chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 65.0
Sex: F
Vaccine: PPV
Symptoms: Feeling hot, Induration, Mobility decreased, Nodule, Swelling
Clinical narrative: Pneumococcal polysaccharide vaccine. Swelling, heat, hard knot, pain, couldn't lift arm to shoulder level. The swelling was from injection site-left side, down arm, just above elbow and up to shoulder to clavicle. Treatment: cold compresses & ibuprofen.
Age: 16.0
Sex: M
Vaccine: MNQ, VARCEL, MNQ, VARCEL
Symptoms: Abasia, Convulsion, Walking aid user
Clinical narrative: Per mom pt exhibited "convulsions" that night.  (Exact time unknowns.)  Had to be physically carried to the car as she could not walk.  Taken to ED.
Age: 16.0
Sex: M
Vaccine: MNQ, VARCEL, MNQ, VARCEL
Symptoms: Abasia, Headache, Hyperhidrosis, Muscle spasms, Pain in extremity
Clinical narrative: Per mom pt exhibited "convulsions" that night.  (Exact time unknowns.)  Had to be physically carried to the car as she could not walk.  Taken to ED.
Age: 16.0
Sex: M
Vaccine: MNQ, VARCEL, MNQ, VARCEL
Symptoms: Tremor, Walking aid user
Clinical narrative: Per mom pt exhibited "convulsions" that night.  (Exact time unknowns.)  Had to be physically carried to the car as she could not walk.  Taken to ED.
Age: 0.16
Sex: F
Vaccine: DTAPHEPBIP
Symptoms: Apnoea, Endotracheal intubation, Full blood count normal, Mechanical ventilation, Staphylococcus test positive
Clinical narrative: Significant apnea eventually requiring intubation and mechanical ventilation.
Age: 50.0
Sex: F
Vaccine: DT
Symptoms: Injection site inflammation, Injection site swelling, Wrong drug administered
Clinical narrative: On 8/11/2014 Employee's forearm had a raised bump with inflammation surrounding area.  Area spread as each day passed.
Age: 61.0
Sex: M
Vaccine: VARZOS
Symptoms: Injection site erythema, Injection site pain, Injection site pruritus, Injection site swelling
Clinical narrative: Redness, soreness, swelling and itching at the injection site.  No treatment.  Having the same symptoms today (8/14) and has not lessened from yesterday (8/13).
Age: 0.17
Sex: F
Vaccine: DTAPIPVHIB, HEP, PNC13, RV5
Symptoms: Haematochezia, Occult blood positive
Clinical narrative: Bloody stool w/Positive Guiac Card.
Age: 83.0
Sex: F
Vaccine: VARZOS
Symptoms: Erythema, Pruritus
Clinical narrative: 8/13/14 - patient noticed small area of redness and only a slight, rare itchiness. 8/14/14 pt. noticed increased area of redness. 8/14/14 12pm patient came to pharmacy - pharmacist measured a red area 3" wide 4" long - not raised.
Age: 16.0
Sex: F
Vaccine: MNQ
Symptoms: Erythema, Skin warm, Swelling
Clinical narrative: After vaccine given, some swelling after (same) day. Swelling increased daily after injection. Today is red, warm and measures 10cm x 9cm (L) arm.
Age: 65.0
Sex: F
Vaccine: PPV
Symptoms: Chills, Injection site rash, Pain, Pain in extremity, Pyrexia
Clinical narrative: Fever, body aches, chills, rash at site of injection, arm pain.
Age: 11.0
Sex: U
Vaccine: HPV4
Symptoms: Syncope
Clinical narrative: This spontaneous report was received from a Company Representative refers to a 11 year old patient. On an unknown date the patient was vaccinated with GARDASIL, intramuscular. On an unknown date this week the patient fainted after received the 1st dose of GARDASIL. The outcome of the patient fainting after receiving the 1st dose of GARDASIL is unknown. Some of the fields in the AE are marked, "Unspecified by Reporter", because the representative did not have specific information. Additional information is  not expected.
Age: 11.0
Sex: M
Vaccine: MNQ, TDAP
Symptoms: Computerised tomogram head normal, Dizziness, Full blood count normal, Headache, Migraine
Clinical narrative: OV on 7/22/14 for c/o HA, blurring of vision, vertigo and ringing in ears x5 days. BP was 98/64. Dx with viral illness but given eye appt. Seen by optometrist on 7/24/14. Dx with (R) optic nerve elevation and swelling. Referred to neuro. ophthalmologist. OV on 7/25/14 ongoing HA, dizzy, blurred vision, improving but still present. 7/26/14 seen in ER with increased HA, blurry vision. Dx with sinusitis and likely complex migraine. Referred to neuro. 7/28/14 normal exam with neuro. ophthalmology. Also saw neuro. on 7/28/14 - no report yet. 8/5/14 OV vision better, still "not himself" per mom.
Age: 11.0
Sex: M
Vaccine: MNQ, TDAP
Symptoms: Papilloedema, Sinusitis, Tinnitus, Vertigo, Viral infection
Clinical narrative: OV on 7/22/14 for c/o HA, blurring of vision, vertigo and ringing in ears x5 days. BP was 98/64. Dx with viral illness but given eye appt. Seen by optometrist on 7/24/14. Dx with (R) optic nerve elevation and swelling. Referred to neuro. ophthalmologist. OV on 7/25/14 ongoing HA, dizzy, blurred vision, improving but still present. 7/26/14 seen in ER with increased HA, blurry vision. Dx with sinusitis and likely complex migraine. Referred to neuro. 7/28/14 normal exam with neuro. ophthalmology. Also saw neuro. on 7/28/14 - no report yet. 8/5/14 OV vision better, still "not himself" per mom.
