chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Sex: U
Vaccine: COVID19, COVID19
Symptoms: Drug ineffective, Suspected COVID-19
Clinical narrative: This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient. A patient (no qualifiers provided) received BNT162b2 (BNT162B2), in Aug2021 as dose 1, single (Batch/Lot number: unknown) and in Aug2021 as dose 2, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history included: "Bullous Pemphigoid" (unspecified if ongoing), notes: This is the 8th year have auto immune disease. The patient's concomitant medications were not reported. Vaccination history included: Bnt162b2 (dose 1), administration date: Aug2021, for COVID-19 immunization, reaction(s): "Bullous Pemphigoid". The following information was reported: DRUG INEFFECTIVE (medically significant), SUSPECTED COVID-19 (medically significant) all with onset 04Jul2022, outcome "unknown" and all described as "got COVID/very sick for 10days. Very bad sore throat extreme fatigue and no fever". Patient had been ok until got COVID on 04Jul2022. Patient thought omicron. The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.
Age: 35.0
Sex: F
Vaccine: HPV9
Symptoms: Anxiety, Caesarean section, Depression, Exposure during pregnancy, Foetal heart rate decreased
Clinical narrative: On April18 2022, I was 34 weeks of pregnancy. I supposed to receive Tdap, however the OB office gave me HPV vaccine by mistake.  No medical treatment was given after the wrong vaccine shot. After knowing the mistake, I suffered panic attack, anxiety and depression. At 38 week, I was rush to emergency C-section because the fetal heart rate was dropping fast. The baby weighted 5lb 12oz when born, and she was diagnosed SGA(small for gestational age). Three days after, baby was diagnosed ASD (atrial septal defect), VSD (ventricular septal defect).
Age: 35.0
Sex: F
Vaccine: HPV9
Symptoms: Panic attack, Wrong product administered
Clinical narrative: On April18 2022, I was 34 weeks of pregnancy. I supposed to receive Tdap, however the OB office gave me HPV vaccine by mistake.  No medical treatment was given after the wrong vaccine shot. After knowing the mistake, I suffered panic attack, anxiety and depression. At 38 week, I was rush to emergency C-section because the fetal heart rate was dropping fast. The baby weighted 5lb 12oz when born, and she was diagnosed SGA(small for gestational age). Three days after, baby was diagnosed ASD (atrial septal defect), VSD (ventricular septal defect).
Age: 31.0
Sex: M
Vaccine: COVID19
Symptoms: Malaise, Vaccination site pain
Clinical narrative: My arm at the site of the vaccination has been sore for almost one year now. I will feel it sporadically throughout the day. There are times when it pulses. I put a heating pad on it and it was rapidly pulsing. Feels much different than the other arm and it is noticeably near the vaccine location in the upper arm. I have noticed that the more I feel it, the more unwell/sick I feel. I have considered getting leeches or doing something to counteract this problem.
Age: 68.0
Sex: F
Vaccine: COVID19, COVID19, COVID19, COVID19
Symptoms: Arthralgia, Pain in extremity, Trigger finger, X-ray limb
Clinical narrative: January 2022 I noticed my RIGHT THUMB from the first joint down to the palm of my hand really hurts.  The first joint is most painful.  I sought the attention of my doctor, who referred me to a specialist.  The specialist, after the X-ray and examination, told me I have what they call, a "Trigger Finger".  Typical solutions would be:  1) Injections of Cortisone for pain relief, or 2) Surgery.  He told me neither solution is guaranteed for lasting relief or there's no guarantee that another digit won't be affected.    Since July 17th I've been consuming BONE BROTH PROTEIN POWDER once a day.  It appears to be helping with pain relief and movement.
Age: 37.0
Sex: F
Vaccine: COVID19, PNC20
Symptoms: Cold sweat, Diarrhoea, Dizziness, Dyspnoea, Fatigue
Clinical narrative: Dizziness 4:08 pm On8/12/22 Running nose on and off plus Sleepiness 5:30. On 8/12/22. Arm soreness  and sneezing around 6pm. On 8/12/22 Fatigue and clammy sweat around 7pm. 10 am on 8/13/22 diarrhea with nausea. Arm pain and swelling increased even though otc Tylenol.  On and off from 8/14/22 diarrhea on and off.  Clammy and occasional shortness of breath on and off 8/15/22 plus continued fatigue.
Age: 37.0
Sex: F
Vaccine: COVID19, PNC20
Symptoms: Hyperhidrosis, Nausea, Pain in extremity, Peripheral swelling, Rhinorrhoea
Clinical narrative: Dizziness 4:08 pm On8/12/22 Running nose on and off plus Sleepiness 5:30. On 8/12/22. Arm soreness  and sneezing around 6pm. On 8/12/22 Fatigue and clammy sweat around 7pm. 10 am on 8/13/22 diarrhea with nausea. Arm pain and swelling increased even though otc Tylenol.  On and off from 8/14/22 diarrhea on and off.  Clammy and occasional shortness of breath on and off 8/15/22 plus continued fatigue.
