chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 5.0
Sex: F
Vaccine: DTAPIPV, MMRV
Symptoms: Swelling
Clinical narrative: Mom stated that pt had developed blister on 8-14-14 with redness or swelling and didn't feel good all day. On 8-15-14 Mom brought pt into clinic and right upper arm was red with quarter size blister that had popped and several smaller blisters next to it. Mom said pt did feel better and that arm looked much better on 8-15-14.
Age: 18.0
Sex: F
Vaccine: HPV4, MNQ
Symptoms: Abdominal pain, Dizziness, Feeling cold, Hyperaesthesia, Nausea
Clinical narrative: Sx: Freezing, skin sensitive, nausea, no vomiting and pain, dizzziness. Tx: ADVIL for symptoms relief.
Age: 75.0
Sex: M
Vaccine: FLU3
Symptoms: Injection site erythema, Injection site swelling, Musculoskeletal stiffness
Clinical narrative: Pt says after a few hours after receiving shot, he noticed stiffness in arm at injection site. Next morning he developed redness and swelling around the area. Pt took antihistamines and anti-inflammatories for next 3 days that helped reduce symptoms.
Sex: F
Vaccine: HPV4, MNQ, TDAP
Symptoms: Erythema, Swelling
Clinical narrative: Raised red area measuring 6-7 cm.
Age: 11.0
Sex: F
Vaccine: HPV4, TDAP
Symptoms: Immediate post-injection reaction, Syncope
Clinical narrative: 1430 Administered GARDASIL IM to LA then pt immediately received Tdap IM to RA at which time pt had syncopal episode. Syncopal episode lasted approx 1 min; able to arouse pt with verbal stimulation. Assisted pt to bed and juice given. VS B/P 106/60 P 90 R 16 T 97 degrees O2 Sat 95% RA. MOC denies any medical conditions or hx adverse reaction with prior vaccinations. After 30 min. pt reports feeling - ok; denies any vertigo, lightheadedness. VIS given for HPV and Tdap. Instructed to go to ER with any acute changes; MOC verbalized understanding.
Age: 2.0
Sex: F
Vaccine: HEPA, HIBV, PNC13
Symptoms: Rash
Clinical narrative: Rash on chest and back x2-3 days. Raised bumps. No fever, not itching, no diarrhea, no SOB.
Age: 76.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site erythema, Injection site haemorrhage, Injection site pruritus, Injection site warmth
Clinical narrative: Bleeding occurred at injection site at time of injection, but stopped in timely manner. Around 3 pm on 8/12, pt found inj site to be warm, itchy and red. By 8/13 had spread to area of about 3- inches in diameter. By 8/14 had subsided and was returning to normal.
Sex: F
Vaccine: VARZOS
Symptoms: Incorrect route of drug administration, Injection site erythema, Injection site irritation, Injection site reaction, Skin exfoliation
Clinical narrative: This spontaneous report was received from a field representative who was informed by a physician of a female patient of an unknown age. On an unknown date the patient was vaccinated with ZOSTAVAX for the prevention of shingles. Past medical history and concomitant medications were not reported. "About a year ago the patient (demographics unknown) received ZOSTAVAX and has been experiencing flair ups at the injection site, it is a dermatitis like scalpy spot that becomes red and irritated." The representative also reported, "judging from the injection site which is on the backside of the deltoid, the ZOSTAVAX may have been administered intramuscularly and not subcutaneous." The adverse events were treated with an unspecified cream. The outcome of the patient has been experiencing flair ups at the injection site, the ZOSTAVAX may have been administered intramuscularly and not subcutaneous and a dermatitis like scaly spot that becomes red and irritated was reported as not recovered/not resolved. The reporter considered the ZOSTAVAX may have been administered intramuscularly and not subcutaneous to be not related to ZOSTAVAX. No further adverse event information was provided. Additional information has been requested.
Sex: U
Vaccine: HPV4
Symptoms: Incorrect storage of drug, No adverse event
Clinical narrative: This spontaneous report as received from a nurse practitioner refers to a patient of unknown age and gender. Medical history and concurrent conditions were not reported. On 06-AUG-2014, the patient was vaccinated with GARDASIL, 0.5 ml, intramuscular, that was improperly stored exposed to 8.1c for one hour. Dose, lot number and expiration date were not reported. Additional information has been requested.
Age: 0.21
Sex: F
Vaccine: DTAPHEPBIP, HEP, PPV, RV5
Symptoms: Wrong drug administered
Clinical narrative: None reported. (Incorrect vaccines given).
Age: 1.0
Sex: F
Vaccine: HEPA, VARCEL, HEPA, PNC13, VARCEL
Symptoms: Blister, Irritability, Rash, Scab, Skin disorder
Clinical narrative: This spontaneous report as received from a Registered Nurse refers to a 1 year old female patient. On 16-AUG-2014 the patient was vaccinated with (Oka/Merck) VARIVAX (Lot # K002920 Exp Date: 26-FEB-2016), 0.5 ml, subcutaneous for routine immunization. Other suspect therapies included On 16-AUG-2014, PREVNAR (dose and route not provided), on 16-AUG-2014 tuberculin purified protein derivative (dose, frequency and indication not provided) and VAQTA (dose and route not provided). The nurse reported that the patient's mother called into the office on 18-AUG-2014, the child developed more bumps on her legs, mainly on the backside. The mother said they were blister like spots and some had scabbed over, the child was irritable and grasping at her legs like they were itching. The patient was seen in the office on 18-AUG-2014, and the nurse reported an unspecified physician stated it looks like a possible reaction to varicella. The nurse stated the patient's mother gave the child TYLENOL for treatment on 18-AUG-2014. Lab test was not performed. No further information was provided. The outcome of adverse reactions was reported as not recovered/not resolved. Relatedness between adverse reactions and (Oka/Merck) VARIVAX, PREVNAR, tuberculin purified protein derivative and VAQTA was unknown. Additional information has been requested.
