chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Sex: U
Vaccine: HPV4
Symptoms: Expired product administered, Incorrect product storage
Clinical narrative: This spontaneous report was received from a nurse and refers to unspecified number of patients of unknown age and gender. There was no information about patients' pertinent medical histories, drug reactions or allergies provided. On an unknown date since 08-SEP-2015, the patients were vaccinated with improperly stored and expired 2 doses of GARDASIL (lot# K010574, expiration date 08-APR-2015, dose, anatomical location and route of vaccination were not reported). Additional information has been requested.
Age: 65.0
Sex: F
Vaccine: PNC13
Symptoms: Cellulitis, Erythema, Peripheral swelling, Skin warm
Clinical narrative: Vaccination given by RN. Right arm upper tricep area with erythematous caused cellulitis 6 x 3 cm warm to touch.
Age: 12.0
Sex: U
Vaccine: HPV9
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: Information has been received from a registered nurse referring to a 12 year old patient of unknown gender. On 07-AUG-2015 the patient was vaccinated with GARDASIL 9 (lot # L014415, intramuscular, expiration date and dose were unknown) which excursed the storage temperature (incorrect product storage). No reaction was reported. This is one of several reports received from the same reporter. Additional information has been requested.
Age: 24.0
Sex: U
Vaccine: HPV9
Symptoms: Urticaria
Clinical narrative: Pt c/o urticaria, hives intermittent starting few days after receiving vaccine. Pt states her hives are gone today.
Sex: U
Vaccine: HEP
Symptoms: Incorrect product storage
Clinical narrative: Information has been received from a pharmacist referring to 3 newborns. Background: Since June 2015, there had been 1645 times (30 minutes each time= 822.5 hours) that the temperature dropped below 36F. Of course, there was 144 times (30 minutes each time=72 hours) that temperature was below 32F, the lowest being 29.7F. On 04-JUL-2015, there was a low temperature of 30.2F. On 16-SEP-2015 the patients were vaccinated with the improperly stored RECOMBIVAX HB strength 2.5/0.5 (units not provided) (lot number K020216 and expiration date of 17-SEP-2016) (dose and route of administration were not reported). There was no product quality complaint (PQC). This is one of several reports received from the same reporter. Additional information has been requested.
Sex: U
Vaccine: VARZOS
Symptoms: No adverse event, Product quality issue
Clinical narrative: Information has been received from a pharmacist referring to a patient of unknown age and gender. There was no medical history or drug reaction/allergies reported. On an unknown date, a patient missed a dose of ZOSTAVAX (lot# was reported as L023236 with expired date 10-MAR-2018, dose and route were unknown) since the diluent vial from the ZOSTAVAX package was broken. A product quality complaint (PQC) had been filed for this defect. No concomitant medication was provided. No adverse effects were reported. Lot number L023236 is an invalid lot number for ZOSTAVAX. Additional information has been requested.
Sex: U
Vaccine: HEP
Symptoms: Reaction to preservatives
Clinical narrative: This initial spontaneous report was received from a registered nurse referring to a patient of unknown age and gender. There was no pertinent medical history, concurrent conditions or drug allergies/drug reactions described. It was reported that on an unknown date, the patient had an unspecified reaction to thimerosal content in an unspecified vaccine administered on an unknown date. As potentially suspect the vaccine administered could be RECOMBIVAX HB (dose, frequency, route and lot# were not reported). It was unknown if the patient sought medical attention. Product quality complaint (PQC) was not involved. At the time of the report, the outcome of the unspecified reaction was unknown. Additional information is not expected as the reporter did not wish further contact.
Age: 11.0
Sex: U
Vaccine: HPV9
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: Information has been received from a registered nurse referring to an 11 year old patient of unknown gender. On 07-AUG-2015 the patient was vaccinated with GARDASIL 9 (lot # L014415, intramuscular, expiration date and dose were unknown) which excursed the storage temperature (incorrect product storage). No reaction 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 registered nurse referring to a patient of unknown age and gender. Patient's medical history and concurrent conditions were not reported. On 14-SEP-2015, the patient was vaccinated with an improperly stored dose of ZOSTAVAX, (lot# reported as 1012475, expiry date 10-JUL-2016. No adverse effects were reported. Additional information has been requested. Lot # 1012475 is an invalid lot # for ZOSTAVAX.
Age: 14.0
Sex: M
Vaccine: HPV9
Symptoms: Cold sweat, Dizziness, Immediate post-injection reaction, Nausea
Clinical narrative: Patient stated he was feeling dizzy, nauseous and clammy immediately after the injection, 15 minutes after the injection patient was taken back to the examination room - observed for another 15 minutes. Vitals were all good. Evaluated by Dr before being discharged.
Sex: U
Vaccine: HEP
Symptoms: Incorrect product storage
Clinical narrative: Information has been received from a pharmacist referring to 4 newborns (numbered 190, 191, 192 and 193). Background: Since June 2015, there had been 1645 times (30 minutes each time=822.5 hours) that the temperatures dropped below 36F. Of course, there was 144 times (30 minutes each time=72 hours) that temperatures was below 32F, the lowest being 29.7F. On 04-JUL-2015, there was a low temperature of 30.2F. On 15-SEP-2015 the patients were vaccinated with the improperly stored RECOMBIVAX HB strength 2.5/0.5 (units not provided) (lot number K020216 and expiration date of 17-SEP-2016) (dose and route of administration were not reported). There was no product quality complaint (PQC). This is one of several reports received from the same reporter. Additional information has been requested.
