chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 64.0
Sex: F
Vaccine: VARZOS
Symptoms: Headache, Injection site pain
Clinical narrative: This spontaneous report as received from a 64 years old female consumer with COMPAZINE allergy and no other pertinent medical history refers to herself. The patient was vaccinated with a dose of ZOSTAVAX on 08-AUG-2012. No other co-suspects were reported. No concomitant medications were reported. On 08-AUG-2012, a few hours after vaccination, the patient experienced headache and injection site soreness. The patient had been taking TYLENOL. But it was not relieving her headache. The patient had not sought any medical attention. No lab diagnostics studies performed. At the time of the report, the patient had not recovered. Additional information is not expected.
Sex: U
Vaccine: VARCEL
Symptoms: Dizziness, Swollen tongue
Clinical narrative: This spontaneous report as received from a pharmacist refers to a patient of unknown age. The patient was vaccinated with VARIVAX (Merck) (lot # reported as H006530, exp date 09-MAR-2014) on an unknown date. On an unknown date the patient experienced swelling of the tongue and dizziness. The patient sought for medical attention via unspecified contact. The outcome was unknown. This is one of several reports received from the same source. Additional information has been requested.
Age: 4.0
Sex: F
Vaccine: DTAPIPV, MMR, VARCEL
Symptoms: Rash
Clinical narrative: This spontaneous report was received from a nurse practitioner via a sales representative concerning her grandchild (gender and age was not provided), who on an unknown date was vaccinated with a dose of VARIVAX (Merck) (route, dose, lot number and expiration date were not provided). No other co-suspects were reported. No concomitant medications were reported. The nurse stated that her grandchild experienced rash after receiving the vaccine and was given unspecified antiviral treatment for the event. At the time of the report, the patient's outcome was not provided. Additional information has been requested.
Age: 5.0
Sex: M
Vaccine: MMR, VARCEL
Symptoms: Expired drug administered, No adverse event
Clinical narrative: This spontaneous report as received from a registered nurse refers to a 5 year old patient. The nurse reported that the patient received a dose of 0.5 ml expired VARIVAX (Merck) (lot # 668253/0926Z; Expire date 15-JUL-2012) subcutaneous on 19-JUL-2012. No adverse effect was reported. This is one of several reports received from the same source3. No further information is available.
Age: 1.26
Sex: M
Vaccine: MMR
Symptoms: Adenoidectomy, Convulsion, Eczema, Electroencephalogram, Milk allergy
Clinical narrative: Information has been received from a consumer concerning her 15 month old son with level 6 food allergy, gluten allergy and no drug reactions/allergies who on 17-APR-2007 was vaccinated with a 0.5 ml dose of MMR II (Lot# not reported). Concomitant therapy included unspecified medication for the patient's food allergy. On approximately 19-APR-2007, "a couple of days after getting the vaccine", the patient developed a rash. The rash got worse, he started swelling and was taken to the Emergency Room but was not admitted. He later developed eczema and had a fever that lasted 7-8 days. The reporter mentioned that her son "now gets the fever every month or so" and would go "in and out" of the hospital, but was not admitted, except for the time that he was admitted for 3-4 days for an allergic reaction to milk. Between 2007 and 2008 he was at the Emergency Room 12 times for fevers and seizures and unexplained vomiting. On an unknown date the patient had been admitted to the hospital due to fevers and seizures (length of stay unspecified). On 25-JUN-2009, the patient was admitted to the hospital for 3-4 days because of seizures. His last seizure was on 25-MAR-2010 at 5:00 a.m. and his last seizure before this one was in November or December 2009. It was also noted that the patient recently had his adenoids removed to help with the fevers. He still had the rashes and eczema. On an unknown date an EEG (electroencephalogram) for 24 hours was performed with no results provided. At the time of the report, the patient had improved but had not recovered. Follow-up information has been received from a consumer concerning her 15 month old son with egg and various other food allergies and a medical history of asthma, Celiac disease, eosinophilic esophagitis and other unspecified conditions who on 02-AUG-2007 was vaccinated with MMR II "0.5 milliliter/one-injection" (site and lot number not reported). The patient was taking "unspecified medications" concomitantly. The mother reported her son is experiencing an ongoing fever due to several vaccinations her son received. The child received PROQUAD (Merck) and VARIVAX (Merck) (dates, route, site and lot numbers not reported for these) & MMR II. The patient's mother said the physician's were not aware the patient had allergies to eggs and components of the vaccine. Her son has seen at least fourteen physicians and "been to many hospitals" and was treated with "different types of medications". At the time of this report, the patient's condition was not recovered. Upon internal review, seizures (2007, 25-JUN-2009, November 2009, 25-MAR-2010) were determined to be medically significant events. Additional information has been requested.
