chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 39.0
Sex: M
Vaccine: FLUX, FLUX
Symptoms: Nuclear magnetic resonance imaging abnormal, Red blood cell sedimentation rate normal, Soft tissue inflammation, White blood cell count decreased
Clinical narrative: This medically confirmed literature report (initial receipt 22-Jul-2014) concerns a 39-year-old male. On an unknown date, the patient received Influenza virus vaccine (manufacturer and batch number not provided). On an unknown date, immediately following influenza vaccination, the patient developed left shoulder pain. On an unknown date, two months following the vaccination, the patient presented at the clinic with prolonged, increasing left shoulder pain. The physical examination was normal. On laboratory assessment, leukopenia was noted on CBC (3-4,700 on serial tests for 4 months) without defined source, although counts were otherwise normal. ESR was normal. BMI was recorded as 25.7 kg/m2. The MRI of the shoulder was performed three months following vaccination. It showed Magnetic resonance imaging showed oblique coronal image and oblique sagittal fat-saturated T2 weighted image which showed focal subcortical bone marrow edema-like signal within the greater tuberosity, without associated obvious cortical destruction. The subcutaneous fat thickness was measured to be 4.7 mm on oblique coronal T1-weighted sequences. Hyperintense T2 signal along the periosteum indicated periosteal reaction. There were periosseous soft tissue inflammatory changes and small subacromial/subdeltoid bursal fluid. Laboratory testing did not support any infectious etiology. The patient was not actively anti-coagulated. Sagittal T1-weighted imaging showed hypointense bone marrow signal. The patient was treated conservatively with non-steroidal anti-inflammatory agents for 2 weeks and had complete resolution of symptoms after 5.5 months of observation. Outcome was reported as recovered. Authors comment: A causal relationship between vaccine administration and deltoid bursitis has been formally established. It has been reported that unintentional injection of vaccine antigen into subacromial/subdeltoid bursa can trigger an inflammatory reaction. Due to variable body habitus and muscle size, the optimum point for vaccine injection may vary among individuals. An improper angle of approach of the needle or increased needle length may result in bursal or cortical penetration, particularly in those with low BMI.
Age: 63.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site erythema, Injection site reaction, Urticaria
Clinical narrative: This spontaneous report as received from a pharmacist refers to a 63 year old female patient with no pertinent medical history. Drug reactions/allergies included macrolides, ketolides and ethanol. On 22-MAY-2014 the patient was vaccinated with a dose of ZOSTAVAX lot # J014812, Expiry: 20-FEB-2015, (0.65ml, dose number, strength and frequency unspecified) subcutaneous. No concomitant medication was reported. On 23-MAY-2014 the patient developed an injection site reaction that consisted of a large, round, red welt. There was no rash. The patient did not seek medical attention. No lab diagnostics studies were performed. The outcome of the event was reported as recovered 10 days after onset of symptoms (on 02-JUN-2014). Additional information has been requested.
Sex: F
Vaccine: HPV4
Symptoms: Inappropriate schedule of drug administration, No adverse event
Clinical narrative: This spontaneous report as received from a nurse refers to a female patient of unknown age. On 14-MAR-2014 the patient was vaccinated with first dose GARDASIL (lot # not reported) 0.5 ml, intramuscular. Other doses of GARDASIL were given respectively (both intramuscularly and 0.5 ml) on 16-MAY-2014 (Second dose), 29-JUL-2014 (Third dose). No adverse effect reported. The outcome of the event was unknown. Additional information has been requested.
Age: 61.0
Sex: F
Vaccine: VARZOS
Symptoms: Erythema, Injection site erythema, Injection site pain, Injection site vesicles, Rash erythematous
Clinical narrative: This spontaneous report as received from a nurse practitioner via field representative refers to a 61 year old female patient with allergy rhinitis, gastroesophageal reflux disease (GERD). Allergies included pseudoephedrine; BUPROPION; methylprednisone; NORCO; PERCOCET; FENTENYL, DILAUDID, erythromycin, methylprednisone, codeine, VERSED, MIDOL and caffeine. On 21-JUL-2014 the patient was vaccinated with ZOSTAVAX lot # J014812, expiration date:20-FEB-2015, 0.65 ml in the left arm (strength and route unknown). On 21=JUL-2014, the patient experienced severe pain, blisters and redness around the injection site. It was also reported that on that day, post vaccination, the red vesicular rash occurred, vesicular rash and erythema extending elbow to axilla with multiple blisters at injection site. The patient visited the office on unspecified date. The outcome of the events was reported as recovered on 28-JUL-2014, reported as healing. The patient did not have recent VZV exposure to chickenpox or shingles. Additional information has been requested.
Age: 61.0
Sex: F
Vaccine: VARZOS
Symptoms: Rash vesicular
Clinical narrative: This spontaneous report as received from a nurse practitioner via field representative refers to a 61 year old female patient with allergy rhinitis, gastroesophageal reflux disease (GERD). Allergies included pseudoephedrine; BUPROPION; methylprednisone; NORCO; PERCOCET; FENTENYL, DILAUDID, erythromycin, methylprednisone, codeine, VERSED, MIDOL and caffeine. On 21-JUL-2014 the patient was vaccinated with ZOSTAVAX lot # J014812, expiration date:20-FEB-2015, 0.65 ml in the left arm (strength and route unknown). On 21=JUL-2014, the patient experienced severe pain, blisters and redness around the injection site. It was also reported that on that day, post vaccination, the red vesicular rash occurred, vesicular rash and erythema extending elbow to axilla with multiple blisters at injection site. The patient visited the office on unspecified date. The outcome of the events was reported as recovered on 28-JUL-2014, reported as healing. The patient did not have recent VZV exposure to chickenpox or shingles. Additional information has been requested.
