chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 0.36
Sex: F
Vaccine: DTAPHEPBIP, HIBV, PNC13, RV1
Symptoms: Polychromic red blood cells present, Pyrexia, Rash erythematous, Rash generalised, Rash maculo-papular
Clinical narrative: This female subject was enrolled in the study 112957 (HIB-097).  On 13 September 2010 and 17 November 2010 she received the 1st, 2nd dose of HIBERIX (IM R thigh), PEDIARIX (IM L thigh), PREVNAR 13 (IM L thigh or deltoid) and ROTARIX (po).  On 19 January 2011, she received a 3rd dose of HIBERIX, PEDIARIX and PREVNAR 13.  This subject received HIBERIX (lot AHIBVC292A and AD02VB365A).  On 19 January 2011, 63 days after the 2nd dose of ROTARIX, on the same day after the 3rd dose of PEDIARIX, on the same day after the 3rd dose of HIBERIX, on the same day after the 3rd dose of PREVNAR 13, this six-month-old subject developed Kawasaki disease.  The subject was hospitalised.  The subject was treated with paracetamol, intravenous fluid(s), normal immunoglobulin, diphenhydramine and aspirin.  The event improved on an unspecified date.  The investigator considered that there was a reasonable possibility that the Kawasaki disease may have been caused by ROTARIX, PEDIARIX, HIBERIX and PREVNAR 13 and that the event was possibly due to disease under study.  Investigator Comments : Subject with fever for 5 days (101-102 axillary), conjunctivitis, red lips, and body rash.  Admitted to rule out Kawasakis.  Received 6 month shots 19Jan2011- developed fever that day, rash started 22Jan2011- erythmatous, maculopapular blanching and discrete conjunctival injection developed night prior to admission.  Lips bright red but not cracked.  No hand/feet swelling or skin changes but small blanching red spots on palms and soles, no lymph adenopathy noted.  Patient started on IV fluids and acetaminophen for fever and pain.  24Jan2011 patient with swollen hands and feet, cracked lips.  Nasopharynx Swab - negative for Influenza A and B and RSV.  Patient had normal echocardiogram 26Jan2011.  Patient tolerated treatment IV immunoglobulin 24Jan2011 for Kawasakis Disease with dramatic responses with near complete resolution of rash, conjunctivitis, hand/foot changes and mucositis.  High dose Aspirin started on 25Jan2011 following negative swab for Influenza A, B and RSV.  Slight waxing/waning of rash/conjunctivial erythema/lip redness but not considered significant enough for second dose of IV immunoglobulin.  Patient afebrile for greater than 48 hours prior to discharge.  Patient discharged on 27Jan2011 on low dose Aspirin 40.5 mg a day and acetaminiophen 120 mg suppositories prn pain or fever.  28Jan2011 follow-up clinic visit exam / assessment - resolving Kawasakis, neg echo, improving appetite though weight down 7.5 ounces, resolving conjunctivitis no rash, normal extremities purulent nasal discharge and normal mouth and throat.  Repeat echocardiogram in 6 weeks.
Age: 0.36
Sex: F
Vaccine: DTAPHEPBIP, HIBV, PNC13, RV1
Symptoms: Red blood cell count normal, Red blood cell sedimentation rate increased, Red cell distribution width normal, Rhinitis, Streptococcus test negative
Clinical narrative: This female subject was enrolled in the study 112957 (HIB-097).  On 13 September 2010 and 17 November 2010 she received the 1st, 2nd dose of HIBERIX (IM R thigh), PEDIARIX (IM L thigh), PREVNAR 13 (IM L thigh or deltoid) and ROTARIX (po).  On 19 January 2011, she received a 3rd dose of HIBERIX, PEDIARIX and PREVNAR 13.  This subject received HIBERIX (lot AHIBVC292A and AD02VB365A).  On 19 January 2011, 63 days after the 2nd dose of ROTARIX, on the same day after the 3rd dose of PEDIARIX, on the same day after the 3rd dose of HIBERIX, on the same day after the 3rd dose of PREVNAR 13, this six-month-old subject developed Kawasaki disease.  The subject was hospitalised.  The subject was treated with paracetamol, intravenous fluid(s), normal immunoglobulin, diphenhydramine and aspirin.  The event improved on an unspecified date.  The investigator considered that there was a reasonable possibility that the Kawasaki disease may have been caused by ROTARIX, PEDIARIX, HIBERIX and PREVNAR 13 and that the event was possibly due to disease under study.  Investigator Comments : Subject with fever for 5 days (101-102 axillary), conjunctivitis, red lips, and body rash.  Admitted to rule out Kawasakis.  Received 6 month shots 19Jan2011- developed fever that day, rash started 22Jan2011- erythmatous, maculopapular blanching and discrete conjunctival injection developed night prior to admission.  Lips bright red but not cracked.  No hand/feet swelling or skin changes but small blanching red spots on palms and soles, no lymph adenopathy noted.  Patient started on IV fluids and acetaminophen for fever and pain.  24Jan2011 patient with swollen hands and feet, cracked lips.  Nasopharynx Swab - negative for Influenza A and B and RSV.  Patient had normal echocardiogram 26Jan2011.  Patient tolerated treatment IV immunoglobulin 24Jan2011 for Kawasakis Disease with dramatic responses with near complete resolution of rash, conjunctivitis, hand/foot changes and mucositis.  High dose Aspirin started on 25Jan2011 following negative swab for Influenza A, B and RSV.  Slight waxing/waning of rash/conjunctivial erythema/lip redness but not considered significant enough for second dose of IV immunoglobulin.  Patient afebrile for greater than 48 hours prior to discharge.  Patient discharged on 27Jan2011 on low dose Aspirin 40.5 mg a day and acetaminiophen 120 mg suppositories prn pain or fever.  28Jan2011 follow-up clinic visit exam / assessment - resolving Kawasakis, neg echo, improving appetite though weight down 7.5 ounces, resolving conjunctivitis no rash, normal extremities purulent nasal discharge and normal mouth and throat.  Repeat echocardiogram in 6 weeks.