Age: 68.0
Sex: F
Vaccine: PPV
Symptoms: Chills, Influenza like illness, Injected limb mobility decreased, Injection site haemorrhage, Pain in extremity
Clinical narrative: Information has been received from a 68 year old female patient with lymphedema and emphysema referring to herself. The patient was allergic to "CLE+". In 2005, the patient was vaccinated with one dose of pneumococcal vaccine (unspecified) (dose and route unknown). On 03-OCT-2015, the patient was vaccinated with another dose of PNEUMOVAX 23 (dose and route unknown, in the right shoulder) at her local drug store, without consulting her physician. Concomitant medications were unspecified. On 04-OCT-2015 (reported as "the following day"), the patient began to experience chills and flu-like symptoms. When she removed her bandage, it was "full of blood", and an unspecified amount of time later, her arm began to swell below the injection site. Her arm was sore to touch. She also stated she could not lift her right arm to put on her coat. At the time of report, the patient did not seek any medical attention. No treatment was given for the events. Her chills had resolved. The outcome of other events was reported as recovering/resolving. The causality between the events and PNEUMOVAX 23 was unspecified. Additional information has been requested.
Age: 68.0
Sex: F
Vaccine: PPV
Symptoms: Peripheral swelling
Clinical narrative: Information has been received from a 68 year old female patient with lymphedema and emphysema referring to herself. The patient was allergic to "CLE+". In 2005, the patient was vaccinated with one dose of pneumococcal vaccine (unspecified) (dose and route unknown). On 03-OCT-2015, the patient was vaccinated with another dose of PNEUMOVAX 23 (dose and route unknown, in the right shoulder) at her local drug store, without consulting her physician. Concomitant medications were unspecified. On 04-OCT-2015 (reported as "the following day"), the patient began to experience chills and flu-like symptoms. When she removed her bandage, it was "full of blood", and an unspecified amount of time later, her arm began to swell below the injection site. Her arm was sore to touch. She also stated she could not lift her right arm to put on her coat. At the time of report, the patient did not seek any medical attention. No treatment was given for the events. Her chills had resolved. The outcome of other events was reported as recovering/resolving. The causality between the events and PNEUMOVAX 23 was unspecified. Additional information has been requested.
Sex: U
Vaccine: HPV9
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: Information has been received from a certified medical assistant referring to an unspecified number of patients of unknown age and gender. On 05-OCT-2015, the patients were vaccinated with improperly stored doses of GARDASIL 9 (lot # L016428, expiration date 30-JUL-2017, dose and route were not provided) (Incorrect product storage). No adverse experiences were reported. This is one of several reports received from the same reporter. Additional information has been requested.
Age: 14.0
Sex: U
Vaccine: HPV9
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: Information has been received from a registered nurse referring to an 14 year old patient of unknown gender. On 07-AUG-2015 the patient was vaccinated with GARDASIL 9 (lot # L014415, intramuscular, expiration date and dose were unknown) which excursed the storage temperature (incorrect product storage). No reaction was 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
Clinical narrative: Information has been received from a pharmacist referring to 3 newborns. Background: Since June 2015, there had been 1645 times (30 minutes each time= 822.5 hours) that the temperature dropped below 36F. Of course, there was 144 times (30 minutes each time=72 hours) that temperature was below 32F, the lowest being 29.7F. On 04-JUL-2015, there was a low temperature of 30.2F. On 13-SEP-2015 the patients were vaccinated with the improperly stored RECOMBIVAX HB strength 2.5/0.5 (units not provided) (lot number K020216 and expiration date of 17-SEP-2016) (dose and route of administration were not reported). There was no product quality complaint (PQC). This is one of several reports received from the same reporter. Additional information has been requested.
Age: 14.0
Sex: U
Vaccine: HPV9
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: Information has been received from a registered nurse referring to a 14 year old patient of unknown gender. On 06-AUG-2015 the patient was vaccinated with GARDASIL 9 (lot # L006547, intramuscular, expiration date and dose were unknown) which excursed the storage temperature (incorrect product storage). No reaction was reported. This is one of several reports received from the same reporter. Additional information has been requested.
Sex: U
Vaccine: VARZOS
Symptoms: Rash
Clinical narrative: Information has been received from a register nurse referring to a patient of unknown age and gender. Concurrent condition and medical history were not reported. On an unknown date the patient was vaccinated with ZOSTAVAX (dose, frequency, route, lot# and expiration date were unknown). On an unknown date the patient experienced a rash after receiving the ZOSTAVAX. The outcome of rash was unknown. Additional information is not expected as the physician asked not to be contacted.
