chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 30.0
Sex: M
Vaccine: FLU3
Symptoms: Full blood count normal, Headache, Influenza like illness, Loss of consciousness, Metabolic function test normal
Clinical narrative: This 31 yo patient advised he has recurrent worsening of commonly reported side effects to Influenza vaccine. Between 2010-2014 each annual flu shot, IIV or mist, resulted in headaches, sensation of fever, body aches, stomachaches/nausea wo vomiting, which could last 1-3 days. Vaccines were typically given prior to a 4 day weekend so he would spend the weekend in bed and was back to normal self by day 4. Symptoms were worse with the nasal flu. However following 2015 flu shot he had a syncopal episode about 12 hours post vaccination. He had been there for several months, had no current illness, no exposures to chemicals/gas, has no PMH, has an allergy to avocadoes; no true seasonal allergy (if pollen high has issues otherwise okay) and is on no medications. He advised he received annual flu about 1600 hr, went and ate dinner (same items prior to and after vaccine has no reaction), about 3-4 hours after vaccination he began to experience a diffuse headache, body aches, stomach ache and feverish similar to past reactions, but faster in onset and severity. He went to bed believing these were expected side effects he had before with every flu shot. About 2-230am he left home walked about 100 feet to a port a john to urinate. While urinating, he advised his head was throbbing 10/10, his nausea worsened to point he knew he was going to vomit, felt dizzy and then recalls nothing - he passed out. He was found by buddies about 3am outside of toilet against a barrier wall support, pants unzipped, no visible injuries from falling out of toilet. He had to be shaken for him to arouse. He was taken to medical center where he reported a severe headache and flu like symptoms. He was treated with ZOFRAN which relieved nausea within 5 minutes; however when he sat up to drink water as he was thirsty, he again wanted to pass out feeling lightheadedness/nauseated which resolved lying down. Providers then treated with PHENERGAN and 1 liter of D5NS. Medical records document BS of 69, BP 93-67 unknown heart rate, but BP reported as normal after 1 lither of fluid. CBC, CMP, UA, EKG all normal. He has not had any similar reaction since. He does admit to head injuries in past causing him to be dizzy, but nothing like this has ever happened. He questions relationship/allergy to flu vaccine. Vaccine site had no reported reaction.
Age: 30.0
Sex: M
Vaccine: FLU3
Symptoms: Nausea, Pain, Pyrexia, Syncope, Thirst
Clinical narrative: This 31 yo patient advised he has recurrent worsening of commonly reported side effects to Influenza vaccine. Between 2010-2014 each annual flu shot, IIV or mist, resulted in headaches, sensation of fever, body aches, stomachaches/nausea wo vomiting, which could last 1-3 days. Vaccines were typically given prior to a 4 day weekend so he would spend the weekend in bed and was back to normal self by day 4. Symptoms were worse with the nasal flu. However following 2015 flu shot he had a syncopal episode about 12 hours post vaccination. He had been there for several months, had no current illness, no exposures to chemicals/gas, has no PMH, has an allergy to avocadoes; no true seasonal allergy (if pollen high has issues otherwise okay) and is on no medications. He advised he received annual flu about 1600 hr, went and ate dinner (same items prior to and after vaccine has no reaction), about 3-4 hours after vaccination he began to experience a diffuse headache, body aches, stomach ache and feverish similar to past reactions, but faster in onset and severity. He went to bed believing these were expected side effects he had before with every flu shot. About 2-230am he left home walked about 100 feet to a port a john to urinate. While urinating, he advised his head was throbbing 10/10, his nausea worsened to point he knew he was going to vomit, felt dizzy and then recalls nothing - he passed out. He was found by buddies about 3am outside of toilet against a barrier wall support, pants unzipped, no visible injuries from falling out of toilet. He had to be shaken for him to arouse. He was taken to medical center where he reported a severe headache and flu like symptoms. He was treated with ZOFRAN which relieved nausea within 5 minutes; however when he sat up to drink water as he was thirsty, he again wanted to pass out feeling lightheadedness/nauseated which resolved lying down. Providers then treated with PHENERGAN and 1 liter of D5NS. Medical records document BS of 69, BP 93-67 unknown heart rate, but BP reported as normal after 1 lither of fluid. CBC, CMP, UA, EKG all normal. He has not had any similar reaction since. He does admit to head injuries in past causing him to be dizzy, but nothing like this has ever happened. He questions relationship/allergy to flu vaccine. Vaccine site had no reported reaction.
