chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 39.0
Sex: F
Vaccine: ANTH
Symptoms: Erythema, Peripheral swelling, Pruritus, Skin warm
Clinical narrative: Swelling, redness over upper arm/bicep, which spread to chest, itching, hot to touch. Patient was given Benadryl, 25 mg PO at time of incident report, and stated no relief.
Age: 54.0
Sex: F
Vaccine: FLU3, PPV
Symptoms: Asthenia, Chills, Cough, Dizziness, Fatigue
Clinical narrative: Chills, fever of 102.5 for over three days, headaches, sharp pains all over body, cough, extreme fatigue, nausea to point of not being able to eat. Nausea, fatigue, dizziness, weakness, muscle pain has continued on. Extreme soreness of arm and arm is still swollen with red patches all over the area the shot was received.
Age: 54.0
Sex: F
Vaccine: FLU3, PPV
Symptoms: Feeding disorder, Headache, Injection site erythema, Malaise, Myalgia
Clinical narrative: Chills, fever of 102.5 for over three days, headaches, sharp pains all over body, cough, extreme fatigue, nausea to point of not being able to eat. Nausea, fatigue, dizziness, weakness, muscle pain has continued on. Extreme soreness of arm and arm is still swollen with red patches all over the area the shot was received.
Age: 54.0
Sex: F
Vaccine: FLU3, PPV
Symptoms: Nausea, Pain, Pain in extremity, Peripheral swelling, Pyrexia
Clinical narrative: Chills, fever of 102.5 for over three days, headaches, sharp pains all over body, cough, extreme fatigue, nausea to point of not being able to eat. Nausea, fatigue, dizziness, weakness, muscle pain has continued on. Extreme soreness of arm and arm is still swollen with red patches all over the area the shot was received.
Age: 47.0
Sex: F
Vaccine: FLU3
Symptoms: Dizziness, Headache, Lymphadenopathy, Nausea, Pharyngeal oedema
Clinical narrative: Patient given flu vaccine at 1:10pm on 9/12/2015. 1:15pm Signs of nausea and dizziness. 1:25pm Signs of headache and gland swelling. 1:30pm Tongue and throat slight swelling. 1:30pm EMT called. 1:33pm EpiPen 0.3mg injection administered in left thigh. 1:35pm Patient stated improvement in symptoms and breathing. 1:45pm Fire and Rescue arrived and began assessing patient. 1:50pm EMT arrive and take over pt care. 2:15pm Patient transported to ER.
Age: 47.0
Sex: F
Vaccine: FLU3
Symptoms: Swollen tongue
Clinical narrative: Patient given flu vaccine at 1:10pm on 9/12/2015. 1:15pm Signs of nausea and dizziness. 1:25pm Signs of headache and gland swelling. 1:30pm Tongue and throat slight swelling. 1:30pm EMT called. 1:33pm EpiPen 0.3mg injection administered in left thigh. 1:35pm Patient stated improvement in symptoms and breathing. 1:45pm Fire and Rescue arrived and began assessing patient. 1:50pm EMT arrive and take over pt care. 2:15pm Patient transported to ER.
Age: 74.0
Sex: F
Vaccine: FLU3
Symptoms: Erythema, Local swelling
Clinical narrative: RED SWOLLEN AREA OF 3 IN. X 2 IN. PATIENT HAS TAKEN BENADRYL AND WAS ADVISED TO APPLY A COLD COMPRESS TO AREA FOR 15 MIN. PT WILL MONITOR FOR BREATHING ISSUES.
Age: 26.0
Sex: F
Vaccine: DTAP
Symptoms: Lymph node pain, Lymphadenopathy, Rash, Rash pruritic
Clinical narrative: Painful, Itchy rash on back, armpit, breast and chest (all left side- Later diagnosed as Shingles). Swollen painful lymph node in left armpit.
Age: 3.0
Sex: F
Vaccine: MMR
Symptoms: Diarrhoea, Haematochezia, Lactose intolerance
Clinical narrative: Diarrhea with blood in stool. Repeated pattern after eating Lacoste within 5 minutes.
Age: 59.0
Sex: F
Vaccine: FLU3, PPV, VARZOS
Symptoms: Feeling hot, Hyperhidrosis, Nausea, Pallor, Respiratory rate increased
Clinical narrative: Felt hot, got sweaty, breathing rapidly, got very pale and felt like she would throw up. Gave an ice pack and monitored. She sat until 4:00 PM (25-30 minutes). Left feeling relatively well.
Age: 5.0
Sex: F
Vaccine: DTAP, IPV, MMR
Symptoms: Pyrexia, Rash
Clinical narrative: Mild fever, fluctuated over next several days, reaching peak at 101.5 degrees F. Developed rash of pink spots on neck, back, chest on 09/12/2015.
Age: 16.0
Sex: M
Vaccine: MEN
Symptoms: Dizziness, Pruritus, Rash
Clinical narrative: Slight Dizziness for about 45 minutes. The itching started about 7 PM and is still present. Raised bumps on the arms appeared the same evening of the day of the shot and increased in number throughout the day (today 9/12/2015).
Age: 9.0
Sex: M
Vaccine: TD
Symptoms: Asthma, Brain injury, Conjunctivitis allergic, Hypersensitivity, Irritability
Clinical narrative: Severe allergic reaction, brain damage, fussiness, and nasal allergic rhinitis, asthma, eye conjunctivitis allergy.
Age: 9.0
Sex: M
Vaccine: TD
Symptoms: Rhinitis allergic
Clinical narrative: Severe allergic reaction, brain damage, fussiness, and nasal allergic rhinitis, asthma, eye conjunctivitis allergy.
