chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 67.0
Sex: M
Vaccine: VARZOS
Symptoms: Electromyogram normal, Nuclear magnetic resonance imaging spinal cord normal, Pain in extremity, Radicular pain, Surgery
Clinical narrative: Information has been received from a physician concerning a 71 year old male patient with coeliac disease, recurring rash and dermatitis herperatormis, who in 2008 was vaccinated with a dose of ZOSTAVAX (Merck), 0.65 ml (route and lot # not reported). It was reported that, in 2008, within a week of the vaccination, the patient started experiencing severe left extremity pain. It was also reported that the patient had been experiencing the pain intermittently since then. The patient stated he had recurring rash and dermatitis herperatormis, which he got because of celiac disease. He was getting this rash before and after the pain started. The patient was put on acyclovir (date and manufacturer not reported) which helped with the pain. His treatment also included dapsone (unspecified). At the time of the report, the patient's outcome was recovering. Follow up information has been received from a physician concerning a 68 year old retired male patient with coeliac disease treated with diet, who on 28-MAY-2008, was vaccinated with a dose of ZOSTAVAX (Merck), 0.65 ml, subcutaneously into left arm (lot # 659614/0161X, expiration date 11-JUL-2009). No immediate local reaction was reported. 1 week later, on 03-JUL-2008, the patient developed severe radicular pain into left arm that required multiple admissions for pain control. No rash or local injection reaction was noted. It was reported that on an unknown date, electromyogram (EMG) and nuclear magnetic resonance imaging (MRI) were performed and showed cervical spine unremarkable. The patient was treated with gabapentin with some relief. In April 2012 the patient had hair up of pain and another physician gave him acyclovir 800 mg four times a day. No rash noted and pain resolved totally in 24 hours. The patient finished 1 week of acyclovir and pain recurred within few days. It was also reported that the patient was placed on low dose (400 mg) of acyclovir daily and pain resolved completely with continuous use. Acyclovir was stopped temporarily in June while having surgery and pain recurred again. Then the patient was back on continuous acyclovir 400 mg daily and felt very comfortable. At the time of the report the patient recovered. Additional information is not expected.
Sex: F
Vaccine: VARCEL
Symptoms: Abortion spontaneous, Maternal exposure during pregnancy, No adverse event
Clinical narrative: Case of misuse received from a physician on 16-MAY-2012, for VARIVAX (Merck), a Pregnancy Registry product. Case medically confirmed. A female adult patient received a dose of VARIVAX (Merck) (batch number, dose and route not reported) on 18-APR-2012 at the beginning of her pregnancy (LMP: 25-MAR-2012, EDD: 30-DEC-2012). Vaccination context: the patient's eldest son had chickenpox. Follow-up information received on 04-Jul-2012: The patient had a medical history of recurrent spontaneous abortions. She had one child. The patient did not undergo prenatal examination. She received the first dose of VARIVAX vaccine via the intramuscular route in the right deltoid. According to the reporter, the patient experienced no adverse reaction post-vaccination. She experienced a spontaneous abortion within 6 and a half weeks of amenorrhoea. Upon medical review the case was upgraded to serious on 04-Jul-2012 due to spontaneous abortion. Other business partner numbers include E2012-03207. Additional information is not expected.
Age: 70.0
Sex: M
Vaccine: PPV
Symptoms: Oxygen saturation decreased
Clinical narrative: This spontaneous report as received from a registered pharmacist refers to a 70 years old male patient with "CHF" (chronic heart failure). The patient was vaccinated IM with dose 1 and dose 2 PNEUMOVAX 23 on 03-JUL-2012 and 05-JUL-2012, respectively. No other co-suspects were reported. No concomitant medications were reported. The pharmacist reported that prior to 03-JUL-2012, the patient had already been admitted to the hospital for CHF, and was still in the hospital. On 05-JUL-2012 the patient was found to have decreased oxygen sats. The patient had not recovered. No treatment information was reported. The relatedness for decreased oxygen sats is unknown for PNEUMOVAX 23. Additional information has been requested.
Age: 1.24
Sex: F
Vaccine: HIBV, MMR, VARCEL
Symptoms: Attention deficit/hyperactivity disorder, Herpes zoster, Rash vesicular
Clinical narrative: On 7/19/02 day after vaccine pt. broke out into a rash that looked like chicken pox. At age 8 pt. was diagnosed with shingles. Was also diagnosed at age 6 with abrasive deficit disorder.
Sex: U
Vaccine: TTOX
Symptoms: Anaphylactic reaction, Throat tightness
Clinical narrative: Initial report was received from a health care professional through another manufacturer on 09 July 2012 (Service Request Number 1-5286072512). A patient (age and gender not reported) had received a tetanus vaccine (manufacturer, lot number, date, site and route of administration not reported) and after the vaccination had an anaphylactic reaction where the patient's throat closed up. No further information was available at the time of the report. The patient's outcome was not reported. Documents held by sender: None.
Sex: M
Vaccine: PER
Symptoms: Bordetella test positive, Cough, Drug ineffective, Pertussis
Clinical narrative: Initial report received on 05 July 2012 from an electronic lay press article. A male patient (age and birth date not reported), who was also a hospital employee, received an injection of PERTUSSIS VACCINE, manufacturer unknown, (lot number, route, site and side were not reported) on an unspecified date. Approximately two weeks prior to 04 July 2012, the patient developed a nasty cough. Approximately one week prior to 04 July 2012, the patient went to clinic and complained of nasty cough. On Monday, 02 July 2012, test results for whooping cough were positive. "He was vaccinated against pertussis, but it wasn't effective." The patient's past medical history, allergies, and concomitant medications were not reported. Treatment for the patient was not reported; however, anyone with direct exposure to the patient was required to be treated with antibiotics. The patient's outcome was not reported. Documents held by sender: None.
