chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 6.0
Sex: M
Vaccine: DTAPIPV, MMR, VARCEL
Symptoms: Injection site erythema, Injection site swelling
Clinical narrative: Severe swelling/redness at site of injection.
Age: 5.0
Sex: F
Vaccine: DTAPIPV, MMR, VARCEL
Symptoms: Injection site erythema, Injection site swelling
Clinical narrative: Severe swelling/redness at site of injection.
Age: 0.34
Sex: F
Vaccine: DTAPIPVHIB, PNC13, RV5
Symptoms: Crying, Screaming
Clinical narrative: Inconsolable screaming/crying, began approximately 3 hours after receiving vaccines, gave TYLENOL 80 mg after 30 minutes of screaming, child calmed within another 30 minutes and fell asleep - OK when awoke later.
Age: 11.0
Sex: F
Vaccine: HPV4, MNQ, TDAP
Symptoms: Fall, Pallor
Clinical narrative: Minor patient received 3 vaccinations on date and time noted below. About 10 minutes later, patient fell to the ground and appeared to have fainted per witnesses. She was immediately responsive following the fall, but appeared pale in the face and lips. She was laid flat on her back with her legs above her heart. Her color returned quickly to her face and she denied feeling dizzy. She was also assessed by paramedics who were called to the scene.
Age: 13.0
Sex: M
Vaccine: HEPA, VARCEL
Symptoms: Rash, Rash erythematous, Rash pruritic
Clinical narrative: Raised red rash with itching upon awakening 8/17/10. Progressively moving from fingertips to wrists/both hands. Has not yet treated the symptoms with OTC meds.
Age: 65.0
Sex: F
Vaccine: PPV
Symptoms: Blood test, Cellulitis, Injection site swelling, Injection site urticaria, Injection site warmth
Clinical narrative: Upper arm very sore, redness, welt, swelling spreading to all upper arm hot to touch. Antibiotics: cephalexin 500 mg for 10 days (4 capsules a day) elevate arm, ice pack. Doctor at Urgent Care identified it as cellulitis infection.
Age: 56.0
Sex: F
Vaccine: FLU(H1N1), FLU3
Symptoms: Musculoskeletal pain, Pain
Clinical narrative: After receiving the H1N1 injection in my right shoulder on 10/29/2009 the pain has continued everyday. I was seen by an orthopedic physician who ordered physical therapy. I had 10 sessions with the physical therapist and continue to have discomfort everyday depending on certain movements of my right shoulder.
Age: 5.0
Sex: F
Vaccine: DTAP, IPV, MMR, VARCEL
Symptoms: Urticaria
Clinical narrative: Child received vaccines on 8/24/10. On 8/25/10 MOC called and reported client developed hives on legs/stomach. Referral to MD.
Age: 3.0
Sex: M
Vaccine: PNC13
Symptoms: Injection site erythema, Injection site pain, Injection site swelling
Clinical narrative: Red swollen area on (L) thigh around injection site approx. 4 cm x 2 cm. Mild tenderness with palpation.
Age: 16.0
Sex: F
Vaccine: HEPA, HPV4, MNQ, TDAP
Symptoms: Dizziness, Loss of consciousness, Pallor
Clinical narrative: Left clinic feeling fine, mother stated within a few minutes pt c/o feeling lightheaded, became pale and passed out mother drove back to clinic. Pt observed in clinic x 30 min, given juice and crackers and reclined. No further reactions noted in clinic.
Age: 16.0
Sex: M
Vaccine: HEPA, MNQ, VARCEL
Symptoms: Fall, Hyperhidrosis, Pallor
Clinical narrative: Was exiting building when fell to floor. Mom at side. Pt was pale, diaphoretic and alert by the time nurse arrived minute later. Pt observed in clinic for 30 minutes. Given juice, cold wet towels applied to neck & forehead, reclined. No further reaction noted in clinic.
Age: 87.0
Sex: M
Vaccine: FLU3
Symptoms: Eye haemorrhage
Clinical narrative: Pt woke up with a broken blood vessel in the eye-- the day after the shot.
Age: 1.17
Sex: M
Vaccine: MMR
Symptoms: Measles, Rash generalised
Clinical narrative: FOLLOWING MMR VACCINE ADMINISTRATION, MOM REPORTS CHILD DEVELOPED A RASH, EVENTUALLY OVER WHOLE BODY, SIMILAR TO MEASLES.  THIS WAS CONFIRMED BY HER PHYSICIAN.
Age: 69.0
Sex: F
Vaccine: VARZOS
Symptoms: Allergy to vaccine, Pruritus, Rash erythematous, Rash vesicular
Clinical narrative: itching, red raised patches of blister like rash
Age: 67.0
Sex: F
Vaccine: VARZOS
Symptoms: Erythema, Pruritus, Rash vesicular
Clinical narrative: zoster-like rash, itching and redness
Age: 5.0
Sex: M
Vaccine: DTAPIPV, MMR, VARCEL
Symptoms: Body temperature increased, Injection site erythema, Injection site reaction, Injection site warmth, Local reaction
Clinical narrative: LOCALIZED REACTION AT INJECTION SITE 24 HOURS POST INJECTION.  AREA WORSENED AT 48 HOURS POST VACCINATION.  12CM X 10.5CM LUA.  TEMP 99.5 F.  GOOD MOVEMENT. WARM TO TOUCH, RED.
Age: 0.18
Sex: M
Vaccine: DTAP, HEP, HIBV, OPV, PER
Symptoms: Cough, Sneezing, Vomiting
Clinical narrative: Coughing, sneezing, vomiting
Age: 27.0
Sex: F
Vaccine: PPV
Symptoms: Injection site erythema, Injection site pruritus, Injection site swelling
Clinical narrative: pruritus, erythema and swelling of the deltoid at location of the Pneumovax shot.
Age: 18.0
Sex: M
Vaccine: HEP, IPV, TDAP
Symptoms: Cold sweat, Dyskinesia, Loss of consciousness, Pallor
Clinical narrative: Loss of consciousness & jerking of arms & legs lasting less than 1 minute. Skin pallor & clammy. 10:40 am B/P 88/40 P. 52 in supine position. 10:42 am B/P 90/60 P. 50. 10:44 am P. 56. 10:46 am B/P 98/58. 10:52 B/P 98/58 P. 56. 11:00am B/P 98/58 P. 56 sitting down.
