chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 15.0
Sex: F
Vaccine: HEPA, HPV4
Symptoms: Feeling hot, Immediate post-injection reaction, Nausea, Syncope
Clinical narrative: Within 5 mins of receiving immunizations, left warm + nauseous. Stood up + opened door at which point fainted. I saw her + helped her to floor so no injury. After 1 minute recovered. Kept her here for another 10mins. Ok in whole day.
Age: 27.0
Sex: M
Vaccine: SMALL
Symptoms: Biopsy skin abnormal, Scab, Skin lesion, Vaccinia
Clinical narrative: Smallpox vaccine received 24MAR2009.  Symptoms began 13APR2009 with lesions on arms, legs, face, and trunk with clear discharge.  Biopsy was sent to Medical University and tested positive of Vaccinia.  Pt was treated with SELENIUM Sulfide.  Lesions have scabbed over and Pt is no longer considered contagious.  Vaccine was administered on Military base.
Age: 18.0
Sex: F
Vaccine: HPV4
Symptoms: Head injury, Loss of consciousness, Suture insertion
Clinical narrative: Immediately after receiving GARDASIL injection, pt passed out with her head on a desk.  She quickly regained consciousness & required sutures.
Age: 46.0
Sex: M
Vaccine: FLU3
Symptoms: Unevaluable event
Clinical narrative: None stated
Age: 1.3
Sex: M
Vaccine: DTAP, HIBV
Symptoms: Cellulitis, Erythema, Skin warm
Clinical narrative: Localized cellulitis 5 cm X 5 cm red, warm
Age: 5.0
Sex: M
Vaccine: DTAPIPV
Symptoms: Erythema, Induration, Skin warm
Clinical narrative: about 4 - inch area of redness, warmth and induration treated with KEFLEX 500 mg BID x 7d
Age: 51.0
Sex: F
Vaccine: FLU3, PPV
Symptoms: Diarrhoea, Nausea, Pain in extremity, Pyrexia
Clinical narrative: Went to ER on 4-29-09 c/o fever nausea and diarrhea and pain left arm - Followed up @ doctors office 4-30-09 and 5-6-09
Age: 32.0
Sex: M
Vaccine: ANTH, TYP
Symptoms: Antithrombin III, Arthralgia, Asthenia, Blood homocysteine, Cerebrovascular accident
Clinical narrative: Worsening joint pain, numbness (left leg/hand), leg coldness, and stroke after AVA #4: 06 Jan 2003 AVA 1 w/o AE.  AVA2 was given 23 JAN 2003 with complaints of mild joint pain (bilateral knees, ankles and shoulders) that increased to a deep 6/10 ache within 8-12 hours similar to preexisting foot pain but now shoulders hurt, lasted 2 days.  AVA3 on 03 March 2003 - 24 hours later he awoke with 10/10 bilateral ankle, knee, hip, and shoulder pain.  He described the pain as if his joints were being "crushed or as if they were going to burst".  TYLENOL and ADVIL provided only minimal relief (6/10 pain scale).  He reported no restrictions in ADL and was able to work.  Was in physical therapy for chronic lower back pain but stated this discomfort was different.  Duration was 3 days.  9/29/2004 AVA #4 and TYPHOID vaccine w/minimal increased in his chronic joint pain - was on TRAMADOL for chronic back problems.  02 Dec 2004 c/o left leg suddenly went cold and numb w/a sharp jolt of pain after pushing in a clutch.  (on GABAPENTIN and MELOXICAM for pain.)  03 December 2004 (day 64 post AVA #4) he awoke complaining of a sharp pain to left leg, left hand numbness, and inability to drive.  Three days later (6 Dec 2004) he presented to ER for 4/10 chest pain and shortness of breath X 3 days.  He also complained that the left 1/2 of his body, hand, face, chest, abdomen, LUE, LLE were weak (subjective) and numb.  His exam was normal with normal EKG, MRI brain, and lab studies.  He was diagnosed with left paresthesia and C/L spine disc disease.  Follow up evaluation 19 April 2005 with PCP documented he "did not have history of a stroke but had left side numbness due to possible viral infection".  His sensation to touch was normal although he complained of a sensation of numbness.  He reported that his facial numbness took 12 months to fully resolve.  Symptoms:  Joint pain, multiple joints.
Age: 32.0
Sex: M
Vaccine: ANTH, TYP
Symptoms: Chest pain, Dyspnoea, Electrocardiogram, Feeling cold, Hypoaesthesia
Clinical narrative: Worsening joint pain, numbness (left leg/hand), leg coldness, and stroke after AVA #4: 06 Jan 2003 AVA 1 w/o AE.  AVA2 was given 23 JAN 2003 with complaints of mild joint pain (bilateral knees, ankles and shoulders) that increased to a deep 6/10 ache within 8-12 hours similar to preexisting foot pain but now shoulders hurt, lasted 2 days.  AVA3 on 03 March 2003 - 24 hours later he awoke with 10/10 bilateral ankle, knee, hip, and shoulder pain.  He described the pain as if his joints were being "crushed or as if they were going to burst".  TYLENOL and ADVIL provided only minimal relief (6/10 pain scale).  He reported no restrictions in ADL and was able to work.  Was in physical therapy for chronic lower back pain but stated this discomfort was different.  Duration was 3 days.  9/29/2004 AVA #4 and TYPHOID vaccine w/minimal increased in his chronic joint pain - was on TRAMADOL for chronic back problems.  02 Dec 2004 c/o left leg suddenly went cold and numb w/a sharp jolt of pain after pushing in a clutch.  (on GABAPENTIN and MELOXICAM for pain.)  03 December 2004 (day 64 post AVA #4) he awoke complaining of a sharp pain to left leg, left hand numbness, and inability to drive.  Three days later (6 Dec 2004) he presented to ER for 4/10 chest pain and shortness of breath X 3 days.  He also complained that the left 1/2 of his body, hand, face, chest, abdomen, LUE, LLE were weak (subjective) and numb.  His exam was normal with normal EKG, MRI brain, and lab studies.  He was diagnosed with left paresthesia and C/L spine disc disease.  Follow up evaluation 19 April 2005 with PCP documented he "did not have history of a stroke but had left side numbness due to possible viral infection".  His sensation to touch was normal although he complained of a sensation of numbness.  He reported that his facial numbness took 12 months to fully resolve.  Symptoms:  Joint pain, multiple joints.