Age: 79.0
Sex: F
Vaccine: PNC13
Symptoms: Urticaria
Clinical narrative: Hive 4 inches in diameter which persists today, 6 days following the inoculation.
Age: 61.0
Sex: F
Vaccine: FLU4
Symptoms: Headache, Injection site hypersensitivity, Injection site reaction, Local reaction, Nodule
Clinical narrative: Received shingles shot on 9/9/15. Patient presented to the pharmacy on afternoon of 9/12 saying that she had been having headaches on 9/11 (not present 9/12) and showed pharmacy her arm, didn't report exact time she noticed it.  There was a red rash/nodule consistent with a local allergic reaction at the injection site.  Explained to patient that she was likely having an allergic reaction to vaccine, advised Benadryl and a hydrocortisone cream.  Patient stated she didn't want to purchase these items and might feel better if she went to an urgent care clinic.  Told patient it did appear to be allergic but understood if she wanted to get it looked at to ease her mind.  Went to urgent care clinic.  MD told her it could be allergic reaction, gave her Medrol dose pack along with antibiotic in case of any infection at the site.
Age: 61.0
Sex: F
Vaccine: FLU4
Symptoms: Rash erythematous
Clinical narrative: Received shingles shot on 9/9/15. Patient presented to the pharmacy on afternoon of 9/12 saying that she had been having headaches on 9/11 (not present 9/12) and showed pharmacy her arm, didn't report exact time she noticed it.  There was a red rash/nodule consistent with a local allergic reaction at the injection site.  Explained to patient that she was likely having an allergic reaction to vaccine, advised Benadryl and a hydrocortisone cream.  Patient stated she didn't want to purchase these items and might feel better if she went to an urgent care clinic.  Told patient it did appear to be allergic but understood if she wanted to get it looked at to ease her mind.  Went to urgent care clinic.  MD told her it could be allergic reaction, gave her Medrol dose pack along with antibiotic in case of any infection at the site.
Age: 60.0
Sex: F
Vaccine: FLU3, TTOX, VARZOS
Symptoms: Injection site erythema, Injection site pain, Injection site swelling
Clinical narrative: Injection site swelling, redness, soreness. 2 Advil taken, ongoing pain.
Age: 83.0
Sex: F
Vaccine: TDAP
Symptoms: Aggression, Cough, Dyspnoea, Wheezing
Clinical narrative: Became argumentive in car on ride home. Began wheezing and having shortness of breath within hours. Coughing lasting several days.
Age: 13.0
Sex: M
Vaccine: TDAP
Symptoms: Urticaria
Clinical narrative: Reaction: Hives. Treatment: Patient was given Benadryl.
Age: 67.0
Sex: F
Vaccine: PNC13
Symptoms: Dry mouth, Injection site erythema, Injection site pain, Injection site swelling, Injection site warmth
Clinical narrative: Soreness, redness, heat, swelling and pain at injection site.  Pain on moving the arm.  Joint stiffness (may be partly due to arthritis).  Dry mouth.  Still painful, swollen, red and hot three days later.
Age: 67.0
Sex: F
Vaccine: PNC13
Symptoms: Joint stiffness, Pain
Clinical narrative: Soreness, redness, heat, swelling and pain at injection site.  Pain on moving the arm.  Joint stiffness (may be partly due to arthritis).  Dry mouth.  Still painful, swollen, red and hot three days later.
Age: 25.0
Sex: F
Vaccine: ANTH
Symptoms: Injection site rash
Clinical narrative: Rash at insertion site for one week started day after vaccination.
Age: 65.0
Sex: F
Vaccine: FLU3
Symptoms: Diarrhoea, Oropharyngeal pain, Pyrexia, Vomiting
Clinical narrative: Vomiting, diarrhea, fever, sore throat.
Age: 57.0
Sex: F
Vaccine: PPV
Symptoms: Malaise, Myalgia, Nausea, Pain, Pyrexia
Clinical narrative: Fever <102F, malaise, nausea, swelling, soreness, myalgia.
Age: 57.0
Sex: F
Vaccine: PPV
Symptoms: Swelling
Clinical narrative: Fever <102F, malaise, nausea, swelling, soreness, myalgia.
Age: 40.0
Sex: F
Vaccine: FLU4
Symptoms: Injection site erythema, Injection site swelling, Injection site warmth
Clinical narrative: Injection site swelling (5 cm across), erythema, fever.
Age: 66.0
Sex: F
Vaccine: FLU3, VARZOS
Symptoms: Rash
Clinical narrative: Patient developed a rash on the opposite side of her from where the Zostavax vaccine was given.  Pt also recieved a HD flu shot on the same arm and rash was 3 inches below that shot.  Pt was concerned and went to an ER doctor who prescribed Keflex 500 1 qid for 7 days.
Age: 63.0
Sex: M
Vaccine: FLU3, PNC13
Symptoms: Contusion, Pain, Swelling
Clinical narrative: Pain, swelling, bruising. Was seen at urgent care and received prednisone and Benadryl.
Age: 2.0
Sex: F
Vaccine: PER, PPV
Symptoms: Erythema, Induration, Local swelling, Skin warm
Clinical narrative: Red hard hot bump about 2 inches in diameter.
Age: 57.0
Sex: F
Vaccine: FLUX
Symptoms: Dry mouth, Dry throat, Feeling cold, Moaning, Vomiting
Clinical narrative: As I was leaving the hospital I started feeling VERY cold. My husband got a blanket from the back of the car, put quickly got MUCH worse. I was moaning uncontrollably. My mouth and throat got very dry. Vomited at least 3-4 times. After a 15 minute ride home, I got under a few blankets, and fell asleep for about 2 hrs. I felt like none of it happened when I woke up.
