chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 0.34
Sex: M
Vaccine: DTAPIPVHIB, PNC13, RV1, DTAPIPVHIB, PNC, RV1, DTAPIPVHIB, PNC13, RV1
Symptoms: Laboratory test normal, Muscle rigidity, Posture abnormal, Staring
Clinical narrative: This case was reported by a healthcare professional and described the occurrence of seizure in a 4-month-old male subject who was vaccinated with ROTARIX lyophilized formulation (GlaxoSmithKline), PENTACEL (non-gsk). Concurrent medical conditions included gastroesophageal reflux disease, spitting up described as "expelling formula" and vomiting. Concurrent vaccination included pneumococcal vaccines (non-gsk); Wyeth Labs; unknown; unknown given on 8 September 2012. The healthcare professional reported that 4 month old subject received routine pediatric vaccines at age 2 and 4 months of age. No adverse events were reported after the first vaccine. On 06 July 2012, the subject started ZANTAC at 22.5 mg (oral) twice daily for gastroesophageal reflux disease. On 8 September 2012 at 09:30 the subject received 2nd dose of ROTARIX lyophilized formulation (1 ml, oral) and on 8 September 2012 the subject received 2nd dose of PENTACEL (details unknown). On 9 September 2012, 24 hours after vaccination with PENTACEL and ROTARIX lyophilized formulation and 65 days after starting ZANTAC, the subject experienced seizure described as, repetitive head turning, refusal to eat, arm rigidity and stared blankly into space. The subject was seen at 4 months for routine vaccination and developed seizures 24 hours after the vaccinations. He was still on ZANTAC at this time as well. The subject was reported to "turn his head to the right repeatedly" (repetitive head turning) and refused to eat. While being changed his right arm became rigid and he "developed a blank stare" (stared blankly into space). The episode lasted for about 20-30 seconds and was repeated a total of four times that morning. The subject was hospitalized for 2 days and there was no evidence of reason for seizures. He was afebrile, WNL [within normal limits] EEG [Electroencephalogram], CT scan [Computerized tomogram], and labwork. Seizures were considered to be secondary to immunization with DTaP vaccine from another manufacturer, PENTACEL. The subject was hospitalised and the healthcare professional considered the events were life threatening. At the time of reporting the events were resolved. The healthcare professional considered the events were unrelated to vaccination with ROTARIX lyophilized formulation and ZANTAC. The healthcare professional considered the events were related to the vaccination with PENTACEL due to the DTaP component of the vaccine.
Age: 0.34
Sex: M
Vaccine: DTAPIPVHIB, PNC13, RV1, DTAPIPVHIB, PNC, RV1, DTAPIPVHIB, PNC13, RV1
Symptoms: Dyskinesia, Electroencephalogram normal, Hypotonia, Irritability, Staring
Clinical narrative: This case was reported by a healthcare professional and described the occurrence of seizure in a 4-month-old male subject who was vaccinated with ROTARIX lyophilized formulation (GlaxoSmithKline), PENTACEL (non-gsk). Concurrent medical conditions included gastroesophageal reflux disease, spitting up described as "expelling formula" and vomiting. Concurrent vaccination included pneumococcal vaccines (non-gsk); Wyeth Labs; unknown; unknown given on 8 September 2012. The healthcare professional reported that 4 month old subject received routine pediatric vaccines at age 2 and 4 months of age. No adverse events were reported after the first vaccine. On 06 July 2012, the subject started ZANTAC at 22.5 mg (oral) twice daily for gastroesophageal reflux disease. On 8 September 2012 at 09:30 the subject received 2nd dose of ROTARIX lyophilized formulation (1 ml, oral) and on 8 September 2012 the subject received 2nd dose of PENTACEL (details unknown). On 9 September 2012, 24 hours after vaccination with PENTACEL and ROTARIX lyophilized formulation and 65 days after starting ZANTAC, the subject experienced seizure described as, repetitive head turning, refusal to eat, arm rigidity and stared blankly into space. The subject was seen at 4 months for routine vaccination and developed seizures 24 hours after the vaccinations. He was still on ZANTAC at this time as well. The subject was reported to "turn his head to the right repeatedly" (repetitive head turning) and refused to eat. While being changed his right arm became rigid and he "developed a blank stare" (stared blankly into space). The episode lasted for about 20-30 seconds and was repeated a total of four times that morning. The subject was hospitalized for 2 days and there was no evidence of reason for seizures. He was afebrile, WNL [within normal limits] EEG [Electroencephalogram], CT scan [Computerized tomogram], and labwork. Seizures were considered to be secondary to immunization with DTaP vaccine from another manufacturer, PENTACEL. The subject was hospitalised and the healthcare professional considered the events were life threatening. At the time of reporting the events were resolved. The healthcare professional considered the events were unrelated to vaccination with ROTARIX lyophilized formulation and ZANTAC. The healthcare professional considered the events were related to the vaccination with PENTACEL due to the DTaP component of the vaccine.
