chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 61.0
Sex: F
Vaccine: VARZOS, VARZOS
Symptoms: Incomplete course of vaccination, Vulvovaginal dryness, Vulvovaginal pain
Clinical narrative: Vaginal Dryness; Pain initiating at vaginal area; Inappropriate schedule of vaccine; This case was reported by a nurse via call center representative and described the occurrence of vaginal dryness in a 61-year-old female patient who received Herpes zoster (Shingrix) (batch number M77B4, expiry date 18th February 2021) for prophylaxis.   Co-suspect products included Herpes zoster (Shingrix) for prophylaxis.   On 2nd August 2018, the patient received the 1st dose of Shingrix. On an unknown date, the patient received the 2nd dose of Shingrix. On an unknown date, less than a year after receiving Shingrix and not applicable after receiving Shingrix, the patient experienced vaginal dryness, vaginal pain and inappropriate schedule of vaccine administered. On an unknown date, the outcome of the vaginal dryness and vaginal pain were recovered/resolved and the outcome of the inappropriate schedule of vaccine administered was unknown.   It was unknown if the reporter considered the vaginal dryness and vaginal pain to be related to Shingrix.  Additional details were reported as follows: The patient received Shingrix initially and experienced vaginal dryness and pain that had lasted several months. The patient did not received 2nd dose of Shingrix, which led to incomplete course of vaccination. No further information provided.
Sex: M
Vaccine: PNC13
Symptoms: Urticaria
Clinical narrative: Hives; This is a spontaneous report from a contactable other hcp on behalf of physician .   A 6-month-old male patient received the 3rd dose of pneumococcal 13-val conj vac (dipht crm197 protein) (PREVNAR 13), via an unspecified route of administration at single dose in the thigh on an unspecified date in Mar2019 for immunisation. The patient medical history was not reported. There were no concomitant medications. The patient previously took 2 doses of Prevnar 13 on unknown dates for immunisation. In Apr2019, the patient experienced hives with outcome of recovered in Apr2019. The event was described as follows: The mother reported that the patient started with hives, two days after receiving the injection. The hives lasted for about a week and then they were gone. The doctor would like to run a test to see if it may have been caused by the polysorbate. Patient received three vaccines total at that time. He received two in one thigh and one in the other thigh.  The information on the Lot / Batch number has been requested.
Sex: M
Vaccine: PNC13
Symptoms: Erythema, Peripheral swelling, Skin warm
Clinical narrative: arm was sort of swollen, red, hot to the touch and it was warm; arm was sort of swollen, red, hot to the touch and it was warm; arm was sort of swollen, red, hot to the touch and it was warm; This is a spontaneous report from a contactable consumer. A male patient of an unspecified age receive pneumococcal 13-valent conjugate vaccine (diphtheria CRM197 protein) (PREVNAR 13, lot number X13847, expiration date Jul2020), via an unspecified route of administration from an unspecified date at a single dose for an immunization. The patient's medical history and concomitant medications were not reported. It was reported that the patient's arm was sort of swollen, red, hot to touch and it was warm after the vaccine was administered a couple of days ago, on an unspecified date. The outcome of the event was unknown.
Age: 71.0
Sex: M
Vaccine: PPV
Symptoms: Hypoaesthesia, Immediate post-injection reaction, Impaired work ability, Injection site pain, Pain
Clinical narrative: ImmediaTe pain aT site of injection. Pain increased over severaL hours. Very painful To LifT arm. LosT work for week. Pain conTinued for 2 months. Pain aT injecTion site for another month. numbness in right Thumb, pain!
Age: 71.0
Sex: F
Vaccine: VARZOS
Symptoms: Pain in extremity, Palpitations, Pyrexia
Clinical narrative: Tylenol for fever of 101 & Pain in arm Racing heartbeat
Age: 47.0
Sex: F
Vaccine: MMR
Symptoms: Contraindication to vaccination
Clinical narrative: Client given MMR on 4-19-19 along with PCV 13, Influenza and Shingrix.   Client came in on 4-26-19 for Hib, Hep B and Meningococcal (did not want to get all at the same time).  It was noticed on 4-26-19 that client was inadvertently given MMR that should not have been given until 2 years post transplant.  Client denied any problems from vaccines given on 4-19-19.  Nurse attempted to contact client's physician - Dr. after realizing the MMR was given.  Physician and staff gone for the day.  Called physician this morning gave message to nurse.
Age: 54.0
Sex: F
Vaccine: MMR
Symptoms: Abdominal discomfort, Diarrhoea, Hyperhidrosis, Measles post vaccine, Migraine
Clinical narrative: felt bad week of 4/22 nausea, upset stomach, Wed 24th had diarrhea, headache migraine-type, sweating all week (unusual) while working. Worked 4-22, 4/24, 4/25, 4/26, 4/27.  Rash developed 4/26. No reported places of patients known to have measles. Rash worsened on Sat 4/27 seen by RN diagnosed with vaccine-related Measles. She was measles screening at the time
Age: 54.0
Sex: F
Vaccine: MMR
Symptoms: Nausea, Rash
Clinical narrative: felt bad week of 4/22 nausea, upset stomach, Wed 24th had diarrhea, headache migraine-type, sweating all week (unusual) while working. Worked 4-22, 4/24, 4/25, 4/26, 4/27.  Rash developed 4/26. No reported places of patients known to have measles. Rash worsened on Sat 4/27 seen by RN diagnosed with vaccine-related Measles. She was measles screening at the time
Age: 64.0
Sex: F
Vaccine: UNK
Symptoms: Injection site erythema, Injection site pain, Injection site pruritus, Injection site swelling
Clinical narrative: Redness, pain swelling, irritation and itching at injection site.
