chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 67.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site rash, Injection site warmth, Rash, Tenderness
Clinical narrative: This spontaneous report as received from a consumer refers to a 67 year old female patient. There were no drug reactions/allergies. On 19-JUL-2014 the patient was vaccinated with ZOSTAVAX (dose, frequency and lot # unspecified) in the left arm. Other suspect therapies included prednisone (manufacturer unknown). Concomitant therapies included SYMBICORT. On 20-JUL-2014, about 24 hours after vaccination, the patient experienced hard, arm tender knot at the injection site. She stated that her arm was tender for about 2 weeks. On 28-JUL-2014, patient had to have a CAT scan. On approximately 25-JUL-2014 (also reported as 3 days prior to CAT scan), she had to take prednisone (manufacturer unknown. On 04-AUG-2014 the patient experienced rash developed at injection site and on the back of her legs. Rash was only on left side of her body. On an date in 2014, patient had back pain as well, the patient was concerned that prednisone (manufacturer unknown) could have caused this reaction, since she had to take this so shortly after ZOSTAVAX vaccination. No lab diagnostics were performed. The outcome of events was unknown. The patient did not receive any treatment for the events. The patient did not seek medical attention. Product quality complaint was not involved. The reporter considered hard, warm tender knot at the injection site, arm was tender, rash developed at injection site and on the back of her legs with ZOSTAVAX was unknown. Additional information has been requested.
Sex: U
Vaccine: HPV4
Symptoms: Incorrect storage of drug, No adverse event
Clinical narrative: This spontaneous report as received from a nurse refers to unspecified patients. The patients medical history was not reported. On an unknown date the unspecified patients were vaccinated with doses of GARDASIL that were exposed to a supported temperature excursion on unspecified dates. No adverse experience has been observed or reported. No product quality complaint (PQC) was reported for GARDASIL. Follow up information has been received from a registered nurse. The reporter stated that on 13-AUG-2014 one of the patients was administered with GARDASIL lot # J014219 and expiration date 05-OCT-2015. This is one of several reporters from the same source. Additional information has been requested.
Sex: U
Vaccine: MMR
Symptoms: Incorrect storage of drug, No adverse event
Clinical narrative: This spontaneous report as received from an office manager refers to a unspecified number of patients of unknown age and gender. Approximately in August 2014, reported as after 18-AUG-2014, the patient's were vaccinated with M-M-R II. Dose, route, lot number and expiration date were not reported. Approximately in August 2014, reported as after 18-AUG-2014, improperly stored  M-M-R II was administered. No adverse effects were noted. This is one of several reports from the same source. Additional information has been requested.
Age: 76.0
Sex: F
Vaccine: FLU3, PPV
Symptoms: Injection site pain, Musculoskeletal pain, Pain in extremity
Clinical narrative: Patient reported severe pain in the right arm and shoulders.
Age: 13.0
Sex: F
Vaccine: FLUN4
Symptoms: Asthenia, Dizziness, Feeling abnormal, Heart rate increased
Clinical narrative: Mother called nurse triage line at 4:28pm 9/8/2014. Patient was experiencing dizziness, weak, rapid heart rate and said she was not feeling good.
Age: 15.0
Sex: F
Vaccine: HPV4
Symptoms: Dizziness, Fall, Headache, Heart rate decreased, Loss of consciousness
Clinical narrative: I administered the HPV vaccine (Lot: K001631 exp: Nov 6, 2016) to patient on September 8, 2014 in room. Patient was sitting on the exam table when I arrived to administer the HPV vaccine. I inquired if she would like to lie down on the exam table while I administered the vaccine due to past experiences of dizziness after HPV administration. Patient declined and reported that she did not like vaccines and would like to get it over with. Patient's mother was in the room at the time of the vaccine trying to provide distraction to the patient during while I administered the vaccine. After vaccine was administered I inquired how she felt and patient reported that she felt well. I then answered two additional questions patient's mother had and then proceed to leave the exam room with patient sitting on the exam table and mother in the room. About 1-2 minutes later a loud noise came from exam room. Myself, four additional nurses and Dr. immediately went to attend to patient. Patient was found on the ground with LOC for about 3 seconds. She became responsive with a complaint of head and neck pain. Ice, water, ADVIL (4 tsp PO) and rest for 20 minutes. Patient's mother reported that patient was stepping down from the step stool and then fell to the floor. I remained with the patient for 10 minutes and returned every 5 minutes for 10 minutes thereafter. Patient was able to speak with myself and her mother during this time. With the assistance of another nurse, we sat patient up to a chair where she denied any new pain or discomfort. Dr. then completed a brief head and neck exam. Patient appeared to be tolerating the exam with a complaint of neck pain. I stepped out of the room leaving patient safely sitting in a chair with Dr., another nurse and her mother. I was soon called back into the exam room by another nurse who then called the paramedics. With this second syncopal episode patient LOC for about 6 seconds and was then responsive and able to accurately answer questions. Her rate and oxygen were monitored (HR: 43 and O2: 100%). Patient appeared pale and was given oxygen via facemask on 0.5 L. Her color quickly improved and heart rate increased. The paramedics arrived shortly after and took report from Dr. and care of patient, who was then transported to ER for neck imaging.
