chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 34.0
Sex: F
Vaccine: COVID19
Symptoms: Nausea, Pain, Pain in extremity, Pyrexia, Rhinorrhoea
Clinical narrative: 1700- Dizziness, Headache, Sweating, Tachypnea  By 2000 - Headache, Body Aches, Fatigue, Abdominal Pain, Muscle Twinges, Chills, Rigors, Fever 101 F- with Acetaminophen and Ibuprofen, Chest Pain, SOB, Weakness, Arm Pain, Nausea, Runny Nose  Day Two - Lethargy, Headache, Fever, Body Aches, SOB, Calf Pain, Abdominal Pain, Nausea  Day Three - Abdominal Pain, Muscle Twinges, Nose Bleed, Calf Pain, Lethargy, Headache, Arm Pain, SOB, Back Pain, Ears Ringing Day Four - Diarrhea, Abdominal Pain, Calf Pain, Weakness, Muscle Twinges, Arm Pain, Fatigue - Brain Fog?, SOB, Headache, Back Pain  ...... Onto Day 9 (Current Day) - Calf Pain, Muscle Twinges, Headache, Arm Pain, Weakness
Age: 34.0
Sex: F
Vaccine: COVID19
Symptoms: Tachypnoea, Tinnitus
Clinical narrative: 1700- Dizziness, Headache, Sweating, Tachypnea  By 2000 - Headache, Body Aches, Fatigue, Abdominal Pain, Muscle Twinges, Chills, Rigors, Fever 101 F- with Acetaminophen and Ibuprofen, Chest Pain, SOB, Weakness, Arm Pain, Nausea, Runny Nose  Day Two - Lethargy, Headache, Fever, Body Aches, SOB, Calf Pain, Abdominal Pain, Nausea  Day Three - Abdominal Pain, Muscle Twinges, Nose Bleed, Calf Pain, Lethargy, Headache, Arm Pain, SOB, Back Pain, Ears Ringing Day Four - Diarrhea, Abdominal Pain, Calf Pain, Weakness, Muscle Twinges, Arm Pain, Fatigue - Brain Fog?, SOB, Headache, Back Pain  ...... Onto Day 9 (Current Day) - Calf Pain, Muscle Twinges, Headache, Arm Pain, Weakness
Age: 52.0
Sex: F
Vaccine: COVID19
Symptoms: Abdominal discomfort, Extra dose administered, Fatigue, Headache, Injection site erythema
Clinical narrative: covid arm swelling, raised hard red skin around injection site Very very itchy  otherwise I experience achey body, headache, fatique, upset stomach Did not experience any of this with first 2 doses.  Only with booster. Im still glad I got it.
Age: 52.0
Sex: F
Vaccine: COVID19
Symptoms: Injection site induration, Injection site swelling, Pain, Peripheral swelling, Pruritus
Clinical narrative: covid arm swelling, raised hard red skin around injection site Very very itchy  otherwise I experience achey body, headache, fatique, upset stomach Did not experience any of this with first 2 doses.  Only with booster. Im still glad I got it.
Age: 52.0
Sex: F
Vaccine: COVID19
Symptoms: Vaccination site reaction
Clinical narrative: covid arm swelling, raised hard red skin around injection site Very very itchy  otherwise I experience achey body, headache, fatique, upset stomach Did not experience any of this with first 2 doses.  Only with booster. Im still glad I got it.
