chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 70.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Respiratory arrest, Respiratory syncytial virus test negative, SARS-CoV-2 test negative
Clinical narrative: V-Fib, cardiac arrest Narrative:  First COVID vaccine administered 2/25/21 with no noted reaction. Patient received his second COVID vaccine 3/21/21 at 1203. Notes in electronic medical record indicate in the morning of 3/22/21 he arrived at a hospital with ER this morning in V-Fib/cardiac arrest. Unclear of potential treatment that was administered at outside facility. Time of Death was about 1330 on 3/22/21.
Age: 70.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Cardiac arrest, Death, Ventricular fibrillation
Clinical narrative: V-Fib, cardiac arrest Narrative:  First COVID vaccine administered 2/25/21 with no noted reaction. Patient received his second COVID vaccine 3/21/21 at 1203. Notes in electronic medical record indicate in the morning of 3/22/21 he arrived at a hospital with ER this morning in V-Fib/cardiac arrest. Unclear of potential treatment that was administered at outside facility. Time of Death was about 1330 on 3/22/21.
Age: 44.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Blood potassium decreased, Blood test abnormal, Dizziness, Hypersensitivity, Pallor
Clinical narrative: Pt c/o throat closing and tongue swelling. Nurse was notified at 14:18. EMS activated by EMT BP: 130/80. HR: 66. Pt appeared pale and gray. At 14:20. Epinephrine 0.3mg adm x 1 IM (L vastus Lateralis) by the RN. at 14:22, pt sts feeling better. At 14:25, pt sts throat feels as if closing and tongue swelling again. EMS has arrived at that time and pt agreed to be transported and they took over her care.
Age: 44.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Throat tightness
Clinical narrative: Pt c/o throat closing and tongue swelling. Nurse was notified at 14:18. EMS activated by EMT BP: 130/80. HR: 66. Pt appeared pale and gray. At 14:20. Epinephrine 0.3mg adm x 1 IM (L vastus Lateralis) by the RN. at 14:22, pt sts feeling better. At 14:25, pt sts throat feels as if closing and tongue swelling again. EMS has arrived at that time and pt agreed to be transported and they took over her care.
Age: 44.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Blood potassium decreased, Laboratory test, Pallor, Swollen tongue, Throat tightness
Clinical narrative: Pt c/o throat closing and tongue swelling. Nurse was notified at 14:18. EMS activated by EMT BP: 130/80. HR: 66. Pt appeared pale and gray. At 14:20. Epinephrine 0.3mg adm x 1 IM (L vastus Lateralis) by the RN. at 14:22, pt sts feeling better. At 14:25, pt sts throat feels as if closing and tongue swelling again. EMS has arrived at that time and pt agreed to be transported and they took over her care.
Age: 47.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Hypersensitivity, Lip swelling, Periorbital swelling, Rash, Rash papular
Clinical narrative: rash, lip swelling
Age: 47.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Rash pruritic, Urticaria
Clinical narrative: rash, lip swelling
Age: 47.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Lip swelling, Rash
Clinical narrative: rash, lip swelling
Age: 26.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Anaphylactic reaction, Vaccination complication
Clinical narrative: Systemic: Allergic: Difficulty Breathing-Medium, Systemic: Allergic: Difficulty Swallowing, Throat Tightness-Severe, Systemic: Allergic: Rash Generalized-Medium
Age: 26.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Dysphagia, Dyspnoea, Rash, Throat tightness
Clinical narrative: Systemic: Allergic: Difficulty Breathing-Medium, Systemic: Allergic: Difficulty Swallowing, Throat Tightness-Severe, Systemic: Allergic: Rash Generalized-Medium
Age: 74.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Alanine aminotransferase normal, Albumin globulin ratio, Anion gap normal, Aspartate aminotransferase normal, Bacterial test negative
Clinical narrative: patient received COVID-19 vaccine on 3/8 with symptoms starting on 3/12. patient complains of excruciating pain all over the body and headache. Stopped the crestor and only the leg cramps stopped. Tylenol and baclofen did not help. Went to ER for pain and was given IV dilaudid and toradol which helped at the time. She was rx norco. She tried 2 tabs at a time and threw up. She is just takin g1 tab q4 hrs now which helps with the body aches but not the headache. She could hardly walk and get out of bed due to the pain. Labs unremarkable. Patient also has intolerances to atorvastatin and rosuvastatin with  history of muscle cramps.