Age: 15.0
Sex: F
Vaccine: HPV4
Symptoms: Neck pain, Pallor, Syncope, X-ray normal
Clinical narrative: I administered the HPV vaccine (Lot: K001631 exp: Nov 6, 2016) to patient on September 8, 2014 in room. Patient was sitting on the exam table when I arrived to administer the HPV vaccine. I inquired if she would like to lie down on the exam table while I administered the vaccine due to past experiences of dizziness after HPV administration. Patient declined and reported that she did not like vaccines and would like to get it over with. Patient's mother was in the room at the time of the vaccine trying to provide distraction to the patient during while I administered the vaccine. After vaccine was administered I inquired how she felt and patient reported that she felt well. I then answered two additional questions patient's mother had and then proceed to leave the exam room with patient sitting on the exam table and mother in the room. About 1-2 minutes later a loud noise came from exam room. Myself, four additional nurses and Dr. immediately went to attend to patient. Patient was found on the ground with LOC for about 3 seconds. She became responsive with a complaint of head and neck pain. Ice, water, ADVIL (4 tsp PO) and rest for 20 minutes. Patient's mother reported that patient was stepping down from the step stool and then fell to the floor. I remained with the patient for 10 minutes and returned every 5 minutes for 10 minutes thereafter. Patient was able to speak with myself and her mother during this time. With the assistance of another nurse, we sat patient up to a chair where she denied any new pain or discomfort. Dr. then completed a brief head and neck exam. Patient appeared to be tolerating the exam with a complaint of neck pain. I stepped out of the room leaving patient safely sitting in a chair with Dr., another nurse and her mother. I was soon called back into the exam room by another nurse who then called the paramedics. With this second syncopal episode patient LOC for about 6 seconds and was then responsive and able to accurately answer questions. Her rate and oxygen were monitored (HR: 43 and O2: 100%). Patient appeared pale and was given oxygen via facemask on 0.5 L. Her color quickly improved and heart rate increased. The paramedics arrived shortly after and took report from Dr. and care of patient, who was then transported to ER for neck imaging.
Sex: U
Vaccine: RV5
Symptoms: Incorrect storage of drug, No adverse event
Clinical narrative: This spontaneous report was received from a healthcare worker referring to an unknown number of patients that may have been vaccinated with a dose of ROTATEQ (dose, route and lot # not reported). The healthcare worker reported that on unknown number of doses of ROTATEQ that were exposed to 10 degrees C for 1 hour and 17 minutes then exposed to 8.7 degrees C for 28 minutes may have been administered. No adverse effect reported. This is one of two reports from the same reporter source. Additional information is not expected due to no other information was available at the time of the report.
Sex: U
Vaccine: VARCEL
Symptoms: Incorrect storage of drug, No adverse event
Clinical narrative: This spontaneous report as received from an office manager refers to a unspecified number of patients of unknown age and gender. Approximately in August 2014, reported as after 18-AUG-2014, the patients were vaccinated with (Oka/Merck) VARIVAX. Dose, route, lot number and expiration date were not reported. Approximately in August 2014, reported as after 18-AUG-2014, improperly stored (Oka/Merck) VARIVAX was administered. No adverse effects were noted. This is one of several reports from the same source. Additional information has been requested.
Age: 20.0
Sex: F
Vaccine: HPV4
Symptoms: Influenza like illness, Polyarthritis, Rheumatoid arthritis, Rheumatoid factor increased
Clinical narrative: Patient developed flu like symptoms and crippling polyarthritis that was later diagnosed as Rheumatoid Arthritis.
Age: 72.0
Sex: F
Vaccine: FLU3
Symptoms: Injection site erythema, Injection site swelling, Injection site warmth
Clinical narrative: Patient had s/s of redness and swelling with heat on the left deltoid area. She didn't complain of any itching or pain. The area of redness and swelling had a diameter of roughly 5 inches. On the following day the swelling moved down to the elbow area, but swelling around  the deltoid area has decreased.
Age: 63.0
Sex: M
Vaccine: VARZOS
Symptoms: Arthralgia, Chills, Paraesthesia, Pyrexia
Clinical narrative: Mid grade fever 100.7. Chills, achy Joints (especially Rt. knee) tingling feeling all over. Lasted till 09-08-2014.  Treated with 650 Tylenol.
Age: 12.0
Sex: M
Vaccine: MNQ
Symptoms: Diarrhoea
Clinical narrative: Within 1-2 hrs of receiving vaccine the patient developed profuse diarrhea that lasted approx. 36 hrs. No vomiting, no respiratory and no skin reactions.
Age: 87.0
Sex: F
Vaccine: FLU3
Symptoms: Eyelid oedema, Lip swelling, Swelling face
Clinical narrative: Patient received FLUZONE HIGH DOSE vaccine in the office, by the time she arrived home she had facial, lip and eyelid swelling. She then drove herself to the ER.
Age: 6.0
Sex: F
Vaccine: FLU3
Symptoms: Excessive eye blinking
Clinical narrative: Eye blinking.
Age: 28.0
Sex: F
Vaccine: FLU3
Symptoms: Injection site erythema, Joint range of motion decreased, Pain
Clinical narrative: Developed erythema at injection with decreased ROM and pain, but no tenderness. Treated with NAPROSYN for 5 days with great improvement, then day 6, is c/o pain (L) supraspinatus. Referred to orthopedics.
Age: 42.0
Sex: F
Vaccine: TD
Symptoms: Injection site erythema, Injection site pruritus, Injection site swelling
Clinical narrative: Day after receiving TD on 8/4/14, her entire (L) upper arm became red, swollen and itchy. She used ice packs and BENADRYL. Problem resolved in a few days. She is a Post Bone Marrow Transplant patient and the dose of TD given 8/4/14 was her 3rd dose post transplant.
Sex: M
Vaccine: HEP
Symptoms: Incorrect storage of drug, No adverse event
Clinical narrative: This spontaneous report was received from the registered nurse refers to an unknown number of patients of unknown age and gender. On an unknown date, the patient was vaccinated with RECOMBIVAX HB (dose, route, and lot were not reported). On an unknown date, the patients received improperly stored RECOMBIVAX HB. No adverse symptoms reported. At the time of the report the action taken was not reported. All telephone attempts to obtain follow-up information have been unsuccessful. Additional information was received from a registered nurse concerning a 1 day ale patient. Patient's birth weight was 6 lbs 4 oz with 4 siblings. Patient was vaccinated with RECOMBIVAX HB the same day that he was born (21-MAY-2014) at 19:56 PM. Lot  number J012520; Exp. Date: 30-JAN-2016. The vaccine storage temp dropped to 0-1 degrees on 18 different episodes between May 14th and July 21st (unspecified year) according to min/max. All recorded temperatures are within 2-8 degrees. Additional information is not expected since all follow ups requested to complete the case were received.
