chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 63.0
Sex: F
Vaccine: RAB
Symptoms: Balance disorder, Headache, Lumbar puncture abnormal, Meningitis aseptic, Mental status changes
Clinical narrative: Patient received first 2 doses of RabAvert at outside facility. Developed itchy rash with "hives" in arms where she received vaccine, along with imbalance and altered mental status. Found to have aseptic meningitis on LP. She received her third dose in the series at our facility (Imovax). She developed itching, headache, and imbalance after this third dose. Felt better with fluids and Benadryl. Pt desires to continue rabies vaccine schedule.
Age: 63.0
Sex: F
Vaccine: RAB
Symptoms: Pruritus, Rash pruritic, Urticaria
Clinical narrative: Patient received first 2 doses of RabAvert at outside facility. Developed itchy rash with "hives" in arms where she received vaccine, along with imbalance and altered mental status. Found to have aseptic meningitis on LP. She received her third dose in the series at our facility (Imovax). She developed itching, headache, and imbalance after this third dose. Felt better with fluids and Benadryl. Pt desires to continue rabies vaccine schedule.
Age: 1.03
Sex: M
Vaccine: HEPA, MEN, MMR, UNK
Symptoms: Cow's milk intolerance, Decreased appetite, Diarrhoea, Fall, Gait disturbance
Clinical narrative: GI issues Severe Diarrhea for weeks, intolerance to dairy, decreased appetite, consistent fever 103, leg weakness would fall and stumble, scream in pain for hours, would not sleep for longer then 30min-1 hour at a time, irregular sleeping, constantly yells and screams, cries as if he is in pain, behavioral regression no longer able to talk does not even say mama or dada symptoms have been going on for at least 1-2 months now. He completely is not the same kid any more. His blood work that was done all came back abnormal.
Age: 1.03
Sex: M
Vaccine: HEPA, MEN, MMR, UNK
Symptoms: Irregular sleep phase, Laboratory test abnormal, Muscular weakness, Pain, Pyrexia
Clinical narrative: GI issues Severe Diarrhea for weeks, intolerance to dairy, decreased appetite, consistent fever 103, leg weakness would fall and stumble, scream in pain for hours, would not sleep for longer then 30min-1 hour at a time, irregular sleeping, constantly yells and screams, cries as if he is in pain, behavioral regression no longer able to talk does not even say mama or dada symptoms have been going on for at least 1-2 months now. He completely is not the same kid any more. His blood work that was done all came back abnormal.
Age: 1.03
Sex: M
Vaccine: HEPA, MEN, MMR, UNK
Symptoms: Regressive behaviour, Screaming, Sleep disorder, Speech disorder developmental
Clinical narrative: GI issues Severe Diarrhea for weeks, intolerance to dairy, decreased appetite, consistent fever 103, leg weakness would fall and stumble, scream in pain for hours, would not sleep for longer then 30min-1 hour at a time, irregular sleeping, constantly yells and screams, cries as if he is in pain, behavioral regression no longer able to talk does not even say mama or dada symptoms have been going on for at least 1-2 months now. He completely is not the same kid any more. His blood work that was done all came back abnormal.
Age: 60.0
Sex: M
Vaccine: VARZOS
Symptoms: Injection site pruritus, Injection site swelling
Clinical narrative: Pt called the pharmacy and said the injection site swelled up and was itchy.  Per AE protocol, pt was advised to take Benadryl and ice injection site.  The next day, pt said itching has subsided but there is still some swelling.
Age: 58.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site erythema, Injection site pruritus, Injection site swelling, Injection site urticaria, Injection site warmth
Clinical narrative: The patient reported a red, itch, swollen, warm welt measuring 4 inches across at the injection site. Patient took oral diphenhydramine and applied aloe vera gel to the site.
Age: 11.0
Sex: F
Vaccine: HPVX
Symptoms: Computerised tomogram, Electroencephalogram, Generalised tonic-clonic seizure, Laboratory test, Nuclear magnetic resonance imaging
Clinical narrative: Patient had a tonic-clonic seizure lasting between 3-5 minutes with three hour postictal state. Patient was transported to ER by ambulance. Patient again had a tonic-clonic seizure August 6, 2016 again requiring transport by ambulance to ER.
Age: 11.0
Sex: F
Vaccine: HPVX
Symptoms: Postictal state, Urine analysis
Clinical narrative: Patient had a tonic-clonic seizure lasting between 3-5 minutes with three hour postictal state. Patient was transported to ER by ambulance. Patient again had a tonic-clonic seizure August 6, 2016 again requiring transport by ambulance to ER.
Age: 38.0
Sex: F
Vaccine: FLUX
Symptoms: Activities of daily living impaired, Biopsy muscle, Biopsy peripheral nerve, Chronic inflammatory demyelinating polyradiculoneuropathy, Dizziness
Clinical narrative: DEC 2013 START- HEADACHES, DIZZINESS, PERIPHERAL VISION AFFECTED, GRADUAL WORSENING OVER FUTURE MONTHS WITH NUMBNESS IN FINGERS, WEAKENING ARM AND LEG STRENGTH, PROXIMAL MUSCLES AFFECTED, E.G. CAN'T CLIMB STAIRS OR OPEN MILK GALLON OR CARRY BABY DAUGHTER. GRADUALLY WORSENS TO WEAR CAN'T SIT ON TOILET SEAT MYSELF OR GET UP FROM COUCH. TAKEN TO E.R. IN 2014 AND ADMITTED AFTER TESTS. PROVIDED PLASMAPHERESIS TREATMENTS WHICH HELP A LITTLE AND WAS RELEASED. RELAPSE WITHIN A FEW WEEKS WITH SYMPTOMS RAPIDLY RETURNING. VISIT E.R IN SUMMER 2014 AND READMITTED. MORE PLASMAPHERESIS TREATMENTS GIVEN, NERVE AND MUSCLE BIOPSY TAKEN WITH NO NEW DIAGNOSIS. RELEASED ONLY TO RELAPSE AGAIN WITHIN A FEW WEEKS, WITH SYMPTOMS WORSENING EACH TIME. CAN BARELY WALK, NEED SPOUSE TO LIFT AND CARRY ME TO TOILET, COUCH ETC. CAN'T FEED MYSELF OR CARRY/HOLD MY LITTLE BABY DAUGHTER THIS WHOLE TIME. GO THIS TIME TO E.R. AND ADMITTED AGAIN INTO HOSPITAL. DIAGNOSIS MADE OF CIDP AND GIVEN METHYL PREDNISONE. KEPT FOR 5 DAYS AND RELEASED. RELAPSE OVER WEEKEND AND READMITTED INTO SAME E.R AND TO SPECIALTY FACILITY ON MONDAY AM. THIS TIME GIVEN HIGH DOSAGE IVIG TREATMENT AND SLIGHT RECOVERY. RELEASED AND GIVEN HIGH DOSAGE IVIG TREATMENT ALONG WITH ORAL PREDNISONE TREATMENT. I HAVE EVER SINCE TO THIS DAY RECEIVED IVIG TREATEMENT EVERY 4 WEEKS IN A HIGH DOSAGE, AS OTHERWISE I WILL RELAPSE WITH CIDP SYMPTOMS RECURRING.
