chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 1.01
Sex: M
Vaccine: VARCEL
Symptoms: Incorrect storage of drug, No adverse event
Clinical narrative: This spontaneous report as received from a nurse refers to a 12 month old male patient. On 07-MAY-2014 the patient was vaccinated with (Oka/Merck) VARIVAX injection (lot # and expiration date not provided) (dose not reported). It was reported that the patient received improperly stored (Oka/Merck) VARIVAX exposed to a maximum temperature of -7C for 27 hours. No adverse effects were reported. This is one of several reports received from the same reporter. Additional information has been requested.
Age: 0.51
Sex: U
Vaccine: HIBV
Symptoms: Incorrect storage of drug, No adverse event
Clinical narrative: This spontaneous report as received from a registered nurse refers to an unspecified number of patients of unknown age and genders. The reporter stated that, on an unspecified date, an unknown number of doses of LIQUID PEDVAXHIB (dose, lot#, expiration dates not provided) that were stored at 48 degrees F for 20 minutes, then exposed to 47 degrees for 9 minutes have been administered. No adverse effects were reported.   Follow up information has been received on 22-JUL-2014 from a receptionist. The reporter stated that there were two different lot numbers of LIQUID PEDVAXHIB that were included in the temperature excursion: Lot # J016188, expiration date: 02-OCT-2016 and lot#J015437, expiration date: 09-OCT-2016. The receptionist did not have any additional information to share with Merck.  Follow up information has been received from the registered nurse who provided patients details. This report refers to a 6 months old infant patient of unknown gender. On 25-JUN-2014 the patient was vaccinated with a dose of LIQUID PEDVAXHIB (dose and route were not reported, lot#J016188, expiration date 02-OCT-2016) that was improperly stored. No adverse effects were reported. This is one of several reports received from the same reporter. Additional information is not expected.
Age: 0.56
Sex: U
Vaccine: HIBV
Symptoms: Incorrect storage of drug, No adverse event
Clinical narrative: This spontaneous report as received from a registered nurse refers to an unspecified number of patients of unknown age and genders. The reporter stated that, on an unspecified date, an unknown number of doses of LIQUID PEDVAXHIB (dose, lot#, expiration dates not provided) that were stored at 48 degrees F for 20 minutes, then exposed to 47 degrees for 9 minutes have been administered. No adverse effects were reported.   Follow up information has been received on 22-JUL-2014 from a receptionist. The reporter stated that there were two different lot numbers of LIQUID PEDVAXHIB that were included in the temperature excursion: Lot # J016188, expiration date: 02-OCT-2016 and lot#J015437, expiration date: 09-OCT-2016. The receptionist did not have any additional information to share with Merck.  Follow up information has been received from the registered nurse who provided patients details. This report refers to a 6 months old infant patient of unknown gender. On 25-JUN-2014 the patient was vaccinated with a dose of LIQUID PEDVAXHIB (dose and route were not reported, lot#J016188, expiration date 02-OCT-2016) that was improperly stored. No adverse effects were reported. This is one of several reports received from the same reporter. Additional information is not expected.
Age: 0.2
Sex: U
Vaccine: HIBV
Symptoms: Incorrect storage of drug, No adverse event
Clinical narrative: This spontaneous report as received from a registered nurse refers to an unspecified number of patients of unknown age and genders. The reporter stated that, on an unspecified date, an unknown number of doses of LIQUID PEDVAXHIB (dose, lot#, expiration dates not provided) that were stored at 48 degrees F for 20 minutes, then exposed to 47 degrees for 9 minutes have been administered. No adverse effects were reported.   Follow up information has been received on 22-JUL-2014 from a receptionist. The reporter stated that there were two different lot numbers of LIQUID PEDVAXHIB that were included in the temperature excursion: Lot # J016188, expiration date: 02-OCT-2016 and lot#J015437, expiration date: 09-OCT-2016. The receptionist did not have any additional information to share with Merck.  Follow up information has been received from the registered nurse who provided patients details. This report refers to a 10 weeks old infant patient of unknown gender. On 24-JUN-2014 the patient was vaccinated with a dose of LIQUID PEDVAXHIB (dose and route were not reported, lot#J015437, expiration date 09-OCT-2016) that was improperly stored. No adverse effects were reported. This is one of several reports received from the same reporter. Additional information is not expected.
Age: 1.07
Sex: M
Vaccine: VARCEL
Symptoms: Incorrect storage of drug, No adverse event
Clinical narrative: This spontaneous report as received from a nurse refers to a 12 month old male patient. On 25-APR-2014 the patient was vaccinated with (Oka/Merck) VARIVAX injection (lot#and expiration date not provided) (dose not reported). It was reported that the patient received improperly stored (Oka/Merck) VARIVAX exposed to a maximum temperature of -7C for 27 hours. No adverse effects were reported. This is one of several reports received from the same reporter. Additional information has been requested.
Age: 1.09
Sex: F
Vaccine: VARCEL
Symptoms: Incorrect storage of drug, No adverse event
Clinical narrative: This spontaneous report as received from a nurse refers to a 13 month old female patient. On 08-MAY-2014 the patient was vaccinated with VARIVAX (lot# and expiration date no provided) (dose not reported). It was reported that the patient was vaccinated with VARIVAX exposed to a maximum temperature of -7C for 27 hours. No adverse effects were reported. This is one of several reports received from the same reporter. Additional information has been requested.