Age: 22.0
Sex: F
Vaccine: IPV, RAB
Symptoms: Angioedema, Pyrexia, Reaction to previous exposure to any vaccine, Urticaria, Vomiting
Clinical narrative: Initial case was received on 16 August 2010 from a healthcare professional. A 22 year old female patient received on 10 August 2010 an intramuscular injection of IMOVAX Rabies (lot number D1111-1) (pre-exposure series) and a subcutaneous injection of IPOL (lot number E0123-1). The patient reported to the healthcare professional that she "began to break out in large hives" 4-5 hours post vaccinations. The healthcare professional reported "angioedema", but the patient was not seen by a healthcare professional at the time of the hives. The patient got on a flight. She self medicated with BENADRYL 25 mg orally (frequency unknown) and was not evaluated by a physician at any time. The patient reported that 48-72 hours post vaccination she had a low grade fever (no temperature recorded) and vomited once. The patient received 2 previous doses of IMOVAX Rabies (lot number D0792-1) on 19 July 2010 and 27 July 2010 with no reactions. The patient experienced hives post final dose of Japanese encephalitis vaccine in 2007 but none post first 2 doses. Patient did not have an illness at the time of the vaccinations. Concomitant medication included MALARONE. The patient is allergic to BACTRIM and CEFZIL. No other pre-existing medical conditions were reported. At the time of this report the outcome status of the adverse events was not reported.
Age: 0.61
Sex: M
Vaccine: DTAPIPVHIB, HEP, PNC, RV5
Symptoms: Body temperature increased
Clinical narrative: Temp 102 to 104 day after shots.
Age: 18.0
Sex: F
Vaccine: MEN
Symptoms: Abdominal discomfort, Activated partial thromboplastin time, Arthralgia, Biopsy kidney abnormal, Biopsy skin abnormal
Clinical narrative: Initial report was received on 21 August 2010 from a literature citation: A healthy 18-year-old female patient who had not been known to be taking any prescription medications, had received an injection of MENOMUNE A/C/Y/W-1 (lot number, route and site of administration not reported) on 21 August 2003 and ten days later, she developed a rash beginning around her ankles. Over the next week, the rash spread to her legs, thighs, buttocks and arms. A urinalysis confirmed the presence of blood and protein. On 04 September 2003, a skin biopsy was performed with results consistent with HSP (Henoch-Schonlein Purpura). Prednisone 40 mg was prescribed and tapered over three weeks, and rash resolved. On 08 September 2003, the patient began to notice migrating polyarthralgias of the ankles, knees, elbows and wrists. On 16 September 2003, she developed a second similar rash and experienced a few episodes of abdominal discomfort and nausea and one episode of emesis. On 03 October 2003, she was admitted to the hospital for a renal biopsy. On admission, her physical examination results were abnormal. She had pitting edema of the lower extremities which was greater than or equal to 1, and a nonblanching nonpruritic, maculopapular rash on her arms and legs bilaterally. No vesicles or crusting were noted. Laboratory findings upon admission revealed hemoglobin level of 13.0 g/dL, white blood cell count of 14000.4 cells per uL, platelet count of 288000 cells per uL, prothrombin time of 11.7 seconds, an international normalized ratio (INR) of 1.2, partial thromboplastin time of 24 seconds, and a creatinine level of 1.0 mg/dL; a 24-hour urine test revealed protein excretion of nearly 7g. Results from the renal biopsy revealed glomeruli with mild to moderate segmental mesangial proliferative changes, and occasional glomeruli showed segmental endocapillary proliferation. No tubulitis was seen, and there was no interstitial fibrosis or tubular atrophy. Intratubular red blood cell casts were seen. Immunofluorescent studies showed segmental glomerular mesangial staining for C3 (moderate), properdin (trace) and IgA (trace). The biopsy results were considered diagnostic for HSP. Subsequent to the hospitalization, the patient's HSP had gone into remission, but recurred one year later. Two years later, the patient was still receiving low-dose alternate day prednisone. Outcome was not reported. Documents held by sender: None.
Age: 18.0
Sex: F
Vaccine: MEN
Symptoms: Blood creatinine normal, Blood immunoglobulin A, Blood urine present, Complement factor C3, Haemoglobin normal
Clinical narrative: Initial report was received on 21 August 2010 from a literature citation: A healthy 18-year-old female patient who had not been known to be taking any prescription medications, had received an injection of MENOMUNE A/C/Y/W-1 (lot number, route and site of administration not reported) on 21 August 2003 and ten days later, she developed a rash beginning around her ankles. Over the next week, the rash spread to her legs, thighs, buttocks and arms. A urinalysis confirmed the presence of blood and protein. On 04 September 2003, a skin biopsy was performed with results consistent with HSP (Henoch-Schonlein Purpura). Prednisone 40 mg was prescribed and tapered over three weeks, and rash resolved. On 08 September 2003, the patient began to notice migrating polyarthralgias of the ankles, knees, elbows and wrists. On 16 September 2003, she developed a second similar rash and experienced a few episodes of abdominal discomfort and nausea and one episode of emesis. On 03 October 2003, she was admitted to the hospital for a renal biopsy. On admission, her physical examination results were abnormal. She had pitting edema of the lower extremities which was greater than or equal to 1, and a nonblanching nonpruritic, maculopapular rash on her arms and legs bilaterally. No vesicles or crusting were noted. Laboratory findings upon admission revealed hemoglobin level of 13.0 g/dL, white blood cell count of 14000.4 cells per uL, platelet count of 288000 cells per uL, prothrombin time of 11.7 seconds, an international normalized ratio (INR) of 1.2, partial thromboplastin time of 24 seconds, and a creatinine level of 1.0 mg/dL; a 24-hour urine test revealed protein excretion of nearly 7g. Results from the renal biopsy revealed glomeruli with mild to moderate segmental mesangial proliferative changes, and occasional glomeruli showed segmental endocapillary proliferation. No tubulitis was seen, and there was no interstitial fibrosis or tubular atrophy. Intratubular red blood cell casts were seen. Immunofluorescent studies showed segmental glomerular mesangial staining for C3 (moderate), properdin (trace) and IgA (trace). The biopsy results were considered diagnostic for HSP. Subsequent to the hospitalization, the patient's HSP had gone into remission, but recurred one year later. Two years later, the patient was still receiving low-dose alternate day prednisone. Outcome was not reported. Documents held by sender: None.
