chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Sex: F
Vaccine: MMR
Symptoms: Antibody test negative
Clinical narrative: Information has been received from a currently 34 year old female pharmacist referring to herself. The patient was allergic to sulfa drugs. The patient's concomitant meditation and pertinent medical history were unknown. On an unknown date (reported as a child), the patient was vaccinated with M-M-R II (dose, route, lot number and expiration date unknown) for routine vaccination. Other suspect therapies included sterile diluent (MERCK). On an unknown date in "August of 2017", the patient had titers drawn while she was pregnant (Vaccine exposure before pregnancy) which showed she became no longer immune to MMR. The last menstrual period (LMP) and estimated date of delivery (EDD) were unknown. The pregnancy outcome was lost to f/u. There was no treatment given for the event and not seek medical attention. The outcome of no therapeutic response was reported as not recovered. The causality assessment was not provided by reporter.
Sex: M
Vaccine: VARZOS
Symptoms: Blister, Herpes zoster, Pain, Rash vesicular
Clinical narrative: Information has been received on 31-JUL-2018 regarding a case in litigation from a lawyer and a male consumer of unknown age. The patient's concurrent conditions, medical history and concomitant medications are unknown. On or about 24-JUL-2014, the patient was inoculated with ZOSTAVAX (lot number and expiration unknown) unknown route at a health care system as recommended for routine adult health maintenance for the prevention of shingles. The vaccine did not prevent shingles as intended, and the patient subsequently contracted a persistent strain of herpes zoster, also known as shingles. On or about 06-SEP-2016, the patient was treated at a health care system for a blistering vesicular outbreak, which was diagnosed as severe herpes zoster or shingles. The patient was prescribed valacyclovir for management of his painful symptoms and chronic pain. As a direct and proximate result of the ZOSTAVAX and/or despite receiving the ZOSTAVAX for long-term prevention of shingles, 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: 4.0
Sex: F
Vaccine: DTAPIPV, MMR, VARCEL
Symptoms: Injection site swelling, Injection site urticaria
Clinical narrative: This spontaneous report was received from a Registered Nurse referring to a 4 year old female patient. The patient had no pertinent medical history, concurrent conditions and concomitant medications and had no known previous drug reactions or allergies. On 30-JUL-2018, the patient was vaccinated with M-M-R II lot # N024702 and expiration date on 08-SEP-2019, subcutaneously in the left arm, as routine vaccination (dose was not provided); on the same date, the patient was additionally vaccinated with VARIVAX lot # R006221 with expiration date on 29-FEB-2018, in the right arm, for prophylaxis, (dose and route of administration were not reported); and with QUADRACEL in the left arm (dose, route of administration, indication, lot number and expiration date were not reported). On the same day, 30 minutes after vaccination, the patient experienced localized swelling and raised skin areas which appeared to be hives surrounding the injection site area on the left arm; the reporter mentioned that, as treatment the patient was administered BENADRYL and was sent to the emergency department for monitoring and was subsequently sent home. The outcome of injection site urticaria and injection site swelling was unknown and the causality assessment between M-M-R II and VARIVAX and the events was not reported.
Age: 15.0
Sex: F
Vaccine: HPV9
Symptoms: Nausea, Pyrexia
Clinical narrative: This spontaneous report was received from the patient's mother concerning a 15 year old non-pregnant female patient. The patient had no concurrent conditions, medical history, drug reactions/allergies or concomitant medications. On 30-JUL-2018 at around 16:30, the patient was vaccinated with the first dose of GARDASIL 9 0 .5 ml, via intramuscular, for prevention of HPV (Strength, lot # and expiration date were not reported). On the same day at around 20:00 (reported as around 20:00 or 20:30), she complained of nausea and had fever of 100.6 F degrees. On 31-JUL-2018 by 07:30, her fever had reached 103.6 F degrees and by 12:30 her fever reached 103.5 F degrees. She received an unspecified treatment for the events and no laboratory diagnostic tests were performed. However, she seek medical attention with her physician. The outcome of nausea and pyrexia was reported as not recovered. The causality between the events and GARDASIL 9 was not provided.
Age: 5.0
Sex: U
Vaccine: MMRV, MMRV
Symptoms: Circumstance or information capable of leading to medication error, No adverse event, Underdose
Clinical narrative: This spontaneous report was received from a registered nurse, and refers to a 5 year old patient of unknown gender. No information was provided regarding the patient's concurrent conditions, medical history or concomitant medications. On 31-JUL-2018, the patient was vaccinated with PROQUAD and sterile diluent (MERCK STERILE DILUENT) subcutaneosly, lot # R006216 with expiration date on 28-AUG-2018 for prophylaxis but pulled away during vaccination and did not receive full 0.5ml dose (final total dose was not reported). No adverse effect were reported.
Sex: M
Vaccine: HPV9
Symptoms: Inappropriate schedule of drug administration
Clinical narrative: This spontaneous report was received from a Nurse Practitioner referring to a 42 year old male patient. No information was provided regarding the patient's medical history, previous drug reactions, allergies, concurrent conditions or concomitant medications. On an unspecified date in July 2017 (reported as "13 months go"), the patient was vaccinated with the first dose of GARDASIL 9 for prophylaxis (dose, route of administration, anatomical location, lot number and expiration date were not reported); then, on 01-AUG-2018, the patient received the second dose of GARDASIL 9 lot number N028567 with expiration date on 17-MAY-2020, for prophylaxis (dose, route and anatomical location were unknown).
