chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Sex: U
Vaccine: MMRV, VARCEL
Symptoms: Extra dose administered, No adverse event
Clinical narrative: This spontaneous report was received from a medical assistant referring to a patient of unknown age and gender. The patient's medical history and concurrent conditions were not provided. Concomitant therapies included sterile diluent. On 06-FEB-2019, the patient who was only supposed to receive a dose of PROQUAD (per subcutaneous route, lot# R002676; expiration date 15-JAN-2020 for prophylaxis) was also inadvertently administered a dose of VARIVAX (lot# R007695, expiration date 14-MAR-2020 for prophylaxis). The reporting medical assistant mentioned the error occurred because the provider who was administering the doses knew that the patient was due to be vaccinated for measles/mumps/rubella and varicella, but she did not notice that PROQUAD contains both, and essentially thinking that the dose of PROQUAD was a dose of M-M-R II), and therefore thought she needed to administer a dose of VARIVAX as well. No adverse effect reported. Lot Number R002676 is NOT valid for PROQUAD.
Sex: M
Vaccine: PPV
Symptoms: Extra dose administered, Wrong product administered
Clinical narrative: This spontaneous report was received from a nurse practitioner (also a regional director) via Pfizer (2017386685) refers to a male patient of unknown age. Patient's medical history, concurrent diseases and concomitant therapies were not reported. On 05-SEP-2017 the patient was vaccinated with PNEUMOVAX 23 one injection (dose, lot number, expiry date was not provided) for vaccination (immunization). On an unknown date, the patient also vaccinated with other suspect of PREVNAR 13 (lot number, expiry date was not provided). The reporter clarified that the patient already received 3 doses of vaccine. On 05-SEP-2017, the patient was administered PNEUMOVAX 23 instead of PREVNAR 13 (wrong product administered and interchange of vaccine products). The reporter considered that events reported in this case as Serious as medically significant.
Age: 0.67
Sex: U
Vaccine: RV5
Symptoms: No adverse event, Product storage error
Clinical narrative: This spontaneous report as received from a medical assistant refers to a 8 months old patient of unknown gender. The patient's concurrent conditions, medical history, concomitant medications, drug reactions and allergies were not reported. On 10-SEP-2018, the patient was vaccinated with improperly stored dose of ROTATEQ 2 ml tube, orally (lot # N029870, expiry date: 02-MAR-2019) for prophylaxis. The vaccine was exposed to the temperature of 32.21 degree Fahrenheit (°F) (32F to 35 F) and time frame was 3.5 hours from 06-SEP-2018. Previous excursion was 50.37 °F for 4.5 hours as recorded by a data logger. No adverse effect was reported. No product quality complaint was involved. This is one of the several reports received from the same reporter source. Sender's Comments: US-009507513-1809USA002868:Original Case : 1809USA002868, US-009507513-1902USA009323:Original Case : 1902USA009323, US-009507513-1902USA009325:Original Case : 1902USA009323, US-009507513-1902USA009326:Original Case : 1902USA009323.
Age: 14.0
Sex: F
Vaccine: HPV9
Symptoms: Full blood count, Injection site pain, Lymphadenopathy, Pain, X-ray normal
Clinical narrative: Information has been received from a nurse, concerning a currently 14 years old female patient. The patient's current condition included postural orthostatic tachycardia syndrome (POTS). Concomitant medications included propranolol 10 mg, 1 tablet bid, hydroxyzine for sleep issues and birth control pill. The patient had not known drug allergies. On 18-FEB-2019, the patient was vaccinated with the second dose of GARDASIL 9 intramuscular injection, lot number R024264 with expiration date 29-OCT-2019 for prevention human papilloma virus (HPV) (dose and anatomical location not reported). On 20-FEB-2019, the patient experienced swollen lymph nodes in the axilla of the injection arm, localized injection site pain and pain with movement of arm. On 21-FEB-2019, the patient went to the office and had an x-ray that was negative. A complete blood count was performed on the same date, and no results were provided. The patient still had injection site soreness on 21-FEB-2019. On an unspecified date, the patient received and unspecified treatment for the adverse events. The patient was not recovered from the adverse events at the time of this report.
Sex: F
Vaccine: VARZOS
Symptoms: Herpes zoster, Neuralgia, Pain, Rash, Skin lesion
Clinical narrative: Information has been received on 22-FEB-2019 from a lawyer regarding a case in litigation, involving a female patient, age and medical history not reported.  The patient was inoculated with ZOSTAVAX for routine health maintenance and for its intended purpose, the prevention of shingles (herpes zoster).  Shortly after receiving the vaccine, the patient suffered a rash on her scalp, neck and chest. The patient was diagnosed with shingles. Despite receiving treatment, the patient continued suffering rashes, lesions and shooting nerve pain. As a direct and proximate result of the ZOSTAVAX, the patients symptoms have resulted in physical limitations not present prior to the using the product. The patient also experiences mental and emotional distress due to physical limitations and the seriousness of his condition. The patient suffered serious, progressive, permanent and incurable injuries as well as significant conscious pain and suffering, mental anguish, emotional distress, loss of enjoyment of life, physical impairment, and injury. The patient required and will continue to require healthcare and services, medical and related expenses, and will continue to suffer mental anguish, physical pain and suffering, diminished capacity for the enjoyment of life, diminished quality of life and other losses and damages. Shingles and shooting nerve pain were considered to be disabling events. Additional information has been requested.
