chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 3.0
Sex: M
Vaccine: PPV
Symptoms: C-reactive protein increased, Erythema, Pain, Pyrexia, Red blood cell sedimentation rate increased
Clinical narrative: Patient developed high fever up to 104 degrees, with severe localized pain, vomiting, redness to the area, and a systemic inflammatory-response-like syndrome. He was hospitalized.
Age: 3.0
Sex: M
Vaccine: PPV
Symptoms: Systemic inflammatory response syndrome, Vomiting, White blood cell count increased
Clinical narrative: Patient developed high fever up to 104 degrees, with severe localized pain, vomiting, redness to the area, and a systemic inflammatory-response-like syndrome. He was hospitalized.
Age: 4.0
Sex: M
Vaccine: DTAPIPV, FLU4, MMRV
Symptoms: Injection site erythema, Injection site induration, Injection site swelling
Clinical narrative: Right lower arm has a 50 cent size swollen red area, started on 4-6-16. On 4-7-16, left deltoid area red "size of a baseball and rock hard."  No fever.
Age: 50.0
Sex: M
Vaccine: VARZOS
Symptoms: Injection site erythema, Injection site pain, Injection site pruritus, Injection site swelling
Clinical narrative: Injection site red, swollen, itchy, sore.
Age: 50.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site erythema, Injection site pain, Injection site swelling, Injection site warmth
Clinical narrative: Injection site red, swollen, warm to touch, sore.
Age: 0.36
Sex: F
Vaccine: DTAPIPVHIB, PNC13, RV5
Symptoms: Product preparation error
Clinical narrative: Vaccine was contaminated. Was diluted with the wrong diluent.
Age: 4.0
Sex: M
Vaccine: DTAPIPV, MER
Symptoms: Accidental exposure to product
Clinical narrative: I was having grandmother of pt receiving immunizations hold his hands, as I was about to administer vaccine child started thrashing and kicking legs which resulted in grandmother being poked on leg with needle.
Age: 25.0
Sex: M
Vaccine: TDAP
Symptoms: Body temperature increased, Fatigue, Headache, Pain
Clinical narrative: Pt reported temp of 38 Celsius without using a thermometer, fatigue, headache and generalized body aches. Seen by student health MD who recommended Tylenol and rest.
Age: 4.0
Sex: F
Vaccine: DTAP, IPV, MMRV
Symptoms: Injection site rash, Rash
Clinical narrative: Rash ate site of injection as well as on arms, face, neck, back, and stomach. Rash is more prominent on cheeks and arms.
Age: 4.0
Sex: M
Vaccine: DTAPIPV, MMRV
Symptoms: Injection site discolouration, Injection site exfoliation, Injection site induration, Injection site swelling, Injection site warmth
Clinical narrative: On patient's left upper arm Area noted of approximately 4 cm in diameter, with a white dot and hole where needle entered. It was raised, scaly like in touch, and extremely hard and hot to the touch. Patient also had vomiting throughout the early morning and into afternoon.
Age: 4.0
Sex: M
Vaccine: DTAPIPV, MMRV
Symptoms: Vomiting
Clinical narrative: On patient's left upper arm Area noted of approximately 4 cm in diameter, with a white dot and hole where needle entered. It was raised, scaly like in touch, and extremely hard and hot to the touch. Patient also had vomiting throughout the early morning and into afternoon.
Age: 77.0
Sex: M
Vaccine: PNC13
Symptoms: Injection site erythema, Injection site swelling
Clinical narrative: The area on the arm around where the immunization was administered is red and looks swollen.  No infection seen.
Age: 67.0
Sex: F
Vaccine: PPV
Symptoms: Injection site erythema, Injection site pain, Injection site swelling, Pyrexia
Clinical narrative: Patient had swelling, pain and redness in injection arm.  Patient also had low grade fever.
Age: 19.0
Sex: M
Vaccine: ANTH
Symptoms: Injection site erythema, Vaccination site swelling
Clinical narrative: Swelling and redness of upper arm, around site of vaccine, extending from the deltoid to the elbow; began within 1 day of vaccine, and did not resolve for 5-7 days. No treatment required.
Age: 61.0
Sex: F
Vaccine: VARZOS
Symptoms: Chills, Injection site erythema, Injection site warmth, Pain, Pruritus
Clinical narrative: PATIENT REPORTED ERYTHEMA AT INJECTION SITE, ITCHING, LOCALIZED TENDERNESS & PAIN. INJECTION SITE WAS A TAD BIT WARM AT TOUCH. PATIENT REPORTED SLIGHT CHILLS ON 4/6/16 BUT FEELS BETTER TODAY.
Age: 61.0
Sex: F
Vaccine: VARZOS
Symptoms: Tenderness
Clinical narrative: PATIENT REPORTED ERYTHEMA AT INJECTION SITE, ITCHING, LOCALIZED TENDERNESS & PAIN. INJECTION SITE WAS A TAD BIT WARM AT TOUCH. PATIENT REPORTED SLIGHT CHILLS ON 4/6/16 BUT FEELS BETTER TODAY.
Sex: U
Vaccine: VARZOS
Symptoms: CD4 lymphocytes decreased, Contraindication to vaccination, Pruritus
Clinical narrative: It was reported in a Letter to the Editor about a patient of unknown gender, who was more than 50 years old. On an unknown date, the patient was vaccinated with a dose of zoster vaccine live (manufacturer unknown) (HZV) (lot number expiration date, dose, route were not provided). Concomitant medication was not reported. The patient was not aware of the fact that he/she was infected with Human Immunodeficiency Virus (HIV) at the time of vaccination. It was reported that the patient with CD4 count of 6 cells/uL 4 days after HZV, developed grade 3 pruritus reported as "pruritis" 96 hours after vaccination. The outcome of pruritus was unknown at the time of the report. The reporter considered pruritus to be related Zoster Vaccine Live (manufacturer unknown). This is one of two reports from the same source (US-009507513-1604USA004403). Additional information has been requested.
