chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Sex: U
Vaccine: HEP
Symptoms: No therapeutic response
Clinical narrative: This case was reported by a healthcare professional and described the occurrence of not responding to therapy in a subject of unspecified age and gender who was vaccinated with hepatitis B (manufacturer unspecified). On an unspecified date in 2012 the subject received 7th dose of hepatitis B vaccine (40 mcg, unknown). On unspecified dates in 2008, the subject received 6th dose, 5th dose, and 4th dose of hepatitis B vaccine (40 mcg, 20 mcg, unknown). On unspecified dates in 2006 the subject received 3rd dose, 2nd dose and 1st dose of hepatitis B vaccine (20 mcg, unknown). At an unspecified time after vaccination with hepatitis B vaccine, the subject experienced not responding to therapy. The subject "received three doses of hepatitis B 20 mcg vaccine in 2006 and did not respond. Subject received in 2008, two 20 mcg doses of hepatitis B vaccine and one 40 mcg dose and did not respond. In 2012, the subject received a 7th dose of 40 mcg." At the time of the report not additional information was provided.
Age: 60.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site erythema, Rash
Clinical narrative: Rash around abdomen redness on injection site.
Sex: F
Vaccine: HEP
Symptoms: No therapeutic response
Clinical narrative: This case was reported by a healthcare professional (also the subject) and described the occurrence of not responding to therapy in a female subject of unspecified age who was vaccinated with ENGERIX B (GlaxoSmithKline). The subject noted a recent needlestick injury. No details were provided. On unspecified dates the subject received 1st dose, 2nd dose, 3rd dose, 4th dose, 5th dose and 6th dose of ENGERIX B. It was reported that the subject had been through two courses of vaccination with ENGERIX B and had not responded. No further details were provided.
Age: 56.0
Sex: F
Vaccine: FLU3
Symptoms: Erythema, Feeling hot, Injection site reaction
Clinical narrative: Patient had hot, red face from nose upward. Half dollar size rxn at injection site. Went to ER. Was given steroid shot, BENADRYL q 6 hours, also dose pack for future rx fill.
Age: 0.17
Sex: F
Vaccine: DTAPHEPBIP, HIBV, PNC, RV5
Symptoms: Crying, Tongue discolouration
Clinical narrative: Received 2 mo old immunizations in morning & by afternoon well-defined purple black in color over anterior 1/3 of tongue - increase with crying.
Age: 70.0
Sex: F
Vaccine: FLU3
Symptoms: Abdominal distension, Feeling cold, Nausea, Tremor, Vomiting
Clinical narrative: Bloating, fullness, violent vomiting and nausea within 2-3 hours of shot. Vomiting and freezing shaking throughout the night.
Age: 3.0
Sex: M
Vaccine: HIBV, MMR, VARCEL, MMR, VARCEL
Symptoms: Incorrect dose administered
Clinical narrative: Extra dose of MMR, VARIVAX & HIB were given in error. Last dose of MMR & VARIVAX were given on 7-26-10. Last dose of HIB given on 4-26-11.
Age: 3.0
Sex: M
Vaccine: HIBV, MMR, VARCEL, MMR, VARCEL
Symptoms: Inappropriate schedule of drug administration, Incorrect dose administered, No adverse event
Clinical narrative: Extra dose of MMR, VARIVAX & HIB were given in error. Last dose of MMR & VARIVAX were given on 7-26-10. Last dose of HIB given on 4-26-11.
Age: 66.0
Sex: M
Vaccine: FLU3
Symptoms: Dyspnoea, Erythema, Eye irritation, Influenza, Pharyngeal erythema
Clinical narrative: BP 250/180 burning eyes/throat, red throat/face, trouble breathing, BENADRYL at hospital.
Age: 66.0
Sex: M
Vaccine: FLU3
Symptoms: Throat irritation
Clinical narrative: BP 250/180 burning eyes/throat, red throat/face, trouble breathing, BENADRYL at hospital.
Age: 65.0
Sex: M
Vaccine: FLU3
Symptoms: Dysphagia, Dyspnoea
Clinical narrative: Had trouble swallowing and breathing.
Age: 3.0
Sex: M
Vaccine: FLU3, MMR, VARCEL
Symptoms: Respiratory disorder, Urticaria, Vomiting
Clinical narrative: 3 yr old who developed hives, vomiting approx 30 mins after receiving his 3 vaccines, given BENADRYL given but child vomited again advised to call 911 seen at ED with resp sxs given epinephrine x 1 with improvement of symptoms - home on allergy med x 1 wk.
Age: 30.0
Sex: F
Vaccine: FLU3
Symptoms: Eyelid oedema, Joint swelling, Pruritus generalised, Urticaria
Clinical narrative: Hives and itching whole body involvement 4 days later- 5 days swelling of ankles wrists eyelids.
Age: 13.0
Sex: M
Vaccine: HPV4
Symptoms: Fall, Head injury, Spinal X-ray normal, Syncope
Clinical narrative: Pt received vaccine (L) deltoid - less than 1 minute later he fainted - falling face first off exam table to floor. He came to within 2 minutes & was responsive. Injury to head from fall. (No redness or swelling at injection site).
Age: 43.0
Sex: F
Vaccine: HEP
Symptoms: Antibody test negative, No therapeutic response
Clinical narrative: This case was reported by a healthcare professional and described the occurrence of not responding to therapy in a 43-year-old female subject who was vaccinated with ENGERIX B adult (GlaxoSmithKline). On unspecified dates the subject received 1st dose, 2nd dose and 3rd dose of ENGERIX B adult (unknown, unknown deltoid). Subsequently, on unspecified dates, the subject received 1st dose, 2nd dose and 3rd dose of ENGERIX B adult (unknown, unknown deltoid) as a 2nd series. An on unspecified dates, the subject received 1st dose, 2nd dose and 3rd dose of ENGERIX B adult (unknown, unknown deltoid) as a 3rd series. On unspecified dates, over 30 days after each vaccination series with ENGERIX B adult, the subject experienced not responding to therapy. The healthcare professional reported that an adult female experienced "lack of expected response" after 3 series of ENGERIX B vaccinations. The subject received a total of 3 full series with ENGERIX B (adult dose) at another clinic that was reportedly given correctly. Titres were drawn over 30 days after each series was completed and the subject had not seroconverted. No dates were provided.
