chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Sex: F
Vaccine: VARZOS
Symptoms: Injection site swelling, Lip discolouration, Lip pain
Clinical narrative: This spontaneous was received from a 60-year-old female company representative, referring to herself. The patient had no medical history, concomitant medications nor concurrent conditions. On 18-MAY-2017, the patient was vaccinated with a dose of ZOSTAVAX (dose, frequency, route of administration, lot number and expiration date were not provided) reconstituted with sterile diluent (MERCK STERILE DILUENT) (dose, lot number and expiration date were not reported). On 20-MAY-2017, the patient experienced injection site reaction, which was swollen, red, itchy, painful and was about 5-7 cm in diameter. On the same day, the patient also noticed "something that looked like shingles" on the inside portion of her lip, extending to the outer portion of her lip and being red and painful. Moreover, there was a bubble on the inside of her lip which was filled with liquid. The patient did not seek for any medical attention, but stated that she would if the symptoms got worse. No treatment was given for the events at the time of the report.  The patient recovered fully from the injection site reaction on approximately 27-MAY-2017 (reported as "in about a week"). The patient did not recover from "something that looked like shingles" on the patient's lip and the "bubble filled with liquid" at the reporting time (reported as the symptoms on her lip were not getting any better, nor any worse at the time of the report). The relatedness between the events and the suspect therapy was not reported. Additional information is not expected as there was no consent for further contact.
Age: 75.0
Sex: F
Vaccine: VARZOS
Symptoms: Exposure via skin contact, No adverse event, Underdose
Clinical narrative: This spontaneous report was received from a pharmacist and refers to a patient of unknown age and gender. The patient's pertinent medical history, concomitant medications and drug reactions or allergies were not reported. On an unspecified date, the patient received a partial dose of ZOSTAVAX (19400 plaque-forming units, PFU) (injection, for prophylaxis, lot # M042851 with expiration date at 28-JAN-2018; dose, route of administration and anatomical location were not reported) reconstituted with stored sterile diluent (STERILE DILUENT) (strength, dose, lot # and expiration date were not reported). On the same date, the patient experienced a skin exposure to ZOSTAVAX reconstituted with stored sterile diluent (STERILE DILUENT). No adverse effects were reported. No product quality complaint (PQC) was involved. Additional information has been requested.
Sex: U
Vaccine: PPV
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report was received from a registered nurse and refers to an unknown number of patients of unknown age and gender. The patient's concomitant medications, pertinent medical history and drug reactions or allergies were not reported. On unknown dates, the patients were vaccinated with improperly stored doses of PNEUMOVAX 23 injection, lot # M020521 with expiry date 17-NOV-2017 (exact dose and route of administration were not reported). The doses were exposed to the temperature of 46.8 degrees Fahrenheit for 13 hours. Previous temperature excursions included 48.2 degrees Fahrenheit for 13 hours. Digital data logger was involved. No adverse effects were reported. This is one of two reports received from the same reporter. Additional information has been requested.; Sender's Comments:  US-009507513-1706USA010705:
Sex: U
Vaccine: HPV9
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report was received from a medical assistant and refers to an unspecified number of patients of unknown age and gender. No information about the patients' pertinent medical history, concomitant medications and drug reactions or allergies was reported. On unspecified dates, the patients were vaccinated with improperly stored doses of GARDASIL 9 injection, lot # M030380 with the expiration date of 01-FEB-2019 and lot # N002720 with the expiration date of 12-MAY-2019 (dose, route and site of administration were not reported), for prophylaxis. The administered doses of GARDASIL 9 underwent a temperature excursion between 9 and 25 Celsius degrees (average 10.8 Celsius degrees) for 20 minutes. Digital Data Logger was involved. No adverse events were reported. This is one of several reports received from the same source. Additional information has been requested. Sender's Comments: US-009507513-1705USA005160.
Sex: U
Vaccine: RV5
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report was received from a medical assistant and refers to an unspecified number of patients of unknown age and gender. No information about the patients' pertinent medical history, concomitant medications and drug reactions or allergies was reported. On unspecified dates, the patients were vaccinated with improperly stored doses of ROTATEQ, orally, lot # M040271 with the expiration date of 30-APR-2018, for prophylaxis. The administered doses of ROTATEQ underwent a temperature excursion between 9 and 25 Celsius degrees (average 10.8 Celsius degrees) for 20 minutes. Digital Data Logger was involved. No adverse events were reported. This is one of several reports received from the same source. Additional information has been requested.; Sender's Comments:  US-00957513-1705USA005160:
Sex: U
Vaccine: HIBV
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report was received from a medical assistant referring to an unspecified number of patients of unspecified demographics. Information regarding the patients' pertinent medical history, drug reactions or allergies and concomitant therapies was not provided. On unknown dates, the unspecified number of improperly stored doses of LIQUID PEDVAXHIB lot # N000235 with an expiration date of 26-OCT-2019, or lot# N000237 with an expiration date of 25-OCT-2019 (dose, route of administration and anatomical location were not reported) were inadvertently administered to the patients. No adverse effects were reported. The vaccines were exposed to temperature of 47 degrees Fahrenheit for 30 minutes before administration to the patients. There was a previous temperature excursion reported, with a temperature of 56 degrees Fahrenheit for 5 hours. The digital data logger was involved. The product quality complaint was not involved. This is one of several reports received from the same reporter. Additional information is not expected, as there was no consent for further contact.; Sender's Comments: US-009507513-1706USA009734: US-009507513-1706USA004159:
Sex: U
Vaccine: VARCEL
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report was received from a medical assistant referring to an unspecified number of patients of unspecified demographics. Information regarding the patients' pertinent medical history, drug reactions or allergies and concomitant therapies was not provided. On unknown dates, the unspecified number of improperly stored doses of VARIVAX lot # M046005 with an expiration date of 05-NOV-2018 (also reported as 18-NOV-2018) (dose, route of administration and anatomical location were not reported) reconstituted with properly stored sterile diluent (manufacturer unknown) were inadvertently administered to the patients. No adverse effects were reported. The vaccines were exposed to a temperature of 6 degrees Fahrenheit for 5 hours (supported) before administration to the patients. There was no previous temperature excursion reported. The digital data logger was involved. The product quality complaint was not involved. This is one of several reports received from the same reporter. Additional information is not expected, as there was no consent for further contact.; Sender's Comments: US-009507513-1706USA004159: US-009507513-1706USA009733:
Age: 12.0
Sex: M
Vaccine: HPV9, MNQ
Symptoms: Inappropriate schedule of drug administration, No adverse event
Clinical narrative: This spontaneous report was received from a medical assistant concerning a 12 year old male patient. The patient's concurrent conditions, medical history, historical drugs and concomitant therapies were not reported.  On 30-MAY-2017, the patient received the first dose of GARDASIL 9 (dose, route, lot number and expiration date were not reported), and on 21-JUN-2017, the patient received the second dose of GARDASIL 9 lot number M041990, expiration date 28-JUN-2019 (dose and route were not reported) both for prophylaxis. Both vaccines were administered too close together. No adverse effects were reported. Additional information has been requested.
