diarrhea, queasy, chills and fever. On an unknown date, the outcome of the headache, diarrhea, queasy, chills and fever were unknown. It was unknown if the reporter considered the headache, diarrhea, queasy, chills and fever to be related to SHINGRIX. Additional details were provided as follows: The reporter reported this case for herself. The patient experienced headache, chills, fever with body temperature of 99.2 degrees F, queasiness and diarrhea. The patient had denied permission to contact their physician.
Sex: U
Vaccine: VARZOS
Symptoms: Influenza like illness
Clinical narrative: This case was reported by a pharmacist via call center representative and described the occurrence of influenza-like symptoms in an unspecified number of adult patients who received SHINGRIX for prophylaxis. On an unknown date, the patient received SHINGRIX at an unknown dose. On an unknown date, less than a year after receiving SHINGRIX, the patient experienced influenza-like symptoms. On an unknown date, the outcome of the influenza-like symptoms was unknown. It was unknown if the reporter considered the influenza-like symptoms to be related to SHINGRIX. Additional details were provided as follows: The pharmacist reported that she had heard from other pharmacists that patients were reporting flu like symptoms with SHINGRIX. The symptoms were lasting for about a day.  No specific numbers or patient identifiers known. She was unaware if these events have been reported to GlaxoSmithKline by those pharmacists. This case has been linked with US2018147980, reported by the same reporter.
Age: 48.0
Sex: F
Vaccine: VARZOS, VARZOS
Symptoms: Drug administered to patient of inappropriate age, Herpes zoster, Inappropriate schedule of drug administration, Vaccination failure
Clinical narrative: This case was reported by a consumer via call center representative and described the occurrence of suspected vaccination failure in a 48-year-old female patient who received SHINGRIX for prophylaxis. Co-suspect products included SHINGRIX for prophylaxis. The patient's past medical history included shingles (several cases of Shingles including one in December 2017 which had shingles on her face, back and in her ear). On 27th April 2018, the patient received the 1st dose of SHINGRIX (intramuscular) .5 ml. On 20th June 2018, the patient received the 2nd dose of SHINGRIX. On 27th April 2018, unknown after receiving SHINGRIX and not applicable after receiving SHINGRIX, the patient experienced inappropriate age at vaccine administration. On 20th June 2018, the patient experienced inappropriate age at vaccine administration and drug dose administration interval too short. On 30th July 2018, 94 days after received the 1st dose of Shingrix and 40 days after received the 2nd dose of SHINGRIX, the patient experienced vaccination failure (serious criteria GSK medically significant) and shingles. The patient was treated with Valacyclovir. On an unknown date, the outcome of the vaccination failure, shingles, inappropriate age at vaccine administration, inappropriate age at vaccine administration and drug dose administration interval too short were unknown. It was unknown if the reporter considered the vaccination failure and shingles to be related to SHINGRIX and SHINGRIX. Additional details were provided as follows: Since the patient had several cases of Shingles, she started SHINGRIX vaccination. The patient received 1st and 2nd doses of SHINGRIX at 48 years age. Thus, the patient was under the indication age for getting SHINGRIX. This led to inappropriate age at vaccination for both doses. The patient also received the 2nd dose of SHINGRIX one week shy of two months, which led to shortening of vaccination schedule. This case was considered to be a suspected vaccination failure case, as the details regarding laboratory confirmation for shingles was unknown. The patient just finished her script of valacyclovir at the reporting time. The patient would submit a request for reimbursement. The contact detail of the physician was provided.
