chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 69.0
Sex: M
Vaccine: TYP
Symptoms: Rash, Rash erythematous
Clinical narrative: Flat dark red rash on both legs below the knees. No other symptoms, rash does not itch, no discomfort. Pt states his dermatologist is not concerned, no treatment needed at this time.
Age: 38.0
Sex: F
Vaccine: FLU3
Symptoms: Injected limb mobility decreased, Injection site pain, Pain in extremity, X-ray normal
Clinical narrative: Flu shot administered in left shoulder felt pain which never went away.  The pain grew more and more intense and pain went down my left arm.  I began to lose range of motion in arm. Went to see doctor on 11/13/2014 at that time had xray and was referred to a physiatrist. Appointment was 12/5/2014 received a cortisone shot and prescribed PT. Still in PT as of 2/17/2015.
Age: 1.42
Sex: M
Vaccine: MMR
Symptoms: Lymphadenopathy
Clinical narrative: Swollen glands on left side of neck.
Age: 4.0
Sex: M
Vaccine: DTAP, MMR
Symptoms: Injection site erythema, Injection site movement impairment, Injection site swelling, Pyrexia, Rash generalised
Clinical narrative: Fever of 101-103 which lasted on and off until 02/15, largely swollen and red leg (not only at injection site), immobility of leg for 3 days after vaccine. Fever broke on 02/15 and bodily rash occurred.
Age: 73.0
Sex: F
Vaccine: DTAP
Symptoms: Local swelling, Mass, Pain, Pruritus, Tenderness
Clinical narrative: Local swelling, severe pain, itching. Tender lump.
Age: 0.17
Sex: M
Vaccine: DTAPIPVHIB, PNC13, RV5
Symptoms: Convulsion, Screaming
Clinical narrative: Daughter started screaming and had to be admitted to hospital.  She was diagnosed with seizures.
Age: 6.0
Sex: M
Vaccine: FLUX
Symptoms: Erythema, Rash erythematous, Rash generalised, Swelling face
Clinical narrative: Generalized erythematous body rash and facial swelling redness. Regressed within 24 hours or so. Given Benadryl.
Age: 66.0
Sex: F
Vaccine: PNC13, VARZOS
Symptoms: Chills, Erythema, Headache, Influenza like illness, Joint range of motion decreased
Clinical narrative: 4"x 5" redness and swelling, decreased ROM, flu-like symptoms including nausea, headache, chills with shaking, muscle aches and pain.
Age: 66.0
Sex: F
Vaccine: PNC13, VARZOS
Symptoms: Myalgia, Nausea, Swelling
Clinical narrative: 4"x 5" redness and swelling, decreased ROM, flu-like symptoms including nausea, headache, chills with shaking, muscle aches and pain.
Age: 63.0
Sex: F
Vaccine: VARZOS, VARZOS
Symptoms: Erythema, Peripheral swelling, Pruritus, Rash, Rash vesicular
Clinical narrative: Swollen arm, red, rashy, hot and itchy arm all reported to manufacturer on 2/10.  Went to visit doctor 2 days later and Dr said to take antihistamines and that this happens to about 1 in 3 patients. Patient now reporting (2/17/2015) that it looks like she has chicken pox in certain areas under he breasts and arm.
Age: 63.0
Sex: F
Vaccine: VARZOS, VARZOS
Symptoms: Skin warm
Clinical narrative: Swollen arm, red, rashy, hot and itchy arm all reported to manufacturer on 2/10.  Went to visit doctor 2 days later and Dr said to take antihistamines and that this happens to about 1 in 3 patients. Patient now reporting (2/17/2015) that it looks like she has chicken pox in certain areas under he breasts and arm.
Age: 63.0
Sex: F
Vaccine: VARZOS, VARZOS
Symptoms: Injection site nodule, Injection site pruritus
Clinical narrative: Swollen arm, red, rashy, hot and itchy arm all reported to manufacturer on 2/10.  Went to visit doctor 2 days later and Dr said to take antihistamines and that this happens to about 1 in 3 patients. Patient now reporting (2/17/2015) that it looks like she has chicken pox in certain areas under he breasts and arm.
Age: 1.5
Sex: F
Vaccine: DTAP, HIBV, VARCEL
Symptoms: Injection site erythema, Injection site induration, Injection site pustule, Injection site rash
Clinical narrative: Mom reports onset of a rash around the injection site on left leg. Area is firm under skin with small, raised pustules.
Age: 0.35
Sex: M
Vaccine: DTAPIPVHIB, HEP, PPV, RVX
Symptoms: Crying, Fatigue, Screaming
Clinical narrative: Screamed and cried non-stop for 4 hours.  (only stopped when exhausted to rest/sleep only for a few minutes and then woke up screaming again.)
Age: 67.0
Sex: M
Vaccine: VARZOS
Symptoms: Injection site erythema, Injection site pruritus, Injection site swelling
Clinical narrative: Redness, swelling and the injection site.  No treatment given.  Red area later became itchy.
Age: 15.0
Sex: F
Vaccine: HPVX, IPV, MMR
Symptoms: Syncope
Clinical narrative: She received her vaccine, went to the restroom to urinate, and upon attempting to return to the exam room, fainted in the hallway.
Age: 69.0
Sex: F
Vaccine: VARZOS
Symptoms: Cellulitis, Erythema, Pain in extremity, Peripheral swelling
Clinical narrative: On Sat. 2/14/15 patient came back with red, swollen arm that was very painful, went to doctor and Dr said it was cellulitis.
Age: 21.0
Sex: M
Vaccine: IPV
Symptoms: Local swelling, Rash, Rash erythematous, Rash pruritic
Clinical narrative: Itchy red rash on chest/swelling in neck.
