chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 46.0
Sex: F
Vaccine: VARCEL
Symptoms: Injection site pruritus
Clinical narrative: Upon receiving the injection, cl experienced itching at the site applied ice. Benadryl 25 mg PO monitored vs for 25 minutes.
Age: 38.0
Sex: F
Vaccine: VARCEL
Symptoms: Injection site erythema, Injection site pruritus, Injection site swelling
Clinical narrative: 11:45 W/in 5 minutes upon receiving Varivax pt experienced itching, swelling and redness at the injection site. Reddened area was about 3 CM, raised and swollen. Gave her Benadryl 50 mg PO at 11:50. Decreased swelling are at site. EMS here at 11:50 no transport
Age: 10.0
Sex: M
Vaccine: VARCEL
Symptoms: Erythema, Oedema, Skin warm
Clinical narrative: R upper arm red and edematous center firm to touch, hot. Augmentin 250 mg 3x 1 day. Benadryl 25 mg 2x 1 day
Age: 5.0
Sex: M
Vaccine: DTAP, HEPA, IPV, MMRV
Symptoms: Erythema
Clinical narrative: RIGHT ARM WITH LIGHT ERYTHIMIA
Age: 30.0
Sex: M
Vaccine: SMALL
Symptoms: Rash
Clinical narrative: PATIENT PRESENTED TO CLINIC WITH A NON-ITCHY, NON-TENDER RASH, NO VESICLES ON BACK. FOCUSED ON LEFT SIDE OF BACK (SAME SIDE AS INOCULATION). PATIENT NOTICED RASH ON 5/29/07.
Age: 0.33
Sex: F
Vaccine: DTAPHEPBIP, HIBV, PNC, RV5
Symptoms: Vaccination complication, Vomiting
Clinical narrative: PATIENT HAVE A REACTION TO ROTAVIRUS SHE WAS VOMITING.
Age: 19.0
Sex: F
Vaccine: HEP, HEPA, MMR
Symptoms: Pruritus, Rash
Clinical narrative: PT WAS GIVEN MMR ,HEPATITIS A, HEPATITIS B,. HAD A  REACTION OF A VERY FINE RASH AND ITCHING WITHIN 5 MINUTES OF GETTING THE VACCINES AND WAS GIVEN 50MG OF BENADRYL IM.
Sex: F
Vaccine: MMR
Symptoms: Arthralgia, Rash
Clinical narrative: Felt achy with joint pain. Fine rash on back and abdomen.
Sex: M
Vaccine: HEPA
Symptoms: Rash
Clinical narrative: Mild rash on face, neck and chest.
Age: 34.0
Sex: F
Vaccine: TTOX
Symptoms: Anxiety, Blood test normal, Chest pain, Electrocardiogram normal, Headache
Clinical narrative: Received tetanus shot on Sat. 5/19/07 within minutes of receiving the shot I got a bad headache and became nauseated. I took benadryl and antibiotic when I got home. I continued to feel bad. I took antibiotic and benadryl everyday and was having infrequent extreme anxiety. Tuesday was the last day I took benadryl for itching and Wednesday I started feeling extreme anxiety, nausea and headaches, by the afternoon my chest was hurting and my left arm too. I felt very confused and very bad. I called the Dr's office and was advised to discontinue the antibiotic they thought I was having an allergic reaction to and to take 2 benadryl.  The benadryl eased the heart pain I felt and headache eventually subsided. Everday since Sat. 5/19/07 I have had bad headache, nausea, neck tension and just generally not feeling good. Also, infrequently my chest hurts and I am not thinking clearly.  I was having none of these symptoms before I came into the office and had this shot.  I went in for itching and a bug bite that became infected and now I'm so nauseated I can not eat right and have lost 6 pounds in a week and having wicked headaches.
Age: 34.0
Sex: F
Vaccine: TTOX
Symptoms: Hypersensitivity, Nausea, Pain in extremity, Pruritus
Clinical narrative: Received tetanus shot on Sat. 5/19/07 within minutes of receiving the shot I got a bad headache and became nauseated. I took benadryl and antibiotic when I got home. I continued to feel bad. I took antibiotic and benadryl everyday and was having infrequent extreme anxiety. Tuesday was the last day I took benadryl for itching and Wednesday I started feeling extreme anxiety, nausea and headaches, by the afternoon my chest was hurting and my left arm too. I felt very confused and very bad. I called the Dr's office and was advised to discontinue the antibiotic they thought I was having an allergic reaction to and to take 2 benadryl.  The benadryl eased the heart pain I felt and headache eventually subsided. Everday since Sat. 5/19/07 I have had bad headache, nausea, neck tension and just generally not feeling good. Also, infrequently my chest hurts and I am not thinking clearly.  I was having none of these symptoms before I came into the office and had this shot.  I went in for itching and a bug bite that became infected and now I'm so nauseated I can not eat right and have lost 6 pounds in a week and having wicked headaches.
Age: 23.0
Sex: F
Vaccine: HPV4, HPV4
Symptoms: Injected limb mobility decreased, Injection site pain, Pain in extremity
Clinical narrative: Patient received vaccine on 5-8-2007 in L Deltoid. The site hurt initially but the discomfort was gone the next day. The site began hurting again 1 week later and called office and was instructed to use warm compresses and Tylenol or Advil and to call back if no better.The patient denied any redness at the site and denied fever. She states her arm did feel better but became very sore on May 27th. Hurts more at night than during the day. States she can not lift her arm above her head and getting dressed is difficult. States she feels fine otherwise, denies redness, swelling at site or fever.
Age: 23.0
Sex: F
Vaccine: HPV4, HPV4
Symptoms: Pain in extremity
Clinical narrative: Patient received vaccine on 5-8-2007 in L Deltoid. The site hurt initially but the discomfort was gone the next day. The site began hurting again 1 week later and called office and was instructed to use warm compresses and Tylenol or Advil and to call back if no better.The patient denied any redness at the site and denied fever. She states her arm did feel better but became very sore on May 27th. Hurts more at night than during the day. States she can not lift her arm above her head and getting dressed is difficult. States she feels fine otherwise, denies redness, swelling at site or fever.