Age: 0.34
Sex: M
Vaccine: DTAPIPVHIB, PNC13, RV1, DTAPIPVHIB, PNC, RV1, DTAPIPVHIB, PNC13, RV1
Symptoms: Tremor
Clinical narrative: This case was reported by a healthcare professional and described the occurrence of seizure in a 4-month-old male subject who was vaccinated with ROTARIX lyophilized formulation (GlaxoSmithKline), PENTACEL (non-gsk). Concurrent medical conditions included gastroesophageal reflux disease, spitting up described as "expelling formula" and vomiting. Concurrent vaccination included pneumococcal vaccines (non-gsk); Wyeth Labs; unknown; unknown given on 8 September 2012. The healthcare professional reported that 4 month old subject received routine pediatric vaccines at age 2 and 4 months of age. No adverse events were reported after the first vaccine. On 06 July 2012, the subject started ZANTAC at 22.5 mg (oral) twice daily for gastroesophageal reflux disease. On 8 September 2012 at 09:30 the subject received 2nd dose of ROTARIX lyophilized formulation (1 ml, oral) and on 8 September 2012 the subject received 2nd dose of PENTACEL (details unknown). On 9 September 2012, 24 hours after vaccination with PENTACEL and ROTARIX lyophilized formulation and 65 days after starting ZANTAC, the subject experienced seizure described as, repetitive head turning, refusal to eat, arm rigidity and stared blankly into space. The subject was seen at 4 months for routine vaccination and developed seizures 24 hours after the vaccinations. He was still on ZANTAC at this time as well. The subject was reported to "turn his head to the right repeatedly" (repetitive head turning) and refused to eat. While being changed his right arm became rigid and he "developed a blank stare" (stared blankly into space). The episode lasted for about 20-30 seconds and was repeated a total of four times that morning. The subject was hospitalized for 2 days and there was no evidence of reason for seizures. He was afebrile, WNL [within normal limits] EEG [Electroencephalogram], CT scan [Computerized tomogram], and labwork. Seizures were considered to be secondary to immunization with DTaP vaccine from another manufacturer, PENTACEL. The subject was hospitalised and the healthcare professional considered the events were life threatening. At the time of reporting the events were resolved. The healthcare professional considered the events were unrelated to vaccination with ROTARIX lyophilized formulation and ZANTAC. The healthcare professional considered the events were related to the vaccination with PENTACEL due to the DTaP component of the vaccine.
Age: 0.34
Sex: M
Vaccine: DTAPIPVHIB, PNC13, RV1, DTAPIPVHIB, PNC, RV1, DTAPIPVHIB, PNC13, RV1
Symptoms: Blood culture negative, Blood electrolytes normal, Blood test normal, Carnitine increased, Complex partial seizures
Clinical narrative: This case was reported by a healthcare professional and described the occurrence of seizure in a 4-month-old male subject who was vaccinated with ROTARIX lyophilized formulation (GlaxoSmithKline), PENTACEL (non-gsk). Concurrent medical conditions included gastroesophageal reflux disease, spitting up described as "expelling formula" and vomiting. Concurrent vaccination included pneumococcal vaccines (non-gsk); Wyeth Labs; unknown; unknown given on 8 September 2012. The healthcare professional reported that 4 month old subject received routine pediatric vaccines at age 2 and 4 months of age. No adverse events were reported after the first vaccine. On 06 July 2012, the subject started ZANTAC at 22.5 mg (oral) twice daily for gastroesophageal reflux disease. On 8 September 2012 at 09:30 the subject received 2nd dose of ROTARIX lyophilized formulation (1 ml, oral) and on 8 September 2012 the subject received 2nd dose of PENTACEL (details unknown). On 9 September 2012, 24 hours after vaccination with PENTACEL and ROTARIX lyophilized formulation and 65 days after starting ZANTAC, the subject experienced seizure described as, repetitive head turning, refusal to eat, arm rigidity and stared blankly into space. The subject was seen at 4 months for routine vaccination and developed seizures 24 hours after the vaccinations. He was still on ZANTAC at this time as well. The subject was reported to "turn his head to the right repeatedly" (repetitive head turning) and refused to eat. While being changed his right arm became rigid and he "developed a blank stare" (stared blankly into space). The episode lasted for about 20-30 seconds and was repeated a total of four times that morning. The subject was hospitalized for 2 days and there was no evidence of reason for seizures. He was afebrile, WNL [within normal limits] EEG [Electroencephalogram], CT scan [Computerized tomogram], and labwork. Seizures were considered to be secondary to immunization with DTaP vaccine from another manufacturer, PENTACEL. The subject was hospitalised and the healthcare professional considered the events were life threatening. At the time of reporting the events were resolved. The healthcare professional considered the events were unrelated to vaccination with ROTARIX lyophilized formulation and ZANTAC. The healthcare professional considered the events were related to the vaccination with PENTACEL due to the DTaP component of the vaccine.
Age: 0.34
Sex: M
Vaccine: DTAPIPVHIB, PNC13, RV1, DTAPIPVHIB, PNC, RV1, DTAPIPVHIB, PNC13, RV1
Symptoms: Computerised tomogram normal, Convulsion, Diet refusal, Electroencephalogram normal, Loss of consciousness
Clinical narrative: This case was reported by a healthcare professional and described the occurrence of seizure in a 4-month-old male subject who was vaccinated with ROTARIX lyophilized formulation (GlaxoSmithKline), PENTACEL (non-gsk). Concurrent medical conditions included gastroesophageal reflux disease, spitting up described as "expelling formula" and vomiting. Concurrent vaccination included pneumococcal vaccines (non-gsk); Wyeth Labs; unknown; unknown given on 8 September 2012. The healthcare professional reported that 4 month old subject received routine pediatric vaccines at age 2 and 4 months of age. No adverse events were reported after the first vaccine. On 06 July 2012, the subject started ZANTAC at 22.5 mg (oral) twice daily for gastroesophageal reflux disease. On 8 September 2012 at 09:30 the subject received 2nd dose of ROTARIX lyophilized formulation (1 ml, oral) and on 8 September 2012 the subject received 2nd dose of PENTACEL (details unknown). On 9 September 2012, 24 hours after vaccination with PENTACEL and ROTARIX lyophilized formulation and 65 days after starting ZANTAC, the subject experienced seizure described as, repetitive head turning, refusal to eat, arm rigidity and stared blankly into space. The subject was seen at 4 months for routine vaccination and developed seizures 24 hours after the vaccinations. He was still on ZANTAC at this time as well. The subject was reported to "turn his head to the right repeatedly" (repetitive head turning) and refused to eat. While being changed his right arm became rigid and he "developed a blank stare" (stared blankly into space). The episode lasted for about 20-30 seconds and was repeated a total of four times that morning. The subject was hospitalized for 2 days and there was no evidence of reason for seizures. He was afebrile, WNL [within normal limits] EEG [Electroencephalogram], CT scan [Computerized tomogram], and labwork. Seizures were considered to be secondary to immunization with DTaP vaccine from another manufacturer, PENTACEL. The subject was hospitalised and the healthcare professional considered the events were life threatening. At the time of reporting the events were resolved. The healthcare professional considered the events were unrelated to vaccination with ROTARIX lyophilized formulation and ZANTAC. The healthcare professional considered the events were related to the vaccination with PENTACEL due to the DTaP component of the vaccine.