Age: 38.0
Sex: F
Vaccine: FLUX
Symptoms: Gait disturbance, Headache, Hypoaesthesia, Immunoglobulin therapy, Mobility decreased
Clinical narrative: DEC 2013 START- HEADACHES, DIZZINESS, PERIPHERAL VISION AFFECTED, GRADUAL WORSENING OVER FUTURE MONTHS WITH NUMBNESS IN FINGERS, WEAKENING ARM AND LEG STRENGTH, PROXIMAL MUSCLES AFFECTED, E.G. CAN'T CLIMB STAIRS OR OPEN MILK GALLON OR CARRY BABY DAUGHTER. GRADUALLY WORSENS TO WEAR CAN'T SIT ON TOILET SEAT MYSELF OR GET UP FROM COUCH. TAKEN TO E.R. IN 2014 AND ADMITTED AFTER TESTS. PROVIDED PLASMAPHERESIS TREATMENTS WHICH HELP A LITTLE AND WAS RELEASED. RELAPSE WITHIN A FEW WEEKS WITH SYMPTOMS RAPIDLY RETURNING. VISIT E.R IN SUMMER 2014 AND READMITTED. MORE PLASMAPHERESIS TREATMENTS GIVEN, NERVE AND MUSCLE BIOPSY TAKEN WITH NO NEW DIAGNOSIS. RELEASED ONLY TO RELAPSE AGAIN WITHIN A FEW WEEKS, WITH SYMPTOMS WORSENING EACH TIME. CAN BARELY WALK, NEED SPOUSE TO LIFT AND CARRY ME TO TOILET, COUCH ETC. CAN'T FEED MYSELF OR CARRY/HOLD MY LITTLE BABY DAUGHTER THIS WHOLE TIME. GO THIS TIME TO E.R. AND ADMITTED AGAIN INTO HOSPITAL. DIAGNOSIS MADE OF CIDP AND GIVEN METHYL PREDNISONE. KEPT FOR 5 DAYS AND RELEASED. RELAPSE OVER WEEKEND AND READMITTED INTO SAME E.R AND TO SPECIALTY FACILITY ON MONDAY AM. THIS TIME GIVEN HIGH DOSAGE IVIG TREATMENT AND SLIGHT RECOVERY. RELEASED AND GIVEN HIGH DOSAGE IVIG TREATMENT ALONG WITH ORAL PREDNISONE TREATMENT. I HAVE EVER SINCE TO THIS DAY RECEIVED IVIG TREATEMENT EVERY 4 WEEKS IN A HIGH DOSAGE, AS OTHERWISE I WILL RELAPSE WITH CIDP SYMPTOMS RECURRING.
Age: 38.0
Sex: F
Vaccine: FLUX
Symptoms: Muscular weakness, Plasmapheresis, Visual field defect
Clinical narrative: DEC 2013 START- HEADACHES, DIZZINESS, PERIPHERAL VISION AFFECTED, GRADUAL WORSENING OVER FUTURE MONTHS WITH NUMBNESS IN FINGERS, WEAKENING ARM AND LEG STRENGTH, PROXIMAL MUSCLES AFFECTED, E.G. CAN'T CLIMB STAIRS OR OPEN MILK GALLON OR CARRY BABY DAUGHTER. GRADUALLY WORSENS TO WEAR CAN'T SIT ON TOILET SEAT MYSELF OR GET UP FROM COUCH. TAKEN TO E.R. IN 2014 AND ADMITTED AFTER TESTS. PROVIDED PLASMAPHERESIS TREATMENTS WHICH HELP A LITTLE AND WAS RELEASED. RELAPSE WITHIN A FEW WEEKS WITH SYMPTOMS RAPIDLY RETURNING. VISIT E.R IN SUMMER 2014 AND READMITTED. MORE PLASMAPHERESIS TREATMENTS GIVEN, NERVE AND MUSCLE BIOPSY TAKEN WITH NO NEW DIAGNOSIS. RELEASED ONLY TO RELAPSE AGAIN WITHIN A FEW WEEKS, WITH SYMPTOMS WORSENING EACH TIME. CAN BARELY WALK, NEED SPOUSE TO LIFT AND CARRY ME TO TOILET, COUCH ETC. CAN'T FEED MYSELF OR CARRY/HOLD MY LITTLE BABY DAUGHTER THIS WHOLE TIME. GO THIS TIME TO E.R. AND ADMITTED AGAIN INTO HOSPITAL. DIAGNOSIS MADE OF CIDP AND GIVEN METHYL PREDNISONE. KEPT FOR 5 DAYS AND RELEASED. RELAPSE OVER WEEKEND AND READMITTED INTO SAME E.R AND TO SPECIALTY FACILITY ON MONDAY AM. THIS TIME GIVEN HIGH DOSAGE IVIG TREATMENT AND SLIGHT RECOVERY. RELEASED AND GIVEN HIGH DOSAGE IVIG TREATMENT ALONG WITH ORAL PREDNISONE TREATMENT. I HAVE EVER SINCE TO THIS DAY RECEIVED IVIG TREATEMENT EVERY 4 WEEKS IN A HIGH DOSAGE, AS OTHERWISE I WILL RELAPSE WITH CIDP SYMPTOMS RECURRING.