Age: 2.0
Sex: F
Vaccine: MMR
Symptoms: Abdominal pain upper, Blood test, Constipation, Nuclear magnetic resonance imaging, Pain in extremity
Clinical narrative: Constipation/stomach pain followed by severe pain in hands and feet that progressively worsened. Diagnosis concluded possible post viral illness. No treatment despite various drugs has been effective in reducing pain or inducing sleep.
Age: 2.0
Sex: F
Vaccine: MMR
Symptoms: Ultrasound scan
Clinical narrative: Constipation/stomach pain followed by severe pain in hands and feet that progressively worsened. Diagnosis concluded possible post viral illness. No treatment despite various drugs has been effective in reducing pain or inducing sleep.
Age: 1.06
Sex: F
Vaccine: MMR
Symptoms: Cerebral palsy, Craniocerebral injury, Pyrexia, Seizure
Clinical narrative: Convulsion.  Taken to Hospital.
Age: 26.0
Sex: F
Vaccine: HEPAB
Symptoms: Dermatitis, Dermatitis allergic
Clinical narrative: Severe dermatitis and multiple skin allergies.
Age: 11.0
Sex: F
Vaccine: FLUN4, HEP, HPV4, IPV, MNQ, TDAP
Symptoms: Slow response to stimuli, Syncope
Clinical narrative: Client received Tdap, IPV, Hep B, MCV4, Flumist and HPV4. After HPV4 was administered (which was the last vaccine that was administered, client had syncope episode, client responded within 15secs. Lowered client to floor, elevated legs, juice given. After 10 mins. client stated she was feeling better, asissted her to chair where she finished juice. 3:00pm client had another syncope episode, lowered her to floor and administered O2, client orinated but slow to respond. 911 called, Paramedics transferred client to the hospital.
Age: 23.0
Sex: F
Vaccine: HEP
Symptoms: Pharyngeal oedema, Sensation of foreign body, Throat irritation
Clinical narrative: Had first of the hep B immunizations and within 10 minutes felt a swelling/lump develop and a "scratchiness" in her throat; had her take 50 mg Benadryl and drank 16+ oz water; monitored and scratchiness went away completely within 45 minutes; pt left the clinic and went home. She does have access to an Epi-pen her husband has in the home.
Age: 38.0
Sex: F
Vaccine: FLU3, TDAP, FLU3, TDAP
Symptoms: Joint range of motion decreased, Joint stiffness, Pain in extremity, Paraesthesia
Clinical narrative: Soreness/tightness in arm, difficulty lifting arm, limited range of motion, and tingling sensation in middle and ring finger in affected arm.
Age: 38.0
Sex: F
Vaccine: FLU3, TDAP, FLU3, TDAP
Symptoms: Joint range of motion decreased, Mobility decreased, Pain in extremity, Paraesthesia, Skin tightness
Clinical narrative: Soreness/tightness in arm, difficulty lifting arm, limited range of motion, and tingling sensation in middle and ring finger in affected arm.
Age: 51.0
Sex: F
Vaccine: ANTH
Symptoms: Abdominal pain upper, Arthralgia, Blood test, Diagnostic procedure, Diarrhoea
Clinical narrative: Hot, sore - by the next day headache. Onset of body pain, joint pain, nausea, vomiting, diarrhea.  RUQ pain - felt like gallbladder dysfunction.  GB dysfunction is being ruled out - fatigue, concentration deficit, myalgia, numbness and tingling.
Age: 51.0
Sex: F
Vaccine: ANTH
Symptoms: Disturbance in attention, Fatigue, Feeling hot, Headache, Hypoaesthesia
Clinical narrative: Hot, sore - by the next day headache. Onset of body pain, joint pain, nausea, vomiting, diarrhea.  RUQ pain - felt like gallbladder dysfunction.  GB dysfunction is being ruled out - fatigue, concentration deficit, myalgia, numbness and tingling.
Age: 51.0
Sex: F
Vaccine: ANTH
Symptoms: Myalgia, Nausea, Pain, Paraesthesia, Ultrasound scan
Clinical narrative: Hot, sore - by the next day headache. Onset of body pain, joint pain, nausea, vomiting, diarrhea.  RUQ pain - felt like gallbladder dysfunction.  GB dysfunction is being ruled out - fatigue, concentration deficit, myalgia, numbness and tingling.
Age: 51.0
Sex: F
Vaccine: ANTH
Symptoms: Vomiting
Clinical narrative: Hot, sore - by the next day headache. Onset of body pain, joint pain, nausea, vomiting, diarrhea.  RUQ pain - felt like gallbladder dysfunction.  GB dysfunction is being ruled out - fatigue, concentration deficit, myalgia, numbness and tingling.
Age: 1.42
Sex: M
Vaccine: MMR, MMR
Symptoms: Blood test normal, Febrile convulsion
Clinical narrative: Febrile Seizure.
Age: 1.42
Sex: M
Vaccine: MMR, MMR
Symptoms: Body temperature increased, Febrile convulsion
Clinical narrative: Febrile Seizure.
Age: 16.0
Sex: M
Vaccine: HPV4, MNQ
Symptoms: Central nervous system inflammation, Labyrinthitis, Nuclear magnetic resonance imaging abnormal, Vertigo
Clinical narrative: Developed severe vertigo 2 days after vaccination with HPV and MCV.  Diagnosed with presumed labyrinthitis, given a course of prednisone without significant improvement.  Saw ENT, referred for MRI (see below).
Age: 10.0
Sex: F
Vaccine: DTP, MMRV
Symptoms: Rash, Urticaria
Clinical narrative: Severe rash/hives.