Age: 68.0
Sex: F
Vaccine: FLU3
Symptoms: Injection site erythema, Injection site pain, Injection site swelling
Clinical narrative: Starting Fri 9/11/15 arm was achy and painful at injection site. On Sat 9/12/15 she reported redness abt the size of a softball around injection site and swelling.
Age: 71.0
Sex: F
Vaccine: FLU3
Symptoms: Chills, Fatigue, Malaise, Pain in extremity, Peripheral swelling
Clinical narrative: Chills, feel tired/sick, sore and swollen on left arm. Rest, sleep and lots of fluid. Pt recovered on 9/9/15.
Age: 66.0
Sex: F
Vaccine: FLU3
Symptoms: Chills, Malaise, Nausea, Pain, Pyrexia
Clinical narrative: For 1 night, fever approximately 100 degrees F-101 degree F; aches, chills, N/V, malaise; pt. reported no issues with FLUZONE HD last year.
Age: 66.0
Sex: F
Vaccine: FLU3
Symptoms: Vomiting
Clinical narrative: For 1 night, fever approximately 100 degrees F-101 degree F; aches, chills, N/V, malaise; pt. reported no issues with FLUZONE HD last year.
Age: 62.0
Sex: F
Vaccine: VARZOS
Symptoms: Herpes zoster, Rash, Vaccination failure
Clinical narrative: Information has been received from a 62 year old female consumer via company representative referring to herself. In approximately 2013 (reported as "at 60 year old"), the patient was vaccinated with ZOSTAVAX (lot#, expiration date, dose and route unspecified). In 2015 (at the reporting time), the patient had shingles, she was reporting the failure and her disappointment (Vaccination failure). Her torso was covered with the shingles rash. The outcome of events was unknown. The causality between the events and ZOSTAVAX was not reported. Additional information has been requested.
Sex: U
Vaccine: VARCEL
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: Information has been received from a healthcare professional referring to an unspecified number of patients of unknown age and gender. Information about medical history, concurrent condition and concomitant medication was not reported. On unknown dates the patients were vaccinated with VARIVAX (Merck) (lot # L002870 with expiration date of 27-JAN-2017, lot # K007786 with expiration date of 28-MAY-2016; strength, dosage, frequency and route unspecified), which were post temperature excursion. No adverse effects were noted by any patients. This is one of several reports received from the same reporter. Additional information has been requested.
Sex: U
Vaccine: HPV4
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: Information has been received from a healthcare professional referring to an unspecified number of patients of unknown age and gender. Information about medical history, concurrent condition and concomitant medications was not reported. On unknown dates the patients were vaccinated with GARDASIL (lot # K011562 with expiration date of 08-APR-2017; strength, dosage, frequency and route unspecified), which were post temperature excursion. No adverse effects were noted by any patients. This is one of several reports received from the same reporter. Additional information has been requested.
Sex: F
Vaccine: VARZOS
Symptoms: Burning sensation, Herpes zoster, Rash
Clinical narrative: Information was received from a non-pregnant female patient of unknown age referring to herself. The patient was taking medication for heart condition, diabetes, and acid reflux and was allergic to sulfa. In May 2015 the patient was vaccinated with ZOSTAVAX vial (strength, dose and route unknown) in the right arm at a pharmacy. Concomitant therapies included LIPITOR, NEXIUM and TOPROL XL tablets. On 22-AUG-2015 the patient developed a burning rash on her right shin and was diagnosed on 24-AUG-2015 by her physician as having shingles. The patient visited the physician's office and got prednisone (manufacturer unknown) and TERRASIL (an over the counter ointment) for treatment. No lab test was performed. The outcome of the event was reported as recovering. Additional information has been requested.
Sex: U
Vaccine: RV5
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: Information has been received from a healthcare professional referring to an unspecified number of patients of unknown age and gender. Information about medical history, concurrent condition and concomitant medications was not reported. On unknown dates the patients were vaccinated with ROTATEQ lot # K015816 with expiration date of 29-MAY-2016; strength, dosage and frequency unspecified orally, which were post temperature excursion. No adverse effects were noted by any patients. This is one of several reports received from the same reporter. Additional information has been requested.
Sex: U
Vaccine: HEPA
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: Information has been received from a healthcare professional referring to an unspecified number of patients of unknown age and gender. Information about medical history, concurrent condition and concomitant medications was not reported. On unknown dates the patients were vaccinated with VAQTA lot # L008665 with expiration date of 10-FEB-2017; strength, dosage, frequency and route unspecified), which were post temperature excursion. No adverse effects were noted by any patients. This is one of several reports received from the same reporter. Additional information has been requested.
Sex: U
Vaccine: RV5
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: Information has been received from a healthcare worker referring to unspecified patients of unknown age and gender. On unknown dates the patients were vaccinated with oral, ROTATEQ (batch#/lot# L000425, expiration date and dose were unknown) which were exposed to temperatures outside of the recommended range. No adverse events were reported. This is one of several reports received from the same reporter. Additional information has been requested.
Sex: U
Vaccine: MMR
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This initial spontaneous report was received from a healthcare worker referring to multiple unspecified patients of unknown ages and genders. There was no pertinent medical history, concomitant medication or drug allergies/drug reactions reported. The healthcare worker noted that on unspecified dates, the patients were administered improperly stored M-M-R II injection (dose, route, albumin status, lot number and expiration date were not provided). No adverse effects were reported. It was unknown if the patients sought medical attention. No product quality complaint was involved. This is one of several reports received from the same reporter. Additional information has been requested.
