chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 1.59
Sex: M
Vaccine: DTAP, FLUX, HEPA, HIBV, PNC
Symptoms: Rash vesicular, White blood cell count normal
Clinical narrative: Maculo Papulo vesicular rash on vaccine administration site approximately 6 days post administration.  4/6/07 Received medical records from PCP which reveal patient experienced mild URI symptoms on 3/27/07 day of vax.  Vaccination record included. 5/4/07 Received medical records from hospital which reveal patient experienced erythematous rash w/pain & pruritis on left thigh & gluteus, macular vesicular apulae in appearance.  Admitted 4/3-4/5/07.  Tx w/IV antibiotics for initial cellulitis.  Dermatology & Allergology consults done.   Temp in hospital 102.9 FINAL DX: Herpes zoster left leg.
Age: 12.0
Sex: F
Vaccine: HPV4
Symptoms: Injection site pain, Neck pain, Paraesthesia
Clinical narrative: Pain from injection site extending into neck.  Paresthesia in hand.
Age: 31.0
Sex: F
Vaccine: SMALL
Symptoms: Culture negative, Rash papular, Rash vesicular, Skin lesion, Urticaria
Clinical narrative: Patient reported skin lesions on leg on 2/27/07-pink/red and scaly papules covering area of 3 cm x 3 cm of right lower leg and small papule on right lateral knee. No fever, no chills-no systemic signs and symptoms; On 3/5/07 evaluated by doctor-vesicular rash on right lower leg with drainage, right lateral knee lesion with drainage; Pt evaluated by doctor (3/6/07) and doctor (10) on 3/7/07. Vaccinia culture sent-(hives); supportive cane and off work for 7 days; dings to all lesions. Last flu date 3/20/07 lesion-no further vesicles. doctor contacted by doctor.
Age: 31.0
Sex: F
Vaccine: SMALL
Symptoms: Vaccinia, Wound drainage
Clinical narrative: Patient reported skin lesions on leg on 2/27/07-pink/red and scaly papules covering area of 3 cm x 3 cm of right lower leg and small papule on right lateral knee. No fever, no chills-no systemic signs and symptoms; On 3/5/07 evaluated by doctor-vesicular rash on right lower leg with drainage, right lateral knee lesion with drainage; Pt evaluated by doctor (3/6/07) and doctor (10) on 3/7/07. Vaccinia culture sent-(hives); supportive cane and off work for 7 days; dings to all lesions. Last flu date 3/20/07 lesion-no further vesicles. doctor contacted by doctor.
Age: 62.0
Sex: F
Vaccine: TDAP
Symptoms: Injection site erythema
Clinical narrative: Localized redness in R deltoid injection site, first aid, warm compresses
Age: 38.0
Sex: F
Vaccine: TDAP
Symptoms: Injection site erythema, Injection site pain, Injection site warmth
Clinical narrative: R deltoid injection site, sore, tender radiation to neck, warm to the touch, redness. S/B ER MD prescription for steroids/prednisone.
Age: 17.0
Sex: F
Vaccine: HEPA, HPV4, MNQ
Symptoms: Asthenia, Hypotonia, Muscular weakness, Pain in extremity
Clinical narrative: Pt c/o pain and weakness in Lt arm persistent since admin. of vaccine in Lt arm. Dr notes pt has decrease muscle strength in Lt arm unable to make a fist and decrease tone in Lt arm.  4/10/07 Received medical records from PCP which include vax records & reveal that on day of vax patient experienced UTI s/s, UA was done & patient started on antibiotics.  Returned to PCP on 4/4/07 w/complaints of left arm weakness since vax.  Exam revealed decreased left arm muscle strength.  Patient was unable to make a fist w/left hand & had decreased muscle tone in left arm.  Received neuro & PT referrals.
Sex: F
Vaccine: HEPA, HPV4, MNQ, VARCEL
Symptoms: Inappropriate schedule of drug administration, Injection site erythema, Injection site swelling, Oedema peripheral
Clinical narrative: Right upper arm swelled and turned red. Was given on ABD, steroid and pain killer about Fri PM 13/30/07. Seen again by NP - no meds given at that time. Arm by 4-1-07was red and swollen from elbow elbow to shoulder and was resolving.
Age: 4.0
Sex: F
Vaccine: DTAP, IPV, MMRV
Symptoms: Injection site erythema, Injection site swelling, Injection site warmth
Clinical narrative: Warm to touch at Left Deltoid Red, Swollen with no complaints of pain. Treatment=Benadryl.
Age: 0.17
Sex: M
Vaccine: DTAPHEPBIP, HIBV, PNC, RV5
Symptoms: Abdominal X-ray, Bowel sounds abnormal, Dehydration, Diarrhoea, Irritability
Clinical narrative: 3/16 diarrhea thru to presented 3/20 after much less po and no vax 12+ hours and one mucousy large bowel movement and irritable and rash on buttock. Physical exam with full abdomen with decreased bowel sounds but soft. Abdominal series xray decreased gas but WNL, no fever, mild dehydration. Will follow up on Pedialyte
Age: 0.17
Sex: M
Vaccine: DTAPHEPBIP, HIBV, PNC, RV5
Symptoms: Mucous stools, Rash
Clinical narrative: 3/16 diarrhea thru to presented 3/20 after much less po and no vax 12+ hours and one mucousy large bowel movement and irritable and rash on buttock. Physical exam with full abdomen with decreased bowel sounds but soft. Abdominal series xray decreased gas but WNL, no fever, mild dehydration. Will follow up on Pedialyte
Age: 1.5
Sex: M
Vaccine: HEPA
Symptoms: Bladder obstruction, Body temperature increased, Chest X-ray, Fatigue, Full blood count
Clinical narrative: 6:00 pm tired, vomiting-temp of 104 deg at 8:15 pm. Vomited 5 times-taken to ER. received IV fluids.