Age: 55.0
Sex: F
Vaccine: PPV, VARZOS
Symptoms: Activities of daily living impaired, CD4 lymphocytes increased, Inappropriate schedule of drug administration, Injection site pain, Rash
Clinical narrative: It was reported in a letter to the editor that a 55 year old female patient with HIV infection was vaccinated with influenza vaccine 3 weeks prior to Herpes Zoster Vaccine (HZV). On an unknown date, the patient with CD4 count of 455 cells/uL, was vaccinated with a dose of zoster vaccine live (manufacturer unknown) (lot number expiration date, dose, route were not provided). It was reported that pneumococcal vaccine (23-valent) (manufacturer unknown) (lot number expiration date, dose, route were not provided), was given concurrently. On an unknown date, 11 hours after HZV, the patient developed grade 3 injection site reactions (pain and tenderness, causing inability to perform activities). Then, one year after HZV, the patient developed rash consistent with dermatomal varicella zoster virus (VZV) infection and did not require hospitalization or treatment. The outcome of injection site reaction and VZV was unknown at the time of the report. The reporter considered injection site reaction and varicella virus infection to be related to Zoster Vaccine Live (manufacturer unknown). This is one of two reports from the same source (US-009507513-1604US004494).
Age: 55.0
Sex: F
Vaccine: PPV, VARZOS
Symptoms: Varicella zoster virus infection
Clinical narrative: It was reported in a letter to the editor that a 55 year old female patient with HIV infection was vaccinated with influenza vaccine 3 weeks prior to Herpes Zoster Vaccine (HZV). On an unknown date, the patient with CD4 count of 455 cells/uL, was vaccinated with a dose of zoster vaccine live (manufacturer unknown) (lot number expiration date, dose, route were not provided). It was reported that pneumococcal vaccine (23-valent) (manufacturer unknown) (lot number expiration date, dose, route were not provided), was given concurrently. On an unknown date, 11 hours after HZV, the patient developed grade 3 injection site reactions (pain and tenderness, causing inability to perform activities). Then, one year after HZV, the patient developed rash consistent with dermatomal varicella zoster virus (VZV) infection and did not require hospitalization or treatment. The outcome of injection site reaction and VZV was unknown at the time of the report. The reporter considered injection site reaction and varicella virus infection to be related to Zoster Vaccine Live (manufacturer unknown). This is one of two reports from the same source (US-009507513-1604US004494).
Age: 0.59
Sex: U
Vaccine: HIBV
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report as received from a vaccine coordinator refers to a 6 month old patient of unknown gender. On 19-FEB-2016, the patient was vaccinated with a second dose of PEDVAXHIB (Lot # L038501 exp date 16-AUG-2018) (dosage and route unknown) following a temperature excursion. No adverse effect was reported. This is one of several reports received from the same reporter. Additional information has been requested.
Age: 1.0
Sex: U
Vaccine: MMR, MMRV
Symptoms: Extra dose administered, No adverse event, Wrong drug administered
Clinical narrative: This spontaneous report was received from a nurse via company representative and refers to a 1 year old patient (unknown gender). The patient's current conditions, medical history and concomitant medications were not provided. On 29-MAR-2016, the patient as administered with PROQUAD (Merck) and M-M-R II (overdose). The patient was inadvertently administered a dose of PROQUAD (Merck) (instead of an intended dose of VARIVAX (Merck)) concomitantly with a dose of M-M-R II (wrong vaccine administered). The nurse reported that another nurse who administered the vaccines mistook PROQUAD (Merck) for VARIVAX (Merck) for an unspecified reason. No adverse effects were reported. The patient did not receive any treatment. Product quality complaint (PQC) was not involved. Additional information has been requested.
Age: 52.0
Sex: F
Vaccine: VARZOS
Symptoms: Erythema, Pain
Clinical narrative: Patient received ZOSTAVAX on Monday 4/4/16. She called the pharmacy on Thursday 4/1/16 to say she thinks she is having a reaction to the vaccine. She said it is a large red spot that is slightly painful. It did not appear until Wed night. She was told to ice it, try some BENADRYL and call her doctor. She said the size of the spot hasn't changed from Wed to Thurs.
Age: 0.17
Sex: F
Vaccine: RV5
Symptoms: Diarrhoea haemorrhagic
Clinical narrative: Bloody diarrhea - mom reported after it had resolved.
Sex: F
Vaccine: HPV9
Symptoms: Syncope
Clinical narrative: This spontaneous report was received from a Nurse practitioner referring to a female patient of unknown age. The patient's concurrent conditions and medical history were not provided. On 06-MAR-2015, the patient was vaccinated with a dose of GARDASIL 9 (strength, dose, anatomical location, lot number and expiration date were not provided). On 06-MAR-2015, the patient "fainted shortly" after receiving the dose of GARDASIL 9. The patient did not die, no laboratory tests or diagnostic procedures were performed and no treatment was given. The outcome of syncope was unknown. No product quality complaint was involved. Additional information has been requested.
Age: 18.0
Sex: M
Vaccine: MENB
Symptoms: Mobility decreased, Pain in extremity, Paraesthesia, Vaccination site pain, Wisdom teeth removal
Clinical narrative: Left arm pain in the area of vaccination started in the evening after the vaccination. The pain persists at least until the time when he was seen 4/6/16 - Her alone. Left arm is still sore from receiving BEXSERO vaccine 3/23/16. Afebrile. Had BEXSERO shot two weeks ago today in left arm. No fever or swelling noted. Started to hurt that night and has continued to hurt. Was laying around because had wisdom teeth removed. Still limited motion and pain in arm. Can't lay on that side. Occ tingling when uses it. No numbness.