Age: 32.0
Sex: M
Vaccine: ANTH, TYP
Symptoms: Hypoaesthesia facial, Musculoskeletal pain, Nuclear magnetic resonance imaging brain normal, Pain in extremity, Paraesthesia
Clinical narrative: Worsening joint pain, numbness (left leg/hand), leg coldness, and stroke after AVA #4: 06 Jan 2003 AVA 1 w/o AE.  AVA2 was given 23 JAN 2003 with complaints of mild joint pain (bilateral knees, ankles and shoulders) that increased to a deep 6/10 ache within 8-12 hours similar to preexisting foot pain but now shoulders hurt, lasted 2 days.  AVA3 on 03 March 2003 - 24 hours later he awoke with 10/10 bilateral ankle, knee, hip, and shoulder pain.  He described the pain as if his joints were being "crushed or as if they were going to burst".  TYLENOL and ADVIL provided only minimal relief (6/10 pain scale).  He reported no restrictions in ADL and was able to work.  Was in physical therapy for chronic lower back pain but stated this discomfort was different.  Duration was 3 days.  9/29/2004 AVA #4 and TYPHOID vaccine w/minimal increased in his chronic joint pain - was on TRAMADOL for chronic back problems.  02 Dec 2004 c/o left leg suddenly went cold and numb w/a sharp jolt of pain after pushing in a clutch.  (on GABAPENTIN and MELOXICAM for pain.)  03 December 2004 (day 64 post AVA #4) he awoke complaining of a sharp pain to left leg, left hand numbness, and inability to drive.  Three days later (6 Dec 2004) he presented to ER for 4/10 chest pain and shortness of breath X 3 days.  He also complained that the left 1/2 of his body, hand, face, chest, abdomen, LUE, LLE were weak (subjective) and numb.  His exam was normal with normal EKG, MRI brain, and lab studies.  He was diagnosed with left paresthesia and C/L spine disc disease.  Follow up evaluation 19 April 2005 with PCP documented he "did not have history of a stroke but had left side numbness due to possible viral infection".  His sensation to touch was normal although he complained of a sensation of numbness.  He reported that his facial numbness took 12 months to fully resolve.  Symptoms:  Joint pain, multiple joints.
Age: 32.0
Sex: M
Vaccine: ANTH, TYP
Symptoms: Prothrombin level normal, Spinal X-ray, Spinal X-ray abnormal
Clinical narrative: Worsening joint pain, numbness (left leg/hand), leg coldness, and stroke after AVA #4: 06 Jan 2003 AVA 1 w/o AE.  AVA2 was given 23 JAN 2003 with complaints of mild joint pain (bilateral knees, ankles and shoulders) that increased to a deep 6/10 ache within 8-12 hours similar to preexisting foot pain but now shoulders hurt, lasted 2 days.  AVA3 on 03 March 2003 - 24 hours later he awoke with 10/10 bilateral ankle, knee, hip, and shoulder pain.  He described the pain as if his joints were being "crushed or as if they were going to burst".  TYLENOL and ADVIL provided only minimal relief (6/10 pain scale).  He reported no restrictions in ADL and was able to work.  Was in physical therapy for chronic lower back pain but stated this discomfort was different.  Duration was 3 days.  9/29/2004 AVA #4 and TYPHOID vaccine w/minimal increased in his chronic joint pain - was on TRAMADOL for chronic back problems.  02 Dec 2004 c/o left leg suddenly went cold and numb w/a sharp jolt of pain after pushing in a clutch.  (on GABAPENTIN and MELOXICAM for pain.)  03 December 2004 (day 64 post AVA #4) he awoke complaining of a sharp pain to left leg, left hand numbness, and inability to drive.  Three days later (6 Dec 2004) he presented to ER for 4/10 chest pain and shortness of breath X 3 days.  He also complained that the left 1/2 of his body, hand, face, chest, abdomen, LUE, LLE were weak (subjective) and numb.  His exam was normal with normal EKG, MRI brain, and lab studies.  He was diagnosed with left paresthesia and C/L spine disc disease.  Follow up evaluation 19 April 2005 with PCP documented he "did not have history of a stroke but had left side numbness due to possible viral infection".  His sensation to touch was normal although he complained of a sensation of numbness.  He reported that his facial numbness took 12 months to fully resolve.  Symptoms:  Joint pain, multiple joints.
Age: 80.0
Sex: M
Vaccine: VARZOS
Symptoms: Auricular swelling, Eye swelling, Pruritus, Skin lesion, Swelling
Clinical narrative: Patient developed itching on his back 3 days after receiving the vaccine;  1 day later, he developed swelling + 3 lesions on his right jaw;  1 day later he developed swelling in the left face + eye + ear- all now resolving.
Age: 80.0
Sex: M
Vaccine: VARZOS
Symptoms: Swelling face
Clinical narrative: Patient developed itching on his back 3 days after receiving the vaccine;  1 day later, he developed swelling + 3 lesions on his right jaw;  1 day later he developed swelling in the left face + eye + ear- all now resolving.
Age: 53.0
Sex: F
Vaccine: TDAP
Symptoms: Lethargy, Unevaluable event
Clinical narrative: Non stated. Lethargy
Age: 34.0
Sex: F
Vaccine: VARCEL
Symptoms: Injection site pruritus, Injection site rash, Injection site warmth
Clinical narrative: Rash appeared at site of vaccination. It was warm to touch and slightly itchy. 2 small spots appeared next to it. Rash lasted 5 days.
Age: 10.0
Sex: M
Vaccine: VARCEL
Symptoms: Injection site erythema, Injection site warmth
Clinical narrative: Redness after 24 hours and warmth after injection  Zero fever.
Age: 5.0
Sex: M
Vaccine: HEPA, VARCEL
Symptoms: Injection site erythema
Clinical narrative: Erythema 10ml around injection of chicken pox Vax.
