chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Sex: U
Vaccine: HPV4
Symptoms: Inappropriate schedule of drug administration, No adverse event
Clinical narrative: This spontaneous report as received from a Nurse Practitioner (NP) refers to a patient of unknown age and gender. The patient's medical history and concurrent conditions were not provided. On 09-AUG-2012 the patient was vaccinated with the first dose of GARDASIL 0.5 ml, intramuscular. On 16-OCT-2012 the patient was vaccinated with the second dose of GARDASIL and on 16-NOV-2012 with the third dose. The third dose of GARDASIL was administered one month after the second dose. No adverse effects were reported. No further information was provided. Additional information is not expected.
Age: 16.0
Sex: F
Vaccine: HEPA, HPV4, MNQ
Symptoms: Incorrect storage of drug, No adverse event
Clinical narrative: This spontaneous report as received from a certified medical assistant refers to a patient of unknown demographics. On an unknown date, the patient was vaccinated with a dose of improperly stored GARDASIL (Lot number, expiry date, route and dose were not reported) and PEDVAXHIB (Lot number, expiry date, route and dose were not reported. Certified Medical assistant reported that both vaccines were exposed to temperature of 26 F(Fahrenheit)for a total of 135 hours. No adverse effects reported. Follow-up received. Certified Medical assistant stated other 104 children received GARDASIL and other 18 children received PEDVAXHIB. Follow up information has been received from the certified medical assistant regarding a 16 years old, female patient with no pertinent medical history reported. On 21-FEB-2013 the patient was vaccinated with a dose of GARDASIL (lot number and expiration date not reported) (intramuscular on the arm, dose not reported). Concomitant therapies included MENACTRA (lot number and expiration date not reported) (intramuscular on the right arm, dose not reported) and Hepatitis A vaccine (manufacturer unknown) (lot number and expiration date not reported) (intramuscular on the left arm, dose not reported). It was reported that the patient did not seek medical attention. This is one of the several reports from the same source.
Age: 1.0
Sex: U
Vaccine: MMRV, VARCEL
Symptoms: No adverse event, Wrong drug administered
Clinical narrative: This spontaneous report as received from a licensed practical nurse refers to a 12 month old patient. It was reported that on  16-MAY-2013 the patient received (merck) PROQUAD (lot number not provided) and (merck) VARIVAX (lot number not provided) at the same visit instead of M-M-R II (lot number not provided) and (merck) VARIVAX. No product confusion, just medication error. No adverse event reported. It was unspecified if the patient had sought medical attention. Additional information has been requested.
Sex: U
Vaccine: VARZOS
Symptoms: Expired drug administered, No adverse event
Clinical narrative: This spontaneous report as received from a pharmacy technician refers to a patient of unknown age. On 24-MAY-2013 the patient was vaccinated with a dose of 0.5ml ZOSTAVAX (lot # reported as 0169AE and Exp: 06-MAR-2013) SC. The technician reported the patient received a dose of expired ZOSTAVAX during an immunization clinic. She stated that no adverse effects were reported. The patient did not seek medical attention. Additional information has been requested.
Age: 85.0
Sex: M
Vaccine: PPV, VARZOS
Symptoms: Injection site erythema, Injection site oedema, Injection site swelling
Clinical narrative: His (R) upper arm swelled and turned red with dependent edema where he received the pneumococcal vaccine.
Sex: F
Vaccine: HEP
Symptoms: Inappropriate schedule of drug administration, No adverse event
Clinical narrative: This spontaneous report as received from a nurse practitioner refers to a female patient. The patient received a first dose of RECOMBIVAX HB (Lot #, dose and route not reported) "one year ago" and would receive a second dose today. No adverse effects were reported. It was not known if the patient sought medical attention. Additional information has been requested.
Age: 63.0
Sex: F
Vaccine: PPV
Symptoms: Injection site pain, Rash erythematous
Clinical narrative: (+) slightly red/raised rash; (+) tender at injection site. Pt declined appt and insisted she wasn't worried just called office to let us know (patient is a RN). Denied itching, pain, fever, or anaphylactic sx. Advised pt to use ice compresses 3-4 times daily on site and take MOTRIN prn. Pt has emphysema and is on many meds so believes sx related to that. Advised her that it has been documented that 10% have this same reaction to the pneumonia vaccine.
Sex: U
Vaccine: VARCEL
Symptoms: Incorrect storage of drug, No adverse event
Clinical narrative: This spontaneous report as received from a healthcare worker (her position at the office was "Vaccine Supervisor") refers to an unspecified number of patients of unknown age. On an unknown date the patients was vaccinated with improperly stored VARIVAX (Merck) (lot # unspecified). No symptoms reported. Additional information has been requested.
Age: 60.0
Sex: F
Vaccine: VARZOS
Symptoms: Expired drug administered, No adverse event
Clinical narrative: This spontaneous report as received from a physician refers to a patient of unknown age and gender. On 09-MAY-2013 the patient was vaccinated with ZOSTAVAX lot # 672428/1599AA, 0.65 ml, subcutaneous for prophylaxis. The patient was administered an expired dose (expiration date: 13-JAN-2013). No adverse event was reported. The patient sought medical attention by office visit. Additional information has been requested.
Sex: F
Vaccine: VARZOS
Symptoms: Herpes zoster
Clinical narrative: This spontaneous report as received from a physician assistant refers to a female patient of the age to receive the vaccine. In April 2013 the patient was vaccinated with a standard dose of ZOSTAVAX (lot number unspecified) to prevent shingles. In April 2013, the patient developed shingles after received ZOSTAVAX. The outcome of the patient was not reported. Additional information has been requested.
Age: 11.0
Sex: M
Vaccine: TDAP
Symptoms: Inflammation, Injection site erythema, Injection site pruritus, Injection site swelling, Skin warm
Clinical narrative: 2 days after receiving the vaccine pt started complaining of increased redness, swelling and itching around the injection site. Upon inspection, the deltoid muscle was warm to the touch and inflamed. He was given BENADRYL.
