chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 68.0
Sex: M
Vaccine: FLU3
Symptoms: Pain, Pain in extremity
Clinical narrative: Case number PHHY2014US055890, is an initial spontaneous report received from the Vaccine Adverse Event Reporting System (VAERS reference number: 524432) website on 06 MAY 2014. This report refers to a 68-year-old male patient. Concomitant drugs included Atorvastatin and Lisinopril hydrochlorothiazide. He was vaccinated with FLUVIRIN 2013/2014 (batch number: 13424P) intramuscularly in the left arm on 25 SEP 2013. On the same day after vaccination he experienced pain in his left arm and it was painful wen lifting it up. The event continued till 27 FEB 2014 and final outcome of the event was not reported. The seriousness and causality of the event was not reported.
Age: 53.0
Sex: F
Vaccine: FLU3, PPV
Symptoms: Arthralgia, Rash erythematous, Rash generalised
Clinical narrative: Case number PHHY2014US054791 is an initial spontaneous report received from a consumer via Vaccine Adverse Event Reporting System (VAERS reference number: 524501) website on 06 MAY 2014. This report refers to a 53-year old female patient. Concomitant medications included unspecified high blood pressure and pain medications. She was vaccinated with FLUVIRIN 2013/2014 (batch number: unknown) on 16 DEC 2013. On the same day, she was also vaccinated with Pneumovax (other manufacturer and batch number: unknown). On 30 DEC 2013, 14 days after vaccinations, she developed rash in red spots on chest area and on body. On an unknown date in JAN 2014, she experienced pain in wrist area both wrist and elbow area. She went to the doctor on or about 03 JAN 2014 who had put her on cream and methylprednisolone. On 01 FEB 2014, rash developed on stomach area, arm and continued over body. She was due to see her doctor and continued  on cream as prescribed. These events were reported as non-serious. Outcome of the events was reported as condition unchanged as of 04 MAR 2014. Causality of the events was not reported.
Age: 40.0
Sex: F
Vaccine: FLU3
Symptoms: Arthralgia, Injection site pain, Pain in extremity
Clinical narrative: Case number PHHY2014US5907, is an initial spontaneous report received from the Vaccine Adverse Event Reporting System (VAERS reference number: 525021) website on 06 MAY 2014. This report refers to a 40-year-old female patient. She was vaccinated with FLUVIRIN 2013/2014 (batch number: 201314) intramuscularly in the left arm on 06 NOV 2013. On 12 DEC 2013, the patient experienced constant aching pain in injection site that spread down to fingers and up through shoulder. She had aches like arthritis all the time which never lets up. The patient visited the emergency room. It was reported that the doctors have no idea about the events but all the symptoms matches the symptoms of SIRVA (not confirmed). The final outcome of the events reported as not recovered. The seriousness and causality of the events were not reported.
Age: 0.38
Sex: F
Vaccine: DTAP
Symptoms: Cyanosis, Dyspnoea, Eye swelling, Injection site swelling, Ocular hyperaemia
Clinical narrative: Whole Left side of her Face swelling / eye swelling and bright red. Fever. Screaming until turning blue. Difficulty breathing. Swelling where needle was inserted.
Age: 0.38
Sex: F
Vaccine: DTAP
Symptoms: Pyrexia, Screaming, Swelling face
Clinical narrative: Whole Left side of her Face swelling / eye swelling and bright red. Fever. Screaming until turning blue. Difficulty breathing. Swelling where needle was inserted.
Age: 55.0
Sex: M
Vaccine: FLUX
Symptoms: Anaemia, Blood iron decreased, Haemoglobin decreased, Malaise, Transfusion
Clinical narrative: Case number PHHY2015US004723, is an initial spontaneous report received from the Vaccine Adverse Event Reporting System (VAERS reference number: 548364) website on 06 Jan 2015. This report refers to a 55 year old male patient. Medical history was not reported. Concomitant medication included valsartan with hydrochlorothiazide, KLOR-CON, AMBIEN PRN, PROVIGIL PRN, CIALIS PRN, clonidine PRN for systolic pressure of greater than 170. On 02 Oct 2014 at 8:00pm, he was vaccinated with seasonal influenza vaccine (manufacturer and batch number: unknown). He became very sick at 03:00 am the next morning, on 03 Oct 2014. The patient went to the emergency room and his blood work was normal. Six days later he was very ill and went to the ER and haemoglobin was 8.4 down the week before from 16.2. He was hospitalized for 5 days. Lab data reported anemia and low iron. He received two units of blood for acute anemia. Final outcome of the events was unknown. Causality assessment was not reported. Event was reported as serious (hospitalization).
Age: 40.0
Sex: F
Vaccine: FLUX
Symptoms: Carotid sinus massage, Chest discomfort, Disorientation, Dizziness, Dyspnoea
Clinical narrative: Case number PHHY2015US004726, is an initial spontaneous report received from the Vaccine Adverse Event Reporting System (VAERS reference number: 548411) website on 06 Jan 2015. This report refers to a 40 year old female patient. Current conditions included asthma, mitral valve; tricuspid; aortic regurgitation, mitral valve prolapse, BOTOX injections for laryngeal spasms and seizures. She was allergic to: DARVOCET, intravenous pyelogram (IVP) dye, GASTROGAFIN (oral contrast), fish, shellfish, lima beans, melons, nuts, ULTRAM and doxycycline. Concomitant medication included DILAUDID 8mg, PHENERGAN 25mg, fentanyl 50 mcg patch, VALIUM 10mg, multivitamin, PERI-COLACE, KEPPRA, LAMICTAL, levalbuterol nebulizer. On 16 Oct 2014, she was vaccinated with seasonal influenza vaccine (manufacturer and batch number: unknown) intramuscular into right arm. On the same day post vaccination she developed tachycardia (112-120 bpm), palpitations, shortness of breath, feeling faint and slightly disoriented. The patient (nurse) performed carotid massage and heart rate slowed to upper nineties. She had to repeat frequently throughout the night. The patient did not have the funds to go to the emergency room, the feeling of pressure and palpitations went away after approximately two hours after carotid massage (performed on and off), the feeling of fainting stopped as well. She left with a feeling ill; feeling off and just not feeling good. The patient had multiple flu vaccines (manufacturer and batch number: unknown) and pneumonia vaccines (manufacturer and batch number: unknown) with none of the symptoms listed above before. Final outcome of the events was not reported. Causality assessment was not reported. Event was reported as non-serious. Seriousness assessment of shortness of breath was upgraded based on information available in the source documents.