Age: 4.0
Sex: M
Vaccine: DTAP
Symptoms: Erythema, Pain in extremity, Skin warm
Clinical narrative: Left arm red, warm with pain -> treated  with KELFEX -> seen next day on 5/5/9 with response to antibiotic
Age: 1.5
Sex: M
Vaccine: DTAP, VARCEL
Symptoms: Body temperature increased, Injection site erythema, Injection site pain, Injection site swelling, Injection site warmth
Clinical narrative: Lt leg @ injection site showed redness, warmth, swelling.  Area was also tender to touch.  Also started w/temp 99.3 today
Age: 82.0
Sex: M
Vaccine: PPV, VARZOS
Symptoms: Erythema, Full blood count abnormal, Local reaction, Red blood cell sedimentation rate increased, Swelling
Clinical narrative: Large local reaction redness & swelling down into elbow. Clarinex 5 mg
Age: 80.0
Sex: F
Vaccine: PPV
Symptoms: Pain, Pain in extremity
Clinical narrative: Shooting @ throbbing pain L arm + hand. Info given by son. Pt does not speak English.
Age: 60.0
Sex: F
Vaccine: VARZOS
Symptoms: Herpes zoster
Clinical narrative: The patient developed shingles on left side back and lateral chest wall. Antiviral medication not given as it was 1 week after onset of symptoms. The patient was prescribed a pain medication.
Age: 48.0
Sex: F
Vaccine: TDAP
Symptoms: Axillary pain, Body temperature increased, Cellulitis, Erythema, Lymphadenopathy
Clinical narrative: Erythema of the Rt upper arm, temp of 101 X 2 days, itching and pain and tender axillary Adenopathy. Pt given Keflex 500mg tby mouth QID on 04-27-09 cellulitis R deltoid.
Age: 48.0
Sex: F
Vaccine: TDAP
Symptoms: Pruritus, Tenderness
Clinical narrative: Erythema of the Rt upper arm, temp of 101 X 2 days, itching and pain and tender axillary Adenopathy. Pt given Keflex 500mg tby mouth QID on 04-27-09 cellulitis R deltoid.
Age: 5.0
Sex: F
Vaccine: DTAP, IPV, MMR, VARCEL
Symptoms: Injection site erythema, Injection site pain, Injection site swelling
Clinical narrative: Pain, swelling, redness, large circle @ inj site.  Taken to PCP & informed to switch from Ibuprofen to TYLENOL.
Age: 23.0
Sex: F
Vaccine: HPV4
Symptoms: Body temperature increased, Pruritus, Rash, Urticaria
Clinical narrative: Injection given @ 4:30 pm- Pt C/0 itching @ approximately 7:00 pm. Noticed both legs and R arm had hives approximately 10:00 pm. Low grade temp 100.9 on 4/28/09. TC to Pt 4/29/09 slight sand paper rash on legs. Denies SOB. No other problems.
Age: 25.0
Sex: F
Vaccine: TDAP
Symptoms: Arthralgia, Dizziness, Injection site pain, Pyrexia
Clinical narrative: Pt complained of having dizziness, pain at injection site, fever with joint pain.
Age: 4.0
Sex: F
Vaccine: VARCEL
Symptoms: Feeling hot, Induration, Oedema peripheral, Rash papular
Clinical narrative: Swollen right tricep area with induration, warmth, confluent fine papules
Age: 18.0
Sex: F
Vaccine: HEPA, HPV4
Symptoms: Blister, Erythema
Clinical narrative: 4" diameter erythema 1-2mm vesicle in center - has burst
Age: 15.0
Sex: F
Vaccine: HPV4, VARCEL
Symptoms: Injection site erythema, Injection site swelling
Clinical narrative: Swelling in right arm post receiving VARICELLA vaccine.  Swelling & reddness began 4/29/09.  Tx'd with XYZAL 5 mg daily.  Was already on MINOCYCLINE for another DX.
Age: 1.4
Sex: F
Vaccine: FLUX, HEPA, MMR
Symptoms: Dry skin, Pyrexia, Rash, Vomiting
Clinical narrative: Fever 102-103, rash on face - dry cheeks. Vomited once resolved in 24 hour without further fever, rash on new symptoms.
Age: 41.0
Sex: F
Vaccine: RAB
Symptoms: Epistaxis, Headache, Lymphadenopathy, Oropharyngeal pain, Rash generalised
Clinical narrative: This case was received from a health professional. A 41-year-old female patient, with a history of asthma, received an intramuscular left deltoid third dose of IMOVAX (lot number A0259-3) on 31 March 2008. The patient had received initial doses of IMOVAX, IMOGAM, and tetanus vaccine (lot number and manufacturer not provided) in the emergency room on 24 March 2008, after being exposed to raccoon saliva on a cat. She received an intramuscular left deltoid second dose of IMOVAX (lot number A0259-3) on 27 March 2008, and no adverse reactions were reported at that time. In the evening of 31 March 2008, following her third dose of IMOVAX, she experienced a generalized rash, headache, sore throat, swollen lymph nodes, and a bloody nose. Treatment included BENADRYL and TYLENOL, and at the time of the report the events had not yet recovered.
Age: 18.0
Sex: F
Vaccine: RAB
Symptoms: Anger, Back pain, Confusional state, Headache
Clinical narrative: An 18-year-old female patient, who was hospitalized from 18 July 2008 to 19 July 2008 because she became confused and angry after receiving a first dose of IMOGRAM Rabies-HT and IMOVAX Rabies on 18 July 2008 for accidental exposure to a cat that was known to have rabies. These events are reported in case 2008-02453. The patient subsequently received the second dose of IMOVAX Rabies-HT (lot number, route and site of administration not provided) on 21 July 2008. An unspecified amount of time later, the patient experienced back pain and a headache. It was not reported whether the patient sought medical attention. Six days later, the patient received the third dose of IMOVAX Rabies-HT (lot number, route and site of administration not provided) and again, at an unspecified amount of time later, the patient experienced back pain and a headache. Again it was not reported whether the patient sought medical attention. At the time of this report, it was "unknown" whether the patient had recovered from the back pain and headache The reporter for this case is the same as for case 2008-02453.
