chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 70.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site erythema, Injection site induration, Injection site pain, Injection site warmth
Clinical narrative: Information has been received from a registered nurse concerning a 70 year old female with reflux esophagitis, fibromyalgia and allergies to amoxicillin, BACTRIM, amitriptyline hydrochloride (MSD), RESTORIL, MOBIC, MACRODNTIN, and "caines" who on 03-APR-2008 was vaccinated SC in the left upper arm with a dose of zoster vaccine live (Oka/Merck). Concomitant therapy included aspirin, omeprazole (MSD), and CYMBALTA. On 04-APR-2008, the patient was examined in the office and was found to have developed a severe injection site reaction. He had a 7 cm by 7 cm area of erythema at the injection site of the left upper arm. Within the 7 cm area there was a 5 cm area of induration, warmth, and tenderness. The patient was prescribed BENADRYL, TYLENOL, and ice compresses. No diagnostic laboratory tests were performed. At the time of the report, the patient had not recovered. A product quality complaint was not involved. Additional information has been requested.
Sex: U
Vaccine: VARZOS
Symptoms: Injection site erythema, Injection site swelling
Clinical narrative: Information has been received from a physician concerning a patient (demographic unknown) who on a unspecified date was vaccinated via subcutaneous injection with a dose of zoster vaccine live (Oka/Merck). Subsequently, the patient experienced an injection site reaction after receiving zoster vaccine live (Oka/Merck). The patient experienced redness and swelling at the injection site. At the time of the report, the outcomes of the events were unknown. Additional information has been requested.
Age: 70.0
Sex: F
Vaccine: VARZOS
Symptoms: Herpes zoster
Clinical narrative: Information has been received from a 71-year-old female consumer with a history of breast cancer with radiation about 8 years ago and "previously in her 50's had developed the shingles and eventually had recovered" who in April 2007, was vaccinated with a "single dose series" of zoster vaccine live (Oka/Merck). Concomitant therapy included vitamins (unspecified) and "abalide." On 18-FEB-2008, the patient noticed that she started to have pain in her right shoulder. The consumer reported that later on that night she noticed she had developed the shingles again which were located on her right side on the upper body around her breast area and her upper back. The consumer reported that her shingles did not have any puss sores, but she had pain. She did see a physician who gave her medication to treat the shingles. There were no laboratory tests performed. The consumer reported that the shingles have faded, but she still can see some of the lesions, and that her pain that she had associated with the shingles first went away in the front and then around 02-Apr-2008, the pain on her back had gone away. No product quality complaint was involved. Additional information has been requested.
Age: 18.0
Sex: F
Vaccine: VARZOS
Symptoms: Wrong drug administered
Clinical narrative: Information has been received from a health professional concerning an 18 year old female who was vaccinated on an unspecified date with zoster vaccine live (Oka/Merck) (Lot # 57559/0462U) (Dose and route not specified). The patient was given ZOSTAVAX (Oka/Merck) instead of GARDASIL vaccine. The reporter noted that this was a case of product confusion because both of the products looked the same. It was reported that both vaccines were in the freezer and were the only medications in the freezer. It was reported that the medications were not next to each other but close and the colors "similar." The nurse picked up the wrong medication. There were no adverse reactions reported. Additional information has been requested.
Age: 67.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site erythema, Injection site induration, Injection site pain, Injection site rash, Injection site swelling
Clinical narrative: Information has been received from a pharmacist concerning a 67 year old female patient with no allergies and a history of being very thin, who on 20-MAY-2008 was vaccinated SC in the left arm with a 0.65 mL dose of zoster vaccine live (Oka/Merck) (Lot # 659323/0164X). On 22-MAY-2008, the patient developed a red, painful, hot and swollen rash at the injection site, which was hard and warm to the touch. No diagnostic laboratory tests were performed. At the time of this report, the injection site reaction persisted. No product quality complaint was reported. Additional information has been requested. This is in follow-up to report(s) previously submitted on 6/24/2008. In information received from the physician's office it was reported that the office was not contacted and the patient was not seen in that office. It was reported that the vaccine was administered at a pharmacy. Additional information has been requested.
Age: 67.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site warmth
Clinical narrative: Information has been received from a pharmacist concerning a 67 year old female patient with no allergies and a history of being very thin, who on 20-MAY-2008 was vaccinated SC in the left arm with a 0.65 mL dose of zoster vaccine live (Oka/Merck) (Lot # 659323/0164X). On 22-MAY-2008, the patient developed a red, painful, hot and swollen rash at the injection site, which was hard and warm to the touch. No diagnostic laboratory tests were performed. At the time of this report, the injection site reaction persisted. No product quality complaint was reported. Additional information has been requested. This is in follow-up to report(s) previously submitted on 6/24/2008. In information received from the physician's office it was reported that the office was not contacted and the patient was not seen in that office. It was reported that the vaccine was administered at a pharmacy. Additional information has been requested.
Age: 63.0
Sex: M
Vaccine: FLUX, VARZOS
Symptoms: Gait disturbance, Herpes zoster, Pain, Rash, Tenderness
Clinical narrative: Information has been received from a registered nurse concerning a 64-year-old male, with no pertinent medical history or allergies, who on 27-SEP-2007 was vaccinated subcutaneous with a "single dose" of zoster vaccine live (Oka/Merck) (lot # 658081/0743U). Concomitant vaccine included a dose of influenza virus vaccine (unspecified). On 31-MAR-2008 the patient developed shingles. The rash appeared on the patient's hip and buttocks and because of the pain and tenderness around the rash he has a hard time walking. The patient was seen by the physician. No diagnostic labs were performed. At the time of the report the patient's status was not recovered. A product quality complaint was not involved. Additional information has been requested.
