chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 52.0
Sex: F
Vaccine: FLU3
Symptoms: Arthralgia, Back pain, Computerised tomogram normal, Dyspnoea, Electromyogram abnormal
Clinical narrative: Case number PHHY2015US059832, is an initial spontaneous report received from Vaccine Adverse Event Reporting System (VAERS reference number: 564617) website on 12 May 2015. This report refers to a 52-year-old female patient. The patient was allergic to penicillin and shellfish. Concomitant medications included losartan, SINGULAIR, fluoxetine, Niacin and Multivitamin for Women. The patient had no prior adverse events following immunizations. The patient was vaccinated with FLUVIRIN (batch number: 145301) intramuscularly into the left arm on 18 Sep 2014. On 17 Oct 2014, the patient experienced numbness and tingling in hands and feet. The symptoms grew worse and the patient went to emergency department on 19 Oct 2014. Computerized tomography (CT scan) was negative and the patient sent home. The patient was advised to follow up with primary care physician and neurologist. On 27 Oct 2014, the patient returned to primary care physician with complaints of numbness and tingling and increasing shortness of breath, with joint pain and trouble ambulating. The patient was admitted to local hospital where lumbar puncture and electromyogram confirmed Guillain-Barre Syndrome. The patient was treated with intravenous immunoglobulin (IVIG). The patient was hospitalized for five days and later the patient was discharged. The patient still had not regained full feeling in hands and feet. Further, the patient still had pain in hands, shoulders, left arm and lower back. Also the patient still had occasional difficulty with full movements. The final outcome of the events was condition unchanged. The seriousness of the events was reported as hospitalization. Causality was not reported.
Age: 52.0
Sex: F
Vaccine: FLU3
Symptoms: Gait disturbance, Guillain-Barre syndrome, Hypoaesthesia, Immunoglobulin therapy, Lumbar puncture abnormal
Clinical narrative: Case number PHHY2015US059832, is an initial spontaneous report received from Vaccine Adverse Event Reporting System (VAERS reference number: 564617) website on 12 May 2015. This report refers to a 52-year-old female patient. The patient was allergic to penicillin and shellfish. Concomitant medications included losartan, SINGULAIR, fluoxetine, Niacin and Multivitamin for Women. The patient had no prior adverse events following immunizations. The patient was vaccinated with FLUVIRIN (batch number: 145301) intramuscularly into the left arm on 18 Sep 2014. On 17 Oct 2014, the patient experienced numbness and tingling in hands and feet. The symptoms grew worse and the patient went to emergency department on 19 Oct 2014. Computerized tomography (CT scan) was negative and the patient sent home. The patient was advised to follow up with primary care physician and neurologist. On 27 Oct 2014, the patient returned to primary care physician with complaints of numbness and tingling and increasing shortness of breath, with joint pain and trouble ambulating. The patient was admitted to local hospital where lumbar puncture and electromyogram confirmed Guillain-Barre Syndrome. The patient was treated with intravenous immunoglobulin (IVIG). The patient was hospitalized for five days and later the patient was discharged. The patient still had not regained full feeling in hands and feet. Further, the patient still had pain in hands, shoulders, left arm and lower back. Also the patient still had occasional difficulty with full movements. The final outcome of the events was condition unchanged. The seriousness of the events was reported as hospitalization. Causality was not reported.
Age: 52.0
Sex: F
Vaccine: FLU3
Symptoms: Mobility decreased, Musculoskeletal pain, Pain in extremity, Paraesthesia
Clinical narrative: Case number PHHY2015US059832, is an initial spontaneous report received from Vaccine Adverse Event Reporting System (VAERS reference number: 564617) website on 12 May 2015. This report refers to a 52-year-old female patient. The patient was allergic to penicillin and shellfish. Concomitant medications included losartan, SINGULAIR, fluoxetine, Niacin and Multivitamin for Women. The patient had no prior adverse events following immunizations. The patient was vaccinated with FLUVIRIN (batch number: 145301) intramuscularly into the left arm on 18 Sep 2014. On 17 Oct 2014, the patient experienced numbness and tingling in hands and feet. The symptoms grew worse and the patient went to emergency department on 19 Oct 2014. Computerized tomography (CT scan) was negative and the patient sent home. The patient was advised to follow up with primary care physician and neurologist. On 27 Oct 2014, the patient returned to primary care physician with complaints of numbness and tingling and increasing shortness of breath, with joint pain and trouble ambulating. The patient was admitted to local hospital where lumbar puncture and electromyogram confirmed Guillain-Barre Syndrome. The patient was treated with intravenous immunoglobulin (IVIG). The patient was hospitalized for five days and later the patient was discharged. The patient still had not regained full feeling in hands and feet. Further, the patient still had pain in hands, shoulders, left arm and lower back. Also the patient still had occasional difficulty with full movements. The final outcome of the events was condition unchanged. The seriousness of the events was reported as hospitalization. Causality was not reported.
Age: 48.0
Sex: F
Vaccine: FLU3
Symptoms: Contusion, Haemorrhage subcutaneous, Hypersensitivity, Rash, Rash erythematous
Clinical narrative: Case number PHHY2015US059962, is an initial spontaneous report received from the Vaccine Adverse Event Reporting System (VAERS reference number: 564936) website on 12 May 2015. This report refers to a 48 years old female patient. Medical history and concomitant medications were not reported. She was vaccinated with FLUVIRIN (batch number: 145021) intramuscularly into left arm on 08 Nov 2014. On 10 Nov 2014, the patient developed red dots on her legs. The patient had a visit to the emergency room due to this event. Her doctor said it's bleeding under the skin/bruising, an allergic reaction to the vaccine. Outcome of the events was recovered. The events were assessed as non-serious. Causality of the events was not reported. Seriousness assessment of allergic reaction was upgraded based on information in the source document.