Age: 13.0
Sex: F
Vaccine: HPV4
Symptoms: Arthralgia
Clinical narrative: Information has been received from a nurse referring to a 13 year old female patient. The patient had no pertinent medical history and no drug allergies. On 03-NOV-2014, the patient was vaccinated with her first dose of GARDASIL intramuscularly (dose and lot # were not reported). The second dose was given on an unknown date. On 05-MAY-2015, the patient received the third dose (lot # reported as 1007531, expiration date unspecified). There was no concomitant therapy. On 15-MAY-2015, the patient experienced arthralgia and aching in her knees and ankles. The patient's father called a physician for medial attention. Unspecified dose of ibuprofen as needed was given to the patient as treatment. No lab test was done. At the time of this report, the patient had not recovered from the event. The causality between the event and the vaccine was not reported. Additional information has been requested.
Age: 65.0
Sex: M
Vaccine: PNC13
Symptoms: Urticaria
Clinical narrative: Information has been received from a physician via a company representative referring to a 65 year old male patient. The patient's pertinent medical history and drug allergies were not reported. On an unknown date the patient received a dose of PNEUMOVAX 23 (dose, strength and route unknown) in his fifties. There was no adverse effect reported post PNEUMOVAX 23 administration. The physician stated that patient had unspecified co-morbid conditions that met indications for a dose of PREVNAR 13 which was administered to the patient (dose, strength and route unknown) on an unknown date at the age of 65 years. Then on an unknown date the patient developed urticaria post PREVNAR 13 vaccination. At the time of reporting, the outcome of urticaria was unknown. The causality was not reported. Additional information has been requested.
Sex: U
Vaccine: HEP
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: Information has been received from a healthcare professional referring to an unspecified number of patients of unknown age and gender. Information about medical history, concurrent condition and concomitant medications was not reported. On unknown dates the patients were vaccinated with RECOMBIVAX HB lot # K010535 with expiration date 27-AUG-2016; strength, dosage, frequency and route unspecified), which were post temperature excursion No adverse effects were noted by any patients. This is one of several reports received from the same reporter. Additional information has been requested.
Sex: U
Vaccine: VARZOS
Symptoms: Drug administered at inappropriate site, No adverse event
Clinical narrative: Information has been received from a pharmacist referring to multiple unspecified patients of unknown age and gender. There was no information about the patients' medical history and concurrent condition. The reporter reported that she had been administering ZOSTAVAX via dry subcutaneously to these patients on unknown dates to the under arm area instead of the deltoid region (lot# and dose unknown). In additional the pharmacist stated that she gave ZOSTAVAX at more of a "90 degree angle than a 45 degree angle with a 5/8 inch needle". There was no information about concomitant therapy. No adverse effects were reported. Additional information has been requested.
Sex: U
Vaccine: MMRV
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: Information has been received from a healthcare professional referring to an unspecified number of patients of unknown age and gender. Information about medical history, concurrent condition and concomitant medications was not reported. On unknown dates the patients were vaccinated with PROQUAD (lot # K023861 with expiration date of 25-MAY-2016, lot # K005644 with expiration date of 17-OCT-2015; strength, dosage, frequency and route unspecified), which were post temperature excursion. No adverse effects were noted by any patients. This is one of several reports received from the same reporter. Additional information has been requested.
Age: 21.0
Sex: M
Vaccine: ANTH, SMALL, TYP
Symptoms: Post vaccination autoinoculation
Clinical narrative: This case was received on 27 August 2014 via a third party query tool search on the VAERS database, under reference number 532153. A 21 year-old male patient had received the following vaccines on 07 May 2014, a left arm injection of ACAM2000 (lot number VV04003A), an intramuscular right arm injection of TYPHIM VI, lot number J1631 and an intramuscular right arm injection of BIOTHRAX (lot number FAV365A) and 21 days later on 28 May 2014, was found to have autoinoculation from smallpox. Treatments were not reported. Lab data was provider examination. Current illnesses and history were none known. Other medications and prior vaccinations were not reported. No further information was available at the time of the report. Outcome was unknown. Documents held by sender: none.
Age: 29.0
Sex: F
Vaccine: ANTH, SMALL, TYP
Symptoms: Anaphylactic reaction, Autonomic nervous system imbalance, Biopsy bone marrow normal, C-kit gene negative, Chills
Clinical narrative: This case was received on 05 December 2014 via a third party query tool search on the VAERS database, under reference number 544495. A 29 year-old female patient in her normal (excellent) state of health with no significant past medical history had received the following vaccinations on 30 March 2011: ACAM2000 (lot number and site of administration not reported), an intramuscular injection of Typhoid vaccine (lot number E0302-1 and site of administration not reported) and a dose of Anthrax (other manufacturer lot number FAV269 and route, site of administration not reported) and immediately post vaccinations, the patient described feeling ill immediately after these vaccines to include symptoms of fever, chills, nausea and fatigue. Symptoms slowly progressed in nature to include GI symptoms, dysautonomia and frank anaphylactic episodes. Anaphylactic episodes were associated with elevated serum tryptase and urinary histamine levels. Patient eventually was diagnosed with MCAS after mastocytosis and monoclonal disorders were ruled out. Patient failed treatment with imatinib but is currently being successfully managed with SUTENT. Patient has known somatic gene mutation of kit gene on exon 11 (F584C) causing gain of function mutation. Lab data included: Bone marrow biopsy: negative for mastocytosis; Elevated serum tryptase and urinary histamine levels during attacks (normal at baseline); C-kit 816 gene: normal; Exon 11 kit gene gain of function gene mutation (F584C). The patient had a remote history of erythromycin allergy otherwise no history of atopy. Current illnesses and other medications were reported as none. The event was considered life threatening requiring an emergency visit. The patient's outcome was disabled and not recovered. Note: Albright's syndrome seems to be coded in error. The patient experienced Mast cell syndrome (MCAS). Documents held by sender: none.