Age: 40.0
Sex: F
Vaccine: COVID19
Symptoms: Cardiac flutter, Fatigue, Myalgia
Clinical narrative: Flutter in the heart every now and then Tired Muscular Pain
Age: 34.0
Sex: M
Vaccine: COVID19
Symptoms: Ageusia, COVID-19, Chest discomfort, Chills, Cough
Clinical narrative: From the date of his vaccine til the date he  went to the hospital (August 22, 2021) he felt these symptoms more and more. Soar arm, chills, body aches, fatigue, fever, lost of taste, cough, shortness of breath, excessive sweating, heavy chest, couldn?t walk or use legs, couldn?t urinate after drinking water. He took  Advil(red pill). He died August 23, 2021
Age: 34.0
Sex: M
Vaccine: COVID19
Symptoms: Death, Dyspnoea, Fatigue, Gait inability, Hyperhidrosis
Clinical narrative: From the date of his vaccine til the date he  went to the hospital (August 22, 2021) he felt these symptoms more and more. Soar arm, chills, body aches, fatigue, fever, lost of taste, cough, shortness of breath, excessive sweating, heavy chest, couldn?t walk or use legs, couldn?t urinate after drinking water. He took  Advil(red pill). He died August 23, 2021
Age: 34.0
Sex: M
Vaccine: COVID19
Symptoms: Pain, Pain in extremity, Pyrexia, SARS-CoV-2 test positive, Urinary retention
Clinical narrative: From the date of his vaccine til the date he  went to the hospital (August 22, 2021) he felt these symptoms more and more. Soar arm, chills, body aches, fatigue, fever, lost of taste, cough, shortness of breath, excessive sweating, heavy chest, couldn?t walk or use legs, couldn?t urinate after drinking water. He took  Advil(red pill). He died August 23, 2021
Age: 61.0
Sex: F
Vaccine: COVID19
Symptoms: Injection site pain, Injection site swelling
Clinical narrative: Moderna COVID?19 Vaccine EUA Significant Pain and Swelling at injection site starting approx 6 hours after injection. I took 200mg Aleve tablet at 12 hours after injection
Sex: U
Vaccine: MMRV
Symptoms: No adverse event, Product storage error
Clinical narrative: no additionalAE's reported; temperature excursion/ vaccine given to patient; This spontaneous report as received from a medical assistant and refers to a patient of unknown age and gender. No information regarding the patient's pertinent medical history, drug reactions or allergies and concomitant therapies was provided.  On an unknown date between 29-AUG-2021 and 30-AUG-2021, the temperature excursion of the stored measles, mumps, rubella and varicella (oka-merck) virus vaccine live (PROQUAD) (lot # U002533, expiration date 24-JUL-2022) was 8.7 Fahrenheit degree (F) for a time frame of 19 hours and 12 minutes. There was no previous temperature excursion. On 16-SEP-2021, the patient was vaccinated with an improperly stored 1 dose of measles, mumps, rubella and varicella (oka-merck) virus vaccine live (PROQUAD) albumin status rHA, lot # U002533, expiration date 24-JUL-2022 (route of administration were not reported) for prophylaxis. The patient did not report symptoms after the administration of the vaccine. No additional adverse events were reported.  This is one of two reports received from the same reporter.; Sender's Comments:  US-009507513-2110USA003187:
Age: 34.0
Sex: U
Vaccine: HPV9
Symptoms: Expired product administered, No adverse event
Clinical narrative: no additional adverse experience reported; an expired dose of Gardasil 9 was administered to a patient; This spontaneous report was received from an other healthcare professional and refers to a 34-year-old patient of unknown gender. No information regarding the patient's pertinent medical history, drug reactions, allergies and concomitant medications.  On 04-OCT-2021, the patient was vaccinated with an expired dose of hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast) (GARDASIL 9) lot # R032766, expiration date 31-AUG-2021, 1 single dose for prophylaxis. No additional adverse experience reported.
Sex: U
Vaccine: MMRV
Symptoms: No adverse event, Product storage error
Clinical narrative: no additionalAE's reported; temperature excursion/ vaccine given to patient; This spontaneous report as received from a medical assistant and refers to a patient of unknown age and gender. No information regarding the patient's pertinent medical history, drug reactions or allergies and concomitant therapies was provided.  On an unknown date between 29-AUG-2021 and 30-AUG-2021, the temperature excursion of the stored measles, mumps, rubella and varicella (oka-merck) virus vaccine live (PROQUAD) (lot # U007506, expiration date 04-SEP-2022) was 8.7 Fahrenheit degree (F) for a time frame of 19 hours and 12 minutes. There was no previous temperature excursion. On 23-SEP-2021, the patient was vaccinated with an improperly stored 1 dose of measles, mumps, rubella and varicella (oka-merck) virus vaccine live (PROQUAD) albumin status rHA, lot # U007506, expiration date 04-SEP-2022 (route of administration were not reported) for prophylaxis. The patient did not report symptoms after the administration of the vaccine. No additional adverse events were reported.  This is one of two reports received from the same reporter.; Sender's Comments:  US-009507513-2110USA000390:
Age: 42.0
Sex: F
Vaccine: MMR, TDAP, UNK, UNK, UNK
Symptoms: Pain in extremity
Clinical narrative: has been having excruciating pain in her arm; none help alleviate it; This spontaneous report was received from a 42 years old female patient referring to herself. The patient's pertinent medical history included unspecified thyroid problem and concomitant medication included unspecified thyroid medication. The patient had none drug reactions or allergies.  On 25-SEP-2021, the patient was vaccinated with measles, mumps, and rubella (wistar ra 27-3) virus vaccine, live (M-M-R II) (strength, dose, route, lot# and expiration date were unknown) and diphtheria vaccine toxoid (+) pertussis vaccine acellular 5-component (+) tetanus vaccine toxoid (ADACEL) (strength, dose, route, lot# and expiration date were unknown) in right arm for immigration purposes (prophylaxis).  On 25-SEP-2021 (also reported as since then), the patient has been having excruciating pain in her arm. Both vaccines were administered in her right arm, which was her dominant arm. The patient was unsure which vaccines was causing her the pain. In approximately 2021, the patient has tried paracetamol (ACETAMINOPHEN), ibuprofen and naproxen for pain as well as ice packs and none help alleviate it (Drug ineffective). The patient was administered the vaccine at a local pharmacy and not at her physician's office. The pharmacy staff recommended the patient contact the manufacturer of the vaccine. Referred the patient to her healthcare provider for recommendations. Agreed to schedule an appointment soon. The patient had already received all of the required vaccines at a young age, but she does not have her childhood immunization record and therefore, immigration was requiring she be re-vaccinated. No medical attention was sought. Action taken with paracetamol (ACETAMINOPHEN), ibuprofen and naproxen was not reported. The outcome of pain in arm was not recovered. The outcome of drug ineffective was not reported. The causality assessment was not provided.