Age: 30.0
Sex: M
Vaccine: FLU3
Symptoms: Urine analysis normal
Clinical narrative: This 31 yo patient advised he has recurrent worsening of commonly reported side effects to Influenza vaccine. Between 2010-2014 each annual flu shot, IIV or mist, resulted in headaches, sensation of fever, body aches, stomachaches/nausea wo vomiting, which could last 1-3 days. Vaccines were typically given prior to a 4 day weekend so he would spend the weekend in bed and was back to normal self by day 4. Symptoms were worse with the nasal flu. However following 2015 flu shot he had a syncopal episode about 12 hours post vaccination. He had been there for several months, had no current illness, no exposures to chemicals/gas, has no PMH, has an allergy to avocadoes; no true seasonal allergy (if pollen high has issues otherwise okay) and is on no medications. He advised he received annual flu about 1600 hr, went and ate dinner (same items prior to and after vaccine has no reaction), about 3-4 hours after vaccination he began to experience a diffuse headache, body aches, stomach ache and feverish similar to past reactions, but faster in onset and severity. He went to bed believing these were expected side effects he had before with every flu shot. About 2-230am he left home walked about 100 feet to a port a john to urinate. While urinating, he advised his head was throbbing 10/10, his nausea worsened to point he knew he was going to vomit, felt dizzy and then recalls nothing - he passed out. He was found by buddies about 3am outside of toilet against a barrier wall support, pants unzipped, no visible injuries from falling out of toilet. He had to be shaken for him to arouse. He was taken to medical center where he reported a severe headache and flu like symptoms. He was treated with ZOFRAN which relieved nausea within 5 minutes; however when he sat up to drink water as he was thirsty, he again wanted to pass out feeling lightheadedness/nauseated which resolved lying down. Providers then treated with PHENERGAN and 1 liter of D5NS. Medical records document BS of 69, BP 93-67 unknown heart rate, but BP reported as normal after 1 lither of fluid. CBC, CMP, UA, EKG all normal. He has not had any similar reaction since. He does admit to head injuries in past causing him to be dizzy, but nothing like this has ever happened. He questions relationship/allergy to flu vaccine. Vaccine site had no reported reaction.
Age: 23.0
Sex: F
Vaccine: FLU3
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: Case number PHEH2015US06992, is an initial spontaneous report received from a nurse on 22 Dec 2015. This report refers to a 23 years old female patient. Medical history was not reported. Concomitant medication was not reported. The patient was vaccinated with FLUVIRIN (batch number: 1514501 and expiry date: May 2016) in left deltoid on 07 Oct 2015. It was reported that before administration the FLUVIRIN had a temperature excursion of 34 degrees. The reporter stated that she did not know why the refrigerator was out of temperature range for an unspecified amount of time overnight. She checked the temperature before she left for the day and when she arrived the next day and the temperature was fine. It was a new refrigerator and there have not been any problems since the temperature excursion. No adverse reaction was experienced by the patient following the maladministration. No further information was provided. Follow up information received from the nurse on 26 Jan 2016: Reporter comment updated.
Age: 24.0
Sex: F
Vaccine: FLU3
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: Case number PHEH2015US027172, is an initial spontaneous report received from a medical assistant on 24 Dec 2015. This report refers to a 24-year-old female patient. Past medical history and concomitant medication were not reported. The patient was vaccinated with FLUVIRIN (batch number: 1516201) at a dose of 0.5ml intramuscularly on an unknown date which was stored out of recommended temperature range (temperature excursion of 55.6 degree Fahrenheit/at 7:50am the temperature was 38 degrees and at 3:50pm the temperature was 38.3 degrees). No adverse event reported following this medication errors.
Sex: M
Vaccine: FLU3
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: Case number PHEH2015US027173, is an initial spontaneous report received from a medical assistant on 24 Dec 2015. This report refers to a 59 years old male patient. Past medical history and concomitant medication were not reported. The patient was vaccinated with FLUVIRIN (batch number: 1516201) at a dose of 0.5ml, intramuscularly on an unknown date which was stored out of recommended temperature range (temperature excursion of 55.6 degree Fahrenheit/at 7:50 am the temperature was 38 degrees and at 3:50pm the temperature was 38.3 degrees). No adverse event reported following this medication errors (incorrect storage of drug).
Age: 63.0
Sex: M
Vaccine: FLU3
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: Case number PHEH2015US027174, is an initial spontaneous report received from a medical assistant on 24 Dec 2015. This report refers to a 63 years old male patient. Past medical history and concomitant medication were not reported. The patient was vaccinated with FLUVIRIN (batch number: 1516201) at a dose of 0.5 ml, intramuscularly on an unknown date which was stored out of recommended temperature range (temperature excursion of 55.6 degree Fahrenheit/at 7.50 am the temperature was 38 degrees and at 3.50pm the temperature was 38.3 degrees). No adverse event reported following this medication errors.
Sex: U
Vaccine: FLU3
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: Case number PHEH2016US010685 is initial spontaneous report received from other healthcare professional on 27 Apr 2016. This report refers to patient of unknown age and gender. Medical history and current condition were not reported. The patient was vaccinated with FLUVIRIN (batch number: 1515101) intramuscularly at a dose of 0.5 ml on an unknown date. It was reported that, unknown number of FLUVIRIN vaccinations were given following multiple temperature excursions below 36 degrees Fahrenheit and excursions 30 degrees for greater than 24 hours and 26 degrees Fahrenheit for 12 hours. No adverse event was reported following this medication error. This case was considered as lost to follow up as there was no consent to contact with reporter.
Sex: F
Vaccine: FLU3
Symptoms: No adverse event, Product use issue
Clinical narrative: Case number PHEH2015US027321, is an initial spontaneous report received from a consumer on 9 Dec 2015. This report refers to a female patient of unspecified age. Past medical history and concomitant medications were not reported. The patient was vaccinated with unapproved batch of FLUVIRIN (batch number: 1514501) on an unknown date. No adverse event was reported following administration of unapproved batch of FLUVIRIN.