Age: 29.0
Sex: F
Vaccine: ANTH, SMALL, TYP
Symptoms: Fatigue, Gastrointestinal disorder, Histamine normal, Immediate post-injection reaction, Malaise
Clinical narrative: This case was received on 05 December 2014 via a third party query tool search on the VAERS database, under reference number 544495. A 29 year-old female patient in her normal (excellent) state of health with no significant past medical history had received the following vaccinations on 30 March 2011: ACAM2000 (lot number and site of administration not reported), an intramuscular injection of Typhoid vaccine (lot number E0302-1 and site of administration not reported) and a dose of Anthrax (other manufacturer lot number FAV269 and route, site of administration not reported) and immediately post vaccinations, the patient described feeling ill immediately after these vaccines to include symptoms of fever, chills, nausea and fatigue. Symptoms slowly progressed in nature to include GI symptoms, dysautonomia and frank anaphylactic episodes. Anaphylactic episodes were associated with elevated serum tryptase and urinary histamine levels. Patient eventually was diagnosed with MCAS after mastocytosis and monoclonal disorders were ruled out. Patient failed treatment with imatinib but is currently being successfully managed with SUTENT. Patient has known somatic gene mutation of kit gene on exon 11 (F584C) causing gain of function mutation. Lab data included: Bone marrow biopsy: negative for mastocytosis; Elevated serum tryptase and urinary histamine levels during attacks (normal at baseline); C-kit 816 gene: normal; Exon 11 kit gene gain of function gene mutation (F584C). The patient had a remote history of erythromycin allergy otherwise no history of atopy. Current illnesses and other medications were reported as none. The event was considered life threatening requiring an emergency visit. The patient's outcome was disabled and not recovered. Note: Albright's syndrome seems to be coded in error. The patient experienced Mast cell syndrome (MCAS). Documents held by sender: none.
Age: 29.0
Sex: F
Vaccine: ANTH, SMALL, TYP
Symptoms: Mast cell activation syndrome, Nausea, Pyrexia, Tryptase increased
Clinical narrative: This case was received on 05 December 2014 via a third party query tool search on the VAERS database, under reference number 544495. A 29 year-old female patient in her normal (excellent) state of health with no significant past medical history had received the following vaccinations on 30 March 2011: ACAM2000 (lot number and site of administration not reported), an intramuscular injection of Typhoid vaccine (lot number E0302-1 and site of administration not reported) and a dose of Anthrax (other manufacturer lot number FAV269 and route, site of administration not reported) and immediately post vaccinations, the patient described feeling ill immediately after these vaccines to include symptoms of fever, chills, nausea and fatigue. Symptoms slowly progressed in nature to include GI symptoms, dysautonomia and frank anaphylactic episodes. Anaphylactic episodes were associated with elevated serum tryptase and urinary histamine levels. Patient eventually was diagnosed with MCAS after mastocytosis and monoclonal disorders were ruled out. Patient failed treatment with imatinib but is currently being successfully managed with SUTENT. Patient has known somatic gene mutation of kit gene on exon 11 (F584C) causing gain of function mutation. Lab data included: Bone marrow biopsy: negative for mastocytosis; Elevated serum tryptase and urinary histamine levels during attacks (normal at baseline); C-kit 816 gene: normal; Exon 11 kit gene gain of function gene mutation (F584C). The patient had a remote history of erythromycin allergy otherwise no history of atopy. Current illnesses and other medications were reported as none. The event was considered life threatening requiring an emergency visit. The patient's outcome was disabled and not recovered. Note: Albright's syndrome seems to be coded in error. The patient experienced Mast cell syndrome (MCAS). Documents held by sender: none.
Age: 25.0
Sex: M
Vaccine: ANTH, FLUC3, SMALL, TYP, ANTH, FLUC3, SMALL, TYP
Symptoms: Delusion, Hyperhidrosis, Hypotension, Insomnia, Pallor
Clinical narrative: This unsolicited case was received on 22-May-2015 via a third party query tool search on the VAERS database, under reference number: 560922. A 25-year-old male patient had received the following vaccinations on 18-Oct-2014: A dose of ACAM2000 (lot number: VV04003A, manufacturer: Sanofi Pasteur Biologics Co) via "intradermal" route, site was reported as unknown, a dose of TYPHIM VI (lot number: K11831, manufacturer: Sanofi Pasteur SA) via intramuscular route, site was reported as unknown, a first dose of FLUCELVAX (lot number: 160234, manufacturer: Novartis) via intramuscular route, site was reported as unknown and a dose of BIOTHRAX (lot number: FAV387A, manufacturer: Emergent) via intramuscular route, site was reported as unknown. The patient denied any medical history. The current illnesses and other medications were reported as none known. Prior vaccination details were not provided. On 18-Oct-2014, same day post-vaccination, he developed a brief near-syncope episode; he had hypotension (approximately 80/40) and was pale and diaphoretic. It was reported later that he experienced sweating, was delusional, had high fever and could not sleep. The temperature was not recorded by the patient. On 19-Oct-2014, early in the morning, he went to an urgent care. He was asked to return, if the symptoms worsened. The patient reported that he did not receive any medications. There was no laboratory investigations done and corrective treatment was not provided. At the time of this report, the outcome for the events was not reported. List of Documents held by sender: none.
