chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 12.0
Sex: U
Vaccine: VARCEL
Symptoms: No adverse event, Product storage error
Clinical narrative: This spontaneous report was received from the Vaccine Coordinator referring to a 12 year old patient of unknown gender. The patient's medical history, concurrent conditions, concomitant medications, and historical drugs were not reported. On 14-SEP-2017, the patient was vaccinated with an improperly stored dose of VARIVAX with one of these lot #'s reported M017292, expiration date on 07-APR-2018; lot # N017701, expiration date on 09-JUN-2019 or with lot # N019127, expiration date on 22-JUN-2019 (Strength, route, dose, frequency, and anatomical location were unknown) for prophylaxis. There was no adverse effect reported. The administered dose of vaccine experienced the temperature excursion of 7.52 F degrees Fahrenheit for 24 hour, and had a previous temperature excursion of 5.5 F degrees Fahrenheit for 1 hour. There was a digital data logger involved. This is one of several reports received from the same reporter. Sender's Comments: US-009507513-1709USA008693.
Age: 1.25
Sex: U
Vaccine: VARCEL
Symptoms: No adverse event, Product storage error
Clinical narrative: This spontaneous report was received from the Vaccine Coordinator referring to a 15 month year old patient of unknown gender. The patient's medical history, concurrent conditions, concomitant medications, and historical drugs were not reported. On 28-SEP-2017, the patient was vaccinated with an improperly stored dose of VARIVAX with one of these lot #'s reported M017292, expiration date on 07-APR-2018; lot # N017701, expiration date on 09-JUN-2019 or with lot # N019127, expiration date on 22-JUN-2019 (Strength, route, dose, frequency, and anatomical location were unknown) for prophylaxis. There was no adverse effect reported. The administered dose of vaccine experienced the temperature excursion of 7.52 F degrees Fahrenheit for 24 hour, and had a previous temperature excursion of 5.5 F degrees Fahrenheit for 1 hour. There was a digital data logger involved. This is one of several reports received from the same reporter. Sender's Comments: US-009507513-1709USA008693.
Age: 5.0
Sex: U
Vaccine: VARCEL
Symptoms: No adverse event, Product storage error
Clinical narrative: This spontaneous report was received from the Vaccine Coordinator referring to a 5 year old patient of unknown gender. The patient's medical history, concurrent conditions, concomitant medications, and historical drugs were not reported. On 09-NOV-2017, the patient was vaccinated with an improperly stored dose of VARIVAX with one of these lot #'s reported M017292, expiration date on 07-APR-2018; lot # N017701, expiration date on 09-JUN-2019 or with lot # N019127, expiration date on 22-JUN-2019 (Strength, route, dose, frequency, and anatomical location were unknown) for prophylaxis. There was no adverse effect reported. The administered dose of vaccine experienced the temperature excursion of 7.52 F degrees Fahrenheit for 24 hour, and had a previous temperature excursion of 5.5 F degrees Fahrenheit for 1 hour. There was a digital data logger involved. This is one of several reports received from the same reporter. Sender's Comments: US-009507513-1709USA008693.
Age: 15.0
Sex: U
Vaccine: VARCEL
Symptoms: No adverse event, Product storage error
Clinical narrative: This spontaneous report was received from the Vaccine Coordinator referring to a 15 year old patient of unknown gender. The patient's medical history, concurrent conditions, concomitant medications, and historical drugs were not reported. On 16-NOV-2017, the patient was vaccinated with an improperly stored dose of VARIVAX with one of these lot #'s reported M017292, expiration date on 07-APR-2018; lot # N017701, expiration date on 09-JUN-2019 or with lot # N019127, expiration date on 22-JUN-2019 (Strength, route, dose, frequency, and anatomical location were unknown) for prophylaxis. There was no adverse effect reported. The administered dose of vaccine experienced the temperature excursion of 7.52 F degrees Fahrenheit for 24 hour, and had a previous temperature excursion of 5.5 F degrees Fahrenheit for 1 hour. There was a digital data logger involved. This is one of several reports received from the same reporter. Sender's Comments: US-009507513-1709USA008693.
Age: 12.0
Sex: U
Vaccine: VARCEL
Symptoms: No adverse event, Product storage error
Clinical narrative: This spontaneous report was received from the Vaccine Coordinator referring to a 12 year old patient of unknown gender. The patient's medical history, concurrent conditions, concomitant medications, and historical drugs were not reported. On 28-SEP-2017, the patient was vaccinated with an improperly stored dose of VARIVAX with one of these lot #'s reported M017292, expiration date on 07-APR-2018; lot # N017701, expiration date on 09-JUN-2019 or with lot # N019127, expiration date on 22-JUN-2019 (Strength, route, dose, frequency, and anatomical location were unknown) for prophylaxis. There was no adverse effect reported. The administered dose of vaccine experienced the temperature excursion of 7.52 F degrees Fahrenheit for 24 hour, and had a previous temperature excursion of 5.5 F degrees Fahrenheit for 1 hour. There was a digital data logger involved. This is one of several reports received from the same reporter. Sender's Comments: US-009507513-1709USA008693.
Age: 5.0
Sex: U
Vaccine: VARCEL
Symptoms: No adverse event, Product storage error
Clinical narrative: This spontaneous report was received from the Vaccine Coordinator referring to a 5 year old patient of unknown gender. The patient's medical history, concurrent conditions, concomitant medications, and historical drugs were not reported. On 28-SEP-2017, the patient was vaccinated with an improperly stored dose of VARIVAX with one of these lot #'s reported M017292, expiration date on 07-APR-2018; lot # N017701, expiration date on 09-JUN-2019 or with lot # N019127, expiration date on 22-JUN-2019 (Strength, route, dose, frequency, and anatomical location were unknown) for prophylaxis. There was no adverse effect reported.The administered dose of vaccine experienced the temperature excursion of 7.52 F degrees Fahrenheit for 24 hour, and had a previous temperature excursion of 5.5 F degrees Fahrenheit for 1 hour. There was a digital data logger involved. This is one of several reports received from the same reporter. Sender's Comments: US-009507513-1709USA008693.