Age: 0.34
Sex: M
Vaccine: DTAPIPVHIB, PNC13, RV1, DTAPIPVHIB, PNC, RV1, DTAPIPVHIB, PNC13, RV1
Symptoms: Metabolic function test abnormal, Muscle rigidity, Nuclear magnetic resonance imaging normal, Staring, Stereotypy
Clinical narrative: This case was reported by a healthcare professional and described the occurrence of seizure in a 4-month-old male subject who was vaccinated with ROTARIX lyophilized formulation (GlaxoSmithKline), PENTACEL (non-gsk). Concurrent medical conditions included gastroesophageal reflux disease, spitting up described as "expelling formula" and vomiting. Concurrent vaccination included pneumococcal vaccines (non-gsk); Wyeth Labs; unknown; unknown given on 8 September 2012. The healthcare professional reported that 4 month old subject received routine pediatric vaccines at age 2 and 4 months of age. No adverse events were reported after the first vaccine. On 06 July 2012, the subject started ZANTAC at 22.5 mg (oral) twice daily for gastroesophageal reflux disease. On 8 September 2012 at 09:30 the subject received 2nd dose of ROTARIX lyophilized formulation (1 ml, oral) and on 8 September 2012 the subject received 2nd dose of PENTACEL (details unknown). On 9 September 2012, 24 hours after vaccination with PENTACEL and ROTARIX lyophilized formulation and 65 days after starting ZANTAC, the subject experienced seizure described as, repetitive head turning, refusal to eat, arm rigidity and stared blankly into space. The subject was seen at 4 months for routine vaccination and developed seizures 24 hours after the vaccinations. He was still on ZANTAC at this time as well. The subject was reported to "turn his head to the right repeatedly" (repetitive head turning) and refused to eat. While being changed his right arm became rigid and he "developed a blank stare" (stared blankly into space). The episode lasted for about 20-30 seconds and was repeated a total of four times that morning. The subject was hospitalized for 2 days and there was no evidence of reason for seizures. He was afebrile, WNL [within normal limits] EEG [Electroencephalogram], CT scan [Computerized tomogram], and labwork. Seizures were considered to be secondary to immunization with DTaP vaccine from another manufacturer, PENTACEL. The subject was hospitalised and the healthcare professional considered the events were life threatening. At the time of reporting the events were resolved. The healthcare professional considered the events were unrelated to vaccination with ROTARIX lyophilized formulation and ZANTAC. The healthcare professional considered the events were related to the vaccination with PENTACEL due to the DTaP component of the vaccine.
Age: 49.0
Sex: F
Vaccine: FLU3
Symptoms: Unevaluable event
Clinical narrative: None stated.
Age: 23.0
Sex: F
Vaccine: HPV4
Symptoms: Asthenia, Blood pressure decreased
Clinical narrative: This spontaneous report as received from a licensed practical nurse refers to a 23 years old female patient. The patient was vaccinated with dose 1 of GARDASIL (lot #, dose and route not reported) on an unspecified date and was vaccinated intramuscularly with a second 0.5 ml dose of GARDASIL (lot # not provided) last week (approximately on 05-SEP-2012). No other co-suspects were reported. No concomitant medications were reported. The nurse reported that the patient experienced reactions after both her 1st shot and 2nd shot of GARDASIL. After the first dose, the patient experienced a drop in blood pressure and fainted. She was weak and had slurred speech. She recovered in 30 minutes. The patient received the second dose and again experienced a drop in blood pressure and felt weak last week (approximately on 05-SEP-2012). The patient was seen in an urgent care office. No treatment was given for the events. The vaccine series was discontinued. It was reported that drop in blood pressure and felt weak was (after second dose) had improved after therapy was stopped. The relatedness for the reported events was not provided for GARDASIL. Additional information has been requested.
Age: 65.0
Sex: F
Vaccine: PPV
Symptoms: Chills, Injection site pain, Pyrexia, Tremor
Clinical narrative: Reported fever of 100.7, chills & shaking pain at site.
Age: 96.0
Sex: F
Vaccine: FLU3, PPV
Symptoms: Injection site erythema, Injection site swelling, Injection site warmth
Clinical narrative: PNEUMOVAX injection site reaction swelling, redness, warmth.
Age: 60.0
Sex: F
Vaccine: FLU3
Symptoms: Injection site erythema, Injection site induration, Injection site pain, Injection site swelling
Clinical narrative: 9-13-12. Pt received flu vaccine (lt) arm & afterwards received 5 cm across/4 cm down red, indurated area that's tender to touch. Red area goes out & circulates area where injection given which is below deltoid area. 9-17-12. Pt notified to check on area same size: red, less swelling. Pt will call on Wed with update.
Age: 85.0
Sex: M
Vaccine: FLU3, PPV
Symptoms: Injection site erythema, Injection site swelling, Injection site warmth
Clinical narrative: Injection site swelling, redness, warmth.
Age: 65.0
Sex: F
Vaccine: FLU3, PPV
Symptoms: Injection site erythema, Injection site swelling, Injection site warmth
Clinical narrative: PNEUMOVAX injection site reaction swelling, redness down arm warmth.
Age: 93.0
Sex: M
Vaccine: FLU3, PPV
Symptoms: Injection site reaction
Clinical narrative: PNEUMOVAX injection site reaction.
Sex: U
Vaccine: MNQ
Symptoms: Feeling hot, Induration, Local reaction, Tenderness
Clinical narrative: 09/05, local reaction, 09/06 local reaction (1.2/4") 09/06 local reaction 2 1/2" x 2 1/2" with tender, hard & hot.
