chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 0.53
Sex: M
Vaccine: DTAPIPVHIB, PNC13, RV1, DTAPIPVHIB, PPV, RV1
Symptoms: Incorrect route of drug administration, No adverse event
Clinical narrative: This case was reported by a healthcare professional (nurse) and described the occurrence of injection site redness in a 6-month-old male subject who was vaccinated with ROTARIX (GlaxoSmithKline), PENTACEL and pneumococcal vaccines (non-gsk). Concurrent vaccination included rotavirus vaccine (non-gsk); non-GSK manufacturer; unknown given on an unspecified date. On 1 June 2012 the subject received a dose of ROTARIX (intramuscular, unknown) as the 3rd dose to complete ROTATEQ series, unspecified dose of PENTACEL (intramuscular, unknown), unspecified dose of pneumococcal vaccines (Non-GSK) (intramuscular, unknown) and experienced inappropriate route of vaccination with ROTARIX and interchange of vaccine products with ROTARIX. The ROTARIX was administered by intramuscular injection instead of orally as indicated and the subject had received two doses of ROTATEQ previously "with no problems". On 1 June 2012, less than one day after vaccination with PENTACEL, pneumococcal vaccines (Non-GSK) and ROTARIX, the subject experienced injection site redness and injection site soreness. The subject returned on 14 June 2012 and was administered ROTARIX orally and "no adverse side effects occurred". On 1 June 2012, the events were resolved. The healthcare professional explained that the vaccine was reconstituted correctly and a new needle and syringe were used to withdraw the vaccine from the vial and administer intramuscularly. The healthcare professional noted that the maladministration occurred because the nurse did not attend training in services or read given literature on ROTARIX. It was reported that six subjects were administered ROTARIX by intramuscular injection. See cases A0981435A, A0983047A, A0983050A, A0983052A, and A0983053A for details regarding the other five cases.
Age: 0.53
Sex: M
Vaccine: DTAPIPVHIB, PNC13, RV1, DTAPIPVHIB, PPV, RV1
Symptoms: Incorrect route of drug administration, Injection site erythema, Injection site pain, Interchange of vaccine products
Clinical narrative: This case was reported by a healthcare professional (nurse) and described the occurrence of injection site redness in a 6-month-old male subject who was vaccinated with ROTARIX (GlaxoSmithKline), PENTACEL and pneumococcal vaccines (non-gsk). Concurrent vaccination included rotavirus vaccine (non-gsk); non-GSK manufacturer; unknown given on an unspecified date. On 1 June 2012 the subject received a dose of ROTARIX (intramuscular, unknown) as the 3rd dose to complete ROTATEQ series, unspecified dose of PENTACEL (intramuscular, unknown), unspecified dose of pneumococcal vaccines (Non-GSK) (intramuscular, unknown) and experienced inappropriate route of vaccination with ROTARIX and interchange of vaccine products with ROTARIX. The ROTARIX was administered by intramuscular injection instead of orally as indicated and the subject had received two doses of ROTATEQ previously "with no problems". On 1 June 2012, less than one day after vaccination with PENTACEL, pneumococcal vaccines (Non-GSK) and ROTARIX, the subject experienced injection site redness and injection site soreness. The subject returned on 14 June 2012 and was administered ROTARIX orally and "no adverse side effects occurred". On 1 June 2012, the events were resolved. The healthcare professional explained that the vaccine was reconstituted correctly and a new needle and syringe were used to withdraw the vaccine from the vial and administer intramuscularly. The healthcare professional noted that the maladministration occurred because the nurse did not attend training in services or read given literature on ROTARIX. It was reported that six subjects were administered ROTARIX by intramuscular injection. See cases A0981435A, A0983047A, A0983050A, A0983052A, and A0983053A for details regarding the other five cases.
Age: 0.2
Sex: F
Vaccine: DTAPIPVHIB, HEP, PNC13, RV1, DTAPIPVHIB, HEP, PPV, RV1
Symptoms: Incorrect route of drug administration, No adverse event
Clinical narrative: This case was reported by a healthcare professional (nurse) and described the occurrence of injection site redness in a 2-month-old female subject who was vaccinated with ROTARIX (GlaxoSmithKline). Concurrent vaccination included DTaP-polio-Hib (non-gsk); non-GSK manufacturer;unknown;unknown given on 30 April 2012; Hep B vaccine recombinant; manufacturer unspecified;intramuscular;unknown given on 30 April 2012; pneumococcal vaccines (non-gsk); non-GSK manufacturer;intramuscular;unknown given on 30 April 2012. On 30 April 2012 the subject received 1st dose of ROTARIX (intramuscular, unknown) and experienced inappropriate route of vaccination. The ROTARIX was administered by intramuscular injection instead of orally as indicated. On 30 April 2012, less than one day after vaccination with ROTARIX, the subject experienced injection site redness and injection site soreness. According to the nurse, the subject was to come back to the office on an unspecified date for oral administration of ROTARIX. On 30 April 2012, the events were resolved. The healthcare professional explained that the vaccine was reconstituted correctly and a new needle and syringe were used to withdraw the vaccine from the vial and administer intramuscularly. The healthcare professional noted that the maladministration occurred because the nurse did not attend training in services or rend given literature on ROTARIX. It was reported that six subjects were administered ROTARIX by intramuscular injection. See cases A0981435A, A0983047A, A0983050A, A0983051A, and A0983053A for details regarding the other five cases.