Age: 28.0
Sex: U
Vaccine: HEP, TD, DT, HEP, VARCEL
Symptoms: Erythema, Myalgia, Oedema peripheral, Skin warm
Clinical narrative: Left arm was hard, warm to touch with raised red area aproximatley 2" in diameter. Her arms was examined about 48 hours after receiveing shot.  at aounrd noon she was seen in the  ER, her arm had become more tender and she felt it was hotter.  At the Er she received a Steroid shot.  Follow up phpone call on 5/30/07 she reports no pain and swelling is down quite a bit.
Age: 28.0
Sex: U
Vaccine: HEP, TD, DT, HEP, VARCEL
Symptoms: Erythema, Skin burning sensation
Clinical narrative: Left arm was hard, warm to touch with raised red area aproximatley 2" in diameter. Her arms was examined about 48 hours after receiveing shot.  at aounrd noon she was seen in the  ER, her arm had become more tender and she felt it was hotter.  At the Er she received a Steroid shot.  Follow up phpone call on 5/30/07 she reports no pain and swelling is down quite a bit.
Age: 85.0
Sex: M
Vaccine: PPV
Symptoms: Injection site reaction, Local reaction
Clinical narrative: PT REPORTED TO CLINIC AFTER RECEIVING LETTER IN MAIL ABOUT GETTING PNEUMONIA SHOT. PT DID NOT BRING HIS MEDICAL RECORD OR SHOT RECORD TO CLINIC.  PT WAS ASKED IF PREVIOUSLY VACCINATED, PT WAS UNSURE. SHOT WAS GIVEN. PT REPORTED TO CLINIC THE FOLLOWING DAY WITH LOCAL REACTION TO SITE. MD WAS NOTIFIED, PT DID NOT HAVE SIGNS OR SYMPTOMS OF ANAPHYLAXIS. PT WAS ADVISED IF SYMPTOMS WORSENED TO REPORT TO  ER FOR TREATMENT.
Age: 13.0
Sex: F
Vaccine: TDAP
Symptoms: Erythema, Local reaction, Pain, Swelling
Clinical narrative: Patient developed a localized reaction with a large amount of swelling and erythema.  Patient also complained of pain.
Age: 1.0
Sex: M
Vaccine: HEP, VARCEL
Symptoms: Varicella
Clinical narrative: VARICELLA RASH FROM HEAD TO TOE STARTED ON 5/28/2007
Age: 9.0
Sex: M
Vaccine: VARCEL
Symptoms: Injection site erythema, Injection site inflammation, Injection site warmth, Oedema peripheral
Clinical narrative: received sq varicella in L arm after site cleaned on 5/24/07 without incident. client went to play baseball after clinic.  Parent{Mom} states by 5pm site was baseball sized, red, and inflamed, and hot.  Parent states no fever.  Parent states next day entire upper arm was red and swollen. Mom states took to MD and client was placed on amoxicilan 400 mg BID for 7 days.
Age: 26.0
Sex: F
Vaccine: HEP
Symptoms: Alopecia, Dyspnoea, Fatigue, Myalgia
Clinical narrative: severe alopecia difficulty breathing muscle aches and fatigue
Age: 0.5
Sex: M
Vaccine: DTAP, HIBV, IPV, PNC, RV5, DTAP, HIBV, IPV, PNC, RV5
Symptoms: Intussusception
Clinical narrative: Patient had 3 doses of Oral Rotavirus vaccine, at 2 mo, 4 mo and 6 mo of age.  Patient was diagnosed with intussusception at 8mo of age. 5/16/07.  06/12/2007 Hospital record received for admission 5/16-18/2007 Intussusception.  Infant presented to ED with persistant vomiting, black stool, decreased po fluids, and not seeming quite himself.  He may have fallen out of bed the morning of admission.  PE: WNL except for tenderness of the abdomen with decreased BS.  Hydrostatic reduction done under general anesthesia. D/C DX: Intussusception.
Age: 0.5
Sex: M
Vaccine: DTAP, HIBV, IPV, PNC, RV5, DTAP, HIBV, IPV, PNC, RV5
Symptoms: Abdominal tenderness, Abnormal behaviour, Barium double contrast, Bowel sounds abnormal, Faeces discoloured
Clinical narrative: Patient had 3 doses of Oral Rotavirus vaccine, at 2 mo, 4 mo and 6 mo of age.  Patient was diagnosed with intussusception at 8mo of age. 5/16/07.  06/12/2007 Hospital record received for admission 5/16-18/2007 Intussusception.  Infant presented to ED with persistant vomiting, black stool, decreased po fluids, and not seeming quite himself.  He may have fallen out of bed the morning of admission.  PE: WNL except for tenderness of the abdomen with decreased BS.  Hydrostatic reduction done under general anesthesia. D/C DX: Intussusception.
Age: 0.5
Sex: M
Vaccine: DTAP, HIBV, IPV, PNC, RV5, DTAP, HIBV, IPV, PNC, RV5
Symptoms: Intussusception, Obstruction, Oral intake reduced, Tachycardia, Urinary system X-ray
Clinical narrative: Patient had 3 doses of Oral Rotavirus vaccine, at 2 mo, 4 mo and 6 mo of age.  Patient was diagnosed with intussusception at 8mo of age. 5/16/07.  06/12/2007 Hospital record received for admission 5/16-18/2007 Intussusception.  Infant presented to ED with persistant vomiting, black stool, decreased po fluids, and not seeming quite himself.  He may have fallen out of bed the morning of admission.  PE: WNL except for tenderness of the abdomen with decreased BS.  Hydrostatic reduction done under general anesthesia. D/C DX: Intussusception.
