chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 21.0
Sex: M
Vaccine: SMALL, YF
Symptoms: Red blood cell sedimentation rate, Troponin I
Clinical narrative: This case was received on 14 February 2011 via a QScan search on the VAERS database, under reference number 411689. A 21-year-old male patient received the following vaccinations on 12 November 2010: a percutaneous ACAM2000 (lot number VV04003A), a subcutaneous YF VAX, lot number UT785AA. The patient had no medical history and no current illnesses. On 23 November 2010, the patient developed dyspnoea, flank pain, chest pain and pericarditis. He required an Emergency visit and was admitted to the hospital. The following tests were performed; however, the results were not reported: antinuclear antibody, blood creatine phosphokinase, blood thyroid stimulating hormone, electrocardiogram, echocardiogram, full blood count, metabolic function test, red blood cell sedimentation rate and troponin I. The outcome was reported as unknown. Documents held by sender: None.
Age: 30.0
Sex: M
Vaccine: YF, YF, YF
Symptoms: Abdominal pain upper, Incorrect dose administered
Clinical narrative: Initial report received from a health care professional on 10 January 2011. The reporter provided a copy of a VAERS report (temporary VAERS E-report number E-51259) that was submitted by a military health care professional. A 30 year-old male patient who had no concurrent illnesses, pre-existing medical conditions, or use of other medications had received a subcutaneous left arm injection of YF VAX (lot number UF785AA) on 09 January 2011 at 10:22am that was 5 times the recommended adult dose (also reported as patient had received 2.5ml instead of 0.5ml). The following day, the patient developed a sore arm (time not reported) and that same day around 12:00pm which was approximately 13 hours post-vaccination the patient complained of upper abdominal pain and was advised to go the emergency room in compliance with poison control. The patient went to the hospital for treatment, however type of treatment received was not reported. It was unknown what relevant diagnostic tests and or laboratory data were performed. It was noted the patient had received a yellow fever vaccination 10 years earlier, however it was not reported whether the patient had experienced any adverse events with that vaccination. The patients recovery status for the events of sore arm and abdominal pain were unknown. Follow-up information was received from the health care professional on 24 March 2011. The patient had not experienced any adverse reactions following previous administration of yellow fever vaccine. The exact dose of YF-VAX received on 09 January 2011 was 2.5 mL. The patient was seen in the emergency department, where he underwent laboratory testing and was discharged. Per the reporter, no discharge summary was available, however test results were negative. The patient did not experience any further symptoms, and subsequently recovered on an unspecified date. According to a note from the patient's health record, Poison Control had been notified immediately of the overdose, and the recommendation was TYLENOL, or MOTRIN and supportive care as needed. It was not reported if the patient had received any treatment. Per the reporter, a new policy had been implemented immediately following this event which required that an RN administer live virus vaccines; in addition, all yellow-fever vaccine doses were to be double-checked by 2 providers prior to administration. Documents held by sender: None.
Age: 30.0
Sex: M
Vaccine: YF, YF, YF
Symptoms: Abdominal pain upper, Incorrect dose administered, Pain in extremity
Clinical narrative: Initial report received from a health care professional on 10 January 2011. The reporter provided a copy of a VAERS report (temporary VAERS E-report number E-51259) that was submitted by a military health care professional. A 30 year-old male patient who had no concurrent illnesses, pre-existing medical conditions, or use of other medications had received a subcutaneous left arm injection of YF VAX (lot number UF785AA) on 09 January 2011 at 10:22am that was 5 times the recommended adult dose (also reported as patient had received 2.5ml instead of 0.5ml). The following day, the patient developed a sore arm (time not reported) and that same day around 12:00pm which was approximately 13 hours post-vaccination the patient complained of upper abdominal pain and was advised to go the emergency room in compliance with poison control. The patient went to the hospital for treatment, however type of treatment received was not reported. It was unknown what relevant diagnostic tests and or laboratory data were performed. It was noted the patient had received a yellow fever vaccination 10 years earlier, however it was not reported whether the patient had experienced any adverse events with that vaccination. The patients recovery status for the events of sore arm and abdominal pain were unknown. Follow-up information was received from the health care professional on 24 March 2011. The patient had not experienced any adverse reactions following previous administration of yellow fever vaccine. The exact dose of YF-VAX received on 09 January 2011 was 2.5 mL. The patient was seen in the emergency department, where he underwent laboratory testing and was discharged. Per the reporter, no discharge summary was available, however test results were negative. The patient did not experience any further symptoms, and subsequently recovered on an unspecified date. According to a note from the patient's health record, Poison Control had been notified immediately of the overdose, and the recommendation was TYLENOL, or MOTRIN and supportive care as needed. It was not reported if the patient had received any treatment. Per the reporter, a new policy had been implemented immediately following this event which required that an RN administer live virus vaccines; in addition, all yellow-fever vaccine doses were to be double-checked by 2 providers prior to administration. Documents held by sender: None.
Age: 30.0
Sex: M
Vaccine: YF, YF, YF
Symptoms: Abdominal pain upper, Incorrect dose administered, Laboratory test normal, Pain in extremity
Clinical narrative: Initial report received from a health care professional on 10 January 2011. The reporter provided a copy of a VAERS report (temporary VAERS E-report number E-51259) that was submitted by a military health care professional. A 30 year-old male patient who had no concurrent illnesses, pre-existing medical conditions, or use of other medications had received a subcutaneous left arm injection of YF VAX (lot number UF785AA) on 09 January 2011 at 10:22am that was 5 times the recommended adult dose (also reported as patient had received 2.5ml instead of 0.5ml). The following day, the patient developed a sore arm (time not reported) and that same day around 12:00pm which was approximately 13 hours post-vaccination the patient complained of upper abdominal pain and was advised to go the emergency room in compliance with poison control. The patient went to the hospital for treatment, however type of treatment received was not reported. It was unknown what relevant diagnostic tests and or laboratory data were performed. It was noted the patient had received a yellow fever vaccination 10 years earlier, however it was not reported whether the patient had experienced any adverse events with that vaccination. The patients recovery status for the events of sore arm and abdominal pain were unknown. Follow-up information was received from the health care professional on 24 March 2011. The patient had not experienced any adverse reactions following previous administration of yellow fever vaccine. The exact dose of YF-VAX received on 09 January 2011 was 2.5 mL. The patient was seen in the emergency department, where he underwent laboratory testing and was discharged. Per the reporter, no discharge summary was available, however test results were negative. The patient did not experience any further symptoms, and subsequently recovered on an unspecified date. According to a note from the patient's health record, Poison Control had been notified immediately of the overdose, and the recommendation was TYLENOL, or MOTRIN and supportive care as needed. It was not reported if the patient had received any treatment. Per the reporter, a new policy had been implemented immediately following this event which required that an RN administer live virus vaccines; in addition, all yellow-fever vaccine doses were to be double-checked by 2 providers prior to administration. Documents held by sender: None.