Age: 82.0
Sex: F
Vaccine: TDAP
Symptoms: Agitation, Anxiety, Balance disorder, Chills, Fall
Clinical narrative: About 12 hrs after injection - onset of anxiety, agitation, unsteadiness - loss of balance with fall. Chills - 24 hrs after injection.
Age: 26.0
Sex: U
Vaccine: MMR
Symptoms: Expired drug administered, No adverse event
Clinical narrative: This spontaneous report was received from a physician refers to a 26 year old patient of unknown gender. On 04-AUG-2014 the patient was vaccinated with an expired M-M-R II (Lot # H011907, Expiration Date: 03-JUL-2014) (dose and route of administration were not reported). The patient had not reported or demonstrated any adverse effects. 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 healthcare worker refers to a patients of unknown age and gender. It was reported that GARDASIL, that was improperly stored since 07-APR-2014 to 22-JUL-2014, was administered to unspecified patients on unspecified dates. No adverse effects reported. This is one of several reports from the same source. Additional information has been requested.
Sex: U
Vaccine: VARCEL
Symptoms: Expired drug administered, No adverse event
Clinical narrative: This spontaneous report as received from a nurse refers to a patient of unknown age and gender. Information regarding concurrent conditions and medical history was not provided. On 31-JUL-2014 the patient was vaccinated with 0.5ml expired dose of VARIVAX (Merck) (injection, lot # H014272, expiration date 25-JUL-2014, subcutaneous). Concomitant medications were not provided. No adverse effect was reported. Additional information has been requested.
Sex: U
Vaccine: MMRV
Symptoms: Injection site erythema, Injection site induration, Injection site pain, Injection site warmth
Clinical narrative: This spontaneous report as received from a nurse refers to unspecified patients of unknown age. On unknown dates, the patients were administered PROQUAD (Merck) (0.5 ml, subcutaneous, lot number, expiration date unknown). The nurse mentioned that she had noticed an increased incidence of injection site reactions when PROQUAD (Merck) (0.5ml, subcutaneous) was administered in the same arm as KINRIX (route, dose, lot number, expiration date unknown). The injection site reactions varied in intensity and could include erythema, induration, warmth, and tenderness. The patients sought for medical attention by office visit. Some patients had required unspecified oral antibiotic therapy and some patients had been advised to apply cold compresses to the reaction. The outcome of the events was unknown. Additional information has been requested.
Age: 0.17
Sex: F
Vaccine: DTAPIPVHIB, PNC13, RV5
Symptoms: Crying, Intussusception, Pain, Small intestinal intussusception reduction, Ultrasound abdomen abnormal
Clinical narrative: Transient small bowel - small bowel intussusception with reduction during abdominal ultrasound. 3 days of increasing episodes of painful crying, drawing up legs.
Age: 11.0
Sex: M
Vaccine: HPV4, HEPA, HPV4, MNQ, TDAP
Symptoms: Eye movement disorder, Immediate post-injection reaction, Lethargy, Posture abnormal, Presyncope
Clinical narrative: This spontaneous report as received from a other health professional refers to a 11 year old male patient. The patient did not have any pertinent medical history or drug reactions/allergies. On 21-JUL-2014, the patient was vaccinated with a first dose of GARDASIL (lot # J009243, expiration date 23-APR-2016) 0.5 ml, intramuscular for immunization along with MENVEO, DTaP vaccine (unspecified), TdaP and hepatitis a vaccine (manufacturer unknown). On 21-JUL-2014, immediately after the GARDASIL was administered, the patient's head rolled back and his eyes rolled back in his head. She stated that he experienced a "vaso vagal event". The patient was sitting during the injection and did not have any injury. The patient "came back to" shortly after and reported feeling lethargic. No treatment was given. No lab diagnostic studies were performed. On 21-JUL-2014, the patient recovered from the events. Additional information has been requested.
Age: 11.0
Sex: M
Vaccine: HPV4, HEPA, HPV4, MNQ, TDAP
Symptoms: Dizziness, Electrocardiogram QT prolonged, Electrocardiogram abnormal, Eye movement disorder, Immediate post-injection reaction
Clinical narrative: This spontaneous report as received from a other health professional refers to a 11 year old male patient. The patient did not have any pertinent medical history or drug reactions/allergies. On 21-JUL-2014, the patient was vaccinated with a first dose of GARDASIL (lot # J009243, expiration date 23-APR-2016) 0.5 ml, intramuscular for immunization along with MENVEO, DTaP vaccine (unspecified), TdaP and hepatitis a vaccine (manufacturer unknown). On 21-JUL-2014, immediately after the GARDASIL was administered, the patient's head rolled back and his eyes rolled back in his head. She stated that he experienced a "vaso vagal event". The patient was sitting during the injection and did not have any injury. The patient "came back to" shortly after and reported feeling lethargic. No treatment was given. No lab diagnostic studies were performed. On 21-JUL-2014, the patient recovered from the events. Additional information has been requested.
Age: 11.0
Sex: M
Vaccine: HPV4, HEPA, HPV4, MNQ, TDAP
Symptoms: Lethargy, Loss of consciousness, Neurological examination normal, Posture abnormal, Presyncope
Clinical narrative: This spontaneous report as received from a other health professional refers to a 11 year old male patient. The patient did not have any pertinent medical history or drug reactions/allergies. On 21-JUL-2014, the patient was vaccinated with a first dose of GARDASIL (lot # J009243, expiration date 23-APR-2016) 0.5 ml, intramuscular for immunization along with MENVEO, DTaP vaccine (unspecified), TdaP and hepatitis a vaccine (manufacturer unknown). On 21-JUL-2014, immediately after the GARDASIL was administered, the patient's head rolled back and his eyes rolled back in his head. She stated that he experienced a "vaso vagal event". The patient was sitting during the injection and did not have any injury. The patient "came back to" shortly after and reported feeling lethargic. No treatment was given. No lab diagnostic studies were performed. On 21-JUL-2014, the patient recovered from the events. Additional information has been requested.
