chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 15.0
Sex: F
Vaccine: HPV4, HPV4, MNQ, VARCEL
Symptoms: Thirst, Thyroxine normal, Type 1 diabetes mellitus, Urine ketone body present, Urine leukocyte esterase positive
Clinical narrative: Initial report was received on 22 September 2011 from another manufacturer, report number WAES 1107USA03231. The initial reporter to this manufacturer had been a consumer with additional information received from a health care professional. Verbatim from the report: "Information has been received from a consumer concerning her daughter, a 15 year old female with a history of eczema, diabetes and no drug allergies who in December 2010 (also reported as November 2010), was vaccinated with her first dose of GARDASIL and in November 2010, was vaccinated with her second dose of VARIVAX while her annual physical. Concomitant therapy included LOESTRIN, triamcinolone acetonide, LOCOID LIPOCREAM and montelukast sodium (MSD). The consumer reported that her daughter started having increased thirst approximately on 4-FEB-2011 (reported as about 3 weeks from hospitalization). In February 2011, the daughter was hospitalized from 25-FEB-2011 to 27-FEB-2011. She was in diabetic ketoacidosis (DKA) and diagnosed with diabetes. Insulin was given for AE as treatment. The patient performed blood work and antibody screening. It was reported that the therapy with GARDASIL was discontinued and the AE did not improve. At the time of the report, the patient had not recovered. The office contacted during telephone follow-up could not supply the following information: date of birth, dates of vaccination, lot number, date of events, and recovery status. Additional information was received from medical records regarding a 15 year old female who was vaccinated with the first dose of GARDASIL (Lot #663559/1178Y) on 07-DEC-2010 in the left deltoid. On 01-NOV-2010, the patient had received a VARIVAX (Lot #666857/0750Z) reconstituted with diluent (Lot #E007064) in the right deltoid, and MENACTRA (Lot#U3080AA) in the left deltoid. On 25-FEB-2011, the patient presented to the office with weight loss, vomiting, abdominal pain, excessive urination, excessive thirst, and blurred vision and was diagnosed with diabetic ketoacidosis (DKA)/new onset type 1 likely, and was sent to the hospital. The patient's complete blood count, T4 (1.00 ng/dL), and TSH (1.870 UIU/mL) were normal. Urine was positive for glucose (>=1000 mg/dL), ketones (150 mg/dL), and leukocytes (500 leukocytes/mcl). Serum glucose (fingerstick) was >500 mg/dL and BUN/creatinine ratio was 24. At the time of this report, the patient's outcome was unknown. All available medical records will be provided upon request. Additional information has been requested. Documents held by sender: none.
Age: 15.0
Sex: F
Vaccine: HPV4, HPV4, MNQ, VARCEL
Symptoms: Vision blurred, Vomiting, Weight decreased, White blood cell disorder
Clinical narrative: Initial report was received on 22 September 2011 from another manufacturer, report number WAES 1107USA03231. The initial reporter to this manufacturer had been a consumer with additional information received from a health care professional. Verbatim from the report: "Information has been received from a consumer concerning her daughter, a 15 year old female with a history of eczema, diabetes and no drug allergies who in December 2010 (also reported as November 2010), was vaccinated with her first dose of GARDASIL and in November 2010, was vaccinated with her second dose of VARIVAX while her annual physical. Concomitant therapy included LOESTRIN, triamcinolone acetonide, LOCOID LIPOCREAM and montelukast sodium (MSD). The consumer reported that her daughter started having increased thirst approximately on 4-FEB-2011 (reported as about 3 weeks from hospitalization). In February 2011, the daughter was hospitalized from 25-FEB-2011 to 27-FEB-2011. She was in diabetic ketoacidosis (DKA) and diagnosed with diabetes. Insulin was given for AE as treatment. The patient performed blood work and antibody screening. It was reported that the therapy with GARDASIL was discontinued and the AE did not improve. At the time of the report, the patient had not recovered. The office contacted during telephone follow-up could not supply the following information: date of birth, dates of vaccination, lot number, date of events, and recovery status. Additional information was received from medical records regarding a 15 year old female who was vaccinated with the first dose of GARDASIL (Lot #663559/1178Y) on 07-DEC-2010 in the left deltoid. On 01-NOV-2010, the patient had received a VARIVAX (Lot #666857/0750Z) reconstituted with diluent (Lot #E007064) in the right deltoid, and MENACTRA (Lot#U3080AA) in the left deltoid. On 25-FEB-2011, the patient presented to the office with weight loss, vomiting, abdominal pain, excessive urination, excessive thirst, and blurred vision and was diagnosed with diabetic ketoacidosis (DKA)/new onset type 1 likely, and was sent to the hospital. The patient's complete blood count, T4 (1.00 ng/dL), and TSH (1.870 UIU/mL) were normal. Urine was positive for glucose (>=1000 mg/dL), ketones (150 mg/dL), and leukocytes (500 leukocytes/mcl). Serum glucose (fingerstick) was >500 mg/dL and BUN/creatinine ratio was 24. At the time of this report, the patient's outcome was unknown. All available medical records will be provided upon request. Additional information has been requested. Documents held by sender: none.
