chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 32.0
Sex: F
Vaccine: TDAP
Symptoms: Injection site erythema, Injection site vesicles, Injection site warmth, Musculoskeletal pain, Myalgia
Clinical narrative: 12-24 after administrator, muscle soreness, body aches, fever, HA, chills, N/V x1, last day, severe back/shoulder pain (R) side, dizziness, fatigue blistered at site, red & warm.
Age: 32.0
Sex: F
Vaccine: TDAP
Symptoms: Nausea, Pain, Pyrexia, Vomiting
Clinical narrative: 12-24 after administrator, muscle soreness, body aches, fever, HA, chills, N/V x1, last day, severe back/shoulder pain (R) side, dizziness, fatigue blistered at site, red & warm.
Age: 16.0
Sex: M
Vaccine: HEPA, HPV4
Symptoms: Cold sweat, Hyperhidrosis, Pallor, Syncope
Clinical narrative: Pt had syncopal episode approx 10 min S/P HPV administration. Pt was pale, diaphoretic and clammy- spontaneously resolved. < 5-10 min.
Age: 16.0
Sex: F
Vaccine: HEPA, MNQ
Symptoms: Cellulitis
Clinical narrative: Cellulitis - received antibiotic treatment.
Age: 13.0
Sex: M
Vaccine: VARCEL
Symptoms: Dyspnoea, Hypersensitivity, Lacrimation increased, Rhinorrhoea
Clinical narrative: Allergic reaction: breathing difficulty, runny nose, eyes.
Age: 56.0
Sex: F
Vaccine: VARZOS
Symptoms: Asthenia, Decreased appetite, Dyspnoea exertional, Fatigue, Feeling hot
Clinical narrative: Pt experience swelling in feet, tiredness, weakness, mild SOB upon exertion (walking through a store), warmth, loss of appetite. Pt states that swelling and SOB had subsided but still feels mild warmth, tiredness. Continuing to monitor patient.
Age: 56.0
Sex: F
Vaccine: VARZOS
Symptoms: Oedema peripheral
Clinical narrative: Pt experience swelling in feet, tiredness, weakness, mild SOB upon exertion (walking through a store), warmth, loss of appetite. Pt states that swelling and SOB had subsided but still feels mild warmth, tiredness. Continuing to monitor patient.
Age: 81.0
Sex: F
Vaccine: VARZOS
Symptoms: Rash erythematous, Rash pruritic
Clinical narrative: The patient woke up with an itchy, red rash located below the injection site. She didn't seem overly concerned but wanted to let us know. She called her physician & has some hydrocortisone cream that she will be applying to the area.
Age: 71.0
Sex: M
Vaccine: PPV
Symptoms: Blindness, Skin swelling
Clinical narrative: Level 4: A level 3 reaction & increase LOS. Increased LOS til the evening of the same day vaccine was administered. Dermatologic (swelling).
Age: 45.0
Sex: U
Vaccine: ANTH
Symptoms: Arthropathy, Inflammation, Rash macular
Clinical narrative: From time to time skin get blotchy and bump become inflamed. Also joints are very poor and brittle.
Age: 3.0
Sex: M
Vaccine: DTAPIPV
Symptoms: Myoclonus
Clinical narrative: 5 days after KINRIX vaccine developed full body myoclonic jerks while asleep lasting for 2 nights. Jerks occurred frequently throughout the night but asymptomatic during day time. Resolved without any sequelae.
Age: 84.0
Sex: M
Vaccine: VARZOS
Symptoms: Injection site erythema, Pruritus
Clinical narrative: Redness around injection site extending couple/few inches from injection site - patient stated itching since injection.
Age: 21.0
Sex: F
Vaccine: TDAP
Symptoms: Unevaluable event
Clinical narrative: None stated.
Age: 75.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site erythema
Clinical narrative: Patient had local redness at injection site without edema today (7/30). Pharmacist on-duty recommended oral BENADRYL to treat reaction. Doctor gave her a steroid pack to treat.
Age: 56.0
Sex: F
Vaccine: TDAP
Symptoms: Injection site vesicles, Injection site warmth
Clinical narrative: Was administered a Tdap vaccine at approx 5:15pm. About 7pm that night I noticed the injection site had a big cluster of small blisters and the area warm. Within an hour had some water blisters appear under arms and other parts of arm and some on inner leg and few on face. Persisted for several days.
Age: 61.0
Sex: F
Vaccine: VARZOS
Symptoms: Erythema, Swelling
Clinical narrative: Redness, swollen size of goose egg (3-4 in) in next day 7/20/12 and still continue today 7/23/12 per patient's husband. I called patient today, the swollen is going down & no redness. She is fine now.
Age: 14.0
Sex: M
Vaccine: VARCEL
Symptoms: Injection site erythema, Injection site nodule, Injection site warmth
Clinical narrative: Knot red & warm at injection site "size of baseball".
Age: 18.0
Sex: M
Vaccine: MNQ
Symptoms: Anxiety, Dizziness, Syncope
Clinical narrative: 8/01/12 approx 2:40pm client, post vaccination, c/o lightheaded, dizzy, fainted & observed having possible seizure x 5 secs, while sitting on chair. Clinic staff assisted client onto floor in sitting position. EMS contacted, client refused transport to ER at hospital. B/P 130/80, R=24 P=88, non cyanotic observed. Client states gets anxiety episodes, had last episode last night & EMS was contacted. Client contacted mother took to ER at hospital released home no TX needed. FU with his PCP as needed & future vaccinations need lie down.
Age: 5.0
Sex: F
Vaccine: DTAPIPV, HEPA, MMR, VARCEL
Symptoms: Incorrect dose administered
Clinical narrative: Child given 2 Hepatitis A vaccines at same visit.
Age: 12.0
Sex: F
Vaccine: HEPA, HPV4, MNQ, TDAP, VARCEL
Symptoms: Dizziness, Immediate post-injection reaction, Loss of consciousness, Nausea, Syncope
Clinical narrative: Administed vaccine while patient seated.  Pt became nausated immediately after shots; stated she was dizzy; attempted to walk pateint to a bed in exam room.  Patient lost consciousness/fainted.  Safely assisted to floor with legs elevated.  Patient recovered in less than one minute.  Kept in health department additonal 20 minutes.