Sex: U
Vaccine: HIBV, RV5
Symptoms: No adverse event, Product storage error
Clinical narrative: This spontaneous report as received from a Registered Nurse referring to a patient of unknown age and gender. No information was provided regarding the patient's medical history, previous drug reactions, allergies, concurrent conditions or concomitant medications. On 31-JUL-2018, the patient was vaccinated with improperly stored PEDVAXHIB lot # M020100 with expiration date on 07-MAR-2019 for prophylaxis (dose, route of administration and anatomical location date were not reported), and with ROTATEQ by oral route lot # N022017 with expiration date on 10-MAR-2019 for prophylaxis (dose was unknown). The doses of PEDVAXHIB and ROTATEQ were exposed to a temperature excursion of 47 degrees Fahrenheit (°F) to 77 °F during a time frame of 14 minutes, which was detected by the data logger. There was no prior temperature excursion and no adverse events were reported.
Sex: F
Vaccine: VARZOS
Symptoms: Hypoaesthesia
Clinical narrative: This case was reported by a consumer via call center representative and described the occurrence of numbness in leg in a female patient who received SHINGRIX for prophylaxis. Previously administered products included ZOSTAVAX. On an unknown date, the patient received the 1st dose of SHINGRIX (intramuscular). On an unknown date, several hours after receiving SHINGRIX, the patient experienced numbness in leg. On an unknown date, the outcome of the numbness in leg was recovered/resolved. It was unknown if the reporter considered the numbness in leg to be related to SHINGRIX. Additional details were provided as follows: The age at vaccination was not reported. The patient got her dose of SHINGRIX in her left deltoid and the next morning about 5 am, she was awoke and her left leg was numb. The patient stated that she slept on her back and the numbness did resolve, but she was concerned if she would get the 2nd dose of SHINGRIX, could she have numbness again or worse, or loose the function of her leg all together. The patient had denied permission to contact their physician. The patient disconnected the call abruptly and was asked for name but declined. The patient noted she would be calling back to see if any other reports in 2 months. The patient disconnected before she could be told, GSK would not be able to provide that information. The patient was referred to her physician for discussion about 2nd dose. This case was linked with US2018131399, reported by same reporter for the patient's husband.
Sex: U
Vaccine: VARZOS
Symptoms: Herpes zoster
Clinical narrative: This case was reported by a other health professional via sales rep 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 information was received as follows: The case was reported by the pharma manager. The age group was not reported but was selected as adult as per vaccine indication. The patient developed shingles between the 1st and the 2nd dose of SHINGRIX. The GlaxoSmithKline account manager called into MI and stated that the pharmacy manager reported a SHINGRIX adverse event with a question to one of her colleagues.
Sex: F
Vaccine: VARZOS
Symptoms: Chills, Injection site erythema, Injection site swelling, Myalgia, Pyrexia
Clinical narrative: This case was reported by a pharmacist via call center representative and described the occurrence of injection site erythema in a female patient who received SHINGRIX (batch number Y24KE, expiry date 11th October 2020) for prophylaxis. On 20th July 2018, the patient received the 1st dose of SHINGRIX. On 20th July 2018, less than a day after receiving SHINGRIX, the patient experienced injection site erythema, muscle pain, chills, injection site swelling and fever. On an unknown date, the outcome of the injection site erythema and injection site swelling were not recovered/not resolved and the outcome of the muscle pain, chills and fever were recovered/resolved. The reporter considered the injection site erythema, muscle pain, chills, injection site swelling and fever to be probably related to SHINGRIX. Additional information was received as follows: The age at vaccination was not reported. The health care professional reported that at evening of the vaccination day, the reactions started to appear. The patient experienced redness, swelling at injection site and surrounding area. The patient also experienced fever, chills and muscle aches. All of the symptoms had resolved except the redness and swelling at the injection site. No additional information was provided.
Age: 59.0
Sex: M
Vaccine: VARZOS
Symptoms: Pyrexia
Clinical narrative: This case was reported by a physician via call center representative and described the occurrence of fever in a 59-year-old male patient who received SHINGRIX for prophylaxis. On 25th June 2018, the patient received the 1st dose of SHINGRIX. On 29th June 2018, 4 days after receiving SHINGRIX, the patient experienced fever. On an unknown date, the outcome of the fever was unknown. The reporter considered the fever to be possibly related to SHINGRIX. Additional details were provided as follows: The patient's body temperature was found as 103 degree F. The call transferred to MI (medical information).
Age: 69.0
Sex: F
Vaccine: VARZOS
Symptoms: Fatigue, Malaise, Myalgia, Pain
Clinical narrative: This case was reported by a consumer via call center representative and described the occurrence of muscle pain in a 69-year-old female patient who received SHINGRIX for prophylaxis. On 29th May 2018, the patient received the 1st dose of SHINGRIX (intramuscular). On 30th May 2018, 1 days after receiving SHINGRIX, the patient experienced muscle pain, general body pain, fatigue and feeling unwell. On an unknown date, the outcome of the muscle pain and fatigue were recovered/resolved and the outcome of the general body pain was not recovered/not resolved and the outcome of the feeling unwell was unknown. It was unknown if the reporter considered the muscle pain, general body pain, fatigue and feeling unwell to be related to SHINGRIX. Additional details were provided as follows: The patient experienced the events the morning after getting the vaccination, she did not feel well for approximately a week. The muscle aches were mostly in her shoulders and neck, she said that she still felt some tiny pinpricks of pain in various areas of her body at the time of reporting, the pain presents and then was gone quickly.