Age: 1.5
Sex: M
Vaccine: HEPA
Symptoms: Vomiting, White blood cell count increased
Clinical narrative: 6:00 pm tired, vomiting-temp of 104 deg at 8:15 pm. Vomited 5 times-taken to ER. received IV fluids.
Age: 4.0
Sex: F
Vaccine: DTAP, MMR, OPV
Symptoms: Injection site rash, Injection site vesicles, Pyrexia
Clinical narrative: rash, blisters, fever around injection site, - pt treated with antibiotics
Age: 0.37
Sex: M
Vaccine: DTAP, HEP, HIBV, IPV, PNC, RV5, RV5, DTAP, HEP, HIBV, IPV, PNC, RV5
Symptoms: Grand mal convulsion, Pyrexia
Clinical narrative: Initial report received on 22 March 2007 from another manufacturer, report number WAES0702USA03944. The initial reporter to this manufacturer had been a health care professional. Verbatim from the report: "Information has been received from a physician concerning a 19-week-old male on 16-Nov-2006 and 18-Jan-2007 (1130) was vaccinated PO with the first and second 2.0 mL doses, respectively, of Rotateq (lot# 654663/0942F). Illness at the time of vaccination included bronchiolitis (with cough and wheezing), chronic purulent otitis media, URI, and pharyngitis. Concomitant vaccinations administered on 18-Jan-2007 at 1130 included the second SC dose in the right leg of IPOL (Lot# 70240), the second IM dose in the left leg of Daptacel (lot# C2552AA), the second IM dose in the left leg of ActHib (lot# UE993AA), the second IM dose in the right leg of Energix-B (lot# AHBVB194AA), and the second IM dose in the right leg of Prevnar (lot# B36258A). Other concomitant drug therapy included Pulmicort, Tylenol, Dimetapp and albuterol. The physician reported that on 18-Jan-2007, the patient developed a fever and had a tonic-clonic seizure. The patient was seen in the emergency room (ER) where a full sepsis work-up was performed (results not provided). The patient was subsequently hospitalized (length unspecified). At the time of this report, the outcome was unknown. Additional follow-up information indicated that the patient developed a fever of 100.0. At that time, the patient was almost recovered from an episode of bronchiolitis with otitis media and pharyngitis diagnosed on 03-Jan-2007. The patient was still taking albuterol and budesonide nebulizers, acetaminophen and brompheniramine maleate + pseudoephedrine as he had developed a new cold. Upon examination, it was noted the patient's ear infection was not completely resolved and he had a cough. The patient did not appear ill and was in good spirits. On the evening of 19-Jan-2007, the patient developed a tonic-clonic seizure and had been transported to an ER where a full sepsis work-up was performed. The patient was referred to a hospital for admission and observation. At the time of this report, the patient's current status was not exactly known. Additional information has been requested." The patient had received ActHib, lot number UE993AA, (manufacturer lot number Z07575-2).
Age: 0.37
Sex: M
Vaccine: DTAP, HEP, HIBV, IPV, PNC, RV5, RV5, DTAP, HEP, HIBV, IPV, PNC, RV5
Symptoms: Body temperature increased, Grand mal convulsion, Laboratory test, Nasopharyngitis, Pyrexia
Clinical narrative: Initial report received on 22 March 2007 from another manufacturer, report number WAES0702USA03944. The initial reporter to this manufacturer had been a health care professional. Verbatim from the report: "Information has been received from a physician concerning a 19-week-old male on 16-Nov-2006 and 18-Jan-2007 (1130) was vaccinated PO with the first and second 2.0 mL doses, respectively, of Rotateq (lot# 654663/0942F). Illness at the time of vaccination included bronchiolitis (with cough and wheezing), chronic purulent otitis media, URI, and pharyngitis. Concomitant vaccinations administered on 18-Jan-2007 at 1130 included the second SC dose in the right leg of IPOL (Lot# 70240), the second IM dose in the left leg of Daptacel (lot# C2552AA), the second IM dose in the left leg of ActHib (lot# UE993AA), the second IM dose in the right leg of Energix-B (lot# AHBVB194AA), and the second IM dose in the right leg of Prevnar (lot# B36258A). Other concomitant drug therapy included Pulmicort, Tylenol, Dimetapp and albuterol. The physician reported that on 18-Jan-2007, the patient developed a fever and had a tonic-clonic seizure. The patient was seen in the emergency room (ER) where a full sepsis work-up was performed (results not provided). The patient was subsequently hospitalized (length unspecified). At the time of this report, the outcome was unknown. Additional follow-up information indicated that the patient developed a fever of 100.0. At that time, the patient was almost recovered from an episode of bronchiolitis with otitis media and pharyngitis diagnosed on 03-Jan-2007. The patient was still taking albuterol and budesonide nebulizers, acetaminophen and brompheniramine maleate + pseudoephedrine as he had developed a new cold. Upon examination, it was noted the patient's ear infection was not completely resolved and he had a cough. The patient did not appear ill and was in good spirits. On the evening of 19-Jan-2007, the patient developed a tonic-clonic seizure and had been transported to an ER where a full sepsis work-up was performed. The patient was referred to a hospital for admission and observation. At the time of this report, the patient's current status was not exactly known. Additional information has been requested." The patient had received ActHib, lot number UE993AA, (manufacturer lot number Z07575-2).