Age: 0.58
Sex: F
Vaccine: DTAPHEPBIP, FLU3, HEP, IPV, PPV, RVX
Symptoms: Drug administered to patient of inappropriate age, No adverse event
Clinical narrative: Case number PHEH2015US027575, is an initial spontaneous report received from a healthcare progression on 31 Dec 2015. This report refers to an 08-months-old female neonate. Past medical history and concomitant medications were not reported. Prior vaccination history included as PEDIARIX vaccine, PEDVAX-HIB vaccine, pneumococcal vaccine, polio vaccine and rotavirus vaccine on 24 Jul 2015 and 28 Sep 2015. The patient also vaccinated with Hepatitis B vaccine on 24 Jul 2015. She was vaccinated with FLUVIRIN (batch number: 1515401) into left thigh, at a dose of 0.5 ml, intramuscularly on 31 Dec 2015 at 14:00 pm, when she was 08 months old. The patient also vaccinated with PEDIARIX vaccine (other manufacturer, batch number: not reported), hepatitis B vaccine (other manufacturer, batch number: not reported), pneumococcal vaccine (other manufacturer, batch number: not reported), Polio (other manufacturer, batch number: not reported) and Rotavirus vaccine (manufacturer, batch number: not reported) on 31 Dec 2015. No adverse event was reported following this administration error. Follow up report received from a healthcare professional on 23 Feb 2016: Added prior vaccination history, suspect drug information (vaccination site, dose and vaccination time), other suspect vaccine (PEDIARIX vaccine, hepatitis B, pneumococcal, Polio and Rotavirus vaccine). Follow up report received from a healthcare professional on 09 May 2016: Anatomical location of vaccine administration and patient's height updated.
Sex: U
Vaccine: FLU3
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: Case number PHEH2016017632, is an initial spontaneous report received from pharmacist on 12 Jul 2016. This report refers to a 31 years old patient of unknown gender. Medical history and concomitant medications were not reported. The patient was vaccinated with FLUVIRIN (batch number: 1515701) intramuscularly in left arm at a dose of 0.5 ml on 14 Jan 2016. On an unspecified date, FLUVIRIN that had been exposed to 8 to 10 temperature excursions was administered to an unknown number of patients. No adverse event was reported following this administration error (incorrect storage of drug). Follow up report received from a nurse on 13 Sep 2016: Updated patient demographics (age and date of birth), suspect drug information (left arm and vaccination date).
Age: 43.0
Sex: M
Vaccine: FLU3
Symptoms: Blood test, Facial pain, Hypoaesthesia, Paraesthesia
Clinical narrative: Case number PHEH2016US000960, is an initial spontaneous report received from a pharmacist on 11 Jan 2016. This report refers to a 43-years-old male patient. Past medical history and concomitant medications were not reported. The patient was vaccinated with FLUVIRIN (batch number: 158101) in left deltoid intramuscularly at a dose of 0.5 ml on 06 Jan 2016 (earlier reported as 05 Jan 2016). On 07 Jan 2016 (earlier reported as 06 Jan 2016), the patient experienced pain, tingling/numbness in/on face that got worse. The patient went to the urgent care and did blood tests (results unspecified). Upon follow up, the pharmacist reported that, he left a message for patient and did not receive response from the patient. The outcome of the events was unknown. The seriousness and causality of the events was not reported. Follow up report received from a pharmacist on 22 Mar 2016: Updated suspect drug information (anatomical area of administration, dose and therapy start date), event information (start date of events) and pharmacist comments.
Age: 22.0
Sex: F
Vaccine: FLU3
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: Case number PHEH2015US026930 is a spontaneous report initially received from a nurse on 22 Dec 2015. This report refers to a 22 years old female patient. Past medical history and concomitant medication were not reported. The patient was vaccinated with FLUVIRIN (batch number: 1514501 and expiry date: May 2016) into the right deltoid on 29 Oct 2015. It was reported that FLUVIRIN administered to the patient had a temperature excursion of 34 degrees. The reporter stated that she did not know why the refrigerator was out of temperature range for an unspecified amount of time overnight. She checked the temperature before she left for the day and when arrived the next day and the temperature was fine. It was a new refrigerator and there have not been any problems since the temperature excursion. No adverse reaction was experienced by the patient following the maladministration. No further problem provided. Follow up information received from the nurse on 26 Jan 2016: Reporter's comment updated.
Age: 51.0
Sex: F
Vaccine: FLU3
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: Case number PHEH2015US026969, is a spontaneous report initially received from a nurse on 22 Dec 2015. This report refers to a 51 year old female patient. Medical history was not reported. Concomitant medication was not reported. The patient was vaccinated with FLUVIRIN (batch number: 1514501, expiry date: May 2016) into left deltoid on 14 Oct 2015. It was reported that before administration the FLUVIRIN had a temperature excursion of 34 degrees. The reporter stated that she did not know why the refrigerator was out of temperature before she left for the day and when she arrived the next day and the temperature was fine. It was new refrigerator and there were no problems since the temperature excursion. No adverse reaction was experienced by the patient following the maladministration. Follow up information received via nurse on 26 Jan 2016: Reporter's comments updated.
