chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 78.0
Sex: F
Vaccine: FLU3
Symptoms: Activities of daily living impaired, Chronic obstructive pulmonary disease, Condition aggravated, Death, Herpes zoster
Clinical narrative: Case number PHHY2011US114552 is a spontaneous case received initially from Vaccine Adverse Event Reporting System (VAERS Ref: 414136) website on 01 Mar 2011 with follow-up internal review on 11 Jan 2012 of the data received on 01 Mar 2011 and follow up information received from the quality assurance department on 06 Jan 2012, with another follow-up received from the quality assurance department (reference number: 140395) on 02 Apr 2012: This report refers to a 78 year old female patient. This polymedicated patient had a medical history of COPD. She was vaccinated with shingles vaccine (batch number and trade name not reported) on 15 Jul 2009. She was vaccinated with FLUVIRIN (batch number: 97846P2A) intramuscularly in the left arm on 14 Sep 2009. She developed a very intense case of shingles and developed severe neuropathy in her left leg and abdomen on 01 May 2010. She was hospitalized for about 6 weeks and had to move to assisted living. The events were reported as serious (disability). The patient never recovered. The shingles amplified her COPD. The patient died due to the amplified COPD on 26 Oct 2010. A quality investigation pertaining to this case had been registered with reference number 140395. Based on the document review, it was stated that the concerned FLUVIRIN batch number 97846P2A was manufactured in accordance with approved internal procedures and were in compliance with the current good manufacturing practices (cGMP) requirements. Non significant follow up information received from the quality assurance department on 06 Jan 2012: updated only the quality reference number. Following internal review on 11 Jan 2012 of the data received on 01 Mar 2011, it was found that the initial manufacturer receipt date was wrongly captured as 30 Dec 2011 instead of 01 Mar 2011. Follow-up received from the quality assurance department (reference number: 140395) on 02 Apr 2012: Updated batch review report.
Age: 78.0
Sex: F
Vaccine: FLU3
Symptoms: Neuropathy peripheral
Clinical narrative: Case number PHHY2011US114552 is a spontaneous case received initially from Vaccine Adverse Event Reporting System (VAERS Ref: 414136) website on 01 Mar 2011 with follow-up internal review on 11 Jan 2012 of the data received on 01 Mar 2011 and follow up information received from the quality assurance department on 06 Jan 2012, with another follow-up received from the quality assurance department (reference number: 140395) on 02 Apr 2012: This report refers to a 78 year old female patient. This polymedicated patient had a medical history of COPD. She was vaccinated with shingles vaccine (batch number and trade name not reported) on 15 Jul 2009. She was vaccinated with FLUVIRIN (batch number: 97846P2A) intramuscularly in the left arm on 14 Sep 2009. She developed a very intense case of shingles and developed severe neuropathy in her left leg and abdomen on 01 May 2010. She was hospitalized for about 6 weeks and had to move to assisted living. The events were reported as serious (disability). The patient never recovered. The shingles amplified her COPD. The patient died due to the amplified COPD on 26 Oct 2010. A quality investigation pertaining to this case had been registered with reference number 140395. Based on the document review, it was stated that the concerned FLUVIRIN batch number 97846P2A was manufactured in accordance with approved internal procedures and were in compliance with the current good manufacturing practices (cGMP) requirements. Non significant follow up information received from the quality assurance department on 06 Jan 2012: updated only the quality reference number. Following internal review on 11 Jan 2012 of the data received on 01 Mar 2011, it was found that the initial manufacturer receipt date was wrongly captured as 30 Dec 2011 instead of 01 Mar 2011. Follow-up received from the quality assurance department (reference number: 140395) on 02 Apr 2012: Updated batch review report.
Age: 0.5
Sex: F
Vaccine: DTAPHEPBIP, HIBV, PNC13, RV5
Symptoms: Explorative laparotomy, Gastrointestinal stoma complication, Ileostomy, Intensive care, Intestinal ischaemia
Clinical narrative: Initial report received on 30 June 2011 from another manufacturer, report #WAES1106USA03181. The initial reporter to this manufacturer had been a health care professional. Verbatim from the report: "This report was identified from a line listing obtained on request by the Company from the FDA under the Freedom of Information Act. A 6 month old (age "0.5") female with no illness at vaccination and a history of colonic distension and inability to stool spontaneously requiring ileostomy in November 2010 and a prolapse of ileostomy and revision of ileostomy in January and March 2011 who on 01 April 2011 was vaccinated with the second dose of ROTATEQ (lot#669073/1525A) by mouth. Second suspect therapy included the third dose of PREVNAR 13 (lot#912555) IM into the right leg, the third dose of ACTHIB (lot#UH255AA) IM into the right leg and PEDIARIX (lot#AC21B277AA) IM into the left leg. It was reported that the patient received the same vaccines on 25 January 2011, followed by the first and second ileostomy repair and resection procedures. On 14 April 2011 the patient experienced prolapsed ileostomy. The patient went to operation room (OR) and was noted to have intussuscepted 18 cm small bowel. 36 cm had to be resected and ileostomy was revised. Hospital record indicated the patient was diagnosed with prolapsed ileostomy, status post exploration laparotomy with bowel resection and revision of end ileostomy. The patient was irritable and fussy; 3 inches prolapsed bowel was noted at ostomy and patient was taken to emergency room (ER). The patient had 3 episodes of no bloody/nonbilious vomiting in ER and 15 cm prolapse with venous congestion. Patient was admitted. Reduction attempts at bedside were unsuccessful. The patient was taken to OR for exploratory laparotomy, ostomy revision and removal of 36 cm ischemic ileum. The patient was kept in PICU 4 days, then to floor and was discharged to home. The listing indicated that one or more of the events required hospitalization. The original reporting source was not provided. The VAERS ID# is 421158. No further information is available." It is noted that the Sanofi Pasteur SA lot number for ACTHIB is E1022-1. Documents held by sender: None.
