chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 72.0
Sex: F
Vaccine: FLU4
Symptoms: Rash
Clinical narrative: Rash starting on chest and arms spreading to legs.
Age: 62.0
Sex: F
Vaccine: FLU3
Symptoms: Limb discomfort, Peripheral swelling, Skin discolouration
Clinical narrative: Black and blue mark, swelling in arm, discomfort on underside.
Age: 45.0
Sex: M
Vaccine: FLU4, PPV
Symptoms: Injection site erythema, Injection site pain, Injection site swelling, Injection site warmth
Clinical narrative: Pt received flu with PNEUMOVAX 23. A couple of hours later, pt noted pain at site. Next day c/o pain, redness, warmness with swelling at site of injections. Ibuprofen, TYLENOL, ice pack as needed.
Age: 68.0
Sex: F
Vaccine: FLU3
Symptoms: Cellulitis, Injection site erythema, Injection site pain
Clinical narrative: Patient returned 11/2/16 complaining of pain at site of injection. Slight redness present. Recommended seeing MD if troubles. Saw MD on 11/4/16. He said slight cellulitis. Ordered BACTRIM. Ordered Nabumetone 11/7/16
Age: 13.0
Sex: F
Vaccine: FLU4, HPV9
Symptoms: Chest X-ray, Diarrhoea, Feeling abnormal, Hallucination, visual, Laboratory test
Clinical narrative: Pt taken to ED as awakened in night C/O "feeling odd" fever at home. Vomiting and diarrhea at home. Mother relates child C/O seeing things not there: lights on clock w/o any light. Labs and CXR w/o concern. Child ill 10/22 and not ill 10/23.
Age: 13.0
Sex: F
Vaccine: FLU4, HPV9
Symptoms: Vomiting
Clinical narrative: Pt taken to ED as awakened in night C/O "feeling odd" fever at home. Vomiting and diarrhea at home. Mother relates child C/O seeing things not there: lights on clock w/o any light. Labs and CXR w/o concern. Child ill 10/22 and not ill 10/23.
Age: 72.0
Sex: M
Vaccine: FLU3, VARZOS
Symptoms: Injection site pain, Pain
Clinical narrative: With certain movements like moving arm towards the back and to side, there's a burning sensation and pain on the left upper arm. This started 2 days ago from today (11/6/16).
Age: 93.0
Sex: M
Vaccine: FLU3, PPV
Symptoms: Injection site bruising, Injection site pain, Injection site reaction, Injection site swelling, Tendonitis
Clinical narrative: Initial pain of upper arm (shoulder) - progressed to swelling of (R) shoulder and bruise at site of injection. Cold applications used with lotions. Medical office visit - refer to orthopedist - who took x-rays - injection of steroid - no help - pain continuous - radiating to hand.
Age: 93.0
Sex: M
Vaccine: FLU3, PPV
Symptoms: X-ray limb abnormal
Clinical narrative: Initial pain of upper arm (shoulder) - progressed to swelling of (R) shoulder and bruise at site of injection. Cold applications used with lotions. Medical office visit - refer to orthopedist - who took x-rays - injection of steroid - no help - pain continuous - radiating to hand.
Age: 52.0
Sex: F
Vaccine: FLU4
Symptoms: Insomnia, Pain in extremity
Clinical narrative: Pain from neck to fingers, difficulty sleeping within 24 hrs after administration. Steroid shot 10/15.
Age: 34.0
Sex: F
Vaccine: FLU4
Symptoms: Limb discomfort, Mobility decreased, Musculoskeletal pain
Clinical narrative: Pain in right shoulder and felt pressure during vaccination. Next day, unable to lift arm. Seen by provider in occupational health 10/06/16 Rx. ibuprofen, restrictions for (R) arm. Seen in OH 10/31/16 and discharged from care.
Age: 76.0
Sex: F
Vaccine: FLU3
Symptoms: Erythema, Local swelling, Vomiting
Clinical narrative: Patient sais she went home and has been vomiting. Area swollen and very red according to patient.
Age: 86.0
Sex: M
Vaccine: FLU3
Symptoms: Pain in extremity
Clinical narrative: Pt reports very sore arm.
Age: 13.0
Sex: F
Vaccine: HPV9
Symptoms: Chest X-ray, Diarrhoea, Hallucination, visual, Pyrexia, Vomiting
Clinical narrative: This spontaneous report as received from a nurse practitioner via a company representative refers to a currently 13-year-old female patient. The patient had no pertinent medical history and no concomitant medications. The patient's drug reactions and allergies were not reported. On an unknown date, the patient was vaccinated with her first and second dose of GARDASIL 9 (dose, lot#, expiration date and route of administration were not reported). On an unknown date, after receiving the second dose of GARDASIL 9, the patient experienced fever and recovered from the fever on an unknown date. On 21-OCT-2016, the patient was vaccinated with her third dose of GARDASIL 9 0.5 ml (lot#, expiration date and route of administration were not reported). On an unknown date in October 3016, after receiving the third dose of GARDASIL 9, the patient experienced vomiting, diarrhea and fever. The patient was taken to an emergency department and reported that she was "seeing things". She received ZOFRAN for the vomiting and TYLENOL. Unspecified lab tests and chest x-ray were performed (results were not provided). The outcome of the vomiting, diarrhea, "seeing things" and fever (after the third dose of GARDASIL 9) was recovered on an unknown date in 2016. The relatedness between the events and GARDASIL 9 was not provided. Additional information has been requested.
