chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 77.0
Sex: F
Vaccine: VARZOS, VARZOS
Symptoms: Peripheral swelling, X-ray
Clinical narrative: 9/16/18 Went to pharmacy. Shindrex vaccine was given on upper left arm. Within 1 hour after, I felt puffiness, redness and hardness on injection sight & to the left of injection sight. The pharmacy stated that it will go away after 3 days. It did start going away with in that time frame. Around 9/17/18 I felt a burning pain started from the left middle finger all the way up my left arm and up to my neck. On 9/18/18 I felt burning pain and tingling in both arms. The next night on 9/19/18 I felt the same burning pain and tingling and could not sleep for 3 nights in a row, I continued to have swelling in my fingers, stiffness and pain, and sometimes unable to close my hands. At night the pain is so severe that I have to get out of bed and either take pain medication, stretch, massage and drink nettle tea, tart cherry etc, in an attempt to relieve the pain. The pain is still a daily intermittent occurrence but worse at night, on the injection sight and in both arms. Mostly in the right hand and weakness in both hands. I  can not sleep most nights. Sometimes I can feel pain throughout my body.
Age: 77.0
Sex: F
Vaccine: VARZOS, VARZOS
Symptoms: Carpal tunnel syndrome, Injection site pain, Neck pain, Nerve injury, Peripheral swelling
Clinical narrative: 9/16/18 Went to pharmacy. Shindrex vaccine was given on upper left arm. Within 1 hour after, I felt puffiness, redness and hardness on injection sight & to the left of injection sight. The pharmacy stated that it will go away after 3 days. It did start going away with in that time frame. Around 9/17/18 I felt a burning pain started from the left middle finger all the way up my left arm and up to my neck. On 9/18/18 I felt burning pain and tingling in both arms. The next night on 9/19/18 I felt the same burning pain and tingling and could not sleep for 3 nights in a row, I continued to have swelling in my fingers, stiffness and pain, and sometimes unable to close my hands. At night the pain is so severe that I have to get out of bed and either take pain medication, stretch, massage and drink nettle tea, tart cherry etc, in an attempt to relieve the pain. The pain is still a daily intermittent occurrence but worse at night, on the injection sight and in both arms. Mostly in the right hand and weakness in both hands. I  can not sleep most nights. Sometimes I can feel pain throughout my body.
Age: 77.0
Sex: F
Vaccine: VARZOS, VARZOS
Symptoms: Surgery
Clinical narrative: 9/16/18 Went to pharmacy. Shindrex vaccine was given on upper left arm. Within 1 hour after, I felt puffiness, redness and hardness on injection sight & to the left of injection sight. The pharmacy stated that it will go away after 3 days. It did start going away with in that time frame. Around 9/17/18 I felt a burning pain started from the left middle finger all the way up my left arm and up to my neck. On 9/18/18 I felt burning pain and tingling in both arms. The next night on 9/19/18 I felt the same burning pain and tingling and could not sleep for 3 nights in a row, I continued to have swelling in my fingers, stiffness and pain, and sometimes unable to close my hands. At night the pain is so severe that I have to get out of bed and either take pain medication, stretch, massage and drink nettle tea, tart cherry etc, in an attempt to relieve the pain. The pain is still a daily intermittent occurrence but worse at night, on the injection sight and in both arms. Mostly in the right hand and weakness in both hands. I  can not sleep most nights. Sometimes I can feel pain throughout my body.
Age: 4.0
Sex: M
Vaccine: DTAPIPV
Symptoms: Injection site erythema, Injection site vesicles
Clinical narrative: upper lateral arm area : confluence of vesicles about size of a quarter surrounded by erythema. No weeping lesions
Age: 2.0
Sex: F
Vaccine: DTAPIPV, HEPA, PNC13
Symptoms: Product administered to patient of inappropriate age
Clinical narrative: PATIENT WAS GIVEN A VACCINE (DTAP-IPV) THAT IS NOT ADVISED FOR CHILDREN UNDER 4 YEARS OF AGE. NO COMPLICATIONS WITH INJECTION WERE REPORTED.
Age: 68.0
Sex: F
Vaccine: VARZOS
Symptoms: Dizziness, Headache, Injection site erythema, Injection site swelling, Nausea
Clinical narrative: Dizzy within 20 minutes of receiving the vaccine which lasted the duration of the day vaccine was administered. Headache and nausea for 24 hours after  vaccine given. Patient was able to treat with Aleve. Patient also reports an injection site reaction (red, raised bump) that started yesterday evening and is continuing through today.
Age: 52.0
Sex: M
Vaccine: MMR, MMR
Symptoms: Incorrect route of product administration
Clinical narrative: no adverse event reported---no reaction verified with patient 5/23/19--vaccination was administered intramuscularly vs subcutaneously as recommended but per merck vaccination should be effective and no additional measures necessary
Age: 52.0
Sex: M
Vaccine: MMR, MMR
Symptoms: No adverse event, Product administered at inappropriate site
Clinical narrative: no adverse event reported---no reaction verified with patient 5/23/19--vaccination was administered intramuscularly vs subcutaneously as recommended but per merck vaccination should be effective and no additional measures necessary
Age: 76.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site pain, Injection site swelling
Clinical narrative: The patient experienced swelling at the injection site and tenderness/soreness for several days thereafter.