Age: 1.0
Sex: F
Vaccine: HEPA, VARCEL, HEPA, PNC13, VARCEL
Symptoms: Blister, Erythema, Injection site rash, Pruritus, Rash
Clinical narrative: This spontaneous report as received from a Registered Nurse refers to a 1 year old female patient. On 16-AUG-2014 the patient was vaccinated with (Oka/Merck) VARIVAX (Lot # K002920 Exp Date: 26-FEB-2016), 0.5 ml, subcutaneous for routine immunization. Other suspect therapies included On 16-AUG-2014, PREVNAR (dose and route not provided), on 16-AUG-2014 tuberculin purified protein derivative (dose, frequency and indication not provided) and VAQTA (dose and route not provided). The nurse reported that the patient's mother called into the office on 18-AUG-2014, the child developed more bumps on her legs, mainly on the backside. The mother said they were blister like spots and some had scabbed over, the child was irritable and grasping at her legs like they were itching. The patient was seen in the office on 18-AUG-2014, and the nurse reported an unspecified physician stated it looks like a possible reaction to varicella. The nurse stated the patient's mother gave the child TYLENOL for treatment on 18-AUG-2014. Lab test was not performed. No further information was provided. The outcome of adverse reactions was reported as not recovered/not resolved. Relatedness between adverse reactions and (Oka/Merck) VARIVAX, PREVNAR, tuberculin purified protein derivative and VAQTA was unknown. Additional information has been requested.
Age: 1.0
Sex: F
Vaccine: HEPA, VARCEL, HEPA, PNC13, VARCEL
Symptoms: Rash vesicular, Scab
Clinical narrative: This spontaneous report as received from a Registered Nurse refers to a 1 year old female patient. On 16-AUG-2014 the patient was vaccinated with (Oka/Merck) VARIVAX (Lot # K002920 Exp Date: 26-FEB-2016), 0.5 ml, subcutaneous for routine immunization. Other suspect therapies included On 16-AUG-2014, PREVNAR (dose and route not provided), on 16-AUG-2014 tuberculin purified protein derivative (dose, frequency and indication not provided) and VAQTA (dose and route not provided). The nurse reported that the patient's mother called into the office on 18-AUG-2014, the child developed more bumps on her legs, mainly on the backside. The mother said they were blister like spots and some had scabbed over, the child was irritable and grasping at her legs like they were itching. The patient was seen in the office on 18-AUG-2014, and the nurse reported an unspecified physician stated it looks like a possible reaction to varicella. The nurse stated the patient's mother gave the child TYLENOL for treatment on 18-AUG-2014. Lab test was not performed. No further information was provided. The outcome of adverse reactions was reported as not recovered/not resolved. Relatedness between adverse reactions and (Oka/Merck) VARIVAX, PREVNAR, tuberculin purified protein derivative and VAQTA was unknown. Additional information has been requested.
Age: 5.0
Sex: U
Vaccine: MMR, VARCEL
Symptoms: Incorrect dose administered, No adverse event
Clinical narrative: This spontaneous report as received from a healthcare worker, refers to a 5 year old child of unknown gender. The patient's pertinent medical history, drug reactions/allergies were not provided. It was reported that in 2010, patient received the first dose of M-M-R II, 0.5 ml, subcutaneously, and on the same date received the first dose of VARIVAX (Merck), (dose and route not provided) (lot numbers and expiration dates were not provided). On 02-DEC-2013, patient received the second dose of M-M-R II, 0.5 ml, subcutaneously, and the second dose of VARIVAX (Merck), (dose and route not provided) (lot numbers and expiration dates were not provided). On 13-AUG-2014, patient received the third dose of M-M-R II, 0.5 ml, subcutaneously, and the third dose of VARIVAX (Merck), (dose and route not provided) (lot numbers and expiration dates were not provided). No adverse effects were reported. Additional information is not expected since the physician cannot be contacted.
Sex: U
Vaccine: VARCEL
Symptoms: Expired drug administered, No adverse event
Clinical narrative: This spontaneous report was received from a register nurse concerning a patient of unknown age and gender. medical history and concurrent conditions were not reported. On 11-AUG-2014, the patient was vaccinated with the first dose of (Oka/Merck) VARIVAX dose and route were not reported), lot number reported as H010558, lot number reported as 24-MAY-2014. Co-suspect and concomitant therapies were not reported. The register nurse reported the patient received an expired first dose of (Oka/Merck) VARIVAX (lot # H010558 exp 24-MAY-2014) on 11-AUG-2014. No adverse symptoms reported. Additional information has been requested.
Sex: U
Vaccine: MMR
Symptoms: Expired drug administered, No adverse event
Clinical narrative: This spontaneous report as received from a medical assistant refers to a patient of unknown age and gender. Information regarding concurrent conditions and pertinent medical history was not provided. On 12-AUG-2014 the patient was vaccinated with an expired dose of MMR II (injection, lot # H013042, expiration date 17-JUL-201, dose, route, and frequency were not provided). Concomitant medications were not provided. No adverse effect was reported. Additional information is not expected.
Age: 84.0
Sex: U
Vaccine: VARCEL
Symptoms: No adverse event, Wrong drug administered
Clinical narrative: This spontaneous report was received from a physician refers to a 84 year old patient of an unknown gender. Medical history and concurrent conditions were not reported. On 13-AUG-2014, the patient was vaccinated with a dose of VARIVAX (Merck) (dose, dose number, route, lot number and expiration date were not reported). Co-suspect and concomitant therapies were not reported. The physician stated that an adult patient received VARIVAX (Merck) on 13-AUG-2014, and should have received ZOSTAVAX. No adverse effect reported. Additional information has been requested.