Age: 71.0
Sex: F
Vaccine: VARZOS
Symptoms: Vomiting
Clinical narrative: Unable to keep down any fluid (even sucking on Ice cubes) or food.   Threw up every liquid/food I tried to take from Friday morning until Sunday afternoon when the Emergency room drs gave me intravenous fluids and medication to settle the stomach.   After treatment, was slowly able to take fluids but took another day before I could tolerate food.
Age: 13.0
Sex: M
Vaccine: HPV9
Symptoms: Injection site erythema, Rash, Urticaria, Vaccination site swelling, Vaccination site warmth
Clinical narrative: HPV was administered at 5:30pm.  Patient did consume some Wavy Potato Chips and French Onion dip approximately 1 hour later.  Around 8pm patient complained of a rash.  Mother gave Benadryl before bed and rash largely disappeared- woke up the next morning with  hives on arms, legs and face and vaccine site was red, warm and swollen.  Denies any difficulty breathing. Advised parent to monitor next few days, benadryl prn and to report what happens next few days to help figure what was going on.  Also to avoid the chips and dip until known cause.  Parent was told to come in if symptoms continue or to ER for difficulty breathing or swallowing.
Age: 62.0
Sex: F
Vaccine: VARZOS
Symptoms: Chills, Fatigue, Injection site erythema, Injection site pruritus, Injection site swelling
Clinical narrative: Developed fever and chills, 103F, body aches, which lasted about 24 hours; left with fatigue for another 24 hours. Injection site was swollen, red, hot with raised area about 4 x 4". Applied cold compress, took ibuprofen. Swelling and pain receded within 3 days, but injection site is still itchy. This was the second dose. The first dose was similar, but less severe.
Age: 62.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site warmth, Pain, Pyrexia
Clinical narrative: Developed fever and chills, 103F, body aches, which lasted about 24 hours; left with fatigue for another 24 hours. Injection site was swollen, red, hot with raised area about 4 x 4". Applied cold compress, took ibuprofen. Swelling and pain receded within 3 days, but injection site is still itchy. This was the second dose. The first dose was similar, but less severe.
Age: 57.0
Sex: F
Vaccine: VARZOS
Symptoms: Arthralgia, Chills, Hypophagia, Nausea, Pain
Clinical narrative: Intense chills, followed by body aches, joint aches, fever 100-101, severe nausea preventing any oral intake that day, in addition to the expected soreness in the arm.
Age: 57.0
Sex: F
Vaccine: VARZOS
Symptoms: Pain in extremity, Pyrexia
Clinical narrative: Intense chills, followed by body aches, joint aches, fever 100-101, severe nausea preventing any oral intake that day, in addition to the expected soreness in the arm.
Age: 36.0
Sex: F
Vaccine: TDAP
Symptoms: Erythema, Mobility decreased, Pain in extremity, Peripheral swelling
Clinical narrative: C/o Arm pain, swelling, redness, loss of movement-started on 4/4/2019, went to doctor on 4/6/2019, recieved prednisone and mobic at that time, unsure of subsequent symptoms and timeline
Age: 57.0
Sex: F
Vaccine: VARZOS
Symptoms: Asthenia, Chills, Diarrhoea, Feeling hot, Frequent bowel movements
Clinical narrative: Woken with worst headache imaginable, unable to sip water, intense nausea, frequent stool x 7-8 that morning, body aches, chills, then feeling hot. Unable to keep eyes open due to the headache severity.  Extreme malaise.    This lasted in a severe form for over 14 hours. Then, able to sit up and take some sips of water without the nausea.  By the next day, felt very weak with milder headache but able to take in applesauce and crackers.  Continued to feel overall shaky and weak for 4 more days.  Watery diarrhea started on 4/26 x 1 day.  Also: Arm soreness (expected) at injection site.
Age: 57.0
Sex: F
Vaccine: VARZOS
Symptoms: Headache, Injection site pain, Malaise, Nausea, Pain
Clinical narrative: Woken with worst headache imaginable, unable to sip water, intense nausea, frequent stool x 7-8 that morning, body aches, chills, then feeling hot. Unable to keep eyes open due to the headache severity.  Extreme malaise.    This lasted in a severe form for over 14 hours. Then, able to sit up and take some sips of water without the nausea.  By the next day, felt very weak with milder headache but able to take in applesauce and crackers.  Continued to feel overall shaky and weak for 4 more days.  Watery diarrhea started on 4/26 x 1 day.  Also: Arm soreness (expected) at injection site.
Age: 57.0
Sex: F
Vaccine: VARZOS
Symptoms: Photophobia, Tremor
Clinical narrative: Woken with worst headache imaginable, unable to sip water, intense nausea, frequent stool x 7-8 that morning, body aches, chills, then feeling hot. Unable to keep eyes open due to the headache severity.  Extreme malaise.    This lasted in a severe form for over 14 hours. Then, able to sit up and take some sips of water without the nausea.  By the next day, felt very weak with milder headache but able to take in applesauce and crackers.  Continued to feel overall shaky and weak for 4 more days.  Watery diarrhea started on 4/26 x 1 day.  Also: Arm soreness (expected) at injection site.
Age: 2.0
Sex: M
Vaccine: DTAP, HEP, IPV, MMRV
Symptoms: Circumstance or information capable of leading to medication error, Irritability
Clinical narrative: This child was getting his shots as part of a catch-up series.  Two injections were given in each leg by two practitioners, doing them simultaneously for the first pair and simultaneously for the second pair of vaccines.  Between the first and second vaccine, the child began to fuss and his arm got loose.  After the vaccines were over and as one practitioner was leaving the room, that practitioner noticed own left hand bleeding from a scrape approx. 3 inches long.  We are not sure but it seems a vaccine needle caused the scrape to the practitioner which was not felt or noticed during vaccination.  No injury to the patient.
