chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Sex: U
Vaccine: HPV4
Symptoms: Incorrect storage of drug, No adverse event
Clinical narrative: Information has been received from the registered nurse on 02-JAN-2014. It was reported that GARDASIL vaccines were stored in improper temperatures and were administered to overall number of 132 patients. This report refers to one of the patients involved: a patient of unspecified age and gender, who had administered dose of GARDASIL on 03-SEP-2013 (lot# H021608, Expiration Date: 13-AUG-2015). No adverse event was reported. This is one of the reports from the same source. Additional information is not expected.
Age: 12.0
Sex: F
Vaccine: FLU3
Symptoms: Loss of consciousness
Clinical narrative: Approximately 5 minutes after receiving the vaccine, the patient lost consciousness. She awoke after a few seconds. Her father declined emergency services. She remained in the pharmacy for 15-20 minutes and was monitored. She then left with her father.
Sex: M
Vaccine: VARZOS
Symptoms: Herpes zoster
Clinical narrative: This spontaneous report was received from a pharmacist via company representative refers to a male patient of unknown age. On an unknown date, the patient was vaccinated with ZOSTAVAX (dose, route and frequency was not reported). On an unknown date after receiving ZOSTAVAX, the patient experienced shingles. The outcome of the event shingles was unknown. The reporter did not provide the causality between the event and the suspect drug. Additional information has been requested.
Sex: U
Vaccine: HPV4
Symptoms: Incorrect storage of drug, No adverse event
Clinical narrative: Information has been received from the registered nurse on 02-JAN-2014. It was reported that GARDASIL vaccines were stored in improper temperatures and were administered to overall number of 132 patients. This report refers to one of the patients involved: a patient of unspecified age and gender, who was administered dose of GARDASIL (dose and route not reported) on 16-JUL-2013, lot # reported as 1459AA expiration date: 22-AUG-2014. No adverse event was reported. This is one of the reports from the same source. Lot # 1459AA is an invalid lot # for GARDASIL. Additional information is not expected.
Age: 0.17
Sex: F
Vaccine: DTAP, IPV, RV5
Symptoms: Haematochezia, Mucous stools
Clinical narrative: Gross blood and mucous in stool about 2 hrs after receiving DTaP, IPV and ROTATEQ vaccines.
Age: 25.0
Sex: F
Vaccine: VARCEL
Symptoms: Injection site rash
Clinical narrative: After receiving varicella vaccine pt noticed a rash at the site of injection - Pt returned to clinic 1 week later to report that she still had the rash at the site.
Age: 72.0
Sex: F
Vaccine: VARZOS
Symptoms: Blood test, Burning sensation, Herpes zoster, Hyperaesthesia, Oral herpes
Clinical narrative: This spontaneous report was received from a consumer refers to herself as a 72 year old female patient. The patient was allergic to penicillin. On an unknown date in 2011, the patient was vaccinated with ZOSTAVAX (dose, route and frequency was not reported) to prevent shingles. Concomitant medication included unspecified high blood pressure medication. On 06-JAN-2014, the patient experienced fever blister on her lip, a rash on her upper right leg and groin area and burning sensation in her back and buttocks. It was never blossomed any further, but was improved since then though she still has the rash. The patient reported that it hurts when her clothes rub up against her skin in the affected areas. The patient sought medical attention and called the physician. On 14-JAN-2014, the physician diagnosed the patient with shingles. The patient was treated with Valacyclovir and LYSINE tablets. The outcome of the event shingles was reported as recovering. The reporter did not provided the causality between the event and the suspect drug. Additional information has been requested.
Age: 72.0
Sex: F
Vaccine: VARZOS
Symptoms: Rash
Clinical narrative: This spontaneous report was received from a consumer refers to herself as a 72 year old female patient. The patient was allergic to penicillin. On an unknown date in 2011, the patient was vaccinated with ZOSTAVAX (dose, route and frequency was not reported) to prevent shingles. Concomitant medication included unspecified high blood pressure medication. On 06-JAN-2014, the patient experienced fever blister on her lip, a rash on her upper right leg and groin area and burning sensation in her back and buttocks. It was never blossomed any further, but was improved since then though she still has the rash. The patient reported that it hurts when her clothes rub up against her skin in the affected areas. The patient sought medical attention and called the physician. On 14-JAN-2014, the physician diagnosed the patient with shingles. The patient was treated with Valacyclovir and LYSINE tablets. The outcome of the event shingles was reported as recovering. The reporter did not provided the causality between the event and the suspect drug. Additional information has been requested.
Sex: F
Vaccine: DTAP, HIBV, MMR, PNC
Symptoms: Abnormal behaviour, Asterixis, Autism spectrum disorder, Convulsion, Developmental delay
Clinical narrative: This is a spontaneous report from a non-contactable consumer. A 15-month-old female patient of unspecified ethnicity received single doses of PREVNAR, diphtheria, tetanus and acellular pertussis, haemophilus influenzae b and measles, mumps and rubella, all administered via unspecified routes of administration, on unspecified dates. The patient's medical history and concomitant medications were not reported. On an unspecified date, the mother of the patient reported that her daughter was severely injured by a reaction to the diphtheria, tetanus and acellular pertussis at 15 months of age (when measles, mumps and rubella, haemophilus influenza b and pneumococcal 7-valent conjugate were also given). The mother reported that the patient had a vaccine reaction and just spiraled out of control; onset dates unspecified. On unspecified dates, the patient's fever spiked to 105.7 and she began screaming. The patient also experienced seizure disorder; she stared blankly and developed seizures on an unspecified date. Then she experienced shaking episodes at night and repetitive behaviors, including arm flapping and spinning; onset dates unspecified. She developed a measles-type rash on an unspecified date. Things went from bad to worse; the patient experienced damage and suffering. A neurologist noted on unspecified dates, that the patient had staring spells and an abnormal EEG. Another diagnosed the patient with encephalopathy characterized by speech delay and probable global developmental delay that occurred in the setting of temporal association with immunization as an acute encephalopathy. The patient's mother filed for an encephalopathy table injury in 2003 unaware that the patient would be diagnosed with PDD-NOS, a form of autism spectrum disorder (ASD) on an unspecified date. Relevant lab data on an unspecified date included an EEG and an MRI, which indicated that everything was consistent with encephalopathy, post-vaccination. The clinical outcomes of fever spiked to 105.7, screaming, seizure disorder, staring spells/stared blankly, shaking episodes at night, repetitive behaviors, including arm flapping and spinning, measles-type rash, abnormal EEG, encephalopathy, speech delay, probable global developmental delay and PDD-NOS, a form of autism spectrum disorder (ASD) were unknown. No follow up attempts possible. No further information expected.