Age: 37.0
Sex: F
Vaccine: COVID19, PNC20
Symptoms: Sneezing, Somnolence
Clinical narrative: Dizziness 4:08 pm On8/12/22 Running nose on and off plus Sleepiness 5:30. On 8/12/22. Arm soreness  and sneezing around 6pm. On 8/12/22 Fatigue and clammy sweat around 7pm. 10 am on 8/13/22 diarrhea with nausea. Arm pain and swelling increased even though otc Tylenol.  On and off from 8/14/22 diarrhea on and off.  Clammy and occasional shortness of breath on and off 8/15/22 plus continued fatigue.
Age: 6.0
Sex: M
Vaccine: HEPA, MMR, UNK, VARCEL
Symptoms: Abdominal pain upper, Blindness, Chest pain, Crying, Dyskinesia
Clinical narrative: Patient with previous adverse reaction to vaccinations was taken to get "caught up" in order to attend school the following week.   Patient complained of stomach ache, chest pain, headache and intermittent loss of vision on the drive home. Reports father didn't believe him, and father reports no fever, or other symptoms. Transferred to mother three days later, and patient reported symptoms were repeating. Complained again of headache, and was alseep within moments of the comment. A couple hours later, patient woke up crying, and was unresponsive to queries about what was happening. All touch was overstimulating, and limbs jerked erratically. Patient was hyperventilating and continued to be unresponsive to questions. Mother held patient to calm him and he fell asleep for a moment, then began crying and flailing again. This went on for at least twenty to thirty minutes and patient began to scratch at his body, particularly his feet. Mother touched his foot and felt a steady shocking sensation. Mother took to doctor, who gave detox protocol.  Over a week later, patient is still experiencing pain at the injection sites and having unusual sleeping patterns.
Age: 6.0
Sex: M
Vaccine: HEPA, MMR, UNK, VARCEL
Symptoms: Electric shock sensation, Headache, Hyperventilation, Injection site pain, Sleep disorder
Clinical narrative: Patient with previous adverse reaction to vaccinations was taken to get "caught up" in order to attend school the following week.   Patient complained of stomach ache, chest pain, headache and intermittent loss of vision on the drive home. Reports father didn't believe him, and father reports no fever, or other symptoms. Transferred to mother three days later, and patient reported symptoms were repeating. Complained again of headache, and was alseep within moments of the comment. A couple hours later, patient woke up crying, and was unresponsive to queries about what was happening. All touch was overstimulating, and limbs jerked erratically. Patient was hyperventilating and continued to be unresponsive to questions. Mother held patient to calm him and he fell asleep for a moment, then began crying and flailing again. This went on for at least twenty to thirty minutes and patient began to scratch at his body, particularly his feet. Mother touched his foot and felt a steady shocking sensation. Mother took to doctor, who gave detox protocol.  Over a week later, patient is still experiencing pain at the injection sites and having unusual sleeping patterns.
Age: 6.0
Sex: M
Vaccine: HEPA, MMR, UNK, VARCEL
Symptoms: Unresponsive to stimuli
Clinical narrative: Patient with previous adverse reaction to vaccinations was taken to get "caught up" in order to attend school the following week.   Patient complained of stomach ache, chest pain, headache and intermittent loss of vision on the drive home. Reports father didn't believe him, and father reports no fever, or other symptoms. Transferred to mother three days later, and patient reported symptoms were repeating. Complained again of headache, and was alseep within moments of the comment. A couple hours later, patient woke up crying, and was unresponsive to queries about what was happening. All touch was overstimulating, and limbs jerked erratically. Patient was hyperventilating and continued to be unresponsive to questions. Mother held patient to calm him and he fell asleep for a moment, then began crying and flailing again. This went on for at least twenty to thirty minutes and patient began to scratch at his body, particularly his feet. Mother touched his foot and felt a steady shocking sensation. Mother took to doctor, who gave detox protocol.  Over a week later, patient is still experiencing pain at the injection sites and having unusual sleeping patterns.
Sex: U
Vaccine: VARCEL
Symptoms: Expired product administered, Product storage error
Clinical narrative: no other adverse events reported; given an expired VARIVAX; temperature excursion/Temperature 46F; This spontaneous report was received from a medical assistant referring to a patient of unknown age and gender. The patient's concomitant medication, pertinent medical history and drug reactions/allergies were not reported.  On 18-JUL-2022, the patient was vaccinated with one dose expired varicella virus vaccine live (oka/merck) (VARIVAX) subcutaneous injection (lot #U020239 had verified to be a valid lot #, labeled  expiration date: 28-JUN-2023; route, strength and anatomical location was not provided) for prophylaxis (expired product administered). The vaccines varicella virus vaccine live (oka/merck) (VARIVAX) underwent temperature excursions of 46 Fahrenheit (F) for 264 hours (product storage error). The expiration date was short dated to 11-MAY-2022 after experiencing a temperature excursion. It was reported that the suspect vaccine was administered after short-dated expiry date but prior to labeled expiry date. There was no previous temperature excursion. And the reporter inquired about revaccination. No additional adverse event details were provided (no adverse event).