Age: 0.37
Sex: M
Vaccine: DTAP, HEP, HIBV, IPV, PNC, RV5, RV5, DTAP, HEP, HIBV, IPV, PNC, RV5
Symptoms: Sepsis
Clinical narrative: Initial report received on 22 March 2007 from another manufacturer, report number WAES0702USA03944. The initial reporter to this manufacturer had been a health care professional. Verbatim from the report: "Information has been received from a physician concerning a 19-week-old male on 16-Nov-2006 and 18-Jan-2007 (1130) was vaccinated PO with the first and second 2.0 mL doses, respectively, of Rotateq (lot# 654663/0942F). Illness at the time of vaccination included bronchiolitis (with cough and wheezing), chronic purulent otitis media, URI, and pharyngitis. Concomitant vaccinations administered on 18-Jan-2007 at 1130 included the second SC dose in the right leg of IPOL (Lot# 70240), the second IM dose in the left leg of Daptacel (lot# C2552AA), the second IM dose in the left leg of ActHib (lot# UE993AA), the second IM dose in the right leg of Energix-B (lot# AHBVB194AA), and the second IM dose in the right leg of Prevnar (lot# B36258A). Other concomitant drug therapy included Pulmicort, Tylenol, Dimetapp and albuterol. The physician reported that on 18-Jan-2007, the patient developed a fever and had a tonic-clonic seizure. The patient was seen in the emergency room (ER) where a full sepsis work-up was performed (results not provided). The patient was subsequently hospitalized (length unspecified). At the time of this report, the outcome was unknown. Additional follow-up information indicated that the patient developed a fever of 100.0. At that time, the patient was almost recovered from an episode of bronchiolitis with otitis media and pharyngitis diagnosed on 03-Jan-2007. The patient was still taking albuterol and budesonide nebulizers, acetaminophen and brompheniramine maleate + pseudoephedrine as he had developed a new cold. Upon examination, it was noted the patient's ear infection was not completely resolved and he had a cough. The patient did not appear ill and was in good spirits. On the evening of 19-Jan-2007, the patient developed a tonic-clonic seizure and had been transported to an ER where a full sepsis work-up was performed. The patient was referred to a hospital for admission and observation. At the time of this report, the patient's current status was not exactly known. Additional information has been requested." The patient had received ActHib, lot number UE993AA, (manufacturer lot number Z07575-2).
Age: 0.75
Sex: F
Vaccine: DTAPHEPBIP, HIBV, PNC, RV5, DTAPHEPBIP, HIBV, PNC, RV5
Symptoms: Computerised tomogram, Intussusception, Ultrasound scan, X-ray
Clinical narrative: Information has been received concerning a 10 month old female, with no medical history and no allergies, who on 16-JAN-2007 was vaccinated with a dose of Rotateq (Lot# 655867/1111F). Concomitant vaccines administered on the same day included a second dose in the right upper leg of PEDIARIX (Lot# AC21B084CA), a second dose in the left upper leg of PedvaxHib (Lot# 654910/1270F) and a second dose in the left upper leg of PREVNAR (Lot# B47442A). There were no other concomitant medications. There was no illness at the time of vaccination. On 19-FEB-2007 the patient experienced intussusception in the right lower quadrant and was hospitalized for two days. The patient's recovery status was reported as unknown. A lot check was requested. The records of testing prior to release of the lot in question has been rechecked and found to be satisfactory. The lot met the requirements and was released. Additional information has been requested.
Age: 0.75
Sex: F
Vaccine: DTAPHEPBIP, HIBV, PNC, RV5, DTAPHEPBIP, HIBV, PNC, RV5
Symptoms: Computerised tomogram, Inappropriate schedule of drug administration, Intussusception, Ultrasound scan, X-ray
Clinical narrative: Information has been received concerning a 10 month old female, with no medical history and no allergies, who on 16-JAN-2007 was vaccinated with a dose of Rotateq (Lot# 655867/1111F). Concomitant vaccines administered on the same day included a second dose in the right upper leg of PEDIARIX (Lot# AC21B084CA), a second dose in the left upper leg of PedvaxHib (Lot# 654910/1270F) and a second dose in the left upper leg of PREVNAR (Lot# B47442A). There were no other concomitant medications. There was no illness at the time of vaccination. On 19-FEB-2007 the patient experienced intussusception in the right lower quadrant and was hospitalized for two days. The patient's recovery status was reported as unknown. A lot check was requested. The records of testing prior to release of the lot in question has been rechecked and found to be satisfactory. The lot met the requirements and was released. Additional information has been requested.
Age: 0.34
Sex: M
Vaccine: RV5, DTAP, HIBV, PNC, RV5
Symptoms: Intestinal resection, Intussusception
Clinical narrative: Initial report receive on 22 March 2007 from another manufacturer, report number WAES0702USA04331. The initial reporter to this manufacturer had been a health care professional. Verbatim from the report: "Information has been received from a physician concerning a 22 week old male, with a history of respiratory distress at birth, who was vaccinated with a first and second dose of Rotateq and on 28-Nov-2006 (lot# 654969/1016F) and 16-Jan-2007 (lot# 655082/0779F), respectively. Concomitant vaccines administered on 28-Nov-2006 included a dose of Dtap, Prevnar, Hib vaccine (manufacturer unknown), a dose of Ipol and a dose of Hepatitis B (manufacturer unknown). Concomitant vaccines administered on 16-Jan-2007 included a dose of Dtap, Prevnar, and a dose of PedvaxHib (Manufacturer unknown). On the evening of 22-Feb-2007 the patient experienced intussusception. No product quality complaint was involved. The route of administration was recorded as "injection" (further clarification is pending). Follow-up information from a physician indicated that the patient was admitted to the hospital on 21-Feb-2007 with intussusception that required a bowel resection. Subsequently the patient recovered. Lot checks have been requested. Additional information is not expected.
Age: 15.0
Sex: F
Vaccine: HPV4, MNQ, HPV4, MNQ, HPV4, MNQ
Symptoms: Blood glucose normal, CSF test normal, Chest X-ray normal, Full blood count normal, Headache
Clinical narrative: Initial report received on 28 March 2007 from an other manufacturer, reference number WAES 0703USA03222. The initial reporter to the other manufacturer was a health care professional. This is a verbatim copy of the report from the other manufacturer. "Information has been received from a Nurse Practitioner concerning a 15 year old female patient with asthma who on 28-FEB-2007 was vaccinated with a dose of Gardasil, lot # 654535/0960F. Concomitant suspect therapy included MENACTRA, administered on the same day. Other concomitant therapy included ADVAIR. ON 05-Mar-2007 the patient was diagnosed with Guillain-Barre syndrome. Her outcome was not reported. The reporter felt that Guillain-Barre syndrome was a result of MENACTRA, and not Gardasil. Upon internal review, Guillain-Barre syndrome was considered to be an other important medical event. Additional information has been requested." The information received included a VAERS ID #. This case is being evaluated by CISA (Clinical immunization Safety Assessment network) and has not yet been confirmed.
