chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Sex: F
Vaccine: ANTH
Symptoms: Insomnia, Mobility decreased, Pain in extremity
Clinical narrative: Information received on 07MAY2013 from a pharmaceutical company on behalf of a consumer who reported an adverse experienced via social media. A female experienced pain, causing difficulty in sleep, and decreased limb mobility following immunization with ANTHRAX vaccine. On an unspecified date, the female received dose 2 of ANTHRAX vaccine (site, route, lot number not reported). Reportedly, 36 hours after immunization the patient experienced pain in the arm that was keeping her awake. She reported that she could barely lift her arm. She stated that she had barely noticed the first dose of ANTHRAX vaccine, and questioned what she or the administrator had done differently for the 2nd dose. No further information was reported.
Sex: M
Vaccine: ANTH
Symptoms: Spondylitis
Clinical narrative: A phone call was received from a reporter at a college. The reporter was covering a news story of a male service member of the military who received immunization with "Anthrax vaccine" and subsequently experienced spondylitis. No further information is available.
Age: 24.0
Sex: F
Vaccine: ANTH
Symptoms: Dizziness, Headache, Nausea, Vomiting, White blood cell count increased
Clinical narrative: Spontaneous report received on 22MAR2013 and 25MAR2013. An immunization nurse reported that a 24 year old female patient experienced headache, dizziness, nausea and vomiting. On 19MAR2013 15:23 pm, the female received dose 3 of BioThrax (FAV439) intramuscularly in the left deltoid. On 20MAR2013, she developed a headache with some dizziness. On 21MAR2015 she experienced nausea with vomiting; the headache with dizziness continued. She treated with symptoms with TYLENOL and GATORADE. On 22MAR2013, symptoms continued and she was seen in the emergency room where she was treated with ZOFRAN and intravenous fluids. Laboratory testing revealed an elevated white blood cell count. She was discharged several hours later, and subsequently the nausea resolved, however, the headache and dizziness continued. On 25MAR2013, all events were considered resolved. Of note, the patient had a recent history of left ankle fracture with surgical repair and continued pain. At the time of immunization, she was non-weight bearing with crutches, and on treatment with ULTRAM and ARTHROTEC for pain and inflammation.
Age: 27.0
Sex: F
Vaccine: ANTH
Symptoms: Injection site erythema, Injection site induration, Injection site pain, Injection site pruritus, Injection site swelling
Clinical narrative: Spontaneous report received on 23JAN2013 from a company representative. On 22JAN2013 a 27 year old female received dose B of Bio Thax intramuscularly in the left arm (FAV439). On 23JAN2013 she complained of itching, redness, induration, pain, and swelling at the injection site. She treated her symptoms with 25 mg of BENADRYL. She reports that all symptoms received and she has recovered as of 30JAN2013.
Sex: F
Vaccine: ANTH
Symptoms: Injection site reaction, Local reaction
Clinical narrative: Spontaneous report received on 14JAN2013 from a female company employee. The female reported that she experienced a large local reaction at the injection site following immunization with BIOTHRAX. Subsequently, she recovered, but declined further immunization with BIOTHRAX due to the reaction. No further information is expected at this time.
Age: 44.0
Sex: M
Vaccine: ANTH
Symptoms: Abdominal pain, Diarrhoea, Headache, Nausea, Pain
Clinical narrative: Information received from a nurse on behalf of consumer on 25NOV2013. A 44 year old male experienced headache, body aches, abdominal pain, and diarrhea. On 28OCT2013, the male received dose 15 of BIOTHRAX (Lot FAV429) intramuscularly in the right deltoid. Three days later, on 31OCT2013, he experienced nausea with headache, body aches, abdominal pain and diarrhea. The symptoms lasted approximately 24 hours, and on 01NOV2013 were considered resolved. The patient noted that he had experienced nausea and fatigue following dose 11 with BIOTHRAX.
Age: 32.0
Sex: F
Vaccine: ANTH
Symptoms: Body temperature increased, Ear swelling, Eye irritation, Eye swelling, Fatigue
Clinical narrative: Information received on 25OCT2013 from a consumer. A 32 year old female experienced a possible allergic reaction. On 23OCT2013; 11:30 AM the female received dose 3 of BIOTHRAX (FAV429) intramuscularly in the left deltoid. That evening, her left arm felt tender and hard at injection site. No redness, itching, or decreased range of motion was noted. On 25 Oct 2013 she awoke with irritation and puffiness around right eye; no redness or sclera was noted. That evening, she felt exhausted and went to bed at 8:00 pm. She awoke at 1:00 am. with increased swelling around eyes and ears; right side greater than left. Additionally her scalp felt itchy, and she noticed hives / itching on lower abdomen, right wrist and left arm. No pain was noted, but the swollen areas felt warm to touch.  She went to the local Emergency Department and her temperature was noted to be 99.8. She was told that she had "a reaction to something: possibly vaccine". It is noted that there were no identifiable cause of her symptoms. She had no prior vaccine allergy history, but was noted to have had a possible past penicillin allergy. She was treated with BENADRYL and prednisone. By 26OCT2013 the swelling had decreased. On 27OCT2013, all symptoms had resolved.
