chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 46.0
Sex: F
Vaccine: COVID19
Symptoms: Ageusia, Amnesia, Chest X-ray, Chest pain, Computerised tomogram
Clinical narrative: Difficulty breathing, difficulty talking (run out of breath), sadness, trouble concentration, loss of memory, loss of taste, chest pain all caused by Vaccine Interactions with medication called Klonopin for epilepsy
Age: 46.0
Sex: F
Vaccine: COVID19
Symptoms: Depressed mood, Disturbance in attention, Dyspnoea, SARS-CoV-2 test
Clinical narrative: Difficulty breathing, difficulty talking (run out of breath), sadness, trouble concentration, loss of memory, loss of taste, chest pain all caused by Vaccine Interactions with medication called Klonopin for epilepsy
Age: 72.0
Sex: M
Vaccine: COVID19
Symptoms: Flow cytometry, Full blood count, Lymphocytosis, Monoclonal B-cell lymphocytosis
Clinical narrative: On 4/1/21, I was determined to have lymphocytosis.  It had not been present on three previous CBC's in the last months of 2020.  On 7/2/21, the lymphocytosis had worsened, and I was determined to have Monoclonal B Cell Lymphocytosis - CLL type.
Age: 67.0
Sex: F
Vaccine: COVID19
Symptoms: Cardiac flutter, Chest discomfort, Electrocardiogram
Clinical narrative: Chest raised and heart fluttered for about 5 seconds.  This happened twice 5 days a part.
Age: 56.0
Sex: M
Vaccine: COVID19
Symptoms: Chest pain, Electrocardiogram abnormal, Pleuritic pain
Clinical narrative: Pericarditits, mild chest pain, positional, pleurtic chest pain  reviewed ECG with cardiology who recommended treatment for mild pericarditis with ibuprofen tapered dosing  had abnormal ECG
Age: 75.0
Sex: M
Vaccine: COVID19
Symptoms: Blood creatine phosphokinase MB abnormal, Cardiac failure, Chills, Dehydration, Diastolic dysfunction
Clinical narrative: Pt with diagnosed heart failure. S/S:  Lethargy/Fatigue,  Fever/Chills, Onset 02/15/2021 Patient does not have myocarditis or pericarditis.  No new cardiac diagnosis given.   Patient has post vaccine dehydration and syncope.  Was not felt to have a stroke/thrombosis (brain MRI normal). Do not count in case load.  Patient also with hx of hypertension, past hx of breast cancer and adrenal adenomaq
Age: 75.0
Sex: M
Vaccine: COVID19
Symptoms: Echocardiogram abnormal, Ejection fraction, Electrocardiogram QT prolonged, Fatigue, Lethargy
Clinical narrative: Pt with diagnosed heart failure. S/S:  Lethargy/Fatigue,  Fever/Chills, Onset 02/15/2021 Patient does not have myocarditis or pericarditis.  No new cardiac diagnosis given.   Patient has post vaccine dehydration and syncope.  Was not felt to have a stroke/thrombosis (brain MRI normal). Do not count in case load.  Patient also with hx of hypertension, past hx of breast cancer and adrenal adenomaq
Age: 75.0
Sex: M
Vaccine: COVID19
Symptoms: Magnetic resonance imaging head normal, Pyrexia, Syncope, Troponin abnormal
Clinical narrative: Pt with diagnosed heart failure. S/S:  Lethargy/Fatigue,  Fever/Chills, Onset 02/15/2021 Patient does not have myocarditis or pericarditis.  No new cardiac diagnosis given.   Patient has post vaccine dehydration and syncope.  Was not felt to have a stroke/thrombosis (brain MRI normal). Do not count in case load.  Patient also with hx of hypertension, past hx of breast cancer and adrenal adenomaq
Age: 77.0
Sex: F
Vaccine: COVID19
Symptoms: C-reactive protein normal, Cardiomegaly, Chest X-ray abnormal, Chest discomfort, Chest pain
Clinical narrative: DX: Pericarditis onset 05/07/2021 Clinician description of chest pain: She now has some constant dull central chest pain and vague shortness of breath similar to her symptoms she had with her pericarditis. She is concerned this is either a reaction to the COVID vaccination or may be recurrent symptoms related to her recent pericarditis and concern for rheumatologic etiology.  CT Chest showed Cardiomegaly and small pericardial effusion, similar to 1/4/2021.  Mild abnormality of CXR may be baseline.  Mild abnormality in ECG.  Elevated inflammatory markers and normal troponin.  As above this easily could be a flare of a prior diagnosis of pericarditis due to being on a prednisone taper.  She is under the care of a Rheumatologist. Concerned this is either a reaction to the COVID vaccination or may be recurrent symptoms related to her recent pericarditis on a steroid taper and concern for rheumatologic etiology.    S/S: Dyspnea pn exertion, acute chest pain or pressure onset 05/03/2021
Age: 77.0
Sex: F
Vaccine: COVID19
Symptoms: Computerised tomogram thorax abnormal, Condition aggravated, Dyspnoea, Dyspnoea exertional, Electrocardiogram T wave inversion
Clinical narrative: DX: Pericarditis onset 05/07/2021 Clinician description of chest pain: She now has some constant dull central chest pain and vague shortness of breath similar to her symptoms she had with her pericarditis. She is concerned this is either a reaction to the COVID vaccination or may be recurrent symptoms related to her recent pericarditis and concern for rheumatologic etiology.  CT Chest showed Cardiomegaly and small pericardial effusion, similar to 1/4/2021.  Mild abnormality of CXR may be baseline.  Mild abnormality in ECG.  Elevated inflammatory markers and normal troponin.  As above this easily could be a flare of a prior diagnosis of pericarditis due to being on a prednisone taper.  She is under the care of a Rheumatologist. Concerned this is either a reaction to the COVID vaccination or may be recurrent symptoms related to her recent pericarditis on a steroid taper and concern for rheumatologic etiology.    S/S: Dyspnea pn exertion, acute chest pain or pressure onset 05/03/2021
