chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 53.0
Sex: M
Vaccine: VARZOS
Symptoms: Allodynia, C-reactive protein normal, Full blood count normal, Laboratory test normal, Red blood cell sedimentation rate normal
Clinical narrative: I developed allodynia  on the right side of my trunk from the axillae to the umbilicus front and back.  Symptoms did not cross the midline.  I self medicated with NSAIDs, no better.  I saw my internist on 8/29/19 and had labs, started prednisone 60 mg tapering by 10 mg over 6 days.  Symptoms much improved on steroids but not resolved.  As of today I am 5 days off steroids and my symptoms continue to improve gradually.
Age: 66.0
Sex: F
Vaccine: PPV
Symptoms: Chills, Erythema, Headache, Nausea, Pain
Clinical narrative: SHE SAID SHE PHONED ANOTHER PHARMACY THAT WAS OPENED AT 5:00 AM (09/08/19);  SHE COMPLAINED OF CHILLS, BODY ACHE, HEADACHE, NAUSEA, SWELLING, REDNESS
Age: 66.0
Sex: F
Vaccine: PPV
Symptoms: Swelling
Clinical narrative: SHE SAID SHE PHONED ANOTHER PHARMACY THAT WAS OPENED AT 5:00 AM (09/08/19);  SHE COMPLAINED OF CHILLS, BODY ACHE, HEADACHE, NAUSEA, SWELLING, REDNESS
Age: 63.0
Sex: F
Vaccine: VARZOS
Symptoms: Back pain, Decreased appetite, Hypersomnia, Pain, Pain in extremity
Clinical narrative: 1.) Arm began to hurt. Mild, about a 2-3. 2.) Then, extreme pain- of level 10 in lower left area of back- (below ribs, above hip ). Pain felt like a kick by boot, or a deep bruise caused by a car accident. Pain was localized.  No fever.  No vomiting. Lack of appitite. Unable to move without pain. I slept for 32 hours  ( First 24:hrs only drank water, used restroom). 3.) After 32 hours, pain remained at about a 5 level  for next 24 hours.  Able to eat small amount of food . No fever, no vomiting- just pain. 4.) Dull pain (2 level) in lower back at site on left side continues after 6 days.
Age: 70.0
Sex: M
Vaccine: VARZOS
Symptoms: Pruritus
Clinical narrative: Pt states neck/arm/ back have been itching since getting injection.
Age: 13.0
Sex: F
Vaccine: HEPA
Symptoms: Balance disorder, Blepharitis, Blood test normal, Chest discomfort, Chest pain
Clinical narrative: Started within  the first 36 hours  Body twitches Fatigue Headache Arm thumbless Chest pain and tightness  Shortness of breath  Balance problems Eyelid inflammation and eye pain
Age: 13.0
Sex: F
Vaccine: HEPA
Symptoms: Dyspnoea, Electrocardiogram normal, Electroencephalogram normal, Eye pain, Fatigue
Clinical narrative: Started within  the first 36 hours  Body twitches Fatigue Headache Arm thumbless Chest pain and tightness  Shortness of breath  Balance problems Eyelid inflammation and eye pain
Age: 13.0
Sex: F
Vaccine: HEPA
Symptoms: Headache, Muscle twitching
Clinical narrative: Started within  the first 36 hours  Body twitches Fatigue Headache Arm thumbless Chest pain and tightness  Shortness of breath  Balance problems Eyelid inflammation and eye pain
Age: 6.0
Sex: F
Vaccine: DTAPHEPBIP, MMR, VARCEL
Symptoms: Fall, Head injury, Seizure
Clinical narrative: A few minutes after vaccination the child fell, hit her head on the floor and had a seizure lasting less than 1 minute.  The child then sat up and climbed into her father's lap, BP 120/70 left arm, child alert and oriented, father was offered emergency treatment/assessment of child through 911 but father declined.  Encouraged father to bring the child to facility for assessment, father stated he would do that.  Child ambulated out of the office independently, accompanied by her father.
Age: 70.0
Sex: F
Vaccine: VARZOS
Symptoms: Pruritus
Clinical narrative: Pt states itchy arm/neck/back since receiving the shingrix vaccination.
Age: 0.58
Sex: F
Vaccine: RV5
Symptoms: Diarrhoea, Haematochezia, Mucous stools, Ultrasound abdomen normal
Clinical narrative: Diarrhea with 2 episodes of small amount of blood with mucus in stool started the evening after vaccine was given. Continues with diarrhea about 5 episodes of loose watery stool today(the day after vaccine is given).
Age: 66.0
Sex: M
Vaccine: FLU3, PPV
Symptoms: Erythema, Peripheral swelling
Clinical narrative: patient started noticing swelling on his arm that spread down to about his elbow, starting yesterday. he woke up and it was more red, but he hadn't noticed it getting any worse since he woke up. patient states he had no other symptoms except the swelling but found it unusual since he has had shots before and no problems. he has had a flu shot last year with no problem and the prevnar13. this year he received the flu shot and pneumovax 23 when it occurred. he  just wanted to let us know and said he would keep an eye on it and let us know if it got worse or if he wanted to go get it looked at or etc.
Age: 5.0
Sex: M
Vaccine: DTAPIPV, VARCEL
Symptoms: Asthenia, Decreased appetite, Pyrexia, Vomiting
Clinical narrative: Fever x3days - Tmax 105.3-started evening of vaccination. emesis x2 day of vaccine. poor appetite x2 days very low energy x3days
Age: 11.0
Sex: M
Vaccine: MNQ
Symptoms: Fatigue, Injection site erythema, Injection site induration, Malaise, Nausea
Clinical narrative: Pt received Menveo on 9/3/19. That evening he complained of not feeling well, @ nausea, fatigue. Slept ~ 14 hrs. Today without symptoms however site of injection is red & indurated 8x9 cm in size.