Age: 0.2
Sex: F
Vaccine: DTAPIPVHIB, HEP, PNC13, RV1, DTAPIPVHIB, HEP, PPV, RV1
Symptoms: Incorrect route of drug administration, Injection site erythema, Injection site pain
Clinical narrative: This case was reported by a healthcare professional (nurse) and described the occurrence of injection site redness in a 2-month-old female subject who was vaccinated with ROTARIX (GlaxoSmithKline). Concurrent vaccination included DTaP-polio-Hib (non-gsk); non-GSK manufacturer;unknown;unknown given on 30 April 2012; Hep B vaccine recombinant; manufacturer unspecified;intramuscular;unknown given on 30 April 2012; pneumococcal vaccines (non-gsk); non-GSK manufacturer;intramuscular;unknown given on 30 April 2012. On 30 April 2012 the subject received 1st dose of ROTARIX (intramuscular, unknown) and experienced inappropriate route of vaccination. The ROTARIX was administered by intramuscular injection instead of orally as indicated. On 30 April 2012, less than one day after vaccination with ROTARIX, the subject experienced injection site redness and injection site soreness. According to the nurse, the subject was to come back to the office on an unspecified date for oral administration of ROTARIX. On 30 April 2012, the events were resolved. The healthcare professional explained that the vaccine was reconstituted correctly and a new needle and syringe were used to withdraw the vaccine from the vial and administer intramuscularly. The healthcare professional noted that the maladministration occurred because the nurse did not attend training in services or rend given literature on ROTARIX. It was reported that six subjects were administered ROTARIX by intramuscular injection. See cases A0981435A, A0983047A, A0983050A, A0983051A, and A0983053A for details regarding the other five cases.
Age: 0.33
Sex: M
Vaccine: DTAPIPVHIB, PNC13, RV1, DTAPIPVHIB, PPV, RV1
Symptoms: Incorrect route of drug administration, No adverse event
Clinical narrative: This case was reported by a healthcare professional (nurse) and described the occurrence of injection site redness in a 4-month-old male subject who was vaccinated with ROTARIX (GlaxoSmithKline). Concurrent medical conditions included kidney hydronephrosis. Concurrent vaccination included DTaP-polio-Hib (non-gsk); non-GSK manufacturer;unknown;unknown given on 4 June 2012; pneumococcal vaccines (non-gsk); non-GSK manufacturer;intramuscular;unknown given on 4 June 2012; rotavirus vaccine (non-gsk); non-GSK manufacturer;unknown given in 2012. On 4 June 2012 the subject received a dose of ROTARIX as the 2nd dose in series (intramuscular, unknown) and experienced inappropriate route of vaccination and interchange of vaccine products. The ROTARIX was administered by intramuscular injection instead of orally as indicated. The nurse stated that the subject had been given ROTATE! at 2 months of age. On 4 June 2012, less than one day after vaccination with ROTARIX, the subject experienced injection site redness and injection site soreness. The nurse noted that the events were "normal adverse side effects of any injection". The nurse reported that the subject returned to the office on 15 June 2012 and was administered ROTARIX orally and "no problems occurred". On 4 June 2012, the events were resolved. The healthcare professional explained that the vaccine was reconstituted correctly and a new needle and syringe were used to withdraw the vaccine from the vial and administer intramuscularly. The healthcare professional noted that the maladministration occurred because the nurse did not attend training in services or rend given literature on ROTARIX. It was reported that six subjects were administered ROTARIX by intramuscular injection. See cases A0981435A, A0983047A, A0983050A, A0983051A, and A0983052A for details regarding the other five cases.
Age: 0.33
Sex: M
Vaccine: DTAPIPVHIB, PNC13, RV1, DTAPIPVHIB, PPV, RV1
Symptoms: Incorrect route of drug administration, Injection site erythema, Injection site pain, Interchange of vaccine products
Clinical narrative: This case was reported by a healthcare professional (nurse) and described the occurrence of injection site redness in a 4-month-old male subject who was vaccinated with ROTARIX (GlaxoSmithKline). Concurrent medical conditions included kidney hydronephrosis. Concurrent vaccination included DTaP-polio-Hib (non-gsk); non-GSK manufacturer;unknown;unknown given on 4 June 2012; pneumococcal vaccines (non-gsk); non-GSK manufacturer;intramuscular;unknown given on 4 June 2012; rotavirus vaccine (non-gsk); non-GSK manufacturer;unknown given in 2012. On 4 June 2012 the subject received a dose of ROTARIX as the 2nd dose in series (intramuscular, unknown) and experienced inappropriate route of vaccination and interchange of vaccine products. The ROTARIX was administered by intramuscular injection instead of orally as indicated. The nurse stated that the subject had been given ROTATE! at 2 months of age. On 4 June 2012, less than one day after vaccination with ROTARIX, the subject experienced injection site redness and injection site soreness. The nurse noted that the events were "normal adverse side effects of any injection". The nurse reported that the subject returned to the office on 15 June 2012 and was administered ROTARIX orally and "no problems occurred". On 4 June 2012, the events were resolved. The healthcare professional explained that the vaccine was reconstituted correctly and a new needle and syringe were used to withdraw the vaccine from the vial and administer intramuscularly. The healthcare professional noted that the maladministration occurred because the nurse did not attend training in services or rend given literature on ROTARIX. It was reported that six subjects were administered ROTARIX by intramuscular injection. See cases A0981435A, A0983047A, A0983050A, A0983051A, and A0983052A for details regarding the other five cases.