Sex: F
Vaccine: TTOX
Symptoms: Anaphylactic reaction
Clinical narrative: Initial report was received from a health care professional through another manufacturer on 09 July 2012 (Service Request Number 1-5286072150). A female patient (age not reported) had received a tetanus vaccine (manufacturer, lot number, date, site and route of administration not reported) and an unspecified amount of time later had an anaphylactic reaction. No further information was available at the time of the report. The patient's outcome was not reported. Documents held by sender: None.
Age: 0.53
Sex: M
Vaccine: DTAPHEPBIP, HIBV, PNC13, RV5
Symptoms: Band neutrophil percentage, Blood culture, Chest X-ray, Differential white blood cell count, Full blood count
Clinical narrative: Fever, irritability within 24 hours of receiving vaccines ER visit 7/8/12 T 103 (R) 1918 pm OTC ADVIL/TYLENOL OV 7/9/12 T 104.5 degrees (R) Increased WBC 20,600 manual diff. Pt. admitted by Dr. 46 Neutrophils 8 Bands 35 lymphocytes 1 monocytes.
Age: 0.53
Sex: M
Vaccine: DTAPHEPBIP, HIBV, PNC13, RV5
Symptoms: Irritability, Lymphocyte percentage, Metabolic function test, Monocyte percentage decreased, Neutrophil percentage decreased
Clinical narrative: Fever, irritability within 24 hours of receiving vaccines ER visit 7/8/12 T 103 (R) 1918 pm OTC ADVIL/TYLENOL OV 7/9/12 T 104.5 degrees (R) Increased WBC 20,600 manual diff. Pt. admitted by Dr. 46 Neutrophils 8 Bands 35 lymphocytes 1 monocytes.
Age: 0.53
Sex: M
Vaccine: DTAPHEPBIP, HIBV, PNC13, RV5
Symptoms: Pyrexia, Urine analysis, White blood cell count increased
Clinical narrative: Fever, irritability within 24 hours of receiving vaccines ER visit 7/8/12 T 103 (R) 1918 pm OTC ADVIL/TYLENOL OV 7/9/12 T 104.5 degrees (R) Increased WBC 20,600 manual diff. Pt. admitted by Dr. 46 Neutrophils 8 Bands 35 lymphocytes 1 monocytes.
Sex: M
Vaccine: HEP
Symptoms: Blood culture negative, Breath holding, Chest X-ray normal, Crying, Cyanosis
Clinical narrative: Crying, gaggy, holding breath, cyanotic.
Sex: M
Vaccine: HEP
Symptoms: Pylorospasm, Retching, X-ray gastrointestinal tract abnormal
Clinical narrative: Crying, gaggy, holding breath, cyanotic.
Age: 19.0
Sex: F
Vaccine: SMALL
Symptoms: Unevaluable event
Clinical narrative: None reported at this time.
Age: 65.0
Sex: F
Vaccine: TD
Symptoms: Erythema, Nodule, Pain, Pruritus, Swelling
Clinical narrative: PAIN AND REDNESS AND A KNOT ABOUT THE SIZE OF A DIME THE FOLLOWING MORNING AFTER THE SHOT. THAT EVENING HAD GROWN HOT, RED, AND INCREASED IN SIZE, THE SIZE OF MY FIST. LOTS OF PAIN AND SWELLING AND SEVERE ITCHING SINCE.
Age: 18.0
Sex: F
Vaccine: MNQ
Symptoms: Body temperature increased, Injection site erythema, Injection site pain, Injection site warmth, Pain
Clinical narrative: Complaining of soreness, redness, and warmth at injection site. On 7/11/12 temperature 100 degrees and aching all over.
Age: 39.0
Sex: F
Vaccine: DTAP
Symptoms: Cough, Dizziness, Hypersensitivity, Nausea, Retching
Clinical narrative: Almost immediately after injection pt felt dizzy and asked for water. Within 10 minutes she developed tightness in her throat when swallowing and developed a cough. Denied SOB. After 20 min she had developed nausea with wretching and was sent to the emergency department.
Age: 39.0
Sex: F
Vaccine: DTAP
Symptoms: Thirst, Throat tightness
Clinical narrative: Almost immediately after injection pt felt dizzy and asked for water. Within 10 minutes she developed tightness in her throat when swallowing and developed a cough. Denied SOB. After 20 min she had developed nausea with wretching and was sent to the emergency department.
Age: 12.0
Sex: F
Vaccine: HEPA, HPV4, MNQ, VARCEL
Symptoms: Erythema, Injection site erythema, Skin warm, Swelling
Clinical narrative: Quarter-sized reddened area on right upper arm.  Large area (greater than hand-sized), red, swollen, and warm to touch.
Age: 14.0
Sex: M
Vaccine: IPV, MNQ, TDAP, VARCEL
Symptoms: Abdominal discomfort, Pyrexia
Clinical narrative: PATIENT AWOKE NEXT MORNING WITH UPSET STOMACH AND FEVER OF 100.6'F.  WAS GIVEN MOTRIN. FEVER CONTINUED ON AND OFF THROUGH THE NEXT DAY AND HALF.
Age: 64.0
Sex: M
Vaccine: VARZOS
Symptoms: Feeling hot, Headache, Pain in extremity, Pyrexia
Clinical narrative: C/O headache, upon arriving home around 3pm went soak in hot tub of water. After getting out and cooling down still felt hot. Fever 102 F. orally. Motrin 800mg po with relief. Slept but awoke w c/o aches in legs and fever returned, 102 orally. This went on for 3 days.
Age: 24.0
Sex: F
Vaccine: RAB
Symptoms: Dizziness, Nausea, Vomiting
Clinical narrative: NAUSEA, VOMITING, AND DIZZINESS. SYMPTOMS SUBSIDED 07/10/2012 @ 8:00 AM.