Sex: U
Vaccine: HEP
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report was received from a registered nurse and refers to an unknown number of patients of unknown age and gender. The patient's concomitant medications, pertinent medical history and drug reactions or allergies were not reported. On unknown dates, the patients were vaccinated with improperly stored doses of RECOMBIVAX HB, lot # M000442 with expiry date 31-MAR-2018 (exact dose and route of administration were not reported). The doses were exposed to the temperature of 46.8 degrees Fahrenheit for 13 hours. Previous temperature excursions included 48.2 degrees Fahrenheit for 13 hours. Digital data logger was involved. No adverse effects were reported. This is one of two reports received from the same reporter.  Additional information has been requested.
Age: 25.0
Sex: F
Vaccine: HPV9
Symptoms: Exposure during pregnancy
Clinical narrative: This spontaneous prospective pregnancy report as received from a nurse refers to a 25 year old female patient. The patient had an allergy to nickel, with allergy to metals. The patient's pertinent medical history included type one Herpes simplex virus (reported as "type one HSB"). On 08-MAR-2017, the patient was vaccinated with a dose of GARDASIL 9 intramuscularly (lot # M032650, expiry date 31-FEB-2019, dose not provided) when she was 3 weeks pregnant. Concomitant medications included unspecified pre-natal vitamins. Last menstrual period was calculated to 15-FEB-2017, estimated conception date was 01-MAR-2017 and estimated delivery date was 22-NOV-2017. The pregnancy outcome was pending and fetal outcome was unknown. Exposure to GARDASIL 9 occurred in the patient's first trimester. Additional information has been requested.
Sex: U
Vaccine: MMR, VARCEL
Symptoms: Inappropriate schedule of drug administration, No adverse event
Clinical narrative: This spontaneous report was received from a physician's assistant and refers to a patient of unknown age and gender. No information regarding the patient's concurrent conditions, medical history and concomitant therapies was reported. On 01-AUG-2016, the patient received a dose of M-M-R II (dose, route of administration, lot# and expiration date were not reported)for prophylaxis. On 05-AUG-2016, the patient received a dose of VARIVAX (dose, route of administration, lot# and expiration date were not reported)for prophylaxis. The vaccines were reconstituted with sterile diluent (manufacturer unknown) (lot# and expiration date were not reported). No adverse effects were reported. Additional information has been requested.
Age: 62.0
Sex: M
Vaccine: VARZOS
Symptoms: Rash, Rash pruritic
Clinical narrative: This spontaneous report was received from a 62-year-old male physician who was reporting on himself. There was no information about the patient concurrent conditions and medical history provided. The patient did not have any known drug reactions or allergies.  On approximately 16-MAY-2017, also reported as "3 weeks ago", the patient was vaccinated with ZOSTAVAX, subcutaneously for Herpes Zoster prevention (anatomical location, lot# and expiration date were not reported). On the same day, the the patient had also administered sterile diluent (STERILE DILUENT) subcutaneously for the same indication (dose, anatomical location, lot# and expiration date were not reported). On approximately 17-MAY-2017, also reported as "a day after", the patient had a rash on his whole left arm, which was raised and itchy. The patient did not seek medical attention and and on an unknown date he applied an unspecified strength and dose of hydrocortisone (manufacturer unknown) to treat the rash. At the reporting time, the patient's rash was improved, except for the rash under his arm, which still persisted. The patient declined offer of varicella zoster virus identification program (VZVIP) packet. The outcome of the events was reported as recovering. The relatedness between the events and ZOSTAVAX was not reported. Additional information has been requested.
Age: 11.0
Sex: F
Vaccine: HPV9
Symptoms: Immediate post-injection reaction, Vision blurred
Clinical narrative: This spontaneous report as received from a Medical Assistant via a company representative, concerning an 11 year old female patient. The patient's concurrent conditions included migraines and other unspecified medical history. Information regarding drug reactions/allergies were unknown by the reporter. On 05-JUN-2017, the patient was vaccinated with a dose of GARDASIL 9 lot # M043731 and expiration date of 22-JUN-2019, intramuscularly for prophylaxis as part of a vaccine for children program ("VFC") (dose was not reported). On the same date, immediately after receiving GARDASIL 9, in the Health Care Professional's (HCP's) office the patient experienced blurry vision. There was no treatment given for the adverse event and none laboratories were performed. At the time of reporting the patient did not recover from vision blurred. The causal relationship between the event and therapy with GARDASIL 9 was not reported. Additional information has been requested.