Age: 77.0
Sex: F
Vaccine: COVID19
Symptoms: Electrocardiogram abnormal, Inflammatory marker increased, Pericardial effusion, Pericarditis, Red blood cell sedimentation rate abnormal
Clinical narrative: DX: Pericarditis onset 05/07/2021 Clinician description of chest pain: She now has some constant dull central chest pain and vague shortness of breath similar to her symptoms she had with her pericarditis. She is concerned this is either a reaction to the COVID vaccination or may be recurrent symptoms related to her recent pericarditis and concern for rheumatologic etiology.  CT Chest showed Cardiomegaly and small pericardial effusion, similar to 1/4/2021.  Mild abnormality of CXR may be baseline.  Mild abnormality in ECG.  Elevated inflammatory markers and normal troponin.  As above this easily could be a flare of a prior diagnosis of pericarditis due to being on a prednisone taper.  She is under the care of a Rheumatologist. Concerned this is either a reaction to the COVID vaccination or may be recurrent symptoms related to her recent pericarditis on a steroid taper and concern for rheumatologic etiology.    S/S: Dyspnea pn exertion, acute chest pain or pressure onset 05/03/2021
Age: 77.0
Sex: F
Vaccine: COVID19
Symptoms: SARS-CoV-2 test negative, Troponin normal, Viral test negative
Clinical narrative: DX: Pericarditis onset 05/07/2021 Clinician description of chest pain: She now has some constant dull central chest pain and vague shortness of breath similar to her symptoms she had with her pericarditis. She is concerned this is either a reaction to the COVID vaccination or may be recurrent symptoms related to her recent pericarditis and concern for rheumatologic etiology.  CT Chest showed Cardiomegaly and small pericardial effusion, similar to 1/4/2021.  Mild abnormality of CXR may be baseline.  Mild abnormality in ECG.  Elevated inflammatory markers and normal troponin.  As above this easily could be a flare of a prior diagnosis of pericarditis due to being on a prednisone taper.  She is under the care of a Rheumatologist. Concerned this is either a reaction to the COVID vaccination or may be recurrent symptoms related to her recent pericarditis on a steroid taper and concern for rheumatologic etiology.    S/S: Dyspnea pn exertion, acute chest pain or pressure onset 05/03/2021
Age: 16.0
Sex: M
Vaccine: COVID19
Symptoms: Injection site bruising, Injection site erythema, Injection site rash
Clinical narrative: The shot was to the right arm. After approximately 5-10 minutes after the shot, my son noticed on the underside of his lower left arm there was a streak of dark reddish clotting or bruising underneath the skin. He felt okay, with no adverse symptoms/reactions. I notified the pharmacist and believed it was a mild rash reaction and to wait for any adverse reaction. We went home afterward and the clotting/bruising went away after a few days. I am concerned about whether he should go ahead with a 2nd shot or be evaluated due to the immediate non-adverse reaction. My son took a picture of his left arm after we got home. So if you need to look at it, we have it.
Age: 51.0
Sex: F
Vaccine: COVID19
Symptoms: Arthralgia, Autoimmune disorder, Blood test, Chills, Demyelination
Clinical narrative: Noticeable Symptoms immediately after the 2nd shot - chills and sweating.  Months after the 2nd shot: Metallic taste - unable to eat, food tasted nasty Left shoulder and arm constant pain, especially when I lay down (Like constant cramping) Left hand fingers - numbness and tingling Left leg weakness Left hand weakness - hard to grip anything Demyelization to Pons and Superior Cerebellar region - ruled out MS and stroke, double vision cleared up after a month  Dr.  ( Ophthalmologist) prescribed Prednisone 20mg tab once a day  and Pyridostigmine BR 60mg tab 3 times a day - suspected Myasthnia gravis or other autoimmune disorder
Age: 51.0
Sex: F
Vaccine: COVID19
Symptoms: Diplopia, Dysgeusia, Feeding disorder, Grip strength decreased, Hemiparesis
Clinical narrative: Noticeable Symptoms immediately after the 2nd shot - chills and sweating.  Months after the 2nd shot: Metallic taste - unable to eat, food tasted nasty Left shoulder and arm constant pain, especially when I lay down (Like constant cramping) Left hand fingers - numbness and tingling Left leg weakness Left hand weakness - hard to grip anything Demyelization to Pons and Superior Cerebellar region - ruled out MS and stroke, double vision cleared up after a month  Dr.  ( Ophthalmologist) prescribed Prednisone 20mg tab once a day  and Pyridostigmine BR 60mg tab 3 times a day - suspected Myasthnia gravis or other autoimmune disorder
Age: 51.0
Sex: F
Vaccine: COVID19
Symptoms: Hyperhidrosis, Hypoaesthesia, Immediate post-injection reaction, Lumbar puncture, Magnetic resonance imaging head
Clinical narrative: Noticeable Symptoms immediately after the 2nd shot - chills and sweating.  Months after the 2nd shot: Metallic taste - unable to eat, food tasted nasty Left shoulder and arm constant pain, especially when I lay down (Like constant cramping) Left hand fingers - numbness and tingling Left leg weakness Left hand weakness - hard to grip anything Demyelization to Pons and Superior Cerebellar region - ruled out MS and stroke, double vision cleared up after a month  Dr.  ( Ophthalmologist) prescribed Prednisone 20mg tab once a day  and Pyridostigmine BR 60mg tab 3 times a day - suspected Myasthnia gravis or other autoimmune disorder
