chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 0.56
Sex: M
Vaccine: DTAPIPVHIB, HEPA, PNC
Symptoms: Injection site pain, Pyrexia, Wrong drug administered
Clinical narrative: This case was reported by a consumer and described the occurrence of low grade fever in a 7-month-old male subject who was vaccinated with HAVRIX (GlaxoSmithKline), (non-gsk) PREVNAR and (non-gsk) PENTACEL. A physician or other health care professional has not verified this report. On 2 March 2010 at 15:00 the subject received 1st dose of HAVRIX (unknown, left thigh), unspecified dose of PREVNAR (unknown, unknown thigh) and unspecified dose of PENTACEL (unknown, unknown thigh). On 2 March 2010, at the time of vaccination with HAVRIX, the subject experienced wrong vaccine administered. The mother reported the subject received HAVRIX instead of his 3rd dose in the series of Hepatitis B vaccine "because the vaccine cap was the same color". On 2 March 2010, 6 hours after vaccination with HAVIRX, PENTACEL and PREVNAR, the subject experienced low grade fever and soreness in thigh. The subject's mother indicated that the thigh soreness and low-grade fever could have been caused by other vaccines. At the time of reporting the outcome of the low grade fever and soreness in thigh was unresolved.
Age: 1.0
Sex: M
Vaccine: HEPA, MMR, PNC, VARCEL
Symptoms: Injury associated with device, Product quality issue
Clinical narrative: This case was reported by a healthcare professional and described the occurrence of needle stick injury in a 12-month-old male subject who was vaccinated with HAVRIX (GlaxoSmithKline). Previous and/or concurrent vaccination included MMR II (non-gsk); Merck; unknown; unknown given on 8 March 2010; PREVNAR (non-gsk); Wyeth Labs; unknown; unknown given on 8 March 2010; VARIVAX (non-gsk); Merck; unknown; unknown given on 8 March 2010. On 8 March 2010 the subject received unspecified dose of HAVRIX (.5 ml, unknown, left thigh). On 8 March 2010, at the time of the vaccination with HAVRIX, the subject experienced needle stick injury and pharmaceutical product complaint. The sales representative reported the needles that the healthcare professional was using do not seem to lock on the syringe very well, it was detaching from the syringe while the needle was in the subject's leg. The healthcare professional clarified the needle detached from the syringe while in the subject's leg. "The office was not using a Leur-Lok needle; they were using a regular needle. Nothing adverse resulted and the provider administered a different syringe of HAVRIX; the office had already discarded the syringe". On 8 March 2010, the needle stick injury was resolved. Quality Assurance (QA) results were received on 16 March 2010, who considered the complaint as not verified and suspected that this complaint was probably due to a mishandle by the customer. Follow-up information was received on 23 March 2010 via healthcare professional who reported the events were associated with erroneous administration in which the needle may or may not have been locked into the syringe and/or the TipLock on the syringe may have been defective and unable to hold needle correctly.
Age: 24.0
Sex: F
Vaccine: HEPA, TDAP
Symptoms: Asthenia, Diarrhoea, Malaise, Vomiting
Clinical narrative: This case was reported by a consumer and described the occurrence of sick in a 24-year-old female subject who was vaccinated with HAVRIX (GlaxoSmithKline). A physician or other health care professional has not verified this report. Concurrent medical conditions included allergy to avocado, allergy to onion and allergy to spinach. Previous and/or concurrent vaccination included TDap; manufacturer unspecified; unknown; unknown given in October 2008. The subject stated that she received other vaccines that same day, details not provided. There were no concurrent medications. On an unspecified date in October 2008 the subject received 1st dose of HAVRIX (unknown). On an unspecified date in October 2008, less than one day after vaccination with HAVRIX, the subject experienced diarrhea, vomiting, weakness and sick. The same evening as the vaccination and the next day, the subject reported diarrhea and vomiting; she also had weakness and was sick for approximately one week. At the time of reporting the diarrhea, vomiting, weakness and sick were resolved.
Age: 12.0
Sex: F
Vaccine: HEPA, HEPAB
Symptoms: Drug administration error, Incorrect dose administered, Injection site pain
Clinical narrative: This case was reported by a physician and described the occurrence of injection site soreness in a 12-year-old female subject who was vaccinated with HAVRIX (GlaxoSmithKline), TWINRIX. On 23 March 2010 the subject received 1st dose of HAVRIX at 1440 ELISA units in the right arm and a dose of TWINRIX in the left arm. The dose of HAVRIX given was an inappropriate dose of drug administered. The subject should have received a pediatric dose of HAVRIX. The subject experienced injection site soreness following administration of TWINRIX. The vaccination was also a maladministration (asymptomatic/child too young). At the time of reporting the outcome of injection site soreness was unspecified. The event was considered unrelated to vaccination with HAVRIX and TWINRIX. Follow-up information was received on 13 April 2010 via healthcare professional who reported the subject had no diagnosis. At the time of the report, no other information was provided.
Age: 12.0
Sex: F
Vaccine: DTP, HEPA
Symptoms: Urticaria
Clinical narrative: This case was reported by a healthcare professional via sales representative and described the occurrence of hive in a 12-year-old female subject who was vaccinated with Hepatitis A vaccine (manufacturer unspecified), DTP (A or W not known). Co-suspect medication included 100/50 ADVAIR and Amoxicillin (manufacturer unknown). Concurrent medical conditions included allergy to amoxicillin, penicillin allergy and pneumonia. Previous and/or concurrent vaccination included GARDASIL (non-gsk); non-GSK manufacturer; unknown; unknown given on an unspecified date; MENACTRA (non-gsk); non-GSK manufacturer; unknown; unknown given on an unspecified date. Concurrent medications included Z-PAK. On an unspecified date the subject received unspecified dose of Hepatitis A vaccine (unknown), unspecified dose of DTP (unknown). That same day the subject was diagnosed with pneumonia and prescribed ADVAIR (inhaled) at 1 puff(s) twice per day and Z-PAK dosing was unknown. At an unspecified time after vaccination with DTP, unspecified, Hepatitis A vaccine, and immediately after starting ADVAIR, the subject experienced hives. Treatment with ADVAIR was discontinued. The subject's hives were treated with BENADRYL. On an unspecified date the subject started Amoxicillin, dosing and indication unknown. At an unspecified time after starting Amoxicillin the subject experienced an allergic reaction. At the time of reporting the outcome of the hives was resolved and the allergic reaction was unspecified. The health professional considered the hives were almost certainly related to treatment with ADVAIR.  Nurse is father of a female about 12 or so that received annual vaccines and was diagnosed with pneumonia. ADVAIR and ZPAK were prescribed. Within the same day the child experienced hives. The ADVAIR was stopped and the hives resolved. The ADVAIR was not reintroduced. Also noted that the child was given 50mg of BENADRYL. During report it was noted that child had high sensitivity to some products, as her father does also. It was also stated the she had an allergy to penicillin and amoxicillin. Unknown manufacturer of the amoxicillin and no further information on the allergy reaction to the product. Per the rep, parents, who have medical background, feel strongly the reaction was related strictly to the ADVAIR.