Age: 74.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Basophil count decreased, Basophil percentage, Bilirubin conjugated, Bilirubin urine, Blood albumin normal
Clinical narrative: patient received COVID-19 vaccine on 3/8 with symptoms starting on 3/12. patient complains of excruciating pain all over the body and headache. Stopped the crestor and only the leg cramps stopped. Tylenol and baclofen did not help. Went to ER for pain and was given IV dilaudid and toradol which helped at the time. She was rx norco. She tried 2 tabs at a time and threw up. She is just takin g1 tab q4 hrs now which helps with the body aches but not the headache. She could hardly walk and get out of bed due to the pain. Labs unremarkable. Patient also has intolerances to atorvastatin and rosuvastatin with  history of muscle cramps.
Age: 74.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Blood bilirubin, Blood calcium normal, Blood chloride normal, Blood creatine phosphokinase decreased, Blood creatinine normal
Clinical narrative: patient received COVID-19 vaccine on 3/8 with symptoms starting on 3/12. patient complains of excruciating pain all over the body and headache. Stopped the crestor and only the leg cramps stopped. Tylenol and baclofen did not help. Went to ER for pain and was given IV dilaudid and toradol which helped at the time. She was rx norco. She tried 2 tabs at a time and threw up. She is just takin g1 tab q4 hrs now which helps with the body aches but not the headache. She could hardly walk and get out of bed due to the pain. Labs unremarkable. Patient also has intolerances to atorvastatin and rosuvastatin with  history of muscle cramps.
Age: 74.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Blood glucose increased, Blood potassium normal, Blood sodium normal, Blood urea decreased, Carbon dioxide decreased
Clinical narrative: patient received COVID-19 vaccine on 3/8 with symptoms starting on 3/12. patient complains of excruciating pain all over the body and headache. Stopped the crestor and only the leg cramps stopped. Tylenol and baclofen did not help. Went to ER for pain and was given IV dilaudid and toradol which helped at the time. She was rx norco. She tried 2 tabs at a time and threw up. She is just takin g1 tab q4 hrs now which helps with the body aches but not the headache. She could hardly walk and get out of bed due to the pain. Labs unremarkable. Patient also has intolerances to atorvastatin and rosuvastatin with  history of muscle cramps.
Age: 74.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Eosinophil count normal, Eosinophil percentage, Globulins increased, Glomerular filtration rate normal, Glucose urine absent
Clinical narrative: patient received COVID-19 vaccine on 3/8 with symptoms starting on 3/12. patient complains of excruciating pain all over the body and headache. Stopped the crestor and only the leg cramps stopped. Tylenol and baclofen did not help. Went to ER for pain and was given IV dilaudid and toradol which helped at the time. She was rx norco. She tried 2 tabs at a time and threw up. She is just takin g1 tab q4 hrs now which helps with the body aches but not the headache. She could hardly walk and get out of bed due to the pain. Labs unremarkable. Patient also has intolerances to atorvastatin and rosuvastatin with  history of muscle cramps.
Age: 74.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Haematocrit decreased, Haemoglobin decreased, Haemoglobin urine present, Headache, Immature granulocyte count
Clinical narrative: patient received COVID-19 vaccine on 3/8 with symptoms starting on 3/12. patient complains of excruciating pain all over the body and headache. Stopped the crestor and only the leg cramps stopped. Tylenol and baclofen did not help. Went to ER for pain and was given IV dilaudid and toradol which helped at the time. She was rx norco. She tried 2 tabs at a time and threw up. She is just takin g1 tab q4 hrs now which helps with the body aches but not the headache. She could hardly walk and get out of bed due to the pain. Labs unremarkable. Patient also has intolerances to atorvastatin and rosuvastatin with  history of muscle cramps.