Age: 25.0
Sex: M
Vaccine: ANTH, FLUC3, SMALL, TYP, ANTH, FLUC3, SMALL, TYP
Symptoms: Presyncope, Pyrexia
Clinical narrative: This unsolicited case was received on 22-May-2015 via a third party query tool search on the VAERS database, under reference number: 560922. A 25-year-old male patient had received the following vaccinations on 18-Oct-2014: A dose of ACAM2000 (lot number: VV04003A, manufacturer: Sanofi Pasteur Biologics Co) via "intradermal" route, site was reported as unknown, a dose of TYPHIM VI (lot number: K11831, manufacturer: Sanofi Pasteur SA) via intramuscular route, site was reported as unknown, a first dose of FLUCELVAX (lot number: 160234, manufacturer: Novartis) via intramuscular route, site was reported as unknown and a dose of BIOTHRAX (lot number: FAV387A, manufacturer: Emergent) via intramuscular route, site was reported as unknown. The patient denied any medical history. The current illnesses and other medications were reported as none known. Prior vaccination details were not provided. On 18-Oct-2014, same day post-vaccination, he developed a brief near-syncope episode; he had hypotension (approximately 80/40) and was pale and diaphoretic. It was reported later that he experienced sweating, was delusional, had high fever and could not sleep. The temperature was not recorded by the patient. On 19-Oct-2014, early in the morning, he went to an urgent care. He was asked to return, if the symptoms worsened. The patient reported that he did not receive any medications. There was no laboratory investigations done and corrective treatment was not provided. At the time of this report, the outcome for the events was not reported. List of Documents held by sender: none.
Age: 20.0
Sex: M
Vaccine: ANTH, SMALL, TYP, ANTH, SMALL, TYP
Symptoms: Stevens-Johnson syndrome
Clinical narrative: This unsolicited case was received on 22-May-2015 via a third party query tool search on the VAERS database, under reference number 566732. A 20-year-old male patient received the following vaccinations on 20-Jan-2015: a first dose of ACAM2000 (lot number VV04003A, manufacturer: Sanofi Pasteur Biologics Co) in the right arm via an unknown route, a first dose of TYPHIM VI (lot number J05021, manufacturer: Sanofi Pasteur SA) intramuscularly in the left arm and a first dose of BIOTHRAX (lot number FAV387A, manufacturer: Emergent) intramuscularly in the left arm. The medical history, current illnesses and other medications were reported as none. The prior vaccination details were not reported. On 28-Jan-2015, 8 days post-vaccination, the patient experienced Stevens-Johnson syndrome. The patient had an emergency visit and was hospitalized on an unspecified date. Laboratory data and corrective treatments were not provided. At the time of this report, the outcome was reported as unknown. List of documents held by sender: none.
Age: 22.0
Sex: F
Vaccine: HEPA, MNQ, TYP, YF, HEPA, MNQ, TYP, YF
Symptoms: Balance disorder, Burning sensation, Dizziness, Ear pain, Headache
Clinical narrative: Initial unsolicited report received from a nurse on 04 June 2015. A 22-year-old female patient, had received a first dose of YF VAX (batch number: UI081AB, expiry date: 19 June 2016, dose were not reported) via subcutaneous route in left arm, first dose of TYPHIM VI (batch number: K1200-1, expiry date, dose were not reported) via intramuscular route in left deltoid, a dose of HAVRIX (batch number: XD72G, expiry date, dose, dose in series, route and site of administration were not reported) and a dose of MENVEO (batch number: M14008, expiry date, dose, dose in series were not reported) via intramuscular route in right deltoid on 02 June 2015. Medical history and concomitant medications were not reported. Patient's illness at the time of vaccination reported as none. The patient's pre-existing physician diagnosed allergies, birth defects, medical conditions reported as AUGMENTIN allergy. On 03 June 2015, the patient's base of the skull was burning and hurting which was so severe that she could not lay head on pillow, ears and while turning head towards left it were hurting, the left ear and left side of head hurts worse than the right. Also, the patient was lightheaded, off balance and developed tender arms at injection sites. Patient required ER/doctor visit. Laboratory investigations included body temperature: 97.8 Fahrenheit. Corrective treatments were not reported. At the time of this report, the patient was not recovered. Documents held by sender: none. Follow up information received from a nurse on 27-Jul-2015. The patient details were provided. There were no other vaccinations within 4 weeks prior to the date of vaccination and no concomitant medications were taken. The pre-existing physician diagnosed allergies, birth defects, medical conditions included AUGMENTIN allergy (cause was nausea, vomiting and abdominal pain). There was no illness at the time of vaccination. The patient had received a 0.5 ml dose of YF VAX, a 0.5 ml dose of TYPHIM VI, a 1 ml dose of HAVRIX (manufacturer: GlaxoSmithKline, batch number: XD726 via intramuscular route in the right deltoid) and a 0.5 ml dose of MENVEO (manufacturer: Novartis, batch number: M14088 via intramuscular route in the right deltoid) on 02 June 2015, at approximately 18:00 hours. On 04-Jun-2015, 2 days post-vaccination at 03 to 03:30 hours in the morning, the patient was lightheaded and off balance. The adverse event was previously reported to Sanofi Pasteur. No laboratory investigations were done. The patient did not require ER/doctor visit. At the time of this report, the patient had recovered from the above mentioned events on an unspecified date. Documents held by sender: none.