Age: 1.25
Sex: U
Vaccine: VARCEL
Symptoms: No adverse event, Product storage error
Clinical narrative: This spontaneous report was received from the Vaccine Coordinator referring to a 15 month year old patient of unknown gender. The patient's medical history, concurrent conditions, concomitant medications, and historical drugs were not reported. On 14-DEC-2017, the patient was vaccinated with an improperly stored dose of VARIVAX with one of these lot #'s reported M017292, expiration date on 07-APR-2018; lot # N017701, expiration date on 09-JUN-2019 or with lot # N019127, expiration date on 22-JUN-2019 (Strength, route, dose, frequency, and anatomical location were unknown) for prophylaxis. There was no adverse effect reported. The administered dose of vaccine experienced the temperature excursion of 7.52 F degrees Fahrenheit for 24 hour, and had a previous temperature excursion of 5.5 F degrees Fahrenheit for 1 hour. There was a digital data logger involved. This is one of several reports received from the same reporter. Sender's Comments: US-009507513-1709USA008693.
Age: 26.0
Sex: U
Vaccine: VARCEL
Symptoms: No adverse event, Product storage error
Clinical narrative: This spontaneous report was received from the Vaccine Coordinator referring to a 26 year old patient of unknown gender. The patient's medical history, concurrent conditions, concomitant medications, and historical drugs were not reported. On 21-SEP-2017, the patient was vaccinated with an improperly stored dose of VARIVAX with one of these lot #'s reported M017292, expiration date on 07-APR-2018; lot # N017701, expiration date on 09-JUN-2019 or with lot # N019127, expiration date on 22-JUN-2019 (Strength, route, dose, frequency, and anatomical location were unknown) for prophylaxis. There was no adverse effect reported. The administered dose of vaccine experienced the temperature excursion of 7.52 F degrees Fahrenheit for 24 hour, and had a previous temperature excursion of 5.5 F degrees Fahrenheit for 1 hour. There was a digital data logger involved. This is one of several reports received from the same reporter. Sender's Comments: US-009507513-1709USA008693.
Age: 12.0
Sex: U
Vaccine: VARCEL
Symptoms: No adverse event, Product storage error
Clinical narrative: This spontaneous report was received from the Vaccine Coordinator referring to a 12 year old patient of unknown gender. The patient's medical history, concurrent conditions, concomitant medications, and historical drugs were not reported. On 07-DEC-2017, the patient was vaccinated with an improperly stored dose of VARIVAX with one of these lot #'s reported M017292, expiration date on 07-APR-2018; lot # N017701, expiration date on 09-JUN-2019 or with lot # N019127, expiration date on 22-JUN-2019 (Strength, route, dose, frequency, and anatomical location were unknown) for prophylaxis. There was no adverse effect reported. The administered dose of vaccine experienced the temperature excursion of 7.52 F degrees Fahrenheit for 24 hour, and had a previous temperature excursion of 5.5 F degrees Fahrenheit for 1 hour. There was a digital data logger involved. This is one of several reports received from the same reporter. Sender's Comments: US-009507513-1709USA008693.
Age: 5.0
Sex: U
Vaccine: VARCEL
Symptoms: No adverse event, Product storage error
Clinical narrative: This spontaneous report was received from the Vaccine Coordinator referring to a 5 year old patient of unknown gender. The patient's medical history, concurrent conditions, concomitant medications, and historical drugs were not reported. On 26-OCT-2017, the patient was vaccinated with an improperly stored dose of VARIVAX with one of these lot #'s reported M017292, expiration date on 07-APR-2018; lot # N017701, expiration date on 09-JUN-2019 or with lot # N019127, expiration date on 22-JUN-2019 (Strength, route, dose, frequency, and anatomical location were unknown) for prophylaxis. There was no adverse effect reported. The administered dose of vaccine experienced the temperature excursion of 7.52 F degrees Fahrenheit for 24 hour, and had a previous temperature excursion of 5.5 F degrees Fahrenheit for 1 hour. There was a digital data logger involved. This is one of several reports received from the same reporter. Sender's Comments: US-009507513-1709USA008693.
Age: 17.0
Sex: U
Vaccine: VARCEL
Symptoms: No adverse event, Product storage error
Clinical narrative: This spontaneous report was received from the Vaccine Coordinator referring to a 17 year old patient of unknown gender. The patient's medical history, concurrent conditions, concomitant medications, and historical drugs were not reported. On 07-DEC-2017, the patient was vaccinated with an improperly stored dose of VARIVAX with one of these lot #'s reported M017292, expiration date on 07-APR-2018; lot # N017701, expiration date on 09-JUN-2019 or with lot # N019127, expiration date on 22-JUN-2019 (Strength, route, dose, frequency, and anatomical location were unknown) for prophylaxis. There was no adverse effect reported. The administered dose of vaccine experienced the temperature excursion of 7.52 F degrees Fahrenheit for 24 hour, and had a previous temperature excursion of 5.5 F degrees Fahrenheit for 1 hour. There was a digital data logger involved. This is one of several reports received from the same reporter. Sender's Comments: US-009507513-1709USA008693.
