chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 78.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Endotracheal intubation, Gram stain negative, Influenza A virus test positive, Influenza B virus test positive, Intensive care
Clinical narrative: The patient reported to The Medical Center on 02/26/2022 with a worsening SOB.  The patient was recently admitted for COVID-PNA, and multiple PE's. In the ED the patient was on 4LNC, and chest x-ray showed multifocal PNA.  The patient was admitted and continued to have worsening oxygen requirements.  Pulmonology started the patient on dexamethasone.  The patient was intubated, and consulted with palliative care.  The patient was extubated on 03/08/2022 and made DNR/DNI status.  The patient expired on 03/11/2022.
Age: 78.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Mechanical ventilation, Pneumonia, Pulmonary embolism, Pyrexia, SARS-CoV-2 test positive
Clinical narrative: The patient reported to The Medical Center on 02/26/2022 with a worsening SOB.  The patient was recently admitted for COVID-PNA, and multiple PE's. In the ED the patient was on 4LNC, and chest x-ray showed multifocal PNA.  The patient was admitted and continued to have worsening oxygen requirements.  Pulmonology started the patient on dexamethasone.  The patient was intubated, and consulted with palliative care.  The patient was extubated on 03/08/2022 and made DNR/DNI status.  The patient expired on 03/11/2022.
Age: 78.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Speech disorder, Thrombocytopenia
Clinical narrative: The patient reported to The Medical Center on 02/26/2022 with a worsening SOB.  The patient was recently admitted for COVID-PNA, and multiple PE's. In the ED the patient was on 4LNC, and chest x-ray showed multifocal PNA.  The patient was admitted and continued to have worsening oxygen requirements.  Pulmonology started the patient on dexamethasone.  The patient was intubated, and consulted with palliative care.  The patient was extubated on 03/08/2022 and made DNR/DNI status.  The patient expired on 03/11/2022.
Age: 78.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: COVID-19 pneumonia, Chest X-ray abnormal, Death, Dyspnoea, Endotracheal intubation
Clinical narrative: The patient reported to The Medical Center on 02/26/2022 with a worsening SOB.  The patient was recently admitted for COVID-PNA, and multiple PE's. In the ED the patient was on 4LNC, and chest x-ray showed multifocal PNA.  The patient was admitted and continued to have worsening oxygen requirements.  Pulmonology started the patient on dexamethasone.  The patient was intubated, and consulted with palliative care.  The patient was extubated on 03/08/2022 and made DNR/DNI status.  The patient expired on 03/11/2022.
Age: 78.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Oxygen saturation decreased
Clinical narrative: The patient reported to The Medical Center on 02/26/2022 with a worsening SOB.  The patient was recently admitted for COVID-PNA, and multiple PE's. In the ED the patient was on 4LNC, and chest x-ray showed multifocal PNA.  The patient was admitted and continued to have worsening oxygen requirements.  Pulmonology started the patient on dexamethasone.  The patient was intubated, and consulted with palliative care.  The patient was extubated on 03/08/2022 and made DNR/DNI status.  The patient expired on 03/11/2022.
Age: 55.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Chills, Diarrhoea, Feeding disorder, Headache, Hot flush
Clinical narrative: When she got her vaccine, within a few hours she had a headache and felt sluggish. The pharmacy told her she may feel off a day or 2. She woke up the next day crying, freezing (wearing winter clothes) and hurting from head-to-toe. She stayed away from her husband to one end of the house. Even taking a shower hurt. She did not feel normal until last Friday. Nothing would stay down. She called her doctor and told her to keep pushing fluids. On Thursday she was able to hold down a muffin. She had dry heaves all night Tuesday night of last week. It hurt to take a bath. She called the pharmacy on Friday and was on the phone with them 30-40 minutes filing a report. She did not seek medical advice. Her doctor knew what was going on. The recommendation was still for her to continue what she was doing: push the fluids. She missed a week of work due to her symptoms. She is finally feeling normal. Still tired but doing better. She did not want to talk to anybody, just wanted to just sleep and felt her body was drained. She did not want to be touched and did not want to wear clothes. She tried to lie down in the bathtub but screamed it hurt so bad. She took Tylenol every few hours as instructed by her doctor, which did not phase her at all. On Thursday night, was feeling better and gradually increased her diet. She is still on a bland diet. She had diarrhea, vomiting and dry heaves. She had very minimal reactions to the other vaccines, slight headaches and fatigue, but nothing like this reaction. She took the vaccines but states she will not take another one due to her massive reaction.
