chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 22.0
Sex: M
Vaccine: TTOX
Symptoms: Nausea, Pallor, Thirst
Clinical narrative: Immediately, post tetanus immunization, donor report seeing "stars." Within less than 1 min, donor complained of nausea, thirst, and lightheadedness. Donor also presented with sweating, pallor, and warmth/chills. No emesis, LOC or respiratory problems at any point. Donor sat bent forward in chair and given 8 oz water per donor's request. Donor moved from original seated position to side-lying position on exam table and given wrapped ice packs on chest and back of neck. VS taken at 11:21 (57BPM, 95/47), 11:29 (58BPM, 108/60), 11:39 (57BPM, 124/69). Donor was 100% recovered by 11:45. Donor ate cookies and fluids at this time w/o complaint/nausea and ambulated w/o dizziness. Donor states feels "100%" prior to departure.
Age: 47.0
Sex: F
Vaccine: FLUX
Symptoms: Pruritus, Throat irritation, Urticaria
Clinical narrative: Started with itching, arms, legs, torso. Hives developed. Itchy throat all within approx. 45min to 1 hour. Took a antihistamine.
Age: 51.0
Sex: M
Vaccine: FLU3
Symptoms: Guillain-Barre syndrome, Hypoaesthesia, Immunoglobulin therapy, Intensive care, Life support
Clinical narrative: 6 days post immunization, patient develops vision issues, numbness in extremities. Hospitalized on 01/03/2013. Moved to IC on 01/06/2013. Released from hospital 01/28/2013. Followed up with in home physical rehab. Diagnosis (via patient) was Guillan Barre.
Age: 51.0
Sex: M
Vaccine: FLU3
Symptoms: Visual impairment
Clinical narrative: 6 days post immunization, patient develops vision issues, numbness in extremities. Hospitalized on 01/03/2013. Moved to IC on 01/06/2013. Released from hospital 01/28/2013. Followed up with in home physical rehab. Diagnosis (via patient) was Guillan Barre.
Age: 59.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site erythema, Injection site inflammation, Injection site swelling
Clinical narrative: Pt had a red circle around the arm at injection site. Pt got a prescription for clindamycin from the MD. The circle was inflamed and enlarged another day, patient will start antibiotics today (4/14).
Age: 11.0
Sex: M
Vaccine: TDAP
Symptoms: Dizziness, Fall, Hyperhidrosis, Somnolence
Clinical narrative: Pt fainted within a couple of minutes of administration of vaccine. Pt was brought back to seat after falling. (Did not hit head). Pt was awake but sweating profusely, dizzy and sleepy. Pt was given water to drink, wiped with a wet towel and fanned down. After 25 min. pt was feeling much better and was able to leave with family.
Age: 86.0
Sex: M
Vaccine: HEP
Symptoms: Expired drug administered, No adverse event
Clinical narrative: This spontaneous report as received from a nurse refers to a 86 year old male patient. On 01-APR-2013 the patient was intramuscularly vaccinated with RECOMBIVAX HB, dialysis dose of 40 mcg/ml (lot # 0406AE, expiry date 25-MAR-2013) on his right deltoid. No adverse effects reported. It was unspecified if the patient had sought medical attention. Additional information has been requested.
Age: 31.0
Sex: M
Vaccine: FLU3, PPV
Symptoms: Cellulitis, Pyrexia, Sepsis
Clinical narrative: Case number PHHY2013US012054 is an initial spontaneous report received from vaccine adverse event reporting system website (VAERS reference number: 474949) on 08 Feb 2013 and a follow up received from the quality assurance department (quality reference number: 209862) on 11 Apr 2013. This case refers to a 31-year-old male patient. His medical history and concomitant medications were not reported. He was vaccinated with FLUVIRIN (batch number: 1205001) intramuscularly in his left arm on 20 Oct 2012. On the same day he was also vaccinated with PNEUMOVAX (other manufacturer, batch number: 1706AA) intramuscularly in left arm. On 20 Oct 2012 eight hours after vaccination he presented with fever which rose to 104 degrees by the next morning. He went to hospital where he was diagnosed with cellulitis and sepsis. He was kept under treatment for 4 days. The final outcome was reported as completely recovered. The seriousness and causality were not reported. No other information was available. Based on the batch review report it was confirmed that the FLUVIRIN batch 1205001 was manufactured in accordance with the approved internal procedures and is in compliance with the cGMP requirements. Follow up information received from the quality assurance department on 11 Apr 2013: updated batch review report.
Age: 71.0
Sex: M
Vaccine: FLU3, FLU3
Symptoms: Cellulitis, Injection site cellulitis, Injection site erythema, Injection site pain, Pain
Clinical narrative: Case number PHHY2013US020790, is an initial spontaneous report received from the Vaccine Adverse Event Reporting System (VAERS reference number: 480111) website on 04 Mar 2013 and a follow up report from the quality assurance department received on 11 Apr 2013. This was also a quality complaint report (QA reference number: 214024). This report refers to a 71-year-old male patient. His medical history was not reported and concomitant medication included ASA. He was vaccinated with FLUVIRIN (batch number: 1205121) in the left arm on 06 Dec 2012. On 08 Dec 2012 (48 hours after vaccination), he experienced some itching, soreness and then had gradual redness and soreness at the site of vaccination. He also experienced cellulitis on the entire left upper/lower arm below the injection site. It was reported that the "swelling occurred up" until the visit to emergency room as of 26 Dec 2012. The outcome of the events was reported as completely recovered as of 26 Dec 2012. The causality and seriousness of the event were not reported. Batch review report from the QA reference number 214024 was received from the quality assurance department on 11 Apr 2013. Based on the document review, it was stated that the concerned FLUVIRIN batch number 1205121 was manufactured in accordance with approved internal procedures and it was in compliance with the current good manufacturing practices (cGMP) requirements. Follow up report from the QA department received on 11 Apr 2013: The QA reference number and the QA investigation report were added.
Age: 71.0
Sex: M
Vaccine: FLU3, FLU3
Symptoms: Pruritus, Swelling
Clinical narrative: Case number PHHY2013US020790, is an initial spontaneous report received from the Vaccine Adverse Event Reporting System (VAERS reference number: 480111) website on 04 Mar 2013 and a follow up report from the quality assurance department received on 11 Apr 2013. This was also a quality complaint report (QA reference number: 214024). This report refers to a 71-year-old male patient. His medical history was not reported and concomitant medication included ASA. He was vaccinated with FLUVIRIN (batch number: 1205121) in the left arm on 06 Dec 2012. On 08 Dec 2012 (48 hours after vaccination), he experienced some itching, soreness and then had gradual redness and soreness at the site of vaccination. He also experienced cellulitis on the entire left upper/lower arm below the injection site. It was reported that the "swelling occurred up" until the visit to emergency room as of 26 Dec 2012. The outcome of the events was reported as completely recovered as of 26 Dec 2012. The causality and seriousness of the event were not reported. Batch review report from the QA reference number 214024 was received from the quality assurance department on 11 Apr 2013. Based on the document review, it was stated that the concerned FLUVIRIN batch number 1205121 was manufactured in accordance with approved internal procedures and it was in compliance with the current good manufacturing practices (cGMP) requirements. Follow up report from the QA department received on 11 Apr 2013: The QA reference number and the QA investigation report were added.
Age: 71.0
Sex: M
Vaccine: FLU3, FLU3
Symptoms: Cellulitis, Injection site cellulitis, Injection site erythema, Injection site pruritus, Vaccination site pain
Clinical narrative: Case number PHHY2013US020790, is an initial spontaneous report received from the Vaccine Adverse Event Reporting System (VAERS reference number: 480111) website on 04 Mar 2013 and a follow up report from the quality assurance department received on 11 Apr 2013. This was also a quality complaint report (QA reference number: 214024). This report refers to a 71-year-old male patient. His medical history was not reported and concomitant medication included ASA. He was vaccinated with FLUVIRIN (batch number: 1205121) in the left arm on 06 Dec 2012. On 08 Dec 2012 (48 hours after vaccination), he experienced some itching, soreness and then had gradual redness and soreness at the site of vaccination. He also experienced cellulitis on the entire left upper/lower arm below the injection site. It was reported that the "swelling occurred up" until the visit to emergency room as of 26 Dec 2012. The outcome of the events was reported as completely recovered as of 26 Dec 2012. The causality and seriousness of the event were not reported. Batch review report from the QA reference number 214024 was received from the quality assurance department on 11 Apr 2013. Based on the document review, it was stated that the concerned FLUVIRIN batch number 1205121 was manufactured in accordance with approved internal procedures and it was in compliance with the current good manufacturing practices (cGMP) requirements. Follow up report from the QA department received on 11 Apr 2013: The QA reference number and the QA investigation report were added.
Age: 43.0
Sex: F
Vaccine: FLU3, FLU3, FLU3
Symptoms: Biopsy skin abnormal, Extranodal marginal zone B-cell lymphoma (MALT type), Injection site erythema, Injection site nodule, Positron emission tomogram abnormal
Clinical narrative: Case number PHHY2013US032487, is an initial spontaneous report received from the Vaccine Adverse Event Reporting System (VAERS reference number: 480795) website on 04 Apr 2013 with a follow-up received on 08 Apr 2013. This report refers to a 43-year-old male patient. His medical history and concomitant medication were not reported. He was vaccinated with FLUVIRIN (batch number: unknown) intramuscularly into left arm on 03 Nov 2011. On the same day, he developed lump at the site of injection and it turned to red. He did not bother much about the reactions, but the reactions remain unchanged, even though several months were passed away. He visited a dermatologist to get his spot removed and he was suggested to have biopsy. The result of biopsy was little strange and he was sent to an oncologist. Oncologist ordered a PET (positron emission tomography) Scan and then scheduled a surgery to remove the "tumor" (tumour excision). He was diagnosed with "extranodal marginal zone lymphoma of mucosa-associated lymphoid tissue, extending to the surgical margins" on 12 Dec 2012. He had been taking radiation therapy for two weeks and had six more appointments remaining. The outcome of the events was reported as not recovered as of 09 Jan 2013. The case was assessed as life threatening by the reporter. The causality of the events was not reported. The QA department commented that they were not able to record the indicated batch number in sentry. Therefore without a correct batch number available the case would be recorded or investigated. Hence, the batch number reported in VAERS document was deleted from the case as QA department confirmed that it was a not a Novartis batch number. Follow-up received from the quality assurance department on 08 Apr 2013: Updated information about batch number.
Age: 43.0
Sex: F
Vaccine: FLU3, FLU3, FLU3
Symptoms: Tumour excision
Clinical narrative: Case number PHHY2013US032487, is an initial spontaneous report received from the Vaccine Adverse Event Reporting System (VAERS reference number: 480795) website on 04 Apr 2013 with a follow-up received on 08 Apr 2013. This report refers to a 43-year-old male patient. His medical history and concomitant medication were not reported. He was vaccinated with FLUVIRIN (batch number: unknown) intramuscularly into left arm on 03 Nov 2011. On the same day, he developed lump at the site of injection and it turned to red. He did not bother much about the reactions, but the reactions remain unchanged, even though several months were passed away. He visited a dermatologist to get his spot removed and he was suggested to have biopsy. The result of biopsy was little strange and he was sent to an oncologist. Oncologist ordered a PET (positron emission tomography) Scan and then scheduled a surgery to remove the "tumor" (tumour excision). He was diagnosed with "extranodal marginal zone lymphoma of mucosa-associated lymphoid tissue, extending to the surgical margins" on 12 Dec 2012. He had been taking radiation therapy for two weeks and had six more appointments remaining. The outcome of the events was reported as not recovered as of 09 Jan 2013. The case was assessed as life threatening by the reporter. The causality of the events was not reported. The QA department commented that they were not able to record the indicated batch number in sentry. Therefore without a correct batch number available the case would be recorded or investigated. Hence, the batch number reported in VAERS document was deleted from the case as QA department confirmed that it was a not a Novartis batch number. Follow-up received from the quality assurance department on 08 Apr 2013: Updated information about batch number.
Age: 43.0
Sex: F
Vaccine: FLU3, FLU3, FLU3
Symptoms: Biopsy skin abnormal, Extranodal marginal zone B-cell lymphoma (MALT type), Injection site erythema, Injection site mass, Positron emission tomogram abnormal
Clinical narrative: Case number PHHY2013US032487, is an initial spontaneous report received from the Vaccine Adverse Event Reporting System (VAERS reference number: 480795) website on 04 Apr 2013 with a follow-up received on 08 Apr 2013. This report refers to a 43-year-old male patient. His medical history and concomitant medication were not reported. He was vaccinated with FLUVIRIN (batch number: unknown) intramuscularly into left arm on 03 Nov 2011. On the same day, he developed lump at the site of injection and it turned to red. He did not bother much about the reactions, but the reactions remain unchanged, even though several months were passed away. He visited a dermatologist to get his spot removed and he was suggested to have biopsy. The result of biopsy was little strange and he was sent to an oncologist. Oncologist ordered a PET (positron emission tomography) Scan and then scheduled a surgery to remove the "tumor" (tumour excision). He was diagnosed with "extranodal marginal zone lymphoma of mucosa-associated lymphoid tissue, extending to the surgical margins" on 12 Dec 2012. He had been taking radiation therapy for two weeks and had six more appointments remaining. The outcome of the events was reported as not recovered as of 09 Jan 2013. The case was assessed as life threatening by the reporter. The causality of the events was not reported. The QA department commented that they were not able to record the indicated batch number in sentry. Therefore without a correct batch number available the case would be recorded or investigated. Hence, the batch number reported in VAERS document was deleted from the case as QA department confirmed that it was a not a Novartis batch number. Follow-up received from the quality assurance department on 08 Apr 2013: Updated information about batch number.
Age: 43.0
Sex: F
Vaccine: FLU3, FLU3, FLU3
Symptoms: B-cell lymphoma, Biopsy, Biopsy lymph gland abnormal, Flow cytometry, Injection site erythema
Clinical narrative: Case number PHHY2013US032487, is an initial spontaneous report received from the Vaccine Adverse Event Reporting System (VAERS reference number: 480795) website on 04 Apr 2013 with a follow-up received on 08 Apr 2013. This report refers to a 43-year-old male patient. His medical history and concomitant medication were not reported. He was vaccinated with FLUVIRIN (batch number: unknown) intramuscularly into left arm on 03 Nov 2011. On the same day, he developed lump at the site of injection and it turned to red. He did not bother much about the reactions, but the reactions remain unchanged, even though several months were passed away. He visited a dermatologist to get his spot removed and he was suggested to have biopsy. The result of biopsy was little strange and he was sent to an oncologist. Oncologist ordered a PET (positron emission tomography) Scan and then scheduled a surgery to remove the "tumor" (tumour excision). He was diagnosed with "extranodal marginal zone lymphoma of mucosa-associated lymphoid tissue, extending to the surgical margins" on 12 Dec 2012. He had been taking radiation therapy for two weeks and had six more appointments remaining. The outcome of the events was reported as not recovered as of 09 Jan 2013. The case was assessed as life threatening by the reporter. The causality of the events was not reported. The QA department commented that they were not able to record the indicated batch number in sentry. Therefore without a correct batch number available the case would be recorded or investigated. Hence, the batch number reported in VAERS document was deleted from the case as QA department confirmed that it was a not a Novartis batch number. Follow-up received from the quality assurance department on 08 Apr 2013: Updated information about batch number.
Age: 43.0
Sex: F
Vaccine: FLU3, FLU3, FLU3
Symptoms: Injection site swelling, Lesion excision, Positron emission tomogram
Clinical narrative: Case number PHHY2013US032487, is an initial spontaneous report received from the Vaccine Adverse Event Reporting System (VAERS reference number: 480795) website on 04 Apr 2013 with a follow-up received on 08 Apr 2013. This report refers to a 43-year-old male patient. His medical history and concomitant medication were not reported. He was vaccinated with FLUVIRIN (batch number: unknown) intramuscularly into left arm on 03 Nov 2011. On the same day, he developed lump at the site of injection and it turned to red. He did not bother much about the reactions, but the reactions remain unchanged, even though several months were passed away. He visited a dermatologist to get his spot removed and he was suggested to have biopsy. The result of biopsy was little strange and he was sent to an oncologist. Oncologist ordered a PET (positron emission tomography) Scan and then scheduled a surgery to remove the "tumor" (tumour excision). He was diagnosed with "extranodal marginal zone lymphoma of mucosa-associated lymphoid tissue, extending to the surgical margins" on 12 Dec 2012. He had been taking radiation therapy for two weeks and had six more appointments remaining. The outcome of the events was reported as not recovered as of 09 Jan 2013. The case was assessed as life threatening by the reporter. The causality of the events was not reported. The QA department commented that they were not able to record the indicated batch number in sentry. Therefore without a correct batch number available the case would be recorded or investigated. Hence, the batch number reported in VAERS document was deleted from the case as QA department confirmed that it was a not a Novartis batch number. Follow-up received from the quality assurance department on 08 Apr 2013: Updated information about batch number.
Age: 37.0
Sex: M
Vaccine: FLU3, FLU3
Symptoms: Activities of daily living impaired, Arthralgia, Chills, Dehydration, Diarrhoea
Clinical narrative: Case number PHHY2013US032454 is an initial spontaneous report received from the Vaccine Adverse Event Reporting System (VAERS reference number: 480905) website on 04 Apr 2013 with a follow-up received on 10 Apr 2013. This report refers to a 37-year-old male patient. He was vaccinated with FLUVIRIN (batch number: unknown) on 05 Jan 2013 intramuscularly to the left arm. On 06 Jan 2013, one day after vaccination, he experienced complete explosive liquid diarrhea for a duration of day and half. He also experienced chills, joint aches and was lightheaded as he became dehydrated. On the same date, at the night, he started intravenous 0.9% normal saline on self to rehydrate. He also took KAOPECTATE as treatment and he was out of work for one day. The outcome of the events was reported recovered as of 10 Jan 2013. The seriousness and causality of the events were not reported. QA department commented that the provided batch number does not belong to Novartis and they would not proceed with investigation. Therefore, the batch number reported in VAERS document was deleted from the case. Follow-up received from the quality assurance department on 10 Apr 2013: Updated comment from QA.
Age: 37.0
Sex: M
Vaccine: FLU3, FLU3
Symptoms: Dizziness
Clinical narrative: Case number PHHY2013US032454 is an initial spontaneous report received from the Vaccine Adverse Event Reporting System (VAERS reference number: 480905) website on 04 Apr 2013 with a follow-up received on 10 Apr 2013. This report refers to a 37-year-old male patient. He was vaccinated with FLUVIRIN (batch number: unknown) on 05 Jan 2013 intramuscularly to the left arm. On 06 Jan 2013, one day after vaccination, he experienced complete explosive liquid diarrhea for a duration of day and half. He also experienced chills, joint aches and was lightheaded as he became dehydrated. On the same date, at the night, he started intravenous 0.9% normal saline on self to rehydrate. He also took KAOPECTATE as treatment and he was out of work for one day. The outcome of the events was reported recovered as of 10 Jan 2013. The seriousness and causality of the events were not reported. QA department commented that the provided batch number does not belong to Novartis and they would not proceed with investigation. Therefore, the batch number reported in VAERS document was deleted from the case. Follow-up received from the quality assurance department on 10 Apr 2013: Updated comment from QA.
Age: 40.0
Sex: F
Vaccine: MMR, MMR
Symptoms: Arthralgia, Generalised erythema, Influenza like illness
Clinical narrative: This spontaneous report as received from a registered nurse refers to a 40 year old female patient with no drug reactions or allergies. On 28-MAR-2013, the patient was vaccinated with a 0.5 ml dose of M-M-R II (Lot # 0008AE, expiration date 16-DEC-2013) subcutaneously. The nurse reported that on 02-APR-2013, the patient experienced achy in the joints, had a fever, and was in bed for 3 days. On 07-APR-2013, the patient experienced a measles rash on the trunk and extremities, everywhere but the face. The nurse was told by the patient the rash had faded a lot on 08-APR-2013, but it was bright on 07-APR-2013 and the patient was feeling better. The patient did not receive treatment for the adverse events. There were no lab diagnosis or studies performed. The outcome of was in bed for 3 days, fever, achy in the joints and measles rash on the trunk and extremities was reported as recovering/resolving. The patient sought medical attention by a phone call. Additional information has been requested.
Age: 40.0
Sex: F
Vaccine: MMR, MMR
Symptoms: Arthralgia, Measles, Mobility decreased, Pyrexia
Clinical narrative: This spontaneous report as received from a registered nurse refers to a 40 year old female patient with no drug reactions or allergies. On 28-MAR-2013, the patient was vaccinated with a 0.5 ml dose of M-M-R II (Lot # 0008AE, expiration date 16-DEC-2013) subcutaneously. The nurse reported that on 02-APR-2013, the patient experienced achy in the joints, had a fever, and was in bed for 3 days. On 07-APR-2013, the patient experienced a measles rash on the trunk and extremities, everywhere but the face. The nurse was told by the patient the rash had faded a lot on 08-APR-2013, but it was bright on 07-APR-2013 and the patient was feeling better. The patient did not receive treatment for the adverse events. There were no lab diagnosis or studies performed. The outcome of was in bed for 3 days, fever, achy in the joints and measles rash on the trunk and extremities was reported as recovering/resolving. The patient sought medical attention by a phone call. Additional information has been requested.
Age: 5.0
Sex: F
Vaccine: DTPIPV, MMR, VARZOS, DTAPIPV, MMR, VARZOS
Symptoms: Wrong drug administered
Clinical narrative: This spontaneous report as received from a physician refers to a 5 year old female patient. On 09-APR-2013 the patient was vaccinated with a dose of ZOSTAVAX (lot # not reported), 0.65 mL, subcutaneously. The reporter stated that the patient inadvertently received dose of ZOSTAVAX instead of (Merck) VARIVAX. No adverse effects reported. Additional information has been requested.
Age: 5.0
Sex: F
Vaccine: DTPIPV, MMR, VARZOS, DTAPIPV, MMR, VARZOS
Symptoms: No adverse event, Wrong drug administered
Clinical narrative: This spontaneous report as received from a physician refers to a 5 year old female patient. On 09-APR-2013 the patient was vaccinated with a dose of ZOSTAVAX (lot # not reported), 0.65 mL, subcutaneously. The reporter stated that the patient inadvertently received dose of ZOSTAVAX instead of (Merck) VARIVAX. No adverse effects reported. Additional information has been requested.
Age: 67.0
Sex: F
Vaccine: PPV
Symptoms: Injection site swelling
Clinical narrative: Severe swelling surrounding injection site on left tricep.
Age: 22.0
Sex: F
Vaccine: HPV4, HPV4
Symptoms: Cervicectomy, Cervix carcinoma, Colposcopy abnormal, Laboratory test abnormal, Loop electrosurgical excision procedure
Clinical narrative: This spontaneous report as received from a physician refers to a 22 year old female patient. The patient was no pregnant. The patient developed cervical cancer after the patient mentioned she previously received 3 doses of GARDASIL (injection, 120Y). The physician said he only saw this patient in his office on 2 occasions and the patient told him that she received 3 doses of GARDASIL on unspecified dates when she was 16 years of age, prior to sexual activity. The physician stated the patient tested positive for "a high grade lesion type 16, and the patient has cervical cancer". The physician said the patient had her entire cervix removed and the cancer has progressed into the patient's lymph nodes. Lab diagnostics included type testing on lesions. Colposcopy, loop electrosurgical excision procedure (LEEP) procedure. The patient sought medical attention through office visit. The patient was not recovered from the AE. Upon internal review, cervical cancer and the cancer has progressed into the patient's lymph nodes were considered to be an other medically significant event. Additional information has been requested.
Age: 22.0
Sex: F
Vaccine: HPV4, HPV4
Symptoms: Metastases to lymph nodes
Clinical narrative: This spontaneous report as received from a physician refers to a 22 year old female patient. The patient was no pregnant. The patient developed cervical cancer after the patient mentioned she previously received 3 doses of GARDASIL (injection, 120Y). The physician said he only saw this patient in his office on 2 occasions and the patient told him that she received 3 doses of GARDASIL on unspecified dates when she was 16 years of age, prior to sexual activity. The physician stated the patient tested positive for "a high grade lesion type 16, and the patient has cervical cancer". The physician said the patient had her entire cervix removed and the cancer has progressed into the patient's lymph nodes. Lab diagnostics included type testing on lesions. Colposcopy, loop electrosurgical excision procedure (LEEP) procedure. The patient sought medical attention through office visit. The patient was not recovered from the AE. Upon internal review, cervical cancer and the cancer has progressed into the patient's lymph nodes were considered to be an other medically significant event. Additional information has been requested.
Age: 22.0
Sex: F
Vaccine: HPV4, HPV4
Symptoms: Cervicectomy, Cervix carcinoma, Colposcopy, Human papilloma virus test positive, Loop electrosurgical excision procedure
Clinical narrative: This spontaneous report as received from a physician refers to a 22 year old female patient. The patient was no pregnant. The patient developed cervical cancer after the patient mentioned she previously received 3 doses of GARDASIL (injection, 120Y). The physician said he only saw this patient in his office on 2 occasions and the patient told him that she received 3 doses of GARDASIL on unspecified dates when she was 16 years of age, prior to sexual activity. The physician stated the patient tested positive for "a high grade lesion type 16, and the patient has cervical cancer". The physician said the patient had her entire cervix removed and the cancer has progressed into the patient's lymph nodes. Lab diagnostics included type testing on lesions. Colposcopy, loop electrosurgical excision procedure (LEEP) procedure. The patient sought medical attention through office visit. The patient was not recovered from the AE. Upon internal review, cervical cancer and the cancer has progressed into the patient's lymph nodes were considered to be an other medically significant event. Additional information has been requested.
Age: 22.0
Sex: F
Vaccine: HPV4, HPV4
Symptoms: Cervicectomy, Cervix carcinoma, Colposcopy abnormal, Laboratory test abnormal, Loop electrosurgical excision procedure
Clinical narrative: This spontaneous report as received from a physician refers to a 22 year old female patient. The patient was no pregnant. The patient developed cervical cancer after the patient mentioned she previously received 3 doses of GARDASIL (injection, 120Y). The physician said he only saw this patient in his office on 2 occasions and the patient told him that she received 3 doses of GARDASIL on unspecified dates when she was 16 years of age, prior to sexual activity. The physician stated the patient tested positive for "a high grade lesion type 16, and the patient has cervical cancer". The physician said the patient had her entire cervix removed and the cancer has progressed into the patient's lymph nodes. Lab diagnostics included type testing on lesions, Colposcopy, loop electrosurgical excision procedure (LEEP) procedure. The patient sought medical attention through office visit. The patient was not recovered from the AE. Upon internal review, cervical cancer and the cancer has progressed into the patient's lymph nodes were considered to be an other medically significant event. Additional information has been requested.
Age: 22.0
Sex: F
Vaccine: HPV4, HPV4
Symptoms: Metastases to lymph nodes
Clinical narrative: This spontaneous report as received from a physician refers to a 22 year old female patient. The patient was no pregnant. The patient developed cervical cancer after the patient mentioned she previously received 3 doses of GARDASIL (injection, 120Y). The physician said he only saw this patient in his office on 2 occasions and the patient told him that she received 3 doses of GARDASIL on unspecified dates when she was 16 years of age, prior to sexual activity. The physician stated the patient tested positive for "a high grade lesion type 16, and the patient has cervical cancer". The physician said the patient had her entire cervix removed and the cancer has progressed into the patient's lymph nodes. Lab diagnostics included type testing on lesions, Colposcopy, loop electrosurgical excision procedure (LEEP) procedure. The patient sought medical attention through office visit. The patient was not recovered from the AE. Upon internal review, cervical cancer and the cancer has progressed into the patient's lymph nodes were considered to be an other medically significant event. Additional information has been requested.
Age: 22.0
Sex: F
Vaccine: HPV4, HPV4
Symptoms: Cervicectomy, Cervix carcinoma, Colposcopy, Human papilloma virus test positive, Loop electrosurgical excision procedure
Clinical narrative: This spontaneous report as received from a physician refers to a 22 year old female patient. The patient was no pregnant. The patient developed cervical cancer after the patient mentioned she previously received 3 doses of GARDASIL (injection, 120Y). The physician said he only saw this patient in his office on 2 occasions and the patient told him that she received 3 doses of GARDASIL on unspecified dates when she was 16 years of age, prior to sexual activity. The physician stated the patient tested positive for "a high grade lesion type 16, and the patient has cervical cancer". The physician said the patient had her entire cervix removed and the cancer has progressed into the patient's lymph nodes. Lab diagnostics included type testing on lesions, Colposcopy, loop electrosurgical excision procedure (LEEP) procedure. The patient sought medical attention through office visit. The patient was not recovered from the AE. Upon internal review, cervical cancer and the cancer has progressed into the patient's lymph nodes were considered to be an other medically significant event. Additional information has been requested.
Age: 0.2
Sex: U
Vaccine: HPV4
Symptoms: Death, Foetal exposure during pregnancy, Toxicologic test
Clinical narrative: Information has been received from a mother for GARDASIL, a Pregnancy Registry product, concerning her 8 week old baby. On an unknown date in December 2011 the mother was vaccinated with the first dose of GARDASIL (lot number 0626AA) (dose, route and injection site were not reported). On 28-FEB-2012, the mother was vaccinated with the second dose of GARDASIL (lot number, dose, route and injection site were not reported). On 23-MAR-2012 the mother found she was pregnant and on 26-NOV-2012 she delivered the infant. The baby was born on 26-NOV-2012, and died on 25-JAN-2013. Toxicology tests are being run to see the cause of death. The action taken and causality of death was not provided. The mother's information was captured in MARRS # 1304USA006478 (Parent-Child Link). Additional information is not expected.
Age: 71.0
Sex: M
Vaccine: VARZOS
Symptoms: Electroencephalogram normal, Grand mal convulsion, Nuclear magnetic resonance imaging brain abnormal, Petit mal epilepsy
Clinical narrative: Grand mal seizure x 1. Petit mal seizure x 2. Received ZOSTAVAX 12-17-12. Above seizures 12-31-12. No prior h/o seizure.
Age: 77.0
Sex: F
Vaccine: PPV
Symptoms: Bradycardia, Electrocardiogram abnormal, Loss of consciousness
Clinical narrative: About 15 min after given vaccine pt passed out, providers notified we laid her down. Put her on 2 liters of O2 she started coming out of it. Rescue was called. Vitals obtained EKG done. Bradycardia with pulse of 44. Transported to ER.
Age: 60.0
Sex: M
Vaccine: VARZOS
Symptoms: Injection site rash, Injection site swelling
Clinical narrative: Patient received ZOSTAVAX vaccination on 4/4/2013 and on 4/11/2013 patient called and stated that "he had rash and swollen at injection site". Patient was told to see doctor for further evaluation.
Age: 72.0
Sex: F
Vaccine: PPV
Symptoms: Blood test, Rheumatoid arthritis
Clinical narrative: Autoimmune reaction to PNEUMOVAX 23 resulting in rheumatoid arthritis. I have been informed this is not curable and I will be on medications for the remainder of my life. On 10-24-12 I was given ZOSTAVAX.
Sex: U
Vaccine: MNQ
Symptoms: Encephalitis
Clinical narrative: Case number PHEH2013US008149 is an initial spontaneous report received from a physician on 08 Apr 2013. This report refers to a patient whose identifiers were not reported. The patient's medical history and concomitant medications were not reported. The patient was vaccinated with meningococcal vaccine (manufacturer and batch number: not reported, hence conservatively coded as MENVEO INN) on an unknown date. On an unspecified date, the patient developed encephalitis. The outcome of the event was not reported. The physician reported that the causality of encephalitis was temporally associated to meningitis vaccination.
Age: 41.0
Sex: M
Vaccine: ANTH
Symptoms: Arthralgia, Muscle rigidity, Muscle swelling, Myalgia
Clinical narrative: Muscle aches localized to arm and joints that persisted past three weeks. Muscle rigidity noted by health care provider at 3 weeks and it is noted to be more swelling and rigidity than normal.
Age: 71.0
Sex: F
Vaccine: FLU3
Symptoms: Balance disorder, Blood pressure abnormal, Blood test normal, Cardiac monitoring normal, Electrocardiogram normal
Clinical narrative: Pain in shoulder joint 4 mos. Fainted 3 days later 1st ever! Developed tremors, loss of balance, hard to walk, blood pressure jumped for 3 mos; injection felt like it went in bone, couldn't lay on left side for 4 mos.
Age: 71.0
Sex: F
Vaccine: FLU3
Symptoms: Gait disturbance, Musculoskeletal pain, Nuclear magnetic resonance imaging normal, Syncope, Tremor
Clinical narrative: Pain in shoulder joint 4 mos. Fainted 3 days later 1st ever! Developed tremors, loss of balance, hard to walk, blood pressure jumped for 3 mos; injection felt like it went in bone, couldn't lay on left side for 4 mos.
Age: 55.0
Sex: F
Vaccine: FLU3, PPV
Symptoms: Central nervous system lesion, Hypoaesthesia, Injected limb mobility decreased, Injection site pain, Nuclear magnetic resonance imaging abnormal
Clinical narrative: Severe pain at time of shot, arm would not move for weeks. Went to physician- family gave pain meds. I have throbbing and numbness in both arms. Neurologist found lesions in brain and spinal fluid. Can't figure out. Getting 2nd opinion.
Age: 55.0
Sex: F
Vaccine: FLU3, PPV
Symptoms: Nuclear magnetic resonance imaging brain abnormal, Pain, Pain in extremity
Clinical narrative: Severe pain at time of shot, arm would not move for weeks. Went to physician- family gave pain meds. I have throbbing and numbness in both arms. Neurologist found lesions in brain and spinal fluid. Can't figure out. Getting 2nd opinion.
Age: 1.57
Sex: F
Vaccine: DTAP, HIBV, IPV, PNC13
Symptoms: Encephalitis, Pyrexia, Sinusitis, Viral infection, Vomiting
Clinical narrative: According to physician ER reports patient received immunizations on 3/5/13 at app. 11:00 AM. That evening she apparently had a low grade fever that responded to TYLENOL. She subsequently had an uneventful 48 hour period. She was seen in the ER on 3/9/13 at 10:00 for vomiting and fever. Was d/c home in "good" condition after receiving ZOFRAN. She was seen again in ER at 22:47 that day for "persistent" vomiting and was transferred to the main hospital where she was eventually diagnosed with "meningoencephalitis, most likely viral etiology" and "sinusitis". Discharged home in good condition on March 20, 2013.
Age: 11.0
Sex: M
Vaccine: MNQ, TDAP
Symptoms: Immediate post-injection reaction, Loss of consciousness, Muscle rigidity, Pallor
Clinical narrative: 2:15 pm Tdap given 1st in (L) arm. Then MENVEO in (R) arm. Immediately after giving MENVEO, the child became rigid, stiffened up, LOC for 3 seconds. Had the child lay down for 15 mins, V/S P.66, RR 20 BP 100/56 O2 sat 97% RA; Child's color came back, after 30 min was able to go home.
Age: 1.04
Sex: M
Vaccine: FLU3, HIBV, PNC13, VARCEL
Symptoms: Herpes zoster, Rash
Clinical narrative: Baby was given varicella vaccine and was seen in office on 04-08-13 for a rash diagnosed by two M.D.'s as shingles (herpes zoster).
Age: 71.0
Sex: F
Vaccine: FLU3
Symptoms: Angiogram normal, Arthralgia, Asthenia, Biopsy artery normal, Blood test normal
Clinical narrative: Within several hours after receiving vaccine pt felt like she "was hit by truck". Seen 3 wks later due to persistent myalgia, weakness, wt gain. Labs ordered, referred to rheumatologist, seen 2 wks later, dx'ed with polymyalgia rheumatica. Symptoms were: severe joint pain in hips, knees, shoulders & generalized widespread muscle pain. Sed rate and C-reactive protein blood tests were both elevated, indicating an inflammatory reaction. Patient was started on Prednisone, requiring a dose of 60 mg to control symptoms. Pt was referred to the rheumatology clinic. It was a concern that the pt. might also have Giant Cell Temporal Arteritis. So she was referred to a surgeon who performed a (R) temporal artery biopsy. This was negative. Pt. started a slow taper of the prednisone, reaching a dose of 17.5 mg on Feb. 8, 2013. Symptoms returned then and blood tests again were elevated. Dosage of prednisone was again increased and it was also decided to add methotrexate. Pt has complained of headaches and jaw pain, as well as some vision changes. Again it was a concern that the pt may have temporal arteritis, and she was hospitalized 03-28-13 to 03-30-13 for further testing. CTA of entire vascular system was negative. Blood work was stable. Discharged on Prednisone 60 mg qd and methotrexate 12.5 mg/weekly. Follow up at rheumatology on 04-18-13.
Age: 71.0
Sex: F
Vaccine: FLU3
Symptoms: C-reactive protein increased, Headache, Inflammation, Myalgia, Pain in jaw
Clinical narrative: Within several hours after receiving vaccine pt felt like she "was hit by truck". Seen 3 wks later due to persistent myalgia, weakness, wt gain. Labs ordered, referred to rheumatologist, seen 2 wks later, dx'ed with polymyalgia rheumatica. Symptoms were: severe joint pain in hips, knees, shoulders & generalized widespread muscle pain. Sed rate and C-reactive protein blood tests were both elevated, indicating an inflammatory reaction. Patient was started on Prednisone, requiring a dose of 60 mg to control symptoms. Pt was referred to the rheumatology clinic. It was a concern that the pt. might also have Giant Cell Temporal Arteritis. So she was referred to a surgeon who performed a (R) temporal artery biopsy. This was negative. Pt. started a slow taper of the prednisone, reaching a dose of 17.5 mg on Feb. 8, 2013. Symptoms returned then and blood tests again were elevated. Dosage of prednisone was again increased and it was also decided to add methotrexate. Pt has complained of headaches and jaw pain, as well as some vision changes. Again it was a concern that the pt may have temporal arteritis, and she was hospitalized 03-28-13 to 03-30-13 for further testing. CTA of entire vascular system was negative. Blood work was stable. Discharged on Prednisone 60 mg qd and methotrexate 12.5 mg/weekly. Follow up at rheumatology on 04-18-13.
Age: 71.0
Sex: F
Vaccine: FLU3
Symptoms: Polymyalgia rheumatica, Red blood cell sedimentation rate increased, Visual impairment, Weight increased
Clinical narrative: Within several hours after receiving vaccine pt felt like she "was hit by truck". Seen 3 wks later due to persistent myalgia, weakness, wt gain. Labs ordered, referred to rheumatologist, seen 2 wks later, dx'ed with polymyalgia rheumatica. Symptoms were: severe joint pain in hips, knees, shoulders & generalized widespread muscle pain. Sed rate and C-reactive protein blood tests were both elevated, indicating an inflammatory reaction. Patient was started on Prednisone, requiring a dose of 60 mg to control symptoms. Pt was referred to the rheumatology clinic. It was a concern that the pt. might also have Giant Cell Temporal Arteritis. So she was referred to a surgeon who performed a (R) temporal artery biopsy. This was negative. Pt. started a slow taper of the prednisone, reaching a dose of 17.5 mg on Feb. 8, 2013. Symptoms returned then and blood tests again were elevated. Dosage of prednisone was again increased and it was also decided to add methotrexate. Pt has complained of headaches and jaw pain, as well as some vision changes. Again it was a concern that the pt may have temporal arteritis, and she was hospitalized 03-28-13 to 03-30-13 for further testing. CTA of entire vascular system was negative. Blood work was stable. Discharged on Prednisone 60 mg qd and methotrexate 12.5 mg/weekly. Follow up at rheumatology on 04-18-13.
Age: 54.0
Sex: F
Vaccine: TDAP
Symptoms: VIIth nerve paralysis
Clinical narrative: Tdap vaccine given 3/21/13. Bells palsy dx 3/23/13.
Age: 21.0
Sex: M
Vaccine: MNQ, PPV
Symptoms: Abscess, Cellulitis, Injection site infection
Clinical narrative: Infection of injection site (R) arm. Cellulitis and abscess - R) arm. Warm compression. Doxycycline Hyclate 100 mg 2 daily for 10 days.
Age: 24.0
Sex: F
Vaccine: PPV
Symptoms: Erythema, Skin warm, Swelling
Clinical narrative: Swollen, erythematous, warm arm approximately 3 hours after vaccine. Given prednisone.
Age: 1.0
Sex: M
Vaccine: HEPA, MMR, PNC13, VARCEL
Symptoms: Contusion, Eosinophil percentage, Fall, Monocyte percentage increased, Nasal congestion
Clinical narrative: This male subject was enrolled in a study. On 08 February 2013, he received the 1st dose of GSK PRIORIX or Merck's MMR II co-administered with GSK HAVRIX 720 JUNIOR, Merck's VARIVAX and Pfizer's PREVNAR 13. This subject received PRIORIX. On 01 March 2013, 21 days after the 1st dose of Blinded vaccine, 21 days after the 1st dose of HAVRIX 720 JUNIOR, 21 days after the 1st dose of VARIVAX, 21 days after the 1st dose of PREVNAR 13, this 12-month-old subject developed petechiae. The subject was hospitalised. The event was unresolved at time of reporting. The investigator considered that there was a reasonable possibility that the petechiae may have been caused by investigational product, HAVRIX 720 JUNIOR, VARIVAX and PREVNAR 13 and that the event was possibly due to a viral infection. Investigator Comments: Received immunizations PREVNAR, HAVRIX, MMR and VARIVAX on 08 February 13. 01 March 2013 subject presented with left otitis media and petechiae under left eye, and nonspecific viral appearing rash on trunk and extremities. OMNICEF prescribed. CBC drawn and results normal except for EOS 4.0%. On 02 April 2013, subject presented with nasal congestion for two days, fever of 100.4, petechiae on extremities and face and bruising on face following a fall. No mucosal involvement. No blood noted in urine or stools. No meningism. Subject was admitted to the hospital for further evaluation on 02 April 2013 and discharged on 03 April 2013. Awaiting records for further information. Has appointment scheduled with primary care provider on 12 April 2013. Causality is listed as related to study vaccine at this time due to the known association of thrombocytopenia with MMR vaccine. We are awaiting for a final diagnosis at the subject's visit with primary care physician on 12 April 2013.
Age: 1.0
Sex: M
Vaccine: HEPA, MMR, PNC13, VARCEL
Symptoms: Otitis media, Petechiae, Platelet count decreased, Prothrombin time normal, Pyrexia
Clinical narrative: This male subject was enrolled in a study. On 08 February 2013, he received the 1st dose of GSK PRIORIX or Merck's MMR II co-administered with GSK HAVRIX 720 JUNIOR, Merck's VARIVAX and Pfizer's PREVNAR 13. This subject received PRIORIX. On 01 March 2013, 21 days after the 1st dose of Blinded vaccine, 21 days after the 1st dose of HAVRIX 720 JUNIOR, 21 days after the 1st dose of VARIVAX, 21 days after the 1st dose of PREVNAR 13, this 12-month-old subject developed petechiae. The subject was hospitalised. The event was unresolved at time of reporting. The investigator considered that there was a reasonable possibility that the petechiae may have been caused by investigational product, HAVRIX 720 JUNIOR, VARIVAX and PREVNAR 13 and that the event was possibly due to a viral infection. Investigator Comments: Received immunizations PREVNAR, HAVRIX, MMR and VARIVAX on 08 February 13. 01 March 2013 subject presented with left otitis media and petechiae under left eye, and nonspecific viral appearing rash on trunk and extremities. OMNICEF prescribed. CBC drawn and results normal except for EOS 4.0%. On 02 April 2013, subject presented with nasal congestion for two days, fever of 100.4, petechiae on extremities and face and bruising on face following a fall. No mucosal involvement. No blood noted in urine or stools. No meningism. Subject was admitted to the hospital for further evaluation on 02 April 2013 and discharged on 03 April 2013. Awaiting records for further information. Has appointment scheduled with primary care provider on 12 April 2013. Causality is listed as related to study vaccine at this time due to the known association of thrombocytopenia with MMR vaccine. We are awaiting for a final diagnosis at the subject's visit with primary care physician on 12 April 2013.