Age: 10.0
Sex: M
Vaccine: HEPA, VARCEL
Symptoms: Injection site erythema, Injection site pustule, Injection site swelling
Clinical narrative: This case was reported by a healthcare professional and described the occurrence of injection site redness in a 10-year-old male subject who was vaccinated with HAVRIX (GlaxoSmithKline). The subject's medical history included allergic rhinitis and allergy to amoxicillin. Concurrent vaccination included VARIVAX (non-gsk); Merck given on 19 May 2010. On 19 May 2010 at 16:20 the subject received 2nd dose of HAVRIX (.5 ml, unknown route, right arm). On 20 May 2010, 1 day after vaccination with HAVRIX, the subject experienced injection site redness, injection site swollen and injection site pustule. The subject was treated with ice. At the time of reporting the events were unresolved. The events were reported to the healthcare professional by the school nurse. Follow-up information was received on 03 June 2010. It was reported that the reactions were just local with onset 20 May 2010. The events resolved by 24 May 2010. It was noted that the area around the injection site was bumpy. Treatment included BENADRYL Cream and ice packs. The 1st HAVRIX injection was given on 03 July 2008.
Age: 2.0
Sex: M
Vaccine: MMR
Symptoms: Rash
Clinical narrative: rash
Age: 50.0
Sex: F
Vaccine: FLU3
Symptoms: Herpes simplex serology negative, VIIth nerve paralysis
Clinical narrative: Facial droop, Bell's Palsy on left side of face
Age: 58.0
Sex: M
Vaccine: PPV
Symptoms: Injection site erythema, Myalgia, Pyrexia, Vaccination site swelling
Clinical narrative: Low grade fever, myalgias, redness & swelling at vaccination site left deltoid. Symptoms developed 24 hours following PNEUMOVAX administration.
Age: 5.0
Sex: M
Vaccine: DTAPIPV, MMR
Symptoms: Asthenia, Chills, Decreased appetite, Injection site erythema, Injection site rash
Clinical narrative: Within 2 days pt, previously well, developed 5x8 cm red, warm rash at injection site, (L) deltoid. Also, viral syndrome with F to 102, chills, weak, vomited x one & poor appetite.
Age: 5.0
Sex: M
Vaccine: DTAPIPV, MMR
Symptoms: Injection site warmth, Pyrexia, Viral infection, Vomiting
Clinical narrative: Within 2 days pt, previously well, developed 5x8 cm red, warm rash at injection site, (L) deltoid. Also, viral syndrome with F to 102, chills, weak, vomited x one & poor appetite.
Age: 38.0
Sex: F
Vaccine: FLU3
Symptoms: Injection site pruritus, Injection site rash, Pruritus
Clinical narrative: Itching of face itching at injection site and rash at injection site.
Age: 12.0
Sex: F
Vaccine: HPV4
Symptoms: Dysarthria, Headache, Paraesthesia, Paraesthesia oral, Speech disorder
Clinical narrative: About 1 hour after vaccine tingling tongue & hand (R), poor speech/articulation, headache.
Age: 0.78
Sex: M
Vaccine: HEP
Symptoms: Febrile convulsion, Pyrexia
Clinical narrative: Fever 105 degrees F febrile seizure.
Age: 61.0
Sex: M
Vaccine: VARZOS
Symptoms: Herpes zoster, Hyperaesthesia, Injection site haematoma, Injection site induration, Pain
Clinical narrative: Itching and sensitivity around right side breast nipple later turning into what appeared to be an open sore.  Area under breast had itching turning into red bumps and then open sores with pain.  Went to family physician on February 29, PM, and was diagnosed with Shingles.  Physician prescribed Mupirocin 2% ointment, Sulfamethoxazole-TMP DS, and Valacyclovir HCL.  Rash and pain still exist at this time however it appears to be slowing going away.
Age: 61.0
Sex: M
Vaccine: VARZOS
Symptoms: Pruritus, Rash erythematous, Skin ulcer
Clinical narrative: Itching and sensitivity around right side breast nipple later turning into what appeared to be an open sore.  Area under breast had itching turning into red bumps and then open sores with pain.  Went to family physician on February 29, PM, and was diagnosed with Shingles.  Physician prescribed Mupirocin 2% ointment, Sulfamethoxazole-TMP DS, and Valacyclovir HCL.  Rash and pain still exist at this time however it appears to be slowing going away.
Age: 31.0
Sex: M
Vaccine: ANTH
Symptoms: Injection site erythema, Injection site pain, Injection site swelling
Clinical narrative: PT had large red swelling at the point of injection (RT Arm IM) pain, tenderness, & erythema. X 3days - treated at BAS with Diphenhydramine 50mg
Age: 31.0
Sex: M
Vaccine: ANTH
Symptoms: Erythema, Injection site erythema, Injection site swelling, Pain
Clinical narrative: PT had severe swelling and redness around injection site. Pain, tenderness, & erythema. X2 days - treated at facility with Diphenhydramine 50 mg
Age: 24.0
Sex: F
Vaccine: PPV
Symptoms: Discomfort, Injection site pain, Insomnia, Listless, Musculoskeletal stiffness
Clinical narrative: Pain and stiffness in arm around injection site, starting a few hours after injection. Stiffness in back, legs, arms (increasing at injection site), pain in calves apx 12 hours after injection. Fever starting apx 20 hours after injection. Restlessness, insomnia (mostly from feeling so uncomfortable) general listlessness, nausea starting this morning (Sunday) productive cough (clear white mucus).
