chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 66.0
Sex: F
Vaccine: VARZOS
Symptoms: Headache, Incision site pain, Malaise, Oropharyngeal pain, Pneumonia
Clinical narrative: Very fatigued on 6/14/2012 and 6/15/2012, Dizzy and re-injured joints and one year old incision, were hurting on 06/16/2012, Dizzy and sinus drainage on 06/17/2012, Headache on 06/18/2012, Sore throat on 06/19/2012, Headache and cough wheezing on 06/20/2012 (went to Multi Care Doctor, my doctor was on vacation, Dr said there was a nasty cold going around and prescribed 500MG Amoxicillin daily and told me to take Advil, by 7AM 06/21/2012 I was so sick and dehydrated my husband took me to Hospital, I was diagnosed with pneumonia, was given Levaquin intravenously and four tablets, 750MG each daily at home, and an Albuterol inhaler.
Age: 66.0
Sex: F
Vaccine: VARZOS
Symptoms: Sinus operation, Wheezing
Clinical narrative: Very fatigued on 6/14/2012 and 6/15/2012, Dizzy and re-injured joints and one year old incision, were hurting on 06/16/2012, Dizzy and sinus drainage on 06/17/2012, Headache on 06/18/2012, Sore throat on 06/19/2012, Headache and cough wheezing on 06/20/2012 (went to Multi Care Doctor, my doctor was on vacation, Dr said there was a nasty cold going around and prescribed 500MG Amoxicillin daily and told me to take Advil, by 7AM 06/21/2012 I was so sick and dehydrated my husband took me to Hospital, I was diagnosed with pneumonia, was given Levaquin intravenously and four tablets, 750MG each daily at home, and an Albuterol inhaler.
Age: 12.0
Sex: F
Vaccine: HPV4, MNQ, TDAP
Symptoms: Erythema, Pyrexia, Skin turgor decreased, Tenderness
Clinical narrative: Fever, turgor, erythema, and tenderness. Rx: BACTRIM 200/40/5mL, Triamcinolone topical 0.1%; ORAPRED 15 mg/5mL, MOTRIN.
Age: 41.0
Sex: F
Vaccine: HEP, MMR
Symptoms: Dizziness
Clinical narrative: Given MMR dose at 0827 at 0832 pt c/o of lightheadedness/dizziness. Pt hx of Autoimmune anaphylaxis.
Age: 16.0
Sex: F
Vaccine: HEPA, HPV4, MNQ
Symptoms: Gaze palsy, Musculoskeletal stiffness, Tremor
Clinical narrative: Injections given, first Hep A, then HPV, in left arm, then MENACTRA given in right arm. Went to dispose of syringe and get Depo when patient started laying back on table, then started shaking, arms, stiffened, eyes rolled back slightly. Stood next to patient to prevent falling. Called for help. Lasted approx 15 seconds.
Age: 13.0
Sex: F
Vaccine: HPV4, MNQ, TDAP
Symptoms: Headache, Rash generalised
Clinical narrative: Pt stated she developed light headache about 1 hr after getting vaccines lasting about 1 hr. next day rash developed on arms around 10am. & started spreading to rest of body. By 5pm had rash all over body & was taken to the ER. pt was examine & given BENADRYL to take until rash cleared. No other tests done.
Age: 63.0
Sex: M
Vaccine: VARZOS
Symptoms: Herpes zoster, Rash
Clinical narrative: Shingle rash.
Age: 14.0
Sex: F
Vaccine: HEP, HEPA, IPV, MMR, MNQ, TDAP, VARCEL
Symptoms: Altered state of consciousness, Malaise, Pallor
Clinical narrative: Following vaccine administration, client became pale and when asked if she felt okay, replied "No". Appeared as though she was about to lose consciousness. Assisted to lie down by RN, legs elevated, cool pack placed to posterior neck area. Color better. Answered questions appropriately. Assisted to sip on apple juice. Remained in supine position for approximateley 8 to 10 minutes. Assisted to sit, stand, and transferred to chair. Alert and Oriented x3. Sipping on remainder of apple juice. Observed while sitting in chair for approximately 5 min. Assisted to stand and walk a short distance. Denies dizziness or nausea.
Age: 73.0
Sex: F
Vaccine: TDAP, VARZOS
Symptoms: Injection site erythema, International normalised ratio
Clinical narrative: Localized redness 3 inches below injection site in circular pattern. Patient denies soreness, itching, irritation at affected area. She went for a routine blood draw for INR monitoring and MD prescribed dicloxacillin for possible cellulitis. We will f/u with patient in a few days to track progress.
Age: 57.0
Sex: F
Vaccine: VARZOS
Symptoms: Erythema, Injection site pain, Injection site swelling, Injection site vesicles, Pruritus
Clinical narrative: 7/11/12 Mild swelling, redness, itching & rash. 7/12/12 increased swelling, raised area at site, pt states she went to doctor and received steroid shot prescription for SEPTRA DS. 7/13/12 -  Blisters now present at injection site, burning.
Age: 57.0
Sex: F
Vaccine: VARZOS
Symptoms: Rash, Swelling
Clinical narrative: 7/11/12 Mild swelling, redness, itching & rash. 7/12/12 increased swelling, raised area at site, pt states she went to doctor and received steroid shot prescription for SEPTRA DS. 7/13/12 -  Blisters now present at injection site, burning.
Age: 21.0
Sex: F
Vaccine: HEP, TDAP
Symptoms: Incorrect dose administered
Clinical narrative: Client received a 2nd dose of Tdap on 7-13-12; client had received first dose from another doctor's office but did not provide documentation or report (when asked) that she had received a previous dose; client provided documentation after receiving immunizations that noted a Tdap on 01-09-2012.
Age: 45.0
Sex: F
Vaccine: HEPA
Symptoms: CSF glucose normal, CSF protein decreased, CSF white blood cell count increased, Computerised tomogram normal, Flavivirus test positive
Clinical narrative: Severe fever, HA, stiff neck but no alteration of consciousness or other sx or signs of encephalitis. HA described as "worse ever". CT scan - normal. Rapid recovery. CSF WBC = 608 glu = 64 prot = 12.5.