Sex: U
Vaccine: MMRV
Symptoms: Incorrect storage of drug, No adverse event
Clinical narrative: This spontaneous report as received from a certified medical assistant refers to 3 patients of unknown age and gender. On unknown dates the patients were vaccinated with improperly stored (Oka/Merck) PROQUAD (lot #, strength, dose, frequency and route unspecified). No adverse symptoms reported. The outcome of the events were unknown. This is one of several reports received from the same source. Additional information has been requested.
Sex: U
Vaccine: VARCEL
Symptoms: Incorrect storage of drug, No adverse event
Clinical narrative: This spontaneous report as received from a certified medical assistant refers to 2 patients of unknown age and gender. On unknown dates the patients were vaccinated with improperly stored VARIVAX (merck) (lot #, strength, dose, frequency and route unspecified). No adverse symptoms reported. The outcome of the events were unknown. This is one of several reports received from the same source. Additional information has been requested.
Sex: U
Vaccine: VARZOS
Symptoms: Incorrect storage of drug, No adverse event
Clinical narrative: This spontaneous report as received from a certified medical assistant refers to a patient of unknown age and gender. On 12-AUG-2014 the patient was vaccinated with 0.65 ml dose of ZOSTAVAX that had been stored at 39 degrees F for 14.5 hours, subcutaneous (lot#, strength, frequency unspecified). No adverse effect reported. The outcome of the event was unknown. Additional information has been requested.
Sex: U
Vaccine: MMRV
Symptoms: Incorrect storage of drug, No adverse event
Clinical narrative: This spontaneous report as received from a healthcare worker refers to a patient of unknown age and gender. Information about concurrent medical conditions, concomitant medication and medical history was not provided. On 06-AUG-2014 the patient was vaccinated with 0.5ml dose of PROQUAD (Merck) (injection, lot# and dose number were not provided), which had undergone a temperature excursion, subcutaneously. No adverse effect was reported. This is one of several reports received from the same source. Additional information has been requested.
Sex: U
Vaccine: HPV4
Symptoms: Incorrect dose administered, No adverse event
Clinical narrative: This spontaneous report as received from a registered nurse refers to a patient of unknown age and tender. The reporter stated that the patient, who received the third dose of GARDASIL on an unspecified date approximately in 2011 (reported as 2-3 years ago), on 09-AUG-2014 was inadvertently administered with the fourth dose of GARDASIL (intramuscular injection, dose 4, 0.5 ml, intramuscular, strength, anatomical location, lot # and expiration date not reported). No adverse effects reported. No further information provided. Additional information is not expected since the reporter did not consent to be contacted for further follow up.
Age: 11.0
Sex: M
Vaccine: PPV
Symptoms: Expired drug administered, No adverse event
Clinical narrative: This spontaneous report as received from a registered nurse refers to an 11 year old male patient who was being prepped for a kidney transplant. On 23-JUL-2014 the patient was vaccinated with an expired dose of PNEUMOVAX vial lot # H018608, Exp date: 02-JUL-2014, (dose, frequency and route unspecified). No adverse effect reported. Additional information has been requested.
Sex: U
Vaccine: MMR
Symptoms: Expired drug administered, No adverse event
Clinical narrative: This spontaneous report as received from a pharmacist refers to a patient of unknown age and gender. On 07-AUG- 2014 the patient was vaccinated with an expired dose of M-M-R II (lot # H014649, exp. Date 03-AUG-2014) 0.5 nl dose, subcutaneous route. Concomitant therapy was not reported. No adverse effect was reported. Additional information is not expected, since physician does not want to be contacted.
Age: 4.0
Sex: U
Vaccine: HPV4
Symptoms: Drug administered at inappropriate site, No adverse event
Clinical narrative: This spontaneous report was received from a pharmacist concerning to a 4 year old patient of an unknown gender. Medical history and concurrent conditions were not reported. On 07-Aug-2014, the patient was vaccinated with a dose of GARDASIL (dose number, lot number and expiration date were not reported), 0.5 ml, intramuscular. Co-suspect and concomitant therapies were not reported. The pharmacist reported a 4 year old patient was inadvertently administered GARDASIL on 04-AUG-2014. No adverse effects reported. Additional information has been requested.
Age: 18.0
Sex: M
Vaccine: HEP
Symptoms: Antibody test negative
Clinical narrative: This spontaneous report was received from a physician refers to an 18 year old male patient with rhinitis. There were not drug reactions or allergies. The physician reported that the patient received 3 dose series of an unspecified HepB (manufacturer unknown) injection, (lot number, expiration date, route, and dosage were not provided). RECOMBIVAX HB could not be ruled out. On 09-JAN-1996 the first dose, 27-DEC-1996, second dose, 09-JUL-1996 third dose and then another 3 dose series on an unspecified HepB (manufacturer unknown) injection, (lot number, expiration date, route, and dosage were not provided) because of negative titers. RECOMBIVAX HB. On 07-AUG-2012 the first dose, 27-DEC-2012, second dose, 27-JUN-2012 third dose. The had titers drawn on 24-MAY-2014 and they showed negative titers, they were less than 5. The patient was then administered a dose of ENGERIX-B on 02-JUN-2014. The patient had titers drawn again on 08-AUG-2014 which showed negative titers again below 5. There were not concomitant therapies or treatments given for the adverse events. At the moment of this report the outcome of the events was unknown. Additional information is not expected because the reporter refused additional contact.
Sex: U
Vaccine: MMR
Symptoms: Expired drug administered, No adverse event
Clinical narrative: This spontaneous report as received from a certified medical assistant refers to a patient of unknown age and gender. Medical history and drug reactions/allergies were not reported. On 07-AUG-2014, the patient was vaccinated with an expired M-M-R II, subcutaneously, expiry date 03-AUG-2014 (lot and dose not reported). Concomitant medications was not reported. No adverse effects reported. At the time of the report, action taken regarding therapy with M-M-R II was not reported. Additional information has been requested.