Sex: U
Vaccine: RV5
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: Information has been received from a registered nurse referring to an unspecified number of patients of unknown age and gender. On 30-SEP-2015 the patients received doses of improperly stored ROTATEQ (dose, lot# and expiration date were not reported) orally. Concomitant drug was not reported. All of these vaccines had been improperly exposed to 47.5F for 2 hours and 28.9F for 11 hours on an unspecified date prior to 30-SEP-2015. 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: Information has been received from a healthcare worker (medical assistant) referring to a patient of unknown age and gender. Information about patient's concurrent conditions and medical history was not reported. On 21-SEP-2015 the patient was vaccinated with a dose of VARIVAX (Merck) (dose and route not reported, lot # L015046 with expiration date 29-APR-2017) that had been improperly stored. Concomitant medications were not provided. No adverse effects were reported. This is one of two reports received from the same reporter (other linked case # 1510USA006858). Additional information has been requested.
Sex: F
Vaccine: HPV4
Symptoms: Inappropriate schedule of drug administration, No adverse event
Clinical narrative: Information has been received from a registered nurse referring to a female patient of unknown age. The patient's medical history, concurrent condition and concomitant therapy were not provided. In June 2008 and April 2010, the patient was vaccinated with her first and second doses of GARDASIL (lot #, expiration date, dose and route not provided) by unspecified physicians, respectively (inappropriate schedule of vaccine administration). On 06-OCT-2015 (reported as today), the patient received her third dose of GARDASIL (lot # reported as L023905 with expiration date 27-MAY-2017, dose and route not provided) (inappropriate schedule of vaccine administration). No adverse experiences had been reported. Additional information has been requested.
Age: 50.0
Sex: M
Vaccine: PPV
Symptoms: Injection site erythema, Injection site pain, Pyrexia
Clinical narrative: Information has been received from a physician referring to a 50 year old male patient with diabetes mellitus. On 12-SEP-2015 the patient was vaccinated with the first dose of PNEUMOVAX 23 (lot #, expiration date, strength and dose were unknown) intramuscularly. The patient's concomitant medication was not reported. On 13-SEP-2015, the patient developed pain and redness at injection site. The patient also experienced a fever of 103F. On 18-SEP-2015, the patient visited the physician complaining that the pain and redness was getting worse. The patient was prescribed KEFLEX (500mgs), as well as ADVIL for pain. No lab diagnostics studies were performed. The outcome of the events were reported as not resolved. 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 three patients of unknown age and gender. Pertinent medical history and drug reactions/allergies were not reported. On 30-SEP-2015 the patients received doses of improperly exposed RECOMBIVAX HB (lot # L010595, expiration date 12-NOV-2016, route and dose were not reported). Concomitant drug was not reported. All of these vaccines had been improperly exposed to 47.5F for 2 hours and 28.9F for 11 hours on an unspecified date prior to 30-SEP-2015. 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: Information has been received from a nurse referring to unspecified number of patients of unknown age and gender. On unknown dates the patients were vaccinated with improperly stored VARIVAX (Merck) (lot # L020003, expiration date 02-JUN-2017) (dose and route were not reported). No adverse effects were 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
Clinical narrative: Information has been received from a pharmacist referring to 5 newborns. Background: Since June 2015, there had been 1645 times (30 minutes each time= 822.5 hours) that the temperature dropped below 36F. Of course, there was 144 times (30 minutes each time=72 hours) that temperature was below 32F, the lowest being 29.7F. On 04-JUL-2015, there was a low temperature of 30.2F. On 20-SEP-2015 the patients were vaccinated with the improperly stored RECOMBIVAX HB strength 2.5/0.5 (units not provided) (lot number K020216 and expiration date of 17-SEP-2016) (dose and route of administration were not reported). There was no product quality complaint (PQC). This is one of several reports received from the same reporter. Additional information has been requested.
Sex: F
Vaccine: VARZOS
Symptoms: Condition aggravated, Herpes zoster
Clinical narrative: This spontaneous report was received via company representative from a nurse, female patient of unknown age, refers to herself. The patient's medical history included two prior cases of shingles on unspecified dates. There was no patient's concurrent conditions, concomitant medications and drug reactions or allergies reported. On an unknown date, the patient was vaccinated with ZOSTAVAX injection (lot#, expiration date, dose, anatomical location and route of administration were not reported). On an unknown date, 3 years after receiving ZOSAVAX, the patient experienced shingles. No treatment was given and no lab diagnostics studies were performed. The outcome of the event was unknown. The patient did not seek medical attention. The relatedness between the event and ZOSTAVAX was not 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 licensed visiting nurse, referring to seven unspecified patients of unknown ages and genders. There was no medical history and concurrent conditions reported for the patients. On 05-OCT-2015, the seven unspecified patients were vaccinated with improperly stored doses of VARIVAX (Merck) lot # L010145, expiration date 24-MAR-2017 (dose, frequency and route were not reported). No concomitant medications and no adverse effects were reported. No product quality complaint was involved. Additional information has been requested.