Age: 0.36
Sex: F
Vaccine: DTAPHEPBIP, HIBV, PNC13, RV1
Symptoms: Urine analysis normal, Weight decreased, White blood cell count normal
Clinical narrative: This female subject was enrolled in the study 112957 (HIB-097).  On 13 September 2010 and 17 November 2010 she received the 1st, 2nd dose of HIBERIX (IM R thigh), PEDIARIX (IM L thigh), PREVNAR 13 (IM L thigh or deltoid) and ROTARIX (po).  On 19 January 2011, she received a 3rd dose of HIBERIX, PEDIARIX and PREVNAR 13.  This subject received HIBERIX (lot AHIBVC292A and AD02VB365A).  On 19 January 2011, 63 days after the 2nd dose of ROTARIX, on the same day after the 3rd dose of PEDIARIX, on the same day after the 3rd dose of HIBERIX, on the same day after the 3rd dose of PREVNAR 13, this six-month-old subject developed Kawasaki disease.  The subject was hospitalised.  The subject was treated with paracetamol, intravenous fluid(s), normal immunoglobulin, diphenhydramine and aspirin.  The event improved on an unspecified date.  The investigator considered that there was a reasonable possibility that the Kawasaki disease may have been caused by ROTARIX, PEDIARIX, HIBERIX and PREVNAR 13 and that the event was possibly due to disease under study.  Investigator Comments : Subject with fever for 5 days (101-102 axillary), conjunctivitis, red lips, and body rash.  Admitted to rule out Kawasakis.  Received 6 month shots 19Jan2011- developed fever that day, rash started 22Jan2011- erythmatous, maculopapular blanching and discrete conjunctival injection developed night prior to admission.  Lips bright red but not cracked.  No hand/feet swelling or skin changes but small blanching red spots on palms and soles, no lymph adenopathy noted.  Patient started on IV fluids and acetaminophen for fever and pain.  24Jan2011 patient with swollen hands and feet, cracked lips.  Nasopharynx Swab - negative for Influenza A and B and RSV.  Patient had normal echocardiogram 26Jan2011.  Patient tolerated treatment IV immunoglobulin 24Jan2011 for Kawasakis Disease with dramatic responses with near complete resolution of rash, conjunctivitis, hand/foot changes and mucositis.  High dose Aspirin started on 25Jan2011 following negative swab for Influenza A, B and RSV.  Slight waxing/waning of rash/conjunctivial erythema/lip redness but not considered significant enough for second dose of IV immunoglobulin.  Patient afebrile for greater than 48 hours prior to discharge.  Patient discharged on 27Jan2011 on low dose Aspirin 40.5 mg a day and acetaminiophen 120 mg suppositories prn pain or fever.  28Jan2011 follow-up clinic visit exam / assessment - resolving Kawasakis, neg echo, improving appetite though weight down 7.5 ounces, resolving conjunctivitis no rash, normal extremities purulent nasal discharge and normal mouth and throat.  Repeat echocardiogram in 6 weeks.
Age: 89.0
Sex: M
Vaccine: TD
Symptoms: Blood pressure immeasurable, Dysarthria, Laboratory test normal, Tachycardia
Clinical narrative: Caregiver expressed that patient developed tachycardia, slurred speech, and unable to get BP about 1 1/2 hrs after vaccine was administered.
Age: 1.0
Sex: F
Vaccine: HEPA, HIBV, MMR, PNC13, VARCEL
Symptoms: Decreased appetite, Insomnia, Pyrexia, Rash
Clinical narrative: Fever of 101-102F, loss of appetite, bumps on abdomen worsening, difficulty sleeping.
Age: 3.0
Sex: M
Vaccine: FLU3
Symptoms: Convulsion
Clinical narrative: Seizure.
Age: 19.0
Sex: F
Vaccine: FLU3
Symptoms: Hypoaesthesia, Injection site swelling, Pain in extremity
Clinical narrative: Raised, swollen area around injection site (right arm), pain and numb feeling in arm.
Age: 62.0
Sex: M
Vaccine: FLU3
Symptoms: Chest X-ray normal, Herpes zoster, Muscle spasms, Pain, Rash
Clinical narrative: The onset of a Acute Herpes Zoster/Shingles.
Age: 1.13
Sex: M
Vaccine: HEPA, HIBV, MMR, PNC13, VARCEL
Symptoms: Injection site erythema, Injection site mass
Clinical narrative: golf sized red lump on left thigh where varicella was given
Age: 5.0
Sex: F
Vaccine: DTAPIPV, HEPA, MMR, VARCEL
Symptoms: Injection site cellulitis, Injection site erythema, Injection site swelling, Injection site warmth, Red man syndrome
Clinical narrative: Initially noticed redness and swelling of her right upper arm. Symptoms continued to increase despite cool compresses and Tylenol. Developed warmth and spreading erythema down below elbow. Patient taken to ER on 1/26/11 to be evaluated and decision was made that patient had celluliltis and needed IV antibiotics. Decision was made to give IV Vancomycin and patient subsequently developed redman's syndrome. Patient was transferred to another Hospital and started on IV clindamycin and admitted overnight. Patient was sent home with 7 days of po clindamycin. Patient was seen in the office for follow up on 1/28/11 and erythema and swelling were resolving well.
Age: 50.0
Sex: M
Vaccine: ANTH, HEP, HEPA
Symptoms: Arthralgia, Fatigue, Injection site inflammation, Injection site swelling
Clinical narrative: Joint pain, extreme fatigue.
Age: 56.0
Sex: F
Vaccine: FLUX, FLU3
Symptoms: Immediate post-injection reaction, Pain, Pain in extremity
Clinical narrative: As soon as I received the shot it hurt inside my arm. It has become progressively worse and really hurts to raise my arms over my head. I am constantly in pain.
Age: 56.0
Sex: F
Vaccine: FLUX, FLU3
Symptoms: Pain in extremity
Clinical narrative: As soon as I received the shot it hurt inside my arm. It has become progressively worse and really hurts to raise my arms over my head. I am constantly in pain.
Age: 4.0
Sex: M
Vaccine: DTAP, IPV, MMR, VARCEL
Symptoms: Injection site erythema
Clinical narrative: Mom notified me of erythema of approximately 3 in-4 in around site of DTAP injection.
