chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 83.0
Sex: M
Vaccine: VARZOS
Symptoms: Herpes zoster, Laboratory test abnormal, Malaise, Neuralgia, Ophthalmic herpes zoster
Clinical narrative: Information has been received from a retired pediatric nurse practitioner concerning her 83 year old husband who on 08-MAY-2008 was vaccinated with a dose of ZOSTAVAX (lot#656861/0329U). The patient was seen in the emergency room on 21-JUL-2009 (date reported by reporter) for pain in right eye and over the eye. He was diagnosed with conjunctivitis and probable early shingles. He was given an prescription for the conjunctivitis and another for acyclovir to be filled the next day if it was shingles. The next day it was obvious he had shingles and the prescription was filled and started on 22-JUN-2008 (date reported by reporter). The swelling continued into his right eye and he was seen on 24-JUN-2008 (date reported by reporter) by an ophthalmologist. She did an exam and changed his eye drops and saw him again on 30-JUN-2008 (date reported by reporter). He had another appointment in September. On 15-JUN-2008(date reported by reporter) the patient was seen by the family doctor, because he felt ill. He had blood work on that day which was mostly within normal limits. He had another appointment with him on 05-AUG-2008 (date reported by reporter). The doctor gave him an prescription for LYRICA for nerve pain. It relieved the nerve pain but caused drowsiness and dizziness. At that time, because he was not eating well, the reporter started him on minerals (unspecified) (+) protein (unspecified) (+) vitamins (unspecified) (High Protein Ensure) and he had improved greatly. At the time of the report, the patient's status was unknown. Follow-up information has been received on 28-MAY-2015, from the reporting nurse, who was also the patient's wife. The patient's concurrent conditions included allergy to DAYPRO. It was reported that the patient received a dose of ZOSTAVAX in 2009. His concomitant medication was reported as "dalacyclovir". At the time of the report, the patient was experiencing a second episode of shingles (onset date unknown). He sought unspecified medical attention and was treated with DALTREX, per oral. The outcome of the adverse event was unknown. The relatedness between use of ZOSTAVAX and reported adverse events was not provided. Additional information has been requested.
Age: 83.0
Sex: M
Vaccine: VARZOS
Symptoms: Somnolence
Clinical narrative: Information has been received from a retired pediatric nurse practitioner concerning her 83 year old husband who on 08-MAY-2008 was vaccinated with a dose of ZOSTAVAX (lot#656861/0329U). The patient was seen in the emergency room on 21-JUL-2009 (date reported by reporter) for pain in right eye and over the eye. He was diagnosed with conjunctivitis and probable early shingles. He was given an prescription for the conjunctivitis and another for acyclovir to be filled the next day if it was shingles. The next day it was obvious he had shingles and the prescription was filled and started on 22-JUN-2008 (date reported by reporter). The swelling continued into his right eye and he was seen on 24-JUN-2008 (date reported by reporter) by an ophthalmologist. She did an exam and changed his eye drops and saw him again on 30-JUN-2008 (date reported by reporter). He had another appointment in September. On 15-JUN-2008(date reported by reporter) the patient was seen by the family doctor, because he felt ill. He had blood work on that day which was mostly within normal limits. He had another appointment with him on 05-AUG-2008 (date reported by reporter). The doctor gave him an prescription for LYRICA for nerve pain. It relieved the nerve pain but caused drowsiness and dizziness. At that time, because he was not eating well, the reporter started him on minerals (unspecified) (+) protein (unspecified) (+) vitamins (unspecified) (High Protein Ensure) and he had improved greatly. At the time of the report, the patient's status was unknown. Follow-up information has been received on 28-MAY-2015, from the reporting nurse, who was also the patient's wife. The patient's concurrent conditions included allergy to DAYPRO. It was reported that the patient received a dose of ZOSTAVAX in 2009. His concomitant medication was reported as "dalacyclovir". At the time of the report, the patient was experiencing a second episode of shingles (onset date unknown). He sought unspecified medical attention and was treated with DALTREX, per oral. The outcome of the adverse event was unknown. The relatedness between use of ZOSTAVAX and reported adverse events was not provided. Additional information has been requested.
Age: 15.0
Sex: U
Vaccine: HPV4
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report as received from a nurse refers to a 15 year old patient of unknown gender. Medical history and concurrent conditions were not reported. On 22-APR-2015, the patient was vaccinated with an improperly stored GARDASIL dose 3, lot # K005881, expiration date 14-JAN-2017 (dose and route were not reported). No adverse event reported. No co-suspect and concomitant therapies were reported. This is one of several reports from the same source. Additional information is not expected. All follow up requested to complete the case were received.
Age: 16.0
Sex: U
Vaccine: HPV4
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report as received from a nurse refers to a 16 year old patient of unknown gender. Medical history and concurrent conditions were not reported. On 23-APR-2015, the patient was vaccinated with an improperly stored GARDASIL dose 3, lot # K005881, expiration date 14-JAN-2017 (dose and route were not reported). No adverse event reported. No co-suspect and concomitant therapies were reported. This is one of several reports from the same source. Additional information is not expected. All follow up requested to complete the case were received.