Age: 55.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Hyperaesthesia, Myalgia, Nausea, Pain of skin, Vomiting
Clinical narrative: When she got her vaccine, within a few hours she had a headache and felt sluggish. The pharmacy told her she may feel off a day or 2. She woke up the next day crying, freezing (wearing winter clothes) and hurting from head-to-toe. She stayed away from her husband to one end of the house. Even taking a shower hurt. She did not feel normal until last Friday. Nothing would stay down. She called her doctor and told her to keep pushing fluids. On Thursday she was able to hold down a muffin. She had dry heaves all night Tuesday night of last week. It hurt to take a bath. She called the pharmacy on Friday and was on the phone with them 30-40 minutes filing a report. She did not seek medical advice. Her doctor knew what was going on. The recommendation was still for her to continue what she was doing: push the fluids. She missed a week of work due to her symptoms. She is finally feeling normal. Still tired but doing better. She did not want to talk to anybody, just wanted to just sleep and felt her body was drained. She did not want to be touched and did not want to wear clothes. She tried to lie down in the bathtub but screamed it hurt so bad. She took Tylenol every few hours as instructed by her doctor, which did not phase her at all. On Thursday night, was feeling better and gradually increased her diet. She is still on a bland diet. She had diarrhea, vomiting and dry heaves. She had very minimal reactions to the other vaccines, slight headaches and fatigue, but nothing like this reaction. She took the vaccines but states she will not take another one due to her massive reaction.
Age: 55.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Crying, Diarrhoea, Fatigue, Feeling abnormal, Feeling cold
Clinical narrative: When she got her vaccine, within a few hours she had a headache and felt sluggish. The pharmacy told her she may feel off a day or 2. She woke up the next day crying, freezing (wearing winter clothes) and hurting from head-to-toe. She stayed away from her husband to one end of the house. Even taking a shower hurt. She did not feel normal until last Friday. Nothing would stay down. She called her doctor and told her to keep pushing fluids. On Thursday she was able to hold down a muffin. She had dry heaves all night Tuesday night of last week. It hurt to take a bath. She called the pharmacy on Friday and was on the phone with them 30-40 minutes filing a report. She did not seek medical advice. Her doctor knew what was going on. The recommendation was still for her to continue what she was doing: push the fluids. She missed a week of work due to her symptoms. She is finally feeling normal. Still tired but doing better. She did not want to talk to anybody, just wanted to just sleep and felt her body was drained. She did not want to be touched and did not want to wear clothes. She tried to lie down in the bathtub but screamed it hurt so bad. She took Tylenol every few hours as instructed by her doctor, which did not phase her at all. On Thursday night, was feeling better and gradually increased her diet. She is still on a bland diet. She had diarrhea, vomiting and dry heaves. She had very minimal reactions to the other vaccines, slight headaches and fatigue, but nothing like this reaction. She took the vaccines but states she will not take another one due to her massive reaction.
Age: 55.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Headache, Hyperaesthesia, Impaired work ability, Pain, Retching
Clinical narrative: When she got her vaccine, within a few hours she had a headache and felt sluggish. The pharmacy told her she may feel off a day or 2. She woke up the next day crying, freezing (wearing winter clothes) and hurting from head-to-toe. She stayed away from her husband to one end of the house. Even taking a shower hurt. She did not feel normal until last Friday. Nothing would stay down. She called her doctor and told her to keep pushing fluids. On Thursday she was able to hold down a muffin. She had dry heaves all night Tuesday night of last week. It hurt to take a bath. She called the pharmacy on Friday and was on the phone with them 30-40 minutes filing a report. She did not seek medical advice. Her doctor knew what was going on. The recommendation was still for her to continue what she was doing: push the fluids. She missed a week of work due to her symptoms. She is finally feeling normal. Still tired but doing better. She did not want to talk to anybody, just wanted to just sleep and felt her body was drained. She did not want to be touched and did not want to wear clothes. She tried to lie down in the bathtub but screamed it hurt so bad. She took Tylenol every few hours as instructed by her doctor, which did not phase her at all. On Thursday night, was feeling better and gradually increased her diet. She is still on a bland diet. She had diarrhea, vomiting and dry heaves. She had very minimal reactions to the other vaccines, slight headaches and fatigue, but nothing like this reaction. She took the vaccines but states she will not take another one due to her massive reaction.
Age: 55.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Sluggishness, Vomiting
Clinical narrative: When she got her vaccine, within a few hours she had a headache and felt sluggish. The pharmacy told her she may feel off a day or 2. She woke up the next day crying, freezing (wearing winter clothes) and hurting from head-to-toe. She stayed away from her husband to one end of the house. Even taking a shower hurt. She did not feel normal until last Friday. Nothing would stay down. She called her doctor and told her to keep pushing fluids. On Thursday she was able to hold down a muffin. She had dry heaves all night Tuesday night of last week. It hurt to take a bath. She called the pharmacy on Friday and was on the phone with them 30-40 minutes filing a report. She did not seek medical advice. Her doctor knew what was going on. The recommendation was still for her to continue what she was doing: push the fluids. She missed a week of work due to her symptoms. She is finally feeling normal. Still tired but doing better. She did not want to talk to anybody, just wanted to just sleep and felt her body was drained. She did not want to be touched and did not want to wear clothes. She tried to lie down in the bathtub but screamed it hurt so bad. She took Tylenol every few hours as instructed by her doctor, which did not phase her at all. On Thursday night, was feeling better and gradually increased her diet. She is still on a bland diet. She had diarrhea, vomiting and dry heaves. She had very minimal reactions to the other vaccines, slight headaches and fatigue, but nothing like this reaction. She took the vaccines but states she will not take another one due to her massive reaction.