Age: 35.0
Sex: F
Vaccine: FLU3, FLU3
Symptoms: Dizziness, Rash
Clinical narrative: Patient walked out to waiting room and complained of feeling dizzy. Rash noted on cheeks, chest and abdomen. Patient was helped to exam room where patient was laid down. BP-94/52, P-62, Diphenhydramine 50mg. given IM. Rash subsided. Patient given po fluids. BP-98/57, P-69. Patient sitting 15 min later BP-108/60, P-69. Vitals monitored prior to discharge BP-113/60, P-68.
Age: 35.0
Sex: F
Vaccine: FLU3, FLU3
Symptoms: Dizziness, Heart rate decreased, Hypotension, Rash
Clinical narrative: Patient walked out to waiting room and complained of feeling dizzy. Rash noted on cheeks, chest and abdomen. Patient was helped to exam room where patient was laid down. BP-94/52, P-62, Diphenhydramine 50mg. given IM. Rash subsided. Patient given po fluids. BP-98/57, P-69. Patient sitting 15 min later BP-108/60, P-69. Vitals monitored prior to discharge BP-113/60, P-68.
Age: 0.5
Sex: F
Vaccine: DTAPIPVHIB
Symptoms: Expired drug administered
Clinical narrative: Physician administered vaccine loaded by staff at the facility which outdated.
Age: 28.0
Sex: M
Vaccine: ANTH, SMALL, TYP
Symptoms: Rash generalised, Rash maculo-papular, Respiratory disorder
Clinical narrative: Respiratory issues, generalized maculopapular rash.
Age: 16.0
Sex: F
Vaccine: FLU3, HPV4
Symptoms: Vaccination site erythema, Vaccination site swelling
Clinical narrative: Patient had erythema & swelling at vaccine site which improved after 15 min and after administration of 25 mg BENADRYL.
Age: 49.0
Sex: F
Vaccine: FLU3
Symptoms: Asthenia, Blood creatine phosphokinase increased, Body temperature increased, Dermatomyositis, Platelet count decreased
Clinical narrative: After flu shot had weakness & temperature. Diagnosed 6 weeks later with dermatomyositis.
Age: 58.0
Sex: F
Vaccine: FLU3, PPV
Symptoms: Injection site haematoma, Pain, Swelling
Clinical narrative: Bruising at site of injection, right arm. Swelling in a 3 square inch area under site. Patient taking ibuprofen and applied ice pack. Patient said pain improved since last night, but present.
Age: 22.0
Sex: F
Vaccine: TDAP
Symptoms: Hypoaesthesia, Neck pain, Pruritus, Vertigo
Clinical narrative: Numb (like fell asleep) in Rt leg and both arms. Repeated vertigo & sharp pain in neck. Itchy left palm.
Age: 77.0
Sex: M
Vaccine: FLU3
Symptoms: Dizziness, Fall
Clinical narrative: Customer received flu shot without incident. Shortly thereafter, he fell in one of the aisles. He stated he felt dizzy. He was taken to local hospital for observation.
Age: 73.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site cellulitis, Injection site exfoliation
Clinical narrative: Cellulitis - area at injection is 1" & deep skin loss - whole area of approx. 5" is losing skin. Pt prescribed prednisone & AUGMENTIN for treatment.
Age: 32.0
Sex: M
Vaccine: FLU3, TDAP
Symptoms: Influenza, Pain
Clinical narrative: Normal tightness and mild soreness by next morning. Friday (9-7-12) showed signs and symptoms of nerve damage? pain worsened. Recovered using hot compresses and menthol ointment, mild flu symptoms.
Age: 4.0
Sex: F
Vaccine: DTAP, FLUN3, IPV, MMR, VARCEL
Symptoms: Injection site swelling
Clinical narrative: Administered IPV and Varicella vaccinations - SQ right arm site. Noted swelling at injection site. Presented in the office w/ ice pack applied at site.
Age: 70.0
Sex: F
Vaccine: PPV
Symptoms: Erythema, Urticaria
Clinical narrative: Erythema approx 8 inches in diameter raised (hive).
Age: 4.0
Sex: M
Vaccine: DTAPIPV
Symptoms: Injection site erythema, Injection site swelling, Injection site warmth
Clinical narrative: Left arm is red, swollen about the size of a baseball, and hot.
Age: 27.0
Sex: F
Vaccine: FLU3
Symptoms: Erythema, Maternal exposure during pregnancy, Swelling
Clinical narrative: Patient called pharmacy & reported redness & swelling on left arm - described by pt to be approximately the size of a tennis ball. I recommended putting ice on the area & also contacted pt's doctor. Dr wants pt to contact her in a day or two if it does not get better. I called pt back to relay this information. I attempted to contact pt in the evening of 9/12/12 & 9/13/12 as a follow up. Left message both times.
Age: 0.45
Sex: M
Vaccine: HIBV
Symptoms: Injection site erythema, Injection site induration
Clinical narrative: 1 cm indurated erythematous area (L) thigh - anterior.
Age: 66.0
Sex: F
Vaccine: FLU3, PPV
Symptoms: Injection site erythema, Injection site inflammation, Injection site warmth, Pruritus, Rash
Clinical narrative: Red inflamed skin from shoulder down to elbow on left arm warm to touch. Slight rash under skin extreme itching.
Age: 71.0
Sex: F
Vaccine: VARZOS
Symptoms: Chills, Condition aggravated, Drug ineffective, Nervousness, Parkinson's disease
Clinical narrative: Within 3 days of receiving vaccine, noticed more nervousness, shakiness, internal tremors, teeth chattering. Since vaccine noticed more Parkinson symptoms, medication less effective. Is now taking more Parkinson medications.
