chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 11.0
Sex: F
Vaccine: HPV9, MNQ, TDAP
Symptoms: Lip haemorrhage, Musculoskeletal stiffness, Pain in extremity, Swelling face, Syncope
Clinical narrative: Event occurred at approx. 4:00 pm. Patient received the above vaccines and upon leaving clinic room just complained of a sore arm. Mother ran back to clinic from the outside motioning for help. A bystander witnessed pt. stiffen up and collapse to the ground. She had a bump on her forehead and lip was bleeding. Pt. was transported to hospital for evaluation. Ice pack was applied to head.
Age: 15.0
Sex: M
Vaccine: HPV9
Symptoms: Body temperature increased, Headache
Clinical narrative: Temp 102 Headache for 1 1/2 day. 3/29/17 AM - 3/30/17 AM resolved by afternoon.
Age: 11.0
Sex: F
Vaccine: HPV9, MNQ
Symptoms: Eye movement disorder, Foaming at mouth, Hypotonia, Moaning, Musculoskeletal stiffness
Clinical narrative: After giving HPV9 in (R) deltoid pt appeared to have stiffened up her arms/flexed then started groaning, foaming at the mouth and then went limp/eyes were staring at first then started to roll towards back of head.
Age: 11.0
Sex: F
Vaccine: HPV9, MNQ
Symptoms: Staring
Clinical narrative: After giving HPV9 in (R) deltoid pt appeared to have stiffened up her arms/flexed then started groaning, foaming at the mouth and then went limp/eyes were staring at first then started to roll towards back of head.
Age: 16.0
Sex: F
Vaccine: HPV9, MNQ
Symptoms: Crying, Dizziness, Pain, Pain in extremity
Clinical narrative: Patient reported to parent that she felt full body pain, down to her legs. Also felt dizzy. Was crying.
Age: 38.0
Sex: U
Vaccine: PPV
Symptoms: Allergy test, Chills, Injection site induration, Pain, Pyrexia
Clinical narrative: Swelling, pain, hot to touch, chills, fever, kept awake at night, hard at injection site.
Age: 38.0
Sex: U
Vaccine: PPV
Symptoms: Skin warm, Swelling
Clinical narrative: Swelling, pain, hot to touch, chills, fever, kept awake at night, hard at injection site.
Age: 11.0
Sex: M
Vaccine: HPV4, MMRV, MNQ, TDAP
Symptoms: Injection site erythema, Injection site swelling, Injection site warmth
Clinical narrative: Had large area of redness, warmth, and swelling around injection site. Started 1 day after immunization was admin. BENADRYL as directed. R Arm.
Age: 14.0
Sex: F
Vaccine: HPV9
Symptoms: Blood glucose normal, Head injury, Neurological examination normal, Syncope
Clinical narrative: Pt presented for a well-child visit. Normal physical and neurologic examination. Pt received GARDASIL 9 in the left deltoid. Approximately 2-3 minutes after vaccination Pt was sitting on exam table slumped over (syncope) and hit her head on the table. Event was approx. 2 min duration.
Age: 76.0
Sex: F
Vaccine: TD
Symptoms: Pain, Swelling
Clinical narrative: Swelling and achy 2 days later.
Age: 4.0
Sex: F
Vaccine: DTAP, IPV, MMR, VARCEL
Symptoms: No adverse event
Clinical narrative: No signs or symptoms at this time.
Sex: U
Vaccine: VARCEL
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. No information about the patient's medical history, concurrent conditions, drug reactions or allergies and concomitant therapies was provided. On 10-JAN-2017 at 13:21, the patient was vaccinated with an improperly stored VARIVAX (lot # M031969) for prophylaxis (expiration date, dose and route of administration were not reported). It was reported that the vaccine underwent previous temperature excursions, but the number of previous excursions, time frames and values of incorrect temperature were unknown. A digital data logger was used. No adverse effects were reported. Product quality complaint was not involved. This is one of several reports received from the same reporter. Additional information has been requested.; Sender's Comments: US-009507513-1701USA008441: US-009507513-1704USA000389: US-009507513-1704USA000390: US-009507513-1704USA000391: US-009507513-1704USA000392: US-009507513-1704USA000393: US-009507513-1704USA000394: US-009507513-1704USA000395: US-009507513-1704USA000396: US-009507513-1704USA000397: US-009507513-1704USA000398: US-009507513-1704USA000399: US-009507513-1704USA000400: US-009507513-1704USA000401: US-009507513-1704USA000402: US-009507513-1704USA000403: US-009507513-1704USA000404: US-009507513-1704USA000405: US-009507513-1704USA000406: US-009507513-1704USA000407: US-009507513-1704USA000408: US-009507513-1704USA000409: US-009507513-1704USA000410: US-009507513-1704USA000411: US-009507513-1704USA000412: US-009507513-1704USA000413: US-009507513-1704USA000414: US-009507513-1704USA000415: US-009507513-1704USA000416: US-009507513-1704USA000417: US-009507513-1704USA000418: US-009507513-1704USA000419: US-009507513-1704USA000420: US-009507513-1704USA000421: US-009507513-1704USA000422: US-009507513-1704USA000423: US-009507513-1704USA000424: US-009507513-1704USA000425: US-009507513-1704USA000426: US-009507513-1704USA000427: US-009507513-1704USA000428: US-009507513-1704USA000429: US-009507513-1704USA000430: US-009507513-1704USA000431: US-009507513-1704USA000432: US-009507513-1704USA000433: US-009507513-1704USA000434: US-009507513-1704USA000435: US-009507513-1704USA000436: US-009507513-1704USA000437: US-009507513-1704USA000438: US-009507513-1704USA000439: US-009507513-1704USA000441: US-009507513-1704USA000442: US-009507513-1704USA000443: US-009507513-1704USA000444: US-009507513-1704USA000445: US-009507513-1704USA000446: US-009507513-1704USA000447: US-009507513-1704USA000448: US-009507513-1704USA000449: US-009507513-1704USA000450: US-009507513-1704USA000451: US-009507513-1704USA000452: US-009507513-1704USA000453: US-009507513-1704USA000454: US-009507513-1704USA000455: US-009507513-1704USA000456: US-009507513-1704USA000457.
