chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 61.0
Sex: M
Vaccine: VARZOS
Symptoms: Injection site pain, Nerve injury
Clinical narrative: ON 9/16/2019, PT RETURNED TO PHARMACY AND TOLD US THAT ON THE DAY HE RECEIVED THE VACCINE HE HAD TO GO THE EMERGENCY ROOM DUE TO SEVERE PAIN IN LEFT DELTOID, AND SAID THAT HE THOUGHT HE WAS HAVING A HEART ATTACK, AFTER BEING ADMITTED ER DOCTOR TOLF HIM THAT WHAT HE WAS EXPERIENCING WAS A RESULT OF THE VACCINE HITTING A NERVE.
Age: 56.0
Sex: F
Vaccine: FLUC4
Symptoms: Injection site irritation, Injection site pain
Clinical narrative: extreme irritation and pain at injection site (abnormal)
Age: 24.0
Sex: M
Vaccine: HEPA
Symptoms: Feeling hot, Presyncope, Tinnitus, Vision blurred
Clinical narrative: patient started to feel warm, ringing in ear, blurred visions, signs of syncope with no true fainting, Patient monitored given ice pack, fan and water until cooled down. pt did not need to go to emergency room or call 911
Age: 84.0
Sex: M
Vaccine: FLU3
Symptoms: Injection site bruising
Clinical narrative: Brusing at site of injection
Age: 76.0
Sex: F
Vaccine: FLU3, PPV
Symptoms: Injection site erythema, Injection site warmth
Clinical narrative: redness, warmth at site of injection.  Used a warm compress and bendaryl.
Age: 12.0
Sex: M
Vaccine: FLU4
Symptoms: Syncope, Unresponsive to stimuli
Clinical narrative: Fainting reaction: occurred 1-2 minutes after vaccine administration. Non-responsive for a few seconds, then brief response. Cold paper towels were applied to face and patient responded to questions. Patient drank some bottled water. Time from initial reaction  to recovery was approximately 20 minutes.
Age: 60.0
Sex: M
Vaccine: VARZOS
Symptoms: Heart rate decreased, Urticaria
Clinical narrative: Patient call me today at 5:45pm and stated that today after eating lunch he experienced hives all over his bodyand his watch showed his heart rate to be low. He stated that it wasn't his lunch because he eats the same thing each day: a salad and sardines.  At the time of the call he stated his heart rate returned to normal but he still had hives on his arms.  I recommended that he go to urgent care if the reaction worsen or he felt hypotensive, shortness of breath, etc. He agreed. I also told him the PIC who administered his IMZ would contact his PCP in the morning and then follow up with the patient. I also recommended him to call back tonight and consult with me if anything worsened.
Age: 64.0
Sex: F
Vaccine: VARZOS
Symptoms: Myalgia, Nausea
Clinical narrative: Extreme muscle pain, nausea,
Age: 61.0
Sex: F
Vaccine: FLUC4, PPV
Symptoms: Erythema, Pyrexia, Tenderness
Clinical narrative: Experienced fever and redness and tenderness in arm starting 72 hours after receiving vaccinations
Age: 78.0
Sex: F
Vaccine: VARZOS
Symptoms: Dizziness, Immediate post-injection reaction, Laboratory test normal, Musculoskeletal pain, Pain in extremity
Clinical narrative: Patient received her first Shingrix vaccine on 9/16/19 at about 230pm.  Immediately after administration (after ban aid application) the patient stated she felt dizzy.  She remained seated and was given water and continued to be observed by the RPH for about 10-15 minutes before the patient told the RPH she was feeling better a able to walk to the front of the pharmacy to pay and then drive home.    The next morning  (9/17/19) the patient called the pharmacy stating that about 2 hours after the vaccine, at home, she started experiencing severe pain in her left arm and shoulder.  The pain had her screaming, becoming short of breath and lead to uncontrollable shaking of her arm and head.  She was taken to the local ED where she was given 2 doses of pain medication.  She had many tests that ruled out a seizure, but she did have multiple x-rays that the MD ruled may have shown that the vaccine was administered too high in the arm.   The patient then discharged from the ED at 930pm on 9/16/19.   During her call to the pharmacy at 1030am on 9/17/19 she was still had a lot of pain in her arm and shoulder and was awaiting her spouse to return from the pharmacy with her pain meds.  She stated that the ED MD attributed her SOB and shaking all to the pain she had been feeling.  Her plan was to rest.  Her chart was documented with the reaction and it was advised that for now, she does not plan to receive the 2nd dose of the Shingirx vaccine.
Age: 78.0
Sex: F
Vaccine: VARZOS
Symptoms: Screaming, Tremor, X-ray
Clinical narrative: Patient received her first Shingrix vaccine on 9/16/19 at about 230pm.  Immediately after administration (after ban aid application) the patient stated she felt dizzy.  She remained seated and was given water and continued to be observed by the RPH for about 10-15 minutes before the patient told the RPH she was feeling better a able to walk to the front of the pharmacy to pay and then drive home.    The next morning  (9/17/19) the patient called the pharmacy stating that about 2 hours after the vaccine, at home, she started experiencing severe pain in her left arm and shoulder.  The pain had her screaming, becoming short of breath and lead to uncontrollable shaking of her arm and head.  She was taken to the local ED where she was given 2 doses of pain medication.  She had many tests that ruled out a seizure, but she did have multiple x-rays that the MD ruled may have shown that the vaccine was administered too high in the arm.   The patient then discharged from the ED at 930pm on 9/16/19.   During her call to the pharmacy at 1030am on 9/17/19 she was still had a lot of pain in her arm and shoulder and was awaiting her spouse to return from the pharmacy with her pain meds.  She stated that the ED MD attributed her SOB and shaking all to the pain she had been feeling.  Her plan was to rest.  Her chart was documented with the reaction and it was advised that for now, she does not plan to receive the 2nd dose of the Shingirx vaccine.
Age: 87.0
Sex: M
Vaccine: VARZOS
Symptoms: Pain in extremity
Clinical narrative: Patient stated that his arm was sore on the day of the vaccine and for two weeks after. He denies needing medical care or any other adverse reaction. He said he had the same reaction after the first dose, which was already reported.
