chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 70.0
Sex: F
Vaccine: MMR
Symptoms: Antinuclear antibody, Blood uric acid, C-reactive protein, Erythema, Hypoaesthesia
Clinical narrative: Pain, numbness, swelling, redness.
Age: 70.0
Sex: F
Vaccine: MMR
Symptoms: Lipids, Metabolic function test, Pain, Red blood cell sedimentation rate increased, Rheumatoid factor
Clinical narrative: Pain, numbness, swelling, redness.
Age: 70.0
Sex: F
Vaccine: MMR
Symptoms: Swelling, X-ray
Clinical narrative: Pain, numbness, swelling, redness.
Age: 1.02
Sex: F
Vaccine: PNC13, VARCEL
Symptoms: Erythema, Injection site swelling
Clinical narrative: Bump appeared left thigh morning after vaccines. Two days later bump had resolved, no redness but still had some swelling. As of 8/23/15 redness had come back. No other symptoms, does not bother patient.
Age: 18.0
Sex: F
Vaccine: MNQ
Symptoms: Fatigue, Full blood count normal, Injection site erythema, Injection site pain, Malaise
Clinical narrative: 3 days post vaccination sore throat, fevers to 103.0 F, general fatigue and malaise. 7 cm x 7 cm erythematous site of injection and tender. CBC normal, negative Monospot.
Age: 18.0
Sex: F
Vaccine: MNQ
Symptoms: Mononucleosis heterophile test negative, Oropharyngeal pain, Pyrexia
Clinical narrative: 3 days post vaccination sore throat, fevers to 103.0 F, general fatigue and malaise. 7 cm x 7 cm erythematous site of injection and tender. CBC normal, negative Monospot.
Age: 1.33
Sex: M
Vaccine: HEPA, MMR, VARCEL
Symptoms: Blister, Erythema, Skin lesion
Clinical narrative: Too many to count eryth lesions with central small fluid filled vesicles, mostly pencil eraser size some with eryth up to 1 cm, non tender, none crusted.
Age: 5.0
Sex: M
Vaccine: DTAPIPV, MMRV
Symptoms: Abdominal pain, Epistaxis, Flushing, Injection site injury, Injection site urticaria
Clinical narrative: Flushed face, urticaria, abdominal pain epitaxis about 10 min after vaccination. Hives and scratch on left arm at sire of MMR. Given BENADRYL in office and observed. Recovered (hives resolved) and sent home with instructions to use CLARITIN.
Sex: U
Vaccine: VARCEL
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report was received from a licensed vocational nurse and refers to an unspecified number of patients of unknown age and gender. Pertinent medical history or drug allergies/drug reactions were not reported. On an unknown date in 2015 (reported as "since 13-JUL-2015"), the patients were vaccinated with an unspecified number of improperly stored doses of VARIVAX (lot # K002916, expiration date 26-FEB-2016) (dose, strength and route of administration were not reported). There was no concomitant medication reported. Additionally, no adverse effects were reported. This is one of two reports received from the same reporter. Additional information has been requested.
Age: 41.0
Sex: U
Vaccine: PPV
Symptoms: Drug administered to patient of inappropriate age
Clinical narrative: This spontaneous report as received from a Reimbursement OA Specialist, refers to a 41 year old patient of unknown gender. Information about the patient's medical history and concurrent conditions was not provided. On an unknown date, the patient was vaccinated with a dose of PNEUMOVAX 23 (administration route, lot number and expiration date were not provided). No concomitant therapies were reported. According to the reporter the patient was vaccinated outside of the indicated age range. The outcome of the event was unknown at the time of this report. This is one of several reports from the same reporter. Additional information has been requested.
Sex: U
Vaccine: RV5
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report was received from a registered nurse (R.N.) refers to multiple unspecified number of patients of unspecified age and gender. Medical history and concurrent conditions were not reported. On an unknown date, the patients were vaccinated with improperly stored oral, ROTATEQ (Lot # L004453 and exp. 27-MAY-2016; lot # K020183 and exp. 25-JUN-2016) (dose, site and route of administration was not reported). No adverse events were experienced. The outcome of the reported events was unknown. No product quality complaint (PQC) was filed. No further information was provided. This is one of several reports from the same reporter. Additional information has been requested.
Age: 1.0
Sex: F
Vaccine: DTAPHEPBIP, MNQHIB
Symptoms: White blood cell count decreased
Clinical narrative: This case was reported by a nurse via sales rep and described the occurrence of white blood cell count low in a 1-year-old female patient who received MENHIBRIX. Concomitant product included PEDIARIX. On an unknown date, the patient received MENHIBRIX. On an unknown date, an unknown time after receiving MENHIBRIX, the patient experienced white blood cell count low. On an unknown date, the outcome of the white blood cell count low was unknown. It was unknown if the reporter considered the white blood cell count low to be related to MENHIBRIX. Additional details were provided as follows: This case was reported by field representative on behalf of a nurse. The patient also received PEDIARIX at the time of vaccination with MENHIBRIX.
Age: 20.0
Sex: U
Vaccine: HPV4
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report as received from a healthcare worker refers to a 20 year old patient of unknown gender. The patient's concurrent conditions and medical history were not reported. On 13-AUG-2015 the patient was vaccinated with a dose of improperly stored GARDASIL (lot # L010596, exp. date: 16-APR-2017) 0.5 ml, unspecified arm, intramuscularly. No adverse effects were reported. This is one of several reports from the same source. Additional information has been requested.