Age: 88.0
Sex: F
Vaccine: TDAP
Symptoms: Injection site erythema, Injection site pain, Injection site swelling, Injection site warmth
Clinical narrative: Swollen, reddened, tender at and around injection site. Warmth to touch.
Age: 1.05
Sex: F
Vaccine: DTAPIPVHIB, HEP, MMR, VARCEL
Symptoms: Pyrexia, Rash generalised, Rash papular, Rash pruritic
Clinical narrative: Fever for 2 days followed by papular pruritic rash all over body.
Age: 3.0
Sex: F
Vaccine: TYP
Symptoms: Abdominal discomfort, Asthenia, Lethargy, Pyrexia, Vomiting
Clinical narrative: I received a phone call from Mom saying that patient was having stomach upset and feeling weak, lethargic and feverish shortly after she got home from receiving the IM Typhoid vaccine. Her arm site of the injection was not showing signs of cellulitis nor reaction. Also, there were no signs of throat swelling or stridor or wheezing. Mom try to give her some fluids and a popcicle, and patient vomited. I told Mom to give patient Benadryl; and later when I called them about 10PM, patient had fallen asleep.
Age: 76.0
Sex: F
Vaccine: TDAP
Symptoms: Cyst, Injection site erythema, Injection site induration, Injection site mass, Injection site warmth
Clinical narrative: This case is 1 of a cluster of 2 patients' who experienced similar adverse events following vaccination with ADACEL. The event for the second patient was captured in case number 2011-06319. Initial report received from a health care professional on 03 August 2011. A female patient received a left deltoid intramuscular injection (dose 1) of ADACEL, sanofi pasteur Ltd. lot number C3927AA, on an unknown date (reported as one week ago). The patient's medical history was not reported. The patient complained of left deltoid redness and hotness at the injection site and one week later still has hard firm lump at the site. On patient examination, the patient had an induration (described as grape-size cyst) with no signs of inflammation (cold abscess?). On application of warm compresses (no antibiotic were used), the patient reported quick resolution of symptoms. The outcome was reported as recovered. Follow-up information was received from health care professional on 19 September 2011. The patient had received the ADACEL vaccination on 25 July 2011 (previously reported as one week ago). The patient had no illness at the time of vaccination. No further information was available at the time of the report. The patient's outcome remained recovered. Documents held by sender: None.
Age: 4.0
Sex: F
Vaccine: MMR
Symptoms: Local reaction, Pruritus
Clinical narrative: Local reaction adjacent to injection site 2.5 cm x 2.5 cm; pruritic; ibuprofen/BENADRYL.
Age: 0.75
Sex: M
Vaccine: FLUX, PNC13
Symptoms: Agitation, Injection site swelling, Pyrexia
Clinical narrative: Patient developed swelling at site of injection, developed a fever and remained agitated and febrile for several days. 104.2 F rectal temperature noted on 01/07/2011.  Parents administered ibuprofen to lower temperature.  High temperatures abated but fever continued for several days.
Age: 40.0
Sex: F
Vaccine: MMR
Symptoms: Pain, Pyrexia, Rash
Clinical narrative: Fever low grade up to 102F. Generalized body aches and pains. 7/16/12 developed rash and still febrile.
Age: 29.0
Sex: F
Vaccine: TDAP
Symptoms: Activities of daily living impaired, Injection site pain, Muscular weakness, Pain, Pain in extremity
Clinical narrative: Pain and weakness in arm, impedes activities of daily living. Constant ache at injection site and shooting pain from that location with movement.
Age: 22.0
Sex: F
Vaccine: VARCEL
Symptoms: Injection site erythema, Injection site haematoma, Injection site induration, Injection site pain, Injection site swelling
Clinical narrative: Bruising aprox 1 cm immediately surrounding site of injection, then swelling, tenderness, and pink induration approximately 5 cm in diameter.  Raised small wheals surrounding the 1 cm area of the bruise.  She obtained advice of a pharmacist and applied Benadryl which gave minimal relief.  By the time I could observe the site on 7/16/12, the redness, swelling and tenderness had diminished.
Age: 22.0
Sex: F
Vaccine: VARCEL
Symptoms: Injection site urticaria
Clinical narrative: Bruising aprox 1 cm immediately surrounding site of injection, then swelling, tenderness, and pink induration approximately 5 cm in diameter.  Raised small wheals surrounding the 1 cm area of the bruise.  She obtained advice of a pharmacist and applied Benadryl which gave minimal relief.  By the time I could observe the site on 7/16/12, the redness, swelling and tenderness had diminished.
Age: 10.0
Sex: F
Vaccine: VARCEL
Symptoms: Herpes zoster, Injection site reaction
Clinical narrative: Zoster- lesions on L shoulder extending to arm.
Age: 67.0
Sex: M
Vaccine: VARZOS
Symptoms: Herpes zoster
Clinical narrative: Extensive dermatomal shingles outbreak Lt back to umbilical area (T10 distribution).
Age: 60.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site erythema, Injection site nodule, Injection site pain, Injection site pruritus, Injection site swelling
Clinical narrative: No symptoms until 48 hours post injection. Patient presented with redness, swelling, fever, and a knot at injection site. Patient complains of itching and soreness at injection site which have improved over time. Patient spoke with PCP who agreed with our recommendation of a cold compress and antihistamine treatment for symptoms.
Age: 60.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site warmth
Clinical narrative: No symptoms until 48 hours post injection. Patient presented with redness, swelling, fever, and a knot at injection site. Patient complains of itching and soreness at injection site which have improved over time. Patient spoke with PCP who agreed with our recommendation of a cold compress and antihistamine treatment for symptoms.
Age: 69.0
Sex: M
Vaccine: UNK
Symptoms: Pain in extremity, Pelvic pain
Clinical narrative: Lower pelvis pain with radiating pain extending down both legs.