Age: 22.0
Sex: F
Vaccine: HEPA, MNQ, TYP, YF, HEPA, MNQ, TYP, YF
Symptoms: Pain
Clinical narrative: Initial unsolicited report received from a nurse on 04 June 2015. A 22-year-old female patient, had received a first dose of YF VAX (batch number: UI081AB, expiry date: 19 June 2016, dose were not reported) via subcutaneous route in left arm, first dose of TYPHIM VI (batch number: K1200-1, expiry date, dose were not reported) via intramuscular route in left deltoid, a dose of HAVRIX (batch number: XD72G, expiry date, dose, dose in series, route and site of administration were not reported) and a dose of MENVEO (batch number: M14008, expiry date, dose, dose in series were not reported) via intramuscular route in right deltoid on 02 June 2015. Medical history and concomitant medications were not reported. Patient's illness at the time of vaccination reported as none. The patient's pre-existing physician diagnosed allergies, birth defects, medical conditions reported as AUGMENTIN allergy. On 03 June 2015, the patient's base of the skull was burning and hurting which was so severe that she could not lay head on pillow, ears and while turning head towards left it were hurting, the left ear and left side of head hurts worse than the right. Also, the patient was lightheaded, off balance and developed tender arms at injection sites. Patient required ER/doctor visit. Laboratory investigations included body temperature: 97.8 Fahrenheit. Corrective treatments were not reported. At the time of this report, the patient was not recovered. Documents held by sender: none. Follow up information received from a nurse on 27-Jul-2015. The patient details were provided. There were no other vaccinations within 4 weeks prior to the date of vaccination and no concomitant medications were taken. The pre-existing physician diagnosed allergies, birth defects, medical conditions included AUGMENTIN allergy (cause was nausea, vomiting and abdominal pain). There was no illness at the time of vaccination. The patient had received a 0.5 ml dose of YF VAX, a 0.5 ml dose of TYPHIM VI, a 1 ml dose of HAVRIX (manufacturer: GlaxoSmithKline, batch number: XD726 via intramuscular route in the right deltoid) and a 0.5 ml dose of MENVEO (manufacturer: Novartis, batch number: M14088 via intramuscular route in the right deltoid) on 02 June 2015, at approximately 18:00 hours. On 04-Jun-2015, 2 days post-vaccination at 03 to 03:30 hours in the morning, the patient was lightheaded and off balance. The adverse event was previously reported to Sanofi Pasteur. No laboratory investigations were done. The patient did not require ER/doctor visit. At the time of this report, the patient had recovered from the above mentioned events on an unspecified date. Documents held by sender: none.
Age: 22.0
Sex: F
Vaccine: HEPA, MNQ, TYP, YF, HEPA, MNQ, TYP, YF
Symptoms: Injection site pain, Pain
Clinical narrative: Initial unsolicited report received from a nurse on 04 June 2015. A 22-year-old female patient, had received a first dose of YF VAX (batch number: UI081AB, expiry date: 19 June 2016, dose were not reported) via subcutaneous route in left arm, first dose of TYPHIM VI (batch number: K1200-1, expiry date, dose were not reported) via intramuscular route in left deltoid, a dose of HAVRIX (batch number: XD72G, expiry date, dose, dose in series, route and site of administration were not reported) and a dose of MENVEO (batch number: M14008, expiry date, dose, dose in series were not reported) via intramuscular route in right deltoid on 02 June 2015. Medical history and concomitant medications were not reported. Patient's illness at the time of vaccination reported as none. The patient's pre-existing physician diagnosed allergies, birth defects, medical conditions reported as AUGMENTIN allergy. On 03 June 2015, the patient's base of the skull was burning and hurting which was so severe that she could not lay head on pillow, ears and while turning head towards left it were hurting, the left ear and left side of head hurts worse than the right. Also, the patient was lightheaded, off balance and developed tender arms at injection sites. Patient required ER/doctor visit. Laboratory investigations included body temperature: 97.8 Fahrenheit. Corrective treatments were not reported. At the time of this report, the patient was not recovered. Documents held by sender: none. Follow up information received from a nurse on 27-Jul-2015. The patient details were provided. There were no other vaccinations within 4 weeks prior to the date of vaccination and no concomitant medications were taken. The pre-existing physician diagnosed allergies, birth defects, medical conditions included AUGMENTIN allergy (cause was nausea, vomiting and abdominal pain). There was no illness at the time of vaccination. The patient had received a 0.5 ml dose of YF VAX, a 0.5 ml dose of TYPHIM VI, a 1 ml dose of HAVRIX (manufacturer: GlaxoSmithKline, batch number: XD726 via intramuscular route in the right deltoid) and a 0.5 ml dose of MENVEO (manufacturer: Novartis, batch number: M14088 via intramuscular route in the right deltoid) on 02 June 2015, at approximately 18:00 hours. On 04-Jun-2015, 2 days post-vaccination at 03 to 03:30 hours in the morning, the patient was lightheaded and off balance. The adverse event was previously reported to Sanofi Pasteur. No laboratory investigations were done. The patient did not require ER/doctor visit. At the time of this report, the patient had recovered from the above mentioned events on an unspecified date. Documents held by sender: none.
Sex: F
Vaccine: HEPA, TYP
Symptoms: Aggression, Bacterial infection, Bacterial test positive, Body temperature increased, Diarrhoea
Clinical narrative: Initial unsolicited report received from a consumer on 31 July 2015. A female patient, whose age, medical history and concomitant medications were not reported, had received a dose of Typhoid vaccine (batch number - K0331, expiry date - 22 July 2016, route and site of administration were not reported) on unspecified date. On unspecified date after vaccination, the patient experienced an adverse reaction (unspecified). Laboratory investigations and corrective treatments were not reported. At the time of this report, the outcome of the event was not reported. Documents held by sender: none.