Age: 51.0
Sex: F
Vaccine: COVID19
Symptoms: Muscle spasms, Myasthenia gravis, Nystagmus, Pain in extremity, Paraesthesia
Clinical narrative: Noticeable Symptoms immediately after the 2nd shot - chills and sweating.  Months after the 2nd shot: Metallic taste - unable to eat, food tasted nasty Left shoulder and arm constant pain, especially when I lay down (Like constant cramping) Left hand fingers - numbness and tingling Left leg weakness Left hand weakness - hard to grip anything Demyelization to Pons and Superior Cerebellar region - ruled out MS and stroke, double vision cleared up after a month  Dr.  ( Ophthalmologist) prescribed Prednisone 20mg tab once a day  and Pyridostigmine BR 60mg tab 3 times a day - suspected Myasthnia gravis or other autoimmune disorder
Age: 51.0
Sex: F
Vaccine: COVID19
Symptoms: Taste disorder
Clinical narrative: Noticeable Symptoms immediately after the 2nd shot - chills and sweating.  Months after the 2nd shot: Metallic taste - unable to eat, food tasted nasty Left shoulder and arm constant pain, especially when I lay down (Like constant cramping) Left hand fingers - numbness and tingling Left leg weakness Left hand weakness - hard to grip anything Demyelization to Pons and Superior Cerebellar region - ruled out MS and stroke, double vision cleared up after a month  Dr.  ( Ophthalmologist) prescribed Prednisone 20mg tab once a day  and Pyridostigmine BR 60mg tab 3 times a day - suspected Myasthnia gravis or other autoimmune disorder
Age: 33.0
Sex: M
Vaccine: COVID19
Symptoms: Chest discomfort, Chest pain, Dyspnoea, Feeling hot, Hot flush
Clinical narrative: Tuesday (7/20, AM, after waking up) - Tight chest, slight shortness of breath while standing, lasting for about an hour. In the afternoon/early evening, short episode of feeling overheated and had to sit down during work. Wednesday (7/21, AM, after waking up) - Same as the day before, Tight chest, slight shortness of breath while standing, lasting for about an hour. In the afternoon/early evening, short episode of feeling overheated and had to sit down during work. Thursday (7/22, AM, after waking up) - Chest pain on the left side, specifically heart throbbing accompanied by hot flashes, persisted for about 45 min while standing.
Age: 33.0
Sex: M
Vaccine: COVID19
Symptoms: Palpitations
Clinical narrative: Tuesday (7/20, AM, after waking up) - Tight chest, slight shortness of breath while standing, lasting for about an hour. In the afternoon/early evening, short episode of feeling overheated and had to sit down during work. Wednesday (7/21, AM, after waking up) - Same as the day before, Tight chest, slight shortness of breath while standing, lasting for about an hour. In the afternoon/early evening, short episode of feeling overheated and had to sit down during work. Thursday (7/22, AM, after waking up) - Chest pain on the left side, specifically heart throbbing accompanied by hot flashes, persisted for about 45 min while standing.
Age: 37.0
Sex: F
Vaccine: UNK
Symptoms: Amenorrhoea, Skin disorder
Clinical narrative: I didnt get my period nomore. Have skin problems  on my legs
Age: 20.0
Sex: F
Vaccine: COVID19
Symptoms: Chills, Headache, Nausea, Pain in extremity, Pyrexia
Clinical narrative: Body chills,arm pain,headache,nausea, vomiting and 100.1 fever a day after vaccine
Age: 20.0
Sex: F
Vaccine: COVID19
Symptoms: Vomiting
Clinical narrative: Body chills,arm pain,headache,nausea, vomiting and 100.1 fever a day after vaccine
Age: 58.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Allergy test, Arthralgia, Gastritis, Oesophagogastroduodenoscopy, Polyarthritis
Clinical narrative: Extreme joint pain-advancement of arthritis to all joints. 2/2021 Referred to rheumatologist (appointment 9/20/2021) Severe gastritis-emergent EGD 3/5/2021  Extreme allergies-referral to ENT. Underwent allergy testing and started in immunotherapy 5/2021. Underwent sinus surgery for extreme congestion 6/18/2021
Age: 58.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Respiratory tract congestion, Sinus operation
Clinical narrative: Extreme joint pain-advancement of arthritis to all joints. 2/2021 Referred to rheumatologist (appointment 9/20/2021) Severe gastritis-emergent EGD 3/5/2021  Extreme allergies-referral to ENT. Underwent allergy testing and started in immunotherapy 5/2021. Underwent sinus surgery for extreme congestion 6/18/2021
Age: 43.0
Sex: F
Vaccine: COVID19
Symptoms: Dizziness, Headache, Nausea
Clinical narrative: Extreme dizziness, nausea, mild headache.  No treatment, just rest and taking it easy.  It happened several times, every few weeks for about 1 1/2 months.  Still have feelings of dizziness coming on but it doesn't get as bad as it had been.  Doctor thinks it might be migraines or BPPV?
Age: 33.0
Sex: F
Vaccine: COVID19
Symptoms: Cardiac failure, Cardioversion, Ejection fraction decreased, Laboratory test, Myopathy
Clinical narrative: Heart failure (myopathy). Began with fluid accumulation in lungs, eventually led to hospitalization within weeks. Ejection fraction was at 18%. Treated with hospitalization, medication, cardiac rehabilitation therapy, defibrillator vest.
Age: 33.0
Sex: F
Vaccine: COVID19
Symptoms: Pulmonary oedema
Clinical narrative: Heart failure (myopathy). Began with fluid accumulation in lungs, eventually led to hospitalization within weeks. Ejection fraction was at 18%. Treated with hospitalization, medication, cardiac rehabilitation therapy, defibrillator vest.