Age: 18.0
Sex: F
Vaccine: MEN
Symptoms: Henoch-Schonlein purpura, Immunology test, International normalised ratio normal, Nausea, Oedema
Clinical narrative: Initial report was received on 21 August 2010 from a literature citation: A healthy 18-year-old female patient who had not been known to be taking any prescription medications, had received an injection of MENOMUNE A/C/Y/W-1 (lot number, route and site of administration not reported) on 21 August 2003 and ten days later, she developed a rash beginning around her ankles. Over the next week, the rash spread to her legs, thighs, buttocks and arms. A urinalysis confirmed the presence of blood and protein. On 04 September 2003, a skin biopsy was performed with results consistent with HSP (Henoch-Schonlein Purpura). Prednisone 40 mg was prescribed and tapered over three weeks, and rash resolved. On 08 September 2003, the patient began to notice migrating polyarthralgias of the ankles, knees, elbows and wrists. On 16 September 2003, she developed a second similar rash and experienced a few episodes of abdominal discomfort and nausea and one episode of emesis. On 03 October 2003, she was admitted to the hospital for a renal biopsy. On admission, her physical examination results were abnormal. She had pitting edema of the lower extremities which was greater than or equal to 1, and a nonblanching nonpruritic, maculopapular rash on her arms and legs bilaterally. No vesicles or crusting were noted. Laboratory findings upon admission revealed hemoglobin level of 13.0 g/dL, white blood cell count of 14000.4 cells per uL, platelet count of 288000 cells per uL, prothrombin time of 11.7 seconds, an international normalized ratio (INR) of 1.2, partial thromboplastin time of 24 seconds, and a creatinine level of 1.0 mg/dL; a 24-hour urine test revealed protein excretion of nearly 7g. Results from the renal biopsy revealed glomeruli with mild to moderate segmental mesangial proliferative changes, and occasional glomeruli showed segmental endocapillary proliferation. No tubulitis was seen, and there was no interstitial fibrosis or tubular atrophy. Intratubular red blood cell casts were seen. Immunofluorescent studies showed segmental glomerular mesangial staining for C3 (moderate), properdin (trace) and IgA (trace). The biopsy results were considered diagnostic for HSP. Subsequent to the hospitalization, the patient's HSP had gone into remission, but recurred one year later. Two years later, the patient was still receiving low-dose alternate day prednisone. Outcome was not reported. Documents held by sender: None.
Age: 18.0
Sex: F
Vaccine: MEN
Symptoms: Oedema peripheral, Platelet count normal, Protein urine, Prothrombin time normal, Rash
Clinical narrative: Initial report was received on 21 August 2010 from a literature citation: A healthy 18-year-old female patient who had not been known to be taking any prescription medications, had received an injection of MENOMUNE A/C/Y/W-1 (lot number, route and site of administration not reported) on 21 August 2003 and ten days later, she developed a rash beginning around her ankles. Over the next week, the rash spread to her legs, thighs, buttocks and arms. A urinalysis confirmed the presence of blood and protein. On 04 September 2003, a skin biopsy was performed with results consistent with HSP (Henoch-Schonlein Purpura). Prednisone 40 mg was prescribed and tapered over three weeks, and rash resolved. On 08 September 2003, the patient began to notice migrating polyarthralgias of the ankles, knees, elbows and wrists. On 16 September 2003, she developed a second similar rash and experienced a few episodes of abdominal discomfort and nausea and one episode of emesis. On 03 October 2003, she was admitted to the hospital for a renal biopsy. On admission, her physical examination results were abnormal. She had pitting edema of the lower extremities which was greater than or equal to 1, and a nonblanching nonpruritic, maculopapular rash on her arms and legs bilaterally. No vesicles or crusting were noted. Laboratory findings upon admission revealed hemoglobin level of 13.0 g/dL, white blood cell count of 14000.4 cells per uL, platelet count of 288000 cells per uL, prothrombin time of 11.7 seconds, an international normalized ratio (INR) of 1.2, partial thromboplastin time of 24 seconds, and a creatinine level of 1.0 mg/dL; a 24-hour urine test revealed protein excretion of nearly 7g. Results from the renal biopsy revealed glomeruli with mild to moderate segmental mesangial proliferative changes, and occasional glomeruli showed segmental endocapillary proliferation. No tubulitis was seen, and there was no interstitial fibrosis or tubular atrophy. Intratubular red blood cell casts were seen. Immunofluorescent studies showed segmental glomerular mesangial staining for C3 (moderate), properdin (trace) and IgA (trace). The biopsy results were considered diagnostic for HSP. Subsequent to the hospitalization, the patient's HSP had gone into remission, but recurred one year later. Two years later, the patient was still receiving low-dose alternate day prednisone. Outcome was not reported. Documents held by sender: None.
Age: 18.0
Sex: F
Vaccine: MEN
Symptoms: Rash maculo-papular, Renal disorder, Urine analysis abnormal, Vomiting, White blood cell count increased
Clinical narrative: Initial report was received on 21 August 2010 from a literature citation: A healthy 18-year-old female patient who had not been known to be taking any prescription medications, had received an injection of MENOMUNE A/C/Y/W-1 (lot number, route and site of administration not reported) on 21 August 2003 and ten days later, she developed a rash beginning around her ankles. Over the next week, the rash spread to her legs, thighs, buttocks and arms. A urinalysis confirmed the presence of blood and protein. On 04 September 2003, a skin biopsy was performed with results consistent with HSP (Henoch-Schonlein Purpura). Prednisone 40 mg was prescribed and tapered over three weeks, and rash resolved. On 08 September 2003, the patient began to notice migrating polyarthralgias of the ankles, knees, elbows and wrists. On 16 September 2003, she developed a second similar rash and experienced a few episodes of abdominal discomfort and nausea and one episode of emesis. On 03 October 2003, she was admitted to the hospital for a renal biopsy. On admission, her physical examination results were abnormal. She had pitting edema of the lower extremities which was greater than or equal to 1, and a nonblanching nonpruritic, maculopapular rash on her arms and legs bilaterally. No vesicles or crusting were noted. Laboratory findings upon admission revealed hemoglobin level of 13.0 g/dL, white blood cell count of 14000.4 cells per uL, platelet count of 288000 cells per uL, prothrombin time of 11.7 seconds, an international normalized ratio (INR) of 1.2, partial thromboplastin time of 24 seconds, and a creatinine level of 1.0 mg/dL; a 24-hour urine test revealed protein excretion of nearly 7g. Results from the renal biopsy revealed glomeruli with mild to moderate segmental mesangial proliferative changes, and occasional glomeruli showed segmental endocapillary proliferation. No tubulitis was seen, and there was no interstitial fibrosis or tubular atrophy. Intratubular red blood cell casts were seen. Immunofluorescent studies showed segmental glomerular mesangial staining for C3 (moderate), properdin (trace) and IgA (trace). The biopsy results were considered diagnostic for HSP. Subsequent to the hospitalization, the patient's HSP had gone into remission, but recurred one year later. Two years later, the patient was still receiving low-dose alternate day prednisone. Outcome was not reported. Documents held by sender: None.