Age: 24.0
Sex: F
Vaccine: PPV
Symptoms: Nausea, Pain in extremity, Productive cough, Pyrexia, Restlessness
Clinical narrative: Pain and stiffness in arm around injection site, starting a few hours after injection. Stiffness in back, legs, arms (increasing at injection site), pain in calves apx 12 hours after injection. Fever starting apx 20 hours after injection. Restlessness, insomnia (mostly from feeling so uncomfortable) general listlessness, nausea starting this morning (Sunday) productive cough (clear white mucus).
Age: 68.0
Sex: F
Vaccine: VARZOS, VARZOS, VARZOS
Symptoms: Herpes zoster, Hypoaesthesia, Paraesthesia, Rash
Clinical narrative: Patient started experiencing tingling on left cheek, then numbness, then rash. On Tuesday, patient went to physician and diagnosed with shingles. Given rx for Valtrex for 1 week.
Age: 68.0
Sex: F
Vaccine: VARZOS, VARZOS, VARZOS
Symptoms: Ear pain, Facial pain, Hypoaesthesia, Hypoaesthesia facial, Paraesthesia
Clinical narrative: Patient started experiencing tingling on left cheek, then numbness, then rash. On Tuesday, patient went to physician and diagnosed with shingles. Given rx for Valtrex for 1 week.
Age: 68.0
Sex: F
Vaccine: VARZOS, VARZOS, VARZOS
Symptoms: Rash
Clinical narrative: Patient started experiencing tingling on left cheek, then numbness, then rash. On Tuesday, patient went to physician and diagnosed with shingles. Given rx for Valtrex for 1 week.
Age: 68.0
Sex: F
Vaccine: VARZOS, VARZOS, VARZOS
Symptoms: Herpes zoster, Rash
Clinical narrative: Patient started experiencing tingling on left cheek, then numbness, then rash. On Tuesday, patient went to physician and diagnosed with shingles. Given rx for Valtrex for 1 week.
Age: 2.0
Sex: F
Vaccine: HEPA
Symptoms: Autoimmune thrombocytopenia, Contusion, Epistaxis, Gingival bleeding, Haemorrhage
Clinical narrative: ITP immune thrombocytopenic purpura  BRUISING, BLOOD SPOTS, BLEEDING GUMS, BLEEDING NOSE, BLOOD IN TEARS  RECIEVED IVIG
Age: 2.0
Sex: F
Vaccine: HEPA
Symptoms: Idiopathic thrombocytopenic purpura, Immunoglobulin therapy, Lacrimal haemorrhage
Clinical narrative: ITP immune thrombocytopenic purpura  BRUISING, BLOOD SPOTS, BLEEDING GUMS, BLEEDING NOSE, BLOOD IN TEARS  RECIEVED IVIG
Age: 1.3
Sex: M
Vaccine: DTAP, FLU3, HIBV, PNC13
Symptoms: Abdominal distension, Abdominal pain lower, Barium double contrast, Intussusception, Ultrasound abdomen abnormal
Clinical narrative: Initial report received on 30 November 2010 from another manufacturer, report # US-WYE-H18156410.  The initial reporter to this manufacturer had been a health care professional.  On 06 December 2010 the report was also received from an additional two manufacturers (report# 1-294758640 and report #WAES 1012USA00233).  The following was verbatim from another manufacturer, report# WAES 1012USA00233: "Initial and follow-up information has been received from agency (manufacturer number US-WYE-H18156410), from a physician concerning a 15 month old male with a birth weight of 6 lbs and no siblings who on 06 October 2010 was vaccinated intramuscularly with a dose of PEDVAXHIB (OMPC) (Lot# 666238/1485Y).  Secondarily suspected vaccinations included a dose of PREVNAR 13, a dose of FLUZONE (U3716AA, route intramuscular) and a dose of DAPTACEL (C3381AA, route intramuscular, manufacturer Sanofi) on 06 October 2010, respectively.  Relevant medical history was not provided.  Concomitant medications were not reported.  On 07 October 2010 the patient experienced intussusception with symptoms of lower quadrant pain and swelling accompanied by vomiting.  On 08 October 2010 he was taken to the emergency room, abdominal ultrasound revealed intussusception.  On the same day, the patient was treated with air contrast enema; a tube was inserted into his rectum so that air could be introduced to the bowel.  The treatment was successful and the patient recovered and was discharged to home.  The patient was not admitted to the hospital.  The physician suspected that any of the vaccinations received on 06 October 2010 could have a causal relationship to the events that followed, however he has never heard of these events associated with PREVNAR 13.  No additional information was available at the time of this report".  The product diphtheria toxoid (+) tetanus toxoid (C3381AA, route intramuscular, manufacturer Sanofi) was identified as a sanofi pasteur product, DAPTACEL, lot number C3881A.  Documents held by sender: None.
Age: 1.3
Sex: M
Vaccine: DTAP, FLU3, HIBV, PNC13
Symptoms: Vomiting
Clinical narrative: Initial report received on 30 November 2010 from another manufacturer, report # US-WYE-H18156410.  The initial reporter to this manufacturer had been a health care professional.  On 06 December 2010 the report was also received from an additional two manufacturers (report# 1-294758640 and report #WAES 1012USA00233).  The following was verbatim from another manufacturer, report# WAES 1012USA00233: "Initial and follow-up information has been received from agency (manufacturer number US-WYE-H18156410), from a physician concerning a 15 month old male with a birth weight of 6 lbs and no siblings who on 06 October 2010 was vaccinated intramuscularly with a dose of PEDVAXHIB (OMPC) (Lot# 666238/1485Y).  Secondarily suspected vaccinations included a dose of PREVNAR 13, a dose of FLUZONE (U3716AA, route intramuscular) and a dose of DAPTACEL (C3381AA, route intramuscular, manufacturer Sanofi) on 06 October 2010, respectively.  Relevant medical history was not provided.  Concomitant medications were not reported.  On 07 October 2010 the patient experienced intussusception with symptoms of lower quadrant pain and swelling accompanied by vomiting.  On 08 October 2010 he was taken to the emergency room, abdominal ultrasound revealed intussusception.  On the same day, the patient was treated with air contrast enema; a tube was inserted into his rectum so that air could be introduced to the bowel.  The treatment was successful and the patient recovered and was discharged to home.  The patient was not admitted to the hospital.  The physician suspected that any of the vaccinations received on 06 October 2010 could have a causal relationship to the events that followed, however he has never heard of these events associated with PREVNAR 13.  No additional information was available at the time of this report".  The product diphtheria toxoid (+) tetanus toxoid (C3381AA, route intramuscular, manufacturer Sanofi) was identified as a sanofi pasteur product, DAPTACEL, lot number C3881A.  Documents held by sender: None.
