chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 61.0
Sex: F
Vaccine: COVID19
Symptoms: Blood pressure measurement, Dyspnoea, Heart rate, Nausea, Paraesthesia
Clinical narrative: Seizure; Dyspnoea; Nausea; Paraesthesia; Somnolence; This case was received via FDA VAERS on 18-May-2021 and was forwarded to Moderna on 18-May-2021.    This regulatory authority case was reported by an other health care professional (subsequently medically confirmed) and describes the occurrence of SEIZURE (Seizure) in a 61-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 003A21A) for COVID-19 immunization. The occurrence of additional non-serious events is detailed below.     Concurrent medical conditions included Seizure.    On 06-Mar-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 06-Mar-2021, the patient experienced SEIZURE (Seizure) (seriousness criterion medically significant), DYSPNOEA (Dyspnoea), NAUSEA (Nausea), PARAESTHESIA (Paraesthesia) and SOMNOLENCE (Somnolence). At the time of the report, SEIZURE (Seizure), DYSPNOEA (Dyspnoea), NAUSEA (Nausea), PARAESTHESIA (Paraesthesia) and SOMNOLENCE (Somnolence) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, Blood pressure measurement: 100/60 mmHg (Inconclusive) decreased. On an unknown date, Heart rate: 76 (normal) normal.     For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   The patient is taking unknown medicines for the seizures.; Sender's Comments: Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded.
Age: 61.0
Sex: F
Vaccine: COVID19
Symptoms: Seizure, Somnolence
Clinical narrative: Seizure; Dyspnoea; Nausea; Paraesthesia; Somnolence; This case was received via FDA VAERS on 18-May-2021 and was forwarded to Moderna on 18-May-2021.    This regulatory authority case was reported by an other health care professional (subsequently medically confirmed) and describes the occurrence of SEIZURE (Seizure) in a 61-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 003A21A) for COVID-19 immunization. The occurrence of additional non-serious events is detailed below.     Concurrent medical conditions included Seizure.    On 06-Mar-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 06-Mar-2021, the patient experienced SEIZURE (Seizure) (seriousness criterion medically significant), DYSPNOEA (Dyspnoea), NAUSEA (Nausea), PARAESTHESIA (Paraesthesia) and SOMNOLENCE (Somnolence). At the time of the report, SEIZURE (Seizure), DYSPNOEA (Dyspnoea), NAUSEA (Nausea), PARAESTHESIA (Paraesthesia) and SOMNOLENCE (Somnolence) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, Blood pressure measurement: 100/60 mmHg (Inconclusive) decreased. On an unknown date, Heart rate: 76 (normal) normal.     For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   The patient is taking unknown medicines for the seizures.; Sender's Comments: Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded.
Age: 92.0
Sex: M
Vaccine: COVID19
Symptoms: Death
Clinical narrative: Death; This case was received via VAERS on 18-May-2021 and was forwarded to Moderna on 18-May-2021.    This regulatory authority case was reported by an other health care professional and describes the occurrence of DEATH (Death) in a 92-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 13L20A) for COVID-19 vaccination.     No Medical History information was reported.    On 14-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. Death occurred on 10-Feb-2021 The patient died on 10-Feb-2021. The cause of death was not reported. It is unknown if an autopsy was performed.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   Concomitant product use was not provided.  It was reported that Patient had no scanned records on file and no further noted regarding events from this time to date of death. No autopsy results were available. 27 days from date of vaccine to date of death.  Treatment information was not provided.   Action taken with mRNA-1273 in response to the event was not applicable.  Very limited information regarding this event has been provided at this time.  Further information cannot be requested.; Sender's Comments: Very limited information regarding this event has been provided at this time.  Further information cannot be requested.; Reported Cause(s) of Death: Unknown cause of death
Sex: U
Vaccine: VARZOS, VARZOS
Symptoms: Herpes zoster, Vaccination failure
Clinical narrative: had the shots/ had Shingles 3 times, suspected vaccination failure; had Shingles 3 times; This case was reported by a consumer via media and described the occurrence of suspected vaccination failure in a patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   Co-suspect products included Herpes zoster (Shingles vaccine) for prophylaxis.   On an unknown date, the patient received the 1st dose of Shingles vaccine and the 2nd dose of Shingles vaccine. On an unknown date, unknown after receiving Shingles vaccine and Shingles vaccine, the patient experienced vaccination failure (serious criteria GSK medically significant) and shingles. On an unknown date, the outcome of the vaccination failure and shingles were unknown.   It was unknown if the reporter considered the vaccination failure and shingles to be related to Shingles vaccine and Shingles vaccine.  Additional details were provided as follows:  The case was reported by the patient for himself/herself. The age at vaccination was not reported.  The patient got vaccinated with the Shingles shots but also experienced shingles 3 times.  This case was considered as suspected vaccination failure, as details regarding completion of primary vaccination schedule, laboratory test confirmation for shingles infection and time to event onset were unknown.