Sex: M
Vaccine: HPVX
Symptoms: Death
Clinical narrative: Information has been received from a consumer referring to a 13 years old male patient. Information about concurrent condition, concomitant medication, drug reactions/allergies and pertinent medical history was not provided. On an unknown date, the patient was vaccinated with unspecified HPV vaccine for prophylaxis. The reporter did not clarify which HPV vaccine brand, valent or manufacturer had been administered but a Merck vaccine could not be ruled out (product origin unknown). The reporter reported that on an unknown date in August 2018 the patient died after receiving the HPV vaccine. It was unknown if an autopsy was performed or not.  The causality between the event and the HPV vaccine was not reported.
Sex: U
Vaccine: VARCEL
Symptoms: Incorrect route of product administration, No adverse event
Clinical narrative: Information has been received from an office manager, concerning patient of unknown age and gender. The patient's medical history, concurrent conditions, previously drug reactions, allergies and concomitant medications were not provided. On 25-FEB-2019, the patient was vaccinated with VARIVAX injection, 0.5 ml/once intramuscularly, lot number R022115 with expiration date 02-AUG-2020 (strength and anatomical location were not reported) which was reconstituted with sterile diluent (manufacturer unknown) intramuscularly lot number M041089 with expiration date 10-JUN-2019 (formulation, strength, dose, frequency, indication, lot number and expiration date were not reported). No adverse effects were reported.
Sex: F
Vaccine: VARZOS
Symptoms: Herpes zoster
Clinical narrative: Information was received on 22-FEB-2019 from a lawyer regarding a case in litigation involving a female patient, history not provided. In 2014, at 65 years of age, the patient was prescribed ZOSTAVAX and it was administered by a pharmacist at a pharmacy for the long term prevention of shingles and zoster related conditions. The patient was treated by a physician at a hospital for the following injuries resulting from ZOSTAVAX use: shingles. Outcome of shingles was not reported.   Additional information has been requested.
Age: 61.0
Sex: F
Vaccine: VARZOS
Symptoms: Herpes zoster
Clinical narrative: Information has been received on 22-FEB-2019 regarding a case in litigation from a lawyer concerning a female patient of unknown age. There was no information provided regarding the patient's concurrent conditions, medical history or concomitant medications. The patient was prescribed the ZOSTAVAX by a healthcare provider for the long-term prevention of shingles and zoster-related conditions. On or about 24-DEC-2013, the patient was administered the ZOSTAVAX (lot number, expiration, dose and route unknown) by a physician at a physician's office. On an unknown date, the patient was treated by a healthcare provider at a physician's office for the following injuries resulting from the patient's ZOSTAVAX use: shingles. The patient claims damages as a result of injury to self, loss of services and economic losses. The outcome of the event was unknown. The causality of the event was considered to be related. Additional information has been requested.
Age: 60.0
Sex: F
Vaccine: VARZOS
Symptoms: Herpes zoster
Clinical narrative: Information has been received on 22-FEB-2019 regarding a case in litigation from a lawyer concerning a female patient of unknown age. There was no information provided regarding the patient's concurrent conditions, medical history or concomitant medications. The patient was prescribed the ZOSTAVAX by a healthcare provider for the long-term prevention of shingles and zoster-related conditions. In March 2016, the patient was administered the ZOSTAVAX (lot number, expiration, dose and route unknown) by a healthcare provider at a hospital. On an unknown date, the patient was treated by a healthcare provider at a hospital for the following injuries resulting from the patient's ZOSTAVAX use: shingles. The patient claims damages as a result of injury to self, loss of services and economic losses. The outcome of the event was unknown. The causality of the event was considered to be related. Additional information has been requested.
Sex: U
Vaccine: PPV
Symptoms: Adverse reaction
Clinical narrative: This spontaneous report as received from a pharmacist regarding unspecified number of patients of unknown age and gender. No information was provided regarding the patients medical history, concurrent conditions, previous drug reactions or concomitant medications. On an unknown date, the patients were vaccinated with PNEUMOVAX 23 (dosage, lot#, expiry date were not reported) for prophylaxis. On an unknown date, the patients experienced adverse reaction. The outcome of adverse reaction was unknown. Causality was not provided.
Sex: U
Vaccine: VARCEL
Symptoms: No adverse event, Product storage error
Clinical narrative: This spontaneous report as received from a nurse refers to a patient of unknown age and gender. The patient had unknown vaccination history and it could not be established if the patient was ever vaccinated with VARIVAX in the past. The patient's medical history included chickenpox. On an unknown date, titer was performed which showed the patient was not immune to varicella. On 25-FEB-2019, the patient was vaccinated with improperly stored dose of VARIVAX (exact dose and route of administration were not provided; lot # R023501, expiration date: 16-AUG-2020) reconstituted with properly stored diluent. The dose of the vaccine experienced temperature of -10.6 degrees Celsius for 1 hour and 44 minutes. There was no previous temperature excursion. Digital data logger was involved. No adverse events were reported.