Age: 0.19
Sex: M
Vaccine: PPV
Symptoms: Pyrexia, Upper respiratory tract infection, Wrong drug administered
Clinical narrative: This spontaneous report was received from a medical assistant refers to a 2 month old male patient. Relevant medical history and drug reactions or allergies were reported as none. On 18-JUL-2014 the patient was inadvertently vaccinated with PNEUMOVAX23 (lot# J013344, expiration date: 22-JAN-2015) intramuscular rather than PREVNAR 13. Concomitant medications were reported as none. On 19-JUL-2014, the patient was taken by his parents to an emergency room as he experienced fever for which he was treated with Motrin and was discharged to home. The patient had a follow-up visit at the doctor's office on 22-JUL-2014 and the physician diagnosed the patient with upper respiratory tract infection. Lab diagnostic studies performed were reported as none. Outcome of events were reported as no recovered and causality of the events were unknown. No product quality complaint (PQC) was reported. The patient sought medical attention. Additional information has been requested.
Age: 4.0
Sex: F
Vaccine: DTAPIPV, MMRV
Symptoms: Injection site erythema, Injection site rash, Rash generalised
Clinical narrative: Rash appeared on back of arms on 05/22/2014 along with redness at site of Kinrix. Throughout next 2 days rash spread to face arms back and then legs. No report of fever or itching. No other complaints. Mother took child to ER on 05/24/2014 and she was evaluated and told it probably was from immunizations but really not sure. She was placed on Orapred and mother states child cleared rash about 2 days later. Mother brought in ER visit progress notes along with pictures which is on file.
Age: 7.0
Sex: M
Vaccine: HEPA
Symptoms: Eye swelling, Rash
Clinical narrative: Developed rash on left cheek, swelling noted under left eye, denies itching or difficulty breathing.
Age: 46.0
Sex: M
Vaccine: SMALL
Symptoms: Paraesthesia, Vaccination site reaction
Clinical narrative: C/o tingling around vaccine site and distal posteriorly from vaccine site. He is able to work without weakness or pain.
Age: 0.3
Sex: U
Vaccine: HIBV
Symptoms: Incorrect storage of drug, No adverse event
Clinical narrative: This spontaneous report as received from a registered nurse refers to an unspecified number of patients of unknown age and gender. The reporter stated that, on an unspecified date, and unknown number of doses of LIQUID PEDVAXHIB (dose, lot#, expiration dates not provided) that were stored at 48 degrees F for 20 minutes, then exposed to 47 degrees for 9 minutes have been administered. No adverse effects were reported. Follow up information has been received on 22-JUL-2014 from a receptionist. The reporter stated there were two different lot numbers of LIQUID PEDVAXHIB that were included in the temperature excursion: Lot # J016188, expiration date: 02-OCT-2016 and lot # J015437, expiration date: 09-OCT-2016. The receptionist did not have any additional information to share. Follow-up information from the registered nurse who provided patients details. This refers to a 3 month old infant patient of unknown gender. On 25-JUN-2014 the patient was vaccinated with a dose of LIQUID PEDVAXHIB (dose and route were not reported, lot# J016188, expiration date 02-OCT-2016) that was improperly stored. No adverse effects were reported. This is one of several reports received from the same reporter. Additional information is not expected.
Sex: U
Vaccine: SMALL
Symptoms: Unevaluable event
Clinical narrative: Initial report was received on 24 July 2014 from a health care professional. Verbatim from the report: "Background: The Vaccine Adverse Event Reporting System (VAERS) is a passive reporting system, used for monitoring the safety of all licensed vaccines. In March 2008, ACAM2000 replaced DRYVAX as the only licensed smallpox vaccine and is administered to all persons entering military service and certain civilian researchers. In 2011, routine data mining of VAERS identified a vaccine safety concern resulting in acute ischemic cardiac events (ICE) following ACAM2000. Methods:  During March 1, 2008 through June 30, 2013, we reviewed all serious reports received following ACAM2000 and classified them by diagnostic category. We identified possible ICE cases by searching the Medical Dictionary for Regulatory Affairs (MedDRA) terms for "myocardial ischaemia," "acute myocardial infarction," "myocardial infarction," and "ischaemia," and applied standardized surveillance case definitions. Results: VAERS received 1149 reports following ACAM2000 administration; 169 (14.7%) were serious (resulting in permanent disability, hospitalization or prolongation of hospitalization, life-threatening illness or death), including one death. The two most frequent diagnostic categories for serious reports were cardiovascular and other infectious conditions. The MedDRA search found 31 reports of possible ICE after receipt of ACAM2000 vaccine. Of a total 30 possible ICE cases with demographic information, all but one was male; the age range was 20-45 years (median 32) and median interval to onset of symptoms was 12 days. On clinical review there were 16 cases of myocarditis/pericarditis and 15 ICE cases. Conclusions: Our review of the data mining signal did not substantiate the concerns about ICE after ACAM2000. Our study also suggests that with current pre-vaccination screening, cardiac morbidity in generally healthy vaccinated populations remains uncommon." This case pertains to the unidentified patients in the article who experienced adverse events but did not have fatal outcomes. The two deaths described in this article have been previously reported; details are captured in case numbers 2012-00924 and 2009-00544. Documents held by sender: none.
Age: 0.51
Sex: U
Vaccine: HIBV
Symptoms: Incorrect storage of drug, No adverse event
Clinical narrative: This spontaneous report as received from a registered nurse refers to an unspecified number of patients of unknown age and gender. The reporter stated that, on an unspecified date, and unknown number of doses of LIQUID PEDVAXHIB (dose, lot#, expiration dates not provided) that were stored at 48 degrees F for 20 minutes, then exposed to 47 degrees for 9 minutes have been administered. No adverse effects were reported. Follow up information has been received on 22-JUL-2014 from a receptionist. The reporter stated there were two different lot numbers of LIQUID PEDVAXHIB that were included in the temperature excursion: Lot # J016188, expiration date: 02-OCT-2016 and lot # J015437, expiration date: 09-OCT-2016. The receptionist did not have any additional information to share with Merck. Follow-up information from the registered nurse who provided patients details. This report refers to a 6 month old infant patient of unknown gender. On 25-JUN-2014 the patient was vaccinated with a dose of LIQUID PEDVAXHIB (dose and route were not reported, lot# J014512, expiration date 12-AUG-2016) that was improperly stored. No adverse effects were reported. This is one of several reports received from the same reporter. Additional information is not expected.