Age: 11.0
Sex: M
Vaccine: HPV9, MNQ, TDAP
Symptoms: Fall, Syncope
Clinical narrative: Pt fainted after standing up after receiving imms. Fell into wall and was lowered to ground. Pt was observed in clinic and given juice/fluids. BP stabilized.
Age: 76.0
Sex: F
Vaccine: VARZOS
Symptoms: Chills, Injection site pain, Injection site swelling, Pyrexia
Clinical narrative: patient reported at 24 hours after injection pain at injection site and low-grade fever chills (did not give temperature).  after 72 hours, fever/chills went away, but injection site showed visible swelling and tender to touch.  swelling area was about 4x2 inch area around injection site.
Age: 47.0
Sex: F
Vaccine: UNK
Symptoms: Circumstance or information capable of leading to medication error, Hypoaesthesia, Injection site discomfort, Injection site pain
Clinical narrative: Customer received a flu shot on Jan 27, 2019. She claims that the pharmacist was too busy running around doing several things and was not focused on her when administering the vaccine. She said the shot was painful and she experienced soreness around the injection site for several weeks. She also says that after she received the shot she began experiencing constant numbness in her arm and especially her left hand. This numbness is still an issue for her and she is scheduled to see a neurologist next month. She mentioned that she was documenting our conversation. She did not  specifically say, but it seems she will be looking for compensation.
Age: 60.0
Sex: M
Vaccine: VARZOS
Symptoms: Chills, Discomfort, Fatigue, Pain, Pyrexia
Clinical narrative: chills, tired, fever-like feeling, body felt sore, quite uncomfortable
Age: 65.0
Sex: M
Vaccine: VARZOS
Symptoms: Fatigue, Headache, Pain, Pain in extremity, Paraesthesia
Clinical narrative: Extreme arm soreness (as if someone was hitting my arm with a bat repeatedly for first two hours after shot; prickly skin as if I had a low grade fever, headache, sensitivity to light, fatigue, aches all over- headache and sense of fever for two days, aches and soreness for 3 days.
Age: 65.0
Sex: M
Vaccine: VARZOS
Symptoms: Photophobia, Pyrexia
Clinical narrative: Extreme arm soreness (as if someone was hitting my arm with a bat repeatedly for first two hours after shot; prickly skin as if I had a low grade fever, headache, sensitivity to light, fatigue, aches all over- headache and sense of fever for two days, aches and soreness for 3 days.
Age: 72.0
Sex: F
Vaccine: VARZOS
Symptoms: Antinuclear antibody, Blood thyroid stimulating hormone, Burning sensation, C-reactive protein increased, Full blood count
Clinical narrative: On 4/5/2019 Pneumococcal 23 in OUR office left ARM Lot # R031961 Slight tender. Received Shingrix Vaccine ON 4/23/19.  Woke up middle of night pneumococcal site "on fire" Body aches fever foR 1 month abnormal liver, renal function and elevated CRP and Sed rate with muscle weakness
Age: 72.0
Sex: F
Vaccine: VARZOS
Symptoms: Liver function test abnormal, Metabolic function test, Middle insomnia, Muscular weakness, Pain
Clinical narrative: On 4/5/2019 Pneumococcal 23 in OUR office left ARM Lot # R031961 Slight tender. Received Shingrix Vaccine ON 4/23/19.  Woke up middle of night pneumococcal site "on fire" Body aches fever foR 1 month abnormal liver, renal function and elevated CRP and Sed rate with muscle weakness
Age: 72.0
Sex: F
Vaccine: VARZOS
Symptoms: Pyrexia, Reaction to previous exposure to any vaccine, Red blood cell sedimentation rate increased, Renal impairment, Rheumatoid factor
Clinical narrative: On 4/5/2019 Pneumococcal 23 in OUR office left ARM Lot # R031961 Slight tender. Received Shingrix Vaccine ON 4/23/19.  Woke up middle of night pneumococcal site "on fire" Body aches fever foR 1 month abnormal liver, renal function and elevated CRP and Sed rate with muscle weakness
Age: 40.0
Sex: F
Vaccine: TDAP
Symptoms: Injection site pain
Clinical narrative: Patient given TDaP into Right deltoid on 5/9/19 after explaining side effects and giving verbal consent. Administration was well tolerated and uncomplicated. Patient noted continued Right shoulder pain on 05/21/19. Patient was referred to orthopedic shoulder specialist for evaluation and treatment.