Sex: U
Vaccine: FLU3
Symptoms: Cellulitis, Hypersensitivity
Clinical narrative: Case number PHEH2015US002854 is an initial spontaneous report from a consumer via pharmacy claims received on 09 Feb 2015. This report refers to a patient of an unknown age and gender. The patient was vaccinated with FLUVIRIN (batch number: 1411001, expiry date: Apr 2015) on an unknown date. On 27 Aug 2014, after vaccination the patient experienced an allergic reaction and also had cellulitis. The outcome, seriousness and causality of the events were not reported. Seriousness assessment of the event (cellulitis) was upgraded based on the available information in the source document.
Age: 51.0
Sex: F
Vaccine: FLU3
Symptoms: Arthralgia, Bursitis, Drug administration error, Nuclear magnetic resonance imaging abnormal, Tendonitis
Clinical narrative: Case number PHEH2015US003035 is a combined initial and follow up spontaneous report received from a physician on 09 Feb 2015 and from a consumer on 11 Feb 2015. This report refers to a 51-year-old female patient. She was vaccinated with FLUVIRIN (batch number: 14621P) intramuscularly on 22 Oct 2014. It was reported that the vaccine was administered incorrectly to the patient and she experienced bursitis on the same date. On 05 Nov 2014, 2 weeks after vaccination she experienced an ongoing pain in arm at shoulder joint. MRI of her arm showed severe tendonitis. The final outcome of the events was unknown. The seriousness and causality of the events were not reported. Seriousness assessment of the events (tendonitis, arthralgia and bursitis) was upgraded based on the available information in the source document.
Age: 74.0
Sex: M
Vaccine: FLUX, PPV
Symptoms: Chest X-ray normal, Computerised tomogram head normal, Echocardiogram abnormal, Ejection fraction normal, Electrocardiogram normal
Clinical narrative: Case number# PHHY2015US016295, is an initial report received from a physician on 05 Feb 2015. This report refers to a 74 year old male patient. Medical History was not reported. Concurrent conditions included impaired fasting glucose, hypothyroidism, gastrooesophageal reflux disease, osteopenia, seasonal allergy and erectile dysfunction. This polymedicated patient received DIOVAN for the treatment of hypertension from an unknown date in 2009 at a dose of 320 mg, QD (oral). The patient received influenza vaccine on 23 Sep 2014 at a dose of 1 DF single (intramuscular). This patient also received pneumococcal vaccine on 23 Sep 2014 at an unknown dose (blinded). On 23 Sep 2014, in the evening the patient was walking across the room, he collapsed, fell backwards and struck his head he was awakened less than a minute by his wife and rescue was called, then he was transferred to emergency room (hospitalized on 24 Sep 2014), full work up done, including cardiac work up with negative serial enzymes x3. ECG (electrocardiogram) was normal and lab results were unremarkable. Chest X ray showed no acute cardio pulmonary disease, Echocardiogram showed ejection fraction of 60-65%. CT (computerized tomogram) head was normal. Final diagnosis was vasovagal syncope. On 25 Sep 2014, the patient was hydrated and discharged. No medication changes were made. In response to the events DIOVAN was temporarily withdrawn on an unknown date in 2014. The event stopped on an unknown date in 2014. The event did not reoccur and on an unknown date in 2014, the patient resumed the treatment with DIOVAN. On 22 Oct 2014 an additional dose of blinded therapy was administered at 1DF single dose. Outcome of the event syncope was reported as complete recovery on 25 Sep 2014. Causality of the event syncope was reported as related (suspected) to DIOVAN. Outcome and causality of the event fall was not reported.
Age: 74.0
Sex: M
Vaccine: FLUX, PPV
Symptoms: Fall, Head injury, Laboratory test normal, Loss of consciousness, Myocardial necrosis marker normal
Clinical narrative: Case number# PHHY2015US016295, is an initial report received from a physician on 05 Feb 2015. This report refers to a 74 year old male patient. Medical History was not reported. Concurrent conditions included impaired fasting glucose, hypothyroidism, gastrooesophageal reflux disease, osteopenia, seasonal allergy and erectile dysfunction. This polymedicated patient received DIOVAN for the treatment of hypertension from an unknown date in 2009 at a dose of 320 mg, QD (oral). The patient received influenza vaccine on 23 Sep 2014 at a dose of 1 DF single (intramuscular). This patient also received pneumococcal vaccine on 23 Sep 2014 at an unknown dose (blinded). On 23 Sep 2014, in the evening the patient was walking across the room, he collapsed, fell backwards and struck his head he was awakened less than a minute by his wife and rescue was called, then he was transferred to emergency room (hospitalized on 24 Sep 2014), full work up done, including cardiac work up with negative serial enzymes x3. ECG (electrocardiogram) was normal and lab results were unremarkable. Chest X ray showed no acute cardio pulmonary disease, Echocardiogram showed ejection fraction of 60-65%. CT (computerized tomogram) head was normal. Final diagnosis was vasovagal syncope. On 25 Sep 2014, the patient was hydrated and discharged. No medication changes were made. In response to the events DIOVAN was temporarily withdrawn on an unknown date in 2014. The event stopped on an unknown date in 2014. The event did not reoccur and on an unknown date in 2014, the patient resumed the treatment with DIOVAN. On 22 Oct 2014 an additional dose of blinded therapy was administered at 1DF single dose. Outcome of the event syncope was reported as complete recovery on 25 Sep 2014. Causality of the event syncope was reported as related (suspected) to DIOVAN. Outcome and causality of the event fall was not reported.