Age: 1.26
Sex: M
Vaccine: MMR
Symptoms: Pyrexia, Rash, Swelling, Vomiting
Clinical narrative: Information has been received from a consumer concerning her 15 month old son with level 6 food allergy, gluten allergy and no drug reactions/allergies who on 17-APR-2007 was vaccinated with a 0.5 ml dose of MMR II (Lot# not reported). Concomitant therapy included unspecified medication for the patient's food allergy. On approximately 19-APR-2007, "a couple of days after getting the vaccine", the patient developed a rash. The rash got worse, he started swelling and was taken to the Emergency Room but was not admitted. He later developed eczema and had a fever that lasted 7-8 days. The reporter mentioned that her son "now gets the fever every month or so" and would go "in and out" of the hospital, but was not admitted, except for the time that he was admitted for 3-4 days for an allergic reaction to milk. Between 2007 and 2008 he was at the Emergency Room 12 times for fevers and seizures and unexplained vomiting. On an unknown date the patient had been admitted to the hospital due to fevers and seizures (length of stay unspecified). On 25-JUN-2009, the patient was admitted to the hospital for 3-4 days because of seizures. His last seizure was on 25-MAR-2010 at 5:00 a.m. and his last seizure before this one was in November or December 2009. It was also noted that the patient recently had his adenoids removed to help with the fevers. He still had the rashes and eczema. On an unknown date an EEG (electroencephalogram) for 24 hours was performed with no results provided. At the time of the report, the patient had improved but had not recovered. Follow-up information has been received from a consumer concerning her 15 month old son with egg and various other food allergies and a medical history of asthma, Celiac disease, eosinophilic esophagitis and other unspecified conditions who on 02-AUG-2007 was vaccinated with MMR II "0.5 milliliter/one-injection" (site and lot number not reported). The patient was taking "unspecified medications" concomitantly. The mother reported her son is experiencing an ongoing fever due to several vaccinations her son received. The child received PROQUAD (Merck) and VARIVAX (Merck) (dates, route, site and lot numbers not reported for these) & MMR II. The patient's mother said the physician's were not aware the patient had allergies to eggs and components of the vaccine. Her son has seen at least fourteen physicians and "been to many hospitals" and was treated with "different types of medications". At the time of this report, the patient's condition was not recovered. Upon internal review, seizures (2007, 25-JUN-2009, November 2009, 25-MAR-2010) were determined to be medically significant events. Additional information has been requested.
Age: 15.0
Sex: M
Vaccine: HEPA, HPV4, HEPA, HPV4
Symptoms: Dizziness, Hypoaesthesia oral
Clinical narrative: This report was identified from a line listing obtained on request by the Company from the FDA under the Freedom of Information Act. A 15 years old male patient. The patient was vaccinated IM into the left arm with the first dose of GARDASIL (lot # (672233/1561AA) and expiration date 26-AUG-2014 00:00) on 13-MAR-2012. Suspect therapy given subcutaneously IM into right arm with the second dose of VAQTA (lot#672226/1441AA and expiration date 09-AUG-2014 00:00). On 13-MAR-2012 the patient was feeling dizziness with intermittent numbness of lips after receiving immunization. No syncope. Vitals normal. Patient was alert and oriented. No treatment information was reported. The outcome of events were unknown. The original reporting source was not provided. Additional information is not expected.
Age: 17.0
Sex: F
Vaccine: HPV4, MNQ, HPV4, MNQ
Symptoms: Hyperhidrosis, Pallor, Presyncope
Clinical narrative: This report was identified from a line listing obtained on request by the Company from the FDA under the Freedom of Information Act. On 16-MAR-2012, a 17 years old female patient was vaccinated with the third dose of GARDASIL in the left arm (lot # 672547/1745AA). Concomitant medications included: MENACTRA (lot # U3906AB, the second dose, right arm, intramuscular). About 5 minutes after receiving vaccines the patient became pale & diaphoretic & near syncopal. The patient had to lie down & drink cold water & rest for episode to resolve. The patient sought medical attention by ER visit. The event was considered to be non serious. The original reporting source was not provided. The VAERS ID # is 452037. No further information is available.
Age: 14.0
Sex: F
Vaccine: HPV4, HPV4
Symptoms: Myalgia, Neck pain, Tremor
Clinical narrative: This report was identified from a line listing obtained on request by the Company from the FDA under the Freedom of Information Act. A 14 years old female patient with allergy to CEFZIL and no preexisting illness was vaccinated with lot # (1497AA) dose 1 GARDASIL into left arm on Monday 12-MAR-2012. No concomitant medications were taken. Patient began on the following Tuesday night with hand tremors at rest which continued into Wednesday and Thursday. No tremors on Friday 16-MAR-2012. Patient also complained of sore neck and back muscles. No treatment or lab test. The outcome of sore neck and back muscles was unknown. The patient did not seek medical attention. The report was considered to be non serious. The original reporting source was not provided. Additional information is not expected.
Age: 13.0
Sex: F
Vaccine: HPV4, HPV4
Symptoms: Condition aggravated, Conjunctivitis, Lip swelling, Mycoplasma test positive, Oedema mouth
Clinical narrative: This report was identified from a line listing obtained on request by the Company from the FDA under the Freedom of Information Act. A 13 years old female patient was vaccinated IM on the left arm with the first dose of GARDASIL (lot# 0121AE) on 15-MAR-2012. No other co-suspects were reported. No concomitant medications were reported. On 17-MAR-2012 the patient experienced swollen macerated lips and oral mucosa and severe conjunctivitis. Patient had seen physician on 20-MAR-2012 and was sent to emergency room. Patient was admitted to hospital for 3 days and diagnosed with Stevens - Johnson syndrome and mycoplasma pneumoniae, a known cause of S-J Syndrome. The following information was obtained through follow-up and/or provided by the government. 4/13/12. Hospital records DOS 3/20-23/2012. Patient was diagnosed with: conjunctivitis, Johnson-Stevens erythema multiforme exudative, mouth pain, cough, eye swelling, conjunctivitis, lip dryness/swelling, watery eyes, injection site redness (resolved prior to administration), mouth pain, ulcerations in mouth, fever, pulmonary embolism, peeling, red, dry cracked lips; conjunctival erythema. Patient was admitted et responded to prescription. The patient was discharged in stable condition. Positive mycoplasma titres were performed. The following information was obtained through follow-up and/or provided by the government. 4/13/12: Mycoplasma Ab IgM 3.33 u/l (H), ESR 110 mm/hr (H), CRP 4.3 mg/dl (H), WBC 19 K/mm3 (H), neuts 85% (H), lymphs 7% (l), pit 435 K/mm3 (H), T prot 8.4 g/dl (H) and CXR with a result of RUI infiltrate & possible associated R hilar lymphadenopathy. There was illness at the time of vaccination: cough, which was later confirmed to be mycoplasma pneumoniae. The following information was obtained through follow-up and/or provided by the government on 4/13/12 Hospital records, coughing; URI. No further information is available.
