chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 0.33
Sex: M
Vaccine: DTAP, HIBV
Symptoms: Pallor, Posture abnormal, Unresponsive to stimuli, Urine analysis normal, Wolff-Parkinson-White syndrome
Clinical narrative: On November 9, 2019 at ~ 10:30 AM I was washing patient in the bathroom sink and I noticed his body became limp with decrease in muscle tone.  His eyes were half open and half closed and was extremely pale.  He did not respond to me and I began breastfeeding him.  At that time he started feeding and was able to track me, however, his color was still very pale.  We called on call pediatrician and recommended we take temperature and it was ranging from 96.5 - 97.5 rectally.  She recommended we go to ER.  We monitored him at home for a little bit and then due to him not being his normal chippy self we decided to take to ER.  Patient was very quiet and chill and not as excited as he usually is.  When driving to ER @ ~ 3:00 PM - 4:00 PM he went unresponsive again in the car seat and his head dropped down.  I (mother) took him out of his car seat and noted him arms and legs were limp and began breastfeeding.  He started feeding and was tracking me, but color was very pale again.  We called 911 and he was transported to Medical Center via ambulance.  During ambulance transport patient was stable and did not have any episodes.  He then spent 4 days in the hospital for testing and monitoring.   Patient was discharged on 11.12.2019.  We have follow up appointments with neurology and an electrophysiologist in December 2019.
Age: 66.0
Sex: M
Vaccine: VARZOS
Symptoms: Chills, Decreased appetite, Erythema, Influenza like illness, Insomnia
Clinical narrative: pt stated felt like had the flu. body aches, loss of appetite and nausea for 2 days,  imsomnia due to aches and pain, shiverring, and fever. also had 3 raised red welps come up on the face. 1 under the left eye, one under left nostril, and 1 on lower lip. they did not hurt or itch but took over 2 weeks to heal completely. other symptoms started within a few hours and lasted approxiamately 48 hours.
Age: 66.0
Sex: M
Vaccine: VARZOS
Symptoms: Nausea, Pain, Pyrexia, Urticaria
Clinical narrative: pt stated felt like had the flu. body aches, loss of appetite and nausea for 2 days,  imsomnia due to aches and pain, shiverring, and fever. also had 3 raised red welps come up on the face. 1 under the left eye, one under left nostril, and 1 on lower lip. they did not hurt or itch but took over 2 weeks to heal completely. other symptoms started within a few hours and lasted approxiamately 48 hours.
Age: 9.0
Sex: F
Vaccine: FLU4
Symptoms: Erythema, Fatigue, Local reaction, Pain, Pruritus
Clinical narrative: Fever of 101-102F, fatigue on 11/19/19 and 11/20/19  Large local reaction- red- raised, hot to touch, size of deck of cards, painful and itchy- lasting several days.  No cough, congestion, or signs of URI.  Has had yearly flu vaccines, 1st time had reaction.
Age: 9.0
Sex: F
Vaccine: FLU4
Symptoms: Pyrexia, Skin warm, Swelling
Clinical narrative: Fever of 101-102F, fatigue on 11/19/19 and 11/20/19  Large local reaction- red- raised, hot to touch, size of deck of cards, painful and itchy- lasting several days.  No cough, congestion, or signs of URI.  Has had yearly flu vaccines, 1st time had reaction.
Age: 56.0
Sex: F
Vaccine: VARZOS
Symptoms: Chills, Headache, Injection site swelling, Nausea, Pyrexia
Clinical narrative: Chills, fever - 101.3, nausea, headache, swelling at injection site that has continued to spread
Age: 13.0
Sex: M
Vaccine: HEPA
Symptoms: Incorrect dose administered, No adverse event
Clinical narrative: Gave Hep A adult dose to 13 year old. No adverse effects or treatment
Age: 63.0
Sex: F
Vaccine: TYP
Symptoms: Dyspnoea, Fatigue, Flushing, Headache, Swollen tongue
Clinical narrative: Headache, fatigue, flushing, reports that tongue feels swollen, shortness of breath
Age: 4.0
Sex: F
Vaccine: DTAP, VARCEL
Symptoms: Injection site erythema, Injection site induration, Injection site swelling, Loss of personal independence in daily activities, Pain
Clinical narrative: Patient's mother stated that the swelling and redness started on the night of 11/22/19. By the next morning the injection site was hard and red, swollen and big, Mom stated that child was sore and unable to do much all weekend. 11/24/19 mom stated that the site was 6.5  by 4.5 . This reaction was to the DTaP vaccine on the left thigh. This am 11/25/19 child's leg seems to be going down and is possibly getting better.
Age: 1.0
Sex: U
Vaccine: VARCEL
Symptoms: No adverse event, Product storage error
Clinical narrative: No adverse effects reported; received improperly stored VARIVAX; This spontaneous report was received from a medical assistant referring to six unspecified patients of unknown age and gender. Their medical history, concurrent conditions and drug reactions/allergies were not reported. Concomitant medication included sterile diluent. Since 14-MAR-2019, it was reported that these six patients were vaccinated with improperly stored dose of varicella virus vaccine live (oka/merck) (VARIVAX), lot # R011805 and expiry date: 23-APR-2020, lot # R023503 and expiry date 16-AUG-2020 for prophylaxis (strength, dose, unit, route, anatomical location were not reported). The vaccine was reconstituted with properly stored sterile diluent. The administered doses of the vaccines experienced temperature excursion from above 6 degree Fahrenheit (F) to 14 degree F (7.5 degree F) for five minutes. No previous temperature excursion was reported. The call was due to digital data logger. No adverse effects were reported. No product quality complaint (PQC) was involved.  Follow up information was received from a lead medical assistant refers to 12 month old patient of unknwon gender on 21-NOV-2019. On 02-APR-2019, the patient was vaccinated with improperly stored varicella virus vaccine live (oka/merck) (VARIVAX) lot # R023503 and expiry date 16-AUG-2020 (product storage error).  This is one of several reports received from the same reporter.