Age: 45.0
Sex: F
Vaccine: HEPA
Symptoms: Headache, Musculoskeletal stiffness, Polymerase chain reaction, Pyrexia
Clinical narrative: Severe fever, HA, stiff neck but no alteration of consciousness or other sx or signs of encephalitis. HA described as "worse ever". CT scan - normal. Rapid recovery. CSF WBC = 608 glu = 64 prot = 12.5.
Age: 46.0
Sex: F
Vaccine: RAB
Symptoms: Injected limb mobility decreased, Injection site pain, Pain, Pain in extremity
Clinical narrative: Client states she received her third and final Rabies PEP vaccine on June 21, 2012 after which she described the following events.  Client states she selected her left arm for administration of all three doses because she is a right handed person.  States following shot one and two of the series, she had general soreness, but with the third shot the soreness was increased.  States she felt the vaccine/medication enter her muscle during the administration phase, as well as feeling pain in her arm during administration, which was different from the previous two vaccines.  She explained that in the evening of June 21, her left arm became very painful with excruciating pain, along with the inability to lift it up or over her head.  By the next day, June 22, she states it was "bearable" but the pain remained and lasted through the weekend, she was able to lift the arm but had trouble with forward motion.  Denies any redness, warmth, or swelling.  By Saturday, July 21, her arm had begun to feel better, and she did light exercises that weekend; by Monday tripled her normal exercise routine, and quadrupled her stretching.  States her arm is beginning to feel better, but plans to give her doctor a call to discuss.
Age: 0.28
Sex: M
Vaccine: HIBV, PNC13
Symptoms: Crying, Decreased eye contact, Dyskinesia, Injection site erythema, Injection site mass
Clinical narrative: PREVNAR 13 - Right leg small red area at vaccine site, raised lump, high pitched cry, jerking right leg, loss of usual eye contact off and in x few days.
Age: 0.28
Sex: M
Vaccine: HIBV, PNC13
Symptoms: Injection site reaction
Clinical narrative: PREVNAR 13 - Right leg small red area at vaccine site, raised lump, high pitched cry, jerking right leg, loss of usual eye contact off and in x few days.
Age: 0.2
Sex: F
Vaccine: DTAPIPVHIB, PNC, RV5
Symptoms: Apnoea, Irritability
Clinical narrative: Irritability, apnea.
Age: 11.0
Sex: M
Vaccine: HPV4, MNQ, TDAP, VARCEL
Symptoms: Head injury, Skull X-ray normal, Syncope, Tonic clonic movements
Clinical narrative: Syncopal episode with minor tonic-clonic movements 3 min after injection. Pt hit R temple on the ground. Pt was kept at facilty with an ice pack and evaluated/monitored by physician.
Age: 0.34
Sex: M
Vaccine: DTAP, HIBV, IPV, PPV, RVX
Symptoms: Crying, Decreased appetite, Fatigue, Irritability, Pyrexia
Clinical narrative: He got the immunizations at 10:00 AM. He seemed ok, just really tired. He took a nap until 12:00, then he woke up and nursed. He seemed fine (happy and playing). He laid down for his second nap at 1:30 PM. He woke up from his nap at 4:00 PM really fussy, crying, not nursing well, and with a fever of 101. So, I gave him Tylenol. I gave him Tylenol again at 9:00 pm. At 4:00 AM he woke up with a fever of 103. I gave him Tylenol. He got Tylenol again at 8:00 AM and 1:00 PM. Temperature is still 101 with the Tylenol. He nursing better, but still fussy. I called the doctors office to let them know about his fever.
Age: 31.0
Sex: M
Vaccine: ANTH
Symptoms: Convulsion, Encephalitis, Laboratory test, Mental status changes, Pyrexia
Clinical narrative: Pt presented to facility with fever, altered mental status, and seizures. Was diagnosed with meningoencephalitis. An exhaustive evaluation was done to determine the etiology of the meningoencephalitis without any clear cause. The only significant events include an antecedant upper respiratory infection prior to hospitalization and the anthrax vaccine 2 months before. He was dicharged to a rehabiliation facility a following a 1 month hospital stay.
Age: 6.0
Sex: M
Vaccine: DTAP, HEP, HEPA, IPV, DTAPHEPBIP, HEPA
Symptoms: Injection site erythema, Injection site swelling, Injection site warmth
Clinical narrative: Left deltoid area red, swollen, warmer than normal to touch. No fever. Mother had given a foreign medication, that she stated was similar to Tylenol, and applied a cold compress.
Age: 6.0
Sex: M
Vaccine: DTAP, HEP, HEPA, IPV, DTAPHEPBIP, HEPA
Symptoms: Discomfort, Injection site erythema, Injection site induration, Injection site swelling, Injection site warmth
Clinical narrative: Left deltoid area red, swollen, warmer than normal to touch. No fever. Mother had given a foreign medication, that she stated was similar to Tylenol, and applied a cold compress.
Age: 6.0
Sex: M
Vaccine: DTAP, HEP, HEPA, IPV, DTAPHEPBIP, HEPA
Symptoms: Injection site erythema, Injection site swelling, Injection site warmth
Clinical narrative: Upper left arm has a large hard red warm swelling. No fever or other symptons but a little uncomfortable. Advised to give ibuprofen and to observe any changes. Also to report the reaction to the DTaP.
Age: 6.0
Sex: M
Vaccine: DTAP, HEP, HEPA, IPV, DTAPHEPBIP, HEPA
Symptoms: Discomfort, Injection site erythema, Injection site induration, Injection site swelling, Injection site warmth
Clinical narrative: Upper left arm has a large hard red warm swelling. No fever or other symptons but a little uncomfortable. Advised to give ibuprofen and to observe any changes. Also to report the reaction to the DTaP.
Age: 70.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site erythema, Injection site swelling
Clinical narrative: Redness & some swelling around injection site on left arm.  Redness was about 4 inches in diameter.  Patients primary care doctor prescribed a 7 day course of cephalexin therapy.