Sex: U
Vaccine: HPV4
Symptoms: Fall, Syncope
Clinical narrative: This spontaneous report was received from a nurse via company representative refers to unknown number of patients of unknown demographics. Patients medical history and concurrent conditions were not reported. On an unknown date, unspecified number of patients were vaccinated with GARDASIL (dose, route of administration, lot# and anatomical location was unknown). Concomitant medications were unspecified by reporter. On an unknown date, 15 min after vaccination, unspecified number of patients fell and fainted. No product quality complaint (PQC) was involved. The outcome of the events was unknown. The causal relationship between the events and GARDASIL vaccine was not reported. Additional information has been requested.
Sex: U
Vaccine: PPV
Symptoms: Expired product administered, Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report was received from a registered nurse and refers to a patient of unknown age. No pertinent medical history, concurrent conditions or concomitant medications were reported. On 22-MAY-2015, the patient was vaccinated with improperly stored PNEUMOVAX23 lot # J011045 with an expiration date of 15-MAY-2015 (expired vaccine administered). The reporter stated that the PNEUMOVAX23 did not have any previous temperature excursions. No adverse symptoms reported. The outcome of the events were unknown. Additional information has been requested.
Age: 8.0
Sex: M
Vaccine: HEP, HEPA, IPV, MMRV, PNC13, TDAP
Symptoms: Rash
Clinical narrative: Rash.
Sex: U
Vaccine: HPV4
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report as received from the nurse refers to unspecified number of patients. No medical history and concurrent conditions were reported. On an unknown date, the unspecified number of patients were inadvertently vaccinated with improperly stored GARDASIL (confirmed not GARDASIL 9) (lot number, dose, frequency and route of administration was not reported) injection and did not experience any adverse event. The outcome of the reported events were unknown. The reporter considered incorrect product storage to be not related to GARDASIL. No product quality complaint (PQC) was filed. No further information was provided. This is one of the 4 reports of the same reporter. Additional information has been requested.
Sex: U
Vaccine: HPV4
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report was received from a medical assistant refers to an unspecified number of patients of unknown age and gender. The patient's pertinent medical history and concurrent conditions were not provided. On unknown dates, the patients were vaccinated with GARDASIL (dose numbers, route, lot numbers and expiration date were not provided). Concomitant therapy information was not provided. On unknown dates, the patients experienced incorrect product storage as GARDASIL was improperly stored and unspecified doses were administered. No adverse effects were reported. It was unknown if the patients sought medical attention. At the time of the report, the patients' status was unknown. Additional information has been requested. This is one of several reports received from the same source.
Age: 0.17
Sex: M
Vaccine: DTAPIPVHIB, PNC13
Symptoms: Crying, Hypotonia, Infantile spitting up, Neurological examination
Clinical narrative: 6/1/15 Mom returned to office approximately ten minutes after she had left with infant. She stated that patient cried after receiving shots. He quieted in the elevator on the way to the car. In her car she lay him down to feed him and noted him to be limp and lacking muscle tone. He was still breathing and had no color change. He had no abnormal motor activity. She rushed back to the office. Our office manager noted him to be somewhat limp when appeared with him. She pulled from a patient room to examine patient. When I arrived, patient was breathing quietly. He had normal capillary refill. Oxygen saturations were obtained and were 97% RA. His heart rate was 96 and his respirations were 32. Patient awoke while and became very active while we obtained O2 Sats so we were unable to obtain a manual blood pressure. I requested mom feed patient in the office and she did so without incident. I also requested she watch him today and tomorrow at home and gave her a work note to do so. I will recheck him tomorrow and perform a neurological exam again tomorrow. I will also report this incident to the VAERS. Etiology of event not completely certain although I suspect vasovagal episode. Patient with no pause in respiration, no swelling, and no evidence of respiratory difficulty to suggest anaphylaxis. His mother did breast feed him just prior to immunizations and she did say that he spits up frequently. He many also have refluxed and choked on reflux although lack of color change makes this less likely. 6/2/215 Return visit At follow up visits his mother states that he appeared back to baseline. He was reportedly playful and interactive. His appetite was decreased the day the immunizations were given but resumed the next day. He had no fevers, no fussiness, and no irritability. On my exam, patient's neurological status was completely normal and consisten with his exam prior to his immunizations. I discussed the episode at length with his mother. His maternal grandmother reportedly told his mother that one of her sibs had had a similar incident with immunizations when she was an infant. Patient also has a sib who had breath holdin spells as an infant. Incidnet is most consistent with a vasovagal response. I suggested we give further immunizations individually and patient's mother is in agreement.
Age: 18.0
Sex: U
Vaccine: HPV4
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report as received from a nurse refers to a 18 year old patient of unknown gender. Medical history and concurrent conditions were not reported. On 18-MAY-2015, the patient was vaccinated with an improperly stored GARDASIL dose 3, lot # K0055881, expiration date 14-JAN-2017 (dose and route were not reported). No adverse event reported. No co-suspect and concomitant therapies were reported. This is one of several reports from the same source. Additional information is not expected. All follow up requested to complete the case were received.
Sex: U
Vaccine: RV5
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report was received from a medical assistant refers to an unspecified number of patients of unknown age and gender. The patient's pertinent medical history and concurrent conditions were not provided. On unknown dates, the patients were vaccinated with, oral, ROTATEQ (dose numbers, route, lot numbers and expiration date were not provided). Concomitant therapy information was not provided. On unknown dates, the patients experienced incorrect product storage as, oral, ROTATEQ was improperly stored and unspecified doses were administered. No adverse effects were reported. It was unknown if the patients sought medical attention. At the time of the report, the patient's status was unknown. This is one of several reports received from the same source. Additional information has been requested.
