chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 35.0
Sex: F
Vaccine: HEP
Symptoms: Drug administered at inappropriate site, Incorrect route of drug administration, Injection site erythema, Injection site swelling, Wrong drug administered
Clinical narrative: This case was reported by a healthcare professional (nurse practitioner) and described the occurrence of injection site redness in a 35-year-old female subject who was vaccinated with ENGERIX B (GlaxoSmithKline). On 19 July 2013 the subject received unspecified dose of ENGERIX B (.1 ml, intradermal, right forearm) and experienced inappropriate route of vaccination, vaccine administered at inappropriate site and wrong vaccine administered. The subject was mistakenly administered ENGERIX B intradermally instead of as an intramuscular injection in the right forearm. ENGERIX B is indicated to be administered in the deltoid arm muscle. The subject should have received an annual PPD test at her employee health clinic, however she was mistakenly administered ENGERIX B. In July 2013, less than one month after vaccination with ENGERIX B, the subject experienced injection site redness and raised area injection site. According to the nurse practitioner, the subject "is experiencing an injection site reaction after receiving ENGERIX B intradermally and the site is red and raised and 1 cm in diameter". The nurse practitioner prescribed a topical corticosteroid for treatment. At the time of reporting the events were unresolved. Follow up was received from the healthcare professional on 3 September 2013. The healthcare professional documented that the events could have been associated with erroneous administration. The reporter stated that "staff at the work site should have administered PPD but ENGERIX B was given intradermally instead." No action was taken with ENGERIX B.
Sex: F
Vaccine: HEP
Symptoms: Headache, Immediate post-injection reaction
Clinical narrative: This case was reported by a healthcare professional (nurse) and described the occurrence of headache in a female subject of unspecified age who was vaccinated with ENGERIX B (GlaxoSmithKline). On an unspecified date the subject received 2nd dose of ENGERIX B (unknown details). Immediately after vaccination with ENGERIX B, the subject experienced headache. At the time of reporting the event was resolved. Per the nurse, the event "lasted 4 days."
Sex: U
Vaccine: HPV4
Symptoms: Unevaluable event
Clinical narrative: Information has been received from the registered nurse on 02-JAN-2014. It was reported that GARDASIL was administered to overall number of 132 patients. This report refers to one of the patients involved: a patient of unspecified age and gender, who had administered dose of GARDASIL on 21-FEB-2013 (lot # and expiration date were not reported). This is one of the report from the same source, linked reports. Additional information is not expected.
Sex: F
Vaccine: HPV4
Symptoms: Inappropriate schedule of drug administration, No adverse event
Clinical narrative: This spontaneous report as received from a medical assistant refers to a patient of unknown age. Medical assistant reported that the patient received first and second dose (dosing information, route of administration and lot number were not provided) of GARDASIL "3 years ago) (approximately 2010/2011) and received third dose (dosing information, route of administration and lot number were not provided) today, on 13-JAN-2014. No adverse effects were reported. Additional information has been requested.
Age: 63.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site erythema, Injection site pruritus
Clinical narrative: Information has been received from a pharmacist regarding a 63 year old female patient. There was no medical history, drug reactions or allergies. On 10-JAN-2014, the patient was vaccinated with a single dose of ZOSTAVAX (subcutaneous in the left arm) (lot # J001700, expiration date 08-MAY-2014). On 11-JAN-2014, the patient developed redness and itching at the injection site. The area of reaction involved the whole back of the left arm. The patient did not receive treatment for the adverse events. The patient sought medical attention, called the pharmacy. Laboratory test was not performed. At the time of the report, the patient had not recovered from the adverse events. Additional information has been requested.
Age: 48.0
Sex: F
Vaccine: FLUC3
Symptoms: Hypoaesthesia, Migraine
Clinical narrative: After receiving her flu shot the patient started having left side facial numbness, migraine headaches and right foot numbness.
Age: 31.0
Sex: F
Vaccine: FLU3, RAB, TYP
Symptoms: Fatigue, Headache, Pruritus, Rash, Vomiting
Clinical narrative: Fatigue, emesis, pruritus, headache and rash within 48 hours of vaccine. Visit office Jan 7, 2014 given, Z-PAK, B-12, TORADOL with no relief of symptoms. Visit MC Jan 9, 14 given BENADRYL and sent home x 2 days. Jan 13 follow up and symptoms much improved.
Age: 2.0
Sex: F
Vaccine: FLU3
Symptoms: Blood glucose normal, Foaming at mouth, Postictal state, Unresponsive to stimuli
Clinical narrative: Pt. was given a flu vaccine (pt previously received 3 doses in life). After discharged, pt was brought back by family d/t pt. was unresponsive, foaming in the mouth and in a postictal state. Pt. was taken to ED then followed up in the clinic the following day.
Age: 34.0
Sex: F
Vaccine: FLUN4, FLUN4
Symptoms: Exposure during pregnancy
Clinical narrative: Above client is 9 wks pregnant and received FLUMIST.
Age: 11.0
Sex: M
Vaccine: MNQ, TDAP, VARCEL
Symptoms: Dyspnoea, Erythema, Nausea, Pyrexia, Skin warm
Clinical narrative: Low grade fever, nausea, felt short of breath, area very swollen, warm, red. All started 12-24 hrs after imm.
Age: 11.0
Sex: M
Vaccine: MNQ, TDAP, VARCEL
Symptoms: Swelling
Clinical narrative: Low grade fever, nausea, felt short of breath, area very swollen, warm, red. All started 12-24 hrs after imm.
Age: 10.0
Sex: F
Vaccine: FLUC3
Symptoms: Erythema, Injection site pain, Rash, Swelling
Clinical narrative: Swelling and redness on forearm and left hand of injected left arm with small bumps. Pain at injection site.