Age: 0.5
Sex: F
Vaccine: DTAPHEPBIP, HIBV, PNC13, RV5
Symptoms: Intestinal prolapse, Intussusception, Irritability, Small intestinal resection, Vomiting
Clinical narrative: Initial report received on 30 June 2011 from another manufacturer, report #WAES1106USA03181. The initial reporter to this manufacturer had been a health care professional. Verbatim from the report: "This report was identified from a line listing obtained on request by the Company from the FDA under the Freedom of Information Act. A 6 month old (age "0.5") female with no illness at vaccination and a history of colonic distension and inability to stool spontaneously requiring ileostomy in November 2010 and a prolapse of ileostomy and revision of ileostomy in January and March 2011 who on 01 April 2011 was vaccinated with the second dose of ROTATEQ (lot#669073/1525A) by mouth. Second suspect therapy included the third dose of PREVNAR 13 (lot#912555) IM into the right leg, the third dose of ACTHIB (lot#UH255AA) IM into the right leg and PEDIARIX (lot#AC21B277AA) IM into the left leg. It was reported that the patient received the same vaccines on 25 January 2011, followed by the first and second ileostomy repair and resection procedures. On 14 April 2011 the patient experienced prolapsed ileostomy. The patient went to operation room (OR) and was noted to have intussuscepted 18 cm small bowel. 36 cm had to be resected and ileostomy was revised. Hospital record indicated the patient was diagnosed with prolapsed ileostomy, status post exploration laparotomy with bowel resection and revision of end ileostomy. The patient was irritable and fussy; 3 inches prolapsed bowel was noted at ostomy and patient was taken to emergency room (ER). The patient had 3 episodes of no bloody/nonbilious vomiting in ER and 15 cm prolapse with venous congestion. Patient was admitted. Reduction attempts at bedside were unsuccessful. The patient was taken to OR for exploratory laparotomy, ostomy revision and removal of 36 cm ischemic ileum. The patient was kept in PICU 4 days, then to floor and was discharged to home. The listing indicated that one or more of the events required hospitalization. The original reporting source was not provided. The VAERS ID# is 421158. No further information is available." It is noted that the Sanofi Pasteur SA lot number for ACTHIB is E1022-1. Documents held by sender: None.
Age: 0.23
Sex: F
Vaccine: RV5
Symptoms: Condition aggravated, Crying, Flatulence, Gastrooesophageal reflux disease, Infantile colic
Clinical narrative: Information has been received from a nurse concerning a 12 week old female with no pertinent medical history and no drug reactions or allergies who in April 2011, was vaccinated orally with a 2mls dose of ROTATEQ (lot # 668124/0520Z exp 31-MAR-2012). There was no concomitant medication. On 13-APR-2011 the patient's mother reported that her baby "was crying more and had had a lot of flatus" after being administered ROTATEQ. The patient sought medical attention by office visit and was treated with ranitidine. Nurse reported that patient would be getting "a complete blood cell count (CBC), Basic Metabolic Panel (BMP) and testing the feces as well as an abdominal x-ray today." At the time of the report, the patient had not recovered and was getting worse. Information has been received from medical records concerning a 12 week old female (also reported as 7 month old) with no known allergies. It was reported that the patient was administered the first dose of oral ROTATEQ on 11-Apr-2011. On 16-May-2011 the patient accompanied by her mother was seen for an acute care visit for reflux and gas issues. The patient experienced crying and flatulence. The patient's past medical history and active problems included: constipation, esophageal reflux, fever, fussy infant, immunization delinquent (unspecified), respiratory distress of newborn. The patient had a family history of asthma (mother and sister). Current medication included was ranitidine. The patient was feeding every two hours both breast and formula. The mother increased ranitidine dose with no help. The patient only gained three ounces during the last month. The patient's weight was listed as 12.25 lb. The physician reported the patient was fuss and seemed to be feeding well (breast and soy), but still had colic-like problems. The patient's bowel movements were of normal consistency twice a week. The patient was on ZANTAC for reflux and had been on MYLICON without success. Assessment included: esophageal reflux, infantile colic/ fussy infant. The treatment plan included: switching to NUTRAMIGEN from soy, to continue breast feeding and discontinue ranitidine and PREVACID. Additional information has been requested.
Age: 0.23
Sex: F
Vaccine: RV5
Symptoms: Irritability, Weight gain poor
Clinical narrative: Information has been received from a nurse concerning a 12 week old female with no pertinent medical history and no drug reactions or allergies who in April 2011, was vaccinated orally with a 2mls dose of ROTATEQ (lot # 668124/0520Z exp 31-MAR-2012). There was no concomitant medication. On 13-APR-2011 the patient's mother reported that her baby "was crying more and had had a lot of flatus" after being administered ROTATEQ. The patient sought medical attention by office visit and was treated with ranitidine. Nurse reported that patient would be getting "a complete blood cell count (CBC), Basic Metabolic Panel (BMP) and testing the feces as well as an abdominal x-ray today." At the time of the report, the patient had not recovered and was getting worse. Information has been received from medical records concerning a 12 week old female (also reported as 7 month old) with no known allergies. It was reported that the patient was administered the first dose of oral ROTATEQ on 11-Apr-2011. On 16-May-2011 the patient accompanied by her mother was seen for an acute care visit for reflux and gas issues. The patient experienced crying and flatulence. The patient's past medical history and active problems included: constipation, esophageal reflux, fever, fussy infant, immunization delinquent (unspecified), respiratory distress of newborn. The patient had a family history of asthma (mother and sister). Current medication included was ranitidine. The patient was feeding every two hours both breast and formula. The mother increased ranitidine dose with no help. The patient only gained three ounces during the last month. The patient's weight was listed as 12.25 lb. The physician reported the patient was fuss and seemed to be feeding well (breast and soy), but still had colic-like problems. The patient's bowel movements were of normal consistency twice a week. The patient was on ZANTAC for reflux and had been on MYLICON without success. Assessment included: esophageal reflux, infantile colic/ fussy infant. The treatment plan included: switching to NUTRAMIGEN from soy, to continue breast feeding and discontinue ranitidine and PREVACID. Additional information has been requested.