Age: 4.0
Sex: U
Vaccine: VARCEL
Symptoms: No adverse event, Product storage error
Clinical narrative: No adverse effects reported; received improperly stored VARIVAX; This spontaneous report was received from lead medical assistant refers to a 4 year old patient of unknown gender. The patient's medical history, concurrent conditions, historical drugs and drug reactions/allergies were not reported. Concomitant medication included sterile diluent. On 22-APR-2019, the patient was vaccinated with improperly stored varicella virus vaccine live (oka/merck) (VARIVAX) lot # R023503 and expiry date 16-AUG-2020 (strength, dose, unit, route, anatomical location were not reported) for prophylaxis (product storage error). The vaccine was reconstituted with properly stored sterile diluent. The administered doses of the vaccines experienced temperature excursion from above 6 degree Fahrenheit (F) to 14 degree F (7.5 degree F) for five minutes. No previous temperature excursion was reported. The call was due to digital data logger. No adverse effects were reported. No product quality complaint (PQC) was involved.  This is one of several reports received from the same reporter.
Age: 3.0
Sex: U
Vaccine: VARCEL
Symptoms: No adverse event, Product storage error
Clinical narrative: This spontaneous report was received from lead medical assistant refers to a 3 year old patient of unknown gender. The patient's medical history, concurrent conditions, historical drugs and drug reactions/allergies were not reported. Concomitant medication included sterile diluent. On 26-APR-2019, the patient was vaccinated with improperly stored VARIVAX lot # R023503 and expiry date 16-AUG-2020 (strength, dose, unit, route, anatomical location were not reported) for prophylaxis (product storage error). The vaccine was reconstituted with properly stored sterile diluent. The administered doses of the vaccines experienced temperature excursion from above 6 degree Fahrenheit (F) to 14 degree F (7.5 degree F) for five minutes. No previous temperature excursion was reported. The call was due to digital data logger. No adverse effects were reported. No product quality complaint (PQC) was involved.   This is one of several reports received from the same reporter.
Age: 14.0
Sex: U
Vaccine: VARCEL
Symptoms: No adverse event, Product storage error
Clinical narrative: No adverse effects reported; received improperly stored VARIVAX; This spontaneous report was received from lead medical assistant refers to a 14 year old patient of unknown gender. The patient's medical history, concurrent conditions, historical drugs and drug reactions/allergies were not reported. Concomitant medication included sterile diluent. On 11-APR-2019, the patient was vaccinated with improperly stored varicella virus vaccine live (oka/merck) (VARIVAX) lot # R023503 and expiry date 16-AUG-2020 (strength, dose, unit, route, anatomical location were not reported) for prophylaxis (product storage error). The vaccine was reconstituted with properly stored sterile diluent. The administered doses of the vaccines experienced temperature excursion from above 6 degree Fahrenheit (F) to 14 degree F (7.5 degree F) for five minutes. No previous temperature excursion was reported. The call was due to digital data logger. No adverse effects were reported. No product quality complaint (PQC) was involved.  This is one of several reports received from the same reporter.
Sex: U
Vaccine: PNC13
Symptoms: Antibody test negative, Fall, Injury, Meningitis pneumococcal, Pyrexia
Clinical narrative: sustained a fall injury; Got a fever within 24 hours; Patient was diagnosed with strep pneumonia meningitis; Patient was diagnosed with strep pneumonia meningitis; This is a spontaneous report from a contactable nurse received via a Pfizer sales representative.  A 7-year-old patient of an unspecified gender received pneumococcal 13-val conj vac (dipht crm197 protein) (PREVNAR 13) via an unspecified route of administration on an unspecified date at single dose for immunization. The patient's medical history and concomitant medications were not reported.  The patient sustained a fall injury and got a fever within 24 hours. Patient was sent to the hospital. Once at the hospital, patient was diagnosed with strep pneumonia meningitis. Titers showed only significant antibodies were 6B and 18C. All other 21 strains tested, including 9 Prevnar 13 serotypes in the panel, were low or absent. Physician recommended booster of PCV13 and PPSV. Lot/batch number has been requested.; Sender's Comments: Based on the information currently available, a lack of efficacy with pneumococcal 13-valent conjugate vaccine in this patient cannot be completely excluded. Fall represents an accidental injury unrelated to vaccine use.  The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to Regulatory Authorities, Ethics Committees and Investigators, as appropriate.
Age: 76.0
Sex: F
Vaccine: PNC13
Symptoms: Inflammation, Injection site irritation, Injection site swelling, Pain, Pain in extremity
Clinical narrative: Having pain when attempts to turn her arm; swelling and inflammation in same arm as injection; swelling and inflammation in same arm as injection; This is a spontaneous report from a contactable pharmacist. A 76-year-old female patient received pneumococcal 13-val conj vac (dipht crm197 protein) (PREVNAR 13) (lot# AG8353, Exp date Jun2021, NDC 00005-1971-02), intramuscular in deltoid left, on 30Oct2019, at 0.5 ml single, for immunisation. Medical history and concomitant medications were none. The patient experienced swelling and inflammation in same arm as injection on 31Oct2019 with outcome of not recovered. The events were considered medically significant. The patient saw her doctor on 04Nov2019 and 06Nov2019. The doctor initially thought it was something else, but now believes it may be a reaction to the vaccination. The reaction started out as some swelling and irritation below the injection site and then it increased up toward the injection site and then went down to patient's hand. Therapeutic measures were taken as a result of the events and included treatment with Clindamycin at 300 mg 3x/day, that was changed to Keflex at 500 mg 3x/day as well as Benadryl. The patient stated her arm was still swollen at this time and she indicated having pain when attempted to turn her arm.; Sender's Comments: There is a reasonable possibility that the events "swelling and inflammation in same arm as injection" were related to pneumococcal 13-valent conjugate vaccine based on known drug safety profile.  The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to regulatory authorities, Ethics Committees, and Investigators, as appropriate.
