chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 53.0
Sex: F
Vaccine: COVID19, COVID19, COVID19-2
Symptoms: Echocardiogram, Ejection fraction, Electrocardiogram, Fluid retention, Laboratory test
Clinical narrative: Shortness of breath, chest pain, dyspnea, Pulmonary HTN, Left Bundle Branch Block, Edema, Fluid Retention.
Age: 53.0
Sex: F
Vaccine: COVID19, COVID19, COVID19-2
Symptoms: Oedema, Pulmonary hypertension
Clinical narrative: Shortness of breath, chest pain, dyspnea, Pulmonary HTN, Left Bundle Branch Block, Edema, Fluid Retention.
Age: 0.58
Sex: M
Vaccine: COVID19
Symptoms: Expired product administered
Clinical narrative: Moderna COVID-19 Vaccine with lot number AS1417B was administered to a patient on March 9, 2023 at 11:30am, greater than 12 hours post first vial puncture on March 8, 2023 at 11:30am. Manager contacted Moderna Medical Support on 03/10/23 @ 8:02am, in which they sent the following statement: "Moderna has data to support the stability of its vaccine if appropriately stored according to the Storage and Handling section of the Fact Sheet for Healthcare Providers and Full Prescribing Information (1). If the dose was given within the 30-day beyond use date, was NOT exposed to ambient room temperature (46° to 77°F (8° to 25°C)) for greater than 24 hours and any previous temperature excursion was analyzed a
Age: 81.0
Sex: M
Vaccine: COVID19-2, FLU4
Symptoms: COVID-19, Chest X-ray normal, Malaise, Oropharyngeal pain, Pyrexia
Clinical narrative: Started having a fever and sore throat. Took a home COVID-19 test and was positive. Doctor prescribed PAXLOVID, took full course. Took another COVID-19 test and was negative. Felt fine for a week then started feeling symptoms again and tested positive for COVID-19. Had a chest X-ray and it was clear. Rested and tested negative a week later.
Age: 81.0
Sex: M
Vaccine: COVID19-2, FLU4
Symptoms: SARS-CoV-2 test positive
Clinical narrative: Started having a fever and sore throat. Took a home COVID-19 test and was positive. Doctor prescribed PAXLOVID, took full course. Took another COVID-19 test and was negative. Felt fine for a week then started feeling symptoms again and tested positive for COVID-19. Had a chest X-ray and it was clear. Rested and tested negative a week later.
Age: 68.0
Sex: F
Vaccine: COVID19
Symptoms: Arthralgia, Electronystagmogram, Gait disturbance, Limb discomfort, Muscle spasms
Clinical narrative: MY legs begin to get tight and painful  with constant cramping and joint pain. Therapy muscle rub, voltaren pain relief I had to began to use a cane for assist with walking.
Age: 68.0
Sex: F
Vaccine: COVID19
Symptoms: Pain in extremity, Ultrasound scan, Walking aid user, X-ray
Clinical narrative: MY legs begin to get tight and painful  with constant cramping and joint pain. Therapy muscle rub, voltaren pain relief I had to began to use a cane for assist with walking.
Age: 51.0
Sex: M
Vaccine: PNC20
Symptoms: Chest discomfort, Cough, Headache, Pyrexia, Rash
Clinical narrative: Patient experienced rash, bad headache, fever, cough, chest pressure and sensitivity to touch.
Age: 51.0
Sex: M
Vaccine: PNC20
Symptoms: Tenderness
Clinical narrative: Patient experienced rash, bad headache, fever, cough, chest pressure and sensitivity to touch.
Age: 2.0
Sex: F
Vaccine: DTAPHEPBIP, MMR, PNC13, VARCEL
Symptoms: Product storage error
Clinical narrative: Pediarix (DTaP-IPV-HepB) and Prevnar 13 vaccine trasported to clinic in portable cooler. A vaccine excursion occurred with the portable cooler. The temperature on the portable cooler went out of range based on GlaxoSmithkline and Pfizer/Wyeth manufacturer recommendations. The portable cooler reconditioned and Pediarix vaccine and Prevnar 13 admistered to patient. Manufacturer contacted by representative. Per the Health Department they were advised by GlaxoSmithKline and Pfizer/wyeth that the Pediaxrix and Prevnar 13 vaccine was not viable and the patient needed to be revaccinated.