Age: 0.33
Sex: M
Vaccine: HIBV
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: Information has been received from a medical assistant referring to a patient of unknown age and gender. The patient's medical history, concurrent condition and concomitant medication were not reported. On 10-OCT-2016, the patient was vaccinated with an improperly stored dose of PEDVAXHIB (lot # M007762, expiration date 07-DEC-2018, dose and route were not reported). The vaccine had been stored under the temperature of 47.7 Fahrenheit degrees for 4 days 8 hours and 23 minutes. Digital date logger was involved. There was no previous temperature excursion. No adverse effect was reported. Additional information has been requested.
Sex: U
Vaccine: HPV4
Symptoms: Syncope
Clinical narrative: This spontaneous report received from a nurse via a company representative referred to a patient of unknown age and gender. The patient's medical history, concurrent conditions and concomitant medications were not reported. On an unknown date, the patient received GARDASIL (dose, frequency, route, lot number and expiry date were not reported) and experienced syncope. Outcome of the event was unknown and causality was not reported. Additional information has been requested.
Age: 69.0
Sex: M
Vaccine: PPV
Symptoms: Tremor
Clinical narrative: This spontaneous report as received from a pharmacist refers to a 69 year old male patient, who is also a physician. Patient's medical history, information about concomitant drugs or concurrent conditions were not provided. The patient had no drug reactions or allergies. On 23-SEP-2016, the patient was vaccinated with the first dose of PNEUMOVAX 23 (lot # L035687, expiry date: 16-FEB-2017), intramuscularly (arm, side not specified). On approximately 07-OCT-2016, (reported as: "approximately 14 days after the dose") the patient experienced tremors in the arm at the injection site in which a primary dose of PNEUMOVAX 23 was administered. The patient reported, that the tremor was "a little bothersome, but not to the point of limiting his function". He also stated, that the tremors were intermittent, not associated with activity or any particular time of the day and that tremor started in the muscle at the vaccination site and then radiated down the entire arm. No treatment was given and no lab diagnostics studies were performed. The patient did not recover from the event of tremor by the time of the report. The relatedness between the event and vaccination with PNEUMOVAX 23 was not reported. Additional information has been requested.
Sex: U
Vaccine: VARCEL
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: Information has been received from a registered nurse referring to unspecified patients of unknown age and gender. The patients' pertinent medical history, drug reactions/allergies and concomitant medication were unknown. On unknown dates the patients were each vaccinated with a dose of improperly stored (-14 Degrees Celsius for 16 hours) VARIVAX (lot # L048465, expiration date 02-DEC-2017, dose and route unknown). No adverse experience had been reported. There was no temperature excursion issue previously. Additional information has been requested.
Sex: F
Vaccine: PPV
Symptoms: Adverse reaction
Clinical narrative: This spontaneous report was received via a company representative from a female patient of unknown age who was reporting on herself. Her medical history, concurrent conditions and concomitant medications were not reported. On an unknown date, the patient was vaccinated with a dose of pneumococcal vaccine, polyvalent (23-valent) (manufacturer unknown) (dose, route of administration, lot # and expiration date were not reported). On an unknown date, the patient experienced an unspecified adverse reaction. The outcome of the adverse event was unknown. The reporter considered adverse reaction to be related to pneumococcal vaccine, polyvalent (23-valent) (manufacturer unknown). Additional information has been requested.
Sex: U
Vaccine: HEP
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: Information has been received from a pharmacist referring to unknown number of patients of unknown age and gender. The patients' medical histories, concurrent conditions and concomitant therapies were not reported. On unknown dates, 3 doses of improperly stored RECOMBIVAX HB (lot # L048848, dose, route and expiration date not reported) had been administered to patients. The doses of vaccine were improperly stored at 35 degree Fahrenheit for 1 hour. There was no previous temperature excursion. Data logger was involved. No adverse effects were reported. Additional information has been requested.
Sex: F
Vaccine: PPV
Symptoms: Expired product administered, No adverse event
Clinical narrative: Information has been received on 21-OCT-2016 from a medical assistant who reported that a dose of PNEUMOVAX 23 (lot# L003227, expiration date 13-OCT-2016) may have been administered (date not reported) to a female patient (age unknown) inadvertently after the expiration date. No adverse effects reported. No additional information available. Additional information has been requested.
Age: 15.0
Sex: U
Vaccine: MMRV
Symptoms: Drug administered to patient of inappropriate age, Inappropriate schedule of drug administration, No adverse event
Clinical narrative: Information had been received on 21-OCT-2016 from a nurse who reported that a patient (gender not reported), who is 15 years old, received a dose of PROQUAD (lot# M007963, expiration date 15-APR-2017) on 30-AUG-2016. Patient then received a second dose of PROQUAD (lot# M006102, expiration date 01-AUG-2017) on 13-OCT-2016; this is outside the recommendations per the PROQUAD prescribing information. No adverse effects reported. No further information provided. Additional information has been requested.
Sex: U
Vaccine: MMR
Symptoms: Extra dose administered, No adverse event
Clinical narrative: This spontaneous report was received from the patient's mother referring to a patient of unknown age and gender. The patient's concurrent conditions and medical history were not reported. A nurse from the doctor's office indicated to the patient's mother that the patient was given 2 injections of M-M-R II (dose, route, anatomical location and lot # were not reported). No adverse effects were reported. A Product Quality Complaint was not involved. Additional information is not expected since the physician cannot be contacted.