Age: 49.0
Sex: F
Vaccine: FLU3
Symptoms: Arthralgia, Finger deformity, Inflammation, Injection site atrophy, Injection site pain
Clinical narrative: Incredible bilateral finger joint pain which has overshadowed the pain of a FULLY TORN ACETABULAM right hip--hip tear on 3/04/11; this pain in finger joints is deforming, inflammatory and I was even placed on Fentanyl for this increase of pain; a LESION appeared on the top my left hand and it was quickly seen by a dermatologist who not believing my medical HX misdiagnosed it as Eczema; a divit exists in the muscle at injection site, which hurt for over one month and is still tender to the touch.  My rheumatologist is non-interested and claims there is nothing wrong; The medical assistant who gave the injection had been self-touching and I get on him to wash again, change gloves, etc. for the B 12 shots I quit getting there.  My finger pain and deformation were also seen by my hand doctor but this was months ago and the pain and deformity have me wanting hospice, but NO ONE WILL DIAGNOSE THIS!!!!  Also, I had a low-grade fever for 7-8 days.
Age: 49.0
Sex: F
Vaccine: FLU3
Symptoms: Injection site reaction, Joint injury, Pain in extremity, Pyrexia, Skin lesion
Clinical narrative: Incredible bilateral finger joint pain which has overshadowed the pain of a FULLY TORN ACETABULAM right hip--hip tear on 3/04/11; this pain in finger joints is deforming, inflammatory and I was even placed on Fentanyl for this increase of pain; a LESION appeared on the top my left hand and it was quickly seen by a dermatologist who not believing my medical HX misdiagnosed it as Eczema; a divit exists in the muscle at injection site, which hurt for over one month and is still tender to the touch.  My rheumatologist is non-interested and claims there is nothing wrong; The medical assistant who gave the injection had been self-touching and I get on him to wash again, change gloves, etc. for the B 12 shots I quit getting there.  My finger pain and deformation were also seen by my hand doctor but this was months ago and the pain and deformity have me wanting hospice, but NO ONE WILL DIAGNOSE THIS!!!!  Also, I had a low-grade fever for 7-8 days.
Age: 1.1
Sex: F
Vaccine: HEPA, PNC, VARCEL
Symptoms: Pyrexia
Clinical narrative: Fever of 103.9,
Age: 0.17
Sex: F
Vaccine: DTAPIPVHIB, HIBV, PNC, RV5
Symptoms: Incorrect dose administered
Clinical narrative: Patient received 2 doses of Hib on 7/13/12. Pt received PENTACEL plus an extra Hib.
Age: 76.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site erythema, Injection site pruritus, Injection site swelling
Clinical narrative: Pt called 2 days after injection stating she had redness, swelling & itching at injection site.
Age: 46.0
Sex: F
Vaccine: TTOX
Symptoms: Back pain, Electromyogram, Hypoaesthesia, Lumbar puncture, Oedema peripheral
Clinical narrative: Started with severe back pain, swollen feet, numbness on toes for about 2 weeks.
Age: 55.0
Sex: M
Vaccine: VARZOS
Symptoms: Burning sensation, Swelling face, Urticaria
Clinical narrative: Swelling in face, burning welts on abd and face and arms.
Age: 0.3
Sex: M
Vaccine: DTAPIPVHIB, HEP, PNC13
Symptoms: Rash
Clinical narrative: Per mom 6 hours after vaccine had head to toe rash that lasted 2 days.
Age: 1.01
Sex: M
Vaccine: VARCEL
Symptoms: Rash papular, Varicella post vaccine
Clinical narrative: Given varicella vaccine 6/29/2012. Papulovesicular rash eruption 7/6 - 7/7. Evaluated 7/9/12 thought to have systemic varicella. No fever.
Age: 66.0
Sex: F
Vaccine: UNK
Symptoms: Injection site erythema
Clinical narrative: Following day reported to pharmacy with reddened area at injection site. Followed up 2 days later & patient assured me that it was resolving.
Age: 3.0
Sex: F
Vaccine: MMR
Symptoms: Injection site pruritus, Injection site rash
Clinical narrative: Large bumps on site/area of shot (thigh) inner elbows w/bumps too (smaller) itchy.
Age: 5.0
Sex: F
Vaccine: VARCEL
Symptoms: Hypersensitivity, Injection site erythema, Injection site induration, Injection site vesicles, Local reaction
Clinical narrative: Extensive local allergic response with erythema, mild induration, vesicle at site of injection.
Age: 17.0
Sex: F
Vaccine: HPV4, MNQ, TDAP
Symptoms: Dizziness, Fall, Syncope
Clinical narrative: Client received 3 immunizations - Tdap in left deltoid, then MCV4 and HPV4 in right deltoid. Client chatting, then said "I feel faint". She leaned head back, closed eyes then fell forward in faint. Nurse held client up, administered smelling salts and client awoke in about 20 seconds.
Age: 75.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site erythema, Injection site oedema, Injection site pruritus, Injection site rash, Injection site swelling
Clinical narrative: Large red rash on (L) arm at site of injection, diameter 3" to 4" swelling, edema, itching and area "hot" to touch. Treatment 5 dys KEFLEX 250 mg & Methylprednisone tablets 4 mg (Mfr Sanofi 6 dys 21 tablets pack has lasted to date 4 1/2 week & appears to be resolving.
Age: 75.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site warmth
Clinical narrative: Large red rash on (L) arm at site of injection, diameter 3" to 4" swelling, edema, itching and area "hot" to touch. Treatment 5 dys KEFLEX 250 mg & Methylprednisone tablets 4 mg (Mfr Sanofi 6 dys 21 tablets pack has lasted to date 4 1/2 week & appears to be resolving.
Age: 28.0
Sex: F
Vaccine: TDAP
Symptoms: Maternal exposure during pregnancy, Wrong drug administered
Clinical narrative: Pt was pregnant 11.5 weeks and received a Tdap vaccine instead of a f/u injection. The Tdap is recommended for 20 week and over.