Sex: U
Vaccine: HEP
Symptoms: Antibody test negative, No therapeutic response
Clinical narrative: This case was reported by a healthcare professional and described the occurrence of not responding to therapy in a subject of unspecified age and gender who was vaccinated with ENGERIX B (GlaxoSmithKline). On an unspecified date the subject received 1st dose, 2nd dose and 3rd dose of ENGERIX B (details unknown). On an unspecified date, more than 1 month after the 3rd dose of ENGERIX B, the subject experienced not responding to therapy. It was reported that a titre level was drawn more than 1 month after the 3rd dose in the hepatitis series and those titres were zero. The healthcare professional reported that 4 experienced not responding to therapy (please see case numbers A0962819-21A for the other 3 subject).
Sex: U
Vaccine: HEP
Symptoms: Antibody test negative, No therapeutic response
Clinical narrative: This case was reported by a healthcare professional and described the occurrence of not responding to therapy in a subject of unspecified age and gender who was vaccinated with ENGERIX B (GlaxoSmithKline). On an unspecified date the subject received 1st dose, 2nd dose and 3rd dose of ENGERIX B (details unknown). On an unspecified date, more than 1 month after the 3rd dose of ENGERIX B, the subject experienced not responding to therapy. It was reported that a titre level was drawn more than 1 month after the 3rd dose in the hepatitis series and those titres were zero. The healthcare professional reported that 4 subject experienced not responding to therapy (please see case numbers A0962819-20A and A0962822A for the other 3 subjects).
Sex: U
Vaccine: HEP
Symptoms: Antibody test negative, No therapeutic response
Clinical narrative: This case was reported by a healthcare professional and described the occurrence of not responding to therapy in a subject of unspecified age and gender who was not vaccinated with ENGERIX B (GlaxoSmithKline). On an unspecified date the subject received 1st dose, 2nd dose and 3rd dose of ENGERIX B (details unknown). On an unspecified date, more than 1 month after the 3rd dose of ENGERIX B, the subject experienced not responding to therapy. It was reported that a titre level was drawn more than 1 month after the 3rd dose in the hepatitis series and those titres were zero. The healthcare professional reported that 4 subjects experienced not responding to therapy (please see case numbers A0962819 and A0962821-22A for the other 3 subjects).
Age: 0.55
Sex: F
Vaccine: DTAPIPVHIB, FLU3, HEP, PNC, RV5
Symptoms: Fall, Injection site mass, Injection site swelling, Underdose
Clinical narrative: This case was reported by a healthcare professional and described the occurrence of swelling injection site in a 6-month-old female subject who was vaccinated with ENGERIX B (GlaxoSmithKline). Concurrent vaccination included PENTACEL (Sanofi Pasteur), influenza vaccine unspecified (Sanofi Pasteur), PREVNAR (Wyeth Labs) and rotavirus vaccine (Merck) all given on 21 March 2012. There were no concurrent medications. On 21 March 2012 at 11:29 the subject received 3rd dose of ENGERIX B at 0.5 ml in the left thigh. On 21 March 2012, less than one day after vaccination with ENGERIX B, the subject experienced swelling injection site. The child was taken to the emergency room by her mother because of the injection site swelling, but the child was not admitted. It was additionally reported that the child kicked during the ENGERIX B injection and the complete contents did not get administered. This was a vaccine underdose. At the time of reporting the outcome of injection site swelling was unspecified. The healthcare professional considered the injection site swelling possibly related to vaccination with ENGERIX B. Follow-up information was received on 24 April 2012 via healthcare professional. The subject was given the injection on 21 March 2012 and was seen in the emergency room for a fall on 24 March 2012. The mother had "noted the swelling at the injection site was on 22 March 2012 (previously reported 21 March 2012) and was concerned that it may have somehow caused the fall. The ER physician reassured the parents that the mild 'lump' at the site was normal and not related to the fall". The event of swelling at injection site was resolved at the time of the report. The reporting healthcare professional considered that event possibly related to vaccination with ENGERIX B.
Age: 25.0
Sex: F
Vaccine: FLU3
Symptoms: Breath sounds abnormal, Bruxism, Convulsion, Dizziness, Dyspnoea
Clinical narrative: Patient reported feeling faint after receiving vaccine, so she laid down on the ground & put her knees up. A couple minutes later, she said she was about to faint then went unconscious. Immediately after going unconscious, she began having involuntary muscle contractions, mainly in her arms, neck & face & she was moaning & gasping for breath. Within 30-60 seconds, she was breathing noisily and clenching her teeth. After 3-4 minutes, the seizure/convulsive syncope ended & she woke up. She was checked out by EMS, who were called at the beginning of the incident & she refused to go to the hospital b/c she said this has happened to her most of her life, including when receiving any vaccine b/c her blood pressure dropping so low. She has been seen for this issue in the past.
Age: 25.0
Sex: F
Vaccine: FLU3
Symptoms: Loss of consciousness, Moaning, Muscle contractions involuntary, Syncope
Clinical narrative: Patient reported feeling faint after receiving vaccine, so she laid down on the ground & put her knees up. A couple minutes later, she said she was about to faint then went unconscious. Immediately after going unconscious, she began having involuntary muscle contractions, mainly in her arms, neck & face & she was moaning & gasping for breath. Within 30-60 seconds, she was breathing noisily and clenching her teeth. After 3-4 minutes, the seizure/convulsive syncope ended & she woke up. She was checked out by EMS, who were called at the beginning of the incident & she refused to go to the hospital b/c she said this has happened to her most of her life, including when receiving any vaccine b/c her blood pressure dropping so low. She has been seen for this issue in the past.