Age: 62.0
Sex: M
Vaccine: FLU3
Symptoms: Burning sensation, Decreased appetite, Erythema, Lymphadenopathy, Malaise
Clinical narrative: Case number PHHY2015US061645, is an initial spontaneous report received from the Vaccine Adverse Event Reporting System (VAERS reference number: 565672) website on 12 May 2015. This report refers to a 62 years old male patient. Medical history and concomitant medications were not reported. He was vaccinated with FLUVIRIN (batch number: 145003) intramuscularly into left arm on 10 Dec 2014. On 14 Dec 2014, the patient experienced swollen glands along left neck and bright red burning hives all over face from above eyebrows to jaw line. Further the patient experienced malaise, night sweats and loss of appetite for 6 to 7 weeks. The patient still had red patches on face. Final outcome of the events was reported as not recovered. Case was assessed as non-serious. Causality of the events was not reported. Seriousness assessment of hives was upgraded based on information in the source document.
Age: 62.0
Sex: M
Vaccine: FLU3
Symptoms: Night sweats, Urticaria
Clinical narrative: Case number PHHY2015US061645, is an initial spontaneous report received from the Vaccine Adverse Event Reporting System (VAERS reference number: 565672) website on 12 May 2015. This report refers to a 62 years old male patient. Medical history and concomitant medications were not reported. He was vaccinated with FLUVIRIN (batch number: 145003) intramuscularly into left arm on 10 Dec 2014. On 14 Dec 2014, the patient experienced swollen glands along left neck and bright red burning hives all over face from above eyebrows to jaw line. Further the patient experienced malaise, night sweats and loss of appetite for 6 to 7 weeks. The patient still had red patches on face. Final outcome of the events was reported as not recovered. Case was assessed as non-serious. Causality of the events was not reported. Seriousness assessment of hives was upgraded based on information in the source document.
Age: 70.0
Sex: M
Vaccine: FLU3
Symptoms: Asthenia, Dysarthria, Guillain-Barre syndrome
Clinical narrative: Case number PHHY2015US069269 is an initial spontaneous report received via Vaccine Adverse Event Reporting System (VAERS ID: 570804) on 09 Jun 2015. This report refers to a 70 year old male patient. His current conditions included polymyalgia rheumatica, gastrooesophageal reflux disease (GERD) and hyperlipidemia. His concomitant medications were not reported. He was vaccinated with FLUVIRIN (batch number: 145624) intramuscularly on 21 Nov 2014. On 22 Nov 2014, he experienced weakness and slurring of speech. He was hospitalized for 30 days and was later found to have Guillain Barre Syndrome. The events outcome was reported as condition unchanged. The events were reported as life threatening. The causality of the events was not reported.
Age: 61.0
Sex: F
Vaccine: FLU3
Symptoms: Swollen tongue
Clinical narrative: Case number PHHY2015US140132 is an initial spontaneous report from the Vaccine Adverse Event Reporting System (VAERS: 585525) website on 23 Oct 2015. This report refers to a 61-year-old female patient. She was vaccinated with FLUVIRIN (batch number: 1413301) intramuscularly in the left arm 25 Sep 2014. On the same date, few hours after vaccination she experienced tongue swelling. She was advised to take immediate treatment and was taken to the hospital and treated and kept overnight, hospitalized for one day. The outcome of the event reported as recovered. The causality assessment was not provided.
Age: 49.0
Sex: M
Vaccine: FLU3
Symptoms: Asthenia, Injected limb mobility decreased, Injection site pain, Pain, Pain in extremity
Clinical narrative: Nov. 12, received flu shot left shoulder (arm). Few hours later, bad pain in arm, deep within left arm. rotator cuff still in pain to this day Dec. 27. Can't lift arm only so high, throbbing, weakness, favoring right arm, fear to use left.
Age: 18.0
Sex: M
Vaccine: FLUN4, HPVX, MEN
Symptoms: Activities of daily living impaired, Blood pressure decreased, Hyperhidrosis, Pallor, Tinnitus
Clinical narrative: About 5 minutes after receiving the Meningococcal and HPV vaccines injected into his left arm, and the Flu vaccine administered nasally, he began having a reaction. He was standing beside me as I was sitting in a chair at the desk making his follow-up appointment, when he knelt down, put his head down, and said his ears were ringing. He then said his vision was "funny, kinda like tunnel vision". As a RN myself, I knew he could possibly be close to fainting, so I had him immediately sit in the chair beside me. I noticed he started to sweat profusely on his forehead, so the receptionist went to get him a cold, wet towel and I put it on the back of his neck. The office's Social Worker happened to be there at the front desk, so she went to get him some apple juice. I had my son put his head down and lean forward a bit, to get blood flowing to is brain. He was extremely pale so I also asked for the Medical Assistant to check his blood pressure, which was very low at 100/49 (it had been 122/78 at the beginning of his appointment around 9:15 AM). Someone brought him a package of goldfish crackers, and some water (because he had drank all of the apple juice). After about 10 minutes, he appeared much better, his color came back and the ringing in his ears along with the tunnel vision had gone away. He said "I feel much better". I took him home and checked his blood pressure, which was 138/82. I then had him eat/drink a little and rest for the remainder of the day. He was supposed to return to school after his appointment, but I thought it best to keep him home.