Age: 0.5
Sex: M
Vaccine: DTAPHEPBIP, FLU4, PNC13
Symptoms: Rash
Clinical narrative: PATIENT RECIEVED VACCINE ADMINISTRATION AT APPROXIMATELY 1220 ON 4/29/19.  APPROXIMATELY 10 MINUTES AFTER ADMINISTRATION PATIENT HAD RASH ON SCALP, HEAD/FACE, BACK, UPPER CHEST AND ABDOMINAL AREA. NURSE WAS IN ROOM WITH PATIENT AT THE TIME AND IMMEDIATLY NOTIFIED CHARGE NURSE.  CHARGE NURSE URGENT CARE  WITHIN CLINIC AND PATIENT AND PARENT ESCORTED TO TREATMENT ROOM FOR OBSERVATION, EVALUATION AND IF NEEDED, TREATMENT.    PATIENT WAS THEN DISCHARGED FROM DEPARTMENT AFTER EVALUATION FROM PROVIDER.
Age: 1.83
Sex: F
Vaccine: DTAP
Symptoms: Guillain-Barre syndrome
Clinical narrative: gullian barre syndrome for 3 days
Age: 67.0
Sex: F
Vaccine: HEP
Symptoms: Headache, Hypoaesthesia, Paraesthesia, Paraesthesia oral
Clinical narrative: Patient came to employee health to obtain second hepatitis B vaccine.  First vaccine was given 2/15/2019.  IM injection given  4/29/19 around 11:30 am and she left employee health office to go to lab to obtain some other lab work.  She returned 30 minutes later and stated she was having tingling in her lips, left side facial numbness, headache, and then about 5 minutes later stated her left arm was numb and tingling.  I took her straight to our Emergency Dept.  There she was treated by the ED doctor and staff.
Sex: U
Vaccine: VARZOS
Symptoms: Herpes zoster
Clinical narrative: shingles; Products liability: manufacturing defect/defective design; This initial spontaneous report was received from a lawyer regarding a case in litigation and refers to a currently 72 years old patient of unspecified gender. No information was received regarding medical history, concurrent conditions, or concomitant medications.  On an unspecified date in 2007, the patient was vaccinated with zoster vaccine live (ZOSTAVAX) injection (dose, strength, route and site of administration, lot# and expiration date were not reported) for the long-term prevention of shingles and zoster-related conditions. On an unspecified date, the patient was treated for the following injuries resulting from the patient's zoster vaccine live (ZOSTAVAX) use: shingles. The patient claimed damages as a result of: Injury to themselves; Loss of consortium; Loss of services; Economic losses. The following claims were asserted: negligence; products liability - defective design; products liability - manufacturing defect; products liability-failure to warn; breach of express warranty; breach of implied warranty; fraudulent misrepresentation; fraudulent concealment; negligent misrepresentation; unjust enrichment; strict liability; consumer fraud; loss of consortium; punitive damages. The outcome of the events was not provided. The causality between the event of shingles and the suspect therapy was reported as related. The causality between the product quality issue and zoster vaccine live (ZOSTAVAX) was not provided.
Sex: U
Vaccine: HPV9
Symptoms: No adverse event, Product storage error
Clinical narrative: vaccine coordinator reports no adverse effects for all patients; Administration of 6 separate doses of an improperly stored vaccine to 6 separate patients; This spontaneous report was received from a vaccine coordinator concerning patient of unknown age and gender. The patient's medical history, concurrent conditions, concomitant therapies, historical drugs or allergies were not provided.  On 24-APR-2019, the patient was vaccinated with an improperly stored dose of hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast)(GARDASIL 9) lot number: R021636 and expiration date 12-MAY-2021, intramuscularly (strength, dose, anatomical site, frequency were not reported) for prophylaxis.  The administered dose of the vaccine experienced a temperature excursion of 50 degrees Fahrenheit (°F) for 1 hour. There was no previous temperature excursion and the call was because of a data logger. No adverse effects reported. No product quality complaint was involved.  This is one of six reports received from the same reporter.; Sender's Comments:  US-009507513-1904USA012683: US-009507513-1904USA012710: US-009507513-1904USA012721: US-009507513-1904USA012754: US-009507513-1904USA012756:
Sex: U
Vaccine: HPV9
Symptoms: No adverse event, Product storage error
Clinical narrative: vaccine coordinator reports no adverse effects for all patients; Administration of 6 separate doses of an improperly stored vaccine to 6 separate patients; This spontaneous report was received from a vaccine coordinator concerning patient of unknown age and gender. The patient's medical history, concurrent conditions, concomitant therapies, historical drugs or allergies were not provided.  On 24-APR-2019, the patient was vaccinated with an improperly stored dose of hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast)(GARDASIL 9) lot number: R021636 and expiration date 12-MAY-2021, intramuscularly (strength, dose, anatomical site, frequency were not reported) for prophylaxis.  The administered dose of the vaccine experienced a temperature excursion of 50 degrees Fahrenheit (°F) for 1 hour. There was no previous temperature excursion and the call was because of a data logger. No adverse effects reported. No product quality complaint was involved.  This is one of six reports received from the same reporter.; Sender's Comments:  US-009507513-1904USA011371:
Age: 57.0
Sex: F
Vaccine: TD
Symptoms: Full blood count, Injection site erythema, Injection site oedema, Injection site warmth
Clinical narrative: Erythema, warmth, edema to (L) Humerus 7cm x 11cm.