Age: 35.0
Sex: F
Vaccine: COVID19
Symptoms: Blood test, Computerised tomogram, Dizziness, Dyspnoea, Electrocardiogram
Clinical narrative: Tachycardia, palpitations, lightheadedness, fatigue, pain at infection site, lethargy, shortness of breath
Age: 35.0
Sex: F
Vaccine: COVID19
Symptoms: Fatigue, Injection site pain, Lethargy, Palpitations, Tachycardia
Clinical narrative: Tachycardia, palpitations, lightheadedness, fatigue, pain at infection site, lethargy, shortness of breath
Age: 35.0
Sex: F
Vaccine: COVID19
Symptoms: Urine analysis
Clinical narrative: Tachycardia, palpitations, lightheadedness, fatigue, pain at infection site, lethargy, shortness of breath
Age: 56.0
Sex: F
Vaccine: VARZOS
Symptoms: Asthenia, Chills, Cough, Hypotension, Oropharyngeal pain
Clinical narrative: vomiting, weakness, coughing, fever, soe throat, chills, low blood pressure, pnemonia, sepsis
Age: 56.0
Sex: F
Vaccine: VARZOS
Symptoms: Pneumonia, Pyrexia, Sepsis, Vomiting
Clinical narrative: vomiting, weakness, coughing, fever, soe throat, chills, low blood pressure, pnemonia, sepsis
Age: 73.0
Sex: M
Vaccine: COVID19-2, FLU4, VARZOS
Symptoms: Blood test abnormal, COVID-19, Cardiac failure, Chest X-ray abnormal, Diuretic therapy
Clinical narrative: I went to the hospital, because I had shortness of breath the night before. When I got to the hospital, I was put on an IV and underwent bloodwork. A routine COVID-19 test was done, and the result was positive. I was then admitted on COVID-19 precautions. They gave me one dose of IV remdesivir and treated me for heart failure. I was also given a diuretic to get rid of the fluid buildup. I was discharged the next day. After that, everything was fine.
Age: 73.0
Sex: M
Vaccine: COVID19-2, FLU4, VARZOS
Symptoms: Dyspnoea, Fluid retention, SARS-CoV-2 test positive
Clinical narrative: I went to the hospital, because I had shortness of breath the night before. When I got to the hospital, I was put on an IV and underwent bloodwork. A routine COVID-19 test was done, and the result was positive. I was then admitted on COVID-19 precautions. They gave me one dose of IV remdesivir and treated me for heart failure. I was also given a diuretic to get rid of the fluid buildup. I was discharged the next day. After that, everything was fine.
Age: 35.0
Sex: F
Vaccine: HPV9, TDAP
Symptoms: Dry skin, Injection site rash, Lip pruritus, Lip swelling, Pruritus
Clinical narrative: On 3/1/2023 - Patient in to discuss a rash she had after receiving her immunizations on 2/15/2023. Later that day and the next day, she had a rash on her forearms and her legs, but very slight rash on her arms at the injection site. She also had her lips to swell with itching. She used some Benadryl for a few days with improvement. Last night she had itching on the soles of her feet and the palms of her hands. Today, the only visible rash is on her forearms and that looks dry and darker discolored, not a current looking inflammation process.
Age: 35.0
Sex: F
Vaccine: HPV9, TDAP
Symptoms: Rash, Skin discolouration
Clinical narrative: On 3/1/2023 - Patient in to discuss a rash she had after receiving her immunizations on 2/15/2023. Later that day and the next day, she had a rash on her forearms and her legs, but very slight rash on her arms at the injection site. She also had her lips to swell with itching. She used some Benadryl for a few days with improvement. Last night she had itching on the soles of her feet and the palms of her hands. Today, the only visible rash is on her forearms and that looks dry and darker discolored, not a current looking inflammation process.
Age: 62.0
Sex: F
Vaccine: COVID19
Symptoms: Bone scan normal, Breast cancer female, COVID-19, Chemotherapy, Computerised tomogram normal
Clinical narrative: It was a fever that got to be 102.0. I also had fatigue, but I did not know if that was from the chemo. I had cough and congestion as well as a fever. I completed a COVID-19 PCR test in the emergency room. I was given ringers lactate for hydration, and they decided that I could not get the PAXLOVID due to chemo. The hydration really helped and then it was just a matter of taking MOTRIN. I really noticed a difference after getting the IV. The fever broke and started going away. It took about 3 days to test negative. I still felt tired and fatigued but that may have been due to chemo. I went in for my annual mammogram in September of 2022 also following the 3rd dose of the COVID-19 vaccine. There was an abnormality seen so I had to go back in for an ultrasound. It showed cancer in breast and auxiliary lymph node on the left. I completed my chemo and will be going in for surgery at a later date.
Age: 62.0
Sex: F
Vaccine: COVID19
Symptoms: Cough, Echocardiogram normal, Fatigue, Lymphoma, Mammogram abnormal
Clinical narrative: It was a fever that got to be 102.0. I also had fatigue, but I did not know if that was from the chemo. I had cough and congestion as well as a fever. I completed a COVID-19 PCR test in the emergency room. I was given ringers lactate for hydration, and they decided that I could not get the PAXLOVID due to chemo. The hydration really helped and then it was just a matter of taking MOTRIN. I really noticed a difference after getting the IV. The fever broke and started going away. It took about 3 days to test negative. I still felt tired and fatigued but that may have been due to chemo. I went in for my annual mammogram in September of 2022 also following the 3rd dose of the COVID-19 vaccine. There was an abnormality seen so I had to go back in for an ultrasound. It showed cancer in breast and auxiliary lymph node on the left. I completed my chemo and will be going in for surgery at a later date.
