chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 12.0
Sex: M
Vaccine: COVID19, COVID19, COVID19, COVID19
Symptoms: Chest pain, Dysstasia, Gait inability, Headache, Impaired healing
Clinical narrative: This is regarding my son who is 12 years old. After he received a Pfizer booster vaccine, he had a high fever and involuntary leg movement that night. The next day he had experienced Vertigo symptoms (room spinning) and nausea. It was to the point that he couldn't even stand. It has been a week since he experienced this and things are not getting any better. We have seen the ENT doctor today 1/25th and he prescribed steroids and is suspecting inflammation on his inner ear for balancing nerves.
Age: 12.0
Sex: M
Vaccine: COVID19, COVID19, COVID19, COVID19
Symptoms: Magnetic resonance imaging head normal, Neurological examination normal, Vertigo, Vestibular neuronitis
Clinical narrative: This is regarding my son who is 12 years old. After he received a Pfizer booster vaccine, he had a high fever and involuntary leg movement that night. The next day he had experienced Vertigo symptoms (room spinning) and nausea. It was to the point that he couldn't even stand. It has been a week since he experienced this and things are not getting any better. We have seen the ENT doctor today 1/25th and he prescribed steroids and is suspecting inflammation on his inner ear for balancing nerves.
Age: 12.0
Sex: M
Vaccine: COVID19, COVID19, COVID19, COVID19
Symptoms: Chills, Pyrexia, Tremor, Vertigo, Vestibular neuronitis
Clinical narrative: This is regarding my son who is 12 years old. After he received a Pfizer booster vaccine, he had a high fever and involuntary leg movement that night. The next day he had experienced Vertigo symptoms (room spinning) and nausea. It was to the point that he couldn't even stand. It has been a week since he experienced this and things are not getting any better. We have seen the ENT doctor today 1/25th and he prescribed steroids and is suspecting inflammation on his inner ear for balancing nerves.
Age: 12.0
Sex: M
Vaccine: COVID19, COVID19, COVID19, COVID19
Symptoms: Dyskinesia, Dysstasia, Inner ear inflammation, Nausea, Pyrexia
Clinical narrative: This is regarding my son who is 12 years old. After he received a Pfizer booster vaccine, he had a high fever and involuntary leg movement that night. The next day he had experienced Vertigo symptoms (room spinning) and nausea. It was to the point that he couldn't even stand. It has been a week since he experienced this and things are not getting any better. We have seen the ENT doctor today 1/25th and he prescribed steroids and is suspecting inflammation on his inner ear for balancing nerves.
Age: 12.0
Sex: M
Vaccine: COVID19, COVID19, COVID19, COVID19
Symptoms: Vertigo
Clinical narrative: This is regarding my son who is 12 years old. After he received a Pfizer booster vaccine, he had a high fever and involuntary leg movement that night. The next day he had experienced Vertigo symptoms (room spinning) and nausea. It was to the point that he couldn't even stand. It has been a week since he experienced this and things are not getting any better. We have seen the ENT doctor today 1/25th and he prescribed steroids and is suspecting inflammation on his inner ear for balancing nerves.
Age: 28.0
Sex: F
Vaccine: COVID19
Symptoms: Paraesthesia
Clinical narrative: Appx 20-30 min after injection, I started to have tingling of the right side of my face starting with my eyebrow, then moving to my cheek and then my chin. Sensations to sharp and dull were not altered. Tingling remains
Age: 63.0
Sex: F
Vaccine: COVID19, VARZOS
Symptoms: Arthralgia, Joint range of motion decreased
Clinical narrative: Extreme and intense shoulder pain. Limited range of motion
Age: 27.0
Sex: F
Vaccine: COVID19
Symptoms: Disturbance in attention, Facial discomfort, Head discomfort, Hypoaesthesia
Clinical narrative: 12 hours after getting 1st dose pt feeling numbness sensation and feels like their is air in forehead, which goes down to cheeks and causes her to lose focus. pt will f/u with md
Age: 7.0
Sex: F
Vaccine: COVID19
Symptoms: Incorrect dose administered, Product preparation error
Clinical narrative: Pfizer Orange cap 5-11 covid19 vaccine wasn't diluted with 1.3.ml of saline and 0.2ml dose was administered from the original stock vial.
Age: 32.0
Sex: F
Vaccine: COVID19
Symptoms: Mechanical urticaria, Pruritus, Urticaria
Clinical narrative: Broke out in hives on my legs and neck in the middle of the night. Began taking Benadryl every four hours and using calamine lotion on itchy areas, which would consistently change location every couple of hours. Hives went away after a couple days but the itchiness remained, particularly around my ankles and wrists. Developed dermatographia. Switched to taking Zyrtec once a day which hinders the itchiness, but the dermatographia remains and the itchiness returns in full force all over my body after 24 hours. It?s now been a month and the symptoms haven?t lessened anymore.
Age: 59.0
Sex: M
Vaccine: COVID19
Symptoms: Feeling hot, Paraesthesia, Pruritus, Urticaria
Clinical narrative: Itching tingling all over my body Icy hot feeling or sunburn type feeling all over- pins and Needles type feelings hands arms legs ears forehead head and then hives broke out behind my ear and one on my forehead
Age: 57.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Acute kidney injury, Dialysis, Fatigue, Renal failure
Clinical narrative: A few days after the 2nd shot, fatique set in and continued getting worse as time went on. Finally went to my PCP and he ran tests and I was in kidney failure. This was June 3, 2021. Was on emergency dialysis within 12 hours. I had an AKI. I have neer had any kidney issues ever in my life.