Age: 71.0
Sex: F
Vaccine: VARZOS
Symptoms: Tremor
Clinical narrative: Within 3 days of receiving vaccine, noticed more nervousness, shakiness, internal tremors, teeth chattering. Since vaccine noticed more Parkinson symptoms, medication less effective. Is now taking more Parkinson medications.
Age: 6.0
Sex: M
Vaccine: FLU3
Symptoms: Injection site pain, Injection site swelling
Clinical narrative: Parent brought child to hospital c/o soreness and swelling to shot (Flu) site, approx 2 1/2 hrs post immunization. Site with 2 inches size in diameter according to mom. No other symptoms. ER Dr ordered BENADRYL.
Age: 45.0
Sex: M
Vaccine: FLU3, PPV
Symptoms: Hypotension, Nausea, Pyrexia, Vomiting
Clinical narrative: Pt experienced severe rxns. Fever, hypotension, nausea & vomiting. Went to urgent care then office visit. Was out for 3 days.
Age: 1.5
Sex: F
Vaccine: FLUX, MMR
Symptoms: Irritability, Listless, Pyrexia, Rash generalised, Urine analysis normal
Clinical narrative: Patient had a high fever - over 104 degrees as documented by ER doctor using temporal thermometer. From day 6/7 to 10) she was listless and drowsy and extremely irritable. Treatment could only be for fever - TYLENOL & ADVIL. Followed with rash all over body on day 10.
Age: 72.0
Sex: F
Vaccine: TDAP, VARZOS
Symptoms: Injection site erythema, Injection site inflammation, Injection site pruritus, Injection site reaction
Clinical narrative: Site reaction. Local inflammation, redness, severe itching at ZOSTAVAX site.
Age: 68.0
Sex: M
Vaccine: FLU3
Symptoms: Cough, Dry throat, Eye discharge, Headache, Ocular hyperaemia
Clinical narrative: Within 3 hours of vaccination developed dry cough, scratchy dry throat, blurred vision, bloodshot eyes with mucous formation; severe headache developed & stayed all night with ringing ears (tinnitus). Blurred vision & cough subsided in 4 hours from onset but headache continued until next day.
Age: 68.0
Sex: M
Vaccine: FLU3
Symptoms: Throat irritation, Tinnitus, Vision blurred
Clinical narrative: Within 3 hours of vaccination developed dry cough, scratchy dry throat, blurred vision, bloodshot eyes with mucous formation; severe headache developed & stayed all night with ringing ears (tinnitus). Blurred vision & cough subsided in 4 hours from onset but headache continued until next day.
Age: 1.49
Sex: F
Vaccine: FLU3, HEPA
Symptoms: Inappropriate schedule of drug administration, No adverse event
Clinical narrative: Patient came in with her mother and sister for flu shots and had to be seen for a rash. I notice that she was due for Hep-A 9/12 but I failed to notice that it wasn't due until the 20th. I gave her a Hep-A shot 13 days too soon, I told the doctor and called my manager and notified them, no symptoms.
Age: 52.0
Sex: F
Vaccine: TDAP
Symptoms: Unevaluable event
Clinical narrative: None stated.
Age: 72.0
Sex: F
Vaccine: VARZOS, VARZOS
Symptoms: Erythema, Pyrexia, Rash erythematous, Rash vesicular
Clinical narrative: ZOSTAVAX given 9/6/12 - patient noticed redness in arm with vesicular rash & fever 101.2 9/8/12 - redness has lessened now - patient seen in office 9/11/12 - has vesicular, red rash size of silver dollar now.
Age: 72.0
Sex: F
Vaccine: VARZOS, VARZOS
Symptoms: Injection site erythema, Injection site pruritus, Injection site reaction, Pyrexia, Rash vesicular
Clinical narrative: ZOSTAVAX given 9/6/12 - patient noticed redness in arm with vesicular rash & fever 101.2 9/8/12 - redness has lessened now - patient seen in office 9/11/12 - has vesicular, red rash size of silver dollar now.
Age: 4.0
Sex: F
Vaccine: VARCEL
Symptoms: Injection site swelling
Clinical narrative: Swelling of (L) anterior thigh at VZV site.
Age: 11.0
Sex: M
Vaccine: FLUN3, HPV4, MNQ
Symptoms: Erythema, Oedema peripheral
Clinical narrative: Redness, swelling of (R) upper forearm. No pain; warm to touch. Tx: BENADRYL, cool compress; call if increased signs/sym.
Age: 42.0
Sex: F
Vaccine: HEP, VARCEL
Symptoms: Vaccination site erythema
Clinical narrative: Developed local erythema at vaccine site approximately 7 x 4 cm. Advised ice/TYLENOL.
Sex: F
Vaccine: FLU3
Symptoms: Angioedema, Fatigue, Nausea
Clinical narrative: Night of vaccination went to sleep approximately 11pm with fatigue and nausea, awoke with lip angioedema. Unresolved with PO BENADRYL tx by Allergist with 0.50mL epinephrine, PO antihistamine (10mL ZYRTEC) 40 mg  Famotidine and 60 mg Prednisone with improvement of sxs.
Age: 35.0
Sex: F
Vaccine: FLU3
Symptoms: Injection site reaction, Muscle spasticity, Myalgia
Clinical narrative: Received FLUVIRIN in left arm. Even after 8 days, patient still has muscle aches soreness in deltoid down to forearm. Also has spastic activity & muscle lock in some fingers.
Age: 37.0
Sex: F
Vaccine: FLU3, TDAP, VARCEL
Symptoms: Back pain, Chills, Full blood count normal, Headache, Influenza A virus test negative
Clinical narrative: Fever, body aches, chills, headache, leg cramps, backache. Started 4 hours after injections.
Age: 37.0
Sex: F
Vaccine: FLU3, TDAP, VARCEL
Symptoms: Influenza B virus test, Muscle spasms, Pain, Pyrexia
Clinical narrative: Fever, body aches, chills, headache, leg cramps, backache. Started 4 hours after injections.