Age: 31.0
Sex: M
Vaccine: ANTH
Symptoms: Erythema, Swelling
Clinical narrative: Swelling and redness greater than 130mm but not extending past the elbow.
Age: 11.0
Sex: F
Vaccine: HPV4, HPV4, MNQ, TDAP
Symptoms: Apathy, Blood heavy metal test, Convulsion, Electroencephalogram, Liver function test
Clinical narrative: Information has been received from a physician concerning an approximately11 year old female who in October 2008, was intramuscularly vaccinated with the first dose of GARDASIL (lot# not reported) and the third dose of 0.5ml GARDASIL (lot# not reported) in February 2009. After the third dose, the patient experienced seizures and developed a lack a motivation to go to school because she was in pain. Heavy metal screen, MRI, EEG and liver function testing were performed with no results reported. The patient sought unspecified medical attention. At the time of reporting, the patient had not recovered. Upon internal review, the seizure was determined to be an other important medical event. Additional information has been requested.
Age: 11.0
Sex: F
Vaccine: HPV4, HPV4, MNQ, TDAP
Symptoms: Nuclear magnetic resonance imaging, Pain
Clinical narrative: Information has been received from a physician concerning an approximately11 year old female who in October 2008, was intramuscularly vaccinated with the first dose of GARDASIL (lot# not reported) and the third dose of 0.5ml GARDASIL (lot# not reported) in February 2009. After the third dose, the patient experienced seizures and developed a lack a motivation to go to school because she was in pain. Heavy metal screen, MRI, EEG and liver function testing were performed with no results reported. The patient sought unspecified medical attention. At the time of reporting, the patient had not recovered. Upon internal review, the seizure was determined to be an other important medical event. Additional information has been requested.
Age: 11.0
Sex: F
Vaccine: HPV4, HPV4, MNQ, TDAP
Symptoms: Blood glucose normal, Blood test normal, Chiropractic, Convulsion, Electroencephalogram abnormal
Clinical narrative: Information has been received from a physician concerning an approximately11 year old female who in October 2008, was intramuscularly vaccinated with the first dose of GARDASIL (lot# not reported) and the third dose of 0.5ml GARDASIL (lot# not reported) in February 2009. After the third dose, the patient experienced seizures and developed a lack a motivation to go to school because she was in pain. Heavy metal screen, MRI, EEG and liver function testing were performed with no results reported. The patient sought unspecified medical attention. At the time of reporting, the patient had not recovered. Upon internal review, the seizure was determined to be an other important medical event. Additional information has been requested.
Age: 11.0
Sex: F
Vaccine: HPV4, HPV4, MNQ, TDAP
Symptoms: Liver function test, Nuclear magnetic resonance imaging normal, Scan abnormal
Clinical narrative: Information has been received from a physician concerning an approximately11 year old female who in October 2008, was intramuscularly vaccinated with the first dose of GARDASIL (lot# not reported) and the third dose of 0.5ml GARDASIL (lot# not reported) in February 2009. After the third dose, the patient experienced seizures and developed a lack a motivation to go to school because she was in pain. Heavy metal screen, MRI, EEG and liver function testing were performed with no results reported. The patient sought unspecified medical attention. At the time of reporting, the patient had not recovered. Upon internal review, the seizure was determined to be an other important medical event. Additional information has been requested.
Age: 11.0
Sex: F
Vaccine: HPV4, HPV4, MNQ, TDAP
Symptoms: Apathy, Blood heavy metal test, Convulsion, Electroencephalogram, Liver function test
Clinical narrative: See attached - "Patient timeline - Seizures".
Age: 11.0
Sex: F
Vaccine: HPV4, HPV4, MNQ, TDAP
Symptoms: Nuclear magnetic resonance imaging, Pain
Clinical narrative: See attached - "Patient timeline - Seizures".
Age: 11.0
Sex: F
Vaccine: HPV4, HPV4, MNQ, TDAP
Symptoms: Blood glucose normal, Blood test normal, Chiropractic, Convulsion, Electroencephalogram abnormal
Clinical narrative: See attached - "Patient timeline - Seizures".
Age: 11.0
Sex: F
Vaccine: HPV4, HPV4, MNQ, TDAP
Symptoms: Liver function test, Nuclear magnetic resonance imaging normal, Scan abnormal
Clinical narrative: See attached - "Patient timeline - Seizures".
Age: 36.0
Sex: F
Vaccine: PPV, TDAP
Symptoms: Chills, Dehydration, Erythema, Influenza virus test negative, Injection site reaction
Clinical narrative: Information has been received from a physician concerning a 36 year old female patient who on 25-JAN-2011 was vaccinated with a dose of PNEUMOVAX 23 (Expire date and route not reported). On 26-JAN-2011 at 14:00, the patient developed a fever of 104 to 105 degrees farenheit. The patient returned to the clinic on 28-JAN-2011 and was experiencing body chills. It was also documented that the patient had a local reaction at the injection site that was 10x10 centimeters. Patient was given an intravenous bolus for dehydration as well as intravenous fluids and SOLUMEDROL as well. On an unspecified date, a flu test was performed and result was negative. Therapy with PNEUMOVAX 23 was discontinued. At the time of the report, patient had improved after stopping therapy (also reported as unspecified present status). Follow up information has been received from a Registered Nurse, concerning a 36 year old female Registered Nurse with no known allergies, asthma, gastrooesophageal reflux disease (GERD) and hypothiroid no known drug allergies and no illness at the time of vaccination, who on 25-JAN-2011 in the morning was vaccinated intramuscularly in the right deltoid with the first dose of PNEUMOVAX 23. Concomitant therapy included a dose of ADACEL (Lot #C3518AA) administered on 25-JAN-2010 in the morning, intramuscularly on the left deltoid. The nurse reported that on the next day (on 26-JAN-2011) at 13:00, patient started having body aches, then temperature raised to 105 farenheit degrees, severe body aches, local reaction noted to right arm, redness, pain, swelling (10 x 10). Ran temperature for 48 hours. On an unspecified date, patient had 2 flu swab test performed and results were negative. On an unspecified date, patient had fluid bolus at clinic and was given 80 mg of intravenous SOLUMEDROL. At the time of the report, patient had recovered from severe body aches, temperature raised to 105 farenheit degrees, local reaction noted to right arm, redness, pain and swelling. The events required medical/surgical intervention. Additional information has been requested.