Age: 15.0
Sex: F
Vaccine: HPV4, MNQ, HPV4, MNQ, HPV4, MNQ
Symptoms: Hypoaesthesia, Hypokinesia, Hyporeflexia, Malaise, Pyrexia
Clinical narrative: Initial report received on 28 March 2007 from an other manufacturer, reference number WAES 0703USA03222. The initial reporter to the other manufacturer was a health care professional. This is a verbatim copy of the report from the other manufacturer. "Information has been received from a Nurse Practitioner concerning a 15 year old female patient with asthma who on 28-FEB-2007 was vaccinated with a dose of Gardasil, lot # 654535/0960F. Concomitant suspect therapy included MENACTRA, administered on the same day. Other concomitant therapy included ADVAIR. ON 05-Mar-2007 the patient was diagnosed with Guillain-Barre syndrome. Her outcome was not reported. The reporter felt that Guillain-Barre syndrome was a result of MENACTRA, and not Gardasil. Upon internal review, Guillain-Barre syndrome was considered to be an other important medical event. Additional information has been requested." The information received included a VAERS ID #. This case is being evaluated by CISA (Clinical immunization Safety Assessment network) and has not yet been confirmed.
Age: 15.0
Sex: F
Vaccine: HPV4, MNQ, HPV4, MNQ, HPV4, MNQ
Symptoms: Tremor, Urine analysis normal, Vomiting
Clinical narrative: Initial report received on 28 March 2007 from an other manufacturer, reference number WAES 0703USA03222. The initial reporter to the other manufacturer was a health care professional. This is a verbatim copy of the report from the other manufacturer. "Information has been received from a Nurse Practitioner concerning a 15 year old female patient with asthma who on 28-FEB-2007 was vaccinated with a dose of Gardasil, lot # 654535/0960F. Concomitant suspect therapy included MENACTRA, administered on the same day. Other concomitant therapy included ADVAIR. ON 05-Mar-2007 the patient was diagnosed with Guillain-Barre syndrome. Her outcome was not reported. The reporter felt that Guillain-Barre syndrome was a result of MENACTRA, and not Gardasil. Upon internal review, Guillain-Barre syndrome was considered to be an other important medical event. Additional information has been requested." The information received included a VAERS ID #. This case is being evaluated by CISA (Clinical immunization Safety Assessment network) and has not yet been confirmed.
Age: 15.0
Sex: F
Vaccine: HPV4, MNQ, HPV4, MNQ, HPV4, MNQ
Symptoms: Guillain-Barre syndrome
Clinical narrative: Initial report received on 28 March 2007 from an other manufacturer, reference number WAES 0703USA03222. The initial reporter to the other manufacturer was a health care professional. This is a verbatim copy of the report from the other manufacturer. "Information has been received from a Nurse Practitioner concerning a 15 year old female patient with asthma who on 28-FEB-2007 was vaccinated with a dose of Gardasil, lot # 654535/0960F. Concomitant suspect therapy included MENACTRA, administered on the same day. Other concomitant therapy included ADVAIR. ON 05-Mar-2007 the patient was diagnosed with Guillain-Barre syndrome. Her outcome was not reported. The reporter felt that Guillain-Barre syndrome was a result of MENACTRA, and not Gardasil. Upon internal review, Guillain-Barre syndrome was considered to be an other important medical event. Additional information has been requested." The information received included a VAERS ID #. This case is being evaluated by CISA (Clinical immunization Safety Assessment network) and has not yet been confirmed.
Age: 0.42
Sex: F
Vaccine: DTAP, HIBV, IPV, RV5, DTAP, HIBV, IPV, PNC, RV5
Symptoms: Abdominal pain, Barium double contrast, Constipation, Diarrhoea, Gastroenteritis rotavirus
Clinical narrative: Initial report received on 22 March 2007 from another manufacturer, report number WAES0703USA01485. The initial reporter to this manufacturer had been a health care professional. Verbatim from the report: "Information has been received from a health professional concerning a 6 month old female, with no medical history and no allergies, who was vaccinated with a first and second 2ml oral dose of Rotateq on 19-Oct-2006 and 17-Jan-2007 (lot# 655866/1110F), respectively. Concomitant vaccines administered on 17-Jan-2007 included a dose of Dtap, a dose of IPOL, a dose of PedvaxHib (manufacturer unknown) and a dose of Prevnar. It was reported that , according to the hospital discharge summary, 24 hours prior to presentation at the hospital, on 07-Mar-2007, the patient began with nausea, vomiting, abdominal pain, and constipation. The patient was admitted to the hospital on 08-Mar-2007 and had episodes of vomiting, diarrhea, and bloody stools. The patient was diagnosed with ileocolic intussusception, which was initially encountered in the distal transverse colon. It was also noted by the physician on the discharge summary that the patient had rotavirus. The patient was discharged on 10-Mar-2007 and had recovered. The patient's intussusception and rotavirus were considered to be other important medical events by the reporter. A lot check has been requested. Additional information has been requested.