Age: 67.0
Sex: F
Vaccine: VARZOS, VARZOS
Symptoms: Acne, Erythema, Pruritus
Clinical narrative: Information has been received from a 67 year old female patient reporting on herself with thyroid issue and a tremor in her hand and no known drug reactions or allergies, who on 23-AUG-2011 was vaccinated subcutaneously in the back of her arm with a dose of ZOSTAVAX (Merck) (dose and lot # not reported). Concomitant therapy included levothyroxine Na, carbidopa/levodopa (manufacturer unspecified) and oxybutynin Chloride. The patient reported that the following day, on 24-AUG-2011, she broke out in a shingles rash on her back and went around her torso to the underside of her breasts. The rash was fading but she still was having some symptoms. The rash was itchy and burning. The patient sought unspecified medical attention. Treatment for the adverse event included unspecified antibiotics and calamine lotion. It was reported that the rash was improving but not all gone. Laboratory and diagnostics studies were not performed. The patient sought unspecified medical attention. At the time of report, the patient had not recovered. Broke out in a shingles rash on her back and went around her torso to the underside of her breasts was considered to be disabling by the consumer because she had not been able to do some of her regular activities such as swimming due to possible contagion. Additional information has been requested.
Age: 67.0
Sex: F
Vaccine: VARZOS, VARZOS
Symptoms: Activities of daily living impaired, Burning sensation, Herpes zoster, Rash, Rash pruritic
Clinical narrative: Information has been received from a 67 year old female patient reporting on herself with thyroid issue and a tremor in her hand and no known drug reactions or allergies, who on 23-AUG-2011 was vaccinated subcutaneously in the back of her arm with a dose of ZOSTAVAX (Merck) (dose and lot # not reported). Concomitant therapy included levothyroxine Na, carbidopa/levodopa (manufacturer unspecified) and oxybutynin Chloride. The patient reported that the following day, on 24-AUG-2011, she broke out in a shingles rash on her back and went around her torso to the underside of her breasts. The rash was fading but she still was having some symptoms. The rash was itchy and burning. The patient sought unspecified medical attention. Treatment for the adverse event included unspecified antibiotics and calamine lotion. It was reported that the rash was improving but not all gone. Laboratory and diagnostics studies were not performed. The patient sought unspecified medical attention. At the time of report, the patient had not recovered. Broke out in a shingles rash on her back and went around her torso to the underside of her breasts was considered to be disabling by the consumer because she had not been able to do some of her regular activities such as swimming due to possible contagion. Additional information has been requested.
Age: 31.0
Sex: F
Vaccine: FLU3, PPV, PPV
Symptoms: Cellulitis, Injection site erythema, Injection site induration, Injection site mass, Injection site pain
Clinical narrative: Information has been received from a pharmacist and a 31 year old female pharmacy technician concerning the female pharmacy technician with hand inflammation, migraine and asthma and with no drug allergy who on 12-SEP-2011 was vaccinated IM with a dose of PNEUMOVAX 23 (Lot number: 671001/0843AA; Expired date: 07-MAR-2013). Concomitant therapy included SPRINTEC and meloxicam. The patient reported that on 13-SEP-2011 her arm became sore and red at the site of injection. The area was "the size of a quarter". The patient could not sleep that night. By the next day, the arm had swelled, and the patient had a raised, hot, red area of "the size of a palm" at the site of injection. The patient also had a fever and nausea. The pharmacist reported that the patient had red, warm, swollen lump at injection site day after immunization, on 13-SEP-2011. The lump progressively got harder, redder and more swollen in next 2 to 3 days. The patient felt sick and feverish. 3 days after injection, the patient went to the physician who diagnosed her with cellulitis. The patient reported that she was also diagnosed with sepsis. The physician gave the patient antibiotics and anti-inflammatories: LEVAQUIN for 5 days, doxycycline (for 10 days), ZOFRAN and promethazine. The patient still had a hard red lump on her arm by "yesterday", on 26-SEP-2011, so the physician gave the patient BACTRIM DS (for 7 days). The patient could hardly stand up and missed 1 week of school and work. The patient reported that she was recovering. The pharmacist reported that the patient still experienced slight pain and tenderness at site 10 days after injection. The patient was no longer feverish. Lump size and hardness was significantly reduced 7 days after antibiotics initiated. (The pharmacist also reported as "the patient had recovered".) Blood test was performed without result. Cellulitis, sepsis and could hardly stand up were considered to be other important medical event. Sepsis was considered to be life threatening by the patient. Could hardly stand up was considered to be disabling. A lot check has been initiated. Additional information has been requested.
Age: 31.0
Sex: F
Vaccine: FLU3, PPV, PPV
Symptoms: Injection site swelling, Injection site warmth, Malaise, Pyrexia
Clinical narrative: Information has been received from a pharmacist and a 31 year old female pharmacy technician concerning the female pharmacy technician with hand inflammation, migraine and asthma and with no drug allergy who on 12-SEP-2011 was vaccinated IM with a dose of PNEUMOVAX 23 (Lot number: 671001/0843AA; Expired date: 07-MAR-2013). Concomitant therapy included SPRINTEC and meloxicam. The patient reported that on 13-SEP-2011 her arm became sore and red at the site of injection. The area was "the size of a quarter". The patient could not sleep that night. By the next day, the arm had swelled, and the patient had a raised, hot, red area of "the size of a palm" at the site of injection. The patient also had a fever and nausea. The pharmacist reported that the patient had red, warm, swollen lump at injection site day after immunization, on 13-SEP-2011. The lump progressively got harder, redder and more swollen in next 2 to 3 days. The patient felt sick and feverish. 3 days after injection, the patient went to the physician who diagnosed her with cellulitis. The patient reported that she was also diagnosed with sepsis. The physician gave the patient antibiotics and anti-inflammatories: LEVAQUIN for 5 days, doxycycline (for 10 days), ZOFRAN and promethazine. The patient still had a hard red lump on her arm by "yesterday", on 26-SEP-2011, so the physician gave the patient BACTRIM DS (for 7 days). The patient could hardly stand up and missed 1 week of school and work. The patient reported that she was recovering. The pharmacist reported that the patient still experienced slight pain and tenderness at site 10 days after injection. The patient was no longer feverish. Lump size and hardness was significantly reduced 7 days after antibiotics initiated. (The pharmacist also reported as "the patient had recovered".) Blood test was performed without result. Cellulitis, sepsis and could hardly stand up were considered to be other important medical event. Sepsis was considered to be life threatening by the patient. Could hardly stand up was considered to be disabling. A lot check has been initiated. Additional information has been requested.
