chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 8.0
Sex: U
Vaccine: VARCEL
Symptoms: Herpes zoster, Varicella virus test negative
Clinical narrative: Varivax #2 given on 2/15/07; #1 given 5-7-00 at previous PCP on 11-29-09 took to 2 ER's-Both dx shingles on (R) shoulder and (R) wrist. Culture done by CPHs - negative for varicella. This is a delayed FYI.
Age: 4.0
Sex: M
Vaccine: PNC13, VARCEL
Symptoms: Injection site erythema, Injection site warmth
Clinical narrative: Local erythema, warmth, 5x5cm and 3x3 area on (L) outer arm. Deltoid area.
Age: 4.0
Sex: F
Vaccine: DTAP
Symptoms: Injection site erythema, Injection site swelling
Clinical narrative: Redness and swollen on the site of where vaccine was given.
Age: 2.0
Sex: F
Vaccine: PNC13
Symptoms: Injection site erythema, Injection site swelling, Insomnia
Clinical narrative: Swollen right leg, red after immunizations yesterday (06/28). Started turning red today (06/29). Walking normally, no complain of pain but did not sleep well. Parents gave her TYLENOL.
Age: 2.0
Sex: M
Vaccine: PNC13
Symptoms: Urticaria
Clinical narrative: MD visit 7-7-10.  Per mom - patient woke up 7-6-10 covered in hives - all over body.  No insect bites/ stings noted.  No new exposures.  Benadryl helps symptoms briefly, but hives appear to be worsening.  Will continue with BENADRYL for now and add steroids if hives continue.
Age: 1.62
Sex: F
Vaccine: DTAP, HEPA
Symptoms: Injection site erythema, Injection site swelling
Clinical narrative: Swelling and redness of thigh started 1 day after receiving vaccine.  Erythema 12 cm X 14 cm with 4 cm diameter diff. between legs.
Age: 63.0
Sex: M
Vaccine: PPV
Symptoms: Injection site erythema, Injection site oedema, Injection site pain, Local reaction, Pyrexia
Clinical narrative: Patient received pneumococcal vaccine on 6/17/2010. Patient was seen the next day and reported that he was experiencing pain, edema, and redness at the injection site. Patient took oral BENADRYL and TYLENOL. Patient had a low grade fever of 100. Reaction was localized. There were no signs of anaphylaxis. Patient was prescribed oral BENADRYL. Treatment Drugs Used: 1 - Diphenhydramine Dose: 50 Units: MG Freq: QID Route: PO.
Age: 21.0
Sex: F
Vaccine: HPV4, HPV4
Symptoms: Blood test, Central venous catheterisation, Convulsion, Impaired driving ability, Impaired work ability
Clinical narrative: Information has been received from a consumer concerning her 21 year old daughter with no pertinent medical history and no known drug allergies who in March 2008 and May 2008 was vaccinated with a first and second doses of GARDASIL respectively (lot # not reported). Concomitant therapy included birth control medicine (unspecified). The consumer stated that the day after the second dose of GARDASIL in May 2008, the patient went to her internship/work and the mother was called because the patient fainted. She was taken to the unspecified emergency room and released. She again fainted at her internship/work and was taken to emergency room, where she had 8 witnessed seizures and was discharged with a diagnosis of a sinus infection. She then attended a barbeque, where the host called the mother to tell her that patient had a full blown seizure, not a fainting episode. She was then admitted to the hospital for 6 days with multiple tests done (metabolic test, blood test and many others, results not provided). The infectious disease physician suggested that the seizure activity may be related to GARDASIL injection. Patient was discharged to home, with intravenous access (peripherally inserted central catheter (PICC) line) for antibiotic therapy and placed on KEPPRA for anti-seizure therapy. She lost her internship, and had not been able to drive for the past two years. She had not had a full blown seizure but she can "feel them coming on".  At the time of the report, the patient had not recovered from the seizure. The outcome of the sinus infection was unknown. The consumer also noted that the patient has a twin sister (unknown whether the twin was vaccinated with GARDASIL). Additional information has been requested.
Age: 21.0
Sex: F
Vaccine: HPV4, HPV4
Symptoms: Laboratory test, Metabolic function test, Sinusitis, Syncope
Clinical narrative: Information has been received from a consumer concerning her 21 year old daughter with no pertinent medical history and no known drug allergies who in March 2008 and May 2008 was vaccinated with a first and second doses of GARDASIL respectively (lot # not reported). Concomitant therapy included birth control medicine (unspecified). The consumer stated that the day after the second dose of GARDASIL in May 2008, the patient went to her internship/work and the mother was called because the patient fainted. She was taken to the unspecified emergency room and released. She again fainted at her internship/work and was taken to emergency room, where she had 8 witnessed seizures and was discharged with a diagnosis of a sinus infection. She then attended a barbeque, where the host called the mother to tell her that patient had a full blown seizure, not a fainting episode. She was then admitted to the hospital for 6 days with multiple tests done (metabolic test, blood test and many others, results not provided). The infectious disease physician suggested that the seizure activity may be related to GARDASIL injection. Patient was discharged to home, with intravenous access (peripherally inserted central catheter (PICC) line) for antibiotic therapy and placed on KEPPRA for anti-seizure therapy. She lost her internship, and had not been able to drive for the past two years. She had not had a full blown seizure but she can "feel them coming on".  At the time of the report, the patient had not recovered from the seizure. The outcome of the sinus infection was unknown. The consumer also noted that the patient has a twin sister (unknown whether the twin was vaccinated with GARDASIL). Additional information has been requested.