Age: 63.0
Sex: F
Vaccine: FLU(H1N1)
Symptoms: Abasia, Arthralgia, Disability, Rheumatoid arthritis, Vaccination complication
Clinical narrative: Case number PHHY2011US94936 is an initial spontaneous report received from Vaccine Adverse Event Reporting System (VAERS Ref: 424866) website on 27 Oct 2011 with a follow-up received from the quality assurance department (reference number: 134018) on 02 Apr 2012: This report refers to a 63 year old female patient. She was vaccinated with S-OIV FLUVIRIN (batch number: unknown) on 23 Nov 2009. Weeks after the vaccination, the patient experienced joint pains in hands at first, then progressively much worsened all over the body by 20 Mar 2011. In a period of 8 months (Mar 2011 to Nov 2011) the symptoms worsened and the patient developed inability to walk. Finally the patient was diagnosed with full blown rheumatoid arthritis and drugs were prescribed (unspecified). The event was reported as serious (disability) and was suspected to be related to S-OIV FLUVIRIN. Based on the document review, it was stated that all the batches for S-OIV FLUVIRIN were manufactured in accordance with approved internal procedures and were in compliance with the current good manufacturing practices (cGMP) requirements. It was unlikely that the cause of the reported adverse event would be as a result of any abnormal occurrence during the manufacture of the batch. Follow-up received from the quality assurance department (reference number: 134018) on 02 Apr 2012: Updated batch review report.
Age: 33.0
Sex: F
Vaccine: ANTH, TDAP, TYP, ANTH, TDAP, TYP
Symptoms: Artificial rupture of membranes, Delivery, Human chorionic gonadotropin positive, Live birth, Maternal exposure during pregnancy
Clinical narrative: On 5 APR 2012, SVD complicated by moderate meconium on AROM. Delivered Infant Baby Boy - Birth weight: 3.7 kg. APGARs 9/9 at 1 and 5 min respectively, and spontaneous cry at perineum upon delivery.
Age: 33.0
Sex: F
Vaccine: ANTH, TDAP, TYP, ANTH, TDAP, TYP
Symptoms: Meconium stain
Clinical narrative: On 5 APR 2012, SVD complicated by moderate meconium on AROM. Delivered Infant Baby Boy - Birth weight: 3.7 kg. APGARs 9/9 at 1 and 5 min respectively, and spontaneous cry at perineum upon delivery.
Age: 33.0
Sex: F
Vaccine: ANTH, TDAP, TYP, ANTH, TDAP, TYP
Symptoms: Artificial rupture of membranes, Delivery, Human chorionic gonadotropin positive, Hyperemesis gravidarum, Live birth
Clinical narrative: On 5 APR 2012, SVD complicated by moderate meconium on AROM. Delivered Infant Baby Boy - Birth weight: 3.7 kg. APGARs 9/9 at 1 and 5 min respectively, and spontaneous cry at perineum upon delivery.
Age: 33.0
Sex: F
Vaccine: ANTH, TDAP, TYP, ANTH, TDAP, TYP
Symptoms: Maternal exposure during pregnancy, Meconium in amniotic fluid, Ultrasound antenatal screen normal
Clinical narrative: On 5 APR 2012, SVD complicated by moderate meconium on AROM. Delivered Infant Baby Boy - Birth weight: 3.7 kg. APGARs 9/9 at 1 and 5 min respectively, and spontaneous cry at perineum upon delivery.
Age: 38.0
Sex: F
Vaccine: FLU3, PPV
Symptoms: Injection site warmth, Lymphadenopathy, Malaise, Protein urine present, Serum sickness
Clinical narrative: Case number PHHY2011US114271 is an initial spontaneous report received from vaccine adverse event reporting system (VAERS reference number: 437091) website on 30 Dec 2011 with the follow-up received from Quality assurance department (reference number: 140795) on 10 Jan 2012 and a follow up information received on 02 Apr 2012. This report refers to a 38-year-old female patient. Her medical history included asthma and concomitant medications were not reported. She was vaccinated with FLUVIRIN (batch number: 1100101) intramuscularly on to right arm and pneumococcal polysaccharide vaccine (other manufacturer, batch number: 1111Z) intramuscularly on to left arm on 24 Sep 2011. On 25 Sep 2011, she experienced felt warm in the left arm in pneumococcal polysaccharide vaccine injection site. The next day she felt sick. She went to doctor on 29 Sep 2011 and was diagnosed with serum sickness. She was given prednisone and hydrocodone/APAP, BENADRYL and aspirin and was sent to emergency room on 30 Sep 2011. She was also given as treatment, PERCOCET. On an unspecified date, her underarm lymph node enlarged and became the size of an apple and she experienced protein in kidneys. The final outcome was reported as condition unchanged on the day of reporting, 06 Oct 2011. The quality assurance department opened a complaint for this case was reference number 140795. Based on the documents review, it was stated that the concerned FLUVIRIN batch number 1100101 was manufactured in accordance with the approved internal procedures and it was in compliance with the current good manufacturing practices (cGMP) requirements. Non-significant follow-up received from Quality assurance department on 10 Jan 2012: Updated Quality complaint number. Follow up received from the quality assurance department (reference number: 140795) on 02 Apr 2012. Batch review report updated.