Age: 17.0
Sex: M
Vaccine: HPV9
Symptoms: Hypoaesthesia
Clinical narrative: Right Sided Numbness/ Hand, arm and foot
Age: 1.83
Sex: M
Vaccine: MMR
Symptoms: Wrong product administered
Clinical narrative: Patient was given an MMR in error instead of Prevnar 13 that was ordered
Age: 4.0
Sex: M
Vaccine: DTAPIPV, MMRV
Symptoms: Dyspnoea, Erythema, Urticaria
Clinical narrative: APPROXIMATELY 30 MINUTES FROM VACCINE INJECTION  MOM RETURNED WITH PATIENT HAVING HIVES, REDNESS OF FACE AND UPPER BODY AND INCREASED WORK OF BREATHING .  PULSE OX 95%  BEFORE GIVING (1MG/ML) EPINEPHRINE GIVEN 0.15 IM LEFT THIGH - AND SINGLE  (COMBINATION OF ALBUTEROL / IPATROPIUM) BREATHING TREATMENT.  REDNESS GREATLY IMPROVED , PULSE OX INCREASED TO 98%  ON  ROOM AIR  SCHEDULED FOLLOW UP TOMORROW
Age: 23.0
Sex: F
Vaccine: FLUC4
Symptoms: Dental operation, Face injury, Fall, Head injury, Jaw fracture
Clinical narrative: The patient experienced a vasovagal syncope episode mere minutes after receiving the shot. The patient fell to the ground, striking her face and head on concrete, and severely breaking her jaw and teeth.
Age: 23.0
Sex: F
Vaccine: FLUC4
Symptoms: Jaw operation, Syncope, Tooth fracture
Clinical narrative: The patient experienced a vasovagal syncope episode mere minutes after receiving the shot. The patient fell to the ground, striking her face and head on concrete, and severely breaking her jaw and teeth.
Age: 59.0
Sex: F
Vaccine: VARZOS
Symptoms: Influenza like illness, Pyrexia
Clinical narrative: fever 99.7  flu like body ach  lasted 36 hours    First dose fever higher but did not take aleive IBprofin
Age: 45.0
Sex: M
Vaccine: TDAP
Symptoms: Erythema, Induration, Skin lesion, Skin warm
Clinical narrative: Warm, erythematous, indurated, non fluctuating  skin lesion on lateral deltoid.
Age: 0.5
Sex: F
Vaccine: DTAPIPVHIB
Symptoms: Abnormal behaviour, Dyspnoea, Feeling abnormal, Gastrooesophageal reflux disease, Joint contracture
Clinical narrative: Hand tremors, wrist curling, waking up with high pitch screams, Spacey, stopped cooing, stopped laughing and smiley, gasping or air when sleeping, body quivering, uncontrolled twitching, shoulder and neck stiffness, listlessness
Age: 0.5
Sex: F
Vaccine: DTAPIPVHIB
Symptoms: Listless, Muscle twitching, Musculoskeletal stiffness, Screaming, Stool analysis
Clinical narrative: Hand tremors, wrist curling, waking up with high pitch screams, Spacey, stopped cooing, stopped laughing and smiley, gasping or air when sleeping, body quivering, uncontrolled twitching, shoulder and neck stiffness, listlessness
Age: 0.5
Sex: F
Vaccine: DTAPIPVHIB
Symptoms: Tremor, Urinary tract infection, Urine analysis abnormal
Clinical narrative: Hand tremors, wrist curling, waking up with high pitch screams, Spacey, stopped cooing, stopped laughing and smiley, gasping or air when sleeping, body quivering, uncontrolled twitching, shoulder and neck stiffness, listlessness
Age: 66.0
Sex: F
Vaccine: VARZOS
Symptoms: Aphthous ulcer, Ear pain, Oral herpes, Oral pain, Pain in jaw
Clinical narrative: After the patient's first Shingrix vaccine on 1/7/19, the patient reported having cold sores around her mouth that developed and resolved within a week after receiving the vaccine. Now, about 12 days after receiving the second vaccine in the series, the patient developed about 15 canker sores inside her mouth. These canker sores were located in all parts of the mouth, but were primarily located where the patient had previous dental work/extractions. These canker sores lasted for about 4-5 days and were very painful, forcing the patient to avoid solid foods during that time. Additionally, the patient also reported to have sharp ear pain and jaw pain during the same time the canker sores were present. The ear and jaw pain also resolved about 4-5 days later.
Age: 10.0
Sex: M
Vaccine: IPV, MMR, TDAP, VARCEL
Symptoms: Syncope
Clinical narrative: Approx. 2 mins. after receiving immunizations, pt. had syncope episode, vital signs and pt.  monitored for15 mins.
Sex: U
Vaccine: HEP, HEP
Symptoms: Extra dose administered, Inappropriate schedule of product administration, Interchange of vaccine products, No adverse event
Clinical narrative: the patient the third dose in RECOMBIVAX HB series less than six months after receiving the first dose.; No adverse effects reported.; Interchange of vaccine products; Reporter stated that patient "was administered a booster of ENGERIX-B; This spontaneous report was received from a nurse concerning to a patient of unknown age and gender. The patient's historical conditions, concurrent condition, and concomitant medications were not provided.  On 01-MAR-2004, the nurse reported that the patient was vaccinated with the first dose of hepatitis b vaccine (recombinant) (RECOMBIVAX HB) (strength, route of administration, anatomical location, lot number, and expiration date were not provided); on 03-MAY-2004, was vaccinated with the second dose of hepatitis b vaccine (recombinant) (RECOMBIVAX HB) (strength, route of administration, anatomical location, lot number, and expiration date were not provided),  and on 17-JUN-2019, the patient received the third dose of with hepatitis b vaccine (recombinant) (RECOMBIVAX HB) 5/0.5 mcrg/ml ( route of administration, anatomical location, lot number, and expiration date were not provided) as prophylaxis,  series less than six months after receiving the first dose (inappropriate schedule of product administration). No adverse effects reported. On 22-APR-2019, the nurse reported that the patient was administered with hepatitis b virus vaccine rhbsag (yeast)(ENGERIX-B) (strength, route of administration, anatomical location, lot number, and expiration date were not provided) (interchange of vaccine products) (extra dose administered) as prophylaxis.  The nurse also reported that multiple unspecified dates, multiples unspecified patients also received the third shot of hepatitis b vaccine (recombinant) (RECOMBIVAX HB) series earlier than 6 months. No adverse effects reported.
