chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 2.0
Sex: F
Vaccine: DTAP, HEP, IPV
Symptoms: Anaphylactic reaction, Cough, Erythema, Eyelid oedema, Face oedema
Clinical narrative: Family was waiting in exam room after vaccine administration as per our standard office policy. Approximately 2-3 minutes after vaccine administration, patient broke out in diffuse urticaria with lesions coalescing and covering most of her anterior and posterior torso with extension to her proximal extremities, neck and face. She also had facial erythema and edema, including her eyelids, lips and ears. No tongue swelling. She was coughing repeatedly and scratching at her ears and neck. She was alert and active. No cyanosis. Her lungs were clear with good aeration throughout, no increased work of breathing, and no wheezing on initial auscultation as well as on serial re-evaluations performed by me prior to EMS arrival. No vomiting. She was immediately given IM epinephrine (0.15 mg) followed by IM BENADRYL (15 mg). I prepare mother for need for transport to pediatric emergency room for ongoing treatment if needed and for ongoing close monitoring. I spoke with pediatric emergency room attending at hospital by phone to give report as well as with EMS to arrange for transportation to hospital. Patient was also given IM DECADRON (7 mg) after discussion with Dr. EMS report given upon their arrival. Patient's cough had resolved within approximately 10-15 minutes from onset of this anaphylactic reaction. She remained alert and active throughout this time period. Her hives were improving though not resolved upon discharge with EMS. Her facial erythema and edema were still present upon discharge with EMS. Mother and I had previously discussed a catch-up schedule for patient's immunizations (to include HepB#2, IPV#2 and Varicella#1 in 4 weeks, then HepB#3, IPV#3, and HepA#1 in 8 weeks) prior to this anaphylactic reaction. Mother was informed that any future vaccinations will now be deferred until further evaluation by a pediatric allergist. Mother verbalized understanding and agreement. Will file VAERS report. Addendum: I called and spoke with mother on 4/14/15 at 11:20 AM for update. She was pleased to report that patient was doing very well. She said patient was given a dose of ZANTAC in ER and observed for approximately 3 hrs before discharge home. She said all of her hives and swelling had resolved prior to discharge home. She never developed any wheezing or need for breathing treatments. She has been asymptomatic since. She also informed me that patient's fraternal twin who was also seen by me for his 2 yr WCC and received the same catch-up vaccinations at the same time as his sister ended up breaking out in some hives while with a sitter during the time period she was in the ER with patient. The sitter gave him a dose of oral BENADRYL and his hives eventually resolved that same evening and have not returned. He had no other symptoms except for the hives per mother.
Age: 2.0
Sex: F
Vaccine: DTAP, HEP, IPV
Symptoms: Lip oedema, Pruritus, Urticaria
Clinical narrative: Family was waiting in exam room after vaccine administration as per our standard office policy. Approximately 2-3 minutes after vaccine administration, patient broke out in diffuse urticaria with lesions coalescing and covering most of her anterior and posterior torso with extension to her proximal extremities, neck and face. She also had facial erythema and edema, including her eyelids, lips and ears. No tongue swelling. She was coughing repeatedly and scratching at her ears and neck. She was alert and active. No cyanosis. Her lungs were clear with good aeration throughout, no increased work of breathing, and no wheezing on initial auscultation as well as on serial re-evaluations performed by me prior to EMS arrival. No vomiting. She was immediately given IM epinephrine (0.15 mg) followed by IM BENADRYL (15 mg). I prepare mother for need for transport to pediatric emergency room for ongoing treatment if needed and for ongoing close monitoring. I spoke with pediatric emergency room attending at hospital by phone to give report as well as with EMS to arrange for transportation to hospital. Patient was also given IM DECADRON (7 mg) after discussion with Dr. EMS report given upon their arrival. Patient's cough had resolved within approximately 10-15 minutes from onset of this anaphylactic reaction. She remained alert and active throughout this time period. Her hives were improving though not resolved upon discharge with EMS. Her facial erythema and edema were still present upon discharge with EMS. Mother and I had previously discussed a catch-up schedule for patient's immunizations (to include HepB#2, IPV#2 and Varicella#1 in 4 weeks, then HepB#3, IPV#3, and HepA#1 in 8 weeks) prior to this anaphylactic reaction. Mother was informed that any future vaccinations will now be deferred until further evaluation by a pediatric allergist. Mother verbalized understanding and agreement. Will file VAERS report. Addendum: I called and spoke with mother on 4/14/15 at 11:20 AM for update. She was pleased to report that patient was doing very well. She said patient was given a dose of ZANTAC in ER and observed for approximately 3 hrs before discharge home. She said all of her hives and swelling had resolved prior to discharge home. She never developed any wheezing or need for breathing treatments. She has been asymptomatic since. She also informed me that patient's fraternal twin who was also seen by me for his 2 yr WCC and received the same catch-up vaccinations at the same time as his sister ended up breaking out in some hives while with a sitter during the time period she was in the ER with patient. The sitter gave him a dose of oral BENADRYL and his hives eventually resolved that same evening and have not returned. He had no other symptoms except for the hives per mother.
Age: 82.0
Sex: F
Vaccine: FLU3
Symptoms: Bursitis, Computerised tomogram abnormal, Musculoskeletal pain, Ultrasound scan abnormal
Clinical narrative: Unusual amount of pain in shoulder, returned to pharmacy to inquiry.
Age: 38.0
Sex: M
Vaccine: ANTH
Symptoms: Arthralgia, Asthenia, Back pain, Dizziness, Fatigue
Clinical narrative: Eyes redness and tearful eyes, joint and muscle pain, pain in the injected arm, pale skin, severe lower back pain, feeling extremely tired and weak, headache, and dizziness.
Age: 38.0
Sex: M
Vaccine: ANTH
Symptoms: Headache, Injection site pain, Lacrimation increased, Myalgia, Ocular hyperaemia
Clinical narrative: Eyes redness and tearful eyes, joint and muscle pain, pain in the injected arm, pale skin, severe lower back pain, feeling extremely tired and weak, headache, and dizziness.