Age: 0.5
Sex: M
Vaccine: DTAP, HIBV, IPV, PNC, RV5, DTAP, HIBV, IPV, PNC, RV5
Symptoms: Vomiting
Clinical narrative: Patient had 3 doses of Oral Rotavirus vaccine, at 2 mo, 4 mo and 6 mo of age.  Patient was diagnosed with intussusception at 8mo of age. 5/16/07.  06/12/2007 Hospital record received for admission 5/16-18/2007 Intussusception.  Infant presented to ED with persistant vomiting, black stool, decreased po fluids, and not seeming quite himself.  He may have fallen out of bed the morning of admission.  PE: WNL except for tenderness of the abdomen with decreased BS.  Hydrostatic reduction done under general anesthesia. D/C DX: Intussusception.
Age: 12.0
Sex: M
Vaccine: VARCEL
Symptoms: Injection site erythema, Injection site swelling, Injection site warmth
Clinical narrative: Hot, red, swollen area of LTR at site of VAR #2 administration 1 day ago. No fever.  Otherwise healthy.  Treatment:  Ice, Ibuprofen 400-600 mg PO TID.  If much worse in 2 more days go to Urgent Care Clinic.
Age: 0.33
Sex: F
Vaccine: RV5
Symptoms: Inappropriate schedule of drug administration, Medication error, No adverse effect
Clinical narrative: RotarTeq administered Over 13 weeks old. No adverse events occured.
Age: 0.42
Sex: M
Vaccine: DTAP, HIBV, IPV, PNC, RV5, DTAP, HIBV, IPV, PNC, RV5, DTAP, HIBV, IPV, PNC, RV5
Symptoms: Adenovirus infection, Appendicectomy, Barium enema, Haematemesis, Haematochezia
Clinical narrative: Initial report received on 17 May 2007 from another manufacturer, report number WAES0705USA01932. "Information has been received from the regulatory agency (VAERS # 277125) through the government concerning a 25-week-old male with no history or pre-existing conditions who on 13-FEB-2007 was vaccinated PO with a dose of Rotateq (Lot# 656103/1166F). Concomitant vaccinations that day included a second dose of DAPTACEL (Lot # C2553AA), a second dose of ACTHIB (Lot # UF064AA), a second dose of IPOL (Lot #Z0326), and a second dose of PREVNAR (Lot #B36258B). There were no other medications. On 14-APR-2007, 60 days post vaccination, the patient presented with "coffee ground emesis" and bloody stools. The patient's mother brought him to the emergency room, when he was diagnosed with adenovirus and intussusception and was hospitalized. An adenovirus PCR was positive. The IT was unable to reduce with barium enema and was reduced with surgery. The patient was noted to be status/post an appendectomy. The patient recovered. Intussusception and adenovirus were considered to be life threatening." The manufacturer lot for the ActHIB given on 13 February 2007 is Z1040-2.
Age: 0.42
Sex: M
Vaccine: DTAP, HIBV, IPV, PNC, RV5, DTAP, HIBV, IPV, PNC, RV5, DTAP, HIBV, IPV, PNC, RV5
Symptoms: Intussusception, Polymerase chain reaction, Surgery, Virus serology test, Vomiting
Clinical narrative: Initial report received on 17 May 2007 from another manufacturer, report number WAES0705USA01932. "Information has been received from the regulatory agency (VAERS # 277125) through the government concerning a 25-week-old male with no history or pre-existing conditions who on 13-FEB-2007 was vaccinated PO with a dose of Rotateq (Lot# 656103/1166F). Concomitant vaccinations that day included a second dose of DAPTACEL (Lot # C2553AA), a second dose of ACTHIB (Lot # UF064AA), a second dose of IPOL (Lot #Z0326), and a second dose of PREVNAR (Lot #B36258B). There were no other medications. On 14-APR-2007, 60 days post vaccination, the patient presented with "coffee ground emesis" and bloody stools. The patient's mother brought him to the emergency room, when he was diagnosed with adenovirus and intussusception and was hospitalized. An adenovirus PCR was positive. The IT was unable to reduce with barium enema and was reduced with surgery. The patient was noted to be status/post an appendectomy. The patient recovered. Intussusception and adenovirus were considered to be life threatening." The manufacturer lot for the ActHIB given on 13 February 2007 is Z1040-2.
Age: 0.42
Sex: M
Vaccine: DTAP, HIBV, IPV, PNC, RV5, DTAP, HIBV, IPV, PNC, RV5, DTAP, HIBV, IPV, PNC, RV5
Symptoms: Intussusception, Nasal aspiration, Surgery
Clinical narrative: Initial report received on 17 May 2007 from another manufacturer, report number WAES0705USA01932. "Information has been received from the regulatory agency (VAERS # 277125) through the government concerning a 25-week-old male with no history or pre-existing conditions who on 13-FEB-2007 was vaccinated PO with a dose of Rotateq (Lot# 656103/1166F). Concomitant vaccinations that day included a second dose of DAPTACEL (Lot # C2553AA), a second dose of ACTHIB (Lot # UF064AA), a second dose of IPOL (Lot #Z0326), and a second dose of PREVNAR (Lot #B36258B). There were no other medications. On 14-APR-2007, 60 days post vaccination, the patient presented with "coffee ground emesis" and bloody stools. The patient's mother brought him to the emergency room, when he was diagnosed with adenovirus and intussusception and was hospitalized. An adenovirus PCR was positive. The IT was unable to reduce with barium enema and was reduced with surgery. The patient was noted to be status/post an appendectomy. The patient recovered. Intussusception and adenovirus were considered to be life threatening." The manufacturer lot for the ActHIB given on 13 February 2007 is Z1040-2.