Age: 61.0
Sex: F
Vaccine: VARZOS
Symptoms: Rash, Swelling
Clinical narrative: swollen neck, severe rash on her legs since Thursday. Tried over the counter Benadryl, cortisone 10. Symptoms haven't resolved till Tuesday 09/17/2019
Age: 83.0
Sex: F
Vaccine: VARZOS
Symptoms: Inappropriate schedule of product administration
Clinical narrative: Patient received this shot one month too early.  She did not mention she had any side effects from this
Age: 63.0
Sex: F
Vaccine: VARZOS
Symptoms: Herpes zoster
Clinical narrative: Patient developed Shingles- diagnosed by nurse practioner at the little clinic. Patient believed it may have been from the vaccine.
Age: 36.0
Sex: F
Vaccine: UNK
Symptoms: Pain, Pyrexia
Clinical narrative: Fever 103.1 approximately 12 hours after administration  Body aches and pain (moderate)
Age: 8.0
Sex: M
Vaccine: MMR
Symptoms: Blood test, Glomerulonephritis minimal lesion, Nephrotic syndrome, Oedema, Ultrasound scan
Clinical narrative: My son developed edema that was diagnosed as Nephrotic Syndrome Minimal Change Disease. He was hospitalized 9/3/19. The first NP who saw him said ?this is a vaccine reaction?. He was transferred to hospital and put under the care of a Pediatric Nephrologist. He said the disease manifested ?2-4m? ago and it is ?idiopathic ? so we cannot pin point to the MMR date. But no virus happened and he said it?s viral triggered Or vaccine.
Age: 8.0
Sex: M
Vaccine: MMR
Symptoms: X-ray
Clinical narrative: My son developed edema that was diagnosed as Nephrotic Syndrome Minimal Change Disease. He was hospitalized 9/3/19. The first NP who saw him said ?this is a vaccine reaction?. He was transferred to hospital and put under the care of a Pediatric Nephrologist. He said the disease manifested ?2-4m? ago and it is ?idiopathic ? so we cannot pin point to the MMR date. But no virus happened and he said it?s viral triggered Or vaccine.
Age: 20.0
Sex: F
Vaccine: FLU4, MNQ
Symptoms: Syncope
Clinical narrative: AFTER ADMINISTERING BOTH SHOTS  PATIENT SAID TO HER MOTHER SHE WANTED TO GO EAT.. PATIENTS MOTHER WAS ASKING QUESTIONS TO PHARMACIST  EVERYONE WAS STANDING AND DURING THAT TIME PATIENT FAINTED.. SHE DID NOT LOSE COMPLETE CONSCIOUSNESS  HER EYES WERE OPEN . MOTHER AND RPH TOOK PATIENT TO BENCH WHERE SHE WAS GIVEN WATER AND CANDY BAR. SHE SEEMED TO BE BECOMING MORE ALERT. MOM DID STATE PATIENT HAS FAINTED WHEN NERVOUS ETC AND MAYBE DID NOT EAT THE WHOLE DAY. . PATIENT DID NOT WANT US TO CALL DR OR ANY MEDICAL ASSISTANCE. AND AFTER RESTING FOR 15 TO 20 MINS  SHE LEFT WITH MOM. DID CALL PATIENT 9/17/19 LEFT MESSAGE BUT NO REPLY BACK FORM PATIENT YET,
Age: 44.0
Sex: F
Vaccine: FLU4, TDAP
Symptoms: Hypoaesthesia, Injected limb mobility decreased, Loss of personal independence in daily activities, Pain in extremity, Paraesthesia
Clinical narrative: PATIENT IS STATING THE DAY SHE RECEIVED THE VACCINE SHE FELT PAIN IN HER RIGHT ARM AND IT KEPT GETTING WORSE WITH SOME FEELING OF NUMBNESS AND TINGLING AND COULD BARELY MOVE HER ARM. WENT TO HOSPITAL AND RECVIED A PAIN MEDICATION AND WAS ADVISED TO PUT COLD COMPRESSES THEN WENT TO AN ORTHOPEDIC WHICH GAVE HER A STEROID SHOT ON 9/10/2019  AND PATIENT IS STATING SHE IS A LITTLE BIT BETTER BUT STILL IN PAIN WHICH IS LIMITING HER FROM PERFORMING A LOT OF ACTIVITIES
Age: 70.0
Sex: F
Vaccine: FLU3
Symptoms: Erythema, Injection site bruising, Skin warm
Clinical narrative: PATIENT CAME IN ON MONDAY TO SHOW ME HER ARM. IT HAD REDNESS TWO TO THREE INCHES LOWER THAN THE INJECTION SITE. THERE WAS A BRUISE ON THE INJECTION SITE AND REDNESS LOWER. THE RED AREA WAS WARM TO THE TOUCH. MYSELF AND ANOTHER PHARMACIST LOOKED AT HER ARM ON TUESDAY AFTER TELLING HER TO TAKE BENADRYL AND APPLY ICE OR COLD WASH CLOTH TO THE AREA. IT HAD IMPROVED SINCE THE DAY BEFORE.
Sex: M
Vaccine: FLU4, TDAP
Symptoms: Extra dose administered, Malaise
Clinical narrative: Pt respresently called to say pt felt sick and having hard time getting out of bed. Was told to call MD if pt Sx were severe. MD then called And stated they administered Flu and Boostrix earlier that day. MD stated the were working with pt and to fill out VAERS. Pt dosed twice on Flu + TDP in same day.
Age: 66.0
Sex: F
Vaccine: FLUA3, PPV
Symptoms: Back pain, Dizziness, Hypoaesthesia, Immediate post-injection reaction
Clinical narrative: Pt immediately complained of dizziness. She then felt back pain and numbness in her hands. I called 911 and EMS arrived. They checked her vitals and stayed with her for about 30 minutes. She then began to feel better. Her daughter-in-law came to pick her up. She instructed to follow up with healthcare provider.
