chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 14.0
Sex: F
Vaccine: HPV4, HPV4
Symptoms: Antinuclear antibody negative, Blood uric acid normal, C-reactive protein normal, Full blood count normal, Gait disturbance
Clinical narrative: Information has been received from a physician concerning a 14 year old female with acne and no known drug allergies who on 29-SEP-2008 was vaccinated with the first dose of GARDASIL, 0.5ml IM on the left arm. Concomitant therapy included minocycline, FINACEA, fexofenadine hydrochloride (manufacturer unknown) and unspecified face wash. Subsequently the patient experienced pain on the arm of the injection since vaccination. In the middle of October 2008 the patient has swelling of the fingers, legs, toes, both arms, stiffness of the body and difficulty moving. The patient also had arthralgias of her arms, legs and back. The patient has been missing school because of the discomfort. The patient couldn't close her hands. Every part of her body was aching. Minocycline (unspecified manufacturer) was discontinued on 14-NOV-2008 and the patient has been able to move since 17-NOV-2008. The patient still has pain, swelling, and arthritis-like symptoms. The patient's work-up revealed normal RF, CBC, CRP, SED rate, ESR, but increased ALT (341) and AST (224). The patient sought medical attention. At the time of the report the patient was recovering. Pain on the arm of the injection, swelling of the fingers, legs, toes, both arms, stiffness of the body and difficulty moving. Every part of her body is aching and arthritis-like symptoms were considered to be disabling. Additional information has been requested.
Age: 14.0
Sex: F
Vaccine: HPV4, HPV4
Symptoms: Musculoskeletal pain, Oedema peripheral, Pain, Polyarthritis, Red blood cell sedimentation rate normal
Clinical narrative: Information has been received from a physician concerning a 14 year old female with acne and no known drug allergies who on 29-SEP-2008 was vaccinated with the first dose of GARDASIL, 0.5ml IM on the left arm. Concomitant therapy included minocycline, FINACEA, fexofenadine hydrochloride (manufacturer unknown) and unspecified face wash. Subsequently the patient experienced pain on the arm of the injection since vaccination. In the middle of October 2008 the patient has swelling of the fingers, legs, toes, both arms, stiffness of the body and difficulty moving. The patient also had arthralgias of her arms, legs and back. The patient has been missing school because of the discomfort. The patient couldn't close her hands. Every part of her body was aching. Minocycline (unspecified manufacturer) was discontinued on 14-NOV-2008 and the patient has been able to move since 17-NOV-2008. The patient still has pain, swelling, and arthritis-like symptoms. The patient's work-up revealed normal RF, CBC, CRP, SED rate, ESR, but increased ALT (341) and AST (224). The patient sought medical attention. At the time of the report the patient was recovering. Pain on the arm of the injection, swelling of the fingers, legs, toes, both arms, stiffness of the body and difficulty moving. Every part of her body is aching and arthritis-like symptoms were considered to be disabling. Additional information has been requested.
Age: 14.0
Sex: F
Vaccine: HPV4, HPV4
Symptoms: Rheumatoid factor negative
Clinical narrative: Information has been received from a physician concerning a 14 year old female with acne and no known drug allergies who on 29-SEP-2008 was vaccinated with the first dose of GARDASIL, 0.5ml IM on the left arm. Concomitant therapy included minocycline, FINACEA, fexofenadine hydrochloride (manufacturer unknown) and unspecified face wash. Subsequently the patient experienced pain on the arm of the injection since vaccination. In the middle of October 2008 the patient has swelling of the fingers, legs, toes, both arms, stiffness of the body and difficulty moving. The patient also had arthralgias of her arms, legs and back. The patient has been missing school because of the discomfort. The patient couldn't close her hands. Every part of her body was aching. Minocycline (unspecified manufacturer) was discontinued on 14-NOV-2008 and the patient has been able to move since 17-NOV-2008. The patient still has pain, swelling, and arthritis-like symptoms. The patient's work-up revealed normal RF, CBC, CRP, SED rate, ESR, but increased ALT (341) and AST (224). The patient sought medical attention. At the time of the report the patient was recovering. Pain on the arm of the injection, swelling of the fingers, legs, toes, both arms, stiffness of the body and difficulty moving. Every part of her body is aching and arthritis-like symptoms were considered to be disabling. Additional information has been requested.
Age: 14.0
Sex: F
Vaccine: HPV4, HPV4
Symptoms: Activities of daily living impaired, Alanine aminotransferase increased, Arthralgia, Arthritis, Aspartate aminotransferase increased
Clinical narrative: Information has been received from a physician concerning a 14 year old female with acne and no known drug allergies who on 29-SEP-2008 was vaccinated with the first dose of GARDASIL, 0.5ml IM on the left arm. Concomitant therapy included minocycline, FINACEA, fexofenadine hydrochloride (manufacturer unknown) and unspecified face wash. Subsequently the patient experienced pain on the arm of the injection since vaccination. In the middle of October 2008 the patient has swelling of the fingers, legs, toes, both arms, stiffness of the body and difficulty moving. The patient also had arthralgias of her arms, legs and back. The patient has been missing school because of the discomfort. The patient couldn't close her hands. Every part of her body was aching. Minocycline (unspecified manufacturer) was discontinued on 14-NOV-2008 and the patient has been able to move since 17-NOV-2008. The patient still has pain, swelling, and arthritis-like symptoms. The patient's work-up revealed normal RF, CBC, CRP, SED rate, ESR, but increased ALT (341) and AST (224). The patient sought medical attention. At the time of the report the patient was recovering. Pain on the arm of the injection, swelling of the fingers, legs, toes, both arms, stiffness of the body and difficulty moving. Every part of her body is aching and arthritis-like symptoms were considered to be disabling. Additional information has been requested.
