chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 68.0
Sex: F
Vaccine: COVID19-2
Symptoms: Arthralgia, Hypertension, Malaise, Myalgia, Pain in extremity
Clinical narrative: Per vaccine recipient, "I got sick last night after getting the COVID shot that I got yesterday morning. I had a fever of 102, my blood pressure was really high, 175/100, my muscles and joints hurt, and it was really weird, the bottoms of my feet felt like I was walking on broken glass. They felt really hot too. I soaked them in cold water and that helped some, but they feel hot again now. My blood pressure has come down some too, but it's still 149/90 this morning (the day after receiving the vaccine)."
Age: 68.0
Sex: F
Vaccine: COVID19-2
Symptoms: Pyrexia, Skin warm
Clinical narrative: Per vaccine recipient, "I got sick last night after getting the COVID shot that I got yesterday morning. I had a fever of 102, my blood pressure was really high, 175/100, my muscles and joints hurt, and it was really weird, the bottoms of my feet felt like I was walking on broken glass. They felt really hot too. I soaked them in cold water and that helped some, but they feel hot again now. My blood pressure has come down some too, but it's still 149/90 this morning (the day after receiving the vaccine)."
Age: 0.83
Sex: F
Vaccine: COVID19
Symptoms: No adverse event, Product preparation error
Clinical narrative: COVID vaccine was diluted with the incorrect dosage. Dilution was 0.2 mls instead of 2.2 mls. MOP was notified and no side effects were reported.
Age: 56.0
Sex: F
Vaccine: COVID19
Symptoms: Anxiety, No adverse event
Clinical narrative: I did not have an adverse reaction with the vaccine. I had an appointment with my general doctor and was referred to a therapist. I was diagnosed with anxiety and currently under treatment.
Age: 1.25
Sex: F
Vaccine: COVID19-2, DTAPIPVHIB
Symptoms: COVID-19, Cough, Irritability, Pyrexia, SARS-CoV-2 test positive
Clinical narrative: 6/17/23 during the night she woke up with a strider cough and was wheezing. She had a low grade fever off and on and was a little grumpy. On 6/18/23 she tested positive with an at home COVID test. She was given an oral steroid at the urgent care. She had some MOTRIN because she was a little grumpy.
Age: 1.25
Sex: F
Vaccine: COVID19-2, DTAPIPVHIB
Symptoms: Stridor, Wheezing
Clinical narrative: 6/17/23 during the night she woke up with a strider cough and was wheezing. She had a low grade fever off and on and was a little grumpy. On 6/18/23 she tested positive with an at home COVID test. She was given an oral steroid at the urgent care. She had some MOTRIN because she was a little grumpy.
Age: 53.0
Sex: F
Vaccine: COVID19
Symptoms: Acute myocardial infarction
Clinical narrative: ACUTE NON ST ELEVATION MI
Age: 46.0
Sex: M
Vaccine: COVID19
Symptoms: Focal dyscognitive seizures, Partial seizures
Clinical narrative: PARTIAL EPILEPSY COMPLEX PARTIAL EPILEPSY
Age: 65.0
Sex: F
Vaccine: COVID19
Symptoms: Cardiac disorder, Cardiac dysfunction, Cardiac output decreased, Fatigue, Laboratory test
Clinical narrative: outcome is heart only puts out 30 % and now very ill.  ever since shot been sick
Age: 65.0
Sex: F
Vaccine: COVID19
Symptoms: Malaise
Clinical narrative: outcome is heart only puts out 30 % and now very ill.  ever since shot been sick
Age: 62.0
Sex: F
Vaccine: COVID19
Symptoms: Cardiac failure congestive, Pulmonary embolism
Clinical narrative: I26.99 ACUTE PULMONARY EMBOLISM 5/1/2023 CHF (CONGESTIVE HEART FAILURE), UNSPECIFIED I26.99 ACUTE PULMONARY EMBOLISM 5/1/2023 ACUTE PULMONARY EMBOLISM
Age: 35.0
Sex: M
Vaccine: COVID19
Symptoms: Epilepsy
Clinical narrative: EPILEPSY, UNSPECIFIED
Age: 80.0
Sex: F
Vaccine: COVID19
Symptoms: Acute respiratory failure, Hyperlipidaemia, Respiratory failure, Type 2 diabetes mellitus
Clinical narrative: J96.21 ACUTE ON CHRONIC HYPOXEMIC RESPIRATORY FAILURE 3/21/2023 DM 2 W HYPERLIPIDEMIA
Age: 82.0
Sex: F
Vaccine: COVID19
Symptoms: Pulmonary embolism
Clinical narrative: ACUTE PULMONARY EMBOLISM
Age: 69.0
Sex: M
Vaccine: COVID19
Symptoms: Acute myocardial infarction
Clinical narrative: I21.19 ACUTE ST ELEVATION MI, INFERIOR WALL 4/4/2023 ACUTE ST ELEVATION MI, INFERIOR WALL
Age: 3.0
Sex: F
Vaccine: COVID19-2
Symptoms: COVID-19, Cough, Exposure to SARS-CoV-2, SARS-CoV-2 test positive, Wheezing
Clinical narrative: Family caught COVID-19 starting last week, she woke up coughing wheezing and congested 18JUN2023 nebulizer was given to open airways and on 19JUN2023 COVID-19 Test-Positve resulted.  Sympytoms resolved within twentyfour  hours.