Age: 46.0
Sex: F
Vaccine: DTAP
Symptoms: Injected limb mobility decreased, Injection site pain
Clinical narrative: Have not been able to use my left arm without being in pain from injection site down the deltoid.  The shoulder muscle has become painful, due to not being able to use arm.  I am now in physical therapy twice weekly to try to regain mobility.  Still very painful.
Age: 69.0
Sex: M
Vaccine: VARZOS
Symptoms: Reaction to preservatives
Clinical narrative: I have a severe reaction to the shingle vaccine. I have been told by numerous doctors that it is the preservative in the vaccine that has caused my condition.
Age: 62.0
Sex: F
Vaccine: HEP
Symptoms: Abdominal pain upper, Asthenia, Cold sweat, Diarrhoea, Gait disturbance
Clinical narrative: Stomach cramps, cold sweat, when trying to walk to the restroom (I was at church) I drew the attention of others because I was staggering. From my perspective things were going black and I was  trying to get to the restroom before I passed out. Stool leakage before I made it to the toilet. Approximately 30 minutes confined to toilet with constant diarrhea. Too weak to walk to car. Had to be shuttled. Checked blood sugar it was 211. At home diarrhea continued along with waves of nausea. Blood sugar continued to climb even though I was not eating. Diarrhea continued through the night. Blood sugar continued to rise, even though I was only consuming chicken broth and a small amount of rice. Today, August 8, I still feel weak. My stomach aches, my blood sugar is now at 400, not sure if I have a slight fever.
Age: 62.0
Sex: F
Vaccine: HEP
Symptoms: Nausea, Pyrexia
Clinical narrative: Stomach cramps, cold sweat, when trying to walk to the restroom (I was at church) I drew the attention of others because I was staggering. From my perspective things were going black and I was  trying to get to the restroom before I passed out. Stool leakage before I made it to the toilet. Approximately 30 minutes confined to toilet with constant diarrhea. Too weak to walk to car. Had to be shuttled. Checked blood sugar it was 211. At home diarrhea continued along with waves of nausea. Blood sugar continued to climb even though I was not eating. Diarrhea continued through the night. Blood sugar continued to rise, even though I was only consuming chicken broth and a small amount of rice. Today, August 8, I still feel weak. My stomach aches, my blood sugar is now at 400, not sure if I have a slight fever.
Sex: U
Vaccine: PPV
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report as received from a nurse refers to unspecified patient of unknown age and gender. The patient's medical history and concurrent conditions were not reported. On an unknown date, the patient was vaccinated with improperly stored PNEUMOVAX 23 (lot #L019835, expiry date: 23-MAR-2017). No adverse reactions were reported. The outcome of the events was unknown. This is one of the two reports received from the same reporter. Additional information has been requested.
Sex: U
Vaccine: HIBV
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report as received from a nurse refers to unspecified patient of unknown age and gender. The patient's medical history and concurrent conditions were not reported. On an unknown date, the patient was vaccinated with improperly stored PEDVAXHIB (lot # M001813, expiry date: 14-OCT-2018) via intramuscular route (incorrect product storage). No adverse reactions were reported. The outcome of the events was unknown. This is one of the two reports received from the same reporter. Additional information has been requested.
Sex: U
Vaccine: HPV9
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: Information has been received from a Licensed Practical Nurse referring to multiple patients of unknown age and gender. The patients' medical history, concurrent condition and concomitant therapy were not provided. On unknown dates, the patients were vaccinated with doses of improperly stored GARDASIL 9 (lot# M004116, expiration date 12-OCT-2017, dose and route were not reported). There was no previous temperature excursion. Digital data logger involved. The vaccine had been stored under the lowest temperature of 0.8 Celsius degree for cumulative 2 hours and 41 minutes. 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, No adverse event
Clinical narrative: Information has been received from a Licensed Practical Nurse referring to multiple patients of unknown age and gender. The patients' medical history, concurrent condition and concomitant therapy were not provided. On unknown dates, the patients were vaccinated with doses of improperly stored RECOMBIVAX HB (lot # M001578, expiration date 21-NOV-2018, dose and route were not reported). There was no previous temperature excursion. Digital data logger involved. The vaccine had been stored under the lowest temperature of 0.8 Celsius degree for cumulative 2 hours and 41 minutes. No adverse effects were reported. This is one of several reports received from the same reporter. Additional information has been requested.
Sex: M
Vaccine: PPV
Symptoms: Inappropriate schedule of drug administration, No adverse event
Clinical narrative: Information has been received from the patient's sister referring to a male patient of unknown age. The patient's medical history included splenectomy in 2002 or 2003. The patient's concurrent condition and concomitant therapy were not reported. Since an unknown date in 2002, following the splenectomy, every 5 years for the past 15 years, the patient was vaccinated with a dose of PNEUMOVAX 23 (lot#, expiration date and route not reported). (Product use issue). The patient was due for his next injection of PNEUMOVAX 23 sometime next year. No adverse effect was reported. Additional information has been requested.
Sex: U
Vaccine: RV5
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: Information was received from certificated medical assistant referring to an unspecified number of patients of unknown age and gender. The patients' medical history, concurrent condition and concomitant therapy were not reported. On unknown dates starting on or after 09-JUN-2016, the patients were administered doses of improperly stored ROTATEQ (lot#L008054, expired on 30-NOV-2016; lot#L029618, expired on 30-NOV-2016 (dose and route unknown). The vaccines were exposed under 11.1 Celsius degree for 4 hours 25 minutes. There was no previous temperature excursion. Digital data logger was involved. No adverse effect was reported. This is one of several reports received from the same reporter. Additional information has been requested.