Age: 68.0
Sex: F
Vaccine: COVID19
Symptoms: Inflammation
Clinical narrative: PATIENT REPORTED SHOULDER INFLAMMATION OR POSSIBLE SIRVA
Age: 21.0
Sex: F
Vaccine: COVID19
Symptoms: Arthralgia, Blood test, Gait disturbance, Headache, Loss of personal independence in daily activities
Clinical narrative: Within a few hours of receiving the vaccine, I started having muscle pain. This pain was unlike the aches I had previously had with previous doses of the Moderna Covid vaccine (with the second vaccine, I experienced achy muscles and a bad headache for 10 days. The headache never fully went away). This time it included sharp shooting pains in my neck, hands, forearms, torso, thigh, feet, hips, ankles, elbows and  knees. The pain is severe enough that it is difficult to walk or do daily tasks. Initially, I took Advil to try to address the pain, but it did very little. I went to my primary care doctor on January 20th who diagnosed me with muscle inflammation and gave me a steroid injection in my buttocks, as well as Toradol to try to relieve the pain. The Toradol did not help at all. It has been over five days since the steroid injection, but if there has been any improvement in the pain, it is very slight. I still have a lot of pain whether I am laying still or moving. I was required to receive the booster to return to college, or submit to weekly testing.
Age: 21.0
Sex: F
Vaccine: COVID19
Symptoms: Muscle enzyme, Myalgia, Myositis, Neck pain, Pain
Clinical narrative: Within a few hours of receiving the vaccine, I started having muscle pain. This pain was unlike the aches I had previously had with previous doses of the Moderna Covid vaccine (with the second vaccine, I experienced achy muscles and a bad headache for 10 days. The headache never fully went away). This time it included sharp shooting pains in my neck, hands, forearms, torso, thigh, feet, hips, ankles, elbows and  knees. The pain is severe enough that it is difficult to walk or do daily tasks. Initially, I took Advil to try to address the pain, but it did very little. I went to my primary care doctor on January 20th who diagnosed me with muscle inflammation and gave me a steroid injection in my buttocks, as well as Toradol to try to relieve the pain. The Toradol did not help at all. It has been over five days since the steroid injection, but if there has been any improvement in the pain, it is very slight. I still have a lot of pain whether I am laying still or moving. I was required to receive the booster to return to college, or submit to weekly testing.
Age: 21.0
Sex: F
Vaccine: COVID19
Symptoms: Pain in extremity
Clinical narrative: Within a few hours of receiving the vaccine, I started having muscle pain. This pain was unlike the aches I had previously had with previous doses of the Moderna Covid vaccine (with the second vaccine, I experienced achy muscles and a bad headache for 10 days. The headache never fully went away). This time it included sharp shooting pains in my neck, hands, forearms, torso, thigh, feet, hips, ankles, elbows and  knees. The pain is severe enough that it is difficult to walk or do daily tasks. Initially, I took Advil to try to address the pain, but it did very little. I went to my primary care doctor on January 20th who diagnosed me with muscle inflammation and gave me a steroid injection in my buttocks, as well as Toradol to try to relieve the pain. The Toradol did not help at all. It has been over five days since the steroid injection, but if there has been any improvement in the pain, it is very slight. I still have a lot of pain whether I am laying still or moving. I was required to receive the booster to return to college, or submit to weekly testing.
Age: 27.0
Sex: F
Vaccine: COVID19
Symptoms: Angioedema, Antinuclear antibody negative, Mechanical urticaria, Urticaria
Clinical narrative: spontaneous urticaria all over body, angioedema of the face, eyelids, lips. dermatographia. symptoms began 10 days after Moderna booster (1/11/22).   Began PO prednisone 60mg x 7 days, 40mg x 7 days, 20 mg x 7 days. currently tapering.
Age: 19.0
Sex: F
Vaccine: COVID19
Symptoms: Arthralgia, Joint range of motion decreased, Myalgia
Clinical narrative: Little to no shoulder range of motion, neck pain, shoulder muscle pain, injection site was almost to corner of shoulder (too high)
Age: 51.0
Sex: F
Vaccine: COVID19
Symptoms: Chest pain, Electrocardiogram, Hyperglycaemia, Palpitations, Troponin
Clinical narrative: palpitations, chest pain
Age: 29.0
Sex: M
Vaccine: COVID19
Symptoms: Pruritus, Skin swelling
Clinical narrative: Itchiness, puffiness... See previous notes given.
Age: 41.0
Sex: M
Vaccine: COVID19
Symptoms: Incorrect dose administered, Product storage error, Syringe issue, Underdose
Clinical narrative: The vaccine had been placed on an administration tray in a cooler and had an ice pack underneath the tray. The vaccine froze and was attempted to be administered before this was realized.  During administration, it was noticed the syringe would not completely empty the contents, so only about 0.15 mL was administered.
