chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Sex: U
Vaccine: FLU3
Symptoms: Chills, Dizziness, Pain
Clinical narrative: Case number PHEH2014US020801, is an initial spontaneous report from a health care professional received on 13 Oct 2014. This report refers to patient of unknown demographics. Historical conditions were not reported. No concomitant medication was reported. The patient was vaccinated with FLUVIRIN (batch number: 1411501) intramuscularly at a dose of 0.5 ml on an unknown date. On an unknown date after vaccination, the patient experienced chills, dizzy and body aches lasting for 24 hours. The final outcome of the events was unknown. Seriousness and causality was not reported.
Age: 38.0
Sex: F
Vaccine: FLU3
Symptoms: Chills, Flushing, Headache, Malaise, Nausea
Clinical narrative: Case number PHEH2014US020259 is an initial spontaneous report from the nurse received on 08 Oct 2014. This report refers to a 38-year-old female patient. She was vaccinated with FLUVIRIN (batch number: 1411601) intramuscularly on 08 Oct 2014 (at 09:00 am). On the same date, after vaccination she experienced general malaise, nausea, headache, chills and flushed cheeks. The outcome of the events was unknown. The seriousness and causality of the events were not reported.
Sex: F
Vaccine: FLU3
Symptoms: Exposure during pregnancy, No adverse event
Clinical narrative: Case number PHEH2012US020266 is an initial spontaneous report received from a pharmacist on 05 Oct 2012. This report refers to a female patient whose age was not reported. She was vaccinated with FLUVIRIN (batch number: not reported) on an unknown date (vaccination date was reported as a month ago). It was reported that she was not pregnant at the time of administration of FLUVIRIN from a multi dose vial, but she got pregnant after receiving vaccine. No adverse reactions were reported. 11 Jun 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.
Sex: U
Vaccine: FLU3
Symptoms: Injected limb mobility decreased, Pain
Clinical narrative: Case number PHHY2014US068091 is an initial spontaneous report received from a pharmacist on 27 May 2014. This report refers to patient whose identifiers were not reported. Past medical history and concomitant medication were not reported. The patient was vaccinated with an initial dose of FLUVIRIN (batch number: not reported) intramuscularly on an unknown date. It was reported that on an unknown date after vaccination, the patient experienced painful and limited movement of arm. Arm affected was the arm the patient received the injection in. The outcome, seriousness and causality of the events were not reported.
Age: 67.0
Sex: F
Vaccine: FLU3
Symptoms: Injection site erythema
Clinical narrative: Case number PHHY2014US072161, is an initial spontaneous report from a pharmacist via Vaccine adverse event reporting website (VAERS id: 525919) received on 09 Jun 2014. This report refers to a 67 year old (at the time of reporting) female patient. Medical history included allergy to vaccine and herpes zoster. Concomitant therapies included warfarin sodium, atorvastatin and methocarbamol. On an unknown date of Oct 2013, she was vaccinated with FLUVIRN (batch number: unknown). On 14 Oct 2013, she experienced redness around injection site. On 06 Mar 2014, the patient was vaccinated with ZOSTAVAX (batch number: unknown). On an unknown in Mar 2014, the patient developed similar reactions like after vaccination with FLUVIRIN. Patient contacted pharmacist for medical attention. Patient took BENADRYL. The outcome of the event was unknown. Seriousness and causality of the event was not reported. No further information provided.
Sex: F
Vaccine: FLU3
Symptoms: Pain in extremity
Clinical narrative: Case number PHHY2014US092088 is an initial spontaneous report received from vaccine adverse event reporting system (VAERS reference number: 517845) website on 24 Jul 2014. Past medical history and concomitant medication were not provided. This report refers to an adult female patient. She was vaccinated with FLUVIRIN (batch number: unknown) in 1993. Post vaccination she experienced sore arm. Seriousness, outcome and causality of the event were not reported.
Sex: F
Vaccine: FLU3
Symptoms: Pain in extremity
Clinical narrative: Case number PHHY2014US092090 is an initial spontaneous report received from vaccine adverse event reporting system (VAERS reference number: 517845) website on 24 Jul 2014. This report refers to an adult female patient. Her medical history included sore arm in 1993 and 1994 post vaccination with FLUVIRIN (see cases: PHHY2014US092088 and PHHY2014US092089 respectively). She was vaccinated with FLUVIRIN (batch number: unknown) in 1995. Post vaccination she experienced sore arm. Seriousness, outcome and causality of the event were not reported.
Age: 51.0
Sex: F
Vaccine: FLU3
Symptoms: Injection site erythema, Injection site induration, Injection site mass
Clinical narrative: Case number PHEH2014US008841 is an initial spontaneous report from the pharmacist received on 30 Apr 2014. This report refers to a 51-year-old female patient. She was vaccinated with FLUVIRIN (batch number: not reported) on an unknown date in Nov 2013. On an unknown date, after vaccination she experienced red, hard lump at the injection site. The injection site was non-tender. The outcome of the event reported as not recovered at the time of the report. The seriousness and causality of the event were not reported.
Sex: U
Vaccine: FLU3
Symptoms: Contraindication to vaccination
Clinical narrative: Case number PHEH2014US020158, is an initial spontaneous report from a pharmacist received on 06 Oct 2014. This report refers to a patient of unknown demographics. Concurrent conditions included latex allergy. No concomitant medication was reported. The patient was vaccinated with FLUVIRIN (batch number: not provided) intramuscularly on 06 Oct 2014 without any reports of patient harm. It was reported that severity of the latex allergy of the patient was unknown. No adverse event reported.