Age: 11.0
Sex: M
Vaccine: MNQ, TDAP
Symptoms: Vision blurred
Clinical narrative: OV on 7/22/14 for c/o HA, blurring of vision, vertigo and ringing in ears x5 days. BP was 98/64. Dx with viral illness but given eye appt. Seen by optometrist on 7/24/14. Dx with (R) optic nerve elevation and swelling. Referred to neuro. ophthalmologist. OV on 7/25/14 ongoing HA, dizzy, blurred vision, improving but still present. 7/26/14 seen in ER with increased HA, blurry vision. Dx with sinusitis and likely complex migraine. Referred to neuro. 7/28/14 normal exam with neuro. ophthalmology. Also saw neuro. on 7/28/14 - no report yet. 8/5/14 OV vision better, still "not himself" per mom.
Age: 5.0
Sex: F
Vaccine: DTAPIPV, MMR, VARCEL
Symptoms: Injection site erythema, Injection site swelling, Injection site warmth
Clinical narrative: Large softball sized red, raised area at injection site. Hot to touch.
Age: 53.0
Sex: F
Vaccine: DT
Symptoms: Injection site erythema, Injection site inflammation, Injection site swelling
Clinical narrative: Red inflammed left forearm with slight red bump where the needle administered the medication.
Age: 5.0
Sex: F
Vaccine: DTAPIPV, MMR, VARCEL
Symptoms: Dizziness, Heart rate decreased, Hyperhidrosis, Oxygen saturation decreased, Pallor
Clinical narrative: Child had syncopal episode, pt complained of feeling dizzy and then fainted in mom's arms.  Upon placing an oximeter on the child oxygen sat was 96% and heart rate was 43.  Child was alert and complained of being dizzy, however appeared pale and diaphoretic.  Apical pulse was 52.  I left to call doctor and two other nurses stayed with pt, while I was gone oxygen dropped to 83% and heart rate 62.  Physician stated for her to come to his office.
Age: 5.0
Sex: F
Vaccine: DTAPIPV, MMR, VARCEL
Symptoms: Syncope
Clinical narrative: Child had syncopal episode, pt complained of feeling dizzy and then fainted in mom's arms.  Upon placing an oximeter on the child oxygen sat was 96% and heart rate was 43.  Child was alert and complained of being dizzy, however appeared pale and diaphoretic.  Apical pulse was 52.  I left to call doctor and two other nurses stayed with pt, while I was gone oxygen dropped to 83% and heart rate 62.  Physician stated for her to come to his office.
Age: 0.59
Sex: M
Vaccine: DTAPIPVHIB
Symptoms: Unevaluable event
Clinical narrative: None.
Sex: U
Vaccine: MMRV
Symptoms: Expired drug administered, No adverse event
Clinical narrative: This spontaneous report as received from a physician refers to a patient of unknown age and gender. The patient's pertinent medical history, drug reactions/allergies were not provided. On 12-AUG-2014, the patient was vaccinated with a dose of PROQUAD, 0.5ml subcutaneous, lot # J001011, which expired on 26-JUN-2014. No adverse effects were reported. Additional information has been requested.
Age: 67.0
Sex: M
Vaccine: TDAP
Symptoms: Rash, Skin lesion
Clinical narrative: Skin rash and skin lesion on upper extremity. Prednisone 5 mg every day, Ammonium lactate 12% ml BID.
Age: 41.0
Sex: M
Vaccine: DTP, MNQ
Symptoms: Chest discomfort, Dyspnoea, Hyperhidrosis, Tinnitus
Clinical narrative: About 5-10 minutes after receiving injections, patient complained of diaphoresis, difficulty breathing, ears ringing, and chest tightening. Provider came to bedside and a stat page was called. Patient was placed in a Trendelenburg and feet were raised. Patient started to come to and stated that he was ok. He was able to give his name, date of birth, and identify where he was. He said he breathing and chest were better. Patient was able to stand up with no difficulties and was coherent. Patient was discharged.
Sex: M
Vaccine: VARZOS
Symptoms: Hangover, Headache, Tinnitus
Clinical narrative: This spontaneous report was received from a male patient of unknown age reporting on himself without medical history, drug reactions and allergies. On an unknown date the patient was vaccinated with ZOSTAVAX lot # J013451, Expiration ate: 25-JAN-2015, 0.65 ml in the back of the upper arm for prevention of shingles (route of administration was not reported). There was not concomitant medication. Couple of months ago the patient developed headache and ringing in the ear late the day or the next day he received ZOSTAVAX. He reported that it felt like a hangover. Patient did not receive any treatment for the adverse event. He did not seek medical attention. There were not laboratories diagnostics studies performed. The outcome of the events was reported as not recovered/not resolved. Additional information has been requested.
Age: 10.0
Sex: M
Vaccine: HPV4, TDAP
Symptoms: Nausea, Vomiting
Clinical narrative: Nausea and vomiting x 1. Resolved.
Age: 19.0
Sex: M
Vaccine: TDAP
Symptoms: Fatigue, Pain, Pyrexia
Clinical narrative: Student received Tdap, later in day felt tired, had body aches and ran a fever of 102 degrees. The next morning he returned to clinic.  He was seen by a nurse practitioner at 923 AM.  His fever had dropped to 99.2 without intervention.  He was discharged with instructions to use Tylenol for fever.  Discussed side effects of vaccine and told to return to clinic if any further reaction.
Age: 11.0
Sex: M
Vaccine: HEPA, IPV, MMRV, MNQ, TDAP
Symptoms: Injection site pain, Injection site swelling
Clinical narrative: 08/13/2014 Mother states when she came home from work she noticed swelling on the left arm around injection site, approximately the size of a nickel. Mother gave child Benadryl @ 2pm and again at 8pm. On 08/14/2014, Mother at lunch time reported swelling had increased to greater than approximately 2 inches. Child states that it stings to touch and when bathing with soap.
Age: 4.0
Sex: U
Vaccine: MMRV
Symptoms: Incorrect storage of drug, No adverse event
Clinical narrative: This spontaneous report as received from a medical assistant refers to a 4 year old patient who on 18-JUN-2014, was vaccinated with a dose of (Oka/Merck) PROQUAD (lot number K005648, Exp. Date: 17-OCT-2015) (dose and route not reported) that was improperly stored. No adverse effects were reported. This is one of several reports from the same source. Additional information has been requested.