Age: 43.0
Sex: F
Vaccine: HEP, PPV
Symptoms: Arthralgia, Pain, Pain in extremity
Clinical narrative: This spontaneous report as received from a pharmacist refers to a 43 year old female patient. The patient's pertinent medical history, drug reactions/allergies and concomitant therapies were reported as none. On 12-AUG-2015 the patient was vaccinated with RECOMBIVAX HB (Lot # K020218 exp. date 24-OCT-2016) (dose, frequency and route were not provided) and PNEUMOVAX 23 (Lot # reported as L012215 exp. date 13-JAN-2017) (dose, frequency and route were not provided) on the same arm (unspecified as to which arm). The patient then, sought medical attention and called the pharmacy 30 minutes after receiving both vaccines to report that her hand and wrist (unspecified as to which arm and wrist) hurt while moving her arm. The pharmacist advised the patient to take ibuprofen (dose and frequency unspecified) for pain control. No labs diagnostics studies were performed. No product quality complaint was involved. The outcome of pain in extremity and arthralgia was unknown. The pharmacist did not assess the causal relationship between RECOMBIVX HB, PNEUMOVAX 23 and the events. Additional information has been requested.
Sex: U
Vaccine: HPV4
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report was received from a registered nurse (R.N.) refers to multiple unspecified number of patients of unspecified age and gender. Medical history and concurrent conditions were not reported. On an unknown date, the patients were vaccinated with improperly stored GARDASIL injection (lot # K011562, 08-APR-2017) (dose, site and route of administration was not reported). No adverse events were experienced. The outcome of the reported events was unknown. No product quality complaint (PQC) was filed. This is one of several reports from the same reporter. Additional information has been requested.
Sex: U
Vaccine: VARCEL
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: Information has been received from a healthcare worker referring to an unspecified number of patients of unknown age and gender. The patients' pertinent medical history and concurrent condition were not reported. On unspecified dates since 31-JUL-2015, the patients were vaccinated with improperly stored doses of VARIVAX (lot # L009203, expiration date 17-MAR-2017, dose, frequency and route were unknown). No concomitant medication was reported. No adverse effects were reported. No product quality complaint (PQC) was involved. Additional information has been requested.
Age: 12.0
Sex: M
Vaccine: MNQ, TDAP
Symptoms: Blister
Clinical narrative: Blister to LA.
Age: 1.32
Sex: F
Vaccine: DTAP, HIBV, PNC13
Symptoms: Febrile convulsion, Pyrexia
Clinical narrative: Fever of 103 degrees F with a febrile seizure within 6 hours of receiving Dtap #4, PCV 13 #4, Hib #4.
Sex: U
Vaccine: MMRV
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: Information has been received from a healthcare worker referring to a patient of unknown age and gender. The patient's pertinent medical history and concurrent condition were not reported. On 14-AUG-2015, the patient was vaccinated with an improperly stored dose of PROQUAD (Merck) (lot # K021548, expiration date 06-MAY-2016, dose, frequency and route were unknown). No concomitant medication was reported. No adverse effects were reported. No product quality complaint (PQC) was involved. Additional information has been requested.
Age: 4.0
Sex: F
Vaccine: DTAPIPV, MMRV
Symptoms: Injection site erythema, Injection site warmth
Clinical narrative: Pt. seen in office 08/21/15 for 4 yr WCE; Rec'd 5 yr immunizations (for pre-k). Redness and warmth to (Lt) arm began 08/222/15. Increased s/s on 08/23/15. Non-tender; afebrile on exam for s/s on 08/24/15. Tx with MOTRIN-prn; warm/cold compresses and KEFLEX for (?) cellulitis.
Age: 11.0
Sex: M
Vaccine: HEPA, HPV4, MNQ, TDAP
Symptoms: Peripheral swelling
Clinical narrative: Left arm swelling after administration of Hep A and HPV in that arm. Seen in office. Symptomatic core recommended.
Age: 44.0
Sex: F
Vaccine: HEP, MMR, TDAP
Symptoms: Injection site pain, Nausea, Pyrexia, Rash, Swelling
Clinical narrative: (L)/SQ "allergy" nausea, sore at site, trash swelling with MMR/SQ "throat feels congested" fever 101.0 degrees.
Age: 44.0
Sex: F
Vaccine: HEP, MMR, TDAP
Symptoms: Throat tightness
Clinical narrative: (L)/SQ "allergy" nausea, sore at site, trash swelling with MMR/SQ "throat feels congested" fever 101.0 degrees.
Age: 0.2
Sex: U
Vaccine: DTAPHEPBIP, HIBV, RV5
Symptoms: Crying
Clinical narrative: This spontaneous report was received from a Healthcare worker regarding a 2 month old patient of unknown gender. There was no information about concurrent condition and historical medication. ON an unknown date, the patient was vaccinated with PEDVAXHIB. Other suspect therapies included oral, ROTATEQ vaccinated at the age of 2 months (inappropriate schedule of drug administration) and PEDIARIX. No concomitant medication was reported. On an unknown date the patient developed uncontrollable crying that lasted for a couple of days. Also it was stated that two month old patient received all vaccinations required for a two month old. No product quality complaint (PQC) was involved. The outcome of crying was reported as resolved (as reported fully recovered). The outcome of oral, ROTATEQ vaccinated at the age of 2 months was unknown. The causality between uncontrollable crying and oral, ROTATEQ and PEDVAXHIB was unknown. Additional information is not expected because physician does not want to get contacted.