Age: 74.0
Sex: M
Vaccine: FLUX, PPV
Symptoms: Syncope
Clinical narrative: Case number# PHHY2015US016295, is an initial report received from a physician on 05 Feb 2015. This report refers to a 74 year old male patient. Medical History was not reported. Concurrent conditions included impaired fasting glucose, hypothyroidism, gastrooesophageal reflux disease, osteopenia, seasonal allergy and erectile dysfunction. This polymedicated patient received DIOVAN for the treatment of hypertension from an unknown date in 2009 at a dose of 320 mg, QD (oral). The patient received influenza vaccine on 23 Sep 2014 at a dose of 1 DF single (intramuscular). This patient also received pneumococcal vaccine on 23 Sep 2014 at an unknown dose (blinded). On 23 Sep 2014, in the evening the patient was walking across the room, he collapsed, fell backwards and struck his head he was awakened less than a minute by his wife and rescue was called, then he was transferred to emergency room (hospitalized on 24 Sep 2014), full work up done, including cardiac work up with negative serial enzymes x3. ECG (electrocardiogram) was normal and lab results were unremarkable. Chest X ray showed no acute cardio pulmonary disease, Echocardiogram showed ejection fraction of 60-65%. CT (computerized tomogram) head was normal. Final diagnosis was vasovagal syncope. On 25 Sep 2014, the patient was hydrated and discharged. No medication changes were made. In response to the events DIOVAN was temporarily withdrawn on an unknown date in 2014. The event stopped on an unknown date in 2014. The event did not reoccur and on an unknown date in 2014, the patient resumed the treatment with DIOVAN. On 22 Oct 2014 an additional dose of blinded therapy was administered at 1DF single dose. Outcome of the event syncope was reported as complete recovery on 25 Sep 2014. Causality of the event syncope was reported as related (suspected) to DIOVAN. Outcome and causality of the event fall was not reported.
Sex: F
Vaccine: VARCEL
Symptoms: Foetal exposure during pregnancy, Premature baby
Clinical narrative: Information has been received for VARIVAX (Merck) from a registered nurse concerning a neonate female patient whose mother was a 21 year old female patient who was non-smoker, and non-drug/alcohol user, had no known drug allergies and was infected with a sexually transmitted disease (STD) (prospective pregnancy report). Patient's mother date of last menstrual period (LMP) was 15-JAN-2014. Approximately on 29-JAN-2014 (reported as the estimated date of conception) the patient's mother became pregnant. On 22-MAY-2014 at 15:00 the patient's mother received a dose of VARIVAX (Merck), 0.5 ml, subcutaneous in the right arm, lot # J012376, expiry date 03-OCT-2015. It was not reported if the patient's mother received Tdap. The patient's mother concomitant medication included "prenatal vitamins" (unspecified). The estimated date of delivery (EDD) was 22-OCT-2014. On 15-AUG-2014, at 30 gestation weeks, the patient was delivered as a premature live infant with 2 lbs. and 2 oz. of weight and 15 in of length. Appearance, Pulse, Grimace, Activity, Respiration (APGAR) score and head circumference measures were unknown. The patient was born normal and there were no congenital anomalies. The outcome of premature birth was unknown. This is one of two reports received from the same source (parent-child link MARRS # 1405USA015646). Additional information has been requested.
Age: 0.4
Sex: M
Vaccine: RV5
Symptoms: Inappropriate schedule of drug administration, No adverse event
Clinical narrative: This spontaneous report as received from a physician refers to a 4 month and 8 day old male patient. The patient concurrent conditions and medical history was not reported. On 16-FEB-2015 the patient was vaccinated with first dose of ROTATEQ (Dose/Frequency: 2 ml and Route: oral). No adverse effects were reported. No product quality complaint (PQC) was reported for ROTATEQ. Additional information is not expected as the reporter did not wish to contact.
Age: 1.07
Sex: F
Vaccine: MMR, VARCEL
Symptoms: Pyrexia, Rash erythematous
Clinical narrative: 48 degrees after MMR and Varicella- developed 4 days of fever, 104 Tmax. 4 days after injection red rash on torso-self-resolved.
Age: 12.0
Sex: F
Vaccine: FLU4
Symptoms: Activities of daily living impaired, Grip strength decreased, Hypoaesthesia, Hypoaesthesia oral, Vomiting
Clinical narrative: Pt woke up 2/17/15 saying her tongue was numb and her right leg was numb. She also said she couldn't grip her brush with her right hand and the numbness traveled up to her right eye. Pt also vomited twice and was sent home from school the morning of 2/17/15.
Sex: U
Vaccine: RV5
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report as received from a licensed vocational nurse refers to an unknown number of patients of unknown age and gender. The patients medical history and concurrent conditions were not provided. On unknown dates since 23-JAN-2015, the patients were vaccinated with ROTATEQ, per oral (lot # and expiration dates were not provided). Concomitant medication information was not provided. On unknown dates since 23-JAN-2015, the patients had been administered ROTATEQ which underwent supported temperature excursions. No adverse effects were reported. It was unknown if the patients sought medical attention. At the time of the report, the patients status was unknown. This is one of several reports received from the same source. Additional information has been requested.
Age: 60.0
Sex: F
Vaccine: FLUX
Symptoms: Dyspnoea, Respiratory tract inflammation, Swelling face, Urticaria
Clinical narrative: This case was reported by a consumer and described the occurrence of body hives in a 60-year-old female subject who was vaccinated with Influenza vaccine (unspecified manufacturer). A physician or other health care professional has not verified this report. In 2004, the subject received unspecified dose of Influenza vaccine (unspecified) (unknown route, unknown arm and batch number). In 2004, 6 to 8 hours after vaccination with Influenza vaccine (unspecified), the subject experienced body hives, face swollen, shortness of breath, lung inflammation. The subject was treated with BENADRYL, CORITSOL and prednisone. The events were resolved and lasted a couple of days. She was told at that time to not get the Flu vaccine again but she got the flu one year and it was bad. She received 2 separate half doses of Flu vaccine for the last 2 years. She received a half of dose and then went back in about a week and received another half dose. Prior to this, she got the Flu vaccine in 4 injections every half hour. She stated her doctors have titrated her Flu dose in the past and this works well for her.