Age: 74.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Influenza A virus test negative, Influenza B virus test, Lipase normal, Lymphocyte count decreased, Lymphocyte percentage
Clinical narrative: patient received COVID-19 vaccine on 3/8 with symptoms starting on 3/12. patient complains of excruciating pain all over the body and headache. Stopped the crestor and only the leg cramps stopped. Tylenol and baclofen did not help. Went to ER for pain and was given IV dilaudid and toradol which helped at the time. She was rx norco. She tried 2 tabs at a time and threw up. She is just takin g1 tab q4 hrs now which helps with the body aches but not the headache. She could hardly walk and get out of bed due to the pain. Labs unremarkable. Patient also has intolerances to atorvastatin and rosuvastatin with  history of muscle cramps.
Age: 74.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Mean cell haemoglobin concentration decreased, Mean cell haemoglobin normal, Mean cell volume normal, Monocyte count normal, Monocyte percentage
Clinical narrative: patient received COVID-19 vaccine on 3/8 with symptoms starting on 3/12. patient complains of excruciating pain all over the body and headache. Stopped the crestor and only the leg cramps stopped. Tylenol and baclofen did not help. Went to ER for pain and was given IV dilaudid and toradol which helped at the time. She was rx norco. She tried 2 tabs at a time and threw up. She is just takin g1 tab q4 hrs now which helps with the body aches but not the headache. She could hardly walk and get out of bed due to the pain. Labs unremarkable. Patient also has intolerances to atorvastatin and rosuvastatin with  history of muscle cramps.
Age: 74.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Muscle spasms, Neutrophil count decreased, Neutrophil percentage, Nitrite urine absent, Pain
Clinical narrative: patient received COVID-19 vaccine on 3/8 with symptoms starting on 3/12. patient complains of excruciating pain all over the body and headache. Stopped the crestor and only the leg cramps stopped. Tylenol and baclofen did not help. Went to ER for pain and was given IV dilaudid and toradol which helped at the time. She was rx norco. She tried 2 tabs at a time and threw up. She is just takin g1 tab q4 hrs now which helps with the body aches but not the headache. She could hardly walk and get out of bed due to the pain. Labs unremarkable. Patient also has intolerances to atorvastatin and rosuvastatin with  history of muscle cramps.
Age: 74.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Platelet count normal, Protein total normal, Protein urine absent, Red blood cell count decreased, Red blood cells urine
Clinical narrative: patient received COVID-19 vaccine on 3/8 with symptoms starting on 3/12. patient complains of excruciating pain all over the body and headache. Stopped the crestor and only the leg cramps stopped. Tylenol and baclofen did not help. Went to ER for pain and was given IV dilaudid and toradol which helped at the time. She was rx norco. She tried 2 tabs at a time and threw up. She is just takin g1 tab q4 hrs now which helps with the body aches but not the headache. She could hardly walk and get out of bed due to the pain. Labs unremarkable. Patient also has intolerances to atorvastatin and rosuvastatin with  history of muscle cramps.
Age: 74.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Red cell distribution width normal, SARS-CoV-2 test negative, Specific gravity urine normal, Troponin T normal, Urinary casts
Clinical narrative: patient received COVID-19 vaccine on 3/8 with symptoms starting on 3/12. patient complains of excruciating pain all over the body and headache. Stopped the crestor and only the leg cramps stopped. Tylenol and baclofen did not help. Went to ER for pain and was given IV dilaudid and toradol which helped at the time. She was rx norco. She tried 2 tabs at a time and threw up. She is just takin g1 tab q4 hrs now which helps with the body aches but not the headache. She could hardly walk and get out of bed due to the pain. Labs unremarkable. Patient also has intolerances to atorvastatin and rosuvastatin with  history of muscle cramps.
Age: 74.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Urine ketone body absent, Urine leukocyte esterase, Urobilinogen urine, Vomiting, White blood cell count decreased
Clinical narrative: patient received COVID-19 vaccine on 3/8 with symptoms starting on 3/12. patient complains of excruciating pain all over the body and headache. Stopped the crestor and only the leg cramps stopped. Tylenol and baclofen did not help. Went to ER for pain and was given IV dilaudid and toradol which helped at the time. She was rx norco. She tried 2 tabs at a time and threw up. She is just takin g1 tab q4 hrs now which helps with the body aches but not the headache. She could hardly walk and get out of bed due to the pain. Labs unremarkable. Patient also has intolerances to atorvastatin and rosuvastatin with  history of muscle cramps.
