chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 60.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site erythema, Injection site induration, Injection site pain, Injection site warmth
Clinical narrative: 03/19/14 Patient experienced warm, red, sore area of inoculation. Hard in center. Called me and called PCP. PCP advised to take BENADRYL 50 mg. Better today 3/20 - redness subsiding, less sore.
Age: 62.0
Sex: F
Vaccine: VARZOS
Symptoms: Erythema, Injection site induration, Local swelling
Clinical narrative: Sx's started a few hours after injection. Pt states arm became very red and swelled up and became hard at the site of injection.
Age: 9.0
Sex: F
Vaccine: TYP
Symptoms: Abdominal pain upper, Dizziness, Ear congestion, Fatigue, Headache
Clinical narrative: Client reported to parent at 5 am 3/19/14 c/o dizzy, stomach pain, plugged ears, sore throat, fever. Parent reports fever 101 degrees orally, child slept all day - extreme fatigue. 3/20/14 fever 100 degrees, continue c/o sore throat and HA. Request advice. Recommend evaluation by MD. Discontinue oral typhoid, RTC after s/s resolve for immunization with TYPHIM Vi. T/C to Crucell, cust service- agrees with this plan. Dad, in agreement with this plan.
Age: 9.0
Sex: F
Vaccine: TYP
Symptoms: Oropharyngeal pain, Pyrexia
Clinical narrative: Client reported to parent at 5 am 3/19/14 c/o dizzy, stomach pain, plugged ears, sore throat, fever. Parent reports fever 101 degrees orally, child slept all day - extreme fatigue. 3/20/14 fever 100 degrees, continue c/o sore throat and HA. Request advice. Recommend evaluation by MD. Discontinue oral typhoid, RTC after s/s resolve for immunization with TYPHIM Vi. T/C to Crucell, cust service- agrees with this plan. Dad, in agreement with this plan.
Age: 45.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site erythema, Injection site pain, Injection site swelling
Clinical narrative: 2" diameter swelling, erythema and pain at site of injection evening after day of injection.
Age: 1.09
Sex: M
Vaccine: HEPA, HIBV, MMR, PNC13, VARCEL
Symptoms: Injection site erythema, Injection site reaction, Injection site swelling, Purulence, Pyrexia
Clinical narrative: On 3/14/14 (per M.O.C.) developed red raised areas to left thigh that became purulent (no drainage) accompanied by non-draining red dots to bilat. legs and stomach. Fever 3/16/14.
Age: 1.09
Sex: M
Vaccine: HEPA, HIBV, MMR, PNC13, VARCEL
Symptoms: Rash, Rash erythematous
Clinical narrative: On 3/14/14 (per M.O.C.) developed red raised areas to left thigh that became purulent (no drainage) accompanied by non-draining red dots to bilat. legs and stomach. Fever 3/16/14.
Age: 25.0
Sex: M
Vaccine: HPV4
Symptoms: Convulsion, Fall, Loss of consciousness, Unresponsive to stimuli
Clinical narrative: I gave the GARDASIL shot, asked patient to sit down for fifteen minutes. Noticed he looked passed out and started convulsing. Did not respond to me I gave him an epinephrine pen. He responded afterwards. He fell from his chair. Call 911. Ambulance came, I walked him out.
Age: 4.0
Sex: M
Vaccine: DTAP, IPV, MMR, VARCEL
Symptoms: Erythema, Pruritus
Clinical narrative: Parent noted symptoms around dinner time on 3/19/2014. Redness and itching noted. Area noted pink and itchy on 03/20/14. No increase in area size noted per parent.
Age: 73.0
Sex: F
Vaccine: VARZOS
Symptoms: Pruritus, Rash
Clinical narrative: Localized itcihng shortly after injection. Mild rash presented later.
Age: 31.0
Sex: F
Vaccine: HEPAB, TDAP, TYP
Symptoms: Local swelling, Pain, Pruritus
Clinical narrative: Hand swelling on 3/17/14 and swelling to mid-arm. Painful and itching.
Age: 86.0
Sex: F
Vaccine: TDAP
Symptoms: Injection site discolouration, Injection site erythema, Injection site rash, Injection site warmth, Pruritus
Clinical narrative: Patient presented to pharmacist with 8" by 4" red rash at injection site. Rash was not raised or swollen but was warm to the touch, had some deep red/purple areas at edges, and patient complained of itching. Recommended BENADRYL, Lidocaine spray and pt to mark borders and check with MD if no improvement in 12 hrs.
Age: 69.0
Sex: F
Vaccine: FLU3
Symptoms: Chapped lips, Dry skin, Lip dry, Lip swelling, Skin fissures
Clinical narrative: Swelling of the lips, and parts of the area around the mouth. Still experiencing dry, chapped skin around the lips and mouth. Went to physician and dermatologist but still has symptoms from January. Already took steroid pack. Has an appointment with allergist next week.
Age: 12.0
Sex: F
Vaccine: HPV4
Symptoms: Alopecia
Clinical narrative: This spontaneous report as received from a consumer, mother of the patient, refers a 12 year old female patient. On an unknown date (also reported as "couple of months ago"), the patient was vaccinated with the first dose of GARDASIL route reported as injection. On 17-MAR-2014, the patient had a two inch diameter bald spot on her head. No treatment was given for the adverse event. No lab diagnostics were performed. The patient did not see any medical attention. The outcome of the patient had a two inch diameter bald spot on her head was reported as not recovered/not resolved. Additional information has been requested.
