chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 0.19
Sex: F
Vaccine: DTAPHEPBIP, HIBV, PNC13, RV5
Symptoms: Respiratory rate decreased, Underdose, Unresponsive to stimuli
Clinical narrative: 0925 The pt was here for vaccination. 0930 Pt alert, active & responsive, then nurse started giving Rotavirus (R.V.) orally. Nurse gave R.V. about 2 drops at a time. 0935 After giving 3/4 dose of R.V., the pt started coughing & spitted out small amount of clear liquid. Pt's mother held upright & patted the pt's back. Pt spitted out small amount of clear liquid. Pt looked lethargic, no response to stimulatiion, weak pulse & slow respiration, lips pinkish & skin warm to touch. 0940am informed clinician. Clinician came & assessed the pt's condition. Nurse continued to stimulate pt. 0942 Pt opened both eyes, awake, active & response to mother. Clinician continued to assess pt. Clinician advised no need to give the remaining of R.V. vaccine & just to give the other vaccines today & carred. 0955 PCV13, Pediarix & HIB IM given & pt tolerated well. Instructed pt's mother to stay in the clinic for 15 minutes to monitor for adverse reaction. 1010 nurse assessed pt without any adverse reaction noted. Pt was bottle feeding. 1018 pt's mother & pt left the clinic without notifed nurse.
Age: 38.0
Sex: F
Vaccine: FLU4
Symptoms: Contusion, Joint range of motion decreased, Local swelling, Pain in extremity
Clinical narrative: Swelling, bruising, soreness in the arm, still do not have full range of motion left arm.
Age: 54.0
Sex: F
Vaccine: FLUX, PNC13
Symptoms: Asthenia, Chills, Cold sweat, Erythema, Fatigue
Clinical narrative: Arm hurting within 30 minutes then very bad pain in right leg by noon. Then both arms and the other leg like pulled muscle, worst in right leg. Chills, cold sweat, both cheeks on face very red and very hot. Nothing helped with the pain and lasted for 2 days and nights and then still feeling really bad all over, redness still on cheeks, very weak for over a week like I had no strength in my legs and got tired very easily for a long time. I was also very pale and still have aches and weakness off and on.
Age: 54.0
Sex: F
Vaccine: FLUX, PNC13
Symptoms: Myalgia, Pain in extremity, Pallor, Skin warm
Clinical narrative: Arm hurting within 30 minutes then very bad pain in right leg by noon. Then both arms and the other leg like pulled muscle, worst in right leg. Chills, cold sweat, both cheeks on face very red and very hot. Nothing helped with the pain and lasted for 2 days and nights and then still feeling really bad all over, redness still on cheeks, very weak for over a week like I had no strength in my legs and got tired very easily for a long time. I was also very pale and still have aches and weakness off and on.
Age: 27.0
Sex: F
Vaccine: FLU4
Symptoms: Chest discomfort, Electrocardiogram normal
Clinical narrative: Heaviness and soreness in central upper chest. No shortness of breath, wheezing, rash, or fever.
Age: 51.0
Sex: M
Vaccine: FLUX
Symptoms: Erythema, Local swelling, Pain, Pyrexia
Clinical narrative: Arm swollen and red, initially 3x3 inch circle.  Entire body aches and pains.  Fever. Symptoms lasted until 12/08/2014 6:00 AM. Arm swelling continued to worsen to 6X7 inch area by 12/08.2014 21:00 PM.
Age: 32.0
Sex: M
Vaccine: ANTH, JEV1, MNQ, TYP
Symptoms: Headache, Influenza like illness, Pain, Urticaria
Clinical narrative: Awoke with flu-like feeling, body aches, headache, few scattered small round hives on the elbow/wrist and around waist.
Age: 31.0
Sex: F
Vaccine: FLU3, PPV
Symptoms: Erythema, Inflammation, Local swelling, Pain in extremity, Vomiting
Clinical narrative: Swelling of arm. Pain; Redness and inflammation of arm. Vomiting.
Age: 16.0
Sex: F
Vaccine: FLUN4
Symptoms: Dyspnoea, Pruritus
Clinical narrative: Patient had itching to her face, neck, legs. She had difficulty breathing 1130 am, EPIPEN 0.3 mg given at 1150 am (R) outer thigh.
Age: 15.0
Sex: M
Vaccine: FLU4, HPV4
Symptoms: Blood urine present, Dysuria, Epistaxis, Pain, Pyrexia
Clinical narrative: Pt. started fever, body ache and pain on urination and blood in the urine on 11/13/14. Pt. was seen at ER on 11/13/14 night and was admitted at hospital from 11/14/14-11/16/14. Pt. is still being followed up by Nephrologist. Pt. still has blood in the urine and now has bleeding from the nose - started on 12/6/2014.
Age: 58.0
Sex: F
Vaccine: FLUX
Symptoms: Local swelling, Pruritus, Urticaria
Clinical narrative: Urticaria pruritus and swelling of arm.
Age: 0.5
Sex: M
Vaccine: DTAP, FLU3, HEPA, HIBV, IPV, PNC13, RV5
Symptoms: Accidental exposure to product
Clinical narrative: 6 month old boy was accidentally given hepatitis A vaccine by MA's miscommunication and careless.
Age: 77.0
Sex: M
Vaccine: FLU3
Symptoms: Rash generalised
Clinical narrative: Broke out in body rash, no other new meds or environmental changes.
Age: 4.0
Sex: M
Vaccine: DTAP, FLU3, IPV
Symptoms: Eye swelling, Eyelid oedema, Pruritus, Rash erythematous, Rash generalised
Clinical narrative: Patient went home and soon after arrival had severe itching and parent noted rash over body which was red and blotchy-was about 1 hr to 1 1/2 hr after shot, then eyelid swelling. BENADRYL given x 2 and rash improved on way to E.R.