Age: 53.0
Sex: F
Vaccine: VARZOS
Symptoms: Chills, Panic attack
Clinical narrative: This case was reported by a consumer via call center representative and described the occurrence of shivers in a 53-year-old female patient who received SHINGRIX for prophylaxis. Previously administered products included SHINGRIX (1st dose received on an unknown date). On 18th February 2019, the patient received the 2nd dose of SHINGRIX. On 19th February 2019, 1 days after receiving SHINGRIX, the patient experienced shivers and panic attack. On an unknown date, the outcome of the shivers and panic attack were unknown. It was unknown if the reporter considered the shivers and panic attack to be related to SHINGRIX. Additional details were provided as follows: The patient felt that she was about to having panic attack. The patient went to doctor without prescription, and stated that she did not see her doctor before. The reporter did give consent for follow up.
Sex: F
Vaccine: FLUX
Symptoms: Anaphylactic reaction
Clinical narrative: This case was reported by a nurse and described the occurrence of anaphylaxis in a female patient who received Flu unspecified for prophylaxis. The patient's past medical history included hysterectomy (In 1982), tubal ligation (In 1980), gallbladder operation (In 1987) and migraine (In December 2017). Concurrent medical conditions included hypertension, diabetes mellitus and drug allergy (Sulfa (Rash), Doxycycline (Sick), XOLAIR (Anaphylaxis)). On an unknown date, the patient received Flu vaccine. On an unknown date, unknown after receiving Flu vaccine, the patient experienced anaphylaxis (serious criteria GSK medically significant). On an unknown date, the outcome of the anaphylaxis was unknown. It was unknown if the reporter considered the anaphylaxis to be related to Flu vaccine. Additional details were provided as follows: The age at vaccination was not reported.
Age: 54.0
Sex: M
Vaccine: VARZOS
Symptoms: Chills, Pain, Pyrexia
Clinical narrative: This case was reported by a pharmacist via call center representative and described the occurrence of fever in a 54-year-old male patient who received SHINGRIX for prophylaxis. In May 2018, the patient received the 1st dose of SHINGRIX. On an unknown date, less than a year after receiving SHINGRIX, the patient experienced fever, chills and general body pain. On an unknown date, the outcome of the fever, chills and general body pain were recovered/resolved. It was unknown if the reporter considered the fever, chills and general body pain to be related to SHINGRIX. Additional details were provided as follows: The reporter was the patient's wife. The patient experienced fever, chills and body aches. The events were resolved after 2 days. The reported did not consent to follow up. For tolerance of 2nd dose of SHINGRIX refer linked case US2019032515.
Sex: U
Vaccine: VARZOS
Symptoms: Abdominal pain upper, Dizziness, Nausea, Pain in extremity
Clinical narrative: This case was reported by a physician via call center representative and described the occurrence of pain in arm in a adult patient who received SHINGRIX for prophylaxis. In February 2019, the patient received SHINGRIX. In February 2019, less than a week after receiving SHINGRIX, the patient experienced pain in arm, nausea, dizziness and stomach cramps. On an unknown date, the outcome of the pain in arm, nausea, dizziness and stomach cramps were not recovered/not resolved. It was unknown if the reporter considered the pain in arm, nausea, dizziness and stomach cramps to be related to SHINGRIX. Additional details were provided as follows: The age at vaccination was not reported. The physician stated that the patient received SHINGRIX vaccine 7 to 8 days before the date of reporting and still complained of sore arm, nausea, dizziness, and stomach cramps. No further details were provided at the time of this call.
Sex: F
Vaccine: VARZOS
Symptoms: Herpes zoster, Rash
Clinical narrative: This case was reported by a pharmacist via call center representative and described the occurrence of shingles in a female patient who received SHINGRIX for prophylaxis. On 12th February 2019, the patient received SHINGRIX. On 20th February 2019, 8 days after receiving SHINGRIX, the patient experienced shingles and rash. On an unknown date, the outcome of the shingles and rash were unknown. It was unknown if the reporter considered the shingles and rash to be related to SHINGRIX. Additional details were provided as follows: The age at vaccination was not reported. The patient had 4 small spots on her stomach near her bra line that the urgent care has identified as a Shingles outbreak.
Age: 63.0
Sex: M
Vaccine: VARZOS
Symptoms: Pruritus generalised
Clinical narrative: This case was reported by a consumer via call center representative and described the occurrence of generalized pruritus in a 63-year-old male patient who received SHINGRIX for prophylaxis. On 7th January 2019, the patient received the 1st dose of SHINGRIX (intramuscular). On an unknown date, less than a year after receiving SHINGRIX, the patient experienced generalized pruritus. On an unknown date, the outcome of the generalized pruritus was unknown. It was unknown if the reporter considered the generalized pruritus to be related to SHINGRIX. Additional details were provided as follows: The patient received SHINGRIX in left arm. The patient had been experiencing itching throughout the body at night from his back to stomach and to his legs. The patient did live in humid environment, so he thinks it might also be weather related. Did not consent to follow-up.