Age: 33.0
Sex: F
Vaccine: FLU3
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: Case number PHEH2015US026970, is a spontaneous report initially received from a nurse on 22 Dec 2015. This report refers to a 33 years old female patient. Medical history was not reported. Concomitant medication was not reported. The patient was vaccinated with FLUVIRIN (batch number: 1514501, expiry date: May 2016) into left deltoid on 05 Oct 2015. It was reported that FLUVIRIN administered to the patient had a temperature excursion of 34 degrees. The reporter stated that she did not know why the refrigerator was out of temperature range for an unspecified amount of time overnight. She checked the temperature before she left for the day and when she arrived the next day and the temperature was fine. It was a new refrigerator and there were no problems since the temperature excursion. No adverse reaction was experienced by the patient following the maladministration. Follow up information received via nurse on 26 Jan 2016: Reporter's comments updated.
Age: 63.0
Sex: M
Vaccine: FLU3
Symptoms: Expired product administered, No adverse event
Clinical narrative: Case number PHEH2016US022039 is an initial spontaneous report received from physician on 25 Aug 2016. This report refers to 63 year old male patient. Medical history and concomitant medications were not reported. The patient was vaccinated with FLUVIRIN (batch number: 1517501, expiry date: Jun 2016) at a dose of 0.5 ml intramuscularly 25 Aug 2016, which was expired in Jun 2016. The Six patient were administered FLUVIRIN that was expired in Jun 2016. No adverse event was reported following this medication error.
Age: 22.0
Sex: F
Vaccine: FLU3
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: Case number PHEH2015US026971, is a spontaneous report initially  received from a nurse on 22 Dec 2015. This report refers to a 22 years old female patient. Medical history was not reported. Concomitant medication was not reported. The patient was vaccinated with FLUVIRIN (batch number: 1514501, expiry date: May 2016) into left deltoid on 19 Oct 2015. It was reported that FLUVIRIN administered to the patient had a temperature excursion of 34 degrees. The reporter stated that she did not know why the refrigerator was out of temperature range for an unspecified amount of time overnight. She checked the temperature before she left for the day and when she arrived the next day and the temperature was fine. It was a new refrigerator and there were no problems since the temperature excursion. No adverse reaction was experienced by the patient following the maladministration. Follow up information received from the nurse on 26 Jan 2016: Reporter's comment updated.
Age: 43.0
Sex: F
Vaccine: FLU3
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: Case number PHEH2015US026972, is a spontaneous report initially received from a nurse on 22 Dec 2015. This report refers to a 43 years old female patient. Medical history was not reported. Concomitant medication was not reported. The patient was vaccinated with FLUVIRIN (batch number: 1514501, expiry date: May 2016) into left deltoid on 05 Oct 2015. It was reported that FLUVIRIN administered to the patient had a temperature excursion of 34 degrees. The reporter stated that she did not know why the refrigerator was out of temperature range for an unspecified amount of time overnight. She checked the temperature before she left for the day and when she arrived the next day and the temperature was fine. It was a new refrigerator and there were no problems since the temperature excursion. No adverse reaction was experienced by the patient following the maladministration. Follow up information received via nurse on 26 Jan 2016: Reporter's comments updated.
Age: 60.0
Sex: M
Vaccine: FLU3
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: Case number PHEH2015US026975, is a spontaneous report initially received from a nurse on 22 Dec 2015. This report refers to a 60 years old male patient. Medical history was not reported. Concomitant medication was not reported. The patient was vaccinated with FLUVIRIN (batch number: 1514501, expiry date: May 2016) into left deltoid on 06 Oct 2015. It was reported that FLUVIRIN administered to the patient had a temperature excursion of 34 degrees. The reporter stated that she did not know why the refrigerator was out of temperature range for an unspecified amount of time overnight. She checked the temperature before she left for the day and when she arrived the next day and the temperature was fine. It was a new refrigerator and there were no problems since the temperature excursion. No adverse reaction was experienced by the patient following the maladministration. Follow up information received via nurse on 26 Jan 2016: Reporter's comment updated.
Age: 39.0
Sex: F
Vaccine: FLU3
Symptoms: Expired product administered, No adverse event
Clinical narrative: Case number PHEH2016US002606, is a spontaneous report initially received from a pharmacist on 29 Jan 2016. This report refers to a 39 years old female patient. Past medical history and concomitant medications were not reported. She was vaccinated with expired FLUVIRIN multi dose vial (batch number: 1412071, expiry date: Jun 2015) intramuscularly on 08 Jan 2016. No adverse event was reported following this medication error. Reporter stated that patient did not report any problems. Follow up information received from a pharmacist on 02 Feb 2016: Added reporter's comment.