Age: 24.0
Sex: F
Vaccine: COVID19
Symptoms: Abdominal pain upper, Arthralgia, Chest pain, Discomfort, Fatigue
Clinical narrative: Fatigue  Soreness and joint pain Nausea  Stomach pain  Chest pain and elevated heart rate  Sensitive skin - hypersensitive to touch Headache  Fever Injection site/ arm soreness and limited mobility
Age: 24.0
Sex: F
Vaccine: COVID19
Symptoms: Headache, Heart rate increased, Injection site pain, Mobility decreased, Nausea
Clinical narrative: Fatigue  Soreness and joint pain Nausea  Stomach pain  Chest pain and elevated heart rate  Sensitive skin - hypersensitive to touch Headache  Fever Injection site/ arm soreness and limited mobility
Age: 24.0
Sex: F
Vaccine: COVID19
Symptoms: Pain of skin, Pyrexia, Sensitive skin
Clinical narrative: Fatigue  Soreness and joint pain Nausea  Stomach pain  Chest pain and elevated heart rate  Sensitive skin - hypersensitive to touch Headache  Fever Injection site/ arm soreness and limited mobility
Age: 41.0
Sex: F
Vaccine: COVID19
Symptoms: Parosmia
Clinical narrative: Phantosmia- I have been smelling cigarette like smells when they aren?t present without having had a Covid infection.
Age: 59.0
Sex: M
Vaccine: COVID19
Symptoms: Anxiety, Asthenia, Dizziness, Fall, Fear of injection
Clinical narrative: Systemic: Dizziness / Lightheadness-Mild, Systemic: Fainting / Unresponsive-Mild, Systemic: Shakiness-Mild, Systemic: Weakness-Mild, Additional Details: UPON ARRIVAL, PATIENT REPORTED FEAR OF NEEDLES AND ANXIETY REGARDING UPCOMING APPOINTMENT. AFTER VACCINATION, PATIENT SAT IN WAITING AREA FOR OBSERVATION FOR APPROXIMATELY 10-15 MINUTES. UPON EXITING, PATIENT EXPERIENCED A FALL INSIDE THE STORE. PATIENT DENIES HITTING THEIR HEAD DURING THE FALL. PATIENT WAS EVALUATED BY EMS WITH SUBSEQUENT NORMAL VITAL SIGNS. PATIENT REFUSED ADDITIONAL CARE BY EMS. THEY WERE OBSERVED FOR ANOTHER 10-15 MINUTES UNTIL THEIR SISTER ARRIVED TO TRANSPORT THEM HOME.
Age: 59.0
Sex: M
Vaccine: COVID19
Symptoms: Syncope, Tremor, Unresponsive to stimuli
Clinical narrative: Systemic: Dizziness / Lightheadness-Mild, Systemic: Fainting / Unresponsive-Mild, Systemic: Shakiness-Mild, Systemic: Weakness-Mild, Additional Details: UPON ARRIVAL, PATIENT REPORTED FEAR OF NEEDLES AND ANXIETY REGARDING UPCOMING APPOINTMENT. AFTER VACCINATION, PATIENT SAT IN WAITING AREA FOR OBSERVATION FOR APPROXIMATELY 10-15 MINUTES. UPON EXITING, PATIENT EXPERIENCED A FALL INSIDE THE STORE. PATIENT DENIES HITTING THEIR HEAD DURING THE FALL. PATIENT WAS EVALUATED BY EMS WITH SUBSEQUENT NORMAL VITAL SIGNS. PATIENT REFUSED ADDITIONAL CARE BY EMS. THEY WERE OBSERVED FOR ANOTHER 10-15 MINUTES UNTIL THEIR SISTER ARRIVED TO TRANSPORT THEM HOME.
Age: 56.0
Sex: F
Vaccine: COVID19
Symptoms: Rash
Clinical narrative: Systemic: Allergic: Rash Generalized-Mild
Age: 18.0
Sex: F
Vaccine: COVID19
Symptoms: Abdominal pain, Confusional state, Dyspnoea, Flushing, Hyperhidrosis
Clinical narrative: Systemic: Allergic: Difficulty Breathing-Medium, Systemic: Abdominal Pain-Medium, Systemic: Confusion-Medium, Systemic: Fainting / Unresponsive-Medium, Systemic: Flushed / Sweating-Medium, Systemic: Seizure-Medium, Systemic: Shakiness-Medium, Additional Details: patient developed symptoms about 5 minutes after receiving vaccine.  She started looking very pale and looked like she was about to faint.  pt started having seizures soon after.  paramedics were called.
Age: 18.0
Sex: F
Vaccine: COVID19
Symptoms: Pallor, Seizure, Syncope, Tremor, Unresponsive to stimuli
Clinical narrative: Systemic: Allergic: Difficulty Breathing-Medium, Systemic: Abdominal Pain-Medium, Systemic: Confusion-Medium, Systemic: Fainting / Unresponsive-Medium, Systemic: Flushed / Sweating-Medium, Systemic: Seizure-Medium, Systemic: Shakiness-Medium, Additional Details: patient developed symptoms about 5 minutes after receiving vaccine.  She started looking very pale and looked like she was about to faint.  pt started having seizures soon after.  paramedics were called.
Age: 20.0
Sex: F
Vaccine: COVID19
Symptoms: Molluscum contagiosum, Rash
Clinical narrative: Following my Pfizer Covid-19 vaccination, I soon developed bumps all over my vagina and thighs, later identified by a doctor as Molluscum Contagiosum (no tests were taken, he labeled it as Molluscum Contagiosum by looking). The bumps continued to spread to my arms and to my face and lastest for many months. I went to multiple doctors, had a laser treatment, used creams and oral medications from the pharmacy, used natural remedies such as apple cider vinegar, and was finally cleared in December 2021, six months after my vaccination.