Age: 11.0
Sex: M
Vaccine: HPV4, HEPA, HPV4, MNQ, TDAP
Symptoms: Sinus bradycardia, Syncope
Clinical narrative: This spontaneous report as received from a other health professional refers to a 11 year old male patient. The patient did not have any pertinent medical history or drug reactions/allergies. On 21-JUL-2014, the patient was vaccinated with a first dose of GARDASIL (lot # J009243, expiration date 23-APR-2016) 0.5 ml, intramuscular for immunization along with MENVEO, DTaP vaccine (unspecified), TdaP and hepatitis a vaccine (manufacturer unknown). On 21-JUL-2014, immediately after the GARDASIL was administered, the patient's head rolled back and his eyes rolled back in his head. She stated that he experienced a "vaso vagal event". The patient was sitting during the injection and did not have any injury. The patient "came back to" shortly after and reported feeling lethargic. No treatment was given. No lab diagnostic studies were performed. On 21-JUL-2014, the patient recovered from the events. Additional information has been requested.
Age: 0.33
Sex: F
Vaccine: DTAPIPVHIB, PNC13, RV5
Symptoms: Diarrhoea, Haematochezia, Screaming, Small intestinal intussusception reduction, Ultrasound abdomen abnormal
Clinical narrative: Transient small bowel - small bowel intussusception with reduction during ultrasound. Screaming episodes x12 hours with diarrhea x3 days prior with blood in stool day of presentation. No fever.
Age: 1.4
Sex: M
Vaccine: HEP, MMR, PNC13, VARCEL
Symptoms: Computerised tomogram head normal, Musculoskeletal stiffness, Postictal state, Roseola
Clinical narrative: 30 minute episode w/10 min stiffened limbs w/postictal state, 2nd sz after apparent roseola.
Age: 43.0
Sex: F
Vaccine: PPV, TDAP
Symptoms: Injection site erythema, Injection site induration, Injection site pain, Pyrexia
Clinical narrative: 2 1/2 in " by 4" (R) arm below redness pain induration. Bandaid Tdap fever 102 degrees.
Age: 5.0
Sex: F
Vaccine: DTAPIPV, MMRV
Symptoms: Injection site erythema, Injection site induration, Injection site warmth
Clinical narrative: Localized redness, warmth and induration of thighs (R) 9 cm x 4.5 cm (L) 3 cm x 5 cm. Treatments cool compress, BENADRYL. By today, (R) side was still enlarging, (L) side subsiding.
Age: 60.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site erythema, Injection site induration, Injection site swelling, Injection site warmth
Clinical narrative: Patient came in with redness, heat, hardness and swelling at injection site.
Age: 18.0
Sex: F
Vaccine: MNQ
Symptoms: Malaise, Syncope, Throat irritation
Clinical narrative: Patient administered MENVEO vaccine, felt okay and left office. Pt fainted outside of office and brought back in to office to rest. Wasn't feeling well and said her throat felt funny; she was taken to emergency room by parent.
Age: 1.01
Sex: F
Vaccine: MMRV, PNC13, VARCEL
Symptoms: No adverse event
Clinical narrative: No symptoms noted per patient: Clinic recognized count of MMR and MMRV was off. Reviewed chart and determined that even through MMR was documented to lot # was for MMRV.
Age: 13.0
Sex: M
Vaccine: MMRV
Symptoms: Drug administered at inappropriate site, No adverse event
Clinical narrative: This spontaneous report as received from a registered nurse refers to a 13 year and 8 months old male patient. Medical history and drug reactions/allergies were not reported. On approximately 30-JUN-2014 (reported as 4 weeks ago), the patient was vaccinated with PROQUAD (Merck) (lot, dose and route was not reported). Concomitant medication was not reported. No adverse effects reported. The patient did not seek for medical attention. Additional information is not expected as there is no permission for follow up.
Age: 17.0
Sex: F
Vaccine: HPV4, HPV4
Symptoms: Exposure during pregnancy, Pregnancy test urine positive
Clinical narrative: This spontaneous prospective pregnancy report as received from a licensed practical nurse refers to a 17 year old female patient with adolescent depression. None drug reactions or allergies were reported. On 25-JUN-2014 the patient was vaccinated with GARDASIL lot # J013324, dose 1, expiration date 12-FEB-2016, 0.5 ml and lot # J009243, dose 2, expiration date 23-APR-2016, 0.5 ml, intramuscular for vaccination (strength and anatomical location were unspecified). Concomitant therapies included iron (unspecified), minerals (unspecified), vitamins (unspecified) (reported as PRENATAL VITAMINS). The patient became pregnant with last menstrual period of 26-JUN-2014 and estimated delivery date of 02-APR-2015. Initial exposure to GARDASIL was at 4 weeks. The pregnancy outcome was pending. On 28-JUL-2104, the patient experienced patient who has received 1 doses of GARDASIL while pregnant (reported as the patient who has received 2 doses of GARDASIL is pregnant). Urine pregnancy test was performed at physician's office (positive). The outcome of the event was unknown. Additional information has been requested.