Age: 40.0
Sex: F
Vaccine: VARCEL
Symptoms: Herpes zoster
Clinical narrative: This spontaneous report as received from a nurse practitioner refers to a 40 year old female patient. Medical history and concurrent conditions were not reported. On 25-JUL-2014, the patient was vaccinated with (Oka/Merck) VARIVAX, subcutaneous, 1 single shot. Dose, lot number and expiration date were not reported. No co-suspect and concomitant therapies were reported. On 01-AUG-2014, the patient developed herpes zoster along the trunk of one side after receiving (Oka/Merck) VARIVAX. The outcome of herpes zoster was unknown. No lab diagnostics studies were performed. The event was treated with VALTREX. The patient did seek medical attention. Additional information has been requested.
Sex: M
Vaccine: VARZOS
Symptoms: Incorrect storage of drug, No adverse event
Clinical narrative: This spontaneous report was received from a physician's wife in reference to her husband (age not reported). On 24-JUL-2014 the patient was vaccinated with ZOSTAVAX, via a subcutaneous route of administration. Past medical history and concomitant medications were not reported. On 24-JUL-2014 the physician's wife stated that she administered ZOSTAVAX to her husband after it had been reconstituted and frozen for 36 hours. No adverse effects reported. The outcome of reconstituted and frozen for 36 hours and no adverse effects reported is unknown. Additional information has been requested.
Sex: M
Vaccine: PPV
Symptoms: Body temperature increased, Fatigue, Injection site erythema
Clinical narrative: This spontaneous report was received from a male patient of unknown age reporting on himself. On 01-AUG-2014 the patient was vaccinated with PNEUMOVAX 23 in the left arm (dose, route of administration and lot # were not reported). On 01-AUG-2014, 3-4 hrs after receiving the PNEUMOVAX 23 the patient became very very tired. Then for the next "two or three days after the vaccination," the patient still felt tired. In August 2014 the patient had a very large red area in the upper left arm that is about 4 to 5 inches in diameter at the injection site, and had temperature that went up to 101 F. At the time of this report the injection site reaction was becoming less red however, it was not reducing in size. Patient sought medical attention on 07-AUG-2014. The outcome of patient became very very tired was reported as not recovered/not resolved. The outcome of large area in the upper left arm that was about 4 to 5 inches in diameter at the injection site was reported as recovering/resolving. The outcome of patient had temperature that went up to 101 f was reported as recovered/resolved on 05-AUG-2014. Additional information has been requested.
Age: 10.0
Sex: F
Vaccine: FLUN4, FLUN4
Symptoms: Acute disseminated encephalomyelitis, Headache, Immunoglobulin therapy, Laboratory test abnormal, Mental status changes
Clinical narrative: Headache, neck pain, fatigue, sensitivity to light, sounds, vomiting for the next two weeks.
Age: 10.0
Sex: F
Vaccine: FLUN4, FLUN4
Symptoms: Muscular weakness, Nuclear magnetic resonance imaging brain abnormal, Pyrexia, Urinary incontinence, Vomiting
Clinical narrative: Headache, neck pain, fatigue, sensitivity to light, sounds, vomiting for the next two weeks.
Age: 10.0
Sex: F
Vaccine: FLUN4, FLUN4
Symptoms: Fatigue, Headache, Hyperacusis, Laboratory test, Lumbar puncture
Clinical narrative: Headache, neck pain, fatigue, sensitivity to light, sounds, vomiting for the next two weeks.
Age: 10.0
Sex: F
Vaccine: FLUN4, FLUN4
Symptoms: Neck pain, Photophobia, Vomiting
Clinical narrative: Headache, neck pain, fatigue, sensitivity to light, sounds, vomiting for the next two weeks.
Age: 12.0
Sex: F
Vaccine: HPV4, HPV4, HPVX, HPV4, HPV4
Symptoms: Cardio-respiratory arrest, Death
Clinical narrative: Patient reporterdly tolerated vaccination well in clinic.  Parent reported that she found patient unresponsive on floor at home at approximately 1530.  EMS reportedly found pill bottles including Adderall and Relafen; hydrocodone tablets found at scene.  Waldryl reportedly found scattered in bathroom.  Patient received CPR and was transported to ED where she died.
Age: 12.0
Sex: F
Vaccine: HPV4, HPV4, HPVX, HPV4, HPV4
Symptoms: Death, Fall, Pulse absent, Respiratory arrest, Skin warm
Clinical narrative: Patient reporterdly tolerated vaccination well in clinic.  Parent reported that she found patient unresponsive on floor at home at approximately 1530.  EMS reportedly found pill bottles including Adderall and Relafen; hydrocodone tablets found at scene.  Waldryl reportedly found scattered in bathroom.  Patient received CPR and was transported to ED where she died.
Age: 12.0
Sex: F
Vaccine: HPV4, HPV4, HPVX, HPV4, HPV4
Symptoms: Somnolence, Vomiting
Clinical narrative: Patient reporterdly tolerated vaccination well in clinic.  Parent reported that she found patient unresponsive on floor at home at approximately 1530.  EMS reportedly found pill bottles including Adderall and Relafen; hydrocodone tablets found at scene.  Waldryl reportedly found scattered in bathroom.  Patient received CPR and was transported to ED where she died.
Age: 12.0
Sex: F
Vaccine: HPV4, HPV4, HPVX, HPV4, HPV4
Symptoms: Death
Clinical narrative: Patient reporterdly tolerated vaccination well in clinic.  Parent reported that she found patient unresponsive on floor at home at approximately 1530.  EMS reportedly found pill bottles including Adderall and Relafen; hydrocodone tablets found at scene.  Waldryl reportedly found scattered in bathroom.  Patient received CPR and was transported to ED where she died.