Sex: U
Vaccine: HEPA
Symptoms: Expired product administered, No adverse event
Clinical narrative: This spontaneous report was received from an office manager refers to a patient of unknown age and unknown gender. The patient's medical history, concurrent conditions and concomitant therapies were not reported. On 08-JUN-2017, the patient was vaccinated with one expired dose of VAQTA, (25 units/0.5 ml) injection, route of administration was not reported, (lot # K019560 and date of expiration: 02-JUN-2017). No adverse effects were reported. Additional information has been requested.
Sex: U
Vaccine: MMR
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: Information has been received from a nurse practitioner concerning 2 patients of unknown age and gender. The patients medical history, concurrent conditions, concomitant medications and drug reactions/allergies were not provided. On 09-JUN-2017, the patients were vaccinated with M-M-R II (lot #: M048368 with expiration date: 08-DEC-2018) (dose, strength, frequency, route of administration and anatomical location were not reported), for prophylaxis. The administered vaccines were improperly stored at temperature greater than 47°F but less than 77°F for 13 hours without any previous temperature excursion; this information was registered in a digital data logger. No adverse effects were reported. Additional information has been requested.
Sex: U
Vaccine: VARCEL
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report was received from a registered nurse and refers to 9 patients of unknown age and gender. The patient's concomitant medications, pertinent medical history and drug reactions or allergies were not reported. On unknown dates, the patients were vaccinated with improperly stored doses of VARIVAX injection, lot # L041204 with expiry date 20-OCT-2017 (exact dose and route of administration were not reported). The doses were exposed to the temperature of -14 degrees Celsius for 15 minutes. Previous temperature excursions included exposure to temperatures between -9 degrees Celsius to 8 degrees Celsius (-3 degrees Celsius) for 6 hours, between -9 degrees Celsius to 8 degrees Celsius (0.8 degrees Celsius) for 45 minutes, between -14 degrees Celsius to -10 degrees Celsius (-13 degrees Celsius) for 1 hour 30 minutes and between -14 degrees Celsius to -10 degrees Celsius (-14 degrees Celsius) for 16 hours 40 minutes. Digital data logger was involved. No adverse effects were reported. Additional information has been requested.
Age: 26.0
Sex: M
Vaccine: HPV9
Symptoms: Inappropriate schedule of drug administration, No adverse event
Clinical narrative: Information was received on 13-JUN-2017 from a male patient of unknown age. No medical history or concomitant medications were reported. The patient reported that he received his first dose of GARDASIL 9 on 21-DEC-2016, his second dose on 07-FEB-2017 and his third dose on 20-APR-2017 (no lot numbers, expiration dates, dose or sites reported) for prophylaxis. The interval between the second and third dose was shorter than recommended. No adverse effects reported. No further information provided. Follow-up information was received on 14-JUN-2017 from the patient. He reported that he received the GARDASIL 9 vaccine injection at the age of 26 which is not indicated according to prescribing information. The patient did not experience any side effects from the injections. No further adverse experience information to report. Additional information is not expected. No permission to contact physician, no additional information to report.
Sex: F
Vaccine: VARZOS
Symptoms: Eyelid oedema, Injection site reaction, Ocular discomfort
Clinical narrative: This spontaneous report was received from a nurse prescriber via a company representative and refers to a female patient of unknown age. The patient had a history of breast cancer. The patient had no concomitant medications and it was unknown if she had any drug reactions or allergies. On 09-JUN-2017, the patient was vaccinated with ZOSTAVAX, subcutaneous injection (dose, frequency, lot# and expiration date were not reported) for prevention of shingles. Other suspect therapy included sterile diluent (lot# and expiration date were not provided). On an unknown day in June 2017, the patient experienced swelling in her left eyelid accompanied with eye pressure and  injection site reaction. She sought medical attention and returned to the office on 13-JUN-2017, where she was prescribed diphenhydramine (BENADRYL) (dose unspecified). There were no lab diagnostics studies performed. The outcome of the events was not reported. The causality between the events and ZOSTAVAX was not reported. Additional information has been requested.
Sex: U
Vaccine: HPV9
Symptoms: Inappropriate schedule of drug administration, No adverse event
Clinical narrative: This spontaneous report was received from a Medical Assistant referring to a patient of unknown age and gender. No information regarding the patient's medical history, concurrent conditions or concomitant therapies was provided. On 26-JAN-2017, the patient was vaccinated with the first dose of GARDASIL 9 (strength, route, lot number and expiration date were not provided) for prophylaxis. On 30-MAR-2017, the patient received the second dose of GARDASIL 9 (strength, route, lot number and expiration date were not provided) for prophylaxis. On an unspecified date the patient received the third dose of GARDASIL 9 lot #: N003703, expiration date on 29-OCT-2019 (strength and route were not provided) for prophylaxis. It was reported that the patient received doses of GARDASIL 9 outside of the prescribing information, however no adverse events reported. Additional information has been requested.
Age: 12.0
Sex: F
Vaccine: HPV9
Symptoms: Seizure, Syncope
Clinical narrative: This spontaneous report was received from an unspecified reporter via a field representative, concerning a 12 years-old female patient. The patient's medical history, concurrent conditions, concomitant medications, drug reactions or allergies were unknown by the reporter. On 19-JUN-2017, the patient was vaccinated with the first dose of GARDASIL 9 (lot #, expiration date, strength, dose and anatomical location were not provided), administered via injection. It was reported that on the same date, the patient experienced convulsions and fainted for an unspecified reason (Seizure/Syncope). She was laid down and she recovered on an unspecified date in June 2017. The patient did not seek medical attention; so no treatment was given for the events and no laboratory diagnostics tests were performed. The relatedness between the seizure and syncope with the GARDASIL 9 was not reported. Upon internal review, the event of seizure was determined to be medically significant. No product quality complaint (PQC) was involved. Additional information has been requested.