Age: 65.0
Sex: F
Vaccine: PPV
Symptoms: Back pain, Chest discomfort, Pain in extremity, Swelling
Clinical narrative: Backache, swollen feeling throughout upper body, bilateral arm pain, chest tightness.
Age: 17.0
Sex: M
Vaccine: HPV4
Symptoms: Electrocardiogram, Syncope
Clinical narrative: Sent to hospital determine diagnosis is syncope.
Age: 4.0
Sex: M
Vaccine: DTAP, FLUN3, IPV, MMR, VARCEL
Symptoms: Gait disturbance, Intensive care, Urticaria
Clinical narrative: Hives head to toe & "drunken gait" admitted ICU x 36 hour observation.
Age: 30.0
Sex: F
Vaccine: FLU3
Symptoms: Pruritus, Urticaria
Clinical narrative: Itching, hives. Treatment with BENADRYL and Prednisone.
Sex: F
Vaccine: FLU3, PPV, VARZOS
Symptoms: Injection site pain, Oedema peripheral, Pain in extremity, Skin warm
Clinical narrative: Pt stated that late in evening her arm became sore hot swollen. And became increasingly painful starting from lower injection on right arm.
Age: 74.0
Sex: F
Vaccine: FLU3
Symptoms: Contusion
Clinical narrative: Patient had extensive bruising on arm, shoulder and axillary area. Dr. advised pt to discontinue ASA until bruising gone. Not convinced symptoms are related to the vaccine itself.
Age: 66.0
Sex: F
Vaccine: FLU3, VARZOS, VARZOS
Symptoms: Injection site erythema, Injection site haematoma, Injection site pruritus, Injection site swelling
Clinical narrative: Redness & swelling (approximately 6 inches diameter) at injection site itchiness progressively worse since day of injection also bruising at site of injection (FLUVIRIN).
Age: 66.0
Sex: F
Vaccine: FLU3, VARZOS, VARZOS
Symptoms: Injection site erythema, Injection site pruritus, Injection site swelling, Injection site warmth
Clinical narrative: Redness & swelling (approximately 6 inches diameter) at injection site itchiness progressively worse since day of injection also bruising at site of injection (FLUVIRIN).
Age: 62.0
Sex: F
Vaccine: FLU3, TDAP
Symptoms: Erythema, Swelling face
Clinical narrative: Face red, swollen, around eyes & nose.
Age: 77.0
Sex: M
Vaccine: FLU3
Symptoms: Erythema, Pruritus, Skin warm
Clinical narrative: Patient received HD FLUZONE on 9/12/12, on 9/16/12 he returned to pharmacy because his arm was red, itchy, and hot to touch.
Age: 75.0
Sex: F
Vaccine: FLU3, PPV
Symptoms: Musculoskeletal pain, Oedema peripheral, Pain in extremity
Clinical narrative: Patient said that approximately 5 hours after receiving the PNEUMOVAX vaccination she experienced pain & swelling in her upper arm / shoulder area. She applied heat, iced it, & took an unknown pain reliever.
Age: 60.0
Sex: F
Vaccine: UNK
Symptoms: Injection site pain, Injection site pruritus
Clinical narrative: Stinging & itching at injection site for 1 week, pt. is getting better.
Age: 76.0
Sex: F
Vaccine: PPV
Symptoms: Injection site erythema, Injection site pain, Injection site swelling, Injection site warmth
Clinical narrative: Pt reports redness, swelling, heat, & tenderness to left upper arm since last night (PNEUMOVAX given yesterday at 2pm). Pt has used ice & TYLENOL with some relief. Rx CIPRO for possible cellulitis.
Age: 70.0
Sex: M
Vaccine: FLU3
Symptoms: Dyspnoea, Heart rate irregular, Nausea, Vomiting, Wheezing
Clinical narrative: Approximately 3 hrs. after receiving FLUZONE HD patient began to have trouble breathing. He went to visit his PCP. He was experiencing wheezing, nausea, vomiting, and irregular heartbeat per his PCP.
Age: 35.0
Sex: F
Vaccine: FLU3
Symptoms: Arthralgia, Pain in extremity
Clinical narrative: Flu shot - pt's arm hurt the night of the shot ("very sore"). She took Ibuprofen - dose not reported. Now 3 wks later she still has joint pain in the shoulder of the arm shot was given - no muscle soreness. Pt wanted reported due to joint pain.
Age: 65.0
Sex: M
Vaccine: VARZOS
Symptoms: Injection site reaction, Rash erythematous
Clinical narrative: 9-16-12: Raspberry red rash size of silver dollar at injection site (no pain/itch). Redness surrounding raspberry rash extending over back of arm down to elbow. 9-18-12: Rash improving and starting to fade.
Age: 65.0
Sex: M
Vaccine: PPV
Symptoms: Oedema peripheral
Clinical narrative: Very swollen (Right) upper arm. Recovered next day.
Age: 57.0
Sex: F
Vaccine: FLU3
Symptoms: Chest discomfort, Chills, Cough, Diarrhoea, Eructation
Clinical narrative: Approximately 8 hr after shot began with feeling of something stuck in throat. Proceeded to cough, tightness of chest, belching, diarrhea, chills and an extreme headache that was not relieved by taking my usual treatment of 2 ADVIL. Symptoms persisted til next day.
Age: 57.0
Sex: F
Vaccine: FLU3
Symptoms: Headache, Sensation of foreign body
Clinical narrative: Approximately 8 hr after shot began with feeling of something stuck in throat. Proceeded to cough, tightness of chest, belching, diarrhea, chills and an extreme headache that was not relieved by taking my usual treatment of 2 ADVIL. Symptoms persisted til next day.
Age: 72.0
Sex: F
Vaccine: FLU3
Symptoms: Diarrhoea, Dyspnoea, Feeling cold, Nausea
Clinical narrative: During the evening, patient began to experience labored breathing, nausea, diarrhea and she felt cold at times. No emergency services were rendered.