Sex: M
Vaccine: VARZOS
Symptoms: Accident, Dizziness, Faecal incontinence
Clinical narrative: This spontaneous report was received from a pharmacist via a company representative concerning a male patient of unknown age. No concurrent conditions or medical history were reported. On an unknown date, reported as "July 2nd" (unspecified year), the patient was vaccinated with a dose of ZOSTAVAX (Lot # L002422 Expiration date: 20-APR-2016) subcutaneous (dose, strength and anatomical location of administration were not reported). No concomitant therapy was reported. On an unknown date, reported as "July 2nd" after receiving vaccination, the patient became lightheaded and "lost control of his bowels". The reporter stated that the patient was taken to an unspecified hospital, on an unspecified date, due to unspecified accident (it is not known if the patient was in a car accident or if the "loss of control of bowels" was the accident). It was not known whether the patient was admitted to unspecified hospital. No treatment was given for the adverse event. No Product Quality Complaint (PQC) was involved. The outcome of accident, faecal incontinence and dizziness was unknown. Additional information has been requested.
Sex: U
Vaccine: HPV4
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: Information has been received from a nurse referring to an unknown number of patients of unknown age and gender. No relevant medical history or concurrent conditions were reported. On unknown dates these patients were vaccinated with unspecified doses of GARDASIL (lot # J009788, expiration date 17-MAR-2016; dose and route not reported) which were improperly stored from 05-SEP-2014 through 01-OCT-2014. No adverse effects were reported. This is one of several reports received from the same reporter. Additional information has been requested.
Age: 78.0
Sex: U
Vaccine: PNC13
Symptoms: Musculoskeletal pain, Pain in extremity, Peripheral swelling
Clinical narrative: Shot admin 8/18/15. Patient returned 8/22/15 w/swollen painful arm and shoulder. Doctor presented prednisone.
Age: 43.0
Sex: U
Vaccine: PPV
Symptoms: Drug administered to patient of inappropriate age
Clinical narrative: This spontaneous report as received from a Reimbursement OA Specialist, refers to a 43 year old patient of unknown gender. Information about the patient's medical history and concurrent conditions was not provided. On an unknown date, the patient was vaccinated with a dose of PNEUMOVAX 23 (administration route, lot number and expiration date were not provided). No concomitant therapies were reported. According to the reporter the patient was vaccinated outside of the indicated age range. The outcome of the event was unknown at the time of this report. This is one of several reports from the same reporter. Additional information has been requested.
Age: 52.0
Sex: M
Vaccine: PPV
Symptoms: Cellulitis, Erythema multiforme, Pruritus, Rash
Clinical narrative: Looked like a cellulitis. Rash, erythema multiforme and urticaria pruritus. Cephalexin 500 mg QID, etodolac 400 mg BID.
Sex: U
Vaccine: HEPA
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report was received from a registered nurse and refers to an unspecified number of patients of unknown age and gender. Patients' concurrent conditions and medical history were not provided. On an unknown date, 5 improperly stored doses of VAQTA, injection, lot # K005958 and expiration date 09-FEB-2017 (dose, route of administration and anatomical location were not provided), 3 improperly stored doses of VAQTA, injection, lot # K019560 and expiration date 02-JUN-2017 (dose, route of administration and anatomical location were not provided) and 13 improperly stored doses of VAQTA, injection, lot # I007559 and expiration date 01-JUN-2017 were administered to an unspecified number of patients. There were no concomitant therapies reported. No adverse experiences were reported. No product quality complaint was involved. This is one of several reports from the same source. Additional information has been requested.
Sex: U
Vaccine: VARZOS
Symptoms: Expired product administered, No adverse event
Clinical narrative: This spontaneous report was received from a pharmacist and refers to a patient of unknown age and gender. The patient's concurrent conditions, past medical history and concomitant therapies were not reported. On 08-AUG-2015, the patient received an expired dose of ZOSTAVAX (lot: K000326; expiration: 27-FEB-2015) (dose and frequency were not provided) subcutaneously. No known adverse effects were reported. Additional information has been requested.
Sex: U
Vaccine: VARCEL
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report as received from a Medical Assistant refers to a patient of unknown age and gender. On 10-JUL-2015, the patient was vaccinated with a dose of improperly stored VARIVAX lot # L000454 expiry date 06-JAN-2017 (route and dose were not provided). No adverse effect reported. This is one of several reports received from the same reporter. Additional information has been requested.
Sex: U
Vaccine: VARCEL
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report as received from a Medical Assistant refers to a patient of unknown age and gender. On 09-JUL-2015, the patient was vaccinated with a dose of improperly stored VARIVAX (Merck) lot # L000454 expiry date 06-JAN-2017 (route and dose were not provided). No adverse effect reported. This is one of several reports received from the same reporter. Additional information has been requested.