Age: 0.5
Sex: F
Vaccine: DTAPIPVHIB, FLU3, HEP, PNC13, RV5
Symptoms: Dyskinesia, Staring, Tremor
Clinical narrative: Great grandmother reports that when they got home from appt and went to take patient out of carrier she had an episode of staring and shaking that lasted a couple of seconds and repeated the activity again 1 minute after. Went to ER and was evaluated. Referred to neurology for follow up. Dx: abnormal involuntary movements
Age: 83.0
Sex: F
Vaccine: PNC13
Symptoms: Erythema, Swelling
Clinical narrative: Developed fist sized area of swelling and redness. Treated with IM BENADRYL and PO BENADRYL for home and cool packs.
Age: 11.0
Sex: M
Vaccine: HPV4, MNQ, TDAP
Symptoms: Injection site erythema, Injection site swelling
Clinical narrative: (R) arm has mild swelling and redness to injection sites. However, moderate redness to BCG site (no shot in here).
Age: 0.43
Sex: F
Vaccine: DTAP
Symptoms: Crying, Pyrexia
Clinical narrative: This case was reported by a other health professional via call center representative and described the occurrence of fever in a 5-month-old female patient who received DTPA vaccine. On 31st October 2003, the patient received the 2nd dose of DTPa vaccine. On an unknown date, an unknown time after receiving DTPa vaccine, the patient experienced fever and crying. On an unknown date, the outcome of the fever and crying were recovered/resolved. It was unknown if the reporter considered the fever and crying to be related to DTPa vaccine. Additional details provided were as follows: The patient received an unspecified brand of DTPa vaccine. The patient experienced high fever and cried for days. No further information regarding the reported events was available.
Sex: U
Vaccine: VARZOS
Symptoms: Extra dose administered, No adverse event
Clinical narrative: This spontaneous report was received from a nurse and refers to a patient of unknown age and gender. No information regarding the patient's pertinent medical history, concomitant medication and drug reactions or allergies was reported. On 09-OCT-2015 (reported as today), the patient was vaccinated with a second (extra) dose of ZOSTAVAX, vial (strength, dose, route of administration, lot # and expiration date were not provided). The patient received a first dose of ZOSTAVAX (strength, dose, route of administration, lot # and expiration date were not provided) on an unknown date in October 2014 (reported as "1 year ago"). No adverse effects were reported. Additional information has been requested.
Sex: M
Vaccine: MMR
Symptoms: Measles antibody negative
Clinical narrative: This spontaneous report was received from a physician and refers to a male patient of unknown age. The patient's medical history, concurrent conditions and concomitant therapies were not reported. On unknown dates, the patient was vaccinated with first and second dose of M-M-R II (lot #, dose, route of administration and anatomical location were not provided). On an unknown date, the patient had titers drawn which showed he was negative for measles. The outcome of the event was unknown. The relatedness between the event and M-M-R II was not reported. Additional information is not expected, as no contact details were provided.
Sex: U
Vaccine: HEPA
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report as received from a certified medical assistant refers to an unspecified number of patients of unknown age and gender. No information on patients' medical history or concurrent conditions was provided. On an unknown dates, the patients were vaccinated with improperly stored doses of VAQTA injection, lot# K008333 with expiration date 10-MAR-2017, L007559 with expiration date 01-JUN-2017, and L004743 with expiration date 01-JAN-2017 (dose and route of administration were not reported). No information on patients' concomitant medications was provided. No adverse symptoms 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: This spontaneous report as received from a certified medical assistant refers to an unspecified number of patients of unknown age and gender. No information on patients' medical history or concurrent conditions was provided. On an unknown dates, the patients were vaccinated with improperly stored doses of RECOMBIVAX HB injection, lot# J014855 with expiration date 16-APR-2016, and lot# K026666 with expiration date 22-OCT-2016 (dose and route of administration were not reported). No information on patients' concomitant medications was provided. No adverse symptoms were reported. This is one of the several reports from the same reporter. Additional information has been requested.
Age: 12.0
Sex: U
Vaccine: HPV9
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: Information has been received from a registered nurse referring to a 12 year old patient of unknown gender. On 06-AUG-2015 the patient was vaccinated with GARDASIL 9 (lot # L006547, intramuscular, expiration date and dose were unknown) which excursed the storage temperature (incorrect product storage). No reaction was reported. This is one of several reports received from the same reporter. Additional information has been requested.
Age: 11.0
Sex: U
Vaccine: HPV9
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: Information has been received from a registered nurse referring to an 11 year old patient of unknown gender. On 06-AUG-2015 the patient was vaccinated with GARDASIL 9 (lot # L006547, intramuscular, expiration date and dose were unknown) which excursed the storage temperature (incorrect product storage). No reaction 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: Information has been received from a healthcare worker (medical assistant) referring to a patient of unknown age and gender. Information about patient's concurrent conditions and medical history was not reported. On 09-OCT-2015 the patient was vaccinated with a dose of VARIVAX (Merck) (dose and route not reported, lot # L015046 with expiration date 29-APR-2017) that had been improperly stored. Concomitant medications were not provided. No adverse effects were reported. This is one of two reports received from the same reporter (other linked case # 1510USA006825). Additional information has been requested.