Sex: U
Vaccine: MNQ
Symptoms: Borrelia test negative, Facial palsy, Guillain-Barre syndrome, Heart rate increased, Muscular weakness
Clinical narrative: Initial report received from a consumer's parent on 26 August 2010. A patient (age and sex not reported), with a medical history of asthma and allergies to peanuts, nuts, and shrimp, received on 08 June 2010 an injection (route and site not reported) of MENACTRA, lot number U3334AA. The patient had no illness at the time of vaccination, no other vaccinations within 4 weeks prior to MENACTRA and had no adverse events following prior vaccinations. The patient developed symptoms which began with a rash and losing weight (greater than 10 pounds). The symptoms progressed to hives, swelling of the jaw, Bell's palsy, and weakness in the right leg. The patient also had an increase in heart rate. The patient was hospitalized more than once due to the symptoms. The patient was tested for Lyme disease times 4 with negative results. The patient was seen by several doctors including infectious disease and a neurologist. The patient was being looked at for Guillain-Barre syndrome (GBS). The outcome was reported as not recovered. Documents held by sender: None.
Sex: U
Vaccine: MNQ
Symptoms: Rash, Swelling face, Urticaria, Weight decreased
Clinical narrative: Initial report received from a consumer's parent on 26 August 2010. A patient (age and sex not reported), with a medical history of asthma and allergies to peanuts, nuts, and shrimp, received on 08 June 2010 an injection (route and site not reported) of MENACTRA, lot number U3334AA. The patient had no illness at the time of vaccination, no other vaccinations within 4 weeks prior to MENACTRA and had no adverse events following prior vaccinations. The patient developed symptoms which began with a rash and losing weight (greater than 10 pounds). The symptoms progressed to hives, swelling of the jaw, Bell's palsy, and weakness in the right leg. The patient also had an increase in heart rate. The patient was hospitalized more than once due to the symptoms. The patient was tested for Lyme disease times 4 with negative results. The patient was seen by several doctors including infectious disease and a neurologist. The patient was being looked at for Guillain-Barre syndrome (GBS). The outcome was reported as not recovered. Documents held by sender: None.
Age: 4.0
Sex: F
Vaccine: MMR
Symptoms: Blood immunoglobulin G, Endometriosis, Hysterectomy, Measles antibody positive, Mumps antibody test negative
Clinical narrative: Information has been received from a medical assistant concerning an approximately 35 year old female patient who on 15-MAY-1979 was vaccinated with a first dose of MMR II. Concomitant therapy included megestrol acetate. Subsequently the patient had negative mumps titer. On an unknown date the patient required a hysterectomy due to endometriosis. It was also reported that the patient was currently taking megestrol acetate, 20 mg, once a day, but not for cancer. The patient sought medical attention by an office visit. At the time of the report, the outcome of the patient was unknown. Follow up information has been received from a medical assistant who reported that the patient had a hysterectomy and was hospitalized in December 2009. Her mumps titer was drawn in August 2009. Her titers for rubella and measles were positive. At the time of the report the patient's outcome was unknown. Additional information has been requested.
Age: 4.0
Sex: F
Vaccine: MMR
Symptoms: Rubella antibody positive
Clinical narrative: Information has been received from a medical assistant concerning an approximately 35 year old female patient who on 15-MAY-1979 was vaccinated with a first dose of MMR II. Concomitant therapy included megestrol acetate. Subsequently the patient had negative mumps titer. On an unknown date the patient required a hysterectomy due to endometriosis. It was also reported that the patient was currently taking megestrol acetate, 20 mg, once a day, but not for cancer. The patient sought medical attention by an office visit. At the time of the report, the outcome of the patient was unknown. Follow up information has been received from a medical assistant who reported that the patient had a hysterectomy and was hospitalized in December 2009. Her mumps titer was drawn in August 2009. Her titers for rubella and measles were positive. At the time of the report the patient's outcome was unknown. Additional information has been requested.
Age: 26.0
Sex: F
Vaccine: HPV4
Symptoms: Abortion spontaneous, Drug exposure during pregnancy, Haemorrhage
Clinical narrative: Information has been received from a 26 year old female for GARDASIL a Pregnancy Registry product, who on 08-JUN-2010 was vaccinated with a first dose of GARDASIL (route and lot number unspecified). On 08-JUL-2010, the patient was vaccinated with a second dose of GARDASIL (route and lot number unspecified). The patient reported that on 06-JUL-2010, she found out she was pregnant. On 08-JUL-2010, the patient had a miscarriage. It was reported that since 11-AUG-2010, she had abnormal bleeding. The consumer stated that she had a period after her miscarriage but since GARDASIL was given it had caused her to have this abnormal bleeding. The patient also stated she had a miscarriage due to GARDASIL. The patient sought medical attention by visiting the hospital office. It was reported she would had an appointment with a physician on 17-AUG-2010. Additional information has been requested.
