chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Sex: U
Vaccine: VARCEL
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report was received from a health professional (immunization official) and refers to an unspecified number of patients of  unknown age and sex. No pertinent medical history or concurrent conditions were reported. On an unknown date, the patients were vaccinated with improperly stored (Oka/Merck) VARIVAX through an unspecified route. No adverse effects were reported. The outcome of incorrect product storage was unknown. 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 vocational nurse refers to multiple unspecified patients of unknown age and gender. The patients' pertinent medical history and concurrent conditions were not provided. On an unknown date, the patients were vaccinated with doses of PROQUAD (route, lot numbers and expiration dates were not provided). On an unknown date, there was incorrect product storage as multiple unspecified patients had received PROQUAD that were improperly stored. No adverse event were reported. It was unknown if the patients sought medical attention. At the time of the report, the patients' status was unknown. Additional information has been requested.
Age: 61.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site erythema, Injection site pruritus, Injection site swelling
Clinical narrative: This spontaneous report as received from a pharmacist refers to a 61 year old female patient with sulfa hypersensitivity who on 09-MAR-2015, was prescribed an unspecified dose of prednisone for an unspecified reason. Historical conditions were not reported. On 12-JUN-2015, the patient was vaccinated with one dose of ZOSTAVAX (lot # L008357, expiration date 11-JUN-2016), 0.65 ml, subcutaneous. It was confirmed that the patient was no longer taking Prednisone at the time of the ZOSTAVAX administration, the stopped date of Prednisone was unspecified by the primary reporter. 13-JUN-2015, the patient experienced injection site erythema reported as "redness", injection site pruritus "reported as itching" and injection site swelling. The patient sought medical attention calling to the pharmacy. The pharmacist stated that treatment was recommended in the form of ice application to the injection site, and an unspecified dose of BENADRYL. The outcome of injection site erythema, injection site pruritus and injection site swelling was reported as not recovered/not resolved. The reporter did not assess the relatedness of ZOSTAVAX to injection site erythema, injection site pruritis and injection site swelling. No cancer or overdose were related to this case. Lot # L008357 is valid lot number for ZOSTAVAX, expiration date 11-JUN-2016. Additional information has been requested.
Sex: U
Vaccine: RV5
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report as received from a medical assistant refers to an unspecified number of patients of unknown age and gender. No current conditions and medical history were provided. The reporter stated that on 24-MAR-2015, 30-MAR-2015, 09-APR-2015, 20-APR-2015, 23-APR-2015, 26-APR-2015, 05-MAY-2015, and 07-MAY-2015, an unspecified number of patients were vaccinated with doses that were exposed to temperatures outside of the recommended range of ROTATEQ, lot # J011340, expiration date 14-MAY-2015, oral. No concomitant medication therapy was provided. No adverse effects has been reported. This is one of two reports received 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 as received from a registered nurse refers to an unspecified patients of unknown age and gender. The patients' medical history and current conditions were not provided. On an unknown dates, the patients were vaccinated with a doses of improperly stored ROTATEQ (lot #, expiration dates and doses were not reported) route defaulted to oral. No adverse effects were reported. There was no product quality complaint (PQC) involved. This is one of several reports received from the same reporter. Additional information has been requested.
Age: 2.0
Sex: U
Vaccine: HIBV
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: Information has been received from a Registered Nurse referring to a 2 year old patient of unknown gender. Information about patient's concurrent conditions and medical history was not reported. On 25-JUN-2015 the patient was vaccinated with a dose of improperly stored LIQUID PEDVAXHIB (route not reported, lot # reported as K026532, dose 0.5 (unit not provided). Concomitant medications were not provided. No adverse effect was reported. This is one of several reports received from the same reporter. Additional information has been requested.
Age: 0.18
Sex: U
Vaccine: HIBV
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: Information has been received from a Registered Nurse referring to a 9 week old patient of unknown gender. Information about patient's concurrent conditions and medical history was not reported. On 22-JUN-2015 the patient was vaccinated with a dose of improperly stored PEDVAXHIB (route not reported, lot # reported as K025004, dose 0.5 (unit not provided)). Concomitant medications were not provided. No adverse effect was reported. This is one of several reports received from the same reporter. Additional information has been requested.
Age: 0.62
Sex: U
Vaccine: HIBV
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: Information has been received from a Registered Nurse referring to a 7 month old patient of unknown gender. Information about patient's concurrent conditions and medical history was not reported. On 22-JUN-2015 the patient was vaccinated with a dose of improperly stored PEDVAXHIB (route not reported, lot # reported as K025004, dose 0.5 (unit not provided)). Concomitant medications were not provided. No adverse effect was reported. This is one of several reports received from the same reporter. Additional information has been requested.
Age: 0.34
Sex: F
Vaccine: HEP
Symptoms: Medication error, No adverse event
Clinical narrative: This spontaneous report as received from a register nurse refers to a 4 month old female patient. Concurrent or medical conditions were not reported. On 07-DEC-2014, the patient was vaccinated with the first dose of RECOMBIVAX HB lot #K008986, expiration date 01-APR-2016, on 10-APR-2015, the patient was vaccinated with the second dose of RECOMBIVAX HB lot # reported as K022265, expiration date 22-OCT-2016 and on 12-JUN-2015, the patient was vaccinated with the third dose of RECOMBIVAX HB lot # reported as L007558, expiration date 10-NOV-2016 (strength, doses and route of any of the doses received were not reported). No adverse effect was reported. Additional information has been requested.