Age: 21.0
Sex: F
Vaccine: HPV4, HPV4
Symptoms: Blood test, Convulsion, Impaired driving ability, Impaired work ability, Laboratory test
Clinical narrative: Information has been received from a consumer concerning her 21 year old daughter with no pertinent medical history and no known drug allergies who in March 2008 and May 2008 was vaccinated with a first and second doses of GARDASIL respectively (lot # not reported). Concomitant therapy included birth control medicine (unspecified). The consumer stated that the day after the second dose of GARDASIL in May 2008, the patient went to her internship/work and the mother was called because the patient fainted. She was taken to the unspecified emergency room and released. She again fainted at her internship/work and was taken to emergency room, where she had 8 witnessed seizures and was discharged with a diagnosis of a sinus infection. She then attended a barbeque, where the host called the mother to tell her that patient had a full blown seizure, not a fainting episode. She was then admitted to the hospital for 6 days with multiple tests done (metabolic test, blood test and many others, results not provided). The infectious disease physician suggested that the seizure activity may be related to GARDASIL injection. Patient was discharged to home, with intravenous access (peripherally inserted central catheter (PICC) line) for antibiotic therapy and placed on KEPPRA for anti-seizure therapy. She lost her internship, and had not been able to drive for the past two years. She had not had a full blown seizure but she can "feel them coming on".  At the time of the report, the patient had not recovered from the seizure. The outcome of the sinus infection was unknown. The consumer also noted that the patient has a twin sister (unknown whether the twin was vaccinated with GARDASIL). Additional information has been requested.
Age: 21.0
Sex: F
Vaccine: HPV4, HPV4
Symptoms: Metabolic function test, Sinusitis, Syncope
Clinical narrative: Information has been received from a consumer concerning her 21 year old daughter with no pertinent medical history and no known drug allergies who in March 2008 and May 2008 was vaccinated with a first and second doses of GARDASIL respectively (lot # not reported). Concomitant therapy included birth control medicine (unspecified). The consumer stated that the day after the second dose of GARDASIL in May 2008, the patient went to her internship/work and the mother was called because the patient fainted. She was taken to the unspecified emergency room and released. She again fainted at her internship/work and was taken to emergency room, where she had 8 witnessed seizures and was discharged with a diagnosis of a sinus infection. She then attended a barbeque, where the host called the mother to tell her that patient had a full blown seizure, not a fainting episode. She was then admitted to the hospital for 6 days with multiple tests done (metabolic test, blood test and many others, results not provided). The infectious disease physician suggested that the seizure activity may be related to GARDASIL injection. Patient was discharged to home, with intravenous access (peripherally inserted central catheter (PICC) line) for antibiotic therapy and placed on KEPPRA for anti-seizure therapy. She lost her internship, and had not been able to drive for the past two years. She had not had a full blown seizure but she can "feel them coming on".  At the time of the report, the patient had not recovered from the seizure. The outcome of the sinus infection was unknown. The consumer also noted that the patient has a twin sister (unknown whether the twin was vaccinated with GARDASIL). Additional information has been requested.
Age: 21.0
Sex: F
Vaccine: HPV4, HPV4
Symptoms: Blood test, Central venous catheterisation, Convulsion, Impaired driving ability, Impaired work ability
Clinical narrative: Information has been received from a consumer concerning her 21 year old daughter with no pertinent medical history and no known drug allergies who in March 2008 and May 2008 was vaccinated with a first and second doses of GARDASIL respectively (lot# not reported). Concomitant therapy included birth control medicine (unspecified). The consumer stated that the day after the second dose of GARDASIL in May 2008, the patient went to her internship/work and the mother was called because the patient fainted. She was taken to the unspecified emergency room and released. She again fainted at her internship/work and was taken to emergency room, where she had 8 witnessed seizures and was discharged with a diagnosis of sinus infection. She then attended a barbecue, where the host called the mother to tell her that patient had a full blown seizure, not a fainting episode. She was then admitted to the hospital for 6 days with multiple tests done (metabolic test, blood test and many others, results not provided). The infectious disease physician suggested that the seizure activity may be related to GARDASIL injection. Patient was discharged to home, with intravenous access (Peripherally inserted central catheter (PICC) line) for antibiotic therapy and placed on KEPPRA for anti-seizure therapy. She lost her internship, and had not been able to drive for the past two years. She had not had a full blown seizure but she can "feel them coming on". At the time of the report, the patient had not recovered from the seizure. The outcome of the sinus infection was unknown. The consumer also noted that the patient has a twin sister (unknown whether the twin was vaccinated with GARDASIL). Additional information has been requested.
Age: 21.0
Sex: F
Vaccine: HPV4, HPV4
Symptoms: Laboratory test, Metabolic function test, Sinusitis, Syncope
Clinical narrative: Information has been received from a consumer concerning her 21 year old daughter with no pertinent medical history and no known drug allergies who in March 2008 and May 2008 was vaccinated with a first and second doses of GARDASIL respectively (lot# not reported). Concomitant therapy included birth control medicine (unspecified). The consumer stated that the day after the second dose of GARDASIL in May 2008, the patient went to her internship/work and the mother was called because the patient fainted. She was taken to the unspecified emergency room and released. She again fainted at her internship/work and was taken to emergency room, where she had 8 witnessed seizures and was discharged with a diagnosis of sinus infection. She then attended a barbecue, where the host called the mother to tell her that patient had a full blown seizure, not a fainting episode. She was then admitted to the hospital for 6 days with multiple tests done (metabolic test, blood test and many others, results not provided). The infectious disease physician suggested that the seizure activity may be related to GARDASIL injection. Patient was discharged to home, with intravenous access (Peripherally inserted central catheter (PICC) line) for antibiotic therapy and placed on KEPPRA for anti-seizure therapy. She lost her internship, and had not been able to drive for the past two years. She had not had a full blown seizure but she can "feel them coming on". At the time of the report, the patient had not recovered from the seizure. The outcome of the sinus infection was unknown. The consumer also noted that the patient has a twin sister (unknown whether the twin was vaccinated with GARDASIL). Additional information has been requested.