Age: 13.0
Sex: F
Vaccine: HPV4, HPV4
Symptoms: Pneumonia mycoplasmal, Stevens-Johnson syndrome
Clinical narrative: This report was identified from a line listing obtained on request by the Company from the FDA under the Freedom of Information Act. A 13 years old female patient was vaccinated IM on the left arm with the first dose of GARDASIL (lot# 0121AE) on 15-MAR-2012. No other co-suspects were reported. No concomitant medications were reported. On 17-MAR-2012 the patient experienced swollen macerated lips and oral mucosa and severe conjunctivitis. Patient had seen physician on 20-MAR-2012 and was sent to emergency room. Patient was admitted to hospital for 3 days and diagnosed with Stevens - Johnson syndrome and mycoplasma pneumoniae, a known cause of S-J Syndrome. The following information was obtained through follow-up and/or provided by the government. 4/13/12. Hospital records DOS 3/20-23/2012. Patient was diagnosed with: conjunctivitis, Johnson-Stevens erythema multiforme exudative, mouth pain, cough, eye swelling, conjunctivitis, lip dryness/swelling, watery eyes, injection site redness (resolved prior to administration), mouth pain, ulcerations in mouth, fever, pulmonary embolism, peeling, red, dry cracked lips; conjunctival erythema. Patient was admitted et responded to prescription. The patient was discharged in stable condition. Positive mycoplasma titres were performed. The following information was obtained through follow-up and/or provided by the government. 4/13/12: Mycoplasma Ab IgM 3.33 u/l (H), ESR 110 mm/hr (H), CRP 4.3 mg/dl (H), WBC 19 K/mm3 (H), neuts 85% (H), lymphs 7% (l), pit 435 K/mm3 (H), T prot 8.4 g/dl (H) and CXR with a result of RUI infiltrate & possible associated R hilar lymphadenopathy. There was illness at the time of vaccination: cough, which was later confirmed to be mycoplasma pneumoniae. The following information was obtained through follow-up and/or provided by the government on 4/13/12 Hospital records, coughing; URI. No further information is available.
Age: 13.0
Sex: F
Vaccine: HPV4, HPV4
Symptoms: C-reactive protein increased, Chapped lips, Cheilitis, Chest X-ray abnormal, Condition aggravated
Clinical narrative: This report was identified from a line listing obtained on request by the Company from the FDA under the Freedom of Information Act. A 13 years old female patient was vaccinated IM on the left arm with the first dose of GARDASIL (lot# 0121AE) on 15-MAR-2012. No other co-suspects were reported. No concomitant medications were reported. On 17-MAR-2012 the patient experienced swollen macerated lips and oral mucosa and severe conjunctivitis. Patient had seen physician on 20-MAR-2012 and was sent to emergency room. Patient was admitted to hospital for 3 days and diagnosed with Stevens - Johnson syndrome and mycoplasma pneumoniae, a known cause of S-J Syndrome. The following information was obtained through follow-up and/or provided by the government. 4/13/12. Hospital records DOS 3/20-23/2012. Patient was diagnosed with: conjunctivitis, Johnson-Stevens erythema multiforme exudative, mouth pain, cough, eye swelling, conjunctivitis, lip dryness/swelling, watery eyes, injection site redness (resolved prior to administration), mouth pain, ulcerations in mouth, fever, pulmonary embolism, peeling, red, dry cracked lips; conjunctival erythema. Patient was admitted et responded to prescription. The patient was discharged in stable condition. Positive mycoplasma titres were performed. The following information was obtained through follow-up and/or provided by the government. 4/13/12: Mycoplasma Ab IgM 3.33 u/l (H), ESR 110 mm/hr (H), CRP 4.3 mg/dl (H), WBC 19 K/mm3 (H), neuts 85% (H), lymphs 7% (l), pit 435 K/mm3 (H), T prot 8.4 g/dl (H) and CXR with a result of RUI infiltrate & possible associated R hilar lymphadenopathy. There was illness at the time of vaccination: cough, which was later confirmed to be mycoplasma pneumoniae. The following information was obtained through follow-up and/or provided by the government on 4/13/12 Hospital records, coughing; URI. No further information is available.
Age: 13.0
Sex: F
Vaccine: HPV4, HPV4
Symptoms: Conjunctival hyperaemia, Conjunctivitis, Cough, Erythema multiforme, Eye swelling
Clinical narrative: This report was identified from a line listing obtained on request by the Company from the FDA under the Freedom of Information Act. A 13 years old female patient was vaccinated IM on the left arm with the first dose of GARDASIL (lot# 0121AE) on 15-MAR-2012. No other co-suspects were reported. No concomitant medications were reported. On 17-MAR-2012 the patient experienced swollen macerated lips and oral mucosa and severe conjunctivitis. Patient had seen physician on 20-MAR-2012 and was sent to emergency room. Patient was admitted to hospital for 3 days and diagnosed with Stevens - Johnson syndrome and mycoplasma pneumoniae, a known cause of S-J Syndrome. The following information was obtained through follow-up and/or provided by the government. 4/13/12. Hospital records DOS 3/20-23/2012. Patient was diagnosed with: conjunctivitis, Johnson-Stevens erythema multiforme exudative, mouth pain, cough, eye swelling, conjunctivitis, lip dryness/swelling, watery eyes, injection site redness (resolved prior to administration), mouth pain, ulcerations in mouth, fever, pulmonary embolism, peeling, red, dry cracked lips; conjunctival erythema. Patient was admitted et responded to prescription. The patient was discharged in stable condition. Positive mycoplasma titres were performed. The following information was obtained through follow-up and/or provided by the government. 4/13/12: Mycoplasma Ab IgM 3.33 u/l (H), ESR 110 mm/hr (H), CRP 4.3 mg/dl (H), WBC 19 K/mm3 (H), neuts 85% (H), lymphs 7% (l), pit 435 K/mm3 (H), T prot 8.4 g/dl (H) and CXR with a result of RUI infiltrate & possible associated R hilar lymphadenopathy. There was illness at the time of vaccination: cough, which was later confirmed to be mycoplasma pneumoniae. The following information was obtained through follow-up and/or provided by the government on 4/13/12 Hospital records, coughing; URI. No further information is available.