Sex: U
Vaccine: HEPA
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report was received from a healthcare worker refers to an unspecified patients of unknown age. The patient's medical history, concurrent conditions and concomitant medications were not reported. On an unknown date, the patients were vaccinated with improperly stored VAQTA 25/0.5 (lot #, dose and frequency were unknown). No adverse effects reported. The outcome of the events was unknown. No product quality complaint (PQC) was involved. No further information was provided. This is one of several reports received from the same reporter. Additional information has been requested.
Age: 0.11
Sex: U
Vaccine: HIBV
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: Information has been received from a Registered Nurse referring to a 6 week old patient of unknown gender. Information about patient's concurrent conditions and medical history was not reported. On 24-JUN-2015 the patient was vaccinated with a dose of improperly stored LIQUID PEDVAXHIB (route not reported, lot # reported as K026532, dose 0.5 (unit not provided). Concomitant medications were not provided. No adverse effect was reported. This is one of several reports received from the same reporter. Additional information has been requested.
Sex: U
Vaccine: HPV9
Symptoms: Interchange of vaccine products, No adverse event
Clinical narrative: This spontaneous report as received from a healthcare worker refers to a patient of unknown age and gender. The patient's pertinent medical history and concomitant medication were not reported. On 15-APR-2015, the patient was vaccinated with the first dose of GARDASIL (lot# K007828, expiry date 02-MAR-2017, dose and route of administration not reported). On 29-JUN-2015, the patient was inadvertently vaccinated with a 0.5 ml dose of GARDASIL 9 (lot# K026247, expiry date 29-JAN-2017, intramuscularly) instead of a second dose of GARDASIL. No adverse effects were reported. Additional information has been requested.
Age: 58.0
Sex: M
Vaccine: HEP
Symptoms: No adverse event, Underdose
Clinical narrative: This spontaneous report as received from a nurse refers to a 58 year old male patient. The patient's concurrent conditions and medical history were not reported. On 18-MAY-2015, the patient received an adult dose of RECOMBIVAX HB lot # K021581 (unknown strength and route) but on 15-JUN-2015, the patient was vaccinated with pediatric dose of RECOMBIVAX HB lot # J013394 in error, as his second dose of his Hepatitis B vaccination series. Concomitant medications were not reported. The patient did not experience any adverse effects. The outcome of the event was unknown. There was no product quality complaint involved. 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 healthcare worker refers to a patient of unknown age and unknown gender. On 29-MAY-2015, the patient was vaccinated with 0.5 ml of improperly stored VARIVAX (Merck) (lot# L001334 and expiry date: 13-JAN-2017) once subcutaneously. No adverse effects were reported. No product quality complaint was reported for VARIVAX (Merck). This is one of the several reports from the same reporter. Additional information has been requested.
Age: 1.59
Sex: U
Vaccine: HIBV
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: Information has been received from a Registered Nurse referring to a 19 month old patient of unknown gender. Information about patient's concurrent conditions and medical history was not reported. On 25-JUN-2015 the patient was vaccinated with a dose of improperly stored PEDVAXHIB (route not reported, lot # reported as K026532, dose 0.5 (unit not provided). Concomitant medications were not provided. No adverse effect was reported. This is one of several reports received from the same reporter. Additional information has been requested.
Age: 1.44
Sex: U
Vaccine: HIBV
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: Information has been received from a Registered Nurse referring to a 17 month old patient of unknown gender. Information about patient's concurrent conditions and medical history was not reported. On 24-JUN-2015 the patient was vaccinated with a dose of improperly stored PEDVAXHIB (route not reported, lot # reported as K026532, dose 0.5 (unit not provided). Concomitant medications were not provided. 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: Expired product administered, No adverse event
Clinical narrative: This spontaneous report as received from a licensed practical nurse refers to a patient of unknown demographics. The concurrent condition, medical history and concomitant medication was not reported. On 01-JUL-2015 the patient was inadvertently vaccinated with VARIVAX (Merck) which was expired on 30-JUN-2015. No adverse effects was reported. Additional information has been requested.
Age: 14.0
Sex: F
Vaccine: HEP, HEPA
Symptoms: Headache, Overdose
Clinical narrative: This spontaneous report was received from a physician refers to a 14 year old female patient with immunodeficiency, asthma and migraine headaches. The patient's medical history included hives with amoxicillin and CEFZIL. On 28-MAY-2015, the patient was vaccinated with VAQTA (lot # K014696, 1 ml, intramuscular) and RECOMBIVAX HB (lot# K020336, 1 ml, intramuscular), the patient was given adult dose of vaccines instead of pediatric doses (overdose). Concomitant therapies included XOLAIR. On an unknown date in 2015, post vaccination, the patient experienced headache and possible lethargy. No lab diagnostic studies were performed. Ibuprofen was given as the treatment for the event. The outcome of thee vents was unknown. The causal relationship between the events and suspect therapies was not reported. Additional information has been requested.