Age: 51.0
Sex: F
Vaccine: COVID19
Symptoms: Mobility decreased
Clinical narrative: Systemic: Continued trouble moving arm-Medium
Age: 44.0
Sex: F
Vaccine: COVID19
Symptoms: Injection site pain
Clinical narrative: Site: Pain at Injection Site-Severe
Sex: U
Vaccine: MMRV
Symptoms: Product storage error
Clinical narrative: VARIVAX AND PROQUAD were administered after temperature excursion; This spontaneous report was received from a registered nurse referring to a patient of unknown age and gender. The patient's concurrent conditions, pertinent medical history, concomitant medications, drug reactions or allergies were no reported.   On an unknown date, the patient was vaccinated with Measles, Mumps, Rubella and Varicella (Oka-Merck) Virus Vaccine Live (PROQUAD) Lot# T032144 and expiration date 20-MAR-2022, Lot# T032144 expiration date 20-MAR-2022, Lot#T034610 and expiration date 10-APR-2022, and Lot# T034829 and expiration date 11-APR-2022 (exact dose, route of administration and frequency were not reported) as prophylaxis. On an unknown date, the patient was vaccinated with varicella virus vaccine live (Oka/Merck) (VARIVAX) lot#U016064 and expiration date 20-MAY-2023 as prophylaxis. It was reported that, VARIVAX AND PROQUAD were administered after temperature excursion (Product storage error). The vaccine underwent a temperature excursion of 14.3 degree Celsius for a period of 35 minutes. There was no previous temperature excursion.  The case is non-valid due to lack of patient identifier.
Sex: U
Vaccine: HPV9
Symptoms: Incomplete course of vaccination, No adverse event
Clinical narrative: patient who was previously administered the 1st and 2nd doses of gardasil 9 (unknown dates), had missed patient's 3rd dose; no additional AE reported; This spontaneous report was received from a pharmacist referring to a patient of unknown age and gender. No patient's pertinent medical history, concurrent conditions, drug reactions or allergies, nor concomitant therapies were reported.     On an unknown date, the patient was vaccinated with her/his first dose of hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast)(GARDASIL 9), (strength, dose, route, anatomical location, lot number and expiration date were not reported), for prophylaxis. On an unknown date, the patient was vaccinated with her/his second dose of hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast)(GARDASIL 9), (strength, dose, route, anatomical location, lot number and expiration date were not reported), for prophylaxis. On an unknown date, the patient had missed her/his third dose of hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast)(GARDASIL 9) (inappropriate schedule of product administration). No additional adverse event reported.
Sex: F
Vaccine: MMR
Symptoms: Expired product administered, No adverse event
Clinical narrative: No additional adverse event reported; M-M-R II with expiration date of 12-JAN-2022 was administered to a patient; This spontaneous report was received from a nurse practitioner concerning to a 13-month-child female patient. The patient's medical history, historical drugs, allergies, concurrent conditions and concomitant therapies were not provided.  On 13-JAN-2021, the patient was vaccinated with an expired dose of measles (+) mumps (+) rubella (wistar ra 27-3) virus vaccine, live (M-M-R II), lot # T001213, expiry date 12-JAN-2022 (dose, anatomical location, route of administration was not reported) for prophylaxis (expired product administered). No other adverse event reported.
Age: 41.0
Sex: F
Vaccine: HPV4
Symptoms: Incorrect route of product administration, Off label use
Clinical narrative: "off-label" use of quadrivalent HPV-L1 vaccine (Gardasil) for HPV-HR positive gynecological malignancies;   This literature marketed report was received from the authors in a published literature article titled as stated above, concerning a 41-year-old female patient, diagnosed with stage IIIB, HPV-HR positive, moderately differentiated squamous cell carcinoma of the cervix. The patient was treated with pelvic irradiation (4500 cGy) with concurrent cisplatin (40 mg/m2) followed by two low-dose-rate cesium brachytherapy implants (total 8500 cGy to Point A). By the second tandem and ovoid application, the cervical tumor had completely resolved. Four weeks (also reported as three weeks) after her second cesium application, the patient presented to the office complaining of vaginal discharge. An exam found a 3 to 4 cm recurrent, grade 1, squamous cell carcinoma. Positron emission tomography and computerized tomography (PET/CT) imaging documented an isolated central cervical cancer recurrence with no evidence of metastatic disease.   On an unknown date, 4 weeks after second cesium implant, the patient received the first intratumoral vaccination of quadrivalent human papillomavirus (types 6,11,16,18) recomb. vaccine (GARDASIL) 0.5 mL, using 0.25 mL of the vaccine diluted with 2.75 mL saline (total volume 3 ml) injected evenly throughout entire recurrent tumor, administered for with stage IIIB, HPV-HR positive, moderately differentiated squamous cell carcinoma of the cervix (Off-label- use) (lot #, and expiration date were not provided); which was was given followed by intravaginal 0.2% imiquimod suppositories every night until the second intratumoral injection 14 days later. On day 15, the patient received the same treatment as cycle # 1 (lot #, and expiration date were not provided). In addition, she received a subcutaneous injection in the right shoulder as a "booster" (dose, lot #, and expiration date were not provided). The patient received only 2 cycles, which she received 8 days before a planned exenterative surgery which was aborted.   A copy of the published article is attached as further documentation of the patient's experience.   This is one of two reports from the same literature article.; Sender's Comments:  US-009507513-2201HUN002212:
Sex: U
Vaccine: VARZOS
Symptoms: Herpes zoster, Vaccination failure
Clinical narrative: Vaccinated and I still have an outbreak/Suspected vaccination failure; Still have an outbreak; This case was reported by a consumer via interactive digital media and described the occurrence of suspected vaccination failure in a patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   The patient's past medical history included 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 was unknown and the outcome of the shingles was not recovered/not resolved.   It was unknown if the reporter considered the vaccination failure and shingles to be related to Shingles vaccine.  Additional details were provided as follows: The patient self-reported this case. The age at vaccination was not reported. The patient had complications from years ago and stated that shingles were terrible.  The patient reported that shot was not available when he/she got shingles. The patient was vaccinated with Shingles vaccine and still had an outbreak for time to time. The follow-up would not possible as no contact details were available. This case was considered as suspected vaccination failure since the details regarding completion of primary immunization schedule, time to onset and laboratory test confirming shingles were unknown at the time of reporting.