Sex: F
Vaccine: MMR
Symptoms: Injection site erythema, Injection site pain
Clinical narrative: This spontaneous report as received via a company representative from a female patient of unknown age who is also a nurse midwife. Information regarding the patient's concurrent conditions and medical history was not provided. On an unknown date, the patient was vaccinated with a dose of M-M-R II, subcutaneously, in the right arm (lot number and expiration date were not reported). There were no concomitant medications reported. On an unknown date, after the patient received the vaccine, she experienced a red painful spot on the right arm at the injection site. The patient did not seek for medical attention and she did not received any treatment for the adverse events. The patient was not hospitalized and she did not die. There was no product quality complaint involved. At the reporting time, the patient had not recovered from the events. The causality assessment was not provided. Additional information has been requested.
Age: 74.0
Sex: M
Vaccine: PPV
Symptoms: Erythema, Injection site pain, Pain in extremity, Peripheral swelling
Clinical narrative: Stung when vaccine administered. At night stretched arm and notice it was swollen, a little red, painful upon touch. Pharmacist recommended ice and took 2 TYLENOL. Pharmacist called on morning of 11/8 to check in. A dull ache remains.
Sex: U
Vaccine: HEPA
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report was received from a medical assistant referring to an unknown number of patients of unknown age and gender. The patients' pertinent medical history, drug reaction/allergies or concomitant medication were not reported. On an unknown dates, the patients were vaccinated with improperly stored doses of VAQTA lot #: M009377 with expiration date: 17-JUN-2017, lot #: M011116 with expiration date: 17-JUN-2017 and lot # M017982 with expiration date: 13-SEP-2017 (route and dose were not reported). The reporter stated that the vaccine temperature excursions were of 35F for 30 minutes and 34.2F for 2 hours. No adverse event was reported in any patient. There was no product quality complaint (PQC) involved. This is one of several reports received from the same reporter. Additional information is not expected as there is not consent to follow-up.
Sex: M
Vaccine: VARZOS
Symptoms: Ear pain, Herpes zoster, Rash vesicular
Clinical narrative: This spontaneous report was received from a nurse practitioner via a company representative referring to a 68 year old male patient. The patient's concurrent conditions and medical history were not provided. The patient's drug reactions and allergies were not reported. Approximately in 2015, reported as "about a year and a half ago", the patient was vaccinated with ZOSTAVAX (dose scheduled, route of administration, lot # and expiration date were not provided). There were not concomitant medications reported. On 17-OCT-2016, the patient went to see a health care professional for "ear pains and no rash" and was given an unspecified treatment for this. On 19-OCT-2016, the patient visited the physician office, "for a vesicular rash on the left side of the head by the ear and lots of pain". The nurse practitioner diagnosed this rash as shingles. The patient was given a high dose of unspecified pain medication for treatment. At the time of this report, the outcome of shingles was reported as not recovered. The outcome of ear pains was not reported. The causality between the events and ZOSTAVAX was not provided. Additional information has been requested.
Age: 13.0
Sex: F
Vaccine: HPV9
Symptoms: Injection site pain
Clinical narrative: This spontaneous report was received from the patient's mother and refers to her 13 year old daughter. The patient's concurrent conditions included seasonal allergy and drug hypersensitivity to AUGMENTIN when she was little. Approximately in September 2016 (reported as "about two months ago"), the patient was vaccinated with her first dose of GARDASIL 9 one dose of a three dose series (concentration, route, anatomical place of vaccination, lot # and expiration date were not provided). Concomitant therapies included an unspecified allergy medicine. Approximately in 2016, the patient experienced injection site pain. Despite the patient did not seek for medical attention she received treatment for the adverse event. Approximately in 2016 (reported as "lasted about one month", the patient recovered from injection site pain. Additionally the reporter stated that the patient seemed to be better and she was due to get her next shot on "Friday". The mother was not sure what to do about the next shot since the pain lasted for so long. Nevertheless, the reporter did not provide a causality assessment between the injection site pain and GARDASIL 9. Additional information has been requested.
Sex: F
Vaccine: VARZOS
Symptoms: Extra dose administered, Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report as received from a pharmacist refers to a female patient of unknown age. The patient's pertinent medical history, concomitant medications, drug reactions and allergies were not reported. On 09-OCT-2016, the patient was vaccinated with a properly stored dose of ZOSTAVAX (dose, route of administration, lot# and expiration date were not reported). On 28-OCT-2016, the patient inadvertently received a second dose of ZOSTAVAX lot# M030140, expiration date 28-OCT-2016 (dose and route of administration were not reported). No adverse effect was reported. No product quality complaint was involved. Additional information has been requested.
Age: 0.17
Sex: M
Vaccine: DTAPHEPBIP, HIBV, PNC13, RV1
Symptoms: Irritability, Pyrexia, Rash
Clinical narrative: This case was reported by a physician via call center representative and described the occurrence of fever in a 2-month-old male patient who PEDIARIX. Concomitant products included Hib vaccine, PREVNAR 13 and Rotavirus vaccine. On24th October 2016, the patient received PEDIARIX. In October 2016, 2 days after receiving PEDIARIX, the patient experienced fever, irritability and rash. On an unknown date, the outcome of the fever was recovered/resolved and the outcome of the irritability and rash were unknown. It was unknown if the reporter considered the fever, irritability and rash to be related to PEDIARIX. Additional details were provided as follows: The patient went to the emergency room. The healthcare professional had no product information. The body temperature was recorded as 100.8 degree F. In October 2016, less than a week after receiving PEDIARIX, the patient experienced rash.
Sex: U
Vaccine: PPV
Symptoms: Injection site pain
Clinical narrative: This spontaneous report as received from a registered nurse via a company representative refers to 2 patients of unknown age. There was no information about the patient's concomitant medications, allergies and pertinent medical history reported. On unknown dates, the patients were vaccinated with PNEUMOVAX 23 one dose, (lot#, expiry date, route and site of administration were not reported). On unknown dates, the patients experienced injection site pain. Unspecified treatment was given for the event. On an unknown date, the patient recovered from the injection site pain. The patient seek medical attention via contacting the nurse. The relatedness between the event and PNEUMOVAX 23 was not reported. Additional information is not expected as the reporter did not give a consent for further contact.