Age: 52.0
Sex: F
Vaccine: FLU3
Symptoms: Injection site erythema, Injection site pain, Staphylococcal infection
Clinical narrative: Case number PHHY2011US114175 is an initial spontaneous report received from vaccine adverse event reporting system (VAERS reference number: 439393) website on 30 Dec 2011 with a follow-up received from the quality assurance department (reference number: 140962) on 11 Jan 2012 with a follow up received on 02 Apr 2012. This report refers to a 52-year-old female patient. Her medical history and concomitant medications were not reported. She was vaccinated with FLUVIRIN (batch number: 11131P) injection on to left arm on 10 Oct 2011. On 19 Oct 2011, she reported that her arm was sore and red near injection site. The patient was seen by primary care provider (PCP) next day and was diagnosed to have Staphylococcal infection. She did not visit emergency room. She was given antibiotics for 5 days. The final outcome was reported as condition unchanged. Based on the documents review, it was stated that the concerned FLUVIRIN batch number 11131P was manufactured in accordance with the approved internal procedures and it was in compliance with the current good manufacturing practices (cGMP) requirements. Non significant follow-up received from the quality assurance department (reference number: 140962) on 11 Jan 2012: Updated reference number. Follow up received from the quality assurance department on 02 Apr 2012. Batch review report updated.
Age: 73.0
Sex: F
Vaccine: FLU3, PPV
Symptoms: Cellulitis, Contusion, Nausea, Pain, Rash
Clinical narrative: Case number PHHY2011US114393 is an initial spontaneous report received from Vaccine Adverse Event Reporting System (VAERS: 440220) website on 30 Dec 2011 with the follow-up received from Quality assurance department (reference number: 140743) on 10 Jan 2012 with another follow-up received the quality assurance department (reference number: 140743) on 02 Apr 2012: This report refers to 73 year old female patient. The patient was vaccinated with FLUVIRIN (batch number: 1101001) intramuscularly in the left arm and PPV (batch number: 0895AA, manufactured by Merck & CO) intramuscularly in the left arm on 17 Sep 2011. On an unspecified date, the patient experienced rash from elbow to shoulder, nausea, vomiting, pain and bruising. She was diagnosed with cellulitis. She visited the emergency room. The outcome of the event was reported as complete recovery. Based on the document review, it was stated that the concerned FLUVIRIN batch number 1101001 was manufactured in accordance with approved internal procedures and were in compliance with the current good manufacturing practices (cGMP) requirements. Non-significant follow-up received from Quality assurance department on 10 Jan 2012: Updated Quality complaint number. Follow-up received from the quality assurance department (reference number: 140743) on 02 Apr 2012: Updated batch review report.
Age: 73.0
Sex: F
Vaccine: FLU3, PPV
Symptoms: Vomiting
Clinical narrative: Case number PHHY2011US114393 is an initial spontaneous report received from Vaccine Adverse Event Reporting System (VAERS: 440220) website on 30 Dec 2011 with the follow-up received from Quality assurance department (reference number: 140743) on 10 Jan 2012 with another follow-up received the quality assurance department (reference number: 140743) on 02 Apr 2012: This report refers to 73 year old female patient. The patient was vaccinated with FLUVIRIN (batch number: 1101001) intramuscularly in the left arm and PPV (batch number: 0895AA, manufactured by Merck & CO) intramuscularly in the left arm on 17 Sep 2011. On an unspecified date, the patient experienced rash from elbow to shoulder, nausea, vomiting, pain and bruising. She was diagnosed with cellulitis. She visited the emergency room. The outcome of the event was reported as complete recovery. Based on the document review, it was stated that the concerned FLUVIRIN batch number 1101001 was manufactured in accordance with approved internal procedures and were in compliance with the current good manufacturing practices (cGMP) requirements. Non-significant follow-up received from Quality assurance department on 10 Jan 2012: Updated Quality complaint number. Follow-up received from the quality assurance department (reference number: 140743) on 02 Apr 2012: Updated batch review report.
Age: 0.19
Sex: F
Vaccine: RV5
Symptoms: Dermatitis diaper, Diarrhoea, Occult blood negative, Oral candidiasis
Clinical narrative: Information has been received from a health care worker concerning a 10 week old female patient with no drug reactions/allergies, no medical history who on 19-SEP-2011 was vaccinated with a first dose of ROTATEQ (lot # 669992/0287AA). There was no concomitant medication. On 21-SEP-2011, the patient experienced severe diarrhea, diaper rash and oral thrush after administration of her first dose of ROTATEQ. No treatment was provided for AE. Hemoccult was negative. Patient sought medical attention via office on 23-SEP-2011. Patient was examined on 29-SEP-2011 and patient was completed recovered. Healthcare worker did not know if the patient was hospitalized, life threatening, or significant disability. Patient did not die. Adverse event was not cancer or overdose. Follow up information had been received from the medical assistant concerning the female patient who on 19-SEP-2011 AM was vaccinated with a first dose of ROTATEQ (lot # 669992/0287AA) orally. On 21-SEP-2011, within 48 hours after receiving the vaccine, the patient experienced severe diarrhea which lasted more than 1 week. The patient sought medical attention via doctor visit. The patient had to try different formulas, now on "neutrmegen". Hemoccult was performed which showed negative. The patient had almost recovered. Additional information has been requested.