Age: 31.0
Sex: F
Vaccine: VARCEL
Symptoms: Injection site erythema, Injection site pruritus, Injection site rash
Clinical narrative: Area of redness and mild rash at injection site - about 1 inch wide and 3 inches long.  Patient states area felt itchy. Denies systemic symptoms.
Age: 11.0
Sex: F
Vaccine: MNQ, TDAP
Symptoms: Injection site swelling, Swelling
Clinical narrative: Patient had arm swelling in the arm shoulder and armpit area. In the Left arm.
Age: 18.0
Sex: F
Vaccine: HPV4, MNQ, TDAP, VARCEL
Symptoms: Injection site erythema, Injection site pruritus, Injection site swelling, Injection site warmth, Tenderness
Clinical narrative: Patient in tohave TB skin test read and asked nurse to look at right arm.  Noted 3 x 3 inch red, swollen area to right back arm.  Patient states this is where varicella was given.  She stated it swelled yesterday and it itches.  Warm to touch. RN Called patient 08/07/12 States arm feels much better and is no longer tender or warm.  Patient states she applied compresses every two hours until arm recovered.
Age: 51.0
Sex: M
Vaccine: TDAP
Symptoms: Lymphadenopathy, Nodule, Pain, Tenderness
Clinical narrative: Pt. woke up from nap at 6 pm. Discovered a golf-ball sized nodule at inner aspect lower left axillary region. Soreness noted, no redness.  She went to facility, was seen by provider who thought Tdap was the etiology of the swollen lymph node.  She had no redness at site and her WBC count was not elevated.  The nodule is slowly reducing in size and becoming less tender.
Age: 48.0
Sex: F
Vaccine: PPV
Symptoms: Abscess, Cellulitis, Erythema, Pain, Swelling
Clinical narrative: Redness, Swelling, Pain led to Cellulitis and Abscess of Upper Arm.
Age: 12.0
Sex: M
Vaccine: HPV4, MNQ, TDAP, VARCEL
Symptoms: Burning sensation, Injection site erythema, Injection site induration, Injection site swelling, Injection site warmth
Clinical narrative: Mother brought child in for nurse to look @ left arm.  Said he woke up @ 5 a.m. c/o of burning @ left arm.  Nurse noted area on L back upper arm total red area.  4 x 4 inches with inner hard area of 2 x 1 inches, swollen and warm to touch.
Age: 11.0
Sex: F
Vaccine: HPV4, MNQ, TDAP
Symptoms: Pruritus, Rash, Urticaria
Clinical narrative: Per patients mom, who called 6/6/12, patient had reaction after receiving 3 vaccines (MCV, HPV, TdaP) on 5/29/12. Patient had rash and hives from that evening on through yesterday. Stated on 6/6/12 itching has resolved. Provider advised mother to give patient antihistamine for rash, but mother states patient refuses to take medication.
Age: 5.0
Sex: M
Vaccine: DTAPIPV, MMR, VARCEL
Symptoms: Cough, Discomfort, Throat irritation
Clinical narrative: Mom returned to clinic around 25 min after the vaccines were given. Child received Kinrix, MMR, Varicella. Mom asked for a nurse, and reported child c/o itchy throat. Child did not appear to be in distress, coughing off/ on, no hives noted, and could not sit still. While doing assessment on child, mom already was talking to 911. Mom stated to nurse had a reaction to MMR as a child - eyes swollen and resolved w/ Benadryl, denies anaphylaxis. Paramedics arrived and took over assessment and interventions. Administered epi to child, went to closest ER. I followed w/ mother @ 1:57 pm and 6:20 pm- and reports PT is stable. Discharged w/ Prednisone per mother.
Age: 64.0
Sex: F
Vaccine: VARZOS
Symptoms: Cellulitis, Erythema, Malaise, Oedema peripheral, Pain in extremity
Clinical narrative: Arm swollen, red, and painful and pt reported not feeling well. Pt got antibiotics for cellulitis.
Age: 1.02
Sex: F
Vaccine: HEPA, MMR, VARCEL
Symptoms: Injection site rash, Irritability, Pyrexia
Clinical narrative: Developed fever, fussiness and rash at site of injection.
Age: 36.0
Sex: M
Vaccine: TDAP
Symptoms: Chills, Dizziness, Headache, Nausea, Pain
Clinical narrative: Fever of 101, chills, body aches, head ache, dizziness, nausea - symptoms relieved with Tylenol.
Age: 36.0
Sex: M
Vaccine: TDAP
Symptoms: Pyrexia
Clinical narrative: Fever of 101, chills, body aches, head ache, dizziness, nausea - symptoms relieved with Tylenol.
Age: 70.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site scab
Clinical narrative: Scab at injection site - diagnosed as possible hematoma - patient received antibiotic.
Age: 68.0
Sex: F
Vaccine: VARZOS
Symptoms: Herpes zoster, Rash vesicular
Clinical narrative: Shingles on stomach for 5 days then changed in to what seemed like chicken pox.  Currently still battling the symptoms of this shot.
Age: 25.0
Sex: M
Vaccine: HEP, TDAP
Symptoms: Immediate post-injection reaction, Seizure like phenomena
Clinical narrative: Seizure like activity immediately following vaccine administration.
Age: 12.0
Sex: F
Vaccine: HPV4, IPV, MNQ, TDAP
Symptoms: Blood glucose normal, Haemoglobin normal, Loss of consciousness, Syncope
Clinical narrative: After receiving multiple vaccines (total count #4) and having been observed for 10 minutes post-vaccine administration, patient was exiting clinic and fainted at discharge desk. She was able to regain consciousness immediately, understood where she was and was assisted in rising by clinic staff. She was then placed in wheelchair and taken to an exam room for further evaluation and observation by an in house nurse practitioner. Her BP was stable 90/60, pulse was 70, Resp rate 18, Hemoglobin 13.5 and fasting glucose 102 mg/dL. We provided the patient with some juice and crackers and continued to monitor her for 30 minutes, at 10 minute intervals until she was able to ambulate without assistance or further threat of imbalance.