Age: 38.0
Sex: M
Vaccine: ANTH
Symptoms: Pallor
Clinical narrative: Eyes redness and tearful eyes, joint and muscle pain, pain in the injected arm, pale skin, severe lower back pain, feeling extremely tired and weak, headache, and dizziness.
Age: 61.0
Sex: F
Vaccine: PPV
Symptoms: Injection site erythema, Pain in extremity, Peripheral swelling, Pyrexia
Clinical narrative: Information has been received from two nurses referring to a 61 year old female patient. The patient was allergic to sulfa, developed an unspecified rash to unspecified sulfa products on an unknown date, and received PREVNAR 13 on 26-SEP-2014. On 25-MAR-2015, the patient was vaccinated with a dose of PNEUMOVAX 23 lot # K020214, expiry date: 25-MAR-2016, 0.5 ml, intramuscularly. On the same day, the patient developed severe pain and swelling from her "shoulder to her elbow" of an unspecified arm, and had a fever of 100.5F. On 26-MAR-2015, the patient had a fever of 101.8F. On 27-MAR-2015, the fever was tested as 99.9F and at later of that afternoon, the patient had a fever of 100.2F. And on the same day, the patient developed a dark pink area at the injection site that was 2-3 inches wide. The patient sought medical attention by calling the physician's office to report her reaction on 27-MAR-2015. There was no treatment given to the events and no lab diagnostics studies were performed. The pain and swelling from the patient's shoulder to her elbow was "reduced" on 27-MAR-2015. The outcome of other events was unknown. Additional information has been requested.
Sex: U
Vaccine: HEP, HEPA, HPV4, RV5
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: Information has been received from a nurse referring to unspecified number of patients of unknown age and gender. Since unknown dates improperly stored doses of GARDASIL, VAQTA (adult doses), RECOMBIVAX HB and ROTATEQ were administered to unspecified patients. no adverse effects were reported. It was unspecified if the patients sought medical attention. This is one of several reports received from the same source. Additional information has been requested.
Sex: U
Vaccine: HEPA
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: Information has been received from a nurse referring to unspecified number of patients of unknown age and gender. Since unknown dates improperly stored doses of VAQTA (pediatric doses) were administered to unspecified patients. No adverse effects were reported. It was unspecified if the patients sought medical attention. This is one of several reports received from the same source. Additional information has been requested.
Sex: U
Vaccine: VARCEL
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: Information has been received from a nurse referring to a patient of unknown age and gender. No current or historical conditions were reported. On 02-APR-2015, the patient was vaccinated with VARIVAX (Merck), 0.5 ml, subcutaneous (lot # K003420 and expiration date 06-MAR-2015). The vaccine of VARIVAX (Merck) was post temperature excursion, which excursion was supported. No adverse effects noted. This is one of two reports from the same reporter. Additional information has been requested.
Sex: U
Vaccine: RV5
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: Information has been received from a registered nurse referring to an unspecified number of patients of unknown age and gender. On unknown dates doses of improperly stored ROTATEQ (oral, dose, lot# were not reported) were administered to these patients. No adverse effects were reported. No product quality complaint (PQC) was involved. This is one of several cases reported by the same reporter. Additional information has been requested.
Sex: M
Vaccine: HPV4
Symptoms: Inappropriate schedule of drug administration, No adverse event
Clinical narrative: This spontaneous report was received from a registered nurse and refers to a male patient of unknown age. In approximately April 2014, about a year ago, one year after the first dose of GARDASIL given approximately in April 2013, the patient was vaccinated with the second dose of GARDASIL (dose: 0.5 ml, intramuscularly, lot number and expiry date were not reported). No adverse effect was reported. Additional information has been requested.
Age: 1.3
Sex: U
Vaccine: HEPA
Symptoms: Drug administered to patient of inappropriate age, No adverse event
Clinical narrative: This spontaneous report was received from a healthcare worker and refers to a 15 month old patient of unknown gender. On 07-APR-2015, the patient was vaccinated with adult dose of VAQTA (lot # J014587, expiry date: 15-JAN-2016, dose: 1.0 ml, intramuscularly). No adverse effect was reported. Additional information has been requested.
Sex: U
Vaccine: PPV
Symptoms: Injection site reaction
Clinical narrative: Information has been received from a pharmacist via a company representative referring to unspecified number of patients of unknown age and gender. On an unknown date these patients were vaccinated with PNEUMOVAX 23 (dose, frequency and lot# were not reported). After vaccination, on an unknown date, the patients experienced injection site reactions. The outcome of injection site reaction was unknown. The relationship between the event and PNEUMOVAX 23 was not reported. It was unspecified whether these patients sought medical attention or not. No product quality complaint was involved. This is one of several cases reported by the same reporter. Additional information has been requested.
Sex: U
Vaccine: MMR
Symptoms: Expired product administered, No adverse event
Clinical narrative: This spontaneous report as received from a pharmacist refers to a patient of unknown age and gender. No information on patient's medical history and drug reactions or allergies was provided. On 03-APR-2015, the patient was inadvertently vaccinated with an expired M-M-R II expiration date 30-MAR-2015 (dose, route, anatomical location, lot # were not reported). Concomitant therapy was not provided. No adverse effects were reported. Additional information has been requested.
Age: 22.0
Sex: F
Vaccine: HPV4
Symptoms: Exposure during pregnancy, Human chorionic gonadotropin positive
Clinical narrative: This spontaneous prospective pregnancy report as received from a physician refers to a female patient of unknown age. The patient's medical history included herpes simplex type 2. The patient's concurrent condition was not provided. The patient became pregnant with her last menstrual period of 20-MAR-2015. On 30-MAR-2015 the patient performed a urine pregnancy test and the patient was not pregnant according to the results of the urine pregnancy test. On same day the patient was vaccinated with a first dose of GARDASIL (confirmed not GARDASIL 9) lot # K006095 expiry date: 02-FEB-2017 and was later found to be pregnant. Other suspect therapies included DEPO-PROVERA administered on same day. No concomitant medication was reported. Initial exposure to GARDASIL was at 1 week(s). On 31-MAR-2015 the physician reported that the patient went for a quantitative beta HCG test and this test came back positive for pregnancy. The estimated date of delivery was 25-DEC-2015. The outcome of event was unknown. The patient sought medical attention. Product quality complaint (PQC) was not reported. No further information provided. Additional information has been requested.