Sex: F
Vaccine: VARZOS
Symptoms: Rash generalised
Clinical narrative: This case was reported by a other health professional via call center representative and described the occurrence of generalized rash in a adult female patient who received SHINGRIX for prophylaxis. On an unknown date, the patient received the 1st dose of SHINGRIX. On an unknown date, 12 hrs after receiving SHINGRIX, the patient experienced generalized rash. On an unknown date, the outcome of the generalized rash was recovered/resolved. It was unknown if the reporter considered the generalized rash to be related to SHINGRIX. Additional details were provided as follows: The patient was between 55 to 66 years of age. The age at vaccination was not reported, but the patient was adult at the time of vaccination. Office manager said that one of their patients experienced rash all over her body from the  trunk and below about 12 hours after administration of the first dose of SHINGRIX. The rash lasted for over a week. The patient did not experience rash on her face.
Age: 77.0
Sex: F
Vaccine: VARZOS
Symptoms: Oral mucosal blistering, Stomatitis
Clinical narrative: This case was reported by a consumer via call center representative and described the occurrence of sores mouth in a 77-year-old female patient who received SHINGRIX for prophylaxis. On 3rd October 2018, the patient received the 1st dose of SHINGRIX (intramuscular). In October 2018, immediately after receiving SHINGRIX, the patient experienced sores mouth and blistering of mouth. On an unknown date, the outcome of the sores mouth and blistering of mouth were not recovered/not resolved. It was unknown if the reporter considered the sores mouth and blistering of mouth to be related to SHINGRIX. Additional details were provided as follows: The patient reported that shortly after receiving 1st dose, she had been experienced sores or blisters in her mouth. The reporter did not consent to follow up. For tolerance with 2nd dose of SHINGRIX, refer linked case US2019GSK036841.
Age: 67.0
Sex: F
Vaccine: VARZOS
Symptoms: Herpes zoster, Rash pustular
Clinical narrative: This case was reported by a consumer via call center representative and described the occurrence of shingles in a 67-year-old female patient who received SHINGRIX for prophylaxis. The patient's past medical history included shingles (received on an unknown date). Previously administered products included ZOVIRAX. Concomitant products included SHINGRIX. On 19th February 2019, the patient received the 2nd dose of SHINGRIX (intramuscular). On 19th February 2019, several hours after receiving SHINGRIX, the patient experienced shingles and pustule. On an unknown date, the outcome of the shingles and pustule were not recovered/not resolved. It was unknown if the reporter considered the shingles and pustule to be related to SHINGRIX. Additional details were provided as follows: The patient received the 1st dose of SHINGRIX in left arm on 16th December 2018. The patient received 2nd dose of SHINGRIX in left arm. The patient stated that she received the 2nd dose in the morning and later on that same evening, she noticed shingles on the back of her left thigh. The patient stated that her husband could see little pustules on the back of her thigh. The reporter consented to follow up.
Age: 63.0
Sex: F
Vaccine: VARZOS
Symptoms: Blood test normal, Nuclear magnetic resonance imaging normal, Vision blurred
Clinical narrative: This case was reported by a consumer via call center representative and described the occurrence of blurred vision in a 63-year-old female patient who received SHINGRIX for prophylaxis. In September 2018, the patient received the 1st dose of SHINGRIX (intramuscular) .5 ml. On an unknown date, several hours after receiving SHINGRIX, the patient experienced blurred vision. On an unknown date, the outcome of the blurred vision was recovered/resolved. It was unknown if the reporter considered the blurred vision to be related to SHINGRIX. Additional details were provided as follows: In the late afternoon, the patient received the dose of SHINGRIX in the right arm. The next morning after vaccination, at around 07:00 hours, the patient was driving to work and noticed that her vision was blurry. The patient determined that it was only her right eye that was blurry. At around 09:00 hours, the patient worked at her physician's office for checkup. The physician could not find anything, but send the patient to the emergency room. At 12:00 noon, the patient went to the emergency room and blood was taken, blood pressure was checked and had a magnetic resonance imaging (MRI). Everything came back to normal. The physician referred the patient to an eye specialist for the next day. At around 19:00 hours, the blurry vision was resolved. The next day, the patient went to the eye specialist and everything came back normal. The reported gave permission for her physician to be contacted. No more information was available.