Age: 54.0
Sex: F
Vaccine: FLU4
Symptoms: Injection site erythema, Injection site pain, Injection site paraesthesia, Injection site warmth, Insomnia
Clinical narrative: This case was reported by a healthcare professional and described the occurrence of injection site redness in a 54-year-old female subject who was vaccinated with FLUARIX QUADRIVALENT (GlaxoSmithKline). The subject's medical history included injection site reactions with previous flu shots but not as intense as this injection. On 10 September 2014, at 14:00, the subject received 1st dose of FLUARIX QUADRIVALENT (.5 ml, other, left deltoid) which led to a maladministration (expired vaccine used). The vaccine was expired since 30 June 2014. On 10 September 2014, less than one day after vaccination with FLUARIX QUADRIVALENT, the subject experienced redness, warm sensation, arm pain and tingling in arm, all at injection site. Symptoms became worse at night and the subject found it hard to sleep because of the symptoms. The subject was treated with BENADRYL and cortisone. At the time of reporting, all the events were improved (there was some relief), except the tingling in arm at the injection site which was unresolved. The healthcare professional considered the events were probably related to vaccination with FLUARIX QUADRIVALENT. This is one of the 2 cases reported by the same reporter for the same vaccine. See case A1089070A for more details. Follow-up information received on 16 September 20214: The expired date of the vaccine had been updated 30 June 2015. Then, no expired vaccine was used.
Age: 43.0
Sex: M
Vaccine: FLU4
Symptoms: Hypertension, Tachycardia
Clinical narrative: This case was reported by a healthcare professional via a sales representative and described the occurrence of hypertension in a 43-year-old male subject who was vaccinated with FLUARIX QUADRIVALENT (GlaxoSmithKline). The subject had none relevant medical history or concomitant medications none, has received previously flu shots the subject had none document reactions experienced with previous flu shots or any adverse events following previous vaccinations. On 15 September 2014, the subject received 1st dose of FLUARIX QUADRIVALENT (.5 ml, unknown route, right arm), which was the only vaccination received on that day. On 15 September 2014, within 1 hour after vaccination with FLUARIX QUADRIVALENT, the subject experienced hypertension and tachycardia. The subject was treated with TYLENOL and BENADRYL. At the time of reporting the events were resolved. The healthcare professional considered the events were hypertension was possibly related to vaccination with FLUARIX QUADRIVALENT and tachycardia was probably related to vaccination with FLUARIX QUADRIVALENT. This was one of the 3 reports received from the same field representative, and all 3 subjects were employees of the health system or facility.
Age: 46.0
Sex: M
Vaccine: FLU4
Symptoms: Condition aggravated, Hypertension, Tachycardia
Clinical narrative: This case was reported by a healthcare professional via a sales representative and described the occurrence of tachycardia in a 46-year-old male subject who was vaccinated with FLUARIX QUADRIVALENT (GlaxoSmithKline). Concurrent medical conditions included hypertension for which the subject was treated with Antihypertensive (Hypertension med). The subject has received previously flu shot the subject had none document reactions experienced with previous flu shots or any adverse events following previous vaccinations. On 15 September 2014, the subject received 1st dose of FLUARIX QUADRIVALENT (.5 ml, unknown route, right arm). On 15 September 2014, about 2 hours after vaccination with FLUARIX QUADRIVALENT, the subject experienced tachycardia and hypertension aggravated. The subject was treated with TYLENOL and BENADRYL. On 15 September 2014, the events were resolved. The healthcare professional considered the tachycardia was probably related to vaccination with FLUARIX QUADRIVALENT and the hypertension was unrelated to vaccination with FLUARIX QUADRIVALENT. This was one of the 3 reports received from the same field representative, and all 3 subjects were employees of the health system or facility.
Age: 60.0
Sex: F
Vaccine: FLU4
Symptoms: Altered state of consciousness, Blood pressure increased, Flushing, Injection site erythema
Clinical narrative: This case was reported by a healthcare professional and described the occurrence of felt like passing out in a 60-year-old female subject who was vaccinated with FLUARIX, (GlaxoSmithKline). On 11 September 2014, the subject received 1st dose of FLUARIX (.5 ml, other, left deltoid). On 11 September 2014, less than one day after vaccination with FLUARIX, the subject experienced felt like passing out, feeling flushed and injection site redness. Her blood pressure was checked 3 times and was elevated. The subject was treated with BENADRYL which helped the redness. At the time of reporting, the events were improved. The healthcare professional considered the events were probably related to vaccination with FLUARIX. This is one of the 2 cases reported by the same reporter for the same vaccine. See case A1089073A for more details.
Sex: F
Vaccine: FLUX
Symptoms: Extensive swelling of vaccinated limb, Injection site erythema, Injection site pain, Injection site swelling, Injection site warmth
Clinical narrative: This case was reported by a healthcare professional and described the occurrence of extensive swelling of vaccinated limb in a female subject of unspecified age who was vaccinated with influenza vaccine quadrivalent (manufacturer unspecified). On an unspecified date, the subject received unspecified dose of Influenza vaccine Quadrivalent (unknown route and injection site; lot number not provided). Within 20 minutes after vaccination with Influenza vaccine Quadrivalent, the subject experienced extensive swelling of vaccinated limb, the injection site was red, hot and painful. At the time of reporting the injection site had a swelling of approximately 11 x 6 cm in size and it was still warm and pink. At the time of reporting the events were unresolved.
Age: 12.0
Sex: F
Vaccine: TDAP, TDAP
Symptoms: Acoustic stimulation tests, Dizziness, Headache, Influenza virus test negative, Lethargy
Clinical narrative: Headache. Fever of 103 pulse 110. Dizziness BP 125/80. Rash on torso. Hives-neck and back "Lump" in throat. Ears ringing. Lethargy. Pallor.
