chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 60.0
Sex: F
Vaccine: VARZOS
Symptoms: Herpes zoster
Clinical narrative: This spontaneous report as received from a healthcare student refers to a 60 year old female patient. The patient's medical history included multiple sclerosis and respiratory problems. Patient had no drug reactions and allergies. On 23-JUN-2014 the patient was vaccinated with a dose of ZOSTAVAX, 0.65ml, subcutaneous. Concomitant therapies included levothyroxine sodium (manufacturer unknown), metoprolol, PROAIR, montelukast sodium (manufacturer unknown), simvastatin (manufacturer unknown), omeprazole (manufacturer unknown), escitalopram and carbamazepine. The reporter stated that the patient one month after, was diagnosed with shingles. He stated that she had another case of shingles afterwards, but there is no information as to when the second case occurred. The patient sought medical attention by office visit. No treatment was given for the event. There was no product quality complaint. No lab diagnostics studies were performed. The outcome of shingles was reported as recovered/resolved on an unknown date. The causality of the events was not specified by the 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 medical assistant (also reported as healthcare worker) refers to an unspecified number of patients of unknown age and gender. On an unknown date, the patient were vaccinated with MMR II, lot number of Vaccines for Children (VFC) Vaccines J007929, expiration date 28-JUN-2015 (dose and route was not reported) that had a temperature excursion. Patients were also vaccinated with improperly stored TD. No adverse effects were reported. The reporter was unable to provide any patient information or dates of vaccination. This is one of several products received from the same reporter. 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 registered nurse refers to a patient of unknown demographics. The patients medical history and current condition are not reported. On an unknown date the patient was vaccinated with GARDASIL dose 0.5 ml, via intramuscular route. It was reported that the patient is in the office (unspecified) at the time of the report to receive their second dose of GARDASIL. Also reported that the patient received their first GARDASIL a year ago. No adverse events reported. Product Quality Complaint is not reported. The outcome of the event is unknown. Additional information has been requested.
Sex: U
Vaccine: VARCEL
Symptoms: Incorrect storage of drug, No adverse event
Clinical narrative: This spontaneous report as received from a Licensed Practical Nurse refers to an unspecified amount of patients of unknown ages. The nurse reports that VARIVAX (SC, 0.5ml; lot# not reported) that "may" have underwent a temperature excursion has been administered to an unspecified amount of patients. The nurse stated that she did not think the VARIVAX really went out of range because she believed that it was a thermometer issue because other thermometers showed the VARIVAX to be within proper range. No adverse effect reported. Additional information has been requested.
Age: 10.0
Sex: U
Vaccine: MMR
Symptoms: Incorrect storage of drug
Clinical narrative: This spontaneous report as received from a registered nurse refers to a 10 years old patient of unknown gender. On 11-JUL-2014 the patient was vaccinated with MMR II (therapy type: rHA, batch number: J00584, lot: 1681AA, expiry date: 17-APR-2015) that on 03/03/2014 was exposed at an unreported temperature excursion (temperature range: 45F, time frame: 24h). This is one of several reports received from the same reporter. Additional information has been requested.
Age: 2.0
Sex: U
Vaccine: MMR
Symptoms: Incorrect storage of drug, No adverse event
Clinical narrative: This spontaneous report as received from a registered nurse refers to a 2 years old patient of unknown gender. On 11-JUL-2014 the patient was vaccinated with MMR II (therapy type: rHA, batch number: J005846, lot: 1681AA, expiry date: 17-APR-2015) that on 03/03/2014 was exposed at an unsupported temperature excursion (temperature range: 45F, time frame: 24h). No adverse effect was reported. This is one of several reports received from the same reporter. Additional information has been requested.
Age: 12.0
Sex: U
Vaccine: MMR
Symptoms: Incorrect storage of drug, No adverse event
Clinical narrative: This spontaneous report as received from a registered nurse refers to a 12 years old patient of unknown gender. On 11-JUL-2014 the patient was vaccinated with MMR II (therapy type: rHA, batch number: J005846, lot: 1681AA, expiry date: 17-APR-2015) that on 03-03-2014 was exposed to an unsupported temperature excursion (temperature range: 45F, time frame: 24h). No adverse effect was reported. This is one of several reports from the same reporter. Additional information has been requested.
Age: 18.0
Sex: U
Vaccine: MMR
Symptoms: Incorrect storage of drug, No adverse event
Clinical narrative: This spontaneous report as received from a registered nurse refers to a 18 year old patient of unknown gender. On 25-JUN-2014 the patient was vaccinated with MMR II (therapy type: rHA, batch number: J005846, lot: 1681AA, expiry date: 17-APR-2015) that on 03/03/2014 was exposed at an unsupported temperature excursion (temperature range: 45F, time frame: 24h). No adverse effect was reported. This is one of several reports received from the same reporter. Additional information has been requested.