Sex: U
Vaccine: VARZOS, VARZOS
Symptoms: Herpes zoster, Illness, Vaccination failure
Clinical narrative: Got the 2shot vaccine yr ago, now shingles/suspected vaccination failure; Shingles; Got sicker than heck from them; This case was reported by a consumer via interactive digital media and described the occurrence of suspected vaccination failure in a patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   Co-suspect products included Herpes zoster (Shingles vaccine) for prophylaxis.   The patient's past medical history included shingles (had shingles 13 years ago from reporting date and it was horrible).   On an unknown date, the patient received the 2nd dose of Shingles vaccine and the 1st dose of Shingles vaccine. On an unknown date, 1 year after receiving Shingles vaccine and unknown after receiving Shingles vaccine, the patient experienced vaccination failure (serious criteria GSK medically significant), shingles and sickness. On an unknown date, the outcome of the vaccination failure and sickness were unknown and the outcome of the shingles was recovering/resolving.   It was unknown if the reporter considered the vaccination failure and shingles to be related to Shingles vaccine and Shingles vaccine. The reporter considered the sickness to be related to Shingles vaccine and Shingles vaccine.  Additional details were provided as follows: The patient self-reported this case. The age at vaccination was not reported. The patient received 2 shot Shingle vaccine a year ago from reporting date and got sicker than heck from them. The patient reported that it was been a year since he/she got last shot and ended up with a case of shingles that was worse than the first time he/she had them.  The patient reported that it was been 3 weeks now and finally got some relief. The patient reported, as it was worst case of shingles ever and Shingle shot did not work that great and he/she would never do it again. The follow-up would not possible as no contact details were available. This case was considered as suspected vaccination failure since the details regarding laboratory test confirming shingles was unknown at the time of reporting.
Sex: U
Vaccine: VARZOS
Symptoms: Herpes zoster, Vaccination failure
Clinical narrative: the shot doesn't keep you from getting shingles, I still get them/Suspected vaccination failure; still get them; This case was reported by a consumer via interactive digital media and described the occurrence of suspected  vaccination failure in a patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   On an unknown date, the patient received Shingles vaccine. On an unknown date, unknown after receiving Shingles vaccine, the patient experienced vaccination failure (serious criteria GSK medically significant) and shingles. On an unknown date, the outcome of the vaccination failure and shingles were unknown.   It was unknown if the reporter considered the vaccination failure and shingles to be related to Shingles vaccine.  Additional details were provided as follows: The case was self-reported by the patient. The age at vaccination was not reported. The patient received the Shingles vaccine and still gets shingles. The patient mentioned that did not take the shot, it did not keep you from getting shingles, the breakouts would not be bad.  The follow-up would not possible as no contact details were available. 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.
Sex: F
Vaccine: VARZOS
Symptoms: Cerebrovascular accident
Clinical narrative: stroke; This case was reported by a consumer via interactive digital media and described the occurrence of stroke in a female patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   On an unknown date, the patient received Shingles vaccine. On an unknown date, 1 week after receiving Shingles vaccine, the patient experienced stroke (serious criteria GSK medically significant). On an unknown date, the outcome of the stroke was unknown.   It was unknown if the reporter considered the stroke to be related to Shingles vaccine.  Additional details were provided as follows: The reporter was the patient's parent. The age at vaccination was not reported. The patient got Shingles shot and week later stroke. The reporter wanted to know if there was any connection. The follow-up would not be possible as no contact details were available.
Sex: U
Vaccine: VARZOS
Symptoms: Herpes zoster, Pain, Vaccination failure
Clinical narrative: had the shot an still got a mild case of shingles afterwards/ suspected vaccination failure; shingles; Very painful; This case was reported by a consumer via interactive digital media and described the occurrence of suspected vaccination failure in a patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   On an unknown date, the patient received Shingles vaccine. On an unknown date, unknown after receiving Shingles vaccine, the patient experienced vaccination failure (serious criteria GSK medically significant), shingles and pain. On an unknown date, the outcome of the vaccination failure, shingles and pain were unknown.   It was unknown if the reporter considered the vaccination failure, shingles and pain to be related to Shingles vaccine.  Additional details were provided as follows: The case was self-reported by the patient. The age at vaccination was not reported. The reporter stated that, he/she had the Shingles shot and still got a mild case of shingles afterwards. They were very painful.  The reporter also stated that, he/she would never get that shot again. The follow-up would not possible as no contact details were available. 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.
