chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Sex: F
Vaccine: VARZOS
Symptoms: Accidental exposure to product, Exposure via direct contact, Eye irrigation, Eye irritation
Clinical narrative: This spontaneous report as received from a nurse refers to a female nurse, age unknown. On 17-NOV-2014 the nurse was withdrawing ZOSTAVAX lot # K008882 from syringe and depressed the plunger which sprayed the ZOSTAVAX into her face and eye. Some of the spray landed on her face and hand and she had an initial burning sensation in her eye. The nurse took her contacts out and used a continuous irrigation in her eye. The patient who was to receive the vaccine did not receive it from that syringe and there was no reported issues with the patient. The outcome of sprayed the ZOSTAVAX product into her eye, with some spray landing on her face and hand and initial burning sensation in her eye is unknown. Additional information has been requested.
Age: 11.0
Sex: U
Vaccine: MMR
Symptoms: Expired product administered, No adverse event
Clinical narrative: This spontaneous report as received from a medical assistant refers to a 11 year old patient of unknown gender. On 05-NOV-2014 the patient was vaccinated with an expired dose of M-M-R II 0.5 ml, subcutaneously in the right arm (lot # H018948, expiration date: 18-OCT-2014). No adverse effects noted. This is one of the reports from the same source. Additional information has been requested.
Sex: U
Vaccine: VARZOS
Symptoms: Herpes zoster
Clinical narrative: This spontaneous report as received from a physician via company representative refers to an approximately 70 years old patient of unknown gender. On unspecified date in approximately 2012 (reported as "2 years ago") the patient was vaccinated with ZOSTAVAX 1 single shot (route, lot # not reported). On an unknown date the patient experienced a mild case of shingles after receiving ZOSTAVAX. The patient sought medical attention by calling to the doctor's office. The patient recovered from a mild case of shingles on unknown date. Relatedness between the event and ZOSTAVAX was not specified. Additional information has been requested.
Age: 72.0
Sex: F
Vaccine: VARZOS
Symptoms: Dyskinesia
Clinical narrative: Information has been received on 19NOV2014 from a pharmacist regarding a 72 year old female with a medical history which included shingles (a year earlier), post-herpetic neuralgia (PHN), Parkinson's disease and asplenia. She was also reported to have allergies to intravenous dyes, Codeine and Tetanus. The pharmacist reported that on 18NOV2014 the patient received ZOSTAVAX (0.65ml subcutaneous) (Lot#/Expiration date K008895/20SEP2015) in her left posterior arm around 2:00PM. Concomitant medication included oxymorphine hydrochloride, CYMBALTA, gabapentin, diflunisal, and VESICARE. The patient notified the pharmacist around 6:00PM by telephone that she was "feeling well." The pharmacist reported that on the morning of 19NOV2014, she received a message from the patient, who said that she "can't move her body." The pharmacist called the patient around 9:00AM on 19NOV2014 and the patient was being taken by emergency medical transport services to an unspecified hospital's emergency department. The pharmacist notified the patient's healthcare provider, who was agreeable to follow-up for additional information. The pharmacist did not know if the patient was going to be admitted to the hospital or how severe her symptoms were. No additional information was provided. Additional information is expected.
Sex: U
Vaccine: VARZOS
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report as received from a pharmacist refers to a patient of unknown age. Current conditions and medical history was not reported On 04-APR-2014, the patient was vaccinated with ZOSTAVAX vial (dose, route, lot number and frequency were not reported). Concomitant medications were not reported. On an unknown date, ZOSTAVAX was exposed to temperature outside the proper storage range and administered to patient on 04-APR-2014. No adverse effect was reported. The outcome was unknown. No further information was provided. Product quality complaint was not reported. Additional information has been requested.
Age: 1.0
Sex: U
Vaccine: VARCEL
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report as received from registered nurse refers to a 1 year old child patient (gender not provided). Patient medical history and other previous drug allergic reactions were not reported. On an unknown date, the patient was vaccinated with VARIVAX (Merck) (dose number, lot number and expiry date unknown), that was exposed to additional temperature excursions since 07-NOV-2014. No adverse events were reported. The registered nurse stated that there were no adverse events reported of the patients who had received the vaccinations. The reporter did not have lot numbers or expiration dates readily available at the time of contact. This is one of several reports received from the same source. Additional information has been requested.
Age: 15.0
Sex: U
Vaccine: MMR
Symptoms: Expired product administered, No adverse event
Clinical narrative: This spontaneous report as received from a medical assistant refers to a 15 year old patient of unknown gender. On 04-NOV-2014 the patient was vaccinated with an expired dose of M-M-R II 0.5 ml, subcutaneously in the right arm (lot # H018948, expiration date: 18-OCT-2014). No adverse effects noted. This is one of several reports from the same source. Additional information has been requested.
Age: 28.0
Sex: M
Vaccine: HPV4
Symptoms: Drug administered to patient of inappropriate age, No adverse event
Clinical narrative: This spontaneous report was received from a 28 year old male consumer. The consumer reported that 9 months prior in approximately MAR-2014 he was vaccinated with GARDASIL at a local pharmacy. The patient reported he was beyond the age of 26 years of age for the vaccination but had no adverse events. Additional information is not expected.
Sex: U
Vaccine: VARCEL
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report as received from a medical assistant refers to an unknown number of patients of unknown age and gender. Information about concurrent conditions, concomitant medication and medical history was not provided. Since 03-NOV-2014, an unknown number of patients have been vaccinated with VARIVAX (Merck) (injection, subcutaneous, lot#, dose and frequency were not provided), that had underwent a supported temperature excursion, (dates unspecified, in approximately 2014). No adverse effect was reported. Additional information has been requested.
Age: 1.0
Sex: F
Vaccine: MMR
Symptoms: Expired product administered, No adverse event
Clinical narrative: This spontaneous report as receive from a medical assistant refers to a 1 year old female patient. On 04-NOV-2014 the patient was vaccinated with an expired dose of M-M-R II 0.5 ml, subcutaneously in the right arm (lot # H018948, expiration date: 18-OCT-2014). No adverse effects noted. This is one of several reports from the same source. Additional information has been requested.
Sex: U
Vaccine: MMRV
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report as received from a nurse on 04-NOV-2014 refers to an unspecified number of patient of unknown age and gender. The nurse reported that since 04-NOV-2014 an unknown doses of PROQUAD (injection, subcutaneous, strength, dose and lot# not reported), which underwent supported temperature excursions, had been administered. No adverse effects was reported. It was unspecified if the patient sought medical attention. This is one of several reports received from the same source. Additional information has been requested.
Age: 65.0
Sex: F
Vaccine: PPV
Symptoms: Malaise, Pain in extremity
Clinical narrative: Pt experienced very sore arm and feeling of malaise.
Age: 52.0
Sex: F
Vaccine: VARZOS
Symptoms: Expired product administered, No adverse event
Clinical narrative: This spontaneous report as received from a health care worker refers to a 54 year old female patient. No medical history was reported. On 02-DEC-2014 the patient was vaccinated with ZOSTAVAX (lot # J007301, 0.65 ml, subcutaneous). On 02-DEC-2014, the reporter stated that client was vaccinated with expired ZOSTAVAX. No adverse effects reported. No product quality complaint was involved. Additional information is not expected. Because the reporter refused additional contact.
Sex: U
Vaccine: VARCEL
Symptoms: Vaccination complication
Clinical narrative: This spontaneous report as received from a medical assistant refers to a currently 15 year old patient of unknown gender. On an unknown date the patient was vaccinated with a dose of VARIVAX (Merck) dose, route, lot# and expiration date were not provided. On an unknown date (it was supported as 'as the patient was little') the patient experienced unspecified reaction post receipt of VARIVAX (Merck). The outcome of the event was not provided. Relatedness between the event and VARIVAX (Merck) was not reported. This case is linked to 1412USA002018 (same patient link). Additional information has been requested.
Sex: U
Vaccine: VARZOS
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report as received from a pharmacist refers to two patients of unknown demographics. On 02-DEC-2014 the patient was vaccinated with ZOSTAVAX (dosing regimen unspecified). No concomitant medications were reported. On 02-DEC-2014, two doses of improperly stored ZOSTAVAX were administered to two patients. No adverse effects were reported. The outcome of two doses of improperly stored ZOSTAVAX were administered and no adverse effects is unknown. There was no product quality complaint involved. Additional information is not expected as the reporter cannot be contacted.
Sex: U
Vaccine: MMR
Symptoms: Expired product administered, No adverse event
Clinical narrative: This spontaneous report as received from a registered nurse refers to a patient of unknown age and gender. On 26-NOV-2014 the patient was inadvertently vaccinated with an expired dose of M-M-R II (lot # H017027, expiration date 14-SEP-2014) subcutaneously (dose not reported). No adverse effects were reported. Additional information has been requested.
Sex: U
Vaccine: HPV4
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report as received from an healthcare worker refers to unspecified patients of unknown ages. Since an unknown date in July 2014, the patients were vaccinated with improperly stored GARDASIL (lot#, strength, dosage, frequency and route unknown). No adverse effects were reported on the reporting time. This is one of several reports received from the same reporter. Additional information has been requested.
Sex: U
Vaccine: HIBV
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report as received from a nurse refers to unspecified number of patients of unknown age and gender. The nurse reported that an unknown number of doses of PEDVAXHIB (dose, lot# and route not reported) that were improperly stored (outside of the range specified in the prescribing information) might have been administered. PEDVAXHIB was exposed to 30F then 48F for 72 hours. No adverse effect was reported. This is one of several reports received from the same source. Additional information has been requested.
Sex: U
Vaccine: HEP
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report as received from an healthcare worker refers to unspecified patients of unknown ages. Since an unknown date in July 2014, the patients were vaccinated with improperly stored RECOMBIVAX HB (lot#, strength, dosage, frequency and route unknown). No adverse effects were reported on the reporting time. This is one of several reports received from the same reporter. Additional information has been requested.
Sex: U
Vaccine: HEPA
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report as received from an healthcare worker refers to unspecified patients of unknown ages. Since an unknown dates in July 2014 the patients were vaccinated with improperly stored VAQTA (lot#, strength, dosage, frequency and route unknown). No adverse effects were reported on the reporting time. This is one of several reports received from the same reporter. Additional information has been requested.
Age: 1.0
Sex: F
Vaccine: MMR
Symptoms: Expired product administered
Clinical narrative: This spontaneous report as received from the office manager refers to a 12 month old female patient. Pertinent medical history was unknown. On 02-DEC-2014 the patient was vaccinated with M-M-R II (lot#H01A4A4, Expiry date: 10-May-2014, anatomical location was reported as left leg, frequency was reported as once, route of administration and therapy type was unknown) which was expired. Concomitant medications were unspecified by reporter. It was unknown of there was any relevant laboratory data. The outcome of the event was unknown. The reporter also stated that it was unknown if the patient would receive another M-M-R II. Additional information has been requested.
Age: 75.0
Sex: F
Vaccine: PPV
Symptoms: Injection site erythema, Injection site pruritus, Injection site swelling, Injection site warmth
Clinical narrative: (L) upper arm swollen and red warm to touch and c/o itchy. BENADRYL 25 mg IM given today. 13 cm x 13 cm area.
Sex: U
Vaccine: MMRV
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report as received from a nurse refers to an unspecified multiple patients of unknown age and gender. On an unknown date the patients were vaccinated with PROQUAD (Merck) (route, dose, frequency and lot # not reported) that was improperly stored. No adverse effects reported. This is one of several reports from the same source. Additional information has been requested.
Sex: U
Vaccine: VARZOS
Symptoms: Injection site pain
Clinical narrative: This spontaneous report as received from a pharmacist via a company representative refers to an unspecified patient of unknown age and gender. On an unknown date the patient was vaccinated with a dose of ZOSTAVAX (lot#, dose unspecified, subcutaneous, indication reported as "age-based, it was recommended"). Concomitant medications were unspecified. On an unknown date the patient experienced a "burning sensation" at the injection site. The outcome of the event was unknown. No PQC was involved. 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 nurse refers to an unspecified multiple patients of unknown age and gender. On an unknown date the patients were vaccinated with VARIVAX (Merck) (route, dose, frequency and lot # not reported) that was improperly stored. No adverse effects reported. This is one of several reports from the same source. Additional information has been requested.
Age: 76.0
Sex: F
Vaccine: PNC13
Symptoms: Vaccination site cellulitis, Vaccination site erythema
Clinical narrative: Erythema noted below vaccine site 4 days after PREVNAR injection. Appeared to be cellulitis, antibiotics prescribed.
Age: 85.0
Sex: M
Vaccine: TDAP
Symptoms: Mobility decreased, Pain
Clinical narrative: Severe pain, unable to lift arm.
Age: 68.0
Sex: M
Vaccine: TDAP
Symptoms: Mobility decreased, Pain
Clinical narrative: Severe pain, unable to lift arm.
Sex: F
Vaccine: VARZOS
Symptoms: Injection site pruritus, Injection site reaction, Injection site swelling, Injection site warmth
Clinical narrative: This spontaneous report was received from a female patient of unknown age who is a nurse, via field representative. Patient's concurrent conditions and relevant medical history was not reported. On an unknown date the patient was vaccinated with ZOSTAVAX (dose, frequency and route unspecified). Concomitant medications were not reported. On an unknown date the patient experienced injection site reaction which included itching, injection site warmth and swelling. The patient did not sought medical attention. The patient was treated with ALEVE. The outcome of itching, injection site warmth and swelling was reported as recovering/resolving. The causality of the events with ZOSTAVAX was not reported. Additional information has been requested.
Sex: U
Vaccine: VARZOS
Symptoms: Bone pain
Clinical narrative: This spontaneous report as received from a health care student refers to a patient of unknown age. The patient's pertinent medical history was not reported. On 20-NOV-2014 the patient was vaccinated with ZOSTAVAX, intramuscularly ay an unspecified pharmacy (reported as came to pharmacy on 30-NOV-2014 to report). On an unknown date the patient experienced bone pain. Cancer and overdose was not reported. Product quality complaint was not involved. The outcome of bone pain was reported as not recovered/not resolved. Causality was unknown. Additional information has been requested.
Age: 5.0
Sex: F
Vaccine: DTAP, IPV, MMRV
Symptoms: Rash erythematous
Clinical narrative: Rash on leg, red, about 5-8 cm target-like appearance.
Sex: U
Vaccine: PPV
Symptoms: Expired product administered, No adverse event
Clinical narrative: This spontaneous report as received from a nurse refers to a patient of unknown age. On 03-NOV-2014 the patient was vaccinated with a dose of 0.5 ml PNEUMOVAX 23, (lot # unspecified, expiration date 26-SEP-2014), intramuscular. No adverse effect was reported. Additional information has been requested.
Sex: U
Vaccine: HPV4
Symptoms: Inappropriate schedule of drug administration, No adverse event
Clinical narrative: This spontaneous report as received from a physician refers to a patient of unknown age. In September 2013 the patient was vaccinated with the first dose of GARDASIL, injection, (lot #, expired date, dose and route unspecified). On 02-DEC-2014 (at the reporting day) the patient was vaccinated with the second dose of GARDASIL, injection, (lot #, expired date, dose and route unspecified). No adverse effects reported. Additional information has been requested.
Sex: F
Vaccine: PPV
Symptoms: Injection site pain, Injection site swelling
Clinical narrative: This spontaneous report as received from a nurse practitioner via a field representative refers to a 40-50 year old female patient. On 12-NOV-2014, the patient was vaccinated with a dose of PNEUMOVAX 23 (dose, lot# and route not reported) 1 single shot. On approximately 29-OCT-2014 (reported as 2 weeks prior to receiving PNEUMOVAX 23), the patient received an unspecified influenza virus vaccine (manufacturer unknown). On 15-NOV-2014, 3 days after receiving PNEUMOVAX 23 the patient experienced swelling and pain near the injection site. The patient sought unspecified medical attention. Unspecified antibiotics was given for adverse event. No lab diagnostics studies were performed. The outcome of the event was unknown. Additional information has been requested.
Sex: F
Vaccine: HPV4
Symptoms: Interchange of vaccine products, No adverse event
Clinical narrative: This spontaneous report as received from a nurse via a field representative refers to a female patient of unknown age. Information about concurrent conditions and medical history was not provided. Approximately in 2012, reported as two years ago patient was vaccinated with two doses of CERVARIX (strength, route, dose, lot, batch # and expiration date not reported) and one dose of GARDASIL (strength, route, dose, lot, batch # and expiration date not reported). Concomitant therapies were not reported. No adverse event reported at time of intake. Adverse event taking as CERVAIRX was not part of the GARDASIL prescribing information. The outcome of the event was unknown. Additional information is not expected because the nurse did not want to be contacted.
Age: 0.1
Sex: U
Vaccine: HIBV
Symptoms: Drug administered to patient of inappropriate age, No adverse event
Clinical narrative: This spontaneous report as received from a licensed vocational nurse refers to a 6-week-old patient of unknown gender. Information about concurrent conditions and medical history was not provided. On an unknown date the patient was vaccinated with PEDVAXHIB (dose, route, lot number and expiration date not reported). Concomitant therapies were not reported. No adverse effect reported. Additional information has been requested.
Age: 18.0
Sex: U
Vaccine: HEP, IPV, MMR, HEP, IPV, MMR, TD
Symptoms: Lymphadenopathy, Swelling face
Clinical narrative: Swelling of gland in the cheek. I am currently on medication KEFLEX 250 m.g. Difficulty breathing. I am on medication-inhaler FLOVENT.
Age: 18.0
Sex: U
Vaccine: HEP, IPV, MMR, HEP, IPV, MMR, TD
Symptoms: Dyspnoea, Salivary gland enlargement
Clinical narrative: Swelling of gland in the cheek. I am currently on medication KEFLEX 250 m.g. Difficulty breathing. I am on medication-inhaler FLOVENT.
Age: 11.0
Sex: F
Vaccine: HPV4, MNQ, TDAP, HPV4, MNQ, TDAP
Symptoms: Cellulitis, Injection site erythema, Injection site pain, Injection site warmth
Clinical narrative: Case number PHHY2014US149776 is an initial spontaneous report received via the Vaccine Adverse Event Reporting System (VAERS reference number: 538536) website on 13 Nov 2014, with a follow-up report received from Quality Assurance Department (reference number: 338153) on 19 Nov 2014, with the follow-up information received from Quality Assurance Department (reference number: 338153) on 02 Dec 2014. This report refers to an 11 years old female patient. Her medical history and concomitant medications were not reported. She was vaccinated with MENVEO (batch number: M13014 and expiry date: Sep 2014) intramuscularly in the right arm, GARDASIL (other manufacturer, batch number: K001500) intramuscularly in the left leg and BOOSTRIX (other manufacturer, batch number: XP4D) intramuscularly in the left arm; all vaccines administered on 01 Aug 2014. On 02 Aug 2014, she experienced cellulitis secondary to shots. She experienced redness, warmth and tenderness in the injection site of both arms and it spread to an area of one and half inches in the right arm and 1 inch in the left arm. She went to emergency room and was treated with BACTRIM DS 1/2 twice daily for 10 days. The final outcome was reported as complete recovery. The events were reported non-serious, but the events were upgraded as medically significant based on the information available on NVS-IME list and NVx key event list. The causality of the event was not reported. Based on the investigation performed, the QA department stated that, MENVEO vaccine (batch number: M13014) was manufactured in accordance with the approved internal procedures and it was in compliance with the cGMP requirements. Non-significant follow-up report received from the Quality Assurance Department (reference number: 338153) on 19 Nov 2014: Updated QA number. Follow-up information received from the Quality Assurance Department (reference number: 338153) on 02 Dec 2014: Updated MENVEO expiry date (Sep 2014) and batch review report.
Age: 11.0
Sex: F
Vaccine: HPV4, MNQ, TDAP, HPV4, MNQ, TDAP
Symptoms: Cellulitis, Injection site erythema, Injection site pain, Injection site warmth, Vaccination complication
Clinical narrative: Case number PHHY2014US149776 is an initial spontaneous report received via the Vaccine Adverse Event Reporting System (VAERS reference number: 538536) website on 13 Nov 2014, with a follow-up report received from Quality Assurance Department (reference number: 338153) on 19 Nov 2014, with the follow-up information received from Quality Assurance Department (reference number: 338153) on 02 Dec 2014. This report refers to an 11 years old female patient. Her medical history and concomitant medications were not reported. She was vaccinated with MENVEO (batch number: M13014 and expiry date: Sep 2014) intramuscularly in the right arm, GARDASIL (other manufacturer, batch number: K001500) intramuscularly in the left leg and BOOSTRIX (other manufacturer, batch number: XP4D) intramuscularly in the left arm; all vaccines administered on 01 Aug 2014. On 02 Aug 2014, she experienced cellulitis secondary to shots. She experienced redness, warmth and tenderness in the injection site of both arms and it spread to an area of one and half inches in the right arm and 1 inch in the left arm. She went to emergency room and was treated with BACTRIM DS 1/2 twice daily for 10 days. The final outcome was reported as complete recovery. The events were reported non-serious, but the events were upgraded as medically significant based on the information available on NVS-IME list and NVx key event list. The causality of the event was not reported. Based on the investigation performed, the QA department stated that, MENVEO vaccine (batch number: M13014) was manufactured in accordance with the approved internal procedures and it was in compliance with the cGMP requirements. Non-significant follow-up report received from the Quality Assurance Department (reference number: 338153) on 19 Nov 2014: Updated QA number. Follow-up information received from the Quality Assurance Department (reference number: 338153) on 02 Dec 2014: Updated MENVEO expiry date (Sep 2014) and batch review report.
Age: 16.0
Sex: F
Vaccine: MNQ, MNQ
Symptoms: Abasia, Asthenia, Back pain, Computerised tomogram, Dizziness
Clinical narrative: Case number PHHY2014US153219, is an initial spontaneous report received from the Vaccine Adverse Event Reporting System (VAERS, reference number: 541904) website on 13 Nov 2014, with the follow-up information received from Quality Assurance Department on 03 Dec 2014. This report refers to a 16 year old female patient. Her historical and current condition was none. Concomitant medications included levothyroxine 225 mcg and ADDERALL 10 mg. She was vaccinated with MENVEO (batch number: unknown) intramuscularly in left arm on 21 Aug 2014. On the same day after vaccination, she was not feeling well and then blacked out. She continued to feel lightheaded/dizzy, spacey and slightly weak for the next 04 days. She "began decreasing with weakness" and developed numbness, tingling in legs and back and severe shooting pain. She could not walk. The patient was taken to emergency room on 24 Aug 2014. She was hospitalized and stayed in medical care. Patient was then transferred to another hospital. On an unknown date, nuclear magnetic resonance imaging, CAT scan, spinal tap, EKG and multiple lab tests were performed (no results given). Total duration of hospitalization was 09 days. Final outcome was unknown. Causality was not reported. Upon the follow-up from QA department, it was stated that, the reported MENVEO batch number: AT4031 is not a valid batch number; hence QA investigation would not be performed. Follow-up information received from Quality Assurance Department on 03 Dec 2014: Updated QA comments about the MENVEO batch number and no QA investigation would be performed.
Age: 16.0
Sex: F
Vaccine: MNQ, MNQ
Symptoms: Electrocardiogram, Feeling abnormal, Hypoaesthesia, Laboratory test, Loss of consciousness
Clinical narrative: Case number PHHY2014US153219, is an initial spontaneous report received from the Vaccine Adverse Event Reporting System (VAERS, reference number: 541904) website on 13 Nov 2014, with the follow-up information received from Quality Assurance Department on 03 Dec 2014. This report refers to a 16 year old female patient. Her historical and current condition was none. Concomitant medications included levothyroxine 225 mcg and ADDERALL 10 mg. She was vaccinated with MENVEO (batch number: unknown) intramuscularly in left arm on 21 Aug 2014. On the same day after vaccination, she was not feeling well and then blacked out. She continued to feel lightheaded/dizzy, spacey and slightly weak for the next 04 days. She "began decreasing with weakness" and developed numbness, tingling in legs and back and severe shooting pain. She could not walk. The patient was taken to emergency room on 24 Aug 2014. She was hospitalized and stayed in medical care. Patient was then transferred to another hospital. On an unknown date, nuclear magnetic resonance imaging, CAT scan, spinal tap, EKG and multiple lab tests were performed (no results given). Total duration of hospitalization was 09 days. Final outcome was unknown. Causality was not reported. Upon the follow-up from QA department, it was stated that, the reported MENVEO batch number: AT4031 is not a valid batch number; hence QA investigation would not be performed. Follow-up information received from Quality Assurance Department on 03 Dec 2014: Updated QA comments about the MENVEO batch number and no QA investigation would be performed.
Age: 16.0
Sex: F
Vaccine: MNQ, MNQ
Symptoms: Lumbar puncture, Malaise, Nuclear magnetic resonance imaging, Pain, Paraesthesia
Clinical narrative: Case number PHHY2014US153219, is an initial spontaneous report received from the Vaccine Adverse Event Reporting System (VAERS, reference number: 541904) website on 13 Nov 2014, with the follow-up information received from Quality Assurance Department on 03 Dec 2014. This report refers to a 16 year old female patient. Her historical and current condition was none. Concomitant medications included levothyroxine 225 mcg and ADDERALL 10 mg. She was vaccinated with MENVEO (batch number: unknown) intramuscularly in left arm on 21 Aug 2014. On the same day after vaccination, she was not feeling well and then blacked out. She continued to feel lightheaded/dizzy, spacey and slightly weak for the next 04 days. She "began decreasing with weakness" and developed numbness, tingling in legs and back and severe shooting pain. She could not walk. The patient was taken to emergency room on 24 Aug 2014. She was hospitalized and stayed in medical care. Patient was then transferred to another hospital. On an unknown date, nuclear magnetic resonance imaging, CAT scan, spinal tap, EKG and multiple lab tests were performed (no results given). Total duration of hospitalization was 09 days. Final outcome was unknown. Causality was not reported. Upon the follow-up from QA department, it was stated that, the reported MENVEO batch number: AT4031 is not a valid batch number; hence QA investigation would not be performed. Follow-up information received from Quality Assurance Department on 03 Dec 2014: Updated QA comments about the MENVEO batch number and no QA investigation would be performed.
Age: 16.0
Sex: F
Vaccine: MNQ, MNQ
Symptoms: Abasia, Asthenia, Computerised tomogram, Dizziness, Electrocardiogram
Clinical narrative: Case number PHHY2014US153219, is an initial spontaneous report received from the Vaccine Adverse Event Reporting System (VAERS, reference number: 541904) website on 13 Nov 2014, with the follow-up information received from Quality Assurance Department on 03 Dec 2014. This report refers to a 16 year old female patient. Her historical and current condition was none. Concomitant medications included levothyroxine 225 mcg and ADDERALL 10 mg. She was vaccinated with MENVEO (batch number: unknown) intramuscularly in left arm on 21 Aug 2014. On the same day after vaccination, she was not feeling well and then blacked out. She continued to feel lightheaded/dizzy, spacey and slightly weak for the next 04 days. She "began decreasing with weakness" and developed numbness, tingling in legs and back and severe shooting pain. She could not walk. The patient was taken to emergency room on 24 Aug 2014. She was hospitalized and stayed in medical care. Patient was then transferred to another hospital. On an unknown date, nuclear magnetic resonance imaging, CAT scan, spinal tap, EKG and multiple lab tests were performed (no results given). Total duration of hospitalization was 09 days. Final outcome was unknown. Causality was not reported. Upon the follow-up from QA department, it was stated that, the reported MENVEO batch number: AT4031 is not a valid batch number; hence QA investigation would not be performed. Follow-up information received from Quality Assurance Department on 03 Dec 2014: Updated QA comments about the MENVEO batch number and no QA investigation would be performed.
Age: 16.0
Sex: F
Vaccine: MNQ, MNQ
Symptoms: Feeling abnormal, Hypoaesthesia, Laboratory test, Loss of consciousness, Lumbar puncture
Clinical narrative: Case number PHHY2014US153219, is an initial spontaneous report received from the Vaccine Adverse Event Reporting System (VAERS, reference number: 541904) website on 13 Nov 2014, with the follow-up information received from Quality Assurance Department on 03 Dec 2014. This report refers to a 16 year old female patient. Her historical and current condition was none. Concomitant medications included levothyroxine 225 mcg and ADDERALL 10 mg. She was vaccinated with MENVEO (batch number: unknown) intramuscularly in left arm on 21 Aug 2014. On the same day after vaccination, she was not feeling well and then blacked out. She continued to feel lightheaded/dizzy, spacey and slightly weak for the next 04 days. She "began decreasing with weakness" and developed numbness, tingling in legs and back and severe shooting pain. She could not walk. The patient was taken to emergency room on 24 Aug 2014. She was hospitalized and stayed in medical care. Patient was then transferred to another hospital. On an unknown date, nuclear magnetic resonance imaging, CAT scan, spinal tap, EKG and multiple lab tests were performed (no results given). Total duration of hospitalization was 09 days. Final outcome was unknown. Causality was not reported. Upon the follow-up from QA department, it was stated that, the reported MENVEO batch number: AT4031 is not a valid batch number; hence QA investigation would not be performed. Follow-up information received from Quality Assurance Department on 03 Dec 2014: Updated QA comments about the MENVEO batch number and no QA investigation would be performed.
Age: 16.0
Sex: F
Vaccine: MNQ, MNQ
Symptoms: Malaise, Nuclear magnetic resonance imaging, Pain, Paraesthesia
Clinical narrative: Case number PHHY2014US153219, is an initial spontaneous report received from the Vaccine Adverse Event Reporting System (VAERS, reference number: 541904) website on 13 Nov 2014, with the follow-up information received from Quality Assurance Department on 03 Dec 2014. This report refers to a 16 year old female patient. Her historical and current condition was none. Concomitant medications included levothyroxine 225 mcg and ADDERALL 10 mg. She was vaccinated with MENVEO (batch number: unknown) intramuscularly in left arm on 21 Aug 2014. On the same day after vaccination, she was not feeling well and then blacked out. She continued to feel lightheaded/dizzy, spacey and slightly weak for the next 04 days. She "began decreasing with weakness" and developed numbness, tingling in legs and back and severe shooting pain. She could not walk. The patient was taken to emergency room on 24 Aug 2014. She was hospitalized and stayed in medical care. Patient was then transferred to another hospital. On an unknown date, nuclear magnetic resonance imaging, CAT scan, spinal tap, EKG and multiple lab tests were performed (no results given). Total duration of hospitalization was 09 days. Final outcome was unknown. Causality was not reported. Upon the follow-up from QA department, it was stated that, the reported MENVEO batch number: AT4031 is not a valid batch number; hence QA investigation would not be performed. Follow-up information received from Quality Assurance Department on 03 Dec 2014: Updated QA comments about the MENVEO batch number and no QA investigation would be performed.
Age: 24.0
Sex: F
Vaccine: RAB, RAB, RAB, RAB
Symptoms: Amnesia, Blood test normal, Chest X-ray normal, Chest discomfort, Fatigue
Clinical narrative: Case number PHHY2014US158349, is an initial spontaneous report received from a consumer via Vaccine Adverse Event Reporting System (VAERS reference number: 544922) website on 28 Nov 2014. This report refers to a 24-year-old female patient. Her concomitant drugs included doxycycline and spironolactone. She was vaccinated with first dose of rabies vaccine on 15 Sep 2014 and experienced numbness over entire body including face, tunnel vision, blurred vision, muscle weakness, 103 fever, short term memory loss, extreme fatigue, headaches and tightness in chest (see case: PHHY2014US158327). She received flu vaccine (manufacturer and batch number: not reported) on 16 Sep 2014 in the right arm. On 22 Sep 2014, she received her second dose of rabies vaccine (manufacturer and batch number: not reported). On the same date, after vaccinations the symptoms (numbness over entire body including face, tunnel vision, blurred vision, muscle weakness, 103 fever, short term memory loss, extreme fatigue, headaches and tightness in chest) of the patient worsened. At 02:40 pm, the patient visited the emergency room and underwent blood work, urinalysis and chest x-ray which showed normal results. It was reported that the patient had a very bad vaccine reaction and needed to report it and as well as follow up with a neurologist. The outcome of the events reported as worsened. The events reported as non-serious. Seriousness assessment of the events (tunnel vision, blurred vision, short term memory loss and tightness in chest) was upgraded based on the available information in the source document. The causality of the events was not reported.
Age: 24.0
Sex: F
Vaccine: RAB, RAB, RAB, RAB
Symptoms: Headache, Hypoaesthesia, Muscular weakness, Pyrexia, Tunnel vision
Clinical narrative: Case number PHHY2014US158349, is an initial spontaneous report received from a consumer via Vaccine Adverse Event Reporting System (VAERS reference number: 544922) website on 28 Nov 2014. This report refers to a 24-year-old female patient. Her concomitant drugs included doxycycline and spironolactone. She was vaccinated with first dose of rabies vaccine on 15 Sep 2014 and experienced numbness over entire body including face, tunnel vision, blurred vision, muscle weakness, 103 fever, short term memory loss, extreme fatigue, headaches and tightness in chest (see case: PHHY2014US158327). She received flu vaccine (manufacturer and batch number: not reported) on 16 Sep 2014 in the right arm. On 22 Sep 2014, she received her second dose of rabies vaccine (manufacturer and batch number: not reported). On the same date, after vaccinations the symptoms (numbness over entire body including face, tunnel vision, blurred vision, muscle weakness, 103 fever, short term memory loss, extreme fatigue, headaches and tightness in chest) of the patient worsened. At 02:40 pm, the patient visited the emergency room and underwent blood work, urinalysis and chest x-ray which showed normal results. It was reported that the patient had a very bad vaccine reaction and needed to report it and as well as follow up with a neurologist. The outcome of the events reported as worsened. The events reported as non-serious. Seriousness assessment of the events (tunnel vision, blurred vision, short term memory loss and tightness in chest) was upgraded based on the available information in the source document. The causality of the events was not reported.
Age: 24.0
Sex: F
Vaccine: RAB, RAB, RAB, RAB
Symptoms: Urine analysis normal, Vaccination complication, Vision blurred
Clinical narrative: Case number PHHY2014US158349, is an initial spontaneous report received from a consumer via Vaccine Adverse Event Reporting System (VAERS reference number: 544922) website on 28 Nov 2014. This report refers to a 24-year-old female patient. Her concomitant drugs included doxycycline and spironolactone. She was vaccinated with first dose of rabies vaccine on 15 Sep 2014 and experienced numbness over entire body including face, tunnel vision, blurred vision, muscle weakness, 103 fever, short term memory loss, extreme fatigue, headaches and tightness in chest (see case: PHHY2014US158327). She received flu vaccine (manufacturer and batch number: not reported) on 16 Sep 2014 in the right arm. On 22 Sep 2014, she received her second dose of rabies vaccine (manufacturer and batch number: not reported). On the same date, after vaccinations the symptoms (numbness over entire body including face, tunnel vision, blurred vision, muscle weakness, 103 fever, short term memory loss, extreme fatigue, headaches and tightness in chest) of the patient worsened. At 02:40 pm, the patient visited the emergency room and underwent blood work, urinalysis and chest x-ray which showed normal results. It was reported that the patient had a very bad vaccine reaction and needed to report it and as well as follow up with a neurologist. The outcome of the events reported as worsened. The events reported as non-serious. Seriousness assessment of the events (tunnel vision, blurred vision, short term memory loss and tightness in chest) was upgraded based on the available information in the source document. The causality of the events was not reported.
Age: 24.0
Sex: F
Vaccine: RAB, RAB, RAB, RAB
Symptoms: Amnesia, Blood test, Chest X-ray, Dizziness, Fatigue
Clinical narrative: Case number PHHY2014US158349, is an initial spontaneous report received from a consumer via Vaccine Adverse Event Reporting System (VAERS reference number: 544922) website on 28 Nov 2014. This report refers to a 24-year-old female patient. Her concomitant drugs included doxycycline and spironolactone. She was vaccinated with first dose of rabies vaccine on 15 Sep 2014 and experienced numbness over entire body including face, tunnel vision, blurred vision, muscle weakness, 103 fever, short term memory loss, extreme fatigue, headaches and tightness in chest (see case: PHHY2014US158327). She received flu vaccine (manufacturer and batch number: not reported) on 16 Sep 2014 in the right arm. On 22 Sep 2014, she received her second dose of rabies vaccine (manufacturer and batch number: not reported). On the same date, after vaccinations the symptoms (numbness over entire body including face, tunnel vision, blurred vision, muscle weakness, 103 fever, short term memory loss, extreme fatigue, headaches and tightness in chest) of the patient worsened. At 02:40 pm, the patient visited the emergency room and underwent blood work, urinalysis and chest x-ray which showed normal results. It was reported that the patient had a very bad vaccine reaction and needed to report it and as well as follow up with a neurologist. The outcome of the events reported as worsened. The events reported as non-serious. Seriousness assessment of the events (tunnel vision, blurred vision, short term memory loss and tightness in chest) was upgraded based on the available information in the source document. The causality of the events was not reported.
Age: 24.0
Sex: F
Vaccine: RAB, RAB, RAB, RAB
Symptoms: Headache, Hypoaesthesia, Muscular weakness, Paraesthesia, Tunnel vision
Clinical narrative: Case number PHHY2014US158349, is an initial spontaneous report received from a consumer via Vaccine Adverse Event Reporting System (VAERS reference number: 544922) website on 28 Nov 2014. This report refers to a 24-year-old female patient. Her concomitant drugs included doxycycline and spironolactone. She was vaccinated with first dose of rabies vaccine on 15 Sep 2014 and experienced numbness over entire body including face, tunnel vision, blurred vision, muscle weakness, 103 fever, short term memory loss, extreme fatigue, headaches and tightness in chest (see case: PHHY2014US158327). She received flu vaccine (manufacturer and batch number: not reported) on 16 Sep 2014 in the right arm. On 22 Sep 2014, she received her second dose of rabies vaccine (manufacturer and batch number: not reported). On the same date, after vaccinations the symptoms (numbness over entire body including face, tunnel vision, blurred vision, muscle weakness, 103 fever, short term memory loss, extreme fatigue, headaches and tightness in chest) of the patient worsened. At 02:40 pm, the patient visited the emergency room and underwent blood work, urinalysis and chest x-ray which showed normal results. It was reported that the patient had a very bad vaccine reaction and needed to report it and as well as follow up with a neurologist. The outcome of the events reported as worsened. The events reported as non-serious. Seriousness assessment of the events (tunnel vision, blurred vision, short term memory loss and tightness in chest) was upgraded based on the available information in the source document. The causality of the events was not reported.
Age: 24.0
Sex: F
Vaccine: RAB, RAB, RAB, RAB
Symptoms: Urine analysis, Vision blurred
Clinical narrative: Case number PHHY2014US158349, is an initial spontaneous report received from a consumer via Vaccine Adverse Event Reporting System (VAERS reference number: 544922) website on 28 Nov 2014. This report refers to a 24-year-old female patient. Her concomitant drugs included doxycycline and spironolactone. She was vaccinated with first dose of rabies vaccine on 15 Sep 2014 and experienced numbness over entire body including face, tunnel vision, blurred vision, muscle weakness, 103 fever, short term memory loss, extreme fatigue, headaches and tightness in chest (see case: PHHY2014US158327). She received flu vaccine (manufacturer and batch number: not reported) on 16 Sep 2014 in the right arm. On 22 Sep 2014, she received her second dose of rabies vaccine (manufacturer and batch number: not reported). On the same date, after vaccinations the symptoms (numbness over entire body including face, tunnel vision, blurred vision, muscle weakness, 103 fever, short term memory loss, extreme fatigue, headaches and tightness in chest) of the patient worsened. At 02:40 pm, the patient visited the emergency room and underwent blood work, urinalysis and chest x-ray which showed normal results. It was reported that the patient had a very bad vaccine reaction and needed to report it and as well as follow up with a neurologist. The outcome of the events reported as worsened. The events reported as non-serious. Seriousness assessment of the events (tunnel vision, blurred vision, short term memory loss and tightness in chest) was upgraded based on the available information in the source document. The causality of the events was not reported.
Age: 24.0
Sex: F
Vaccine: RAB, RAB, RAB, RAB
Symptoms: Amnesia, Drug screen, Fatigue, Full blood count, Headache
Clinical narrative: Case number PHHY2014US158349, is an initial spontaneous report received from a consumer via Vaccine Adverse Event Reporting System (VAERS reference number: 544922) website on 28 Nov 2014. This report refers to a 24-year-old female patient. Her concomitant drugs included doxycycline and spironolactone. She was vaccinated with first dose of rabies vaccine on 15 Sep 2014 and experienced numbness over entire body including face, tunnel vision, blurred vision, muscle weakness, 103 fever, short term memory loss, extreme fatigue, headaches and tightness in chest (see case: PHHY2014US158327). She received flu vaccine (manufacturer and batch number: not reported) on 16 Sep 2014 in the right arm. On 22 Sep 2014, she received her second dose of rabies vaccine (manufacturer and batch number: not reported). On the same date, after vaccinations the symptoms (numbness over entire body including face, tunnel vision, blurred vision, muscle weakness, 103 fever, short term memory loss, extreme fatigue, headaches and tightness in chest) of the patient worsened. At 02:40 pm, the patient visited the emergency room and underwent blood work, urinalysis and chest x-ray which showed normal results. It was reported that the patient had a very bad vaccine reaction and needed to report it and as well as follow up with a neurologist. The outcome of the events reported as worsened. The events reported as non-serious. Seriousness assessment of the events (tunnel vision, blurred vision, short term memory loss and tightness in chest) was upgraded based on the available information in the source document. The causality of the events was not reported.