Age: 60.0
Sex: M
Vaccine: VARZOS
Symptoms: Injection site erythema, Injection site warmth
Clinical narrative: Warm/reddish at injection site.
Age: 4.0
Sex: F
Vaccine: DTAP
Symptoms: Injection site erythema, Injection site pain, Injection site swelling, Pyrexia
Clinical narrative: Fever Wed, painful red swelling an inch above inj site, down to elbow more than 1/2 way around her arm.
Age: 11.0
Sex: F
Vaccine: HPV4, MNQ, TDAP
Symptoms: Urticaria
Clinical narrative: Hives on ankles, (R) flank, waistline broke out 7/21/14 treating hydroxyzine and triamcinolone.
Age: 0.66
Sex: M
Vaccine: DTAPHEPBIP, HIBV, PNC13, RV5
Symptoms: Crying, Irritability, Pyrexia
Clinical narrative: Received vaccines 7/14/14. Was well. Next 2 days was very irritable, crying all the time, not high pitched. 100.8 fever. No other symptoms. Cried throughout visit in office 7/16/14.
Age: 10.0
Sex: F
Vaccine: MNQ, TDAP
Symptoms: Convulsion, Pallor, Postictal state, Urinary incontinence
Clinical narrative: Tdap, MENACTRA vaccines given. Finger prick done to check cholesterol. Approx 3-5 min. after procedures done, child had seizure lasting approx 30 seconds. Post ictal state, urinary incontinence, lips pale. Hungry prior to procedures. Referred to neuro. Result from neuro - Vaso-vagal. No primary seizure disorder.
Age: 33.0
Sex: M
Vaccine: HEP
Symptoms: Incorrect dose administered, No adverse event
Clinical narrative: Patient was administered dose #3 in Hepatitis B series on 2 JUL 14 at hospital. On 18 JUL, patient was notified by his work center at the that he "was due for a shot" and was again administered a dose of hepatitis B vaccine. Patient did not have any adverse events. Error was realized during an Occupational Health screening approximately 1 week after that.
Age: 43.0
Sex: F
Vaccine: HEPAB, TYP
Symptoms: Headache, Malaise, Pyrexia
Clinical narrative: Patient states experienced headache, fever, malaise next several days after vaccination.
Age: 12.0
Sex: F
Vaccine: HPV4, HPV4, HPVX, HPV4, HPV4
Symptoms: Cardio-respiratory arrest, Death
Clinical narrative: Cardiorespiratory arrest and death.
Age: 12.0
Sex: F
Vaccine: HPV4, HPV4, HPVX, HPV4, HPV4
Symptoms: Death, Fall, Pulse absent, Respiratory arrest, Skin warm
Clinical narrative: Cardiorespiratory arrest and death.
Age: 12.0
Sex: F
Vaccine: HPV4, HPV4, HPVX, HPV4, HPV4
Symptoms: Somnolence, Vomiting
Clinical narrative: Cardiorespiratory arrest and death.
Age: 12.0
Sex: F
Vaccine: HPV4, HPV4, HPVX, HPV4, HPV4
Symptoms: Death
Clinical narrative: Cardiorespiratory arrest and death.
Age: 12.0
Sex: F
Vaccine: HPV4, HPV4, HPVX, HPV4, HPV4
Symptoms: Autopsy, Death, Unresponsive to stimuli
Clinical narrative: Cardiorespiratory arrest and death.
Age: 12.0
Sex: F
Vaccine: HPV4, HPV4, HPVX, HPV4, HPV4
Symptoms: Death, Hypersomnia, Loss of consciousness, Resuscitation, Somnolence
Clinical narrative: Cardiorespiratory arrest and death.
Age: 66.0
Sex: M
Vaccine: FLU3
Symptoms: Ear pain, Influenza, Insomnia
Clinical narrative: Acute ear ache; flu (early December 2013) and insomnia mid March - April 23.
Age: 56.0
Sex: F
Vaccine: FLU3
Symptoms: Aphagia, Asthenia, Blood ketone body, Blood ketone body present, Blood urine present
Clinical narrative: Initial case received on 24 July 2014 from a consumer who is the patient. A 56 year old female patient was vaccinated intramuscularly into the left deltoid on 06 November 2012 with FLUZONE, lot number reported as A726EA (not valid). The patient has NKA (no known allergies). The patient has a history of many previous doses of FLUZONE. The patient denied illness at the time of vaccination. Concomitant medications were not reported. On 06 November 2012, within 10 minutes of the vaccine, she had a 20 minute nose bleed and left arm pain. She has been sick with left arm pain, a frozen shoulder and a variety of other symptoms like vertigo, severe flu for 2 months, laryngitis and increased secretions, falling, right neck pain from shoulder to right neck, fever, numbness and swelling in left axillary area with neuropathy in left arm. Increased sleep of 20-22 hours. Lumps develop on her left arm, back and mild thoracic area around the injection site whenever she uses her left arm. "When the lumps are touched they cause changes in her brain function with brain drifting and memory disorders with a metallic taste in her mouth with chills and general weakness." Dyspnea and cardiac changes with weight gain of 22 pounds overnight when she fell asleep on her left arm. She had high blood pressure and continued weight gain when the doctor pressed on the lumps with irregular heart rhythm. Unable to eat due to edema pressing on her stomach. She had keytones, blood and mucous in her urine. The patient outcome is not recovered. It is reported that the patient was hospitalized (no details). Documents held by sender: None.