Age: 71.0
Sex: M
Vaccine: COVID19
Symptoms: Hypotension
Clinical narrative: HYPOTENSION
Age: 0.17
Sex: F
Vaccine: DTPPVHBHPB, PNC15, RV1, DTPPVHBHPB, PNC15, RVX
Symptoms: Crying, Dyskinesia
Clinical narrative: Crying Involuntary movement
Age: 73.0
Sex: M
Vaccine: COVID19
Symptoms: Musculoskeletal stiffness, Neck pain, Pain, Pain in extremity
Clinical narrative: right arm pain/stiffness radiating to neck
Age: 42.0
Sex: M
Vaccine: COVID19
Symptoms: Pulmonary embolism
Clinical narrative: ACUTE PULMONARY EMBOLISM
Age: 25.0
Sex: F
Vaccine: HEP
Symptoms: Incorrect dose administered, Product administered to patient of inappropriate age
Clinical narrative: Pediatric dose given
Age: 11.0
Sex: M
Vaccine: HEPA, HPV9, MNQ, TDAP, VARCEL
Symptoms: Product preparation error
Clinical narrative: The staff member administered the diluent only for the varicella vaccine. The staff noted this after administration, notified the provider, the provider explained to the patient/parents, and the varicella vaccine was then correctly administered.
Age: 57.0
Sex: F
Vaccine: COVID19
Symptoms: Angiogram cerebral, Computerised tomogram head, Computerised tomogram neck, Hypoglossal nerve disorder, Laboratory test
Clinical narrative: Stabbing pains in throat started within a week of vaccine.  Turned into excruciating pain in Feb 2023.  Now diagnosed with Hypoglossal neuralgia. Possible underlying causes of MS, Lou Gherig's, brain aneurysm and brain tumor have all been ruled out.
Age: 57.0
Sex: F
Vaccine: COVID19
Symptoms: Laryngoscopy, Magnetic resonance imaging head, Magnetic resonance imaging spinal, Neuralgia, Oropharyngeal pain
Clinical narrative: Stabbing pains in throat started within a week of vaccine.  Turned into excruciating pain in Feb 2023.  Now diagnosed with Hypoglossal neuralgia. Possible underlying causes of MS, Lou Gherig's, brain aneurysm and brain tumor have all been ruled out.
Age: 57.0
Sex: F
Vaccine: COVID19
Symptoms: Scan with contrast, X-ray
Clinical narrative: Stabbing pains in throat started within a week of vaccine.  Turned into excruciating pain in Feb 2023.  Now diagnosed with Hypoglossal neuralgia. Possible underlying causes of MS, Lou Gherig's, brain aneurysm and brain tumor have all been ruled out.
Age: 61.0
Sex: M
Vaccine: COVID19
Symptoms: Acute respiratory failure, Pulmonary embolism
Clinical narrative: ACUTE RESPIRATORY FAILURE ACUTE PULMONARY EMBOLISM
Age: 86.0
Sex: F
Vaccine: COVID19
Symptoms: Unevaluable event
Clinical narrative: PATIENT RECEIVED VACCINE FROM OUTSIDE SOURCE
Age: 1.75
Sex: F
Vaccine: COVID19-2
Symptoms: Unevaluable event
Clinical narrative: Pt received Moderna bivalent 0.25ml of the 50mcg/0.5ml bottle. Pt had 2 doses of Moderna monovalent vaccines previously.
Age: 69.0
Sex: F
Vaccine: VARZOS
Symptoms: Chills, Injection site erythema, Injection site swelling, Injection site warmth
Clinical narrative: The area around the injection site is red, slightly warm to the touch and slightly raised. It is about 2 inches in diameter. She also said she felt "some chills" last night (6/20/23), but did not have them at the time I spoke to her (6/21/23) I told her to take some ibuprofen tonight, and if it has not improved by 6/22/23 to contact her doctor.
Age: 25.0
Sex: M
Vaccine: COVID19
Symptoms: Alcohol use, Cardiac failure, Cardiomyopathy, Dyspnoea, Echocardiogram abnormal
Clinical narrative: The night of the vaccination I had severe flu-like symptoms like sweating, aches,  and nausea. These went away after a day. Over the months following my vaccination, I experienced increasing palpitations and I eventually had a handful of SVT's that sent me to the ER. One morning, after having consumed alcohol the night before, I had a racing heart and shortness of breath and took a breath from an inhaler and went tachycardic. The ER doctors thought that nothing was wrong with me. After testing I was found to have developed heart failure seemingly inexplicably. Two years later I am much better after taking beta blockers but I am still recovering and I will be dealing with this illness for the foreseeable future.
Age: 25.0
Sex: M
Vaccine: COVID19
Symptoms: Ejection fraction decreased, Electrocardiogram ambulatory normal, Hyperhidrosis, Influenza like illness, Laboratory test normal
Clinical narrative: The night of the vaccination I had severe flu-like symptoms like sweating, aches,  and nausea. These went away after a day. Over the months following my vaccination, I experienced increasing palpitations and I eventually had a handful of SVT's that sent me to the ER. One morning, after having consumed alcohol the night before, I had a racing heart and shortness of breath and took a breath from an inhaler and went tachycardic. The ER doctors thought that nothing was wrong with me. After testing I was found to have developed heart failure seemingly inexplicably. Two years later I am much better after taking beta blockers but I am still recovering and I will be dealing with this illness for the foreseeable future.
Age: 25.0
Sex: M
Vaccine: COVID19
Symptoms: Left ventricular dilatation, Multiple gated acquisition scan abnormal, Nausea, Pain, Palpitations
Clinical narrative: The night of the vaccination I had severe flu-like symptoms like sweating, aches,  and nausea. These went away after a day. Over the months following my vaccination, I experienced increasing palpitations and I eventually had a handful of SVT's that sent me to the ER. One morning, after having consumed alcohol the night before, I had a racing heart and shortness of breath and took a breath from an inhaler and went tachycardic. The ER doctors thought that nothing was wrong with me. After testing I was found to have developed heart failure seemingly inexplicably. Two years later I am much better after taking beta blockers but I am still recovering and I will be dealing with this illness for the foreseeable future.