Age: 14.0
Sex: F
Vaccine: HPV9
Symptoms: Urticaria
Clinical narrative: This spontaneous report as received from a physician refers to a 14-year-old female patient. The patient's concurrent conditions included asthma exercise induced, allergic rhinitis, eczema and Raynaud's phenomenon. The patient had no drug reactions and no allergies. On an unknown date in June 2016 (reported as "sometime in June, 2016"), the patient was vaccinated with GARDASIL 9 (dose, lot #, expiration date and route of administration were not reported). Concomitant therapies included albuterol NASACORT. On an unknown date in June 2016, within hours after vaccination, the patient developed severe urticarial, over most of her body. She received an unspecified treatment and the hives subsided within one day. The outcome of the event was recovered on an unknown date in June 2016. The relatedness between the event and GARDASIL 9 was not provided. Additional information has been requested.
Age: 18.0
Sex: M
Vaccine: HEPA
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report as received from a nurse refers to a 18 year old male patient. There was no information about the patient's concomitant medications, allergies and pertinent medical history reported. On an unknown date, the patient aged 18 years 6 months, was vaccinated with an adult - 1 ml dose of properly stored VAQTA, 50 U/1 ml, lot # reported as M034896, expiry date 26-MAY-2017 (route and site of administration were not reported). No adverse effect reported. Additional information is not expected as there was no consent for follow up.
Sex: U
Vaccine: PPV
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: Information has been received from a nurse referring to multiple unspecified patients of unknown age and gender. On unknown dates the patients were vaccinated with improperly stored doses of PNEUMOVAX 23 (lot # M035104, expiration date 06-MAY-2018, 0.5 ml, intramuscular). The vaccine was stored under 0.69 degree centigrade for 18 hours and 45 minutes. There was no previous temperature excursion. Data logger was involved. No adverse effects were reported. No PQC was involved. Additional information has been requested.
Age: 1.1
Sex: U
Vaccine: MMRV
Symptoms: Injection site erythema, Pyrexia, Rhinorrhoea
Clinical narrative: This spontaneous report as received from a licensed practical nurse refers to a 13 month old patient of unknown gender. The patient's medical history, concurrent conditions and concomitant medications were not reported. On 31-OCt-2016, the patient was vaccinated with a dose of PROQUAD (lot # M006105, expiration date 01-AUG-2017, 0.5 ml, subcutaneously). On an unknown date in 2016, the patient experienced a red reaction at the injection site (on the leg), a low grade fever and a runny nose. The outcome of the adverse events was unknown. The relatedness between the adverse events and PROQUAD was not provided. Additional information has been requested.
Sex: F
Vaccine: PPV
Symptoms: Injection site pain
Clinical narrative: This spontaneous report was received from a physician assistant via a company representative and refers to a female patient of unknown age. The patient's pertinent medical history included being diabetic. The patient did not have any drug reactions or allergies known by reporter. No concomitant medications were reported. On an unknown date, the patient was vaccinated with a 0.5 ml dose (also reported as "one shot") of PNEUMOVAX 23 (route of administration, lot# and expiration date were not reported). On an unknown date, reported as "the day after" vaccination, the patient experienced soreness at the injection site. It was unknown whether the patient sought medical attention. No lab diagnostic studies were performed. The outcome of the adverse event was unknown. The relatedness between the adverse event and PNEUMOVAX 23 was not reported. 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 concerning a patient of unknown age and gender. The patient's concurrent conditions and medical history was not provided. On 31-OCT-2016, the patient was vaccinated with an improperly stored dose of PNEUMOVAX 23 lot # M005287, expiration date 08-OCT-2017, (strength, dose and route were not provided), which was exposed to 8.6 Celsius Degrees for 25 minutes. It was reported that the vaccine was previously exposed to a temperature of 8.1 Celsius Degrees for 5 minutes. The temperature excursion was detected by a data logger. There were no concomitant medications and adverse effects reported. No product quality complaint was involved. Additional information has been requested.
Sex: U
Vaccine: HPV9
Symptoms: Inappropriate schedule of drug administration, Interchange of vaccine products, No adverse event
Clinical narrative: This spontaneous report as received from a medical assistant refers to a patient of unknown gender and age. Information about the patient's pertinent medical history, concomitant medications and drug reactions or allergies was not reported. In October 2013 (reported as: "3 years ago"), the patient was vaccinated with the first dose of GARDASIL (dose, route of administration, lot# and expiration date were not reported). On 24-OCT-2016, the patient appeared in the medical assistant's office to receive a dose of GARDASIL 9 (dose, route of administration, lot# and expiration date were not reported), as the second dose in the HPV series, which was outside the prescribing information for both vaccines. No adverse effects were reported. Additional information has been requested.
Age: 1.25
Sex: F
Vaccine: MMR
Symptoms: Expired product administered, No adverse event
Clinical narrative: This spontaneous report as received from a registered nurse refers to a patient of unknown age and gender. No pertinent medical history, drug reactions/allergies and concomitant medications were reported. On 03-NOV-2016, the patient was vaccinated with an expired dose of M-M-R II (lot # K021152 and expiry date 02-NOV-2016) (dosing regimen unknown). No adverse effects reported. No temperature excursions were reported. No product quality complaint was filed. Additional information has been requested.
