chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 0.32
Sex: M
Vaccine: RV5
Symptoms: Diarrhoea, Diet refusal, Gastroenteritis rotavirus, General physical health deterioration, Hypokalaemia
Clinical narrative: Information has been received from Sanofi Pasteur MSD (MFR # DE-1577272925-E2015-05044) on 13-MAY-2015. Case was received from a physician on 12-MAY-2015. Case is medically confirmed. A male patient received the complete immunisations series with three doses of ROTATEQ orally starting at the age of seven weeks on 09-APR-2013 (D1, lot#. J000051, expiry: 30-SEP-2014), on 10-MAY-2013 (D2, lot # J000051, expiry: 30-SEP-2014) and on 14-JUN-2013 (D3, lot #. J000554, expiry: 30-SEP-2014). One and a half year later at the age of 2 years, on 01-MAY-2015, the patient developed diarrhea. On 03-MAY-2015 during the night he additionally developed recurrent vomiting. On the next day, on 04-MAY-2015, he was presented to emergency room due to vomiting and reduced general condition. He was hospitalised on that day. On admission physical investigation revealed slightly reduced turgor, dry mucous membranes and slightly reddened pharynx. Laboratory test results: 04-MAY-2015: pH: 7.32, Carbon dioxide partial pressure (pCO2): 3.59 Hydrogencarbonate (HCO3): 16.1, Base excess: 11.2, CRP: 32.4. Urine- acetone: +++ (positive) (check up showed normal results), blood gases analysis: pH: 7.38, Base excess: -8.6, potassium: 2.7, potassium (serum): 2.68. Check up on 05-MAY-2015: pH: 7.38, Base excess: -5.9, potassium: 3.21. Check up on 05-MAY-2015, 06:00 pm: potassium: normal. The patient was treated with infusion therapy consisting of sodium chloride 0.9% and glucose-electrolytes mixture with potassium supplementary. Stool test was positive for rotavirus. Following diagnoses were established: rotavirus gastroenteritis, hypokalaemia, food refusal, vomiting and acetonuria. On 07-MAY-2015 the patient was discharged in good general condition.
Age: 0.32
Sex: M
Vaccine: RV5
Symptoms: Ketonuria, Mucosal dryness, PCO2, Pharyngeal erythema, Rotavirus test positive
Clinical narrative: Information has been received from Sanofi Pasteur MSD (MFR # DE-1577272925-E2015-05044) on 13-MAY-2015. Case was received from a physician on 12-MAY-2015. Case is medically confirmed. A male patient received the complete immunisations series with three doses of ROTATEQ orally starting at the age of seven weeks on 09-APR-2013 (D1, lot#. J000051, expiry: 30-SEP-2014), on 10-MAY-2013 (D2, lot # J000051, expiry: 30-SEP-2014) and on 14-JUN-2013 (D3, lot #. J000554, expiry: 30-SEP-2014). One and a half year later at the age of 2 years, on 01-MAY-2015, the patient developed diarrhea. On 03-MAY-2015 during the night he additionally developed recurrent vomiting. On the next day, on 04-MAY-2015, he was presented to emergency room due to vomiting and reduced general condition. He was hospitalised on that day. On admission physical investigation revealed slightly reduced turgor, dry mucous membranes and slightly reddened pharynx. Laboratory test results: 04-MAY-2015: pH: 7.32, Carbon dioxide partial pressure (pCO2): 3.59 Hydrogencarbonate (HCO3): 16.1, Base excess: 11.2, CRP: 32.4. Urine- acetone: +++ (positive) (check up showed normal results), blood gases analysis: pH: 7.38, Base excess: -8.6, potassium: 2.7, potassium (serum): 2.68. Check up on 05-MAY-2015: pH: 7.38, Base excess: -5.9, potassium: 3.21. Check up on 05-MAY-2015, 06:00 pm: potassium: normal. The patient was treated with infusion therapy consisting of sodium chloride 0.9% and glucose-electrolytes mixture with potassium supplementary. Stool test was positive for rotavirus. Following diagnoses were established: rotavirus gastroenteritis, hypokalaemia, food refusal, vomiting and acetonuria. On 07-MAY-2015 the patient was discharged in good general condition.
Age: 0.32
Sex: M
Vaccine: RV5
Symptoms: Skin turgor decreased, Urine ketone body absent, Urine ketone body present, Vomiting, pH body fluid increased
Clinical narrative: Information has been received from Sanofi Pasteur MSD (MFR # DE-1577272925-E2015-05044) on 13-MAY-2015. Case was received from a physician on 12-MAY-2015. Case is medically confirmed. A male patient received the complete immunisations series with three doses of ROTATEQ orally starting at the age of seven weeks on 09-APR-2013 (D1, lot#. J000051, expiry: 30-SEP-2014), on 10-MAY-2013 (D2, lot # J000051, expiry: 30-SEP-2014) and on 14-JUN-2013 (D3, lot #. J000554, expiry: 30-SEP-2014). One and a half year later at the age of 2 years, on 01-MAY-2015, the patient developed diarrhea. On 03-MAY-2015 during the night he additionally developed recurrent vomiting. On the next day, on 04-MAY-2015, he was presented to emergency room due to vomiting and reduced general condition. He was hospitalised on that day. On admission physical investigation revealed slightly reduced turgor, dry mucous membranes and slightly reddened pharynx. Laboratory test results: 04-MAY-2015: pH: 7.32, Carbon dioxide partial pressure (pCO2): 3.59 Hydrogencarbonate (HCO3): 16.1, Base excess: 11.2, CRP: 32.4. Urine- acetone: +++ (positive) (check up showed normal results), blood gases analysis: pH: 7.38, Base excess: -8.6, potassium: 2.7, potassium (serum): 2.68. Check up on 05-MAY-2015: pH: 7.38, Base excess: -5.9, potassium: 3.21. Check up on 05-MAY-2015, 06:00 pm: potassium: normal. The patient was treated with infusion therapy consisting of sodium chloride 0.9% and glucose-electrolytes mixture with potassium supplementary. Stool test was positive for rotavirus. Following diagnoses were established: rotavirus gastroenteritis, hypokalaemia, food refusal, vomiting and acetonuria. On 07-MAY-2015 the patient was discharged in good general condition.