Age: 25.0
Sex: M
Vaccine: COVID19
Symptoms: Supraventricular tachycardia, Tachycardia
Clinical narrative: The night of the vaccination I had severe flu-like symptoms like sweating, aches,  and nausea. These went away after a day. Over the months following my vaccination, I experienced increasing palpitations and I eventually had a handful of SVT's that sent me to the ER. One morning, after having consumed alcohol the night before, I had a racing heart and shortness of breath and took a breath from an inhaler and went tachycardic. The ER doctors thought that nothing was wrong with me. After testing I was found to have developed heart failure seemingly inexplicably. Two years later I am much better after taking beta blockers but I am still recovering and I will be dealing with this illness for the foreseeable future.
Age: 84.0
Sex: F
Vaccine: VARZOS
Symptoms: Rash, Rash pruritic
Clinical narrative: PT HAS A RASH ON HER BACK THAT KEEPS COMING AND GOING AND IS VERY ITCHY.  IT STARTED RIGHT AFTER 2ND DOSE OF SHINGRIX. MD IS TREATING WITH TRIAMCINOLONE
Age: 16.0
Sex: F
Vaccine: UNK
Symptoms: Asthenia, Back pain, Dizziness, Hypersensitivity, Nausea
Clinical narrative: On 6/20/23, a 16 years old female presented to the ED with moderate allergic symptoms after receiving a meningitis and tetanus vaccine characterized as nausea, dizziness, blurry vision, generalized weakness, and back pain. After treatment in the emergency department, the patient?s symptoms much improved and they are feeling well, breathing well, and without complaint.
Age: 16.0
Sex: F
Vaccine: UNK
Symptoms: Vision blurred
Clinical narrative: On 6/20/23, a 16 years old female presented to the ED with moderate allergic symptoms after receiving a meningitis and tetanus vaccine characterized as nausea, dizziness, blurry vision, generalized weakness, and back pain. After treatment in the emergency department, the patient?s symptoms much improved and they are feeling well, breathing well, and without complaint.
Age: 1.0
Sex: M
Vaccine: COVID19-2
Symptoms: Expired product administered
Clinical narrative: Expired dose given
Age: 1.92
Sex: M
Vaccine: COVID19-2
Symptoms: Expired product administered
Clinical narrative: Expired vaccine administered
Age: 65.0
Sex: F
Vaccine: PNC20
Symptoms: Headache, Rash, Rash erythematous, Rash macular, Rash pruritic
Clinical narrative: Per Patient "Last evening I developed a mild rash, mostly on my arms and torso. Pink, splotchy and itchy.  Also a headache. I called the nurse advisor to discuss.  Because I was scheduled for a bone density this morning I didn't take any benedryl as it contains calcium, but used topical Cortisone 10.  This morning the rash as almost entirely gone.  The nurse advisor suggested that I advise you since it was possibly a reaction to the pneumonia shot.  I had eaten shrimp for dinner but have never had any reactions to shellfish in the past.  Nurse advisor couldn't find any connection between the vaccine and shellfish. I still have a mild headache but otherwise okay."
Age: 6.0
Sex: F
Vaccine: COVID19-2
Symptoms: Expired product administered
Clinical narrative: The Covid vaccine EXP date as per the labels on the immunization box is 01/31/2024, but the BUD Expiration date from the Pharmacy is 06/07/2023.  The vaccine was given pass the BUD Expiration date.
Age: 50.0
Sex: F
Vaccine: VARZOS
Symptoms: Balance disorder, Dizziness, Fall
Clinical narrative: Dizziness lead to loss of balance and patient fell on the floor after setting up appointment for 2nd dose. She was ok. She stayed on the ground to recover. No additional injury was reported.  She left with her family member once she recovered
Age: 10.0
Sex: F
Vaccine: COVID19-2, HEPA, MNQ
Symptoms: Incorrect dose administered
Clinical narrative: Received Pfizer Bivalen 12+ rather than Pfizer Bivalent 6-11yr
Age: 69.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: COVID-19, Cough, Death, Dyspnoea, Respiratory failure
Clinical narrative: This patient presented to hospital with increased dyspnea and cough. She tested positive for COVID after contracting it from her family. She has been hospitalized with high O2 requirements. She was treated with dexamethasone and had few complications beyond respiratory failure. She transfers for ongoing high O2 requirements. The patient reports ongoing cough, congestion, and dyspnea. The patient continued to require high amounts of 02- 100%/40L Vapotherm and NRB without ability to wean. For several days, the patient expressed that she is ready for transition to comfort care but is "waiting on sign from God" to know when to turn off the Oxygen. The family and patient decided to transition to comfort care. The patient was pronounced deceased at 1446 on 6/17/2023 with family at bedside.
Age: 69.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Respiratory tract congestion, SARS-CoV-2 test positive, Weaning failure
Clinical narrative: This patient presented to hospital with increased dyspnea and cough. She tested positive for COVID after contracting it from her family. She has been hospitalized with high O2 requirements. She was treated with dexamethasone and had few complications beyond respiratory failure. She transfers for ongoing high O2 requirements. The patient reports ongoing cough, congestion, and dyspnea. The patient continued to require high amounts of 02- 100%/40L Vapotherm and NRB without ability to wean. For several days, the patient expressed that she is ready for transition to comfort care but is "waiting on sign from God" to know when to turn off the Oxygen. The family and patient decided to transition to comfort care. The patient was pronounced deceased at 1446 on 6/17/2023 with family at bedside.