Age: 1.0
Sex: U
Vaccine: VARCEL
Symptoms: No adverse event, Product storage error
Clinical narrative: No additional AE details available; vaccines were administered after experiencing temperature excursion.; This spontaneous report was received from a medical assistant and refers to a 12-month-old patient of unknown gender. The patient's pertinent medical history, drug reactions, allergies and concomitant medication were not reported.  On 07-OCT-2021 the patient was vaccinated with with improperly stored dose of varicella virus vaccine live (Oka/Merck) (VARIVAX), lot # T032317 was confirmed to be valid with expiration date 22-SEP-2022 (dose, route of administration, anatomical location were not reported) for prophylaxis. The administered dose underwent a temperature excursion of 8.5 degrees Fahrenheit (F) for 18 minutes and 11.9 F for 1 hour. There were no previous temperature excursions. No additional adverse effect was reported.  This is one of two reports received from the same reporter.; Sender's Comments:  US-009507513-2110USA007766:
Age: 2.0
Sex: U
Vaccine: VARCEL
Symptoms: No adverse event, Product storage error
Clinical narrative: No additional AE details available; vaccines were administered after experiencing temperature excursion.; This spontaneous report was received from a medical assistant and refers to a 2-year-old patient of unknown gender. The patient's pertinent medical history, drug reactions, allergies and concomitant medication were not reported.  On 21-OCT-2021 the patient was vaccinated with with improperly stored dose of varicella virus vaccine live (Oka/Merck) (VARIVAX), lot # T032932 was confirmed to be valid with expiration date 28-SEP-2022 (dose, route of administration, anatomical location were not reported) for prophylaxis. The administered dose underwent a temperature excursion of 8.5 degrees Fahrenheit (F) for 18 minutes and 11.9 F for 1 hour. There were no previous temperature excursions. No additional adverse effect was reported.  This is one of two reports received from the same reporter.; Sender's Comments:  US-009507513-2110USA007759:
Sex: F
Vaccine: VARZOS
Symptoms: Dementia
Clinical narrative: Dementia; This case was reported by a consumer via (GSK Patient Assistance Program) patient support programs and described the occurrence of dementia in a 80-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   On an unknown date, the patient received Shingrix. On an unknown date, unknown after receiving Shingrix, the patient experienced dementia (serious criteria GSK medically significant). On an unknown date, the outcome of the dementia was not recovered/not resolved.   The reporter considered the dementia to be unrelated to Shingrix.  Additional details were reported as follows: The case was reported by the patient's spouse. The age at vaccination was not reported. The patient's spouse called because the patient got denied and mentioned that the patient had dementia (no further details provided).  The reporter did not provide batch number/ lot number and expiry date. Unable to ask questions because the reporter did not want to respond, was mad about denial reasons and hung up call. The reporter did not consent to follow up.