Age: 38.0
Sex: F
Vaccine: HEP
Symptoms: Dizziness, Hypoaesthesia, Malaise, Palpitations, Product administered at inappropriate site
Clinical narrative: The nurse did the shot to heard and went up to high on my right arm She hit the bone my shoulder still ant the same my hand keeps going numb I got sick from the shot I had lightheadness, dizzens, heart racing,
Age: 82.0
Sex: F
Vaccine: VARZOS
Symptoms: Mobility decreased, Pain in extremity
Clinical narrative: VERY SORE ARM - COULD HARDLY MOVE IT VERY PAINFUL iF I HAD TO USE iT WAS LiKE THAT FOR A COUPE DAYS THEN PAiN LESSENED, BUT WAS SORE FOR ABOUT A WEEK
Age: 5.0
Sex: M
Vaccine: FLU4, FLU4
Symptoms: Crying, Disorientation, Emotional distress, Musculoskeletal stiffness, Screaming
Clinical narrative: (Reported to nurse by parent via phone) Pt was emotional and cried at school 9/9/19 afternoon. Woke suddenly at 10:30 pm screaming, crying, shaking. Body went stiff the patient urinated on self. Episode lased approximately 2 minutes, but patient Remained disoriented an additional 8 mins. Pt then went to sleep, no further incidents Remainder of the night. Pt awoke 9/10/19 a.m. at normal time, acting normally, no recollection of event.
Age: 5.0
Sex: M
Vaccine: FLU4, FLU4
Symptoms: Tremor, Urinary incontinence
Clinical narrative: (Reported to nurse by parent via phone) Pt was emotional and cried at school 9/9/19 afternoon. Woke suddenly at 10:30 pm screaming, crying, shaking. Body went stiff the patient urinated on self. Episode lased approximately 2 minutes, but patient Remained disoriented an additional 8 mins. Pt then went to sleep, no further incidents Remainder of the night. Pt awoke 9/10/19 a.m. at normal time, acting normally, no recollection of event.
Age: 5.0
Sex: M
Vaccine: FLU4, FLU4
Symptoms: Amnesia, Crying, Disorientation, Musculoskeletal stiffness, Screaming
Clinical narrative: (Reported to nurse by parent via phone) Pt was emotional and cried at school 9/9/19 afternoon. Woke suddenly at 10:30 pm screaming, crying, shaking. Body went stiff the patient urinated on self. Episode lased approximately 2 minutes, but patient Remained disoriented an additional 8 mins. Pt then went to sleep, no further incidents Remainder of the night. Pt awoke 9/10/19 a.m. at normal time, acting normally, no recollection of event.
Age: 5.0
Sex: M
Vaccine: FLU4, FLU4
Symptoms: Urinary incontinence
Clinical narrative: (Reported to nurse by parent via phone) Pt was emotional and cried at school 9/9/19 afternoon. Woke suddenly at 10:30 pm screaming, crying, shaking. Body went stiff the patient urinated on self. Episode lased approximately 2 minutes, but patient Remained disoriented an additional 8 mins. Pt then went to sleep, no further incidents Remainder of the night. Pt awoke 9/10/19 a.m. at normal time, acting normally, no recollection of event.
Age: 76.0
Sex: M
Vaccine: VARZOS
Symptoms: Chills, Lethargy, Pyrexia, Somnolence, Tremor
Clinical narrative: Chills, shaking, Fever 101.1 Lethargic, drowsy
Age: 17.0
Sex: F
Vaccine: MMR
Symptoms: Dermatitis contact, Drug eruption, Idiopathic urticaria, Rash, Rash pruritic
Clinical narrative: 1) Patient Received vaccine MMR on 8/21/19 seen @ office 8/23/19 with itchy rash urticaria on trunk. Initially 50mg Benadryl taken 2) Patient referred to allergy specialist & seen within 4 hours. Dx skin rash drug eruption vs allergic contact dermatitis vs idiopathic urticaria. Per allergist dx skin rash - drug eruption vs allergic contact dermatitis vs idiopathic urticaria. To start Zyrtec or Xyzal one pill BID until Rash & itching controlled - then once a day. Also Prednisone taper 30mg day one, 20 mg BID & taper down over 8 days. May need skin Bx if no improved. To follow up @1 week - Patient has not returned for follow up.
Age: 17.0
Sex: F
Vaccine: MMR
Symptoms: Urticaria
Clinical narrative: 1) Patient Received vaccine MMR on 8/21/19 seen @ office 8/23/19 with itchy rash urticaria on trunk. Initially 50mg Benadryl taken 2) Patient referred to allergy specialist & seen within 4 hours. Dx skin rash drug eruption vs allergic contact dermatitis vs idiopathic urticaria. Per allergist dx skin rash - drug eruption vs allergic contact dermatitis vs idiopathic urticaria. To start Zyrtec or Xyzal one pill BID until Rash & itching controlled - then once a day. Also Prednisone taper 30mg day one, 20 mg BID & taper down over 8 days. May need skin Bx if no improved. To follow up @1 week - Patient has not returned for follow up.
Sex: F
Vaccine: VARZOS
Symptoms: Deafness, Vertigo
Clinical narrative: hearing loss; vertigo; Information has been received from a lawyer and the patient regarding a case in litigation concerning a female patient (age unknown). The patient's medical history, concurrent conditions and concomitant medication use were not provided.  On or about 26-SEP-2017, the patient (pt) was vaccinated with zoster vaccine live (ZOSTAVAX), (lot# and route unknown) for routine health maintenance and for its intended purpose: the prevention of shingles (herpes zoster). Shortly after  zoster vaccine live (ZOSTAVAX) vaccination, the pt suffered hearing loss and vertigo (dates unspecified).   As a direct and proximate result of zoster vaccine live (ZOSTAVAX), the pt's symptoms have resulted in physical limitations not present prior to using the product. The pt also experienced mental and emotional distress due to resulting physical limitations and seriousness of her condition. As a result of zoster vaccine live (ZOSTAVAX), the patient sustained severe and permanent personal injuries. Further, as a tragic consequence of the 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 the Company's conduct, the patient has suffered and incurred damages, including medical expenses; the loss of accumulations; and other economic and non-economic damages. The outcome of the events were considered not resolved. The events were considered related to zoster vaccine live (ZOSTAVAX).  Hearing loss and vertigo were considered to be disabling events. Upon internal review, the event hearing loss was determined to be medically significant.
