chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Sex: U
Vaccine: HPV4
Symptoms: Myalgia, Neck pain, Pyrexia, VIIth nerve paralysis
Clinical narrative: This spontaneous report as received from a nurse practitioner refers to a patient (reported as student) of unknown age. The patient's medical history was not reported. On an unknown date the patient was vaccinated with 1st dose of GARDASIL. Concomitant therapies included ATIVAN 1 milligram (mg) administered an hour before the GARDASIL. No adverse effects occurred after the first dose. On an unknown date the patient was vaccinated with 2nd dose of GARDASIL. ATIVAN 1 mg was administered an hour before the GARDASIL vaccination. On an unknown date (reported as within an unspecified period) after receiving GARDASIL the patient experienced lightheaded, dizzy, had a migraine, had insomnia, felt feverish, and had numbness on the right side of the face. The patient also had a neck pain. The patient experienced Bell's palsy within 24 hours of second dose as per diagnosis of another health care professional (HCP). Other symptoms included headaches, dizziness, insomnia and muscle pain. The outcome of lightheaded, dizzy, had a migraine, had insomnia, felt feverish, neck pain, numbness on the right side of the face and Bell's palsy was unknown. The relatedness of the events with the therapy was not reported. Additional information has been requested.
Age: 80.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site rash, Injection site vesicles
Clinical narrative: This spontaneous report as received from a pharmacist refers to a female patient of unknown age. The patient's pertinent medical history was reported as may be high blood pressure and drug reactions/allergies to latex. Concomitant therapies included hydrochlorothiazide (manufacturer unknown). The pharmacist reported that on 19-MAY-2014 after the patient was vaccinated with ZOSTAVAX lot # J013449 expiration date- 24-JAN-2015, dose 0.65 ml, route subcutaneous the patient developed blistering at injection site which looked like rash. No lab/diagnostic studies were performed. The outcome of blistering at injection site which looks like rash is reported to be Not Recovered/Not Resolved. The patient sought medical attention. No product quality complaint was involved. Additional information has been requested.
Age: 48.0
Sex: F
Vaccine: FLU3
Symptoms: Complex regional pain syndrome, Injected limb mobility decreased, Neck pain, Pain in extremity
Clinical narrative: Case number PHHY2012US098996, is an initial spontaneous report received from Vaccine Adverse Event Reporting System (VAERS reference number: 462656) web site on 01 Nov 2012, and with a follow up report received from QA department (QA reference number: 209586) on 19 May 2014. This report refers to 48 year old female patient. Her medical history and concomitant medications were not reported. She was vaccinated with FLUVIRIN (batch number: 1100101, expiration date: 30 Apr 2012), IM into the left arm on 08 Sep 2011. On the same day the patient had pain from left hand up to her neck and could not move her arm. The pharmacist later told her to put ice on it. Her symptoms remained, so she has undergone trigger point therapy and 3 stellate ganglion nerve blocks. She states she is on pain management therapy. She was diagnosed with reflex sympathetic dystrophy. The outcome of the events, seriousness and causality assessment was not reported. Based on the document review, it was stated that the FLUVIRIN, batch number 1100101 was manufactured in accordance with approved internal procedures and it was in compliance with the current good manufacturing practices (cGMP) requirements. Follow up report received from QA department (QA reference number: 209586) on 19 May 2014. Updated batch review report.
Age: 11.0
Sex: M
Vaccine: RAB
Symptoms: Ataxia, Blood culture, Full blood count, Headache, International normalised ratio
Clinical narrative: Case number PHHY2013US097143, is an initial spontaneous report received from the Vaccine Adverse Event Reporting System (VAERS reference number: 491980) website on 05 Sep 2013 and a follow-up received from Quality Assurance Department (QA, reference number: 250937) on 15 May 2014. This report refers to a 11-year-old male patient. His medical history included no known drug allergies, ADHA (attention deficit hyperactivity disorder) and bipolar disorder. He was vaccinated with RABAVERT (batch number: 524011C) via intramuscular route in the right arm on 19 May 2013. On the same date, 15 minutes after vaccination he experienced headache, ataxia, nausea, and vomited once. The patient visited the emergency room for further evaluation. He received TYLENOL and ZOFRAN as treatment drugs. In the emergency room he underwent Complete Blood Count (CBC), Comprehensive Metabolic Panel test (CMP), Prothrombin Time (PT) with INR (International normalized ratio), urinalysis, and blood cultures. But results were not provided. The patient recovered from the events on same day. The seriousness and causality of the events were not reported. Based on the batch investigation performed, the QA department stated that the RABAVERT (batch number: 524011C) was manufactured in accordance with the approved internal procedures and it was in compliance with the cGMP requirements. Follow-up received from Quality Assurance Department (QA, reference number: 250937) on 15 May 2014: Updated batch review report.
Age: 11.0
Sex: M
Vaccine: RAB
Symptoms: Metabolic function test, Nausea, Prothrombin time, Urine analysis, Vomiting
Clinical narrative: Case number PHHY2013US097143, is an initial spontaneous report received from the Vaccine Adverse Event Reporting System (VAERS reference number: 491980) website on 05 Sep 2013 and a follow-up received from Quality Assurance Department (QA, reference number: 250937) on 15 May 2014. This report refers to a 11-year-old male patient. His medical history included no known drug allergies, ADHA (attention deficit hyperactivity disorder) and bipolar disorder. He was vaccinated with RABAVERT (batch number: 524011C) via intramuscular route in the right arm on 19 May 2013. On the same date, 15 minutes after vaccination he experienced headache, ataxia, nausea, and vomited once. The patient visited the emergency room for further evaluation. He received TYLENOL and ZOFRAN as treatment drugs. In the emergency room he underwent Complete Blood Count (CBC), Comprehensive Metabolic Panel test (CMP), Prothrombin Time (PT) with INR (International normalized ratio), urinalysis, and blood cultures. But results were not provided. The patient recovered from the events on same day. The seriousness and causality of the events were not reported. Based on the batch investigation performed, the QA department stated that the RABAVERT (batch number: 524011C) was manufactured in accordance with the approved internal procedures and it was in compliance with the cGMP requirements. Follow-up received from Quality Assurance Department (QA, reference number: 250937) on 15 May 2014: Updated batch review report.