Age: 65.0
Sex: F
Vaccine: VARZOS, VARZOS
Symptoms: Injection site erythema, Injection site induration, Injection site pain, Injection site pruritus, Injection site urticaria
Clinical narrative: Redness and firmness around injection site (size of 2 half dollar coins), redness spreading towards elbow, slightly itches, warm and painful to touch.
Age: 65.0
Sex: F
Vaccine: VARZOS, VARZOS
Symptoms: Injection site warmth
Clinical narrative: Redness and firmness around injection site (size of 2 half dollar coins), redness spreading towards elbow, slightly itches, warm and painful to touch.
Age: 65.0
Sex: F
Vaccine: VARZOS, VARZOS
Symptoms: Injection site erythema, Injection site induration, Injection site pain, Injection site pruritus, Injection site warmth
Clinical narrative: Redness and firmness around injection site (size of 2 half dollar coins), redness spreading towards elbow, slightly itches, warm and painful to touch.
Age: 28.0
Sex: F
Vaccine: TTOX
Symptoms: Diarrhoea, Fatigue, Hyperaesthesia, Injection site erythema, Injection site swelling
Clinical narrative: Injection site and surrounding 4 inches are hot to the touch, swollen, red, skin/muscles are hardened and sensitive to the touch. Symptoms are still persisting 5 days later but are decreasing. Severe exhaustion, mild nausea and persistent diarrhea. Advil and other pain relievers did nothing to help.
Age: 28.0
Sex: F
Vaccine: TTOX
Symptoms: Injection site warmth, Myosclerosis, Nausea, Skin induration
Clinical narrative: Injection site and surrounding 4 inches are hot to the touch, swollen, red, skin/muscles are hardened and sensitive to the touch. Symptoms are still persisting 5 days later but are decreasing. Severe exhaustion, mild nausea and persistent diarrhea. Advil and other pain relievers did nothing to help.
Age: 39.0
Sex: F
Vaccine: TDAP
Symptoms: Erythema, Oedema peripheral, Pain in extremity
Clinical narrative: Patient woke up the morning after injection with redness, swelling and pain in left arm that radiated up to neck.  Saw private MD 4 days after injection and he gave her a Rx for Keflex TID.
Age: 12.0
Sex: M
Vaccine: MNQ, TDAP
Symptoms: Dizziness, Vomiting
Clinical narrative: Child felt dizzy at time of vaccine. Mom and child walked to car. When they were a few blocks from our office mother called and stated child had vomited X1.
Age: 18.0
Sex: F
Vaccine: MNQ, TDAP
Symptoms: Hyperhidrosis, Pallor
Clinical narrative: Was sitting on exam table. Medical Asst. noticed child looked white and sweaty. Laid patient down on exam table. Patient recovered fully after a few minutes.
Age: 18.0
Sex: F
Vaccine: HPV4, MNQ, TDAP
Symptoms: Pallor, Vision blurred
Clinical narrative: Was sitting on exam table when Medical Asst. noticed her eyes looked unfocused and her face became pale. Did not lose consciousness. Medical Asst. laid patient down on exam table, and recovered after just a few minutes.
Age: 0.18
Sex: M
Vaccine: DTAPIPVHIB, HEP, PNC13, RV5
Symptoms: Erythema
Clinical narrative: Flat erythema on face and abdomen.  No hives.  No SOB, wheezing, or itching.  Patient did not seem bothered.
Age: 62.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site erythema, Injection site rash
Clinical narrative: LARGE RED RASH AROUND INJECTION SITE.
Age: 61.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site rash, Injection site warmth
Clinical narrative: Rash about 3 inches in diameter around injection site. No pain or itching reported. Area was warm to the touch.
Age: 24.0
Sex: F
Vaccine: HEP, MMR, VARCEL
Symptoms: Erythema, Pruritus, Swelling
Clinical narrative: Patient c/o raised, itchy red area the size of 1/2 dollar. Vaccine given 7/12/12. Patient called Health Dept at 11:45 on 7/13/12. Told patient to use cool compress and try to see her MD or if starts feeling worse to go to ER. On (R) arm.
Age: 63.0
Sex: F
Vaccine: VARZOS
Symptoms: Body temperature increased, Headache, Nausea, Rash, Rash erythematous
Clinical narrative: Received vaccine on 07-10-12, temp 99.9 on 07-12-12, nausea, headache, itchy red rash on chest, back, forehead, patient seen here in office on today 7-13-12.
Age: 63.0
Sex: F
Vaccine: VARZOS
Symptoms: Rash pruritic
Clinical narrative: Received vaccine on 07-10-12, temp 99.9 on 07-12-12, nausea, headache, itchy red rash on chest, back, forehead, patient seen here in office on today 7-13-12.
Age: 0.23
Sex: F
Vaccine: DTAPIPVHIB, MMR, VARCEL
Symptoms: Blister, Rash vesicular
Clinical narrative: Varicella date; given on 6/22/12. Date = 7/3/12 vesicles/varicella-like lesions appeared.
Age: 62.0
Sex: U
Vaccine: VARZOS
Symptoms: Dizziness, Erythema, Mass, Pruritus, Skin infection
Clinical narrative: Patient became lightheaded soon afterwards. Experienced large red lump with itchiness. Saw MD at urgent care the following day.
Age: 5.0
Sex: M
Vaccine: DTAP, IPV, MMR, VARCEL
Symptoms: Erythema, Injection site pain, Skin warm, Urticaria
Clinical narrative: Pt had red raised welt 8 cm x 4 1/2 cm hot to the touch. (Sensitive) to left arm.
Age: 2.0
Sex: F
Vaccine: PNC
Symptoms: Irritability, Local reaction, Skin warm
Clinical narrative: Local reaction to PCV 13 (L) deltoid E 60 x 60 mm. I 30 x 35 mm. Tactile temperature. Irritable.