Age: 4.0
Sex: M
Vaccine: DTAP, FLU3, IPV
Symptoms: Rash macular, Urticaria
Clinical narrative: Patient went home and soon after arrival had severe itching and parent noted rash over body which was red and blotchy-was about 1 hr to 1 1/2 hr after shot, then eyelid swelling. BENADRYL given x 2 and rash improved on way to E.R.
Age: 51.0
Sex: F
Vaccine: FLU3, PPV
Symptoms: Local swelling, Skin warm, Tenderness
Clinical narrative: Left arm swollen, red, tender, hot. MD wrote a script for AUGMENTIN in case of infection.
Sex: U
Vaccine: RV5
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report as received from a nurse refers to unknown number of patients of unknown ages and gender. On unknown dates the patients were vaccinated with improperly stored ROTATEQ (strength, dosage, frequency and route unknown). No adverse effects reported. This is one of several reports received from the same reporter. Additional information is not expected because the reporter did not want to be contacted.
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. On an unknown date, the patient was vaccinated with a dose of improperly stored ROTATEQ (2 ml, oral, lot number and expiration date were not reported). No adverse effects were reported. Additional information has been requested.
Age: 25.0
Sex: F
Vaccine: MMR, VARCEL, MMR, VARCEL
Symptoms: Erythema, Pain in extremity, Peripheral swelling
Clinical narrative: Red warm painful over left deltoid injection site.
Age: 25.0
Sex: F
Vaccine: MMR, VARCEL, MMR, VARCEL
Symptoms: Injection site erythema, Injection site pain, Injection site warmth
Clinical narrative: Red warm painful over left deltoid injection site.
Sex: U
Vaccine: MMRV
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: Information was received from a registered nurse concerning an unspecified number of patients (demographics not provided). On unknown dates, 15 doses of improperly stored PROQUAD (Merck) (dosage and route of administration not provided) were administered to an unspecified number of patients. No adverse symptoms were reported. The temperature excursion for PROQUAD (Merck) as found to be supported with in-house stability. date. This is one of two reports from the same reporter. Additional information has been requested.
Sex: U
Vaccine: VARCEL
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: Information was received from a registered nurse concerning an unspecified number of patients (demographics not provided). On unknown dates, 10 doses of improperly stored VARIVAX (Merck) (dosages and routes of administration not provided) were administered to an unspecified number of patients. No adverse symptoms were reported. The temperature excursion for VARIVAX (Merck) was found to be supported with in-house stability data. This is one of two reports from the same reporter. Additional information has been requested.
Sex: U
Vaccine: PPV
Symptoms: Inappropriate schedule of drug administration, No adverse event
Clinical narrative: Information was received from a pharmacist concerning an unspecified number of patients (demographics not provided). The pharmacist reported that an unspecified number of unspecified patients are "routinely revaccinated with PNEUMOVAX-23 every 5 years" (dates of vaccination, dosages and routes of administration not provided). No adverse effect reported. Additional information has been requested.
Age: 60.0
Sex: M
Vaccine: VARZOS
Symptoms: Mobility decreased, Peripheral nerve palsy
Clinical narrative: Pt experienced limited mobility of fingers and upper hand exactly five weeks post immunization. MD walk in visit r/o TIA, CVA. Orthopedic MD visit on 12/5 diagnosed problem as peripheral nerve palsy.
Age: 62.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site erythema, Injection site pain, Injection site warmth
Clinical narrative: Information was received from a pharmacist concerning a 62 year old female patient. On 12-NOV-2014, the patient was vaccinated with a single dose (unspecified amount) of ZOSTAVAX (lot # K009199, expiration date 27-SEP-2015), subcutaneously in the left arm. On 14-NOV-2014, the patient developed a 3-4 inch painful area of redness and warmth at the injection site and went to the pharmacy. The pharmacist suggested the patient apply cool compresses to the area of reaction and to take ibuprofen as needed for pain. The pharmacist requested a lot check. The outcome of developed 3-4 inch painful area of redness and warmth at the injection site was reported as recovering. This is one of 2 reports for this reporter. Additional information has been requested.
Age: 71.0
Sex: M
Vaccine: VARZOS
Symptoms: Flushing, Rash, Throat tightness
Clinical narrative: Skin rash and throat tightness, flushing of face.
Sex: U
Vaccine: HEP
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report as received from a Medical Assistant refers to an unspecified number of patients of unknown age and gender. On an unknown date the unspecified number unspecified patients were vaccinated with unspecified doses of improperly stored RECOMBIVAX HB injection (lot number not provided) (strength, dose, frequency and route not provided). No adverse effect was reported. The outcome of event was not reported. This is one of 4 reports from the same source. Additional information has been requested.
Age: 2.0
Sex: M
Vaccine: DTAP
Symptoms: Crying, Pyrexia, Vomiting projectile
Clinical narrative: Pt. had a large projectile emesis 24 hours after shot. At exactly 48h after pt. had nonstop inconsolable crying and low grade temp 100.3 all day.
Sex: U
Vaccine: HPV4
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report as received from a certified medical assistant refers to an unspecified number of patients of unknown age and gender. Information about concurrent conditions, concomitant medication and medical history was not provided. After the improper storage reported as 04-SEP-2014, on unspecified date(s) of 2014, the patients were vaccinated with 4 doses of improperly stored GARDASIL (lot#, dose, route and frequency were not provided). No adverse event was reported. This is one of several reports received from the same source. Additional information has been requested.
Sex: U
Vaccine: PPV
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report as received from a certified medical assistant refers to a patient of unknown age and gender. Information about concurrent conditions, concomitant medication and medical history was not provided. After the improper storage reported on 04-SEP-2014, on an unspecified date of 2014, the patient was vaccinated with one dose of improperly stored PNEUMOVAX 23 (injection, lot#, dose, route and frequency were not provided). No adverse event was reported. This is one of several reports received from the same source. Additional information has been requested.