Sex: U
Vaccine: MMRV
Symptoms: No adverse event, Product storage error
Clinical narrative: No additional AE reported; an improperly stored dose of PROQUAD was administered today; The patient was suppose to receive MMR II but the PROQUAD was inadvertently administered instead.; The patient was suppose to receive MMR II but the PROQUAD was inadvertently administered instead.; This spontaneous report was received from a nurse practitioner and refers to a patient of unknown age and gender. No information regarding the patient's pertinent medical history and drug reactions or allergies was provided.  On 30-JUN-2021, the patient was inadvertently vaccinated with an improperly stored dose of measles, mumps, rubella and varicella (oka-merck) virus vaccine live (PROQUAD) recombinant human albumin (rHA), lot # T036562, expiration date 26-APR-2022, 1 injection for prophylaxis (exact dose, anatomical location and route of administration were not reported) instead of planned measles, mumps, and rubella (wistar ra 27-3) virus vaccine, live (M-M-R II). Concomitant therapies included varicella virus vaccine live (oka/merck) (VARIVAX) administered on the same day (lot # T032316, expiration date 22-SEP-2022) for prophylaxis.   Digital Data logger was not involved. The measles, mumps, rubella and varicella (oka-merck) virus vaccine live (PROQUAD) was stored at the temperature that was reported as from 14 degrees of Fahrenheit to 46 degrees of Fahrenheit (42.9 degrees of Fahrenheit) for 336 hours. There was no previous temperature excursion reported.  No additional adverse event reported.
Age: 65.0
Sex: F
Vaccine: VARZOS
Symptoms: Unevaluable event
Clinical narrative: other zoster-related conditions; shingles; This initial spontaneous report was received from a lawyer regarding a case in litigation and refers to a currently 71 year old female patient. The patient's pertinent medical history, concurrent conditions, or concomitant medications were not provided. In 2015, the patient was vaccinated with a dose of vaccine live (ZOSTAVAX) (lot#, expiration date, dose, dose# and route not specified) for the long-term prevention of shingles and zoster-related conditions. On an unspecified date, the patient was treated for shingles and other zoster-related conditions at the hospital. The outcome of the events was not reported. The reporter considered the events to be related to zoster vaccine live (ZOSTAVAX).
Age: 1.5
Sex: F
Vaccine: MMR
Symptoms: Pain, Unevaluable event
Clinical narrative: Tramadol for pain; Alprazolam pre procedural; Expired M-M-R II (expiration 21-JUN-2021); On 25-JUN-2021 the patient received a third dose of M-M-R II; This spontaneous report as received from a registered nurse and refers to a 28 year old female patient. The patient's concurrent conditions included hidradenitis, obesity, vitamin d deficiency, vitamin b12 deficiency and menstruation irregular. Her concomitant therapies included lidocaine patch. Her medical history was not reported.  On 09-APR-1994, the patient received a first dose of measles, mumps, and rubella (wistar ra 27-3) virus vaccine, live(M-M-R II) (lot #, expiration date, dose, route and frequency were not reported) for prophylaxis. On 09-JUN-1997, the patient received a second dose of measles, mumps, and rubella (wistar ra 27-3) virus vaccine, live (M-M-R II) (lot #, expiration date, dose, route and frequency were not reported) for prophylaxis. On 25-JUN-2021 the patient received a third dose of measles, mumps, and rubella (wistar ra 27-3) virus vaccine, live (M-M-R II) lot # S018594 (expiration date reported as 21-JUN-2021, but upon internal validation, established as 17-JUN-2021), albumin status rHA,subcutaneously in the left upper arm, for prophylaxis.      On an unreported date, the patient experienced an unspecified event and, due to that, she underwent an unspecified procedure, that was treated with alprazolam 0.25 milligram, 3 tablets, prior the procedure, on 30-JUN-2021. Besides, on an unreported date, the patient experienced pain (unspecified) that was treated with tramadol, 50 milligram orally, as needed, administered since 08-JUL-2021. In addition, the reporter stated that the involved vaccine was not available for return and evaluation, as it was disposed after injection. Also, the reporter stated that the patient's titer would be measured in order to determine the vaccine's efficacy (results not yet available).  At the reporting time, the outcome of the events was not reported. The reporter did not provide a causal relationship between the events and measles, mumps, and rubella (wistar ra 27-3) virus vaccine, live (M-M-R II).
Sex: F
Vaccine: VARZOS
Symptoms: Polymyalgia rheumatica
Clinical narrative: Polymyalgia rheumatica; This spontaneous report was received from a lawyer regarding a case in litigation and refers to a female patient of unknown age. No information was provided regarding medical history, concurrent conditions, or concomitant medications. In or around May 2012, the patient was vaccinated with zoster vaccine live (ZOSTAVAX) (dose, route, and lot # not provided) for routine health maintenance and for its intended purpose: the prevention of shingles (herpes zoster).               On an unspecified date, "shortly after" receiving zoster vaccine live (ZOSTAVAX), the patient experienced polymyalgia rheumatica. As a direct and proximate result of the defective Zoster Vaccine Live (ZOSTAVAX), the patient's symptoms have resulted in physical limitations not present prior to using the zoster vaccine live (ZOSTAVAX). The patient also experienced mental and emotional distress due to resulting physical limitations and seriousness of patient's condition. As a result of Zoster Vaccine Live (ZOSTAVAX), Plaintiff sustained severe and permanent personal injuries. The outcome of the event was considered as not recovered.     The reporter considered polymyalgia rheumatica to be related to Zoster Vaccine Live (ZOSTAVAX).  Polymyalgia rheumatica was considered to be disabling.  Upon internal review polymyalgia rheumatica was considered to be medically significant.