Age: 18.0
Sex: M
Vaccine: FLUN4, HPVX, MEN
Symptoms: Tunnel vision, Visual impairment
Clinical narrative: About 5 minutes after receiving the Meningococcal and HPV vaccines injected into his left arm, and the Flu vaccine administered nasally, he began having a reaction. He was standing beside me as I was sitting in a chair at the desk making his follow-up appointment, when he knelt down, put his head down, and said his ears were ringing. He then said his vision was "funny, kinda like tunnel vision". As a RN myself, I knew he could possibly be close to fainting, so I had him immediately sit in the chair beside me. I noticed he started to sweat profusely on his forehead, so the receptionist went to get him a cold, wet towel and I put it on the back of his neck. The office's Social Worker happened to be there at the front desk, so she went to get him some apple juice. I had my son put his head down and lean forward a bit, to get blood flowing to is brain. He was extremely pale so I also asked for the Medical Assistant to check his blood pressure, which was very low at 100/49 (it had been 122/78 at the beginning of his appointment around 9:15 AM). Someone brought him a package of goldfish crackers, and some water (because he had drank all of the apple juice). After about 10 minutes, he appeared much better, his color came back and the ringing in his ears along with the tunnel vision had gone away. He said "I feel much better". I took him home and checked his blood pressure, which was 138/82. I then had him eat/drink a little and rest for the remainder of the day. He was supposed to return to school after his appointment, but I thought it best to keep him home.
Age: 11.0
Sex: F
Vaccine: HPV4, MNQ, TDAP
Symptoms: Abdominal pain upper, Cyanosis, Oral mucosal discolouration, Staring, Syncope
Clinical narrative: Syncope, extreme paleness to oral mucosa to include lips turning blue, stomach pains, gazing.
Age: 68.0
Sex: M
Vaccine: FLU3
Symptoms: Campylobacter test positive, Diarrhoea, Injection site pain, Pain in extremity
Clinical narrative: Shooting left arm pain presenting approximately 3 days post injection lasting 7-10 days. Pt then progressed to diarrhea for 10 days (treated with IV fluids and oral antibiotics) and fecal sample was taken. Arm pain increased to a radiating pain from left deltoid to elbow. Diarrhea resolved after antibiotics and arm pain is still present. Fecal sample yielded campylobacter diagnosis.
Age: 11.0
Sex: M
Vaccine: FLU3, MENB, MNQ, TDAP
Symptoms: Injection site cellulitis
Clinical narrative: Cellulitis on injection sites. Treatment of diphenhydramine 12.5 mg/5 mL was started on 1/7/16 for 10 days.
Age: 36.0
Sex: F
Vaccine: TDAP
Symptoms: Arthralgia, Joint stiffness
Clinical narrative: Stiffening and soreness of thumb joint. Ongoing.
Age: 1.19
Sex: M
Vaccine: FLU3, MMRV, PNC13
Symptoms: Abasia, Dysstasia, Hypothermia, Laboratory test, Lethargy
Clinical narrative: Began with on going high fevers, then was unable to walk to stand, became hypothmeric, and lethargic. Sent to hosp and admitted. Needed spinal tap, and many tests exposing him to much radiation. He is still having hypothermic temperatures and requiring on going tests.
Age: 1.19
Sex: M
Vaccine: FLU3, MMRV, PNC13
Symptoms: Lumbar puncture, Nuclear magnetic resonance imaging, Pyrexia, X-ray
Clinical narrative: Began with on going high fevers, then was unable to walk to stand, became hypothmeric, and lethargic. Sent to hosp and admitted. Needed spinal tap, and many tests exposing him to much radiation. He is still having hypothermic temperatures and requiring on going tests.
Age: 67.0
Sex: F
Vaccine: PPV
Symptoms: Nerve block, Nuclear magnetic resonance imaging, Scan
Clinical narrative: Antibiotics, Z pack, Steriod Injection, Nerve Block, Another Nerve Block scheduled for 01/12/2016.
Sex: U
Vaccine: MMRV
Symptoms: Incorrect product storage
Clinical narrative: This spontaneous report was received from a physician refers to a patient of unknown age and gender. On 03-SEP-2015, the patient was vaccinated with improperly stored PROQUAD (Merck) lot # K025766, expiry date 08-JUN-2015. This is one of the several reports received from the same reporter. Additional information has been requested.
Sex: U
Vaccine: VARZOS
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report has been received from a registered nurse referring to an unspecified number patient of unknown age and gender. Medical history and concurrent conditions were not provided. The register nurse stated that an unspecified number of patients were vaccinated with ZOSTAVAX (lot # L000448 and expiration date 08-MAR-2016) (dose, and frequency were not provided), that were improperly stored. Concomitant therapies were not provided. The reporter reported that these doses were administered between December 2015 and 04-JAN-2016. No adverse effects were reported. Additional information has been requested.
Sex: U
Vaccine: RV5
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: Thus spontaneous report as received from a medical assistant refers to an unspecified number of patients of unknown age and unknown gender. No medical history or concurrent conditions were reported. On an unknown date, the patients were vaccinated with improperly stored ROTATEQ, administered orally, with lot # L013188 and expiry date 02-NOV-2016 (dosage and dosage number were not reported). No adverse effects were reported. Additional information has been requested.
Sex: U
Vaccine: HEPA
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report has been received from a registered nurse. The reporter stated that improperly stored doses of VAQTA (strength, dose number, route not reported, lot number L028666 expiration date 04-NOV-2016) were administered to an unspecified number of unspecified patients on unspecified dates. No adverse effects were reported. No further information was provided. This is one of several reports from the same source. Additional information has been requested.