Age: 13.0
Sex: F
Vaccine: VARCEL
Symptoms: Antibody test negative, Inappropriate schedule of drug administration
Clinical narrative: This spontaneous report as received from a pharmacist refers to a 13 year old (currently 16 year old) female patient with Crohn's disease and no drug allergy. The patient was not pregnant. The pharmacist reported that the patient received the 1st dose of VARIVAX (Merck) (lot#, dose and route unknown) "when she was little" and the 2nd dose of VARIVAX (Merck) (lot#, dose and route unknown) "when she was 13 years old (in approximately 2011)". Concomitant therapies included prednisone(manufacturer unknown, route default as oral). The patient had blood drawn on an unspecified "recent" date (in approximately 2014) which showed she had negative anti-varicella antibody titers (date unknown). No treatment given to the event. The outcome of negative anti-varicella antibody titers was unknown. No PQC (Production Quality Control) involved. Additional information is not expected since the pharmacist asked not to contact the physician.
Sex: F
Vaccine: PPV
Symptoms: Rash
Clinical narrative: This spontaneous report as received from a female consumer of unknown age. No information provided regarding medical history and concurrent conditions. On an unknown date of 2009, the patient was vaccinated with first dose of PNEUMOVAX23. On an unknown date of 2014, the patient had vaccinated with second dose of PNEUMOVAX23 (route, lot#, dose not reported). No concomitant medications reported. It was reported that on an unknown date of 2009 the patient was vaccinated with PNEUMOVAX23 he did not experience any bad reactions to it. After the second dose of vaccination with PNEUMOVAX23 the patient had developed rash. The event was treated with BENADRYL (dosage/frequency/manufacturer unknown). The outcome of recently received a second dose and developed rash was unknown. Additional information is not expected. The patient did not wish to provide specific information.
Age: 19.0
Sex: F
Vaccine: HEP
Symptoms: Drug administered to patient of inappropriate age, No adverse event
Clinical narrative: This spontaneous report was received from a licensed nursing practitioner refers to a 19 year old female patient. No relevant medical history of the patient was reported. The patient on 02-MAY-2002, 30-MAY-2002 and 12-DEC-2002 received unspecified Hepatitis B vaccine (manufacturer unknown) (lot number, expiry date, strength and route of administration were unknown). Thimerosal content was unknown. There were no concomitant medications reported. It was reported that the patient had indeterminate antibodies for Hepatitis B, as detected by a test on an unspecified date. The reporting nurse did not have the lot numbers of the unspecified Hepatitis B vaccine (manufacturer unknown) because they were administered at another practice. On 18-NOV-2014 the patient was vaccinated with an adult dose of RECOMBIVAX HB lot # J008227, expiry date 07-FEB-2016 (strength and route of administration were unknown), rather that the pediatric dose for which she was indicated. Thimerosal content was unknown. There were no concomitant medications reported. The patient experienced no adverse effects at this time. There was no product quality complaint involved. The outcome and causality for the event had indeterminate antibodies for Hepatitis B was unknown. Additional information has been requested.
Age: 25.0
Sex: F
Vaccine: HPV4
Symptoms: Serum sickness, Urticaria
Clinical narrative: Pt. saw allergist re: hives and was instructed at that time she had serum sickness that seemed to be caused from sec dose of GARDASIL inj.
Sex: U
Vaccine: HEPA
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report as received from an Medical Assistant refers to an unspecified number of patients of unknown age and gender. On an unknown dates the unspecified number of unspecified patients were vaccinated with unspecified doses of improperly stored VAQTA (lot number not provided) injection (strength, dose, frequency and route not provided). No adverse effect was reported. The outcome of the event was not reported. This is one of 4 reports from the same source. Additional information has been requested.
Age: 18.0
Sex: F
Vaccine: MNQ
Symptoms: Injected limb mobility decreased, Injection site pain
Clinical narrative: (L) lateral deltoid injection site pain unable to move elbow and (L) wrist. The pain and ROM and strength; slowly improving. TX: hot pack and ibuprofen.
Sex: U
Vaccine: HEPA
Symptoms: Inappropriate schedule of drug administration
Clinical narrative: This spontaneous report as received from a pharmacist refers to a patient of unknown demographics. No concurrent conditions or medical history were provided. Physician reproted the patient was administered a dose of VAQTA strength: 25/0.5 (units not provided) injection (dose, route of administration, indication, lot# and expiry date unspecified) outside of the prescribing information schedule: patient received the first dose of vaccine on an unspecified date in 1997 and a booster, second dose of VAQTA on an unspecified date in 2007. No concomitant medications were reported. Additional information is not expected as the reporting physician did not grant permission to contact him.
Sex: U
Vaccine: PPV
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report as received from a nurse via vendor refers to a 2 patients of unknown age and gender. On 04-DEC-2014 the patient was vaccinated with improperly stored PNEUMOVAX 23 (dose and route of administration were not provided). PNEUMOVAX 23 was found to be supported with in-house stability data. No adverse symptoms. Additional information has been requested.
Age: 15.0
Sex: F
Vaccine: VARCEL
Symptoms: Dry skin, Skin exfoliation
Clinical narrative: 11-24-2014 - 12:25 PM - client in clinic with her mother. Client hands and trunk of body shedding skin, very dry and skin from hands peeling off. Mom reports noticing the problem on 11-23-14. I visualized flaking of skin on palms and trunk area. No rash present.