Age: 17.0
Sex: F
Vaccine: HPV4, HPV4
Symptoms: Exposure during pregnancy
Clinical narrative: This spontaneous prospective pregnancy report as received from a licensed practical nurse refers to a 17 year old female patient with adolescent depression. None drug reactions or allergies were reported. On 25-JUN-2014 the patient was vaccinated with GARDASIL lot # J013324, dose 1, expiration date 12-FEB-2016, 0.5 ml and lot # J009243, dose 2, expiration date 23-APR-2016, 0.5 ml, intramuscular for vaccination (strength and anatomical location were unspecified). Concomitant therapies included iron (unspecified), minerals (unspecified), vitamins (unspecified) (reported as PRENATAL VITAMINS). The patient became pregnant with last menstrual period of 26-JUN-2014 and estimated delivery date of 02-APR-2015. Initial exposure to GARDASIL was at 4 weeks. The pregnancy outcome was pending. On 28-JUL-2104, the patient experienced patient who has received 1 doses of GARDASIL while pregnant (reported as the patient who has received 2 doses of GARDASIL is pregnant). Urine pregnancy test was performed at physician's office (positive). The outcome of the event was unknown. Additional information has been requested.
Sex: U
Vaccine: HBHEPB
Symptoms: Incorrect storage of drug, No adverse event
Clinical narrative: This spontaneous report as received from a healthcare worker refers to a patients of unknown age and gender. It was reported that COMVAX that was improperly stored since 07-APR-2014 to 22-JUL-2014, was administered to unspecified patients on unspecified dates. No adverse effects reported. This is one of several reports from the same source. Additional information has been requested.
Sex: U
Vaccine: HEP
Symptoms: Incorrect storage of drug, No adverse event
Clinical narrative: This spontaneous report as received from a healthcare worker refers to a patients of unknown age and gender. It was reported that RECOMBIVAX HB that was improperly stored since 07-APR-2014 to 22-JUL-2014, was administered to unspecified patients on unspecified dates. No adverse effects reported. This is one of several reports from the same source. Additional information has been requested.
Age: 66.0
Sex: U
Vaccine: VARZOS, VARZOS
Symptoms: Herpes zoster, Rash
Clinical narrative: This spontaneous report as received from a physician via a company representative refers to a 66 year old patient of unknown gender. On 16-JUN-2014 the patient was vaccinated with a dose of ZOSTAVAX lot # reported as J012657 expiry date January 2015 (dose, units, route of administration, anatomical location were not reported). On 23-JUN-2014 (reported as 7 days later) the patient developed shingles. The patient went to an unspecified urgent care facility on an unknown date for treatment. The outcome of developed shingles was reported as recovered/resolved on unknown date in 2014. The relatedness between adverse event and ZOSTAVAX was not reported. Additional information has been requested.
Age: 66.0
Sex: U
Vaccine: VARZOS, VARZOS
Symptoms: Herpes zoster
Clinical narrative: This spontaneous report as received from a physician via a company representative refers to a 66 year old patient of unknown gender. On 16-JUN-2014 the patient was vaccinated with a dose of ZOSTAVAX lot # reported as J012657 expiry date January 2015 (dose, units, route of administration, anatomical location were not reported). On 23-JUN-2014 (reported as 7 days later) the patient developed shingles. The patient went to an unspecified urgent care facility on an unknown date for treatment. The outcome of developed shingles was reported as recovered/resolved on unknown date in 2014. The relatedness between adverse event and ZOSTAVAX was not reported. Additional information has been requested.
Age: 69.0
Sex: F
Vaccine: PPV, PPV
Symptoms: Mobility decreased, Musculoskeletal pain, Pain in extremity, Tenderness
Clinical narrative: This spontaneous report as received from a pharmacist refers to a 69 year old female patient. On 25-JUL-2014 the patient was vaccinated with a dose of PNEUMOVAX 23 (lot # K005797, expiration date: 21-MAR-2015), 0.5 ml, intramuscular in an unspecified arm. On 25-JUL-2014, the patient experienced so much pain in her upper arm. The patient sought medical attention from pharmacist by calling the pharmacist on 25-JUL-2014. The patient stated on 25-JUL-2014 she had so much pain in her arm that she could not raise it up more than a couple of inches and could not lay on her arm or roll on her arm at all. The patient also stated to pharmacist that she felt like her arm had been hit with a baseball bat. No lab diagnostic studies were performed. Treatment with TYLENOL and ice periodically on Friday night and Saturday. Patient stated to pharmacist on 27-JUL-2014 that she was a tiny bit better. At the time of the report, the patient was recovering. Additional information has been requested.
Age: 69.0
Sex: F
Vaccine: PPV, PPV
Symptoms: Mobility decreased, Pain in extremity
Clinical narrative: This spontaneous report as received from a pharmacist refers to a 69 year old female patient. On 25-JUL-2014 the patient was vaccinated with a dose of PNEUMOVAX 23 (lot # K005797, expiration date: 21-MAR-2015), 0.5 ml, intramuscular in an unspecified arm. On 25-JUL-2014, the patient experienced so much pain in her upper arm. The patient sought medical attention from pharmacist by calling the pharmacist on 25-JUL-2014. The patient stated on 25-JUL-2014 she had so much pain in her arm that she could not raise it up more than a couple of inches and could not lay on her arm or roll on her arm at all. The patient also stated to pharmacist that she felt like her arm had been hit with a baseball bat. No lab diagnostic studies were performed. Treatment with TYLENOL and ice periodically on Friday night and Saturday. Patient stated to pharmacist on 27-JUL-2014 that she was a tiny bit better. At the time of the report, the patient was recovering. Additional information has been requested.