Age: 67.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site erythema, Pharyngolaryngeal pain, Pyrexia, Rash pruritic, Varicella
Clinical narrative: Information has been received initially from a pharmacist concerning a 67 year old female who on 19-MAR-2008 was vaccinated with a dose of zoster vaccine live (Oka/Merck). On approximately 02-APR-2008 (about 2 weeks later) the patient experienced chickenpox rash on arms and trunk which the rash was itchy, a sore throat, fever and redness at the injection site. Follow-up information received from the nurse practitioner indicating that the patient had the rash for 3 or 4 days. The patient was recovering at the time of the report. In regards to the patient receiving medical attention, she consulted with the pharmacist. No product quality complaint. Additional information has been requested.
Sex: F
Vaccine: VARZOS
Symptoms: Injection site irritation, Injection site pruritus
Clinical narrative: Information has been received from a physician concerning a female who on 05-FEB-2008 was vaccinated with zoster vaccine live (Oka/Merck). "Ever since she was vaccinated", on 05-FEB-2008, the patient has experienced itchiness and a burning sensation at the injection site. It was noted that the patient's husband (WAES # 0802USA04107) was also vaccinated on 05-FEB-2008 with 0.65 ml of zoster vaccine live (Oka/Merck) and developed shingles ten days post vaccination. Additional information has been requested.
Age: 70.0
Sex: F
Vaccine: VARZOS
Clinical narrative: Information has been received from a female consumer with a history of severe painful shingles outbreaks who in October 2007, was vaccinated with zoster vaccine live (Oka/Merck). The patient believes the vaccination treated her shingles outbreaks and the pain associated with the outbreaks. At the time of the report the patient's status was unknown. There was no product quality complaint involved. No further information is available. This is in follow-up to report(s) previously submitted on 6/24/2008.  Follow-up information was received from the consumer.  The patient recently developed two painful lesion on her left shoulder.  No other symptoms were noted.  The patient's two painful lesion on her left shoulder persisted.  The patient did not seek any medical attention.  Follow-up information from a registered nurse indicated that they had no record of an adverse reaction for this patient.  Additional information is not expected.
Age: 65.0
Sex: F
Vaccine: VARZOS
Symptoms: Tooth fracture
Clinical narrative: Information has been received from a pharmacist concerning a 65 year old female consumer with codeine and sulfonamide allergies and no pertinent medical history who on 02-APR-2008 was vaccinated SQ with zoster vaccine live (Oka/Merck) (lot # 659762/1874U). Concomitant therapy included RELAFEN, LUMIGAN and LEVOXYL. On 02-APR-2008, the patient broke her tooth after receiving the vaccine. Medical attention was sought via the telephone. There were no lab studies performed. At the time of the report the patient was recovering. There was no product complaint involved. Additional information has been requested.
Age: 60.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site erythema, Injection site induration, Injection site irritation, Injection site pain
Clinical narrative: Information has been received from a physician concerning a 60 year old female consumer with sulfonamide allergy who on 02-APR-2008 was vaccinated SQ with 0.65mL zoster vaccine live (Oka/Merck) (lot # 659404/1826U). Concomitant therapy included PREVACID, SYNTHROID, EFFEXOR XR, ezetimibe (MSD), ACTONEL, aspirin and simvastatin. Several hours post vaccination on 02-APR-2008 the patient experienced an injection site reaction that included, induration, redness, burning and stinging. No other symptoms were noted. Unspecified medical attention was sought. There were no lab studies performed. At the time of the report the patient was recovering. There was no product quality complaint involved. Additional information has been requested.
Age: 87.0
Sex: F
Vaccine: VARZOS
Symptoms: Herpes zoster
Clinical narrative: Information has been received from an office manager concerning an 87 year old female consumer with degenerative joint disease, hypertension and drug allergies to ACTONEL, alendroanate sodium, MIACALCIN and glucosamine who on 07-FEB-2008 was vaccinated with a single series of zoster vaccine live (Oka/Merck) (lot # 659326/1824U). Concomitant therapy included "some different medications." The office manager reported the patient received the vaccination and then three weeks later on approximately 28-FEB-2008 the patient broke out in a mild case of shingles, which were not painful. The patient had red spots that were located on her back and "flack" area. It was noted that the patient did not tell the physician until she came in for her routine check up on 03-APR-2008. There were no lab studies performed. At the time of the report the patient still had some spots on her body, but she was recovering. There was no product quality complaint involved, Additional information has been requested. The patient also had an adverse experience after being placed on therapy with alendroanate sodium (WAES # 0804USA02780).
Age: 67.0
Sex: F
Vaccine: VARZOS
Symptoms: Asthenia, Condition aggravated
Clinical narrative: This is in follow-up to report(s) previously submitted on 6/24/2008. Information has been received from a physician concerning a female with multiple sclerosis (MS) and is wheelchair bound who on the morning of 29-AUG-2007 was vaccinated with zoster vaccine live (Oka/Merck) subcutaneously (lot#: 658085/0882U). Subsequently, the patient experienced excessive weakness; even more weakness than she usually felt with her multiple sclerosis. She was sliding out of her chair. Subsequently, the patient recovered. Additional information is not expected.