Age: 17.0
Sex: F
Vaccine: HPV4, TDAP
Symptoms: Electroencephalogram abnormal, Grand mal convulsion, Laboratory test abnormal, Nuclear magnetic resonance imaging abnormal
Clinical narrative: Witnessed tonic clonic seizure.
Age: 18.0
Sex: F
Vaccine: HPV4
Symptoms: Condition aggravated, Convulsion
Clinical narrative: (1) Unwitnessed seizure. Found down on bedroom floor by parents. (2) Second seizure since 1st on 10.30.2010. Pt now began on LAMICTAL.
Age: 13.0
Sex: F
Vaccine: FLUN3, MNQ, TDAP, VARCEL
Symptoms: Injection site erythema, Injection site induration, Injection site swelling, Varicella
Clinical narrative: On 1/31/2011 received vaccines Varicella, TDAP, Meningitis, seasonal FLUMIST - Mom reported child had chickenpox disease & was req. by school to have vaccine. Lt. upper arm, swollen & reddened size of golf ball hard swelling.
Age: 1.23
Sex: F
Vaccine: DTAP, HIBV
Symptoms: Injection site erythema, Injection site swelling, Injection site warmth, Rash pruritic
Clinical narrative: Swelling, warmth, redness at injection site itching rash, possible cellulitis.
Age: 4.0
Sex: M
Vaccine: DTAP, IPV, MMR, VARCEL
Symptoms: Injection site erythema, Injection site induration, Injection site pain, Injection site swelling
Clinical narrative: 6 cm hard, swollen, red area on left thigh (painful). Tx: CEPHALEXIN 250mg/5ml - 4 ml po BID x 10 Naproxen susp 125mg/5ml - 1/2 tsp po Q12H x 20 days ORAPRED susp 15mg/5ml - 3/4 tsp BID x 5 days.
Age: 1.26
Sex: F
Vaccine: DTAP, FLU3, HIBV
Symptoms: Febrile convulsion, Pyrexia
Clinical narrative: Within 24 hours pt had fever 104 degrees F and febrile seizure with no found source of fever.
Age: 0.21
Sex: F
Vaccine: DTAPIPVHIB, HEP, PNC13, RV1
Symptoms: Diarrhoea, Intussusception, Lethargy, Surgery, Vomiting
Clinical narrative: GM states baby became ill 1/24/11 with vom., diarrhea, lethargy, etc. Took to ER then transferred to another hospital. Admitted. Underwent bowel surgery for intussusception.
Age: 7.0
Sex: M
Vaccine: MEA
Symptoms: Disturbance in attention, Pneumonia, Tic
Clinical narrative: Information has been received from a consumer concerning her son a 7 year old male with seasonal allergy and no drug reactions/allergies who was vaccinated with a dose of ATTENUVAX (lot # not provided) on an unspecified date. Subsequently the patient came down with pneumonia. At the time of the report, the outcome was unknown. The patient had developed a tic and disturbance in attention while on therapy with rubella virus vaccine (MSD, WAES # 1002USA02312). Additional information has been requested.
Age: 2.0
Sex: F
Vaccine: MEA
Symptoms: Pneumonia, Pyrexia, Rash
Clinical narrative: Information has been received from a consumer concerning her 24 month old daughter with a history of hives while on prior therapy with rubella virus vaccine (MSD, WAES# 1001USA02979) who on an unspecified date was vaccinated with a dose of ATTENUVAX. Subsequently the patient experienced rash and high fever. At the time of the report, the patient's outcome was unknown. The patient subsequently experienced pneumonia while on therapy with VARIVAX (Merck) (MSD, WAES# 1001USA01886). This is one of several reports from the same source. Additional information has been requested.
Age: 50.0
Sex: F
Vaccine: PPV
Symptoms: Injection site erythema, Injection site pain, Injection site reaction, Injection site swelling, Insomnia
Clinical narrative: Information has been received from a Nurse concerning a 50 year old female patient who on 15-NOV-2010 was vaccinated with her first dose of PNEUMOVAX 23 IM on the left deltoid (lot # 667416/0956Z). Subsequently the patient developed an "injection site reaction". She developed a small red blotchy area, increased soreness, redness, swelling, a fever, nausea and had difficulty sleeping. The reaction went from her shoulder to elbow. She came into office and was given 1 gram of ROCEPHIN. On 18-NOV-2010 she went to the Emergency Department of a hospital and was admitted overnight to the hospital and given ANCEF and was discharged on amoxicillin. On 22-NOV-2010 the patient came into office and was told to finish her course of antibiotics. On 26-NOV-2010 she called the office and said her arm was still sore. All the events were considered to be other important medical events by the nurse. This is one of several reports received from the same source. Additional information has been requested.
Age: 50.0
Sex: F
Vaccine: PPV
Symptoms: Nausea, Pain in extremity, Pyrexia, Rash macular
Clinical narrative: Information has been received from a Nurse concerning a 50 year old female patient who on 15-NOV-2010 was vaccinated with her first dose of PNEUMOVAX 23 IM on the left deltoid (lot # 667416/0956Z). Subsequently the patient developed an "injection site reaction". She developed a small red blotchy area, increased soreness, redness, swelling, a fever, nausea and had difficulty sleeping. The reaction went from her shoulder to elbow. She came into office and was given 1 gram of ROCEPHIN. On 18-NOV-2010 she went to the Emergency Department of a hospital and was admitted overnight to the hospital and given ANCEF and was discharged on amoxicillin. On 22-NOV-2010 the patient came into office and was told to finish her course of antibiotics. On 26-NOV-2010 she called the office and said her arm was still sore. All the events were considered to be other important medical events by the nurse. This is one of several reports received from the same source. Additional information has been requested.
Age: 3.0
Sex: F
Vaccine: MEA
Symptoms: Urticaria
Clinical narrative: Information has been received from a registered nurse concerning a 36 month old female with no pertinent medical history and no known drug allergies, who on 15-JUN-2007 was vaccinated with a dose of ATTENUVAX (lot # 654623/0667F). There was no concomitant medication. On 16-JUN-2007 the patient developed hives all over her body within 24 hours of administration. There were no labs and diagnostic tests performed. The patient made a phone call for medical attention. On an unknown date, the patient recovered. Information has been received from a registered nurse concerning a 36 month old female with no pertinent medical history and no known drug allergies, who on 15-JUN-2007 was vaccinated with the first dose of ATTENUVAX (lot # 654623/0667F) in the left arm. On 15-JUN-2007 the patient developed hives after injection within 24 hours. There were no labs or diagnostic tests performed. The patient recovered at the time of the report. No further information is available. The patient subsequently experienced hives all over her body while on therapy with rubella virus vaccine (MSD, WAES # 0912USA02093).