Sex: F
Vaccine: FLU3
Symptoms: Erythema, Peripheral swelling, Skin warm
Clinical narrative: Case number PHEH2014US020232 is an initial spontaneous report from the health care professional (patient) received on 01 Oct 2014. This report refers to an adult female patient. She was vaccinated with FLUVIRIN (batch number: not reported) on an unknown date. On an unknown date, after vaccination her arm was swollen, red and hot. The outcome of the events was not reported. The patient received FLUVIRIN for the next 7 years and experienced similar events (see cases: PHEH2014US020234, PHEH2014US020235, PHEH2014US020236, PHEH2014US020237, PHEH2014US020238, PHEH2014US020239 and PHEH2014US020240).
Sex: F
Vaccine: FLU3
Symptoms: Erythema, Peripheral swelling, Skin warm
Clinical narrative: Case number PHEH2014US020234 is an initial spontaneous report from the health care professional (patient) received on 01 Oct 2014. This report refers to an adult female patient. She was vaccinated with FLUVIRIN (batch number: not reported) in the previous year and her arm was swollen, red and hot (see case: PHEH2014US020232). She was again vaccinated with FLUVIRIN (batch number: not reported) on an unknown date. On an unknown date, after vaccination her arm was swollen, red and hot. The outcome of the event was not reported. The patient received FLUVIRIN for the next 6 years and experienced similar events (see cases: PHEH2014US020235, PHEH2014US020236, PHEH2014US020237, PHEH2014US020238, PHEH2014US020239 and PHEH2014US020240).
Sex: F
Vaccine: FLU3
Symptoms: Erythema, Peripheral swelling, Skin warm
Clinical narrative: Case number PHEH2014US020236 is an initial spontaneous report from a health care professional (patient) received on 01 Oct 2014. This report refers to an adult female patient. Her medical history and concomitant medications were not reported. Her vaccination history included administration of three doses of FLUVIRIN (batch numbers: not reported) in the previous years following which her arm was swollen, red and hot (see related case numbers: PHEH2014US020232, PHEH2014US020234 and PHEH2014US020235). She was vaccinated with FLUVIRIN (batch number: not reported) on an unknown date. On an unknown date, after vaccination her arm was swollen, red and hot .The outcome of the events was not reported. The patient received FLUVIRIN for the next 4 years and experienced similar events (see related case numbers: PHEH2014US020237, PHEH2014US020238, PHEH2014US020239 and PHEH2014US020240).
Sex: F
Vaccine: FLU3
Symptoms: Erythema, Peripheral swelling, Skin warm
Clinical narrative: Case number PHEH2014US02020237 is an initial spontaneous report received from a health care professional (also patient) on 01 Oct 2014. This report refers to an adult female patient of unknown age. Her medical history and concomitant medications were not reported. Her vaccination history included administration of other vaccines such as tetanus booster (unknown manufacturer, batch number: not reported) on unknown date and was well tolerated. She also received FLUVIRIN (batch number: not reported) intramuscularly in the past (unknown number of doses) and experienced events (see related case numbers: PHEH2014US020232, PHEH2014US020234, PHEH2014US020235, PHEH2014US020236).  She was vaccinated with FLUVIRIN (batch number: not reported) intramuscularly on unspecified date. It was reported that on an unknown date after vaccination, her arm was swollen, red and hot. The outcome, seriousness and causality of the event were not reported. She was also vaccinated with FLUVIRIN (batch number: not reported) on unspecified date in next 3 years and experienced similar events (see related case number: PHEH2014US020238, PHEH2014US020239, PHEH2014US020240).
Sex: F
Vaccine: FLU3
Symptoms: Erythema, Peripheral swelling, Skin warm
Clinical narrative: Case number PHEH2014US02020238 is an initial spontaneous report received from a health care professional (also patient) on 01 Oct 2014. This report refers to an adult female patient of unknown age. Her medical history and concomitant medications were not reported. Her vaccination history included administration of other vaccines such as tetanus booster (unknown manufacturer, batch number: not reported) on unknown date and was well tolerated. She also received FLUVIRIN (batch number: not reported) intramuscularly in the past (unknown number of doses) and experienced events (see related case numbers: PHEH2014US020232, PHEH2014US020234, PHEH2014US020235, PHEH2014US020236, PHEH2014US020237). She was vaccinated with FLUVIRIN (batch number: not reported) intramuscularly on unspecified date. It was reported that on an unknown date after vaccination, her arm was swollen, red and hot. The outcome, seriousness and causality of the event were not reported. She was also vaccinated with FLUVIRIN (batch number: not reported) on unspecified date in next 2 years and experienced similar events (see related case number: PHEH2014US020239, PHEH2014US020240).
Sex: F
Vaccine: FLU3
Symptoms: Erythema, Peripheral swelling, Skin warm
Clinical narrative: Case number PHEH2014US02020239 is an initial spontaneous report received from a health care professional (also patient) on 01 Oct 2014. This report refers to an adult female patient of unknown age. Her medical history and concomitant medications were not reported. Her vaccination history included administration of other vaccines such as tetanus booster (unknown manufacturer, batch number: not reported) on unknown date and was well tolerated. She also received FLUVIRIN (batch number: not reported) intramuscularly in the past (unknown number of doses) and experienced events (see related case numbers: PHEH2014US020232, PHEH2014US020234, PHEH2014US020235, PHEH2014US020236, PHEH2014US020237, PHEH2014US020238). She was vaccinated with FLUVIRIN (batch number: not reported) intramuscularly on unspecified date. It was reported that on an unknown date after vaccination, her arm was swollen, red and hot. The outcome, seriousness and causality of the event were not reported. She was also vaccinated with FLUVIRIN (batch number: not reported) on unspecified date in next year and experienced similar events (see related case number: PHEH2014US020240).