Age: 40.0
Sex: F
Vaccine: FLUX
Symptoms: Feeling abnormal, Heart rate increased, Malaise, Palpitations, Tachycardia
Clinical narrative: Case number PHHY2015US004726, is an initial spontaneous report received from the Vaccine Adverse Event Reporting System (VAERS reference number: 548411) website on 06 Jan 2015. This report refers to a 40 year old female patient. Current conditions included asthma, mitral valve; tricuspid; aortic regurgitation, mitral valve prolapse, BOTOX injections for laryngeal spasms and seizures. She was allergic to: DARVOCET, intravenous pyelogram (IVP) dye, GASTROGAFIN (oral contrast), fish, shellfish, lima beans, melons, nuts, ULTRAM and doxycycline. Concomitant medication included DILAUDID 8mg, PHENERGAN 25mg, fentanyl 50 mcg patch, VALIUM 10mg, multivitamin, PERI-COLACE, KEPPRA, LAMICTAL, levalbuterol nebulizer. On 16 Oct 2014, she was vaccinated with seasonal influenza vaccine (manufacturer and batch number: unknown) intramuscular into right arm. On the same day post vaccination she developed tachycardia (112-120 bpm), palpitations, shortness of breath, feeling faint and slightly disoriented. The patient (nurse) performed carotid massage and heart rate slowed to upper nineties. She had to repeat frequently throughout the night. The patient did not have the funds to go to the emergency room, the feeling of pressure and palpitations went away after approximately two hours after carotid massage (performed on and off), the feeling of fainting stopped as well. She left with a feeling ill; feeling off and just not feeling good. The patient had multiple flu vaccines (manufacturer and batch number: unknown) and pneumonia vaccines (manufacturer and batch number: unknown) with none of the symptoms listed above before. Final outcome of the events was not reported. Causality assessment was not reported. Event was reported as non-serious. Seriousness assessment of shortness of breath was upgraded based on information available in the source documents.
Age: 33.0
Sex: F
Vaccine: FLUX
Symptoms: Herpes zoster, Hyperaesthesia, Rash
Clinical narrative: Case number PHHY2015US004725, is an initial spontaneous report received from the Vaccine Adverse Event Reporting System (VAERS reference number: 550956) website on 06 Jan 2015. This report refers to a 33 year old female patient. Medical history and concomitant medication was not reported. On 15 Oct 2014, she was vaccinated with seasonal influenza vaccine (manufacturer and batch number: unknown) intramuscular into left arm. On 21 Oct 2014, she developed sensitivity on the left side just below breast to the bottom of rib cage. On 24 Oct 2014, rash began to develop only in the area of sensitivity. She called the doctor and began valacyclovir for shingles on 25 Oct 2014. Symptoms persist at time of this report. Final outcome of the events was unknown as of 29 Oct 2014. Causality assessment was not reported. Event was reported as non-serious. Seriousness assessment of shingles was upgraded based on information available in the source documents.
Age: 69.0
Sex: M
Vaccine: VARZOS
Symptoms: Erythema, Herpes zoster, Rash erythematous
Clinical narrative: Information was received from a 69 year old male patient with chronic obstructive pulmonary disease (COPD) and no history of drug reactions/allergies. On 31-OCT-2014, the patient was vaccinated at a pharmacy with ZOSTAVAX in the right arm (dosage and route of administration not provided). Concomitant therapies included simvastatin (manufacturer unknown). Two hours later, the patient returned to the pharmacy with a red rash and was diagnosed with "shingles." The patient reported that the redness and swelling extended from his shoulders to elbow over the next few days. The patient then visited his doctor's office on an unknown date where the diagnosis was confirmed, and he was prescribed ZOVIRAX 800 mg, 5 tablets daily, and NEURONTIN 300 mg, 3 times daily. The patient stated it took 21 days to recover. No further information provided. Additional information has been requested.
Sex: U
Vaccine: VARZOS
Symptoms: Expired product administered, No adverse event
Clinical narrative: This spontaneous report as received from a pharmacist refers to a patient of unknown age and gender. No medical history or concurrent conditions reported. On 21-DEC-2014 the patient was vaccinated with an expired dose of ZOSTAVAX (route, dose number and strength were not provided) (lot # H012523 expiration date 09-OCT-2013). Concomitant therapy was not provided. No adverse effects reported. Additional information is not expected since no permission to contact was given.
Age: 24.0
Sex: M
Vaccine: TYP
Symptoms: Headache, Lymphadenopathy, Malaise, Muscular weakness, Pain
Clinical narrative: Right arm weakness, soreness, headache, generalized body aches and malaise, noted to have bilateral swollen submandibular lymph nodes dime-sized.
Age: 34.0
Sex: M
Vaccine: TYP
Symptoms: Asthenopia, Fatigue, Headache, Vision blurred
Clinical narrative: Headache, increased fatigue, by the next morning was experiencing increased eye fatigue resulting in blurred vision. VA on exam today was 20/20 OD OS OU. PE unremarkable.