Age: 14.0
Sex: F
Vaccine: MMR
Symptoms: Feeling cold, Hypoaesthesia
Clinical narrative: My daughter complained of being unusually cold, and having numbness in her hand.
Age: 4.0
Sex: F
Vaccine: DTAPIPV, MMR, VARCEL
Symptoms: Injection site cellulitis, Injection site erythema, Injection site induration, Injection site pain, Injection site warmth
Clinical narrative: AREA INJECTED BECAME PAINFUL, HARD, RED AND HOT TO THE TOUCH.
Age: 1.24
Sex: F
Vaccine: MMRV, VARCEL
Symptoms: Extra dose administered, No adverse event
Clinical narrative: This spontaneous report as received from a nurse practitioner refers to a 14 month old female patient. Concurrent or medical conditions were not reported. On 20-MAY-2015, the patient was inadvertently vaccinated with (Merck) VARIVAX (dose, route and lot number were not reported) and with (Merck) PROQUAD (dose, route and lot number were not reported) at the same office visit. No adverse effect reported. Additional information has been requested.
Sex: U
Vaccine: VARCEL
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report as received from a licensed practical nurse refers to an unspecified number of patients of unknown age and gender. Pertinent medical history, concurrent conditions, drug reactions or allergies were not reported. On unspecified dates the patients were vaccinated with improperly stored VARIVAX (Merck) lot # K005428, expiration date 15-APR-2016 and lot # L001335, expiration date 13-JAN-2017, 0.5 ml, once, subcutaneous (anatomical location was not reported). No concomitant therapies were reported. No adverse events were reported. Additional information has been requested.
Age: 69.0
Sex: M
Vaccine: PNC13
Symptoms: Dizziness, Tremor
Clinical narrative: Approx at 5 pm on 5-19-15 patient started experiencing dizziness and shaking. Required visit to urgent care. Was treated w/ BENADRYL and sent home. Patient reports experiencing symptoms for 2 days.
Age: 1.01
Sex: U
Vaccine: HEPA, HIBV, MMR, VARCEL
Symptoms: Rash erythematous
Clinical narrative: 5/9/2015 developed small red bumps on chest that continued to increase and spread outward for 3 days and then faded away. No fever-eating drinking well.
Age: 18.0
Sex: U
Vaccine: HPV4
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report as received from a nurse refers to a 18 year old patient of unknown gender. Medical history and concurrent conditions were not reported. On 04-MAY-2015, the patient was vaccinated with an improperly stored GARDASIL dose 3, lot # K005881, expiration date 14-JAN-2017 (dose and route were not reported). No adverse event reported. No co-suspect and concomitant therapies were reported. This is one of several reports from the same source. Additional information is not expected. All follow up requested to complete the case were received.
Sex: U
Vaccine: PPV
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report as received from the nurse refers to unspecified number of patients. No medical history and concurrent conditions were reported. On an unknown date, the unspecified number of patients were inadvertently vaccinated with improperly stored PNEUMOVAX23 (lot number, dose, frequency and route of administration were not reported) and did not experience any adverse event. The outcome of the reported events were unknown. The reporter considered incorrect product storage to be not related to PNEUMOVAX23. No product quality complaint (PQC) was filed. No further information was provided. This is one of the 4 reports of the same reporter. Additional information has been requested.
Age: 17.0
Sex: U
Vaccine: HPV4
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report as received from a nurse refers to a 17 year old patient of unknown gender. Medical history and concurrent condition were not reported. On 11-FEB-2015, the patient was vaccinated with an improperly stored GARDASIL dose 3, lot # K005881, expiration date 14-JAN-2017 (dose and route were not reported). No adverse event reported. No co-suspect and concomitant therapies were reported. This is one of several reports from the same source. Additional information is not expected. All follow up requested to complete the case were received.
Age: 13.0
Sex: F
Vaccine: HPV4, MNQ
Symptoms: Blister, Erythema, Injection site erythema, Injection site swelling, Pruritus
Clinical narrative: Began 2 days after injection with redness, swelling, tightness of the right arm and grouped vesicles on erythematous base covering extremities and think -very pruritic with dermatographism.
Age: 13.0
Sex: F
Vaccine: HPV4, MNQ
Symptoms: Skin tightness
Clinical narrative: Began 2 days after injection with redness, swelling, tightness of the right arm and grouped vesicles on erythematous base covering extremities and think -very pruritic with dermatographism.
Age: 1.59
Sex: F
Vaccine: HEPA
Symptoms: Pyrexia
Clinical narrative: Pt presented back to clinic with a low grade fever of 101.0.
Age: 48.0
Sex: F
Vaccine: HEPAB, PPV, TYP, YF
Symptoms: Abdominal pain, Erythema, Injection site erythema, Injection site pain, Pain
Clinical narrative: Patient reported that two days after injection she experienced intense pain and redness in her upper left arm. It went from her elbow up to her arm pit and into chest area. She took some Benadryl and slept, and says that symptoms resolved within two days. She also reports having body aches during that time. She did not seek any medical care and did not report symptoms until next visit in April.
Age: 53.0
Sex: M
Vaccine: TDAP
Symptoms: Computerised tomogram head, Loss of consciousness, Seizure
Clinical narrative: Seizure with LOC on 05/31/2015.