Sex: U
Vaccine: FLU3
Symptoms: Dizziness
Clinical narrative: Case number PHEH2014US020799 is an initial spontaneous report received from a health care professional on 13 Oct 2014. This report refers to a patient of unknown identifiers. The patient's medical history and concomitant medications were not reported. The patient was vaccinated with FLUVIRIN (batch number: 1411501) intramuscularly at a dose of 0.5 ml on unspecified date. It was reported that the patient felt light headed. The outcome of the event was reported as unknown. The seriousness and causality of the event were not reported. No additional details available.
Age: 40.0
Sex: F
Vaccine: FLU3
Symptoms: Swelling
Clinical narrative: Case number PHEH2014US020662 is an initial spontaneous report from the nurse received on 10 Oct 2014. This report refers to a 40-year-old female patient. She was vaccinated with FLUVIRIN (batch number: 1410801) intramuscularly on 10 Oct 2014. On the same date, 30 minutes after vaccination her had started swelling. The outcome of the event was unknown. The seriousness and causality of the event were not reported.
Age: 27.0
Sex: M
Vaccine: FLU3
Symptoms: Dizziness, Hot flush
Clinical narrative: Case number PHEH2014US020531 is an initial spontaneous report received from the pharmacist on 01 Oct 2014. This report refers to a 27 years old male patient. His medical history and concomitant medications were not reported. He was vaccinated with FLUVIRIN (batch number: 1411101, expiry date: Apr 2015) on 01 Oct 2014. It was reported that after vaccination he experienced hot flashes, dizziness and light headed. The outcome, seriousness and causality of the events were not reported.
Age: 45.0
Sex: F
Vaccine: FLU3
Symptoms: Erythema, Peripheral swelling, Skin warm
Clinical narrative: Case number PHEH2014US020240, is an initial spontaneous report from a health care professional (also patient) received on 01 Oct 2014. This report refers to an approximately 45-year-old female patient. Historical conditions were not reported. No concomitant medication was reported. Vaccination history included administration of FLUVIRIN and tetanus. She was vaccinated with FLUVIRIN (batch number: not reported) intramuscularly on an unknown date in the last year (2013). On an unknown date after vaccination in the last year (2013), her arm was swollen, red and hot. It was the same reaction every year and get increasingly worse every year. This ws probably happening for eight years (see case: PHEH2014US020232, PHEH2014US020234, PHEH2014US020235, PHEH2014US020236, PHEH2014US020237, PHEH2014US020238 and PHEH2014US020239). It was reported that the reaction does not happen immediately but builds up. However, last year was the worst as it spread and was probably four or five inches. She states that she had other vaccines that did not bother her for example tetanus booster. She reported that the last year reaction as pretty bad reaction and was told she would not be vaccinated with FLUVIRIN. The final outcome of the events was unknown. Seriousness and causality was not reported.
Age: 54.0
Sex: F
Vaccine: FLU3
Symptoms: Injection site erythema, Injection site swelling
Clinical narrative: Case number PHEH2013US023738 is an initial spontaneous report received from a consumer on 11 Nov 2013. This report refers to a 54-year-old female patient. Her medical history included latex allergy. Her concomitant medications were not reported. She had well tolerated the vaccines which she administered in the past. She was vaccinated with FLUVIRIN (batch number: unknown) intramuscularly in her left arm from a MDV on 09 Nov 2013 at 6:30 pm. She experienced localized redness (one inch in diameter) and swelling at the injection site at an unknown date, after vaccination. She had completely recovered from the events after two days. The seriousness and causality of the events were not assessed. Significant follow up received from the consumer on 17 Dec 2013: Vaccination date and time, vaccination site and event duration were updated.
Sex: F
Vaccine: FLU3
Symptoms: Erythema, Pain in extremity, Skin warm
Clinical narrative: Case number PHEH2013US023953 is an initial spontaneous report received from a consumer on 14 Nov 2013: This report refers to a female patient of unknown age. She was vaccinated with FLUVIRIN (batch number: unknown) on an undetermined date. Within 12 hours of receiving the vaccine, on 17 Sep 2013, her arm was 'real sore' and by evening it was red and hot. She was not able to lie on her arm at night. Next morning the reaction had spread all the way around and down to the elbow. Her arm was 'super red', very painful and feverish. She was given a steroid shot and two different unspecified antibiotics. The reaction subsided on 25 Sep 2013. No additional information about seriousness and causality was mentioned.
Sex: F
Vaccine: FLU3
Symptoms: Hypersensitivity, Pruritus, Urticaria
Clinical narrative: Case number PHEH2013US024088 is an initial spontaneous report received from a pharmacist on 17 Nov 2013. This report refers to a female patient of unknown age. She was vaccinated with FLUVIRIN (batch number: unknown) into left arm on 14 Nov 2013. She developed an allergic reaction where her skin on arms and neck became itchy and broke out in hives. Outcome, seriousness and causality of the event were not reported.