Age: 12.0
Sex: F
Vaccine: HPV4, HPV4, HPVX, HPV4, HPV4
Symptoms: Autopsy, Death, Unresponsive to stimuli
Clinical narrative: Patient reporterdly tolerated vaccination well in clinic.  Parent reported that she found patient unresponsive on floor at home at approximately 1530.  EMS reportedly found pill bottles including Adderall and Relafen; hydrocodone tablets found at scene.  Waldryl reportedly found scattered in bathroom.  Patient received CPR and was transported to ED where she died.
Age: 12.0
Sex: F
Vaccine: HPV4, HPV4, HPVX, HPV4, HPV4
Symptoms: Death, Hypersomnia, Loss of consciousness, Resuscitation, Somnolence
Clinical narrative: Patient reporterdly tolerated vaccination well in clinic.  Parent reported that she found patient unresponsive on floor at home at approximately 1530.  EMS reportedly found pill bottles including Adderall and Relafen; hydrocodone tablets found at scene.  Waldryl reportedly found scattered in bathroom.  Patient received CPR and was transported to ED where she died.
Age: 36.0
Sex: M
Vaccine: TDAP, TDAP
Symptoms: Dizziness, Fatigue, Feeling abnormal, Gait disturbance, Malaise
Clinical narrative: Disorientation, dizziness, altered gait. Moderate fatigue basic ADL's. Lasted for 12 hours and then the basic flu like symptoms with soreness and muscle pain. Completely resolved within 48 hours.
Age: 36.0
Sex: M
Vaccine: TDAP, TDAP
Symptoms: Pyrexia, Slow speech
Clinical narrative: Disorientation, dizziness, altered gait. Moderate fatigue basic ADL's. Lasted for 12 hours and then the basic flu like symptoms with soreness and muscle pain. Completely resolved within 48 hours.
Age: 36.0
Sex: M
Vaccine: TDAP, TDAP
Symptoms: Disorientation, Dizziness, Fatigue, Gait disturbance, Influenza like illness
Clinical narrative: Disorientation, dizziness, altered gait. Moderate fatigue basic ADL's. Lasted for 12 hours and then the basic flu like symptoms with soreness and muscle pain. Completely resolved within 48 hours.
Age: 36.0
Sex: M
Vaccine: TDAP, TDAP
Symptoms: Myalgia, Pain
Clinical narrative: Disorientation, dizziness, altered gait. Moderate fatigue basic ADL's. Lasted for 12 hours and then the basic flu like symptoms with soreness and muscle pain. Completely resolved within 48 hours.
Age: 55.0
Sex: M
Vaccine: VARZOS
Symptoms: Pain, Rash, Urine analysis
Clinical narrative: Pain lower right side, later followed by a rash.
Age: 40.0
Sex: F
Vaccine: TDAP
Symptoms: Back pain, Injection site pain
Clinical narrative: Intermittent pain from R upper arm radiating to R upper back using Motrin states no relief, no neuro, circulatory or muscular deficit.
Age: 1.25
Sex: F
Vaccine: DTAP, HIBV, MMR
Symptoms: Convulsion, Crying, Dyskinesia, Pyrexia, Screaming
Clinical narrative: Woke to daughter screaming/crying oddly. Viewed on monitor child jerking. Entered room - child actively seizing. Total time 1-2 min. Observed. Ambulance called. Child unresponsive, taken to ER. Fever 102.4. (+) UTI.
Age: 1.25
Sex: F
Vaccine: DTAP, HIBV, MMR
Symptoms: Unresponsive to stimuli, Urinary tract infection
Clinical narrative: Woke to daughter screaming/crying oddly. Viewed on monitor child jerking. Entered room - child actively seizing. Total time 1-2 min. Observed. Ambulance called. Child unresponsive, taken to ER. Fever 102.4. (+) UTI.
Age: 12.0
Sex: M
Vaccine: HPV4, MNQ, TDAP, VARCEL
Symptoms: Induration, Injection site erythema, Injection site swelling, Injection site vesicles
Clinical narrative: Area where Varivax was administered became very red and swollen on 8/13 per mother. Child was seen by physician on 8/14/14. Physician noted "14 cm erythema upper arm with several vesicles." Quarter size area of induration noted. Mother had been administering ibuprofen and acetaminophen and applying cold compresses. Recommended Bendadryl and Ibuprofen. Later in the afternoon on 8/14 mother reported red area had gotten larger. 8/15 red area started going down and by st 8/16 red area was completely gone and child recovered.
Age: 63.0
Sex: F
Vaccine: PPV
Symptoms: Body temperature increased, Dyspnoea, Type III immune complex mediated reaction
Clinical narrative: Arthus reaction to PPSV23 injection. SOB, temp at 101 down to 99 on 8/20/14. Two extra strength Tylenol and two OTC ibuprofen to treat fever. Best if body fights the reaction. Problem was administration: Medical assistant came into room with uncapped needles for myself and mother. She administered the vaccine so fast before I could realize that she did not swab the area prior to administering vaccine.  Reported to clinic the issue but they did not offer to see me.
Age: 1.06
Sex: F
Vaccine: HEPA, VARCEL, HEPA, PNC13, VARCEL
Symptoms: Blister, Irritability, Rash, Scab, Skin disorder
Clinical narrative: Pt. received VARIVAX at about 10:30 am. On 8/16/14. On 8/16/14 at about 830 p.m. mom reported small raised bumps in axillary area and one spot on back. 8/17/14 - a.m. mom noticed multiple more "spots" on both legs. Mom described spots as red blisters with one or two that "crusted" over. Mom also reported she felt pt. was bothered by spots -> itchy. Pt. seen in office 8/18/14 dx with varicella like lesions. Symptomatic tx only at this time.