Sex: U
Vaccine: VARCEL
Symptoms: Incorrect storage of drug, No adverse event
Clinical narrative: This spontaneous report as received from a medical assistant (also reported as healthcare worker) refers to an unspecified number of patients of unknown age and gender. On an unknown date, the patients were vaccinated with (Oka/Merck) VARIVAX lot number for Vaccines for Children (VFC) Vaccines J008170, expiration date 02-JUL-2015 (dose and route were not reported) that had a temperature excursion. Patients were also vaccinated with improperly stored TD. No adverse effects were reported. The reporter was unable to provide any patient information or dates of vaccination. This is one of several reports received form 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 medical assistant (also reported as healthcare worker) refers to an unspecified number of patients of unknown age and gender. On an unknown date, the patients were vaccinated with doses of MMR II, lot number for private vaccine stock K007337, expiration date 16-JAN-2016 (also reported as 15-JAN-2016) (dose and route were not reported) that had a temperature excursion. Patients were also vaccinated with improperly stored TD. No adverse effects were reported. The reporter was unable to provide any patient information or dates of vaccination. This is one of several reports received 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 medical assistant (also reported as healthcare worker) refers to an unspecified number of patients of unknown age and gender. On an unknown date, the patients were vaccinated with MMR II, lot number for private vaccine stock J006994, expiration date 14-JUN-2015 (dose and route were not reported) that had a temperature excursion. Patients were vaccinated with improperly stored TD. No adverse effects were reported. The reporter was unable to provide any patient information or dates of vaccination. This is one of several reports received from the same reporter. Additional information has been requested.
Age: 5.0
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 unknown demographis. No relevant medical history of the patients was reported. On unspecified dates the multiple unspecified patients were vaccinated with (Oka/Merck) VARIVAX (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 (Oka/Merck) VARIVAX 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 MMR II was not mentioned in the original call, but did experienced a temperature excursion.
Age: 26.0
Sex: F
Vaccine: HPV4
Symptoms: Hypotonia, Loss of consciousness, Syncope
Clinical narrative: Approx 30 seconds after the administration of the HPV4 Vaccine into the clients right arm, client had an episode of syncopy with LOC but maintained respirations for approx 1 min. Client became limp and PHN, RN caught client and laid client over two chairs while elvating client's legs. Client came to approx 1 min later and returned to baseline after lying down for approx 5 minutes and drinking juice. We had her remain seated for approx 20 minutes.
Age: 12.0
Sex: F
Vaccine: MNQ
Symptoms: Injection site erythema, Injection site oedema, Injection site pain, Injection site pruritus
Clinical narrative: Redness at injection site, itching, pain, edema which increased through out day. Benadryl given by parent and ice applied to area.
Age: 5.0
Sex: F
Vaccine: DPP, MMR
Symptoms: Injection site erythema, Injection site swelling, Injection site warmth
Clinical narrative: Swelling, redness, heat in injection site.  Has had same reaction before, worse this time.
Age: 43.0
Sex: M
Vaccine: FLU3
Symptoms: Amnesia, Blood test, Computerised tomogram, Fatigue, Narcolepsy
Clinical narrative: Tremors, torticollis, pain, narcolepsy, memory loss, fatigue.
Age: 43.0
Sex: M
Vaccine: FLU3
Symptoms: Nuclear magnetic resonance imaging brain, Pain, Torticollis, Tremor
Clinical narrative: Tremors, torticollis, pain, narcolepsy, memory loss, fatigue.
Sex: U
Vaccine: VARCEL
Symptoms: Incorrect storage of drug, No adverse event
Clinical narrative: This spontaneous report as received from a medical assistant (also reported as healthcare worker) refers to an unspecified number of patients of unknown age and gender. On an unknown date, the patients were vaccinated with doses of VARIVAX (Merck) lot number Vaccines for Children (VFC) Vaccines and for private vaccine stock J012645, expiration date 14-OCT-2015 (dose and route were not reported) that had a temperature excursion. Patients were also vaccinated with improperly stored Tetanus-Diphtheria (TD). No adverse effects were reported. The reporter was unable to provide any patient information or dates of vaccination. This is one of several reports received from the same reporter. Additional information has been requested.
Sex: F
Vaccine: PPV
Symptoms: Local swelling
Clinical narrative: This spontaneous report as received from a pharmacist refers to a female patient of unknown age with allergy to sulfa. The patient did not have any medical history. On 11-AUG-2014, the patient was vaccinated with a dose of PNEUMOVAX 23 (Lot # not reported) (0.5 ml dose, intramuscular in the left arm). There were no concomitant therapies. On 11-AUG-2014, in the evening, the patient experienced swelling of the left arm. The swelling was now down to the left forearm. The patient sought medical attention, and the patient was treated himself with TYLENOL and cold compress. The pharmacist stated she did not know if that was the first dose of PNEUMOVAX 23. There were no laboratory diagnostic studies. The outcome of swelling of the left arm was reported as not recovered. Additional information is not expected, since the reporter does not want to be contacted.
Sex: U
Vaccine: HEP
Symptoms: Incorrect storage of drug, No adverse event
Clinical narrative: This spontaneous report as received from a physician refers to an unspecified number of patients (demographics unknown). Pertinent medical history, drug reactions or allergies were not reported. On unknown dates, the patients were vaccinated with RECOMBIVAX HB (dose, route and lot numbers were not provided). The physician stated that approximately 4 or 5 doses of RECOMBIVAX HB were administered to patients after improper storage. No adverse effects were noted. This is one of two reports from the same reporter (MARRS# 1408USA011394). Additional information has been requested.
Age: 12.0
Sex: F
Vaccine: HEPA, HPV4, MNQ
Symptoms: Abdominal pain upper, Vomiting
Clinical narrative: Pt w/ vomiting and stomach cramping for last few weeks.
Age: 16.0
Sex: M
Vaccine: HEP, HEPA, HPV4, IPV, MMRV, MNQ, TDAP
Symptoms: Rash, Rash maculo-papular
Clinical narrative: Maculo papular rash on B/L arms and (L) Lat - abdomen - hydrocortisone applied.