Sex: M
Vaccine: VARZOS
Symptoms: Skin ulcer
Clinical narrative: This spontaneous report was received from a male patient of unknown age, who was reporting on himself. The patient's medical history, concurrent conditions and concomitant therapies were not reported. On an unknown date in October 2015 (reported as "6 months ago"), the patient was vaccinated with a dose of ZOSTAVAX (lot #, dose and route were not provided). On an unknown date in October 2015 (reported as "6 months ago"), on the next day following vaccination, the patient developed sores on his feet. The outcome of the event was not recovered. The sores did not improve and have not healed at the time of the report. The relatedness between the event and ZOSTAVAX was not reported. Additional information is not expected, as no contact details were provided.
Age: 0.2
Sex: U
Vaccine: HIBV
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report as received from a vaccine coordinator refers to a 10 week old patient of unknown gender. On 19-FEB-2016, the patient was vaccinated with a first dose of LIQUID PEDVAXHIB (lot # L030869) (dosage and route unknown) following a temperature excursion. No adverse effect was reported. This is one of several reports received from the same reporter. Additional information has been requested.
Age: 0.77
Sex: U
Vaccine: HIBV
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report as received from a vaccine coordinator refers to a 9 month old patient. On 19-FEB-2016, the patient was vaccinated with a third dose of PEDVAXHIB (lot # L030869) (dosage and route unknown) following a temperature excursion. No adverse effect was reported. This is one of several reports received from the same reporter. Additional information has been requested
Age: 42.0
Sex: M
Vaccine: HPV9
Symptoms: Burning sensation, Chest X-ray, Injection site induration, Injection site reaction, Mycobacterium tuberculosis complex test
Clinical narrative: This spontaneous report as received from a licensed practical nurse refers to a 42 year old male patient who is a physician. The patient had no pertinent medical history, drug reactions/allergies and concomitant medications. On 08-MAR-2016, patient received accidentally an unspecified dose of GARDASIL 9 (lot # L013429, expiry date 21-JUL-2017) intradermally in error (incorrect route of drug administration). The patient was indicated to receive a tuberculin (PPD), or Mantoux tuberculin skin test. The error was made because both of the products have a brown flip-cap (product packaging confusion). Since 08-MAR-2016 the patient experienced injection site reactions and reports that his arm feels like it is on fire. On an unknown date in March 2016, the patient began to develop a raised welt, which measures approximately 2 inches x 1 inch and injection site indurated 1 cm x 11 mm. It was reported that the event appears like a positive PPD test, as a result of the patient's belief that he has a positive PPD test. On 10-MAR-2016 a QuantiFERON-TB Gold test was performed whose results were not provided. On an unspecified date chest X-Ray was also done whose results were not reported. It was reported no treatment was given to the events. The reporter states that injection site looks like DTAP. The reporter also states that injection site reactions with DTAP are not common. The outcome of tuberculin test positive was reported as unknown. The outcome of other events were reported to be not recovered. Product quality complaint (PQC) was not filed. Causality assessment was not provided. Additional information has been requested.
Age: 42.0
Sex: M
Vaccine: HPV9
Symptoms: Product packaging confusion, Urticaria
Clinical narrative: This spontaneous report as received from a licensed practical nurse refers to a 42 year old male patient who is a physician. The patient had no pertinent medical history, drug reactions/allergies and concomitant medications. On 08-MAR-2016, patient received accidentally an unspecified dose of GARDASIL 9 (lot # L013429, expiry date 21-JUL-2017) intradermally in error (incorrect route of drug administration). The patient was indicated to receive a tuberculin (PPD), or Mantoux tuberculin skin test. The error was made because both of the products have a brown flip-cap (product packaging confusion). Since 08-MAR-2016 the patient experienced injection site reactions and reports that his arm feels like it is on fire. On an unknown date in March 2016, the patient began to develop a raised welt, which measures approximately 2 inches x 1 inch and injection site indurated 1 cm x 11 mm. It was reported that the event appears like a positive PPD test, as a result of the patient's belief that he has a positive PPD test. On 10-MAR-2016 a QuantiFERON-TB Gold test was performed whose results were not provided. On an unspecified date chest X-Ray was also done whose results were not reported. It was reported no treatment was given to the events. The reporter states that injection site looks like DTAP. The reporter also states that injection site reactions with DTAP are not common. The outcome of tuberculin test positive was reported as unknown. The outcome of other events were reported to be not recovered. Product quality complaint (PQC) was not filed. Causality assessment was not provided. Additional information has been requested.
Sex: U
Vaccine: HPV9
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report was received from a registered nurse regarding an unspecified number of patients of unknown age and gender. In 2016 (after 29-MAR-2016), the patients were vaccinated with improperly stored doses of GARDASIL 9 lot # L019297 with exp. 18-AUG-2017 (route and doses were not provided). The vaccines were exposed to 15C for 24 hours between 18-MAR-2016 and 29-MAR-2016. No adverse effects were reported. This is one of several reports received from the same reporter. Additional information has been requested.
Age: 13.0
Sex: F
Vaccine: HPV9
Symptoms: Headache
Clinical narrative: Patient developed headache after receiving GARDASIL 9 immun. Headache developed within 15 minutes after immunization. Patient was brought back into exam room and examined. Neuro intact. Was given TYLENOL and food. Headache.
Sex: U
Vaccine: MMR
Symptoms: Expired product administered, No adverse event
Clinical narrative: Information has been received from a healthcare student referring to a patient of unknown age and gender. There was no medical history or drug reaction reported. On 28-MAR-2106 the patient was vaccinated with a dose of MMR II (lot # L004656 with expired date 11-FEB-2017, subcutaneous), that was reconstituted with an expired dose of sterile diluent (L005460, 18-MAR-2016, subcutaneous). No concomitant therapy was reported. No adverse effect was reported. Additional information has been requested.