Age: 76.0
Sex: F
Vaccine: PNC13
Symptoms: Peripheral swelling, Skin irritation
Clinical narrative: Having pain when attempts to turn her arm; swelling and inflammation in same arm as injection; swelling and inflammation in same arm as injection; This is a spontaneous report from a contactable pharmacist. A 76-year-old female patient received pneumococcal 13-val conj vac (dipht crm197 protein) (PREVNAR 13) (lot# AG8353, Exp date Jun2021, NDC 00005-1971-02), intramuscular in deltoid left, on 30Oct2019, at 0.5 ml single, for immunisation. Medical history and concomitant medications were none. The patient experienced swelling and inflammation in same arm as injection on 31Oct2019 with outcome of not recovered. The events were considered medically significant. The patient saw her doctor on 04Nov2019 and 06Nov2019. The doctor initially thought it was something else, but now believes it may be a reaction to the vaccination. The reaction started out as some swelling and irritation below the injection site and then it increased up toward the injection site and then went down to patient's hand. Therapeutic measures were taken as a result of the events and included treatment with Clindamycin at 300 mg 3x/day, that was changed to Keflex at 500 mg 3x/day as well as Benadryl. The patient stated her arm was still swollen at this time and she indicated having pain when attempted to turn her arm.; Sender's Comments: There is a reasonable possibility that the events "swelling and inflammation in same arm as injection" were related to pneumococcal 13-valent conjugate vaccine based on known drug safety profile.  The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to regulatory authorities, Ethics Committees, and Investigators, as appropriate.
Age: 64.0
Sex: F
Vaccine: FLU4
Symptoms: Burning sensation, Erythema, Pain in extremity, Peripheral swelling, Skin irritation
Clinical narrative: 11-22-19 Client at clinic states arm (L) is swollen and on fire. RN assessed (L) arm red, warm, raised skin. Client said it started 11-20-19 - evening and that it hurts. Traced perimeter of redness with marker told client to go to ER if gets worse. Ice pack applied to irritated area on left arm.
Age: 64.0
Sex: F
Vaccine: FLU4
Symptoms: Skin warm
Clinical narrative: 11-22-19 Client at clinic states arm (L) is swollen and on fire. RN assessed (L) arm red, warm, raised skin. Client said it started 11-20-19 - evening and that it hurts. Traced perimeter of redness with marker told client to go to ER if gets worse. Ice pack applied to irritated area on left arm.
Age: 71.0
Sex: F
Vaccine: VARZOS
Symptoms: Asthenia, Chills, Computerised tomogram normal, Electrocardiogram, Fall
Clinical narrative: Felt awful the night after vaccine;  terrible chills, nausea, ringing in ears, still lacks energy 4 days after vaccine.  Adverse event: I passed out the next morning and fell on floor;had small cut on head due to fall; was admitted to hospital after an emergency room examination; spent one night in hospital.
Age: 71.0
Sex: F
Vaccine: VARZOS
Symptoms: Feeling abnormal, Laboratory test, Loss of consciousness, Nausea, Skin laceration
Clinical narrative: Felt awful the night after vaccine;  terrible chills, nausea, ringing in ears, still lacks energy 4 days after vaccine.  Adverse event: I passed out the next morning and fell on floor;had small cut on head due to fall; was admitted to hospital after an emergency room examination; spent one night in hospital.
Age: 71.0
Sex: F
Vaccine: VARZOS
Symptoms: Tinnitus, X-ray normal
Clinical narrative: Felt awful the night after vaccine;  terrible chills, nausea, ringing in ears, still lacks energy 4 days after vaccine.  Adverse event: I passed out the next morning and fell on floor;had small cut on head due to fall; was admitted to hospital after an emergency room examination; spent one night in hospital.
Age: 17.0
Sex: M
Vaccine: FLU4, HEPA, MENB, MNQ
Symptoms: Loss of consciousness
Clinical narrative: Patient passed out after 4th vaccine administration , which was Trumenba. patient was out for less than 5 seconds, came to thinking he was dreaming. Patient remained in room with no other issues.
Age: 16.0
Sex: M
Vaccine: MNQ
Symptoms: Product preparation error
Clinical narrative: Powder was mixed with generic sterile diluent (used for Varicella and/or Proquad) instead of the provided diluent.
Sex: M
Vaccine: FLU3
Symptoms: Asthenia, Blood test, Constipation, Decreased appetite, Depression
Clinical narrative: fever, loss of appetite, night sweats, headache, stomach nausea, constipation, eye sensitivity to light, lethargy, weakness, depression fatigue
Sex: M
Vaccine: FLU3
Symptoms: Fatigue, Headache, Lethargy, Nausea, Night sweats
Clinical narrative: fever, loss of appetite, night sweats, headache, stomach nausea, constipation, eye sensitivity to light, lethargy, weakness, depression fatigue
Sex: M
Vaccine: FLU3
Symptoms: Photophobia, Pyrexia, Urine analysis
Clinical narrative: fever, loss of appetite, night sweats, headache, stomach nausea, constipation, eye sensitivity to light, lethargy, weakness, depression fatigue
Age: 55.0
Sex: F
Vaccine: FLU4
Symptoms: Injected limb mobility decreased, Pain in extremity
Clinical narrative: Two days after getting the vaccine, Patient started to experience right arm pain and decreased ROM. She had a medical appointment on 11/11/19, and was give a Prednisone taper to help. Lab work was ordered as well.