Age: 14.0
Sex: F
Vaccine: HPV4
Symptoms: Abdominal discomfort, Headache, Injected limb mobility decreased, Injection site swelling
Clinical narrative: Arm swelling at injection site, 5cm in diameter. Hard to lift arm. Also c/o stomach upset and headache. Seen in clinic on 8/11/2014. Started on oral antibiotics.
Age: 11.0
Sex: M
Vaccine: MNQ
Symptoms: Induration, Local swelling, Pain, Skin warm
Clinical narrative: Arm swelling, greater than baseball size. Area hard and hot to touch. Area painful. Started on oral antibiotics.
Age: 4.0
Sex: F
Vaccine: VARCEL
Symptoms: Blister, Varicella post vaccine
Clinical narrative: Mild case of varicella break out of small fluid blisters all over body.
Age: 55.0
Sex: F
Vaccine: PPV
Symptoms: Pain in extremity, Rash erythematous
Clinical narrative: Patient reported arm hurt on 08/19/2014 and then on 08/20/2014 there were 4 or 5 red spots on immunized arm.  Advised patient to check with doctor.  Patient went to doctor and Dr. prescribed antibiotic therapy just to be safe.  It was started on 8/20/2014.
Age: 61.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site pruritus, Injection site swelling
Clinical narrative: Swelling and itching at injection site.
Age: 0.33
Sex: M
Vaccine: DTAPHEPBIP, HIBV, PNC13, RV1
Symptoms: Diarrhoea, Frequent bowel movements, Irritability
Clinical narrative: Father called parent to report diarrhea-8 stools in 15 hours fussiness.
Age: 15.0
Sex: F
Vaccine: HEPA, HPV4, MNQ, VARCEL
Symptoms: Cold sweat, Dizziness, Dyskinesia, Eye movement disorder, Loss of consciousness
Clinical narrative: Dizzy, cold, clammy, eyes rolling in back of head, brief loss of consciousness under 10 seconds, jerking movements of arms. Ammonia inhalant was provided and vital signs recorded every 5 min.
Age: 15.0
Sex: F
Vaccine: HEPA, HPV4, MNQ, VARCEL
Symptoms: Nasopharyngitis
Clinical narrative: Dizzy, cold, clammy, eyes rolling in back of head, brief loss of consciousness under 10 seconds, jerking movements of arms. Ammonia inhalant was provided and vital signs recorded every 5 min.
Age: 17.0
Sex: M
Vaccine: HPV4, MNQ
Symptoms: Aggression, Altered state of consciousness, Blood sodium decreased, Catatonia, Computerised tomogram head normal
Clinical narrative: Unresponsiveness, catatonic state.
Age: 17.0
Sex: M
Vaccine: HPV4, MNQ
Symptoms: Decreased interest, Disturbance in attention, Dysphagia, Gastrointestinal tube insertion, Laboratory test normal
Clinical narrative: Unresponsiveness, catatonic state.
Age: 17.0
Sex: M
Vaccine: HPV4, MNQ
Symptoms: Lumbar puncture normal, Major depression, Mental disorder, Nuclear magnetic resonance imaging normal, Psychotic disorder
Clinical narrative: Unresponsiveness, catatonic state.
Age: 17.0
Sex: M
Vaccine: HPV4, MNQ
Symptoms: Social avoidant behaviour, Staring, Tachycardia, Unresponsive to stimuli
Clinical narrative: Unresponsiveness, catatonic state.
Age: 5.0
Sex: F
Vaccine: MMR, VARCEL
Symptoms: Blister, Erythema, Lip blister, Scab, Viral test
Clinical narrative: Blisters on erythematous base on upper lip and chin which popped and scabbed over.
Age: 26.0
Sex: M
Vaccine: TDAP
Symptoms: Pruritus, Urticaria
Clinical narrative: PATIENT STATES 2 DAYS AFTER TDAP WAS GIVEN HE DEVELOPED ITCHINESS AND HIVES THROUGHOUT HIS WHOLE BODY.
Age: 5.0
Sex: F
Vaccine: DTAPIPV, MMRV
Symptoms: Injection site erythema, Injection site pain, Injection site swelling, Injection site warmth
Clinical narrative: C/o pain and hotness at site of location along with swelling and redness.
Age: 19.0
Sex: F
Vaccine: MMR, TDAP
Symptoms: Exposure during pregnancy
Clinical narrative: MMR vaccine administered to pregnant employee.
Age: 0.16
Sex: F
Vaccine: DTAPHEPBIP, HIBV, PNC13, RV5
Symptoms: Autopsy, Condition aggravated, Crying, Death, Diet refusal
Clinical narrative: Non stop crying, fever 102 degrees, refusal to eat.
Age: 0.16
Sex: F
Vaccine: DTAPHEPBIP, HIBV, PNC13, RV5
Symptoms: Heart disease congenital, Pyrexia
Clinical narrative: Non stop crying, fever 102 degrees, refusal to eat.
Age: 67.0
Sex: F
Vaccine: VARZOS
Symptoms: Rash, Rash vesicular
Clinical narrative: Pt experiencing zoster like rash on both arms.
Age: 11.0
Sex: F
Vaccine: HPV4
Symptoms: Dizziness
Clinical narrative: She felt light headed. We watched for 20 mins and gave her some apple juice and she improved.