Age: 15.0
Sex: U
Vaccine: VARCEL
Symptoms: No adverse event, Product storage error
Clinical narrative: This spontaneous report was received from the Vaccine Coordinator referring to a 15 year old patient of unknown gender. The patient's medical history, concurrent conditions, concomitant medications, and historical drugs were not reported. On 14-SEP-2017, the patient was vaccinated with an improperly stored dose of VARIVAX with one of these lot #'s reported M017292, expiration date on 07-APR-2018; lot # N017701, expiration date on 09-JUN-2019 or with lot # N019127, expiration date on 22-JUN-2019 (Strength, route, dose, frequency, and anatomical location were unknown) for prophylaxis. There was no adverse effect reported. The administered dose of vaccine experienced the temperature excursion of 7.52 F degrees Fahrenheit for 24 hour, and had a previous temperature excursion of 5.5 F degrees Fahrenheit for 1 hour. There was a digital data logger involved. This is one of several reports received from the same reporter. Sender's Comments: US-009507513-1709USA008693.
Age: 18.0
Sex: U
Vaccine: VARCEL
Symptoms: No adverse event, Product storage error
Clinical narrative: This spontaneous report was received from the Vaccine Coordinator referring to a 18 year old patient of unknown gender. The patient's medical history, concurrent conditions, concomitant medications, and historical drugs were not reported. On 14-SEP-2017, the patient was vaccinated with an improperly stored dose of VARIVAX with one of these lot #'s reported M017292, expiration date on 07-APR-2018; lot # N017701, expiration date on 09-JUN-2019 or with lot # N019127, expiration date on 22-JUN-2019 (Strength, route, dose, frequency, and anatomical location were unknown) for prophylaxis. There was no adverse effect reported. The administered dose of vaccine experienced the temperature excursion of 7.52 F degrees Fahrenheit for 24 hour, and had a previous temperature excursion of 5.5 F degrees Fahrenheit for 1 hour. There was a digital data logger involved. This is one of several reports received from the same reporter. Sender's Comments: US-009507513-1709USA008693.
Age: 5.0
Sex: U
Vaccine: VARCEL
Symptoms: No adverse event, Product storage error
Clinical narrative: This spontaneous report was received from the Vaccine Coordinator referring to a 5 year old patient of unknown gender. The patient's medical history, concurrent conditions, concomitant medications, and historical drugs were not reported. On 14-SEP-2017, the patient was vaccinated with an improperly stored dose of VARIVAX with one of these lot #'s reported M017292, expiration date on 07-APR-2018; lot # N017701, expiration date on 09-JUN-2019 or with lot # N019127, expiration date on 22-JUN-2019 (Strength, route, dose, frequency, and anatomical location were unknown) for prophylaxis. There was no adverse effect reported. The administered dose of vaccine experienced the temperature excursion of 7.52 F degrees Fahrenheit for 24 hour, and had a previous temperature excursion of 5.5 F degrees Fahrenheit for 1 hour. There was a digital data logger involved. This is one of several reports received from the same reporter. Sender's Comments: US-009507513-1709USA008693.
Age: 1.25
Sex: M
Vaccine: VARCEL
Symptoms: No adverse event, Product storage error
Clinical narrative: This spontaneous report was received from a medical assistant referring to 15 months old male patient. There was no information about the patient's concurrent conditions, concomitant therapies or medical history provided. On 11-JAN-2018, the patient was vaccinated with VARIVAX (lot # N019128, expiration date 22-JUN-2019) (dose and route of administration were not reported) for prophylaxis. There was no adverse effect reported. It was confirmed that sterile diluent (lot # M046371, expiration date 05-JUL-2019) used for reconstitution was properly stored. No adverse effects reported. Administered dose of vaccine experienced the temperature excursion of 6 degrees Fahrenheit to 14 degrees Fahrenheit for 56 hours 11 minutes. Data logger was involved. There were no previous excursions reported. This is one of several reports received from the same reporter.
Age: 1.17
Sex: M
Vaccine: VARCEL
Symptoms: No adverse event, Product storage error
Clinical narrative: This spontaneous report was received from a medical assistant referring to 1 year old male patient. There was no information about the patient's concurrent conditions, concomitant therapies or medical history provided. On 11-JAN-2018, the patient was vaccinated with VARIVAX (lot # N019128, expiration date 22-JUN-2019) (dose and route of administration were not reported) for prophylaxis. There was no adverse effect reported. It was confirmed that sterile diluent (lot # M046371, expiration date 05-JUL-2019) used for reconstitution was properly stored. No adverse effects reported. Administered dose of vaccine experienced the temperature excursion of 6 degrees Fahrenheit to 14 degrees Fahrenheit for 56 hours 11 minutes. Data logger was involved. There were no previous excursions reported. This is one of several reports received from the same reporter. Sender's Comments: US-009507513-1801USA007476: US-009507513-1801USA006791.
Age: 0.25
Sex: M
Vaccine: DTAPIPVHIB, PNC13, RV5
Symptoms: Apnoea, Cardio-respiratory arrest, Cyanosis, Death, Foaming at mouth
Clinical narrative: Child found unresponsive at 6:30 am on 1/13/2018, transported to ER via rescue squad, failed CPR, pronounced dead in ER. Mother last saw him alive at 1:30 am on 1/13/2018. Found unresponsive. This occurred several hours. Pt's parents found patient (3moM unresponsive at approx 630 am. Last seen at 130am. Arrives in full arrest with CPR in progress. Pt is cyanotic, unresponsive. No lividity but stiffness noted. Cool to touch, emesis noted. Pink froth noted in OP. Emesis pink indicating recent tx w/ PO TYLENOL (confirmed by Mother). Pt saw PCP earlier in the day for routine vaccinations. No sx/sx of acute allergic/hypersensitivity rxn. The patient was found unresponsive. Down time before CPR (Unknown - likely hours given hx.). Paramedics findings: The patient was apneic and pulseless. Prehospital treatment: Compressions performed.