Age: 52.0
Sex: F
Vaccine: FLU3
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: Case number PHEH2015US026976, is a spontaneous report initially received from a nurse on 22 Dec 2015. This report refers to a 52 years old female patient. Medical history was not reported. Concomitant medication was not reported. The patient was vaccinated with FLUVIRIN (batch number: 1514501, expiry date: May 2016) into left deltoid on 06 Oct 2015. It was reported that FLUVIRIN administered to the patient had a temperature excursion of 34 degrees. The reporter stated that she did not know why the refrigerator was out of temperature range for an unspecified amount of time overnight. She checked the temperature before she left for the day and when she arrived the next day and the temperature was fine. It was a new refrigerator and there were no problems since the temperature excursion. No adverse reaction was experienced by the patient following the maladministration. Follow up information received via nurse on 26 Jan 2016: Reporter's comment updated.
Age: 35.0
Sex: F
Vaccine: FLU3
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: Case number PHEH2015US026977 is a spontaneous report initially received from a nurse on 22 Dec 2015. This report refers to a 35-year-old female patient. Medical history was not reported. Concomitant medication was not reported. The patient was vaccinated with reported that FLUVIRIN administered to the patient had a temperature excursion of 34 degrees. The reporter stated that the she did not know why the refrigerator was out of temperature range for an unspecified amount of time overnight. She checked the temperature before she left for the day and when she arrived the next day and the temperature was fine. It was a new refrigerator and there were no problems since the temperature excursion. No adverse reaction was experienced by the patient following the maladministration. Follow up information received via nurse on 26 Jan 2016: Reporter's comments updated.
Age: 35.0
Sex: F
Vaccine: FLU3
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: Case number PHEH2015US026978, is a spontaneous report initially received from a nurse on 22 Dec 2015. This report refers to a 35 years old female patient. Medical history was not reported. Concomitant medication was not reported. The patient was vaccinated with FLUVIRIN (batch number: 1514501, expiry date: May 2016) into left deltoid on 23 Oct 2015. It was reported that FLUVIRIN administered to the patient had a temperature excursion of 34 degrees. The reporter stated that she did not know why the refrigerator was out of temperature range for an unspecified amount of time overnight. She checked the temperature before she left for the day and when she arrived the next day and the temperature was fine. It was a new refrigerator and there were no problems since the temperature excursion. No adverse reaction was experienced by the patient following the maladministration. Follow up information received via nurse on 26 Jan 2016: Reporter's comments updated.
Age: 29.0
Sex: M
Vaccine: FLU3
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: Case number PHEH2015US026981, is an initial spontaneous report received from a nurse on 22 Dec 2015. This report refers to a 29-year-old male patient. Medical history was not reported. Concomitant medication was not reported. The patient was vaccinated with FLUVIRIN (batch number: 1514501, expiry date: May 2016) into left deltoid on 24 Oct 2015. It was reported that before administration the FLUVIRIN had a temperature excursion of 34 degrees. The reporter stated that she did not know why the refrigerator was out of temperature range for an unspecified amount of time overnight. She checked the temperature before she left for the day and when she arrived the next day the temperature was fine. It was a new refrigerator and there have not been any problems since the temperature excursion. No adverse reaction was experienced by the patient following the maladministration. No further information was provided. Follow up information received from the nurse on 26 Jan 2016: Reporter comment updated.
Age: 35.0
Sex: M
Vaccine: MMR
Symptoms: Erythema, Injection site pain, Rash, Rash erythematous, Rash macular
Clinical narrative: Patient advised he received MMR vaccine on 1/3/2017 because staff said he needed it. (medical record review documented only 1 MMR in 1999 in military medical records, no titers found). He advised the shot stung like a bee sting and 3-4 hours later he began to notice a fine dot like red rash to chest and abdomen with some red streaks like scratches on his torso. The rash was slight raised and itched. By 10 pm this rash has spread to his groin and thighs, arms. He took a BENADRYL and went to bed. Upon awakening this am (1/4/2017) he went to medical who sent to Immunization clinic and then to office. His rash is still has blanching blotchy red configuration, but is not raised and appears less red. He advised the rash did not extend to his face-head, feet, or hands. He has not started his oral typhoid pills so as not to confuse which vaccine was triggering the reaction. He denies any new food groups, detergents, soaps, chemical exposures, clothing, and no other systemic symptoms such as fever, pain, swelling, difficulty breathing, headaches, myalgia, arthralgia, et al. He is concerned because he has a 2 and year old at home and his wife is pregnant (less than 12 weeks). Symptoms: Rash, oth nonspecific skin eruption.
Age: 35.0
Sex: M
Vaccine: MMR
Symptoms: Rash pruritic
Clinical narrative: Patient advised he received MMR vaccine on 1/3/2017 because staff said he needed it. (medical record review documented only 1 MMR in 1999 in military medical records, no titers found). He advised the shot stung like a bee sting and 3-4 hours later he began to notice a fine dot like red rash to chest and abdomen with some red streaks like scratches on his torso. The rash was slight raised and itched. By 10 pm this rash has spread to his groin and thighs, arms. He took a BENADRYL and went to bed. Upon awakening this am (1/4/2017) he went to medical who sent to Immunization clinic and then to office. His rash is still has blanching blotchy red configuration, but is not raised and appears less red. He advised the rash did not extend to his face-head, feet, or hands. He has not started his oral typhoid pills so as not to confuse which vaccine was triggering the reaction. He denies any new food groups, detergents, soaps, chemical exposures, clothing, and no other systemic symptoms such as fever, pain, swelling, difficulty breathing, headaches, myalgia, arthralgia, et al. He is concerned because he has a 2 and year old at home and his wife is pregnant (less than 12 weeks). Symptoms: Rash, oth nonspecific skin eruption.