Sex: F
Vaccine: FLU3
Symptoms: Hypersensitivity
Clinical narrative: Case number PHEH2013US024741 is an initial spontaneous report received from a consumer 25 Nov 2013. This case refers to a female patient of unknown age. She was vaccinated with FLUVIRIN (batch number: 1308601, expiration date: Mar 2014) on an unspecified date. The patient had an allergic reaction to FLUVIRIN after vaccination (date unspecified). The seriousness, outcome and causality were not reported.
Age: 50.0
Sex: F
Vaccine: FLU3
Symptoms: Mobility decreased, Pain in extremity
Clinical narrative: Case number PHEH2013US026195 is an initial spontaneous report received from a pharmacist on 20 Dec 2013. This report refers to a 50-year-old female patient. On 22 Nov 2013, she was vaccinated with FLUVIRIN (batch number: not reported) in the arm. She reported that since vaccination, her arm had been sore and she could make limited ise of her arm. The outcome, seriousness and causality of the events were not reported.
Age: 10.0
Sex: F
Vaccine: FLU3
Symptoms: Lymphadenopathy
Clinical narrative: Case number PHEH2014US020312, is an initial spontaneous report from a nurse received on 07 Oct 2014. This report refers to a 10-year-old female patient. Historical conditions were not reported. No concomitant medication was reported. She was vaccinated with FLUVIRIN (batch number: 1412901) intramuscularly into the left arm on an unknown date. On 29 Sep 2014, she developed two swollen nodes above her collarbone on left side (reaction). On 03 Oct 2014, she completely recovered from the event. Seriousness and causality was not reported.
Age: 60.0
Sex: M
Vaccine: PPV
Symptoms: Chills, Decreased appetite, Flatulence, Haematochezia, Injection site erythema
Clinical narrative: This spontaneous report as received from a consumer reporting on himself. The patient was a 60 year old male with a SEPTRA sensitivity Meniere's disease. The patient also had a history of unspecified adverse events to unspecified vaccines (manufacturer unknown). On 03DEC2014 the patient was vaccinated with PNEUMOVAX23. Concomitant therapies included CLARITIN. On 04DEC2014 the patient woke up and vomited "about a cup of bile". After waking up to vomit, he noticed redness and pain at the injection site and also experiencing chills, aches and pains through out his entire body. because the aching worsened, the patient was only able to sleep about an hour that night after waking up to vomit. He reported that the aching and chills persisted through the following day on 05DEC2014. On 05DEC2014 the patient was flatulent and wound up inadvertently passing three to four table spoons of blood and stool into his undergarments. He noted the stool was rose colored with pink mucosal blood droplets. He reported that his stool became less pink over the weekend and on 08DEC2014 it was back to normal. The patient also complained of a decreased appetite since he received PNEUMOVAX23. The patient took one TYLENOL every six hours to treat the body aches. he reported that he recovered from all of his adverse effects except for redness at the injection site. The patient had blood testing done on 05DEC2014 that showed an increased white blood cell count. The patient reported the expiration date for the PNEUMOVAX as March 2016 because the clinic provided him only with the month and year. The clinic did not provided the lot number. The patient reported seeking medical attention and visited his physician (NOS). Additional information has been requested.
Age: 60.0
Sex: M
Vaccine: PPV
Symptoms: Injection site pain, Insomnia, Pain, Vomiting, White blood cell count increased
Clinical narrative: This spontaneous report as received from a consumer reporting on himself. The patient was a 60 year old male with a SEPTRA sensitivity Meniere's disease. The patient also had a history of unspecified adverse events to unspecified vaccines (manufacturer unknown). On 03DEC2014 the patient was vaccinated with PNEUMOVAX23. Concomitant therapies included CLARITIN. On 04DEC2014 the patient woke up and vomited "about a cup of bile". After waking up to vomit, he noticed redness and pain at the injection site and also experiencing chills, aches and pains through out his entire body. because the aching worsened, the patient was only able to sleep about an hour that night after waking up to vomit. He reported that the aching and chills persisted through the following day on 05DEC2014. On 05DEC2014 the patient was flatulent and wound up inadvertently passing three to four table spoons of blood and stool into his undergarments. He noted the stool was rose colored with pink mucosal blood droplets. He reported that his stool became less pink over the weekend and on 08DEC2014 it was back to normal. The patient also complained of a decreased appetite since he received PNEUMOVAX23. The patient took one TYLENOL every six hours to treat the body aches. he reported that he recovered from all of his adverse effects except for redness at the injection site. The patient had blood testing done on 05DEC2014 that showed an increased white blood cell count. The patient reported the expiration date for the PNEUMOVAX as March 2016 because the clinic provided him only with the month and year. The clinic did not provided the lot number. The patient reported seeking medical attention and visited his physician (NOS). Additional information has been requested.
Age: 76.0
Sex: M
Vaccine: PNC
Symptoms: Asthenia, Blood pressure decreased, Hypotension, Injection site pain, Nausea
Clinical narrative: Patient with pain on injection site, feeling weak, BP down 104/62, received DEPO-MEDROL injection. Nausea, vomiting, hypotension and pain.
Age: 76.0
Sex: M
Vaccine: PNC
Symptoms: Pain, Vomiting
Clinical narrative: Patient with pain on injection site, feeling weak, BP down 104/62, received DEPO-MEDROL injection. Nausea, vomiting, hypotension and pain.