Age: 0.25
Sex: M
Vaccine: DTAPIPVHIB, PNC13, RV5
Symptoms: Musculoskeletal stiffness, Peripheral coldness, Pulse absent, Resuscitation, Unresponsive to stimuli
Clinical narrative: Child found unresponsive at 6:30 am on 1/13/2018, transported to ER via rescue squad, failed CPR, pronounced dead in ER. Mother last saw him alive at 1:30 am on 1/13/2018. Found unresponsive. This occurred several hours. Pt's parents found patient (3moM unresponsive at approx 630 am. Last seen at 130am. Arrives in full arrest with CPR in progress. Pt is cyanotic, unresponsive. No lividity but stiffness noted. Cool to touch, emesis noted. Pink froth noted in OP. Emesis pink indicating recent tx w/ PO TYLENOL (confirmed by Mother). Pt saw PCP earlier in the day for routine vaccinations. No sx/sx of acute allergic/hypersensitivity rxn. The patient was found unresponsive. Down time before CPR (Unknown - likely hours given hx.). Paramedics findings: The patient was apneic and pulseless. Prehospital treatment: Compressions performed.
Age: 0.25
Sex: M
Vaccine: DTAPIPVHIB, PNC13, RV5
Symptoms: Vomiting
Clinical narrative: Child found unresponsive at 6:30 am on 1/13/2018, transported to ER via rescue squad, failed CPR, pronounced dead in ER. Mother last saw him alive at 1:30 am on 1/13/2018. Found unresponsive. This occurred several hours. Pt's parents found patient (3moM unresponsive at approx 630 am. Last seen at 130am. Arrives in full arrest with CPR in progress. Pt is cyanotic, unresponsive. No lividity but stiffness noted. Cool to touch, emesis noted. Pink froth noted in OP. Emesis pink indicating recent tx w/ PO TYLENOL (confirmed by Mother). Pt saw PCP earlier in the day for routine vaccinations. No sx/sx of acute allergic/hypersensitivity rxn. The patient was found unresponsive. Down time before CPR (Unknown - likely hours given hx.). Paramedics findings: The patient was apneic and pulseless. Prehospital treatment: Compressions performed.
Sex: U
Vaccine: HEPA
Symptoms: Hypoaesthesia, Loss of consciousness, Monoplegia, Paraesthesia
Clinical narrative: This case was reported by a other health professional via call center representative and described the occurrence of passed out in a adult patient who received HAVRIX. On an unknown date, the patient  received HAVRIX at an unknown dose. On an unknown date, several hours after receiving HAVRIX, the patient experienced passed out (serious criteria GSK medically significant), arm paralysis (serious criteria GSK medically significant), numbness of upper extremities and tingling of extremity. On an unknown date, the outcome of the passed out, arm paralysis, numbness of upper extremities and tingling of extremity were recovered/resolved. It was unknown if the reporter considered the passed out, arm paralysis, numbness of upper extremities and tingling of extremity to be related to HAVRIX. Additional information was provided as follows: The age at vaccination was not reported. The healthcare professional called to report that patient received HAVRIX and less than a month after receiving HAVRIX, the patient experienced temporary paralysis, numbness and tingling of the arm. The patient passed out at work hours later. The patient had to go to the emergency room. The healthcare professional not provided any patient specific information at this time. He said he purposefully was not answering callers questions. The patient received the vaccine sometime last week and he thought it was the first dose in the series but was not sure. He said he did not have all the information available at this time but it seem this person was trying to claim Workman's compensation and that is why he was calling. He said he would be willing to provide more information if the safety department wants to follow up with him at a later time.
Age: 64.0
Sex: F
Vaccine: FLU3
Symptoms: Drug administered to patient of inappropriate age
Clinical narrative: The patient is not 65 years old, which is required by the vaccination specifications.
Age: 36.0
Sex: F
Vaccine: FLU4
Symptoms: Injected limb mobility decreased, Injection site erythema, Injection site mass, Injection site pain, Injection site pruritus
Clinical narrative: Grapefruit size swollen, red, itchy, very painful lump at injection site. Pain in my entire left arm. Unable to bend my left elbow the next day. Low grade fever for one day. Migraine for 3 1/2 days. Severe body aches for 3 days.
Age: 36.0
Sex: F
Vaccine: FLU4
Symptoms: Injection site swelling, Migraine, Pain, Pain in extremity, Pyrexia
Clinical narrative: Grapefruit size swollen, red, itchy, very painful lump at injection site. Pain in my entire left arm. Unable to bend my left elbow the next day. Low grade fever for one day. Migraine for 3 1/2 days. Severe body aches for 3 days.
Age: 44.0
Sex: F
Vaccine: MMR
Symptoms: Body temperature increased, Cough, Influenza virus test negative, Oropharyngeal pain, Paranasal sinus hypersecretion
Clinical narrative: On 12/07/2017, after receiving the MMR, I began to develop cough, sore throat and sinus drainage that worsened over the next several days. On 12/12/2017, I went to my primary care provider for complaints of severe nonproductive cough, sore throat, elevated temperature, and sinus drainage. I was given oral antibiotics, cough medications, and nasal spray.
Age: 24.0
Sex: F
Vaccine: SMALL
Symptoms: Injection site erythema, Injection site pruritus
Clinical narrative: Afebrile, with noted erythema to left deltoid area (site of vaccine) measured as 8x5cm, non pustules, pruritics.
Age: 68.0
Sex: F
Vaccine: FLU3, PNC13
Symptoms: Chills, Eye pruritus, Influenza, Nasal congestion, Ocular hyperaemia
Clinical narrative: Pt reports bloodshot, itchy, watery eyes, chills, stuffy nose.
Age: 68.0
Sex: F
Vaccine: FLU3, PNC13
Symptoms: Sinusitis
Clinical narrative: Pt reports bloodshot, itchy, watery eyes, chills, stuffy nose.
Age: 0.33
Sex: M
Vaccine: DTAPIPVHIB, PNC13
Symptoms: Death
Clinical narrative: PATIENT DECEASED ON 01/16/18 (POSSIBLE SIDS) UNDER INVESTIGATION.