Age: 1.5
Sex: U
Vaccine: HEPA, UNK
Symptoms: Expired product administered, No adverse event
Clinical narrative: No additional AE details are available; administered an expired dose of VAQTA; This spontaneous report was received from a Nurse and refers to a 18-month-old patient of unknown gender. There was no information about the patient's concurrent conditions, concomitant therapies or medical history provided.  On 12-JUL-2021, the patient was vaccinated with an expired hepatitis a vaccine, inactivated (VAQTA) lot # T008698, expiration date 04-JUN-2021, dose of 0.5 milliliter (formulation, anatomical location and route of administration were not reported) for prophylaxis (expired product administered). No additional AE details were available. The outcome was not reported. combinationproductreport: Yes; brandname: VAQTA SYRINGE (DEVICE); commondevicename: Hepatitis A Vaccine, Inactivated; productcode: FMF; devicetype: SYRINGE, PISTON (FMF); manufacturername: Merck Sharp & Dohme Corp.; devicelotnumber: T008698; expirationdate: 04-JUN-2021; deviceage and unit: 0 ; malfunction: Unknown; deviceusage: Initial; reasonfornoneval: 81 Other; labeledsingleusedevice: No; mdcpreportability: No; mdcpreprationale: Case information does not meet criteria for reportability
Sex: U
Vaccine: MMR
Symptoms: Expired product administered, No adverse event
Clinical narrative: No other AE reported; The patient inadvertently received an expired dose of MMR II; This spontaneous report has been received from a medical assistant concerning a patient of unknown age and gender. The patient's pertinent medical history, drug reactions/allergies, concurrent condition and concomitant medication were not provided.  On 13-JUL-2021, the patient was vaccinated with Measles, Mumps, and Rubella (Wistar RA 27-3) Virus Vaccine, Live, recombinant human albumin (rHA) (M-M-R II) (lot# S020160 has been verified to be a valid lot number and expiration date was 30-JUN-2021; strength, dose, frequency and route were not reported) for prophylaxis (expired product administered). The reporter wanted to know if the dose was valid. There was no prior temperature excursion on this vaccine. There was no other adverse event reported. The outcome of the events was unknown.
Age: 73.0
Sex: M
Vaccine: VARZOS
Symptoms: Herpes zoster, Ill-defined disorder
Clinical narrative: ill-defined disorder; shingles; Information has been received from a lawyer, regarding a case in litigation, and referred to a elderly male patient (pt) of unknown age.  No information about the pt's medical history, concurrent conditions and concomitant medications was provided. On or around 29-APR-2014, the pt was inoculated, by a pharmacist, with zoster vaccine live (ZOSTAVAX) (strength, dose, route of administration, anatomical location, lot # and expiration date were not provided) for the long-term prevention of shingles and zoster-related conditions.On an unknown date (reported as "subsequently"), the pt experienced shingles and other zoster-related condition (Ill-defined disorder); and was treated by a healthcare provider (unspecified).  The outcome of the events was not reported. The reporter consider the events to be related to zoster vaccine live (ZOSTAVAX).
Age: 61.0
Sex: U
Vaccine: VARZOS
Symptoms: Herpes zoster, Ill-defined disorder
Clinical narrative: ill-defined disorder; herpes zoster; This spontaneous report was received from a lawyer and refers to a currently 67 years old patient of unknown gender concerning a case in litigation. The patient's concurrent conditions, medical history, historical drugs and concomitant medication were not reported.    On or about 09-MAR-2015, the patient was vaccinated with zoster vaccine live (ZOSTAVAX) (dose, route, lot number and expiration date were not reported) for the long prevention of shingles and zoster-related conditions.  On an unknown date (reported as subsequently), the patient experienced herpes zoster and other zoster related conditions (ill-defined disorder) and was treated by a physician.      The outcome of ill-defined disorder and herpes zoster was unknown.     The reporter considered herpes zoster and ill-defined disorder to be related to Zoster Vaccine Live (ZOSTAVAX).
Age: 1.0
Sex: U
Vaccine: VARCEL
Symptoms: Expired product administered, No adverse event
Clinical narrative: No additional AE reported; an expired VARIVAX was administered to the patient; This spontaneous report has been received from a medical assistant concerning a 12 months old patient of unknown gender. The patient's pertinent medical history, drug reactions/allergies, concurrent condition and concomitant medication were not provided.  On 12-JUL-2021, the patient was vaccinated with varicella virus vaccine live (Oka/Merck) (VARIVAX) (0.5 milliliter, lot# S021322 has been verified to be a valid lot number and expiration date was 09-JUL-2021; strength and route were not reported) for prophylaxis (expired product administered). This vaccine had no prior temperature excursions. There was no additional adverse event reported. The outcome of the events was unknown.
Age: 0.33
Sex: M
Vaccine: RV5
Symptoms: Inappropriate schedule of product administration
Clinical narrative: A patient receieved first dose of ROTATEQ late; This spontaneous report was received from a nurse and refers to a 4-month-old male patient.  The patient's concurrent conditions, medical history, concomitant medications, drugs reactions or allergies were not provided.  On 15-JUL-2021, the patient was vaccinated with a first dose of rotavirus vaccine, live, oral, pentavalent(ROTATEQ), lot # 1707457 with expiration date: 23-FEB-2022 (dose and strength were not provided) for prophylaxis. The patient received the first dose to late.(inappropriate schedule of product administration).