Age: 69.0
Sex: F
Vaccine: VARZOS
Symptoms: Dyspnoea, Dyspnoea exertional, Formication, Wheezing
Clinical narrative: On 6-28-12 developed a sensation of a creepy crawly feeling over her head and body. Also noted some dyspnea with exertion and wheezing. Symptoms have persisted although they are better.
Age: 4.0
Sex: M
Vaccine: DTAPIPVHIB, IPV, MMR, VARCEL
Symptoms: Pain in extremity, Pyrexia
Clinical narrative: Child got routine immunizations, Vz, MMR, IPV plus a PENTACEL (instead of Dtap) c/o legs hurting, slight temp. Recovered - no continuing effects.
Age: 18.0
Sex: U
Vaccine: MNQ, VARCEL
Symptoms: Injection site erythema, Injection site swelling, Lip swelling, Oedema peripheral
Clinical narrative: Red, raised, swollen area size of 50 cent piece, on site of injection. Swollen lips, left arm advised ice the swollen area on arm.
Age: 15.0
Sex: F
Vaccine: HEP, HPV4
Symptoms: Bed rest, Dyskinesia, Gaze palsy, Loss of consciousness
Clinical narrative: Pt with LOC with jerky movements of bilateral arms and legs, eyes rolled upward. Regained consciousness in 5-6 seconds. Pt placed at bedrest and monitored for >1hr prior to discharge. No meds given.
Age: 0.18
Sex: F
Vaccine: DTAPIPVHIB, PNC13, RV5
Symptoms: Crying
Clinical narrative: 4 after after receiving vaccine child developed high pitch inconsolable cry.
Age: 11.0
Sex: F
Vaccine: HEPA, HPV4, MNQ, TDAP
Symptoms: Alopecia, Haemoglobin normal, Thyroid function test normal
Clinical narrative: Mother reports daughter began losing hair one week after 1st GARDASIL, accelerated after 2nd GARDASIL. Lost about 1/3 of hair. Took to PP in September 2011. Tested thyroid and for anemia, results negative. Mother reports new hair growth in last few months. Had third HPV administered at PP 1-25-12.
Age: 0.09
Sex: F
Vaccine: HEP
Symptoms: Asthenia, Pallor
Clinical narrative: Patient was very pale and weak within 10 minutes after receiving the first dose of Hep B (GSK) vaccine. She then sleep for a few hours and woke up with better color and strength.
Age: 5.0
Sex: F
Vaccine: MMR, VARCEL
Symptoms: Cellulitis, Injection site erythema, Injection site oedema, Injection site reaction, Injection site vesicles
Clinical narrative: Injection site reaction involving upper arm (left). Multiple blisters formed along with erythema from mid portion of arm to elbow. Edema noted as well. This was the site of varicella vaccine administration. Given cephalexin for cellulitis as treatment.
Age: 55.0
Sex: F
Vaccine: FLU3
Symptoms: Nonspecific reaction
Clinical narrative: Patient states had to be on antibiotics for 6 months.
Age: 2.0
Sex: M
Vaccine: DTAPIPVHIB, VARCEL
Symptoms: Urticaria
Clinical narrative: Patient had PENTACEL & VARIVAX on 7/6/12 patient seen in ER. 7/8/12 - patient had hives on abd., back and face.
Age: 63.0
Sex: F
Vaccine: VARZOS
Symptoms: Hyperaesthesia, Injection site erythema, Injection site induration, Injection site swelling, Injection site warmth
Clinical narrative: Rec'd shot 7/5, 3" red ring around area, dark red around shot entry. Feels like a golf ball inside. Very hard & sensitive to touch. Lots of heat felt also on raised area. Swollen 1 day after shot.
Age: 59.0
Sex: F
Vaccine: VARZOS
Symptoms: Burning sensation, Erythema, Pain in extremity, Pruritus
Clinical narrative: States arm was a bit red & itchy day of injection following AM. Said while upper arm was red & painful and felt like it was on fire for about 1 week. Redness did not subside & 3 weeks. She did not seek medical attention for this.
Age: 1.5
Sex: M
Vaccine: HEPA
Symptoms: Pyrexia
Clinical narrative: Pt developed a fever in the first 24 hrs. after administration on 6/29/12 & fever continued for 5 days (probably not related at all.
Age: 3.0
Sex: F
Vaccine: MMR
Symptoms: Body temperature fluctuation, Convulsion, Tremor, Vomiting
Clinical narrative: Information has been received from a female consumer concerning her approximately 40 month old daughter who in December 2011 (reported as one and a half year ago) was vaccinated with a dose of MMR II, (dose, route and Lot# not reported). In December 2011 (reported also as about a year and a half ago) within about 24 hours of receiving the vaccine the patient experienced uncontrollable shaking, throwing up, seizure, convulsing and fluctuating temperature. The patient went to ER and received unspecified treatment. The patient was not admitted to the (unspecified) hospital. Subsequently in December 2012 (reported also as about a year and a half ago) the patient recovered from uncontrollable shaking, throwing up, seizure and convulsing and fluctuating temperature. Upon internal review, seizure and convulsing were determined to be important medical events. Follow-up information has been received from a registered nurse, who stated she had already reported all the information. No further information is available.
Age: 10.0
Sex: M
Vaccine: HPV4, TDAP, VARCEL
Symptoms: Cough, Lip swelling, Urticaria
Clinical narrative: Lips swelling, cough, hives treatment epinephrine sub q 1:1000 went home stable.
Sex: F
Vaccine: VARZOS
Symptoms: Erythema, Oedema peripheral, Urticaria
Clinical narrative: Erythema, edema to left arm. Whelps throughout body area. Symptoms began morning after injection. (7/12/12) Saw MD on 7/12/12; Symptoms improved - 7/16/12.