Age: 5.0
Sex: F
Vaccine: DTAPIPV, VARCEL
Symptoms: Abasia, Abdominal pain, Back pain, CSF lymphocyte count abnormal, CSF monocyte count increased
Clinical narrative: C/o pain 8/14/14 at night, dragging legs and limping 8/15/14. On Sat 8/16/14 pt unable to walk. Currently still in ER.
Age: 5.0
Sex: F
Vaccine: DTAPIPV, VARCEL
Symptoms: CSF neutrophil count increased, CSF protein increased, CSF white blood cell count increased, Constipation, Cough
Clinical narrative: C/o pain 8/14/14 at night, dragging legs and limping 8/15/14. On Sat 8/16/14 pt unable to walk. Currently still in ER.
Age: 5.0
Sex: F
Vaccine: DTAPIPV, VARCEL
Symptoms: Gait disturbance, Laboratory test, Lymphocyte percentage decreased, Meningitis viral, Muscular weakness
Clinical narrative: C/o pain 8/14/14 at night, dragging legs and limping 8/15/14. On Sat 8/16/14 pt unable to walk. Currently still in ER.
Age: 5.0
Sex: F
Vaccine: DTAPIPV, VARCEL
Symptoms: Myelitis transverse, Neutrophil percentage increased, Nuclear magnetic resonance imaging spinal abnormal, Pain, Pain in extremity
Clinical narrative: C/o pain 8/14/14 at night, dragging legs and limping 8/15/14. On Sat 8/16/14 pt unable to walk. Currently still in ER.
Age: 5.0
Sex: F
Vaccine: DTAPIPV, VARCEL
Symptoms: Plasmapheresis, Red blood cells CSF positive, White blood cell count increased
Clinical narrative: C/o pain 8/14/14 at night, dragging legs and limping 8/15/14. On Sat 8/16/14 pt unable to walk. Currently still in ER.
Age: 5.0
Sex: M
Vaccine: DTAPIPV, HEPA, MMR
Symptoms: Injection site erythema, Injection site pain, Injection site swelling, Injection site warmth
Clinical narrative: Marked swelling entire (L) upper arm with erythema, warmth, tenderness. Nonfocal to injection site.
Sex: U
Vaccine: HEPA
Symptoms: Incorrect storage of drug, No adverse event
Clinical narrative: This spontaneous report as received from a physician refers to an unspecified number of patients (demographics unknown). Pertinent medical history, drug reactions or allergies were not reported. On unknown dates, the patients were vaccinated with VAQTA (dose, route and lot numbers were not provided). The physician stated that approximately 4 or 5 doses of VAQTA were administered to patients after improper storage. No adverse effects were noted. This is one of two reports from the same reporter (MARRS# 1408USA011485). Additional information has been requested.
Age: 11.0
Sex: M
Vaccine: HPV4, MNQ, TDAP
Symptoms: Aphasia, Blood glucose normal, Feeling abnormal, Musculoskeletal stiffness, Pallor
Clinical narrative: This spontaneous report as received from a licensed practical nurse refers to an 11 year old male patient. None pertinent medical history, drug reactions or allergies were reported. On 30-JUL-2014 the patient was vaccinated with GARDASIL, 0.5ml, lot number K006449, intramuscular in one arm (reported as "age") (strength, dose number and expiration date were unspecified). Other suspect therapies included TDAP, MENACTRA that were administered in the other arm on the same day. On 30-JUL-2014, 10 or 15 seconds after GARDASIL was administered, the patient zoned out, he turned white, was still and was posturing. The patient stated that he could see and hear the whole time and just could not talk. The outcome of turned white, was still and was posturing was reported as recovered in 15 seconds or so and the patient was completely awake and oriented for the three events on 30-JUL-2014. The result of a finger stick blood sugar obtained on 30-JUL-2014 after the adverse events was 105 (units not reported). The relationship between GARDASIL and the events as not reported. Additional information has been requested.
Age: 11.0
Sex: M
Vaccine: HPV4, MNQ, TDAP
Symptoms: Posturing
Clinical narrative: This spontaneous report as received from a licensed practical nurse refers to an 11 year old male patient. None pertinent medical history, drug reactions or allergies were reported. On 30-JUL-2014 the patient was vaccinated with GARDASIL, 0.5ml, lot number K006449, intramuscular in one arm (reported as "age") (strength, dose number and expiration date were unspecified). Other suspect therapies included TDAP, MENACTRA that were administered in the other arm on the same day. On 30-JUL-2014, 10 or 15 seconds after GARDASIL was administered, the patient zoned out, he turned white, was still and was posturing. The patient stated that he could see and hear the whole time and just could not talk. The outcome of turned white, was still and was posturing was reported as recovered in 15 seconds or so and the patient was completely awake and oriented for the three events on 30-JUL-2014. The result of a finger stick blood sugar obtained on 30-JUL-2014 after the adverse events was 105 (units not reported). The relationship between GARDASIL and the events as not reported. Additional information has been requested.
Age: 4.0
Sex: U
Vaccine: VARCEL
Symptoms: Incorrect storage of drug, No adverse event
Clinical narrative: This spontaneous report as received from a health professional refers to a 4 year old patient. On 17-JUN-2014 the patient was vaccinated with a dose of (oka/merck) VARIVAX (lot # J013907, expiration date: 30-OCT-2015) dose and route not reported) which was stored improperly. There was no adverse effect reported. This is one of several reports from the same source. Additional information is not expected.
Sex: U
Vaccine: PPV
Symptoms: Incorrect storage of drug, No adverse event
Clinical narrative: This spontaneous report as received from a healthcare worker refers to a patient of unknown age and gender. On an unknown date the patient was inadvertently vaccinated with a dose of PNEUMOVAX 23 that had been improperly stored (dosage, route and lot# not reported). No adverse effects reported. The outcome of event was unknown. Additional information has been requested.