Age: 49.0
Sex: U
Vaccine: MMR
Symptoms: Incorrect route of product administration
Clinical narrative: No additional AE; MMRII had been administered Intramuscularly instead of subcutaneously; This spontaneous report has been received from a pharmacist, regarding a 49-year-old patient of unknown gender.  The patient's pertinent medical history, drug reactions, allergiesand concomitant medications were unknown.   On 11-JUN-2022, the patient was vaccinated with measles, mumps, and rubella (wistar ra 27-3) virus vaccine, live  (therapy type recombinant Human albumin (rHA) (M-M-R II) subcutaneous injection but administered intramuscularly for prophylaxis with lot number W009105, which had been verified to be a valid number; expiration date 04-DEC-2023, and upon internal validation established as the same date (incorrect route of product administration) (strength, dosage, vaccine frequency scheme and anatomical site of injection were not provided). There was no adverse events reported.
Sex: U
Vaccine: RV5
Symptoms: No adverse event, Product storage error
Clinical narrative: No additional AE or PQC reported.; ROTATEQ was administered after a temperature excursion. Temperature: 10.8C Time frame: 4 hours 12 minutes 0 seconds; This spontaneous report was received from a nurse referring to a patient of unknown age and gender.  The patient's pertinent medical history, concurrent conditions, previous drug reactions or allergies and concomitant medications were not provided.   On 13-JUL-2022, the patient was vaccinated with an improperly stored dose of rotavirus vaccine, live, oral, pentavalent (ROTATEQ), lot number 1837116 has been verified to be a valid lot number with expiration date on 24-MAR-2023 (dose, strength, route of administration, anatomical injection site and frequency were not reported), administered for prophylaxis, that underwent a temperature excursion of 10.8 Celsius degrees for 4 hours and 12 minutes (improper storage of product in use). There was no previous temperature excursion. No additional adverse events were reported.
Age: 12.0
Sex: M
Vaccine: HPV9
Symptoms: Asymptomatic COVID-19, Injection site erythema, Injection site streaking, SARS-CoV-2 test positive
Clinical narrative: tested positive for COVID-19; He experienced redness/streaking in the arm that received vaccination.; streaking in the arm that received vaccination.; This spontaneous report was received from a the patient's grandmother and refers to a 12-year-old male patient.  The patient's medical history was not reported. The patient's concurrent conditions included  asthma. Concomitant therapies were not reported.  In July 2022 (reported as "about 3-4 weeks ago"), the patient was vaccinated with the first dose of 9-valent Human Papillomavirus (types 16, 18, 31, 33, 45, 52, 58, 6 and 11) recombinant vaccine (GARDASIL 9) (dosage regimen, route of administration, lot #, and expiry date were not reported) as prophylaxis.  On an unspecified date in July 2022, the patient experienced redness and streaking in the arm that received vaccination. The reporter stated that the pediatrician stated it was a localized reaction from injection and no cause for concern. On 23-JUL-2022, the patient tested positive for COVID-19, with no symptoms. At the time of report, the outcome of the events was not known.   The causal relationship between the events and 9-valent Human Papillomavirus (types 16, 18, 31, 33, 45, 52, 58, 6 and 11) recombinant vaccine (GARDASIL 9) was not provided.
Age: 0.17
Sex: F
Vaccine: RV5
Symptoms: Expired product administered
Clinical narrative: No additional AE information reported; HCP called to report that ROTATEQ vaccine that expired on 7/14/2022, was inadvertently administered to two patients after the expiration date.; This spontaneous report has been received from a medical assistant, referring to a 9-week-old female patient. The patient's concurrent conditions, medical history, concomitant medications, previous drug reactions, or allergies were not provided.  On 22-JUL-2022, the patient was vaccinated with an expired dose of rotavirus vaccine, live, oral, pentavalent (ROTATEQ) 2 ml  orally (lot number 1742080 has been verified to be a valid lot number, expiry date 14-JUL-2022) (strength, and frequency were not provided) indicated as prophylaxis (expired product administered).   Furthermore, the reporter stated that the vaccine did not experience any temperature excursion prior to administration and no additional adverse events were reported.