Sex: U
Vaccine: MMR
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report was received from a Registered nurse refers to a patient of unknown age. Patient medical history and current condition was not reported. On 07-MAY-2015 the patient was vaccinated with MMR II (lot # K009192 and expiry date reported as 27-JUN-2016) which underwent an unsupported temperature excursion via intramuscular route. No adverse effects reported. The outcome of the event was unknown. This is one of the three reports received from the same reporter. Additional information has been requested.
Age: 83.0
Sex: F
Vaccine: PNC13
Symptoms: Injection site cellulitis, Injection site erythema, Injection site warmth
Clinical narrative: Erythema, warmth (R) arm below injection site. Differential include cellulitis.
Sex: F
Vaccine: HPV4
Symptoms: Exposure during pregnancy
Clinical narrative: Information has been received from a male consumer concerning his girlfriend of unknown age. The patient's medical history, concurrent condition and concomitant therapy were not provided. On an unknown date the patient was vaccinated with a dose of GARDASIL (lot#, expiration date, dose and route not provided), while she was pregnant. The last menstrual period (LMP) and estimated date of delivery (EDD) was unknown. Additional information is not expected because the reporter declined to participate in answering questions within this report and no demographics of the physician was provided.
Age: 67.0
Sex: F
Vaccine: PNC13
Symptoms: Injection site erythema, Injection site warmth
Clinical narrative: Right upper arm erythema and warmth circumference of upper arm from deltoid to bicep and where PREVNAR 13 admin 1 week ago. Treat with BENADRYL and KEFLEX.
Sex: M
Vaccine: MMR
Symptoms: Mumps
Clinical narrative: This spontaneous report as received from a consumer as part of a marketing research program conducted by agency, refers to a male patient of unknown age. On an unknown date, the patient was vaccinated with MMR II (dose, route, lot # and expiration date were not reported). On an unknown date, the patient experienced MMR II as a child. The patient's outcome was unknown. The relatedness between the vent and MMR II was unknown. Additional information is not expected as the reporter did not wish to be contacted.
Age: 1.0
Sex: M
Vaccine: HEPA, MMR, VARCEL
Symptoms: Febrile convulsion
Clinical narrative: On 5/14/15 patient was taken to ER by EMS for febrile seizure. Patient's temp at the time of seizure was 103.6. ER Physician informed mom that febrile seizure was caused by MMR vaccine.
Age: 70.0
Sex: F
Vaccine: PNC13
Symptoms: Injection site erythema, Injection site reaction, Injection site warmth
Clinical narrative: 5-7 days after vaccine patient has erythema and warmth approximately 3cm width band around upper left arm just below location of PREVNAR 13 administration. Treat w/BENADRYL and cool compress.
Age: 68.0
Sex: F
Vaccine: PNC13
Symptoms: Erythema, Musculoskeletal stiffness, Pruritus, Skin exfoliation
Clinical narrative: Vax on 12 May 15, 14 May redness on (R) arm and neck, 17 May stiff in neck. Notes itching on redness. Back of neck scaly/flaky. Husband applied alcohol w/o relief.
Age: 71.0
Sex: F
Vaccine: PNC13
Symptoms: Injection site erythema, Injection site pain, Vaccination site rash
Clinical narrative: Arm rash at and below vaccination site started day after and worsened through 4/14. Arm: warm raised patches of diffuse erythema, (+) TTP distal to deltoid.
Age: 75.0
Sex: F
Vaccine: PNC13
Symptoms: Rash erythematous, Skin warm
Clinical narrative: Red rash started day after vaccination. Spread and worsened by 4/18. Exam: Circumferential band of erythema, warm, raised (non-tender) approx 5 am cranial-caudal.
Sex: U
Vaccine: DTAPHEPBIP, HEP
Symptoms: Extra dose administered, No adverse event
Clinical narrative: This spontaneous report was received from a licensed practical nurse refers to a patient of unknown age and gender. The patient's pertinent medical history and concurrent conditions were not provided. On 11-MAY-2015, the patient was vaccinated with a d ose of RECOMBIVAX HB (route, lot number and expiration date were not provided). Other suspect therapies also administered on 11-MAY-2015, included PEDIARIX (route, lot number and expiration date were not provided). Concomitant medication information was not provided. On 11-MAY-2015, the patient experienced overdose as received a dose of RECOMBIVAX HB and a dose of PEDIARIX. No adverse effects were reported. At the time of the report, the patient status was unknown. Additional information has been requested.
Sex: U
Vaccine: VARCEL
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report as received from a registered nurse refers to five patients of unknown age and gender. Concurrent conditions, pertinent medical history, drug reactions or allergies were not reported. On an unknown in 2015, over the past two weeks, the five patients were vaccinated with improperly stored doses of (Merck) VARIVAX (dose, dose number, route, anatomical location, lot number and expiration date were unspecified). No adverse events reported. Concomitant therapies were not reported. The outcome of the event was unknown. Additional information has been requested.
Age: 11.0
Sex: F
Vaccine: MNQ, TDAP
Symptoms: Eyelid oedema, Tenderness
Clinical narrative: Patient received Menactra R deltoid and Boostrix L deltoid. R eye later became swollen. The eye is only uncomfortable if she touches the lower lid where it is swollen.
Age: 57.0
Sex: F
Vaccine: HEP
Symptoms: Injection site swelling
Clinical narrative: Reports feeling bump at injection site 1-2 days post vaccination. No pain, no redness. Seen by this RN on 05/16/2015 who told patient to see her PCP. Patient declined.This RN palpated a distinct firmness in left upper arm. About 3cm across with irregular margins. Was not superfiscial- was about 2-4 cm from surface of arm.  No fever, no other sxs. Full ROM in arm. The area appeared to be accurate placement of IM vaccine.