Age: 82.0
Sex: M
Vaccine: VARZOS
Symptoms: Herpes zoster
Clinical narrative: Information has been received from a consumer concerning her 82 year old husband with no known allergies, diabetes, hypertension, osteoporosis and depression and a history of cerebrovascular accident who on 13-JUN-2007 was vaccinated SQ with a first dose series of 0.65 mL of zoster vaccine live (Oka/Merck). Concomitant therapy included lisinopril, diltiazem HCl, simvastatin, terazosin, hydrochloride, alendronate sodium (MSD), NOVOLIN, NOVOLOG and citalopram hydrobromide. On 27-MAR-2008, the patient developed shingles. The patient's shingles have improved, but he has not completely recovered. She also stated she had concerns as to how the vaccine was stored at the pharmacy where her husband received the vaccine. However, her specific storage concerns were not reported. Unspecified medical attention was sought. There were no lab studies performed. There was no product quality complaint involved. Additional information has been requested.
Sex: U
Vaccine: VARZOS
Symptoms: Rash
Clinical narrative: Information has been received from a registered nurse concerning a patient who on an unspecified date was vaccinated with zoster vaccine live (Oka/Merck). Subsequently, the patient developed an undiagnosed rash. At the time of the report the patient's status was unknown. Additional information has been requested. This is one of several reports from the same source.
Sex: U
Vaccine: VARZOS
Symptoms: Herpes zoster
Clinical narrative: Information has been received from a registered nurse concerning a patient who on an unspecified date was vaccinated with zoster vaccine live (Oka/Merck). Subsequently, the patient developed shingles. At the time of the report the patient's status was unknown. Additional information has been requested. This is one of several reports from the same source.
Age: 73.0
Sex: F
Vaccine: VARZOS
Symptoms: Angina pectoris
Clinical narrative: Information has been received from a pharmacist concerning a 73 year old female with a history of hypertension who on 31-MAR-2008 was vaccinated with a dose of zoster vaccine live (Oka/Merck). On 04-APR-2008, the patient experienced angina. It was unknown if the angina resolved. Additional information has been requested.
Age: 2.0
Sex: M
Vaccine: HIBV, MMR, PPV
Symptoms: Abasia, Arthralgia
Clinical narrative: My son can not walk, he is complaining about righ knee pain after yesterdays vaccination. I'm going to see a doctor and check with him.
Age: 9.0
Sex: F
Vaccine: VARCEL
Symptoms: Erythema, Oedema peripheral
Clinical narrative: Received chicken pox vaccine on 7-90-08. Started with redness the same day, afebrile with swelling to the arm. In office, area of redness measured 3.5cm x 4cm. Symptomatic treatment advised.
Age: 18.0
Sex: F
Vaccine: HPV4
Symptoms: Injection site pain, Injection site swelling
Clinical narrative: The patient developed severe pain in her right arm where the second Garadsil vaccine was placed. I saw her 1 week after the vaccine was administered, and the site of the vaccine was swollen and the pt had excruciating pain.
Age: 72.0
Sex: F
Vaccine: UNK
Symptoms: Erythema, Insomnia, Mobility decreased, Oedema peripheral, Pain in extremity
Clinical narrative: Vaccine was given in the left under arm in the fatty tissue on tuesdat at @11:15am. 5 hours later the arm began to swell, turn red & hot and very painful.  Continued to get worse and was unable to sleep well that night[Tuesday]. Next day[Wednesday] swelling covered larger area, still hot & red.  The pain was so sever that I was unable to move my arm at all.  Called the doctor.  Never returned my call until the next day [Thursday]. I was told to take ibuprofen and apply ice.  Friday, arm still swollen, hot and red, only not as bad and pain less sever. Saturday,no reddness, slight swelling, no pain, but tender to the touch.  In hind-sight I should have went to the emergency.
Age: 72.0
Sex: F
Vaccine: UNK
Symptoms: Skin warm, Tenderness
Clinical narrative: Vaccine was given in the left under arm in the fatty tissue on tuesdat at @11:15am. 5 hours later the arm began to swell, turn red & hot and very painful.  Continued to get worse and was unable to sleep well that night[Tuesday]. Next day[Wednesday] swelling covered larger area, still hot & red.  The pain was so sever that I was unable to move my arm at all.  Called the doctor.  Never returned my call until the next day [Thursday]. I was told to take ibuprofen and apply ice.  Friday, arm still swollen, hot and red, only not as bad and pain less sever. Saturday,no reddness, slight swelling, no pain, but tender to the touch.  In hind-sight I should have went to the emergency.
Age: 4.0
Sex: F
Vaccine: DTAP, IPV
Symptoms: Injection site induration, Injection site oedema
Clinical narrative: left upper arm edema from detoid to elbow, was hard per parent, soft and pliable to my exam, without pain, without redness
Age: 58.0
Sex: F
Vaccine: HBPV
Symptoms: Urticaria
Clinical narrative: VERY BAD HIVES.I TOOK A BENADRLY
Age: 22.0
Sex: M
Vaccine: ANTH
Symptoms: Chills, Headache, Lumbar puncture normal, Musculoskeletal stiffness, Nausea
Clinical narrative: HEADACHE, NECK STIFFNESS, FEVER/CHILLS, NAUSEA, 24 HOURS POST VACCINATION. REFRRED TO NEUROLOGY.
Age: 22.0
Sex: M
Vaccine: ANTH
Symptoms: Pyrexia
Clinical narrative: HEADACHE, NECK STIFFNESS, FEVER/CHILLS, NAUSEA, 24 HOURS POST VACCINATION. REFRRED TO NEUROLOGY.
Age: 84.0
Sex: F
Vaccine: VARZOS, VARZOS
Symptoms: Lethargy, Oxygen saturation decreased, Tachycardia, Tremor
Clinical narrative: immediate reaction . . . hypertension, tachycardia, tremors, protration, nausea . . . all lasted two hours and recurred at brief intervals .. . several times on following day, lasting 15 minutes to hours.