Sex: F
Vaccine: VARZOS
Symptoms: Arthropathy, Gait disturbance, Impaired driving ability, Mobility decreased, Muscular weakness
Clinical narrative: This case was reported by a consumer via call center representative and described the occurrence of lower extremities weakness of in a female patient who received SHINGRIX for prophylaxis. On an unknown date, the patient received the 2nd dose of SHINGRIX. On an unknown date, less than a year after receiving SHINGRIX, the patient experienced lower extremities weakness of, joint disorder, pain in arm, mobility decreased and walking difficulty. On an unknown date, the outcome of the lower extremities weakness of, joint disorder, pain in arm, mobility decreased and walking difficulty were unknown. It was unknown if the reporter considered the lower extremities weakness of, joint disorder, pain in arm, mobility decreased and walking difficulty to be related to SHINGRIX. Additional details were provided as follows: The age at the vaccination was not reported. The patient reported extreme weakness in legs, joints and left arm. The patient's left arm was also so painful and weak at times she could not use it. The patient had trouble driving or even lifting the arm up to her face. The patient walked regularly and had never had any muscle or joint problems before taking this vaccine, now it was a struggle to walk to the bathroom when she get out of bed or after sitting for a bit. The patient stated that something was wrong with this vaccine.
Sex: F
Vaccine: VARZOS
Symptoms: Pain in extremity
Clinical narrative: This case was reported by a consumer via call center representative and described the occurrence of lower extremities weakness of in a female patient who received SHINGRIX for prophylaxis. On an unknown date, the patient received the 2nd dose of SHINGRIX. On an unknown date, less than a year after receiving SHINGRIX, the patient experienced lower extremities weakness of, joint disorder, pain in arm, mobility decreased and walking difficulty. On an unknown date, the outcome of the lower extremities weakness of, joint disorder, pain in arm, mobility decreased and walking difficulty were unknown. It was unknown if the reporter considered the lower extremities weakness of, joint disorder, pain in arm, mobility decreased and walking difficulty to be related to SHINGRIX. Additional details were provided as follows: The age at the vaccination was not reported. The patient reported extreme weakness in legs, joints and left arm. The patient's left arm was also so painful and weak at times she could not use it. The patient had trouble driving or even lifting the arm up to her face. The patient walked regularly and had never had any muscle or joint problems before taking this vaccine, now it was a struggle to walk to the bathroom when she get out of bed or after sitting for a bit. The patient stated that something was wrong with this vaccine.
Sex: F
Vaccine: VARZOS
Symptoms: Injection site erythema, Injection site swelling
Clinical narrative: This case was reported by a nurse via sales rep and described the occurrence of injection site swelling in a 70-year-old female patient who received SHINGRIX for prophylaxis. On an unknown date, the patient received the 1st dose of SHINGRIX. On an unknown date, less than a year after receiving SHINGRIX, the patient experienced injection site swelling and injection site erythema. On an unknown date, the outcome of the injection site swelling and injection site erythema were recovered/resolved. It was unknown if the reporter considered the injection site swelling and injection site erythema to be related to SHINGRIX. Additional details were provided as follows: The age at vaccination was not reported. The patient received SHINGRIX on unknown deltoid. The patient reported redness and swelling around the injection site that covered most of the upper arm and lasted for 2 weeks. The reporter did not know when the reaction started in relation to the 1st dose of SHINGRIX or if the patient self treated the symptoms.
Age: 61.0
Sex: F
Vaccine: VARZOS
Symptoms: Herpes zoster, Pain, Pruritus, Rash, Scratch
Clinical narrative: case was reported by a consumer and described the occurrence of suspected vaccination failure in a female patient who received Shingrix for prophylaxis. Co-suspect products included Shingrix for prophylaxis. On 6th April 2018, the patient received the 1st dose of Shingrix. On 29th June 2018, the patient received the 2nd dose of Shingrix. On 3rd August 2018, 119 days after receiving Shingrix and 35 days after receiving Shingrix, the patient experienced vaccination failure (serious criteria GSK medically significant) and shingles. On an unknown date, less than year after receiving Shingrix, the patient experienced rash, scratch, skin discoloration and pain. The patient was treated with triamcinolone acetonide. On an unknown date, the outcome of the vaccination failure, shingles, rash, scratch, skin discoloration and pain were unknown. It was unknown if the reporter considered the vaccination failure, shingles, rash, scratch, skin discoloration and pain to be related to Shingrix and Shingrix. Additional details were provided as follows: The age at vaccination was not reported. In 2018, less than a year after vaccination, the patient had big rashes. She was black and blue from scratching them. The patient stated that, Shingrix did not worked and she was diagnosed with shingles on 3rd August 2018. The patient was in treatment. The physician prescribed her triamcinolone acetonide cream. The patient stated she was used to quality medicine. The patient had a college degree. This experience had cost her 500 dollars (including pain and suffering, writing the letter along with cost of pen, paper, envelope and stamp). This case was considered to be a suspected vaccination failure case, as the details regarding laboratory confirmation for shingles was unknown.