Age: 9.0
Sex: F
Vaccine: HPV4
Symptoms: Chest X-ray, Chest discomfort, Chest pain, Electrocardiogram normal, Exercise tolerance decreased
Clinical narrative: Pt reports chest pain (pressure in the chest) since the day of the vaccine. Pt cannot tolerate running because the activity triggers chest pain. Prior to vaccine child was asymptomatic.
Age: 9.0
Sex: M
Vaccine: HPV4
Symptoms: Computerised tomogram head normal, Fall, Haematoma, Head injury, Joint injury
Clinical narrative: Child had vasovagal response after administration of GARDASIL vaccine - fell and struck parietal area of skull and right wrist. CT of skull showed right posterior parietal scalp hematoma 15 mm in thickness with transverse diameter of 6.5 mm. X-ray arm negative. Also developed vomiting.
Age: 9.0
Sex: M
Vaccine: HPV4
Symptoms: Presyncope, Vomiting, X-ray limb normal
Clinical narrative: Child had vasovagal response after administration of GARDASIL vaccine - fell and struck parietal area of skull and right wrist. CT of skull showed right posterior parietal scalp hematoma 15 mm in thickness with transverse diameter of 6.5 mm. X-ray arm negative. Also developed vomiting.
Age: 17.0
Sex: M
Vaccine: FLU3, HPV4
Symptoms: Blood pressure decreased, Dizziness, Hypoacusis
Clinical narrative: Dizziness, decreased hearing, decreased blood pressure while leaving building soon after vaccine administration.
Age: 29.0
Sex: F
Vaccine: FLU3
Symptoms: Dizziness, Hypoaesthesia, Local swelling, Pain in extremity, Paraesthesia
Clinical narrative: Swelling in left ring finger w/ rash. Swelling and pain through left arm. Lightheadedness, swelling sensation in tongue/throat. Tingling and numbness in left hand. Pain in hand. Steroid/antihistamine/ibuprofen/sleep aid.
Age: 29.0
Sex: F
Vaccine: FLU3
Symptoms: Pharyngeal oedema, Rash, Swollen tongue
Clinical narrative: Swelling in left ring finger w/ rash. Swelling and pain through left arm. Lightheadedness, swelling sensation in tongue/throat. Tingling and numbness in left hand. Pain in hand. Steroid/antihistamine/ibuprofen/sleep aid.
Age: 58.0
Sex: F
Vaccine: FLU3
Symptoms: Erythema, Pruritus, Urticaria
Clinical narrative: Her arm itched as it does every year, but this time - 4 days after the immunization, her arm had a huge red welt from shoulder to elbow. It resolved with Hydrocortisone cream.
Age: 60.0
Sex: M
Vaccine: VARCEL
Symptoms: Anaphylactic reaction, Angioedema
Clinical narrative: Anaphylaxis and angioedema.
Sex: M
Vaccine: HPV4
Symptoms: Haemorrhage
Clinical narrative: This spontaneous report as received from a consumer refers to her son, a male patient of unknown age. No medical history or concurrent conditions were reported. On an unknown date the patient was vaccinated with the first shot of GARDASIL. No concomitant medication was reported. The reporter stated that after receiving his first shot of GARDASIL he experienced (unspecified) bleeding. The reporter added that her son still has not yet received the 2nd or 3rd dose of GARDASIL and was not vaccinated with the recalled batch of the vaccine. The outcome of bleeding is unknown. The reporter did not provide a causality statement. No further information was provided. Additional information is not expected.
Age: 26.0
Sex: F
Vaccine: FLU3, PPV
Symptoms: Acute respiratory failure, Coma, Condition aggravated, Death, Diabetic ketoacidosis
Clinical narrative: Information was received regarding a case in litigation concerning a 26 year old female who suffered from Type 1, Juvenile Diabetes for the majority of her lifetime. On or about 13-DEC-2011, the patient was admitted to the hospital with a diagnosis of uncontrolled diabetes mellitus with ketoacidosis (DKA). The patient was treated with an insulin drip and met with a dietician while in the hospital. On 14-DEC-2011, while preparing for discharge, the patient was administered PNEUMOVAX23 and FLUZONE. The patient began experiencing shortness of breath on 18-DEC-2011 and was taken to hospital via ambulance. At the hospital the patient was diagnosed with pneumonia, acute respiratory failure and diabetic ketoacidosis (DKA). The patient was orally intubated and mechanically ventilated. Shortly after admission, the patient went into acute respiratory distress and became septic. The patient fell into a coma for approximately one month. The patient was hospitalized for a total of two months and was discharged on or about 09-FEB-2012. The patient never fully recovered from this hospitalization and spent the remainder of her life in and out of hospitals. The patient passed away on 02-NOV-2013 as a result of pneumonia. The patient suffered pneumonia, sepsis, respiratory distress/failure, coma and death which were a direct and proximate result of PNEUMOVAX23 and FLUZONE vaccinations. Upon internal review, coma, sepsis, and diabetic ketoacidosis were determined to be medically significant events. Additional information has been requested.
Age: 26.0
Sex: F
Vaccine: FLU3, PPV
Symptoms: Dyspnoea, Endotracheal intubation, Mechanical ventilation, Pneumonia, Respiratory distress
Clinical narrative: Information was received regarding a case in litigation concerning a 26 year old female who suffered from Type 1, Juvenile Diabetes for the majority of her lifetime. On or about 13-DEC-2011, the patient was admitted to the hospital with a diagnosis of uncontrolled diabetes mellitus with ketoacidosis (DKA). The patient was treated with an insulin drip and met with a dietician while in the hospital. On 14-DEC-2011, while preparing for discharge, the patient was administered PNEUMOVAX23 and FLUZONE. The patient began experiencing shortness of breath on 18-DEC-2011 and was taken to hospital via ambulance. At the hospital the patient was diagnosed with pneumonia, acute respiratory failure and diabetic ketoacidosis (DKA). The patient was orally intubated and mechanically ventilated. Shortly after admission, the patient went into acute respiratory distress and became septic. The patient fell into a coma for approximately one month. The patient was hospitalized for a total of two months and was discharged on or about 09-FEB-2012. The patient never fully recovered from this hospitalization and spent the remainder of her life in and out of hospitals. The patient passed away on 02-NOV-2013 as a result of pneumonia. The patient suffered pneumonia, sepsis, respiratory distress/failure, coma and death which were a direct and proximate result of PNEUMOVAX23 and FLUZONE vaccinations. Upon internal review, coma, sepsis, and diabetic ketoacidosis were determined to be medically significant events. Additional information has been requested.