Age: 32.0
Sex: F
Vaccine: ANTH
Symptoms: Injection site induration, Injection site pain, Middle insomnia, Pruritus, Skin warm
Clinical narrative: Information received on 25OCT2013 from a consumer. A 32 year old female experienced a possible allergic reaction. On 23OCT2013; 11:30 AM the female received dose 3 of BIOTHRAX (FAV429) intramuscularly in the left deltoid. That evening, her left arm felt tender and hard at injection site. No redness, itching, or decreased range of motion was noted. On 25 Oct 2013 she awoke with irritation and puffiness around right eye; no redness or sclera was noted. That evening, she felt exhausted and went to bed at 8:00 pm. She awoke at 1:00 am. with increased swelling around eyes and ears; right side greater than left. Additionally her scalp felt itchy, and she noticed hives / itching on lower abdomen, right wrist and left arm. No pain was noted, but the swollen areas felt warm to touch.  She went to the local Emergency Department and her temperature was noted to be 99.8. She was told that she had "a reaction to something: possibly vaccine". It is noted that there were no identifiable cause of her symptoms. She had no prior vaccine allergy history, but was noted to have had a possible past penicillin allergy. She was treated with BENADRYL and prednisone. By 26OCT2013 the swelling had decreased. On 27OCT2013, all symptoms had resolved.
Age: 32.0
Sex: F
Vaccine: ANTH
Symptoms: Urticaria
Clinical narrative: Information received on 25OCT2013 from a consumer. A 32 year old female experienced a possible allergic reaction. On 23OCT2013; 11:30 AM the female received dose 3 of BIOTHRAX (FAV429) intramuscularly in the left deltoid. That evening, her left arm felt tender and hard at injection site. No redness, itching, or decreased range of motion was noted. On 25 Oct 2013 she awoke with irritation and puffiness around right eye; no redness or sclera was noted. That evening, she felt exhausted and went to bed at 8:00 pm. She awoke at 1:00 am. with increased swelling around eyes and ears; right side greater than left. Additionally her scalp felt itchy, and she noticed hives / itching on lower abdomen, right wrist and left arm. No pain was noted, but the swollen areas felt warm to touch.  She went to the local Emergency Department and her temperature was noted to be 99.8. She was told that she had "a reaction to something: possibly vaccine". It is noted that there were no identifiable cause of her symptoms. She had no prior vaccine allergy history, but was noted to have had a possible past penicillin allergy. She was treated with BENADRYL and prednisone. By 26OCT2013 the swelling had decreased. On 27OCT2013, all symptoms had resolved.
Age: 20.0
Sex: F
Vaccine: ANTH, TYP
Symptoms: Expired product administered
Clinical narrative: Information received from a nurse on 29AUG2013 regarding a 33 year old female who was administered expired vaccine without adverse event. On 28AUG2013 the female received a primary dose of BIOTHRAX (Lot FAV308; exp. 14AUG2013) and a primary dose of Typhoid vaccine both intramuscularly in an unspecified arm. It was later noted, that the BIOTHRAX had exceeded its expiry date at the time of administration. There were no reported associated adverse events.
Sex: U
Vaccine: RV1
Symptoms: Wrong technique in drug usage process
Clinical narrative: This case was reported by a nurse via sales rep and described the occurrence of inappropriate preparation of medication in a unk patient who received ROTARIX (batch number A41CB4464, expiry date 30th January 2016). On 14th October 2014, the patient received ROTARIX (oral). On 14th October 2014, an unknown time after receiving ROTARIX, the patient experienced inappropriate preparation of medication. On an unknown date, the outcome of the inappropriate preparation of medication was unknown. Additional information received: RN reported to Account Manager that 5 patients had inadvertently received only the diluent portion of the ROTARIX vaccine. All five patients returned to the physician office that day to received the vaccine and diluent product. No AE's were reported. It is thought that one child may have been 2 months old, it is unknown if any had received ROTATEQ previously as the office was changing over Vaccine manufacturers.
Age: 1.1
Sex: U
Vaccine: PNC
Symptoms: Cochlea implant, Meningitis
Clinical narrative: This is a spontaneous report from a contactable nurse via a Pfizer sales representative. A 13-month-old patient of unknown gender and ethnicity received PREVNAR via an unknown route of administration in Mar2003. Relevant medical history, relevant sibling information, and concomitant medications were unknown. Vaccines that may have been given on the same day and/or within the last four weeks were unknown. In Mar2004, the patient experienced meningitis. Relevant therapeutic measures in response to the event meningitis included cochlear implants. Relevant lab data was unknown. The clinical outcome of the event meningitis was unknown. Subsequently, a contactable physician reported being unable to confirm the occurrence of the event meningitis and was unable to provide information. Follow-up (24Jun2013): New information reported from a contactable physician includes: No new information; physician unable to confirm event meningitis. Follow-up attempts completed. No further information expected.