Age: 21.0
Sex: F
Vaccine: HPV4, HPV4
Symptoms: Blood test, Convulsion, Impaired driving ability, Impaired work ability, Laboratory test
Clinical narrative: Information has been received from a consumer concerning her 21 year old daughter with no pertinent medical history and no known drug allergies who in March 2008 and May 2008 was vaccinated with a first and second doses of GARDASIL respectively (lot# not reported). Concomitant therapy included birth control medicine (unspecified). The consumer stated that the day after the second dose of GARDASIL in May 2008, the patient went to her internship/work and the mother was called because the patient fainted. She was taken to the unspecified emergency room and released. She again fainted at her internship/work and was taken to emergency room, where she had 8 witnessed seizures and was discharged with a diagnosis of sinus infection. She then attended a barbecue, where the host called the mother to tell her that patient had a full blown seizure, not a fainting episode. She was then admitted to the hospital for 6 days with multiple tests done (metabolic test, blood test and many others, results not provided). The infectious disease physician suggested that the seizure activity may be related to GARDASIL injection. Patient was discharged to home, with intravenous access (Peripherally inserted central catheter (PICC) line) for antibiotic therapy and placed on KEPPRA for anti-seizure therapy. She lost her internship, and had not been able to drive for the past two years. She had not had a full blown seizure but she can "feel them coming on". At the time of the report, the patient had not recovered from the seizure. The outcome of the sinus infection was unknown. The consumer also noted that the patient has a twin sister (unknown whether the twin was vaccinated with GARDASIL). Additional information has been requested.
Age: 21.0
Sex: F
Vaccine: HPV4, HPV4
Symptoms: Metabolic function test, Sinusitis, Syncope
Clinical narrative: Information has been received from a consumer concerning her 21 year old daughter with no pertinent medical history and no known drug allergies who in March 2008 and May 2008 was vaccinated with a first and second doses of GARDASIL respectively (lot# not reported). Concomitant therapy included birth control medicine (unspecified). The consumer stated that the day after the second dose of GARDASIL in May 2008, the patient went to her internship/work and the mother was called because the patient fainted. She was taken to the unspecified emergency room and released. She again fainted at her internship/work and was taken to emergency room, where she had 8 witnessed seizures and was discharged with a diagnosis of sinus infection. She then attended a barbecue, where the host called the mother to tell her that patient had a full blown seizure, not a fainting episode. She was then admitted to the hospital for 6 days with multiple tests done (metabolic test, blood test and many others, results not provided). The infectious disease physician suggested that the seizure activity may be related to GARDASIL injection. Patient was discharged to home, with intravenous access (Peripherally inserted central catheter (PICC) line) for antibiotic therapy and placed on KEPPRA for anti-seizure therapy. She lost her internship, and had not been able to drive for the past two years. She had not had a full blown seizure but she can "feel them coming on". At the time of the report, the patient had not recovered from the seizure. The outcome of the sinus infection was unknown. The consumer also noted that the patient has a twin sister (unknown whether the twin was vaccinated with GARDASIL). Additional information has been requested.
Age: 0.36
Sex: M
Vaccine: DTAPIPVHIB, PNC, RV5, DTAPIPVHIB, PNC, RV5
Symptoms: Autopsy, Death, Loss of consciousness, Respiratory arrest, Resuscitation
Clinical narrative: Initial case was received on 20 April 2010 from an attorney and additional information was provided via the VAERS Database (ID: 371039). On 12 August 2009 At 11:39 a.m. an infant had a four-month check-up and was found to be well. At 12:00 p.m. on 12 August 2009, the 4 month old male patient received a left leg injection of PENTACEL (lot number C3301AA), aright leg injection of PCV (lot number D39015, manufacturer Wyeth) and a oral dose of ROTAVIRUS (lot number 1695X, manufacturer Merck). The following morning on 13 August 2009 at 8:00 a.m. (20 hours later), he was found unconscious and not breathing by his parents. The patient was sleeping with his parents at the time. Cardiopulmonary resuscitation was initiated. Emergency medical services were called and found the infant in full code. He was transported to the hospital where he was "essentially dead on arrival." The patient's history from hospital records and cardiology consultation, with service dates 01 April 2009 to 13 August 2009, indicated the patient was "premature-36 weeks", and had history of jaundice, benign pulmonary flow murmur, tiny collateral vessel originating from descending thoracic aorta, seborrheic dermatitis, plagiocephaly, decreased upper body strength and circumcision. Records also noted fussy, gas, vomiting and diarrhea on unspecified dates. There were no concomitant medications. A postmortem skeletal survey showed no evidence of acute or healing fractures. An autopsy report (date performed not provided) listed the cause of death and manner of death as undetermined. Additional information abstracted: Pathological diagnosis-well baby by clinical history. Overlay cannot be excluded. Documents held by sender: Immunization record, VAERS report.
Age: 0.5
Sex: M
Vaccine: DTAPIPVHIB, PNC13, DTAPIPVHIB, PNC13, DTAPIPVHIB, PNC13, DTAPIPVHIB, PNC13
Symptoms: Death
Clinical narrative: Initial report was received 11 May 2010 from a health care professional. A six-month-old male patient had received PENTACEL, lot number C3450AA (lot number valid for DTap/IPV component, route and site not reported) and PREVNAR (manufacturer lot number, route and site not reported) on 07 May 2010 and a few hours later, the patient passed away. According to the reporter, the patient took a nap after leaving the clinic around 2:30pm and did not wake up. Emergency medical services were called and the patient was pronounced dead on site. No additional information was provided at the time of the report. Documents held by sender: None.
Age: 0.5
Sex: M
Vaccine: DTAPIPVHIB, PNC13, DTAPIPVHIB, PNC13, DTAPIPVHIB, PNC13, DTAPIPVHIB, PNC13
Symptoms: Autopsy, Death
Clinical narrative: Initial report was received 11 May 2010 from a health care professional. A six-month-old male patient had received PENTACEL, lot number C3450AA (lot number valid for DTap/IPV component, route and site not reported) and PREVNAR (manufacturer lot number, route and site not reported) on 07 May 2010 and a few hours later, the patient passed away. According to the reporter, the patient took a nap after leaving the clinic around 2:30pm and did not wake up. Emergency medical services were called and the patient was pronounced dead on site. No additional information was provided at the time of the report. Documents held by sender: None.