Age: 84.0
Sex: F
Vaccine: VARZOS, VARZOS
Symptoms: Fatigue, Hypertension, Immediate post-injection reaction, Nausea, Tachycardia
Clinical narrative: immediate reaction . . . hypertension, tachycardia, tremors, protration, nausea . . . all lasted two hours and recurred at brief intervals .. . several times on following day, lasting 15 minutes to hours.
Age: 84.0
Sex: F
Vaccine: VARZOS, VARZOS
Symptoms: Tremor
Clinical narrative: immediate reaction . . . hypertension, tachycardia, tremors, protration, nausea . . . all lasted two hours and recurred at brief intervals .. . several times on following day, lasting 15 minutes to hours.
Age: 13.0
Sex: F
Vaccine: HPV4
Symptoms: Activities of daily living impaired, Arthralgia, Back pain, Bedridden, Dysmenorrhoea
Clinical narrative: 7/13/08    Re: 13yr healthy, 5'5" 106lb active, phsically fit, golfs, swims. Gardasil administered Thur, July 3.  Extreme pain at injection site and significant pain & discomfort for several days following.  Pain was at injection site, elbow up, upper arm, shoulder neck & upper back. My daughter began menstruating May.  Her period May was  light and June was normal.  This month however began July 11, the week leading up to menstruating she suffered incredible cramping.  With the onset of her period, she became bedridden and suffered horribly.  Call to triage nurse gave all helpful tips but I went through them with my daughter with very little relief. ie. Midol, we had reduced pain with Pamprin but still the level of pain was dibilitating and kept her in bed 2 days, rolling around in pain.  Pamprin has 500mg per pill. She took 2 every 4 hours just to keep the level bareable. Even with this level of pain medicine she was not able to resume normal activity.  This level of medicine is too much for a 13 yr old! other suggestions laying flat rather than crunched in fetal position that she had been, warm pad, deep breath to work through pain, TV to take mind off agony, massage, comfort foods - tried them with little relief.  The women on my side of family have no history of cramps or the severe reaction to normal healthy menstrual cycle as well as the females on my husband's side of family.  Menstrual flow is normal, nothing excessive to indicate another reason for such severe pain.  I feel the Gardasil vaccination is responsible for this unusual extreme pain.  She was too ill to drive to dr office but I will be calling them again Monday morning 7/14/08.
Age: 13.0
Sex: F
Vaccine: HPV4
Symptoms: Injection site discomfort, Injection site pain, Menstruation irregular, Neck pain, Pain in extremity
Clinical narrative: 7/13/08    Re: 13yr healthy, 5'5" 106lb active, phsically fit, golfs, swims. Gardasil administered Thur, July 3.  Extreme pain at injection site and significant pain & discomfort for several days following.  Pain was at injection site, elbow up, upper arm, shoulder neck & upper back. My daughter began menstruating May.  Her period May was  light and June was normal.  This month however began July 11, the week leading up to menstruating she suffered incredible cramping.  With the onset of her period, she became bedridden and suffered horribly.  Call to triage nurse gave all helpful tips but I went through them with my daughter with very little relief. ie. Midol, we had reduced pain with Pamprin but still the level of pain was dibilitating and kept her in bed 2 days, rolling around in pain.  Pamprin has 500mg per pill. She took 2 every 4 hours just to keep the level bareable. Even with this level of pain medicine she was not able to resume normal activity.  This level of medicine is too much for a 13 yr old! other suggestions laying flat rather than crunched in fetal position that she had been, warm pad, deep breath to work through pain, TV to take mind off agony, massage, comfort foods - tried them with little relief.  The women on my side of family have no history of cramps or the severe reaction to normal healthy menstrual cycle as well as the females on my husband's side of family.  Menstrual flow is normal, nothing excessive to indicate another reason for such severe pain.  I feel the Gardasil vaccination is responsible for this unusual extreme pain.  She was too ill to drive to dr office but I will be calling them again Monday morning 7/14/08.
Age: 38.0
Sex: M
Vaccine: SMALL
Symptoms: Blister, Rash
Clinical narrative: 2 WEEKS POST ADMINISTRATION OF SMALL POX IMMUNIZATION, PT DELEVOPED BLISTERING RASH ON HANDS, ELBOWS, INSIDE ARMS, ANKLES, AND TORSO.
Age: 62.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site erythema, Injection site swelling
Clinical narrative: Patient had a reddened swollen arm at the vaccine administration site.
Age: 18.0
Sex: F
Vaccine: MEN
Symptoms: Headache, Injected limb mobility decreased, Injection site pain, Pyrexia
Clinical narrative: Fever and headache on date administered. Intense lingering injection site pain. Limited range of motion due to pain and stiffness in the appendage where vaccination was given.  Pain and stiffness continues a week after injection was given.
Sex: U
Vaccine: PPV
Symptoms: Injection site urticaria, Urticaria
Clinical narrative: After receiving the Prevnar and 4 days prior received Rotavirus, the patient developed an urticarial looking rash at the lateral aspect of the leg where he received the vaccine. He also developed the same urticarial rash at the rest of the lateral aspect of the leg and no other places in the body. The rash did not resolved with Benadryl. He has no fever and the rash however does no seem to be pruritic. i have never seen a reaction that is not cellulitis  only on one leg if it is allergic. Could you tell me if this is expected with Prevnar?
Age: 46.0
Sex: F
Vaccine: TYP, TYP
Symptoms: Headache, Nausea, Rash, Swelling, Vomiting
Clinical narrative: Patient received typhoid vaccine at 11:30. Patient began to have severe headache, nausea, vomiting, swelling and rash. Patient was brought to Emergency Department to be treated.