Age: 18.0
Sex: F
Vaccine: HPV4
Symptoms: Abortion induced, Drug exposure during pregnancy, Vaginitis bacterial
Clinical narrative: Information has been received from a health professional for the Pregnancy Registry for GARDASIL, concerning a 18 year old female with no pertinent medical history and no previous pregnancies who on 24-FEB-2010 was vaccinated with a first dose of GARDASIL (route and lot# not reported). The patient's last menstrual period (LMP) was 10-JAN-2010 and her expected date of delivery was 14-OCT-2010. On 04-MAR-2010 to 11-MAR-2010, the patient was treated with metronidazole for bacterial vaginitis. On 12-MAR-2010, 8 weeks from LMP, the patient had an elective termination. At the time of the report, the patient's outcome was unknown. Upon internal review, elective termination was determined to be an other important medical event. Additional information has been requested.
Age: 19.0
Sex: F
Vaccine: HPV4
Symptoms: Convulsion
Clinical narrative: This report was received from Research Group and was assigned manufacturer report number MD003. A 19 year old female patient approximately 2 years ago, in approximately 2008 was vaccinated with a dose of GARDASIL. Three or four days after receiving the vaccine, the patient experienced seizures and was hospitalized. The action taken regard GARDASIL and the outcome of the patient were not reported. The reporter felt that seizures was related to therapy with GARDASIL. This was originally reported by a family practitioner. Additional information has been requested.
Age: 66.0
Sex: F
Vaccine: PPV
Symptoms: Injected limb mobility decreased, Injection site erythema, Injection site pain
Clinical narrative: Information has been received from a pharmacist concerning a 66 year old female with hypothyroidism and arthralgia and a history of abdominal pain and diverticulitis, and allergic reaction to CIPRO, hydrocodone, guaifenesin, codeine, amoxicillin, who on 22-AUG-2010 was vaccinated with a dose of PNEUMOVAX 23 (667134/0738Z). Concomitant therapy included SYNTHROID, morphine and ZOFRAN. On 23-AUG-2010 it was noticed that there was an area of erythema which was getting bigger around the injection site area. There was pain and tenderness. The area was "palm-sized" now. This was causing difficulty in mobility. There were no labs or diagnostic tests performed. BENADRYL was given. The patient sought unspecified medical attention. The patient had not recovered at time of report. An area of erythema which is getting bigger around the injection site area, pain and tenderness and difficulty in mobility were considered disabling. Additional information has been requested.
Age: 0.3
Sex: F
Vaccine: RV5
Symptoms: Culture stool positive, Diarrhoea, Rotavirus test positive, Vomiting
Clinical narrative: Information has been received from a health professional concerning a 12 week female patient who on an unspecified date was vaccinated with the second dose of ROTATEQ (Lot number not reported). Subsequently after one day of vaccination, the patient experienced vomiting and diarrhea and was taken to hospital. During hospitalization the patient was diagnosed with possible severe combined immunodeficiency and was hospitalized. A stool for rotavirus was positive (unspecified strain). At the time of the report the patient's present status was unknown. The reporter felt that possible severe combined immunodeficiency was related to therapy with ROTATEQ. BACKGROUND: Rotavirus vaccines are the only live vaccines recommended for infants. Postmarketing reports have described severe gastroenteritis with vaccine viral shedding in infants who received rotavirus vaccine and were later diagnosed with SCID. Food and Drug Administration recently approved labeling changes for ROTATEQ and ROTARIX contraindicating administration to individuals with a history of SCID. We queried VAERS to characterize reports of SCID after rotavirus vaccination. METHODS: VAERS inclusion criteria included current licensed rotavirus vaccines, report dates from February 3, 2006 to January 15, 2010, and queries for the MedDRA preferred term "combined immunodeficiency" as well as any text containing the terms, "SCID" or "combined immunodeficiency." RESULTS: We identified nine reports of SCID and rotavirus vaccination in infants between 3 and 9 months of age. All but one case presented with diarrhea among other symptoms. All infants were hospitalized and had workups leading to the SCID diagnosis. Stool rotavirus testing was positive in all cases and the virus was identified as the vaccine strain in six cases. Prolonged viral shedding was documented in five cases. No deaths were reported. CONCLUSION: The aforementioned labeling changes were warranted given the risk posed by live rotavirus vaccine to individuals with SCID, as illustrated by these VAERS cases. Although congenital, SCID was not diagnosed in these infants until after rotavirus vaccination. Earlier identification of SCID (e.g., from expanded newborn screening or heightened clinical vigilance) could prevent inadvertent live rotavirus vaccine administration and also potentially result in earlier life-saving stem cell transplants. No further information is available.
Age: 68.0
Sex: F
Vaccine: PPV, TD
Symptoms: Joint range of motion decreased, Pain
Clinical narrative: PT STATES THAT LATER ON THE SAME DAY SHE WAS HAVING THROBBING PAIN AND LOSS OF FULL ROM IN HER RIGHT ARM.  IBUPROFEN AND ICE WERE NOT EFFECTIVE.  SHE STATES THAT IT FELT BETTER WHEN PLACED IN A SLING.
Age: 29.0
Sex: F
Vaccine: TDAP
Symptoms: Induration, Mass, Pain
Clinical narrative: Pt complains of hardened knot area and soreness worse every day since vaccination.  "I feel like I have a bouncy ball in my arm."  Pt has tried otc, compresses, Tylenol, and muscle relaxers.
Age: 1.0
Sex: F
Vaccine: MMR, VARCEL
Symptoms: Rash generalised, Rash morbilliform
Clinical narrative: MEASLY RASH ALL OVER
Age: 1.39
Sex: M
Vaccine: MMR
Symptoms: Pyrexia, Rash
Clinical narrative: Fever followed by rash
Age: 5.0
Sex: M
Vaccine: DTAPIPV, MMRV
Symptoms: Injection site erythema, Injection site swelling
Clinical narrative: Lt arm red swollen. Looks like a 4 inch x 3 inch blistered area. (Pics taken by school nurse).
Age: 30.0
Sex: F
Vaccine: TDAP
Symptoms: Feeling hot, Injection site pain, Injection site swelling
Clinical narrative: Pain and some swelling in arm at Injection site & feeling feverish.
Sex: M
Vaccine: HEP, MMR
Symptoms: Inappropriate schedule of drug administration
Clinical narrative: Pt. was administered MMR less than 28 days apart. The 2nd MMR was administered 16 days from the 1st.
Age: 1.26
Sex: M
Vaccine: MMR, VARCEL
Symptoms: Pyrexia, Rash
Clinical narrative: Rash and fever 10 days post MMR & VARIVAX.