Age: 1.06
Sex: F
Vaccine: HEPA, VARCEL, HEPA, PNC13, VARCEL
Symptoms: Blister, Erythema, Injection site rash, Pruritus, Rash
Clinical narrative: Pt. received VARIVAX at about 10:30 am. On 8/16/14. On 8/16/14 at about 830 p.m. mom reported small raised bumps in axillary area and one spot on back. 8/17/14 - a.m. mom noticed multiple more "spots" on both legs. Mom described spots as red blisters with one or two that "crusted" over. Mom also reported she felt pt. was bothered by spots -> itchy. Pt. seen in office 8/18/14 dx with varicella like lesions. Symptomatic tx only at this time.
Age: 1.06
Sex: F
Vaccine: HEPA, VARCEL, HEPA, PNC13, VARCEL
Symptoms: Rash vesicular, Scab
Clinical narrative: Pt. received VARIVAX at about 10:30 am. On 8/16/14. On 8/16/14 at about 830 p.m. mom reported small raised bumps in axillary area and one spot on back. 8/17/14 - a.m. mom noticed multiple more "spots" on both legs. Mom described spots as red blisters with one or two that "crusted" over. Mom also reported she felt pt. was bothered by spots -> itchy. Pt. seen in office 8/18/14 dx with varicella like lesions. Symptomatic tx only at this time.
Age: 4.0
Sex: M
Vaccine: DTAPIPV
Symptoms: Injection site pain, Injection site swelling
Clinical narrative: Swelling of the arm with pain.
Age: 1.07
Sex: U
Vaccine: MMR
Symptoms: Incorrect storage of drug, No adverse event
Clinical narrative: This spontaneous report as received from a registered nurse refers to a 12 months old patient of unknown gender. On 08-MAY-2014 the patient was vaccinated with M-M-R II (therapy type: rHA, batch number: J005846, lot: 1681AA, expiry date: 17-APR-2014) that on 03/03/2014 was exposed at an unsupported temperature excursion temperature range 45F, time frame: 24h). No adverse effect ws reported. This is one of several reports received from the same reporter. Additional information has been requested.
Sex: U
Vaccine: VARZOS
Symptoms: Expired drug administered, No adverse event
Clinical narrative: This spontaneous report as received from a healthcare worker refers to a patient of unknown age and gender. Concomitant medications and pertinent medical history were not provided. On 08-AUG-2014 the patient was vaccinated with ZOSTAVAX (lot #, dose, route and frequency were not provided), which was expired on 30-APR-2014. No adverse effect was reported. N product quality complaint (PQC). Additional information is not expected.
Sex: U
Vaccine: HPV4
Symptoms: Incorrect storage of drug, No adverse event
Clinical narrative: This spontaneous report as received from a registered nurse refers to an unknown number of patients of unknown age and gender. The reporter stated that since May 2014 (exact date unspecified) an unknown number of patients had received doses of GARDASIL (dosage details, route, lot# and expiration date were not reported) which underwent temperatures which fell outside the prescribing information. Among these improperly stored GARDASIL vaccines were these that were supported and these that were not supported. No adverse events were reported. No PQC (product quality complaint) was involved. This is the one of several reports received from the same reporter. Additional information has been requested.
Age: 0.17
Sex: M
Vaccine: DTAPIPVHIB, PNC13, RV1, DTAPIPVHIB, PNC13, RV1
Symptoms: Diarrhoea
Clinical narrative: 2 month old male developed diarrhea of 10 stools a day starting one day after receiving ROTARIX. No fever but some irritability. He also received PENTACEL and PCV13 infectious. No vomiting, no sick contacts, not dehydrated.
Age: 0.17
Sex: M
Vaccine: DTAPIPVHIB, PNC13, RV1, DTAPIPVHIB, PNC13, RV1
Symptoms: Diarrhoea, Irritability
Clinical narrative: 2 month old male developed diarrhea of 10 stools a day starting one day after receiving ROTARIX. No fever but some irritability. He also received PENTACEL and PCV13 infectious. No vomiting, no sick contacts, not dehydrated.
Sex: U
Vaccine: MMR
Symptoms: Incorrect storage of drug, No adverse event
Clinical narrative: This spontaneous report as received from a registered nurse refers to an unknown number of patients of unknown age and gender. The reporter stated that since May 2014 (exact date unspecified) an unknown number of patients had received doses of M-M-R II (therapy type, dosage details, route, lot# and expiration date were not reported) which underwent temperatures which fell outside the prescribing information and which were supported. No adverse events were reported. No PQC (product quality complaint) was involved. This is the one of several reports received from the same reporter. Additional information has been requested.
Sex: F
Vaccine: VARZOS
Symptoms: Injection site erythema, Injection site swelling
Clinical narrative: This spontaneous report as received from a non pregnant female physician of an unknown age via company representative reporting on herself. On an unknown date the patient was vaccinated with ZOSTAVAX, dose 0.65ml, subcutaneous (lot number and expiration date not reported). On an unknown date the patient experienced redness and swelling at the injection site after receiving ZOSTAVAX. At the time of the report the outcome of the events was reported as recovered. It was unknown if the patient sought medical attention.  Additional information has been requested.
Age: 50.0
Sex: M
Vaccine: MMR
Symptoms: Expired drug administered, No adverse event
Clinical narrative: This spontaneous report as received from a certified medical assistant refers to a 50 year old male patient. No information on his medical history, concurrent conditions or concomitant drugs were provided. On 18-AUG-2014 the patient was a vaccinated with an expired dose of M-M-R II, 0.5ml, subcutaneously; lot# H014991, expiration date 10-AUG-2014, albumin status HSA, (dose number and site of injection not reported. No adverse events were noted. The patient did not seek medical attention. Additional information has been requested.