Age: 67.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site pain, Pain
Clinical narrative: Moderate pain at injection site; generalized upper arm/shoulder pain when arm is raised
Age: 54.0
Sex: F
Vaccine: VARZOS
Symptoms: Inflammation, Injection site pain, Rash erythematous
Clinical narrative: red rash, painful @ injection site, inflamed
Age: 50.0
Sex: F
Vaccine: TDAP
Symptoms: Peripheral swelling, Rash generalised
Clinical narrative: Patient broke in RAsh, swelling in hands and feet. RASH All over Body
Age: 11.0
Sex: M
Vaccine: HEPA, HPV9, MENB, MNQ, TDAP
Symptoms: Anion gap increased, Blood glucose normal, Haemoglobin normal, Lethargy, Malaise
Clinical narrative: Anion Gap 19.6; Glucose 130; HGB 13.6; feeling lethargic; generalized malaise; a near syncope episode at home; U/A-Trace Protein & Ketones 40; U/A-Trace Protein & Ketones 40; CBC showed WBC 16.0; This report was identified from a line listing obtained on request by the Company from the FDA (Agency # 703440) under the Act on 13-DEC-2017, concerning an 11 year old male patient. The patient had no active medications, current illnesses or any medical history.  On 10-JUL-2017, the patient was vaccinated with the second dose of hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast) (GARDASIL 9), lot # M024261, expiration date 30-JUL-2018, intramuscular in the right arm (dose was not reported), the second dose of meningococcal b rfhbp vaccine (e. coli) (TRUMENBA) lot # R45078, intramuscular in the left arm (dose and expiration date were not reported), the second dose of diphtheria toxoid, pertussis acellular 5-component vaccine, tetanus toxoid (ADACEL) lot # U5472AA, intramuscular in the left arm (dose and expiration date were not reported), the second dose of meningococcal acyw conj vaccine (dip toxoid) (MENACTRA) lot # U5463AA, intramuscular in the right arm (dose and expiration date were not reported) and the second dose of hepatitis a virus vaccine inactivated(HAVRIX) lot # 9TS3T, intramuscular in the right arm (dose and expiration date were not reported) for prophylaxis.   On 11-JUL-2017, the patient was seen in the emergency room due to feeling lethargic, generalized malaise and a near syncope episode at home. Basic metabolic panel (BMP), complete blood count (CBC) and urine analysis (U/A) completed on 11-JUL-2017 and had the following abnormal results: U/A-trace protein (protein urine present) and ketones (urine ketone body present) 40 (units not provided), BMP-glucose 130 (units not provided) (blood glucose normal) and anion gap 19.6 (units not provided) (anion gap), CBC showed white blood cell count (WBC) 16.0 (units not provided) (white blood cell count increased) and hemoglobin (HGB) 13.6 (units not provided) (haemoglobin normal).   The outcome of the events was unknown. The causality assessment of the events was not reported.  Follow-up information has been received on 15-APR-2019 from FDA (Agency # 703440). The patient's demographics were updated. The date of the vaccination was updated to 10-JUL-2017 at 08:35. The onset date was updated to 11-JUL-2017 at 19:54. The information about the facility where the vaccination was given were updated. The patient had no adverse event following any previous vaccinations.  Follow up information has been received on 23-MAY-2019 from health care professional. The reporter reported that she did not have an 11 year old patient vaccinated on 15-APR-2018. The caller stated she would research and call back if she was able to find any further information.
Age: 11.0
Sex: M
Vaccine: HEPA, HPV9, MENB, MNQ, TDAP
Symptoms: Presyncope, Protein urine present, Urine ketone body present, White blood cell count increased
Clinical narrative: Anion Gap 19.6; Glucose 130; HGB 13.6; feeling lethargic; generalized malaise; a near syncope episode at home; U/A-Trace Protein & Ketones 40; U/A-Trace Protein & Ketones 40; CBC showed WBC 16.0; This report was identified from a line listing obtained on request by the Company from the FDA (Agency # 703440) under the Act on 13-DEC-2017, concerning an 11 year old male patient. The patient had no active medications, current illnesses or any medical history.  On 10-JUL-2017, the patient was vaccinated with the second dose of hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast) (GARDASIL 9), lot # M024261, expiration date 30-JUL-2018, intramuscular in the right arm (dose was not reported), the second dose of meningococcal b rfhbp vaccine (e. coli) (TRUMENBA) lot # R45078, intramuscular in the left arm (dose and expiration date were not reported), the second dose of diphtheria toxoid, pertussis acellular 5-component vaccine, tetanus toxoid (ADACEL) lot # U5472AA, intramuscular in the left arm (dose and expiration date were not reported), the second dose of meningococcal acyw conj vaccine (dip toxoid) (MENACTRA) lot # U5463AA, intramuscular in the right arm (dose and expiration date were not reported) and the second dose of hepatitis a virus vaccine inactivated(HAVRIX) lot # 9TS3T, intramuscular in the right arm (dose and expiration date were not reported) for prophylaxis.   On 11-JUL-2017, the patient was seen in the emergency room due to feeling lethargic, generalized malaise and a near syncope episode at home. Basic metabolic panel (BMP), complete blood count (CBC) and urine analysis (U/A) completed on 11-JUL-2017 and had the following abnormal results: U/A-trace protein (protein urine present) and ketones (urine ketone body present) 40 (units not provided), BMP-glucose 130 (units not provided) (blood glucose normal) and anion gap 19.6 (units not provided) (anion gap), CBC showed white blood cell count (WBC) 16.0 (units not provided) (white blood cell count increased) and hemoglobin (HGB) 13.6 (units not provided) (haemoglobin normal).   The outcome of the events was unknown. The causality assessment of the events was not reported.  Follow-up information has been received on 15-APR-2019 from FDA (Agency # 703440). The patient's demographics were updated. The date of the vaccination was updated to 10-JUL-2017 at 08:35. The onset date was updated to 11-JUL-2017 at 19:54. The information about the facility where the vaccination was given were updated. The patient had no adverse event following any previous vaccinations.  Follow up information has been received on 23-MAY-2019 from health care professional. The reporter reported that she did not have an 11 year old patient vaccinated on 15-APR-2018. The caller stated she would research and call back if she was able to find any further information.