Age: 0.62
Sex: U
Vaccine: HIBV
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: Information has been received from a Registered Nurse referring to a 7 month old patient of unknown gender. Information about patient's concurrent conditions and medical history was not reported. On 25-JUN-2015 the patient was vaccinated with a dose of improperly stored PEDVAXHIB (route not reported, lot # K026532, dose 0.5 (unit not provided). Concomitant medications were not provided. No adverse effect was reported. This is one of several reports received from the same reporter. Additional information has been requested.
Age: 0.31
Sex: U
Vaccine: HIBV
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: Information has been received from a Registered Nurse referring to a 3 month old patient of unknown gender. Information about patient's concurrent conditions and medical history was not reported. On 22-JUN-2015 the patient was vaccinated with a dose of improperly stored PEDVAXHIB (route not reported, lot # reported as K025004, dose 0.5(unit not provided). Concomitant medications were not provided. 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 product storage, No adverse event
Clinical narrative: This spontaneous report was received from a nurse and refers to a patient of an unknown age and gender. No information about patient's concomitant medication, pertinent medical history and drug reactions or allergies was provided. On 17-JUN-2015, the patient was vaccinated with an improperly stored VARIVAX (Merck) 0.5ml/once, subcutaneously, lot# K006135, expiration date: 29-APR-2015. No adverse effects were reported. Additional information has been requested.
Age: 60.0
Sex: M
Vaccine: VARZOS
Symptoms: Skin discolouration
Clinical narrative: This spontaneous report as received from a pharmacist refers to a 60 year old male patient. The patient's medical history was not specified. On 30-JUN-2015, the patient was vaccinated with a dose of ZOSTAVAX, (lot #, dose and site of administration were not reported) subcutaneously. In approximately 2015 (reported as after receiving ZOSTAVAX), the patient's arm turned brown down to his elbow. The patient called pharmacist. The outcome of skin discolouration was reported as not recovered/not resolved. The relatedness between the event and ZOSTAVAX was not reported. 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 healthcare worker refers to an unspecified patients of unknown age. The patient's medical history, concurrent conditions and concomitant medications were not reported. On an unknown date, the patients were vaccinated with improperly stored ROTATEQ, (lot #, dose and frequency were unknown). No adverse effects reported. The outcome of the events was unknown. No product quality complaint (PQC) was involved. No further information was provided. This is one of several reports received from the same reporter. Additional information has been requested.
Age: 0.52
Sex: U
Vaccine: HIBV
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: Information has been received from a Registered Nurse referring to a 6 month old patient of unknown gender. Information about patient's concurrent conditions and medical history was not reported. On 23-JUN-2015 the patient was vaccinated with a dose of improperly stored PEDVAXHIB (route not reported, lot # reported as K025004, dose 0.5 (unit not provided). Concomitant medications were not provided. No adverse effect was reported. This is one of several reports received from the same reporter. Additional information has been requested.
Sex: U
Vaccine: HEP, RV5
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report was received from a nurse and refers to a patient of unknown age and gender. The patient's medical history, concurrent conditions, drug reactions and allergies were not reported. On 30-JUN-2015 the patient was vaccinated with improperly stored ROTATEQ (dose, lot# and expiration date were not reported; route of administration defaulted to oral) and RECOMBIVAX HB (dose, anatomical location, route of administration, lot# and expiration date were not reported). No adverse events were reported. This is one of the two reports received from the same source. 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 nurse and refers to 2 patients of unknown age and gender. The patients' medical history, concurrent conditions, drug reactions and allergies were not reported. on 30-JUN-2015 the patients were vaccinated with improperly stored GARDASIL (dose, route of administration, anatomical location, lot# and expiration date were not reported). No adverse events were reported. This is one of the two reports received from the same source. Additional information has been requested.
Age: 1.08
Sex: U
Vaccine: HIBV
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: Information has been received from a Registered Nurse referring to a 12 month old patient of unknown gender. Information about patient's concurrent conditions and medical history was not reported. On 20-JUN-2015 the patient was vaccinated with a dose of improperly stored PEDVAXHIB (route not reported, lot # reported as K025004, dose 0.5 (unit not provided). Concomitant medications were not provided. No adverse effect was 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 nurse and refers to an unspecified number of patients of unknown age and gender. No information about patients concomitant medication, pertinent medical history, drug reactions or allergies was provided. On an unspecified dates, an unspecified number of patients received improperly stored GARDASIL lot# J009243, exp. date: 23-APR-2016 and lot# K011562, exp. date: 08-APR-2017 (dose, frequency and route of administration not reported). No adverse effects were reported. This is one of several reports from the same reporter. Additional information has been requested.