Age: 34.0
Sex: F
Vaccine: FLU3
Symptoms: Injection site erythema
Clinical narrative: Case number PHHY2012US010044 is a spontaneous report initially received from vaccine adverse event reporting system (VAERS reference number: 442541) website on 07 Feb 2012 with a follow-up received from the quality assurance department (reference number: 146125) on 02 Apr 2012: This report refers to a 34-year-old female patient. Her medical history included Graves' disease and concomitant medications not reported. She was vaccinated with FLUVIRIN (batch number: 1102101) intramuscularly on to left arm on 12 Nov 2011. On the same day, she experienced erythema with possible infection at injection site. She visited emergency room. The outcome of the events was reported as condition unchanged as of 14 Nov 2011. Based on the document review, it was stated that the concerned FLUVIRIN batch number 1102101 was manufactured in accordance with approved internal procedures and were in compliance with the current good manufacturing practices (cGMP) requirements. Follow-up received from the quality assurance department (reference number: 146125) on 02 Apr 2012: Updated batch review report.
Age: 0.17
Sex: F
Vaccine: RV5
Symptoms: Crying, Oral administration complication, Presyncope, Skin discolouration, Vomiting
Clinical narrative: Information has been received from a doctor of osteopathy concerning a 61 day old female infant patient with no pertinent medical history and no drug reactions/allergies who on 21-DEC-2011, was vaccinated orally with the first dose of ROTATEQ (Lot number: 670014/0918AA). It was reported that during administration of the 2ml dose of ROTATEQ, on 21-DEC-2011, the patient vomited, and she might have only received half of the dose. It was reported that while the patient was vomiting and crying, the patient's entire left leg "turned purple". The color change in the patient's left leg lasted for 5 minutes, and then the patient's left leg returned to the normal color. Physician suspected that the color change was related to a "vagal response". No lab diagnostics studies were performed. The patient saw the physician for medical attention. At the time of reporting it was unknown if the patient recovered from vomiting, crying and the vagal response. Additional information has been requested.
Age: 0.17
Sex: M
Vaccine: DTAPIPVHIB, PNC13, RV5, RV5
Symptoms: Haematochezia
Clinical narrative: Information has been received from a licensed practical nurse concerning an approximately 10 week old male infant who on 20-OCT-2011, was vaccinated with a first dose of ROTATEQ (lot number: 1155Z/0563AA, expiration date: 30-JUN-2012, dose and route not reported). It was reported that ten days after vaccination of ROTATEQ, on 30-OCT-2011, the patient experienced chronic hematochezia, that had not subsided. The patient was only given one dose of ROTATEQ. It was unspecified if the patient sought medical attention. This is an amended report. The lot number for the first dose of ROTATEQ in the lot # field and the narrative now reads 668905/0563AA instead of 1155Z/0563AA. Additional information has been requested.
Age: 61.0
Sex: F
Vaccine: FLU3
Symptoms: Balance disorder, Computerised tomogram normal, Dysarthria, Electromyogram, Hypoaesthesia
Clinical narrative: 10-20-11 rash in armpits (bought BENADRYL) 1 wk followed by fingertips completely numb, vision went totally blurry, then had no balance, speech slurred, finally went to ER on 11-15-11.
Age: 61.0
Sex: F
Vaccine: FLU3
Symptoms: Lumbar puncture, Nuclear magnetic resonance imaging normal, Rash, Vision blurred
Clinical narrative: 10-20-11 rash in armpits (bought BENADRYL) 1 wk followed by fingertips completely numb, vision went totally blurry, then had no balance, speech slurred, finally went to ER on 11-15-11.
Age: 19.0
Sex: F
Vaccine: SMALL
Symptoms: Maternal exposure during pregnancy
Clinical narrative: Pt found out she was pregnant on 3/26/12. Smallpox shot was given week prior.
Age: 2.0
Sex: F
Vaccine: RAB
Symptoms: Injection site reaction, Rash maculo-papular, Rash pruritic
Clinical narrative: Mildly pruritic maculopapular rash at sites of immunoglobulin injection & rabies vaccines injection. Asked mom to give 2-5 ml of children's BENADRYL every 8-10 hrs as needed.
Age: 18.0
Sex: F
Vaccine: HPV4
Symptoms: Condition aggravated, Convulsion, Seizure like phenomena
Clinical narrative: Information has been received from a registered nurse (R.N.) concerning an 18 year old female patient with a known seizure disorder that was well-controlled who on an unknown date, was vaccinated with a first dose of GARDASIL (dose, route and lot number not reported). Concomitant therapy included "several seizure meds" and oral contraceptives started at the same time as vaccinations with GARDASIL. It was reported that the patient developed tiny seizures, minor seizure-like episodes randomly in the weeks after vaccination and did not appeared to be syncopal in nature, however, however, the episodes were not full blown seizures. The reporter stated that she was aware that the birth control prescribed was known to decrease the efficacy of one of the "several seizure meds" the patient had been taking concomitantly. It was unknown if the patient sought medical attention. At the time of the report, the patient's outcome was unknown. Upon internal review, tiny seizures, minor seizure-like episodes were determined to be other important medical events. Additional information has been requested.
Age: 1.0
Sex: M
Vaccine: MMR
Symptoms: Autism, Childhood disintegrative disorder, Decreased eye contact, Measles, Pyrexia
Clinical narrative: Patient did have an underlying medical condition of a mitochondrial disease at the time of his vaccine. Within about 7 days of receiving the vaccine he started running a fever, by day 7 he started with a rash, by day 10 he was covered head to toe in a measles rash, within a couple days his fever had spiked to 106 and he began vomiting, was hospitalized overnight. Prior to vaccine, babbling, smiling, happy. Within 2 weeks of vaccine he never smiled, babbled, or made eye contact again. It has been 18 months and he has now been diagnosed with low functioning autism.