Age: 0.42
Sex: M
Vaccine: DTAP, HIBV, IPV, PNC, RV5, DTAP, HIBV, IPV, PNC, RV5, DTAP, HIBV, IPV, PNC, RV5
Symptoms: Adenovirus infection, Barium enema, Haematemesis, Haematochezia, Intussusception
Clinical narrative: Initial report received on 17 May 2007 from another manufacturer, report number WAES0705USA01932. "Information has been received from the regulatory agency (VAERS # 277125) through the government concerning a 25-week-old male with no history or pre-existing conditions who on 13-FEB-2007 was vaccinated PO with a dose of Rotateq (Lot# 656103/1166F). Concomitant vaccinations that day included a second dose of DAPTACEL (Lot # C2553AA), a second dose of ACTHIB (Lot # UF064AA), a second dose of IPOL (Lot #Z0326), and a second dose of PREVNAR (Lot #B36258B). There were no other medications. On 14-APR-2007, 60 days post vaccination, the patient presented with "coffee ground emesis" and bloody stools. The patient's mother brought him to the emergency room, when he was diagnosed with adenovirus and intussusception and was hospitalized. An adenovirus PCR was positive. The IT was unable to reduce with barium enema and was reduced with surgery. The patient was noted to be status/post an appendectomy. The patient recovered. Intussusception and adenovirus were considered to be life threatening." The manufacturer lot for the ActHIB given on 13 February 2007 is Z1040-2.
Age: 0.42
Sex: M
Vaccine: DTAP, HIBV, IPV, PNC, RV5, DTAP, HIBV, IPV, PNC, RV5, DTAP, HIBV, IPV, PNC, RV5
Symptoms: Laparotomy, Nasal aspiration, Virus serology test
Clinical narrative: Initial report received on 17 May 2007 from another manufacturer, report number WAES0705USA01932. "Information has been received from the regulatory agency (VAERS # 277125) through the government concerning a 25-week-old male with no history or pre-existing conditions who on 13-FEB-2007 was vaccinated PO with a dose of Rotateq (Lot# 656103/1166F). Concomitant vaccinations that day included a second dose of DAPTACEL (Lot # C2553AA), a second dose of ACTHIB (Lot # UF064AA), a second dose of IPOL (Lot #Z0326), and a second dose of PREVNAR (Lot #B36258B). There were no other medications. On 14-APR-2007, 60 days post vaccination, the patient presented with "coffee ground emesis" and bloody stools. The patient's mother brought him to the emergency room, when he was diagnosed with adenovirus and intussusception and was hospitalized. An adenovirus PCR was positive. The IT was unable to reduce with barium enema and was reduced with surgery. The patient was noted to be status/post an appendectomy. The patient recovered. Intussusception and adenovirus were considered to be life threatening." The manufacturer lot for the ActHIB given on 13 February 2007 is Z1040-2.
Age: 0.2
Sex: F
Vaccine: DTAP, HBHEPB, IPV, PNC, RV5, DTAP, HBHEPB, IPV, PNC, RV5, DTAP, HBHEPB, IPV, PNC, RV5
Symptoms: Crying, Culture stool, Diarrhoea, Haematochezia, Infantile spitting up
Clinical narrative: SERIOUSNESS CRITERIA: OTHER - MEDICALLY SIGNIFICANT. Initial report received on 17 May 2007 from another manufacturer, report# WAES0705USA00840. 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 9 week old health female with no known allergies or medical history who on 23-APR-2007 was vaccinated with Rotateq 2mL PO first dose ( LOT # 656192/0022U). Concomitant therapy included PREVNAR, IPOL, COMVAX and DAPTACEL. On 29-APR-2007 the patient experienced diarrhea. The physician reported that the loose stools lasted about" six days". On 01-MAY-2007 the patient had two bloody stool and the rest were "okay". The physician reported that the patient was also more irritable during the time of the events. Laboratory diagnostic studies which were performed included a guaiac stool, rotavirus rapid antigen, giardia and cryptosporidium cultures and stool cultures. It was reported that the patient sought unspecified medical attention. The physician reported the patient recovered. Upon internal review, bloody stool was determined to be an other important medical event."
Age: 0.2
Sex: F
Vaccine: DTAP, HBHEPB, IPV, PNC, RV5, DTAP, HBHEPB, IPV, PNC, RV5, DTAP, HBHEPB, IPV, PNC, RV5
Symptoms: Irritability, Occult blood negative, Rotavirus test negative, Virus culture
Clinical narrative: SERIOUSNESS CRITERIA: OTHER - MEDICALLY SIGNIFICANT. Initial report received on 17 May 2007 from another manufacturer, report# WAES0705USA00840. 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 9 week old health female with no known allergies or medical history who on 23-APR-2007 was vaccinated with Rotateq 2mL PO first dose ( LOT # 656192/0022U). Concomitant therapy included PREVNAR, IPOL, COMVAX and DAPTACEL. On 29-APR-2007 the patient experienced diarrhea. The physician reported that the loose stools lasted about" six days". On 01-MAY-2007 the patient had two bloody stool and the rest were "okay". The physician reported that the patient was also more irritable during the time of the events. Laboratory diagnostic studies which were performed included a guaiac stool, rotavirus rapid antigen, giardia and cryptosporidium cultures and stool cultures. It was reported that the patient sought unspecified medical attention. The physician reported the patient recovered. Upon internal review, bloody stool was determined to be an other important medical event."
Age: 0.2
Sex: F
Vaccine: DTAP, HBHEPB, IPV, PNC, RV5, DTAP, HBHEPB, IPV, PNC, RV5, DTAP, HBHEPB, IPV, PNC, RV5
Symptoms: Culture stool, Diarrhoea, Haematochezia, Irritability, Occult blood
Clinical narrative: SERIOUSNESS CRITERIA: OTHER - MEDICALLY SIGNIFICANT. Initial report received on 17 May 2007 from another manufacturer, report# WAES0705USA00840. 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 9 week old health female with no known allergies or medical history who on 23-APR-2007 was vaccinated with Rotateq 2mL PO first dose ( LOT # 656192/0022U). Concomitant therapy included PREVNAR, IPOL, COMVAX and DAPTACEL. On 29-APR-2007 the patient experienced diarrhea. The physician reported that the loose stools lasted about" six days". On 01-MAY-2007 the patient had two bloody stool and the rest were "okay". The physician reported that the patient was also more irritable during the time of the events. Laboratory diagnostic studies which were performed included a guaiac stool, rotavirus rapid antigen, giardia and cryptosporidium cultures and stool cultures. It was reported that the patient sought unspecified medical attention. The physician reported the patient recovered. Upon internal review, bloody stool was determined to be an other important medical event."