Age: 46.0
Sex: F
Vaccine: TYP, TYP
Symptoms: Blood pressure increased, Headache, Nausea, Swelling face, Vomiting
Clinical narrative: Patient received typhoid vaccine at 11:30. Patient began to have severe headache, nausea, vomiting, swelling and rash. Patient was brought to Emergency Department to be treated.
Age: 80.0
Sex: M
Vaccine: VARZOS, VARZOS, VARZOS
Symptoms: Blood product transfusion, CSF protein increased, Electromyogram abnormal, Guillain-Barre syndrome, Headache
Clinical narrative: Patient received ZOSTAVAX vaccine 4/29/08, one day later noticed trouble getting into his truck and lifting things. His neurological presentation was on of acute onset of bilateral global upper and lower extremity weakness (UE>LE); IVIG was given x 5d along with acyclovir with significant improvement
Age: 80.0
Sex: M
Vaccine: VARZOS, VARZOS, VARZOS
Symptoms: Immunoglobulins, Muscular weakness, Polymerase chain reaction, Red blood cells CSF positive, Viral DNA test negative
Clinical narrative: Patient received ZOSTAVAX vaccine 4/29/08, one day later noticed trouble getting into his truck and lifting things. His neurological presentation was on of acute onset of bilateral global upper and lower extremity weakness (UE>LE); IVIG was given x 5d along with acyclovir with significant improvement
Age: 80.0
Sex: M
Vaccine: VARZOS, VARZOS, VARZOS
Symptoms: Body temperature increased, CSF cell count, CSF glucose, CSF test abnormal, CSF white blood cell count
Clinical narrative: Patient received ZOSTAVAX vaccine 4/29/08, one day later noticed trouble getting into his truck and lifting things. His neurological presentation was on of acute onset of bilateral global upper and lower extremity weakness (UE>LE); IVIG was given x 5d along with acyclovir with significant improvement
Age: 80.0
Sex: M
Vaccine: VARZOS, VARZOS, VARZOS
Symptoms: Muscular weakness
Clinical narrative: Patient received ZOSTAVAX vaccine 4/29/08, one day later noticed trouble getting into his truck and lifting things. His neurological presentation was on of acute onset of bilateral global upper and lower extremity weakness (UE>LE); IVIG was given x 5d along with acyclovir with significant improvement
Age: 80.0
Sex: M
Vaccine: VARZOS, VARZOS, VARZOS
Symptoms: Activities of daily living impaired, CSF oligoclonal band absent, CSF protein increased, Electromyogram abnormal, Mobility decreased
Clinical narrative: Patient received ZOSTAVAX vaccine 4/29/08, one day later noticed trouble getting into his truck and lifting things. His neurological presentation was on of acute onset of bilateral global upper and lower extremity weakness (UE>LE); IVIG was given x 5d along with acyclovir with significant improvement
Age: 80.0
Sex: M
Vaccine: VARZOS, VARZOS, VARZOS
Symptoms: Muscular weakness, Polymerase chain reaction, Viral DNA test negative
Clinical narrative: Patient received ZOSTAVAX vaccine 4/29/08, one day later noticed trouble getting into his truck and lifting things. His neurological presentation was on of acute onset of bilateral global upper and lower extremity weakness (UE>LE); IVIG was given x 5d along with acyclovir with significant improvement
Age: 0.4
Sex: U
Vaccine: DTAPHEPBIP, HIBV, PNC, RV5, DTAPHEPBIP, HIBV, PNC, RV5, DTAPHEPBIP, HIBV, PNC, RV5, DTAPHEPBIP, HIBV, PNC, RV5, DTAPHEPBIP, HIBV, PNC, RV5
Symptoms: Unresponsive to stimuli
Clinical narrative: Initial report received on 03 July 2008 from a health care professional.  A four-month-old patient had received a first dose of ACTHIB (Lot # UF366AA, Sanofi Pasteur SA Lot # A0802-2); a first dose of PEDIARIX (manufacturer GlaxoSmithKline, Lot # AC21D143AA); a first dose of PREVNAR (Manufacturer Wyeth, Lot # C65930); and a first dose of ROTATEQ (manufacturer Merck, Lot # 501X) on 01 July 2008.  On 01 July 2008 at approximately 10:00 p.m., the patient had "CTB" (ceased to breathe) and had died.  The patient was found dead by the parent.  An autopsy is to be completed; however the date was not provided.
Age: 0.4
Sex: U
Vaccine: DTAPHEPBIP, HIBV, PNC, RV5, DTAPHEPBIP, HIBV, PNC, RV5, DTAPHEPBIP, HIBV, PNC, RV5, DTAPHEPBIP, HIBV, PNC, RV5, DTAPHEPBIP, HIBV, PNC, RV5
Symptoms: Death
Clinical narrative: Initial report received on 03 July 2008 from a health care professional.  A four-month-old patient had received a first dose of ACTHIB (Lot # UF366AA, Sanofi Pasteur SA Lot # A0802-2); a first dose of PEDIARIX (manufacturer GlaxoSmithKline, Lot # AC21D143AA); a first dose of PREVNAR (Manufacturer Wyeth, Lot # C65930); and a first dose of ROTATEQ (manufacturer Merck, Lot # 501X) on 01 July 2008.  On 01 July 2008 at approximately 10:00 p.m., the patient had "CTB" (ceased to breathe) and had died.  The patient was found dead by the parent.  An autopsy is to be completed; however the date was not provided.