Age: 31.0
Sex: F
Vaccine: FLU3, PPV, PPV
Symptoms: Activities of daily living impaired, Blood test, Cellulitis, Dysstasia, Feeling hot
Clinical narrative: Information has been received from a pharmacist and a 31 year old female pharmacy technician concerning the female pharmacy technician with hand inflammation, migraine and asthma and with no drug allergy who on 12-SEP-2011 was vaccinated IM with a dose of PNEUMOVAX 23 (Lot number: 671001/0843AA; Expired date: 07-MAR-2013). Concomitant therapy included SPRINTEC and meloxicam. The patient reported that on 13-SEP-2011 her arm became sore and red at the site of injection. The area was "the size of a quarter". The patient could not sleep that night. By the next day, the arm had swelled, and the patient had a raised, hot, red area of "the size of a palm" at the site of injection. The patient also had a fever and nausea. The pharmacist reported that the patient had red, warm, swollen lump at injection site day after immunization, on 13-SEP-2011. The lump progressively got harder, redder and more swollen in next 2 to 3 days. The patient felt sick and feverish. 3 days after injection, the patient went to the physician who diagnosed her with cellulitis. The patient reported that she was also diagnosed with sepsis. The physician gave the patient antibiotics and anti-inflammatories: LEVAQUIN for 5 days, doxycycline (for 10 days), ZOFRAN and promethazine. The patient still had a hard red lump on her arm by "yesterday", on 26-SEP-2011, so the physician gave the patient BACTRIM DS (for 7 days). The patient could hardly stand up and missed 1 week of school and work. The patient reported that she was recovering. The pharmacist reported that the patient still experienced slight pain and tenderness at site 10 days after injection. The patient was no longer feverish. Lump size and hardness was significantly reduced 7 days after antibiotics initiated. (The pharmacist also reported as "the patient had recovered".) Blood test was performed without result. Cellulitis, sepsis and could hardly stand up were considered to be other important medical event. Sepsis was considered to be life threatening by the patient. Could hardly stand up was considered to be disabling. A lot check has been initiated. Additional information has been requested.
Age: 31.0
Sex: F
Vaccine: FLU3, PPV, PPV
Symptoms: Injection site erythema, Injection site induration, Injection site mass, Injection site pain, Injection site swelling
Clinical narrative: Information has been received from a pharmacist and a 31 year old female pharmacy technician concerning the female pharmacy technician with hand inflammation, migraine and asthma and with no drug allergy who on 12-SEP-2011 was vaccinated IM with a dose of PNEUMOVAX 23 (Lot number: 671001/0843AA; Expired date: 07-MAR-2013). Concomitant therapy included SPRINTEC and meloxicam. The patient reported that on 13-SEP-2011 her arm became sore and red at the site of injection. The area was "the size of a quarter". The patient could not sleep that night. By the next day, the arm had swelled, and the patient had a raised, hot, red area of "the size of a palm" at the site of injection. The patient also had a fever and nausea. The pharmacist reported that the patient had red, warm, swollen lump at injection site day after immunization, on 13-SEP-2011. The lump progressively got harder, redder and more swollen in next 2 to 3 days. The patient felt sick and feverish. 3 days after injection, the patient went to the physician who diagnosed her with cellulitis. The patient reported that she was also diagnosed with sepsis. The physician gave the patient antibiotics and anti-inflammatories: LEVAQUIN for 5 days, doxycycline (for 10 days), ZOFRAN and promethazine. The patient still had a hard red lump on her arm by "yesterday", on 26-SEP-2011, so the physician gave the patient BACTRIM DS (for 7 days). The patient could hardly stand up and missed 1 week of school and work. The patient reported that she was recovering. The pharmacist reported that the patient still experienced slight pain and tenderness at site 10 days after injection. The patient was no longer feverish. Lump size and hardness was significantly reduced 7 days after antibiotics initiated. (The pharmacist also reported as "the patient had recovered".) Blood test was performed without result. Cellulitis, sepsis and could hardly stand up were considered to be other important medical event. Sepsis was considered to be life threatening by the patient. Could hardly stand up was considered to be disabling. A lot check has been initiated. Additional information has been requested.
