chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 11.0
Sex: F
Vaccine: HPV9, MNQ, TDAP
Symptoms: Nausea, Pallor, Posture abnormal
Clinical narrative: Client received 3 immunizations in this order: Tdap and MCV4 into right deltoid and HPV into left deltoid.  After the 3rd immune was administered client started to slump in her chair and all color drained from her face.  She was assisted to a lying position on the floor.  She was breathing but did not respond to questions asked for about 15-20 seconds.  She then stated that she felt like she had to throw up.  She was able to follow the command to breath deeply and within a few minutes the coloring started to return to her face.  She did not throw up. She remained in a supine position for about 15 minutes and then a sitting position for another 15 minutes before she was released.  She could not remember anything about the experience except for someone helping her to the floor.  She asked her guardian if she had fallen asleep.
Age: 34.0
Sex: F
Vaccine: HEP, TDAP
Symptoms: Injection site pain, Pain, Pain in extremity
Clinical narrative: Patient complaining of extreme soreness to her right arm and shoulder and now states that it hurts to move her arm.
Age: 18.0
Sex: M
Vaccine: MNQ
Symptoms: Dizziness, Loss of consciousness, Nausea, Pallor, Somnolence
Clinical narrative: Nausea, Dizzy/Lightheaded, then passed out, he was in a sitting position. Held him and tried to wake him by patting back, talking, moving him. He was still unconscious after around 3-4 minutes and looked more pale. Administered Epipen shot to left thigh and called EMS.  He opened his eyes but still groggy. Called his father while EMS was checking him. Father mentioned has fainted before. EMS checked vitals and everything okay.  Child mentioned has fainted twice before. Once when blood was drawn for blood work and again before IV was given for wisdom tooth removal. Child took sips of water while waiting for his father. Father arrived and waited until child felt well enough to walk.
Age: 18.0
Sex: M
Vaccine: MNQ
Symptoms: Unresponsive to stimuli
Clinical narrative: Nausea, Dizzy/Lightheaded, then passed out, he was in a sitting position. Held him and tried to wake him by patting back, talking, moving him. He was still unconscious after around 3-4 minutes and looked more pale. Administered Epipen shot to left thigh and called EMS.  He opened his eyes but still groggy. Called his father while EMS was checking him. Father mentioned has fainted before. EMS checked vitals and everything okay.  Child mentioned has fainted twice before. Once when blood was drawn for blood work and again before IV was given for wisdom tooth removal. Child took sips of water while waiting for his father. Father arrived and waited until child felt well enough to walk.
Age: 5.0
Sex: F
Vaccine: HEP, HEPA, MMR, VARCEL
Symptoms: Injection site erythema, Injection site induration, Injection site vesicles
Clinical narrative: Erythema, induration redness with small blisters around site. 10cm induration and 4cm area of more intense erythema with multiple vesicles notes.
Age: 1.26
Sex: M
Vaccine: DTAP, HIBV, MMR
Symptoms: Culture, Electroencephalogram, Febrile convulsion, Full blood count
Clinical narrative: Complex febrile seizure (history of same in past) eventual admission to hospital, of course unclear if related time course wise to immunizations.
Age: 11.0
Sex: F
Vaccine: HPVX, MEN, TDAP
Symptoms: Dizziness, Eye movement disorder, Fall, Pallor, Syncope
Clinical narrative: Became dizzy, eyes rolled up in head, fainted & fell to ground, became ghost white.
Age: 71.0
Sex: F
Vaccine: TDAP, TDAP
Symptoms: Bloody discharge, Culture, Erythema, Incisional drainage, Influenza like illness
Clinical narrative: She came back in on 6/3/16 with a cutaneous abscess of the right upper extremity thought to be at the injection site.  She reported that 2 days after getting the injection, she developed flu-like symptoms and noted a large red area over her arm that had since shrunk in size.  On approximately 6/1/16, she was in the shower and noted thick yellow bloody drainage from her arm.  She did not have fever or chills.  She applied triple antibiotic ointment and did hot compresses.
Age: 71.0
Sex: F
Vaccine: TDAP, TDAP
Symptoms: Subcutaneous abscess
Clinical narrative: She came back in on 6/3/16 with a cutaneous abscess of the right upper extremity thought to be at the injection site.  She reported that 2 days after getting the injection, she developed flu-like symptoms and noted a large red area over her arm that had since shrunk in size.  On approximately 6/1/16, she was in the shower and noted thick yellow bloody drainage from her arm.  She did not have fever or chills.  She applied triple antibiotic ointment and did hot compresses.
Age: 71.0
Sex: F
Vaccine: TDAP, TDAP
Symptoms: Influenza like illness, Injection site abscess, Injection site reaction, Purulent discharge
Clinical narrative: She came back in on 6/3/16 with a cutaneous abscess of the right upper extremity thought to be at the injection site.  She reported that 2 days after getting the injection, she developed flu-like symptoms and noted a large red area over her arm that had since shrunk in size.  On approximately 6/1/16, she was in the shower and noted thick yellow bloody drainage from her arm.  She did not have fever or chills.  She applied triple antibiotic ointment and did hot compresses.
Age: 11.0
Sex: F
Vaccine: HPV9, MNQ, TDAP
Symptoms: Injection site erythema, Injection site induration, Injection site mass, Injection site pain, Injection site pruritus
Clinical narrative: Began itching at injection site after vaccine was given; redness, swelling, & pain with hard lump at injection site.  Continued x 1 week; now has a small lump at site at this time.