Sex: U
Vaccine: HEP
Symptoms: Abdominal pain, Nausea, Pyrexia
Clinical narrative: This case was reported by a healthcare professional and described the occurrence of abdominal pain in an adult subject of unspecified gender who was vaccinated with ENGERIX B (GlaxoSmithKline). On 27 December 2011 the subject received a dose of ENGERIX B (20 mcg/ml, unknown) as the 2nd or 3rd in the series. On 29 December 2011, 2 days after vaccination with ENGERIX B, the subject experienced abdominal pain, fever and nausea. At the time of reporting the events were resolved. The healthcare professional reported a second adult with same events following ENGERIX B vaccination (see case ID A0960622A for further details).
Age: 52.0
Sex: M
Vaccine: FLU3
Symptoms: Injection site cellulitis
Clinical narrative: Cellulitis at injection site. Treatment with KEFLEX.
Sex: U
Vaccine: HEP
Symptoms: Abdominal pain, Nausea, Pyrexia
Clinical narrative: This case was reported by a healthcare professional and described the occurrence of abdominal pain in an adult subject of unspecified gender who was vaccinated with ENGERIX B (GlaxoSmithKline). On 30 December 2011 the subject received a dose of ENGERIX B (20 mcg/ml, unknown) as the 2nd or 3rd dose in the series. That evening on 30 December 2011, within hours of vaccination with ENGERIX B, the subject experienced abdominal pain, fever and nausea. At the time of reporting the events were resolved. The healthcare professional reported a second adult with same events following ENGERIX B vaccination (see case ID A0960623A for further details).
Sex: F
Vaccine: HEP
Symptoms: Headache, Malaise, Myalgia, Pain, Pyrexia
Clinical narrative: This case was reported by a healthcare professional and described the occurrence of pain in a female subject of unspecified age who was vaccinated with Hepatitis B vaccine (manufacturer unspecified). On an unspecified date more than 10 years prior to the report, the subject received 1st dose of Hepatitis B vaccine (details unknown). At an unspecified time after vaccination with Hepatitis B vaccine, the subject experienced aches (pain) and feeling unwell. On an unspecified date more than 10 years prior to report, the subject received 2nd dose of Hepatitis B vaccine (details unknown). At an unspecified time after vaccination with Hepatitis B vaccine, the subject experienced fever, "severe" myalgia and headache. Hepatitis B vaccine course was discontinued. At the time of reporting the outcomes of the events were unspecified. The healthcare professional reported that the subject was alive and 33 years old at the time of the report. She had no further information as the vaccine was administered by a different facility.
Age: 18.0
Sex: M
Vaccine: HEP
Symptoms: Antibody test negative, Convulsion, No therapeutic response
Clinical narrative: This case was reported by a physician and described the occurrence of seizure in a 18-year-old male subject who was vaccinated with ENGERIX B (GlaxoSmithKline). On an unspecified date the subject received unspecified dose of ENGERIX B (unknown). Within a few weeks of vaccination with ENGERIX B, the subject experienced seizures. This case was assessed as medically serious by GSK. At the time of reporting the outcome of the event was unspecified. Follow-up information was received on 18 January 2012 from the physician. Concurrent medical condition included seizure disorder. On unspecified dates, the subject received 1st, 2nd and 3rd doses of ENGERIX B (details unknown). On an unspecified date after being vaccinated with ENGERIX B, the subject had a "negative titre" [not responding to therapy]. On an unspecified date, the subject received a 4th dose of ENGERIX B (details unknown). On an unspecified date after the 4th dose of ENGERIX B, the subject had a seizure. The event was considered resolved. On an unspecified date, one month after 4th dose of ENGERIX B, the subject received a 5th dose of ENGERIX B (details unknown) and "had no problems". The physician reported that he could not "correlated the two".
Age: 50.0
Sex: F
Vaccine: HEP
Symptoms: Fatigue, Headache, Influenza like illness, Nausea
Clinical narrative: This case was reported by a consumer and described the occurrence of fatigue in a 50-year-old female subject who was vaccinated with HEPATITIS B VACCINE (manufacturer unspecified0. A physician or other health care professional has not verified this report. Concurrent medications included unknown concurrent medication (CQ10) and Omega-3 marine triglycerides (Omega 3 fish oil). On 7 December 2011 at 10:00 the subject received 3rd dose of HEPATITIS B VACCINE in the left arm. On 7 December 2011, within hours of vaccination with HEPATITIS B VACCINE (the symptoms presented the same afternoon following the morning vaccination), the subject experienced fatigue, headache, nausea and flu-like symptoms. At the time of reporting the events were unresolved. The subject reported that she was fine prior to vaccination with HEPATITIS B VACCINE. Follow up information received from the physician on 12 December 2011. Concurrent medical conditions included sulfa allergy and drug sensitivity ("known sensitive to medication in general"). The physician stated that the subject was not on any concomitant medications. Historic vaccination included ENGERIX B; GlaxoSmithKline: unknown route; given in 2007. The physician reported that the subject was vaccinated on 07 December 2011 with ENGERIX B (GlaxoSmithKline) and experienced flu-like symptoms. The physician considered the event as probably related to the ENGERIX B vaccine. The physician reported that she had never had a subject with flu-like symptoms that had "persisted this long". No further details was provided.
Age: 33.0
Sex: M
Vaccine: FLUX, HEP
Symptoms: Injection site pain
Clinical narrative: This case was reported by a healthcare professional and described the occurrence of injection site pain in a 33-year-old male subject who was vaccinated with ENGERIX B (GlaxoSmithKline). Previous vaccination included 1st dose of hepatitis B vaccine recombinant (manufacturer unspecified) given on an unspecified date. Concurrent vaccination included influenza vaccine 2011-12 season (manufacturer unspecified) given on 14 November 2011. On 14 November 2011 the subject received 2nd dose of hepatitis B vaccine administered as ENGERIX B at 1.0 ml in the left deltoid. On 14 November 2011, less than one day after vaccination with ENGERIX B, the subject experienced injection site pain. At the of reporting the event was improved. The healthcare professional considered the event was possibly related to vaccination with ENGERIX B.