Age: 78.0
Sex: F
Vaccine: PNC
Symptoms: Abdominal pain, Fatigue, Myalgia, Nausea
Clinical narrative: This is a spontaneous report from a contactable physician. A 78-year-old female patient of an unspecified ethnicity started to receive LIPITOR, epinephrine (unspecified manufacturer), codeine (unspecified manufacturer), sulfa, ZOCOR, and ZETIA; all via an unspecified route of administration from an unspecified date, at an unspecified dose and frequency, for an unspecified indication. The patient medical history was not reported. The patient's concomitant medications were not reported. The patient was allergic to atorvastatin calcium, codeine, sulfa, epinephrine, simvastatin, ezetimibe on an unspecified date. Upon follow-up on 11Dec2012, the physician further reported that the patient is reported to have various reactions ranging from fatigue to myalgias to abdominal pain to nausea from the others listed, none of which were serious. The action taken in response to the events for atorvastatin calcium, epinephrine, codeine, sulfa, simvastatin and ezetimibe was unknown. As of 11Dec2012, the outcome of the events was unknown. On 26Feb2013, the physician reported that the patient was also allergic to NORVASC, lisinopril, PREVNAR, COZAAR, VICODIN and HIDROLASE. Pfizer is the Marketing Authorization Holder of epinephrine in the reporter's country. This may be a duplicate report in situations where another Marketing Authorization Holder of epinephrine has submitted the same report to the regulatory authorities. Follow-up (11Dec2012): Follow-up attempts completed. No further information expected. Follow-up (11Dec2012): New information reported from the same contactable physician included: reaction data (added events "fatigue", "myalgia", "abdominal pain", "nausea" with seriousness assessment). Follow-up (07-FEB-2013): Follow-up attempts completed. No further information expected. Follow-up (26Feb2013): New information received from a contactable physician stated that: patient was also allergic to NORVASC, lisinopril, PREVNAR, enalapril, COZAAR, VICODIN and HIDROLASE. Follow-up attempts completed. No further information expected.
Age: 25.0
Sex: F
Vaccine: FLU3
Symptoms: Incorrect route of drug administration, Injection site erythema, Injection site pain, Injection site swelling
Clinical narrative: Case number PHEH2013US022999 is an initial spontaneous report received from a nurse on 31 OCT 2013. This report refers to a 25-yera-old female patient. On 30 OCT 2013, she was vaccinated with FLUVIRIN 2013/2014 (batch number 13461P, expiry date: May 2014) subcutaneously. On 31 OCT 2014, she developed burning, redness and swelling at the injection site and received Benadryl 25 mg orally. Outcome of the events was unknown. No seriousness and causality was reported for the events.    After an internal review on 15 NOV 2013, it was identified that labeling of the event "FLUVIRIN received subcutaneously" was erroneously assesed as listed. Hence significant was done and labeling was changed to unlisted.
Age: 72.0
Sex: M
Vaccine: FLU3
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: Case number PHEH2013US021636 is an initial spontaneous report received from a health care professional (laboratory technician) on 15 OCT 2013, with a follow-up received on 13 NOV 2013. This report refers to a 72-years-old male patient. His medical history and concomitant medications were not reported. He was vaccinated with FLUVIRIN 2013/2014 (batch number 1309001, expiry date: APR 2014) intramuscularly at a dose of 0.5 ml on 07 OCT 2013. It was reported that the vaccine he received was stored in room temperature for up to 24 hours. It was reported that the patient had no adverse event following the maladministration.   Follow-up was received on 13 NOV 2013: Information that patient had no adverse reaction was updated.
Age: 55.0
Sex: F
Vaccine: FLU3
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: Case number PHEH2013US021669 is an initial spontaneous report from nurse received on 16 OCT 2013, with a follow-up received on 11 NOV 2013. This case refers to a 55-year-old female patient. She received FLUVIRIN 2013/2014 (batch number: 13395P) at a dose of 0.5 ml intramuscularly into left deltoid on 16 OCT 2013. The nurse stated that patient received FLUVIRIN from pre filled syringes that had temperature excursion of 54 F for 8 hours (refrigerator had been out of range). No adverse event was reported following medication error. The seriousness and causality of event was not reported.  Follow-up received was received on 11 NOV 2013: Batch number, vaccination site, other clinical information and information that patient had no adverse event was updated.
Age: 2.0
Sex: F
Vaccine: FLU3
Symptoms: Incorrect product storage
Clinical narrative: Case number PHEH2013US021651 is an initial spontaneous report from physician received on 16 OCT 2013 with a follow-up received fr om the physician on 08  NOV 2013. This case refers to 2-year-old female patient. She received FLUVIRIN 2013/2014 (batch number: 1308801 and expiry date: APR 2014) intramuscularly on an unknown date. The physician stated that patient received FLUVIRIN that had been pre-dawn from multidose vials into syringes and left at room temperature. No specific dates of occurrence provided. The seriousness and causality of event was not reported.   Follow-up received from the physician on 08 NOV 2013. Updated batch number and expiry date of FLUVIRIN.
Age: 60.0
Sex: F
Vaccine: FLU3
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: Case number PHEH2013US021754 is an initial spontaneous report from pharmacist received on 17 OCT 2013 with a follow up received on 17 DEC 2013. This case refers to a 60 year old female patient. Her vaccination history included administration of flu vaccines in the past that were tolerated well. She was vaccinated with FLUVIRIN 2013/2014 (batch number: 1309401, expiry date: APR 2014) at 0.5 ml intramuscularly into right deltoid on 16 OCT 2013. The pharmacist stated that she received FLUVIRIN that had been pre-drawn from multidose vial, held out for approximately 15 minutes and then administered. The seriousness and causality of event was not reported. No adverse event was reported due to medication error.  Follow-up was received from the pharmacist on 17 DEC 2013: Updated vaccination history of the patient and site of administration of FLUVIRIN.
Age: 32.0
Sex: F
Vaccine: FLU3
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: Case number PHEH2013US021671 is an initial spontaneous report from nurse received on 16 OCT 2013 and a follow up report from the nurse received on 11 NOV 2013. This case refers to an adult female patient. She received FLUVIRIN 2013/2014 (batch number: 13395P), 0.5 ml intramuscularly in the left deltoid on 15 OCT 2013. The nurse stated that patient received FLUVIRIN from pre filled syringes that had temperature excursion of 54 F for 8 hours. No adverse event reported following this medication error.  Follow up report from the nurse received on 11 NOV 2013. Site of vaccination and batch number of FLUVIRIN vaccine were updated.