Age: 74.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: White blood cells urine positive, pH urine normal
Clinical narrative: patient received COVID-19 vaccine on 3/8 with symptoms starting on 3/12. patient complains of excruciating pain all over the body and headache. Stopped the crestor and only the leg cramps stopped. Tylenol and baclofen did not help. Went to ER for pain and was given IV dilaudid and toradol which helped at the time. She was rx norco. She tried 2 tabs at a time and threw up. She is just takin g1 tab q4 hrs now which helps with the body aches but not the headache. She could hardly walk and get out of bed due to the pain. Labs unremarkable. Patient also has intolerances to atorvastatin and rosuvastatin with  history of muscle cramps.
Age: 74.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Headache, Laboratory test, Mobility decreased, Muscle spasms, Pain
Clinical narrative: patient received COVID-19 vaccine on 3/8 with symptoms starting on 3/12. patient complains of excruciating pain all over the body and headache. Stopped the crestor and only the leg cramps stopped. Tylenol and baclofen did not help. Went to ER for pain and was given IV dilaudid and toradol which helped at the time. She was rx norco. She tried 2 tabs at a time and threw up. She is just takin g1 tab q4 hrs now which helps with the body aches but not the headache. She could hardly walk and get out of bed due to the pain. Labs unremarkable. Patient also has intolerances to atorvastatin and rosuvastatin with  history of muscle cramps.
Age: 74.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Vomiting
Clinical narrative: patient received COVID-19 vaccine on 3/8 with symptoms starting on 3/12. patient complains of excruciating pain all over the body and headache. Stopped the crestor and only the leg cramps stopped. Tylenol and baclofen did not help. Went to ER for pain and was given IV dilaudid and toradol which helped at the time. She was rx norco. She tried 2 tabs at a time and threw up. She is just takin g1 tab q4 hrs now which helps with the body aches but not the headache. She could hardly walk and get out of bed due to the pain. Labs unremarkable. Patient also has intolerances to atorvastatin and rosuvastatin with  history of muscle cramps.
Sex: F
Vaccine: PPV
Symptoms: Hypersensitivity
Clinical narrative: had an allergic reaction to the "pneumonia vaccine" manufactured by Merck; This spontaneous report as received from a currently 80-year-old female patient via Pfizer, referring to herself, who was scheduled to receive her first dose of the Pfizer-BioNTech COVID-19 vaccine next Monday. The patient's concurrent condition, concomitant medication and medical history were not reported.   On an unknown date, the patient was vaccinated with pneumococcal vaccine, polyvalent (23-valent) (PNEUMOVAX23) (strength, dose, frequency, route of administration, indication, batch/lot# and expiration date were not reported) for prophylaxis. The patient had an allergic reaction to pneumococcal vaccine, polyvalent (23-valent) (PNEUMOVAX23). The outcome of the event was unknown. The event was related to pneumococcal vaccine, polyvalent (23-valent) (PNEUMOVAX23).
Sex: U
Vaccine: MMR
Symptoms: Product storage error
Clinical narrative: No further AE; multiple improperly stored doses of MMR-II vaccines were administered; This spontaneous report was received from a nurse referring to a patient of unknown age and gender. The patient's pertinent medical history, concomitant drugs and drug allergies/reactions were not reported    On 09-FEB-2021, the patient was vaccinated with measles, mumps, and rubella (wistar ra 27-3) virus vaccine, live albumin status recombinant Human albumin (rHA) (M-M-R II) (lot # S037503, expiration date was 20-NOV-2021, route and strength were not provided) 1 injection for prophylaxis.   Temperature excursion of this vaccine was 48.7 Fahrenheit for 1 hour and 10 minutes without any previous temperature excursion. The digital data logger was involved. No further adverse event was reported.