Sex: F
Vaccine: HPV9
Symptoms: Syncope
Clinical narrative: patient "fainted" after receiving the first dose in the GARDASIL 9 series; Information has been received from a nurse via an employee referring to a 12 years old female patient. The patient was not pregnant. The patient's concomitant medications, pertinent medical history and drug reactions/allergies were unknown by the reporter.  On an unspecified date, the patient was vaccinated with the first dose HPV rL1 6 11 16 18 31 33 45 52 58 VLP vaccine (yeast) (GARDASIL 9) (frequency, anatomical location, route of administration, lot number and expiration date were unknown) for prophylaxis (reported as cervical cancer prevention) and the patient fainted after receiving vaccination.   No product quality complaint (PQC) was involved. Information about treatment given for adverse event, lab diagnostics/studies performed and medical attention was unknown by the reporter. The outcome of the event was reported as recovered. The causality between the event and HPV rL1 6 11 16 18 31 33 45 52 58 VLP vaccine (yeast) (GARDASIL 9) therapy was not provided.  Upon internal review, the event of faint was determined to be medically significant.
Age: 4.0
Sex: U
Vaccine: VARCEL
Symptoms: No adverse event, Product storage error
Clinical narrative: no adverse effect; improperly stored VARIVAX; This spontaneous report was received from a registered nurse referring to a 4-year-old patient of unknown gender. No information was provided regarding the patient's medical history, concurrent conditions or concomitant medications.  On 12-AUG-2019 and 13-AUG-2019, vaccines had a temperature excursion.  On 30-AUG-2019, the patient was vaccinated with varicella virus vaccine live (oka/merck) (VARIVAX) lot # R006221 with expiration date on 29-FEB-2020 or R029517 with expiration date on 10-OCT-2020 (dosage schedule, route and anatomical location were not reported), for prophylaxis (incorrect product storage).  Administered doses of vaccine experienced temperature excursion of -14 degrees Celsius (C) to -10 C (-11.91 C) for 8 hours. There was no previous temperature excursion. Digital data logger was involved. Vaccines were reconstituted with a properly stored sterile diluent. No adverse effects were reported.
Age: 5.0
Sex: U
Vaccine: VARCEL
Symptoms: No adverse event, Product storage error
Clinical narrative: no adverse effect reported; improperly stored VARIVAX; This spontaneous report was received from a registered nurse referring to a 5-year-old patient of unknown gender. No information was provided regarding the patient's medical history, concurrent conditions or concomitant medications.  On 12-AUG-2019 and 13-AUG-2019, vaccines had a temperature excursion.  On 30-AUG-2019, the patient was vaccinated with varicella virus vaccine live (oka/merck) (VARIVAX) lot # R006221 with expiration date on 29-FEB-2020 or R029517 with expiration date on 14-OCT-2020 (dosage schedule, route and anatomical location were not reported), for prophylaxis (incorrect product storage).  Administered doses of vaccine experienced temperature excursion of -14 degrees Celsius (C) to -10 C (-11.91 C) for 8 hours. There was no previous temperature excursion. Digital data logger was involved. Vaccines were reconstituted with a properly stored sterile diluent. No adverse effects were reported.
Sex: U
Vaccine: HEPA
Symptoms: Expired product administered, No adverse event
Clinical narrative: No adverse effects; One expired dose of VAQTA was inadvertently administered to a patient on 9/9/2019; This spontaneous report was received from a nurse concerning to a patient of unknown age and gender. Information regarding the patient's medical history, concurrent conditions and concomitant medications was not reported.       On 09-SEP-2019, one expired dose of hepatitis a vaccine, inactivated (VAQTA) was inadvertently vaccinated to a patient (expired product administered) 0.5 milliliter, for prophylaxis (lot # R021233 has been verified to be a valid lot number for hepatitis a vaccine, inactivated; expiration date reported and establish as 05-SEP-2019) (strength and route of administration were not reported).       No adverse effects reported.
Age: 33.0
Sex: F
Vaccine: FLU4
Symptoms: Incorrect route of product administration, Nausea, Systemic inflammatory response syndrome, Vomiting, White blood cell count increased
Clinical narrative: SIRS; Administered flu vaccine intravenously; This is a spontaneous case, initially received from pharmacist via Agency (reference number: SEQ19-02270) on 04-Sep-2019, concerning a 33-year-old female patient.  The patient's medical history included chest pain, symptomatic anaemia and viral gastroenteritis.  The patient's concomitant medications included ferrous sulphate, amitriptyline, Duoneb (ipratropium bromide, albuterol sulfate), Zofran (ondansetron), Percocet (oxycodone, acetaminophen), oxycodone, Miralax (polyethylene glycol 3350) and senna; all for unknown indication.  On 11-Jan-2019, while was in hospital due to chest pain related to anemia, the patient was administered intravenously Afluria Quadrivalent [influenza vaccine, dose: 0.5 ml, batch number: YG40008, expiration date and anatomical location not reported] (explicitly coded as Inappropriate route of vaccination') for influenza prophylaxis. On the same day, the patient was discharged home.  On 12-Jan-2019, one day after vaccination, the patient developed nausea and vomiting with elevated white blood cell count. The patient was readmitted to hospital and diagnosed with Systemic inflammatory response syndrome (SIRS).  On 15-Jan-2019, the event of SIRS was resolved.  It was unknown if the event of SIRS was caused by IV administration of influenza vaccine or from viral gastroenteritis.  The reporter assessed the case as serious.  Company Comment: The patient experienced systemic inflammatory response syndrome after incorrect route of the suspect product Afluria Quadrivalent administration (reported as flu vaccine intravenously administered). Chronology is plausible. Medical history of anaemia and viral gastroenteritis may have contributed to development of the event systemic inflammatory response syndrome. Causality was also confounded by therapy with multiple concomitant medications. Considering all the above mentioned, causal relationship between the suspect product and the event systemic inflammatory response syndrome is assessed as related and as not related for incorrect route of product administration.; Reporter's Comments: The patient experienced systemic inflammatory response syndrome after incorrect route of the suspect product Afluria Quadrivalent administration (reported as flu vaccine intravenously administered). Chronology is plausible. Medical history of anaemia and viral gastroenteritis may have contributed to development of the event systemic inflammatory response syndrome. Causality was also confounded by therapy with multiple concomitant medications. Considering all the above mentioned, causal relationship between the suspect product and the event systemic inflammatory response syndrome is assessed as related and as not related for incorrect route of product administration.