Age: 0.3
Sex: U
Vaccine: RV5
Symptoms: Dehydration, Diarrhoea, Incomplete course of vaccination, Malaise
Clinical narrative: This spontaneous report was received from a physician via a company representative and refers to the physician's 4 month-old grandchild of unknown gender. The patient's concurrent condition included unspecified malabsorption issues. The physician reported that on an unknown date her 4 month-old grandchild was vaccinated with a second dose of ROTATEQ orally (dose unspecified) and became very ill (date unspecified). Within 10 days, the infant experienced diarrhoea and dehydration and as, a result, the infant was hospitalized for an unspecified period of time on unspecified dates. It was reported that since the infant was hospitalized and received unspecified treatments for the dehydration, the infant may have had a life-threatening condition. It was not reported which of the laboratory tests or diagnostic studies were performed. The physician informed that the infant would not receive the third dose of ROTATEQ due to these adverse experiences. The outcomes of the events were reported as recovered/resolved (date unspecified). The relatedness between the events and ROTATEQ was not reported. Additional information has been requested.
Age: 60.0
Sex: F
Vaccine: VARZOS
Symptoms: Blood folate increased, Chest X-ray abnormal, Computerised tomogram thorax abnormal, Facial pain, Formication
Clinical narrative: This spontaneous report as received from a nurse practitioner refers to a 60 year old female patient. Concurrent condition included Attention deficit/hyperactivity disorder (ADHD), allergic rhinitis, hypothyroidism, hepatitis C and intolerance to TYLENOL with nausea, vomiting and diarrhea. The patient's medical history included glaucoma. On 20-JUN-2014 the patient was vaccinated with a dose of ZOSTAVAX, (lot number not specified) through an unspecified route. Concomitant therapies included FLONASE, SYNTHROID, EXCEDRIN MIGRAINE, ADDERALL Tablets, loratadine (manufacturer unknown), PERCOCET and VENTOLIN Inhaler. On an unknown date in 2014 (2 to 6 weeks after injection) the patient developed creepy crawlies in her left cheek with headaches, this was further described by nurse practitioner as similar to neuralgia in left cheek or prodromal symptoms of Zoster. The nurse practitioner stated that patient never developed rash. The patient told nurse that she had left cheek numbness and sharp stabbing pain in entire left side of head. On an unknown date in November 2014 the patient was treated with oral AUGMENTIN for sinus infection. On an unknown date in December 2014, the patient was diagnosed with pneumonia after chest x-ray and chest computerised axial tomography (CAT) scan. Additional treatment included LEVAQUIN, tapering steroids, NEURONTIN, oxycodone, coconut oil swish, spit and INDOCIN. All treatments were not effective to left cheek event. The patient sought medical attention on 08-JAN-2015 where she had a normal cranial nerve assessment. On 08-JAN-2015 the patient had high sensitivity at left cheek with swelling with streak of pain from left bridge of nose to left ear which was pallor color. The patient's lab studies included CBC, Chem 7 and ESR were with normal range but the folate level was high. The nurse practitioner stated that patient's current diagnosis was a condition known as ice pick headache, idiopathic stabbing headache, or jabbing and jolting headache (disability). The outcome of the events was reported as not recovered. The reporter did not assess the causality for the events. The patient was referred to neurology and MRI of head is scheduled. The event ice pick headache, idiopathic stabbing headache, or jabbing and jolting headache was considered serious due to serious criteria of disability. Additional information has been requested.
Age: 60.0
Sex: F
Vaccine: VARZOS
Symptoms: Full blood count normal, Headache, Hypoaesthesia, Laboratory test normal, Pallor
Clinical narrative: This spontaneous report as received from a nurse practitioner refers to a 60 year old female patient. Concurrent condition included Attention deficit/hyperactivity disorder (ADHD), allergic rhinitis, hypothyroidism, hepatitis C and intolerance to TYLENOL with nausea, vomiting and diarrhea. The patient's medical history included glaucoma. On 20-JUN-2014 the patient was vaccinated with a dose of ZOSTAVAX, (lot number not specified) through an unspecified route. Concomitant therapies included FLONASE, SYNTHROID, EXCEDRIN MIGRAINE, ADDERALL Tablets, loratadine (manufacturer unknown), PERCOCET and VENTOLIN Inhaler. On an unknown date in 2014 (2 to 6 weeks after injection) the patient developed creepy crawlies in her left cheek with headaches, this was further described by nurse practitioner as similar to neuralgia in left cheek or prodromal symptoms of Zoster. The nurse practitioner stated that patient never developed rash. The patient told nurse that she had left cheek numbness and sharp stabbing pain in entire left side of head. On an unknown date in November 2014 the patient was treated with oral AUGMENTIN for sinus infection. On an unknown date in December 2014, the patient was diagnosed with pneumonia after chest x-ray and chest computerised axial tomography (CAT) scan. Additional treatment included LEVAQUIN, tapering steroids, NEURONTIN, oxycodone, coconut oil swish, spit and INDOCIN. All treatments were not effective to left cheek event. The patient sought medical attention on 08-JAN-2015 where she had a normal cranial nerve assessment. On 08-JAN-2015 the patient had high sensitivity at left cheek with swelling with streak of pain from left bridge of nose to left ear which was pallor color. The patient's lab studies included CBC, Chem 7 and ESR were with normal range but the folate level was high. The nurse practitioner stated that patient's current diagnosis was a condition known as ice pick headache, idiopathic stabbing headache, or jabbing and jolting headache (disability). The outcome of the events was reported as not recovered. The reporter did not assess the causality for the events. The patient was referred to neurology and MRI of head is scheduled. The event ice pick headache, idiopathic stabbing headache, or jabbing and jolting headache was considered serious due to serious criteria of disability. Additional information has been requested.