Age: 4.0
Sex: F
Vaccine: DTAPIPV, MMR, VARCEL
Symptoms: Pyrexia, Vomiting
Clinical narrative: Fever 100-101, vomiting starting approximately 12 hours after vaccines, vomiting lasted approx. 12 hours no treatment other than oral rehydration and TYLENOL/MOTRIN was needed.
Age: 55.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site erythema, Vaccination site swelling
Clinical narrative: Pt received vaccine on 7/10/12. On 7/11/12 pt noticed that her arm was a little red and swollen; localized to the site vaccine was given. On 7/13/12 she came to the pharmacy to get a second opinion and report it to us. Pt mentions that it has gotten better every day. She was recommended to put cold compresses and see a doctor if it gets worse.
Age: 70.0
Sex: F
Vaccine: VARZOS
Symptoms: Headache, Injection site erythema, Injection site pruritus, Injection site swelling
Clinical narrative: Redness, swelling at site, pt developed headache several hrs post inj. Seemed to subside as of 7/13/12, itching at site.
Age: 66.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site discolouration, Injection site reaction, Rash erythematous
Clinical narrative: This spontaneous report as received from a registered pharmacist refers to a 65 years old female patient with no drug reactions or allergies. The patient was vaccinated with a dose of ZOSTAVAX (lot # 672607/1716AA expiration date 02-FEB-2013) on 23-JUN-2012. No other co-suspects were reported. No concomitant medications were reported. The pharmacist reported that on 24-JUN-2012, the patient developed a red rash at the injection site. The patient also developed black colored rash above the injection site. The patient saw the pharmacist. The patient did not revealed treatment for the adverse event. There were no Lab diagnosis or studies performed. At the time of the report, the patient had not recovered. The relatedness for red rash at the injection site was unknown for ZOSTAVAX. Additional information has been requested.
Age: 36.0
Sex: F
Vaccine: TDAP
Symptoms: Mass, Pain in extremity
Clinical narrative: Sore arm, small lump at lymph node area on the same arm the shot was administered. By 8:00 PM on 07/12/2012 the lump swelled big enough to cause alarm. Followed up with regular doctor and he said to watch it and take Motrin. If pain gets worse and still persistent by Monday to come back in to doctors office.
Age: 0.27
Sex: M
Vaccine: DTP, MMR
Symptoms: Death, Pulse absent, Pyrexia, Respiratory arrest, Respiratory tract congestion
Clinical narrative: On 05/07/1990 patient went to the Doctor and had a physical, which the doctor said he was in good health and doing well for his age and he also received 2 vaccinations MMR and DPT. He was congested and had a fever after receiving his shots. I gave him infant Tylenol during the day and before I put him to sleep. At 7am approximately 12 hours later I found patient in his bed not breathing and without a pulse. I performed CPR but patient died. The coroner determined that the cause of death was SIDS.
Age: 0.27
Sex: M
Vaccine: DTP, MMR
Symptoms: Resuscitation, Sudden infant death syndrome
Clinical narrative: On 05/07/1990 patient went to the Doctor and had a physical, which the doctor said he was in good health and doing well for his age and he also received 2 vaccinations MMR and DPT. He was congested and had a fever after receiving his shots. I gave him infant Tylenol during the day and before I put him to sleep. At 7am approximately 12 hours later I found patient in his bed not breathing and without a pulse. I performed CPR but patient died. The coroner determined that the cause of death was SIDS.
Age: 65.0
Sex: F
Vaccine: PPV
Symptoms: Erythema, Injection site pain, Pain of skin, Rash macular, Urticaria
Clinical narrative: Tenderness at injection site (expected). Blotchy red welts (hives?) and extremely tender underarm later that evening. Took 2 Aleve tablets at 2:00am. Reported reaction to doctors office on Wednesday. They advised to continue with Aleve and also take Benadryl for redness. Pain subsiding and redness going away by Wednesday (7-11-12)pm. Doctors office called to check with me on Thursday, very concerned. All ok by Friday am (7-13-12).
Age: 44.0
Sex: M
Vaccine: VARZOS
Symptoms: Convulsion
Clinical narrative: Patient reported that he had 4 seizures after receiving the vaccine.  The first was at approximately 12:30 then another about 15 minutes later.  There was one more that evening and another the next day.
Age: 23.0
Sex: M
Vaccine: HEPAB
Symptoms: Dyspnoea, Feeling abnormal
Clinical narrative: Pt reported to Medical facility at approximately 3:30 PM stating he felt like he was developing hives and becoming harder to breathe. Nurse in Charge of Immunizations, Medical Director, and the Nursing Services Superintendant evaluated patient. MD cofirmed patient was experiencing a reaction of some type, ordered treatment with a emergency Epi-Pen. Patients symptoms began improving immediately after Epi-Pen administration. MD ordered patient to be transported to local ER, accompanied by NREMT and an additional Epi-Pen to be evaluated and monitored. Patient stated that he had eaten lunch after receiving vaccination and prior to onset of symptoms.
Age: 5.0
Sex: F
Vaccine: DTAP, IPV, MMRV
Symptoms: Diarrhoea, Lethargy, Nausea, Pyrexia, Vomiting
Clinical narrative: 102 degree fever started.  Fever continued on 7/13/2012 along with nausea, lethargy, and vomiting.  Fever peaked at 103 degrees.  Diarrhea on 7/14/2012 in evening.  Contacted doctor on 7/13/2012 and told to continue administering Tylenol.
Age: 21.0
Sex: F
Vaccine: DTAP
Symptoms: Injection site pain, Lymphadenopathy
Clinical narrative: Swollen glands under arm, proceeded to swell through 7/14 down arm further to side around the serratus anterior; also pain at injection site.
Age: 0.67
Sex: F
Vaccine: DTAPIPVHIB, HEP, PNC13, RV5
Symptoms: Pyrexia
Clinical narrative: Developed fever Tmax 102.8 6 hours after receiving vaccines.
Age: 67.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site erythema, Injection site pain, Injection site swelling
Clinical narrative: Injection site reaction (redness, swelling, pain).
Age: 4.0
Sex: M
Vaccine: DTAPIPV, MMR, VARCEL, DTAPIPV, VARCEL, DTAPIPV, VARCEL
Symptoms: Injection site cellulitis
Clinical narrative: Cellulitis of left thigh.