Age: 26.0
Sex: F
Vaccine: HPV4
Symptoms: Arthralgia, Blood test, Chills, Computerised tomogram, Depression
Clinical narrative: This spontaneous report as received from a physician refers to a 26 year old female patient with seasonal allergies. On 10-APR-2013 the patient was vaccinated with GARDASIL lot # 0420AE, dose #3 (route and dose not specified). On 11-APR-2013, the patient experienced dizziness, rash all over the body and headaches. About two weeks later, on approximately 25-APR-2013, the patient experienced additional symptoms which included: joint pain, fever and chills. The reporter noted that on approximately 25-APR-2013, the patient was beginning to feel depressed and discouraged by the continuing symptoms. On an unspecified date, a CAT Scan, Spinal Tap, Ultrasound and unspecified bloodwork lab diagnostic tests were performed (results not provided). The patient sought medical attention by a follow up visit with the Doctor. The outcome of the events was reported as not recovered/not resolved. The causal relationship was not provided. Additional information has been requested.
Age: 26.0
Sex: F
Vaccine: HPV4
Symptoms: Dizziness, Headache, Lumbar puncture, Pyrexia, Rash generalised
Clinical narrative: This spontaneous report as received from a physician refers to a 26 year old female patient with seasonal allergies. On 10-APR-2013 the patient was vaccinated with GARDASIL lot # 0420AE, dose #3 (route and dose not specified). On 11-APR-2013, the patient experienced dizziness, rash all over the body and headaches. About two weeks later, on approximately 25-APR-2013, the patient experienced additional symptoms which included: joint pain, fever and chills. The reporter noted that on approximately 25-APR-2013, the patient was beginning to feel depressed and discouraged by the continuing symptoms. On an unspecified date, a CAT Scan, Spinal Tap, Ultrasound and unspecified bloodwork lab diagnostic tests were performed (results not provided). The patient sought medical attention by a follow up visit with the Doctor. The outcome of the events was reported as not recovered/not resolved. The causal relationship was not provided. Additional information has been requested.
Age: 26.0
Sex: F
Vaccine: HPV4
Symptoms: Ultrasound scan
Clinical narrative: This spontaneous report as received from a physician refers to a 26 year old female patient with seasonal allergies. On 10-APR-2013 the patient was vaccinated with GARDASIL lot # 0420AE, dose #3 (route and dose not specified). On 11-APR-2013, the patient experienced dizziness, rash all over the body and headaches. About two weeks later, on approximately 25-APR-2013, the patient experienced additional symptoms which included: joint pain, fever and chills. The reporter noted that on approximately 25-APR-2013, the patient was beginning to feel depressed and discouraged by the continuing symptoms. On an unspecified date, a CAT Scan, Spinal Tap, Ultrasound and unspecified bloodwork lab diagnostic tests were performed (results not provided). The patient sought medical attention by a follow up visit with the Doctor. The outcome of the events was reported as not recovered/not resolved. The causal relationship was not provided. Additional information has been requested.
Age: 4.0
Sex: F
Vaccine: DTPIPV
Symptoms: Decreased eye contact, Staring, Unresponsive to stimuli
Clinical narrative: Staring. No eye contact. Not responding to questions, commands.
Age: 13.0
Sex: F
Vaccine: HPV4
Symptoms: Rash, Skin papilloma
Clinical narrative: One week after vaccine patient developed bumps on / near vaginal area. They were determined to be warts. Patient is not sexually active.
Age: 9.0
Sex: M
Vaccine: TYP
Symptoms: Dizziness
Clinical narrative: Patient felt light headed and dizzy. Patients father lowered patient to the ground. Cold pack applied to neck, feet elevated, and orange juice given to patient. Had patient remain on floor for five minutes. After five minutes, had patient stand slowly. Patient felt better and left without any other incident.
Age: 15.0
Sex: F
Vaccine: HEPA, HPV4, MNQ
Symptoms: Dizziness, Loss of consciousness
Clinical narrative: Patient recieved 3 vaccines-Hep A and Menactra given at the same time-followed by Gardasil.  Patient stated she felt dizzy and then when we went to lay her down from a sitting position she passed out.
Age: 60.0
Sex: M
Vaccine: TDAP, VARZOS
Symptoms: Hypoaesthesia, Oral herpes, Photopsia, Reading disorder, Retinogram
Clinical narrative: Large blurry areas in vision, flashing light on right side, dark tiny dots in center of vision, difficult to read. Cold sores left lip, left upper lip, numbness left face. Treatment wait and observe, symptoms unabated.
Age: 60.0
Sex: M
Vaccine: TDAP, VARZOS
Symptoms: Slit-lamp examination, Vision blurred, Visual impairment
Clinical narrative: Large blurry areas in vision, flashing light on right side, dark tiny dots in center of vision, difficult to read. Cold sores left lip, left upper lip, numbness left face. Treatment wait and observe, symptoms unabated.
Age: 0.16
Sex: F
Vaccine: 6VAX-F
Symptoms: Crying
Clinical narrative: Continuous crying for 6 hrs. It started 1 hr after vaccination was administered.
Age: 33.0
Sex: M
Vaccine: RAB, RAB
Symptoms: Dyskinesia, Erythema, Hypoaesthesia oral, Musculoskeletal stiffness, Palmar erythema
Clinical narrative: Combined doctor an nurse notes:  30 minutes post rabies after already home got numbness of perioral area with nurse noting some decreased movement of mouth.  Tongue numbness.  Red hands (palms) and face and hands  stiff and hard to flex.  Pruritis all over.  Headache.  Bp 118/72 and pulse 100.  As MD observed over 30 minutes no facial movement abnormality.  Tongue movements normal.  Said he felt like he was wheezing but breath sounds equal bilaterally and no wheezes - normal sounding.  Redness and rash which initially was on palms spread to whole body with clear urticaria on upper arms and axilla.  His breathing is fine and non-labored.  We gave Benadryl 50 mg PO and observed.  3:15 had growing skin rash, but no other advancement of s/s noted.  Pt sitting upright, talking with wife and MD.  Per MD order gave Benadryl 25 mg IM.  3:46 - breathing fine - hands less erythematous - urticaria on arms decreasing - "feels fine." breathing fine - lungs clear - RR 20, P 80.  I think fine and can go home - continue Benadryl.   Face now normal color and can make fist. Has option of changing tomrrow to Zyrtec or Claritin - if last > a couple of days may need steroids so let us know.  I wrote them letter for future reference if he ever needs rabies vaccine again.  Also said he should only get it where they had excellent care and set up for severe reaction.  Not sure but if available Imovax might be less likely to cause reaction than Imovax.