Age: 39.0
Sex: F
Vaccine: COVID19, FLU4, COVID19, COVID19, COVID19
Symptoms: Angiogram pulmonary abnormal, Anticoagulant therapy, Asthma, COVID-19, Complication of pregnancy
Clinical narrative: Pregnant patient up to date on COVID vaccines who admitted with COVID.  Provider d/c note: Patient is a 40 YO year old G9P3 (4 miscarriages), with a history patient report of cardiac problems during her last delivery, asthma, gestational diabetes, suicide attempt 23 weeks, depression with previous suicide attempt, asthma, anxiety, gestational diabetes, sleeve gastrectomy presenting to Hospital with complaint of coughing and shortness of breath. Labs show elevated ddimer, negative troponin, COVID + PCR. CTA shows ground glass opacity but not acute pulmonary embolism. She was given 1L LR, started on steroids. Started on remdesivir. Per pulmonology she is high risk. Due to her risk factors she will be transferred.
Age: 39.0
Sex: F
Vaccine: COVID19, FLU4, COVID19, COVID19, COVID19
Symptoms: Condition aggravated, Lung opacity, Maternal exposure before pregnancy, Ultrasound antenatal screen abnormal, Uterine leiomyoma
Clinical narrative: Pregnant patient up to date on COVID vaccines who admitted with COVID.  Provider d/c note: Patient is a 40 YO year old G9P3 (4 miscarriages), with a history patient report of cardiac problems during her last delivery, asthma, gestational diabetes, suicide attempt 23 weeks, depression with previous suicide attempt, asthma, anxiety, gestational diabetes, sleeve gastrectomy presenting to Hospital with complaint of coughing and shortness of breath. Labs show elevated ddimer, negative troponin, COVID + PCR. CTA shows ground glass opacity but not acute pulmonary embolism. She was given 1L LR, started on steroids. Started on remdesivir. Per pulmonology she is high risk. Due to her risk factors she will be transferred.
Age: 39.0
Sex: F
Vaccine: COVID19, FLU4, COVID19, COVID19, COVID19
Symptoms: Angiogram pulmonary abnormal, COVID-19, Cough, Dyspnoea, Fibrin D dimer increased
Clinical narrative: Pregnant patient up to date on COVID vaccines who admitted with COVID.  Provider d/c note: Patient is a 40 YO year old G9P3 (4 miscarriages), with a history patient report of cardiac problems during her last delivery, asthma, gestational diabetes, suicide attempt 23 weeks, depression with previous suicide attempt, asthma, anxiety, gestational diabetes, sleeve gastrectomy presenting to Hospital with complaint of coughing and shortness of breath. Labs show elevated ddimer, negative troponin, COVID + PCR. CTA shows ground glass opacity but not acute pulmonary embolism. She was given 1L LR, started on steroids. Started on remdesivir. Per pulmonology she is high risk. Due to her risk factors she will be transferred.
Age: 39.0
Sex: F
Vaccine: COVID19, FLU4, COVID19, COVID19, COVID19
Symptoms: Laboratory test, Lung opacity, Maternal exposure before pregnancy, SARS-CoV-2 test positive, Troponin normal
Clinical narrative: Pregnant patient up to date on COVID vaccines who admitted with COVID.  Provider d/c note: Patient is a 40 YO year old G9P3 (4 miscarriages), with a history patient report of cardiac problems during her last delivery, asthma, gestational diabetes, suicide attempt 23 weeks, depression with previous suicide attempt, asthma, anxiety, gestational diabetes, sleeve gastrectomy presenting to Hospital with complaint of coughing and shortness of breath. Labs show elevated ddimer, negative troponin, COVID + PCR. CTA shows ground glass opacity but not acute pulmonary embolism. She was given 1L LR, started on steroids. Started on remdesivir. Per pulmonology she is high risk. Due to her risk factors she will be transferred.
Age: 16.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Product administered to patient of inappropriate age
Clinical narrative: Patient underage.
Age: 16.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Unevaluable event
Clinical narrative: Patient underage.
Sex: U
Vaccine: VARZOS, VARZOS
Symptoms: Product preparation error
Clinical narrative: 8 patients got vx reconstituted w/wrong adjuvant; This case was reported by a other health professional via sales rep and described the occurrence of wrong solution used in drug reconstitution in a 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 wrong solution used in drug reconstitution. On an unknown date, the outcome of the wrong solution used in drug reconstitution was unknown.   Additional Information: GSK receipt date: 26-Aug-2022 Reporter's comment: The GlaxoSmithKline representative reported that a wrong solution used adverse event for Shingrix with limited information. The reporter reported that the office manager at one of his accounts stated that the Shingrix vaccine was reconstituted with the wrong adjuvant. He stated that instead of using the adjuvant that comes with Shingrix, an adjuvant specified for the Merck MMR vaccine was used to reconstitute the Shingrix antigen.   The reporter stated that office manager indicated that this event happened for 8 patients. The reporter had no further information regarding patient demographics or the vaccine itself. No follow-up was requested. The reporter did not consent to follow-up. Additional supportive information: The patient received Shingrix vaccine, which was reconstituted with wrong solution, which led to wrong solution used in drug reconstitution. This case was one of 8 cases, reported by same reporter.; Sender's Comments:  US-GSK-US2022AMR124633:Same reporter. US-GSK-US2022AMR124632:Same reporter. US-GSK-US2022AMR124631:Same reporter. US-GSK-US2022AMR124630:Same reporter. US-GSK-US2022AMR124629:Same reporter. US-GSK-US2022AMR124634:Same reporter. US-GSK-US2022AMR124628:Same reporter.