Age: 38.0
Sex: F
Vaccine: FLUX(H1N1)
Symptoms: Abortion spontaneous, Drug exposure during pregnancy, Haemorrhage
Clinical narrative: I was 6 weeks pregnant prior to getting the H1N1 vaccine.  I began bleeding the following morning and miscarried that day.
Age: 52.0
Sex: F
Vaccine: FLU(H1N1), HEP, TDAP
Symptoms: Arthralgia, Chills, Erythema, Mobility decreased, Oedema peripheral
Clinical narrative: Difficulty moving arm. Fever 100.1. Shivers for two days w/joint pain. Rt arm swollen and red.
Age: 52.0
Sex: F
Vaccine: FLU(H1N1), HEP, TDAP
Symptoms: Pyrexia
Clinical narrative: Difficulty moving arm. Fever 100.1. Shivers for two days w/joint pain. Rt arm swollen and red.
Age: 12.0
Sex: M
Vaccine: MNQ
Symptoms: Injection site erythema, Injection site oedema
Clinical narrative: 10 cm by 8 cm area of erythema and edema over injection site of left deltoid muscle.
Age: 17.0
Sex: M
Vaccine: MNQ, TDAP
Symptoms: Dizziness, Excoriation, Fall, Head injury, Loss of consciousness
Clinical narrative: Passed out, fell to floor bumping back of head, skinning left knee, only out for few seconds, felt better, able to walk to sit in chair, became dizzy, vomited large amount, ambulance came, bp 114/56 p 60.
Age: 17.0
Sex: M
Vaccine: MNQ, TDAP
Symptoms: Vomiting
Clinical narrative: Passed out, fell to floor bumping back of head, skinning left knee, only out for few seconds, felt better, able to walk to sit in chair, became dizzy, vomited large amount, ambulance came, bp 114/56 p 60.
Age: 4.0
Sex: M
Vaccine: DTAPIPV, MMR, VARCEL
Symptoms: Injection site pain, Injection site swelling, Injection site warmth
Clinical narrative: Swelling, warmth, tenderness on injection site.
Age: 57.0
Sex: M
Vaccine: MMRV, VARCEL
Symptoms: Inappropriate schedule of drug administration, Incorrect dose administered, Wrong drug administered
Clinical narrative: 57 y.o. received MMRV - not recommended to patients 13 years and older.  Pt was also given VARIVAX.
Age: 11.0
Sex: M
Vaccine: HEPA, TDAP
Symptoms: Dizziness, Myalgia, Nausea, Pyrexia, Vomiting
Clinical narrative: Mother reported, significant muscle aches, low grade fever, dizziness, nausea and vomiting.
Age: 80.0
Sex: F
Vaccine: PPV
Symptoms: Cellulitis, Erythema, Infection, Local reaction, Skin warm
Clinical narrative: Local infection reaction assoc with severe redness, heat, cellulitis to (L) wrist and hand requiring steroids and antibiotics.
Age: 13.0
Sex: F
Vaccine: HPV4, MNQ, TDAP, VARCEL
Symptoms: Asthenia, Malaise
Clinical narrative: CC: Nausea, H/A, dizzy. 6/29/10 22:19 presented to ER "not feeling well" ROS - c/o weakness E.D. Dx generalized weakness status post immunizations. Pt received req. immunizations with 9d appoint. ER consulted Peds hospitalist and ok'd to DC home - stable - 7/1 Phoned better per mom.
Age: 17.0
Sex: M
Vaccine: TYP
Symptoms: Full blood count normal, Headache, Laboratory test normal, Lumbar puncture normal, Metabolic function test
Clinical narrative: Pt developed high fever (103 degrees) after taking 3rd dose of oral Typhoid vaccine, followed few days later by H/A and neck stiffness. PCP sent him to ER for eval. w/u was normal.
Age: 17.0
Sex: M
Vaccine: TYP
Symptoms: Musculoskeletal stiffness, Pyrexia
Clinical narrative: Pt developed high fever (103 degrees) after taking 3rd dose of oral Typhoid vaccine, followed few days later by H/A and neck stiffness. PCP sent him to ER for eval. w/u was normal.
Age: 57.0
Sex: F
Vaccine: FLU(H1N1)
Symptoms: Abdominal pain, Body temperature increased, Chills, Diarrhoea, Fatigue
Clinical narrative: Notified by client that she received the H1N1 injection on 4/15/2010, and required hospitalization for 3 days from allergic reaction. Client started 4/16/2010 at 2 AM woke up perspiring, stated she felt very tired. Chills and temperature of 101, malaise, started before 12PM that day. Client went to doctors office and was admitted. During hospitalization she started having abdominal cramping and diarrhea. Private physician said she was probably having an allergic reaction to H1N1 vaccine. Discharged on 04/18/2010. States no problems at this time. Treatment - I.V. fluids. Medicine - abdominal cramping.
Age: 57.0
Sex: F
Vaccine: FLU(H1N1)
Symptoms: Hypersensitivity, Malaise, Night sweats, Vaccination complication
Clinical narrative: Notified by client that she received the H1N1 injection on 4/15/2010, and required hospitalization for 3 days from allergic reaction. Client started 4/16/2010 at 2 AM woke up perspiring, stated she felt very tired. Chills and temperature of 101, malaise, started before 12PM that day. Client went to doctors office and was admitted. During hospitalization she started having abdominal cramping and diarrhea. Private physician said she was probably having an allergic reaction to H1N1 vaccine. Discharged on 04/18/2010. States no problems at this time. Treatment - I.V. fluids. Medicine - abdominal cramping.