Age: 44.0
Sex: F
Vaccine: MMR
Symptoms: Cough, Headache, Oropharyngeal pain, Pain, Paranasal sinus hypersecretion
Clinical narrative: On the evening of 01/10/2018, I noticed 2 small, itchy, bumps on the back of my neck, just under the hairline. The next day there were 3 or 4. On 01/12/2018, I began coughing, sore throat, sinus drainage and headache. Over the next couple days, I noticed the rash was spreading. It was itchy and painful. I also had a low grade temp with cough, sore throat, headache, and sinus drainage. On 01/16/2018, I went to urgent care due to the rash had spread significantly. It was on the posterior neck, in the scalp, back, chest, left leg, and groin area. The rash continued to be itchy and painful. Treatment was BENADRYL or ZYRTEC, Calamine Lotion or Hydrocortisone Cream. Today there has been a decrease in the rash but remains present, continues to itch.
Age: 44.0
Sex: F
Vaccine: MMR
Symptoms: Pyrexia, Rash pruritic
Clinical narrative: On the evening of 01/10/2018, I noticed 2 small, itchy, bumps on the back of my neck, just under the hairline. The next day there were 3 or 4. On 01/12/2018, I began coughing, sore throat, sinus drainage and headache. Over the next couple days, I noticed the rash was spreading. It was itchy and painful. I also had a low grade temp with cough, sore throat, headache, and sinus drainage. On 01/16/2018, I went to urgent care due to the rash had spread significantly. It was on the posterior neck, in the scalp, back, chest, left leg, and groin area. The rash continued to be itchy and painful. Treatment was BENADRYL or ZYRTEC, Calamine Lotion or Hydrocortisone Cream. Today there has been a decrease in the rash but remains present, continues to itch.
Age: 1.08
Sex: M
Vaccine: MMRV, VARCEL
Symptoms: Extra dose administered, No adverse event
Clinical narrative: Inadvertently gave PROQUAD and Varicella at the same time. Contacted mother of child 1/17/18 and 1/18/18. Mother was informed of incident, risks related to incident, and instructed to seek immediate medical attention in case of an emergency. Mother states "he is doing fine. I haven't noticed anything unusual."
Age: 0.08
Sex: F
Vaccine: DTAPIPVHIB, HEP, PNC13, RV5
Symptoms: Tremor
Clinical narrative: On the morning of January 15th around 3 AM I woke up to hear my daughter let out a loud squeak. She started shaking her head back and forth really fast and then she started shaking head to toe, I rolled her onto her side and it subsided after 25-30 seconds. There wasn't any symptoms before hand, I checked her temp afterwards and it was 99.8 by underarm.
Sex: U
Vaccine: PPV
Symptoms: Expired product administered, No adverse event
Clinical narrative: Information has been received from a medical assistant referring to a patient of unknown age and gender. The patient's medical history, concurrent conditions, drug reactions or allergies and concomitant therapies were not reported. On 29-DEC-2017, the patient was vaccinated with an expired dose of PNEUMOVAX23 (expiry date 30-AUG-2017) for prophylaxis (dose, route of administration and lot number were not reported). No adverse effects were reported.
Sex: F
Vaccine: PNC13
Symptoms: Peripheral swelling
Clinical narrative: This is a spontaneous report from a contactable Pharmacist via Pfizer sales representative. A female patient of an unspecified age and ethnicity received PREVNAR 13, via an unspecified route of administration on an unspecified date at single dose for immunisation. The patient medical history and concomitant medications were not reported. The patient received pneumococcal 13-val conj vac (dipht crm197 protein) and her arm became swollen on an unspecified date with outcome of unknown. Information on the batch number has been requested.
Age: 68.0
Sex: F
Vaccine: PPV
Symptoms: Injection site bruising, Injection site swelling, Myalgia
Clinical narrative: Swelling then bruising at the site of PPSV23 injection. Swelling/Bruise extended from injection site to the medial border of the arm. Associated with myalgias.
Age: 71.0
Sex: F
Vaccine: PPV, PPV
Symptoms: Blood blister, Injection site extravasation, Injection site pain, Injection site reaction, Injection site swelling
Clinical narrative: Patient called 1/19 letting me know she had soreness at site of injection. I told her that is a normal reaction and that it should clear up in 2-3 days. On January 22 at approx. 9 AM she called to state she had a large leaking bump. She went to see her physician this afternoon on January 22 he stated that it may be an infection but unsure and that he was not "concerned" as the area was not surrounding red. She came and saw me after her appointment. I saw the large lump that looked much like a blood blister. I also submitted a report to Merck. Thank you.
Age: 71.0
Sex: F
Vaccine: PPV, PPV
Symptoms: Injection site discharge, Injection site mass, Injection site pain, Injection site swelling
Clinical narrative: Patient called 1/19 letting me know she had soreness at site of injection. I told her that is a normal reaction and that it should clear up in 2-3 days. On January 22 at approx. 9 AM she called to state she had a large leaking bump. She went to see her physician this afternoon on January 22 he stated that it may be an infection but unsure and that he was not "concerned" as the area was not surrounding red. She came and saw me after her appointment. I saw the large lump that looked much like a blood blister. I also submitted a report to Merck. Thank you.
Age: 11.0
Sex: F
Vaccine: MNQ, TDAP
Symptoms: Cellulitis
Clinical narrative: Cellulitis, KEFLEX 500 mg PO /3 TIMES A DAY for 10 days.
Age: 17.0
Sex: M
Vaccine: MNQ
Symptoms: Back pain, Epistaxis, Fatigue, Headache, Malaise
Clinical narrative: The day after his vaccine he reports not feeling well: back pain, vomiting, fatigue, headache, muscle aches, rash (Mom checking to see if rash blanches - not home with him right now), nose bleed this morning.