Age: 10.0
Sex: F
Vaccine: DTAP, TDAP
Symptoms: Abdominal pain upper, Crying, Pyrexia, Vomiting
Clinical narrative: Fever 104. Fatigue. Body aches, joint pains. Dizziness, vomiting. Duration 48 hours. Patient treated at home and symptoms reported by parents. No medical visit.
Age: 10.0
Sex: F
Vaccine: DTAP, TDAP
Symptoms: Arthralgia, Dizziness, Fatigue, Pain, Pyrexia
Clinical narrative: Fever 104. Fatigue. Body aches, joint pains. Dizziness, vomiting. Duration 48 hours. Patient treated at home and symptoms reported by parents. No medical visit.
Age: 10.0
Sex: F
Vaccine: DTAP, TDAP
Symptoms: Vomiting
Clinical narrative: Fever 104. Fatigue. Body aches, joint pains. Dizziness, vomiting. Duration 48 hours. Patient treated at home and symptoms reported by parents. No medical visit.
Sex: U
Vaccine: DTAPHEPBIP, HIBV, PNC13, RV5, RV5
Symptoms: Inappropriate schedule of drug administration
Clinical narrative: This spontaneous report as received from a nurse refers to an infant patient of unknown gender (exact age not specified). Medical history and concurrent conditions were not specified. On 14-JUL-2014, the patient ws vaccinated with a first dose of ROTATEQ lot number reported as J012521, expiration date 22-APR-2015, 2 ml, orally (by mouth). On 04-AUG-2014, the patient was vaccinated with the second dose of ROTATEQ lot number reported as K001726, expiration date 24-NOV-2015, 2 ml, orally (by mouth). Concomitant medications were not specified. The infant received two doses of ROTATEQ only 3 weeks apart. No adverse effects were reported. Additional information has been requested.
Sex: U
Vaccine: DTAPHEPBIP, HIBV, PNC13, RV5, RV5
Symptoms: Inappropriate schedule of drug administration, No adverse event
Clinical narrative: This spontaneous report as received from a nurse refers to an infant patient of unknown gender (exact age not specified). Medical history and concurrent conditions were not specified. On 14-JUL-2014, the patient ws vaccinated with a first dose of ROTATEQ lot number reported as J012521, expiration date 22-APR-2015, 2 ml, orally (by mouth). On 04-AUG-2014, the patient was vaccinated with the second dose of ROTATEQ lot number reported as K001726, expiration date 24-NOV-2015, 2 ml, orally (by mouth). Concomitant medications were not specified. The infant received two doses of ROTATEQ only 3 weeks apart. No adverse effects were reported. Additional information has been requested.
Sex: F
Vaccine: HPV4
Symptoms: Adverse event, Wheelchair user
Clinical narrative: This spontaneous report was received from a Journalist refers to a female patient of unknown age. On an unknown date, the patient was vaccinated with GARDASIL for (dose, route and lot # were not reported). On an unknown date, the patient experienced unspecified adverse effects that has left her wheelchair bound, after receiving GARDASIL. The outcome of unspecified adverse effects that has left her wheelchair bound was unknown. This is one report of several reports from the same source (MARRS # 1408USA001101). This case was considered medically significant due to patient disabling. Additional information has been requested.
Age: 15.0
Sex: F
Vaccine: HPV4
Symptoms: Computerised tomogram, Loss of consciousness, Tremor, Vomiting
Clinical narrative: My daughter recieved the 3rd dose of HPV with in 10 hours she was shaking throwing up and passed out.  We had to call 911.
Age: 54.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site erythema, Injection site pruritus, Tenderness
Clinical narrative: Red, itchy patch, 1.5" by 4", extending down from injection site.  Also extreme tenderness in underarm area.
Sex: F
Vaccine: VARZOS
Symptoms: Injection site bruising, Injection site erythema, Injection site swelling, Injection site warmth
Clinical narrative: This spontaneous report as received from a pharmacist via a company representative refers to herself. On an unknown date the patient was vaccinated with a dose of ZOSTAVAX (reported as 1 single shot) (lot#, expiration date and dose were unknown) subcutaneous. On unknown date (reported as the next day after receiving the ZOSTAVAX), there was a bruise below the injection site, it was red, warm, and swollen.; This injection site lasted 8-10 days before it resolved itself. No treatment was given for the event. No lab diagnostics studies were performed. The patient did not seek for medical attention. The outcome of the event ws reported as recovered. Additional information has been requested.
Age: 5.0
Sex: U
Vaccine: VARCEL, VARZOS
Symptoms: Incorrect dose administered, No adverse event
Clinical narrative: This spontaneous report as received from a medical assistant refers to a 5 year old patient. No information about medical history, drug reactions and allergies were specified. The reporter stated that on 04-AUG-2014 she inadvertently administered both ZOSTAVAX (lot # not reported0 subcutaneous and (Oka/Merck) VARIVAX (lot # dose, route not reported) to the 5 year old patient. No concomitant medications were reported. No adverse effects reported. There was no product quality complaint. 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 registered nurse refers to unspecified patients of unknown age. On unspecified dates, the patients were vaccinated with (Oka/Merck) VARIVAX which was exposed to unknown temperatures out of the recommended range for an unknown period of time (dose, route, lot# and expiration date unknown). No adverse effect had been reported. This is one of several reports received from the same source. Additional information has been requested.
Sex: U
Vaccine: HEP
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 demographics. No concurrent conditions or medical history were provided. The medical assistant reported that those patients were administered with a doses of RECOMBIVAX HB (doses, routes of administration, indications, lot#, expiry dates unspecified) between 13-OCT-2013 and 13-NOV-2013 that had been improperly stored. No concomitant medications were reported. No adverse effects were reported. This is one of several reports from the same source. Additional information has been requested.