Sex: U
Vaccine: MMR
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: Information has been received from a nurse referring to an unknown number of patients of unknown age and gender. No relevant medical history or concurrent conditions were reported. On unknown dates these patients were vaccinated with unspecified doses of M-M-R II (lot # H017433, expiration date: 20-SEP-2014; dose and route not reported) which were improperly stored from 05-SEP-2014 through 01-OCT-2014. No adverse effects were reported. This is one of several reports received from the same reporter. Additional information has been requested.
Sex: U
Vaccine: HPV4
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report was received from a registered nurse and refers to an unspecified number of patients of unknown age and gender. The patients' concurrent conditions and medical history were not provided. On an unknown date, 2 improperly stored doses of GARDASIL, injection, lot # K006117 and expiration date 14-JAN-2017 (dose, route of administration and anatomical location were not provided) and 1 improperly stored doses of GARDASIL, injection, lot # K010574 and expiration date 08-APR-2017 (dose, route of administration and anatomical location were not provided) were administered to an unspecified number of patients. There were no concomitant medications reported. No adverse experiences were reported. No product quality complaint was involved. This is one of several reports from the same source. Additional information has been requested.
Age: 45.0
Sex: U
Vaccine: PPV
Symptoms: Drug administered to patient of inappropriate age
Clinical narrative: This spontaneous report as received from a Reimbursement OA Specialist, refers to a 45 year old patient of unknown gender. Information about the patient's medical history and concomitant conditions was not provided. On an unknown date, the patient was vaccinated with a dose of PNEUMOVAX 23 (administration route, lot number and expiration date were not provided). No concomitant therapies were reported. According to the reporter the patient was vaccinated outside of the indicated age range. The outcome of the event was unknown at the time of this report. This is one of several reports from the same reporter. Additional information has been requested.
Sex: U
Vaccine: HEPA
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: Information has been received from a Licensed Practical Nurse referring to a patient of unknown age and gender. Pertinent medical history and drug reactions/allergies were not reported. On 11-AUG-2015 the patient was vaccinated with a dose of improperly stored VAQTA (0.5 ml, lot # J002347, expiration date 04-SEP-2015, dose in series was not reported) intramuscularly. Concomitant drug was not reported. No adverse effects were reported. This is one of the several reports from the same reporter. Additional information has been requested.
Sex: U
Vaccine: HPV9
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: Information has been received from a healthcare worker (also a medical assistant) referring to an unspecified number of patients of unknown age and gender. There was no medical history or drug reaction/allergies reported. On unknown dates the patients was vaccinated with doses of improperly stored GARDASIL 9 (lot # K026247 with expired date 29-JAN-2017, dose and route were unknown). No concomitant medication was provided. No adverse effects were reported. This was one of several reports received from the same reporter. Additional information has been requested.
Sex: U
Vaccine: HIBV
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: Information has been received from a registered nurse referring to unspecified number of patients of unknown age and gender. On unknown dates the patients were vaccinated with doses of PEDVAXHIB (lot # K026533 with expiration date of 07-AUG-2015, lot# L002867 with expiration date of 11-NOV-2017, dose, strength and route unknown), which were exposed to temperatures outside of the recommended range. No adverse effects had been reported. This is one of several reports received from the same reporter. Additional information has been requested.
Sex: U
Vaccine: VARCEL
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report as received from a Medical Assistant refers to a patient of unknown age and gender. On 12-AUG-2015, the patient was vaccinated with an improperly stored dose of VARIVAX lot # L000454 with exp. 06-JAN-2017, (route and dose were not provided). No adverse effect reported. This is one of several reports received from the same reporter. Additional information has been requested.
Sex: U
Vaccine: MMRV
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report was received from a registered nurse and refers to an unspecified number of patients of unknown age and gender. The patient's concurrent conditions and medical history were not provided. On an unknown date, 13 improperly stored doses of PROQUAD (Merck), injection, lot # I005293 and expiration date 17-AUG-2016 (dose, route of administration and anatomical location were not provided) and 5 improperly stored doses of PROQUAD (Merck), injection, lot # I007230 and expiration date 03-SEP-2016 (dose, route of administration and anatomical location were not provided) were administered to an unspecified number of patients. There were no concomitant therapies reported. No adverse experiences were reported. No product quality complaint was involved. This is one of several reports from the same source. Additional information has been requested.
Age: 73.0
Sex: M
Vaccine: PNC13, TDAP
Symptoms: Rash
Clinical narrative: Rash. Fluocinonide small amount BID.
Age: 32.0
Sex: U
Vaccine: PPV
Symptoms: Drug administered to patient of inappropriate age
Clinical narrative: This spontaneous report as received from a Reimbursement OA Specialist, refers to a 32 year old patient of unknown gender. Information about the patient's medical history and concurrent conditions was not provided. On an unknown date, the patient was vaccinated with a dose of PNEUMOVAX 23 (administration route, lot number and expiration date were not provided). No concomitant therapies were reported. According to the reporter the patient was vaccinated outside of the indicated age range. The outcome of the event was unknown at the time of this report. This is one of several reports from the same reporter. Additional information has been requested.
Sex: U
Vaccine: VARCEL
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report as received from a Medical Assistant refers to a patient of unknown age and gender. On 20-JUL-2015, the patient was vaccinate with a improperly stored dose of VARIVAX (Merck) lot # L000454 with exp. 06-JAN-2017, (route and dose were not provided). No adverse effect reported. This is one of several reports received from the same reporter. Additional information has been requested.