Age: 4.0
Sex: U
Vaccine: MMRV
Symptoms: Incorrect storage of drug, No adverse event
Clinical narrative: This spontaneous report as received from a medical assistant refers to a 4 year old patient who on 24-JUL-2014, was vaccinated with a dose of (Oka/Merck) PROQUAD (lot number K005648, Exp. Date: 17-OCT-2015)(dose and route not reported) that ws improperly stored. No adverse effects were reported. This is one of several 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 as received from a pharmacist refers to a patient of unknown age and gender. Pharmacist reported that the patient was in office to receive a third dose of GARDASIL (lot# and expiration date not provided) (dose: 0.5ml), intramuscularly and it had been approximately one year, since the patient had received the second dose of GARDASIL  (lot# and expiration date not provided) (dose not reported). No adverse effect was reported. Additional information has been requested.
Sex: U
Vaccine: PPV
Symptoms: No adverse event, Wrong drug administered
Clinical narrative: This spontaneous report was received from a health care worker refers to a patient of unknown age and gender. On an unknown date the patient was vaccinated with PNEUMOVAX 23 (dose, lot # and route of administration were not reported). The reported stated that the patient received 3 doses of PREVNAR and then 1 dose of PNEUMOVAX 23, instead of a 4th dose of PREVNAR, by mistake. No adverse effects reported. Additional information has been requested.
Sex: U
Vaccine: HPV4
Symptoms: Inappropriate schedule of drug administration, No adverse event
Clinical narrative: This spontaneous report sa received from a licensed practical nurse refers to a patient of unknown age and gender. The patient's pertinent medical history, drug reactions/allergies were not provided. It was reported that in June 2010, the patient received the first dose of GARDASIL, intramuscular (lot number and expiration date were not provided) and in August 2011, the patient received the second dose of GARDASIL, intramuscular (lot number and expiration date were not provided). Co-suspect therapy and concomitant medications were not provided. No adverse effects were reported. Additional information has been requested.
Age: 11.0
Sex: F
Vaccine: HPV4, MNQ
Symptoms: Dizziness
Clinical narrative: Patient felt dizzy 5-10 minutes after receiving HPV vaccine.
Age: 14.0
Sex: U
Vaccine: MMR, VARCEL
Symptoms: Incorrect storage of drug, No adverse event
Clinical narrative: This spontaneous report as received from a medical assistant refers to a 14 year old patient who on 09-JUL-2014, the patient was vaccinated with a dose of (Oka/Merck) Varivax (lot numbers reported as J012816, Exp. Date: 10-OCT-2015 and J009986, Exp. Date: 12-AUG-2015) .5 ml, subcutaneous and a dose of M-M-R II HSA (lot numbers reported as J002866, Exp. Date: 12-MAR-2015 and J008154 Exp. Date: 08-JUL-2015) that were improperly stored. Doses and routes were not reported. No adverse effects were reported. This is one of several reports from the same source. Additional information has been requested.
Age: 14.0
Sex: U
Vaccine: MMR, VARCEL
Symptoms: Incorrect storage of drug, No adverse event
Clinical narrative: This spontaneous report as received from a medical assistant concerning 14 year old patient who on 25-JUN-2014, the patient was vaccinated with a dose of MMR II (lot numbers reported as J002866, Exp. Date: 12-MAR-2015 and J008154, Exp. Date: 08-JUL-2015) and (Oka/Merck) VARIVAX (lot numbers reported as J009986, Exp. Date: 12-AUG-2015 and J012816, Exp. Date: 10-OCT-2015) that were improperly stored. Doses and routes were not reported. No adverse effects were reported. This is one of several repots from the same source. Additional information has been requested.
Age: 4.0
Sex: U
Vaccine: MMR
Symptoms: Incorrect storage of drug, No adverse event
Clinical narrative: This spontaneous report as received from a medical assistant refers to a 4 year old patient who on 16-JUL-2014, was vaccinated with a dose of M-M-R II HSA (lot number reported as J002866, Exp. Date: 12-MAR-2015 and J008154, Exp. Date: 08-JUL-2015) that was improperly stored. Dose and route not reported. No adverse effects were reported. This is one of several reports from the same source. Additional information has been requested.
Age: 83.0
Sex: F
Vaccine: VARZOS
Symptoms: Asthenia, Headache, Incorrect dose administered, Neuropathy peripheral, Paraesthesia
Clinical narrative: This spontaneous report as received from a consumer (patient's husband) refers to a 83 year old female patient with no drug reactions or allergies and with no medical history. On 15-MAY-2009, the patient received the first dose of ZOSTAVAX and on 19-MAY-2014, the patient was inadvertently administered the second dose of ZOSTAVAX injected in the arm (dose, route of administration, indication, lot# and expiry date unspecified). No concomitant medications were taken. Approximately in June 2014 (reported as "about 2 weeks later"), the patient started experiencing tingling feeling in her legs, headache and weakness. The patient's husband further explained that the patient sought medical attention and was seen by several physicians including a Neurosurgeon and Neurologist (all unspecified) and had been prescribed medications: levothyroxine, duloxetine and ATIVAN, however nothing had helped. The reported also stated his wife had to visit 2 different local emergency rooms 3 different times (dates unspecified) for treatment of her symptoms, but was never admitted. The patient had several diagnostic tests performed: magnetic resonance imaging (MRI), glucose intolerance and various unspecified tests, but no results were provided. The patient's husband also stated that at some point, on an unspecified date, his wife was diagnosed with neuropathy. The outcome of the events was reported as not recovered. The relatedness between the events and ZOSTAVAX was not reported. Additional information has been requested.