Age: 76.0
Sex: M
Vaccine: VARZOS
Symptoms: Chills, Hypersensitivity, Injection site pain, Pyrexia, Rash
Clinical narrative: This case was reported by a consumer via call center representative and described the occurrence of injection site pain in a 76-year-old male patient who received SHINGRIX for prophylaxis. On 16th July 2018, the patient received SHINGRIX .5 ml. On 16th July 2018, less than a day after receiving SHINGRIX, the patient experienced injection site pain, chills and fever. On 17th July 2018, the patient experienced hives and rash. On an unknown date, the patient experienced allergic reaction. The patient was treated with Steroid Cream. On an unknown date, the outcome of the injection site pain, chills and fever were recovered/resolved and the outcome of the hives and rash were recovering/resolving and the outcome of the allergic reaction was unknown. It was unknown if the reporter considered the injection site pain, chills, hives, rash, fever and allergic reaction to be related to SHINGRIX. Additional details were reported as follows: The patient received the vaccine in the left deltoid. The patient motioned that his arm was sore at the injection site but this went away quickly and that the evening of the shot he experienced fever then chills back and forth. The patient stated that the day after injection he developed a rash on his left forearm. The patient reported to his physician who prescribed a steroid cream and the physician stated that he felt that the patient was allergic to something in the SHINGRIX shot and advised him not to receive the second dose. The contact details of the physician was provided by the reporter.
Age: 76.0
Sex: M
Vaccine: VARZOS
Symptoms: Urticaria
Clinical narrative: This case was reported by a consumer via call center representative and described the occurrence of injection site pain in a 76-year-old male patient who received SHINGRIX for prophylaxis. On 16th July 2018, the patient received SHINGRIX .5 ml. On 16th July 2018, less than a day after receiving SHINGRIX, the patient experienced injection site pain, chills and fever. On 17th July 2018, the patient experienced hives and rash. On an unknown date, the patient experienced allergic reaction. The patient was treated with Steroid Cream. On an unknown date, the outcome of the injection site pain, chills and fever were recovered/resolved and the outcome of the hives and rash were recovering/resolving and the outcome of the allergic reaction was unknown. It was unknown if the reporter considered the injection site pain, chills, hives, rash, fever and allergic reaction to be related to SHINGRIX. Additional details were reported as follows: The patient received the vaccine in the left deltoid. The patient motioned that his arm was sore at the injection site but this went away quickly and that the evening of the shot he experienced fever then chills back and forth. The patient stated that the day after injection he developed a rash on his left forearm. The patient reported to his physician who prescribed a steroid cream and the physician stated that he felt that the patient was allergic to something in the SHINGRIX shot and advised him not to receive the second dose. The contact details of the physician was provided by the reporter.
Sex: F
Vaccine: VARZOS
Symptoms: Poor quality sleep
Clinical narrative: This case was reported by a consumer via call center representative and described the occurrence of poor sleep in a adult female patient who received SHINGRIX for prophylaxis. On an unknown date, the patient received the 1st dose of SHINGRIX (intramuscular). On an unknown date, less than a day after receiving SHINGRIX, the patient experienced poor sleep. On an unknown date, the outcome of the poor sleep was unknown. It was unknown if the reporter considered the poor sleep to be related to SHINGRIX. Additional details were provided as follows: The age at vaccination was not reported. The age group was not reported but was selected as adult as per vaccine indication. At 14:15 hours, the patient received SHINGRIX. The patient did not sleep well the night after receiving the SHINGRIX.
Sex: F
Vaccine: VARZOS
Symptoms: Chills, Pyrexia
Clinical narrative: This case was reported by a consumer via call center representative and described the occurrence of fever in a 75-year-old female patient who received SHINGRIX for prophylaxis. On 4th July 2018, the patient received the 1st dose of SHINGRIX (intramuscular) .5 ml. On 4th July 2018, less than a day after receiving SHINGRIX, the patient experienced fever and shivering. On 7th July 2018, the outcome of the fever and shivering were recovered/resolved. It was unknown if the reporter considered the fever and shivering to be related to SHINGRIX. Additional details were provided as follows: This case was reported by the patient's friend. The age at vaccination was not reported, but it could be 74 or 75 years. Limited information was provided. The patient experienced the above side effects.
Sex: M
Vaccine: VARZOS
Symptoms: Headache, Injection site irritation, Nausea, Pyrexia
Clinical narrative: This case was reported by a consumer via call center representative and described the occurrence of injection site irritation in a 70-year-old male patient 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 injection site irritation, headache, nausea and fever. On an unknown date, the outcome of the injection site irritation, headache, nausea and fever were recovered/resolved. It was unknown if the reporter considered the injection site irritation, headache, nausea and fever to be related to SHINGRIX. Additional details were reported as follows: The age at vaccination was not reported, but it could be 69 or 70 years old. The patient experienced symptoms which lasted for 5 days.