Age: 33.0
Sex: M
Vaccine: RAB, RAB
Symptoms: Pruritus generalised, Rash, Rash generalised, Urticaria
Clinical narrative: Combined doctor an nurse notes:  30 minutes post rabies after already home got numbness of perioral area with nurse noting some decreased movement of mouth.  Tongue numbness.  Red hands (palms) and face and hands  stiff and hard to flex.  Pruritis all over.  Headache.  Bp 118/72 and pulse 100.  As MD observed over 30 minutes no facial movement abnormality.  Tongue movements normal.  Said he felt like he was wheezing but breath sounds equal bilaterally and no wheezes - normal sounding.  Redness and rash which initially was on palms spread to whole body with clear urticaria on upper arms and axilla.  His breathing is fine and non-labored.  We gave Benadryl 50 mg PO and observed.  3:15 had growing skin rash, but no other advancement of s/s noted.  Pt sitting upright, talking with wife and MD.  Per MD order gave Benadryl 25 mg IM.  3:46 - breathing fine - hands less erythematous - urticaria on arms decreasing - "feels fine." breathing fine - lungs clear - RR 20, P 80.  I think fine and can go home - continue Benadryl.   Face now normal color and can make fist. Has option of changing tomrrow to Zyrtec or Claritin - if last > a couple of days may need steroids so let us know.  I wrote them letter for future reference if he ever needs rabies vaccine again.  Also said he should only get it where they had excellent care and set up for severe reaction.  Not sure but if available Imovax might be less likely to cause reaction than Imovax.
Age: 33.0
Sex: M
Vaccine: RAB, RAB
Symptoms: Dyskinesia, Erythema, Headache, Hypoaesthesia oral, Hypotension
Clinical narrative: Combined doctor an nurse notes:  30 minutes post rabies after already home got numbness of perioral area with nurse noting some decreased movement of mouth.  Tongue numbness.  Red hands (palms) and face and hands  stiff and hard to flex.  Pruritis all over.  Headache.  Bp 118/72 and pulse 100.  As MD observed over 30 minutes no facial movement abnormality.  Tongue movements normal.  Said he felt like he was wheezing but breath sounds equal bilaterally and no wheezes - normal sounding.  Redness and rash which initially was on palms spread to whole body with clear urticaria on upper arms and axilla.  His breathing is fine and non-labored.  We gave Benadryl 50 mg PO and observed.  3:15 had growing skin rash, but no other advancement of s/s noted.  Pt sitting upright, talking with wife and MD.  Per MD order gave Benadryl 25 mg IM.  3:46 - breathing fine - hands less erythematous - urticaria on arms decreasing - "feels fine." breathing fine - lungs clear - RR 20, P 80.  I think fine and can go home - continue Benadryl.   Face now normal color and can make fist. Has option of changing tomrrow to Zyrtec or Claritin - if last > a couple of days may need steroids so let us know.  I wrote them letter for future reference if he ever needs rabies vaccine again.  Also said he should only get it where they had excellent care and set up for severe reaction.  Not sure but if available Imovax might be less likely to cause reaction than Imovax.
Age: 33.0
Sex: M
Vaccine: RAB, RAB
Symptoms: Mobility decreased, Musculoskeletal stiffness, Palmar erythema, Pruritus generalised, Rash generalised
Clinical narrative: Combined doctor an nurse notes:  30 minutes post rabies after already home got numbness of perioral area with nurse noting some decreased movement of mouth.  Tongue numbness.  Red hands (palms) and face and hands  stiff and hard to flex.  Pruritis all over.  Headache.  Bp 118/72 and pulse 100.  As MD observed over 30 minutes no facial movement abnormality.  Tongue movements normal.  Said he felt like he was wheezing but breath sounds equal bilaterally and no wheezes - normal sounding.  Redness and rash which initially was on palms spread to whole body with clear urticaria on upper arms and axilla.  His breathing is fine and non-labored.  We gave Benadryl 50 mg PO and observed.  3:15 had growing skin rash, but no other advancement of s/s noted.  Pt sitting upright, talking with wife and MD.  Per MD order gave Benadryl 25 mg IM.  3:46 - breathing fine - hands less erythematous - urticaria on arms decreasing - "feels fine." breathing fine - lungs clear - RR 20, P 80.  I think fine and can go home - continue Benadryl.   Face now normal color and can make fist. Has option of changing tomrrow to Zyrtec or Claritin - if last > a couple of days may need steroids so let us know.  I wrote them letter for future reference if he ever needs rabies vaccine again.  Also said he should only get it where they had excellent care and set up for severe reaction.  Not sure but if available Imovax might be less likely to cause reaction than Imovax.