Age: 0.17
Sex: U
Vaccine: HIBV
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: Information has been received from a Registered Nurse referring to a 8 week old patient of unknown gender. Information about patient's concurrent conditions and medical history was not reported. On 24-JUN-2015 the patient was vaccinated with a dose of improperly stored PEDVAXHIB (route not reported, lot # reported as K025004, dose 0.5 (unit not provided). Concomitant medications were not provided. 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 product storage, No adverse event
Clinical narrative: This spontaneous report as received from a registered nurse refers to an unknown number of patients of unknown age and gender. No information on their medical histories, concurrent conditions or concomitant drugs was provided. On an unknown date, the patients were inadvertently vaccinated with doses of improperly stored VARIVAX (Merck) (dose and route of administration were not reported), lot # L000454 with expiry date 06-JAN-2017, and lot # K021485 with expiry date 03-NOV-2016. No adverse effects were reported. This is one of several reports received from the same reporter. Additional information has been requested.
Age: 0.51
Sex: U
Vaccine: HIBV
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: Information has been received from a Registered Nurse referring to a 6 month old patient of unknown gender. Information about patient's concurrent conditions and medical history was not reported. On 23-JUN-2015 the patient was vaccinated with a dose of improperly stored PEDVAXHIB (route not reported, lot # reported as K025004, dose 0.5 (unit not provided). Concomitant medications were not provided. 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 product storage, No adverse event
Clinical narrative: This spontaneous report was received from a nurse and refers to an unspecified number of patients of unknown age and gender. No information about patients concomitant medication, pertinent medical history, drug reactions or allergies was provided. On an unspecified dates, an unspecified patients received improperly stored VARIVAX (Merck) lot # K010337, exp. date: 22-JUL-2016; lot# K021485, exp. date: 03-NOV-2016 and lot# L006386, exp. 25-FEB-2017 (dose, frequency and route of administration not reported). No adverse effects were reported. This is one of several reports from the same reporter. Additional information has been requested.
Age: 1.34
Sex: U
Vaccine: HIBV
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: Information has been received from a Registered Nurse referring to a 16 month old patient of unknown gender. Information about patient's concurrent conditions and medical history was not reported. On 22-JUN-2015 the patient was vaccinated with a dose of improperly stored PEDVAXHIB (route not reported, lot # reported as K025004, dose 0.5 (unit not provided). Concomitant medications were not provided. No adverse effect was reported. This is one of several reports received from the same reporter. Additional information has been requested.
Sex: U
Vaccine: VARZOS
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report was received from a licensed vocational nurse refers to multiple unspecified patients of unknown age and gender. The patients' pertinent medical history and concurrent conditions were not provided. On an unknown date, the patients were vaccinated with doses of ZOSTAVAX (route, lot numbers and expiration dates were not provided). On an unknown date, there was incorrect product storage as multiple unspecified patients had received ZOSTAVAX that were improperly stored. No adverse event were reported. It was unknown if the patients sought medical attention. At the time of the report, the patients' status was unknown. Additional information has been requested.
Sex: U
Vaccine: VARCEL
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report was received from a licensed vocational nurse refers to multiple unspecified patients of unknown age and gender. The patients' pertinent medical history and concurrent conditions were not provided. On an unknown date, the patients were vaccinated with doses of VARIVAX (Merck) (route, lot numbers and expiration dates were not provided). On an unknown date, there was incorrect product storage as multiple unspecified patients had received VARIVAX (Merck) that were improperly stored. No adverse event were reported. It was unknown if the patients sought medical attention. At the time of the report, the patient's status was unknown. Additional information has been requested. This is one of several reports received from the same source.
Age: 0.15
Sex: U
Vaccine: HIBV
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: Information has been received from a Registered Nurse referring to an 8 weeks old patient of unknown gender. Information about patient's concurrent conditions and medical history was not reported. On 19-JUN-2015 the patient was vaccinated with a dose of improperly stored PEDVAXHIB (route not reported, lot # K025002 with expiration date 20-JUL-2017, dose 0.5 (unit not reported). Concomitant medications were not provided. No adverse effect was reported. This is one of several reports received from the same reporter. Additional information has been requested.
Age: 0.18
Sex: U
Vaccine: HIBV
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: Information has been received from a Registered Nurse referring to a 9 week old patient of unknown gender. Information about patient's concurrent conditions and medical history was not reported. On 22-JUN-2015 the patient was vaccinated with a dose of improperly stored PEDVAXHIB (route not reported, lot # reported as K025002, dose 0.5 (unit not provided). Concomitant medications were not provided. No adverse effect was reported. This is one of several reports received from the same reporter. Additional information has been requested.
Age: 1.34
Sex: U
Vaccine: HIBV
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: Information has been received from a Registered Nurse referring to a 16 month old patient of unknown gender. Information about patient's concurrent conditions and medical history was not reported. On 19-JUN-2015 the patient was vaccinated with a dose of improperly stored PEDVAXHIB (route not reported, lot # K025002 with expiration date 20-JUL-2017, dose 0.5 (unit not provided). Concomitant medications were not provided. No adverse effect was reported. This is one of several reports received from the same reporter. Additional information has been requested.
Age: 2.0
Sex: U
Vaccine: HIBV
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: Information has been received from a Registered Nurse referring to a 2 year old patient of unknown gender. Information about patient's concurrent conditions and medical history was not reported. On 19-JUN-2015 the patient was vaccinated with a dose of improperly stored PEDVAXHIB (route not reported, lot # K025002 with expiration date 20-JUL-2017, dose 0.5 (unit not provided). Concomitant medications were not provided. No adverse effect was reported. This is one of several reports received from the same reporter. Additional information has been requested.