Age: 59.0
Sex: F
Vaccine: RAB
Symptoms: Alopecia, Thyroid function test abnormal
Clinical narrative: Initial information was received on 01 December 2008 from a consumer. A 59 year old female patient with an allergy to penicillin received an injection of IMOVAX in August 2008 (lot number, route, and site of administration was not reported). The patient stated that she had hair loss in September 2008. The patient reported that she had the rabies vaccine series at age 12 and did not experience any reactions. She saw her doctor and thyroid testing was completed (date and results were not provided). The patient is scheduled to see a dermatologist on 09 December 2008. The recovery status was not reported. Follow-up information received on 12 February 2009 from a health care professional. On 02 September 2008 the patient received a rabies vaccine (manufacturer not reported, lot number 942320) administered in the left deltoid, rabies immunoglobin serum (lot number B1145-4 and B1123-4) administered in the bilateral glutterals and right thigh. The patient received IMOVAX on the following dates: 05 September 2008 (lot number B0182-2) right buttock intramuscularly, 09 September 2008 (lot number B0182) left deltoid intramuscularly, 16 September 2008 (lot number B0182) right buttock intramuscularly, and 30 September 2008 (lot number B0182-2) right buttock intramuscularly. The patient received  these vaccines after being bitten by a bat (date not provided). On 19 November 2008, the patient went to the doctor's and had a thyroid test completed, results were Ft4 1.17 and TSH 1.220. The date of event onset was unknown. An etiology was not determined. Recovery status was not known. List of Documents held by Sender: None.
Age: 67.0
Sex: F
Vaccine: RAB
Symptoms: Headache, Insomnia, Irritability, Swelling face
Clinical narrative: Initial non-serious case received from a patient on 05 August 2008. A 68-year-old female patient experienced headache, forehead swelling, sleeplessness and irritability on the same day after receiving an intramuscular left deltoid booster dose of IMOVAX on 29 July 2008 (lot number A0484-2, expiration date 02 August 2009) for bat exposure. The patient had received an intramuscular right deltoid tetanus vaccine (trade name, manufacturer, lot number not reported on 26 July 2008. The patient was seen by a physician on 31 July 2008 and received treatment with amoxicillin. The patient reported that she was being treated for sinus infection and ear infection at the time of the vaccination. Patient outcome was reported as 'not recovered'. The patient received a second intramuscular right deltoid booster dose of IMOVAX (lot number A0485-2, expiration date 08 June 2009) on 01 August 2008.
Age: 43.0
Sex: F
Vaccine: FLU3
Symptoms: Anaphylactic reaction
Clinical narrative: Initial information was received on 14 January 2009 from a health care professional. An unidentified patient received the Influenza virus vaccine on an unspecified date (trade name, manufacturer name, lot number, route and site not provided). After receiving the vaccine, the patient experienced an anaphylactic reaction. The date was not specified. Recovery status was not reported. When attempting to obtain further follow up, the reporter stated there was no adverse event to report, only questions pertaining to the vaccine and allergies. Follow-up information received on 27 April 2009 from a physician. It was unknown if this 43-year-old female patient had any concurrent illnesses at the time of vaccination, but it was reported she has medical conditions of allergic rhinitis, obesity and back pain; was taking concomitant medications of ZYRTEC, FLONASE and Levothyroxine (indication not reported) at the time of vaccination. The influenza vaccine was identified as FLUZONE SV 2008-2009 (lot number U2764AA); and it was administered intramuscularly on 25 November 2008 at 11:00 am. The site of administration was not reported. It was unknown how many previous doses of influenza vaccination the patient has received in the past. It was confirmed the patient experienced an anaphylactic reaction to the flu shot two hours post-vaccination on 25 November 2008 at 13:00 pm. Treatments received were not reported. The responsible physician's name and contact information was provided. The patient recovered (date not reported). Documents held by sender: None.
Age: 21.0
Sex: F
Vaccine: FLUX, HPVX, FLU3, HEPA, HPV4
Symptoms: Injected limb mobility decreased, Nuclear magnetic resonance imaging, Pain in extremity
Clinical narrative: MD reports SM c/o paresthesia 24 hours after receipt of GARDASIL #2 (pt also got influenza vac 2/6/2009 but unknown which arm received which vac). Pt c/o inability to lift right arm for 1 month with full resolution of paresthesia (?duration?). Her pain fully resolved by 4/29/2009.
Age: 21.0
Sex: F
Vaccine: FLUX, HPVX, FLU3, HEPA, HPV4
Symptoms: Injected limb mobility decreased, Nuclear magnetic resonance imaging normal, Pain, Paraesthesia, X-ray normal
Clinical narrative: MD reports SM c/o paresthesia 24 hours after receipt of GARDASIL #2 (pt also got influenza vac 2/6/2009 but unknown which arm received which vac). Pt c/o inability to lift right arm for 1 month with full resolution of paresthesia (?duration?). Her pain fully resolved by 4/29/2009.
Age: 0.2
Sex: M
Vaccine: DTAP, RV5, DTAP, RV5
Symptoms: Decreased appetite, Diarrhoea, Gastrointestinal pain, Insomnia, Irritability
Clinical narrative: A couple of days after receiving the rotavirus vaccine, my son seemed to contract it. He had a persistent low grade fever, severe stomach and intestinal pain, lose of appetite -he didn't gain any weight for 12 days, when previously he had consistently gained >1 oz per day- and explosive, voluminous, watery diarrhea at a rate 2-3x his usual bowel movement frequency. This lasted for -8 days before symptoms started to lessen, however he seems to have retained some intestinal pain.
Age: 0.2
Sex: M
Vaccine: DTAP, RV5, DTAP, RV5
Symptoms: Somnolence
Clinical narrative: A couple of days after receiving the rotavirus vaccine, my son seemed to contract it. He had a persistent low grade fever, severe stomach and intestinal pain, lose of appetite -he didn't gain any weight for 12 days, when previously he had consistently gained >1 oz per day- and explosive, voluminous, watery diarrhea at a rate 2-3x his usual bowel movement frequency. This lasted for -8 days before symptoms started to lessen, however he seems to have retained some intestinal pain.
Age: 0.2
Sex: M
Vaccine: DTAP, RV5, DTAP, RV5
Symptoms: Abdominal pain upper, Anorexia, Diarrhoea, Frequent bowel movements, Gastrointestinal pain
Clinical narrative: A couple of days after receiving the rotavirus vaccine, my son seemed to contract it. He had a persistent low grade fever, severe stomach and intestinal pain, lose of appetite -he didn't gain any weight for 12 days, when previously he had consistently gained >1 oz per day- and explosive, voluminous, watery diarrhea at a rate 2-3x his usual bowel movement frequency. This lasted for -8 days before symptoms started to lessen, however he seems to have retained some intestinal pain.