Sex: U
Vaccine: HIBV
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: Information has been received from a physician referring to multiple unspecified patients of unknown age and gender. On unspecified dates in February 2016 (reported as between 15-FEB-2016 and 23-FEB-2016), the patients were vaccinated with doses of improperly stored PEDVAXHIB (dose, route, lot# and expiration date were not reported). No adverse effects were reported. This is one of several reports received from the same reporter. Additional information has been requested.
Age: 69.0
Sex: F
Vaccine: PPV
Symptoms: Expired product administered, No adverse event
Clinical narrative: This spontaneous report was received from a pharmacist referring to a female patient of unknown age. The patient's medical history, concurrent conditions and concomitant medications were not reported. On 28-JUN-2016 the patient was vaccinated with PNEUMOVAX 23 (lot # K019386, expiration date 09-JUN-2016) intramuscular. The patient was vaccinated with an expired vaccine. No adverse effects were reported. The outcome of the event was unknown. Additional information has been requested.
Sex: F
Vaccine: VARCEL
Symptoms: Antibody test negative
Clinical narrative: This spontaneous report as received from a medical assistant refers to a no pregnant, 20 year old female patient. The patient's medical history, drug reactions, allergies and concurrent conditions were not reported. In approximately 2007 (when the patient was 11 years old), the patient was vaccinated with a dose of VARIVAX subcutaneous (dose, anatomical location, lot number and expiration date were not reported). In approximately 2016 (reported as at the age of 20), she was also vaccinated with a dose of VARIVAX subcutaneous (dose, anatomical location, lot number and expiration date were not reported). Concomitant therapies were not reported. On 22-JUN-2016, the patient had a lab work which revealed no reactive titers. The patient sought an unspecified medical attention. The outcome of the event was not reported. The relatedness between event and VARIVAX was not reported. Additional information has been requested.
Sex: F
Vaccine: MENB
Symptoms: Fatigue, Head discomfort
Clinical narrative: This case was reported by a physician via other manufacturer and described the occurrence of fatigue in a female patient who received BEXSERO. In June 2016, the patient received BEXSERO. In June 2016, less than a month after receiving BEXSERO, the patient experienced fatigue and heaviness of head. On an unknown date, the outcome of the fatigue and heaviness of head were recovered/resolved. It was unknown if the reporter considered the fatigue and heaviness of head to be related to BEXSERO. Additional details were provided as follows: The age at vaccination was not reported. The physician reported that her daughter received and injection of BEXSERO about a month ago and she experienced fatigue and heaviness of head that lasted a few days before resolving. The physician wanted to know if the patient could complete the series of BEXSERO using TRUMENBA. The reporter hung up the phone before she could ask for her address.
Sex: U
Vaccine: RAB
Symptoms: Nasal congestion, Rhinorrhoea
Clinical narrative: This case was reported by a physician via call center representative and described the occurrence of sniffles in a patient who received RABAVERT NVS. On an unknown date, the patient received the 2nd dose of RABAVERT. On an unknown date, 2 days after receiving RABAVERT, the patient experienced sniffles and nasal congestion. On 1st August 2016, the outcome of the sniffles and nasal congestion were recovered/resolved. The reporter considered the sniffles and nasal congestion to be unrelated to RABAVERT. Additional details were provided as follows: The age at vaccination was not reported. The physician mentioned when calling in for other information on vaccine. He said, he felt the events were not from the vaccine. No patient or product information was provided.
Sex: F
Vaccine: VARZOS
Symptoms: Injection site pain, Injection site rash
Clinical narrative: This spontaneous report was received from a pharmacist via company representative concerning a 65 year old female patient. Concomitant medication, pertinent medical history and drug reactions/allergies were reported as unknown. In January 2016 (reported as "about 6 months ago), the patient was vaccinated with a dose of ZOSTAVAX (lot number L046900) (dose, route, and expiration date reported as unknown). On an unknown date in 2016, the patient experienced a "rash the size of a baseball which was raised and painful" at the site of injection. The pharmacist reported that the patient did apply ice to the injection site and recovered on an unspecified date. The causality between the events and ZOSTAVAX was unknown. This is one of two cases from the same reporter. Additional information has been requested.
Age: 18.0
Sex: M
Vaccine: MENB
Symptoms: Chills, Injection site swelling, Tremor
Clinical narrative: This case was reported by a nurse via call center representative and described the occurrence of chills in a 18-year-old male patient who received BEXSERO (batch number 153701, expiry date 30th April 2017). Previously administered products included BEXSERO (No trouble). On 3rd June 2016, the patient received the 2nd dose of BEXSERO .5 ml. On 3rd June 2016, 3 hours after receiving BEXSERO, the patient experienced chills, injection site swelling and tremor. On 4th June 2016, the outcome of chills and tremor were recovered/resolved. On an unknown date, the outcome of the injection site swelling was recovered/resolved. The reporter considered the chills and tremor to be probably related to BEXSERO. The reporter considered the injection site swelling to be almost certainly related to BEXSERO. Additional details were provided as follows: Less than a day after receiving BEXSERO, the patient experienced injection site swelling. The reporter stated that, the patient had no trouble with first dose of BEXSERO.
Sex: U
Vaccine: HPV9
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: Information has been received from a nurse referring to an unspecified number of unspecified patients. Their medical history, concurrent condition and concomitant therapy were not provided. Since 21-JUL-2016, the patients have been administered doses of GARDASIL 9 (lot number and expiration reported as L037554, 25-DEC-2017 and M011117, 07-DEC-2017). All of which were improperly stored. No adverse effects have been reported. There was no prior excursion. This report is for data logger. Additional information has been reported.