Age: 49.0
Sex: F
Vaccine: TDAP
Symptoms: Diarrhoea, Dyspnoea, Epistaxis, Fatigue, Haemoptysis
Clinical narrative: Pt presents stating Tdap and PPD with clinic on 4/23/2010. Several hours after injection with following complaints - fatigue, quadricept muscle twitching, nausea, pain, headache, sleepiness all weekend, fever > 102 x 2 days but not today/Friday and Saturday trouble breathing until she later passed a "white living tissue, quarter size with blooded strips from right nostril, coughing with small amount of bloody tissue as well" loose bowel - severe sore throat, stiff neck but this better today. Watery, red eyes, swollen face. Pt states multiple heart condition and high blood pressure, MVP, hx stroke. Had surgery two weeks ago for rectal polyps. Pt denies any difficulty breathing today - 4/27/2010. No redness or swelling at injection sites today noted, referred to health care center for evaluation. Pt stated "I will not go".
Age: 49.0
Sex: F
Vaccine: TDAP
Symptoms: Headache, Lacrimation increased, Muscle twitching, Musculoskeletal stiffness, Nausea
Clinical narrative: Pt presents stating Tdap and PPD with clinic on 4/23/2010. Several hours after injection with following complaints - fatigue, quadricept muscle twitching, nausea, pain, headache, sleepiness all weekend, fever > 102 x 2 days but not today/Friday and Saturday trouble breathing until she later passed a "white living tissue, quarter size with blooded strips from right nostril, coughing with small amount of bloody tissue as well" loose bowel - severe sore throat, stiff neck but this better today. Watery, red eyes, swollen face. Pt states multiple heart condition and high blood pressure, MVP, hx stroke. Had surgery two weeks ago for rectal polyps. Pt denies any difficulty breathing today - 4/27/2010. No redness or swelling at injection sites today noted, referred to health care center for evaluation. Pt stated "I will not go".
Age: 49.0
Sex: F
Vaccine: TDAP
Symptoms: Ocular hyperaemia, Oropharyngeal pain, Pain, Pyrexia, Somnolence
Clinical narrative: Pt presents stating Tdap and PPD with clinic on 4/23/2010. Several hours after injection with following complaints - fatigue, quadricept muscle twitching, nausea, pain, headache, sleepiness all weekend, fever > 102 x 2 days but not today/Friday and Saturday trouble breathing until she later passed a "white living tissue, quarter size with blooded strips from right nostril, coughing with small amount of bloody tissue as well" loose bowel - severe sore throat, stiff neck but this better today. Watery, red eyes, swollen face. Pt states multiple heart condition and high blood pressure, MVP, hx stroke. Had surgery two weeks ago for rectal polyps. Pt denies any difficulty breathing today - 4/27/2010. No redness or swelling at injection sites today noted, referred to health care center for evaluation. Pt stated "I will not go".
Age: 49.0
Sex: F
Vaccine: TDAP
Symptoms: Swelling face
Clinical narrative: Pt presents stating Tdap and PPD with clinic on 4/23/2010. Several hours after injection with following complaints - fatigue, quadricept muscle twitching, nausea, pain, headache, sleepiness all weekend, fever > 102 x 2 days but not today/Friday and Saturday trouble breathing until she later passed a "white living tissue, quarter size with blooded strips from right nostril, coughing with small amount of bloody tissue as well" loose bowel - severe sore throat, stiff neck but this better today. Watery, red eyes, swollen face. Pt states multiple heart condition and high blood pressure, MVP, hx stroke. Had surgery two weeks ago for rectal polyps. Pt denies any difficulty breathing today - 4/27/2010. No redness or swelling at injection sites today noted, referred to health care center for evaluation. Pt stated "I will not go".
Age: 25.0
Sex: F
Vaccine: TDAP
Symptoms: Arthralgia, Back pain, Nausea, Pyrexia
Clinical narrative: Presents to Health Dept. stating she received a Tdap + PPD on 4/23/2010 - States within 1-2 hrs. post receiving injection began having nausea, joint pain and lower back pain. Low grade fever Friday night only. Continues to have joint paint today. Referred to clinic for further evaluation. No complaints of pain, redness or swelling at injection site.
Age: 36.0
Sex: F
Vaccine: HEP
Symptoms: Pruritus, Rash generalised
Clinical narrative: Received 4/22/10 - first of series - not certain when itching began - but yesterday 4/27/10 became very uncomfortable with itching/rash over entire body. No difficulty breathing.
Age: 17.0
Sex: M
Vaccine: HEPA, TDAP
Symptoms: Blood pressure decreased, Cold sweat, Convulsion, Dizziness, Electrocardiogram
Clinical narrative: Patient came into the clinic to update his immunizations for college. All questions on immunization consent form were asked to mother and she answered no to all. After discussion the client and his mother decided to get the TDAP and HEP A vaccine. The patient was sitting on the exam table when the vaccines were administered. The patient, his mother and myself left the first exam room and walk approximately 10 feet to another exam room when the patient stated "I feel like I am going to pass out" he sat down in the chair immediately and slumped over to the right losing consciousness and I caught him before he could hit the floor. I leaned back up where he was resting his head on his mother's chest. I immediately called for RN to bring me a blood pressure cuff. During the time she was getting the cuff the patient seem to have a seizure as evident by a blank state, head thrown back, and decorticate posturing. I then advised PHT to call 911. I put the BP cuff on the patient and attempt to get a reading, however the machine would not pick one up. The patients pulse was present but slow and weak. I advised RN to get a wet cloth for the patient and she did and gave it to the patient's mother who applied it to his forehead and face. The patient was cold and clammy and mumbling. I advised PHT to get the Emergency medical supplies from the lab and attempted to repeat the blood pressure. The reading was 77/54 02 Sat was 90 on room air and pulse was 34. The patient appeared to then have another seizure and showed the same symptoms as above and then lose consciousness. At this pint I advised that we need to move the patient to the exam table. The patient was picked up from the chair by his mother, PHT, and me. After placing the patient on the table I advised PHT to elevate the patient's legs. The patient started to gain consciousness and his blood pressure at this point was 101/53, pulse 60, O2 Sat 99, EMS on scene. Continued to monitor patient. Blood pressure reading of 99/69 and 112/68. Patient remained in supine position while evaluating BP. Patient started getting some color back. EMS had patient sit on table for a couple of minutes. We then had the patient stand and repeated the blood pressure at which time patient experienced dizziness, turned very white, and started to appear to lose consciousness again. Blood pressure cuff would not even read due to orthostatic hypotension. We immediately placed patient back in supine position. EMS advised pt should probably be seem by ER or personal M.D. Patient's mother contacted M.D. office who advised her to have EMS take him to the ER. Patient was transported by EMS to Medical Center. Patient's mother at approximately 1:15. She advised that her son had been released from the ER. Blood work had been performed that demonstrated slight elevation of WBC's. EKG was normal. She also reported that the patient received 2 liters of Normal Saline. She reported that she is to follow up with her son's primary physician to see if he should get the second of HEP A.