Age: 20.0
Sex: M
Vaccine: SMALL, YF, SMALL, YF
Symptoms: Urticaria
Clinical narrative: This case was received on 26 April 2011 via a third party query tool search on the VAERS database, under reference number 415955. A 20-year-old male patient received the following vaccinations on 14 January 2011: ACAM2000 (lot number VV04003A), and YF-VAX (lot number UF785AA). On 25 January 2011, 11 days after vaccination, the patient developed vaccinia from vaccination, generalized multiple raised wheals covering the front and back of their torso, front and back of both arms and areas of the head and neck. Corrective treatment consisted of Prednisone 10 mg. The patient had no concurrent illness at the time of vaccination and no past medical history. Outcome was unknown. Note: MedDRA coding for the event of "vaccinia from vaccination, generalized multiple raised wheals" had not been captured in the report received; therefore, MedDRA coding for generalized vaccinia has been added to the case. List of documents held by sender: none.
Age: 20.0
Sex: M
Vaccine: SMALL, YF, SMALL, YF
Symptoms: Urticaria, Vaccinia virus infection
Clinical narrative: This case was received on 26 April 2011 via a third party query tool search on the VAERS database, under reference number 415955. A 20-year-old male patient received the following vaccinations on 14 January 2011: ACAM2000 (lot number VV04003A), and YF-VAX (lot number UF785AA). On 25 January 2011, 11 days after vaccination, the patient developed vaccinia from vaccination, generalized multiple raised wheals covering the front and back of their torso, front and back of both arms and areas of the head and neck. Corrective treatment consisted of Prednisone 10 mg. The patient had no concurrent illness at the time of vaccination and no past medical history. Outcome was unknown. Note: MedDRA coding for the event of "vaccinia from vaccination, generalized multiple raised wheals" had not been captured in the report received; therefore, MedDRA coding for generalized vaccinia has been added to the case. List of documents held by sender: none.
Age: 0.3
Sex: F
Vaccine: DTAPIPVHIB, PNC13, RV5, DTAPH, PNC13, RV5, DTAPH, PNC13, RV5
Symptoms: X-ray abnormal
Clinical narrative: This report was identified from a line listing obtained on request by the Company from the Company from the FDA under the Freedom of Information Act. A 16 week old female with no known drug allergy; no past hospitalization; no pertinent medical history and no previous illness who on 31-JAN-2011 was vaccinated with the second dose of ROTATEQ (dose not reported, lot # 669074/1526Z) by mouth. Second suspect therapy included the second dose of TRIHIBIT (dose not reported, lot # C3808AB) IM to the right leg and PREVNAR 13 (dose not reported, lot # E234419) IM to the left leg. On 01-FEB-2011 the patient was presented to ER with bilious emesis vomiting (4-5 times) and fever. The patient was lethargic or developed lethargy and was found to have an intussusception and Meckel's diverticulum. Mass was resected and reduced successfully. The patient had received 4-month-old immunizations on Monday. The parent reported no irritability or crying. Upon presentation, patient was in no obvious distress and temperature was 98.5  Fahrenheit. Examination noted that patient's abdomen was distended with good bowel sounds and was non tender to palpation. KUB revealed gaseous distention small bowel & colon and recommended clinical follow-up. While in the emergency room, the parent noted the patient was more lethargic and laboratory testing revealed leukocytosis. Blood glucose test showed 125, serum potassium test showed: 5.4, white blood cell count showed: 25.4, blood lymphocyte count showed 20, blood neutrophil count showed 73, urine culture showed no growth. Abdominal x-ray showed s. bowel w/air-fluid levels consistent w/ small bowel obstruction; abdominal ultrasound showed abnormal (distended loops of bowel-poss. intussusception or SB obstruction. In the emergency room, the patient received IV fluids, ZOFRAN and ROCEPHIN. The patient was admitted. On 29-APR-2011, primary care physician office records, x-ray report and vaccine record were received for dates of service 31-JAN-11 to 11-APR-11. Impression: intussusception. On 11-FEB-11, that patient was seen due to hospital follow-up for intussusception. The patient's incision was clean and intact, abdomen soft. The patient was next seen on 04-APR-2011 due to diarrhea and diaper rash. On 11-APR-2011, the patient was seen due to worsening diaper rash and blood in stool and the patient's examination noted bloody lesions on bottom. Patient was planned prescribed with nystatin, AQUAPHOR and QUESTRAN. At the time of reporting, the outcomes were unknown. The listing indicated that one or more of the events required hospitalization and was considered to be immediately life-threatening. No further information is available. A preliminary lot check investigation was performed. To date our investigation has found that this lot conformed to quality release parameters and the manufacturing was typical of a lot of (PRODUCT NAME). Additional information will be provided upon finalization of this manufacturing investigation. The original reporting source was nor provided. The VAERS ID# is 421245.