Age: 23.0
Sex: F
Vaccine: FLU3
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: Case number PHEH2015US026990, is an initial spontaneous report received from a nurse on 22 Dec 2015. This report refers to a 23 years old female patient. Medical history was not reported. Concomitant medication was not reported. The patient was vaccinated with FLUVIRIN (batch number: 1514501, expiry date: May 2016) into left deltoid on 06 Oct 2015. It was reported that before administration the FLUVIRIN had a temperature excursion of 34 degrees. The reporter stated that she did not know why the refrigerator was out of temperature range for an unspecified amount of time overnight. She checked the temperature before she left for the day and when she arrived the next day the temperature was fine. It was a new refrigerator and there have not been any problems since the temperature excursion. No adverse reaction was experienced by the patient following the maladministration. No further information was provided. Follow up information received from the nurse on 26 Jan 2016: Reporter comment updated.
Age: 36.0
Sex: F
Vaccine: FLU3
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: Case number PHEH2016US004975, is an initial spontaneous report received from a nurse on 25 Feb 2016. This report refers to 36 years old female patient. Past medical history and concomitant medications were not reported. The patient was vaccinated with FLUVIRIN (batch number: 157904 and expiry date: not reported) at a dose of 1 ml, intramuscularly on 23 Feb 2016. The reporter stated that, FLUVIRIN was administered after a temperature excursion of 1.4 degrees C (Celsius) for 1.5 hours. No adverse event was reported following this medication error.
Age: 44.0
Sex: F
Vaccine: FLU3
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: Case number PHEH2016US004977, is an initial spontaneous report received from a nurse on 25 Feb 2016. This report refers to 44 years old female patient. Past medical history and concomitant medications were not reported. The patient was vaccinated with FLUVIRIN (batch number: 157904) at a dose of 1 ml, intramuscularly on 23 Feb 2016. The reported stated that, FLUVIRIN was administered after a temperature excursion of 1.4 degrees C (Celsius) for 1.5 hours. The nurse assessed the case as non-serious. No adverse event was reported following this medication error (incorrect storage of drug).
Sex: U
Vaccine: FLU3
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: Case number PHEH2016US006847, is an initial spontaneous report received from a health care professional on 11 Mar 2016. The report refers to a patient of unknown age and gender. Past medical history and concomitant medication were not reported. The patient was vaccinated with FLUVIRIN (batch number: not reported) intramuscularly on 01 Feb 2016. It was reported that FLUVIRIN pre filled syringe were out of temperature range from 12.3 Celsius and the low was -3.4 Celsius, there were a few excursions noted on the temperature log and was unsure the exact number and total time. Registered nurse stated that, there might be one patient who received the vaccine after one of the excursions. No adverse event was reported following this medication error.
Sex: U
Vaccine: FLU3
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: Case number PHEH2015US025773, is an initial spontaneous report received from a health care professional on 07 Dec 2015. This report refers to a patient of an unknown age and gender. Medical history and concomitant medications were not reported. On an unknown date the patient was vaccinated with FLUVIRIN (batch number: not reported) that was left out at room temperature before administration. No adverse event was reported.
Sex: U
Vaccine: FLU3
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: Case number PHEH2016US017740 is an initial spontaneous report received from a pharmacist on 13 Jul 2016. This report refers to an unknown demographics patient. Medical history and concomitant medications were not reported. The patient was vaccinated with FLUVIRIN (batch number: unknown) at a dose of 0.5 ml on an unknown date. On an unspecified date, FLUVIRIN PFS went down to 29 degrees F for 3 days 15 hours and 14 minutes. The Vaccine was not frozen and had been administered. No patient/vaccine information available at this time. No adverse event was reported following this maladministration. Following an internal review done on 28 Jul 2016, for the data received on 13 Jul 2016: Significant case correction was performed. Changed the event coding inadvertent exposure to vaccine to incorrect product storage.
Sex: U
Vaccine: FLU3, MENB
Symptoms: Incorrect product storage
Clinical narrative: Case number PHEH2016US018308 is an initial spontaneous report received from nurse on 19 Jul 2016. This report refers to an unknown demographics patient. Medical history and concomitant medication were not reported. The patient was vaccinated with FLUVIRIN (batch number: 157804, expiry date: Apr 2016) at dose of 0.5 ml intramuscularly and BEXSERO (batch number: 151301C, expiry date: Dec 2016) intramuscularly in Apr 2016. In Apr 2016, throughout the month FLUVIRIN had several low temperature. The lowest excursion was 1.4 C for up to 5 hour and 18 minutes. Vaccine was not frozen. The reporter was not sure if the vaccine had been given since the first excursion in Apr 2016. The reporter states they usually did not give much vaccine after Mar, but reporter was not able to confirm that no one receive it and was unable to access the files to see if any vaccine had been given after the first excursion. The nurse reported that, no patients were given FLUVIRIN. The outcome of event was reported as unknown. The seriousness of event was reported as non serious. The causality of event was not reported. Follow up report received from a nurse on 20 Sep 2016: updated reporters comments.