Sex: U
Vaccine: FLUX, PPV, VARZOS
Symptoms: Pain in extremity
Clinical narrative: 2 sore arms; 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.   Co-suspect products included Flu Seasonal QIV Dresden (Influenza vaccine Quadrivalent unspecified season) for prophylaxis and PNEUMOCOCCAL VACCINE (PNEUMONIA VACCINE) for prophylaxis.   On an unknown date, the patient received Shingles vaccine, Influenza vaccine Quadrivalent unspecified season and PNEUMONIA VACCINE. On an unknown date, unknown after receiving Shingles vaccine and Influenza vaccine Quadrivalent unspecified season, the patient experienced pain in arm. On an unknown date, the outcome of the pain in arm was unknown.   It was unknown if the reporter considered the pain in arm to be related to Shingles vaccine and Influenza vaccine Quadrivalent unspecified season.  Additional details were provided as follows: The patient self-reported this case. The age at vaccination was not reported. The patient received Flu shot, shingles vaccine and pneumonia vaccine and experienced 2 sore arm. It was unknown if the reporter considered the pain in arm to be related to PNEUMOCOCCAL VACCINE . This case was linked with the case US2021AMR219073, reported by same reporter.; Sender's Comments:  US-GLAXOSMITHKLINE-US2021AMR219073:Same reporter
Sex: F
Vaccine: FLUX
Symptoms: Paraesthesia
Clinical narrative: tingling all over and on her face; This case was reported by a consumer via other manufacturer and described the occurrence of tingling in a 80-year-old female patient who received Flu Seasonal QIV Dresden (Influenza vaccine Quadrivalent unspecified season) for prophylaxis.   Concurrent medical conditions included thyroid disorder, glaucoma and drug allergy (gets rashes from certain medications like Macrobid and gets severe diarrhea from certain antibiotics like Ampicillin, contrast dye if taken orally). Additional patient notes included Ethnicity. Concomitant products included levothyroxine sodium (Synthroid) and vitamins nos (Vitamin Supplement).   On an unknown date, the patient received Influenza vaccine Quadrivalent unspecified season. On an unknown date, unknown after receiving Influenza vaccine Quadrivalent unspecified season, the patient experienced tingling. On an unknown date, the outcome of the tingling was recovered/resolved.   It was unknown if the reporter considered the tingling to be related to Influenza vaccine Quadrivalent unspecified season.  Additional details were provided as follows: This case was reported by the patient herself. The age at vaccination was not reported. The patient had allergy from certain medications like Macrobid and got rashes and got severe diarrhea from certain antibiotics like Ampicillin, contrast dye if taken orally and hence had to take it by intravenous route. Concomitant medications included Synthroid, Lumigen drops one drop each daily for glaucoma, and other vitamins and supplements that she had been on for 10 years. The patient was very healthy, she walked and did not have any issues with her. The patient had received the Flu vaccine in 2018 and experienced tingling like the same thing that happened with this vaccine.  She did not had a manufacturer, lot or expiration for it.
Age: 13.0
Sex: F
Vaccine: HPVX
Symptoms: Menstruation delayed
Clinical narrative: menstruation cycle delay; This case was reported by a consumer via interactive digital media and described the occurrence of menstruation delayed in a 13-year-old female patient who received HPV 16-18 (HPV vaccine) for prophylaxis.   On 3rd October 2021, the patient received the 1st dose of HPV vaccine. On an unknown date, less than 3 weeks after receiving HPV vaccine, the patient experienced menstruation delayed. On an unknown date, the outcome of the menstruation delayed was unknown.   It was unknown if the reporter considered the menstruation delayed to be related to HPV vaccine.  Additional details were provided as follows: This case was reported by patient's parent. The patient was vaccinated with 1st dose of Human Papillomavirus vaccine first dose on 3rd October 2021and now her menstruation cycle delayed 15 days. The last menstruation cycle was on 5th September 2021.  The patient's parent had a doubt that was there any relationship between HPV vaccination and menstruation delayed and requested to clear his/her doubt.
Sex: U
Vaccine: VARZOS
Symptoms: Incomplete course of vaccination
Clinical narrative: had the first shingrix but not the second; This case was reported by a consumer via interactive digital media 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 received on an unknown 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. The patient had 1st dose of Shingrix shot but not the second dose till the time of reporting, which led incomplete course of vaccination. The question was asked did need to start over with the first shot of Shingrix. The follow-up would not possible as no contact details were available.
Sex: U
Vaccine: VARZOS
Symptoms: Herpes zoster, Vaccination failure
Clinical narrative: suspected vaccination failure; shingles; This case was reported by a consumer viainteractive digital 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 had reported for him/herself. The age at vaccination was not reported. After receiving Shingles vaccine, the patient still got shingles. This case was considered as suspected vaccination failure, since the details regarding the completion of the primary immunization, time to onset for event and laboratory confirmation of shingles were not provided.
Sex: U
Vaccine: VARZOS
Symptoms: Herpes zoster, Somnolence, Vaccination failure
Clinical narrative: suspected vaccination failure; got it; All I did was sleep; This case was reported by a consumer via interactive digital 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), shingles and sleepiness. On an unknown date, the outcome of the vaccination failure and shingles were unknown and the outcome of the sleepiness was recovered/resolved.   It was unknown if the reporter considered the vaccination failure, shingles and sleepiness to be related to Shingles vaccine.  Additional details were provided as follows: The patient had reported for him/herself. The age at vaccination was not reported. After receiving Shingles vaccine, the patient still got shingles. The patient stated that, all he/she did was sleep. This case was considered as suspected vaccination failure, since the details regarding the completion of the primary immunization, time to onset for event and laboratory confirmation of shingles were not provided.