Age: 0.27
Sex: M
Vaccine: DTAPHEPBIP
Symptoms: Inappropriate schedule of drug administration
Clinical narrative: This case was reported by a nurse and described the occurrence of inappropriate schedule of vaccine administered in a 14-week-old male patient who received PEDIARIX (batch number 524HS, expiry date 29th August 2016). On 24th September 2014, the patient received PEDIARIX. On 24th September 2041, an unknown time after receiving PEDIARIX, the patient experienced inappropriate schedule of vaccine administered. On an unkonwn date, the outcome of the inappropriate schedule of vaccine administered was unknown. Additional information: HCP gave a 1st dose of PEDIARIX a little late from the recommended 2 month age. The patient was 3 month and 6 days old when received the 1st dose.
Age: 72.0
Sex: M
Vaccine: PPV
Symptoms: Injection site erythema, Injection site irritation
Clinical narrative: Patient developed redness and irritation at the site of PNEUMOVAX injection. Patient went to emergency department for evaluation and received CALADRYL, hydrocortisone cream and prednisone. Rash.
Sex: U
Vaccine: PPV
Symptoms: Inappropriate schedule of drug administration, No adverse event
Clinical narrative: Information has been received on 08DEC2014 from a physician regarding a patient (gender not reported). The physician reported the patient received two doses of PNEUMOVAX 23 on unspecified dates, before age 65 years. This statement was unable to be further clarified. Physician additionally stated he knew of other unspecified physicians who routinely vaccinated their unspecified patients over 65 years with PNEUMOVAX 23 (every 5 years, regardless of their situation (see MARRS # 1412USA004604). No adverse effect reported. No additional information provided. Physician needed to disconnect call before AE collection was initiated, therefore all fields are NA. Additional information has been requested.
Age: 0.8
Sex: U
Vaccine: HEP
Symptoms: Extra dose administered
Clinical narrative: This case was reported by a nurse and described the occurrence of extra dose administered in a 8-month-old patient who received ENGERIX B. Previously administered products included hepatitis b vaccine (dose 1), hepatitis b vaccine (dose 2) and hepatitis b vaccine (dose 3). On an unknown date, the patient received the 4th dose of ENGERIX B. On an unknown date, an unknown time after receiving ENGERIX B, the patient experienced extra dose administered. On an unknown date, the outcome of the extra dose administered was unknown. Additional information received: 8 month old received 4 doses of Hep B, the 4th dose was ENGERIX B.
Age: 28.0
Sex: F
Vaccine: PPV
Symptoms: Exposure during pregnancy, Exposure via direct contact, Eye irrigation, Eye irritation, Occupational exposure to product
Clinical narrative: This spontaneous report has been received from a nurse who states that on 17-DEC-2014, a 28-year-old female office worker "was administering PNEUMOVAX 23, needle was in a (male) patient's arm, but syringe loosened, and the staff member had PNEUMOVAX 23 splash on her face and in both her eyes." The nurse stated that the office worker "washed her face and flushed her eyes with water. This occurred today; some irritation of the eyes." It is unknown if the male got any of the dose. The male patient was given another dose of PNEUMOVAX 23 after the occurrence; unspecified what site. The nurse called back, on the same day, 17-DEC-2014, and reported that "the office worker who had PNEUMOVAX 23 inadvertently splashed in her eye (as reported) is pregnant. Gestation time is unknown." No further information was provided. Additional information will be requested.
Sex: U
Vaccine: TDAP
Symptoms: Diarrhoea, Injection site pain, Neck pain, Pain
Clinical narrative: This case was reported by a other health professional and described the occurrence of injection site tenderness in a patient who received BOOSTRIX (batch number L7J44, expiry date 31st May 2016). On an unknown date, the patient received BOOSTRIX. On an unknown date, an unknown time after receiving BOOSTRIX, the patient experienced injection site tenderness, irradiating pain and diarrhea. On an unknown date, the outcome of the injection site tenderness, irradiating pain and diarrhea were unknown. It was unknown if the reporter considered the injection site tenderness, irradiating pain and diarrhea to be related to BOOSTRIX. Additional information received: Patient who received BST yesterday now has tenderness in the left arm (the arm that she received the BST injection), and pain, and the pain is radiating up the neck, also the patient has diarrhea.
Age: 1.54
Sex: M
Vaccine: MMR
Symptoms: Erythema
Clinical narrative: Information has been received from a Registered Nurse concerning an 18 month old male patient with multiple food allergies including egg, wheat, corn and peanuts. On 08DEC2014 the patient was vaccinated with M-M-R II, .5 ml, subcutaneous. On 08DEC2014, the patient experienced redness of his facial cheeks after administration of M-M-R II. The outcome of redness of his facial cheeks was reported as not recovered/not resolved. Additional information is expected.
Sex: U
Vaccine: DTAP, TDAP
Symptoms: Extra dose administered, No adverse event
Clinical narrative: This case was reported by a pharmacist and described the occurrence of extra dose administered in a patient who received INFANRIX. Co-suspect products included BOOSTRIX. Concomitant products included INFANRIX. On an unknown date, the patient received INFANRIX at an unknown dose and BOOSTRIX at an unknown dose. On an unknown date, an unknown time after receiving INFANRIX and BOOSTRIX, the patient experienced extra dose administered. On an unknown date, the outcome of the extra dose administered was unknown. Additional information: The pharmacist did not have any patient information. The patient has not experienced any adverse event yet. But an adult patient got a dose of INFANRIX from the clinic and later on the same day got a dose of BOOSTRIX or INFANRIX from the primary provider.