Age: 0.5
Sex: U
Vaccine: HEPA
Symptoms: Drug administered to patient of inappropriate age, No adverse event
Clinical narrative: This spontaneous report was received from a registered nurse via a Company representative, referring to a 6 month old patient of unknown gender. The patient's pertinent medical history, concurrent conditions or concomitant medications were not reported. On an unknown date in June 2017 (reported as last week), the patient was vaccinated with VAQTA (lot#, dose, and frequency were unspecified), intramuscularly, for prophylaxis. This vaccine was indicated for persons 12 months of age and older. No adverse event was reported. Additional information has been requested.
Age: 2.0
Sex: U
Vaccine: HPV4
Symptoms: Drug administered to patient of inappropriate age, No adverse event
Clinical narrative: This spontaneous report was received from a medical assistant and refers to a 2 year old patient of unknown gender. There was no information about the patient's concurrent conditions, concomitant therapies or medical history provided. On unknown date in 2009, also reported as sometime in 2009 at the age of 2, the patient was vaccinated with a dose of GARDASIL (dose, route of administration, lot# and expiration date were not reported). No adverse effects were reported. No product quality complaint (PQC) was involved. The reporter had no details to provide, as the vaccine was not administered in their facility but it was listed on the medical history. Additional information has been requested.
Sex: F
Vaccine: MENB
Symptoms: Injection site erythema, Injection site swelling, Local reaction
Clinical narrative: This is a spontaneous report received from a non-contactable consumer (parent). A female patient of an unspecified age and ethnicity received second dose of TRUMENBA, via an unspecified route of administration on 16Jun2017, single dose, for immunisation. The patient's medical history and medications were not reported. On 17Jun2017, the patient experienced local reaction around the injection site. It was size of the palm of hand, swollen and red and the red area is just getting bigger at the time of the report. It was described as big red swollen area around the injection site which is not going side to side, it was in a kind of circle shape and now it's kind of spreading going side to side of the arm. The outcome of the event was not recovered. No follow-up attempts are possible. No further information is expected.
Age: 69.0
Sex: F
Vaccine: TDAP
Symptoms: Erythema, Injection site pain, Pruritus, Rash, Rash erythematous
Clinical narrative: By night soreness at site of injection began and has not gone away yet. By 6/19 arm started itching, extremely hot and red rash on arm. By then, arm more sore than ever - it hurt to touch it. Sprayed hydrogen peroxide and took away itching. By next day, redness was moving location in arm. Called nurse line who recommended doctor visit. Went to doctor who prescribed sulfamethoxazde/trimethoprim and hydrocortisone cream. Red is gone; arm still sore on places. Still not sure if infection or allergic reaction to meds.
Age: 69.0
Sex: F
Vaccine: TDAP
Symptoms: Skin warm, Tenderness
Clinical narrative: By night soreness at site of injection began and has not gone away yet. By 6/19 arm started itching, extremely hot and red rash on arm. By then, arm more sore than ever - it hurt to touch it. Sprayed hydrogen peroxide and took away itching. By next day, redness was moving location in arm. Called nurse line who recommended doctor visit. Went to doctor who prescribed sulfamethoxazde/trimethoprim and hydrocortisone cream. Red is gone; arm still sore on places. Still not sure if infection or allergic reaction to meds.
Age: 11.0
Sex: F
Vaccine: MNQ, TDAP
Symptoms: Crying, Feeling hot, Flushing
Clinical narrative: 5- 10 minutes after administration of Tdap and MCV4 Vaccine patient complained of feeling flushed and hot. She was given a cool cloth for her face. O2 Sat was 99%, Heart Rate was 88, BP 102/62, Resp. 16.  She was also given sprite to drink, her mother reported that she did not eat breakfast this morning prior to vaccinations. After 10 -15 minutes she reported feeling better. She was alert and talking able to follow directions throughout the incident. Called mother at 11:20 AM and she verbalized that she ate a biscuit and has been fine since the incident.  Informed her to call if any further issues arise or seek medical attention.
Age: 76.0
Sex: M
Vaccine: PPV
Symptoms: Glycosylated haemoglobin normal, Injection site erythema, Vaccination site pain
Clinical narrative: Pt. reports reaction started at 9:00 am on 06/22/17 he reported burning sensation and redness in his arm below the vaccine site that has not changed since the onset.
Age: 41.0
Sex: M
Vaccine: ANTH, SMALL, TYP
Symptoms: Chest pain, Dizziness, Dyspnoea, Echocardiogram normal, Troponin increased
Clinical narrative: Patient awakened with a c/o sharp substernal chest pain 5/10 in intensity and shortness of breath and some lightheadedness. He was admitted to the hospital for less than 24 hours and was discharged on NSAIDs and Colchicine. Symptoms rapidly resolved over the next few days and patient denies any recurrent or prolonged symptoms.
Age: 0.33
Sex: F
Vaccine: DTAP, HIBV, IPV, PPV
Symptoms: Muscular weakness, Musculoskeletal pain, Pain, Screaming
Clinical narrative: Screaming from about 4:15pm to 8:30/9 pm. Nothing helped. Everyone I moved her it got worse. Her legs were weak and if I tried to sit her down it appeared that her but was in pain too.
Age: 17.0
Sex: F
Vaccine: MENB
Symptoms: Abnormal behaviour, Asthenia, Injection site mass, Injection site pain
Clinical narrative: Per mom, she has a lump at injection site, soreness, unusual behavior-hyper, weakness.