Age: 0.75
Sex: F
Vaccine: DTAPHEPBIP, FLU4, HIBV, IPV, PNC13
Symptoms: Extra dose administered, No adverse event
Clinical narrative: Gave Immunizations not realizing that IPV was in fact Polio. So the patient got an extra dose. Mother of child, was informed, and she has no concerns. The child had no adverse reaction to double dose of Polio.
Age: 65.0
Sex: F
Vaccine: FLU4
Symptoms: Injection site pain
Clinical narrative: Pt came in complaining of pain at injection site. Pt stated is started after flu vaccine on 10/2. Saw specialist on 11/18 who recommended Physical therapy/ nerve block medication and follow up in a few weeks.
Age: 61.0
Sex: M
Vaccine: FLU4
Symptoms: Pruritus
Clinical narrative: Very itchy hands
Age: 50.0
Sex: F
Vaccine: VARZOS
Symptoms: Injected limb mobility decreased, Injection site pain, Pain, Pain in extremity
Clinical narrative: Patient stated that this was the most painful vaccination she has ever had and perhaps the most painful direct infliction of pain.  She felt a stabbing pain in her right arm with pain extending to behind her ear lobe and all the way down to the base of my index finger.    By the time she was traveling home  was to the point of tears with pain shooting up and down her arm with any bump in the road.  She could not lift her arm.  It was not stiff and sore, it was pain, radiating pain.   Duration of pain unknown
Age: 53.0
Sex: F
Vaccine: FLU4, PPV, VARZOS
Symptoms: Injection site erythema, Injection site oedema, Injection site pain
Clinical narrative: Skin:        approx 2 cm local  erythema  at injection sites on Left deltoid. Noncontiguous  erythema, edema and tenderness in series of patches distal & medial along lower L biceps. from middeltoid to above elbow. No papules, vesicles or pustules.
Age: 53.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site erythema, Injection site inflammation, Injection site swelling, Injection site warmth
Clinical narrative: Redness, inflammation, heat and swelling at injection site. Redness radius approximately 10 cm
Age: 28.0
Sex: F
Vaccine: MMR
Symptoms: Arthralgia
Clinical narrative: Joint pain, starting in feet, knees, then hands and elbows at time of visit 11/21/19
Age: 66.0
Sex: F
Vaccine: FLU4, PNC13
Symptoms: Chorioretinitis, Colitis, Ear infection, Pyrexia, Upper respiratory tract infection
Clinical narrative: The following day patient started feeling ill with fever, URI symptoms and ended up on multiple rounds of antibiotic for ear infection. She then developed colitis felt to be inflammatory (not c.diff). She complained of vision changes mid October and saw ophthalmology who referred her to a retinal specialist Dr for chorioretinitis. Dr. felt that that this could have culminated as a side effect from the vaccination she received in September.
Age: 66.0
Sex: F
Vaccine: FLU4, PNC13
Symptoms: Visual impairment
Clinical narrative: The following day patient started feeling ill with fever, URI symptoms and ended up on multiple rounds of antibiotic for ear infection. She then developed colitis felt to be inflammatory (not c.diff). She complained of vision changes mid October and saw ophthalmology who referred her to a retinal specialist Dr for chorioretinitis. Dr. felt that that this could have culminated as a side effect from the vaccination she received in September.
Age: 0.17
Sex: F
Vaccine: DTAPHEPBIP, HIBV, PNC13, UNK
Symptoms: Crying
Clinical narrative: Our daughter cried inconsolably for over 12 hours straight starting within an hour after her vaccines. Nothing helped calm her down. Infant acetaminophen was given after 12 hours of her crying and this seemed to help a little as she was finally able to sleep for a short period of time but then was up crying again. After 24 hours she seemed to be back to her normal state.
Age: 76.0
Sex: F
Vaccine: VARZOS
Symptoms: Erythema, Injection site pain, Injection site swelling, Pyrexia
Clinical narrative: Fever for two days. Redness (started two inches and expanded to 5 inches before fading 7 days later) Pain and swelling of the arm around the site
Age: 17.0
Sex: M
Vaccine: HPV9
Symptoms: Blood test, Visual impairment, Visual snow syndrome
Clinical narrative: Was diagnosed as havign visual snow; Information has been received from the mother of a 17 year old male patient. No medical history, concurrent conditions nor concomitant medications were reported. In March 2019, the patient was vaccinated with dose 1 of hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast) (GARDASIL 9) (strength, route of administration, lot number and expiration date not reported) for prophylaxis. In 2019 (reported as "few months ago"), the patient started to experienced vision issues and was "recently" diagnosed by an ophthalmologist with visual snow (visual snow syndrome). On an unknown date, blood tests were performed; results not reported. At the time of the report, the patient had not recovered from visual snow syndrome.  The causal relationship between visual snow syndrome and hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast) (GARDASIL 9)
Sex: F
Vaccine: VARZOS
Symptoms: Ischaemic stroke
Clinical narrative: ischemic stroke; This initial spontaneous report was received from a lawyer regarding a case in litigation and refers to a female patient of unspecified age . No information was provided regarding medical history, concurrent conditions, or concomitant medications. On or around 21-JUL-2015, the patient was inoculated with zoster vaccine live (ZOSTAVAX) for routine health maintenance and for its intended purpose: the prevention of shingles (herpes zoster). On an unknown date, reported as shortly after receiving zoster vaccine live (ZOSTAVAX) vaccine, the patient suffered from an ischemic stroke. As a direct and proximate result of Company's defective zoster vaccine live (ZOSTAVAX) vaccine, patient's symptoms have resulted in physical limitations not present prior to using Company's product. The patient also experiences mental and emotional distress due to resulting physical limitations and seriousness of her condition. As a result of the manufacture, marketing, advertising, promotion, distribution and/or sale of zoster vaccine live (ZOSTAVAX) , the patient sustained severe and permanent personal injuries. Further, as a tragic consequence of Company's wrongful conduct, the patient suffered serious, progressive, permanent, and incurable injuries, as well as significant conscious pain and suffering, mental anguish, emotional distress, loss of enjoyment of life, physical impairment and injury. As a direct and proximate result of Company's conduct, the patient has suffered and incurred damages, including medical expenses; the loss of accumulations; and other economic and non-economic damages.  Ischemic stroke was considered to be disabling and medically significant.