Age: 69.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Breakthrough COVID-19
Clinical narrative: This patient presented to hospital with increased dyspnea and cough. She tested positive for COVID after contracting it from her family. She has been hospitalized with high O2 requirements. She was treated with dexamethasone and had few complications beyond respiratory failure. She transfers for ongoing high O2 requirements. The patient reports ongoing cough, congestion, and dyspnea. The patient continued to require high amounts of 02- 100%/40L Vapotherm and NRB without ability to wean. For several days, the patient expressed that she is ready for transition to comfort care but is "waiting on sign from God" to know when to turn off the Oxygen. The family and patient decided to transition to comfort care. The patient was pronounced deceased at 1446 on 6/17/2023 with family at bedside.
Age: 89.0
Sex: F
Vaccine: VARZOS
Symptoms: Blood test normal, Computerised tomogram normal, Decreased appetite, Discomfort, Fatigue
Clinical narrative: Patient stated arm sore at 5:00pm day of vaccination.  Pain increased and was excruciating by 8:00pm same day. Tylenol and ice pack did not alleviate discomfort.  Patient did not eat dinner that evening due to nausea and overall malaise.  Patient experienced restless sleep due to nausea and pain. During following 2 weeks, patient lost appetite and was forcing herself to take in nourishment.  At end of 2 weeks, patient had lost 5 lbs and the nausea lingered, although the soreness and general malaise had subsided.   Patient's condition slowly improved but never recovered to feeling as before the vaccination.  Patient followed up with her physician and blood tests showed no abnormalities.  May 2, 2023 the patient was admitted in the hospital after visiting the ER with symptoms exactly as after the vaccination.  All tests (CT, ultrasound, blood test) came back normal and patient was discharged on May 4, 2023.   Patient followed up with her GI specialist who stated this may be lingering effect from vaccination.  Patient continued to feel tired and "not herself".  Patient states as of June 1, 2023 that all symptoms are improving.  Patient attributes her condition to the vaccination.
Age: 89.0
Sex: F
Vaccine: VARZOS
Symptoms: Feeling abnormal, Malaise, Nausea, Pain, Pain in extremity
Clinical narrative: Patient stated arm sore at 5:00pm day of vaccination.  Pain increased and was excruciating by 8:00pm same day. Tylenol and ice pack did not alleviate discomfort.  Patient did not eat dinner that evening due to nausea and overall malaise.  Patient experienced restless sleep due to nausea and pain. During following 2 weeks, patient lost appetite and was forcing herself to take in nourishment.  At end of 2 weeks, patient had lost 5 lbs and the nausea lingered, although the soreness and general malaise had subsided.   Patient's condition slowly improved but never recovered to feeling as before the vaccination.  Patient followed up with her physician and blood tests showed no abnormalities.  May 2, 2023 the patient was admitted in the hospital after visiting the ER with symptoms exactly as after the vaccination.  All tests (CT, ultrasound, blood test) came back normal and patient was discharged on May 4, 2023.   Patient followed up with her GI specialist who stated this may be lingering effect from vaccination.  Patient continued to feel tired and "not herself".  Patient states as of June 1, 2023 that all symptoms are improving.  Patient attributes her condition to the vaccination.
Age: 89.0
Sex: F
Vaccine: VARZOS
Symptoms: Poor quality sleep, Ultrasound scan normal, Weight decreased
Clinical narrative: Patient stated arm sore at 5:00pm day of vaccination.  Pain increased and was excruciating by 8:00pm same day. Tylenol and ice pack did not alleviate discomfort.  Patient did not eat dinner that evening due to nausea and overall malaise.  Patient experienced restless sleep due to nausea and pain. During following 2 weeks, patient lost appetite and was forcing herself to take in nourishment.  At end of 2 weeks, patient had lost 5 lbs and the nausea lingered, although the soreness and general malaise had subsided.   Patient's condition slowly improved but never recovered to feeling as before the vaccination.  Patient followed up with her physician and blood tests showed no abnormalities.  May 2, 2023 the patient was admitted in the hospital after visiting the ER with symptoms exactly as after the vaccination.  All tests (CT, ultrasound, blood test) came back normal and patient was discharged on May 4, 2023.   Patient followed up with her GI specialist who stated this may be lingering effect from vaccination.  Patient continued to feel tired and "not herself".  Patient states as of June 1, 2023 that all symptoms are improving.  Patient attributes her condition to the vaccination.
Age: 80.0
Sex: M
Vaccine: COVID19-2
Symptoms: Death, Positive airway pressure therapy, Respiratory distress
Clinical narrative: This patient presented to hospital as a transfer where he has been hospitalized for the last week. He was admitted with complaints of respiratory distress. The patient is on home oxygen with 10 L of O2. He also has a home trilogy machine. Following his admission he continued to require high amounts of oxygen. He was on 100%/ 40L with a NRB as needed and then progressed to requiring Bipap most of the day and night. The patient was a DNR and the family was discussing end of life care with hospice. The patient was pronounced deceased at 1029 on 6/20/2023 with family at bedside.
Age: 65.0
Sex: F
Vaccine: COVID19-2
Symptoms: Auditory disorder, Bronchitis, Cough, Ear infection, Malaise
Clinical narrative: In April of 2023, I had a cold and on day 4 I had a sinus infection and ear infection and then it moved into my lungs.  I didn't really feel 100% for over a month.  I went to urgent care on April 3, 2023.  I was prescribed antibiotics for 7-10 days.  My symptoms got better but not completely better.  In May, I had symptoms again for my sinuses and then my lungs were affected.  I was tested for pneumonia with an X-Ray and it was negative.  As of today I feel like my ears are still messed up because my hearing is not right.  I also had a cough that took a few weeks to go away because of mucus that I was unable to cough up.