Age: 1.0
Sex: U
Vaccine: VARZOS
Symptoms: No adverse event, Wrong drug administered
Clinical narrative: This spontaneous report as received from a healthcare worker refers to a 12 month old patient of unknown age and gender. On 11-AUG-2014 the patient was vaccinated with a dose of ZOSTAVAX instead of a first dose of VARIVAX (dosage, route and lot# not reported). No adverse symptoms reported. The outcome of event was unknown. Additional information has been requested.
Age: 47.0
Sex: F
Vaccine: HEP, MMR, TD
Symptoms: Hypoaesthesia, Paraesthesia
Clinical narrative: Pinky finger and ring fingers are numb and tingly. Went to doctor. She stated it was OK and that it would subside in 2-6 months.
Age: 1.52
Sex: U
Vaccine: VARCEL
Symptoms: Incorrect storage of drug, No adverse event
Clinical narrative: This spontaneous report as received from a health professional refers to a 18 month old patient. On 17-JUN-2014 the patient was vaccinated with a dose of VARIVAX (Merck) (lot # J009728, expiration date: 07-AUG-2015) (dose and route not reported) which was stored improperly. There was no adverse effect reported. This is one of several reports received from the same source. Additional information is not expected.
Sex: U
Vaccine: VARZOS
Symptoms: Expired drug administered, No adverse event
Clinical narrative: This spontaneous report as received from a pharmacy intern refers to a patient of unknown age and gender. On 14-AUG-2014 the patient was inadvertently administered ZOSTAVAX (lot # J004599, expiration date 18-JUL-2014, dose was unknown) subcutaneous which expired on 18-JUL-2014. No adverse effects were reported. The outcome of the events was unknown. Additional information has been requested.
Age: 6.0
Sex: U
Vaccine: DTAPIPV
Symptoms: Urticaria
Clinical narrative: Hives.
Age: 12.0
Sex: F
Vaccine: HPV4, MNQ, TDAP
Symptoms: Asthenia, Chills, Decreased appetite, Dizziness postural, Fatigue
Clinical narrative: Vaccines were administered at 3:00 pm. That night boths were swollen and maculopapular rashes, on the arms that progressed to lower; (+) fever of 101-102 degrees C and chills with vomiting. Lost of appetite with severe tiredness; in bed with no energy x 1 week, dizzy getting up. On 8/18, developed papular rashes early in am starting on the back and itchy; progressed to general, (+) vomiting. Lost weight. Client went to pharmacy - given CLARITIN 10 mg, taken at 6 pm. By 11:30 pm, rashes started disappearing. Client got up and well today 8/20. Able to retain food - grapefruit, cereal, donut. Client came back to clinic today; not in distress, alert, oriented.
Age: 12.0
Sex: F
Vaccine: HPV4, MNQ, TDAP
Symptoms: Local swelling, Pruritus, Pyrexia, Rash, Rash maculo-papular
Clinical narrative: Vaccines were administered at 3:00 pm. That night boths were swollen and maculopapular rashes, on the arms that progressed to lower; (+) fever of 101-102 degrees C and chills with vomiting. Lost of appetite with severe tiredness; in bed with no energy x 1 week, dizzy getting up. On 8/18, developed papular rashes early in am starting on the back and itchy; progressed to general, (+) vomiting. Lost weight. Client went to pharmacy - given CLARITIN 10 mg, taken at 6 pm. By 11:30 pm, rashes started disappearing. Client got up and well today 8/20. Able to retain food - grapefruit, cereal, donut. Client came back to clinic today; not in distress, alert, oriented.
Age: 12.0
Sex: F
Vaccine: HPV4, MNQ, TDAP
Symptoms: Rash papular, Vomiting, Weight decreased
Clinical narrative: Vaccines were administered at 3:00 pm. That night boths were swollen and maculopapular rashes, on the arms that progressed to lower; (+) fever of 101-102 degrees C and chills with vomiting. Lost of appetite with severe tiredness; in bed with no energy x 1 week, dizzy getting up. On 8/18, developed papular rashes early in am starting on the back and itchy; progressed to general, (+) vomiting. Lost weight. Client went to pharmacy - given CLARITIN 10 mg, taken at 6 pm. By 11:30 pm, rashes started disappearing. Client got up and well today 8/20. Able to retain food - grapefruit, cereal, donut. Client came back to clinic today; not in distress, alert, oriented.
Age: 12.0
Sex: F
Vaccine: MNQ, TDAP, VARCEL
Symptoms: Erythema, Induration, Local reaction
Clinical narrative: Patient developed localized reaction approx. 1 hr. after administration on 8/18/2014. On 8/20/2014 patient was seen in clinic for 6cm red, hard induration. Treated with oral BENADRYL.
Age: 67.0
Sex: F
Vaccine: VARCEL
Symptoms: Incorrect storage of drug, No adverse event
Clinical narrative: This spontaneous report as received from a pharmacist refers to a 67 year old female patient. Medical history and concurrent conditions were not reported. On 05-AUG-2014 the patient was vaccinated with VARIVAX. Dose, route, lot number and expiration date were not reported. The pharmacist reported that the patient received VARIVAX instead of (Oka/Merck) ZOSTAVAX (on 05-AUG-2014). No adverse effects were reported. This is one of two reports from the same source (other case # 1408USA003125). Additional information has been requested.