Age: 52.0
Sex: U
Vaccine: VARZOS
Symptoms: Hypoaesthesia
Clinical narrative: This spontaneous report as received from a pharmacist refers to a patient at the age of approximately 52 years. The patient's concurrent conditions included unspecified reaction to latex. On 07-NOV-2014, the patient was vaccinated with ZOSTAVAX (lot # K009773, expiration date 09-OCT-2015) in the left posterior arm (dose and route of administration were not provided). In February 2015, the patient experienced a softball size numbness in left arm and complained to the pharmacist. No treatment was given for the adverse event. The outcome of the event was reported as not recovered/not resolved. The relatedness between ZOSTAVAX and the adverse event was not reported. Additional information has been requested.
Age: 16.0
Sex: F
Vaccine: HPV4
Symptoms: Exposure during pregnancy, Inappropriate schedule of drug administration, No adverse event
Clinical narrative: This spontaneous report prospective report as received from a physician refers to an approximately 16 years old female patient. The patient's concurrent conditions and medical history was not reported. On 14-JAN-2015 the patient was vaccinated with the third dose of GARDASIL (Lot no. # K005881 and expiry date: 14-JAN-2017) (Dosing regimen and frequency unknown) before the patient discovered that she was pregnant (Vaccine exposure during pregnancy). Concomitant medications were not reported. On 11-OCT-2010 the patient was vaccinated with first dose of GARDASIL (lot # and expiration dates were not reported). On 12-SEP-2014 the patient was vaccinated with second dose of GARDASIL (lot # and expiration dates were not reported) and on 14-JAN-2015 was vaccinated with third dose of GARDASIL (Inappropriate schedule of vaccine administered). It was reported that the performed by the patient's unspecified obstetrician. No adverse event was reported. The patient estimated date of delivery was 12-SEP-2015. No product quality complaint (PQC) was reported. The action taken with the therapy with GARDASIL was unknown. The outcome of the events was unknown. The relatedness of the events to the therapy with GARDASIL was unknown. Additional information has been requested.
Age: 11.0
Sex: F
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 demographics. Patient's concurrent conditions or historical information were not reported. On an unspecified date in February 2015, unspecified number of patients were administered with six doses of GARDASIL (lot#K009202, expiration date: 17-DEC-2016), 0.5 ml, intramuscular, (frequencies and routes not reported) that were exposed to temperatures outside of the recommended range. No adverse effects reported. Follow up has been received. The nurse stated that 5 patients received doses of improperly stored GARDASIL (lot#K009202, expiration date: 17-DEC-2016). Additional information was received from the registered nurse, concerning one out of five patients, namely a 11 year old female patient. She was vaccinated with improperly stored (temperature excursion) GARDASIL (lot#K009202, expiration date: 17-DEC-2016), intramuscularly on 12-FEB-2015. Additional information has been requested.
Age: 12.0
Sex: F
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 demographics. Patient's concurrent conditions or historical information were not reported. On an unspecified dates in February 2015, unspecified number of patients were administered with six doses of GARDASIL (lot# K009202, expiration date: 17-DEC-2016), 0.5 ml, intramuscular, (frequencies and routes not reported) that were exposed to temperatures outside of the recommended range. No adverse effects reported. Follow up has been received. The nurse stated that 5 patients received doses of improperly stored GARDASIL (lot# K009202, expiration date: 17-DEC-2016). Additional information was received from the registered nurse, concerning one out of five patients, namely a 12 year old female patient. She was vaccinated with improperly stored (temperature excursion) GARDASIL (lot# K009202, expiration date: 17-DEC-2016), intramuscularly on 14-FEB-2015. Additional information has been requested.
Age: 11.0
Sex: M
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 demographics. Patient's concurrent conditions or historical information were not reported. On an unspecified dates in February 2015, unspecified number of patients were administered with six doses of GARDASIL (lot# K009202, expiration date: 17-DEC-2016), 0.5 ml, intramuscular, (frequencies and routes not reported) that were exposed to temperatures outside of the recommended range. No adverse effects reported. Follow up has been received. The nurse stated that 5 patients received doses of improperly stored GARDASIL (lot# K009202, expiration date: 17-DEC-2016). Additional information was received from the registered nurse, concerning one out of five patients, namely a 11 year old male patient. He was vaccinated with improperly stored (temperature excursion) GARDASIL (lot# K009202, expiration date: 17-DEC-2016), intramuscularly on 17-FEB-2015. This is one of several reports from the same reporter. Additional information has been requested.
Age: 75.0
Sex: F
Vaccine: PNC13
Symptoms: Chills, Pyrexia
Clinical narrative: Pt had PREVNAR 13 adm to left arm. Pt reported fever and chills all night. Pt didn't check temp; no temperature today.
Age: 13.0
Sex: F
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 demographics. Patient's concurrent conditions or historical information were not reported. On an unspecified dates in February 2015, unspecified number of patients were administered with six doses of GARDASIL (lot# K009202, expiration date: 17-DEC-2016), 0.5 ml, intramuscular, (frequencies and routes not reported) that were exposed to temperatures outside of the recommended range. No adverse effects reported. Follow up has been received. The nurse stated that 5 patients received doses of improperly stored GARDASIL (lot#K009202, expiration date: 17-DEC-2016). Additional information was received from the registered nurse, concerning one out of five patients, namely a 13 year old female patient. She was vaccinated with improperly stored (temperature excursion) GARDASIL (lot#K009202, expiration date: 17-DEC-20160, intramuscularly on 17-FEB-2015. This one of several reports from the same reporter. Additional information has been requested.