Age: 0.42
Sex: F
Vaccine: DTAP, HIBV, IPV, RV5, DTAP, HIBV, IPV, PNC, RV5
Symptoms: Haematochezia, Intussusception, Nausea, Vomiting
Clinical narrative: Initial report received on 22 March 2007 from another manufacturer, report number WAES0703USA01485. The initial reporter to this manufacturer had been a health care professional. Verbatim from the report: "Information has been received from a health professional concerning a 6 month old female, with no medical history and no allergies, who was vaccinated with a first and second 2ml oral dose of Rotateq on 19-Oct-2006 and 17-Jan-2007 (lot# 655866/1110F), respectively. Concomitant vaccines administered on 17-Jan-2007 included a dose of Dtap, a dose of IPOL, a dose of PedvaxHib (manufacturer unknown) and a dose of Prevnar. It was reported that , according to the hospital discharge summary, 24 hours prior to presentation at the hospital, on 07-Mar-2007, the patient began with nausea, vomiting, abdominal pain, and constipation. The patient was admitted to the hospital on 08-Mar-2007 and had episodes of vomiting, diarrhea, and bloody stools. The patient was diagnosed with ileocolic intussusception, which was initially encountered in the distal transverse colon. It was also noted by the physician on the discharge summary that the patient had rotavirus. The patient was discharged on 10-Mar-2007 and had recovered. The patient's intussusception and rotavirus were considered to be other important medical events by the reporter. A lot check has been requested. Additional information has been requested.
Age: 22.0
Sex: F
Vaccine: RAB
Symptoms: Asthenia, Dizziness, Fatigue, Headache, Injection site pain
Clinical narrative: SEVERE PAIN FROM SHOT SITE TO TIPS OF FINGERS LIKE SOMETHING BREAKING AND RIPPING THROUGH MY ARM RIGHT AFTER VACCINE GIVEN FOR AN HOUR, SLIGHT STIFFNESS IN NECK WITH LEFT ARM SORE (GIVEN 2ND VACCINE IN RIGHT) SORENESS GOES AWAY FOR 4-5DAYS THEN LEFT ARM IS PAINFUL WITH PRESSURE APPLIED AT TOP OF ARM 2 DAYS LATER HEADACHES BEGAN AGAIN. SINCE FIRST ROUND OF VACCINE GIVEN I HAVE HAD WEAKNESS, LIGHTHEADEDNESS, HEADACHES, NAUSEA, AND FATIGUE USUALLY AFTER A COUPLE HOURS AFTER BEING AWAKE. SHOULDER MUSCLE IN NECK IS ALSO CONSTANTLY TIGHT AND PAINFUL. I DID NOT HAVE THESE SYMPTOMS BEFORE I STARTED THIS SERIES OF VACCINATIONS. I CONTINUED TAKING THE MEDS I WAS GIVEN FROM THE FIRST TIME BECAUSE THE DOCTORS DID NOT BELIEVE ME WHEN I WENT IN ON 3/3/07 AND 3/5/07. I STILL HAVE PAIN WHERE I HAVE TO TAKE MEDICINE FOR IT DAILY.
Age: 22.0
Sex: F
Vaccine: RAB
Symptoms: Musculoskeletal pain, Musculoskeletal stiffness, Nausea, Neck pain, Pain in extremity
Clinical narrative: SEVERE PAIN FROM SHOT SITE TO TIPS OF FINGERS LIKE SOMETHING BREAKING AND RIPPING THROUGH MY ARM RIGHT AFTER VACCINE GIVEN FOR AN HOUR, SLIGHT STIFFNESS IN NECK WITH LEFT ARM SORE (GIVEN 2ND VACCINE IN RIGHT) SORENESS GOES AWAY FOR 4-5DAYS THEN LEFT ARM IS PAINFUL WITH PRESSURE APPLIED AT TOP OF ARM 2 DAYS LATER HEADACHES BEGAN AGAIN. SINCE FIRST ROUND OF VACCINE GIVEN I HAVE HAD WEAKNESS, LIGHTHEADEDNESS, HEADACHES, NAUSEA, AND FATIGUE USUALLY AFTER A COUPLE HOURS AFTER BEING AWAKE. SHOULDER MUSCLE IN NECK IS ALSO CONSTANTLY TIGHT AND PAINFUL. I DID NOT HAVE THESE SYMPTOMS BEFORE I STARTED THIS SERIES OF VACCINATIONS. I CONTINUED TAKING THE MEDS I WAS GIVEN FROM THE FIRST TIME BECAUSE THE DOCTORS DID NOT BELIEVE ME WHEN I WENT IN ON 3/3/07 AND 3/5/07. I STILL HAVE PAIN WHERE I HAVE TO TAKE MEDICINE FOR IT DAILY.
Age: 29.0
Sex: F
Vaccine: TYP
Symptoms: Abdominal pain, Diarrhoea
Clinical narrative: Severe abdominal pain/cramp few hours after taking each dose.  It lasts for about 24 hours.  Loose stool frequently for the immediate 24 hours after taking the pill.
Age: 0.33
Sex: M
Vaccine: DTAP, HIBV, IPV, PNC
Symptoms: Crying, Decreased appetite, Full blood count, Irritability, Lymphocyte count normal
Clinical narrative: No problem 1st set immun. fever 1 day elevated 102, decreased appetite, fluids and solids. Consolable when held, otherwise cranky and cries. Vomited x 2
Age: 0.33
Sex: M
Vaccine: DTAP, HIBV, IPV, PNC
Symptoms: Pyrexia, Vomiting, White blood cell count
Clinical narrative: No problem 1st set immun. fever 1 day elevated 102, decreased appetite, fluids and solids. Consolable when held, otherwise cranky and cries. Vomited x 2
Sex: F
Vaccine: HPV4
Symptoms: Convulsion
Clinical narrative: Information has been received from a medical office receptionist who saw a news report in which it was reported that a female patient who was vaccinated with Gardasil experienced a seizure. She had no further information and reported she only saw part of the news report. Upon internal review, seizure was considered an other important medical event. Additional information has been requested.
Age: 24.0
Sex: F
Vaccine: HPV4
Symptoms: Drug exposure during pregnancy, Foetal heart rate abnormal
Clinical narrative: Information has been received from a 24 year old female with no drug reactions or allergies and no pertinent medical history who on 07-FEB-2007 was vaccinated with the first dose of Gardasil. There was no concomitant medication. The patient reported that she was pregnant when she received her first injection of Gardasil. The patient reported that she did have an appointment with OB/GYN and the physician did not hear a heartbeat and she was therefore being referred for an ultrasound. The patient stated that her physician advised her to continue the injections with Gardasil, but the patient decided not to get the other two shots. Upon internal review it was determined that "physician did not hear a heartbeat" was considered an other important medical event. Additional information has been requested.