Sex: U
Vaccine: VARZOS
Symptoms: Incomplete course of vaccination
Clinical narrative: never got the 2nd shot; This case was reported by a physician via call center representative and described the occurrence of incomplete course of vaccination in an unspecified number of patients who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included Shingrix (1st dose received 3 to 4 years ago).   On an unknown date, the patient received the 2nd dose of Shingrix. On an unknown date, unknown after receiving Shingrix, the patient experienced incomplete course of vaccination. On an unknown date, the outcome of the incomplete course of vaccination was unknown.  Additional details were provided as follows: The age at vaccination was not applicable for this report. The reporter reported that his/her patients had a Shingrix 3 to 4 years before the date of reporting but never got the 2nd shot, which led to incomplete course of vaccination. The reporter had not provided further details provided on web form. The reporter consented to follow up. The case has been linked to US2020171344, reported by the same reporter.; Sender's Comments:  US-GLAXOSMITHKLINE-US2020171344:Same reporter
Age: 17.0
Sex: F
Vaccine: MENB
Symptoms: Decreased appetite, Nausea
Clinical narrative: daily nausea; Lack of appetite; This case was reported by a consumer via call center representative and described the occurrence of nausea in a 17-year-old female patient who received Men B NVS (Bexsero) 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 2nd December 2021, the patient received the 1st dose of Bexsero and Bexsero Pre-Filled Syringe Device. On 2nd December 2021, less than a day after receiving Bexsero and Bexsero Pre-Filled Syringe Device, the patient experienced nausea and appetite absent. On an unknown date, the outcome of the nausea and appetite absent were not recovered/not resolved.   It was unknown if the reporter considered the nausea and appetite absent to be related to Bexsero and Bexsero Pre-Filled Syringe Device. This report is made by GSK without prejudice and does not imply any admission or liability for the incident or its consequences.  Additional details were provided as follows: The reporter was the patient's mother. The patient received the first dose of Bexsero and since that day after receiving the vaccine, she experienced daily nausea and lack of appetite which had not resolved. The reporter stated the patient was still experiencing nausea at the time of reporting. The reporter wanted to know if this was a long term side effect from the vaccine. The patient stated she had only received first dose and had not gotten dose 2 because of the symptoms. The reporter stated that the patients next dose was scheduled for June and asked if this was correct, as she saw on the Bexsero website that the dose schedule was 1 month apart. The reporter consented to follow up.
Sex: U
Vaccine: VARZOS
Symptoms: Inappropriate schedule of product administration, Product supply issue
Clinical narrative: shortage that occurred; This case was reported by a other health professional via call center representative and described the occurrence of product supply issue in an unspecified number of patients who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included Shingrix (received 1st dose on an unknown date).   On an unknown date, the patient received the 2nd dose of Shingrix. On an unknown date, unknown after receiving Shingrix, the patient experienced product supply issue. On an unknown date, the outcome of the product supply issue was unknown.  Additional details were provided as follows: The age at vaccination was not applicable for this report. The reporter stated that, many patients who were late for the 2nd dose due to the shortage that occurred, which led to product supply issue. The reporter did not consent to follow up.
Age: 16.0
Sex: M
Vaccine: MNQ
Symptoms: Incorrect dose administered, Product preparation error
Clinical narrative: reconstituted with sterile water; reconstituted with 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 16-year-old male patient who received Men ACWY-CRM NVS (Menveo) (batch number amva689a, expiry date 20th October 2022) for prophylaxis.   On 18th January 2022, the patient received Menveo. On 18th January 2022, unknown after receiving Menveo, the patient experienced wrong solution used in drug reconstitution and inappropriate dose of vaccine administered. On an unknown date, the outcome of the wrong solution used in drug reconstitution and inappropriate dose of vaccine administered were unknown.  Additional details were provided as follows: The patient administered Menveo vaccine which was inadvertently reconstituted with sterile water, which led to wrong solution used in drug reconstitution and inappropriate dose of vaccine administered. The reporter consented to follow up.
Sex: U
Vaccine: HEPA
Symptoms: Underdose
Clinical narrative: pediatric dose of Havrix to an adult; pediatric dose of Havrix to an adult; first dose in 2019, second in 2022; This case was reported by a nurse via call center representative and described the occurrence of underdose in a adult patient who received HAV (Havrix pediatric) for prophylaxis.   Co-suspect products included hepatitis A vaccine pre-filled syringe device (Havrix Pre-Filled Syringe Device) injection syringe for prophylaxis.   Previously administered products included Havrix pediatric (received 1st dose in November 2019).   In January 2022, the patient received the 2nd dose of Havrix pediatric and Havrix Pre-Filled Syringe Device. In January 2022, unknown after receiving Havrix pediatric and Havrix Pre-Filled Syringe Device, the patient experienced underdose, adult use of a child product and drug dose administration interval too long. On an unknown date, the outcome of the underdose, adult use of a child product and drug dose administration interval too long were unknown.   This report is made by GSK without prejudice and does not imply any admission or liability for the incident or its consequences.  Additional details were provided as follows: The age at vaccination was not reported. The nurses from one of reporter's institution´s ambulatory clinic administered a pediatric dose of Havrix to an adult, which led to underdose, adult use of a child product. The patient received 2nd dose late than the recommended time interval, which led to lengthening of vaccination schedule. The reporter said that patient information was not available to her and that the ambulatory clinic staff had submitted a VAERS report for this incident. The reporter consented to follow up.