Age: 58.0
Sex: F
Vaccine: PNC13
Symptoms: Chills, Fatigue, Nausea, Neck pain, Pain
Clinical narrative: The evening of 4-15-15 (pt received vaccine same day). Pt started with great pain in left arm, into her neck. Extreme body aches, fatigue and nausea, chills. Treatment: Ibu 800 mg TID x 3 days.
Age: 58.0
Sex: F
Vaccine: PNC13
Symptoms: Pain in extremity
Clinical narrative: The evening of 4-15-15 (pt received vaccine same day). Pt started with great pain in left arm, into her neck. Extreme body aches, fatigue and nausea, chills. Treatment: Ibu 800 mg TID x 3 days.
Age: 1.34
Sex: M
Vaccine: DTAP, HIBV, VARCEL
Symptoms: Eczema, Injection site irritation, Injection site pruritus
Clinical narrative: Irritation and itchiness of right thigh at inj site.
Age: 2.0
Sex: F
Vaccine: HEPA, MMR, PNC13
Symptoms: Pyrexia
Clinical narrative: Fever to 101.1 evening of vaccine administration.
Age: 53.0
Sex: F
Vaccine: VARZOS
Symptoms: Headache, Injection site erythema, Injection site pain
Clinical narrative: This spontaneous report as received from a pharmacist refers to a 53 year old female patient with no medical history, drug reactions or allergies. On 31-MAR-2015, the patient was vaccinated with a dose of ZOSTAVAX (Lot#K023622, Exp. Date 20-FEB-2016) (route unspecified by reporter). Concomitant therapies included VIVELLE, BENICAR and SANCTURA. On 03-APR-2015, after receiving ZOSTAVAX, the patient developed injection site erythema and injection site pain reported as "1.5 inch area, red and tender around injection site, headache and vaccination site pain" and headache. The patient sought medical attention contacting the pharmacist. No treatment was received for the adverse events. No laboratory test was performed. The outcome of injection site erythema, vaccination site pain and headache was reported as not recovered/not resolved. No further information was provided. Additional information has been requested.
Age: 14.0
Sex: M
Vaccine: HPV4
Symptoms: Abasia, Activities of daily living impaired, Blood test, Complex regional pain syndrome, Epstein-Barr virus test
Clinical narrative: Chronic Regional Pain Syndrome - Intense pain in foot could not walk until January 2015. Multiday migraines, chronic fatigue, mononucleosis continuing. My healthy, athletic son can barely function any more.
Age: 14.0
Sex: M
Vaccine: HPV4
Symptoms: Fatigue, Infectious mononucleosis, Migraine, Nuclear magnetic resonance imaging, Pain in extremity
Clinical narrative: Chronic Regional Pain Syndrome - Intense pain in foot could not walk until January 2015. Multiday migraines, chronic fatigue, mononucleosis continuing. My healthy, athletic son can barely function any more.
Age: 27.0
Sex: F
Vaccine: HEP
Symptoms: Laceration, Scar, Syringe issue
Clinical narrative: This spontaneous report as received from a 27 year old female certified medical assistant with allergy to amoxicillin and no relevant medical history, refers to herself. Around 17-MAR-2015 or 18-MAR-2015, the reporter administered RECOMBIVAX HB (pre-filled syringe, 0.5 ml, route, lot#, expiration date and therapy type were not reported) to an unspecified patient. The reporter's concomitant medication included PROZAC. While administering the RECOMBIVAX HB, the reporter noted that "on the bottom of the RECOMBIVAX HB syringe, one side of the glass was broken, where you would hold, when administering the vaccine". The reporter stated that the unspecified patient was administered a full dose of RECOMBIVAX HB however during the actual administration of the RECOMBIVAX HB, the "broken glass" cut the reporter's middle finger on her right hand. The reporter stated that she immediately rinsed the cut out with hydrogen peroxide, put an unspecified triple antibiotic on the cut and then applied a Band-Aid. The reporter stated that the cut healed on an unspecified date, in 2015 and that she currently (at the time of the report) had a scar (onset date unspecified, in 2015). The reporter did not have any laboratory test performed and did not seek any medical attention. No adverse effect was reported for the unspecified patient that received the RECOMBIVAX HB. At the time of the report, the outcome of the scar was not recovered/not resolved. The relatedness between the events of scar and the "broken glass" cut the reporter's middle finger on her right hand and RECOMBIVAX HB was not reported. PQC (product quality complaint) was filed. Additional information has been requested.
Age: 48.0
Sex: F
Vaccine: TDAP
Symptoms: Injection site erythema, Injection site induration, Injection site pruritus, Injection site swelling, Injection site warmth
Clinical narrative: This case reported by a other health professional via call center representative and described the occurrence of injection site induration in a 48-year-old female patient who received BOOSTRIX (batch number 9924L, expiry date 14th February 2017). Concomitant products included ENBREL; TWINRIX; TYPHOID; VALTREX and INDOMETHACIN. On 23rd March 2015 13:00, the patient received BOOSTRIX (intramuscular) .5 ml. In March 2015, less than a week after receiving BOOSTRIX, the patient experienced injection site induration, injection site itching, injection site erythema, injection site swelling and injection site warmth. On an unknown date, the outcome of the injection site induration, injection site itching, injection site erythema and injection site warmth were not recovered/not resolved and the outcome of the injection site swelling was not recovered/not resolved. It was unknown if the reporter considered the injection site induration, injection site itching, injection site erythema, injection site swelling and injection site warmth to be related to BOOSTRIX. Additional information: A patient who received BOOSTRIX experienced an indurated, red, and kind of warm injection site the size of 3x5x3 cm. There was a little bit of erythema, little bit of mild swelling, and some itching. All of the patient's vital signs were fine. The nurse will be following up to confirm event resolution.