Age: 13.0
Sex: F
Vaccine: HPV4, HPV4
Symptoms: Arthralgia, Dizziness, Headache, Laboratory test, Loss of consciousness
Clinical narrative: Information has been received from a physician concerning a 13 year old female who on 18-DEC-2006 was vaccinated with a first dose of Gardasil (lot #654389/0961F). There was no concomitant medication. Subsequently, the patient experienced hip, knee and ankle pain. In January 2007, the patient began to experience occasional episodes of blurry vision. On 02-FEB-2007, the patient was vaccinated with a second dose of Gardasil. It was reported that the patient's symptoms "severely worsened" following the second dose of Gardasil and the patient also experienced lightheadedness and increase in headaches. The patient was seen by an orthopedic physician on 02-FEB-2007. Unspecified laboratory and diagnostic tests were performed (results not reported). On 07-FEB-2007 the patient experienced "one episode of blacking out." The patient saw a neurologist on 20-MAR-2007. At the time of the report, the patient had not recovered. The reporting physician considered the events to be disabling as the patient was unable to participate in ballet or dancing classes. Additional information has been requested.
Age: 13.0
Sex: F
Vaccine: HPV4, HPV4
Symptoms: Vision blurred
Clinical narrative: Information has been received from a physician concerning a 13 year old female who on 18-DEC-2006 was vaccinated with a first dose of Gardasil (lot #654389/0961F). There was no concomitant medication. Subsequently, the patient experienced hip, knee and ankle pain. In January 2007, the patient began to experience occasional episodes of blurry vision. On 02-FEB-2007, the patient was vaccinated with a second dose of Gardasil. It was reported that the patient's symptoms "severely worsened" following the second dose of Gardasil and the patient also experienced lightheadedness and increase in headaches. The patient was seen by an orthopedic physician on 02-FEB-2007. Unspecified laboratory and diagnostic tests were performed (results not reported). On 07-FEB-2007 the patient experienced "one episode of blacking out." The patient saw a neurologist on 20-MAR-2007. At the time of the report, the patient had not recovered. The reporting physician considered the events to be disabling as the patient was unable to participate in ballet or dancing classes. Additional information has been requested.
Age: 13.0
Sex: F
Vaccine: HPV4, HPV4
Symptoms: Arthralgia, Blood test normal, Dizziness, Groin pain, Headache
Clinical narrative: Information has been received from a physician concerning a 13 year old female who on 18-DEC-2006 was vaccinated with a first dose of Gardasil (lot #654389/0961F). There was no concomitant medication. Subsequently, the patient experienced hip, knee and ankle pain. In January 2007, the patient began to experience occasional episodes of blurry vision. On 02-FEB-2007, the patient was vaccinated with a second dose of Gardasil. It was reported that the patient's symptoms "severely worsened" following the second dose of Gardasil and the patient also experienced lightheadedness and increase in headaches. The patient was seen by an orthopedic physician on 02-FEB-2007. Unspecified laboratory and diagnostic tests were performed (results not reported). On 07-FEB-2007 the patient experienced "one episode of blacking out." The patient saw a neurologist on 20-MAR-2007. At the time of the report, the patient had not recovered. The reporting physician considered the events to be disabling as the patient was unable to participate in ballet or dancing classes. Additional information has been requested.
Age: 13.0
Sex: F
Vaccine: HPV4, HPV4
Symptoms: Loss of consciousness, Pain, Physiotherapy, Vision blurred, X-ray limb normal
Clinical narrative: Information has been received from a physician concerning a 13 year old female who on 18-DEC-2006 was vaccinated with a first dose of Gardasil (lot #654389/0961F). There was no concomitant medication. Subsequently, the patient experienced hip, knee and ankle pain. In January 2007, the patient began to experience occasional episodes of blurry vision. On 02-FEB-2007, the patient was vaccinated with a second dose of Gardasil. It was reported that the patient's symptoms "severely worsened" following the second dose of Gardasil and the patient also experienced lightheadedness and increase in headaches. The patient was seen by an orthopedic physician on 02-FEB-2007. Unspecified laboratory and diagnostic tests were performed (results not reported). On 07-FEB-2007 the patient experienced "one episode of blacking out." The patient saw a neurologist on 20-MAR-2007. At the time of the report, the patient had not recovered. The reporting physician considered the events to be disabling as the patient was unable to participate in ballet or dancing classes. Additional information has been requested.
Age: 13.0
Sex: F
Vaccine: HPV4, HPV4
Symptoms: X-ray normal, X-ray of pelvis and hip normal
Clinical narrative: Information has been received from a physician concerning a 13 year old female who on 18-DEC-2006 was vaccinated with a first dose of Gardasil (lot #654389/0961F). There was no concomitant medication. Subsequently, the patient experienced hip, knee and ankle pain. In January 2007, the patient began to experience occasional episodes of blurry vision. On 02-FEB-2007, the patient was vaccinated with a second dose of Gardasil. It was reported that the patient's symptoms "severely worsened" following the second dose of Gardasil and the patient also experienced lightheadedness and increase in headaches. The patient was seen by an orthopedic physician on 02-FEB-2007. Unspecified laboratory and diagnostic tests were performed (results not reported). On 07-FEB-2007 the patient experienced "one episode of blacking out." The patient saw a neurologist on 20-MAR-2007. At the time of the report, the patient had not recovered. The reporting physician considered the events to be disabling as the patient was unable to participate in ballet or dancing classes. Additional information has been requested.