Sex: U
Vaccine: VARZOS
Symptoms: Herpes zoster, Vaccination failure
Clinical narrative: I got the shot then got shingles/Suspected vaccination failure; shingles; This case was reported by a consumer via media and described the occurrence of suspected vaccination failure in a patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   On an unknown date, the patient received Shingles vaccine. On an unknown date, unknown after receiving Shingles vaccine, the patient experienced vaccination failure (serious criteria GSK medically significant) and shingles. On an unknown date, the outcome of the vaccination failure and shingles were unknown.   It was unknown if the reporter considered the vaccination failure and shingles to be related to Shingles vaccine.  Additional details were reported as follows: This case was reported by patient himself/herself. The age at vaccination was not reported. The patient received Shingles vaccine and then got shingles. The patient stated that it was not painful. This case was considered as suspected vaccination failure as details regarding completion of primary vaccination schedule, time to onset and laboratory test confirming herpes zoster were unknown at the time of reporting. The follow-up would not possible as no contact details were available.
Sex: U
Vaccine: VARZOS, VARZOS
Symptoms: Blindness unilateral, Corneal disorder, Herpes zoster, Ophthalmic herpes zoster, Vaccination failure
Clinical narrative: now I'm losing the cornea and cant see out of it.; now I'm losing the cornea and cant see out of it.; I've had shingles four times and had all the shots, they do mot work for me/ Suspected vaccination failure; I had them in my right cornea in November of last year and that was a transplanted cornea and now I'm losing the cornea and cant see out of it.; This case was reported by a consumer and described the occurrence of vaccination failure in a patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   Co-suspect products included Herpes zoster (Shingles vaccine) for prophylaxis.   The patient's past medical history included shingles (had four times) and corneal transplant.   On an unknown date, the patient received the 2nd dose of Shingles vaccine and the 1st dose of Shingles vaccine. In November 2020, unknown after receiving Shingles vaccine and Shingles vaccine, the patient experienced vaccination failure (serious criteria GSK medically significant) and ophthalmic herpes zoster (serious criteria GSK medically significant). On an unknown date, the patient experienced unilateral blindness (serious criteria GSK medically significant) and corneal disorder. On an unknown date, the outcome of the vaccination failure and ophthalmic herpes zoster were unknown and the outcome of the unilateral blindness and corneal disorder were not recovered/not resolved.   It was unknown if the reporter considered the vaccination failure, ophthalmic herpes zoster, unilateral blindness and corneal disorder to be related to Shingles vaccine and Shingles vaccine.  Additional details were reported as follows: This case was reported by patient himself/herself. The age at vaccination was not reported. The patient received all the doses of Shingles vaccine and they did not work for him/her. The patient stated that he/she had shingles in his/her right cornea and that was a transplanted cornea and at the time of reporting, he/she was losing the cornea and could not see out of it. This case was considered as suspected vaccination failure as details regarding time to onset and laboratory test confirming herpes zoster were unknown at the time of reporting. The follow-up would not possible as no contact details were available.
Sex: U
Vaccine: VARZOS
Symptoms: Fatigue, Nausea, Pain
Clinical narrative: very tired; achy; somewhat nauseated; This case was reported by a consumer via (Shingrix GSK Chatbot) interactive digital media and described the occurrence of tiredness in a patient who received Herpes zoster (Shingrix) for prophylaxis.   On 24th May 2021, the patient received the 2nd dose of Shingrix. On 25th May 2021, 1 days after receiving Shingrix, the patient experienced tiredness, pain and nausea. On an unknown date, the outcome of the tiredness, pain and nausea were not recovered/not resolved.   It was unknown if the reporter considered the tiredness, pain and nausea to be related to Shingrix.  Additional details were reported as follows: The case was reported by the patient. The age at vaccination was not reported. The patient received 2nd dose of Shingrix one day prior to the report and on the day of reporting, the patient was very tired, achy and somewhat nauseated. The patient was resting now and inquired that besides rest what was best for the pain. The follow up would not be possible as no contact details were available.
Sex: U
Vaccine: VARZOS
Symptoms: Headache, Myalgia, Night sweats, Pyrexia
Clinical narrative: fever; woke up in sweats; headache; muscle pains; This case was reported by a consumer via call center representative and described the occurrence of fever in a patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   Previously administered products included Shingles vaccine with an associated reaction of no adverse event (received first shingle vaccine months ago on an unknown date with no side effect).   On 25th May 2021, the patient received the 2nd dose of Shingles vaccine. In May 2021, 1 day after receiving Shingles vaccine, the patient experienced fever, night sweat, headache and muscle pain. On an unknown date, the outcome of the fever, night sweat, headache and muscle pain were not recovered/not resolved.   It was unknown if the reporter considered the fever, night sweat, headache and muscle pain to be related to Shingles vaccine.  Additional details provided were as follows: The age at vaccination was not reported. The patient received 2nd dose of shingles vaccine and experienced night sweats,headache,fever and muscle pain. The patient denied to disclose any personal information.