Sex: M
Vaccine: VARZOS
Symptoms: Herpes zoster, Vaccination failure
Clinical narrative: Suspected vaccination failure/Had Shingrix, has a case of Shingles; shingles; This case was reported by a physician via call center representative and described the occurrence of suspected vaccination failure in a male patient who received Herpes zoster (Shingrix) for prophylaxis.   On an unknown date, the patient received Shingrix. On an unknown date, more than 2 years after receiving Shingrix, 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 Shingrix.  Additional details were provided as follows: The age at vaccination was not reported. The patient received Shingrix and had a case of shingles (which confirm) at the time of reporting. The patient wanted to know if he should have Shingrix again since it had been over 4 years. The patient asked if there was any current guidance on whether a repeat series should be necessary in an immunocompetent patient and in his case, when would it be safe to gave another series if he wanted one and if it were not contraindicated. No further details were provided on web form. This case was considered as suspected vaccination failure as details regarding the completion of primary vaccination schedule and laboratory test confirmation were unknown at the time of reporting. The reporter consented to follow-up.
Sex: F
Vaccine: HEP
Symptoms: Incomplete course of vaccination
Clinical narrative: past due for dose two of Engerix-B; This case was reported by a pharmacist via call center representative and described the occurrence of incomplete course of vaccination in a female patient who received HBV (Engerix B adult) for prophylaxis.   Previously administered products included Engerix B adult (received 1st dose on an unknown date).   On an unknown date, the patient received the 2nd dose of Engerix B adult. On an unknown date, unknown after receiving Engerix B adult, the patient experienced incomplete course of vaccination. On an unknown date, the outcome of the incomplete course of vaccination was unknown.  Additional details were provided as follows: The age at vaccination was not applicable for this report. The patient was past due for 2nd dose of Engerix B, and till the time of reporting, did not receive 2nd dose of Engerix B, which led to incomplete course of vaccination. The reporter consented to follow up. This case was linked with case US2021251156, reported by same reporter.; Sender's Comments:  US-GLAXOSMITHKLINE-US2021251156:Same reporter
Sex: U
Vaccine: MENB, MENB
Symptoms: Extra dose administered
Clinical narrative: received Trumenba and Bexsero at same time; This case was reported by a nurse via call center representative and described the occurrence of overdose in a patient who received Men B NVS (Bexsero) 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 and MENINGOCOCCAL B VACCINE (TRUMENBA) for prophylaxis.   On an unknown date, the patient received Bexsero, Bexsero Pre-Filled Syringe Device and TRUMENBA. On an unknown date, unknown after receiving Bexsero and Bexsero Pre-Filled Syringe Device, the patient experienced overdose. On an unknown date, the outcome of the overdose was unknown.   This report is made by GSK without prejudice and does not imply any admission or liability for the incident or its consequences.  Additional details were provided as follows: The age at vaccination was not reported. The patient received Trumenba and Bexsero at same time, which led to overdose. The reporter did not consent to follow up.
Age: 5.0
Sex: M
Vaccine: DTAPIPV
Symptoms: Expired product administered
Clinical narrative: Administered expired Kinrix; This case was reported by a nurse via call center representative and described the occurrence of expired vaccine used in a 5-year-old male patient who received DTPa-IPV (Kinrix) (batch number 3DZ45, expiry date 15th January 2022) for prophylaxis.   Co-suspect products included dtpa-ipv vaccine pre-filled syringe device (Kinrix Pre-Filled Syringe Device) injection syringe for prophylaxis.   On 21st January 2022, the patient received Kinrix and Kinrix Pre-Filled Syringe Device. On 21st January 2022, unknown after receiving Kinrix and Kinrix Pre-Filled Syringe Device, the patient experienced expired vaccine used. On an unknown date, the outcome of the expired vaccine used was unknown.   This report is made by GSK without prejudice and does not imply any admission or liability for the incident or its consequences.  Additional details were provided as follows: The patient received expired dose of Kinrix, which led to expired vaccine used. The patient was not been redosed. The reporter consented to follow up.