Age: 11.0
Sex: F
Vaccine: HPV9, MNQ, TDAP
Symptoms: Injection site swelling
Clinical narrative: Began itching at injection site after vaccine was given; redness, swelling, & pain with hard lump at injection site.  Continued x 1 week; now has a small lump at site at this time.
Age: 84.0
Sex: F
Vaccine: PPV
Symptoms: Headache, Injection site inflammation, Pyrexia
Clinical narrative: Significant inflammation at the injection site and surrounding tissues extending from shoulder to elbow along with headache, and fever.
Age: 35.0
Sex: F
Vaccine: FLUX
Symptoms: Injected limb mobility decreased, Injection site pain, Rotator cuff syndrome
Clinical narrative: Upper left arm pain and immobility.
Age: 1.02
Sex: F
Vaccine: IPV
Symptoms: Rash generalised
Clinical narrative: Mosquito bite looking bumps all over.
Age: 1.54
Sex: F
Vaccine: HEPA
Symptoms: Body temperature increased, Seizure
Clinical narrative: Seizure on the way home in car.
Age: 5.0
Sex: M
Vaccine: DTAPIPV, MMRV
Symptoms: Injection site erythema, Injection site induration
Clinical narrative: Patient quickly developed a reaction to the ProQuad injection. 5 minutes after administration patient had a 1 in x 1 induration on his thigh, and a 1.5 in x 1.5 in red area. At the time of this report, area has still not resolved.
Age: 31.0
Sex: F
Vaccine: RAB
Symptoms: Arthralgia, Blepharospasm, Headache, Nausea, Paraesthesia
Clinical narrative: Per patient report via email: fever, wheezing, headaches, eye twitches, severe joint pain, tingling in feet, dizzy, nauseated.
Age: 31.0
Sex: F
Vaccine: RAB
Symptoms: Pyrexia, Wheezing
Clinical narrative: Per patient report via email: fever, wheezing, headaches, eye twitches, severe joint pain, tingling in feet, dizzy, nauseated.
Age: 28.0
Sex: F
Vaccine: FLU3
Symptoms: Injected limb mobility decreased, Injection site pain, Pain, Pain in extremity
Clinical narrative: Pain in right shoulder with decrease ROM and Pain with abduction and radiation of pain to right hand. Symptoms lasted four weeks.
Age: 71.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site erythema, Injection site pruritus, Injection site swelling
Clinical narrative: Redness, swelling, and itching around injection site. Entire upper arm reported by patient.
Age: 53.0
Sex: M
Vaccine: TDAP
Symptoms: Contusion, Swelling
Clinical narrative: SWELLING AND BRUISING.
Age: 14.0
Sex: F
Vaccine: FLU4, HPV9
Symptoms: Blood culture negative, CSF culture negative, Cerebral calcification, Computerised tomogram head abnormal, Culture urine negative
Clinical narrative: Patient presented to ER with respiratory failure & seizure like activity.
Age: 14.0
Sex: F
Vaccine: FLU4, HPV9
Symptoms: Electroencephalogram normal, Respiratory failure, Seizure like phenomena
Clinical narrative: Patient presented to ER with respiratory failure & seizure like activity.
Age: 0.5
Sex: F
Vaccine: DTAPIPVHIB, FLU3, HEP, PNC13, RV5
Symptoms: Autism, Dyspraxia, Encephalitis, Metabolic syndrome, Opisthotonus
Clinical narrative: It began with a back arching, high pitch scream, severe vomiting, inablility to breastfeed, high fever and unresponsiveness. After a visit to the ER after severe vomiting, we were told "virus" and "coincidence" and sent home with Tylenol.
Age: 0.5
Sex: F
Vaccine: DTAPIPVHIB, FLU3, HEP, PNC13, RV5
Symptoms: Pyrexia, Screaming, Selective eating disorder, Sensory processing disorder, Unresponsive to stimuli
Clinical narrative: It began with a back arching, high pitch scream, severe vomiting, inablility to breastfeed, high fever and unresponsiveness. After a visit to the ER after severe vomiting, we were told "virus" and "coincidence" and sent home with Tylenol.
Age: 0.5
Sex: F
Vaccine: DTAPIPVHIB, FLU3, HEP, PNC13, RV5
Symptoms: Viral infection, Vomiting
Clinical narrative: It began with a back arching, high pitch scream, severe vomiting, inablility to breastfeed, high fever and unresponsiveness. After a visit to the ER after severe vomiting, we were told "virus" and "coincidence" and sent home with Tylenol.
Age: 42.0
Sex: F
Vaccine: YF
Symptoms: Injection site erythema, Injection site swelling
Clinical narrative: Reported redness & swelling at injection site.  Advised to contact physician, apply ice and take Benadryl if not contraindicated.
Age: 4.0
Sex: M
Vaccine: DTAPIPV, MMR, VARCEL
Symptoms: Ear infection, Pyrexia, Rash generalised
Clinical narrative: Child developed fever and full body rash. His mother brought him to the clinic the next morning. (06/03/2016) Child was coping well and recovered with oral Benadryl. He had a follow up with Dr. (06/06/2016) after my visit and was treated for an ear infection. Rash was still present but improved.
Age: 0.4
Sex: F
Vaccine: JEV1
Symptoms: Irritability
Clinical narrative: Pt was irritable for about 7-10 minutes and then was rocked to sleep by the mother.
Age: 1.92
Sex: F
Vaccine: DTAP, HEPA
Symptoms: Asthma, Decreased appetite, Dyspnoea, Fatigue, Oxygen saturation decreased
Clinical narrative: Fever started about 24 hours from vaccination time.  Was around 104 F.  Cough started around 48 hours after.  Loss of appetite and extreme fatigue.    Illness progressed until 5/28.  On 5/28 she expirenced very labored breathing and was taken to the ER.  Oxygen level was only 86% and she was admitted to the hospital.  She could not keep her oxygen levels up and was oxygen for 4 days.  She now has to take breathing treatments twice day for "asthma".