Sex: F
Vaccine: MMRV
Symptoms: Expired product administered, No adverse event
Clinical narrative: A patient received an expired dose of PROQUAD; No known adverse effects; This spontaneous report was received from a....regarding a female patient of unknown age. The patient's concurrent conditions, medical history, drug reactions/allergies and concomitant therapies were not reported.  On 25-APR-2019, the patient received an expired dose of Measles, Mumps, Rubella and Varicella (Oka-Merck) Virus Vaccine Live (rHA)(PROQUAD) lot number N021727, expiration date 06-FEB-2019 (route of administration and dosage were not provided) for prophylaxis. No known adverse effects were reported.
Age: 68.0
Sex: F
Vaccine: PPV
Symptoms: Injection site pain
Clinical narrative: Left upper arm pain persistant and increasing
Age: 0.75
Sex: M
Vaccine: DTAPHEPBIP, PNC13
Symptoms: Abnormal behaviour, Aphasia, Blood heavy metal increased, Crying, Developmental delay
Clinical narrative: Patient broke out in a rash from head to toe. He went silent. He stopped babbling and trying to talk. He  would cry constantly and could not be soothed. I didn't know it was a reaction to the vaccine and a month later we moved away. It was only months ago I connected all the dots and got confirmation he was injured by vaccines. His diet has been changed, vitamins/supplements/enzymes have been added to his diet, and he started speech therapy.
Age: 0.75
Sex: M
Vaccine: DTAPHEPBIP, PNC13
Symptoms: Diagnostic procedure, Emotional distress, Mood swings, Personality change, Rash generalised
Clinical narrative: Patient broke out in a rash from head to toe. He went silent. He stopped babbling and trying to talk. He  would cry constantly and could not be soothed. I didn't know it was a reaction to the vaccine and a month later we moved away. It was only months ago I connected all the dots and got confirmation he was injured by vaccines. His diet has been changed, vitamins/supplements/enzymes have been added to his diet, and he started speech therapy.
Age: 0.75
Sex: M
Vaccine: DTAPHEPBIP, PNC13
Symptoms: Scan, Speech disorder developmental
Clinical narrative: Patient broke out in a rash from head to toe. He went silent. He stopped babbling and trying to talk. He  would cry constantly and could not be soothed. I didn't know it was a reaction to the vaccine and a month later we moved away. It was only months ago I connected all the dots and got confirmation he was injured by vaccines. His diet has been changed, vitamins/supplements/enzymes have been added to his diet, and he started speech therapy.
Age: 56.0
Sex: F
Vaccine: VARZOS
Symptoms: Contusion, Feeling hot, Malaise, Mobility decreased, Nausea
Clinical narrative: patient reported swelling, hot to touch a bruise the size of a dime; she became sick with nausea and vomiting, she said she felt very hot all over and had some pain. patient stated she couldn't move .
Age: 56.0
Sex: F
Vaccine: VARZOS
Symptoms: Pain, Skin warm, Swelling, Vomiting
Clinical narrative: patient reported swelling, hot to touch a bruise the size of a dime; she became sick with nausea and vomiting, she said she felt very hot all over and had some pain. patient stated she couldn't move .
Age: 18.0
Sex: F
Vaccine: TDAP
Symptoms: Syncope
Clinical narrative: Patient fainted within 1 minute of receiving the vaccine.  Patient was sitting down at the time so she did not hit the ground.  Her head tilted backward and hit the computer keyboard (but not hard).  Patient awoke within 30 seconds.   Patient was laid down for approximately 10 minutes.  Patient was alert, conscious, aware of her situation.  After ten minutes she was completely back to normal and was able to leave 10 minutes after that on her own power with no problems.
Age: 1.0
Sex: M
Vaccine: VARCEL
Symptoms: Varicella post vaccine, Varicella virus test positive
Clinical narrative: developed chicken pox the day after receiving shot. Doctors office cultured a vesicle and came back positive for varicella.
Age: 60.0
Sex: F
Vaccine: VARZOS
Symptoms: Arthralgia, Back pain, Blister, Burning sensation, Headache
Clinical narrative: patient received Shingrix injection 04/24/19 in right arm, and the next day had pain and redness in area of injection. Right side of back had burning sensation and poking pain, then on 04/26/19 developed a rash in back and front. on 04/27/19 started having muscle pain, joint pain & headaches and saw blisters.
Age: 60.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site erythema, Injection site pain, Myalgia, Rash
Clinical narrative: patient received Shingrix injection 04/24/19 in right arm, and the next day had pain and redness in area of injection. Right side of back had burning sensation and poking pain, then on 04/26/19 developed a rash in back and front. on 04/27/19 started having muscle pain, joint pain & headaches and saw blisters.
Age: 16.0
Sex: M
Vaccine: MENB
Symptoms: Band neutrophil count, Blood calcium normal, Blood chloride normal, Blood creatinine normal, Blood glucose normal
Clinical narrative: Patient developed chills, fatigue, clammy, fever,  lightheadedness, nausea, vomiting, near syncope at least 2 hours after vaccine administration. Patient was taken to Urgent care where BP was 60 systolic. Patient was rushed to the ER, given IVF in transport. Patient was observed in the ER and discharged the same day.