Age: 0.2
Sex: M
Vaccine: DTAP, RV5, DTAP, RV5
Symptoms: Pyrexia, Weight gain poor
Clinical narrative: A couple of days after receiving the rotavirus vaccine, my son seemed to contract it. He had a persistent low grade fever, severe stomach and intestinal pain, lose of appetite -he didn't gain any weight for 12 days, when previously he had consistently gained >1 oz per day- and explosive, voluminous, watery diarrhea at a rate 2-3x his usual bowel movement frequency. This lasted for -8 days before symptoms started to lessen, however he seems to have retained some intestinal pain.
Age: 0.2
Sex: F
Vaccine: DTAPIPVHIB, PNC, DTAPIPVHIB, PNC, DTAPIPVHIB, PNC
Symptoms: Blood culture negative, CSF culture negative, Crying, Hypotonia
Clinical narrative: Initial report received 29 April 2009 from a health care professional. An 8-week-old female infant had received a first dose of right thigh injection of PENTACEL (route not reported), lot number C3284AA and a first dose right thigh injection of PREVNAR (manufacturer Wyeth, lot number D37017, route not reported) during a well child visit on 27 April 2009, and four hours later at approximately 13:00 hours, the patient woke up from sleep, cried, went limp and stopped breathing. The patient's mother called emergency services (reported as 911) and the patient was subsequently hospitalized. CSF and blood cultures were negative to date. The patient was noted to have had rhinitis at the time of vaccination and no past medical history. The patient had not experienced any reactions following prior vaccinations and she had not received any other vaccines within four weeks of PENTACEL and PREVNAR. According to the reporter, the patient was still hospitalized at the time of the report. Her recovery status was not reported. No further information was provided at the time of the report. Documents held by sender: None.
Age: 0.2
Sex: F
Vaccine: DTAPIPVHIB, PNC, DTAPIPVHIB, PNC, DTAPIPVHIB, PNC
Symptoms: Apnoea
Clinical narrative: Initial report received 29 April 2009 from a health care professional. An 8-week-old female infant had received a first dose of right thigh injection of PENTACEL (route not reported), lot number C3284AA and a first dose right thigh injection of PREVNAR (manufacturer Wyeth, lot number D37017, route not reported) during a well child visit on 27 April 2009, and four hours later at approximately 13:00 hours, the patient woke up from sleep, cried, went limp and stopped breathing. The patient's mother called emergency services (reported as 911) and the patient was subsequently hospitalized. CSF and blood cultures were negative to date. The patient was noted to have had rhinitis at the time of vaccination and no past medical history. The patient had not experienced any reactions following prior vaccinations and she had not received any other vaccines within four weeks of PENTACEL and PREVNAR. According to the reporter, the patient was still hospitalized at the time of the report. Her recovery status was not reported. No further information was provided at the time of the report. Documents held by sender: None.
Age: 0.2
Sex: F
Vaccine: DTAPIPVHIB, PNC, DTAPIPVHIB, PNC, DTAPIPVHIB, PNC
Symptoms: Blood culture negative, CSF culture negative, Crying, Hypotonia, Respiratory arrest
Clinical narrative: Initial report received 29 April 2009 from a health care professional. An 8-week-old female infant had received a first dose of right thigh injection of PENTACEL (route not reported), lot number C3284AA and a first dose right thigh injection of PREVNAR (manufacturer Wyeth, lot number D37017, route not reported) during a well child visit on 27 April 2009, and four hours later at approximately 13:00 hours, the patient woke up from sleep, cried, went limp and stopped breathing. The patient's mother called emergency services (reported as 911) and the patient was subsequently hospitalized. CSF and blood cultures were negative to date. The patient was noted to have had rhinitis at the time of vaccination and no past medical history. The patient had not experienced any reactions following prior vaccinations and she had not received any other vaccines within four weeks of PENTACEL and PREVNAR. According to the reporter, the patient was still hospitalized at the time of the report. Her recovery status was not reported. No further information was provided at the time of the report. Documents held by sender: None.
Age: 0.5
Sex: F
Vaccine: PNC, PNC
Symptoms: Haematemesis
Clinical narrative: This case was considered medically important. Information regarding PREVNAR was received from a healthcare professional regarding a 4-month-old female patient who vomited blood. At 4 months of age, the patient received the second on 30-Apr-2009. On 30-Apr-2009, the patient was administered the second PREVNAR. The patient vomited blood two to three times within 24 hours. The patient then recovered (2009). No additional information was available at the time of this report.
Age: 0.5
Sex: F
Vaccine: PNC, PNC
Symptoms: Haematemesis, Vaccine positive rechallenge
Clinical narrative: This case was considered medically important. Information regarding PREVNAR was received from a healthcare professional regarding a 4-month-old female patient who vomited blood. At 4 months of age, the patient received the second on 30-Apr-2009. On 30-Apr-2009, the patient was administered the second PREVNAR. The patient vomited blood two to three times within 24 hours. The patient then recovered (2009). No additional information was available at the time of this report.
Age: 15.0
Sex: F
Vaccine: HPV4
Symptoms: Convulsion
Clinical narrative: Information has been received from a consumer concerning her friend's 15 year old daughter who was vaccinated with two doses of GARDASIL. After getting two doses of GARDASIL the patient experienced seizures. Upon internal review, seizures was determined to be an other important medical event. No further information was available.
Age: 23.0
Sex: F
Vaccine: HPV4
Symptoms: Drug exposure during pregnancy, Ectopic pregnancy
Clinical narrative: Information has been received from a pharmacist concerning a 23 year old female who on 08-FEB-2008 was vaccinated with her second dose of GARDASIL. The pharmacist reported on 12-FEB-2008, that the patient subsequently learned she was pregnant. The patient did not seek medical attention. No adverse reactions were reported. Follow-up information was received from a staff in the office and the registered pharmacist. The staff in the office reported that the patient had a tubal pregnancy in approximately February 2008 and "it had nothing to do with the GARDASIL". The registered pharmacist reported that she had received a request for the office for the third dose of GARDASIL for the patient in April 2008. The request note said that the patient was not pregnant at that time. The registered pharmacist had no any more information about the pregnancy. Upon internal review, tubal pregnancy was determined to be an other important medical event. No further information is available.
Sex: M
Vaccine: HEP, MEA, RUB
Symptoms: Alopecia, Pyrexia
Clinical narrative: Information has been received from a consumer concerning her son with neutropenia, who when vaccinated with any vaccine including RECOMBIVAX HB (manufacturer unknown) received as an infant, ATTENUVAX and MERUVAX II received on unspecified dates, made him developed a fever. The consumer also reported that when her son had received an unspecified vaccine on an unspecified date, he experienced hair loss and a high fever that required hospitalization. No further information is available.