Sex: M
Vaccine: COVID19
Symptoms: Death, Heart rate, SARS-CoV-2 test
Clinical narrative: WITHOUT A PULSE NOR HEARTBEAT (DEATH); This spontaneous report received from a health care professional concerned a 78 year old male of an unspecified race and ethnic origin. The patient's height, and weight were not reported. The patient's concurrent conditions included: advanced parkinson's disease, hyperlipidemia, anxiety, vitamin D deficiency, vascular dementia, hypothyroidism, major depressive disorder and aphasia. The patient previously received covid-19 vaccine ad26. cov2.s (suspension for injection, route of administration, batch number were not reported, expiry: unknown) dose was not reported, (dose number in series was 1), 01 in total was administered on 05-MAY-2021 for prophylactic vaccination. The reporter did not report any adverse events following covid-19 vaccine ad26. cov2.s vaccination. The patient was admitted to facility on 14-DEC-2021 for nursing care due to advanced Parkinson's Disease, hyperlipidemia, anxiety, vitamin D deficiency, vascular dementia, hypothyroidism, major depressive disorder and aphasia. On an unspecified date in DEC-2021, outbreak COVID 19 testing revealed negative tests on the resident throughout course of the stay. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, intramuscular, batch number: 213D21A, expiry: 11-APR-2022) 0.5 ml, (dose number in series was 2), 01 in total was administered on 15-DEC-2021 for prophylactic vaccination. No concomitant medications were reported. On 17-DEC-2021, following the vaccination with covid-19 vaccine ad26.cov2.s, at approximately 11:44 hours, he was found without a pulse nor heartbeat (death) (dose number in series was 2). It was not reported whether autopsy was performed or not. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of without a pulse nor heartbeat (death) was fatal (dose number in series was 2). This report was serious (Death). This case, from the same reporter is linked to 20220124404 and 20220130332.; Sender's Comments: V0-20220124221-covid-19 vaccine ad26.cov2.s-without a pulse nor heartbeat (death). This event(s) is considered unassessable. The event(s) has a compatible/suggestive temporal relationship, is unlabeled, and has unknown scientific plausibility. There is no information on any other factors potentially associated with the event(s).; Reported Cause(s) of Death: WITHOUT A PULSE NOR HEARTBEAT (DEATH)
Sex: F
Vaccine: COVID19, COVID19
Symptoms: SARS-CoV-2 test, Suspected COVID-19, Tinnitus, Vaccination failure
Clinical narrative: SUSPECTED CLINICAL VACCINATION FAILURE; SUSPECTED COVID-19 INFECTION; CRACKLY EARS; This spontaneous report received from a patient concerned a female of unspecified age. The patient's height and weight were not reported. The patient's concurrent conditions included drug allergy (Ibuprofen). The patient was previously vaccinated with covid-19 vaccine ad26.cov2.s (suspension for injection, route of administration was not reported, batch number: 1805029 and expiry: unknown) dose was not reported, (dose number in series 1) 01 in total administered on 16-MAR-2021 to left arm for prophylactic vaccination. No concomitant medications were reported.  The patient additionally received non-company suspect vaccine included: Pfizer covid-19 vaccine (bnt 162) (suspension for injection, intramuscular, batch number: FJ8762 and expiry: unknown) dose was not reported, (dose number in series 2) administered on 04-JAN-2022 for prophylactic vaccination. No concomitant medications were reported.  On 11-JAN-2022, the patient had suspected covid-19 infection (cough, head congestion/clogged head, sinus pain and runny nose) and had suspected clinical vaccination failure (dose number in series 1). On 11-JAN-2022, the following vaccination with Pfizer covid-19 vaccine the patient experienced crackly ears (dose number in series 2).  On 12-JAN-2022, Laboratory data included: COVID-19 antigen test (NR: not provided) Positive. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from crackly ears (dose number in series 2), and the outcome of suspected covid-19 infection and suspected clinical vaccination failure was not reported (dose number in series 1). This report was serious (Other Medically Important Condition). This report was associated with product quality complaint: 90000213204.; Sender's Comments: V0:20220126728-COVID-19 VACCINE AD26.COV2.S-Suspected clinical vaccination failure. This event(s) is considered not related. The event(s) has a compatible/suggestive temporal relationship, is unlabeled, and has unknown scientific plausibility. There are other factors more likely to be associated with the event(s) than the drug. Specifically: SPECIAL SITUATIONS
Sex: M
Vaccine: COVID19
Symptoms: Cerebrovascular accident, Renal failure, SARS-CoV-2 test, Suspected COVID-19, Vaccination failure
Clinical narrative: KIDNEY FAILURE; SUSPECTED CLINICAL VACCINATION FAILURE; SUSPECTED COVID-19 INFECTION; STROKE; This spontaneous report received from a physician concerned a 75 year old male (Retired Physician). The patient's height, and weight were not reported. The patient's concurrent conditions included: multiple myeloma, and cited multiple melanoma, and other pre-existing medical conditions included: Patient had no known allergies. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: UNKNOWN) dose was not reported, 1 total, administered on an unspecified date in 2021 for prophylactic vaccination. The batch number was not reported and has been requested. No concomitant medications were reported.  On an unspecified date, the patient had kidney failure and he was on dialysis for kidney failure. On 05-JAN-2022, the patient got COVID (captured as suspected covid-19 infection and hence suspected clinical vaccination failure), 2 days after his wife got positive for COVID-19. Laboratory data included: COVID-19 virus test (NR: not provided) Positive. Reporter called about Paxlovid but they had not taken Paxlovid yet, reporter said she called to get help, she got infected by a patient as she was a physician and then her husband (Patient) got it, they wanted to get information about how to get the Paxlovid medication. The reporter said that patient also had a good positive experience with no allergic reaction to his COVID-19 vaccine. On an unspecified date in earlier this year JAN-2022, the patient had a stroke.  The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from kidney failure, and the outcome of suspected covid-19 infection, stroke and suspected clinical vaccination failure was not reported. This report was serious (Other Medically Important Condition). This report was associated with product quality complaint.; Sender's Comments: V0: 20220132972- covid-19 vaccine ad26.cov2.s  kidney failure, stroke. This event(s) is considered unassessable. The event(s) has a compatible/suggestive temporal relationship, is unlabeled, and has unknown scientific plausibility. There is no information on any other factors potentially associated with the event(s).  20220132972-COVID-19 VACCINE AD26.COV2.S-Suspected clinical vaccine failure. This event is considered not related. The event has a compatible/suggestive temporal relationship, is unlabeled, and has unknown scientific plausibility. There are other factors more likely to be associated with the event than the drug. Specifically: SPECIAL SITUATIONS.