Age: 68.0
Sex: F
Vaccine: PPV
Symptoms: Asthenia, Blood test, Chills, Dizziness, Feeling abnormal
Clinical narrative: This spontaneous report ws received from a 68 year old female patient regarding herself. The patient was allergic to chromium diphosphate. The patient's pertinent medical history included bronchitis which occurred in Autumn of 2013. The patient was not a pregnant. On 14-AUG-2014 the patient was vaccinated with PNEUMVAX23. (Dose/Frequency: 0.5ml/single dose) (lot # K005957, expiry date: 08-MAR-2015) subcutaneously to avoid recurrence of bronchitis. Concomitant therapies included TENORMIN 50 mg, LIPITOR 10 mg, CITRACL +D 630 mg and BIOTIN 10,000 microgram. On 15-AUG-2014, the patient experienced vomiting, nausea, dizziness, weakness, light headedness, chills, feeling not herself and pain when moving her arm in the location where the PNEUMOVAX23 was injected. The patient reported that the pain in the arm occurred directly after vaccination but went away shortly after. The lab tests performed included blood work but the results were not reported. The patient sought medication attention, contacted the physician but was unable to reach her and no treatment was provided for the events. The outcome of nausea, feeling not herself, chills, light headedness, weakness and dizziness was reported as recovering. The outcome of  vomiting was reported as recovered on 17-AUG-2014 and pain when moving her arm in the location where PNEUMOVAX23 was injected ws reported as recovered. The causality of vomiting, nausea, dizziness, weakness, light headedness, chills,feeling not herself and pain when moving her arm in the location where PNEUMOVAX23 was injection was not provided. No product quality complaint (PQC) was reported for PNEUMOVAX23. Additional information has been requested.
Age: 68.0
Sex: F
Vaccine: PPV
Symptoms: Immediate post-injection reaction, Injection site pain, Nausea, Pain, Vomiting
Clinical narrative: This spontaneous report ws received from a 68 year old female patient regarding herself. The patient was allergic to chromium diphosphate. The patient's pertinent medical history included bronchitis which occurred in Autumn of 2013. The patient was not a pregnant. On 14-AUG-2014 the patient was vaccinated with PNEUMVAX23. (Dose/Frequency: 0.5ml/single dose) (lot # K005957, expiry date: 08-MAR-2015) subcutaneously to avoid recurrence of bronchitis. Concomitant therapies included TENORMIN 50 mg, LIPITOR 10 mg, CITRACL +D 630 mg and BIOTIN 10,000 microgram. On 15-AUG-2014, the patient experienced vomiting, nausea, dizziness, weakness, light headedness, chills, feeling not herself and pain when moving her arm in the location where the PNEUMOVAX23 was injected. The patient reported that the pain in the arm occurred directly after vaccination but went away shortly after. The lab tests performed included blood work but the results were not reported. The patient sought medication attention, contacted the physician but was unable to reach her and no treatment was provided for the events. The outcome of nausea, feeling not herself, chills, light headedness, weakness and dizziness was reported as recovering. The outcome of  vomiting was reported as recovered on 17-AUG-2014 and pain when moving her arm in the location where PNEUMOVAX23 was injected ws reported as recovered. The causality of vomiting, nausea, dizziness, weakness, light headedness, chills,feeling not herself and pain when moving her arm in the location where PNEUMOVAX23 was injection was not provided. No product quality complaint (PQC) was reported for PNEUMOVAX23. Additional information has been requested.
Age: 1.02
Sex: U
Vaccine: VARCEL
Symptoms: Incorrect storage of drug, No adverse event
Clinical narrative: This spontaneous report was received from a healthcare worker (also reported as office manager) refers to multiple unspecified patients of unknown demographics. No relevant medical history of the patients was reported. On unspecified dates the multiple unspecified patients were vaccinated with (Oka/Merck) VARIVAX (strength, dose, route, site of administration and lot number were not reported). There were no concomitant medications reported. It was reported that the multiple unspecified patients were administered with (Oka/Merck) VARIVAX that was stored improperly on unknown dates. There were no adverse effects reported.  It was  unspecified whether the patients had sought any medical attention. There was no product quality complaint involved.   Follow up information has been received from office manager, who stated she may call back for fax information as it become available. Also, reported that M-M-R II was not mentioned in the original call, but did experience a temperature excursion. No further information was available at that time.   Follow up information as received from a  healthcare processional refers to a 12 months old patient. On 25-JUN-2014 the patient ws vaccinated with a dose of improperly stored (Oka/Merck) VARIVAX (lot # J013907, expiration date 30-OCT-2015) (strength, dose, route and site of administration were not reported). This is one of the several reports from the same source.  Additional information has been requested.
Sex: U
Vaccine: PPV
Symptoms: Expired drug administered, No adverse event
Clinical narrative: This spontaneous report as received from a pharmacist refers to a patient of unknown age and gender. Information regarding concurrent conditions and pertinent medical history was not provided. On 12-AUG-2014 the patient was vaccinated with an expired dose of PNEUMOVAX23 (injection, lot # J009827, expiration date 10-AUG-2014, 0.5 ml, frequency was not provided) intramuscular. Concomitant medications were not provided. No adverse effect as reported. Additional information has been requested.
Age: 1.29
Sex: U
Vaccine: VARCEL
Symptoms: Incorrect storage of drug, No adverse event
Clinical narrative: This spontaneous report was received from a healthcare worker (also reported as office manager) refers to multiple unspecified patients of unknown demographics. No relevant medical history of the patients was reported. On unspecified dates the multiple unspecified patients were vaccinated with (Oka/Merck) VARIVAX (strength, dose, route, site of administration and lot number were not reported). There were no concomitant medications reported. It was reported that the multiple unspecified patients were administered with (Oka/Merck) VARIVAX that was stored improperly on unknown dates. There were no adverse effects reported.  It was  unspecified whether the patients had sought any medical attention. There was no product quality complaint involved.   Follow up information has been received from office manager, who stated she may call back for fax information as it become available. Also, reported that M-M-R II was not mentioned in the original call, but did experience a temperature excursion. No further information was available at that time.   Follow up information as received from a  healthcare processional refers to a 15 months old patient. On 25-JUN-2014 the patient ws vaccinated with a dose of improperly stored (Oka/Merck) VARIVAX (lot # J013907, expiration date 30-OCT-2015) (strength, dose, route and site of administration were not reported). This is one of the several reports from the same source.  Additional information has been requested.