Sex: U
Vaccine: VARZOS
Symptoms: Malaise
Clinical narrative: not feeling well; This case was reported by a consumer via interactive digital media and described the occurrence of feeling unwell in a patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   Previously administered products included Shingles vaccine (received first dose on an unknown date).   On 25th May 2021, the patient received the 2nd dose of Shingles vaccine. In May 2021, less than a week after receiving Shingles vaccine, the patient experienced feeling unwell. On an unknown date, the outcome of the feeling unwell was not recovered/not resolved.   It was unknown if the reporter considered the feeling unwell to be related to Shingles vaccine.  Additional details provided were as follows: The age at vaccination was not reported. The patient received 2nd dose of shingles vaccine and was not feeling well from it. The patient further stated that from everything he or she heard, not feeling well for a couple of days was a small price to pay to hopefully avoid getting shingles. No further information was provided.
Sex: U
Vaccine: VARZOS
Symptoms: Herpes zoster, Vaccination failure
Clinical narrative: Had the shot, got the shingles/suspected vaccination failure; got the shingles; This case was reported by a consumer via media and described the occurrence of suspected vaccination failure in a patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   On an unknown date, the patient received Shingles vaccine. On an unknown date, unknown after receiving Shingles vaccine, the patient experienced vaccination failure (serious criteria GSK medically significant) and shingles. On an unknown date, the outcome of the vaccination failure and shingles were unknown.   It was unknown if the reporter considered the vaccination failure and shingles to be related to Shingles vaccine.  Additional details were provided as follows: The reporter was the concerned patient. The age at vaccination was not reported. The patient got Shingles after vaccination. This case was considered as suspected vaccination failure as details regarding completion of primary vaccination schedule, laboratory confirmation, time to onset of shingles were unknown at the time of reporting.
Sex: U
Vaccine: VARZOS
Symptoms: Herpes zoster, Vaccination failure
Clinical narrative: I had it, but I did have the vaccine before it came/suspected vaccination failure; I had it/ Shingles; This case was reported by a consumer via media and described the occurrence of suspected vaccination failure in a patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   On an unknown date, the patient received Shingles vaccine. On an unknown date, unknown after receiving Shingles vaccine, the patient experienced vaccination failure (serious criteria GSK medically significant) and shingles. On an unknown date, the outcome of the vaccination failure and shingles were unknown.   It was unknown if the reporter considered the vaccination failure and shingles to be related to Shingles vaccine.  Additional details were provided as follows: The patient reported case for herself/himself. The age at vaccination was not reported. The patient stated he/she had shingles, but the patient did have the vaccine before shingles came. This case was considered to be a suspected vaccination failure case, as the details regarding being full vaccination schedule, laboratory confirmation for shingles and exact time to onset were unknown.
Sex: U
Vaccine: VARZOS
Symptoms: Headache, Hyperhidrosis, Pyrexia
Clinical narrative: woke up in sweats; fever; headache; This case was reported by a consumer via interactive digital media and described the occurrence of sweating in a patient who received Herpes zoster (Shingrix) for prophylaxis.   On an unknown date, the patient received the 2nd dose of Shingrix. On an unknown date, less than a week after receiving Shingrix, the patient experienced sweating, fever and headache. On an unknown date, the outcome of the sweating, fever and headache were not recovered/not resolved.   It was unknown if the reporter considered the sweating, fever and headache to be related to Shingrix.  Additional details were provided as follows: The reporter was the patient. The age at vaccination was not reported. The patient received 2nd dose of Shingrix and the patient woke up in sweats, fever and headache.  The reporter asked if duration of resolution of these symptoms.
Sex: U
Vaccine: VARZOS, VARZOS
Symptoms: Herpes zoster, Incomplete course of vaccination
Clinical narrative: recently got shingles; did not receive the 2nd shingles shot in 2018 &; This case was reported by a consumer via interactive digital media(Chatbot) and described the occurrence of shingles in a patient who received Herpes zoster (Shingrix) for prophylaxis.   Co-suspect products included Herpes zoster (Shingrix) for prophylaxis.   On an unknown date, the patient received the 1st dose of Shingrix and the 2nd dose of Shingrix. On an unknown date, unknown after receiving Shingrix and not applicable after receiving Shingrix, the patient experienced shingles and incomplete course of vaccination. On an unknown date, the outcome of the shingles and incomplete course of vaccination were unknown.   It was unknown if the reporter considered the shingles to be related to Shingrix.  Additional details were provided as follows: The case was reporetd by patient. The age at vaccination was not reported. In 2018, patient received 1st dose of Shingrix and experienced shingles. Till the time of reporting, patient did not received 2nd dose of Shingrix, which led to incomplete course of vaccination.
Sex: F
Vaccine: RAB
Symptoms: Incomplete course of vaccination, Product supply issue
Clinical narrative: Incomplete course of vaccination; pharmacy is out of stock; This case was reported by a pharmacist via call center representative and described the occurrence of incomplete course of vaccination in a 56-year-old female patient who received Rabies NVS (RabAvert) for prophylaxis.   Concomitant products included Rabies NVS (RabAvert).   On an unknown date, the patient received the 2nd dose of RabAvert. On an unknown date, unknown after receiving RabAvert and an unknown time after receiving RabAvert, the patient experienced incomplete course of vaccination and product supply issue. On an unknown date, the outcome of the incomplete course of vaccination and product supply issue were unknown.  Additional details were provided as follows: The age at vaccination was not applicable for this report. The patient was on a rabies pre-exposure prophylaxis schedule with Rabavert. The patient received 1st dose on 19th June 2020 and as the pharmacy was out of stock of Rabavert, the patient would probably not get a second dose on the date of reporting (day 7), which led to incomplete course of vaccination and product supply issue. The reporter consented to follow up.