Sex: U
Vaccine: HPV4
Symptoms: Incorrect storage of drug, No adverse event
Clinical narrative: This spontaneous report as received from a registered nurse refers to a patient of unknown age. On 17-MAR-2014, the patient was vaccinated with GARDASIL (lot # J010668, expiration date 29-APR-2016) 0.5 ml, intramuscular. Dose underwent temperature excursion and was exposed to 60F for 24 hours (supported). No adverse effects reported. This is one of several reports from the same source. Additional information has been requested.
Sex: U
Vaccine: PPV
Symptoms: Expired drug administered, No adverse event
Clinical narrative: This spontaneous report as received from a Licensed Practical Nurse refers to a patient of unknown demographics. The patient's current conditions or medical history were not reported. On 17-MAR-2014 the patient was vaccinated with a dose of PNEUMOVAX 23 vial, intramuscular, 0.5 ml expiry date 11-MAR-2014 (lot number was not reported). No adverse effect reported. Additional information is not expected.
Age: 67.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site pruritus, Injection site warmth
Clinical narrative: This spontaneous report as received from a registered pharmacist refers to a 67 year old female patient with no pertinent medical history and no drug reactions or allergies. On 11-MAR-2014, the patient was vaccinated with a single dose of ZOSTAVAX (Lot # reported as J013133, expiration date 17-JAN-2015) subcutaneously in the left arm. There was no concomitant medication. The pharmacist reported that on an unknown date in March 2014, the patient developed a 2-3 inch round area of warmth and itchiness at the injection site after administration of ZOSTAVAX. The patient did not received treatment for the adverse events. There were no Lab diagnosis or studies performed. The outcome of 2-3 inch round area of warmth and itchiness at the injection site was reported as recovering/resolving. Additional information is not expected.
Sex: U
Vaccine: PPV
Symptoms: Expired drug administered, No adverse event
Clinical narrative: This spontaneous report as received from a pharmacist (Pharm. D.) refers to a patient of unknown age and gender. On 25-FEB-2014 the patient was vaccinated with a dose of PNEUMOVAX 23, 0.5 ml, intramuscular, lot# H009826, expiry date 11-FEB-2014. The patient was inadvertently administered the expired dose of PNEUMOVAX 23. No adverse effects reported. Additional information is not expected.
Sex: U
Vaccine: PPV
Symptoms: Incorrect storage of drug, No adverse event
Clinical narrative: This spontaneous report as received from a registered nurse refers to a patient of unknown age. On 17-MAR-2014, the patient was vaccinated with PNEUMOVAX 23 (lot # J014399, expiration date 20-NOV-2014) 0.5 ml, intramuscular. Dose underwent temperature excursion and was exposed to 60F for 24 hours (supported). No adverse effects reported. This is one of several reports from the same source. Additional information has been requested.
Sex: U
Vaccine: HEP
Symptoms: Incorrect storage of drug, No adverse event
Clinical narrative: This spontaneous report as received from a registered nurse refers to a patient of unknown age. On 17-MAR-2014 the patient was vaccinated with RECOMBIVAX HB (lot # J005575, expiration date 16-DEC-2015) 1 ml, intramuscular. Dose underwent temperature excursion and was exposed to 60F for 24 hours (supported). No adverse effects reported. This is one of several reports from the same source. Additional information has been requested.
Age: 11.0
Sex: M
Vaccine: FLU3
Symptoms: Concussion, Fall, Head injury, Headache, Swelling face
Clinical narrative: Case number PHHY2013US000453 is an initial spontaneous report received from vaccine adverse event reporting system (VAERS reference number: 471935) on 02 Jan 2013, with a follow up received from Quality Assurance Department (QA, reference number: 209076) on 18 Mar 2014. This report refers to an 11-year-old male patient. The patient was vaccinated with FLUVIRIN (batch number: 1204521) intramuscularly in right arm on 29 Oct 2012. On 29 Oct 2012, shortly after the vaccination, he fell to floor resulting and developed a bump on the side of forehead. He was conscious the entire time answering all questions being asked. An ice pack was placed on the bumpy immediately. The swelling went down before he was pushed in motor chair to car. He also had some water. He stated that his head hurt. The patient's parents took him to visit doctor right away. The physician stated that he had a concussion and prescribed TYLENOL and asked him to refrain from sports that week, but also mentioned that he would be ok. He also had a fainting episode due to possibly watching brother get vaccine administered. The patient went to emergency room for the events. The outcome of the events was reported as completely recovered as of 29 Oct 2012. The seriousness and causality of the events was not reported. Based on the investigation performed, the QA department stated that, FLUVIRIN (batch number: 1204521) 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: 209076) on 18 Mar 2014: Updated batch review report.