Age: 30.0
Sex: F
Vaccine: FLU3
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: Case number PHEH2016US020879 is an initial spontaneous case received from pharmacist on 15 Aug 2016. This report refers to a 30 year old female patient. Medical history and concomitant medication was not reported. The patient was vaccinated with FLUVIRIN (manufacturer: unknown, batch number: 1619401) at a dose of 0.5 ml intramuscularly on 13 Aug 2016 which was stored at 32 F for up to 11 hour (open and unopened), and it was not frozen. The one vaccine had been administered and it was the first time excursion. No adverse event was reported following this medication error. Following internal review done on 02 Sep 2016, for the data received on 15 Aug 2016: Significant case correction was performed. Changed the suspect product coding FLUVIRIN which was wrongly coded.
Sex: F
Vaccine: FLU3
Symptoms: No adverse event, Underdose
Clinical narrative: Case number PHEH2016US021716 is an initial spontaneous report received from nurse on 25 Aug 2016. This report refers to female patient of an unknown age. Medical history and concomitant medications were not reported. The patient was vaccinated with FLUVIRIN (batch number: not reported) at a dose of 0.1 ml intramuscularly on 25 Aug 2016, prescribed dose was 0.5 ml and patient administered less than 0.1 ml. No adverse event was reported following this medication error (Vaccine underdose).
Sex: U
Vaccine: FLU3
Symptoms: Injection site joint pain
Clinical narrative: Case number PHEH2015US023947, is an initial spontaneous report from a health case professional (pharmacy student) received on 13 Nov 2015. This report refers to a patient of unknown identifies. Past medical history and concomitant medications were not reported. The patient received FLUVIRIN (batch number: not reported) intramuscularly in the shoulder joint on an unknown date. After vaccination the patient experienced pain in the shoulder joint area. The outcome, seriousness and causality of the event were not reported.
Sex: U
Vaccine: FLU3
Symptoms: No adverse event, Underdose
Clinical narrative: Case number PHEH2016US021750, is an initial spontaneous report received from a nurse on 25 Aug 2016. This report refers to a patient of an unknown age and unknown gender. Medical history was not reported. Concomitant medication was not reported. The patient received FLUVIRIN (batch number not reported) at a dose of 0.1 ml (underdose) on 25 Aug 2016. The patient was administered underdose. No adverse event was reported following the maladministration (vaccine underdose).
Age: 35.0
Sex: F
Vaccine: FLU3
Symptoms: Expired product administered, No adverse event
Clinical narrative: Case number PHEH2016US022047, is an initial spontaneous report received from a physician on 25 Aug 2016. This report refers to a 35-year-old female patient (out of 6 patients). Medical history was not reported. Concomitant medication was not reported. The patient was vaccinated with one single dose FLUVIRIN (batch number: 1517501, expiry date: Jun 2016) at a dose of 0.5 ml intramuscularly on 25 Aug 2016. No adverse event was reported following this maladministration.
Age: 23.0
Sex: F
Vaccine: FLU3
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: Case number PHEH2016US021760, is an initial spontaneous report received from a health care professional on 23 Aug 2016. This report refers to a 21-year-old female patient. Medical history was not reported. Concomitant medication was not reported. The patient was vaccinated with one single dose FLUVIRIN (batch number: 1619901, expiry date not reported) at a dose of 0.5 ml intramuscularly on 15 Aug 2016.No adverse event was reported following this maladministration (Incorrect product storage).
Sex: U
Vaccine: FLU3
Symptoms: No adverse event, Underdose
Clinical narrative: Case number PHEH2016US021840, is an initial spontaneous report received from a nurse on 25 Aug 2016. This report refers to a patient of unknown age and gender. Medical history and concomitant medications were not reported. The patient was vaccinated with FLUVIRIN (batch number: not reported) less than 0.1 ml intramuscularly on 25 Aug 2016 when the was prescribed with 0.5 ml. No adverse event was reported following this administration error.
Sex: U
Vaccine: FLU3
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: Case number PHEH2016US004385 is an initial spontaneous report received from a pharmacist on 18 Feb 2016. This report refers to a patient of unknown age and gender. Past medical history and concomitant medications were not reported. The patient was vaccinated with FLUVIRIN (batch number and expiry date: not reported) intramuscularly on 04 Feb 2016. The vaccine might have been used for the patient after the 1.1 C (Celsius) excursion for 1 hour and 39 minutes on 04 Feb 2016. On 16 Feb 2016, FLUVIRIN preservative free syringes reached 12.4 C for up to 1 hour and 36 minutes. No adverse event was reported following  this medication error (incorrect storage of drug).
Age: 78.0
Sex: F
Vaccine: FLU3
Symptoms: Inappropriate schedule of drug administration, No adverse event
Clinical narrative: Case number PHEH2016US004632, is an initial spontaneous report received from a health  care professional on 23 Feb 2016. This report refers to a 79 years old female patient. Medical history and concomitant medications were not reported. The patient received FLUVIRIN (batch number: 1515001) intramuscularly on 19 Oct 2015. It was reported that the patient inadvertently received a second dose of FLUVIRIN (batch number: 1515001) intramuscularly on 23 Feb 2016. No adverse event was reported.