Sex: U
Vaccine: HEPA
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: Information has been received from a registered nurse referring to a patient of unknown age and gender. Pertinent medical history and drug reactions/allergies were not reported. On 30-SEP-2015 the patient received a dose of improperly exposed VAQTA (lot # L023232, expiration date 25-FEB-2017, dose and route were not reported). Concomitant drug was not reported. The vaccine had been improperly exposed to 47.5F for 2 hours and 28.9F for 11 hours on an unspecified date prior to 30-SEP-2015. 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
Clinical narrative: Information has been received from a pharmacist referring to 3 newborns. Background: Since June 2015, there had been 1645 times (30 minutes each time=822.5 hours) that the temperature dropped below 36F. Of course, there was 144 times (30 minutes each time=72 hours) that temperature was below 32F, the lowest being 29.7F. On 04-JUL-2015, there was a low temperature of 30.2F. On 19-SEP-2015 the patients were vaccinated with the improperly stored RECOMBIVAX HB strength 2.5/0.5 (units not provided) (lot number K020216 and expiration date of 17-SEP-2016) (dose and route of administration were not reported). There was no product quality complaint (PQC). This is one of several reports received from the same reporter. Additional information has been requested.
Sex: U
Vaccine: HEP
Symptoms: Incorrect product storage
Clinical narrative: Information has been received from a pharmacist referring to 5 newborns. Background: Since June 2015, there had been 1645 times (30 minutes each time=822.5 hours) that the temperature dropped below 36F. Of course, there was 144 times (30 minutes each time=72 hours) that temperature was below 32F, the lowest being 29.7F. On 04-JUL-2015, there was a low temperature of 30.2F. On 17-SEP-2015 the patients were vaccinated with the improperly stored RECOMBIVAX HB strength 2.5/0.5 (units not provided) (lot number K020216 and expiration date of 17-SEP-2016) (dose and route of administration were not reported). There was no product quality complaint (PQC). 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 certified medical assistant referring to an unspecified number of patients of unknown age and gender. On 05-OCT-2015, the patients were vaccinated with improperly stored doses of ROTATEQ (lot # K011952, expiration date 17-JUN-2016, route: oral, dose not provided). No adverse experiences were reported. This is one of several reports received from the same reporter. Additional information has been requested.
Age: 56.0
Sex: M
Vaccine: FLU3
Symptoms: Pain in extremity, Paraesthesia
Clinical narrative: Patient's wife reported 2 days after vaccination, patient experienced tingling from shoulder to fingers that was extremely painful. The pain was not relieved w/OTC medications or muscle rubs. Other family members who received the same day were not affected.
Age: 0.7
Sex: M
Vaccine: DTAP, HIBV, PNC13, RV5, DTAP
Symptoms: Blood calcium, Blood electrolytes, Blood potassium, Computerised tomogram head, Dyskinesia
Clinical narrative: Initial unsolicited report received from a consumer (patient's parent) on 02-Oct-2015. This case involves an eight months old male patient who was vaccinated with a dose of DAPTACEL via intramuscular route (batch number, expiry date and site of administration were not provided) on an unspecified date (reported as two months ago). The patient did not have any illness at the time of vaccination and pre-existing physician diagnosed allergies, birth defects and medical conditions (specify) is unknown. Concomitant medications were not reported. On an unspecified date (reported as two months ago); 1.5 hours post vaccination, the patient was jerking his head from side to side, his eyes rolled back, right arm went stiff, one leg was moving slower. He still moved his head from side to side and "he seemed like he was in another world". These episodes last up to 20 minutes. It was reported that he had done a lot of laboratory tests (unspecified). Corrective treatment was not provided. He was under care of neurologists. He required ER/doctor visit. It was reported that the patient was "ok". He had recovered from the above mentioned events on an unspecified date. Upon internal review this case was considered serious due to important medical event: jerking head from side to side. List of documents held by sender: none.
Age: 0.7
Sex: M
Vaccine: DTAP, HIBV, PNC13, RV5, DTAP
Symptoms: Electroencephalogram
Clinical narrative: Initial unsolicited report received from a consumer (patient's parent) on 02-Oct-2015. This case involves an eight months old male patient who was vaccinated with a dose of DAPTACEL via intramuscular route (batch number, expiry date and site of administration were not provided) on an unspecified date (reported as two months ago). The patient did not have any illness at the time of vaccination and pre-existing physician diagnosed allergies, birth defects and medical conditions (specify) is unknown. Concomitant medications were not reported. On an unspecified date (reported as two months ago); 1.5 hours post vaccination, the patient was jerking his head from side to side, his eyes rolled back, right arm went stiff, one leg was moving slower. He still moved his head from side to side and "he seemed like he was in another world". These episodes last up to 20 minutes. It was reported that he had done a lot of laboratory tests (unspecified). Corrective treatment was not provided. He was under care of neurologists. He required ER/doctor visit. It was reported that the patient was "ok". He had recovered from the above mentioned events on an unspecified date. Upon internal review this case was considered serious due to important medical event: jerking head from side to side. List of documents held by sender: none.
