chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Sex: U
Vaccine: VARZOS
Symptoms: Injection site rash, Rash vesicular
Clinical narrative: This spontaneous report was received from a nurse practitioner referring to an unknown gender and age patient with no pertinent medical history specified by the reporter. The reporter stated that on an unknown date, the patient received ZOSTAVAX vaccine (lot number and expiration date not reported) (dose, route and anatomical location not reported) at a pharmacy and at some point visited the physician's office. On an unknown date the patient developed a zoster type rash at the point of injection. The outcome of the zoster type rash at the point of injection was unknown at the time of the report. No treatment information was provided. Additional information is not expected.
Age: 56.0
Sex: F
Vaccine: TDAP
Symptoms: Injection site cellulitis, Injection site erythema, Injection site pain, Injection site warmth
Clinical narrative: Patient developed a localized red and warm area below the site of immunization measuring approximately 6 inches by 3 to 4 inches. Patient c/o pain at the injection site. Cellulitis evident. Pt started on cephalexin 500mg PO Q6 hours x 10 days.
Age: 44.0
Sex: M
Vaccine: SMALL, TYP
Symptoms: Headache, Injection site induration, Injection site swelling, Pain, Pyrexia
Clinical narrative: Swelling and firmness of the left bicep and upper arm. Extreme pain, accompanied 101 degree Fever. Bad headache.
Age: 47.0
Sex: F
Vaccine: PPV, TDAP
Symptoms: Blood glucose increased, Chest X-ray abnormal, Chest pain, Exostosis, Fluid overload
Clinical narrative: Onset of malaise day following vaccinations.  Nasal congestion, persistent nagging cough productive of greenish sputum, pleuritic chest pain, headache.  Unclear if fever d/t self-administered NSAIDs for headache.  Presence of one child with prolonged respiratory clinic on same date as patient vaccination visit.  Presented 3/25/13 with tachypnea, rhonchi on exam, +scattered (nonlobar) infiltrates on CXR.  Pulse ox 96% RA. Sugars 200s. PORT criteria OK for outpatient management.  Started on course of macrolide.  F/u pending. Had to defer planned airline flight.
Age: 47.0
Sex: F
Vaccine: PPV, TDAP
Symptoms: Headache, Lung infiltration, Malaise, Nasal congestion, Pneumonia
Clinical narrative: Onset of malaise day following vaccinations.  Nasal congestion, persistent nagging cough productive of greenish sputum, pleuritic chest pain, headache.  Unclear if fever d/t self-administered NSAIDs for headache.  Presence of one child with prolonged respiratory clinic on same date as patient vaccination visit.  Presented 3/25/13 with tachypnea, rhonchi on exam, +scattered (nonlobar) infiltrates on CXR.  Pulse ox 96% RA. Sugars 200s. PORT criteria OK for outpatient management.  Started on course of macrolide.  F/u pending. Had to defer planned airline flight.
Age: 47.0
Sex: F
Vaccine: PPV, TDAP
Symptoms: Productive cough, Rhonchi, Sputum discoloured, Tachypnoea
Clinical narrative: Onset of malaise day following vaccinations.  Nasal congestion, persistent nagging cough productive of greenish sputum, pleuritic chest pain, headache.  Unclear if fever d/t self-administered NSAIDs for headache.  Presence of one child with prolonged respiratory clinic on same date as patient vaccination visit.  Presented 3/25/13 with tachypnea, rhonchi on exam, +scattered (nonlobar) infiltrates on CXR.  Pulse ox 96% RA. Sugars 200s. PORT criteria OK for outpatient management.  Started on course of macrolide.  F/u pending. Had to defer planned airline flight.
Age: 26.0
Sex: F
Vaccine: TYP, YF
Symptoms: Headache, Injection site erythema, Injection site hypersensitivity
Clinical narrative: Mild headache, followed by the patient noticing a 1 inch diameter erythemic, mildly sensitive area at site of yellow fever injection, outer aspect left arm.
Age: 0.58
Sex: M
Vaccine: DTAPIPVHIB, PNC
Symptoms: Body temperature increased, Diarrhoea, Irritability
Clinical narrative: Extreme fussiness. 101.6 degree temperature 3/22/13, 3/23/13, 3/24/13. 99 degree temperature 3/25/13. Fussiness. Diarrhea 3/26/13.
Age: 74.0
Sex: F
Vaccine: VARZOS
Symptoms: Rash
Clinical narrative: Fine bumps and rash on hip and truck, and under arms. Skin now appears dry and improved. Information provided per caregiver.
Age: 34.0
Sex: M
Vaccine: ANTH
Symptoms: Arthralgia, Dizziness, Rash
Clinical narrative: Skin Rashes. Dizziness. Sore Joints.
Age: 11.0
Sex: F
Vaccine: HPV4
Symptoms: Abdominal pain upper, Gaze palsy, Immediate post-injection reaction, Incontinence, Loss of consciousness
Clinical narrative: Complaining her stomach hurt right after the Gardasil shot was administered then her face turned white she passed out her eyes rolled up into the back of her head her jaw was locked to the side she had incontinence at this time.
Age: 11.0
Sex: F
Vaccine: HPV4
Symptoms: Pallor, Trismus
Clinical narrative: Complaining her stomach hurt right after the Gardasil shot was administered then her face turned white she passed out her eyes rolled up into the back of her head her jaw was locked to the side she had incontinence at this time.
Age: 65.0
Sex: F
Vaccine: TDAP
Symptoms: Arthralgia, Arthritis, Joint stiffness
Clinical narrative: Joints, particularly knees, became inflamed, sore, and stiff.  Severe symptoms continued through to 03/24/2013 when all but the knee pain and inflammation diminished.  Knees are slowly improving but remain inflamed and painful through 03/26/2013.
Age: 39.0
Sex: F
Vaccine: PPV, TD
Symptoms: Body temperature increased, Oedema peripheral, Pain in extremity
Clinical narrative: Pt developed Temp of 102 and painful swelling in the arm.
Age: 10.0
Sex: F
Vaccine: HEPA, MNQ, TDAP
Symptoms: Injection site erythema, Injection site swelling, Injection site warmth
Clinical narrative: Slightly swollen red warm to touch left upper arm. Advised pain reliever BENADRYL; warm/cold compress, FU pvt MD.