Age: 74.0
Sex: F
Vaccine: VARZOS
Symptoms: Headache, Injection site swelling, Injection site warmth, Nausea
Clinical narrative: Patient reported swelling and warmth the next day after receiving vaccine. Patient applied cool compresses to the site, and swelling and warmth have decreased. She is also still experiencing headache and nausea. I contacted her physician and was informed to have patient come to office if symptoms worsen.
Age: 16.0
Sex: M
Vaccine: HPV9
Symptoms: Abdominal pain lower, Computerised tomogram abdomen, Computerised tomogram pelvis, Full blood count, Urine analysis
Clinical narrative: Right lower quadrant pain - started abruptly
Age: 7.0
Sex: M
Vaccine: TD
Symptoms: Injection site erythema, Injection site induration, Injection site warmth
Clinical narrative: local redness, warmth + induration @ (L) deltoid
Age: 10.0
Sex: F
Vaccine: FLU4, TDAP
Symptoms: Lipids, Urticaria
Clinical narrative: Patient has received DTAP & yearly Flu vaccine w/o adverse reaction in the past. 5 min after administration had hives on face without angioedema/wheezing/respiratory distress/stomach pain. Diphenhydramine administered and observed for 25 minutes
Age: 12.0
Sex: M
Vaccine: FLU4, HPV9, MNQ, TDAP
Symptoms: Nausea, Pallor, Unresponsive to stimuli
Clinical narrative: Pt was given 4 vaccinations, Pt was seated after all were given pt laid his head down on his arm, This RN shook pt and said his name and he did not respond for 10 seconds. He responded after 10 seconds and was pale + Nauseous. Squad was called to evaluate. Left Health Dept with mother not squad. Was not taken to hospital.
Age: 5.0
Sex: U
Vaccine: DTAPHEPBIP, HEPA, MMR, VARCEL
Symptoms: Crying, Deafness bilateral, Diarrhoea, Ear infection, Nasopharyngitis
Clinical narrative: 9/13/19 onset sleeplessness, waking up crying, cold symptoms, diarrhea, fever 9/17/19 called public health for advice, advised to seek MD care, MD treated child for ear infection with antibiotics 9/18/19 bilateral hearing loss persists, mom states her concern VIS states MMR can result in deafness
Age: 5.0
Sex: U
Vaccine: DTAPHEPBIP, HEPA, MMR, VARCEL
Symptoms: Pyrexia, Somnolence
Clinical narrative: 9/13/19 onset sleeplessness, waking up crying, cold symptoms, diarrhea, fever 9/17/19 called public health for advice, advised to seek MD care, MD treated child for ear infection with antibiotics 9/18/19 bilateral hearing loss persists, mom states her concern VIS states MMR can result in deafness
Age: 24.0
Sex: F
Vaccine: HPV9
Symptoms: Headache, Oropharyngeal pain, Pyrexia
Clinical narrative: sore throat, headache, to fever for 4 days.
Age: 63.0
Sex: F
Vaccine: VARZOS
Symptoms: Fatigue, Herpes zoster, Injection site reaction, Pyrexia, Rash erythematous
Clinical narrative: pt received 1st dose of Shingrix on Sept 8, 2019, developed shingle (one spot near shoulder on her back) on Sept. 9, 2019. also low grade fever, fatigue, red dots around injection site. Currently taking Valtrex for the singles. Pt had a shingle episode in July 2019, recovered, dr. sent her to get shingle shot.
Sex: M
Vaccine: VARZOS, VARZOS
Symptoms: Neuralgia
Clinical narrative: peripheral nerve pain which included his hands, feet, back, buttocks; This case was reported by a consumer via call center representative and described the occurrence of nerve pain in a male patient who received Herpes zoster (Shingrix) for prophylaxis.   On 26th July 2019, the patient received the 1st dose of Shingrix. On 22nd August 2019, 27 days after receiving Shingrix, the patient experienced nerve pain. The patient was treated with gabapentin. On an unknown date, the outcome of the nerve pain was unknown.   It was unknown if the reporter considered the nerve pain to be related to Shingrix.  Additional details were provided as follows: The age at vaccination was not reported. The patient developed peripheral nerve pain which included his hands, feet, back, buttocks. The patient did not provide any additional information. The patient consented to follow up.
Sex: U
Vaccine: VARCEL, VARCEL
Symptoms: No adverse event, Product storage error
Clinical narrative: No adverse effect reported; On 27-AUG-2019, one patient received an improperly stored VARlVAX; This spontaneous report was received from a nurse and concerns to a 4 year old patient of unknown gender. The patient's historical condition, and drug reactions or allergies were not reported. Concomitant therapies included sterile diluent(STERILE DILUENT).     On 05-SEP-2019,  the patient was vaccinated with an improperly stored dose of varicella virus vaccine live (oka/merck)(VARIVAX) (dosage schedule, route, anatomical location were not reported)(it can not be determined with which lot number was vaccinated the patient (R006221 and expiration date 29-FEB-2020 or R029517 and expiration date 14-OCT-2020)) for prophylaxis. The administered dose of the vaccine experienced a temperature excursion of -14 degrees Celsius to -10 degrees Celsius for 8 hours as recorded by a data logger. No previous temperature excursion was reported. There was no adverse effect reported.; Sender's Comments:  US-009507513-1909USA002960: US-009507513-1909USA006328: US-009507513-1909USA006331: US-009507513-1909USA006332: US-009507513-1909USA006333: US-009507513-1909USA006330: US-009507513-1909USA006334: US-009507513-1909USA006341:
Sex: U
Vaccine: VARCEL, VARCEL
Symptoms: No adverse event, Product storage error
Clinical narrative: No adverse effect reported; one patient received an improperly stored VARlVAX; This spontaneous report was received from a nurse and concerns to a 4 year old patient of unknown gender. The patient's historical condition, and drug reactions or allergies were not reported. Concomitant therapies included sterile diluent.   On 28-AUG-2019,  the patient was vaccinated with an improperly stored dose of varicella virus vaccine live (oka/merck)(VARIVAX) (dosage schedule, route, anatomical location were not reported)(it can not be determined with which lot number was vaccinated the patient (R006221 and expiration date 29-FEB-2020 or R029517 and expiration date 14-OCT-2020)) for prophylaxis. The administered dose of the vaccine experienced a temperature excursion of -14 degrees Celsius to -10 degrees Celsius for 8 hours as recorded by a data logger. No previous temperature excursion was reported. There was no adverse effect reported.; Sender's Comments:  US-009507513-1909USA002960: US-009507513-1909USA006329: US-009507513-1909USA006331: US-009507513-1909USA006332: US-009507513-1909USA006333: US-009507513-1909USA006330: US-009507513-1909USA006334: US-009507513-1909USA006341:
Sex: U
Vaccine: MMRV, MMRV
Symptoms: No adverse event, Product storage error
Clinical narrative: No adverse effect reported; one patient received an improperly stored VARlVAX; This spontaneous report was received from a nurse and concerns to a 4-year-old patient of unknown gender. The patient's historical condition, and drug reactions or allergies were not reported. Concomitant therapies included sterile diluent.     On 27-AUG-2019, the patient was vaccinated with an improperly stored dose of measles, mumps, rubella and varicella (Oka-Merck) Virus Vaccine Live (PROQUAD) (dosage schedule, route, anatomical location were not reported) (it cannot be determined with which lot number was vaccinated the patient (R026722 and expiration date 17-MAR-2020 or R023499 and expiration date 13-FEB-2020)) for prophylaxis. The administered dose of the vaccine experienced a temperature excursion of -14 degrees Celsius to -10 degrees Celsius for 8 hours as recorded by a data logger. No previous temperature excursion was reported. There was no adverse effect reported.; Sender's Comments:  US-009507513-1909USA002960: US-009507513-1909USA006331: US-009507513-1909USA006332: US-009507513-1909USA006333: US-009507513-1909USA006330: US-009507513-1909USA006329: US-009507513-1909USA006328: US-009507513-1909USA006341:
Sex: U
Vaccine: MMRV, MMRV
Symptoms: No adverse event, Product storage error
Clinical narrative: No adverse effect reported; one patient received an improperly stored VARlVAX; This spontaneous report was received from a nurse and concerns to a 4-year-old patient of unknown gender. The patient's historical condition, and drug reactions or allergies were not reported. Concomitant therapies included sterile diluent.     On 21-AUG-2019, the patient was vaccinated with an improperly stored dose of measles, mumps, rubella and varicella (Oka-Merck) Virus Vaccine Live (PROQUAD) (dosage schedule, route, anatomical location were not reported) (it cannot be determined with which lot number was vaccinated the patient (R026722 and expiration date 17-MAR-2020 or R023499 and expiration date 13-FEB-2020)) for prophylaxis. The administered dose of the vaccine experienced a temperature excursion of -14 degrees Celsius to -10 degrees Celsius for 8 hours as recorded by a data logger. No previous temperature excursion was reported. There was no adverse effect reported.; Sender's Comments:  US-009507513-1909USA002867: US-009507513-1909USA006334: US-009507513-1909USA006329: US-009507513-1909USA006328: US-009507513-1909USA003228: US-009507513-1909USA003010: US-009507513-1909USA002971: US-009507513-1909USA002960: US-009507513-1909USA006332: US-009507513-1909USA006333: US-009507513-1909USA006330: US-009507513-1909USA006334: US-009507513-1909USA006328: US-009507513-1909USA006329: US-009507513-1909USA006331:
Sex: U
Vaccine: VARCEL, VARCEL
Symptoms: No adverse event, Product storage error
Clinical narrative: No adverse effect reported; one patient received an improperly stored VARlVAX; This spontaneous report was received from a nurse and concerns to a 4 year old patient of unknown gender. The patient's historical condition, and drug reactions or allergies were not reported. Concomitant therapies included sterile diluent.   On 28-AUG-2019,  the patient was vaccinated with an improperly stored dose of varicella virus vaccine live (oka/merck)(VARIVAX) (dosage schedule, route, anatomical location were not reported)(it can not be determined with which lot number was vaccinated the patient (R006221 and expiration date 29-FEB-2020 or R029517 and expiration date 14-OCT-2020)) for prophylaxis. The administered dose of the vaccine experienced a temperature excursion of -14 degrees Celsius to -10 degrees Celsius for 8 hours as recorded by a data logger. No previous temperature excursion was reported. There was no adverse effect reported.; Sender's Comments:  US-009507513-1909USA002960: US-009507513-1909USA006331: US-009507513-1909USA006332: US-009507513-1909USA006333: US-009507513-1909USA006334: US-009507513-1909USA006329: US-009507513-1909USA006328: US-009507513-1909USA006341:
Age: 2.0
Sex: M
Vaccine: FLU4
Symptoms: Injection site bruising, Injection site erythema, Injection site induration, Injection site irritation, Injection site swelling
Clinical narrative: 24 HOURS after vaccine was given, it was noticed that the patient's injection site was very red, irritated, swollen, hard and warm  to the touch, and appeared bruised.  The area was approximately 3 inches wide. Patient did not have any other concerns  other than local irritation. Patient was given motrin and cold compresses to the swollen /affected area.
Age: 2.0
Sex: M
Vaccine: FLU4
Symptoms: Injection site warmth
Clinical narrative: 24 HOURS after vaccine was given, it was noticed that the patient's injection site was very red, irritated, swollen, hard and warm  to the touch, and appeared bruised.  The area was approximately 3 inches wide. Patient did not have any other concerns  other than local irritation. Patient was given motrin and cold compresses to the swollen /affected area.
Age: 32.0
Sex: F
Vaccine: FLU4
Symptoms: Injection site erythema, Injection site pain, Injection site swelling
Clinical narrative: Patient reported soreness, redness, and swelling where the shot was given.
Age: 76.0
Sex: F
Vaccine: FLUA3, PPV
Symptoms: Erythema, Pyrexia, Swelling
Clinical narrative: REDNESS, SWELLING, HIGH TEMPERATURE. PER PATIENT PNEUMOVAX WAS GIVEN ON LEFT ARM.