Age: 14.0
Sex: F
Vaccine: HPV4, HPV4
Symptoms: Blood parathyroid hormone normal, C-reactive protein normal, Discomfort, Full blood count normal, Muscular weakness
Clinical narrative: Information has been received from a physician concerning a 14 year old female with acne and no known drug allergies who on 29-SEP-2008 was vaccinated with the first dose of GARDASIL, 0.5ml IM on the left arm. Concomitant therapy included minocycline, FINACEA, fexofenadine hydrochloride (manufacturer unknown) and unspecified face wash. Subsequently the patient experienced pain on the arm of the injection since vaccination. In the middle of October 2008 the patient has swelling of the fingers, legs, toes, both arms, stiffness of the body and difficulty moving. The patient also had arthralgias of her arms, legs and back. The patient has been missing school because of the discomfort. The patient couldn't close her hands. Every part of her body was aching. Minocycline (unspecified manufacturer) was discontinued on 14-NOV-2008 and the patient has been able to move since 17-NOV-2008. The patient still has pain, swelling, and arthritis-like symptoms. The patient's work-up revealed normal RF, CBC, CRP, SED rate, ESR, but increased ALT (341) and AST (224). The patient sought medical attention. At the time of the report the patient was recovering. Pain on the arm of the injection, swelling of the fingers, legs, toes, both arms, stiffness of the body and difficulty moving. Every part of her body is aching and arthritis-like symptoms were considered to be disabling. Additional information has been requested.
Age: 14.0
Sex: F
Vaccine: HPV4, HPV4
Symptoms: Musculoskeletal stiffness, Pain, Red blood cell sedimentation rate normal, Rheumatoid factor negative, Swelling
Clinical narrative: Information has been received from a physician concerning a 14 year old female with acne and no known drug allergies who on 29-SEP-2008 was vaccinated with the first dose of GARDASIL, 0.5ml IM on the left arm. Concomitant therapy included minocycline, FINACEA, fexofenadine hydrochloride (manufacturer unknown) and unspecified face wash. Subsequently the patient experienced pain on the arm of the injection since vaccination. In the middle of October 2008 the patient has swelling of the fingers, legs, toes, both arms, stiffness of the body and difficulty moving. The patient also had arthralgias of her arms, legs and back. The patient has been missing school because of the discomfort. The patient couldn't close her hands. Every part of her body was aching. Minocycline (unspecified manufacturer) was discontinued on 14-NOV-2008 and the patient has been able to move since 17-NOV-2008. The patient still has pain, swelling, and arthritis-like symptoms. The patient's work-up revealed normal RF, CBC, CRP, SED rate, ESR, but increased ALT (341) and AST (224). The patient sought medical attention. At the time of the report the patient was recovering. Pain on the arm of the injection, swelling of the fingers, legs, toes, both arms, stiffness of the body and difficulty moving. Every part of her body is aching and arthritis-like symptoms were considered to be disabling. Additional information has been requested.
Age: 22.0
Sex: F
Vaccine: FLUX
Symptoms: Chills, Injection site pain, Injection site urticaria, Pain in jaw, Pruritus
Clinical narrative: Initial large hives on the arm of the injection between shoulder and elbow, spreading down to forearm after two days. Extremely itchy and painful. Treated with anti-itch cream and oatmeal paste. Pain radiated up from injection site and into jaw, causing pain similar to toothache. Treated with OTC pain relievers. Fever and chills followed after two or three days of initial onset. Reaction subsided around/after November 18-19th, 2008.
Age: 22.0
Sex: F
Vaccine: FLUX
Symptoms: Pyrexia, Urticaria
Clinical narrative: Initial large hives on the arm of the injection between shoulder and elbow, spreading down to forearm after two days. Extremely itchy and painful. Treated with anti-itch cream and oatmeal paste. Pain radiated up from injection site and into jaw, causing pain similar to toothache. Treated with OTC pain relievers. Fever and chills followed after two or three days of initial onset. Reaction subsided around/after November 18-19th, 2008.
Age: 25.0
Sex: M
Vaccine: ANTH, SMALL, TYP
Symptoms: Back pain, Blood culture negative, Body temperature increased, CSF culture negative, CSF glucose normal
Clinical narrative: Was innoculated on 11/13/08 and was seen in sick call by military on 11/18/08. He was sent to hospital for neck stiffness/discomfort, temp 101, body aches legs and lower back, nausea, vomiting.  12/15/08-records received for DOS 11/18-11/21/08- DC DX: Viral meningitis, probably secondary to small pox vaccine. Intractable nausea, vomiting with headache with photophobia. Presented with 2 day C/O headache, nausea, photophobia and intractable vomiting. Temperature elevation, febrile.
Age: 25.0
Sex: M
Vaccine: ANTH, SMALL, TYP
Symptoms: CSF protein increased, CSF white blood cell count increased, Gram stain negative, Lumbar puncture, Musculoskeletal discomfort
Clinical narrative: Was innoculated on 11/13/08 and was seen in sick call by military on 11/18/08. He was sent to hospital for neck stiffness/discomfort, temp 101, body aches legs and lower back, nausea, vomiting.  12/15/08-records received for DOS 11/18-11/21/08- DC DX: Viral meningitis, probably secondary to small pox vaccine. Intractable nausea, vomiting with headache with photophobia. Presented with 2 day C/O headache, nausea, photophobia and intractable vomiting. Temperature elevation, febrile.
Age: 25.0
Sex: M
Vaccine: ANTH, SMALL, TYP
Symptoms: Musculoskeletal stiffness, Nausea, Pain, Pain in extremity, Red blood cells CSF positive
Clinical narrative: Was innoculated on 11/13/08 and was seen in sick call by military on 11/18/08. He was sent to hospital for neck stiffness/discomfort, temp 101, body aches legs and lower back, nausea, vomiting.  12/15/08-records received for DOS 11/18-11/21/08- DC DX: Viral meningitis, probably secondary to small pox vaccine. Intractable nausea, vomiting with headache with photophobia. Presented with 2 day C/O headache, nausea, photophobia and intractable vomiting. Temperature elevation, febrile.