Age: 22.0
Sex: F
Vaccine: HPV9
Symptoms: Asthenia, Balance disorder, Blood thyroid stimulating hormone normal, Dizziness, Full blood count
Clinical narrative: Asthenia; BALANCE DISORDER; DIZZINES; INJECTION SITE SWELLING; This report was identified from a line listing obtained on request by the Company from the FDA under the Freedom of Information Act. The patient's current conditions included suspected viral gastroenteritis; historical conditions included migraines and stomach issues. None other medications were reported. Prior vaccinations were not reported.  On 05-FEB-2018, shortly after getting the 1st HPV rL1 6 11 16 18 31 33 45 52 58 VLP vaccine (yeast) (GARDASIL 9) vaccine, the patient began to feel dizzy and weak. On 14-FEB-2018 (reported as at day 9), she was still feeling that way. She had obvious loss of balance and was very dizzy. On 13-FEB-2018 (reported as at day 8), she also started to develop swelling at the injection site which had continued. No redness or evidence of infection presented. Lab data was performed on an unknown date in Feburary 2018, complete blood count(CBC) no anemia, but elevated red blood cells (RBC) that were hypochromic and rnicrocytic; Tyroid-stimulating hormone(TSH) normal; Comprehensive Metabolic Panel(CMP) normal.  Follow up information was received from the FDA(HA#737572) under the Freedom of Information Act on 15-APR-2019 refers to patient. The report was received from a family nurse practitioner (FNP).  Follow up information has been received from the nurse on 23-MAY-2019. The reporter was unable to identify the patient in this report. Date of vaccination was provided to assist in obtaining patient information. The reporter would follow up upon obtaining additional information.
Age: 22.0
Sex: F
Vaccine: HPV9
Symptoms: Injection site swelling, Metabolic function test normal, Red blood cell count increased
Clinical narrative: Asthenia; BALANCE DISORDER; DIZZINES; INJECTION SITE SWELLING; This report was identified from a line listing obtained on request by the Company from the FDA under the Freedom of Information Act. The patient's current conditions included suspected viral gastroenteritis; historical conditions included migraines and stomach issues. None other medications were reported. Prior vaccinations were not reported.  On 05-FEB-2018, shortly after getting the 1st HPV rL1 6 11 16 18 31 33 45 52 58 VLP vaccine (yeast) (GARDASIL 9) vaccine, the patient began to feel dizzy and weak. On 14-FEB-2018 (reported as at day 9), she was still feeling that way. She had obvious loss of balance and was very dizzy. On 13-FEB-2018 (reported as at day 8), she also started to develop swelling at the injection site which had continued. No redness or evidence of infection presented. Lab data was performed on an unknown date in Feburary 2018, complete blood count(CBC) no anemia, but elevated red blood cells (RBC) that were hypochromic and rnicrocytic; Tyroid-stimulating hormone(TSH) normal; Comprehensive Metabolic Panel(CMP) normal.  Follow up information was received from the FDA(HA#737572) under the Freedom of Information Act on 15-APR-2019 refers to patient. The report was received from a family nurse practitioner (FNP).  Follow up information has been received from the nurse on 23-MAY-2019. The reporter was unable to identify the patient in this report. Date of vaccination was provided to assist in obtaining patient information. The reporter would follow up upon obtaining additional information.
Age: 65.0
Sex: F
Vaccine: VARZOS, VARZOS
Symptoms: Fatigue, Immediate post-injection reaction, Influenza like illness, Pain, Pain in extremity
Clinical narrative: fever; sore arm; flu like symptoms; This case was reported by a consumer via call center representative and described the occurrence of fever in a 65-year-old female patient who received Herpes zoster (Shingrix) (batch number 4G5HX, expiry date unknown) for prophylaxis.   Previously administered products included Zostavax. Concurrent medical conditions included allergy to antibiotic (Sulfa antibiotics), drug hypersensitivity (to neomycin) and iodine allergy.   On 14th March 2019, the patient received the 1st dose of Shingrix. On 14th March 2019, several hours after receiving Shingrix, the patient experienced fever, injection site pain and influenza-like symptoms. On an unknown date, the outcome of the fever, injection site pain and influenza-like symptoms were recovered/resolved.   It was unknown if the reporter considered the fever, injection site pain and influenza-like symptoms to be related to Shingrix.  Additional details were reported as follows: The reporter was the patient. The patient received the Shingrix on left arm. The patient developed soreness in the left arm immediately after receiving the vaccine.  The patient stated that the soreness continued for 5 days.  The patient stated that a couple of hours after receiving the Shingrix vaccine, she developed a fever of 101.2 degree F, and flu like symptoms.  These symptoms resolved 2 to 3 days later.  Please note that the lot information provided for the Shingrix dose was confirmed with the caller. The reported batch number 465HX for Shingrix did not exist and was updated to 4G5HX as per the sales database.  The patient experienced a sore arm after receiving a Tetanus vaccine (unknown manufacturer). This case has been linked with US2019GSK091815, reported by same reporter.