Age: 12.0
Sex: F
Vaccine: HEPA, MNQ, VARCEL
Symptoms: Abdominal discomfort, Blood pressure normal, Heart rate normal
Clinical narrative: Client here today for immunizations. Client received VZV, HAP, MCV after vaccine admin. Approx. 10:30 am. client c/o upset stomach, cold compress admin to head. Client placed head between legs. BP 100/70, pulse 80. After 5 min client states she is okay while texting on phone. Incident reported to supervisor on duty.
Age: 28.0
Sex: F
Vaccine: TDAP
Symptoms: Body temperature increased, Diarrhoea, Erythema, Headache, Pain
Clinical narrative: Client noted soreness the morning of 5/26/10 and by lunch the area was real swollen and sore. Had temp. 100.4 5/26/10 p.m. Reported diarrhea on Thursday and c/o headache. Had been putting ice on site but had not taken any fever or pain relievers. Client to take BENADRYL 50 mg every 6 hours and Ibuprofen every 6 hours or TYLENOL every 4 hours and will continue to use ice compresses. Talked with client 5/29/10 - states swelling and redness have decreased.
Age: 28.0
Sex: F
Vaccine: TDAP
Symptoms: Pain in extremity, Swelling
Clinical narrative: Client noted soreness the morning of 5/26/10 and by lunch the area was real swollen and sore. Had temp. 100.4 5/26/10 p.m. Reported diarrhea on Thursday and c/o headache. Had been putting ice on site but had not taken any fever or pain relievers. Client to take BENADRYL 50 mg every 6 hours and Ibuprofen every 6 hours or TYLENOL every 4 hours and will continue to use ice compresses. Talked with client 5/29/10 - states swelling and redness have decreased.
Age: 29.0
Sex: F
Vaccine: HEP, HEPA
Symptoms: Pruritus, Rash, Urticaria
Clinical narrative: 6/1/10 - Client received HAVRIX and ENGERIX B thru clinic. 6/3/10 - Client states "whelps and rash started on abdomen, then later in day on back and both arms; itching. Client took BENADRYL did not help; client did not follow up with doctor." 6/14/10 Client came to health dept. wanted to know what to do. Nurse recommended to see doctor (none) urgent care or ? care.
Age: 16.0
Sex: M
Vaccine: MNQ, VARCEL
Symptoms: Fall, Unresponsive to stimuli
Clinical narrative: Client was given a Varicella and a Meningococcal vaccine on 5/20/2010 @ 1:20pm @ 1:30pm client fell to the floor and began unresponsive for 5-10 secs. EMS was called to the clinic.
Age: 16.0
Sex: F
Vaccine: HEPA, MNQ
Symptoms: Computerised tomogram normal, Fall, Head injury, Loss of consciousness, Syncope
Clinical narrative: Syncope with head injury from fall, followed by loc and tonic seizure activity 1-2 minutes resolved with O2 and stimulation/Trendelenberg.
Age: 16.0
Sex: F
Vaccine: HEPA, MNQ
Symptoms: Tonic convulsion
Clinical narrative: Syncope with head injury from fall, followed by loc and tonic seizure activity 1-2 minutes resolved with O2 and stimulation/Trendelenberg.
Age: 69.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site erythema, Injection site rash
Clinical narrative: Red rash at sight of injection - oval in shape.  No other information left on message to us.
Age: 61.0
Sex: F
Vaccine: TDAP
Symptoms: Injection site erythema, Injection site nodule
Clinical narrative: Patient states 4-5 days after receiving vaccine, she felt knots at injection site and upon inspection also noticed redness.  Patient states unsure of actual date/time because she had no other symptoms.
Age: 39.0
Sex: F
Vaccine: TDAP
Symptoms: Injection site pain
Clinical narrative: Severe pain at deltoid muscle where injection was given.  Using Tylenol and ibuprofen routinely without any relief.
Age: 79.0
Sex: F
Vaccine: PPV
Symptoms: Erythema, Oedema peripheral, Pain in extremity
Clinical narrative: On 7/7/10 Pt. reported increased redness, swelling & pain to right arm. Antibiotics prescribed on 7/7/10.
Age: 11.0
Sex: F
Vaccine: HEPA, MNQ, TDAP
Symptoms: Chills, Pain, Pyrexia
Clinical narrative: 101 degree fever, chills, body aches.
Age: 14.0
Sex: F
Vaccine: FLUN3
Symptoms: Angiotensin converting enzyme, Antineutrophil cytoplasmic antibody negative, Antinuclear antibody negative, Bacterial test negative, Blindness
Clinical narrative: Started with painless L blurry vision, fixed in size. 16 Oct - VF deficit.  18 Oct - MRI Brain/Orbits showed abnormal signal suspicious for L optic neuritis.  4 Nov - worsening sx, hospitalized, evaluated, treated with IV steroids followed by 10 day taper.  26 Nov, fever x2 days followed by decreased in L eye vision.  30 Nov - hospitalized, IV steroids x3 days then taper.  11 Dec - Neuro/Ophth eval showed no improvement of vision.  VA 20/400.  10 Jan 2010 - acute worsening of L eye vision.  11 Jan - IV steroids x3 days then 1 month taper.  24 Jan - MRI Brain/Orbits, C-Spine - L optic nerve signal enhancement, otherwise nml.  12 Feb - Neuro-Ophth second opinion.  Dx atypical optic neuritis with permanent vision loss.  12 May - Neuro-Ophth 3rd opinion - no change of recovery.  No other evaluation warranted.