Age: 20.0
Sex: F
Vaccine: MNQ, TDAP
Symptoms: Syncope
Clinical narrative: 0950 - Administered vaccines. 0955 - Pt. fainted, slid out of chair onto floor with head coming to rest on chair seat. No head trauma or other injuries observed. Ice pack to back of neck and Sprite consumed. Pt. felt "fine" and left clinic at 1025 hrs.
Age: 66.0
Sex: F
Vaccine: VARZOS
Symptoms: Pruritus, Rash macular
Clinical narrative: Patient had spots that started small and turned into big red blotches (started 8/22/10) and were itchy. Started on face and went down torso. Went to doctor and was put on steroid cream.
Age: 1.26
Sex: M
Vaccine: MMR, VARCEL
Symptoms: Pyrexia, Rash
Clinical narrative: Rash & fever 8 days post MMR.
Age: 83.0
Sex: F
Vaccine: FLU3
Symptoms: Chest discomfort, Dyspnoea, Nervousness
Clinical narrative: Pt stated at bed time she started to have some trouble breathing and felt like she had "a rock" on her chest. Stated she feet a little shaky about an hour or so after injection until event occurred.
Age: 1.29
Sex: M
Vaccine: DTAP, MMR, VARCEL
Symptoms: Pallor, Pruritus, Rash macular
Clinical narrative: Erythematous, macular rash, itchy, blanching beginning on trunk &  spreading peripherally. Began at 10 days after MMR vaccine.
Age: 48.0
Sex: F
Vaccine: FLU3
Symptoms: Dizziness, Feeling abnormal, Nausea, Urticaria
Clinical narrative: Patient c/o feeling "sparkly", lightheaded, nausea 5-10 min after receiving flu vaccine. Hives on trunk, neck and lower jaw began 45-60 min. after flu vaccine. Benadryl 25mg  PO given to pt @ 10:00am. Benadryl 25mg PO given @ 10:45am
Age: 60.0
Sex: F
Vaccine: TDAP
Symptoms: Arthralgia, Chills, Headache, Injection site discomfort, Injection site erythema
Clinical narrative: 8/25/10, 8 PM, fever, chills, LUA redness/swelling/discomfort. 8/26/10, 8 AM, fever, nausea, HA, generalized joint discomfort. 8/26/10 Phone notification to Dr. 8/28/10, 10:20 AM seen by Dr.
Age: 60.0
Sex: F
Vaccine: TDAP
Symptoms: Injection site swelling, Nausea, Pyrexia
Clinical narrative: 8/25/10, 8 PM, fever, chills, LUA redness/swelling/discomfort. 8/26/10, 8 AM, fever, nausea, HA, generalized joint discomfort. 8/26/10 Phone notification to Dr. 8/28/10, 10:20 AM seen by Dr.
Age: 11.0
Sex: F
Vaccine: TDAP
Symptoms: Injection site erythema
Clinical narrative: 9 X 8 cm area of erythema to (L) deltoid, no fever, no tenderness.
Age: 0.37
Sex: M
Vaccine: DTAP, HIBV
Symptoms: Auricular swelling, Diarrhoea, Erythema, Swelling, Swelling face
Clinical narrative: Redness and swelling of ears, hives over face and upper body. Vomiting and then diarrhea. Patient sent to ER - given Benadryl with complete resolution. Was able to take bottle of formula before discharge. No problems since.
Age: 0.37
Sex: M
Vaccine: DTAP, HIBV
Symptoms: Urticaria, Vomiting
Clinical narrative: Redness and swelling of ears, hives over face and upper body. Vomiting and then diarrhea. Patient sent to ER - given Benadryl with complete resolution. Was able to take bottle of formula before discharge. No problems since.
Age: 53.0
Sex: F
Vaccine: VARZOS
Symptoms: Inappropriate schedule of drug administration, No adverse event
Clinical narrative: The patient has not experienced any adverse events to date.
Age: 9.0
Sex: F
Vaccine: FLUX
Symptoms: Injected limb mobility decreased, Injection site induration, Injection site mass, Pyrexia
Clinical narrative: FEVER, HARD BUMP ON SITE, COULD NOT LIFT OR MOVE LEFT ARM
Age: 1.04
Sex: M
Vaccine: MMR, PNC13, VARCEL
Symptoms: Convulsion, Pyrexia, Vomiting
Clinical narrative: Child woke with fever 102.6 rectally, vomited, had seizure and taken to ER.
Age: 4.0
Sex: M
Vaccine: DTAP, IPV, MMRV
Symptoms: Chapped lips, Endotracheal intubation, Lip blister, Rash, Skin exfoliation
Clinical narrative: Pt.c/o rash, chapped lips, that developed into blisters, and then skin sloughing.  Went to ER.  DX: Steven-Johnson Disease.  Sent to Burn Unit. Remains intubated presently. Unsure if vaccines are contributory to illness.
Age: 4.0
Sex: M
Vaccine: DTAP, IPV, MMRV
Symptoms: Stevens-Johnson syndrome
Clinical narrative: Pt.c/o rash, chapped lips, that developed into blisters, and then skin sloughing.  Went to ER.  DX: Steven-Johnson Disease.  Sent to Burn Unit. Remains intubated presently. Unsure if vaccines are contributory to illness.
Age: 42.0
Sex: F
Vaccine: DTAP
Symptoms: Headache, Oedema peripheral, Pruritus, Rash erythematous
Clinical narrative: Headache, Arm Swelling, Red Rash on complete upper arm, Severe Itching
Age: 62.0
Sex: F
Vaccine: DTAP
Symptoms: Arthralgia, Chills, Injected limb mobility decreased, Pain in extremity, Pyrexia
Clinical narrative: Fever, involuntary shivers, aching joints, extremely painful arm (difficult to move).
Age: 5.0
Sex: M
Vaccine: DTAP, IPV, MMRV
Symptoms: Pallor, Pruritus, Urticaria, Vomiting
Clinical narrative: Within 5 minutes of receiving MMRV, the patient began vomiting and was pale. In another 2-3 minutes developed hives and diffuse pruritis. No respiratory distress, drooling, or facial swelling. Patient was given 7.5 ML of Benadryl and observed for 25 minutes. The vomiting resolved about 15 minutes prior to discharge. Itching and hives were improving but still present.