Age: 62.0
Sex: F
Vaccine: COVID19
Symptoms: Pyrexia, Respiratory tract congestion, SARS-CoV-2 test positive, Ultrasound breast abnormal
Clinical narrative: It was a fever that got to be 102.0. I also had fatigue, but I did not know if that was from the chemo. I had cough and congestion as well as a fever. I completed a COVID-19 PCR test in the emergency room. I was given ringers lactate for hydration, and they decided that I could not get the PAXLOVID due to chemo. The hydration really helped and then it was just a matter of taking MOTRIN. I really noticed a difference after getting the IV. The fever broke and started going away. It took about 3 days to test negative. I still felt tired and fatigued but that may have been due to chemo. I went in for my annual mammogram in September of 2022 also following the 3rd dose of the COVID-19 vaccine. There was an abnormality seen so I had to go back in for an ultrasound. It showed cancer in breast and auxiliary lymph node on the left. I completed my chemo and will be going in for surgery at a later date.
Age: 56.0
Sex: M
Vaccine: HEPA
Symptoms: Expired product administered, No adverse event
Clinical narrative: Immunization given 3/8/23 but med expired 3/2/23. No adverse effects have been reported so far.
Age: 13.0
Sex: M
Vaccine: COVID19-2
Symptoms: Antibody test negative, Antinuclear antibody increased, Back pain, Bacterial test negative, Borrelia test negative
Clinical narrative: Patient admitted to hospital on 3/2/23 with moderate pericardial effusion after 2 months of gradual back pain, SOB, intermittent fevers. Exudative on pericardial fluid analysis. Peds Infectious Diseases consulted and believed postviral pericarditis or pericarditis secondary to mRNA vaccination.
Age: 13.0
Sex: M
Vaccine: COVID19-2
Symptoms: C-reactive protein increased, Dyspnoea, Epstein-Barr virus test negative, Pericardial effusion, Pericarditis
Clinical narrative: Patient admitted to hospital on 3/2/23 with moderate pericardial effusion after 2 months of gradual back pain, SOB, intermittent fevers. Exudative on pericardial fluid analysis. Peds Infectious Diseases consulted and believed postviral pericarditis or pericarditis secondary to mRNA vaccination.
Age: 13.0
Sex: M
Vaccine: COVID19-2
Symptoms: Pyrexia, Red blood cell sedimentation rate increased, Respiratory viral panel, Viral pericarditis, Viral test negative
Clinical narrative: Patient admitted to hospital on 3/2/23 with moderate pericardial effusion after 2 months of gradual back pain, SOB, intermittent fevers. Exudative on pericardial fluid analysis. Peds Infectious Diseases consulted and believed postviral pericarditis or pericarditis secondary to mRNA vaccination.
Age: 64.0
Sex: M
Vaccine: COVID19
Symptoms: Expired product administered
Clinical narrative: vaccine was out of date, expiration date was 2/12/23, dose was given 3/2/23
Age: 65.0
Sex: F
Vaccine: COVID19
Symptoms: Musculoskeletal discomfort
Clinical narrative: Pt describes some discomfort in the left shoulder. She states that she noticed this since  the vaccination. We offered to call her Dr. , however patient said that it is okay and that she will contact her Dr. instead.
Age: 68.0
Sex: M
Vaccine: COVID19
Symptoms: Expired product administered
Clinical narrative: vaccine was out of date, expiration date was 2/12/23, dose was given 3/2/23
Age: 61.0
Sex: M
Vaccine: COVID19
Symptoms: Expired product administered, No adverse event
Clinical narrative: vaccine expired on 2/12/23 and vaccine was given on 3/2/23, no adverse effects noted
Age: 48.0
Sex: F
Vaccine: COVID19-2
Symptoms: COVID-19, Computerised tomogram normal, Condition aggravated, Diplopia, Hyperhidrosis
Clinical narrative: I tested positive for COVID-19 on 02/24/2023 I was traveling back home from a trip. During the flight I started sweating and having double vision. I also had numbness on my left and fingers. I completed a course of PAXLOVID which caused me to have a Lupus flare up and hypertension of 150/100. Physician said that it was most likely a transsystemic episode during my flight. I continue to have numbness in my hand especially my fingers.
Age: 48.0
Sex: F
Vaccine: COVID19-2
Symptoms: Hypertension, Hypoaesthesia, SARS-CoV-2 test positive, Systemic lupus erythematosus, Ultrasound scan normal
Clinical narrative: I tested positive for COVID-19 on 02/24/2023 I was traveling back home from a trip. During the flight I started sweating and having double vision. I also had numbness on my left and fingers. I completed a course of PAXLOVID which caused me to have a Lupus flare up and hypertension of 150/100. Physician said that it was most likely a transsystemic episode during my flight. I continue to have numbness in my hand especially my fingers.
Sex: F
Vaccine: HPV9
Symptoms: No adverse event, Product administered to patient of inappropriate age
Clinical narrative: 55 Year Old Patient was administered Gardasil 9; No additional AE reported; This spontaneous report has been received from a nurse via a field employee referring to a 55-year-old female patient. The patient's pertinent medical history, drug reactions or allergies and concomitant medication were not provided.  On an unknown date, on referral from the patient's gynecologist, the patient was vaccinated with hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast) (GARDASIL 9) (strength, dose, route, lot number and expiration date were not provided) for prophylaxis at her primary care physician's office (product administered to patient of inappropriate age). No additional adverse event (AE) or product quality complaint (PQC) was reported. No further information was provided.