Age: 35.0
Sex: F
Vaccine: COVID19, COVID19, COVID19
Symptoms: Anaphylactic reaction, Blood test, Chest X-ray, Hepatic enzyme increased, Immunisation reaction
Clinical narrative: Severe anaphylaxis. Epinephrine injectiono, IV antihistamines, Fluid IVs, Steroids. Treatment received at Emergency Room.    Reaction lasted several hours.
Age: 4.0
Sex: M
Vaccine: COVID19
Symptoms: Chills, Decreased appetite, Diarrhoea, Exposure to SARS-CoV-2, Fatigue
Clinical narrative: I have already stated. Pt has had a fever for 8 days. Chills, body aches, loss of appetite, lethargy, diarrhea. However, I believe it has to do with the fact that he was given the immunization while he had symptoms of COVID and while his dad had COVID.
Age: 4.0
Sex: M
Vaccine: COVID19
Symptoms: Lethargy, Malaise, Pain, Pain in extremity, Pyrexia
Clinical narrative: I have already stated. Pt has had a fever for 8 days. Chills, body aches, loss of appetite, lethargy, diarrhea. However, I believe it has to do with the fact that he was given the immunization while he had symptoms of COVID and while his dad had COVID.
Age: 22.0
Sex: F
Vaccine: COVID19
Symptoms: Blood test, Chest pain, Dyspnoea, Stress echocardiogram, Syncope
Clinical narrative: Positional tachycardia, chest pain, shortness of breath, syncope
Age: 22.0
Sex: F
Vaccine: COVID19
Symptoms: Tachycardia, Ultrasound Doppler
Clinical narrative: Positional tachycardia, chest pain, shortness of breath, syncope
Age: 43.0
Sex: M
Vaccine: COVID19
Symptoms: Arthralgia, Fatigue, General physical health deterioration, Headache, Loss of consciousness
Clinical narrative: Severe and lasting body and muscle aches, headaches, fatigue, loss of consciousness, pain, muscle soreness and tightness, joint pain, and overall decline in health and mental and physical health and fitness
Age: 43.0
Sex: M
Vaccine: COVID19
Symptoms: Mental disorder, Muscle tightness, Myalgia, Pain
Clinical narrative: Severe and lasting body and muscle aches, headaches, fatigue, loss of consciousness, pain, muscle soreness and tightness, joint pain, and overall decline in health and mental and physical health and fitness
Sex: U
Vaccine: VARCEL
Symptoms: Product storage error
Clinical narrative: No adverse event; A HCP called and reported that doses of VARIVAX that were improperly stored were administered to four different patients with different dates of administration. No adverse effects reported. Additional AEs filed for the other three patients. No additi; This spontaneous report was received from a medical assistant, referring to a patient of unknown age and gender. The patient's pertinent medical history, concomitant medications, previous drug reactions, or allergies were not reported.  On 10-AUG-2022, the patient was vaccinated with improperly stored varicella virus vaccine live (oka/merck) (VARIVAX), at a dose of 0.5 milliliter (mL), once (strength, vaccination scheme, anatomical site of vaccination and route of administration were not reported; lot number reported as W003820, expiration date reported and validated as 02-FEB-2024) as prophylaxis, and a sterile diluent (product storage error). No adverse effects reported.  The vaccine experienced a temperature excursion of 6 degrees Fahrenheit (F) up to 14F for 14 hours and 10 minutes and 14F up to 46F (16.7F) for 5 hours and 40 minutes, for a total time frame of 19 hours and 50 minutes. There was no previous temperature excursion.; Sender's Comments:  US-009507513-2208USA006387:
Sex: U
Vaccine: MMRV
Symptoms: Product storage error
Clinical narrative: No additional AE; Nurse calling for TE evaluation on frozen products states one dose of PROQUAD was administered to one patient.; This spontaneous report was received from a licensed practical nurse and refers to a patient of unspecified age and gender. The patient's medical history and concurrent conditions were not reported. Concomitant medications included sterile diluent.   On 16-AUG-2022, the patient was vaccinated with an improperly stored dose of measles, mumps, rubella and varicella (oka-merck) virus vaccine live recombinant Human Albumin (rHA) (PROQUAD) lot #U026800, expiration date: 26-FEB-2023 (dose, anatomical location and route of administration were not provided) administered as prophylaxis (product storage error).  The improperly stored dose underwent a temperature excursion of 14 degrees Fahrenheit (F) up to 46 F (46.44 F) for 3 hours and 30 minutes without previous excursions. No adverse events were reported.