Age: 60.0
Sex: F
Vaccine: VARZOS
Symptoms: Pneumonia, Red blood cell sedimentation rate normal, Sinusitis, Swelling face
Clinical narrative: This spontaneous report as received from a nurse practitioner refers to a 60 year old female patient. Concurrent condition included Attention deficit/hyperactivity disorder (ADHD), allergic rhinitis, hypothyroidism, hepatitis C and intolerance to TYLENOL with nausea, vomiting and diarrhea. The patient's medical history included glaucoma. On 20-JUN-2014 the patient was vaccinated with a dose of ZOSTAVAX, (lot number not specified) through an unspecified route. Concomitant therapies included FLONASE, SYNTHROID, EXCEDRIN MIGRAINE, ADDERALL Tablets, loratadine (manufacturer unknown), PERCOCET and VENTOLIN Inhaler. On an unknown date in 2014 (2 to 6 weeks after injection) the patient developed creepy crawlies in her left cheek with headaches, this was further described by nurse practitioner as similar to neuralgia in left cheek or prodromal symptoms of Zoster. The nurse practitioner stated that patient never developed rash. The patient told nurse that she had left cheek numbness and sharp stabbing pain in entire left side of head. On an unknown date in November 2014 the patient was treated with oral AUGMENTIN for sinus infection. On an unknown date in December 2014, the patient was diagnosed with pneumonia after chest x-ray and chest computerised axial tomography (CAT) scan. Additional treatment included LEVAQUIN, tapering steroids, NEURONTIN, oxycodone, coconut oil swish, spit and INDOCIN. All treatments were not effective to left cheek event. The patient sought medical attention on 08-JAN-2015 where she had a normal cranial nerve assessment. On 08-JAN-2015 the patient had high sensitivity at left cheek with swelling with streak of pain from left bridge of nose to left ear which was pallor color. The patient's lab studies included CBC, Chem 7 and ESR were with normal range but the folate level was high. The nurse practitioner stated that patient's current diagnosis was a condition known as ice pick headache, idiopathic stabbing headache, or jabbing and jolting headache (disability). The outcome of the events was reported as not recovered. The reporter did not assess the causality for the events. The patient was referred to neurology and MRI of head is scheduled. The event ice pick headache, idiopathic stabbing headache, or jabbing and jolting headache was considered serious due to serious criteria of disability. Additional information has been requested.
Sex: F
Vaccine: HPV4
Symptoms: Cervix carcinoma
Clinical narrative: This spontaneous report as received from a nurse (who is also the patient, her age was reported as "early 20's") via company representative. In approximately 2011 (reported as "about 4 years ago") the patient was vaccinated with the first dose of GARDASIL (dosage schedule and route of administration were not provided). The patient completed the series of vaccinations on an unknown date in approximately 2012 (reported as "about 3 years ago"). In approximately 2012 (reported as "about 3 years ago") the patient was diagnosed with cervical cancer after getting GARDASIL (the patient mentioned that she was diagnosed with cervical cancer approximately a year after she had completed the series of shots). The patient explained it was almost an exact year from the time she initially received her first dose of GARDASIL. It was explained that she received the full 3 shots when she was 18. On her 19th birthday, she was diagnosed with cervical cancer. The outcome of cervical cancer was unknown. Patient sought medical attention. The relatedness between cervical cancer and vaccination with GARDASIL was not reported. Upon internal review cervical cancer was considered to be medically significant. Additional information has been requested.
Age: 2.0
Sex: F
Vaccine: HEP, IPV
Symptoms: Constipation
Clinical narrative: Constipation.
Age: 46.0
Sex: F
Vaccine: FLUX
Symptoms: Injection site pain, Joint range of motion decreased, Pain, Sleep disorder
Clinical narrative: Sore arm where injection was given, limited range of motion, shooting pain, unable to sleep on left arm.
Age: 60.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site discomfort, Injection site erythema, Injection site induration, Injection site pain, Injection site pruritus
Clinical narrative: Patient approached me and said the Zostavax vaccine was given in her upper left posterior arm on Friday, 1/9/15.  She said approximately 36 hours after (very early Sunday morning) the injection the site was warm, very red, itchy and somewhat painful.  There was an area of swelling/induration and redness  2 inches by 4 inches at the injection site.  Around this area the skin was slightly pink.  It was a raised rash.  Uncomfortable rash but painful to touch.  Only used comfort measures  warm compresses and a oatmeal based lotion which helped relieve itching. Wednesday (14th), rash is pink, flat, with some itchiness. Today (16th) itching is gone, hint of pink to the injection area approximately 2" in diameter.
Age: 60.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site rash, Injection site swelling, Injection site warmth
Clinical narrative: Patient approached me and said the Zostavax vaccine was given in her upper left posterior arm on Friday, 1/9/15.  She said approximately 36 hours after (very early Sunday morning) the injection the site was warm, very red, itchy and somewhat painful.  There was an area of swelling/induration and redness  2 inches by 4 inches at the injection site.  Around this area the skin was slightly pink.  It was a raised rash.  Uncomfortable rash but painful to touch.  Only used comfort measures  warm compresses and a oatmeal based lotion which helped relieve itching. Wednesday (14th), rash is pink, flat, with some itchiness. Today (16th) itching is gone, hint of pink to the injection area approximately 2" in diameter.
Age: 33.0
Sex: M
Vaccine: TDAP
Symptoms: Abdominal pain upper, Fatigue, Headache
Clinical narrative: Feeling tired, headache several hours after injection and stomach ache several hours after injection lasting until 10:00 AM following day. Took aspirin for headache.
Age: 27.0
Sex: F
Vaccine: PPV
Symptoms: Full blood count, Injection site erythema, Injection site pain, Musculoskeletal stiffness, Neck pain
Clinical narrative: Fever 101, Redness to Area, Stiffness of right arm, pain in shoulder and neck.