Age: 16.0
Sex: M
Vaccine: MENB
Symptoms: Blood potassium normal, Blood sodium normal, Blood urea normal, Carbon dioxide normal, Chills
Clinical narrative: Patient developed chills, fatigue, clammy, fever,  lightheadedness, nausea, vomiting, near syncope at least 2 hours after vaccine administration. Patient was taken to Urgent care where BP was 60 systolic. Patient was rushed to the ER, given IVF in transport. Patient was observed in the ER and discharged the same day.
Age: 16.0
Sex: M
Vaccine: MENB
Symptoms: Cold sweat, Dizziness, Fatigue, Haematocrit normal, Haemoglobin normal
Clinical narrative: Patient developed chills, fatigue, clammy, fever,  lightheadedness, nausea, vomiting, near syncope at least 2 hours after vaccine administration. Patient was taken to Urgent care where BP was 60 systolic. Patient was rushed to the ER, given IVF in transport. Patient was observed in the ER and discharged the same day.
Age: 16.0
Sex: M
Vaccine: MENB
Symptoms: Lymphocyte percentage decreased, Nausea, Neutrophil percentage, Platelet count normal, Presyncope
Clinical narrative: Patient developed chills, fatigue, clammy, fever,  lightheadedness, nausea, vomiting, near syncope at least 2 hours after vaccine administration. Patient was taken to Urgent care where BP was 60 systolic. Patient was rushed to the ER, given IVF in transport. Patient was observed in the ER and discharged the same day.
Age: 16.0
Sex: M
Vaccine: MENB
Symptoms: Pyrexia, Vomiting, White blood cell count normal
Clinical narrative: Patient developed chills, fatigue, clammy, fever,  lightheadedness, nausea, vomiting, near syncope at least 2 hours after vaccine administration. Patient was taken to Urgent care where BP was 60 systolic. Patient was rushed to the ER, given IVF in transport. Patient was observed in the ER and discharged the same day.
Age: 4.0
Sex: M
Vaccine: DTAPIPV, MMRV
Symptoms: Erythema, Pain, Pruritus, Swelling
Clinical narrative: Large area of Redness and  swelling , itchy and pain
Age: 70.0
Sex: F
Vaccine: PNC13
Symptoms: Cellulitis, Drug hypersensitivity
Clinical narrative: 4/11/2019 diagnosis - cellulitis of left upper extremity
Age: 1.0
Sex: F
Vaccine: PNC13
Symptoms: Crying, Irritability, Vomiting
Clinical narrative: Fussy, crying, vomiting
Age: 50.0
Sex: M
Vaccine: PPV
Symptoms: Arthralgia, Body temperature increased, Chest X-ray normal, Chills, Cough
Clinical narrative: redness/swelling at injection site, intermittent up  103, chills, cough, diarrhea, joint pain, frontal headache, light sensitivity, diarrhea
Age: 50.0
Sex: M
Vaccine: PPV
Symptoms: Diarrhoea, Headache, Injection site erythema, Injection site swelling, Photophobia
Clinical narrative: redness/swelling at injection site, intermittent up  103, chills, cough, diarrhea, joint pain, frontal headache, light sensitivity, diarrhea
Age: 69.0
Sex: F
Vaccine: PNC13, TDAP
Symptoms: Blister, Injection site erythema, Pain in extremity, Pruritus, Secretion discharge
Clinical narrative: Patient received Adacel and Prevnar 13 in left arm on 4/22/19.  ( she also received Twinrix and Shingrix in the right arm).  Patient returned today on 4/29/19 and her left arm is red and hot to the touch.  It is red at the injection site and the redness progresses down her arm.  It does not progress below the elbow.  She stated her arm was sore the evening after receiving the vaccinations and warm to the touch.  She stated during the first night, "a blister came up and oozed a little".  She did have a small sore on her arm and she said that was were the blister was, but the blister/sore location was NOT the site of either injection.  Her  arm was red in this location, as well as in the deltoid muscle region.  The patient stated the redness did not start until about 3 days after receiving the vaccinations.  She said the redness has not gotten worse, but it has not gotten better.  She stated her arm does not hurt, but it does itch.
Age: 69.0
Sex: F
Vaccine: PNC13, TDAP
Symptoms: Skin warm
Clinical narrative: Patient received Adacel and Prevnar 13 in left arm on 4/22/19.  ( she also received Twinrix and Shingrix in the right arm).  Patient returned today on 4/29/19 and her left arm is red and hot to the touch.  It is red at the injection site and the redness progresses down her arm.  It does not progress below the elbow.  She stated her arm was sore the evening after receiving the vaccinations and warm to the touch.  She stated during the first night, "a blister came up and oozed a little".  She did have a small sore on her arm and she said that was were the blister was, but the blister/sore location was NOT the site of either injection.  Her  arm was red in this location, as well as in the deltoid muscle region.  The patient stated the redness did not start until about 3 days after receiving the vaccinations.  She said the redness has not gotten worse, but it has not gotten better.  She stated her arm does not hurt, but it does itch.
Age: 5.0
Sex: M
Vaccine: VARCEL
Symptoms: Eye movement disorder
Clinical narrative: Abnormal involuntary eye movement
Age: 1.0
Sex: M
Vaccine: HEPA, MMR, VARCEL
Symptoms: Injection site erythema, Injection site urticaria, Local reaction
Clinical narrative: Within minutes of injection to left thigh, this patient developed redness and hives on left thigh. Patient's doctor assessed the localized reaction, recommended OTC antihistamine and ice to affected area and return to clinic for any worsening symptoms or concerns.