Age: 57.0
Sex: F
Vaccine: TDAP
Symptoms: Dysphonia, Oedema peripheral, Pain in extremity, Pharyngeal oedema, Tenderness
Clinical narrative: This serious case was received on 30 April 2009 from a health care professional.  A 57 year old (corrected on 05 May 2009) female patient with high blood pressure received ADACEL and TUBERSOL (lot number not known) on 21 April 2009 at 2:00 PM.  ON 22 April 2009 the patient reported a painful arm which was swollen under the armpit with tenderness.  The patient used warm compresses and MOTRIN but the pain persisted.  The patient's voice became hoarse and she developed a swollen throat at that time.  The patient saw an ear, nose, and throat physician on 25 April 2009.  She was put on an antihistamine and AVOLEX.  The patient's recovery status was unknown at the time of the report.  List of Documents held by Sender:  none.
Sex: U
Vaccine: DTAP
Symptoms: Induration, Oedema, Swelling
Clinical narrative: This case was received on 01 May 2009, via another manufacturer (document number 956545). The event occurred to a subject enrolled in a study. A child received a diphtheria/tetanus toxoids/acellular pertussis vaccine (manufacturer and lot not reported), and experienced severe edema/swelling/induration during study week 4. The reporter assessed the event as definitely related to the vaccine. The subject also experienced another serious adverse event while enrolled in this study, which is captured in case number 2009-01941.
Age: 0.2
Sex: F
Vaccine: DTAPHEPBIP, HIBV, PNC
Symptoms: Haematemesis
Clinical narrative: Information regarding PREVNAR was received from a healthcare professional regarding a 2-month-old female patient who vomited blood. The patient received the first dose on 15-JAN-2009. The patient also received a dose of PEDIARIX (GlaxoSmithKline) and Haemophilus B Conjugate Vaccine (Tetanus) on 15-JAN-2009. On 15-JAN-2009, the patient was administered the PREVNAR vaccine. The patient vomited blood two to three times within 24 hours. The patient then recovered (Jan-2009). No additional information was available at the time of this report. See related case(s): US-WYE-H09237509 for the same event that happened after the second dose of PREVNAR.
Age: 3.0
Sex: F
Vaccine: PNC
Symptoms: Chills, Pyrexia, Vomiting
Clinical narrative: 4/28 had fever with chills - arm swollen 4/30 threw up.
Age: 12.0
Sex: F
Vaccine: HEPA, HPV4
Symptoms: Abdomen scan normal, Abdominal pain, Dizziness, Migraine, Nuclear magnetic resonance imaging brain normal
Clinical narrative: Daily severe migraine headache unresponsive to prescription meds.  Onset 10/08.  Abdominal pain and some dizziness.  Treated by pediatrician and neurologist.  5/18/09 MR received from PCP including vax rec.  HPV#1 8/20/2007 1060U. HPV#2 11/12/07 1265U with Hep A #1 1258U.  HPV#3 7/14/08 1279X with Hep A #2 AHAVB284DA. OV 11/21/07 with c/o H/A, upset stomach x 5 days. Dx:  Viral syndrome.  Otitis externa and OM 12/2007. Multiple OVs for H/A, sore throat, fatigue and malaise.  By 10/2008 H/As are more persistant and not responsive to meds. Assess:  Sinusitis. Pt reports not sleeping well. Getting PT for H/As. By 2/2009 c/o transverse mid-abdominal pain with now daily H/A. Assess:  H/A. Abdominal Pain. Now seeing neuro.  Neuro consults dated 12/30/08 to 5/4/09 with impression Primary Headache Syndrome with new daily persistant Headache.  H/A constant since 10/2008 which consist of painful pressure with phonophobia and difficulty concentrating. Had to quit swimming 2' to H/A and has missed many days of school. Multiple meds ineffective. 31# weight loss. Getting Accupressure.
Age: 12.0
Sex: F
Vaccine: HEPA, HPV4
Symptoms: Scan
Clinical narrative: Daily severe migraine headache unresponsive to prescription meds.  Onset 10/08.  Abdominal pain and some dizziness.  Treated by pediatrician and neurologist.  5/18/09 MR received from PCP including vax rec.  HPV#1 8/20/2007 1060U. HPV#2 11/12/07 1265U with Hep A #1 1258U.  HPV#3 7/14/08 1279X with Hep A #2 AHAVB284DA. OV 11/21/07 with c/o H/A, upset stomach x 5 days. Dx:  Viral syndrome.  Otitis externa and OM 12/2007. Multiple OVs for H/A, sore throat, fatigue and malaise.  By 10/2008 H/As are more persistant and not responsive to meds. Assess:  Sinusitis. Pt reports not sleeping well. Getting PT for H/As. By 2/2009 c/o transverse mid-abdominal pain with now daily H/A. Assess:  H/A. Abdominal Pain. Now seeing neuro.  Neuro consults dated 12/30/08 to 5/4/09 with impression Primary Headache Syndrome with new daily persistant Headache.  H/A constant since 10/2008 which consist of painful pressure with phonophobia and difficulty concentrating. Had to quit swimming 2' to H/A and has missed many days of school. Multiple meds ineffective. 31# weight loss. Getting Accupressure.
Age: 5.0
Sex: M
Vaccine: DTAP, HEPA, IPV, MMR
Symptoms: Injection site erythema, Injection site pain, Injection site swelling, Injection site warmth
Clinical narrative: On 4/28/09 Mom called on her son who had shots on 4/27/09.  His left leg is sore, red and hot today.  I told mom to put ice on his leg and have him use his leg alot today.  I asked her to let us know if it doesn't get any better.  He got DTAP and IPV in his left leg.  On 4/30/09 I called mom to see how pt was doing.  She stated they took him to the E.R.   On 4/28/09 that night because the swelling was getting worse it  had spread to his knee.  The E.R. Dr. told her it might be an allergic reaction or an infection.  He was given Benadryl at the hosp.  and a RX for an antibiotic.  Mom never filled the RX for the antibiotic because the Benadryl is helping alot.  The swelling is down and he is feeling better.