Age: 36.0
Sex: F
Vaccine: PPV, TDAP
Symptoms: Local reaction, Oedema peripheral, Pain, Pain in extremity, Pyrexia
Clinical narrative: Information has been received from a physician concerning a 36 year old female patient who on 25-JAN-2011 was vaccinated with a dose of PNEUMOVAX 23 (Expire date and route not reported). On 26-JAN-2011 at 14:00, the patient developed a fever of 104 to 105 degrees farenheit. The patient returned to the clinic on 28-JAN-2011 and was experiencing body chills. It was also documented that the patient had a local reaction at the injection site that was 10x10 centimeters. Patient was given an intravenous bolus for dehydration as well as intravenous fluids and SOLUMEDROL as well. On an unspecified date, a flu test was performed and result was negative. Therapy with PNEUMOVAX 23 was discontinued. At the time of the report, patient had improved after stopping therapy (also reported as unspecified present status). Follow up information has been received from a Registered Nurse, concerning a 36 year old female Registered Nurse with no known allergies, asthma, gastrooesophageal reflux disease (GERD) and hypothiroid no known drug allergies and no illness at the time of vaccination, who on 25-JAN-2011 in the morning was vaccinated intramuscularly in the right deltoid with the first dose of PNEUMOVAX 23. Concomitant therapy included a dose of ADACEL (Lot #C3518AA) administered on 25-JAN-2010 in the morning, intramuscularly on the left deltoid. The nurse reported that on the next day (on 26-JAN-2011) at 13:00, patient started having body aches, then temperature raised to 105 farenheit degrees, severe body aches, local reaction noted to right arm, redness, pain, swelling (10 x 10). Ran temperature for 48 hours. On an unspecified date, patient had 2 flu swab test performed and results were negative. On an unspecified date, patient had fluid bolus at clinic and was given 80 mg of intravenous SOLUMEDROL. At the time of the report, patient had recovered from severe body aches, temperature raised to 105 farenheit degrees, local reaction noted to right arm, redness, pain and swelling. The events required medical/surgical intervention. Additional information has been requested.
Age: 0.51
Sex: M
Vaccine: RV5
Symptoms: Culture stool positive, Dehydration, Diarrhoea, Intensive care, Rotavirus infection
Clinical narrative: Information has been received from a nurse concerning a 6 month old male with no pertinent medical history or known drug allergies who on 19-SEP-2008, 30-OCT-2008 and 27-JAN-2009 was vaccinated PO with the first, second and third dose of ROTATEQ respectively, (lot #: 1st dose 661032/0469X; 2nd dose 661429/0594X; 3rd dose 662801/1102X). On 15-FEB-2011 the patient was admitted to the hospital (intensive care unit) with severe rotavirus confirmed by stool culture. He was vomiting and had diarrhea and also dehydrated. The patient was treated with intravenous (IV) fluids. On 17-FEB-2011 the patient recovered from severe rotavirus and dehydration. He was released from hospital on the same day. The patient continued to do well. Severe rotavirus and dehydrated were considered to be immediately life-threatening and not disabling by the reporter. No further information is available. Lot checks have been initiated.
Age: 0.51
Sex: M
Vaccine: RV5
Symptoms: Rotavirus test positive, Vomiting
Clinical narrative: Information has been received from a nurse concerning a 6 month old male with no pertinent medical history or known drug allergies who on 19-SEP-2008, 30-OCT-2008 and 27-JAN-2009 was vaccinated PO with the first, second and third dose of ROTATEQ respectively, (lot #: 1st dose 661032/0469X; 2nd dose 661429/0594X; 3rd dose 662801/1102X). On 15-FEB-2011 the patient was admitted to the hospital (intensive care unit) with severe rotavirus confirmed by stool culture. He was vomiting and had diarrhea and also dehydrated. The patient was treated with intravenous (IV) fluids. On 17-FEB-2011 the patient recovered from severe rotavirus and dehydration. He was released from hospital on the same day. The patient continued to do well. Severe rotavirus and dehydrated were considered to be immediately life-threatening and not disabling by the reporter. No further information is available. Lot checks have been initiated.
Age: 64.0
Sex: M
Vaccine: VARZOS
Symptoms: Aphthous stomatitis, Blood test
Clinical narrative: Information has been received from a 67 year old male consumer with no pertinent medical history and drug reactions/allergies to sulfur, penicillin and strawberries, who on 19-DEC-2007 was vaccinated with a dose of ZOSTAVAX (Merck) (lot number not provided). Concomitant therapy included morphine, FAMVIR and topical lidocaine. On 16-JAN-2011 the patient was diagnosed with aphthous stomatitis and was hospitalized from 17-JAN-2011 to 22-JAN-2011. Blood tests were performed daily (results not provided). On an unspecified date the patient recovered. No further information is available.
Age: 50.0
Sex: F
Vaccine: VARZOS
Symptoms: Death, Haematoma
Clinical narrative: Information has been received from a doctor of pharmacy concerning a female patient in her 50's, who in October 2010, was vaccinated with a 0.65 ml dose of ZOSTAVAX (Merck) (Lot # not reported). Concomitant therapy included COUMADIN. The pharmacist reported that the patient received a shot of the ZOSTAVAX (Merck) and then was rushed to the hospital with a hematoma. After being admitted to the hospital the patient passed away, in October 2010, "a week after her shot". The pharmacist was not sure if it was due to the ZOSTAVAX (Merck) or not, and she was also not sure of the length of time between the patient getting the ZOSTAVAX (Merck) and being to the hospital. The pharmacist considered that the hematoma and that the patient "passed away" to be life threatening. Additional information has been requested.