Age: 11.0
Sex: M
Vaccine: DTAP
Symptoms: Drug administered to patient of inappropriate age, No adverse event, Wrong drug administered
Clinical narrative: This case was reported by a nurse and described the occurrence of wrong vaccine administered in 11-year-old male patient who received INFANRIX (batch number 75H53, expiry date 27th July 2016). On 3rd November 2014, the patient received INFANRIX. On an unknown date, an unknown time after receiving INFANRIX, the patient experienced wrong vaccine administered and inappropriate age at vaccine administration. On an unkonwn date, the outcome of the wrong vaccine administered and inappropriate age at vaccine administration were unknown. Additional information received: On 03 November 2014, an 11 years old patient was given a dose of INFANRIX as their Tdap booster dose. As of now, the patient has not reported any adverse event. HCP did not know why this error occurred.
Age: 28.0
Sex: U
Vaccine: HEP
Symptoms: Drug administered to patient of inappropriate age, No adverse event, Underdose
Clinical narrative: This case was reported by a other health professional and described the occurrence of vaccine underdose in a 28-year-old patient who received ENGERIX B pediatric (batch number BT24B, expiry date unknown). On 31st October 2014, the patient received ENGERIX B pediatric .5 ml. On an unknown date, an unknown time after receiving ENGERIX B pediatric, the patient experienced vaccine underdose and inappropriate age at vaccine administration. On an unknown date, the outcome of the vaccine underdose and inappropriate age at vaccine administration were unknown. Additional information received: Pediatric dose given to an adult. No adverse event reported.
Age: 31.0
Sex: F
Vaccine: HEP
Symptoms: Incorrect dose administered, Underdose
Clinical narrative: This case was reported by a nurse and described the occurrence of vaccine underdose in a 31-year-old female patient who received ENGERIX B. On 3rd November 2014, the patient received the 1st dose of ENGERIX B 10 micrograms. On 3rd November 2014, an unknown time after receiving ENGERIX B, the patient experienced vaccine underdose. On an unknown date, the outcome of the vaccine underdose was unknown. Additional information: 31-year-old female was given 10 mcg of ENGERIX-B inadvertently by a new staff nurse, instead of 20 mcg adult dose.
Age: 11.0
Sex: M
Vaccine: HPV2
Symptoms: Off label use, Wrong drug administered
Clinical narrative: This case was reported by a pharmacist and described the occurrence of wrong vaccine administered in a 11-year-old male patient who received CERVARIX. Previously administered products included GARDASIL. In September 2014, the patient received CERVARIX. On an unknown date, an unknown time after receiving CERVARIX, the patient experienced wrong vaccine administered and off label use. On an unknown date, the outcome of the wrong vaccine administered and off label use were unknown. It was unknown if the reporter considered the wrong vaccine administered and off label use to be related to CERVARIX. Additional information received: Father reporting his son was given a GARDASIL vaccination a few months ago, and instead of giving the GARDASIL second dose, his son received CERVARIX. Note: Father mentioned at the end of the call that he was a pharmacist.
Sex: U
Vaccine: FLU3
Symptoms: Extra dose administered
Clinical narrative: This case was reported by a pharmacist and described the occurrence of extra dose administered in a patient who received FLUARIX QUADRIVALENT. On an unknown date, the patient received FLUARIX QUADRIVALENT at an unknown dose. On an unknown dose, an unknown time after receiving FLUARIX QUADRIVALENT, the patient experienced extra dose administered. On an unknown date, the outcome of the extra dose administered was unknown. Additional information: A dose of quadrivalent flu vaccine (likely FLUARIX QIV) was administered to an adult patient one month after administration of the same vaccine to the same patient. No further info available at the time of reporting.
Sex: U
Vaccine: PPV
Symptoms: Inappropriate schedule of drug administration, Injection site swelling, Peripheral swelling
Clinical narrative: This spontaneous report has been received from a physician referring to a patient of unknown age and gender. On an unknown date the patient was vaccinated with one dose of PNEUMOVAX 23 (lot # and dose not reported). On an unknown date (one year after the first dose of PNEUMOVAX 23), the patient received the second dose of PNEUMOVAX 23 (lot # and dose not reported). Then on an unknown date, the patient experienced swelling at injection site and overall swelling in the arm that the second dose of vaccine was administered. The patient was treated with unspecified steroids on unspecified date. At the time of report, the patient had been fully recovered. This is one of several reports received from the same source. Additional information is not expected because the reporter did not want to be contacted.
Age: 20.0
Sex: F
Vaccine: HPV4
Symptoms: Headache
Clinical narrative: Information has been received from a physician on 17-DEC-2014 via a company representative. The physician, who was also the mother of a 20 year old female patient, disclosed that her daughter has been getting headaches after receiving her first dose of GARDASIL (lot number and expiration date not provided) about 30 days ago. These headaches have been persistent for the last 30 days. The outcome was not reported. The causality was not reported. No other information was provided. Additional information is not expected.
Age: 40.0
Sex: F
Vaccine: FLU3
Symptoms: No reaction on previous exposure to drug, Pruritus, Rash generalised
Clinical narrative: This case was reported by a nurse and described the occurrence of generalized rash in a 40-year-old female patient who received FLUARIX (batch number 45HX7, expiry date 30th June 2015). Previously administered products included flu vaccine with an associated reaction of no adverse event. On 5th November 2014, the patient received FLUARIX 1 ml. On 5th November 2014, an unknown time after receiving FLUARIX, the patient experienced generalize rash and pruritus. The patient was treated with BENADRYL. On an unknown date, the outcome of the generalized rash and pruritus were not recovered/not resolved. It was unknown if the reporter considered the generalized rash and pruritis to be related to FLUARIX. Additional information received: Nurse reports a patient received FLUARIX TIV on 11/5. After patient went home, she called the office stating  she now "is covered with itching and rash".