Sex: U
Vaccine: VARCEL
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. No information about the patient's medical history, concurrent conditions, drug reactions or allergies and concomitant therapies was provided. On 09-FEB-2017 at 14:07, the patient was vaccinated with an improperly stored VARIVAX (lot # M031969) for prophylaxis (expiration date, dose and route of administration were not reported). It was reported that the vaccine underwent previous temperature excursions, but the number of previous excursions, time frames and values of incorrect temperature were unknown. A digital data logger was used. No adverse effects were reported. Product quality complaint was not involved. This is one of several reports received from the same reporter. Additional information has been requested.; Sender's Comments: US-009507513-1701USA008441: US-009507513-1704USA000389: US-009507513-1704USA000390: US-009507513-1704USA000391: US-009507513-1704USA000392: US-009507513-1704USA000393: US-009507513-1704USA000394: US-009507513-1704USA000395: US-009507513-1704USA000396: US-009507513-1704USA000397: US-009507513-1704USA000398: US-009507513-1704USA000399: US-009507513-1704USA000400: US-009507513-1704USA000401: US-009507513-1704USA000402: US-009507513-1704USA000403: US-009507513-1704USA000404: US-009507513-1704USA000405: US-009507513-1704USA000406: US-009507513-1704USA000407: US-009507513-1704USA000408: US-009507513-1704USA000409: US-009507513-1704USA000410: US-009507513-1704USA000411: US-009507513-1704USA000412: US-009507513-1704USA000413: US-009507513-1704USA000414: US-009507513-1704USA000415: US-009507513-1704USA000416: US-009507513-1704USA000417: US-009507513-1704USA000418: US-009507513-1704USA000419: US-009507513-1704USA000420: US-009507513-1704USA000421: US-009507513-1704USA000422: US-009507513-1704USA000423: US-009507513-1704USA000424: US-009507513-1704USA000425: US-009507513-1704USA000426: US-009507513-1704USA000427: US-009507513-1704USA000428: US-009507513-1704USA000429: US-009507513-1704USA000430: US-009507513-1704USA000431: US-009507513-1704USA000432: US-009507513-1704USA000433: US-009507513-1704USA000434: US-009507513-1704USA000435: US-009507513-1704USA000436: US-009507513-1704USA000437: US-009507513-1704USA000438: US-009507513-1704USA000439: US-009507513-1704USA000440: US-009507513-1704USA000442: US-009507513-1704USA000443: US-009507513-1704USA000444: US-009507513-1704USA000445: US-009507513-1704USA000446: US-009507513-1704USA000447: US-009507513-1704USA000448: US-009507513-1704USA000449: US-009507513-1704USA000450: US-009507513-1704USA000451: US-009507513-1704USA000452: US-009507513-1704USA000453: US-009507513-1704USA000454: US-009507513-1704USA000455: US-009507513-1704USA000456: US-009507513-1704USA000457.
Sex: M
Vaccine: VARCEL
Symptoms: Discomfort, Erythema, Herpes zoster, Laboratory test, Rash
Clinical narrative: Information has been received from the authors in a published literature article, refers to a 18 month old boy who presented with herpes zoster. The authors described an atypical presentation of a common clinical entity. The patient presented to the emergency department with a rash on the left lower extremity. He was fully vaccinated, with routine vaccines at 12 months of age administered in the left thigh. On an unspecified date, the patient was vaccinated with VARIVAX in the left thigh (lot# and dosing details unspecified). He was also vaccinated with influenza vaccine, 1 week prior to the presentation in the left buttock, after which his parents noted a red patch near the site of vaccination. The patch became raised and spread down the left thigh over the course of several days. The rash did not bleed, ulcerate, weep, or appear itchy or painful, though the patient did seem uncomfortable when getting dressed. He had no known sick contacts at day care, exposure to herpes simplex virus, or exposure to new topical products or clothing. His pediatrician prescribed cephalexin and mupirocin for a presumed cutaneous bacterial infection. The eruption continued to spread down his left thigh over the next 2 days, at which point the pediatrician advised the family to go to the emergency department. On examination, the boy was afebrile and well-appearing. There were multiple discrete clusters of monomorphic pink to violaceous papulo-vesicles with surrounding erythema scattered across the left buttock, thigh, and upper calf, some with central punctate hemorrhagic crust. The lesions were non-tender. There were no skin lesions elsewhere. A test was performed. A diagnosis of herpes zoster was made. Because the patient's eruption was asymptomatic and improving by the time that test results were available, treatment with acyclovir was deferred. The grouped papulovesicles in a unilateral L3-L5 distribution involving the same extremity in which the VARIVAX was administered raised suspicion for herpes zoster in this patient. Additional information has been requested.
Sex: M
Vaccine: VARCEL
Symptoms: Rash papular, Scab, Skin lesion, Swelling
Clinical narrative: Information has been received from the authors in a published literature article, refers to a 18 month old boy who presented with herpes zoster. The authors described an atypical presentation of a common clinical entity. The patient presented to the emergency department with a rash on the left lower extremity. He was fully vaccinated, with routine vaccines at 12 months of age administered in the left thigh. On an unspecified date, the patient was vaccinated with VARIVAX in the left thigh (lot# and dosing details unspecified). He was also vaccinated with influenza vaccine, 1 week prior to the presentation in the left buttock, after which his parents noted a red patch near the site of vaccination. The patch became raised and spread down the left thigh over the course of several days. The rash did not bleed, ulcerate, weep, or appear itchy or painful, though the patient did seem uncomfortable when getting dressed. He had no known sick contacts at day care, exposure to herpes simplex virus, or exposure to new topical products or clothing. His pediatrician prescribed cephalexin and mupirocin for a presumed cutaneous bacterial infection. The eruption continued to spread down his left thigh over the next 2 days, at which point the pediatrician advised the family to go to the emergency department. On examination, the boy was afebrile and well-appearing. There were multiple discrete clusters of monomorphic pink to violaceous papulo-vesicles with surrounding erythema scattered across the left buttock, thigh, and upper calf, some with central punctate hemorrhagic crust. The lesions were non-tender. There were no skin lesions elsewhere. A test was performed. A diagnosis of herpes zoster was made. Because the patient's eruption was asymptomatic and improving by the time that test results were available, treatment with acyclovir was deferred. The grouped papulovesicles in a unilateral L3-L5 distribution involving the same extremity in which the VARIVAX was administered raised suspicion for herpes zoster in this patient. Additional information has been requested.