Sex: F
Vaccine: TDAP, TDAP, TDAP, TDAP
Symptoms: Death neonatal, Maternal exposure during pregnancy, Neonatal disorder, Ultrasound antenatal screen normal
Clinical narrative: Initial report was received from a consumer, who was also the patient's mother, through another manufacturer on 04 September 2012 under reference number A0984491B. The mother case was captured in case number 2012-08092. A female neonate patient had received via a transplacental route a dose of ADACEL (lot number not reported) and a dose of BOOSTRIX, GlaxoSmithKline (lot number not reported) on 06 September 2011 during an unknown trimester. Examination results of an "ultrasound 7" showed no evidence of a defect. On 01 May 2012, at an unspecified gestation age, the neonate was delivered by unknown method and weighed 3.9 kilograms. Apgar score was not provided. The neonate was diagnosed with pulmonary hypertension and arterial venous malformation. The neonate remained hospitalized and died on 17 May 2012, cause of death was not provided. It was unknown whether an autopsy was performed. The outcome of pulmonary hypertension and arterial venous malformation were not specified. The outcome was fatal. Documents held by sender: None.
Sex: F
Vaccine: TDAP, TDAP, TDAP, TDAP
Symptoms: Arteriovenous malformation, Death neonatal, Foetal exposure during pregnancy, Neonatal disorder, Pulmonary hypertension
Clinical narrative: Initial report was received from a consumer, who was also the patient's mother, through another manufacturer on 04 September 2012 under reference number A0984491B. The mother case was captured in case number 2012-08092. A female neonate patient had received via a transplacental route a dose of ADACEL (lot number not reported) and a dose of BOOSTRIX, GlaxoSmithKline (lot number not reported) on 06 September 2011 during an unknown trimester. Examination results of an "ultrasound 7" showed no evidence of a defect. On 01 May 2012, at an unspecified gestation age, the neonate was delivered by unknown method and weighed 3.9 kilograms. Apgar score was not provided. The neonate was diagnosed with pulmonary hypertension and arterial venous malformation. The neonate remained hospitalized and died on 17 May 2012, cause of death was not provided. It was unknown whether an autopsy was performed. The outcome of pulmonary hypertension and arterial venous malformation were not specified. The outcome was fatal. Documents held by sender: None.
Age: 18.0
Sex: M
Vaccine: HPV4, MNQ, HPV4
Symptoms: Dizziness, Feeling abnormal
Clinical narrative: This spontaneous report as received from licensed practical nurse refers to a male patient of unknown age. On unknown dates, the patient was vaccinated with 3 doses of GARDASIL, 0.5ml, intramuscularly (lot number not reported) at 0, 2 months, 6 months. No other co-suspects were reported. No concomitant medications were reported. On an unknown date, the patient became light headed and fainted, his blood pressure dropped dramatically. The patient sought unspecified medical attention. As a treatment, the patient's blood was monitored in the office. At the time of report, the adverse events outcome was reported as recovered/resolved (date unspecified). The relatedness for the patient's events was not reported for GARDASIL. Additional information has been requested.
Age: 18.0
Sex: M
Vaccine: HPV4, MNQ, HPV4
Symptoms: Blood pressure decreased, Dizziness, Syncope
Clinical narrative: This spontaneous report as received from licensed practical nurse refers to a male patient of unknown age. On unknown dates, the patient was vaccinated with 3 doses of GARDASIL, 0.5ml, intramuscularly (lot number not reported) at 0, 2 months, 6 months. No other co-suspects were reported. No concomitant medications were reported. On an unknown date, the patient became light headed and fainted, his blood pressure dropped dramatically. The patient sought unspecified medical attention. As a treatment, the patient's blood was monitored in the office. At the time of report, the adverse events outcome was reported as recovered/resolved (date unspecified). The relatedness for the patient's events was not reported for GARDASIL. Additional information has been requested.
Age: 0.18
Sex: M
Vaccine: DTAPHEPBIP, HIBV, PNC13, RV1, DTAPHEPBIP, HIBV, PNC, RV1
Symptoms: Activated partial thromboplastin time, Diarrhoea, Diarrhoea haemorrhagic, Enema administration, Flatulence
Clinical narrative: Patient was admitted to hospital on 9/7/12 for intussusception. Was d/c on 9/9/12. Reduced surgery with air enema.
Age: 0.18
Sex: M
Vaccine: DTAPHEPBIP, HIBV, PNC13, RV1, DTAPHEPBIP, HIBV, PNC, RV1
Symptoms: Full blood count, Hypophagia, Intussusception, Irritability, Laboratory test
Clinical narrative: Patient was admitted to hospital on 9/7/12 for intussusception. Was d/c on 9/9/12. Reduced surgery with air enema.
Age: 0.18
Sex: M
Vaccine: DTAPHEPBIP, HIBV, PNC13, RV1, DTAPHEPBIP, HIBV, PNC, RV1
Symptoms: Prothrombin time, Pyrexia, Ultrasound abdomen abnormal, Urinary system X-ray, Urine output decreased
Clinical narrative: Patient was admitted to hospital on 9/7/12 for intussusception. Was d/c on 9/9/12. Reduced surgery with air enema.
Age: 0.18
Sex: M
Vaccine: DTAPHEPBIP, HIBV, PNC13, RV1, DTAPHEPBIP, HIBV, PNC, RV1
Symptoms: Viral upper respiratory tract infection, Vomiting
Clinical narrative: Patient was admitted to hospital on 9/7/12 for intussusception. Was d/c on 9/9/12. Reduced surgery with air enema.
Age: 0.18
Sex: M
Vaccine: DTAPHEPBIP, HIBV, PNC13, RV1, DTAPHEPBIP, HIBV, PNC, RV1
Symptoms: Enema administration, Intestinal operation, Intussusception
Clinical narrative: Patient was admitted to hospital on 9/7/12 for intussusception. Was d/c on 9/9/12. Reduced surgery with air enema.