Age: 27.0
Sex: F
Vaccine: PPV
Symptoms: Pyrexia
Clinical narrative: Fever 101, Redness to Area, Stiffness of right arm, pain in shoulder and neck.
Age: 54.0
Sex: F
Vaccine: HEP
Symptoms: Dizziness, Dyspnoea, Nasopharyngitis, Pyrexia
Clinical narrative: Client stated that she had cold symptoms, fever, dizziness and shortness of breath. She treated the fever at home and rested. Client did not seek medical help.
Age: 1.02
Sex: F
Vaccine: MMR, VARCEL
Symptoms: Injection site reaction, Pruritus, Pyrexia, Rash vesicular, Skin lesion
Clinical narrative: Vesicular bumps were noticed at the injection site of the varicella vaccine. There were two lesions noted. They did seem to itch the baby a bit. Fever began that evening-101.5F  Reassured that this is likely a moderate vaccine reaction. Baby seemed happy and comfortable. Verified that parents have had chickenpox or the vaccine. Asked to f/u if it worsens. Ok to use Children's Benadryl for itching if needed. F/u if fever lasts more than 3 days or with concerns.
Age: 1.02
Sex: F
Vaccine: MMR, VARCEL
Symptoms: Vaccination complication
Clinical narrative: Vesicular bumps were noticed at the injection site of the varicella vaccine. There were two lesions noted. They did seem to itch the baby a bit. Fever began that evening-101.5F  Reassured that this is likely a moderate vaccine reaction. Baby seemed happy and comfortable. Verified that parents have had chickenpox or the vaccine. Asked to f/u if it worsens. Ok to use Children's Benadryl for itching if needed. F/u if fever lasts more than 3 days or with concerns.
Age: 44.0
Sex: F
Vaccine: FLU3
Symptoms: Ataxia, Autonomic neuropathy, Balance disorder, Burning sensation, CSF oligoclonal band present
Clinical narrative: Over several weeks, had intermittent symptoms of burning and numbness in legs. Change in vision (spots) once. Difficulty swallowing several times. Sudden onset (12/17/14) difficulty walking, loss of balance, cognitive function, orthostatic hypertension requiring trip to ER. Received IV steroids 1000mg x3 days after approx.  One week in hospital and po until 1/9/14. Given for ataxia, significant clonus reflex, hypereflexia, labile autonomic nervous response, myelopothy. Also placed on Toprol XL 12.5mg daily.
Age: 44.0
Sex: F
Vaccine: FLU3
Symptoms: CSF protein normal, Clonus, Cognitive disorder, Dysphagia, Gait disturbance
Clinical narrative: Over several weeks, had intermittent symptoms of burning and numbness in legs. Change in vision (spots) once. Difficulty swallowing several times. Sudden onset (12/17/14) difficulty walking, loss of balance, cognitive function, orthostatic hypertension requiring trip to ER. Received IV steroids 1000mg x3 days after approx.  One week in hospital and po until 1/9/14. Given for ataxia, significant clonus reflex, hypereflexia, labile autonomic nervous response, myelopothy. Also placed on Toprol XL 12.5mg daily.
Age: 44.0
Sex: F
Vaccine: FLU3
Symptoms: Hyperreflexia, Hypoaesthesia, Myelopathy, Orthostatic hypertension, Visual impairment
Clinical narrative: Over several weeks, had intermittent symptoms of burning and numbness in legs. Change in vision (spots) once. Difficulty swallowing several times. Sudden onset (12/17/14) difficulty walking, loss of balance, cognitive function, orthostatic hypertension requiring trip to ER. Received IV steroids 1000mg x3 days after approx.  One week in hospital and po until 1/9/14. Given for ataxia, significant clonus reflex, hypereflexia, labile autonomic nervous response, myelopothy. Also placed on Toprol XL 12.5mg daily.
Age: 37.0
Sex: F
Vaccine: FLU3, PPV
Symptoms: Injection site pain, Injection site swelling
Clinical narrative: Severe pain and generalized swelling in right upper arm.  No redness or localized swelling.  Patient noticed this pain 24 hours injection of Fluzone and Pnu-Immune vaccines in right upper arm.
Age: 66.0
Sex: M
Vaccine: PNC13
Symptoms: Arthralgia, Body temperature increased, Cough, Headache, Injection site pain
Clinical narrative: PER PT, RECEIVED PREVNAR 13 ON 1/14/15. WOKE UP 1/15/15 WITH MODERATE LEFT DELTOID PAIN (LIKE HE GOT PUNCHED IN ARM), GENERALIZED MUSCLE & JOINT ACHES WORSE IN LEFT ARM. TEMP = 99.7. + COUGH AND HEADACHE, 4 X 2 INCH SWELLING AT INJECTION SITE. ALL SYMPTOMS IMPROVED TODAY BY ABOUT 80% EXCEPT INJECTION SITE SWELLING.
Age: 66.0
Sex: M
Vaccine: PNC13
Symptoms: Injection site swelling, Myalgia
Clinical narrative: PER PT, RECEIVED PREVNAR 13 ON 1/14/15. WOKE UP 1/15/15 WITH MODERATE LEFT DELTOID PAIN (LIKE HE GOT PUNCHED IN ARM), GENERALIZED MUSCLE & JOINT ACHES WORSE IN LEFT ARM. TEMP = 99.7. + COUGH AND HEADACHE, 4 X 2 INCH SWELLING AT INJECTION SITE. ALL SYMPTOMS IMPROVED TODAY BY ABOUT 80% EXCEPT INJECTION SITE SWELLING.
Age: 69.0
Sex: F
Vaccine: FLU3
Symptoms: Dyspnoea, Injection site swelling
Clinical narrative: Swelling at injection site, difficulty breathing.