Age: 51.0
Sex: M
Vaccine: VARZOS
Symptoms: Chills, Fatigue, Headache, Hyperhidrosis, Myalgia
Clinical narrative: experiencing feeling tired/tiredness; bad headache / felt like he got hit by a Mack truck; had severe muscle pain; assumes that he had a fever (he did not take his temperature); was shivering; had night sweats / said this that night sweats are not normal for him / he was drenched; drenching sweating; This case was reported by a consumer via call center representative and described the occurrence of tiredness in a 51-year-old male patient who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included Shingrix (received 1st dose on an unknown  date).   On 24th May 2021, the patient received the 2nd dose of Shingrix (intramuscular). On 24th May 2021, less than a day after receiving Shingrix, the patient experienced tiredness, headache, muscle pain, fever, shivering, night sweat and drenching sweats. The patient was treated with medication unknown (Migraine-A (Medication Unknown)). On an unknown date, the outcome of the tiredness, headache, muscle pain, fever, shivering, night sweat and drenching sweats were not recovered/not resolved.   The reporter considered the tiredness, headache, muscle pain, fever, shivering, night sweat and drenching sweats to be related to Shingrix.  Additional details were reported as follows: The reporter was the patient. He stated that he got his dose of Shingrix in left arm at his doctor's office around noon. He did not have the lot number or expiration date but gave permission for safety to contact his doctor's office. By evening the patient experiencing feeling tired/tiredness and a bad headache. He took unspecified  migraine medicine to help with the bad headache. He states he felt like he got hit by a Mack truck. He said that he had severe muscle pain. He also assumes that he had a fever (he did not take his temperature) because he was shivering and wrapped himself up in a heating pad. He also stated that he had sweating; he had night sweats last night. He said this that night sweats were not normal for him. He said he was drenched. He said that last night sucked, it was bad but he was better by comparison on 25th May2021. His symptoms have not fully resolved. He was calling GlaxoSmithKline to ask how long it would be before the side effects resolved completely. He said his side effects were not severe. The reporter consented to follow up.
Age: 51.0
Sex: M
Vaccine: VARZOS
Symptoms: Night sweats, Pyrexia
Clinical narrative: experiencing feeling tired/tiredness; bad headache / felt like he got hit by a Mack truck; had severe muscle pain; assumes that he had a fever (he did not take his temperature); was shivering; had night sweats / said this that night sweats are not normal for him / he was drenched; drenching sweating; This case was reported by a consumer via call center representative and described the occurrence of tiredness in a 51-year-old male patient who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included Shingrix (received 1st dose on an unknown  date).   On 24th May 2021, the patient received the 2nd dose of Shingrix (intramuscular). On 24th May 2021, less than a day after receiving Shingrix, the patient experienced tiredness, headache, muscle pain, fever, shivering, night sweat and drenching sweats. The patient was treated with medication unknown (Migraine-A (Medication Unknown)). On an unknown date, the outcome of the tiredness, headache, muscle pain, fever, shivering, night sweat and drenching sweats were not recovered/not resolved.   The reporter considered the tiredness, headache, muscle pain, fever, shivering, night sweat and drenching sweats to be related to Shingrix.  Additional details were reported as follows: The reporter was the patient. He stated that he got his dose of Shingrix in left arm at his doctor's office around noon. He did not have the lot number or expiration date but gave permission for safety to contact his doctor's office. By evening the patient experiencing feeling tired/tiredness and a bad headache. He took unspecified  migraine medicine to help with the bad headache. He states he felt like he got hit by a Mack truck. He said that he had severe muscle pain. He also assumes that he had a fever (he did not take his temperature) because he was shivering and wrapped himself up in a heating pad. He also stated that he had sweating; he had night sweats last night. He said this that night sweats were not normal for him. He said he was drenched. He said that last night sucked, it was bad but he was better by comparison on 25th May2021. His symptoms have not fully resolved. He was calling GlaxoSmithKline to ask how long it would be before the side effects resolved completely. He said his side effects were not severe. The reporter consented to follow up.
Age: 16.0
Sex: F
Vaccine: MNQ
Symptoms: Incorrect dose administered, Product preparation error
Clinical narrative: The powder portion was reconstituted with sterile diluent.; received a partial dose of Menveo; This case was reported by a other health professional via call center representative and described the occurrence of wrong solution used in drug reconstitution in a 16-year-old female patient who received Men ACWY-CRM NVS (Menveo) (batch number AMVA436A, expiry date 31st October 2021) for prophylaxis.   On 24th May 2021, the patient received Menveo. On 24th May 2021, unknown after receiving Menveo, the patient experienced wrong solution used in drug reconstitution and inappropriate dose of vaccine administered. On an unknown date, the outcome of the wrong solution used in drug reconstitution and inappropriate dose of vaccine administered were unknown.  Additional details were provided as follows:  The patient received a partial dose of Menveo as the powder portion was reconstituted with sterile diluent, which led to solution used in drug reconstitution and inappropriate dose of vaccine administered. The medical assistant consented to follow up.