Age: 28.0
Sex: F
Vaccine: FLUX
Symptoms: Fatigue, Injection site pain, Insomnia, Malaise, Neck pain
Clinical narrative: Dull pain at injection site, feeling of 'puffiness' and periodic tingling on Left side of face, left arm, and left hand. Itchiness left hand. Sore throat (mostly left side). Tiredness. Neck ache. General Malaise. Extreme thirst. Difficulty sleeping.
Age: 28.0
Sex: F
Vaccine: FLUX
Symptoms: Oropharyngeal pain, Paraesthesia, Pruritus, Swelling face, Thirst
Clinical narrative: Dull pain at injection site, feeling of 'puffiness' and periodic tingling on Left side of face, left arm, and left hand. Itchiness left hand. Sore throat (mostly left side). Tiredness. Neck ache. General Malaise. Extreme thirst. Difficulty sleeping.
Age: 21.0
Sex: F
Vaccine: FLU3
Symptoms: Aphonia, Cough, Headache, Malaise, Nasal congestion
Clinical narrative: Patient has received annual influenza vaccines recorded in electronic immunization records between 2008 and 2011, as well as the monovalent H1N1 flu vaccine in Dec 2009. Denies AEFI with vaccines until she received the Flu vaccine on 25 Aug 2011 (Sanofi Pasteur, # UH453AC). Patient reports developed of fever, (did not measure temperature and does not recall what her temperature was when she went on sick call), headaches (pain intensity rated as 4-5/10 using VAS), nasal congestion alternating with rhinorrhea, sore throat, and cough. Denies chest pain, shortness of breath, wheezing, and body aches. After 1 week, she lost her voice. Patient sought evaluation on sick call. Although not feeling well, she was able to function at work. Patient has a history of exercise induced asthma and allergic rhinitis, but denies symptoms exacerbation in temporal association to vaccine receipt. Denies exposure to sick contacts; reports neighbor experienced similar symptoms (sore throat, stuffy nose) within days of receiving her flu vaccine. Patient reports symptoms persisted for about 3 weeks.
Age: 21.0
Sex: F
Vaccine: FLU3
Symptoms: Oropharyngeal pain, Pyrexia, Rhinorrhoea
Clinical narrative: Patient has received annual influenza vaccines recorded in electronic immunization records between 2008 and 2011, as well as the monovalent H1N1 flu vaccine in Dec 2009. Denies AEFI with vaccines until she received the Flu vaccine on 25 Aug 2011 (Sanofi Pasteur, # UH453AC). Patient reports developed of fever, (did not measure temperature and does not recall what her temperature was when she went on sick call), headaches (pain intensity rated as 4-5/10 using VAS), nasal congestion alternating with rhinorrhea, sore throat, and cough. Denies chest pain, shortness of breath, wheezing, and body aches. After 1 week, she lost her voice. Patient sought evaluation on sick call. Although not feeling well, she was able to function at work. Patient has a history of exercise induced asthma and allergic rhinitis, but denies symptoms exacerbation in temporal association to vaccine receipt. Denies exposure to sick contacts; reports neighbor experienced similar symptoms (sore throat, stuffy nose) within days of receiving her flu vaccine. Patient reports symptoms persisted for about 3 weeks.
Age: 88.0
Sex: F
Vaccine: PPV, TDAP
Symptoms: Body temperature increased, Injected limb mobility decreased, Injection site pain, Insomnia, Local reaction
Clinical narrative: 88 y/o who developed right upper arm pain within 6 hours following receipt of Tdap and PNUEMOVAX vaccines in her right upper arm on 30 AUG 2012. Previous Td vaccine received on 27 JUN 2005 and previous pneumococcal vaccinations received on 26 NOV 2001 and 29 OCT 2007. Patient denies anything unusual about vaccine administration technique, and does not recall unusual pain during vaccine administration. Patient received vaccinations around 1030 on Thursday and by 1600, she experienced significant right upper arm and shoulder pain (8/10 on pain scale). The pain limited movement of her RUE; she drove home trying to use her left hand on the steering wheel. When she arrived home, she noted increased redness, swelling, and warmth surrounding vaccination sites (area about the size of a tennis ball). Patient denies any unusual or persistent bruising near vaccination sites. She took two TYLENOL 500 mg capsules before bed and tried applying CAPSAICIN to affected area, but still had difficulty sleeping due to the pain. In addition to pain and local reaction, patient was running a temperature of 100.1 on Friday and Saturday. On Friday, she felt her heart racing and she took ASA 400 mg. She attempted to call the clinic on Friday, 31 AUG, but due to training holiday, she was referred to the emergency room. She spoke to a nurse in the emergency room who recommended patient come in for evaluation, but patient declined. She was advised to apply warm, moist heat to the area and take TYLENOL as needed. (Patient reports she cannot take anti-inflammatories due to low platelet count). Patient followed advice and noted some improvement of right upper arm and shoulder pain by the following day; her heart rate returned to normal before bedtime on Friday. Patient had difficulty sleeping through the night Saturday and Sunday night due to pain. She noted increased pain with direct pressure to area and with movement of shoulder. (Patient reports history of right cuff tear). Patient denies weakness or numbness and tingling of upper extremities. She denies recent injury or trauma to right upper arm. Last p.m. patient took two TYLENOL 500 mg before bed and reports she was able to sleep through the night. Today her pain is minimal except with pressure to area and when holding arms at shoulder level in front of her. Patient was feeling well on the day of vaccine receipt. She denies any previous vaccine reactions. Patient denies any angioedema, rashes, respiratory, or GI symptoms.