Sex: M
Vaccine: VARZOS
Symptoms: Influenza like illness, Injection site erythema, Injection site pain, Injection site swelling
Clinical narrative: This case was reported by a consumer via call center representative and described the occurrence of influenza-like symptoms in a male patient who received SHINGRIX for prophylaxis. Previously administered products included Influenza vaccine with an associated reaction of influenza like illness (over past 2 decades receiving Flu vaccine, refer case US2018GSK135676). On an unknown date, the patient received the 1st dose of SHINGRIX. On an unknown date, 1 day after receiving SHINGRIX, the patient experienced influenza-like symptoms, injection site swelling, injection site pain and injection site erythema. On an unknown date, the outcome of the influenza-like symptoms was recovered/resolved and the outcome of the injection site swelling, injection site pain and injection site erythema were unknown. It was unknown if the reporter considered the influenza-like symptoms, injection site swelling, injection site pain and injection site erythema to be related to SHINGRIX. Additional details were provided as follows: The age at vaccination was not reported. In the next morning of vaccination, the patient experienced flu-like symptoms. Less than a year after vaccination, the patient experienced redness, swelling and pain at the injection site. The patient did not provide any additional details. The patient did not wish to provide any contact information and ended the call before any additional details could be obtained.
Age: 57.0
Sex: F
Vaccine: VARZOS
Symptoms: Chills, Dizziness, Headache, Pain
Clinical narrative: This case was reported by a nurse via call center representative and described the occurrence of shivering in a 57-year-old female patient who received SHINGRIX for prophylaxis. On 24th July 2018, the patient received the 2nd dose of SHINGRIX. In July 2018, 8 hrs after receiving SHINGRIX, the patient experienced shivering, headache, dizziness and general body pain. On an unknown date, the outcome of the shivering, headache, dizziness and general body pain were unknown. It was unknown if the reporter considered the shivering, headache, dizziness and general body pain to be related to SHINGRIX. Additional details were provided as follows: This case was reported via chat. This case was reported by nurse for herself. About 8 hours after receiving the SHINGRIX vaccine, the patient experienced shivering, body aches, severe headache and dizziness. The healthcare professional did not have lot number or expiry date of the SHINGRIX.
Sex: M
Vaccine: HEP
Symptoms: Asthenia, Dizziness, Fatigue
Clinical narrative: This case was reported by a consumer via call center representative and described the occurrence of weakness in a adult male patient who received ENGERIX B adult for prophylaxis. Concurrent medical conditions included heart disorder. On 26th June 2018, the patient received the 1st dose of ENGERIX B adult. On an unknown date, less than a month after receiving ENGERIX B adult, the patient experienced weakness, dizziness and fatigue. In July 2018, the outcome of the weakness, dizziness and fatigue were recovered/resolved. It was unknown if the reporter considered the weakness, dizziness and fatigue to be related to ENGERIX B adult. Additional details were provided as follows: The age at vaccination was not reported. The patient experienced lightheadedness. At first, the patient said, he did not think the vaccine might have been the cause of the issues. He did have heart problems which could had some of the same symptoms. The patient could not remember how long after the injections that he started to realize there was a problem. He said that they did not go away quickly. The patient had to deal with them for about two weeks sometimes on a daily basis until the symptoms started to taper off. For tolerability after 2nd dose of SHINGRIX, refer case US2018GSK135695.
Age: 61.0
Sex: M
Vaccine: VARZOS
Symptoms: Chills, Headache, Pain, Pyrexia, Somnolence
Clinical narrative: This case was reported by a pharmacist via call center representative and described the occurrence of general body pain in a 61-year-old male patient who received SHINGRIX (batch number YE9YL, expiry date 6th February 2021) for prophylaxis. On 23rd July 2018, the patient received the 1st dose of SHINGRIX .5 ml. In July 2018, less than a week after receiving SHINGRIX, the patient experienced general body pain (serious criteria disability), chills (serious criteria disability), fever (serious criteria disability), headache (serious criteria disability) and sleepiness. On an unknown date, the outcome of the general body pain, chills, fever, headache and sleepiness were unknown. It was unknown if the reporter considered the general body pain, chills, fever, headache and sleepiness to be related to SHINGRIX. Additional details were provided as follows: The reporting pharmacist reported this case for himself. The patient received SHINGRIX in the left deltoid. The patient experienced whole-body achiness, and worst headache he ever had. The patient thought it was disabling because he slept the whole day and missed work.
Age: 69.0
Sex: F
Vaccine: VARZOS
Symptoms: Herpes zoster, Rash macular
Clinical narrative: This case was reported by a pharmacist via call center representative and described the occurrence of shingles in a 69-year-old female patient who received SHINGRIX (batch number ZG47A, expiry date 12th February 2021) for prophylaxis. On 20th April 2018, the patient received the 1st dose of SHINGRIX (intramuscular). On 22nd July 2018, 93 days after receiving SHINGRIX, the patient experienced shingles and erythromacular rash. On an unknown date, the patient experienced disease prodromal stage. On an unknown date, the outcome of the shingles, erythromacular rash and disease prodromal stage were unknown. It was unknown if the reporter considered the shingles, erythromacular rash and disease prodromal stage to be related to SHINGRIX. Additional details were provided as follows: On 22nd July 2018, prior to the second dose, the patient noticed 2 dots on her upper leg that looked like a bug bite, but at the time of reporting the patient thought that it was shingles. The shingles had not been officially diagnosed at the time of reporting. On 23rd July 2018, the patient received the 2nd dose of SHINGRIX. The patient had prodromal signs a couple days before the spots showed up and followed linear progression.