Age: 37.0
Sex: F
Vaccine: FLU4
Symptoms: Asthenia, Pruritus, Pulse abnormal
Clinical narrative: full body itching onset approximately 6 or 7 pm, lasting until after I took Benedryl and fell asleep around midnight. Felt weak with weak pulse.
Age: 1.08
Sex: F
Vaccine: HEP, HEPA, MMR, VARCEL
Symptoms: Febrile convulsion, Heart rate increased, Pyrexia, Vomiting
Clinical narrative: Fever, Febrile Seizures
Age: 58.0
Sex: F
Vaccine: VARZOS
Symptoms: Chills, Feeling abnormal, Headache, Malaise, Nausea
Clinical narrative: headache, body aches, chills, nausea, feeling so sick that I had to go to bed last night and still not feeling right this morning
Age: 58.0
Sex: F
Vaccine: VARZOS
Symptoms: Pain
Clinical narrative: headache, body aches, chills, nausea, feeling so sick that I had to go to bed last night and still not feeling right this morning
Age: 1.0
Sex: F
Vaccine: DTAPHEPBIP, HEPA, HIBV, MMR, PNC13, VARCEL
Symptoms: Productive cough, Pyrexia, Vomiting, White blood cell count increased
Clinical narrative: Grandmother refers that the child had a fever and was vomiting with phlegm.
Age: 54.0
Sex: F
Vaccine: VARZOS
Symptoms: Chills, Fatigue, Feeling abnormal, Feeling cold, Headache
Clinical narrative: my arm was a little sore on monday, and the site of injection was red... Tuesday the red area had grown to about 3" in diameter.  Tuesday about 5 pm, I started having chills and felt like I was freezing, muscle aches, head aches, exhausted but was not able to sleep.  Wednesday, I feel like someone hit me with a baseball bat, and  the injection site is red and inflamed.
Age: 54.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site erythema, Injection site inflammation, Insomnia, Myalgia, Pain in extremity
Clinical narrative: my arm was a little sore on monday, and the site of injection was red... Tuesday the red area had grown to about 3" in diameter.  Tuesday about 5 pm, I started having chills and felt like I was freezing, muscle aches, head aches, exhausted but was not able to sleep.  Wednesday, I feel like someone hit me with a baseball bat, and  the injection site is red and inflamed.
Age: 0.58
Sex: M
Vaccine: DTAPIPV, HIBV, PNC13, RV5
Symptoms: No adverse event, Product administered to patient of inappropriate age
Clinical narrative: Kinrix was given to a 7 mo old new patient for her Dtap/IPV immunization requirement.  The child was behind on his shots though the kinrix is only approved for kids at least 4 yo.  Mom notified 9/18/19.  No unusual local reaction.  No fever.  Doing well.  Have had contact with the CDC regarding this error - this dose of the Dtap & IPV do not need to be repeated.
Sex: U
Vaccine: RV5
Symptoms: No adverse event, Product storage error
Clinical narrative: No adverse effects; a patient was administered an improperly stored ROTATEQ.; This spontaneous report was received from a nurse referring to a patient of unknown age and gender. Information about medical history, concurrent conditions and concomitant therapies was not provided.     On 22-AUG-2019 the patient was vaccinated with rotavirus vaccine, live, oral, pentavalent (ROTATEQ) (lot # S010702, expiration date 16-JAN-2021; strength, route, dose and frequency were not reported) for prophylaxis (improper storage of product in use)and no adverse effects. The outcome of the event was unknown.
Sex: F
Vaccine: HPV9
Symptoms: Menstrual disorder, Oligomenorrhoea
Clinical narrative: The menstrual cycle as being "normal at first".However, the patient continued bleeding and is still bleeding at the time of the report The patient reported that the bleeding is "mainly at night with some clotting"; The patient does not normally have a menstrual cycle that lasts 2.5 weeks; This spontaneous report was received from the medical assistant, referring to a 25-year-old female patient. The patient's pertinent history was not provided, it was reported that the patient did not have previously drug reactions or allergies. The patient's concurrent conditions included genital herpes, and his concomitant therapies included acyclovir, anxiety, depression, and acid reflux medications.   On 18-JUN-2019 the patient was vaccinated with the first dose of hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast) (GARDASIL 9) injection (lot number and expiration date were not reported), and on 19-AUG-2019 the patient received the second dose hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast) (GARDASIL 9) injection, lot number 1602283 has been verified to be valid for hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast); expiration date 16-AUG-2019); both vaccines were administered intramuscularly, in left deltoid, as disease prevention. On 19-AUG-2019, the patient began her menstrual cycle which was on time, the patient reported that the menstrual cycle as being normal as first, however the patient continued bleeding, and the bleeding was mainly at night with some clotting (menorrhagia). The patient's menstrual cycle had lasts 2.5 weeks (menstrual disorder). It was reported that the patient did not received any treatment for the events, and neither laboratory diagnostics or studies were performed to the patient, however it was reported that the patient called to the physician for sought medical attention.   At the time of this report, the outcome of the events menorrhagia and menstrual disorder was reported as not recovered.  The relatedness between the aforementioned events and therapy with hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast)(GARDASIL 9)  was not reported.
Sex: U
Vaccine: HEPA, MMR, RV5
Symptoms: No adverse event, Product storage error
Clinical narrative: patients received improperly stored doses of vaccines; No adverse effects reported; This spontaneous report was received from a nurse and refers to multiple unspecified patients of unknown age and gender. Patients' s concurrent conditions, concomitant therapies, previous drug reactions, allergies, historical drugs or medical history were not reported.  Since 12-JUN-2019, on multiple unspecified dates, the patients received improperly stored doses (product storage error) of: (rha) measles, mumps, and rubella (wistar ra 27-3) virus vaccine, live (M-M-R II) lot numbers R014690 and R002510 with expiration dates on 23-MAY-2020 and 25-JAN-2020 respectively; rotavirus vaccine, live, oral, pentavalent (ROTATEQ) lot numbers R035673, R015439, and R003111 with expiration dates on 19-SEP-2020, 19-APR-2020, and 12-SEP-2019 respectively; and hepatitis a vaccine, inactivated (VAQTA) lot numbers R018935, expiration date on R018935 (strength, dose, frequency, route of administration, anatomical location, and indication were not reported for all therapies). The lot number and expiration date for properly stored sterile diluent ( Merck sharp and Dhome) use to reconstitute (rha) measles, mumps, and rubella (wistar ra 27-3) virus vaccine, live (M-M-R II) were unknown by the reporter. There was no adverse effect reported.  The administered doses of vaccine experienced a temperature of excursion of 61.5 degrees Fahrenheit and the highest above 47 degrees Fahrenheit (9 degrees Celsius) for 6 hours and 15 minutes. The previous temperature of excursion was 46.7 degrees Fahrenheit and the highest above 47 degrees Fahrenheit (9 degrees Celsius) for 1 hour. Data logger was involved.