Age: 5.0
Sex: M
Vaccine: DTAP, IPV
Symptoms: Erythema, Local reaction, Swelling
Clinical narrative: After vaccine DTAP adm. deltoid (R) had a local reaction with swelling and redness. Resolved after a 2 days or so. Now re-occurring 'red', swelling over same site. No significant pain.
Sex: U
Vaccine: RV5
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report was received from a registered nurse regarding an unspecified number of patients of unknown age and gender. In 2016 (after 29-MAR-2016), the patients were vaccinated with improperly stored doses of ROTATEQ lot # L008034 with exp. 10-MAY-2017 and lot # L037726 with exp. 10-MAY-2017, (route and doses were not provided). The vaccines were exposed to 15C for 24 hours between 18-MAR-2016 and 29-MAR-2016. No adverse effects were reported. This is one of several reports received from the same reporter. Additional information has been requested.
Sex: U
Vaccine: RV5
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report as received from a registered nurse refers to a patient of unknown age and gender. Concurrent conditions and medical history were not reported. On 21-MAR-2016, the patient was vaccinated with an improperly stored dose of ROTATEQ (Lot # L027067, expiration date 06-APR-2017) (Dose and route were not provided). Concomitant medication was not reported. No adverse effects were reported. It was stated that excursion of temperature was 33.9F; Time frame; 6 hours; No previous temperature re excursion. It was mentioned that it was call because of a "data logger". No product complaint (PQC) was involved. Additional information has been requested.
Sex: U
Vaccine: HEP
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report was received from a registered nurse regarding an unspecified number of patients of unknown age and gender. In 2016 (after 29-MAR-2016), the patients were vaccinated with improperly stored doses of RECOMBIVAX HB lot # K010216 with exp. 10-NOV-2016 and lot # K010216 with exp. 17-SEP-2016. The vaccines were exposed to 15C for 24 hours between 18-MAR-2016 and 29-MAR-2016. No adverse effects were reported. This is one of several reports received from the same reporter. Additional information has been requested.
Sex: U
Vaccine: HIBV
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report was received from a registered nurse regarding an unspecified number of patients of unknown age and gender. In 2016 (after 29-MAR-2016), the patients were vaccinated with improperly stored doses of PEDVAXHIB lot # L014426 with exp. 14-JUN-2018 and lot # L014426 with exp. 03-AUG-2018 (doses and route were not provided). The vaccines were exposed to 15C for 24 hours between 18-MAR-2016 and 29-MAR-2016. No adverse effects were reported. This is one of several reports received from the same reporter. Additional information has been requested.
Sex: U
Vaccine: MMR
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report was received from a registered nurse regarding an unspecified number of patients of unknown age and gender. In 2016 (after 29-MAR-2016), the patients were vaccinated with improperly stored doses of M-M-R II lot # L001336 with exp. 13-JAN-2017 and lot # L023385 with exp. 25-JUN-2017 (route and doses were not provided). The vaccines were exposed to 14C for 24 hours between 18-MAR-2016 and 29-MAR-2016. No adverse effects were reported. This is one of several reports received from the same reporter. Additional information has been requested.
Age: 51.0
Sex: F
Vaccine: TDAP
Symptoms: Axillary mass, Contusion, Erythema
Clinical narrative: Patient given TDAP March 30, 2015 here today. 4/6/16 states had bad reaction pap, redness, purple bruising and lumps under arm. Here today no ss as described.
Age: 4.0
Sex: F
Vaccine: DTAPIPV, HEPA, MMR, VARCEL
Symptoms: Injection site erythema, Injection site swelling, Injection site warmth, Skin warm
Clinical narrative: 04/06/2016 Mother states right arm is red, swollen, and heat present nearly to elbow. Mom states hand is warm to touch, same as other hand. No fever and no other signs or symptoms reported.
Age: 30.0
Sex: F
Vaccine: TDAP
Symptoms: Headache, Loss of consciousness, Nausea, Vomiting
Clinical narrative: Within 20 min pt had sever N and V plus headache and blacked out - had friend drive her to ER.
Age: 11.0
Sex: F
Vaccine: HPV4, MNQ, TDAP
Symptoms: Injection site erythema, Injection site irritation
Clinical narrative: Presented with erythema mild irritation surrounding injection site (L) upper arm.
Age: 4.0
Sex: M
Vaccine: DTAPIPV, FLU4, MMRV
Symptoms: Induration, Skin warm, Swelling
Clinical narrative: Raised and warm, induration 10x10 cm.
Age: 22.0
Sex: F
Vaccine: HPV4
Symptoms: Injection site cellulitis, Injection site erythema, Injection site pain, Injection site swelling
Clinical narrative: (L) upper arm redness, swelling and pain 5 days after HPV #1 shot. Clinical diagnosis cellulitis.
Age: 13.0
Sex: F
Vaccine: HPV4
Symptoms: Hypoaesthesia, Limb discomfort, Paraesthesia
Clinical narrative: Pt was given HPV immun. Walked to lobby then c/o numbness and tingling to (R) arm. Was brought back to clinic. BP checked 103/60. Pt was checked by NP. Could move all fingers, good grip, complete ROM. After felt pinch, states "now in top of arm and part in lower arm". Pt/mom left and was phoned later and mom said about 30 min after leaving clinic, arm was fine.
Age: 74.0
Sex: F
Vaccine: UNK
Symptoms: Myalgia
Clinical narrative: Pt. states she has muscle aches in the arms and knees from the vaccines.
Age: 68.0
Sex: M
Vaccine: VARZOS
Symptoms: Injection site erythema, Injection site papule, Papule, Varicella
Clinical narrative: Patient developed red marks and papules around injection site, then spread all over the body. Patient went to physician and was diagnosed with chicken pox.