Age: 26.0
Sex: F
Vaccine: FLU3, PPV
Symptoms: Sepsis
Clinical narrative: Information was received regarding a case in litigation concerning a 26 year old female who suffered from Type 1, Juvenile Diabetes for the majority of her lifetime. On or about 13-DEC-2011, the patient was admitted to the hospital with a diagnosis of uncontrolled diabetes mellitus with ketoacidosis (DKA). The patient was treated with an insulin drip and met with a dietician while in the hospital. On 14-DEC-2011, while preparing for discharge, the patient was administered PNEUMOVAX23 and FLUZONE. The patient began experiencing shortness of breath on 18-DEC-2011 and was taken to hospital via ambulance. At the hospital the patient was diagnosed with pneumonia, acute respiratory failure and diabetic ketoacidosis (DKA). The patient was orally intubated and mechanically ventilated. Shortly after admission, the patient went into acute respiratory distress and became septic. The patient fell into a coma for approximately one month. The patient was hospitalized for a total of two months and was discharged on or about 09-FEB-2012. The patient never fully recovered from this hospitalization and spent the remainder of her life in and out of hospitals. The patient passed away on 02-NOV-2013 as a result of pneumonia. The patient suffered pneumonia, sepsis, respiratory distress/failure, coma and death which were a direct and proximate result of PNEUMOVAX23 and FLUZONE vaccinations. Upon internal review, coma, sepsis, and diabetic ketoacidosis were determined to be medically significant events. Additional information has been requested.
Age: 13.0
Sex: M
Vaccine: FLUC3
Symptoms: Drug administered to patient of inappropriate age
Clinical narrative: Flucelvax given to person under 18, not currently approved for lower than 18.
Age: 71.0
Sex: F
Vaccine: FLU4
Symptoms: Injection site bruising, Injection site reaction, Rash erythematous, Rash pruritic
Clinical narrative: Developed 1 inch diam bruise at injection site on left arm;  red raised itchy rash on both upper arms shoulder to elbow.  No treatment.
Age: 6.0
Sex: M
Vaccine: FLU3
Symptoms: Condition aggravated, Convulsion
Clinical narrative: Seizure activity started the day after vaccine, he was seizure free for over a yr on a low dose of Keppra 150mg/day now at 600mg twice daily with 160 seizures since vaccine administration.
Age: 34.0
Sex: M
Vaccine: FLU3
Symptoms: Abdominal pain upper, Lethargy, Muscle spasms, Urticaria
Clinical narrative: Monday - Moderately severe lethargy and muscle cramping. Slept 18 hours and drank only liquids. Tuesday - Lethargy gone, slight stomach cramping remained. Onset of hives. Today (Wednesday) - No cramping or lethargy, hives worsening to moderate.
Age: 2.0
Sex: M
Vaccine: FLUN4
Symptoms: Heart rate increased, Pain, Pyrexia, Sleep disorder
Clinical narrative: HIS FEVER BEGAN THAT EVENING HE WAS GIVEN THE NASAL VACCINE. I GAVE HIM CHILDRENS ADVIL AND IT WORKED. ON THE NIGHT OF 1/14 HIS FEVER GOT UP TO 102.0F AND HE WAS UNABLE TO SLEEP BECAUSE HIS BODY ACHED AND HE WAS SO HOT AND HIS HEART BEATING VERY FAST. I AGAIN GAVE HIM CHILDRENS ADVIL AND AN HOUR LATER HIS FEVER WENT DOWN BUT STILL HOT AND UNABLE TO SLEEP.
Age: 0.7
Sex: M
Vaccine: HIBV
Symptoms: Blood test, Crying, Electroencephalogram, Gene mutation identification test, Infantile spasms
Clinical narrative: The child was vomiting crying and started having later what was diagnosed as infantile spasms.
Age: 0.7
Sex: M
Vaccine: HIBV
Symptoms: Nuclear magnetic resonance imaging, Vomiting
Clinical narrative: The child was vomiting crying and started having later what was diagnosed as infantile spasms.
Age: 12.0
Sex: F
Vaccine: HPV4, TTOX
Symptoms: Retinal haemorrhage, Uveitis, Vitreous floaters
Clinical narrative: Information has been received from a literature article concerning a 12 year old female patient developed uveitis, retinal hemorrhage and vitreous floaters following administration of GARDASIL and tetanus toxoid vaccine. A total of 24 cases of uveitis occurred following administration of GARDASIL; the gender in all cases was female. The median age was 17 (range 12-29). The median time from vaccination to onset of ADRs was 30 days (range 0-476); time to onset was unknown in 1 case; the time to onset in this case was of 58 days from vaccination. There was one reported rechallenged of the GARDASIL vaccine. In 13 of the 24 cases other ocular side effects were noted including 3 case reports of papillitis, 2 case reports of retinitis and 1 case report of papilledema. Systemic side effects were noted in 9 of the 24 cases and included 3 cases of arthralgia. In 2 case reports multiple vaccines were administered simultaneously. According to World Health Organization Causality Assessment Guide of Suspected Adverse Reactions, the relationship between human papilloma virus vaccine and uveitis was "possible". Causality assessments are based on the time relationship of drug administration, uveitis development and rechallenge data. This is one of several reports from the same literature source. Additional information has been requested.