Age: 91.0
Sex: F
Vaccine: VARZOS
Symptoms: Herpes zoster
Clinical narrative: This spontaneous report as received from a consumer as a part of a marketing research program, refers to a 91 year old female patient with dementia. On an unknown date, the patient was vaccinated with ZOSTAVAX (dose, lot number, and expiration date were not reported). On an unkonwn date after vaccination, the patient experienced shingles. The outcome of shingles was reported as recovered/resolved with sequelae. The reporter considered shingles to be related to ZOSTAVAX. Additional information is not expected as there is no consent to contact the patient or a doctor.
Sex: U
Vaccine: HEPA
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report was received from a other health professional (nurse) refers to a patient of unknown age and gender. On 06-JAN-2015 the patient was vaccinated with improperly stored VAQTA (lot # K008252, expiration date: 24-OCT-2015), .5 ml, doses (unspecified in series) intramuscular. No adverse effects were reported. Outcome of the event was not reported. Reporter considered the event to be not related to VAQTA. This is one of several reports received from the same source (MARRS # 1501USA003826, MARRS # 1501USA004957, MARRS # 1501USA004958, MARRS # 1501USA004959 and 1501USA004960). Additional information has been requested.
Sex: M
Vaccine: VARZOS
Symptoms: Extra dose administered
Clinical narrative: Information has been received from a consumer referring to her husband of unknown age. On an unknown date, the patient was vaccinated with ZOSTAVAX (strength, lot number, expiry date, route, dosage were not reported). On an unknown date, the patient was vaccinated with the second dose of ZOSTAVAX (strength, lot number, expiry date, route, dosage were not reported). Additional information is not expected as there was no correspondence information available.
Age: 12.0
Sex: F
Vaccine: DTAP
Symptoms: Drug administered to patient of inappropriate age, Wrong drug administered
Clinical narrative: This case was reported by a other health professional and described the occurrence of wrong vaccine administered in a 12-year-old female patient who received INFANRIX (batch number AC14B169BA, expiry date 20th March 2015). On an unknown date, the patient received INFANRIX. On an unknown date, an unknown time after receiving INFANRIX, the patient experienced wrong vaccine administered and inappropriate age at vaccine administration. On an unknown date, the outcome of the wrong vaccine administered and inappropriate age at vaccine administration were unknown. Additional information received: 12 yo vaccinated with INFANRIX, HCP intended to provide BOOSTRIX. No other information was shared.
Sex: U
Vaccine: PPV
Symptoms: Injection site swelling, Peripheral swelling
Clinical narrative: This spontaneous report as received from a physician refers to a patient of unknown age and gender. On an unknown date the patient was vaccinated with one dose of PNEUMOVAX 23 (lot # and dose not reported). On an unknown date (two year after the first dose of PNEUMOVAX 23, the patient received the second dose of PNEUNOVAX 23 (lot # and dose not reported). Then on an unknown date, the patient experienced swelling at injection site and overall swelling in the arm that the second dose of vaccine was administered. The patient was treated with unspecified steroids on unspecified date. At the time of report, the patient had been fully recovered. This is one of several reports received from the same source. Additional information is not expected because the reporter did not want to be contacted.
Sex: U
Vaccine: HPV4
Symptoms: Expired product administered, No adverse event
Clinical narrative: This spontaneous report as received from a healthcare worker refers to a patient of unknown age and gender. On 09-JAN-2015 the patient was vaccinated with an expired dose of GARDASIL (strength, frequency and route not reported), (lot # 0459AE, exp date 13-DEC-2014). There was no product quality complaint (PQC) involved. No adverse events were reported. Additional information has been requested.
Age: 65.0
Sex: F
Vaccine: PPV
Symptoms: Nausea, Pain in extremity, Pyrexia
Clinical narrative: Information had been received from a healthcare worker who reported that a 65 year old female with codeine allergy received a dose of PNEUMOVAX 23 (lot# K007826, expiration date 03-FEB-2016) in an unspecified arm on 24-NOV-2014. Concomitant medication included alendronate (manufacturer not specified), DIFLUCAN, estradiol, fenofibrate, PRILOSEC, WELLBUTRIN and ZOVIRAX. On 25-NOV-2014, the patient developed a high fever, nausea and stated that her arm hurts. Patient called into the office to report her symptoms but was not seen in the office. Symptoms were treated with BENADRYL and an unspecified topical biofreeze spray. It was reported that patient recoverd on 29-NOV-2014. Two additional AE cases were reported related to this same PNEUMOVAX 23 lot; Lot# K007826 exp. 03-FEB-2016 (See SR#'s 1-12956467246 and 1-12956447566). Lot check requested, please provide these results to the physician. No further information provided. Additional information has been requested.
Age: 56.0
Sex: F
Vaccine: PPV
Symptoms: Erythema, Peripheral swelling
Clinical narrative: (L) arm swelling and erythema.