Age: 22.0
Sex: F
Vaccine: HPV4
Symptoms: Inappropriate schedule of drug administration, No adverse event
Clinical narrative: This spontaneous report was received from a nurse refers to a 22 year old female patient. On 08-AUG-2014 the patient was vaccinated with GARDASIL dose 2, 0.5ml, intramuscular in the patient's left arm (lot # was not reported). It was reported that the patient got her first dose of GARDASIL on 08-AUG-2013 and the second dose, one year after she received the first dose GARDASIL. No adverse effects were reported. Additional information is not expected due to the reporter did not want to be contacted again.
Age: 0.34
Sex: F
Vaccine: DTAPIPVHIB, PNC13, RV5, RV5
Symptoms: Abdominal X-ray, Culture stool, Diarrhoea, Diarrhoea haemorrhagic, Full blood count
Clinical narrative: 8-12-14 ROTATEQ given, that evening child developed fever and diarrhea per mom. 8-13-14 childs diarrhea continued, blood in stools developed, called office, given temp 102.8, bloody diarrhea
Age: 0.34
Sex: F
Vaccine: DTAPIPVHIB, PNC13, RV5, RV5
Symptoms: Haematochezia, Occult blood, Pyrexia
Clinical narrative: 8-12-14 ROTATEQ given, that evening child developed fever and diarrhea per mom. 8-13-14 childs diarrhea continued, blood in stools developed, called office, given temp 102.8, bloody diarrhea
Age: 0.34
Sex: F
Vaccine: DTAPIPVHIB, PNC13, RV5, RV5
Symptoms: Abdominal X-ray, Culture stool, Diarrhoea, Full blood count, Haematochezia
Clinical narrative: 8-12-14 ROTATEQ given, that evening child developed fever and diarrhea per mom. 8-13-14 childs diarrhea continued, blood in stools developed, called office, given temp 102.8, bloody diarrhea
Age: 0.34
Sex: F
Vaccine: DTAPIPVHIB, PNC13, RV5, RV5
Symptoms: Occult blood, Pyrexia
Clinical narrative: 8-12-14 ROTATEQ given, that evening child developed fever and diarrhea per mom. 8-13-14 childs diarrhea continued, blood in stools developed, called office, given temp 102.8, bloody diarrhea
Age: 4.0
Sex: M
Vaccine: DTAPIPV, MMR, VARCEL
Symptoms: Erythema, Oedema, Skin warm
Clinical narrative: Redness, warm to touch, slight edema. Ice packs, ibuprofen, RTO in 2 wks per dr.
Age: 19.0
Sex: F
Vaccine: MNQ, TDAP
Symptoms: Discomfort, Injection site pain, Local swelling, Pain, Skin warm
Clinical narrative: Body Aches, soreness at site of injection, swelling at 10mm, warm, hot to touch. Student didn't return to clinic.  Notified clinic when she returned 3 days later for another appointment. No longer had discomfort. small swollen area 3-5mm jus below site. No discomfort.
Age: 21.0
Sex: F
Vaccine: HPV4
Symptoms: Inappropriate schedule of drug administration, No adverse event
Clinical narrative: This spontaneous report was received from a physician refers to a 21 years old female patient. On 08-JUL-2014 the patient was vaccinated with GARDASIL dose 2, 0.5ml, intramuscular in the patient's left deltoid (lot# was not reported). It was reported that the patient got her first dose of GARDASIL in August 2012. Third dose had not been administered at the time of this report. No adverse effects were reported. Additional information has been requested.
Age: 14.0
Sex: U
Vaccine: MMR, VARCEL
Symptoms: Incorrect storage of drug, No adverse event
Clinical narrative: This spontaneous report as received from a medical assistant refers to a 14 year old patient who on 15-JUL-2014, the patient was vaccinated with a dose of (Oka/Merck) VARIVAX (lot numbers reported as J012816, Exp. Date: 10-OCT-2015 and J009986, Exp. Date: 12-AUG-2015) .5 ml, subcutaneous and a dose of MMR II (lot numbers reported as J002866, Exp. Date: 12-MAR-2015 and J008154 Exp. Date: 08-JUL-2015) that were improperly stored. Doses and routes were not reported. No adverse effects were reported. This is one of several reports from the same source. Additional information has been requested.
Sex: F
Vaccine: VARZOS
Symptoms: Injection site vesicles
Clinical narrative: This spontaneous report as received from a physician refers to a female patient in her 60's. The patient's pertinent medical history, drug reactions/allergies were not provided. On 07-AUG-2014, the patient was vaccinated with a dose of ZOSTAVAX, (route, lot number and expiration date were not provided). Co-suspect therapy and concomitant medications were not provided. It was reported that in August 2014, after receipt vaccin, the patient experienced vesicles at the injection site. One vesicle, at the injection site, was the size of a silver dollar and there were several smaller vesicles around the injection site. Patient had no generalized symptoms or malaise. The patient was prescribed antivirals as treatment. The patient sought medical attention buy seeing the physician. At the time of the report, the patient's outcome was unknown and the relatedness between the events and suspect therapy was not provided. Additional information has been requested.
Sex: U
Vaccine: MMRV
Symptoms: Incorrect storage of drug, No adverse event
Clinical narrative: This spontaneous report as received from a registered nurse refers to an unknown number of patients of unknown age and unknown gender. Pertinent medical history, drug reactions or allergies were not reported. On unspecified dates, the unknown number of patients were inadvertently administered (Oka/Merck) PROQUAD, that had been improperly stored (strength, dose, dose schedule, route, anatomical location, lot number and expiration date were unspecified). No concomitant therapies were reported. No adverse effects reported. The outcome of inadvertently administered (Oka/Merck) PROQUAD that had been improperly stored was unknown. Additional information has been requested.