Age: 1.23
Sex: M
Vaccine: FLU3
Symptoms: Computerised tomogram normal, Gastroenteritis, Intensive care, Laboratory test normal, Status epilepticus
Clinical narrative: Received #2 flu vaccine 12/12/12. 22 days later (1/3/13) status epilepticus, PICU (had gastroenteritis sx before admission). All evaluation negative (records included).
Age: 28.0
Sex: F
Vaccine: FLU3, TDAP
Symptoms: Body temperature increased, Feeling abnormal, Impaired work ability
Clinical narrative: Temperature of 103 degrees for 3 days. Stayed in bed. Took TYLENOL to keep temperature below 103 degrees when able to get out of bed. Missed 2 days of work. Felt "run-down" for next several days.
Age: 4.0
Sex: M
Vaccine: DTAPIPV, MMR, VARCEL
Symptoms: Rash generalised
Clinical narrative: Developed diffuse body rash on 3/17/13. Appeared worse on face.
Age: 2.0
Sex: F
Vaccine: DTAPHEPBIP, FLUN3, HIBV, MMR, PNC13, VARCEL
Symptoms: Foaming at mouth, Gaze palsy, Incontinence, Postictal state, Pyrexia
Clinical narrative: Fever onset a few hours after administration MOTRIN given. Next morning eyes rolled back, arms shaking, foaming at mouth, incontinent. EMS to ED. Episode last about 5 minutes. Post-ictal about 2 hours. Discharged home from ED same day.
Age: 2.0
Sex: F
Vaccine: DTAPHEPBIP, FLUN3, HIBV, MMR, PNC13, VARCEL
Symptoms: Tremor
Clinical narrative: Fever onset a few hours after administration MOTRIN given. Next morning eyes rolled back, arms shaking, foaming at mouth, incontinent. EMS to ED. Episode last about 5 minutes. Post-ictal about 2 hours. Discharged home from ED same day.
Age: 4.0
Sex: F
Vaccine: FLU3, MMR, PNC
Symptoms: Injection site bruising, Injection site erythema, Injection site warmth
Clinical narrative: Warm & redness at injection site of MMR (2-3 cm in diameter with slight bruising).
Age: 16.0
Sex: F
Vaccine: HPV4
Symptoms: Anogenital warts
Clinical narrative: Have never had any sexual partners until two months before receiving the three shot series. My self nor my partner was never diagnosed with genital warts until I received the second shot and they shortly appeared and had to receive treatment for them for six month for them to reside and my partner was not effected. So I would like some information because I have found some on the internet stating Gardasil can cause genital warts.
Age: 69.0
Sex: F
Vaccine: FLU3, VARZOS
Symptoms: Herpes zoster, Viral uveitis
Clinical narrative: Patient developed shingles of the forehead and eyelid about 11 days later with subsequent herpes zoster iritis.
Age: 0.16
Sex: F
Vaccine: DTAPHEPBIP, HIBV, PNC13, RV5
Symptoms: Auricular swelling, Pruritus, Rash, Scab
Clinical narrative: Grandparent states rash has developed with itching since receiving vaccine. States ear appears "thickened" and crusty. Notified HC on 3/26/13.
Age: 5.0
Sex: M
Vaccine: DTAP, IPV, MMRV
Symptoms: Injection site reaction, Rash vesicular, Varicella post vaccine
Clinical narrative: Chickenpox rash on back and left shoulder.
Age: 25.0
Sex: M
Vaccine: ANTH, MMR, SMALL, TYP
Symptoms: Antinuclear antibody negative, Full blood count, Laboratory test normal, Rash papular, Rash pruritic
Clinical narrative: Erythematous pruritic papules, nonblanchable on dorsal hands, elbows, knees. Slightly tender to the touch.
Age: 25.0
Sex: M
Vaccine: ANTH, MMR, SMALL, TYP
Symptoms: Red blood cell sedimentation rate increased, Tenderness
Clinical narrative: Erythematous pruritic papules, nonblanchable on dorsal hands, elbows, knees. Slightly tender to the touch.
Age: 65.0
Sex: F
Vaccine: VARZOS
Symptoms: Bursitis, Tendonitis
Clinical narrative: Bursitis and tendonitis in left shoulder area.  Diagnosed by doctor on 03/25/2013.  Ice, electric stimulation, chiropractic adjustment.
Age: 47.0
Sex: F
Vaccine: FLU3
Symptoms: Diarrhoea, Fatigue, Herpes zoster, Malaise, Pain in extremity
Clinical narrative: Vaccination was administered in left upper arm, 01/18/2013 pain in left arm and on left side, feeling of fatigue during the next few days, I got sick in the night from 01/25/2013 to 01/26/2013 - had diarrhea and had to throw up (at same time), mild diarrhea lasted for the better part of a week, had shingles the beginning of February, first symptoms around 02/01/2013, was treated with antivial drug (Zostex), visited Doctor 02/06/2013, started treatment with Zostex 02/06/2013.
Age: 47.0
Sex: F
Vaccine: FLU3
Symptoms: Vomiting
Clinical narrative: Vaccination was administered in left upper arm, 01/18/2013 pain in left arm and on left side, feeling of fatigue during the next few days, I got sick in the night from 01/25/2013 to 01/26/2013 - had diarrhea and had to throw up (at same time), mild diarrhea lasted for the better part of a week, had shingles the beginning of February, first symptoms around 02/01/2013, was treated with antivial drug (Zostex), visited Doctor 02/06/2013, started treatment with Zostex 02/06/2013.
Age: 60.0
Sex: F
Vaccine: VARZOS
Symptoms: Arthralgia, Blood test, Joint swelling, Nuclear magnetic resonance imaging
Clinical narrative: Severe pain and swelling in right knee.
Age: 4.0
Sex: M
Vaccine: DTAPIPV, MMRV
Symptoms: Injection site bruising, Injection site erythema, Pain
Clinical narrative: 1 cm raised, redness, bruised right deltoid, slight pain, WNL ROM. Advised warm/cold compress. Ibuprofen/Tylenol for pain. Return to clinic if worse.