Age: 1.83
Sex: F
Vaccine: FLU3, MMR, MMR
Symptoms: Alopecia, Arthritis, Breast swelling, Cough, Diarrhoea
Clinical narrative: Day 84 mumpy measles on skin, high fever, body rash, vomiting, hair loss, diarrhea, chronic in all ears, screaming, coughing. Breathing difficulties, swelling neck, face, etc, etc, etc. Infectious disease, arthritis Dr neurologist. Breast swollen. Seizure activities.
Age: 1.83
Sex: F
Vaccine: FLU3, MMR, MMR
Symptoms: Dyspnoea, Infection, Local swelling, Measles, Pyrexia
Clinical narrative: Day 84 mumpy measles on skin, high fever, body rash, vomiting, hair loss, diarrhea, chronic in all ears, screaming, coughing. Breathing difficulties, swelling neck, face, etc, etc, etc. Infectious disease, arthritis Dr neurologist. Breast swollen. Seizure activities.
Age: 1.83
Sex: F
Vaccine: FLU3, MMR, MMR
Symptoms: Rash generalised, Screaming, Seizure, Swelling face, Vomiting
Clinical narrative: Day 84 mumpy measles on skin, high fever, body rash, vomiting, hair loss, diarrhea, chronic in all ears, screaming, coughing. Breathing difficulties, swelling neck, face, etc, etc, etc. Infectious disease, arthritis Dr neurologist. Breast swollen. Seizure activities.
Age: 1.83
Sex: F
Vaccine: FLU3, MMR, MMR
Symptoms: Alopecia, Laboratory test, Pyrexia, Rash generalised, Rash morbilliform
Clinical narrative: Day 84 mumpy measles on skin, high fever, body rash, vomiting, hair loss, diarrhea, chronic in all ears, screaming, coughing. Breathing difficulties, swelling neck, face, etc, etc, etc. Infectious disease, arthritis Dr neurologist. Breast swollen. Seizure activities.
Age: 1.83
Sex: F
Vaccine: FLU3, MMR, MMR
Symptoms: Seizure
Clinical narrative: Day 84 mumpy measles on skin, high fever, body rash, vomiting, hair loss, diarrhea, chronic in all ears, screaming, coughing. Breathing difficulties, swelling neck, face, etc, etc, etc. Infectious disease, arthritis Dr neurologist. Breast swollen. Seizure activities.
Sex: U
Vaccine: PPV
Symptoms: Expired product administered, No adverse event
Clinical narrative: This spontaneous report was received from health care worker refers to a patient of unknown age and gender. Patient medical history and current conditions was not reported. On 14-MAY-2015 the patient was vaccinated with expired dose of PNEUMOVAX 23 (lot # J013555 and expiry date 2-MAY-2015) of dose 0.5 ml via subcutaneous route. No adverse effect was reported. The outcome of the event was unknown. Additional information has been requested.
Sex: U
Vaccine: HEPA, MMR
Symptoms: Extra dose administered, Incorrect product formulation administered, No adverse event, Wrong technique in drug usage process
Clinical narrative: This spontaneous report was received from a licensed practical nurse refers to a patient of unknown age and gender. The patient's pertinent medical history and concurrent conditions were not provided. On 12-MAY-2015, the patient was vaccinated with 2 doses of MMR II (route, lot numbers and expiration dates were not provided). Other suspect therapies included VAQTA (route, lot number and expiration date were not provided). Concomitant therapy information was not provided. On 12-MAY-2015, the patient experienced wrong technique in drug usage process and overdose as the first dose of MMR II was reconstituted properly using the supplied diluent and the second dose of MMR II, administered on the same date, was reconstituted using VAQTA instead of diluent. No adverse effects were reported. At the time of the report, the patient status was unknown. Additional information has been requested.
Sex: U
Vaccine: MMRV
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report was received from a pharmacist refers to an unspecified patient of unknown age and gender. No pertinent medical history was reported. On an unknown date, the patient was vaccinated with PROQUAD (Merck) (dose, route, lot # were not reported) that was stored improperly. No adverse effects reported. Additional information has been requested.
Sex: M
Vaccine: VARCEL
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report was received from a certified nurse assistant refers to a male patient of unknown age. The patient's pertinent medical history and concurrent conditions were not provided. On 24-APR-2015, the patient was vaccinated with the first dose of (Merck) VARIVAX lot number K016127, expiration date 23-SEP-2016 (route was not provided). Concomitant therapy information was not provided. On 24-APR-2015, the patient received an improperly stored first dose of (Merck) VARIVAX. No adverse symptoms were reported. The temperature excursion for (Merck) VARIVAX was supported in-house stability data. At the time of the report, the patient status was unknown. Additional information has been requested.
Age: 46.0
Sex: F
Vaccine: TDAP
Symptoms: Axillary pain, Injection site swelling, Mobility decreased
Clinical narrative: Began swelling at injection site up to 4" diam. by day 3 with pain into armpit area, unable to lift arm past shoulder height until day 7.
Age: 13.0
Sex: M
Vaccine: HEPA, HPV4, MNQ
Symptoms: Erythema, Nodule, Peripheral swelling
Clinical narrative: Knot, red swollen size of a baseball on right arm.
Age: 85.0
Sex: F
Vaccine: PNC13
Symptoms: Blood glucose decreased, Headache, Pain in extremity, Pyrexia, Tremor
Clinical narrative: Four hours after injection, shaking profusely, temp 103 degrees. Admitted to Hospital-April 29th released May 1, 2015. Pain in left calf-headache.
Age: 1.02
Sex: F
Vaccine: HEPA, VARCEL
Symptoms: Injection site erythema, Injection site rash, Pharyngeal erythema, Rash erythematous
Clinical narrative: Few hours after vaccine on (L) thigh (either VZ or hep A) red rash to shot site then over 2 hours spread of rash to chest. No other sxs. initially in UC noted to have red throat -> sent to ER (no oral findings). Given IM DECADRON and sent home.