Sex: F
Vaccine: DTAP, HIBV, MMR, PNC
Symptoms: Dyskinesia, Electroencephalogram abnormal, Encephalopathy, Injury, Nuclear magnetic resonance imaging brain abnormal
Clinical narrative: This is a spontaneous report from a non-contactable consumer. A 15-month-old female patient of unspecified ethnicity received single doses of PREVNAR, diphtheria, tetanus and acellular pertussis, haemophilus influenzae b and measles, mumps and rubella, all administered via unspecified routes of administration, on unspecified dates. The patient's medical history and concomitant medications were not reported. On an unspecified date, the mother of the patient reported that her daughter was severely injured by a reaction to the diphtheria, tetanus and acellular pertussis at 15 months of age (when measles, mumps and rubella, haemophilus influenza b and pneumococcal 7-valent conjugate were also given). The mother reported that the patient had a vaccine reaction and just spiraled out of control; onset dates unspecified. On unspecified dates, the patient's fever spiked to 105.7 and she began screaming. The patient also experienced seizure disorder; she stared blankly and developed seizures on an unspecified date. Then she experienced shaking episodes at night and repetitive behaviors, including arm flapping and spinning; onset dates unspecified. She developed a measles-type rash on an unspecified date. Things went from bad to worse; the patient experienced damage and suffering. A neurologist noted on unspecified dates, that the patient had staring spells and an abnormal EEG. Another diagnosed the patient with encephalopathy characterized by speech delay and probable global developmental delay that occurred in the setting of temporal association with immunization as an acute encephalopathy. The patient's mother filed for an encephalopathy table injury in 2003 unaware that the patient would be diagnosed with PDD-NOS, a form of autism spectrum disorder (ASD) on an unspecified date. Relevant lab data on an unspecified date included an EEG and an MRI, which indicated that everything was consistent with encephalopathy, post-vaccination. The clinical outcomes of fever spiked to 105.7, screaming, seizure disorder, staring spells/stared blankly, shaking episodes at night, repetitive behaviors, including arm flapping and spinning, measles-type rash, abnormal EEG, encephalopathy, speech delay, probable global developmental delay and PDD-NOS, a form of autism spectrum disorder (ASD) were unknown. No follow up attempts possible. No further information expected.
Sex: F
Vaccine: DTAP, HIBV, MMR, PNC
Symptoms: Pyrexia, Rash morbilliform, Screaming, Speech disorder developmental, Staring
Clinical narrative: This is a spontaneous report from a non-contactable consumer. A 15-month-old female patient of unspecified ethnicity received single doses of PREVNAR, diphtheria, tetanus and acellular pertussis, haemophilus influenzae b and measles, mumps and rubella, all administered via unspecified routes of administration, on unspecified dates. The patient's medical history and concomitant medications were not reported. On an unspecified date, the mother of the patient reported that her daughter was severely injured by a reaction to the diphtheria, tetanus and acellular pertussis at 15 months of age (when measles, mumps and rubella, haemophilus influenza b and pneumococcal 7-valent conjugate were also given). The mother reported that the patient had a vaccine reaction and just spiraled out of control; onset dates unspecified. On unspecified dates, the patient's fever spiked to 105.7 and she began screaming. The patient also experienced seizure disorder; she stared blankly and developed seizures on an unspecified date. Then she experienced shaking episodes at night and repetitive behaviors, including arm flapping and spinning; onset dates unspecified. She developed a measles-type rash on an unspecified date. Things went from bad to worse; the patient experienced damage and suffering. A neurologist noted on unspecified dates, that the patient had staring spells and an abnormal EEG. Another diagnosed the patient with encephalopathy characterized by speech delay and probable global developmental delay that occurred in the setting of temporal association with immunization as an acute encephalopathy. The patient's mother filed for an encephalopathy table injury in 2003 unaware that the patient would be diagnosed with PDD-NOS, a form of autism spectrum disorder (ASD) on an unspecified date. Relevant lab data on an unspecified date included an EEG and an MRI, which indicated that everything was consistent with encephalopathy, post-vaccination. The clinical outcomes of fever spiked to 105.7, screaming, seizure disorder, staring spells/stared blankly, shaking episodes at night, repetitive behaviors, including arm flapping and spinning, measles-type rash, abnormal EEG, encephalopathy, speech delay, probable global developmental delay and PDD-NOS, a form of autism spectrum disorder (ASD) were unknown. No follow up attempts possible. No further information expected.