Age: 11.0
Sex: M
Vaccine: FLU3
Symptoms: Syncope
Clinical narrative: Case number PHHY2013US000453 is an initial spontaneous report received from vaccine adverse event reporting system (VAERS reference number: 471935) on 02 Jan 2013, with a follow up received from Quality Assurance Department (QA, reference number: 209076) on 18 Mar 2014. This report refers to an 11-year-old male patient. The patient was vaccinated with FLUVIRIN (batch number: 1204521) intramuscularly in right arm on 29 Oct 2012. On 29 Oct 2012, shortly after the vaccination, he fell to floor resulting and developed a bump on the side of forehead. He was conscious the entire time answering all questions being asked. An ice pack was placed on the bumpy immediately. The swelling went down before he was pushed in motor chair to car. He also had some water. He stated that his head hurt. The patient's parents took him to visit doctor right away. The physician stated that he had a concussion and prescribed TYLENOL and asked him to refrain from sports that week, but also mentioned that he would be ok. He also had a fainting episode due to possibly watching brother get vaccine administered. The patient went to emergency room for the events. The outcome of the events was reported as completely recovered as of 29 Oct 2012. The seriousness and causality of the events was not reported. Based on the investigation performed, the QA department stated that, FLUVIRIN (batch number: 1204521) 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: 209076) on 18 Mar 2014: Updated batch review report.
Age: 63.0
Sex: F
Vaccine: FLU3
Symptoms: Lip swelling, Local swelling
Clinical narrative: Case number PHHY2013US000511, is an initial report received from the Vaccine Adverse Event Reporting System (VAERS reference number: 472035) website on 02 Jan 2013, with the follow-up received from Quality Assurance Department (reference number: 209083) on 18 Mar 2014: This report refers to a 63-years-old female patient. Her medical history and concomitant medication were not reported. She was vaccinated with FLUVIRIN (batch number: 1204201) intramuscularly in the arm on 26 Oct 2012. On 27 Oct 2012 at 4:00 PM, she experienced swollen lips, puffy fingers and possible swollen tongue. The outcome of the events was reported as condition unchanged as of 27 Oct 2012. The causality and seriousness of the events was not reported. Based on the investigation performed, QA department stated that, the FLUVIRIN (batch number: 1204201) was manufactured in accordance with the approved internal procedures and it is in compliance with the cGMP requirements. Follow-up received from Quality Assurance Department (reference number: 209083) on 18 Mar 2014: Updated batch review report.
Age: 10.0
Sex: F
Vaccine: FLU3
Symptoms: Convulsion, Gaze palsy, Immediate post-injection reaction, Loss of consciousness, Posture abnormal
Clinical narrative: Case number PHHY2013US012165 is an initial spontaneous report from Vaccine Adverse Event Reporting System (VAERS reference 474643) received on 08 Feb 2013 with a follow up report received from the quality assurance department (QA reference number: 210548) on 18 Mar 2014. This report refers to a 10-year-old female patient. Her medical history and concomitant medications were not reported. She was vaccinated with FLUVIRIN (batch number 1204201) intramuscularly in her right arm on 17 Nov 2012. On 17 Nov 2012, the same day immediately after vaccination her eyes rolled backward, she slumped in chair and had convulsions. About 20 seconds later, she regained consciousness. Following these events she visited emergency room. The outcome of the events was reported as complete recovery as of 17 Nov 2012. The seriousness and causality assessment of the events was not reported. Based on the review performed, this product batch was manufactured in accordance with the approved internal procedures and was in compliance with the cGMP requirements. Follow up received from the quality assurance department (QA reference number: 210548) on 18 Mar 2014: The batch review report was updated.
Age: 21.0
Sex: F
Vaccine: FLU3
Symptoms: Fall, Head injury, Headache, Musculoskeletal pain, Syncope
Clinical narrative: Case number PHHY2013US012003, is an initial spontaneous report received from the Vaccine Adverse Event Reporting System (VAERS reference number: 474817) website on 08 Feb 2013 with a follow up report received from the quality assurance department (QA reference number: 210495) on 18 Mar 2014. This report refers to a 21 year old female patient. Her medical history and concomitant medications were not reported. She was vaccinated with FLUVIRIN (batch number: 1206301) into left arm on 16 Nov 2012. About, five minutes after vaccination, she fainted and fell backwards hitting her bottom and her head on the ground. She became normal within seconds and left the pharmacy 20 minutes later and her head was hurt. On 17 Nov 2012, she complained of a sore rear and intermittent headaches. The outcome of the events was reported as recovered as of an unspecified date. The event seriousness and causality was not reported. Based on the review performed, this product batch (batch number: 1206301) was manufactured in accordance with the approved internal procedures and was in compliance with the cGMP requirements. Follow up report was received from the quality assurance department (QA reference number: 210495) on 18 Mar 2014: The batch review was updated.
Age: 34.0
Sex: M
Vaccine: FLU3
Symptoms: Pain, Pain in extremity, Rotator cuff syndrome
Clinical narrative: Case number PHHY2013US012191, is an initial spontaneous report received from the Vaccine Adverse Event Reporting System (VAERS reference number: 475707) website on 08 Feb 2013 with a follow up report received from the quality assurance department (QA reference number: 215603) on 18 Mar 2014. This report refers to a 34-year-old male patient. His medical history was not reported. His concomitant medication included omeprazole. He was vaccinated with FLUVIRIN (batch number: 1206301) intramuscularly into left arm on 31 Oct 2012. On 01 Nov 2012, he had pain, even movement of arm. Pain still existed as of 25 Nov 2012, but only with movement. He had emergency visit to the hospital and consulted the physician, who believed it was tendinitis of rotator cuff. he was told to use ice and ibuprofen and return to hospital if he did not have relief. The outcome of the events was reported as not recovered as of 28 Nov 2012. The event seriousness and causality were not reported. Based on the review performed, this product batch (batch number: 1206301) was manufactured in accordance with the approved internal procedures and was in compliance with the cGMP requirements. Follow up report was received from the quality assurance department (QA reference number: 215603) on 18 Mar 2014: The batch review report was updated.