Sex: U
Vaccine: VARCEL
Symptoms: No adverse event, Product storage error
Clinical narrative: No adverse effect reported; On 27-AUG-2019, one patient received an improperly stored VARlVAX; This spontaneous report was received from a nurse and concerns to a 4 year old patient of unknown gender. The patient's historical condition, and drug reactions or allergies were not reported. Concomitant therapies included sterile diluent.     On 27-AUG-2019,  the patient was vaccinated with an improperly stored dose of varicella virus vaccine live (oka/merck)(VARIVAX) (dosage schedule, route, anatomical location were not reported)(it can not be determined which lot number was vaccinated the patient (R006221 and expiration date 29-FEB-2020 or R029517 and expiration date 14-OCT-2020)) for prophylaxis. The administered dose of the vaccine experienced a temperature excursion of -14 degrees Celsius to -10 degrees Celsius for 8 hours as recorded by a data logger. No previous temperature excursion was reported. There was no adverse effect reported.; Sender's Comments:  US-009507513-1909USA006332: US-009507513-1909USA006331: US-009507513-1909USA006333: US-009507513-1909USA006330: US-009507513-1909USA006334: US-009507513-1909USA006329: US-009507513-1909USA006328:
Sex: F
Vaccine: MMRV
Symptoms: No adverse event, Product storage error
Clinical narrative: No adverse effect reported.; received improperly stored PROQUAD; Information has been received from a medical assistant referring to a 11 year old female patient. Concomitant therapy included sterile diluent. Information about concurrent condition, drug reactions/allergies and medical history was not provided.  On 16-AUG-2019, the patient received improperly stored measles, mumps, rubella and varicella (oka-merck) virus vaccine live (PROQUAD) (therapy type was rHA, lot # was R015741, expiration date was 02-DEC-2019; strength and route were not reported) for prophylaxis; reconstituted with properly stored sterile diluent (lot # and expiration were unknown by the reporter). No adverse effects were reported.  The vaccine had temperature excursion of 6 Fahrenheit (F) degree to 14F degree (14F degree) for 1 hour and 8 minutes. Previous temperature excursion of 15F degree to 46F degree (42.8F degree) for 37 hours and 7 minutes. The call was due to the digital data logger.
Sex: F
Vaccine: HPV4
Symptoms: Injected limb mobility decreased
Clinical narrative: Not able to move her arm; This spontaneous report was received from a consumer refers to a female patient of unknown age. The patient's medical history, concurrent conditions, historical dugs and concomitant medications were not reported. On an unknown date, the patient was vaccinated with quadrivalent human papillomavirus (types 6,11,16,18) recomb. vaccine (GARDASIL) (strength, dose, frequency, route, lot # and expiration date not reported) for prophylaxis. On an unknown date, the patient was not able to move her arm (injected limb mobility decreased). The outcome of injected limb mobility decreased was unknown. The causality assessment was not provided by the reporter.  This is one of several reports received from the same reporter.; Sender's Comments:  US-009507513-1909USA005356:
Sex: U
Vaccine: VARCEL
Symptoms: No adverse event, Product storage error
Clinical narrative: No adverse effects reported; Improperly stored vaccine was administered to one patient; Assistant confirmed route of administration was "intramuscular"; This spontaneous report was received from a medical assistant, referring to a patient of unknown age and gender. The patient's historical drugs, medical history, concomitant therapies and concurrent conditions were not reported.  On 13-SEP-2019, the patient was vaccinated with an improperly stored dose of varicella virus vaccine live (oka/merck)(VARIVAX) 0.5 ml, once, intramuscularly, lot No. S002736, expiration date 28-JAN-2021, for prophylaxis (strength was not reported). Varicella virus vaccine live (Oka/Merck) (VARIVAX) was reconstituted with a properly stored sterile diluent (MERCK STERILE DILUENT), possible lot # S000130, expiration date reported as 23-AUG-2021.  The temperature excursion was of 8.1 Fahrenheit degrees (°F), during 20 minutes. However, a previous temperature excursion of 8.1°F for 17 minutes and 9.5°F for 21 minutes were also reported. A digital data logger was involved. No adverse effects were reported.
Sex: U
Vaccine: HEPA
Symptoms: Expired product administered, No adverse event
Clinical narrative: No adverse symptoms reported; the patient was vaccinated with expired VAQTA (R021233 exp 9/5/2019); This spontaneous report was received from a nurse, referring to a patient of unknown age and gender. The patient's historical drugs, medical history, concomitant therapies and concurrent conditions were not reported.  On 16-SEP-2019, the patient was vaccinated with an expired dose of  hepatitis a vaccine, inactivated(VAQTA) lot# R021233, expiration date 05-SEP-2019, for prophylaxis (strength, dose, route and frequency were not reported). No adverse symptoms reported.  The nurse stated that hepatitis a vaccine, inactivated(VAQTA) did not have any temperature excursions prior to vaccination.