Age: 25.0
Sex: M
Vaccine: ANTH, SMALL, TYP
Symptoms: Vaccination complication, Vomiting
Clinical narrative: Was innoculated on 11/13/08 and was seen in sick call by military on 11/18/08. He was sent to hospital for neck stiffness/discomfort, temp 101, body aches legs and lower back, nausea, vomiting.  12/15/08-records received for DOS 11/18-11/21/08- DC DX: Viral meningitis, probably secondary to small pox vaccine. Intractable nausea, vomiting with headache with photophobia. Presented with 2 day C/O headache, nausea, photophobia and intractable vomiting. Temperature elevation, febrile.
Sex: U
Vaccine: FLU3
Symptoms: Influenza
Clinical narrative: On 11 November 2008 we received a literature article. The authors conducted a case-cohort study estimating effectiveness of inactivated influenza vaccine in preventing inpatient/outpatient visits (emergency department [ED] and outpatient clinic). They compared vaccination status of laboratory-confirmed influenza cases with a cluster sample of children from a random sample of practices in 3 counties (subcohort) during the 2003-2004 and 2004-2005 seasons. The study was conducted in 3 counties. Children were defined as fully vaccinated if they received: (1) 2 vaccine doses in an influenza season, more than 24 days apart, with the second dose more than 14 days before ARI onset or (2) more than 1 vaccine dose in a prior influenza season and 1 dose in the current season more than 14 days before ARI onset. Children were partially vaccinated if they received (1) only 1 of 2 recommended doses during the current season more than 14 days before ARI onset or (2) 2 doses during the current season, with the second dose less than 24 days after the first or within 14 days of ARI onset. All other children were unvaccinated. During the 2003-2004 season a total of 8/210 children (who were fully vaccinated) and 21/210 children (who were partially vaccinated) experienced influenza infection. The authors identified 6 fully vaccinated children 6-23 months of age, and 13 partially vaccinated children 6-23 months of age, and 2 fully vaccinated children 24-59 months of age, and 8 partially vaccinated children 24-59 months of age. For the 2003-2004 season the company cannot exclude that the children received a Novartis influenza vaccine. During the 2004-2005 season the company had no product on the market. We received on 18 NOV 2008 and on 19 NOV 2008 from the author the information, that he has no further information. No change in assessment.
Age: 23.0
Sex: F
Vaccine: HPV4
Symptoms: Alopecia, Dermatologic examination, Immune system disorder, Psoriasis, Vaccination complication
Clinical narrative: Information has been received from a physician concerning a 23 year old female who on 17-OCT-2007, was vaccinated with the first 0.5 ml dose of GARDASIL (lot # 659435/1265U) in the left deltoid, on 19-DEC-2007, was vaccinated with the second 0.5 ml dose of GARDASIL (lot # 659439/1267U) in the left deltoid and on 15-APR-2008, was vaccinated with the third 0.5 ml dose of GARDASIL (lot # 659182/1757U) in the left deltoid. Concomitant therapy included LO OVRAL. In December 2007, the patient experienced severe psoriasis over face, neck, hands, feet and entire scalp causing hair loss. On an unspecified date, the patient was seen by a Dermatologist who performed a "work up". AT the time of reporting, the patient did not recover. Follow-up information on 19-NOV-2008 was received from a physician who reported that she was not able to add much more to her initial report. She stated that the patient's chart did not reflect when the adverse event occurred in December 2007. It was unknown if the onset was before or after the second GARDASIL dose on 19-DEC-2007. The doctor did report that there was no pertinent medical history and no concurrent conditions. She confirmed that the events were disabling and important medical events. The patient was currently taking HUMIRA and using a special shampoo. Dermatology reported that the events were an immune response to the vaccine.  Current outcome was not recovered. The physician would not be seeing this patient again until October 2009. The physician considered severe psoriasis and hair loss to be disabling and other important medical event. Additional information has been requested.  12/3/08 Dermatology consults received beginning 6/5/08 with DX: Sebopsoriasis. Pt presented with 6-8 month hx of facial, scalp and hand scaly patches.  F/u 7/7/08 with Dx: Seborrheic dermatitis.  Psoriasis.  Tinea versicolor. PE (+) for erythematous scaly patches on face, extremities and scalp. Started on Humira. Reported severe sores in mouth. Dx: aphthous ulcers. Herpes simplex virus. Humira d/c.
Age: 16.0
Sex: F
Vaccine: HPV4, MNQ
Symptoms: Abnormal labour, Caesarean section, Drug exposure during pregnancy
Clinical narrative: Initial and follow-up information has been received from a physician concerning a 16 year old female with no medical history, who on 10-OCT-2007 was vaccinated with a first dose of GARDASIL (Lot# 658282/1263U). Concomitant vaccinations included MENACTRA. Concomitant therapies started on 16-OCT-2007 included ceftriaxone sodium 125mg used to treat Gonorrhoea and azithromycin 1gm used to treat a Chlamydial infection. Subsequently, the patient was pregnant. The patient's last menstrual period was 26-SEP-2007 and her estimated delivery date was 02-JUL-2008. It was reported to be unknown if the patient had an ultrasound performed. The patient had no previous pregnancies and no full term deliveries. At the time of the report, the outcome of the patient was unknown. Follow-up information was received from the physician who reported that on 13-APR-2008 the patient had a emergency c-section for failure to progress and repetitive severed deceleration. The patient delivered a male baby, birth weight 6 lb 12 oz. length 481/2 inch, Apgar score 9/9. It was reported that the baby did not have any congenital abnormalities or other complications or abnormalities. Upon internal review, failure to progress and repetitive severed deceleration which resulted in an emergency cesarean section were considered to be other important medical events. Additional information is not expected.