Age: 30.0
Sex: M
Vaccine: ANTH
Symptoms: Expired drug administered, No adverse event
Clinical narrative: On 14 Apr 2012 patient received one expired Anthrax shot. Anthrax lot # FAV 294 had expired on 02 Apr 2012. This was patient's 7th Anthrax dose. Patient stated to me on 07/15/12 that he had no adverse reaction to this Anthrax vaccine. A entry of this event was placed in patient's medical record as well as copy of this form.
Age: 1.77
Sex: F
Vaccine: FLU3, HEPA
Symptoms: Hypersensitivity, Rash generalised, Streptococcus test negative, Vaccination complication
Clinical narrative: Mom reports around noon the Sat. after childs vaccinations the child started having pin-prick size bumps all over body. Reports by 4:00 PM there were patches on chest, arm, legs. Reports went to walk in clinic. Reports 20-30 min while being there at clinic they had spread all over body. Mom reports they tested her for strep and it was neg. Reports they gave her BENADRYL and oral steroid. Mom reports took 3d before went completely away. They told her it was prob. allergic reaction to flu shot.
Age: 78.0
Sex: F
Vaccine: TDAP
Symptoms: Respiratory disorder
Clinical narrative: Within 2 days of receiving injection - she developed severe resp. problems resulting in need for antibiotics, PREDNISONE, and increased use of both bronchodilator and steroids. It took 2 1/2 weeks to get back to normal - has pre-existing COPD.
Age: 85.0
Sex: M
Vaccine: VARZOS
Symptoms: Injection site erythema, Injection site mass, Pruritus
Clinical narrative: On 7/11/12, patient noticed "1/2 dime sized" lump at injection site and redness (about half-dollar size). Pt. reported only slight "on and off" itching, but no pain or fever. Pt. states he feels "perfectly fine."
Age: 66.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site erythema, Injection site pain, Injection site reaction, Injection site swelling
Clinical narrative: This spontaneous report as received from a pharmacist refers to a 66 years old female patient with no drug reactions/allergies. The patient was vaccinated with a dose of ZOSTAVAX (Lot#0364, Exp date: 16-MAR-2012) on 09-JUL-2012. No other co-suspects were reported. No concomitant medications were reported. On 11-JUL-2012 the patient developed an injection site reaction after vaccination with ZOSTAVAX. The patient had swelling the size of a baseball and pain at the injection site. The center of the swelling had a 1-2 inch area of redness. The patient sought medical attention by calling the pharmacist. TYLENOL was given as treatment. At the time of reporting, the patient was not recovered. Additional information has been requested.
Age: 86.0
Sex: M
Vaccine: PPV
Symptoms: Injection site joint pain, Injection site pain, Joint range of motion decreased, Mobility decreased, Rash
Clinical narrative: Information has been received from a medical assistant concerning a female patient who on unknown date, was vaccinated with a dose of PNEUMOVAX 23 (dose, route and lot number not reported). It was reported that on unknown date, the patient who received a dose of PNEUMOVAX 23 developed a rash that was so bad she could not even bend her arm. It was reported that the patient sought unspecified medical attention. The patient outcome was unknown at the time of report. This is one of two reports from the same source. Additional information has been requested. Follow-up information was received from a physician refers to a 86 years old male (also reported by medical assistant as female) patient with no illness at time of vaccination, with type 2 diabetes mellitus, atrial flutter, sick sinus syndrome (SSS), CAD (coronary Artery Disease) and PD (Parkinson's disease). The patient was intramuscularly vaccinated at left deltoid with lot # (671401/1158AA) the first dose PNEUMOVAX 23 (dose unspecified) on 11-NOV-2011 (5:34 pm). Concomitant medications included SINEMET, DIGITEK, propafenone hydrochloride, warfarin, atenolol, metformin, lisinopril, NAMENDA and EXELON. On 12-NOV-2011 the patient experienced severe left shoulder pain, he was seen in office in 16-NOV-2011 (reported 16-NOV-2012), no rash (also reported by medical assistant as developed a rash), no swelling, Range of motion was severely limited by pain. No treatment information was reported. The patient had sought medical attention via doctor visit. No relevant diagnostic test and laboratory data was provided. The outcome of severe left shoulder pain was reported as recovered/resolved on 21-NOV-2011 (reported 21-NOV-2012). Additional information was not expected.
Age: 49.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site pain, Rash
Clinical narrative: This spontaneous report as received from a pharmacist refers to a now 49 years old female patient who was allergic to SULFA, erythromycin and latex. The patient had no pertinent medical history. The patient was vaccinated with ZOSTAVAX (lot # 672606/1655AA, expiration date 21-JAN-2013) on 02-JUL-2012. No other co-suspects were reported. No concomitant medications were reported. On 03-JUL-2012 the patient developed pain at the injection site and rash about 2 inches wide under the injection site. The patient had called the pharmacist for medical attention. No laboratory diagnostics studies or treatment were given. The outcome was unknown. Additional information has been requested.
Sex: U
Vaccine: PPV
Symptoms: Injection site reaction
Clinical narrative: This spontaneous report as received from a physician refers to an unspecified number of patients have injection site reactions from PNEUMOVAX 23 (Lot#, dose and route unspecified). The reporter stated in his experience, he has only seen patients have a local injection site reactions if they have been given PNEUMOVAX 23 a dose in the past, and patients do not have this reaction if they have never been given PNEUMOVAX 23. The outcome of these patients were not reported. Attempts are being made to obtain additional identifying information to distinguish the individual patients mentioned in this report. Additional information will be provided if available.
Age: 18.0
Sex: F
Vaccine: HEP
Symptoms: Hepatitis B antibody negative
Clinical narrative: This spontaneous report as received from a registered nurse refers to a currently 18 years old female patient. The patient was vaccinated with three doses of RECOMBIVAX HB (dose, lot number and route not provided) on unspecified dates as a child. No other co-suspects were reported. No concomitant medications were reported. On an unknown date the patient experienced low hepatitis B antibody titers. The patient had sought medical attention via office visit and no treatment was given. The patient performed hepatitis B antibody titers test. The outcome of low hepatitis B antibody titers was reported as not recovered/not resolved. Additional information is not expected.