Age: 55.0
Sex: F
Vaccine: HEP
Symptoms: Wrong product administered
Clinical narrative: patient received Twinrix then as a second dose received Engerix; This case was reported by a pharmacist via call center representative and described the occurrence of wrong vaccine administered in a 55-year-old female patient who received HBV (Engerix B adult) (batch number 54A32, expiry date unknown) for prophylaxis.   Co-suspect products included hepatitis B vaccine pre-filled syringe device injection syringe for prophylaxis.   Previously administered products included Twinrix (received a dose of Twinrix on an unknown date).   On an unknown date, the patient received Engerix B adult and hepatitis B vaccine pre-filled syringe device. On an unknown date, unknown after receiving Engerix B adult and hepatitis B vaccine pre-filled syringe device, the patient experienced wrong vaccine administered. On an unknown date, the outcome of the wrong vaccine administered was unknown.   This report is made by GSK without prejudice and does not imply any admission or liability for the incident or its consequences.  Additional details were provided as follows: The patient received 1st dose of Twinrix and then as a second dose received Engerix B 20MCG/ML, which led to wrong vaccine administered. The pharmacist asked information on how to proceed for the patient's vaccination series. The reporter did not consent to follow up.
Sex: M
Vaccine: VARZOS
Symptoms: Fatigue, Myalgia, Pain in extremity
Clinical narrative: muscle aches; Fatigue; Arm soreness; This case was reported by a consumer via call center representative and described the occurrence of muscle pain in a male patient who received Herpes zoster (Shingrix) for prophylaxis.   On 25th May 2021, the patient received the 1st dose of Shingrix. In May 2021, less than a week after receiving Shingrix, the patient experienced muscle pain, fatigue and pain in arm. On an unknown date, the outcome of the muscle pain, fatigue and pain in arm were not recovered/not resolved.   It was unknown if the reporter considered the muscle pain, fatigue and pain in arm to be related to Shingrix.  Additional details were provided as follows:  The case was reported by the patient for himself. The age at vaccination was not reported. The patient's limited demographic information was available.  The patient experienced muscle aches, fatigue and arm soreness post vaccination. The symptoms were ongoing at the time of reporting. The reporter did not consent to follow up.
Age: 0.17
Sex: F
Vaccine: HEP, HEP
Symptoms: Inappropriate schedule of product administration
Clinical narrative: First dose was given on 10Dec2020, 2nd dose on 10Feb2021 and third dose on 18May2021; First dose was given on 10Dec2020, 2nd dose on 10Feb2021 and third dose on 18May2021; This case was reported by a other health professional via call center representative and described the occurrence of drug dose administration interval too short in a 6-month-old female patient who received HBV (Engerix B pediatric) (batch number MY3RA, expiry date 21st September 2022) for prophylaxis.   Co-suspect products included hepatitis B vaccine pre-filled syringe device (Engerix B Pre-Filled Syringe Device) injection syringe for prophylaxis, HBV (Engerix B pediatric) for prophylaxis and hepatitis B vaccine pre-filled syringe device (Engerix B Pre-Filled Syringe Device) injection syringe for prophylaxis.   Previously administered products included Bexsero with an associated reaction of no adverse event (1st dose received on 10th December 2020).   On 18th May 2021, the patient received the 3rd dose of Engerix B pediatric and Engerix B Pre-Filled Syringe Device. On 10th February 2021, the patient received the 2nd dose of Engerix B pediatric and Engerix B Pre-Filled Syringe Device. On 10th February 2021, not applicable after receiving Engerix B pediatric and Engerix B Pre-Filled Syringe Device and unknown after receiving Engerix B pediatric and Engerix B Pre-Filled Syringe Device, the patient experienced drug dose administration interval too long. On 18th May 2021, the patient experienced drug dose administration interval too short. On an unknown date, the outcome of the drug dose administration interval too short and drug dose administration interval too long were unknown.   This report is made by GSK without prejudice and does not imply any admission or liability for the incident or its consequences.  Additional details were provided as follows: The patient received 2nd dose of engerix B pediatric, more than recommended interval, which led to lengthening of vaccination schedule. The patient received 3rd dose of engerix B pediatric, less than recommended interval, which led to shortening of vaccination schedule. The Health care professional (HCP) did not have the lot number or expiry date for 2nd dose.
Sex: U
Vaccine: VARZOS
Symptoms: Tremor
Clinical narrative: experienced shaking for about one hour; This case was reported by a pharmacist via call center representative and described the occurrence of tremor in a patient who received Herpes zoster (Shingrix) for prophylaxis.   On 24th February 2021, the patient received the 1st dose of Shingrix. In February 2021, less than a day after receiving Shingrix, the patient experienced tremor. On an unknown date, the outcome of the tremor was unknown.   It was unknown if the reporter considered the tremor to be related to Shingrix.  Additional details were provided as follows: The age at vaccination was not reported. The patient had taken first dose of Shingrix and experienced shaking for about one hour afterward. The health care professional did not have time during the call to answer additional questions. The reporter not consent to follow up via Email.