Age: 52.0
Sex: M
Vaccine: FLU4, VARZOS, VARZOS
Symptoms: Tinnitus
Clinical narrative: Patient got ringing in the ears the day that he got these vaccinations. It improved with Sudafed but still remained. It was worse at night.
Age: 66.0
Sex: M
Vaccine: PPV
Symptoms: Body temperature increased, Chills, Full blood count, Injected limb mobility decreased, Injection site pain
Clinical narrative: Significant onset of pain localized to injection site. Pain began 1 hour after vaccination and became severe 5-6 hours after vaccination with chills, body aches, rigors, inability to move arm. He was sent to ER and admitted overnight for observation. Temperature in ER peaked at 39.5. Overnight pain was improved with prn regimen, by am he was able to move arm better. No redness, warmth, swelling at any time during hospitalization. During reassessment today 11/25/19 by provider PA-C exam showing decreased range of motion left shoulder due to pain. No redness, warmth or swelling of shoulder, left hand slightly more swollen than right.  He had tenderness at left bursa at area of injection per patient.
Age: 66.0
Sex: M
Vaccine: PPV
Symptoms: Leukocytosis, Pain, Peripheral swelling, Ultrasound scan normal, White blood cell count increased
Clinical narrative: Significant onset of pain localized to injection site. Pain began 1 hour after vaccination and became severe 5-6 hours after vaccination with chills, body aches, rigors, inability to move arm. He was sent to ER and admitted overnight for observation. Temperature in ER peaked at 39.5. Overnight pain was improved with prn regimen, by am he was able to move arm better. No redness, warmth, swelling at any time during hospitalization. During reassessment today 11/25/19 by provider PA-C exam showing decreased range of motion left shoulder due to pain. No redness, warmth or swelling of shoulder, left hand slightly more swollen than right.  He had tenderness at left bursa at area of injection per patient.
Age: 29.0
Sex: U
Vaccine: FLU4
Symptoms: Injected limb mobility decreased, Injection site pain
Clinical narrative: Injection site soreness for 1 or 2 days.  About 8 days later there was rapid onset of soreness in the upper arm, shoulder.  Pain was severe that patient had difficulty raising her arm even to apply underarm deodorant.  She reported this to the pharmacy on Nov. 2nd and had physician treatment on Nov. 4th.  She was prescribed Medrol and Naproxen.  In a follow up call after one week, she said that treatment was working.
Age: 82.0
Sex: F
Vaccine: VARZOS
Symptoms: Rash pruritic
Clinical narrative: Rash about 2 inches below the injection site. Appeared 2 days after the immunization was delivered. Rash itched, but did not burn. From patient description, rash seemed to appear just below the deltoid and extend 2-3 inches in length. Rash went away after some time, patient unsure of exact date.
Age: 54.0
Sex: F
Vaccine: VARZOS
Symptoms: Hypoaesthesia, Paraesthesia
Clinical narrative: Tingling and numbness starting in feet, moved up calves and thighs to bottom and pubic area over 3-4 days.  Currently waiting for nerve reaction to subside.
Age: 1.0
Sex: M
Vaccine: FLU4, HEPA, HIBV, MMR, PNC13, VARCEL
Symptoms: Rash macular
Clinical narrative: Patient presented to clinic 11/25/2019 with a  diffuse macular rash. Treatment was supported care, no medications prescribed at this visit. Patient also was seen at an Urgent Care clinic 11/23/2019 and was given Benadryl with no change in the rash.  Rash looks clinically well and will continue to watch and follow up in necessary.
Age: 79.0
Sex: F
Vaccine: PPV
Symptoms: Injected limb mobility decreased, Injection site irritation, Injection site pain
Clinical narrative: Patient said she was having pain from a Pneumonia shot she received quite some time ago.  She stated after getting the shot she had pain for over 2 weeks and could not lift her arm above her head.  Area is still irritated and painful 3 months later.
Age: 72.0
Sex: F
Vaccine: PPV
Symptoms: Dysstasia, Pain in extremity
Clinical narrative: Patient received vaccine around 2pm in the afternoon. Around 6pm as she was cooking supper, he arm started to become very sore. She continued on cooking. After supper, she went to take a shower and was having so much pain, she could not even stand up. It was so excruciating, she took ibuprofen and it provided no relief. She then proceeded to tell her husband she needed to go to the emergency room. Her husband drove her to ER. She was treated with morphine, ketorolac, and lidocaine to take the edge off. She said this did not relief the pain completely. Doctor sent her home with a prescription for hydrocodone, and licodaine. Patient described pain as the worst pain she's ever felt. ER doctor stated he sees 3-4 cases of this each year from this vaccine specifically. Patient still had pain the following day and continued to use pain meds. 3 days later and she is starting to feel better from the pain.
Sex: F
Vaccine: HEP
Symptoms: Unevaluable event
Clinical narrative: unknown effectiveness of vaccine that was administered
Age: 52.0
Sex: F
Vaccine: FLUC4
Symptoms: Hypoaesthesia
Clinical narrative: Numbness in my left arm and hand that started a few hours after receiving the vaccination.  I spoke with my Dr. on  Nov 23, and she prescribed using heat at the injection area and taking Ibuprofen. The numbness is almost continuous.