Sex: F
Vaccine: DTAP, HIBV, MMR, PNC
Symptoms: Tremor, Vaccination complication
Clinical narrative: This is a spontaneous report from a non-contactable consumer. A 15-month-old female patient of unspecified ethnicity received single doses of PREVNAR, diphtheria, tetanus and acellular pertussis, haemophilus influenzae b and measles, mumps and rubella, all administered via unspecified routes of administration, on unspecified dates. The patient's medical history and concomitant medications were not reported. On an unspecified date, the mother of the patient reported that her daughter was severely injured by a reaction to the diphtheria, tetanus and acellular pertussis at 15 months of age (when measles, mumps and rubella, haemophilus influenza b and pneumococcal 7-valent conjugate were also given). The mother reported that the patient had a vaccine reaction and just spiraled out of control; onset dates unspecified. On unspecified dates, the patient's fever spiked to 105.7 and she began screaming. The patient also experienced seizure disorder; she stared blankly and developed seizures on an unspecified date. Then she experienced shaking episodes at night and repetitive behaviors, including arm flapping and spinning; onset dates unspecified. She developed a measles-type rash on an unspecified date. Things went from bad to worse; the patient experienced damage and suffering. A neurologist noted on unspecified dates, that the patient had staring spells and an abnormal EEG. Another diagnosed the patient with encephalopathy characterized by speech delay and probable global developmental delay that occurred in the setting of temporal association with immunization as an acute encephalopathy. The patient's mother filed for an encephalopathy table injury in 2003 unaware that the patient would be diagnosed with PDD-NOS, a form of autism spectrum disorder (ASD) on an unspecified date. Relevant lab data on an unspecified date included an EEG and an MRI, which indicated that everything was consistent with encephalopathy, post-vaccination. The clinical outcomes of fever spiked to 105.7, screaming, seizure disorder, staring spells/stared blankly, shaking episodes at night, repetitive behaviors, including arm flapping and spinning, measles-type rash, abnormal EEG, encephalopathy, speech delay, probable global developmental delay and PDD-NOS, a form of autism spectrum disorder (ASD) were unknown. No follow up attempts possible. No further information expected.
Age: 0.21
Sex: M
Vaccine: DTAPHEPBIP, HIBV, PNC13, RV1
Symptoms: Abdominal X-ray, Haematochezia, Ultrasound abdomen, Vomiting
Clinical narrative: Vaccines given - 1/7/14. ED visit on 1/12/14 - for vomiting and hematochezia. Admitted to hospital for evaluation and possible surgery. Pt presently monitored at hospital.
Age: 54.0
Sex: F
Vaccine: FLU3, FLU3
Symptoms: Chapped lips, Lip blister, Lip exfoliation, Lip swelling, Oral pruritus
Clinical narrative: Lips - started itching and feeling chapped 3:00 pm day of injection - applied Chapstick. Nex today 1.15 and 1.16 lips swollen as if injected w/ BOTOX. Slight blistering inside upper middle lip. Still slight swelling, peeling, itching on 1-21-14.
Age: 54.0
Sex: F
Vaccine: FLU3, FLU3
Symptoms: Lip swelling
Clinical narrative: Lips - started itching and feeling chapped 3:00 pm day of injection - applied Chapstick. Nex today 1.15 and 1.16 lips swollen as if injected w/ BOTOX. Slight blistering inside upper middle lip. Still slight swelling, peeling, itching on 1-21-14.
Age: 21.0
Sex: M
Vaccine: FLU3, FLU3
Symptoms: Consciousness fluctuating, Dyspnoea, Erythema, Flushing, Gaze palsy
Clinical narrative: I administered FLUVIRIN to patient, immediately upon withdrawing the needle the following events took place: eyes rolled back, face - limped to left side, face became severely red - flushed, patient seemed in and out of consciousness, we layed on floor, patient became short of breath immediately gave EPIPEN 0.3mg in left upper thigh muscle.
Age: 21.0
Sex: M
Vaccine: FLU3, FLU3
Symptoms: Hypotonia, Immediate post-injection reaction
Clinical narrative: I administered FLUVIRIN to patient, immediately upon withdrawing the needle the following events took place: eyes rolled back, face - limped to left side, face became severely red - flushed, patient seemed in and out of consciousness, we layed on floor, patient became short of breath immediately gave EPIPEN 0.3mg in left upper thigh muscle.
Age: 21.0
Sex: M
Vaccine: FLU3, FLU3
Symptoms: Consciousness fluctuating, Dyspnoea, Erythema, Eye movement disorder, Flushing
Clinical narrative: I administered FLUVIRIN to patient, immediately upon withdrawing the needle the following events took place: eyes rolled back, face - limped to left side, face became severely red - flushed, patient seemed in and out of consciousness, we layed on floor, patient became short of breath immediately gave EPIPEN 0.3mg in left upper thigh muscle.
Age: 21.0
Sex: M
Vaccine: FLU3, FLU3
Symptoms: Immediate post-injection reaction, VIIth nerve paralysis
Clinical narrative: I administered FLUVIRIN to patient, immediately upon withdrawing the needle the following events took place: eyes rolled back, face - limped to left side, face became severely red - flushed, patient seemed in and out of consciousness, we layed on floor, patient became short of breath immediately gave EPIPEN 0.3mg in left upper thigh muscle.
Age: 67.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site erythema, Injection site pain, Injection site pruritus, Injection site swelling
Clinical narrative: Site of shot. Swollen, red, tender to touch, itchy.
Age: 55.0
Sex: F
Vaccine: FLU3
Symptoms: Fatigue, Hypoaesthesia, Loss of consciousness
Clinical narrative: Received vaccine and 48 hrs later, lost feeling in hands then body from a blackout. Had felt exhausted after shot for months. Exhaustion for that year.
Age: 57.0
Sex: F
Vaccine: FLUR3
Symptoms: Erythema, Inflammation, Pruritus, Swelling face
Clinical narrative: Swollen, red, itchy, inflamed face (starting 1 1/2 days after vaccine injected).
Age: 24.0
Sex: F
Vaccine: TDAP
Symptoms: Chest discomfort, Dyspnoea, Fatigue, Headache
Clinical narrative: Pt given Tdap to (R) deltoid 1/9/14. Pt called on Mon. 1/13/14 c/o chest heaviness, fatigue at feeling short of breath over the weekend. She did not seek medical advice over the weekend and denies s/sx today. Resolved. Also c/o headache behind both eyes - resolved.
Sex: U
Vaccine: VARZOS
Symptoms: Incorrect storage of drug, No adverse event
Clinical narrative: Information has been received from a registered nurse regarding an unknown age and gender patient who on 17-OCT-2013 was administered an out of temperature range dose of ZOSTAVAX, batch # 0468AE (dose and route were not reported). No adverse experience had been reported. This is one of 182 reports from the same source. Additional information has been requested.
Age: 37.0
Sex: F
Vaccine: VARCEL
Symptoms: Blister, Injection site induration, Injection site pain, Injection site warmth, Skin infection
Clinical narrative: Three weeks after varicella vaccine she noticed that injection site was painful to touch, was hot and hard. She also had a couple blisters on her neck and scalp. She was diagnosed with a mild case of chickenpox and antibiotics were prescribed for the arm infection.