Sex: U
Vaccine: HIBV
Symptoms: Incorrect storage of drug, No adverse event
Clinical narrative: This spontaneous report as received from an office manager refers to a unspecified number of patients of unknown age and gender. Approximately in August 2014, reported as after 18-AUG-2014, the patients were vaccinated with LIQUID PEDVAXHIB. Dose, route, lot number and expiration date were not reported. Approximately in August 2014, reported as after 18-AUG-2014, improperly stored LIQUID PEDVAXHIB was administered. No adverse effects were noted. This is one of several reports from the same source.  Additional information has been requested.
Age: 65.0
Sex: F
Vaccine: PPV
Symptoms: Expired drug administered, No adverse event
Clinical narrative: This spontaneous report as received from a pharmacist refers to a 65 year old female patient. On 27-AUG-2014, the patient was vaccinated with an expired dose of PNEUMOVAX23 (dose, route of administration and lot # were not provided) (expiration date: 03-AUG-2014). No adverse effects were reported. Additional information has been requested.
Age: 30.0
Sex: M
Vaccine: TDAP
Symptoms: Arthroscopic surgery, Imaging procedure, Joint injection, Musculoskeletal pain
Clinical narrative: Persistent shoulder pain. Ended up receiving shoulder injection and later shoulder arthroscopic surgery.
Age: 1.02
Sex: F
Vaccine: FLU3, HEPA, MMR, VARCEL
Symptoms: Irritability, Pyrexia, Rash erythematous, Rash generalised
Clinical narrative: Fussy and fever the following day after receiving vaccines.  This lasted for five days then was followed by a red non itchy rash over entire body.
Age: 13.0
Sex: F
Vaccine: MEN, TDAP
Symptoms: Dyskinesia, Fall
Clinical narrative: Fell back and had 3-4 arm/legs jerking movements, right after getting the HPV vaccine.
Age: 22.0
Sex: M
Vaccine: HPV4
Symptoms: Chest discomfort, Chest pain, Dyskinesia, Electrocardiogram, Eye movement disorder
Clinical narrative: Administered Gardasil 0.5 ML IM in left upper deltoid while patient was sitting upright on exam table.  Nurse walked to patient right side.  Patient mumbled something, eyes rolled back into head and pt had a + LOC. Nurse called for assistance. Assisted pt to a lying position. Patient began having jerking movements of extremities x 5 seconds. Patient regained consciousness quickly and became alert and oriented to person, place and time. PA and MD made aware and assessed patient. Patient assisted to a sitting position after 15 minutes of lying down, he immediately complained of chest pressure and pain.  EKG obtained. PA made aware of results. EMS called. Patient transfered to ER via EMS.
Age: 22.0
Sex: M
Vaccine: HPV4
Symptoms: Loss of consciousness
Clinical narrative: Administered Gardasil 0.5 ML IM in left upper deltoid while patient was sitting upright on exam table.  Nurse walked to patient right side.  Patient mumbled something, eyes rolled back into head and pt had a + LOC. Nurse called for assistance. Assisted pt to a lying position. Patient began having jerking movements of extremities x 5 seconds. Patient regained consciousness quickly and became alert and oriented to person, place and time. PA and MD made aware and assessed patient. Patient assisted to a sitting position after 15 minutes of lying down, he immediately complained of chest pressure and pain.  EKG obtained. PA made aware of results. EMS called. Patient transfered to ER via EMS.
Sex: U
Vaccine: MMRV
Symptoms: Incorrect storage of drug, No adverse event
Clinical narrative: This spontaneous report as received from an office manager refers to a unspecified number of patients of unknown age and gender. Approximately in August 2014, reported as after 18-AUG-2014, the patients were vaccinated with PROQUAD (Merck). Dose, route, lot number and expiration date were not reported. Approximately in August 2014, reported as after 18-AUG-2014, improperly stored PROQUAD (Merck) was administered. No adverse effects were noted. This is one of several reports from the same source. Additional information has been requested.
Age: 66.0
Sex: M
Vaccine: FLU3
Symptoms: Computerised tomogram, Face oedema, Lymphadenopathy, Nasopharyngitis, Sinus disorder
Clinical narrative: Initial sinus/cold symptoms within about 12 hours.  The next day, edema on left side of face; evenually left side of face involved.  All lymph's nodes on right side of face to chin enlarged.
Age: 81.0
Sex: M
Vaccine: FLUC3
Symptoms: Cough, Fatigue, Headache, Myalgia, Oropharyngeal pain
Clinical narrative: HA, SORE THROAT, DRY COUGH, FATIGUE, MILD MYALGIAS. TX WITH TAMIFLU 9/7/14.
Age: 56.0
Sex: M
Vaccine: FLU4
Symptoms: Erythema, Local swelling, Skin warm, Urticaria
Clinical narrative: Arm was slightly swollen, red, and hot with welps; did not report problems breathing.
Age: 3.0
Sex: F
Vaccine: DTAP, HIBV
Symptoms: Injection site erythema, Injection site pain, Injection site swelling
Clinical narrative: Left shoulder slightly swollen, red, tender.
Age: 27.0
Sex: F
Vaccine: TDAP
Symptoms: Musculoskeletal pain, Pain in extremity
Clinical narrative: Pain in shoulder and down arm.