Sex: U
Vaccine: PNC
Symptoms: Body temperature increased, C-reactive protein increased, Chest X-ray normal, Culture negative, Culture urine positive
Clinical narrative: This case was considered medically important for urine culture positive for Streptococcus pneumoniae. Information regarding PREVNAR was received from a healthcare professional regarding a 3-month-old patient who experienced fever, high white blood cell count, urine culture positive for Streptococcus pneumoniae and increased c-reactive protein. The patient received a dose in 2008. Relevant medical history was not provided. Concomitant medications were not reported. On an unspecified date in 2008, the patient experienced fever, high white blood cell count, increased c-reactive protein and was evaluated at the Emergency department. During the evaluation, a urine culture was found to be positive for Streptococcus pneumoniae. The patient's chest x-ray was found to be negative along with all other (unspecified) cultures. The reporter questioned whether PREVNAR (reported to have been given recently) could have caused the positive urine culture or the patient's current illness. In 2008 test results were: c-reactive protein (results: high); white blood cell count (results: high); culture (results: all other cultures negative); chest X-ray (results: negative); and body temperature (results: fever). No additional information was available at the time of this report.
Sex: U
Vaccine: PNC
Symptoms: Pyrexia, Streptococcal infection, White blood cell count increased
Clinical narrative: This case was considered medically important for urine culture positive for Streptococcus pneumoniae. Information regarding PREVNAR was received from a healthcare professional regarding a 3-month-old patient who experienced fever, high white blood cell count, urine culture positive for Streptococcus pneumoniae and increased c-reactive protein. The patient received a dose in 2008. Relevant medical history was not provided. Concomitant medications were not reported. On an unspecified date in 2008, the patient experienced fever, high white blood cell count, increased c-reactive protein and was evaluated at the Emergency department. During the evaluation, a urine culture was found to be positive for Streptococcus pneumoniae. The patient's chest x-ray was found to be negative along with all other (unspecified) cultures. The reporter questioned whether PREVNAR (reported to have been given recently) could have caused the positive urine culture or the patient's current illness. In 2008 test results were: c-reactive protein (results: high); white blood cell count (results: high); culture (results: all other cultures negative); chest X-ray (results: negative); and body temperature (results: fever). No additional information was available at the time of this report.
Age: 0.3
Sex: M
Vaccine: DTAP, HIBV, IPV, PNC, RV5
Symptoms: Intussusception, No reaction on previous exposure to drug
Clinical narrative: Information has been received from a physician concerning a 13 week old male who did not have any adverse effect from his first dose of ROTATEQ (lot # 660683/0309X) which was given on 19-SEP-2008. On 07-NOV-2008, the patient was vaccinated with ROTATEQ (lot # 661736/0690X) for his second dose. Concomitant therapy also given on 07-NOV-2008 included PREVNAR, ENGERIX-B, ACTHIB, poliovirus vaccine, DTaP and DT. On 12-NOV-2008, the patient experienced intussusceptions, medical attention was sought and was hospitalized. The patient stayed overnight in the hospital. At the time of reporting, the outcome was unknown. Additional information has been requested.  11/28/08 MR received for DOS 11/12-13/2008 with D/C DX: Intussusception.  Pt presented to ER with increasing irritability, decreased po intake and constant head shaking.  Vomited x 2 upon arrival at ER. PE (+) for palpable mass on RLQ/mid abdomen.  Following US confirmation of ileocolic IS, an air contrast enema successfully reduced IS. Tolerated feeds well post procedure. D/C next day.
Age: 16.0
Sex: F
Vaccine: HPV4, MNQ, PPV
Symptoms: Bone marrow oedema, Oedema peripheral, Pain in extremity
Clinical narrative: Information has been received from a physician concerning a 16 year old female with sickle cell disease who on 09-SEP-2008 was vaccinated in her right arm with PNEUMOVAX 23 (lot #657525/0554U). On 09-SEP-2008 the patient was also vaccinated in her left arm with MENACTRA and GARDASIL (lot # 660555/0279X). Shortly after the vaccinations, the patient developed pain and swelling on the right arm where she received the PNEUMOVAX 23. Unspecified medical attention was sought. The physician also reported that on 23-SEP-2008 the patient was hospitalized and at the time of reporting was still in the hospital. It was unknown if the cause of the hospitalization was the swelling on her arm. No further information was provided. Follow-up information was received from the physician. It was reported that the patient was vaccinated with the first dose of PNEUMOVAX 23 vaccine in her right deltoid at 10:53 am. The patient had no illness at time of vaccination. On 23-SEP-2008 the patient experienced bone marrow edema and pain crisis. Subsequently, the patient was hospitalized for 7 days. Laboratory tests included: X-ray and MRI of humerus. The patient recovered from bone marrow edema and pain crisis on an unspecified date. No further information is available.  12/29/2008 MR including hospital records received from PCP for DOS 9/23-10/1/2008 with DX: Sickle Cell Disease and R arm pain. Pt presented with hx of R arm pain following several vaccinations. Pain area includes R shoulder, upper arm, elbow, forearm, wrist and hand. Pt unable to move hand. MRI c/w sickle cell  crisis.
Age: 0.7
Sex: M
Vaccine: RV5
Symptoms: Abdominal distension, Abdominal pain, Barium enema abnormal, Enema administration, Lethargy
Clinical narrative: Information has been received from an investigator concerning an 8 month old male with reflux, eczema and reactive airways disease and a history of negative endoscopy and colonoscopy at 2 months of age and viral gastrointestinal illness one week prior who was vaccinated PO with his second dose of ROTATEQ. This report was part of a post-marketing surveillance program. The patient experienced less than 24 hours of bilious vomiting, abdominal distention, abdominal pain and lethargy 45 days after vaccination and was hospitalized for 3 days (possible intussusception). Reduction with an enema was unsuccessful but the patient's symptoms were reduced via surgery. The patient was discharged from the hospital on day 3. The outcome was unknown at the time of this report. At this time, relationship of bilious vomiting, abdominal distention, abdominal pain and lethargy to study therapy is unknown. Bilious vomiting, abdominal distention, abdominal pain and lethargy were considered to be an other important medical events (surgery) by the reporter. Additional information has been requested.