Age: 13.0
Sex: F
Vaccine: HPV4, HPV4
Symptoms: Hilar lymphadenopathy, Injection site erythema, Lacrimation increased, Lip dry, Lip exfoliation
Clinical narrative: This report was identified from a line listing obtained on request by the Company from the FDA under the Freedom of Information Act. A 13 years old female patient was vaccinated IM on the left arm with the first dose of GARDASIL (lot# 0121AE) on 15-MAR-2012. No other co-suspects were reported. No concomitant medications were reported. On 17-MAR-2012 the patient experienced swollen macerated lips and oral mucosa and severe conjunctivitis. Patient had seen physician on 20-MAR-2012 and was sent to emergency room. Patient was admitted to hospital for 3 days and diagnosed with Stevens - Johnson syndrome and mycoplasma pneumoniae, a known cause of S-J Syndrome. The following information was obtained through follow-up and/or provided by the government. 4/13/12. Hospital records DOS 3/20-23/2012. Patient was diagnosed with: conjunctivitis, Johnson-Stevens erythema multiforme exudative, mouth pain, cough, eye swelling, conjunctivitis, lip dryness/swelling, watery eyes, injection site redness (resolved prior to administration), mouth pain, ulcerations in mouth, fever, pulmonary embolism, peeling, red, dry cracked lips; conjunctival erythema. Patient was admitted et responded to prescription. The patient was discharged in stable condition. Positive mycoplasma titres were performed. The following information was obtained through follow-up and/or provided by the government. 4/13/12: Mycoplasma Ab IgM 3.33 u/l (H), ESR 110 mm/hr (H), CRP 4.3 mg/dl (H), WBC 19 K/mm3 (H), neuts 85% (H), lymphs 7% (l), pit 435 K/mm3 (H), T prot 8.4 g/dl (H) and CXR with a result of RUI infiltrate & possible associated R hilar lymphadenopathy. There was illness at the time of vaccination: cough, which was later confirmed to be mycoplasma pneumoniae. The following information was obtained through follow-up and/or provided by the government on 4/13/12 Hospital records, coughing; URI. No further information is available.
Age: 13.0
Sex: F
Vaccine: HPV4, HPV4
Symptoms: Lip swelling, Lung infiltration, Lymphocyte percentage decreased, Mouth ulceration, Mycoplasma test positive
Clinical narrative: This report was identified from a line listing obtained on request by the Company from the FDA under the Freedom of Information Act. A 13 years old female patient was vaccinated IM on the left arm with the first dose of GARDASIL (lot# 0121AE) on 15-MAR-2012. No other co-suspects were reported. No concomitant medications were reported. On 17-MAR-2012 the patient experienced swollen macerated lips and oral mucosa and severe conjunctivitis. Patient had seen physician on 20-MAR-2012 and was sent to emergency room. Patient was admitted to hospital for 3 days and diagnosed with Stevens - Johnson syndrome and mycoplasma pneumoniae, a known cause of S-J Syndrome. The following information was obtained through follow-up and/or provided by the government. 4/13/12. Hospital records DOS 3/20-23/2012. Patient was diagnosed with: conjunctivitis, Johnson-Stevens erythema multiforme exudative, mouth pain, cough, eye swelling, conjunctivitis, lip dryness/swelling, watery eyes, injection site redness (resolved prior to administration), mouth pain, ulcerations in mouth, fever, pulmonary embolism, peeling, red, dry cracked lips; conjunctival erythema. Patient was admitted et responded to prescription. The patient was discharged in stable condition. Positive mycoplasma titres were performed. The following information was obtained through follow-up and/or provided by the government. 4/13/12: Mycoplasma Ab IgM 3.33 u/l (H), ESR 110 mm/hr (H), CRP 4.3 mg/dl (H), WBC 19 K/mm3 (H), neuts 85% (H), lymphs 7% (l), pit 435 K/mm3 (H), T prot 8.4 g/dl (H) and CXR with a result of RUI infiltrate & possible associated R hilar lymphadenopathy. There was illness at the time of vaccination: cough, which was later confirmed to be mycoplasma pneumoniae. The following information was obtained through follow-up and/or provided by the government on 4/13/12 Hospital records, coughing; URI. No further information is available.