Age: 56.0
Sex: F
Vaccine: FLU3
Symptoms: Cardiac disorder, Chills, Dysgeusia, Dyspnoea, Epistaxis
Clinical narrative: Initial case received on 24 July 2014 from a consumer who is the patient. A 56 year old female patient was vaccinated intramuscularly into the left deltoid on 06 November 2012 with FLUZONE, lot number reported as A726EA (not valid). The patient has NKA (no known allergies). The patient has a history of many previous doses of FLUZONE. The patient denied illness at the time of vaccination. Concomitant medications were not reported. On 06 November 2012, within 10 minutes of the vaccine, she had a 20 minute nose bleed and left arm pain. She has been sick with left arm pain, a frozen shoulder and a variety of other symptoms like vertigo, severe flu for 2 months, laryngitis and increased secretions, falling, right neck pain from shoulder to right neck, fever, numbness and swelling in left axillary area with neuropathy in left arm. Increased sleep of 20-22 hours. Lumps develop on her left arm, back and mild thoracic area around the injection site whenever she uses her left arm. "When the lumps are touched they cause changes in her brain function with brain drifting and memory disorders with a metallic taste in her mouth with chills and general weakness." Dyspnea and cardiac changes with weight gain of 22 pounds overnight when she fell asleep on her left arm. She had high blood pressure and continued weight gain when the doctor pressed on the lumps with irregular heart rhythm. Unable to eat due to edema pressing on her stomach. She had keytones, blood and mucous in her urine. The patient outcome is not recovered. It is reported that the patient was hospitalized (no details). Documents held by sender: None.
Age: 56.0
Sex: F
Vaccine: FLU3
Symptoms: Fall, Heart rate irregular, Hypersomnia, Hypertension, Hypoaesthesia
Clinical narrative: Initial case received on 24 July 2014 from a consumer who is the patient. A 56 year old female patient was vaccinated intramuscularly into the left deltoid on 06 November 2012 with FLUZONE, lot number reported as A726EA (not valid). The patient has NKA (no known allergies). The patient has a history of many previous doses of FLUZONE. The patient denied illness at the time of vaccination. Concomitant medications were not reported. On 06 November 2012, within 10 minutes of the vaccine, she had a 20 minute nose bleed and left arm pain. She has been sick with left arm pain, a frozen shoulder and a variety of other symptoms like vertigo, severe flu for 2 months, laryngitis and increased secretions, falling, right neck pain from shoulder to right neck, fever, numbness and swelling in left axillary area with neuropathy in left arm. Increased sleep of 20-22 hours. Lumps develop on her left arm, back and mild thoracic area around the injection site whenever she uses her left arm. "When the lumps are touched they cause changes in her brain function with brain drifting and memory disorders with a metallic taste in her mouth with chills and general weakness." Dyspnea and cardiac changes with weight gain of 22 pounds overnight when she fell asleep on her left arm. She had high blood pressure and continued weight gain when the doctor pressed on the lumps with irregular heart rhythm. Unable to eat due to edema pressing on her stomach. She had keytones, blood and mucous in her urine. The patient outcome is not recovered. It is reported that the patient was hospitalized (no details). Documents held by sender: None.
Age: 56.0
Sex: F
Vaccine: FLU3
Symptoms: Influenza, Injection site mass, Laryngitis, Local swelling, Memory impairment
Clinical narrative: Initial case received on 24 July 2014 from a consumer who is the patient. A 56 year old female patient was vaccinated intramuscularly into the left deltoid on 06 November 2012 with FLUZONE, lot number reported as A726EA (not valid). The patient has NKA (no known allergies). The patient has a history of many previous doses of FLUZONE. The patient denied illness at the time of vaccination. Concomitant medications were not reported. On 06 November 2012, within 10 minutes of the vaccine, she had a 20 minute nose bleed and left arm pain. She has been sick with left arm pain, a frozen shoulder and a variety of other symptoms like vertigo, severe flu for 2 months, laryngitis and increased secretions, falling, right neck pain from shoulder to right neck, fever, numbness and swelling in left axillary area with neuropathy in left arm. Increased sleep of 20-22 hours. Lumps develop on her left arm, back and mild thoracic area around the injection site whenever she uses her left arm. "When the lumps are touched they cause changes in her brain function with brain drifting and memory disorders with a metallic taste in her mouth with chills and general weakness." Dyspnea and cardiac changes with weight gain of 22 pounds overnight when she fell asleep on her left arm. She had high blood pressure and continued weight gain when the doctor pressed on the lumps with irregular heart rhythm. Unable to eat due to edema pressing on her stomach. She had keytones, blood and mucous in her urine. The patient outcome is not recovered. It is reported that the patient was hospitalized (no details). Documents held by sender: None.