Age: 70.0
Sex: M
Vaccine: VARZOS
Symptoms: Blood glucose, Dizziness, Hyperhidrosis, Immediate post-injection reaction, Injection site pain
Clinical narrative: This case was reported by a pharmacist via call center representative and described the occurrence of loss of consciousness in a 70-year-old male patient who received SHINGRIX (batch number 37KL2, expiry date unknown) for prophylaxis. Concomitant products included SHINGRIX. On 17th July 2018, the patient received the 2nd dose of SHINGRIX .5 ml. On 17th July 2018, immediately after receiving SHINGRIX, the patient experienced loss of consciousness (serious criteria GSK medically significant), dizziness, sweating, injection site pain, pallor facial and arm discomfort. On 17th July 2018, the outcome of the loss of consciousness was recovered/resolved. On an unknown date, the outcome of the dizziness and sweating were recovered/resolved and the outcome of the injection site pain and arm discomfort were not recovered/not resolved and the outcome of the pallor facial was unknown. It was unknown if the reporter considered the loss of consciousness, dizziness, sweating, injection site pain, pallor facial and arm discomfort to be related to SHINGRIX. Additional details were provided as follows: The patient had a similar reaction to a vaccine when he was 4 or 5 years old. The patient did not know which vaccine. The patient had no history of seizures or anything similar. On 27th April 2018, the patient received 1st dose of SHINGRIX and did not experience adverse events. The patient received SHINGRIX on the left arm. The patient became dizzy and pale in the face immediately after getting the injection. The patient was also sweating all over his body. The pharmacist had to lie down him and he lost consciousness for 5 to 10 seconds. Emergency medical service (EMS) was called and arrived within minutes. The patient did not remember anything. He had not eaten anything that day. The EMS checked heart, glucose and blood pressure and readings were normal. The patient refused emergency room (ER) transport. Less than a day after vaccination, the patient also complained of pain in his left arm and that it was uncomfortable. The patient stayed in pharmacy for an additional 30 minutes after EMS departed and then left on his own. The pharmacist noted that a script for CELEBREX was called in on the answering machine from the ER when she arrived the next morning. It was unknown when he went to the ER. The pharmacist last spoke to the patient on 19th July 2018 and his arm was still uncomfortable but the patient was still planning to leave on a trip on 23rd July 2018.
Age: 70.0
Sex: M
Vaccine: VARZOS
Symptoms: Limb discomfort, Loss of consciousness, Pain in extremity, Pallor
Clinical narrative: This case was reported by a pharmacist via call center representative and described the occurrence of loss of consciousness in a 70-year-old male patient who received SHINGRIX (batch number 37KL2, expiry date unknown) for prophylaxis. Concomitant products included SHINGRIX. On 17th July 2018, the patient received the 2nd dose of SHINGRIX .5 ml. On 17th July 2018, immediately after receiving SHINGRIX, the patient experienced loss of consciousness (serious criteria GSK medically significant), dizziness, sweating, injection site pain, pallor facial and arm discomfort. On 17th July 2018, the outcome of the loss of consciousness was recovered/resolved. On an unknown date, the outcome of the dizziness and sweating were recovered/resolved and the outcome of the injection site pain and arm discomfort were not recovered/not resolved and the outcome of the pallor facial was unknown. It was unknown if the reporter considered the loss of consciousness, dizziness, sweating, injection site pain, pallor facial and arm discomfort to be related to SHINGRIX. Additional details were provided as follows: The patient had a similar reaction to a vaccine when he was 4 or 5 years old. The patient did not know which vaccine. The patient had no history of seizures or anything similar. On 27th April 2018, the patient received 1st dose of SHINGRIX and did not experience adverse events. The patient received SHINGRIX on the left arm. The patient became dizzy and pale in the face immediately after getting the injection. The patient was also sweating all over his body. The pharmacist had to lie down him and he lost consciousness for 5 to 10 seconds. Emergency medical service (EMS) was called and arrived within minutes. The patient did not remember anything. He had not eaten anything that day. The EMS checked heart, glucose and blood pressure and readings were normal. The patient refused emergency room (ER) transport. Less than a day after vaccination, the patient also complained of pain in his left arm and that it was uncomfortable. The patient stayed in pharmacy for an additional 30 minutes after EMS departed and then left on his own. The pharmacist noted that a script for CELEBREX was called in on the answering machine from the ER when she arrived the next morning. It was unknown when he went to the ER. The pharmacist last spoke to the patient on 19th July 2018 and his arm was still uncomfortable but the patient was still planning to leave on a trip on 23rd July 2018.