Sex: U
Vaccine: MMR
Symptoms: No adverse event, Product storage error
Clinical narrative: No additional information available. No additional adverse events.; Caller is medical assistant requesting four doses administered of improperly stored MMR II.; This spontaneous report was received from a medical assistant, referring to a patient of unknown age and gender.  The patient's medical history, concurrent conditions and concomitant therapies were not reported.  On 28-JUL-2022, the patient was vaccinated with an improperly storage dose of measles, mumps, and rubella (WISTAR RA 27-3) virus vaccine, live (M-M-R II) rHA (valid lot #U022174, expiration date: 14-JUL-2023) (strength, anatomical location and route of administration were not provided) for prophylaxis. Temperature excursion was at 10.1 degree Celsius (C) for 15 minutes. No previous temperature excursion occurred. No additional information adverse events were reported.  This is one of several reports with the same reporter (captured in MARRS# 2208USA003290, MARRS# 2208USA003578, and MARRS# 2208USA003711).; Sender's Comments:  US-009507513-2208USA003290: US-009507513-2208USA003578: US-009507513-2208USA003711:
Age: 1.0
Sex: F
Vaccine: VARCEL
Symptoms: Incorrect dose administered, No adverse event
Clinical narrative: No additonal AE´s; the patient actually received two doses of VARIVAX.; This spontaneous report was received from a medical assistant, referring to a 4-year-old female patient.  The patient's medical history, concurrent conditions and concomitant therapies were not reported.  On an unknown date in 2019, the patient was vaccinated with the first dose of varicella virus vaccine live (OKA/MERCK) (VARIVAX) (strength, lot #, expiry date, anatomical location and route of administration were not provided) for prophylaxis. On 05-AUG-2022, the patient received the second dose of the vaccine, but received an additional dose of varicella virus vaccine live (OKA/MERCK) (VARIVAX). The healthcare professional reported that the subject received a larger dose than recommended (Extra dose administered) but she did not experience any side effects. No information was provided.
Sex: U
Vaccine: MMRV
Symptoms: No adverse event, Product storage error
Clinical narrative: No additional AE information provided.; Nurse reporting AE for improperly stored PROQUAD administered.; This spontaneous report was received from a nurse, referring to a patient of unknown age and gender.  The patient's medical history, concurrent conditions and concomitant therapies were not reported.  On 05-AUG-2022, the patient was vaccinated with one improperly storage dose of measles, mumps, rubella, and varicella (OKA-MERCK) virus vaccine live (PROQUAD) rHA (valid lot #W002783, expiration date: 24-JUL-2023) (strength, anatomical location and route of administration were not provided) for prophylaxis. Temperature excursion was at -12 degree Celsius (C) for 40 minutes. Previous temperature excursion occurred (temperature (Temp): -14.5 C for 10 minutes; Temp: -14.2 C for 40 minutes). No additional adverse event was reported.; Sender's Comments:  US-009507513-2208USA004029:Case #  02220598 US-009507513-2208USA004112:
Sex: U
Vaccine: MMR, VARCEL
Symptoms: Product storage error
Clinical narrative: No additional adverse events; administered doses of improperly stored vaccines; This spontaneous report has been received from a medical assistant, referring a patient of unknown age and gender. The patient's concurrent conditions, medical history, concomitant medications, previous drug reactions, or allergies were not provided.  On 30-JUN-2022, the patient was vaccinated with 1 improperly stored dose of measles, mumps, and rubella (Wistar RA 27-3) virus vaccine, live (M-M-R II) (lot number U006485 has been verified to be a valid lot number, expiry date 26-FEB-2023), and  1 improperly stored dose of varicella virus vaccine live (Oka/Merck) (VARIVAX) (lot number U002400 has been verified to be a valid lot number, expiry date 22-JAN-2023) (strengths, doses, frequencies, routes of administration, and anatomical locations were not provided) both vaccines indicated as prophylaxis.  The measles, mumps, rubella and varicella (oka merck) virus vaccine live (M-M-R II) was stored at a temperature of above 8 degree Celcius (C) (8.8C) for 1 hour 27 minutes and 0 seconds; above 8 C (8.SC) for 6 hours 39 minutes and 0 seconds, above 8 C (8.8 C) for 8 hours 45 minutes and 0 seconds; above 8 C (10.7C) for 11 hours 42 minutes and 0 seconds; above 8 C (9.83C) for 18 hours 48 minutes and 0 seconds; above 8 C (9.5 C) for 14 hours 10 minutes and 0 seconds, and above 8 C (9.OC) for 9 hours 24 minutes and 0 seconds. The varicella virus vaccine live (Oka/Merck) (VARIVAX) was stored a t a temperature of  -14°C up to -10°C (-13.1C) for 18 minutes; and -14°C up to -10°C (-11.9C)  for 21 minutes. There was no previous temperature excursion.  No additional adverse events were reported.     9.5 Fahrenheit (F) for the time frame of 35 minutes. There was no previous temperature excursion.  No additional adverse events reported.
Sex: F
Vaccine: HPV9
Symptoms: Inappropriate schedule of product administration
Clinical narrative: Theagent reports, the consumer is "over due" for her third dose of GARDASIL 9.; No additional AE was reported; This spontaneous report was received from a consumer, referring to herself, a female patient of unknown age.  The patient's medical history, concurrent conditions and concomitant therapies were not reported.  On an unspecified date, the patient was vaccinated with the first and second dose of human papillomavirus (hpv) rl1 6 11 16 18 31 33 45 52 58 VLP vaccine (yeast) (GARDASIL 9) for prophylaxis (strength, dose description, lot #, expiry date, and route of administration were not provided).  On an unspecified date, the patient was "over due" for her third dose of (hpv) rl1 6 11 16 18 31 33 45 52 58 VLP vaccine (yeast) (GARDASIL 9) (Inappropriate schedule of product administration) and her pharmacist told her that she was supposed to have it done at that time. No additional adverse events were reported.