Sex: U
Vaccine: MMRV
Symptoms: Incorrect storage of drug, No adverse event
Clinical narrative: This spontaneous report as received from a Licensed Practical Nurse refers to unspecified patients of unknown age and gender. The nurse reported that on an unknown date these unspecified patients received improperly stored (Oka/Merck) VARIVAX (captured in MARRS#1408USA008605) and measles virus vaccine live (Enders-Edmonston), mumps virus vaccine live (Jeryl Lynn), rubella virus vaccine live (Wistar RA 27/3), (Oka/Merck) PROQUAD lot # reported as K003821 with exp date of 14-SEP-2015 and lot # K004713 exp date 02-OCT-2015, dose strength, site of administration not reported, which were exposed to a maximum temperature of -9C on multiple occasions, for undetermined timeframe (also reported that both vaccines were exposed to only -8.9C for only 15 hours). No adverse effects were reported. No Product Quality Complaint (PQC) reported. This is one of several reports received from the same reporter. Additional information has been requested.
Sex: U
Vaccine: VARZOS
Symptoms: Herpes zoster
Clinical narrative: This spontaneous report as received from a healthcare worker/pharmacy intern refers to a patient of unknown age. Recently(actual date unspecified) the patient was vaccinated with a dose of ZOSTAVAX (0.65 ml, subcutaneous). On 01-AUG-2014 (reported as within the last ten days) the patient experienced shingles. The patient was screened for contraindications and the reporter states, "they would not have vaccinated if there were any concerns." The patient had contact pharmacy medical attention. The outcome of shingles was unknown. The causality was not reported. Additional information has been requested.
Sex: U
Vaccine: PPV
Symptoms: Expired drug administered, No adverse event
Clinical narrative: This spontaneous report as received from a healthcare worker (also reported as medical assistant) refers to a patient of unknown age and gender. On 07-AUG-2014, the patient was inadvertently vaccinated with the first dose of PNEUMOVAX23, injection, 0.5 ml, one time dose, intramuscular, (lot # H020684) that expired in April 2014. No concomitant therapy was reported. No adverse experience. Additional information has been requested.
Age: 4.0
Sex: F
Vaccine: DTAP, IPV, MMR, VARZOS
Symptoms: Gait disturbance, Injection site swelling, Wrong drug administered
Clinical narrative: This spontaneous report as received from a physician assistant refers to a 4 year old female patient with no pertinent medical history or drug reactions/allergies. On 05-AUG-2014 the patient was accidentally vaccinated with a dose of ZOSTAVAX (0.65ml, subcutaneously) (lot # J014809, expired date, 20-FEB-2015) instead of VARIVAX (Merck). On the same visit, the patient also vaccinated with M-M-R II (dosage information unknown), DTaP and IPV (unspecified). On 06-AUG-2014, the patient experienced swelling of unspecified leg and the swollen leg was hard to walk on. No treatment was given to the events. No lab diagnostics studies performed. The patient's mother called the physician assistant for medical attention on 06-AUG-2014. At the time of the report, the patient was not recovered. The causality was not provided. Additional information has been requested.
Age: 19.0
Sex: F
Vaccine: HPV4
Symptoms: Menstruation delayed
Clinical narrative: This spontaneous report as received from a physician refers to a 19 year old female patient with no pertinent medical history or drug reactions/allergies. In approximately July 2014 ("last month") the patient was vaccinated with first dose of GARDASIL lot #, expiration date not reported, 0.5 ml, intramuscular. There was no concomitant medication. The patient's mother called the office and was very upset because the patient had not had her period for one month after the first dose of GARDASIL and had not had her period at the time  of the call. There was no treatment given for the event. No lab diagnostics studies performed. The outcome of the event was reported as not recovered. This is one of the report from the same source. Additional information has been requested.
Sex: U
Vaccine: MMR
Symptoms: Antibody test negative, Inappropriate schedule of drug administration, No adverse event
Clinical narrative: This spontaneous report as received from a nurse refers to a various unspecified patients of unknown age. The patients drug allergies and concomitant medications were not reported. On an unknown date, the various unspecified patients were vaccinated with some form of M-M-R II reported as MMR vaccine. These patients currently had negative titers. The nurse reported that these various unspecified patients had received another dose of M-M-R II with no adverse effects. No product quality complaint (PQC) was reported for M-M-R II. Additional information is not expected.
Age: 16.0
Sex: F
Vaccine: VARCEL
Symptoms: Antibody test negative, Local reaction
Clinical narrative: This spontaneous report as received from a nurse refers to a 16 year old female patient. The patient had no pertinent medical history or drug reactions/allergies. In 1998 the patient was vaccinated with the first dose of (Oka/Merck) VARIVAX, lot# not reported, 0.5 nl, subcutaneously (indication reported as vaccination). In 2008 the patient was vaccinated with the second dose of (Oka/Merck) VARIVAX, lot# not reported, 0.5 ml, subcutaneously. No concomitant medications were reported. The nurse reported that patient developed a "significant localized reaction" after administration of (Oka/Merck) VARIVAX on an unspecified date. The nurse did not know if the reaction was after administration of the first or second dose of (Oka/Merck) VARIVAX. The reaction resolved without requiring treatment. The nurse added that the patient was administered the two doses of (Oka/Merck) VARIVAX and subsequently had negative antibody titers to varicella on 09-JUL-2014. No treatment was given for the adverse events. The patient had sought medical attention by office visit. At the time of the reporting, outcome of "negative antibody titers to varicella" was not recovered. The outcome of localized reaction was unknown. Additional information is not expected.
Sex: U
Vaccine: MMR
Symptoms: Expired drug administered, No adverse event
Clinical narrative: This spontaneous report as received from a nurse refers to a 28 unspecified patients of unknown age and unknown gender. The 28 unspecified patients pertinent medical history was not reported. The 28 unspecified patients were received doses from an expired lot of M-M-R II (Dose/Frequency: 0.5ml) (lot # H011885, expiry date: 25-JUN-2014) subcutaneously between 01-JUL-2014 to 09-AUG-2014. No adverse effect was reported. No product quality complaint (PQC) was reported for M-M-R II. Additional information has been requested.