Age: 4.0
Sex: M
Vaccine: PPV
Symptoms: Abasia, Decreased appetite, Infection, Injection site erythema, Injection site pain
Clinical narrative: Unable to walk for 2 days, grapefruit size swelling and red/purple color skin at shot site location, fever 104, not eating, pain, muscle weakness, took to facility 3/06/2011 at 11:00 AM and got Bactrim antibiotic for tissue infection and was able to walk a little better that night starting at 5:00 PM and redness is light pink now 3/07/2011 at 9:00 AM and eating and fever is down, still soreness in the leg.
Age: 4.0
Sex: M
Vaccine: PPV
Symptoms: Injection site swelling, Muscular weakness, Pyrexia, White blood cell count increased
Clinical narrative: Unable to walk for 2 days, grapefruit size swelling and red/purple color skin at shot site location, fever 104, not eating, pain, muscle weakness, took to facility 3/06/2011 at 11:00 AM and got Bactrim antibiotic for tissue infection and was able to walk a little better that night starting at 5:00 PM and redness is light pink now 3/07/2011 at 9:00 AM and eating and fever is down, still soreness in the leg.
Age: 1.0
Sex: F
Vaccine: HIBV, MMR, PNC13, VARCEL
Symptoms: Injection site rash
Clinical narrative: Mother noticed bumps around site and called clinic following morning.   No fever reported.
Age: 48.0
Sex: F
Vaccine: MMR, VARCEL
Symptoms: Injection site erythema, Injection site induration, Injection site pain, Injection site pruritus, Injection site swelling
Clinical narrative: Left arm injection site and area around it became red swolllen hard and warm to the touch and painful and itchy. Swollen hardness and redness increased but redness and hardness of area decreased some on day #4.
Age: 48.0
Sex: F
Vaccine: MMR, VARCEL
Symptoms: Injection site warmth
Clinical narrative: Left arm injection site and area around it became red swolllen hard and warm to the touch and painful and itchy. Swollen hardness and redness increased but redness and hardness of area decreased some on day #4.
Age: 19.0
Sex: M
Vaccine: SMALL, SMALL
Symptoms: Vaccination complication
Clinical narrative: Self innoculator. Secondary site next to primary with one suspect satellite lesion proximal to both.
Age: 19.0
Sex: M
Vaccine: SMALL, SMALL
Symptoms: Post vaccination autoinoculation, Vaccination complication
Clinical narrative: Self innoculator. Secondary site next to primary with one suspect satellite lesion proximal to both.
Age: 55.0
Sex: F
Vaccine: UNK
Symptoms: Injection site erythema, Injection site swelling
Clinical narrative: REDNESS AND SWELLING TO INJECTION SITE
Age: 1.25
Sex: F
Vaccine: MMRV
Symptoms: Febrile convulsion
Clinical narrative: Febrile seizure on 3/1/11.
Age: 0.35
Sex: M
Vaccine: DTAPIPVHIB, PNC13, RV5, DTAPIPVHIB
Symptoms: Endotracheal intubation, Haemophilus test positive, Intensive care, Malaise, Respiratory distress
Clinical narrative: Initial report was received from a health care professional on 23 February 2011. A six month-old male patient who had received 2 previous doses of PENTACEL on the proper schedule (lot number, route, site and dates of administration not reported), became very sick. The patient was reported to be in severe respiratory distress. He was intubated and hospitalized in the intensive care unit (dates not reported). Laboratory studies were positive for Haemophilus B-Biotype III. Treatments were not reported. The patient had no illness at the time of prior vaccinations and it was unknown if he had any adverse events following the prior vaccinations. No further information was available at the time of the report. The patient's outcome was reported as recovered. Documents held by sender: none.
Age: 12.0
Sex: F
Vaccine: HPV4
Symptoms: Urinary tract infection, Vaccine positive rechallenge
Clinical narrative: Patient develops UTI symptoms after each GARDASIL injection.
Age: 1.01
Sex: F
Vaccine: FLU3, HEPA, MMR, PNC13, VARCEL
Symptoms: Rash
Clinical narrative: Patient was seen at the hospital and they saw rash and reported to health department. Child was not seen at Dr office.
Age: 45.0
Sex: F
Vaccine: FLU3
Symptoms: Injection site urticaria, Pruritus, Rash erythematous, Urticaria
Clinical narrative: Received vaccine on 1-10-11, signs & symptoms: "red whelping rash" "arm locked up" x "2 days" "intense itching" on assessment of patient red whelps noted on (R) forearm and upper (R) arm. Patient has been seen on following dates for above problems. 1-25-11, 2-7-11, 2-14-11, 2-22-11, 2-23-11.
Age: 1.47
Sex: F
Vaccine: DTAP, HEPA, HIBV
Symptoms: Body temperature increased, Grand mal convulsion, Upper respiratory tract infection
Clinical narrative: The day after vaccination, pt experienced generalized tonic-clonic seizure lasting 10 seconds, with return back to baseline post event. No fever noted prior to event, however temperature when patient presented to office was 101.8 (ax). Mild URI sx also noted, but exam is reassuring and nonfocal. MOTRIN 1 tsp given (100mg/5mL).
Age: 18.0
Sex: M
Vaccine: HEPA
Symptoms: Unevaluable event
Clinical narrative: Adult Hep A was given to patient.
Age: 49.0
Sex: F
Vaccine: FLU3, TDAP
Symptoms: Pruritus, Rash
Clinical narrative: Pt had tdap and Flu shot 020811. Broke out in rash/itching 2 days after shots. Was seen by Dr. on 021011. Prescribed BENADRYL. Not resolved. Saw pt again on 021111 at which time I went to his office to evaluate rash on extrem. & trunk. Dr. tx'd pt with Cortisone shot that resolved rash.