Sex: U
Vaccine: PPV
Symptoms: Pain in extremity
Clinical narrative: This spontaneous report was received from a nurse in the physician's office who stated that PNEUMOVAX 23 (dose, route and lot # not provided) and other unspecified immunizations, caused sore arms and allergy immunizations did not. Dates were not provided. At the time of the report, the patient's outcome was unknown. Additional information is not expected.
Age: 0.8
Sex: U
Vaccine: RV5
Symptoms: Drug administered to patient of inappropriate age, No adverse event
Clinical narrative: This spontaneous report was received from a Licensed Practical Nurse concerning an 8 months old patient. The nurse stated that she administered ROTATEQ (dose, route and lot # not provided) to patient who was 8 months of age, vaccination date was not provided. No adverse symptoms were reported. Additional information has been requested.
Sex: U
Vaccine: PPV
Symptoms: Expired drug administered, No adverse event
Clinical narrative: This spontaneous report was received from a registered pharmacist refers two patients of unknown age who on 04-SEP-2012, were vaccinated with a 0.5 ml dose of PNEUMOVAX 23 (routes not reported) (lot number 669579/0595AA) that was expired. The vaccine expired on 30-AUG-2012. No adverse symptoms were reported. Attempts are being made to obtain additional information identifying information to distinguish the individual patients mentioned in this report. Additional information will be provided if available. This is one of several reports from the same source. Additional information has been requested.
Sex: U
Vaccine: PPV
Symptoms: Expired drug administered, No adverse event
Clinical narrative: This spontaneous report was received from a registered pharmacist refers to a patient of unknown age who on 10-SEP-2012, was vaccinated with a 0.5 ml dose of PNEUMOVAX 23 (route not reported) (lot number 669579/0595AA) that was expired. The vaccine expired on 30-AUG-2012. No adverse symptoms were reported. This is one of several reports from the same source. Additional information has been requested.
Age: 5.0
Sex: F
Vaccine: MMR
Symptoms: Measles antibody negative
Clinical narrative: This spontaneous report was received form a certified medical assistant refers to an approximately 5 years old female patient with no drug reactions or allergies who on 25-MAR-1996, was vaccinated with the first dose of MMR II and on 21-AUG-2000, was vaccinated with the second dose of MMR II (doses, routes and lot numbers not reported), No other co-suspects were reported. No concomitant medications were reported. The medical assistant reported that on an unknown date, the patient showed no immunity for measles after completing the two doses of MMR II. No treatment was given for the experience. At the time of the report, the patient's outcome was unknown. The relatedness for patient showed no immunity for measles after completing two doses of MMR was unknown for MMR II. Additional information has been requested.
Age: 60.0
Sex: F
Vaccine: VARZOS
Symptoms: Herpes zoster, Rash
Clinical narrative: This spontaneous report as received from a physician refers to a female. Last week, in August 2012, the patient was vaccinated with a dose of ZOSTAVAX (dose route and lot # not reported). Two days after vaccination, in August 2012 the patient got shingles. The patient experienced rash; however the rash was not at the injection site. At the time of the report the patient was recovering from the events. Additional information has been requested.
Age: 23.0
Sex: F
Vaccine: HPV4
Symptoms: Hyperhidrosis, Nausea, Pyrexia
Clinical narrative: This spontaneous report as received from a physician refers to a 23 years old female patient with allergic to shellfish and contrast used for MRI. The patient was vaccinated with dose 1 GARDASIL (lot # reported as 0475AE) in left arm on 04-SEP-2012 (dose and route not reported). No other co-suspects were reported. No concomitant medications were reported. The patient experienced a high fever, sweats and nausea for 3 days. The patient sought unspecified medical attention. The patient did not receive any treatment. At the time of report, the outcome was unknown. Additional information has been requested.
Sex: U
Vaccine: PPV
Symptoms: Expired drug administered, No adverse event
Clinical narrative: This spontaneous report as received from a pharmacist refers to a patient of unknown age. Reporter reported that the patient received PNEUMOVAX 23 (lot #0595AA exp 08/30/2012) on 09/09/2012. No adverse symptoms reported. Additional information has been requested.
Age: 14.0
Sex: F
Vaccine: HPV4
Symptoms: Syncope
Clinical narrative: This is the eighth of eight spontaneous reports as received from a physician refers a female patient between 14-15 years old who throughout this year "in 2012", was vaccinated IM with a dose of GARDASIL (lot # not provided). No other co-suspects were reported. No concomitant medications were reported. The physician stated that the patient suffered from syncope after having GARDASIL vaccination. The syncope was also more prevalent with the first dose given than with subsequent doses. Orange juice was given as treatment. The patient did not seek medical attention. The patient improved before leaving the office. The patient's outcome was recovered. The relatedness for syncope was unknown for GARDASIL. This is one of several reports from the same source. Additional information has been requested.
Age: 11.0
Sex: F
Vaccine: HPV4
Symptoms: Vaginal haemorrhage
Clinical narrative: This spontaneous report was received from a pharmacist refers to a 11 years old female patient with allergy to penicillin who in January, April and July of 2012, was vaccinated intramuscularly with the first, second and third dose of GARDASIL (dose and lot number not reported) respectively. No other co-suspects were reported. Concomitant medications included: PRILOSEC. The pharmacist reported that in May 2012, the patient began to have heavy vaginal bleeding which had not stopped. AVIANE was given as a treatment for the experience by the physician but it had not affected the bleeding. At the time of the report, the patient had not recovered. The relatedness for the patient began to have heavy vaginal bleeding was unknown for GARDASIL. Additional information has been requested.
Age: 14.0
Sex: F
Vaccine: HPV4
Symptoms: Syncope
Clinical narrative: This is the fourth of eight spontaneous reports as received from a physician refers a female patient between 14-15 years old who throughout this year "in 2012", was vaccinated IM with a dose of GARDASIL (lot # not provided). No other co-suspects were reported. No concomitant medications were reported. The physician stated that the patient suffered from syncope after having GARDASIL vaccination. The syncope was also more prevalent with the first dose given than with subsequent doses. Orange juice was given as treatment. The patient did not seek medical attention. The patient improved before leaving the office. The patient's outcome was recovered. The relatedness for syncope was unknown for GARDASIL. This is one of several reports from the same source. Additional information has been requested.