Age: 29.0
Sex: F
Vaccine: HEP
Symptoms: Abdominal pain, Decreased appetite, Diarrhoea, Weight decreased
Clinical narrative: This case was reported by a healthcare professional and described the occurrence of abdominal pain in a female subject aged 20-29 years who was vaccinated with ENGERIX B (GlaxoSmithKline). Concurrent medical conditions included unspecified allergies. On an unspecified date the subject received 1st dose of ENGERIX B (unknown route, unknown site). At an unspecified time after vaccination with ENGERIX B, the subject experienced abdominal pain, loose stools, loss of appetite, inability to eat much and weight loss. At the time of reporting the outcomes of the events were unspecified. Follow-up information was received on 22 December 2011 via the reporting nurse practitioner. It was noted that the 29 year old subject had presented to have her 2nd hepatitis B vaccine in the series and at that time, reported abdominal pain, "diarrhea" and "anorexia" following the initial dose of vaccine. First dose of ENGERIX B had been given on 18 October 2011. The events were reported to have begun the same day, 18 October 2011. It was reported that no further doses of vaccine would be given. Allergies to latex, eggs, penicillin and clindamycin were reported along with a medical history of gastroesophageal reflux disease. No alcohol or tobacco use was reported. No concurrent medications were received.
Sex: U
Vaccine: HEP
Symptoms: Rash
Clinical narrative: this case was reported by a healthcare professional (nurse practitioner) and described the occurrence of rash in a subject of unspecified age and gender who was vaccinated with ENGERIX B (GlaxoSmithKline). On an unspecified date the subject received unspecified dose of ENGERIX B (unknown details). One week after vaccination with ENGERIX B, the subject experienced rash. The healthcare professional requested information on any subjects experiencing a rash a wee after vaccination with ENGERIX B. According to the healthcare professional, the physician had not yet determined whether the rash was related to the vaccine or something else. The healthcare professional was not willing to provide the patient specific information. At the time of reporting the outcome of the event was unspecified.
Age: 58.0
Sex: F
Vaccine: FLU3, PPV
Symptoms: Infection, Injection site erythema, Injection site pain, Injection site swelling, Injection site warmth
Clinical narrative: Pt came into pharmacy with arm red & swollen around injection site. She said it felt hot and tender to touch - told her to go to take care clinic - she is going to Dr. tomorrow. (rt arm) 1/15/13.
Age: 4.0
Sex: F
Vaccine: FLU3
Symptoms: Influenza A virus test positive, Influenza B virus test positive
Clinical narrative: Initial report received from a vaccine provider on 07 January 2013. This case is not medically confirmed as the reporter was not identified as a healthcare professional or not. The report involves a cluster of 6 children from the same reporter and same lot number UH753AB. This case captures one of the children and the other children are captured in cases 2012-11111, 2013-00526, 2013-00527, 2013-00529 and 2013-00530. A four year-old female patient whose illness at the time of vaccination was reported as "N/A" and past medical history was unknown had received a dose of FLUZONE (lot number UH753AB, IM) on 06 November 2012 and tested positive for Influenza A and influenza B via the Binaxnow quick test on 10 November 2012. The patient's outcome was not recovered. Documents held by sender: none.
Age: 2.0
Sex: F
Vaccine: FLU3
Symptoms: Influenza A virus test positive, Influenza B virus test positive
Clinical narrative: Initial report received from a vaccine provider on 07 January 2013. This case is not medically confirmed as the reporter was not identified as a healthcare professional or not. The report involves a cluster of 6 children from the same reporter and same lot number UH753AB. This case captures one of the children and the other children are captured in cases 2012-11111, 2013-00526, 2013-00528, 2013-00529 and 2013-00530. A two year-old female patient whose illness at the time of vaccination was reported as "N/A" and past medical history was unknown had received a dose of FLUZONE (lot number UH753AB, IM) on 04 December 2012 and tested positive for Influenza A and influenza B via the Binaxnow quick test on 10 December 2012. The patient had received on 09 October 2012 a dose of FLUZONE (lot number, route and site of administration not reported) and a left leg dose of ACTHIB, lot number UH624AH (sanofi pasteur SA lot number H1153-1) (route of administration not reported). On 02 November 2012, the patient received a left leg dose of IPOL, lot number H1340 (route of administration not reported). The patient's outcome was not recovered. Documents held by sender: none.
Sex: U
Vaccine: RV5
Symptoms: Expired drug administered, No adverse event
Clinical narrative: Information has been received from a certified medical assistant (C.M.A.), concerning a patient of unknown age and gender. On 14-JAN-2013, the patient was vaccinated with a dose of ROTATEQ (dose, route and frequency were not reported) (Lot #: 0529AA; expiration date: 13-DEC-2012), that had expired. There were no adverse symptoms reported. Additional information has been requested.
Sex: U
Vaccine: DTAPIPVHIB, FLU3, PNC13, RV5
Symptoms: Crying, Pyrexia
Clinical narrative: Fever & crying non-stop, began within 3 hours after vaccines.
Age: 10.0
Sex: F
Vaccine: FLU3
Symptoms: Influenza A virus test positive, Influenza B virus test positive
Clinical narrative: Initial report received from a vaccine provider on 07 January 2013. This case is not medically confirmed as the reporter was not identified as a healthcare professional or not. The report involves a cluster of 6 children from the same reporter and same lot number UH753AB. This case captures one of the children and the other children are captured in cases 2012-11111, 2013-00527, 2013-00528, 2013-00529 and 2013-00530. A 10 year-old female patient whose illness at the time of vaccination was reported as "N/A" and past medical history was unknown had received a dose of FLUZONE (lot number UH753AB, IM) on 05 October 2012 and tested positive for Influenza A and influenza B via the Binaxnow quick test on 21 November 2012. The patient's outcome was not recovered. Documents held by sender: none.