Age: 16.0
Sex: F
Vaccine: HEPA, HPV4, HEPA, HPV4
Symptoms: Antinuclear antibody, Antiphospholipid syndrome, Autoimmune disorder, Fatigue, Malaise
Clinical narrative: Information has been received from a registered nurse and a consumer concerning a 17 year old female patient (also was the consumer's daughter) with no pertinent medical history and no drug reactions or allergies who on 15-OCT-2009 was vaccinated intramuscularly with the first 0.5 dose of GARDASIL (lot # 663453/0249Y). On 29-APR-2009 the patient received a dose of VARIVAX (lot # 663802/0160Y) and concomitantly received BOOSTRIX (GlaxoSmithKline) (lot# AC52BO31AB) and MENACTRA (lot # U2868AA). On 15-OCT-2009 the patient concomitantly received HAVRIX (GlaxoSmithKline) (lot# AHAVB212AA). The consumer reported that in approximately September 2010, the daughter had been diagnosed with rheumatoid arthritis, systemic visceral involvement, fatigue, malaise, systemic lupus erythematosus, temporomandibular joint syndrome (TMJ syndrome), anticardiolipin antibody syndrome and systemic lupus erythematosus. The consumer also reported that the daughter had been having extreme headaches. The patient was working with their healthcare provider to address the symptoms. No treatment was given for the adverse events. From "June 6th through June 10th multiple tests" were performed (results not reported). At the time of reporting, the patient had not recovered. Upon internal review, systemic lupus erythematosus was determined to be an other important medical event. Additional information has been requested.
Age: 16.0
Sex: F
Vaccine: HEPA, HPV4, HEPA, HPV4
Symptoms: Migraine, Nasopharyngitis, Rheumatoid arthritis, Sinus disorder, Systemic lupus erythematosus
Clinical narrative: Information has been received from a registered nurse and a consumer concerning a 17 year old female patient (also was the consumer's daughter) with no pertinent medical history and no drug reactions or allergies who on 15-OCT-2009 was vaccinated intramuscularly with the first 0.5 dose of GARDASIL (lot # 663453/0249Y). On 29-APR-2009 the patient received a dose of VARIVAX (lot # 663802/0160Y) and concomitantly received BOOSTRIX (GlaxoSmithKline) (lot# AC52BO31AB) and MENACTRA (lot # U2868AA). On 15-OCT-2009 the patient concomitantly received HAVRIX (GlaxoSmithKline) (lot# AHAVB212AA). The consumer reported that in approximately September 2010, the daughter had been diagnosed with rheumatoid arthritis, systemic visceral involvement, fatigue, malaise, systemic lupus erythematosus, temporomandibular joint syndrome (TMJ syndrome), anticardiolipin antibody syndrome and systemic lupus erythematosus. The consumer also reported that the daughter had been having extreme headaches. The patient was working with their healthcare provider to address the symptoms. No treatment was given for the adverse events. From "June 6th through June 10th multiple tests" were performed (results not reported). At the time of reporting, the patient had not recovered. Upon internal review, systemic lupus erythematosus was determined to be an other important medical event. Additional information has been requested.
Age: 16.0
Sex: F
Vaccine: HEPA, HPV4, HEPA, HPV4
Symptoms: Temporomandibular joint syndrome
Clinical narrative: Information has been received from a registered nurse and a consumer concerning a 17 year old female patient (also was the consumer's daughter) with no pertinent medical history and no drug reactions or allergies who on 15-OCT-2009 was vaccinated intramuscularly with the first 0.5 dose of GARDASIL (lot # 663453/0249Y). On 29-APR-2009 the patient received a dose of VARIVAX (lot # 663802/0160Y) and concomitantly received BOOSTRIX (GlaxoSmithKline) (lot# AC52BO31AB) and MENACTRA (lot # U2868AA). On 15-OCT-2009 the patient concomitantly received HAVRIX (GlaxoSmithKline) (lot# AHAVB212AA). The consumer reported that in approximately September 2010, the daughter had been diagnosed with rheumatoid arthritis, systemic visceral involvement, fatigue, malaise, systemic lupus erythematosus, temporomandibular joint syndrome (TMJ syndrome), anticardiolipin antibody syndrome and systemic lupus erythematosus. The consumer also reported that the daughter had been having extreme headaches. The patient was working with their healthcare provider to address the symptoms. No treatment was given for the adverse events. From "June 6th through June 10th multiple tests" were performed (results not reported). At the time of reporting, the patient had not recovered. Upon internal review, systemic lupus erythematosus was determined to be an other important medical event. Additional information has been requested.
Age: 16.0
Sex: F
Vaccine: HEPA, HPV4, HEPA, HPV4
Symptoms: Antiphospholipid syndrome, Fatigue, Headache, Laboratory test, Malaise
Clinical narrative: Information has been received from a registered nurse and a consumer concerning a 17 year old female patient (also was the consumer's daughter) with no pertinent medical history and no drug reactions or allergies who on 15-OCT-2009 was vaccinated intramuscularly with the first 0.5 dose of GARDASIL (lot # 663453/0249Y). On 29-APR-2009 the patient received a dose of VARIVAX (lot # 663802/0160Y) and concomitantly received BOOSTRIX (GlaxoSmithKline) (lot# AC52BO31AB) and MENACTRA (lot # U2868AA). On 15-OCT-2009 the patient concomitantly received HAVRIX (GlaxoSmithKline) (lot# AHAVB212AA). The consumer reported that in approximately September 2010, the daughter had been diagnosed with rheumatoid arthritis, systemic visceral involvement, fatigue, malaise, systemic lupus erythematosus, temporomandibular joint syndrome (TMJ syndrome), anticardiolipin antibody syndrome and systemic lupus erythematosus. The consumer also reported that the daughter had been having extreme headaches. The patient was working with their healthcare provider to address the symptoms. No treatment was given for the adverse events. From "June 6th through June 10th multiple tests" were performed (results not reported). At the time of reporting, the patient had not recovered. Upon internal review, systemic lupus erythematosus was determined to be an other important medical event. Additional information has been requested.