Sex: U
Vaccine: MMRV, VARCEL
Symptoms: Inappropriate schedule of product administration, No adverse event
Clinical narrative: No additional AE reported; the patient was inadvertently given PROQUAD and VARIVAX on the same day; the patient was inadvertently given PROQUAD and VARIVAX on the same day; This spontaneous report was received from a certified medical assistant and refers to a patient of unknown age and gender. There was no information regarding their medical history, concurrent conditions nor concomitant therapies provided.  On 16-JUL-2021, the patient was inadvertently vaccinated with measles, mumps, rubella and varicella (Oka-Merck) virus vaccine live (PROQUAD) 0.5 ml (route of administration, anatomical location, lot # and expiration date were not provided) and varicella virus vaccine live (Oka/Merck) (VARIVAX) 0.5 ml (route of administration, anatomical location, lot # and expiration date were not provided) for prophylaxis (inappropriate schedule of vaccine administered, extra dose administered). No adverse event (AE) was reported.
Sex: U
Vaccine: RV5
Symptoms: Product storage error
Clinical narrative: temperature excursion for ROTATEQ; This spontaneous report as received from a physician refers to a patient of unknown age and gender. The patient's concurrent conditions, medical history and concomitant therapies were not reported.   On 02-APR-2021, the patient's were vaccinated with inappropriate stored dose of rotavirus vaccine, live, oral, pentavalent (ROTATEQ), orally lot# 1691299 and expiration date of 21-DEC-2021 (strength and dose were not provided) for prophylaxis. The temperature excursions were the following: Temperature (0.7°C) for 54 hours and 45 minutes; (8.6°C) for 47 hours 15 minutes. There was no previous temperature excursion. The call was registered due to a data logger. The adverse event report was filled precautionary.   This is one of several reports received from the same reporter
Sex: U
Vaccine: RV5
Symptoms: Product storage error
Clinical narrative: temperature excursion for ROTATEQ; This spontaneous report as received from a physician refers to a patient of unknown age and gender. The patient's concurrent conditions, medical history and concomitant therapies were not reported.   On 30-APR-2021, the patient's were vaccinated with inappropriate stored dose of rotavirus vaccine, live, oral, pentavalent (ROTATEQ), orally lot# 1691299 and expiration date of 21-DEC-2021 (strength and dose were not provided) for prophylaxis. The temperature excursions were the following: Temperature (0.7°C) for 54 hours and 45 minutes; (8.6°C) for 47 hours 15 minutes. There was no previous temperature excursion. The call was registered due to a data logger. The adverse event report was filled precautionary.   This is one of several reports received from the same reporter
Sex: U
Vaccine: RV5
Symptoms: Incorrect dose administered, No adverse event
Clinical narrative: temperature excursion for ROTATEQ; This spontaneous report as received from a physician refers to a patient of unknown age and gender. The patient's concurrent conditions, medical history and concomitant therapies were not reported.   On 26-MAY-2021, the patient's were vaccinated with inappropriate stored dose of rotavirus vaccine, live, oral, pentavalent (ROTATEQ), orally lot# 1691299 and expiration date of 21-DEC-2021 (strength and dose were not provided) for prophylaxis. The temperature excursions were the following: Temperature (0.7°C) for 54 hours and 45 minutes; (8.6°C) for 47 hours 15 minutes. There was no previous temperature excursion. The call was registered due to a data logger. The adverse event report was filled precautionary.   This is one of several reports received from the same reporter
Sex: U
Vaccine: HEP
Symptoms: Incorrect dose administered
Clinical narrative: Gave Patient a 40 mcg Dose of Heplisav-B; Initial Report Received on 10-Jun-2021  A registered nurse reported that a patient (age, gender, race, and ethnicity not provided) received a 40 mcg dose of HEPLISAV-B (hepatitis B vaccine) for hepatitis B immunization.   No relevant medical history was reported.  No relevant concomitant medications were reported.  On 04-Jun-2021, the patient received a 40 mcg dose of HEPLISAV-B (Lot #, expiration date, NDC #, serial number, route, and site were not reported) from the nurse. No additional information was provided.   Company Comment: The  company assessed the event as non-serious.; Sender's Comments: The  company assessed the event as non-serious.
Sex: U
Vaccine: HEP
Symptoms: Incorrect dose administered
Clinical narrative: Administered 40 mcg; Initial Report Received on 10-Jun-2021  A registered nurse reported that a patient (age, gender, race, and ethnicity not provided) received a 40 mcg dose of HEPLISAV-B (hepatitis B vaccine) for hepatitis B immunization.   No relevant medical history was reported.  No relevant concomitant medications were reported.  On an unknown date, the patient received a 40 mcg dose of HEPLISAV-B (Lot #, expiration date, NDC #, serial number, route, and site were not reported). No additional information was provided.   Company Comment: The company assessed the event as non-serious.; Sender's Comments: The company assessed the event as non-serious.
Sex: U
Vaccine: HEP
Symptoms: Incorrect dose administered
Clinical narrative: Gave Patient 40 mcg Dose of Heplisav-B; Initial Report Received on 10-Jun-2021  A registered nurse reported that a patient (age, gender, race, and ethnicity not provided) received a 40 mcg dose of HEPLISAV-B (hepatitis B vaccine) for hepatitis B immunization.   No relevant medical history was reported.  No relevant concomitant medications were reported.  On an unknown date, the patient received a 40 mcg dose of HEPLISAV-B (Lot #, expiration date, NDC #, serial number, route, and site were not reported). No additional information was provided.   Company Comment: The company assessed the event as non-serious.; Sender's Comments: The company assessed the event as non-serious.
Sex: U
Vaccine: HEP
Symptoms: Incorrect dose administered
Clinical narrative: Gave 40 mcg Dose of Heplisav-B; Initial Report Received on 10-Jun-2021  A registered nurse reported that a patient (age, gender, race, and ethnicity not provided) received a 40 mcg dose of HEPLISAV-B (hepatitis B vaccine) for hepatitis B immunization.   No relevant medical history was reported.  No relevant concomitant medications were reported.  On 04-Jun-2021, the patient received a 40 mcg dose of HEPLISAV-B (Lot #, expiration date, NDC #, serial number, route, and site were not reported) from the registered nurse. No additional information was provided.   Company Comment: The company assessed the event as non serious.; Sender's Comments: The company assessed the event as non serious.