Age: 56.0
Sex: F
Vaccine: FLU3
Symptoms: Mental impairment, Neck pain, Nervous system disorder, Neuropathy peripheral, Oedema
Clinical narrative: Initial case received on 24 July 2014 from a consumer who is the patient. A 56 year old female patient was vaccinated intramuscularly into the left deltoid on 06 November 2012 with FLUZONE, lot number reported as A726EA (not valid). The patient has NKA (no known allergies). The patient has a history of many previous doses of FLUZONE. The patient denied illness at the time of vaccination. Concomitant medications were not reported. On 06 November 2012, within 10 minutes of the vaccine, she had a 20 minute nose bleed and left arm pain. She has been sick with left arm pain, a frozen shoulder and a variety of other symptoms like vertigo, severe flu for 2 months, laryngitis and increased secretions, falling, right neck pain from shoulder to right neck, fever, numbness and swelling in left axillary area with neuropathy in left arm. Increased sleep of 20-22 hours. Lumps develop on her left arm, back and mild thoracic area around the injection site whenever she uses her left arm. "When the lumps are touched they cause changes in her brain function with brain drifting and memory disorders with a metallic taste in her mouth with chills and general weakness." Dyspnea and cardiac changes with weight gain of 22 pounds overnight when she fell asleep on her left arm. She had high blood pressure and continued weight gain when the doctor pressed on the lumps with irregular heart rhythm. Unable to eat due to edema pressing on her stomach. She had keytones, blood and mucous in her urine. The patient outcome is not recovered. It is reported that the patient was hospitalized (no details). Documents held by sender: None.
Age: 56.0
Sex: F
Vaccine: FLU3
Symptoms: Pain in extremity, Periarthritis, Pyrexia, Secretion discharge, Urine abnormality
Clinical narrative: Initial case received on 24 July 2014 from a consumer who is the patient. A 56 year old female patient was vaccinated intramuscularly into the left deltoid on 06 November 2012 with FLUZONE, lot number reported as A726EA (not valid). The patient has NKA (no known allergies). The patient has a history of many previous doses of FLUZONE. The patient denied illness at the time of vaccination. Concomitant medications were not reported. On 06 November 2012, within 10 minutes of the vaccine, she had a 20 minute nose bleed and left arm pain. She has been sick with left arm pain, a frozen shoulder and a variety of other symptoms like vertigo, severe flu for 2 months, laryngitis and increased secretions, falling, right neck pain from shoulder to right neck, fever, numbness and swelling in left axillary area with neuropathy in left arm. Increased sleep of 20-22 hours. Lumps develop on her left arm, back and mild thoracic area around the injection site whenever she uses her left arm. "When the lumps are touched they cause changes in her brain function with brain drifting and memory disorders with a metallic taste in her mouth with chills and general weakness." Dyspnea and cardiac changes with weight gain of 22 pounds overnight when she fell asleep on her left arm. She had high blood pressure and continued weight gain when the doctor pressed on the lumps with irregular heart rhythm. Unable to eat due to edema pressing on her stomach. She had keytones, blood and mucous in her urine. The patient outcome is not recovered. It is reported that the patient was hospitalized (no details). Documents held by sender: None.
Age: 56.0
Sex: F
Vaccine: FLU3
Symptoms: Vertigo, Weight increased
Clinical narrative: Initial case received on 24 July 2014 from a consumer who is the patient. A 56 year old female patient was vaccinated intramuscularly into the left deltoid on 06 November 2012 with FLUZONE, lot number reported as A726EA (not valid). The patient has NKA (no known allergies). The patient has a history of many previous doses of FLUZONE. The patient denied illness at the time of vaccination. Concomitant medications were not reported. On 06 November 2012, within 10 minutes of the vaccine, she had a 20 minute nose bleed and left arm pain. She has been sick with left arm pain, a frozen shoulder and a variety of other symptoms like vertigo, severe flu for 2 months, laryngitis and increased secretions, falling, right neck pain from shoulder to right neck, fever, numbness and swelling in left axillary area with neuropathy in left arm. Increased sleep of 20-22 hours. Lumps develop on her left arm, back and mild thoracic area around the injection site whenever she uses her left arm. "When the lumps are touched they cause changes in her brain function with brain drifting and memory disorders with a metallic taste in her mouth with chills and general weakness." Dyspnea and cardiac changes with weight gain of 22 pounds overnight when she fell asleep on her left arm. She had high blood pressure and continued weight gain when the doctor pressed on the lumps with irregular heart rhythm. Unable to eat due to edema pressing on her stomach. She had keytones, blood and mucous in her urine. The patient outcome is not recovered. It is reported that the patient was hospitalized (no details). Documents held by sender: None.
Age: 1.06
Sex: F
Vaccine: VARCEL
Symptoms: Incorrect storage of drug, No adverse event
Clinical narrative: This spontaneous report as received from a nurse refers to a 12 month old female patient. On 22-APR-2014 the patient was vaccinated with VARIVAX (lot# and expiration date not provided) (dose not reported). It was reported that the patient received improperly store VARIVAX exposed to maximum temperature of -7C for 27 hours. No adverse effects were reported. This is one of several reports received from the same reporter. Additional information has been requested.
Age: 1.52
Sex: M
Vaccine: VARCEL
Symptoms: Incorrect storage of drug, No adverse event
Clinical narrative: This spontaneous report as received from a nurse refers to a 18 month old male patient. On 210-MAY-2014 the patient was vaccinated with VARIVAX (lot# and expiration date not provided) (dose not reported). It was reported that the patient received improperly store VARIVAX exposed to maximum temperature of -7C for 27 hours. No adverse effects were reported. This is one of several reports received from the same reporter. Additional information has been requested.
Age: 61.0
Sex: U
Vaccine: VARCEL
Symptoms: No adverse event, Wrong drug administered
Clinical narrative: This spontaneous report was received from a registered nurse refers to a 61 year old patient of unknown gender. No medical history was reported. On 23-JUL-2014, the patient was vaccinated with VARIVAX (dose, route and frequency unspecified). No concomitant medications were reported. On 23-JUL-2014, the patient received VARIVAX rather than ZOSTAVAX. No adverse effects reported. Action taken, outcome and causality were not reported. Additional information has been requested.