Age: 35.0
Sex: F
Vaccine: HEPAB, HEP, HEPA
Symptoms: Hypersensitivity, Paraesthesia, Pharyngeal oedema
Clinical narrative: This case was reported by a nurse via call center representative and described the occurrence of allergic reaction in a 36-year-old female patient who received TWINRIX adult. Concomitant products included contraceptive nos and amitriptyline. On 12th January 2015, the patient received the 1st dose of TWINRIX adult. On 12th January 2015, an unknown time after receiving TWINRIX adult, the patient experienced allergic reaction (serious criteria hospitalization, disability, life threatening and clinically significant/intervention required), throat swelling (serious criteria hospitalization, disability, life threatening, clinically significant/intervention required and other) and tingling (serious criteria hospitalization, disability, life threatening and clinically significant/intervention required). The patient was treated with BENADRYL and SOLU-MEDROL. On 13th January 2015, the outcome of the allergic reaction and tingling were not recovered/not resolved and the outcome of the throat swelling was recovered/resolved. The reporter considered the allergic reaction, throat swelling and tingling to be almost certainly related to TWINRIX adult. Additional details provided: The patient received TWINRIX adult at her doctor's office yesterday as 2 shots in 2 separate arms (for unknown reason) and began having allergic reaction described as throat swelling and tingling all over the body. The patient took BENADRYL at home without effect and came to emergency room 4 hours after the dose was administered. The outcome of the events did not worsen to a life threatening/disabling condition since she was smart to take BENADRYL and go to emergency room. Her symptoms especially the tingling was still continuing. The patient was kept in the observation in hospital at least 1 day. The patient was not sure if she took other medications. The reporter was questioning if the patient really received TWINRIX or single antigen hepatitis A and B vaccines.
Age: 35.0
Sex: F
Vaccine: HEPAB, HEP, HEPA
Symptoms: Blood pressure increased, Dizziness, Dyspnoea, Headache, Heart rate increased
Clinical narrative: This case was reported by a nurse via call center representative and described the occurrence of allergic reaction in a 36-year-old female patient who received TWINRIX adult. Concomitant products included contraceptive nos and amitriptyline. On 12th January 2015, the patient received the 1st dose of TWINRIX adult. On 12th January 2015, an unknown time after receiving TWINRIX adult, the patient experienced allergic reaction (serious criteria hospitalization, disability, life threatening and clinically significant/intervention required), throat swelling (serious criteria hospitalization, disability, life threatening, clinically significant/intervention required and other) and tingling (serious criteria hospitalization, disability, life threatening and clinically significant/intervention required). The patient was treated with BENADRYL and SOLU-MEDROL. On 13th January 2015, the outcome of the allergic reaction and tingling were not recovered/not resolved and the outcome of the throat swelling was recovered/resolved. The reporter considered the allergic reaction, throat swelling and tingling to be almost certainly related to TWINRIX adult. Additional details provided: The patient received TWINRIX adult at her doctor's office yesterday as 2 shots in 2 separate arms (for unknown reason) and began having allergic reaction described as throat swelling and tingling all over the body. The patient took BENADRYL at home without effect and came to emergency room 4 hours after the dose was administered. The outcome of the events did not worsen to a life threatening/disabling condition since she was smart to take BENADRYL and go to emergency room. Her symptoms especially the tingling was still continuing. The patient was kept in the observation in hospital at least 1 day. The patient was not sure if she took other medications. The reporter was questioning if the patient really received TWINRIX or single antigen hepatitis A and B vaccines.
Age: 35.0
Sex: F
Vaccine: HEPAB, HEP, HEPA
Symptoms: Hypoaesthesia, Oropharyngeal pain, Paraesthesia, Pharyngeal hypoaesthesia, Throat tightness
Clinical narrative: This case was reported by a nurse via call center representative and described the occurrence of allergic reaction in a 36-year-old female patient who received TWINRIX adult. Concomitant products included contraceptive nos and amitriptyline. On 12th January 2015, the patient received the 1st dose of TWINRIX adult. On 12th January 2015, an unknown time after receiving TWINRIX adult, the patient experienced allergic reaction (serious criteria hospitalization, disability, life threatening and clinically significant/intervention required), throat swelling (serious criteria hospitalization, disability, life threatening, clinically significant/intervention required and other) and tingling (serious criteria hospitalization, disability, life threatening and clinically significant/intervention required). The patient was treated with BENADRYL and SOLU-MEDROL. On 13th January 2015, the outcome of the allergic reaction and tingling were not recovered/not resolved and the outcome of the throat swelling was recovered/resolved. The reporter considered the allergic reaction, throat swelling and tingling to be almost certainly related to TWINRIX adult. Additional details provided: The patient received TWINRIX adult at her doctor's office yesterday as 2 shots in 2 separate arms (for unknown reason) and began having allergic reaction described as throat swelling and tingling all over the body. The patient took BENADRYL at home without effect and came to emergency room 4 hours after the dose was administered. The outcome of the events did not worsen to a life threatening/disabling condition since she was smart to take BENADRYL and go to emergency room. Her symptoms especially the tingling was still continuing. The patient was kept in the observation in hospital at least 1 day. The patient was not sure if she took other medications. The reporter was questioning if the patient really received TWINRIX or single antigen hepatitis A and B vaccines.