Age: 52.0
Sex: M
Vaccine: PPV, TTOX
Symptoms: Headache, Injection site erythema, Injection site pain, Injection site warmth, Musculoskeletal stiffness
Clinical narrative: Information has been received from a licensed practical nurse concerning a 52 year old male who on 13-MAR-2007 was vaccinated into the right deltoid muscle with a first dose of Pneumovax (Lot# 651406/0620F). Concomitant suspect therapy included tetanus toxoid, administered into the left deltoid. There was no illness at the time of vaccination. On 15-MAR-2007, the patient developed pain in the left deltoid at the injection site where the tetanus was administered. The nurse reported that the patient's pain radiated from the left deltoid up to the neck. The area was red and warm. It was also reported that the patient came to the clinic on 15-MAR-2007 complaining of a headache and stiff neck. The patient was reported as recovered on 15-MAR-2007. The nurse felt that the patient's experiences were important medical events. Additional information has been requested.
Age: 52.0
Sex: M
Vaccine: PPV, TTOX
Symptoms: Neck pain
Clinical narrative: Information has been received from a licensed practical nurse concerning a 52 year old male who on 13-MAR-2007 was vaccinated into the right deltoid muscle with a first dose of Pneumovax (Lot# 651406/0620F). Concomitant suspect therapy included tetanus toxoid, administered into the left deltoid. There was no illness at the time of vaccination. On 15-MAR-2007, the patient developed pain in the left deltoid at the injection site where the tetanus was administered. The nurse reported that the patient's pain radiated from the left deltoid up to the neck. The area was red and warm. It was also reported that the patient came to the clinic on 15-MAR-2007 complaining of a headache and stiff neck. The patient was reported as recovered on 15-MAR-2007. The nurse felt that the patient's experiences were important medical events. Additional information has been requested.
Age: 76.0
Sex: M
Vaccine: VARZOS
Symptoms: Arachnoid cyst, Blood test normal, CSF glucose, CSF lymphocyte count, CSF mononuclear cell count increased
Clinical narrative: Information has been received from a physician concerning a 75 year old male with no known history who on 02-MAR-2007 was vaccinated SC in the left deltoid with a 0.65 ml first dose of Zostavax (lot # 652925/0621F). There was no concomitant medication or illness at the time of vaccination. Two hours after vaccination on 02-MAR-2007, the patient started developing pain in his neck as well as some achiness. He developed some disorientation and erratic driving over the weekend and was seen by the physician on 05-MAR-2007. The physician recommended work-up for possible Zostavax related meningoencephalitis or viral encephalitis. He was admitted to the hospital observation unit and under went neurological consultation. A MRA of the brain showed no acute infarct, no MRA evidence of encephalitis or meningitis. A 13 mm right medical posterior inferior cerebellar cystic lesion represents a small arachnoid cyst versus the etiology of doubtful clinical significance. He underwent a spinal tap under fluoroscopic guidance which revealed the following findings: fluid protein 80 mg/dl, glucose 68 and white blood count was 23 white cells per microliter, 100% of mononuclear. The patient had PCR for herpes simples virus which was negative. The patient's basic metabolic panel was normal and his white count was 10,800 with 68% neutrophils, 17% lymphocytes, 8.4% monocytes and 5% eosinophils. The patient was discharged to home on 08-MAR-2007. His mental status did not change and he still had the same symptomatology of some disorientation and loss of higher cortical function. The discharge diagnosis was viral meningitis of undetermined etiology possibly post vaccination with Zostavax. The patient's discharge medications included PROTONIX "quarter" mg QD, naprosyn 300 mg PO BID and MIDRIN one capsule PO q 6h for severe headaches. The plan was for the patient to follow-up as an outpatient. As of 30-MAR-2007 the patient was at home and "doing much better". A lot check has been requested. It was reported that CSF fluid was available for PCR testing and the patient was enrolled in the Varicella Zoster virus identification program to identify if VZV is present and if it is present to identify if it is associated with the wild-type (WT) VZV strain or with the manufacturer vaccine VZV strain. The patient's viral meningitis was considered to be immediately life-threatening. Additional information has been requested. 04/24/07-records received from facility for DOS 03/05-03/08/07-DC DX: viral meningitis of undetermined etiology possible post vaccination with Zostavax. 3/2/07-Two hours after receiving vaccine C/O pain in neck as well as some achiness, developed disorientation and erratic driving.
Age: 76.0
Sex: M
Vaccine: VARZOS
Symptoms: CSF test abnormal, CSF white blood cell count, Disorientation, Encephalitis viral, Eosinophil count
Clinical narrative: Information has been received from a physician concerning a 75 year old male with no known history who on 02-MAR-2007 was vaccinated SC in the left deltoid with a 0.65 ml first dose of Zostavax (lot # 652925/0621F). There was no concomitant medication or illness at the time of vaccination. Two hours after vaccination on 02-MAR-2007, the patient started developing pain in his neck as well as some achiness. He developed some disorientation and erratic driving over the weekend and was seen by the physician on 05-MAR-2007. The physician recommended work-up for possible Zostavax related meningoencephalitis or viral encephalitis. He was admitted to the hospital observation unit and under went neurological consultation. A MRA of the brain showed no acute infarct, no MRA evidence of encephalitis or meningitis. A 13 mm right medical posterior inferior cerebellar cystic lesion represents a small arachnoid cyst versus the etiology of doubtful clinical significance. He underwent a spinal tap under fluoroscopic guidance which revealed the following findings: fluid protein 80 mg/dl, glucose 68 and white blood count was 23 white cells per microliter, 100% of mononuclear. The patient had PCR for herpes simples virus which was negative. The patient's basic metabolic panel was normal and his white count was 10,800 with 68% neutrophils, 17% lymphocytes, 8.4% monocytes and 5% eosinophils. The patient was discharged to home on 08-MAR-2007. His mental status did not change and he still had the same symptomatology of some disorientation and loss of higher cortical function. The discharge diagnosis was viral meningitis of undetermined etiology possibly post vaccination with Zostavax. The patient's discharge medications included PROTONIX "quarter" mg QD, naprosyn 300 mg PO BID and MIDRIN one capsule PO q 6h for severe headaches. The plan was for the patient to follow-up as an outpatient. As of 30-MAR-2007 the patient was at home and "doing much better". A lot check has been requested. It was reported that CSF fluid was available for PCR testing and the patient was enrolled in the Varicella Zoster virus identification program to identify if VZV is present and if it is present to identify if it is associated with the wild-type (WT) VZV strain or with the manufacturer vaccine VZV strain. The patient's viral meningitis was considered to be immediately life-threatening. Additional information has been requested. 04/24/07-records received from facility for DOS 03/05-03/08/07-DC DX: viral meningitis of undetermined etiology possible post vaccination with Zostavax. 3/2/07-Two hours after receiving vaccine C/O pain in neck as well as some achiness, developed disorientation and erratic driving.