Age: 11.0
Sex: M
Vaccine: HPV4, MNQ, TDAP
Symptoms: Asthenia, Hypersensitivity, Pyrexia, Rash
Clinical narrative: A small rash was noticed on the stomach and Aveno lotion was applied to soothe. The rash slowly progressed to cover the all body parts excluding the face and head. Benadryl was given and hydrocortisone was applied. He was taken to Dr. on 5/30/15 at 11:30 AM. She looked at the rash and said it was viral and prescribed Predinisone 20 mg for 5 days. On Monday the rash had increased and he had a low fever and felt weak. He was taken to another Dr. She looked at his rash and checked his ears and throat. She believed it was most likely an allergic reaction but did not rule out the possibility of it being viral. She gave him a Depomedrol 60mg IM and prescribed Prednisone 40 mg for 2 days, 35 mg for 2 days, and has him tapering down by 5 mg until he reaches 10mg for 2 days. As of today his rash is still present and he had a fever of 100 F.
Age: 0.2
Sex: U
Vaccine: RV1
Symptoms: Blood test normal, Haematochezia, Intussusception, Vomiting projectile, X-ray gastrointestinal tract abnormal
Clinical narrative: This case was reported by a nurse via call center representative and described the occurrence of intussusception in a 2-month-old unk patient who received ROTARIX. On 4th May 2015, the patient received ROTARIX. On an unknown date, less than a month after receiving ROTARIX, the patient experienced intussusception (serious criteria hospitalization and GSK medically significant), blood in stool (serious criteria hospitalization and GSK medically significant) and vomiting projectile (serious criteria hospitalization). On an unknown date, the outcome of the intussusception, blood in stool and vomiting projectile were unknown. It was unknown if the reporter considered the intussusception, blood in stool and vomiting projectile to be related to ROTARIX. Additional details provided as follows: The reporting nurse stated that she has completed and filed VAERS form already, and would fax the report to GSK product safety. The patient did not required surgery. The nurse did not have a VAERS case number at time of report.
Age: 60.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site erythema, Injection site infection, Injection site swelling, Injection site warmth
Clinical narrative: Admin. at roughly 3:37 pm 6/1/15 (June 1st). Patient presented w/swelling at injec site (relatively large) pinkish and warmth to touch (on 6/3/15). Patient went to MD and was prescribed cephalexin 500,g 1 cap Q8H for 7 days. MD believes it's due to infection at site.
Age: 0.25
Sex: F
Vaccine: HIBV, PNC13
Symptoms: Injection site erythema, Injection site swelling
Clinical narrative: Redness and raised area to thigh by site of injection.
Age: 65.0
Sex: F
Vaccine: PNC13
Symptoms: Neck pain, Pain
Clinical narrative: Body aches and neck pain, 6 hours after vaccine administration. Patient took acetaminophen with minimal relief.
Sex: U
Vaccine: RV5
Symptoms: Intussusception, Malaise
Clinical narrative: This spontaneous report as received from a consumer refers to patient of unknown age and gender with no pertinent medical history/drug allergies or drug reactions reported. On an unknown date, the patient was vaccinated with a dose of oral, ROTATEQ, (route, anatomical location, lot# and expiration date were not reported). There was not concomitant therapy reported. On an unknown date, the patient experienced intussusception and malaise reported as "close relative got intussusception and was very ill". The outcome of malaise and intussusception was unknown. This is a linked case with 1506USA000495 (original case) from the same reporter. Additional information has been requested.
Sex: U
Vaccine: HPV4
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report has been received from a Registered Nurse concerning an unknown number of patients of unspecified age and gender. Concurrent conditions and pertinent medical history of the patients were not reported. On an unknown date, the patients were vaccinated with GARDASIL, intramuscular injection, (strength not provided), 0.5 ml, once, (dose in series unspecified), that were improperly stored. The reporting nurse stated that she did not have patient details including dates of administration. Additionally, the lot numbers and expiration dates of GARDASIL were provided: (Lot # K008213, expiration date on 17-DEC-2016), (Lot # K009482, expiration date on 06-MAR-2017), (Lot # K007828, expiration date on 02-MAR-2017). There was not adverse effects reported. Additional information has been requested.
Age: 45.0
Sex: F
Vaccine: HPV2
Symptoms: Drug administered to patient of inappropriate age, Human papilloma virus test positive
Clinical narrative: This case was reported by a consumer and described the occurrence of human papilloma virus test positive in a 49-year-old female patient who received CERVARIX. On an unknown date, the patient received CERVARIX at an unknown dose. On an unknown date, unknown after receiving CERVARIX, the patient experienced human papilloma virus test positive and inappropriate age at vaccine administration. On an unknown date, the outcome of the human papilloma virus test positive and inappropriate age at vaccine administration were unknown. It was unknown if the reporter considered the human papilloma virus test positive to be related to CERVARIX. Additional information received: Patient stated when she was 44, she fought her insurance company to receive CERVARIX. After a year, they agrees to pay for it, so she went and got the vaccine, and administered it to herself (at age 45) following the dosing schedule in the Pl. She had a recent test that said she was potentially HPV positive. She feels that is impossible because she has had two sex partners in the last 4 years. She did not wish to answer template questions, because she feels it is not "yet" and adverse event. Permission to contact being denied.