Age: 14.0
Sex: F
Vaccine: FLUN3
Symptoms: Blood immunoglobulin G normal, Borrelia test negative, CSF cell count normal, CSF glucose normal, CSF immunoglobulin
Clinical narrative: Started with painless L blurry vision, fixed in size. 16 Oct - VF deficit.  18 Oct - MRI Brain/Orbits showed abnormal signal suspicious for L optic neuritis.  4 Nov - worsening sx, hospitalized, evaluated, treated with IV steroids followed by 10 day taper.  26 Nov, fever x2 days followed by decreased in L eye vision.  30 Nov - hospitalized, IV steroids x3 days then taper.  11 Dec - Neuro/Ophth eval showed no improvement of vision.  VA 20/400.  10 Jan 2010 - acute worsening of L eye vision.  11 Jan - IV steroids x3 days then 1 month taper.  24 Jan - MRI Brain/Orbits, C-Spine - L optic nerve signal enhancement, otherwise nml.  12 Feb - Neuro-Ophth second opinion.  Dx atypical optic neuritis with permanent vision loss.  12 May - Neuro-Ophth 3rd opinion - no change of recovery.  No other evaluation warranted.
Age: 14.0
Sex: F
Vaccine: FLUN3
Symptoms: CSF myelin basic protein normal, CSF protein normal, Chest X-ray normal, Computerised tomogram normal, HIV test negative
Clinical narrative: Started with painless L blurry vision, fixed in size. 16 Oct - VF deficit.  18 Oct - MRI Brain/Orbits showed abnormal signal suspicious for L optic neuritis.  4 Nov - worsening sx, hospitalized, evaluated, treated with IV steroids followed by 10 day taper.  26 Nov, fever x2 days followed by decreased in L eye vision.  30 Nov - hospitalized, IV steroids x3 days then taper.  11 Dec - Neuro/Ophth eval showed no improvement of vision.  VA 20/400.  10 Jan 2010 - acute worsening of L eye vision.  11 Jan - IV steroids x3 days then 1 month taper.  24 Jan - MRI Brain/Orbits, C-Spine - L optic nerve signal enhancement, otherwise nml.  12 Feb - Neuro-Ophth second opinion.  Dx atypical optic neuritis with permanent vision loss.  12 May - Neuro-Ophth 3rd opinion - no change of recovery.  No other evaluation warranted.
Age: 14.0
Sex: F
Vaccine: FLUN3
Symptoms: Human herpes virus 6 serology negative, Lumbar puncture normal, Nuclear magnetic resonance imaging brain abnormal, Nuclear magnetic resonance imaging spinal cord abnormal, Optic neuritis
Clinical narrative: Started with painless L blurry vision, fixed in size. 16 Oct - VF deficit.  18 Oct - MRI Brain/Orbits showed abnormal signal suspicious for L optic neuritis.  4 Nov - worsening sx, hospitalized, evaluated, treated with IV steroids followed by 10 day taper.  26 Nov, fever x2 days followed by decreased in L eye vision.  30 Nov - hospitalized, IV steroids x3 days then taper.  11 Dec - Neuro/Ophth eval showed no improvement of vision.  VA 20/400.  10 Jan 2010 - acute worsening of L eye vision.  11 Jan - IV steroids x3 days then 1 month taper.  24 Jan - MRI Brain/Orbits, C-Spine - L optic nerve signal enhancement, otherwise nml.  12 Feb - Neuro-Ophth second opinion.  Dx atypical optic neuritis with permanent vision loss.  12 May - Neuro-Ophth 3rd opinion - no change of recovery.  No other evaluation warranted.
Age: 14.0
Sex: F
Vaccine: FLUN3
Symptoms: Pupil fixed, Pyrexia, Urine analysis normal, Vision blurred, Visual acuity reduced
Clinical narrative: Started with painless L blurry vision, fixed in size. 16 Oct - VF deficit.  18 Oct - MRI Brain/Orbits showed abnormal signal suspicious for L optic neuritis.  4 Nov - worsening sx, hospitalized, evaluated, treated with IV steroids followed by 10 day taper.  26 Nov, fever x2 days followed by decreased in L eye vision.  30 Nov - hospitalized, IV steroids x3 days then taper.  11 Dec - Neuro/Ophth eval showed no improvement of vision.  VA 20/400.  10 Jan 2010 - acute worsening of L eye vision.  11 Jan - IV steroids x3 days then 1 month taper.  24 Jan - MRI Brain/Orbits, C-Spine - L optic nerve signal enhancement, otherwise nml.  12 Feb - Neuro-Ophth second opinion.  Dx atypical optic neuritis with permanent vision loss.  12 May - Neuro-Ophth 3rd opinion - no change of recovery.  No other evaluation warranted.
Age: 14.0
Sex: F
Vaccine: FLUN3
Symptoms: Visual field defect
Clinical narrative: Started with painless L blurry vision, fixed in size. 16 Oct - VF deficit.  18 Oct - MRI Brain/Orbits showed abnormal signal suspicious for L optic neuritis.  4 Nov - worsening sx, hospitalized, evaluated, treated with IV steroids followed by 10 day taper.  26 Nov, fever x2 days followed by decreased in L eye vision.  30 Nov - hospitalized, IV steroids x3 days then taper.  11 Dec - Neuro/Ophth eval showed no improvement of vision.  VA 20/400.  10 Jan 2010 - acute worsening of L eye vision.  11 Jan - IV steroids x3 days then 1 month taper.  24 Jan - MRI Brain/Orbits, C-Spine - L optic nerve signal enhancement, otherwise nml.  12 Feb - Neuro-Ophth second opinion.  Dx atypical optic neuritis with permanent vision loss.  12 May - Neuro-Ophth 3rd opinion - no change of recovery.  No other evaluation warranted.