Age: 55.0
Sex: M
Vaccine: VARZOS
Symptoms: Chills, Inappropriate schedule of product administration, Myalgia, Pain, Pain in extremity
Clinical narrative: This case was reported by a pharmacist via call center representative and described the occurrence of fever in a 55-year-old male patient who received SHINGRIX (batch number GL2HR, expiry date 22nd May 2021) for prophylaxis. Previously administered products included SHINGRIX with an associated reaction of pyrexia (also experienced chills and general body pain after 1st dose received in May 2018, refer linked case US2019GSK037063). On 20th February 2019, the patient received the 2nd dose of SHINGRIX. In February 2019, less than a week after receiving SHINGRIX, the patient experienced fever, chills, muscle pain, leg pain and general body pain. On 20th February 2019, the patient experienced drug dose administration interval too long. Rechallenge with SHINGRIX was positive. On an unknown date, the outcome of the fever, chills and leg pain were not recovered/not resolved and the outcome of the muscle pain, general body pain and drug dose administration interval too long were unknown. It was unknown if the reporter considered the fever, chills, muscle pain, leg pain and general body pain to be related to SHINGRIX. Additional details were provided as follows: The reporter was the patient's wife. The patient received the 2nd dose of SHINGRIX later than the recommended schedule, which led to lengthening of vaccination schedule. The patient experienced muscle aches, fever, chills and the patient founded it painful to sit. The patient was having body aches all over. The reporter did not consent to follow up.
Age: 55.0
Sex: M
Vaccine: VARZOS
Symptoms: Pyrexia, Vaccine positive rechallenge
Clinical narrative: This case was reported by a pharmacist via call center representative and described the occurrence of fever in a 55-year-old male patient who received SHINGRIX (batch number GL2HR, expiry date 22nd May 2021) for prophylaxis. Previously administered products included SHINGRIX with an associated reaction of pyrexia (also experienced chills and general body pain after 1st dose received in May 2018, refer linked case US2019GSK037063). On 20th February 2019, the patient received the 2nd dose of SHINGRIX. In February 2019, less than a week after receiving SHINGRIX, the patient experienced fever, chills, muscle pain, leg pain and general body pain. On 20th February 2019, the patient experienced drug dose administration interval too long. Rechallenge with SHINGRIX was positive. On an unknown date, the outcome of the fever, chills and leg pain were not recovered/not resolved and the outcome of the muscle pain, general body pain and drug dose administration interval too long were unknown. It was unknown if the reporter considered the fever, chills, muscle pain, leg pain and general body pain to be related to SHINGRIX. Additional details were provided as follows: The reporter was the patient's wife. The patient received the 2nd dose of SHINGRIX later than the recommended schedule, which led to lengthening of vaccination schedule. The patient experienced muscle aches, fever, chills and the patient founded it painful to sit. The patient was having body aches all over. The reporter did not consent to follow up.
Sex: M
Vaccine: VARZOS
Symptoms: Influenza like illness
Clinical narrative: This case was reported by a nurse via call center representative and described the occurrence of influenza-like symptoms in a male patient who received SHINGRIX for prophylaxis. On an unknown date, the patient received the 1st dose of SHINGRIX. On an unknown date, 6 hrs after receiving SHINGRIX, the patient experienced influenza-like symptoms. On an unknown date, the outcome of the influenza-like symptoms was recovered/resolved. It was unknown if the reporter considered the influenza-like symptoms to be related to SHINGRIX. Additional details were provided as follows: This case was reported by the patient's wife. The age at vaccination was not reported. The patient received SHINGRIX at 9 AM and by 3 PM on the same day, he had flu like symptoms, which resolved the next day. No other information was offered for this report. The reporter did not consent to follow up.
Sex: F
Vaccine: VARZOS
Symptoms: Injection site erythema, Injection site pruritus, Injection site reaction, Injection site swelling
Clinical narrative: This case was reported by a consumer via call center representative and described the occurrence of injection site reaction 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, unknown after receiving SHINGRIX, the patient experienced injection site reaction, erythema, swelling and pruritus. On an unknown date, the outcome of the injection site reaction, erythema, swelling and pruritus were unknown. It was unknown if the reporter considered the injection site reaction, erythema, swelling and pruritus to be related to SHINGRIX. Additional details were provided as follows: The age at vaccination was not reported. The reporter did not consent to follow up. This case has been linked to the case US2019032533, reported by the same reporter.
Sex: M
Vaccine: VARZOS
Symptoms: Injection site erythema, Injection site pruritus, Injection site reaction, Injection site swelling
Clinical narrative: This case was reported by a consumer via call center representative and described the occurrence of injection site reaction in a male patient who received SHINGRIX for prophylaxis. On an unknown date, the patient received the 1st dose of SHINGRIX. On an unknown date, unknown after receiving SHINGRIX, the patient experienced injection site reaction, erythema, swelling and pruritus. On an unknown date, the outcome of the injection site reaction, erythema, swelling and pruritus were unknown. It was unknown if the reporter considered the injection site reaction, erythema, swelling and pruritus to be related to SHINGRIX. Additional details were provided as follows: The reporter was the patient's wife. The age at vaccination was not reported. The reporter did not consent to follow up. This case has been linked to the case US2019032527, reported by the same reporter.