Age: 16.0
Sex: F
Vaccine: HEPA, HPV4, HEPA, HPV4
Symptoms: Multi-organ disorder, Rheumatoid arthritis, Systemic lupus erythematosus, Temporomandibular joint syndrome
Clinical narrative: Information has been received from a registered nurse and a consumer concerning a 17 year old female patient (also was the consumer's daughter) with no pertinent medical history and no drug reactions or allergies who on 15-OCT-2009 was vaccinated intramuscularly with the first 0.5 dose of GARDASIL (lot # 663453/0249Y). On 29-APR-2009 the patient received a dose of VARIVAX (lot # 663802/0160Y) and concomitantly received BOOSTRIX (GlaxoSmithKline) (lot# AC52BO31AB) and MENACTRA (lot # U2868AA). On 15-OCT-2009 the patient concomitantly received HAVRIX (GlaxoSmithKline) (lot# AHAVB212AA). The consumer reported that in approximately September 2010, the daughter had been diagnosed with rheumatoid arthritis, systemic visceral involvement, fatigue, malaise, systemic lupus erythematosus, temporomandibular joint syndrome (TMJ syndrome), anticardiolipin antibody syndrome and systemic lupus erythematosus. The consumer also reported that the daughter had been having extreme headaches. The patient was working with their healthcare provider to address the symptoms. No treatment was given for the adverse events. From "June 6th through June 10th multiple tests" were performed (results not reported). At the time of reporting, the patient had not recovered. Upon internal review, systemic lupus erythematosus was determined to be an other important medical event. Additional information has been requested.
Age: 28.0
Sex: F
Vaccine: TDAP, TDAP
Symptoms: Headache, Laboratory test, Musculoskeletal stiffness, Pain in extremity, Pyrexia
Clinical narrative: Stiff arm, got worse over night, stiff arm, neck, back, face, high fever, arm very swollen. Called the dr. On call at dr. Office, was told to go to ER ASAP.
Age: 28.0
Sex: F
Vaccine: TDAP, TDAP
Symptoms: Ultrasound scan, X-ray
Clinical narrative: Stiff arm, got worse over night, stiff arm, neck, back, face, high fever, arm very swollen. Called the dr. On call at dr. Office, was told to go to ER ASAP.
Age: 28.0
Sex: F
Vaccine: TDAP, TDAP
Symptoms: Bacterial infection, Blood test, Musculoskeletal stiffness, Oedema peripheral, Pyrexia
Clinical narrative: Stiff arm, got worse over night, stiff arm, neck, back, face, high fever, arm very swollen. Called the dr. On call at dr. Office, was told to go to ER ASAP.
Age: 29.0
Sex: M
Vaccine: TDAP
Symptoms: Asthenia, Injection site swelling, Lymphadenopathy, Neuralgia
Clinical narrative: Weakness, swollen lymph node in between collar bone, swelling at injection site, nerve pain in arms.
Age: 14.0
Sex: F
Vaccine: HPV4
Symptoms: Colposcopy normal, Laboratory test, Smear cervix abnormal
Clinical narrative: Information has been received from a registered nurse concerning a female patient who on 18-MAY-2007 was vaccinated with a first dose of GARDASIL (route and lot numbers not reported). On 30-JUL-2007 the patient was vaccinated with a second dose of GARDASIL (route and lot numbers not reported). On 15-FEB-2008 the patient was vaccinated with a third dose of GARDASIL (route and lot numbers not reported). There was no concomitant medication, the patient did not receive other vaccines on any of the days she received GARDASIL. "Recently" (date unknown), the patient "had PAP smear done by her obstetrician-gynecologist, the PAP smear was abnormal and the patient would have an upcoming biopsy". The patient did not receive any treatment for the event. The patient sought medical attention by office visit. The nurse noted that the patient had not recovered. Follow up information has been received from a registered nurse concerning a 17 year old female student patient with no known drug allergies and no illness at time of vaccination who on 18-MAY-2007, was vaccinated with the first dose of GARDASIL intramuscularly in the left deltoid (lot number 656049/0187U). On 30-JUL-2007, the patient was vaccinated with the second dose of GARDASIL intramuscularly in the right deltoid (lot number 657737/0522U). On the morning at 11 A.M. of 15-FEB-2008, the patient was vaccinated with the third dose of GARDASIL intramuscularly in the left deltoid (lot number 659055/1522U). In April 2011, the patient had a PAP smear done at obstetrician/gynecologist. Smear and further test were done. On 19-MAY-2011, a colposcopy procedure would had be done. The mother of the patient called to the nurse and reported that report from obstetrician/gynecologist on the colposcopy was negative. At the time of the report the outcome of the patient was unknown. PAP smear abnormal was considered to be an other important medical event by the registered nurse because required medical/surgical intervention. Additional information has been requested.
Age: 69.0
Sex: M
Vaccine: PPV
Symptoms: Angioedema, Burning sensation, Cellulitis, Dermatitis exfoliative, Erythema
Clinical narrative: Information has been received from a registered pharmacist concerning a patient who on an unknown date was vaccinated with a dose of PNEUMOVAX 23 (Lot# and expiration not reported). Pharmacist reported that the patient was vaccinated with PNEUMOVAX 23 and experienced cellulitis. It was unspecified if the patient sought medical attention. At the time of reporting the patient's outcome was unknown. Follow up information has been received from a physician concerning a 69 year old male patient with allergy to amoxicillin and hydrochlorothiazide (+) triamterene developed hives, no illness at the time of vaccination and no adverse events following prior vaccination, who on an unspecified date was vaccinated with a dose of PNEUMOVAX 23 (Lot# and expiration not reported). Physician reported that on 03-MAY-2011 immediate (1 hr) the patient developed severe swelling increased for 24 hrs with burning, itching up to erythematous patch of 12x22 cm, warm giant hive and allergy erythroderma. It was reported that the patient recovered on 10-MAY-11. Cellulitis was considered by physician to be other important medical event because required medical intervention. Additional information has been requested.