Age: 3.0
Sex: U
Vaccine: RV5
Symptoms: Product administered to patient of inappropriate age
Clinical narrative: ROTATEQ was administered via NG tube; patient was 3 years old; uncertain if product was administered to patient; No additional AE/PQC reported; This spontaneous report was received from a pharmacist referring to a 3-year-old patient of unknown gender with nasogastric tube (NG tube) insertion. The patient's medical history, concomitant drugs and drug allergies/reactions were not reported.  On an unknown date, the patient was vaccinated with rotavirus vaccine, live, oral, pentavalent (ROTATEQ) (lot #, expiration date, dose and strength were not reported) via NG tube for prophylaxis (incorrect route of product administration; product administered to patient of inappropriate age).       The reporter inquired if rotavirus vaccine, live, oral, pentavalent (ROTATEQ) could be administered via NG tube and what was the oldest possible age that a patient could receive it. The reporter was also uncertain if this vaccine was administered to patient (circumstance or information capable of leading to medication error). No additional adverse event was reported.
Age: 44.0
Sex: U
Vaccine: HEPA
Symptoms: Expired product administered, Product storage error
Clinical narrative: No additional AE information was available.; Caller reporting AE for expired product (VAQTA) administered 3 times with previous temperature excursion.; Caller reporting AE for expired product (VAQTA) administered 3 times with previous temperature excursion.; This spontaneous report was received from a medical assistant referring to a 44 year old patient of unknown gender. Information regarding the patient's pertinent medical history, concurrent conditions, concomitant therapies and previous drug reactions or allergies was not provided.  On 21-JAN-2021, the patient was vaccinated with an expired dose of hepatitis a vaccine, inactivated (VAQTA) at a dose of 1.0 milliliter (mL) as prophylaxis (strength, vaccination scheme frequency, route of administration, and anatomical site of vaccination were not reported; lot number S034296, has been verified to be a valid lot number for hepatitis a vaccine, inactivated (VAQTA) prefilled syringe, expiration date reported and established as 09-JAN-2021) (expired product administered). Additionally, it was reported that the vaccine was administered with previous temperature excursions (product storage error). No adverse events were reported.  This is one of several reports received from the same reporter. combinationproductreport: Yes; brandname: VAQTA SYRINGE (DEVICE); commondevicename: Hepatitis A Vaccine, Inactivated; productcode: FMF; devicetype: SYRINGE, PISTON (FMF); manufacturername: Merck Sharp & Dohme Corp.; devicelotnumber: S034296; expirationdate: 09-JAN-2021; deviceage and unit: 0 ; malfunction: Unknown; deviceusage: Initial; reasonfornoneval: 81 Other; labeledsingleusedevice: No; mdcpreportability: No; mdcpreprationale: Case information does not meet the criteria for Reportability; Sender's Comments:  US-009507513-2103USA001891:
Sex: M
Vaccine: HEPA
Symptoms: Incorrect dose administered, Underdose
Clinical narrative: no adverse event; Incorrect dose administered; accidental underdose; This spontaneous report as received from a nurse refers to a 19 year old male patient.     The patient's concurrent conditions, medical history and concomitant medications were not provided.  On 05-MAR-2021, the patient was inadvertently vaccinated with a 0.5 mL pediatric dose of hepatitis a vaccine, inactivated (VAQTA) lot # T020442 with expiration date of 26-JAN-2022, instead of a 1 mL adult, for prophylaxis (route of administration was not provided) (accidental underdose and incorrect dose administered). Caller reported no additional adverse event (AE) or product quality complaint (PQC) at time of call.