Age: 0.2
Sex: F
Vaccine: DTAP, HBHEPB, IPV, PNC, RV5, DTAP, HBHEPB, IPV, PNC, RV5, DTAP, HBHEPB, IPV, PNC, RV5
Symptoms: Rotavirus test
Clinical narrative: SERIOUSNESS CRITERIA: OTHER - MEDICALLY SIGNIFICANT. Initial report received on 17 May 2007 from another manufacturer, report# WAES0705USA00840. 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 9 week old health female with no known allergies or medical history who on 23-APR-2007 was vaccinated with Rotateq 2mL PO first dose ( LOT # 656192/0022U). Concomitant therapy included PREVNAR, IPOL, COMVAX and DAPTACEL. On 29-APR-2007 the patient experienced diarrhea. The physician reported that the loose stools lasted about" six days". On 01-MAY-2007 the patient had two bloody stool and the rest were "okay". The physician reported that the patient was also more irritable during the time of the events. Laboratory diagnostic studies which were performed included a guaiac stool, rotavirus rapid antigen, giardia and cryptosporidium cultures and stool cultures. It was reported that the patient sought unspecified medical attention. The physician reported the patient recovered. Upon internal review, bloody stool was determined to be an other important medical event."
Age: 53.0
Sex: F
Vaccine: FLUX
Symptoms: Cervical spinal stenosis, Hypoaesthesia, Injection site pain, Muscular weakness, Nuclear magnetic resonance imaging normal
Clinical narrative: My left arm, where the vac. was given at a strange angle, has hurt ever since getting the vac. (like someone has punched me really hard in the upper left arm) and results in staggering pain and weakness in the left arm, with tingling like a "funny bone being hit" going down the whole arm and hand and fingers.  This has been going on ever since getting the vac. and increasingly getting worse.  An MRI was done that shows only "age associated" closing of the area in my cervical spine, but does not explain the weakness, pain and numbing sensations I experience every day.  I highly suspect it was the vaccination because that is when it begun.  I wonder if other people have had this reaction and wanted to report it. I also have broken out with sores all over my legs, buttocks, and now spreading to my arms... tried antibiotics, salves, creams, atavan.. not helping... Further information can only come from my clinic where I received the flu shot this past season. Exact date would have to be gotten from the clinic/doctor's office. 8/1/07-records received for DOS 8/3/06 and 6/25/07-C/O tingling numbeness in left arm.  1/4/10 Pain persist in upper left arm and symptoms in addition ot pain are; numbness, tingling, pain and "itchiness" going doe the arm and also thumb and index finger possible radial nerve was hit, I was told. Still seeing doctors for this.
Age: 53.0
Sex: F
Vaccine: FLUX
Symptoms: Paraesthesia, Pruritus, Skin lesion
Clinical narrative: My left arm, where the vac. was given at a strange angle, has hurt ever since getting the vac. (like someone has punched me really hard in the upper left arm) and results in staggering pain and weakness in the left arm, with tingling like a "funny bone being hit" going down the whole arm and hand and fingers.  This has been going on ever since getting the vac. and increasingly getting worse.  An MRI was done that shows only "age associated" closing of the area in my cervical spine, but does not explain the weakness, pain and numbing sensations I experience every day.  I highly suspect it was the vaccination because that is when it begun.  I wonder if other people have had this reaction and wanted to report it. I also have broken out with sores all over my legs, buttocks, and now spreading to my arms... tried antibiotics, salves, creams, atavan.. not helping... Further information can only come from my clinic where I received the flu shot this past season. Exact date would have to be gotten from the clinic/doctor's office. 8/1/07-records received for DOS 8/3/06 and 6/25/07-C/O tingling numbeness in left arm.  1/4/10 Pain persist in upper left arm and symptoms in addition ot pain are; numbness, tingling, pain and "itchiness" going doe the arm and also thumb and index finger possible radial nerve was hit, I was told. Still seeing doctors for this.
Age: 5.0
Sex: M
Vaccine: DTAP, HEP, IPV, MMR, VARCEL
Symptoms: Cold compress therapy, Erythema, Oedema peripheral
Clinical narrative: PT RIGHT ARM WAS RED, WAR AND SWOLLEN. PT'S MOTHER APPLIED A WARM AND COOL COMPRESS. CHILD WAS GIVEN CHILDRE'S TYLENOL AND MOTRIN.
Age: 12.0
Sex: F
Vaccine: HEPA
Symptoms: Abdominal pain, Diarrhoea, Eating disorder
Clinical narrative: abdominal pain particularly center and right side; dark watery diarrhea; unable to consistently maintain food consumption without having diarrhea. Two on-call doctors notified & gave recommendations, left messages for pediatrician to contact me(call has not been returned yet); nurse notified & gave recommendations. Recommendations were to treat with dry starchy bland diet, water, and electrolyte liquids. child is always hungry. * I do not know the name of the manufacturer- pediatrician has not yet returned my calls.
Sex: U
Vaccine: VARZOS
Symptoms: Pneumonia
Clinical narrative: Information has been received from a physician concerning a patient who was vaccinated with a dose of Zostavax. It was reported that the patient was healthy and after vaccination, the patient ended in hospital with pneumonia. At the time of report the patient was recovered. Additional information has been requested. This is one of several reports received from the same source.
Age: 15.0
Sex: F
Vaccine: HPV4
Symptoms: Encephalitis
Clinical narrative: Information has been received from physician concerning a 15 year old female who was vaccinated with Gardasil. Subsequently the patient may have experienced encephalitis and was hospitalized. The duration of the stay was not provided. The physician reporting was not the physician who administered the vaccine but the treating physician. At the time of the report the patient had recovered. Additional information has been requested.