Age: 31.0
Sex: F
Vaccine: FLU3, PPV, PPV
Symptoms: Injection site warmth, Insomnia, Malaise, Nausea, Oedema peripheral
Clinical narrative: Information has been received from a pharmacist and a 31 year old female pharmacy technician concerning the female pharmacy technician with hand inflammation, migraine and asthma and with no drug allergy who on 12-SEP-2011 was vaccinated IM with a dose of PNEUMOVAX 23 (Lot number: 671001/0843AA; Expired date: 07-MAR-2013). Concomitant therapy included SPRINTEC and meloxicam. The patient reported that on 13-SEP-2011 her arm became sore and red at the site of injection. The area was "the size of a quarter". The patient could not sleep that night. By the next day, the arm had swelled, and the patient had a raised, hot, red area of "the size of a palm" at the site of injection. The patient also had a fever and nausea. The pharmacist reported that the patient had red, warm, swollen lump at injection site day after immunization, on 13-SEP-2011. The lump progressively got harder, redder and more swollen in next 2 to 3 days. The patient felt sick and feverish. 3 days after injection, the patient went to the physician who diagnosed her with cellulitis. The patient reported that she was also diagnosed with sepsis. The physician gave the patient antibiotics and anti-inflammatories: LEVAQUIN for 5 days, doxycycline (for 10 days), ZOFRAN and promethazine. The patient still had a hard red lump on her arm by "yesterday", on 26-SEP-2011, so the physician gave the patient BACTRIM DS (for 7 days). The patient could hardly stand up and missed 1 week of school and work. The patient reported that she was recovering. The pharmacist reported that the patient still experienced slight pain and tenderness at site 10 days after injection. The patient was no longer feverish. Lump size and hardness was significantly reduced 7 days after antibiotics initiated. (The pharmacist also reported as "the patient had recovered".) Blood test was performed without result. Cellulitis, sepsis and could hardly stand up were considered to be other important medical event. Sepsis was considered to be life threatening by the patient. Could hardly stand up was considered to be disabling. A lot check has been initiated. Additional information has been requested.
Age: 31.0
Sex: F
Vaccine: FLU3, PPV, PPV
Symptoms: Pyrexia, Sepsis
Clinical narrative: Information has been received from a pharmacist and a 31 year old female pharmacy technician concerning the female pharmacy technician with hand inflammation, migraine and asthma and with no drug allergy who on 12-SEP-2011 was vaccinated IM with a dose of PNEUMOVAX 23 (Lot number: 671001/0843AA; Expired date: 07-MAR-2013). Concomitant therapy included SPRINTEC and meloxicam. The patient reported that on 13-SEP-2011 her arm became sore and red at the site of injection. The area was "the size of a quarter". The patient could not sleep that night. By the next day, the arm had swelled, and the patient had a raised, hot, red area of "the size of a palm" at the site of injection. The patient also had a fever and nausea. The pharmacist reported that the patient had red, warm, swollen lump at injection site day after immunization, on 13-SEP-2011. The lump progressively got harder, redder and more swollen in next 2 to 3 days. The patient felt sick and feverish. 3 days after injection, the patient went to the physician who diagnosed her with cellulitis. The patient reported that she was also diagnosed with sepsis. The physician gave the patient antibiotics and anti-inflammatories: LEVAQUIN for 5 days, doxycycline (for 10 days), ZOFRAN and promethazine. The patient still had a hard red lump on her arm by "yesterday", on 26-SEP-2011, so the physician gave the patient BACTRIM DS (for 7 days). The patient could hardly stand up and missed 1 week of school and work. The patient reported that she was recovering. The pharmacist reported that the patient still experienced slight pain and tenderness at site 10 days after injection. The patient was no longer feverish. Lump size and hardness was significantly reduced 7 days after antibiotics initiated. (The pharmacist also reported as "the patient had recovered".) Blood test was performed without result. Cellulitis, sepsis and could hardly stand up were considered to be other important medical event. Sepsis was considered to be life threatening by the patient. Could hardly stand up was considered to be disabling. A lot check has been initiated. Additional information has been requested.
Age: 26.0
Sex: F
Vaccine: TDAP, TDAP
Symptoms: Chest discomfort, Feeling abnormal, Lip swelling, Pruritus
Clinical narrative: Pt is a 26 y.o. female who delivery her baby on 7/30/11. Post partum orders include Tdap vaccine. Pt received vaccine at 2315 on 7/30/11. In AM on 7/31/11 pt complained of swelling of upper lip -feeling like she had been punched in the mouth-, itching, and some chest tightness. Pt received diphenhydramine 50 mg IV x 1. Symptoms resolved. Diphenhydramine was ordered 50 mg IV q6h prn but pt did not require any additional doses. Pt discharged on 8/1/11.
Age: 26.0
Sex: F
Vaccine: TDAP, TDAP
Symptoms: Chest discomfort, Lip swelling, Pruritus
Clinical narrative: Pt is a 26 y.o. female who delivery her baby on 7/30/11. Post partum orders include Tdap vaccine. Pt received vaccine at 2315 on 7/30/11. In AM on 7/31/11 pt complained of swelling of upper lip -feeling like she had been punched in the mouth-, itching, and some chest tightness. Pt received diphenhydramine 50 mg IV x 1. Symptoms resolved. Diphenhydramine was ordered 50 mg IV q6h prn but pt did not require any additional doses. Pt discharged on 8/1/11.
Age: 0.24
Sex: M
Vaccine: HIBV
Symptoms: Constipation, Crying, Irritability, Pain, Pyrexia
Clinical narrative: Fever ~101 degrees F for ~40 hours after shot. Controlled with infant advil and acetaminophen (Triaminic) from duration of shot for 2 days after. Screaming and crying in middle of night after first night. Extreme constipation with obvious symptoms of pain since then. BM frequency is ~ 1/10 days, and in most cases must be induced with glycerin suppository, due to fussiness of child.