Age: 75.0
Sex: F
Vaccine: PPV
Symptoms: Injection site erythema, Injection site pain, Local swelling, Mobility decreased, Musculoskeletal pain
Clinical narrative: 4:00 PM the site burned and hurt. 8:00 PM very red. I put ice on it and took TYLENOL. During the night, my shoulder, arm, and neck were quite painful. My arm and neck were swollen. 3/20/16 8:00 AM - arm was red from shoulder to elbow and swollen and painful. I took TYLENOL every 4 hrs. Difficulty moving arm. 3-21-16 arm red, hurting and difficulty moving. 3-22-16 - No redness but arm was sore and tender. 3-23-16 just soreness. I have never had an adverse event from any vaccine before this and I've had the pneumonia and pneu.
Age: 75.0
Sex: F
Vaccine: PPV
Symptoms: Neck pain, Pain in extremity, Peripheral swelling, Tenderness
Clinical narrative: 4:00 PM the site burned and hurt. 8:00 PM very red. I put ice on it and took TYLENOL. During the night, my shoulder, arm, and neck were quite painful. My arm and neck were swollen. 3/20/16 8:00 AM - arm was red from shoulder to elbow and swollen and painful. I took TYLENOL every 4 hrs. Difficulty moving arm. 3-21-16 arm red, hurting and difficulty moving. 3-22-16 - No redness but arm was sore and tender. 3-23-16 just soreness. I have never had an adverse event from any vaccine before this and I've had the pneumonia and pneu.
Age: 30.0
Sex: M
Vaccine: PPV, TD
Symptoms: Injection site erythema, Local reaction, Vaccination site swelling, Vaccination site warmth
Clinical narrative: Patient developed a warm red and swollen local reaction within one day of vaccination - at vaccination site. No respiratory symptoms.
Age: 34.0
Sex: F
Vaccine: TDAP
Symptoms: Eye swelling, Lip swelling, Rash
Clinical narrative: Rash on hands, feet, shoulders, and collarbone. Swelling in eyes, lips, and bra line. Incident stared 3 hours after receiving injection.
Age: 74.0
Sex: M
Vaccine: FLU3, PPV
Symptoms: Chills, Injection site erythema, Injection site pain, Ultrasound scan
Clinical narrative: 3-3-16 PNEUMOVAX and FLUZONE given on left deltoid. In evening chills. 3-4-16 sore, red and painful at injection site. 3-5-16 went to immediate care. Pt given ultrasound then rx for KEFLEX.
Age: 16.0
Sex: F
Vaccine: MENB
Symptoms: Drug administered to patient of inappropriate age, No adverse event
Clinical narrative: Pt. waited 15 min no reaction.
Age: 68.0
Sex: M
Vaccine: PNC13
Symptoms: Injection site erythema
Clinical narrative: Pt. came in Tuesday 4/5/16, stating he had a red area where he previously had vaccine given. He showed me a quarter, sized red area at that time and he was advised to seek medical attention if it got any bigger or didn't go down. The next day, it had gotten worse so he went to MD and was given AUGMENTIN x 7 days.
Age: 44.0
Sex: F
Vaccine: FLU3, PPV
Symptoms: Cellulitis, Gastric disorder, Injection site pain, Injection site swelling
Clinical narrative: Case number PHHY2016US026987 is a spontaneous report initially received via Vaccine Adverse Events Reporting System (VAERS reference number: 609936) on 29 Feb 2016. This report refers to a 44 year old female patient. She had no medical history or current conditions. Her concomitant medications were not reported. She was vaccinated with FLUVIRIN (batch number: 158303, expiry date: 30 Jun 2016) and PNEUMOVAX (other manufacturer, batch number: L035687); both vaccines administered intramuscularly in the left arm on 13 Nov 2015. On 14 Nov 2015, the patient had swelling and pain in the site of injections of the left arm and gastric distress. The patient went to emergency room and was diagnosed with cellulitis. Laboratory tests were not reported. The events outcome was unknown. The events were reported as non-serious, but the event cellulitis was upgraded as medically significant based on the NVS-IME list. The causality of the events was not reported. Based on the documents review, it was concluded that the FLUVIRIN batch 158303 was manufactured in accordance with the approved internal procedures and it was in compliance with the cGMP requirements. No anomalies were noted during this review. Non significant follow up received via quality assurance department (QA reference number: 1012887) on 03 Mar 2015: QA number updated. Follow up information received via quality assurance department on 04 Apr 2016: Batch summary updated.
Age: 50.0
Sex: M
Vaccine: FLU3, PPV
Symptoms: Cellulitis, Erythema, Feeling hot, Pain in extremity, Peripheral swelling
Clinical narrative: Case number PHHY2016US029825, is an initial spontaneous report received from the Vaccine Adverse Event Reporting System (VAERS reference number: 610080) website on 29 Feb 2016. This report refers to a 50-years-old male patient. Past medical history and concomitant medications were not reported. The patient was vaccinated with FLUVIRIN (batch number: 1516501) intramuscularly and first dose of PNEUMOVAX (manufacturer unknown, batch number: L024132) intramuscularly both received on 04 Nov 2015. On the same day, after vaccination the patient experienced cellulitis in left arm, pain, swelling, heat and streaking 4 in 24 hours. The patient was treated with ROCEPHIN intramuscularly and KEFLEX per oral. The patient visited the emergency room. Outcome of the events was not reported. Seriousness of the events was reported as non serious and causality of the events was not reported. Seriousness of the events pain, swelling and feeling hot was upgraded to medically significant based on the information available in the source document. The seriousness of the event cellulitis was upgraded to medically significant based on the Novartis important Medical Event list. Batch review report (QA reference number: 1012975) received from quality assurance department on 04 Apr 2016: Based on the document review, it was stated that the concerned FLUVIRIN, batch number: 1516501, was manufactured in accordance with approved internal procedures and it was in compliance with the current good manufacturing practices (cGMP) requirements. Non significant follow up received via quality assurance department (QA reference number: 1012975) on 07 Mar 2016: QA number updated. Significant follow up report received from Quality Assurance Department (QA reference number: 1012975) on 04 Apr 2016: Updated batch review report (conclusion added).