Age: 80.0
Sex: F
Vaccine: VARZOS
Symptoms: Dizziness, Fatigue, Insomnia, Malaise
Clinical narrative: This case was reported by a consumer via patient support programs and described the occurrence of sleeplessness in a 80-year-old female patient who received SHINGRIX for prophylaxis. On 18th July 2018, the patient received SHINGRIX .5 ml. In July 2018, less than a month after receiving SHINGRIX, the patient experienced feeling unwell. On 18th July 2018, the patient experienced sleeplessness. On 19th July 2018, the patient experienced exhaustion and dizziness. On an unknown date, the outcome of the sleeplessness, exhaustion, dizziness and feeling unwell were unknown. It was unknown if the reporter considered the sleeplessness, exhaustion, dizziness and feeling unwell to be related to SHINGRIX. Additional information was reported as follows: On the night of vaccination the patient was unable to sleep. The patient did not fall asleep until 5-6 am. The next day after the vaccination, the patient was exhausted. She felt dizzy and had to lie down and cancel her next appointment. After the vaccination, she felt terrible, did not feel well at all. The reporter wanted to speak with someone about the vaccination, if she decided not to take the 2nd dosage. No additional information was provided.
Sex: F
Vaccine: VARZOS
Symptoms: Chills, Hiatus hernia, Malaise, Pyrexia, Vomiting
Clinical narrative: This case was reported by a nurse via sales rep and described the occurrence of fever in a elderly female patient who received SHINGRIX (batch number 3AF9E, expiry date unknown) for prophylaxis. Concomitant products included SHINGRIX. On an unknown date, the patient received the 2nd dose of SHINGRIX .5 ml. On an unknown date, 9 hrs after receiving SHINGRIX, the patient experienced fever, chills, malaise and vomiting. On an unknown date, the outcome of the fever, chills, malaise and vomiting were unknown. It was unknown if the reporter considered the fever, chills, malaise and vomiting to be related to SHINGRIX. Additional details were provided as follows: The age at vaccination was not reported. On 23rd April 2018, the patient received 1st dose of SHINGRIX. At 9:00 am, the patient received 2nd dose of SHINGRIX on left deltoid. Approximately 9 hours after vaccination, the patient experienced feverish with chills, malaise and vomiting. The patient was seen in emergency room. The patient was discharged to home and no disposition received at this time. Reported believed that it could be related to use of the product. The batch number has been updated from 3AFPE to 3AF9E as per sales data sheet.
Age: 71.0
Sex: F
Vaccine: VARZOS
Symptoms: Erythema, Immediate post-injection reaction, Pain in extremity, Pyrexia
Clinical narrative: This case was reported by a consumer via call center representative and described the occurrence of pain in arm in a 71-year-old female patient who received SHINGRIX for prophylaxis. In March 2018, the patient received the 1st dose of SHINGRIX. On an unknown date, immediately after receiving SHINGRIX, the patient experienced pain in arm, erythema of extremities and fever. The patient was treated with ibuprofen. On an unknown date, the outcome of the pain in arm, erythema of extremities and fever were recovered/resolved. The reporter considered the pain in arm, erythema of extremities and fever to be almost certainly related to SHINGRIX. Additional details reported as follows: The age at vaccination was not reported. The patient experienced extreme soreness immediately after receiving the vaccination on right deltoid. The patient took Ibuprofen 800 mg and the pain subsided in 2 to 3 days. When the patient discontinued taking Ibuprofen, she unmasked a fever. The pain lasted a total of 7 to 10 days. The patient stated that she called previously to report her experience regarding the 1st dose anonymously. For tolerance after 2nd dose refer case US2018GSK137621.
Sex: M
Vaccine: RV1
Symptoms: Haemolytic uraemic syndrome, Polymerase chain reaction, Rotavirus infection, Vaccination failure, Viral infection
Clinical narrative: This case was reported by a nurse via other manufacturer and described the occurrence of vaccination failure in a male patient who received ROTARIX for prophylaxis. On an unknown date, the patient received ROTARIX (oral). On an unknown date, unknown after receiving ROTARIX, the patient experienced vaccination failure (serious criteria GSK medically significant), hemolytic uremic syndrome (serious criteria hospitalization and GSK medically significant), viral infection and rotavirus infection. On an unknown date, the outcome of the vaccination failure, hemolytic uremic syndrome, viral infection and rotavirus infection were unknown. It was unknown if the reporter considered the vaccination failure, hemolytic uremic syndrome, viral infection and rotavirus infection to be related to ROTARIX. Additional details were provided as follows: The case was reported by nurse practitioner who reported the case to other manufacturer. The age at the vaccination was not reported. The patient was previously vaccinated with ROTARIX on an unspecified date. The Lot number and expiration date was reported. The nurse practitioner reported to the employee that her son suffered a viral bout that caused hemolytic uremia in which her son was taken to a hospital. Months later the patient contracted rotavirus which was very concerning as the previous event with hemolytic uremia was a taxing event on his kidneys. On an unknown date, PCR testing (Polymerase chain reaction) was being conducted to determine the strain. Employee confirmed that he heard of this event on 17th July 2018. No further information was provided. This case was considered as the suspected vaccination failure case since the exact time to onset for the event and vaccination schedule were not reported. Lab Comments: Lab test performed on an unknown date.