Sex: U
Vaccine: HPV4
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report was received from a health care worker refers to 5 unspecified patients. Patients medical history and current condition was not reported. On an unknown date the patients were vaccinated with improperly stored doses of GARDASIL (Lot number and expiry date not reported). No adverse effects reported. Product quality complaint was not reported. The outcome of the event was unknown. This is one of the two reports received from the same reporter. Additional information has been requested.
Age: 6.0
Sex: M
Vaccine: PPV
Symptoms: Antibody test negative, Extra dose administered, Pneumonia
Clinical narrative: This spontaneous report was received from a registered nurse via a sales representative concerning a 6 year old male patient. The concurrent conditions included immunodeficiency (type unspecified). In approximately 2014 (reported as "last year"), the patient was vaccinated with a first dose of PNEUMOVAX 23. (Dose and route were not reported). In 2014, after vaccination the patient had titers drawn (unspecified date), and then the titers came back as "negative". The nurse stated the patient was hospitalized (unspecified location and date), "6 times last year" due to developing pneumonia. The patient's immunologist had a written order for the patient to receive the vaccine according to his "record of a treatment plan that was supposed to draw out the patient's titers". On 14-MAY-2015, the patient was vaccinated with another (second dose) of PNEUMOVAX 23 and had titers drawn. Receiving the PNEUMOVAX 23, was outside of the recommended dosing instructions. The patient did not seek medical attention. The outcome of pneumonia was unknown. 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 health care worker refers to 10 unspecified patients. Patients medical history and current condition was not reported. On an unknown date the patients were vaccinated with improperly stored doses or ROTATEQ (Lot number and expiry date not reported). No adverse effects reported. Product quality complaint was not reported. The outcome of the event was unknown. This is one of the two reports from the same reporter. Additional information has been requested.
Age: 67.0
Sex: F
Vaccine: VARZOS
Symptoms: Blister, Burning sensation, Pruritus, Urticaria
Clinical narrative: Broke out in hive like blisters/rash. Itching and burning about week after. Problem with both outer/inner on the below elbows.
Age: 64.0
Sex: F
Vaccine: VARZOS
Symptoms: Extra dose administered
Clinical narrative: Patient given ZOSTAVAX at pharmacy on 4-27-15. Also, patient was given ZOSTAVAX at doctor office on 7-21-10.
Age: 62.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site rash, Injection site swelling
Clinical narrative: Softball area rash/swell around injection site; BENADRYL and ice treatment; follow up 5/12/15 with almost complete symptom resolution.
Age: 54.0
Sex: F
Vaccine: TDAP
Symptoms: Abdominal pain upper, Arthralgia, Computerised tomogram, Erythema, Lymphadenopathy
Clinical narrative: 4/10 arm swollen, stomach ache. 4/11 fever, joint pain. 4/12, arm swelling, red streaks down upper arm, up onto shoulder, lymph nodes swollen.
Age: 54.0
Sex: F
Vaccine: TDAP
Symptoms: Peripheral swelling
Clinical narrative: 4/10 arm swollen, stomach ache. 4/11 fever, joint pain. 4/12, arm swelling, red streaks down upper arm, up onto shoulder, lymph nodes swollen.
Age: 71.0
Sex: F
Vaccine: PNC13
Symptoms: Pruritus, Rash
Clinical narrative: Rash on arm with itching.  Patient will take Benadryl.
Age: 65.0
Sex: F
Vaccine: PNC13
Symptoms: Chest pain, Chills, Dehydration, Injection site erythema, Injection site pain
Clinical narrative: 2 days after receiving pneumococcal vaccine pt. noticed erythema and some pain in her (L) upper arm radiating to (L) upper chest. Fasted x 3 days (religious) 5/7, 5/8 and 5/9. On 5/8 developed 104 degree fever w/ chills. Went to ER. Returned to ER after syncopal spell (per ambulance); dx'd viral infection and dehydration. Seen 5/13 today in clinic continues to have pain and erythema.
Age: 65.0
Sex: F
Vaccine: PNC13
Symptoms: Pyrexia, Syncope, Viral infection
Clinical narrative: 2 days after receiving pneumococcal vaccine pt. noticed erythema and some pain in her (L) upper arm radiating to (L) upper chest. Fasted x 3 days (religious) 5/7, 5/8 and 5/9. On 5/8 developed 104 degree fever w/ chills. Went to ER. Returned to ER after syncopal spell (per ambulance); dx'd viral infection and dehydration. Seen 5/13 today in clinic continues to have pain and erythema.
Age: 77.0
Sex: F
Vaccine: PNC13
Symptoms: Injection site erythema, Injection site warmth, Pruritus
Clinical narrative: Pt. experienced itchiness first day, few hours after injection. She came in to the pharmacy on 5th day, left arm presented large "warm" erythema around injection site, pt. was informed to contact her primary care physician.
Age: 60.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site erythema, Injection site warmth
Clinical narrative: Large red patch, warm to touch, spanning about 4" in diameter at injection site. Patient does not complain of pain/itch.
Age: 77.0
Sex: F
Vaccine: PNC13, PNC13
Symptoms: Computerised tomogram head normal, Electrocardiogram normal, Fall, Head injury, Hyperhidrosis
Clinical narrative: Pain at site of injection that went up the side of her neck and down the right side of her right arm and had nausea in the evening of day of injection. Next morning 5/9/15 at 5:00 am sweating and nausea and fell down and hit head. Went to Emergency Department.
Age: 77.0
Sex: F
Vaccine: PNC13, PNC13
Symptoms: Injection site pain, Nausea, Neck pain, X-ray limb normal
Clinical narrative: Pain at site of injection that went up the side of her neck and down the right side of her right arm and had nausea in the evening of day of injection. Next morning 5/9/15 at 5:00 am sweating and nausea and fell down and hit head. Went to Emergency Department.
Age: 77.0
Sex: F
Vaccine: PNC13, PNC13
Symptoms: Blood lactic acid, Blood magnesium, Chills, Computerised tomogram head, Differential white blood cell count
Clinical narrative: Pain at site of injection that went up the side of her neck and down the right side of her right arm and had nausea in the evening of day of injection. Next morning 5/9/15 at 5:00 am sweating and nausea and fell down and hit head. Went to Emergency Department.
