chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 48.0
Sex: F
Vaccine: COVID19, COVID19, COVID19, COVID19
Symptoms: Vaccine breakthrough infection, Vomiting, White blood cell count normal
Clinical narrative: BREAKTHROUGH COVID: PT FULLY VACCINATED WITH 2 BOOSTERS: PT HAD FAMILY EXPOSURE AND SYMPTOMATIC WITH POSITIVE AB FOR COVID.   She has tested multiple times negative for COVID in the last week.  All her family has been testing positive.  She took Paxlovid as an outpatient and is almost done.  She has felt very weak for several days and has had a constant headache.  She has been taking naproxen, zofram around the clock.  She has only had nausea and vomiting today.    Denies seizures, denies diarrhea.  Positive cough, hard to bring any secretions which are clear.  Positive rigors and chills. ED lab results showed critical Na+ at 114. Patient was admitted to the ICU due to critical hyponatremia.
Age: 64.0
Sex: F
Vaccine: COVID19
Symptoms: Acute respiratory failure, Chronic respiratory failure, Respiratory failure
Clinical narrative: CHRONIC HYPOXEMIC RESPIRATORY FAILURE 12/1/2022, ACUTE ON CHRONIC HYPERCAPNIC RESPIRATORY FAILURE
Age: 1.0
Sex: M
Vaccine: MMR
Symptoms: Pyrexia, Rash
Clinical narrative: fever x3 days rash x5 days no treatment needed
Age: 70.0
Sex: F
Vaccine: COVID19-2
Symptoms: COVID-19, Cough, Dizziness, Headache, Nasopharyngitis
Clinical narrative: On 11/21/20222 I had headache, scratchy throat. I tested positive on 11/22/2022 using a home COVID-19 test.  After testing positive  I had more symptoms such as  a fever, cough, body aches and head cold. I did a telehealth on the same day with  my doctor who then  prescribed me with Paxlovid for 5 days. I did a home test 11/30/2022 which was negative. After 5 days on 12/04/2022 I tested positive again. I had a rebound case of COVID-19. I woke up with a scratchy throat in the morning. I was light headed for 1 week. This time I didn't take any medication I got better in a week.
Age: 70.0
Sex: F
Vaccine: COVID19-2
Symptoms: Pain, Pyrexia, SARS-CoV-2 test positive, Throat irritation
Clinical narrative: On 11/21/20222 I had headache, scratchy throat. I tested positive on 11/22/2022 using a home COVID-19 test.  After testing positive  I had more symptoms such as  a fever, cough, body aches and head cold. I did a telehealth on the same day with  my doctor who then  prescribed me with Paxlovid for 5 days. I did a home test 11/30/2022 which was negative. After 5 days on 12/04/2022 I tested positive again. I had a rebound case of COVID-19. I woke up with a scratchy throat in the morning. I was light headed for 1 week. This time I didn't take any medication I got better in a week.
Age: 50.0
Sex: M
Vaccine: COVID19
Symptoms: Deep vein thrombosis
Clinical narrative: ACUTE DVT OF RIGHT LEG, UNSPECIFIED VEIN ACUTE DVT OF LEFT LEG, UNSPECIFIED VEIN
Age: 70.0
Sex: F
Vaccine: COVID19
Symptoms: Hypoglycaemia, Hypotension, Pneumonia
Clinical narrative: I95.9 HYPOTENSION 12/1/2022 HYPOGLYCEMIA I95.9 HYPOTENSION 12/1/2022 BILAT PNEUMONIA
Age: 66.0
Sex: M
Vaccine: COVID19
Symptoms: Hypoxia
Clinical narrative: HYPOXIA
Age: 93.0
Sex: F
Vaccine: COVID19
Symptoms: Cerebrovascular accident, Hypercoagulation, Hypertension
Clinical narrative: I63.9 ACUTE STROKE, UNSPECIFIED TYPE AND ARTERY 2/23/2022 LATE EFFECT OF STROKE I63.9 ACUTE STROKE, UNSPECIFIED TYPE AND ARTERY 2/23/2022 HTN (HYPERTENSION) I63.9 ACUTE STROKE, UNSPECIFIED TYPE AND ARTERY 2/23/2022 SECONDARY HYPERCOAGULABLE STATE
Age: 63.0
Sex: M
Vaccine: COVID19
Symptoms: Hypotension
Clinical narrative: HYPOTENSION
Age: 33.0
Sex: F
Vaccine: COVID19
Symptoms: Acne, Blister, Rash erythematous
Clinical narrative: On 11/03/2021, the day after receiving my vaccine, I notice what looked like pimples or little blisters on my upper chest. It then developed into a red rash all around. It got worse overnight and into the next day. When I went into the urgent care, the doctor said it was a reaction from the vaccine because I had not waited long enough to receive my vaccine after using steroids for my asthma. They gave me a steroid injection and also was put back on oral steroids for a few days. It resolved after that.
Age: 74.0
Sex: F
Vaccine: COVID19-2
Symptoms: Condition aggravated, Deafness, Tinnitus
Clinical narrative: I have had tinnitus for many years, however 24 hours after receiving my 2nd bivalent Covid vaccine the tinnitus became significantly worse.  I have an appointment coming up with an audiologist for testing and treatment and also an appointment with my ent provider.  I also have a hearing loss that occurred. A couple months after receiving my  3rd Covid vaccine.  I have filed a separate Baer?s report  temporary Vader?s e-report number 967105
Age: 3.0
Sex: M
Vaccine: DTAPIPV, PNC13
Symptoms: Product administered to patient of inappropriate age
Clinical narrative: Kinrix given, but patient is not 4 years old.  No incident at time of vaccine. Unable to get call back from parent on any adverse effects.