Age: 1.0
Sex: M
Vaccine: MMR
Symptoms: Rash generalised, Vomiting
Clinical narrative: Patient did have an underlying medical condition of a mitochondrial disease at the time of his vaccine. Within about 7 days of receiving the vaccine he started running a fever, by day 7 he started with a rash, by day 10 he was covered head to toe in a measles rash, within a couple days his fever had spiked to 106 and he began vomiting, was hospitalized overnight. Prior to vaccine, babbling, smiling, happy. Within 2 weeks of vaccine he never smiled, babbled, or made eye contact again. It has been 18 months and he has now been diagnosed with low functioning autism.
Age: 5.0
Sex: F
Vaccine: DTAP, IPV, MMR, VARCEL
Symptoms: Agitation, Decreased appetite, Epilepsy, Grand mal convulsion, Laboratory test
Clinical narrative: At around 9:00 pm, patient became agitated and was resting on the couch. Had little appetite for dinner. Father heard a noise and turned around to see patient having a generalized tonic clonic seizure. She was taken to Hospital wher she had several subsequent GTC seizures.
Age: 61.0
Sex: F
Vaccine: VARZOS, VARZOS
Symptoms: Injection site pain, Injection site pruritus, Injection site warmth
Clinical narrative: Injection site became tender, hot and itchy.  Applied over the counter anti itch medication.
Age: 61.0
Sex: F
Vaccine: VARZOS, VARZOS
Symptoms: Injection site erythema, Injection site induration, Injection site pain, Injection site swelling, Injection site warmth
Clinical narrative: Injection site became tender, hot and itchy.  Applied over the counter anti itch medication.
Age: 4.0
Sex: F
Vaccine: DTAPIPV
Symptoms: Cyanosis, Injection site erythema, Joint swelling, Oedema peripheral
Clinical narrative: Mom called another provider in one of our satellite offices stating arm where the KINRIX was given had areas of pinprick redness. Mom said shoulder is purple and swollen to size of softball. Swelling from shoulder to elbow. The provider mom spoke to advised visit to walk in clinic. Mom said walk in clinic gave BENADRYL swelling went down significantly.
Age: 0.37
Sex: M
Vaccine: DTAPIPVHIB, HEP
Symptoms: Drug administered at inappropriate site, No adverse event
Clinical narrative: Patient was administered Hep B vaccine on wrong WCC. No adverse reactions. Documented as an invalid dose. Mother notified.
Age: 72.0
Sex: F
Vaccine: VARZOS
Symptoms: Abasia, Arthritis, Condition aggravated, Skin mass
Clinical narrative: 1 day later after shot, she stated she couldn't walk on one foot. She's had nodes on hands & back of cranium before shot. She never had nodes on foot before shot. Her arthritis flared. Her nodes all enlarged after shot all over body.
Age: 42.0
Sex: F
Vaccine: TDAP
Symptoms: Injection site erythema, Injection site pain, Injection site swelling
Clinical narrative: Pain, redness, and swelling at injection site 5cm circumferential area of light erythema, swelling, tenderness on exam. Treatment: MEDROL dose pak and cephalexin 500mg x 7 days.
Age: 0.35
Sex: F
Vaccine: DTAPIPVHIB, PNC13, RV5
Symptoms: Vaccine positive rechallenge, Vomiting
Clinical narrative: 2/16/12 received PCV13, PENTACEL (DTaP, Hib, IPV), ROTATEQ and vomited right away-large amounts. 4/9/12 received PCV13, PENTACEL, ROTATEQ and vomited within 24 hours of immunes.
Age: 82.0
Sex: M
Vaccine: PPV
Symptoms: Nausea, Vomiting
Clinical narrative: Nausea, vomiting.
Age: 0.34
Sex: F
Vaccine: DTAPHEPBIP, HIBV, PNC13, RV1
Symptoms: Crying, Injection site erythema, Injection site induration, Pyrexia
Clinical narrative: Crying a lot, fever 102.3, on thighs where shots were given area of redness and induration. F/u 1 week use warm soaks & massage.
Age: 0.82
Sex: F
Vaccine: HEP
Symptoms: Electrocardiogram normal, Hypotonia, Lethargy, Pallor, Presyncope
Clinical narrative: Vasovagal reaction 28 hours following Hep B vaccine. Vomited at home & then 5-10 min later became limp, pale & lethargic. Pulse 160 RR 24.
Age: 0.82
Sex: F
Vaccine: HEP
Symptoms: Vomiting
Clinical narrative: Vasovagal reaction 28 hours following Hep B vaccine. Vomited at home & then 5-10 min later became limp, pale & lethargic. Pulse 160 RR 24.