Sex: U
Vaccine: MMRV
Symptoms: No adverse event, Product storage error
Clinical narrative: No adverse effect reported; one patient received an improperly stored VARlVAX; This spontaneous report was received from a nurse and concerns to a 5 year old patient of unknown gender. The patient's historical condition, and drug reactions or allergies were not reported. Concomitant therapies included sterile diluent.   On 21-AUG-2019,  the patient was vaccinated with an improperly stored dose of measles, mumps, rubella and varicella (Oka-Merck) Virus Vaccine Live (PROQUAD)(dosage schedule, route, anatomical location were not reported)(it can not be determined with which lot number was vaccinated the patient (R026722 and expiration date 17-MAR-2020 or R023499 and expiration date 13-FEB-2020)) for prophylaxis. The administered dose of the vaccine experienced a temperature excursion of -14 degrees Celsius to -10 degrees Celsius for 8 hours as recorded by a data logger. No previous temperature excursion was reported. There was no adverse effect reported.; Sender's Comments:  US-009507513-1909USA002960: US-009507513-1909USA006332: US-009507513-1909USA006333: US-009507513-1909USA006330: US-009507513-1909USA006334: US-009507513-1909USA006329: US-009507513-1909USA006328: US-009507513-1909USA006341:
Sex: U
Vaccine: MMRV, MMRV
Symptoms: No adverse event, Product storage error
Clinical narrative: No adverse effect reported; one patient received an improperly stored VARlVAX; This spontaneous report was received from a nurse and concerns to a 4-year-old patient of unknown gender. The patient's historical condition, and drug reactions or allergies were not reported. Concomitant therapies included sterile diluent.    On 21-AUG-2019, the patient was vaccinated with an improperly stored dose of measles, mumps, rubella and varicella (Oka-Merck) Virus Vaccine Live (PROQUAD)(dosage schedule, route, anatomical location were not reported)(it cannot be determined with which lot number was vaccinated the patient (R026722 and expiration date 17-MAR-2020 or R023499 and expiration date 13-FEB-2020)) for prophylaxis. The administered dose of the vaccine experienced a temperature excursion of -14 degrees Celsius to -10 degrees Celsius for 8 hours as recorded by a data logger. No previous temperature excursion was reported. There was no adverse effect reported.; Sender's Comments:  US-009507513-1909USA002960: US-009507513-1909USA006331: US-009507513-1909USA006333: US-009507513-1909USA006330: US-009507513-1909USA006334: US-009507513-1909USA006329: US-009507513-1909USA006328: US-009507513-1909USA006341:
Age: 25.0
Sex: F
Vaccine: TDAP
Symptoms: Exposure during pregnancy
Clinical narrative: VACCINE EXPOSURE DURING PREGNANCY; This prospective pregnancy case was reported by a healthcare professional and described the occurrence of vaccine exposure during pregnancy in a 25-year-old female subject who was vaccinated with tetanus toxoid, reduced diphtheria toxoid and acellular pertussis vaccine, adsorbed (Boostrix, GlaxoSmithKline) for prophylaxis during pregnancy.   The subject's past medical history included two previous pregnancies resulting in normal births of two full-term infants with no defects.  Prior to becoming pregnant the subject had not been using contraception.  On 7 September 2011 at 12:00 the subject received a booster dose of Boostrix (o.5 unknown units, intramuscular, left arm), and experienced vaccine exposure during the third trimester of her pregnancy.  The conception was reported to be normal.  The subject was approximately 28 weeks gestation at the time of vaccination.  Date of last menstrual period was 25 January 2011 and estimated delivery date was 27 November 2011.  Prenatal testing including ultrasounds on 11 April 2011 and 20 June 2011, and maternal serum alpha-fetoprotein on 10 June 2011, had revealed no evidence of a defect.   Upon internal review done on 17th September 2019, the pregnancy outcome was updated to lost to follow-up.      Lab Comments: Lab Tests: Ultrasound tests on 11 April 2011 and 20 June 2011 revealed no evidence of a defect. Maternal serum alpha-fetoprotein on 10 June 2011 revealed no evidence of a defect.
Age: 24.0
Sex: F
Vaccine: TDAP
Symptoms: Alpha 1 foetoprotein normal, Exposure during pregnancy, Prenatal screening test, Ultrasound antenatal screen normal
Clinical narrative: VACCINE EXPOSURE DURING PREGNANCY; This prospective pregnancy case was reported by a healthcare professional and described the occurrence of vaccine exposure during pregnancy in a 24-year-old female subject who was vaccinated with tetanus toxoid, reduced diphtheria toxoid and acellular pertussis vaccine, adsorbed (Boostrix, GlaxoSmithKline) for prophylaxis during pregnancy.   The subject's past medical history included one previous pregnancy resulting in normal birth of a full-term infant with no defects.  The subject had not been using contraception prior to becoming pregnant.  On an unspecified date the subject received a dose of Boostrix (intramuscular, unknown site), and experienced vaccine exposure during pregnancy.  Gestational age at the time of vaccination was unspecified.  Date of last menstrual period was 03 March 2011 and estimated date of delivery was 08 December 2011.  The conception was reported to be normal.  Prenatal testing including ultrasound on 26 July 2011 and maternal serum alpha-fetoprotein on 29 June 2011 had revealed no evidence of a defect.   Upon internal review done on 17th September 2019, the pregnancy outcome was updated to lost to follow-up.      Lab Comments: Lab Tests: Ultrasound on 26 July 2011 and maternal serum alpha-fetoprotein on 29 June 2011 revealed no evidence of a defect.
Age: 19.0
Sex: F
Vaccine: TDAP
Symptoms: Exposure during pregnancy
Clinical narrative: VACCINE EXPOSURE DURING PREGNANCY; This prospective pregnancy case was reported by a healthcare professional and described the occurrence of vaccine exposure during pregnancy in a 19-year-old female subject who was vaccinated with tetanus toxoid, reduced diphtheria toxoid and acellular pertussis vaccine, adsorbed (Boostrix, GlaxoSmithKline) for prophylaxis during pregnancy.   The subject's past medical history included no previous pregnancies.  The subject had not been using contraception before becoming pregnant.  On 21 September 2011 the subject received booster dose of Boostrix (.5 ml, intramuscular, unknown site), and experienced vaccine exposure during the third trimester of her pregnancy.  The conception was reported to be normal.  The subject was approximately 28 weeks gestation at the time of vaccination.  Date of last menstrual period was 05 March 2011 and estimated date of delivery was 10 December 2011.  Prenatal testing including ultrasound on 14 June 2011 and maternal serum alpha-fetoprotein on 22 July 2011 had revealed no evidence of a defect.   Upon internal review done on 17th September 2019, the pregnancy outcome was updated to lost to follow-up.       Lab Comments: Lab Tests: Ultrasound on 14 June 2011 and maternal serum alpha-fetoprotein on 22 July 2011 revealed no evidence of a defect.