Age: 76.0
Sex: M
Vaccine: COVID19-2
Symptoms: Ear pain
Clinical narrative: I had some right ear pain, I made an appointment to go in and see an ENT. He examined my ear did not find that I had an infection. He gave me steroid ear drops that I am not completely sure if they have helped or not as I had been taking Augmentin earlier.
Age: 58.0
Sex: F
Vaccine: COVID19
Symptoms: Biopsy breast, Breast cancer female, Breast cancer stage I, Mammogram abnormal, Radiotherapy
Clinical narrative: Cancer was discovered in the left breast during a routine mammogram.  Doctor recommended a partial mastectomy.  No Lymph node involvement, no chemo, just radiation.  Cancer was stage 1B.
Age: 74.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site inflammation, Injection site pain, Injection site swelling
Clinical narrative: Pain and inflammation at injection site beginning at night on the day following the injection.  Inflammation involved swelling approximately 6 inches in diameter and raised off the skin approximately 1 to 2 inches.  Inflammation was painful.  Symptoms resolved by 5-22-23.
Age: 65.0
Sex: F
Vaccine: COVID19-2
Symptoms: Blood test, Chest X-ray, Computerised tomogram, Cough, Dyspnoea
Clinical narrative: My wife started experiencing a high fever (105.1) shortness of breath, dry cough, and fatigue.
Age: 65.0
Sex: F
Vaccine: COVID19-2
Symptoms: Echocardiogram, Electrocardiogram, Fatigue, Pyrexia, Ultrasound pelvis
Clinical narrative: My wife started experiencing a high fever (105.1) shortness of breath, dry cough, and fatigue.
Age: 82.0
Sex: M
Vaccine: COVID19-2
Symptoms: Asthenia, Erythema, Fatigue, Myalgia, Pyrexia
Clinical narrative: Fever of 101, red face, rash all over body, muscle aches, lack of energy, fatigue.  Treated with Prednisone for rash. The rash is a little better. No fever.
Age: 82.0
Sex: M
Vaccine: COVID19-2
Symptoms: Rash
Clinical narrative: Fever of 101, red face, rash all over body, muscle aches, lack of energy, fatigue.  Treated with Prednisone for rash. The rash is a little better. No fever.
Age: 75.0
Sex: F
Vaccine: COVID19-2
Symptoms: Chest X-ray normal, Chest discomfort, Productive cough
Clinical narrative: I started having really bad productive cough that was bringing up a lot of junk. There are times my chest is tight but most times my I am coughing a lot of stuff up. I had a virtual visit the first time, I was prescribed a Medrol dose pack that helped some. By the weekend I still was not feeling any better, I went an Urgent Care, she listened to my chest, prescribed, an antibiotic and advised that I get an expectorant like Mucinex DM. I am starting to feel better, I will be following up with my PCP soon.
Age: 1.42
Sex: F
Vaccine: COVID19-2
Symptoms: Incorrect dose administered, Product preparation issue
Clinical narrative: Provider administered incorrect dosage to patient (17 month old) by giving too much of the vaccine. The COVID-19 bivalent vaccine appropriate for 6 months to 4 years old was grabbed and the provider withdrew 0.2 ml from the vial. After drawing medication, it was administered to the patient. However, the provider did not know that this vial for 6 month to 4 year olds needed to be reconstituted. The provider thought the vaccine was already reconstituted like the adult version of the vaccine. This was the first time the provider was administering the COVID-19 vaccine to a toddler after the implementation of the color-coded vials which is why the provider thought it was the same process other than administering a different dose. The error was discovered when another provider was going to label the vial to display how many dosages would be remaining. As the second provider was going to put the label on the vial, she noticed there was not as much vaccine left compared to what should have been in there. Once the error was discovered, the patient's mother was notified. The provider that administered the vaccine does not frequently administer vaccines, but instead works in a different program and has other job duties. However, it is a requirement from the workplace that this provider and all other nurses who do not already work in the clinic work there once a month. This is also why the administering provider was not familiar with the procedures associate with the different types of the COVID-19 vaccines available in relation to age group and reconstitution. Recommendations to prevent future errors is to encourage the provider and other staff members to ask as many questions as they need in order to confidently administer vaccines correctly. This provider did ask questions, but did not ask questions in relation to the dose or reconstituting the vaccine. Another recommendation would be to have the staff members that work in the clinic once a month do certain vaccine types rather than everything that is available because it is hard for them to keep track of the changing procedures or remember everything since they aren't down there frequently.
Age: 78.0
Sex: F
Vaccine: COVID19-2
Symptoms: COVID-19, Chest pain, Cough, Fatigue, Nausea
Clinical narrative: In late December 2022, she was nauseous and vomiting.  She had terrible head congestion and coughed so much her chest hurt.  She thought she had broken a rib.  She visited the urgent care on December 31, 2022, and received Paxlovid and took half doses as prescribed.  She felt better.  It took her an additional two weeks to completely recover.  She was extremely fatigued.
Age: 78.0
Sex: F
Vaccine: COVID19-2
Symptoms: Respiratory tract congestion, SARS-CoV-2 test positive, Vomiting
Clinical narrative: In late December 2022, she was nauseous and vomiting.  She had terrible head congestion and coughed so much her chest hurt.  She thought she had broken a rib.  She visited the urgent care on December 31, 2022, and received Paxlovid and took half doses as prescribed.  She felt better.  It took her an additional two weeks to completely recover.  She was extremely fatigued.
Age: 38.0
Sex: F
Vaccine: COVID19
Symptoms: No adverse event, Wrong product administered
Clinical narrative: Pfizer Comirnaty monovalent inadvertently given. No side effects reported.
Age: 24.0
Sex: F
Vaccine: COVID19-2, HEPAB, TDAP, VARCEL
Symptoms: Confusional state, Dyskinesia, Fear, Hyperhidrosis, Loss of consciousness
Clinical narrative: Patient lost consciousness for 5 to 10 seconds, legs kicked and moved during unconscious state. Patient then came to and did not know where they were and stated was scared. Patient also appeared very pale sweating.