Age: 1.28
Sex: F
Vaccine: DTAP, HIBV, MMR, PNC13, VARCEL
Symptoms: Erythema, Rash, Rash macular
Clinical narrative: Initial report received from a health care professional on 11 May 2011. A 15-month-old female child, with a slight rash on the chest at the time of vaccination, received an injection (route and site not reported) of DAPTACEL, sanofi pasteur, lot number not reported, and four other vaccines (name, manufacturer and lot numbers not reported) on 11 May 2011. After a few minutes, the patient's face became all red and she developed a rash. The patient was sent to Urgent Care Center. No other information reported at this time. The outcome was reported as not recovered. Follow-up information was received from a health care professional on 17 May 2011. The patient had a possible rash at the time of vaccination. The patient's medical history and concomitant medications were reported as unknown. It was reported as none known in regard to the patient receiving any other vaccinations within 4 weeks. Prior to vaccinations the patient's mother pointed out small pinpoint rash near right axilla. On 11 May 2011 at 10:30 AM the patient received the following vaccines: an intramuscular left thigh (dose 4) injection of ACTHIB, sanofi pasteur lot number UH172AA and sanofi pasteur SA lot number E1030-1, an intramuscular left thigh (dose 4) injection of DAPTACEL, sanofi pasteur Ltd. lot number C3380AA, a subcutaneous right thigh (dose 1) injection of MMR II, Merck lot number 0872Y, a subcutaneous left thigh (dose 1) of VARIVAX, Merck lot number 12792, and an intramuscular right thigh injection of PCV13, "WAL" manufacturer 915252. Following the 5 immunizations, after approximately 10-15 minutes on 11 May 2011, the mother returned to the clinic with the child who presented with raised rash covering most of chest and with a blotchy red face. The patient had no respiratory problems and was not crying. The mother was to seek treatment at a doctors or urgent care. It was unknown if the treatment was sought or if any diagnostic or laboratory testing was performed. The outcome was reported as unknown. Follow-up information was received on 08 June 2011 from a health care professional. According to the reporter, no additional information to add, unable to contact client. No further information was provided at the time of the report. The patient's outcome was not reported. Follow-up information was received 21 June 2011 from a health care professional. The PCV13 vaccine had been manufactured by Wyeth Pharmaceuticals. According to the reporter, the patient's outcome, and their physician's contact information, were unknown. No additional information was provided. Documents held by sender: None.
Sex: U
Vaccine: RV5
Symptoms: Convulsion, Hypernatraemia, Rotavirus test positive
Clinical narrative: Information has been received from a medical assistant reported a nurse from a hospital concerning a patient who on "yesterday morning" (06-Jul-2011), was vaccinated with ROTATEQ (lot number, dose, route not reported). "Last night" (06-Jul-2011), the patient had a seizure and was hospitalized. Rotavirus was found in stool sample. The patient had hypernatremia. At the time of reporting, the outcome was unknown. All telephone attempts to obtain follow information have been unsuccessful. Additional information had been requested.
Age: 0.17
Sex: M
Vaccine: DTAPHEPBIP, HIBV, PNC13, RV5
Symptoms: Diarrhoea, Rotavirus test negative, Vomiting
Clinical narrative: Information has been received from a physician concerning an 8-week-old male infant who on 08-NOV-2011 was orally vaccinated with a dose of ROTATEQ (Lot number: 670481/0677AA, expiration date 28-FEB-2013). The physician stated that on 09-NOV-2011 the patient developed diarrhea. The child presented at the office on 14-NOV-2011, with diarrhea and vomiting for the last 5 days. The child was examined and sent home. On 21-NOV-2011, the child was admitted to the hospital through the emergency room and remained there until 23-NOV-2011, after which the child was released. The representative did not have any details of the hospital stay and it was not the reporting physician who admitted the child. A test was done for rotavirus and it came back negative. On a call taken by the nurse with the reporting physician in the background stated that concomitant vaccines included a dose of PEDIARIX, ACTHIB, and PREVNAR 13. Patient did not present with vomiting at the 14-NOV-2011 office visit (as previously reported), the only symptom at that time was diarrhea, which was not tested for presence of blood: the hospital records had been received. Baby was seen again in the office on 29-NOV-2011, no vomiting; no blood or mucous in the stool; stool was getting thicker; patient was considered as recovering. No further information is available.
Age: 0.2
Sex: U
Vaccine: RV5
Symptoms: Diarrhoea, Vomiting
Clinical narrative: Information has been received from a physician concerning an approximately 8 week old patient with a history of reflux disease who on an unknown date was vaccinated with the first dose of ROTATEQ (lot# unspecified) by oral. Shortly after administration, the patient developed vomiting and diarrhea. The patient was admitted to an unspecified hospital. The patient received hydration therapy and was discharged. The physician added that the patient continued to have "occasional bouts of vomiting". At the time of reporting, the outcome of the adverse events was recovering. Additional information has been requested.
Age: 0.12
Sex: F
Vaccine: RV5
Symptoms: Convulsion, Incorrect dose administered, Oral administration complication, Vomiting
Clinical narrative: Information has been received from a nurse practitioner concerning an "approximately four months old" female who "approximately two months ago", in approximately December 2010, was vaccinated with a dose of ROTATEQ (therapy route and lot # not provided). Secondary suspect therapy included a dose of RECOMBIVAX (therapy route and lot # not provided). Patient was also given PENTACEL and PREVNAR. It was reported that "approximately two months ago", in approximately December 2010, the patient was given ROTATEQ at another Health Care Professional (HCP)'s office, and threw it up and so the other HCP's office gave the patient a second dose of ROTATEQ and the patient had a seizure. Treatment given for the adverse event (AE) was unspecified. Patient sought unspecified medical attention. AE improved while patient was on therapy. Therapy continued and was reported as not reappear after reintroduction. At the time of reporting, the patient had recovered. Upon internal review, seizure was determined to be an other important medical event. Follow-up information was received from a licensed practical nurse who reported that the patient was a 45 day old female with no known drug allergies. On 18-NOV-2011 patient threw up the first dose of ROTATEQ and right after it the patient was given another dose. Either dose was with lot # 667459/0502Z. One to two days after that dosing, on approximately 19-NOV-2011 the patient had the seizure, event learned from the family at the time of patient's first visit on 04-FEB-2011. On 01-MAR-2011, patient received the second dose of ROTATEQ (therapy route and lot # not provided) with no problem. No further information is available.