Sex: U
Vaccine: HIBV
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: Information has been received from a nurse referring to an unspecified number of unspecified patients. Their medical history, concurrent condition and concomitant therapy were not provided. Since 21-JUL-2016, the patients have been administered doses of PEDVAXHIB (lot number and expiration reported as L042835, 19-AUG-2018 and M001814, 15-OCT-2018). All of which were improperly stored. No adverse effects have been reported. There was no prior excursion. This report is for data logger. Additional information has been requested.
Sex: U
Vaccine: RV5
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: Information has been received from a nurse referring to an unspecified number of unspecified patients. Their medical history, concurrent condition and concomitant therapy were not provided. Since 21-JUL-2016, the patients had been administered doses of ROTATEQ (lot number and expiration reported as L027719, 28-APR-2017 and L035636, 21-MAY-2017). All of which were improperly stored. No adverse effects have been reported. There was no prior excursion. This report is for data logger. 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 professional nurse referring to unspecified number of patients of unknown age and gender. Patients' pertinent medical history, drug reaction/allergies or concomitant information were not reported. On an unknown dates, the patients were vaccinated with an improperly stored doses of ROTATEQ Lot # L010844 - Expiration date: 16-NOV-2016 (strength, dose and route were not provided). No symptoms were reported. The reporter stated that duration of the event of incorrect product storage was about a time frame of 3 hours, and reported temperature was 58 degrees F. The vaccines did not undergo a previous temperature excursion. There was no data logger issue reported. This is one of several reports received from the same reporter. Additional information has been requested.
Sex: U
Vaccine: VARZOS
Symptoms: Expired product administered, No adverse event
Clinical narrative: This spontaneous report as received from registered nurse refers to a patient of unknown age and gender. The patient's concurrent conditions, medical history and concomitant medication use were not provided. On 11-JUL-2016 the patient was inadvertently administered an expired dose of ZOSTAVAX (lot # L011533, expiration date 03-JUL-2016). No adverse effect was reported. The outcome of the event was unknown. Additional information has been requested.
Sex: U
Vaccine: VARCEL
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: Information has been received from a Licensed Practical Nurse referring to multiple patients of unknown age and gender. The patients' medical history, concurrent condition and concomitant therapy were not provided. On unknown dates, the patients were vaccinated with doses of improperly stored VARIVAX (lot# M000760 with expiration date 06-JAN-2018, lot# M006722 with expiration date 08-FEB-2018, strength, dose and route were not expected). There was no previous temperature excursion. Digital data logger involved. The vaccine had been stored under the highest temperature of -11.4 Celsius degree for cumulative 4 hours. No adverse effects were reported. This is one of several reports received from the same reporter. Additional information has been requested.
Age: 19.0
Sex: F
Vaccine: MENB
Symptoms: Joint swelling, Oedema
Clinical narrative: This case was reported by a physician via sales rep and described the occurrence of pitting edema in a 19-year-old female patient who received BEXSERO (batch number 151401, expiry date 31st December 2016). On the 24th July 2016, the patient received BEXSERO. On 25th July 2016, 1 days after receiving BEXSERO, the patient experienced pitting edema and ankle swelling. On an unknown date, the outcome of the pitting edema and ankle swelling were recovering/resolving. The reporter considered the pitting edema and ankle swelling to be related to BEXSERO. Additional details were provided as follows: this case was previously reported to a doctor. The patient received the BEXSERO vaccine in left deltoid and next day when she woke up, she noted that both of her ankles were swollen, described as pitting edema. The field representative was unable to provide any further details. He stated that the patient was the reporting physician's daughter.
Age: 22.0
Sex: M
Vaccine: MENB
Symptoms: Injection site bruising, Injection site erythema, Injection site induration, Injection site swelling, Injection site warmth
Clinical narrative: This case was reported by a consumer via call center representative and described the occurrence of injection site induration in a 22-year-old male patient who received BEXSERO. On 27th July 2016, the patient received the 1st dose of BEXSERO. In July 2016, less than a week after receiving BEXSERO, the patient experienced injection site induration, injection site redness, injection site swelling, injection site warmth and injection site bruising. On an unknown date, the outcome of the injection site induration, injection site redness, injection site swelling, injection site warmth and injection site bruising were recovering/resolving. It was unknown if the reporter considered the injection site induration, injection site redness, injection site swelling, injection site warmth and injection site bruising to be related to BEXSERO. Additional details were provided as follows: On 27th July 2016 (Wednesday), around noon, the patient received the 1st dose of BEXERO and showed his arm to his mother on Friday. The patient experienced injection site reactions in the arm where he received a dose of BEXSERO. The patient had an induration with a large red swollen area the looked like bull's eye. It was also hot to touch. The patient's mother noted a bruise in the area. The reporter stated that, she measured the size of reaction and from top to bottom it was 2 inches and across it was 2.5 to 3 inches. As of 1st August 2016, the events were improved but had not gone away.
Age: 75.0
Sex: F
Vaccine: PNC13
Symptoms: Erythema, Induration, Rash, Swelling
Clinical narrative: Swelling, rash > within 2 days of immunization. Induration = 3 x 4 mm. Erythema = 3 x 3 mm.
Sex: F
Vaccine: HIBV, MMR, VARCEL
Symptoms: Irritability, Rash
Clinical narrative: Rash, fussy (mom has photos she can send). Rash appeared 7 days after vaccines; amox given. Rash now resolving.
Age: 12.0
Sex: M
Vaccine: HEPA, HPV9, MNQ, TDAP
Symptoms: Erythema, Rash
Clinical narrative: Pt presented to clinic 8/8/16 w/ father, reported "rash" was noticed (L) upper back 8/6/16; pt was taken to Dr. and prescribed "ZYRTEC, BENADRYL, and "some cream", pt reported that "rash" spreading to (R) upper back later (after 8-6-16) and treated w/same meds. At inspection 8/8/16  redness noted to (R) upper back.