Age: 17.0
Sex: F
Vaccine: MEN, MNQ, MNQ
Symptoms: Convulsion, Hypersomnia
Clinical narrative: Initial report received from a health care professional on 26 January 2011, under temporary VAERS e-report number E-51550.  A 17-year-old female patient received an intramuscular left deltoid injection of MENACTRA (lot number U3355BA) on 18 January 2011, and an injection of DECAVAC (lot number reported as 3059, not a complete sanofi pasteur lot number) on 07 January 2011.  Three days post-vaccination with MENACTRA, on 21 January 2011, the patient experienced a seizure.  According to the reporter, the patient had previously experienced seizures 3 days post-vaccination following her first and second doses of GARDASIL (lot not reported).  GARDASIL had been administered in February 2010, and the patient had been taking anti-seizure medication that time.  The patient was scheduled for an EEG, and was following up with a neurologist due to ongoing complaints of lethargy.  Per the reporter, the patient "may be having small seizures".  The event of seizure was reported to be recovered, although the patient continued to have ongoing lethargy.  Documents held by sender: None.
Age: 17.0
Sex: F
Vaccine: MEN, MNQ, MNQ
Symptoms: Condition aggravated, Convulsion
Clinical narrative: Initial report received from a health care professional on 26 January 2011, under temporary VAERS e-report number E-51550.  A 17-year-old female patient received an intramuscular left deltoid injection of MENACTRA (lot number U3355BA) on 18 January 2011, and an injection of DECAVAC (lot number reported as 3059, not a complete sanofi pasteur lot number) on 07 January 2011.  Three days post-vaccination with MENACTRA, on 21 January 2011, the patient experienced a seizure.  According to the reporter, the patient had previously experienced seizures 3 days post-vaccination following her first and second doses of GARDASIL (lot not reported).  GARDASIL had been administered in February 2010, and the patient had been taking anti-seizure medication that time.  The patient was scheduled for an EEG, and was following up with a neurologist due to ongoing complaints of lethargy.  Per the reporter, the patient "may be having small seizures".  The event of seizure was reported to be recovered, although the patient continued to have ongoing lethargy.  Documents held by sender: None.
Age: 17.0
Sex: F
Vaccine: MEN, MNQ, MNQ
Symptoms: Condition aggravated, Convulsion, Lethargy, Vaccine positive rechallenge
Clinical narrative: Initial report received from a health care professional on 26 January 2011, under temporary VAERS e-report number E-51550.  A 17-year-old female patient received an intramuscular left deltoid injection of MENACTRA (lot number U3355BA) on 18 January 2011, and an injection of DECAVAC (lot number reported as 3059, not a complete sanofi pasteur lot number) on 07 January 2011.  Three days post-vaccination with MENACTRA, on 21 January 2011, the patient experienced a seizure.  According to the reporter, the patient had previously experienced seizures 3 days post-vaccination following her first and second doses of GARDASIL (lot not reported).  GARDASIL had been administered in February 2010, and the patient had been taking anti-seizure medication that time.  The patient was scheduled for an EEG, and was following up with a neurologist due to ongoing complaints of lethargy.  Per the reporter, the patient "may be having small seizures".  The event of seizure was reported to be recovered, although the patient continued to have ongoing lethargy.  Documents held by sender: None.
Age: 77.0
Sex: M
Vaccine: PPV
Symptoms: Injection site erythema, Injection site mass, Injection site pain, Injection site swelling
Clinical narrative: Approximately 2 hrs after shot; pt developed red, raised, painful lump at injection site. Overnight pt says it remained swollen, red, and painful, and looks like it has "fluid inside". Referred pt to local urgent care.
Age: 76.0
Sex: F
Vaccine: VARZOS
Symptoms: Allergy test positive, Anaphylactic reaction, Blood immunoglobulin E increased, Blood test normal, Glucosylceramide
Clinical narrative: 20 minutes after ZOSTAVAX - Anaphylaxis. EMT transport to hospital overnight observation.
Age: 45.0
Sex: F
Vaccine: TTOX
Symptoms: Chills, Injection site erythema, Injection site swelling, Muscle spasms, Myalgia
Clinical narrative: Chills, painful muscles spasms in arm, redness and swelling at injection site
Age: 12.0
Sex: F
Vaccine: FLUX, HPV4
Symptoms: Pain, Pain in extremity
Clinical narrative: Information has been received from a physician concerning a 12 year old female patient with asthma who on 28-SEP-2010 was vaccinated with a first dose of GARDASIL (Lot # not reported). Concomitant therapy given on the same day included a INFLUENZA vaccine (unspecified). The physician stated that the patient came to his office on 25-OCT-2010 with systemic right side pain down to her legs and was admitted to an unspecified hospital for three days, where upon discharge symptoms resided. It was also reported that on 28-OCT-2010 the patient recovered from all these symptoms and the sequence of GARDASIL was discontinued, after the first dose was administered. Additional information has been requested.
Age: 18.0
Sex: F
Vaccine: HPV4
Symptoms: Biopsy bone marrow, Blood test, Central venous catheterisation, Chemotherapy, Chest X-ray
Clinical narrative: Information has been received from the Aunt of an 18 year old female consumer who on an unspecified date was vaccinated, IM with a dose of GARDASIL (dosage not provided) for the prevention of cervical cancer. It was reported that, on an unspecified date, the patient "developed an enlarged lymph node on the left side, supra clavicular, which was diagnosed as infected lymph node at first. She was given an antibiotic. But later went to the ER and found out she had cancer stage 3 Hodgkins lymphoma type D. It was a 3cm lymph node from the right axilla", requiring chemo, portacath and bone marrow biopsy. It was reported the patient also had a chest x-ray, cat scan w/ contrast, a PETscan, blood work and had an ovary removed to harvest an egg. At the time of the report, the patient had not recovered. Upon internal review, cancer stage 3 Hodgkins lymphoma type D was determined to be an other important medical event. Additional information is expected.