Age: 0.08
Sex: F
Vaccine: DTAPHEPBIP, HIBV, PNC13, RV1
Symptoms: Haematochezia, Mucous stools, Occult blood positive
Clinical narrative: 9/10/19 - 65 day old female with blood in stools for 2 days. Parents report 3-4 diapers with small amount blood, some mucus. Pt is awake, alert & happy. No other symptoms noted. Plan is to start alimentun for 2 month, probiotics & monitor
Age: 69.0
Sex: F
Vaccine: FLU3, PPV
Symptoms: Cellulitis, Erythema, Pain in extremity, Peripheral swelling, Pyrexia
Clinical narrative: Patient returned to pharmacy on 9/10 stating that she was diagnosed with cellulitis in the injection arm (this was per physician). Upon examination, arm appeared red and swollen.  Patient states that she was experiencing pain in the arm and that she was feverish.  Patient received prescriptions for methylprednisolone dose pack and amoxicillin-clav antibiotic.
Age: 62.0
Sex: F
Vaccine: PPV, VARZOS
Symptoms: Vaccination site pain, Vaccination site swelling, Vaccination site warmth
Clinical narrative: Patient reported intitially on 09-08-19 that she had a lot of pain/swelling on the "inside" of the arm where she had the vaccinations. She also reported the area was hot to the touch. When questioned if it was on the outside of the arm where the needle went in she said,"no, on the inside of the arm"  She called back later stating that she sees the issue on the outside of the arm, as well.
Age: 53.0
Sex: F
Vaccine: TDAP
Symptoms: Incorrect route of product administration, Pyrexia
Clinical narrative: FEVER 102.9F (PT WAS ACCIDENTALLY GIVEN THE VACCINE INTRAVENOUSLY)
Age: 0.75
Sex: M
Vaccine: PNC13
Symptoms: Abnormal behaviour, Adenoidal hypertrophy, Adenoidectomy, Adenoiditis, Aphasia
Clinical narrative: 8/10/17 - 10 months - Vaccine reaction to prevnar 13 3rd dose- fever of 102, high pitched crying for over a week, especially at night, lost all sounds, became non verbal, lost eye contact, would not respond appropriately to stimuli.  1/24/18 - 15 months - Complained to Dr. about his ?regression? with sounds and speech. Said it happened after his last immunization and he never regained his sounds.  4/23/18 - 18 months - Complained to Dr. about his limited eating. He ate everything up until recently and was self limiting to about 5 foods at this time. Asked about getting speech therapy. Was told he still had time to catch up. But I pressed her because he was making NO SOUNDS anymore. She referred him for an Speech evaluation.  5/14/18 - 19 months- Evaluated for speech, scored at a 10month old level.  5/16/18 - 19 months - TDAP vaccine 3rd dose, stopped eating all foods but quinoa and almond milk post vaccination. Became chronically constipated. 6/1/18 - 20 months - Began speech therapy.  6/4/2018 - Appoint with MD, ENT- Concerns about speech, hearing and swallowing. Had Audiometric test. Tympanograms normal, Type A bilaterally. Diagnosed with Dysphagia.  7/10/18 - 21 months - Meeting with Early Intervention System. Had a 25% deficit an was approved for Early intervention services. In home speech and OT once a month. 10/1/2018- MD, ENT- Follow up for issues with related to Dysphagia, performed Laryngoscopy. Enlarged inflamed adenoidal tissue. Referred to Pediatric Gastroenterologist.  10/30/2018 24 months - Upper and Lower Frenectomy Laser Revision 11/21/2018-  MD, ENT Six week follow up.  11/28/18 - 25 months - MD - Upper GI Endoscopy - Diagnosed with Reflux Esophagitis, prescibled 40mg of Nexium 12/6/2018 - MD - Sleep Study Consult  12/17/18 - 26 months - Evaluated for Occupational Therapy. Scored 15months on grasping and 21months on visual motor integration. Started weekly OT.  1/9/2019 - Failed Sleep Study. 1/30/2019 -  MD, ENT - Follow up. Discuss and schedule adenoidectomy and tympanostomy tubes. 2/8/19 - 28 months - MD, ENT-  adenoidectomy and tympanostomy tubes. 2/23/19 - 28 months -  Implemented Cod Liver Oil- Significant improve in eye contact and speech and overall behavior 2/27/2019 - MD- GI Post op follow up. Instructed to do milk and molasses enemas for constipation. Prescribed Generlac.  3/21/2019 -MD, ENT- Post op follow up. Audiometric test. 5/16/19 - 30 months -  Extensive Labs done, high thyroid, low iron, high urea  9/4/2019 -  Evaluated at School for integration into school systems Special Needs program out of early intervention.