Age: 24.0
Sex: F
Vaccine: COVID19-2, HEPAB, TDAP, VARCEL
Symptoms: Pallor
Clinical narrative: Patient lost consciousness for 5 to 10 seconds, legs kicked and moved during unconscious state. Patient then came to and did not know where they were and stated was scared. Patient also appeared very pale sweating.
Age: 36.0
Sex: M
Vaccine: COVID19-2
Symptoms: Anosmia, COVID-19, Chest pain, Choking, Cough
Clinical narrative: On 2/23/2023, I woke up coughing and with a runny nose and a sore throat. I thought that maybe it was just sinus trouble at first, but the symptoms rapidly worsened. By that evening, the symptoms were much worse; I sometimes was not able to breathe without coughing. Anytime I tried to take a breath, I would get choked up. On 2/23/2023, I took two home antigen tests and got positive results on both of them. About a week after the onset of symptoms, I got to the point where I had chest pains and fatigue that was so severe that I couldn't walk very far without feeling like I would collapse. On 3/3/2023, I went to an urgent care clinic, because my symptoms had not improved. All of the OTC medicines I had taken failed to work. At the urgent care, I was told to go to the ER if my symptoms worsened. The urgent care gave me Tessalon Perles, a Z-Pak, an albuterol inhaler, and amoxicillin. The medicines they prescribed me didn't help at all, so I ended up going to the ER on 3/9/2023. By this point, my cough had gotten worse. At the ER, I was given a breathing treatment and an evaluation. I was prescribed cough syrup, another round of steroids, and more antibiotics. I was pretty much prescribed the same antibiotics as the ones I had been prescribed at the urgent care, only they were much stronger. I tested negative on a home antigen test on 3/12/2023, and I returned to work on 3/13/2023. However, I still had symptoms, such as runny nose and coughing. About a week after returning to work, I experienced partial loss of smell, which lasted for a week. At one point, my coughing and sneezing were so violent that I experienced temporary nerve damage in the lower right side of my back, and this put me out of work for two days. When I returned to work after that, I was not allowed to lift anything above 10 lbs. for two weeks. The coughing, sneezing, and runny nose lasted until about the third week of April 2023. After those symptoms resolved, I felt fine.
Age: 36.0
Sex: M
Vaccine: COVID19-2
Symptoms: Dizziness, Dyspnoea, Fatigue, Gait disturbance, Impaired work ability
Clinical narrative: On 2/23/2023, I woke up coughing and with a runny nose and a sore throat. I thought that maybe it was just sinus trouble at first, but the symptoms rapidly worsened. By that evening, the symptoms were much worse; I sometimes was not able to breathe without coughing. Anytime I tried to take a breath, I would get choked up. On 2/23/2023, I took two home antigen tests and got positive results on both of them. About a week after the onset of symptoms, I got to the point where I had chest pains and fatigue that was so severe that I couldn't walk very far without feeling like I would collapse. On 3/3/2023, I went to an urgent care clinic, because my symptoms had not improved. All of the OTC medicines I had taken failed to work. At the urgent care, I was told to go to the ER if my symptoms worsened. The urgent care gave me Tessalon Perles, a Z-Pak, an albuterol inhaler, and amoxicillin. The medicines they prescribed me didn't help at all, so I ended up going to the ER on 3/9/2023. By this point, my cough had gotten worse. At the ER, I was given a breathing treatment and an evaluation. I was prescribed cough syrup, another round of steroids, and more antibiotics. I was pretty much prescribed the same antibiotics as the ones I had been prescribed at the urgent care, only they were much stronger. I tested negative on a home antigen test on 3/12/2023, and I returned to work on 3/13/2023. However, I still had symptoms, such as runny nose and coughing. About a week after returning to work, I experienced partial loss of smell, which lasted for a week. At one point, my coughing and sneezing were so violent that I experienced temporary nerve damage in the lower right side of my back, and this put me out of work for two days. When I returned to work after that, I was not allowed to lift anything above 10 lbs. for two weeks. The coughing, sneezing, and runny nose lasted until about the third week of April 2023. After those symptoms resolved, I felt fine.
Age: 36.0
Sex: M
Vaccine: COVID19-2
Symptoms: Nerve injury, Oropharyngeal pain, Rhinorrhoea, SARS-CoV-2 test positive, Sneezing
Clinical narrative: On 2/23/2023, I woke up coughing and with a runny nose and a sore throat. I thought that maybe it was just sinus trouble at first, but the symptoms rapidly worsened. By that evening, the symptoms were much worse; I sometimes was not able to breathe without coughing. Anytime I tried to take a breath, I would get choked up. On 2/23/2023, I took two home antigen tests and got positive results on both of them. About a week after the onset of symptoms, I got to the point where I had chest pains and fatigue that was so severe that I couldn't walk very far without feeling like I would collapse. On 3/3/2023, I went to an urgent care clinic, because my symptoms had not improved. All of the OTC medicines I had taken failed to work. At the urgent care, I was told to go to the ER if my symptoms worsened. The urgent care gave me Tessalon Perles, a Z-Pak, an albuterol inhaler, and amoxicillin. The medicines they prescribed me didn't help at all, so I ended up going to the ER on 3/9/2023. By this point, my cough had gotten worse. At the ER, I was given a breathing treatment and an evaluation. I was prescribed cough syrup, another round of steroids, and more antibiotics. I was pretty much prescribed the same antibiotics as the ones I had been prescribed at the urgent care, only they were much stronger. I tested negative on a home antigen test on 3/12/2023, and I returned to work on 3/13/2023. However, I still had symptoms, such as runny nose and coughing. About a week after returning to work, I experienced partial loss of smell, which lasted for a week. At one point, my coughing and sneezing were so violent that I experienced temporary nerve damage in the lower right side of my back, and this put me out of work for two days. When I returned to work after that, I was not allowed to lift anything above 10 lbs. for two weeks. The coughing, sneezing, and runny nose lasted until about the third week of April 2023. After those symptoms resolved, I felt fine.