Age: 75.0
Sex: F
Vaccine: VARZOS
Symptoms: Cerebral ischaemia, Endotracheal intubation, Grand mal convulsion, Mental status changes, Nuclear magnetic resonance imaging brain abnormal
Clinical narrative: Pt presented to ER with altered mental status, 3 grand mal seizures witnessed by staff, required oral endotracheal intubation.
Age: 19.0
Sex: F
Vaccine: MNQ
Symptoms: Asthenia, Headache, Pain in extremity, Vomiting
Clinical narrative: Woke up this morning and arm was sore, was at work started to develop a headache.  Went home vomited and has been "weak" all day.
Age: 35.0
Sex: F
Vaccine: MMR
Symptoms: Food allergy, Pharyngeal oedema
Clinical narrative: Developed an egg allergy less than 24 hrs after receiving vaccine, 35 yrs always ate egg without a problem, from that point on my throat swells whenever eating eggs.
Age: 24.0
Sex: F
Vaccine: TDAP
Symptoms: Muscle spasms, Pruritus generalised
Clinical narrative: Muscle cramps in hamstrings, biceps, and abdomen. Itching all over. No rash.
Age: 15.0
Sex: M
Vaccine: HEPA, HPV4
Symptoms: Dyskinesia, Head injury, Laceration, Seizure like phenomena, Syncope
Clinical narrative: Approx. 5 mins. following vaccination with HPV #1 vaccine (Gardasil)and Hep A#1 vaccine (Havrix) pt. had vasovagal syncope episode with short (4-5 seconds) of seizure-like jerky movements. Pt. hit forehead on piece of equipmemt in exam room which resulted in 1mm laceration that was cleaned and bandaged. Pt. became responsive in 5 seconds. Father & APN witnessed episode. The pt. was placed flat on an exam table with a cool compress and was observed for 30 minutes. After this time he was evaluated and found to be alert and responsive and was cleared to leave the clinic area with his father.
Age: 15.0
Sex: M
Vaccine: HEPA, HPV4
Symptoms: Unresponsive to stimuli
Clinical narrative: Approx. 5 mins. following vaccination with HPV #1 vaccine (Gardasil)and Hep A#1 vaccine (Havrix) pt. had vasovagal syncope episode with short (4-5 seconds) of seizure-like jerky movements. Pt. hit forehead on piece of equipmemt in exam room which resulted in 1mm laceration that was cleaned and bandaged. Pt. became responsive in 5 seconds. Father & APN witnessed episode. The pt. was placed flat on an exam table with a cool compress and was observed for 30 minutes. After this time he was evaluated and found to be alert and responsive and was cleared to leave the clinic area with his father.
Age: 18.0
Sex: F
Vaccine: MNQ
Symptoms: Headache, Rash pruritic
Clinical narrative: Headache starting three hours after vaccines administration. Woke up with a headache the next day as well. Also developed itchy facial rash the following day on 8/7/2012 at 10:00 AM.
Age: 17.0
Sex: F
Vaccine: MNQ
Symptoms: Dizziness, Full blood count, Pallor, Tremor
Clinical narrative: 12:20 pm Patient became shaky and pale (dizzy) while doing a fingerstick (CBC) after she had the Menactra vaccine. It only lasted about 1 minute then patient was laid down, glucose given (lollipop), Dr. informed and reassessed the patient, check BP 84/58.
Age: 19.0
Sex: F
Vaccine: FLU3
Symptoms: Dizziness, Nausea, Vomiting
Clinical narrative: PATIENT BECAME NAUSEOUS AND VOMITED ABOUT 30 MINUTES FOLLOWING IMMUNIZATION.  FOR THE NEXT DAY SHE DESCRIBED FEELING DIZZY.
Age: 19.0
Sex: M
Vaccine: SMALL
Symptoms: Feeling hot, Injection site abscess, Swelling
Clinical narrative: Patient developed abscess at smallpox innoculation site (Left Deltoid). Pt noticed warmth and swelling on above date, and visited local ER on 5Aug12 for treatment, then again on 6Aug12 for followup. Pt was diagnosed with a general Abscess by ER, and prescribed antibiotics. Lesion was NOT drained, in part due to the smallpox innoculation that had been recieved. Pt then followed up with local military clinic, where he was observed to be improving.
Age: 14.0
Sex: M
Vaccine: MNQ
Symptoms: Syncope
Clinical narrative: Syncope Brief period followed by full memory and normal activity.  No other Symptoms.
Age: 1.66
Sex: M
Vaccine: DTAP
Symptoms: Extensive swelling of vaccinated limb, Injection site erythema, Injection site warmth
Clinical narrative: Very swollen red hot leg. Swollen up to 2 times size of leg.
Age: 28.0
Sex: F
Vaccine: DTP, PPV
Symptoms: Allergy to vaccine, Asthenia, Balance disorder, Blindness, Blood test
Clinical narrative: 5:40-5:55 AM: Almost passed out, black zig-zag lines in eyes, loss of vision, almost fell to ground, dizziness, weakness in both arms and both legs, brief period of profuse sweating, chills lasting throughout the day, fever, headache in area just above forehead and around eyes (a lot of pressure, pounding headache), rapid heart beat, ringing in ears, loss of balance and strength. 7:10 AM: Admitted to ER. Approx. 11:00 AM: Diagnosed with adverse reaction/allergy to pneumonia vaccine and diphtheria/tetanus/pertussis vaccine, given Tylenol and Ibuprofen for pain. Late in evening, approx. 9:00 PM: discovered redness, swelling, and blotches on right arm in area of vaccine. Late on 08/04/12 through present: severe pain on right arm at pneumonia vaccine site.