Sex: M
Vaccine: HEP
Symptoms: Product storage error
Clinical narrative: Effectiveness of vaccine cannot be guaranteed due to temperature excursion
Age: 6.0
Sex: F
Vaccine: FLU3
Symptoms: Injected limb mobility decreased, Injection site bruising, Injection site pain, Injection site swelling
Clinical narrative: EXTREME SWELLING AND PAIN AT SITE couldn't Raise arm Bruising to Elbow towards inner arm from shot given down
Age: 46.0
Sex: F
Vaccine: FLU4, HEP, HEPA
Symptoms: Immediate post-injection reaction, Injection site erythema, Injection site haemorrhage, Injection site swelling
Clinical narrative: Patient came in for vaccines that were due. 11/21/19 vaccines were prepared and verified by LVN. Gave patient (3 dose) Flu vaccine on same arm about an inch apart. Notice there was bleeding and immediately the site began to get swollen, the area became red. Apply gauze to stop bleeding, after gave ice pack to place over the Left deltoid. About 10 min later patien bump went down. Patient was also given Hep A vaccine 2 dose.
Age: 72.0
Sex: F
Vaccine: PNC13
Symptoms: Injection site erythema, Injection site swelling
Clinical narrative: Red area on Rt upper arm 6 1/2 in x 4 1/2 Swollen from 3 in Below shoulder joint to 2 in above elbow Rt arm.
Age: 65.0
Sex: F
Vaccine: VARZOS
Symptoms: Erythema, Fatigue, Feeding disorder, Head discomfort, Headache
Clinical narrative: Large, red, extremely painful sores on roof of mouth; Swollen glands in neck; Swollen tongue; Headache (intense pressure at back of head & in both temples); Fatigue; Continuous from one day after injection and for next 11 days.  However, as of today (11th day after injection), sores on roof of mouth are smaller and less red, but still very painful, making it difficult to eat.  Swollen neck glands & swollen tongue have diminished as of 11th day, but headache is still constant and I continue to be very fatigued.
Age: 65.0
Sex: F
Vaccine: VARZOS
Symptoms: Lymphadenopathy, Oral pain, Stomatitis, Swollen tongue
Clinical narrative: Large, red, extremely painful sores on roof of mouth; Swollen glands in neck; Swollen tongue; Headache (intense pressure at back of head & in both temples); Fatigue; Continuous from one day after injection and for next 11 days.  However, as of today (11th day after injection), sores on roof of mouth are smaller and less red, but still very painful, making it difficult to eat.  Swollen neck glands & swollen tongue have diminished as of 11th day, but headache is still constant and I continue to be very fatigued.
Age: 76.0
Sex: F
Vaccine: FLU3
Symptoms: Erythema
Clinical narrative: Pt?s arm has red marking on it
Age: 82.0
Sex: F
Vaccine: VARZOS
Symptoms: Fatigue, Pyrexia, Rash
Clinical narrative: Patient reported body rash, fever, fatigue, sought treatment at local emergency room.
Sex: U
Vaccine: MMRV
Symptoms: No adverse event, Product storage error
Clinical narrative: No adverse effect; the patient was administede with improperly stored PROQUAD; This spontaneous report was received from a medical assistant referring to a patient of unknown age and gender. Information regarding the patient's concurrent condition and medical history was not provided. On 04-APR-2019, the patient was vaccinated with improperly stored Measles, Mumps, Rubella and Varicella (Oka-Merck) Virus Vaccine Live rha (PROQUAD) injection (product storage error) lot # R020678 and expiry date reported as 15-JAN-2020 (strength, dose # and route of administration were not reported) for prophylaxis which was reconstituted with properly stored sterile diluent. No adverse effects were reported. It was reported that, the vaccine underwent temperature excursion (32.57 Fahrenheit) 15 degree Fahrenheit to 46 degree Fahrenheit between the time frame of 22 hours. There were no previous temperature excursions. There was an involvement of digital data logger. There was no associated product quality complaint.
Age: 60.0
Sex: M
Vaccine: VARZOS
Symptoms: Herpes zoster, Hyperaesthesia, Pain, Rash
Clinical narrative: Started with sensitivity in the right lower leg on Thursday. Developed rash 2 d later. Started using OTC hydrocortisone without relief.  More pain in the last 2 d. Started with rash into the right gluteus. Advil did not help rash pain. More pain with sitting and contact to the area.  He received the first of 2 shingles vaccines the week before rash started.    Zoster w/out complications: This is the first visit for this problem.  Valacyclovir 1gram 1 tablet orally three times a day x 7 d was started.  Shingles (Herpes Zoster) handout was given.  Patient was given Drug Info Sheet today with medication change.  He is getting adequate pain control without multiple medications at this time.  We discussed additional options if needed.  I did opt to report this to VAERS Given the close proximity to the shingles outbreak with the shingles vaccine.
Age: 49.0
Sex: F
Vaccine: UNK
Symptoms: Amnesia, Dyspnoea, Mechanical ventilation, Paraesthesia, Paralysis
Clinical narrative: Patient's memory has been affected so does not recall exact dates.  Patient received vaccine at job site.   Date of vaccination around 2013 or 2014.  Patient had never received a vaccine--any-- prior to that date.  Approximately 8-12 months later started to have tingling in extremitiesarms and legs.  In 2015-2016 patient was in the city and woke up in hospital. The patient was in hospital for about 6 months and then moved into nursing home after that.   Doctor thought that it was GBS, that paralysis had gone to chest and had to be on ventilator because could not breathe on her on.   Current primary is Dr just changed doctors Scheduled to go for evaluation for progression to new doctor on 12/31/19, Neurology Dr
Age: 71.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site bruising, Pain in extremity, Rash, Skin warm
Clinical narrative: Patient presented to the pharmacy with a bruise at the injection site. The patient also had a rash below the injection site. The patient stated the arm was very sore and hot to touch.