Age: 88.0
Sex: F
Vaccine: PPV, TDAP
Symptoms: Palpitations, Vaccination site swelling, Vaccination site warmth
Clinical narrative: 88 y/o who developed right upper arm pain within 6 hours following receipt of Tdap and PNUEMOVAX vaccines in her right upper arm on 30 AUG 2012. Previous Td vaccine received on 27 JUN 2005 and previous pneumococcal vaccinations received on 26 NOV 2001 and 29 OCT 2007. Patient denies anything unusual about vaccine administration technique, and does not recall unusual pain during vaccine administration. Patient received vaccinations around 1030 on Thursday and by 1600, she experienced significant right upper arm and shoulder pain (8/10 on pain scale). The pain limited movement of her RUE; she drove home trying to use her left hand on the steering wheel. When she arrived home, she noted increased redness, swelling, and warmth surrounding vaccination sites (area about the size of a tennis ball). Patient denies any unusual or persistent bruising near vaccination sites. She took two TYLENOL 500 mg capsules before bed and tried applying CAPSAICIN to affected area, but still had difficulty sleeping due to the pain. In addition to pain and local reaction, patient was running a temperature of 100.1 on Friday and Saturday. On Friday, she felt her heart racing and she took ASA 400 mg. She attempted to call the clinic on Friday, 31 AUG, but due to training holiday, she was referred to the emergency room. She spoke to a nurse in the emergency room who recommended patient come in for evaluation, but patient declined. She was advised to apply warm, moist heat to the area and take TYLENOL as needed. (Patient reports she cannot take anti-inflammatories due to low platelet count). Patient followed advice and noted some improvement of right upper arm and shoulder pain by the following day; her heart rate returned to normal before bedtime on Friday. Patient had difficulty sleeping through the night Saturday and Sunday night due to pain. She noted increased pain with direct pressure to area and with movement of shoulder. (Patient reports history of right cuff tear). Patient denies weakness or numbness and tingling of upper extremities. She denies recent injury or trauma to right upper arm. Last p.m. patient took two TYLENOL 500 mg before bed and reports she was able to sleep through the night. Today her pain is minimal except with pressure to area and when holding arms at shoulder level in front of her. Patient was feeling well on the day of vaccine receipt. She denies any previous vaccine reactions. Patient denies any angioedema, rashes, respiratory, or GI symptoms.
Age: 15.0
Sex: M
Vaccine: HPV4, HPV4, HPV4
Symptoms: Confusional state, Influenza virus test, Neurological examination, Pyrexia, Seizure like phenomena
Clinical narrative: This spontaneous report as received from a physician refers to a 15 years old male patient with no medical history. The patient was vaccinated IM with a shot of GARDASIL (unspecified whether this was the first, second or third shot in the series, dose and lot # unknown) on 10-SEP-2012. No other co-suspects were reported. No concomitant medications were reported. In the evening of 10-SEP-2012, he had a fever of 99 degrees. He appeared to be confused and was sleep walking. The patient was seen in the office in the morning of 11-SEP-2012 and was treated with MOTRIN and TYLENOL. At this time, the physician noticed seizure like movements of the patient's arms. AEs were considered to be significantly disabling by the reporter. Test for influenza and other neurological test were run (unspecified). AE had improved but it was unknown if therapy was discontinued or not. Additional information has been requested.
Age: 15.0
Sex: M
Vaccine: HPV4, HPV4, HPV4
Symptoms: Somnambulism
Clinical narrative: This spontaneous report as received from a physician refers to a 15 years old male patient with no medical history. The patient was vaccinated IM with a shot of GARDASIL (unspecified whether this was the first, second or third shot in the series, dose and lot # unknown) on 10-SEP-2012. No other co-suspects were reported. No concomitant medications were reported. In the evening of 10-SEP-2012, he had a fever of 99 degrees. He appeared to be confused and was sleep walking. The patient was seen in the office in the morning of 11-SEP-2012 and was treated with MOTRIN and TYLENOL. At this time, the physician noticed seizure like movements of the patient's arms. AEs were considered to be significantly disabling by the reporter. Test for influenza and other neurological test were run (unspecified). AE had improved but it was unknown if therapy was discontinued or not. Additional information has been requested.
Age: 15.0
Sex: M
Vaccine: HPV4, HPV4, HPV4
Symptoms: Chills, Delirium, Influenza A virus test negative, Influenza B virus test, Influenza virus test negative
Clinical narrative: This spontaneous report as received from a physician refers to a 15 years old male patient with no medical history. The patient was vaccinated IM with a shot of GARDASIL (unspecified whether this was the first, second or third shot in the series, dose and lot # unknown) on 10-SEP-2012. No other co-suspects were reported. No concomitant medications were reported. In the evening of 10-SEP-2012, he had a fever of 99 degrees. He appeared to be confused and was sleep walking. The patient was seen in the office in the morning of 11-SEP-2012 and was treated with MOTRIN and TYLENOL. At this time, the physician noticed seizure like movements of the patient's arms. AEs were considered to be significantly disabling by the reporter. Test for influenza and other neurological test were run (unspecified). AE had improved but it was unknown if therapy was discontinued or not. Additional information has been requested.
Age: 15.0
Sex: M
Vaccine: HPV4, HPV4, HPV4
Symptoms: Pyrexia, Somnambulism, Tremor
Clinical narrative: This spontaneous report as received from a physician refers to a 15 years old male patient with no medical history. The patient was vaccinated IM with a shot of GARDASIL (unspecified whether this was the first, second or third shot in the series, dose and lot # unknown) on 10-SEP-2012. No other co-suspects were reported. No concomitant medications were reported. In the evening of 10-SEP-2012, he had a fever of 99 degrees. He appeared to be confused and was sleep walking. The patient was seen in the office in the morning of 11-SEP-2012 and was treated with MOTRIN and TYLENOL. At this time, the physician noticed seizure like movements of the patient's arms. AEs were considered to be significantly disabling by the reporter. Test for influenza and other neurological test were run (unspecified). AE had improved but it was unknown if therapy was discontinued or not. Additional information has been requested.