Age: 22.0
Sex: F
Vaccine: JEV
Symptoms: Altered state of consciousness, Diarrhoea, Dizziness, Headache, Malaise
Clinical narrative: Received second dose of Japanese encephalitis vaccine on 5/1/2017.  Began to feel ill over the weekend: Nausea, vomiting,diarrhea. unsure of fever. Headache, felt faint, felt like passing out but did not.
Age: 22.0
Sex: F
Vaccine: JEV
Symptoms: Nausea, Vomiting
Clinical narrative: Received second dose of Japanese encephalitis vaccine on 5/1/2017.  Began to feel ill over the weekend: Nausea, vomiting,diarrhea. unsure of fever. Headache, felt faint, felt like passing out but did not.
Age: 4.0
Sex: F
Vaccine: DTAPIPV, MMRV
Symptoms: Lip swelling
Clinical narrative: Swollen Lips per mom. Mom states she gave Benadryl, Tylenol and motrin. Per mom, no hives. Pt not evaluated in clinic.
Age: 56.0
Sex: U
Vaccine: HEPA
Symptoms: Expired product administered, No adverse event
Clinical narrative: This spontaneous report was received from an administrator,referring to a 56 year old patient of unknown gender. The patient's medical history, concurrent conditions, concomitant medications, and historical drugs were not reported. On 31-MAY-2017, the patient was vaccinated with an expired dose of VAQTA 50/0.1 U/ml (route, dose, frequency and anatomical location were unknown) with Lot # L036449 and expiration date 26-MAY-2017, for prophylaxis. There was no product quality complaint. Additional information has been requested.
Age: 64.0
Sex: F
Vaccine: FLU4
Symptoms: Injection site pain
Clinical narrative: Not sure when but patient came back to pharmacy after receiving the vaccine and complained of arm pain near the point of injection.
Age: 71.0
Sex: M
Vaccine: PNC13
Symptoms: Injection site pain, Injection site paraesthesia
Clinical narrative: PATIENT REPORTING LINGERING PAIN AND TINGLING AT INJECTION SITE (06/23/2017).
Age: 50.0
Sex: F
Vaccine: DTAP, HEP
Symptoms: Vaccination site swelling
Clinical narrative: Localized swelling at vaccine site on left arm. Member had vaccine 6/21/2017. Small 4cm by 3 cm area mild swelling area is soft none tender to palpation. Skin temperature is normal.
Sex: U
Vaccine: HPV4
Symptoms: Expired product administered, No adverse event
Clinical narrative: This spontaneous report was received from a Registered Nurse referring to a patient of unknown age and gender. No information regarding the patient's medical history, concurrent conditions or concomitant therapies was provided. On 15-JUN-2017, the patient was inadvertently vaccinated with an expired dose of GARDASIL lot # M014929, expiration date on 27-MAY-2017 (strength, dose number, route and anatomical location were not provided) for prophylaxis. No adverse events reported. Additional information has been requested.
Age: 72.0
Sex: F
Vaccine: PPV
Symptoms: Erythema, Peripheral swelling
Clinical narrative: This spontaneous report was received from a certified medical assistant and refers to a 72 year old female patient. The patient did not have any concurrent condition, pertinent medical history or drug reactions or allergies. On 12-JUN-2017, the patient was vaccinated with PNEUMOVAX 23 lot # M042324, expiration date 10-JUN-2018 (dose and route were not reported) for prophylaxis. The patient did not take any concomitant medications. Approximately in June 2017, after vaccination, the patient developed redness and swelling to the right upper arm. Then patient went to a health facility and she was prescribed with Prednisone (manufacturer unknown) (dose and route were not reported) during 5 days, as treatment for the events. No laboratory diagnostic studies were performed and no product quality complaint (PQC) was involved. At the reporting time, the outcome of erythema and peripheral swelling was unknown. The reporter did not provide a causality assessment between the events and the PNEUMOVAX 23. Additional information has been requested.
Age: 73.0
Sex: M
Vaccine: VARZOS
Symptoms: Injection site rash
Clinical narrative: Patient reports a mild rash at site of injection.
Age: 1.67
Sex: F
Vaccine: VARCEL
Symptoms: Rash erythematous, Vaccination site reaction, Vaccination site vesicles
Clinical narrative: Seen for 6 cm red based rash with vesicles at site of vaccine.
Age: 16.0
Sex: F
Vaccine: MENB
Symptoms: Nausea, Presyncope, Somnolence
Clinical narrative: Nausea, pre-syncopal followed by syncopal episode. Experienced grogginess after episode that continues on day two.
Age: 50.0
Sex: F
Vaccine: HEPA, TDAP
Symptoms: Erythema, Pain of skin, Peripheral swelling, Skin warm
Clinical narrative: Left arm is swollen, red, hot and tender- approximately 2 in.
Age: 0.17
Sex: F
Vaccine: DTAPHEPBIP, HIBV, PNC13, RV1
Symptoms: Eating disorder, Pyrexia, Seizure, Vaccine positive rechallenge
Clinical narrative: High fever 104+ seizures and not eating.  She was admitted to the hospital.  The next time she got vaccines she had seizures and high fevers too.
Age: 0.5
Sex: F
Vaccine: DTAPHEPBIP, FLUX, PPV
Symptoms: Decreased appetite, Pyrexia, Seizure, Tremor, Vomiting
Clinical narrative: Fever over 104, seizures, tremoring, not feeding, vomiting.
Age: 55.0
Sex: F
Vaccine: UNK
Symptoms: Chest X-ray, Chills, Dizziness, Headache, Myalgia
Clinical narrative: Vaccine on 6/13 and developed nausea, vomiting, chills, undocumented fever, headache, myalgia, and dizziness.