Age: 35.0
Sex: F
Vaccine: HEPAB, HEP, HEPA
Symptoms: Urticaria, Visual impairment
Clinical narrative: This case was reported by a nurse via call center representative and described the occurrence of allergic reaction in a 36-year-old female patient who received TWINRIX adult. Concomitant products included contraceptive nos and amitriptyline. On 12th January 2015, the patient received the 1st dose of TWINRIX adult. On 12th January 2015, an unknown time after receiving TWINRIX adult, the patient experienced allergic reaction (serious criteria hospitalization, disability, life threatening and clinically significant/intervention required), throat swelling (serious criteria hospitalization, disability, life threatening, clinically significant/intervention required and other) and tingling (serious criteria hospitalization, disability, life threatening and clinically significant/intervention required). The patient was treated with BENADRYL and SOLU-MEDROL. On 13th January 2015, the outcome of the allergic reaction and tingling were not recovered/not resolved and the outcome of the throat swelling was recovered/resolved. The reporter considered the allergic reaction, throat swelling and tingling to be almost certainly related to TWINRIX adult. Additional details provided: The patient received TWINRIX adult at her doctor's office yesterday as 2 shots in 2 separate arms (for unknown reason) and began having allergic reaction described as throat swelling and tingling all over the body. The patient took BENADRYL at home without effect and came to emergency room 4 hours after the dose was administered. The outcome of the events did not worsen to a life threatening/disabling condition since she was smart to take BENADRYL and go to emergency room. Her symptoms especially the tingling was still continuing. The patient was kept in the observation in hospital at least 1 day. The patient was not sure if she took other medications. The reporter was questioning if the patient really received TWINRIX or single antigen hepatitis A and B vaccines.
Sex: F
Vaccine: FLUX
Symptoms: Exposure during pregnancy, Injection site cellulitis
Clinical narrative: This is a prospective pregnancy case. This female subject was enrolled in a study. The subject received Flu Seasonal QIV (other) .5 ml on 23rd September 2014. On an unknown date, an unknown time after receiving Flu Seasonal QIV the subject developed injection site cellulitis. Serious criteria included GSK medically significant. Additional event(s) included vaccine exposure during pregnancy. The subject was treated with antibiotics nos (Unknown Antibiotic). The outcome of injection site cellulitis was unknown. The outcome(s) of the additional event(s) included vaccine exposure during pregnancy (unknown). The pregnancy was ongoing. It was unknown if the investigator considered the injection site cellulitis to be related to Flu Seasonal QIV. Additional details provided: It was unknown if the patient had concomitant medication, medical history, past drug therapy or any adverse events following previous vaccinations. It was not precisely known if patient was pregnant, but the field representative noted it may be a possibility. The patient developed cellulitis at the injection site and was seen by the nurse practitioner. The patient was placed on an unknown antibiotic and compresses were applied to the site.
Age: 63.0
Sex: F
Vaccine: FLU3, FLU3
Symptoms: Joint range of motion decreased, Periarthritis
Clinical narrative: Frozen shoulder in the receptive arm, ROM limited above and below shoulder beginning a few days after vaccine. Now in PT.
Age: 63.0
Sex: M
Vaccine: FLU3
Symptoms: Hemiplegia, Malaise, Muscle spasms, Myelitis transverse
Clinical narrative: Now right side paralysis. Events started as spasms in back, shoulder and neck both arms. Hospitalization and pt also sick at home for at 2 wks right after vaccine.
Age: 47.0
Sex: F
Vaccine: YF
Symptoms: Injection site erythema, Injection site pruritus, Injection site swelling
Clinical narrative: Redness at injection site, Swelling @ injection site, itching @ injection site.
Age: 11.0
Sex: M
Vaccine: HEP, HEPA, IPV, MMR, TDAP, VARCEL
Symptoms: Erythema, Peripheral swelling, Skin warm, Tenderness
Clinical narrative: Patient reported vaccine reaction to school staff on 1/16/2015 at 9:12am.  Staff reports 2/3 of left arm warm, swollen, tender, red approximately 5 in x 2.5 in.  Mom states no fever or any other symptoms.  Referred to Dr., appointment today at 11 am.
Age: 4.0
Sex: M
Vaccine: DTAPIPV
Symptoms: Injection site erythema, Injection site pain, Injection site pruritus, Peripheral swelling
Clinical narrative: Father reports onset 1 day ago of left thigh swelling, erythema, pain, and itching at the injection site.  States it is getting worse.
Age: 41.0
Sex: F
Vaccine: FLU3, FLUX
Symptoms: Activities of daily living impaired, Drug administered at inappropriate site, Injected limb mobility decreased, Injection site bruising, Insomnia
Clinical narrative: I went to Pharmacy the morning of 12/1/14 for a routine flu vaccine.  The vaccine was administered high into my left shoulder.  I did not think much of it at the time, but by early afternoon I began to experience pain and I was barely able to move my arm.  I receive the flu vaccine every year and I attributed this to normal muscle pain associated with the vaccine. By Wednesday December 3rd, my pain had increased leading to lack of sleep at night and I was unable to perform simple tasks that required moving my arm.  I called my physician informing her of the issue and she told me it could take 7 to 10 days to heal if a nerve was hit.  On December 11th, I made an appointment with my physician since the pain was getting worse and my range of motion was more limited.  She was alarmed to see bruising on the upper part of my shoulder from the needle and informed me that this was not the proper place to administer the vaccine.  It was injected above the muscle in the area of the bursa. She was also concerned that this pharmacist was improperly trained on administering injectables and urged me to contact the pharmacy immediately.  I underwent xrays and an MRI to determine if any structural damage occurred to my shoulder.  I am currently undergoing physical therapy to alleviate pain and increase the range of motion in my shoulder.  Pharmacy did not return my call seeking assistance in reporting this issue.