Sex: U
Vaccine: MMRV
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: Information has been received from a nurse referring to a patient of unknown age and gender. No relevant medical history or concurrent conditions were reported. On 01-JUN-2015 the patient was vaccinated with one dose of improperly stored PROQUAD (lot # L002420, expiration date 23-JUL-2016; strength and route not reported). No adverse effects were reported. Additional information has been requested.
Age: 36.0
Sex: F
Vaccine: FLU3
Symptoms: Abortion spontaneous, Exposure during pregnancy
Clinical narrative: Case number PHHY2014US013364 is an initial spontaneous report received from the Vaccine Adverse Event Reporting System (VAERS reference number: 516157) website on 03 Feb 2014 and with a follow-up information received from the Quality Assurance Department (reference number: 1000069) on 12 May 2015 with the follow-up information received from Quality Assurance Department (reference number: 1000069) on 26 May 2015. This case refers to a 36-year-old pregnant female patient. Her past medical history was not reported. Her concomitant medications included prenatal vitamins, fish oil and levothyroxine. On 24 Nov 2013, she was vaccinated with FLUVIRIN (batch number: 66521011602) intramuscularly into the left arm. On 08 Dec 2013, she had a miscarriage. The outcome of the events was not reported. The causality and seriousness of the events were not reported. The Quality Assurance department confirmed that the reported batch number doesn't belong to FLUVIRIN. Based on the investigation performed, the QA department stated that, FLUVIRIN (batch number: unknown) was manufactured in accordance with the approved internal procedures and it was in compliance with the cGMP requirements. Non-significant follow-up information received from the Quality Assurance Department (reference number: 1000069) on 12 May 2015: Updated QA reference number only. Follow-up information received from the Quality Assurance Department (reference number: 1000069) on 26 May 2015: Updated FLUVIRIN batch review report.
Age: 55.0
Sex: F
Vaccine: FLU3, FLU3
Symptoms: Asthenia, Blood test normal, Chest X-ray normal, Cough, Dizziness
Clinical narrative: Case number PHHY2015US060030, is an initial spontaneous report received from the Vaccine Adverse Event Reporting System (VAERS, reference number: 563074) website on 12 May 2015 with a follow up report from QA department received on 26 May 2015. This report refers to a 55 year old female patient. Medical history was none. Concomitant medications included ZOLOFT at a dose of 100 mg daily and NORCO at a dose of "5-325" twice a day. She was vaccinated with FLUVIRIN (batch number: unknown) intramuscularly in left arm on 27 Jan 2015. On the same day after vaccination, she developed shakiness, nausea, dizziness, vomiting, extreme body aches, headache, cough and low grade fever. On 28 Jan 2015, she presented with high fever at a body temperature of 102.7 degree Fahrenheit. She went to hospital approximately around 4:00 PM, and was given intravenous drip and medication for fever. In the hospital, blood tests, chest x-ray, urine test and flu swab test showed negative results. Fever finally came down at approximately 8:30 PM. She was released from the hospital . On 29 Jan 2015, she still had body aches, weakness, nausea and headache. Final outcome of the events was complete recovery. Events were reported as non-serious. Seriousness assessment of the events was upgraded to serious (medically significant) based on the information available in the source document. Causality was not reported. The QA department reported that "as we do not have a valid batch number available for this case and it is a standard request, it will not be investigated". Follow up report from QA department received on 26 May 2015: Updated QA department's comments.
Age: 55.0
Sex: F
Vaccine: FLU3, FLU3
Symptoms: Headache, Influenza virus test negative, Nausea, Pain, Pyrexia
Clinical narrative: Case number PHHY2015US060030, is an initial spontaneous report received from the Vaccine Adverse Event Reporting System (VAERS, reference number: 563074) website on 12 May 2015 with a follow up report from QA department received on 26 May 2015. This report refers to a 55 year old female patient. Medical history was none. Concomitant medications included ZOLOFT at a dose of 100 mg daily and NORCO at a dose of "5-325" twice a day. She was vaccinated with FLUVIRIN (batch number: unknown) intramuscularly in left arm on 27 Jan 2015. On the same day after vaccination, she developed shakiness, nausea, dizziness, vomiting, extreme body aches, headache, cough and low grade fever. On 28 Jan 2015, she presented with high fever at a body temperature of 102.7 degree Fahrenheit. She went to hospital approximately around 4:00 PM, and was given intravenous drip and medication for fever. In the hospital, blood tests, chest x-ray, urine test and flu swab test showed negative results. Fever finally came down at approximately 8:30 PM. She was released from the hospital . On 29 Jan 2015, she still had body aches, weakness, nausea and headache. Final outcome of the events was complete recovery. Events were reported as non-serious. Seriousness assessment of the events was upgraded to serious (medically significant) based on the information available in the source document. Causality was not reported. The QA department reported that "as we do not have a valid batch number available for this case and it is a standard request, it will not be investigated". Follow up report from QA department received on 26 May 2015: Updated QA department's comments.