Age: 61.0
Sex: F
Vaccine: HEP
Symptoms: Impaired work ability, Joint swelling, Nuclear magnetic resonance imaging, Oedema peripheral, Pain
Clinical narrative: Patient contacted agency on 12/22/2016 to review vaccine adverse event for VAERS (vaccine adverse event reporting system). She advised receiving her Hepatitis B vaccine (SKB lot #3P2XL) on 8/30/2016 and 20 minutes later she had a dull ache to the vaccine site. Over the next few days her pain got worse and she noticed some local site swelling and swelling to the top of her hand over the wrist and fingers. She didn't think much about this until 9/7/2016 when the pain started to radiate down her arm with right hand swelling. Pain occurs with movement. She sought medical care on 9/15/2016 for this reaction where HCP documented full ROM upper arm without redness, swelling or deformity. She did have generalized edema to the right hand. Rt shoulder exam normal with good ROM and strength. She was diagnosed with pain in right arm and treated with TYLENOL and steroid taper x 7 days. NSAIDS stopped. F/U on 9/19/2016 with Occ Health reports continued swelling to right hand/arm but was better. She still has pain along cubital nerve distribution which worsens with use of right hand. She was given Hydrocodone for pain and limited duty. F/U on 10/12/2016 reported hand swelling and pain better but continues. She C/O pain to right forearm with extension while lowering her arm which improves when arm placed over chest (flexing at elbow). Her exam showed tenderness to subacromial bursa and she was treated with steroid dose pack and sling. SM F/U with HCP doctor on 12/20/2016-1/4/2017 for MRI of shoulder and advised she went to hospital to R/O PE in arm. Results are unknown to this provider.
Age: 61.0
Sex: F
Vaccine: HEP
Symptoms: Pain in extremity, Peripheral swelling, Tenderness, Vaccination site pain, Vaccination site swelling
Clinical narrative: Patient contacted agency on 12/22/2016 to review vaccine adverse event for VAERS (vaccine adverse event reporting system). She advised receiving her Hepatitis B vaccine (SKB lot #3P2XL) on 8/30/2016 and 20 minutes later she had a dull ache to the vaccine site. Over the next few days her pain got worse and she noticed some local site swelling and swelling to the top of her hand over the wrist and fingers. She didn't think much about this until 9/7/2016 when the pain started to radiate down her arm with right hand swelling. Pain occurs with movement. She sought medical care on 9/15/2016 for this reaction where HCP documented full ROM upper arm without redness, swelling or deformity. She did have generalized edema to the right hand. Rt shoulder exam normal with good ROM and strength. She was diagnosed with pain in right arm and treated with TYLENOL and steroid taper x 7 days. NSAIDS stopped. F/U on 9/19/2016 with Occ Health reports continued swelling to right hand/arm but was better. She still has pain along cubital nerve distribution which worsens with use of right hand. She was given Hydrocodone for pain and limited duty. F/U on 10/12/2016 reported hand swelling and pain better but continues. She C/O pain to right forearm with extension while lowering her arm which improves when arm placed over chest (flexing at elbow). Her exam showed tenderness to subacromial bursa and she was treated with steroid dose pack and sling. SM F/U with HCP doctor on 12/20/2016-1/4/2017 for MRI of shoulder and advised she went to hospital to R/O PE in arm. Results are unknown to this provider.
Age: 28.0
Sex: M
Vaccine: FLU3
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: Case number PHEH2015US026967 is a spontaneous report initially received from a nurse on 22 Dec 2015. This report refers to a 28-year-old male patient. Medical history was not reported. Concomitant medication was not reported. The patient was vaccinated with FLUVIRIN (batch number: 1514501, expiry date: May 2016) into left deltoid on 08 Oct 2015. It was reported that FLUVIRIN administered to the patient had a temperature excursion of 34 degrees. The reporter stated that she did not know why the refrigerator was out of temperature range for an unspecified amount of time overnight. She checked the temperature before she left for the day and when she arrived the next day and the temperature was fine. It was new refrigerator and there were no problems since the temperature excursion. No adverse reaction was experienced by the patient following the maladministration. Follow up information received via nurse on 26 Jan 2016: Reporter's comments updated.
Age: 37.0
Sex: F
Vaccine: FLU4
Symptoms: Injection site pain, Joint range of motion decreased, X-ray limb normal
Clinical narrative: LPN in clinic presented with continued complaints of left shoulder pain. She reported receiving her annual influenza vaccine on 9/12/2016 to her left deltoid. (SKB Lot CS979). She advised a few moments later her shoulder began to ache and burn. The burning resolved within a few moments but she had a persistent dull ache and over the next week she noted issues with ROM to her arm, pain on lifting and extending. She advised her left upper third of deltoid was tender to palpation, there was no fever, swelling, site redness or trauma to area. She is right handed. She has been limiting use of her arm and has tried periodic use of NSAID 400 mg 1-2 times a day with minimal relief pain. She mention this issue to co-workers who recommended she seek further treatment. She completed course of oral steroids, use of warm/heat therapy and physical therapy and as of Jan 2017 symptoms have improved 99%.