Age: 17.0
Sex: F
Vaccine: HPV4
Symptoms: Uveitis
Clinical narrative: Information has been received from a literature article concerning a 17 year old female patient developed uveitis following administration of GARDASIL. A total of 24 cases of uveitis occurred following administration of GARDASIL; the gender in all cases was female. The median age was 17 (range 12-29). The median time from vaccination to onset of ADRs was 30 days (range 0-476); time to onset was unknown in this case; the time to onset in this case was 7 days from vaccination. There was one reported rechallenged of the GARDASIL vaccine. In 13 of the 24 cases other ocular side effects were noted including 3 case reports of papillitis, 2 case reports of retinitis and 1 case report of papilledema. Systemic side effects were noted in 9 of the 24 cases and included 2 cases of arthralgia. In 2 case reports multiple vaccines were administered simultaneously. According to World Health Organization Causality Assessment Guide of Suspected Adverse Reactions, the relationship between human papilloma virus vaccine and uveitis was "possible". Causality assessments are based on the time relationship of drug administration, uveitis development and rechallenge data. This is one of several reports from the same literature source. Additional information has been requested.
Age: 17.0
Sex: F
Vaccine: HPV4
Symptoms: Corneal deposits, Eye naevus, Macular oedema, Uveitis
Clinical narrative: Information has been received from a literature article concerning a 17 year old female patient developed uveitis, corneal deposits, choroidal nevus and macula edema following administration of GARDASIL. A total of 24 cases of uveitis occurred following administration of GARDASIL; the gender in all cases was female. The median age was 17 (range 12-29). The median time from vaccination to onset of ADRs was 30 days (range 0-476); time to onset was unknown in this case; the time to onset in this case was 7 days from vaccination. There was one reported rechallenged of the GARDASIL vaccine. In 13 of the 24 cases other ocular side effects were noted including 3 case reports of papillitis, 2 case reports of retinitis and 1 case report of papilledema. Systemic side effects were noted in 9 of the 24 cases and included 3 cases of arthralgia. In 2 case reports multiple vaccines were administered simultaneously. According to World Health Organization Causality Assessment Guide of Suspected Adverse Reactions, the relationship between human papilloma virus vaccine and uveitis was "possible". Causality assessments are based on the time relationship of drug administration, uveitis development and rechallenge data. This is one of several reports from the same literature source. Additional information has been requested.
Age: 16.0
Sex: F
Vaccine: HPV4
Symptoms: Uveitis
Clinical narrative: Information has been received from a literature article concerning a 16 year old female patient developed uveitis following administration of GARDASIL. A total of 24 cases of uveitis occurred following administration of GARDASIL; the gender in all cases was female. The median age was 17 (range 12-29). The median time from vaccination to onset of ADRs was 30 days (range 0-476); time to onset was unknown in this case; the time to onset in this case was of 14 days from vaccination. There was one reported rechallenged of the GARDASIL vaccine. In 13 of the 24 cases other ocular side effects were noted including 3 case reports of papillitis, 2 case reports of retinitis and 1 case report of papilledema. Systemic side effects were noted in 9 of the 24 cases and included 3 cases of arthralgia. In 2 case reports multiple vaccines were administered simultaneously. According to World Health Organization Causality Assessment Guide of Suspected Adverse Reactions, the relationship between human papilloma virus vaccine and uveitis was "possible". Causality assessments are based on the time relationship of drug administration, uveitis development and rechallenge data. This is one of several reports from the same literature source. Additional information has been requested.
Age: 68.0
Sex: F
Vaccine: FLU3, TDAP
Symptoms: Erythema
Clinical narrative: Reaction to vaccine. Pt had a tetanus shot in the office on the 8th of this month and thinks she having a reaction to the shot. Redness started on Sunday 3 days after the shot. Pt has some redness on her arm. No fever, no chills and no real pain. No numbness or tingling.
Age: 9.0
Sex: M
Vaccine: TDAP
Symptoms: Rash erythematous, Tenderness
Clinical narrative: He presented with a rash. It was located on the left arm. It was described as acute. The color was erythematous. The symptoms started a few days ago. The complaint is moderate. Previously treated with BENADRYL. Important triggers include certain medications site of Tdap vaccine last week. Patient denies dizziness, fatigue, fever. Associated signs and symptoms include tenderness. Mom to start using CORTIZONE cream and liquid BENADRYL and RTC STAT for worsening.
Age: 56.0
Sex: M
Vaccine: FLUC3, TDAP, FLUC3, TDAP
Symptoms: Chills, Influenza like illness, Nausea, Pyrexia, Vomiting
Clinical narrative: This case was reported by a pharmacist and described the occurrence of flu like symptoms in a 56-year-old male subject who was vaccinated with BOOSTRIX (GlaxoSmithKline). Co-suspect vaccination included FLUCELVAX (Novartis, unknown). On 5 January 2014 at at approximately 13:00-14:00, the subject received a dose of BOOSTRIX (.5 ml, unknown) and FLUCELVAX (non-GSK); Novartis. On 5 January 2014 at approximately 19:00-20:00, 6 hours after vaccination with BOOSTRIX and FLUCELVAX, the subject experienced flu like symptoms, nausea, vomiting, fever and chills. A pharmacist reported a subject had flu like symptoms following BOOSTRIX and FLUCELVAX vaccinations. The pharmacist did not specifically mention the flu vaccine as a possible cause for the symptoms, it was only named as a concomitant vaccination. The pharmacist considered the events were disabling. At the time of reporting the flu like symptoms, nausea, vomiting, fever and chills were unresolved. The pharmacist considered the events were probably related to vaccination with BOOSTRIX.