Age: 1.92
Sex: F
Vaccine: DTAP, HEPA
Symptoms: Pyrexia
Clinical narrative: Fever started about 24 hours from vaccination time.  Was around 104 F.  Cough started around 48 hours after.  Loss of appetite and extreme fatigue.    Illness progressed until 5/28.  On 5/28 she expirenced very labored breathing and was taken to the ER.  Oxygen level was only 86% and she was admitted to the hospital.  She could not keep her oxygen levels up and was oxygen for 4 days.  She now has to take breathing treatments twice day for "asthma".
Age: 19.0
Sex: F
Vaccine: HEPA, HPV4, MNQ, TDAP
Symptoms: Blood test, Colonoscopy, Computerised tomogram, Endoscopy, Hypersensitivity
Clinical narrative: I have an on going life long immune system problem. Allergies formed, I lost 25 pounds in one year without effort or even trying to lose the weight. I cannot remember a day when I didn't feel sick!
Age: 19.0
Sex: F
Vaccine: HEPA, HPV4, MNQ, TDAP
Symptoms: Immune system disorder, Malaise, Weight decreased
Clinical narrative: I have an on going life long immune system problem. Allergies formed, I lost 25 pounds in one year without effort or even trying to lose the weight. I cannot remember a day when I didn't feel sick!
Age: 18.0
Sex: F
Vaccine: MNQ
Symptoms: Blood glucose, Dyskinesia, Syncope
Clinical narrative: Patient received Menactra Vaccine as per request. About 5 minutes post immunization, she had a syncopal episode and had jerking movements. She was assisted to supine position and vital signs obtained. EMS 911 was requested. Orthostatic BP performed. 92/58 mm Hg BS 100 mg/dl. Recovered spontaneously after 2 - 3 minutes.
Age: 70.0
Sex: F
Vaccine: PNC13
Symptoms: Erythema, Induration, Nodule, Skin warm, Swelling
Clinical narrative: Patient had a hard knot come up that was red, swollen and fevered. She said that she didn't notice it being that bad until someone saw it and said something.  She put ice on it and antibiotic ointment, by the time I saw it on 6/7 AM, the swelling was minimal and just a little redness.  Called the Dr and he told her to take Benadryl.  She seemed fine with that and said it was going down some already.
Age: 60.0
Sex: F
Vaccine: PPV
Symptoms: Arthralgia, Cellulitis, Dizziness, Fatigue, Headache
Clinical narrative: I had a fever of 102.4 the next day at 9am and ended in the emergency room. There I was given antibiotics and was found to have cellulitis. I also had whole body arthralgia, Headache, fatigue, muscle weakness, nausea, and dizziness.
Age: 60.0
Sex: F
Vaccine: PPV
Symptoms: Muscular weakness, Nausea, Pyrexia
Clinical narrative: I had a fever of 102.4 the next day at 9am and ended in the emergency room. There I was given antibiotics and was found to have cellulitis. I also had whole body arthralgia, Headache, fatigue, muscle weakness, nausea, and dizziness.
Age: 4.0
Sex: M
Vaccine: DTAPIPV, MMRV
Symptoms: Blister, Injection site erythema, Injection site warmth
Clinical narrative: Mother reports patient developed redness, warmth to injection site and pt also developed small cluster of vesicular like lesions anterior deltoid. No treatment given by mother. Healthcare provider (writer) saw pt today and observed warm, mildly erythematous left deltoid area, non tender to touch, child has full range of motion, <1cm cluster white vesicular like lesions anterior deltoid.
Age: 64.0
Sex: F
Vaccine: PPV, VARZOS
Symptoms: Erythema, Pyrexia, Swelling
Clinical narrative: Swelling, redness, fever saw MD who prescribed ice, elevation, ibuprofen and clindamycin (however pt did not fill clindamycin).
Age: 66.0
Sex: F
Vaccine: PNC13
Symptoms: Axillary mass, Burning sensation, Erythema, Lymphadenopathy, Pyrexia
Clinical narrative: Very red arm, Tender, burning, clavicle lymph nodes swollen, "baseball" lump under arm, feverish.
Age: 66.0
Sex: F
Vaccine: PNC13
Symptoms: Tenderness
Clinical narrative: Very red arm, Tender, burning, clavicle lymph nodes swollen, "baseball" lump under arm, feverish.
Age: 54.0
Sex: F
Vaccine: VARZOS
Symptoms: Joint swelling, Peripheral swelling
Clinical narrative: Swelling of bilateral ankles and feet.
Age: 0.41
Sex: M
Vaccine: DTAPHEPBIP, HIBV, PNC13, RV5
Symptoms: Rash
Clinical narrative: Rash on face, head, and stomach.
Age: 73.0
Sex: M
Vaccine: VARZOS
Symptoms: Dizziness, Feeling hot, Hyperhidrosis, Syncope
Clinical narrative: Per patients report: syncope, sweating profusely, and intense feeling of heat, sweating, and dizziness.
Age: 44.0
Sex: M
Vaccine: TD
Symptoms: Chills, Pain, Pain in extremity, Pyrexia
Clinical narrative: Fever, chills, generalized body aches, severe arm pain since Td injection. Saw another Dr was given KEFLEX.