Age: 64.0
Sex: F
Vaccine: VARZOS
Symptoms: Erythema, Headache, Injection site erythema, Injection site pruritus, Injection site rash
Clinical narrative: Small red rash at injection site measuring 1.5 inch by 1 inch with red, warm, itchy skin about 180 degrees around arm from injection site. Arm was very warm to touch. Possible fever with mild headache.
Age: 64.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site warmth, Pruritus, Skin warm
Clinical narrative: Small red rash at injection site measuring 1.5 inch by 1 inch with red, warm, itchy skin about 180 degrees around arm from injection site. Arm was very warm to touch. Possible fever with mild headache.
Age: 1.37
Sex: F
Vaccine: DTP, HEPA, HIBV, MMR
Symptoms: Pyrexia
Clinical narrative: Moderate fever.
Age: 65.0
Sex: F
Vaccine: PPV
Symptoms: Dizziness, Injection site erythema, Injection site oedema, Injection site pain, Joint range of motion decreased
Clinical narrative: Edema, erythema, pain, limited ROM in injected arm. Also with dizziness. Also with low grade fever. Treated with prednisone.
Age: 65.0
Sex: F
Vaccine: PPV
Symptoms: Pyrexia
Clinical narrative: Edema, erythema, pain, limited ROM in injected arm. Also with dizziness. Also with low grade fever. Treated with prednisone.
Age: 56.0
Sex: F
Vaccine: TDAP
Symptoms: Cellulitis
Clinical narrative: Cellulitis.
Age: 52.0
Sex: F
Vaccine: TDAP
Symptoms: Local swelling, Vascular test normal
Clinical narrative: (5) five days later, away from site, upper extremity swelling below biceps area down towards antecubital. Rx KEFLEX TID x 7 days.
Age: 4.0
Sex: M
Vaccine: DTAP, IPV, MMR, VARCEL
Symptoms: Injection site rash, Rash
Clinical narrative: Left thigh. Patchy rash at injection site on Lt ant thigh. Rx'd topical H.C. cream.
Age: 10.0
Sex: M
Vaccine: TDAP
Symptoms: Injection site erythema, Injection site induration, Injection site warmth, Local reaction, Oedema peripheral
Clinical narrative: Received Tdap vaccine 3/18/13, started having a local reaction 24 hours later = swelling to (L) arm with heat & redness at the site of injection & a hard induration measuring 12 cm x 9 cm. Parent instructed on care = cool compress, TYLENOL / MOTRIN for discomfort & BENADRYL if itch arises. Come in for visit if swelling increases.
Age: 69.0
Sex: F
Vaccine: PPV
Symptoms: Erythema, Immediate post-injection reaction, Pain in extremity, Urticaria
Clinical narrative: Immediately after the vaccination, I asked the pharmacist to test my blood pressure machine to see if it was working properly. He placed the blood pressure cuff on my left upper arm just below the vaccine site and he took my blood pressure. The next morning my upper arm began aching. That night there was a red streak on my upper arm. The next day (1/23) the redness had spread from upper arm to elbow. I saw my doctor and she said I had a huge hive and prescribed over the counter BENADRYL.
Sex: F
Vaccine: VARZOS
Symptoms: Rash
Clinical narrative: This spontaneous report was received from a Registered Nurse regarding her two sisters of unknown age. On an unspecified date a year ago (approximately in March 2012) the patients were vaccinated with ZOSTAVAX (lot number and expiration date not provided) (dose, and anatomical location not provided). No other co-suspects or concomitant medications were reported. The Nurse reported that on an unknown date her two sisters experienced a mild rash on their backs and shoulders after receiving ZOSTAVAX. Both patients were reported as recovered from the mild rash on their backs and shoulders. VZVIP Packet was not offered. No treatment information or laboratory diagnostic test results were reported. This is one of several reports from the same reporter (MARRS 1303USA009926). Additional information is not expected.
Sex: U
Vaccine: PPV
Symptoms: Adverse reaction
Clinical narrative: This spontaneous report as received from a licensed practical nurse on behalf of a doctor of osteopathy refers to unknown patient. The patients were vaccinated with PNEUMOVAX 23 on unknown dates. No other co-suspects were reported. No concomitant medications were reported. The patients experienced two reactions. At the time of reporting, the patient's outcome was unknown. Relatedness was not provided. This is one of several reports from the same source. Additional information has been requested. This is an amended report. Upon subsequent review, it was determined this case is a valid case; therefore, Non-valid has been removed from the case classification.
Age: 59.0
Sex: F
Vaccine: FLU3, PPV
Symptoms: Cellulitis, Erythema, Pruritus
Clinical narrative: Redness one day after vaccine administered, itching one week after vaccine administered. One week later developed a cellulitis in the same area.
Age: 1.29
Sex: F
Vaccine: DTAP
Symptoms: Induration, Injection site erythema, Injection site swelling
Clinical narrative: Swelling and red area on left leg. Small area of induration.
Age: 0.19
Sex: M
Vaccine: RV5
Symptoms: Lip blister
Clinical narrative: Patient was given oral vaccine of ROTATEQ. Within 10 minutes patient developed oral blister lesion on (Rt) side cheek/lower lip. Vital signs of patient were stable.
Age: 1.59
Sex: F
Vaccine: DTAP, HEPA, HIBV
Symptoms: Oedema peripheral, Rash, Urticaria
Clinical narrative: Patient developed hives to face, trunk, & extremities also swelling to hands and feet. Was given CLARITIN and CALADRYL was applied. Rash was on off and went away on 3-25-13.
Age: 47.0
Sex: M
Vaccine: DTP
Symptoms: Asthma, Condition aggravated, Cough
Clinical narrative: (L) upper arm vacc site. Asthma exac w/ST, cough, 3 days later. Per physician.
Age: 12.0
Sex: M
Vaccine: HPV4, MNQ, TDAP
Symptoms: Erythema, Pruritus, Rash, Swelling
Clinical narrative: Redness, swelling, rash and itchiness to Lt. arm.
Sex: F
Vaccine: HPV4
Symptoms: No therapeutic response
Clinical narrative: This spontaneous report as received from a physician, via a company representative, refers to young female patients of unknown age (no specific patient information was provided). On an unknown date the patients were vaccinated with GARDASIL. Dosing information, route of administration and lot numbers were not provided. The physician reported that she had not seen a decrease in LEEPS (loop electrosurgical excision procedures), colposcopies and positive PAP tests in young patients who had been given GARDASIL. Causality assessment was not provided. Additional information has been requested.