Age: 18.0
Sex: F
Vaccine: HPV4
Symptoms: Computerised tomogram, Hodgkin's disease, Lymphadenopathy, Oophorectomy, Positron emission tomogram
Clinical narrative: Information has been received from the Aunt of an 18 year old female consumer who on an unspecified date was vaccinated, IM with a dose of GARDASIL (dosage not provided) for the prevention of cervical cancer. It was reported that, on an unspecified date, the patient "developed an enlarged lymph node on the left side, supra clavicular, which was diagnosed as infected lymph node at first. She was given an antibiotic. But later went to the ER and found out she had cancer stage 3 Hodgkins lymphoma type D. It was a 3cm lymph node from the right axilla", requiring chemo, portacath and bone marrow biopsy. It was reported the patient also had a chest x-ray, cat scan w/ contrast, a PETscan, blood work and had an ovary removed to harvest an egg. At the time of the report, the patient had not recovered. Upon internal review, cancer stage 3 Hodgkins lymphoma type D was determined to be an other important medical event. Additional information is expected.
Age: 18.0
Sex: F
Vaccine: HPV4
Symptoms: Scan with contrast
Clinical narrative: Information has been received from the Aunt of an 18 year old female consumer who on an unspecified date was vaccinated, IM with a dose of GARDASIL (dosage not provided) for the prevention of cervical cancer. It was reported that, on an unspecified date, the patient "developed an enlarged lymph node on the left side, supra clavicular, which was diagnosed as infected lymph node at first. She was given an antibiotic. But later went to the ER and found out she had cancer stage 3 Hodgkins lymphoma type D. It was a 3cm lymph node from the right axilla", requiring chemo, portacath and bone marrow biopsy. It was reported the patient also had a chest x-ray, cat scan w/ contrast, a PETscan, blood work and had an ovary removed to harvest an egg. At the time of the report, the patient had not recovered. Upon internal review, cancer stage 3 Hodgkins lymphoma type D was determined to be an other important medical event. Additional information is expected.
Age: 4.0
Sex: M
Vaccine: DTAP, HEP, HIBV, MMR, VARCEL
Symptoms: Chills, Vomiting
Clinical narrative: Sleeping, and started vomiting and shivering. Checked temp, and gave a warm shower. Went back to sleep and vomited again. Gave a small cup of water, went back to sleep and vomited again at 8 am.
Age: 45.0
Sex: F
Vaccine: PPV
Symptoms: Injection site erythema, Injection site pain, Injection site swelling
Clinical narrative: Patient received PPV23 01/26/2011 at approx 1:30 PM.  States not too long after she got home area swelled up and became painful and red.  Relates redness and swelling lasted 4 days, and after 6 days still has some soreness but other symptoms are gone.  Pt had taken Benadryl and Tylenol when she had symptoms.  Did not seek medical attention, just called a clinic employee at home.
Age: 1.0
Sex: F
Vaccine: DTAPIPVHIB, HEPA, MMR, PNC, VARCEL
Symptoms: Cyanosis central, Feeling hot, Gaze palsy, Hypoventilation, Pyrexia
Clinical narrative: Received immis at 0930 AM 121510. At 1900 pm same day adverse reaction began. Feet warm to touch but did not take temp. Father found child on floor with eyes rolled back breathing shallow, face was blue. Went to ER-Dr. Had fever of 103.6. Gave her MOTRIN at ER - sent child home. Fever broke next day. Released from ER at 10-10:30 PM.
Age: 82.0
Sex: F
Vaccine: FLU3
Symptoms: Abscess drainage, Abscess limb, Activities of daily living impaired, Inflammation, Mobility decreased
Clinical narrative: 10-5-10 received flu vaccine. 10-06-10 developed abscess & limited painful movement in arm. 10-07-10 drained abscess by Dr. Still limited & painful movement not able to achieve normal tasks & movement 10-11-10 revisited Dr more fluid developed in arm. 1-27-11 revisited Dr due to inflammation & pain was referred to orthopedic Dr.
Age: 82.0
Sex: F
Vaccine: FLU3
Symptoms: Pain
Clinical narrative: 10-5-10 received flu vaccine. 10-06-10 developed abscess & limited painful movement in arm. 10-07-10 drained abscess by Dr. Still limited & painful movement not able to achieve normal tasks & movement 10-11-10 revisited Dr more fluid developed in arm. 1-27-11 revisited Dr due to inflammation & pain was referred to orthopedic Dr.
Age: 1.05
Sex: M
Vaccine: HEPA, PNC, VARCEL
Symptoms: Febrile convulsion, Full blood count abnormal, Influenza A virus test negative, Metabolic function test, Otitis media
Clinical narrative: Pt in ER 1/24/11 diagnosed with febrile seizure. In office 1/28/11 noted to have (R) OM.
Age: 1.05
Sex: M
Vaccine: HEPA, PNC, VARCEL
Symptoms: Respiratory syncytial virus test negative
Clinical narrative: Pt in ER 1/24/11 diagnosed with febrile seizure. In office 1/28/11 noted to have (R) OM.
Age: 1.01
Sex: F
Vaccine: FLU3, PNC, VARCEL
Symptoms: Rash papular, Skin lesion, Varicella
Clinical narrative: Scattered papular lesions on trunk/exts some with whitish/yellowish fluid, none with eschar yet, different sizes, blanch chickenpox.
Age: 58.0
Sex: F
Vaccine: HEP
Symptoms: Wrong drug administered
Clinical narrative: Patient called to schedule her third Hepatitis B vaccine and a Hepatitis B vaccine was pulled and put into a bag for the patient. When the patient arrived the ENGERIX-B vaccine was pulled from the bag and administered to the patient. Later it was found out that the patient was supposed to receive the TWINRIX not the ENGERIX-B because she needed her third shot for the Hepatitis A & B combination product, not just the hepatitis B vaccine.
Age: 1.25
Sex: M
Vaccine: DTAPIPVHIB, FLU3, PNC13
Symptoms: Oedema peripheral, Pain in extremity
Clinical narrative: Swelling, painful sore (L) upper arm.