Sex: M
Vaccine: VARZOS
Symptoms: Abdominal pain, Pancreatitis viral
Clinical narrative: This case was reported by a pharmacist via sales rep and described the occurrence of pancreatitis viral in a elderly male patient who received SHINGRIX for prophylaxis. On an unknown date, the patient received the 2nd dose of SHINGRIX .5 ml. On an unknown date, 7 days after receiving SHINGRIX, the patient experienced pancreatitis viral (serious criteria GSK medically significant) and abdominal pain. On an unknown date, the outcome of the pancreatitis viral and abdominal pain were unknown. The reporter considered the pancreatitis viral and abdominal pain to be unrelated to SHINGRIX. Additional details were provided as follows: The age at vaccination was not reported. One week following the dose of SHINGRIX, the patient complained of abdominal pain and visited his primary care physician. The patient was diagnosed with acute viral pancreatitis, which resulted without complications. The reporter did not think the illness was due to the vaccine. The reporter agreed to be contacted for follow up.
Age: 71.0
Sex: F
Vaccine: VARZOS
Symptoms: Chills, Diarrhoea, Dizziness, Erythema, Headache
Clinical narrative: This case was reported by a consumer via call center representative and described the occurrence of pain in arm in a 71-year-old female patient who received SHINGRIX (batch number YE9YL, expiry date unknown) for prophylaxis. Previously administered products included SHINGRIX with an associated reaction of pyrexia (1st dose received in March 2018, refer case US2018GSK133042). On 18th July 2018, the patient received the 2nd dose of SHINGRIX. In July 2018, less than a week after receiving SHINGRIX, the patient experienced erythema of extremities, dizziness, vomiting, diarrhea, fever, chills, headache and general body pain. On 18th July 2018, the patient experienced pain in arm. Rechallenge with SHINGRIX was positive. On 22nd July 2018, the outcome of the pain in arm, erythema of extremities, dizziness, vomiting, diarrhea, fever, chills, headache and general body pain were recovered/resolved. The reporter considered the pain in arm, erythema of extremities, dizziness, vomiting, diarrhea, fever, chills, headache and general body pain to be almost certainly related to SHINGRIX. Additional details reported as follows: The patient received SHINGRIX on right deltoid. The patient stated that immediately after vaccination her arm soreness was not as severe as the first SHINGRIX vaccination because of better administration. In July 2018, 12 hours after receiving SHINGRIX, the patient experienced dizziness, vomiting, diarrhea, fever, chills, headache and general body pain. The patient stated that she called previously to report her experience regarding the 1st dose anonymously.
Age: 71.0
Sex: F
Vaccine: VARZOS
Symptoms: Pain, Pain in extremity, Pyrexia, Vomiting
Clinical narrative: This case was reported by a consumer via call center representative and described the occurrence of pain in arm in a 71-year-old female patient who received SHINGRIX (batch number YE9YL, expiry date unknown) for prophylaxis. Previously administered products included SHINGRIX with an associated reaction of pyrexia (1st dose received in March 2018, refer case US2018GSK133042). On 18th July 2018, the patient received the 2nd dose of SHINGRIX. In July 2018, less than a week after receiving SHINGRIX, the patient experienced erythema of extremities, dizziness, vomiting, diarrhea, fever, chills, headache and general body pain. On 18th July 2018, the patient experienced pain in arm. Rechallenge with SHINGRIX was positive. On 22nd July 2018, the outcome of the pain in arm, erythema of extremities, dizziness, vomiting, diarrhea, fever, chills, headache and general body pain were recovered/resolved. The reporter considered the pain in arm, erythema of extremities, dizziness, vomiting, diarrhea, fever, chills, headache and general body pain to be almost certainly related to SHINGRIX. Additional details reported as follows: The patient received SHINGRIX on right deltoid. The patient stated that immediately after vaccination her arm soreness was not as severe as the first SHINGRIX vaccination because of better administration. In July 2018, 12 hours after receiving SHINGRIX, the patient experienced dizziness, vomiting, diarrhea, fever, chills, headache and general body pain. The patient stated that she called previously to report her experience regarding the 1st dose anonymously.
Age: 61.0
Sex: M
Vaccine: VARZOS
Symptoms: Arthralgia, Injection site erythema, Injection site pain, Limb discomfort, Pain in extremity
Clinical narrative: This case was reported by a consumer via call center representative and described the occurrence of coldness of lower extremities in a 61-year-old male patient who received SHINGRIX for prophylaxis. Concomitant products included SHINGRIX. On 19th July 2018, the patient received the 2nd dose of SHINGRIX .5 ml. In July 2018, less than a day after receiving SHINGRIX, the patient experienced coldness of lower extremities, leg discomfort, knee pain, pain in arm, injection site erythema and injection site pain. In July 2018, the outcome of the coldness of lower extremities, leg discomfort, knee pain, pain in arm and injection site erythema were recovered/resolved. On an unknown date, the outcome of the injection site pain was unknown. It was unknown if the reporter considered the coldness of lower extremities, leg discomfort, knee pain, pain in arm, injection site erythema and injection site pain to be related to SHINGRIX. Additional information was received as follows: The reporter mentioned that he experienced reactions within 24 hours after receiving the dose of SHINGRIX. The reporter stated that he woke up out of sleep and his lower extremities from the knees down to feet felt cold and had intermittent uncomfortable feelings. The reporter stated that he had pain in knees that he could feel when he climbed stairs and also had the pain at the injection site and redness as well, but added that the pain was not as bad as when he received the 1st dose of SHINGRIX. The coldness and uncomfortable feelings in his legs lasted through the night, and the pain in arm, pain in knees, and redness lasted for about 3 days. This case has been linked to the case US2018131388 (the patient's wife) and US2018086699 (same patient), reported by the same reporter.