Age: 69.0
Sex: M
Vaccine: PPV
Symptoms: Pruritus, Skin warm, Swelling, Urticaria
Clinical narrative: Information has been received from a registered pharmacist concerning a patient who on an unknown date was vaccinated with a dose of PNEUMOVAX 23 (Lot# and expiration not reported). Pharmacist reported that the patient was vaccinated with PNEUMOVAX 23 and experienced cellulitis. It was unspecified if the patient sought medical attention. At the time of reporting the patient's outcome was unknown. Follow up information has been received from a physician concerning a 69 year old male patient with allergy to amoxicillin and hydrochlorothiazide (+) triamterene developed hives, no illness at the time of vaccination and no adverse events following prior vaccination, who on an unspecified date was vaccinated with a dose of PNEUMOVAX 23 (Lot# and expiration not reported). Physician reported that on 03-MAY-2011 immediate (1 hr) the patient developed severe swelling increased for 24 hrs with burning, itching up to erythematous patch of 12x22 cm, warm giant hive and allergy erythroderma. It was reported that the patient recovered on 10-MAY-11. Cellulitis was considered by physician to be other important medical event because required medical intervention. Additional information has been requested.
Age: 5.0
Sex: M
Vaccine: HEPAB
Symptoms: Injection site erythema, Injection site swelling, Injection site warmth
Clinical narrative: (L) deltoid with redness, warmth, swelling. Mom gave BENADRYL and applied ice pack.
Age: 1.02
Sex: M
Vaccine: HEPA, VARCEL
Symptoms: Full blood count normal, Injection site pain, X-ray limb
Clinical narrative: 3 weeks after varicella/Hep A were given in right leg. Pt had unexplained tenderness, pain to leg.
Age: 7.0
Sex: F
Vaccine: DTAP
Symptoms: Cellulitis
Clinical narrative: Diffuse (R) arm cellulitis 24 hours after DTaP with improvement subsequently with BENADRYL.
Age: 63.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site swelling, Injection site warmth
Clinical narrative: Site swollen & hot to touch 5 x 3 cm. Grow next day to 10 x 9 cm. Over weekend took prednisone, BENADRYL to relieve symptoms. Ok w/flu shot. Only PNC, ASA, CIPRO allergy.
Age: 17.0
Sex: F
Vaccine: HPVX
Symptoms: Abdominal pain, Dyspnoea, Nausea, Throat tightness, Vomiting
Clinical narrative: SOB, tightness in throat, nausea and vomiting, abdominal cramping
Age: 2.0
Sex: F
Vaccine: HEPA, PNC13
Symptoms: Rash erythematous, Rash macular
Clinical narrative: Red, raised, blotchy rash on face, arms, back & stomach.  Benadryl 20mg IM
Age: 15.0
Sex: M
Vaccine: MNQ, VARCEL
Symptoms: Abdominal discomfort, Arthralgia, Headache, Injection site erythema, Injection site rash
Clinical narrative: 15 year old male presents with c/o rash Began to have rash in left shoulder this AM. Pt was given Menactra in this shoulder yesterday. Rash is erythematous and warm. Spread across upper chest and back. Has had joint aches, headache, subjective fever. Ibuprofen helps. +nausea and upset GI..
Age: 15.0
Sex: M
Vaccine: MNQ, VARCEL
Symptoms: Injection site warmth, Nausea, Pyrexia, Rash, Rash erythematous
Clinical narrative: 15 year old male presents with c/o rash Began to have rash in left shoulder this AM. Pt was given Menactra in this shoulder yesterday. Rash is erythematous and warm. Spread across upper chest and back. Has had joint aches, headache, subjective fever. Ibuprofen helps. +nausea and upset GI..
Age: 63.0
Sex: F
Vaccine: VARZOS
Symptoms: Bacterial infection, Blood test abnormal, Chest pain, Computerised tomogram abnormal, Culture throat negative
Clinical narrative: Initial raised and inflamed at site of injection.  By evening, low grade fever, sore throat, sore glands in throat, headache. Returned to Doctor on 06/23/2011.  Throat was swabbed for Strep (neg) and issued prescription for cephalexin 500mg.  Fever and throat swelling persisted until Sunday, 06/26/2011, when I couldn't swallow at all, 103 degree fever, swollen throat, and vomiting, pain in shoulder and chest.  Went to ER.  Cat Scan showed bacterial infection.  Given IVs of steroids and antibiotics.  Admitted to hospital Sunday 06/26/11, continued antibiotics and steroids.  Released Monday evening 06/27/2011 with prescription for Dexamethasone 4mg and Clindamycin HCL 150.  Throat seemed better. Low grade fever continued and by Thursday 06/30/2011 was back up to 102 degree.  Follow-up on Friday with Dr.  Told was getting better.  Fever and pain in shoulder and chest continues thru 07/05/2011, always around 102 degree.  Another Dr. Appointment.  Blood work taken and was told I had a viral infection of lymph nodes.  Treat fever.  Fever continues through Sat. 07/09/2011. Pain in shoulder and chest continues through 07/11/2011
Age: 63.0
Sex: F
Vaccine: VARZOS
Symptoms: Dysphagia, Headache, Injection site inflammation, Injection site swelling, Lymph gland infection
Clinical narrative: Initial raised and inflamed at site of injection.  By evening, low grade fever, sore throat, sore glands in throat, headache. Returned to Doctor on 06/23/2011.  Throat was swabbed for Strep (neg) and issued prescription for cephalexin 500mg.  Fever and throat swelling persisted until Sunday, 06/26/2011, when I couldn't swallow at all, 103 degree fever, swollen throat, and vomiting, pain in shoulder and chest.  Went to ER.  Cat Scan showed bacterial infection.  Given IVs of steroids and antibiotics.  Admitted to hospital Sunday 06/26/11, continued antibiotics and steroids.  Released Monday evening 06/27/2011 with prescription for Dexamethasone 4mg and Clindamycin HCL 150.  Throat seemed better. Low grade fever continued and by Thursday 06/30/2011 was back up to 102 degree.  Follow-up on Friday with Dr.  Told was getting better.  Fever and pain in shoulder and chest continues thru 07/05/2011, always around 102 degree.  Another Dr. Appointment.  Blood work taken and was told I had a viral infection of lymph nodes.  Treat fever.  Fever continues through Sat. 07/09/2011. Pain in shoulder and chest continues through 07/11/2011