Age: 28.0
Sex: F
Vaccine: DTP, PPV
Symptoms: Chills, Dizziness, Electrocardiogram, Eye pain, Headache
Clinical narrative: 5:40-5:55 AM: Almost passed out, black zig-zag lines in eyes, loss of vision, almost fell to ground, dizziness, weakness in both arms and both legs, brief period of profuse sweating, chills lasting throughout the day, fever, headache in area just above forehead and around eyes (a lot of pressure, pounding headache), rapid heart beat, ringing in ears, loss of balance and strength. 7:10 AM: Admitted to ER. Approx. 11:00 AM: Diagnosed with adverse reaction/allergy to pneumonia vaccine and diphtheria/tetanus/pertussis vaccine, given Tylenol and Ibuprofen for pain. Late in evening, approx. 9:00 PM: discovered redness, swelling, and blotches on right arm in area of vaccine. Late on 08/04/12 through present: severe pain on right arm at pneumonia vaccine site.
Age: 28.0
Sex: F
Vaccine: DTP, PPV
Symptoms: Heart rate increased, Hyperhidrosis, Injection site erythema, Injection site reaction, Injection site swelling
Clinical narrative: 5:40-5:55 AM: Almost passed out, black zig-zag lines in eyes, loss of vision, almost fell to ground, dizziness, weakness in both arms and both legs, brief period of profuse sweating, chills lasting throughout the day, fever, headache in area just above forehead and around eyes (a lot of pressure, pounding headache), rapid heart beat, ringing in ears, loss of balance and strength. 7:10 AM: Admitted to ER. Approx. 11:00 AM: Diagnosed with adverse reaction/allergy to pneumonia vaccine and diphtheria/tetanus/pertussis vaccine, given Tylenol and Ibuprofen for pain. Late in evening, approx. 9:00 PM: discovered redness, swelling, and blotches on right arm in area of vaccine. Late on 08/04/12 through present: severe pain on right arm at pneumonia vaccine site.
Age: 28.0
Sex: F
Vaccine: DTP, PPV
Symptoms: Muscular weakness, Pyrexia, Rash macular, Tinnitus, Urine analysis
Clinical narrative: 5:40-5:55 AM: Almost passed out, black zig-zag lines in eyes, loss of vision, almost fell to ground, dizziness, weakness in both arms and both legs, brief period of profuse sweating, chills lasting throughout the day, fever, headache in area just above forehead and around eyes (a lot of pressure, pounding headache), rapid heart beat, ringing in ears, loss of balance and strength. 7:10 AM: Admitted to ER. Approx. 11:00 AM: Diagnosed with adverse reaction/allergy to pneumonia vaccine and diphtheria/tetanus/pertussis vaccine, given Tylenol and Ibuprofen for pain. Late in evening, approx. 9:00 PM: discovered redness, swelling, and blotches on right arm in area of vaccine. Late on 08/04/12 through present: severe pain on right arm at pneumonia vaccine site.
Age: 28.0
Sex: F
Vaccine: DTP, PPV
Symptoms: Vaccination complication, Vaccination site pain
Clinical narrative: 5:40-5:55 AM: Almost passed out, black zig-zag lines in eyes, loss of vision, almost fell to ground, dizziness, weakness in both arms and both legs, brief period of profuse sweating, chills lasting throughout the day, fever, headache in area just above forehead and around eyes (a lot of pressure, pounding headache), rapid heart beat, ringing in ears, loss of balance and strength. 7:10 AM: Admitted to ER. Approx. 11:00 AM: Diagnosed with adverse reaction/allergy to pneumonia vaccine and diphtheria/tetanus/pertussis vaccine, given Tylenol and Ibuprofen for pain. Late in evening, approx. 9:00 PM: discovered redness, swelling, and blotches on right arm in area of vaccine. Late on 08/04/12 through present: severe pain on right arm at pneumonia vaccine site.
Age: 2.0
Sex: M
Vaccine: MMR, VARCEL
Symptoms: Pyrexia
Clinical narrative: High Grade fever 104 axilla with digital thermometer.
Age: 4.0
Sex: F
Vaccine: DTAP, MMR, TD, VARCEL
Symptoms: Abdominal pain upper, Angina pectoris, Dyspnoea, Pallor, Vomiting
Clinical narrative: My daughter started complaining that she couldn't breathe and said my heart hurts then she said her stomach hurts and then started throwing up really bad. She was pale but seems to have gotten better once she vomited.
Age: 64.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site erythema, Injection site pruritus, Injection site rash, Injection site vesicles
Clinical narrative: Noticed on 7/30/12. Patient noticed 8cm redness at injection site and about 3cm area of raised blisters. Advised patient to take oral BENADRYL and use hydrocortisone cream. Patient also described intense itching at the area. Advised patient to follow up with MD if SX persist > 1 day.
Age: 13.0
Sex: F
Vaccine: HPV4
Symptoms: Dyskinesia, Loss of consciousness, Pallor, Syncope
Clinical narrative: 8/1/12 Pallor, syncopy, jerking motions of upper body, unconscious few seconds x 2 within 30 min. period: tx: layed flat on back x 2 w/feet/legs elevated. BP taken. O2 Sat, HR taken slowly increased and ambulatory after approx 45min. post injection.
Age: 75.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site erythema, Injection site rash, Sinus headache
Clinical narrative: Red, round rash at injection area size of tennis ball. Lasted for 8 days (gone Day 8). Sinus headache 2nd day. Migraine pills didn't help which is unusual. Lasted until 2 AM 7-11-12 - fell asleep. All day headache sinus area and later over right eye.
Age: 15.0
Sex: F
Vaccine: HEPA, HPV4, MNQ
Symptoms: Loss of consciousness, Pallor
Clinical narrative: After administration of 3rd vaccine (HPV), client pale and started to pass out. Put her head between knees - was always responsive. Helped her to lie down on exam table and put ice pack behind neck. Took BP and pulse x 2. Condition rapidly improved. Left in good condition with mother and sister. Only had PopTart in AM - gave her 2 cups of water and told her to rest today and go home to have meal including protein. See PMD if problems.
Age: 39.0
Sex: U
Vaccine: JEV1, RAB
Symptoms: Dizziness, Head discomfort, Tremor
Clinical narrative: JE IXAIRO #2 Rabies RabAvert #3 administered 10 mins passed. Pt light headed, dizzy, heavy feeling across forehead, shaking.