Sex: U
Vaccine: HPV9
Symptoms: Extra dose administered, No adverse event
Clinical narrative: no adverse event; HCP called to report that a patient was inadvertently given 4 doses of GARDASIL 9. She was given her first dose on 05/30/2019 at the age of 21 years old. The series was started over after not realizing the first dose was already given so the patient; This spontaneous report has been received from a physician concerning to a 25-years-old patient of unknown gender.  The patient's concurrent conditions, medical history and concomitant medications were not provided.  On 30-MAY-2019, the patient was vaccinated with the first dose of HPV rL1 6 11 16 18 31 33 45 52 58 VLP vaccine (yeast) (GARDASIL 9) (strength, dose, route of administration, anatomical location, lot# and expiration date were not provided). On 02-MAY-2022, the patient was vaccinated with the second dose of HPV rL1 6 11 16 18 31 33 45 52 58 VLP vaccine (yeast) (GARDASIL 9) (strength, dose, route of administration, anatomical location, lot# and expiration date were not provided) (it was thought that this was the first dose). On 30-SEP-2022, the patient was vaccinated with the third dose of HPV rL1 6 11 16 18 31 33 45 52 58 VLP vaccine (yeast) (GARDASIL 9) (strength, dose, route of administration, anatomical location, lot# and expiration date were not provided) and on 20-FEB-2023, the patient was inadvertently vaccinated with a fourth dose of HPV rL1 6 11 16 18 31 33 45 52 58 VLP vaccine (yeast) (GARDASIL 9) (strength, dose, route of administration, anatomical location, lot# and expiration date were not provided) (extra dose administered). No adverse event was reported. No further information was provided.
Sex: F
Vaccine: HPV9, HPV9
Symptoms: Inappropriate schedule of product administration, No adverse event
Clinical narrative: no additional AE's were reported; that the patient was given her second dose of GARDSIL 9 one month after her first dose instead of two months after the first dose; This spontaneous report was received from a medical assistant and refers to a female of unknown age.  The pertinent medical history, concomitant medications or drug reactions and allergies were not reported.  On an unknown date in January 2023, the patient was vaccinated with the first dose of hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast) (GARDASIL 9) (exact dose, injection site, route of administration, lot # and expiration date were not reported) for prophylaxis. On 25-FEB-2023, she was vaccinated with the second dose of hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast) (GARDASIL 9) prefilled syringe, injection, 0.5 milliliter, lot #U031056, expiration date 16-JUN-2024, administered intramuscularly (injection site was not provided)f or prophylaxis. The patient was given her second dose of hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast) (GARDASIL 9) one month after her first dose instead of two months after the first dose (inappropriate schedule of product administration). No additional adverse event was reported.
Age: 71.0
Sex: U
Vaccine: PPV
Symptoms: Expired product administered, No adverse event
Clinical narrative: no additional AEs,; RN calling to report that expired lot of PNEUMOVAX 23 was administered on 3/7/2023 and requests information for revaccination recommendations. No further information provided, no additional AEs, no PQCs. LOT U026796 EXP 1/28/2023; This spontaneous report as received from a registered nurse concerning a 71-year-old patient, gender unspecified. There was no information about the patient's medical history, concurrent conditions or concomitant medication.  On 07-MAR-2023 the patient was vaccinated with an expired dose of pneumococcal vaccine, polyvalent (23-valent)(PNEUMOVAX23), prefilled syringe, dose: 0.5 milliliter, frequency reported as once (0.5ml/once), lot # U026796, expiration date: 28-JAN-2023  for prophylaxis (Expired product administered)(route unspecified).    No further information provided, no additional adverse events, no PQCs.
Sex: M
Vaccine: BCG
Symptoms: Neoplasm malignant
Clinical narrative: Consumer stated he had taken BCG vaccine 5 years ago and had since developed cancer which he attributed to the vaccine.; This spontaneous report was received from a consumer and refers to a male patient of unknown age. There was no information about the patient's concurrent conditions, concomitant therapies or medical history provided.  On an unknown date in 2018 (reported as "5 years ago"), the patient started therapy with bcg live (BCG VACCINE ) (formulation defaulted as powder for injection, dose, anatomical location, lot # and expiration date were not reported) for tuberculosis bladder.  On an unknown date, the patient developed cancer which he attributed to the vaccine (neoplasm malignant). The outcome of neoplasm malignant was reported as not recovered/not resolved.  Causal relationship between neoplasm malignant and bcg live (BCG VACCINE ) was unknown.  Upon internal review, the event neoplasm malignant was determined to be medically significant.
Sex: U
Vaccine: VARZOS
Symptoms: Herpes zoster, Pain, Vaccination failure
Clinical narrative: Had shingrix in 2017, has shingles now/Suspected vaccination failure; Shingles; Painful; 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.   On an unknown date, the patient received Shingrix. In February 2023, more than 2 years after receiving Shingrix, the patient experienced vaccination failure (serious criteria GSK medically significant), shingles and pain. On an unknown date, the outcome of the vaccination failure was unknown and the outcome of the shingles and pain were not recovered/not resolved.   It was unknown if the reporter considered the vaccination failure, shingles and pain to be related to Shingrix.     Additional Information: GSK Receipt Date: 03-MAR-2023 Reporter's Comment: This case was reported by the patient via interactive digital media. The patient had Shingrix vaccine in 2017 and reported that he/she was in a shingles outbreak right now, second week and painful. The patient reported that not sure if Shingrix vaccine was helped at all. Additional Supportive Information: This case was considered as suspected vaccination failure as details regarding primary schedule, laboratory test confirming shingles were unknown at the time of reporting. Follow-up would not possible as no contact details were available.