Age: 63.0
Sex: F
Vaccine: VARZOS
Symptoms: Musculoskeletal pain, Oropharyngeal pain, Pharyngeal oedema, Pyrexia, Streptococcus test negative
Clinical narrative: Initial raised and inflamed at site of injection.  By evening, low grade fever, sore throat, sore glands in throat, headache. Returned to Doctor on 06/23/2011.  Throat was swabbed for Strep (neg) and issued prescription for cephalexin 500mg.  Fever and throat swelling persisted until Sunday, 06/26/2011, when I couldn't swallow at all, 103 degree fever, swollen throat, and vomiting, pain in shoulder and chest.  Went to ER.  Cat Scan showed bacterial infection.  Given IVs of steroids and antibiotics.  Admitted to hospital Sunday 06/26/11, continued antibiotics and steroids.  Released Monday evening 06/27/2011 with prescription for Dexamethasone 4mg and Clindamycin HCL 150.  Throat seemed better. Low grade fever continued and by Thursday 06/30/2011 was back up to 102 degree.  Follow-up on Friday with Dr.  Told was getting better.  Fever and pain in shoulder and chest continues thru 07/05/2011, always around 102 degree.  Another Dr. Appointment.  Blood work taken and was told I had a viral infection of lymph nodes.  Treat fever.  Fever continues through Sat. 07/09/2011. Pain in shoulder and chest continues through 07/11/2011
Age: 63.0
Sex: F
Vaccine: VARZOS
Symptoms: Viral infection, Vomiting
Clinical narrative: Initial raised and inflamed at site of injection.  By evening, low grade fever, sore throat, sore glands in throat, headache. Returned to Doctor on 06/23/2011.  Throat was swabbed for Strep (neg) and issued prescription for cephalexin 500mg.  Fever and throat swelling persisted until Sunday, 06/26/2011, when I couldn't swallow at all, 103 degree fever, swollen throat, and vomiting, pain in shoulder and chest.  Went to ER.  Cat Scan showed bacterial infection.  Given IVs of steroids and antibiotics.  Admitted to hospital Sunday 06/26/11, continued antibiotics and steroids.  Released Monday evening 06/27/2011 with prescription for Dexamethasone 4mg and Clindamycin HCL 150.  Throat seemed better. Low grade fever continued and by Thursday 06/30/2011 was back up to 102 degree.  Follow-up on Friday with Dr.  Told was getting better.  Fever and pain in shoulder and chest continues thru 07/05/2011, always around 102 degree.  Another Dr. Appointment.  Blood work taken and was told I had a viral infection of lymph nodes.  Treat fever.  Fever continues through Sat. 07/09/2011. Pain in shoulder and chest continues through 07/11/2011
Age: 64.0
Sex: F
Vaccine: VARZOS
Symptoms: Rash
Clinical narrative: On 6-29-11, received Zostavax. On 6-30-11, ct had rash on R arm, R shoulder back, R side of face, states taking Benadryl. Now 11:30 AM, rash is nearly gone.
Age: 21.0
Sex: F
Vaccine: HPV4, TDAP, HPV4, TDAP
Symptoms: Eye swelling, Swelling face
Clinical narrative: It started with just forehead swelling and as the weekend progressed my entire face swelled up.  My eye was swollen shut.
Age: 21.0
Sex: F
Vaccine: HPV4, TDAP, HPV4, TDAP
Symptoms: Allergy to vaccine, Eye swelling, Immediate post-injection reaction, Impaired driving ability, Incisional drainage
Clinical narrative: It started with just forehead swelling and as the weekend progressed my entire face swelled up.  My eye was swollen shut.
Age: 21.0
Sex: F
Vaccine: HPV4, TDAP, HPV4, TDAP
Symptoms: Swelling face
Clinical narrative: It started with just forehead swelling and as the weekend progressed my entire face swelled up.  My eye was swollen shut.
Age: 11.0
Sex: F
Vaccine: HPV4, MNQ, TDAP
Symptoms: Dizziness, Pallor, Posture abnormal
Clinical narrative: Patient became pale and lightheaded and slumped in her chair.
Age: 11.0
Sex: M
Vaccine: MNQ, TDAP
Symptoms: Erythema, Local reaction, Oedema, Pain
Clinical narrative: Localized skin/tissue reaction with erythema, mild edema and mild-mod pain.
Age: 23.0
Sex: M
Vaccine: SMALL
Symptoms: Echocardiogram, Electrocardiogram abnormal, Nuclear magnetic resonance imaging thoracic, Pericardial disease, Pericarditis
Clinical narrative: This study case was received from the investigator in a trial on 01 July 2011. A 23-year-old male subject, with no significant medical history, received an injection with ACAM2000, lot number not reported, on 04 February 2011. On 24 February 2011, the subject had an abnormal troponin I of 00.05, and an abnormal electrocardiogram (ECG). On 25 February 2011, the subject had an echocardiogram (results not provided). A magnetic resonance imaging (MRI) scan of the heart was performed (date not reported) but results were not available. On 25 February 2011, a diagnosis of unspecified disease of pericardium was made. On 02 March 2011, a diagnosis of acute pericarditis, unspecified was made. The outcome was not reported. Additional information will be requested from the investigator. Documents held by sender: None.
Age: 23.0
Sex: M
Vaccine: SMALL
Symptoms: Troponin I increased
Clinical narrative: This study case was received from the investigator in a trial on 01 July 2011. A 23-year-old male subject, with no significant medical history, received an injection with ACAM2000, lot number not reported, on 04 February 2011. On 24 February 2011, the subject had an abnormal troponin I of 00.05, and an abnormal electrocardiogram (ECG). On 25 February 2011, the subject had an echocardiogram (results not provided). A magnetic resonance imaging (MRI) scan of the heart was performed (date not reported) but results were not available. On 25 February 2011, a diagnosis of unspecified disease of pericardium was made. On 02 March 2011, a diagnosis of acute pericarditis, unspecified was made. The outcome was not reported. Additional information will be requested from the investigator. Documents held by sender: None.
Age: 1.25
Sex: F
Vaccine: DTAPIPVHIB, PNC
Symptoms: Injection site erythema, Injection site nodule
Clinical narrative: Red area about the size of a quarter on both legs (thighs), small knot on each leg as well.