Age: 37.0
Sex: F
Vaccine: VARCEL
Symptoms: Varicella post vaccine
Clinical narrative: Three weeks after varicella vaccine she noticed that injection site was painful to touch, was hot and hard. She also had a couple blisters on her neck and scalp. She was diagnosed with a mild case of chickenpox and antibiotics were prescribed for the arm infection.
Age: 39.0
Sex: M
Vaccine: FLU3, PPV
Symptoms: Injection site erythema, Injection site pain, Injection site swelling
Clinical narrative: This spontaneous report as received from a physician via a company representative refers to a male patient of unknown age with diabetes. On an unknown date the patient was vaccinated with a dose of PNEUMOVAX 23, (lot#, expiration date, dose and route not reported), "Because of Diabetic Status". The patient developed pain, swelling, and erythema at the injection site after receiving PNEUMOVAX 23. The patient was seen in an unspecified emergency room on an unspecified date and received an unspecified antibiotic. On an unknown date, the patient was recovered from the adverse events. Additional information has been requested.
Age: 31.0
Sex: F
Vaccine: VARCEL
Symptoms: Injection site discharge, Pyrexia, Vaccination site inflammation, Vaccination site pain, Vaccination site swelling
Clinical narrative: Pt stated 2 days after vaccine site became inflammed, painful, swollen, and purulent. Pt reported having a fever. Pt stated was better after a few days.
Age: 47.0
Sex: F
Vaccine: FLUX(H1N1)
Symptoms: Erythema, Oral discomfort
Clinical narrative: Burning of the corner of the mouth, extending to upper lip. No rash, very mild redness. This occurred every few days, then every week, then every few weeks, then every few months until by the end of the year the symptoms stopped completely.
Age: 41.0
Sex: F
Vaccine: FLU3
Symptoms: Cough, Dysphagia, Hypoaesthesia oral, Injection site erythema, Injection site pruritus
Clinical narrative: Throat and lip numbness.  Feeling of lump in throat and coughing.  C/o difficulty swallowing.  C/o arm swelling, redness and itching at site of injection.  Took PO Benadryl with some relief.  Seen in ED at 3 PM and treated with IV steroids.
Age: 41.0
Sex: F
Vaccine: FLU3
Symptoms: Injection site swelling, Pharyngeal hypoaesthesia, Sensation of foreign body
Clinical narrative: Throat and lip numbness.  Feeling of lump in throat and coughing.  C/o difficulty swallowing.  C/o arm swelling, redness and itching at site of injection.  Took PO Benadryl with some relief.  Seen in ED at 3 PM and treated with IV steroids.
Age: 77.0
Sex: F
Vaccine: PPV
Symptoms: Body temperature increased, Cough, Dizziness, Headache, Malaise
Clinical narrative: Patient felt fine when she was at the doctor's office. After receiving the shot, patient went home and started to feel dizzy, nauseous and her shoulder was sore. Patient called in the next day and talked to nurses. Was in bed for two days with 102 temperature and not feeling well at all. Horrible cough to the point where she would wretch and her head hurt.  Still has on Jan 20th but not as bad.
Age: 77.0
Sex: F
Vaccine: PPV
Symptoms: Musculoskeletal pain, Nausea, Retching
Clinical narrative: Patient felt fine when she was at the doctor's office. After receiving the shot, patient went home and started to feel dizzy, nauseous and her shoulder was sore. Patient called in the next day and talked to nurses. Was in bed for two days with 102 temperature and not feeling well at all. Horrible cough to the point where she would wretch and her head hurt.  Still has on Jan 20th but not as bad.
Age: 28.0
Sex: M
Vaccine: FLUC3, FLUC3
Symptoms: Adverse reaction, Disorientation, Dizziness, Loss of consciousness, Pallor
Clinical narrative: Patient started to feel faint. Started to turn pale white.  Patient stated "I think I am having a reaction." Patient then blacked out and was unaware of his surroundings for a just a minute before coming to.
Age: 28.0
Sex: M
Vaccine: FLUC3, FLUC3
Symptoms: Disorientation, Dizziness, Loss of consciousness, Pallor
Clinical narrative: Patient started to feel faint. Started to turn pale white.  Patient stated "I think I am having a reaction." Patient then blacked out and was unaware of his surroundings for a just a minute before coming to.
Age: 32.0
Sex: M
Vaccine: FLUC3
Symptoms: HIV test, Hepatitis B virus test, Hepatitis C virus test, Injury associated with device
Clinical narrative: Accidental needle stick to administrator.
Age: 67.0
Sex: M
Vaccine: FLUC3
Symptoms: Injection site inflammation, Injection site pustule
Clinical narrative: The injection site was inflamed with pus in the middle.
Age: 0.6
Sex: M
Vaccine: HIBV
Symptoms: Electroencephalogram normal, Posture abnormal
Clinical narrative: Our daughter began dropping her head to her chest randomly the evening after her hib shot. She would be playing and just drop her head several times (almost like she lost muscle tone briefly) in the space of a couple of minutes. This happened multiple times a day, every day for weeks. It still happens occasionally, though not nearly as frequently.  We are down to about 1 or 2 times a week.  She was sent to a neurologist who said it could possibly be drop seizures, but her EEG came back normal. She was referred to a chiropractor who has helped some.
Age: 55.0
Sex: F
Vaccine: FLU3
Symptoms: Fatigue, Furuncle, Inflammation, Influenza like illness, Injection site pain
Clinical narrative: Soreness in left arm (10/19/13 - present) Boil/pain at injection site Fatigue and flu-like achiness arms/legs Generalized overall feeling of inflammation.
Age: 55.0
Sex: F
Vaccine: FLU3
Symptoms: Injection site reaction, Pain in extremity
Clinical narrative: Soreness in left arm (10/19/13 - present) Boil/pain at injection site Fatigue and flu-like achiness arms/legs Generalized overall feeling of inflammation.