Sex: U
Vaccine: MMRV
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report was received from a licensed practical nurse and refers to an unspecified number of patients of unknown age and gender. Pertinent medical history or drug allergies/drug reactions were not reported. On an unknown date in 2015 (reported as "since 13-JUL-2015"), the patients were vaccinated with an unspecified number of improperly stored doses of PROQUAD (Merck) (lot # reported as K002752, expiration date 30-APR-2016) (dose, strength and route of administration were not reported). There was no concomitant medication reported. Additionally, no adverse effects were reported. This is one of two reports received from the same reporter. Additional information has been requested.
Sex: U
Vaccine: MMRV
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report was received from a nurse practitioner referring to an unspecified number of patients of unknown age and gender. The patients' concurrent conditions and medical history were not provided. On an unknown date, the patients were vaccinated with improperly stored doses of PROQUAD (Merck) (Lot No. L007228 exp. 03-SEP-2016) (dose, frequency and route were not described). No concomitant therapies were reported. No adverse event information was provided. No product quality complaint was involved. This is one of two reports received from the same source (MARRS# 1508USA003868). Additional information has been requested.
Sex: U
Vaccine: VARCEL
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report as received from a Medical Assistant refers to a patient of unknown age and gender. On 12-AUG-2015, the patient was vaccinated with an improperly stored dose of VARIVAX (Merck) lot # L000454 with exp. 06-JAN-2017, (route and dose were not provided). No adverse effect reported. This is one of several reports received from the same reporter. Additional information has been requested.
Sex: U
Vaccine: RV5
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: Information has been received from a nurse referring to an unknown number of patients of unknown age and gender. No relevant medical history or concurrent conditions were reported. On unknown dates these patients were vaccinated with unspecified doses of ROTATEQ (lot # K001198, expiration date: 25-OCT-2015, oral; dose not reported) which were improperly stored from 05-SEP-2014 through 01-OCT-2014. No adverse effects were reported. This is one of several reports received from the same reporter. Additional information has been requested.
Sex: U
Vaccine: PPV
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: Information has been received from a Licensed Practical Nurse referring to a patient of unknown age and gender. Pertinent medical history and drug reactions/allergies were not reported. On 05-AUG-2015 the patient was vaccinated with a dose of improperly stored PNEUMOVAX 23 (0.5 ml, lot # L002310, expiration date 08-JUL-2016) intramuscularly. Concomitant drug was not reported. No adverse effects were reported. This is one of the several reports from the same reporter. Additional information has been requested.
Sex: U
Vaccine: VARCEL
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report as received from a Medical Assistant refers to a patient of unknown age and gender. On 09-JUL-2015, the patient was vaccinated with a dose of improperly stored VARIVAX (Merck) lot # L000454, expiry date 06-JAN-2017 (route and dose were not provided). No adverse effect reported. This is one of several reports received from the same reporter. Additional information has been requested.
Sex: U
Vaccine: PPV
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: Information has been received from a Licensed Practical Nurse referring to a patient of unknown age and gender. Pertinent medical history and drug reactions/allergies were not reported. On 12-AUG-2015 the patient was vaccinated with a dose of improperly stored PNEUMOVAX 23 (0.5 ml, lot # L002310, expiration date 08-JUL-2016) intramuscularly. Concomitant drug was not reported. No adverse effects were reported. This is one of the several reports from the same reporter. Additional information has been requested.
Sex: U
Vaccine: VARCEL
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report as received from a Medical Assistant refers to a patient of unknown age and gender. On 09-JUL-2015, the patient was vaccinated with a dose of improperly stored VARIVAX (Merck) lot # L000434, expiry date 06-JAN-2017 (route and dose were not provided). No adverse effect reported. This is one of several reports received from the same reporter. Additional information has been requested.
Sex: U
Vaccine: HEP
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report was received from a registered nurse and refers to an unspecified number of patients of unknown age and gender. The patients' concurrent conditions and medical history were not provided. On an unknown date, 9 improperly stored doses of RECOMBIVAX HB, injection, lot # K020216 and expiration date 17-SEP-2016 (dose, route of administration and anatomical location were not provided) and 17 improperly stored doses of RECOMBIVAX HB, injection, lot # K021444 and expiration date 17-SEP-2016 (dose, route of administration and anatomical location were not provided) were administered to an unspecified number of patients. There were no concomitant therapies reported. No adverse experiences were reported. No product quality complaint was involved. This is one of several reports from the same source. Additional information has been requested.
Sex: U
Vaccine: VARCEL
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report as received from a Medical Assistant refers to a patient of unknown age and gender. On 10-JUL-2015, the patient was vaccinated with a dose of improperly stored VARIVAX (Merck) lot # L000454 expiry date 06-JAN-2017 (route and dose were not provided). No adverse effect reported. This is one of several reports received from the same reporter. Additional information has been requested.
Age: 72.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site vesicles
Clinical narrative: Patient reported appearance of blisters on administration site on 08/23/15 and was prescribed Acyclovir 300mg on 08/25/15.
Sex: U
Vaccine: HPV4
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: Information has been received from a registered nurse referring to unspecified number of patients of unknown age and gender. On unknown dates the patients were vaccinated with GARDASIL (lot # K007264 with expiration date of 02-MAR-2017, dose, strength and route unknown), which were exposed to temperatures outside of the recommended range. No adverse effects had been reported. This is one of several reports received from the same reporter. Additional information has been requested.