Age: 14.0
Sex: F
Vaccine: HPV4
Symptoms: Syncope
Clinical narrative: This is the sixth of eight spontaneous reports as received from a physician refers a female patient between 14-15 years old who throughout this year "in 2012", was vaccinated IM with a dose of GARDASIL (lot # not provided). No other co-suspects were reported. No concomitant medications were reported. The physician stated that the patient suffered from syncope after having GARDASIL vaccination. The syncope was also more prevalent with the first dose given than with subsequent doses. Orange juice was given as treatment. The patient did not seek medical attention. The patient improved before leaving the office. The patient's outcome was unknown. The relatedness for syncope was unknown for GARDASIL. This is one of several reports from the same source. Additional information has been requested.
Age: 14.0
Sex: F
Vaccine: HPV4
Symptoms: Syncope
Clinical narrative: This is the fifth of eight spontaneous reports as received from a physician refers a female patient between 14-15 years old who throughout this year "in 2012", was vaccinated IM with a dose of GARDASIL (route and lot # not provided). No other co-suspects were reported. No concomitant medications were reported. The physician stated that the patient suffered from syncope after having GARDASIL vaccination. The syncope was also more prevalent with the first dose given than with subsequent doses. Orange juice was given as treatment. The patient did not seek medical attention. The patient improved before leaving the office. The relatedness for syncope was unknown for GARDASIL. This is one of several reports from the same source. Additional information has been requested.
Age: 14.0
Sex: F
Vaccine: HPV4
Symptoms: Syncope
Clinical narrative: This is the third of eight spontaneous reports as received from a physician concerning a female patient between 14-15 years old who throughout this year "in 2012", was vaccinated IM with a dose of GARDASIL (lot # not provided). No other co-suspects were reported. No concomitant medications were reported. The physician stated that the patient suffered from syncope after having GARDASIL vaccination. The syncope was also more prevalent with the first dose given than with subsequent doses. Orange juice was given as treatment. The patient did not seek medical attention. The patient improved before leaving the office. The patient's outcome was recovered. The relatedness for syncope was unknown for GARDASIL. This is one of several reports from the same source. Additional information has been requested.
Age: 14.0
Sex: F
Vaccine: HPV4
Symptoms: Syncope
Clinical narrative: This is the seventh of eight spontaneous reports as received from a physician refers a female patient between 14-15 years old who throughout this year "in 2012", was vaccinated IM with a dose of GARDASIL (lot # not provided). No other co-suspects were reported. No concomitant medications were reported. The physician stated that the patient suffered from syncope after having GARDASIL vaccination. The syncope was also more prevalent with the first dose given than with subsequent doses. Orange juice was given as treatment. The patient did not seek medical attention. The patient improved before leaving the office. The patient's outcome was recovered. The relatedness for syncope was unknown for GARDASIL. This is one of several reports from the same source. Additional information has been requested.
Age: 14.0
Sex: F
Vaccine: HPV4
Symptoms: Syncope
Clinical narrative: This is the second of eight spontaneous reports as received from a physician concerning a female patient between 14-15 years old who throughout this year "in 2012", was vaccinated IM with a dose of GARDASIL (lot # not provided). No other co-suspects were reported. No concomitant medications were reported. The physician stated that the patient suffered from syncope after having GARDASIL vaccination. The syncope was also more prevalent with the first dose given that with subsequent doses. Orange juice was given as treatment. The patient did not seek medical attention. The patient improved before leaving the office. The patient's outcome was unknown. The relatedness for syncope was unknown for GARDASIL. This is one of several reports from the same source. Additional information has been requested.
Sex: F
Vaccine: HPV4
Symptoms: Syncope
Clinical narrative: This is the first of eight spontaneous reports as received from a physician concerning a female patient between 14-15 years old who throughout this year "in 2012", was vaccinated IM with a dose of GARDASIL (lot # not provided). No other co-suspects were reported. No concomitant medications were reported. The physician stated that the patient suffered from syncope after having GARDASIL vaccination. The syncope was also more prevalent with the first dose given than with subsequent doses. Orange juice was given as treatment. The patient did not seek medical attention. The patient improved before leaving the office. Outcome was reported as recovered. The relatedness for syncope was unknown for GARDASIL. This is one of several reports from the same source. Additional information has been requested.
Sex: F
Vaccine: VARZOS
Symptoms: Balance disorder
Clinical narrative: This spontaneous report as received from a physician refers to a female friend of his wife of unknown age with hypothyroidism. The patient was vaccinated with ZOSTAVAX (Lot# unspecified) on an unknown date. No other co-suspects were reported. No concomitant medications were reported. On an unknown date the patient experienced balance disturbance. The patient had an evaluation with her primary care physician and it was felt the balance disturbance was related to her hypothyroidism. The patient was treated with a course of steroid medication and the symptoms resolved. The patient had sought medical attention via office visit. Additional information is not expected.
Sex: U
Vaccine: HEP
Symptoms: Inappropriate schedule of drug administration, No adverse event
Clinical narrative: This spontaneous report as received from a medical assistant refers to a patient of unknown age and gender. On 13-JUL-2012, the patient was vaccinated with dose first dose of RECOMBIVAX HB lot: unspecified. On 27-JUL-2012, the patient was vaccinated with second dose of RECOMBIVAX HB lot: unspecified. On 10-AUG-2012, the patient was vaccinated with third dose of RECOMBIVAX HB lot: unspecified. The medical assistant stated that a patient received the 2nd dose and 3rd dose of RECOMBIVAX HB early. The patient was traveling to other country and the patient did not experienced any known symptoms. Additional information has been requested.