Sex: U
Vaccine: VARZOS
Symptoms: Chemotherapy, Herpes zoster, Kidney infection, Pain, Radiotherapy
Clinical narrative: Kidney infection; I had my shingles shot/ I have the shingles right now/suspected vaccination failure; I have the shingles right now; Pain; This case was reported by a consumer via interactive digital media and described the occurrence of suspected vaccination failure and  kidney infection in a patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   The patient's past medical history included infection (patient had 3 infection) and surgery.   On an unknown date, the patient received Shingles vaccine. On an unknown date, unknown after receiving Shingles vaccine, the patient experienced kidney infection (serious criteria GSK medically significant), vaccination failure (serious criteria GSK medically significant), shingles and pain. The patient was treated with non-drug therapy (Radiation Therapy) and chemotherapy, nos (Chemotherapy). On an unknown date, the outcome of the kidney infection, vaccination failure, shingles and pain were unknown.   It was unknown if the reporter considered the kidney infection, vaccination failure, shingles and pain to be related to Shingles vaccine.   Additional details were reported as follows: This case was reported by the patient for himself/herself. The age at vaccination was not reported. The patient had the shingles right now down with them on his/her last radiation therapy Friday. The patient also stated flat in bed do to the pain of them and kidney infection, during chemo and surgery. The patient had 3 infection and asked why not close out with this, and he/she also had shingles shot thank God for my special friend who has been there for he/she. This case was considered as suspected vaccination failure, since the details regarding the completion of primary vaccination schedule and laboratory confirmation for shingles were not provided. The follow up would not possible as contact information was not available.
Sex: U
Vaccine: VARZOS
Symptoms: Vaccination failure
Clinical narrative: Kidney infection; I had my shingles shot/ I have the shingles right now/suspected vaccination failure; I have the shingles right now; Pain; This case was reported by a consumer via interactive digital media and described the occurrence of suspected vaccination failure and  kidney infection in a patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   The patient's past medical history included infection (patient had 3 infection) and surgery.   On an unknown date, the patient received Shingles vaccine. On an unknown date, unknown after receiving Shingles vaccine, the patient experienced kidney infection (serious criteria GSK medically significant), vaccination failure (serious criteria GSK medically significant), shingles and pain. The patient was treated with non-drug therapy (Radiation Therapy) and chemotherapy, nos (Chemotherapy). On an unknown date, the outcome of the kidney infection, vaccination failure, shingles and pain were unknown.   It was unknown if the reporter considered the kidney infection, vaccination failure, shingles and pain to be related to Shingles vaccine.   Additional details were reported as follows: This case was reported by the patient for himself/herself. The age at vaccination was not reported. The patient had the shingles right now down with them on his/her last radiation therapy Friday. The patient also stated flat in bed do to the pain of them and kidney infection, during chemo and surgery. The patient had 3 infection and asked why not close out with this, and he/she also had shingles shot thank God for my special friend who has been there for he/she. This case was considered as suspected vaccination failure, since the details regarding the completion of primary vaccination schedule and laboratory confirmation for shingles were not provided. The follow up would not possible as contact information was not available.
Sex: M
Vaccine: VARZOS
Symptoms: Herpes zoster, Pain, Vaccination failure
Clinical narrative: has them right now and had the vaccine/suspected vaccination failure; has them/ still got them (shingles); there driving him crazy,so painful; This case was reported by a consumer via interactive digital media and described the occurrence of Suspected 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), shingles and pain. On an unknown date, the outcome of the vaccination failure and pain were unknown and the outcome of the shingles was not recovered/not resolved.   It was unknown if the reporter considered the vaccination failure, shingles and pain to be related to Shingles vaccine.   Additional details were reported as follows: This case was reported by the patient's child. The age at vaccination was not reported. The patient had the Shingle vaccine and got shingles and at the time of reporting he still had shingles and there driving him crazy and it was so painful. The follow up would not possible as contact information was not available. This case was considered as suspected vaccination failure, since the details regarding the completion of primary vaccination schedule, time to onset and laboratory confirmation for shingles were not provided.
Sex: M
Vaccine: VARZOS
Symptoms: Herpes zoster, Vaccination failure
Clinical narrative: never got the shingles until a short time after he got the "vaccination/suspected vaccination failure; never got the shingles until a short time after he got the "vaccination; This case was reported by a consumer via interactive digital media and described the occurrence of suspected 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 details were reported as follows: This case was reported by the patients friend. The age at vaccination was not reported. The patient never got the shingles until a short time after he got the vaccination. The reporter asked if it was a coincidence. This case was considered as suspected vaccination failure, since the details regarding the completion of primary vaccination schedule, time to onset and laboratory confirmation for shingles were not provided. The follow up would not possible as contact information was not available.