Age: 49.0
Sex: F
Vaccine: FLU4
Symptoms: Full blood count, Headache, Injection site erythema, Injection site swelling, Nausea
Clinical narrative: Injection site red, swelling,  severe headaches, nausea, body aches.    body aches lasted 5 days or more. Doctor suspects Reiter's Syndrome
Age: 49.0
Sex: F
Vaccine: FLU4
Symptoms: Pain, Reiter's syndrome
Clinical narrative: Injection site red, swelling,  severe headaches, nausea, body aches.    body aches lasted 5 days or more. Doctor suspects Reiter's Syndrome
Age: 14.0
Sex: F
Vaccine: FLUC4
Symptoms: Injection site erythema, Injection site nodule, Injection site warmth
Clinical narrative: Large injection site reaction. Redness about 4 inches in diameter (about the size of an orange) including 1/2 inch raised knot under the skin. Skin was hot to the touch as well. Injection site did not hurt to touch according to the patient. The reaction remained about the same size all day on 10-29-19. Patient was instructed to apply ice for swelling. Patient took dose of benadryl and was instructed to use Tylenol or Ibuprofen if needed. By 10-30-19 at 8:50am the injection site was much better and by 10-31-19 at 12:27pm the redness was completely gone.
Age: 35.0
Sex: M
Vaccine: FLU4
Symptoms: Syncope
Clinical narrative: Patient received vaccination appropriately. Upon leaving the building approximately  min after the vaccine was given, the patient fainted near the front of the store in the vestibule. Pharmacy staff attended to him in the vestibule and contacted 911. The patient declined the EMT services. After approximately 10 minutes the patient felt better and left the store.
Age: 3.0
Sex: F
Vaccine: FLU4
Symptoms: Extensive swelling of vaccinated limb, Injection site inflammation
Clinical narrative: Significant swelling and inflammation to Left Thigh  Treated with Benadryl and Prednisolone
Age: 1.17
Sex: F
Vaccine: VARCEL
Symptoms: Injection site rash, Rash
Clinical narrative: Client was having spots on the arm that the varicella vaccine was given that were spreading to face and shoulder.
Age: 70.0
Sex: M
Vaccine: PPV
Symptoms: Injection site discomfort, Injection site erythema, Injection site pain, Injection site swelling, Injection site warmth
Clinical narrative: Lower half of right upper arm down through elbow area red, swollen, warm to touch, and very tender that started 11-19-19 - the day after injection; patient took Tylenol for discomfort; symptoms were subsiding by time reported to clinic on 11-21-19.
Age: 16.0
Sex: M
Vaccine: MENB
Symptoms: Palpitations, Tachycardia
Clinical narrative: Mom states that 2-3 days after the Vaccine was given the child developed Tachycardia and Palpitations. Parents took child for an evaluation by the Cardiologist and was advised that it was transient and his Cardiac evaluation was negative.
Age: 76.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site bruising, Injection site pain, Injection site rash, Pain, Pain in extremity
Clinical narrative: Bruise around injection site, pain in arm where immunization occurred, pain radiated down past elbow. Patient reported not being able to move her arm around without experiencing extreme pain. She took ibuprofen the evening of the immunization to help minimize symptoms. 1 week later there is a dime size bruise/rash at infection site that patient reports to still be painful
Age: 62.0
Sex: M
Vaccine: PNC13
Symptoms: Contusion, Hypoaesthesia, Injected limb mobility decreased, Injection site pain, Muscular weakness
Clinical narrative: Patient went to doctor's office for ongoing care for arthritis.  Within 2-3 days of vaccine, it affected left side. Started to feel weakness on left arm, it got numb, and then arm became unusable within 72 hours.  On Tuesday called doctor to report it and told to go to the ER if it gets worse. Patient called doctor's office every day through Friday. On Friday, arm turned purple and blew up like a balloon/eggplant, site painful and weakcould barely lift it.  On 8/24, patient went to ER and they were baffled with arm--suggested it could be a muscle tear.   Rheumatologist provided the referral to orthopedic doctor.   On 8/25 patient went to Dr. (orthopedist) did not do any testing but thought it was not a muscle tear but a neuropathic reaction to vaccine.  Doctor increased Prednisone dose but did not help much.  Patient has seen several specialists listed and regular doctorsee below.  Rheumatologist would have most complete record from all specialists.  Per the specialists, they could not prove it was not the vaccine.   After 3 weeks, swelling started to improve and bruising took 6 weeks.    Patient tapered off tapered Prednisone back to 10mg within 2 weeks.   Patient went to Dr. (neurologist) who helped him with care for the Flu vaccine adverse events.  Visually there is improvement on arm but pain and strength has not improved. Strength on arm is getting worse over time and cannot even straighten arm. Problems that occurred with Flu vaccine were ongoing.
Age: 62.0
Sex: M
Vaccine: PNC13
Symptoms: Neurological symptom, Peripheral swelling, Skin discolouration
Clinical narrative: Patient went to doctor's office for ongoing care for arthritis.  Within 2-3 days of vaccine, it affected left side. Started to feel weakness on left arm, it got numb, and then arm became unusable within 72 hours.  On Tuesday called doctor to report it and told to go to the ER if it gets worse. Patient called doctor's office every day through Friday. On Friday, arm turned purple and blew up like a balloon/eggplant, site painful and weakcould barely lift it.  On 8/24, patient went to ER and they were baffled with arm--suggested it could be a muscle tear.   Rheumatologist provided the referral to orthopedic doctor.   On 8/25 patient went to Dr. (orthopedist) did not do any testing but thought it was not a muscle tear but a neuropathic reaction to vaccine.  Doctor increased Prednisone dose but did not help much.  Patient has seen several specialists listed and regular doctorsee below.  Rheumatologist would have most complete record from all specialists.  Per the specialists, they could not prove it was not the vaccine.   After 3 weeks, swelling started to improve and bruising took 6 weeks.    Patient tapered off tapered Prednisone back to 10mg within 2 weeks.   Patient went to Dr. (neurologist) who helped him with care for the Flu vaccine adverse events.  Visually there is improvement on arm but pain and strength has not improved. Strength on arm is getting worse over time and cannot even straighten arm. Problems that occurred with Flu vaccine were ongoing.