Age: 55.0
Sex: F
Vaccine: FLU3, FLU3
Symptoms: Tremor, Urine analysis normal, Vomiting
Clinical narrative: Case number PHHY2015US060030, is an initial spontaneous report received from the Vaccine Adverse Event Reporting System (VAERS, reference number: 563074) website on 12 May 2015 with a follow up report from QA department received on 26 May 2015. This report refers to a 55 year old female patient. Medical history was none. Concomitant medications included ZOLOFT at a dose of 100 mg daily and NORCO at a dose of "5-325" twice a day. She was vaccinated with FLUVIRIN (batch number: unknown) intramuscularly in left arm on 27 Jan 2015. On the same day after vaccination, she developed shakiness, nausea, dizziness, vomiting, extreme body aches, headache, cough and low grade fever. On 28 Jan 2015, she presented with high fever at a body temperature of 102.7 degree Fahrenheit. She went to hospital approximately around 4:00 PM, and was given intravenous drip and medication for fever. In the hospital, blood tests, chest x-ray, urine test and flu swab test showed negative results. Fever finally came down at approximately 8:30 PM. She was released from the hospital . On 29 Jan 2015, she still had body aches, weakness, nausea and headache. Final outcome of the events was complete recovery. Events were reported as non-serious. Seriousness assessment of the events was upgraded to serious (medically significant) based on the information available in the source document. Causality was not reported. The QA department reported that "as we do not have a valid batch number available for this case and it is a standard request, it will not be investigated". Follow up report from QA department received on 26 May 2015: Updated QA department's comments.
Age: 60.0
Sex: M
Vaccine: FLU3, FLU3
Symptoms: Death, Unresponsive to stimuli
Clinical narrative: Case number PHHY2015US059065, is an initial spontaneous report received from Vaccine Adverse Event Reporting System (VAERS reference number: 564361) website on 12 May 2015, with the follow-up information received from the Quality Assurance Department (reference number: 1000209) on 15 May 2015 with the follow-up information received from Quality Assurance Department (reference number: 1000209) on 29 May 2015. This report refers to a 60-year-old male patient. Past medical history included cerebral palsy, chronic obstructive pulmonary disease, dysphagia and intellectual disabilities. Current illnesses were none. Concomitant medications included omeprazole, lactulose, ZANAFLEX, SENEKOT, FENTANYL, LEXAPRO, bisacodyl and NUTREN. The patient was vaccinated with FLUVIRIN (batch number: not reported) into the left arm on 01 Oct 2014 at 06:00 PM. On 03 Oct 2014 at 04:15 AM, the patient was found unresponsive. At 04:39 AM, the patient was pronounced dead. Causality was not reported. Based on the investigation performed, the QA department stated that, FLUVIRIN (batch number: unknown) was manufactured in accordance with the approved internal procedures and it was in compliance with the cGMP requirements. Non-significant follow-up information received from the Quality Assurance Department (reference number: 1000209) on 15 May 2015: Updated QA reference number only. Non-significant follow-up information received from the Quality Assurance Department (reference number: 1000209) on 29 May 2015: Updated FLUVIRIN batch review report.
Age: 63.0
Sex: M
Vaccine: FLU3, FLU3
Symptoms: CSF protein increased, Electromyogram abnormal, Muscular weakness, Myositis
Clinical narrative: Case number PHHY2015US060840 is an initial spontaneous report from a healthcare professional via Vaccine Adverse Event Reporting System (VAERS ID 565305) received on 12 May 2015 with a follow up report from QA department received on 27 May 2015. This report refers to a 63-year-old male patient. Medical history was not reported. Concomitant medications were sleeping pills and XARELTO. He was vaccinated with FLUVIRIN (batch number unknown) in his arm on 19 Dec 2014. Early in Jan 2015 after the vaccination he had weakness lower extremity which was progressing over 2 weeks. On 06 Jan 2015 electromyogram revealed variant GBS (Guillain Barre Syndrome). On 20 Jan 2015 lumbar puncture revealed increased protein (126), 2 WBC with no cells. He was diagnosed with neuropathy myositis. Following the events he visited the emergency room. The final outcome of the events was not recovered. The event were reported as non-serious. Causality was not reported. Seriousness of GBS was upgraded as per the NVS-IME list and neuropathy myositis, lumbar puncture revealed increased protein and weakness lower extremity were upgraded based on available information in the source document. The QA department reported that 66521011710 was not a valid FLUVIRIN batch number hence no investigation will be done without a correct batch number. Follow up report from QA department received on 27 May 2015: Updated QA department's comment.
Age: 63.0
Sex: M
Vaccine: FLU3, FLU3
Symptoms: CSF protein increased, CSF white blood cell count negative, Electromyogram abnormal, Guillain-Barre syndrome, Muscular weakness
Clinical narrative: Case number PHHY2015US060840 is an initial spontaneous report from a healthcare professional via Vaccine Adverse Event Reporting System (VAERS ID 565305) received on 12 May 2015 with a follow up report from QA department received on 27 May 2015. This report refers to a 63-year-old male patient. Medical history was not reported. Concomitant medications were sleeping pills and XARELTO. He was vaccinated with FLUVIRIN (batch number unknown) in his arm on 19 Dec 2014. Early in Jan 2015 after the vaccination he had weakness lower extremity which was progressing over 2 weeks. On 06 Jan 2015 electromyogram revealed variant GBS (Guillain Barre Syndrome). On 20 Jan 2015 lumbar puncture revealed increased protein (126), 2 WBC with no cells. He was diagnosed with neuropathy myositis. Following the events he visited the emergency room. The final outcome of the events was not recovered. The event were reported as non-serious. Causality was not reported. Seriousness of GBS was upgraded as per the NVS-IME list and neuropathy myositis, lumbar puncture revealed increased protein and weakness lower extremity were upgraded based on available information in the source document. The QA department reported that 66521011710 was not a valid FLUVIRIN batch number hence no investigation will be done without a correct batch number. Follow up report from QA department received on 27 May 2015: Updated QA department's comment.