Age: 55.0
Sex: F
Vaccine: UNK
Symptoms: Nausea, Pyrexia, Vomiting
Clinical narrative: Vaccine on 6/13 and developed nausea, vomiting, chills, undocumented fever, headache, myalgia, and dizziness.
Age: 75.0
Sex: M
Vaccine: TDAP
Symptoms: Arthralgia, Chills, Cough, Decreased appetite, Fatigue
Clinical narrative: By night got fever, was tired felt sleep. Had loss of appetite but no nausea/vomit/diarrhea. Lost 5 pounds in 1 week. Chills, sore joints, body aches and very bad cough. Called doctor after 72 hours and was told not to worry about it unless temperature spikes. Took guaifenesin for cough, helped somewhat, worse at night. Would cough for 10 minutes straight when lay down so it interfered with sleep. Cough not productive except once it was yellowish indicating infection. Still have a little cough last night. Fever everyday 100 degrees - 101 degrees until today. Fever gets wore on evening 99.7 degrees.
Age: 75.0
Sex: M
Vaccine: TDAP
Symptoms: Pain, Productive cough, Pyrexia, Sleep disorder, Somnolence
Clinical narrative: By night got fever, was tired felt sleep. Had loss of appetite but no nausea/vomit/diarrhea. Lost 5 pounds in 1 week. Chills, sore joints, body aches and very bad cough. Called doctor after 72 hours and was told not to worry about it unless temperature spikes. Took guaifenesin for cough, helped somewhat, worse at night. Would cough for 10 minutes straight when lay down so it interfered with sleep. Cough not productive except once it was yellowish indicating infection. Still have a little cough last night. Fever everyday 100 degrees - 101 degrees until today. Fever gets wore on evening 99.7 degrees.
Age: 75.0
Sex: M
Vaccine: TDAP
Symptoms: Weight decreased
Clinical narrative: By night got fever, was tired felt sleep. Had loss of appetite but no nausea/vomit/diarrhea. Lost 5 pounds in 1 week. Chills, sore joints, body aches and very bad cough. Called doctor after 72 hours and was told not to worry about it unless temperature spikes. Took guaifenesin for cough, helped somewhat, worse at night. Would cough for 10 minutes straight when lay down so it interfered with sleep. Cough not productive except once it was yellowish indicating infection. Still have a little cough last night. Fever everyday 100 degrees - 101 degrees until today. Fever gets wore on evening 99.7 degrees.
Age: 12.0
Sex: M
Vaccine: HPV4, MNQ, TDAP
Symptoms: Crying, Erythema, Headache, Mydriasis, Nightmare
Clinical narrative: The day after administration mom reported nightmares, fever, hot red face, dilated pupil, red eye, warm to touch, body ache, puffy tongue, fever T max 102, headache and crying lasting one day. Mom declined appointment for evaluation, pt not seen.
Age: 12.0
Sex: M
Vaccine: HPV4, MNQ, TDAP
Symptoms: Ocular hyperaemia, Pain, Pyrexia, Skin warm, Swollen tongue
Clinical narrative: The day after administration mom reported nightmares, fever, hot red face, dilated pupil, red eye, warm to touch, body ache, puffy tongue, fever T max 102, headache and crying lasting one day. Mom declined appointment for evaluation, pt not seen.
Age: 4.0
Sex: M
Vaccine: DTAPIPV, MMRV
Symptoms: Injection site swelling, Injection site warmth
Clinical narrative: (R) arm swelling S/P KINRIX (DTAP/IPV) vaccination. Diffuse swelling of (R) arm, greatest at the wrist and forearm, entire arm warm to touch. No cellulitis - no redness or tenderness.
Age: 49.0
Sex: M
Vaccine: PPV
Symptoms: Cellulitis, Injection site erythema, Injection site pain, Injection site swelling, Nausea
Clinical narrative: Red swelling at injection site, progressing by morning to painful red swelling, nausea, fever. Urgent care visit 28 hours after vaccination, given Keflex 500 mg (4 times a day) for 10 days.  Severe Cellulitis.
Age: 49.0
Sex: M
Vaccine: PPV
Symptoms: Pyrexia
Clinical narrative: Red swelling at injection site, progressing by morning to painful red swelling, nausea, fever. Urgent care visit 28 hours after vaccination, given Keflex 500 mg (4 times a day) for 10 days.  Severe Cellulitis.
Age: 72.0
Sex: F
Vaccine: PPV
Symptoms: Injection site erythema, Injection site swelling, Pain
Clinical narrative: Patient experienced redness and swelling around the site of injection (about 6 inches in diameter). She also reported extreme pain, greater than that of any other vaccine she has had in the past.
Age: 29.0
Sex: F
Vaccine: VARCEL
Symptoms: Exposure during pregnancy, Polymerase chain reaction positive, Skin lesion, Varicella post vaccine, Varicella virus test positive
Clinical narrative: This patient was 31 weeks pregnant at the time of exposure and was IgG negative. The partner of this individual received the Varicella vaccine on 4/3/17. He developed lesions on 4/24/17 which were PCR tested and found to be Varicella vaccine-strain (Merck). Patient received VZIgG on 5/4/17 but developed lesions on 5/9/17 and was admitted to hospital 5/10/17-5/20/17. Her lesions were PCR tested and confirmed to be Varicella (PCR testing for wild vs vaccine testing not performed).  For further details please contact County Public Health department.
Age: 6.0
Sex: F
Vaccine: HEP, IPV
Symptoms: Lymph node pain, Lymphadenopathy
Clinical narrative: Lymph nodes in right arm pit are swollen and very tender. Received Hep B and Polio in same arm right side.