Age: 4.0
Sex: F
Vaccine: DTAP, FLU4, IPV, MMRV
Symptoms: Discomfort, Hypersensitivity, Injection site erythema, Injection site pain, Injection site pruritus
Clinical narrative: 4/15/15 Mother presents to the window with child for vaccines. On record, child has only had up to 6 month shots. Mother reports that was in another location. Mother reports that received vaccines here. Clinic was at this time they are at lunch, as they are an hour ahead. Later appt. scheduled to allow for time to get records. PC and spoke with staff at that clinic and will fax records and child appears UTD. Does need flu vaccine if not done this year. Records put into electronic records. 1/6/2016: PC from mother to report that "child's right arm became red and puffy last night". This morning the swelling/redness reaches from her armpit to elbow and covers the back and side of her forearm, but does not completely circle around the front. Temperature of 100.4 at 5:30pm last evening; gave TYLENOL at 6:00pm last evening. Child was "up and down last night and whiny during the night". Not using arm today and child says "it hurts" and attempts to rub up against things due to itching. Gave Ibuprofen at 8:00am today for discomfort. Temperature 100.2 at 10:49am today. Mother instructed to call Dr. today for followup. Encouraged to apply cool packs to arm for comfort and continued with TYLENOL/Ibuprofen per Dr.'s recommendations. Parent reports no previous problems associated with vaccine administration in the past. Parent v/u. PC to LPN with Dr. and apprised of situation and copy of consent faxed to Dr.'s office today so that they can see what vaccines were given and what sites. VAERS to be completed. 1/7/2016: PC to mother to check status of child. Child seen by NP with Dr. and reaction was noted as "allergic reaction" per mother. Child given BENADRYL and has had 3 doses since being evaluated. Parent continues to alternate TYLENOL and Ibuprofen. Low grade temp. persists today. Parent continues with cool compresses to affected right arm. Parent reports that redness and swelling had increased more last evening, but has "greatly improved this morning". Child even using her arm more today.
Age: 4.0
Sex: F
Vaccine: DTAP, FLU4, IPV, MMRV
Symptoms: Injection site swelling, Pyrexia
Clinical narrative: 4/15/15 Mother presents to the window with child for vaccines. On record, child has only had up to 6 month shots. Mother reports that was in another location. Mother reports that received vaccines here. Clinic was at this time they are at lunch, as they are an hour ahead. Later appt. scheduled to allow for time to get records. PC and spoke with staff at that clinic and will fax records and child appears UTD. Does need flu vaccine if not done this year. Records put into electronic records. 1/6/2016: PC from mother to report that "child's right arm became red and puffy last night". This morning the swelling/redness reaches from her armpit to elbow and covers the back and side of her forearm, but does not completely circle around the front. Temperature of 100.4 at 5:30pm last evening; gave TYLENOL at 6:00pm last evening. Child was "up and down last night and whiny during the night". Not using arm today and child says "it hurts" and attempts to rub up against things due to itching. Gave Ibuprofen at 8:00am today for discomfort. Temperature 100.2 at 10:49am today. Mother instructed to call Dr. today for followup. Encouraged to apply cool packs to arm for comfort and continued with TYLENOL/Ibuprofen per Dr.'s recommendations. Parent reports no previous problems associated with vaccine administration in the past. Parent v/u. PC to LPN with Dr. and apprised of situation and copy of consent faxed to Dr.'s office today so that they can see what vaccines were given and what sites. VAERS to be completed. 1/7/2016: PC to mother to check status of child. Child seen by NP with Dr. and reaction was noted as "allergic reaction" per mother. Child given BENADRYL and has had 3 doses since being evaluated. Parent continues to alternate TYLENOL and Ibuprofen. Low grade temp. persists today. Parent continues with cool compresses to affected right arm. Parent reports that redness and swelling had increased more last evening, but has "greatly improved this morning". Child even using her arm more today.
Sex: U
Vaccine: MMRV
Symptoms: Incorrect product storage
Clinical narrative: This spontaneous report was received from a physician refers to a patient of unknown age and gender. On 14-SEP-2015, the patient was vaccinated with improperly stored PROQUAD (Merck) lot # K025766, expiry date 08-JUN-2015. This is one of the several reports received from the same reporter. Additional information has been requested.
Sex: U
Vaccine: HPV9
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report has been received from a registered nurse. The reporter stated that improperly stored doses of GARDASIL 9 (strength, dose number, route not reported, lot number L025737 expiration date 280JUL-2017) were administered to an unspecified number of unspecified patients on unspecified dates. No adverse effects were reported. No further information was provided. This is one of several reports from the same source. Additional information has been requested.
Sex: M
Vaccine: RV5
Symptoms: Frequent bowel movements
Clinical narrative: This spontaneous report as received from a physician who was also the patient's mother via company representative and refers to a male patient of unknown age. The patient's medical history and current conditions were not provided. On an unknown date approximately in 2015 (reported as "a few weeks ago"), the patient was vaccinated with a dose of ROTATEQ (lot #, expiration date and dose were not reported), orally. Secondary suspects and concomitant therapies were not reported. On an unknown date approximately in 2015, the patient "went from 1-2 poopy diapers a day to 6-8 poopy diapers per day" after therapy with ROTATEQ. It was unknown if ROTATEQ series was complicated. The outcome of adverse event was unknown. The patient did not seek medical attention. The relatedness between adverse event and ROTATEQ was not reported, Additional information is not expected due to a lack of contact reporter.
Age: 19.0
Sex: M
Vaccine: MENB
Symptoms: Chest X-ray, Electrocardiogram, Myocardial necrosis marker, Palpitations, Tachycardia
Clinical narrative: Patient experienced palpitations and tachycardia approximately 36 hrs after receiving TRUMENBA (meningitis B vaccine).
Sex: F
Vaccine: HEP
Symptoms: Aphasia, Dysphagia, Pain
Clinical narrative: This spontaneous report was received from a female patient who at the time of the report was 68 years old and was reporting regarding herself. No medical history or concurrent conditions were reported. On an unknown date, the patient was vaccinated with the first dose of RECOMBIVAX HB (dosage, frequency, route of administration, lot# and expiry date were not reported). Following vaccination, the patient experienced "aching all over her entire body for 1 week". Then, on an unknown date, after receiving the first dose of the vaccine, the patient was vaccinated with a second dose of RECOMBIVAX HB. Subsequently, the patient stated that she developed difficulty swallowing and was "unable to speak". The patient also stated that she sought medical attention and was administered with EPIPEN as treatment on an unspecified date following the occurrence of the events of dysphagia and aphasia. The outcome of aphasia and dysphagia were unknown but the patient recovered from the pain. No causal relationship was stated between the events and vaccination with RECOMBIVAX HB. Upon internal review, the event of aphasia was considered to be medically significant. Additional information has been requested.