Age: 55.0
Sex: F
Vaccine: FLU3
Symptoms: Body temperature increased, Cough, Dyspnoea, Heart rate increased, Wheezing
Clinical narrative: Case number PHHY2013US012217, is an initial spontaneous report received from the Vaccine Adverse Event Reporting System (VAERS reference number: 475883) website on 08 Feb 2013, with the follow-up received from Quality Assurance Department (reference number: 210424) on 18 Mar 2014. This report refers to a 55-year-old female patient. Her medical history included allergic to eggs, milk, hydrocodone, condine, corn, environment and banana. This polymedicated patient was vaccinated with FLUVIRIN (batch number: 1204201) into left arm on 29 Nov 2012. On the same day, after vaccination, she experienced coughing, rapid heartbeat about 180, temperature approximately 99 and more, wheezing, and difficulty breathing. The reporter assessed the case as serious (life threatening). The outcome of the events was reported as recovered. The causality of the events was not reported. Based on the investigation performed, QA department stated that, the FLUVIRIN (batch number: 1204201) was manufactured in accordance with the approved internal procedures and it is in compliance with the cGMP requirements. Follow-up received from Quality Assurance Department (reference number: 210424) on 18 Mar 2014: Updated batch review report.
Age: 69.0
Sex: M
Vaccine: FLU3
Symptoms: Eye swelling, Laboratory test normal, Reaction to preservatives, Swelling face
Clinical narrative: Case number PHHY2013US012261, is an initial spontaneous report received from Vaccine Adverse Event Reporting System (VAERS reference number: 476941) web site on 08 Feb 2013 with a follow up report received from the quality assurance department (QA reference number: 215594) on 18 Mar 2014. This report refers to 69 year old male patient. His medical history and concomitant medication was not reported. He was vaccinated with FLUVIRIN (batch number: 1206301) IM into left arm on 04 Dec 2012 at 9 am. Patient began to experience swelling of face, eyes and cheeks around 1:30 AM on 05 Dec 2012. He visited the ER. MD prescribed prednisone and felt allergy was to thimerosal. Lab test was done (unspecified) and it was negative. Outcome of the event was complete recovery. Seriousness and causality of the event was not reported. Based on the review performed, this product batch (batch number: 1206301) was manufactured in accordance with the approved internal procedures and was in compliance with the cGMP requirements. Follow up report was received from the quality assurance department (QA reference number: 215594) on 18 Mar 2014: The batch review report was updated.
Age: 21.0
Sex: F
Vaccine: FLU3
Symptoms: Convulsion, Hyperhidrosis, Staring
Clinical narrative: Case number PHHY2013US032664 is an initial spontaneous report received from the Vaccine Adverse Event Reporting System (VAERS reference number: 481999) website on 04 Apr 2013 with a follow up report received from quality assurance department (QA reference number: 221533) on 18 Mar 2014. This report refers to a 21 year old female patient. She was vaccinated with FLUVIRIN (batch number: 1206301) on 20 Jan 2013 intramuscularly. On the same date, 2 minutes after vaccination, the patient got sweaty, her eyes went blank and she appeared to have a minor seizure. She felt better after a few minutes. She visited the emergency room. The outcome of the events was reported as complete recovery on 20 Jan 2013. The seriousness and causality of the events were not reported. Based on the batch review performed, it was concluded that FLUVIRIN batch number: 1206301 was manufactured in accordance with the approved internal procedures and in compliance with the cGMP requirements. Follow up report received on 18 Mar 2014: Updated batch review report and QA reference number.
Age: 31.0
Sex: F
Vaccine: FLU3
Symptoms: Injected limb mobility decreased, Injection site pain, Injection site swelling, Musculoskeletal pain
Clinical narrative: Case number PHHY2013US032644 is an initial spontaneous report received from the Vaccine Adverse Event Reporting System (VAERS reference number: 483977) website on 04 Apr 2013 with a follow up report received from quality assurance department (QA reference number: 222344) on 18 Mar 2014. This report refers to a 31 year old female patient. She was vaccinated with FLUVIRIN (batch number: 1206301) intramuscularly to left arm on 26 Dec 2012. On the same day after vaccination, she experienced sore shoulder that has progressively gotten worse since her flu shot on 26 Dec 2012. She consulted with her physician. She had also contacted the pharmacy requesting for information regarding the flu shot received on 26 Dec 2012. She said that when she initially received FLUVIRIN she experienced mild soreness in her left shoulder which worsened progressively over the course of the last month. She had a bump near the administration site and it was very difficult to raise her arm. Outcome of the events were reported condition unchanged as of 08 Feb 2013. Seriousness and causality were not reported. Based on the batch review performed, it was concluded that FLUVIRIN batch number: 1206301 was manufactured in accordance with the approved internal procedures and in compliance with the cGMP requirements. Follow up report received on 18 Mar 2014: Updated batch review report and QA reference number.