Age: 42.0
Sex: M
Vaccine: TDAP
Symptoms: Immediate post-injection reaction, Muscular weakness, Neuralgia
Clinical narrative: Initial report was received on 03 January 2013 from a non-healthcare professional. A 42 year-old male patient who had no illness at the time of vaccination, had received on 03 December 2012 an intramuscular left deltoid injection of ADACEL, lot number C4181AA and immediately after vaccination, experienced neuropathic pain and weakness in the left arm. As of 03 January 2013, the patient continued to have the neuropathic pain and weakness in the left arm. Treatments were not reported. No further information was available at the time of the report. The patient's outcome was not recovered. Documents held by sender: none.
Age: 67.0
Sex: F
Vaccine: FLU3
Symptoms: Injected limb mobility decreased, Pain in extremity
Clinical narrative: Intense soreness, can't move arm since 1-13-13.
Age: 42.0
Sex: F
Vaccine: HEP, TDAP
Symptoms: Pruritus, Urticaria
Clinical narrative: Patient complained she experienced itching and "hives" of her arms and trunk 2-3 hours after vaccine administered.  Reported this to health department on 01-16-13, self medicating with OTC Benadryl.
Age: 55.0
Sex: M
Vaccine: FLU3, PPV
Symptoms: Injection site swelling
Clinical narrative: Swelling about the size of half a zucchini (per the patient) located on the R arm (due to Pneumovax). It tapers down the arm toward the elbow. Patient iced the swelling and it was reduced. Also took ibuprofen and reports it is improving.
Age: 68.0
Sex: M
Vaccine: PPV
Symptoms: Chills, Confusional state, Hypotension, Injection site erythema, Injection site swelling
Clinical narrative: Fever 102 F, 103 F, severe confusion with mental status changes, chills/rigors, hypotension, redness and raised skin surrounding injection site.
Age: 68.0
Sex: M
Vaccine: PPV
Symptoms: Mental status changes, Pyrexia
Clinical narrative: Fever 102 F, 103 F, severe confusion with mental status changes, chills/rigors, hypotension, redness and raised skin surrounding injection site.
Age: 55.0
Sex: M
Vaccine: FLU3
Symptoms: Borrelia test, Drooling, Eye disorder, Renal function test, Sensory loss
Clinical narrative: Hours after vaccination patient experienced drooling from left side of lips and started losing sensation on left side of face. Unable to close left eye.  Diagnosed with Bells palsy.   Treatment prednisone 60 MG for 10 days, valacyclovir 1000 mg for 7 days, Natural tears and erythromycin ointment for eye.
Age: 55.0
Sex: M
Vaccine: FLU3
Symptoms: VIIth nerve paralysis
Clinical narrative: Hours after vaccination patient experienced drooling from left side of lips and started losing sensation on left side of face. Unable to close left eye.  Diagnosed with Bells palsy.   Treatment prednisone 60 MG for 10 days, valacyclovir 1000 mg for 7 days, Natural tears and erythromycin ointment for eye.
Age: 4.0
Sex: M
Vaccine: FLU3
Symptoms: Rash erythematous, Skin warm
Clinical narrative: Nickel size area of erythema with "small bumps" per mother. Area is warm to the touch. Referred to primary care provider for assessment.
Age: 9.0
Sex: F
Vaccine: FLU3
Symptoms: Influenza A virus test positive, Influenza B virus test positive
Clinical narrative: Initial report received from a vaccine provider on 07 January 2013. This case is not medically confirmed as the reporter was not identified as a healthcare professional or not. The report involves a cluster of 6 children from the same reporter and same lot number UH753AB. This case captures one of the children and the other children are captured in cases 2012-11111, 2013-00526, 2013-00527, 2013-00528 and 2013-00530. A nine year-old female patient whose illness at the time of vaccination was reported as "N/A" and past medical history was unknown had received a dose of FLUZONE (lot number UH753AB, IM) on 06 November 2012 and tested positive for Influenza A and influenza B via the Binaxnow quick test on 14 November 2012. The patient's outcome was not recovered. Documents held by sender: none.
Age: 17.0
Sex: M
Vaccine: FLU3
Symptoms: Syncope
Clinical narrative: Patient with 2 syncope episodes 5 min after flu shot. Patient was transferred to ER by paramedics in stable condition for further evaluation and care.
Age: 70.0
Sex: M
Vaccine: FLU3
Symptoms: Activities of daily living impaired, C-reactive protein, Musculoskeletal pain, Pain in extremity, Pelvic pain
Clinical narrative: Soreness in shoulders, arms, hands progressed to pelvic area & by 12/4/12 had difficulty getting out of bed. Felt better with exercise & normal activity. Spoke with MD 12/14 & saw MD 1/4, 1/11, 1/18 when he began Methylprednisolone orally. Cardiologist also called him about lab results.
Age: 70.0
Sex: M
Vaccine: FLU3
Symptoms: Red blood cell sedimentation rate, Rheumatoid factor
Clinical narrative: Soreness in shoulders, arms, hands progressed to pelvic area & by 12/4/12 had difficulty getting out of bed. Felt better with exercise & normal activity. Spoke with MD 12/14 & saw MD 1/4, 1/11, 1/18 when he began Methylprednisolone orally. Cardiologist also called him about lab results.
Age: 65.0
Sex: M
Vaccine: FLU3
Symptoms: Amnesia, Convulsion, Feeling abnormal, Nuclear magnetic resonance imaging brain normal, Scan with contrast normal
Clinical narrative: Loss of memory from 11 pm; not feeling right; severe seizure at 5:00 AM.