Age: 13.0
Sex: F
Vaccine: HPV4, HPV4
Symptoms: Neutrophil percentage increased, Oedema mouth, Oral pain, Platelet count increased, Pneumonia mycoplasmal
Clinical narrative: This report was identified from a line listing obtained on request by the Company from the FDA under the Freedom of Information Act. A 13 years old female patient was vaccinated IM on the left arm with the first dose of GARDASIL (lot# 0121AE) on 15-MAR-2012. No other co-suspects were reported. No concomitant medications were reported. On 17-MAR-2012 the patient experienced swollen macerated lips and oral mucosa and severe conjunctivitis. Patient had seen physician on 20-MAR-2012 and was sent to emergency room. Patient was admitted to hospital for 3 days and diagnosed with Stevens - Johnson syndrome and mycoplasma pneumoniae, a known cause of S-J Syndrome. The following information was obtained through follow-up and/or provided by the government. 4/13/12. Hospital records DOS 3/20-23/2012. Patient was diagnosed with: conjunctivitis, Johnson-Stevens erythema multiforme exudative, mouth pain, cough, eye swelling, conjunctivitis, lip dryness/swelling, watery eyes, injection site redness (resolved prior to administration), mouth pain, ulcerations in mouth, fever, pulmonary embolism, peeling, red, dry cracked lips; conjunctival erythema. Patient was admitted et responded to prescription. The patient was discharged in stable condition. Positive mycoplasma titres were performed. The following information was obtained through follow-up and/or provided by the government. 4/13/12: Mycoplasma Ab IgM 3.33 u/l (H), ESR 110 mm/hr (H), CRP 4.3 mg/dl (H), WBC 19 K/mm3 (H), neuts 85% (H), lymphs 7% (l), pit 435 K/mm3 (H), T prot 8.4 g/dl (H) and CXR with a result of RUI infiltrate & possible associated R hilar lymphadenopathy. There was illness at the time of vaccination: cough, which was later confirmed to be mycoplasma pneumoniae. The following information was obtained through follow-up and/or provided by the government on 4/13/12 Hospital records, coughing; URI. No further information is available.
Age: 13.0
Sex: F
Vaccine: HPV4, HPV4
Symptoms: Protein total increased, Pulmonary embolism, Pyrexia, Red blood cell sedimentation rate increased, Skin maceration
Clinical narrative: This report was identified from a line listing obtained on request by the Company from the FDA under the Freedom of Information Act. A 13 years old female patient was vaccinated IM on the left arm with the first dose of GARDASIL (lot# 0121AE) on 15-MAR-2012. No other co-suspects were reported. No concomitant medications were reported. On 17-MAR-2012 the patient experienced swollen macerated lips and oral mucosa and severe conjunctivitis. Patient had seen physician on 20-MAR-2012 and was sent to emergency room. Patient was admitted to hospital for 3 days and diagnosed with Stevens - Johnson syndrome and mycoplasma pneumoniae, a known cause of S-J Syndrome. The following information was obtained through follow-up and/or provided by the government. 4/13/12. Hospital records DOS 3/20-23/2012. Patient was diagnosed with: conjunctivitis, Johnson-Stevens erythema multiforme exudative, mouth pain, cough, eye swelling, conjunctivitis, lip dryness/swelling, watery eyes, injection site redness (resolved prior to administration), mouth pain, ulcerations in mouth, fever, pulmonary embolism, peeling, red, dry cracked lips; conjunctival erythema. Patient was admitted et responded to prescription. The patient was discharged in stable condition. Positive mycoplasma titres were performed. The following information was obtained through follow-up and/or provided by the government. 4/13/12: Mycoplasma Ab IgM 3.33 u/l (H), ESR 110 mm/hr (H), CRP 4.3 mg/dl (H), WBC 19 K/mm3 (H), neuts 85% (H), lymphs 7% (l), pit 435 K/mm3 (H), T prot 8.4 g/dl (H) and CXR with a result of RUI infiltrate & possible associated R hilar lymphadenopathy. There was illness at the time of vaccination: cough, which was later confirmed to be mycoplasma pneumoniae. The following information was obtained through follow-up and/or provided by the government on 4/13/12 Hospital records, coughing; URI. No further information is available.
Age: 13.0
Sex: F
Vaccine: HPV4, HPV4
Symptoms: Stevens-Johnson syndrome, White blood cell count increased
Clinical narrative: This report was identified from a line listing obtained on request by the Company from the FDA under the Freedom of Information Act. A 13 years old female patient was vaccinated IM on the left arm with the first dose of GARDASIL (lot# 0121AE) on 15-MAR-2012. No other co-suspects were reported. No concomitant medications were reported. On 17-MAR-2012 the patient experienced swollen macerated lips and oral mucosa and severe conjunctivitis. Patient had seen physician on 20-MAR-2012 and was sent to emergency room. Patient was admitted to hospital for 3 days and diagnosed with Stevens - Johnson syndrome and mycoplasma pneumoniae, a known cause of S-J Syndrome. The following information was obtained through follow-up and/or provided by the government. 4/13/12. Hospital records DOS 3/20-23/2012. Patient was diagnosed with: conjunctivitis, Johnson-Stevens erythema multiforme exudative, mouth pain, cough, eye swelling, conjunctivitis, lip dryness/swelling, watery eyes, injection site redness (resolved prior to administration), mouth pain, ulcerations in mouth, fever, pulmonary embolism, peeling, red, dry cracked lips; conjunctival erythema. Patient was admitted et responded to prescription. The patient was discharged in stable condition. Positive mycoplasma titres were performed. The following information was obtained through follow-up and/or provided by the government. 4/13/12: Mycoplasma Ab IgM 3.33 u/l (H), ESR 110 mm/hr (H), CRP 4.3 mg/dl (H), WBC 19 K/mm3 (H), neuts 85% (H), lymphs 7% (l), pit 435 K/mm3 (H), T prot 8.4 g/dl (H) and CXR with a result of RUI infiltrate & possible associated R hilar lymphadenopathy. There was illness at the time of vaccination: cough, which was later confirmed to be mycoplasma pneumoniae. The following information was obtained through follow-up and/or provided by the government on 4/13/12 Hospital records, coughing; URI. No further information is available.