Sex: U
Vaccine: HEP
Symptoms: Product temperature excursion issue
Clinical narrative: Temperature Excursion; HEPLISAV-B Temperature Excursion Product Administered; Initial Report Received on 22-Jun-2021  A nurse reported that a male (age, race, and ethnicity unknown) was administered HEPLISAV-B (hepatitis B vaccine) for hepatitis B immunization after a temperature excursion occurred that was above the recommended temperature and time.  Medical history was reported as none.  No relevant concomitant medications were reported.    On 07-Jun-2021, the patient received a dose of HEPLISAV-B (Lot # 934600, expiration date 25-Feb-2022 and NDC # 43528-003-05) from a nurse at a travel clinic.  The HEPLISAV-B had a temperature excursion that was above the recommended temperature and time. On that day, the temperature reached 12 degrees Celsius for 24 hours. Another excursion occurred in which the temperature reached a high of 13.9 degrees Celsius over a 2-3-day period.  No additional information was reported.   Company Comment: The company assessed the events as non serious.; Sender's Comments: The company assessed the events as non serious.
Sex: U
Vaccine: VARZOS
Symptoms: Herpes zoster, Rash papular, Rash pruritic
Clinical narrative: got the shingrix vaccine both shots / Two weeks later started breaking out with shingles / Got shingles after getting the vaccine; Small bumps itching like crazy; Small bumps / small bumps got some on my arms and a few on my legs.; This case was reported by a consumer via call center representative and described the occurrence of shingles in a patient who received Herpes zoster (Shingrix) for prophylaxis.   On an unknown date, the patient received the 2nd dose of Shingrix. On an unknown date, 2 weeks after receiving Shingrix, the patient experienced shingles, itchy rash and papular rash. On an unknown date, the outcome of the shingles, itchy rash and papular rash were unknown.   It was unknown if the reporter considered the shingles, itchy rash and papular rash to be related to Shingrix.  Additional details were provided as follows: This case was reported by patient herself/himself The age at vaccination was not reported. The patient stated that he/she did not had an outbreak before the shot. The patient had received both the shots of Shingrix and two weeks later started breaking out with shingles. The patient had small bumps itching like crazy and got some small bumps on his/her arms and a few on his/her legs. The reporter asked why he/she was breaking out with shingles after receiving the shots. The follow-up would not possible as no contact details were available
Sex: F
Vaccine: VARZOS
Symptoms: Dry skin, Injected limb mobility decreased, Injection site erythema, Oral herpes
Clinical narrative: had cold sores (oral herpes); This case was reported by a consumer via other manufacturer and described the occurrence of cold sores in a 60-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   Co-suspect products included dupilumab (Dupixent) solution for injection (batch number unknown, expiry date 30th April 2022) for asthma and atopic dermatitis.   Concurrent medical conditions included asthma and atopic dermatitis.   On an unknown date, the patient received the 2nd dose of Shingrix and Dupixent (subcutaneous) 300 mg weekly. On an unknown date, unknown after receiving Shingrix, the patient experienced cold sores. The action taken with Dupixent was unknown. On an unknown date, the outcome of the cold sores was unknown.   It was unknown if the reporter considered the cold sores to be related to Shingrix.  Additional details were provided as follows:  The patient had reported the case for herself. The age at vaccination was not reported. On an unknown date, the patient started taking dupilumab injection liquid (solution) at 300 mg dose every other week (strength: 300mg/2ml; with an unknown batch number) and varicella zoster vaccine RGE (CHO) (with an unknown dosage, frequency, indication, route and batch number).  In the context of COVID19 crisis, the batch number was not requested. The patient reported that she had adverse reaction, onset and latency was unknown while on Dupilumab and after her second varicella zoster vaccine. The patient experienced dry red patch quarter size to injection site, injection site rash, injection site erythema twice over the last month that resolved on its own.  The patient also had cold sores (oral herpes) unknown date in 2019 and latency was unknown a couple of times over the last year. The patient got quarter size spots on her belly from the syringe that was why she wanted to try pen. On 25th June 2021, the product technical complaint was initiated for dupilumab and investigation was still in process. No lab data was reported. It was not reported if the patient received a corrective treatment or not. It was unknown if the reporter considered the cold sores to be related to Dupixent. The consent to follow-up was requested.
Sex: U
Vaccine: VARZOS
Symptoms: Herpes zoster
Clinical narrative: Got the shot....soon after I got shingles./Had the shot..a week later I had shingles.; This case was reported by a consumer via interactive digital media and described the occurrence of shingles in a patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   On an unknown date, the patient received the 1st dose of Shingles vaccine. On an unknown date, 1 week after receiving Shingles vaccine, the patient experienced shingles. On an unknown date, the outcome of the shingles was unknown.   It was unknown if the reporter considered the shingles to be related to Shingles vaccine.  Additional details were provided as follows: The patient reported the case for herself/himself. The age at vaccination was not reported. The patient received Shingles vaccine and a week later experienced shingles. The follow up would not be possible as no contact details were available.
Sex: U
Vaccine: VARZOS
Symptoms: Incomplete course of vaccination
Clinical narrative: 2nd dose greater than a year?; This case was reported by a consumer via interactive digital media and described the occurrence of incomplete course of vaccination in a patient who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included Shingrix (1st dose received on an unknown date).   On an unknown date, the patient received the 2nd dose of Shingrix. On an unknown date, unknown after receiving Shingrix, the patient experienced incomplete course of vaccination. On an unknown date, the outcome of the incomplete course of vaccination was unknown.  Additional details were provided as follows: The reporter was the patient. The age at vaccination was not applicable for this report. The reporter asked for if 2nd dose greater than a year, which led to incomplete course of vaccination.