Age: 4.0
Sex: U
Vaccine: MMRV
Symptoms: Incorrect storage of drug, No adverse event
Clinical narrative: This spontaneous report was received from a registered nurse refers to a currently 4 year old patient of unknown gender. On an unknown date, the vaccine PROQUAD was improperly stored. On an unknown date, the patient was vaccinated with PROQUAD (dose, route and lot # were not reported). No adverse effects reported. At the time of the report the action taken was not reported. Additional information has been requested.
Age: 0.62
Sex: U
Vaccine: HIBV
Symptoms: Incorrect storage of drug, No adverse event
Clinical narrative: This spontaneous report as received from a registered nurse refers to an unspecified number of patients of unknown age and gender. The reporter stated that, on an unspecified date, and unknown number of doses of LIQUID PEDVAXHIB (dose, lot#, expiration dates not provided) that were stored at 48 degrees F for 20 minutes, then exposed to 47 degrees for 9 minutes have been administered. No adverse effects were reported. Follow up information has been received on 22-JUL-2014 from a receptionist. The reporter stated there were two different lot numbers of LIQUID PEDVAXHIB that were included in the temperature excursion: Lot # J016188, expiration date: 02-OCT-2016 and lot # J015437, expiration date: 09-OCT-2016. The receptionist did not have any additional information to share. Follow-up information from the registered nurse who provided patients details. This report refers to a 7 month old infant patient of unknown gender. On 04-JUN-2014, the patient was vaccinated with a dose of LIQUID PEDVAXHIB (dose and route were not reported, lot# J016188, expiration date 02-OCT-2016) that was improperly stored. No adverse effects were reported. This is one of several reports received from the same reporter. Additional information is not expected.
Sex: U
Vaccine: VARZOS
Symptoms: Expired drug administered, No adverse event
Clinical narrative: This spontaneous report was received from a healthcare worker refers to a patient of unknown age and gender. On 28-JUL-2014 the patient received an expired dose of ZOSTAVAX (lot # J000783, expiration date: 30-APR-2014, subcutaneous, dose unknown). Pertinent medical history and concomitant medications were unspecified. Patient status was reported as no known adverse effects. The outcome of events was unknown. No further information provided. Additional information has been requested.
Age: 27.0
Sex: M
Vaccine: TDAP, TTOX
Symptoms: Nausea, Vomiting
Clinical narrative: Donor c/o nausea and vomiting 20-30 mins. after Tetanus inj. This lasted all night and today c/o N/V.
Age: 0.53
Sex: U
Vaccine: HIBV
Symptoms: Incorrect storage of drug, No adverse event
Clinical narrative: This spontaneous report as received from a registered nurse refers to an unspecified number of patients of unknown age and gender. The reporter stated that, on an unspecified date, and unknown number of doses of LIQUID PEDVAXHIB (dose, lot#, expiration dates not provided) that were stored at 48 degrees F for 20 minutes, then exposed to 47 degrees for 9 minutes have been administered. No adverse effects were reported. Follow up information has been received on 22-JUL-2014 from a receptionist. The reporter stated there were two different lot numbers of LIQUID PEDVAXHIB that were included in the temperature excursion: Lot # J016188, expiration date: 02-OCT-2016 and lot # J015437, expiration date: 09-OCT-2016. The receptionist did not have any additional information to share. Follow-up information from the registered nurse who provided patients details. This report refers to a 6 month old infant patient. On 12-JUN-2014, the patient was vaccinated with a dose of LIQUID PEDVAXHIB (dose and route were not reported, lot# J016188, expiration date 02-OCT-2016) that was improperly stored. No adverse effects were reported. This is one of several reports received from the same reporter. Additional information is not expected because follow has been obtained.
Age: 0.59
Sex: U
Vaccine: HIBV
Symptoms: Incorrect storage of drug, No adverse event
Clinical narrative: This spontaneous report as received from a registered nurse refers to an unspecified number of patients of unknown age and gender. The reporter stated that, on an unspecified date, and unknown number of doses of LIQUID PEDVAXHIB (dose, lot#, expiration dates not provided) that were stored at 48 degrees F for 20 minutes, then exposed to 47 degrees for 9 minutes have been administered. No adverse effects were reported. Follow up information has been received on 22-JUL-2014 from a receptionist. The reporter stated there were two different lot numbers of LIQUID PEDVAXHIB that were included in the temperature excursion: Lot # J016188, expiration date: 02-OCT-2016 and lot # J015437, expiration date: 09-OCT-2016. The receptionist did not have any additional information to share. Follow-up information from the registered nurse who provided patients details. This report refers to a 7 month old infant patient of unknown gender. On 26-JUN-2014, the patient was vaccinated with a dose of LIQUID PEDVAXHIB (dose and route were not reported, lot# J016188, expiration date 02-OCT-2016) that was improperly stored. No adverse effects were reported. This is one of several reports received from the same reporter. Additional information is not expected.
Sex: U
Vaccine: HEP, RV5
Symptoms: Incorrect storage of drug, No adverse event
Clinical narrative: This spontaneous report was received from a healthcare worker refers to 3 unspecified patients of unknown demographics. No medical history was reported. The reporter stated that 3 unspecified patients were administered ROTATEQ and RECOMBIVAX (dose, route and frequency unspecified) that were stored improperly. No concomitant medications were reported. Nurse was then placed on the line answer additional questions regarding event. No adverse effects were reported. No further information was provided. Additional information has been requested.