Age: 15.0
Sex: M
Vaccine: HPV4, HPV4, HPV4
Symptoms: Chills, Delirium, Dyskinesia, Pyrexia, Somnambulism
Clinical narrative: This spontaneous report as received from a physician refers to a 15 years old male patient with no medical history. The patient was vaccinated IM with a shot of GARDASIL (unspecified whether this was the first, second or third shot in the series, dose and lot # unknown) on 10-SEP-2012. No other co-suspects were reported. No concomitant medications were reported. In the evening of 10-SEP-2012, he had a fever of 99 degrees. He appeared to be confused and was sleep walking. The patient was seen in the office in the morning of 11-SEP-2012 and was treated with MOTRIN and TYLENOL. At this time, the physician noticed seizure like movements of the patient's arms. AEs were considered to be significantly disabling by the reporter. Test for influenza and other neurological test were run (unspecified). AE had improved but it was unknown if therapy was discontinued or not. Additional information has been requested.
Age: 74.0
Sex: M
Vaccine: FLU3
Symptoms: Chills, Dyspnoea, Headache, Hyperhidrosis, Nasal congestion
Clinical narrative: Stuffy nostrils, sneezing, chills & sweat, head pain, shortness of breath, body aches 2 day duration.
Age: 74.0
Sex: M
Vaccine: FLU3
Symptoms: Pain, Sneezing
Clinical narrative: Stuffy nostrils, sneezing, chills & sweat, head pain, shortness of breath, body aches 2 day duration.
Age: 1.8
Sex: M
Vaccine: PNC13
Symptoms: Rash, Rash scarlatiniform, Streptococcus test negative
Clinical narrative: This is a spontaneous report from a physician received from the Agency. Regulatory Authority report number (E2B) AT-BASGAGES-121801, linked to AT-BASGAGES-121799. A 21-months-old male patient received the first dose of PREVENAR 13 at 0.5 ml, single intramuscular on 15Jun2012, and the ENCEPUR, at 0.25 ml, single intramuscular on 15Jun2012. The patient medical history and the concomitant medications were not reported. The patient experienced scarlatiniform exanthema and exanthema in pharynx and sole of feet (medically significant), with no fever on 15Jun2012. The patient recovered from the event on unknown date. Lab data included Streptococcus identification test of the pharynx with negative result.
Sex: F
Vaccine: PNC13
Symptoms: Arthritis, Arthritis bacterial, Arthroscopic surgery, Bursal fluid accumulation, Culture negative
Clinical narrative: This is a Literature report. The full publication has been requested. To authors knowledge, only 1 case report of pseudoseptic arthritis associated with intra-articular injection of a pneumococcal polyvalent vaccine (PPV) has been published. To authors a presented here a second case in which a patient presented with swelling, pain, and erythema of the affected shoulder. A 59-year-old woman presented to the emergency department with a 3-day history of severe pain and decreased mobility of her left shoulder after receiving a PPV vaccination. Her clinical and laboratory workup was suspicious for septic arthritis; however, magnetic resonance imaging of the affected shoulder with and without contrast showed only a partial thickness tear of the rotator cuff, fluid in the subacromial/subdeltoid bursa, and subcutaneous edema without evidence of an abscess. Based on the clinical and laboratory data, she underwent arthroscopic debridement. There was inflammatory tissue throughout the shoulder but no obvious purulent material. She did well postoperatively with a supervised range of motion rehabilitation protocol. Her cultures remained negative. At 12 weeks, she was discharged from follow-up. To authors suspected that the vaccination was inadvertently injected into the glenohumeral joint directly through the rotator cuff given the lack of a full-thickness tear and the patient's thin body habitus, which could explain her aseptic inflammatory arthritis.
Sex: F
Vaccine: PNC13
Symptoms: Debridement, Drug administered at inappropriate site, Erythema, Joint effusion, Joint swelling
Clinical narrative: This is a Literature report. The full publication has been requested. To authors knowledge, only 1 case report of pseudoseptic arthritis associated with intra-articular injection of a pneumococcal polyvalent vaccine (PPV) has been published. To authors a presented here a second case in which a patient presented with swelling, pain, and erythema of the affected shoulder. A 59-year-old woman presented to the emergency department with a 3-day history of severe pain and decreased mobility of her left shoulder after receiving a PPV vaccination. Her clinical and laboratory workup was suspicious for septic arthritis; however, magnetic resonance imaging of the affected shoulder with and without contrast showed only a partial thickness tear of the rotator cuff, fluid in the subacromial/subdeltoid bursa, and subcutaneous edema without evidence of an abscess. Based on the clinical and laboratory data, she underwent arthroscopic debridement. There was inflammatory tissue throughout the shoulder but no obvious purulent material. She did well postoperatively with a supervised range of motion rehabilitation protocol. Her cultures remained negative. At 12 weeks, she was discharged from follow-up. To authors suspected that the vaccination was inadvertently injected into the glenohumeral joint directly through the rotator cuff given the lack of a full-thickness tear and the patient's thin body habitus, which could explain her aseptic inflammatory arthritis.