Age: 11.0
Sex: F
Vaccine: HPV4
Symptoms: Abdominal distension, Abdominal pain, Headache, Nausea, Ultrasound scan
Clinical narrative: Abdominal pain, nauseated, bloating feeling full, headache...constant.
Age: 1.08
Sex: F
Vaccine: DTAPHEPBIP, HEPA, HIBV, MMR, PNC, VARCEL
Symptoms: Febrile convulsion, Postictal state, Pyrexia, Tonic clonic movements
Clinical narrative: Simple febrile seizure, generalized tonic-clonic shaking, lasted approximately 2 minutes. Brief post-ictal symptoms. Seen in the ED after and returned to baseline with normal exam. Was febrile in the ED.
Age: 14.0
Sex: F
Vaccine: FLU3, HPV4
Symptoms: Dizziness, Headache
Clinical narrative: Dizziness and headache x4 days.
Age: 12.0
Sex: M
Vaccine: HPV4, HPV4
Symptoms: Headache, Nausea, Oropharyngeal pain, Sleep disorder
Clinical narrative: Headache at night / with disrupted sleep (08/25/14) following vaccine admin. Awoke next AM with sore throat/nausea (08/26/14) parent gave patient TUMS PO.
Age: 12.0
Sex: M
Vaccine: HPV4, HPV4
Symptoms: Headache, Lethargy, Pain
Clinical narrative: Headache at night / with disrupted sleep (08/25/14) following vaccine admin. Awoke next AM with sore throat/nausea (08/26/14) parent gave patient TUMS PO.
Age: 58.0
Sex: F
Vaccine: FLU3, PPV
Symptoms: Injection site erythema, Injection site pruritus, Injection site swelling, Vomiting
Clinical narrative: Patient called back to the pharmacy about 5 hours after vaccine administration to report swelling and redness in most of upper right arm as well as itching. She also reported vomiting. Patient advised to seek medical attention. She went to the ER on 9/8/14 and was told that the needle possibly hit a vein. She stated she is feeling better and improving on follow-up 9/9/14.
Sex: F
Vaccine: HEP
Symptoms: Incorrect storage of drug, No adverse event
Clinical narrative: This spontaneous report was received from the registered nurse refers to an unknown number of patients of unknown age and gender. On an unknown date, the patient was vaccinated with RECOMBIVAX HB (dose, route and lot were not reported). On an unknown date, th patients received improperly stored RECOMBIVAX HB. No adverse symptoms reported. At the time of the report the action taken was not reported. All telephone attempts to obtain follow-up information have been unsuccessful.  Additional information was received from a registered nurse concerning a female patient: Patients birth weight was 8bls 12 oz with 0 siblings. Patient was vaccinated with RECOMBIVAX HB the same day that he was born (18-JUL-2014) at 16:42 PM. Lot number J012520; Exp. Date: 30-JUN-2016. The vaccine storage temp dropped to 0-1 on 18 different episodes between May 14 and July 21st (unspecified year) according to min/max. All recorded temps are within 2-8 degrees. Additional information is not expected since all follow ups requested to complete the case were received.
Sex: U
Vaccine: HPV4
Symptoms: Incorrect storage of drug, No adverse event
Clinical narrative: This spontaneous report was received from a healthcare worker referring to an unknown number of patients that may have been vaccinated with a dose of GARDASIL (dose, route and lot # not reported). The healthcare worker reported that an unknown number of doses of GARDASIL that were exposed to 10 degrees C for 1 hour and 17 minutes then exposed to 8.7 degrees C for 28 minutes may have been administered. No adverse effect reported. This is one of two reports from the same reporter source. Additional information is not expected due to no other information was available at the time of the report.
Age: 2.0
Sex: F
Vaccine: DTAPIPVHIB, MMR, PNC13, VARCEL
Symptoms: Eye swelling, Eyelid oedema
Clinical narrative: Swollen left eye, 5 minutes after vaccines. Mother gave child BENADRYL. Mother called 9/9/14 informing us that her left eye was swollen shut. Appt made for evaluation.
Age: 5.0
Sex: F
Vaccine: DTAPIPV, HEPA, MMR, VARCEL
Symptoms: Injection site erythema, Injection site pruritus, Injection site swelling
Clinical narrative: Pt c/o redness, swelling, and itching at the injections site
Age: 49.0
Sex: F
Vaccine: PPV
Symptoms: Mobility decreased, Pain in extremity
Clinical narrative: This spontaneous report was received from a register nurse, reporting a 49 year old female patient with drug reaction/allergies to CELEXA. The patient's medical history included recent appendectomy. On 03-SEP-2014, the patient was vaccinated with a single dose of PNEUMOVAX 23 lot # K004281, expiration date 22-MAR-2015, intramuscular route. Concomitant therapies included XANAX, bupropion hydrochloride and hydrocodone. The nurse reported the patient developed severe pain in the right arm, from shoulder to elbow, a few hours after administration of PNEUMOVAX 23 on 03-SEP-2014. The nurse added that the severe pain in the right arm makes it difficult for the patient, who recently had an appendectomy, to re-position her self. At the time of the report the outcome was reported as not recovered. No lab diagnostics studies were performed. Severe pain in the right arm, from shoulder to elbow makes it difficult for the patient, who recently had an appendectomy, to re-position her self was considered by reporter to be disability. Patient call to the office for medical attention. This is one of several reports from the same source (MARRS 1409USA003160 and 1409USA002618). Additional information has been requested.
Age: 0.3
Sex: F
Vaccine: DTAPHEPBIP, HIBV, PNC13
Symptoms: Crying, Injection site erythema
Clinical narrative: Mother called approx 3:30 pm, stating child has been crying constantly since vaccines were given right thigh is reddened. Brought baby into clinic approx 4:00 pm. Sl redness noted. Discussed giving TYLENOL and applying cold compress to site.