Age: 16.0
Sex: F
Vaccine: HPV4, HPV4
Symptoms: Hypoaesthesia, Pain in extremity, Paraesthesia
Clinical narrative: This report was identified from a line listing obtained on request by the Company from the FDA under the Freedom of Information Act refers to a 16 years old female patient. The patient was vaccinated IM on the left arm with the second dose of GARDASIL (lot # 668051/1262AA) on 16-MAR-2012. At the time of vaccination, the patient had allergic rhinitis. No other co-suspects were reported. No concomitant medications were reported. On 16-MAR-2012 the patient experienced left arm pain with intermittent numbness and tingling for at least one week after injection. The patient was given ibuprofen 600 mg twice a day with food for two weeks, ice. The original reporting source was not provided. Additional information is not expected.
Age: 13.0
Sex: M
Vaccine: HPV4, HPV4
Symptoms: Dizziness, Presyncope
Clinical narrative: This report was identified from a line listing obtained on request by the Company from the FDA under the Freedom of Information Act. This spontaneous report as received from a regulatory authority refers to a 13 years old male patient. The patient was vaccinated with dose 1 GARDASIL on 13-APR-2012, (lot # 1359AA). No other co-suspects were reported. No concomitant medications were reported. On 13-APR-2012 the patient experienced dizziness, 1 day after onset of therapy and presyncope. No treatment information was reported. The outcome of dizziness and presyncope is unknown. The relatedness for dizziness and presyncope is unknown for GARDASIL. Additional information is not expected.
Age: 11.0
Sex: M
Vaccine: HEPA, HPV4, HEPA, HPV4
Symptoms: Dizziness, Feeling cold, Hyperhidrosis, Syncope
Clinical narrative: This report was identified from a line listing obtained on request by the Company from the FDA under the Freedom of Information Act. An 11 years old male patient with no medical history and no illness at vaccination was vaccinated IM with lot # (670048/0963AA) dose 2 GARDASIL (dose not reported) into her right arm on 07-APR-2012. Concomitant medications included: the second dose of HAVRIX (lot#AHAVB539CA) IM into her left arm. On 07-APR-2012 the patient had brief fainting spell 15 minutes after administration, cold and sweaty, dizziness and lightheaded. Patient recovered after 40 minutes. No ER visit was required. The reporter considered the events as not serious. The original reporting source was not provided. The VAERS ID# is 453893. No further information is available.
Age: 10.0
Sex: M
Vaccine: HPV4, MNQ, TDAP, VARCEL, HPV4, MNQ, TDAP, VARCEL
Symptoms: Erythema, Skin warm, Swelling
Clinical narrative: This report was identified from a line listing obtained on request by the Company from the FDA under the Freedom of Information Act. A 10 years old male patient with insomnia NOS; Sinusitis, attention deficit w/o hyperactivity; Cleft palate, unspecified, Anxiety state NOS and a history of acute NEC; Diarrhea; Infantile cerebral palsy, unspecified; Unspecified delay in development; Pierre robin syndrome; Hypotony of eye, unspecified; other extrapyramidal disease and abnormal movement disorders, Conditions due to anomaly of unspecified chromosome and no previous illness who on 10-APR-2012 was vaccinated into the left leg with first dose of GARDASIL (MSD, lot# 671994/1537AA, route unknown). Other suspected therapy included VARIVAX (Merck) (MSD) vaccinated into the left leg (lot# 670858/0979AA, route unknown) on 10-APR-2012. Concomitant therapy included BOOSTRIX (manufacturer: GlaxoSmithKline, lot # AC52B071BB, right leg on 10-APR-2012) and MENACTRA (manufacturer: Sanofi Pasteur, lot # U4030AA, right leg on 10-APR-2012), METHYLIN, BACTROBAN, amoxicillin and clonidine hydrochloride. On 11-APR-2012 the patient experienced Redness/swelling and warm to the touch 1 day after vaccine. No lab data provided. No conditions. At the time of the report, the patient's outcome was unknown. The original reporting source was not provided. The VAERS ID # is 453936.
Age: 14.0
Sex: F
Vaccine: HPV4, HPV4
Symptoms: Blood test, Dizziness, Electroencephalogram normal, Headache, Muscle spasms
Clinical narrative: This report was identified from a line listing obtained on request by the Company from the FDA under the Freedom of Information Act. A 14 years old female patient with no medical history and no previous illness was vaccinated IM into the left arm with first dose of GARDASIL (lot# unspecified, route unknown) on 04-APR-2012. Concomitant therapy included ZOLOFT and ATIVAN. On 04-APR-2012 the patient experienced blurred vision, seizure like, muscle spasms, headache and dizziness. Patient had two doctor visits, two ER visits. EEG (Electroencephalogram) was done 18-APR-2012 but negative results. Many blood test, and neurology consult were performed. At time of the report, the patient's outcome was unknown. The original reporting source was not provided. The VAERS ID # is 453975.
Age: 14.0
Sex: F
Vaccine: HPV4, HPV4
Symptoms: Seizure like phenomena, Vision blurred
Clinical narrative: This report was identified from a line listing obtained on request by the Company from the FDA under the Freedom of Information Act. A 14 years old female patient with no medical history and no previous illness was vaccinated IM into the left arm with first dose of GARDASIL (lot# unspecified, route unknown) on 04-APR-2012. Concomitant therapy included ZOLOFT and ATIVAN. On 04-APR-2012 the patient experienced blurred vision, seizure like, muscle spasms, headache and dizziness. Patient had two doctor visits, two ER visits. EEG (Electroencephalogram) was done 18-APR-2012 but negative results. Many blood test, and neurology consult were performed. At time of the report, the patient's outcome was unknown. The original reporting source was not provided. The VAERS ID # is 453975.