Age: 0.2
Sex: U
Vaccine: HIBV
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: Information has been received from a Registered Nurse referring to a 10 week old patient of unknown gender. Information about patient's concurrent conditions and medical history was not reported. On 19-JUN-2015 the patient was vaccinated with a dose of improperly stored PEDVAXHIB (route not reported, lot # K025002 with expiration date 20-JUL-2017, dose 0.5 (unit not provided). Concomitant medications were not provided. No adverse effect was reported. This is one of several reports received from the same reporter. Additional information has been requested.
Age: 0.17
Sex: M
Vaccine: DTAP
Symptoms: Abnormal behaviour, Agitation, Crying, Decreased appetite, Decreased eye contact
Clinical narrative: 6/25 baby drowsy all day. From 6/25 on, previous advanced behaviors of engagement all muted or subdued, more upset and more often, new high-pitched, screaming cry, inconsolable, no warm up or cool down cry, like an on/off switch from not upset to upset and vice versa, when upset level of agitation much higher, loss of hunger cues, no rolling over (had in previous days), not using arms and legs while on belly (had in previous days), less eye contact, less facial expressions engaging with parents, less talking/making sounds, 90% decrease in verbalizing, fitful sleeping, feedings interrupted by crying (had not previously), aggressively sucking or looking for feeding, upset during diaper changes (changing table was previously one of his favorite places, now is one of his least favorite places).  7/1 around 4AM seizure. 7/2 around 4:30AM seizure.
Age: 0.17
Sex: M
Vaccine: DTAP
Symptoms: Feeding disorder, Flat affect, Mood altered, Screaming, Seizure
Clinical narrative: 6/25 baby drowsy all day. From 6/25 on, previous advanced behaviors of engagement all muted or subdued, more upset and more often, new high-pitched, screaming cry, inconsolable, no warm up or cool down cry, like an on/off switch from not upset to upset and vice versa, when upset level of agitation much higher, loss of hunger cues, no rolling over (had in previous days), not using arms and legs while on belly (had in previous days), less eye contact, less facial expressions engaging with parents, less talking/making sounds, 90% decrease in verbalizing, fitful sleeping, feedings interrupted by crying (had not previously), aggressively sucking or looking for feeding, upset during diaper changes (changing table was previously one of his favorite places, now is one of his least favorite places).  7/1 around 4AM seizure. 7/2 around 4:30AM seizure.
Age: 0.17
Sex: M
Vaccine: DTAP
Symptoms: Somnolence
Clinical narrative: 6/25 baby drowsy all day. From 6/25 on, previous advanced behaviors of engagement all muted or subdued, more upset and more often, new high-pitched, screaming cry, inconsolable, no warm up or cool down cry, like an on/off switch from not upset to upset and vice versa, when upset level of agitation much higher, loss of hunger cues, no rolling over (had in previous days), not using arms and legs while on belly (had in previous days), less eye contact, less facial expressions engaging with parents, less talking/making sounds, 90% decrease in verbalizing, fitful sleeping, feedings interrupted by crying (had not previously), aggressively sucking or looking for feeding, upset during diaper changes (changing table was previously one of his favorite places, now is one of his least favorite places).  7/1 around 4AM seizure. 7/2 around 4:30AM seizure.
Age: 35.0
Sex: F
Vaccine: PPV
Symptoms: Computerised tomogram abnormal, Musculoskeletal pain, Oedema, Swelling
Clinical narrative: Shoulder pain and swelling, CT revealed edema and air bubble, no necrotizing fascitis.
Age: 74.0
Sex: F
Vaccine: PNC13
Symptoms: Injection site erythema, Injection site pain
Clinical narrative: Pt reports her arm is sore and skin is red from above injection site down to the elbow.
Age: 65.0
Sex: F
Vaccine: PPV
Symptoms: Dyspnoea, Injection site erythema, Injection site pain, Pyrexia, Rash
Clinical narrative: Rash on hands and arms. Redness, soreness, and tenderness around the area where vaccine was administered. Shortness of breath, drowsiness, and fever for 3 days. On the 3rd day my 2 youngest daughters gave me homeopathic pills to detox from vaccine toxins and do TERRA essential oils to ingest and rub for detoxifying.
Age: 65.0
Sex: F
Vaccine: PPV
Symptoms: Somnolence
Clinical narrative: Rash on hands and arms. Redness, soreness, and tenderness around the area where vaccine was administered. Shortness of breath, drowsiness, and fever for 3 days. On the 3rd day my 2 youngest daughters gave me homeopathic pills to detox from vaccine toxins and do TERRA essential oils to ingest and rub for detoxifying.
Age: 52.0
Sex: F
Vaccine: TDAP
Symptoms: Injection site erythema, Injection site swelling, Injection site warmth
Clinical narrative: Upper left arm red, warm, swollen area 10.5cm.