Age: 12.0
Sex: F
Vaccine: TDAP, TDAP
Symptoms: Pallor, Pyrexia, Rash, Sensation of foreign body, Streptococcus test negative
Clinical narrative: Headache. Fever of 103 pulse 110. Dizziness BP 125/80. Rash on torso. Hives-neck and back "Lump" in throat. Ears ringing. Lethargy. Pallor.
Age: 12.0
Sex: F
Vaccine: TDAP, TDAP
Symptoms: Tinnitus, Urticaria
Clinical narrative: Headache. Fever of 103 pulse 110. Dizziness BP 125/80. Rash on torso. Hives-neck and back "Lump" in throat. Ears ringing. Lethargy. Pallor.
Age: 12.0
Sex: F
Vaccine: TDAP, TDAP
Symptoms: Unevaluable event
Clinical narrative: Headache. Fever of 103 pulse 110. Dizziness BP 125/80. Rash on torso. Hives-neck and back "Lump" in throat. Ears ringing. Lethargy. Pallor.
Sex: M
Vaccine: FLU3
Symptoms: Pain in extremity
Clinical narrative: This case was reported by a consumer via Merck and described the occurrence of arm soreness in a male subject of unspecified age who was vaccinated with FLUARIX (GlaxoSmithKline). A physician or other health care professional has not verified this report. In 2013, the subject received unspecified dose of FLUARIX (unknown route and injection site: lot number not provided). At an unspecified time after vaccination with FLUARIX, the subject experienced arm soreness. At the time of reporting the event was unresolved. No further information was provided.
Sex: F
Vaccine: FLU3
Symptoms: Adverse reaction
Clinical narrative: This case was reported by a consumer and described the occurrence of adverse reaction in a female subject of unspecified age who was vaccinated with Influenza vaccine (GlaxoSmithKline). A physician or other health care professional has not verified this report. On an unspecified date, years and years ago, the subject received unspecified dose of Influenza vaccine (unknown route and injection site; lot number not provided). At an unspecified time after vaccination with Influenza vaccine , the subject experienced adverse reaction (she not wish to specify when or what kind of reaction). At the time of reporting the outcome of the event was unspecified.
Sex: U
Vaccine: FLU4
Symptoms: Arthralgia
Clinical narrative: This case was reported by a physician and described the occurrence of arthralgia in a adult patient who received FLUARIX QUADRIVALENT. On an unknown date, the patient received FLUARIX QUADRIVALENT at an unknown dose. On an unknown date, unknown after receiving FLUARIX QUADRIVALENT, the patient experienced arthralgia. On an unknown date, the outcome of the arthralgia was unknown. It was unknown if the reporter considered the arthralgia to be related to FLUARIX QUADRIVALENT. This case is one of the 10 cases reported by the same reporter for the same vaccine. Additional information received: MD updating previous AE report of shoulder arthralgia in 10 patients following vaccination with FLUARIX QIV, with lot number and expiration date info. He was unable to obtain more information on the patients, though he states that they were all adults.
Sex: U
Vaccine: FLU4
Symptoms: Arthralgia
Clinical narrative: This case was reported by a physician and described the occurrence of arthralgia in a adult patient who received FLUARIX QUADRIVALENT (batch number LY2F5, expiry date 30th June 2015). On an unknown date, the patient received FLUARIX QUADRIVALENT. On an unknown date, unknown after receiving FLUARIX QUADRIVALENT, the patient experienced arthralgia. On an unknown date, the outcome of the arthralgia was unknown. It was unknown if the reporter considered the arthralgia to be related to FLUARIX QUADRIVALENT. This case is one of the 10 cases reported by the same reporter for the same vaccine. Additional information received: MD updating previous AE report of shoulder arthralgia in 10 patients following vaccination with FLUARIX QIV, with lot number and expiration date info. He was unable to obtain more information on the patients, though he states that they were all adults.
Sex: U
Vaccine: FLU4
Symptoms: Arthralgia
Clinical narrative: This case was reported by a physician and described the occurrence of arthralgia in a adult patient who received FLUARIX QUADRIVALENT (batch number LY2F5, expiry date 30th June 2015). On an unknown date, the patient received FLUARIX QUADRIVALENT. On an unknown date, unknown after receiving FLUARIX QUADRIVALENT, the patient experienced arthralgia. On an unknown date, the outcome of the arthralgia was unknown. It was unknown if the reporter considered the arthralgia to be related to FLUARIX QUADRIVALENT. Additional information received; MD updating previous AE report of shoulder arthralgia in 10 patients following vaccination with FLUARIX QIV, with lot number and expiration date info. He was unable to obtain more information on the patients, though he states that they were all adults.
Age: 0.72
Sex: F
Vaccine: DTAPIPVHIB, PNC13, RV5
Symptoms: Rash pruritic, Urticaria
Clinical narrative: Hives that appeared 2 hours after receiving vaccines according to child's father. States the rash was itchy. Given BENADRYL and Triamcinolone cream.
Sex: U
Vaccine: HIBV
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report was received from a nurse practitioner concerning an unspecified number of patients of unknown age and gender. On an unknown date the patients were vaccinated with improperly stored PEDVAX HIB (dose, lot number and expiration date were not provided). Concomitant medications were not reported. No adverse effects were reported and there was no product quality complaint involved. This is one of several reports received from the same source. Additional information has been requested.
Age: 12.0
Sex: U
Vaccine: TDAP
Symptoms: Extra dose administered
Clinical narrative: This case was reported by a other health professional via call center representative and described the occurrence of extra dose administered in a 12-year-old unk patient who received BOOSTRIX (batch number UNK, expiry date unknown). Previously administered products included Tdap. On an unknown date, the patient received BOOSTRIX. On an unknown date, an unknown time after receiving BOOSTRIX, the patient experienced extra dose administered. On an unknown date, the outcome of the extra dose administered was unknown. Additional information: 12 year old mistakenly given BOOSTRIX after previously receiving another Tdap vaccine within the last year.