Age: 65.0
Sex: F
Vaccine: VARZOS, VARZOS
Symptoms: Pyrexia
Clinical narrative: fever; sore arm; flu like symptoms; This case was reported by a consumer via call center representative and described the occurrence of fever in a 65-year-old female patient who received Herpes zoster (Shingrix) (batch number 4G5HX, expiry date unknown) for prophylaxis.   Previously administered products included Zostavax. Concurrent medical conditions included allergy to antibiotic (Sulfa antibiotics), drug hypersensitivity (to neomycin) and iodine allergy.   On 14th March 2019, the patient received the 1st dose of Shingrix. On 14th March 2019, several hours after receiving Shingrix, the patient experienced fever, injection site pain and influenza-like symptoms. On an unknown date, the outcome of the fever, injection site pain and influenza-like symptoms were recovered/resolved.   It was unknown if the reporter considered the fever, injection site pain and influenza-like symptoms to be related to Shingrix.  Additional details were reported as follows: The reporter was the patient. The patient received the Shingrix on left arm. The patient developed soreness in the left arm immediately after receiving the vaccine.  The patient stated that the soreness continued for 5 days.  The patient stated that a couple of hours after receiving the Shingrix vaccine, she developed a fever of 101.2 degree F, and flu like symptoms.  These symptoms resolved 2 to 3 days later.  Please note that the lot information provided for the Shingrix dose was confirmed with the caller. The reported batch number 465HX for Shingrix did not exist and was updated to 4G5HX as per the sales database.  The patient experienced a sore arm after receiving a Tetanus vaccine (unknown manufacturer). This case has been linked with US2019GSK091815, reported by same reporter.
Age: 65.0
Sex: F
Vaccine: VARZOS, VARZOS
Symptoms: Immediate post-injection reaction, Influenza like illness, Injection site pain, Pyrexia
Clinical narrative: fever; sore arm; flu like symptoms; This case was reported by a consumer via call center representative and described the occurrence of fever in a 65-year-old female patient who received Herpes zoster (Shingrix) (batch number 4G5HX, expiry date unknown) for prophylaxis.   Previously administered products included Zostavax. Concurrent medical conditions included allergy to antibiotic (Sulfa antibiotics), drug hypersensitivity (to neomycin) and iodine allergy.   On 14th March 2019, the patient received the 1st dose of Shingrix. On 14th March 2019, several hours after receiving Shingrix, the patient experienced fever, injection site pain and influenza-like symptoms. On an unknown date, the outcome of the fever, injection site pain and influenza-like symptoms were recovered/resolved.   It was unknown if the reporter considered the fever, injection site pain and influenza-like symptoms to be related to Shingrix.  Additional details were reported as follows: The reporter was the patient. The patient received the Shingrix on left arm. The patient developed soreness in the left arm immediately after receiving the vaccine.  The patient stated that the soreness continued for 5 days.  The patient stated that a couple of hours after receiving the Shingrix vaccine, she developed a fever of 101.2 degree F, and flu like symptoms.  These symptoms resolved 2 to 3 days later.  Please note that the lot information provided for the Shingrix dose was confirmed with the caller. The reported batch number 465HX for Shingrix did not exist and was updated to 4G5HX as per the sales database.  The patient experienced a sore arm after receiving a Tetanus vaccine (unknown manufacturer). This case has been linked with US2019GSK091815, reported by same reporter.
Age: 47.0
Sex: M
Vaccine: PPV
Symptoms: Fatigue, Myalgia, Pyrexia, Vaccination site pain, White blood cell count increased
Clinical narrative: fever, myalgias, fatigue, vaccine site tenderness
Age: 11.0
Sex: M
Vaccine: JEV1
Symptoms: Rash, Rash erythematous, Rash maculo-papular
Clinical narrative: erythematous maculopapular eruption on bilateral cheeks, extensor arms and legs and lower back
Sex: M
Vaccine: MMR
Symptoms: Headache, Muscle twitching, Pain in extremity
Clinical narrative: He complained of "twitching" feeling; He complained of soreness for a day in his right arm (dominate arm); He complained of headache; This spontaneous report was received from the patient's wife, refering to her husband, a 28 year old male patient. The patient had not any pertinent medical history, concurrent condition, drug reaction/allergy and was not taking any concomitant medication.      On 01-MAY-2019, the patient was vaccinated with the first dose of measles, mumps, and rubella (wistar ra 27-3) virus vaccine, live (M-M-R II) for catch up on immunization due to the recent measles outbreaks locally and worked outside in the heat. On this same vaccination date, the patient then, complained of a headache, twitching feeling (muscle twitching) and soreness for a day in his right arm (dominate arm) (pain in extremity). He did not take anything for the headache, soreness or the twitching feeling. No laboratory studies were performed neither medical attention was sought.  By the next day, on 02-MAY-2019, the symptoms had resolved.   The causality assessment was not provided.
Sex: M
Vaccine: HEPA
Symptoms: Wrong product administered
Clinical narrative: A 2 week old male patient was given Vaqta hepatitis A instead of hepatitis B vaccine on 06May2019; A 2 week old male patient was given Vaqta hepatitis A instead of hepatitis B vaccine on 06May2019; This spontaneous report was received from a medical assistant, referring  to a 2 week old male patient. The patient's medical history, concurrent conditions, concomitant therapies and drug or allergy reactions were not provided.  On 06-MAY-2019, the patient was vaccinated with hepatitis a vaccine, inactivated (VAQTA) (strength, dose, dose number and administration route were not reported) lot number S002459 and expiration date  on 15-MAY-2020, for prophylaxis; instead of hepatitis b vaccine (recombinant) (manufacturer unknown).