Age: 70.0
Sex: F
Vaccine: FLU3
Symptoms: Dermatologic examination abnormal, Rash generalised, Reaction to preservatives, Vaccination complication
Clinical narrative: 5 days after flu shot, I developed a rash.  This rash was all over my body except my face.  The dr's that treated me were dermatologist, family dr.,  Allergist, dermatologist. dermatopathology.  Report 11-20-08 reaction to flu vaccine (THIMEROSAL) Rash lasted 6 months
Age: 2.0
Sex: M
Vaccine: DTAP, HEPA
Clinical narrative: Upper L arm was red/irritated no pain no fever didn't feel hot.
Age: 0.51
Sex: F
Vaccine: DTAPIPVHIB, PNC, RV5
Symptoms: Diarrhoea, Vomiting
Clinical narrative: Had ROTATEQ vaccine 4-14-09. Developed vomiting on 4-17-09 - lasting 24 hours then had 4 days of watery diarrhea. No fever. Sibling then developed same symptoms on 4-21-09. He sibling also had fever. Both children fully recovered.
Age: 3.0
Sex: M
Vaccine: DTAP, HEP, VARCEL
Symptoms: Rash generalised, Skin warm, Swelling
Clinical narrative: Rash all over body, swollen and hot.
Age: 77.0
Sex: F
Vaccine: MMR
Symptoms: Lymphadenopathy, Muscle tightness, Pyrexia
Clinical narrative: Fever up 102 for 3 days with mild posterior lymph node swelling and one left axilla, and neck tenseness gradually resolved.
Age: 20.0
Sex: F
Vaccine: HPV4, HPV4
Symptoms: Arthralgia, Back pain, Blister, Gait disturbance, Genital lesion
Clinical narrative: Patients calls the day after immunization was given c/o fever low back and B/L hip pain.  States "difficult to walk" due to pain.  Symptoms occurred (onset) at about 3 hours post immunization.  Also notes 2 blisters on labia-never had before.
Age: 20.0
Sex: F
Vaccine: HPV4, HPV4
Symptoms: Pyrexia
Clinical narrative: Patients calls the day after immunization was given c/o fever low back and B/L hip pain.  States "difficult to walk" due to pain.  Symptoms occurred (onset) at about 3 hours post immunization.  Also notes 2 blisters on labia-never had before.
Age: 20.0
Sex: F
Vaccine: HPV4, HPV4
Symptoms: Arthralgia, Back pain, Blister, Gait disturbance, Genital rash
Clinical narrative: Patients calls the day after immunization was given c/o fever low back and B/L hip pain.  States "difficult to walk" due to pain.  Symptoms occurred (onset) at about 3 hours post immunization.  Also notes 2 blisters on labia-never had before.
Age: 12.0
Sex: F
Vaccine: HEPA, VARCEL
Symptoms: Erythema, Induration, Local reaction
Clinical narrative: Localized reaction 13x26mm induration with redness.
Age: 45.0
Sex: F
Vaccine: PPV
Symptoms: Dry skin, Erythema, Oedema, Tenderness
Clinical narrative: 30 cm X 10 cm length width erythema, edema, tenderness, dryness to right arm
Age: 0.2
Sex: F
Vaccine: DTAPIPVHIB, PNC, RV5
Symptoms: Crying, Irritability
Clinical narrative: Irritability for 5 hours crying, given Tylenol with some relief.
Age: 34.0
Sex: F
Vaccine: HEP, TDAP
Symptoms: Blood creatine phosphokinase, Blood creatinine, Chills, Full blood count, Injection site haematoma
Clinical narrative: 2 days after administration of TDAP vaccine in right deltoid, patient developed severe pain and bruising at injection site with report of chills, nausea.  4 days later patient noticed swelling and bruising of her right wrist
Age: 34.0
Sex: F
Vaccine: HEP, TDAP
Symptoms: Injection site pain, Joint swelling, Nausea
Clinical narrative: 2 days after administration of TDAP vaccine in right deltoid, patient developed severe pain and bruising at injection site with report of chills, nausea.  4 days later patient noticed swelling and bruising of her right wrist
Age: 11.0
Sex: F
Vaccine: HEPA, HPV4, TDAP
Symptoms: Erythema, Induration, Oedema peripheral, Skin warm
Clinical narrative: Left upper arm red, warm to touch, swollen, indurated
Age: 63.0
Sex: F
Vaccine: TDAP
Symptoms: Fatigue, Myalgia, Pain in extremity
Clinical narrative: Arm sore, tired, muscle ache lasting 1 1/2 weeks.  No treatment.
Age: 17.0
Sex: F
Vaccine: HPV4
Symptoms: Convulsion, Depressed level of consciousness, Loss of consciousness
Clinical narrative: Mother of patient states patient received vaccine and then "slumped over in chair". Mother left room to get addional help. When mother returned to room, patient was lying on floor. Mother was told by nurse that she "had a seizure". Patient was "slow to respond and did not recognize" mom for 10 minutes post event.
Age: 52.0
Sex: M
Vaccine: HEP
Symptoms: Lacrimation increased, Ocular hyperaemia
Clinical narrative: He states Imm given in AM. The following day he woke at 6AM with bilateral eye pruritis. He notices eyelids red and whites of eye a little red. Pruritis continued constant up until today. The eye have increased watering but no vision loss. He denies nasal pruritis or congetion, denies rash or hives, denies sore throat or difficult swallow. He has no history of eczema or allergies. He has never reated to an immuniaztion in the past.
Age: 1.0
Sex: F
Vaccine: MMR, PNC, VARCEL
Symptoms: Full blood count, Irritability, Pyrexia, Urine analysis normal
Clinical narrative: EXTREME FUSSINESS AND 103 DEGREE FEVER 24 HOURS AFTER GIVEN. TREATED WITH MOTRIN.  CBC WITHIN NORMAL LIMITS AND NEGATIVE UA
Age: 1.5
Sex: M
Vaccine: MMR
Symptoms: Pyrexia, Urticaria
Clinical narrative: Fever highest 104.6, hives off and on all over body
Age: 2.0
Sex: M
Vaccine: MMR, PNC
Symptoms: Rash, Rash pruritic
Clinical narrative: 4/29/09 (Telephone consult) rash on face and back of neck, no respiratory distress per mother. Atarax q6 hours as needed. Mother instructed to schedule follow up in 4 to 5 days if rash does not resolve. 5/6/09 (Telephone consult) rash on face and neck, no respiratory distress per mother. 5/7/09 (Clinic appointment) Itchy/Irritated rash to face/neck/back/wrist. No further MMR vaccines to be given to child.