Age: 4.0
Sex: M
Vaccine: DTAPIPV, MMR, VARCEL, DTAPIPV, VARCEL, DTAPIPV, VARCEL
Symptoms: Drug administered at inappropriate site, Hypersensitivity, Injection site cellulitis
Clinical narrative: Cellulitis of left thigh.
Age: 4.0
Sex: M
Vaccine: DTAPIPV, MMR, VARCEL, DTAPIPV, VARCEL, DTAPIPV, VARCEL
Symptoms: Drug administered at inappropriate site, Injection site cellulitis
Clinical narrative: Cellulitis of left thigh.
Age: 4.0
Sex: M
Vaccine: DTAPIPV, MMR, VARCEL
Symptoms: Injection site cellulitis
Clinical narrative: Cellulitis of left thigh.
Age: 2.0
Sex: M
Vaccine: HEPA, PNC
Symptoms: Injection site erythema
Clinical narrative: Given PREVNAR (L) anterior thigh marked erythema thigh warm 8 cm diameter erythema.
Sex: M
Vaccine: VARZOS
Symptoms: Injection site pain
Clinical narrative: This spontaneous report as received from licensed practical nurse refers to her husband of unknown age. The patient was vaccinated with a dose of .65 ml ZOSTAVAX (Lot# not reported) via intramuscular route rather than subcutaneous route on 09-JUL-2012. No other co-suspects were reported. No concomitant medications were reported. The patient experienced little bit of pain at the injection site. The nurse also stated that most patients (specific number of patients unspecified) who received ZOSTAVAX in her office would say they did not feel anything at the time of injection but felt medication in them after little while. The patient did not seek medical attention. At the time of reporting, the patient's outcome was unknown. Additional information is not expected.
Age: 30.0
Sex: F
Vaccine: HEP
Symptoms: Expired drug administered, No adverse event, Seroconversion test
Clinical narrative: Information has been received from a registered nurse concerning a currently 30 year old female who on 27-JUN-2012 was vaccinated in the left arm with the third dose of of hepatitis B virus vaccine rHBsAg (lot number AHBV803AB expiration date April 2012, dose and route not reported). The registered nurse stated that the patient was having a titer drawn to see if she seroconverted. No adverse effects reported. Lot number AHBVB803AB is an invalid lot number for Hepatitis B Vaccine (Recombinant). No further information is available.
Sex: U
Vaccine: VARZOS
Symptoms: Injection site inflammation
Clinical narrative: This spontaneous report as received from an about 50 years old female patient. The patient was vaccinated with a dose of ZOSTAVAX (Lot# and route not reported). No other co-suspects were reported. No concomitant medications were reported. The patient developed an injection site reaction when vaccinated with ZOSTAVAX. The injection site reaction was an inflamed red area which resolved in about a week. It was not painful. Additional information has been requested.
Sex: U
Vaccine: HEPA
Symptoms: Unevaluable event
Clinical narrative: This spontaneous report was received from a physician refers to a patient of unknown age. On an unknown date, the patient was vaccinated with the first dose of VAQTA (dose, route and lot # not provided). No other co-suspects were reported. No concomitant medications were reported. The physician reported that the patient might possibly have received dose 1 and dose 2 of VAQTA (dose, route and lot # not provided) separated by a 10 year period but this could not be confirmed at the time of the report. This is one of several reports received from the same source. Additional information has been requested.
Age: 2.0
Sex: M
Vaccine: HEPA
Symptoms: Eye movement disorder
Clinical narrative: Hard blinking of the eyes.
Age: 35.0
Sex: F
Vaccine: MMR
Symptoms: Rash
Clinical narrative: Rash on Stomach, Lasted One Night - was gone in the morning.  No treatment.
Age: 5.0
Sex: M
Vaccine: MNQ, PNC13, VARCEL
Symptoms: Pyrexia, Urticaria
Clinical narrative: 7/3/2012 AM fever of ~101 throughout the dat (treated with ibuprofen). 7/4/2012 AM hives all over body for most of the day, repeated treatment with oral Benadryl and topical hydrocortisone.
Age: 45.0
Sex: F
Vaccine: MNQ
Symptoms: Pyrexia, Vaccination site swelling
Clinical narrative: Site of vaciine is swollen and patient feel feverish.
Age: 30.0
Sex: F
Vaccine: DTAP
Symptoms: Lymph node pain, Lymphadenopathy
Clinical narrative: Sswelled gland on neck very painful.
Age: 87.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site erythema, Injection site pruritus, Injection site rash, Injection site warmth
Clinical narrative: Red, slightly raised area at the injection site. Warm to touch and patient complained of itching. Diameter measured 2 inches.
Age: 1.02
Sex: F
Vaccine: HEPA, MMR, VARCEL
Symptoms: Blister, Cough, Herpes zoster, Pyrexia, Viral test positive
Clinical narrative: 14 MONTH old with cough, congestion for 4 days; had fever for the first 2 days of illness, but none since.  Developed grouped blisters on medial aspect of right foot 3 days ago. Not sure if they are painful or not.
Age: 34.0
Sex: F
Vaccine: MMR, TDAP
Symptoms: Erythema, Urticaria
Clinical narrative: URTICARIA. ITCH A LOT GOING ON AROUND THE BODY TO DIFFERENT AREAS AND RED SKIN.
Age: 67.0
Sex: F
Vaccine: VARZOS
Symptoms: Rash
Clinical narrative: Patient developed rash on buttocks/leg.
Age: 71.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site erythema, Injection site pruritus, Injection site rash, Injection site swelling, Injection site warmth
Clinical narrative: Pt. received vaccine 7/12/12. Reported a rash/rxn at injection site on 7/13/12, red, raised area about baseball-sized still evident on 7/15, slightly itchy, warm to touch. Took BENADRYL 7/15 upon talking to RPh.
Age: 72.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site reaction, Urticaria
Clinical narrative: Large welt appeared around injection site.