Age: 14.0
Sex: F
Vaccine: HPV4
Symptoms: Abortion induced, Exposure during pregnancy, Pregnancy test positive, Pregnancy test urine positive
Clinical narrative: This spontaneous prospective pregnancy report was received from a physician refers to a female patient of unknown age. The patient had no pertinent medical history or drug allergies. On 07-DEC-2012, the patient was vaccinated with first dose of GARDASIL (lot # 0477AA, expiry date 29-JUN-2013 given in the left arm). On 25-JUN-2013, the patient was vaccinated with second dose of 0.5 ml GARDASIL (lot # H020901, expiry date 05JUL-2015 given in the left arm). Concomitant therapies included Prenatal vitamins. The patient's last menstrual period was on 28-APR-2013 and Estimated Delivery Date of 02-FEB-2014. On 25-JUN-2013, the patient had blood work done which showed that the patient was pregnant and the urine pregnancy test was positive. The patient sought medical attention. Follow up information was received. Physician reported that on an unspecified date pregnancy was terminated. Upon internal review pregnancy terminated was considered medically significant. Additional information is not expected.
Age: 0.36
Sex: F
Vaccine: DTAPHEPBIP
Symptoms: Crying, Pyrexia, Respiratory tract congestion, Rhinorrhoea
Clinical narrative: Runny nose, congested, fever, cried for at least 2 hours straight.
Age: 70.0
Sex: F
Vaccine: VARCEL
Symptoms: Blood test, Cerebrovascular accident, Injection site erythema, Injection site pain, Pyrexia
Clinical narrative: This spontaneous report as received from a now 77 year old female physician refers to herself. The patient's medical history included sleep apnea, heart failure, history of tuberculosis, the patient had a history of agitation and vomiting after amiodarone use, also had a history of blindness for 4 hours after nitroglycerin (manufacturer unknown) use. Approximately in March 2007 ("7 years ago") the patient was vaccinated with a dose of VARIVAX (merck), lot#, expiration date, dose not reported, intramuscular. Concomitant therapies included CARDIZEM, COUMADIN and ATACAND. On an unknown date after vaccination, the patient developed fever of 102F, and also redness and a little bit of pain at the site of VARIVAX (merck) injection. She recovered 3-4 days later. The patient had 3 separate strokes between about "2-5 years ago". The patient was hospitalized each time. The patient was still recovering from these strokes. Blood tests were performed and no results were provided. Upon internal review, strokes was considered as medically significant. The patient had a history of blindness for 4 hours while on prior therapy with nitroglycerin (manufacturer unknown) (captured in MARRS #1403USA009381). Additional information is not expected.
Age: 62.0
Sex: M
Vaccine: VARZOS, VARZOS, VARZOS
Symptoms: Blood test, Chest X-ray, Cough, Fatigue, Impaired work ability
Clinical narrative: This spontaneous report as received from registered nurse refers to a 62 year old male patient. Patient had elevated cholesterol, impaired fasting glucose. On an unspecified date in past patient experienced muscle pain while using LIPITOR, Fenofibrate, NIASPAN. On 04-MAR-2014 the patient was vaccinated with ZOSTAVAX, (route of administration, dose strength was not reported). Concomitant therapies included LIVALO, meclizine, testosterone undecanoate (manufacturer unknown) and VALIUM. On 05-MAR-2014 (AE onset date also reported as 09-MAR-2014), 2 days after dose administration the patient experienced fatigue (disability), diffuse varicella like rash on the trunk of his body after receiving ZOSTAVAX (disability), fever (disability) and cough (disability). On an unknown date laboratory test conducted was chest x-ray and unspecified blood test with unknown results. Patient sought medical attention. The nurse stated that the patient was unable to work at his job, since 05-MAR-2014 due to these symptoms. The outcome of cough, diffuse varicella like rash on the trunk of his body, fever and fatigue was reported as recovering. The relation between ZOSTAVAX and the event was unknown. Additional information has been requested.
Age: 62.0
Sex: M
Vaccine: VARZOS, VARZOS, VARZOS
Symptoms: Pyrexia, Rash, Rash vesicular
Clinical narrative: This spontaneous report as received from registered nurse refers to a 62 year old male patient. Patient had elevated cholesterol, impaired fasting glucose. On an unspecified date in past patient experienced muscle pain while using LIPITOR, Fenofibrate, NIASPAN. On 04-MAR-2014 the patient was vaccinated with ZOSTAVAX, (route of administration, dose strength was not reported). Concomitant therapies included LIVALO, meclizine, testosterone undecanoate (manufacturer unknown) and VALIUM. On 05-MAR-2014 (AE onset date also reported as 09-MAR-2014), 2 days after dose administration the patient experienced fatigue (disability), diffuse varicella like rash on the trunk of his body after receiving ZOSTAVAX (disability), fever (disability) and cough (disability). On an unknown date laboratory test conducted was chest x-ray and unspecified blood test with unknown results. Patient sought medical attention. The nurse stated that the patient was unable to work at his job, since 05-MAR-2014 due to these symptoms. The outcome of cough, diffuse varicella like rash on the trunk of his body, fever and fatigue was reported as recovering. The relation between ZOSTAVAX and the event was unknown. Additional information has been requested.