Sex: U
Vaccine: VARZOS
Symptoms: Incorrect route of product administration
Clinical narrative: Shingrix in the subcutaneous area of my arm; This case was reported by a consumer via interactive digital media and described the occurrence of intramuscular formulation administered by other route in a patient who received Herpes zoster (Shingrix) for prophylaxis.   On an unknown date, the patient received Shingrix (subcutaneous). On an unknown date, unknown after receiving Shingrix, the patient experienced intramuscular formulation administered by other route. On an unknown date, the outcome of the intramuscular formulation administered by other route was unknown.  Additional details were provided as follows: The reporter was the patient. The reporter stated that, received shingrix vaccine via subcutaneous route, which led to intramuscular formulation administered by other route.
Sex: U
Vaccine: VARZOS
Symptoms: Asthenia, Fall, Gait disturbance
Clinical narrative: loss of strength; radical change./ began in my legs and then moved thru my body/ the vaccine entered into my nervous system; lost my gate and stumble quite often; I've fallen twice last week/stumble quite often; This case was reported by a consumer and described the occurrence of strength loss of in a patient who received Herpes zoster (Shingrix) for prophylaxis.   On 1st February 2021, the patient received the 2nd dose of Shingrix. On 9th February 2021, 8 days after receiving Shingrix, the patient experienced strength loss of, radiating pain, walking difficulty and fall. On an unknown date, the outcome of the strength loss of, radiating pain, walking difficulty and fall were unknown.   It was unknown if the reporter considered the strength loss of, radiating pain, walking difficulty and fall to be related to Shingrix.  Additional details were provided are as follows: The age at vaccination was not reported. The patient received 2nd dose of Shingrix and his/her body went into a radical change, began in legs and then moved to body and he/she could still felt where the shot was given, lost his/her gate and stumble quite often and had fallen twice last week and believed that vaccine entered into nervous system and the shot was given on the left side and felt often loss of strength mostly on that side. The reporter asked question that would this dissipate or would this be permanent-way of life for him.
Sex: U
Vaccine: VARZOS
Symptoms: Herpes zoster, Vaccination failure
Clinical narrative: had that shot and still got shingles!/ Suspected Vaccination failure; had that shot and still got shingles!; This case was reported by a consumer via interactive digital media and described the occurrence of suspected vaccination failure in a patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   On an unknown date, the patient received Shingles vaccine. On an unknown date, unknown after receiving Shingles vaccine, the patient experienced vaccination failure (serious criteria GSK medically significant) and shingles. On an unknown date, the outcome of the vaccination failure and shingles were unknown.   It was unknown if the reporter considered the vaccination failure and shingles to be related to Shingles vaccine.  Additional details were provided as follows: The case was reported by the patient. The age at vaccination was not reported. The patient stated that, he or she also had the shot and still got shingles. This case was considered as suspected vaccination failure as details regarding completion of primary vaccination schedule, time to onset for shingles and laboratory confirmation regarding shingles were unknown at the time of reporting.
Sex: U
Vaccine: VARZOS, VARZOS
Symptoms: Condition aggravated, Herpes zoster, Vaccination failure
Clinical narrative: suspected vaccination failure; I have shingles all my life/i took all shots/nothing helps/they pop out any time.; This case was reported by a consumer via interactive digital media and described the occurrence of suspected vaccination failure in a elderly patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   Co-suspect products included Herpes zoster (Shingles vaccine) for prophylaxis.   The patient's past medical history included shingles.   On an unknown date, the patient received the 2nd dose of Shingles vaccine and the 1st dose of Shingles vaccine. On an unknown date, unknown after receiving Shingles vaccine and Shingles vaccine, the patient experienced vaccination failure (serious criteria GSK medically significant) and shingles. On an unknown date, the outcome of the vaccination failure and shingles were unknown.   It was unknown if the reporter considered the vaccination failure and shingles to be related to Shingles vaccine and Shingles vaccine.  Additional details were provided as follows: The patient had reported for him/herself. The patient was 74-year-old at the time of reporting. The age at vaccination was not reported. The patient reported that, he/she had shingles all him/her life. After receiving all shots of Shingles vaccine, nothing helped, and the patient got shingles.  The patient stated that, shingles popped out any time. This case was considered as suspected vaccination failure, since the details regarding the completion of the primary immunization, time to onset for event and laboratory confirmation were not provided.
Sex: U
Vaccine: VARZOS
Symptoms: Herpes zoster, Illness, Vaccination failure
Clinical narrative: Suspected Vaccination failure; was vaccinated but still got them!; been sicker but never so miserable!; This case was reported by a consumer via interactive digital media and described the occurrence of suspected vaccination failure in a patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   On an unknown date, the patient received Shingles vaccine. On an unknown date, unknown after receiving Shingles vaccine, the patient experienced vaccination failure (serious criteria GSK medically significant), shingles and sickness. On an unknown date, the outcome of the vaccination failure, shingles and sickness were unknown.   It was unknown if the reporter considered the vaccination failure, shingles and sickness to be related to Shingles vaccine.  Additional details were provided as follows: The patient had reported for him/herself. The age at vaccination was not reported. After receiving Shingles vaccine, the patient still got shingles.  The patient had been sicker but never so miserable. The patient stated that, now there was a much more effective vaccine to get it. He/she sure did. This case was considered as suspected vaccination failure, since the details regarding the completion of the primary immunization, time to onset for event and laboratory confirmation were not provided.