Age: 46.0
Sex: F
Vaccine: RAB
Symptoms: Chest discomfort, Paraesthesia, Paraesthesia oral, Swelling, Swollen tongue
Clinical narrative: Case number PHHY2014US001011, is an initial spontaneous report received from a nurse via Vaccine Adverse Event Reporting System (VAERS reference number: 512448) website on 06 Jan 2014 and a follow-up received from Quality Assurance Department (QA, reference number: 274131) on 15 May 2014. This report refers to a 46-year-old female patient. Past medical history included multiple allergies: penicillin (PCN), sulfonamides, CLINIDA, DARVOCET, Codeine, allergy to a vaccine, post-traumatic stress disorder, anxiety, irritable bowel syndrome (IBS), colitis and Bell's palsy. Concomitant medications were not reported. She was vaccinated with a dose of IMOVAX (batch number: not reported) on an unknown date previously. On 20 Oct 2013, she was vaccinated with post exposure RABAVERT (batch number: 532011A) vaccine into the left deltoid and RIG (immunoglobulin human anti-rabies, unknown manufacturer, batch number: not reported) into the bite wound into the hand. She was vaccinated with IMOVAX (other manufacturer, batch number: H1512-3) into the right deltoid on 23 Oct 2013. On 23 Oct 2013, she experienced tightness in chest, tingling in her throat and tongue with mild swelling on the right side. She was hospitalized on an unknown date (duration not reported). On an unknown date, her vitals were normal and her body temperature was not measured. Treatment rendered was not provided. The outcome of the events was reported as condition unchanged as of 07 Nov 2013. The seriousness and causality of the events were not reported. Based on the batch investigation performed, the QA department stated that, the RABAVERT (batch number: 532011A) was manufactured in accordance with the approved internal procedures and it was in compliance with the cGMP requirements. Follow-up received from Quality Assurance Department (QA, reference number: 274131) on 15 May 2014: Updated batch review report.
Age: 37.0
Sex: M
Vaccine: FLU3
Symptoms: Acute disseminated encephalomyelitis, Angiogram abnormal, Asthenia, Computerised tomogram head normal, Headache
Clinical narrative: Case number PHHY2014US013356 is an initial spontaneous report received from Vaccine Adverse Event Reporting System (VAERS reference number: 516582) website on 03 Feb 2014 with a follow up report received from Quality Assurance Department (QA, reference number: 295812) on 20 May 2014. This report refers to a 37-year-old male patient. His medical history was not reported. His concomitant medication included MOTRIN. He was vaccinated with FLUVIRIN (batch number: 1309401) intramuscularly in the left arm on 05 Nov 2013. On an unknown date after vaccination, he experienced global headache for one week which was treated with NSAID (Non-steroidal anti-inflammatory drug); however, there was no relief. He developed paresthesia in his left forearm along with subjective weakness upon awakening on 06 Dec 2013. His blood pressure was recorded as 140/94 and he was sent to the hospital to evaluate the probability of transient ischemic attack versus anginal equivalent. Medical professional at the emergency room (ER) thought he had complex migraine since he developed photophobia in one eye along with headache. They did not suspect any cardiac problem. Scanned head computed tomography (CT) was negative for any abnormalities. He was seen by a neurologist. Magnetic resonance imaging (MRI) and magnetic resonance angiography (MRA) was performed that revealed acute disseminated encephalomyelitis (ADEM). He was following up with his neurologist at the time of reporting. Final outcome of the events was reported as condition unchanged as of 13 Dec 2013. No further information about seriousness and causality was reported. Based on the batch review performed, it was concluded that the FLUVIRIN batch number: 1309401 was manufactured in accordance with the approved internal procedures and in compliance with the cGMP requirements. Non-significant follow-up received from Quality Assurance Department (reference number: 295812) on 24 Apr 2014: Updated QA reference number only. Follow up report received from QA department on 20 May 2014: Updated batch review report.
Age: 37.0
Sex: M
Vaccine: FLU3
Symptoms: Hypertension, Migraine, Nuclear magnetic resonance imaging brain abnormal, Paraesthesia, Photophobia
Clinical narrative: Case number PHHY2014US013356 is an initial spontaneous report received from Vaccine Adverse Event Reporting System (VAERS reference number: 516582) website on 03 Feb 2014 with a follow up report received from Quality Assurance Department (QA, reference number: 295812) on 20 May 2014. This report refers to a 37-year-old male patient. His medical history was not reported. His concomitant medication included MOTRIN. He was vaccinated with FLUVIRIN (batch number: 1309401) intramuscularly in the left arm on 05 Nov 2013. On an unknown date after vaccination, he experienced global headache for one week which was treated with NSAID (Non-steroidal anti-inflammatory drug); however, there was no relief. He developed paresthesia in his left forearm along with subjective weakness upon awakening on 06 Dec 2013. His blood pressure was recorded as 140/94 and he was sent to the hospital to evaluate the probability of transient ischemic attack versus anginal equivalent. Medical professional at the emergency room (ER) thought he had complex migraine since he developed photophobia in one eye along with headache. They did not suspect any cardiac problem. Scanned head computed tomography (CT) was negative for any abnormalities. He was seen by a neurologist. Magnetic resonance imaging (MRI) and magnetic resonance angiography (MRA) was performed that revealed acute disseminated encephalomyelitis (ADEM). He was following up with his neurologist at the time of reporting. Final outcome of the events was reported as condition unchanged as of 13 Dec 2013. No further information about seriousness and causality was reported. Based on the batch review performed, it was concluded that the FLUVIRIN batch number: 1309401 was manufactured in accordance with the approved internal procedures and in compliance with the cGMP requirements. Non-significant follow-up received from Quality Assurance Department (reference number: 295812) on 24 Apr 2014: Updated QA reference number only. Follow up report received from QA department on 20 May 2014: Updated batch review report.