Age: 65.0
Sex: F
Vaccine: COVID19-2
Symptoms: Nasopharyngitis, Pneumonia, Respiratory symptom, SARS-CoV-2 test negative, Secretion discharge
Clinical narrative: In April of 2023, I had a cold and on day 4 I had a sinus infection and ear infection and then it moved into my lungs.  I didn't really feel 100% for over a month.  I went to urgent care on April 3, 2023.  I was prescribed antibiotics for 7-10 days.  My symptoms got better but not completely better.  In May, I had symptoms again for my sinuses and then my lungs were affected.  I was tested for pneumonia with an X-Ray and it was negative.  As of today I feel like my ears are still messed up because my hearing is not right.  I also had a cough that took a few weeks to go away because of mucus that I was unable to cough up.
Age: 65.0
Sex: F
Vaccine: COVID19-2
Symptoms: Sinus disorder, Sinusitis, X-ray abnormal
Clinical narrative: In April of 2023, I had a cold and on day 4 I had a sinus infection and ear infection and then it moved into my lungs.  I didn't really feel 100% for over a month.  I went to urgent care on April 3, 2023.  I was prescribed antibiotics for 7-10 days.  My symptoms got better but not completely better.  In May, I had symptoms again for my sinuses and then my lungs were affected.  I was tested for pneumonia with an X-Ray and it was negative.  As of today I feel like my ears are still messed up because my hearing is not right.  I also had a cough that took a few weeks to go away because of mucus that I was unable to cough up.
Sex: F
Vaccine: HEP
Symptoms: Extra dose administered, Inappropriate schedule of product administration
Clinical narrative: hep-B: 20-JAN-2004, 22-MAR-2004, 11-APR-2005, 18-OCT-2005; hep-B: 22-MAR-2004, 11-APR-2005; hep-B: 20-JAN-2004, 22-MAR-2004; This spontaneous report has been received from a licensed practical nurse, via medical records from a case in litigation for quadrivalent human papillomavirus (types 6,11,16,18) recomb. vaccine (GARDASIL) (MARRS # 2303USA000170), concerning an 8-week-month old, female patient. The patient's medical history, concurrent conditions and concomitant therapies prior to vaccinations were not reported.  On 20-JAN-2004, the patient was vaccinated with the first dose of hepatitis b vaccine (recombinant) (manufacturer unknown) (exact dose, strength, lot #, expiration date, site and route of administration were not provided) for prophylaxis. On 22-MAR-2004, the patient was vaccinated with the second dose of hepatitis b vaccine (recombinant) (manufacturer unknown) (exact dose, strength, lot #, expiration date, site and route of administration were not provided) for prophylaxis (inappropriate schedule of product administered). On 11-APR-2005, the patient was vaccinated with the third dose of hepatitis b vaccine (recombinant) (manufacturer unknown) (exact dose, strength, lot #, expiration date, site and route of administration were not provided) for prophylaxis (inappropriate schedule of product administered). On 18-OCT-2005, the patient was vaccinated with the fourth dose of hepatitis b vaccine (recombinant) (manufacturer unknown) (exact dose, strength, lot #, expiration date, site and route of administration were not provided) for prophylaxis (extra dose administered).  This is one of several reports regarding the same patient.  All available medical records will be provided upon request.; Sender's Comments:  US-009507513-2303USA000170:Original Case 2303USA000170 US-009507513-2306USA000601:Split 2306USA000601 US-009507513-2306USA000600:Split 2306USA000600
Sex: U
Vaccine: VARCEL
Symptoms: Expired product administered, Product storage error
Clinical narrative: Temperature excursion; No further AE details; HCP called to report an expired dose of VARIVAX was administered to Multiple patients. Patient Demographics provided for all patients, please see notes for additional case numbers. HCP gave permission to contact. No symptoms reported. No further AE d; This spontaneous report was received from Pharmacist and refers to a 22-month-old patient of unknown gender.  The patient's medical history was not reported. The patient's concurrent conditions were not reported. Concomitant therapies were not reported.  On 08-JUN-2023, the patient started therapy with varicella virus vaccine live (oka/merck) (VARIVAX) injection, 0.5ml/once, administered for prophylaxis (strength, lot #, expiry date, and route of administration were not provided).  On 02-MAR-2023, there was excursion temperature (70 F) for 9 minutes. On 08-JUN-2023, the patient experienced HCP called to report an expired dose of VARIVAX was administered to Multiple patients. Patient Demographics provided for all patients, please see notes for additional case numbers. HCP gave permission to contact. No symptoms reported. No further AE details/No PQC.   Lot Number W0252273 is NOT valid for V210 and does not match any Company product.; Sender's Comments:  US-009507513-2306USA007905: US-009507513-2306USA007917: US-009507513-2306USA008590: US-009507513-2306USA008606: US-009507513-2306USA008760: US-009507513-2306USA008746: US-009507513-2306USA008802: US-009507513-2306USA008772: US-009507513-2306USA008793:
Sex: U
Vaccine: VARCEL
Symptoms: Expired product administered, No adverse event
Clinical narrative: Temperature excursion; No further AE details; HCP called to report an expired dose of VARIVAX was administered to Multiple patients. Patient Demographics provided for all patients, please see notes for additional case numbers. HCP gave permission to contact. No symptoms reported. No further AE d; This spontaneous report was received from Pharmacist and refers to a 15-month-old patient of unknown gender.  The patient's medical history was not reported. The patient's concurrent conditions were not reported. Concomitant therapies were not reported.  On an unknown date, the patient started therapy with varicella virus vaccine live (oka/merck) (VARIVAX) injection, 0.5ml/once, administered for prophylaxis (strength, lot #, expiry date, and route of administration were not provided).  On 07-JUN-2023, HCP called to report an expired dose of VARIVAX was administered to Multiple patients. Patient Demographics provided for all patients, please see notes for additional case numbers. HCP gave permission to contact. No symptoms reported. No further AE details/No PQC.  Lot Number W0252273 is NOT valid for V210 and does not match any Company product.