Age: 63.0
Sex: M
Vaccine: FLU3, FLU3
Symptoms: Myositis, Neuropathy peripheral
Clinical narrative: Case number PHHY2015US060840 is an initial spontaneous report from a healthcare professional via Vaccine Adverse Event Reporting System (VAERS ID 565305) received on 12 May 2015 with a follow up report from QA department received on 27 May 2015. This report refers to a 63-year-old male patient. Medical history was not reported. Concomitant medications were sleeping pills and XARELTO. He was vaccinated with FLUVIRIN (batch number unknown) in his arm on 19 Dec 2014. Early in Jan 2015 after the vaccination he had weakness lower extremity which was progressing over 2 weeks. On 06 Jan 2015 electromyogram revealed variant GBS (Guillain Barre Syndrome). On 20 Jan 2015 lumbar puncture revealed increased protein (126), 2 WBC with no cells. He was diagnosed with neuropathy myositis. Following the events he visited the emergency room. The final outcome of the events was not recovered. The event were reported as non-serious. Causality was not reported. Seriousness of GBS was upgraded as per the NVS-IME list and neuropathy myositis, lumbar puncture revealed increased protein and weakness lower extremity were upgraded based on available information in the source document. The QA department reported that 66521011710 was not a valid FLUVIRIN batch number hence no investigation will be done without a correct batch number. Follow up report from QA department received on 27 May 2015: Updated QA department's comment.
Age: 25.0
Sex: M
Vaccine: FLU3, HEP, FLUC3, HEP
Symptoms: Blood test, Computerised tomogram, Coordination abnormal, Electromyogram abnormal, Fall
Clinical narrative: Case number PHHY2015US060006, is an initial spontaneous report received from the Vaccine Adverse Event Reporting System (VAERS, reference number: 567094) website on 12 May 2015 with a follow up report from QA department (QA reference number 1000579) received on 26 May 2015. This report refers to a 25-year-old male patient. Medical history included back pain. No concomitant medication was reported. The patient was vaccinated with FLUCELVAX (batch number: 160234) and ENGERIX B (batch number: 54R55) both on 19 Oct 2014. On the same day after vaccination, he started feeling tired. A week later, he experienced fatigue/tiredness. On 30 Oct 2014, he developed tingling on tongue, fingertips and toes. On 08 Nov 2014, he experienced lack of coordination and he fell at a roller derby. On 12 Nov 2014, he had numbness in leg to groin. On 14 Nov 2014, he was taken to a local emergency room. On 17 Nov 2014, the patient was hospitalized. At hospital magnetic resonance imaging, computerized tomography, spinal tap and blood work were performed (no results were given). Electromyogram showed evidences for the diagnosis of Guillain Barre Syndrome. Treatment was rendered with intravenous immunoglobulins. On 23 Nov 2014, he was discharged from hospital. Final outcome of the events was complete recovery. Causality was not reported. The QA department stated that the batch review was in progress and will be performed with FLUCELVAX since the batch number 160234 belonged to FLUCELVAX. Follow up report from QA department (QA reference number 1000579) received on 26 May 2015: Updated the QA reference number and suspect product from FLUVIRIN to FLUCELVAX.
Age: 25.0
Sex: M
Vaccine: FLU3, HEP, FLUC3, HEP
Symptoms: Fatigue, Guillain-Barre syndrome, Hypoaesthesia, Immunoglobulin therapy, Lumbar puncture
Clinical narrative: Case number PHHY2015US060006, is an initial spontaneous report received from the Vaccine Adverse Event Reporting System (VAERS, reference number: 567094) website on 12 May 2015 with a follow up report from QA department (QA reference number 1000579) received on 26 May 2015. This report refers to a 25-year-old male patient. Medical history included back pain. No concomitant medication was reported. The patient was vaccinated with FLUCELVAX (batch number: 160234) and ENGERIX B (batch number: 54R55) both on 19 Oct 2014. On the same day after vaccination, he started feeling tired. A week later, he experienced fatigue/tiredness. On 30 Oct 2014, he developed tingling on tongue, fingertips and toes. On 08 Nov 2014, he experienced lack of coordination and he fell at a roller derby. On 12 Nov 2014, he had numbness in leg to groin. On 14 Nov 2014, he was taken to a local emergency room. On 17 Nov 2014, the patient was hospitalized. At hospital magnetic resonance imaging, computerized tomography, spinal tap and blood work were performed (no results were given). Electromyogram showed evidences for the diagnosis of Guillain Barre Syndrome. Treatment was rendered with intravenous immunoglobulins. On 23 Nov 2014, he was discharged from hospital. Final outcome of the events was complete recovery. Causality was not reported. The QA department stated that the batch review was in progress and will be performed with FLUCELVAX since the batch number 160234 belonged to FLUCELVAX. Follow up report from QA department (QA reference number 1000579) received on 26 May 2015: Updated the QA reference number and suspect product from FLUVIRIN to FLUCELVAX.