Age: 33.0
Sex: M
Vaccine: RAB, RAB
Symptoms: Urticaria
Clinical narrative: Combined doctor an nurse notes:  30 minutes post rabies after already home got numbness of perioral area with nurse noting some decreased movement of mouth.  Tongue numbness.  Red hands (palms) and face and hands  stiff and hard to flex.  Pruritis all over.  Headache.  Bp 118/72 and pulse 100.  As MD observed over 30 minutes no facial movement abnormality.  Tongue movements normal.  Said he felt like he was wheezing but breath sounds equal bilaterally and no wheezes - normal sounding.  Redness and rash which initially was on palms spread to whole body with clear urticaria on upper arms and axilla.  His breathing is fine and non-labored.  We gave Benadryl 50 mg PO and observed.  3:15 had growing skin rash, but no other advancement of s/s noted.  Pt sitting upright, talking with wife and MD.  Per MD order gave Benadryl 25 mg IM.  3:46 - breathing fine - hands less erythematous - urticaria on arms decreasing - "feels fine." breathing fine - lungs clear - RR 20, P 80.  I think fine and can go home - continue Benadryl.   Face now normal color and can make fist. Has option of changing tomrrow to Zyrtec or Claritin - if last > a couple of days may need steroids so let us know.  I wrote them letter for future reference if he ever needs rabies vaccine again.  Also said he should only get it where they had excellent care and set up for severe reaction.  Not sure but if available Imovax might be less likely to cause reaction than Imovax.
Age: 28.0
Sex: F
Vaccine: FLUX
Symptoms: Injection site pain, Injection site pruritus, Injection site rash
Clinical narrative: I experienced a painful, itchy rash at the injection site (which was apparently a normal reaction), and over the course of a few weeks that rash mostly disappeared but left a 1/4 inch diameter rash that never went away. I still have it as of May 31, 2013. Some days it itches a lot. Others the rash doesn't bother me. But it still has not gone away. I have never had any rash from eating any eggs or other foods or taking any prescription or over the counter drugs.
Age: 60.0
Sex: F
Vaccine: VARZOS
Symptoms: Headache, Injection site pain, Musculoskeletal stiffness
Clinical narrative: I woke early AM with burning and pain in my left upper arm at the injection sight.  Had a significant headache and my neck was still on the right side.  Took Benadryl and 800 MG Ibuprofen.
Age: 5.0
Sex: F
Vaccine: HEPA
Symptoms: Asthenia, Chest pain, Disorientation, Gaze palsy, Pallor
Clinical narrative: Child became weak, her eyes rolled, and she fainted, with mild seizure-like shaking while lying on floor of doctor's office. When she came to, her face was extremely pale and she was disoriented. She kept complaining of her chest hurting hours afterwards.
Age: 5.0
Sex: F
Vaccine: HEPA
Symptoms: Seizure like phenomena, Syncope, Tremor
Clinical narrative: Child became weak, her eyes rolled, and she fainted, with mild seizure-like shaking while lying on floor of doctor's office. When she came to, her face was extremely pale and she was disoriented. She kept complaining of her chest hurting hours afterwards.
Age: 0.51
Sex: F
Vaccine: DPP, DTAPIPVHIB
Symptoms: Asthenia, Irritability, Lethargy, Pyrexia, Vomiting
Clinical narrative: Woke up at 7:00 AM with temp of 100.9, Tylenol was given. By 11:15 temperature was 102.2, Tylenol was given again. Vomited a large amount at approx. 3:00 PM. Temperature stayed at 102 until approx. 5:00 PM when it dropped to 101. Vomited again at 5:30 PM. Temperature was 99 at 6:30 PM, Tylenol given at approx 7:00 PM. Vomited large amount again at 9:30 PM. Fever 98.9 at 9:30 PM. Very little energy to nurse all day, very fussy and lethargic.
Age: 4.0
Sex: M
Vaccine: DTAP, IPV, MMRV
Symptoms: Injection site erythema, Injection site oedema, Injection site rash, Injection site swelling
Clinical narrative: Rash and swelling from upper thigh down to above knee, swelling is not circumferential erythema and edema to (L) thigh.
Age: 1.02
Sex: F
Vaccine: HIBV, MMR, PNC13, VARCEL
Symptoms: Irritability, Pyrexia, Rash maculo-papular
Clinical narrative: Patient developed subcentimeter raised maculopapular lesions on chest, trunk and extremities with fever and irritability post MMR, VZV, Hib, PCV13 injections.
Age: 53.0
Sex: M
Vaccine: MMR
Symptoms: Arthralgia, Hyperhidrosis, Joint swelling, Oropharyngeal pain, Rash erythematous
Clinical narrative: On 5/20/13 in am developed sore throat and diaphoresis and joint pain (Rt) wrist and (Rt) knee with swelling in (rt) knee. Following that he developed itchy red rash beginning on face and upper torso.
Age: 53.0
Sex: M
Vaccine: MMR
Symptoms: Rash pruritic
Clinical narrative: On 5/20/13 in am developed sore throat and diaphoresis and joint pain (Rt) wrist and (Rt) knee with swelling in (rt) knee. Following that he developed itchy red rash beginning on face and upper torso.
Age: 80.0
Sex: F
Vaccine: TDAP, VARZOS, TDAP, VARZOS
Symptoms: Injection site erythema, Injection site pain, Injection site swelling
Clinical narrative: After patient had ADACEL (Tdap) vaccination, she had injection site pain, swelling, erythema (within 2-3 hours) she went to MD office and MD prescribed antibiotic.
Age: 80.0
Sex: F
Vaccine: TDAP, VARZOS, TDAP, VARZOS
Symptoms: Injection site erythema, Injection site pruritus, Injection site swelling, Injection site warmth
Clinical narrative: After patient had ADACEL (Tdap) vaccination, she had injection site pain, swelling, erythema (within 2-3 hours) she went to MD office and MD prescribed antibiotic.
Age: 24.0
Sex: M
Vaccine: MNQ
Symptoms: Pain in extremity
Clinical narrative: Patient got the meningitis shot 04/11/2013, came back after 1 month on 5/14/13 that he has pain on the hand, he was told to take TYLENOL; no other symptoms, advise him to go see doctor but he refused as he has no money to pay for it, asking if pharmacy will cover his expense.
Age: 70.0
Sex: F
Vaccine: VARZOS
Symptoms: Headache, Injection site erythema, Injection site pruritus, Injection site rash
Clinical narrative: Red, itchy rash at site of injection and headache.