Age: 1.26
Sex: U
Vaccine: HIBV
Symptoms: Incorrect storage of drug, No adverse event
Clinical narrative: This spontaneous report as received from a registered nurse refers to an unspecified number of patients of unknown age and genders. The reporter stated that, on an unspecified date, an unknown number of doses of LIQUID PEDVAXHIB (dose, lot#, expiration dates not provided) that were stored at 48 degrees F for 20 minutes then exposed to 47 degrees for 9 minutes have been administered. No adverse effects were reported.   Follow up information has been received on 22-JUL-2014 from a receptionist. The reporter stated that there were two different lot numbers of LIQUID PEDVAXHIB that were included in the temperature excursion: Lot#J016188, expiration date:02-OCT-2016 and lot# J015437, expiration date: 09-OCT-2016.  The receptionist did not have any additional information to share.  Follow-up information has been received from the registered nurse who provided patients details. This report refers to a 15 months old child patient of unknown gender. On 24-JUN-2014 the patient was vaccinated with a dose of LIQUID PEDVAXHIB (dose and route not reported, lot # J015437, expiration date 09-OCT-2016) that was improperly stored. No adverse effects were reported. Thi sis one of several reports received from the same reporter. Additional information is not expected.
Age: 0.25
Sex: F
Vaccine: DTAPHEPBIP, HIBV, PNC13, RV5
Symptoms: Injection site urticaria
Clinical narrative: Mother of pt noticed a few small hives on the pt's left leg.
Age: 0.17
Sex: U
Vaccine: HIBV
Symptoms: Incorrect storage of drug, No adverse event
Clinical narrative: This spontaneous report as received from a registered nurse refers to an unspecified number of patients of unknown age and genders. The reporter stated that, on an unspecified date, an unknown number of doses of LIQUID PEDVAXHIB (dose, lot#, expiration dates not provided) that were stored at 48 degrees F for 20 minutes then exposed to 47 degrees for 9 minutes have been administered. No adverse effects were reported.   Follow up information has been received on 22-JUL-2014 from a receptionist. The reporter stated that there were two different lot numbers of LIQUID PEDVAXHIB that were included in the temperature excursion: Lot#J016188, expiration date:02-OCT-2016 and lot# J015437, expiration date: 09-OCT-2016.  The receptionist did not have any additional information to share.  Follow-up information has been received from the registered nurse who provided patients details. This report refers to a 8 weeks old child patient of unknown gender. On 26-JUN-2014 the patient was vaccinated with a dose of LIQUID PEDVAXHIB (dose and route not reported, lot # J016188, expiration date 02-OCT-2016) that was improperly stored. No adverse effects were reported. This is one of several reports received from the same reporter. Additional information is not expected.
Age: 25.0
Sex: F
Vaccine: HPV4
Symptoms: Arthralgia, Chills, Nausea, Pyrexia, Rash
Clinical narrative: This spontaneous report as received from a nurse refers to a 25 year old female patient with allergies to penicillin and sulfa drugs-unspecified reaction and no pertinent medical history. On 22-MAY-2014 the patient was vaccinated with the first dose of GARDASIL (lot#, strength, dosage, route not reported) and experienced no type of reaction, then had a 2nd dose of GARDASIL (lot # J015378, expiration date: 09-APR-2016, dosage and route unknown) administered on 24-JUL-2014 and began to experience "rash, fever, chills, nausea, and joint pain" on an unspecified date after the 2nd administration. Concomitant therapies included NUVARING. Nurse reported that the patient went to an unspecified emergency department on an unspecified date for treatment due to the symptoms but did not know if the patient was admitted to the hospital. No lab diagnostics studies was performed. Nurse reported that the patient was treated with MOTRIN (unspecified dose and frequency) for fever and ZOFRAN (unspecified dose and frequency) for nausea. Nurse reported that the patient stated on the reporting day, 01-AUG-2014, that she was recovering from the symptoms. Additional information has been requested.
Sex: U
Vaccine: MMRV, VARCEL
Symptoms: Accidental overdose, No adverse event
Clinical narrative: This spontaneous report as received from a registered nurse refers to a patient of unknown age and gender. On 28-JUL-2014 the patient was vaccinated with 0.5ml dose of (oka/MERCK) VARIVAX, subcutaneous (lot#, strength and frequency unspecified) and 0.5ml dose of (oka/MERCK) PROQUAD (lot#, strength, route and frequency unspecified) inadvertently. No adverse effects reported. Additional information has been requested.
Sex: F
Vaccine: VARZOS
Symptoms: Injection site reaction
Clinical narrative: This spontaneous report as received from a certified medical assistant via a company representative who learned of this event refers to a female patient of unknown age who was a retired nurse. In 2014 (reported as a few week ago) the patient was vaccinated with a dose of ZOSTAVAX (lot #, dose, frequency and route unspecified). The patient experienced an unspecified injection site reaction after receiving ZOSTAVAX a few week ago in 2014. The outcome of the event was unknown. Additional information has been requested.
Age: 5.0
Sex: U
Vaccine: HEPA
Symptoms: No adverse event, Off label use
Clinical narrative: This spontaneous report as received from a health professional refers to a 5 year old patient. On 29-JUL-2014 the patient was vaccinated with a partial adult dose of VAQTA (lot#, expiration date and strength were unknown), 0.75ml was given. No adverse effects were reported. Additional information is not expected as we cannot contact the physician/health professional.
Sex: U
Vaccine: PPV
Symptoms: Drug administered at inappropriate site, 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 an unknown date the patient was vaccinated subcutaneously with a dose of PNEUMOVAX23 (dose, frequency and lot # not reported) into the "back of the arm" not into the deltoid muscle. No adverse effects reported. Additional information has been requested.