Age: 82.0
Sex: F
Vaccine: FLU3
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: Case number PHEH2013US012757 is an initial spontaneous report from pharmacist received on 17 OCT 2013 with a follow up received on 17 DEC 2013. This case refers to an 82 year old female patient. Her vaccination history included administration of flu vaccines in the past that were tolerated well. She received FLUVIRIN 2013/2014 (batch number: 1309401, Expiry date: APR 2014) at 0.5 ml intramuscularly into right deltoid on 16 OCT 2013. The pharmacist stated that she received FLUVIRIN that had been pre-drawn from multidose vial, held out for approximately 15 minutes and then administered. The seriousness and causality of event was not reported. No adverse was reported due to medication error.  Follow-up was received on 17 DEC 2013: Updated vaccination history of the patient and site of administration of FLUVIRIN.
Age: 31.0
Sex: F
Vaccine: FLU3
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: Case number PHEH2013US020530 is an initial spontaneous report received from a nurse on 30 SEP 2013 and a follow up report received from the nurse on 14 JAN 2014. This report refers to a 31-years-old female patient. Her medical history and concomitant medications were not reported. She was vaccinated with a 0.5 ml intramuscular dose of FLUVIRIN 2013/2014 (batch number: 1308401, expiry date: MAR 2014) which was placed room temperature on 26 SEP 2013 in deltoid. It was reported that the nurse was not there when the shipment arrived and it was placed on desk and hence the vaccine in shipping container  was placed in room temperature for 72  hours. No adverse event was reported following the medication error.  Follow up report received from the nurse on 14 JAN 2014: FLUVIRIN vaccination site was updated.
Age: 24.0
Sex: F
Vaccine: FLU3
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: Case number PHEH2013US020538 is an initial spontaneous report from the nurse received on 30 SEP 2013 and a follow up report from the nurse received on 04 FEB 2014. This report refers to a 24-year-old female patient. She was vaccinated with FLUVIRIN 2013/2014 (batch number: 1308401, expiry date: MAR 2014) at a dose of 0.5 ml via intramuscular route in the deltoid muscle on 27 SEP 2013. It was reported that the vaccine which was given to the patient was stored at room temperature during shipment for 72 hours. No adverse event reported following this medication error.  Follow up report from the nurse received on 04 FEB 2014: Site of vaccination was updated.
Age: 31.0
Sex: F
Vaccine: FLU3
Symptoms: Exposure during pregnancy, No adverse event
Clinical narrative: Case number PHEH2013US001678, is an initial spontaneous report received from a pharmacist on 16 JAN 2013. This case refers to a 31-year-old female patient. Her medical history and concomitant medication were not reported. During her pregnancy, she was vaccinated with FLUVIRIN 2012/2013 (batch number: 1206101) intramuscularly on 16 JAN 2013. No adverse event was reported after vaccine exposure during pregnancy.  31 MAR 2014: Multiple attempts have been made to obtain follow-up information and outcome of pregnancy event without success. This case is considered lost to follow-up.
Age: 34.0
Sex: F
Vaccine: FLU3, TDAP
Symptoms: Exposure during pregnancy, Medication error
Clinical narrative: Case number PHEH2013US023320 is an initial spontaneous report received from a nurse on 01 NOV 2013 with the follow-up received on 20 FEB 2014. This report refers to a 34-year-old female patient. Her medical history included depression, intrauterine growth restriction at 31 weeks on 06 JUL 2013 and normal spontaneous vaginal delivery. Concomitant medication included azithromycin for upper respiratory infection and prenatal vitamins during entire pregnancy. She was vaccinated  with 0.5 ml of FLUVIRIN 2013/2014 (batch number: unknown) intramuscularly into left upper arm on 30 OCT 2013 at 9:00 AM when she was pregnant for 28 weeks of gestation. On the same day, she was also vaccinated with TDAP (manufacturer and batch number unknown). One week before prior to this flu vaccination, she was also vaccinated with an intramuscular dose of FLUVIRIN 2013/2014 (batch number: unknown). The patient was already receiving frequent ultrasounds due to intrauterine growth restriction which she also had a history with her prior pregnancy. The patient did not experience any adverse reactions as proven into the continuation of her pregnancy. On an unknown date at her 37 weeks of gestation, she had a precipitous labor (<3 hours) and delivered a normal male baby. Nurse assessed the causality as not suspected. No additional information was available.   Follow-up received from a nurse on 20 FEB 2014: Patients demographics, medical history, concomitant medications and vaccinations details were updated.
Sex: F
Vaccine: FLU3
Symptoms: Exposure during pregnancy
Clinical narrative: Case number PHEH2012US022254 is an initial spontaneous report received from a physician on 07 NOV 2012 with a follow up information received on 15 JAN 2014. This case refers to female pregnant patient of unspecified age. She was vaccinated with FLUVIRIN 2012/2013 (batch number: not reported) intramuscularly on 06 NOV 2012. Upon follow up information received on 15 JAN 2014, it was reported that multiple attempts were made to obtain further information and outcome of pregnancy, but without success. The case was hence considered as a lost to follow up. No further information was reported.   Follow up information received on 15 JAN 2014. Lost to follow-up information updated.