Sex: U
Vaccine: PPV
Symptoms: No adverse event, Overdose
Clinical narrative: This spontaneous report as received from a pharmacist refers to a patient of unknown age. The pharmacist reported that a patient might have received two doses of PNEUMOVAX 23 (lot#, expiration date, dose, route and indication not reported) within 24 hours on an unknown date. She stated that she was unsure if the patient had ever received any previous doses of PNEUMOVAX 23 in the past. No adverse effects reported. Additional information has been requested.
Age: 65.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site erythema, Injection site pain, Pruritus
Clinical narrative: Pt came to pharmacy complaining redness and soreness at injection site. C/o itching. Explained to pt to apply cold compresses and take ibuprofen and possibly BENADRYL.
Age: 2.0
Sex: U
Vaccine: MMR, 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 unknown demographics. No relevant medical history of the patients was reported. On unspecified dates the multiple unspecified patients were vaccinated with (Oka/Merck) VARIVAX (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 (Oka/Merck) VARIVAX 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 a healthcare professional refers to a 2 years old patient. On 02-JUN-2014 the patient was vaccinated with a dose of improperly stored M-M-R II HSA (lot # J003785, expiration date 28-MAR-2015) (strength, dose, route and site of administration were not reported) and a dose of (Oka/Merck) VARIVAX (lot # J009728, expiration date 10-OCT-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: 1.26
Sex: M
Vaccine: DTAP, MMR, PNC13
Symptoms: Rash
Clinical narrative: Rash induced by measles vaccination.
Age: 47.0
Sex: M
Vaccine: FLU3
Symptoms: Muscle spasms
Clinical narrative: Patient complains that he has cramps in his right leg, his back, hip and his chest.
Sex: U
Vaccine: VARZOS
Symptoms: Incorrect storage of drug, No adverse event
Clinical narrative: This spontaneous report as received from a Licensed Practical Nurse refers to an unspecified number of patients of unknown age and gender. On an unknown date in August 2014 ("on unspecified dates after 31-JUL-2014") an unspecified number of patients were vaccinated with doses of ZOSTAVAX that were underwent a temperature excursion (stability was supported), subcutaneously for prophylaxis (dosages, and lot# not specified). No adverse experiences reported. The outcome of event was unknown. This is one of several reports from the same source. Additional information has been requested.
Age: 12.0
Sex: F
Vaccine: MNQ
Symptoms: Injection site swelling
Clinical narrative: Swollen arm where the vaccine was given.
Age: 78.0
Sex: F
Vaccine: VARCEL
Symptoms: No adverse event, Wrong drug administered
Clinical narrative: This spontaneous report as received from a pharmacist refers to a 78 year old female patient. Medical history and concomitant conditions were not reported. On 05-AUG-2014, the patient was vaccinated with VARIVAX (Merck). Dose, route, lot number and expiration date were not reported. The pharmacist reported that the patient received VARIVAX (Merck) instead of ZOSTAVAX (Merck) (on 05-AUG-2014). No adverse effects were noted. This is one of two reports from the same source (other case # 1408USA011578). Additional information has been requested.
Age: 1.28
Sex: M
Vaccine: DTAP, HIBV, PNC13
Symptoms: Injection site reaction, Pyrexia, Rash maculo-papular
Clinical narrative: Seen in our office 8/20 due to 1 day hx of fever and rash approx 4 x 6 cm macular papular rash on immune site (R) thigh. Temp 101. Of not had fever with 2 mo immuz no rash at that time. See today.
Age: 4.0
Sex: F
Vaccine: DTAPIPVHIB, MMR, VARCEL
Symptoms: Diarrhoea, Injection site erythema, Injection site swelling
Clinical narrative: Local swelling and erythema at injection site and diarrhea.
Age: 11.0
Sex: M
Vaccine: TDAP
Symptoms: Injection site swelling
Clinical narrative: Swelling to the injection site. Presented to urgent care.
Age: 51.0
Sex: F
Vaccine: PPV, VARZOS
Symptoms: Injection site erythema, Injection site pain, Injection site pruritus, Injection site swelling
Clinical narrative: (Left arm). She returned 24 hours after vaccination with a large red swollen arm at and around the site of the ZOSTAVAX injection. It was about 5 inches in diameter and very raised. She complained of pain and itching at the site.
Age: 72.0
Sex: F
Vaccine: VARZOS
Symptoms: Induration, Injection site erythema, Injection site pain, Injection site swelling, Injection site warmth
Clinical narrative: Within 24 hours -> swelling, redness, heat and soreness at injection site. Reaction has progressed in size to 2 1/2" x 5 1/2-6" redness, soreness and swelling. Visited PCP 08-20-14 gave SEPTRA rx -> Dr. said induration present, low grade fever today and yesterday.
Age: 72.0
Sex: F
Vaccine: VARZOS
Symptoms: Pyrexia
Clinical narrative: Within 24 hours -> swelling, redness, heat and soreness at injection site. Reaction has progressed in size to 2 1/2" x 5 1/2-6" redness, soreness and swelling. Visited PCP 08-20-14 gave SEPTRA rx -> Dr. said induration present, low grade fever today and yesterday.
Age: 58.0
Sex: M
Vaccine: PPV
Symptoms: Inflammation, Rash, Rash erythematous, Skin warm
Clinical narrative: Elongated red, warm, and inflamed rash on arm; bicep/tricep area, spread to elbow.