Age: 37.0
Sex: M
Vaccine: FLU3
Symptoms: Transient ischaemic attack
Clinical narrative: Case number PHHY2014US013356 is an initial spontaneous report received from Vaccine Adverse Event Reporting System (VAERS reference number: 516582) website on 03 Feb 2014 with a follow up report received from Quality Assurance Department (QA, reference number: 295812) on 20 May 2014. This report refers to a 37-year-old male patient. His medical history was not reported. His concomitant medication included MOTRIN. He was vaccinated with FLUVIRIN (batch number: 1309401) intramuscularly in the left arm on 05 Nov 2013. On an unknown date after vaccination, he experienced global headache for one week which was treated with NSAID (Non-steroidal anti-inflammatory drug); however, there was no relief. He developed paresthesia in his left forearm along with subjective weakness upon awakening on 06 Dec 2013. His blood pressure was recorded as 140/94 and he was sent to the hospital to evaluate the probability of transient ischemic attack versus anginal equivalent. Medical professional at the emergency room (ER) thought he had complex migraine since he developed photophobia in one eye along with headache. They did not suspect any cardiac problem. Scanned head computed tomography (CT) was negative for any abnormalities. He was seen by a neurologist. Magnetic resonance imaging (MRI) and magnetic resonance angiography (MRA) was performed that revealed acute disseminated encephalomyelitis (ADEM). He was following up with his neurologist at the time of reporting. Final outcome of the events was reported as condition unchanged as of 13 Dec 2013. No further information about seriousness and causality was reported. Based on the batch review performed, it was concluded that the FLUVIRIN batch number: 1309401 was manufactured in accordance with the approved internal procedures and in compliance with the cGMP requirements. Non-significant follow-up received from Quality Assurance Department (reference number: 295812) on 24 Apr 2014: Updated QA reference number only. Follow up report received from QA department on 20 May 2014: Updated batch review report.
Age: 53.0
Sex: F
Vaccine: FLU3, FLU3
Symptoms: Bacterial infection, Pain in extremity
Clinical narrative: Case number PHHY2014US046052 is an initial spontaneous report received from the vaccine adverse event reporting system (VAERS reference number: 519179) web site on 14 Apr 2014, and with a follow up report received from QA department (reference number: 294983) on 16 May 2014. This report refers to a 53 year old female patient. Her medical history and concomitant medications were not reported. She was vaccinated with FLUVIRIN (batch number: 1310201) in the right arm on 08 Jan 2014. On 09 Jan 2014, her right arm was sore which continued even after 5 days. She went to emergency room and the physician diagnosed bacterial infection by observation. The event was reported non serious, however it was internally upgraded as medically significant by the MAH. The event outcome was reported as complete recovery. The causality was not reported. Based on the batch review, it was stated that the FLUVIRIN, batch number 1310201 was manufactured in accordance with approved internal procedures and it was in compliance with the current good manufacturing practices (CGMP) requirements. Follow up report received from QA department (reference number: 294983) on 16 May 2014. Updated batch review report.
Age: 59.0
Sex: M
Vaccine: FLU3, FLU3
Symptoms: Furuncle, Injection site erythema, Injection site reaction, Injection site swelling
Clinical narrative: Case number PHHY2014US045497 is an initial spontaneous report received from the vaccine adverse event reporting system (VAERS reference number: 522140) web site on 08 Apr 2014 with a follow up was received from Quality Assurance Department (reference number: 294861) on 13 May 2014. This report refers to a 59 year old male patient. His past medical history and concomitant medications were not reported. He was vaccinated with FLUVIRIN (batch number: 13471P) into his left arm on 01 Nov 2013. On 07 Nov 2013, he developed redness, swelling and a pus filled boil at the vaccination site. The outcome of the events was not reported. The event pus filled boil at vaccination site was reported as non-serious; however the case was internally upgraded as medically significant by the agency and the causality of the events was not reported. Batch review report concluded that, based on the document review, it was stated that, the concerned with FLUVIRIN (batch number: 13471P) was manufactured in accordance with approved internal procedures and it was in compliance with the current good manufacturing practices (cGMP) requirements. Follow up report received from quality assurance department on 13 May 2014: Updated batch review report. Non-significant follow up report received from QA department on 20 May 2014: Received batch review report.
Age: 59.0
Sex: M
Vaccine: FLU3, FLU3
Symptoms: Furuncle, Injection site erythema, Vaccination site reaction, Vaccination site swelling
Clinical narrative: Case number PHHY2014US045497 is an initial spontaneous report received from the vaccine adverse event reporting system (VAERS reference number: 522140) web site on 08 Apr 2014 with a follow up was received from Quality Assurance Department (reference number: 294861) on 13 May 2014. This report refers to a 59 year old male patient. His past medical history and concomitant medications were not reported. He was vaccinated with FLUVIRIN (batch number: 13471P) into his left arm on 01 Nov 2013. On 07 Nov 2013, he developed redness, swelling and a pus filled boil at the vaccination site. The outcome of the events was not reported. The event pus filled boil at vaccination site was reported as non-serious; however the case was internally upgraded as medically significant by the agency and the causality of the events was not reported. Batch review report concluded that, based on the document review, it was stated that, the concerned with FLUVIRIN (batch number: 13471P) was manufactured in accordance with approved internal procedures and it was in compliance with the current good manufacturing practices (cGMP) requirements. Follow up report received from quality assurance department on 13 May 2014: Updated batch review report. Non-significant follow up report received from QA department on 20 May 2014: Received batch review report.