Age: 27.0
Sex: M
Vaccine: MNQ
Symptoms: Loss of consciousness, Mydriasis, Respiratory arrest
Clinical narrative: Patient passed out, eye dilated, may have stopped breathing. No treatment was needed.
Age: 58.0
Sex: F
Vaccine: VARZOS
Symptoms: Dizziness, Nausea, Rash
Clinical narrative: On 6/19/12 pt went to get shingles vaccine. Around 10:00 AM admin. Pt. felt dizzy & nauseous. When pt took Bandage off 3 days later she had a very bad rash.
Age: 5.0
Sex: F
Vaccine: DTAPIPV
Symptoms: Injection site erythema, Injection site pain, Injection site pruritus, Injection site rash, Injection site swelling
Clinical narrative: Ins itchy sore -> then swollen & red -> then with bumps (hives).
Age: 5.0
Sex: F
Vaccine: DTAPIPV
Symptoms: Injection site urticaria
Clinical narrative: Ins itchy sore -> then swollen & red -> then with bumps (hives).
Age: 1.4
Sex: M
Vaccine: VARCEL
Symptoms: Pyrexia, Rash generalised, Rash vesicular
Clinical narrative: Information has been received from a pharmacy student concerning a 17 month old male patient with no medical history and no drug allergy/reaction who on 06-FEB-2012 was vaccinated SQ with a dose of VARIVAX (Merck) (lot # 671130/1220AA). There was no concomitant medication. On 11-APR-2012 the patient developed varicella like rash all over the body along with febrile illness after receiving VARIVAX (Merck). There was no laboratory studies performed. The patient came into the clinic to seek medical attention and was given no treatment for AEs. At the time of the report, the patient's outcome was unknown. This is one of several cases reported by the same source. A preliminary lot check investigation was performed. To date our investigation has found that this lot confirmed to quality release parameters and the manufacturing was typical of a lot of VARIVAX (Merck). Additional information will be provided upon finalization of this manufacturing investigation. Additional information has been requested.
Age: 75.0
Sex: F
Vaccine: VARZOS
Symptoms: Herpes zoster, Rash
Clinical narrative: This spontaneous report as received from a 77 years old female patient with diabetes, high blood pressure, cyst and no drug reactions/allergies. The patient was subcutaneously vaccinated with, 0.65 ml ZOSTAVAX on 27-AUG-2009 (lot# was unspecified). Concomitant medications included CEPHALEXIN, heart medication (unspecified) and diabetes medication (unspecified). On 03-JUL-2012 the patient had a rash and has been diagnosed with shingles by her doctor, 1042 days after onset of therapy. Treatment given for AE included ACYCLOVIR, prednisone and GABAPENTIN. The outcome of shingles was reported as not recovered/not resolved. No lab diagnostic study were performed. Additional information has been requested.
Sex: M
Vaccine: PPV
Symptoms: Influenza like illness, Local reaction
Clinical narrative: This spontaneous report as received from a pharmacist refers to her husband of unknown age. The patient was vaccinated with PNEUMOVAX 23 (dose, route and lot # not reported) in 2007. No other co-suspects were reported. No concomitant medications were reported. On an unknown date the patient experienced local reaction and flu-like symptoms after receiving a dose of PNEUMOVAX 23 in 2007. It was unknown if the patient sought medical attention. The outcome of flu-like symptoms and local reaction was unknown. Additional information has been requested.
Age: 18.0
Sex: F
Vaccine: VARCEL
Symptoms: Antibody test negative
Clinical narrative: This spontaneous report as received from a medical assistant refers to a 19 years old female patient. The patient was vaccinated with the first and third dose of VARIVAX (lot# and exp. date were unspecified) in unspecified pediatrician's office on 25-JAN-1996 and 01-JUL-2011. It is a pregnancy registry products No other co-suspects were reported. No concomitant medications were reported. Varicella antibody titers on 10-APR-2012 were low at 0.59 (positive is >1.10). A booster dose of VARIVAX (lot#671128/1060AA exp.05-JUL-2013) was given on 13-APR-2012. Varicella antibody titers on 10-APR-2012 were low at 0.88. The patient had sought medical attention via office visit. No treatment information was reported. At the report time the patient still had low antibody titers. Additional information has been requested.
Age: 16.0
Sex: M
Vaccine: HPV4
Symptoms: Chills, Pyrexia
Clinical narrative: This spontaneous report as received from a healthcare worker refers to a 16 years old male patient with drug allergy to amoxicillin and without pertinent medical history. The patient was vaccinated intramuscularly with 0.5 ml GARDASIL (lot number unknown) on 03-JUL-2012. No other co-suspects were reported. There is no concomitant therapy. The patient developed fever and chills after receiving GARDASIL on 03-JUL-2012. No laboratory diagnostic studies were performed. The patient had contacted HCP office for medical attention. MOTRIN and TYLENOL were given as treatment for the events. The outcome was reported as recovered on 5-JUL-2012. Additional information is not expected.
Age: 4.0
Sex: U
Vaccine: VARCEL
Symptoms: Varicella post vaccine
Clinical narrative: Information has been received from a nurse concerning a 4 year old patient who on 31-MAR-2009 was vaccinated with the first dose of VARIVAX (Merck) (lot# 662201/1544X). The nurse mentioned that on 15-MAY-2012 the patient had outbreaks of varicella. The patient had contacted the office. At the time of the report, the patient's status was unknown. This was one of the several reports from the same source. On 07-JUN-2012 the patient was vaccinated with a second dose of VARIVAX (Merck) (lot# 671474/1381AA). A lot check has been initiated. Additional information has been requested.
Sex: U
Vaccine: HPV4
Symptoms: Nervous system disorder
Clinical narrative: This spontaneous report as received from a medical assistant refers to a patient of unknown age. The patient was vaccinated with GARDASIL (lot number unknown) on an unknown date. No other co-suspects were reported. No concomitant medications were reported. On an unknown date the patient experienced a "neurological impairment". It was unspecified if the patient had sought medical attention. The outcome of neurological impairment is unknown. This is one of several reports received from the same source. Additional information has been requested.