Age: 1.96
Sex: U
Vaccine: HIBV, HIBV
Symptoms: Incorrect storage of drug, No adverse event
Clinical narrative: This spontaneous report as received from a registered nurse refers to an unspecified number of patients of unknown age and genders. The reporter stated that, on an unspecified date, an unknown number of doses of LIQUID PEDVAXHIB (dose, lot#, expiration dates not provided) that were stored at 48 degrees F for 20 minutes then exposed to 47 degrees for 9 minutes have been administered. No adverse effects were reported.   Follow up information has been received on 22-JUL-2014 from a receptionist. The reporter stated that there were two different lot numbers of LIQUID PEDVAXHIB that were included in the temperature excursion: Lot#J016188, expiration date:02-OCT-2016 and lot# J015437, expiration date: 09-OCT-2016.  The receptionist did not have any additional information to share.  Follow-up information has been received from the registered nurse who provided patients details. This report refers to a 23 months old child patient of unknown gender. On 26-JUN-2014 the patient was vaccinated with a dose of LIQUID PEDVAXHIB (dose and route not reported, lot # J016188, expiration date 02-OCT-2016) that was improperly stored. No adverse effects were reported. This is one of several reports received from the same reporter. Additional information is not expected.
Age: 1.29
Sex: U
Vaccine: HIBV, HIBV
Symptoms: Incorrect storage of drug, No adverse event
Clinical narrative: This spontaneous report as received from a registered nurse refers to an unspecified number of patients of unknown age and genders. The reporter stated that, on an unspecified date, an unknown number of doses of LIQUID PEDVAXHIB (dose, lot#, expiration dates not provided) that were stored at 48 degrees F for 20 minutes then exposed to 47 degrees for 9 minutes have been administered. No adverse effects were reported.   Follow up information has been received on 22-JUL-2014 from a receptionist. The reporter stated that there were two different lot numbers of LIQUID PEDVAXHIB that were included in the temperature excursion: Lot#J016188, expiration date:02-OCT-2016 and lot# J015437, expiration date: 09-OCT-2016.  The receptionist did not have any additional information to share.  Follow-up information has been received from the registered nurse who provided patients details. This report refers to a 15 months old child patient of unknown gender. On 25-JUN-2014 the patient was vaccinated with a dose of LIQUID PEDVAXHIB (dose and route not reported, lot # J016188, expiration date 02-OCT-2016) that was improperly stored. No adverse effects were reported. This is one of several reports received from the same reporter. Additional information is not expected.
Sex: U
Vaccine: MMRV
Symptoms: Incorrect storage of drug, No adverse event
Clinical narrative: This spontaneous report as received from a registered nurse refers to unspecified number of patients of unknown age and gender. Since 23-MAY-2014 (approximately in 2014, exact date was not reported) unspecified number of patients were vaccinated with unspecified number of doses of PROQUAD (lot#J009885 expiration date: 12-FEB-2015) (dose not reported) that were exposed to temperatures outside of range on 23-MAY-2014. No concomitant medications were reported. No adverse effects were reported. This is one of several reports from the same reporter. Additional information has been requested.
Age: 1.34
Sex: U
Vaccine: HIBV
Symptoms: Incorrect storage of drug, No adverse event
Clinical narrative: This spontaneous report as received from a registered nurse refers to an unspecified number of patients of unknown age and genders. The reporter stated that, on an unspecified date, an unknown number of doses of LIQUID PEDVAXHIB (dose, lot#, expiration dates not provided) that were stored at 48 degrees F for 20 minutes then exposed to 47 degrees for 9 minutes have been administered. No adverse effects were reported.   Follow up information has been received on 22-JUL-2014 from a receptionist. The reporter stated that there were two different lot numbers of LIQUID PEDVAXHIB that were included in the temperature excursion: Lot#J016188, expiration date:02-OCT-2016 and lot# J015437, expiration date: 09-OCT-2016.  The receptionist did not have any additional information to share.  Follow-up information has been received from the registered nurse who provided patients details. This report refers to a 15 month old child patient of unknown gender. On 25-JUN-2014 the patient was vaccinated with a dose of LIQUID PEDVAXHIB (dose and route not reported, lot # J015437, expiration date 09-OCT-2016) that was improperly stored. No adverse effects were reported. This is one of several reports received from the same reporter. Additional information is not expected.
Age: 1.24
Sex: U
Vaccine: HIBV
Symptoms: Incorrect storage of drug, No adverse event
Clinical narrative: This spontaneous report as received from a registered nurse refers to an unspecified number of patients of unknown age and genders. The reporter stated that, on an unspecified date, an unknown number of doses of LIQUID PEDVAXHIB (dose, lot#, expiration dates not provided) that were stored at 48 degrees F for 20 minutes then exposed to 47 degrees for 9 minutes have been administered. No adverse effects were reported.   Follow up information has been received on 22-JUL-2014 from a receptionist. The reporter stated that there were two different lot numbers of LIQUID PEDVAXHIB that were included in the temperature excursion: Lot#J016188, expiration date:02-OCT-2016 and lot# J015437, expiration date: 09-OCT-2016.  The receptionist did not have any additional information to share.  Follow-up information has been received from the registered nurse who provided patients details. This report refers to a 14 months old child patient of unknown gender. On 12-JUN-2014 the patient was vaccinated with a dose of LIQUID PEDVAXHIB (dose and route not reported, lot # J015437, expiration date 09-OCT-2016) that was improperly stored. No adverse effects were reported. This is one of several reports received from the same reporter. Additional information is not expected.