Sex: U
Vaccine: VARCEL
Symptoms: No adverse event, Product storage error
Clinical narrative: No additional adverse events; A medical assistant reported that an improperly stored VARIVAX vaccine was administered to a patient.; This spontaneous report was received from a medical assistant concerning 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 stored varicella virus vaccine live (oka/merck) (VARIVAX) subcutaneous injection, lot #T041505, expiration date: 09-DEC-2022, administered as prophylaxis for varicella infection, (strength, and route of administration were not provided) (Improper storage of product in use). The reporter stated that the vaccine was stored at a temperature of -14 Celsius degrees during 37 minutes, and that there were no previous temperature excursions. No additional adverse events were reported.
Sex: F
Vaccine: HEPA, VARCEL
Symptoms: Inappropriate schedule of product administration, No adverse event
Clinical narrative: No additional AE reported. No PQC reported. No further information was provided.; HCP reported that a patient received a dose of HAVRIX on 7/12/2022 and a dose of VARIVAX on 8/3/2022. Caller said the health department instructed the patient to repeat the dose of VARIVAX since HAVRIX and VARIVAX were given too close.; This spontaneous report has been received from a registered pharmacist concerning a 16-year-old female patient. Her concomitant medications, pertinent medical history, and drug reactions/allergies were not reported.  On 12-JUL-2022, the patient received a dose of hepatitis A vaccine inact (HAVRIX). On 03-AUG-2022, she received a dose of varicella virus vaccine live (Oka/Merck) (VARIVAX) subcutaneous injection (product quantity reported as 1) (inappropriate schedule of product administration). Both vaccines were administered for prophylaxis (strength, dose, route lot number, and expiration were not reported). The health department instructed the patient to repeat the dose of varicella virus vaccine live (Oka/Merck) (VARIVAX) since hepatitis A vaccine inact (HAVRIX) and varicella virus vaccine live (Oka/Merck) (VARIVAX) were given too close. This was filed as a precautionary adverse event (AE). No additional AE was reported, and no further information was provided.
Sex: U
Vaccine: VARCEL
Symptoms: Incorrect route of product administration, No adverse event
Clinical narrative: No additional AE reported; administered a dose of VARIVAX intramuscularly; This spontaneous report was received from a registered nurse referring to a patient of unspecified age and gender. Information regarding the patient's pertinent medical history, concurrent conditions, concomitant therapies and previous drug reactions or allergies was not provided.  On 22-AUG-2022, the patient was vaccinated with varicella virus vaccine live (Oka/Merck) (VARIVAX) (anatomical site of vaccination was not reported; lot number W003820 has been verified to be valid, expiration date reported and established as 02-FEB-2024) administered intramuscularly for prophylaxis (incorrect route of product administration).   No additional adverse event reported (no adverse event).
Sex: U
Vaccine: MMR
Symptoms: Accidental underdose
Clinical narrative: The child receiving the vaccine wiggled away and did not receive the full dose; This spontaneous report has been received from a nurse practitioner referring a patient of unknown age and gender. The patient's concurrent conditions, medical history and concomitant medications were not reported.   On an unknown date, the patient started therapy with measles, mumps, and rubella (wistar RA 27-3) virus vaccine, live (M-M-R II) subcutaneous injection, administered for prophylaxis (strength, dose, frequency, lot number, expiration date and route of administration were not provided).   On 22-AUG-2022 the patient did not receive the full dose (accidental underdose).   This is one of two cases from the same reporter.; Sender's Comments:  US-009507513-2208USA008733:
Sex: U
Vaccine: MMRV, VARCEL
Symptoms: Extra dose administered, Inappropriate schedule of product administration, No adverse event
Clinical narrative: no additional adverse event; Nurse reports patient was accidently administered both VARIVAX and PROQUAD on Aug 24, 2022. No further information provided. This agent therefore marked other fields as Not Applicable since no further information was provided at the time of the call.; was accidently administered both VARIVAX and PROQUAD; This spontaneous report was received from a nurse concerning a patient of unknown age and gender.  The patient's medical history, concurrent conditions and concomitant therapies were not reported.   On 24-AUG-2022, the patient was accidentally vaccinated with both varicella virus vaccine live (oka/merck) (VARIVAX) subcutaneous injection, lot #W003819, expiration date: 02-FEB-2024 (strength, and route of administration were not provided); and measles, mumps, rubella and varicella (oka-merck) virus vaccine live (recombinant Human albumin) (PROQUAD) subcutaneous injection, lot #W002784, expiration date: 24-JUL-2023 (strength, and route of administration were not provided), both administered for prophylaxis (inappropriate schedule of vaccine administered) (extra dose administered). No additional adverse events were reported.
Age: 66.0
Sex: F
Vaccine: HPV9
Symptoms: No adverse event, Product use issue
Clinical narrative: she did not have any symptoms or concerns; patient received her first dose of GARDASIL 9 at age 66; This spontaneous report was received from a female nurse practitioner reporting on herself.  The patient's medical history was not reported. The patient's concurrent conditions included  penicillin allergy (rash). Concomitant therapies were not reported.  On 26-AUG-2022, at age 66 (product use issue), the patient received her first dose of hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast) (GARDASIL 9) pre-filled syringe, lot #U008316, expiration date: 15-AUG-2023, administered intramuscularly, in the left arm, for prevention of HPV infection due to new sexual partners.  The patient stated that she was expecting to feel some discomfort or pain from the injection or in the next few days after the injection, but she did not. She stated that the lack of soreness in her arm made her wonder whether she actually got the correct vaccine. Otherwise, she didn't have any symptoms or concerns (no adverse event).  The patient did not seek medical attention. No lab diagnostic tests were performed.  Therapy with hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast) (GARDASIL 9) was not discontinued.