Age: 0.24
Sex: M
Vaccine: HIBV
Symptoms: Screaming
Clinical narrative: Fever ~101 degrees F for ~40 hours after shot. Controlled with infant advil and acetaminophen (Triaminic) from duration of shot for 2 days after. Screaming and crying in middle of night after first night. Extreme constipation with obvious symptoms of pain since then. BM frequency is ~ 1/10 days, and in most cases must be induced with glycerin suppository, due to fussiness of child.
Age: 65.0
Sex: M
Vaccine: FLU3
Symptoms: Deafness unilateral, Tinnitus
Clinical narrative: At 9:30am I had the Flu Vaccine administered. Two hours after vaccination, at 11:30am, I was completely deaf in my left ear. Today is October 3, 2011 and I am still completely deaf in my left ear. There is a constant ringing (white noise) that will not stop.  It never goes away. This has taken place since my hearing loss after the vaccination.
Age: 92.0
Sex: F
Vaccine: FLU3
Symptoms: Facial pain, Mass, Swelling face
Clinical narrative: Flu shot given. 4 hours later pt called asking about swelling, lump that was sore on her face near left ear & jaw. Not red.
Age: 35.0
Sex: M
Vaccine: FLUN3, TYP
Symptoms: Computerised tomogram, Dizziness, Loss of consciousness, Nuclear magnetic resonance imaging, Paraesthesia oral
Clinical narrative: Service member presented to the clinic with generalized itching, tingling of the tongue, dizziness & throat swelling, loss consciousness, emergency procedures were initiated - sent to local hospital after being stabilized on 29 Sep 2011. He is still hospitalized & stable. Still cause is unknown.
Age: 35.0
Sex: M
Vaccine: FLUN3, TYP
Symptoms: Pharyngeal oedema, Pruritus generalised
Clinical narrative: Service member presented to the clinic with generalized itching, tingling of the tongue, dizziness & throat swelling, loss consciousness, emergency procedures were initiated - sent to local hospital after being stabilized on 29 Sep 2011. He is still hospitalized & stable. Still cause is unknown.
Age: 0.69
Sex: M
Vaccine: DTAPIPVHIB, HEP, PNC13
Symptoms: Urticaria
Clinical narrative: 1 hour after shots - urticarial rash and ? gasping for air, seen in ED. Symptoms resolved in about 1 hour later. 1 dose BENADRYL given.
Age: 0.34
Sex: F
Vaccine: DTAPHEPBIP, HIBV, PNC13, RV1
Symptoms: Blood culture, CSF cell count, CSF culture, CSF glucose, CSF protein
Clinical narrative: Pt had fever of 102-103 and a seizure occurred the same day as vaccine administration. No illness noted prior to vaccinations.
Age: 0.34
Sex: F
Vaccine: DTAPHEPBIP, HIBV, PNC13, RV1
Symptoms: Chest X-ray, Computerised tomogram head, Convulsion, Full blood count, Gram stain
Clinical narrative: Pt had fever of 102-103 and a seizure occurred the same day as vaccine administration. No illness noted prior to vaccinations.
Age: 0.34
Sex: F
Vaccine: DTAPHEPBIP, HIBV, PNC13, RV1
Symptoms: Metabolic function test, Nuclear magnetic resonance imaging brain, Pyrexia
Clinical narrative: Pt had fever of 102-103 and a seizure occurred the same day as vaccine administration. No illness noted prior to vaccinations.
Age: 65.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site erythema, Injection site mass, Injection site pain, Injection site reaction, Injection site warmth
Clinical narrative: Large welt & raised knot where injection given, red & hot to touch. Painful. Per patient, started morning of injection. Size: baseball size.
Age: 65.0
Sex: F
Vaccine: VARZOS
Symptoms: Urticaria
Clinical narrative: Large welt & raised knot where injection given, red & hot to touch. Painful. Per patient, started morning of injection. Size: baseball size.
Age: 20.0
Sex: F
Vaccine: RAB
Symptoms: Dizziness, Feeling abnormal, Headache, Heart rate increased, Injection site pain
Clinical narrative: Approx 4 hrs after receiving (RABAVERT) inj, day 7, started having a headache, increased heart rate, nausea, dizziness, felt shaky & pain at injection site. Vision became impaired & pt states I felt like a bus ran over me. The symptoms came in waves.
Age: 20.0
Sex: F
Vaccine: RAB
Symptoms: Nausea, Nervousness, Visual impairment
Clinical narrative: Approx 4 hrs after receiving (RABAVERT) inj, day 7, started having a headache, increased heart rate, nausea, dizziness, felt shaky & pain at injection site. Vision became impaired & pt states I felt like a bus ran over me. The symptoms came in waves.
Age: 9.0
Sex: U
Vaccine: HPV4
Symptoms: Blood aluminium increased, Carbohydrate intolerance, Coeliac disease, Eating disorder, Hypoaesthesia
Clinical narrative: Information has been received from a consumer concerning "thousands of children" some as young 9 years old or 10 years old, who on unspecified dates were vaccinated with a dose of GARDASIL (lot #, dose and route not reported). The consumer reported that on an unspecified date thousands of children were sending reports to her website about the following side effects, vomiting, weight loss, inability to eat anything with gluten, sugar, preservatives or carbohydrates, numbness in their feet, in bed for months and toxic level of aluminum. At the time of this report the patients had not recovered. This is one of several reports received from the same source. Vomiting, weight loss, could not eat anything with gluten, sugar, preservatives or carbohydrates, numbness in their feet, in bed for months and toxic level of aluminum were considered to be disabling and immediately life-threatening. Attempts to validate the identity of the patients are not possible. Additional information is not expected.