Age: 16.0
Sex: F
Vaccine: HPV4, HPV4
Symptoms: Dyspnoea, Pallor, Pruritus, Rash generalised, Tachycardia
Clinical narrative: This report was identified from a line listing obtained on request by the Company from the FDA under the Freedom of Information Act refers to a 16 years old female patient with asthma. The patient was vaccinated IM on right arm with the second dose of GARDASIL (lot # 669795/1317AA, EXP Date 13-OCT-2013) on 19-APR-2012. No other co-suspects were reported. Concomitant medications included SINGULAIR, VENTOLIN HFA and DEPO-PROVERA. Previous vaccine included unknown pertussis vaccine (no brand name). Shortly after receiving GARDASIL vaccine on 19-APR-2012 the patient developed a rash described by parent as diffused with hives, difficulty breathing. Patient was given BENADRYL 50 mg at home. Patient had seen at the ER at 6:30pm- no hives present, itching, pallor, tachycardia. Patient had been given SOLUMEDROL, improved and sent home. The original reporting source was not provided. Additional information is not expected.
Age: 16.0
Sex: F
Vaccine: HPV4, HPV4
Symptoms: Urticaria
Clinical narrative: This report was identified from a line listing obtained on request by the Company from the FDA under the Freedom of Information Act refers to a 16 years old female patient with asthma. The patient was vaccinated IM on right arm with the second dose of GARDASIL (lot # 669795/1317AA, EXP Date 13-OCT-2013) on 19-APR-2012. No other co-suspects were reported. Concomitant medications included SINGULAIR, VENTOLIN HFA and DEPO-PROVERA. Previous vaccine included unknown pertussis vaccine (no brand name). Shortly after receiving GARDASIL vaccine on 19-APR-2012 the patient developed a rash described by parent as diffused with hives, difficulty breathing. Patient was given BENADRYL 50 mg at home. Patient had seen at the ER at 6:30pm- no hives present, itching, pallor, tachycardia. Patient had been given SOLUMEDROL, improved and sent home. The original reporting source was not provided. Additional information is not expected.
Age: 16.0
Sex: F
Vaccine: HPV4, HPV4
Symptoms: Dyspnoea, Pallor, Pruritus, Rash, Tachycardia
Clinical narrative: This report was identified from a line listing obtained on request by the Company from the FDA under the Freedom of Information Act refers to a 16 years old female patient with asthma. The patient was vaccinated IM on right arm with the second dose of GARDASIL (lot # 669795/1317AA, EXP Date 13-OCT-2013) on 19-APR-2012. No other co-suspects were reported. Concomitant medications included SINGULAIR, VENTOLIN HFA and DEPO-PROVERA. Previous vaccine included unknown pertussis vaccine (no brand name). Shortly after receiving GARDASIL vaccine on 19-APR-2012 the patient developed a rash described by parent as diffused with hives, difficulty breathing. Patient was given BENADRYL 50 mg at home. Patient had seen at the ER at 6:30pm- no hives present, itching, pallor, tachycardia. Patient had been given SOLUMEDROL, improved and sent home. The original reporting source was not provided. Additional information is not expected.
Age: 11.0
Sex: M
Vaccine: HPV4, MNQ, TDAP, HPV4, MNQ, TDAP
Symptoms: Arthropathy, Headache, Injected limb mobility decreased, Injection site nodule, Muscular weakness
Clinical narrative: This report was obtained on request by the Company from the FDA under the Freedom of Information Act. An 11 years old male patient with no pre-existing illness on 05-MAY-2008, was vaccinated in the right arm with the first dose of GARDASIL (lot# 0002U). Concomitant vaccines given on the same day included the first dose of ADACEL (lot# C2732AA) given in the left arm and the first dose of MENACTRA (lot# U2534AA) given in the left arm. It was reported that on an unspecified date, the patient experienced a knot at injection site lasting over a month. Both upper arms were sore for over a week. His knees were weak and his joints loose. The patient experienced fever and headache that lasted approximately a week. The patient could not lift the injection site arm comfortably for a week. The patient was last seen in office on 05-MAY-2008 for physical examination and 11 year old shots. The patient returned on 08-MAY-2012 for another physical examination at 15 and never called and reported complaint 4 years ago. The outcome of joints loose and knees weak was unknown. The outcome of headache, fever, both upper arms sore, knot an injection site and could not lift injection site arm comfortably was reported as recovered. This report was considered non serious with no conditions by the Agency. The original reporting source was not provided. The VAERS ID# is 455211-1. Additional information is not expected.
Age: 11.0
Sex: M
Vaccine: HPV4, MNQ, TDAP, HPV4, MNQ, TDAP
Symptoms: Pain in extremity, Pyrexia
Clinical narrative: This report was obtained on request by the Company from the FDA under the Freedom of Information Act. An 11 years old male patient with no pre-existing illness on 05-MAY-2008, was vaccinated in the right arm with the first dose of GARDASIL (lot# 0002U). Concomitant vaccines given on the same day included the first dose of ADACEL (lot# C2732AA) given in the left arm and the first dose of MENACTRA (lot# U2534AA) given in the left arm. It was reported that on an unspecified date, the patient experienced a knot at injection site lasting over a month. Both upper arms were sore for over a week. His knees were weak and his joints loose. The patient experienced fever and headache that lasted approximately a week. The patient could not lift the injection site arm comfortably for a week. The patient was last seen in office on 05-MAY-2008 for physical examination and 11 year old shots. The patient returned on 08-MAY-2012 for another physical examination at 15 and never called and reported complaint 4 years ago. The outcome of joints loose and knees weak was unknown. The outcome of headache, fever, both upper arms sore, knot an injection site and could not lift injection site arm comfortably was reported as recovered. This report was considered non serious with no conditions by the Agency. The original reporting source was not provided. The VAERS ID# is 455211-1. Additional information is not expected.