Age: 66.0
Sex: F
Vaccine: FLU3
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: Case number PHEH2013US020529 is an initial spontaneous report received from a nurse on 30 SEP 2013 with a follow up information received from a nurse on 04 FEB 2014. This report refers to a 66-years-old female patient. On 26 SEP 2013, she was vaccinated with FLUVIRIN 2013/2014 (batch number: 1308401, expiry date: MAR 2014) at a dose of 0.5 ml intramuscularly in the deltoid. It was reported that before vaccination. FLUVIRIN was placed in the shipping container at room temperature for 72 hours and later administered to the patient (incorrect storage of vaccine). No adverse event was reported following this medication error.  Follow up information received from a nurse on 04 FEB 2014: Site of vaccination updated.
Age: 34.0
Sex: F
Vaccine: FLU3
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: Case number PHEH2013US020541 is an initial spontaneous report received from a nurse on 30 SEP 2013 with a follow-up received from the nurse on 14 JAN 2014. This report refers to a 34-year-old female patient. On 27 SEP 2013, she was vaccinated intramuscularly with FLUVIRIN 2013/2014 (batch number: 1308401, expiry date: MAR 2014) at a dose of 0.5 ml. It was reported that before vaccination. FLUVIRIN 2as placed in the shipping container at room temperature for 72 hours and later administered to the patient (incorrect storage of vaccine). It was reported that the vaccine was not refrigerated immediately when it arrived at the practice. No adverse event was reported following this medication error.  Follow-up received from the nurse on 14 JAN 2014: Updated dose of FLUVIRIN and comment from the reporter.
Age: 101.0
Sex: F
Vaccine: FLU3
Symptoms: Drug administered to patient of inappropriate age, No adverse event
Clinical narrative: Case number PHEH2013US023018 is an initial spontaneous report received from a pharmacist on 31 OCT 2013 and a follow up report from the pharmacist received on 26 NOV 2013. This report refers to a 101-year-old female patient. It was reported that previously she was vaccinated with influenza vaccine and tolerated it well. She was vaccinated with a seasonal influenza vaccine (manufacturer and batch number: unknown) on an undetermined date in SEP 2013 and with FLUVIRIN 2013/2014 (batch number unknown) on 29 OCT 2013. No adverse event was reported following this administration error (inappropriate schedule of vaccine administered).  Follow-up was received on 26 NOV 2013: Vaccination history was updated.
Age: 58.0
Sex: M
Vaccine: FLU3
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: Case number PHEH2013US020532 is an initial spontaneous report received from a nurse on 30 SEP 2013 with a follow up information received from a nurse on 14 JAN 2014. This report refers to a 58-years-old male patient. His medical history and concomitant medications were not reported. It was reported that FLUVIRIN was tolerated in the past. He was vaccinated with 0.5 ml intramuscular dose of FLUVIRIN 2013/2014 (batch number: 1308401, expiry date: MAR 2014) in the deltoid on 26 SEP 2013. The vaccine was placed room temperature. It was reported that the nurse was not there when the shipment arrived and it was placed on desk and  hence the vaccine in shipping container was placed in room temperature for less than 72 hours. No adverse event was reported following the medication error.  Follow up information received from a nurse on 14 JAN 2014: Vaccination history and site of vaccination updated.
Age: 25.0
Sex: F
Vaccine: FLU3
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: Case number PHEH2013US020531 is an initial spontaneous report received from a nurse on 30 SEP 2013 with a follow up information received from a nurse on 04 FEB 2014. This report refers to a 25-years-old female patient. Her medical history and concomitant medications were not reported. She was vaccinated with 0.5 ml intramuscular dose of FLUVIRIN 2013/2014 (batch number: 1308401, expiry date: MAR 2014) in the deltoid on 27 SEP 2013. It was reported that the nurse was not there when the shipment arrived and it was placed on desk and hence the vaccine is shipping container was placed in room temperature for 72 hours. No adverse event was reported following the medication error.  Follow up medication received from a nurse on 04 FEB 2014: Vaccination date and site of vaccination updated.
Age: 81.0
Sex: F
Vaccine: FLU3
Symptoms: Injection site extravasation, Underdose
Clinical narrative: Case number PHEH2013US022485 is an initial spontaneous report from pharmacist received on 24 OCT 2013 with a follow up information received from a pharmacist on 19 NOV 2013. This case refers to an 81-years-old female patient. She was vaccinated with FLUVIRIN 2013/2014 (batch number: 1303501) intramuscularly on 18 SEP 2013. While FLUVIRIN administration , some of the vaccine oozed out at the injection site. The patient claimed that she felt liquid droplet came out of injection site. No adverse event was reported following this administration error.  Follow up information received from a pharmacist on 19 NOV 2013: Batch number, dose and date of vaccination updated.
Age: 3.0
Sex: M
Vaccine: FLU3
Symptoms: Drug administered to patient of inappropriate age, No adverse event
Clinical narrative: Case number PHEH2013US022230 is an initial spontaneous report received from a nurse on 21 OCT 2013, with the follow-up received on 18 NOV 2013. This report refers to a 3-year old months old male child who was inadvertently vaccinated initially with FLUVIRIN 2013/2014 (batch number: 13445P and expiry date: May 2015) at a dose of 0.5 ml intramuscularly on 18 OCT 2013 at 11:45 AM. It was reported that, he had not well visited to the clinic. No adverse event was reported following this administration error.  Follow-up received from nurse on 18 NOV 2013: Updated vaccination time and reporter comments.