Age: 21.0
Sex: F
Vaccine: HPV4
Symptoms: Arthralgia, Papillitis, Papilloedema, Retinitis, Uveitis
Clinical narrative: Information has been received from a literature article concerning a 21 year old female patient developed uveitis following administration of GARDASIL. The patient had as a pre-existing conditions Crohn's flare and arthralgia. A total of 24 cases of uveitis occurred following administration of GARDASIL; the gender in all cases was female. The median age was 17 (range 12-29). The median time from vaccination to onset of ADRs was 30 days (range 0-476); time to onset was unknown in 1 case; the time to onset in this case was of 0 days from vaccination. There was one reported rechallenged of the GARDASIL vaccine. In 13 of the 24 cases other ocular side effects were noted including 3 case reports of papillitis, 2 case reports of retinitis and 1 case report of papilledema. Systemic side effects were noted in 9 of the 24 cases and included 3 cases of arthralgia. In 2 case reports multiple vaccines were administered simultaneously. According to World Health Organization Causality Assessment Guide of Suspected Adverse Reactions, the relationship between human papilloma virus vaccine and uveitis was "possible". Causality assessments are based on the time relationship of drug administration, uveitis development and rechallenge data. This is one of several reports from the same literature source. Additional information has been requested.
Age: 42.0
Sex: M
Vaccine: FLU4
Symptoms: Convulsion, Fatigue, Myalgia, Pain, Partial seizures
Clinical narrative: This case was reported by a consumer's spouse and described the occurrence of seizure in a 42-year-old male subject who was vaccinated FLUARIX TRIVALENT or QUADRIVALENT (GlaxoSmithKline), influenza virus vaccine (unspecified). A physician or other health care professional has not verified this report. On 6 January 2014 at 12:00 the subject received a dose of FLUARIX TRIVALENT or QUADRIVALENT (unknown, left deltoid). On 6 January 2014, 3 hours after vaccination with FLUARIX, the subject experienced seizure, fatigue, muscle soreness, body pain, and partial seizure on side. The subject's wife reported that her husband experienced a mild "paraseizure" after being administered the FLUARIX vaccine. She was unsure if the vaccine was trivalent or quadrivalent. The subject's "symptoms originated in his left cheek and extend dose his left arm, mostly in his left thumb and fore fingers". The subject took ibuprofen following FLUARIX vaccination. At the time of the report all his symptoms have remained the same. This case was assessed as medically serious by GSK. At the time of reporting the outcome of the seizure, fatigue, muscle soreness and body pain were unresolved. The spouse also reported that the subject experienced "nothing beyond soreness at the site" with previous flu shots; vaccination dates and details regarding the injection site soreness were not provided. The outcome of the injection site soreness was unspecified.
Age: 38.0
Sex: F
Vaccine: HEP
Symptoms: Biopsy liver, Hepatitis B antibody negative, Lymphadenopathy, No therapeutic response, Positron emission tomogram
Clinical narrative: This case was reported by a healthcare professional (nurse) who is also the patient and described the occurrence of abdominal lymph nodes enlarged in a 38-year-old female subject who was vaccinated with ENGERIX B (GlaxoSmithKline). Concurrent medical conditions included allergy to soy. Concurrent medications included ACIPHEX. In either 2006 or 2007 the subject received unspecified dose of ENGERIX B (unknown). On 31 October 2013, six or seven years after vaccination with ENGERIX B, the subject experienced not responding to therapy. The subject did not develop hepatitis B antibodies when she received the vaccine while in nursing school, she was tested on 31 October 2013. At an unspecified time after vaccination with ENGERIX B, the subject experienced abdominal lymph nodes enlarged and liver biopsy. She reported that she now has enlarged lymph nodes in her abdomen, received three liver biopsies, two PET (Positron emission tomography) scans and an esophageal ultrasound. No other details were provided included the relevant test results. The subject was hospitalized, details not provided. At the time of reporting the outcome of the not responding to therapy, abdominal lymph nodes enlarged and liver biopsy were unspecified.
Age: 38.0
Sex: F
Vaccine: HEP
Symptoms: Ultrasound scan
Clinical narrative: This case was reported by a healthcare professional (nurse) who is also the patient and described the occurrence of abdominal lymph nodes enlarged in a 38-year-old female subject who was vaccinated with ENGERIX B (GlaxoSmithKline). Concurrent medical conditions included allergy to soy. Concurrent medications included ACIPHEX. In either 2006 or 2007 the subject received unspecified dose of ENGERIX B (unknown). On 31 October 2013, six or seven years after vaccination with ENGERIX B, the subject experienced not responding to therapy. The subject did not develop hepatitis B antibodies when she received the vaccine while in nursing school, she was tested on 31 October 2013. At an unspecified time after vaccination with ENGERIX B, the subject experienced abdominal lymph nodes enlarged and liver biopsy. She reported that she now has enlarged lymph nodes in her abdomen, received three liver biopsies, two PET (Positron emission tomography) scans and an esophageal ultrasound. No other details were provided included the relevant test results. The subject was hospitalized, details not provided. At the time of reporting the outcome of the not responding to therapy, abdominal lymph nodes enlarged and liver biopsy were unspecified.
Age: 26.0
Sex: M
Vaccine: TDAP
Symptoms: Erythema, Feeling hot, Swelling
Clinical narrative: Red and hot and swollen.
Age: 29.0
Sex: F
Vaccine: HPV4
Symptoms: Uveitis
Clinical narrative: Information has been received from a literature article concerning a 29 year old female patient developed uveitis, following administration of GARDASIL. The patient had as a pre-existing conditions Behcets and pericarditis. A total of 24 cases of uveitis occurred following administration of GARDASIL; the gender in all cases was female. The median age was 17 (range 12-29). The median time from vaccination to onset of ADRs was 30 days (range 0-476); time to onset was unknown in 1 case; the time to onset in this case was of 30 days from vaccination. There was one reported rechallenged of the GARDASIL vaccine. In 13 of the 24 cases other ocular side effects were noted including 3 case reports of papillitis, 2 case reports of retinitis and 1 case report of papilledema. Systemic side effects were noted in 9 of the 24 cases and included 3 cases of arthralgia. In 2 case reports multiple vaccines were administered simultaneously. The ocular findings of papilledema and papillitis may be confounded by pre-existing conditions (sarcoidosis, cat scratch disease and Behcet's disease) known to affect the optic nerve in 3 case reports. According to World Health Organization Causality Assessment Guide of Suspected Adverse Reactions, the relationship between human papilloma virus vaccine and uveitis was "possible". Causality assessments are based on the time relationship of drug administration, uveitis development and rechallenge data. This is one of several reports from the same literature source. Additional information has been requested.