Age: 12.0
Sex: M
Vaccine: TDAP
Symptoms: Injection site cellulitis, Wrong technique in drug usage process
Clinical narrative: Per Dr., pt developed cellulitis after the Tdap vaccine at the injection site due to the "pharmacist's technique".
Age: 51.0
Sex: M
Vaccine: PPV
Symptoms: Injection site erythema, Injection site warmth
Clinical narrative: Left upper arm red & warm. Circumference measures 2 cm larger than unaffected arm. Redness extends 15 cm up from anti cubital. He received the shot on 3/25/13 at 315pm. States it began to throb last evening. Reported at 1100 on 3/26/13 with symptoms. Given BENADRYL 50 mg IM.
Age: 61.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site erythema, Injection site rash, Injection site swelling, Rash vesicular
Clinical narrative: This spontaneous report as received from a registered nurse refers to a 61 year old female patient with not known drug allergies and hypothyroidism. Past drug history was unknown. On 17-MAR-2013, the patient was vaccinated with ZOSTAVAX, 0.65 ml, subcutaneous injection in the left arm (lot # reported as 80211712, Exp. on 06-MAR/2014). Concomitant therapies included vitamins (unspecified) and AMBIEN. On the evening of 17-MAR-2013, the patient experienced redness at the injection site. On 19-MAR-2013, the patient experienced further redness and swelling at the injection site. She had was described as a vesicular rash which looks lie classic shingles just at the injection site. The patient relevant labs data was unknown. As of 19-MAR-2013, the patient no longer takes the ZOSTAVAX and continued to experience the redness, swelling and vesicular rash to the injection site. The outcome of redness at the injection site, swelling at the injection site and rash vesicular to the injection site was reported as not recovered. The causality for the event was unknown. Additional information is not expected.
Sex: U
Vaccine: VARCEL
Symptoms: Incorrect storage of drug
Clinical narrative: This spontaneous report as received from a registered nurse refers to an unknown number of patient who on an unknown date were vaccinated with (Merck) VARIVAX injection (strength, dose, route and frequency unspecified) (lot# and exp date were unspecified). The reported stated that on an unknown date, an unknown number of patients may have received improperly stored (Merck) VARIVAX. The doses of (Merck) VARIVAX were stored an average of -14C instead of -15C. Additional information has been requested.
Age: 63.0
Sex: M
Vaccine: PPV
Symptoms: Arthritis
Clinical narrative: This spontaneous report as received from purchasing agent refers to a 63 year old male patient with coronary disease, cirrhosis and hyperlipidemia and with none drug reactions or allergies. The patient's medical history included coronary artery bypass. The reporter stated that on 14-MAR-2013 the patient was vaccinated with PNEUMOVAX 23 (lot # H015749, expiration date 08-JUN-2014) single dose (dose and route unspecified). The purchasing agent reported that approximately in March 2013 the patient developed right arm localized arthritis after vaccination with PNEUMOVAX 23. At the time of the report the outcome of right arm localized arthritis after vaccination was unknown. The patient sought medical attention in physician's office on an unknown date. There were given prednisone (manufacturer unknown) and LORTAB as treatment. Additional information is not expected.
Age: 5.0
Sex: M
Vaccine: DTAPIPV
Symptoms: Injection site erythema, Injection site rash
Clinical narrative: Red rash over shoulder around injection site approximately 3 inches diameter. Non painful.
Age: 2.0
Sex: F
Vaccine: MMRV
Symptoms: Bacterial test positive, Rash, Rash generalised, Rash maculo-papular, Streptococcus test positive
Clinical narrative: On 2-22-13 pt received a PROQUAD vaccine; returned to clinic on 3-5-13 with complaint of rash; she had a fine maculopapular eruption all over, with no vesicular lesions.
Age: 2.0
Sex: F
Vaccine: MMRV
Symptoms: Vaccination complication
Clinical narrative: On 2-22-13 pt received a PROQUAD vaccine; returned to clinic on 3-5-13 with complaint of rash; she had a fine maculopapular eruption all over, with no vesicular lesions.
Age: 71.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site erythema, Injection site pruritus, Injection site swelling, Injection site warmth, Swelling
Clinical narrative: This spontaneous report as received from a 71 year old female consumer on herself with none pertinent medical history and non reaction/ allergies. On 14-MAR-2013 the patient was vaccinated with ZOSTAVAX (Lot # not provided) upper left arm (dose, route not reported). No other co suspects were reported. No concomitant therapy was reported. On 17-MAR-2013, the patient developed a big red,  hot, itchy 8 mm area at the injection site. The patient reported that a couple a days later, the area grew to 17 mm (1/2 dollar size) and was swollen down to her elbow and up to her armpit. The patient reported that went to urgent care and was prescribed BENADRYL, CORTIZONE (dose and manufacturer not specified). Labs diagnostics were not performed. The outcome of the patient had developed a big red at the injection site, was swollen down to her elbow and up to her armpit, itchy 8 mm area at the injection site and hot at the injection site was reported as recovering/resolving. Additional information has been requested.
Age: 1.53
Sex: F
Vaccine: RV5
Symptoms: Expired drug administered, No adverse event
Clinical narrative: This spontaneous report as received from a healthcare worker refers to a 16 month old female patient. On 18-MAR-2013 the patient was vaccinated with ROTATEQ (lot # 0543AA, expiration date 11-MAR-2013) third dose, 2 ml, oral. The reporter stated that on 18-MAR-2013, child was administered her third dose of ROTATEQ, but the ROTATEQ was expired. No adverse effects was reported. Additional information has been requested.
Age: 4.0
Sex: F
Vaccine: DTAPIPV, HEPA, MMR, PNC13, VARCEL
Symptoms: Body temperature increased, Pain in extremity
Clinical narrative: Pt woke this a.m. with temp of 101 degrees, both arms very sore. Mom, patient just wanted to tell HD and make sure everything ok. No nausea/vomiting, no rash.