Age: 74.0
Sex: F
Vaccine: VARZOS
Symptoms: Blister, Herpes zoster, Pain, Pruritus
Clinical narrative: Develops shingles on right side of face (under eye/nose)--itchy, painful, blisters. Tx:  Famvir 500mg QID x 10 days.
Sex: F
Vaccine: HPV4
Symptoms: Drug exposure during pregnancy, Foetal disorder
Clinical narrative: Information has been received from a consumer who on an unspecified date was inadvertently vaccinated with the third dose GARDASIL while pregnant. The mother reported that her male child throat was not connected to his stomach, had an esophageal fistula and had imperforated anus. At the time of the report, the outcome of the events was unknown. Upon internal review, throat was not connected to his stomach, esophageal fistula and imperforated anus were considered to be congenital anomalies. The mother's experience is captured in WAES 1006USA04079. Additional information has been requested.
Age: 11.0
Sex: F
Vaccine: HPV4, IPV, MNQ
Symptoms: Grand mal convulsion, Syncope
Clinical narrative: Information has been received from a physician concerning an 11 year old female who on 30-JUN-2010 was vaccinated with the first dose of GARDASIL (Lot# 663558/0819Y). Concomitant therapy included MENACTRA and unspecified poliovirus vaccine both on 30-JUN-2010. On 30-JUN-2010 the patient experienced an episode of full syncope with tonic-clonic seizure. The symptoms lasted 30 seconds. There was no lab or diagnostic test performed. The patient had sought medical attention in the physician's office and fully recovered there. Upon internal review, the syncope with tonic-clonic seizure was considered to be an other important medical event. Additional information has been requested.
Age: 90.0
Sex: F
Vaccine: VARZOS
Symptoms: Death, Diarrhoea, Malaise, Pain in extremity
Clinical narrative: Information has been received from a physician concerning a 90 year old female who on 24-JUN-2010 was vaccinated with a dose of ZOSTAVAX (Merck) (dose, route and lot number not reported). The physician reported that on Saturday (26-JUN-2010), the patient complained to a neighbor that she was not feeling well, had diarrhea and arm pain. The physician stated that the patient was found deceased at home on Monday 28-JUN-2010. The cause of death was unknown. The patient did not seek medical attention. Additional information has been requested.
Age: 66.0
Sex: F
Vaccine: VARZOS
Symptoms: Biopsy bone marrow, Idiopathic thrombocytopenic purpura, Immunoglobulin therapy, Platelet count decreased, Platelet transfusion
Clinical narrative: Information has been received from a licensed practical nurse concerning a 66 year old female patient with hypercholesterolaemia, "reflux disease", hypothyroidism and allergic to alendronate sodium (MSD) (WAES# 1007USA00354), LIPITOR, TRICOR, DYAZIDE, BONIVA, EVISTA, ACTONEL and simvastatin (MSD) (WAES# 1007USA00355), who on 01-APR-2010 was vaccinated with a dose of ZOSTAVAX (lot# 664628/1018Y). Concomitant therapy included PREVACID, ezetimibe (MSD) and levothyroxine Na. On 24-MAY-2010 the patient was diagnosed with idiopathic thrombocytopenic purpura. That same day platelet count was performed which was 6. The patient was referred to an hematologist. On 03-JUN-2010 a platelet count was performed which was 50,000. The patient also had a bone marrow biopsy, results not provided. It was reported that the patient was undergoing IV immunoglobulin therapy, as well as  platelet transfusions, and was recovering. The reporting nurse considered idiopathic thrombocytopenic purpura to be an other important medical event. The reporting nurse considered idiopathic thrombocytopenic purpura to be life-threatening due to low platelet count. A lot check has been requested. Additional information has been requested.
Age: 3.0
Sex: M
Vaccine: HIBV, PNC13
Symptoms: Injection site erythema, Vaccination site swelling
Clinical narrative: Swelling and redness to vaccine site, left leg that worsened as of 7/2/10 and has gradually improved.
Age: 1.01
Sex: F
Vaccine: HEPA, HIBV, MMR, PNC, VARCEL
Symptoms: Injection site erythema, Injection site induration, Injection site swelling
Clinical narrative: Immediately after reaction both inoculation areas to both thighs became indurated swollen and erythematous. Erythema 4-4.5 cm on both sides with central induration of 2.0 cm on both sides. After 15 minutes the induration resolved. After one hour the erythema completely resolved.
Age: 19.0
Sex: F
Vaccine: SMALL
Symptoms: Drug exposure during pregnancy, Urine human chorionic gonadotropin positive
Clinical narrative: Patient had negative urine HCG test done the day of the Smallpox administration. However, HCG result done on 4 Jul 10 was positive indicating that she was presumed to have been pregnant at the time of the vaccine.
Age: 80.0
Sex: M
Vaccine: VARZOS
Symptoms: Herpes zoster, Rash, Vaccine breakthrough infection
Clinical narrative: This customer called 7/7/10 at 9am.  He stated that he developed a rash 7/6/10 evening.  This occurred after his visit to his Dr. earlier in the day on 7/7/10.  I recommended he call his physician for further advice.  His physician called us around noon on 7/7/10 stating that he had must seen patient again and believes he has shingles.
Age: 3.0
Sex: M
Vaccine: PNC13
Symptoms: Injection site cellulitis, Injection site erythema, Injection site pain
Clinical narrative: Redness, soreness at injection site.
Age: 2.0
Sex: M
Vaccine: PNC13
Symptoms: Rash, Tenderness
Clinical narrative: Large local rash, 7 cm diameter with central clearing, mildly tender, no fever.
Age: 52.0
Sex: M
Vaccine: PPV
Symptoms: Erythema, Joint range of motion decreased, Oedema peripheral, Pain in extremity, Pyrexia
Clinical narrative: Pt complained of swelling of left arm with pain, redness, and fever, along with decreased range of motion.