Age: 86.0
Sex: F
Vaccine: PNC13
Symptoms: Pain in extremity
Clinical narrative: Patient experienced severe pain throughout entire arm which received injection. She required a prescription for ULTRACET to help with the pain.
Age: 64.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site erythema, Injection site pruritus, Injection site swelling
Clinical narrative: Injection site swelled up to size of an orange and was red and itchy (per pt); pt took MOTRIN and the swelling went down to pinpoint within 1-2 days.
Age: 14.0
Sex: M
Vaccine: MNQ
Symptoms: Dizziness, Hypotension, Pallor, Syncope
Clinical narrative: Pt fainted 5 min post injection, pt's BP was low and pt reported dizziness and pt was pale.
Sex: U
Vaccine: HIBV
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report was received from a licensed practitioner nurse, referring to a patient of unknown age and gender. The patient's medical history and concurrent conditions were not reported. On 16-MAY-2016, the patient was vaccinated with improperly stored dose of PEDVAXHIB lot # L042257 with expiry date on 17-AUG-2018 (strength, dose, route and anatomical location were not reported). Concomitant medications were not reported. No adverse effects were reported and no product quality complaint was involved. This is one of several reports received from the same reporter. Additional information has been requested.
Sex: U
Vaccine: HIBV
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report was received from a licensed practitioner nurse, referring to a patient of unknown age and gender. The patient's medical history and concurrent conditions were not reported. On 17-MAY-2016, the patient was vaccinated with improperly stored dose of PEDVAXHIB lot # L042257 with expiry date on 17-AUG-2018, (strength, dose, route and anatomical location were not reported). Concomitant medications were not reported. No adverse effects were reported and no product quality complaint was involved. This is one of several reports received from the same reporter. Additional information has been requested.
Age: 31.0
Sex: F
Vaccine: YF
Symptoms: Back pain, Chills, Injection site erythema, Injection site swelling, Injection site warmth
Clinical narrative: Received vaccine Tues am 5/31/16. Thursday felt muscle cramps neck and shoulders after driving 4 hours. Friday LBP with stiffness. Then fever, chills. Next tingling feet. Site: 1" red, mildly elevated, warm.
Age: 31.0
Sex: F
Vaccine: YF
Symptoms: Muscle spasms, Musculoskeletal stiffness, Paraesthesia, Pyrexia
Clinical narrative: Received vaccine Tues am 5/31/16. Thursday felt muscle cramps neck and shoulders after driving 4 hours. Friday LBP with stiffness. Then fever, chills. Next tingling feet. Site: 1" red, mildly elevated, warm.
Age: 1.0
Sex: F
Vaccine: HEPA, MMR, MMRV, PNC13
Symptoms: Extra dose administered, No adverse event
Clinical narrative: This spontaneous report has been received from a nurse practitioner referring to a 12 month old patient. The patient's current condition and medical history was not reported. On 19-MAY-2016, the patient was inadvertently vaccinated with the first dose of PROQUAD (lot # L044056, exp date 02-MAY-2017, dose 1) concomitant with first dose of M-M-R II (lot # L027591, exp date 23-JUL-2017, dose and route unknown). It was reported that the M-M-R II was vaccinated in opposite unspecified area. No adverse effects were reported. Additional information has been requested.
Sex: U
Vaccine: HIBV
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report was received from a licensed practitioner nurse, referring to a patient of unknown age and gender. The patient's medical history and concurrent conditions were not reported. On 16-MAY-2016, the patient was vaccinated with improperly stored dose of PEDVAXHIB lot # L042257 with expiry date on 17-AUG-2018, (strength, dose, route and anatomical location were not reported). Concomitant medications were not reported. No adverse effects were reported and no product quality complaint was involved. This is one of several reports received from the same reporter. Additional information has been requested.
Sex: U
Vaccine: HEPA
Symptoms: Extra dose administered, No adverse event
Clinical narrative: This spontaneous report was received from a registered nurse refers to a patient of unknown age and gender. The patient's pertinent medical history and concomitant medications were not reported. On 28-MAY-2016, the patient was inadvertently vaccinated with a third dose VAQTA. The patient completed the series several years ago. No adverse events were reported. This is one of the two reports received from the same reporter. Additional information has been requested.
Age: 17.0
Sex: F
Vaccine: HEP
Symptoms: Expired product administered, No adverse event
Clinical narrative: This spontaneous report was received from a healthcare worker (certified medical assistant) refers to a patient of unknown age. The medical history, concurrent condition and concomitant medications were not reported. On 26-MAY-2016, the patient was vaccinated with an expired dose of RECOMBIVAX HB lot # K005078, 01-APR-2016 intramuscular. No adverse effect was reported. Additional information has been requested.
Sex: F
Vaccine: HPV4
Symptoms: Adverse reaction
Clinical narrative: This solicited report was received from a consumer and refers to her friend's daughter - a female patient of unknown age enrolled in a market research. There was no information about the patient's concurrent conditions, concomitant therapies or medical history provided. On an unknown date, the patient was vaccinated with a dose of GARDASIL (dose, route of administration, lot # and expiration date were not reported). On an unknown date, the patient experienced "a horrible reaction". The reporter stated that because of this event she did not vaccinate her son with any HPV vaccine. The outcome of the event was not reported. The reporter considered the event to be related to GARDASIL. Additional information is not expected as there was no consent for follow up.
Sex: U
Vaccine: VARCEL
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: Information has been received from a pharmacist referring to unspecified patients of unknown age and gender. Information regarding the patients' medical history, concurrent conditions and concomitant medication were not provided. On unknown dates the patients were vaccinated with doses of improperly stored (at 24 Fahrenheit for 24 hours) VARIVAX (lot # L046888, expiration date 23-NOV-2017, dose and route unknown). There was no temperature excursions previously. No adverse effects were reported. This is one of the several reports received from the same reporter. Additional information has been requested.