Age: 11.0
Sex: U
Vaccine: VARCEL
Symptoms: Expired product administered, No adverse event, Product storage error
Clinical narrative: No further AE details; HCP called to report an expired dose of VARIVAX was administered; Product storage error; This spontaneous report was received from a pharmacist and refers to an 11-year-old patient of unknown gender.  The patient's medical history, concurrent conditions and concomitant therapies were not reported.  On 02-MAR-2023, varicella virus vaccine live (oka/merck) (VARIVAX) underwent temperature excursion for 9 minutes in 70 Fahrenheit (F) (Product storage error). On 08-JUN-2023, the patient was vaccinated with expired dose of varicella virus vaccine live (oka/merck) (VARIVAX) injection, 0.5 milliliter, administered for prophylaxis (strength, lot #, expiry date, and route of administration were not provided) (Expired product administered). No additional events were reported.  Lot number #W0252273 has been verified to be a non valid number for varicella virus vaccine live (oka/merck).; Sender's Comments:  US-009507513-2306USA007917: US-009507513-2306USA007830: US-009507513-2306USA007844: US-009507513-2306USA007881:
Sex: M
Vaccine: HEP
Symptoms: Inappropriate schedule of product administration
Clinical narrative: first dosage of HEPB on 17-SEP-2002 and second dosage of HEPB on 18-NOV-2002; This spontaneous report has been received from a physician, via medical records (immunization record) from a case in litigation for HPV rL1 6 11 16 18 31 33 45 52 58 VLP vaccine (yeast) (GARDASIL 9) (MARRS # 2303USA000135), concerning a 8-week-old male patient (pt). Concomitant vaccinations included diphtheria vaccine toxoid (+) pertussis vaccine acellular 3-component (+) tetanus vaccine toxoid (INFANRIX), polio vaccine inact (IPV), hib vaccine (HIB) and pneumococcal vaccine conj 7v (crm197) (PREVNAR). Information about concurrent condition and medical history was not reported.   On 17-SEP-2002, 18-NOV-2002 and 19-MAR-2003, the pt was vaccinated with 3 doses of hepatitis b vaccine (recombinant) (manufacturer unknown) (reported as hepatitis B vaccine PED/ADOL) (0.5 ml; strength, lot # and expiration date were not provided) intramuscularly for prophylaxis, respectively (inappropriate schedule of product administration for dose 2 on 18-NOV-2002).   This is one of several reports for the same pt.; Sender's Comments:  US-009507513-2303USA000135: US-009507513-2306USA008274:
Age: 9.0
Sex: M
Vaccine: HEPA
Symptoms: Inappropriate schedule of product administration
Clinical narrative: first dosage of HEPA on 01-FEB-2012, second dosage of HEPA on 01-APR-2014; This spontaneous report has been received from a physician, via medical records (immunization record) from a case in litigation for HPV rL1 6 11 16 18 31 33 45 52 58 VLP vaccine (yeast) (GARDASIL 9) (MARRS # 2303USA000135), concerning a 11-year-old male patient (pt). Concomitant vaccinations included diphtheria vaccine toxoid (+) pertussis vaccine acellular 5-component (+) tetanus vaccine toxoid (ADACEL) and meningococcal MCV40 (CVX 136). Information about concurrent condition and medical history was not reported.   On 01-FEB-2012 and 01-APR-2014, the pt was vaccinated with 2 doses of hepatitis a vaccine, inactivated (manufacturer unknown) (reported as hepatitis A vaccine PED/ADOL) (strength, exact dose, route,  lot # and expiration date were not provided) for prophylaxis, respectively (inappropriate schedule of product administration).   This is one of several reports for the same pt.; Sender's Comments:  US-009507513-2306USA008273: US-009507513-2303USA000135:
Age: 15.0
Sex: U
Vaccine: VARCEL
Symptoms: Expired product administered, No adverse event, Product storage error
Clinical narrative: No symptoms reported; HCP called to report an expired dose of VARIVAX was administered to Multiple patients.; Date of excursion: 3/2/2023; This spontaneous report was received from a pharmacist referring to 15-year-old patient of unknown gender. Information about the patient's pertinent medical history, concurrent conditions, concomitant medications and drug reactions/allergies was not provided.  On 12-JUN-2023, the patient was vaccinated with improperly stored and expired dose of varicella virus vaccine live (Oka/Merck) (VARIVAX) injection (0.5 mL, lot #W0252273 was established as not valid, expiration date was reported as 02-JUN-2023, route of administration and anatomical location were not provided) for prophylaxis (Expired vaccine used, Improper storage of product in use).  On 02-MAR-2023, the suspect vaccine experienced a temperature excursion of 70 degrees Fahrenheit for 9 minutes. No symptoms reported (No adverse event). No further adverse event (AE) details. No product quality complaint (PQC).  This is one of multiple reports from the same reporter.
Sex: U
Vaccine: HPV9
Symptoms: Accidental overdose, No adverse event
Clinical narrative: No adverse event; received 2 same doses of the GARDASIL 9 vaccine back-to-back.; This spontaneous report was received from an consumer and refers to a patient of unknown age and gender.  The patient's medical history, concurrent conditions and concomitant therapies were not reported.  On 16-JUN-2023, the patient was vaccinated with two doses of hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast) (GARDASIL 9) injection, 1 dose, lot #W026977, expiration date: 04-JAN-2025, administered for prophylaxis (strength, and route of administration were not provided). The patient had received 2 same doses of hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast) (GARDASIL 9) vaccine back-to-back (Accidental overdose). Patient had not experienced any side effects. No additional adverse event were reported.