Age: 68.0
Sex: F
Vaccine: PPV
Symptoms: Nerve injury
Clinical narrative: Nerve damage to Left arm. 4 rxs for pain med/steroid physical therapy.
Age: 4.0
Sex: F
Vaccine: DTAPIPV, MMRV
Symptoms: Joint swelling
Clinical narrative: (L) shoulder swollen.
Age: 16.0
Sex: F
Vaccine: HPV9, MEN, MENB
Symptoms: Injection site bruising, Injection site erythema, Injection site pain, Injection site swelling
Clinical narrative: Rt arm has a red swollen area at site of injection, and a bruise. C/O pain at site.
Age: 22.0
Sex: M
Vaccine: TYP
Symptoms: Anxiety, Diarrhoea, Dysphagia, Dyspnoea, Local swelling
Clinical narrative: He reports with his first Typhoid (ViCPS) dose on 2 September 2014 he developed large local swelling within 10-15 minutes that lasted for 1-2 days prior to resolving. He denies generalized cutaneous, constitutional, and systemic symptoms with this dose. He received his second Typhoid dose (booster) on 2 September 2016 while deployed and 5-10 minutes later he developed local itching and swelling which progressed over the next several hours to affect his entire upper extremity and chest. He was anxious due to the worsening swelling and reports feeling that his throat was swelling causing difficulty swallowing. He admits to feeling anxious, possibly panicking, and thinks this may have caused him to have transient shortness of breath. He denies systemic symptoms but had diarrhea for several days after receiving the vaccine. He took Benadryl with resolution of his laryngeal symptoms; the swelling affecting his arm lasted for 3-4 days.
Age: 22.0
Sex: M
Vaccine: TYP
Symptoms: Peripheral swelling, Pharyngeal oedema, Pruritus
Clinical narrative: He reports with his first Typhoid (ViCPS) dose on 2 September 2014 he developed large local swelling within 10-15 minutes that lasted for 1-2 days prior to resolving. He denies generalized cutaneous, constitutional, and systemic symptoms with this dose. He received his second Typhoid dose (booster) on 2 September 2016 while deployed and 5-10 minutes later he developed local itching and swelling which progressed over the next several hours to affect his entire upper extremity and chest. He was anxious due to the worsening swelling and reports feeling that his throat was swelling causing difficulty swallowing. He admits to feeling anxious, possibly panicking, and thinks this may have caused him to have transient shortness of breath. He denies systemic symptoms but had diarrhea for several days after receiving the vaccine. He took Benadryl with resolution of his laryngeal symptoms; the swelling affecting his arm lasted for 3-4 days.
Age: 68.0
Sex: M
Vaccine: PPV
Symptoms: Chills, Headache, Injection site erythema, Injection site swelling, Pain
Clinical narrative: Day of vaccine chills and headache. Next day sore bicep, hurts with any movement, red and swelling at the injection site.
Age: 68.0
Sex: M
Vaccine: PPV
Symptoms: Pain in extremity
Clinical narrative: Day of vaccine chills and headache. Next day sore bicep, hurts with any movement, red and swelling at the injection site.
Age: 1.0
Sex: M
Vaccine: MMR, PNC13
Symptoms: Injection site urticaria, Urticaria
Clinical narrative: Hives at the injection site(Left Thigh) and on the Chest.
Age: 32.0
Sex: F
Vaccine: MMR
Symptoms: Altered state of consciousness, Disturbance in attention, Dizziness, Dysstasia, Lethargy
Clinical narrative: Nausea, vomiting, dizziness, hard time focusing, felt like she was spinning. Later hives, difficulty standing, almost past out, lethargic.
Age: 32.0
Sex: F
Vaccine: MMR
Symptoms: Nausea, Urticaria, Vertigo, Vomiting
Clinical narrative: Nausea, vomiting, dizziness, hard time focusing, felt like she was spinning. Later hives, difficulty standing, almost past out, lethargic.
Age: 80.0
Sex: F
Vaccine: FLU3, PPV
Symptoms: Mobility decreased, Myalgia, Pain in extremity
Clinical narrative: Patient reports have bad muscle pain at deltoid after receiving 2 injections. Patient has requested FLUZONE and PNEUMOVAX on same arm so they were given 1 inch apart and appropriate techniques and policies were followed. Patient was observed for approximately 20 min after injections and reported no pain or adverse effect. Today almost one month later she came to pharmacy and reported arm pain not at joint but at muscle that makes it difficult to lift and is not helped by ice or oral pain medications she is currently taking. She was just seen by a doctor today but it was at a routine neurology appointment.
Age: 68.0
Sex: F
Vaccine: PNC13
Symptoms: Injection site infection
Clinical narrative: Don't know time or date of onset.  Patient was prescribed Cephalexin for infection at injection site on 4/7/17.