Age: 23.0
Sex: M
Vaccine: SMALL
Symptoms: Echocardiogram normal, Electrocardiogram abnormal, Pericardial disease, Troponin I
Clinical narrative: This study case was received from the investigator in a trial on 01 July 2011. A 23-year-old male subject, with no significant medical history, received an injection with ACAM2000, lot number not reported, on 04 February 2011. On 22 February 2011, the subject had a normal troponin I, an abnormal electrocardiogram (ECG) and a normal echocardiogram. On 22 February 2011, a diagnosis of unspecified disease of pericardium was made. The outcome was not reported. Additional information will be requested from the investigator. Documents held by sender: None.
Age: 11.0
Sex: M
Vaccine: MNQ, TDAP, VARCEL
Symptoms: Fatigue, Headache, Injection site erythema, Injection site swelling, Oedema peripheral
Clinical narrative: Mother reported on 7-10-11 client c/o itching with swelling & hives to underarms bilaterally, arms, legs & top of (L) foot. Reports HA, tired with no fever. Appointment with PCP 7-11-11. PCP advised was reaction to MCV & instructed to take BENADRYL by mouth & prescribed generic DIPROLENE for areas of hives & itching. Injection site red & swollen.
Age: 11.0
Sex: M
Vaccine: MNQ, TDAP, VARCEL
Symptoms: Pruritus, Urticaria, Vaccination complication
Clinical narrative: Mother reported on 7-10-11 client c/o itching with swelling & hives to underarms bilaterally, arms, legs & top of (L) foot. Reports HA, tired with no fever. Appointment with PCP 7-11-11. PCP advised was reaction to MCV & instructed to take BENADRYL by mouth & prescribed generic DIPROLENE for areas of hives & itching. Injection site red & swollen.
Age: 61.0
Sex: F
Vaccine: VARZOS
Symptoms: Dyspnoea, Injection site erythema, Injection site pruritus, Injection site swelling, Injection site warmth
Clinical narrative: Monday got vaccine about 4pm fine right away & Mon Tues noticed some itching at site, breathing little stressed - used inhaler. Currently red/itchy/warm/swollen at site. Will take BENADRYL & inform Dr.
Age: 11.0
Sex: F
Vaccine: HPV4
Symptoms: Dizziness, Tremor
Clinical narrative: Mom said pt. had "passed out on last vaccine". So after giving 2nd HPV, I instruct pt. to laid down for a few minutes, she said she was ok but still she stay there resting for awhile. When she was walking out (in the lobby) mom states she was gonna "pass out" again, shake slightly.
Age: 59.0
Sex: F
Vaccine: TDAP
Symptoms: Abdominal discomfort, Diarrhoea, Fatigue, Oedema peripheral, Pain in extremity
Clinical narrative: Fatigue, stomach upset, diarrhea, & vomiting lasting one day. Arm sore, swollen, & warm to touch for 3-4 days. Clt. requested this be reported. She"never felt this way after receiving a vaccine".
Age: 59.0
Sex: F
Vaccine: TDAP
Symptoms: Skin warm, Vomiting
Clinical narrative: Fatigue, stomach upset, diarrhea, & vomiting lasting one day. Arm sore, swollen, & warm to touch for 3-4 days. Clt. requested this be reported. She"never felt this way after receiving a vaccine".
Age: 0.73
Sex: M
Vaccine: DTAPIPVHIB, HEP, PNC13
Symptoms: Pyrexia
Clinical narrative: Fever around 102 F.
Age: 46.0
Sex: F
Vaccine: HEP
Symptoms: Erythema, Fatigue, Headache, Pruritus, Throat irritation
Clinical narrative: Itching in scalp and back of arms starting approximately 1hours after vaccination, progressing to itching at throat and redden areas 4 hours later when it was reported to employee health nurse who had administered vaccine to this employee.  Given 25mg Benadryl on recommendation of nurse clinician onsite, sent home, and advised to follow up at hospital ED if symptoms persisted or worsened.  At follow up the next day at work site, employee states she did make an ER visit and was prescribed more Benadryl and Prednisolone.  States she feels much better, but has slight headache and feels fatigued.
Age: 18.0
Sex: F
Vaccine: HEP, MMR, MNQ, TDAP
Symptoms: Pain, Pyrexia, Rash generalised, Rash pruritic, Streptococcus test
Clinical narrative: 18 yo female previously not vaccinated, needed immuniz. for college, came into office and had Tdap, Hep B, MENACTRA and MMR administered (6/29/11). A few days later developed body aches and a fever at aprox 10d. after immunizations developed a head to toe rash which is itchy. No tongue/lip swelling, no wheezing/anaphylaxis symptoms.
Age: 18.0
Sex: F
Vaccine: HEP, MMR, MNQ, TDAP
Symptoms: Streptococcus test negative
Clinical narrative: 18 yo female previously not vaccinated, needed immuniz. for college, came into office and had Tdap, Hep B, MENACTRA and MMR administered (6/29/11). A few days later developed body aches and a fever at aprox 10d. after immunizations developed a head to toe rash which is itchy. No tongue/lip swelling, no wheezing/anaphylaxis symptoms.
Age: 5.0
Sex: M
Vaccine: MMR, VARCEL
Symptoms: Eye swelling, Sneezing
Clinical narrative: As per mother, patient began sneezing and having eye swelling.
Age: 4.0
Sex: M
Vaccine: DTAPIPV, MMR, VARCEL
Symptoms: Gait disturbance, Injection site pain, Injection site rash, Injection site swelling
Clinical narrative: As per mother, patient had a normal response to vaccine during first day. Yesterday child was refusing to walk, was limping favoring the right lower extemity. Today a rash and swelling of the thigh area was noticed. Patient states it hurts, but walks and runs. Mother was so concerned about an infectious cellulitis, that took child to ER.
Age: 1.01
Sex: F
Vaccine: HEPA, MMR, PNC13, VARCEL
Symptoms: Injection site urticaria, Urticaria
Clinical narrative: Hives head to toe minutes after injection. Worse right at varicella site. BENADRYL 12.5mg given, Prednisone 20 mg given. Hives resolved within 10 minutes.