Sex: U
Vaccine: HEP
Symptoms: Hepatitis B antibody negative, Therapy non-responder
Clinical narrative: This case was reported by a nurse via other manufacturer and described the occurrence of therapy non-responder in a patient who received ENGERIX B. On an unknown date, the patient received ENGERIX B at an unknown dose. On an unknown date, an unknown time after receiving ENGERIX B, the patient experienced therapy non-responder. On an unknown date, the outcome of the therapy non-responder was unknown. It was unknown if the reporter considered the therapy non-responder to be related to ENGERIX B. Additional details were provided as follows: The nurse reported that an unspecified patient was non-responder after receiving an unspecified number of ENGERIX B on unspecified dates. No further information was provided.
Age: 4.0
Sex: F
Vaccine: DTAP, IPV, MMR, VARCEL
Symptoms: Injection site rash, Rash erythematous, Swelling
Clinical narrative: Pt left office, came back about 10 mins later with red swollen rash on face and spots on back and injection site. Pt was given BENADRYL in office.
Age: 67.0
Sex: F
Vaccine: PNC13
Symptoms: Injection site discolouration
Clinical narrative: Pt came in on 5/23/16 states that after receiving PCV13 she had a discoloration of the upper arm at injection site left deltoid.
Age: 28.0
Sex: M
Vaccine: RAB, TDAP
Symptoms: Arthralgia, Dizziness, Malaise, Nausea, Pyrexia
Clinical narrative: 12 hrs after vaccine developed diffuse joint pain , nausea, malaise, then fever, d 12, dizziness - no IgE mediated 2nd dose of rabies on 8/1/16 yielded similar reaction for 2-3 days. No sequelae. He declined 3rd dose of prophylactive HDCV.
Age: 75.0
Sex: F
Vaccine: PNC13
Symptoms: Diarrhoea, Dizziness, Nausea, Vomiting
Clinical narrative: Pt. c/o severe nausea, vomiting, diarrhea and dizziness. Visit to primary care physician on 8/5/16; tx. with injectable for nausea/vomiting; RX. for PO PHENERGAN. Pt. stated reactions lasted approx. 24 hrs.
Age: 62.0
Sex: F
Vaccine: TDAP
Symptoms: Drug administered at inappropriate site, Hypoaesthesia, Paraesthesia
Clinical narrative: Patient has reported that she is experiencing numbness and tingling in fingers of left arm. She visited doctor on 8/4 or 8/5 and was told the injection was given on a nerve. She was told to call doctor back if the symptoms do not go away or increase.
Age: 0.3
Sex: F
Vaccine: DTAP
Symptoms: Seizure
Clinical narrative: Seizure.
Age: 17.0
Sex: M
Vaccine: HPV9, HPV9
Symptoms: Asthenia, Chills, Extra dose administered, Fatigue, Headache
Clinical narrative: Pt inadvertently received 4th dose of GARDASIL vaccine by mistake on 8/4/16. 12 hrs after injection felt feverish, chills, headache, weak, myalgias and fatigue. By 8/6 felt better and was back to baseline by 8/8.
Age: 17.0
Sex: M
Vaccine: HPV9, HPV9
Symptoms: Myalgia, Pyrexia
Clinical narrative: Pt inadvertently received 4th dose of GARDASIL vaccine by mistake on 8/4/16. 12 hrs after injection felt feverish, chills, headache, weak, myalgias and fatigue. By 8/6 felt better and was back to baseline by 8/8.
Age: 17.0
Sex: M
Vaccine: HPV9, HPV9
Symptoms: Asthenia, Chills, Fatigue, Headache, Myalgia
Clinical narrative: Pt inadvertently received 4th dose of GARDASIL vaccine by mistake on 8/4/16. 12 hrs after injection felt feverish, chills, headache, weak, myalgias and fatigue. By 8/6 felt better and was back to baseline by 8/8.
Age: 17.0
Sex: M
Vaccine: HPV9, HPV9
Symptoms: Pyrexia
Clinical narrative: Pt inadvertently received 4th dose of GARDASIL vaccine by mistake on 8/4/16. 12 hrs after injection felt feverish, chills, headache, weak, myalgias and fatigue. By 8/6 felt better and was back to baseline by 8/8.
Age: 56.0
Sex: M
Vaccine: PNC13
Symptoms: Injected limb mobility decreased, Pain
Clinical narrative: Patient received PREVNAR in the (R) deltoid and he is unable to lift the arm without pain.
Age: 5.0
Sex: F
Vaccine: DTAPIPV, MMRV
Symptoms: Injection site erythema, Injection site oedema, Injection site pain, Injection site swelling, Injection site warmth
Clinical narrative: Evening of 8/2/16 child had fever 102°F-Mom gave ibuprof. AM of 8/3/16 child had swelling, redness, tenderness and warmth to left distal upper arm - ice applied. 8/4/16 child seen in office 6 cm x 7 cm area lateral lower upper (L) arm with moderate edema and redness - BENADRYL ordered.
Age: 5.0
Sex: F
Vaccine: DTAPIPV, MMRV
Symptoms: Pyrexia
Clinical narrative: Evening of 8/2/16 child had fever 102°F-Mom gave ibuprof. AM of 8/3/16 child had swelling, redness, tenderness and warmth to left distal upper arm - ice applied. 8/4/16 child seen in office 6 cm x 7 cm area lateral lower upper (L) arm with moderate edema and redness - BENADRYL ordered.
Age: 21.0
Sex: M
Vaccine: MENB
Symptoms: Asthenia, Chills, Fatigue, Injection site pain
Clinical narrative: Pain at injection site, tired/weak, chills.
Age: 67.0
Sex: F
Vaccine: FLUX
Symptoms: Pain in extremity
Clinical narrative: Pain in left arm. Post flu shot.
Age: 34.0
Sex: F
Vaccine: VARCEL
Symptoms: Hypoaesthesia, Injection site erythema, Injection site pain, Injection site pruritus, Injection site swelling
Clinical narrative: Redness, swelling, pain, itching to left upper extremity along with numbness and tingling in left arm. Onset of symptoms on 8-4-16 at 2:00 PM.