Age: 9.0
Sex: U
Vaccine: HPV4
Symptoms: Mobility decreased, Reaction to preservatives, Toxicologic test abnormal, Vomiting, Weight decreased
Clinical narrative: Information has been received from a consumer concerning "thousands of children" some as young 9 years old or 10 years old, who on unspecified dates were vaccinated with a dose of GARDASIL (lot #, dose and route not reported). The consumer reported that on an unspecified date thousands of children were sending reports to her website about the following side effects, vomiting, weight loss, inability to eat anything with gluten, sugar, preservatives or carbohydrates, numbness in their feet, in bed for months and toxic level of aluminum. At the time of this report the patients had not recovered. This is one of several reports received from the same source. Vomiting, weight loss, could not eat anything with gluten, sugar, preservatives or carbohydrates, numbness in their feet, in bed for months and toxic level of aluminum were considered to be disabling and immediately life-threatening. Attempts to validate the identity of the patients are not possible. Additional information is not expected.
Age: 15.0
Sex: F
Vaccine: FLU3, HPV4
Symptoms: Electroencephalogram normal, Seizure like phenomena
Clinical narrative: Information has been received from a physician concerning a 16 year old female who on 01-JUL-2009 was vaccinated with the first dose of GARDASIL (lot #, dose and route not reported) along with Td, MENACTRA and a second dose of VARIVAX. The physician reported that the female patient was seen for seizure activity which developed at an unspecified date after her second dose of GARDASIL on 19-MAR-2010 along with an unidentified manufacturer's brand of influenza vaccine (manufacturer unknown). She had not received the third dose of GARDASIL. On 01-NOV-2010, this female patient had an electroencephalogram for "seizure activity" but the doctors could not find "an answer". No treatment was given for the event. At some time after this test, the child's mother called physician because she thought the seizure activity might be caused by the GARDASIL. At the time of the report, the patient had not recovered. Upon internal review, seizure activity was determined to be an other important medical event. Additional information has been requested.
Age: 24.0
Sex: F
Vaccine: HPV4
Symptoms: Abortion spontaneous, Infertility female, Maternal exposure before pregnancy, Maternal exposure during pregnancy, Smear cervix abnormal
Clinical narrative: Information has been received from a patient for GARDASIL, a Pregnancy Registry product, concerning herself, a 24 year old female with penicillin allergy and related family with a history of 4 pregnancies and 2 live births who in 2007 was vaccinated with all the GARDASIL series SQ (Lot # and expiration not reported). Concomitant therapy included "non steroidal inhaler". Consumer reported that she became pregnant after her first dose of GARDASIL in 2007. Nurse administered the second dose of GARDASIL series in July 2007 and then she had a miscarriage between 2nd dose in August 2007 (Lot # and expiration not reported). She was in the hospital for miscarriage (date unspecified) and was unaware of any lab or tests performed. Nurse told the patient it was safe to receive second dose. The consumer received third dose of GARDASIL series (Lot # and expiration not reported she believed in November 2007). The consumer was on birth control for a short time but she had not been taking birth control for the past year (in 2010) and was unable to get pregnant. Also reported that after her miscarriage she had an abnormal PAP (date unspecified) which had never had before receiving GARDASIL series. It was reported that the patient had two live births and two she chose not to keep before receiving the GARDASIL series. The patient sought unspecified medical attention. Additional information has been requested.
Sex: F
Vaccine: HPV4
Symptoms: Bedridden, Biopsy, Blood aluminium increased, Blood test, Carbohydrate intolerance
Clinical narrative: Information has been received from a consumer concerning her daughter, who on an unspecified date was vaccinated with a first dose of GARDASIL (lot #, dose and route not reported). The mother reported that on an unspecified date her daughter experienced vomiting within 12 hours of receiving her first dose of the vaccine. The vomiting had not stopped since then. The consumer reported that her daughter had 90% of the post-marketing side effects in the prescribing information. On an unspecified date her daughter experienced a 30 pound weight loss and could no longer eat anything with gluten, sugar, preservatives or carbohydrates. She was starting to experience numbness in both feet. At some unidentified time her daughter was in bed for 5 months. She also reported that her daughter had a toxic level of aluminum in her system. She was hospitalized for 17 days; lab diagnostic studies included biopsy, spinal taps and unspecified blood tests (results not provided). At the time of the report the patient had not recovered from the adverse events. Vomiting, weight loss, could not eat anything with gluten, sugar, preservatives or carbohydrates, numbness in her feet, was in bed for 5 months and toxic level of aluminum were considered to be disabling and immediately life-threatening. This is one of several reports received from the same source. Additional information is not expected.