Age: 16.0
Sex: U
Vaccine: VARCEL, VARCEL
Symptoms: Expired product administered, Product storage error
Clinical narrative: HCP called to report an expired dose of VARIVAX was administered to Multiple patients. Patient Demographics provided for all patients, please see notes for additional case numbers. HCP gave permission to contact. No symptoms reported. No further AE d; HCP called to report an expired dose of VARIVAX was administered to Multiple patients. Patient Demographics provided for all patients, please see notes for additional case numbers. HCP gave permission to contact. No symptoms reported. No further AE d; This spontaneous report was received from pharmacist and refers to a 16-year-old. Information regarding the patient's concurrent conditions, medical history, or concomitant medications was not provided.  On 12-JUN-2023, the patient was vaccinated with an improperly stored dose of measles, mumps, rubella and varicella virus vaccine live (oka/merck) (VARIVAX) administered for prophylaxis (formulation, route of administration, vaccination scheme frequency, and anatomical location were not provided; lot number WO252273 with expiration date of 02-JUN-2023 but upon internal validation established as W0252273 with an expiry date of 10-AUG-2024 (conflicting information as it was reported that the product was expired)). The administered dose of the vaccine experienced a temperature excursion of 70 degrees Fahrenheit for 9 minutes on 02-MAR-2023. It was not reported if the information was obtained from the data logger or not. There was no adverse effect reported.  This is one of several reports from the same reporter.
Age: 16.0
Sex: U
Vaccine: VARCEL, VARCEL
Symptoms: No adverse event, Product storage error
Clinical narrative: HCP called to report an expired dose of VARIVAX was administered to Multiple patients. Patient Demographics provided for all patients, please see notes for additional case numbers. HCP gave permission to contact. No symptoms reported. No further AE d; HCP called to report an expired dose of VARIVAX was administered to Multiple patients. Patient Demographics provided for all patients, please see notes for additional case numbers. HCP gave permission to contact. No symptoms reported. No further AE d; This spontaneous report was received from pharmacist and refers to a 16-year-old. Information regarding the patient's concurrent conditions, medical history, or concomitant medications was not provided.  On 12-JUN-2023, the patient was vaccinated with an improperly stored dose of measles, mumps, rubella and varicella virus vaccine live (oka/merck) (VARIVAX) administered for prophylaxis (formulation, route of administration, vaccination scheme frequency, and anatomical location were not provided; lot number WO252273 with expiration date of 02-JUN-2023 but upon internal validation established as W0252273 with an expiry date of 10-AUG-2024 (conflicting information as it was reported that the product was expired)). The administered dose of the vaccine experienced a temperature excursion of 70 degrees Fahrenheit for 9 minutes on 02-MAR-2023. It was not reported if the information was obtained from the data logger or not. There was no adverse effect reported.  This is one of several reports from the same reporter.
Sex: M
Vaccine: VARZOS
Symptoms: Cough, Illness, Nasal congestion
Clinical narrative: Extreme cough; Nasal congestion; Sick for two weeks; This serious case was reported by a consumer and described the occurrence of sickness in a 76-year-old male patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   On 01-JUN-2023, the patient received Shingles vaccine. In JUN-2023, an unknown time after receiving Shingles vaccine, the patient experienced sickness (Verbatim: Sick for two weeks) (serious criteria clinically significant/intervention required), cough (Verbatim: Extreme cough) and nasal congestion (Verbatim: Nasal congestion). In JUN-2023, the outcome of the sickness was resolved (duration 2 weeks). The outcome of the cough and nasal congestion were not reported.   It was unknown if the reporter considered the sickness, cough and nasal congestion to be related to Shingles vaccine.     It was unknown if the company considered the sickness, cough and nasal congestion to be related to Shingles vaccine.   Additional Information: GSK Receipt Date: 14-JUN-2023. This report was submitted via the online direct entry reporting system. Please process using the related. This report was submitted by public reporting. The patient was the reporter. Reporter seriousness for Sick for two weeks intervention required. Shingles vaccine manufacturer was unspecified. The patient did not receive other product. The patient was very sick with doctor's report and pills. The reporter gave permission to contact by email address.
Sex: M
Vaccine: VARZOS
Symptoms: Chills, Myalgia, Nerve injury
Clinical narrative: Shivering muscle ache nerve damage; Shivering muscle ache nerve damage; Shivering muscle ache nerve damage; This serious case was reported by a consumer and described the occurrence of shivering in a 63-year-old male patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   Concurrent medical conditions included lyme disease. Concomitant products included doxycycline hyclate and prednisone.   On 25-MAY-2023, the patient received Shingles vaccine. On 02-JUN-2023, 8 days after receiving Shingles vaccine, the patient experienced shivering (Verbatim: Shivering muscle ache nerve damage) (serious criteria clinically significant/intervention required), muscle pain (Verbatim: Shivering muscle ache nerve damage) (serious criteria clinically significant/intervention required) and nerve damage (Verbatim: Shivering muscle ache nerve damage) (serious criteria clinically significant/intervention required). The outcome of the shivering, muscle pain and nerve damage were not reported.   It was unknown if the reporter considered the shivering, muscle pain and nerve damage to be related to Shingles vaccine.     It was unknown if the company considered the shivering, muscle pain and nerve damage to be related to Shingles vaccine.   Additional Information: GSK Receipt Date: 19-JUN-2023 The patient self-reported this case. The reporter asked he/she would like to know what he/she should do to avoid death. The reporter consented to follow.