Age: 69.0
Sex: F
Vaccine: PPV
Symptoms: Blister, Cellulitis, Erythema, Musculoskeletal disorder, Pain
Clinical narrative: This spontaneous report was received from registered nurse concerning to a 69 year old female patient. The patient's concurrent conditions included hypertension and hyperlipidaemia. The patient was currently a tobacco user. The patient's medical history was not provided. The patient's concomitant medications included atorvastatin, calcium carbonate, vitamin D and ASTELIN. On an unspecified date, the patient experienced allergy to lisinopril (captured in MARRS # 1704USA003065). On 27-MAR-2017, the patient was vaccinated with PNEUMOVAX 23, intramuscular (strength, dose, lot number and expiration date were not reported) for prevention of pneumonia.  On the same date, by the evening, the patient had started to experienced redness and 10 to 10 of pain. The patient experienced a cellulitic reaction from the right shoulder to the elbow, bright red and blistered, fire engine red, warm and tender to touch. The patient went to the doctor's office on 28-MAR-2017 (reported as today) and she was seen by an unspecified physician. The physician ordered a prednisone taper pack, BENADRYL, famotidine (manufacturer unknown) and halobetasol cream. No laboratories or studies were done. At the time of reporting the outcome for the event was unknown. Upon internal review the cellulitic reaction was considered to be a medically significant event. The reporting nurse considered the cellulitic reaction as significant disabling because of the lack of function of the right arm. The causal relationship between the event and the vaccine was not provided. Additional information has been requested. Sender's Comments:  US-009507513-1704USA003065.
Age: 69.0
Sex: F
Vaccine: PPV
Symptoms: Skin warm, Tenderness
Clinical narrative: This spontaneous report was received from registered nurse concerning to a 69 year old female patient. The patient's concurrent conditions included hypertension and hyperlipidaemia. The patient was currently a tobacco user. The patient's medical history was not provided. The patient's concomitant medications included atorvastatin, calcium carbonate, vitamin D and ASTELIN. On an unspecified date, the patient experienced allergy to lisinopril (captured in MARRS # 1704USA003065). On 27-MAR-2017, the patient was vaccinated with PNEUMOVAX 23, intramuscular (strength, dose, lot number and expiration date were not reported) for prevention of pneumonia.  On the same date, by the evening, the patient had started to experienced redness and 10 to 10 of pain. The patient experienced a cellulitic reaction from the right shoulder to the elbow, bright red and blistered, fire engine red, warm and tender to touch. The patient went to the doctor's office on 28-MAR-2017 (reported as today) and she was seen by an unspecified physician. The physician ordered a prednisone taper pack, BENADRYL, famotidine (manufacturer unknown) and halobetasol cream. No laboratories or studies were done. At the time of reporting the outcome for the event was unknown. Upon internal review the cellulitic reaction was considered to be a medically significant event. The reporting nurse considered the cellulitic reaction as significant disabling because of the lack of function of the right arm. The causal relationship between the event and the vaccine was not provided. Additional information has been requested. Sender's Comments:  US-009507513-1704USA003065.
Sex: U
Vaccine: VARCEL
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. No information about the patient's medical history, concurrent conditions, drug reactions or allergies and concomitant therapies was provided. On 18-JAN-2017 at 08:20, the patient was vaccinated with an improperly stored VARIVAX (lot # M031969) for prophylaxis (expiration date, dose and route of administration were not reported). It was reported that the vaccine underwent previous temperature excursions, but the number of previous excursions, time frames and values of incorrect temperature were unknown. A digital data logger was used. No adverse effects were reported. Product quality complaint was not involved. This is one of several reports received from the same reporter. Additional information has been requested. Sender's Comments: US-009507513-1701USA008441: US-009507513-1704USA000389: US-009507513-1704USA000390: US-009507513-1704USA000391: US-009507513-1704USA000392: US-009507513-1704USA000393: US-009507513-1704USA000394: US-009507513-1704USA000395: US-009507513-1704USA000396: US-009507513-1704USA000397: US-009507513-1704USA000398: US-009507513-1704USA000399: US-009507513-1704USA000400: US-009507513-1704USA000401: US-009507513-1704USA000402: US-009507513-1704USA000403: US-009507513-1704USA000404: US-009507513-1704USA000405: US-009507513-1704USA000406: US-009507513-1704USA000407: US-009507513-1704USA000408: US-009507513-1704USA000409: US-009507513-1704USA000410: US-009507513-1704USA000411: US-009507513-1704USA000412: US-009507513-1704USA000413: US-009507513-1704USA000414: US-009507513-1704USA000415: US-009507513-1704USA000416: US-009507513-1704USA000417: US-009507513-1704USA000418: US-009507513-1704USA000419: US-009507513-1704USA000420: US-009507513-1704USA000421: US-009507513-1704USA000422: US-009507513-1704USA000423: US-009507513-1704USA000424: US-009507513-1704USA000425: US-009507513-1704USA000426: US-009507513-1704USA000427: US-009507513-1704USA000428: US-009507513-1704USA000429: US-009507513-1704USA000430: US-009507513-1704USA000431: US-009507513-1704USA000432: US-009507513-1704USA000433: US-009507513-1704USA000434: US-009507513-1704USA000435: US-009507513-1704USA000436: US-009507513-1704USA000437: US-009507513-1704USA000438: US-009507513-1704USA000439: US-009507513-1704USA000440: US-009507513-1704USA000441: US-009507513-1704USA000443: US-009507513-1704USA000444: US-009507513-1704USA000445: US-009507513-1704USA000446: US-009507513-1704USA000447: US-009507513-1704USA000448: US-009507513-1704USA000449: US-009507513-1704USA000450: US-009507513-1704USA000451: US-009507513-1704USA000452: US-009507513-1704USA000453: US-009507513-1704USA000454: US-009507513-1704USA000455: US-009507513-1704USA000456: US-009507513-1704USA000457.