Age: 1.0
Sex: M
Vaccine: VARCEL
Symptoms: Injection site reaction, Rash erythematous
Clinical narrative: Enlarging erythematous "bump" at (R) thigh, no fever reported.
Sex: F
Vaccine: FLU3
Symptoms: Anti-cyclic citrullinated peptide antibody negative, Arthralgia, Asthenia, Blood thyroid stimulating hormone normal, C-reactive protein increased
Clinical narrative: Initial report received from a health care professional (physician) on 24 Feb 2011: This patient was vaccinated with FLUVIRIN (batch number: 70619) 0.5 ml on an unspecified date in Nov 2006.  Twelve hours post vaccination, the patient developed myalgias, joint pain and weakness.  The patient visited multiple physicians with multiple diagnosis including polymyositis and arthralgia (probably no biopsy was ever done as per the reporter).  The patient exhibited difficulty ambulating.  On an unknown date, the patient had elevated inflammatory markers (C-reactive protein, ESR of 48 and RF of 91).  The thyroid stimulating hormone, transaminases were negative and there was no CCP (cyclic citrullinated).  The outcome of the events was not reported.
Sex: F
Vaccine: FLU3
Symptoms: Gait disturbance, Inflammatory marker increased, Myalgia, Polymyositis, Red blood cell sedimentation rate increased
Clinical narrative: Initial report received from a health care professional (physician) on 24 Feb 2011: This patient was vaccinated with FLUVIRIN (batch number: 70619) 0.5 ml on an unspecified date in Nov 2006.  Twelve hours post vaccination, the patient developed myalgias, joint pain and weakness.  The patient visited multiple physicians with multiple diagnosis including polymyositis and arthralgia (probably no biopsy was ever done as per the reporter).  The patient exhibited difficulty ambulating.  On an unknown date, the patient had elevated inflammatory markers (C-reactive protein, ESR of 48 and RF of 91).  The thyroid stimulating hormone, transaminases were negative and there was no CCP (cyclic citrullinated).  The outcome of the events was not reported.
Sex: F
Vaccine: FLU3
Symptoms: Rheumatoid factor increased, Transaminases
Clinical narrative: Initial report received from a health care professional (physician) on 24 Feb 2011: This patient was vaccinated with FLUVIRIN (batch number: 70619) 0.5 ml on an unspecified date in Nov 2006.  Twelve hours post vaccination, the patient developed myalgias, joint pain and weakness.  The patient visited multiple physicians with multiple diagnosis including polymyositis and arthralgia (probably no biopsy was ever done as per the reporter).  The patient exhibited difficulty ambulating.  On an unknown date, the patient had elevated inflammatory markers (C-reactive protein, ESR of 48 and RF of 91).  The thyroid stimulating hormone, transaminases were negative and there was no CCP (cyclic citrullinated).  The outcome of the events was not reported.
Age: 13.0
Sex: F
Vaccine: FLU3, HPV4
Symptoms: Rash, Rash erythematous
Clinical narrative: Receive Flu (Influenza) & 3rd HPV, at home developed mask like rash, erythematous on entire face. No fever or other systemic signs.
Age: 4.0
Sex: F
Vaccine: DTAP, FLU3, IPV, MMR, PNC, VARCEL
Symptoms: Chills
Clinical narrative: Rigors lasting approx 30 minutes. Alert entire time. Went to emergency room at approx 1am 2-26-11. Rigors ended prior to ER exam.
Sex: M
Vaccine: FLU3
Symptoms: Arrhythmia
Clinical narrative: Combined initial reports received from physician on 24 Feb 2011 and 25 Feb 2011: This patient received FLUVIRIN (batch number 11259701) intramuscularly on an unknown date.  The patient developed arrhythmia.  No other information was reported.
Age: 60.0
Sex: F
Vaccine: VARZOS
Symptoms: Fatigue, Induration, Influenza like illness, Injection site inflammation, Injection site swelling
Clinical narrative: Flu like symptoms including achy, fatigue swelling & inflammation at injection site. Hard tissue spot & heated.
Age: 60.0
Sex: F
Vaccine: VARZOS
Symptoms: Pain, Skin warm
Clinical narrative: Flu like symptoms including achy, fatigue swelling & inflammation at injection site. Hard tissue spot & heated.
Age: 4.0
Sex: F
Vaccine: DTAPIPV, MMR, VARCEL
Symptoms: Injection site cellulitis
Clinical narrative: Large area of cellulitis around KINRIX & MMR site. Small area of cellulitis around Varicella.
Age: 23.0
Sex: F
Vaccine: TDAP
Symptoms: Erythema, Mobility decreased, Pain, Pain in extremity, Skin warm
Clinical narrative: Next day (6cm long - 3 1/2cm) tall bright red risen area painful and hot. Pain in arm, difficult to lift arm. Hurts to touch.
Age: 28.0
Sex: F
Vaccine: TDAP
Symptoms: Abdominal pain upper, Nausea, Urticaria
Clinical narrative: 4:00pm - stomach ache & nausea 6:00pm - hives - no respiratory problems - talked with ER - took BENADRYL - symptoms resolved after approx 1/2 hour - never any reaction or discomfort at injection site.
Age: 5.0
Sex: M
Vaccine: DTAPIPV, MMR, VARCEL
Symptoms: Injection site erythema, Injection site swelling, Swelling face
Clinical narrative: (L) arm became swollen & red from elbow to (L) deltoid then increased to swelling (L) clavicle & (L) side of face - took to MD - MD recommends no further DTPs.
Age: 0.42
Sex: M
Vaccine: DTAPIPVHIB, HEP, PNC
Symptoms: Body temperature increased, Dehydration, Diarrhoea, Vomiting
Clinical narrative: Per mom, child had temp of 103.2, vomiting & diarrhea day after immunizations; says she took child to Med Ctr same day, was admitted for "dehydration".
Age: 49.0
Sex: F
Vaccine: FLU3
Symptoms: Cough, Dyspnoea, Wheezing
Clinical narrative: Exactly 2hr after administration. I became wheezy & was coughing. This progressed to difficulty breathing, only able to speak 1 word sentence. Took 25mg BENADRYL po - total time of event 1 1/2 hr.