Age: 0.7
Sex: M
Vaccine: RV5
Symptoms: Surgery, Vomiting
Clinical narrative: Information has been received from an investigator concerning an 8 month old male with reflux, eczema and reactive airways disease and a history of negative endoscopy and colonoscopy at 2 months of age and viral gastrointestinal illness one week prior who was vaccinated PO with his second dose of ROTATEQ. This report was part of a post-marketing surveillance program. The patient experienced less than 24 hours of bilious vomiting, abdominal distention, abdominal pain and lethargy 45 days after vaccination and was hospitalized for 3 days (possible intussusception). Reduction with an enema was unsuccessful but the patient's symptoms were reduced via surgery. The patient was discharged from the hospital on day 3. The outcome was unknown at the time of this report. At this time, relationship of bilious vomiting, abdominal distention, abdominal pain and lethargy to study therapy is unknown. Bilious vomiting, abdominal distention, abdominal pain and lethargy were considered to be an other important medical events (surgery) by the reporter. Additional information has been requested.
Age: 78.0
Sex: M
Vaccine: VARZOS
Symptoms: Herpes zoster
Clinical narrative: Information has been received from a pharmacist concerning a 78 year old male with a history of unspecified prostatic operation who on 07-NOV-2008 was vaccinated with ZOSTAVAX (Merck). Concomitant therapy included statin (unspecified) and unspecified prostate medication. On 13-NOV-2008 the patient developed shingles. The patient was put on BANCTROBAN and was feeling much better "today" (19-NOV-2008). At the time of this report, the patient was not recovered. The patient sought medical attention by office visit. Shingles was considered to be immediately life-threatening and disabling. Additional information has been requested.
Age: 20.0
Sex: F
Vaccine: VARZOS
Symptoms: Herpes zoster, Secondary transmission
Clinical narrative: Information has been received from a registered nurse (R.N.) concerning her 20 year old grand daughter who got a letter from her in late August or early September (WAES# 0809USA03784). The R.N. developed shingles on 01-SEP-2008. On 06-SEP-2008 her grand daughter was diagnosed with shingles on the left side of her face. At the time of this report, the outcome was unknown. Follow up information was received from the R.N. who reported that in the morning of 01-SEP-2008 her granddaughter with no pre-existing allergies, birth defects and medical conditions who developed blisters which fluid filled, painful line broke out on left upper cheek tracking to and into left eye. On 08-SEP-2008 the patient went to emergency room and was diagnosed with shingles. At the time of this report, the outcome was unknown. Shingles was considered to be disabling and an other important medical event. Additional information is not expected. This is one of several reports from the same source.
Sex: F
Vaccine: VARZOS
Symptoms: Blister, Heat rash, Herpes zoster, Pain, Rash erythematous
Clinical narrative: Information has been received from a registered nurse (R.N.) concerning herself who in late June 2008 vaccinated her husband with a dose of ZOSTAVAX (Merck). About a week later, her husband developed a mild, red, "heat" rash (WAES# 0809USA02419). On 01-SEP-2008 she started to develop shingles lesions on the left side of her face. On 05-SEP-2008 she was diagnosed with shingles by her family physician. She was treated with ZOVIRAX ointment and TYLENOL WITH CODEINE #3. She was already on therapy with hydrochlorothiazide, atenolol, aspirin and CRESTOR. She developed about 12 vesicular lesions. At the time of this report, the patient was recovering. Follow up information was received from the R.N. who reported that at 9AM on 12-JUL-2008 she vaccinated her husband with a first dose of ZOSTAVAX (Merck) (lot# 659409/0409X) subcutaneously in his right arm. She had no pre-existing allergies, birth defects and medical conditions. In the morning of 01-SEP-2008, she experienced blisters with fluid filled, lesion on left side of lung, painful line broke out on left lower jaw tracking to left lower lip and pain left ear. On 06-SEP-2008 she visited a physician and was diagnosed with shingles. At the time of this report, she recovered. Shingles was considered to be disabling and an other important medical event. Additional information is not expected. This is one of several reports from the same source.
Sex: F
Vaccine: VARZOS
Symptoms: Rash vesicular, Secondary transmission
Clinical narrative: Information has been received from a registered nurse (R.N.) concerning herself who in late June 2008 vaccinated her husband with a dose of ZOSTAVAX (Merck). About a week later, her husband developed a mild, red, "heat" rash (WAES# 0809USA02419). On 01-SEP-2008 she started to develop shingles lesions on the left side of her face. On 05-SEP-2008 she was diagnosed with shingles by her family physician. She was treated with ZOVIRAX ointment and TYLENOL WITH CODEINE #3. She was already on therapy with hydrochlorothiazide, atenolol, aspirin and CRESTOR. She developed about 12 vesicular lesions. At the time of this report, the patient was recovering. Follow up information was received from the R.N. who reported that at 9AM on 12-JUL-2008 she vaccinated her husband with a first dose of ZOSTAVAX (Merck) (lot# 659409/0409X) subcutaneously in his right arm. She had no pre-existing allergies, birth defects and medical conditions. In the morning of 01-SEP-2008, she experienced blisters with fluid filled, lesion on left side of lung, painful line broke out on left lower jaw tracking to left lower lip and pain left ear. On 06-SEP-2008 she visited a physician and was diagnosed with shingles. At the time of this report, she recovered. Shingles was considered to be disabling and an other important medical event. Additional information is not expected. This is one of several reports from the same source.