Sex: M
Vaccine: MMR
Symptoms: Chemotherapy
Clinical narrative: chemotherapy; This spontaneous report has been received from a male patient (consumer) of unknown age referring to himself. Information about medical history, concurrent conditions and concomitant therapies was not provided.      On an unknown date, the patient was vaccinated with Measles, Mumps, and Rubella (Wistar RA 27-3) Virus Vaccine, Live (M-M-R II) injection (strength, dose, frequency, route, lot number and expiration date were not reported) for prophylaxis.        After vaccinated with Measles, Mumps, and Rubella (Wistar RA 27-3) Virus Vaccine, Live (M-M-R II), the patient in life had had "chemotherapy" and wanted to know if it was safe to be revaccinated on the advice of his doctor. He declined to participate in the adverse event report and declined to provide full demographics. The outcome of the event was not reported.        The causality between the event and Measles, Mumps, and Rubella (Wistar RA 27-3) Virus Vaccine, Live (M-M-R II) was not provided.
Sex: U
Vaccine: MMR
Symptoms: Expired product administered, No adverse event
Clinical narrative: The medical assistant reported that one dose of expired MMR II was administered to the patient.; No adverse effects were reported.; This spontaneous report was received from a medical assistant referring to a patient of unknown age and gender. The patient's medical history, concurrent conditions, concomitant medications, and historical drugs were not reported.  On 17-MAY-2019, the patient was vaccinated with an expired dose of measles, mumps, and rubella (wistar ra 27-3) virus vaccine, live(M-M-R II) 1 dose (strength, route, dose, frequency, and anatomical location were unknown) with  lot # N014486 and expiration date 10-MAY-2019 for prophylaxis reconstituted with a sterile diluent. No adverse effects were reported.
Age: 44.0
Sex: F
Vaccine: HPV9
Symptoms: Injection site inflammation, Injection site pain, Injection site swelling
Clinical narrative: the patient developed swelling, inflammation, and pain at the injection site"; the patient developed swelling, inflammation, and pain at the injection site"; the patient developed swelling, inflammation, and pain at the injection site"; This spontaneous report was received from registered nurse via company representative refers to a 44 year old female patient. Information on patient's historical condition, concurrent condition and concomitant medication was not provided.  On 14-MAY-2019 (also reported as "6 days ago") the patient was vaccinated with hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast)(GARDASIL 9) (dose details, route of administration, lot, batch and expiration date were not reported) for prophylaxis.  In May 2019 (also reported as on an unspecified date, after the vaccination) the patient experienced swelling, inflammation and pain at the injection site (vaccination site swelling, vaccination site inflammation and vaccination site pain). At the time of report the outcome of vaccination site pain, vaccination site inflammation and vaccination site swelling was unknown. The causality of the events vaccination site pain, vaccination site inflammation and vaccination site swelling with respect to the suspect therapy hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast)(GARDASIL 9) was not provided. No product quality complaint involved.
Sex: U
Vaccine: HEPA
Symptoms: Expired product administered, No adverse event
Clinical narrative: No adverse effect were reported; patient was inadvertently administered an expired dose of VAQTA; This spontaneous report was received from a medical assistant referring to a patient of unknown age and gender. The patient's pertinent medical history, concurrent conditions, drug reactions/allergies and concomitant medications were not provided.     On 21-MAY-2019, the patient was vaccinated inadvertently with an expired dose of hepatitis a vaccine, inactivated (VAQTA) lot # R009952, expiry date on 17-MAR-2019, by intramuscular route, for prophylaxis. No adverse effects were reported.
Age: 0.75
Sex: F
Vaccine: RV5
Symptoms: Product storage error
Clinical narrative: Patient received improperly stored dose of ROTATEQ; This spontaneous report was received from a registered nurse concerning a 9 month old female patient. In 2018, the patient was vaccinated with 2 unspecified vaccines and had seizures for which, she was hospitalized on 11-MAY-2019 and discharged on the same date (# 1905USA010626). The patient's concurrent conditions was unknown and the patient had no concomitant medications.  On 11-MAY-2019, the patient was vaccinated with an improperly stored dose of rotavirus vaccine, live, oral, pentavalent (ROTATEQ) (strength, dose and frequency were unknown) (lot # R017926, expiration date 30-APR-2020) orally for prophylaxis. The reporter stated that the vaccine had a temperature excursion of a highest temperature of above 47F/9C (56F) for 43 minutes and it was detected by a data logger. The vaccine had no previous temperature excursions.  This is one of two reports for the same patient.; Sender's Comments:  US-009507513-1905USA010626:
Sex: F
Vaccine: HPV9
Symptoms: Adverse event
Clinical narrative: adverse event; First dose was in february 2018, the patient had not had her second dose; This spontaneous report was received from a physician via a company representative and concerns to a 12-year-old female patient. The patient's concurrent conditions and medical history, as well as concomitant medications, were not reported.  In February 2018, the patient was vaccinated with the first dose of hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast) (GARDASIL 9) (strength, dose, route, anatomical site, lot# and expiration date were unknown) for prophylaxis.  On an unknown date, the patient experienced an unspecified adverse event. The reporter also stated that the patient had not had her second dose of and inappropriate schedule of hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast) (GARDASIL 9).  At the reporting time, the outcome of the unspecified adverse event was reported as recovered on an unknown date.  The causality between hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast) (GARDASIL 9) and the unspecified adverse event was not reported.  The reporter stated that the unspecified adverse event was not life-threatening.