Sex: M
Vaccine: VARZOS
Symptoms: Herpes zoster
Clinical narrative: This spontaneous report as received from a physician via company representative refers to a male patient of unknown age. No concurrent conditions, medical history, allergy/drug reactions and concomitant medications were reported. Approximately in 2016 (reported as couple days ago) the patient was vaccinated with ZOSTAVAX, 1 shot (lot# and expiry were not reported) subcutaneously. Approximately in 2016, the day after vaccination, the patient experienced shingles. The outbreak occurred on the same side as the injection site. The patient visited the doctor's office to seek medical attention. The outcome of shingles was reported as not recovered. The reporter did not provide the causality between the event and the suspect therapy. There were no product quality complaints (PQC) involved. Additional information has been requested.
Age: 26.0
Sex: F
Vaccine: VARZOS
Symptoms: Condition aggravated, Herpes zoster, Inappropriate schedule of drug administration
Clinical narrative: This spontaneous report was received from a physician refers to a 26 year old female patient. The patient's pertinent medical history included "intermittent" bronchitis and shingles. The patient had none drug reactions/allergies. On an unspecified date in March-2016, the patient was vaccinated with ZOSTAVAX to "prevent against recurrent shingles"; which is outside of the recommendations in the ZOSTAVAX prescribing information. None concomitant medication reported. On 20-MAY-2016, the patient developed "shingles again". The outcome of the event (patient developed "shingles again") was not recovered and outcome of the other event was unknown. The reporter did not provide any causality assessment between events and ZOSTAVAX. Additional information has been requested.
Sex: U
Vaccine: MMRV
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: Information has been received from a registered nurse referring to unspecified patients of unknown age and gender. Information regarding the patients' medical history, concurrent conditions and concomitant medication were not provided. On unknown dates the patients were inadvertently vaccinated with doses of improperly stored (7 Fahrenheit, cumulated time of 3 weeks) PROQUAD (lot # M010475, expiration date 01-SEP-2017). There were no temperature excursions previously. No adverse effects were reported. This is one of several reports received from the same reporter. Additional information is not expected since we have no consent to contact the nurse.
Sex: U
Vaccine: VARZOS
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: Information has been received from a pharmacist referring to unspecified patients of unknown age and gender. Information regarding the patients' medical history, concurrent medication were not provided. On unknown dates the patients were vaccinated with doses of improperly stored (at 24 Fahrenheit for 24 hours) ZOSTAVAX (lot # L040442 with expiration date 15-JAN-2017; lot # L046900 with expiration date 23-FEB-2017; dose and route unknown). There were no temperature excursions previously. No adverse effects were reported. This is one of the several reports received from the same reporter. Additional information has been requested.
Sex: U
Vaccine: HIBV
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report was received from a licensed practitioner nurse, referring to a patient of unknown age and gender. The patient's medical history and concurrent conditions were not reported. On 16-MAY-2016, the patient was vaccinated with improperly stored dose of PEDVAXHIB lot # L042257 with expiry date on 17-AUG-2018, (strength, dose, route and anatomical location were not reported). Concomitant medications were not reported. No adverse effects were reported and no product quality complaint was involved. Additional information has been requested.
Sex: U
Vaccine: VARCEL
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: Information has been received from a registered nurse referring to unspecified patients of unknown age and gender. Information regarding the patients' medical history, concurrent conditions and concomitant medication were not provided. On unknown dates the patents were inadvertently vaccinated with doses of improperly stored (7 Fahrenheit, cumulated time of 3 weeks) VARIVAX (lot # L031066, expiration date 18-AUG-2017, dose and route unknown). There were no temperature excursions previously. No adverse effects were reported. This is one of the several reports received from the same reporter. Additional information is not expected since we have no consent to contact the nurse.
Sex: U
Vaccine: HEP
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report was received from a nurse and refers to an unspecified patient of unknown age and gender. No information regarding the patient's pertinent medical history, drug reactions, allergies or concomitant therapies was provided. On 01-JUN-2016 (reported as today), the patient was vaccinated with improperly stored dose of RECOMBIVAX HB (lot # L040458, expiration date 04-FEB-2018, exact dose and route of administration were not reported). The reason of the call was temperature alarm received via Digital Data Logger. It was reported that the vaccine was exposed to temperature of 49.8 degree Fahrenheit for 30 minutes before administration to the patient. No previous temperature excursion was reported. No adverse effects were reported. This is one of the several reports received from the same source. Additional information has been requested.
Sex: U
Vaccine: HIBV
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report was received from a licensed practitioner nurse, referring to a patient of unknown age and gender. The patient's medical history and concurrent conditions were not reported. On 16-MAY-2016, the patient was vaccinated with improperly stored dose of PEDVAXHIB lot # L042257 with expiry date on 17-AUG-2018, (strength, dose, route and anatomical location were not reported). Concomitant medications were not reported. No adverse effects were reported and no product quality complaint was involved. This is one several reports received from the same reported. Additional information has been requested.
Sex: U
Vaccine: HIBV
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report was received from a licensed practitioner nurse, referring to a patient of unknown age and gender. The patient's medical history and concurrent conditions were not reported. On 16-MAY-2016, the patient was vaccinated with improperly stored dose of PEDVAXHIB lot# L042257 with expiry date on 17-AUG-2018, (strength, dose, route and anatomical location were not reported). Concomitant medications were not reported. No adverse effects were reported and no product quality complaint was involved. Additional information has been requested.