Age: 23.0
Sex: F
Vaccine: RAB, RAB
Symptoms: Malaise, Sinus tachycardia, Supraventricular tachycardia, Tachycardia, Valsalva maneuver
Clinical narrative: Case number PHEH2014US010453 is an initial spontaneous report received from a pharmacist on 19 May 2014. This report refers to a 23-years-old female patient. She had no medical or allergy history. Her concomitant medications were not reported. Her vaccination history included two doses of RABAVERT (batch number: not reported) post exposure prophylaxis at the emergency department without any complaints on 11 May 2014 and 14 May 2014 respectively. She was administered the third dose of RABAVERT (batch number: 532011A) intramuscularly on 18 May 2014. It was reported that she experienced two episodes of rapid tachycardia on 18 May 2014 after third dose. The episode was described as follows: 20 minutes after the third dose, she complained that she was not feeling well. Upon examination, she had a heart rate in the 170's and was determined to be having supraventricular tachycardia (SVT). The physician gave a valsava maneuver which brought the heart rate down to a normal sinus tachycardia. It was reported that after 20 minutes, she again experienced SVT which was managed with a valsava maneuver along with Lopressor to bring the heart rate to normal. She was not admitted to the hospital. The event outcome was unknown. The seriousness and causality were not reported.
Age: 23.0
Sex: F
Vaccine: RAB, RAB
Symptoms: Heart rate increased, Malaise, Supraventricular tachycardia
Clinical narrative: Case number PHEH2014US010453 is an initial spontaneous report received from a pharmacist on 19 May 2014. This report refers to a 23-years-old female patient. She had no medical or allergy history. Her concomitant medications were not reported. Her vaccination history included two doses of RABAVERT (batch number: not reported) post exposure prophylaxis at the emergency department without any complaints on 11 May 2014 and 14 May 2014 respectively. She was administered the third dose of RABAVERT (batch number: 532011A) intramuscularly on 18 May 2014. It was reported that she experienced two episodes of rapid tachycardia on 18 May 2014 after third dose. The episode was described as follows: 20 minutes after the third dose, she complained that she was not feeling well. Upon examination, she had a heart rate in the 170's and was determined to be having supraventricular tachycardia (SVT). The physician gave a valsava maneuver which brought the heart rate down to a normal sinus tachycardia. It was reported that after 20 minutes, she again experienced SVT which was managed with a valsava maneuver along with Lopressor to bring the heart rate to normal. She was not admitted to the hospital. The event outcome was unknown. The seriousness and causality were not reported.
Age: 42.0
Sex: F
Vaccine: TTOX, YF, TTOX, YF
Symptoms: Body temperature increased, Endotracheal intubation, Mechanical ventilation, Mental status changes, Muscle contractions involuntary
Clinical narrative: Patient was administered a yellow fever vaccine and tetanus 5/16/14 prior to admission to our facility. Patient presented to the emergency room with altered mental status, shortness of breath and involuntary muscle contractions. Patient was planning a trip abroad. Patient also developed temperature up to 102F. Diagnosis of tardive dyskinesia, respiratory failure and adverse reaction to yellow fever vaccine. Had been doing well till 5/19 - fairly acute onset of involuntary movements of body. Fever. UTI - on UA. Some sore throat before this. No travel (recvd yellow fever and tetanus vaccine prior to traveling 5/16), exposures, cough, headache, visual disturbances). Persistent myoclonic like movements - Whole body since 5/19. Worse since admit - no response to BENADRYL or COGENTIN. Minimal response to IV diazepam (> 20mg). Need for increased sedation, drip, propofol - Patient intubated.
Age: 42.0
Sex: F
Vaccine: TTOX, YF, TTOX, YF
Symptoms: Unresponsive to stimuli
Clinical narrative: Patient was administered a yellow fever vaccine and tetanus 5/16/14 prior to admission to our facility. Patient presented to the emergency room with altered mental status, shortness of breath and involuntary muscle contractions. Patient was planning a trip abroad. Patient also developed temperature up to 102F. Diagnosis of tardive dyskinesia, respiratory failure and adverse reaction to yellow fever vaccine. Had been doing well till 5/19 - fairly acute onset of involuntary movements of body. Fever. UTI - on UA. Some sore throat before this. No travel (recvd yellow fever and tetanus vaccine prior to traveling 5/16), exposures, cough, headache, visual disturbances). Persistent myoclonic like movements - Whole body since 5/19. Worse since admit - no response to BENADRYL or COGENTIN. Minimal response to IV diazepam (> 20mg). Need for increased sedation, drip, propofol - Patient intubated.
Age: 42.0
Sex: F
Vaccine: TTOX, YF, TTOX, YF
Symptoms: Cough, Dyskinesia, Dyspnoea, Endotracheal intubation, Headache
Clinical narrative: Patient was administered a yellow fever vaccine and tetanus 5/16/14 prior to admission to our facility. Patient presented to the emergency room with altered mental status, shortness of breath and involuntary muscle contractions. Patient was planning a trip abroad. Patient also developed temperature up to 102F. Diagnosis of tardive dyskinesia, respiratory failure and adverse reaction to yellow fever vaccine. Had been doing well till 5/19 - fairly acute onset of involuntary movements of body. Fever. UTI - on UA. Some sore throat before this. No travel (recvd yellow fever and tetanus vaccine prior to traveling 5/16), exposures, cough, headache, visual disturbances). Persistent myoclonic like movements - Whole body since 5/19. Worse since admit - no response to BENADRYL or COGENTIN. Minimal response to IV diazepam (> 20mg). Need for increased sedation, drip, propofol - Patient intubated.