Age: 26.0
Sex: M
Vaccine: DTAPHEPBIP, HEP, HPV4, MEN, MMR, DTAPHEPBIP, HEP, HPV4, MMR, MNQ
Symptoms: Drug administered to patient of inappropriate age, Injection site pain, Neck pain, Pyrexia
Clinical narrative: This case was reported by a other health professional via call center representative and described the occurrence of inappropriate age at vaccine administration in a 26-year-old male patient who received PEDIARIX (batch number KG34F, expiry date 21st January 2017). Co-suspect products included GARDASIL, Hepatitis B vaccine, MMR and Meningococcal Group C Conjugate vaccine. On 26th February 2015, the patient received the first dose of PEDIARIX (intramuscular) .5 ml, GARDASIL, Hepatitis B vaccine, MMR and Meningococcal Group C Conjugate vaccine. On an unknown date, an unknown time after receiving PEDIARIX and Hepatitis B vaccine, the patient experienced inappropriate age at vaccine administration, injection site pain, neck pain and fever. On an unknown date, the outcome of the inappropriate age at vaccine administration, injection site pain, neck pain and fever were recovered/resolved. The reporter considered the injection site pain, neck pain and fever to be possibly related to PEDIARIX. It was unknown if the reporter considered the neck pain and fever to be related to Hepatitis B vaccine. Additional information was provided: Reporter called to state that PEDIARIX given to adult patient on 26 February 2015. Also, she mentioned that when she followed up with patient after misadministration, patient said that she was having neck pain, some pain at injection site, and fever. She feels as though these issues have resolved at this time.
Age: 26.0
Sex: M
Vaccine: DTAPHEPBIP, HEP, HPV4, MEN, MMR, DTAPHEPBIP, HEP, HPV4, MMR, MNQ
Symptoms: Injection site pain, Neck pain, Pyrexia
Clinical narrative: This case was reported by a other health professional via call center representative and described the occurrence of inappropriate age at vaccine administration in a 26-year-old male patient who received PEDIARIX (batch number KG34F, expiry date 21st January 2017). Co-suspect products included GARDASIL, Hepatitis B vaccine, MMR and Meningococcal Group C Conjugate vaccine. On 26th February 2015, the patient received the first dose of PEDIARIX (intramuscular) .5 ml, GARDASIL, Hepatitis B vaccine, MMR and Meningococcal Group C Conjugate vaccine. On an unknown date, an unknown time after receiving PEDIARIX and Hepatitis B vaccine, the patient experienced inappropriate age at vaccine administration, injection site pain, neck pain and fever. On an unknown date, the outcome of the inappropriate age at vaccine administration, injection site pain, neck pain and fever were recovered/resolved. The reporter considered the injection site pain, neck pain and fever to be possibly related to PEDIARIX. It was unknown if the reporter considered the neck pain and fever to be related to Hepatitis B vaccine. Additional information was provided: Reporter called to state that PEDIARIX given to adult patient on 26 February 2015. Also, she mentioned that when she followed up with patient after misadministration, patient said that she was having neck pain, some pain at injection site, and fever. She feels as though these issues have resolved at this time.
Age: 30.0
Sex: F
Vaccine: FLU3
Symptoms: Chest discomfort, Cough, Dyspnoea
Clinical narrative: Approximately 2 hours after IM flu shot, developed wet cough, dyspnea, chest pressure and inability to expand lung volume. Seen at ER for anaphylaxis. Inhaled epi, long acting B2 were palliative.
Age: 21.0
Sex: M
Vaccine: HPV4, TDAP
Symptoms: Dizziness, Hyperhidrosis, Hypotension, Nausea, Vomiting
Clinical narrative: Dizziness, Nausea/Vomiting, hypotension, diaphoresis. Patient was laying down, oxygen was applied via nasal cannula at 2 liters. Signs and symptoms lasted for approximately 10 minutes.
Age: 87.0
Sex: F
Vaccine: PPV
Symptoms: Injection site erythema, Injection site pain, Injection site pruritus
Clinical narrative: Redness, itching, heat, and soreness near site of inoculation.
Sex: F
Vaccine: RVX
Symptoms: Dermatitis diaper, Frequent bowel movements
Clinical narrative: This case was reported by a consumer via GSK/market research programs and described the occurrence of frequent bowel movements in a female who received Rotavirus vaccine. On an unknown date, the patient received Rotavirus vaccine at an unknown dose. On an unknown date, an unknown time after receiving Rotavirus vaccine, the patient experienced frequent bowel movements and diaper rash. On an unknown date, the outcome of the frequent bowel movements and diaper rash were unknown. It was unknown if the reporter considered the frequent bowel movements and diaper rash to be related to Rotavirus vaccine.
Sex: M
Vaccine: HEPAB
Symptoms: Faeces discoloured
Clinical narrative: This case was reported by a pharmacist via call center representative and described the occurrence of stool discolored in a male patient who received TWINRIX. In March 2015, the patient received the 4th dose of TWINRIX. In March 2015, less than a week after receiving TWINRIX, the patient experienced stool discolored. On an unknown date, the outcome of stool discolored was not recovered/not resolved. It was unknown id the reporter considered the stool discolored to be related to TWINRIX. The patient received a 4th dose of TWINRIX a few days before reporting and the patient reported yellow stools ever since that dose. The reporter stated that follow up can be conducted.
Age: 1.31
Sex: M
Vaccine: DTAP, HEPA, HIBV
Symptoms: Injection site erythema, Injection site oedema, Injection site warmth
Clinical narrative: Pt. rec'd 15 mo immunizations at 4-14-15 WCE in office. Developed redness, edema and warmth to (Lt) thigh that evening. Seen in office for s/s on 04/15/15 and Dx with adverse rxn to DTaP. Tx with ice, ibuprofen-return PRN.
Age: 57.0
Sex: F
Vaccine: VARZOS, VARZOS
Symptoms: Blood test, Injection site nodule, Peripheral swelling, Skin discolouration
Clinical narrative: Onset 4/11/15. Pt states she noted her arm to have a knot at the injection site and arm was swelled. Also noted as she called skin that looked "mottled" inside legs, rt buttocks. Went to MD Monday 4/13/15 had blood work done all ok.