Age: 3.0
Sex: M
Vaccine: FLU3
Symptoms: Drug administered to patient of inappropriate age, No adverse event
Clinical narrative: Case number PHEH2013US022227 is an initial spontaneous report received from a nurse on 21 OCT 2013, with the follow-up received on 18 NOV 2013. This report refers to a 3-year old female child who was inadvertently vaccinated with FLUVIRIN 2013/2014 (batch number: 13445P and expiry date: May 2015) at 0.5 ml intramuscularly in the left thigh on 20 OCT 2013 at 12:00. No adverse event was reported following this administration error.  Follow-up received from nurse on 18 NOV 2013: Updated patient height and weight, vaccination time, date and site.
Sex: M
Vaccine: FLU3
Symptoms: No adverse event, Underdose, Wrong technique in drug usage process
Clinical narrative: Case number PHEH2013US022170 is an initial spontaneous report received from a pharmacist on 18 OCT 2013 with a follow-up received on 16 DEC 2013. This report refers to an adult male patient. His medical history was not reported. He was vaccinated with FLUVIRIN 2013/2014 (batch number: 13375P) intramuscularly into left deltoid on 18 OCT 2013 at 10:00 am. The pharmacist stated that during administration of FLUVIRIN, the needle was not attached properly and subsequently vaccine spilled out of syringe and on to the patient's arm. Pharmacist mentioned that the patient did not receive full dose of the vaccine. Upon follow-up the pharmacist stated that there was no adverse events occurred just had malfunction with needle dispending medication. No additional information was available.  Follow-up received from a pharmacist on 16 DEC 2013: Site and time of vaccination administered and reporter's comment was updated.
Age: 40.0
Sex: F
Vaccine: FLU3
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: Case number PHEH2013US020540 is an initial spontaneous report from the nurse received on 30 SEP 2013 with a follow-up received on 25 FEB 2014. This report refers to a 40-year-old female patient. She was vaccinated with FLUVIRIN 2013/2014 (batch number: 1308401, expiry date: Mar 2014) at a dose of 0.5 ml via intramuscular route into deltoid on 27 SEP 2013. It was reported that the vaccine which was given to the patient was stored at room temperature during shipment for 72 hours. No adverse event reported following this medication error.  Follow-up received from a nurse on 25 FEB 2014: Site of vaccination updated.
Age: 46.0
Sex: F
Vaccine: FLU3
Symptoms: Hypoaesthesia, Injection site nerve damage, Injection site pain, Paraesthesia
Clinical narrative: Case number PHEH2013US020555 is an initial spontaneous report received from a pharmacist on 30 SEP 2013, with a follow-up received on 19 NOV 2013. This report refers to a 46-year-old female patient. She had beginning stage os MS (multiple sclerosis). This poly medicated patient was vaccinated with FLUVIRIN 2013/2014 (batch number: 1309401, expiry date: APR 2014) intramuscularly in her left deltoid on 30 SEP 2013. On the same day after vaccination, she experienced a burning pain at the injection site along with a tingling numbness in her arm and hand. She did not receive any medical care for these events. She was monitored by the physician who concluded that a nerve was probably hit. She was recovered from this event a day later. Final outcome of all the events was recovered. No causality and seriousness were reported.   Follow-up was received on 19 NOV 2013: Medical history, concomitant medication, expiry date and dose of vaccine, event (nerve was probably hit) and outcome were updated.
Age: 24.0
Sex: F
Vaccine: FLU3
Symptoms: Exposure during pregnancy, Hypoaesthesia, Peripheral swelling
Clinical narrative: Case number PHEH2013US020558 is an initial spontaneous report received from a physician on 01 OCT 2013. This report refers to a 24-year-old pregnant female patient. She was 23 weeks pregnant when she was vaccinated with FLUVIRIN 2013/2014 (batch number: 1308701) intramuscularly on 01 OCT 2013. After administration, she experienced slight swelling and numbness in the fingers. No medical care was provided till the time of reporting. No further information was available.  01 MAY 2014: Multiple attempts have been made to obtain follow-up information and outcome of pregnancy event without success. This case is considered lost to follow-up.
Age: 3.0
Sex: F
Vaccine: FLU3
Symptoms: Drug administered to patient of inappropriate age, No adverse event
Clinical narrative: Case number PHEH2013US020750 is an initial spontaneous report from a health care professional received on 02 OCT 2013, with a follow-up received on 18 NOV 2013. This report refers to a 03-year-old female child.  No medical history and concurrent conditions were reported. No concomitant medications were reported. The reporter stated that this 03 year old child inadvertently administered FLUVIRIN 2013/2014 (batch number: 13401P) at a dose of 0.5 ml intramuscularly into left thigh on 27 SEP 2013 at 12:00. No adverse reaction was experienced by the patient after this medication error.  Follow-up was received on 18 NOV 2013: Patient demographics, vaccination dose, vaccination site and time and information that no adverse reaction was experienced were updated.
Age: 56.0
Sex: M
Vaccine: FLU3
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: Case number PHEH2013US021455 is an initial spontaneous report from the pharmacist received on 11 OCT 2013, with a combined follow-up received on 03 DEC 2013. This report refers to a 56-year-old  male patient. He was vaccinated with FLUVIRIN 2013/2014 (batch number: 1309301( at a dose of 0.5 ml intramuscularly into left arm on 11 OCT 2013 at 09:30 AM. It was reported that the FLUVIRIN received by the patient was left at a temperature of 47 F overnight because the refrigerator was not closed properly. Patient was doing well and had no adverse event following this medication error (incorrect storage of vaccine).  Follow up was received on 03 DEC 2013: Vaccination information (time, site and dose) and information that patient had no adverse event were updated.