Sex: U
Vaccine: PPV
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report as received from a nurse refers to unspecified number of patients of unknown age and gender. Pertinent medical history was unknown. On an unknown date an unspecified number of patients were vaccinated with PNEUMOVAX 23 (route of administration, dose and anatomical location was unknown) that underwent another temperature excursion. Concomitant medications were unspecified by reporter. No adverse effects reported. The outcome of the events was unknown. No further information was provided. This is one of several reports received from the same reporter. Additional information has been requested.
Age: 4.0
Sex: M
Vaccine: MMR
Symptoms: Cough, Inappropriate schedule of drug administration, Pneumonia bacterial
Clinical narrative: This spontaneous report was received from a other health professional (nurse) refers to a 7 year old male patient. Patient's current condition was reported as pneumonia and no drug allergies were reported. On 28-JAN-2009, the patient was initially vaccinated with M-M-R II dose 1 (lot # and expiry date unspecified) subcutaneous. On 02-DEC-2011 the patient was vaccinated with M-M-R II dose 2, .5 ml, (lot # J0005846, expiry date: not specified). Other suspect therapies included influenza virus vaccine (manufacturer unknown). Concomitant therapies included albuterol. On an unknown date, reporting nurse stated that she was notified by an unspecified nurse that patient was administered two vaccines too close together and the school was considering the vaccines invalid. On an unknown date, reporting nurse stated that patient had no adverse effects to report as a result of receipt of the two vaccines. On an unknown date, after she read patient's chart, she reported that patient had developed bacterial pneumonia, diagnosed on 10-DEC-2011. Patient had been experiencing cough for unspecified amount of time prior to diagnosis. On an unknown date, patient was treated with amoxicillin and was started on FLOVENT HFA 44, twice a day. Outcome of the events were not reported. No product quality complaint (PQC) was reported. On an unknown day, reporting nurse stated she does not believe these events to be connected. Additional information has been requested.
Age: 53.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site rash
Clinical narrative: Rash at injection site resolved 11/27/14.
Age: 63.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site erythema, Injection site swelling
Clinical narrative: Patient has large red bump on injection site. Swollen.
Age: 53.0
Sex: F
Vaccine: TYP
Symptoms: Diarrhoea, Haematochezia, Mucous stools, Muscle spasms, Proctoscopy normal
Clinical narrative: This case was found during archiving activities and has not previously been entered into the global safety database. The case was processed using procedural documents and current labelling documents. This spontaneous report was received from a physician, via a company representative, and via a regulatory authority (FDA - 1-0042), concerns a 53 year old female; local case ID US-9209. The subject's weight was not reported. The subject had no medical history. The subject had a drug history of Premarin and Provera. Concomitant medications included yellow fever vaccine and meningitis vaccination. The subject received typhoid vaccine oral ty21a (capsule, hard, oral, batch 120602A), initiated on 10-DEC-1991 for prophylactic vaccination.  On 13-DEC-1991, 3 days after starting typhoid vaccine oral ty21a, the subject experienced diarrhea and blood in stool, which was diagnosed as rectobleeding by the physician, described as mucus and blood when wiped, after the second capsule and continued through the third. The patient also experienced some cramps on the same date. A proctoscopy was performed, in which nothing was found. Treatment with the typhoid vaccine oral ty21a was withdrawn after the subject was told by the physician to discontinue and not take the fourth capsule. The subject recovered from the diarrhea, rectal bleeding, mucus in stool and cramps on an unknown date. This report was not serious. Revision to the information received on 16-DEC-1991. Upon review the following corrections were made: The event of "rectal bleeding" was considered serious, medically significant (previously considered non-serious).
Age: 53.0
Sex: F
Vaccine: TYP
Symptoms: Rectal haemorrhage
Clinical narrative: This case was found during archiving activities and has not previously been entered into the global safety database. The case was processed using procedural documents and current labelling documents. This spontaneous report was received from a physician, via a company representative, and via a regulatory authority (FDA - 1-0042), concerns a 53 year old female; local case ID US-9209. The subject's weight was not reported. The subject had no medical history. The subject had a drug history of Premarin and Provera. Concomitant medications included yellow fever vaccine and meningitis vaccination. The subject received typhoid vaccine oral ty21a (capsule, hard, oral, batch 120602A), initiated on 10-DEC-1991 for prophylactic vaccination.  On 13-DEC-1991, 3 days after starting typhoid vaccine oral ty21a, the subject experienced diarrhea and blood in stool, which was diagnosed as rectobleeding by the physician, described as mucus and blood when wiped, after the second capsule and continued through the third. The patient also experienced some cramps on the same date. A proctoscopy was performed, in which nothing was found. Treatment with the typhoid vaccine oral ty21a was withdrawn after the subject was told by the physician to discontinue and not take the fourth capsule. The subject recovered from the diarrhea, rectal bleeding, mucus in stool and cramps on an unknown date. This report was not serious. Revision to the information received on 16-DEC-1991. Upon review the following corrections were made: The event of "rectal bleeding" was considered serious, medically significant (previously considered non-serious).
Age: 63.0
Sex: M
Vaccine: FLU3, FLU3, FLU3
Symptoms: Dysphagia, Headache, Pyrexia
Clinical narrative: Case number PHHY2014US153364 is an initial spontaneous report received from a health care professional via the Vaccine Adverse Event Reporting System (VAERS ID: 540805) on 13 Nov 2014, with the follow-up information received from Quality Assurance Department on 02 Dec 2014. This report refers to a 63 year old male patient. His past medical history included allergies penicillin, Amox, Z-PAK, statins, NAPSYN, FELDENE, latex and clams. His concomitant medications included COREG, ASA, Niacin, LOVAZA, metformin, calcium/vitamin D, ZOLOFT, ZETIA and NEXIUM. His past vaccination history included hepatitis B vaccine (manufacturer and batch number: not reported). On 18 Aug 2014, he was vaccinated with FLUVIRIN (batch number: unknown) intramuscularly into his right arm. On 19 Aug 2014, he had a fever, headache and difficulty swallowing. The outcome of the events was condition improving. The events were reported as non serious but the event, difficulty swallowing was upgraded based on the information available in the source documents. The causality of the events was not reported. Upon the follow-up from QA department, it was stated that, the reported FLUVIRIN batch number: 66521011710 is not a valid batch number; hence QA investigation would not be performed. Follow-up information received from Quality Assurance Department on 02 Dec 2014: Updated QA comments about the FLUVIRIN batch number and QA investigation would not be performed.