Age: 57.0
Sex: F
Vaccine: VARZOS, VARZOS
Symptoms: C-reactive protein normal, Erythema, Feeling cold, Full blood count normal, Injection site pruritus
Clinical narrative: Onset 4/11/15. Pt states she noted her arm to have a knot at the injection site and arm was swelled. Also noted as she called skin that looked "mottled" inside legs, rt buttocks. Went to MD Monday 4/13/15 had blood work done all ok.
Age: 57.0
Sex: F
Vaccine: VARZOS, VARZOS
Symptoms: Injection site rash, Injection site swelling, Metabolic function test normal, Peripheral coldness, Platelet count normal
Clinical narrative: Onset 4/11/15. Pt states she noted her arm to have a knot at the injection site and arm was swelled. Also noted as she called skin that looked "mottled" inside legs, rt buttocks. Went to MD Monday 4/13/15 had blood work done all ok.
Age: 57.0
Sex: F
Vaccine: VARZOS, VARZOS
Symptoms: Pruritus, Rash, Red blood cell sedimentation rate normal, Skin discolouration, Skin exfoliation
Clinical narrative: Onset 4/11/15. Pt states she noted her arm to have a knot at the injection site and arm was swelled. Also noted as she called skin that looked "mottled" inside legs, rt buttocks. Went to MD Monday 4/13/15 had blood work done all ok.
Age: 57.0
Sex: F
Vaccine: VARZOS, VARZOS
Symptoms: Skin swelling
Clinical narrative: Onset 4/11/15. Pt states she noted her arm to have a knot at the injection site and arm was swelled. Also noted as she called skin that looked "mottled" inside legs, rt buttocks. Went to MD Monday 4/13/15 had blood work done all ok.
Age: 81.0
Sex: F
Vaccine: PNC13
Symptoms: Injection site erythema, Injection site pruritus
Clinical narrative: Itching and redness at injection site.
Age: 60.0
Sex: F
Vaccine: TDAP
Symptoms: Herpes zoster, Pain, Rash erythematous
Clinical narrative: Tdap given 03/30/2015, on 04/03/2015 had outbreak of painful erythematous rash on left neck and shoulder consistent with shingles -> given acyclovir for tx as within first 24 hrs presentation.
Age: 61.0
Sex: F
Vaccine: PPV, VARZOS
Symptoms: Injection site erythema, Pain in extremity, Pruritus, Skin warm
Clinical narrative: Arm felt itchy, painful and warm. Red at injection site. Pt react to the PNEUMOVAX vaccine.
Age: 4.0
Sex: F
Vaccine: DTAPIPV, MMRV
Symptoms: Cellulitis, Erythema, Local reaction, Pain, Swelling
Clinical narrative: Localized rxn with swelling, pain and redness. Mild cellulitis Rx cephalexin and mupirocin.
Age: 15.0
Sex: F
Vaccine: HPV4, MNQ
Symptoms: Arthralgia
Clinical narrative: Mom states patient developed joint pain, after the vaccine, which included her arms/shoulder and knees.
Age: 27.0
Sex: M
Vaccine: JEV1, TYP, YF
Symptoms: Arthralgia, Erythema, Localised oedema
Clinical narrative: Pt states approx. 24 hours after recieving Yellow Fever vaccine in outer aspect of Left Arm, local erythema and edema was noted approx 40mm in diameter. Pt states he also noted joint aches around the same time and still reports these symptoms. Pt states he is unsure if his joint aches are related to the vaccine.
Age: 40.0
Sex: F
Vaccine: MMR
Symptoms: Erythema, Pain, Pyrexia
Clinical narrative: Fever-100.8, reddened site, sore site.
Age: 36.0
Sex: M
Vaccine: HEP, MMR
Symptoms: Wrong drug administered
Clinical narrative: Patient was given an MMR immunization that he wasn't required to have.  There was serological testing already done for the immunizations he was given.
Age: 64.0
Sex: M
Vaccine: TDAP
Symptoms: Chills, Influenza virus test negative, Pain, Sleep disorder
Clinical narrative: Severe body aches keeping him from sleeping; possible fever; chills.
Age: 4.0
Sex: M
Vaccine: DTAP, VARCEL
Symptoms: Gait disturbance, Peripheral swelling
Clinical narrative: Swollen leg, could barely walk.
Age: 4.0
Sex: M
Vaccine: DTAP
Symptoms: Peripheral swelling
Clinical narrative: Swollen leg.
Age: 27.0
Sex: F
Vaccine: TDAP
Symptoms: Abdominal discomfort, Chills, Decreased appetite, Dizziness, Hyperhidrosis
Clinical narrative: Arm started to hurt at site of injection. Next morning, arm still hurting, vomiting, upset stomach, not able to eat much. Next morning, chills and sweats, dizziness, arm hurts worse and muscle swollen around injection site. Still very nauseous, not able to eat much. Still very tired. Unable to work.
Age: 27.0
Sex: F
Vaccine: TDAP
Symptoms: Impaired work ability, Injection site pain, Injection site reaction, Muscle swelling, Nausea
Clinical narrative: Arm started to hurt at site of injection. Next morning, arm still hurting, vomiting, upset stomach, not able to eat much. Next morning, chills and sweats, dizziness, arm hurts worse and muscle swollen around injection site. Still very nauseous, not able to eat much. Still very tired. Unable to work.
Age: 27.0
Sex: F
Vaccine: TDAP
Symptoms: Pain in extremity
Clinical narrative: Arm started to hurt at site of injection. Next morning, arm still hurting, vomiting, upset stomach, not able to eat much. Next morning, chills and sweats, dizziness, arm hurts worse and muscle swollen around injection site. Still very nauseous, not able to eat much. Still very tired. Unable to work.