Age: 70.0
Sex: F
Vaccine: VARZOS
Symptoms: Dizziness, Dyspnoea, Fatigue, Full blood count, Headache
Clinical narrative: severe fatigue, dizziness, headache, shortness of breath,  itchy rash on lower extremities and buttocks
Age: 70.0
Sex: F
Vaccine: VARZOS
Symptoms: Rash, Rash pruritic
Clinical narrative: severe fatigue, dizziness, headache, shortness of breath,  itchy rash on lower extremities and buttocks
Age: 54.0
Sex: F
Vaccine: COVID19
Symptoms: Urticaria
Clinical narrative: Severe hives
Age: 78.0
Sex: M
Vaccine: COVID19
Symptoms: Acute kidney injury, Acute respiratory failure, Dyspnoea, Hypotension, Hypovolaemic shock
Clinical narrative: I95.9 HYPOTENSION 1/3/2023 SHORTNESS OF BREATH J96.21 ACUTE ON CHRONIC HYPOXEMIC RESPIRATORY FAILURE 12/3/2022 SHORTNESS OF BREATH J96.90 RESPIRATORY FAILURE, UNSPECIFIED ACUITY 1/3/2023 SHORTNESS OF BREATH R57.1 HYPOVOLEMIC SHOCK 12/3/2022 SHORTNESS OF BREATH R57.9 SHOCK, UNSPECIFIED 1/3/2023 SHORTNESS OF BREATH I95.9 HYPOTENSION 1/3/2023 ACUTE HYPOXEMIC RESPIRATORY FAILURE    NONTRAUMATIC ACUTE KIDNEY INJURY J96.21 ACUTE ON CHRONIC HYPOXEMIC RESPIRATORY FAILURE 12/3/2022 ACUTE HYPOXEMIC RESPIRATORY FAILURE    NONTRAUMATIC ACUTE KIDNEY INJURY J96.90 RESPIRATORY FAILURE, UNSPECIFIED ACUITY 1/3/2023 ACUTE HYPOXEMIC RESPIRATORY FAILURE    NONTRAUMATIC ACUTE KIDNEY INJURY R57.1 HYPOVOLEMIC SHOCK 12/3/2022 ACUTE HYPOXEMIC RESPIRATORY FAILURE    NONTRAUMATIC ACUTE KIDNEY INJURY R57.9 SHOCK, UNSPECIFIED 1/3/2023 ACUTE HYPOXEMIC RESPIRATORY FAILURE    NONTRAUMATIC ACUTE KIDNEY INJURY
Age: 78.0
Sex: M
Vaccine: COVID19
Symptoms: Respiratory failure, Shock
Clinical narrative: I95.9 HYPOTENSION 1/3/2023 SHORTNESS OF BREATH J96.21 ACUTE ON CHRONIC HYPOXEMIC RESPIRATORY FAILURE 12/3/2022 SHORTNESS OF BREATH J96.90 RESPIRATORY FAILURE, UNSPECIFIED ACUITY 1/3/2023 SHORTNESS OF BREATH R57.1 HYPOVOLEMIC SHOCK 12/3/2022 SHORTNESS OF BREATH R57.9 SHOCK, UNSPECIFIED 1/3/2023 SHORTNESS OF BREATH I95.9 HYPOTENSION 1/3/2023 ACUTE HYPOXEMIC RESPIRATORY FAILURE    NONTRAUMATIC ACUTE KIDNEY INJURY J96.21 ACUTE ON CHRONIC HYPOXEMIC RESPIRATORY FAILURE 12/3/2022 ACUTE HYPOXEMIC RESPIRATORY FAILURE    NONTRAUMATIC ACUTE KIDNEY INJURY J96.90 RESPIRATORY FAILURE, UNSPECIFIED ACUITY 1/3/2023 ACUTE HYPOXEMIC RESPIRATORY FAILURE    NONTRAUMATIC ACUTE KIDNEY INJURY R57.1 HYPOVOLEMIC SHOCK 12/3/2022 ACUTE HYPOXEMIC RESPIRATORY FAILURE    NONTRAUMATIC ACUTE KIDNEY INJURY R57.9 SHOCK, UNSPECIFIED 1/3/2023 ACUTE HYPOXEMIC RESPIRATORY FAILURE    NONTRAUMATIC ACUTE KIDNEY INJURY
Age: 51.0
Sex: F
Vaccine: PNC20, PPV
Symptoms: Wrong product administered
Clinical narrative: Patient was given both the PCV 20 and PPSV 23 on the same day.  Did not need the PPSV 23.
Age: 4.0
Sex: F
Vaccine: DTAPIPV, MMR
Symptoms: Erythema, Pharyngitis streptococcal, Pyrexia, Rash, Streptococcal infection
Clinical narrative: AS PER THE MOTHER 24 HRS AFTER VACCINATION, SHE WAS SEEM IN THE ER AT HOSPITAL. THE PATIENT DEVELOPED HIVES AND ERYTHEMA ON THE FACE AND LEFT ARM, IN ADDITION, THE PATIENT DEVELOPED A FEVER OF 104 WHICH LASTED FOR 4 DAYS BUT WAS RESOLVED ON THE DATE OF FOLLOW-UP VISIT ON 02/25/2023. THE PATIENT WAS TREATED WITH BENADRYL FOR 3DAYS, RASH ALSO RESOLVED.