Age: 11.0
Sex: F
Vaccine: HPV4, MEN
Symptoms: Headache, Injection site erythema, Injection site swelling, Injection site warmth, Malaise
Clinical narrative: Within 24 hrs of injection patients right arm swelled at injection site, red, and warm to touch. Patient developed headache and malaise.
Age: 19.0
Sex: F
Vaccine: MNQ
Symptoms: Blood pressure decreased, Fall, Hypoaesthesia, Loss of consciousness, Paraesthesia
Clinical narrative: Pat given MENVEO, was standing in line with parents. Passed out and fell to the floor. Regain consciousness but said right side was tingling and numb.
Age: 60.0
Sex: M
Vaccine: VARZOS
Symptoms: Herpes zoster
Clinical narrative: Pt. vaccinated with Zoster vaccine on 1-7-09, diagnosed with shingles on 7-31-12.
Age: 62.0
Sex: F
Vaccine: PPV
Symptoms: Mobility decreased, Pain
Clinical narrative: Pt. received vaccine on 7/27/12 and then could not raise arm past her shoulder without pain. Lasted until 8/2/12. On 8/3/12 said she had normal function. NO redness or warmth was at site.
Age: 12.0
Sex: F
Vaccine: HPV4
Symptoms: Contusion, Lip haematoma, Vaccine positive rechallenge
Clinical narrative: Bruise on chin/hematoma, including the lower lip. Same reaction happened after HPV#2 on 7/26/11.
Age: 0.58
Sex: M
Vaccine: DTAP
Symptoms: Hypotonic-hyporesponsive episode
Clinical narrative: Hypotonic hyporesponsive episode.
Age: 12.0
Sex: M
Vaccine: DTAPIPV, MMR
Symptoms: Body temperature increased, Dizziness, Nausea, Retching, Tremor
Clinical narrative: Pt reports temp 101, nausea, dry heaves, shakes, dizziness after receiving vaccine - approx 12 hours after immunization.
Age: 72.0
Sex: M
Vaccine: VARZOS
Symptoms: Cough, Erythema, Oedema peripheral, Pruritus
Clinical narrative: ZOSTAVAX given at 9:25 AM, Patient returned at 12:30 PM with a red, swollen arm, complaining of itching and a nagging cough. Patient given an Epipen dose (0.3 mg) in left thigh.
Age: 44.0
Sex: F
Vaccine: TDAP
Symptoms: Lymph node pain, Lymphadenopathy, Mobility decreased
Clinical narrative: Patient complained of pain and swelling of glands under arm and up into her mid chest beginning the day after the shot. Also had a difficult time moving her arm up.
Age: 16.0
Sex: M
Vaccine: FLU3, HPV4, MNQ
Symptoms: Axillary pain, Injection site erythema, Injection site swelling, Oedema peripheral
Clinical narrative: Within 24 hrs redness and swelling seen near but not at injection site ((L) deltoid). Then swelling to (L) axilla with pain and "fluid" felt in (L) axilla.
Age: 13.0
Sex: M
Vaccine: HPV4
Symptoms: Presyncope
Clinical narrative: Vasovagal episode.
Sex: M
Vaccine: FLU3, PPV
Symptoms: Injection site erythema, Injection site pain, Oedema peripheral
Clinical narrative: Began within same day - Arm very swollen and red (Rt arm). Presented to pharmacy 3 days later, less swollen, but redness down to elbow and very painful.
Age: 40.0
Sex: F
Vaccine: TDAP
Symptoms: Injected limb mobility decreased, Local swelling, Pain in extremity, Swelling
Clinical narrative: Monday 7-30-12 received shot in (L) arm. That night sore (L) arm. Began taking ADVIL every 4 hours. Tuesday 7-31-12 extreme (L) arm soreness with L ROM in (L) UE. At night began using moist heat on arm and neck. Wednesday 8-01-12 Unable to lift (L) arm, pain, swollen neck and armpit area.
Age: 19.0
Sex: F
Vaccine: TDAP
Symptoms: Dyspnoea, Hypoaesthesia, Malaise, Musculoskeletal pain, Pain
Clinical narrative: 1455 Tdap - RUA. C/O pain stinging above and in shoulder. C/O being sick. Sat down. Then went to DR emetic. Rash over arms, ankles, back down. 1507 Stated she had had diff. breath - numbness in front neck. BP 130/100. BENADRYL 50 IM, H20. BENADRYL 50 mg IM RA.
Age: 19.0
Sex: F
Vaccine: TDAP
Symptoms: Rash
Clinical narrative: 1455 Tdap - RUA. C/O pain stinging above and in shoulder. C/O being sick. Sat down. Then went to DR emetic. Rash over arms, ankles, back down. 1507 Stated she had had diff. breath - numbness in front neck. BP 130/100. BENADRYL 50 IM, H20. BENADRYL 50 mg IM RA.
Age: 12.0
Sex: F
Vaccine: HPV4
Symptoms: Headache, Pyrexia
Clinical narrative: Pt. received HPV #1, approximately 30 min after vaccine pt. developed HA & fever up to 101.1. Mother gave ibuprofen/Acetaminophen.
Age: 77.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site erythema, Injection site swelling, Local reaction
Clinical narrative: 4" in diameter circular red swollen area surrounding injection site of ZOSTAVAX.
Age: 65.0
Sex: M
Vaccine: FLU3, PPV
Symptoms: Myalgia, Pyrexia
Clinical narrative: 102 deg F fever, muscle soreness symptoms started 3-4 hours after vaccination.
Age: 11.0
Sex: F
Vaccine: HPV4, MNQ, TDAP
Symptoms: Deafness, Dyskinesia, Emotional distress, Syncope
Clinical narrative: Patient received TdAP, MCV, HPV at completion of third shot, her head jerked back & seemed to faint. Then sat up and said she could not hear, was very upset.
Age: 70.0
Sex: F
Vaccine: VARZOS
Symptoms: Headache
Clinical narrative: Pt. called pharmacy to report slight head since vaccine was administered in the morning. Pt. took Vicodin and headache resolved.