Age: 60.0
Sex: M
Vaccine: FLU3
Symptoms: Dizziness, Vertigo, Walking aid user
Clinical narrative: Severe vertigo began 24 hours after flu shot. Pt woke up w/vertigo/dizziness. No nausea/vomiting. Must use a cane to walk now. Got flu vaccine 1 day after testosterone administration.
Age: 6.0
Sex: M
Vaccine: FLU4
Symptoms: Urticaria
Clinical narrative: Hives 1 day post influenza vacc. Referral to Allergist. BENADRYL 1-1 1/2 tabs q 6 hours PRN.
Sex: U
Vaccine: HPV9
Symptoms: Interchange of vaccine products, No adverse event
Clinical narrative: This spontaneous report received from a physician assistant refers to an unspecified patient with unknown demographics. No medical history was reported. On an unknown date in August 2015, the patient was vaccinated with firs dose of GARDASIL (route, dose and frequency: unknown). On 28-DEC-2015, the patient was in the reporting physician assistant office to receive second dose in the HPV series with GARDASIL 9. No adverse effect was reported. No product quality complaint (PQC) was involved. Additional information has been requested.
Age: 20.0
Sex: F
Vaccine: MNQ, TYP
Symptoms: Colitis ulcerative
Clinical narrative: Had symptoms of ulcerative colitis by 9/05. Diagnosed with ulcerative colitis in 1/06.
Age: 15.0
Sex: F
Vaccine: HPV4, FLUX
Symptoms: Abdominal distension, Abdominal pain, Decreased appetite, Immediate post-injection reaction, Postural orthostatic tachycardia syndrome
Clinical narrative: Chronic abd pain, bloating, loss of appetite spring 2013. POTS - summer 2015. Fainting 11/16/12 - immed after vaccine.
Age: 15.0
Sex: F
Vaccine: HPV4, FLUX
Symptoms: Syncope
Clinical narrative: Chronic abd pain, bloating, loss of appetite spring 2013. POTS - summer 2015. Fainting 11/16/12 - immed after vaccine.
Age: 15.0
Sex: F
Vaccine: HPV4, FLUX
Symptoms: Angioedema, Urticaria
Clinical narrative: Chronic abd pain, bloating, loss of appetite spring 2013. POTS - summer 2015. Fainting 11/16/12 - immed after vaccine.
Age: 1.25
Sex: M
Vaccine: HIBV, MMR, VARCEL
Symptoms: Blood immunoglobulin E normal, Injection site urticaria
Clinical narrative: Hives at site of MMR vaccine and on back 5 minutes after vaccine given.
Age: 78.0
Sex: F
Vaccine: FLU3, PNC13
Symptoms: Acute respiratory distress syndrome, CSF culture negative, CSF glucose increased, CSF protein increased, Endotracheal intubation
Clinical narrative: Admitted to Hospital 12/20/15 acute resp. distress, HTN crisis, facial/cervical numbness. Reported GBS. Intubated, trach and PEG placed, plasma exchanges.
Age: 78.0
Sex: F
Vaccine: FLU3, PNC13
Symptoms: Gastrostomy, Guillain-Barre syndrome, Hypertensive crisis, Hypoaesthesia, Plasmapheresis
Clinical narrative: Admitted to Hospital 12/20/15 acute resp. distress, HTN crisis, facial/cervical numbness. Reported GBS. Intubated, trach and PEG placed, plasma exchanges.
Age: 78.0
Sex: F
Vaccine: FLU3, PNC13
Symptoms: Tracheostomy
Clinical narrative: Admitted to Hospital 12/20/15 acute resp. distress, HTN crisis, facial/cervical numbness. Reported GBS. Intubated, trach and PEG placed, plasma exchanges.
Age: 31.0
Sex: F
Vaccine: FLU4
Symptoms: Guillain-Barre syndrome
Clinical narrative: Patient is the mother of a patient of mine. She received her flu vaccine in our office. She was admitted to the hospital for Guillain-Barre. I do not know the details of her symptoms.
Age: 71.0
Sex: F
Vaccine: PPV
Symptoms: Chest X-ray, Full blood count, Injection site erythema, Injection site pain, Injection site pruritus
Clinical narrative: Patient got Pneumonia vaccine adult on 12/28/15 at 6 PM (L) deltoid muscle. At 1 AM on 12/29/15, pt c/o pain on (L) upper arm w/redness and swelling and pruritus.
Age: 71.0
Sex: F
Vaccine: PPV
Symptoms: Injection site swelling
Clinical narrative: Patient got Pneumonia vaccine adult on 12/28/15 at 6 PM (L) deltoid muscle. At 1 AM on 12/29/15, pt c/o pain on (L) upper arm w/redness and swelling and pruritus.
Age: 0.2
Sex: U
Vaccine: MMR
Symptoms: Drug administered to patient of inappropriate age, No adverse event
Clinical narrative: This spontaneous report as received from a certified medical assistant refers to a 2 month old patient of unknown gender. The patient's medical history, concurrent conditions and concomitant medications were not reported. On 05-JAN-2016, the patient was vaccinated with a dose of M-M-R II (lot # L02464, expiration date 01-JUL-2017; dose and route of administration were not reported). No adverse effects were reported. Additional information has been requested.
Sex: U
Vaccine: VARCEL
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report as received from a Licensed Practical Nurse refers to patients of unknown age and gender. There were no concomitant medications, concurrent conditions and medical history reported. On an unknown dates, 12 unspecified patients received doses of improperly stored (Oka/Merck) VARIVAX lot # L029469 expiration date: 06-AUG-2017 (dose, route and site of administration were not reported). There were no adverse effects reported. Additional information has been requested.