Age: 4.0
Sex: F
Vaccine: DTAPIPV, MMR
Symptoms: Streptococcus test positive, Urticaria
Clinical narrative: AS PER THE MOTHER 24 HRS AFTER VACCINATION, SHE WAS SEEM IN THE ER AT HOSPITAL. THE PATIENT DEVELOPED HIVES AND ERYTHEMA ON THE FACE AND LEFT ARM, IN ADDITION, THE PATIENT DEVELOPED A FEVER OF 104 WHICH LASTED FOR 4 DAYS BUT WAS RESOLVED ON THE DATE OF FOLLOW-UP VISIT ON 02/25/2023. THE PATIENT WAS TREATED WITH BENADRYL FOR 3DAYS, RASH ALSO RESOLVED.
Age: 64.0
Sex: F
Vaccine: COVID19
Symptoms: Anxiety, Blood pressure increased, Cytokine increased, Dysphagia, Heart rate increased
Clinical narrative: October 2021 - total body vibrations November and December 2021 vibrations continued. January 2022- insomnia  and anxiety February 2022- anxiety and insomnia continued with periods of elevated heart rate for no reason.. March onward all above symptoms continued plus difficulty swallowing in June 2022.  Dr had noted elevated brain cytokines in  brain. Elevated Interleukin 4 and 6 elevated. All above symptoms continued, weight loss of 35 lbs, with extreme anxiety and insomnia to continue, along with elevated blood pressure. Hospitalized 4 times in 2022 with Covid Vaccine reactions. Thesis is vaccine crossed blood brain barrier and caused brain inflammation.
Age: 64.0
Sex: F
Vaccine: COVID19
Symptoms: Insomnia, Interleukin level increased, Noninfective encephalitis, Vibratory sense increased, Weight decreased
Clinical narrative: October 2021 - total body vibrations November and December 2021 vibrations continued. January 2022- insomnia  and anxiety February 2022- anxiety and insomnia continued with periods of elevated heart rate for no reason.. March onward all above symptoms continued plus difficulty swallowing in June 2022.  Dr had noted elevated brain cytokines in  brain. Elevated Interleukin 4 and 6 elevated. All above symptoms continued, weight loss of 35 lbs, with extreme anxiety and insomnia to continue, along with elevated blood pressure. Hospitalized 4 times in 2022 with Covid Vaccine reactions. Thesis is vaccine crossed blood brain barrier and caused brain inflammation.
Age: 62.0
Sex: F
Vaccine: COVID19
Symptoms: Abnormal faeces, Diarrhoea, Faeces discoloured
Clinical narrative: Last year not long after receiving the vaccine I started going from what I can only describe as cow pie bowel movements or the runs. If I eat something that has a bit of grease two days in a row, I will have the runs. No matter what I eat, my bowel movements have a terrible smell to them. The color of my bowel movements is very distinct also, when they are the cow pie, they are very brown, when it's the runs the color is yellow. I finally have an appointment to see a gastroenterologist.
Age: 56.0
Sex: F
Vaccine: PNC20
Symptoms: Product administration error
Clinical narrative: Was not medically necessary at that age as patient was no longer a smoker
Age: 26.0
Sex: F
Vaccine: COVID19
Symptoms: Blood glucose, Blood test abnormal, Intermenstrual bleeding, Polycystic ovaries, Secretion discharge
Clinical narrative: In November 2022, I noticed after my period I began having spotting for an additional 10 days. My natural family planning instructor saw my charts and referred to a specialist doctor.  I had glucose testing.  I was diagnosed with PCOS - Polycystic ovary syndrome.  I had a Vitamin D deficiency and excessive mucus.  I am on a treatment plan now.
Age: 26.0
Sex: F
Vaccine: COVID19
Symptoms: Vitamin D deficiency
Clinical narrative: In November 2022, I noticed after my period I began having spotting for an additional 10 days. My natural family planning instructor saw my charts and referred to a specialist doctor.  I had glucose testing.  I was diagnosed with PCOS - Polycystic ovary syndrome.  I had a Vitamin D deficiency and excessive mucus.  I am on a treatment plan now.
Age: 67.0
Sex: M
Vaccine: PNC20
Symptoms: Inappropriate schedule of product administration
Clinical narrative: PCV given too soon after PCV13
Sex: M
Vaccine: HEPA, MMR, VARCEL
Symptoms: Diarrhoea, Inappropriate schedule of product administration
Clinical narrative: Administered before due date
Age: 66.0
Sex: F
Vaccine: PPV
Symptoms: Wrong product administered
Clinical narrative: Given PPSV23 and should have been a PCV20
Age: 76.0
Sex: M
Vaccine: COVID19
Symptoms: Acute respiratory failure, Asthenia, Dementia Alzheimer's type, Hypotension, Sleep apnoea syndrome
Clinical narrative: G47.30 SLEEP APNEA 11/27/2022 WEAKNESS I95.9 HYPOTENSION 11/27/2022 WEAKNESS J96.00 ACUTE RESPIRATORY FAILURE 11/27/2022 WEAKNESS G47.30 SLEEP APNEA 11/27/2022 ALZHEIMERS DISEASE I95.9 HYPOTENSION 11/27/2022 ALZHEIMERS DISEASE J96.00 ACUTE RESPIRATORY FAILURE 11/27/2022 ALZHEIMERS DISEASE
Age: 75.0
Sex: M
Vaccine: HEPA
Symptoms: No adverse event, Product administered to patient of inappropriate age, Underdose
Clinical narrative: No Additional AE; patient received a pediatric dose of VAQTA; patient received a pediatric dose of VAQTA; This spontaneous report was received from a nurse and refers to a 75-year-old male patient. The patient's medical history, concurrent conditions and concomitant medications were not reported.  On 04-APR-2023, the patient was vaccinated with pediatric dose of hepatitis a vaccine, inactivated (VAQTA) intramuscular injection, administered for prophylaxis (anatomical location, lot #, expiry date, and route of administration were not provided) (product administered to patient of inappropriate age, incorrect dose administered). There were no adverse events reported (no adverse event).  This is one of two reports received from the same reporter.