Age: 9.0
Sex: F
Vaccine: FLUN4, HPV4
Symptoms: Computerised tomogram, Convulsion, Electroencephalogram, Fall, Feeling abnormal
Clinical narrative: 11/29/2013 client expressed a "funny", "sinking into the floor" feeling in her leg. 11/30/13 still complained of this. Then per the client's mother she fell to the floor and had a seizure. Was taken by ambulance to the ER. This was client's right leg.
Age: 9.0
Sex: F
Vaccine: FLUN4, HPV4
Symptoms: Sensory disturbance
Clinical narrative: 11/29/2013 client expressed a "funny", "sinking into the floor" feeling in her leg. 11/30/13 still complained of this. Then per the client's mother she fell to the floor and had a seizure. Was taken by ambulance to the ER. This was client's right leg.
Age: 87.0
Sex: F
Vaccine: VARZOS
Symptoms: Cardiac function test normal, Chest pain, Herpes zoster, Rash
Clinical narrative: 1/7 Chest pain - admitted to hospital. 1/8 Discharged from hospital. 1/9 Rash in area of chest pain. 1/15 Diagnosed with shingles by PCP.
Age: 11.0
Sex: F
Vaccine: TDAP
Symptoms: Arthralgia, Blister, Laboratory test, Urticaria, Vomiting
Clinical narrative: Per parent - "water blisters" on (L) arm about 2 hrs. after receiving the vaccine. Tdap was given in (L) arm. Patient then broke out in hives and blisters from her shoulders down to her feet. Patient was vomiting "violently" for about a half a hour. Patient was complaining of joint pain, especially in her legs. Mom gave patient 2 teaspoons of Children's BENADRYL and took pt to the ER.
Age: 70.0
Sex: F
Vaccine: VARZOS
Symptoms: Computerised tomogram head normal, Neurological examination normal, VIIth nerve paralysis
Clinical narrative: Diagnosed with Bell's palsy 12-18-13.
Age: 43.0
Sex: F
Vaccine: FLU3
Symptoms: Injection site erythema, Injection site pruritus, Injection site swelling, Injection site warmth
Clinical narrative: Redness, swelling, itching, warmth on arm at site of injection beginning within hours after injection. Applied diphenhydramine cream and symptoms have decreased.
Age: 65.0
Sex: M
Vaccine: VARZOS
Symptoms: Cellulitis, Erythema, Headache, Injection site erythema, Injection site pruritus
Clinical narrative: Deep red raised circle - 2.5 inches in diameter around site of injection. Redness has spread down the arm. Site is itchy. Redness and irritation started morning of 1/10/14 continued to spread thru 10:00 am 1/11/14. Pt complained of a HA on the 9th told pt to go to the ER and get checked out.
Age: 65.0
Sex: M
Vaccine: VARZOS
Symptoms: Injection site swelling, Skin irritation
Clinical narrative: Deep red raised circle - 2.5 inches in diameter around site of injection. Redness has spread down the arm. Site is itchy. Redness and irritation started morning of 1/10/14 continued to spread thru 10:00 am 1/11/14. Pt complained of a HA on the 9th told pt to go to the ER and get checked out.
Age: 51.0
Sex: F
Vaccine: FLU4
Symptoms: Injection site erythema, Injection site induration, Injection site mass, Injection site pain, Injection site warmth
Clinical narrative: Initial redness and hard lump at injection site (quarter-sized) noted on 1/4/14. Redness, pain, heat radiating outward from injection site (fist sized) on 1/5/14. Diagnosed as staph infection 1/6/14 by general practitioner, area expanded to majority of upper arm. Initiated antibiotic therapy to treat.
Age: 51.0
Sex: F
Vaccine: FLU4
Symptoms: Staphylococcal infection
Clinical narrative: Initial redness and hard lump at injection site (quarter-sized) noted on 1/4/14. Redness, pain, heat radiating outward from injection site (fist sized) on 1/5/14. Diagnosed as staph infection 1/6/14 by general practitioner, area expanded to majority of upper arm. Initiated antibiotic therapy to treat.
Age: 0.6
Sex: F
Vaccine: DTAP, HIBV, IPV, PNC13
Symptoms: Pyrexia
Clinical narrative: Vaccines administered 1-7-14, mother reported fever 103 degrees evening of 1-8-14 no other symptoms, no local reactions at injection sites. Mother took infant to local ER. No significant findings. Administered TYLENOL and ibuprofen fever diminished.
Sex: U
Vaccine: HPV4
Symptoms: Incorrect storage of drug, No adverse event
Clinical narrative: Information has been received from a registered nurse. It was reported that GARDASIL vaccines was stored in improper temperatures and were administered to overall number of 132 patients. This report refers to one of the patients involved: a patient of unspecified age and gender, who had been administered a dose of GARDASIL on 03-JAN-2013 (lot number 670048/0963AA, expiration date 09-NOV-2013) (dose and route not reported). No adverse event was reported. This is one of the reports from the same source. Additional information is not expected.
Age: 5.0
Sex: F
Vaccine: RAB
Symptoms: Inappropriate schedule of drug administration, No adverse event
Clinical narrative: Patient received 2 doses of 1cc IMOVAX Rabies vaccine simultaneously (via 2 nurses). No adverse reaction as of 5 days later (1/13/14).
Sex: U
Vaccine: HPV4
Symptoms: Incorrect storage of drug, No adverse event
Clinical narrative: Information has been received from a registered nurse. It was reported that GARDASIL vaccines were stored in improper temperatures and were administered to overall number of 132 patients. This report refers to one of the patients involved: a patient of unspecified age and gender, who had been administered dose of GARDASIL on 17-JAN-2013 (lot number H011350, expiration date 21-FEB-2015) (dose and route not reported). No adverse event was reported. This is one of the reports from the same source. Additional information is not expected.
Age: 51.0
Sex: U
Vaccine: TD
Symptoms: Feeling abnormal, Local swelling, Pain in extremity
Clinical narrative: My whole arm hurts so bad can't stand it. Clear to bone. Arm swollen pure misery.