Sex: U
Vaccine: VARZOS
Symptoms: Herpes zoster, Vaccination failure
Clinical narrative: had the shot but still got them/suspected vaccination failure; still got them; 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) 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: 03-MAR-2023  Reporter's comments: This case was reported by the patient via interactive digital media.  The reporter stated that the he/she got the shot and still had them (Shingles). Additional supportive information: This case was considered as suspected vaccination failure as details regarding completion of primary vaccination schedule, 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: U
Vaccine: VARZOS
Symptoms: Herpes zoster, Scar, Vaccination failure
Clinical narrative: had shingles shot, so my case was milder/suspected vaccination failure; shingles, milder case on head; marks on my forehead; This case was reported by a consumer via interactive digital media and described the occurrence of vaccination failure in a adult patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   The patient's past medical history included chickenpox (outbreak when the patient was 6 years old).   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 scar. On an unknown date, the outcome of the vaccination failure and shingles were unknown and the outcome of the scar was recovered/resolved.   It was unknown if the reporter considered the vaccination failure, shingles and scar to be related to Shingles vaccine.     Additional Information: GSK Receipt date: 03-Jan-2023 Reporter's Comment: This case was reported by the patient via interactive digital media. The patient stated that Shingles was worse in the early 60s than his/her initial Chickenpox outbreak. The patient stated that it took over a year for the marks on his/her forehead to finally fade away from the shingles outbreak. The patient stated that his/her case was milder, but funny they started on top of my head, just like when he/she had Chickenpox as a kid. 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. Follow-up would not possible as no contact details were available.
Sex: U
Vaccine: VARZOS, VARZOS
Symptoms: Herpes zoster, Vaccination failure
Clinical narrative: got both shots and still got it/Suspected Vaccination Failure; still got it; 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.   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 and shingles were unknown.   It was unknown if the reporter considered the vaccination failure and shingles to be related to Shingles vaccine and Shingles vaccine.   Additional Information: GSK Receipt Date: 28-FEB-2023 Reporter's Comment: This case was reported by a patient via interactive digital media. The reporter stated that you could still get shingles but not as bad. The patient got both shingles shots and still got shingles.  The reporter stated that doctor said it would have been worse if he/she did not get the shots. Additional Supportive Information: This case was considered as suspected vaccination failure as details regarding time to onset and laboratory test confirming shingles were unknown at the time of reporting. The follow up would not possible as no contact detail were available.
Sex: U
Vaccine: VARZOS
Symptoms: Herpes zoster, Vaccination failure
Clinical narrative: Suspected Vaccination Failure; My friend got after the vax; 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) 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: 28-FEB-2023 Reporter's Comment: This case was reported by the consumer via interactive digital media. The reporter reported that he/she was still mad because his/her friend got it after the vaccination. The reporter reported that crimes against humanity. Additional Supportive Information: This case was considered as suspected vaccination failure as details regarding primary schedule, laboratory test and time to onset confirming shingles were unknown at the time of reporting. Follow-up would not possible as no contact details were available.
Sex: U
Vaccine: VARZOS, VARZOS
Symptoms: Herpes zoster, Suicidal ideation, Vaccination failure
Clinical narrative: got the shots and got shingles/Suspected vaccination failure; bad shingles in groin area; This case was reported by a consumer via interactive digital media and described the occurrence of vaccination failure in a patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   Co-suspect products included Herpes zoster (Shingles vaccine) for prophylaxis.   The patient's past medical history included shingles (had shingles 5 years ago extremely bad whole way around waist not the whole way halfway).   On an unknown date, the patient received the 2nd dose of Shingles vaccine and the 1st dose of Shingles vaccine. On an unknown date, 6 months after receiving Shingles vaccine and 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 and Shingles vaccine.     Additional Information: GSK Receipt Date: 28-FEB-2023 Reporter's Comment: This case was reported by the patient via interactive digital media. The patient reported that two years after that he/she got the shot and got shingles 6 months later in groin area bad enough to commit suicide. The patient reported that got the Shingles shots afterwards two of them and guess what he/she got the shingles again just as bad. The patient reported that guess what it did not work. Additional Supportive Information: This case was considered as suspected vaccination failure as details regarding laboratory test and time to onset confirming shingles were unknown at the time of reporting. For verbatim bad enough to commit suicide not captured as event as it was expression reported by the patient. Follow-up would not possible as no contact details were available.