Age: 34.0
Sex: F
Vaccine: VARCEL
Symptoms: Paraesthesia
Clinical narrative: Redness, swelling, pain, itching to left upper extremity along with numbness and tingling in left arm. Onset of symptoms on 8-4-16 at 2:00 PM.
Age: 4.0
Sex: F
Vaccine: DTAPIPV, MMRV
Symptoms: Injection site erythema, Injection site pain, Injection site rash, Injection site warmth
Clinical narrative: Patient stated with red, warm rash at injection site today August 7. Woke up this am with rash, not worsening. No rash last night at bedtime. Tender, not itchy. Rash around, 2" x 1" right outer thigh.  Will treat with ice and BENADRYL.
Age: 4.0
Sex: M
Vaccine: DTAP, IPV, MMR, VARCEL
Symptoms: Injection site erythema, Injection site swelling
Clinical narrative: Left upper arm: Deltoid injection site (DTAP) is surrounded by approx 3-4cm of faint erythema and swelling, extending more than below. Non tender normal ROM of arm. Less injected/swollen in are that was under the Band-Aid.
Age: 10.0
Sex: M
Vaccine: TD, VARCEL
Symptoms: Erythema, Pain, Peripheral swelling, Skin warm
Clinical narrative: (R) deltoid arm/swelling within 24 hours, seen 3 days later decreased swelling and pain. 5 cm x 5 cm of erythema, warmth.
Age: 57.0
Sex: M
Vaccine: VARZOS
Symptoms: Herpes zoster, Ophthalmic herpes zoster
Clinical narrative: Pt has herpes zoster/shingles in eye.
Age: 11.0
Sex: F
Vaccine: HPV9, MNQ, TDAP
Symptoms: Crying, Dizziness, Vomiting
Clinical narrative: Cried and thrashed around during vaccines. Gave water after vaccines were administered and child immediately vomited (water) was a little dizzy and recovered after lying down.
Age: 0.18
Sex: F
Vaccine: DTAPIPVHIB, PNC13, RV1
Symptoms: Injection site erythema, Injection site swelling
Clinical narrative: Pt has swelling and redness (20cmX20cm) Lt thigh mom noticed 20 mins. ago. (around 0105PM) Continually crying since swelling.
Age: 0.17
Sex: M
Vaccine: DTAPHEPBIP, HIBV, PNC13, RV5
Symptoms: Injection site mass
Clinical narrative: Lump in Rt thigh now gone. No interventions needed.
Age: 11.0
Sex: F
Vaccine: HPV4
Symptoms: Back pain, Biopsy, Blood test, Bone scan, Computerised tomogram
Clinical narrative: Pain in lower back. Pain and outgrowth of lower right mandible (jaw). Time course 10 years. Treatment; Biopsies, injections, medications, P. therapy, OMT treatments, MRIs, X-rays, Bone scans, C.T. scans, Bone Density tests, Blood tests, Acupuncture, Pain management injections.
Age: 11.0
Sex: F
Vaccine: HPV4
Symptoms: Jaw disorder, Nuclear magnetic resonance imaging, Pain in jaw, X-ray
Clinical narrative: Pain in lower back. Pain and outgrowth of lower right mandible (jaw). Time course 10 years. Treatment; Biopsies, injections, medications, P. therapy, OMT treatments, MRIs, X-rays, Bone scans, C.T. scans, Bone Density tests, Blood tests, Acupuncture, Pain management injections.
Sex: F
Vaccine: FLU3
Symptoms: Injection site mass
Clinical narrative: Initial unsolicited report received from a non-healthcare professional  on 21 November 2015. This case involved a female patient (age was not reported) who was vaccinated with an intramuscular dose of  FLUZONE HD (batch number was unknown dose and dose in series was not reported) in right deltoid on an unspecified date in 2014. Illness at time of vaccination and pre-existing physician diagnosed allergies, birth defects, medical conditions were reported as unknown. Concomitant medications were not reported. On unspecified date in 2014, following the vaccination, the patient developed vaccination site mass (one inch diameter). Lab data and corrective treatments were not provided. The patient was not recovered from the event. List of documents held by sender: none.
Age: 71.0
Sex: M
Vaccine: FLU3, PNC13, FLU3, PNC13
Symptoms: Injected limb mobility decreased, Pain in extremity
Clinical narrative: Initial unsolicited report received from a pharmacist on 02 December 2015. This case involves a 71-years-old male patient who was vaccinated with an injection of 0.5 ml of Fluzone HD (batch number- UI491AA, Expiry date- 18 Jun 2016, dose in series was not reported) via intramuscular route in left arm and with an injection of 0.5 ml of PREVNAR 13 (manufacturer: Pfizer, batch number- M1306B, Expiry date- April 2017, dose in series was not reported) via intramuscular route in right arm both on 14 November 2015. The patient's medical history and concomitant medications were not reported. On an unknown date, following the vaccination, the patient's right or left arm was sore and had limited movement. Laboratory data and corrective treatments were not reported. The patient was not recovered from the events. List of documents held by sender: none.
Age: 71.0
Sex: M
Vaccine: FLU3, PNC13, FLU3, PNC13
Symptoms: Injected limb mobility decreased, Injection site pain
Clinical narrative: Initial unsolicited report received from a pharmacist on 02 December 2015. This case involves a 71-years-old male patient who was vaccinated with an injection of 0.5 ml of Fluzone HD (batch number- UI491AA, Expiry date- 18 Jun 2016, dose in series was not reported) via intramuscular route in left arm and with an injection of 0.5 ml of PREVNAR 13 (manufacturer: Pfizer, batch number- M1306B, Expiry date- April 2017, dose in series was not reported) via intramuscular route in right arm both on 14 November 2015. The patient's medical history and concomitant medications were not reported. On an unknown date, following the vaccination, the patient's right or left arm was sore and had limited movement. Laboratory data and corrective treatments were not reported. The patient was not recovered from the events. List of documents held by sender: none.