Age: 42.0
Sex: F
Vaccine: TTOX, YF, TTOX, YF
Symptoms: Mental status changes, Muscle contractions involuntary, Myoclonus, Oropharyngeal pain, Pyrexia
Clinical narrative: Patient was administered a yellow fever vaccine and tetanus 5/16/14 prior to admission to our facility. Patient presented to the emergency room with altered mental status, shortness of breath and involuntary muscle contractions. Patient was planning a trip abroad. Patient also developed temperature up to 102F. Diagnosis of tardive dyskinesia, respiratory failure and adverse reaction to yellow fever vaccine. Had been doing well till 5/19 - fairly acute onset of involuntary movements of body. Fever. UTI - on UA. Some sore throat before this. No travel (recvd yellow fever and tetanus vaccine prior to traveling 5/16), exposures, cough, headache, visual disturbances). Persistent myoclonic like movements - Whole body since 5/19. Worse since admit - no response to BENADRYL or COGENTIN. Minimal response to IV diazepam (> 20mg). Need for increased sedation, drip, propofol - Patient intubated.
Age: 42.0
Sex: F
Vaccine: TTOX, YF, TTOX, YF
Symptoms: Respiratory failure, Tardive dyskinesia, Urinary tract infection, Urine analysis abnormal, Vaccination complication
Clinical narrative: Patient was administered a yellow fever vaccine and tetanus 5/16/14 prior to admission to our facility. Patient presented to the emergency room with altered mental status, shortness of breath and involuntary muscle contractions. Patient was planning a trip abroad. Patient also developed temperature up to 102F. Diagnosis of tardive dyskinesia, respiratory failure and adverse reaction to yellow fever vaccine. Had been doing well till 5/19 - fairly acute onset of involuntary movements of body. Fever. UTI - on UA. Some sore throat before this. No travel (recvd yellow fever and tetanus vaccine prior to traveling 5/16), exposures, cough, headache, visual disturbances). Persistent myoclonic like movements - Whole body since 5/19. Worse since admit - no response to BENADRYL or COGENTIN. Minimal response to IV diazepam (> 20mg). Need for increased sedation, drip, propofol - Patient intubated.
Age: 42.0
Sex: F
Vaccine: TTOX, YF, TTOX, YF
Symptoms: Visual impairment
Clinical narrative: Patient was administered a yellow fever vaccine and tetanus 5/16/14 prior to admission to our facility. Patient presented to the emergency room with altered mental status, shortness of breath and involuntary muscle contractions. Patient was planning a trip abroad. Patient also developed temperature up to 102F. Diagnosis of tardive dyskinesia, respiratory failure and adverse reaction to yellow fever vaccine. Had been doing well till 5/19 - fairly acute onset of involuntary movements of body. Fever. UTI - on UA. Some sore throat before this. No travel (recvd yellow fever and tetanus vaccine prior to traveling 5/16), exposures, cough, headache, visual disturbances). Persistent myoclonic like movements - Whole body since 5/19. Worse since admit - no response to BENADRYL or COGENTIN. Minimal response to IV diazepam (> 20mg). Need for increased sedation, drip, propofol - Patient intubated.
Age: 81.0
Sex: F
Vaccine: VARZOS, VARZOS
Symptoms: Blood blister, Haemorrhage, Immediate post-injection reaction
Clinical narrative: This spontaneous report as received from a pharmacist refers to an 81 year old female patient with hypertension and osteoporosis. On 22-MAY-2014 the patient was vaccinated with ZOSTAVAX, 0.65 ml once, subcutaneously in the right deltoid (lot # not reported). Concomitant therapies included metoprolol, amlodipine and aspirin 81 mg daily. The pharmacist reported that today, on 22-MAY-2014, when she withdrew the injection needle from the patient's subcutaneous tissue after administration of ZOSTAVAX, a hematoma "about the size of a quarter" began to form. She asked the patient to apply light pressure to the injection site and to sit in the waiting room of the pharmacy for a few minutes so that the pharmacist could monitor her. The only other adverse experience that the patient reported was that the injection of ZOSTAVAX "stung a little bit." The patient was currently recovering. Additional information has been requested,
Age: 81.0
Sex: F
Vaccine: VARZOS, VARZOS
Symptoms: Injection site haematoma, Injection site pain
Clinical narrative: This spontaneous report as received from a pharmacist refers to an 81 year old female patient with hypertension and osteoporosis. On 22-MAY-2014 the patient was vaccinated with ZOSTAVAX, 0.65 ml once, subcutaneously in the right deltoid (lot # not reported). Concomitant therapies included metoprolol, amlodipine and aspirin 81 mg daily. The pharmacist reported that today, on 22-MAY-2014, when she withdrew the injection needle from the patient's subcutaneous tissue after administration of ZOSTAVAX, a hematoma "about the size of a quarter" began to form. She asked the patient to apply light pressure to the injection site and to sit in the waiting room of the pharmacy for a few minutes so that the pharmacist could monitor her. The only other adverse experience that the patient reported was that the injection of ZOSTAVAX "stung a little bit." The patient was currently recovering. Additional information has been requested,
Age: 87.0
Sex: F
Vaccine: TDAP
Symptoms: Aphagia, Blood potassium decreased, Death, Discomfort, Hypertension
Clinical narrative: My mother began feeling achy, very uncomfortable, unable to eat. By Thursday she was hospitalized with uncontrollable high blood pressure and a potassium level of 2.9. This was precipitated by the DTAP vaccine given by Dr.
Age: 87.0
Sex: F
Vaccine: TDAP
Symptoms: Pain
Clinical narrative: My mother began feeling achy, very uncomfortable, unable to eat. By Thursday she was hospitalized with uncontrollable high blood pressure and a potassium level of 2.9. This was precipitated by the DTAP vaccine given by Dr.
Age: 31.0
Sex: F
Vaccine: MMR
Symptoms: Malaise, Myalgia, Pain, Pruritus, Pyrexia
Clinical narrative: 5/20/14  - MALAISE, 5/21/14 - FEVER, 5/24/14 - ITCHY SPOTS, STINGY, SORE MUSCLE IN LEGS (COMES & GOES).