Age: 13.0
Sex: U
Vaccine: MNQ, TDAP, VARCEL
Symptoms: Injection site erythema, Injection site swelling
Clinical narrative: (R) arm swelling & redness at injection site 2 days post injection. Mom states size of golf ball. Denies SOB or swelling any other location.
Age: 18.0
Sex: F
Vaccine: MNQ
Symptoms: Dizziness, Injection site erythema, Injection site pain, Nausea, Pruritus
Clinical narrative: 08/19/10 soreness/redness at site with nausea/dizziness until 08/24/10, diffuse urticaria with pruritis to ER.  Tx'd with ALLEGRA, BENADRYL, ZYRTEC, PREDNISONE.
Age: 18.0
Sex: F
Vaccine: MNQ
Symptoms: Urticaria
Clinical narrative: 08/19/10 soreness/redness at site with nausea/dizziness until 08/24/10, diffuse urticaria with pruritis to ER.  Tx'd with ALLEGRA, BENADRYL, ZYRTEC, PREDNISONE.
Age: 22.0
Sex: F
Vaccine: ANTH, HPV4, ANTH, HPV4, ANTH, HPV4
Symptoms: Abortion spontaneous, Drug exposure during pregnancy, Pregnancy test positive
Clinical narrative: LMP: 20 Jul 10, Vaccinated 02 Aug 10. Positive preg test 23 Aug 10. Miscarriage 28 Aug 20.
Age: 22.0
Sex: F
Vaccine: ANTH, HPV4, ANTH, HPV4, ANTH, HPV4
Symptoms: Abortion spontaneous, Drug exposure during pregnancy
Clinical narrative: LMP: 20 Jul 10, Vaccinated 02 Aug 10. Positive preg test 23 Aug 10. Miscarriage 28 Aug 20.
Age: 11.0
Sex: F
Vaccine: TDAP
Symptoms: Bordetella test positive, Pertussis, Polymerase chain reaction
Clinical narrative: Patient contracted pertussis.
Age: 47.0
Sex: F
Vaccine: TDAP
Symptoms: Full blood count, Pain, Pain in extremity, Rash papular, Red blood cell sedimentation rate
Clinical narrative: Pain down (Lt) arm x 4 wks. Aching. Rash/papular over shoulder & upper back.
Age: 0.18
Sex: M
Vaccine: DTAPIPVHIB, HEP, PNC13
Symptoms: C-reactive protein increased, Coronary artery aneurysm, Coronary artery dilatation, Echocardiogram abnormal, Immunoglobulin therapy
Clinical narrative: Kawasaki Disease. Received IVIG. (+) Coronary artery aneurysm. Dx and followed by ID + Cards.
Age: 0.18
Sex: M
Vaccine: DTAPIPVHIB, HEP, PNC13
Symptoms: Kawasaki's disease, White blood cell count increased
Clinical narrative: Kawasaki Disease. Received IVIG. (+) Coronary artery aneurysm. Dx and followed by ID + Cards.
Age: 4.0
Sex: F
Vaccine: DTAP, VARCEL
Symptoms: Injection site swelling
Clinical narrative: (L) arm swelling. No treatment, resolved.
Age: 22.0
Sex: M
Vaccine: SMALL
Symptoms: Rash, Tenderness
Clinical narrative: Rash, tenderness in left arm. Lasting for 5 days.
Age: 67.0
Sex: F
Vaccine: PPV
Symptoms: Erythema, Skin warm
Clinical narrative: 18 x 8 cm area of erythema and increased warmth L shoulder. BENADRYL advised, prednisone 2 tabs qd x 3 days.
Age: 38.0
Sex: F
Vaccine: HEP, PPV
Symptoms: Erythema, Injection site haemorrhage, Injection site pain, Injection site swelling, Pain
Clinical narrative: 8/25/10 PNEUMOVAX given right deltoid. 8/27/10 Pt c/o Rt arm achy - occ. shooting pain Rt upper arm - 1.5 cm x 7 cm, pale pink - slightly raised area ant. arm - Rt axilla - slight pink area - non-raised 2 cm x 3 cm. No warmth at area - slight ecchymosis at injection site.
Age: 38.0
Sex: F
Vaccine: HEP, PPV
Symptoms: Pain in extremity
Clinical narrative: 8/25/10 PNEUMOVAX given right deltoid. 8/27/10 Pt c/o Rt arm achy - occ. shooting pain Rt upper arm - 1.5 cm x 7 cm, pale pink - slightly raised area ant. arm - Rt axilla - slight pink area - non-raised 2 cm x 3 cm. No warmth at area - slight ecchymosis at injection site.
Age: 40.0
Sex: F
Vaccine: VARCEL
Symptoms: Chills, Injection site erythema, Injection site vesicles, Malaise, Pain
Clinical narrative: Pt. presented to clinic Monday 8/30/10 at 0800 with erythema around injection site (est. 60-70mm) and small blisters noted directly over site of injection. Onset 24 hours after inj.: fever, chills, body aches, malaise. Spoke with pt. via telephone 8/31/10. States injection site has improved.
Age: 40.0
Sex: F
Vaccine: VARCEL
Symptoms: Pyrexia
Clinical narrative: Pt. presented to clinic Monday 8/30/10 at 0800 with erythema around injection site (est. 60-70mm) and small blisters noted directly over site of injection. Onset 24 hours after inj.: fever, chills, body aches, malaise. Spoke with pt. via telephone 8/31/10. States injection site has improved.
Age: 0.17
Sex: M
Vaccine: DTAPIPVHIB, PNC, RV1
Symptoms: Apnoea, Staring, Tension
Clinical narrative: Approx. 3-4hrs. after vaccines given, baby had 20-30 seconds of apnea (without cyanosis), then "wide-eyed" expression and body "tensed" briefly. Entire episode lasted perhaps 1-2 minutes baby normal afterwards. Neg. Exam in ER, and in our office the following day.
Age: 63.0
Sex: F
Vaccine: MNQ
Symptoms: No adverse event, Wrong drug administered
Clinical narrative: MENACTRA given instead of pneumonia vaccine. No adverse event.