Age: 11.0
Sex: M
Vaccine: HPV4, MNQ, TDAP, HPV4, MNQ, TDAP
Symptoms: Arthropathy, Asthenia, Headache, Injected limb mobility decreased, Injection site nodule
Clinical narrative: This report was obtained on request by the Company from the FDA under the Freedom of Information Act. An 11 years old male patient with no pre-existing illness on 05-MAY-2008, was vaccinated in the right arm with the first dose of GARDASIL (lot# 0002U). Concomitant vaccines given on the same day included the first dose of ADACEL (lot# C2732AA) given in the left arm and the first dose of MENACTRA (lot# U2534AA) given in the left arm. It was reported that on an unspecified date, the patient experienced a knot at injection site lasting over a month. Both upper arms were sore for over a week. His knees were weak and his joints loose. The patient experienced fever and headache that lasted approximately a week. The patient could not lift the injection site arm comfortably for a week. The patient was last seen in office on 05-MAY-2008 for physical examination and 11 year old shots. The patient returned on 08-MAY-2012 for another physical examination at 15 and never called and reported complaint 4 years ago. The outcome of joints loose and knees weak was unknown. The outcome of headache, fever, both upper arms sore, knot an injection site and could not lift injection site arm comfortably was reported as recovered. This report was considered non serious with no conditions by the Agency. The original reporting source was not provided. The VAERS ID# is 455211-1. Additional information is not expected.
Age: 11.0
Sex: M
Vaccine: HPV4, MNQ, TDAP, HPV4, MNQ, TDAP
Symptoms: Injection site pain, Pyrexia
Clinical narrative: This report was obtained on request by the Company from the FDA under the Freedom of Information Act. An 11 years old male patient with no pre-existing illness on 05-MAY-2008, was vaccinated in the right arm with the first dose of GARDASIL (lot# 0002U). Concomitant vaccines given on the same day included the first dose of ADACEL (lot# C2732AA) given in the left arm and the first dose of MENACTRA (lot# U2534AA) given in the left arm. It was reported that on an unspecified date, the patient experienced a knot at injection site lasting over a month. Both upper arms were sore for over a week. His knees were weak and his joints loose. The patient experienced fever and headache that lasted approximately a week. The patient could not lift the injection site arm comfortably for a week. The patient was last seen in office on 05-MAY-2008 for physical examination and 11 year old shots. The patient returned on 08-MAY-2012 for another physical examination at 15 and never called and reported complaint 4 years ago. The outcome of joints loose and knees weak was unknown. The outcome of headache, fever, both upper arms sore, knot an injection site and could not lift injection site arm comfortably was reported as recovered. This report was considered non serious with no conditions by the Agency. The original reporting source was not provided. The VAERS ID# is 455211-1. Additional information is not expected.
Age: 12.0
Sex: F
Vaccine: HPV4, MNQ, TDAP, VARCEL, HPV4, MNQ, TDAP, VARCEL
Symptoms: Injection site haemorrhage
Clinical narrative: This report was identified from a line listing obtained on request by the Company from the FDA under the Freedom of Information Act. At approximately 9:30 AM on 17-MAY-2012, a 12 year old male was vaccinated intramuscularly with a first dose of GARSIL (Lot # 670050/1229AA) in the right arm upper. Suspect therapy given intramuscularly into right arm lower included a first dose of MENACTRA (Lot# U3778AA). Concomitant therapy given included a second dose of VARIVAX (Lot# 671085/0829AA) subcutaneously in left arm lower and a first dose of BOOSTRIX (Lot# AC52B070BA, also reported as ADACEL) intramuscularly into left arm upper. Patient reported on 18-MAY-2012 spontaneous bleeding from MENACTRA injection site. Area did not appear bruised or that he had scratched at in his sleep. His Mom stated "a lot of blood". The original reporting source was not provided. The VAERS ID # is 455807-1. No further information is available.
Age: 17.0
Sex: F
Vaccine: HPV4, HPV4
Symptoms: Gaze palsy, Hallucination, auditory, Musculoskeletal stiffness, Seizure like phenomena
Clinical narrative: This report was identified from a line listing obtained on request by the Company from the FDA under the Freedom of Information Act. A 17 years old female was vaccinated with the first dose of GARDASIL (lot# reported as "1696AA") on 29-MAY-2012 injected into her right arm. The patient had allergic to penicillin and no pre-existing illness. There were no other medications. On 29-MAY-2012, the patient had mild seizure like activity eyes rolled back of head, and her body was stiff. The patient said that she heard music episode lasted about 30 mins. There was no lab data. At the time of reporting, the patient's outcome was not reported. The agency considered the events to be non-serious and no conditions. The original reporting source was provided by a consumer. The VAERS ID # is 456568. No further information is available.
Age: 26.0
Sex: F
Vaccine: HPV4, HPV4
Symptoms: Diarrhoea, Dizziness, Fatigue, Headache, Insomnia
Clinical narrative: This report was identified from a line listing obtained on request by the Company from the FDA under the Freedom of Information Act refers to a 26 years old female patient. The patient's medical history included lymphedema in right leg and left arm. The patient was vaccinated on the right arm with first dose of GARDASIL on 17-APR-2012. No other co-suspects were reported. No concomitant medications were reported. On 20-APR-2112 the patient experienced diarrhoea, swollen glands in both armpits, insomnia, headache, tired and dizziness. The original reporting source was not provided. Additional information is not expected.
Age: 26.0
Sex: F
Vaccine: HPV4, HPV4
Symptoms: Lymphadenopathy
Clinical narrative: This report was identified from a line listing obtained on request by the Company from the FDA under the Freedom of Information Act refers to a 26 years old female patient. The patient's medical history included lymphedema in right leg and left arm. The patient was vaccinated on the right arm with first dose of GARDASIL on 17-APR-2012. No other co-suspects were reported. No concomitant medications were reported. On 20-APR-2112 the patient experienced diarrhoea, swollen glands in both armpits, insomnia, headache, tired and dizziness. The original reporting source was not provided. Additional information is not expected.