Age: 5.0
Sex: U
Vaccine: MMR
Symptoms: Incorrect storage of drug, No adverse event
Clinical narrative: This spontaneous report was received from a healthcare worker (also reported as office manager) refers to multiple unspecified patients of unknown demographics. No relevant medical history of the patients was reported. On unspecified dates the multiple unspecified patients were vaccinated with VARIVAX (merck) (strength, dose, route, site of administration and lot number were not reported). There were no concomitant medications reported. It was reported that the multiple unspecified patients were administered with VARIVAX (merck) that was stored improperly on unknown dates. There were no adverse effects reported. It was unspecified whether the patients had sought any medical attention. There was no product quality complaint involved. Follow up information has been received from office manager, who stated she may call back or fax information as it become available. Also, reported that M-M-R II was not mentioned in the original call, but did experience a temperature excursion. No further information was available at that time. Follow-up information as received from office manager refers to a 5 years old patient. On 14-JUL-2014 the patient was vaccinated with a dose of improperly stored M-M-R II (lot # reported as J003785, expiration date 25-MAR-2015) (strength, dose, route and site of administration were not reported). This is one of the several reports from the same source. Additional information has been requested.
Age: 1.27
Sex: U
Vaccine: VARCEL
Symptoms: Incorrect storage of drug, No adverse event
Clinical narrative: This spontaneous report was received from a healthcare worker (also reported as office manager) refers to multiple unspecified patients of unkonwn demographics. No relevant medical hisotry of the patients was reported. On unspecified dates the multiple unspecified patients were vaccinated with VARIVAX (Merck) (strength, dose, route, site of administration and lot number were not reported). There were no concomitant medications reported. It was reported that the multiple unspecified patients were administered with VARIVAX (Merck) that was stored improperly on unknown dates. There were no adverse effects reported. It was unspecified whether the patient had sought any medical attetion. There was no product quality complaint involved. Follow up information has been received from office manager, who stated she may call back or fax information as it become available. Also, reported that M-M-R II was not mentioned inthe original call, but did experience a temperature excursion. No further information was available at that time. Follow-up information as received from office manager refers to a 15 months old patient. On 02-JUN-2014 the patient was vaccinated with a dose of improperly stored VARIVAX (Merck) (lot # reported as J012818, expiration date 10-OCT-2015) (strength, dose, route and site of administration were not reported). Thisis one of the several reports from the same source. Additional information has been requested.
Sex: U
Vaccine: VARZOS
Symptoms: Incorrect storage of drug, No adverse event
Clinical narrative: This spontaneous report as received from a registered nurse refers to a patients of unknown age. ZOSTAVAX which were improperly stored were administered to patients over the "past year" (lot#, strength, dosage and route unknown). No adverse effects reported. The outcome of the events was unknown. This is one of several reports received from the same reporter. Additional information has been requested.
Sex: U
Vaccine: HEP
Symptoms: Incorrect storage of drug, No adverse event
Clinical narrative: This spontaneous report as received from a nurse refers to patients of unknown age. The nurse assumed that since 03-JUL-2014, the patients received RECOMBIVAX HB for vaccination (lot no, route not reported). There was no concomitant medication. The nurse reported about temperature excursions. First excursion was on 03-JUL-2014. The worst case temperature was 0 Celsius and the total timeframe was 54 hours. RECOMBIVAX HB was one of the affected products. Other products involved were GARDASIL, ROTATEQ, PNEUMOVAX 23 (single dose) and MMR II. Excursion was supported. No patients concerns or effects were reported to the office post administration of these vaccines. The patients did not seek medical attention. Product quality complaint was not reported. Outcome of events was unknown. This is one of several reports by the same reporter. Additional information has been requested.
Age: 29.0
Sex: F
Vaccine: HPV4
Symptoms: Alopecia, Blood test
Clinical narrative: This spontaneous report as received from a 29 year old female patient who was not pregnant refers to herself. Medical history was not specified. The patient had no drug reactions or allergies. In December 2012, March 2013 and June 2013 (exact dates not specified), the patient received  doses of GARDASIL in the arm (exact route, dose and lot number were not reported). Concomitant therapies included ethinyl estradiol, norgestimate (a generic for of ORTHO TRI-CYCLEN). In February 2013, the patient's hair started falling out. The patient sought medical attention. The patient had blood work done on an unspecified date (results were not reported). Her doctors  had no biological reason why her hair was falling out. The outcome of hair started falling out was not recovered, also reported as her hair was continuing to fall out. The relatedness between hair started falling out and GARDASIL was not reported. Additional information has been requested.
Sex: F
Vaccine: VARCEL
Symptoms: Injection site erythema, Injection site swelling, Nausea, Somnolence, Vomiting
Clinical narrative: This spontaneous report as received from a nurse practitioner refers to a female patient of unknown age. The patient's medical history included chicken pox. On 06-AUG-2014, the patient was vaccinated with (Oka/Merck) VARIVAX, lot number was reported as K000550 with expiry date of 24-JAN-2015. Concomitant therapies included ZYRTEC. On 06-AUG-2014, the patient developed red and raised area at the injection site that is approximately 25mm by 50mm in size. She felt nauseous, drowsy and had been vomiting. The patient sought medical attention. No treatment has been given for the event and no lab was performed. Nurse practitioner reported the patient mentioned she thinks she had chicken pox in the past and received (Oka/Merck) VARIVAX because she has negative titers. Nurse practitioner provided the lot number and expiry date for the sterile diluent that was used to reconstitute (Oka/Merck) VARIVAX as J005350/ expiry date January 2016. The outcome of drowsy, vomiting, nauseous and red and raised area and injection site was reported as not recovered/not resolved. Additional information has been requested.
Sex: U
Vaccine: HPV4
Symptoms: Incorrect storage of drug, No adverse event
Clinical narrative: This spontaneous report as received from a nurse refers to patients of unknown age. The nurse assumed that since 03-JUL-2014, the patients received GARDASIL (lot no, route not reported). There was no concomitant medication. The nurse reported about temperature excursions, with first excursion was on 03-JUL-2014. The worst case temperature was 0 Celsius and the total time frame was 54 hours. GARDASIL was one of the affected products. Other products involved RECOMBIVAX HB, ROTATEQ, PNEUMOVAX23 (single dose) and M-M-R II. Excursion was supported. No patient concerns or effects were reported to office post administration of these vaccines. The patients did not seek medical attention. Product quality complaint was not reported. The outcome of events was unknown. This is one of several reports from the same reporter. Additional information has been requested.