Age: 62.0
Sex: M
Vaccine: VARZOS, VARZOS, VARZOS
Symptoms: Asthma, Blood test, Body temperature increased, Computerised tomogram, Malaise
Clinical narrative: This spontaneous report as received from registered nurse refers to a 62 year old male patient. Patient had elevated cholesterol, impaired fasting glucose. On an unspecified date in past patient experienced muscle pain while using LIPITOR, Fenofibrate, NIASPAN. On 04-MAR-2014 the patient was vaccinated with ZOSTAVAX, (route of administration, dose strength was not reported). Concomitant therapies included LIVALO, meclizine, testosterone undecanoate (manufacturer unknown) and VALIUM. On 05-MAR-2014 (AE onset date also reported as 09-MAR-2014), 2 days after dose administration the patient experienced fatigue (disability), diffuse varicella like rash on the trunk of his body after receiving ZOSTAVAX (disability), fever (disability) and cough (disability). On an unknown date laboratory test conducted was chest x-ray and unspecified blood test with unknown results. Patient sought medical attention. The nurse stated that the patient was unable to work at his job, since 05-MAR-2014 due to these symptoms. The outcome of cough, diffuse varicella like rash on the trunk of his body, fever and fatigue was reported as recovering. The relation between ZOSTAVAX and the event was unknown. Additional information has been requested.
Age: 62.0
Sex: M
Vaccine: VARZOS, VARZOS, VARZOS
Symptoms: Obliterative bronchiolitis, Pneumonia, Pulmonary function test, Varicella, X-ray
Clinical narrative: This spontaneous report as received from registered nurse refers to a 62 year old male patient. Patient had elevated cholesterol, impaired fasting glucose. On an unspecified date in past patient experienced muscle pain while using LIPITOR, Fenofibrate, NIASPAN. On 04-MAR-2014 the patient was vaccinated with ZOSTAVAX, (route of administration, dose strength was not reported). Concomitant therapies included LIVALO, meclizine, testosterone undecanoate (manufacturer unknown) and VALIUM. On 05-MAR-2014 (AE onset date also reported as 09-MAR-2014), 2 days after dose administration the patient experienced fatigue (disability), diffuse varicella like rash on the trunk of his body after receiving ZOSTAVAX (disability), fever (disability) and cough (disability). On an unknown date laboratory test conducted was chest x-ray and unspecified blood test with unknown results. Patient sought medical attention. The nurse stated that the patient was unable to work at his job, since 05-MAR-2014 due to these symptoms. The outcome of cough, diffuse varicella like rash on the trunk of his body, fever and fatigue was reported as recovering. The relation between ZOSTAVAX and the event was unknown. Additional information has been requested.
Age: 62.0
Sex: M
Vaccine: VARZOS, VARZOS, VARZOS
Symptoms: Alanine aminotransferase increased, Aspartate aminotransferase increased, Chest X-ray normal, Computerised tomogram normal, Cough
Clinical narrative: This spontaneous report as received from registered nurse refers to a 62 year old male patient. Patient had elevated cholesterol, impaired fasting glucose. On an unspecified date in past patient experienced muscle pain while using LIPITOR, Fenofibrate, NIASPAN. On 04-MAR-2014 the patient was vaccinated with ZOSTAVAX, (route of administration, dose strength was not reported). Concomitant therapies included LIVALO, meclizine, testosterone undecanoate (manufacturer unknown) and VALIUM. On 05-MAR-2014 (AE onset date also reported as 09-MAR-2014), 2 days after dose administration the patient experienced fatigue (disability), diffuse varicella like rash on the trunk of his body after receiving ZOSTAVAX (disability), fever (disability) and cough (disability). On an unknown date laboratory test conducted was chest x-ray and unspecified blood test with unknown results. Patient sought medical attention. The nurse stated that the patient was unable to work at his job, since 05-MAR-2014 due to these symptoms. The outcome of cough, diffuse varicella like rash on the trunk of his body, fever and fatigue was reported as recovering. The relation between ZOSTAVAX and the event was unknown. Additional information has been requested.
Age: 62.0
Sex: M
Vaccine: VARZOS, VARZOS, VARZOS
Symptoms: Full blood count normal, Pyrexia, Rash, Respiratory disorder
Clinical narrative: This spontaneous report as received from registered nurse refers to a 62 year old male patient. Patient had elevated cholesterol, impaired fasting glucose. On an unspecified date in past patient experienced muscle pain while using LIPITOR, Fenofibrate, NIASPAN. On 04-MAR-2014 the patient was vaccinated with ZOSTAVAX, (route of administration, dose strength was not reported). Concomitant therapies included LIVALO, meclizine, testosterone undecanoate (manufacturer unknown) and VALIUM. On 05-MAR-2014 (AE onset date also reported as 09-MAR-2014), 2 days after dose administration the patient experienced fatigue (disability), diffuse varicella like rash on the trunk of his body after receiving ZOSTAVAX (disability), fever (disability) and cough (disability). On an unknown date laboratory test conducted was chest x-ray and unspecified blood test with unknown results. Patient sought medical attention. The nurse stated that the patient was unable to work at his job, since 05-MAR-2014 due to these symptoms. The outcome of cough, diffuse varicella like rash on the trunk of his body, fever and fatigue was reported as recovering. The relation between ZOSTAVAX and the event was unknown. Additional information has been requested.
Age: 0.33
Sex: M
Vaccine: DTAPIPVHIB, PNC13
Symptoms: Death, Respiratory arrest, Status epilepticus
Clinical narrative: Died of status epilepticus and respiratory arrest on 3-21-14.
Sex: U
Vaccine: PPV
Symptoms: Incorrect storage of drug, No adverse event
Clinical narrative: This spontaneous report was received from a registered nurse refers to a patient of unknown age and gender. On 14-MAR-2014 the patient received an improperly stored dose of PNEUMOVAX 23 (lot # J009723, expiry: 30-JAN-2015) single dose vial. No adverse event reported. No PQC involved. Additional information has been requested.