Age: 0.7
Sex: M
Vaccine: DTAP, HIBV, PNC13, RV5, DTAP
Symptoms: Abnormal behaviour, Dyskinesia, Eye movement disorder, Hypokinesia, Laboratory test
Clinical narrative: Initial unsolicited report received from a consumer (patient's parent) on 02-Oct-2015. This case involves an eight months old male patient who was vaccinated with a dose of DAPTACEL via intramuscular route (batch number, expiry date and site of administration were not provided) on an unspecified date (reported as two months ago). The patient did not have any illness at the time of vaccination and pre-existing physician diagnosed allergies, birth defects and medical conditions (specify) is unknown. Concomitant medications were not reported. On an unspecified date (reported as two months ago); 1.5 hours post vaccination, the patient was jerking his head from side to side, his eyes rolled back, right arm went stiff, one leg was moving slower. He still moved his head from side to side and "he seemed like he was in another world". These episodes last up to 20 minutes. It was reported that he had done a lot of laboratory tests (unspecified). Corrective treatment was not provided. He was under care of neurologists. He required ER/doctor visit. It was reported that the patient was "ok". He had recovered from the above mentioned events on an unspecified date. Upon internal review this case was considered serious due to important medical event: jerking head from side to side. List of documents held by sender: none.
Age: 0.7
Sex: M
Vaccine: DTAP, HIBV, PNC13, RV5, DTAP
Symptoms: Musculoskeletal stiffness
Clinical narrative: Initial unsolicited report received from a consumer (patient's parent) on 02-Oct-2015. This case involves an eight months old male patient who was vaccinated with a dose of DAPTACEL via intramuscular route (batch number, expiry date and site of administration were not provided) on an unspecified date (reported as two months ago). The patient did not have any illness at the time of vaccination and pre-existing physician diagnosed allergies, birth defects and medical conditions (specify) is unknown. Concomitant medications were not reported. On an unspecified date (reported as two months ago); 1.5 hours post vaccination, the patient was jerking his head from side to side, his eyes rolled back, right arm went stiff, one leg was moving slower. He still moved his head from side to side and "he seemed like he was in another world". These episodes last up to 20 minutes. It was reported that he had done a lot of laboratory tests (unspecified). Corrective treatment was not provided. He was under care of neurologists. He required ER/doctor visit. It was reported that the patient was "ok". He had recovered from the above mentioned events on an unspecified date. Upon internal review this case was considered serious due to important medical event: jerking head from side to side. List of documents held by sender: none.
Age: 67.0
Sex: F
Vaccine: FLU3, FLU3
Symptoms: Injection site joint movement impairment, Injection site joint pain
Clinical narrative: Pain at injection site.
Age: 67.0
Sex: F
Vaccine: FLU3, FLU3
Symptoms: Injection site pain, Nuclear magnetic resonance imaging, X-ray
Clinical narrative: Pain at injection site.
Age: 69.0
Sex: F
Vaccine: PPV, PPV
Symptoms: Biopsy, Burning sensation, Erythema, Peripheral swelling, Skin atrophy
Clinical narrative: This spontaneous report was received from a dermatologist and from a 69 year old female consumer who was reporting on herself. The patient's pertinent medical history and concomitant medications were not reported. The patient was allergic to "sulfa" and LEVAQUIN was "too strong" for her. On 24-AUG-2015, the patient was vaccinated with a dose of PNEUMOVAX 23 (dose, route of administration, lot # and expiration date were not provided). The patient stated that for two days after vaccination (from an unknown date, in approximately 2015) "everything hurt" and she reported flu-like symptoms during the same time frame. On 25-AUG-2015, about 24 hours after the PNEUMOVAX 23 injection, her arm from the elbow almost to the shoulder swelled, turned red and was hot to touch. Then on an unknown date in 2015, the area turned black and blue, then all black and looked like a scab. The patient also reported that the injection area resembled a "crater". In addition (from an unspecified date, in approximately 2015), the patient felt "constant little pricks" in the affected arm. The patient stated that at the reporting time, the area was still itching, but the black mark was down to approximately one inch. The patient sought medical attention - she had been seeing with a dermatologist in her office three times since 25-AUG-2015. The dermatologist stated that the mid upper lateral left arm had a purplish nodule which was warm and hard and which became an open ulcer on an unknown date, in approximately 2015. The ulcer was not infected and she was treating the patient with a dry sterile dressing. The patient was also prescribed with an unspecified steroid cream. Blood work was done on an unspecified date but the results were not provided. The outcome of the events was reported as recovering. The relatedness between the events and PNEUMOVAX 23 was not reported. Additional information has been requested.