Sex: U
Vaccine: MMR
Symptoms: Incorrect storage of drug, No adverse event
Clinical narrative: This spontaneous report as received from a nurse refers to patients of unknown age. The nurse assumed that since 03-JUL-2014, the patients received MMR II for vaccination (lot no, therapy type, route not reported). There was no concomitant medication. The nurse reported about temperature excursions. First excursion was on 03-JUL-2014. The worst case temperature was 0 Celsius and the total timeframe was 54 hours. MMR II was one of the affected products. Other products involved were RECOMBIVAX HB, ROTATEQ, PNEUMOVAX 23 (single dose) and GARDASIL. Excursion was supported. No patient concerns or effects were reported to office post administration of these vaccines. The patient did not seek medical attention. Product quality complaint was not reported. This is one of the several reports from the same reporter. Additional information has been requested.
Sex: U
Vaccine: RV5
Symptoms: Incorrect storage of drug, No adverse event
Clinical narrative: This spontaneous report as received from a nurse refers to a patients of unknown age. The nurse assumed that since 03-JUL-2014, the patients received ROTATEQ (lot no, route not reported). There was no concomitant medication. The nurse reported about temperature excursions, with first excursion was on 03-JUL-2014. The worst case temperature was 0 Celsius and the total timeframe was 54 hours. ROTATEQ was one of the affected products. Other products involved were RECOMBIVAX HB, PNEUMOVAX 23 (single dose) and GARDASIL and M-M-R II. Excursion was supported. No patient concerns or effects were reported to office post administration of these vaccines. The patients did not seek medical attention. Product quality complaint was not reported. This is one of the several reports from the same reporter. Additional information has been requested.
Age: 0.1
Sex: U
Vaccine: HEPA
Symptoms: No adverse event, Wrong drug administered
Clinical narrative: This spontaneous report as received from a nurse refers to a 1 month old patient. On 08-AUG-2014 the patient was vaccinated with VAQTA, .5 ml, intramuscular. Nurse reported that patient was administered VAQTA 0.5ml instead of RECOMBIVAX HB. The outcome of the event was unknown. No adverse event was reported. Additional information has been requested.
Sex: U
Vaccine: PPV
Symptoms: Incorrect storage of drug, No adverse event
Clinical narrative: This spontaneous report as received from a nurse refers to patients of unknown age. The nurse assumed that since 03-JUL-2014, the patients received PNEUMOVAX 23 for vaccination (lot no, route not reported). There was no concomitant medication. The nurse reported about temperature excursions, with first excursion was on 03-JUL-2014. The worst case temperature was 0 Celsius and the total timeframe was 54 hours. ROTATEQ was one of the affected products. Other products involved were RECOMBIVAX HB, ROTATEQ, and GARDASIL and MMR-II. Excursion was supported. No patient concerns or effects were reported to office post administration of these vaccines, The patients did not seek medical attention. Product quality complaint was not reported. This is one of several reports from the same reporter. Additional information has been requested.
Sex: U
Vaccine: PPV
Symptoms: Inappropriate schedule of drug administration, No adverse event
Clinical narrative: This spontaneous report as received from a pharmacist refers to a patient of unknown age. On 12-AUG-2014 the patient was vaccinated with PNEUMOVAX23 dose 2. The pharmacist reported that patient was inadvertently administered a second dose of PNEUMOVAX23 on 12-AUG-2014, only 2 months after an initial dose of PNEUMOVAX23 was administered (unspecified date). No adverse effect reported. Additional information has been requested.
Age: 3.0
Sex: M
Vaccine: DTAP, HEPA, HIBV, MMR, PNC13, VARCEL
Symptoms: Fatigue, Hypersensitivity, Injection site erythema, Injection site swelling, Injection site warmth
Clinical narrative: Both legs very red, swollen, hot to touch in area where vaccines were administered. Child woke up Tuesday morning with legs swollen, fever, tired and groggy. Doctor prescribed cortisone cream and oral BENADRYL.
Age: 3.0
Sex: M
Vaccine: DTAP, HEPA, HIBV, MMR, PNC13, VARCEL
Symptoms: Pyrexia, Somnolence
Clinical narrative: Both legs very red, swollen, hot to touch in area where vaccines were administered. Child woke up Tuesday morning with legs swollen, fever, tired and groggy. Doctor prescribed cortisone cream and oral BENADRYL.
Age: 18.0
Sex: M
Vaccine: HPV4, HPV4
Symptoms: Convulsion, Electrocardiogram
Clinical narrative: 2 minutes after injection patient had seizure.
Age: 18.0
Sex: M
Vaccine: HPV4, HPV4
Symptoms: Convulsion, Eye movement disorder, Posturing, Tremor
Clinical narrative: 2 minutes after injection patient had seizure.
Age: 18.0
Sex: M
Vaccine: HPV4, HPV4
Symptoms: Convulsion, Electrocardiogram
Clinical narrative: Pt had 2 - 30 sec episodes of seizure after receiving vaccine with posturing - happened 8/14/2014 1200 pm. I gave GARDASIL injection and as I placed Band-Aid over site patient began shaking - eyes rolled back - all extremities shaking.
Age: 18.0
Sex: M
Vaccine: HPV4, HPV4
Symptoms: Convulsion, Eye movement disorder, Posturing, Tremor
Clinical narrative: Pt had 2 - 30 sec episodes of seizure after receiving vaccine with posturing - happened 8/14/2014 1200 pm. I gave GARDASIL injection and as I placed Band-Aid over site patient began shaking - eyes rolled back - all extremities shaking.