Age: 23.0
Sex: F
Vaccine: HPV4
Symptoms: Coma, Paralysis
Clinical narrative: Information has been received from a company representative reported that she read about a teen in a High School new article.  The article talks about a 23 year old female who went into a coma after receiving GARDASIL (Lot # was not available) and was paralyzed.  Upon internal review, paralysis and coma determined to be other important medical events.  This is one of several reports from the same source.  Attempts are being made to verify the existence of an identifiable patient and reporter.
Age: 14.0
Sex: F
Vaccine: HPV4
Symptoms: Convulsion
Clinical narrative: Information has been received from a company representative she reported that she read about a teen in High School article. The article talks about a 14 year old female who experienced seizures after receiving the first dose of GARDASIL (Lot # was not available). Upon internal review, seizure was determined to be other important medical event. This is one of several reports from the same source. Additional information has been requested. Attempts are being made to verify the existence of an identifiable patient and reporter.
Age: 65.0
Sex: F
Vaccine: FLU3
Symptoms: Cough, Cough, Dizziness, Enlarged uvula, Fatigue
Clinical narrative: Received vaccine Friday November 7, 2008 at ~ 8:35 am. At 12:45 pm Friday Nov. 7, 2008 experienced very sudden onset of: 1. congestion in area near epiglottis/upper trachea requiring continuous attempts to clear throat of mucous; mild-to moderate non-productive cough with mild wheeze-like sounds on expirations.  2. throat in above area had burning/raw and some itching sensations.  3. about 10 minutes later pharynx presented with same burning/raw and some itching sensations; uvula was reddened with mild swelling (approximate 1.25 - 1.5 X normal size).  4. about 15 minutes after onset of symptoms 1-3, took 2 mg. Chlorpheniramine.  5. at same time as #3, experienced start of mild headache but also moderate lightheadedness; there was no dizziness or vertigo.  6. about 1 hr later sensation in throat and pharynx progressed to nares. 7. was extremely cold but did not experience shaking chills; lasted for ~ 4hrs. after onset of pulmonary symptoms.  8. frequent hourly urination which started approximately 1/2 hour after initial symptoms (see #1 above) began; dipstick was negative for UTI (negative leukocyte esterase and nitrite).  9. symptoms in epiglottis area/upper trachea started to abate in about 20-30 minutes post administration of antihistamine noted in #4.  10. all symptoms were basically resolved by 9 hours post initiation of adverse reactions; did feel tired but next morning basically OK except some residual clearing of throat (not uncommon with concurrent ragweed/grass allergy symptoms at this time.
Age: 65.0
Sex: F
Vaccine: FLU3
Symptoms: Feeling cold, Headache, Nasal discomfort, Pharyngeal erythema, Pollakiuria
Clinical narrative: Received vaccine Friday November 7, 2008 at ~ 8:35 am. At 12:45 pm Friday Nov. 7, 2008 experienced very sudden onset of: 1. congestion in area near epiglottis/upper trachea requiring continuous attempts to clear throat of mucous; mild-to moderate non-productive cough with mild wheeze-like sounds on expirations.  2. throat in above area had burning/raw and some itching sensations.  3. about 10 minutes later pharynx presented with same burning/raw and some itching sensations; uvula was reddened with mild swelling (approximate 1.25 - 1.5 X normal size).  4. about 15 minutes after onset of symptoms 1-3, took 2 mg. Chlorpheniramine.  5. at same time as #3, experienced start of mild headache but also moderate lightheadedness; there was no dizziness or vertigo.  6. about 1 hr later sensation in throat and pharynx progressed to nares. 7. was extremely cold but did not experience shaking chills; lasted for ~ 4hrs. after onset of pulmonary symptoms.  8. frequent hourly urination which started approximately 1/2 hour after initial symptoms (see #1 above) began; dipstick was negative for UTI (negative leukocyte esterase and nitrite).  9. symptoms in epiglottis area/upper trachea started to abate in about 20-30 minutes post administration of antihistamine noted in #4.  10. all symptoms were basically resolved by 9 hours post initiation of adverse reactions; did feel tired but next morning basically OK except some residual clearing of throat (not uncommon with concurrent ragweed/grass allergy symptoms at this time.
Age: 65.0
Sex: F
Vaccine: FLU3
Symptoms: Rhinalgia, Throat irritation, Throat irritation, Upper respiratory tract congestion, Urine analysis normal
Clinical narrative: Received vaccine Friday November 7, 2008 at ~ 8:35 am. At 12:45 pm Friday Nov. 7, 2008 experienced very sudden onset of: 1. congestion in area near epiglottis/upper trachea requiring continuous attempts to clear throat of mucous; mild-to moderate non-productive cough with mild wheeze-like sounds on expirations.  2. throat in above area had burning/raw and some itching sensations.  3. about 10 minutes later pharynx presented with same burning/raw and some itching sensations; uvula was reddened with mild swelling (approximate 1.25 - 1.5 X normal size).  4. about 15 minutes after onset of symptoms 1-3, took 2 mg. Chlorpheniramine.  5. at same time as #3, experienced start of mild headache but also moderate lightheadedness; there was no dizziness or vertigo.  6. about 1 hr later sensation in throat and pharynx progressed to nares. 7. was extremely cold but did not experience shaking chills; lasted for ~ 4hrs. after onset of pulmonary symptoms.  8. frequent hourly urination which started approximately 1/2 hour after initial symptoms (see #1 above) began; dipstick was negative for UTI (negative leukocyte esterase and nitrite).  9. symptoms in epiglottis area/upper trachea started to abate in about 20-30 minutes post administration of antihistamine noted in #4.  10. all symptoms were basically resolved by 9 hours post initiation of adverse reactions; did feel tired but next morning basically OK except some residual clearing of throat (not uncommon with concurrent ragweed/grass allergy symptoms at this time.