Sex: U
Vaccine: VARCEL
Symptoms: Incorrect storage of drug, No adverse event
Clinical narrative: This spontaneous report ws received from a nurse regarding unknown number of patients of unknown age and gender. There was no information on pertinent medical history and drug reactions or allergies. Since 02-JUN-2014, unknown number of patients were vaccinated with (Oka/Merck) VARIVAX (dose, product lot, expiry date not reported) subcutaneously, which was improperly stored. This was supported. No adverse effects reported. There was no product quality complaint involved. The outcome of the event was unknown. Additional information has been requested.
Sex: U
Vaccine: RV5
Symptoms: Expired drug administered, No adverse event
Clinical narrative: This spontaneous report as received from a nurse refers to a patient of unknown age. The nurse reported that ROTATEQ (lot ws not reported) which expired 09-JUL-2014 ws given to a patient on 07-AUG-2014. No adverse effects reported. Additional information has been requested.
Age: 0.29
Sex: U
Vaccine: RV5
Symptoms: Incorrect storage of drug, No adverse event
Clinical narrative: This spontaneous report as received from a medical assistant refers to an unspecified number of patients of unknown age and gender. Medical history and drug reactions or allergies were not specified. On unknown dates in 2014, reported as from 10-JUN-2014 to 18-JUL-2014, an unspecified number of patients were vaccinated with doses of ROTATEQ orally, (dose number, dose and lot number were not reported), which were improperly stored. No adverse events were reported. Concomitant medications were not specified. The action taken and outcome were not provided. Follow up information was received from the medical assistant on 06-AUG-2014. The medical assistant stated the temperature excursions occurred on two different dates: 10-JUN-2014, 51 degrees Fahrenheit for 5 minutes and on 18-JUL-2014, 48 degrees Fahrenheit for 24-minutes. The M.A. also stated she did not have patient identifiers, lot numbers, expiration dates, or dates of administration available at the time. Follow up information has been received on 06-AUG-2014 from medical assistant and refers to 3 month old patient of unknown gender who on 23-JUL-2014 was vaccinated with improperly stored dose of ROTATEQ, lot#K004480, expiration date 05-FEB-2016 (dose not reported). This is one of several reports received from the same source. Additional information is not expected.
Age: 4.0
Sex: U
Vaccine: MMR
Symptoms: Incorrect storage of drug, No adverse event
Clinical narrative: This spontaneous report as received from a registered nurse refers to a 4 years old patient of unknown gender. On 11-JUL-2014 the patient ws vaccinated with M-M-R II (therapy type: rHA, batch number: J005846, lot: 1681AA, expiry date: 17-APR-2015) that on 03/03/2014 was exposed to an unsupported temperature excursion (temperature range 45F, time frame: 24h). No adverse effect was reported. This is one of several reports received from the same reporter. Additional information has been requested.
Age: 26.0
Sex: F
Vaccine: HPV4
Symptoms: Abdominal distension, Back pain, Dizziness, Fall, Headache
Clinical narrative: This spontaneous report as received from a 26 year old female consumer refers to herself. The patient's pertinent medical history included sickle cell. There were no concomitant medication and drug reactions/allergies reported. In August 2013 the patient was vaccinated with the first dose of GARDASIL (lot#, strength, dosage and route unknown) because she had HPV. And the patient got a little sick after vaccination. In October 2013 the patient was vaccinated with the second dose of GARDASIL (lot#, strength, dosage and route unknown). The patient also missed a menstrual period in "May". The patient got bloated, she got real big, she got rashes, she was getting fat and getting water in her leg and she was throwing up real bad. She got real sick one time, she was so sick that she tried to get out of bed she actually fell out of the bed. She was shaking real bad like she was having a seizure, her back was hurting so bad like someone was stabbing her, she had headaches, migraines, dizziness, the whole nine yards. The patient took a ton of pregnancy tests because she thought she was pregnant but they all came back negative. The patient kept going to the hospital and the doctors' office, almost every day, because she did not know what was going on. She never stayed there though. She also missed a menstrual period in "May" (probably May 2014). The patient did not receive treatment for the adverse events. The outcome of the events was reported as not recovered. Additional information is not expected.
Age: 26.0
Sex: F
Vaccine: HPV4
Symptoms: Malaise, Menstruation delayed, Migraine, Oedema peripheral, Pregnancy test negative
Clinical narrative: This spontaneous report as received from a 26 year old female consumer refers to herself. The patient's pertinent medical history included sickle cell. There were no concomitant medication and drug reactions/allergies reported. In August 2013 the patient was vaccinated with the first dose of GARDASIL (lot#, strength, dosage and route unknown) because she had HPV. And the patient got a little sick after vaccination. In October 2013 the patient was vaccinated with the second dose of GARDASIL (lot#, strength, dosage and route unknown). The patient also missed a menstrual period in "May". The patient got bloated, she got real big, she got rashes, she was getting fat and getting water in her leg and she was throwing up real bad. She got real sick one time, she was so sick that she tried to get out of bed she actually fell out of the bed. She was shaking real bad like she was having a seizure, her back was hurting so bad like someone was stabbing her, she had headaches, migraines, dizziness, the whole nine yards. The patient took a ton of pregnancy tests because she thought she was pregnant but they all came back negative. The patient kept going to the hospital and the doctors' office, almost every day, because she did not know what was going on. She never stayed there though. She also missed a menstrual period in "May" (probably May 2014). The patient did not receive treatment for the adverse events. The outcome of the events was reported as not recovered. Additional information is not expected.