Sex: U
Vaccine: RV5
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report was received from a Licensed practical Nurse and refers to a multiple unspecified patients of unknown ages and genders. The patients' pertinent medical history, concurrent conditions, drug reactions or allergies were not reported. Between 03-NOV-2016 and 07-NOV-2016, the patients were vaccinated improperly stored ROTATEQ, 2 ml, lot number M004544, expiration date 18-OCT-2017, (frequency, route and anatomical location were not reported). Temperature of 48.9 Fahrenheit degrees, 45 minutes of time frame and there was a digital data logger involved. No previous temperature excursion was involved. No product quality complain was involved. At the time of reporting, no adverse effects were reported. No other suspect or concomitant therapies were reported. This is one of two reports from the same reporter. Additional information has been requested.
Sex: U
Vaccine: HPV4
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report was received from a Licensed practical Nurse and refers to a multiple unspecified patients of unknown ages and genders. The patients' pertinent medical history, concurrent conditions, drug reactions or allergies were not reported. Between 03-NOV-2016 and 07-NOV-2016, the patients were vaccinated improperly stored GARDASIL, lot number L037554, expiration date 25-DEC-2017, (frequency, route and anatomical location were not reported). Temperature of 48.9 Fahrenheit degrees, 45 minutes of time frame and there was a digital data logger involved. No previous temperature excursion was involved. No product quality complain was involved. At the time of reporting, no adverse effects were reported. No other suspect or concomitant therapies were reported. This is one of two reports from the same reporter. Additional information has been requested.
Age: 34.0
Sex: M
Vaccine: RAB
Symptoms: Animal bite, Dyspnoea, Nausea, Pain, Palpitations
Clinical narrative: 3 hrs after Day 7 Rabies vaccine pt developed hives, nausea, vomiting, SOB, racing heart. Prescribed BENADRYL and prednisone 20 mg 2 x D. On day 3 visit, pt c/o nausea and vomiting and rash but was also on AUGMENTIN for dog bites to hands. Was advised to call primary MD. On 11/1/16 patient had contacted MD who attributed rash to AUGMENTIN. Felt better but still had rash.
Age: 34.0
Sex: M
Vaccine: RAB
Symptoms: Pruritus, Rash, Urticaria, Vomiting
Clinical narrative: 3 hrs after Day 7 Rabies vaccine pt developed hives, nausea, vomiting, SOB, racing heart. Prescribed BENADRYL and prednisone 20 mg 2 x D. On day 3 visit, pt c/o nausea and vomiting and rash but was also on AUGMENTIN for dog bites to hands. Was advised to call primary MD. On 11/1/16 patient had contacted MD who attributed rash to AUGMENTIN. Felt better but still had rash.
Age: 54.0
Sex: F
Vaccine: PPV
Symptoms: Chest X-ray normal, Full blood count normal, Headache, Nausea, Pyrexia
Clinical narrative: Low grade Temp 100.3. SOA, nausea. Headache 1-2 hrs after vaccination.
Age: 0.33
Sex: F
Vaccine: RV1
Symptoms: Abnormal faeces, Diarrhoea
Clinical narrative: Pt. experienced explosive episodes of diarrhea 6 days after administration of ROTARIX. Mother described as large, yellow, no blood, foul smelling stools for over 48 hours. Evaluated by medical provider.
Age: 69.0
Sex: M
Vaccine: PNC13
Symptoms: Musculoskeletal pain, X-ray limb
Clinical narrative: Pt is experiencing shoulder pain since injections. Has seen Dr. for pain. Shoulder X-ray done. Dr did not confirm pain from vaccine-Follow up 2/2017.
Age: 35.0
Sex: M
Vaccine: HEPA, PPV, TDAP
Symptoms: Cellulitis
Clinical narrative: Given Tdap, PNEUMOVAX, Hep A. Two given in that (L) arm and documentation says (2) given in (R) arm. (I suspect this was a Tdap RXN superficial cellulitis patch approx. 12 cm x 14 cm.
Age: 75.0
Sex: F
Vaccine: PPV, PPV
Symptoms: Fatigue, Inflammation, Injection site erythema, Musculoskeletal stiffness, Nausea
Clinical narrative: Swelling, inflammation and pain of entire left arm. Nausea and fatigue. Muscle stiffness, erythema, at injection site.
Age: 75.0
Sex: F
Vaccine: PPV, PPV
Symptoms: Pain in extremity, Peripheral swelling
Clinical narrative: Swelling, inflammation and pain of entire left arm. Nausea and fatigue. Muscle stiffness, erythema, at injection site.
Age: 75.0
Sex: F
Vaccine: PPV, PPV
Symptoms: Erythema, Injection site erythema, Injection site pain, Injection site swelling, Injection site warmth
Clinical narrative: Swelling, inflammation and pain of entire left arm. Nausea and fatigue. Muscle stiffness, erythema, at injection site.
Age: 75.0
Sex: F
Vaccine: PPV, PPV
Symptoms: Pain in extremity, Peripheral swelling, Skin warm
Clinical narrative: Swelling, inflammation and pain of entire left arm. Nausea and fatigue. Muscle stiffness, erythema, at injection site.
Age: 58.0
Sex: F
Vaccine: PPV
Symptoms: Injection site erythema, Injection site pain, Injection site swelling, Mobility decreased, Skin warm
Clinical narrative: On 11/2/15 11:00 am vaccine administered. 4:00 pm Pain to left deltoid and upper arm. 8:00 pm injection site redness, swelling and unable to move arm, warm to touch, but no fever.
Age: 50.0
Sex: F
Vaccine: MMR, VARCEL
Symptoms: Local swelling, Pain in extremity, Skin warm
Clinical narrative: On 11/9/16 (L) arm hurting with sharp pains. Swollen area and warm to touch. Pt took BENADRYL and TYLENOL. On 11/10/16 (L) arm with 1 1/2" x 2" swollen warm area, very tender to touch. Going to Primary Care doctor.