Age: 17.0
Sex: M
Vaccine: MNQ
Symptoms: Myalgia, Rash, Vomiting
Clinical narrative: The day after his vaccine he reports not feeling well: back pain, vomiting, fatigue, headache, muscle aches, rash (Mom checking to see if rash blanches - not home with him right now), nose bleed this morning.
Age: 75.0
Sex: F
Vaccine: PNC13
Symptoms: Pruritus, Rash generalised
Clinical narrative: RASH OVER LARGE AMOUNT OF BODY/ITCHING.
Age: 21.0
Sex: F
Vaccine: TDAP
Symptoms: Extra dose administered, No adverse event
Clinical narrative: Got Tdap at Physical 1-17-2018 No adverse reaction. Got Tdap 8-29-2017 ADACEL U5748AA Sanofi.
Age: 56.0
Sex: F
Vaccine: HEPAB, TDAP
Symptoms: Blister, Dehydration, Flank pain, Herpes zoster, Influenza
Clinical narrative: On 12/15 I had TB test. On 12/18 it was clear. On 12/22/17 I had Tetanus, Diphtheria, Pertussis and on 12/27/17 I had the Hep A and B. On 12/28 I had a blister on my right hand along with tingling and pain. The pain got more severe and my hand started breaking out more. That Sunday I was diagnosed with Shingles. Seven days later I was diagnosed with influenza, severe dehydration, a UTI and resp. issues. I am still having severe pain in my arm and right side even though all the blisters are gone except one.
Age: 56.0
Sex: F
Vaccine: HEPAB, TDAP
Symptoms: Pain in extremity, Paraesthesia, Respiratory disorder, Urinary tract infection
Clinical narrative: On 12/15 I had TB test. On 12/18 it was clear. On 12/22/17 I had Tetanus, Diphtheria, Pertussis and on 12/27/17 I had the Hep A and B. On 12/28 I had a blister on my right hand along with tingling and pain. The pain got more severe and my hand started breaking out more. That Sunday I was diagnosed with Shingles. Seven days later I was diagnosed with influenza, severe dehydration, a UTI and resp. issues. I am still having severe pain in my arm and right side even though all the blisters are gone except one.
Age: 1.33
Sex: F
Vaccine: DTAPIPVHIB, VARCEL
Symptoms: Rash, Rash pruritic
Clinical narrative: Broke out in spotty rash 10 days after VARIVAX. Pimple like, itchy-improved on day 11 post vaccination.
Age: 69.0
Sex: F
Vaccine: PPV
Symptoms: Injection site swelling, Peripheral swelling
Clinical narrative: Swelling at injection site beginning about 2 hours after injection. Swelling persisted through to Monday 1/22/2018 and is now developing past the elbow.
Age: 60.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site erythema, Injection site induration, Injection site pruritus
Clinical narrative: Shot site got red, also had a line about 4 inches long that was hard and itchy. After about 9 days the red mark has gone away. The hard line is now gone, but I still have some itchness in the area. I did not go to the doctor, I just waited to see if it would go away or get worse over the first weekend.  It did not get worse, but did take several days to go away.
Age: 13.0
Sex: M
Vaccine: MNQ, TDAP
Symptoms: Chest X-ray, Dyspnoea, Lip swelling, Swelling, Swollen tongue
Clinical narrative: A few hours after receiving immunizations the child began complaining of swelling of lips and tongue. Also swelling of chest and difficulty breathing.
Age: 66.0
Sex: F
Vaccine: PPV, TD
Symptoms: Chills, Joint range of motion decreased, Pyrexia, Skin warm, Swelling
Clinical narrative: Patient reports arm warm, swollen; Fever; Chills; decrease ROM. We had another patient have a reaction from the same office. For both they have a history of Neutropenia. Td was given at the same time as this vaccine.
Age: 22.0
Sex: F
Vaccine: FLU4, HPV9, PPV
Symptoms: Injection site erythema, Injection site pain, Injection site swelling, Pain
Clinical narrative: Left upper arm redness, pain and swelling began, within several hours worsened. Seen on 1/21/18 by provider. Location upper arm. Some body aches. No rash elsewhere. No right arm symptoms.
Age: 11.0
Sex: M
Vaccine: HPV4
Symptoms: Cold sweat, Crying, Dizziness, Presyncope, Urinary incontinence
Clinical narrative: Pt. upset prior to HPV injection, crying 5 min after shot was given pt became clammy and dizzy-urinated self-easily aroused-Examined by Dr.,  Vasovagal event. Had pt lay for 20 min-Left office in stable condition.
Sex: U
Vaccine: FLU4
Symptoms: Death, Influenza, Vaccination failure
Clinical narrative: This case was reported by a consumer via interactive digital media and described the occurrence of vaccination failure in a patient who received Influenza  vaccine Quadrivalent. Concomitant products included THERAFLU. On an unknown date, the patient received Influenza vaccine Quadrivalent. On an unknown date, unknown after receiving Influenza vaccine Quadrivalent, the patient experienced vaccination failure (serious criteria GSK medically significant) and influenza (serious criteria death and GSK medically significant). On an unknown date, the outcome of the vaccination failure was unknown and the outcome of the influenza was fatal. The reported cause of death was influenza. It was unknown if the reporter considered the vaccination failure and influenza to be related to Influenza vaccine Quadrivalent. Additional details were reported as follows: The age at vaccination was not reported. It was reported that, 8 patients died from flu of which 7 patients had flu shot and all eight patient's were on THERAFLU. This case was considered as suspected vaccination failure since time to onset and the lab test confirmation for the event was unknown. No further details provided about the product.