Sex: F
Vaccine: FLUX
Symptoms: Blood glucose increased, Influenza, Vaccination failure
Clinical narrative: got the Flu shot and ended up having the flu/ suspected vaccination failure; flu; This case was reported by a consumer via other manufacturer and described the occurrence of vaccination failure in a 68-year-old female patient who received Flu unspecified (Influenza vaccine) for prophylaxis.   The patient's past medical history included post-traumatic stress disorder and herpes zoster. Concurrent medical conditions included thyroid disorder, blood cholesterol increased, stress and diabetes. Additional patient notes included White. Concomitant products included metformin, sitagliptin (Januvia), clonidine, rosuvastatine, paroxetine hydrochloride (Paxil), amlodipine, levothyroxine and alprazolam (Xanax).   On an unknown date, the patient received Influenza vaccine. On an unknown date, unknown after receiving Influenza vaccine, the patient experienced vaccination failure (serious criteria GSK medically significant) and influenza. On an unknown date, the outcome of the vaccination failure and influenza were unknown.   It was unknown if the reporter considered the vaccination failure and influenza to be related to Influenza vaccine.  Additional details were provided as follows: The patient self-reported this case. The patient received flu shot and had flu. The patient is taking Metformin 100 mg twice a day for diabetes, Junavia 100 mg once a day for diabetes, Clonidine 0.1 mg for cholesterol, Rovustatin 20 mg for cholesterol, Paxil 1.5 tablets daily, Amlodipine 2.5 mg for blood pressure, Levothyroxine 100 mg once daily, and Xanax. The reporter consented to follow up. This case was considered as suspected vaccination failure as details regarding time to onset and laboratory test confirming flu were unknown at the time of reporting. For tolerance of other flu shot, refer case US2021AMR222561 and for tolerance of Valtrex, refer case US2021AMR221277.; Sender's Comments:  US-GLAXOSMITHKLINE-US2021AMR221277:same reporter US-GLAXOSMITHKLINE-US2021AMR222561:same reporter
Sex: U
Vaccine: VARZOS
Symptoms: Feeling abnormal
Clinical narrative: Both injections, feeling absolute crap; This case was reported by a other health professional via interactive digital media and described the occurrence of feels awful 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, unknown after receiving Shingles vaccine, the patient experienced feels awful. On an unknown date, the outcome of the feels awful was recovered/resolved.   It was unknown if the reporter considered the feels awful to be related to Shingles vaccine.   Additional details were provided as follows: The case was reported by patient. The age at vaccination was not reported. The patient got the shingles vaccine. The shingles vaccine injections made the patient feeling absolute crap for a few days. The patient stated that it was much better than getting shingles. For tolerance of second dose, refer case US2021AMR222528.; Sender's Comments:  US-GLAXOSMITHKLINE-US2021AMR222528:Same reporter.
Sex: U
Vaccine: VARZOS
Symptoms: Incomplete course of vaccination
Clinical narrative: 1st dose a year ago, 2nd late; This case was reported by a consumer via interactive digital media and described the occurrence of incomplete course of vaccination in a patient who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included Shingrix (received 1st dose over an year ago).   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 case was reported by the patient. The age at vaccination was not applicable for this report. Till the time of reporting, the patient did not receive the 2nd dose of Shingrix as per the vaccination schedule, which led to incomplete course of vaccination. The patient was asking what could be done about the 2nd dose.
Sex: U
Vaccine: VARZOS
Symptoms: Incomplete course of vaccination
Clinical narrative: First dose in Jul2019 and forgot about 2nd; This case was reported by a consumer  and described the occurrence of incomplete course of vaccination in a patient who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included Shingrix (received 1st dose in July 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 details were provided as follows: The age at vaccination was not applicable for this report. Till the time of reporting, the patient did not receive the 2nd dose of Shingrix as per the vaccination schedule, which led to incomplete course of vaccination. The patient forgot about the 2nd dose and was asking if need to start series over again or not. The patient was also asking if he/she had any protection from his/her own shot.
Sex: U
Vaccine: VARZOS
Symptoms: Inappropriate schedule of product administration
Clinical narrative: Second dosage two weeks after the first; This case was reported by a consumer via (Shingrix GSK Chatbot) interactive digital media and described the occurrence of drug dose administration interval too short in a patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   Concomitant products included SHINGLES VACCINE (NOS) (SHINGLES VACCINE).   In October 2021, the patient received the 2nd dose of Shingles vaccine. In October 2021, unknown after receiving Shingles vaccine and an unknown time after receiving SHINGLES VACCINE, the patient experienced drug dose administration interval too short. On an unknown date, the outcome of the drug dose administration interval too short was unknown.  Additional details provided were as follows: The case was reported by patient himself/herself. Age at vaccination was not reported. The patient received second dose from drug store two weeks after the first dose, which led to shortening of vaccination schedule. The patient enquired if he/she needed an additional shot. Follow-up would not be possible as no contact details available.