Age: 2.0
Sex: F
Vaccine: FLU3
Symptoms: No adverse event, Wrong drug administered
Clinical narrative: Case number PHEH2013US021531 is an initial spontaneous report received from a nurse on 14 Oct 2013 with a follow up information received from a nurse on 11 Nov 2013. This report refers to a 2-years-old female patient. Her medical history and concomitant medications were not reported. She was inadvertently vaccinated with an intramuscular dose of FLUVIRIN (batch number: 1308501) at a dose of 0.5 ml in the thigh on 10 Oct 2013. It was reported that the patient was administered 0.5 ml FLUVIRIN instead of 0.25 ml FLUZONE (other manufacturer, batch number: not reported). The physician was informed. No adverse event was reported following the maladministration. Follow up information received from a nurse on 11 Nov 2013: The event was recoded to wrong vaccine administered. FLUZONE was captured as suspect. Dose and site of administration of FLUVIRIN updated.
Age: 2.0
Sex: F
Vaccine: FLU3
Symptoms: Drug administered at inappropriate site, Overdose
Clinical narrative: Case number PHEH2013US021614 is an initial spontaneous report from nurse received on 16 Oct 2013, with a follow-up received on 13 Nov 2013. This case refers to 02-year-old female patient. She received FLUVIRIN (batch number: 1307801), 2.55 cc intramuscularly instead of 0.5 ml, into thigh on 14 Oct 2013 at 6:30 pm. No adverse reaction was reported following medication errors. She was revaccinated with flu vaccine (manufacturer and batch number unknown) on an unspecified date. Follow-up was received on 13 Nov 2013. Patient demographics, vaccination date, vaccination site and time and revaccination information were updated.
Age: 84.0
Sex: F
Vaccine: FLU3
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: Case number PHEH2013US021634 is an initial spontaneous report received from a health care professional on 15 Oct 2013, with a follow-up received on 13 Nov 2013. This report refers to an 84-year-old female patient. She was vaccinated with FLUVIRIN (batch number: 1309001, expiry date: Apr 2014) intramuscularly at a dose of 0.5 ml on 07 Oct 2013. It was reported that the patient received FLUVIRIN that had been stored at a room temperature for up to 24 hours. It was reported that the patient had no adverse reaction following this medication error. Follow-up was received on 13 Nov 2013: Information that the patient had not experienced any reaction was updated.
Age: 31.0
Sex: F
Vaccine: FLU3
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: Case number PHEH2013US020542 is an initial spontaneous report received from a nurse on 30 SEP 2013 with the follow-up received on 14 JAN 2014. This report refers to a 31-year-old female patient. On 27 SEP 2013, she was vaccinated intramuscularly into deltoid with FLUVIRIN 2013/2014 (batch number: 1308401, expiry date: MAR 2014). It was reported that before vaccination, FLUVIRIN was placed in the shipping container at room temperature for 72 hours and later administered to the patient (incorrect storage of vaccine). No adverse event was reported following this medication error.  Follow-up received from nurse on 14 JAN 2014. Site of vaccine administration was updated.
Age: 22.0
Sex: F
Vaccine: FLU3
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: Case number PHEH2013US020546 is an initial spontaneous report received from a nurse on 30 Sep 2013, with the follow-up received on 28 Feb 2014. This report refes to a 22-years-old female patient. On 27 Sep 2013, she was vaccinated with FLUVIRIN (batch number: 1308401, expiry date: Mar 2014) intramuscularly in the deltoid. It was reported that before vaccination, FLUVIRIN was kept in the shipping container at room temperature for 72 hours. No adverse event was reporting following this medication error. Follow-up received from nurse on 28 Feb 2014: Updated vaccination site.
Age: 35.0
Sex: M
Vaccine: FLU3
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: Case number PHHY2013US020534 is an initial spontaneous report received from a nurse on 30 Sep 2013 with a follow-up received on 25 Feb 2014. This report refers to a 35-year-old female patient. Her medical history and concomitant medications were not reported. She was vaccinated with 0.5 ml intramuscular dose of FLUVIRIN (batch number: 1308401, expiry date: Mar 2014) into her deltoid which was placed in room temperature on 27 Sep 2013. It was reported that the nurse was not there when the shipment arrived and it was placed on desk and hence the vaccine in shipping container was placed in room temperature for 72 hours. No adverse event was reported following the medication error. Follow-up received from a nurse on 25 Feb 2014: Site of vaccination and patient's demographics updated. Date of vaccination amended.
Age: 39.0
Sex: F
Vaccine: FLU3
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: Case number PHEH2013YS020535 is an initial spontaneous report received from a nurse on 30 SEP 2013 with a follow-up received on 25 FEB 2014. This report refers to a 39-year-old female patient. On 27 SEP 2013, she was vaccinated with 0.5 ml intramuscular dose of FLUVIRIN 2013/2014 (batch number: 1308401, expiry date: MAR 2014) into her deltoid at 10:00 AM. It was reported that before vaccination. FLUVIRIN ws placed in the shipping container at room temperature for 72 hours and later administered to the patient. No adverse event was reported following this medication error (incorrect storage of vaccine).   Follow-up received from a nurse on 25 FEB 2014: Site and time of vaccination updated.