Age: 10.0
Sex: M
Vaccine: TDAP
Symptoms: Erythema, Local swelling
Clinical narrative: Red and swollen approx. 5-6 cm to LA. Ice compress, BENADRYL, MOTRIN.
Age: 1.5
Sex: F
Vaccine: DTAP, HEPA
Symptoms: Blood glucose, Computerised tomogram, Dyskinesia, Electrocardiogram, Gaze palsy
Clinical narrative: 11-9-16 Patient seen at ED with seizure; described as localized/staring about 3 minutes; (L) gaze deviation, (R) upper extremity jerking; gagging per ED note believed to be related to DTAP.
Age: 1.5
Sex: F
Vaccine: DTAP, HEPA
Symptoms: Metabolic function test, Retching, Seizure, Staring
Clinical narrative: 11-9-16 Patient seen at ED with seizure; described as localized/staring about 3 minutes; (L) gaze deviation, (R) upper extremity jerking; gagging per ED note believed to be related to DTAP.
Age: 84.0
Sex: F
Vaccine: PPV
Symptoms: Injection site erythema, Injection site pain, Injection site swelling
Clinical narrative: Site reaction - swelling, redness, tenderness.
Age: 75.0
Sex: M
Vaccine: PNC13
Symptoms: Injection site pain, Injection site swelling
Clinical narrative: Patient experienced swelling, tenderness, pain at injection site.
Age: 74.0
Sex: F
Vaccine: PNC13
Symptoms: Injection site erythema, Injection site rash
Clinical narrative: Redness, rash on localized area above elbow to mid-deltoid area.
Age: 47.0
Sex: M
Vaccine: HEP
Symptoms: Blood culture negative, Chest X-ray normal, Dehydration, Dizziness, Full blood count normal
Clinical narrative: Within 4 hours, pt. developed fever increased to 103 degrees F and dizziness. Went to ER that evening. Blood work, blood cultures, and U/A all negative. Antibiotics were prescribed as a precautionary measure. F/U at clinic on 8/16/16: Fever persists increased to 103 degrees F. Advised to continue with ABX and increase fluids. On 8/17/16 returned to ER with N/V, fever increased to 103 degrees F, dehydration and received IV fluids and ROCEPHIN, antiemetic, with PO antiemetic upon D/C. Used x 24 hours. Repeated labs and new CXR, all negative. Pt. feeling well by 8/18/16 evening/8/19/16 A.M.
Age: 47.0
Sex: M
Vaccine: HEP
Symptoms: Nausea, Pyrexia, Urine analysis normal, Vomiting
Clinical narrative: Within 4 hours, pt. developed fever increased to 103 degrees F and dizziness. Went to ER that evening. Blood work, blood cultures, and U/A all negative. Antibiotics were prescribed as a precautionary measure. F/U at clinic on 8/16/16: Fever persists increased to 103 degrees F. Advised to continue with ABX and increase fluids. On 8/17/16 returned to ER with N/V, fever increased to 103 degrees F, dehydration and received IV fluids and ROCEPHIN, antiemetic, with PO antiemetic upon D/C. Used x 24 hours. Repeated labs and new CXR, all negative. Pt. feeling well by 8/18/16 evening/8/19/16 A.M.
Age: 11.0
Sex: M
Vaccine: HPV9
Symptoms: Immediate post-injection reaction, Loss of consciousness, Seizure like phenomena
Clinical narrative: Immediately after administration of HPV #2 pt had "seizure like activity" and passed out. Placed patient on floor with elevated legs and came around quickly. Responded to name. Place seen by pediatrician.
Age: 12.0
Sex: M
Vaccine: VARCEL
Symptoms: Immediate post-injection reaction, Swelling face, Urticaria
Clinical narrative: Immediately following immunization patient developed widespread hives with facial swelling (peak approx. 1 hour after vaccine). Resolved after dose of BENADRYL.
Age: 14.0
Sex: M
Vaccine: HPV4
Symptoms: Electroencephalogram normal, Immediate post-injection reaction, Loss of consciousness, Muscle twitching, Nuclear magnetic resonance imaging normal
Clinical narrative: Immediately following injection, patient slumped back and had brief twitching of limbs with transient loss of consciousness. For several minutes afterwards had some residual weakness left arm.
Age: 4.0
Sex: F
Vaccine: DTAPIPV, MMRV
Symptoms: Injection site erythema, Injection site swelling, Injection site warmth, Pruritus
Clinical narrative: Pt received KINRIX and PROQUAD on 9/28/2016. Parent noted on next day Left thigh, warm, swelling and redness. Pt C/O itching. Site evaluated by pediatrician.
Age: 19.0
Sex: F
Vaccine: MENB
Symptoms: Injection site erythema, Injection site pain, Injection site warmth
Clinical narrative: Left Deltoid - 9cm raised warm erythematous area. No exudate. Painful.