Age: 69.0
Sex: F
Vaccine: PPV, PPV
Symptoms: Full blood count, Laboratory test, Neck pain, Nodule, Pyrexia
Clinical narrative: This spontaneous report as received from a medical assistant (also reported as a healthcare worker) refers to a 69 years old female patient. The patient was vaccinated with PNEUMOVAX23 (lot# 671038/0811AA, expiration date 15-MAR-2013) (route unspecified) on 21-OCT-2011. No other co-suspects were reported. No concomitant medications were reported. On 24-OCT-2011 the patient experienced myalgia and a warm area on her left arm where PNEUMOVAX23 was given. The warm area worsened on 28-OCT-2011 and on 02-NOV-2011 the patient had problems with her left leg with pain and swelling. On 07-NOV-2011 the patient experienced numbness and tingling down left arm with elevated white blood cell (WBC) count (17,000) and elevated "sed rate" (sedimentation rate). The patient went to Hospital in February 2012. While in the hospital, the patient had surgery done to inflammation and "something in her neck". The outcome was fatal (also reported as recovering). The patient died on an unknown date in 2012 (cause of death unspecified). The medical assistant stated that a VAERS form was completed for this case. All the reactions were considered significant disability or incapacity and life threatening. Additional information has been requested.
Age: 69.0
Sex: F
Vaccine: PPV, PPV
Symptoms: Serum sickness, X-ray
Clinical narrative: This spontaneous report as received from a medical assistant (also reported as a healthcare worker) refers to a 69 years old female patient. The patient was vaccinated with PNEUMOVAX23 (lot# 671038/0811AA, expiration date 15-MAR-2013) (route unspecified) on 21-OCT-2011. No other co-suspects were reported. No concomitant medications were reported. On 24-OCT-2011 the patient experienced myalgia and a warm area on her left arm where PNEUMOVAX23 was given. The warm area worsened on 28-OCT-2011 and on 02-NOV-2011 the patient had problems with her left leg with pain and swelling. On 07-NOV-2011 the patient experienced numbness and tingling down left arm with elevated white blood cell (WBC) count (17,000) and elevated "sed rate" (sedimentation rate). The patient went to Hospital in February 2012. While in the hospital, the patient had surgery done to inflammation and "something in her neck". The outcome was fatal (also reported as recovering). The patient died on an unknown date in 2012 (cause of death unspecified). The medical assistant stated that a VAERS form was completed for this case. All the reactions were considered significant disability or incapacity and life threatening. Additional information has been requested.
Age: 69.0
Sex: F
Vaccine: PPV, PPV
Symptoms: Death, Hypoaesthesia, Inflammation, Injection site warmth, Musculoskeletal discomfort
Clinical narrative: This spontaneous report as received from a medical assistant (also reported as a healthcare worker) refers to a 69 years old female patient. The patient was vaccinated with PNEUMOVAX23 (lot# 671038/0811AA, expiration date 15-MAR-2013) (route unspecified) on 21-OCT-2011. No other co-suspects were reported. No concomitant medications were reported. On 24-OCT-2011 the patient experienced myalgia and a warm area on her left arm where PNEUMOVAX23 was given. The warm area worsened on 28-OCT-2011 and on 02-NOV-2011 the patient had problems with her left leg with pain and swelling. On 07-NOV-2011 the patient experienced numbness and tingling down left arm with elevated white blood cell (WBC) count (17,000) and elevated "sed rate" (sedimentation rate). The patient went to Hospital in February 2012. While in the hospital, the patient had surgery done to inflammation and "something in her neck". The outcome was fatal (also reported as recovering). The patient died on an unknown date in 2012 (cause of death unspecified). The medical assistant stated that a VAERS form was completed for this case. All the reactions were considered significant disability or incapacity and life threatening. Additional information has been requested.
Age: 69.0
Sex: F
Vaccine: PPV, PPV
Symptoms: Myalgia, Oedema peripheral, Pain in extremity, Paraesthesia, Red blood cell sedimentation rate increased
Clinical narrative: This spontaneous report as received from a medical assistant (also reported as a healthcare worker) refers to a 69 years old female patient. The patient was vaccinated with PNEUMOVAX23 (lot# 671038/0811AA, expiration date 15-MAR-2013) (route unspecified) on 21-OCT-2011. No other co-suspects were reported. No concomitant medications were reported. On 24-OCT-2011 the patient experienced myalgia and a warm area on her left arm where PNEUMOVAX23 was given. The warm area worsened on 28-OCT-2011 and on 02-NOV-2011 the patient had problems with her left leg with pain and swelling. On 07-NOV-2011 the patient experienced numbness and tingling down left arm with elevated white blood cell (WBC) count (17,000) and elevated "sed rate" (sedimentation rate). The patient went to Hospital in February 2012. While in the hospital, the patient had surgery done to inflammation and "something in her neck". The outcome was fatal (also reported as recovering). The patient died on an unknown date in 2012 (cause of death unspecified). The medical assistant stated that a VAERS form was completed for this case. All the reactions were considered significant disability or incapacity and life threatening. Additional information has been requested.
Age: 69.0
Sex: F
Vaccine: PPV, PPV
Symptoms: Surgery, White blood cell count increased
Clinical narrative: This spontaneous report as received from a medical assistant (also reported as a healthcare worker) refers to a 69 years old female patient. The patient was vaccinated with PNEUMOVAX23 (lot# 671038/0811AA, expiration date 15-MAR-2013) (route unspecified) on 21-OCT-2011. No other co-suspects were reported. No concomitant medications were reported. On 24-OCT-2011 the patient experienced myalgia and a warm area on her left arm where PNEUMOVAX23 was given. The warm area worsened on 28-OCT-2011 and on 02-NOV-2011 the patient had problems with her left leg with pain and swelling. On 07-NOV-2011 the patient experienced numbness and tingling down left arm with elevated white blood cell (WBC) count (17,000) and elevated "sed rate" (sedimentation rate). The patient went to Hospital in February 2012. While in the hospital, the patient had surgery done to inflammation and "something in her neck". The outcome was fatal (also reported as recovering). The patient died on an unknown date in 2012 (cause of death unspecified). The medical assistant stated that a VAERS form was completed for this case. All the reactions were considered significant disability or incapacity and life threatening. Additional information has been requested.