Age: 60.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site swelling, Swelling
Clinical narrative: Pt. woke up on 5-9-13 with swelling from injection site to armpit - pt. called MD and took BENADRYL 25mg - prn. Resolved in 5-6 days.
Age: 56.0
Sex: F
Vaccine: VARZOS
Symptoms: Cellulitis, Injection site erythema, Injection site pain, Injection site swelling, Injection site warmth
Clinical narrative: Patient woke up next morning with sore arm at injection site. It started swelling, becoming red and hot throughout the day. She went to urgent care and was diagnosed with cellulitis and given antibiotic cephalexin.
Age: 1.28
Sex: M
Vaccine: DTAP, HIBV, PNC13
Symptoms: Erythema, Oedema peripheral, Rash generalised, Urticaria
Clinical narrative: Per foster mother about 1 1/2 hours after his vaccinations he had a lacy rash over most of his body and a few hives including one on his face and puffy, red feet.
Age: 12.0
Sex: M
Vaccine: HEPA, HPVX, MEN, TDAP, VARCEL
Symptoms: Nodule
Clinical narrative: Pt has lg, egg sized knot on (R) deltoid, knot still there almost 2 mo after vaccines given. Vaccines not given in our office, unable to give vaccine information (site given, mftr, lot #, ect).
Age: 69.0
Sex: F
Vaccine: PPV
Symptoms: Injection site erythema, Injection site pruritus, Injection site rash
Clinical narrative: Rash - pink, itchy at injection site.
Age: 11.0
Sex: F
Vaccine: HPV4, MNQ, TDAP
Symptoms: C-reactive protein normal, Full blood count normal, Headache, Neck pain, Red blood cell sedimentation rate normal
Clinical narrative: 5/24/13 received Tdap, MENACTRA and HPV vaccines. Developed headache 5/26/13 worsening ea day until this am, when headache is less. However also developed (R) posterior neck pain on palpation and w/ROM of head.
Age: 22.0
Sex: M
Vaccine: TDAP
Symptoms: Dizziness, Grunting, Muscle rigidity, Musculoskeletal stiffness, Posture abnormal
Clinical narrative: Administered vaccine to seated client. Five minutes later, he reports "feeling a little dizzy", given juice box to drink. He remained seated, responsive, then two minutes later he grunted as he tilted his head back, fainted and stiffened entire body, shaking slightly. He urinated on self. Nurse held onto his arm while Amonia inhalant crushed under nose. Client then responsive but still dizzy and complaining of stiff neck, arms and legs. Lying down x 30 min, then sitting up, sipping water. Released home, driven by father at 2:30 5/31/13 - left 2 phone messages checking on client.
Age: 22.0
Sex: M
Vaccine: TDAP
Symptoms: Syncope, Tremor, Urinary incontinence
Clinical narrative: Administered vaccine to seated client. Five minutes later, he reports "feeling a little dizzy", given juice box to drink. He remained seated, responsive, then two minutes later he grunted as he tilted his head back, fainted and stiffened entire body, shaking slightly. He urinated on self. Nurse held onto his arm while Amonia inhalant crushed under nose. Client then responsive but still dizzy and complaining of stiff neck, arms and legs. Lying down x 30 min, then sitting up, sipping water. Released home, driven by father at 2:30 5/31/13 - left 2 phone messages checking on client.
Age: 15.0
Sex: M
Vaccine: HPV4, HPV4, HPV4
Symptoms: Dizziness, Immediate post-injection reaction, Loss of consciousness
Clinical narrative: Pt became light-headed and had a few second period of LOC immediately after the shot. Pt regained consciousness few seconds. Pt was seated and safe the whole time. Pt was monitored and observed for 1/2 hr. Pt was well at that point to walk out to car with mother.
Age: 15.0
Sex: M
Vaccine: HPV4, HPV4, HPV4
Symptoms: Dizziness, Immediate post-injection reaction, Loss of consciousness, Syncope
Clinical narrative: Pt became light-headed and had a few second period of LOC immediately after the shot. Pt regained consciousness few seconds. Pt was seated and safe the whole time. Pt was monitored and observed for 1/2 hr. Pt was well at that point to walk out to car with mother.
Age: 15.0
Sex: M
Vaccine: HPV4, HPV4, HPV4
Symptoms: Syncope
Clinical narrative: Pt became light-headed and had a few second period of LOC immediately after the shot. Pt regained consciousness few seconds. Pt was seated and safe the whole time. Pt was monitored and observed for 1/2 hr. Pt was well at that point to walk out to car with mother.
Age: 18.0
Sex: F
Vaccine: TYP, TYP
Symptoms: Dysphagia, Dyspnoea
Clinical narrative: Patient woke up with difficulty breathing after 1st dose. Difficulty swallowing after 2nd pill. Went to ER. Patient has many allergies.
Age: 18.0
Sex: F
Vaccine: TYP, TYP
Symptoms: Abdominal discomfort, Dysphagia, Dyspnoea, Fatigue, Rash
Clinical narrative: Patient woke up with difficulty breathing after 1st dose. Difficulty swallowing after 2nd pill. Went to ER. Patient has many allergies.
Age: 21.0
Sex: M
Vaccine: YF
Symptoms: Dizziness, Fatigue, Headache, Influenza like illness, Pain
Clinical narrative: 2 days s/p vaccination; aching with flu-like sx. 5 days s/p vaccination: fever, blurred vision, dizziness, HA, fatigue.
Age: 21.0
Sex: M
Vaccine: YF
Symptoms: Pyrexia, Vision blurred
Clinical narrative: 2 days s/p vaccination; aching with flu-like sx. 5 days s/p vaccination: fever, blurred vision, dizziness, HA, fatigue.
Age: 2.0
Sex: F
Vaccine: HEPA, VARCEL
Symptoms: Immediate post-injection reaction, Injection site urticaria
Clinical narrative: 2 small (3 mm x 5 mm) hives appeared at injection site immediately after varicella vaccine injection.