Age: 76.0
Sex: F
Vaccine: VARZOS
Symptoms: Arthropod bite, Injection site erythema, Injection site rash, Rash erythematous
Clinical narrative: Red rash at injection site and on lower back, pt also simultaneously suffered a tick bite.
Age: 13.0
Sex: M
Vaccine: HEPA
Symptoms: Drug administered to patient of inappropriate age
Clinical narrative: Pt was given the adult dose of hepatitis A vaccine. This dose was given due to his age and size, was not aware that he needed the pediatric dose.
Age: 38.0
Sex: M
Vaccine: ANTH, MMR, VARCEL
Symptoms: Headache, Injection site erythema, Injection site swelling, Injection site warmth, Skin tightness
Clinical narrative: Left deltoid is red, swollen, skin is warm to touch and tight.  Pt denies any nausea/vomiting/diarrhea.  Pt states he started feeling a "low headache in the background" starting today (4/16/2015).
Age: 1.03
Sex: M
Vaccine: HEPA, MMR, PNC13
Symptoms: Blood culture, Culture throat, Diarrhoea, Full blood count, Influenza virus test
Clinical narrative: Fever for 2 days highest temp 105.1 Temporal, given Tylenol and Motrin.  c/o Rhinorrhea for 2 days clear in color. Cranky with fever. Wanting to play now as fever is down.  Denies: Cough. Ear pain. Nasal congestion. Feeding difficulty. c/o Diarrhea for 1 day had one episode this AM, watery, no blood or mucous. Denies: Vomiting. Denies: Rash.
Age: 1.03
Sex: M
Vaccine: HEPA, MMR, PNC13
Symptoms: Irritability, Pyrexia, Rhinorrhoea, Streptococcus test
Clinical narrative: Fever for 2 days highest temp 105.1 Temporal, given Tylenol and Motrin.  c/o Rhinorrhea for 2 days clear in color. Cranky with fever. Wanting to play now as fever is down.  Denies: Cough. Ear pain. Nasal congestion. Feeding difficulty. c/o Diarrhea for 1 day had one episode this AM, watery, no blood or mucous. Denies: Vomiting. Denies: Rash.
Age: 11.0
Sex: M
Vaccine: TDAP
Symptoms: Headache, Injection site urticaria, Rash
Clinical narrative: Guardian said he had baseball size welt at injection site, developed headache on Friday (4/10) which continued on Saturday and Sunday.  Developed rash on arms and legs on Monday (4/16).  Physician prescribed Zyrtec on 4/16/2015.
Age: 71.0
Sex: M
Vaccine: PPV
Symptoms: Inflammation, Musculoskeletal stiffness, Pain in extremity, Rash
Clinical narrative: WAS GIVEN PNEUMOVAX 23 INJECTION ON LEFT ARM INTRAMUSCULAR, THE NEXT DAY PATIENT'S ARM BECAME INFLAMED, ABOUT AN INCH ABOVE THE ELBOW AND DOWN TO HIS FOREARM, PATIENT SAID HE COULD NOT STRAIGHTEN OUT ARM DUE TO PAIN. INFLAMED, RASH. LASTED OVER TEN DAYS.
Age: 54.0
Sex: F
Vaccine: DTAP
Symptoms: Incorrect route of drug administration, Pain
Clinical narrative: Tdap given SQ instead of IM patient had concerns about soreness/effectiveness. Rph contacted mfg to find out if re-admin. is necessary and they said no, it will still be effective.
Age: 14.0
Sex: F
Vaccine: HPV4
Symptoms: Chest pain, Fatigue, Pain, Palpitations, Postural orthostatic tachycardia syndrome
Clinical narrative: After shot 3 started having chest pains and racing heart and severe tiredness and aching body. Went to ER multiple times. Started having syncope and non epileptic seizures in January 2015.  3-5-2015 diagosed with Postural Orthostatic tachycardia syndrome.
Age: 14.0
Sex: F
Vaccine: HPV4
Symptoms: Seizure, Syncope
Clinical narrative: After shot 3 started having chest pains and racing heart and severe tiredness and aching body. Went to ER multiple times. Started having syncope and non epileptic seizures in January 2015.  3-5-2015 diagosed with Postural Orthostatic tachycardia syndrome.
Age: 1.67
Sex: M
Vaccine: YF
Symptoms: Febrile convulsion
Clinical narrative: Febrile Seizure.
Age: 11.0
Sex: U
Vaccine: MNQ
Symptoms: Wrong technique in drug usage process
Clinical narrative: I gave the powder component with the sterile diluent to the patient.
Age: 4.0
Sex: F
Vaccine: MMR, VARZOS, VARCEL, VARZOS
Symptoms: Wrong drug administered
Clinical narrative: Pt was administered ZOSTAVAX instead of Varicella.
Age: 4.0
Sex: F
Vaccine: MMR, VARZOS, VARCEL, VARZOS
Symptoms: No adverse event, Wrong drug administered
Clinical narrative: Pt was administered ZOSTAVAX instead of Varicella.
Age: 50.0
Sex: F
Vaccine: FLU3, PPV
Symptoms: Cellulitis, Injection site erythema, Injection site oedema
Clinical narrative: The area are red and a little edema in the area of the left deltoid. The patient was oriented about how manage the area when vaccine was adminsitered to put ice in the area. Prescription was given and patient as evaluated by the doctor.
Age: 88.0
Sex: M
Vaccine: FLU3
Symptoms: Arthralgia, Balance disorder, Blood test, Computerised tomogram, Confusional state
Clinical narrative: Coughing three weeks 24/7, joint pain severe, poor balance, fell-cut head in bathroom 4:30 AM, total mental confusion. Hospitalized. Severe pain all joints. Sensitive skin. Several trips to E.R. Blood work, X Rays, CAT scan. Scalp surgery (minor) pain still is worse.
Age: 88.0
Sex: M
Vaccine: FLU3
Symptoms: Cough, Electrocardiogram, Fall, Hyperaesthesia, Immunology test
Clinical narrative: Coughing three weeks 24/7, joint pain severe, poor balance, fell-cut head in bathroom 4:30 AM, total mental confusion. Hospitalized. Severe pain all joints. Sensitive skin. Several trips to E.R. Blood work, X Rays, CAT scan. Scalp surgery (minor) pain still is worse.