Age: 64.0
Sex: M
Vaccine: VARZOS, VARZOS
Symptoms: Metabolic encephalopathy, Seizure, Sepsis, Transaminases increased
Clinical narrative: This case was reported by a physician via call center representative and described the occurrence of sepsis in a 64-year-old male patient who received SHINGRIX for prophylaxis. Concurrent medical conditions included rheumatoid arthritis. Concomitant products included SHINGRIX, methotrexate and etanercept (Enbrel). On 28th January 2019, the patient received the 2nd dose of SHINGRIX (intramuscular). In February 2019, 14 days after receiving SHINGRIX, the patient experienced sepsis (serious criteria hospitalization, GSK medically significant and clinically significant/intervention required), seizure (serious criteria hospitalization, GSK medically significant and clinically significant/intervention required), transaminitis (serious criteria hospitalization and clinically significant/intervention required) and metabolic encephalopathy (serious criteria hospitalization, GSK medically significant and clinically significant/intervention required). The patient was treated with sulphamethoxazole, trimethoprim (Bactrim), levetiracetam (Keppra) and methylprednisolone sodium succinate (Solumedrol). On an unknown date, the outcome of the sepsis, seizure and metabolic encephalopathy were recovered/resolved and the outcome of the transaminitis was unknown.  It was unknown if the reporter considered the sepsis, transaminitis and metabolic encephalopathy to be related to SHINGRIX. The reporter considered the seizure to be related to SHINGRIX. Additional details were provided as follows: The age at vaccination was not reported but it could be 63 or 64 years. On 27th November 2018, the patient received 1st dose of SHINGRIX. The patient received both doses of SHINGRIX in the left deltoid. The batch number was not available at the time of reporting. Two weeks after the 2nd dose, the patient had an unexplained seizure. He was hospitalized from 13th February 2019 through 16th February 2019 where he received intravenous (IV) solumedrol and Bactrim, and was sent home on Keppra. The patient also had elevated transaminases and acute metabolic encephalopathy. At the hospital, the patient was informed the seizure was related to SHINGRIX. The primary diagnosis on paperwork notes was severe sepsis. The patient's physician attempted to determine causality or relation to SHINGRIX.
Age: 64.0
Sex: M
Vaccine: VARZOS, VARZOS
Symptoms: Encephalopathy, Foaming at mouth, Food poisoning, Glioma, Inappropriate schedule of product administration
Clinical narrative: This case was reported by a physician via call center representative and described the occurrence of sepsis in a 64-year-old male patient who received SHINGRIX for prophylaxis. Concurrent medical conditions included rheumatoid arthritis. Concomitant products included SHINGRIX, methotrexate and etanercept (Enbrel). On 28th January 2019, the patient received the 2nd dose of SHINGRIX (intramuscular). In February 2019, 14 days after receiving SHINGRIX, the patient experienced sepsis (serious criteria hospitalization, GSK medically significant and clinically significant/intervention required), seizure (serious criteria hospitalization, GSK medically significant and clinically significant/intervention required), transaminitis (serious criteria hospitalization and clinically significant/intervention required) and metabolic encephalopathy (serious criteria hospitalization, GSK medically significant and clinically significant/intervention required). The patient was treated with sulphamethoxazole, trimethoprim (Bactrim), levetiracetam (Keppra) and methylprednisolone sodium succinate (Solumedrol). On an unknown date, the outcome of the sepsis, seizure and metabolic encephalopathy were recovered/resolved and the outcome of the transaminitis was unknown.  It was unknown if the reporter considered the sepsis, transaminitis and metabolic encephalopathy to be related to SHINGRIX. The reporter considered the seizure to be related to SHINGRIX. Additional details were provided as follows: The age at vaccination was not reported but it could be 63 or 64 years. On 27th November 2018, the patient received 1st dose of SHINGRIX. The patient received both doses of SHINGRIX in the left deltoid. The batch number was not available at the time of reporting. Two weeks after the 2nd dose, the patient had an unexplained seizure. He was hospitalized from 13th February 2019 through 16th February 2019 where he received intravenous (IV) solumedrol and Bactrim, and was sent home on Keppra. The patient also had elevated transaminases and acute metabolic encephalopathy. At the hospital, the patient was informed the seizure was related to SHINGRIX. The primary diagnosis on paperwork notes was severe sepsis. The patient's physician attempted to determine causality or relation to SHINGRIX.