Age: 50.0
Sex: M
Vaccine: FLU3, PPV
Symptoms: Skin discolouration
Clinical narrative: Case number PHHY2016US029825, is an initial spontaneous report received from the Vaccine Adverse Event Reporting System (VAERS reference number: 610080) website on 29 Feb 2016. This report refers to a 50-years-old male patient. Past medical history and concomitant medications were not reported. The patient was vaccinated with FLUVIRIN (batch number: 1516501) intramuscularly and first dose of PNEUMOVAX (manufacturer unknown, batch number: L024132) intramuscularly both received on 04 Nov 2015. On the same day, after vaccination the patient experienced cellulitis in left arm, pain, swelling, heat and streaking 4 in 24 hours. The patient was treated with ROCEPHIN intramuscularly and KEFLEX per oral. The patient visited the emergency room. Outcome of the events was not reported. Seriousness of the events was reported as non serious and causality of the events was not reported. Seriousness of the events pain, swelling and feeling hot was upgraded to medically significant based on the information available in the source document. The seriousness of the event cellulitis was upgraded to medically significant based on the Novartis important Medical Event list. Batch review report (QA reference number: 1012975) received from quality assurance department on 04 Apr 2016: Based on the document review, it was stated that the concerned FLUVIRIN, batch number: 1516501, was manufactured in accordance with approved internal procedures and it was in compliance with the current good manufacturing practices (cGMP) requirements. Non significant follow up received via quality assurance department (QA reference number: 1012975) on 07 Mar 2016: QA number updated. Significant follow up report received from Quality Assurance Department (QA reference number: 1012975) on 04 Apr 2016: Updated batch review report (conclusion added).
Age: 60.0
Sex: F
Vaccine: FLU3, VARZOS
Symptoms: Cellulitis, Erythema, Pain, Skin warm, Swelling
Clinical narrative: Case number PHHY2016US027177, is an initial spontaneous report received Vaccine Adverse Event Reporting System (VAERS reference number: 614840) website on 29 Feb 2016. This case also contains QA reference number: 1012974. This report refers to a 60 years old female patient. Past medical history and concomitant medications were not reported. The patient was vaccinated with FLUVIRIN (batch number: 157604) into left arm, intramuscularly on 11 Dec 2015. The patient also vaccinated with ZOSTAVAX vaccine (other manufacturer, batch number: L028281) into right arm, subcutaneously on 11 Dec 2015. On 12 Dec 2015, the patient experienced red, painful, raised area and warm to the touch for 03 days. The patient went to walk in clinic on 14 Dec 2015 and diagnosis cellulitis secondary to injection. The patient prescribed with KEFLEX 500 mg at dose of 1 TID for 10 day. The outcome of the events was reported as complete recovery on an unknown date. The seriousness of the events was reported as non serious. The causality of the events was not reported. The seriousness assessment of cellulitis was upgraded to medically significant based on the NVS IME list. Batch review report (reference number (1012974) received from quality assurance department 0n 05 Apr 2016: Based on the document review, it was stated that the concerned FLUVIRIN batch number (157604) was manufactured in accordance with approved internal procedures and it was in compliance with the current good manufacturing practices (cGMP) requirements. Non significant follow up report from the QA department (QA reference number: 1012974) received on 07 Mar 2016: Updated QA reference number only. Significant follow up information received from the QA department on 05 Apr 2016: Added QA summary.
Age: 20.0
Sex: M
Vaccine: FLU3, FLU3
Symptoms: Balance disorder, Central nervous system inflammation, Computerised tomogram, Constipation, Hypoaesthesia
Clinical narrative: Case number PHHY2016US041531, is an initial spontaneous report received from the Vaccine Adverse Event Reporting System (VAERS reference number: 619502) website on 29 Mar 2016. This report refers to a 20-years-old male patient. Past medical history and concomitant medications were not reported. The patient was vaccinated with FLUVIRIN (batch number: 66521011702) intramuscularly in arm on 27 Jan 2015. On 12 Feb 2015, the patient experienced numbness from bottom to left foot and from knee to foot and he was unable to keep overall body balance. He experienced constipation and could not control bladder. On an unknown date the laboratory data revealed spinal cord inflammation. Magnetic resonance imaging (MRI) of brain flare and computer tomography (CT) performed on an unknown date and results were unspecified. It was also reported that, magnetic resonance imaging (MRI) of thorax was pending due to delay in medical insurance procedures. The patient visited the emergency room. The outcome of the events was reported as condition unchanged. The seriousness of the events was reported as serious (reported as permanent disability). The causality of the events was not reported. Upon follow the Quality Assurance department reported that, the standard QA investigation 1013993 was cancelled on the basis that no valid batch number was provided. Follow up report received from Quality Assurance department on 06 Apr 2016: Updated QA comments.