Sex: U
Vaccine: VARZOS
Symptoms: Extra dose administered
Clinical narrative: third Shingrix; This case was reported by a consumer via interactive digital media and described the occurrence of extra dose administered in a patient who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included Shingrix (received 1st and 2nd dose on an unknown date).   In October 2021, the patient received the 3rd dose of Shingrix. In October 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 provided were as follows: The case was self-reported by patient. The age at vaccination was not reported. The patient received 3rd dose of Shingrix because patient forget that he/she already received first and second dose, which led to extra dose administered. Follow-up would not be possible as no contact details available.
Sex: M
Vaccine: VARZOS
Symptoms: Herpes zoster, Vaccination failure
Clinical narrative: suspected vaccination failure; had them; This case was reported by a consumer viainteractive digital media and described the occurrence of suspected 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 details were provided as follows: The case was reported by the patient's wife. The age at vaccination was not reported. The patient received Shingles vaccine years ago from the date of reporting. Last fall from the date of reporting, after receiving Shingles vaccine, the patient got shingles. The reporter stated that, she was really skeptical of all jabs now and asked what they were mixing in with innocent sounding ones. The follow-up would not possible as no contact details were available. This case was considered as suspected vaccination failure, since the details regarding the completion of the primary immunization, time to onset for event and laboratory confirmation for shingles were not provided.
Sex: U
Vaccine: VARZOS
Symptoms: Near death experience
Clinical narrative: I nearly died; This case was reported by a consumer via interactive digital media and described the occurrence of near death experience 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, unknown after receiving Shingles vaccine, the patient experienced near death experience (serious criteria GSK medically significant and life threatening). On an unknown date, the outcome of the near death experience was unknown.   The reporter considered the near death experience to be related to Shingles vaccine.  Additional details were provided as follows: The patient had reported for him/herself. The age at vaccination was not reported. The patient nearly died from the first shot. The patient stated that, he/she would have to suffer with them because could not get the second.
Sex: U
Vaccine: VARZOS
Symptoms: Herpes zoster, Vaccination failure
Clinical narrative: shingles after the shot/ Suspected vaccination failure; shingles; This case was reported by a consumer via  interactive digital 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 self-reported this case. The age at vaccination was not reported. The patient had shingles after Shingles shot. The physician said many people do so. This case was linked with the case US2021AMR224139, reported by same reporter. 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.; Sender's Comments:  US-GLAXOSMITHKLINE-US2021AMR224139:Same reporter
Sex: U
Vaccine: VARZOS
Symptoms: Herpes zoster, Vaccination failure
Clinical narrative: shingles after the shot/Suspected vaccination failure; Shingles; This case was reported by a consumer viainteractive digital media and described the occurrence of suspected vaccination failure in an unspecified number of 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: The age at vaccination was not applicable for this case. The patients got shingles after they had the shingles vaccine. The doctor stated that many people do get. The follow up would not possible as contact information was not available. 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. This case had been linked with US2021AMR224136, reporter by same reporter.; Sender's Comments:  US-GLAXOSMITHKLINE-US2021AMR224136:Same reporter
Age: 85.0
Sex: M
Vaccine: DTAP
Symptoms: Product administered to patient of inappropriate age
Clinical narrative: infanrix/ Patient was 85.; This case was reported by a pharmacist via call center representative and described the occurrence of inappropriate age at vaccine administration in a 85-year-old male patient who received DTPa (Infanrix) for prophylaxis.   Co-suspect products included dtpa vaccine pre-filled syringe device (Infanrix Pre-Filled Syringe Device) injection syringe for prophylaxis.   The patient's past medical history included surgery (had stem cell surgery).   On an unknown date, the patient received Infanrix and Infanrix Pre-Filled Syringe Device. On an unknown date, unknown after receiving Infanrix and Infanrix Pre-Filled Syringe Device, the patient experienced inappropriate age at vaccine administration. On an unknown date, the outcome of the inappropriate age at vaccine administration 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 85 years old patient received Infanrix, which led to inappropriate age at vaccine administration. The reporter did not consent to follow up.