Sex: F
Vaccine: HPV4
Symptoms: Dizziness, Viral infection
Clinical narrative: This spontaneous report was received from a Registered Nurse regarding an unknown age female patient with no pertinent medical history. In March 2013 (reported as about a week ago) the patient was vaccinated with the first dose in the series of GARDASIL (lot number and expiration date not reported) (dose, route and anatomical location not reported). On an unspecified date, 4 days after the vaccination with GARDASIL the patient began to experience recurrent episodes of dizziness, lasting 30 minutes to 1 hour. The outcome for the recurrent episodes of dizziness was reported as not recovered. The Nurse reported that the patient was seen by an Ear, Nose, and Throat physician, on an unspecified date due to the dizziness and was advised that she had an unspecified virus. No treatment information was reported. The patient sought medical attention by going to an Ear, Nose, and Throat physician. The reporter did not assess the causality between the recurrent episodes of dizziness and GARDASIL. Additional information has been requested.
Age: 66.0
Sex: M
Vaccine: VARZOS, VARZOS, VARZOS
Symptoms: Arthralgia, Injection site pain
Clinical narrative: Joint pain, muscle pain, felt cold, lethargic. Treatment with Ibuprofen & Tramadol.
Age: 66.0
Sex: M
Vaccine: VARZOS, VARZOS, VARZOS
Symptoms: Arthralgia, Muscular weakness, Myalgia, Pain in extremity
Clinical narrative: Joint pain, muscle pain, felt cold, lethargic. Treatment with Ibuprofen & Tramadol.
Age: 66.0
Sex: M
Vaccine: VARZOS, VARZOS, VARZOS
Symptoms: Arthralgia, Feeling cold, Lethargy, Myalgia
Clinical narrative: Joint pain, muscle pain, felt cold, lethargic. Treatment with Ibuprofen & Tramadol.
Age: 68.0
Sex: F
Vaccine: VARZOS
Symptoms: Erythema, Swelling
Clinical narrative: Redness, swelling.
Age: 62.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site erythema, Injection site inflammation, Injection site vesicles
Clinical narrative: Patient developed fluid filled blisters at site of injection, accompanied by redness and inflammation. See attached photos.
Age: 2.0
Sex: F
Vaccine: HEPA, MNQ
Symptoms: Loss of consciousness
Clinical narrative: Loss of consciousness for approximately 5 sec with quick recovery. Observed in clinic for 30 min with no farther reaction. BP checked and patient checked by MD. MD discussed with father -"syncope can happen after injection observe for recurring symptoms, call clinic promptly or call 911 with emergent concern at home". Taken from Dr's note on incident. Dad referred understanding.
Age: 42.0
Sex: F
Vaccine: TD
Symptoms: Dizziness, Nausea, Pruritus, Rash generalised, Vomiting
Clinical narrative: 1 hour after receiving injection, pt became dizzy, vomited, nauseated, rash on body itching.
Sex: U
Vaccine: VARZOS
Symptoms: Erythema, Swelling
Clinical narrative: This spontaneous report was received from a physician via a company representative refers to a patient of unknown age and gender. No medical history was reported. On an unknown date, the patient was vaccinated with a dose of ZOSTAVAX (lot#, dose and route not reported). No concomitant medications were reported. On an unknown date, the patient developed significant redness and swelling after receiving ZOSTAVAX. The patient sought medical attention (unspecified). The outcome of significant redness and swelling was reported as recovered. The relatedness for the events significant redness and swelling with ZOSTAVAX was unknown. Additional information has been requested.
Age: 0.34
Sex: F
Vaccine: DTAP, HIBV, IPV, PNC13, RV1
Symptoms: Blood culture negative, CSF culture negative, Computerised tomogram abnormal, Computerised tomogram head, Computerised tomogram head normal
Clinical narrative: Patient went to Med Ctr ER for generalized seizure lasting 10 min and 2 partial seizures lasting a few seconds on same day she received listed immunizations. Given 20 mg/kg PHENOBARBITONE at ER and placed on maintenance dose of 5 mg/kg/day for 30 days. F/U PCP 2d.
Age: 0.34
Sex: F
Vaccine: DTAP, HIBV, IPV, PNC13, RV1
Symptoms: Electroencephalogram normal, Mastoiditis, Nuclear magnetic resonance imaging brain normal, Otitis media, Partial seizures with secondary generalisation
Clinical narrative: Patient went to Med Ctr ER for generalized seizure lasting 10 min and 2 partial seizures lasting a few seconds on same day she received listed immunizations. Given 20 mg/kg PHENOBARBITONE at ER and placed on maintenance dose of 5 mg/kg/day for 30 days. F/U PCP 2d.
Age: 10.0
Sex: M
Vaccine: MNQ, TDAP, VARCEL
Symptoms: Injection site erythema, Injection site swelling, Injection site warmth
Clinical narrative: Red - warm - swelling left deltoid.
Age: 23.0
Sex: F
Vaccine: TDAP
Symptoms: Chills, Injection site swelling, Pain
Clinical narrative: Swelling at injection site, chills, body aches.
Age: 66.0
Sex: M
Vaccine: VARZOS
Symptoms: Blister, Ear pain, Hypersensitivity, Pain of skin, Pruritus
Clinical narrative: Hypersensitivity of scalp only on left side, with occasional pain, several small blisters on scalp behind left ear, itchy & occasionally painful, intermittent pain in left ear canal. Self-treated with ibuprofen for pain. Cleared up completely after 4 weeks.
Age: 76.0
Sex: F
Vaccine: PPV
Symptoms: Erythema, Oedema peripheral, Pruritus, Skin warm
Clinical narrative: Patient had her left arm swollen/red/warm to the touch from her elbow to her wrist. No reaction site of injection. Patient did not have any other symptoms. Reaction started about a day after her injection. She came to the pharmacy on the second day to help treat her condition and itchiness. Patient took OTC BENADRYL over the weekend and symptoms improved and disappeared per phone conversation 3/20/13.
Age: 1.15
Sex: F
Vaccine: MMR, PNC13, VARCEL
Symptoms: Febrile convulsion, Pyrexia
Clinical narrative: High fever '105' followed by febrile seizure.