Age: 20.0
Sex: M
Vaccine: FLU3, FLU3
Symptoms: Nuclear magnetic resonance imaging brain, Nuclear magnetic resonance imaging thoracic, Urinary incontinence
Clinical narrative: Case number PHHY2016US041531, is an initial spontaneous report received from the Vaccine Adverse Event Reporting System (VAERS reference number: 619502) website on 29 Mar 2016. This report refers to a 20-years-old male patient. Past medical history and concomitant medications were not reported. The patient was vaccinated with FLUVIRIN (batch number: 66521011702) intramuscularly in arm on 27 Jan 2015. On 12 Feb 2015, the patient experienced numbness from bottom to left foot and from knee to foot and he was unable to keep overall body balance. He experienced constipation and could not control bladder. On an unknown date the laboratory data revealed spinal cord inflammation. Magnetic resonance imaging (MRI) of brain flare and computer tomography (CT) performed on an unknown date and results were unspecified. It was also reported that, magnetic resonance imaging (MRI) of thorax was pending due to delay in medical insurance procedures. The patient visited the emergency room. The outcome of the events was reported as condition unchanged. The seriousness of the events was reported as serious (reported as permanent disability). The causality of the events was not reported. Upon follow the Quality Assurance department reported that, the standard QA investigation 1013993 was cancelled on the basis that no valid batch number was provided. Follow up report received from Quality Assurance department on 06 Apr 2016: Updated QA comments.
Age: 20.0
Sex: M
Vaccine: FLU3, FLU3
Symptoms: Balance disorder, Central nervous system inflammation, Constipation, Hypoaesthesia, Nuclear magnetic resonance imaging brain
Clinical narrative: Case number PHHY2016US041531, is an initial spontaneous report received from the Vaccine Adverse Event Reporting System (VAERS reference number: 619502) website on 29 Mar 2016. This report refers to a 20-years-old male patient. Past medical history and concomitant medications were not reported. The patient was vaccinated with FLUVIRIN (batch number: 66521011702) intramuscularly in arm on 27 Jan 2015. On 12 Feb 2015, the patient experienced numbness from bottom to left foot and from knee to foot and he was unable to keep overall body balance. He experienced constipation and could not control bladder. On an unknown date the laboratory data revealed spinal cord inflammation. Magnetic resonance imaging (MRI) of brain flare and computer tomography (CT) performed on an unknown date and results were unspecified. It was also reported that, magnetic resonance imaging (MRI) of thorax was pending due to delay in medical insurance procedures. The patient visited the emergency room. The outcome of the events was reported as condition unchanged. The seriousness of the events was reported as serious (reported as permanent disability). The causality of the events was not reported. Upon follow the Quality Assurance department reported that, the standard QA investigation 1013993 was cancelled on the basis that no valid batch number was provided. Follow up report received from Quality Assurance department on 06 Apr 2016: Updated QA comments.
Age: 20.0
Sex: M
Vaccine: FLU3, FLU3
Symptoms: Nuclear magnetic resonance imaging thoracic, Urinary incontinence
Clinical narrative: Case number PHHY2016US041531, is an initial spontaneous report received from the Vaccine Adverse Event Reporting System (VAERS reference number: 619502) website on 29 Mar 2016. This report refers to a 20-years-old male patient. Past medical history and concomitant medications were not reported. The patient was vaccinated with FLUVIRIN (batch number: 66521011702) intramuscularly in arm on 27 Jan 2015. On 12 Feb 2015, the patient experienced numbness from bottom to left foot and from knee to foot and he was unable to keep overall body balance. He experienced constipation and could not control bladder. On an unknown date the laboratory data revealed spinal cord inflammation. Magnetic resonance imaging (MRI) of brain flare and computer tomography (CT) performed on an unknown date and results were unspecified. It was also reported that, magnetic resonance imaging (MRI) of thorax was pending due to delay in medical insurance procedures. The patient visited the emergency room. The outcome of the events was reported as condition unchanged. The seriousness of the events was reported as serious (reported as permanent disability). The causality of the events was not reported. Upon follow the Quality Assurance department reported that, the standard QA investigation 1013993 was cancelled on the basis that no valid batch number was provided. Follow up report received from Quality Assurance department on 06 Apr 2016: Updated QA comments.
Age: 0.36
Sex: F
Vaccine: DTAPIPVHIB, PNC13, RV5
Symptoms: Culture urine positive, Dehydration, Differential white blood cell count, Full blood count, Metabolic function test
Clinical narrative: Fever to 102.7. Vomiting and dehydration no diarrhea.
Age: 0.36
Sex: F
Vaccine: DTAPIPVHIB, PNC13, RV5
Symptoms: Pyrexia, Urinary tract infection, Urine analysis, Vomiting
Clinical narrative: Fever to 102.7. Vomiting and dehydration no diarrhea.
Age: 26.0
Sex: F
Vaccine: HEP
Symptoms: Biopsy heart, Cardiogenic shock, Donor specific antibody present, Transplant rejection
Clinical narrative: This literature marketed report was obtained from published literature article as stated above and refers to a 26 years old female patient. The patient's medical history included double heart valve replacement. The patient was 0% HLA class I, only 12% sensitized to HLA-class II, and the virtual crossmatch against her donor was negative. As an inpatient for 3 weeks prior to transplant, the clinical team was able to report she had not incurred any sensitizing events. On an unspecified date, protocol fresh frozen plasma and hepatitis B vaccine (recombinant) (manufacturer unknown) were given to the patient. Flow crossmatch (FCXM) on the 1 month pre-transplant sample was negative, correlating with the original virtual. During the transplant, testing of the immediate pre-transplant sample revealed the patient was 100% sensitized to HLA-Class I and 24% to Class II, FCXM on the same sample showed strong T and B cell channel shifts, HIA-DSA titered as high as 1:512 and were strongly C1q-binding. This was a surprising increase from results collected one month prior to transplant. The clinical transplant team was alerted, and while the patient was fine at that time, within 5 hours of transplant, cardiogenic shock and rejection began. Early detection of sensitization allowed the transplant team to arrange for plasmapheresis (PP) antilymphocyte immunoglobulin (thymoglobulin) and eculizumab before the patient crashed. DSAs responded quickly to eculizumab, bortezomib and PP. Within 4 days post-transplant, DSA titers had fallen to 1:8, and a 1 week post-transplant right atrium biopsy was C4d negative. This was the most rapid response to therapy that had ever seen, and speculated that the hyperacute immune response and quick therapy, including PP and complement inhibitors, precluded a mature complement response and C4d deposition. As of 4 months post-transplant, DSA titers were maintained below 1:4 on tacrolimus, CELLCEPT and prednisone, and the patient entered cardio rehabilitation. While likely an anamnestic response pointing to a gap in HLA-specificity data collection, perhaps immunization could have served as a sensitizing event in this case. This case highlights the need for close monitoring for HLA-sensitizing and antibody specificity changes following hospitalization and vaccination. The outcome of cardiogenic shock and transplant rejection was recovering. The reporter considered cardiogenic shock and transplant rejection to be related to hepatitis B vaccine (Recombinant) (manufacturer unknown). The reporter considered the events, cardiogenic shock and transplant rejection as serious due to hospitalization. Upon internal review, cardiogenic shock was also determined to be other medically significant. Additional information has been requested.