Age: 2.0
Sex: U
Vaccine: HEPA
Symptoms: Drug administered to patient of inappropriate age, No adverse event
Clinical narrative: This spontaneous report as received from a licensed practical nurse refers to a 2 year old patient of unknown gender. In November 2013 the patient was vaccinated with an adult dose of VAQTA, route and lot # unknown. There were no adverse effects reported. Additional information has been requested.
Sex: U
Vaccine: HPV4
Symptoms: Inappropriate schedule of drug administration, No adverse event
Clinical narrative: This spontaneous report as received from a certified medical assistant (CMA) refers to a patient (unspecified gender and age). Approximately on an unknown date in February 2013 (on an unknown date approximately one year ago), the patient was vaccinated with first dose of GARDASIL INJ 120 Y (dose, route and lot number unspecified). No concomitant therapy reported. At the time of the report, the patient would like to receive a second dose of GARDASIL. No adverse symptoms reported. No product quality complaint involved. No further information provided. The outcome of event was unknown. Follow up information was received on 18-MAR-2014. In January 2013, the patient had one dose of GARDASIL (dose, route and lot number unspecified), then discontinued and, in January 2014, a new dose of GARDASIL was administered (dose, route and lot number unspecified). The patient had no reactions or side effects (no adverse event). Additional information is not expected.
Sex: U
Vaccine: HEP
Symptoms: Antibody test negative
Clinical narrative: This spontaneous report as received from a registered nurse via a company representative refers to a patient of unknown age and gender. On an unknown dates the patient was vaccinated with 3 unspecified doses of RECOMBIVAX HB (lot number, expiration date and route not reported). It was reported that in approximately 2014 ("recently") the patient was at the office and was tested for titers which came out negative. The outcome of the event was unknown. The relatedness between the event and RECOMBIVAX HB was not reported. Additional information is not expected.
Sex: U
Vaccine: HPV4, MMR, PPV, VARCEL
Symptoms: Incorrect storage of drug, No adverse event
Clinical narrative: This spontaneous report as received from a registered nurse refers to an unknown number of patients of unknown age. The nurse reported that on an unknown dates unknown number of patients might have been vaccinated with M-M-R II (dose, lot number, expiration date and route of administration not reported). Other suspect therapies included (oka/merck) VARIVAX (dose, lot number, expiration date and route of administration not reported), GARDASIL (dose, lot number, expiration date and route of administration not reported) and PNEUMOVAX23 (dose, lot number, expiration date and route of administration not reported) that had multiple excursions. No adverse effects were reported. The follow-up information has been received from a nurse with the information that an unspecified patient was in the office at the time of the report and was about to be administered (it was not reported whether the patient received the vaccine) A dose of (oka/merck) VARIVAX (dose not reported, lot # J005726 and expiration date: 08-MAY-2015) which was stored outside of recommended temperature range as noted in prescribing information. No adverse effect reported. Additional information has been requested.
Sex: U
Vaccine: HPV4
Symptoms: Incorrect storage of drug, No adverse event
Clinical narrative: This spontaneous report as received from a nurse refers to a patient of unknown age. On an unknown date the patient was vaccinated with GARDASIL (lot number and frequency unknown) (dosing regimen and frequency unknown) which was exposed to temperatures outside the prescribing information. No concomitant medications were reported. No adverse events were reported. The action taken with the therapy with GARDASIL was unknown. This case is linked to case number 1403USA007008 and 1403USA007007. On 19-MAR-2014 a phone call was placed to the Licensed Practical Nurse. The receptionist, transferred the phone call to Licensed Practical Nurse. The Licensed Practical Nurse stated no doses were administered. It was reported that the lot number of GARDASIL was J011272 and expiry date 21-APR-2016. No further information was available at this time. Additional information has been requested.
Sex: F
Vaccine: MMR
Symptoms: Unevaluable event
Clinical narrative: This spontaneous report as received from a pharmacist refers to a pediatric female patient of unknown age with no pertinent medical history and no drug reactions/allergies. On 10-MAR-2014 (reported as one week ago) the patient was vaccinated with a dose of M-M-R II (route, dose and indication not reported). No concomitant medication reported. The pharmacist reported that the pediatric patient who received a dose of M-M-R II last week came to pharmacy and filled prescription for BACTRIM. No lab diagnostics studies were performed. At the time of the report, outcome of the event was not reported. Additional information is not expected.
Sex: U
Vaccine: VARZOS
Symptoms: Incorrect storage of drug, No adverse event
Clinical narrative: This spontaneous report as received from a registered nurse refers to a patient of unknown age and gender. On 03-DEC-2013 the patient was vaccinated with an improperly stored dose of ZOSTAVAX, lot# and expiry date not reported, 0.65 ml, subcutaneous. No symptoms reported. It was not reported if the patient had sought medical attention. Additional information is not expected.
Sex: U
Vaccine: HPV4
Symptoms: Incorrect storage of drug, No adverse event
Clinical narrative: This spontaneous report as received from a public health administrator refers to an unspecified number of patients of unknown age and gender. On an unknown date the patients were vaccinated with GARDASIL (lot number and frequency unknown) (dosing regimen and frequency unknown) that went through a temperature excursion. No concomitant medications were reported. No adverse events were reported. No product quality issue was reported. Additional information has been requested.