Age: 61.0
Sex: M
Vaccine: VARZOS
Symptoms: Peripheral coldness
Clinical narrative: This case was reported by a consumer via call center representative and described the occurrence of coldness of lower extremities in a 61-year-old male patient who received SHINGRIX for prophylaxis. Concomitant products included SHINGRIX. On 19th July 2018, the patient received the 2nd dose of SHINGRIX .5 ml. In July 2018, less than a day after receiving SHINGRIX, the patient experienced coldness of lower extremities, leg discomfort, knee pain, pain in arm, injection site erythema and injection site pain. In July 2018, the outcome of the coldness of lower extremities, leg discomfort, knee pain, pain in arm and injection site erythema were recovered/resolved. On an unknown date, the outcome of the injection site pain was unknown. It was unknown if the reporter considered the coldness of lower extremities, leg discomfort, knee pain, pain in arm, injection site erythema and injection site pain to be related to SHINGRIX. Additional information was received as follows: The reporter mentioned that he experienced reactions within 24 hours after receiving the dose of SHINGRIX. The reporter stated that he woke up out of sleep and his lower extremities from the knees down to feet felt cold and had intermittent uncomfortable feelings. The reporter stated that he had pain in knees that he could feel when he climbed stairs and also had the pain at the injection site and redness as well, but added that the pain was not as bad as when he received the 1st dose of SHINGRIX. The coldness and uncomfortable feelings in his legs lasted through the night, and the pain in arm, pain in knees, and redness lasted for about 3 days. This case has been linked to the case US2018131388 (the patient's wife) and US2018086699 (same patient), reported by the same reporter.
Sex: F
Vaccine: VARZOS
Symptoms: Therapeutic response unexpected
Clinical narrative: This case was reported by a consumer via call center representative and described the occurrence of unexpected therapeutic effect in a female patient who received SHINGRIX for prophylaxis. The patient's past medical history included neuropathy peripheral (peripheral neuropathy on the suboccipital neuralgia), pneumonia and shingles. Previously administered products included antidepressant, opioids, calcium channel drugs and SHINGRIX with an associated reaction of therapeutic response unexpected (refer case: US2018131406). Concurrent medical conditions included pain. 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 unexpected therapeutic effect. On an unknown date, the outcome of the unexpected therapeutic effect was unknown. It was unknown if the reporter considered the unexpected therapeutic effect to be related to SHINGRIX. Additional details were provided as follows: This case was reported by the patient's father. The age at vaccination was not reported. The patient had pneumonia and all the sudden she started having Peripheral Neuropathy (PHN) on the suboccipital neuralgia. Investigating physician was suspecting that it was PHN related to the shingles. Even though the patient did not get a rash, physician believes she had symptoms that were related to PHN due to shingles. At the time of this report, the physician was investigating the cause. The patient had been on opioids, antidepressant, calcium channel drugs and all sort of drugs to treat her pain and the reporter had been struggling with that for 5 years. The patient had SHINGRIX injection three months afterwards from the 1st dose of SHINGRIX and the patient's pain went away for full 48 hours. And then it came back. The reporter wanted to let the company know, that it could be worth investigating using SHINGRIX vaccine for other indications. This case has been linked to the US2018131406, reported by the same reporter.
Age: 58.0
Sex: F
Vaccine: VARZOS
Symptoms: Abdominal discomfort, Diarrhoea, Headache, Injection site pain, Lethargy
Clinical narrative: Lower digestive upset and loose stools 3:30 am; Mild nausea 3:30 am-12 pm; Headache 6 am - 6 pm (resolved 6 pm with acetaminophen); Lethargy 6 am - 6 am next day; Muscle pain at vaccine site (continuing 36 hrs post-shot).
Age: 58.0
Sex: F
Vaccine: VARZOS
Symptoms: Nausea
Clinical narrative: Lower digestive upset and loose stools 3:30 am; Mild nausea 3:30 am-12 pm; Headache 6 am - 6 pm (resolved 6 pm with acetaminophen); Lethargy 6 am - 6 am next day; Muscle pain at vaccine site (continuing 36 hrs post-shot).
Age: 2.0
Sex: F
Vaccine: HEPA
Symptoms: Incorrect dose administered
Clinical narrative: Patient given Adult Hep A vaccine instead of pediatric dose.
Age: 68.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site erythema, Injection site pain, Injection site swelling, Injection site warmth, Local reaction
Clinical narrative: Localized skin reaction to left deltoid where injection was given. Area red warm swollen and tender.
Age: 68.0
Sex: F
Vaccine: VARZOS
Symptoms: Skin reaction
Clinical narrative: Localized skin reaction to left deltoid where injection was given. Area red warm swollen and tender.
Age: 19.0
Sex: F
Vaccine: VARCEL
Symptoms: Injection site erythema, Injection site reaction, Injection site swelling, Urticaria
Clinical narrative: Patient had a welt at the injection site the size of a nickel on 07/31/2018, at 7 p.m. At 11:00 a.m. on 8/1/218 the welt was the size of a baseball. Raised red bump, not warm to the touch. Patient able to move arm without difficulty. Denies SOB, trouble breathing, or swallowing.