Sex: U
Vaccine: HEP
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report was received from a nurse practitioner concerning an unspecified number of patients of unknown age and gender. On an unknown date the patients were vaccinated with improperly stored RECOMBIVAX HB (dose, lot number and expiration date were not provided). Concomitant medications were not reported. No adverse effects were reported and there was no product quality complaint involved. This is one of several reports received from the same source. Additional information has been requested.
Sex: U
Vaccine: VARCEL
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report as received from a nurse refers to a patient of unknown age and gender. On 09-FEB-2015 the patient was vaccinated with VARIVAX (Merck) (0.5 ml, subcutaneously) that underwent two temperature excursions. No adverse effects reported. This is one of several reports received from the same source. Additional information has been requested.
Sex: U
Vaccine: HPV4
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report was received registered nurse refers to a patient of unknown age and gender. On an unknown date the patient was vaccinated with an improperly stored dose of GARDASIL (strength, dose and lot # were not reported). No adverse effects reported. Additional information has been requested.
Sex: M
Vaccine: HPV4
Symptoms: Malaise
Clinical narrative: This spontaneous report as received from the patient's mother, refers to her male son of unknown age. Medical history and concurrent conditions were not reported. On an unknown date the patient, was vaccinated with a dose of GARDASIL (administration route, lot number and expiration date were not reported). No concomitant medications were reported. The patient's mother stated that he son possibly got "sick" after the vaccine was administered, but did not provide any additional information. The outcome of the unspecified sickness was unknown. Additional information is not expected, because there is no contact information to follow up.
Age: 26.0
Sex: F
Vaccine: HPV4
Symptoms: Exposure during pregnancy, No adverse event
Clinical narrative: This spontaneous prospective pregnancy report as received from a Licensed Practical Nurse, refers to a female patient of unknown age. Medical history and concurrent conditions were not reported. On 18-JUN-2014 the patient was vaccinated with the first dose of GARDASIL lot # H019088 and expiration date: 26-JUN-2015. The patient received a second dose on 20-AUG-2014 (lot number: H019088 and expiration date: 26-JUN-2015) and the third one on 17-DEC-2014 (lot number: K011492 and expiration date: 22-JUN-2016) before she discovered that she was pregnant. The patient became pregnant with LMP of 26-NOV-2014 and EDD of 02-SEP-2015. The pregnancy outcome was unknown at the time of the report. No adverse effects were reported. Additional information has been requested.
Age: 60.0
Sex: M
Vaccine: PPV
Symptoms: Inappropriate schedule of drug administration, No adverse event
Clinical narrative: This spontaneous report as received from an approximately 60 year old male consumer reporting on himself. In 2003, the patient was vaccinated with the first dose of PNEUMOVAX 23 (Lot # 645646/0068N exp date 26-NOV-2004) (dose and route not reported) and in 2007, after four years, the patient received the second dose of PNEUMOVAX 23 (Lot # 658075/0962U exp date 30-JAN-2009) (dose and route not reported). No adverse effect was reported. Additional information is not expected. There is no contact information.
Age: 42.0
Sex: F
Vaccine: MMR
Symptoms: Rubella antibody negative
Clinical narrative: This spontaneous report was received from a pharmacist and refers to a 42 year old pregnant female patient. The patient's medical history, concurrent conditions, drug reactions and allergies were not reported. On an unknown date, as a child, the patient was vaccinated with M-M-R II (dose, route of administration, anatomical location, lot# and expiration date were not reported). The number of M-M-R II doses that the patient received and dates of administration were unspecified. Concomitant therapies were not reported. Approximately in January 2015 (reported as "approximately 1 month ago") serologic testing was completed and showed that the patient had no immunity to Rubella. The patient did not seek medical attention and no treatment was given for the event. The patient did not recover from the event. The relatedness between M-M-R II and the event was not reported. Additional information has been requested.
Age: 28.0
Sex: M
Vaccine: DTAP
Symptoms: Overdose, Wrong drug administered
Clinical narrative: This case was reported by a nurse via call center representative and described the occurrence of overdose in a 28-year-old male patient who received INFANRIX. On an unknown date, the patient received INFANRIX. On an unknown date, an unknown time after receiving INFANRIX, the patient experienced overdose. On an unknown date, the outcome of the overdose was unknown. Additional information: INFANRIX mistakenly administered to a 28yo male instead of Tdap.
Sex: U
Vaccine: HEPAB
Symptoms: Inappropriate schedule of drug administration
Clinical narrative: This case was reported by a pharmacist and described the occurrence of drug dose administration interval too long in a patient who received TWINRIX. Previously administered products included TWINRIX (dose 1). On 18th December 2014, the patient received the 2nd dose of TWINRIX. On 18th December 2014, an unknown time after receiving TWINRIX, the patient experienced drug dose administration interval too long. On an unknown date, the outcome of the drug dose administration interval too long was unknown.
Age: 33.0
Sex: U
Vaccine: PPV, RAB
Symptoms: Injection site swelling, Pain, Pain in extremity, Skin abrasion
Clinical narrative: Pt reported feeling "super achy" Fri evening after shot through Sun afternoon. Arm still sore Mon, warm, a little swollen in area of shot. No fever.