Age: 0.75
Sex: M
Vaccine: PNC13
Symptoms: Audiogram, Blood iron decreased, Blood urea increased, Constipation, Decreased eye contact
Clinical narrative: 8/10/17 - 10 months - Vaccine reaction to prevnar 13 3rd dose- fever of 102, high pitched crying for over a week, especially at night, lost all sounds, became non verbal, lost eye contact, would not respond appropriately to stimuli.  1/24/18 - 15 months - Complained to Dr. about his ?regression? with sounds and speech. Said it happened after his last immunization and he never regained his sounds.  4/23/18 - 18 months - Complained to Dr. about his limited eating. He ate everything up until recently and was self limiting to about 5 foods at this time. Asked about getting speech therapy. Was told he still had time to catch up. But I pressed her because he was making NO SOUNDS anymore. She referred him for an Speech evaluation.  5/14/18 - 19 months- Evaluated for speech, scored at a 10month old level.  5/16/18 - 19 months - TDAP vaccine 3rd dose, stopped eating all foods but quinoa and almond milk post vaccination. Became chronically constipated. 6/1/18 - 20 months - Began speech therapy.  6/4/2018 - Appoint with MD, ENT- Concerns about speech, hearing and swallowing. Had Audiometric test. Tympanograms normal, Type A bilaterally. Diagnosed with Dysphagia.  7/10/18 - 21 months - Meeting with Early Intervention System. Had a 25% deficit an was approved for Early intervention services. In home speech and OT once a month. 10/1/2018- MD, ENT- Follow up for issues with related to Dysphagia, performed Laryngoscopy. Enlarged inflamed adenoidal tissue. Referred to Pediatric Gastroenterologist.  10/30/2018 24 months - Upper and Lower Frenectomy Laser Revision 11/21/2018-  MD, ENT Six week follow up.  11/28/18 - 25 months - MD - Upper GI Endoscopy - Diagnosed with Reflux Esophagitis, prescibled 40mg of Nexium 12/6/2018 - MD - Sleep Study Consult  12/17/18 - 26 months - Evaluated for Occupational Therapy. Scored 15months on grasping and 21months on visual motor integration. Started weekly OT.  1/9/2019 - Failed Sleep Study. 1/30/2019 -  MD, ENT - Follow up. Discuss and schedule adenoidectomy and tympanostomy tubes. 2/8/19 - 28 months - MD, ENT-  adenoidectomy and tympanostomy tubes. 2/23/19 - 28 months -  Implemented Cod Liver Oil- Significant improve in eye contact and speech and overall behavior 2/27/2019 - MD- GI Post op follow up. Instructed to do milk and molasses enemas for constipation. Prescribed Generlac.  3/21/2019 -MD, ENT- Post op follow up. Audiometric test. 5/16/19 - 30 months -  Extensive Labs done, high thyroid, low iron, high urea  9/4/2019 -  Evaluated at School for integration into school systems Special Needs program out of early intervention.
Age: 0.75
Sex: M
Vaccine: PNC13
Symptoms: Developmental regression, Dysphagia, Ear tube insertion, Eating disorder, Endoscopy upper gastrointestinal tract abnormal
Clinical narrative: 8/10/17 - 10 months - Vaccine reaction to prevnar 13 3rd dose- fever of 102, high pitched crying for over a week, especially at night, lost all sounds, became non verbal, lost eye contact, would not respond appropriately to stimuli.  1/24/18 - 15 months - Complained to Dr. about his ?regression? with sounds and speech. Said it happened after his last immunization and he never regained his sounds.  4/23/18 - 18 months - Complained to Dr. about his limited eating. He ate everything up until recently and was self limiting to about 5 foods at this time. Asked about getting speech therapy. Was told he still had time to catch up. But I pressed her because he was making NO SOUNDS anymore. She referred him for an Speech evaluation.  5/14/18 - 19 months- Evaluated for speech, scored at a 10month old level.  5/16/18 - 19 months - TDAP vaccine 3rd dose, stopped eating all foods but quinoa and almond milk post vaccination. Became chronically constipated. 6/1/18 - 20 months - Began speech therapy.  6/4/2018 - Appoint with MD, ENT- Concerns about speech, hearing and swallowing. Had Audiometric test. Tympanograms normal, Type A bilaterally. Diagnosed with Dysphagia.  7/10/18 - 21 months - Meeting with Early Intervention System. Had a 25% deficit an was approved for Early intervention services. In home speech and OT once a month. 10/1/2018- MD, ENT- Follow up for issues with related to Dysphagia, performed Laryngoscopy. Enlarged inflamed adenoidal tissue. Referred to Pediatric Gastroenterologist.  10/30/2018 24 months - Upper and Lower Frenectomy Laser Revision 11/21/2018-  MD, ENT Six week follow up.  11/28/18 - 25 months - MD - Upper GI Endoscopy - Diagnosed with Reflux Esophagitis, prescibled 40mg of Nexium 12/6/2018 - MD - Sleep Study Consult  12/17/18 - 26 months - Evaluated for Occupational Therapy. Scored 15months on grasping and 21months on visual motor integration. Started weekly OT.  1/9/2019 - Failed Sleep Study. 1/30/2019 -  MD, ENT - Follow up. Discuss and schedule adenoidectomy and tympanostomy tubes. 2/8/19 - 28 months - MD, ENT-  adenoidectomy and tympanostomy tubes. 2/23/19 - 28 months -  Implemented Cod Liver Oil- Significant improve in eye contact and speech and overall behavior 2/27/2019 - MD- GI Post op follow up. Instructed to do milk and molasses enemas for constipation. Prescribed Generlac.  3/21/2019 -MD, ENT- Post op follow up. Audiometric test. 5/16/19 - 30 months -  Extensive Labs done, high thyroid, low iron, high urea  9/4/2019 -  Evaluated at School for integration into school systems Special Needs program out of early intervention.