Age: 4.0
Sex: U
Vaccine: MMRV
Symptoms: No adverse event, Product storage error
Clinical narrative: No additional AE/No PQC; PROQUAD was administered to 3 patients after the most recent prior excursion on 4/11/2023 and before the current excursion on 5/4/2023. Date of administration was unknown at time of call.; This spontaneous report was received from the Medical Assistant and refers to a 4-year-old patient of unknown gender.  The patient's medical history, concurrent conditions, and concomitant therapies were not provided.  On an unknown date in 2023, the patient was vaccinated with measles, mumps, rubella and varicella (oka-merck) virus vaccine live (PROQUAD) (recombinant Human albumin) injection, 0.5 milliliter, lot #W012728, expiration date: 16-OCT-2023, administered for prophylaxis (anatomical location, strength, and route of administration were not provided) after the "most recent prior" excursion on 11-APR-2023, and before the current excursion on 04-MAY-2023 (product storage error). No additional adverse events.  The causality between events and suspect therapy was not provided.  This is one of the three reports from the same reporter.; Sender's Comments:  US-009507513-2305USA003457:Merck US-009507513-2305USA003128:Merck
Age: 14.0
Sex: M
Vaccine: HPV9, HPV9, HPV9, HPV9, HPV9
Symptoms: No adverse event, Product storage error
Clinical narrative: Improper storage of product in use; No adverse event; This spontaneous report was received from an office manager referring to a 14-year-old male patient.  The patient's concurrent conditions, medical history, and concomitant therapies were not reported.  On 10-OCT-2022, the patient was vaccinated with one dose of HPV rL1 6 11 16 18 31 33 45 52 58 VLP vaccine (yeast) (GARDASIL 9) pre-filled syringe injection, administered as prophylaxis (there were five possible lot # of the vaccine administered: lot #1775811, expiration date: 07-DEC-2023; lot #1775827, expiration date: 27-JUN-2024; lot #W009829, expiration date: 19-OCT-2024; lot #U032681, expiration date: 26-OCT-2023; and lot #1780876, expiration date: 09-NOV-2023; however, it was not specified which one was received by the patient) (strength, dose, route of administration, anatomical location, and vaccination scheme were not provided). It was reported that the vaccines suffered from three temperature excursions with a total of 25 minutes (on 09-SEP-2022 for 8 minutes; on 16-SEP-2022 for 5 minutes; and on 03-JAN-2023 for 12 minutes). The excursions were not noted until it was noticed that an employee mistakenly cleaned the data logger more than once a day (product storage error). There were no additional adverse events (AEs) reported in the patient (no adverse event).  This is one of several reports received from the same reporter.
Age: 18.0
Sex: F
Vaccine: HPV9
Symptoms: Papilloma viral infection
Clinical narrative: Pharmacist called to report that her patient recently developed HPV at approximately 26-years-old after receiving the full 3-dose series of GARDASIL 9 at 18-years-old.; This spontaneous report was received from a pharmacist and refers to a 26-year-old female patient. No information on patient medical history, current conditions and concomitant medications was provided. On unknown date patient had pap smear and result was HPV positive.      On an unknown dates (when she was 18 years old) the patient was vaccinated with all three doses of hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast) (GARDASIL 9) intramuscularly for human papilloma virus immunization (exact dose, lot# and expiration date were not provided).         On an unknown date the patient experienced papilloma viral infection. The outcome of papilloma viral infection was reported as not recovered. The action taken with hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast) (GARDASIL 9) regarding the event was not applicable.   The causality between the hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast) (GARDASIL 9) and the event papilloma viral infection was not provided.
Sex: U
Vaccine: HEPA
Symptoms: No adverse event, Product storage error
Clinical narrative: No additional AE; improperly stored vaccine; This spontaneous report was received from a medical assistant referring to a patient of unknown age and gender. The patient's medical history, historical drugs, past drug reactions or allergies, concurrent conditions, and concomitant drugs were not reported.   On 03-MAY-2023, the patient was vaccinated with Hepatitis A Vaccine, inactivated (VAQTA) intramuscular injection (0.5 ml/once, lot#: x004813, expiration date: 28-JUL-2024; route of administration, and anatomical location were not reported) for prophylaxis. The vaccine administered was improperly stored at 46.74F for 2 minutes (product storage error). No additional adverse events (AEs) were reported (no adverse event).
Sex: U
Vaccine: VARZOS
Symptoms: Herpes zoster, Sciatica, Vaccination failure
Clinical narrative: because hog a shingles recurrence/It sucks and the vaccine seemed to have reactivated it in me/Suspected vaccination failure; because hog a shingles recurrence/It sucks and the vaccine seemed to have reactivated it in me; deep deep sciatic pain; This serious case was reported by a consumer via interactive digital media and described the occurrence of vaccination failure in a patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   The patient's past medical history included shingles.   On an unknown date, the patient received Shingles vaccine. On an unknown date, an unknown time after receiving Shingles vaccine, the patient experienced vaccination failure (Verbatim: because hog a shingles recurrence/It sucks and the vaccine seemed to have reactivated it in me/Suspected vaccination failure) (serious criteria GSK medically significant), shingles (Verbatim: because hog a shingles recurrence/It sucks and the vaccine seemed to have reactivated it in me) and sciatica (Verbatim: deep deep sciatic pain). The outcome of the vaccination failure was unknown and the outcome of the shingles and sciatica were not reported.   It was unknown if the reporter considered the vaccination failure, shingles and sciatica to be related to Shingles vaccine.     It was unknown if the company considered the vaccination failure, shingles and sciatica to be related to Shingles vaccine.   Additional Information: GSK receipt date: 31-Mar-2023 The case was received from the patient via interactive digital media. The patient stated that unfortunately the shot did not work for everyone, he or she in that 9 percent , dang it. The patient stated that his or her deep deep sciatic pain was off the charts this last month because the shingles recurrence.  Any relief ideas welcome, please. The patient stated that he or she still got them. The patient combined two other vaccines on the same day and his or her immune system might have been overwhelmed. This case was considered as suspected vaccination failure since the details regarding the completion of primary vaccination schedule, time to onset and laboratory confirmation of shingles were unknown at the time of reporting. The follow-up could not be possible as no contact details were available.