Age: 30.0
Sex: F
Vaccine: PPV, TTOX
Symptoms: Arthralgia, Cellulitis, Cold compress therapy, Erythema, Injected limb mobility decreased
Clinical narrative: Initial and follow up information has been received from a registered nurse and a consumer concerning his 30 year old wife who works in healthcare, with a history of pneumonia in 1996, 2005 and 2006 who on the morning of 14-MAY-2007 was vaccinated with Pneumovax 23 (lot # 655500/1005F) in the right arm, IM. Concomitantly with tetanus toxoid in the left arm. On 14-MAY-2007 by late afternoon or evening the patient experienced right upper arm soreness, swelling, stiffness and decreased range of motion. A physician saw the patient on 14-MAY-2007 and noted normal strength, shoulder was edematous and tender to palpation at the injection site. There was tenderness in forward flexion. The patient was given Celebrex and told to ice the injection site area. On 15-MAY-2007 the patient continued to complain of right shoulder pain. The patient was reporting swelling of the right hand. The patient reported the pain intensity was an 8 out of 10. The physician noted joint pain and swelling. There was decreased motion in the shoulder, mild erythema, warm to touch of the upper shoulder and deltoid muscle. The right hand noted with mild erythema and edema. Normal range of motion and strength. No joint enlargement or tenderness. The diagnosis was cellulitis. The patient was treated with Cefadin 500 mg 3 times daily and Lortab 5 mg every 4 to 6 hours as needed for pain. The patient was given an injection of Decadron 4 mg and Kenalog 40. The patient reported to the nurse on 17-MAY-2007 the arm is better. On 21-MAY-2007 the consumer reported that his wife did not experience swelling and pain because of the vaccine, but because of the location. Consumer reported that the vaccine was administered in the right shoulder. At the time of the report, the patient was recovering. The reporting registered nurse considered stiffness, decreased range of motion, cellulitis, and joint pain to be disabling since the patient had missed work. Additional information has been requested.
Age: 30.0
Sex: F
Vaccine: PPV, TTOX
Symptoms: Injection site pain, Injection site swelling, Injection site warmth, Joint range of motion decreased, Joint swelling
Clinical narrative: Initial and follow up information has been received from a registered nurse and a consumer concerning his 30 year old wife who works in healthcare, with a history of pneumonia in 1996, 2005 and 2006 who on the morning of 14-MAY-2007 was vaccinated with Pneumovax 23 (lot # 655500/1005F) in the right arm, IM. Concomitantly with tetanus toxoid in the left arm. On 14-MAY-2007 by late afternoon or evening the patient experienced right upper arm soreness, swelling, stiffness and decreased range of motion. A physician saw the patient on 14-MAY-2007 and noted normal strength, shoulder was edematous and tender to palpation at the injection site. There was tenderness in forward flexion. The patient was given Celebrex and told to ice the injection site area. On 15-MAY-2007 the patient continued to complain of right shoulder pain. The patient was reporting swelling of the right hand. The patient reported the pain intensity was an 8 out of 10. The physician noted joint pain and swelling. There was decreased motion in the shoulder, mild erythema, warm to touch of the upper shoulder and deltoid muscle. The right hand noted with mild erythema and edema. Normal range of motion and strength. No joint enlargement or tenderness. The diagnosis was cellulitis. The patient was treated with Cefadin 500 mg 3 times daily and Lortab 5 mg every 4 to 6 hours as needed for pain. The patient was given an injection of Decadron 4 mg and Kenalog 40. The patient reported to the nurse on 17-MAY-2007 the arm is better. On 21-MAY-2007 the consumer reported that his wife did not experience swelling and pain because of the vaccine, but because of the location. Consumer reported that the vaccine was administered in the right shoulder. At the time of the report, the patient was recovering. The reporting registered nurse considered stiffness, decreased range of motion, cellulitis, and joint pain to be disabling since the patient had missed work. Additional information has been requested.
Age: 30.0
Sex: F
Vaccine: PPV, TTOX
Symptoms: Musculoskeletal discomfort, Musculoskeletal pain, Musculoskeletal stiffness, Oedema peripheral, Pain in extremity
Clinical narrative: Initial and follow up information has been received from a registered nurse and a consumer concerning his 30 year old wife who works in healthcare, with a history of pneumonia in 1996, 2005 and 2006 who on the morning of 14-MAY-2007 was vaccinated with Pneumovax 23 (lot # 655500/1005F) in the right arm, IM. Concomitantly with tetanus toxoid in the left arm. On 14-MAY-2007 by late afternoon or evening the patient experienced right upper arm soreness, swelling, stiffness and decreased range of motion. A physician saw the patient on 14-MAY-2007 and noted normal strength, shoulder was edematous and tender to palpation at the injection site. There was tenderness in forward flexion. The patient was given Celebrex and told to ice the injection site area. On 15-MAY-2007 the patient continued to complain of right shoulder pain. The patient was reporting swelling of the right hand. The patient reported the pain intensity was an 8 out of 10. The physician noted joint pain and swelling. There was decreased motion in the shoulder, mild erythema, warm to touch of the upper shoulder and deltoid muscle. The right hand noted with mild erythema and edema. Normal range of motion and strength. No joint enlargement or tenderness. The diagnosis was cellulitis. The patient was treated with Cefadin 500 mg 3 times daily and Lortab 5 mg every 4 to 6 hours as needed for pain. The patient was given an injection of Decadron 4 mg and Kenalog 40. The patient reported to the nurse on 17-MAY-2007 the arm is better. On 21-MAY-2007 the consumer reported that his wife did not experience swelling and pain because of the vaccine, but because of the location. Consumer reported that the vaccine was administered in the right shoulder. At the time of the report, the patient was recovering. The reporting registered nurse considered stiffness, decreased range of motion, cellulitis, and joint pain to be disabling since the patient had missed work. Additional information has been requested.