Age: 0.55
Sex: F
Vaccine: DTAPIPVHIB, FLU3, PNC, RV5
Symptoms: Febrile convulsion, Laboratory test normal
Clinical narrative: Febrile Seizure
Age: 16.0
Sex: F
Vaccine: HPV4
Symptoms: Crying, Nuclear magnetic resonance imaging, Pain in extremity
Clinical narrative: Severe pain on left arm. Patient was crying uncontrollably that mother had to call 911 and take her by EMS. However, records from the hospital ER where she was treated did not reflect the magnitute of symptoms mother was describing. She was discharged on Motrin for pain only.
Age: 60.0
Sex: F
Vaccine: VARZOS
Symptoms: Herpes zoster
Clinical narrative: 3 years after ZOSTAVAX came down with shingles.
Age: 11.0
Sex: F
Vaccine: HPV4, MNQ, TDAP
Symptoms: Injection site erythema, Injection site swelling
Clinical narrative: (R) local deltoid swelling with erythema onset yesterday 1/19/11 vax given 1/18/11.
Age: 67.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site erythema, Injection site rash, Injection site scab, Injection site scar, Injection site swelling
Clinical narrative: Three days after administration patient presented with a red, warm & swollen rash on and around the area of administration. Within the week had blistered, pt visited MD received KEFLEX rx and is now recovering with minor scarring from the scab.
Age: 67.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site vesicles, Injection site warmth
Clinical narrative: Three days after administration patient presented with a red, warm & swollen rash on and around the area of administration. Within the week had blistered, pt visited MD received KEFLEX rx and is now recovering with minor scarring from the scab.
Age: 25.0
Sex: F
Vaccine: HEPAB
Symptoms: Dizziness, Hyperhidrosis, Immediate post-injection reaction, Loss of consciousness, Nausea
Clinical narrative: CLIENT PASSED OUT IMMEDIATLEY AFTER INJECTION PALE DIAPHORETIC 20 MINS LATER SAT UP SLOWLY BUT STILL FELT FAINT B.P 124/84 PULSE 88 TOOK SIPS OF WATER HAD HER LIE BACK DOWN CLIENT SAT UP SLOWLY AGAIN AT 2:26PM COLOR STARTED TO RETURN AT 2:35 CLIENT STATED SHE FELT MUCH BETTER BUT STILL NAUSEOUS STATED HAD LUNCH AND FLUIDS AT NOON TIME CONTINUED TO GIVE SIPS OF WATER BP 120/80 PULSE 84 WHEN FELT FRESH AIR NAUSEA DISAPPEARED LEFT FEELING BETTER AT 2:45 PM STAFF PREVENTED ANY INJURY STATED SHE FAINTS EVERYTIME SHE GETS A SHOT BUT DIDNT NOTIFY STAFF UNTILL AFTER INJECTION WAS GIVEN CLIENT WAS ADVISED TO NOT TO RECIEVE ANY FURTHER VACCINATIONS FROM OUR CLINIC BUT TO SEE HER PRIMARY CARE PHYSICIAN
Age: 25.0
Sex: F
Vaccine: HEPAB
Symptoms: Pallor
Clinical narrative: CLIENT PASSED OUT IMMEDIATLEY AFTER INJECTION PALE DIAPHORETIC 20 MINS LATER SAT UP SLOWLY BUT STILL FELT FAINT B.P 124/84 PULSE 88 TOOK SIPS OF WATER HAD HER LIE BACK DOWN CLIENT SAT UP SLOWLY AGAIN AT 2:26PM COLOR STARTED TO RETURN AT 2:35 CLIENT STATED SHE FELT MUCH BETTER BUT STILL NAUSEOUS STATED HAD LUNCH AND FLUIDS AT NOON TIME CONTINUED TO GIVE SIPS OF WATER BP 120/80 PULSE 84 WHEN FELT FRESH AIR NAUSEA DISAPPEARED LEFT FEELING BETTER AT 2:45 PM STAFF PREVENTED ANY INJURY STATED SHE FAINTS EVERYTIME SHE GETS A SHOT BUT DIDNT NOTIFY STAFF UNTILL AFTER INJECTION WAS GIVEN CLIENT WAS ADVISED TO NOT TO RECIEVE ANY FURTHER VACCINATIONS FROM OUR CLINIC BUT TO SEE HER PRIMARY CARE PHYSICIAN
Age: 18.0
Sex: M
Vaccine: MNQ
Symptoms: CSF culture positive, Death, Endotracheal intubation, Gram stain, Hypoaesthesia
Clinical narrative: Non-specific symptoms began 1/12/2011, progressed to rash, fever, numbness in arms/legs 1/13. Taken to Emergency Department, experienced blood in tears, was intubated and crashed within 2 hours of arrival to hospital. Cerebrospinal fluid was collected and showed Gram-negative diplococci. Culture later tested positive for Neisseria meningitidis serogroup C.
Age: 18.0
Sex: M
Vaccine: MNQ
Symptoms: Lacrimal haemorrhage, Meningitis, Meningococcal bacteraemia, Neisseria test positive, Pyrexia
Clinical narrative: Non-specific symptoms began 1/12/2011, progressed to rash, fever, numbness in arms/legs 1/13. Taken to Emergency Department, experienced blood in tears, was intubated and crashed within 2 hours of arrival to hospital. Cerebrospinal fluid was collected and showed Gram-negative diplococci. Culture later tested positive for Neisseria meningitidis serogroup C.
Age: 18.0
Sex: M
Vaccine: MNQ
Symptoms: Rash
Clinical narrative: Non-specific symptoms began 1/12/2011, progressed to rash, fever, numbness in arms/legs 1/13. Taken to Emergency Department, experienced blood in tears, was intubated and crashed within 2 hours of arrival to hospital. Cerebrospinal fluid was collected and showed Gram-negative diplococci. Culture later tested positive for Neisseria meningitidis serogroup C.