Sex: U
Vaccine: PPV
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: Information has been received from a Licensed Practical Nurse referring to a patient of unknown age and gender. Pertinent medical history and drug reactions/allergies were not reported. On 10-AUG-2015 the patient was vaccinated with a dose of improperly stored PNEUMOVAX 23 (0.5 ml, lot # L002310, expiration date 08-JUL-2016) intramuscularly. Concomitant drug was not reported. No adverse effects were reported. This is one of the several reports from the same reporter. Additional information has been requested.
Sex: U
Vaccine: HEP
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: Information has been received from a registered nurse referring to unspecified number of patients of unknown age and gender. On unknown dates the patients were vaccinated with RECOMBIVAX HB (lot # K007263 with expiration date of 09-JUN-2015, lot# J012520 with expiration date of 30-JAN-2016, therapy type, dose, strength and route unknown), which were exposed to temperatures outside of the recommended range. No adverse effects had been reported. This is one of several reports received from the same reporter. Additional information has been requested.
Sex: U
Vaccine: PPV
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: Information has been received from a medical assistant referring to multiple unspecified patients of unknown age and gender. Information about patients' concurrent conditions and medical history was not reported. On unknown dates the patients received RECOMBIVAX HB (dose and route not reported, lot # K020216 with expiration date 17-SEP-2016 that had been improperly stored. No adverse effects were reported. Additional information has ben requested.
Sex: U
Vaccine: PPV
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: Information has been received from a medical assistant referring to unspecified patients of unknown age and gender. On unknown dates the patients were vaccinated with improperly stored PNEUMOVAX 23 (lot # K021881 with expiration date of 30-JUL-2016, lot # L003188 with expiration date of 06-JUL-2016, dose, strength and route unknown). No adverse effects reported. This is one of several reports received from the same reporter. Additional information has been requested.
Sex: U
Vaccine: RV5
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: Information has been received from a registered nurse referring to unspecified number of patients of unknown age and gender. On unknown dates the patients were vaccinated with oral, ROTATEQ (lot # K01147 with expiration date of 07-JUN-2016, lot# K023537 with expiration date of 22-JUN-2016, dose and strength unknown), which were exposed to temperatures outside of the recommended range. No adverse effects had been reported. This is one of several reports received from the same reporter. Additional information has been requested.
Sex: U
Vaccine: PPV
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: Information has been received from a Licensed Practical Nurse referring to a patient of unknown age and gender. Pertinent medical history and drug reactions/allergies were not reported. On 05-AUG-2015 the patient was vaccinated with a dose of improperly stored PNEUMOVAX 23 (0.5 ml, lot # L002310, expiration date 08-JUL-2016) intramuscularly. Concomitant drug was not reported. No adverse effects were reported. This is one of several reports from the same reporter. Additional information has been requested.
Sex: U
Vaccine: HPV4
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: Information has been received from a Licensed Practical Nurse referring to a patient of unknown age and gender. Pertinent medical history and drug reactions/allergies were not reported. On 05-AUG-2015 the patient was vaccinated with a dose of improperly stored GARDASIL (0.5 ml, lot # K008931, expiration date 04-MAR-2017, dose in series was not reported) intramuscularly. Concomitant drug was not reported. No adverse effects were reported. This is one of the several reports from the same reporter. Additional information has been requested.
Sex: U
Vaccine: HPV4
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: Information has been received from a healthcare worker (office manager) referring to unspecified patients of unknown age and gender. In July 2015 (also reported as since 20-JUL-2015), 19 doses of GARDASIL (lot # K010574, expiration date 08-APR-2017), which were exposed to temperatures outside of the recommended range, had been administered to the unspecified patients (strength, route and dose were unknown). No adverse effects had been reported. Additional information has been requested.
Sex: U
Vaccine: HEP
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report was received from a registered nurse (R.N.) refers to multiple unspecified number of patients of unspecified age and gender. Medical history and concurrent conditions were not reported. On an unknown date, the patients were vaccinated with improperly stored RECOMBIVAX HB (Lot # J006027 and expiry date: 16-DEC-2015; lot # J014855 and expiry date: 16-APR-2016; lot # K007263 and expiry date: 09-JUN-2016) (dose, site and route of administration was not reported). No adverse effects were reported. The outcome of the reported events was unknown. No product quality complaint (PQC) was filed. No further information was provided. This is one of several reports from the same reporter. Additional information has been requested.
Sex: U
Vaccine: VARCEL
Symptoms: No adverse event, Product storage error
Clinical narrative: This spontaneous report as received from a Medical Assistant refers to a patient of unknown age and gender. On 10-JUL-2015, the patient was vaccinated with a dose of improperly stored VARIVAX lot # L000454 expiry date 06-JAN-2017 (route and dose were not reported). No adverse effect reported. This is one of several reports received from the same reporter. Additional information has been requested.
Age: 47.0
Sex: M
Vaccine: PPV
Symptoms: Asthenia, Chills, Dyspnoea, Erythema, Leukocytosis
Clinical narrative: Pt was admitted for overnight observation. Generalized weakness, SOB, painful breathing, erythema, swelling, rash, pain, nausea, chills, fever, leukocytosis. Diphenhydramine once, methylprednisolone 125 mg QID.