Sex: U
Vaccine: PPV
Symptoms: Expired product administered, No adverse event
Clinical narrative: This spontaneous report as received from a pharmacist refers to a patient of unknown age and gender. There was no information about the patient's concurrent conditions, concomitant therapies or medical history provided. On 01-JUN-2016, the patient was vaccinated with an expired, properly stored dose of PNEUMOVAX 23 lot # K019561, expiration date 20-APR-2016 (dose and route of administration were not reported). There was no adverse effect reported. Additional information has been requested.
Age: 72.0
Sex: F
Vaccine: VARZOS, VARZOS
Symptoms: Herpes zoster, Rash vesicular
Clinical narrative: This spontaneous report was received from a physician via a company representative and refers to a 79 year old female patient with multiple unspecified chronic conditions. In approximately July 2009, the patient was vaccinated with 1 dose of ZOSTAVAX (lot # and route were not provided). The patient sought medical attention by going into the physician's office on 19-MAY-2016 with a "vesicular patch in the lower lumbar area" and was diagnosed with a case of shingles. The patient was given a course of treatment with VALTREX. The physician had not heard from the patient since the office visit. The outcome of the event was unknown. The relatedness between the event and ZOSTAVAX was not reported. Additional information has been requested.
Age: 72.0
Sex: F
Vaccine: VARZOS, VARZOS
Symptoms: Body temperature increased, Herpes zoster, Pain, Rash vesicular, Renal failure
Clinical narrative: This spontaneous report was received from a physician via a company representative and refers to a 79 year old female patient with multiple unspecified chronic conditions. In approximately July 2009, the patient was vaccinated with 1 dose of ZOSTAVAX (lot # and route were not provided). The patient sought medical attention by going into the physician's office on 19-MAY-2016 with a "vesicular patch in the lower lumbar area" and was diagnosed with a case of shingles. The patient was given a course of treatment with VALTREX. The physician had not heard from the patient since the office visit. The outcome of the event was unknown. The relatedness between the event and ZOSTAVAX was not reported. Additional information has been requested.
Age: 72.0
Sex: F
Vaccine: VARZOS, VARZOS
Symptoms: Skin lesion
Clinical narrative: This spontaneous report was received from a physician via a company representative and refers to a 79 year old female patient with multiple unspecified chronic conditions. In approximately July 2009, the patient was vaccinated with 1 dose of ZOSTAVAX (lot # and route were not provided). The patient sought medical attention by going into the physician's office on 19-MAY-2016 with a "vesicular patch in the lower lumbar area" and was diagnosed with a case of shingles. The patient was given a course of treatment with VALTREX. The physician had not heard from the patient since the office visit. The outcome of the event was unknown. The relatedness between the event and ZOSTAVAX was not reported. Additional information has been requested.
Age: 1.82
Sex: M
Vaccine: HEPA
Symptoms: Activated partial thromboplastin time, Blood thyroid stimulating hormone, C-reactive protein, Differential white blood cell count, Erythema
Clinical narrative: All of the symptoms per mother had not been observed in clinic or in ER prior. Pt mother stated that at 6 PM on 04/26/2016, pt had swollen lip and red ear. Pt also having sore throat. Pt then was fine, resolved on its own. Pt the next day went to dentist and they recorded high blood pressure. Pt then went to ER, pt was fine in ER. Pt then had yellowing of feet. On examination in clinic on 04/27/2016 had no swelling, no resp dist, pt's alert and quite playful, no rash noted and pt w/no redness, no swelling at the site of the injection. No warmth at the site of the injection. Will check labs.
Age: 1.82
Sex: M
Vaccine: HEPA
Symptoms: Full blood count, Hypertension, Lip swelling, Liver function test, Metabolic function test
Clinical narrative: All of the symptoms per mother had not been observed in clinic or in ER prior. Pt mother stated that at 6 PM on 04/26/2016, pt had swollen lip and red ear. Pt also having sore throat. Pt then was fine, resolved on its own. Pt the next day went to dentist and they recorded high blood pressure. Pt then went to ER, pt was fine in ER. Pt then had yellowing of feet. On examination in clinic on 04/27/2016 had no swelling, no resp dist, pt's alert and quite playful, no rash noted and pt w/no redness, no swelling at the site of the injection. No warmth at the site of the injection. Will check labs.
Age: 1.82
Sex: M
Vaccine: HEPA
Symptoms: Oropharyngeal pain, Prothrombin time, Thyroxine free
Clinical narrative: All of the symptoms per mother had not been observed in clinic or in ER prior. Pt mother stated that at 6 PM on 04/26/2016, pt had swollen lip and red ear. Pt also having sore throat. Pt then was fine, resolved on its own. Pt the next day went to dentist and they recorded high blood pressure. Pt then went to ER, pt was fine in ER. Pt then had yellowing of feet. On examination in clinic on 04/27/2016 had no swelling, no resp dist, pt's alert and quite playful, no rash noted and pt w/no redness, no swelling at the site of the injection. No warmth at the site of the injection. Will check labs.
Sex: U
Vaccine: HPV4
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report was received from a nurse practitioner regarding a patient of unknown demography. The patient's concurrent conditions, medical history and concomitant medications were not reported. On 31-MAY-2016, the patient was vaccinated with one dose of improperly stored GARDASIL (route unknown) lot # K008931 with expiration date of 04-MAR-2017. The vaccine was exposed to a temperature of 8 degree Celsius for 80 hours. Digital data logger was involved. There was no previous temperature excursion. No adverse effects were reported. Additional information has been requested.