Sex: M
Vaccine: VARZOS
Symptoms: Adverse reaction
Clinical narrative: Information has been received from a physician via a company representative referring to a currently 68 years old male patient. On an unknown date the patient was vaccinated with a dose of ZOSTAVAX (dose, frequency were not reported). On an unknown date the patient developed a severe reaction and needed to be hospitalized. The patient was expected to go in and see the Doctor for a follow up in 2 weeks. The outcome of the event was unknown. Causality was not reported. Additional information has been requested.
Age: 0.34
Sex: M
Vaccine: DTAPIPVHIB, PNC13, RV5
Symptoms: Coagulation test normal, Full blood count normal, Haematemesis, Melaena, Stool analysis normal
Clinical narrative: New onset of one episode of hematemesis and melena x 36 hours.  Symptoms then resolved.
Age: 4.0
Sex: F
Vaccine: DTAP
Symptoms: Diarrhoea, Vomiting
Clinical narrative: Started with vomiting. After 4-6 hours diarrhea began. Both have continued for about 36 hours now.
Age: 0.17
Sex: M
Vaccine: DTAPIPVHIB, HEP, PNC13, RV5
Symptoms: Constipation, Discomfort, Irritability, X-ray normal
Clinical narrative: Immunizations given 2/4/16, no bowel movement, 2/8 mom did a suppository infant fussy, uncomfortable. (Prior to shots infant went with every feeding, breastfed) on day 11 2/15/16 seen Dr. had X-ray; suppository on Day 15 which was 2/19/16 another X-ray was taken. 2/22 thru 2/26 suppository daily; infant now takes 2 oz of juice a day, mom only assist 2 times a month with suppository.
Age: 0.25
Sex: M
Vaccine: DTAPIPVHIB, PNC13, RV5
Symptoms: Abdominal X-ray, Constipation, Hypophagia, Ultrasound abdomen, Urine output decreased
Clinical narrative: Decreased PO intake, poor UOP, no BM, vomiting.
Age: 0.25
Sex: M
Vaccine: DTAPIPVHIB, PNC13, RV5
Symptoms: Vomiting
Clinical narrative: Decreased PO intake, poor UOP, no BM, vomiting.
Age: 2.0
Sex: M
Vaccine: FLU3, FLUX
Symptoms: Pyrexia, Seizure
Clinical narrative: Fever and seizure.
Age: 2.0
Sex: M
Vaccine: FLU3, FLUX
Symptoms: Febrile convulsion
Clinical narrative: Fever and seizure.
Age: 51.0
Sex: M
Vaccine: FLU4, PPV, PPV
Symptoms: Injection site pain, Injection site warmth, Vaccination site pain, Vaccination site swelling
Clinical narrative: Pneumovax 23 (lot # L012215) was administered on 10/6/15 by SC injection in the right arm. Additionally, influenza vaccine (Fluzone, Lot #UI439AB) was given on 10/6/15 as an IM injection also in the Right arm. Patient has complaint of pain and swelling at pneumonia vaccine site on arm. Injection site is tender, and warm to the touch.
Age: 51.0
Sex: M
Vaccine: FLU4, PPV, PPV
Symptoms: Unevaluable event
Clinical narrative: Pneumovax 23 (lot # L012215) was administered on 10/6/15 by SC injection in the right arm. Additionally, influenza vaccine (Fluzone, Lot #UI439AB) was given on 10/6/15 as an IM injection also in the Right arm. Patient has complaint of pain and swelling at pneumonia vaccine site on arm. Injection site is tender, and warm to the touch.
Age: 65.0
Sex: F
Vaccine: FLU3, PPV
Symptoms: Erythema, Injection site pain, Skin warm, Swelling
Clinical narrative: Nursing note on 10/7 @ 0800 states Pt's pneumonia vaccine site on the Left arm appears to be red, slightly swollen, and hot to touch. Pt does not complain of any pain at the site, and refused an ice pack. No further orders.
Age: 4.0
Sex: M
Vaccine: DTAPIPV, MMR
Symptoms: Ecchymosis, Injection site bruising, Injection site discomfort, Injection site erythema, Injection site swelling
Clinical narrative: Redness and swelling of right deltoid, with discomfort and bruising, worsening 2 days after immunization, then starting to improve. Residual redness 6cm diameter and 4-5 cm ecchymosis, with improved symptoms 3 days after immunization.
Age: 41.0
Sex: M
Vaccine: TDAP
Symptoms: Diarrhoea, Dizziness, Feeling cold, Nausea, Pain in extremity
Clinical narrative: Pt had her Tdap done on Monday, 3/28/16 at 4:30 and was given Amoxicillin. That night she felt lightheaded and nausea, she had chills and fever and her arm was hurting.  She developed nausea, vomiting and diarrhea.  Her medication was changed to Zpak yesterday. She cannot lift her arm at all. No redness though swelling present at the site.