Age: 35.0
Sex: M
Vaccine: HEPAB, TDAP
Symptoms: Blister, Palatal oedema, Urticaria
Clinical narrative: Aproximately 28 hours after vaccination the patients Right forearm began to have hives on it.  The following morning approximately 42 hours after vaccination, the hives were on both forearms.  His arms began to blister.  Pt went to the ER approximately 48 hours after vaccination.  Pt complained of a swollen Uvula and the feeling of needing to continuously swallow. The Uvual was approximately twice the normal size.  Pt was administered IV Benadryl and reaction was reversed.  No allergies prior to this reaction were noted.
Age: 35.0
Sex: F
Vaccine: VARCEL
Symptoms: Blister, Injection site pruritus
Clinical narrative: Developed 5 pox blisters/spots 11 days after vaccination. No other symptoms i.e. fever. Site of injection is itchy as of today.
Age: 0.33
Sex: F
Vaccine: DTAPIPV, PNC, RV1
Symptoms: Inappropriate schedule of drug administration
Clinical narrative: Pt is only 4 months and was given vaccine that was for 5yrs and up.....
Age: 18.0
Sex: F
Vaccine: ANTH, HEPA, SMALL
Symptoms: Blood human chorionic gonadotropin positive, Drug exposure during pregnancy
Clinical narrative: SM tested negative BHCG on 30Mar2009.  SM received Anthrax and Smallpox on 2Apr2009.  SM tested positive BHCG on 4May2009.  Last Menstrual Period was 16Mar2009
Age: 1.0
Sex: M
Vaccine: HEPA, MMR, VARCEL
Symptoms: Body temperature increased, Convulsion, Drooling, Full blood count normal, Irritability
Clinical narrative: Pt rec'd vaccines at 11a.m. and returned to clinic at 1p.m. due seizure like activity as witnessed by mom.  Per mom pt began drooling, clenched jaw legs became rigid, pt was staring and unresponsive for about 4-5minutes; arrived at office with temp of 104.6 and marked irritability; was given dose of Ibuprofen and examined by MD- findings were normal neurological exam with no other sig abnormal findings besides fever and irritability.  Pt was monitored in office for approx 1 hour, then rtn'd for temp recheck at 4pm, fever had dec to 99.5 at that time after dose of Tylenol at 2:40pm.  It should also be noted that twin brother had almost identical symptoms.
Age: 1.0
Sex: M
Vaccine: HEPA, MMR, VARCEL
Symptoms: Muscle rigidity, Muscle tightness, Neurological examination normal, Staring, Unresponsive to stimuli
Clinical narrative: Pt rec'd vaccines at 11a.m. and returned to clinic at 1p.m. due seizure like activity as witnessed by mom.  Per mom pt began drooling, clenched jaw legs became rigid, pt was staring and unresponsive for about 4-5minutes; arrived at office with temp of 104.6 and marked irritability; was given dose of Ibuprofen and examined by MD- findings were normal neurological exam with no other sig abnormal findings besides fever and irritability.  Pt was monitored in office for approx 1 hour, then rtn'd for temp recheck at 4pm, fever had dec to 99.5 at that time after dose of Tylenol at 2:40pm.  It should also be noted that twin brother had almost identical symptoms.
Age: 1.0
Sex: M
Vaccine: HEPA, MMR, VARCEL
Symptoms: Body temperature increased, Full blood count
Clinical narrative: Pt rec'd vaccines at 11a.m. and returned to clinic at 1p.m. w/ twin sibling.  Upon examination pt was found to have temp of 104.3 (rectally), content, immun sites benign, normal MD exam.
Age: 11.0
Sex: M
Vaccine: DTAP, IPV, MNQ
Symptoms: Wrong drug administered
Clinical narrative: GAVE DTaP INSTEAD OF Tdap
Age: 14.0
Sex: F
Vaccine: HEPA, MNQ
Symptoms: Feeling of body temperature change, Hyperhidrosis, Local reaction, Pallor, Visual impairment
Clinical narrative: Within approximately 5-10 minutes of vaccine administration, pt. c/o momentary changes in vision, was pale and diaphoretic and vomitted.  VS as follows:  BP 90/60, AP 88 & reg, RR 20 and reg. Lungs clear, no wheezing.  No hives or rash. Injection sites right and left deltoid regions unremarkable for signs of local reaction. Sent to ER for further evaluation. Left clinic ambulatory with father and brother only c/o alternating hot and cold "flashes" and continued pallor. 17 year old brother received same immunizations (Hep A #2 and menactra) without reaction, however his menactra was a different lot number.
Age: 14.0
Sex: F
Vaccine: HEPA, MNQ
Symptoms: Vomiting
Clinical narrative: Within approximately 5-10 minutes of vaccine administration, pt. c/o momentary changes in vision, was pale and diaphoretic and vomitted.  VS as follows:  BP 90/60, AP 88 & reg, RR 20 and reg. Lungs clear, no wheezing.  No hives or rash. Injection sites right and left deltoid regions unremarkable for signs of local reaction. Sent to ER for further evaluation. Left clinic ambulatory with father and brother only c/o alternating hot and cold "flashes" and continued pallor. 17 year old brother received same immunizations (Hep A #2 and menactra) without reaction, however his menactra was a different lot number.
Age: 23.0
Sex: M
Vaccine: ANTH, SMALL, TYP, ANTH, SMALL, TYP
Symptoms: Folliculitis
Clinical narrative: Pt. w/ peri-umbilical follicultis on 2 May 09.  No tx. required.
Age: 4.0
Sex: M
Vaccine: DTAP, IPV, MMR, VARCEL
Symptoms: Injection site erythema, Injection site swelling
Clinical narrative: L arm redness and swelling 4 cm x5 cm
Age: 16.0
Sex: F
Vaccine: HPV4, MNQ, VARCEL
Symptoms: Blood glucose normal, Syncope
Clinical narrative: Pt had syncopal episode 15 min after administration of vaccines.
Age: 1.08
Sex: M
Vaccine: HEPA, HIBV, MMR, PNC, TDAP, VARCEL
Symptoms: Wrong drug administered
Clinical narrative: No adverse event reported. RN gave Tdap instead of a Dtap.