Age: 60.0
Sex: M
Vaccine: VARZOS
Symptoms: Extra dose administered
Clinical narrative: Administrating a third dose of Shingrix by mistake to the patient; This case was reported by a pharmacist via call center representative and described the occurrence of extra dose administered in a 60-year-old male patient who received Herpes zoster (Shingrix) (batch number 453LA, expiry date 18th February 2022) for prophylaxis.   Previously administered products included Shingrix (1st dose received on an unknown date) and Shingrix (2nd dose received on an unknown date).   On 26th May 2021, the patient received the 3rd dose of Shingrix. On 26th May 2021, unknown after receiving Shingrix, the patient experienced extra dose administered. On an unknown date, the outcome of the extra dose administered was unknown.  Additional details were provided as follows:  The Patient's age was reported to be 61 years. The patient received the 3rd dose of Shingrix by mistake, which led to extra dose received. The pharmacist did not consent nor denied follow up.  No further events were reported.
Age: 51.0
Sex: F
Vaccine: VARZOS
Symptoms: Blister, Fatigue, Herpes zoster, Influenza like illness, Pain
Clinical narrative: shingles on the underside of her RIGHT arm; aches and pain; Flu-like symptoms; tiredness; rash/ developed after she took a hot shower; blisters developed after she took a hot shower; This case was reported by a consumer via call center representative and described the occurrence of shingles in a 51-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   On 11th May 2021, the patient received the 1st dose of Shingrix (intramuscular). On 12th May 2021, 1 days after receiving Shingrix, the patient experienced pain, influenza-like symptoms and tiredness. In May 2021, the patient experienced rash and blister. On 25th May 2021, the patient experienced shingles. The patient was treated with valaciclovir hydrochloride (Valacyclovir). On 14th May 2021, the outcome of the pain, influenza-like symptoms and tiredness were recovered/resolved. On an unknown date, the outcome of the shingles was not recovered/not resolved and the outcome of the rash and blister were unknown.   It was unknown if the reporter considered the shingles, rash and blister to be related to Shingrix. The reporter considered the pain, influenza-like symptoms and tiredness to be related to Shingrix.  Additional details were provided as follows: The patient reported case for herself. The patient received Shingrix vaccine in her right arm. The patient 1 day after receiving the Shingrix vaccine began to have flu-like symptoms, aches and pains and tiredness which all resolved in 2 days. A day before reporting on 25th May 2021, the patient developed shingles on the underside of her right arm. The patient reported that in less than 2 weeks, the rash and blisters developed after she took a hot shower. The patient's health care professional started her on Valacyclovir 1gm trice a day for 7 days, which she started taking on the dat of reporting, 26th May 2021. The reporter did not consent to follow up. The patient did not give permission to contact health care professional.
Age: 51.0
Sex: F
Vaccine: VARZOS
Symptoms: Rash
Clinical narrative: shingles on the underside of her RIGHT arm; aches and pain; Flu-like symptoms; tiredness; rash/ developed after she took a hot shower; blisters developed after she took a hot shower; This case was reported by a consumer via call center representative and described the occurrence of shingles in a 51-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   On 11th May 2021, the patient received the 1st dose of Shingrix (intramuscular). On 12th May 2021, 1 days after receiving Shingrix, the patient experienced pain, influenza-like symptoms and tiredness. In May 2021, the patient experienced rash and blister. On 25th May 2021, the patient experienced shingles. The patient was treated with valaciclovir hydrochloride (Valacyclovir). On 14th May 2021, the outcome of the pain, influenza-like symptoms and tiredness were recovered/resolved. On an unknown date, the outcome of the shingles was not recovered/not resolved and the outcome of the rash and blister were unknown.   It was unknown if the reporter considered the shingles, rash and blister to be related to Shingrix. The reporter considered the pain, influenza-like symptoms and tiredness to be related to Shingrix.  Additional details were provided as follows: The patient reported case for herself. The patient received Shingrix vaccine in her right arm. The patient 1 day after receiving the Shingrix vaccine began to have flu-like symptoms, aches and pains and tiredness which all resolved in 2 days. A day before reporting on 25th May 2021, the patient developed shingles on the underside of her right arm. The patient reported that in less than 2 weeks, the rash and blisters developed after she took a hot shower. The patient's health care professional started her on Valacyclovir 1gm trice a day for 7 days, which she started taking on the dat of reporting, 26th May 2021. The reporter did not consent to follow up. The patient did not give permission to contact health care professional.
Age: 72.0
Sex: F
Vaccine: VARZOS
Symptoms: Accidental underdose, Product preparation issue
Clinical narrative: Diluent portion dropped up during reconstitution / final volume was 0.45ml / administered; Diluent portion dropped up during reconstitution / vaccines was administered; This case was reported by a pharmacist via call center representative and described the occurrence of accidental underdose in a 72-year-old female patient who received Herpes zoster (Shingrix) (batch number MB7RR, expiry date 8th October 2022) for prophylaxis.   On 26th May 2021, the patient received Shingrix .45 ml. On 26th May 2021, unknown after receiving Shingrix, the patient experienced accidental underdose and inappropriate reconstitution technique. On an unknown date, the outcome of the accidental underdose and inappropriate reconstitution technique were unknown.  Additional details were provided as follows: The reporter stated that, while administering Shingrix the diluent portion dropped up during reconstitution and the final volume was 0.45 ml, which led to inappropriate reconstitution technique and accidental underdose.  The reporter was looking for guidance. The reporter consented to follow up.