Age: 66.0
Sex: M
Vaccine: PPV
Symptoms: Diarrhoea, Injection site swelling, Malaise, Pyrexia
Clinical narrative: Fever, diarrhea, malaise, local swelling at site.
Age: 58.0
Sex: M
Vaccine: TDAP, VARZOS
Symptoms: Erythema, Joint effusion, Oedema peripheral, Pyrexia, Skin warm
Clinical narrative: Rt arm hot red swollen area on 8-4-12. Became increasingly red & warm measure 12 x 5 inches, low grade fever x 2 days. Area swollen with fluid over elbow.
Age: 41.0
Sex: M
Vaccine: VARCEL
Symptoms: Rash pruritic, Urticaria
Clinical narrative: Raised, itchy hive type rash starting 8:00p on date of varicella injection. Patient treated with OTC CLARITIN and BENADRYL x 5 days. Rash improved and subsided after 5-6 days.
Age: 51.0
Sex: F
Vaccine: YF
Symptoms: Dizziness, Fatigue, Headache, Influenza, Pain
Clinical narrative: Flu symptoms - headache, body aches, congestion, dizziness, fatigue started 6 days after vaccine lasted 5+ days. Treatment - OTC cad medicine, acetaminophen.
Age: 51.0
Sex: F
Vaccine: YF
Symptoms: Respiratory tract congestion
Clinical narrative: Flu symptoms - headache, body aches, congestion, dizziness, fatigue started 6 days after vaccine lasted 5+ days. Treatment - OTC cad medicine, acetaminophen.
Sex: U
Vaccine: HPV4
Symptoms: Incorrect storage of drug, No adverse event
Clinical narrative: Information has been received from a nurse (L.P.N.) concerning unspecified patients who on an unspecified date were vaccinated with improperly stored GARDASIL. The patients were not experiencing any known symptoms. Attempts are being made to obtain additional identifying information to distinguish the individuals patients mentioned in this report. Additional information will be provided if available. This is one of several reports from the same source. All telephone attempts to obtain follow-up information have been unsuccessful. Additional information has been requested.
Age: 16.0
Sex: M
Vaccine: HPV4, MNQ
Symptoms: Anxiety, Heart rate increased, Palpitations
Clinical narrative: This spontaneous report as received from the doctor's office manager refers to a 16 years old male patient. On approximately 17-JUL-2012 ("Tuesday or Wednesday of last week") the patient was vaccinated with a dose of 0.5 GARDASIL (Lot # and route not reported). Concomitant medications included: MENACTRA. The patient came to see doctor for this AE. About 10 minutes after the vaccination, the patient experienced heart palpitations, anxiety and pacing. No treatment was given. At the time of reporting, the outcomes were not reported. Additional information has been requested.
Sex: U
Vaccine: HPV4
Symptoms: Incorrect storage of drug, No adverse event
Clinical narrative: Information has been received from a Licensed Practical Nurse (L.P.N.) concerning unspecified patients who on an unspecified date were vaccinated with improperly stored GARDASIL. The patients were not experiencing any unknown symptoms. All telephone attempts to obtain follow up information have been unsuccessful. Additional information has been requested.
Age: 33.0
Sex: M
Vaccine: HPV4
Symptoms: Rash erythematous
Clinical narrative: This spontaneous report as received from a nurse practitioner refers to a 33 years old male patient with no pertinent medical history and no drug reactions/allergies. The patient was intramuscularly vaccinated with the first dose of GARDASIL (Lot #, dose were unspecified) on 23-MAY-2012. No other co-suspects were reported. No concomitant medications were used. It was reported that the patient was administered the dose in the GARDASIL series on 23-MAY-2012 and "within a couple of hours a red rash appeared on his neck and chest". The patient had sought medical attention via contacting physician via e-mail. No lab diagnostics studies performed. No treatment was given for AE. While the exact date the rash resolved was unknown, the nurse practitioner noted the rash "had resolved by 01-JUN-2012 but may have been earlier". No subsequent doses of GARDASIL had been administered. The outcome was reported as recovered/resolved. Additional has been requested.
Sex: U
Vaccine: VARCEL
Symptoms: Expired drug administered, No adverse event
Clinical narrative: This spontaneous report as received from a pharmacist refers to a patient of unknown age. On 02-AUG-2012, the patient was vaccinated with expired VARIVAX (Merck) (lot # 668431/0996Z, expired date 28-JUL-2012). No other co-suspects were reported. No concomitant medications were reported. No adverse effect reported. Additional information has been requested.
Age: 78.0
Sex: F
Vaccine: VARZOS
Symptoms: Blood test, Burning sensation, Laboratory test
Clinical narrative: This spontaneous report has been received from a consumer refers to the consumer's mother, a 78 years old female patient, with no drug allergy or concomitant medical history who was vaccinated SC with a 0.65 ml dose of ZOSTAVAX on an unspecified day in approximately MAY-2012 (reported as about two months ago). Concomitant medications included some unspecified medications. In approximately MAY-2012 (reported as about two months ago) the patient experienced a burning sensation throughout her body since having a ZOSTAVAX. The patient sought medical attention and physician had given the patient BENADRYL and LYRICA (manufacture and strengthen unspecified). Blood work and other unspecified tests were performed. At the time of report, the patient was not recovered. Additional information has been requested.
Age: 15.0
Sex: F
Vaccine: HPV4
Symptoms: Inappropriate schedule of drug administration, No adverse event
Clinical narrative: Information has been received from a medical assistant concerning an approximately 15 year old female patient who was vaccinated with the first and the second dose of GARDASIL (dose, route and lot numbers not reported) in 2010 and in 2011, respectively. No adverse effects reported. Follow-up information has been received from the medical assistant via B-form, concerning a 16 year old female patient, who was vaccinated with the first dose of GARDASIL on 20-AUG-2010 (dose, route and lot # not reported), with the second dose of GARDASIL I.M. in her left arm (dose not reported) (lot # 1009AA) on 19-AUG-2011 at 09:27 AM and with the third dose of GARDASIL (dose, route and lot # not reported) on 29-JUN-2012. No adverse reaction reported. Additional information is not expected.