Age: 0.2
Sex: F
Vaccine: DTAPIPVHIB, HIBV
Symptoms: Incorrect dose administered, No adverse event
Clinical narrative: Initial report was received from a patient on 01 December 2011. A 2-months-old female patient had received an injection of ACTHIB (lot number, route and site of administration not reported). The patient had received both ACT-HIB and PENTACEL on the same office visit. The patient is now 6 months old, without any adverse events. No further information was available at the time of the report. The patient outcome was not reported. Documents held by sender: None.
Age: 77.0
Sex: F
Vaccine: PPV
Symptoms: Chest discomfort, Cough, Dysphonia, Dyspnoea, Fatigue
Clinical narrative: Pt called office 3/29/12 c/o dry cough, heaviness in chest. Symptoms started yesterday (day she got PNUEMOVAX 23). Advised MUCINEX DM, declines OV. 3/30/12, increased SOB, fever about 101 degrees, hoarse, body aches, fatigue. Declines OV. Dr reviewed chart. Rec: TYLENOL prn, DC MUCINEX, BENADRYL qhs 4-10-12 pt. feeling better. Some fatigue . Dry cough.
Age: 77.0
Sex: F
Vaccine: PPV
Symptoms: Pain, Pyrexia
Clinical narrative: Pt called office 3/29/12 c/o dry cough, heaviness in chest. Symptoms started yesterday (day she got PNUEMOVAX 23). Advised MUCINEX DM, declines OV. 3/30/12, increased SOB, fever about 101 degrees, hoarse, body aches, fatigue. Declines OV. Dr reviewed chart. Rec: TYLENOL prn, DC MUCINEX, BENADRYL qhs 4-10-12 pt. feeling better. Some fatigue . Dry cough.
Age: 0.19
Sex: F
Vaccine: RV5, UNK
Symptoms: Crying
Clinical narrative: Information has been received from a physician concerning a 10 weeks old female patient with no pertinent medical history and no drug reactions/allergies who on 12-OCT-2011, was vaccinated with the first dose of ROTATEQ, oral. On 12-OCT-2011, the child also received other unspecified vaccines that should be administered at two months of age. On 16-OCT-2011, four days after receiving ROTATEQ, the patient began crying inconsolably for three straight hours. No treatment was given for the AE. On 15-NOV-2011, the patient's outcome was recovered. No laboratory diagnostic studies were performed. The parents mentioned the AE occurrence during the child's three month check-up visit on 15-NOV-2011. Additional information has been requested.
Age: 0.3
Sex: F
Vaccine: RV5
Symptoms: Diarrhoea
Clinical narrative: Information has been received from a physician concerning a 16 weeks female patient who within the last several months was orally vaccinated with the second dose of ROTATEQ (Lot # and expiration not reported). It was reported that on an unspecified date, 24 hours after receiving the second dose of ROTATEQ the patient experienced severe diarrhea. The patient sought unspecified medical attention. It was reported that the patient would not receive the third dose ROTATEQ. At the time of reporting the outcome of the patient was unknown. This is one of several reports from the same source. Additional information has been requested.
Age: 12.0
Sex: F
Vaccine: HPV4, HPV4
Symptoms: Abdominal pain upper, Chest pain, Computerised tomogram, Decreased appetite, Endoscopy gastrointestinal
Clinical narrative: First Gardasil shot was given and within a two months she started having stomach pain. In ER on 7/4/11. 2nd Gardasil shot was given on 10/20/2011 and symptoms started getting worse. In ER on 11/16/11. Doctors were still making guesses as to what and why she is having this stomach pain. 3rd Gardasil shot was given on 03/14/2012 and we were in the ER again within a week (03/21/12). She's seeing a Gastrologist whom has one more test to run and then they are clueless. The onset of her symptoms started after the first shot and have increased in severity after each one. This vaccine has attacked her immune system and created medical issues. Symptoms to date are as follows: Stomach pain high & low as well as left side and right side, Headaches, fatigue, leg pain, nausea, Chest pain, insomnia, loss of appetite, light sensitivity, Moodiness.
Age: 12.0
Sex: F
Vaccine: HPV4, HPV4
Symptoms: Fatigue, Headache, Insomnia, Laboratory test, Mood altered
Clinical narrative: First Gardasil shot was given and within a two months she started having stomach pain. In ER on 7/4/11. 2nd Gardasil shot was given on 10/20/2011 and symptoms started getting worse. In ER on 11/16/11. Doctors were still making guesses as to what and why she is having this stomach pain. 3rd Gardasil shot was given on 03/14/2012 and we were in the ER again within a week (03/21/12). She's seeing a Gastrologist whom has one more test to run and then they are clueless. The onset of her symptoms started after the first shot and have increased in severity after each one. This vaccine has attacked her immune system and created medical issues. Symptoms to date are as follows: Stomach pain high & low as well as left side and right side, Headaches, fatigue, leg pain, nausea, Chest pain, insomnia, loss of appetite, light sensitivity, Moodiness.
Age: 12.0
Sex: F
Vaccine: HPV4, HPV4
Symptoms: Nausea, Pain in extremity, Photophobia, Ultrasound scan, X-ray
Clinical narrative: First Gardasil shot was given and within a two months she started having stomach pain. In ER on 7/4/11. 2nd Gardasil shot was given on 10/20/2011 and symptoms started getting worse. In ER on 11/16/11. Doctors were still making guesses as to what and why she is having this stomach pain. 3rd Gardasil shot was given on 03/14/2012 and we were in the ER again within a week (03/21/12). She's seeing a Gastrologist whom has one more test to run and then they are clueless. The onset of her symptoms started after the first shot and have increased in severity after each one. This vaccine has attacked her immune system and created medical issues. Symptoms to date are as follows: Stomach pain high & low as well as left side and right side, Headaches, fatigue, leg pain, nausea, Chest pain, insomnia, loss of appetite, light sensitivity, Moodiness.