Age: 30.0
Sex: F
Vaccine: PPV, TTOX
Symptoms: Swelling, Tenderness
Clinical narrative: Initial and follow up information has been received from a registered nurse and a consumer concerning his 30 year old wife who works in healthcare, with a history of pneumonia in 1996, 2005 and 2006 who on the morning of 14-MAY-2007 was vaccinated with Pneumovax 23 (lot # 655500/1005F) in the right arm, IM. Concomitantly with tetanus toxoid in the left arm. On 14-MAY-2007 by late afternoon or evening the patient experienced right upper arm soreness, swelling, stiffness and decreased range of motion. A physician saw the patient on 14-MAY-2007 and noted normal strength, shoulder was edematous and tender to palpation at the injection site. There was tenderness in forward flexion. The patient was given Celebrex and told to ice the injection site area. On 15-MAY-2007 the patient continued to complain of right shoulder pain. The patient was reporting swelling of the right hand. The patient reported the pain intensity was an 8 out of 10. The physician noted joint pain and swelling. There was decreased motion in the shoulder, mild erythema, warm to touch of the upper shoulder and deltoid muscle. The right hand noted with mild erythema and edema. Normal range of motion and strength. No joint enlargement or tenderness. The diagnosis was cellulitis. The patient was treated with Cefadin 500 mg 3 times daily and Lortab 5 mg every 4 to 6 hours as needed for pain. The patient was given an injection of Decadron 4 mg and Kenalog 40. The patient reported to the nurse on 17-MAY-2007 the arm is better. On 21-MAY-2007 the consumer reported that his wife did not experience swelling and pain because of the vaccine, but because of the location. Consumer reported that the vaccine was administered in the right shoulder. At the time of the report, the patient was recovering. The reporting registered nurse considered stiffness, decreased range of motion, cellulitis, and joint pain to be disabling since the patient had missed work. Additional information has been requested.
Age: 5.0
Sex: U
Vaccine: MMRV
Symptoms: Anaphylactic shock
Clinical narrative: Information has been received from nurse concerning a 5 year old patient who was vaccinated with a dose of ProQuad. It was reported that the patient went into anaphylactic shock, a few minutes after receiving vaccine and was eventually taken to hospital after receiving two doses of epinephrine (Epi Pen).  Upon internal review, anaphylactic shock was considered to be an other important medical event. Additional information will be provided if available. This is one of several reports received from the same source.
Age: 11.0
Sex: F
Vaccine: HEPA, VARCEL
Symptoms: Peripheral nerve palsy
Clinical narrative: Information has been received from a physician concerning an 11 year old female who on unspecified date, was vaccinated with a first and second (SQ, booster) dose of Varivax. Concomitant vaccinations included, the first dose of Vaqta generic (manufacturer unknown). Subsequently, "two weeks post vaccination", the vaccinating physicians office referred the patient to the specialist physician as the patient developed "long horasic (or thoracic) nerve palsy with scapular winging". Unspecified medical attention was sought. No product quality complaint was involved. The patients' adverse events were considered to be other important medical events. Additional information has been requested.
Age: 3.0
Sex: M
Vaccine: VARCEL
Symptoms: Anaphylactoid reaction, Angiogram, Body temperature increased, Cough, Flushing
Clinical narrative: Information has been received from a physician concerning a 36 month old male patient with a history of gastrointestinal problems, absent left kidney and ureteropelvic junction obstruction who on 30-MAR-2007 was vaccinated with first dose of Varivax (Lot # 654756/1335F). Concomitant therapy included amoxicillin for an unspecified infection. On 30-MAR-2007, immediately after vaccination, the patient experienced "allergic/anaphylactic type of reaction". The patient was treated with epinephrine and Benadryl and then went to the emergency department of a local hospital. He was at the emergency department for 6 hours and was not admitted as an in-patient. The patient was prescribed prednisone. A product quality complaint was not involved. Allergic/anaphylactic type of reaction was considered to be an other important medical event by the reporter. Additional information has been requested. Additional information has been received from the physician's office supervisor who stated that patient had no fever, upper rspiratory infection or cough at the time of vaccination. on 30-MAR-2007 10 minutes after vaccination the patient went back to the car with his mother. In car the patient told his mother that the was not feeling well and he was pale. The patient was brought back into the office and he fainted in the exam room. The patient was vomiting, coughing and wheezing. The patient was given albuterol nebulizer, 0.5 ml. Three to 5 minutes later patient felt little better, but was still pale and lethargic with a flushed rash. The patient was no longer vomiting, his chest was clear and he had no rib retraction. The patient was given epinephrine 0.14 ml IM and BENADRYL 15 mg IM. Oxygen 5L was also started. The patient's vital signs were temperature 98.9 degree. O2 saturation 98% heart rate 80, respiration 25. After 5 more minutes the patient was more alert but still tired. After another 15 minutes the patient was again very sleepy, and the was taken to ER. On arrival he was alert and tired. The patient had a chest computed tomography angiography (CTA) and "CVRRR" (result not reproted). The skin flush and rash improved. The patient was diagnosed as having an anaphylactic reaction to vaccine. The patient recovered on same day. No further information is expected.