Age: 0.17
Sex: F
Vaccine: DTAPIPVHIB, HEPA, PNC, RV1
Symptoms: No adverse event, Wrong drug administered
Clinical narrative: Hepatitis A was given instead of Hepatitis B. No side effects were reported. Pt was 2 months old.
Age: 0.33
Sex: F
Vaccine: DTAPHEPBIP, HIBV, PNC13, RV5
Symptoms: Drug administered to patient of inappropriate age, No adverse event
Clinical narrative: This spontaneous report as received from a registered nurse refers to a 20 week old patient (gender unspecified). The patient received the first dose of ROTATEQ on 20-MAR-2013 at 20 weeks of age. Lot# and administration route were unspecified. No adverse symptoms reported. It was unspecified if the patient sought medical attention or not. Additional information has been requested.
Sex: U
Vaccine: MMR, VARCEL
Symptoms: Inappropriate schedule of drug administration, No adverse event
Clinical narrative: This spontaneous report as received from a medical assistant refers to a patient of unknown age and gender. On an unspecified dates, the patient was vaccinated with a dose of MMR II (lot number, expiry date, route and dose were not reported) and a dose of (Merck) VARIVAX (lot number, expiry date, route and dose were not reported) one week apart and no adverse effect reported. Additional information has been requested.
Age: 57.0
Sex: F
Vaccine: VARZOS
Symptoms: Expired drug administered
Clinical narrative: This spontaneous report was received from a registered nurse refers to a 57 year old female patient. On 25-MAR-2013, the patient was vaccinated with an expired dose of ZSOTAVAX, (lot number reported as 0564AE, expiry date 21-MAR-2013, route was not reported). Concomitant medications were not reported. Additional information is not expected.
Age: 23.0
Sex: F
Vaccine: HPV4
Symptoms: Human papilloma virus test positive, Papilloma viral infection, Smear cervix abnormal
Clinical narrative: This spontaneous report was received from a nurse practitioner via company representative refers to a 23 year old female patient. On an unknown date, the patient was vaccinated with a dose of 0.5 ml GARDASIL, (lot number, expiry date was not reported and route was subcutaneous). Concomitant medications were not reported. On an unknown date in MAR-2013, the patient had a pap test which showed HPV positive (human papilloma virus). The patient has GARDASIL at the age of 14. The patient was at high risk. The nurse stated that they scheduling an endoscopy and looking into genotype tests. It was not clear if the patient had received the three vaccine dosages at the proper schedule. The outcome of the HPV positive was reported as not recovered. The patient did not seek medical attention. Additional information has been requested.
Age: 66.0
Sex: F
Vaccine: PPV
Symptoms: Body temperature increased, Fatigue, Injection site erythema, Injection site pain, Injection site swelling
Clinical narrative: This spontaneous report was received from a Licensed Practice Nurse refers to a 66 year old female patient. No medical history was reported. On 22-MAR-2013, the patient was vaccinated with a dose of 0.5 ml PNEUMOVAX 23 (lot # h015780, expiry: 11-JUN-2014) intramuscularly. No concomitant medications were reported. On 22-MAR-2013, 8 hours after injection the patient developed redness, pain and swelling at injection site, fever of 104F, fatigue, malaise and achiness. Patient was seen at the office and was given SOLUMEDROL and prednisone 20 mg tablets for 7 days and BENADRYL. There is no information as to whether these treatments relieved the symptoms. No laboratory tests were performed. The outcome of redness, pain and swelling at injection site, fever of 104F, fatigue, malaise and achiness was unknown. The relatedness of the events with PNEUMOVAX 23 was unknown. The nurse called because she is requesting to have a lot check done for PNEUMOVAX 23. This is 1 of 3 reports from the same source. Additional information has been requested.
Age: 66.0
Sex: F
Vaccine: PPV
Symptoms: Malaise, Pain, Pyrexia
Clinical narrative: This spontaneous report was received from a Licensed Practice Nurse refers to a 66 year old female patient. No medical history was reported. On 22-MAR-2013, the patient was vaccinated with a dose of 0.5 ml PNEUMOVAX 23 (lot # h015780, expiry: 11-JUN-2014) intramuscularly. No concomitant medications were reported. On 22-MAR-2013, 8 hours after injection the patient developed redness, pain and swelling at injection site, fever of 104F, fatigue, malaise and achiness. Patient was seen at the office and was given SOLUMEDROL and prednisone 20 mg tablets for 7 days and BENADRYL. There is no information as to whether these treatments relieved the symptoms. No laboratory tests were performed. The outcome of redness, pain and swelling at injection site, fever of 104F, fatigue, malaise and achiness was unknown. The relatedness of the events with PNEUMOVAX 23 was unknown. The nurse called because she is requesting to have a lot check done for PNEUMOVAX 23. This is 1 of 3 reports from the same source. Additional information has been requested.
Sex: F
Vaccine: HPV4
Symptoms: Inappropriate schedule of drug administration, No adverse event
Clinical narrative: This spontaneous report was received from a mother refers to her daughter of unknown age. On an unknown date in AUG-2012 the patient was vaccinated with first dose of GARDASIL, (lot number, expiry date and route was not reported). On an unknown date in JAN-2013, the patient was vaccinated with second dose of GARDASIL, (lot number, expiry date and route was not reported). On 25-MAR-2013, the patient was vaccinated with third dose of GARDASIL, (lot number, expiry date and route was not reported). Concomitant medications were not reported. The mother stated that though her daughter had received all the 3 doses of GARDASIL, but not at scheduled time. No adverse reactions were reported. Additional information has been requested.
Sex: F
Vaccine: PPV
Symptoms: Injection site erythema, Injection site swelling
Clinical narrative: This spontaneous report was received from a Licensed Practical Nurse refers to a female patient of unknown age and gender. No medical history was reported. On 19-MAR-2013, the patient was vaccinated with a dose of 0.5 ml PNEUMOVAX 23 (lot # h015780, expiry: 11-JUN-2014) intramuscularly. No concomitant medications were repotted. On 21-MAR-2013, the patient called the office because she had developed swelling and redness at injection site. No treatment was given. The outcome of swelling and redness at injection site was unknown. The relatedness of the events with PNEUMOVAX 23 was unknown. The nurse called because she is requesting to have a lot check done for PNEUMOVAX 23. This is 1 of 3 reports from the same source. Additional information has been requested.