Sex: U
Vaccine: HEPA
Symptoms: Expired product administered, No adverse event
Clinical narrative: Expired Havrix administered; This case was reported by a nurse via other manufacturer and described the occurrence of expired vaccine used in a patient who received HAV (Havrix) (batch number unknown, expiry date 16th February 2023) for prophylaxis.   On 28th February 2023, the patient received Havrix. On 28th February 2023, unknown after receiving Havrix, the patient experienced expired vaccine used. On an unknown date, the outcome of the expired vaccine used was unknown.   Additional Information: GSK receipt date: 28-Feb-2023 Reporter comment: The nurse called to report that an expired dose of Havrix was given to a patient on the day of reporting.  The vaccine expired on16 February 2023. There was no additional adverse events and no product quality complaints. Additional Supportive Information: The patient was administered an expired dose of Havrix, which led to expired vaccine used.
Sex: U
Vaccine: FLU3
Symptoms: Product storage error
Clinical narrative: Improperly stored Flulaval administered; This case was reported by a nurse via other manufacturer and described the occurrence of incorrect storage of drug in an unspecified number of patients who received Flu Seasonal TIV Quebec (Flulaval) for prophylaxis.   Co-suspect products included flu seasonal tiv quebec ?????????? (????) (Flulaval Pre-Filled Syringe Device) injection syringe for prophylaxis.   On an unknown date, the patient received Flulaval and Flulaval Pre-Filled Syringe Device. On an unknown date, unknown after receiving Flulaval and Flulaval Pre-Filled Syringe Device, the patient experienced incorrect storage of drug. On an unknown date, the outcome of the incorrect storage of drug 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 Information: GSK Receipt Date: 28-Feb-2023 Reporter's Comments:  The reporter mentioned that separate patients administered either improperly stored, separate Flulaval separate Menactra or improperly stored and separate Trumenba on unknown date.  Improperly stored or separate Other Company Vaccine Detail Summary was located within following space. reporter was unable to further clarify these statements at current call time. No PQC reported. No further information provided. Additional Supportive Information: the patients received Flulaval vaccine, which was improperly stored, which led to incorrect storage of drug.
Sex: U
Vaccine: FLUX
Symptoms: Pain in extremity
Clinical narrative: Sore arm; This case was reported by a consumer via interactive digital media and described the occurrence of pain in arm in a patient who received Flu unspecified (Flu vaccine) for prophylaxis.   On an unknown date, the patient received Flu vaccine. On an unknown date, unknown after receiving Flu vaccine, 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 Flu vaccine.   Linked case(s) involving the same patient:US2023AMR034744   Additional Information: GSK Receipt Date: 01-MAR-2023 Reporter's comment: This case was reported by a patient via interactive digital media. The reporter stated that arm a little sore with flu shot. Additional Supportive Information: The follow up would not possible as no contact details were available. The case had been linked to US2023AMR034744, reported by the same reporter, for a different product.; Sender's Comments:  US-GSK-US2023AMR034744:Same reporter
Sex: U
Vaccine: VARZOS
Symptoms: Injected limb mobility decreased, Injection site mass, Pain in extremity
Clinical narrative: huge lump at the injection site; difficulty using my arm,; pain and difficulty using my arm; This case was reported by a consumer via interactive digital media and described the occurrence of injection site lump 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, 2 days after receiving Shingles vaccine, the patient experienced injection site lump, injected limb mobility decreased and pain in arm. On an unknown date, the outcome of the injection site lump, injected limb mobility decreased and pain in arm were unknown.   It was unknown if the reporter considered the injection site lump, injected limb mobility decreased and pain in arm to be related to Shingles vaccine.     Additional Information: GSK receipt date: 28-FEB-2023 Reporter's comment: This case was reported by a patient via interactive digital media. The patient received the shingles jab which had completely messed up the shoulder. The patient had huge lump at the injection site, pain and difficulty using arm, just 2 days after getting it 3 years ago. The patient researched the side effects after the ones he/she had from the first of 2.  The reporter reported that some people had been permanently disabled by the 2nd. The reporter reported that one was more than enough for me. Additional Supportive Information: The follow-up could not be possible as no contact details were available.
Sex: U
Vaccine: FLUX
Symptoms: Chills, Herpes zoster, Hyperhidrosis, Paraesthesia, Pruritus
Clinical narrative: shingles; chills; sweating; itching; tingling on right side of face; This case was reported by a consumer via interactive digital media and described the occurrence of shingles in a patient who received Flu unspecified (Flu vaccine) for prophylaxis.   On an unknown date, the patient received Flu vaccine. On an unknown date, unknown after receiving Flu vaccine, the patient experienced shingles, chills, sweating, pruritus and tingling. The patient was treated with vitamins nos (Vitamin). On an unknown date, the outcome of the shingles, chills, sweating, pruritus and tingling were unknown.   It was unknown if the reporter considered the shingles, chills, sweating, pruritus and tingling to be related to Flu vaccine.   Additional Information: GSK Receipt Date: 28-FEB-2023 Reporter's Comment: This case was reported by a patient via interactive digital media. The reporter stated that he/she did not get any shots anymore. The patient got the flu shot years ago and had the chills sweating and did not trust anyone. The patient went to the doctor one day, he/she had tingling on his/her right side of his/her face and itching and he/she went to the doctor and he said he thought that he/she had shingles, every so often he/she got that and it went away.  The patient took vitamins that his/her son put him/her on. Additional Supportive Information: The follow up would not possible as no contact detail were available. The event shingles was a possible diagnosis so it was captured conservatively and the outcome of tingling ,shingles and pruritus was kept unknown because it was stated that every so often he/she got that and it went away.