Age: 68.0
Sex: F
Vaccine: VARZOS
Symptoms: Herpes zoster, Injection site pain
Clinical narrative: Shingles back of right neck/C5 distribution and left back/T5 distribution; This non-serious case was reported by a consumer via sales rep and described the occurrence of shingles in a 68-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   The patient's past medical history included shingles (Shingles in 40s / original shingles in my 40s, left back -T5 distribution). Previously administered products included Zostavax with an associated reaction of herpes zoster (received about 15 years ago from reporting and got verymild attacks of Shingles every few years in different parts of the body). Concurrent medical conditions included borderline diabetes and hypertension. Concomitant products included metformin and amlodipine (Amlodipin).   On 15-FEB-2023, the patient received the 1st dose of Shingrix. In MAR-2023, 4 weeks after receiving Shingrix, the patient experienced shingles (Verbatim: Shingles back of right neck/C5 distribution and left back/T5 distribution). The outcome of the shingles was resolved.   It was unknown if the reporter considered the shingles to be related to Shingrix.     It was unknown if the company considered the shingles to be related to Shingrix.   Linked case(s) involving the same patient:  US2023AMR071523   Additional Information: GSK Receipt Date: 17-MAY-2023 After the 1st vaccine about 4 weeks later patient got mild Shingles back of right neck C5 distribution and left back T5 distribution. She did not consult with her primary care physician because she knew the diagnosis and did not particularly thought antivirals were necessary. She did realize that generally, Shingrix vaccine was not associated with actually getting the Shingles, but she had afraid she definitely got it with both vaccines. With both vaccines, she did not experience much of other generalized symptoms (pain at the injection site with the second vaccine).  Today (on the day of reporting), she had mentioned to pharmacist about her Shingles episodes after receiving recent Shingrix vaccines as she felt they needed to know. She was just letting GSK know about her experience with Shingrix vaccines just for GSK interest and nothing more. At the end of the day, she was very grateful that Shingrix vaccine was available for all and that hopefully, she would never get Shingles again. The reporter had consented to follow-up. This case had been linked with US2023AMR063356 (for 2nd dose) by same reporter for same patient.
Sex: M
Vaccine: VARZOS
Symptoms: Incomplete course of vaccination
Clinical narrative: 1st dose on 11 Oct 2020 not received 2nd dose yet; This non-serious case was reported by a consumer via call center representative and described the occurrence of incomplete course of vaccination in a male patient who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included Shingrix (1st dose received on 10 November 2020).   On an unknown date, the patient did not receive the 2nd dose of Shingrix. On an unknown date, an unknown time after receiving Shingrix, the patient experienced incomplete course of vaccination (Verbatim: 1st dose on 11 Oct 2020 not received 2nd dose yet). The outcome of the incomplete course of vaccination was unknown.   Additional Information: GSK receipt date: 18-MAY-2023 The reporter enquired could he received the 2nd dose now. Minimal information obtained to file adverse event. Consent not asked. Till the time of reporting, the patient did not receive 2nd dose of Shingrix, which led to incomplete course of vaccination.
Age: 0.75
Sex: F
Vaccine: DTAPIPV
Symptoms: Expired product administered, Product administered to patient of inappropriate age
Clinical narrative: Wrong age; expired dose of Kinrix; This non-serious case was reported by a other health professional via call center representative and described the occurrence of inappropriate age at vaccine administration in a 9-month-old female patient who received DTPa-IPV (Kinrix) (batch number 24T2n, expiry date 07-MAY-2023) for prophylaxis.   On 18-MAY-2023, the patient received the 3rd dose of Kinrix. On 18-MAY-2023, an unknown time after receiving Kinrix, the patient experienced inappropriate age at vaccine administration (Verbatim: Wrong age) and expired vaccine used (Verbatim: expired dose of Kinrix). The outcome of the inappropriate age at vaccine administration and expired vaccine used 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:18-MAY-2023 A medical assistant called in to report that a 9 month old patient was given an expired dose of Kinrix and wished to know how to proceed. Information about the vaccine, patient and event were recorded. The corresponding medical information was read. The Vaccine Administration Facility is the same as Primary Reporter", The reporter consented to follow up. The 9 months old patient was administered with expired vaccine which led to Expired vaccine used and Inappropriate age at vaccine administration.
Age: 79.0
Sex: F
Vaccine: VARZOS
Symptoms: Eye disorder, Sinus headache
Clinical narrative: White lines in the eye; sinus headache; This non-serious case was reported by a consumer via call center representative and described the occurrence of eye abnormality in a 79-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included Zostavax (patient received  Zostavax at the age of 65 years old).   In JAN-2023, the patient received the 1st dose of Shingrix (left arm). On an unknown date, several weeks after receiving Shingrix, the patient experienced eye abnormality (Verbatim: White lines in the eye) and sinus headache (Verbatim: sinus headache). The outcome of the eye abnormality and sinus headache were not resolved.   It was unknown if the reporter considered the eye abnormality and sinus headache to be related to Shingrix.     It was unknown if the company considered the eye abnormality and sinus headache to be related to Shingrix.   Additional Information: GSK Receipt Date: 18-MAY-2023. The patient was self-reported this case. The patient reports that she started having white lines in her eyes.  The patient had folders in eyes (black specks in the eye and these were normal) but these look like white lines.  They were not sharp, they come in for about 5 minutes and goes. It started weeks after the vaccine, and it comes and goes, some last 3 to 4 minutes. The patient reports this never happened before. Patient reports she noticed this happened after getting the Shingrix vaccine and also mentioned during the call that she had a sinus headache. The reporter did not consent to follow-up.