Age: 63.0
Sex: M
Vaccine: PPV
Symptoms: Adenoma benign, Chills, Computerised tomogram normal, Condition aggravated, Eye pain
Clinical narrative: Information has been received from an approximately 63 year old male registered respiratory therapist with allergy to UROXATRAL and diabetes and a history of non-hodgkin's lymphoma and premature ventricular contractions who in 2002 was vaccinated with the first dose of PNEUMOVAX 23 (Lot # and expire date not reported), intramuscularly, without incident. On 11-JAN-2011, the patient was vaccinated with the second dose of PNEUMOVAX 23 (Lot # and expire date not reported), intramuscularly. Concomitant therapy included metoprolol, lisinopril (manufacturer unknown), FLOVENT, magnesium (unspecified), propafenone HCl, metformin, aspirin and generic simvastatin (manufacturer unknown). Patient stated that he had developed bouts of pneumonia in 2008 and in 2009 that were treated with antibiotics. Patient added that on 11-JAN-2011 within 1 hour of receiving the second dose of PNEUMOVAX 23, he experienced pain and swelling at the site. At 7 pm, patient developed "wretching" shaking, chills and a fever of 103.2 degrees F. On 12-JAN-2011 at 3 am, his chills stopped and his fever dropped to 100 degrees F. Patient indicated he was treated with aspirin and water. The patient sought medical attention by calling physician. At the time of the report, the outcome from pneumonia was unknown and patient was recovering from "wretching" shaking, fever, pain and swelling at the site. On follow up information from a patient who reported that his initial symptoms that were reported resolved quickly, however, patient added that more serious issues happened in the following week. He stated that on approximately 18-JAN-2011, he developed severe headaches with "pain in his left eye socket" which lasted for several days. Patient mentioned that he then contacted a neuro-ophthalmologist, on 18-JAN-2011. Patient stated that by this time, he had a "droopy left eye" and the physician suspected "bleeding of the brain on the left side". Physician sent him to the emergency room and the patient was admitted to the hospital on 18-JAN-2011 (also reported as 18-JAN-2010). Patient said that on an unspecified date a CT scan and an MRI were performed, and though no bleeding was found, an adenoma which had been dormant in his brain for "10 years" was observed to have increased in size. Patient stated that he had had an MRI in early December 2010 which had revealed that the adenoma was unchanged.  Patient said that before he was revaccinated with PNEUMOVAX 23, he had been asymptomatic. Patient was discharged from the hospital on 20-JAN-2011. Patient stated that the "drooping" and headaches had since resolved. Additional information has been requested.
Age: 63.0
Sex: M
Vaccine: PPV
Symptoms: Eyelid ptosis, Headache, Injection site pain, Injection site swelling, Nuclear magnetic resonance imaging brain abnormal
Clinical narrative: Information has been received from an approximately 63 year old male registered respiratory therapist with allergy to UROXATRAL and diabetes and a history of non-hodgkin's lymphoma and premature ventricular contractions who in 2002 was vaccinated with the first dose of PNEUMOVAX 23 (Lot # and expire date not reported), intramuscularly, without incident. On 11-JAN-2011, the patient was vaccinated with the second dose of PNEUMOVAX 23 (Lot # and expire date not reported), intramuscularly. Concomitant therapy included metoprolol, lisinopril (manufacturer unknown), FLOVENT, magnesium (unspecified), propafenone HCl, metformin, aspirin and generic simvastatin (manufacturer unknown). Patient stated that he had developed bouts of pneumonia in 2008 and in 2009 that were treated with antibiotics. Patient added that on 11-JAN-2011 within 1 hour of receiving the second dose of PNEUMOVAX 23, he experienced pain and swelling at the site. At 7 pm, patient developed "wretching" shaking, chills and a fever of 103.2 degrees F. On 12-JAN-2011 at 3 am, his chills stopped and his fever dropped to 100 degrees F. Patient indicated he was treated with aspirin and water. The patient sought medical attention by calling physician. At the time of the report, the outcome from pneumonia was unknown and patient was recovering from "wretching" shaking, fever, pain and swelling at the site. On follow up information from a patient who reported that his initial symptoms that were reported resolved quickly, however, patient added that more serious issues happened in the following week. He stated that on approximately 18-JAN-2011, he developed severe headaches with "pain in his left eye socket" which lasted for several days. Patient mentioned that he then contacted a neuro-ophthalmologist, on 18-JAN-2011. Patient stated that by this time, he had a "droopy left eye" and the physician suspected "bleeding of the brain on the left side". Physician sent him to the emergency room and the patient was admitted to the hospital on 18-JAN-2011 (also reported as 18-JAN-2010). Patient said that on an unspecified date a CT scan and an MRI were performed, and though no bleeding was found, an adenoma which had been dormant in his brain for "10 years" was observed to have increased in size. Patient stated that he had had an MRI in early December 2010 which had revealed that the adenoma was unchanged.  Patient said that before he was revaccinated with PNEUMOVAX 23, he had been asymptomatic. Patient was discharged from the hospital on 20-JAN-2011. Patient stated that the "drooping" and headaches had since resolved. Additional information has been requested.
Age: 63.0
Sex: M
Vaccine: PPV
Symptoms: Pneumonia, Pyrexia, Retching, Scan brain, Tremor
Clinical narrative: Information has been received from an approximately 63 year old male registered respiratory therapist with allergy to UROXATRAL and diabetes and a history of non-hodgkin's lymphoma and premature ventricular contractions who in 2002 was vaccinated with the first dose of PNEUMOVAX 23 (Lot # and expire date not reported), intramuscularly, without incident. On 11-JAN-2011, the patient was vaccinated with the second dose of PNEUMOVAX 23 (Lot # and expire date not reported), intramuscularly. Concomitant therapy included metoprolol, lisinopril (manufacturer unknown), FLOVENT, magnesium (unspecified), propafenone HCl, metformin, aspirin and generic simvastatin (manufacturer unknown). Patient stated that he had developed bouts of pneumonia in 2008 and in 2009 that were treated with antibiotics. Patient added that on 11-JAN-2011 within 1 hour of receiving the second dose of PNEUMOVAX 23, he experienced pain and swelling at the site. At 7 pm, patient developed "wretching" shaking, chills and a fever of 103.2 degrees F. On 12-JAN-2011 at 3 am, his chills stopped and his fever dropped to 100 degrees F. Patient indicated he was treated with aspirin and water. The patient sought medical attention by calling physician. At the time of the report, the outcome from pneumonia was unknown and patient was recovering from "wretching" shaking, fever, pain and swelling at the site. On follow up information from a patient who reported that his initial symptoms that were reported resolved quickly, however, patient added that more serious issues happened in the following week. He stated that on approximately 18-JAN-2011, he developed severe headaches with "pain in his left eye socket" which lasted for several days. Patient mentioned that he then contacted a neuro-ophthalmologist, on 18-JAN-2011. Patient stated that by this time, he had a "droopy left eye" and the physician suspected "bleeding of the brain on the left side". Physician sent him to the emergency room and the patient was admitted to the hospital on 18-JAN-2011 (also reported as 18-JAN-2010). Patient said that on an unspecified date a CT scan and an MRI were performed, and though no bleeding was found, an adenoma which had been dormant in his brain for "10 years" was observed to have increased in size. Patient stated that he had had an MRI in early December 2010 which had revealed that the adenoma was unchanged.  Patient said that before he was revaccinated with PNEUMOVAX 23, he had been asymptomatic. Patient was discharged from the hospital on 20-JAN-2011. Patient stated that the "drooping" and headaches had since resolved. Additional information has been requested.