Sex: F
Vaccine: MMR
Symptoms: Hypoaesthesia, Pain in extremity, Paraesthesia
Clinical narrative: The patient experienced tingling and numbness in her fingers; The patient experienced severe pain in the arm; The patient experienced tingling and numbness in her fingers; This spontaneous report as received from a patient's husband refers to a 61 year old female patient. The patient's concurrent conditions, pertinent medical history and concomitant therapy were not reported.  On an unknown date, the patient was vaccinated with a dose of measles, mumps, and rubella (wistar ra 27-3) virus vaccine, live(M-M-R II) (dose, lot#, expiration date, route and albumin status were not reported)  for prophylaxis.         On an unknown date, after receiving the vaccine, the patient experienced severe pain in the arm (pain in extremity ), tingling (paraesthesia) and numbness (hypoaesthesia) in her fingers.The patient visited the physician and was prescribed an unspecified steroid to treat the pain and numbness.  At the time of the report, the outcome of hypoaesthesia, paraesthesia and pain in extremity was reported as not resolved.        The relationship between hypoaesthesia, paraesthesia, pain in extremity and measles, mumps, and rubella (wistar ra 27-3) virus vaccine, live(M-M-R II) was not reported.
Sex: F
Vaccine: HPV9
Symptoms: Injection site pruritus
Clinical narrative: itching at the injection site; This spontaneous report was received from a physician refers to a female patient who is currently 18 years old. The patient's medical history, concurrent conditions and concomitant medications were unknown. On 04-SEP-2018, the patient was vaccinated with first dose, of hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast) (GARDASIL 9) (dose, frequency, route of administration, lot# and expiry unknown) for prophylaxis. Patient was vaccinated with second dose of hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast) (GARDASIL 9) (dose, frequency, route of administration, lot# and expiry unknown) for prophylaxis on 13-NOV-2018. On an unknown date, after the second dose of vaccination, patient experienced itching at the injection site (injection site pruritus). No treatment was given for the event. The outcome of injection site pruritus was unknown. Causality assessment was unknown. Product quality complaints was not involved. The physician reported that, he noticed this adverse event when patient came for office visit at the end of April 2019.
Age: 17.0
Sex: U
Vaccine: HEPA
Symptoms: Incorrect dose administered, No adverse event
Clinical narrative: 17 year old patient was administered an adult dose of VAQTA; NO ADVERSE EFFECT; This spontaneous report as received from an office manager refers to a 17-year-old patient.  Information on patient's medical history, concurrent condition and previous drug reactions and  concomitant therapies was not provided.     On 31-JUL-2018, an unspecified patient "17-year-old"was vaccinated with adult dose of hepatitis a vaccine, inactivated (VAQTA) lot # R002487) for prophylaxis (incorrect dose administered).  No adverse affects were reported. No additional information at the time of report. No product quality compliant (PQC).  The outcome of incorrect dose administered and no adverse event  was unknown.
Sex: M
Vaccine: HPV9
Symptoms: Inappropriate schedule of product administration, No adverse event
Clinical narrative: altered dosing schedule; No adverse effect; This spontaneous report was received from a pharmacist referred to a 20-year-old male patient.  Information regarding medical history, concurrent condition and concomitant medications were not reported. On 25-JUL-2017, the patient was vaccinated with first dose of hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast) (GARDASIL 9) injection with lot # M037770 (Lot No. M037770 has been verified to be a valid lot number for hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast), expiration date not reported, but upon internal validation established as 01-JUN-2019) for prophyaxis (dose and route were not reported). It was reported that, the patient received altered dosing schedule for hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast) (GARDASIL 9) injection as he received the second dose on an unknown date, late in November 2018 (dose, route, lot # and expiry date were not reported) (Inappropriate schedule of product administration). No adverse effects were reported (no adverse event). Product quality complaint was not involved.
Sex: U
Vaccine: HEP
Symptoms: Expired product administered, No adverse event
Clinical narrative: Patient received expired dose of HEPLISAV-B; Initial Report Received on 13-May-2019, 14-May-2019, and 15-May-2019  An inventory specialist and a pharmacist both separately reported that a patient (age, gender and race not provided) was administered with HEPLISAV-B (hepatitis B vaccine) for hepatitis B immunization that was an expired dose.  Relevant medical history and concomitant medications were not provided.  On 13-May-2019, an inventory specialist reported that he received a phone call from a pharmacist, who was also the pharmacy store manager, who reported that an expired vial of HEPLISAV-B was sent to the pharmacist's store, and the vaccine was given to a patient on this date, two days after the expiration date (lot # 1033385, expiration date 11 May 2019). He reported that the patient's age, gender, and medical history/allergies were unknown, the provider's information was unknown, that it was unknown if adverse events were experienced, and that he would follow-up with the pharmacist for additional information.    On 14-May-2019, the inventory specialist reported that he would have the pharmacist contact Dynavax.  On 15-May-2019, the pharmacist from an outpatient pharmacy contacted Dynavax and confirmed that the patient received the expired HEPLISAV-B dose on 13-May-2019, confirmed that the dose was administered from a vial and provided the same lot # and expiration date as the inventory specialist, and reported that the patient did not experience any adverse events. The pharmacist refused to provide the patient's initials, date of birth, gender, or contact information. No other information was provided.  At the time of the report, the outcome of the event was unknown.  The reporter did not provide a seriousness assessment for the event.   Company comment: The company assessed the event of expired product administered as non-serious. The event of expired product administered is unlisted per HEPLISAV-B USPI.; Sender's Comments: The company assessed the event of expired product administered as non-serious. The event of expired product administered is unlisted per HEPLISAV-B USPI.