Age: 1.26
Sex: M
Vaccine: DTAP
Symptoms: Urticaria
Clinical narrative: Hives - local to area.
Age: 72.0
Sex: M
Vaccine: VARZOS
Symptoms: Rash
Clinical narrative: This spontaneous report was received from a pharmacist refers to a 72 year old male patient. Patient's medical history and drug reactions/allergies were not reported. On 08-AUG-2014, the patient was vaccinated with ZOSTAVAX (lot # J013451, expiration date: 24-JAN-2015), 0.65 ml, subcutaneous. Concomitant therapies included losartan potassium (manufacturer unknown), hydrochlorothiazide (manufacturer unknown), metformin (manufacturer unknown) and potassium (manufacturer unknown). On 08-AUG-2014, patient experienced rash but was unsure if had the rash before ZOSTAVAX administration. On an unknown date, the patient was treated with VALTREX. No lab diagnostics studies were reported. On an unknown date, the patient sought medical attention and went to the doctor's office. The outcome of rash was unknown. Additional information has been requested.
Sex: U
Vaccine: HEP
Symptoms: Incorrect storage of drug, No adverse event
Clinical narrative: This spontaneous report was received from a health care worker (office manager) refers to 3 unspecified patients of unknown demographics. No medical history was reported. The reporter stated that the 3 unspecified patients were administered RECOMBIVAX HB (dose, route and frequency unspecified) that was stored improperly. No concomitant medications were reported. Nurse was then placed on the line to answer additional questions regarding event. No adverse effects were reported. No further information was provided. This is one of the two reports received from the same reporter and linked to case. All Telephone attempts to obtain follow up information have been unsuccessful. Follow up has been received from the office manager. The office manager stated this temperature excursion was supported and the vaccines were out of range for approximately 3 hours. The office manager was unable to provide patient identifiers and dates of administration at this time, but was able to provide lot numbers and expiration dates for RECOMBIVAX HB: lot# reported as J011235, expire date 16-DEC-2015. Additional information has been requested.
Sex: U
Vaccine: PPV
Symptoms: Expired drug administered, No adverse event
Clinical narrative: This spontaneous report was received from a pharmacist refers to a patient of unknown age and gender. Medical history was not reported. The pharmacist informed that on 14-AUG-2014 the patient was inadvertently vaccinated with an expired PNEUMOVAX 23 injection 25, 0.5 ml, lot # J009827, expiration date; 10-AUG-2014 (route was not reported). Concomitant therapy was not reported. No adverse experiences reported. This is one of several reports received from the same source. Additional information has been requested.
Sex: U
Vaccine: VARCEL
Symptoms: Incorrect storage of drug, No adverse event
Clinical narrative: This spontaneous report as received from a pharmacist via a company representative refers to 8 patients of unknown age and gender. On an unknown date these 8 patients were vaccinated with a dose of (Oka/Merck) VARIVAX (dose, route not reported, lot# J008649, expiration date 10-JUL-2015) that was improperly stored in the refrigerator between 2C-8C and was reported no longer viable. Concomitant medications were not provided. No adverse effects were reported. 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 an unspecified number of patients of unknown age and gender. On unknown dates in August 2014 ("on unspecified dates after 31-JUL-2014") an unspecified number of patients were vaccinated with doses of PROQUAD that were underwent a temperature excursion (stability was supported), subcutaneously (dosages, lot# not specified). No adverse experiences reported. The outcome of event was unknown. This is one of several reports received from the same source.  Additional information has been requested.
Sex: U
Vaccine: HEP
Symptoms: Incorrect storage of drug, No adverse event
Clinical narrative: This spontaneous report was received from a health care worker (office manager) refers to 3 unspecified patients of unknown demographics. No medical history was reported. The reporter stated that the 3 unspecified patients were administered ROCOMBIVAX (dose, route and frequency unspecified) that was stored improperly. No concomitant medications were reported. Nurse was then placed on the line to answer additional questions regarding event. No adverse effects were reported. No further information was provided. This is one of two reports received from the same reporter and linked to case. All Telephone attempts to obtain follow up information have been unsuccessful. Follow up has been received from the office manager. The office manager stated this temperature excursion was supported and the vaccines were out of range for approximately 3 hours. The office manager was unable to provided patient identifiers and dates of administration at this time, but was able to provide lot numbers and expiration dates for RECOMBIVAX: lot#0384AE; expire date 02-NOV-2014. Additional information has been requested.
Sex: U
Vaccine: PPV
Symptoms: Expired drug administered, No adverse event
Clinical narrative: This spontaneous report was received from a pharmacist refers to a patient of unknown age and gender. Medical history was not reported. The pharmacist informed that on 14-AUG-2014 the patient was inadvertently vaccinated with an expired PNEUMOVAX 23 injection 25, 0.5 ml, lot # J009827, expiration date: 10-AUG-2014 (route was not reported). Concomitant therapy was not reported. No adverse experiences reported. This is one of several reports received from the same source. Additional information has been requested.
Age: 1.26
Sex: U
Vaccine: VARCEL
Symptoms: Incorrect storage of drug, No adverse event
Clinical narrative: This spontaneous report as received from a health professional refers to a 15 month old patient. On 19-JUN-2014, the patient was vaccinated with a dose of VARIVAX (Merck) (lot # J013907, expiration date: 30-OCT-2015, dose and route not reported) which was stored improperly. There was no adverse effect reported. This is one of several reports received from the same source. Additional information is not expected.