Sex: F
Vaccine: PNC13
Symptoms: Mobility decreased, Musculoskeletal pain, Nuclear magnetic resonance imaging abnormal, Rotator cuff syndrome, Skin oedema
Clinical narrative: This is a Literature report. The full publication has been requested. To authors knowledge, only 1 case report of pseudoseptic arthritis associated with intra-articular injection of a pneumococcal polyvalent vaccine (PPV) has been published. To authors a presented here a second case in which a patient presented with swelling, pain, and erythema of the affected shoulder. A 59-year-old woman presented to the emergency department with a 3-day history of severe pain and decreased mobility of her left shoulder after receiving a PPV vaccination. Her clinical and laboratory workup was suspicious for septic arthritis; however, magnetic resonance imaging of the affected shoulder with and without contrast showed only a partial thickness tear of the rotator cuff, fluid in the subacromial/subdeltoid bursa, and subcutaneous edema without evidence of an abscess. Based on the clinical and laboratory data, she underwent arthroscopic debridement. There was inflammatory tissue throughout the shoulder but no obvious purulent material. She did well postoperatively with a supervised range of motion rehabilitation protocol. Her cultures remained negative. At 12 weeks, she was discharged from follow-up. To authors suspected that the vaccination was inadvertently injected into the glenohumeral joint directly through the rotator cuff given the lack of a full-thickness tear and the patient's thin body habitus, which could explain her aseptic inflammatory arthritis.
Sex: F
Vaccine: PNC13
Symptoms: Soft tissue inflammation, Swelling
Clinical narrative: This is a Literature report. The full publication has been requested. To authors knowledge, only 1 case report of pseudoseptic arthritis associated with intra-articular injection of a pneumococcal polyvalent vaccine (PPV) has been published. To authors a presented here a second case in which a patient presented with swelling, pain, and erythema of the affected shoulder. A 59-year-old woman presented to the emergency department with a 3-day history of severe pain and decreased mobility of her left shoulder after receiving a PPV vaccination. Her clinical and laboratory workup was suspicious for septic arthritis; however, magnetic resonance imaging of the affected shoulder with and without contrast showed only a partial thickness tear of the rotator cuff, fluid in the subacromial/subdeltoid bursa, and subcutaneous edema without evidence of an abscess. Based on the clinical and laboratory data, she underwent arthroscopic debridement. There was inflammatory tissue throughout the shoulder but no obvious purulent material. She did well postoperatively with a supervised range of motion rehabilitation protocol. Her cultures remained negative. At 12 weeks, she was discharged from follow-up. To authors suspected that the vaccination was inadvertently injected into the glenohumeral joint directly through the rotator cuff given the lack of a full-thickness tear and the patient's thin body habitus, which could explain her aseptic inflammatory arthritis.
Age: 79.0
Sex: F
Vaccine: PNC13
Symptoms: Asthenia, Chills, Heart rate increased, Injection site pain, Injection site warmth
Clinical narrative: This is a spontaneous report obtained from a contactable Other Health Professional. And the subsequent information is from a contactable physician. A 79 year old female patient received PREVNAR 13 (lot# F45137, expiration date: 31Mar2014) on 16Aug2012 at a dose of 0.5 ml IM in left arm. Relevant medical history included type 2 diabetes and hypertension (both ongoing). The patient neither received any other vaccine on 16Aug2012 nor four weeks prior to that along with PREVNAR 13. Relevant concomitant medication included metformin 850 mg two times a day for type 2 diabetes, amlodipine at 10 mg daily for hypertension, chlorthalidone tablet at half tablet of 25 mg daily for hypertension, simvastatin at 20 mg daily at bed time for an unknown indication and potassium at 20 mEq daily as supplement, all since an unknown duration. On 16Aug2012, after receiving PREVNAR 13, the patient had a severe reaction, had high fever of 102 degrees, had chills, she was very weak and her arm was swollen, rapid Pulse 120/min, local large inoculation (tender and hot). The patient was admitted to hospital. Relevant laboratory tests were unknown. The therapeutic measures taken for severe reaction included ATARAX at 25 mg two times a day and cimetidine at 800 mg two times a day. The therapeutic measures taken for other reported events were unknown. At the time of the report, the patient was recovering from the reported events. The reporter considered there was a reasonable possibility that the event fever was related to PREVNAR 13. Follow-up (10Sep2012): New information reported from a contactable physician includes: patient age, vaccination details (route, date, expiration date and lot #), onset date and outcome of events, additional events (rapid Pulse 120/min, local large inoculation), seriousness (admitted to hospital) and causality assessment for the reported event (fever was related to PREVNAR 13). Follow-up attempts completed. No further information expected.
Age: 79.0
Sex: F
Vaccine: PNC13
Symptoms: Oedema peripheral, Pyrexia
Clinical narrative: This is a spontaneous report obtained from a contactable Other Health Professional. And the subsequent information is from a contactable physician. A 79 year old female patient received PREVNAR 13 (lot# F45137, expiration date: 31Mar2014) on 16Aug2012 at a dose of 0.5 ml IM in left arm. Relevant medical history included type 2 diabetes and hypertension (both ongoing). The patient neither received any other vaccine on 16Aug2012 nor four weeks prior to that along with PREVNAR 13. Relevant concomitant medication included metformin 850 mg two times a day for type 2 diabetes, amlodipine at 10 mg daily for hypertension, chlorthalidone tablet at half tablet of 25 mg daily for hypertension, simvastatin at 20 mg daily at bed time for an unknown indication and potassium at 20 mEq daily as supplement, all since an unknown duration. On 16Aug2012, after receiving PREVNAR 13, the patient had a severe reaction, had high fever of 102 degrees, had chills, she was very weak and her arm was swollen, rapid Pulse 120/min, local large inoculation (tender and hot). The patient was admitted to hospital. Relevant laboratory tests were unknown. The therapeutic measures taken for severe reaction included ATARAX at 25 mg two times a day and cimetidine at 800 mg two times a day. The therapeutic measures taken for other reported events were unknown. At the time of the report, the patient was recovering from the reported events. The reporter considered there was a reasonable possibility that the event fever was related to PREVNAR 13. Follow-up (10Sep2012): New information reported from a contactable physician includes: patient age, vaccination details (route, date, expiration date and lot #), onset date and outcome of events, additional events (rapid Pulse 120/min, local large inoculation), seriousness (admitted to hospital) and causality assessment for the reported event (fever was related to PREVNAR 13). Follow-up attempts completed. No further information expected.