Age: 7.0
Sex: F
Vaccine: VARCEL
Symptoms: Erythema, Pain, Skin warm, Swelling
Clinical narrative: REDNESS , SWELLING, PAIN AND WARMTH
Age: 75.0
Sex: M
Vaccine: VARZOS
Symptoms: Rash
Clinical narrative: Patient reported painful rash on his trunk and back a few days after receiving shingrix vaccine.  He went to his doctor and they gave him a steroid - they were unable to conclude what the rash.
Age: 20.0
Sex: M
Vaccine: ANTH, SMALL, TYP, VARCEL
Symptoms: Arrhythmia, Brain natriuretic peptide normal, Chest pain, Echocardiogram normal, Electrocardiogram abnormal
Clinical narrative: Dx: Vaccinia-related myopericarditis Patient experienced acute onset 9/10 substernal chest pain on the evening of 26April with no other symptoms.  The pain was worse with lying down and did not relieve with rest.  ER evaluation revealed elevated troponin and ECG consistent with pericarditis.   An echocardiogram was done and revealed normal LV and RV size and function without wall motion abnormality.  Observation for 48 hours with minor arrhythmia (non-sustained ventricular tachycardia x3 beats on 2 episodes).  He has follow-up with Cardiology and a planned cardiac MRI
Age: 20.0
Sex: M
Vaccine: ANTH, SMALL, TYP, VARCEL
Symptoms: Full blood count normal, Laboratory test normal, Myocarditis, Pericarditis, Troponin increased
Clinical narrative: Dx: Vaccinia-related myopericarditis Patient experienced acute onset 9/10 substernal chest pain on the evening of 26April with no other symptoms.  The pain was worse with lying down and did not relieve with rest.  ER evaluation revealed elevated troponin and ECG consistent with pericarditis.   An echocardiogram was done and revealed normal LV and RV size and function without wall motion abnormality.  Observation for 48 hours with minor arrhythmia (non-sustained ventricular tachycardia x3 beats on 2 episodes).  He has follow-up with Cardiology and a planned cardiac MRI
Age: 20.0
Sex: M
Vaccine: ANTH, SMALL, TYP, VARCEL
Symptoms: Vaccination complication, Ventricular tachycardia
Clinical narrative: Dx: Vaccinia-related myopericarditis Patient experienced acute onset 9/10 substernal chest pain on the evening of 26April with no other symptoms.  The pain was worse with lying down and did not relieve with rest.  ER evaluation revealed elevated troponin and ECG consistent with pericarditis.   An echocardiogram was done and revealed normal LV and RV size and function without wall motion abnormality.  Observation for 48 hours with minor arrhythmia (non-sustained ventricular tachycardia x3 beats on 2 episodes).  He has follow-up with Cardiology and a planned cardiac MRI
Age: 68.0
Sex: F
Vaccine: VARZOS
Symptoms: Immediate post-injection reaction, Neck pain, Pain in extremity
Clinical narrative: I am writing to inform you of a very painful reaction I had when I received the first of my two Shingles vaccination.  As soon as the pharmacist put it in, I about jumped off my chair which has never happened when receiving shots.  About and hour and a half later, my arm started to have sharp pain that seemed to extend from my fingers to the middle back of my neck.  I was in terrible pain for about 24 hours, moderate pain for another 24 and then started to recover.
Age: 65.0
Sex: F
Vaccine: PNC13
Symptoms: Erythema, Pyrexia, Swelling
Clinical narrative: pt states redness up to the size of 4 inch diameter, swelling, slight fever and a slight bump
Age: 38.0
Sex: M
Vaccine: MMR
Symptoms: Malaise, Pruritus, Rash
Clinical narrative: Rash onset, itchy, malaise.
Age: 67.0
Sex: M
Vaccine: FLU4
Symptoms: Computerised tomogram, Musculoskeletal pain
Clinical narrative: patient indicates he had a sore shoulder since. HAs seen his PCP who indicated a nerve may have been hit accidentally
Age: 11.0
Sex: F
Vaccine: HPV9, TDAP
Symptoms: Blood glucose normal, Contusion, Dizziness, Drug screen negative, Electrocardiogram normal
Clinical narrative: She fainted twice (back-to-back) while dressing for school in the morning- less than 3 days after  receiving the vaccines.   She also received the dtap vaccine at the same time, but I am not sure who the manufacturer was.  There were no explainable obvious reasons for her fainting.   She had never experienced syncope before.   She lost consciousness and fell, hitting her face resulting in bruises.   She was taken to the emergency room.
Age: 11.0
Sex: F
Vaccine: HPV9, TDAP
Symptoms: Eosinophil percentage increased, Face injury, Fall, Full blood count, Loss of consciousness
Clinical narrative: She fainted twice (back-to-back) while dressing for school in the morning- less than 3 days after  receiving the vaccines.   She also received the dtap vaccine at the same time, but I am not sure who the manufacturer was.  There were no explainable obvious reasons for her fainting.   She had never experienced syncope before.   She lost consciousness and fell, hitting her face resulting in bruises.   She was taken to the emergency room.
Age: 11.0
Sex: F
Vaccine: HPV9, TDAP
Symptoms: Metabolic function test, Syncope, Urine analysis normal, Vertigo
Clinical narrative: She fainted twice (back-to-back) while dressing for school in the morning- less than 3 days after  receiving the vaccines.   She also received the dtap vaccine at the same time, but I am not sure who the manufacturer was.  There were no explainable obvious reasons for her fainting.   She had never experienced syncope before.   She lost consciousness and fell, hitting her face resulting in bruises.   She was taken to the emergency room.