Sex: U
Vaccine: VARCEL
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. No information about the patient's medical history, concurrent conditions, drug reactions or allergies and concomitant therapies was provided. On 10-JAN-2017 at 09:45, the patient was vaccinated with an improperly stored VARIVAX (lot # M031969) for prophylaxis (expiration date, dose and route of administration were not reported). It was reported that the vaccine underwent previous temperature excursions, but the number of previous excursions, time frames and values of incorrect temperature were unknown. A digital data logger was used. No adverse effects were reported. Product quality complaint was not involved. This is one of several reports received from the same reporter. Additional information has been requested.; Sender's Comments: US-009507513-1701USA008441: US-009507513-1704USA000389: US-009507513-1704USA000390: US-009507513-1704USA000391: US-009507513-1704USA000392: US-009507513-1704USA000393: US-009507513-1704USA000394: US-009507513-1704USA000395: US-009507513-1704USA000396: US-009507513-1704USA000397: US-009507513-1704USA000398: US-009507513-1704USA000399: US-009507513-1704USA000400: US-009507513-1704USA000401: US-009507513-1704USA000402: US-009507513-1704USA000403: US-009507513-1704USA000404: US-009507513-1704USA000405: US-009507513-1704USA000406: US-009507513-1704USA000407: US-009507513-1704USA000408: US-009507513-1704USA000409: US-009507513-1704USA000410: US-009507513-1704USA000411: US-009507513-1704USA000412: US-009507513-1704USA000413: US-009507513-1704USA000414: US-009507513-1704USA000415: US-009507513-1704USA000416: US-009507513-1704USA000417: US-009507513-1704USA000418: US-009507513-1704USA000419: US-009507513-1704USA000420: US-009507513-1704USA000421: US-009507513-1704USA000422: US-009507513-1704USA000423: US-009507513-1704USA000424: US-009507513-1704USA000425: US-009507513-1704USA000426: US-009507513-1704USA000427: US-009507513-1704USA000428: US-009507513-1704USA000429: US-009507513-1704USA000430: US-009507513-1704USA000431: US-009507513-1704USA000432: US-009507513-1704USA000433: US-009507513-1704USA000434: US-009507513-1704USA000435: US-009507513-1704USA000436: US-009507513-1704USA000437: US-009507513-1704USA000438: US-009507513-1704USA000439: US-009507513-1704USA000440: US-009507513-1704USA000441: US-009507513-1704USA000442: US-009507513-1704USA000444: US-009507513-1704USA000445: US-009507513-1704USA000446: US-009507513-1704USA000447: US-009507513-1704USA000448: US-009507513-1704USA000449: US-009507513-1704USA000450: US-009507513-1704USA000451: US-009507513-1704USA000452: US-009507513-1704USA000453: US-009507513-1704USA000454: US-009507513-1704USA000455: US-009507513-1704USA000456: US-009507513-1704USA000457.
Sex: U
Vaccine: VARCEL
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. No information about the patient's medical history, concurrent conditions, drug reactions or allergies and concomitant therapies was provided. On 13-JAN-2017 at 15:44, the patient was vaccinated with an improperly stored VARIVAX (lot # M031969) for prophylaxis (expiration date, dose and route of administration were not reported). It was reported that the vaccine underwent previous temperature excursions, but the number of previous excursions, time frames and values of incorrect temperature were unknown. A digital data logger was used. No adverse effects were reported. Product quality complaint was not involved. This is one of several reports received from the same reporter. Additional information has been requested. Sender's Comments: US-009507513-1701USA008441: US-009507513-1704USA000389: US-009507513-1704USA000390: US-009507513-1704USA000391: US-009507513-1704USA000392: US-009507513-1704USA000393: US-009507513-1704USA000394: US-009507513-1704USA000395: US-009507513-1704USA000396: US-009507513-1704USA000397: US-009507513-1704USA000398: US-009507513-1704USA000399: US-009507513-1704USA000400: US-009507513-1704USA000401: US-009507513-1704USA000402: US-009507513-1704USA000403: US-009507513-1704USA000404: US-009507513-1704USA000405: US-009507513-1704USA000406: US-009507513-1704USA000407: US-009507513-1704USA000408: US-009507513-1704USA000409: US-009507513-1704USA000410: US-009507513-1704USA000411: US-009507513-1704USA000412: US-009507513-1704USA000413: US-009507513-1704USA000414: US-009507513-1704USA000415: US-009507513-1704USA000416: US-009507513-1704USA000417: US-009507513-1704USA000418: US-009507513-1704USA000419: US-009507513-1704USA000420: US-009507513-1704USA000421: US-009507513-1704USA000422: US-009507513-1704USA000423: US-009507513-1704USA000424: US-009507513-1704USA000425: US-009507513-1704USA000426: US-009507513-1704USA000427: US-009507513-1704USA000428: US-009507513-1704USA000429: US-009507513-1704USA000430: US-009507513-1704USA000431: US-009507513-1704USA000432: US-009507513-1704USA000433: US-009507513-1704USA000434: US-009507513-1704USA000435: US-009507513-1704USA000436: US-009507513-1704USA000437: US-009507513-1704USA000438: US-009507513-1704USA000439: US-009507513-1704USA000440: US-009507513-1704USA000441: US-009507513-1704USA000442: US-009507513-1704USA000443: US-009507513-1704USA000445: US-009507513-1704USA000446: US-009507513-1704USA000447: US-009507513-1704USA000448: US-009507513-1704USA000449: US-009507513-1704USA000450: US-009507513-1704USA000451: US-009507513-1704USA000452: US-009507513-1704USA000453: US-009507513-1704USA000454: US-009507513-1704USA000455: US-009507513-1704USA000456: US-009507513-1704USA000457.
Age: 12.0
Sex: F
Vaccine: MMR, TDAP, VARCEL
Symptoms: Inappropriate schedule of drug administration, No adverse event
Clinical narrative: This spontaneous report was received from a nurse and refers to a 12 year old female patient. The patient's medical history and concurrent conditions were not reported. On an unknown date, the patient received a previous dose treatment with M-M-R II (dose, route, lot number and expiration date unknown) for prophylaxis. On 20-AUG-2016, the patient was vaccinated with M-M-R II I026553 (invalid), dose 2, intramuscularly in the right deltoid (dose and expiry date were not reported) for prophylaxis (Inappropriate schedule of vaccine administered). Concomitant therapies included TDAP and VARIVAX. This is one of several reports from the same reporter and also has been linked to case# 1702USA009066 via same patient link. Additional information has been requested. Sender's Comments: US-009507513-1701USA005376: US-009507513-1702USA009066.
Age: 12.0
Sex: F
Vaccine: HPV4
Symptoms: Injection site erythema, Injection site swelling
Clinical narrative: Erythema and swelling over Left Deltoid region 11 cm tall 7 cm wide.