Age: 47.0
Sex: M
Vaccine: PPV
Symptoms: Nausea, Pain, Painful respiration, Pyrexia, Rash
Clinical narrative: Pt was admitted for overnight observation. Generalized weakness, SOB, painful breathing, erythema, swelling, rash, pain, nausea, chills, fever, leukocytosis. Diphenhydramine once, methylprednisolone 125 mg QID.
Age: 47.0
Sex: M
Vaccine: PPV
Symptoms: Swelling, White blood cell count increased
Clinical narrative: Pt was admitted for overnight observation. Generalized weakness, SOB, painful breathing, erythema, swelling, rash, pain, nausea, chills, fever, leukocytosis. Diphenhydramine once, methylprednisolone 125 mg QID.
Age: 51.0
Sex: F
Vaccine: PPV, PPV
Symptoms: Feeling cold, Hypoaesthesia, Pain in extremity, Paraesthesia
Clinical narrative: This spontaneous report was received from a pharmacist referring to a 51 year old female patient. The patient was allergic to penicillin and sulfa. She had received a dose of an unspecified tetanus vaccine on an unknown date. On 16-AUG-2015 the patient was vaccinated with the first dose of PNEUMOVAX 23 injection (lot # K009876, expiration date 19-MAR-2016), unknown dose, intramuscular in the left arm. No concomitant medication was reported. The same day, the patient began experienced numbness and tingling in the left arm (the arm of the injection site), the reporter stated that it happened on four or five occasions since PNEUMOVAX 23 was administered, and it was only relieved when she "squeezes her left hand for 15 seconds or so", severe pain, also reported as "feels like a punch in the arm and the pain is ten times worse than when I got the tetanus shot", pain in extremity, also reported as "the pain was originally felt in the back and side of the arm, and then radiated past the elbow into the forearm", movement disorder, also reported as "the pain was such that she could not lift a glass of water" and feeling cold, also reported as "her entire body felt cold all night". No treatment was given for the adverse events. On 17-AUG-2015 the patient called to seek medical attention. At the time of the report the outcome of numbness and tingling in the left arm, severe pain, pain in extremity, movement disorder and feeling cold was not recovered/not resolved. Additional information has been requested.
Age: 51.0
Sex: F
Vaccine: PPV, PPV
Symptoms: Feeling cold, Hypoaesthesia, Injected limb mobility decreased, Pain in extremity, Paraesthesia
Clinical narrative: This spontaneous report was received from a pharmacist referring to a 51 year old female patient. The patient was allergic to penicillin and sulfa. She had received a dose of an unspecified tetanus vaccine on an unknown date. On 16-AUG-2015 the patient was vaccinated with the first dose of PNEUMOVAX 23 injection (lot # K009876, expiration date 19-MAR-2016), unknown dose, intramuscular in the left arm. No concomitant medication was reported. The same day, the patient began experienced numbness and tingling in the left arm (the arm of the injection site), the reporter stated that it happened on four or five occasions since PNEUMOVAX 23 was administered, and it was only relieved when she "squeezes her left hand for 15 seconds or so", severe pain, also reported as "feels like a punch in the arm and the pain is ten times worse than when I got the tetanus shot", pain in extremity, also reported as "the pain was originally felt in the back and side of the arm, and then radiated past the elbow into the forearm", movement disorder, also reported as "the pain was such that she could not lift a glass of water" and feeling cold, also reported as "her entire body felt cold all night". No treatment was given for the adverse events. On 17-AUG-2015 the patient called to seek medical attention. At the time of the report the outcome of numbness and tingling in the left arm, severe pain, pain in extremity, movement disorder and feeling cold was not recovered/not resolved. Additional information has been requested.
Age: 37.0
Sex: F
Vaccine: FLUX
Symptoms: Bursitis, Injected limb mobility decreased, Injection site pain, Injection site reaction, Muscular weakness
Clinical narrative: Received influenza vaccine into left shoulder joint. Developed left shoulder pain, weakness, and limited range of motion, which have worsened over the past 10 months. Currently undergoing physical therapy for treatment.
Age: 37.0
Sex: F
Vaccine: FLUX
Symptoms: Nuclear magnetic resonance imaging abnormal, Rotator cuff syndrome
Clinical narrative: Received influenza vaccine into left shoulder joint. Developed left shoulder pain, weakness, and limited range of motion, which have worsened over the past 10 months. Currently undergoing physical therapy for treatment.
Age: 63.0
Sex: M
Vaccine: VARZOS
Symptoms: Herpes zoster, Rash
Clinical narrative: Began breaking out in a rash that was diagnosed (5 days later) as the shingles. 12 day hospital stay and another 3-4 months recovery at home. Treated with something in the hospital. 07/26/2015 - Patient then broke out EXACTLY ONE YEAR LATER with another set of shingles. Two short stays (Fri-Sun and Fri-Sat) stays this year in hospital.
Age: 5.0
Sex: F
Vaccine: DTAPIPV, MMRV
Symptoms: Body temperature increased, Rash generalised
Clinical narrative: Mother states child broke out in rash that started on her face and then proceeded to cover entire body, mother reports child running temperature with rash outbreak. Mother states she has not seen a PCP, but has kept the child at home and has been giving child PRN Acetaminophen for temperature control. Child is reportedly managing well. Advised client's mother to keep child away from anyone who is immunocompromised has not received Varicella vaccine and would be at risk for developing disease until rash is scabbed over, if s/s worsen to always contact PCP.