Age: 13.0
Sex: M
Vaccine: HEPA, HPV4
Symptoms: Blood pressure normal, Dizziness
Clinical narrative: This spontaneous report as received from a patient's father concerning a 13 year old male patient. Patient's concurrent conditions and relevant medical history was unknown. On 28-JUL-2014 the patient was vaccinated with third dose of GARDASIL (dose and route unspecified). The reporter stated that the patient also received unspecified hepatitis a vaccine, inactivated (manufacturer unknown) at the same time. Concomitant medications were unknown. The reporter stated that the patient felt light-headed about 2-3 minutes after receiving third dose of GARDASIL and the patient sat down immediately due to the reaction. Blood pressure was taken after the reaction and it was normal. The patient was not treated for the adverse event. The patient began recovering about ten to fifteen minutes after experiencing the reaction and the reporter also stated that the patient was still recovering a half hour after receiving the GARDASIL. The reporter stated that the reaction occurred in the physician's office. The outcome of the event was recovering/resolving. The causality of the event with GARDASIL was not reported. Product quality issue was not involved. The patient's father also reported that similar reactions from his other sone and daughter which have been documented in SR #1-12018612746 and SR#1-12018612610. The case is linked to #1407USA013430 and #1407USA013445 via same reporter link. Additional information has been requested.
Sex: U
Vaccine: MMRV
Symptoms: Incorrect storage of drug, No adverse event
Clinical narrative: This spontaneous report was received from a registered nurse refers to a currently 5 year old patient of unknown gender. On an unknown date, the vaccine PROQUAD (Merck) was improperly stored. On an unknown date, the patient was vaccinated with PROQUAD (Merck) (dose, route and lot # were not reported). No adverse effects reported. At the time of the report the action taken was not reported. Additional information has been requested.
Age: 13.0
Sex: M
Vaccine: HPV4
Symptoms: Colonoscopy abnormal, Cytogenetic analysis normal, Drug metabolising enzyme test abnormal, Gastrointestinal inflammation, Haematochezia
Clinical narrative: Bloody stool and rectal bleeding during every bowel movement every day starting a week after administration of the Gardasil vaccine. ER visit 3/15/2014. Colonoscopy 3/27/2014. Medications: Apriso (5 months) no treatment results. Prednisone (7 weeks) no treatment results. Mercaptopurine (2 months) elevated liver enzymes & not metabolizing drug effectively. Mercaptopurine combined with Allopurinol (2 weeks) no treatment results.
Age: 13.0
Sex: M
Vaccine: HPV4
Symptoms: Hepatic enzyme increased, Rectal haemorrhage
Clinical narrative: Bloody stool and rectal bleeding during every bowel movement every day starting a week after administration of the Gardasil vaccine. ER visit 3/15/2014. Colonoscopy 3/27/2014. Medications: Apriso (5 months) no treatment results. Prednisone (7 weeks) no treatment results. Mercaptopurine (2 months) elevated liver enzymes & not metabolizing drug effectively. Mercaptopurine combined with Allopurinol (2 weeks) no treatment results.
Age: 72.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site rash, Rash
Clinical narrative: Rash around injection site of few inch diameter, rash on bilateral shin/calf few days later, rash below nape of neck week post-vaccination.
Age: 11.0
Sex: M
Vaccine: TDAP
Symptoms: Agitation, Gaze palsy, Posturing, Pulse abnormal, Unresponsive to stimuli
Clinical narrative: Called to pt's car where he was unresponsive with thready pulse. Sternal rub given by staff. Pt then began with decerebrate posturing, eyes rolled back, and not responsive to name for several seconds. After which, patient stopped with these activities and was awake but agitated. Oxygen via NC and cool cloth applied to patient until EMS services arrived and took over care of patient and transported him to hospital.
Age: 15.0
Sex: F
Vaccine: HPV4
Symptoms: Exposure during pregnancy, Presyncope
Clinical narrative: This spontaneous prospective pregnancy report as received from a registered nurse via company representative refers to a 15 year old female patient. On an unknown date the patient was vaccinated with a first dose of GARDASIL (dose, route of administration, LOT# and expiration date were not provided). On an unknown date, the patient became pregnant. The date of last menstrual period (LMP) and estimated due date (EDD) was not known. The pregnancy outcome was pending. On an unknown date the patient experienced prolonged vagal response after receiving a first dose of GARDASIL. The patient sought medical attention by visiting the office. The outcome of prolonged vagal response was not reported. The relatedness between prolonged vagal response and GARDASIL was not reported. Additional information has been requested.
Age: 0.56
Sex: U
Vaccine: HIBV
Symptoms: Incorrect storage of drug, No adverse event
Clinical narrative: This spontaneous report as received from a registered nurse refers to an unspecified number of patients of unknown age and gender. The reporter stated that, on an unspecified date, and unknown number of doses of LIQUID PEDVAXHIB (dose, lot#, expiration dates not provided) that were stored at 48 degrees F for 20 minutes, then exposed to 47 degrees for 9 minutes have been administered. No adverse effects were reported. Follow up information has been received on 22-JUL-2014 from a receptionist. The reporter stated there were two different lot numbers of LIQUID PEDVAXHIB that were included in the temperature excursion: Lot # J016188, expiration date: 02-OCT-2016 and lot # J015437, expiration date: 09-OCT-2016. The receptionist did not have any additional information to share. Follow-up information from the registered nurse who provided patients details. This report refers to a 6 month old infant patient. On 12-JUN-2014, the patient was vaccinated with a dose of LIQUID PEDVAXHIB lot# J015437, expiration date 09-OCT-2016 (dose and route were not reported) that was improperly stored. No adverse effects were reported. This is one of several reports received from the same reporter. Additional information is not expected because follow us has been obtained.