Age: 0.17
Sex: F
Vaccine: DTAPHEPBIP, HIBV, PNC13, RV1
Symptoms: Computerised tomogram, Cytogenetic analysis, Electroencephalogram, Epilepsy, Excessive eye blinking
Clinical narrative: SHE BEGAN HAVING TWITCHES WHERE THE RIGHT ARM WOULD STIFFEN AND KEPT MOVING TOWARDS HER FACE. AT THE SAME TIME THE LEFT LEG STIFFEN AND EYES BLINK REPEATEDLY.
Age: 0.17
Sex: F
Vaccine: DTAPHEPBIP, HIBV, PNC13, RV1
Symptoms: Infantile spasms, Lumbar puncture, Metabolic function test, Muscle twitching, Musculoskeletal stiffness
Clinical narrative: SHE BEGAN HAVING TWITCHES WHERE THE RIGHT ARM WOULD STIFFEN AND KEPT MOVING TOWARDS HER FACE. AT THE SAME TIME THE LEFT LEG STIFFEN AND EYES BLINK REPEATEDLY.
Age: 0.17
Sex: F
Vaccine: DTAPHEPBIP, HIBV, PNC13, RV1
Symptoms: Nuclear magnetic resonance imaging
Clinical narrative: SHE BEGAN HAVING TWITCHES WHERE THE RIGHT ARM WOULD STIFFEN AND KEPT MOVING TOWARDS HER FACE. AT THE SAME TIME THE LEFT LEG STIFFEN AND EYES BLINK REPEATEDLY.
Age: 55.0
Sex: F
Vaccine: FLU4
Symptoms: Cholecystectomy, Discomfort, Mobility decreased, Nuclear magnetic resonance imaging, Pain in extremity
Clinical narrative: Pain reported on 1/31/17. October 4th, 2016 When she got the shot there was a lot of pressure and felt a pain down her arm and into her fingers. Nurse stated "not sure why they sent us these long needles". Very petite person. Gallbladder removed and was on pain meds.did not feel for awhile until off meds. Physical Therapy. Started Steroid and pain went away. Went off steroid and pain came back. Was put on a longer regimen of steroid. Next stepMRI and X-Ray. Can't raise arm above arm above head.
Age: 55.0
Sex: F
Vaccine: FLU4
Symptoms: X-ray
Clinical narrative: Pain reported on 1/31/17. October 4th, 2016 When she got the shot there was a lot of pressure and felt a pain down her arm and into her fingers. Nurse stated "not sure why they sent us these long needles". Very petite person. Gallbladder removed and was on pain meds.did not feel for awhile until off meds. Physical Therapy. Started Steroid and pain went away. Went off steroid and pain came back. Was put on a longer regimen of steroid. Next stepMRI and X-Ray. Can't raise arm above arm above head.
Age: 0.5
Sex: M
Vaccine: DTAPHEPBIP, FLU4, HIBV, PNC13
Symptoms: Albumin CSF increased, CSF protein increased, CSF red blood cell count, CSF white blood cell count negative, Clostridium test negative
Clinical narrative: Over a 4hour span on 3/29/17 became acutely hypotonic, with poor suck and lethargy. Admitted to PICU 3/30, Intubated 4/1 for respiratory failure, ruled out botulism and eventually diagnosed with GBS on 4/5 after repeat LP showed 0 RBC, 2 WBC, and >200 protein. Slowly improving with IVIG slated to run a 5 day course (4/5-4/9). Remains hospitalized and intubated (currently day 9 of hospitalization), and anticipate weeks to months more of hospitalization.
Age: 0.5
Sex: M
Vaccine: DTAPHEPBIP, FLU4, HIBV, PNC13
Symptoms: Endotracheal intubation, Guillain-Barre syndrome, Hypotonia, Immunoglobulin therapy, Immunology test normal
Clinical narrative: Over a 4hour span on 3/29/17 became acutely hypotonic, with poor suck and lethargy. Admitted to PICU 3/30, Intubated 4/1 for respiratory failure, ruled out botulism and eventually diagnosed with GBS on 4/5 after repeat LP showed 0 RBC, 2 WBC, and >200 protein. Slowly improving with IVIG slated to run a 5 day course (4/5-4/9). Remains hospitalized and intubated (currently day 9 of hospitalization), and anticipate weeks to months more of hospitalization.
Age: 0.5
Sex: M
Vaccine: DTAPHEPBIP, FLU4, HIBV, PNC13
Symptoms: Intensive care, Laboratory test normal, Lethargy, Poor sucking reflex, Respiratory failure
Clinical narrative: Over a 4hour span on 3/29/17 became acutely hypotonic, with poor suck and lethargy. Admitted to PICU 3/30, Intubated 4/1 for respiratory failure, ruled out botulism and eventually diagnosed with GBS on 4/5 after repeat LP showed 0 RBC, 2 WBC, and >200 protein. Slowly improving with IVIG slated to run a 5 day course (4/5-4/9). Remains hospitalized and intubated (currently day 9 of hospitalization), and anticipate weeks to months more of hospitalization.
Age: 0.5
Sex: M
Vaccine: DTAPHEPBIP, FLU4, HIBV, PNC13
Symptoms: Thyroid function test normal
Clinical narrative: Over a 4hour span on 3/29/17 became acutely hypotonic, with poor suck and lethargy. Admitted to PICU 3/30, Intubated 4/1 for respiratory failure, ruled out botulism and eventually diagnosed with GBS on 4/5 after repeat LP showed 0 RBC, 2 WBC, and >200 protein. Slowly improving with IVIG slated to run a 5 day course (4/5-4/9). Remains hospitalized and intubated (currently day 9 of hospitalization), and anticipate weeks to months more of hospitalization.
Age: 34.0
Sex: F
Vaccine: FLUX, MUR, FLUX, MU, RUB
Symptoms: Chest pain, Dizziness, Fatigue, Respiratory rate increased
Clinical narrative: Chest pain, tiredness and fast breathing, sometimes I feel like I'm going to faint.