Sex: U
Vaccine: PPV
Symptoms: Injection site erythema, Injection site swelling
Clinical narrative: This spontaneous report was received from a Licensed Practice Nurse refers to 3 to 5 patients of unknown age and gender. No medical history was reported. On an unknown date, the patients were vaccinated with a dose of 0.5 ml PNEUMOVAX 23 (lot # h015780, expiry: 11-JUN-2014) intramuscularly. No concomitant medications were reported. On an unknown date, the patients experienced swelling and redness at injection (reported as similar reactions to the related cases). The outcome of swelling of redness at injection site was unknown. The relatedness of the events with PNEUMOVAX 23 was unknown. The nurse called because she is requesting to have a lot check done for PNEUMOVAX 23. This is 1 of 3 reports from the same source. Additional information has been requested.
Sex: U
Vaccine: HPV4
Symptoms: Inappropriate schedule of drug administration, No adverse event
Clinical narrative: This spontaneous report was received from a medical assistant refers to a patient of unknown age and gender. No medical history was reported. On 10-JUN-2010, the patient was vaccinated with dose 1 GARDASIL (lot #, dose, route not reported). On 10-SEP-2010, the patient was vaccinated with dose 2 GARDASIL (lot #, dose, route not reported). On 12-OCT-2012, the patient was vaccinated with dose 3 GARDASIL (lot #, dose, route not reported). No concomitant medications were reported. No adverse symptoms reported. Additional information has been requested.
Sex: U
Vaccine: HPV4
Symptoms: Inappropriate schedule of drug administration, No adverse event
Clinical narrative: This spontaneous report was received from a physician assistant refers to a patient of unknown age. On 13-MAY-2009, the patient was vaccinated with a dose of GARDASIL, (lot number, expiry date and route was not reported). On 21-MAR-2013, the patient was vaccinated with another dose of GARDASIL, (lot number, expiry date and route was not reported). Concomitant mediations were not reported. No adverse effects were reported. Additional information has been requested.
Age: 14.0
Sex: F
Vaccine: HPV4
Symptoms: Inappropriate schedule of drug administration, No adverse event
Clinical narrative: This spontaneous report as received from a nurse practitioner refers to a patient of unknown age and demographics. The nurse practitioner reported that the patient was vaccinated with the first dose of GARDASIL in 2010 (exact date unspecified) and a second dose GARDASIL on 20-MAR-2013 (inappropriate schedule of drug administration). Patient route of administration and lot no. information were not provided. No adverse event was reported. Additional information has been requested.
Age: 66.0
Sex: U
Vaccine: PPV
Symptoms: Erythema, Injection site reaction, Oedema peripheral
Clinical narrative: This spontaneous report as received from a nurse practitioner refers to a 3 patients of unknown age and gender. On an unknown date, the patients were vaccinated with a dose of PNEUNOVAX 23 (lot # H013399, expiry date was 07-MAR-2014 and route was not reported) 0.5 milliliter (ml) in the ar. The nurse reported that at least 3 patients who were vaccinated with the same lot of PNEUMOVAX 23 developed huge injection site reaction, swelling at least 6 inches to include the whole upper arm and redness. The patients sought medical attention (office visit) and were prescribed steroids. The nurse also reported that she had not seen this type of reaction from PNEUMOVAX 23 before. The outcome of all the reported events was unknown. Additional information has been requested.
Age: 60.0
Sex: F
Vaccine: TDAP, VARZOS
Symptoms: Erythema, Injection site erythema, Injection site warmth, Paraesthesia, Skin warm
Clinical narrative: AREA AT INJECTION SITE STARTED TO GET RED AND WARM. NO ITCHING. WHEN SHE WAS SEEN BY US ON 3-26-13, THERE WAS AN APPROX 2 1/2CM INNER CIRCLE THAT WAS A DARKER RED AND AN APPROX 10CM OUTER CIRCLE THAT WAS IGHTER RED. WARM TO TOUCH AND SOME TNIGLING DOWN TOWARDS ELBOW.
Age: 27.0
Sex: F
Vaccine: YF
Symptoms: Arthralgia, Myalgia, Thirst
Clinical narrative: Excessive thirst, joint & muscle pain bilateral legs.
Age: 67.0
Sex: F
Vaccine: PPV
Symptoms: Erythema, Pain, Swelling
Clinical narrative: SHOOTING PAIN, REDNESS, SWELLING.
Age: 1.27
Sex: M
Vaccine: DTAP, HIBV, IPV, MMR
Symptoms: Rash generalised
Clinical narrative: Rash on cheek, then subsequently all over body in 12 hours.
Age: 19.0
Sex: F
Vaccine: PPV, TDAP
Symptoms: Injection site erythema, Injection site joint swelling, Pyrexia, Tachycardia, Tachypnoea
Clinical narrative: Tachypneic, tachycardic, febrile to 103. Right shoulder swollen and erythematous. Pt given Zosyn, vanc. ID consulted.
Age: 36.0
Sex: F
Vaccine: MMR
Symptoms: Arthralgia, Fatigue, Oropharyngeal pain, Swelling face
Clinical narrative: Fatigue, joint pain sore throat, next morning facial swelling.
Age: 0.17
Sex: F
Vaccine: DTAPHEPBIP, HIBV, PNC13
Symptoms: Immediate post-injection reaction, Urticaria
Clinical narrative: ** Within minutes of administering 2mo vaccines, infant broke out in raised, urticarial rash on legs only.  No distress or breathing difficulty.  1.25ml of Benadryl was given and infant was monitored in office for about 30 mins.  Rash started resolving prior to Benadryl and was almost completely gone at D/C. **
Sex: F
Vaccine: PPV, PPV
Symptoms: Phlebitis, Swelling
Clinical narrative: This spontaneous report as received from a pharmacist via a company representative refers to 4-5 patients seen in hospital obgyn (obstetrician/gynecologist) clinic who were of unknown age and gender. On an unknown date, the patients were vaccinated with a dose of PNEUMOVAX 23 (lot number, expiry date and route were not reported) 0.5 milliliter (ml) (reported as standard dose) in the leg. On an unknown date, the patients developed swelling and phlebitis. One of the patient had a reaction severe enough to seek attention in emergency room. It was unknown if the other patients sought medical attention or recovered treatment. The outcome of phlebitis and swelling was unknown. Additional information has been requested.