Sex: F
Vaccine: VARZOS
Symptoms: Erythema, Headache, Herpes zoster, Tenderness
Clinical narrative: This spontaneous report was received from a female healthcare worker of an unknown age, reporting on herself, via a company representative. Medical history and concurrent conditions were not reported. In July 2012 (reported as two years ago at the end of July or beginning of August 2012), the patient was vaccinated with a dose ZOSTAVAX (dose, dose number, lot number, expiration date and route were not reported). Co-suspect and concomitant therapies were not reported. The healthcare worker reported that on 25-JAN-2015, she experienced headache on the left side of her head that was so bad she almost went to the emergency room. On 29-JAN-2015 (also reported as recently), she saw a little red mark under her bangs. The healthcare worker developed shingles the left side of her head and face: head, forehead, a "few" on her eyelid, and a "few" on her hairline. The healthcare worker described the shingles as "they never oozed or seeped at all, got little bumps and stuff, never blistered and popped, absorbed back into my body and turned really, really red and really, really sore in my head". The healthcare worker reported she has to wash her hair in the sink and with baby shampoo because she "can't stand" the shower on the shingles she also "can't stand" the blow dryer or the curling iron since an unknown date. On 28-JAN-2015, healthcare worker reported that the headache as recovered. At the time of the report the outcome for shingles was not recovered. The healthcare worker stated she seek medical attention on an unspecified healthcare professional and was prescribed with VALTREX for the shingles, on an unknown date. Additional information has been requested.
Age: 78.0
Sex: F
Vaccine: PNC13
Symptoms: Injection site reaction
Clinical narrative: Pt had localized site reaction. Evaluated by provider.
Age: 69.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site reaction, Rash erythematous
Clinical narrative: Red rash at injection site approximate 6 in x 3 in.
Sex: U
Vaccine: MMR
Symptoms: Rash
Clinical narrative: This spontaneous report was received from a certified medical assistant concerning a child patient (reported as pediatric) of an unknown age and gender. Medical history and concurrent conditions were not reported. On 08-JAN-2015, the patient was vaccinated with a dose of MMR II (dose, dose number, lot number, expiration date and route were not reported). Co-suspect and concomitant therapies were not reported. The certified medical assistant reported that on 28-JAN-2015, the patient developed a rash. At the time of the report, the outcome of the rash was unknown. Additional information has been requested.
Age: 2.0
Sex: M
Vaccine: DTAP, HEPA, IPV, MMRV
Symptoms: Injection site rash, Injection site urticaria, Rash, Urticaria
Clinical narrative: Mother reported child developed rash/hives after vaccines given. She states (R) arm was worse. She took child to Hospital and was instructed to continue BENADRYL. (2-12-15).
Sex: U
Vaccine: HPV4
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report was received from a nurse practitioner concerning an unspecified number of patients of unknown age and gender. On an unknown date the patients were vaccinated with improperly stored GARDASIL injection (dose, lot number and expiration date were not provided). Concomitant medications were not reported. No adverse effects were reported and there was no product quality complaint involved. This is one of several reports received from the same source. Additional information has been requested.
Age: 19.0
Sex: F
Vaccine: HPV4
Symptoms: Dizziness, Immediate post-injection reaction, Injection site erythema, Injection site swelling, Musculoskeletal stiffness
Clinical narrative: This spontaneous report as received from a healthcare worker refers to a currently 19 years old female patient with polycystic ovarian syndrome (PCOS) and drug reactions/allergies to amoxicillin. On 31-DEC-2014 the patient was vaccinated with the first dose of GARDASIL (lot # J015378, expiration date 09-APR-2016, dose and frequency not reported). On an unknown date (also reported as reported as immediately) the patient developed fever, nausea, dizziness, stiff back, stiff neck and muscle pains. It was stated that the injection site had swelling and erythema. All events worsened by day three post injection and resolved by day 7 post injection (07-JAN-2015). The patient sought medical attention and contacted the office. The relatedness between the events and GARDASIL was not reported. Additional information has been requested.
Age: 19.0
Sex: F
Vaccine: HPV4
Symptoms: Myalgia, Nausea, Pyrexia
Clinical narrative: This spontaneous report as received from a healthcare worker refers to a currently 19 years old female patient with polycystic ovarian syndrome (PCOS) and drug reactions/allergies to amoxicillin. On 31-DEC-2014 the patient was vaccinated with the first dose of GARDASIL (lot # J015378, expiration date 09-APR-2016, dose and frequency not reported). On an unknown date (also reported as reported as immediately) the patient developed fever, nausea, dizziness, stiff back, stiff neck and muscle pains. It was stated that the injection site had swelling and erythema. All events worsened by day three post injection and resolved by day 7 post injection (07-JAN-2015). The patient sought medical attention and contacted the office. The relatedness between the events and GARDASIL was not reported. Additional information has been requested.
Age: 75.0
Sex: U
Vaccine: VARZOS
Symptoms: Extra dose administered, No adverse event
Clinical narrative: Information has been received from a pharmacist concerning a 75 year old patient of unknown gender who received two doses of ZOSTAVAX (strength, dose, route, lot# and expiration date were not reported) in error. The first dose of ZOSTAVAX was received on 17-DEC-2011, and the second dose was received on 24-JAN-2015 (extra dose administered). The patient had not reported an adverse experience. It was unspecified if the patient sought medical attention. Additional information has been requested.
Sex: U
Vaccine: MMR
Symptoms: Expired product administered, No adverse event
Clinical narrative: Information has been received from a healthcare worker (Certified Medical Assistant) referring to a patient of unknown age. On 06-FEB-2015, the patient was inadvertently administered an expired dose of M-M-R II injection which had expired on 19-JAN-2015, 0.5 ml (unspecified dose series), subcutaneously. No adverse effect reported. No product quality complaint was involved. Additional information has been requested.
Sex: U
Vaccine: MMR
Symptoms: Vaccination complication
Clinical narrative: This spontaneous report as received from a nurse refers to a patient of unknown age and gender. Pertinent medical history was unknown. The reporter stated that on an unknown date the patient was affected with MMR II (dose, route of administration and anatomical location was unknown). Concomitant medications were unspecified by reporter. Action taken with MMR II was not reported. The outcome of the event was unknown. The causal relationship between the event and MMR II was not reported. No further information was provided. Additional information has been requested.