Age: 76.0
Sex: M
Vaccine: VARZOS
Symptoms: Headache, Herpes simplex serology negative, Impaired driving ability, Lumbar puncture, Meningitis viral
Clinical narrative: Information has been received from a physician concerning a 75 year old male with no known history who on 02-MAR-2007 was vaccinated SC in the left deltoid with a 0.65 ml first dose of Zostavax (lot # 652925/0621F). There was no concomitant medication or illness at the time of vaccination. Two hours after vaccination on 02-MAR-2007, the patient started developing pain in his neck as well as some achiness. He developed some disorientation and erratic driving over the weekend and was seen by the physician on 05-MAR-2007. The physician recommended work-up for possible Zostavax related meningoencephalitis or viral encephalitis. He was admitted to the hospital observation unit and under went neurological consultation. A MRA of the brain showed no acute infarct, no MRA evidence of encephalitis or meningitis. A 13 mm right medical posterior inferior cerebellar cystic lesion represents a small arachnoid cyst versus the etiology of doubtful clinical significance. He underwent a spinal tap under fluoroscopic guidance which revealed the following findings: fluid protein 80 mg/dl, glucose 68 and white blood count was 23 white cells per microliter, 100% of mononuclear. The patient had PCR for herpes simples virus which was negative. The patient's basic metabolic panel was normal and his white count was 10,800 with 68% neutrophils, 17% lymphocytes, 8.4% monocytes and 5% eosinophils. The patient was discharged to home on 08-MAR-2007. His mental status did not change and he still had the same symptomatology of some disorientation and loss of higher cortical function. The discharge diagnosis was viral meningitis of undetermined etiology possibly post vaccination with Zostavax. The patient's discharge medications included PROTONIX "quarter" mg QD, naprosyn 300 mg PO BID and MIDRIN one capsule PO q 6h for severe headaches. The plan was for the patient to follow-up as an outpatient. As of 30-MAR-2007 the patient was at home and "doing much better". A lot check has been requested. It was reported that CSF fluid was available for PCR testing and the patient was enrolled in the Varicella Zoster virus identification program to identify if VZV is present and if it is present to identify if it is associated with the wild-type (WT) VZV strain or with the manufacturer vaccine VZV strain. The patient's viral meningitis was considered to be immediately life-threatening. Additional information has been requested. 04/24/07-records received from facility for DOS 03/05-03/08/07-DC DX: viral meningitis of undetermined etiology possible post vaccination with Zostavax. 3/2/07-Two hours after receiving vaccine C/O pain in neck as well as some achiness, developed disorientation and erratic driving.
Age: 76.0
Sex: M
Vaccine: VARZOS
Symptoms: Metabolic function test normal, Neck pain, Nuclear magnetic resonance imaging brain normal, Pain, Viral test negative
Clinical narrative: Information has been received from a physician concerning a 75 year old male with no known history who on 02-MAR-2007 was vaccinated SC in the left deltoid with a 0.65 ml first dose of Zostavax (lot # 652925/0621F). There was no concomitant medication or illness at the time of vaccination. Two hours after vaccination on 02-MAR-2007, the patient started developing pain in his neck as well as some achiness. He developed some disorientation and erratic driving over the weekend and was seen by the physician on 05-MAR-2007. The physician recommended work-up for possible Zostavax related meningoencephalitis or viral encephalitis. He was admitted to the hospital observation unit and under went neurological consultation. A MRA of the brain showed no acute infarct, no MRA evidence of encephalitis or meningitis. A 13 mm right medical posterior inferior cerebellar cystic lesion represents a small arachnoid cyst versus the etiology of doubtful clinical significance. He underwent a spinal tap under fluoroscopic guidance which revealed the following findings: fluid protein 80 mg/dl, glucose 68 and white blood count was 23 white cells per microliter, 100% of mononuclear. The patient had PCR for herpes simples virus which was negative. The patient's basic metabolic panel was normal and his white count was 10,800 with 68% neutrophils, 17% lymphocytes, 8.4% monocytes and 5% eosinophils. The patient was discharged to home on 08-MAR-2007. His mental status did not change and he still had the same symptomatology of some disorientation and loss of higher cortical function. The discharge diagnosis was viral meningitis of undetermined etiology possibly post vaccination with Zostavax. The patient's discharge medications included PROTONIX "quarter" mg QD, naprosyn 300 mg PO BID and MIDRIN one capsule PO q 6h for severe headaches. The plan was for the patient to follow-up as an outpatient. As of 30-MAR-2007 the patient was at home and "doing much better". A lot check has been requested. It was reported that CSF fluid was available for PCR testing and the patient was enrolled in the Varicella Zoster virus identification program to identify if VZV is present and if it is present to identify if it is associated with the wild-type (WT) VZV strain or with the manufacturer vaccine VZV strain. The patient's viral meningitis was considered to be immediately life-threatening. Additional information has been requested. 04/24/07-records received from facility for DOS 03/05-03/08/07-DC DX: viral meningitis of undetermined etiology possible post vaccination with Zostavax. 3/2/07-Two hours after receiving vaccine C/O pain in neck as well as some achiness, developed disorientation and erratic driving.