Sex: U
Vaccine: FLUX
Symptoms: Illness
Clinical narrative: made me sick; This case was reported by a consumer via interactive digital media and described the occurrence of sickness in a patient who received Flu unspecified (Flu vaccine) for prophylaxis.   The patient's past medical history included influenza and shingles.   On an unknown date, the patient received Flu vaccine. On an unknown date, unknown after receiving Flu vaccine, the patient experienced sickness. On an unknown date, the outcome of the sickness was unknown.   It was unknown if the reporter considered the sickness to be related to Flu vaccine.     Linked case(s) involving the same patient:  US2023AMR037453   Additional Information: GSK receipt date: 28-Feb-2023 Reporter's comment: This case was reported by a patient via interactive digital media. The patient stated that the flu shot had made him/her sick. Additional Supportive Information: This case had been linked with US2023AMR037453, same patient. The follow up would not possible as no contact details were available.; Sender's Comments:  US-GSK-US2023AMR037453:Same Patient
Sex: F
Vaccine: DTAPIPV
Symptoms: Inappropriate schedule of product administration, Product administered to patient of inappropriate age, Wrong product administered
Clinical narrative: Kinrix given to a 6 months-old; Received 3 doses of IPV; wrong vaccine administered; This case was reported by a other health professional via call center representative and described the occurrence of inappropriate age at vaccine administration in a 6-month-old female patient who received DTPa-IPV (Kinrix) (batch number H99J7, expiry date 26th May 2023) for prophylaxis.   Co-suspect products included dtpa-ipv vaccine pre-filled syringe device (Kinrix Pre-Filled Syringe Device) injection syringe for prophylaxis.   Previously administered products included Dtap vaccine (received 2 doses of Dtap vaccine) and IPV vaccine (received 3 doses of IPV vaccine).   On 28th February 2023, the patient received Kinrix and Kinrix Pre-Filled Syringe Device. On 28th February 2023, unknown after receiving Kinrix and Kinrix Pre-Filled Syringe Device, the patient experienced inappropriate age at vaccine administration, inappropriate schedule of vaccine administered and wrong vaccine administered. On an unknown date, the outcome of the inappropriate age at vaccine administration, inappropriate schedule of vaccine administered and wrong vaccine administered were unknown.     This report is made by GSK without prejudice and does not imply any admission or liability for the incident or its consequences.   Additional Information: GSK Receipt Date: 28-Feb-2023 Reporter's Comments:  Medical assistant reported on 28th February 2023, patient 6 month of age received by mistake Kinrix.  The patient received 2 previous Dtap doses and 3 doses of IPV. The reporter asked how to proceed. the reporter consented to follow up.  The Vaccine Administration Facility was the same as Primary Reporter. Additional Supportive Information: the patient received Kinrix by mistake at the age of 6 months of age, which led to inappropriate age at vaccine administration, inappropriate schedule of vaccine administered, and wrong vaccine administered.
Sex: U
Vaccine: MNQ
Symptoms: Incorrect dose administered, Product preparation issue
Clinical narrative: Reconstituted with incorrect diluent; Reconstituted with incorrect diluent, partial dose given; This case was reported by a other health professional via call center representative and described the occurrence of inappropriate preparation of medication in a patient who received Men ACWY-CRM NVS (Menveo) (batch number AMVA758A, expiry date 31st October 2024) for prophylaxis.   On an unknown date, the patient received Menveo. On an unknown date, unknown after receiving Menveo, the patient experienced inappropriate preparation of medication and inappropriate dose of vaccine administered. On an unknown date, the outcome of the inappropriate preparation of medication and inappropriate dose of vaccine administered were unknown.   Additional Information: GSK Receipt Date: 28-Feb-2023 Reporter's Comments:  A medical assistant reported that a patient received a partial dose of menveo, as one Men A (lyophilized component) vial was reconstituted with an incorrect diluent The reporter consented to follow up. Additional Supportive Information: the patient received Menveo as one men A vial, which was reconstituted with incorrect diluent, which led to inappropriate preparation of medication and inappropriate dose of vaccine administered.