Sex: M
Vaccine: VARZOS
Symptoms: Drug administered to patient of inappropriate age, No adverse event
Clinical narrative: This spontaneous report was received from a patient's mother and refers to a male pediatric patient of an unknown age. The patient's concurrent conditions, medical history and concomitant therapy were not reported. On an unknown date, the pediatric patient was accidentally vaccinated with an unspecified dose of ZOSTAVAX (dose, lot#, expiration date and route of administration were not reported). The patient had no adverse effects at the time of this report. Additional information is not expected because no contact details were provided.
Sex: U
Vaccine: MMRV
Symptoms: Incorrect product storage
Clinical narrative: This spontaneous report was received from a physician refers to a patient of unknown age and gender. On 31-AUG-2015, the patient was vaccinated with improperly stored PROQUAD (Merck) lot # K025766, expiry date 08-JUN-2015. This is one of the several reports received from the same reporter. Additional information has been requested.
Age: 62.0
Sex: F
Vaccine: FLUC3
Symptoms: Dysphonia, Headache, Nausea, Pharyngeal oedema, Photophobia
Clinical narrative: 1pm - headache; 5:30 - nausea, hoarseness, throat swelling; 6:00 - sensitivity to light; 6:45 - vomiting.
Age: 62.0
Sex: F
Vaccine: FLUC3
Symptoms: Vomiting
Clinical narrative: 1pm - headache; 5:30 - nausea, hoarseness, throat swelling; 6:00 - sensitivity to light; 6:45 - vomiting.
Age: 1.06
Sex: M
Vaccine: DTAP, HEPA, HIBV, MMRV
Symptoms: Injection site erythema, Injection site nodule, Injection site swelling, Irritability
Clinical narrative: 12/30/14 (R) leg knot, red, swollen: MOTRIN/TYLENOL given; Cool compress applied; Consulted dr.; Increased fluids; Fu with private MR or ER 12/31/15 mom states 3 knots now; cranky; afebrile per dr control with MOTRIN and compresses; F/U with ER or MD prn.
Age: 70.0
Sex: F
Vaccine: FLU3, PPV
Symptoms: Erythema, Hypersensitivity, Pain in extremity
Clinical narrative: Mild allergic reaction. Soreness in left arm, redness in left arm. Pt took ibuprofen for pain.
Age: 71.0
Sex: F
Vaccine: FLU3
Symptoms: Asthenia, Fatigue, Herpes zoster
Clinical narrative: Approximately 1 mo. after receiving, developed "shingles" involving (L) facial and trigeminal nerve. Tx with - steroids, pain med. and Magic mouthwash. Fatigue and weakness persists.
Age: 58.0
Sex: M
Vaccine: FLUX, PPV
Symptoms: Chest X-ray, Chills, Diarrhoea, Dizziness, Electrocardiogram
Clinical narrative: Dizziness, diarrhea repeatedly violently, vomiting repeatedly violently, headache, chills, fever of 101.2. Treated at clinic with e.k.g., chest exray, Zofran, Tylenol. Diarrhea and vomiting continue on 3rd day, recovering.
Age: 58.0
Sex: M
Vaccine: FLUX, PPV
Symptoms: Headache, Pyrexia, Vomiting
Clinical narrative: Dizziness, diarrhea repeatedly violently, vomiting repeatedly violently, headache, chills, fever of 101.2. Treated at clinic with e.k.g., chest exray, Zofran, Tylenol. Diarrhea and vomiting continue on 3rd day, recovering.
Age: 0.37
Sex: M
Vaccine: DTAPIPVHIB, PNC13, RV5
Symptoms: Dyskinesia
Clinical narrative: Had repetitive jerking of right arm with some jerking of head to the right, lasting a few seconds; occurred twice; patient remained alert during episode; parent called nurse line, advised to have child seen; child not seen until next well exam (at 6 months of age).
Age: 36.0
Sex: M
Vaccine: FLU4
Symptoms: Dizziness, Vomiting
Clinical narrative: Husband of client received IIV4 Flulaval at 2:25 pm on 1/6/16 during a clinic visit with wife and 4 week old infant. This client is a 36 year old male with no history of illness and no history of chronic illness. Client was asked all required and necessary questions regarding past experience with vaccinations, allergies to eggs and/or vaccine components. Client stated no negative events occurred from vaccinations, the last vaccination being a TD. This was his first flu shot he was receiving to protect his 4 week old daughter. Flulaval  (Lot: AT3CC, NCD 19515-898-11), 0.5ml, was administered IM to right deltoid at 2:25pm. Fifteen minutes following vaccination with Flulaval client reports going into bathroom, feeling lightheaded, lowering himself to the floor and then vomited. He returned to office and then reported to another nurse that he had nearly passed out when he had a vaccination in the past. Vital signs were taken, 108/76, Pulse regular 80. Client appeared pale and was sat at table, provided a drink, and asked to remain in place for monitoring. At 3:30pm this client desired to leave with wife/baby reporting he felt better. His pulse was 80 regular. At time of event the Nursing Supervisor was informed and present for entire follow up monitoring. Client was advised at time of department from office to seek medical attention for further symptoms. A follow up telephone call was made to client at 4 pm, he was attempting to eat, but reports vomiting what he had eaten. This RN instructed patient to have wife drive him home, and to lay down.
Age: 0.33
Sex: M
Vaccine: DTAPIPVHIB, PNC13, RV5
Symptoms: Enema administration, Intussusception, Ultrasound abdomen abnormal
Clinical narrative: Intussusception (confirmed radiologically) - reduced by air enema.
Sex: U
Vaccine: MMRV
Symptoms: Incorrect product storage
Clinical narrative: This spontaneous report was received from a physician refers to a patient of unknown age and gender. On 25-AUG-2015, the patient was vaccinated with improperly stored PROQUAD (Merck) lot # K025766, expiry date 08-JUN-2015. This is one of the several reports received from the same reporter. Additional information has been requested.