Sex: F
Vaccine: HPV4
Symptoms: Coeliac disease, Glucose tolerance impaired, Hypoaesthesia, Lumbar puncture, Mobility decreased
Clinical narrative: Information has been received from a consumer concerning her daughter, who on an unspecified date was vaccinated with a first dose of GARDASIL (lot #, dose and route not reported). The mother reported that on an unspecified date her daughter experienced vomiting within 12 hours of receiving her first dose of the vaccine. The vomiting had not stopped since then. The consumer reported that her daughter had 90% of the post-marketing side effects in the prescribing information. On an unspecified date her daughter experienced a 30 pound weight loss and could no longer eat anything with gluten, sugar, preservatives or carbohydrates. She was starting to experience numbness in both feet. At some unidentified time her daughter was in bed for 5 months. She also reported that her daughter had a toxic level of aluminum in her system. She was hospitalized for 17 days; lab diagnostic studies included biopsy, spinal taps and unspecified blood tests (results not provided). At the time of the report the patient had not recovered from the adverse events. Vomiting, weight loss, could not eat anything with gluten, sugar, preservatives or carbohydrates, numbness in her feet, was in bed for 5 months and toxic level of aluminum were considered to be disabling and immediately life-threatening. This is one of several reports received from the same source. Additional information is not expected.
Sex: F
Vaccine: HPV4
Symptoms: Reaction to preservatives, Toxicologic test abnormal, Vomiting, Weight decreased
Clinical narrative: Information has been received from a consumer concerning her daughter, who on an unspecified date was vaccinated with a first dose of GARDASIL (lot #, dose and route not reported). The mother reported that on an unspecified date her daughter experienced vomiting within 12 hours of receiving her first dose of the vaccine. The vomiting had not stopped since then. The consumer reported that her daughter had 90% of the post-marketing side effects in the prescribing information. On an unspecified date her daughter experienced a 30 pound weight loss and could no longer eat anything with gluten, sugar, preservatives or carbohydrates. She was starting to experience numbness in both feet. At some unidentified time her daughter was in bed for 5 months. She also reported that her daughter had a toxic level of aluminum in her system. She was hospitalized for 17 days; lab diagnostic studies included biopsy, spinal taps and unspecified blood tests (results not provided). At the time of the report the patient had not recovered from the adverse events. Vomiting, weight loss, could not eat anything with gluten, sugar, preservatives or carbohydrates, numbness in her feet, was in bed for 5 months and toxic level of aluminum were considered to be disabling and immediately life-threatening. This is one of several reports received from the same source. Additional information is not expected.
Age: 0.21
Sex: F
Vaccine: DTAPIPVHIB, HEP, PNC, RV5
Symptoms: Abdominal X-ray, Enema administration, Haematochezia, Laboratory test normal, Occult blood positive
Clinical narrative: Information has been received from a physician concerning a 12 week female with down's syndrome and no drug reactions or allergies who on 27-MAY-2011 was vaccinated orally with a dose of ROTATEQ (lot # and dose not reported). There was no concomitant medication. On 09-JUN-2011, the patient experienced hematochezia after receiving the ROTATEQ. The patient's parent called to seek medical attention. No treatment was given for the event. No lab diagnostics studies were performed. At the time of the report, the patient had recovered. Follow-up information was received from a registered nurse indicating that on 27-MAY-2011, the patient received the first dose of ROTATEQ (Lot # 669523/1556Z) and concomitantly received the second dose of hepatitis B virus vaccine (Lot # 669597/0294AA, thimerosal free), and the patient received the first dose of PREVNAR and the first dose of PENTACEL. On 09-JUN-2011, the patient's mother called the physician to report that the patient had "a lot of blood in her stools". The patient was seen by the physician and was referred to a General Surgeon. The patient was taken to a Medical Center. The patient had a short-term admission, overnight for observation. The patient tested positive for blood in her stools. The patient had a KUB with an air enema. There was no report of intussusception. The patient's labs were normal. ROTATEQ was not discontinued. On 05-AUG-2011, the patient received the second dose of ROTATEQ (Lot # 669764/0776AA). The patient had no adverse reaction. On 06-SEP-2011, the patient received the third dose of ROTATEQ (Lot # 669476/1529Z). On 17-SEP-2011, the patient had three diapers with blood in her stools. The patient was admitted to Medical Center. The patient had a three view Abdominal x-ray which revealed normal bowel gas patterns. The patient was discharged from the hospital. The patient had recovered. This is one of several reports received from the same source. Additional information has been requested.
Age: 0.21
Sex: F
Vaccine: DTAPIPVHIB, HEP, PNC, RV5
Symptoms: Urinary system X-ray, Vaccine positive rechallenge, X-ray normal
Clinical narrative: Information has been received from a physician concerning a 12 week female with down's syndrome and no drug reactions or allergies who on 27-MAY-2011 was vaccinated orally with a dose of ROTATEQ (lot # and dose not reported). There was no concomitant medication. On 09-JUN-2011, the patient experienced hematochezia after receiving the ROTATEQ. The patient's parent called to seek medical attention. No treatment was given for the event. No lab diagnostics studies were performed. At the time of the report, the patient had recovered. Follow-up information was received from a registered nurse indicating that on 27-MAY-2011, the patient received the first dose of ROTATEQ (Lot # 669523/1556Z) and concomitantly received the second dose of hepatitis B virus vaccine (Lot # 669597/0294AA, thimerosal free), and the patient received the first dose of PREVNAR and the first dose of PENTACEL. On 09-JUN-2011, the patient's mother called the physician to report that the patient had "a lot of blood in her stools". The patient was seen by the physician and was referred to a General Surgeon. The patient was taken to a Medical Center. The patient had a short-term admission, overnight for observation. The patient tested positive for blood in her stools. The patient had a KUB with an air enema. There was no report of intussusception. The patient's labs were normal. ROTATEQ was not discontinued. On 05-AUG-2011, the patient received the second dose of ROTATEQ (Lot # 669764/0776AA). The patient had no adverse reaction. On 06-SEP-2011, the patient received the third dose of ROTATEQ (Lot # 669476/1529Z). On 17-SEP-2011, the patient had three diapers with blood in her stools. The patient was admitted to Medical Center. The patient had a three view Abdominal x-ray which revealed normal bowel gas patterns. The patient was discharged from the hospital. The patient had recovered. This is one of several reports received from the same source. Additional information has been requested.