Age: 65.0
Sex: F
Vaccine: PPV
Symptoms: Arthralgia, Blood test, Depressed level of consciousness, Flushing, Injection site pain
Clinical narrative: Information has been received from a registered nurse concerning a 65 year old female patient with reflux, thyroid disorder, penicillin allergy (caused her to have hives), DEMEROL allergy (caused her to have hypotension) and epinephrine allergy (caused her to have tachycardia) who on 20-JAN-2011 was vaccinated IM with a 0.5ml dose ("usual dose") of PNEUMOVAX 23 (lot # not reported). Concomitant therapy included "thyroid medication, reflux medication" and simvastatin. The patient stated that, on 20-JAN-2011 one hour after she was administered the PNEUMOVAX 23, she "had pain from her wrist up towards the injection site, tingling pain, flushing, fever and almost passed out". She was rushed to hospital and went to the emergency room. She was supplemented with oxygen and fluid. The patient had blood work performed, results were not reported. It was also reported that there was no treatment given for the adverse event. The patient was discharged on 20-JAN-2011 ("that same day"). On 24-JAN-2011, the patient had recovered. Pain from her wrist up towards the injection site, tingling pain, flushing, fever and almost passed out were considered to be an other important medical events and immediately life-threatening by the reporter because the patient required oxygen and fluids. Additional information has been requested. She was admitted to hospital.
Age: 65.0
Sex: F
Vaccine: PPV
Symptoms: Pain, Pain in extremity, Paraesthesia, Pyrexia
Clinical narrative: Information has been received from a registered nurse concerning a 65 year old female patient with reflux, thyroid disorder, penicillin allergy (caused her to have hives), DEMEROL allergy (caused her to have hypotension) and epinephrine allergy (caused her to have tachycardia) who on 20-JAN-2011 was vaccinated IM with a 0.5ml dose ("usual dose") of PNEUMOVAX 23 (lot # not reported). Concomitant therapy included "thyroid medication, reflux medication" and simvastatin. The patient stated that, on 20-JAN-2011 one hour after she was administered the PNEUMOVAX 23, she "had pain from her wrist up towards the injection site, tingling pain, flushing, fever and almost passed out". She was rushed to hospital and went to the emergency room. She was supplemented with oxygen and fluid. The patient had blood work performed, results were not reported. It was also reported that there was no treatment given for the adverse event. The patient was discharged on 20-JAN-2011 ("that same day"). On 24-JAN-2011, the patient had recovered. Pain from her wrist up towards the injection site, tingling pain, flushing, fever and almost passed out were considered to be an other important medical events and immediately life-threatening by the reporter because the patient required oxygen and fluids. Additional information has been requested. She was admitted to hospital.
Age: 20.0
Sex: F
Vaccine: HPV4
Symptoms: Drug exposure before pregnancy, Live birth, Pre-eclampsia, Premature labour, Ultrasound antenatal screen normal
Clinical narrative: Information has been received from a physician for GARDASIL, a Pregnancy Registry product, concerning an 20 year old female with 1 previous pregnancy including 1 spontaneous abortion (miscarriage) and no medical history or concurrent condition who was vaccinated with the third dose of GARDASIL (lot # 661846/1312X) on 27-JUL-2009 then became pregnant. Concomitant medication included PLAN B. Her estimated conception date was 10-AUG-2009 (LMP: 27-JUL-2009, EDD: 03-MAY-2010). Method of confirmation was unknown. Follow up information was received which reported that on 18-NOV-2009, 17-DEC-2009 and 05-JAN-2010, the patient underwent routine ultrasound and results revealed normal. On 28-FEB-2010, at 28 weeks from LMP, the patient delivered a liveborn infant with unspecified congenital anomaly (also reported normal). During labor/delivery, the patient experienced pre-eclampsia. It was also reported that the patient received PROCARDIA during this pregnancy for an unspecified indication. Upon internal review, infant born at 28 weeks from LMP was considered to be an other important medical event. Unspecified congenital anomaly was reported for the baby. The baby's experience has been captured in WAES 0909USA02628B1. Additional information has been requested.
Sex: F
Vaccine: HPV4
Symptoms: Congenital anomaly, Premature baby
Clinical narrative: Information has been received from a physician for GARDASIL, a Pregnancy Registry product, concerning a baby whose mother was an 20 year old female with 1 previous pregnancy including 1 spontaneous abortion (miscarriage) and no medical history or concurrent condition who was vaccinated with the third dose of GARDASIL (lot# 661846/1312X) on 27-JUL-2009 then became pregnant. Concomitant medication included PLAN B. The mother's estimated conception date was 10-AUG-2009 (LMP: 27-JUL-2009, EDD: 03-MAY-2010). Method of confirmation was unknown. On 18-NOV-2009, 17-DEC-2009 and 05-JAN-2010, the mother underwent routine ultrasound and results revealed normal. On 28-FEB-2010, at 28 weeks from LMP, the mother delivered a liveborn infant with unspecified congenital anomaly (also reported normal). Upon internal review, infant born at 28 weeks from LMP was considered to be an other important medical event. The mother's experience has been captured in WAES 0909USA02628. Additional information has been requested.