Age: 30.0
Sex: M
Vaccine: TDAP
Symptoms: Pain in extremity, Tenderness
Clinical narrative: Sore arm (+) supraclavicular large tender L-N. Same arm 1 day later.
Age: 1.0
Sex: M
Vaccine: HEPA, MMR, PNC13, VARCEL
Symptoms: Febrile convulsion
Clinical narrative: 12 mo ex 32 week with gross motor delay and S/P hypospadias repair. NICU x 25 days at birth. Received 12 mo vaccines and had complex febrile seizure. Admitted 24 hrs for work-up.
Age: 3.0
Sex: M
Vaccine: DTAPIPV
Symptoms: Pyrexia, Swelling
Clinical narrative: Swelling and transient fever.
Age: 12.0
Sex: M
Vaccine: HPVX
Symptoms: Axillary pain, Decreased appetite, Feeling cold, Injection site warmth, Pain
Clinical narrative: Day of - after injection he complained of soreness (to be expected) he did not have an appetite (unusual) Day after - complained of soreness (to be expected) 2nd day after - complaining underarm of injection site now painful, I felt both arms and injection site on left arm feels considerably warmer to touch than right arm/same location.  Says he is cold . . . don't know if related.
Age: 12.0
Sex: M
Vaccine: HPVX
Symptoms: Skin warm
Clinical narrative: Day of - after injection he complained of soreness (to be expected) he did not have an appetite (unusual) Day after - complained of soreness (to be expected) 2nd day after - complaining underarm of injection site now painful, I felt both arms and injection site on left arm feels considerably warmer to touch than right arm/same location.  Says he is cold . . . don't know if related.
Age: 75.0
Sex: F
Vaccine: PPV
Symptoms: Arthralgia, Back pain, Chest pain, Mobility decreased, Musculoskeletal stiffness
Clinical narrative: My shoulder joint began to feel very stiff and sore. The pain migrated to my elbow and wrist as well as my left upper chest and towards my upper back. The pain was very bad. I called the pharmacy where I got the shot and they said to take Aleve or analgesic and apply ice packs.  I could not lie down so I sat up all night on my sofa. Horrible pain. Today is 4/8/17 and I still have pain in my shoulder and elbow. It's hard to bend them.  I reported this to my doctor and the nurse said to apply ice packs, take Aleve. She explained that my body is fighting the vaccine.  I had no problems with the first shot. This was my final shot.  I hope that the pain will dissipate before next week.  I think patients should be advised that this can happen before taking the shots. Thank you.
Age: 76.0
Sex: M
Vaccine: PPV
Symptoms: Axillary pain, Breast pain, Injection site erythema
Clinical narrative: Painful under arm under breast. small amount of redness at injection site. No fever took about 48 hours to resolve.
Age: 1.0
Sex: M
Vaccine: HEPA, MMR, PPV, VARCEL, HEPA, MMR, PNC13, VARCEL
Symptoms: Anaphylactic reaction, Ear swelling, Erythema, Eyelid oedema, Feeling hot
Clinical narrative: Anaphylaxis, started with red rash growing on his face which spread rapidly. His face was hot. Both eyes got puffy but his right eyelid swelled until almost closed, hives on his torso, legs, and arms. His ears and lips began to turn red and grow puffy also. He vomited a few minutes later and began noticeably wheezing. We called the doctor who directed us to administer 3/4 teaspoon of BENADRYL. We gave that to him and took him to ER. Arrived at ER around 2:45pm. At the ER he was observed but he began to recover around 3:00pm. Redness and symptoms persisted for hours but noticeably improved at 3:00pm. They recommended overnight stay but said it was ok to take him home and administer additional BENADRYL every 6 hours for 1 day.
Age: 1.0
Sex: M
Vaccine: HEPA, MMR, PPV, VARCEL, HEPA, MMR, PNC13, VARCEL
Symptoms: Lip discolouration, Lip swelling, Rash, Rash erythematous, Urticaria
Clinical narrative: Anaphylaxis, started with red rash growing on his face which spread rapidly. His face was hot. Both eyes got puffy but his right eyelid swelled until almost closed, hives on his torso, legs, and arms. His ears and lips began to turn red and grow puffy also. He vomited a few minutes later and began noticeably wheezing. We called the doctor who directed us to administer 3/4 teaspoon of BENADRYL. We gave that to him and took him to ER. Arrived at ER around 2:45pm. At the ER he was observed but he began to recover around 3:00pm. Redness and symptoms persisted for hours but noticeably improved at 3:00pm. They recommended overnight stay but said it was ok to take him home and administer additional BENADRYL every 6 hours for 1 day.
Age: 1.0
Sex: M
Vaccine: HEPA, MMR, PPV, VARCEL, HEPA, MMR, PNC13, VARCEL
Symptoms: Vomiting, Wheezing
Clinical narrative: Anaphylaxis, started with red rash growing on his face which spread rapidly. His face was hot. Both eyes got puffy but his right eyelid swelled until almost closed, hives on his torso, legs, and arms. His ears and lips began to turn red and grow puffy also. He vomited a few minutes later and began noticeably wheezing. We called the doctor who directed us to administer 3/4 teaspoon of BENADRYL. We gave that to him and took him to ER. Arrived at ER around 2:45pm. At the ER he was observed but he began to recover around 3:00pm. Redness and symptoms persisted for hours but noticeably improved at 3:00pm. They recommended overnight stay but said it was ok to take him home and administer additional BENADRYL every 6 hours for 1 day.
Age: 1.0
Sex: M
Vaccine: HEPA, MMR, PPV, VARCEL, HEPA, MMR, PNC13, VARCEL
Symptoms: Ear swelling, Eye swelling, Lip swelling, Rash generalised, Vomiting
Clinical narrative: Anaphylaxis, started with red rash growing on his face which spread rapidly. His face was hot. Both eyes got puffy but his right eyelid swelled until almost closed, hives on his torso, legs, and arms. His ears and lips began to turn red and grow puffy also. He vomited a few minutes later and began noticeably wheezing. We called the doctor who directed us to administer 3/4 teaspoon of BENADRYL. We gave that to him and took him to ER. Arrived at ER around 2:45pm. At the ER he was observed but he began to recover around 3:00pm. Redness and symptoms persisted for hours but noticeably improved at 3:00pm. They recommended overnight stay but said it was ok to take him home and administer additional BENADRYL every 6 hours for 1 day.