Age: 41.0
Sex: F
Vaccine: FLU3, FLUX
Symptoms: Nuclear magnetic resonance imaging, Pain, X-ray limb
Clinical narrative: I went to Pharmacy the morning of 12/1/14 for a routine flu vaccine.  The vaccine was administered high into my left shoulder.  I did not think much of it at the time, but by early afternoon I began to experience pain and I was barely able to move my arm.  I receive the flu vaccine every year and I attributed this to normal muscle pain associated with the vaccine. By Wednesday December 3rd, my pain had increased leading to lack of sleep at night and I was unable to perform simple tasks that required moving my arm.  I called my physician informing her of the issue and she told me it could take 7 to 10 days to heal if a nerve was hit.  On December 11th, I made an appointment with my physician since the pain was getting worse and my range of motion was more limited.  She was alarmed to see bruising on the upper part of my shoulder from the needle and informed me that this was not the proper place to administer the vaccine.  It was injected above the muscle in the area of the bursa. She was also concerned that this pharmacist was improperly trained on administering injectables and urged me to contact the pharmacy immediately.  I underwent xrays and an MRI to determine if any structural damage occurred to my shoulder.  I am currently undergoing physical therapy to alleviate pain and increase the range of motion in my shoulder.  Pharmacy did not return my call seeking assistance in reporting this issue.
Age: 41.0
Sex: F
Vaccine: FLU3, FLUX
Symptoms: Activities of daily living impaired, Drug administered at inappropriate site, Injection site bruising, Insomnia, Mobility decreased
Clinical narrative: I went to Pharmacy the morning of 12/1/14 for a routine flu vaccine.  The vaccine was administered high into my left shoulder.  I did not think much of it at the time, but by early afternoon I began to experience pain and I was barely able to move my arm.  I receive the flu vaccine every year and I attributed this to normal muscle pain associated with the vaccine. By Wednesday December 3rd, my pain had increased leading to lack of sleep at night and I was unable to perform simple tasks that required moving my arm.  I called my physician informing her of the issue and she told me it could take 7 to 10 days to heal if a nerve was hit.  On December 11th, I made an appointment with my physician since the pain was getting worse and my range of motion was more limited.  She was alarmed to see bruising on the upper part of my shoulder from the needle and informed me that this was not the proper place to administer the vaccine.  It was injected above the muscle in the area of the bursa. She was also concerned that this pharmacist was improperly trained on administering injectables and urged me to contact the pharmacy immediately.  I underwent xrays and an MRI to determine if any structural damage occurred to my shoulder.  I am currently undergoing physical therapy to alleviate pain and increase the range of motion in my shoulder.  Pharmacy did not return my call seeking assistance in reporting this issue.
Age: 41.0
Sex: F
Vaccine: FLU3, FLUX
Symptoms: Myalgia, Pain
Clinical narrative: I went to Pharmacy the morning of 12/1/14 for a routine flu vaccine.  The vaccine was administered high into my left shoulder.  I did not think much of it at the time, but by early afternoon I began to experience pain and I was barely able to move my arm.  I receive the flu vaccine every year and I attributed this to normal muscle pain associated with the vaccine. By Wednesday December 3rd, my pain had increased leading to lack of sleep at night and I was unable to perform simple tasks that required moving my arm.  I called my physician informing her of the issue and she told me it could take 7 to 10 days to heal if a nerve was hit.  On December 11th, I made an appointment with my physician since the pain was getting worse and my range of motion was more limited.  She was alarmed to see bruising on the upper part of my shoulder from the needle and informed me that this was not the proper place to administer the vaccine.  It was injected above the muscle in the area of the bursa. She was also concerned that this pharmacist was improperly trained on administering injectables and urged me to contact the pharmacy immediately.  I underwent xrays and an MRI to determine if any structural damage occurred to my shoulder.  I am currently undergoing physical therapy to alleviate pain and increase the range of motion in my shoulder.  Pharmacy did not return my call seeking assistance in reporting this issue.
Age: 85.0
Sex: M
Vaccine: FLUX, TDAP
Symptoms: Erythema, Pain in extremity, Rash, Scab, Skin lesion
Clinical narrative: Bilateral leg pain, most severe in the left thigh bagan the night of 1/6, hours after receiving the Zostavax. The pain is a sharp stabbing in the left leg, and is a duller pain in the right leg. 2-3 days ago, a rash erupted from his coccyx down the posterior-medial left thigh. Lesions are covered by black scabs 2-4 cm on an erythematous base.
Age: 4.0
Sex: F
Vaccine: DTAPIPV, FLU3, MMRV
Symptoms: Hypersensitivity, Induration, Local reaction, Pruritus
Clinical narrative: Local allergic reaction: pink patch of indurated itchy skin.
Age: 56.0
Sex: F
Vaccine: VARZOS
Symptoms: Erythema, Peripheral swelling, Skin warm, Urticaria
Clinical narrative: Raised, reddened welt that is increasing in diameter on right arm.  Warm to touch. Afebrile. Keflex started on January 15, 2015.
Age: 60.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site erythema, Vaccination site pain, Vaccination site swelling
Clinical narrative: Swelling, sore, redness around site of vaccination.
Age: 73.0
Sex: F
Vaccine: VARZOS
Symptoms: Erythema, Peripheral swelling
Clinical narrative: Left posterior arm some redness, swelling size 4x2 inches.
Age: 1.13
Sex: F
Vaccine: MMR
Symptoms: Rash generalised
Clinical narrative: Diffuse rash. Also with URI and AOM so likely not due to vaccine.
Age: 13.0
Sex: F
Vaccine: HPV4
Symptoms: Arthralgia, Computerised tomogram, Headache, Nuclear magnetic resonance imaging, Tremor
Clinical narrative: Joint pain, Headaches, Uncontrolled shaking of extremities.
Age: 24.0
Sex: F
Vaccine: HPV4
Symptoms: Headache, Visual impairment
Clinical narrative: Headache; Disturbed vision.
Age: 52.0
Sex: F
Vaccine: PPV
Symptoms: Mobility decreased, Peripheral swelling, Skin warm, Tenderness
Clinical narrative: Arm warm to touch, swollen, and tender.  On 1/16/2015, she started to be able to bend elbow.  She consulted MD and told to take diphenhydramine.  I recommended to ice and ibuprofen 400-600mg every 6 hrs.