Age: 61.0
Sex: F
Vaccine: VARZOS
Symptoms: Skin discolouration, Vaccination failure
Clinical narrative: case was reported by a consumer and described the occurrence of suspected vaccination failure in a female patient who received Shingrix for prophylaxis. Co-suspect products included Shingrix for prophylaxis. On 6th April 2018, the patient received the 1st dose of Shingrix. On 29th June 2018, the patient received the 2nd dose of Shingrix. On 3rd August 2018, 119 days after receiving Shingrix and 35 days after receiving Shingrix, the patient experienced vaccination failure (serious criteria GSK medically significant) and shingles. On an unknown date, less than year after receiving Shingrix, the patient experienced rash, scratch, skin discoloration and pain. The patient was treated with triamcinolone acetonide. On an unknown date, the outcome of the vaccination failure, shingles, rash, scratch, skin discoloration and pain were unknown. It was unknown if the reporter considered the vaccination failure, shingles, rash, scratch, skin discoloration and pain to be related to Shingrix and Shingrix. Additional details were provided as follows: The age at vaccination was not reported. In 2018, less than a year after vaccination, the patient had big rashes. She was black and blue from scratching them. The patient stated that, Shingrix did not worked and she was diagnosed with shingles on 3rd August 2018. The patient was in treatment. The physician prescribed her triamcinolone acetonide cream. The patient stated she was used to quality medicine. The patient had a college degree. This experience had cost her 500 dollars (including pain and suffering, writing the letter along with cost of pen, paper, envelope and stamp). This case was considered to be a suspected vaccination failure case, as the details regarding laboratory confirmation for shingles was unknown.
Sex: M
Vaccine: FLU4
Symptoms: Autonomic nervous system imbalance, Disability, Loss of employment
Clinical narrative: This case was reported by a consumer via interactive digital media and described the occurrence of dysautonomia in a male patient who received Influenza vaccine Quadrivalent unspecified season for prophylaxis. On an unknown date, the patient received Influenza vaccine Quadrivalent unspecified season at an unknown dose. On an unknown date, 61 days after receiving Influenza vaccine Quadrivalent unspecified season, the patient experienced dysautonomia (serious criteria disability). On an unknown date, the outcome of the dysautonomia was unknown. It was unknown if the reporter considered the dysautonomia to be related to Influenza vaccine Quadrivalent unspecified season. Additional details were provided as follows: Two months after receiving flu vaccine, the patient was diagnosed as having dysautonomia. He lost his 90K a year job and was permanently disabled, physically and mentally for life. The patient stated he wished he never got vaccinated.
Age: 36.0
Sex: M
Vaccine: PPV, TDAP
Symptoms: Cardiac arrest, Death
Clinical narrative: This case was reported by a physician via sales rep and described the occurrence of cardiac arrest in a 37-year-old male patient who received BOOSTRIX for prophylaxis. Co-suspect products included PNEUMOVAX for prophylaxis. Concurrent medical conditions included HIV positive. In August 2018, the patient received BOOSTRIX and PNEUMOVAX. In August 2018, 10 hrs after receiving BOOSTRIX, the patient experienced cardiac arrest (serious criteria death and GSK medically significant). In August 2018, the outcome of the cardiac arrest was fatal. The patient died in August 2018. The reported cause of death was cardiac arrest. The reporter considered the cardiac arrest to be unrelated to BOOSTRIX. Additional information was received as follows: The reporter said that the event occurred about a week before the reporting date. Ten hours after vaccination, the patient was brought to the hospital in full cardiac arrest and he died. The reporter did not think to call GlaxoSmithKline. He did not think that either vaccine caused the death of the patient. The reporter agreed to be followed up and said the best way to contact was via email. Reported Cause(s) of Death: Cardiac arrest.