Age: 63.0
Sex: M
Vaccine: FLU3, FLU3, FLU3
Symptoms: Pharyngeal oedema, Pyrexia
Clinical narrative: Case number PHHY2014US153364 is an initial spontaneous report received from a health care professional via the Vaccine Adverse Event Reporting System (VAERS ID: 540805) on 13 Nov 2014, with the follow-up information received from Quality Assurance Department on 02 Dec 2014. This report refers to a 63 year old male patient. His past medical history included allergies penicillin, Amox, Z-PAK, statins, NAPSYN, FELDENE, latex and clams. His concomitant medications included COREG, ASA, Niacin, LOVAZA, metformin, calcium/vitamin D, ZOLOFT, ZETIA and NEXIUM. His past vaccination history included hepatitis B vaccine (manufacturer and batch number: not reported). On 18 Aug 2014, he was vaccinated with FLUVIRIN (batch number: unknown) intramuscularly into his right arm. On 19 Aug 2014, he had a fever, headache and difficulty swallowing. The outcome of the events was condition improving. The events were reported as non serious but the event, difficulty swallowing was upgraded based on the information available in the source documents. The causality of the events was not reported. Upon the follow-up from QA department, it was stated that, the reported FLUVIRIN batch number: 66521011710 is not a valid batch number; hence QA investigation would not be performed. Follow-up information received from Quality Assurance Department on 02 Dec 2014: Updated QA comments about the FLUVIRIN batch number and QA investigation would not be performed.
Age: 65.0
Sex: F
Vaccine: FLUC3, FLU3
Symptoms: Back pain, Blister, Chest pain, Herpes zoster, Injection site pain
Clinical narrative: Case number PHHY2014US154710 is an initial spontaneous report received from a health care professional via the Vaccine Adverse Events Reporting System (VAERS ID: 543642) on 13 Nov 2014, with the follow-up information received from the Quality Assurance Department (reference number: 340188) on 01 Dec 2014. This report refers to a 65 year old female patient. Her current conditions included end stage renal disease for which she was being given dialysis. Her concomitant medications included LIPITOR, SENSIPAR, calcium acetate, Aspirin, COLACE, VOL-CARE and allopurinol. On 03 Sep 2014, she was vaccinated with FLUVIRIN (batch number: 1411201) intramuscularly into her right arm. On 05 Sep 2014, she had a sharp pain in her right chest radiating to her right shoulder and right armpit. On 12 Sep 2014, she noticed red, blistering, painful rash on right chest and right armpit. On 13 Sep 2014, she went to medical center for treatment and was diagnosed with Shingles. She was given a prescription for severe pain and anti-viral medication. The outcome of the events was not reported. The events were reported as non serious but the events shingles was upgraded based on the NVS-IME list and the events red blistering painful rash and sharp pain in right chest radiating to right shoulder and right upper back were upgraded based on the information available in the source documents. The causality of the events was not reported. Follow-up information received from the Quality Assurance Department (reference number: 340188) on 01 Dec 2014: Product recoded from FLUCELVAX to FLUVIRIN and updated QA reference number.
Age: 65.0
Sex: F
Vaccine: FLUC3, FLU3
Symptoms: Pain, Rash, Rash erythematous
Clinical narrative: Case number PHHY2014US154710 is an initial spontaneous report received from a health care professional via the Vaccine Adverse Events Reporting System (VAERS ID: 543642) on 13 Nov 2014, with the follow-up information received from the Quality Assurance Department (reference number: 340188) on 01 Dec 2014. This report refers to a 65 year old female patient. Her current conditions included end stage renal disease for which she was being given dialysis. Her concomitant medications included LIPITOR, SENSIPAR, calcium acetate, Aspirin, COLACE, VOL-CARE and allopurinol. On 03 Sep 2014, she was vaccinated with FLUVIRIN (batch number: 1411201) intramuscularly into her right arm. On 05 Sep 2014, she had a sharp pain in her right chest radiating to her right shoulder and right armpit. On 12 Sep 2014, she noticed red, blistering, painful rash on right chest and right armpit. On 13 Sep 2014, she went to medical center for treatment and was diagnosed with Shingles. She was given a prescription for severe pain and anti-viral medication. The outcome of the events was not reported. The events were reported as non serious but the events shingles was upgraded based on the NVS-IME list and the events red blistering painful rash and sharp pain in right chest radiating to right shoulder and right upper back were upgraded based on the information available in the source documents. The causality of the events was not reported. Follow-up information received from the Quality Assurance Department (reference number: 340188) on 01 Dec 2014: Product recoded from FLUCELVAX to FLUVIRIN and updated QA reference number.