Sex: U
Vaccine: HEP
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report was received from a healthcare worker refers to a patient of unknown age and gender. Concurrent conditions, medical history and allergies were not reported. On 29-JUN-2015, the patient was vaccinated with a dose of RECOMBIVAX HIB, 2.5 microgram/0.5 ml (dose, frequency, route, anatomical location, lot number and expiration date were not reported), which was improperly storage. No adverse events were reported. 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 healthcare worker regarding unspecified patients of unknown age. The patients concurrent conditions, medical history and concomitant medications were not reported. Since 06-MAY-2015, unspecified number of patients were vaccinated with a dose of ROTATEQ (Lot # K010224, expiry date 13-MAY-2016) which was exposed to a temperature outside of the recommended range. 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 healthcare worker regarding unspecified patients of unknown age. The patients concurrent conditions, medical history and concomitant medications were not reported. Since 06-MAY-2015, unspecified number of patients were vaccinated with a dose of GARDASIL (Lot # K005083, expiry date 04-NOV-2016; or Lot # K006960, expiry date 19-FEB-2017) which were exposed to a temperature outside of the recommended range. No adverse effects were reported. 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 was received from a healthcare worker and refers to unspecified patients of unknown age and gender. Concurrent conditions, medical history and allergies were not reported. On an unknown date, the unspecified patients were vaccinated with doses of (Oka/Merck) VARIVAX (strength, dose, frequency, route and anatomical location were not reported), (lot # L001335 with expiration date: 13-JAN-2017 and lot # L006384 with expiration date: 25-FEB-2017), which were improperly storage. No adverse events were reported. Additional information has been requested.
Age: 59.0
Sex: F
Vaccine: PPV
Symptoms: Erythema, Pain in extremity, Peripheral swelling, Skin warm
Clinical narrative: This spontaneous report was received from a pharmacist refers to a 59 year old female patient. The patient's medical history and concurrent conditions were not reported. On 18-JUN-2015, the patient was vaccinated with a dose of PNEUMOVAX 23 (lot # K009874, expiration date: 19-MAR-2016, 0.5 ml, intramuscular). Concomitant medications included unspecified blood pressure and thyroid medications. On an unknown date in June 2015, 3 hours after receiving vaccine, the patient experienced significant swelling of the right arm. The reporter also stated that the patient's right arm was significantly swollen, red and warm to touch from the elbow to the shoulder and the patient felt painful to lift her arm. The patient had been treating her arm at home with ice. The patient sought medical attention by visiting pharmacy and pharmacist prescribed unspecified dose of TYLENOL on an unspecified date for pain. The outcome of the events was reported as not recovered/not resolved. The causal relationship between the events and PNEUMOVAX 23. No further information was provided. Additional information has been requested.
Age: 25.0
Sex: F
Vaccine: HPV4
Symptoms: Incomplete course of vaccination
Clinical narrative: This spontaneous report was received from a consumer regarding her 25 year old daughter. The patient's medical history, concurrent conditions and concomitant medications were not reported. On an unknown in 2009, the patient was vaccinated with GARDASIL. The reporter stated that her daughter did not complete immunization series of GARDASIL. She inquired if she can finish or restart series since she is not yet 26 years. Additional information is not expected as the reporter contact details were not provided.
Age: 60.0
Sex: F
Vaccine: VARZOS
Symptoms: Malaise, Pruritus, Rash pustular, Skin burning sensation
Clinical narrative: This spontaneous report was received from a 60 year old female patient regarding herself. The patient's medical history was not reported. The patient's concurrent conditions included allergy to ampicillin, neosporin oils and baby oil. On an unknown date in 2011, the patient was vaccinated with ZOSTAVAX (Lot number, dose and route were not reported). Concomitant medications included unspecified hormone medicines. On an unknown date in 2011, after receiving the shot she did not feel well, a few hours later she noticed white bumps with pus-like liquid on her face that were burning and itching. The patient recovered from the events after few days. The reporter did not provide the relatedness of the events with ZOSTAVAX. Additional information has been requested.
Sex: F
Vaccine: HPV4
Symptoms: Expired product administered, No adverse event
Clinical narrative: This spontaneous report was received from a pharmacist refers to a female patient of unknown age. The patient's medical history and concurrent conditions were not reported. On 19-JUN-2015, the patient was vaccinated with expired dose of GARDASIL (0.5 ml, intramuscular, lot# 0963AA, expiry date: 09-NOV-2013) (expired product administered). The vaccine was never undergone any temperature excursions (incorrect product storage). Concomitant medications were unspecified by reported. No adverse event was reported. The outcome of the events was unknown. No further information was provided. Additional information has been requested.
Sex: U
Vaccine: VARCEL
Symptoms: Expired product administered, No adverse event
Clinical narrative: This spontaneous report was received from a nurse refers to a patient of unknown age and gender. Concurrent conditions, medical history and allergies were not reported. ON 12-JUN-2015, the patient was vaccinated with a dose of (Oka/Merck) VARIVAX, (strength, dose, frequency, anatomical location and lot number were not reported), subcutaneously, which had expired on 23-MAY-2015. It was also reported that it was supported. No adverse events were reported. Additional information has been requested.