Sex: U
Vaccine: HPV4
Symptoms: Incorrect storage of drug, No adverse event
Clinical narrative: This spontaneous report as received from a nurse refers to unspecified patients. The patients medical history was not reported. On an unknown date the unspecified patients were vaccinated with doses of GARDASIL that were exposed to a supported temperature excursion on unspecified dates. No adverse experience has been observed or reported. No product quality complaint (PQC) was reported for GARDASIL. Follow up information has been received from a registered nurse. The reporter stated that on 13-AUG-2014 one of the patients was administered with GARDASIL, lot # J006850, expiration date: 31-MAR-2016. This is one of several reporters from the same source. Additional information has been requested.
Sex: U
Vaccine: MMR
Symptoms: Expired drug administered, No adverse event
Clinical narrative: This spontaneous report as received from a physician refers to a patient of unknown age and gender. Concomitant medication, pertinent medical history and drug reaction and allergies were not reported. On 25-AUG-2014, the physician reported that the patient was vaccinated with a dose of M-M-R II, subcutaneous (dose and lot number were not reported), which expired vaccine on 25-JUL-2014 and was inadvertently administered to a patient. No adverse effect was reported. Additional information has been requested.
Age: 71.0
Sex: F
Vaccine: FLU3, PPV
Symptoms: Myalgia, Nausea, Vaccination site pain, Vaccination site paraesthesia
Clinical narrative: Around dinnertime day of vaccination, patient started feeling pain in her arm around site of vaccination sensitive to temp. and touch. Next day pain increased, and pt became nauseous and experienced unbearable myalgia. No treatment necessary, patient recovered in 1-2 days.
Age: 66.0
Sex: F
Vaccine: FLU3, PPV
Symptoms: Pyrexia, Rash, Swelling
Clinical narrative: Swelling accompanying rash, fever 102 degrees F brought down by ALEVE. Advised pt. to apply BENADRYL to the spot (upper left arm) admin. site of PNEUMOVAX shot.
Age: 4.0
Sex: M
Vaccine: MMR, VARCEL
Symptoms: Rash
Clinical narrative: Rash 7 days post vaccine administration, RX with Acyclovir susp. 200 mg/5 ml. 10 ml po q 6 x 7 days.
Age: 68.0
Sex: F
Vaccine: FLU3
Symptoms: Injection site erythema, Injection site pain, Injection site pruritus, Pain
Clinical narrative: Redness, itching, burning distal to injection site - 12 hrs after injection. Achy within 1-2 hrs of vaccine.
Age: 16.0
Sex: F
Vaccine: HEPA
Symptoms: Chills, Headache, Nausea, Pain, Vomiting
Clinical narrative: Headache, Chills, Nausea, Vomiting x 1, Local soreness.
Sex: U
Vaccine: MMR
Symptoms: Autism
Clinical narrative: This spontaneous report as received from a speech pathologist refers to an unspecified amount of children of unknown age and gender. Concomitant medication, pertient medical history, drug reaction and allergies were not reported. On an unknown date, the unspecified amount of children were vaccinated with M-M-R II (lot number, dose and route were not provided). On an unknown date, the reporter was aware of the unspecified amount of children who had autism after receiving the M-M-R II . The outcome of autism was not reported. Additional information is not expected, because the correspondence contact was not provided.
Sex: M
Vaccine: HEP
Symptoms: Incorrect storage of drug, No adverse event
Clinical narrative: This spontaneous report was received from the registered nurse refers to an unknown number of patients of unknown age and gender. On an unknown date, the patient was vaccinated with RECOMBIVAX HB (dose, route and lot were not reported). On an unknown date, the patients received improperly stored   RECOMBIVAX HB. No adverse symptoms reported. At the time of the report the action was not reported. All telephone attempts to obtain follow-up information have been unsuccessful.  Additional information was received from a registered nurse concerning a 1 day male patient. Patient's birth weight was 8 lb 6 oz with 0 siblings. Patient was vaccinated with RECOMBIVAX HB the same day that he was born (27-MAY-2014) at 10:47 AM. Lot number J012520; Exp. Date: 30-JAN-2016.  The vaccine storage temp dropped to 0-1 degrees on 18 different episodes between May 14th and July 21st (unspecified year) according to min/max. All recorded temps are within 2-8 degrees. Additional information is not expected since all follow ups requested to complete the case were received.
Sex: U
Vaccine: HEP
Symptoms: Incorrect storage of drug, No adverse event
Clinical narrative: This spontaneous report was received from the registered nurse refers to an unknown number of patients of unknown age and gender. On an unknown date, the patient was vaccinated with RECOMBIVAX HB (dose, route and lot were not reported). On an unknown date, the patients received improperly stored   RECOMBIVAX HB. No adverse symptoms reported. At the time of the report the action was not reported. All telephone attempts to obtain follow-up information have been unsuccessful.  Additional information was received from a registered nurse concerning a 1 day male patient. Patient's birth weight was 6 lb 7 oz with 0 siblings. Patient was vaccinated with RECOMBIVAX HB the same day that he was born (19-MAY-2014) at 08:50 AM. Lot number J012520; Exp. Date: 30-JAN-2016.  The vaccine storage temp dropped to 0-1 degrees on 18 different episodes between May 14th and July 21st (unspecified year) according to min/max. All recorded temps are within 2-8 degrees. Additional information is not expected since all follow ups requested to complete the case were received.