Age: 0.75
Sex: M
Vaccine: PNC13
Symptoms: Gastrooesophageal reflux disease, High-pitched crying, Laryngoscopy abnormal, Pyrexia, Sleep study abnormal
Clinical narrative: 8/10/17 - 10 months - Vaccine reaction to prevnar 13 3rd dose- fever of 102, high pitched crying for over a week, especially at night, lost all sounds, became non verbal, lost eye contact, would not respond appropriately to stimuli.  1/24/18 - 15 months - Complained to Dr. about his ?regression? with sounds and speech. Said it happened after his last immunization and he never regained his sounds.  4/23/18 - 18 months - Complained to Dr. about his limited eating. He ate everything up until recently and was self limiting to about 5 foods at this time. Asked about getting speech therapy. Was told he still had time to catch up. But I pressed her because he was making NO SOUNDS anymore. She referred him for an Speech evaluation.  5/14/18 - 19 months- Evaluated for speech, scored at a 10month old level.  5/16/18 - 19 months - TDAP vaccine 3rd dose, stopped eating all foods but quinoa and almond milk post vaccination. Became chronically constipated. 6/1/18 - 20 months - Began speech therapy.  6/4/2018 - Appoint with MD, ENT- Concerns about speech, hearing and swallowing. Had Audiometric test. Tympanograms normal, Type A bilaterally. Diagnosed with Dysphagia.  7/10/18 - 21 months - Meeting with Early Intervention System. Had a 25% deficit an was approved for Early intervention services. In home speech and OT once a month. 10/1/2018- MD, ENT- Follow up for issues with related to Dysphagia, performed Laryngoscopy. Enlarged inflamed adenoidal tissue. Referred to Pediatric Gastroenterologist.  10/30/2018 24 months - Upper and Lower Frenectomy Laser Revision 11/21/2018-  MD, ENT Six week follow up.  11/28/18 - 25 months - MD - Upper GI Endoscopy - Diagnosed with Reflux Esophagitis, prescibled 40mg of Nexium 12/6/2018 - MD - Sleep Study Consult  12/17/18 - 26 months - Evaluated for Occupational Therapy. Scored 15months on grasping and 21months on visual motor integration. Started weekly OT.  1/9/2019 - Failed Sleep Study. 1/30/2019 -  MD, ENT - Follow up. Discuss and schedule adenoidectomy and tympanostomy tubes. 2/8/19 - 28 months - MD, ENT-  adenoidectomy and tympanostomy tubes. 2/23/19 - 28 months -  Implemented Cod Liver Oil- Significant improve in eye contact and speech and overall behavior 2/27/2019 - MD- GI Post op follow up. Instructed to do milk and molasses enemas for constipation. Prescribed Generlac.  3/21/2019 -MD, ENT- Post op follow up. Audiometric test. 5/16/19 - 30 months -  Extensive Labs done, high thyroid, low iron, high urea  9/4/2019 -  Evaluated at School for integration into school systems Special Needs program out of early intervention.
Age: 0.75
Sex: M
Vaccine: PNC13
Symptoms: Thyroid function test abnormal, Tympanometry normal
Clinical narrative: 8/10/17 - 10 months - Vaccine reaction to prevnar 13 3rd dose- fever of 102, high pitched crying for over a week, especially at night, lost all sounds, became non verbal, lost eye contact, would not respond appropriately to stimuli.  1/24/18 - 15 months - Complained to Dr. about his ?regression? with sounds and speech. Said it happened after his last immunization and he never regained his sounds.  4/23/18 - 18 months - Complained to Dr. about his limited eating. He ate everything up until recently and was self limiting to about 5 foods at this time. Asked about getting speech therapy. Was told he still had time to catch up. But I pressed her because he was making NO SOUNDS anymore. She referred him for an Speech evaluation.  5/14/18 - 19 months- Evaluated for speech, scored at a 10month old level.  5/16/18 - 19 months - TDAP vaccine 3rd dose, stopped eating all foods but quinoa and almond milk post vaccination. Became chronically constipated. 6/1/18 - 20 months - Began speech therapy.  6/4/2018 - Appoint with MD, ENT- Concerns about speech, hearing and swallowing. Had Audiometric test. Tympanograms normal, Type A bilaterally. Diagnosed with Dysphagia.  7/10/18 - 21 months - Meeting with Early Intervention System. Had a 25% deficit an was approved for Early intervention services. In home speech and OT once a month. 10/1/2018- MD, ENT- Follow up for issues with related to Dysphagia, performed Laryngoscopy. Enlarged inflamed adenoidal tissue. Referred to Pediatric Gastroenterologist.  10/30/2018 24 months - Upper and Lower Frenectomy Laser Revision 11/21/2018-  MD, ENT Six week follow up.  11/28/18 - 25 months - MD - Upper GI Endoscopy - Diagnosed with Reflux Esophagitis, prescibled 40mg of Nexium 12/6/2018 - MD - Sleep Study Consult  12/17/18 - 26 months - Evaluated for Occupational Therapy. Scored 15months on grasping and 21months on visual motor integration. Started weekly OT.  1/9/2019 - Failed Sleep Study. 1/30/2019 -  MD, ENT - Follow up. Discuss and schedule adenoidectomy and tympanostomy tubes. 2/8/19 - 28 months - MD, ENT-  adenoidectomy and tympanostomy tubes. 2/23/19 - 28 months -  Implemented Cod Liver Oil- Significant improve in eye contact and speech and overall behavior 2/27/2019 - MD- GI Post op follow up. Instructed to do milk and molasses enemas for constipation. Prescribed Generlac.  3/21/2019 -MD, ENT- Post op follow up. Audiometric test. 5/16/19 - 30 months -  Extensive Labs done, high thyroid, low iron, high urea  9/4/2019 -  Evaluated at School for integration into school systems Special Needs program out of early intervention.
Age: 5.0
Sex: F
Vaccine: MMRV, VARCEL
Symptoms: Extra dose administered
Clinical narrative: An MMRV was given along with a Varicella.
Age: 4.0
Sex: M
Vaccine: MMRV, VARCEL
Symptoms: Extra dose administered
Clinical narrative: Varicella vaccine was given with an MMRV vaccine.
Age: 73.0
Sex: F
Vaccine: VARZOS
Symptoms: Arthralgia, Asthenia, Chills, Fatigue, Headache
Clinical narrative: Pain, bruising and swelling at injection site. General muscle pain, tiredness, weakness, headache, shivering, fever, nausea, joint pain.
Age: 73.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site bruising, Injection site pain, Injection site swelling, Myalgia, Nausea
Clinical narrative: Pain, bruising and swelling at injection site. General muscle pain, tiredness, weakness, headache, shivering, fever, nausea, joint pain.
Age: 73.0
Sex: F
Vaccine: VARZOS
Symptoms: Pyrexia
Clinical narrative: Pain, bruising and swelling at injection site. General muscle pain, tiredness, weakness, headache, shivering, fever, nausea, joint pain.