Age: 19.0
Sex: F
Vaccine: FLU4, MENB, MNQ, FLUX, MENB, MNQ
Symptoms: Cellulitis, Erythema, Headache, Pain, Pain in extremity
Clinical narrative: Initial unsolicited report received from other non health care professional (reference number: 2016383100) on 31 Oct 2016. This case involves the 20-year-old female patient who was vaccinated with a fifth dose of INFLUENZA QUADRIVAL A-B MULTIDOSE VACCINE PRESERVED (Influenza vaccine) (batch number: UI684AD, expiry date, route, dose not reported) via intramuscular route in the left arm, dose of MENVEO (batch number, expiry date, dose and route was not reported) in the right arm and 0.5 ml second dose of TRUMENBA (batch number: M77282, expiry date: 30 Jun 2017) at 03:03pm via intramuscular route in the right deltoid on 30 Sep 2016. Patient's pre-existing physician diagnosed allergies, birth defects, medical conditions (specify) revealed that, the patient had abdominal pain on 30 Nov 2012. Lab test includes GI f/u due Feb 2013, seen GI, s/p endoscopy, WNL, stress related, negative PPD, 0 mm induration read by ibgrn on 22 July 2016 and eyehglasses started on 30 Sep 2016. Temperature was 97.8. No non drug allergies. Examination was reported as eyes normal, ears normal, neck supple, throat and mouth normal, lymph node none, chest normal, lunngs clear to auscultation, heart RR, no murmur, and skin right arm had large area o0f erythema around the vaccine ebtry point, quite warm and tender and extends to upper forearm and genitals no lesions. Illness at time of vaccination revealed that patient had sinusitis. Concomitant medications include amoxicillin 500 mg TID for four days (three times a day) on 30 Sep 2016 to 31 Oct 2016 for sinusitis. On 30 Sep 2016, same day post vaccination, the patient's arm hurt and started swelling and turned red. It was reported that, the day after it continue to swell and red area enlarged and patient hurts to move it, touch it. On unspecified date, the patient had slightly headache and was warm to touch. Patient also experienced cellulitis. It was reported that, Patient denies any previous reaction to vaccine. Patient required ER?doctor visit. Lab data was not reported. Corrective treatment includes amoxicillin 500mg-125 mg BID for cellulitis. The outcome of the events were not reported. Upon internal review, the company decided to consider the event serious because of important medical event: cellulitis. List of documents held by sender: none.; Sender's Comments: This case concerns female patient who received INFLUENZA QUADRIVAL A-B MULTIDOSE VACCINE PRESERVED simultaneously with TRUMENBA and MENVEO and developed cellulitis and headache. Cellulitis was occurred on right arm where MENVEO and TRUMENBA was given. So that event was considered unlisted for INFLUENZA vaccine. Time to onset is compatible with the role of MENVEO VACCINE and TRUMENBA vaccine. Further information regarding etiological work up, and investigation results, reaction to previous vaccination to rule out the alternative cause are needed for complete assessment of the case.
Age: 19.0
Sex: F
Vaccine: FLU4, MENB, MNQ, FLUX, MENB, MNQ
Symptoms: Peripheral swelling, Skin warm
Clinical narrative: Initial unsolicited report received from other non health care professional (reference number: 2016383100) on 31 Oct 2016. This case involves the 20-year-old female patient who was vaccinated with a fifth dose of INFLUENZA QUADRIVAL A-B MULTIDOSE VACCINE PRESERVED (Influenza vaccine) (batch number: UI684AD, expiry date, route, dose not reported) via intramuscular route in the left arm, dose of MENVEO (batch number, expiry date, dose and route was not reported) in the right arm and 0.5 ml second dose of TRUMENBA (batch number: M77282, expiry date: 30 Jun 2017) at 03:03pm via intramuscular route in the right deltoid on 30 Sep 2016. Patient's pre-existing physician diagnosed allergies, birth defects, medical conditions (specify) revealed that, the patient had abdominal pain on 30 Nov 2012. Lab test includes GI f/u due Feb 2013, seen GI, s/p endoscopy, WNL, stress related, negative PPD, 0 mm induration read by ibgrn on 22 July 2016 and eyehglasses started on 30 Sep 2016. Temperature was 97.8. No non drug allergies. Examination was reported as eyes normal, ears normal, neck supple, throat and mouth normal, lymph node none, chest normal, lunngs clear to auscultation, heart RR, no murmur, and skin right arm had large area o0f erythema around the vaccine ebtry point, quite warm and tender and extends to upper forearm and genitals no lesions. Illness at time of vaccination revealed that patient had sinusitis. Concomitant medications include amoxicillin 500 mg TID for four days (three times a day) on 30 Sep 2016 to 31 Oct 2016 for sinusitis. On 30 Sep 2016, same day post vaccination, the patient's arm hurt and started swelling and turned red. It was reported that, the day after it continue to swell and red area enlarged and patient hurts to move it, touch it. On unspecified date, the patient had slightly headache and was warm to touch. Patient also experienced cellulitis. It was reported that, Patient denies any previous reaction to vaccine. Patient required ER?doctor visit. Lab data was not reported. Corrective treatment includes amoxicillin 500mg-125 mg BID for cellulitis. The outcome of the events were not reported. Upon internal review, the company decided to consider the event serious because of important medical event: cellulitis. List of documents held by sender: none.; Sender's Comments: This case concerns female patient who received INFLUENZA QUADRIVAL A-B MULTIDOSE VACCINE PRESERVED simultaneously with TRUMENBA and MENVEO and developed cellulitis and headache. Cellulitis was occurred on right arm where MENVEO and TRUMENBA was given. So that event was considered unlisted for INFLUENZA vaccine. Time to onset is compatible with the role of MENVEO VACCINE and TRUMENBA vaccine. Further information regarding etiological work up, and investigation results, reaction to previous vaccination to rule out the alternative cause are needed for complete assessment of the case.