Age: 1.79
Sex: M
Vaccine: HEPA, MMR
Symptoms: Aphasia, C-reactive protein increased, CSF white blood cell count increased, Computerised tomogram abnormal, Drooling
Clinical narrative: Irritability and fussiness in AM. Fever mid-morning. PM - right sided facial drooping, inability to swallow, copious drooling, hemiparesis, and inability to speak.
Age: 1.79
Sex: M
Vaccine: HEPA, MMR
Symptoms: Dysphagia, Hemiparesis, Irritability, Nuclear magnetic resonance imaging abnormal, Pyrexia
Clinical narrative: Irritability and fussiness in AM. Fever mid-morning. PM - right sided facial drooping, inability to swallow, copious drooling, hemiparesis, and inability to speak.
Age: 1.79
Sex: M
Vaccine: HEPA, MMR
Symptoms: VIIth nerve paralysis
Clinical narrative: Irritability and fussiness in AM. Fever mid-morning. PM - right sided facial drooping, inability to swallow, copious drooling, hemiparesis, and inability to speak.
Age: 17.0
Sex: M
Vaccine: MMR
Symptoms: Lymphadenopathy, Pyrexia, Sensory disturbance
Clinical narrative: FEVER, SWOLLEN LYMPH NODES, NOT FEELING.
Age: 33.0
Sex: F
Vaccine: MMR
Symptoms: Diarrhoea, Dizziness, Eye pain, Oropharyngeal pain
Clinical narrative: ACHY, EYES, SORE THROAT, DIZZINESS, DIARRHEA.
Age: 60.0
Sex: F
Vaccine: VARZOS
Symptoms: Condition aggravated, Genital herpes
Clinical narrative: I have genital herpes, about this time of the day, I began to have symptoms of an "outbreak".  I called the pharmacy to ask if I could take my medicine (Famvir) and she said "no" - it would interfere with the shingles vaccine.
Age: 4.0
Sex: M
Vaccine: MMRV
Symptoms: Erythema, Local swelling, Skin warm
Clinical narrative: PARENT CONTACTED THE ON-CALL DOCTOR AND MET HIM AT THE HOSPITAL WHILE HE WAS DOING ROUNDS. PT PRESENTED WITH SWELLING FROM MID-ARM TO ELBOW, REDNESS AND HEAT. THE DOCTOR PRESCRIBED KEFLEX AND ORAPRED.
Age: 29.0
Sex: M
Vaccine: TDAP
Symptoms: Alanine aminotransferase increased, Aspartate aminotransferase increased, Blood creatine phosphokinase increased, Erythema, Gait disturbance
Clinical narrative: She states that following that, she had swelling of the left arm.  She also developed an axillary lymphadenopathy on the left side, pain, and redness.  She also had flu-like symptoms.  About 3 days later, she started to have cramps in the legs.  Initially they were mild, but around Wednesday or Thursday of this week, the leg pain became significant.  She had stiffness of the calves and she had had difficulty walking.  She still came to work on Thursday, but because of worsening symptoms, she went to the emergency department.  She was evaluated and was found to have an elevated CPK of 14,000.  She was admitted for further evaluation and management.
Age: 29.0
Sex: M
Vaccine: TDAP
Symptoms: Influenza like illness, Local swelling, Lymphadenopathy, Muscle spasms, Musculoskeletal stiffness
Clinical narrative: She states that following that, she had swelling of the left arm.  She also developed an axillary lymphadenopathy on the left side, pain, and redness.  She also had flu-like symptoms.  About 3 days later, she started to have cramps in the legs.  Initially they were mild, but around Wednesday or Thursday of this week, the leg pain became significant.  She had stiffness of the calves and she had had difficulty walking.  She still came to work on Thursday, but because of worsening symptoms, she went to the emergency department.  She was evaluated and was found to have an elevated CPK of 14,000.  She was admitted for further evaluation and management.
Age: 29.0
Sex: M
Vaccine: TDAP
Symptoms: Pain, Pain in extremity
Clinical narrative: She states that following that, she had swelling of the left arm.  She also developed an axillary lymphadenopathy on the left side, pain, and redness.  She also had flu-like symptoms.  About 3 days later, she started to have cramps in the legs.  Initially they were mild, but around Wednesday or Thursday of this week, the leg pain became significant.  She had stiffness of the calves and she had had difficulty walking.  She still came to work on Thursday, but because of worsening symptoms, she went to the emergency department.  She was evaluated and was found to have an elevated CPK of 14,000.  She was admitted for further evaluation and management.
Age: 1.5
Sex: F
Vaccine: MMR
Symptoms: Pyrexia, Rash generalised
Clinical narrative: FEVER 105, RASH AROUND FACE THAT SPREAD OVER BODY.
Age: 26.0
Sex: M
Vaccine: MMR
Symptoms: Pain, Pyrexia
Clinical narrative: ACHY ALL OVER, LOW GRADE FEVER.
Age: 24.0
Sex: M
Vaccine: MMR
Symptoms: Body temperature increased, Malaise, Musculoskeletal stiffness, Rash
Clinical narrative: 5/18/14-STIFF NECK, MALAISE; 5/20/14-RASH BEGAN ON CHEST; 5/27/14-RASH PERSISTS AND TEMP: 99.6, FEW WHITE SPOTS IN MOUTH.
Age: 1.48
Sex: F
Vaccine: DTAPHEPBIP, FLU3, MMR, VARCEL
Symptoms: Pyrexia, Rash generalised, Rash maculo-papular, Skin lesion, Varicella post vaccine
Clinical narrative: Certain varicella diagnosis at Hospital. Symptoms: fever, generalized (face, scalp, trunk, extremities) macular papular rash, unknown number of lesions.