Age: 62.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site erythema, Injection site pain, Injection site swelling, Injection site vesicles
Clinical narrative: Information has been received from a pharmacist concerning a 62 year old female patient with type 2 diabetes mellitus, hypertension and no drug reactions or allergies. The patient might has shingles in the past. On 11-JAN-2014 the patient was vaccinated with a 0.65 ml dose of ZOSTAVAX lot # J011338, exp date 19-DEC-2014, subcutaneous for prophylaxis (dose number not provided). Concomitant therapies included INVOKANA, metformin and EDARBYCLOR. In January 2014 a patient developed a red, raised, round, slightly swollen area and fluid filled blister "the size of a quarter" on her arm at the injection site after receiving ZOSTAVAX. The pharmacist stated that patient reporter to her, that this area was tender to touch. There was no treatment given for the events. There were no labs performed. The outcome of patient developed a red, raised, round, slightly swollen area and fluid filled blister "the size of a quarter" on her arm at the injection site after receiving ZOSTAVAX was reported as not recovered/not resolved. It was reported that patient came back into the pharmacy. Additional information has been requested.
Age: 3.0
Sex: F
Vaccine: DTAPHEPBIP
Symptoms: No adverse event, Wrong drug administered
Clinical narrative: Pt was given the PEDIARIX that was to be given to her sister instead of a flu shot. No reaction noted at this time.
Sex: U
Vaccine: HPV4
Symptoms: Incorrect storage of drug, No adverse event
Clinical narrative: Information has been received from a registered nurse. It was reported that GARDASIL vaccines were stored in improper temperatures and were administered to overall number of 132 patients. This report refers to one of the patients involved: a patient of unspecified age and gender, who had been administered a dose of GARDASIL on 17-JAN-2013 (lot number H011350, expiration date 21-FEB-2015) (dose and route not reported). No adverse event was reported. This is one of the reports from the same source. Additional information is not expected.
Age: 31.0
Sex: F
Vaccine: FLU3
Symptoms: Paraesthesia oral, Swollen tongue
Clinical narrative: Client received flu vaccine at 930 am - At 2:30 pm client said tongue felt funny and tongue felt swollen. Speech was normal breathing normal. Referred to ER. 10/21/13 talked to client - went to MD 10/17 no more problems said her MD told her to see an allergist before receiving flu vaccine next year.
Sex: U
Vaccine: HPV4
Symptoms: Incorrect storage of drug, No adverse event
Clinical narrative: Information has been received from the registered nurse. It was reported that GARDASIL vaccines were stored in improper temperatures and were administered to overall number of 132 patients. This report refers to one of the patients involved: a patient of unspecified age and gender, who had been administered dose of GARDASIL on 14-JAN-2013 (dose, route and lot number not reported). No adverse event was reported. This is one of the reports from the same source. Additional information is not expected.
Age: 51.0
Sex: F
Vaccine: FLU3
Symptoms: Urticaria
Clinical narrative: After patient left store, experienced hives that covered entire body. Patient took a BENADRYL which did not aleve symptoms. Seeked medical attention, Dr. who prescribed oral and topical steroids. Next day, saw allergist who prescribed SINGULAIR and ZYRTEC. Symptoms lasted 5-7 days.
Age: 29.0
Sex: F
Vaccine: FLU4
Symptoms: Laboratory test normal, Unevaluable event
Clinical narrative: All normal.
Age: 18.0
Sex: F
Vaccine: MNQ
Symptoms: Cough, Dysphonia, Nausea
Clinical narrative: Patient c/o hoarseness, cough and nausea. Patient prescribed ZOFRAN 4 mg every 8 hrs PRN for the nausea. Vital signs within normal limits.
Age: 12.0
Sex: M
Vaccine: FLU4, TDAP
Symptoms: Joint swelling
Clinical narrative: Left knee swelling ? reactive effusion.
Age: 0.41
Sex: M
Vaccine: DTAP, HIBV, IPV, PNC13
Symptoms: Blood test, Conjunctivitis infective, Infection, Laboratory test, Pyrexia
Clinical narrative: High fever over 103 degrees for an infant for 1 week/7 days. Infection in urine and in blood. Pink eye/conjunctivitis. Hospitalization fluids administered and antibiotics administered. Note: Antibiotics started to be administered prior to blood tests and pink eye tests, etc.
Age: 0.41
Sex: M
Vaccine: DTAP, HIBV, IPV, PNC13
Symptoms: Urinary tract infection
Clinical narrative: High fever over 103 degrees for an infant for 1 week/7 days. Infection in urine and in blood. Pink eye/conjunctivitis. Hospitalization fluids administered and antibiotics administered. Note: Antibiotics started to be administered prior to blood tests and pink eye tests, etc.
Age: 78.0
Sex: F
Vaccine: FLU3, VARZOS, FLU3, VARZOS
Symptoms: Dizziness, Fall, Pain, Vision blurred
Clinical narrative: I had been to a store, ATM and pharmacy. Got a flu shot in left shoulder and shingles in the right shoulder. Was in my house with my few purchases, leaned over to pick up an item and things got blurry and dizzy and I fell to the floor. Went to hospital about 12 hrs. later due to extreme pain - I assume from the fall.
Sex: U
Vaccine: HPV4
Symptoms: Incorrect storage of drug, No adverse event
Clinical narrative: Information has been received from the registered nurse. It was reported that GARDASIL vaccines were stored in improper temperatures and were administered to overall number of 132 patients. This report refers to one of the patients involved: a patient of unspecified age and gender, who had been administered dose of GARDASIL on 17-JAN-2013 (lot number 672834/0131AE, expiration date 26-OCT-2014) (dose and route not reported). No adverse event was reported. This is one of the reports from the same source. Additional information is not expected.
Age: 4.0
Sex: F
Vaccine: DTAP, IPV, MMRV
Symptoms: Rash erythematous, Vaccination site reaction
Clinical narrative: Local redness/rash on areas of vaccine injections. Treated on 1/4/14 with prednisone and antihistamines at urgent care.