Sex: M
Vaccine: HEP
Symptoms: Incorrect storage of drug, No adverse event
Clinical narrative: This spontaneous report was received from the registered nurse refers to an unknown number of patients of unknown age and gender. On an unknown date, the patient was vaccinated with RECOMBIVAX HB (dose, route and lot were not reported). On an unknown date, the patients received improperly stored   RECOMBIVAX HB. No adverse symptoms reported. At the time of the report the action was not reported. All telephone attempts to obtain follow-up information have been unsuccessful.  Additional information was received from a registered nurse concerning a 1 day male patient. Patient's birth weight was 5 lb 5 oz with 0 siblings. Patient was vaccinated with RECOMBIVAX HB the same day that he was born (27-MAY-2014) at 10:47 AM. Lot number J012520; Exp. Date: 30-JAN-2016.  The vaccine storage temp dropped to 0-1 degrees on 18 different episodes between May 14th and July 21st (unspecified year) according to min/max. All recorded temps are within 2-8 degrees. Additional information is not expected since all follow ups requested to complete the case were received.
Sex: F
Vaccine: PPV
Symptoms: Injection site cellulitis
Clinical narrative: This spontaneous report as received from a physician via a field representative refers to a female patient of unknown age. No demographics were provided for the patients, other than the gender. The pertinent medical history and drug reactions/allergies were unspecified by the reporter. On an unknown date, patient was vaccinated with PNEUMOVAX23 (dose, route and lot number not reported). Concomitant medication at the time of event was unspecified by reporter. On an unknown date, patient experienced cellulitis at the injection site, after receiving PNEUMOVAX23. The patient was treated with antibiotics (unspecified name, dose/frequency and manufacturer). The event cellulitis was recovered on an unspecified date. The patient sought medical attention, and made an office visit on an unspecified date. No product quality complaint (PQC) was reported. The causality was snot reported. This is one of the two cases reported by the same reporter. Additional information has been requested.
Sex: F
Vaccine: PPV
Symptoms: Injection site cellulitis
Clinical narrative: This spontaneous report as received from a physician via a field representative refers to a female patient of unknown age. No demographics were provided for the patients, other than the gender. The pertinent medical history and drug reactions/allergies were unspecified by the reporter. On an unknown date, patient was vaccinated with PNEUMOVAX23 (dose, route and lot number not reported). Concomitant medication at the time of event was unspecified by reporter. On an unknown date, patient experienced cellulitis at the injection site, after receiving PNEUMOVAX23. The patient was treated with antibiotics (unspecified name, dose/frequency and manufacturer). The event cellulitis was recovered on an unspecified date. The patient sought medical attention, and made an office visit on an unspecified date. No product quality complaint  (PQC) was reported. The causality was not reported.  This is one of the two cases reported by the same reporter. Additional information has been requested.
Sex: M
Vaccine: HEP
Symptoms: Incorrect storage of drug, No adverse event
Clinical narrative: This spontaneous report was received from the registered nurse refers to an unknown number of patients of unknown age and gender. On an unknown date, the patient was vaccinated with RECOMBIVAX HB (dose, route and lot were not reported). On an unknown date, the patients received improperly stored   RECOMBIVAX HB. No adverse symptoms reported. At the time of the report the action was not reported. All telephone attempts to obtain follow-up information have been unsuccessful.  Additional information was received from a registered nurse concerning a 1 day male patient. Patient's birth weight was 7 lb 15 oz with 0 siblings. Patient was vaccinated with RECOMBIVAX HB the same day that he was born (16-MAY-2014) at 14:00 PM. Lot number J012520; Exp. Date: 30-JAN-2016.  The vaccine storage temp dropped to 0-1 degrees on 18 different episodes between May 14th and July 21st (unspecified year) according to min/max. All recorded temps are within 2-8 degrees. Additional information is not expected since all follow ups requested to complete the case were received.
Sex: U
Vaccine: PPV
Symptoms: Expired drug administered, No adverse event
Clinical narrative: This spontaneous report as received from a pharmacist refers to a patient of unknown age. On 08-SEP-2014 the patient was vaccinated with PNEUMOVAX23 INJ (route, dosage, dose number and lot number unknown; expiration reported as 22-AUG-2014). The pharmacist reported the patient inadvertently received an expired dose of PNEUMOVAX23. No adverse effects reported. Additional information is not expected because there was no permission to contact the physician.
Sex: F
Vaccine: HEP
Symptoms: Incorrect storage of drug, No adverse event
Clinical narrative: This spontaneous report was received from the registered nurse refers to an unknown number of patients of unknown age and gender. On an unknown date, the patient was vaccinated with RECOMBIVAX HB (dose, route and lot were not reported). On an unknown date, the patients received improperly stored   RECOMBIVAX HB. No adverse symptoms reported. At the time of the report the action was not reported. All telephone attempts to obtain follow-up information have been unsuccessful.  Additional information was received from a registered nurse concerning a 1 day male patient. Patient's birth weight was 6 lb 13 oz with 1 siblings. Patient was vaccinated with RECOMBIVAX HB the same day that he was born (29-MAY-2014) at 19:05 PM. Lot number J012520; Exp. Date: 30-JAN-2016.  The vaccine storage temp dropped to 0-1 degrees on 18 different episodes between May 14th and July 21st (unspecified year) according to min/max. All recorded temps are within 2-8 degrees. Additional information is not expected since all follow ups requested to complete the case were received.
Sex: U
Vaccine: HEP
Symptoms: Incorrect storage of drug, No adverse event
Clinical narrative: This spontaneous report was received from the registered nurse refers to an unknown number of patients of unknown age and gender. On an unknown date, the patient was vaccinated with RECOMBIVAX HB (dose, route and lot were not reported). On an unknown date, the patients received improperly stored   RECOMBIVAX HB. No adverse symptoms reported. At the time of the report the action was not reported. All telephone attempts to obtain follow-up information have been unsuccessful.  Additional information was received from a registered nurse concerning a 1 day male patient. Patient's birth weight was 7 lb 15 oz with 0 siblings. Patient was vaccinated with RECOMBIVAX HB the same day that he was born (22-MAY-2014) at 14:43 PM. Lot number J012520; Exp. Date: 30-JAN-2016.  The vaccine storage temp dropped to 0-1 degrees on 18 different episodes between May 14th and July 21st (unspecified year) according to min/max. All recorded temps are within 2-8 degrees. Additional information is not expected since all follow ups requested to complete the case were received.