Age: 66.0
Sex: F
Vaccine: FLUX
Symptoms: Abasia, Asthenia, Blindness transient, Blood test, Chest X-ray
Clinical narrative: This consumer report (initial receipt 20-May-2014) concerns a 66 year old female patient who had no pertinent medical history. Concomitant medications included propranolol and lisinopril and other unspecified medications. In October or November 2013, the patient received a influenza virus vaccine (manufacturer and batch number not provided) as it was the recommendation of the doctor. Two to three months after getting the shot, the patient developed a rash which was diagnosed as hives and skin dermatitis. She then developed heel spurs. After that, she experienced blind spots in her vision and went blind for one or two days. She was seen by an eye specialist. She then could not walk and was extremely weak. She was seen at the hospital and was diagnosed with pneumonia. She was not kept overnight. She then felt as if she had shingles but had not been diagnosed with that condition. Laboratory diagnostics included CAT scan (Computed Axial Tomography), blood work and a lung X-ray. Treatment included steroids and cephalexin. Outcome was not recovered.
Age: 66.0
Sex: F
Vaccine: FLUX
Symptoms: Computerised tomogram, Dermatitis, Exostosis, Herpes zoster, Pneumonia
Clinical narrative: This consumer report (initial receipt 20-May-2014) concerns a 66 year old female patient who had no pertinent medical history. Concomitant medications included propranolol and lisinopril and other unspecified medications. In October or November 2013, the patient received a influenza virus vaccine (manufacturer and batch number not provided) as it was the recommendation of the doctor. Two to three months after getting the shot, the patient developed a rash which was diagnosed as hives and skin dermatitis. She then developed heel spurs. After that, she experienced blind spots in her vision and went blind for one or two days. She was seen by an eye specialist. She then could not walk and was extremely weak. She was seen at the hospital and was diagnosed with pneumonia. She was not kept overnight. She then felt as if she had shingles but had not been diagnosed with that condition. Laboratory diagnostics included CAT scan (Computed Axial Tomography), blood work and a lung X-ray. Treatment included steroids and cephalexin. Outcome was not recovered.
Age: 66.0
Sex: F
Vaccine: FLUX
Symptoms: Rash, Scotoma, Urticaria, X-ray
Clinical narrative: This consumer report (initial receipt 20-May-2014) concerns a 66 year old female patient who had no pertinent medical history. Concomitant medications included propranolol and lisinopril and other unspecified medications. In October or November 2013, the patient received a influenza virus vaccine (manufacturer and batch number not provided) as it was the recommendation of the doctor. Two to three months after getting the shot, the patient developed a rash which was diagnosed as hives and skin dermatitis. She then developed heel spurs. After that, she experienced blind spots in her vision and went blind for one or two days. She was seen by an eye specialist. She then could not walk and was extremely weak. She was seen at the hospital and was diagnosed with pneumonia. She was not kept overnight. She then felt as if she had shingles but had not been diagnosed with that condition. Laboratory diagnostics included CAT scan (Computed Axial Tomography), blood work and a lung X-ray. Treatment included steroids and cephalexin. Outcome was not recovered.
Age: 80.0
Sex: F
Vaccine: FLU3
Symptoms: Abasia, Immunoglobulin therapy, Lumbar puncture, Pain in extremity
Clinical narrative: First symptoms was not able to walk. had only treatment at hospital IV-IG. Went back to rehab until 1-4-14. Came home and have continuous pain in hands, legs and feet.
Age: 9.0
Sex: F
Vaccine: MMR
Symptoms: Pyrexia
Clinical narrative: STARTED WITH FEVER: 101.3 (HIGHEST).
Age: 17.0
Sex: F
Vaccine: HPV4, HPV4
Symptoms: Convulsion, Immediate post-injection reaction
Clinical narrative: Within a few seconds of the Gardasil vaccination, she had a seizure.  Nurses turned her on her side and symptoms resolved in about 1 minute.
Age: 17.0
Sex: F
Vaccine: HPV4, HPV4
Symptoms: Convulsion, Fatigue, Immediate post-injection reaction, Nausea
Clinical narrative: Within a few seconds of the Gardasil vaccination, she had a seizure.  Nurses turned her on her side and symptoms resolved in about 1 minute.
Age: 62.0
Sex: F
Vaccine: VARZOS
Symptoms: Arthralgia, Diarrhoea, Pyrexia
Clinical narrative: Diarrhea started around 9:30 and then I got a fever around 11:00 on the 11 and it lasted through the following Tuesday, May 13. I also was very achy throughout my joints. The fever left during the night on that Tuesday. But the achiness lasted for about another week.
Age: 1.58
Sex: M
Vaccine: DTAP, HEPA, HIBV
Symptoms: Injection site reaction, Rash, Rash erythematous
Clinical narrative: Flat red rash on right arm and leg.
Age: 11.0
Sex: M
Vaccine: HPV4, MNQ, TDAP
Symptoms: Grand mal convulsion, Pallor
Clinical narrative: Brief tonic clonic seizure activity lasting for seconds. Pallor lasting about 30 seconds.
Age: 20.0
Sex: F
Vaccine: MNQ
Symptoms: Expired drug administered, No adverse event
Clinical narrative: Vaccine given on 5/27/14 had expired on 5/14/14.  No adverse events noted.  Patient re-vaccinated the same day.
Age: 1.32
Sex: M
Vaccine: DTAP, HEPA, HIBV, MMR, PNC13, VARCEL
Symptoms: Convulsion, Measles antibody negative, Pyrexia, Rash generalised, Rubella antibody negative
Clinical narrative: Patient began running a 104-105 fever on 5/16 and then had a seizure on 5/16 which required a trip to the ER. The ER physician states that he had a seizure and after being monitored, patient was sent home. On Sunday 5/18 the boy was still running high temperatures (103-104) and started breaking out in a rash from head to toe.