Age: 56.0
Sex: M
Vaccine: VARZOS, VARZOS
Symptoms: Oral herpes
Clinical narrative: Information has been received from a pharmacist concerning a 56 year old male patient with hypertension, high cholesterol and no drug reactions or allergies who on 09-MAY-2012, was subcutaneously vaccinated with a dose of ZOSTAVAX (Merck) (lot number: 672867/0241AE). Concomitant therapy included lisinopril (manufacturer unknown). On 10-MAY-2012, the patient developed a cold sore in an unspecified area. Thus, he decided to take 400 mg of acyclovir. There were no laboratory tests performed. The patient sought medical attention by contacting the pharmacy. At the time of reporting, patient had not recovered. Follow-up information was received from the physician who stated that the patient did not received ZOSTAVAX (Merck) in the office and was not aware of where and when he did. Follow-up information has been received from the pharmacist refers to the 56 year old male patient with hypertension and hypercholesterolemia, who had previous cold sore issues. The patient was subcutaneously vaccinated with the first dose of ZOSTAVAX (lot number 672867/0241AE) at his left arm at 14:25 on 09-MAY-2012. On 10-JUN-2012 the patient woke up with cold sores on face. The patient took 2 tablets of acyclovir 200 mg. The patient reported to a physician who stated this was fine. The outcome of cold sores on face was reported as recovered/resolved. Additional information is not expected.
Age: 56.0
Sex: M
Vaccine: VARZOS, VARZOS
Symptoms: Condition aggravated, Oral herpes
Clinical narrative: Information has been received from a pharmacist concerning a 56 year old male patient with hypertension, high cholesterol and no drug reactions or allergies who on 09-MAY-2012, was subcutaneously vaccinated with a dose of ZOSTAVAX (Merck) (lot number: 672867/0241AE). Concomitant therapy included lisinopril (manufacturer unknown). On 10-MAY-2012, the patient developed a cold sore in an unspecified area. Thus, he decided to take 400 mg of acyclovir. There were no laboratory tests performed. The patient sought medical attention by contacting the pharmacy. At the time of reporting, patient had not recovered. Follow-up information was received from the physician who stated that the patient did not received ZOSTAVAX (Merck) in the office and was not aware of where and when he did. Follow-up information has been received from the pharmacist refers to the 56 year old male patient with hypertension and hypercholesterolemia, who had previous cold sore issues. The patient was subcutaneously vaccinated with the first dose of ZOSTAVAX (lot number 672867/0241AE) at his left arm at 14:25 on 09-MAY-2012. On 10-JUN-2012 the patient woke up with cold sores on face. The patient took 2 tablets of acyclovir 200 mg. The patient reported to a physician who stated this was fine. The outcome of cold sores on face was reported as recovered/resolved. Additional information is not expected.
Age: 31.0
Sex: M
Vaccine: HIBV, PPV, HIBV, PPV
Symptoms: Full blood count abnormal, Injected limb mobility decreased, Injection site erythema, Injection site pain, Injection site swelling
Clinical narrative: There were two adverse events related to this vaccine. First, a fever that started Thursday June 21, reaching 103.6 while I was in the ER.  The fever remained above 99.6 from Thursday until Sunday June 23, reaching 103.2 again on Saturday morning.  The second adverse event was the swelling in my right arm that started Friday morning with excruciating pain.  The swelling lasted until Thursday June 28 after being on strong antibiotics for 4 days.
Age: 31.0
Sex: M
Vaccine: HIBV, PPV, HIBV, PPV
Symptoms: Neutrophil count increased, Pyrexia, White blood cell count increased
Clinical narrative: There were two adverse events related to this vaccine. First, a fever that started Thursday June 21, reaching 103.6 while I was in the ER.  The fever remained above 99.6 from Thursday until Sunday June 23, reaching 103.2 again on Saturday morning.  The second adverse event was the swelling in my right arm that started Friday morning with excruciating pain.  The swelling lasted until Thursday June 28 after being on strong antibiotics for 4 days.
Age: 31.0
Sex: M
Vaccine: HIBV, PPV, HIBV, PPV
Symptoms: Oedema peripheral, Pain in extremity, Pyrexia
Clinical narrative: There were two adverse events related to this vaccine. First, a fever that started Thursday June 21, reaching 103.6 while I was in the ER.  The fever remained above 99.6 from Thursday until Sunday June 23, reaching 103.2 again on Saturday morning.  The second adverse event was the swelling in my right arm that started Friday morning with excruciating pain.  The swelling lasted until Thursday June 28 after being on strong antibiotics for 4 days.
Age: 11.0
Sex: F
Vaccine: HPV4, MNQ, TDAP, HPV4, MNQ, TDAP
Symptoms: Dyspnoea, Hypersensitivity, Swelling
Clinical narrative: Information has been received from a licensed practical nurse concerning a 11 year old female patient with no pertinent medical history and no drug allergies who on 06-APR-2011 was vaccinated with the first dose of GARDASIL (lot number, dose and site not reported). On the same date the patient also received the first dose of MENACTRA and Tdap (manufacturer unspecified). On 08-APR-2011, the patient experienced a systemic reaction with full body swelling and some difficulty breathing. The patient was taken to the emergency room of an unknown hospital and received steroids as treatment. Subsequently on an unspecified date, the patient recovered from systemic reaction, full body swelling and some difficulty breathing. Systemic reaction, full body swelling and some difficulty breathing was considered as other important medical event by the reporter. Follow up information has been received from the licensed practical nurse referring to the patient. The nurse indicated that she did not have the lot number for the vaccinations. The patient was seen in an unspecified hospital. The patient had received IV steroids (manufacturer unspecified) for the events. On 08-Apr-2011, the same day of the onset date, the patient recovered from the events. Additional information has been requested.