Age: 5.0
Sex: F
Vaccine: MMRV, VARCEL
Symptoms: Extra dose administered
Clinical narrative: A Varicella vaccine was given at the same time as an MMRV vaccine.
Age: 67.0
Sex: F
Vaccine: FLU3
Symptoms: Injection site erythema, Injection site swelling, Injection site warmth
Clinical narrative: patient developed a red, swollen and warm arm from the mid deltoid down to the elbow in the left arm starting the day after receiving the vaccine.  She eventually saw a doctor and they recommended she take benadryl which she has started yesterday 9/9 and it has been improving since.
Age: 17.0
Sex: F
Vaccine: MENB
Symptoms: Chills, Hypoaesthesia, Injected limb mobility decreased, Muscular weakness, Nervousness
Clinical narrative: Patient received her second Meningococcal B (Bexero) vaccine today, 9/10/19, at 8:20 am.   The first dose was given on 7/30/19. The vaccine was given properly in the left deltoid after the patient passed the nursing protocol for administration.  When patient left, she was feeling well and had no complaints.  Her mother called our nurse triage line at 11:05 am stating that she was having left arm pain, numbness and weakness and that she was unable to make a fist or raise her arm above her head.  She arrived to our clinic at 12:45 to be seen by a provider.  She was having chills, left arm pain 6/10 and generalized body aches/pain 8/10 and felt shaky. Her vitals were as follows: temperature 39 degrees Celsius, blood pressures were 72/38 initially and then 90/38, pulse 89, and 99% oxygen saturation.  The patient was given something to eat as she had only a small breakfast and no lunch.  After further discussion with the provider, the mother stated that the symptoms started an hour and a half after she received the vaccine.  There was no swelling, redness or warmth at the injection site.  Patient?s repeat blood pressure thirty minutes later was 98/61 and pulse was 89, she was not flush-appearing and was starting to feel better.  The arm weakness had improved prior to being seen in clinic, and was completely resolved prior to her leaving the clinic.  She was observed for over an hour in clinic and was sent home with instructions to return should symptoms reappear.
Age: 17.0
Sex: F
Vaccine: MENB
Symptoms: Pain, Pain in extremity
Clinical narrative: Patient received her second Meningococcal B (Bexero) vaccine today, 9/10/19, at 8:20 am.   The first dose was given on 7/30/19. The vaccine was given properly in the left deltoid after the patient passed the nursing protocol for administration.  When patient left, she was feeling well and had no complaints.  Her mother called our nurse triage line at 11:05 am stating that she was having left arm pain, numbness and weakness and that she was unable to make a fist or raise her arm above her head.  She arrived to our clinic at 12:45 to be seen by a provider.  She was having chills, left arm pain 6/10 and generalized body aches/pain 8/10 and felt shaky. Her vitals were as follows: temperature 39 degrees Celsius, blood pressures were 72/38 initially and then 90/38, pulse 89, and 99% oxygen saturation.  The patient was given something to eat as she had only a small breakfast and no lunch.  After further discussion with the provider, the mother stated that the symptoms started an hour and a half after she received the vaccine.  There was no swelling, redness or warmth at the injection site.  Patient?s repeat blood pressure thirty minutes later was 98/61 and pulse was 89, she was not flush-appearing and was starting to feel better.  The arm weakness had improved prior to being seen in clinic, and was completely resolved prior to her leaving the clinic.  She was observed for over an hour in clinic and was sent home with instructions to return should symptoms reappear.
Age: 1.75
Sex: F
Vaccine: DTAPHEPBIP
Symptoms: No adverse event, Wrong product administered
Clinical narrative: Pediarix given when patient was due for only Dtap. No adverse reaction. Provider notified.
Age: 31.0
Sex: F
Vaccine: PNC13
Symptoms: Chest X-ray normal, Fatigue, Lymphadenopathy, Pain in extremity, Ultrasound scan abnormal
Clinical narrative: Shortly after recieving the vaccination i expierenced the usual symptoms (fatigue, sore arm, etc). After a few days i noticed i had a lump inferior to the mid clavicle area. I assumed it to by a lymph node, and waited 4 weeks to see if it went away. When it did not go away I made an appt w/ my Dr. He ordered an ultrasound. It took almost three weeks to get an appt for ultrasound. They confirmed it was a 1.4cm lymph node, possible reactive. The report stated they could not rule out malignancy and suggested further test. My provider ordered a chest X-ray which came back negative for lung effusion or masses. However, once again the report said it could not rule out soft tissue tumors or malignancy. Im not awaiting a surgical consult for biopsy. Ive had this lymph node for nearly 3 months.
Age: 29.0
Sex: F
Vaccine: FLU4
Symptoms: Injection site bruising, Pain in extremity
Clinical narrative: Patient presented the day after receiving the flu shot with a "spidery-looking" bruising at the injection site. Patient said her arm hurt that night after receiving the flu shot and applied topical Biofreeze which said provided relief. Patient states the bruising was continuing to worsen and wanted to report the adverse event. Patient presented not in acute pain and was advised to apply a cold compress, if needed, and to continue to monitor if the bruise worsens. Advised patient to seek medical attention if bruise worsens or acute pain occurs and report the information to the pharmacy.
Age: 67.0
Sex: F
Vaccine: VARZOS
Symptoms: Urticaria
Clinical narrative: patient stated she got hives starting 1 day after administration.  she took benadryl to help with the hives
Age: 57.0
Sex: F
Vaccine: VARZOS
Symptoms: Rash, Rash erythematous
Clinical narrative: pt following day developed red raised rash over entire chest/neck area, and psread over next few days
Age: 58.0
Sex: F
Vaccine: VARZOS
Symptoms: Asthenia, Chest pain, Chills, Crying, Erythema
Clinical narrative: Started with a light headache , Left are sore and tired and swallon glands in jaw line. As the day progressed, symptoms worsen. By evening, started to run low fever with chills, aching all over and extremely tired. I could hardly stay awake.  I felt so bad with the chills and aching I went to bed early after taking 2 extra strenght Tylenol. I woke up crying around 2:00 am hurting so bad, I felt like someone beat me with a 2x4 board, so I took a Percocet 325 and went back to bed. When I woke up I had chills, severe pain all over, very weak and could hardly move my left arm which was red and swallon.  Then my skin was burning and itching in different places. I laid in my recliner and couldn't stay awake. Slept most of the day.  Fever stayed under 101 and finally stopped by Sunday morning, weakness stayed till Monday morning. Swallon glands in jaw line got better each day afterwards.