Age: 66.0
Sex: F
Vaccine: PPV
Symptoms: Joint swelling, Mobility decreased, Musculoskeletal stiffness
Clinical narrative: This spontaneous report as received from a 66 year old female consumer with no pertinent medical history and no drug reaction or allergies. The patient was vaccinated with a 0.5 ml dose of PNEUMOVAX 23 (Lot# and route not reported) on 09-JUL-2012. No other co-suspects were reported. Concomitant medications included metoprolol and XANAX. Within hours of getting the shot, on 09-JUL-2012 the patient experienced swelling in the joint of shoulder in the right arm. She had no redness at the injection site but had been unable to move her right arm for the last 3 days. She said her "arm was locked up." She had talked to her physician twice and was told to take some ibuprofen and soak her arm in magnesium sulfate and apply ice to the area. No lab diagnostics studies were performed. At the time of this report the patient had not recovered. Additional information has been requested.
Sex: U
Vaccine: VARZOS
Symptoms: Pain, Rash
Clinical narrative: Information has been received from a nurse practitioner concerning two patients who on unspecified dates were vaccinated with ZOSTAVAX (Merck) (lot# not reported). The nurse practitioner was told by one of her patients that patient's two friends came down with painful rash after receiving ZOSTAVAX (Merck). The nurse practitioner did not know if rash appeared around injection site or other parts of the body. At the time of the report, the patients' outcome was unknown. All telephone attempts to obtain follow-up information have been unsuccessful. Additional information has been requested.
Sex: F
Vaccine: HPV4
Symptoms: Abdominal pain
Clinical narrative: This spontaneous report was received from a registered nurse refers to a female patient of unknown age. The patient was vaccinated with GARDASIL (lot number unknown). No other co-suspects were reported. No concomitant medications were reported. On an unknown date the patient experienced severe abdominal pain. Calcium carbonate (TUMS) was given as treatment for the event. It was unspecified if the patient had sought medical attention. The outcome was reported as recovered at an unknown date. This is one of several reports received from the same reporter. Additional information has been requested.
Age: 66.0
Sex: M
Vaccine: VARZOS
Symptoms: Blindness, Herpes zoster ophthalmic, Necrotising retinitis, Retinal detachment, Retinitis viral
Clinical narrative: Information has been received from a physician concerning a 71 year old male patient with no pertinent medical history who on 05-JUL-2007 was vaccinated with a dose of ZOSTAVAX (Merck) (lot# 658081/0743U; exp. 08-NOV-2008), 0.65ml. The physician mentioned that in March-2012 the patient had been diagnosed with acute retinal necrosis, which was later deemed to be zoster retinitis. This AE started in his right eye, then spread to his left eye, and his retina had since detached in his right eye. On approximately 22-JUN-2012 (reported as "now") the patient had some vision loss, but the doctor did not specify the extent of the loss. The patient went to the ER visit at an unspecified hospital for treatment and was given oral valacyclovir hydrochloride, prednisone and intraocular ganciclovir. The patient sought unspecified medical attention. The AE improved after stopping therapy. Therapy was not reintroduced. At the time of the report, the patient was recovering. Additional information was received from the registered nurse who indicated that the physisican has no further information to provide. Additional information is not expected.
Age: 17.0
Sex: M
Vaccine: HPV4
Symptoms: Abdominal distension, Abdominal pain, Diarrhoea, Rash, Rash generalised
Clinical narrative: Information has been received from a physician concerning a 17 year old male patient who on an unspecified date was vaccinated with an unspecified 0.5mL dose of GARDASIL. It was reported that the patient experienced a diffuse rash in the morning after receiving GARDASIL. The patient sought medical attention by calling the physician. It was reported BENADRYL was given as treatment for the adverse event. On an unspecified date, the patient recovered from diffuse rash. Follow-up information received from the physician revealed that the patient was a 17 year old male with no pre-existing allergies, birth defects or medical conditions and no history of adverse events following prior vaccination and no illness noted at the time of vaccination who on 23-MAY-2012 was vaccinated IM with the second 0.5 mL dose of GARDASIL in his left arm (lot # 672721/0101AE, expiration date 10-OCT-2014). No illness at time of vaccination was noted. On 04-MAY-2012 the patient experienced abdominal pain and bloating, generalized rash and diarrhea. No laboratory tests/diagnostics studies were performed. At the time of reporting, the patient's outcome was unknown. Additional information has been requested.
Age: 60.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site erythema, Injection site reaction, Urticaria
Clinical narrative: Information has been received from a 60 year old female patient with penicillin and SERZONE allergy and no other pertinent medical history who on 06-JUN-2012 was vaccinated SC with a dose of ZOSTAVAX (Merck), 0.65ml. On 07-JUN-2012 the patient mentioned that she had a red welt on her right arm at the injection site that was the size of a quarter. The patient was also questioning the fact that after she picked up the vaccine from her pharmacy, more that 30 minutes had elapsed before the shot was given to her. Her pharmacy said that it was okay to give her the vaccine up to 60 minutes after reconstitution. The product was not refrigerated the time of pickup at the pharmacy and the time of the injection at the doctor's office. There was no lab diagnostic performed. The patient had not sought medical attention and there was no treatment given to her. At the time of the report, the patient was not recovered. Follow up information has been received from the Medical Assistant (MA) concerning the 60 year old female patient with allergy to CARBOCAINE, Guaifenesin and ENTEX LA, penicillin, SERZONE and TEQUIN and no illness at time of vaccination, who on 06-JUN-2012 at 16:20 was vaccinated SQ into the right upper arm with the first dose of ZOSTAVAX (Merck) (lot number 672932/0599AE; exp. 22-JUN-2013), 0.5ml (previously reported as 0.65 ml). The M.A. reported that the patient was given ZOSTAVADX (Merck) without incident. There were no adverse reactions to vaccine or side effects reported by the patient (previously reported as red welt on her right arm at the injection site that was the size of a quarter). The M.A. also stated that the patient picked up the medication from the pharmacy at 15:45. The vaccination appointment was scheduled for 16:00. The patient was taken back at 16:08 p.m., was very argumentative, stated she was informed per pharmacy that needed to have the vaccine given within 30 min. Patient was informed she was still within the acceptable amount of time per physician. Additional information is not expected.