Age: 10.0
Sex: M
Vaccine: FLU3
Symptoms: Dyspnoea, Pharyngeal oedema, Urticaria
Clinical narrative: Hives, throat swelling, trouble breathing.
Age: 1.6
Sex: F
Vaccine: DTAPIPV, PNC13
Symptoms: Inappropriate schedule of drug administration
Clinical narrative: None at this time.
Age: 0.34
Sex: M
Vaccine: DTAPIPVHIB, PNC13, RV5
Symptoms: Adenovirus test, Diarrhoea, Haematochezia, Pyrexia, Rotavirus test negative
Clinical narrative: Fever, diarrhea, bloody stools x 1 wk.
Age: 16.0
Sex: M
Vaccine: HEPA, HPV4, MNQ, VARCEL
Symptoms: Hypoaesthesia, Injection site pain, Injection site swelling, Pyrexia, Vaccination site papule
Clinical narrative: Pain, swelling Rt upper arm, occasional numbness - can move arm. Few papules at vaccine site. Low grade temp 100.1 oral.
Age: 77.0
Sex: F
Vaccine: FLU3
Symptoms: Arthralgia, Body temperature increased, Chills, Fatigue, Injection site pain
Clinical narrative: Injection site pain and itching and swelling - starting within one hour of shot - sore elbow, arm (knots on legs, started 9-9-14). Tired, chills, temp of 102.7 8pm on 9-9-14. Has been on TYLENOL for pain.
Age: 77.0
Sex: F
Vaccine: FLU3
Symptoms: Injection site pruritus, Injection site swelling, Nodule, Pain in extremity
Clinical narrative: Injection site pain and itching and swelling - starting within one hour of shot - sore elbow, arm (knots on legs, started 9-9-14). Tired, chills, temp of 102.7 8pm on 9-9-14. Has been on TYLENOL for pain.
Age: 51.0
Sex: F
Vaccine: PPV, TDAP
Symptoms: Vaccination complication
Clinical narrative: Seen 9/2/14 s/p vaccine given. Pt prescribed ibuprofen, BENADRYL, Increased BACTRIM. DX: vaccine reaction.
Age: 80.0
Sex: F
Vaccine: FLU3
Symptoms: Local swelling, Pyrexia, Vomiting
Clinical narrative: Patient experience severe arm swelling, fever, and vomiting the night after administration.
Age: 14.0
Sex: F
Vaccine: HPV4
Symptoms: Crying, Personality change
Clinical narrative: This spontaneous report as received from a nurse practitioner via a company representative refers to a 14 year old female patient. On an unknown date in 2012 (reported as two years ago) the patient was vaccinated with the first dose of GARDASIL (dose, route, lot#, expiration date and frequency were unknown). Later on that day the patient began to cry uncontrollably and experienced personality changes where she became worried about her animals. The patient did not finish the GARDASIL series due to these reactions. The patient did not seek for medical attention. The outcome of the events was unknown. Additional information has been requested.
Age: 66.0
Sex: F
Vaccine: FLU3, VARZOS
Symptoms: Lip swelling, Pharyngeal oedema, Swelling face
Clinical narrative: Patient reported eating dinner (at restaurant), went home and began noticing swelling in lips, nose, throat and face. Her daughter is a nurse and administered BENADRYL. Patient appeared to be recovered today.
Age: 30.0
Sex: M
Vaccine: TDAP
Symptoms: Generalised erythema, Injection site urticaria, Rash generalised, Urticaria, Vaccination site rash
Clinical narrative: 8-25-14 Adacel shot given, 8-26-14 rashes/redness on body and feet/legs. Rashes/hives on left arm and hands where vaccine was administered. 9-2-14 grand mother called pharmacy to report incident/called patient. 9-5-14 pt. went to ER and was prescribed Prednisone 20g and Benadryl 25g. 9-8-14 Follow-up call. Pt rashes/hives greatly diminished.
Age: 0.46
Sex: F
Vaccine: IPV, PNC13
Symptoms: Inappropriate schedule of drug administration, No adverse event
Clinical narrative: Pt received first dose of Rotavirus at age 5 months. No adverse reaction anticipated, none occurred.
Age: 0.69
Sex: M
Vaccine: IPV, PNC13, RV5
Symptoms: Drug administered to patient of inappropriate age, No adverse event
Clinical narrative: First dose of rotavirus vaccine given at age 8 mos. No adverse reaction occurred, none anticipated.
Age: 0.58
Sex: M
Vaccine: DTAP, HIBV, RV5
Symptoms: Inappropriate schedule of drug administration, No adverse event
Clinical narrative: Pt received first dose of ROTATEQ at age 7 mos. - No adverse reactions anticipated/occurred.
Age: 0.69
Sex: M
Vaccine: HEP, RV5
Symptoms: Inappropriate schedule of drug administration, No adverse event
Clinical narrative: Pt received ROTATEQ vaccine - dose #1 at age 8 mos. - No adverse reactions anticipated or occurred.
Age: 0.69
Sex: F
Vaccine: HEP, RV5
Symptoms: Inappropriate schedule of drug administration, No adverse event
Clinical narrative: ROTATEQ vaccine dose #1 given at age 8 mos. No reactions occurred/anticipated.