Age: 1.57
Sex: M
Vaccine: HEPA, PNC
Symptoms: Injection site urticaria
Clinical narrative: Hives - localized (R) thigh. Triamcinolone cream.
Age: 5.0
Sex: M
Vaccine: DTAPIPV, MMR, VARCEL
Symptoms: Injection site pruritus, Injection site rash
Clinical narrative: Child developed pinpoint itchy rash to both upper extremities.
Age: 0.17
Sex: F
Vaccine: DTAPIPVHIB, HEP, PNC13, RV5
Symptoms: Convulsion, Gaze palsy, Muscle twitching
Clinical narrative: Awake on floor, then mom noticed eye rolling and head twitching such as seizure. Called pediatrician right away.
Age: 63.0
Sex: F
Vaccine: PPV
Symptoms: Vaccination site cellulitis
Clinical narrative: Cellulitis like reaction in right arm at sign of pneumococcal vaccination. Treated with steroids and Benadryl.
Age: 76.0
Sex: F
Vaccine: PPV
Symptoms: Erythema, Skin warm, Vaccination complication
Clinical narrative: Erythema and warmth in right arm consistent with a vaccine reaction. Treated with acetaminophen.
Age: 10.0
Sex: F
Vaccine: HPV4, MNQ
Symptoms: Injection site erythema, Injection site pain, Injection site swelling, Injection site warmth
Clinical narrative: RIGHT UPPER ARM RED AND SWOLLEN. AREA MEASURED  12.5 CM BY 13.5 CM. WARM, ERYTHEMA, MILD TENDERNESS. NO BRUISING.
Age: 2.0
Sex: M
Vaccine: DTAP
Symptoms: Injection site swelling
Clinical narrative: Swelling of the tissues surrounding injection site.
Age: 66.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site swelling, Injection site warmth
Clinical narrative: Swelling & warmth of upper arm around injection site. Self-treated with BENADRYL & ice. Symptoms resolved after approx 4 days.
Age: 11.0
Sex: M
Vaccine: MNQ, TDAP
Symptoms: Erythema, Oedema peripheral, Urticaria
Clinical narrative: Redness, swelling down arm, hives.
Age: 11.0
Sex: M
Vaccine: MNQ, TDAP
Symptoms: Erythema, Oedema peripheral, Urticaria
Clinical narrative: Redness, swelling down the arm, hives.
Age: 11.0
Sex: M
Vaccine: MNQ, TDAP
Symptoms: Erythema, Oedema peripheral, Urticaria
Clinical narrative: Hives, redness, swelling all the way down the arm.
Age: 12.0
Sex: F
Vaccine: HPV4, MNQ, TDAP
Symptoms: Fall, Feeling abnormal, Pallor, Syncope, Unresponsive to stimuli
Clinical narrative: Pt. was administered TDAP, MENACTRA, HPV. About 3 min. after, she became pale (white), slid down in chair - non responsive. Became responsive as ice was applied to forehead. Still dazed & pale. Said I fainted. She yawned many times. Tried to go to sleep. B/P 50/40. After eating crackers, she left 25 min. later with her mother.
Age: 12.0
Sex: F
Vaccine: HPV4, MNQ, TDAP
Symptoms: Yawning
Clinical narrative: Pt. was administered TDAP, MENACTRA, HPV. About 3 min. after, she became pale (white), slid down in chair - non responsive. Became responsive as ice was applied to forehead. Still dazed & pale. Said I fainted. She yawned many times. Tried to go to sleep. B/P 50/40. After eating crackers, she left 25 min. later with her mother.
Age: 1.08
Sex: M
Vaccine: DTAPIPVHIB, HEPA, PNC13, VARCEL
Symptoms: Expired drug administered, No adverse event
Clinical narrative: (None noted - adverse reaction). MMR vaccine expired 6/18/2011 but administered on 06/20/2011.
Age: 1.2
Sex: M
Vaccine: DTAPIPVHIB, PNC13, VARCEL
Symptoms: Expired drug administered, No adverse event
Clinical narrative: (None Noted - adverse reaction). MMR vaccine expired 6/18/2011 but administered on 06/20/2011.
Age: 1.18
Sex: F
Vaccine: VARCEL
Symptoms: Expired drug administered, No adverse event
Clinical narrative: (None noted - adverse reaction). MMR vaccine expired 6/18/2011 but administered on 06/20/2011.
Age: 2.0
Sex: F
Vaccine: TD
Symptoms: Injection site erythema, Skin induration, Skin swelling
Clinical narrative: Erythema, approx 2 inches in diameter around injection site. Hard swelling under skin.
Age: 0.15
Sex: F
Vaccine: 6VAX-F
Symptoms: Muscle spasms, Screaming
Clinical narrative: Baby screamed for over 3 hours, was told to monitor her breathing and keep an eye on her. 2 days later experienced what was later diagnosed as "muscle spasms".
Age: 69.0
Sex: F
Vaccine: VARZOS
Symptoms: Herpes zoster
Clinical narrative: PATIENT REPORTED THAT SHE HAD BEEN DIAGNOSED WITH SHINGLES AS A RESULT OF GETTING THE ZOSTAVAX VACCINE ON 6/20/11.  SHE CAME TO THE PHARMACY TO FILL AN ACYCLOVIR PRESCRIPTION TO TREAT THE SHINGLES.
Age: 45.0
Sex: M
Vaccine: TD
Symptoms: Mobility decreased, Musculoskeletal pain, Pain in extremity
Clinical narrative: Severe pain in rt. arm and shoulder, went to E.R., PA couldn't diagnose what was wrong. Went to Dr. the next day, still in severe pain, couldn't move arm. Dr. prescribed steroids and antibiotic.
Age: 1.07
Sex: F
Vaccine: DTAPIPVHIB, HEPA, MMR, PNC13, VARCEL
Symptoms: Injection site erythema, Injection site swelling, Pyrexia
Clinical narrative: redness and swelling on left leg and fevers
Age: 40.0
Sex: F
Vaccine: TDAP
Symptoms: Headache, Nausea, Oedema peripheral
Clinical narrative: nausea, headache, swollen arm