Age: 77.0
Sex: F
Vaccine: PNC13, PNC13
Symptoms: Electrocardiogram, Fall, Full blood count, Hyperhidrosis, Metabolic function test
Clinical narrative: Pain at site of injection that went up the side of her neck and down the right side of her right arm and had nausea in the evening of day of injection. Next morning 5/9/15 at 5:00 am sweating and nausea and fell down and hit head. Went to Emergency Department.
Age: 77.0
Sex: F
Vaccine: PNC13, PNC13
Symptoms: Nausea, Pain in extremity, Syncope, Troponin, Vomiting
Clinical narrative: Pain at site of injection that went up the side of her neck and down the right side of her right arm and had nausea in the evening of day of injection. Next morning 5/9/15 at 5:00 am sweating and nausea and fell down and hit head. Went to Emergency Department.
Age: 77.0
Sex: F
Vaccine: PNC13, PNC13
Symptoms: X-ray limb
Clinical narrative: Pain at site of injection that went up the side of her neck and down the right side of her right arm and had nausea in the evening of day of injection. Next morning 5/9/15 at 5:00 am sweating and nausea and fell down and hit head. Went to Emergency Department.
Age: 71.0
Sex: F
Vaccine: PNC13
Symptoms: Myalgia, Pain, Swelling
Clinical narrative: May 4th 2015, vaccine was administered to me 5/5/2015 at 4am I woke with pain and swelling over my entire body, some places were worst than other body parts, pain was mostly in my muscles.
Age: 4.0
Sex: F
Vaccine: DTAPIPV, MMRV
Symptoms: Erythema, Skin warm, Swelling
Clinical narrative: Hot to touch, redness, swelling, no temp. Patient seen in office 5-13-15 given prescription for BACTRIM for 10 days.
Sex: U
Vaccine: VARCEL
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report was received from a Certified Medical Assistant referring to a patient of unknown age and gender. No concurrent conditions or medical history were reported. On 11-MAY-2015, the patient was vaccinated with a dose of (Merck) VARIVAX (dose, Lot No. and route were not reported). No concomitant therapy was provided. The reported stated that the (Merck) VARIVAX administered was improperly stored. No adverse effect reported. Additional information has been requested.
Age: 29.0
Sex: F
Vaccine: HEPAB, IPV, MMR, TDAP, VARCEL
Symptoms: Body temperature increased, Dyspnoea, Erythema, Hypersomnia, Peripheral swelling
Clinical narrative: Left arm: red, hot, swollen, tender - Hives around back side of arm. - Labored breathing - sleeping lots. Temp 101.0 (orally) (never before immunized as stated by patient)
Age: 29.0
Sex: F
Vaccine: HEPAB, IPV, MMR, TDAP, VARCEL
Symptoms: Skin warm, Urticaria
Clinical narrative: Left arm: red, hot, swollen, tender - Hives around back side of arm. - Labored breathing - sleeping lots. Temp 101.0 (orally) (never before immunized as stated by patient)
Age: 0.17
Sex: M
Vaccine: RV5
Symptoms: Diarrhoea, Gastrooesophageal reflux disease
Clinical narrative: This spontaneous report as received from a Licensed Vocational Nurse refers to an 8 week old male patient. The patient's medical history included reflux. No drug reactions or allergies reported. On 21-APR-2015, the patient was vaccinated with the first dose of ROTATEQ (lot#07Jun2016; exp date: 07-JUN-2016) oral suspension 2ml. Concomitant therapy included PREVACID. On 21-APR-2015, the patient was diagnosed with reflux. The nurse was unsure if the patient developed the reflux prior to receiving his first dose of ROTATEQ or after. The nurse stated that the patient was prescribed ranitidine on 21-APR-2015 for the reflux. The nurse also reported that the patient was seen in the office on 22-APR-2015 due to developing diarrhea at an unspecified time after receiving his first dose of ROTATEQ. The patient sought medical attention and the physician ordered the following labs on 12-MAY-2015: stool culture, ecoli, stool occult, and other unspecified labs. The Nurse was unsure if the labs have been drawn on the patient yet. There was no intervention to prevent serious criteria and the events were reported to be not: cancer, significant disability or incapacity, hospitalization or prolongation, life threatening, overdose or PQC. The nurse reported that the patient was currently experiencing diarrhea. The outcome of the events was reported as not recovered. The relationship between the events and ROTATEQ was unknown. Additional information has been requested.
Age: 56.0
Sex: F
Vaccine: MMR
Symptoms: Arthralgia, Fatigue, Feeling abnormal, Fluid retention, Headache
Clinical narrative: Swollen lymph nodes (various locations). Extreme joint pain (various locations). Massive fluid retention. Low grade fever. Rash. Fatigue! Patient is a 56-year-old female. About two weeks ago she got an MMR vaccine and has not felt the best ever since but in the last few days she has noticed lymph nodes in the back of her neck being very swollen. She does admit that she has difficulty taking vaccines and she has been this way for a while. She states she always reacts strongly to them and in fact once before did have lymph node involvement with a prior vaccine although that was not an MMR vaccine. I believe it was a tetanus vaccine. She has no sore throat, no fever that she aware of. No nausea or vomiting or other symptoms mainly joint achiness and then these lymph nodes on the back of her neck somewhat associated with a little bit of a headache. Her past medical history is significant for osteoporosis, hypertension, GERD, fibromyalgia, and tobacco use. She is allergic to penicillin. Her current medicines are EVISTA per chart. Patient is a 56-year-old female that presents to the ER with complaints of left knee pain. She states that she woke up around 1:30 this morning and had pain into her left knee. She took 600 mg of ibuprofen around 2:30 and didn't have relief, so she decided to come to the ER to be evaluated. She believes this is all related to the MMR vaccine that she had on April 8th. On Monday she was with some coworkers eating lunch when she noticed that she had these lumps on the back of her head. She was then seen in clinic that next day by nurse practitioner who gave her ROCEPHIN, 1 gram IM. She states that her lymph nodes are still enlarged at the back of her head and also now into her neck. Now she has just had this sudden onset of left knee pain without knee injury. She believes they are all related and is concerned and wants to have it evaluated.