Age: 15.0
Sex: M
Vaccine: HEP
Symptoms: Hepatitis B surface antibody negative
Clinical narrative: Information has been received from a registered nurse concerning a 15 year old male patient with no pertinent medical history and no drug reaction/allergies who on 14-JUL-2001, was vaccinated with the first dose of hepatitis B virus vaccine rHBsAg (manufacturer unknown, could not be ruled out) (lot# not reported). On 31-AUG-2001, the patient was vaccinated with the second dose of hepatitis B virus vaccine rHBsAg (lot# not reported) and on 22-JAN-2002, was vaccinated with the third dose of hepatitis B virus vaccine rHBsAg (lot# not reported). The nurse reported that the patient's titer was too low. The patient received 3 doses at another provider's office. At the time of the report, the patient's outcome was unknown. The patient sought medical attention. Follow-up information has been received from a medical assistant who stated she would need to retrieve the patient's chart from storage and then forward the chart and WAES letter to the physician if provided her the patient's birth date. Follow-up information received from the physician revealed that the patient did not received hepatitis B virus vaccine rHBsAg (manufacturer unknown) in their office. Additional information is not expected.
Age: 19.0
Sex: F
Vaccine: HPV4
Symptoms: Inappropriate schedule of drug administration, No adverse event
Clinical narrative: This spontaneous report as received from a physician referred to a 19 years old female patient. The patient was vaccinated with doses 1,2, and 3 GARDASIL on 10-APR-2007, on 05-AUG-2008 and on 18-JUN-2012, respectively. No adverse experience has been observed or reported. No treatment information was reported. Additional information has been requested.
Sex: F
Vaccine: HPV4
Symptoms: Unevaluable event
Clinical narrative: This spontaneous report as received from a nurse practitioner referred to a female patient of unknown age. The patient was vaccinated with dose 1 of GARDASIL on 10-JAN-2010. The patient was vaccinated with dose 2 GARDASIL on 16-FEB-2010. No other co-suspects were reported. No concomitant medications were reported. The patient was now in the office to received dose 3. No symptoms were reported. No treatment information was reported. Additional information has been requested.
Sex: U
Vaccine: HPV4
Symptoms: Inappropriate schedule of drug administration, No adverse event
Clinical narrative: This spontaneous report as received from a physician assistant referred to a currently 29 year old patient. The patient was vaccinated with dose 1 GARDASIL, about 3 years ago, in 2009, when she was 26 years old. No other co-suspects were reported. No concomitant medications were reported. On 10-JUL-2012 the patient went in to the physician's office to possibly complete the GARDASIL series. The patient is now 29 years old. No adverse effects were reported. No treatment information was reported. Additional information has been requested.
Sex: U
Vaccine: PPV
Symptoms: Incorrect storage of drug, No adverse event
Clinical narrative: Information has been received from a healthcare worker (immunization official) concerning an unknown number of patients who on unspecified dates, might have been vaccinated with PNEUMOVAX 23 (lot number, dose and route not reported) that was improperly stored. The healthcare worker called for a stability check for the vaccines that were exposed to 16.2 C for 9 hours. At the time of the report no adverse events were reported. This is one of several reports received from the same source. All telephone attempts to obtain follow up information have been unsuccessful. Additional information has been requested.
Age: 60.0
Sex: M
Vaccine: PPV
Symptoms: Injection site erythema, Injection site pain, Injection site swelling, Injection site warmth
Clinical narrative: Information has been received from a registered nurse concerning a 60 year old male patient with drug reactions or allergies to morphine, penicillin and tetanus who on 11-JUN-2012, was vaccinated with a dose of PNEUMOVAX 23 vaccine, 0.5 mL, subcutaneously (lot number 672962/0025AE, expiration date 11-OCT-2013). There was no concomitant medication. On 12-JUN-2012, the patient developed redness and swelling at the injection site after receiving PNEUMOVAX 23 vaccine. BENADRYL was given as a treatment for redness and swelling at the injection site. At the time of report the patient's outcome was recovering. No laboratory tests were performed. The patient sought unspecified medical attention, contacted office. This is one of several reports received from the same source. A lot check has been initiated. A standard lot check investigation has been finalized. All in-process quality checks for the lot number 672962/0025AE in question were satisfactory. The lot met the requirements of the agency and was released. Follow up information was received from a registered nurse concerning the 60 years old retired male patient with hypertension, hyperlipedemia, allergies to "MS" morphine sulphate, penicillin and tetanus, history of ulcer and no illness at time of vaccination, who on 11-JUN-2012 at 15:26 p.m was vaccinated subcutaneously in his left arm with the first dose of PNEUMOVAX 23 (Lot# 672962/0025AE, Exp. Date: 18-OCT-2013) at private doctor's office/hospital with private funds. No other co-suspects were reported. No concomitant medications were reported. It was reported that on 11-JUN-2012 (previously reported as 12-JUN-2012) at 17:00 p.m the patient began to get redness, swelling and heat at injection site and pain area. Symptoms increased by 12-JUN-2012 and on 15-JUN-2012, the patient recovered. The patient did not seek medical attention. The relatedness for redness at the injection site, pain area, heat at injection site and swelling at the injection site was unknown for PNEUMOVAX 23. Additional information is not expected.