Age: 64.0
Sex: M
Vaccine: VARZOS, VARZOS
Symptoms: Loss of consciousness, Seizure
Clinical narrative: This case was reported by a physician via call center representative and described the occurrence of sepsis in a 64-year-old male patient who received SHINGRIX for prophylaxis. Concurrent medical conditions included rheumatoid arthritis. Concomitant products included SHINGRIX, methotrexate and etanercept (Enbrel). On 28th January 2019, the patient received the 2nd dose of SHINGRIX (intramuscular). In February 2019, 14 days after receiving SHINGRIX, the patient experienced sepsis (serious criteria hospitalization, GSK medically significant and clinically significant/intervention required), seizure (serious criteria hospitalization, GSK medically significant and clinically significant/intervention required), transaminitis (serious criteria hospitalization and clinically significant/intervention required) and metabolic encephalopathy (serious criteria hospitalization, GSK medically significant and clinically significant/intervention required). The patient was treated with sulphamethoxazole, trimethoprim (Bactrim), levetiracetam (Keppra) and methylprednisolone sodium succinate (Solumedrol). On an unknown date, the outcome of the sepsis, seizure and metabolic encephalopathy were recovered/resolved and the outcome of the transaminitis was unknown.  It was unknown if the reporter considered the sepsis, transaminitis and metabolic encephalopathy to be related to SHINGRIX. The reporter considered the seizure to be related to SHINGRIX. Additional details were provided as follows: The age at vaccination was not reported but it could be 63 or 64 years. On 27th November 2018, the patient received 1st dose of SHINGRIX. The patient received both doses of SHINGRIX in the left deltoid. The batch number was not available at the time of reporting. Two weeks after the 2nd dose, the patient had an unexplained seizure. He was hospitalized from 13th February 2019 through 16th February 2019 where he received intravenous (IV) solumedrol and Bactrim, and was sent home on Keppra. The patient also had elevated transaminases and acute metabolic encephalopathy. At the hospital, the patient was informed the seizure was related to SHINGRIX. The primary diagnosis on paperwork notes was severe sepsis. The patient's physician attempted to determine causality or relation to SHINGRIX.
Age: 0.25
Sex: F
Vaccine: DTAPIPVHIB, PNC13, RVX
Symptoms: Product preparation error, Product preparation issue
Clinical narrative: Initial information received on 18-Feb-2019 regarding an unsolicited valid non-serious case received from a Nurse. This case involves a three months (also reported as four months) old female patient who was vaccinated with a dose of PENTACEL, which was not reconstituted properly. The patient's past medical history, medical treatment(s), vaccination(s), concomitant medication(s) and family history were not provided. Concomitant vaccinations included PREVNAR 13 for Immunisation; and ROTAVIRUS VACCINE (ROTAVIRUS VACCINE) for Immunisation. On 14-Feb-2019, the patient received a 0.5 mL dose of suspect DIPHTHERIA/TETANUS/5 HYBRID AC PERTUSSIS/IPV(MRC5)/HIB(PRP/T) VACCINE (lot number: C5576AB and expiry date: 18-Oct-2019) (dose in series was not reported) via intramuscular route in the right thigh. It was a case of actual medication error due to inappropriate reconstitution technique as Pentacel had been diluted with regular saline and not the provided diluent. It was not reported if any adverse event occurred or not. 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 2001/83/EC 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. List of documents held by sender: none.
Sex: F
Vaccine: TDAP
Symptoms: Exposure during pregnancy, Inappropriate schedule of product administration, Off label use
Clinical narrative: Initial information received on 21-Feb-2019 regarding an unsolicited valid non-serious case received from other healthcare professional. This case involves female patient who was exposed to vaccine ADACEL during pregnancy. Data regarding this pregnancy were received prospectively, i.e. before pregnancy outcome was known. The vaccination occurred at unknown gestation period. The date of last menstrual period was not reported. The estimated due date was not reported. The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided. It was an actual medication error case due to inappropriate schedule of vaccine administered. It was also a case of off label use and vaccine exposure during pregnancy. It was reported that they have been vaccinating pregnant women each pregnancy even if it has been less time between vaccinations than what is recommended by the PI. Sometimes if they are pregnant back to back it could be 14 months from the last vaccination. It was unknown whether the patient had any adverse reactions. Additionally, at time of reporting, the outcome of the pregnancy was unknown. 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 2001/83/EC 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. List of documents held by sender: none.
Sex: M
Vaccine: TDAP
Symptoms: Incorrect route of product administration, Underdose
Clinical narrative: Initial information received on 22-Feb-2019 regarding an unsolicited valid non-serious case received from a nurse. This case involves a 47 years old male patient who received 0.25 ml dose of vaccine ADACEL intradermaly in the forearm. The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided. No concomitant therapy received. On 22-Feb-2019, the patient received a 0.25 ml dose of suspect DIPHTHERIA-2/TETANUS/5 AC PERTUSSIS VACCINE lot U5128AA via unknown route in the arm nos. It was a medication error case due to Incorrect route of product administration and vaccine underdose. It was unknown if adverse event was there. 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 2001/83/EC 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.
Sex: F
Vaccine: RAB
Symptoms: Inappropriate schedule of product administration
Clinical narrative: Initial information received on 22-Feb-2019 regarding an unsolicited valid non-serious case received from a nurse. This case involves a 18 years old female patient who Day 0 of vaccine IMOVAX RABIES on 05-Feb-2019 but the day 7 dose was given late, on day 17 (22-Feb-2019). The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided. On 05-Feb-2019, the patient received 1 ml of suspect RABIES (HDC) VACCINE lot NIK30 via intramuscular route in the left deltoid. On 22-Feb-2019 she also received 1 ml of the same vaccine lot NIK30 via intramuscular route in the right deltoid. It was a case of actual medication error due to Inappropriate schedule of vaccine administered. It was unknown of any adverse event. 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 2001/83/EC 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.