Age: 71.0
Sex: F
Vaccine: FLU3
Symptoms: Drug administered at inappropriate site, Injection site erythema, Injection site haematoma, Injection site swelling, Injection site warmth
Clinical narrative: Pt was given the injection low in the left upper arm.  The site was bruised, red, swollen and hot.  Dr checked the site and instructed patient to use ice and if it got worse to contact her PCP.
Age: 23.0
Sex: M
Vaccine: ANTH, TYP, YF
Symptoms: Pruritus
Clinical narrative: On 1/15/13 gave vaccines at around 1335. At 1730 he took nutritional supplement and around 1830 felt itching in armpit. Took restoril at 1930 and woke up to more itching at 1400 on 1/16/13. Referred to allergy clinic. Temp exempt from anthrax/yellow fever vax. Member denies taking oral typhoid.
Age: 59.0
Sex: M
Vaccine: FLU3, HEP
Symptoms: Injection site pain, Injection site swelling, X-ray limb
Clinical narrative: Pt reports 8/10 pain in left upper arm (deltoid area). Pt is currently swollen in injection area and around.
Age: 59.0
Sex: M
Vaccine: FLU3
Symptoms: Contusion, Injection site erythema, Injection site swelling, Injection site warmth
Clinical narrative: Injection site is hot, red and swollen. Noted bruising shortly after injection No fever, numbness or tingling in arm.
Age: 37.0
Sex: M
Vaccine: PPV
Symptoms: Erythema, Feeling hot, Injection site erythema, Injection site swelling, Injection site warmth
Clinical narrative: Redness, warmth and swelling from injection site at deltoid to below elbow. Injection received 01/14/13. Reaction reported by patient via phone this morning as most severe 01/16/13.
Age: 37.0
Sex: M
Vaccine: PPV
Symptoms: Swelling
Clinical narrative: Redness, warmth and swelling from injection site at deltoid to below elbow. Injection received 01/14/13. Reaction reported by patient via phone this morning as most severe 01/16/13.
Age: 48.0
Sex: F
Vaccine: FLU3
Symptoms: Rash, Rash pruritic
Clinical narrative: Slightly itchy fine raised rash over trunk, neck, arms, upper legs. No treatement. Rash remained in morning, but no longer itchy, and gone later in the day.
Age: 46.0
Sex: F
Vaccine: FLU3
Symptoms: Chills, Headache, Pain, Pyrexia
Clinical narrative: Chills, body ache, fever (101), headache.
Age: 24.0
Sex: M
Vaccine: FLU3
Symptoms: Blepharitis, Dysphagia, Eye pain, Fatigue, Gingival inflammation
Clinical narrative: Pain in throat, difficulty swallowing, pain in eyes, inflamed eyelids, bloodshot and painful eyes, itching in tongue, inflamed and painful gums, fatigue, pain in injection site. Symptoms lasted throughout the night. By 1:00 PM 01/16/2013 all symptoms had abated except pain in injection site and pain in eyes.
Age: 24.0
Sex: M
Vaccine: FLU3
Symptoms: Gingival pain, Injection site pain, Ocular hyperaemia, Oropharyngeal pain, Tongue pruritus
Clinical narrative: Pain in throat, difficulty swallowing, pain in eyes, inflamed eyelids, bloodshot and painful eyes, itching in tongue, inflamed and painful gums, fatigue, pain in injection site. Symptoms lasted throughout the night. By 1:00 PM 01/16/2013 all symptoms had abated except pain in injection site and pain in eyes.
Age: 73.0
Sex: F
Vaccine: FLU3
Symptoms: Chills, Cough, Dizziness, Dyspnoea, Pharyngeal oedema
Clinical narrative: Dizziness, chills, breathing difficulty cough, throat swelling, sinus swelling - lasted about 12-14 hrs after time of administration. No treatment required.
Age: 73.0
Sex: F
Vaccine: FLU3
Symptoms: Sinus disorder
Clinical narrative: Dizziness, chills, breathing difficulty cough, throat swelling, sinus swelling - lasted about 12-14 hrs after time of administration. No treatment required.
Age: 23.0
Sex: M
Vaccine: FLU3
Symptoms: Syncope
Clinical narrative: Patient fainted for a short period of time and regained consciousness.
Age: 21.0
Sex: M
Vaccine: FLU3
Symptoms: Rash
Clinical narrative: Patient developed a raised rash on both of his elbows.
Age: 68.0
Sex: M
Vaccine: VARZOS
Symptoms: Drug administered at inappropriate site, Influenza like illness
Clinical narrative: This spontaneous report as received from a consumer refers to a 68 years old male patient with aspirin allergy. Drug reactions/allergies included aspirin. On 28-DEC-2012, the patient received a dose of ZOSTAVAX (Subcutaneous Injection) (lot # and dose not reported0. No other co-suspects were reported. Concomitant therapy included albuterol sulfate, COMBIVENT and ASMANEX TWISTHALER. On 10-JAN-2013, the patient experienced flu-like symptoms after receiving ZOSTAVAX. The patient also reported that ZOSTAVAX was administered in his stomach, rather than in the arm as the prescribing information indicated. No treatment was given. The outcome of the event was recovering. The relatedness of the event with ZOSTAVAX was not provided. Additional information is not expected.
Age: 22.0
Sex: F
Vaccine: HPV4, TDAP
Symptoms: Presyncope
Clinical narrative: Near syncope after injection.
Sex: F
Vaccine: HPV4
Symptoms: Syncope
Clinical narrative: This spontaneous report was received from a physician via a sales representative concerning a female patient of unknown age who on an unknown date was vaccinated with a dose of GARDASIL (route, lot number and expiration date were not provided). No other co-suspects were reported. No concomitant medications were reported. The physician reported that the patient fainted after receiving the dose of GARDASIL. No treatment information was reported. The outcome of fainted was unknown. The relatedness for fainted was unknown for GARDASIL. Additional information is not expected.