Age: 0.4
Sex: U
Vaccine: DTAPHEPBIP, HIBV, PNC, RV5, DTAPHEPBIP, HIBV, PNC, RV5, DTAPHEPBIP, HIBV, PNC, RV5, DTAPHEPBIP, HIBV, PNC, RV5, DTAPHEPBIP, HIBV, PNC, RV5
Symptoms: Death, Respiratory arrest
Clinical narrative: Initial report received on 03 July 2008 from a health care professional.  A four-month-old patient had received a first dose of ACTHIB (Lot # UF366AA, Sanofi Pasteur SA Lot # A0802-2); a first dose of PEDIARIX (manufacturer GlaxoSmithKline, Lot # AC21D143AA); a first dose of PREVNAR (Manufacturer Wyeth, Lot # C65930); and a first dose of ROTATEQ (manufacturer Merck, Lot # 501X) on 01 July 2008.  On 01 July 2008 at approximately 10:00 p.m., the patient had "CTB" (ceased to breathe) and had died.  The patient was found dead by the parent.  An autopsy is to be completed; however the date was not provided.
Age: 16.0
Sex: F
Vaccine: VARCEL
Symptoms: Erythema, Induration, Oedema peripheral, Skin warm
Clinical narrative: Information has been received from a registered nurse (R.N.) concerning a 16 year old female student with dyslexia, alexia and depression who on 09-JUN-2008 was vaccinated subcutaneously in the left arm with a second dose of VARIVAX (Oka/Merck) (Lot #659357/1567U).  There was no illness at the time of vaccination.  Concomitant therapy included fluoxetine.  On 10-JUN-2008, at 8:00 p.m., the patient developed left upper arm erythema, induration, warmth and edema.  The outcome of the patient was unknown.  Unspecified medical attention was sought.  The reporter considered left upper arm erythema, induration, warmth and edema to be other important medical events.  This is one of several reports from the same source.  Additional information is not expected.
Age: 16.0
Sex: F
Vaccine: HPV4
Symptoms: Abdominal pain, Caesarean section, Depression, Drug exposure during pregnancy, Genital haemorrhage
Clinical narrative: Initial and follow-up information has been received from a registered nurse for the Pregnancy Registry for GARDASIL concerning a 16 year old female with asthma who on 24-SEP-2007 was vaccinated IM with a 0.5 ml first dose of GARDASIL (lot #654535/0960F).  On approximately 12-NOV-2007, the patient developed depression and was placed on tapering dose of PROZAC.  On 05-DEC-2007, the patient was vaccinated IM with a 0.5 ml second dose of GARDASIL (lot #654535/0960F).  Subsequently the patient became pregnant.  Unspecified medical attention was sought.  Last menstrual period was approximately 25-AUG-2007 and estimated date of delivery was 31-MAY-2007.  On approximately 10-DEC-2007, the patient developed nausea and was placed on therapy with PHENERGAN.  On 03-JAN-2008, the patient had vaginal spotting.  Abdominal ultrasound was within normal limits.  On 14-JAN-2008, the patient pelvic pain.  An gallbladder ultrasound on 14-JAN-2008 (also reported as 15-JAN-2008) was within normal limits.  On an unspecified date, the patient developed abdominal pain.  The patient had an ultrasound on 31-MAR-2008 (results not reported).  On 23-MAY-2008, the patient had a cesarean section due to cephalopelvic disproportion.  The patient gave birth to a normal male infant (weight 6 pounds, 11 ounces) that was given for adoption.  Upon internal review, cephalo-pelvic disproportion leading to a cesarean section was considered to be an other important medical event.  Additional information has been requested.
Age: 16.0
Sex: F
Vaccine: HPV4
Symptoms: Nausea, Pelvic pain, Ultrasound scan normal
Clinical narrative: Initial and follow-up information has been received from a registered nurse for the Pregnancy Registry for GARDASIL concerning a 16 year old female with asthma who on 24-SEP-2007 was vaccinated IM with a 0.5 ml first dose of GARDASIL (lot #654535/0960F).  On approximately 12-NOV-2007, the patient developed depression and was placed on tapering dose of PROZAC.  On 05-DEC-2007, the patient was vaccinated IM with a 0.5 ml second dose of GARDASIL (lot #654535/0960F).  Subsequently the patient became pregnant.  Unspecified medical attention was sought.  Last menstrual period was approximately 25-AUG-2007 and estimated date of delivery was 31-MAY-2007.  On approximately 10-DEC-2007, the patient developed nausea and was placed on therapy with PHENERGAN.  On 03-JAN-2008, the patient had vaginal spotting.  Abdominal ultrasound was within normal limits.  On 14-JAN-2008, the patient pelvic pain.  An gallbladder ultrasound on 14-JAN-2008 (also reported as 15-JAN-2008) was within normal limits.  On an unspecified date, the patient developed abdominal pain.  The patient had an ultrasound on 31-MAR-2008 (results not reported).  On 23-MAY-2008, the patient had a cesarean section due to cephalopelvic disproportion.  The patient gave birth to a normal male infant (weight 6 pounds, 11 ounces) that was given for adoption.  Upon internal review, cephalo-pelvic disproportion leading to a cesarean section was considered to be an other important medical event.  Additional information has been requested.