Age: 88.0
Sex: M
Vaccine: FLU3
Symptoms: Laboratory test, Laceration, Pain of skin, Surgery, X-ray
Clinical narrative: Coughing three weeks 24/7, joint pain severe, poor balance, fell-cut head in bathroom 4:30 AM, total mental confusion. Hospitalized. Severe pain all joints. Sensitive skin. Several trips to E.R. Blood work, X Rays, CAT scan. Scalp surgery (minor) pain still is worse.
Age: 48.0
Sex: F
Vaccine: MMR
Symptoms: Chills, Flushing, Generalised erythema, Injection site erythema, Injection site swelling
Clinical narrative: 2 days after vaccine, noted flushed neck and face; had chills for 2 nights prior. Injection site red raised and generalized redness over arm, neck, chest, thighs, back.
Age: 86.0
Sex: F
Vaccine: FLU3
Symptoms: Insomnia, Pain
Clinical narrative: Very painful for 4 months stilll have a lot of pain, putting on clothes, reaching, pulling up pants. Also, can't sleep on side of flu shot. I didn't go to my dr. I knew it was from the flu shot. Take ALEVE at night.
Age: 64.0
Sex: M
Vaccine: FLU3
Symptoms: Hypoaesthesia, Injection site pain, Muscular weakness, Musculoskeletal pain, Pain
Clinical narrative: Pain w/in hours. Flu vaccine given in Distal (R) Deltoid. Developed marked pain in deltoid/scapula and pain radiating into hand with subsequent numbness weakness as noted.
Age: 64.0
Sex: M
Vaccine: FLU3
Symptoms: Pain in extremity, Paraesthesia
Clinical narrative: Pain w/in hours. Flu vaccine given in Distal (R) Deltoid. Developed marked pain in deltoid/scapula and pain radiating into hand with subsequent numbness weakness as noted.
Age: 1.33
Sex: M
Vaccine: MMR, VARZOS
Symptoms: Wrong drug administered
Clinical narrative: Pt was to receive Varicella vaccine at appt. but was given ZOSTAVAX.
Age: 4.0
Sex: F
Vaccine: DTAPIPV, MMRV
Symptoms: Injection site erythema, Injection site swelling
Clinical narrative: Erythema, swelling at site 8 cm x 6 cm (L) deltoid BENADRYL prn - monitor f/u prn.
Age: 69.0
Sex: F
Vaccine: UNK
Symptoms: Fatigue, Injection site paraesthesia, Injection site swelling, Injection site warmth, Local reaction
Clinical narrative: No adverse rxn the day the injection was given. Fatigue the day after the injection was administered. Localized reaction that is swollen, warm, and tingles just below the injection site on the left deltoid. Cool compresses-swelling and hydrocortisone cream-redness.
Age: 27.0
Sex: F
Vaccine: TDAP
Symptoms: Erythema, Feeling hot, Immediate post-injection reaction, Skin warm, Swelling
Clinical narrative: Swelling, redness, warmth within 1 minute of vaccine administration. Improved after 25 mg BENADRYL given and ice pack to site.
Age: 73.0
Sex: M
Vaccine: PNC13
Symptoms: Local swelling, Pain
Clinical narrative: Local swelling and pain a few hours after injection. Fever.
Age: 68.0
Sex: F
Vaccine: PNC13
Symptoms: Headache, Myalgia, Pyrexia, Tenderness
Clinical narrative: Local tenderness and muscle aches within a couple of hours of injection. Fever and headache.
Age: 4.0
Sex: M
Vaccine: DTAP
Symptoms: Abscess limb, Cellulitis, Injection site erythema, Injection site pruritus
Clinical narrative: Itchy, redness, has spread around area where vaccine was administered. Symptoms started 4-13.
Age: 14.0
Sex: F
Vaccine: MMRV, MNQ, VARCEL
Symptoms: Extra dose administered
Clinical narrative: Nurse administered varicella and MMRV at same visit.
Age: 61.0
Sex: M
Vaccine: PPV
Symptoms: Chills, Injection site erythema
Clinical narrative: Had redness/erythema- left biceps-site of injection no abscess ROM (Nl), Chills x 10 mins x 1 night no SOB no hematur no LP no seizures.
Age: 0.17
Sex: F
Vaccine: DTAPIPVHIB, HEP, PNC13, RV5
Symptoms: Injection site swelling
Clinical narrative: Right leg swelling, approximately 20% larger than left leg. Pt given acetaminophen. No erythema or rash. No fever of fussiness.
Age: 93.0
Sex: F
Vaccine: PNC13
Symptoms: Injection site erythema, Injection site pain, Injection site swelling, Injection site warmth, Pain in extremity
Clinical narrative: Pt.'s arm started to get painful around bedtime on 4/15/15. Pt. noticed some redness and swelling at site. Site warm to touch and red. Area of redness is from top of shoulder to almost elbow, 8 inches and width of redness is 6 inches wide at widest point of muscle. Pt. states tender to touch.
Age: 10.0
Sex: F
Vaccine: TDAP
Symptoms: Injection site erythema, Rash, Rash papular, Vaccination site swelling, Vaccination site warmth
Clinical narrative: Swelling/redness/warmth to vaccine site and papular rash to face and arms. TX w/ NSAID and antihistamine.
Age: 0.82
Sex: F
Vaccine: DTAPIPVHIB, FLU3, HEP, PNC13
Symptoms: Body temperature increased, Febrile convulsion
Clinical narrative: Febrile seizures with temp 103.1 per ER. TYL/MOTRIN given at ER.
Age: 9.0
Sex: U
Vaccine: VARCEL
Symptoms: Incorrect route of drug administration
Clinical narrative: Varicella was administrated intramuscular. When it was supposed to be administrated subcutaneous.