Age: 26.0
Sex: M
Vaccine: SMALL, SMALL
Symptoms: Injection site reaction, Laceration
Clinical narrative: 3 wks after vaccination, when changing bandage caused a break in pts skin (L) upper arm. Treated like smallpox, covered with separate bandage. Likely caused secondary smallpox site per Doc.
Age: 26.0
Sex: M
Vaccine: SMALL, SMALL
Symptoms: Injection site reaction, Skin disorder
Clinical narrative: 3 wks after vaccination, when changing bandage caused a break in pts skin (L) upper arm. Treated like smallpox, covered with separate bandage. Likely caused secondary smallpox site per Doc.
Age: 4.0
Sex: M
Vaccine: HEPA, TYP
Symptoms: Chills, Lethargy, Pyrexia, Rash, Rash macular
Clinical narrative: 12-26-13: Mother of client called HD to report that patient was lethargic with a red blotchy face and was shivering uncontrollably. She was instructed to go to the ER. F/U call on 12-30-13 when mother stated patient had the above mentioned symptoms and fever of 101 degrees F through the night but all symptoms cleared by the next morning on 12-27-13. She did not go to the ER.
Age: 55.0
Sex: F
Vaccine: FLU3, VARZOS
Symptoms: Headache, Injection site erythema, Injection site pruritus, Injection site swelling, Lymphadenopathy
Clinical narrative: Itching, swelling, redness at site, headache, swollen lymph nodes in axilla.
Age: 45.0
Sex: F
Vaccine: FLU3
Symptoms: Injection site nodule, Injection site warmth, Pain in extremity
Clinical narrative: Pt c/o knot and warm to touch feeling on injection site Lt deltoid also c/o (L) arm pain radiation upper and lower arm.
Age: 68.0
Sex: F
Vaccine: VARZOS
Symptoms: Cellulitis
Clinical narrative: Patient developed cellulitis several days after receiving the Zostavax.
Age: 2.0
Sex: F
Vaccine: FLU3, HEPA
Symptoms: Drug administered to patient of inappropriate age
Clinical narrative: None.
Age: 0.56
Sex: M
Vaccine: DTAP, HEP, PNC13, RV5
Symptoms: Injection site urticaria, Urticaria
Clinical narrative: Hives on (R) cheek (L) chest (R) shoulder (L) buttocks and (R) thigh at injection site.
Age: 60.0
Sex: M
Vaccine: VARZOS
Symptoms: Injection site erythema, Injection site induration, Injection site swelling, Injection site warmth
Clinical narrative: Injection site reaction - consisting of moderate to severe redness, swelling, firmness and heat beginning day after vaccine, maximizing 2 days later, and subsiding over 2-3 more days.
Sex: U
Vaccine: FLU3, PPV
Symptoms: Injection site erythema, Injection site pain, Injection site swelling
Clinical narrative: Swelling, redness and pain at injection site, (L) arm.
Age: 66.0
Sex: M
Vaccine: FLU3
Symptoms: Injection site rash, Rash
Clinical narrative: Rash to chest appearing approximately 4 days after injection. Spread to upper arms and low back.
Age: 23.0
Sex: M
Vaccine: FLUC3, FLUC3
Symptoms: Immediate post-injection reaction, Syncope
Clinical narrative: Patient fainted as flu shot was being administered.
Age: 0.52
Sex: F
Vaccine: DTAPHEPBIP, FLU3, HIBV, PNC13
Symptoms: Conjunctivitis, Periorbital oedema
Clinical narrative: Periorbital erythema, yellow conjunctival discharge, normal sclera - reaction after both doses of flu.
Age: 14.0
Sex: M
Vaccine: FLU3, PPV
Symptoms: Rash
Clinical narrative: Rash over weekend of 01-17-14. Rash kept growing per mom.
Age: 57.0
Sex: F
Vaccine: FLU3, FLU3
Symptoms: Asthenia, Feeling abnormal, Gait disturbance, Influenza virus test negative, Muscular weakness
Clinical narrative: Patient stated she "felt weird" when she woke up at 0500. At 2:00 PM she became weak, it was hard for her to walk. Stated bilateral arms and legs were weak. Reported to her PCP. Flu test (-), sent home. 1/14/14 Back to her PCP. Now only feels weak on (L) side, sent to hosp. for stroke work up.
Age: 57.0
Sex: F
Vaccine: FLU3, FLU3
Symptoms: Neuropathy peripheral
Clinical narrative: Patient stated she "felt weird" when she woke up at 0500. At 2:00 PM she became weak, it was hard for her to walk. Stated bilateral arms and legs were weak. Reported to her PCP. Flu test (-), sent home. 1/14/14 Back to her PCP. Now only feels weak on (L) side, sent to hosp. for stroke work up.
Age: 57.0
Sex: F
Vaccine: FLU3, FLU3
Symptoms: Asthenia, Feeling abnormal, Gait disturbance, Hemiparesis, Influenza virus test negative
Clinical narrative: Patient stated she "felt weird" when she woke up at 0500. At 2:00 PM she became weak, it was hard for her to walk. Stated bilateral arms and legs were weak. Reported to her PCP. Flu test (-), sent home. 1/14/14 Back to her PCP. Now only feels weak on (L) side, sent to hosp. for stroke work up.
Age: 57.0
Sex: F
Vaccine: FLU3, FLU3
Symptoms: Muscular weakness, Neuropathy peripheral
Clinical narrative: Patient stated she "felt weird" when she woke up at 0500. At 2:00 PM she became weak, it was hard for her to walk. Stated bilateral arms and legs were weak. Reported to her PCP. Flu test (-), sent home. 1/14/14 Back to her PCP. Now only feels weak on (L) side, sent to hosp. for stroke work up.
Age: 26.0
Sex: F
Vaccine: FLU3, PPV, TDAP
Symptoms: Erythema, Inflammation, Pyrexia, Urticaria
Clinical narrative: (L) arm red and inflamed, got hives, fever.