Age: 24.0
Sex: F
Vaccine: HPV4
Symptoms: Fatigue, Headache, Trismus
Clinical narrative: This spontaneous report was received from a physician assistant refers to a currently 24 years old no pregnant female patient without pertinent medical history. Drug reactions include dizziness and palpitations with codeine (date unknown). On 05-MAY-2015, the patient was vaccinated with the first dose of GARDASIL, strength reported as 120 Y, (dose, route and anatomical location were not reported), (lot # K011138 with expiration date: 08-APR-2017). Concomitant therapies included hormonal contraceptives (unspecified) described as birth control pill. On an unknown date 2015 after the vaccination with GARDASIL, the patient experienced trismus described as "lock jaw like symptoms", fatigue and headache. The patient sought medical attention through seeing the physician assistant on an unknown date. It was unspecified if treatment was given for the adverse events and there was no laboratory diagnostics studies performed. The outcome of trismus, fatigue and headache was reported as recovered/resolved on an unknown date in 2015. The relatedness between trismus, fatigue and headache and therapy with GARDASIL was not reported. Additional information has been requested.
Sex: F
Vaccine: VARZOS
Symptoms: Herpes zoster
Clinical narrative: This spontaneous report was received from a physician via a company representative regarding to a female patient of an unknown age. The patient's concurrent conditions and medical history were not reported. On an unknown date the patient was vaccinated with ZOSTAVAX (lot #, dose and route were not reported). On an unknown date in June 2015 (reported as last week), the patient was diagnosed with shingles. The patient was referred to an unknown physician for treatment. The outcome of shingles was unknown.  The reporter did not provide the relatedness of shingles with ZOSTAVAX. Additional information has been requested.
Age: 34.0
Sex: F
Vaccine: VARCEL
Symptoms: Burning sensation, Erythema, Pain, Pruritus, Skin warm
Clinical narrative: Swelling, Burning, Itching, Warm to the touch, Pain when it's touched or any pressure get put onto it, redness at a big size on my arm.
Age: 34.0
Sex: F
Vaccine: VARCEL
Symptoms: Swelling
Clinical narrative: Swelling, Burning, Itching, Warm to the touch, Pain when it's touched or any pressure get put onto it, redness at a big size on my arm.
Age: 10.0
Sex: F
Vaccine: TDAP
Symptoms: Injection site pain, Injection site swelling, Lip swelling
Clinical narrative: Swelling of upper and lower lips; swelling and soreness L upper arm.
Age: 62.0
Sex: F
Vaccine: VARZOS
Symptoms: Dizziness, Injection site erythema, Injection site pruritus, Injection site reaction, Injection site warmth
Clinical narrative: Momentarily dizzy then large itching, red and hot welt at injection site 6-7 inches long and 4 inches wide that increased over two days to 11 inches long and 6 inches wide with redness, heat and itching.
Age: 62.0
Sex: F
Vaccine: VARZOS
Symptoms: Urticaria
Clinical narrative: Momentarily dizzy then large itching, red and hot welt at injection site 6-7 inches long and 4 inches wide that increased over two days to 11 inches long and 6 inches wide with redness, heat and itching.
Age: 71.0
Sex: M
Vaccine: VARZOS
Symptoms: Pain, Rash pruritic, Rash vesicular
Clinical narrative: Rash on back similar to shingles rash, subsided after couple weeks, but itchiness and pain remains still today.  Patient is still taking gabapentin for the pain.
Age: 47.0
Sex: F
Vaccine: TDAP
Symptoms: Injection site pain, Neck pain, Pain, Pain in extremity
Clinical narrative: Donor called on 7/5/15 at 10:30 AM to report tenderness at site of injection of tetanus, received on 6/24/15. She also reported pain in the deltoid muscle on trying to raise her arm and pain radiating to L neck. The symptoms have been present for 10 days.
Age: 51.0
Sex: M
Vaccine: VARZOS
Symptoms: Injection site vesicles
Clinical narrative: Clear vesicle formed at site of injection and subsequently ruptured, leaving a 2cm denuded area akin to a burn.
Age: 72.0
Sex: F
Vaccine: PPV
Symptoms: Arthralgia, Chills, Tremor
Clinical narrative: SHIVERS, UNCONTROLLABLE SHAKING AND JOINT PAIN.
Age: 70.0
Sex: F
Vaccine: FLUX
Symptoms: Mobility decreased
Clinical narrative: Reduce use of lower limbs.
Age: 20.0
Sex: M
Vaccine: MENB
Symptoms: Injection site erythema, Throat irritation
Clinical narrative: Itchy throat, red band around the arm where the shot was given, redness from elbow to shoulder. Had to take prednisone and Keflex.
Age: 1.02
Sex: F
Vaccine: FLUX, HEPA, VARCEL
Symptoms: Computerised tomogram, Cytogenetic analysis, Electroencephalogram, Epilepsy, Fall
Clinical narrative: Staring, spacing off, falling down often. Took to emergency room in March of 2011 for falling, several visits to family Dr, diagnosed with epilepsy in June 2011. Treated with several different types of seizure medications and vagal nerve stimulator.