Age: 58.0
Sex: F
Vaccine: VARCEL
Symptoms: Dyspnoea, Rash, Rash pruritic
Clinical narrative: Patient stated that she developed a itchy rash all over and had trouble breathing. She did not contact her PCP. She stated she took a Benadryl and used her Ventolin inhaler. She said she felt better the next day by the rash stayed for 2-3 more days.
Age: 13.0
Sex: F
Vaccine: FLU4
Symptoms: Dizziness, Muscle twitching, Syncope
Clinical narrative: Patient has a history of vasovagal syncope Received flu vaccine while laying on the exam table and felt dizzy Patient fainted for less than a second, legs and arms twitched and then she came to and stated, "I was on a road trip with hello kitty" Patient remained supine with a cool compress on her forehead and Dr was asked to come examine the patient  Dr came in to exam the patient at 3:25pm   Will repeat BP in 15 minutes after patient sits up Then recheck after 5 more minutes and see how patient feels
Age: 65.0
Sex: F
Vaccine: PPV
Symptoms: Inappropriate schedule of product administration
Clinical narrative: Pt received a dose of pneumovax 23 prior to the dose of prevnar 13 after 65 years old. (incorrect order of immunization.
Age: 73.0
Sex: F
Vaccine: VARZOS
Symptoms: Immediate post-injection reaction, Neuralgia
Clinical narrative: Patient says she feels like someone is stabbing her nerve endings 24/7.  She said it started immediately after receiving the vaccination and has not eased up.
Age: 28.0
Sex: F
Vaccine: TDAP
Symptoms: Nausea, Vomiting
Clinical narrative: Patient had nausea and vomiting after the shot.We offered to seek medical attention and patient refused and stated that she feel nausea before with another vaccine and felt better after some time. After  20 min she started feeling better and  went home.
Age: 52.0
Sex: M
Vaccine: VARZOS
Symptoms: Condition aggravated, Gout
Clinical narrative: Patient had first shingrix vaccine administered in the afternoon, and the next day woke up with a gouty attack in his right foot.
Age: 17.0
Sex: F
Vaccine: HEPA, IPV, TD
Symptoms: Syncope
Clinical narrative: Fainting episode; elevated lower extremeties, applied cool compress, VS checked and stable, resp even and unlabored. Pt responded to verbal stimuli @ 30-45 seconds after fainting. Pt given crackers, and hydrated with powerade.  Incident lasted from @12:04 to 12:08.Pt remained in clinic until 12:30pm. A & O x 3 steady stable gait upon ambulating out of clinic without assistance. Resp even and unlabored.
Age: 27.0
Sex: F
Vaccine: HEPAB, TD
Symptoms: Injection site erythema, Injection site pain, Injection site pruritus, Injection site swelling
Clinical narrative: Pt. presented with mild swelling and erythema, tenderness and itching to right deltoid at the Td administration site 2cm in diameter. Supportive tx with ice packs, OTC Tylenol and OTC Hydrocortisone cream 1% topically BID. S/s resolved with supportive care and resolved by 11/25/19.
Sex: U
Vaccine: RV5
Symptoms: Inappropriate schedule of product administration, No adverse event
Clinical narrative: The patient who is 4 months old was administered the first dose of ROTATEQ / beyond 12 weeks of age; No adverse effects reported; This spontaneous report was received from a registered nurse referring to a 4 month-old-patient of unknown gender. Patient's pertinent historical and current conditions, historical and concomitant medications, previous drugs reactions or allergies were not provided.  On 08-NOV-2019, the patient was vaccinated with rotavirus vaccine, live, oral, pentavalent (ROTATEQ) first dose, 2 milliliter, for prophylaxis (lot number S000954 has been verified to be a valid lot number, upon internal validation the expiration date was established as 17-OCT-2020). According with the reporter, the patient was vaccinated beyond the 12 weeks of age (product administered to patient of inappropriate age), no adverse effect was reported.
Age: 70.0
Sex: F
Vaccine: FLUA3, PPV
Symptoms: Extensive swelling of vaccinated limb, Injection site pain, Injection site swelling, Pain in extremity
Clinical narrative: SWELLING AND PAIN IN LEFT ARM. BEGINNING AT SITE OF SHOT AND SPREADING DOWN ARM OVER THE COURSE OF 48 HOURS. PT REPORTS SIGNIFICANT SWELLING
Age: 68.0
Sex: F
Vaccine: VARZOS, VARZOS, VARZOS, VARZOS
Symptoms: Fatigue, Herpes zoster, Rash, Rash pruritic
Clinical narrative: Shringles started 11/19/2019; small bumps itchy at first, then painful. Extremely tired. Prescribed Valacyclovir HCL 1  gm 3 x day; 7 days
Age: 68.0
Sex: F
Vaccine: VARZOS, VARZOS, VARZOS, VARZOS
Symptoms: Discomfort, Herpes zoster, Pain, Vaccination failure
Clinical narrative: Shringles started 11/19/2019; small bumps itchy at first, then painful. Extremely tired. Prescribed Valacyclovir HCL 1  gm 3 x day; 7 days