Age: 34.0
Sex: F
Vaccine: TDAP
Symptoms: Exposure during pregnancy, Prenatal screening test, Ultrasound antenatal screen normal
Clinical narrative: VACCINE EXPOSURE DURING PREGNANCY; This prospective pregnancy case was reported by a healthcare professional and described the occurrence of vaccine exposure during pregnancy in a 34-year-old female subject who was vaccinated with tetanus toxoid, reduced diphtheria toxoid and acellular pertussis vaccine, adsorbed (Boostrix, GlaxoSmithKline) for prophylaxis during pregnancy.   The subject's medical history included drug abuse, and four previous pregnancies resulting in one elective abortion, one spontaneous abortion, and two normal births of infants.  Concurrent medical conditions included drug abuse on methadone.  The subject was not using contraception prior to becoming pregnant.  On an unspecified date the subject received a dose of Boostrix (intramuscular, unknown site), and experienced vaccine exposure during pregnancy.  Gestational age at the time of vaccination was unknown.  The conception was reported to be normal.  Date of last menstrual period was 19 January 2011 and estimated date of delivery was 26 October 2011.  Prenatal testing including ultrasounds on 22 April 2011 and 28 June 2011 and sequencial screening had revealed no evidence of a defect.   Upon internal review done on 18th September 2019, the pregnancy outcome was updated to lost to follow-up.      Lab Comments: Lab Tests: Ultrasound on 22 April 2011 and 28 June 2011 revealed no evidence of a defect. Sequencial screen revealed no evidence of a defect.
Age: 20.0
Sex: F
Vaccine: TDAP
Symptoms: Exposure during pregnancy
Clinical narrative: VACCINE EXPOSURE DURING PREGNANCY; This prospective pregnancy case was reported by a healthcare professional and described the occurrence of vaccine exposure during pregnancy in a 20-year-old female subject who was vaccinated with tetanus toxoid, reduced diphtheria toxoid and acellular pertussis vaccine, adsorbed (Boostrix, GlaxoSmithKline) for prophylaxis during pregnancy.   The subject's past medical history included no previous pregnancies.  The subject was not using contraception prior to becoming pregnant.  On 22 September 2011 the subject received a dose of Boostrix (.5 unknown units, intramuscular, unknown site), and experienced vaccine exposure during the second trimester of her pregnancy.  The subject was approximately 26 weeks gestation at the time of vaccination.  The conception was reported to be normal.  Date of last menstrual period was 19 March 2011 and estimated date of delivery was 24 December 2011.  Prenatal testing including ultrasound on 16 August 2011 had revealed no evidence of a defect.  Maternal serum alpha-fetoprotein had been declined.   Upon internal review done on 18th September 2019, the pregnancy outcome was updated to lost to follow-up.      Lab Comments: Lab Tests: Ultrasound on 16 August 2011 had revealed no evidence of a defect.
Age: 35.0
Sex: F
Vaccine: TDAP
Symptoms: Exposure during pregnancy
Clinical narrative: VACCINE EXPOSURE DURING PREGNANCY; This prospective pregnancy case was reported by a healthcare professional and described the occurrence of vaccine exposure during pregnancy in a 35-year-old female subject who was vaccinated with tetanus toxoid, reduced diphtheria toxoid and acellular pertussis vaccine, adsorbed (Boostrix, GlaxoSmithKline) for prophylaxis during pregnancy.   The subject's medical history included two previous pregnancies resulting in two spontaneous abortions.  Prior to becoming pregnant the subject was not using contraception.  On 31 August 2011 the subject received booster dose of Boostrix (.5 unknown units, intramuscular, unknown site), and experienced vaccine exposure during the second trimester of her pregnancy.  The subject was approximately 21 weeks gestation at the time of vaccination.  The conception was reported to be normal.  Date of last menstrual period was 02 April 2011 and estimated date of delivery was 07 January 2012.  Prenatal testing including ultrasound and maternal serum alpha-fetoprotein on 01 August 2011 had revealed no evidence of a defect.   Upon internal review done on 18th September 2019, the pregnancy outcome was updated to lost to follow-up.       Lab Comments: Lab Tests: Ultrasound and maternal serum alpha-fetoprotein on 01 August 2011 revealed no evidence of a defect.
Sex: U
Vaccine: VARZOS
Symptoms: Diarrhoea, Headache, Influenza like illness, Malaise, Nausea
Clinical narrative: soreness; nausea; headache; body ache; flu like symptoms; not feeling well; diarrhea; This case was reported by a pharmacist via call center representative and described the occurrence of pain in arm in a adult patient who received Herpes zoster (Shingrix) for prophylaxis.   On an unknown date, the patient received Shingrix at an unknown dose. On an unknown date, less than 2 years after receiving Shingrix, the patient experienced pain in arm, nausea, headache, general body pain, influenza-like symptoms, feeling unwell and diarrhea. On an unknown date, the outcome of the pain in arm, nausea, headache, general body pain, influenza-like symptoms, feeling unwell and diarrhea were unknown.   It was unknown if the reporter considered the pain in arm, nausea, headache, general body pain, influenza-like symptoms, feeling unwell and diarrhea to be related to Shingrix.  Additional details were provided as follows: This case was reported by the pharmacist on behalf of her co-worker who spoke about another patient who had similar side effects, however, her co-worker had no details to provide. The patient demographic details were not provided. The age group of the patient was not reported, but selected as an adult as per vaccine indication. The age at vaccination was not reported. The patient experienced pain in arm, nausea, headache, general body pain, influenza-like symptoms, feeling unwell and diarrhea, after vaccination with dose of Shingrix. The reporter consented to follow up. This case has been linked with case US2019158433, reported by same reporter.