Age: 65.0
Sex: F
Vaccine: FLU3
Symptoms: Wheezing, Wheezing
Clinical narrative: Received vaccine Friday November 7, 2008 at ~ 8:35 am. At 12:45 pm Friday Nov. 7, 2008 experienced very sudden onset of: 1. congestion in area near epiglottis/upper trachea requiring continuous attempts to clear throat of mucous; mild-to moderate non-productive cough with mild wheeze-like sounds on expirations.  2. throat in above area had burning/raw and some itching sensations.  3. about 10 minutes later pharynx presented with same burning/raw and some itching sensations; uvula was reddened with mild swelling (approximate 1.25 - 1.5 X normal size).  4. about 15 minutes after onset of symptoms 1-3, took 2 mg. Chlorpheniramine.  5. at same time as #3, experienced start of mild headache but also moderate lightheadedness; there was no dizziness or vertigo.  6. about 1 hr later sensation in throat and pharynx progressed to nares. 7. was extremely cold but did not experience shaking chills; lasted for ~ 4hrs. after onset of pulmonary symptoms.  8. frequent hourly urination which started approximately 1/2 hour after initial symptoms (see #1 above) began; dipstick was negative for UTI (negative leukocyte esterase and nitrite).  9. symptoms in epiglottis area/upper trachea started to abate in about 20-30 minutes post administration of antihistamine noted in #4.  10. all symptoms were basically resolved by 9 hours post initiation of adverse reactions; did feel tired but next morning basically OK except some residual clearing of throat (not uncommon with concurrent ragweed/grass allergy symptoms at this time.
Age: 35.0
Sex: F
Vaccine: FLU3
Symptoms: Blood pressure normal, Dizziness, Ear, nose and throat examination normal, Heart rate normal, Neurological examination normal
Clinical narrative: Patient presented to clinic about 20 minutes after receiving FLUVIRIN c/o throat swelling (mild) described as "cotton throat" no shortness of breath, no facial, tongue, or lip swelling, c/o mild dizziness. No prior reaction to FLUVIRIN. VSS IM Benadryl 50mg. given with significant improvement of symptoms, improved throat. Within 30-40 minutes after receiving Benadryl 50mg x 1 dose, patient reported significant improvement of throat swelling about 75% improvement. Dizziness improved after ate a nutrition/ energy bar and water. Vital signs stable. Ortho-static BPS/HR stable. HEENT/Respirtory/Cardiac and Neuo exam all stable/ normal. Alert and oriented x3 patient discharged in stable condition and advised to call 911 if symptoms recurred or worsened. Patient expressed understanding of plan. Advised to discuss future eligibility for FLUVIRIN vaccine with her primary care provider and inside under allergy skin testing.
Age: 35.0
Sex: F
Vaccine: FLU3
Symptoms: No reaction on previous exposure to drug, Oxygen saturation normal, Pharyngeal oedema
Clinical narrative: Patient presented to clinic about 20 minutes after receiving FLUVIRIN c/o throat swelling (mild) described as "cotton throat" no shortness of breath, no facial, tongue, or lip swelling, c/o mild dizziness. No prior reaction to FLUVIRIN. VSS IM Benadryl 50mg. given with significant improvement of symptoms, improved throat. Within 30-40 minutes after receiving Benadryl 50mg x 1 dose, patient reported significant improvement of throat swelling about 75% improvement. Dizziness improved after ate a nutrition/ energy bar and water. Vital signs stable. Ortho-static BPS/HR stable. HEENT/Respirtory/Cardiac and Neuo exam all stable/ normal. Alert and oriented x3 patient discharged in stable condition and advised to call 911 if symptoms recurred or worsened. Patient expressed understanding of plan. Advised to discuss future eligibility for FLUVIRIN vaccine with her primary care provider and inside under allergy skin testing.
Age: 0.3
Sex: M
Vaccine: DTAP, HIBV, PNC, RV5
Symptoms: Dyskinesia, Eye rolling
Clinical narrative: Child started to have symptoms of eye rolling and involuntary side to side head movement. The onset of these  symptoms started to occur within 12-hours of vaccine administration.
Age: 15.0
Sex: F
Vaccine: HPV4, HPV4
Symptoms: Heart rate increased, Orthostatic hypotension, Presyncope
Clinical narrative: Orthostatic hypotension with presyncope, close monitoring, and hydration.
Age: 15.0
Sex: F
Vaccine: HPV4, HPV4
Symptoms: Dizziness, Gait disturbance, Nausea, Orthostatic hypotension, Sensation of heaviness
Clinical narrative: Orthostatic hypotension with presyncope, close monitoring, and hydration.
Age: 15.0
Sex: F
Vaccine: HPV4, HPV4
Symptoms: Urine analysis, Vision blurred
Clinical narrative: Orthostatic hypotension with presyncope, close monitoring, and hydration.
Age: 49.0
Sex: M
Vaccine: FLU3
Symptoms: Aldolase, Anaphylactic reaction, Antimitochondrial antibody, Antinuclear antibody, Asthenia
Clinical narrative: 09/10/2008 Pain in injection area, increasing left shoulder pain 09/17/2008, left shoulder/chest pain. 9/26/2008 Anaphactic reaction all over body pain, weakness. 10/08 all over body pain/weakness, chest pain. 11/08 all over body pain/weakness and still has chest pain.
Age: 49.0
Sex: M
Vaccine: FLU3
Symptoms: Blood creatine phosphokinase, C-reactive protein, Cardiac stress test, Chest pain, Computerised tomogram
Clinical narrative: 09/10/2008 Pain in injection area, increasing left shoulder pain 09/17/2008, left shoulder/chest pain. 9/26/2008 Anaphactic reaction all over body pain, weakness. 10/08 all over body pain/weakness, chest pain. 11/08 all over body pain/weakness and still has chest pain.
Age: 49.0
Sex: M
Vaccine: FLU3
Symptoms: Electrocardiogram, Injection site pain, Metabolic function test, Musculoskeletal pain, Pain
Clinical narrative: 09/10/2008 Pain in injection area, increasing left shoulder pain 09/17/2008, left shoulder/chest pain. 9/26/2008 Anaphactic reaction all over body pain, weakness. 10/08 all over body pain/weakness, chest pain. 11/08 all over body pain/weakness and still has chest pain.