Sex: U
Vaccine: MMR
Symptoms: Incorrect storage of drug
Clinical narrative: This spontaneous report as received from a health care worker (office manager) refers to an unspecified amount of patients of unknown age. On unknown dates the patients were vaccinated with M-M-R II (lot # J010993, expire dates 06-SEP-2015) (dose and route not reported). The office manager stated this temperature excursion was supported and the vaccines were out of range for approximately 3 hours. This is one of several reports received from the same source. Additional information has been requested.
Sex: U
Vaccine: VARCEL
Symptoms: Incorrect storage of drug, No adverse event
Clinical narrative: This spontaneous report as received from a Licensed Practical Nurse refers to an unspecified number of patients of unknown age and gender. On an unknown date in August 2014 ("on unspecified dates after 31-JUL-2014") an unspecified number of patients were vaccinated with doses of VARIVAX (Merck) that were underwent a temperature excursion (stability was supported), subcutaneously (dosages and lot# not specified). No adverse experiences reported. The outcome of event was unknown. This is one of several reports received from the same source. Additional information has been requested.
Sex: U
Vaccine: HEP
Symptoms: Incorrect storage of drug, No adverse event
Clinical narrative: This spontaneous report was received from a health care worker (office manager) refers to 3 unspecified patients of unknown demographics. No medical history was reported. The reporter stated that the 3 unspecified patients were administered RECOMBIVAX (lot# not reported) (dose, route and frequency unspecified) that was stored improperly. No concomitant medications were reported. Nurse was then placed on the line to answer additional questions regarding event. No adverse effects were reported. No further information was provided. This is one of the two reports received from the same reporter and linked to case. All telephone attempts to obtain follow up information have been unsuccessful. Follow up has been received from the office manager. The office manager stated this temperature excursion was supported and the vaccines were out of range for approximately 3 hours. The office manager was unable to provide patient identifiers and dates of administration at this time, but was able to provide lot numbers and expiration dates for RECOMBIVAX: lot# H014132, expire date 08-FEB-2015. Additional information has been requested.
Sex: U
Vaccine: MMR
Symptoms: Incorrect storage of drug
Clinical narrative: This spontaneous report as received from a health care worker (office manager) refers to an unspecified amount of patients of unknown age. On unknown dates the patients were vaccinated with M-M-R II (lot # J004204, expire date 12-APR-2015) (dose and route not reported). The office manager stated this temperature excursion was supported and the vaccines were out of range for approximately 3 hours. This is one of several reports received from the same source. Additional information has been requested.
Sex: U
Vaccine: HEP
Symptoms: Incorrect storage of drug, No adverse event
Clinical narrative: This spontaneous report was received from a health care worker (office manager) refers to 3 unspecified patients of unknown demographics. No medical history was reported. The reporter stated that the 3 unspecified patients were administered RECOMBIVAX (lot# not reported) (dose, route and frequency unspecified) that was stored improperly. No concomitant medications were reported. Nurse was then placed on the line to answer additional questions regarding event. No adverse effects were reported. No further information was provided. This is one of two reports received from the same reporter and linked to case. All telephone attempts to obtain follow up information have been unsuccessful. Follow up has been received from the office manager. The office manager stated this temperature excursion was supported and the vaccines were out of range for approximately 3 hours. The office manager was unable to provide patient identifiers and dates of administratoin at this time, but was able to provide lot numbers and expiration dates for RECOMBIVAX: lot# reported as K006262, expire date 17-DEC-2015. Additional information has been requested.
Sex: U
Vaccine: MMR
Symptoms: Incorrect storage of drug
Clinical narrative: This spontaneous report as received from a health care worker (office manager) refers to an unspecified amount of patients of unknown age. On unknown dates the patients were vaccinated with M-M-R II (lot # reported as J010158, expire date 06-SEP-2015) (dose and route not reported). The office manager stated this temperature excursion was supported and the vaccines were out of range for approximately 3 hours. This is one of several reports received from the same source. Additional information has been requested.
Sex: U
Vaccine: MMR
Symptoms: Incorrect storage of drug
Clinical narrative: This spontaneous report as received from a health care worker (office manager) refers to an unspecified amount of patients of unknown age. On unknown dates the patients were vaccinated with M-M-R II (lot # J011332, expire date 13-SEP-2015) (dose and route not reported). The office manager stated this temperature excursion was supported and the vaccines were out of range for approximately 3 hours. This is one of several reports received from the same source. Additional information has been requested.
Age: 83.0
Sex: M
Vaccine: VARZOS
Symptoms: Herpes zoster
Clinical narrative: This spontaneous report as received from a physician refers to a 83 year old male patient with allergy to penicillin and history of lung cancer. On 25-JAN-2008 the patient was vaccinated with a dose of ZOSTAVAX (lot#, dose, route not reported). Concomitant medications were not provided. On 24-MAR-2014 the patient developed shingles. The patient was given VALTREX for treatment. No lab diagnostics studies were performed. The outcome of shingles was reported as recovered on an unspecified date in 2014. Additional information is not expected because the reporter did not want to be contacted.
Age: 1.43
Sex: U
Vaccine: VARCEL
Symptoms: Incorrect storage of drug, No adverse event
Clinical narrative: This spontaneous report as received from a health professional refers to a 17 month old patient. On 17-JUN-2014 the patient was vaccinated with a dose of VARIVAX (Merck) (lot # J009728, expiration date: 07-AUG-2015, dose and route not reported) which was stored improperly. There was no adverse effect reported. This is one of several reports received from the same source. Additional information is not expected.