Age: 19.0
Sex: F
Vaccine: FLU4, MENB, MNQ, FLUX, MENB, MNQ
Symptoms: Peripheral swelling, Skin warm, Tenderness, Vaccination site erythema, Vaccination site pain
Clinical narrative: Initial unsolicited report received from other non health care professional (reference number: 2016383100) on 31 Oct 2016. This case involves the 20-year-old female patient who was vaccinated with a fifth dose of INFLUENZA QUADRIVAL A-B MULTIDOSE VACCINE PRESERVED (Influenza vaccine) (batch number: UI684AD, expiry date, route, dose not reported) via intramuscular route in the left arm, dose of MENVEO (batch number, expiry date, dose and route was not reported) in the right arm and 0.5 ml second dose of TRUMENBA (batch number: M77282, expiry date: 30 Jun 2017) at 03:03pm via intramuscular route in the right deltoid on 30 Sep 2016. Patient's pre-existing physician diagnosed allergies, birth defects, medical conditions (specify) revealed that, the patient had abdominal pain on 30 Nov 2012. Lab test includes GI f/u due Feb 2013, seen GI, s/p endoscopy, WNL, stress related, negative PPD, 0 mm induration read by ibgrn on 22 July 2016 and eyehglasses started on 30 Sep 2016. Temperature was 97.8. No non drug allergies. Examination was reported as eyes normal, ears normal, neck supple, throat and mouth normal, lymph node none, chest normal, lunngs clear to auscultation, heart RR, no murmur, and skin right arm had large area o0f erythema around the vaccine ebtry point, quite warm and tender and extends to upper forearm and genitals no lesions. Illness at time of vaccination revealed that patient had sinusitis. Concomitant medications include amoxicillin 500 mg TID for four days (three times a day) on 30 Sep 2016 to 31 Oct 2016 for sinusitis. On 30 Sep 2016, same day post vaccination, the patient's arm hurt and started swelling and turned red. It was reported that, the day after it continue to swell and red area enlarged and patient hurts to move it, touch it. On unspecified date, the patient had slightly headache and was warm to touch. Patient also experienced cellulitis. It was reported that, Patient denies any previous reaction to vaccine. Patient required ER?doctor visit. Lab data was not reported. Corrective treatment includes amoxicillin 500mg-125 mg BID for cellulitis. The outcome of the events were not reported. Upon internal review, the company decided to consider the event serious because of important medical event: cellulitis. List of documents held by sender: none.; Sender's Comments: This case concerns female patient who received INFLUENZA QUADRIVAL A-B MULTIDOSE VACCINE PRESERVED simultaneously with TRUMENBA and MENVEO and developed cellulitis and headache. Cellulitis was occurred on right arm where MENVEO and TRUMENBA was given. So that event was considered unlisted for INFLUENZA vaccine. Time to onset is compatible with the role of MENVEO VACCINE and TRUMENBA vaccine. Further information regarding etiological work up, and investigation results, reaction to previous vaccination to rule out the alternative cause are needed for complete assessment of the case.
Age: 19.0
Sex: F
Vaccine: FLU4, MENB, MNQ, FLUX, MENB, MNQ
Symptoms: Vaccination site warmth
Clinical narrative: Initial unsolicited report received from other non health care professional (reference number: 2016383100) on 31 Oct 2016. This case involves the 20-year-old female patient who was vaccinated with a fifth dose of INFLUENZA QUADRIVAL A-B MULTIDOSE VACCINE PRESERVED (Influenza vaccine) (batch number: UI684AD, expiry date, route, dose not reported) via intramuscular route in the left arm, dose of MENVEO (batch number, expiry date, dose and route was not reported) in the right arm and 0.5 ml second dose of TRUMENBA (batch number: M77282, expiry date: 30 Jun 2017) at 03:03pm via intramuscular route in the right deltoid on 30 Sep 2016. Patient's pre-existing physician diagnosed allergies, birth defects, medical conditions (specify) revealed that, the patient had abdominal pain on 30 Nov 2012. Lab test includes GI f/u due Feb 2013, seen GI, s/p endoscopy, WNL, stress related, negative PPD, 0 mm induration read by ibgrn on 22 July 2016 and eyehglasses started on 30 Sep 2016. Temperature was 97.8. No non drug allergies. Examination was reported as eyes normal, ears normal, neck supple, throat and mouth normal, lymph node none, chest normal, lunngs clear to auscultation, heart RR, no murmur, and skin right arm had large area o0f erythema around the vaccine ebtry point, quite warm and tender and extends to upper forearm and genitals no lesions. Illness at time of vaccination revealed that patient had sinusitis. Concomitant medications include amoxicillin 500 mg TID for four days (three times a day) on 30 Sep 2016 to 31 Oct 2016 for sinusitis. On 30 Sep 2016, same day post vaccination, the patient's arm hurt and started swelling and turned red. It was reported that, the day after it continue to swell and red area enlarged and patient hurts to move it, touch it. On unspecified date, the patient had slightly headache and was warm to touch. Patient also experienced cellulitis. It was reported that, Patient denies any previous reaction to vaccine. Patient required ER?doctor visit. Lab data was not reported. Corrective treatment includes amoxicillin 500mg-125 mg BID for cellulitis. The outcome of the events were not reported. Upon internal review, the company decided to consider the event serious because of important medical event: cellulitis. List of documents held by sender: none.; Sender's Comments: This case concerns female patient who received INFLUENZA QUADRIVAL A-B MULTIDOSE VACCINE PRESERVED simultaneously with TRUMENBA and MENVEO and developed cellulitis and headache. Cellulitis was occurred on right arm where MENVEO and TRUMENBA was given. So that event was considered unlisted for INFLUENZA vaccine. Time to onset is compatible with the role of MENVEO VACCINE and TRUMENBA vaccine. Further information regarding etiological work up, and investigation results, reaction to previous vaccination to rule out the alternative cause are needed for complete assessment of the case.