Age: 4.0
Sex: F
Vaccine: DTAPIPV, MMR, VARCEL
Symptoms: Oedema peripheral, Rash erythematous, Swelling, Tenderness
Clinical narrative: Prest swelling and erythematous rash about 8 cm in diameter with tenderness to palpation.
Age: 79.0
Sex: F
Vaccine: PPV
Symptoms: Erythema, Induration, Pruritus
Clinical narrative: Erythema and induration from deltoid to antecubital area - itching - no pain.
Age: 62.0
Sex: F
Vaccine: VARZOS
Symptoms: Rash erythematous
Clinical narrative: Pt was vaccinated on 5/18/13. History of RA and on MTX. MTX dosing is 25mg per week. Wt of pt = 170 lbs. During the week of 5/26 the patient saw red bumps (several) near the injection site. As of 5/31 she still has the bumps. The bumps do not hurt or itch.
Age: 82.0
Sex: F
Vaccine: PPV, TDAP
Symptoms: Injection site cellulitis, Injection site erythema, Injection site swelling, Injection site warmth
Clinical narrative: Left deltoid red, swollen, warm to touch Dx Cellulitis. IM ROCEPHIN given.
Age: 13.0
Sex: F
Vaccine: HEPA
Symptoms: Syncope
Clinical narrative: Child fainted for approximately < 10 seconds several minutes after receiving vaccine (she also received TB PPD skin test).
Age: 15.0
Sex: F
Vaccine: VARCEL
Symptoms: Injection site erythema, Injection site swelling
Clinical narrative: Redness and swelling around injection site. Father gave child BENADRYL.
Age: 1.03
Sex: M
Vaccine: MMR, PNC, VARCEL
Symptoms: Dyspnoea, Middle insomnia, Wheezing
Clinical narrative: Pt given 12 mo immunizations 5-29-2013. Pt given MMR, VZV, PREVNAR. Pt woke up around midnight and mom stated he was "wheezing and gasping for air". Mom called nurse help-line and then went to near by ER. Pt was seen, examined and released.
Age: 11.0
Sex: M
Vaccine: MNQ, TDAP
Symptoms: Erythema, Oedema, Pruritus, Tenderness
Clinical narrative: Redness, edema, itching, tenderness 4 cm area
Age: 1.07
Sex: M
Vaccine: HEPA, HIBV, MMRV, PNC13
Symptoms: Erythema, Rash maculo-papular, Skin lesion
Clinical narrative: Marked erythema, macular facial with salmon colored raised maculopapular lesions.
Sex: U
Vaccine: VARZOS
Symptoms: Expired drug administered, No adverse event
Clinical narrative: This spontaneous report as received from a pharmacist refers to a patient of unknown age and gender. On 21-MAY-2013 the patient was vaccinated with an expired dose of ZOSTAVAX (Batch # 671075, lot # and exp date 671075/1197AA, 25-OCT-2012), 0.65 ml (route and indication were not reported). No concomitant medications were reported. No adverse effect reported. Additional information has been requested.
Sex: F
Vaccine: VARZOS
Symptoms: Injection site erythema
Clinical narrative: This spontaneous report as received from a pharmacist refers to a female patient of unknown age allergic to penicillin. On 14-MAY-2013 the patient was vaccinated with ZOSTAVAX lot # H021712, (subcutaneous, dose unknown) for vaccination. Concomitant therapies included acetaminophen, acetaminophen, VICODIN. The pharmacist reported that a patient developed an injection site reaction at the site of ZOSTAVAX vaccination, described as a red area, no rash. The patient sought medical attention (contacted the pharmacist) and received treatment with BENADRYL. No lab diagnostics were performed. The patient hadn't recovered from the event. Additional information is not expected.
Sex: U
Vaccine: RV5
Symptoms: Expired drug administered, No adverse event
Clinical narrative: This spontaneous report as received from a registered nurse refers to a patient of unknown age and gender. On 20-MAY-2013 an expired dose of ROTATEQ (Batch # 670964, lot# and expiration date reported as 1238AA, 01-APR-2013, respectively) (dose and route were not reported) was administered to a patient. No other concomitant medications were reported. No adverse effect reported. Additional information has been requested.
Sex: U
Vaccine: VARCEL
Symptoms: Expired drug administered, No adverse event
Clinical narrative: This spontaneous report was received from a pharmacist refers to a patient of unknown age and gender. On 20-MAY-2013 the patient was vaccinated with a dose of an expired VARIVAX (merck) (Lot # 670247/0573AA, exp 15-APR-2013). No adverse effect reported. Additional information has been requested.
Sex: U
Vaccine: MMRV
Symptoms: Incorrect storage of drug, No adverse event
Clinical narrative: This spontaneous report as received from a Licensed Practical Nurse refers to an unspecified number of patient of unknown age. The nurse reported that the patients might have received PROQUAD (Merck) (lot#H015787, exp 24-FEB-2014) that was exposed to 45F for 3 weeks (504 hours). The temperature excursion had been determined to be unsupported by in-house stability data. There were no adverse symptoms reported. Additional information has been requested.
Age: 14.0
Sex: M
Vaccine: HPV4
Symptoms: Incorrect storage of drug, No adverse event
Clinical narrative: This spontaneous report as received from a certified medical assistant refers to a patient of unknown demographics. On an unknown date, the patient was vaccinated with a dose of improperly stored GARDASIL (Lot number, expiry date, route and dose were not reported). The certified medical assistant reported that the vaccine was exposed to temperature of 26 F(Fahrenheit)for a total of 135 hours. No adverse effects reported. Follow-up received. Certified Medical assistant stated that other 104 children received GARDASIL. Follow up information has been received from the certified medical assistant regarding a 14 years old, male patient with no pertinent medical history reported. On 22-FEB-2013 the patient was vaccinated with GARDASIL (lot number and expiration date not reported) (intramuscular on the left arm, dose not reported). It was reported that the patient did not seek medical attention. This is one of the several reports from the same source. Additional information is not expected.