Sex: U
Vaccine: VARZOS
Symptoms: Incorrect storage of drug, No adverse event
Clinical narrative: Information has been received from a registered nurse regarding a patient of unknown age and gender. On 14-DEC-2012 at 07:45, ZOSTAVAX lot # H016765 was exposed to -14C for an estimated total time out of range of 13.25 hours. On 18-DEC-2012 at 18:30, ZOSTAVAX lot # H016765 was exposed to -14C for an estimated total time out of range of 12.75 hours. On 20-DEC-2012, the patient was vaccinated with an out of range dose of ZOSTAVAX (dose and route administration were not provided) (Lot number H016765). No adverse experience had been reported. This is one of 182 reports from the same source. Additional information has been requested.
Sex: U
Vaccine: VARZOS
Symptoms: Incorrect storage of drug, No adverse event
Clinical narrative: Information has been received from a registered nurse regarding a patient of unknown age and gender. On 14-DEC-2012 at 07:45, ZOSTAVAX lot # H016765 was exposed to -14C for an estimated total time out of range of 13.25 hours. On 18-DEC-2012 at 18:30, ZOSTAVAX lot # H016765 was exposed to -14C for an estimated total time out of range of 12.75 hours. On 18-DEC-2012, the patient was vaccinated with an out of range dose of ZOSTAVAX (dose and route administration were not provided) (Lot number H016765). No adverse experience had been reported. This is one of 182 reports from the same source. Additional information has been requested.
Age: 4.0
Sex: M
Vaccine: DTAP, FLUN3, VARCEL
Symptoms: Erythema, Induration, Local swelling, Pain, Urticaria
Clinical narrative: Pt was given DTaP in right deltoid on 8/22/12. Within 24 hrs pt had 10 x 8 cm area of erythema and induration which was painful. This resolved over 3 days. Interestingly, since then pt will get recurrent swelling and erythema in same area about every 2-3 months. Was seen by Allergist who diagnosed pt with recall urticaria secondary to DTaP.
Age: 4.0
Sex: M
Vaccine: DTAP, FLUN3, VARCEL
Symptoms: Vaccination complication
Clinical narrative: Pt was given DTaP in right deltoid on 8/22/12. Within 24 hrs pt had 10 x 8 cm area of erythema and induration which was painful. This resolved over 3 days. Interestingly, since then pt will get recurrent swelling and erythema in same area about every 2-3 months. Was seen by Allergist who diagnosed pt with recall urticaria secondary to DTaP.
Age: 54.0
Sex: F
Vaccine: TD
Symptoms: Injection site cellulitis
Clinical narrative: Cellulitis Lt upper arm (Td given because of cellulitis rt greate toe following pedicure).
Age: 38.0
Sex: M
Vaccine: TDAP
Symptoms: Injection site pain, Injection site swelling
Clinical narrative: Swelling and pain to site area and under arm (left arm).
Sex: U
Vaccine: VARZOS
Symptoms: Incorrect storage of drug, No adverse event
Clinical narrative: Information has been received from a registered nurse regarding a patient of unknown age and gender. On 14-DEC-2012 at 07:45, ZOSTAVAX lot # H016765 was exposed to -14C for an estimated total time out of range of 13.25 hours. On 18-DEC-2012 at 18:30, ZOSTAVAX lot # H016765 was exposed to -14C for an estimated total time out of range of 12.75 hours. On 21-DEC-2012, the patient was vaccinated with an out of range dose of ZOSTAVAX (dose and route administration were not provided) (Lot number H016765). No adverse experience had been reported. This is one of 182 reports from the same source. Additional information has been requested.
Sex: U
Vaccine: VARZOS
Symptoms: Incorrect storage of drug, No adverse event
Clinical narrative: Information has been received from a registered nurse regarding a patient of unknown age and gender. On 03-MAR-2012 at 11:30am, ZOSTAVAX, lot # 072477/1604AA was exposed to -12 C for an estimated total time out of range of 4 hours. On 23-MAR-2012, the patient was administered an out of range dose of ZOSTAVAX, lot# 672477/1604AA, expiration date: 13-JAN-2013 (dose and route were not reported). No adverse experience had been reported. This is one of 182 reports from the same source. Additional information has been requested.
Sex: U
Vaccine: VARZOS
Symptoms: Incorrect storage of drug, No adverse event
Clinical narrative: Information has been received from a registered nurse regarding an unknown age and gender patient. On 03-MAR-2012 at 11:30am, ZOSTAVAX, lot # 672477/1604AA was exposed to -12 C for an estimated total time out of range of 4 hours. On 23-MAR-2012, the patient was administered an out of range dose of ZOSTAVAX, lot# 1604AA, expiration date: 13-JAN-2013 (dose and route were not reported). No adverse experience had been reported. This is one of 182 reports from the same source. Additional information has been requested.
Sex: U
Vaccine: VARZOS
Symptoms: Incorrect storage of drug, No adverse event
Clinical narrative: Information has been received from a registered nurse regarding a patient of unknown age and gender. On 14-DEC-2012 at 7:45, ZOSTAVAX lot # H016765 was exposed to -14C for an estimated total time out of range of 13.25 hours. On 18-DEC-2012 at 18:30, ZOSTAVAX lot # H016765 was exposed to -14C for an estimated total time out of range of 12.75 hours. On 22-DEC-2012 at 18:30, ZOSTAVAX lot # H016765 was exposed to -14C for an estimated total time out of range of 5 hours. On 07-JAN-2013, the patient was vaccinated with an out of range dose of ZOSTIVAX (dose and route administration were not provided) (Lot number H016765). No adverse experience had been reported. This is one of 182 reports from the same source. Additional information has been requested.
Age: 59.0
Sex: M
Vaccine: FLU4
Symptoms: Pain
Clinical narrative: Patient experiencing sharp pains down right arm - experienced after flu shot primarily at night. Pt was going to PCP following my recommendation.
Age: 65.0
Sex: F
Vaccine: PPV
Symptoms: Henoch-Schonlein purpura, Injection site erythema, Injection site nodule, Injection site warmth, Local reaction
Clinical narrative: Patient had a local vascular reaction. Had redness, knot, fever around injection site upper left deltoid. DX: Allergic purpura.