Age: 13.0
Sex: F
Vaccine: HPV4, VARCEL
Symptoms: Abdominal pain upper, Blood test normal, Computerised tomogram normal, Convulsion, Dermatitis
Clinical narrative: Information has been received from a nurse concerning her previously healthy, menstruating 13 year old daughter with a sibling with seizure disorder who on 19-JUN-2008 was vaccinated with a first dose of GARDASIL. Concomitant suspect vaccination on 19-JUN-2008 included a second dose of VARIVAX. Other suspect therapy included BENADRYL (dose, duration and indication not reported) and BACTRIM given on 23-JUN-2008 and 24-JUN-2008 of the treatment of urinary tract infection (dose not reported). On 20-JUN-2008 the patient experienced severe headache and right arm swelling. On 22-JUN-2008 at 9:30 AM, the patient experienced a seizure for one hour, fell and experienced a "huge abrasion under the chin." The patient began to seizure again at 3:00 PM and was admitted to the intensive care unit. The reporter stated that the seizures started with a headache and then the patient had a blank stare. She had severe right hand spasms and moved her head back and forth. She had involuntary muscle movements with rhythmic movements, mostly of the upper extremity, and jerky, spastic contractions in the lower extremities with plantar flexion of the right foot and a jerky knee. She had dilated pupils and "foaming at the mouth." Sometimes she had wheezing. Sometimes was responsive and sometimes not. Seizure duration was reported as long as 45 minutes and "for hours." On approximately 22-JUN-2008 diagnostic work-up included an electroencephalogram (EEG) which was negative and a magnetic resonance imaging (MRI) and computerized axial tomography (CT) which were normal. "Blood work" and urinalysis were normal. On approximately 23-JUN-2008 the patient had a urinary tract infection that was treated with BACTRIM on 23-JUN-2008 and 24-JUN-2008. The patient was diagnosed with pseudoseizure. On 24-JUN-2008 the patient experienced a 10 minute seizure and was discharged. she was hospitalized for 2.5 days. On approximately 29-JUN-2008, the patient experienced hives and dermatitis which may have been due to an allergy to BACTRIM and was hospitalized. The patient was treated with BENADRYL and experienced seizures several hours after the dose was administered. The patient was discharged in the morning on 01-JUL-2008. She was hospitalized for 2.5 days (also reported as 1.5 days). On 01-JUL-2008 at 5:15 pm, the patient had a headache for 10 minutes, epigastric pain, wheezing and a seizure with unconsciousness. She was transported by emergency medical services to the emergency room. She was treated with ATIVAN. The outcomes of the epigastric pain, pseudoseizures, dermatitis, fell/huge abrasion under chin, severe headache, right arm swelling, urinary tract infection, hives and wheezing were unknown. The reporter thought her daughter's seizures were related to GARDASIL. The reporter did not think her daughter's seizures, hives and dermatitis were due to psychological problems. Additional information has been requested.
Age: 13.0
Sex: F
Vaccine: HPV4, VARCEL
Symptoms: Drug hypersensitivity, Dyskinesia, Electroencephalogram normal, Excoriation, Fall
Clinical narrative: Information has been received from a nurse concerning her previously healthy, menstruating 13 year old daughter with a sibling with seizure disorder who on 19-JUN-2008 was vaccinated with a first dose of GARDASIL. Concomitant suspect vaccination on 19-JUN-2008 included a second dose of VARIVAX. Other suspect therapy included BENADRYL (dose, duration and indication not reported) and BACTRIM given on 23-JUN-2008 and 24-JUN-2008 of the treatment of urinary tract infection (dose not reported). On 20-JUN-2008 the patient experienced severe headache and right arm swelling. On 22-JUN-2008 at 9:30 AM, the patient experienced a seizure for one hour, fell and experienced a "huge abrasion under the chin." The patient began to seizure again at 3:00 PM and was admitted to the intensive care unit. The reporter stated that the seizures started with a headache and then the patient had a blank stare. She had severe right hand spasms and moved her head back and forth. She had involuntary muscle movements with rhythmic movements, mostly of the upper extremity, and jerky, spastic contractions in the lower extremities with plantar flexion of the right foot and a jerky knee. She had dilated pupils and "foaming at the mouth." Sometimes she had wheezing. Sometimes was responsive and sometimes not. Seizure duration was reported as long as 45 minutes and "for hours." On approximately 22-JUN-2008 diagnostic work-up included an electroencephalogram (EEG) which was negative and a magnetic resonance imaging (MRI) and computerized axial tomography (CT) which were normal. "Blood work" and urinalysis were normal. On approximately 23-JUN-2008 the patient had a urinary tract infection that was treated with BACTRIM on 23-JUN-2008 and 24-JUN-2008. The patient was diagnosed with pseudoseizure. On 24-JUN-2008 the patient experienced a 10 minute seizure and was discharged. she was hospitalized for 2.5 days. On approximately 29-JUN-2008, the patient experienced hives and dermatitis which may have been due to an allergy to BACTRIM and was hospitalized. The patient was treated with BENADRYL and experienced seizures several hours after the dose was administered. The patient was discharged in the morning on 01-JUL-2008. She was hospitalized for 2.5 days (also reported as 1.5 days). On 01-JUL-2008 at 5:15 pm, the patient had a headache for 10 minutes, epigastric pain, wheezing and a seizure with unconsciousness. She was transported by emergency medical services to the emergency room. She was treated with ATIVAN. The outcomes of the epigastric pain, pseudoseizures, dermatitis, fell/huge abrasion under chin, severe headache, right arm swelling, urinary tract infection, hives and wheezing were unknown. The reporter thought her daughter's seizures were related to GARDASIL. The reporter did not think her daughter's seizures, hives and dermatitis were due to psychological problems. Additional information has been requested.