Sex: U
Vaccine: VARCEL
Symptoms: Product storage error
Clinical narrative: no adverse event; a dose of VARIVAX was administered to the patient on 10AUG2022 after experiencing a temperautre excursion; This spontaneous report was received from a medical assistant and refers to a patient of unknown age and gender.  The patient's medical history, concurrent conditions, and concomitant therapies were not reported.  On 10-AUG-2022, the patient was vaccinated with an improperly stored dose of varicella virus vaccine live (oka/merck) (VARIVAX) 0.5 milliliter, lot #U026207, expiration date: 24-AUG-2023 (strength, dosage regimen, anatomical location, and route of administration were not provided) as prophylaxis. It was reported that the vaccine underwent a temperature excursion of 18.6 Fahrenheit degrees for 30 minutes, with a previous temperature excursion of 9.8 Fahrenheit degrees for 30 minutes (product storage error). No adverse event was reported.  This is one of several cases reported by the same reporter.
Sex: U
Vaccine: VARZOS
Symptoms: Herpes zoster, Vaccination failure
Clinical narrative: had the shots, dealing with shingles/ Suspected Vaccination Failure; shingles for over 5 months; This case was reported by a consumer via interactive digital media and described the occurrence of vaccination failure in a patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   The patient's past medical history included covid-19 (had Covid).   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 was unknown and the outcome of the shingles was not recovered/not resolved.   It was unknown if the reporter considered the vaccination failure and shingles to be related to Shingles vaccine.     Additional Information: GSK Receipt Date: 08-AUG-2022 Reporter's Comment: This case was reported by a patient via interactive digital media. The patient stated that, he/she agreed and there were studies now that, claim if you had Covid, you had a higher risk of getting shingles.  The patient had the Shingles shots and he/she was now dealing with shingles for over 5 months. Additional Supportive Information: This case was considered as suspected vaccination failure as details regarding completion of primary vaccination schedule, time to onset and laboratory test confirming shingles were unknown at the time of reporting. The follow up would not possible as no contact details were available.
Sex: M
Vaccine: VARZOS
Symptoms: Herpes zoster, Vaccination failure
Clinical narrative: My husband got it three times after the shot/Suspected vaccination failure; Got it three times; This case was reported by a consumer via interactive digital media and described the occurrence of vaccination failure in a male 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 Information: GSK Receipt Date: 09-AUG-2022 Reporter's Comment: This case was reported by a patient's wife via interactive digital media. The reporter stated that, did not get the shingles shot. The patient got the shingles shot and had shingles three times after the shot. Additional Supportive Information: This case was considered as suspected vaccination failure as details regarding completion of primary vaccination schedule ,time to onset and laboratory test confirming shingles were unknown at the time of reporting. The follow up would not possible as no contact details were available.
Sex: F
Vaccine: VARZOS
Symptoms: Death, Herpes zoster, Neoplasm, Vaccination failure
Clinical narrative: took vaccine, died 3 months later; got shingles after vaccine/Suspected vaccination failure; got shingles after vaccine; got tumor after vaccine; This case was reported by a consumer via interactive digital media and described the occurrence of unknown cause of death in a female patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   On an unknown date, the patient received Shingles vaccine. On an unknown date, 3 months after receiving Shingles vaccine, the patient experienced unknown cause of death (serious criteria death and GSK medically significant), vaccination failure (serious criteria GSK medically significant), shingles and neoplasm. On an unknown date, the outcome of the unknown cause of death was fatal and the outcome of the vaccination failure, shingles and neoplasm were unknown. The reported cause of death was unknown cause of death.   It was unknown if the reporter considered the unknown cause of death, vaccination failure, shingles and neoplasm to be related to Shingles vaccine.   Additional Information: GSK Receipt Date: 11-AUG-2022 Reporter's Comment: This case was reported by a patient's friend via interactive digital media. The patient took shingles vaccine. The patient got shingles and tumor after taking the vaccine. The patient died three months later. Additional Supportive Information: This case was considered as suspected vaccination failure as details regarding completion of primary vaccination schedule, time to onset and laboratory test confirming shingles were unknown at the time of reporting. The follow up would not possible as no contact details were available. Time to onset for event unknown cause of death was conservatively captured as 3 months as it was not clear if it was after vaccination or other events.; Reported Cause(s) of Death: Unknown cause of death
Sex: U
Vaccine: VARZOS
Symptoms: Cancer screening, Fatigue, Herpes zoster, Laboratory test, Nerve injury
Clinical narrative: Shingles 4 years ago, i was vaccinated/Suspected vaccination failure; Shingles 4 years ago; I was exausted, many test,x rays,suspicious cancer; Damage nerves; Pain treatments, killed nerves, and still in such a pain; This case was reported by a consumer via interactive digital media and described the occurrence of 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), shingles, exhaustion, nerve damage and pain. The patient was treated with analgesic, nos (Pain Medication). On an unknown date, the outcome of the vaccination failure, shingles, exhaustion and nerve damage were unknown and the outcome of the pain was not recovered/not resolved.   It was unknown if the reporter considered the vaccination failure, shingles, exhaustion, nerve damage and pain to be related to Shingles vaccine.  Additional Information: GSK Receipt Date: 08-AUG-2022 Reporter's Comment: This case was reported by a patient via interactive digital media. The patient was vaccinated with shingles vaccine.  The patient stated that, after many years test, x-rays, suspicious cancer test etc. the patient went to a neurologist because he/she was exhausted. The doctor told him/her that, it was shingles 4 years ago, but rash never came out damage nerves, he/she went to pain treatments, killed nerves and still in such a pain that he/she really dealing every day. The patient was working and doing the best he/she could. The medication was not enough to calm it down. The patient was praying for the people who had it and did not know. Additional Supportive Information: This case was considered as suspected vaccination failure as details regarding completion of primary vaccination schedule, time to onset and laboratory test confirming shingles were unknown at the time of reporting. The follow up would not possible as no contact details were available.