Sex: U
Vaccine: HEP
Symptoms: Expired product administered
Clinical narrative: Expired dose of Heplisav-B administered to patient; Initial Report Received on 15-May-2019 and 21-May-2019  A practice manager from a healthcare practice reported that a female patient (age and race not provided) was administered with HEPLISAV-B (hepatitis B vaccine) for hepatitis B immunization that was an expired dose.   The patient had no relevant medical history or allergies. Concomitant medications were not provided.  On 15-May-2019, a medical assistant administered the patient with an expired dose of HEPLISAV-B (lot #1032912, expiration date 20-Mar-2019). The practice manager stated that she would call back after determining what further information she could provide about the incident. No further information was provided.    At the time of the report, the outcome of the event was unknown.  The reporter did not provide a seriousness assessment for the event.   Company comment:  The company assessed the event of expired product administered as non-serious. The event of expired product administered is unlisted per HEPLISAV-B USPI.; Sender's Comments: The company assessed the event of expired product administered as non-serious. The event of expired product administered is unlisted per HEPLISAV-B USPI.
Sex: U
Vaccine: VARZOS
Symptoms: Myalgia, Pain in extremity
Clinical narrative: Sore arm; Muscle pain; This case was reported by a consumer via call center representative and described the occurrence of pain in arm in a adult patient who received Herpes zoster (Shingrix) for prophylaxis.   On an unknown date, the patient received Shingrix at an unknown dose. On an unknown date, unknown after receiving Shingrix, the patient experienced pain in arm and muscle pain. On an unknown date, the outcome of the pain in arm and muscle pain were unknown.   It was unknown if the reporter considered the pain in arm and muscle pain to be related to Shingrix.  Additional details were provided as follows: This case was reported by the consumer for one of the receptionist at the outpatient clinic. The age at vaccination was not reported. The patient had sore arms and muscle pain with the vaccine. He did not have the patient identifiers. Caller did not provide his doctor's address on the phone. This case has been linked with case US2019087036, US2019AMR088911, and US2019AMR088873 reported by the same reporter
Sex: U
Vaccine: VARZOS
Symptoms: Myalgia, Pain in extremity
Clinical narrative: Sore arm; Muscle pain; This case was reported by a consumer via call center representative and described the occurrence of pain in arm in a adult patient who received Herpes zoster (Shingrix) for prophylaxis.   On an unknown date, the patient received Shingrix at an unknown dose. On an unknown date, unknown after receiving Shingrix, the patient experienced pain in arm and muscle pain. On an unknown date, the outcome of the pain in arm and muscle pain were unknown.   It was unknown if the reporter considered the pain in arm and muscle pain to be related to Shingrix.  Additional details were provided as follows: This case was reported by the consumer for one of the receptionist at the outpatient clinic. The age at vaccination was not reported. The patient had sore arms and muscle pain with the vaccine. He did not have the patient identifiers. Caller did not provide his doctor's address on the phone. This case has been linked with case US2019087036, US2019AMR088911, and US2019AMR088873 reported by the same reporter.
Age: 67.0
Sex: F
Vaccine: VARZOS, VARZOS
Symptoms: Injection site pain
Clinical narrative: soreness at the injection site; This case was reported by a physician via call center representative and described the occurrence of injection site pain in a 67-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   On 30th January 2018, the patient received the 1st dose of Shingrix. On an unknown date, the dose was an unknown dose. On an unknown date, unknown after receiving Shingrix, the patient experienced injection site pain. On an unknown date, the outcome of the injection site pain was recovered/resolved.   It was unknown if the reporter considered the injection site pain to be related to Shingrix.  Additional details were provided as follows: This case was reported by the physician for his wife. The patient received the 1st dose of the Shingrix and only experienced soreness at the injection site. At the time of this call the representative was unable to obtain additional information, because the call was disconnected. Hence the representative called back and left message. The physician did not give consent to follow up. This case has been linked to the US2019087006, reported for the dose 2 of the same patient by the same reporter.
Age: 19.0
Sex: F
Vaccine: MENB
Symptoms: Injection site induration, Injection site mass, Injection site pain
Clinical narrative: Enduration hard knot; Pain / pain under the skin at the site of injection; Injection site knot; This case was reported by a nurse via call center representative and described the occurrence of injection site induration in a 19-year-old female patient who received Men B NVS (Bexsero) (batch number ABX747AA, expiry date 29th February 2020) for prophylaxis.   On 23rd April 2019, the patient received Bexsero (intramuscular) .5 ml. On 23rd April 2019, less than a day after receiving Bexsero, the patient experienced injection site induration, injection site pain and injection site lump. On an unknown date, the outcome of the injection site induration, injection site pain and injection site lump were not recovered/not resolved.   It was unknown if the reporter considered the injection site induration, injection site pain and injection site lump to be related to Bexsero.  Additional case details were reported as follows: The patient received vaccine on right arm. On the day of vaccination, patient experienced enduration hard knot and pain under the skin at the site of injection.  At the time of reporting, the patient still experiencing it. This case had been linked to the case US2019086320, reported by same reporter.