Age: 65.0
Sex: F
Vaccine: FLUC3, FLU3
Symptoms: Axillary pain, Back pain, Blister, Chest pain, Herpes zoster
Clinical narrative: Case number PHHY2014US154710 is an initial spontaneous report received from a health care professional via the Vaccine Adverse Events Reporting System (VAERS ID: 543642) on 13 Nov 2014, with the follow-up information received from the Quality Assurance Department (reference number: 340188) on 01 Dec 2014. This report refers to a 65 year old female patient. Her current conditions included end stage renal disease for which she was being given dialysis. Her concomitant medications included LIPITOR, SENSIPAR, calcium acetate, Aspirin, COLACE, VOL-CARE and allopurinol. On 03 Sep 2014, she was vaccinated with FLUVIRIN (batch number: 1411201) intramuscularly into her right arm. On 05 Sep 2014, she had a sharp pain in her right chest radiating to her right shoulder and right armpit. On 12 Sep 2014, she noticed red, blistering, painful rash on right chest and right armpit. On 13 Sep 2014, she went to medical center for treatment and was diagnosed with Shingles. She was given a prescription for severe pain and anti-viral medication. The outcome of the events was not reported. The events were reported as non serious but the events shingles was upgraded based on the NVS-IME list and the events red blistering painful rash and sharp pain in right chest radiating to right shoulder and right upper back were upgraded based on the information available in the source documents. The causality of the events was not reported. Follow-up information received from the Quality Assurance Department (reference number: 340188) on 01 Dec 2014: Product recoded from FLUCELVAX to FLUVIRIN and updated QA reference number.
Age: 65.0
Sex: F
Vaccine: FLUC3, FLU3
Symptoms: Musculoskeletal pain, Pain, Rash erythematous, Rash vesicular
Clinical narrative: Case number PHHY2014US154710 is an initial spontaneous report received from a health care professional via the Vaccine Adverse Events Reporting System (VAERS ID: 543642) on 13 Nov 2014, with the follow-up information received from the Quality Assurance Department (reference number: 340188) on 01 Dec 2014. This report refers to a 65 year old female patient. Her current conditions included end stage renal disease for which she was being given dialysis. Her concomitant medications included LIPITOR, SENSIPAR, calcium acetate, Aspirin, COLACE, VOL-CARE and allopurinol. On 03 Sep 2014, she was vaccinated with FLUVIRIN (batch number: 1411201) intramuscularly into her right arm. On 05 Sep 2014, she had a sharp pain in her right chest radiating to her right shoulder and right armpit. On 12 Sep 2014, she noticed red, blistering, painful rash on right chest and right armpit. On 13 Sep 2014, she went to medical center for treatment and was diagnosed with Shingles. She was given a prescription for severe pain and anti-viral medication. The outcome of the events was not reported. The events were reported as non serious but the events shingles was upgraded based on the NVS-IME list and the events red blistering painful rash and sharp pain in right chest radiating to right shoulder and right upper back were upgraded based on the information available in the source documents. The causality of the events was not reported. Follow-up information received from the Quality Assurance Department (reference number: 340188) on 01 Dec 2014: Product recoded from FLUCELVAX to FLUVIRIN and updated QA reference number.
Age: 71.0
Sex: F
Vaccine: FLU3, FLU3
Symptoms: Mobility decreased, Musculoskeletal pain
Clinical narrative: Pain in shoulder, arm, shoulder blade. Weakness in left arm. Seriously diminished range of motion in arm.
Age: 71.0
Sex: F
Vaccine: FLU3, FLU3
Symptoms: Electromyogram, Mobility decreased, Muscular weakness, Musculoskeletal pain, Nuclear magnetic resonance imaging
Clinical narrative: Pain in shoulder, arm, shoulder blade. Weakness in left arm. Seriously diminished range of motion in arm.
Age: 71.0
Sex: F
Vaccine: FLU3, FLU3
Symptoms: Pain in extremity, X-ray
Clinical narrative: Pain in shoulder, arm, shoulder blade. Weakness in left arm. Seriously diminished range of motion in arm.
Age: 60.0
Sex: F
Vaccine: FLU3, FLU3
Symptoms: Adverse event following immunisation
Clinical narrative: Case number PHEH2014US024118, is an initial spontaneous report from a consumer (also patient) received on 01 Dec 2014. This report refers to a 60-year-old female patient. Historical conditions were not reported. No concomitant medication was reported. She was vaccinated with FLUVIRIN (batch number: 1413701) intramuscularly on 08 Oct 2014. On the same day after vaccination in the night patient experienced an allergic reaction that lead her to emergency room two days later. She experienced severe itching over her body and was unable to eat for 5 days due to throat swelling. She broke out with a rash all over her body and throat. Treatment was rendered with BENADRYL. Also it was reported that the patient had to take bath in baking soda and have oatmeal. The patient receives flu vaccine (manufacturer and batch number: not reported) every year and never experienced events. The final outcome of the events was condition unchanged. Seriousness and causality was not reported. Seriousness of the event allergic reaction was upgraded to medically significant based on NVD key events.
Age: 60.0
Sex: F
Vaccine: FLU3, FLU3
Symptoms: Aphagia, Hypersensitivity, Pharyngeal oedema, Pruritus generalised, Rash generalised
Clinical narrative: Case number PHEH2014US024118, is an initial spontaneous report from a consumer (also patient) received on 01 Dec 2014. This report refers to a 60-year-old female patient. Historical conditions were not reported. No concomitant medication was reported. She was vaccinated with FLUVIRIN (batch number: 1413701) intramuscularly on 08 Oct 2014. On the same day after vaccination in the night patient experienced an allergic reaction that lead her to emergency room two days later. She experienced severe itching over her body and was unable to eat for 5 days due to throat swelling. She broke out with a rash all over her body and throat. Treatment was rendered with BENADRYL. Also it was reported that the patient had to take bath in baking soda and have oatmeal. The patient receives flu vaccine (manufacturer and batch number: not reported) every year and never experienced events. The final outcome of the events was condition unchanged. Seriousness and causality was not reported. Seriousness of the event allergic reaction was upgraded to medically significant based on NVD key events.
Age: 18.0
Sex: F
Vaccine: MNQ, TDAP, VARCEL, MNQ, TDAP, VARCEL
Symptoms: Erythema, Peripheral swelling, Skin warm, Tenderness
Clinical narrative: Pt received MENACTRA vaccine on 11-12-14 at 15:45pm. Pt reports noted reaction at site at 12:30pm 11-13-14. Quarter size red raised reaction noted on (R) arm. Warm to touch. Pt denies pain unless area pressed.