Sex: F
Vaccine: VARZOS
Symptoms: Herpes zoster
Clinical narrative: This spontaneous report as received from a physician via company representative refers to a female patient of unknown age. The patient's medical history and current conditions were not provided. On an unknown date, the patient was vaccinated with a dose of ZOSTAVAX (lot number and expiration date were not reported) 0.65 ml, single injection, subcutaneous. Secondary suspects and concomitant therapies were not reported. The patient was diagnosed with shingles on three separate unspecified dates after receiving a vaccine injection of ZOSTAVAX. The outcome of shingles was unknown. The patient sought medical attention via contacting with physician. The relatedness shingles event and ZOSTAVAX was not reported. Additional information has been requested.
Sex: U
Vaccine: MMRV
Symptoms: Incorrect product storage
Clinical narrative: This spontaneous report was received from a physician refers to a patient of unknown age and gender. On 27-AUG-2015, the patient was vaccinated with improperly stored PROQUAD (Merck) lot # K025766, expiry date 08-JUN-2015. This is one of the several reports received from the same reporter. Additional information has been requested.
Age: 15.0
Sex: F
Vaccine: MENB
Symptoms: Injection site erythema, Injection site pain, Injection site rash, Injection site reaction, Rash macular
Clinical narrative: 12 hrs after vaccine, blotchy red, non-raised rash formed dependent to injection site below deltoid muscle. Lasted 2 days. Painful but not itchy.
Age: 4.0
Sex: M
Vaccine: DTAPIPV, FLU3, MMRV
Symptoms: Cough, Pruritus, Rash
Clinical narrative: Approximately 10minutes after child received vaccines, child presented with cough, rash, itching.  Epi Jr 0.15mg IM administered, Neb treatment (Proventil/atrovent) administered, transferred to ER.
Age: 64.0
Sex: F
Vaccine: FLU3
Symptoms: Eye pain, Facial pain, Gastrointestinal pain, Trigeminal neuralgia
Clinical narrative: Case number PHEH2015US027552 is an initial spontaneous report received from a consumer (patient) on 31 Dec 2015. This report refers to a 64 year old female patient. Her medical history and concomitant medications were not reported. The patient was vaccinated with FLUVIRIN (batch number: not reported) intramuscularly in Dec 2015. On 29 Dec 2015, 36 hours after vaccination, the patient experienced trigeminal neuralgia. The patient stated that she had severe gastrointestinal (GI) pain followed by facial pain radiating from the corner of the left eye. The events outcome was not reported, however stop date of the event was reported as 29 Dec 2015. The seriousness of the event was not reported, but the event trigeminal neuralgia was upgraded as medically significant based on the information available in the source documents. The causality of the events was not reported. The reporter denied consent to contact for further follow ups and hence the case was considered as lost to follow up.
Age: 51.0
Sex: M
Vaccine: FLUX
Symptoms: Herpes zoster, Paraesthesia, Pruritus
Clinical narrative: Itching, tingling of effected areas--right torso. Began spraying with Bactine to desensitize best possible.
Age: 22.0
Sex: M
Vaccine: MNQ, TDAP
Symptoms: Pyrexia
Clinical narrative: Fever starting about 7 hours after vaccination.  Continued for 2 days and resolved without intervention.
Age: 22.0
Sex: F
Vaccine: FLU3
Symptoms: Cough, Eye swelling, Headache, Injection site rash, Ocular hyperaemia
Clinical narrative: Case number PHEH2015US011658, is an initial spontaneous report from a nurse received on 15 Jun 2015. This report refers to a 22 years old female patient. Medical history and concomitant medications were not reported. She was vaccinated with FLUVIRIN (batch number: 1412301A) intramuscularly on 11 Jun 2015. On 12 Jun 2015, the patient experienced post nasal drip drainage, coughing, sneezing, sore throat, swollen eyes and rash on arm of injection site followed by headache. On 13 Jun 2015, the patient experienced red swollen eyes and rash on arm of injection site. All these symptoms recovered as of 15 Jun 2015. Seriousness and causality of the events was not reported. Seriousness assessment of red swollen eyes was upgraded based on information in the source document.
Age: 22.0
Sex: F
Vaccine: FLU3
Symptoms: Oropharyngeal pain, Sneezing, Upper-airway cough syndrome
Clinical narrative: Case number PHEH2015US011658, is an initial spontaneous report from a nurse received on 15 Jun 2015. This report refers to a 22 years old female patient. Medical history and concomitant medications were not reported. She was vaccinated with FLUVIRIN (batch number: 1412301A) intramuscularly on 11 Jun 2015. On 12 Jun 2015, the patient experienced post nasal drip drainage, coughing, sneezing, sore throat, swollen eyes and rash on arm of injection site followed by headache. On 13 Jun 2015, the patient experienced red swollen eyes and rash on arm of injection site. All these symptoms recovered as of 15 Jun 2015. Seriousness and causality of the events was not reported. Seriousness assessment of red swollen eyes was upgraded based on information in the source document.
Age: 38.0
Sex: F
Vaccine: FLU3
Symptoms: Feeling abnormal, Speech disorder, Swollen tongue
Clinical narrative: Case number PHEH2015US019080, is an initial spontaneous report from a nurse received on 25 Sep 2015. This report refers to a 38 years old female patient. Medical history and concomitant medications were not reported. She was vaccinated with FLUVIRIN PFS (batch number: 15755P) intramuscularly on 22 Sep 2015. On the same day evening she developed swollen tongue. She was seen in the morning of 25 Sep 2015, tongue was still swollen, visual teeth ridges on the tongue, no difficulty breathing, no erythema or rash, no pain or fatigue. Her speech was little affected and the swelling was going down. Further she feels like her mouth was full of her tongue. It was reported that she never had a reaction previously. Final outcome of the events was unknown. Seriousness and causality of the events were not reported. Seriousness assessment of swollen tongue was upgraded based on information in the source document.