Age: 76.0
Sex: M
Vaccine: VARZOS
Symptoms: Blood culture negative, Chest pain, Cough, Electrocardiogram normal, Influenza like illness
Clinical narrative: flu like symptoms progressing to chest Pain and Cough requiring an ER visit on Apr 14
Age: 76.0
Sex: M
Vaccine: VARZOS
Symptoms: Troponin, X-ray normal
Clinical narrative: flu like symptoms progressing to chest Pain and Cough requiring an ER visit on Apr 14
Age: 4.0
Sex: M
Vaccine: DTAPIPV, MMRV
Symptoms: Cheilitis, Contusion, Rash generalised, Urticaria
Clinical narrative: about 1 hr after vaccines patient returned to office with significant urticarial rash to body, including surrounding lips. No tongue swelling. Prescribed prednisolone x 2 days (initial dose given in office), and Ranitidine x 1 day. Also benadryl given in office and as needed. Rash/bruising mostly cleared after a couple of days. Rash/bruising lasted longest on Right thigh, it finally cleared up on friday afternoon.
Age: 11.0
Sex: M
Vaccine: HPV4, MNQ, TDAP
Symptoms: Injection site pruritus, Injection site swelling, Injection site warmth
Clinical narrative: On 4-27-19, Patient woke up with a very itchy, swollen upper arm.  Very warm to the touch
Age: 11.0
Sex: F
Vaccine: TYP
Symptoms: Abdominal pain upper, Blood test normal, Constipation, Culture stool negative, Decreased appetite
Clinical narrative: This spontaneous case (PVX2019-929) was received from a caregiver on 18-Apr-2019. It describes a female consumer who lost 10-pound weight, had constipation, experienced loss of appetite, vomiting, stomach pain, and occasional headache, after the administration of VIVOTIF for typhoid prophylaxis. Case report: The consumer started VIVOTIF on 19-Mar-2019, and since then she had been vomiting almost daily, along with constant stomach pain and occasional headache. She lost about 10-pound weight as she did not want to eat. As per the reporter, vomiting VIVOTIF was either bile or stomach acid and was either green or yellow. At the time of the report her weight remained the same and she had not lost any additional weight. In addition, it was reported that in late February or early March, before VIVOTIF administration, the consumer attended an environmental camp where she, along with multiple other children became sick. She had vomiting and fever, but no diarrhea. The health department indicated that the children had contracted norovirus. As she was recovering from norovirus, the caregiver held VIVOTIF course and stored it in the refrigerator. After she recovered from the norovirus and everything returned to normal, she started VIVOTIF administration on 19-Mar-2019. Laboratory test included stool samples, H pylori testing, bowel blockage testing, full blood panel, thyroid test, and pancreatitis test. All of the tests were normal. However, according to the bowel X-ray, she had constipation. The reporter additionally mentioned that the consumer had not complained of constipation, however she had "battled with it in the past, a really long time ago". The consumer's past medication included Zantac (ranitidine) for possible reflux, but it had not helped. Action taken with VIVOTIF for the events was unknown. The consumer had not recovered from the events lost 10-pound weight , vomiting, stomach pain, and occasional headache. However, the outcome of the events constipation and loss of appetite was unknown.; Sender's Comments: Company Comment:  In this case, it was reported that an 11-year-old female consumer lost 10-pound weight, had constipation, experienced loss of appetite, vomiting, stomach pain, and occasional headache, after the administration of VIVOTIF. The case has been considered serious as the consumer had significant weight loss.The causality of the events "lost 10-pound weight, had constipation, experienced loss of appetite, vomiting, stomach pain, and occasional headache" is assessed as possible as the events were reported with reasonable time relationship to intake of the vaccine.
Age: 11.0
Sex: F
Vaccine: TYP
Symptoms: Headache, Helicobacter test negative, Laboratory test normal, Pyrexia, Stool analysis normal
Clinical narrative: This spontaneous case (PVX2019-929) was received from a caregiver on 18-Apr-2019. It describes a female consumer who lost 10-pound weight, had constipation, experienced loss of appetite, vomiting, stomach pain, and occasional headache, after the administration of VIVOTIF for typhoid prophylaxis. Case report: The consumer started VIVOTIF on 19-Mar-2019, and since then she had been vomiting almost daily, along with constant stomach pain and occasional headache. She lost about 10-pound weight as she did not want to eat. As per the reporter, vomiting VIVOTIF was either bile or stomach acid and was either green or yellow. At the time of the report her weight remained the same and she had not lost any additional weight. In addition, it was reported that in late February or early March, before VIVOTIF administration, the consumer attended an environmental camp where she, along with multiple other children became sick. She had vomiting and fever, but no diarrhea. The health department indicated that the children had contracted norovirus. As she was recovering from norovirus, the caregiver held VIVOTIF course and stored it in the refrigerator. After she recovered from the norovirus and everything returned to normal, she started VIVOTIF administration on 19-Mar-2019. Laboratory test included stool samples, H pylori testing, bowel blockage testing, full blood panel, thyroid test, and pancreatitis test. All of the tests were normal. However, according to the bowel X-ray, she had constipation. The reporter additionally mentioned that the consumer had not complained of constipation, however she had "battled with it in the past, a really long time ago". The consumer's past medication included Zantac (ranitidine) for possible reflux, but it had not helped. Action taken with VIVOTIF for the events was unknown. The consumer had not recovered from the events lost 10-pound weight , vomiting, stomach pain, and occasional headache. However, the outcome of the events constipation and loss of appetite was unknown.; Sender's Comments: Company Comment:  In this case, it was reported that an 11-year-old female consumer lost 10-pound weight, had constipation, experienced loss of appetite, vomiting, stomach pain, and occasional headache, after the administration of VIVOTIF. The case has been considered serious as the consumer had significant weight loss.The causality of the events "lost 10-pound weight, had constipation, experienced loss of appetite, vomiting, stomach pain, and occasional headache" is assessed as possible as the events were reported with reasonable time relationship to intake of the vaccine.