Sex: U
Vaccine: DTAP
Symptoms: Expired product administered
Clinical narrative: Initial information received on 22-Feb-2019 regarding an unsolicited valid non-serious case received from a other health professional. This case involves a 2 months old patient who received expired dose of vaccine DAPTACEL. The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided. Concomitant medications included ROTATEQ. On 22-Feb-2019, the patient received a 0.5 ml dose of suspect DIPHTHERIA-15/TETANUS/5 AC PERTUSSIS VACCINE lot C5148AA via unknown route. It was a case of actual medication error due to expired vaccine used. 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 2001/83/EC 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.
Sex: F
Vaccine: FLU4, MENB
Symptoms: No adverse event, Product storage error
Clinical narrative: Initial information received on 22-Feb-2019 regarding an unsolicited valid non-serious case received from a nurse. This case was linked to 2019SA056156 and 2019SA056122 (same reporter). This case involves a 18 years old female patient (also reported as 18 year 7 months) who received a 0.5ml single dose of vaccine FLUZONE QUADRIVALENT prefilled syringes batch number: LB549, expiry date- 30-Jun-2019 via intramuscular route in unknown administration site on 11-Jan-2019. The patients past medical history, medical treatment(s), vaccination(s) and family history were not provided. Concomitant medications included was TRUMENBA. It was an actual medication error due to incorrect product storage. (FLUZONE QUADRIVALENT had temperature excursion in Jan2019). No adverse event was reported. This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holders compliance with the requirements set out in Directive 2001/83/EC 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. Follow-up information received on 25-Feb-2019 regarding an unsolicited valid non-serious case received from a nurse. No new information was reported. List of documents held by sender: none.
Sex: U
Vaccine: HEPA, MNQ, TDAP
Symptoms: Product storage error
Clinical narrative: Initial information received on 25-Feb-2019 regarding an unsolicited valid non-serious case received from a other health professional. This case is linked to case SPGLZ9UY (same reporter). This case involves a 11 years old patient (gender unknown) who received vaccines ADACEL and MENACTRA, which were not stored properly. The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided. Concomitant medications included HAVRIX for Immunisation. On 28-Aug-2018, the patient received a dose  dose of suspect MENINGOCOCCAL A-C-Y-W135 (D CONJ) VACCINE lot U5751AA via intramuscular route in the left deltoid. On 28-Aug-2018, the patient received a dose  dose of suspect DIPHTHERIA-2/TETANUS/5 AC PERTUSSIS VACCINE lot 3552P via intramuscular route in the left deltoid. It was a case of actual medication error due to incorrect product storage. It was reported that there was a temperature excursion event involving MENACTRA and ADACEL that occurred between 16 Aug 2018 and 29Aug2018, duration unknown. Minimum temperature reached was 32 degrees Fahrenheit. The maximum temperatures were in range. 2 patients are known to have received affected MENACTRA and ADACEL products. It was not reported if the patient experienced any adverse event or not. 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 2001/83/EC 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.
Age: 3.0
Sex: F
Vaccine: FLU4
Symptoms: Ear pain, Injection site erythema, Injection site macule, Injection site warmth, Otitis media
Clinical narrative: The day after vaccination the patient's mother noticed a red spot developing. The next day she brought her daughter in to be seen and noted it was worse. When I saw her two days after the injection I noted: macular target appearing lesion to right bicep erythematous appx 2 inches with surrounding pink tones to skin appx 4 inches in diameter. Appeared as though pt did not feel pain or itching associated but it was warm to the touch as well.
Age: 73.0
Sex: F
Vaccine: VARZOS
Symptoms: Headache, Myalgia, Pyrexia, Tachycardia
Clinical narrative: Onset of fever 101 headache muscle aches and tachycardia approx 130 Ibuprofen 200 and tylenol     symptoms ended by 7 am.
Age: 50.0
Sex: M
Vaccine: VARZOS
Symptoms: Chills, Fatigue, Injection site erythema, Injection site pain, Injection site swelling
Clinical narrative: Pain, swelling and redness at the injection site, muscle aches, fever, shivering, chills, fatigue.
Age: 50.0
Sex: M
Vaccine: VARZOS
Symptoms: Myalgia, Pyrexia
Clinical narrative: Pain, swelling and redness at the injection site, muscle aches, fever, shivering, chills, fatigue.
Age: 56.0
Sex: F
Vaccine: VARZOS
Symptoms: Blepharospasm, Blood test, Dizziness, Drooling, Headache
Clinical narrative: Typical arm swelling, pain. Then muscles ache with spasms then big toe pain. Then drooling left lip with continuous eye twitching. Massive headaches with dizziness. Full body tingling on and off.
Age: 56.0
Sex: F
Vaccine: VARZOS
Symptoms: Muscle spasms, Myalgia, Pain in extremity, Paraesthesia, Peripheral swelling
Clinical narrative: Typical arm swelling, pain. Then muscles ache with spasms then big toe pain. Then drooling left lip with continuous eye twitching. Massive headaches with dizziness. Full body tingling on and off.