Age: 12.0
Sex: F
Vaccine: HPV4
Symptoms: Incorrect storage of drug, No adverse event
Clinical narrative: This spontaneous report as received from a certified medical assistant refers to a patient of unknown demographics. On an unknown date, the patient was vaccinated with a dose of improperly stored GARDASIL (Lot number, expiry date, route and dose were not reported). The certified medical assistant reported that the vaccine was exposed to temperature of 26 F(Fahrenheit)for a total of 135 hours. No adverse effects reported. Follow-up received. Certified Medical assistant stated that other 104 children received GARDASIL. Follow up information has been received from the certified medical assistant regarding an 11 years old, female patient with no pertinent medical history reported. On 01-NOV-2012 the patient was vaccinated with the first dose of GARDASIL (lot number and expiration date not reported) (intramuscular on the right arm, dose not reported). On 07-FEB-2013 the patient received the second dose of GARDASIL (lot number and expiration date not reported) (intramuscular on the left arm, dose not reported). It was reported that the patient did not seek medical attention. This is one of the several reports from the same source. Additional information is not expected.
Age: 10.0
Sex: M
Vaccine: HPV4
Symptoms: Incorrect storage of drug, No adverse event
Clinical narrative: This spontaneous report as received from a certified medical assistant refers to a patient of unknown demographics. On an unknown date, the patient was vaccinated with a dose of improperly stored GARDASIL (Lot number, expiry date, route and dose were not reported). The certified medical assistant reported that the vaccine was exposed to temperature of 26 F(Fahrenheit)for a total of 135 hours. No adverse effects reported. Follow-up received. Certified Medical assistant stated that other 104 children received GARDASIL. Follow up information has been received from the certified medical assistant regarding a 10 years old, male patient with no pertinent medical history reported. On 11-SEP-2012 the patient was vaccinated with the first dose of GARDASIL (lot number and expiration date not reported) (intramuscular on the left arm, dose not reported). It was reported that the patient did not seek medical attention. This is one of the several reports from the same source. Additional information is not expected.
Sex: F
Vaccine: VARZOS
Symptoms: Injection site erythema, Injection site pain, Injection site pruritus, Injection site rash, Injection site reaction
Clinical narrative: This spontaneous report as received from a pharmacist refers to a female patient of unknown age. On 27-MAY-2013 the patient was vaccinated with ZOSTAVAX (lot # and expiration date unspecified) (dose, route and anatomical location unspecified). The pharmacist reported that on 28-MAY-2013, the patient experienced swelling, rash and tenderness at the injection site. Also reported that the reaction was red, swollen and pruritic, although the patient is not experiencing pain at the site. She stated that there are two welts aside from the injection site and they look like they could be a bug bites. She stated the redness was approximately 5 inches long. At the time of the report, the patient's outcome was unknown. Additional information has been requested.
Sex: F
Vaccine: VARZOS
Symptoms: Injection site swelling, Urticaria
Clinical narrative: This spontaneous report as received from a pharmacist refers to a female patient of unknown age. On 27-MAY-2013 the patient was vaccinated with ZOSTAVAX (lot # and expiration date unspecified) (dose, route and anatomical location unspecified). The pharmacist reported that on 28-MAY-2013, the patient experienced swelling, rash and tenderness at the injection site. Also reported that the reaction was red, swollen and pruritic, although the patient is not experiencing pain at the site. She stated that there are two welts aside from the injection site and they look like they could be a bug bites. She stated the redness was approximately 5 inches long. At the time of the report, the patient's outcome was unknown. Additional information has been requested.
Age: 11.0
Sex: F
Vaccine: HPV4
Symptoms: Incorrect storage of drug, No adverse event
Clinical narrative: This spontaneous report as received from a medical assistant refers to a patient of unknown demographics. On an unknown date, the patient was vaccinated with a dose of improperly stored GARDASIL (Lot number, expiry date, route and dose were not reported). The medical assistant reported that the vaccine was exposed to temperature of 26 F (Fahrenheit) for a total of 135 hours. No adverse effects reported. Follow-up received. Medical assistant stated that other 104 children received GARDASIL. Follow up information has been received from the medical assistant regarding an 11 years old, female patient with no pertinent medical history reported. On 05-OCT-2012 the patient was vaccinated with GARDASIL (lot number and expiration date not reported) (intramuscular on the left arm, dose not reported). Concomitant medications included Hepatitis A vaccine (manufacturer unknown) administered on 05-OCT-2012 (intramuscular in the right arm, dose not reported). On 19-FEB-2013 the patient received another dose of GARDASIL (lot number and expiration date not reported) (intramuscular on the right arm, dose not reported). It was reported that the patient did not seek medical attention. This is one of the several reports from the same source. Additional information is not expected.
Age: 72.0
Sex: F
Vaccine: VARZOS
Symptoms: Herpes zoster
Clinical narrative: This spontaneous report as received from a consumer refers to herself, a 72 years old female patient. Consumer report no pertinent medical history, drug reactions or allergies. On 21-SEP-2007 the patient was vaccinated with ZOSTAVAX (lot # and exp date 658208/0886U, 02-DEC-2008, respectively) (dose and route reported as 1 vaccine, injection). There were no concomitant medications. Consumer stated that she came down with shingles on 05-APR-2013 after receive ZOSTAVAX on 21-SEP-2007. Consumer stated shingles lasted until 05-MAY-2013. The patient did not received treatment for shingles. No labs or diagnostics studies were performed. Additional information has been requested.
Sex: U
Vaccine: PPV
Symptoms: Incorrect storage of drug, No adverse event
Clinical narrative: This spontaneous report as received from Licensed Practical Nurse refers to a patient of unknown age and gender. On 21-MAY-2013 the patient was vaccinated with PNEUMOVAX23 (lot # exp date: H017759, 04-JUL-2014) (dose, route and indication were not provided), which was exposed to 70 degrees Fahrenheit for a maximum of 63 hours. No concomitant medications were reported. No adverse effect noted. Additional information has been requested.