Age: 3.0
Sex: M
Vaccine: VARCEL
Symptoms: Hypersensitivity, Lethargy, Malaise, Pallor, Syncope
Clinical narrative: Information has been received from a physician concerning a 36 month old male patient with a history of gastrointestinal problems, absent left kidney and ureteropelvic junction obstruction who on 30-MAR-2007 was vaccinated with first dose of Varivax (Lot # 654756/1335F). Concomitant therapy included amoxicillin for an unspecified infection. On 30-MAR-2007, immediately after vaccination, the patient experienced "allergic/anaphylactic type of reaction". The patient was treated with epinephrine and Benadryl and then went to the emergency department of a local hospital. He was at the emergency department for 6 hours and was not admitted as an in-patient. The patient was prescribed prednisone. A product quality complaint was not involved. Allergic/anaphylactic type of reaction was considered to be an other important medical event by the reporter. Additional information has been requested. Additional information has been received from the physician's office supervisor who stated that patient had no fever, upper rspiratory infection or cough at the time of vaccination. on 30-MAR-2007 10 minutes after vaccination the patient went back to the car with his mother. In car the patient told his mother that the was not feeling well and he was pale. The patient was brought back into the office and he fainted in the exam room. The patient was vomiting, coughing and wheezing. The patient was given albuterol nebulizer, 0.5 ml. Three to 5 minutes later patient felt little better, but was still pale and lethargic with a flushed rash. The patient was no longer vomiting, his chest was clear and he had no rib retraction. The patient was given epinephrine 0.14 ml IM and BENADRYL 15 mg IM. Oxygen 5L was also started. The patient's vital signs were temperature 98.9 degree. O2 saturation 98% heart rate 80, respiration 25. After 5 more minutes the patient was more alert but still tired. After another 15 minutes the patient was again very sleepy, and the was taken to ER. On arrival he was alert and tired. The patient had a chest computed tomography angiography (CTA) and "CVRRR" (result not reproted). The skin flush and rash improved. The patient was diagnosed as having an anaphylactic reaction to vaccine. The patient recovered on same day. No further information is expected.
Age: 3.0
Sex: M
Vaccine: VARCEL
Symptoms: Vomiting, Wheezing
Clinical narrative: Information has been received from a physician concerning a 36 month old male patient with a history of gastrointestinal problems, absent left kidney and ureteropelvic junction obstruction who on 30-MAR-2007 was vaccinated with first dose of Varivax (Lot # 654756/1335F). Concomitant therapy included amoxicillin for an unspecified infection. On 30-MAR-2007, immediately after vaccination, the patient experienced "allergic/anaphylactic type of reaction". The patient was treated with epinephrine and Benadryl and then went to the emergency department of a local hospital. He was at the emergency department for 6 hours and was not admitted as an in-patient. The patient was prescribed prednisone. A product quality complaint was not involved. Allergic/anaphylactic type of reaction was considered to be an other important medical event by the reporter. Additional information has been requested. Additional information has been received from the physician's office supervisor who stated that patient had no fever, upper rspiratory infection or cough at the time of vaccination. on 30-MAR-2007 10 minutes after vaccination the patient went back to the car with his mother. In car the patient told his mother that the was not feeling well and he was pale. The patient was brought back into the office and he fainted in the exam room. The patient was vomiting, coughing and wheezing. The patient was given albuterol nebulizer, 0.5 ml. Three to 5 minutes later patient felt little better, but was still pale and lethargic with a flushed rash. The patient was no longer vomiting, his chest was clear and he had no rib retraction. The patient was given epinephrine 0.14 ml IM and BENADRYL 15 mg IM. Oxygen 5L was also started. The patient's vital signs were temperature 98.9 degree. O2 saturation 98% heart rate 80, respiration 25. After 5 more minutes the patient was more alert but still tired. After another 15 minutes the patient was again very sleepy, and the was taken to ER. On arrival he was alert and tired. The patient had a chest computed tomography angiography (CTA) and "CVRRR" (result not reproted). The skin flush and rash improved. The patient was diagnosed as having an anaphylactic reaction to vaccine. The patient recovered on same day. No further information is expected.
Age: 64.0
Sex: M
Vaccine: VARZOS, VARZOS
Symptoms: Encephalitis
Clinical narrative: Information has been received from a physician concerning a male patient "in his 60's" who at the end of December 2006 was vaccinated with a dose of Zostavax. Three months later at the end of March 2007, the patient experienced encephalitis. It was reported that the patient had no other history of precipitating factors for the encephalitis. Upon internal review,the encephalitis was considered to be an other important medical event. Additional information has been requested. 6/27/07-records received from facility for DOS 5/30-6/15/07-DC DX: Dysphagia unknown etiology. BPH and Anxiety. Generalized weakness, intubated for respiratory failure and PNA. Subsequently extubated. Developed right sided facial numbness then progressed with flu symptoms and vertigo three weeks prior to admission. Admitted with extreme weakness, vertigo and nausea.
Age: 64.0
Sex: M
Vaccine: VARZOS, VARZOS
Symptoms: Computerised tomogram, Dysphagia, Electrocardiogram, Encephalopathy, Laboratory test
Clinical narrative: Information has been received from a physician concerning a male patient "in his 60's" who at the end of December 2006 was vaccinated with a dose of Zostavax. Three months later at the end of March 2007, the patient experienced encephalitis. It was reported that the patient had no other history of precipitating factors for the encephalitis. Upon internal review,the encephalitis was considered to be an other important medical event. Additional information has been requested. 6/27/07-records received from facility for DOS 5/30-6/15/07-DC DX: Dysphagia unknown etiology. BPH and Anxiety. Generalized weakness, intubated for respiratory failure and PNA. Subsequently extubated. Developed right sided facial numbness then progressed with flu symptoms and vertigo three weeks prior to admission. Admitted with extreme weakness, vertigo and nausea.
Age: 64.0
Sex: M
Vaccine: VARZOS, VARZOS
Symptoms: Mechanical ventilation, Nuclear magnetic resonance imaging, Respiratory distress, Tracheostomy, X-ray
Clinical narrative: Information has been received from a physician concerning a male patient "in his 60's" who at the end of December 2006 was vaccinated with a dose of Zostavax. Three months later at the end of March 2007, the patient experienced encephalitis. It was reported that the patient had no other history of precipitating factors for the encephalitis. Upon internal review,the encephalitis was considered to be an other important medical event. Additional information has been requested. 6/27/07-records received from facility for DOS 5/30-6/15/07-DC DX: Dysphagia unknown etiology. BPH and Anxiety. Generalized weakness, intubated for respiratory failure and PNA. Subsequently extubated. Developed right sided facial numbness then progressed with flu symptoms and vertigo three weeks prior to admission. Admitted with extreme weakness, vertigo and nausea.