Age: 62.0
Sex: F
Vaccine: VARZOS
Symptoms: Acne, Pruritus
Clinical narrative: This spontaneous report was received from a 62 year old female patient, regarding herself. Patient's pertinent medical history and drug allergies were not reported. On 29-DEC-2014 the patient was vaccinated with ZOSTAVAX. Concomitant therapies included REMERON and alprazolam. On 01-JAN-2015, patient noticed two pimple like bumps on her forehead that were red and had a white dot in the middle of them after receiving ZOSTAVAX. The bumps were located around her hair line and at her left temple. The bumps were itchy from time to time but were not consistently itchy. The patient did not seek medical attention. Outcome of the event was not reported. No product quality complaint (PQC) was involved. Causality assessment was not provided. Additional information has been requested.
Sex: U
Vaccine: HEPA
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report was received from a other health professional (nurse) refers to a patient of unknown age and gender. On 29-DEC-2014 the patient was vaccinated with improperly stored VAQTA (lot # K008252, expiration date: 24-OCT-2015), .5 ml, doses (unspecified in series) intramuscular. No adverse effects were reported. Outcome of the event was not reported. Reporter considered the event to be not related to VAQTA. This is one of several reports received from the same source (MARRS # 1501USA003826, MARRS # 1501USA004956, MARRS # 1501USA004957, MARRS # 1501USA004959 and 1501USA004960). Additional information has been requested.
Age: 70.0
Sex: F
Vaccine: PPV
Symptoms: Bronchiectasis
Clinical narrative: This spontaneous report was received from a currently 70 year old (also reported as an adult) female patient refers to herself. The patient's medical history included unspecified previous illness. On an unknown date (when the patient was 65) the patient was vaccinated with a dose of PNEUMOVAX 23 (dose, frequency, route of administration, lot# and expiration date were not reported). On an unknown date the patient experienced minor bronchiectasis which was probably not bacterial but from the unspecified previous illness. The patient also wanted to know if she should have the PCV 13. The outcome of bronchiectasis was reported as not recovered (at the time of the report). The relatedness between bronchiectasis and PNEUMOVAX 23 was not reported. Additional information has been requested.
Sex: U
Vaccine: HPV4
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report was received from a other health professional (nurse) refers to a patient of unknown age and gender. On 29-DEC-2014 the patient was vaccinated with GARDASIL (lot # K005083, expiration date: 04-NOV-2016), .5 ml, doses (unspecified in series) intramuscular. No adverse effects were reported. Outcome of the event was not reported. Reporter considered the event to be not related to GARDASIL. This is one of several reports received from the same source (MARRS # 1501USA003826, MARRS # 1501USA004956, MARRS # 1501USA004957, MARRS # 1501USA004959 and 1501USA004958). Additional information has been requested.
Sex: M
Vaccine: PPV
Symptoms: No adverse event, Wrong drug administered
Clinical narrative: Information was received from a pharmacist concerning a male patient (age not specified). The pharmacist reported that on an unspecified date the patient received a second dose of PNEUMOVAX 23, .5 ml, intramuscular. The patient had received the first dose of PNEUMOVAX 23 approximately two years prior. The patient was supposed to have been vaccinated with PREVNAR 13 instead of the PNEUMOVAX 23. No adverse effects were reported. No further information was provided. Additional information is expected.
Age: 56.0
Sex: F
Vaccine: PPV
Symptoms: Rash
Clinical narrative: Systemic rash.
Sex: U
Vaccine: HEP
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report was received from a other health professional (nurse) refers to a patient of unknown age and gender. On 08-JAN-2015 the patient was vaccinated with improperly stored RECOMBIVAX HB (lot # J007946, expiry date: 24-MAR-2016) .5 ml, doses (unspecified in series) intramuscular. No adverse effects were reported. Outcome of the event was not reported. No product quality complaint (PQC) was reported. Reporter considered the event to be not related to RECOMBIVAX HB. This is one of several reports received from the same source (MARRS # 1501USA004956, MARRS # 1501USA004957, MARRS # 1501USA004958, MARRS # 1501USA004959 and 1501USA04960). Additional information has been requested.
Sex: U
Vaccine: HPV4
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report as received from a registered nurse refers to an unspecified amount of patients of unknown age and gender. On unknown dates, the patients were vaccinated with 0.5 ml doses of GARDASIL (lot # not reported) intramuscularly that underwent a temperature excursion. No adverse effect was reported. Additional information has been requested.
Sex: U
Vaccine: HPV4
Symptoms: Inappropriate schedule of drug administration, No adverse event
Clinical narrative: This spontaneous report as received from a registered nurse refers to a patient of unknown gender and age. Medical history and concurrent conditions were not reported. On an unspecified date in 2012, the patient started series of vaccinations with GARDASIL (dose, lot/batch number, expiration date and frequency were not reported). Concomitant medications were not reported. On an unknown date (also reported as "now"), the patient was vaccinated with the third dose of GARDASIL (dose, lot/batch number, expiration date and frequency were not reported). No adverse effect was reported. Additional information has been requested.
Sex: U
Vaccine: HPV4
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report as received from a registered nurse refers to an unspecified number of patients of unknown age and gender. On an unknown date those patients were vaccinated with a dose of improperly stored GARDASIL (dose, units, route of administration and lot number were not reported). No adverse effects were noted. This is one of several reports from the same reporter. Additional information has been requested.
Sex: U
Vaccine: HPV4
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report as received from a registered nurse refers to an unspecified number of patients of unknown age and gender. On an unknown date the patients were vaccinated with improperly stored GARDASIL (lot#, expiration date, dose, frequency and route were unknown). No adverse effects was reported. This is one of several reports from the same reporter. Additional information has been requested.