Age: 49.0
Sex: M
Vaccine: FLU3
Symptoms: Red blood cell sedimentation rate, Smooth muscle antibody
Clinical narrative: 09/10/2008 Pain in injection area, increasing left shoulder pain 09/17/2008, left shoulder/chest pain. 9/26/2008 Anaphactic reaction all over body pain, weakness. 10/08 all over body pain/weakness, chest pain. 11/08 all over body pain/weakness and still has chest pain.
Age: 1.0
Sex: F
Vaccine: UNK
Symptoms: Rash, Rhinorrhoea, Skin lesion
Clinical narrative: Rash started 2 days after flu shot 10/10/08. Runny nose and a few lesions on trunk exterior,hand.
Age: 4.0
Sex: F
Vaccine: DTAP, HEPA, IPV, MMR, VARCEL
Symptoms: Injection site erythema, Injection site swelling, Injection site vesicles
Clinical narrative: Children received DTaP and HEP A (L) thigh, IPV, Varicella (R) thigh and MMR (L) deltoid. Came back 2 days later with redness, swelling and blisters surrounding injection site. Received Abx.
Age: 0.9
Sex: F
Vaccine: HEP, IPV, PPV
Symptoms: Blister, Pyrexia, Rash erythematous, Rash macular
Clinical narrative: Patient had fever 100 degrees( subjectively at home) ( current otitis media). Presented with erythematus macules , vesicles over lower extremities, near diaper area which were absent at the time of vaccination, rest of skin was spared. These lesions resolved over 5 days with topical CALADRYL lotion.
Age: 34.0
Sex: M
Vaccine: FLU3, TDAP
Symptoms: Erythema, Fatigue, Hypoaesthesia, Injection site pain, Musculoskeletal stiffness
Clinical narrative: Received flu vaccine and Tdap on same day - reports soreness at Tdap injection site for a couple days but has had shoulder stiffness since then. Denies redness, edema, numbness or tingling in arm just stiff and tired at end of day especially when raising arm above head.
Age: 34.0
Sex: M
Vaccine: FLU3, TDAP
Symptoms: Oedema peripheral, Paraesthesia
Clinical narrative: Received flu vaccine and Tdap on same day - reports soreness at Tdap injection site for a couple days but has had shoulder stiffness since then. Denies redness, edema, numbness or tingling in arm just stiff and tired at end of day especially when raising arm above head.
Age: 24.0
Sex: F
Vaccine: ANTH
Symptoms: Dizziness, Facial pain, Headache, Injection site mass, Nausea
Clinical narrative: Golf ball sized lump at injection site, body aches, fever, headache behind right eye, throbbing severe every day since vaccine 24 NOVEMBER 08. Nausea during headache, dizziness, sharp pain for 2-3 hours on right side of face. Limited vision and light sensitivity.
Age: 24.0
Sex: F
Vaccine: ANTH
Symptoms: Pain, Photophobia, Pyrexia, Visual acuity reduced
Clinical narrative: Golf ball sized lump at injection site, body aches, fever, headache behind right eye, throbbing severe every day since vaccine 24 NOVEMBER 08. Nausea during headache, dizziness, sharp pain for 2-3 hours on right side of face. Limited vision and light sensitivity.
Age: 26.0
Sex: M
Vaccine: FLU3
Symptoms: Electromyogram, Lumbar puncture, Nerve conduction studies, Paraesthesia, Red blood cell sedimentation rate
Clinical narrative: Recieved flu vaccine 2 1/2 weeks ago and since that time has had progressive parasthesia of the upper extremeties. Admitted to Hospital 11/15/08, discharged 11/19/08. Guillain Barr syndrome versus transverse myelitis.  2/18/09 Received hospital medical records of 11/15-11/19/2008. FINAL DX: no d/c summary dictated.  Neuro consult: favor transverse myelitis. Records reveal patient experienced progressive tingling/numbness of hands & feet, heaviness of extremities x 2 weeks.  Neuro & Neurosurg consults done.  3/16/09 Received additional hospital medical records of 11/15-11/19/2008. FINAL DX: no d/c summary dictated.   Records consisted of ER records & labs.
Age: 0.33
Sex: F
Vaccine: DTAPIPVHIB, HEP, PNC, RV5
Symptoms: Inappropriate schedule of drug administration, No adverse event
Clinical narrative: Pt. was given first dose of Rotateq vaccine @ 18 weeks of age instead of it being given between 6 and 12 weeks of age. No adverse event noted.
Age: 37.0
Sex: M
Vaccine: HEP, MMR
Symptoms: Eye swelling, Rash, Scrotal swelling
Clinical narrative: 2 DAYS AFTER RECEIVING VACCINES(11/15/08), PT DEVELOPED SOME SWELLING OF BOTH EYES AND SLIGHT RASH WITH SOME SWELLING IN SCROTUM.  ON 11/16/08, BOTH EYES WERE ALMOST COMPLETELY SWOLLEN SHUT AND SWELLING IN SCROTUM AND RASH WORSENED.  PT SEEN BY PVT MD ON 11/17 WHO PRESCRIBED BENADRYL AND MEDROL DOSE PACK.
Age: 49.0
Sex: M
Vaccine: FLU3
Symptoms: Chills, Fatigue, Myalgia, Pain, Pyrexia
Clinical narrative: At 8pm 11hours after vaccine administration experienced muscle aches all over  At 9pm experienced chills and shivering  At 10pm high fever  The next day felt okay but just tired and sore  At time of report, feeling fine
Age: 2.0
Sex: M
Vaccine: DTAPIPVHIB, IPV, MMR, PNC, VARCEL
Symptoms: Inappropriate schedule of drug administration, No adverse event
Clinical narrative: no adverse event