Sex: M
Vaccine: HEP
Symptoms: Incorrect storage of drug, No adverse event
Clinical narrative: This spontaneous report was received from the registered nurse refers to an unknown number of patients of unknown age and gender. On an unknown date, the patient was vaccinated with RECOMBIVAX HB (dose, route and lot were not reported). On an unknown date, the patients received improperly stored   RECOMBIVAX HB. No adverse symptoms reported. At the time of the report the action was not reported. All telephone attempts to obtain follow-up information have been unsuccessful.  Additional information was received from a registered nurse concerning a 1 day male patient. Patient's birth weight was 8 lb 13oz with 0 siblings. Patient was vaccinated with RECOMBIVAX HB the same day that he was born (02-JUN-2014) at 22:46 PM. Lot number J012520; Exp. Date: 30-JAN-2016.  The vaccine storage temp dropped to 0-1 degrees on 18 different episodes between May 14th and July 21st (unspecified year) according to min/max. All recorded temps are within 2-8 degrees. Additional information is not expected since all follow ups requested to complete the case were received.
Sex: M
Vaccine: HEP
Symptoms: Incorrect storage of drug, No adverse event
Clinical narrative: This spontaneous report was received from the registered nurse refers to an unknown number of patients of unknown age and gender. On an unknown date, the patient was vaccinated with RECOMBIVAX HB (dose, route and lot were not reported). On an unknown date, the patients received improperly stored   RECOMBIVAX HB. No adverse symptoms reported. At the time of the report the action was not reported. All telephone attempts to obtain follow-up information have been unsuccessful.  Additional information was received from a registered nurse concerning a neonate male patient. Patient's birth weight was 8 lb 3 oz with 2 siblings. Patient was vaccinated with RECOMBIVAX HB the same day that he was born (04-JUN-2014) at 14:22 PM. Lot number J012520; Exp. Date: 30-JAN-2016.  The vaccine storage temp dropped to 0-1 degrees on 18 different episodes between May 14th and July 21st (unspecified year) according to min/max. All recorded temps are within 2-8 degrees. Additional information is not expected since all follow ups requested to complete the case were received.
Sex: U
Vaccine: VARZOS
Symptoms: Rash vesicular
Clinical narrative: This spontaneous report as received from a pharmacist refers to a patient of unknown age and unknown gender. Pertinent medical history, drug reactions or allergies were not reported. On an unknown date (reported as a long time ago) the patient was vaccinated with ZOSTAVAX vial, 19400 PFU (dose number, route, anatomical location, lot number and expiration date were unspecified). No concomitant therapies were reported. On an unknown date, four days after administration, the patient experienced varicella like rash. The patient did not seek medical attention. The outcome of varicella like rash was unknown.  The relatedness between ZOSTAVAX and the event was not reported.  Additional information is not expected because reporter refused additional contact.
Sex: F
Vaccine: HPV4
Symptoms: Syncope
Clinical narrative: This spontaneous report as received from a registered nurse refers to a female patient of unknown age. On an unknown date the patient was vaccinated with GARDASIL (dose, route and lot# not reported). It was reported that on an unknown date the patient fainted after receiving GARDASIL. The outcome of fainted was unknown. It was unknown if the patient sought medical attention. This is one of the reports from the same reporter. Additional information has been requested.
Sex: U
Vaccine: HPV4
Symptoms: Incorrect storage of drug, No adverse event
Clinical narrative: This spontaneous report as received from a nurse refers to an unspecified number of patients of unknown demographics. No concurrent conditions or medical history were provided. On 29-AUG-2014, an unspecified number of patients had received improperly stored doses of GARDASIL injection (dose, frequency, route and lot # unknown). No symptoms reported. This is one of several reports from the same source. Additional information has been requested.
Sex: U
Vaccine: PPV
Symptoms: Incorrect storage of drug, No adverse event
Clinical narrative: This spontaneous report as received from a nurse refers to an unspecified number of patients of unknown demographics. No concurrent conditions or medical history were provided. On 29-AUG-2014, an unspecified number of patients had received improperly stored doses of PNEUMOVAX23 (dose, frequency, route and lot # unknown). No symptoms reported. This is one of several reports from the same source. Additional information has been requested.
Age: 68.0
Sex: F
Vaccine: VARZOS
Symptoms: Herpes zoster, Pain
Clinical narrative: This spontaneous report was received from an office manager via a company representative refers to a 68 year old female patient (also reported as patient's demographics were unknown). Patient's medical history and drug reactions or allergies were not reported. On 14-MAY-2014 the patient was vaccinated with ZOSTAVAX (strength, site of administration and lot number were not reported) dose 1 (reported as 1 single shot), subcutaneous. Concomitant medications were not reported. On 28-AUG-2014 the patient experienced pain after receiving ZOSTAVAX. It was reported that the patient went to a walk in clinic presenting with pain. 6 days later on 03-SEP-2014, the physician diagnosed the patient with shingles. The patient was treated with FAMVIR for the events. The patient had sought medical attention by visiting the clinic and consulting the physician. There was no product quality complaint (PQC) involved. The outcome of shingles and pain after receiving ZOSTAVAX was reported as recovering/resolving. The causality of the events was unknown. Additional information has been requested.
Sex: U
Vaccine: RV5
Symptoms: Incorrect storage of drug, No adverse event
Clinical narrative: This spontaneous report as received from a nurse refers to an unspecified number of patients of unknown demographics. No concurrent conditions or medical history were provided. On 29-AUG-2014, an unspecified number of patients had received improperly stored doses of ROTATEQ (dose, frequency and lot # unknown) orally. No symptoms reported. This is one of several reports from the same source. Additional information has been requested.
Sex: U
Vaccine: HPV4
Symptoms: Inappropriate schedule of drug administration
Clinical narrative: This spontaneous report as received from a nurse refers to a patient of unknown age. On an unknown date the patient was vaccinated with the second dose of GARDASIL (dose, route and lot# not reported) late (start date, route and lot # of first dose were unknown). Additional information is not expected. There is no contact information for the nurse.