Age: 69.0
Sex: F
Vaccine: PPV, PPV
Symptoms: Skin discolouration, Skin ulcer
Clinical narrative: This spontaneous report was received from a dermatologist and from a 69 year old female consumer who was reporting on herself. The patient's pertinent medical history and concomitant medications were not reported. The patient was allergic to "sulfa" and LEVAQUIN was "too strong" for her. On 24-AUG-2015, the patient was vaccinated with a dose of PNEUMOVAX 23 (dose, route of administration, lot # and expiration date were not provided). The patient stated that for two days after vaccination (from an unknown date, in approximately 2015) "everything hurt" and she reported flu-like symptoms during the same time frame. On 25-AUG-2015, about 24 hours after the PNEUMOVAX 23 injection, her arm from the elbow almost to the shoulder swelled, turned red and was hot to touch. Then on an unknown date in 2015, the area turned black and blue, then all black and looked like a scab. The patient also reported that the injection area resembled a "crater". In addition (from an unspecified date, in approximately 2015), the patient felt "constant little pricks" in the affected arm. The patient stated that at the reporting time, the area was still itching, but the black mark was down to approximately one inch. The patient sought medical attention - she had been seeing with a dermatologist in her office three times since 25-AUG-2015. The dermatologist stated that the mid upper lateral left arm had a purplish nodule which was warm and hard and which became an open ulcer on an unknown date, in approximately 2015. The ulcer was not infected and she was treating the patient with a dry sterile dressing. The patient was also prescribed with an unspecified steroid cream. Blood work was done on an unspecified date but the results were not provided. The outcome of the events was reported as recovering. The relatedness between the events and PNEUMOVAX 23 was not reported. Additional information has been requested.
Age: 69.0
Sex: F
Vaccine: PPV, PPV
Symptoms: Blood test, Induration, Influenza like illness, Injection site discolouration, Injection site erythema
Clinical narrative: This spontaneous report was received from a dermatologist and from a 69 year old female consumer who was reporting on herself. The patient's pertinent medical history and concomitant medications were not reported. The patient was allergic to "sulfa" and LEVAQUIN was "too strong" for her. On 24-AUG-2015, the patient was vaccinated with a dose of PNEUMOVAX 23 (dose, route of administration, lot # and expiration date were not provided). The patient stated that for two days after vaccination (from an unknown date, in approximately 2015) "everything hurt" and she reported flu-like symptoms during the same time frame. On 25-AUG-2015, about 24 hours after the PNEUMOVAX 23 injection, her arm from the elbow almost to the shoulder swelled, turned red and was hot to touch. Then on an unknown date in 2015, the area turned black and blue, then all black and looked like a scab. The patient also reported that the injection area resembled a "crater". In addition (from an unspecified date, in approximately 2015), the patient felt "constant little pricks" in the affected arm. The patient stated that at the reporting time, the area was still itching, but the black mark was down to approximately one inch. The patient sought medical attention - she had been seeing with a dermatologist in her office three times since 25-AUG-2015. The dermatologist stated that the mid upper lateral left arm had a purplish nodule which was warm and hard and which became an open ulcer on an unknown date, in approximately 2015. The ulcer was not infected and she was treating the patient with a dry sterile dressing. The patient was also prescribed with an unspecified steroid cream. Blood work was done on an unspecified date but the results were not provided. The outcome of the events was reported as recovering. The relatedness between the events and PNEUMOVAX 23 was not reported. Additional information has been requested.
Age: 69.0
Sex: F
Vaccine: PPV, PPV
Symptoms: Injection site pruritus, Injection site scab, Injection site swelling, Injection site warmth, Nodule
Clinical narrative: This spontaneous report was received from a dermatologist and from a 69 year old female consumer who was reporting on herself. The patient's pertinent medical history and concomitant medications were not reported. The patient was allergic to "sulfa" and LEVAQUIN was "too strong" for her. On 24-AUG-2015, the patient was vaccinated with a dose of PNEUMOVAX 23 (dose, route of administration, lot # and expiration date were not provided). The patient stated that for two days after vaccination (from an unknown date, in approximately 2015) "everything hurt" and she reported flu-like symptoms during the same time frame. On 25-AUG-2015, about 24 hours after the PNEUMOVAX 23 injection, her arm from the elbow almost to the shoulder swelled, turned red and was hot to touch. Then on an unknown date in 2015, the area turned black and blue, then all black and looked like a scab. The patient also reported that the injection area resembled a "crater". In addition (from an unspecified date, in approximately 2015), the patient felt "constant little pricks" in the affected arm. The patient stated that at the reporting time, the area was still itching, but the black mark was down to approximately one inch. The patient sought medical attention - she had been seeing with a dermatologist in her office three times since 25-AUG-2015. The dermatologist stated that the mid upper lateral left arm had a purplish nodule which was warm and hard and which became an open ulcer on an unknown date, in approximately 2015. The ulcer was not infected and she was treating the patient with a dry sterile dressing. The patient was also prescribed with an unspecified steroid cream. Blood work was done on an unspecified date but the results were not provided. The outcome of the events was reported as recovering. The relatedness between the events and PNEUMOVAX 23 was not reported. Additional information has been requested.