Age: 61.0
Sex: F
Vaccine: FLU3
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: Case number PHHY2013US020537 is an initial spontaneous report from the nurse received on 30 Sep 2013 with a follow-up received on 25 Feb 2014. This report refers to a 61-year-old female patient. She was vaccinated with FLUVIRIN (batch number: 1308401, expiry date: Mar 2014) at a dose of 0.5 ml at a dose of 0.5 ml via intramuscular route into her deltoid on 27 Sep 2013. It was reported that the vaccine which was given to the patient was stored at temperature during shipment for 72 hours. No adverse event reported following this medication error. Follow-up received from a nurse on 25 Feb 2014: Site of vaccination updated.
Sex: F
Vaccine: FLUX
Symptoms: Malaise
Clinical narrative: On an unspecified  date after the administration of vaccine, the patient became very "ill/sick". The outcome was reported as recovered.
Age: 54.0
Sex: F
Vaccine: FLU3
Symptoms: Burning sensation, Dry skin, Pain, Peripheral coldness, Scar
Clinical narrative: This spontaneous consumer report (initial receipt 21-AUG-2014) concerns a 54-year-old female patient. The patient had a medical history of asthma, high blood pressure and diabetes. The patient received flu vaccines every year and tolerated it in the past.  On 08 JAN 2013, five minutes after vaccination, the patient's hands began to feel icy cold as if the fingers would fall off. She wore gloves and returned to the clinic, 10 minutes later. Her vitals were evaluated, which were normal. After leaving the clinic, she noticed that her hands , arms, stomach and chest were painful and would burn. She had burned marks on these areas that resembled chemotherapy burns from cancer treatment.  The patient confirmed that she never had cancer. These burned areas of the skin occasionally will tighten-up causing additional pain. There were some marks on her face as well. These burned areas of her skin had not changed since she received AFLURIA. She was sent to a dermatologist for evaluation. She received a cream to use only when the tightening sensation occurred on the skin. The burned areas were dry and she had to use a Vaseline to assist with dryness.  The outcome was reported as recovered with sequelae for the event of icy cold hands, however, the other events had not recovered.
Age: 54.0
Sex: F
Vaccine: FLU3
Symptoms: Skin tightness
Clinical narrative: This spontaneous consumer report (initial receipt 21-AUG-2014) concerns a 54-year-old female patient. The patient had a medical history of asthma, high blood pressure and diabetes. The patient received flu vaccines every year and tolerated it in the past.  On 08 JAN 2013, five minutes after vaccination, the patient's hands began to feel icy cold as if the fingers would fall off. She wore gloves and returned to the clinic, 10 minutes later. Her vitals were evaluated, which were normal. After leaving the clinic, she noticed that her hands , arms, stomach and chest were painful and would burn. She had burned marks on these areas that resembled chemotherapy burns from cancer treatment.  The patient confirmed that she never had cancer. These burned areas of the skin occasionally will tighten-up causing additional pain. There were some marks on her face as well. These burned areas of her skin had not changed since she received AFLURIA. She was sent to a dermatologist for evaluation. She received a cream to use only when the tightening sensation occurred on the skin. The burned areas were dry and she had to use a Vaseline to assist with dryness.  The outcome was reported as recovered with sequelae for the event of icy cold hands, however, the other events had not recovered.
Sex: F
Vaccine: FLUX
Symptoms: Vaccination complication
Clinical narrative: This medically confirmed non-serious report (initial report 21-AUG-2014) concerns a female patient. The patient had a medical history of shingles in the past. On an unspecified date, the patient received ZOSTAVAX and subsequently was diagnosed with recurrence of shingles. On an unspecified date, the patient received influenza vaccine (manufacturer and batch number not reported). On an unspecified date, after receiving the influenza vaccination, the patient developed an unspecified reaction. Outcome was reported as recovered.  Reporter's comments: The reporter could not confirm if it was AFLURIA as the reporter did not administer influenza vaccine to the patient.
Age: 21.0
Sex: F
Vaccine: FLU3
Symptoms: Facial neuralgia, Hypoaesthesia, Neuralgia, Paraesthesia
Clinical narrative: This medically confirmed non-serious report (initial receipt 17-AUG-2014) concerns a 21-year old female patient. On 16 AUG-2014, The patient received AFLURIA injection (batch number T57205).  On 16-APR-2014, after vaccination, the patient experienced neuralgia. The patient was still experiencing neuralgia on the left side of the face. She also developed left arm tingling and some numbness of her  neck. The outcome was reported as not yet recovered.
Sex: F
Vaccine: FLUX, PPV
Symptoms: Injection site erythema, Injection site pain, Injection site plaque, Injection site swelling, Oedema peripheral
Clinical narrative: This non-serious medically spontaneous report (initial receipt 12-AUG 2014) concerns a female patient who had tenderness and swelling in her armpit on the evening of 04-AUG-2014 following the administration of a pneumonia vaccine which she thought it was PNEUMOVAX (0.5 ml, batch number J009827). She also had plagues, which looked like hive, that were "about 2-3 inches in diameter around the injection site the next day". She also had one plaque that developed the "next day" on her inner arm that was slightly elevated and very red and tender. The plaque on her inner arm had "gone down today". Following the administration of an unspecified tetanus vaccine on an unspecified date, she had an unspecified arm swelled "2 to 3 times it's previous size".  On an unspecified date, the patient received influenza vaccine (manufacturer and batch number not provided). On an unspecified date following the influenza vaccine, the patient developed a "hill" at the injection site. Medical attention was not sought.  Outcome was reported as recovering.   Reporter's comments: The reporter commented that an unspecified pneumonia vaccine was the "harder" of the vaccines to administer to children due to adverse reactions that can develop.  The reporter did not provide any further information about children.