Age: 17.0
Sex: M
Vaccine: HPV4
Symptoms: Inappropriate schedule of drug administration, No adverse event
Clinical narrative: Information has been received from a certified medical assistant concerning an unspecified number of patients who on unknown date, were vaccinated with the second or third dose of GARDASIL (dose, route, lot number not reported) late (dates unspecified). No adverse reactions reported. Telephone follow-up information has been received from the medical assistant. No further information was available at that time. Additional information has been requested.
Sex: F
Vaccine: VARZOS
Symptoms: Erythema, Oedema peripheral
Clinical narrative: This spontaneous report as received from a female consumer refers to herself. The patient was vaccinated with ZOSTAVAX (lot# was not reported) on 18-JUL-2012 "wednesday" and she experienced swelling and redness on the arm that she received the injection in July 2012. The patient took an anti-inflammatory medicine, ibuprofen. She also got her pharmacist to look at her arm. No other co-suspects were reported. No concomitant medications were reported. Additional information is not expected.
Age: 59.0
Sex: F
Vaccine: VARZOS
Symptoms: Burning sensation, Headache, Herpes zoster, Hyperhidrosis, Incorrect route of drug administration
Clinical narrative: Information has been received from a licensed practical nurse (L.P.N.), reporting on herself, who on 09-MAY-2012 was vaccinated with a dose of ZOSTAVAX (Merck) intramuscularly (dose and lot number not reported). Nurse reported that she received ZOSTAVAX (Merck) at the pharmacy but it was administered via intramuscular route rather than via subcutaneous route. No adverse effects were reported. Information has been received from the female licensed practical licensed practical nurse with a history of migraine who on 09-MAY-2012 was vaccinated with a dose of ZOSTAVAX (Merck) intramuscularly rather than subcutaneously. The nurse reported that after being administered ZOSTAVAX (Merck) on 09-MAY-2012 her "muscle hurt" where the vaccine was administered intramuscularly. The nurse also noted that on Saturday 12-MAY-2012 she woke at 7:00 am with headache in lower right portion of her head, with nausea and vomiting. The nurse noted she had "a history of migraines, but these symptoms were not from a migraine". The nurse also noted diaphoresis. All the events lasted for two hours then ended. On 12-MAY-2012, the patient recovered. Follow up information was received from the nurse who reported that last night, on 31-MAY-2012, she developed shingles. The shingles was described as itchy, burning rash on the left side of her waist. At the time of the report, the outcome of shingles was unknown. Follow up information was received from the nurse who reported that she became infected with shingles on 24-MAY-2012 (previously reported that she developed shingles on 31-MAY-2012) with diagnosis by physician's assistant. She was placed on acyclovir for 7 days. The rash was on her waist, left side of her back area (back rash area erupted 2 days after initial). At the time of the report, the outcome of shingles was unknown. Follow-up information was received from the nurse who reported that the vaccine was given IM (not SC) on 09-MAY-2012. On 12-MAY-2012 at 07:30 AM, severe headache, nausea, vomiting and diaphoresis lasted 2 hours. No treatment was given. Also the nurse got shingles 3 weeks after vaccine (previously reported as 31-MAY-2012). The patient recovered on 12-MAY-2012 from severe headache, nausea, vomiting and diaphoresis, the outcome of shingles was unknown. The patient did not seek medical attention. Additional information is not expected.
Age: 59.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site reaction, Myalgia, Nausea, Rash, Rash pruritic
Clinical narrative: Information has been received from a licensed practical nurse (L.P.N.), reporting on herself, who on 09-MAY-2012 was vaccinated with a dose of ZOSTAVAX (Merck) intramuscularly (dose and lot number not reported). Nurse reported that she received ZOSTAVAX (Merck) at the pharmacy but it was administered via intramuscular route rather than via subcutaneous route. No adverse effects were reported. Information has been received from the female licensed practical licensed practical nurse with a history of migraine who on 09-MAY-2012 was vaccinated with a dose of ZOSTAVAX (Merck) intramuscularly rather than subcutaneously. The nurse reported that after being administered ZOSTAVAX (Merck) on 09-MAY-2012 her "muscle hurt" where the vaccine was administered intramuscularly. The nurse also noted that on Saturday 12-MAY-2012 she woke at 7:00 am with headache in lower right portion of her head, with nausea and vomiting. The nurse noted she had "a history of migraines, but these symptoms were not from a migraine". The nurse also noted diaphoresis. All the events lasted for two hours then ended. On 12-MAY-2012, the patient recovered. Follow up information was received from the nurse who reported that last night, on 31-MAY-2012, she developed shingles. The shingles was described as itchy, burning rash on the left side of her waist. At the time of the report, the outcome of shingles was unknown. Follow up information was received from the nurse who reported that she became infected with shingles on 24-MAY-2012 (previously reported that she developed shingles on 31-MAY-2012) with diagnosis by physician's assistant. She was placed on acyclovir for 7 days. The rash was on her waist, left side of her back area (back rash area erupted 2 days after initial). At the time of the report, the outcome of shingles was unknown. Follow-up information was received from the nurse who reported that the vaccine was given IM (not SC) on 09-MAY-2012. On 12-MAY-2012 at 07:30 AM, severe headache, nausea, vomiting and diaphoresis lasted 2 hours. No treatment was given. Also the nurse got shingles 3 weeks after vaccine (previously reported as 31-MAY-2012). The patient recovered on 12-MAY-2012 from severe headache, nausea, vomiting and diaphoresis, the outcome of shingles was unknown. The patient did not seek medical attention. Additional information is not expected.