Sex: U
Vaccine: HIBV
Symptoms: Drug administered to patient of inappropriate age, No adverse event
Clinical narrative: This spontaneous report as received from a pharmacist refers to two patients of unknown age and gender, who will be entering college in the fall. On an unknown date in 2014 ("recently") the patients were inadvertently vaccinated with a dose of LIQUID PEDVAXHIB (dosage, route and lot # not reported). No symptoms reported. The outcome of event was not reported. Additional information has been requested.
Age: 56.0
Sex: M
Vaccine: TDAP
Symptoms: Abdominal discomfort, Abdominal distension, Body temperature increased, Hypertension, Hypoaesthesia
Clinical narrative: Started with flu like symptoms, body aches and pain, nausea, low grade temp; condition persisted off and on; then in March noticed tender enlarged lymph node under left arm, along with vertigo, numbness left extremity, bloatiness and pressure RUQ, hypertension, blurred vision left eye; Started being seen by DR at that time; first visit showed that I also had low platelet count; started testing for everything from lymphoma to infectous diseases; continuing to be tested at this time but everything started after the Tdap vaccine administered; was placed on doxycycline for a week; also meds for hypertension; To this day condition remains the same along with increase muscle weakness.
Age: 56.0
Sex: M
Vaccine: TDAP
Symptoms: Influenza like illness, Lymph node pain, Lymphadenopathy, Muscular weakness, Nausea
Clinical narrative: Started with flu like symptoms, body aches and pain, nausea, low grade temp; condition persisted off and on; then in March noticed tender enlarged lymph node under left arm, along with vertigo, numbness left extremity, bloatiness and pressure RUQ, hypertension, blurred vision left eye; Started being seen by DR at that time; first visit showed that I also had low platelet count; started testing for everything from lymphoma to infectous diseases; continuing to be tested at this time but everything started after the Tdap vaccine administered; was placed on doxycycline for a week; also meds for hypertension; To this day condition remains the same along with increase muscle weakness.
Age: 56.0
Sex: M
Vaccine: TDAP
Symptoms: Nuclear magnetic resonance imaging brain abnormal, Pain, Platelet count decreased, Positron emission tomogram abnormal, Vertigo
Clinical narrative: Started with flu like symptoms, body aches and pain, nausea, low grade temp; condition persisted off and on; then in March noticed tender enlarged lymph node under left arm, along with vertigo, numbness left extremity, bloatiness and pressure RUQ, hypertension, blurred vision left eye; Started being seen by DR at that time; first visit showed that I also had low platelet count; started testing for everything from lymphoma to infectous diseases; continuing to be tested at this time but everything started after the Tdap vaccine administered; was placed on doxycycline for a week; also meds for hypertension; To this day condition remains the same along with increase muscle weakness.
Age: 56.0
Sex: M
Vaccine: TDAP
Symptoms: Vision blurred
Clinical narrative: Started with flu like symptoms, body aches and pain, nausea, low grade temp; condition persisted off and on; then in March noticed tender enlarged lymph node under left arm, along with vertigo, numbness left extremity, bloatiness and pressure RUQ, hypertension, blurred vision left eye; Started being seen by DR at that time; first visit showed that I also had low platelet count; started testing for everything from lymphoma to infectous diseases; continuing to be tested at this time but everything started after the Tdap vaccine administered; was placed on doxycycline for a week; also meds for hypertension; To this day condition remains the same along with increase muscle weakness.
Age: 15.0
Sex: F
Vaccine: HPV4
Symptoms: Exposure during pregnancy
Clinical narrative: This spontaneous prospective pregnancy report as received from a 15 year old female consumer. On 15-JUN-2014 the patient was vaccinated with GARDASIL of unknown strength dose and frequency. It was reported that on 16-JUN-2014 she found out she was pregnant, a day after receiving the GARDASIL. The gestational age was reported as 13 weeks. The patient became pregnant with LMP of 16-MAR-2015 (calculated with the formula, by subtracting  gestational age from the age of foetus) and the estimated due date EDD was of 21-DEC-2014. Initial exposure to GARDASIL was at 13 weeks. The pregnancy outcome was outcome pending. Additional information has been requested.
Sex: M
Vaccine: FLUX, FLUX
Symptoms: Anaphylactic reaction
Clinical narrative: Initial report was received on 31 July 2014 from a health care professional. A patient (date of birth not reported) had received on an unreported date an influenza vaccine and an unspecified amount of time later developed a near anaphylactic reaction. No further information reported. Outcome unknown. Note: influenza lot number, route, site and date of administration not reported. Documents held by sender: none.
Sex: F
Vaccine: HEPA, TTOX
Symptoms: Blood glucose abnormal, Latent autoimmune diabetes in adults
Clinical narrative: Information received from a consumer who is the patient on 29 July 2014. A female patient was vaccinated on a date "years ago" with HEPATITIS A ADULT VACCINE and a TETANUS VACCINE booster, manufacturers, route and site of administration not reported. On an unspecified date later she experienced diabetes type "one and a half". Her blood sugars were in the 300's before starting a treatment of LANTUS SOLOSTAR, date not specified. The patient's medical history and concomitant medications were not reported. The patient outcome is not recovered. Documents held by sender: None.
Sex: U
Vaccine: RV5
Symptoms: Incorrect storage of drug, No adverse event
Clinical narrative: This spontaneous report as received from a certified medical assistant refers to an unspecified number of patients of unknown demographics. No concurrent medications or medical history were provided. The medical assistant reported that those patients were administered with a doses of ROTATEQ that had been improperly stored (doses, indications, lot#, expiry dates unspecified) between 13-OCT-2013 and 13-NOV-2013. No concomitant medications were reported. No adverse effects were reported. This is one of several reports from the same source.  Additional information has been requested.