Sex: F
Vaccine: PPV, PPV
Symptoms: Abasia, Pain in extremity, Phlebitis, Swelling
Clinical narrative: This spontaneous report as received from a pharmacist via a company representative refers to 4-5 patients seen in hospital obgyn (obstetrician/gynecologist) clinic who were of unknown age and gender. On an unknown date, the patients were vaccinated with a dose of PNEUMOVAX 23 (lot number, expiry date and route were not reported) 0.5 milliliter (ml) (reported as standard dose) in the leg. On an unknown date, the patients developed swelling and phlebitis. One of the patient had a reaction severe enough to seek attention in emergency room. It was unknown if the other patients sought medical attention or recovered treatment. The outcome of phlebitis and swelling was unknown. Additional information has been requested.
Age: 14.0
Sex: M
Vaccine: VARZOS
Symptoms: No adverse event, Wrong drug administered
Clinical narrative: This spontaneous report as received from a medical assistant refers to a 14 year old male patient. On 22-MAR-2013, the patient was vaccinated with a dose of 0.5 ml ZOSTAVAX, (lot number reported as H014366, expiry date 06-NOV-2013, route was not reported) in place of the second dose of VARIVAX (Merck). Concomitant medications were not reported. No adverse event was reported. Additional information has been requested.
Sex: U
Vaccine: HPV4
Symptoms: Syncope
Clinical narrative: This spontaneous report was received from a physician via a company representative refers to a patient of unknown age and gender. No medical history was reported. On an unknown date, the patient was vaccinated with a standard dose of 0.5 ml of GARDASIL, (lot#, route  not reported). No concomitant medications were reported. On an unknown date, the patient experienced developing syncope months after receiving GARDASIL. The outcome of syncope was unknown. The relatedness for syncope with GARDASIL was unknown. Additional information is not expected.
Sex: F
Vaccine: VARZOS
Symptoms: Inflammation
Clinical narrative: This spontaneous report as received from a pharmacist refers to a female patient of unknown age. On 21-MAR-2013, the patient was vaccinated with a single dose of ZOSTAVAX (Lot number, expiry date and dose were not reported), subcutaneously. Approximately on an unknown date in March 2013, the patient experienced unspecified inflammation. The patient sought medical attention (details unspecified) for the same and was prescribed MEDROL dose pack. The outcome of unspecified inflammation was reported as not recovered/not resolved. Additional information is not expected.
Age: 0.4
Sex: F
Vaccine: DTAPHEPBIP, HIBV, PNC13, RV5
Symptoms: Urticaria
Clinical narrative: On 1/8/13 infant received vaccines. Shortly after mom noticed hives across arms & trunk. Went to ER & was treated with BENADRYL & TYLENOL. Symptoms resolved. F/U with MD, and she presents here today for 6mo vaccines with note from MD. To Whom it May Concern: This is to notify you that patient was seen in ER after her 2nd set of immunization for hives. As she was given injections of 5 different immunizations, it's best to give next set on individual injections at different days and DTaP to be administered last.
Age: 93.0
Sex: F
Vaccine: VARZOS
Symptoms: Burning sensation, Pain
Clinical narrative: This spontaneous report as received from a pharmacist via company representative refers to unspecified number of patients of unknown age and gender. On an unknown date, the patients were vaccinated with a dose of ZOSTAVAX (lot number reported as H021710, expiry date was 07-MAR-2014), 0.65 milliliter (reported as standard dose), subcutaneously. On an unspecified dates, more patients complained of burning and stinging with their current lot of ZOSTAVAX. No treatment was provided. The outcome of the reported event was unknown. Additional information has been requested.
Age: 17.0
Sex: F
Vaccine: HEPA, MNQ, VARCEL
Symptoms: Pruritus, Upper extremity mass
Clinical narrative: Pt's mother reported "golf-ball sized lump" on (R) arm, itchy, on 3/20/13. Denied heat/induration/redness/rash/hives/difficulty breathing or swallowing. Advised to give BENADRYL and/or ibuprofen if painful, bring by clinic to be assessed if mother prefers.
Sex: U
Vaccine: HPV4
Symptoms: Inappropriate schedule of drug administration, No adverse event
Clinical narrative: This spontaneous report as received from a nurse practitioner refers to a patient of unknown age (gender unspecified). It was reported that the patient was vaccinated with GARDASIL doses on the following dates: 19-DEC-2011 and 19-FEB-2013. Lot# and administration route was unspecified. No adverse effect reported. It was unspecified if the patient sought medical attention or not. Additional information has been requested.
Age: 60.0
Sex: M
Vaccine: VARZOS
Symptoms: Back pain, Blood test, Chest pain, Headache, Injection site erythema
Clinical narrative: Half-dollar size nodule under skin at injection site lasting one week. Tennis ball size redness around injection site lasting one week. Lethargic, body aches, headache lasting 3 days. Then neck pain starting lasting one week, then lower back pain lasting 1 - then severe thoracic pain started lasting 3 weeks.  Severe sore throat started on 3/11/2013 and continues with sinus congestion for past 16 days.
Age: 60.0
Sex: M
Vaccine: VARZOS
Symptoms: Injection site nodule, Lethargy, Neck pain, Oropharyngeal pain, Pain
Clinical narrative: Half-dollar size nodule under skin at injection site lasting one week. Tennis ball size redness around injection site lasting one week. Lethargic, body aches, headache lasting 3 days. Then neck pain starting lasting one week, then lower back pain lasting 1 - then severe thoracic pain started lasting 3 weeks.  Severe sore throat started on 3/11/2013 and continues with sinus congestion for past 16 days.
Age: 60.0
Sex: M
Vaccine: VARZOS
Symptoms: Sinus congestion
Clinical narrative: Half-dollar size nodule under skin at injection site lasting one week. Tennis ball size redness around injection site lasting one week. Lethargic, body aches, headache lasting 3 days. Then neck pain starting lasting one week, then lower back pain lasting 1 - then severe thoracic pain started lasting 3 weeks.  Severe sore throat started on 3/11/2013 and continues with sinus congestion for past 16 days.