Age: 56.0
Sex: F
Vaccine: MMR
Symptoms: Lymphadenopathy, Mass, Pyrexia, Rash
Clinical narrative: Swollen lymph nodes (various locations). Extreme joint pain (various locations). Massive fluid retention. Low grade fever. Rash. Fatigue! Patient is a 56-year-old female. About two weeks ago she got an MMR vaccine and has not felt the best ever since but in the last few days she has noticed lymph nodes in the back of her neck being very swollen. She does admit that she has difficulty taking vaccines and she has been this way for a while. She states she always reacts strongly to them and in fact once before did have lymph node involvement with a prior vaccine although that was not an MMR vaccine. I believe it was a tetanus vaccine. She has no sore throat, no fever that she aware of. No nausea or vomiting or other symptoms mainly joint achiness and then these lymph nodes on the back of her neck somewhat associated with a little bit of a headache. Her past medical history is significant for osteoporosis, hypertension, GERD, fibromyalgia, and tobacco use. She is allergic to penicillin. Her current medicines are EVISTA per chart. Patient is a 56-year-old female that presents to the ER with complaints of left knee pain. She states that she woke up around 1:30 this morning and had pain into her left knee. She took 600 mg of ibuprofen around 2:30 and didn't have relief, so she decided to come to the ER to be evaluated. She believes this is all related to the MMR vaccine that she had on April 8th. On Monday she was with some coworkers eating lunch when she noticed that she had these lumps on the back of her head. She was then seen in clinic that next day by nurse practitioner who gave her ROCEPHIN, 1 gram IM. She states that her lymph nodes are still enlarged at the back of her head and also now into her neck. Now she has just had this sudden onset of left knee pain without knee injury. She believes they are all related and is concerned and wants to have it evaluated.
Age: 37.0
Sex: U
Vaccine: HPV4
Symptoms: Drug administered to patient of inappropriate age, No adverse event
Clinical narrative: This spontaneous report was received from a healthcare student refers to a 37 year old patient of unspecified gender. The patient's pertinent medical history and concurrent conditions were not provided. On an unknown date, the patient was vaccinated with the first dose of GARDASIL, 0.5 ml, intramuscular (lot number and expiration date were not provided). Concomitant therapy information was not provided. On an unknown date, the patient experienced inappropriate schedule of drug administration and no adverse event. The outcome of inappropriate schedule of drug administration and no adverse event was unknown. Additional information is not expected. The reporter did not wish to be contacted.
Sex: M
Vaccine: HPV4
Symptoms: Inappropriate schedule of drug administration, No adverse event
Clinical narrative: This spontaneous report was received from a registered nurse refers to a male patient of unknown age. No pertinent medical history was reported. On an unknown date, the patient was vaccinated with GARDASIL dose 1. 9 months ago on an unknown date approximately in 2014, the second dose was given. The patient was in the office for his third dose of GARDASIL. No adverse effects reported. Additional information has been requested.
Age: 0.51
Sex: M
Vaccine: DTAP, HEP, HIBV, PNC13, RV5
Symptoms: Urticaria
Clinical narrative: Urticaria.
Age: 47.0
Sex: F
Vaccine: TDAP
Symptoms: Induration, Mass
Clinical narrative: Golf ball size firm lump, no redness. 6 days post injection.
Age: 62.0
Sex: F
Vaccine: VARZOS
Symptoms: Extra dose administered
Clinical narrative: Patient came in outpatient walk-in and states she wants to get shingles vaccine after giving patient vaccine CMA noticed patient received in Jan 2015. (Patient has recvd 2-Zosters).
Age: 53.0
Sex: F
Vaccine: FLUX(H1N1)
Symptoms: Fundoscopy abnormal, Maculopathy, Optical coherence tomography abnormal, Retinal exudates, Retinal vascular disorder
Clinical narrative: Case number PHHY2015US058460 is an initial literature report received on 09 May 2015. The author discussed about a retrospective, multicenter, observational study which was conducted to evaluate the spectrum of retinal diseases that could demonstrate paracentral acute middle maculopathy and isolated ischemia of the intermediate and deep capillary plexus. This report refers to a 53 year old female patient. Her medical history included pseudophakia of eye. Her current conditions included hypothyroidism, hypertension and anxiety. She was vaccinated with H1N1 pandemic influenza vaccine (manufacturer and batch number: not reported) on an unknown date. Two to three days after vaccination, she had an acute onset of paracentral scotomas in the right eye (OD). At the time of baseline presentation, paracentral acute middle maculopathy lesions (isolated band like hyperreflective lesions in the middle retinal layers) were observed in the patient. Her baseline best corrected visual acuity (BCVA) was 20/50. Baseline fundus showed scattered parafoveal whitening (localized with paracentral acute middle maculopathy (PAMM)) and peripapillary cotton wool spot (CWS). Follow up spectral-domain optical coherence tomography (SD OCT) analysis of paracentral acute middle maculopathy lesions demonstrated subsequent thinning of the inner nuclear layer (retinal layer). The patient presented with a form of retinal vascular disease. Follow up BCVA was 20/50. The events outcome was not reported. The seriousness of the events was not reported, but the event was upgraded as medically significant based on the information available in the source documents. The causality of the event was not reported. The author stated that H1N1 vaccine was one of the novel retinal vascular associations leading to retinal vasculopathy and paracentral acute middle maculopathy. The author concluded the article stating that paracentral acute middle maculopathy lesions might develop in a wide spectrum of retinal vascular diseases. These were best identified with SD OCT analysis and might represent ischemia of the intermediate and deep capillary plexus. These lesions typically result in permanent thinning of the inner nuclear layer and were critical to identify in order to determine the cause of unexplained vision loss.