Age: 57.0
Sex: M
Vaccine: VARZOS
Symptoms: Blister, Fatigue, Migraine, Pain
Clinical narrative: Fatigue; Pain, Painful blister; Migraine; Painful blister around his left eye; This case was reported by a consumer via call center representative and described the occurrence of fatigue in a 57-year-old male patient who received Herpes zoster (Shingrix) for prophylaxis.   The patient's past medical history included shingles (had shingles before on left side of body).   On 18th October 2021, the patient received the 1st dose of Shingrix. On 19th October 2021, 1 days after receiving Shingrix, the patient experienced fatigue, pain, migraine and blister. In October 2021, the outcome of the fatigue, pain and migraine were recovered/resolved. On an unknown date, the outcome of the blister was not recovered/not resolved.   It was unknown if the reporter considered the fatigue, pain, migraine and blister to be related to Shingrix.  Additional details were provided as follows: The reporter was the patient. The reporter received the Shingris vaccine and in the following afternoon, he began to experience fatigue, pain, migraine and noticed a painful blister around his left eye.  The patient confirmed that the fatigue, pain and migraine had resolved since then in October 2021.  But the blister around his eye had not gone away and he was concerned because he had gotten shingles before and it was also on his left side of the body. The representative gave him medical advice disclaimer.  The patient was going to visit his health care professional (ophthalmologist) on the day of reporting to discuss as he was very concerned the event might affect his eyes.  The reporter consented to follow up and gave permission to contact health care professional.
Age: 54.0
Sex: M
Vaccine: VARZOS
Symptoms: Incorrect dose administered, Product preparation issue
Clinical narrative: Potentially received only the diluent portion; Potentially received only the diluent portion; This case was reported by a pharmacist via call center representative and described the occurrence of inappropriate preparation of medication in a 54-year-old male patient who received Herpes zoster (Shingrix) (batch number P2J7E, expiry date 10th October 2022) for prophylaxis.   On 16th August 2021, the patient received the 1st dose of Shingrix. On 16th August 2021, unknown after receiving Shingrix, 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 details were provided as follows: The patient received of only the diluent portion of Shingrix 1st dose, which led to inappropriate preparation of medication and inappropriate dose of vaccine administered. The pharmacist reported the potential of administering 3 doses of Shingrix dose due to the potential of the administration of only the diluent portion at month 0. The patient returned for 2nd dose on 21st October 2021, but it was suspected that the patient only received diluent portion on 16th August 2021. At the time of the reporting, it was unknown if 2nd dose of Shingrix vaccine was administered at time of call on 21st October 2021. The reporter consented to follow up.
Sex: M
Vaccine: VARZOS
Symptoms: Myalgia, Paranasal sinus discomfort, Pyrexia
Clinical narrative: Myalgia; Sinus pressure; low grade fever, 99.9 -100.4; This case was reported by a physician via call center representative and described the occurrence of myalgia in a male patient who received Herpes zoster (Shingrix) for prophylaxis.   Concomitant products included covid-19 vaccine (Covid 19 Vaccine).   In October 2021, the patient received the 1st dose of Shingrix. In October 2021, less than a week after receiving Shingrix, the patient experienced myalgia, sinus pressure and fever. On an unknown date, the outcome of the myalgia, sinus pressure and fever were not recovered/not resolved.   It was unknown if the reporter considered the myalgia, sinus pressure and fever to be related to Shingrix.   Additional details were reported as follows: This case was reported by the physician for himself. The age at vaccination was not reported. The physician stated that the patient received Shingrix vaccine and experienced myalgia, sinus pressure, low grade fever that ranged from 99.9 to 100.4 degree F for the past 3 days (exact date of onset not given). The physician reported he was currently taking cholesterol medication (medication name not given). The physician reported that he received the 3rd dose of the COIVD-19 Vaccine1 month ago (Manufacturer not provided). The physician wanted to know how long after receiving SHINGRIX do people experience side effects. The reporter did not consent to follow-up.
Sex: U
Vaccine: FLUX
Symptoms: Intensive care, Product administered to patient of inappropriate age
Clinical narrative: Patient was admitted to NICU, ICU for 24 hours observation; Flu vx adult given to baby; This case was reported by a other health professional via call center representative and described the occurrence of hospitalization in a infant patient who received Flu Seasonal QIV Dresden (Influenza vaccine Quadrivalent 2021-2022 season) for prophylaxis.   On 21st October 2021, the patient received Influenza vaccine Quadrivalent 2021-2022 season. On 21st October 2021, less than a day after receiving Influenza vaccine Quadrivalent 2021-2022 season, the patient experienced hospitalization (serious criteria hospitalization) and inappropriate age at vaccine administration. On an unknown date, the outcome of the hospitalization and inappropriate age at vaccine administration were unknown.   It was unknown if the reporter considered the hospitalization to be related to Influenza vaccine Quadrivalent 2021-2022 season.  Additional details were provided as follows: The age at vaccination was not reported. The patient received Flu vaccine for the adults which led to inappropriate age at vaccine administration. The reporter was not quite sure of how old the patient was.  The reporter was unsure if this was Fluarix or Flulaval vaccine as it was not specified on the afterhours VM box. The patient was admitted to newborn intensive care unit, intensive care unit for 24 hours observation.  The reporter consented to follow up. Adverse event was received on afterhours VM box, attempted several times to contact healthcare professional at the specific phone number provided on the VM for specific Flu vaccine and to clarify the age of the patient.  No additional details were available.