Sex: U
Vaccine: DTAPHEPBIP
Symptoms: Expired product administered
Clinical narrative: Administration of an expired dose of Pediarix; This case was reported by a other health professional via call center representative and described the occurrence of expired vaccine used in a patient who received DTPa-HBV-IPV (Pediarix) (batch number K7TF9, expiry date 24th May 2021) for prophylaxis.   Co-suspect products included dtpa-hbv-ipv vaccine pre-filled syringe device (Pediarix Pre-Filled Syringe Device) injection syringe for prophylaxis.   On 26th May 2021, the patient received Pediarix and Pediarix Pre-Filled Syringe Device. On 26th May 2021, unknown after receiving Pediarix and Pediarix Pre-Filled Syringe Device, the patient experienced expired vaccine used. On an unknown date, the outcome of the expired vaccine used was unknown.   This report is made by GSK without prejudice and does not imply any admission or liability for the incident or its consequences.  Additional details were provided as follows: Age at vaccination was not reported. The reporter informed that, Pediarix dose was given on 26th May 2021 which was expired on 24th May 2021, which led to expired vaccine used. The reporter did not consented to follow up.
Age: 51.0
Sex: F
Vaccine: VARZOS
Symptoms: Incorrect dose administered, No adverse event, Product preparation error
Clinical narrative: Patient received her second dose / powder was reconstituted with sterile water; Patient received her second dose / powder was reconstituted with sterile water; This case was reported by a other health professional via call center representative and described the occurrence of wrong solution used in drug reconstitution in a 51-year-old female patient who received Herpes zoster (Shingrix) (batch number E9C7K, expiry date 14th October 2022) for prophylaxis.   Previously administered products included Shingrix with an associated reaction of no adverse event (1st dose received on 22nd December 2020).   On 25th May 2021, the patient received the 2nd dose of Shingrix. On 25th May 2021, unknown after receiving Shingrix, the patient experienced wrong solution used in drug reconstitution and inappropriate dose of vaccine administered. On an unknown date, the outcome of the wrong solution used in drug reconstitution and inappropriate dose of vaccine administered were unknown.  Additional details were reported as follows: The patient received 2nd dose of Shingrix but the powder was reconstituted with sterile water, which led to wrong solution used in drug reconstitution and inappropriate dose of vaccine administered. No further events were reported at the time of the phone call. The reporter consented to follow up via an email.
Sex: F
Vaccine: VARZOS
Symptoms: Incomplete course of vaccination
Clinical narrative: got first dose / 16 months ago and has not gotten the second dose; This case was reported by a pharmacist via call center representative and described the occurrence of incomplete course of vaccination in a 54-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included Shingrix (1st dose received intramuscularly, 16 months ago of the reporting date).   On an unknown date, the patient received the 2nd dose of Shingrix. On an unknown date, unknown after receiving Shingrix, the patient experienced incomplete course of vaccination. On an unknown date, the outcome of the incomplete course of vaccination was unknown.  Additional details were provided as follows:  The age at vaccination was not applicable for this report. Till the time of reporting patient did not receive 2nd dose of Shingrix, which led to incomplete course of vaccination. The reporter did not consent to follow up.
Sex: M
Vaccine: COVID19
Symptoms: Cough, Hyperhidrosis, Malaise, Rhinorrhoea, Sinus congestion
Clinical narrative: SWEATING A LOT; COUGHING; CONGESTION; LOTS OF MUCUS; FELT SICK; This spontaneous report received from a patient concerned a 44 year old male. The patient's height, and weight were not reported.  No past medical history or concurrent conditions were reported.  The patient received covid-19 vaccine  (suspension for injection, route of admin not reported, batch number: 041A12A, expiry: UNKNOWN) dose was not reported, administered on 05-MAY-2021 for prophylactic vaccination.  No concomitant medications were reported.  On 09-MAY-2021, the subject experienced sweating a lot, coughing, congestion, lots of mucus, felt sick. The action taken with covid-19 vaccine  was not applicable. The outcome of the sweating a lot, felt sick, coughing, congestion and lots of mucus was not reported. This report was non-serious.; Sender's Comments: V0: Medical Assessment comment was not required as per standard procedure as the case assessed as non-serious.