Age: 0.33
Sex: M
Vaccine: DTAPIPV
Symptoms: Product administered to patient of inappropriate age
Clinical narrative: male patient, 4 month old at the time of administration received a dose of Kinrix; This non-serious case was reported by a nurse via call center representative and described the occurrence of inappropriate age at vaccine administration in a 4-month-old male patient who received DTPa-IPV (Kinrix) for prophylaxis.   On 16-JAN-2023, the patient received Kinrix. On 16-JAN-2023, an unknown time after receiving Kinrix, the patient experienced inappropriate age at vaccine administration (Verbatim: male patient, 4 month old at the time of administration received a dose of Kinrix). The outcome of the inappropriate age at vaccine administration was unknown.   This report is made by GSK without prejudice and does not imply any admission or liability for the incident or its consequences.   Additional Information: GSK Receipt Date: 19-MAY-2023 No lot number or expiration date were available. The vaccine administration facility was the same as primary reporter. The reporter consented to follow up.  The 4-month-old patient at the time of administration received a dose of Kinrix, which led to inappropriate age at vaccine administration.
Age: 55.0
Sex: F
Vaccine: VARZOS
Symptoms: Incorrect dose administered, Product preparation issue
Clinical narrative: Maladministration of the AS01B Adjuvant of Shingrix (Without the Lyophilized Antigen Component); Maladministration of the AS01B Adjuvant of Shingrix (Without the Lyophilized Antigen Component); This non-serious case was reported by a other health professional via call center representative and described the occurrence of inappropriate preparation of medication in a 55-year-old female patient who received Herpes zoster (Shingrix) (batch number C495B, expiry date 28-JUN-2024) for prophylaxis.   On 17-MAY-2023, the patient received the 2nd dose of Shingrix. On 17-MAY-2023, an unknown time after receiving Shingrix, the patient experienced inappropriate preparation of medication (Verbatim: Maladministration of the AS01B Adjuvant of Shingrix (Without the Lyophilized Antigen Component)) and inappropriate dose of vaccine administered (Verbatim: Maladministration of the AS01B Adjuvant of Shingrix (Without the Lyophilized Antigen Component)). The outcome of the inappropriate preparation of medication and inappropriate dose of vaccine administered were unknown.   Additional Information: GSK Receipt Date: 19-MAY-2023 The reporter was practice manager. The reporter reported that, a patient received adjuvant Shingrix alone without the powder. The reporter did not consent to follow-up. a patient received adjuvant Shingrix alone without the powder, which led to inappropriate preparation of medication and inappropriate dose of vaccine administered.
Sex: M
Vaccine: VARZOS
Symptoms: Incomplete course of vaccination
Clinical narrative: first dose of Shingrix in 2020 at another unknown pharmacy but then never received the second dose; This non-serious case was reported by a pharmacist via call center representative and described the occurrence of incomplete course of vaccination in a 74-year-old male patient who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included Shingrix (received first dose in 2020 at another pharmacy).   On an unknown date, the patient did not receive the 2nd dose of Shingrix. On an unknown date, an unknown time after receiving Shingrix, the patient experienced incomplete course of vaccination (Verbatim: first dose of Shingrix in 2020 at another unknown pharmacy but then never received the second dose). The outcome of the incomplete course of vaccination was unknown.   Additional Information: GSK receipt date: 19-May-2023 The reporter stated that the consumer stated he would follow-up with his doctor of medicine (MD) for medical guidance prior to making a decision about if and when to get the second dose. Did not consent to follow-up. Till the time of reporting, the patient did not receive the second dose of Shingrix, which led to incomplete course of vaccination.
Sex: F
Vaccine: VARZOS
Symptoms: Incomplete course of vaccination
Clinical narrative: she did not get the second dose of SHINGRIX yet; This non-serious case was reported by a consumer via call center representative and described the occurrence of incomplete course of vaccination in a female patient who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included Shingrix (1st dose received in 2021).   On an unknown date, the patient did not receive the 2nd dose of Shingrix. On an unknown date, an unknown time after receiving Shingrix, the patient experienced incomplete course of vaccination (Verbatim: she did not get the second dose of SHINGRIX yet). The outcome of the incomplete course of vaccination was unknown.   Additional Information: GSK receipt date: 19-MAY-2023 The pharmacist reported that a patient reported that she did not get the second dose of Shingrix yet. Education provided per content. The reporter did not consent to follow-up. Till the time of reporting, the patient did not receive 2nd dose of Shingrix, which led to incomplete course of vaccination.
Age: 35.0
Sex: M
Vaccine: VARZOS
Symptoms: Product administered to patient of inappropriate age
Clinical narrative: Administration to patient under 50; This non-serious case was reported by a nurse via call center representative and described the occurrence of inappropriate age at vaccine administration in a 35-year-old male patient who received Herpes zoster (Shingrix) (batch number 4RP9E, expiry date 07-JUL-2024) for prophylaxis.   On 16-MAY-2023, the patient received the 1st dose of Shingrix. On 16-MAY-2023, an unknown time after receiving Shingrix, the patient experienced inappropriate age at vaccine administration (Verbatim: Administration to patient under 50). The outcome of the inappropriate age at vaccine administration was unknown.   Additional Information: GSK receipt date: 19-MAY-2023 A registered nurse reported that a patient under the age of 50 was administered the first dose of Shingrix and wished to know how to proceed.  Information about the vaccine, patient and vaccination was provided. The vaccine administration facility was the same as primary reporter. The reporter consented to follow up.  The patient with under age of 50 was administered Shingrix vaccine, which led to inappropriate age at vaccine administration.