Age: 4.0
Sex: M
Vaccine: DTAPIPV, MMRV, PNC13
Symptoms: Blood culture, C-reactive protein, Differential white blood cell count, Full blood count, Injection site movement impairment
Clinical narrative: Warmth swelling up to waist and down to knee on right side.  Right femur tight/swollen and pruritic.  He was given Benadryl 18.25mg was given orally.
Age: 4.0
Sex: M
Vaccine: DTAPIPV, MMRV, PNC13
Symptoms: Injection site pruritus, Injection site swelling, Injection site warmth, Metabolic function test, Skin warm
Clinical narrative: Warmth swelling up to waist and down to knee on right side.  Right femur tight/swollen and pruritic.  He was given Benadryl 18.25mg was given orally.
Age: 4.0
Sex: M
Vaccine: DTAPIPV, MMRV, PNC13
Symptoms: Swelling
Clinical narrative: Warmth swelling up to waist and down to knee on right side.  Right femur tight/swollen and pruritic.  He was given Benadryl 18.25mg was given orally.
Age: 58.0
Sex: M
Vaccine: HEP, HEPA
Symptoms: Chills, Cough, Dizziness, Hepatic enzyme abnormal, Liver disorder
Clinical narrative: Chills, Night Sweats, Hives. Fever, Cough, Dizziness, Itching, Liver Problems.
Age: 58.0
Sex: M
Vaccine: HEP, HEPA
Symptoms: Night sweats, Pruritus, Pyrexia, Urticaria
Clinical narrative: Chills, Night Sweats, Hives. Fever, Cough, Dizziness, Itching, Liver Problems.
Age: 61.0
Sex: M
Vaccine: VARZOS
Symptoms: Herpes zoster
Clinical narrative: This spontaneous report as received from a patient's wife refers to a 66 year old (at the time of the report) male patient. The reporter stated that on an unknown date in 2009 (reported as "when he was 61 years old") the patient was vaccinated with ZOSTAVAX (lot#, expiration date, dose not reported). No concomitant medications were reported. On an unknown date in 2011 (reported as "when he was 63") the patient developed a case of shingles. The reporter stated that the case of shingles her husband had lasted 6 weeks. The outcome of developed a case of shingles was reported as recovered/resolved. The relatedness between shingles and ZOSTAVAX was not reported. Additional information has been requested.
Age: 69.0
Sex: F
Vaccine: PPV
Symptoms: Cyanosis, Feeling cold, Injection site erythema, Injection site swelling, Injection site warmth
Clinical narrative: Pt had PNEUMOVAX 5-22-14 approx 8 AM. Pt went to the gym and at 8 PM she was feeling very ill and cold. She went to bed and woke up at 11:30 feeling better but (L) upper arm was swollen, red and hot. She noticed 2 fingers (L) hand were blue. She iced her arm and took BENADRYL. 5/23 Fingers normal color. Injection site better but front and back of arm swollen over wkend. 5/26 All redness gone but arm sore with some swelling.
Age: 69.0
Sex: F
Vaccine: PPV
Symptoms: Malaise, Pain in extremity
Clinical narrative: Pt had PNEUMOVAX 5-22-14 approx 8 AM. Pt went to the gym and at 8 PM she was feeling very ill and cold. She went to bed and woke up at 11:30 feeling better but (L) upper arm was swollen, red and hot. She noticed 2 fingers (L) hand were blue. She iced her arm and took BENADRYL. 5/23 Fingers normal color. Injection site better but front and back of arm swollen over wkend. 5/26 All redness gone but arm sore with some swelling.
Sex: U
Vaccine: PPV
Symptoms: Expired drug administered, No adverse event
Clinical narrative: This spontaneous report as received from a nurse refers to a patient of unknown age. The patient's pertinent medical history was not reported. On 22-MAY-2014 the patient was vaccinated with PNEUMOVAX 23 (25 microgram (MCG)/0.5 milliliter (ML) 1 standard package vial of 2.5) intramuscularly. Concomitant medications were not reported. The patient was inadvertently given PNEUMOVAX 23 which was expired on 15-FEB-2014 and lot number was unspecified. No adverse effects noted. The outcome of gave PNEUMOVAX 23 which was expired and no adverse effects noted was unknown. Additional information has been requested.
Age: 42.0
Sex: M
Vaccine: MMR
Symptoms: Expired drug administered, No adverse event
Clinical narrative: This spontaneous report was received from a nurse, concerning a 42 year old male patient. Medical history and concurrent conditions were not reported. On 16-MAY-2014, the patient was vaccinated with a dose M-M-R II (strength was not reported) lot # H009781, expiration date reported as 15-MAY-2014, 0.5 ml, subcutaneous route. Co-suspect and concomitant therapies were not reported. The nurse reported that on 16-MAY-2014, patient received an expired dose of M-M-R II. No adverse effect was reported. Additional information has been requested.
Age: 69.0
Sex: M
Vaccine: PPV
Symptoms: Axillary pain, Cellulitis, Erythema, Herpes zoster, Injection site erythema
Clinical narrative: This spontaneous report was received from a physician via a office manager and refers to a 69 years old male patient. Patient's medical history included: shoulder pain and allergy to LEVAQUIN. On 06-MAY-2014 the patient was vaccinated with PNEUMOVAX 23 (lot # K004207, expiry date: 13-MAY-2015) intramuscularly. Concomitant therapies included acetaminophen, NORCO (indication unknown). On 08-MAY-2014 the patient seeked the medical attention, he came to the office and presented with soreness, redness, pain with extension to the armpit from the injection site. The physician diagnosed this finding as cellulitis, although it looked like "early shingles". Physician treated patient with a seven day regimen of KEFLEX. No laboratory test was performed. The outcome of the event was unknown. The relationship between the PNEUMOVAX 23 and the event was not provided. Additional information has been requested.