Sex: U
Vaccine: VARZOS
Symptoms: Neurological examination abnormal, Pain, Vaccination failure, X-ray
Clinical narrative: Shingles 4 years ago, i was vaccinated/Suspected vaccination failure; Shingles 4 years ago; I was exausted, many test,x rays,suspicious cancer; Damage nerves; Pain treatments, killed nerves, and still in such a pain; This case was reported by a consumer via interactive digital media and described the occurrence of 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), shingles, exhaustion, nerve damage and pain. The patient was treated with analgesic, nos (Pain Medication). On an unknown date, the outcome of the vaccination failure, shingles, exhaustion and nerve damage were unknown and the outcome of the pain was not recovered/not resolved.   It was unknown if the reporter considered the vaccination failure, shingles, exhaustion, nerve damage and pain to be related to Shingles vaccine.  Additional Information: GSK Receipt Date: 08-AUG-2022 Reporter's Comment: This case was reported by a patient via interactive digital media. The patient was vaccinated with shingles vaccine.  The patient stated that, after many years test, x-rays, suspicious cancer test etc. the patient went to a neurologist because he/she was exhausted. The doctor told him/her that, it was shingles 4 years ago, but rash never came out damage nerves, he/she went to pain treatments, killed nerves and still in such a pain that he/she really dealing every day. The patient was working and doing the best he/she could. The medication was not enough to calm it down. The patient was praying for the people who had it and did not know. Additional Supportive Information: This case was considered as suspected vaccination failure as details regarding completion of primary vaccination schedule, time to onset and laboratory test confirming shingles were unknown at the time of reporting. The follow up would not possible as no contact details were available.
Sex: U
Vaccine: VARZOS
Symptoms: Herpes zoster, Post herpetic neuralgia, Vaccination failure
Clinical narrative: had the new shingles shot/ had shingles/suspected vaccination failure; Sine Shingles; Nerve pain; This case was reported by a consumer via interactive digital media and described the occurrence of 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), shingles and post herpetic neuralgia. On an unknown date, the outcome of the vaccination failure, shingles and post herpetic neuralgia were unknown.   It was unknown if the reporter considered the vaccination failure, shingles and post herpetic neuralgia to be related to Shingles vaccine.     Additional Information: GSK Receipt Date: 08-AUG-2022 Reporter's Comment: This case was reported by a patient via interactive digital media. The patient stated that, not always, he/she had since shingles. The patient had no rash because he/she had the new shingles shot. The patient further stated that, you might get the nerve pain but if caught quickly enough and not the rash. The patient still did 10 days on stereos (unspecified) to knock down the virus. Additional Supportive Information: This case was considered as suspected vaccination failure as details regarding completion of primary vaccination schedule, time to onset and laboratory test confirming shingles 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: COVID-19, Herpes zoster, Vaccination failure
Clinical narrative: had both shots, got shingles/Suspected vaccination failure; shingles; got covid; This case was reported by a consumer via interactive digital media 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 (the patient had shingles four times). Concurrent medical conditions included hepatitis c (The patient had hepatitis C since 1987).   On an unknown date, the patient received the 2nd dose of Shingles vaccine and the 1st 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), shingles and covid-19. On an unknown date, the outcome of the vaccination failure, shingles and covid-19 were unknown.   It was unknown if the reporter considered the vaccination failure, shingles and covid-19 to be related to Shingles vaccine and Shingles vaccine.     Additional Information: GSK Receipt Date: 31-JUL-2022 Reporter's Comment: This case was reported by a patient via interactive digital media. The patient had shingles fourth times and finally had both shingles shots but after he/she got covid and shingles again. The patient had hepatitis C since 1987. The patient's doctor figured that, it was because he/she had a virus living in his/her for so many years.  The patient stated that, they were surprised and got them again.  The patient further stated that, best of luck to everyone else though. Additional Supportive Information: This case was considered as suspected vaccination failure as details regarding completion of primary vaccination schedule, time to onset and laboratory test confirming shingles were unknown at the time of reporting. The follow up would not possible as no contact details were available.