Age: 53.0
Sex: F
Vaccine: FLUX(H1N1)
Symptoms: Visual acuity tests abnormal, Visual field defect
Clinical narrative: Case number PHHY2015US058460 is an initial literature report received on 09 May 2015. The author discussed about a retrospective, multicenter, observational study which was conducted to evaluate the spectrum of retinal diseases that could demonstrate paracentral acute middle maculopathy and isolated ischemia of the intermediate and deep capillary plexus. This report refers to a 53 year old female patient. Her medical history included pseudophakia of eye. Her current conditions included hypothyroidism, hypertension and anxiety. She was vaccinated with H1N1 pandemic influenza vaccine (manufacturer and batch number: not reported) on an unknown date. Two to three days after vaccination, she had an acute onset of paracentral scotomas in the right eye (OD). At the time of baseline presentation, paracentral acute middle maculopathy lesions (isolated band like hyperreflective lesions in the middle retinal layers) were observed in the patient. Her baseline best corrected visual acuity (BCVA) was 20/50. Baseline fundus showed scattered parafoveal whitening (localized with paracentral acute middle maculopathy (PAMM)) and peripapillary cotton wool spot (CWS). Follow up spectral-domain optical coherence tomography (SD OCT) analysis of paracentral acute middle maculopathy lesions demonstrated subsequent thinning of the inner nuclear layer (retinal layer). The patient presented with a form of retinal vascular disease. Follow up BCVA was 20/50. The events outcome was not reported. The seriousness of the events was not reported, but the event was upgraded as medically significant based on the information available in the source documents. The causality of the event was not reported. The author stated that H1N1 vaccine was one of the novel retinal vascular associations leading to retinal vasculopathy and paracentral acute middle maculopathy. The author concluded the article stating that paracentral acute middle maculopathy lesions might develop in a wide spectrum of retinal vascular diseases. These were best identified with SD OCT analysis and might represent ischemia of the intermediate and deep capillary plexus. These lesions typically result in permanent thinning of the inner nuclear layer and were critical to identify in order to determine the cause of unexplained vision loss.
Age: 0.51
Sex: F
Vaccine: DTAPH, FLUX, RVX, DTAPIPV, FLUX, RVX
Symptoms: Food allergy, Frequent bowel movements, Hypersensitivity, Mucous stools
Clinical narrative: 4 large bumps on legs. 2 went away after 2 month. Two remain. Had mucusy stools for two months. Went from one bowel movement a day to 6. Bright butt rash. Began having allergic reactions to multiple foods in my diet through breastmilk.
Age: 0.51
Sex: F
Vaccine: DTAPH, FLUX, RVX, DTAPIPV, FLUX, RVX
Symptoms: Food allergy, Frequent bowel movements, Injection site rash, Mucous stools, Rash
Clinical narrative: 4 large bumps on legs. 2 went away after 2 month. Two remain. Had mucusy stools for two months. Went from one bowel movement a day to 6. Bright butt rash. Began having allergic reactions to multiple foods in my diet through breastmilk.
Age: 4.0
Sex: F
Vaccine: MMR, VARCEL
Symptoms: Vomiting
Clinical narrative: Woke up vomiting - vomited a few times over the course of an hour.  Broken blood vessels (?) on face.
Age: 1.91
Sex: F
Vaccine: MMR
Symptoms: Cytogenetic analysis, Generalised tonic-clonic seizure, Metabolic function test, Neurological examination
Clinical narrative: Generalized tonic clonic seizure.
Age: 20.0
Sex: F
Vaccine: MMR
Symptoms: Arthralgia, Headache, Hypersomnia, Pyrexia, Rash
Clinical narrative: Severe joint pain, fever, rash, horrible headache, and slept for 17 straight hours.
Age: 14.0
Sex: M
Vaccine: HPV4
Symptoms: Dyspnoea, Injection site swelling, Insomnia
Clinical narrative: Parent reported swelling "2X larger" at injection site, SOB in the evening and "unable to sleep that night".
Age: 46.0
Sex: F
Vaccine: HEP
Symptoms: Pruritus generalised, Rash
Clinical narrative: Hep B shot given at 11:00 AM. Pt reports at 5:00 PM-itching all over her body and even in throat, rash on her hairline. Took BENADRYL which has improved.
Age: 20.0
Sex: F
Vaccine: VARCEL
Symptoms: Burning sensation, Injection site reaction, Local reaction, Pruritus, Rash
Clinical narrative: Pt presented to the clinic for evaluation of a localized reaction to the varicella vaccination which she recd 5/8/15. She reported 3 hours after the immunization she noted a "small rash" to the area, when she woke up the next day she c/o warmth and itching to the area. She stated on 5/11/15 her skin at injection site felt like it was "on fire". Pt advised to take BENADRYL, PRN, NEOSPORIN 3x day to site and stop scratching area.
Age: 20.0
Sex: F
Vaccine: VARCEL
Symptoms: Skin warm
Clinical narrative: Pt presented to the clinic for evaluation of a localized reaction to the varicella vaccination which she recd 5/8/15. She reported 3 hours after the immunization she noted a "small rash" to the area, when she woke up the next day she c/o warmth and itching to the area. She stated on 5/11/15 her skin at injection site felt like it was "on fire". Pt advised to take BENADRYL, PRN, NEOSPORIN 3x day to site and stop scratching area.
Age: 53.0
Sex: F
Vaccine: VARZOS
Symptoms: Erythema, Induration, Pain, Skin discolouration, Skin warm
Clinical narrative: Warm and red the evening of the administration (subcutaneously) painful to touch. Swelling "the size of a baseball", very hard, turned black and blue. Phone calls 5/3 and 5/14 to follow up.
Age: 53.0
Sex: F
Vaccine: VARZOS
Symptoms: Swelling
Clinical narrative: Warm and red the evening of the administration (subcutaneously) painful to touch. Swelling "the size of a baseball", very hard, turned black and blue. Phone calls 5/3 and 5/14 to follow up.