Age: 18.0
Sex: F
Vaccine: HPV4
Symptoms: Uveitis
Clinical narrative: Information has been received from a literature article concerning a 18 year old female patient developed uveitis, following administration of GARDASIL. A total of 24 cases of uveitis occurred following administration of GARDASIL; the gender in all cases was female. The median age was 17. The median time from vaccination to onset of ADRs was 30 days; time to onset was unknown in 1 case; the time to onset in this case was of 117 days from vaccination. There was one reported rechallenge of the GARDASIL vaccine. In 13 of the 24 cases other ocular side effects were noted including 3 case reports of papillitis, 2 case reports of retinitis and 1 case report of papilledema. Systemic side effects were noted in 9 of the 24 cases and included 3 cases of arthralgia. In 2 case reports multiple vaccines were administered simultaneously. According to World Health Organization Causality Assessment Guide of Suspected Adverse Reactions, the relationship between human papilloma virus vaccination and uveitis was "possible". Causality assessments are based on the time relationship of drug administration, uveitis development and rechallenge data. This is one of several reports form the same literature source. Additional information has been requested.
Age: 18.0
Sex: M
Vaccine: HPV4
Symptoms: Aspartate aminotransferase increased, Back pain, C-reactive protein increased, Chest pain, Electrocardiogram ST segment elevation
Clinical narrative: Vaccine 12-19-13. 12-21 nausea and pain to chest. 12-22 severe chest pain radiating to back, neck. Went to hospital: abn EKG - pericarditis, abn labs Troponin and Myoglobin and WBC elevated, SGOT 4.3, CRP 2.8, EKG - ST elevation.
Age: 18.0
Sex: M
Vaccine: HPV4
Symptoms: Myoglobin blood increased, Nausea, Neck pain, Pericarditis, Troponin increased
Clinical narrative: Vaccine 12-19-13. 12-21 nausea and pain to chest. 12-22 severe chest pain radiating to back, neck. Went to hospital: abn EKG - pericarditis, abn labs Troponin and Myoglobin and WBC elevated, SGOT 4.3, CRP 2.8, EKG - ST elevation.
Age: 18.0
Sex: M
Vaccine: HPV4
Symptoms: White blood cell count increased
Clinical narrative: Vaccine 12-19-13. 12-21 nausea and pain to chest. 12-22 severe chest pain radiating to back, neck. Went to hospital: abn EKG - pericarditis, abn labs Troponin and Myoglobin and WBC elevated, SGOT 4.3, CRP 2.8, EKG - ST elevation.
Age: 19.0
Sex: F
Vaccine: HPV4, MMR, VARZOS
Symptoms: Intraocular pressure increased, Retinitis, Uveitis, Vitritis
Clinical narrative: Information has been received from a literature article concerning a 19 year old female patient developed uveitis, elevated intraocular pressure (IOP), retinitis and vitritis, following administration of GARDASIL, ZOSTAVAX and M-M-R II. The patient had as a pre-existing conditions cat scratch disease. A total of 24 cases of uveitis occurred following administration of GARDASIL; the gender in all cases was female. The median age was 17 (range 12-29). The median time from vaccination to onset of ADRs was 113 days (range 0-476 days); time to onset was unknown in 1 case; the time to onset in this case was of 0 days from vaccination. There was one reported rechallenge of the GARDASIL vaccine. In 13 of the 24 cases other ocular side effects were noted including 3 case reports of papillitis, 2 case reports of retinitis and 1 case report of papilledema. Systemic side effects were noted in 9 of the 24 cases and included 3 cases of arthralgia. In 2 case reports multiple vaccines were administered simultaneously. Uveitis following vaccination has been previously reported. ZOSTAVAX has been associated with both exacerbation of preexisting uveitis and de novo cases. Two cases of acute retinal necrosis associated with varicella vaccination have been reported. It is unclear whether the etiology of uveitis was related to inoculum with live attenuated varicella viral particles or whether it was caused by resurgence of preexisting dormant varicella virus. In most cases the uveitis followed a clinical course similar to typical cases of herpes zoster ophthalmicus. This was in contradistinction with other case reports of MMR vaccination and uveitis where the uveitis was limited to a delayed anterior chamber reaction. The possibility that other vaccines which were simultaneously administered in two cases cannot be excluded as the cause of uveitis. According to World Health Organization Causality Assessment Guide of Suspected Adverse Reactions, the relationship between human papilloma virus vaccination and uveitis was "possible". Causality assessments are based on the time relationship of drug administration, uveitis development and rechallenge data. This is one of several reports from the same literature source. Additional information has been requested.
Age: 62.0
Sex: M
Vaccine: PPV
Symptoms: Chills
Clinical narrative: This spontaneous report as received from a pharmacist refers to her father, 62 year old male patient with hypertension. In summer 2013 the patient was vaccinated with PPV (manufacturer unknown) (lot # not reported) dose and frequency not reported. No concomitant therapy was reported. The pharmacist stated that her father received an unspecified PPV (manufacturer unknown) and after receiving the PPV (manufacturer unknown) in 2013, her father experienced severe chills and was taken to an unspecified emergency room. Her father was not admitted to the hospital and after an unspecified treatment, her father was discharged from the emergency room on an unspecified date. The outcome of her father experienced severe chills was reported as recovered/resolved. Additional information has been requested.