Sex: U
Vaccine: MMRV
Symptoms: No adverse event, Product storage error
Clinical narrative: Information has been received from a medical assistant referring to a multiple unspecified patients of unknown ages and genders. The patients' medical history, concurrent conditions, drug reactions or allergies and concomitant therapies were not reported. On an unknown multiple dates, the patients were vaccinated with an improperly stored doses of PROQUAD, (lot # N013865, expiry date 31-OCT-2018) for prophylaxis (dose and route of administration were not reported), the vaccine was; reconstituted with properly stored sterile diluent (manufacturer unknown), (lot # and expiry date were not reported). Administered doses of vaccines experienced a temperature excursion of 6 Fahrenheit (F) to 14 F for 8 hours and 45 minutes.  Additionally, the vaccine had previous excursions, which were: 6 F to 14 F  for 1 hour and 9 minutes, and another one of 15 F to 46 F  for 24 hours and 18 minutes. It was a call because of a data logger. No adverse effects were reported.
Sex: U
Vaccine: FLU4
Symptoms: Death, Influenza, Vaccination failure
Clinical narrative: This case was reported by a consumer via interactive digital media and described the occurrence of vaccination failure in a patient who received Influenza vaccine Quadrivalent. Concomitant products included THERAFLU. On an unknown date, the patient received Influenza vaccine Quadrivalent. On an unknown date, unknown after receiving Influenza vaccine Quadrivalent, the patient experienced vaccination failure (serious criteria GSK medically significant) and influenza (serious criteria death and GSK medically significant). On an unknown date, the outcome of the vaccination failure was unknown and the outcome of the influenza was fatal. The reported cause of death was influenza. It was unknown if the reporter considered the vaccination failure and influenza to be related to Influenza vaccine Quadrivalent. Additional details were reported as follows: The age at vaccination was not reported. It was reported that, 8 patients died from flu of which 7 patients had flu shot and all eight patients were on THERAFLU. This case was considered as suspected vaccination failure since time to onset and the lab test confirmation for the event was unknown. No further details provided about the product. This case was one of the 7 cases, reported by the same reporter.
Age: 5.0
Sex: F
Vaccine: FLU4
Symptoms: Injection site erythema, Injection site swelling
Clinical narrative: 3" area-pink and swollen @ inj. site. No hump no fever.
Sex: U
Vaccine: FLU4
Symptoms: Death, Influenza, Vaccination failure
Clinical narrative: This case was reported by a consumer via interactive digital media and described the occurrence of vaccination failure in a patient who received Influenza vaccine Quadrivalent. Concomitant products included THERAFLU. On an unknown date, the patient received Influenza vaccine Quadrivalent. On an unknown date, unknown after receiving Influenza vaccine Quadrivalent, the patient experienced vaccination failure (serious criteria GSK medically significant) and influenza (serious criteria death and GSK medically significant). On an unknown date, the outcome of the vaccination failure was unknown and the outcome of the influenza was fatal. The reported cause of death was influenza. It was unknown if the reporter considered the vaccination failure and influenza to be related to Influenza vaccine Quadrivalent. Additional details were reported as follows: The age at vaccination was not reported. It was reported that 8 patients died from flu of which 7 patients had flu shot and all eight patients were on THERAFLU. This case was considered as suspected vaccination failure since time to onset and the lab test confirmation for the event was unknown. No further details provided about the product. This case was one of the 7 cases, reported by the same reporter.
Age: 16.0
Sex: F
Vaccine: MENB
Symptoms: Rash
Clinical narrative: Rash.
Sex: U
Vaccine: FLU4
Symptoms: Death, Influenza, Vaccination failure
Clinical narrative: This case was reported by a consumer via interactive digital media and described the occurrence of vaccination failure in a patient who received Influenza vaccine Quadrivalent. Concomitant products included THERAFLU. On an unknown date, the patient received Influenza vaccine Quadrivalent. On an unknown date, unknown after receiving Influenza vaccine Quadrivalent, the patient experienced vaccination failure (serious criteria GSK medically significant) and influenza (serious criteria death and GSK medically significant). On an unknown date, the outcome of the vaccination failure was unknown and the outcome of the influenza was fatal. The reported cause of death was influenza. It was unknown if the reporter considered the vaccination failure and influenza to be related to Influenza vaccine Quadrivalent. Additional details were reported as follows: The age at vaccination was not reported. It was reported that, 8 patients died from flu of which 7 patients had flu shot and all eight patients were on THERAFLU. This case was considered as suspected vaccination failure since time to onset and the lab test confirmation for the event was unknown. No further details provided about the product.
Sex: U
Vaccine: FLU4
Symptoms: Death, Influenza, Vaccination failure
Clinical narrative: This case was reported by a consumer via interactive digital media and described the occurrence of vaccination failure in a patient who received Influenza vaccine quadrivalent. Concomitant products included THERAFLU. On an unknown date, the patient received Influenza vaccine quadrivalent. On an unknown date, unknown after receiving Influenza vaccine quadrivalent, the patient experienced vaccination failure (serious criteria GSK medically significant) and influenza (serious criteria death and GSK medically significant). On an unknown date, the outcome of the vaccination failure was unknown and the outcome of the influenza was fatal. The reported cause of death was influenza. It was unknown if the reporter considered the vaccination failure and influenza to be related to Influenza vaccine quadrivalent. Additional details were reported as follows: The age at vaccination was not reported. It was reported that, 8 patients died from flu of which 7 patients had flu shot and all eight patients were on THERAFLU. This case was considered as suspected vaccination failure since time to onset and the lab test confirmation for the event was unknown. No further details provided about the product. This case was one of the 7 cases, reported by the same reporter.