Sex: U
Vaccine: VARZOS, VARZOS
Symptoms: Feeling abnormal, Herpes zoster, Pain, Screaming, Vaccination failure
Clinical narrative: having an episode of shingles, for the 5th time! I've had all the shots too./Suspected vaccination failure; Shingles; Bad enough to scream through the 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 (Shingrix) for prophylaxis.   Co-suspect products included Herpes zoster (Shingrix) for prophylaxis.   On an unknown date, the patient received the 2nd dose of Shingrix and the 1st dose of Shingrix. On an unknown date, unknown after receiving Shingrix and Shingrix, the patient experienced vaccination failure (serious criteria GSK medically significant), shingles and pain. The patient was treated with medication unknown. 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 Shingrix and Shingrix.     Additional Information: GSK Receipt Date: 25-AUG-2022 Reporter's Comment: This case was reported by the patient via interactive digital media. The patient received both doses of Shingrix vaccine a long time ago from reporting. The patient was currently having an episode of shingles, for the 5th time. The patient stated after received all shots you could still get shingles, but it was a milder case, still miserable though. The patient was currently on medication for Shingles. The patient stated hate to think how bad it would be without the Shingrix vaccines. The patient stated that the breakthrough episodes were not bad but still bad enough to scream through the pain. The patient stated you could still get the shingles, but just a milder and shorter case of it. The doctor puts patient on medicine for each time. Additional supportive information: This case was considered as suspected vaccination failure as details regarding time to onset for shingles and laboratory confirmation regarding shingles were unknown at the time of reporting. Follow-up would not possible as no contact details were available.
Sex: M
Vaccine: COVID19, COVID19, VARZOS
Symptoms: Atrial fibrillation, Blood test, Diarrhoea, Injection site pain, Nausea
Clinical narrative: Atrial fibrillation; Vaccination site pain; Diarrhea; Nausea; Sores mouth; Weight loss; This case was reported by a consumer via other manufacturer and described the occurrence of atrial fibrillation in a elderly male patient who received Herpes zoster (Hz/su + AS01B) for prophylaxis.   Co-suspect products included ELASOMERAN (COVID-19 VACCINE MODERNA) for prophylaxis, TOZINAMERAN (PFIZER COVID-19 INJECTION) for prophylaxis and ibrutinib (Imbruvica) for chronic lymphoid leukemia.   Additional subject notes included Medical history- None.   On an unknown date, the patient received Hz/su + AS01B, COVID-19 VACCINE MODERNA (intramuscular) and PFIZER COVID-19 INJECTION (intramuscular). In April 2018, the patient started Imbruvica (oral) 420 mg once daily (420 mg daily). On an unknown date, unknown after receiving Hz/su + AS01B, the patient experienced atrial fibrillation (serious criteria GSK medically significant), injection site pain, diarrhea, nausea, sores mouth and weight loss. Imbruvica was continued with no change. On an unknown date, the outcome of the atrial fibrillation, diarrhea, nausea, sores mouth and weight loss were unknown and the outcome of the injection site pain was recovered/resolved.   The reporter considered the atrial fibrillation, injection site pain, diarrhea and nausea to be possibly related to Hz/su + AS01B. It was unknown if the reporter considered the sores mouth and weight loss to be related to Hz/su + AS01B.   Additional Information: GSK Receipt Date: 25-AUG-2022 Reporter's Comment: The patient had Moderna covid-19 vaccination and the shingles shot, one in each arm. There was no reported medical history. No known Allergies. No concomitant drugs taken. On an unknown date, the patient had Moderna covid-19 vaccination and the shingles shot, both were painful but resolved. It was unknown if patient was enrolled in a Covid-19 vaccine trial. an unknown date, unknown after receiving Covid-19 vaccine moderna, Pfizer covid-19 injection and Ibrutinib, the patient experienced atrial fibrillation (serious criteria GSK medically significant), diarrhea, nausea, sores mouth, weight loss and injection site pain. The primary reporter did not have the lot number information, because the packaging was discarded.  The reporter's causality for the event(s) of mouth sores and weight loss was not provided. The reporter considered the atrial fibrillation, diarrhea, nausea and injection site pain to be possibly related to Covid-19 vaccine moderna, Pfizer covid-19 injection and Ibrutinib. It was unknown if the reporter considered the sores mouth and weight loss to be related to Covid-19 vaccine moderna, Pfizer covid-19 injection and Ibrutinib.