Age: 2.0
Sex: M
Vaccine: DTAP
Symptoms: Cough, Dyspnoea, Malaise, Nasopharyngitis, Pyrexia
Clinical narrative: Started with cold symptoms, coughing, fever, generall ill feeling. By 04/01/2015 he could not breathe well, was retracting and his O2 was 92% taken to ER.
Age: 12.0
Sex: F
Vaccine: MNQ, TDAP, VARCEL
Symptoms: Ear swelling, Rash generalised, Urticaria
Clinical narrative: Rash all over body, hives, swelling to ears.
Age: 5.0
Sex: M
Vaccine: DTAP, DTAP
Symptoms: Diarrhoea, Dizziness, Fatigue, Vomiting
Clinical narrative: Tired, dizzy, vomiting through out the night and morning, diarrhea throughout the night and morning. Still monitoring him.
Age: 5.0
Sex: M
Vaccine: DTAP, DTAP
Symptoms: Diarrhoea, Pyrexia, Vomiting
Clinical narrative: Tired, dizzy, vomiting through out the night and morning, diarrhea throughout the night and morning. Still monitoring him.
Age: 0.5
Sex: F
Vaccine: DTAP
Symptoms: Acoustic stimulation tests, Childhood disintegrative disorder, Crying, Irritability, Staring
Clinical narrative: Stopped smiling, staring, fussy/crying, could keep awake, will not respond to sound.
Age: 0.5
Sex: F
Vaccine: DTAP
Symptoms: Unresponsive to stimuli
Clinical narrative: Stopped smiling, staring, fussy/crying, could keep awake, will not respond to sound.
Age: 18.0
Sex: M
Vaccine: MNQ, MNQ
Symptoms: Road traffic accident, Syncope
Clinical narrative: Fainting ...causing patient to be involved in a car accident (patient was allowed to immediately leave following administering vaccine and accident happened within 7 minutes of leaving doctors office).
Age: 18.0
Sex: M
Vaccine: HEPA, HPV4, MNQ, VARCEL
Symptoms: Confusional state, Dizziness, Headache, Immediate post-injection reaction, Loss of consciousness
Clinical narrative: Patient dizzy immediately after immunizations given. Passed out and arms stiffened. Was able to get patient is a prone position. The possibility of syncope with HPV vaccine was discussed with patient and his father. Dad and nurse describe patient's arms as stiff but no clonic activity. When Dr. arrived in room approximately 10 seconds later. Then patient was awake and answering questions but initially confused...back to normal quickly. Patient was observed for more than 30 minutes and his physical exam was normal. Patient has a migraine headache that came on 7/21/2015 in afternoon and continued through 7/22/2015. Excedrin did not help headache. No vomiting. Mother called on-call physician 7/22/15 around 10pm. On-call physician recommended aleve and hydration. If worsens should go to ED for further evaluation and we need to recheck in office 7/23/15 morning. Mom reports 7/23/15 in a morning phone call with Dr. that Aleve has helped patient's headache.
Age: 18.0
Sex: M
Vaccine: HEPA, HPV4, MNQ, VARCEL
Symptoms: Musculoskeletal stiffness
Clinical narrative: Patient dizzy immediately after immunizations given. Passed out and arms stiffened. Was able to get patient is a prone position. The possibility of syncope with HPV vaccine was discussed with patient and his father. Dad and nurse describe patient's arms as stiff but no clonic activity. When Dr. arrived in room approximately 10 seconds later. Then patient was awake and answering questions but initially confused...back to normal quickly. Patient was observed for more than 30 minutes and his physical exam was normal. Patient has a migraine headache that came on 7/21/2015 in afternoon and continued through 7/22/2015. Excedrin did not help headache. No vomiting. Mother called on-call physician 7/22/15 around 10pm. On-call physician recommended aleve and hydration. If worsens should go to ED for further evaluation and we need to recheck in office 7/23/15 morning. Mom reports 7/23/15 in a morning phone call with Dr. that Aleve has helped patient's headache.
Age: 1.5
Sex: F
Vaccine: DTAP, HEPA, VARCEL
Symptoms: Injection site pustule, Injection site vesicles, Vaccination site rash
Clinical narrative: A rash developed on the left side of leg where vaccine was administered.  The rash looked very similar to a chicken pox rash and spread on the outside of leg from hip to knee.  The rash consisted of about 50 vesicle "pox looking" bumps and it lasted for over two weeks after the vaccine was given.  The rash did not spread anywhere else on child's body and was only located on the leg of the vaccine.
Age: 52.0
Sex: F
Vaccine: DPP, DTOX
Symptoms: Urticaria
Clinical narrative: Hives 2015.
Age: 30.0
Sex: F
Vaccine: TDAP
Symptoms: Injection site swelling, Malaise, Nausea, Pyrexia
Clinical narrative: Fever, nausea, malaise, site swelling.
Age: 18.0
Sex: M
Vaccine: MNQ
Symptoms: Syncope
Clinical narrative: Syncope episode.
Age: 12.0
Sex: M
Vaccine: TDAP
Symptoms: Injection site erythema, Injection site pruritus, Injection site swelling
Clinical narrative: Golf ball size area of redness and swelling at the injection site with itching at the site only (localized)