Age: 0.64
Sex: U
Vaccine: HIBV
Symptoms: Incorrect storage of drug, No adverse event
Clinical narrative: This spontaneous report as received from a registered nurse refers to an unspecified number of patients of unknown age and gender. The reporter stated that, on an unspecified date, and unknown number of doses of LIQUID PEDVAXHIB (dose, lot#, expiration dates not provided) that were stored at 48 degrees F for 20 minutes, then exposed to 47 degrees for 9 minutes have been administered. No adverse effects were reported. Follow up information has been received on 22-JUL-2014 from a receptionist. The reporter stated there were two different lot numbers of LIQUID PEDVAXHIB that were included in the temperature excursion: Lot # J016188, expiration date: 02-OCT-2016 and lot # J015437, expiration date: 09-OCT-2016. The receptionist did not have any additional information to share. Follow-up information from the registered nurse who provided patients details. This report refers to a 7 month old infant patient of unknown gender. On 03-JUN-2014, the patient was vaccinated with a dose of LIQUID PEDVAXHIB (dose and route were not reported, lot# J016188, expiration date 02-OCT-2016) that was improperly stored. No adverse effects were reported. This is one of several reports received from the same reporter. Additional information is not expected.
Age: 54.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site erythema, Injection site pain, Injection site paraesthesia, Injection site swelling
Clinical narrative: Injection 7/28 with ZOSTAVAX. 7/29 burning, tingling, pain at injection site. 7/30 presented to office - swollen, wamr >6 cm firm injection site, erythema, was given prednisone and cephalexin/no fever.
Age: 1.41
Sex: U
Vaccine: HIBV
Symptoms: Incorrect storage of drug, No adverse event
Clinical narrative: This spontaneous report as received from a registered nurse refers to an unspecified number of patients of unknown age and gender. The reporter stated that, on an unspecified date, and unknown number of doses of LIQUID PEDVAXHIB (dose, lot#, expiration dates not provided) that were stored at 48 degrees F for 20 minutes, then exposed to 47 degrees for 9 minutes have been administered. No adverse effects were reported. Follow up information has been received on 22-JUL-2014 from a receptionist. The reporter stated there were two different lot numbers of LIQUID PEDVAXHIB that were included in the temperature excursion: Lot # J016188, expiration date: 02-OCT-2016 and lot # J015437, expiration date: 09-OCT-2016. The receptionist did not have any additional information to share. Follow-up information from the registered nurse who provided patients details. This report refers to a 16 month old infant patient of unknown gender. On 30-MAY-2014 the patient was vaccinated with a dose of LIQUID PEDVAXHIB (dose and route were not reported, lot# J016188, expiration date 02-OCT-2016) that was improperly stored. No adverse effects were reported. This is one of several reports received from the same reporter. Additional information is not expected.
Age: 0.39
Sex: U
Vaccine: HIBV
Symptoms: Incorrect storage of drug, No adverse event
Clinical narrative: This spontaneous report as received from a registered nurse refers to an unspecified number of patients of unknown age and gender. The reporter stated that, on an unspecified date, and unknown number of doses of LIQUID PEDVAXHIB (dose, lot#, expiration dates not provided) that were stored at 48 degrees F for 20 minutes, then exposed to 47 degrees for 9 minutes have been administered. No adverse effects were reported. Follow up information has been received on 22-JUL-2014 from a receptionist. The reporter stated there were two different lot numbers of LIQUID PEDVAXHIB that were included in the temperature excursion: Lot # J016188, expiration date: 02-OCT-2016 and lot # J015437, expiration date: 09-OCT-2016. The receptionist did not have any additional information to share. Follow-up information from the registered nurse who provided patients details. This report refers to a 4 month old infant patient of unknown gender. On 03-JUN-2014 the patient was vaccinated with a dose of LIQUID PEDVAXHIB (dose and route were not reported, lot# J016188, expiration date 02-OCT-2016) that was improperly stored. No adverse effects were reported. This is one of several reports received from the same reporter. Additional information is not expected.
Sex: U
Vaccine: MMRV
Symptoms: Incorrect storage of drug, No adverse event
Clinical narrative: This spontaneous report was received from a registered nurse refers to a currently 4 year old patient of unknown gender. On an unknown date, the vaccine PROQUAD was improperly stored. On an unknown date, the patient was vaccinated with PROQUAD (Merck) (dose, route and lot # were not reported). No adverse effects reported. At the time of the report the action taken was not reported. This is one of several reports from the same source. Additional information has been requested.
Age: 5.0
Sex: M
Vaccine: DTAP, IPV, MMR, VARCEL
Symptoms: Injection site erythema, Injection site swelling, Injection site warmth
Clinical narrative: Erythema, swelling, and warm to the touch noted at vaccine injection site (2 days after injection). Abx and 3-day course of steroids given.
Sex: F
Vaccine: VARCEL
Symptoms: Incorrect storage of drug, No adverse event
Clinical narrative: This spontaneous report was received from a registered nurse refers to a currently 4 year old female patient. On an unknown date, the VARIVAX was improperly stored. On an unknown date, the patient was vaccinated with VARIVAX (dose, route and lot# were not reported). No adverse effects reported. At the time of the report the action taken was not reported. This is one report of several reports from the same source. Additional information has been requested.
Age: 11.0
Sex: M
Vaccine: MNQ, TDAP
Symptoms: Injection site erythema, Injection site rash, Injection site swelling, Rash macular
Clinical narrative: 7-31-14 - Had well ck-up. 7-31-14 - 2 immunizations given at 11:40 am - Tdap (BOOSTRIX) given in left arm and Meningitis (MENVEO) in right arm. About 1 min past while recking B/P and an 8 cm blotchy red rash appeared at injection site, small bump. Dr advised ZYRTEC 10 mg p.o. at 11:45 am. BP's LA - 100/80 RA -94/60. Ice pack to left arm for 10-15 min. About 11:55, reaction down to about size of quarter. Small bump still felt. Dr notified. B/P reck'd LA - 96/76, RA 96/64. Ok to leave.