Sex: U
Vaccine: RV1
Symptoms: Product preparation error
Clinical narrative: Vx given  using sterile water/ reconstituted using sterile water instead of the provided diluent; This case was reported by a nurse via call center representative and described the occurrence of wrong solution used in drug reconstitution in a 4-month-old patient who received Rota (Rotarix lyophilized formulation) for prophylaxis.   Co-suspect products included rotavirus vaccine oral applicator device (Rotarix Oral Applicator Device) oral applicator for prophylaxis.   On an unknown date, the patient received Rotarix lyophilized formulation and Rotarix Oral Applicator Device. On an unknown date, unknown after receiving Rotarix lyophilized formulation and Rotarix Oral Applicator Device, 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.     This report is made by GSK without prejudice and does not imply any admission or liability for the incident or its consequences.   Additional Information: GSK Receipt Date: 28-Feb-2023 Reporter's Comments: The health care professional did not had information regarding the vaccine lot number, patient's initials, gender, nor vaccination date.  For the date health care professional mentioned as past weeks. The vaccine administration facility was the same as primary reporter.  The reporter consented to follow up. Additional Supportive Information: The patient was administered a dose of Rotarix but dose was reconstituted using sterile water instead of the provided diluent, which led to wrong solution used in drug reconstitution. This case had been linked with US2023032797, reported by the same reporter.; Sender's Comments:  US-GSK-US2023032797:Same reporter
Sex: U
Vaccine: RV1
Symptoms: Product preparation error
Clinical narrative: Vx given  using sterile water/reconstituted using sterile water; This case was reported by a nurse via call center representative and described the occurrence of wrong solution used in drug reconstitution in a 2-month-old patient who received Rota (Rotarix lyophilized formulation) for prophylaxis.   Co-suspect products included rotavirus vaccine oral applicator device (Rotarix Oral Applicator Device) oral applicator for prophylaxis.   On an unknown date, the patient received Rotarix lyophilized formulation and Rotarix Oral Applicator Device. On an unknown date, unknown after receiving Rotarix lyophilized formulation and Rotarix Oral Applicator Device, 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.     This report is made by GSK without prejudice and does not imply any admission or liability for the incident or its consequences.   Additional Information: GSK Receipt Date: 28-Feb-2023 Reporter's Comments: The health care professional did not had information regarding the vaccine lot number, patient's initials, gender, nor vaccination date.  For the date health care professional mentioned as past weeks. The vaccine administration facility was the same as primary reporter.  The reporter consented to follow up. Additional Supportive Information: The patient was administered a dose of Rotarix but dose was reconstituted using sterile water instead of the provided diluent, which led to wrong solution used in drug reconstitution. This case had been linked with US2023032793, reported by the same reporter.; Sender's Comments:  US-GSK-US2023032793:Same reporter
Age: 1.0
Sex: F
Vaccine: HEPA
Symptoms: Expired product administered
Clinical narrative: Expired Havrix administered; This case was reported by a nurse via call center representative and described the occurrence of expired vaccine used in a 20-month-old female patient who received HAV (Havrix) (batch number EP47E, expiry date 6th February 2023) for prophylaxis.   On 27th February 2023, the patient received Havrix. On 27th February 2023, unknown after receiving Havrix, the patient experienced expired vaccine used. On an unknown date, the outcome of the expired vaccine used was unknown.   Additional Information: GSK Receipt Date: 28-Feb-2023 Reporter's Comments:  Nurse Practitioner (NP) reports administration of Havrix following after expiration date. The reporter consented to follow up. Additional Supportive Information: The patient received Havrix after expiration date, which led to expired vaccine used.
Age: 2.0
Sex: F
Vaccine: HEPA
Symptoms: Expired product administered, No adverse event
Clinical narrative: Expired Havrix was administered; This case was reported by a other health professional via call center representative and described the occurrence of expired vaccine used in a 2-year-old female patient who received HAV (Havrix) (batch number LY35X, expiry date 16th February 2023) for prophylaxis.   Co-suspect products included hepatitis A vaccine pre-filled syringe device (Havrix Pre-Filled Syringe Device) injection syringe for prophylaxis.   On 28th February 2023, the patient received Havrix and Havrix Pre-Filled Syringe Device. On 28th February 2023, unknown after receiving Havrix and Havrix Pre-Filled Syringe Device, the patient experienced expired vaccine used. On an unknown date, the outcome of the expired vaccine used was unknown.   This report is made by GSK without prejudice and does not imply any admission or liability for the incident or its consequences.   Additional Information: GSK receipt date: 28-Feb-2023 Reporter comment: The healthcare professional reported that the patient received an expired dose of Havrix.  There were no reactions reported.  The reporter consented to follow up via email or postal. Additional Supportive Information: The patient was administered an expired dose of Havrix, which led to expired vaccine used.
Age: 16.0
Sex: F
Vaccine: MENB
Symptoms: Expired product administered
Clinical narrative: expired dose administered; This case was reported by a other health professional via call center representative and described the occurrence of expired vaccine used in a 16-year-old female patient who received Men B NVS (Bexsero) (batch number A2X3Y, expiry date 28th February 2023) for prophylaxis.   Co-suspect products included meningococcal B recom vaccine + aloh + omv pre-filled syringe device (Bexsero Pre-Filled Syringe Device) injection syringe for prophylaxis.   On 1st March 2023, the patient received Bexsero and Bexsero Pre-Filled Syringe Device. On 1st March 2023, unknown after receiving Bexsero and Bexsero Pre-Filled Syringe Device, the patient experienced expired vaccine used. On an unknown date, the outcome of the expired vaccine used was unknown.   This report is made by GSK without prejudice and does not imply any admission or liability for the incident or its consequences.   Additional Information: GSK Receipt Date: 01-MAR-2023 Reporter's comments: A medical assistant reported that, an expired dose of Bexsero vaccine was administered on 1st March 2023 which was expired on 28th February 2023. The reporter had consented to follow-up. Additional supportive information: The patient had received Bexsero vaccine which was already expired in 28th February 2023, which had led to expired vaccine used.