Age: 1.0
Sex: M
Vaccine: DTAP, HEP, HIBV, MMR, VARCEL
Symptoms: Aggression, Crying, Developmental regression, Pain, Pyrexia
Clinical narrative: Very High fever for a few days following. Uncontrollable crying and noticable pain. Regression of speech/words and loss of abilities he was previously able to do. No longer repeats words back to us just babbles the same thing over and over, lots of temper tantrums where he was not doing previously.
Age: 77.0
Sex: F
Vaccine: PPV
Symptoms: Cellulitis, Peripheral swelling
Clinical narrative: Left arm swelling towards elbow. Doctor diagnosed cellulitis.
Age: 4.0
Sex: F
Vaccine: DTAPIPV, HEPA, MMR, VARCEL
Symptoms: Injection site cellulitis, Injection site erythema, Injection site pain, Injection site swelling, Injection site warmth
Clinical narrative: KINNRIX and Hep A given in (L) deltoid on 6/13/17. That evening. (L) arm noted to be red, swollen, warm to touch, and painful. Seen in clinic on 6/15/17 and started on clindamycin for cellulitis.
Age: 72.0
Sex: F
Vaccine: PPV
Symptoms: Abdominal pain upper, Headache, Injection site pain, Pain
Clinical narrative: Pt received vaccine on 6/21/17. Awoke 6/22/2017 AM with all over body aches, stomach achy and headache. Took TYLENOL, hydrated, rest. Next day 6/23/17 Pt felt better with exception of still sore at injection site.
Age: 11.0
Sex: M
Vaccine: HPV9, MNQ, TDAP
Symptoms: Erythema, Induration, Macule, Skin warm, Tenderness
Clinical narrative: 2 inch slightly indurated pink-colored macule, warm and slightly tender. Treatment: loratadine 10 mg once daily x 7 days. Cephalexin 250 mg, 2 capsules three times daily for 7 days.
Age: 31.0
Sex: F
Vaccine: TDAP
Symptoms: Muscle tightness
Clinical narrative: Jaw tightness approximately 40 min after injection. Approximately 10 hours later pt. is feeling "less tight".
Age: 17.0
Sex: F
Vaccine: HPV9, MENB, MNQ
Symptoms: Fall, Seizure, Syncope
Clinical narrative: 9:30 A.M. when receiving HPV # 3, patient stood and fainted. She exhibited seizure activity for several seconds. Her fall was broken by R.N. She remained supine for approx. 15 min. Her pulse was monitored and juice/snack were given. She walked out unassisted.
Age: 40.0
Sex: F
Vaccine: ANTH, TDAP
Symptoms: Alopecia, Amnesia, Diarrhoea, Dizziness, Fatigue
Clinical narrative: Developed numerous symptoms after the after receiving Anthrax #1 and TDaP in 2010. These included fatigue, nausea, dizziness. She never felt well again and went on to develop numerous other symptoms and began medical evaluations within 2 months. These symptoms include myalgias, short term memory loss, alopecia, lung infections, allergies, diarrhea, headache, orthostasis, unrefreshing sleep.
Age: 40.0
Sex: F
Vaccine: ANTH, TDAP
Symptoms: Headache, Hypersensitivity, Lung infection, Malaise, Myalgia
Clinical narrative: Developed numerous symptoms after the after receiving Anthrax #1 and TDaP in 2010. These included fatigue, nausea, dizziness. She never felt well again and went on to develop numerous other symptoms and began medical evaluations within 2 months. These symptoms include myalgias, short term memory loss, alopecia, lung infections, allergies, diarrhea, headache, orthostasis, unrefreshing sleep.
Age: 40.0
Sex: F
Vaccine: ANTH, TDAP
Symptoms: Nausea, Poor quality sleep
Clinical narrative: Developed numerous symptoms after the after receiving Anthrax #1 and TDaP in 2010. These included fatigue, nausea, dizziness. She never felt well again and went on to develop numerous other symptoms and began medical evaluations within 2 months. These symptoms include myalgias, short term memory loss, alopecia, lung infections, allergies, diarrhea, headache, orthostasis, unrefreshing sleep.
Age: 16.0
Sex: F
Vaccine: MENB, MNQ
Symptoms: Injection site erythema, Injection site pain, Injection site rash, Injection site urticaria, Injection site warmth
Clinical narrative: Received TRUMENBA 6/14/17 - welt around area on L upper arm on 6/15 - drew a circle around it then extended and 2 other red spots appeared. Became hot to touch, painful and pt had low grade temp.
Age: 16.0
Sex: F
Vaccine: MENB, MNQ
Symptoms: Pyrexia
Clinical narrative: Received TRUMENBA 6/14/17 - welt around area on L upper arm on 6/15 - drew a circle around it then extended and 2 other red spots appeared. Became hot to touch, painful and pt had low grade temp.
Age: 50.0
Sex: F
Vaccine: FLU4
Symptoms: Abdominal pain, Nausea, Vomiting
Clinical narrative: Abdominal pain, nauseated and vomited after flu shot administration. Rapid improvement in symptoms and returned to work same afternoon.
Age: 18.0
Sex: M
Vaccine: MENB, MNQ
Symptoms: Loss of consciousness
Clinical narrative: Passed out 15 seconds after giving injections. Was out for 10-15 seconds.
Age: 67.0
Sex: M
Vaccine: TDAP
Symptoms: Erythema, Gout, Pain in extremity, Peripheral swelling
Clinical narrative: Symptom consistent with gout. Appeared morning after vaccine, worse next day. Began to fade slightly 6 days after vaccine. 95% back to normal after 12 days. Symptoms were swollen, red, painful left great toe. Entire foot slightly swollen for a few days.
Age: 13.0
Sex: M
Vaccine: MNQ
Symptoms: Headache, Neck pain
Clinical narrative: Soreness in neck and head.