Age: 1.02
Sex: F
Vaccine: FLUX, HEPA, VARCEL
Symptoms: Feeling abnormal, Nuclear magnetic resonance imaging, Staring
Clinical narrative: Staring, spacing off, falling down often. Took to emergency room in March of 2011 for falling, several visits to family Dr, diagnosed with epilepsy in June 2011. Treated with several different types of seizure medications and vagal nerve stimulator.
Age: 50.0
Sex: F
Vaccine: TDAP
Symptoms: Chills, Dizziness, Pain, Peripheral swelling, Swelling
Clinical narrative: Had swelling and pain from 7/1 to 7/2 but was able to deal with it, on 7/2 7pm I started getting chills and body aches. The arm was also swollen and more tender. I could not go to work due to the body aches and dizziness started on 7/3 which ended late on 7/4.
Age: 50.0
Sex: F
Vaccine: TDAP
Symptoms: Tenderness
Clinical narrative: Had swelling and pain from 7/1 to 7/2 but was able to deal with it, on 7/2 7pm I started getting chills and body aches. The arm was also swollen and more tender. I could not go to work due to the body aches and dizziness started on 7/3 which ended late on 7/4.
Age: 71.0
Sex: F
Vaccine: PPV, TDAP
Symptoms: Chest X-ray, Nuclear magnetic resonance imaging, Pain, Pneumonia, Ultrasound scan
Clinical narrative: Sore pain when lifting or driving also got pneumonia.
Age: 28.0
Sex: F
Vaccine: TDAP, TD
Symptoms: Exposure during pregnancy, No adverse event
Clinical narrative: None.
Age: 28.0
Sex: F
Vaccine: TDAP, TD
Symptoms: Exposure during pregnancy
Clinical narrative: None.
Age: 11.0
Sex: F
Vaccine: MNQ, TDAP, MNQ, TDAP
Symptoms: Erythema, Peripheral swelling, Rash, Skin warm
Clinical narrative: This case was reported by a pharmacist via call center representative and described the occurrence of rash in a 11-year-old female patient who received BOOSTRIX (batch number NL7K3, expiry date 15th September 2017). Co-suspect products included MENVEO (batch number M14080, expiry date unknown). On 23rd June 2015, the patient received BOOSTRIX (intramuscular) and MENVEO. In June 2015, less than a week after receiving BOOSTRIX, the patient experienced rash (serious criteria clinically significant/intervention required), swelling arm, erythema, red throat and swallowing difficult. On an unknown date, the outcome of the rash, swelling arm, erythema, red throat and swallowing difficult were unknown. The reporter considered the rash, swelling arm, erythema, red throat and swallowing difficult to be possibly related to BOOSTRIX. Additional information was provided: The patient experienced swelling and redness on the arm where BOOSTRIX was administered.
Age: 11.0
Sex: F
Vaccine: MNQ, TDAP, MNQ, TDAP
Symptoms: Dysphagia, Erythema, Peripheral swelling, Pharyngeal erythema, Rash
Clinical narrative: This case was reported by a pharmacist via call center representative and described the occurrence of rash in a 11-year-old female patient who received BOOSTRIX (batch number NL7K3, expiry date 15th September 2017). Co-suspect products included MENVEO (batch number M14080, expiry date unknown). On 23rd June 2015, the patient received BOOSTRIX (intramuscular) and MENVEO. In June 2015, less than a week after receiving BOOSTRIX, the patient experienced rash (serious criteria clinically significant/intervention required), swelling arm, erythema, red throat and swallowing difficult. On an unknown date, the outcome of the rash, swelling arm, erythema, red throat and swallowing difficult were unknown. The reporter considered the rash, swelling arm, erythema, red throat and swallowing difficult to be possibly related to BOOSTRIX. Additional information was provided: The patient experienced swelling and redness on the arm where BOOSTRIX was administered.
Age: 16.0
Sex: F
Vaccine: HPV4
Symptoms: Amnesia, Arthralgia, Asthenia, Computerised tomogram, Fatigue
Clinical narrative: Seizures, joint pain, memory loss, weakness, prolonged sleep, fatigue.
Age: 16.0
Sex: F
Vaccine: HPV4
Symptoms: Laboratory test, Lumbar puncture, Nuclear magnetic resonance imaging, Seizure, Somnolence
Clinical narrative: Seizures, joint pain, memory loss, weakness, prolonged sleep, fatigue.
Age: 1.09
Sex: F
Vaccine: MMR, PNC13
Symptoms: Expired product administered, No adverse event
Clinical narrative: Child administered an expired dose of PCV. Drug expired 01/31/2015, dose given 03/12/2015. No adverse reaction reported to Health Dept. Error found during routine audit.
Age: 19.0
Sex: F
Vaccine: HEP
Symptoms: Angioedema, Gingival pain, Gingival swelling, Nausea, Vomiting
Clinical narrative: Swollen and painful gum lines. full facial angioedema, nausea, vomiting.
Age: 17.0
Sex: M
Vaccine: TYP, YF
Symptoms: Pruritus, Urticaria
Clinical narrative: Itching, very large hives on arms, legs, back, front torso.