Age: 46.0
Sex: M
Vaccine: FLU3
Symptoms: Injection site pain, Pain
Clinical narrative: Left shoulder pain with injection. Pain with horizontal movement of arm shortly after injection. PCP tx with Prednisone 10/2013. 1/13/14 Tx with CELEBREX. Recommend PT.
Age: 13.0
Sex: F
Vaccine: FLUC3
Symptoms: Drug administered to patient of inappropriate age, No adverse event
Clinical narrative: Flucelvax was administered to a 13 years old. No adverse reactions.
Age: 1.1
Sex: F
Vaccine: HEPA
Symptoms: Injection site erythema, Injection site swelling, Pyrexia
Clinical narrative: Quarter size redness and swelling around injections site and fever.
Age: 5.0
Sex: F
Vaccine: DTAPIPV, MMR, VARCEL
Symptoms: Wrong technique in drug usage process
Clinical narrative: MMR and Varicella Immunizations erroneously diluted with 0.9 Normal Saline not sterile water.
Age: 4.0
Sex: M
Vaccine: DTAPIPV, MMR
Symptoms: Cellulitis, Erythema, Local reaction, Local swelling, Swelling face
Clinical narrative: 1/9/2014-Mother called me; states child's arm started swelling and was red about 3 hrs after vaccines given; child was scratching at arm; denied difficulty breathing, stated child was playing normally. I told her to apply cool or warm compresses, give Tylenol or Motrin, monitor child and if no better or gets worse, to see MD. I phoned her at about 9:30 am next morning (1/10/14), she had client in ER because he had woken up with face, ears and under chin swollen; still no difficulty breathing. States she gave him 2 doses Benadryl on 1/9/14 in the afternoon sometime and last dose at 9pm, along with Tylenol and Motrin. States ER gave him some Keflex and steroid by mouth; she was unsure if they gave him Benadryl, but they had asked her if she had given him any. States they were going to monitor him at that time. I followed up again on 1/13/14, states the ER monitored him for a couple hours and sent him home with Keflex BID for 10 days and orders for cool compresses, Tylenol, Motrin, and to follow up with his MD in 2 weeks. His arm was still red and still had some swelling at the time of call on 1/13. I followed up again yesterday (1/14) and the swelling had gone down some. I followed up again today (phone call 1/15) and she states everything is resolved and he is still taking Keflex. I have reports from ER visit that were faxed to me-Diagnosis Localized reaction to immunizations and secondary cellulitis.
Age: 4.0
Sex: M
Vaccine: DTAPIPV, MMR
Symptoms: Vaccination complication, Wheezing
Clinical narrative: 1/9/2014-Mother called me; states child's arm started swelling and was red about 3 hrs after vaccines given; child was scratching at arm; denied difficulty breathing, stated child was playing normally. I told her to apply cool or warm compresses, give Tylenol or Motrin, monitor child and if no better or gets worse, to see MD. I phoned her at about 9:30 am next morning (1/10/14), she had client in ER because he had woken up with face, ears and under chin swollen; still no difficulty breathing. States she gave him 2 doses Benadryl on 1/9/14 in the afternoon sometime and last dose at 9pm, along with Tylenol and Motrin. States ER gave him some Keflex and steroid by mouth; she was unsure if they gave him Benadryl, but they had asked her if she had given him any. States they were going to monitor him at that time. I followed up again on 1/13/14, states the ER monitored him for a couple hours and sent him home with Keflex BID for 10 days and orders for cool compresses, Tylenol, Motrin, and to follow up with his MD in 2 weeks. His arm was still red and still had some swelling at the time of call on 1/13. I followed up again yesterday (1/14) and the swelling had gone down some. I followed up again today (phone call 1/15) and she states everything is resolved and he is still taking Keflex. I have reports from ER visit that were faxed to me-Diagnosis Localized reaction to immunizations and secondary cellulitis.
Age: 11.0
Sex: M
Vaccine: HPV4
Symptoms: Local reaction, Oedema, Pain
Clinical narrative: Local redness, soreness and slight edema.
Age: 40.0
Sex: F
Vaccine: FLUR3, FLUX
Symptoms: Asthenia, Inflammation, Neuralgic amyotrophy, Nuclear magnetic resonance imaging abnormal, Pain in extremity
Clinical narrative: Right arm pain, weakness, with mild paresthesias.  Worse at night, within 5 hours of vaccine.  Treated with steroids, Motrin.  Currently starting electro-stimulation and PT.  At this point, some decrease in pain and weakness but not resolved.  Seen by orthopedist, underwent MRI and X-rays.  Diagnosis at this time: Parsonage-Turner Syndrome.
Age: 40.0
Sex: F
Vaccine: FLUR3, FLUX
Symptoms: Paraesthesia, X-ray normal
Clinical narrative: Right arm pain, weakness, with mild paresthesias.  Worse at night, within 5 hours of vaccine.  Treated with steroids, Motrin.  Currently starting electro-stimulation and PT.  At this point, some decrease in pain and weakness but not resolved.  Seen by orthopedist, underwent MRI and X-rays.  Diagnosis at this time: Parsonage-Turner Syndrome.
Age: 40.0
Sex: F
Vaccine: FLUR3, FLUX
Symptoms: Neuralgic amyotrophy, Nuclear magnetic resonance imaging, Vaccination site pain, X-ray limb
Clinical narrative: Right arm pain, weakness, with mild paresthesias.  Worse at night, within 5 hours of vaccine.  Treated with steroids, Motrin.  Currently starting electro-stimulation and PT.  At this point, some decrease in pain and weakness but not resolved.  Seen by orthopedist, underwent MRI and X-rays.  Diagnosis at this time: Parsonage-Turner Syndrome.