Age: 69.0
Sex: F
Vaccine: PPV, PPV
Symptoms: Injection site reaction, Muscular weakness
Clinical narrative: Patient has muscle weakness in left arm where vaccine was administered and has been going for physical therapy.
Age: 69.0
Sex: F
Vaccine: PPV, PPV
Symptoms: Anxiety, Immediate post-injection reaction, Injection site nodule, Pain in extremity
Clinical narrative: Patient has muscle weakness in left arm where vaccine was administered and has been going for physical therapy.
Age: 1.0
Sex: M
Vaccine: HEPA, MMR, VARCEL
Symptoms: Chest X-ray, Conjunctivitis, Cough, Dyspnoea, Loss of personal independence in daily activities
Clinical narrative: Exactly 1 week after receiving the MMR vaccine, previously healthy child developed sudden onset of full-body slightly raised, pinpoint red rash, high fevers (103.5 and higher), cough, runny nose, and bilateral conjunctivitis. Severe symptoms, including high fever and rash lasted 5 days and resulted in complication of bilateral otitis media. Also developed tachypnea in the last 2 days of acute illness. Clinical presentation very similar to measles. Resulted in 2 visits to PCP office and several days of lost work and missed daycare.
Age: 1.0
Sex: M
Vaccine: HEPA, MMR, VARCEL
Symptoms: Otitis media, Pyrexia, Rash erythematous, Rash generalised, Rash morbilliform
Clinical narrative: Exactly 1 week after receiving the MMR vaccine, previously healthy child developed sudden onset of full-body slightly raised, pinpoint red rash, high fevers (103.5 and higher), cough, runny nose, and bilateral conjunctivitis. Severe symptoms, including high fever and rash lasted 5 days and resulted in complication of bilateral otitis media. Also developed tachypnea in the last 2 days of acute illness. Clinical presentation very similar to measles. Resulted in 2 visits to PCP office and several days of lost work and missed daycare.
Age: 1.0
Sex: M
Vaccine: HEPA, MMR, VARCEL
Symptoms: Rhinorrhoea, Tachypnoea
Clinical narrative: Exactly 1 week after receiving the MMR vaccine, previously healthy child developed sudden onset of full-body slightly raised, pinpoint red rash, high fevers (103.5 and higher), cough, runny nose, and bilateral conjunctivitis. Severe symptoms, including high fever and rash lasted 5 days and resulted in complication of bilateral otitis media. Also developed tachypnea in the last 2 days of acute illness. Clinical presentation very similar to measles. Resulted in 2 visits to PCP office and several days of lost work and missed daycare.
Age: 30.0
Sex: F
Vaccine: DTAP
Symptoms: Chills, Dysstasia, Injection site erythema, Injection site pain, Injection site warmth
Clinical narrative: Pain, redness (diameter of a baseball), and warmth at the injection site. Chills and achy throughout from the waist down to my legs. Fatigue. Laying down helps a little. Can't stand or sit for more then a short period of time.
Age: 30.0
Sex: F
Vaccine: DTAP
Symptoms: Pain
Clinical narrative: Pain, redness (diameter of a baseball), and warmth at the injection site. Chills and achy throughout from the waist down to my legs. Fatigue. Laying down helps a little. Can't stand or sit for more then a short period of time.
Age: 1.0
Sex: M
Vaccine: HEP, PPV
Symptoms: Cyanosis, Gaze palsy, Hypopnoea, Mydriasis, Posturing
Clinical narrative: My son had a fever then became unresponsive, fixed gaze to the left, dilated pupils, posturing, tremors, shallow breathing and had blueing of the lips and fingers. the whole episode lasted approximitley 4-5 min.
Age: 1.0
Sex: M
Vaccine: HEP, PPV
Symptoms: Pyrexia, Tremor, Unresponsive to stimuli
Clinical narrative: My son had a fever then became unresponsive, fixed gaze to the left, dilated pupils, posturing, tremors, shallow breathing and had blueing of the lips and fingers. the whole episode lasted approximitley 4-5 min.
Age: 4.0
Sex: F
Vaccine: DTAPIPV, MMRV
Symptoms: Injection site erythema, Injection site induration, Injection site rash, Injection site warmth
Clinical narrative: Redness, rash, warm on where the vaccine was placed, skin firmed/hard.
Age: 4.0
Sex: M
Vaccine: HEP
Symptoms: Excessive eye blinking, Tic
Clinical narrative: Approximately 2 weeks after Hepatitis B vaccine Mom noted eye blinking as motor tic - gradually decreased over time. Feels has happened with each Hepatitis B dose.
Age: 31.0
Sex: F
Vaccine: MMR, TDAP
Symptoms: Arthralgia, Asthenia, Fatigue, Feeling cold, Influenza like illness
Clinical narrative: Two days after giving birth to my son via caesarean I was given 2 vaccines and informed that I needed them and it would help protect my baby. I was not informed by the hospital of the possible side effects or risks to my newborn, who I was breast feeding, or myself. I was not released from the hospital until later that day and by then I was already starting to feel like I was coming down with the flu. By the next day my all of my joints were in excruciating pain, I had body aches, and my wrists were so stiff I couldn't pick up my baby. I was sleeping under 3 comforters and have never been more tired in my entire life. What was so odd is I didn't run a fever so I know I didn't have the flu. This went on for 2 weeks. I seriously thought I was going to die. My baby has always had trouble sleeping most nights, has had the flu, an ear ache, and had to undergo breathing treatments all in his first 4 months of life.  No one that has just given birth should ever be given a vaccine of any kind! The body is so weak and stressed from the birth already and when there are viruse vaccinations on top of that is deadly for mother and child. I am a super health and fit person too. These vaccines were pushed on to a scared new mother trying to do what best for her baby and self but this could have killed us both!