Sex: F
Vaccine: VARZOS
Symptoms: Dizziness, Hypotension, Nausea
Clinical narrative: Low blood pressure (80/40); Felt like she was going to throw up; Felt like she was going to faint/ passout; This case was reported by a consumer via call center representative and described the occurrence of low blood pressure in a adult female patient who received Herpes zoster (Shingrix) for prophylaxis.   On an unknown date, the patient received the 1st dose of Shingrix. On an unknown date, less than a day after receiving Shingrix, the patient experienced low blood pressure, nausea and felt faint. On an unknown date, the outcome of the low blood pressure, nausea and felt faint were unknown.   It was unknown if the reporter considered the low blood pressure, nausea and felt faint to be related to Shingrix.     Additional Information: GSK Receipt Date: 08-Aug-2022 Reporter's comment: The patient had a frightening response to first Shingrix vaccination. The patient stated that she received her 1st dose of Shingrix about 6 months ago.  The patient stated that within 24 hours after receiving her first dose of Shingrix, she experienced low blood pressure (80/40), felt like she was going to throw up, and she felt like she was going to faint/passout. The patient declined to provide further contact information.
Sex: U
Vaccine: VARZOS
Symptoms: Accidental exposure to product, Exposure via skin contact, Underdose
Clinical narrative: Second shot botched, vaccine ran down arm; Vaccine ran down arm to elbow; Vaccine ran down arm to elbow; This case was reported by a consumer via interactive digital media and described the occurrence of accidental underdose 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, unknown after receiving Shingrix, the patient experienced accidental underdose, inadvertent exposure to vaccine and exposure via skin contact. On an unknown date, the outcome of the accidental underdose, inadvertent exposure to vaccine and exposure via skin contact were unknown.     Additional Information: GSK Receipt Date: 06-AUG-2022 Reporter's Comments:  This case was reported by consumer (patient) via interactive digital media. The patient had second shot of shingrix was botched as the needle became loose from the syringe and some of the vaccine ran down to patient's arm to elbow.  The pharmacist suggested to patient to get a third shot in 2-6 months.  The patient had no idea how much vaccine got into the arm. Additional Supportive Information: While administrating the 2nd shot of the Shingrix vaccine to a patient some of the vaccine ran down to patient's arm to elbow, but no idea how much vaccine got into the arm, which led to accidental underdose, exposure via skin contact and inadvertent exposure to vaccine.
Sex: U
Vaccine: VARZOS
Symptoms: Feeling abnormal, Mobility decreased
Clinical narrative: can't lift it high/reach around my back; This case was reported by a consumer via interactive digital media and described the occurrence of mobility decreased in a patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   The patient's past medical history included shingles (had before).   In June 2022, the patient received Shingles vaccine. On an unknown date, less than 2 months after receiving Shingles vaccine, the patient experienced mobility decreased. On an unknown date, the outcome of the mobility decreased was unknown.   It was unknown if the reporter considered the mobility decreased to be related to Shingles vaccine.     Additional Information: GSK Receipt Date: 07-AUG-2022 Reporter's Comments: This case reported by the patient via interactive digital media. The patient got his or her shot 2 months ago of reporting date and he or she could not lift it high or reach around his or her back. It was miserable.  Additional Supportive Information: Follow-up would not possible as no contact details were available.
Sex: U
Vaccine: VARZOS
Symptoms: Limb discomfort
Clinical narrative: my arm is killing me; This case was reported by a consumer via interactive digital media and described the occurrence of arm discomfort in a patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   On 6th August 2022, the patient received the 1st dose of Shingles vaccine. In August 2022, less than a week after receiving Shingles vaccine, the patient experienced arm discomfort. On an unknown date, the outcome of the arm discomfort was not recovered/not resolved.   It was unknown if the reporter considered the arm discomfort to be related to Shingles vaccine.     Additional Information: GSK Receipt Date: 07-AUG-2022 Reporter's Comments: This case reported by the patient via interactive digital media. The patient just got 1st shot and his or her arm was killing him or her. Additional Supportive Information: Follow-up would not possible as no contact details were available.
Sex: U
Vaccine: VARZOS
Symptoms: Paraesthesia oral
Clinical narrative: tingling around the bottom lip, chin area; This case was reported by a consumer via interactive digital media and described the occurrence of tingling in a patient who received Herpes zoster (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 tingling. On an unknown date, the outcome of the tingling was unknown.   It was unknown if the reporter considered the tingling to be related to Shingrix.     Additional Information: GSK Receipt Date: 08-Aug-2022 Reporter's comment: This case was reported by the consumer via interactive digital media. The reporter stated that Shingrix first shot and asked whether it could cause tingling around the bottom lip, chin area. Additional Supportive Information: Follow-up would not possible as no contact details were available.