Age: 18.0
Sex: F
Vaccine: MNQ, TDAP, VARCEL, MNQ, TDAP, VARCEL
Symptoms: Injection site erythema, Injection site pain, Injection site swelling, Injection site warmth
Clinical narrative: Pt received MENACTRA vaccine on 11-12-14 at 15:45pm. Pt reports noted reaction at site at 12:30pm 11-13-14. Quarter size red raised reaction noted on (R) arm. Warm to touch. Pt denies pain unless area pressed.
Age: 0.49
Sex: U
Vaccine: RV5, HEP
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: Information has been received from a licensed practical nurse concerning a 5 month old patient of unknown gender. On 22-OCT-2014 the patient was vaccinated with RECOMBIVAX HB (lot # J012567, expiration date 30-JAN-2016) (dose and routed not reported). The vaccine was reported to have temperature excursions from 10-SEP-2014 to 12-SEP-2014. No adverse reports. This is one of several reports from the same source. Additional information is not expected because all follow ups requested to complete the case were received.
Age: 32.0
Sex: F
Vaccine: FLU3
Symptoms: Chills, Complication of pregnancy, Exposure during pregnancy, Haemorrhage in pregnancy, Influenza like illness
Clinical narrative: I received the FluZone vaccine at 17 week pregnant. Ten days after getting the shot I developed flu-like symptoms, including fever, chills and body aches that last for three days. Within two days of developing these symptoms, I started to experience pregnancy complications: bleeding and cramping. I visited the ER twice and each time I was assured that the baby was fine. I had two ultrasounds several days apart. Each scan revealed that the baby, placenta and uterus were fine. Within a week of developing these symptoms I went into pre-term labor. My baby was born at 18 weeks gestation without any known cause. I suspect I developed a reaction to the vaccine.
Age: 32.0
Sex: F
Vaccine: FLU3
Symptoms: Pain, Premature delivery, Premature labour, Pyrexia, Ultrasound antenatal screen normal
Clinical narrative: I received the FluZone vaccine at 17 week pregnant. Ten days after getting the shot I developed flu-like symptoms, including fever, chills and body aches that last for three days. Within two days of developing these symptoms, I started to experience pregnancy complications: bleeding and cramping. I visited the ER twice and each time I was assured that the baby was fine. I had two ultrasounds several days apart. Each scan revealed that the baby, placenta and uterus were fine. Within a week of developing these symptoms I went into pre-term labor. My baby was born at 18 weeks gestation without any known cause. I suspect I developed a reaction to the vaccine.
Age: 32.0
Sex: F
Vaccine: FLU3
Symptoms: Uterine spasm
Clinical narrative: I received the FluZone vaccine at 17 week pregnant. Ten days after getting the shot I developed flu-like symptoms, including fever, chills and body aches that last for three days. Within two days of developing these symptoms, I started to experience pregnancy complications: bleeding and cramping. I visited the ER twice and each time I was assured that the baby was fine. I had two ultrasounds several days apart. Each scan revealed that the baby, placenta and uterus were fine. Within a week of developing these symptoms I went into pre-term labor. My baby was born at 18 weeks gestation without any known cause. I suspect I developed a reaction to the vaccine.
Age: 68.0
Sex: F
Vaccine: VARZOS
Symptoms: Blister, Chills, Erythema, Injection site discharge, Injection site pain
Clinical narrative: Red swollen blister - arm swelled drastically- fever chills - itching - oozing blister at sight of injection- pain - given antibiotics.
Age: 68.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site vesicles, Peripheral swelling, Pruritus, Pyrexia
Clinical narrative: Red swollen blister - arm swelled drastically- fever chills - itching - oozing blister at sight of injection- pain - given antibiotics.
Age: 0.56
Sex: F
Vaccine: DTAPHEPBIP, HIBV, PNC13
Symptoms: Body temperature increased, Crying, Rash generalised, Rash macular
Clinical narrative: Crying off and on. Rash on entire body including face. Tem. 101.7.
Age: 3.0
Sex: F
Vaccine: FLU4
Symptoms: Hypotonia, Pallor
Clinical narrative: Mom went to put in car seat and child went limp, brought back inside Health Dept, child pale, awake, feet elevated, B/P 80/58, ambulance called to check out child. Color improved when ambulance arrived. Evaluated child, did not go to hospital, will follow-up with pediatrician today.
Age: 45.0
Sex: F
Vaccine: FLU4
Symptoms: Injected limb mobility decreased, Pain in extremity
Clinical narrative: Person could not lift arm after vaccine and is still experiencing pain 8 weeks later and is going to her HCP to follow up.
Age: 63.0
Sex: F
Vaccine: TYP
Symptoms: Abdominal distension, Abdominal pain, Dizziness, Eye pain, Gastrooesophageal reflux disease
Clinical narrative: Received oral vaccine in our clinic on 11/27/2014. Kept pills refrigerated as per instructions. Did not begin the pills until 12/4/2014 at 7 am. That evening began to develop abdominal cramping and distention with reflux. Also reports headache dizziness, and "prickly eyes". 12/5/2014- Reports small amount of bright red blood in stool. Denied any diarrhea or constipation. Continued gas pains, abdominal distention, dizziness, headache and "prickly eyes". Self treated with an OTC antacid, Gas-X and Visine for eye discomfort. Reports speaking with a "Doctor friend who advised her to stop the pills because they did not agree with her".  12/6/2014 - Reports feeling a little better and took #2 pill. Reports that the symptoms described above became more intense. She again self treated with OTC antacid, Gas X, and Visine. Her symptoms continued and she reports being "very sick". Did not seek emergency or medical care. Reports improvement of symptoms over the next 1-2 days. Did not take pill #3 on 12/8/2014. Reports feeling better; headache, dizziness, abdominal cramping, blood in stool, and prickly eyes have resolved, but still experiencing some abdominal bloating.