Age: 17.0
Sex: F
Vaccine: MENB, MNQ
Symptoms: Headache
Clinical narrative: Pt received TRUMENBA vaccine at 10:00 AM approximately 11:00 AM pt complained of headache lasting several hours. Headache resolved with in 24 hours.
Age: 71.0
Sex: F
Vaccine: PPV
Symptoms: Induration, Peripheral swelling, Skin warm
Clinical narrative: Arm swelling, induration and warmth.
Age: 2.0
Sex: F
Vaccine: PNC13, VARCEL
Symptoms: Injection site erythema, Injection site pain, Injection site swelling
Clinical narrative: 2 1/2 x 3 cm area of erythema/swelling to R upper arm in deltoid area. Tender to touch.
Age: 56.0
Sex: M
Vaccine: TDAP
Symptoms: Facial paralysis
Clinical narrative: Vaccine caused Bell's palsy.
Age: 12.0
Sex: M
Vaccine: MNQ
Symptoms: Erythema, Hypersensitivity, Pain in extremity, Peripheral swelling, Pruritus
Clinical narrative: Pt got MENACTRA and then at around 8pm that night his arm started aching then later started itching. On 6/23/17 he came in and his scan had swelling, itching, redness and it hurt. Localized allergic reaction.
Age: 39.0
Sex: F
Vaccine: FLU4
Symptoms: Chills, Feeling cold, Seizure like phenomena, Tremor
Clinical narrative: Patient received flu shot 10/8/15 and reported "cold shaking chills" with full body tremors after receiving flu shot same day. Reports full body shaking tremors started 9:30 or 10:00pm and lasted 45-60 minutes. This is discussed with Dr. Symptoms persisted on and off until 5:00am, tremors described "like a seizure", RN.
Age: 72.0
Sex: F
Vaccine: PPV
Symptoms: Body temperature increased, Dizziness, Nausea, Pain in extremity, Skin warm
Clinical narrative: Painful arm, nausea, dizziness, temp 100.4, armpit to elbow felt on fire.
Age: 15.0
Sex: F
Vaccine: HPV9
Symptoms: Muscle spasms, Seizure like phenomena, Syncope
Clinical narrative: Pt. experienced syncope with seizure like spasms shortly with receiving GARDASIL 9 - had second episode of syncope and seizure like spasm within 5-8 minutes of first.
Age: 0.17
Sex: F
Vaccine: DTAPIPVHIB, PNC13
Symptoms: Crying, Diet refusal, Emotional distress, Injection site swelling, Screaming
Clinical narrative: Injection site slightly swollen. Child began crying/screaming uncontrollably for 2-3 hours. Completely inconsolable, wouldn't eat. Went to a pediatric chiropractor for an adjustment, gave TYLENOL, and had a bath with Epsom salts, ginger, and lemon.
Age: 12.0
Sex: F
Vaccine: HPVX
Symptoms: Asthenia, Back pain, Fatigue, Headache, Hypoaesthesia
Clinical narrative: Severe fatigue, headache, neck and midline back pain, unable to bend forward, weak, feet tingling and going numb, throat and neck pain and tightness, no itching in throat, just hard to talk and strained to talk.
Age: 12.0
Sex: F
Vaccine: HPVX
Symptoms: Mobility decreased, Musculoskeletal stiffness, Neck pain, Neurological examination, Oropharyngeal pain
Clinical narrative: Severe fatigue, headache, neck and midline back pain, unable to bend forward, weak, feet tingling and going numb, throat and neck pain and tightness, no itching in throat, just hard to talk and strained to talk.
Age: 12.0
Sex: F
Vaccine: HPVX
Symptoms: Paraesthesia, Speech disorder, Streptococcus test negative, Throat tightness, Urine analysis normal
Clinical narrative: Severe fatigue, headache, neck and midline back pain, unable to bend forward, weak, feet tingling and going numb, throat and neck pain and tightness, no itching in throat, just hard to talk and strained to talk.
Age: 1.25
Sex: M
Vaccine: VARCEL
Symptoms: Decreased appetite, Headache, Pyrexia, Rash
Clinical narrative: Fevers 100.7-103.3. Rash on 6/24. Headache. Loss of appetite.
Age: 12.0
Sex: F
Vaccine: HPV4
Symptoms: Dyskinesia, Tic, Tremor
Clinical narrative: Continues Body And verbal TICS. Shaking, Jerking, Vocal all ongoing today.
Age: 12.0
Sex: M
Vaccine: HPV9
Symptoms: Abdominal pain upper, Erythema, Inflammation, Lip swelling, Nausea
Clinical narrative: On 06/19/17, approximately 2-3 hours after having the HPV vaccination, patient began complaining of being itchy on his head and neck area. He woke up the next morning, 6/20/17 with hives and rash all over his body. They were red, hot to the touch and itchy and covered most of his upper body. I took him to urgent care in the evening and he was treated with ZYRTEC. The hives/rash continued in 06/21/17 and we took him to the Emergency Room in the early hours of 06/21/17 because the hives/rash had spread across his entire body. He was treated with Prednisone, ZYRTEC, and additional medications. The hives and rash continued into 6/22/17 and in the early morning of 06/23/17 we again took him back to the Emergency Room due to continued hives/rash but he also began a fever and vomiting. He also had a swollen face, his airway was itchy, and his lips were swollen. He was treated with an EPIPEN and he was continued on the Prednisone and ZYRTEC. He was kept at the hospital under observation until approximately 6:00pm. He was released. Prior to his leaving the hospital it complained of a stomach ache. He was given nausea medication. His stomach ache continued and the rash/hives began to inflame and were extremely itchy into the early morning hours of 06/24/17. His lips were swollen and his hands and feet began to swell.  He continues to have the rash and hives all over his body.