Sex: M
Vaccine: COVID19, COVID19, VARZOS
Symptoms: Stomatitis, Weight, Weight decreased
Clinical narrative: Atrial fibrillation; Vaccination site pain; Diarrhea; Nausea; Sores mouth; Weight loss; This case was reported by a consumer via other manufacturer and described the occurrence of atrial fibrillation in a elderly male patient who received Herpes zoster (Hz/su + AS01B) for prophylaxis.   Co-suspect products included ELASOMERAN (COVID-19 VACCINE MODERNA) for prophylaxis, TOZINAMERAN (PFIZER COVID-19 INJECTION) for prophylaxis and ibrutinib (Imbruvica) for chronic lymphoid leukemia.   Additional subject notes included Medical history- None.   On an unknown date, the patient received Hz/su + AS01B, COVID-19 VACCINE MODERNA (intramuscular) and PFIZER COVID-19 INJECTION (intramuscular). In April 2018, the patient started Imbruvica (oral) 420 mg once daily (420 mg daily). On an unknown date, unknown after receiving Hz/su + AS01B, the patient experienced atrial fibrillation (serious criteria GSK medically significant), injection site pain, diarrhea, nausea, sores mouth and weight loss. Imbruvica was continued with no change. On an unknown date, the outcome of the atrial fibrillation, diarrhea, nausea, sores mouth and weight loss were unknown and the outcome of the injection site pain was recovered/resolved.   The reporter considered the atrial fibrillation, injection site pain, diarrhea and nausea to be possibly related to Hz/su + AS01B. It was unknown if the reporter considered the sores mouth and weight loss to be related to Hz/su + AS01B.   Additional Information: GSK Receipt Date: 25-AUG-2022 Reporter's Comment: The patient had Moderna covid-19 vaccination and the shingles shot, one in each arm. There was no reported medical history. No known Allergies. No concomitant drugs taken. On an unknown date, the patient had Moderna covid-19 vaccination and the shingles shot, both were painful but resolved. It was unknown if patient was enrolled in a Covid-19 vaccine trial. an unknown date, unknown after receiving Covid-19 vaccine moderna, Pfizer covid-19 injection and Ibrutinib, the patient experienced atrial fibrillation (serious criteria GSK medically significant), diarrhea, nausea, sores mouth, weight loss and injection site pain. The primary reporter did not have the lot number information, because the packaging was discarded.  The reporter's causality for the event(s) of mouth sores and weight loss was not provided. The reporter considered the atrial fibrillation, diarrhea, nausea and injection site pain to be possibly related to Covid-19 vaccine moderna, Pfizer covid-19 injection and Ibrutinib. It was unknown if the reporter considered the sores mouth and weight loss to be related to Covid-19 vaccine moderna, Pfizer covid-19 injection and Ibrutinib.
Sex: U
Vaccine: VARZOS
Symptoms: Herpes zoster, Post herpetic neuralgia, Pruritus, Stress, Vaccination failure
Clinical narrative: nerve pain; itch cones and goes; stressed; suspected vaccination failure/had shingles last October, had the shots in 2019; shingles/had shingles last October, had the shots in 2019; 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. In October 2021, more than a year after receiving Shingles vaccine, the patient experienced vaccination failure (serious criteria GSK medically significant) and shingles. On an unknown date, the patient experienced post herpetic neuralgia, pruritus and stress. On an unknown date, the outcome of the vaccination failure, shingles and stress were unknown and the outcome of the post herpetic neuralgia and pruritus were not recovered/not resolved.   It was unknown if the reporter considered the vaccination failure, shingles, post herpetic neuralgia, pruritus and stress to be related to Shingles vaccine.     Additional Information: GSK receipt date: 25-Aug-2022 Reporter's comment: The case was received from the patient via interactive digital media. The patient had shingles last October and he/she still have had the nerve pain and itch comes and gones. The patient called the pharmacy to get the shots and they said they could not give vaccine to him/her because he/she already had the shots in fall of 2019. The patient called his/her phyisican and he said that the patient had to wait 5 years. The patient was so stressed. The patient did not want to get shingles again. Additional supportive information: This case was considered as suspected vaccination failure since the details regarding the completion of primary vaccination schedule and laboratory confirmation of shingles were unknown at the time of reporting. The follow-up could not be possible as no contact details were available.
Sex: U
Vaccine: VARZOS, VARZOS
Symptoms: Eye pain, Eye pruritus, Headache, Ophthalmic herpes zoster, Vaccination failure
Clinical narrative: suspected vaccination failure; went into my eye; Still have to use drops in eye... three years later no pain or itch now/ Itch above eye; Still have to use drops in eye... three years later no pain or itch now; awful headache; 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.   Previously administered products included Shingles vaccine (the patient had early version of vaccine).   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), ophthalmic herpes zoster (serious criteria GSK medically significant), eye pruritus, eye pain and headache. The patient was treated with paracetamol (Tylenol) and ophthalmologicals (nos) (Eye Drops (Ingredients Unknown)). On an unknown date, the outcome of the vaccination failure, ophthalmic herpes zoster and headache were unknown and the outcome of the eye pruritus and eye pain were recovered/resolved.   It was unknown if the reporter considered the vaccination failure, ophthalmic herpes zoster, eye pruritus, eye pain and headache to be related to Shingles vaccine and Shingles vaccine.     Additional Information: GSK Receipt Date: 25-AUG-2022 Reporter's Comments: This case was received from consumer via  interactive digital media. The patient had an early version of vaccine.  The patient had an awful headache which was different from migraines or sinus. The patient had both shingles shot.  The patient had shingles into his/her eye. The patient was about 3 weeks of sunglasses even in the house. The patient had Itch above eye and used tylenol, eye drops and medication. The now had the two dose one. But the patient still using drops in eye twice a week. Three years later no pain or itch now. The follow-up could not be possible as no contact details were available. Additional supportive information: This case was considered as suspected vaccination failure since the details regarding time to onset and laboratory confirmation was shingles not provided. The case conservatively considered as suspected vaccination failure and two shingles vaccine coded as the suspect product.