Age: 63.0
Sex: F
Vaccine: TYP
Symptoms: Haematochezia, Headache, Malaise
Clinical narrative: Received oral vaccine in our clinic on 11/27/2014. Kept pills refrigerated as per instructions. Did not begin the pills until 12/4/2014 at 7 am. That evening began to develop abdominal cramping and distention with reflux. Also reports headache dizziness, and "prickly eyes". 12/5/2014- Reports small amount of bright red blood in stool. Denied any diarrhea or constipation. Continued gas pains, abdominal distention, dizziness, headache and "prickly eyes". Self treated with an OTC antacid, Gas-X and Visine for eye discomfort. Reports speaking with a "Doctor friend who advised her to stop the pills because they did not agree with her".  12/6/2014 - Reports feeling a little better and took #2 pill. Reports that the symptoms described above became more intense. She again self treated with OTC antacid, Gas X, and Visine. Her symptoms continued and she reports being "very sick". Did not seek emergency or medical care. Reports improvement of symptoms over the next 1-2 days. Did not take pill #3 on 12/8/2014. Reports feeling better; headache, dizziness, abdominal cramping, blood in stool, and prickly eyes have resolved, but still experiencing some abdominal bloating.
Age: 77.0
Sex: F
Vaccine: FLUC3
Symptoms: Death, Diarrhoea
Clinical narrative: Pt. had diarrhea during nap.  Increased Immodium, no other complaints following.  Patient was found deceased 9:30 AM 10/22/2014. Was normal with no problems 5 PM previous evening.
Age: 24.0
Sex: M
Vaccine: FLU3
Symptoms: Abasia, Hypoaesthesia, Lumbar puncture, Nuclear magnetic resonance imaging brain, Pain in extremity
Clinical narrative: Leg pain started 11-22-14; not able to feel feet and legs continued with progression to point of not able to ambulate. Current inpatient.
Age: 27.0
Sex: F
Vaccine: MMR
Symptoms: Exposure during pregnancy
Clinical narrative: Hospital called to say client was 7 weeks pregnant now and when she received MMR vaccine on 11-3-14 she was 4 weeks pregnant and did not know this.
Age: 27.0
Sex: F
Vaccine: RAB
Symptoms: Abdominal pain upper, Headache, Nausea, Palpitations
Clinical narrative: Heart racing, stomach pain, nausea, massive headache.
Age: 69.0
Sex: M
Vaccine: FLUX
Symptoms: Activities of daily living impaired, Inflammation, Musculoskeletal pain, Rotator cuff syndrome, Sleep disorder
Clinical narrative: Pain right shoulder, pain interferes with sleep, normal daily activites.  Dr. (orthopedist diagnosed rotator-cuff tendinopathy, prescribed ongoing physical therapy.
Age: 55.0
Sex: F
Vaccine: FLU3
Symptoms: Injection site pain, Injection site reaction, Myalgia, Pain
Clinical narrative: ACHING/ DULL PAIN, CERTAIN MOTIONS TRIGGER PAIN, MUSCLE PAIN, CLOSE TO INJECTION SPOT. BEEN TAKING IBUPROFEN/TYLENOL. PAIN STARTED NEXT DAY. INJECTION SITE IS LEFT UPPER ARM (DELTOID).
Age: 1.16
Sex: M
Vaccine: DTAPHEPBIP
Symptoms: Injection site erythema, Injection site swelling
Clinical narrative: Day after Pertussis vaccine my sons arm swelled up very much and turned red at injection site.
Age: 47.0
Sex: F
Vaccine: FLU3
Symptoms: Activities of daily living impaired, Arthralgia, Injection site pain, Joint crepitation, Mobility decreased
Clinical narrative: Sharp left shoulder pain aggravated by lifting, movement. Pain with ADL's, decreased mobility, joint pain. joint tenderness, popping.
Age: 47.0
Sex: F
Vaccine: FLU3
Symptoms: Pain
Clinical narrative: Sharp left shoulder pain aggravated by lifting, movement. Pain with ADL's, decreased mobility, joint pain. joint tenderness, popping.
Age: 5.0
Sex: M
Vaccine: FLUN4
Symptoms: Chills, Influenza, Pain, Pyrexia, Vomiting
Clinical narrative: Full blown flu.  Vomiting, 103.5 temperature, chills, body aches.  Administered ibuprofen and acetaminophen.  Fever only controlled with use of both.
Age: 38.0
Sex: F
Vaccine: FLU4
Symptoms: Hypoaesthesia, Injection site erythema, Injection site pain, Injection site swelling, Lymphadenopathy
Clinical narrative: Erythema, swelling and tenderness at site. Temperature of 38 Celsius. Left axillary swelling and tenderness with motion. Numbness and swelling in sternal notch.
Age: 38.0
Sex: F
Vaccine: FLU4
Symptoms: Sternitis, Tenderness
Clinical narrative: Erythema, swelling and tenderness at site. Temperature of 38 Celsius. Left axillary swelling and tenderness with motion. Numbness and swelling in sternal notch.
Age: 1.27
Sex: M
Vaccine: DTAPIPVHIB
Symptoms: Blood culture negative, Febrile convulsion, Nitrite urine present
Clinical narrative: Child had a febriles seizure.
Age: 59.0
Sex: M
Vaccine: FLU4, PPV, TDAP
Symptoms: Cellulitis
Clinical narrative: Cellulitis of left arm following administration of influenza vaccine and Tdap vaccine in left arm on 12/2/14.  Treated with Keflex tid for 10 days on 12/5/14.