Age: 44.0
Sex: U
Vaccine: COVID19
Symptoms: Pulmonary embolism, Pulseless electrical activity
Clinical narrative: MASSIVE BILATERAL PULMONARY EMBOLISM; PEA  ARREST; This spontaneous report received from a health care professional concerned a 44 year old of unspecified sex, race and ethnicity. The patient's height, and weight were not reported. No past medical history or concurrent conditions were reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, and batch number: 1805018 expiry: unknown) dose was not reported, frequency once total, administered on 23-MAR-2021 for prophylactic vaccination. No concomitant medications were reported.  On 01-MAY-2021, the patient experienced bilateral pulmonary emboli classified as massive and was hospitalized, and experienced pulseless electrical activity (PEA) arrest in the setting. Patient was discharged on 16-MAY-2021. Patient was hospitalized for 16 days. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from massive bilateral pulmonary embolism on 16-MAY-2021, and PEA arrest. This report was serious (Hospitalization Caused / Prolonged, and Other Medically Important Condition).; Sender's Comments: V0:20210547403-covid-19 vaccine ad26.cov2.s -Massive bilateral pulmonary emboli, pulseless electrical activity arrest This event(s) is considered unassesable. The event(s) has a compatible/suggestive temporal relationship, is unlabeled, and has unknown scientific plausibility. There is no information on any other factors potentially associated with the event(s).
Sex: F
Vaccine: COVID19
Symptoms: Haematoma
Clinical narrative: HEMATOMAS ON BOTH LEGS ONE LEG LOOKS BIGGER AND TO THE OTHER LEG BEGINNING TO FORM HEMATOMAS; This spontaneous report received from a patient via a company representative concerned a female of unspecified age. The patient's height, and weight were not reported. No past medical history or concurrent conditions were reported. The patient received covid-19 vaccine (suspension for injection, route of admin not reported, batch number: UNKNOWN) dose was not reported, administered on 13-MAY-2021 for prophylactic vaccination. The batch number was not reported and has been requested.  No concomitant medications were reported.  On MAY-2021, the subject experienced hematomas on both legs one leg looks bigger and to the other leg beginning to form hematomas. The action taken with covid-19 vaccine  was not applicable. The patient had not recovered from hematomas on both legs one leg looks bigger and to the other leg beginning to form hematomas. This report was non-serious.
Sex: M
Vaccine: COVID19
Symptoms: Arthralgia, Asthma, Disturbance in attention, Headache, Hypertension
Clinical narrative: DIFFICULTY CONCENTRATING; SLIGHTLY ELEVATED HIGH BLOOD PRESSURE; MODERATE ASTHMA; MILD JOINT PAIN; SLIGHT HEADACHE; This spontaneous report received from a patient concerned a male of unspecified age. The patient's height, and weight were not reported. No past medical history or concurrent conditions were reported. The patient received covid-19 vaccine  (suspension for injection, route of admin not reported, batch number: Unknown) dose, start therapy date were not reported for prophylactic vaccination. The batch number was not reported and has been requested. No concomitant medications were reported. On an unspecified date, the subject experienced difficulty concentrating, slightly elevated high blood pressure, moderate asthma, mild joint pain, and slight headache. The action taken with covid-19 vaccine was not applicable. The outcome of the slight headache, difficulty concentrating, slightly elevated high blood pressure, mild joint pain and moderate asthma was not reported. This report was non-serious.
Sex: M
Vaccine: COVID19
Symptoms: Chills, Insomnia, Multiple sclerosis, Nausea
Clinical narrative: EXACERBATION OF MULTIPLE SCLEROSIS; NAUSEA; COULD NOT SLEEP; CHILLS; This spontaneous report received from a patient concerned a male of unspecified age. The patient's height, and weight were not reported. The patient's concurrent conditions included seasonal allergy, alcohol consumption, multiple sclerosis, and non smoker, and other pre-existing medical conditions included the patient is on keto diet. the patients found hard to drink alcohol with the diet and works 6 days per week. The patient is treated with naltrexone for multiple sclerosis. The patient took off-label low dose of naltrexone.  The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, intramuscular, and batch number: 205A21A expiry: 23-JUN-2021) .5 ml, frequency 1, total, administered on 24-MAY-2021 on left arm around 11:00 am for prophylactic vaccination. Concomitant medications included ibuprofen for drug used for unknown indication.  On 24-May-2021, around 8:30 pm and before bed, he had chills and could not get warm. He also could not sleep. He drank tons of water because he heard he should drink plenty of water with vaccinations. At 1 am on 25-May-2021, he woke up to urinate because of drinking tons of water and he had the worst MS exacerbation that he has ever experienced and it was long-lasting; he had zero balance, no leg strength, vertigo, and nausea, and he missed this day of work. He took two Advil 200 mg tablets at 1 am, 1 more at 2:30 am, and 1 about one hour before providing this report (2:00 pm). His daughter checked in on him but he was okay. As of 25-May-2021, his motor function is coming back, but his stamina is bad, he has weakness when trying to get around which is accompanied with more nausea. Otherwise, the nausea and vertigo, which occur simultaneously are better, loss of leg strength is better, and the loss of stamina and weakness persist The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from chills on 25-MAY-2021, was recovering from exacerbation of multiple sclerosis and nausea and the outcome of could not sleep was not reported. This report was serious (Other Medically Important Condition).; Sender's Comments: V0: 20210549148-covid-19 vaccine ad26.cov2.s-Exacerbation of multiple sclerosis. This event(s) is considered not related. The event(s) has a compatible/suggestive temporal relationship, is unlabeled, and has unknown scientific plausibility. There are other factors more likely to be associated with the event(s) than the drug. Specifically: MEDICAL HISTORY