Age: 82.0
Sex: F
Vaccine: PNC13
Symptoms: Chills, Injection site erythema, Pyrexia, Vaccination site oedema, Vaccination site swelling
Clinical narrative: Swelling, redness and edema at vaccine site. Possible secondary cellulitis on Thursday, 4/30/15 after vaccine between 1:10 pm and 2 pm. At 7 pm, I had chills so bad, like shaking to have to hold onto any objects, had fever of 102 next day all day.
Age: 57.0
Sex: F
Vaccine: HEP
Symptoms: Eye swelling, Swelling face, Throat tightness
Clinical narrative: This case was reported by a consumer and described the occurrence of eye swelling in a 58-year-old female patient who received (ENGERIX B ADULT (batch number 3FZ74, expiry date unknown). Concurrent medical conditions included drug allergy (causes vomiting). Concomitant products included CRESTOR and LASIX. On 14th May 2015, the patient received the 2nd dose of ENGERIX B ADULT (intramuscular) 1 ml. On 14th May 2015, 2 hrs after receiving ENGERIX B ADULT, the patient experienced eye swelling, throat constriction and facial swelling. The patient was treated with BENADRYL and prednisone. On an unknown date, the outcome of the eye swelling was not recovered/not resolved and the outcome of the throat constriction and facial swelling were recovered/resolved. It was unknown if the reporter considered the eye swelling, throat constriction and facial swelling to be related to ENGERIX B ADULT. Additional information provided: The patient reported that she went to the emergency room on 14 May 2015, she was treated and discharged home. On 15 May 2015, she experienced eye swelling again and was prescribed BENADRYL and prednisone. The patient planned to continue follow-up with her physician.
Age: 67.0
Sex: F
Vaccine: VARZOS
Symptoms: Erythema, Induration, Peripheral swelling
Clinical narrative: Red, raised, indurated area behing left arm.
Age: 66.0
Sex: F
Vaccine: PNC13
Symptoms: Rash
Clinical narrative: Developing rash. Continued to grow ea day. Used cortisone cream at site. Went to doctor's. Was measured by other Dr. Lasted aprx. 12 - 14 days.
Age: 29.0
Sex: F
Vaccine: FLU4
Symptoms: Hypoaesthesia, Neuralgia
Clinical narrative: The flu shot caused nerve pain and numbness, which lasted for weeks afterward.
Age: 63.0
Sex: M
Vaccine: VARZOS
Symptoms: Acne, Injection site erythema, Injection site reaction
Clinical narrative: Pt had an injection site reaction develop 5 days after injection.  There was a red, pimple type looking bump about 3mm in diameter at the site of injection.
Age: 47.0
Sex: M
Vaccine: TD
Symptoms: Injection site pain
Clinical narrative: Soreness at injection site of right deltoid.
Age: 65.0
Sex: M
Vaccine: VARZOS
Symptoms: Injection site erythema, Injection site pain, Injection site swelling, Rash, Swelling
Clinical narrative: Patient had an injection site reaction developing 2 days after injection.  It is a red, raised area about 1 inch in diameter surrounded by a lighter pink, non-inflamed area covering a larger portion of her arm. Patient also reports the area being tender.
Age: 17.0
Sex: F
Vaccine: FLUN4, HEPA, MNQ, TDAP, VARCEL
Symptoms: Injection site erythema, Injection site swelling
Clinical narrative: Patient received vaccines 4/27/15 approx. 4:30 PM. She went to the school nurse yesterday and was advised to call the Health Dept. The back of her (R) arm is swollen "4 inches long" with a depth of 1/2 to 1 inch. It was red and puffy. After ADVIL and a cold compress, she was feeling better.
Age: 3.0
Sex: M
Vaccine: DTAP
Symptoms: Injection site erythema, Injection site induration, Injection site pain, Injection site swelling
Clinical narrative: 3 inch swollen raised circle at shot site; stayed hard and red for 10 days; remained painful to touch; slowly decreased in size but did stay hard on surface of leg for 15 days!
Age: 42.0
Sex: F
Vaccine: HEPA, TYP
Symptoms: Chills, Headache, Nausea, Pain, Pyrexia
Clinical narrative: Started with moderate headache. By 5/17/15 severe headache and 101 fever. 5/18/15 severe headache and 101 fever, chills, body aches. Responsive to Tylenol. 5/19/15 fever 103.8, not responsive to Tylenol, body aches, severe headache, nausea, chills.
Age: 89.0
Sex: M
Vaccine: PNC13
Symptoms: Chest X-ray, Chronic obstructive pulmonary disease, Condition aggravated, Ischaemia, Laboratory test
Clinical narrative: Hospital admission. Community acquired pneumonia. Acute COPD exacerbation. Demand ischemia. To skilled nursing after hospital.
Age: 89.0
Sex: M
Vaccine: PNC13
Symptoms: Pneumonia
Clinical narrative: Hospital admission. Community acquired pneumonia. Acute COPD exacerbation. Demand ischemia. To skilled nursing after hospital.
Age: 77.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site discolouration, Injection site pruritus
Clinical narrative: Pt was itchy at injection site following vaccine, then developed baseball size discoloring at injection site (different shade of beige).
Age: 0.36
Sex: F
Vaccine: DTAPHEPBIP, HIBV, PNC13, RV1
Symptoms: Computerised tomogram head normal, Seizure like phenomena, Tonic clonic movements, Urine analysis normal
Clinical narrative: Taken to hospital when custodial great grandmother observed tonic-clonic movements. Baby was in crib. Immunizations were given 11 hours before seizure-like movements.
Age: 81.0
Sex: F
Vaccine: PNC13
Symptoms: Erythema, Induration, Pruritus, Skin reaction
Clinical narrative: Local skin reaction - red, approx 4 cm, round, mildly indurated, itchy. Tx - compress, TYLENOL, steroid lotion for itch. Return if worsening.
Age: 82.0
Sex: F
Vaccine: PNC13
Symptoms: Chest X-ray abnormal, Pneumonia
Clinical narrative: CXR positive fro bilateral pneumonia 5/15/15.
Age: 59.0
Sex: F
Vaccine: HEPAB
Symptoms: Papule, Rash
Clinical narrative: Rash. Tiny papules around eyelid, other parts of face. Resolving.