Age: 62.0
Sex: M
Vaccine: FLU4
Symptoms: Rhinorrhoea
Clinical narrative: Initial unsolicited report received from a consumer on 11-Dec-2015. This case involves a 62-year-old male patient who was vaccinated with an intramuscular 0.5 ml dose of FLUZONE QUAD (batch number and site of administration was not reported) on 10-Dec-2015. Medical history and concomitant medications were not reported. On 11-Dec-2015, 24 hours after vaccination, the patient experienced that his nose started running. No Laboratory investigations were reported. Corrective treatments were not reported. The outcome of the event runny nose was reported as unknown. Causality for the event runny nose was assessed as unknown by the reporter. Documents held by sender: none. Follow-up information received from a consumer on 25 January 2016. No new information was provided.
Age: 70.0
Sex: F
Vaccine: FLU3, FLU3
Symptoms: Mobility decreased, Pain in extremity
Clinical narrative: Initial unsolicited report received from a Pharmacist on 13 January 2016. This case involves 70-year-old female patient who was vaccinated with a first dose of FLUZONE HD (batch umber- UI489AA, expiry date - 02 June 2016) intramuscularly on left deltoid on 04 December 2015. The patient's medical history includes diabetes and had received oral hypoglycemic and allergy to neomycin. Patient denied to provide illness at the time of vaccination. The patient's concomitant medications were not provided. On 07 December 2015, three days following the vaccination, the patient had difficulty in raising her left arm over her head. It was reported that, the patient slept on her left side. Laboratory data and corrective treatment were not reported. The outcome of event was reported as unknown. List of documents held by sender: none. Follow up report received from healthcare professional on 04 March 2016. On 14 January 2016, patient had X-ray examination. It was reported that, patient had received physical therapy on 19 January 2016. It was updated that the injection was given at pharmacy.
Age: 70.0
Sex: F
Vaccine: FLU3, FLU3
Symptoms: Injected limb mobility decreased, X-ray
Clinical narrative: Initial unsolicited report received from a Pharmacist on 13 January 2016. This case involves 70-year-old female patient who was vaccinated with a first dose of FLUZONE HD (batch umber- UI489AA, expiry date - 02 June 2016) intramuscularly on left deltoid on 04 December 2015. The patient's medical history includes diabetes and had received oral hypoglycemic and allergy to neomycin. Patient denied to provide illness at the time of vaccination. The patient's concomitant medications were not provided. On 07 December 2015, three days following the vaccination, the patient had difficulty in raising her left arm over her head. It was reported that, the patient slept on her left side. Laboratory data and corrective treatment were not reported. The outcome of event was reported as unknown. List of documents held by sender: none. Follow up report received from healthcare professional on 04 March 2016. On 14 January 2016, patient had X-ray examination. It was reported that, patient had received physical therapy on 19 January 2016. It was updated that the injection was given at pharmacy.
Age: 61.0
Sex: F
Vaccine: FLU3, HEPA, YF, FLU3, HEPA, YF
Symptoms: Computerised tomogram, Hypoaesthesia, Immediate post-injection reaction, Laboratory test, Leg amputation
Clinical narrative: Case number PHHY2016US106020, is an initial spontaneous report received Vaccine Adverse Event Reporting System (VAERS reference number: 637605) website on 01 Aug 2016. This report refers to a 61 years old female patient. Past medical history was not reported. Current conditions included as penicillin allergy and chronic idiopathic thrombocytopenic purpura. Concomitant medications included as calcium, vitamin and Vitamin D3. The patient was vaccinated with FLUVIRIN 2015/2016 (batch number: not reported) into left arm, intramuscularly, HAVRIX vaccine (other manufacture, batch number: A4M5L) into left arm, intramuscularly and YF-VAX (other manufacture, batch number: Ui095AA) into right arm, on 11 Dec 2015. On 22 Dec 2015, the patient experienced immediate pain in right calf, proceeding to numbness, coldness, and pain in right foot, blood clot (no vascular disease) discovered and subsequent amputation below the knee. The patient visited the emergency room and was hospitalized for 15 days. The patient computed tomography (CT) scan was done subsequently tests to rule out other diagnoses. The outcome of events was reported as condition unchanged. The seriousness of events was reported as serious (hospitalized and disability). The causality of events was not reported. Follow up report received from a quality assurance (QA) department on 09 Aug 2016: QA confirmed that, previously reported batch number (151750) was not valid FLUVIRIN batch number.
Age: 61.0
Sex: F
Vaccine: FLU3, HEPA, YF, FLU3, HEPA, YF
Symptoms: Pain in extremity, Peripheral coldness, Thrombosis
Clinical narrative: Case number PHHY2016US106020, is an initial spontaneous report received Vaccine Adverse Event Reporting System (VAERS reference number: 637605) website on 01 Aug 2016. This report refers to a 61 years old female patient. Past medical history was not reported. Current conditions included as penicillin allergy and chronic idiopathic thrombocytopenic purpura. Concomitant medications included as calcium, vitamin and Vitamin D3. The patient was vaccinated with FLUVIRIN 2015/2016 (batch number: not reported) into left arm, intramuscularly, HAVRIX vaccine (other manufacture, batch number: A4M5L) into left arm, intramuscularly and YF-VAX (other manufacture, batch number: Ui095AA) into right arm, on 11 Dec 2015. On 22 Dec 2015, the patient experienced immediate pain in right calf, proceeding to numbness, coldness, and pain in right foot, blood clot (no vascular disease) discovered and subsequent amputation below the knee. The patient visited the emergency room and was hospitalized for 15 days. The patient computed tomography (CT) scan was done subsequently tests to rule out other diagnoses. The outcome of events was reported as condition unchanged. The seriousness of events was reported as serious (hospitalized and disability). The causality of events was not reported. Follow up report received from a quality assurance (QA) department on 09 Aug 2016: QA confirmed that, previously reported batch number (151750) was not valid FLUVIRIN batch number.