Age: 22.0
Sex: M
Vaccine: MMR
Symptoms: Henoch-Schonlein purpura
Clinical narrative: Diagnose with Henoch-Schonlein purpura by primary provider.
Age: 52.0
Sex: F
Vaccine: TDAP
Symptoms: Arthralgia, Asthenia, Back pain, Chills, Cough
Clinical narrative: Chills, weakness, feeling faint, progressed to more chills, fever, sweats, headache, back pain, hip joint pain throughout the night. Fever & chills broke the neck morning but headache continued next day; overall fatigue/weakness for 5 days; onset of minor cough on 5th day for a week.
Age: 52.0
Sex: F
Vaccine: TDAP
Symptoms: Dizziness, Fatigue, Headache, Hyperhidrosis, Pyrexia
Clinical narrative: Chills, weakness, feeling faint, progressed to more chills, fever, sweats, headache, back pain, hip joint pain throughout the night. Fever & chills broke the neck morning but headache continued next day; overall fatigue/weakness for 5 days; onset of minor cough on 5th day for a week.
Age: 28.0
Sex: F
Vaccine: VARCEL
Symptoms: Injection site erythema, Vaccination site inflammation
Clinical narrative: Redness around the vaccinated site aprox 2 cm erythematous patch visible. Skin intact localized inflamation. No tenderness, no fever, no systemic symptoms, no right arm pain, no SOB, no throat tightness, no palpitations. Member advised to go to ER if symptoms worsen.
Age: 39.0
Sex: M
Vaccine: HEP
Symptoms: Chest discomfort, Rash, Throat tightness
Clinical narrative: Rash: starting lower posterior torso, progress to full posterior and anterior trunk > progressing to tightness in throat and chest (1830hrs ER intervention of Benadryl and steroid at this time reversed symptoms).
Sex: U
Vaccine: VARCEL
Symptoms: Incorrect storage of drug, No adverse event
Clinical narrative: This spontaneous report as received from a registered nurse refers to about 7-8 patients of unknown age and gender. On an unknown date, the patients were vaccinated with a 0.5 ml doses of VARIVAX (Merck) (Lot # J008659, expiration date 10-JUL-2015) SQ that underwent a temperature excursion. No adverse effect was reported. Additional information has been requested.
Sex: U
Vaccine: HPV4
Symptoms: Incorrect storage of drug, No adverse event
Clinical narrative: This spontaneous report as received from a healthcare professional refers to a patient of unknown age and gender who on 11-AUG-2014 was vaccinated with GARDASIL, 0.5 ml, intramuscular. The healthcare worker reported that GARDASIL that underwent a temperature excursion has been administered. No adverse effect reported. No further information was provided. The outcome of GARDASIL that underwent a temperature excursion has been administered was unknown. The reporter considered incorrect product storage to be not related to GARDASIL. This is one of several reports received from same source. Additional information has been requested.
Age: 1.28
Sex: M
Vaccine: DPP, HIBV, IPV
Symptoms: Pyrexia
Clinical narrative: Fever of 103 which has not gone away to date.
Age: 63.0
Sex: M
Vaccine: FLU3, PPV
Symptoms: Rash
Clinical narrative: RASH ON ABDOMEN.
Age: 0.15
Sex: M
Vaccine: DTAPIPVHIB, IPV, MNQ, RVX
Symptoms: Disorientation, Pyrexia, Screaming
Clinical narrative: Feverish screaming disoriented runny nose.
Age: 61.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site erythema, Injection site rash
Clinical narrative: Rash and redness around the administered site.
Age: 0.5
Sex: U
Vaccine: RV5
Symptoms: Expired drug administered, No adverse event
Clinical narrative: This spontaneous report as received from a registered nurse refers to a 6 month old patient of unknown gender. Medical history and drug reactions/allergies were not reported. On 19-JUL-2014, the patient was vaccinated with an expired ROTATEQ lot # J002356 expiry date 17-JUL-2014, second dose, oral (dose not reported). Concomitant medication was not reported. No adverse effects reported. This is one of two reports from the same source (1408USA009040). Additional information has been requested.
Age: 60.0
Sex: F
Vaccine: VARZOS
Symptoms: Herpes zoster, Rash, Rash papular
Clinical narrative: Papular like rash started 8/9 in the morning under breasts and spread through the day towards her back. Sunday 8/10 papules appeared near her armpit. ER doctor stated it was shingles.
Age: 61.0
Sex: F
Vaccine: VARZOS
Symptoms: Pruritus, Skin warm, Swelling, Urticaria
Clinical narrative: 3 cm x 6 cm hive/swelling, warm to the touch, itchy. Instructions: take BENADRYL.
Age: 48.0
Sex: F
Vaccine: VARZOS
Symptoms: Blister, Erythema, Local swelling, Pain in extremity, White blood cell count normal
Clinical narrative: Swelling of arm, blisters, redness, hurt or pain.
Age: 23.0
Sex: F
Vaccine: TDAP
Symptoms: Diarrhoea, Headache, Injection site pain, Nausea, Neck pain
Clinical narrative: Pain in (R) deltoid that radiates to shoulder, neck and head. Diarrhea, nausea.
Age: 14.0
Sex: M
Vaccine: HPV4, VARCEL
Symptoms: Face and mouth X-ray abnormal, Facial bones fracture, Jaw fracture, Syncope
Clinical narrative: Patient fainted after receiving Varicella and HPV vaccine.
Age: 13.0
Sex: F
Vaccine: HPV4
Symptoms: Dizziness
Clinical narrative: Patient felt faint after the GARDASIL BP 100/70 _> 88/68 after hydrat and supine rest BP 94/58 stable.
Age: 26.0
Sex: F
Vaccine: TDAP
Symptoms: Cellulitis, Injection site erythema, Injection site pain
Clinical narrative: Pt received BOOSTRIX vaccine on 8/8/14 on 8/11/14 she reported redness and tenderness around site of injection. Pt ended up going to urgent care. She was told she had cellulitis and was given steroid injection and KEFLEX.