Age: 13.0
Sex: F
Vaccine: HPV4, VARCEL
Symptoms: Foaming at mouth, Headache, Loss of consciousness, Muscle spasms, Mydriasis
Clinical narrative: Information has been received from a nurse concerning her previously healthy, menstruating 13 year old daughter with a sibling with seizure disorder who on 19-JUN-2008 was vaccinated with a first dose of GARDASIL. Concomitant suspect vaccination on 19-JUN-2008 included a second dose of VARIVAX. Other suspect therapy included BENADRYL (dose, duration and indication not reported) and BACTRIM given on 23-JUN-2008 and 24-JUN-2008 of the treatment of urinary tract infection (dose not reported). On 20-JUN-2008 the patient experienced severe headache and right arm swelling. On 22-JUN-2008 at 9:30 AM, the patient experienced a seizure for one hour, fell and experienced a "huge abrasion under the chin." The patient began to seizure again at 3:00 PM and was admitted to the intensive care unit. The reporter stated that the seizures started with a headache and then the patient had a blank stare. She had severe right hand spasms and moved her head back and forth. She had involuntary muscle movements with rhythmic movements, mostly of the upper extremity, and jerky, spastic contractions in the lower extremities with plantar flexion of the right foot and a jerky knee. She had dilated pupils and "foaming at the mouth." Sometimes she had wheezing. Sometimes was responsive and sometimes not. Seizure duration was reported as long as 45 minutes and "for hours." On approximately 22-JUN-2008 diagnostic work-up included an electroencephalogram (EEG) which was negative and a magnetic resonance imaging (MRI) and computerized axial tomography (CT) which were normal. "Blood work" and urinalysis were normal. On approximately 23-JUN-2008 the patient had a urinary tract infection that was treated with BACTRIM on 23-JUN-2008 and 24-JUN-2008. The patient was diagnosed with pseudoseizure. On 24-JUN-2008 the patient experienced a 10 minute seizure and was discharged. she was hospitalized for 2.5 days. On approximately 29-JUN-2008, the patient experienced hives and dermatitis which may have been due to an allergy to BACTRIM and was hospitalized. The patient was treated with BENADRYL and experienced seizures several hours after the dose was administered. The patient was discharged in the morning on 01-JUL-2008. She was hospitalized for 2.5 days (also reported as 1.5 days). On 01-JUL-2008 at 5:15 pm, the patient had a headache for 10 minutes, epigastric pain, wheezing and a seizure with unconsciousness. She was transported by emergency medical services to the emergency room. She was treated with ATIVAN. The outcomes of the epigastric pain, pseudoseizures, dermatitis, fell/huge abrasion under chin, severe headache, right arm swelling, urinary tract infection, hives and wheezing were unknown. The reporter thought her daughter's seizures were related to GARDASIL. The reporter did not think her daughter's seizures, hives and dermatitis were due to psychological problems. Additional information has been requested.
Age: 13.0
Sex: F
Vaccine: HPV4, VARCEL
Symptoms: Nuclear magnetic resonance imaging normal, Staring, Urinary tract infection, Urine analysis normal, Urticaria
Clinical narrative: Information has been received from a nurse concerning her previously healthy, menstruating 13 year old daughter with a sibling with seizure disorder who on 19-JUN-2008 was vaccinated with a first dose of GARDASIL. Concomitant suspect vaccination on 19-JUN-2008 included a second dose of VARIVAX. Other suspect therapy included BENADRYL (dose, duration and indication not reported) and BACTRIM given on 23-JUN-2008 and 24-JUN-2008 of the treatment of urinary tract infection (dose not reported). On 20-JUN-2008 the patient experienced severe headache and right arm swelling. On 22-JUN-2008 at 9:30 AM, the patient experienced a seizure for one hour, fell and experienced a "huge abrasion under the chin." The patient began to seizure again at 3:00 PM and was admitted to the intensive care unit. The reporter stated that the seizures started with a headache and then the patient had a blank stare. She had severe right hand spasms and moved her head back and forth. She had involuntary muscle movements with rhythmic movements, mostly of the upper extremity, and jerky, spastic contractions in the lower extremities with plantar flexion of the right foot and a jerky knee. She had dilated pupils and "foaming at the mouth." Sometimes she had wheezing. Sometimes was responsive and sometimes not. Seizure duration was reported as long as 45 minutes and "for hours." On approximately 22-JUN-2008 diagnostic work-up included an electroencephalogram (EEG) which was negative and a magnetic resonance imaging (MRI) and computerized axial tomography (CT) which were normal. "Blood work" and urinalysis were normal. On approximately 23-JUN-2008 the patient had a urinary tract infection that was treated with BACTRIM on 23-JUN-2008 and 24-JUN-2008. The patient was diagnosed with pseudoseizure. On 24-JUN-2008 the patient experienced a 10 minute seizure and was discharged. she was hospitalized for 2.5 days. On approximately 29-JUN-2008, the patient experienced hives and dermatitis which may have been due to an allergy to BACTRIM and was hospitalized. The patient was treated with BENADRYL and experienced seizures several hours after the dose was administered. The patient was discharged in the morning on 01-JUL-2008. She was hospitalized for 2.5 days (also reported as 1.5 days). On 01-JUL-2008 at 5:15 pm, the patient had a headache for 10 minutes, epigastric pain, wheezing and a seizure with unconsciousness. She was transported by emergency medical services to the emergency room. She was treated with ATIVAN. The outcomes of the epigastric pain, pseudoseizures, dermatitis, fell/huge abrasion under chin, severe headache, right arm swelling, urinary tract infection, hives and wheezing were unknown. The reporter thought her daughter's seizures were related to GARDASIL. The reporter did not think her daughter's seizures, hives and dermatitis were due to psychological problems. Additional information has been requested.