Sex: U
Vaccine: VARCEL
Symptoms: Incorrect storage of drug, No adverse event
Clinical narrative: This spontaneous report as received from a healthcare worker refers to multiple unspecified patients of unknown age. On an unknown dates the patients were vaccinated with VARIVAX (Merck) dose, route and lot # not specified. The vaccines went through a supported temperature excursion. No adverse effects were reported. Additional information has been requested.
Sex: F
Vaccine: VARZOS, VARZOS
Symptoms: Condition aggravated, Feeling abnormal, Herpes zoster, Rash erythematous
Clinical narrative: This spontaneous report as received from a consumer refers to a female patient of unknown age. The patient reported that when she was 12 years old she had shingles. On an unspecified date about a year ago approximately in 2013 the patient was vaccinated with ZOSTAVAX (dose strength, daily dose and route was not reported). Patient also reported that she was using 18 other unspecified medications made by the company even at the time when she received ZOSTAVAX and also reported that she was going to tell her doctor that she would rather die than use any other product by the company. Last week approximately in March 2014 the patient developed shingles in the form of a red rash and feel terrible. The outcome of event shingles in the form of a red rash and feel terrible was unknown. The relatedness between the drug and the event was unknown. Additional information has been requested.
Sex: F
Vaccine: VARZOS, VARZOS
Symptoms: Herpes zoster, Injection site reaction
Clinical narrative: This spontaneous report as received from a consumer refers to a female patient of unknown age. The patient reported that when she was 12 years old she had shingles. On an unspecified date about a year ago approximately in 2013 the patient was vaccinated with ZOSTAVAX (dose strength, daily dose and route was not reported). Patient also reported that she was using 18 other unspecified medications made by the company even at the time when she received ZOSTAVAX and also reported that she was going to tell her doctor that she would rather die than use any other product by the company. Last week approximately in March 2014 the patient developed shingles in the form of a red rash and feel terrible. The outcome of event shingles in the form of a red rash and feel terrible was unknown. The relatedness between the drug and the event was unknown. Additional information has been requested.
Age: 43.0
Sex: F
Vaccine: MMR
Symptoms: Expired drug administered, No adverse event
Clinical narrative: This spontaneous report as received from a registered nurse refers to a 43 years old female patient. On an unspecified date, the patient started therapy with M-M-R II (dose, route, lot not reported). On 17-MAR-2014 the patient was vaccinated with the expired, unspecified dose (dose number unknown) of M-M-R II (route not reported, lot # 671685/1873AA and expiration date: 30-NOV-2013). No adverse effect was reported. Additional information has been requested.
Age: 4.0
Sex: M
Vaccine: MMRV
Symptoms: Expired drug administered, No adverse event
Clinical narrative: This spontaneous report as received from a nurse refers to a patient of unknown age and gender. No information regarding the patient's medical history was provided. On 13-MAR-2014 the patient was vaccinated with PROQUAD injection, with valid lot # H015630, which had been expired on 21-FEB-2014. No concomitant medication was reported. No adverse symptoms were reported. No outcome was reported. Additional information has been requested.
Sex: U
Vaccine: HPV4
Symptoms: Inappropriate schedule of drug administration, No adverse event
Clinical narrative: This spontaneous report as received from registered nurse refers to a patient of unknown age and gender. Patient's medical history was unknown. On an unknown date of 2012, patient received first dose injection of GARDASIL (strength, dose unit, route, lot# and expiry date unknown). On 13-DEC-2013, the patient was vaccinated with second dose injection of GARDASIL (strength, dose, unit, route, lot# and expiry date unknown). On 19-MAR-2014 (also reported as today), patient was in office to have the third dose of GARDSIL administer. The nurse reported that GARDASIL doses were administered outside of the PI recommended spacing. No adverse effects were reported. The outcome of doses was administered outside of the pi recommended spacing and no adverse effects is unknown. The reporter considered doses were administer outside of the pi recommended spacing and no adverse effect to be not related to GARDASIL. No further information provided. Additional information has been requested.
Age: 15.0
Sex: F
Vaccine: HEP
Symptoms: Wrong drug administered
Clinical narrative: Reactions none. Pt was given a second dose of Hep B instead of her second dose of HPV.
Age: 47.0
Sex: F
Vaccine: FLUR3
Symptoms: Burning sensation, Headache, Injection site pain, Intervertebral disc degeneration, Local swelling
Clinical narrative: Received egg free flu (FLU-BLOK) and almost immediately had burning and itching of the affected arm. Progressed to head congestion and headache and needed use of albuterol MDI. Arm was swollen, itchy, pain over injection site. Developed tingling distally. Saw PCP and given 6 day taper of steroids.
Age: 47.0
Sex: F
Vaccine: FLUR3
Symptoms: Paraesthesia, Pruritus, Upper respiratory tract congestion, X-ray limb
Clinical narrative: Received egg free flu (FLU-BLOK) and almost immediately had burning and itching of the affected arm. Progressed to head congestion and headache and needed use of albuterol MDI. Arm was swollen, itchy, pain over injection site. Developed tingling distally. Saw PCP and given 6 day taper of steroids.
Age: 4.0
Sex: F
Vaccine: DTAPIPV, HEPA, MMRV, PNC13
Symptoms: Injection site bruising, Injection site erythema, Injection site warmth
Clinical narrative: Child has bruise and redness on left deltoid muscle - feels hot to touch temperature 98.6. Comfort measures to left arm for comfort. Mom plans to see care of MD or ER will call back with follow-up info.