Sex: M
Vaccine: HPV4
Symptoms: Incorrect storage of drug, No adverse event
Clinical narrative: This spontaneous report as received from a certified medical assistant refers to a patient of unknown demographics. On an unknown date, the patient was vaccinated with a doe of improperly stored GARDASIL (Lot number, expiry date, route and dose were not reported). The certified medical assistant reported that the vaccine was exposed to temperature of 26 F(Fahrenheit)for a total of 135 hours. No adverse effects reported. Follow-up received. Certified Medical assistant stated that other 104 children received GARDASIL. Follow up information has been received from the certified medical assistant regarding an unknown age, male patient with no pertinent medical history reported. This is one of the several reports from the same source. Additional information is not expected.
Age: 0.18
Sex: M
Vaccine: RV5
Symptoms: Diarrhoea
Clinical narrative: This spontaneous report as received from a licensed practical nurse refers to a 2 months old male patient with no pertinent medical history and no drug reactions/allergies who on 30-APR-2013 was vaccinated with dose 1 of ROTATEQ (batch and Lot No. H016249, exp. 27-MAR-2014) 2 ml,, oral. There were no concomitant medications. In approximately May 2013 (reported as "a little more than 48 hours after receiving ROTATEQ") the patient developed diarrhea. The patient did not received any treatment for the event and no lab diagnostics studies were performed. At the time of the report the patient was currently having 4 episodes of diarrhea per day. The patient's outcome was reported as not recovered. Relationship between diarrhea and therapy with ROTATEQ was not reported. Additional information is not expected.
Age: 51.0
Sex: M
Vaccine: VARZOS, VARZOS
Symptoms: Chills, Diarrhoea, Fatigue, Influenza like illness, Injection site erythema
Clinical narrative: Dark redness (roast beef color) and hard swelling at injection site, the evening of the vaccine, and achiness in gland under arm pit and right groin. Woke up the next morning on 05/31/2013 with flu like symptoms, extreme fatigue, achy, pain in gland under left arm pit, and hard quarter sized bump at injection site, diarrhea, then followed by cupped palm sized swelling of the outer upper left arm at the roughly 25 to 26 hour mark, and mild and intermittent chills, followed by intense chills for hours, and low grade fever and body ache. Took Motrin and Benadryl from the late afternoon, which took some of the fatigue and achiness away, but the intense chills lasted till I fell asleep at about 1:00 AM. At 7:00 AM woke with some chills, and the same amount of cup sized swelling around the quarter sized red vaccine site. Diarrhea only lasted for several hours.
Age: 51.0
Sex: M
Vaccine: VARZOS, VARZOS
Symptoms: Injection site induration, Injection site swelling, Lymph node pain, Oedema peripheral, Pain
Clinical narrative: Dark redness (roast beef color) and hard swelling at injection site, the evening of the vaccine, and achiness in gland under arm pit and right groin. Woke up the next morning on 05/31/2013 with flu like symptoms, extreme fatigue, achy, pain in gland under left arm pit, and hard quarter sized bump at injection site, diarrhea, then followed by cupped palm sized swelling of the outer upper left arm at the roughly 25 to 26 hour mark, and mild and intermittent chills, followed by intense chills for hours, and low grade fever and body ache. Took Motrin and Benadryl from the late afternoon, which took some of the fatigue and achiness away, but the intense chills lasted till I fell asleep at about 1:00 AM. At 7:00 AM woke with some chills, and the same amount of cup sized swelling around the quarter sized red vaccine site. Diarrhea only lasted for several hours.
Age: 51.0
Sex: M
Vaccine: VARZOS, VARZOS
Symptoms: Pyrexia
Clinical narrative: Dark redness (roast beef color) and hard swelling at injection site, the evening of the vaccine, and achiness in gland under arm pit and right groin. Woke up the next morning on 05/31/2013 with flu like symptoms, extreme fatigue, achy, pain in gland under left arm pit, and hard quarter sized bump at injection site, diarrhea, then followed by cupped palm sized swelling of the outer upper left arm at the roughly 25 to 26 hour mark, and mild and intermittent chills, followed by intense chills for hours, and low grade fever and body ache. Took Motrin and Benadryl from the late afternoon, which took some of the fatigue and achiness away, but the intense chills lasted till I fell asleep at about 1:00 AM. At 7:00 AM woke with some chills, and the same amount of cup sized swelling around the quarter sized red vaccine site. Diarrhea only lasted for several hours.
Age: 51.0
Sex: M
Vaccine: VARZOS, VARZOS
Symptoms: Injection site erythema, Injection site induration, Injection site pain, Injection site swelling, Lymphadenopathy
Clinical narrative: Dark redness (roast beef color) and hard swelling at injection site, the evening of the vaccine, and achiness in gland under arm pit and right groin. Woke up the next morning on 05/31/2013 with flu like symptoms, extreme fatigue, achy, pain in gland under left arm pit, and hard quarter sized bump at injection site, diarrhea, then followed by cupped palm sized swelling of the outer upper left arm at the roughly 25 to 26 hour mark, and mild and intermittent chills, followed by intense chills for hours, and low grade fever and body ache. Took Motrin and Benadryl from the late afternoon, which took some of the fatigue and achiness away, but the intense chills lasted till I fell asleep at about 1:00 AM. At 7:00 AM woke with some chills, and the same amount of cup sized swelling around the quarter sized red vaccine site. Diarrhea only lasted for several hours.
Age: 65.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site erythema, Injection site pain, Injection site pruritus, Injection site swelling, Pyrexia
Clinical narrative: Redness, soreness, swelling and itching at site of injection.  Low grade fever.  Took Tylenol.
Age: 23.0
Sex: M
Vaccine: TDAP
Symptoms: Injection site erythema, Injection site induration, Injection site swelling
Clinical narrative: Redness, swelling, and hardness at injection site.
Age: 61.0
Sex: F
Vaccine: VARZOS
Symptoms: Chills, Influenza like illness, Malaise, Vomiting
Clinical narrative: Patient experienced flu-like symptoms (vomiting, chills, malaise).