Age: 90.0
Sex: F
Vaccine: FLU3
Symptoms: Loss of consciousness, Pain
Clinical narrative: Initial report received on 20 September 2011 from a health professional. A 90 year old female patient, whose medical history and concomitant medications were not reported, received a dose of FLUZONE HIGH DOSE (lot number not reported) on an unspecified date. An unspecified amount of time later, the patient had complaints of aches and pains and she had passed out when trying to get out of bed. The day following vaccination, she was hospitalized and was there for three days. The patient's outcome was not reported. The reporter for this case is the same as for case number 2011-09075. Documents held by sender: None.
Age: 84.0
Sex: M
Vaccine: FLU3
Symptoms: Pain
Clinical narrative: Initial report received on 20 September 2011 from a health professional. An 84 year old male patient, whose medical history and concomitant medications were not reported, received a dose of FLUZONE HIGH DOSE (lot number not reported) on an unspecified date. An unspecified amount of time later, the patient had complaints of aches and pains. Three days after vaccination, he was hospitalized. The patient's outcome was not reported. The reporter for this case is the same as for case number 2011-09073. Documents held by sender: None.
Sex: U
Vaccine: DTAP
Symptoms: Death, Laboratory test normal, Pulmonary haemorrhage
Clinical narrative: Initial case retrieved from the scientific literature on 22 September 2011. The authors evaluated clinical-pathological features of 37 infants/children whose parents alleged a relationship between vaccination and death or permanent central nervous system (CNS) damage, and sought compensation through the National Vaccine Injury Compensation Program during the years from 1990 through 1999. CNS tissue was available for evaluation by a pediatric neuropathologist in these 37 cases: 23 males (62%) and 14 females (38%) ranging in age from 1 month to 17 years at the time of death or biopsy. Thirty-three of the 37 patients were dead at the time the case was evaluated. Most commonly implicated vaccines were DTP or DTAP (33 cases), followed by MMR and IPV/OPV (25 cases each). The authors concluded that there was no obvious relationship between type of vaccine (or vaccines simultaneously administered) to time of onset of symptoms, nature of symptoms, or the lesions found. No CNS lesions were found in 5 of 37 cases. There were a variety of CNS lesions amongst the 32 remaining cases, but pathogenesis of the majority was apparent and not considered a complication of vaccination. Of the 37 patients described in the article, the vaccines received by eight of these patients were specified. This case captures one patient; and the other seven patients are captured in case numbers 2011-09243, -09245, -09246, -09247, -09248, -09249 and 2011-09250. An unidentified patient (infant/child, age not reported) had received a DTAP vaccine (manufacturer unknown; lot number, route, site and date of administration not reported) and within three days of vaccination, the patient died. Cause of death was pulmonary hemorrhage (onset not reported) although pathogenesis of the hemorrhage remained undefined. No CNS lesions were identified. Documents held by sender: None.
Age: 3.0
Sex: F
Vaccine: FLUX
Symptoms: Autopsy, Cardio-respiratory arrest, Convulsion, Death, Hypoxia
Clinical narrative: Initial case retrieved from the scientific literature on 22 September 2011.The authors evaluated clinical-pathological features of 37 infants/children whose parents alleged a relationship between vaccination and death or permanent central nervous system (CNS) damage, and sought compensation through the National vaccine Injury Compensation Program during the years from 1990 through 1999. CNS tissue was available for evaluation by a pediatric neuropathologist in these 37 cases: 23 males (62%) and 14 females (38%) ranging in age from 1 month to 17 years at the time of death or biopsy. Thirty-three of the 37 patients were dead at the time the case was evaluated. Most commonly implicated vaccines were DTP or DTAP (33 cases), followed by MMR and IPV/OPV (25 cases each). The authors concluded that there was no obvious relationship between type of vaccine (or vaccines simultaneously administered) to time of onset of symptoms, nature of symptoms, or the lesions found. No CNS lesions were found in 5 of 37 cases. There were a variety of CNS lesions amongst the 32 remaining cases, but pathogenesis of the majority was apparent and not considered a complication of vaccination. Of the 37 patients described in the article, the vaccines received by eight of these patients were specified. This case captures one patient; and the other seven patients are captured in case numbers 2011-09242, -09243, -09246, -09247, -09248, -09249 and 2011-09250. A three-year-old female patient (who was one of triplets) and who had a history of developmental delay, microcephalic, and recurrent CNS infections by unidentified agents which were thought to have been viral, had received an INFLUENZA VACCINE (manufacturer unknown; lot number, route, site and date of administration not reported) when she was 3 years 9 months old. Two weeks later, she presented with CNS symptoms similar to those she had had unassociated with vaccination in the past, including fever. The day following hospitalization, she had a seizure which proceeded to status epilepticus and cardio-respiratory arrest. Respirator therapy was terminated on the following day. Postmortem examination disclosed acute hypoxic-ischemic encephalomyelopathy, noted to have been secondary to status epilepticus. Documents held by sender: None.