Age: 17.0
Sex: M
Vaccine: FLU3, PPV
Symptoms: Injection site erythema, Injection site swelling, Pyrexia
Clinical narrative: Positive redness, swelling (L) upper arm fever 103.
Age: 1.02
Sex: F
Vaccine: HIBV, MMR, PNC, VARCEL
Symptoms: Induration, Rash macular, Skin discolouration, Skin lesion
Clinical narrative: Received HiB #4, PREVNAR #4, Varicella #1 and MMR #1 on 02/14/11 / on 02-24-11 pt. had a rash - (see attached note).
Age: 41.0
Sex: F
Vaccine: TDAP
Symptoms: Axillary pain, Cellulitis, Pyrexia, Subcutaneous abscess
Clinical narrative: Fever of 104.8 for 2 days. Painful left armpit with cellulitis and abscess. Start Keflex Capsule, 500 mg, Orally, 20, 1 capsule, every 6 hrs, 5 day(s), Refills 0 Start Benadryl Capsule, 25 MG, Orally, 1 capsule, tidm PRN until symptoms resolve
Age: 48.0
Sex: F
Vaccine: FLU3
Symptoms: Nausea, Rash, Urticaria
Clinical narrative: complaint of rash, hives on face and neck and nausea a few hours following vaccination
Age: 36.0
Sex: M
Vaccine: FLU3
Symptoms: Dehydration, Vomiting
Clinical narrative: SEVERE VOMITING, DEHYDRATION
Age: 1.2
Sex: M
Vaccine: HEPA, MMRV
Symptoms: Erythema, Pyrexia, Rash generalised
Clinical narrative: Low grade fever for 4 days prior to 3/7/11 and fine red rash all over body.
Age: 17.0
Sex: F
Vaccine: HPV4
Symptoms: Abdominal pain, Diarrhoea
Clinical narrative: On Wednesday, 3/2/11, pt started having severe abdominal pain. She then started with diarrhea, no vomiting or nausea. As of 3/7/11, pt's symptoms have resolved.
Age: 50.0
Sex: F
Vaccine: PPV
Symptoms: Erythema, Feeling hot, Pain, Swelling
Clinical narrative: Right deltoid swelling, warmth, erythema and painful to touch. Took MOTRIN 800mg last dose 3/6/11.
Age: 0.78
Sex: F
Vaccine: DTAPHEPBIP, HIBV, PNC13
Symptoms: Eye swelling
Clinical narrative: Bilateral periorbital swelling down onto cheeks.
Age: 66.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site swelling, Rash, Rash pruritic
Clinical narrative: Itchy bumps on neck that later progressed to face. Swelling at injection site that was size of palm of her hand. Patient saw primary care dr on 3/7/2011 and he "wanted to let it play out" so pt would get immunity from vaccine. Patient was using aloe on spots and taking Benadryl for itching. Dr added Pepcid to regimen for itching relief.
Age: 0.21
Sex: M
Vaccine: HIBV
Symptoms: Abdominal discomfort, Constipation, Irritability, Pyrexia
Clinical narrative: Constipation, irritability, upset stomach, fever.
Age: 13.0
Sex: M
Vaccine: VARCEL, HEPA, MNQ, VARCEL
Symptoms: Varicella post vaccine
Clinical narrative: Patient contracted chicken pox after receiving a chicken pox vaccination.
Age: 13.0
Sex: M
Vaccine: VARCEL, HEPA, MNQ, VARCEL
Symptoms: Rash vesicular, Varicella post vaccine
Clinical narrative: Patient contracted chicken pox after receiving a chicken pox vaccination.
Age: 58.0
Sex: M
Vaccine: PPV, PPV
Symptoms: Asthenia, Dysstasia, Fatigue, Joint swelling, Pain
Clinical narrative: As I left the clinic, returning to my car, I noticed that I was beginning to feel tired and that I was becoming a little congested.  By 7 PM my left arm was so sore that I could not move it with out experiancing severe pain. I was unable to stand or sit for very long at a time. Lying down was the only was the only way I could get any relief at all.  Extremely weak when I tried to move around. I took aspirin for the pain. I really do not remember much about the rest of Wednesday night.  Thursday was somewhat better.  But was awfuly weak. I did not have very much use of my left arm. The swelling in my joints had gone down some but not all the way. Friday, most all the swelling had gone away and most of the soreness and pain.
Age: 58.0
Sex: M
Vaccine: PPV, PPV
Symptoms: Pain in extremity, Respiratory tract congestion
Clinical narrative: As I left the clinic, returning to my car, I noticed that I was beginning to feel tired and that I was becoming a little congested.  By 7 PM my left arm was so sore that I could not move it with out experiancing severe pain. I was unable to stand or sit for very long at a time. Lying down was the only was the only way I could get any relief at all.  Extremely weak when I tried to move around. I took aspirin for the pain. I really do not remember much about the rest of Wednesday night.  Thursday was somewhat better.  But was awfuly weak. I did not have very much use of my left arm. The swelling in my joints had gone down some but not all the way. Friday, most all the swelling had gone away and most of the soreness and pain.
Age: 58.0
Sex: M
Vaccine: PPV, PPV
Symptoms: Unevaluable event
Clinical narrative: As I left the clinic, returning to my car, I noticed that I was beginning to feel tired and that I was becoming a little congested.  By 7 PM my left arm was so sore that I could not move it with out experiancing severe pain. I was unable to stand or sit for very long at a time. Lying down was the only was the only way I could get any relief at all.  Extremely weak when I tried to move around. I took aspirin for the pain. I really do not remember much about the rest of Wednesday night.  Thursday was somewhat better.  But was awfuly weak. I did not have very much use of my left arm. The swelling in my joints had gone down some but not all the way. Friday, most all the swelling had gone away and most of the soreness and pain.
Age: 0.41
Sex: M
Vaccine: DTAP, HEP
Symptoms: Abdominal discomfort, Constipation, Irritability, Pyrexia
Clinical narrative: Constipation, irritability, fever, upset stomach.
Age: 1.26
Sex: M
Vaccine: DTAP, HEPA, MMR, PNC, VARCEL
Symptoms: Herpes zoster, Rash
Clinical narrative: RASH ON RIGHT SIDE OF TRUNK, DX: SHINGLES. TX: ACYCLOVIR