Age: 69.0
Sex: F
Vaccine: PPV, PPV
Symptoms: Pain, Paraesthesia, Skin warm, Ulcer
Clinical narrative: This spontaneous report was received from a dermatologist and from a 69 year old female consumer who was reporting on herself. The patient's pertinent medical history and concomitant medications were not reported. The patient was allergic to "sulfa" and LEVAQUIN was "too strong" for her. On 24-AUG-2015, the patient was vaccinated with a dose of PNEUMOVAX 23 (dose, route of administration, lot # and expiration date were not provided). The patient stated that for two days after vaccination (from an unknown date, in approximately 2015) "everything hurt" and she reported flu-like symptoms during the same time frame. On 25-AUG-2015, about 24 hours after the PNEUMOVAX 23 injection, her arm from the elbow almost to the shoulder swelled, turned red and was hot to touch. Then on an unknown date in 2015, the area turned black and blue, then all black and looked like a scab. The patient also reported that the injection area resembled a "crater". In addition (from an unspecified date, in approximately 2015), the patient felt "constant little pricks" in the affected arm. The patient stated that at the reporting time, the area was still itching, but the black mark was down to approximately one inch. The patient sought medical attention - she had been seeing with a dermatologist in her office three times since 25-AUG-2015. The dermatologist stated that the mid upper lateral left arm had a purplish nodule which was warm and hard and which became an open ulcer on an unknown date, in approximately 2015. The ulcer was not infected and she was treating the patient with a dry sterile dressing. The patient was also prescribed with an unspecified steroid cream. Blood work was done on an unspecified date but the results were not provided. The outcome of the events was reported as recovering. The relatedness between the events and PNEUMOVAX 23 was not reported. Additional information has been requested.
Age: 1.0
Sex: M
Vaccine: FLU3, MMRV, PNC13, VARCEL, MMRV, VARCEL
Symptoms: No adverse event, Wrong drug administered
Clinical narrative: This spontaneous report was received from a physician refers to a 12 month old male patient. The patient's concurrent conditions, medical history and concomitant medications were not provided. On 12-OCT-2015, the patient was vaccinated with an unspecified dose of VARIVAX lot # L013063 and expiration date 14-APR-2017 and he was also vaccinated with an unspecified dose of PROQUAD lot# L030588 and expiration date 10-FEB-2017 as reported (route of administration and anatomical location were not provided for both vaccines). The reporter stated that the patient should had been vaccinated with MMR II and VARIVAX, the reporter referred that it was staff error only. No adverse events were reported. There was no product quality issue involved. This is one of two cases from the same reporter. Additional information has been requested.
Age: 41.0
Sex: F
Vaccine: FLU3
Symptoms: Body temperature increased
Clinical narrative: Temperature of 102.6 degrees F.
Age: 48.0
Sex: M
Vaccine: FLUX
Symptoms: Axillary mass, Tenderness, Ultrasound scan
Clinical narrative: I found a large lump under left armpit. Very tender. Same arm as injection.
Age: 65.0
Sex: F
Vaccine: FLU3
Symptoms: Hypoaesthesia, Pain in extremity, Paraesthesia, Pruritus
Clinical narrative: Tingling, itching numbness ache down area of arm all the way to thumb.
Age: 68.0
Sex: F
Vaccine: FLU3
Symptoms: Injection site erythema, Pain in extremity
Clinical narrative: Sore, aching, left arm and large red area below injection site for seven days.
Age: 33.0
Sex: F
Vaccine: FLU3
Symptoms: Arthralgia, Cough, Diarrhoea, Dizziness, Headache
Clinical narrative: Started with headache, sore throat, coughing, congestion, diarrhea, fever 102, dizziness, sore muscles and joints.
Age: 33.0
Sex: F
Vaccine: FLU3
Symptoms: Myalgia, Oropharyngeal pain, Pyrexia, Respiratory tract congestion
Clinical narrative: Started with headache, sore throat, coughing, congestion, diarrhea, fever 102, dizziness, sore muscles and joints.
Age: 56.0
Sex: M
Vaccine: FLU3
Symptoms: Neck pain, Pain in extremity
Clinical narrative: RADIATING ACHE AND PAIN FROM ELBOW TO SHOULDER.  AFTER 2 WEEKS PAIN CONTINUES AND IS NOW CAUSING SOME NECK PAIN.  PRESCRIBED PREDNISONE 20 MG BY DOCTOR FOR 8 DAYS.  MID TREATMENT (DAY 3) AS OF THIS WRITING WITH 80% RELIEF.
Age: 66.0
Sex: F
Vaccine: FLU3
Symptoms: Chest pain, Chills, Cough, Oropharyngeal pain, Pain
Clinical narrative: Hives on arm  that received injection, chills, cough, chest pain when coughing, sore throat general aches all over.
Age: 66.0
Sex: F
Vaccine: FLU3
Symptoms: Urticaria
Clinical narrative: Hives on arm  that received injection, chills, cough, chest pain when coughing, sore throat general aches all over.
Sex: F
Vaccine: FLUC3
Symptoms: Influenza
Clinical narrative: Case number PHEH2015US019967, is an initial spontaneous report from a consumer received on 05 Oct 2015. This report refers to female patient of unknown age. Historical conditions were not reported. No concomitant medication was reported. The patient received FLUCELVAX (batch number: not reported) intramuscularly on 16 Sep 2015. On 01 Oct 2015, the patient experienced flu. The patient started to recover from the event on 05 Oct 2015. Seriousness of the events was not reported. Seriousness of the events was upgraded based on information available in the source document. Causality was not reported. No consent to contact and reporter's details were not provided.
Age: 68.0
Sex: F
Vaccine: FLU3
Symptoms: Dizziness, Encephalitis, Mobility decreased, Pyrexia, Speech disorder
Clinical narrative: Fever or 101; trouble talking; not able to move right side of body; dizzy.