Sex: U
Vaccine: VARCEL
Symptoms: No adverse event, Wrong drug administered
Clinical narrative: This spontaneous report was received from a nurse practitioner refers to a patient of unknown age and gender. The patient's pertinent medical history and concomitant medications were not reported. on 01-JUN-2016, the patient was inadvertently administered a dose of VARIVAX (Lot # and expiry date were not reported). This patient was intended to receive a dose of ZOSTAVAX (no dose of ZOSTAVAX was administered). It was confirmed that no product confusion occurred. No adverse effects were reported. Additional information has been requested.
Sex: U
Vaccine: HEPA
Symptoms: Extra dose administered, No adverse event
Clinical narrative: This spontaneous report was received from a registered nurse refers to a patient of unknown age and gender. The patient's pertinent medical history and concomitant medications were not reported. On 28-MAY-2016, the patient was inadvertently vaccinated with a third dose of VAQTA. The patient completed the series several years ago. No adverse events were reported. This is one of the two reports received form the same reporter. Additional information has been requested.
Sex: M
Vaccine: VARCEL
Symptoms: Arthropod bite, Body temperature increased, Skin lesion, Varicella post vaccine
Clinical narrative: This spontaneous report was received from a physician via a company representative referring to a 17 month old female patient. The patient's concurrent conditions and medical history were not provided. On 10-MAY-2016 the patient was vaccinated with VARIVAX 1350 U, (lot # L041204, expiration date 20-OCT-2017, subcutaneously. There was no concomitant medication reported. On an unspecified date in 2016, the patient developed chickenpox. It was also reported that on 29-MAY-2016 the patient went to the emergency room and was diagnosed with insect bites. The patient had elevated temperature of 99.9 (units not provided) on 29-MAY-2016 and 30-MAY-2016. It was also mentioned that the patient had approximately 20 lesions across arms and back. The outcome of insect bites and chickenpox was reported as not recovered. The causal relationship between the events and therapy with VARIVAX was not reported. Additional information has been requested.
Age: 63.0
Sex: M
Vaccine: VARZOS, VARZOS
Symptoms: Limb discomfort, Mobility decreased, Paraesthesia
Clinical narrative: This spontaneous report was received from a pharmacist, and refers to a 63 year old male patient. The patient did not have any medical history, concurrent conditions or drug reactions/allergies. On 02-JUN-2016, the patient was vaccinated with a dose of ZOSTAVAX subcutaneously in the arm (unspecified; dose was not reported), lot # L037791 with expiration date of 30-DEC-2016. The patient was not taking any concomitant medications. It was reported that the patient went to his home and fell asleep after the vaccination. Later, on an unspecified date in June 2016, when the patient awoke, the arm where he received the vaccine was "tingling and numb". Additionally, his arm felt heavy and was unable to move it below the wrist. Therefore, the patient called his pharmacist and was advised to go to the local emergency room (ER) of a hospital. However, the reporter did not know if the patient went to the ER. No intervention to prevent serious criteria was performed. No laboratory diagnostic studies were performed. No product quality complaint was involved. At the time of reporting, the outcome of all above mentioned events was unknown. Additionally, the relatedness between the events and the suspect therapy was not provided by the reporter. Additional information has been requested.
Age: 63.0
Sex: M
Vaccine: VARZOS, VARZOS
Symptoms: Hypoaesthesia, Mobility decreased, Skin warm
Clinical narrative: This spontaneous report was received from a pharmacist, and refers to a 63 year old male patient. The patient did not have any medical history, concurrent conditions or drug reactions/allergies. On 02-JUN-2016, the patient was vaccinated with a dose of ZOSTAVAX subcutaneously in the arm (unspecified; dose was not reported), lot # L037791 with expiration date of 30-DEC-2016. The patient was not taking any concomitant medications. It was reported that the patient went to his home and fell asleep after the vaccination. Later, on an unspecified date in June 2016, when the patient awoke, the arm where he received the vaccine was "tingling and numb". Additionally, his arm felt heavy and was unable to move it below the wrist. Therefore, the patient called his pharmacist and was advised to go to the local emergency room (ER) of a hospital. However, the reporter did not know if the patient went to the ER. No intervention to prevent serious criteria was performed. No laboratory diagnostic studies were performed. No product quality complaint was involved. At the time of reporting, the outcome of all above mentioned events was unknown. Additionally, the relatedness between the events and the suspect therapy was not provided by the reporter. Additional information has been requested.
Sex: U
Vaccine: HPV9
Symptoms: Inappropriate schedule of drug administration, No adverse event
Clinical narrative: This spontaneous report was received from a licensed practical nurse and refers to a patient of unknown age and gender. The patient's concurrent conditions and medical history were not provided. It was reported that, on 12-MAY-2015, the patient was vaccinated with a first dose of GARDASIL Lot # reported as L013522, expiry date 13-SEP-2016 (dose, route and anatomical site of injection were not reported). The second dose of GARDASIL Lot # L001442, expiry date 04-NOV-2015, (dose, route and anatomical site of injection were not reported) was received on 16-JUN-2015. The third dose of GARDASIL Lot # K016966, expiry date 17-OCT-2017 (dose, route and anatomical site of injection were not reported), was received on 17-NOV-2015. Later, on 20-MAY-2016, the patient received a dose of GARDASIL 9 Lot # L048459, expiry date 01-JUN-2018 (lot number, dose, route and anatomical site of injection were not reported). Concomitant therapies were not provided. No adverse effects were reported. No product quality complain (PQC) was involved. Lot number L013522 is an invalid lot number for quadrivalent human papillomavirus (types 6, 11, 16, 18) recomb. vaccine.  Additional information has been requested.