Age: 33.0
Sex: F
Vaccine: FLUX, PPV, TDAP
Symptoms: Activities of daily living impaired, Back pain, Chest pain, Chills, Decreased appetite
Clinical narrative: I began feeling soreness in one of my arms (I had vaccines in both) by the middle of the day, but it felt within the expected reaction. The real reactions that started causing concerns began as very severe chest pain on left side (injection site was upper left arm)  and the pain radiated into the middle of my back from the left side as well. The the chest pain was so bad it felt like I might be having a heart attack. This progressed for a few hours. Following a bath (about 8pm) that was prescribed for another health condition, I began having extreme muscle aches over my whole body (similar to when I had the flu many years ago). My lymph nodes--especially in my groin, were so painful I could hardly move without pain. I also had chills and hot flashes, but no actual fever, I was shaking and felt so ill I could hardly move. I lost my appetite even though I hadn't eaten much that day and had to force myself to drink some water so I wouldn't become dehydrated. Worst was I had such extreme pain on my left side that I had trouble dressing and stayed wrapped in a robe for a while. When I eventually put on a t-shirt the pain was so bad that I felt like I was about to lose control of my bowels and bladder. At some point I did have diarrhea twice that evening.
Age: 33.0
Sex: F
Vaccine: FLUX, PPV, TDAP
Symptoms: Diarrhoea, Feeling abnormal, Hot flush, Lymph node pain, Malaise
Clinical narrative: I began feeling soreness in one of my arms (I had vaccines in both) by the middle of the day, but it felt within the expected reaction. The real reactions that started causing concerns began as very severe chest pain on left side (injection site was upper left arm)  and the pain radiated into the middle of my back from the left side as well. The the chest pain was so bad it felt like I might be having a heart attack. This progressed for a few hours. Following a bath (about 8pm) that was prescribed for another health condition, I began having extreme muscle aches over my whole body (similar to when I had the flu many years ago). My lymph nodes--especially in my groin, were so painful I could hardly move without pain. I also had chills and hot flashes, but no actual fever, I was shaking and felt so ill I could hardly move. I lost my appetite even though I hadn't eaten much that day and had to force myself to drink some water so I wouldn't become dehydrated. Worst was I had such extreme pain on my left side that I had trouble dressing and stayed wrapped in a robe for a while. When I eventually put on a t-shirt the pain was so bad that I felt like I was about to lose control of my bowels and bladder. At some point I did have diarrhea twice that evening.
Age: 33.0
Sex: F
Vaccine: FLUX, PPV, TDAP
Symptoms: Mobility decreased, Myalgia, Pain, Pain in extremity, Tremor
Clinical narrative: I began feeling soreness in one of my arms (I had vaccines in both) by the middle of the day, but it felt within the expected reaction. The real reactions that started causing concerns began as very severe chest pain on left side (injection site was upper left arm)  and the pain radiated into the middle of my back from the left side as well. The the chest pain was so bad it felt like I might be having a heart attack. This progressed for a few hours. Following a bath (about 8pm) that was prescribed for another health condition, I began having extreme muscle aches over my whole body (similar to when I had the flu many years ago). My lymph nodes--especially in my groin, were so painful I could hardly move without pain. I also had chills and hot flashes, but no actual fever, I was shaking and felt so ill I could hardly move. I lost my appetite even though I hadn't eaten much that day and had to force myself to drink some water so I wouldn't become dehydrated. Worst was I had such extreme pain on my left side that I had trouble dressing and stayed wrapped in a robe for a while. When I eventually put on a t-shirt the pain was so bad that I felt like I was about to lose control of my bowels and bladder. At some point I did have diarrhea twice that evening.
Age: 5.0
Sex: M
Vaccine: MMR
Symptoms: Vomiting
Clinical narrative: Severe vomiting.
Age: 58.0
Sex: F
Vaccine: TDAP
Symptoms: Pain, Pain in extremity
Clinical narrative: Along with the extreme pain in my arm (expected from tetanus), my WHOLE body experianced the same pain: arms, legs torso. I was incapacitated from this pain. The reaction is not described in TDAP information statement. I spiked fever 101.2  I took aspirin 1st night, didn't help. called Doc next day. Call back in afternoon was told to take large dose (500) acetaminophen, I substituted Tylenol. Today 1/17/14 it is noon and starting to fell better.
Age: 2.0
Sex: M
Vaccine: DTAP, HEPA
Symptoms: Vaccination site erythema
Clinical narrative: 5 1/4 x 3 1/2 in area of erythema to L thigh surrounding vaccination site. Treated with Keflex orally tid x 10 days. Patient seen in clinic 01/13/2014.
Age: 33.0
Sex: M
Vaccine: FLU3
Symptoms: Injection site pain
Clinical narrative: Complaining of pain to R deltoid muscles following administration of the flu vaccine and ever since. Has tried Ibuprofen and cold pack without success.
Age: 58.0
Sex: F
Vaccine: FLU3
Symptoms: Asthenia, Chills, Fatigue, Pyrexia, Respiratory rate increased
Clinical narrative: Rapid onset of hard shaking chills and rapid breathing 24/min. Fever. Temp 102.7. Responded to Tylenol. Low grade fever next day of 99.9 with weakness and fatigue. 2nd day resolved. No nausea/vomiting.
Age: 58.0
Sex: F
Vaccine: FLU3
Symptoms: Tremor
Clinical narrative: Rapid onset of hard shaking chills and rapid breathing 24/min. Fever. Temp 102.7. Responded to Tylenol. Low grade fever next day of 99.9 with weakness and fatigue. 2nd day resolved. No nausea/vomiting.
Age: 14.0
Sex: F
Vaccine: HEPA, HPV4, MNQ
Symptoms: Decreased appetite, Fatigue, Inflammation, Pericarditis, Rash
Clinical narrative: First signs of lupus started to appear. Rash on my face, loss of appetite, weight loss, fatigue, inflammation, pericarditis.