Age: 88.0
Sex: F
Vaccine: FLU4
Symptoms: Asthenia, Influenza, Tremor, Vaccination failure
Clinical narrative: This case was reported by a consumer via call center representative and described the occurrence of vaccination failure in a 88-year-old female patient who received Influenza vaccine Quadrivalent. Co-suspect products included ANORO ELLIPTA unknown for chronic obstructive pulmonary disease. Concomitant products included Albuterol, metoprolol and Supplement. In November 2017, the patient received Influenza vaccine Quadrivalent. On an unknown date, the patient started ANORO ELLIPTA 1 puff(s) once daily. On an unknown date, the dose was changed to an unknown dose and frequency. On 17th December 2017, less than a year after receiving Influenza vaccine Quadrivalent and not applicable after starting ANORO ELLIPTA, the patient experienced vaccination failure (serious criteria GSK medically significant) and influenza. On an unknown date, the patient experienced tremor and weakness. ANORO ELLIPTA was continued with no change. On an unknown date, the outcome of the vaccination failure was unknown and the outcome of the influenza was recovered/resolved and the outcome of the tremor and weakness were not recovered/not resolved. The reporter considered the vaccination failure and influenza to be unrelated to Influenza vaccine Quadrivalent. The reporter considered the tremor to be possibly related to Influenza vaccine Quadrivalent and ANORO ELLIPTA. It was unknown if the reporter considered the weakness to be related to Influenza vaccine Quadrivalent and ANORO ELLIPTA. The reporter considered the influenza to be unrelated to ANORO ELLIPTA. Additional details were provided as follows: The age at vaccination was not reported. In 2017, the patient received the flu vaccine a couple of months ago. She had been also on ANORO for about 2 months. The patient stated she experienced shakiness and weakness before she got the flu, these got worse with the flu, but at time of reporting, the flu had resolved but she had shakiness and weakness were still present at the time of reporting. She believed the shakiness and weakness began when she started ANORO. She also noted when she flew out of town on 17 December 2017, and spent a week in a hotel because that was when she got the flu. She did not know what flu shot she got. She can't recall all her other medications which she took, but noted those listed in this report. The patient had not notified her physician, but was encouraged to do so. She stated she had an appointment on 20th December 2017. She also provided contact details of the physician. This case was considered as suspected vaccination failure, since the exact time to onset of the event and confirmation of lab test was unknown.
Age: 70.0
Sex: F
Vaccine: PPV, TD
Symptoms: Chills, Injection site erythema, Injection site pruritus, Joint range of motion decreased, Malaise
Clinical narrative: Fever, decreased ROM; chills; malaise and achiness that prevented her from getting out of bed x 24 hours; Red; itchy; painful vaccine site.
Age: 70.0
Sex: F
Vaccine: PPV, TD
Symptoms: Mobility decreased, Pain, Pyrexia, Vaccination site pain
Clinical narrative: Fever, decreased ROM; chills; malaise and achiness that prevented her from getting out of bed x 24 hours; Red; itchy; painful vaccine site.
Age: 17.0
Sex: M
Vaccine: HEPA, HPV9, IPV, MNQ, VARCEL
Symptoms: Hyperhidrosis, Pallor, Presyncope
Clinical narrative: Patient was very nervous (crying) before vaccinations began. After last vaccination, patient appeared to begin to faint in chair--color faded in face, sweat broke out on forehead. Wet paper towels and cold packs were applied by nurses, cold water was given to patient to sip and lollipop which patient kept in mouth by holding with hand. Patient remained seated in treatment room for >45 minutes. Offered to call 9-1-1 but parents refused. Mother and stepfather were with child entire time. After patient stated he was feeling better, nurse walked him out to waiting area where he remained seated with parents nearby. After approximately 5 minutes in waiting room parents walked with him out to vehicle where family entered vehicle and left without incident.
Age: 4.0
Sex: F
Vaccine: DTAPIPV, MMR, VARCEL
Symptoms: Urticaria
Clinical narrative: MOP states that daughter woke up morning following her vaccinations with nickel size hives on her calves, elbows. MOP states that she put on a topical anti-itch steroidal cream and the hives went away. Patient did not seen bothered by the hives and had no other symptoms with her reaction. MOP states that the next morning, day 2 following vaccines, daughter woke up with nickel size hives again but on her back. MOP applied the same topical anti-itch steroidal cream and the hives went away. MOP reports no other symptoms.
Age: 22.0
Sex: M
Vaccine: TTOX
Symptoms: Depressed level of consciousness, Dizziness
Clinical narrative: Constant lightheadedness. Feeling like I'm going to pass out.
Age: 82.0
Sex: F
Vaccine: PPV
Symptoms: Injection site inflammation, Injection site pain, Injection site warmth
Clinical narrative: Pt complained of inflammation at the injection site and gradually moving down to her arm. Area is hot to touch and pain.
Age: 30.0
Sex: F
Vaccine: FLU4, MMR, TDAP
Symptoms: Fall, Photopsia, Respiratory rate increased, Skin warm
Clinical narrative: Client states that approximately 3 minutes after sitting in the waiting room for observation time, she noticed increased breathing/bright flashing lights/very warm/remembers being picked up off the floor by a man. The man that assisted our client to chair states that she had fallen forward out of chair and possibly hit head. Client states that she thinks she had hit the left side of her face and right knee. No redness/swelling/bruising noted.
Age: 67.0
Sex: M
Vaccine: FLU3, PNC13, VARZOS
Symptoms: Influenza, Malaise, Nasopharyngitis, Respiratory tract congestion
Clinical narrative: He got PREVNAR and flu shot from us on 1/14 (the same day, he got shingles from different pharmacy). He came today (1/22) and told me that he got sick (cold and flu-he sounded very congested) 2 days after. He said he got better over the week and he just wanted me to know. I explained to him that those are dead viruses and it could be just coincidence.
Age: 0.5
Sex: F
Vaccine: DTAPIPVHIB, PNC13, RV5
Symptoms: Rash, Rash erythematous, Urticaria
Clinical narrative: Pt was given ROTATEQ vaccine orally, waited 2-3 minutes and then administered IM vaccines. Pt then left with mom. As mom was loading pt into car she noticed red rash/welt type lesion on right side of face and immediately came back into clinic.