Sex: U
Vaccine: VARZOS
Symptoms: Expired product administered, Herpes zoster, Nerve injury, Pain, Vaccination failure
Clinical narrative: Get the vaccine. Mine had expired; got shingles / Suspected vaccination failure; got shingles; nerve damage; pain that never ends; Get the vaccine. Mine had expired; 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.   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: Get the vaccine. Mine had expired; got shingles/ Suspected vaccination failure) (serious criteria GSK medically significant), shingles (Verbatim: got shingles), nerve damage (Verbatim: nerve damage), pain (Verbatim: pain that never ends) and expired vaccine used (Verbatim: Get the vaccine. Mine had expired). The outcome of the vaccination failure and expired vaccine used were unknown and the outcome of the shingles, nerve damage and pain were not resolved.   It was unknown if the reporter considered the vaccination failure, shingles, nerve damage and pain to be related to Shingles vaccine.     It was unknown if the company considered the vaccination failure, shingles, nerve damage and pain to be related to Shingles vaccine.   Additional Information: GSK Receipt Date: 16-JUN-2023 This case was reported by the patient via interactive digital media. The reporter reported got the vaccine as his/her vaccine had expired and got shingles now had nerve damage with pain that never ends. This case was considered as suspected vaccination failure since the details regarding completion of primary vaccination schedule, time to onset and laboratory confirmation of shingles were unknown at the time of reporting.
Sex: U
Vaccine: VARZOS
Symptoms: Herpes zoster, Vaccination failure
Clinical narrative: Suspected vaccination failure; Got shingles after the shot; 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.   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: Suspected vaccination failure) (serious criteria GSK medically significant) and shingles (Verbatim: Got shingles after the shot). The outcome of the vaccination failure was unknown and the outcome of the shingles was not reported.   It was unknown if the reporter considered the vaccination failure and shingles to be related to Shingles vaccine.     It was unknown if the company considered the vaccination failure and shingles to be related to Shingles vaccine.   Additional Information: GSK receipt date: 15-Jun-2023 This case was reported the patient via interactive digital media. The patient got shingles after the shot. This case was considered as suspected vaccination failure as details regarding completion of primary vaccination schedule, time to onset and laboratory test confirming shingles were unknown at the time of reporting. Follow-up not possible as no contact details provided.
Sex: U
Vaccine: VARZOS
Symptoms: Eyelid rash, Oral herpes, Rash erythematous
Clinical narrative: Red area with bumps showed up by my left eye, underneath on outside of left eyelid; Cold sore; This non-serious case was reported by a consumer via call center representative and described the occurrence of red rash in a patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   The patient's past medical history included chickenpox.   On 22-MAR-2023, the patient received the 1st dose of Shingles vaccine. In APR-2023, 1 month after receiving Shingles vaccine, the patient experienced red rash (Verbatim: Red area with bumps showed up by my left eye, underneath on outside of left eyelid) and cold sores (Verbatim: Cold sore). The patient was treated with hydrocortisone and docosanol. The outcome of the red rash and cold sores were resolving.   It was unknown if the reporter considered the red rash and cold sores to be related to Shingles vaccine.     It was unknown if the company considered the red rash and cold sores to be related to Shingles vaccine.   Additional Information: GSK Receipt Date: 11-JUN-2023 and 14-JUN-2023 The patient received 1st dose of Shingles vaccine. Patient reported one month after receiving the vaccine had a red area with bumps showed up by left eye, underneath on outside of left eyelid.  Patient never had anything like this. Patient tried hydrocortisone cream 1% on it and it looked like it was going away, however it never did. Patient had PCP take a look and she recommended seeing a dermatologist.  Reporter had trouble getting in at dermatologist and appointment is scheduled on June 29th.  Patient just purchased some generic docosanol cream 10% to try on it.  It put it on very carefully with a Q-Tip and it appeared to be finally helping.  Patient had chicken pox as a child, but have never had a cold sore.  Patient read that the virus was related which prompted me to try Docosanol.
Sex: U
Vaccine: VARZOS
Symptoms: Diarrhoea, Injection site pain, Pain, Pyrexia, Vomiting
Clinical narrative: lot of pain in the arm where they gave me the vaccine; There was pain; temperature; vomiting; Diarrhea; This non-serious case was reported by a consumer via interactive digital media and described the occurrence of injection site pain in a patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   On an unknown date, the patient received Shingles vaccine (unknown arm). On an unknown date, an unknown time after receiving Shingles vaccine, the patient experienced injection site pain (Verbatim: lot of pain in the arm where they gave me the vaccine), pain (Verbatim: There was pain), fever (Verbatim: temperature), vomiting (Verbatim: vomiting) and diarrhea (Verbatim: Diarrhea). The outcome of the injection site pain, pain, fever, vomiting and diarrhea were not reported.   It was unknown if the reporter considered the injection site pain, pain, fever, vomiting and diarrhea to be related to Shingles vaccine.     It was unknown if the company considered the injection site pain, pain, fever, vomiting and diarrhea to be related to Shingles vaccine.   Additional Information: GSK Receipt date: 11-JUN-2023 This case was reported by patient via interactive digital media. The patient reported that there was pain, temperature, vomiting, diarrhea along with a lot of pain in the arm where they gave him or her the vaccine. The patient also stated that the reaction was strong for his/her body and not all people feel the same reaction as others hardly feel anything after vaccination. Follow up was not possible, as no contact details were available.
Sex: F
Vaccine: VARZOS
Symptoms: Pain
Clinical narrative: ache; This non-serious case was reported by a nurse via sales rep and described the occurrence of pain in a elderly female patient who received Herpes zoster (Shingrix) for prophylaxis.   On an unknown date, the patient received the 1st dose of Shingrix. On an unknown date, an unknown time after receiving Shingrix, the patient experienced pain (Verbatim: ache). The patient was treated with acyclovir. The outcome of the pain was not reported.   It was unknown if the reporter considered the pain to be related to Shingrix.     It was unknown if the company considered the pain to be related to Shingrix.   Linked case(s) involving the same patient:  US2023AMR083310   Additional Information: GSK Receipt date: 13-JUN-2023 The patient age was mid-70. The patient reported aches after each dose. Treated with acyclovir. The reporter did not consent to follow up.; Sender's Comments:  US-GSK-US2023AMR083310:same patient same reporter