Sex: U
Vaccine: VARZOS
Symptoms: Pain in extremity
Clinical narrative: Arm was sore for days better that than shingles; This case was reported by a consumer via interactive digital media and described the occurrence of pain in arm in a patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   On an unknown date, the patient received the 1st dose of Shingles vaccine. On an unknown date, several weeks after receiving Shingles vaccine, the patient experienced pain in arm. On an unknown date, the outcome of the pain in arm was recovered/resolved.   It was unknown if the reporter considered the pain in arm to be related to Shingles vaccine.     Additional Information: GSK Receipt Date: 29-JUL-2022 Reporter's Comments: The case was received from the patient via interactive digital media. The patient got first shot a few weeks ago from reporting and his/her arm was sore for days better that than shingles.  The patient's second shot on the 22nd (unspecified). Additional Supportive Information: Follow-up would not possible as no contact details were available.
Sex: F
Vaccine: VARZOS
Symptoms: Incomplete course of vaccination
Clinical narrative: received 1st dose on Jan2019, wants to receive 2nd today (08Aug2022); This case was reported by a pharmacist via call center representative and described the occurrence of incomplete course of vaccination in a adult female patient who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included Shingrix (received 1st dose on January 2019).   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 Information: GSK Receipt Date: 08-AUG-2022 Reporter's Comments: The pharmacist reported that the patient wanted to receive 2nd dose but unknown if patient received 2nd Shingrix at time of reporting. The reporter was consented to follow up. Additional supportive information: Till the time of reporting it was unknown if patient received 2nd dose of shingrix which led to incomplete course of vaccination.
Sex: U
Vaccine: VARZOS
Symptoms: Incomplete course of vaccination
Clinical narrative: At the time of the report, the patient has not yet received the second dose in the series; This case was reported by a pharmacist via call center representative and described the occurrence of incomplete course of vaccination in a patient who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included Shingrix (1st dose of Shingrix received in 2018).   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 Information: GSK receipt date: 10-Aug-2022 Reporter comment: The pharmacist reported that patient received first dose of Shingrix and now wanted the second dose. At the time of the report, the patient had not yet received the second dose in the series. Additional Supportive Information: Till the time of reporting, the patient did not receive the 2nd dose, which led to incomplete course of vaccination.
Age: 16.0
Sex: F
Vaccine: MNQ
Symptoms: Incorrect dose administered, Product preparation issue
Clinical narrative: administration of Menveo diluent portion only; administration of Menveo diluent portion only; This case was reported by a nurse via call center representative and described the occurrence of inappropriate preparation of medication in a 16-year-old female patient who received Men ACWY-CRM NVS (Menveo) (batch number AMXA653A, expiry date 30th June 2023) for prophylaxis.   On 10th August 2022, the patient received Menveo. On 10th August 2022, unknown after receiving Menveo, the patient experienced inappropriate preparation of medication and inappropriate dose of vaccine administered. On an unknown date, the outcome of the inappropriate preparation of medication and inappropriate dose of vaccine administered were unknown.  Additional Information: GSK Receipt Date: 10-Aug-2022. Reporter's Comments: The registered nurse (RN) reported that the patient administered with Menveo diluent portion only. The reporter (HCP) reported that patient just had a baby as well. The reporter consented to follow up. Additional Supportive Information: The administration of Menveo diluent portion only, which led to inappropriate preparation of medication and inappropriate dose of vaccine administered.
Age: 13.0
Sex: M
Vaccine: HEPA
Symptoms: Overdose, Product administered to patient of inappropriate age
Clinical narrative: 13 year old received the adult dose of Havrix; 13 year old received the adult dose of Havrix; This case was reported by a other health professional via call center representative and described the occurrence of overdose in a 13-year-old male patient who received HAV (Havrix adult) (batch number H4H53, expiry date 30th January 2023) for prophylaxis.   Co-suspect products included hepatitis A vaccine pre-filled syringe device (Havrix Pre-Filled Syringe Device) injection syringe for prophylaxis.   On 10th August 2022, the patient received Havrix adult and Havrix Pre-Filled Syringe Device. On 10th August 2022, unknown after receiving Havrix adult and Havrix Pre-Filled Syringe Device, the patient experienced overdose and adult product administered to child. On an unknown date, the outcome of the overdose and adult product administered to child 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 Information: GSK Receipt Date: 10-Aug-2022 Reporter's Comments: The reporter stated that a 13 year old patient received the adult dose of Havrix. No reactions were reported. The reporter consented to follow up via email.  The Vaccine Administration Facility is the same as Primary Reporter. Additional Supportive Information: The 13 year old patient received the adult dose of Havrix, which led to adult product administered to child and overdose.