Age: 62.0
Sex: M
Vaccine: VARZOS
Symptoms: Injection site erythema, Injection site induration
Clinical narrative: This spontaneous report as received from a registered pharmacist refers to a 62 years old male patient with no pertinent medical history and no drug reactions or allergies, who on 12-JAN-2013, was vaccinated with a dose of ZOSTAVAX (lot number H018093, Exp. Date: 04-JAN-2014) (dose and route not reported). No other co-suspects were reported. No concomitant medications were reported. It was reported that on 13-JAN-2013, the patient developed redness and hardness at the injection site. No treatment was given for the experience. No lab diagnostics studies were performed. At the time of the report, the patient had not recovered. The relatedness for patient developed redness and hardness at the injection site was unknown for ZOSTAVAX. Additional information has been requested.
Age: 69.0
Sex: M
Vaccine: PPV, PPV
Symptoms: Cough, Mass, Oedema peripheral, Pain in extremity, Pyrexia
Clinical narrative: Information has been received from a 69 year old male consumer, concerning himself. The patient had no pertinent medical history and no known drug reactions or allergies. On 07-DEC-2012, the patient was vaccinated with a dose of PNEUMOVAX23 1 injection (route and frequency were not reported) (Lot #: HH009286). Concomitant medications included: Influenza Virus Vaccine (manufacturer unknown), received on 06-DEC-2012. On 08-DEC-2012, 8 hours after receiving PNEUMOVAX23, the patient's right arm swelled up to twice its normal size from the shoulder to the elbow. Consumer also reported that his arm was sore and lasted for a week. Consumer also stated that a lump formed on his lip the size of a marble, and a fever and cough developed a few days after the injection. The patient did not seek medical attention. No treatment was given for the events. No lab diagnostic studies were performed. At the time of the report, the patient was recovering from his arm swelled up to twice is normal size from the shoulder to the elbow, lump on his lip, and cough. The patient's outcome for fever was unknown. The patient had recovered from his arm was sore. The relatedness for his right arm swelled up to twice its normal size from the shoulder to the elbow, cough, fever, a lump formed on his lip the size of a marble and his arm was sore was unknown for PNEUMOVAX23. Additional information has been requested.
Age: 69.0
Sex: M
Vaccine: PPV, PPV
Symptoms: Cough, Lip swelling, Oedema peripheral, Pain in extremity, Pyrexia
Clinical narrative: Information has been received from a 69 year old male consumer, concerning himself. The patient had no pertinent medical history and no known drug reactions or allergies. On 07-DEC-2012, the patient was vaccinated with a dose of PNEUMOVAX23 1 injection (route and frequency were not reported) (Lot #: HH009286). Concomitant medications included: Influenza Virus Vaccine (manufacturer unknown), received on 06-DEC-2012. On 08-DEC-2012, 8 hours after receiving PNEUMOVAX23, the patient's right arm swelled up to twice its normal size from the shoulder to the elbow. Consumer also reported that his arm was sore and lasted for a week. Consumer also stated that a lump formed on his lip the size of a marble, and a fever and cough developed a few days after the injection. The patient did not seek medical attention. No treatment was given for the events. No lab diagnostic studies were performed. At the time of the report, the patient was recovering from his arm swelled up to twice is normal size from the shoulder to the elbow, lump on his lip, and cough. The patient's outcome for fever was unknown. The patient had recovered from his arm was sore. The relatedness for his right arm swelled up to twice its normal size from the shoulder to the elbow, cough, fever, a lump formed on his lip the size of a marble and his arm was sore was unknown for PNEUMOVAX23. Additional information has been requested.
Age: 52.0
Sex: F
Vaccine: FLU3
Symptoms: Glossodynia, Lip pain, Rash macular
Clinical narrative: Tongue & lips felt burned/scalded splotches on both hands - about quarter size.
Age: 40.0
Sex: F
Vaccine: FLU3
Symptoms: Erythema, Nodule, Pain, Pruritus, Skin discolouration
Clinical narrative: (Per patient) the evening after getting vaccine, she noticed area was sore & had a knot (which she says she knew to expect). Next morning, area was warm to touch, knot was bigger & had turned red. Keeps getting bigger, is hard, & sore to touch. Also itching now, but just discolored (not so much red anymore). She had Dr. appt. today & let him look at it, but he said he didn't know of anything he could do about it, I recommended pt. seek emergency medical attention if swelling spread to throat & she agreed.
Age: 40.0
Sex: F
Vaccine: FLU3
Symptoms: Skin warm
Clinical narrative: (Per patient) the evening after getting vaccine, she noticed area was sore & had a knot (which she says she knew to expect). Next morning, area was warm to touch, knot was bigger & had turned red. Keeps getting bigger, is hard, & sore to touch. Also itching now, but just discolored (not so much red anymore). She had Dr. appt. today & let him look at it, but he said he didn't know of anything he could do about it, I recommended pt. seek emergency medical attention if swelling spread to throat & she agreed.
Age: 0.53
Sex: M
Vaccine: DTAPHEPBIP, FLU3, PNC13
Symptoms: Injection site erythema, Injection site induration, Injection site rash, Injection site warmth
Clinical narrative: Received 3 vaccinations on 1-14-13, when Mom looked today, all three sites were red, with hardened bumps, very hot to the touch.
Age: 3.0
Sex: F
Vaccine: FLU3
Symptoms: Drug administered to patient of inappropriate age, No adverse event
Clinical narrative: None, no treatment needed.
Sex: F
Vaccine: VARZOS
Symptoms: Musculoskeletal pain
Clinical narrative: This spontaneous report as received from a physician refers to a female patient of unknown age. The patient was vaccinated with ZOSTAVAX (lot# was unknown) one years ago in January 2012. No concomitant medications were reported. The reporter reported the patient had a sore shoulder for 1 year after receiving ZOSTAVAX. The shoulder was the same arm as the ZOSTAVAX injection. It did not report whether the patient sought medical attention. No treatment information was reported. The event outcome was unknown at the time of this report. Additional information is not expected.