Sex: M
Vaccine: MEN
Symptoms: Bacterial test positive, Meningitis meningococcal, Neisseria test positive, Polymerase chain reaction, Vaccination failure
Clinical narrative: Initial report was retrieved from the scientific literature on 06 September 2012. The following information is verbatim from the abstract: "Meningococci have historically caused extensive illness among members. Three successive meningococcal vaccine types were used from 1971 through 2010; overall disease incidence dropped by >90% during this period. During 2006-2010, disease incidence of 0.38 (cases per 100,000 person-years) among members was not significantly different from the incidence of 0.26 among the age-matched general population. Of the 26 cases, 5 were fatal, 15 were vaccine failures (e.g., illness in a person who had been vaccinated), and 9 were caused by Neisseria meningitidis serogroup Y. Incidences among 17- to 19-year-old were significantly higher than among comparison populations (p<0.05). No apparent change in epidemiology of meningococcal disease was observed after replacement of quadrivalent polysaccharide vaccine with conjugate vaccine in 2007. The data demonstrate that vaccination with meningococcal vaccine is effective." According to the report, the cases were confirmed by culture, PCR or both. The information included in this case concerns a 20-24-year-old male patient who had received MENOMUNE A/C/Y/W-135 (lot number, route, site and date of administration not reported) and an unspecified amount of time after vaccination developed meningococcal meningitis, year reported as 2006 (Q 3). Neisseria meningitidis serogroup for this case was unknown. Treatments were not reported. No further information was available at the time of report. Death was reported as "No", however the patient's outcome was not reported. The reporter for this case is the same as for cases 2012-08240, -08241, -08242, -08243, -08244, -08245, -08246, -08247, -08248, -08249, -08250, -08251, -08252, -08253, -08254 and -08255. Documents held by sender: None.
Sex: M
Vaccine: MNQ
Symptoms: Bacterial test positive, Meningitis meningococcal, Neisseria test positive, Polymerase chain reaction
Clinical narrative: Initial report was retrieved from the scientific literature on 06 September 2012. The following information is verbatim from the abstract: "Meningococci have historically caused extensive illness among members. Three successive meningococcal vaccine types were used from 1971 through 2010; overall disease incidence dropped by >90% during this period. During 2006-2010, disease incidence of 0.38 (cases per 100,000 person-years) among members was not significantly different from the incidence of 0.26 among the age-matched general population. Of the 26 cases, 5 were fatal, 15 were vaccine failures (e.g., illness in a person who had been vaccinated), and 9 were caused by Neisseria meningitidis serogroup Y. Incidences among 17- to 19-year old trainees and among others were significantly higher than among comparison populations (p<0.05). No apparent change in epidemiology of meningococcal disease was observed after replacement of quadrivalent polysaccharide vaccine with conjugate vaccine in 2007. The data demonstrate that vaccination with meningococcal vaccine is effective." According to the report, the cases were confirmed by culture, PCR or both. The information included in this case concerns a 17-19-year-old male patient who had received MENACTRA (lot number, route, site and date of administration not reported) and 9 months after vaccination developed meningococcal meningitis, year reported as 2008 (Q 2). Neisseria meningitidis serogroup was unknown for this case. Treatments were not reported. No further information was available at the time of report. Death was reported as "No", however the patient's outcome was not reported. The reporter for this case is the same as for cases 2012-08240, -08241, -08242, -08243, -08244, -08245, -08246, -08247, -08248, -08249, -08250, -08251, -08252, -08253, -08254, and -08256. Documents held by sender: None.
Sex: F
Vaccine: MEN
Symptoms: Bacterial test positive, Meningitis meningococcal, Meningococcal sepsis, Neisseria test positive, Polymerase chain reaction
Clinical narrative: Initial report was retrieved from the scientific literature on 06 September 2012. The following information is verbatim from the abstract: "Meningococci have historically caused extensive illness among members. Three successive meningococcal vaccine types were used from 1971 through 2010; overall disease incidence dropped by >90% during this period. During 2006-2010, disease incidence of 0.38 (cases per 100,000 person-years) among members was not significantly different from the incidence of 0.26 among the age-matched general population. Of the 26 cases, 5 were fatal, 15 were vaccine failures (e.g., illness in a person who had been vaccinated), and 9 were caused by Neisseria meningitidis serogroup Y. Incidences among 17- to 19-year-old were significantly higher than among comparison populations (p<0.05). No apparent change in epidemiology of meningococcal disease was observed after replacement of quadrivalent polysaccharide vaccine with conjugate vaccine in 2007. The data demonstrate that vaccination with meningococcal vaccine is effective." According to the report, the cases were confirmed by culture, PCR or both. The information included in this case concerns a 20-24 year-old female patient who had received MENOMUNE A/C/Y/W-135 (lot number, route, site and date of administration not reported) and 43 months after vaccination developed meningitis and sepsis, year reported as 2010 (Q 2). Neisseria meningitidis serogroup was determined to be serogroup Y. Treatments were not reported. No further information was available at the time of report. Death was reported as "No", however the patient's outcome was not reported. The reporter for this case is the same as for cases 2012-08240, -08241, -08242, -08243, -08244, -08245, -08246, -08247, -08248, -08249, -08250, -08252, -08253, -08254, -08255, and -08256. Documents held by sender: None.