Age: 73.0
Sex: M
Vaccine: FLU3, PPV
Symptoms: Injection site anaesthesia
Clinical narrative: Patient reported that after PNEUMOVAX vaccine was given, through overnight. He felt numbness, and paralyzed in the morning to the site of injection. Pt was advised to make a visit to ER. Immediately.
Age: 1.68
Sex: F
Vaccine: DTAP, HIBV, PNC13
Symptoms: Rash generalised, Viral rash
Clinical narrative: Rash all over body-developed day after she received DTAP, PREVNAR, HIB.
Age: 0.33
Sex: M
Vaccine: PNC
Symptoms: Injection site erythema, Injection site induration
Clinical narrative: Pt with 2 inch x 2 inch area of erythema & induration (L) thigh where site of injection occurred.
Age: 3.0
Sex: F
Vaccine: VARCEL
Symptoms: Rash
Clinical narrative: Broke out - abd, back, arms, legs.
Age: 2.0
Sex: M
Vaccine: PNC13
Symptoms: Injection site erythema, Injection site pruritus, Injection site swelling
Clinical narrative: Left arm swelling to the wrist red and itchy.
Age: 3.0
Sex: F
Vaccine: PNC
Symptoms: Injection site erythema, Injection site swelling, Injection site warmth
Clinical narrative: 1st noted redness size of nickel around site of injection. No pain or pruritis. Area of redness became larger than an egg & swelling approx. 1/4" depth. Felt hot to touch. Called Dr office & they rec BENADRYL & TYLENOL & ice."Did that for 2 days". 8/23 9:15 redness size quarter.
Age: 51.0
Sex: F
Vaccine: TDAP
Symptoms: Injected limb mobility decreased, Injection site pain
Clinical narrative: Pt developed (R) mid deltoid pain with reduced ability to actively abduct (R) shoulder > 45 degrees the day following the vaccine. Problem persists 3 months later.
Age: 10.0
Sex: F
Vaccine: TDAP, VARCEL
Symptoms: Optic neuritis
Clinical narrative: Pt dx with right optic neuritis 8/27/10. Sx started 8/24/10.
Age: 4.0
Sex: M
Vaccine: DTAP, IPV, MMR, VARCEL
Symptoms: Erythema, Oedema peripheral, Pyrexia
Clinical narrative: Vaccines given at 10:30am 8/27/10 parents noticed erythema on arm and arm was twice the normal size by 8:30 PM 8/27/10. Pt taken to ER given antibiotic injection and antibiotics for home use. Parents state fever was 101.2 - 101.6. ((L) deltoid).
Age: 73.0
Sex: M
Vaccine: VARZOS
Symptoms: Asthenia, Balance disorder, Confusional state, Death, Dyspnoea
Clinical narrative: June 15 and 16 weakness, unsteadiness - June 17 weakness, falling, fever, fast heartbeat, confusion - June 18 same as above and difficulty breathing (on June 18 20:00 AM put in ICU in critical condition).
Age: 73.0
Sex: M
Vaccine: VARZOS
Symptoms: Fall, Heart rate increased, Intensive care, Pyrexia
Clinical narrative: June 15 and 16 weakness, unsteadiness - June 17 weakness, falling, fever, fast heartbeat, confusion - June 18 same as above and difficulty breathing (on June 18 20:00 AM put in ICU in critical condition).
Age: 74.0
Sex: F
Vaccine: TD
Symptoms: Musculoskeletal pain, Pain in extremity, Swelling
Clinical narrative: Two days after received immunization, noticed sl. swelling, achiness. States still has pain in shoulder - radiates down to elbow & hand. (Also was cleaning out basement during this time). 8/31/2010 Patient states cleaning out basement during this timeframe due to flooding. RN advised patient to seek MD appt as possibly not TD as problem. Enc to continue to use heat/ice as needed.
Age: 12.0
Sex: M
Vaccine: MNQ, TDAP
Symptoms: Dizziness, Hyperhidrosis, Nausea
Clinical narrative: Felt faint, nauseated, sweating.
Age: 46.0
Sex: M
Vaccine: MNQ
Symptoms: Fatigue, Headache, Injection site erythema, Injection site swelling, Injection site warmth
Clinical narrative: Initial case received from a consumer, who is also the patient, on 13 August 2010.  The patient also reported similar events in his wife; that information is captured in case number 2010-04382.  A 46-year-old male patient received an intramuscular left deltoid injection of MENACTRA (lot number not reported) on 11 August 2010 for travel purposes.  The patient denied relevant medical history or illness at time of vaccination, and had no known allergies.  One day post-vaccination, on 12 August 2010, the patient complained of a fever, headache, and fatigue.  He also noted redness, swelling, and warmth at the injection site, and complained that his arm was sore.  He was seen by a physician on 14 August 2010 and treated with steroids and antibiotics.  The patient noted that he had missed 3 days of work.  As of 15 August 2010, he reported feeling "better", although his arm was still sore.  Follow-up information was received 31 August 2010 from a health care professional who provided lot numbers for which identified the events experienced by this patient and his wife (captured in case 2010-04382) are in the context of a cluster.  The MENACTRA lot number was U3434AA.  Outcome remained not recovered.  Documents held by sender: none.
Age: 46.0
Sex: M
Vaccine: MNQ
Symptoms: Pain in extremity, Pyrexia
Clinical narrative: Initial case received from a consumer, who is also the patient, on 13 August 2010.  The patient also reported similar events in his wife; that information is captured in case number 2010-04382.  A 46-year-old male patient received an intramuscular left deltoid injection of MENACTRA (lot number not reported) on 11 August 2010 for travel purposes.  The patient denied relevant medical history or illness at time of vaccination, and had no known allergies.  One day post-vaccination, on 12 August 2010, the patient complained of a fever, headache, and fatigue.  He also noted redness, swelling, and warmth at the injection site, and complained that his arm was sore.  He was seen by a physician on 14 August 2010 and treated with steroids and antibiotics.  The patient noted that he had missed 3 days of work.  As of 15 August 2010, he reported feeling "better", although his arm was still sore.  Follow-up information was received 31 August 2010 from a health care professional who provided lot numbers for which identified the events experienced by this patient and his wife (captured in case 2010-04382) are in the context of a cluster.  The MENACTRA lot number was U3434AA.  Outcome remained not recovered.  Documents held by sender: none.