Sex: F
Vaccine: HEPA, TYP
Symptoms: Hypopnoea, Hypotension, Intensive care
Clinical narrative: Initial unsolicited report received from a consumer on 31 July 2015. A female patient, whose age, medical history and concomitant medications were not reported, had received a dose of Typhoid vaccine (batch number - K0331, expiry date - 22 July 2016, route and site of administration were not reported) on unspecified date. On unspecified date after vaccination, the patient experienced an adverse reaction (unspecified). Laboratory investigations and corrective treatments were not reported. At the time of this report, the outcome of the event was not reported. Documents held by sender: none.
Sex: F
Vaccine: HEPA, TYP
Symptoms: Adverse reaction
Clinical narrative: Initial unsolicited report received from a consumer on 31 July 2015. A female patient, whose age, medical history and concomitant medications were not reported, had received a dose of Typhoid vaccine (batch number - K0331, expiry date - 22 July 2016, route and site of administration were not reported) on unspecified date. On unspecified date after vaccination, the patient experienced an adverse reaction (unspecified). Laboratory investigations and corrective treatments were not reported. At the time of this report, the outcome of the event was not reported. Documents held by sender: none.
Age: 24.0
Sex: F
Vaccine: HEP, HEPA, VARCEL, HEP, HEPA, VARCEL
Symptoms: Exposure during pregnancy, Pregnancy test positive
Clinical narrative: This spontaneous prospective pregnancy report was received from a nurse practitioner and refers to a 24 year old female patient. The patient had no pertinent medical history and no known drug allergies. On 24-AUG-2015, the pregnant patient was administered one dose of VARIVAX (Merck) (dose, route, lot# and expiration date were not reported) from an unspecified healthcare provider. The reason for vaccination was for "an immigration requirement". On 24-AUG-2015, the patient was also administered doses of ENGERIX-B (dose, route, lot# and expiration date were not reported) and HAVRIX (dose, route, lot# and expiration date were not reported). The patient was taking unspecified prenatal vitamins. The patient's pregnancy was confirmed by a serum testing (on an unspecified date). No ultrasounds were performed. The patient's last menstruation period (LMP) date and gestation were unspecified. The estimated delivery date was not known. The pregnancy outcome was pending. The fetal outcome was unknown. No adverse effect reported. There was no hospitalization, no significant disability and no incapacity. Additional information has been requested.
Age: 24.0
Sex: F
Vaccine: HEP, HEPA, VARCEL, HEP, HEPA, VARCEL
Symptoms: Exposure during pregnancy, No adverse event, Pregnancy test positive
Clinical narrative: This spontaneous prospective pregnancy report was received from a nurse practitioner and refers to a 24 year old female patient. The patient had no pertinent medical history and no known drug allergies. On 24-AUG-2015, the pregnant patient was administered one dose of VARIVAX (Merck) (dose, route, lot# and expiration date were not reported) from an unspecified healthcare provider. The reason for vaccination was for "an immigration requirement". On 24-AUG-2015, the patient was also administered doses of ENGERIX-B (dose, route, lot# and expiration date were not reported) and HAVRIX (dose, route, lot# and expiration date were not reported). The patient was taking unspecified prenatal vitamins. The patient's pregnancy was confirmed by a serum testing (on an unspecified date). No ultrasounds were performed. The patient's last menstruation period (LMP) date and gestation were unspecified. The estimated delivery date was not known. The pregnancy outcome was pending. The fetal outcome was unknown. No adverse effect reported. There was no hospitalization, no significant disability and no incapacity. Additional information has been requested.
Age: 64.0
Sex: F
Vaccine: VARZOS
Symptoms: Burning sensation, Feeling abnormal, Pruritus generalised
Clinical narrative: A few hours after the shot I went to the bathroom and had a bowel movement and peeded.  An instant burning from front to back occurred.  Water made the burning worse so I used A&D ointment for the next 24 hour period.  Within a few days I had the feeling I was moving in slow motion but my husband assured me I wasn't.  This lasted for maybe one to two weeks.  Ever since I received the vaccine for shingles, my skin, especially on portions of my back constantly itch as well as certain parts of my head, abdomen, arms, legs.  These weren't listed as any side effects but I have these problems now and it wasn't a problem before the shot.  The burning was a 24 hour thing.
Sex: F
Vaccine: HPV4
Symptoms: Paraplegia
Clinical narrative: This spontaneous report was received from a physician via company representative refers to an unspecified child female patient of unknown age. The patient's medical history, concurrent conditions and concomitant medications were not reported. It was reported that unspecified mother of a child stated to the physician that she did not want to give her child the GARDASIL, because her friends neighbor's daughter was vaccinated (date unspecified) with the dose of GARDASIL injection (dose, route of administration, lot# and expiration date were not reported) and became paraplegic (details unspecified). The physician said the mother informed him that this was described in the newspapers (unspecified). The outcome of the adverse event and the causality between the adverse event and GARDASIL were not provided. Upon internal review, paraplegia was considered to be disabling. Is not expected as there was no consent for the follow-up.
Age: 30.0
Sex: F
Vaccine: HIBV, PPV
Symptoms: Dizziness, Heart rate increased, Muscular weakness, Pain in extremity, Peripheral swelling
Clinical narrative: Patient reported dizziness, fast heartbeat, weakness, and pain and swelling in left arm.
Age: 71.0
Sex: F
Vaccine: FLU3, PNC13
Symptoms: Local reaction
Clinical narrative: Pt developed 2-3 inch localized reaction. Hx of (L) mastectomy/lymphedema, pt had both PCV 13 & flu in (R) deltoid. Denies fever. Ice compress el/ibuprofen-issue is resolving.
Age: 0.54
Sex: F
Vaccine: DTAPIPVHIB, PNC13
Symptoms: Injection site erythema, Pyrexia
Clinical narrative: Fever, slightly pink area to injection sites (no induration or warmth).