Age: 13.0
Sex: F
Vaccine: HPV4
Symptoms: Alopecia
Clinical narrative: This spontaneous report was received from a certified medical assistant via a company representative and refers to a 13 year old female patient. The patient's medical history included eczema and other unspecified skin conditions. The patient's concurrent conditions were not provided. On an unknown date, the patient was vaccinated with a first dose of GARDASIL lot # L033347 (also reported as LO33347), (expiry date, dose and anatomical site of injection were not reported) and then, on 21-DEC-2015, the patient received her second dose, lot # L039066 (also reported as LO39066), (expiry date, dose and anatomical site of injection were not reported). Concomitant therapies were not provided. On an unknown date, after receiving the second dose of GARDASIL the patient experienced hair loss. The patient spoke to the physician and an unspecified blood work was performed (result were not available). In addition, an unspecified treatment for alopecia was given, however, the event did not improve. It was also reported that the therapy was discontinued. No product quality complain (PQC) was involved. At the time of reporting, the outcome of alopecia was not recovered. The reporter did not provide a causality assessment between the event and the GARDASIL. Additional information is not expected, since the reporter did not allow further contact for follow-up.
Age: 0.6
Sex: U
Vaccine: HPV4
Symptoms: Drug administered to patient of inappropriate age, No adverse event
Clinical narrative: This spontaneous report was received from a nurse practitioner and refers to a 7 month 22 days old patient of unknown gender. The patient's concurrent conditions and medical history were not provided. On 20-MAY-2016, the patient was inadvertently vaccinated with dose of GARDASIL lot # L035105, expiry date 14-MAY-2017 (dose, administration route and anatomical site of injections were not reported). Concomitant therapies were not provided. No adverse effects were reported. No product quality complain (PQC) was involved. Additional information has been requested.
Sex: U
Vaccine: PPV
Symptoms: Vaccination failure
Clinical narrative: This spontaneous report was received from a consumer of unknown age and gender referring to an unconfirmed number of patients. Information about the patient's pertinent medical history and drug reactions/allergies was not reported. The reporter informed that all about shingles was good. But, poor people and low income can not afford it and a security social program does not cover vaccinations for much of anything other than flu and pneumonia (manufacturer unknown) which also do not work. Information about dose, frequency, route of administration, lot # and expiration date were not provided. At the time of reporting, the outcome of the vaccination failure and its relatedness with pneumococcal vaccine, were unknown. Additional information is not expected as no reporter details were provided.
Sex: U
Vaccine: VARZOS
Symptoms: Extra dose administered, Inappropriate schedule of drug administration, No adverse event
Clinical narrative: This spontaneous report as received from a medical assistant via a company representative refers to patient of unknown age and gender. The patient's medical history, concurrent conditions and concomitant medications were not reported. In approximately May 2015, (reported as one year ago), the patient was vaccinated with the first dose of ZOSTAVAX (dose, frequency, lot # and expiration date were not reported). Then, on an unknown date (reported as a couple of months ago), the patient was re-vaccinated with the second dose of ZOSTAVAX (dose, frequency, lot # and expiration date were not reported). The patient did not report any extraneous symptoms due to revaccination. The patient did not seek medical attention and no treatment was given for the adverse event. Additional information is not expected as the physician did not wish to be contacted.
Age: 18.0
Sex: F
Vaccine: MENB
Symptoms: Injected limb mobility decreased, Lethargy, Pain, Pyrexia, Skin warm
Clinical narrative: The arm/area where vaccine was given was very painful, not able to move arm, very achy, lethargic, feverish warm to the touch.
Age: 18.0
Sex: F
Vaccine: MENB
Symptoms: Vaccination site pain
Clinical narrative: The arm/area where vaccine was given was very painful, not able to move arm, very achy, lethargic, feverish warm to the touch.
Age: 18.0
Sex: F
Vaccine: MENB
Symptoms: Lethargy, Pain, Pyrexia, Skin warm
Clinical narrative: Feverish, warm to the touch, achy, lethargic.
Sex: U
Vaccine: VARZOS
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report was received from a pharmacist referring to a patient of unknown age and gender. Information about the patient's medical history and concurrent conditions was not provided. On 16-MAY-2016, the patient was vaccinated with an improperly stored dose of ZOSTAVAX Lot numbers: L033311/expiration date: 01-DEC-2016 and L046893/Expiration date: 23-FEB-2017 (administration route was not provided). No concomitant therapies were reported. No adverse events were reported. Excursion data: Temperature no warmer than 46F, Time frame: 63.5 Additional information is not expected, since there was no consent to contact the responsible physician.
Age: 13.0
Sex: M
Vaccine: HPV4
Symptoms: Abdominal pain, Electroencephalogram, Imaging procedure, Loss of consciousness, Seizure
Clinical narrative: Abdominal pain, passed out, had a seizure.
Age: 56.0
Sex: F
Vaccine: MMR
Symptoms: Pruritus
Clinical narrative: 10-11 hours after receiving MMR vaccine patient states she had severe itching at bottom of feet and palms of her hands then moving into her legs and arms. No difficulty breathing, wheezing, no chest tightness, no swelling of tongue or throat, no dizziness or weakness, no fever, no rash.
Age: 88.0
Sex: M
Vaccine: PPV
Symptoms: Erythema, Induration, Skin warm, Swelling
Clinical narrative: Right arm with erythema and swelling. Area is warm to touch. Erythema is 28 cm x 15 cm wide exceeds about elbow and below site injection. Area right around injection site has induration and measures about 5 cm.