Age: 25.0
Sex: M
Vaccine: FLU3, HEP, FLUC3, HEP
Symptoms: Nuclear magnetic resonance imaging, Paraesthesia, Paraesthesia oral
Clinical narrative: Case number PHHY2015US060006, is an initial spontaneous report received from the Vaccine Adverse Event Reporting System (VAERS, reference number: 567094) website on 12 May 2015 with a follow up report from QA department (QA reference number 1000579) received on 26 May 2015. This report refers to a 25-year-old male patient. Medical history included back pain. No concomitant medication was reported. The patient was vaccinated with FLUCELVAX (batch number: 160234) and ENGERIX B (batch number: 54R55) both on 19 Oct 2014. On the same day after vaccination, he started feeling tired. A week later, he experienced fatigue/tiredness. On 30 Oct 2014, he developed tingling on tongue, fingertips and toes. On 08 Nov 2014, he experienced lack of coordination and he fell at a roller derby. On 12 Nov 2014, he had numbness in leg to groin. On 14 Nov 2014, he was taken to a local emergency room. On 17 Nov 2014, the patient was hospitalized. At hospital magnetic resonance imaging, computerized tomography, spinal tap and blood work were performed (no results were given). Electromyogram showed evidences for the diagnosis of Guillain Barre Syndrome. Treatment was rendered with intravenous immunoglobulins. On 23 Nov 2014, he was discharged from hospital. Final outcome of the events was complete recovery. Causality was not reported. The QA department stated that the batch review was in progress and will be performed with FLUCELVAX since the batch number 160234 belonged to FLUCELVAX. Follow up report from QA department (QA reference number 1000579) received on 26 May 2015: Updated the QA reference number and suspect product from FLUVIRIN to FLUCELVAX.
Age: 60.0
Sex: F
Vaccine: VARZOS
Symptoms: Headache, Injection site erythema, Injection site induration, Injection site warmth
Clinical narrative: Injection site was size of a half dollar, beet red, felt hot, felt tough or hard.  Immediate area surrounding injection site was noticeably pink, about 2.5 inches in diamter.  Annoying headache.
Age: 36.0
Sex: M
Vaccine: HEP
Symptoms: Diplopia, Frequent bowel movements, Headache, Nausea, Rash
Clinical narrative: Employee stated a few hours after receiving the Hep B vaccine he started with a chronic headache, then nausea, increase stools, double vision, light red fine rash to forehead, vomiting was a later symptom, no fever.
Age: 36.0
Sex: M
Vaccine: HEP
Symptoms: Rash erythematous, Vomiting
Clinical narrative: Employee stated a few hours after receiving the Hep B vaccine he started with a chronic headache, then nausea, increase stools, double vision, light red fine rash to forehead, vomiting was a later symptom, no fever.
Age: 52.0
Sex: F
Vaccine: PPV
Symptoms: Bladder dysfunction, Blood test, Cardiac disorder, Electrocardiogram, Electroencephalogram
Clinical narrative: Information has been received from the patient's husband referring to his 52 year old wife, a female patient who was immunocompromised. The patient had no pertinent medical history. On 01-MAY-2011 the patient was vaccinated with a dose of PNEUMOVAX23 (lot#, dose, route not reported). Concomitant therapies included gabapentin, lidocaine (manufacturer unknown) and unspecified thyroid medication. On around 08-MAY-2011 the patient experienced muscle weakness, seizures, vision problems, breathing problems, bowels problems, stomach problems, bladder stop working, passing out, acute respiratory tract infection (ARTI), orthostatic hypotension, heart issue, and her blood work results issues while on PNEUMOVAX23. The patient had been in many unspecified hospitals on several unspecified dates with the latest being at an unspecified hospital for 13 days and "currently" the patient was at an unspecified clinic. Unspecified treatment was given for the events. Unspecified brain scans, unspecified blood work, spinal taps, seizure studies and electrocardiogram (EKGs) were performed and the results were not provided. Outcome of the events was reported as not recovered. The causality was not provided. Upon internal review, seizures was determined to be medically significant. additional information has been requested.
Age: 52.0
Sex: F
Vaccine: PPV
Symptoms: Gastric disorder, Gastrointestinal disorder, Loss of consciousness, Lumbar puncture, Muscular weakness
Clinical narrative: Information has been received from the patient's husband referring to his 52 year old wife, a female patient who was immunocompromised. The patient had no pertinent medical history. On 01-MAY-2011 the patient was vaccinated with a dose of PNEUMOVAX23 (lot#, dose, route not reported). Concomitant therapies included gabapentin, lidocaine (manufacturer unknown) and unspecified thyroid medication. On around 08-MAY-2011 the patient experienced muscle weakness, seizures, vision problems, breathing problems, bowels problems, stomach problems, bladder stop working, passing out, acute respiratory tract infection (ARTI), orthostatic hypotension, heart issue, and her blood work results issues while on PNEUMOVAX23. The patient had been in many unspecified hospitals on several unspecified dates with the latest being at an unspecified hospital for 13 days and "currently" the patient was at an unspecified clinic. Unspecified treatment was given for the events. Unspecified brain scans, unspecified blood work, spinal taps, seizure studies and electrocardiogram (EKGs) were performed and the results were not provided. Outcome of the events was reported as not recovered. The causality was not provided. Upon internal review, seizures was determined to be medically significant. additional information has been requested.