Age: 59.0
Sex: F
Vaccine: VARZOS
Symptoms: Vomiting
Clinical narrative: Information has been received from a licensed practical nurse (L.P.N.), reporting on herself, who on 09-MAY-2012 was vaccinated with a dose of ZOSTAVAX (Merck) intramuscularly (dose and lot number not reported). Nurse reported that she received ZOSTAVAX (Merck) at the pharmacy but it was administered via intramuscular route rather than via subcutaneous route. No adverse effects were reported. Information has been received from the female licensed practical licensed practical nurse with a history of migraine who on 09-MAY-2012 was vaccinated with a dose of ZOSTAVAX (Merck) intramuscularly rather than subcutaneously. The nurse reported that after being administered ZOSTAVAX (Merck) on 09-MAY-2012 her "muscle hurt" where the vaccine was administered intramuscularly. The nurse also noted that on Saturday 12-MAY-2012 she woke at 7:00 am with headache in lower right portion of her head, with nausea and vomiting. The nurse noted she had "a history of migraines, but these symptoms were not from a migraine". The nurse also noted diaphoresis. All the events lasted for two hours then ended. On 12-MAY-2012, the patient recovered. Follow up information was received from the nurse who reported that last night, on 31-MAY-2012, she developed shingles. The shingles was described as itchy, burning rash on the left side of her waist. At the time of the report, the outcome of shingles was unknown. Follow up information was received from the nurse who reported that she became infected with shingles on 24-MAY-2012 (previously reported that she developed shingles on 31-MAY-2012) with diagnosis by physician's assistant. She was placed on acyclovir for 7 days. The rash was on her waist, left side of her back area (back rash area erupted 2 days after initial). At the time of the report, the outcome of shingles was unknown. Follow-up information was received from the nurse who reported that the vaccine was given IM (not SC) on 09-MAY-2012. On 12-MAY-2012 at 07:30 AM, severe headache, nausea, vomiting and diaphoresis lasted 2 hours. No treatment was given. Also the nurse got shingles 3 weeks after vaccine (previously reported as 31-MAY-2012). The patient recovered on 12-MAY-2012 from severe headache, nausea, vomiting and diaphoresis, the outcome of shingles was unknown. The patient did not seek medical attention. Additional information is not expected.
Age: 17.0
Sex: M
Vaccine: HPV4
Symptoms: Abdominal pain upper, Gastritis
Clinical narrative: This spontaneous report as received from a physician refers to one of twin boys of unknown age. The patient received his first dose of GARDASIL (dose, route and lot number not reported) in October of 2011 and his second dose in July 2012 (dose, route and lot number not reported). No other co-suspects were reported. No concomitant medications were reported. In July 2012, at an unspecified time period post second dose, boy complained of stomach pain. Boy was seen by the physician who diagnosed him with gastritis. The patient was given ZANTAC as treatment. At the time of the report the outcome of gastritis was unknown. The relatedness for gastritis was unknown for GARDASIL. This is one of several reports received from the same source (MARRS # 1207USA012762). Additional information has been requested.
Age: 17.0
Sex: M
Vaccine: HPV4
Symptoms: Abdominal pain upper, Gastritis
Clinical narrative: This spontaneous report as received from a physician refers to one of twin boys of unknown age. The patient received his first dose of GARDASIL (dose, route and lot number not reported) in October of 2011 and his second dose in July 2012 (dose, route and lot number not reported). No other co-suspects were reported. No concomitant medications were reported. In July 2012, at an unspecified time period post second dose, boy complained of stomach pain. Boy was seen by the physician who diagnosed him with gastritis. The patient was given ZANTAC as treatment. At the time of the report the outcome of gastritis was unknown. The relatedness for gastritis was unknown for GARASIL. This is one of several received from the same source (MARRS # 1207USA006200). Additional information has been requested.
Age: 14.0
Sex: F
Vaccine: HPV4
Symptoms: Incorrect storage of drug, No adverse event
Clinical narrative: Initial and follow-up information has been received from a registered nurse and a medical assistant concerning a 14 year old female patient who on 02-JAN-2012 at 08:39 A.M. was vaccinated with the third dose of GARDASIL (lot number 670050/1229AA) I.M., into left deltoid (dose not reported) at private doctor's office/hospital. It was reported that the refrigerator temperature fell below range, below 30 degrees F over 16 day period. The vaccine was compromised. There were no adverse events reported. The patient did not require ED/Doctor visit. This is one of several reports received from the same source. No further information is available.
Age: 63.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site erythema, Injection site urticaria, Pain
Clinical narrative: This spontaneous report as received from a pharmacist refers to a 63 years old female patient with no drug reaction/allergies and no pertinent medical history, who on approximately 28-JUN-2012 ("a week before last week") was vaccinated with a dose of ZOSTAVAX (dose, route and lot # not reported). No other co-suspects were reported. No concomitant medications were reported. On the same date of administration of ZOSTAVAX the patient complained of pain and developed a red welt at injection site. No treatment was given for an AE. The patient sought medical attention via contacting pharmacist. At the time of the report the outcome of the events was unknown. Additional information is not expected.
Sex: U
Vaccine: VARCEL
Symptoms: Injection site erythema, Injection site pain, Injection site swelling
Clinical narrative: This spontaneous report as received from a registered nurse refers to 2 patients of age ranging from 9-18. The patients were vaccinated with VARIVAX (lot number reported as "0661AE", dose and duration not provided) on unknown dates "last month", in June 2012. No other co-suspects were reported. No concomitant medications were reported. On unknown dates the patients experienced injection site soreness, injection site swelling and injection site redness. The patients had sought medical attention via calling the office and were given BENADRYL and ice for the adverse events. None laboratory diagnostics studies were performed. The outcome the patients' adverse events were unknown. This is one of several reports received from the same source. Additional information has been requested.
Sex: U
Vaccine: VARCEL
Symptoms: Injection site erythema, Injection site pain, Injection site swelling
Clinical narrative: This spontaneous report as received from a registered nurse refers to 1-3 patients of age ranging from 9-18. The patients were vaccinated with VARIVAX (dose, duration and lot number not provided) on unknown dates "last month", in June 2012. No other co-suspects were reported. No concomitant medications were reported. Subsequently, the patients experienced severe local injection site reaction, reported as injection site soreness, injection site swelling and injection site redness. The patients had sought medical attention via calling the office and were given BENADRYL and ice for the adverse events. None laboratory diagnostics studies were performed. The outcome of the patients' adverse events were unknown. This is one of several reports received from the same source. Additional information has been requested.