Age: 58.0
Sex: F
Vaccine: VARZOS
Symptoms: Fatigue, Headache, Injected limb mobility decreased, Lymphadenopathy, Pain
Clinical narrative: Started with a light headache , Left are sore and tired and swallon glands in jaw line. As the day progressed, symptoms worsen. By evening, started to run low fever with chills, aching all over and extremely tired. I could hardly stay awake.  I felt so bad with the chills and aching I went to bed early after taking 2 extra strenght Tylenol. I woke up crying around 2:00 am hurting so bad, I felt like someone beat me with a 2x4 board, so I took a Percocet 325 and went back to bed. When I woke up I had chills, severe pain all over, very weak and could hardly move my left arm which was red and swallon.  Then my skin was burning and itching in different places. I laid in my recliner and couldn't stay awake. Slept most of the day.  Fever stayed under 101 and finally stopped by Sunday morning, weakness stayed till Monday morning. Swallon glands in jaw line got better each day afterwards.
Age: 58.0
Sex: F
Vaccine: VARZOS
Symptoms: Pain in extremity, Peripheral swelling, Pruritus, Pyrexia, Skin burning sensation
Clinical narrative: Started with a light headache , Left are sore and tired and swallon glands in jaw line. As the day progressed, symptoms worsen. By evening, started to run low fever with chills, aching all over and extremely tired. I could hardly stay awake.  I felt so bad with the chills and aching I went to bed early after taking 2 extra strenght Tylenol. I woke up crying around 2:00 am hurting so bad, I felt like someone beat me with a 2x4 board, so I took a Percocet 325 and went back to bed. When I woke up I had chills, severe pain all over, very weak and could hardly move my left arm which was red and swallon.  Then my skin was burning and itching in different places. I laid in my recliner and couldn't stay awake. Slept most of the day.  Fever stayed under 101 and finally stopped by Sunday morning, weakness stayed till Monday morning. Swallon glands in jaw line got better each day afterwards.
Age: 58.0
Sex: F
Vaccine: VARZOS
Symptoms: Somnolence, Swelling face
Clinical narrative: Started with a light headache , Left are sore and tired and swallon glands in jaw line. As the day progressed, symptoms worsen. By evening, started to run low fever with chills, aching all over and extremely tired. I could hardly stay awake.  I felt so bad with the chills and aching I went to bed early after taking 2 extra strenght Tylenol. I woke up crying around 2:00 am hurting so bad, I felt like someone beat me with a 2x4 board, so I took a Percocet 325 and went back to bed. When I woke up I had chills, severe pain all over, very weak and could hardly move my left arm which was red and swallon.  Then my skin was burning and itching in different places. I laid in my recliner and couldn't stay awake. Slept most of the day.  Fever stayed under 101 and finally stopped by Sunday morning, weakness stayed till Monday morning. Swallon glands in jaw line got better each day afterwards.
Age: 66.0
Sex: F
Vaccine: HEP
Symptoms: Gait disturbance, Grip strength decreased
Clinical narrative: Patient called 2 weeks after the vaccine was administered stating that 48 hours after receiving the Hep B vaccine, she was dropping and having a hard time holding makeup brushes, as well as having a disturbance in her gait as she walked. No more vaccines administered after this due to reaction.
Age: 50.0
Sex: F
Vaccine: TDAP
Symptoms: Injected limb mobility decreased, Injection site erythema, Injection site pain, Injection site swelling, Loss of personal independence in daily activities
Clinical narrative: I started having  a reaction to the vaccine about 1pm in the afternoon. I found a big RED mark where the injection was put in along  with my arm being sore and swollen I was not able  to raise my hand about my head. Getting dressed is very difficult because putting my right arm in the sleeves is very painful. I cant  sleep on my side because of the pain and I have a pain in my neck that is also very bothersome.
Age: 50.0
Sex: F
Vaccine: TDAP
Symptoms: Neck pain, Pain, Vaccination complication
Clinical narrative: I started having  a reaction to the vaccine about 1pm in the afternoon. I found a big RED mark where the injection was put in along  with my arm being sore and swollen I was not able  to raise my hand about my head. Getting dressed is very difficult because putting my right arm in the sleeves is very painful. I cant  sleep on my side because of the pain and I have a pain in my neck that is also very bothersome.
Age: 20.0
Sex: F
Vaccine: HPV9
Symptoms: Injection site nodule, Injection site pain
Clinical narrative: Developed 2x2 palpable knot at injection site. Tender to touch
Sex: U
Vaccine: HPV9
Symptoms: No adverse event, Product storage error
Clinical narrative: improperly stored dose of GARDASIL 9 was administered; No adverse effect reported; This spontaneous report was received from a nurse, referring to patient of unknown age and gender. The patient's concurrent conditions, pertinent medical history, concomitant medications and previous drugs reactions or allergies were not provided.  On 28-AUG-2019, the patient was vaccinated with an improperly stored hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast) (GARDASIL 9) from a two doses series, as prophylaxis (concentration, number of administered dose, vaccination scheme frequency, route and anatomical location of vaccination were not reported; reported lot number 1614897, expiration date 20-SEP-2021, have been confirmed as valid) . No adverse effects were reported for the patient.  According to the reporter, the temperature excursion was 48.5 degrees Fahrenheit(°F) for a time frame of four hours and 15 minutes on an unspecified date (product storage error), without any previous temperature excursion; which was detected by a digital data logger, as the "no alarm went off".  This is one of three reports received from the same reporter.; Sender's Comments:  US-009507513-1908USA012909: US-009507513-1908USA012939: