chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Sex: U
Vaccine: VARZOS
Symptoms: Pyrexia, Rash, Vomiting
Clinical narrative: This spontaneous report was received from a nurse practitioner, via agency (Ref # 2015US011074), referring to a patient of unknown age and gender. No pertinent medical history, concurrent conditions or drug reactions/allergies were reported. On an unknown date, the patient was vaccinated with ZOSTAVAX, (dose, frequency, route of administration, lot # and expiration date were not provided). No concomitant medications were reported. On an unknown date, four days after vaccination, the patient experienced diffuse rash, fever and emesis. The outcome of diffuse rash, fever and emesis was unknown. The reporter did not assess the relationship between ZOSTAVAX and the events. No product quality complaint was involved. Additional information will be provided if available.
Sex: U
Vaccine: MMRV
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report as received from a medical assistant refers to unspecified number of patients of unknown age and gender. The patients' medical history and current conditions were not provided. On unknown dates, the patients were vaccinated with doses of improperly stored PROQUAD (Merck) (dose and route were not reported) lot # K025760 expiration date 08-JUN-2016, lot # K023862 expiration date 25-MAY-2016 and lot # L009208 expiration date 17-SEP-2016. No symptoms reported. This is one of several reports received from the same reporter. Additional information is not expected as the reporter did not wish further contact.
Age: 25.0
Sex: U
Vaccine: VARCEL
Symptoms: Expired product administered, No adverse event
Clinical narrative: This spontaneous report was received from a healthcare worker and refers to a 26 year old patient of unknown age and gender. There was no information about patient's concomitant medications, pertinent medical history, drug reactions or allergies provided. On 31-AUG-2015, the patient was vaccinated with expired dose of (Oka/Merck) VARIVAX (lot# reported as J005723, expiration date 08-MAY-2015, dose, site and route of administration were not reported). The patient had not experienced an adverse effect. Additional information has been requested.
Sex: U
Vaccine: MMR
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report was received from a licensed practical nurse and refers to an unspecified number of patients. There was no information about patients' concomitant medications, pertinent medical histories, drug reactions or allergies reported. On unspecified dates, since 14-AUG-2015, the patients were vaccinated with doses of MMR II (lot# K024824, expiration date 02-DEC-2016; lot# K024036, expiration date 26-NOV-2015, doses, site and route of administration were not reported), which were exposed to temperatures outside of the recommended range. No adverse experiences had been reported. This is one of several reports received from the same reporter. Additional information has been requested.
Sex: U
Vaccine: MMR
Symptoms: Inappropriate schedule of drug administration, No adverse event
Clinical narrative: This spontaneous report as received from a certified medical assistant refers to a patient of unknown age and gender. The patient's concurrent conditions and medical history were not reported. On 05-SEP-2015, the patient was vaccinated with (Oka/Merck) VARIVAX, the patient received MMR II (dose, route, lot# and expiration date were not reported). No adverse effects reported. Additional information had been requested.
Sex: U
Vaccine: PPV
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report as received from a registered nurse refers to unspecified number of patients of unknown age and gender. On an unknown date, the patients were vaccinated with improperly stored PNEUMOVAX 23 lot# K022886, K023328 and L007720 (dose was not reported). No adverse events were reported. This is one of several reports received from the same source. Additional information has been requested.
Age: 0.4
Sex: M
Vaccine: RV5
Symptoms: Diarrhoea, Oral administration complication, Vomiting
Clinical narrative: Information has been received from a healthcare worker referring to a 5 month and 5 day old male patient. The patient's pertinent medical history and drug allergies were not reported. On an unknown date the patient was vaccinated with the second dose of oral, ROTATEQ (lot # K019372 with expiration date of 16-JUL-2016, dose and strength unknown). There was no concomitant medication. On the same day the patient vomited immediately after the vaccine was given. Outcome of vomiting was unknown. On 26-AUG-2015 the patient began to experience severe diarrhea and sought medical attention by seeing the physician on the same day. Treatment recommendations by the physician were to keep the patient hydrated and the physician would order some unspecified diagnostic tests for the patient. No lab diagnostics studies were performed yet at the time of reporting. The outcome of diarrhea was not recovered. Additional information has been requested.
Sex: U
Vaccine: HEPA
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: Information has been received from a healthcare worker referring to an unspecified number of patients of unknown age and gender. On unknown dates since 10-AUG-2015 the patients were vaccinated with an unspecified number of improperly stored doses VAQTA (lot # K012457 with expirationd date of 04-JUN-2017, dose, strength and route unknown). No adverse effect reported. This is one of the two reports received from the same reporter. Addditional information has been requested.
Sex: U
Vaccine: PPV
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report was received from a registered nurse refers to an unspecified number of patients of unknown age. On 06-AUG-2015, the patients were vaccinated with an improperly stored dose of PNEUMOVAX 23 lot # K008410, expiry date 26-FEB-2016, K008409, expiry date 04-MAR-2015. The outcome of incorrect product storage and no adverse event is unknown. The reporter considered incorrect storage and no adverse event to be related to PNEUMOVAX 23. No adverse reaction were reported. This is one of the 4 cases received from the same reporter. Additional information has been requested.
Sex: U
Vaccine: MMRV
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report was received from a nurse referring to a unspecified number of patients of unknown age and gender. On an unknown date, the patients were vaccinated with improperly stored doses of PROQUAD (Merck) (dose and route of vaccination were not reported, lot # L005297 with expiration date : 17-AUG-2016). No adverse effects reported. This is one of several reports received from the same reporter. 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 licensed practical nurse refers to a patient of unknown age and gender. There were no concomitant medications, concurrent conditions and medical history reported. On 04-AUG-2015 the patient was vaccinated with a dose of improperly stored PROQUAD (Merck) (lot # L011079, expiration date 01-OCT-2016, dose, dose # and route not reported). There was no adverse events reported. This is one of several reports received from the same reporter. Additional information has been requested.
Sex: M
Vaccine: FLU3, FLU3
Symptoms: Anotia, Apparent death, Bone disorder, Cardiac disorder, Cardiac operation
Clinical narrative: Case number PHHY2015US082588 is an initial spontaneous report from a consumer via Vaccine Adverse Event Reporting System (VAERS ID 575377) received on 07 Jul 2015 with a follow up received from the quality assurance department on 07 Sep 2015. This report refers to a male neonate born to the parent (refer mother case PHHY2015US082581). His mother was vaccinated with FLUVIRIN (batch number: not reported) on 30 Jan 2012. He was born with a heart condition and many birth defects including cleft lip, missing ear and eardrum, scoliosis, muscle that do not work on the left side of his face, missing bone in neck and many more birth defects. He has had two heart surgeries and was due for a third. He had a feeding tube, takes medicine (not specified) twice a day for his heart. He almost died when he was born due to his heart. He was on a breathing tube for the first month of his life before his heart surgery. The outcome of the events was reported as not recovered. The events were reported as life threatening, serious (permanent disability, hospitalization (60 days)). Causality was not reported. The reported FLUVIRIN batch number 66521-114 was considered as invalid by quality assurance department and hence no QA investigation can be performed for the case. Follow up received from the quality assurance department on 07 Sep 2015: updated QA comment.
Sex: M
Vaccine: FLU3, FLU3
Symptoms: Cleft lip, Congenital anomaly, Foetal exposure during pregnancy, Gastrointestinal tube insertion, Mechanical ventilation
Clinical narrative: Case number PHHY2015US082588 is an initial spontaneous report from a consumer via Vaccine Adverse Event Reporting System (VAERS ID 575377) received on 07 Jul 2015 with a follow up received from the quality assurance department on 07 Sep 2015. This report refers to a male neonate born to the parent (refer mother case PHHY2015US082581). His mother was vaccinated with FLUVIRIN (batch number: not reported) on 30 Jan 2012. He was born with a heart condition and many birth defects including cleft lip, missing ear and eardrum, scoliosis, muscle that do not work on the left side of his face, missing bone in neck and many more birth defects. He has had two heart surgeries and was due for a third. He had a feeding tube, takes medicine (not specified) twice a day for his heart. He almost died when he was born due to his heart. He was on a breathing tube for the first month of his life before his heart surgery. The outcome of the events was reported as not recovered. The events were reported as life threatening, serious (permanent disability, hospitalization (60 days)). Causality was not reported. The reported FLUVIRIN batch number 66521-114 was considered as invalid by quality assurance department and hence no QA investigation can be performed for the case. Follow up received from the quality assurance department on 07 Sep 2015: updated QA comment.
Sex: M
Vaccine: FLU3, FLU3
Symptoms: Muscle disorder, Scoliosis
Clinical narrative: Case number PHHY2015US082588 is an initial spontaneous report from a consumer via Vaccine Adverse Event Reporting System (VAERS ID 575377) received on 07 Jul 2015 with a follow up received from the quality assurance department on 07 Sep 2015. This report refers to a male neonate born to the parent (refer mother case PHHY2015US082581). His mother was vaccinated with FLUVIRIN (batch number: not reported) on 30 Jan 2012. He was born with a heart condition and many birth defects including cleft lip, missing ear and eardrum, scoliosis, muscle that do not work on the left side of his face, missing bone in neck and many more birth defects. He has had two heart surgeries and was due for a third. He had a feeding tube, takes medicine (not specified) twice a day for his heart. He almost died when he was born due to his heart. He was on a breathing tube for the first month of his life before his heart surgery. The outcome of the events was reported as not recovered. The events were reported as life threatening, serious (permanent disability, hospitalization (60 days)). Causality was not reported. The reported FLUVIRIN batch number 66521-114 was considered as invalid by quality assurance department and hence no QA investigation can be performed for the case. Follow up received from the quality assurance department on 07 Sep 2015: updated QA comment.
Sex: M
Vaccine: FLU3, FLU3
Symptoms: Anomaly of middle ear congenital, Anotia, Apparent life threatening event, Bone disorder, Cardiac disorder
Clinical narrative: Case number PHHY2015US082588 is an initial spontaneous report from a consumer via Vaccine Adverse Event Reporting System (VAERS ID 575377) received on 07 Jul 2015 with a follow up received from the quality assurance department on 07 Sep 2015. This report refers to a male neonate born to the parent (refer mother case PHHY2015US082581). His mother was vaccinated with FLUVIRIN (batch number: not reported) on 30 Jan 2012. He was born with a heart condition and many birth defects including cleft lip, missing ear and eardrum, scoliosis, muscle that do not work on the left side of his face, missing bone in neck and many more birth defects. He has had two heart surgeries and was due for a third. He had a feeding tube, takes medicine (not specified) twice a day for his heart. He almost died when he was born due to his heart. He was on a breathing tube for the first month of his life before his heart surgery. The outcome of the events was reported as not recovered. The events were reported as life threatening, serious (permanent disability, hospitalization (60 days)). Causality was not reported. The reported FLUVIRIN batch number 66521-114 was considered as invalid by quality assurance department and hence no QA investigation can be performed for the case. Follow up received from the quality assurance department on 07 Sep 2015: updated QA comment.
Sex: M
Vaccine: FLU3, FLU3
Symptoms: Cardiac operation, Cleft lip, Congenital anomaly, Foetal exposure during pregnancy, Gastrointestinal tube insertion
Clinical narrative: Case number PHHY2015US082588 is an initial spontaneous report from a consumer via Vaccine Adverse Event Reporting System (VAERS ID 575377) received on 07 Jul 2015 with a follow up received from the quality assurance department on 07 Sep 2015. This report refers to a male neonate born to the parent (refer mother case PHHY2015US082581). His mother was vaccinated with FLUVIRIN (batch number: not reported) on 30 Jan 2012. He was born with a heart condition and many birth defects including cleft lip, missing ear and eardrum, scoliosis, muscle that do not work on the left side of his face, missing bone in neck and many more birth defects. He has had two heart surgeries and was due for a third. He had a feeding tube, takes medicine (not specified) twice a day for his heart. He almost died when he was born due to his heart. He was on a breathing tube for the first month of his life before his heart surgery. The outcome of the events was reported as not recovered. The events were reported as life threatening, serious (permanent disability, hospitalization (60 days)). Causality was not reported. The reported FLUVIRIN batch number 66521-114 was considered as invalid by quality assurance department and hence no QA investigation can be performed for the case. Follow up received from the quality assurance department on 07 Sep 2015: updated QA comment.
Sex: M
Vaccine: FLU3, FLU3
Symptoms: Mechanical ventilation, Muscle disorder, Scoliosis
Clinical narrative: Case number PHHY2015US082588 is an initial spontaneous report from a consumer via Vaccine Adverse Event Reporting System (VAERS ID 575377) received on 07 Jul 2015 with a follow up received from the quality assurance department on 07 Sep 2015. This report refers to a male neonate born to the parent (refer mother case PHHY2015US082581). His mother was vaccinated with FLUVIRIN (batch number: not reported) on 30 Jan 2012. He was born with a heart condition and many birth defects including cleft lip, missing ear and eardrum, scoliosis, muscle that do not work on the left side of his face, missing bone in neck and many more birth defects. He has had two heart surgeries and was due for a third. He had a feeding tube, takes medicine (not specified) twice a day for his heart. He almost died when he was born due to his heart. He was on a breathing tube for the first month of his life before his heart surgery. The outcome of the events was reported as not recovered. The events were reported as life threatening, serious (permanent disability, hospitalization (60 days)). Causality was not reported. The reported FLUVIRIN batch number 66521-114 was considered as invalid by quality assurance department and hence no QA investigation can be performed for the case. Follow up received from the quality assurance department on 07 Sep 2015: updated QA comment.
Age: 14.0
Sex: M
Vaccine: HPV4, HPV4
Symptoms: Diarrhoea, Dizziness, Epstein-Barr virus antibody positive, Fatigue, Full blood count abnormal
Clinical narrative: Headache, episodes of dizziness, balance issues. Doesn't feel well. Seen on 6/1/15, patient reported headache, fatigue, sleep problems, nausea, vomiting and chills/sweats.
Age: 14.0
Sex: M
Vaccine: HPV4, HPV4
Symptoms: Headache, Infectious mononucleosis, Insomnia, Platelet count decreased, Pyrexia
Clinical narrative: Headache, episodes of dizziness, balance issues. Doesn't feel well. Seen on 6/1/15, patient reported headache, fatigue, sleep problems, nausea, vomiting and chills/sweats.
Age: 14.0
Sex: M
Vaccine: HPV4, HPV4
Symptoms: Vision blurred
Clinical narrative: Headache, episodes of dizziness, balance issues. Doesn't feel well. Seen on 6/1/15, patient reported headache, fatigue, sleep problems, nausea, vomiting and chills/sweats.
Age: 14.0
Sex: M
Vaccine: HPV4, HPV4
Symptoms: Balance disorder, Band neutrophil count increased, Blood alkaline phosphatase normal, Blood calcium normal, Blood sodium increased
Clinical narrative: Headache, episodes of dizziness, balance issues. Doesn't feel well. Seen on 6/1/15, patient reported headache, fatigue, sleep problems, nausea, vomiting and chills/sweats.
Age: 14.0
Sex: M
Vaccine: HPV4, HPV4
Symptoms: Chills, Dizziness, Epstein-Barr virus antibody positive, Epstein-Barr virus antigen positive, Fatigue
Clinical narrative: Headache, episodes of dizziness, balance issues. Doesn't feel well. Seen on 6/1/15, patient reported headache, fatigue, sleep problems, nausea, vomiting and chills/sweats.
Age: 14.0
Sex: M
Vaccine: HPV4, HPV4
Symptoms: Headache, Hyperhidrosis, Insomnia, Lymphocyte count increased, Lymphocyte morphology abnormal
Clinical narrative: Headache, episodes of dizziness, balance issues. Doesn't feel well. Seen on 6/1/15, patient reported headache, fatigue, sleep problems, nausea, vomiting and chills/sweats.
Age: 14.0
Sex: M
Vaccine: HPV4, HPV4
Symptoms: Malaise, Nausea, Neutrophil count, Neutrophil count decreased, Platelet count decreased
Clinical narrative: Headache, episodes of dizziness, balance issues. Doesn't feel well. Seen on 6/1/15, patient reported headache, fatigue, sleep problems, nausea, vomiting and chills/sweats.
Age: 14.0
Sex: M
Vaccine: HPV4, HPV4
Symptoms: Red blood cell sedimentation rate normal, Urine analysis normal, Vomiting
Clinical narrative: Headache, episodes of dizziness, balance issues. Doesn't feel well. Seen on 6/1/15, patient reported headache, fatigue, sleep problems, nausea, vomiting and chills/sweats.
Sex: F
Vaccine: RAB, RAB
Symptoms: Activities of daily living impaired, Disorientation, Feeling hot, Headache, Hyperhidrosis
Clinical narrative: Case number PHEH2015US017377, is an initial spontaneous report received from a consumer (patient) on 02 Sep 2015. This report refers to a female patient of unknown age. Medical history included neck surgery on an unknown date. Concomitant medication was not reported. The patient received third dose of RABAVERT (batch number: unknown) on 06 Jun 2013. She reported that she experienced convulsions, disorientation and bad joint pain the night of receiving the vaccine. She stated that she suffered a neck injury as a result of the convulsions. She is expecting to have a second neck surgery on unknown date. She stated that she was recently told that her kidneys are starting to fail. The patient was hospitalized for the events. Outcome of the events and causality assessment was not reported. No further information was provided.
Sex: F
Vaccine: RAB, RAB
Symptoms: Musculoskeletal pain, Neck surgery, Seizure
Clinical narrative: Case number PHEH2015US017377, is an initial spontaneous report received from a consumer (patient) on 02 Sep 2015. This report refers to a female patient of unknown age. Medical history included neck surgery on an unknown date. Concomitant medication was not reported. The patient received third dose of RABAVERT (batch number: unknown) on 06 Jun 2013. She reported that she experienced convulsions, disorientation and bad joint pain the night of receiving the vaccine. She stated that she suffered a neck injury as a result of the convulsions. She is expecting to have a second neck surgery on unknown date. She stated that she was recently told that her kidneys are starting to fail. The patient was hospitalized for the events. Outcome of the events and causality assessment was not reported. No further information was provided.
Sex: F
Vaccine: RAB, RAB
Symptoms: Arthralgia, Disorientation, Neck injury, Renal failure, Seizure
Clinical narrative: Case number PHEH2015US017377, is an initial spontaneous report received from a consumer (patient) on 02 Sep 2015. This report refers to a female patient of unknown age. Medical history included neck surgery on an unknown date. Concomitant medication was not reported. The patient received third dose of RABAVERT (batch number: unknown) on 06 Jun 2013. She reported that she experienced convulsions, disorientation and bad joint pain the night of receiving the vaccine. She stated that she suffered a neck injury as a result of the convulsions. She is expecting to have a second neck surgery on unknown date. She stated that she was recently told that her kidneys are starting to fail. The patient was hospitalized for the events. Outcome of the events and causality assessment was not reported. No further information was provided.
Age: 73.0
Sex: F
Vaccine: FLU3, FLU3
Symptoms: Blood test normal, Chest X-ray normal, Chest discomfort, Chills, Electrocardiogram normal
Clinical narrative: Few Minutes after vaccine admninistration the patient get dizziness, flushing skin and high blood presure (158/79) and pulse at 70 bpm. After 5 minutes the BP drops to 135/65 and pulse remains constant at 72bpm with normal skin tone and feel much better.  The next day on 9/8/15 the patient came during the morning and report me that she went to ER because she felt tremors, muscle spasm, nasal and oral secretions, confusion, fever at 102.2 F and low BP.
Age: 73.0
Sex: F
Vaccine: FLU3, FLU3
Symptoms: Nausea, Vomiting
Clinical narrative: Few Minutes after vaccine admninistration the patient get dizziness, flushing skin and high blood presure (158/79) and pulse at 70 bpm. After 5 minutes the BP drops to 135/65 and pulse remains constant at 72bpm with normal skin tone and feel much better.  The next day on 9/8/15 the patient came during the morning and report me that she went to ER because she felt tremors, muscle spasm, nasal and oral secretions, confusion, fever at 102.2 F and low BP.
Age: 73.0
Sex: F
Vaccine: FLU3, FLU3
Symptoms: Confusional state, Dizziness, Flushing, Hypertension, Hypotension
Clinical narrative: Few Minutes after vaccine admninistration the patient get dizziness, flushing skin and high blood presure (158/79) and pulse at 70 bpm. After 5 minutes the BP drops to 135/65 and pulse remains constant at 72bpm with normal skin tone and feel much better.  The next day on 9/8/15 the patient came during the morning and report me that she went to ER because she felt tremors, muscle spasm, nasal and oral secretions, confusion, fever at 102.2 F and low BP.
Age: 73.0
Sex: F
Vaccine: FLU3, FLU3
Symptoms: Increased upper airway secretion, Muscle spasms, Pyrexia, Tremor
Clinical narrative: Few Minutes after vaccine admninistration the patient get dizziness, flushing skin and high blood presure (158/79) and pulse at 70 bpm. After 5 minutes the BP drops to 135/65 and pulse remains constant at 72bpm with normal skin tone and feel much better.  The next day on 9/8/15 the patient came during the morning and report me that she went to ER because she felt tremors, muscle spasm, nasal and oral secretions, confusion, fever at 102.2 F and low BP.
Sex: F
Vaccine: VARZOS
Symptoms: Adenocarcinoma of colon, Biopsy colon abnormal, Colon cancer, Colonoscopy abnormal, Extra dose administered
Clinical narrative: This spontaneous report as received from a physician refers to a female patient of unknown age with allergy to tartrazine.  On 13-JUL-2015, the patient was vaccinated with a first dose of ZOSTAVAX (dose, route of administration, lot # and expiry date were not reported). During the same office visit, the patient was scheduled for early cancer screening. On an unspecified date in 2015 (reported as "within the last week"), the patient received inadvertently the second dose of ZOSTAVAX (dose, route of administration, lot # and expiry date were not reported). On 12-AUG-2015, the patient had a colonoscopy and a biopsy showed adenocarcinoma. The physician reported, that the patient had early colon cancer and would have staging surgery, in September 2015 (reported as "in the next two weeks"). The reporter also stated, that the patient had "no major side effects" (exact onset date unspecified, in 2015). The outcome of the events was unknown. The relatedness between the events and ZOSTAVAX was not provided. Upon internal review the event of adenocarcinoma was considered to be medically significant. Additional information has been requested.
Age: 25.0
Sex: F
Vaccine: HPV9
Symptoms: Headache, Pain, Pyrexia
Clinical narrative: Fever, headache, body aches.
Age: 24.0
Sex: F
Vaccine: HEP, HEPA, VARCEL, HEP, HEPA, VARCEL
Symptoms: Exposure during pregnancy, Pregnancy test positive
Clinical narrative: Patient is pregnant= positive test on 9/8/15.
Age: 24.0
Sex: F
Vaccine: HEP, HEPA, VARCEL, HEP, HEPA, VARCEL
Symptoms: Exposure during pregnancy, No adverse event, Pregnancy test positive
Clinical narrative: Patient is pregnant= positive test on 9/8/15.
Age: 5.0
Sex: M
Vaccine: MM
Symptoms: Pyrexia, Respiratory rate increased, Vomiting, Wheezing
Clinical narrative: Wheezing for 45 minutes. Seemed to have increased respirations. Mother is an RN and gave Benadryl. Wheezing resolved but the following morning he has fever and vomiting. Came in for evaluation.
Age: 15.0
Sex: F
Vaccine: HPV4
Symptoms: C-reactive protein normal, Dizziness, Full blood count normal, Headache, Metabolic function test normal
Clinical narrative: Approximately 15 minutes after receiving vaccine, patient became dizzy at the office check out desk. SHe had a syncope episode. Her mother caught her and she did not hit her head on floor or wall. 8/28/2015 patient back in office complaining of headache on and off and dizziness since episode on 8/26. Physical and neurological exam performed. He diagnosed patient with vertigo and prescribed Meclizine. Labs were drawn and EKG ordered. 9/3/2015 Patient returned to office still complaining of dizziness. This day she was seen again by another doctor...she agreed with diagnosis of vertigo. Additonal labs ran. 9/8/2015 Mom reports patient is back to normal.
Age: 15.0
Sex: F
Vaccine: HPV4
Symptoms: Neurological examination normal, Pregnancy test negative, Red blood cell sedimentation rate normal, Syncope, Urine analysis normal
Clinical narrative: Approximately 15 minutes after receiving vaccine, patient became dizzy at the office check out desk. SHe had a syncope episode. Her mother caught her and she did not hit her head on floor or wall. 8/28/2015 patient back in office complaining of headache on and off and dizziness since episode on 8/26. Physical and neurological exam performed. He diagnosed patient with vertigo and prescribed Meclizine. Labs were drawn and EKG ordered. 9/3/2015 Patient returned to office still complaining of dizziness. This day she was seen again by another doctor...she agreed with diagnosis of vertigo. Additonal labs ran. 9/8/2015 Mom reports patient is back to normal.
Age: 15.0
Sex: F
Vaccine: HPV4
Symptoms: Vertigo
Clinical narrative: Approximately 15 minutes after receiving vaccine, patient became dizzy at the office check out desk. SHe had a syncope episode. Her mother caught her and she did not hit her head on floor or wall. 8/28/2015 patient back in office complaining of headache on and off and dizziness since episode on 8/26. Physical and neurological exam performed. He diagnosed patient with vertigo and prescribed Meclizine. Labs were drawn and EKG ordered. 9/3/2015 Patient returned to office still complaining of dizziness. This day she was seen again by another doctor...she agreed with diagnosis of vertigo. Additonal labs ran. 9/8/2015 Mom reports patient is back to normal.
Age: 71.0
Sex: F
Vaccine: PNC13
Symptoms: Chest pain, Dyspnoea, Myocardial infarction, Nausea, Pulmonary embolism
Clinical narrative: Patient in office to see Dr. for Diabetes 3 mo. visit. Was given a PREVNAR 13 approximately at 10:30 and left office. Patient returned to office at 13:55 with complaints of chest pain, nausea, shortness of breath, sent to Hospital ER. Patient did have a Myocardial Infarction Bilateral Pulmonary Embolisms.
Age: 67.0
Sex: F
Vaccine: PPV
Symptoms: Blood test abnormal, Gait disturbance, Pain
Clinical narrative: Right away next morning pain and soreness moving from one area to another, within 6 days it was so bad I could barely walk. This went on for next 2-3 weeks with 3 trips to urgent care and emergency. After many test RA #s very high. I have been on prednisone, methotrexate and pain meds for over month. I absolutely believe this was all triggered from shot. I was healthy when I went in to begin. Why in Gods name is this shot recommended for otherwise seniors who have been healthy with no prior lung issues? Now I will deal with this for the rest of my life and only.
Age: 74.0
Sex: F
Vaccine: PNC13
Symptoms: Asthenia, Dizziness
Clinical narrative: Dizziness and weakness. Able to ambulate, but does not feel if she will fall, no nausea, SOB, Edema or rash.  Mentating well and does not sound ill when speaking with on call MD.  Advised to take b/p and call back with reading if SBP <100 or if sx worsen.  Observation suggested at time of phone call.
Age: 72.0
Sex: F
Vaccine: PPV
Symptoms: Blood glucose abnormal, Blood test normal, Computerised tomogram head, Decreased appetite, Fatigue
Clinical narrative: Felt extreme fatigue at first then head had a terrible pressure. The next day no appetite and head symptoms worse and fatigue worse. Blood sugar started to not be my normal readings. 1 month I still have symptoms especially fatigue and head pressure with the pneumonia 23 shot.
Age: 72.0
Sex: F
Vaccine: PPV
Symptoms: Head discomfort
Clinical narrative: Felt extreme fatigue at first then head had a terrible pressure. The next day no appetite and head symptoms worse and fatigue worse. Blood sugar started to not be my normal readings. 1 month I still have symptoms especially fatigue and head pressure with the pneumonia 23 shot.
Age: 30.0
Sex: F
Vaccine: FLU4, PPV
Symptoms: Erythema, Peripheral swelling, Skin warm
Clinical narrative: Pt states arm is red, swollen 50% bigger than usual and hot to the touch.
Age: 0.2
Sex: U
Vaccine: DTAP, IPV
Symptoms: Soft tissue injury, Vaccination site reaction
Clinical narrative: Initial unsolicited report received from a healthcare professional (physician's assistant) on 25 August 2015. This case involves a two-month-old patient (gender not reported) who was vaccinated with a dose of DAPTACEL (batch number, expiration date, dose, dose number and route were not reported) and a dose of IPOL (batch number, expiration date, dose, dose number and route were not reported) in left thigh on an unspecified date. Patient medical history and concomitant medications were not reported. On an unspecified date, the patient experienced severe tissue damage to entire upper left thigh where vaccines were administered, much more than dimpling. The dermis was adhering directly to the muscle. At the age of 10 weeks old, the patient was come back to physician for severe tissue damage to entire upper left thigh where vaccines were administered. Laboratory investigation and corrective treatment were not reported. At the time of this report, the outcome of the event was not reported. Upon internal review, company assessed the event of severe tissue damage to entire upper left thigh where vaccines were administered, much more than dimpling, the dermis was adhering directly to the muscle as serious and important medical event. List of documents held by sender: None.
Sex: F
Vaccine: FLUX, PPV
Symptoms: Arthralgia
Clinical narrative: Initial unsolicited report received from a physician on 27 August 2015. This case involves a female patient (age not reported) who was vaccinated with a dose of Influenza vaccine and Pneumococcal vaccine (batch number, dose, route and site of administration was not reported for both vaccines) on an unspecified date. Patient's medical history was not reported and concomitant medications was reported as SYSTANE. On an unspecified date, following the vaccination, the patient experienced arthritis type pain. Lab data and corrective treatments were not reported. Outcome of event was unknown. List of documents held by sender: none.
Age: 79.0
Sex: F
Vaccine: TDAP
Symptoms: Catheterisation cardiac abnormal, Chest pain, Chills, Coronary arterial stent insertion, Musculoskeletal pain
Clinical narrative: Pt developed chills, aches the evening after receiving vaccine. A few day later developed left-sided chest pain radiating to left shoulder.
Age: 79.0
Sex: F
Vaccine: TDAP
Symptoms: Pain
Clinical narrative: Pt developed chills, aches the evening after receiving vaccine. A few day later developed left-sided chest pain radiating to left shoulder.
Age: 39.0
Sex: M
Vaccine: RAB
Symptoms: Headache
Clinical narrative: Bitemporal frontal throbbing headache, 10/10 intensity, lasting 3-5 minutes, reoccurring every 30 min over the past 6 days, unrelieved by advil. No other associated symptoms.
Age: 1.13
Sex: F
Vaccine: HEPA, PNC13
Symptoms: Decreased appetite, Eye swelling, Irritability, Pyrexia, Rash
Clinical narrative: THE MOTHER OF THE PATIENT REFERS THAT THE GIRL DEVELOPED A HIGH FEVER (100° F) THAT LASTED FOR 2 DAYS. THE GIRL WAS ALSO IRRITABLE AND WITHOUT APPETITE.  BY THE THIRD DAY THE GIRL DEVELOPED A RASH IN FACE AND BODY AS WELL A SWOLLEN EYES.
Age: 1.13
Sex: F
Vaccine: HEPA, PNC13
Symptoms: Rash generalised
Clinical narrative: THE MOTHER OF THE PATIENT REFERS THAT THE GIRL DEVELOPED A HIGH FEVER (100° F) THAT LASTED FOR 2 DAYS. THE GIRL WAS ALSO IRRITABLE AND WITHOUT APPETITE.  BY THE THIRD DAY THE GIRL DEVELOPED A RASH IN FACE AND BODY AS WELL A SWOLLEN EYES.
Age: 29.0
Sex: F
Vaccine: TDAP
Symptoms: Bursitis, Mobility decreased, Pain, Vomiting
Clinical narrative: Developed bursitis, diagnosed by physician. Severe pain, significantly limitation of mobility, vomitting due to pain.
Age: 66.0
Sex: F
Vaccine: FLU3
Symptoms: Erythema
Clinical narrative: Redness on upper arm, does not hurt or itch.
Age: 5.0
Sex: M
Vaccine: DTAPH, HEP
Symptoms: Erythema, Injection site warmth, Nausea, Pain, Peripheral swelling
Clinical narrative: Severe swelling of arm, redness, pain, fever, injection site hot, Nausea.
Age: 5.0
Sex: M
Vaccine: DTAPH, HEP
Symptoms: Pyrexia
Clinical narrative: Severe swelling of arm, redness, pain, fever, injection site hot, Nausea.
Age: 0.41
Sex: F
Vaccine: DTAPHEPBIP, HIBV, PNC13, RV1
Symptoms: Haematemesis
Clinical narrative: Vomiting once a day x 3 days with specks of blood.
Age: 20.0
Sex: M
Vaccine: HPV4, MENB
Symptoms: Headache, Pyrexia
Clinical narrative: Headache, fever developed approx 7 hours post injection without nausea, visual changes, MS changes or localized reaction. Fever of 102 approx 11 hours post injection. Sx resolved w/in 24 hrs with Tylenol and supportive home care otherwise.
Age: 79.0
Sex: M
Vaccine: PNC13
Symptoms: Balance disorder, Decreased appetite, Disorientation, Lumbar puncture, Pain
Clinical narrative: Legs hurt so bad he thought he was being paralyzed.  Achy for 2 days then lost appetite, became unsteady, and then became disoriented!!!  Hospitalized on or about 08/30/2015.  Unable to tell name, date, wifes name, where he was, etc.
Age: 79.0
Sex: M
Vaccine: PNC13
Symptoms: Pain in extremity
Clinical narrative: Legs hurt so bad he thought he was being paralyzed.  Achy for 2 days then lost appetite, became unsteady, and then became disoriented!!!  Hospitalized on or about 08/30/2015.  Unable to tell name, date, wifes name, where he was, etc.
Age: 32.0
Sex: F
Vaccine: FLU3
Symptoms: Cough, Fatigue, Influenza like illness, Nasal congestion, Pain
Clinical narrative: Vaccine was given on 9/6/2015 at 5:10 PM and on 9/8/15 at/around 3PM she called and reported that she became sick with flu-like symptoms (nasal/chest congestion, cough, body aching, tiredness) she also went to hospital/ER.
Age: 32.0
Sex: F
Vaccine: FLU3
Symptoms: Respiratory tract congestion
Clinical narrative: Vaccine was given on 9/6/2015 at 5:10 PM and on 9/8/15 at/around 3PM she called and reported that she became sick with flu-like symptoms (nasal/chest congestion, cough, body aching, tiredness) she also went to hospital/ER.
Age: 71.0
Sex: F
Vaccine: FLU3
Symptoms: Cellulitis, Erythema, Peripheral swelling, Rash erythematous, Skin warm
Clinical narrative: Pt reports-red rash and swelling (hot to the touch) in left arm. Severe redness. MD felt it was cellulitis and prescribed KEFLEX 500mg 1 bid x 10d on 09-03-15.
Age: 68.0
Sex: F
Vaccine: FLU3
Symptoms: Eyelid function disorder, Urticaria
Clinical narrative: Patient received High Dose flu shot and Saturday had hives. Went to hospital and recieved steroids and eyes were able to be open 2 days later on the 8th.
Age: 39.0
Sex: M
Vaccine: FLU3
Symptoms: Chills, Cold sweat, Confusional state, Dizziness, Head discomfort
Clinical narrative: 103' Fever, chills, cold sweats throughout 2 nights (9/5 and 9/6) after flu shot. Intense migraine/headache pain and pressure that caused confusion, blurry vision and dizziness from 9/5 to 9/9 (still recurring as of this post).
Age: 39.0
Sex: M
Vaccine: FLU3
Symptoms: Headache, Migraine, Pyrexia, Vision blurred
Clinical narrative: 103' Fever, chills, cold sweats throughout 2 nights (9/5 and 9/6) after flu shot. Intense migraine/headache pain and pressure that caused confusion, blurry vision and dizziness from 9/5 to 9/9 (still recurring as of this post).
Age: 74.0
Sex: F
Vaccine: FLU3
Symptoms: Injection site erythema, Injection site warmth
Clinical narrative: Patient complains of redness and warmth at injection site.
Age: 0.23
Sex: F
Vaccine: HIBV, IPV
Symptoms: Discomfort, Drooling, Infantile spitting up, Screaming
Clinical narrative: Horrible screaming for hours at 5:30, clearly in horrible agony, dramatic increase in frequency of spit up and drool ever since the vaccine was administered.
Age: 4.0
Sex: F
Vaccine: DTAPIPVHIB, PNC13
Symptoms: Bradycardia, Syncope
Clinical narrative: Patient developed syncope approximately 15-20 minutes after administration of DTAP/IPV, Hib, PCV vaccinations. Symptoms self resolved and patient was taken to ER. In ER, patient developed further syncope X1 with bradycardia and required normal saline bolus. Admitted overnight for observation. No further interventions required.
Age: 0.51
Sex: F
Vaccine: DTAPHEPBIP, FLU4, PNC13
Symptoms: Decreased appetite, Insomnia, Irritability, Urticaria
Clinical narrative: Approx 15 hrs after receiving injections patient began to break out in hives all over.  She was fussy, decreased appetite and decreased sleeping.
Age: 70.0
Sex: F
Vaccine: PNC13
Symptoms: Diarrhoea, Erythema, Fatigue, Influenza like illness, Local swelling
Clinical narrative: Diarrhea, vomiting, large amount of swelling in arm, red raised patches on arm, fatigue, "flu like symptoms."
Age: 70.0
Sex: F
Vaccine: PNC13
Symptoms: Peripheral swelling, Vomiting
Clinical narrative: Diarrhea, vomiting, large amount of swelling in arm, red raised patches on arm, fatigue, "flu like symptoms."
Age: 0.17
Sex: M
Vaccine: DTAPHEPBIP, HIBV, PNC13, RV1
Symptoms: Crying, Hypotonia, Moaning, Skin discolouration, Stridor
Clinical narrative: Awoke from nap crying, then moaning, stridor, limp, greenish color, not responsive, lasting about 30 minutes. In Emergency room noted to be wheezing. Resolved with albuterol, Benadryl, prednisolone.
Age: 0.17
Sex: M
Vaccine: DTAPHEPBIP, HIBV, PNC13, RV1
Symptoms: Unresponsive to stimuli, Wheezing
Clinical narrative: Awoke from nap crying, then moaning, stridor, limp, greenish color, not responsive, lasting about 30 minutes. In Emergency room noted to be wheezing. Resolved with albuterol, Benadryl, prednisolone.
Age: 69.0
Sex: M
Vaccine: FLU3, PPV
Symptoms: Chills, Heart rate decreased, Pyrexia, Rash
Clinical narrative: Per patient's wife, patient started experiencing symptoms which included rash on the under part of the arm - not at the site of the injection, slow heart rate, and fever/chills, approximately 8 hours after receiving vaccines (Fluzone HD and Pneumovax).  Both were given in the Left Deltoid approximately 1 inch apart. According to wife, symptoms lasted approximately 48 hours. Patient is doing better and did not seek medical attention during this time.
Age: 77.0
Sex: F
Vaccine: FLU3, PPV
Symptoms: Diarrhoea, Injection site erythema, Injection site swelling, Vomiting
Clinical narrative: SWELLING AND REDNESS AT SITE OF SHOT, VOMITING AND DIARRHEA. DR PRESCRIBED ZOFRAN.
Age: 28.0
Sex: M
Vaccine: PPV
Symptoms: Arthralgia, Chills, Pain, Pruritus, Pyrexia
Clinical narrative: Patient received IM vaccination in left arm. About 6 hours after receiving vaccination, he experienced joint pain, fever, chills, and a rash extending to chest and elbow. The area was very painful and itchy. 7 days later, the rash and pain are gone, but the area is still itchy.
Age: 28.0
Sex: M
Vaccine: PPV
Symptoms: Rash
Clinical narrative: Patient received IM vaccination in left arm. About 6 hours after receiving vaccination, he experienced joint pain, fever, chills, and a rash extending to chest and elbow. The area was very painful and itchy. 7 days later, the rash and pain are gone, but the area is still itchy.
Age: 54.0
Sex: F
Vaccine: FLU3
Symptoms: Adverse event
Clinical narrative: As relayed to us by family member, Pt. was taken to hospital in critical condition but as of now doctor's not sure what is the cause of her condition.
Age: 71.0
Sex: F
Vaccine: FLU3, PPV
Symptoms: Injected limb mobility decreased, Injection site swelling, Myalgia
Clinical narrative: Swelling between neck and elbow in right arm.  Limited mobility in right arm.  Muscle pain in right arm after receiving Pneumovax 23.
Age: 30.0
Sex: F
Vaccine: FLU3, VARCEL
Symptoms: Cold sweat, Feeling cold, Hyperhidrosis, Nausea, Paraesthesia
Clinical narrative: 9/1 Client called to report extreme vertigo, sweating, nausea, feels cold, clammy and tingling in hands. Advised client to see PCP. Stated had taken promethazine and nausea was somewhat better. Spoke w/ client later that day-was at E.R. 9/2 Spoke w/ client. Treated w/ Rx for promethazine and ANTIVERT. Feels better. 9/3 Spoke w/ client. Sx resolving.
Age: 30.0
Sex: F
Vaccine: FLU3, VARCEL
Symptoms: Vertigo
Clinical narrative: 9/1 Client called to report extreme vertigo, sweating, nausea, feels cold, clammy and tingling in hands. Advised client to see PCP. Stated had taken promethazine and nausea was somewhat better. Spoke w/ client later that day-was at E.R. 9/2 Spoke w/ client. Treated w/ Rx for promethazine and ANTIVERT. Feels better. 9/3 Spoke w/ client. Sx resolving.
Age: 81.0
Sex: F
Vaccine: FLU3
Symptoms: Headache
Clinical narrative: Patient complained of a headache that started in the night and has not gone away yet.
Age: 75.0
Sex: F
Vaccine: FLU3
Symptoms: Dizziness
Clinical narrative: Feeling lightheadedness an hour after receiving vaccine. Called pt to follow up and she is feeling better.
Age: 74.0
Sex: U
Vaccine: FLU3, PPV
Symptoms: Condition aggravated, Muscular weakness, Neurological decompensation
Clinical narrative: Progressive weakness of low extremities-had progressive neurologic decline due to dementia but rapid weakness after vaccine.
Sex: U
Vaccine: HPV4
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report was received from an administrator and refers to two patients of unknown age and gender. No information regarding the patient's pertinent medical history, concomitant medication and drug reactions or allergies was reported. On an unspecified date, the patients were vaccinated with doses of improperly stored GARDASIL 9, lot # L004741, expiration date 04-MAR-2017 (strength, dose, frequency and route of administration were not provided). No adverse effects were reported. This is one of two reports received from the same source. Additional information has been requested.
Age: 65.0
Sex: F
Vaccine: FLU3
Symptoms: Asthenia, Conjunctivitis, Dry mouth, Dysgeusia, Dyspnoea
Clinical narrative: At 4 PM I started to get a severe sore throat and very bad runny nose-by 730PM I was in bed in pain-weak-difficulty breathing, headache-I am not a sleeper but I felt I passed out for 6 solid hours. When I woke I struggled to get out of bed-very weak-lot of body pain-stumbling so weak. Took a lot of TYLENOL to try to help. Mucus eyes almost like pink eye/red/swollen. Dry mouth/lips. Bad taste. Slight fever. Generally in the past I'll get the sore arm and generally a sore throat. This time was scary. Should I get a flu shot next year?
Age: 65.0
Sex: F
Vaccine: FLU3
Symptoms: Eye discharge, Eye swelling, Headache, Lip dry, Loss of consciousness
Clinical narrative: At 4 PM I started to get a severe sore throat and very bad runny nose-by 730PM I was in bed in pain-weak-difficulty breathing, headache-I am not a sleeper but I felt I passed out for 6 solid hours. When I woke I struggled to get out of bed-very weak-lot of body pain-stumbling so weak. Took a lot of TYLENOL to try to help. Mucus eyes almost like pink eye/red/swollen. Dry mouth/lips. Bad taste. Slight fever. Generally in the past I'll get the sore arm and generally a sore throat. This time was scary. Should I get a flu shot next year?
Age: 65.0
Sex: F
Vaccine: FLU3
Symptoms: Ocular hyperaemia, Oropharyngeal pain, Pain, Pyrexia, Rhinorrhoea
Clinical narrative: At 4 PM I started to get a severe sore throat and very bad runny nose-by 730PM I was in bed in pain-weak-difficulty breathing, headache-I am not a sleeper but I felt I passed out for 6 solid hours. When I woke I struggled to get out of bed-very weak-lot of body pain-stumbling so weak. Took a lot of TYLENOL to try to help. Mucus eyes almost like pink eye/red/swollen. Dry mouth/lips. Bad taste. Slight fever. Generally in the past I'll get the sore arm and generally a sore throat. This time was scary. Should I get a flu shot next year?
Age: 36.0
Sex: F
Vaccine: FLU3
Symptoms: Erythema, Pain, Pruritus, Swelling
Clinical narrative: EE c/o swelling, redness, itchy and pain that began 1-2 hrs after receiving flu shot on 9/8/15. Presents 9/9/15 for treatment. Denies home care.
Sex: U
Vaccine: HEP, RV5, HEP
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: Information has been received from a registered nurse referring to a patient of unknown age and gender. The patient's pertinent medical history and drug reactions/allergies were not reported. On an unknown date, the patient was vaccinated with REOCMBIVAX HB (dose, lot# and route were not reported), which was improperly stored. No adverse effects were reported. This is one of several cases from the same reporter. Additional information has been requested.
Age: 23.0
Sex: M
Vaccine: HEP
Symptoms: Constipation, Fatigue, Insomnia, Musculoskeletal stiffness, Myalgia
Clinical narrative: This spontaneous report was received from the patient's mother and refers to currently 23 years old male patient. The patient's medical history and current conditions were not reported. On an unknown date, the patient was vaccinated with RECOMBIVAX HB (dose, route of administration, lot number and expire date were not reported). No concomitant therapy was reported. On an unknown date, after receiving RECOMBIVAX HB, the patient experienced fatigue, muscle ache, stiffness in the back and neck, constipation, drowsiness, and sleeplessness. The patient sought medical attention (call physician). The patient's outcome was not reported. The relatedness between the vaccination with RECOMBIVAX HB and the adverse events was not reported. Additional information has been requested.