Age: 3.0
Sex: M
Vaccine: FLU3
Symptoms: Injection site erythema, Injection site swelling, Injection site warmth
Clinical narrative: Left upper and lower arm moderately swollen with warmth and redness. Tx with BENADRYL 1 tsp Q 6 hours and use cool compresses for swelling.
Age: 71.0
Sex: M
Vaccine: FLU3, PPV
Symptoms: Joint swelling, Local swelling, Pyrexia
Clinical narrative: Initial information has been received from a registered nurse concerning a 71 years old male patient with hypertension and a history of arthritis (AAA), thyroid nodule, prostate cancer, hypercholesterol, tobacco user, erectile dysfunction and shingles (2009). On 02-OCT-2012, the patient was vaccinated with PNEUMOVAX23 intramuscularly in the right deltoid area (dose, lot number were not reported). Other suspect therapies were not reported. Concomitant medications included FLUZONE (lot number 04496AA), aspirin, VIAGRA, Omega-3, hydrochlorothiazide (manufacturer unknown) and low dose statin (unspecified). The patient had not acutely illness at the time of vaccination. On 05-OCT-2012, 3 days after the vaccination, the patient developed low grade fever, thumb swelling and bilateral wrist swelling. The patient received non-steroidal anti-inflammatory drug (unspecified) (NSAIDS) as corrective medication. Laboratory investigations were none as per reporter. On an unspecified date, the patient recovered from the events. The patient sought medical attention by contacting a doctor at the health department. Additional information has been requested.
Age: 35.0
Sex: F
Vaccine: FLU3
Symptoms: Dyspnoea, Fatigue, Neck pain, Pain
Clinical narrative: Pt experienced shooting pain through neck, trouble breathing. Went to ER. She still feels tired but symptoms have slightly improved.
Age: 53.0
Sex: F
Vaccine: FLU3
Symptoms: Lymph node pain, Lymphadenopathy
Clinical narrative: Flu vaccine received Monday 1/14/13 - Patient states next day noticed tenderness in lymph node approx 1-2" below (R) axillary area. Had mammogram scheduled - technician noticed inflammation of node. Pt states tender to touch. No fever noted.
Age: 0.42
Sex: F
Vaccine: FLU3
Symptoms: Drug administered to patient of inappropriate age, No adverse event
Clinical narrative: None.
Sex: F
Vaccine: VARZOS
Symptoms: Herpes zoster
Clinical narrative: This spontaneous report was received from a consumer, reporting on herself who on 13-MAR-2012, was vaccinated with a dose of ZOSTAVAX (dose, route and lot number not reported). No other co-suspects were reported. No concomitant medications were reported. The consumer reported that on an unknown date, she experienced the shingles after receiving the vaccine. No treatment information was reported. At the time of the report, the patient's outcome was unknown. The relatedness for patient experienced shingles was unknown for ZOSTAVAX. This is one of several reports from the same source. Additional information has been requested.
Age: 15.0
Sex: F
Vaccine: FLU3
Symptoms: Muscular weakness, Pain in extremity, Syncope
Clinical narrative: Patient had syncopal episode 2 days after flu vaccine (also treated for URI symptom). Pt had residual UE & LE pain & weakness.
Age: 70.0
Sex: F
Vaccine: PPV
Symptoms: Impetigo
Clinical narrative: This spontaneous report as received from a healthcare worker refers to a 70 years old female patient with IV dye allergy and no pertinent medical history. The patient was vaccinated SC with a 0.5 ml dose of PNEUMOVAX23 (lot # 672074/1502AA, Exp. Date: 19-MAY-2013) on 18-OCT-2012. No other co-suspects were reported. Concomitant medications included calcium (unspecified), krill oil, LIPITOR, vitamins (unspecified), VASOTEC and aspirin. On an unknown date the patient developed impetigo after receiving PNEUMOVAX23. The patient saw the physician for medical attention. No treatment was given for the event. The outcome of impetigo was reported as recovered. Additional information has been requested.
Age: 59.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site erythema, Injection site pain, Injection site swelling, Skin reaction
Clinical narrative: This spontaneous report was received from a physician via company representative refers to a currently 59 years old female patient who on 10-JAN-2013 (Thursday) was vaccinated subcutaneously with a 0.65 ml once dose of ZOSTAVAX (Lot # not reported). No other co-suspects were reported. No concomitant medications were reported. On 10-JAN-2013, the patient developed a "localized site reaction in the left arm" which was described as being "red" and "swollen". The patient called on the on-call doctor at the practice the same day and it was determined that there was "no fever, no body aches and no rash" reported. The reporter also mentioned that initially the patient's reaction was not painful until the patient went to an unspecified massage therapist which afterwards, the patient complained it "became painful" (onset date: approximately in January 2013) but was "not warm" to the touch. The patient was told to take BENADRYL and use a heating pad on the injection site and over the next few days, the symptoms improved. Patient's outcome was reported as recovering. The relatedness for the events was unknown for ZOSTAVAX. Additional information has been requested.
Age: 53.0
Sex: F
Vaccine: FLU3
Symptoms: Injection site inflammation, Injection site pain, Injection site pruritus, Injection site rash
Clinical narrative: Rash at injection site, circle like dime size, inflamed, itching & burning.
Age: 72.0
Sex: F
Vaccine: FLU3
Symptoms: Chronic obstructive pulmonary disease, Condition aggravated, Pneumothorax
Clinical narrative: Patient went to ER several hours after receiving flu shot. Patient treated for collapsed lung. ER aware of shot but said collapsed lung was due to COPD exacerbation. Patient treated at hospital. Patient did not agree.
Age: 14.0
Sex: F
Vaccine: HEPA, HPV4, TDAP, HEPA, HPV4
Symptoms: Maternal exposure during pregnancy, No adverse event, Pregnancy test positive
Clinical narrative: No adverse event. Child reported having period on Dec. 15, 2013. Admits to sexually active but using protection. Pregnancy test completed and came back positive for pregnancy on 01/06/2013.