Sex: F
Vaccine: VARZOS
Symptoms: Herpes zoster, Vaccination failure
Clinical narrative: suspected vaccination failure/had the shots and got it anyway; got it anyway; This case was reported by a consumer via interactive digital media and described the occurrence of vaccination failure in a female patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   The patient's past medical history included shingles (Family History) (patient's husband had worst shingles ).   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: 19-Aug-2022 Reporter's comment: The case was received from the patient via interactive digital media. The patient stated that this was a horrible illness. The patient had the shots and got them anyway. The physician said that how much worse that they would had been without the shots. The patient's husband had the worst. The patient had all new sympathy for her husband now. Additional supportive information: This case was considered as suspected vaccination failure since the details regarding the completion of primary vaccination schedule, time to onset and laboratory confirmation of shingles were unknown at the time of reporting. The follow-up could not be possible as no contact details were available.
Sex: U
Vaccine: VARZOS
Symptoms: Blindness, Herpes zoster, Hypoaesthesia, Ophthalmic herpes zoster, Pain
Clinical narrative: suspected vaccination failure/Got the shot. And still ended up getting it; getting it on eye; lost some sight in eye; getting it on left side of face, head; pain; some places no feeling; 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), ophthalmic herpes zoster (serious criteria GSK medically significant), loss of vision (serious criteria GSK medically significant), shingles, pain and hypoesthesia. On an unknown date, the outcome of the vaccination failure, ophthalmic herpes zoster, loss of vision, shingles and hypoesthesia were unknown and the outcome of the pain was not recovered/not resolved.   It was unknown if the reporter considered the vaccination failure, ophthalmic herpes zoster, loss of vision, shingles, pain and hypoesthesia to be related to Shingles vaccine.     Additional Information: GSK receipt date: 20-Aug-2022 Reporter's comment: The case was received from the patient via interactive digital media. The patient got the shot and still ended up getting them on left side of face, head and eye. The patient still have had pain, and some places no feeling and lost some sight in eye. Additional supportive information: This case was considered as suspected vaccination failure since the details regarding the completion of primary vaccination schedule, time to onset and laboratory confirmation of shingles were unknown at the time of reporting. The follow-up could not be possible as no contact details were available.
Sex: U
Vaccine: VARZOS
Symptoms: Vaccination failure
Clinical narrative: suspected vaccination failure/Got the shot. And still ended up getting it; getting it on eye; lost some sight in eye; getting it on left side of face, head; pain; some places no feeling; 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), ophthalmic herpes zoster (serious criteria GSK medically significant), loss of vision (serious criteria GSK medically significant), shingles, pain and hypoesthesia. On an unknown date, the outcome of the vaccination failure, ophthalmic herpes zoster, loss of vision, shingles and hypoesthesia were unknown and the outcome of the pain was not recovered/not resolved.   It was unknown if the reporter considered the vaccination failure, ophthalmic herpes zoster, loss of vision, shingles, pain and hypoesthesia to be related to Shingles vaccine.     Additional Information: GSK receipt date: 20-Aug-2022 Reporter's comment: The case was received from the patient via interactive digital media. The patient got the shot and still ended up getting them on left side of face, head and eye. The patient still have had pain, and some places no feeling and lost some sight in eye. Additional supportive information: This case was considered as suspected vaccination failure since the details regarding the completion of primary vaccination schedule, time to onset and laboratory confirmation of shingles were unknown at the time of reporting. The follow-up could not be possible as no contact details were available.
Sex: F
Vaccine: VARZOS, VARZOS
Symptoms: Herpes zoster, Vaccination failure
Clinical narrative: 2-shot vaccine and shingles/suspected vaccination failure; have Very bad shingles; This case was reported by a consumer via interactive digital media and described the occurrence of vaccination failure in a 56-year-old female patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   Co-suspect products included Herpes zoster (Shingles vaccine) for prophylaxis.   On an unknown date, the patient received the 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) 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 and Shingles vaccine.     Additional Information: GSK receipt date: 21-Aug-2022 Reporter's comment: The case was received from the consumer via interactive digital media. The patient (reporter's aunt) currently have had very bad shingles and both of them had the updated 2 shot vaccine. The reporter stated that but it was still a good idea to get the vaccine, as it apparently did work for most people, just not for everyone. The case was linked with case US2022AMR125486, reported by same reporter for different patient. Additional supportive information: This case was considered as suspected vaccination failure since the details regarding the time to onset and laboratory confirmation of shingles were unknown at the time of reporting. The follow-up could not be possible as no contact details were available.; Sender's Comments:  US-GSK-US2022AMR125486:Same reporter