Age: 6.0
Sex: M
Vaccine: FLU3
Symptoms: Syncope
Clinical narrative: Case number PHEH2015US021898 is an initial spontaneous report from a health care professional received on 26 Oct 2015. This report refers to a 06-year-old male patient. He was vaccinated with FLUVIRIN (batch number: 1514701) at a dose of 0.5 ml intramuscularly on 21 Oct 2015. Shortly after vaccination, the patient fainted. The outcome of the event was unknown. The seriousness and causality of the event were not reported. Seriousness assessment of the event faint upgraded based on the available information in the source document.
Sex: F
Vaccine: FLU3
Symptoms: Hypersensitivity
Clinical narrative: Case number PHEH2015US019982, is an initial spontaneous report from a nurse received on 06 Oct 2015. This report refers to a female patient of an unknown age. Past medical history and concomitant medication were not reported. Concurrent condition included allergy to latex. She was vaccinated with FLUVIRIN (batch number and expiry date: not reported) intramuscularly on 01 Oct 2015 and experienced severe allergic reaction to vaccine because she was allergic to latex. The patient was presented to emergency department (ED) where she was treated (unspecified) and released on an unknown date. Outcome, seriousness and causality of the event were not reported. Seriousness assessment of the event allergic reactions to vaccine was upgraded based on information available in the source document.
Age: 11.0
Sex: F
Vaccine: HEPA, MNQ
Symptoms: Injection site erythema, Injection site induration, Injection site pain
Clinical narrative: Erythema and pain around injection site (left buttock) that was first noticed in the afternoon of 1/4/16.  Redness and pain spread over the next 36 hours.  Decreased in size by time of examination on 1/6/16.  Associated symptoms was also small area of induration around injection site and itching.
Age: 31.0
Sex: F
Vaccine: FLUN4
Symptoms: Anaphylactic reaction, Dyspnoea, Throat irritation
Clinical narrative: Anaphylaxis, labored breathing, itchy throat.
Age: 1.42
Sex: F
Vaccine: DTAP, HIBV, PNC13
Symptoms: Anion gap increased, Bacterial infection, Blood glucose increased, Blood urea nitrogen/creatinine ratio increased, C-reactive protein increased
Clinical narrative: Admitted to ist Hospital for bilateral upper thigh cellulitis. Bacterial infection is most likely the cause of her cellulitis given the history of thigh injections yesterday, physical exam findings, and spiking fevers. Local inflammatory response or allergic reaction to vaccine component is included in the differentials as well.
Age: 1.42
Sex: F
Vaccine: DTAP, HIBV, PNC13
Symptoms: Carbon dioxide decreased, Differential white blood cell count abnormal, Full blood count abnormal, Hypersensitivity, Inflammation
Clinical narrative: Admitted to ist Hospital for bilateral upper thigh cellulitis. Bacterial infection is most likely the cause of her cellulitis given the history of thigh injections yesterday, physical exam findings, and spiking fevers. Local inflammatory response or allergic reaction to vaccine component is included in the differentials as well.
Age: 1.42
Sex: F
Vaccine: DTAP, HIBV, PNC13
Symptoms: Injection site cellulitis, Lymphocyte count normal, Mean platelet volume normal, Metabolic function test abnormal, Pyrexia
Clinical narrative: Admitted to ist Hospital for bilateral upper thigh cellulitis. Bacterial infection is most likely the cause of her cellulitis given the history of thigh injections yesterday, physical exam findings, and spiking fevers. Local inflammatory response or allergic reaction to vaccine component is included in the differentials as well.
Age: 1.42
Sex: F
Vaccine: DTAP, HIBV, PNC13
Symptoms: Red blood cell sedimentation rate increased
Clinical narrative: Admitted to ist Hospital for bilateral upper thigh cellulitis. Bacterial infection is most likely the cause of her cellulitis given the history of thigh injections yesterday, physical exam findings, and spiking fevers. Local inflammatory response or allergic reaction to vaccine component is included in the differentials as well.
Age: 0.26
Sex: M
Vaccine: DTAPIPVHIB, PNC13, RV5
Symptoms: Diarrhoea, Pyrexia, Vomiting
Clinical narrative: Episode of limpness requiring a call to 911. The patient was seen here on Monday (01/04/2016) for a well check and received his DPT, Prevnar, Hib and Rotateq in the morning. According to mom he went home and had no fever but was more tired than usual. On 01/06/16 during a.m. feeding, he acutely vomited a large amount and had watery diarrhea. At that time he became extremely fussy and inconsolable for about 5 min then he went limp and was unarousable but was breathing shallowly. The parents called 911 and in the meantime tried to arouse the patient he did not arouse until mom says she put some ice on his legs. There estimation of the amount of time between the vomiting and the end of the episode was about 10 min. The EMTs came and did an EKG which they state was normal but they did not take him to the hospital. He had no fever last night and had no new movements during the limp episode. He has been well since the episode without any fever, vomiting, diarrhea. He has been feeding his normal.
Age: 1.17
Sex: M
Vaccine: HEPA, MMRV, PNC13, VARCEL, MMRV, VARCEL
Symptoms: Extra dose administered, No adverse event
Clinical narrative: Pt was incorrectly administered MMRV & Varicella simultaneously. No adverse reaction appreciated.
Age: 58.0
Sex: F
Vaccine: FLUC3
Symptoms: Blood test, Eye pain, Headache, Migraine, Visual impairment
Clinical narrative: Sharp pain in my temple, eye and a black spot in my vision. Terrible migraines along with the sharp pains in the temple.   It just continued to progress and the pain and the black spot continued to grow.