Sex: U
Vaccine: HPV9
Symptoms: Product storage error
Clinical narrative: Patient received GARDASIL 9 that underwent an unevaluated temperture excursion; This spontaneous report was received from a medical assistant, concerning a patient of unknown age and gender. No information was provided regarding the patient's pertinent medical history, concomitant medications and previous drug reactions or allergies.  On 03-MAR-2021, the patient was vaccinated with hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast) (GARDASIL 9), at a dose of 0.5 milliliter (ml) (lot number S028738, which was verified to be a valid lot number, expiration date reported and upon internal validation established as 03-APR-2022) (frequency, route of administration, anatomical location and vaccination scheme were not reported), as prophylaxis. The administered dose underwent an unevaluated temperature excursion of 35.8 Fahrenheit (F) during a time frame of 14 hours and 0 minutes, as recorded by data logger (product storage error).  "This is one of several reports received from the same reporter." combinationproductreport: Yes; brandname: GARDASIL 9 SYRINGE (DEVICE); commondevicename: HPV rL1 6 11 16 18 31 33 45 52 58 VLP vaccine (yeast); productcode: FMF; devicetype: SYRINGE, PISTON (FMF); manufacturername: devicelotnumber: S028738; expirationdate: 03-APR-2022; deviceage and unit: 0 ; malfunction: Unknown; deviceusage: Initial; reasonfornoneval: 81 Other; labeledsingleusedevice: No; mdcpreportability: No; mdcpreprationale: Case information does not meet the criteria for Reportability; Sender's Comments:  US-009507513-2103USA002153:
Sex: U
Vaccine: VARCEL
Symptoms: Product storage error
Clinical narrative: No other AE.; temperature excursion; This spontaneous report was received from a registered nurse and refers to a patient of unknown age. There was no information about the patient's concurrent conditions, concomitant therapies or medical history provided. On an unknown date, the patient was vaccinated with one dose of improperly stored varicella virus vaccine live (oka/merck)(VARIVAX) lot # S038178, expiration date: 26-NOV-2021 (formulation, strength, dose, frequency, route of administration were not reported) for prophylaxis. On an unknown date, the dose of the vaccine was exposed to temperature excursion at -14.5 Celsius degrees (C) for 1 hour 56 minutes. There was no previous temperature excursion reported. The call was due to digital data logger. No additional adverse event was reported.
Sex: U
Vaccine: PPV
Symptoms: Syringe issue
Clinical narrative: No additional AEs; Pharmacist states the product leaked out where the syringe meets the needle during administration.; Pharmacist states the product leaked out where the syringe meets the needle during administration.; This spontaneous report was received from a pharmacist referring to a patient of unknown age and gender. Information regarding the patient's pertinent medical history, concurrent conditions, concomitant therapies, and previous drug reactions or allergies was not provided.  On 05-MAR-2021, the patient was vaccinated with one dose of 0.5 milliliters (ml) of pneumococcal vaccine, polyvalent (23-valent) (PNEUMOVAX 23) injection as prophylaxis (vaccination scheme frequency, route of administration, and anatomical location were not reported; lot number reported as T020639, has been verified to be a valid lot number pneumococcal vaccine, polyvalent (23-valent) (PNEUMOVAX 23) prefilled syringe, expiration date reported and validated as 13-MAR-2022). It was reported that during the administration. According to the pharmacist, the product leaked out where the syringe meets the needle during the vaccine administration (device leakage and poor quality device used). No adverse events were reported. combinationproductreport: Yes; brandname: PNEUMOVAX23 SYRINGE (DEVICE); commondevicename: Pneumococcal Vaccine, Polyvalent (23-valent); productcode: FMF; devicetype: SYRINGE, PISTON (FMF); manufacturername: Merck Sharp & Dohme Corp.; devicelotnumber: T020639; expirationdate: 13-MAR-2022; deviceage and unit: 0 ; malfunction: Unknown; deviceusage: Initial; reasonfornoneval: 81 Other; labeledsingleusedevice: No; mdcpreportability: No; mdcpreprationale: Case information does not meet the criteria for Reportability
Age: 1.17
Sex: U
Vaccine: MMR
Symptoms: Incorrect route of product administration
Clinical narrative: administered MMRlI intramuscularly; The customer did not report any other adverse event; This spontaneous report as received from a consumer concerning to a 14-month old patient of unknown gender.      The patient's concurrent conditions, medical history, allergies or drug reactions, and concomitant medications were not provided.  On an unknown date, the patient was vaccinated with the first dose of measles, mumps, and rubella (wistar ra 27-3) virus vaccine, live (M-M-R II), intramuscularly (dose, frequency, lot# and expiration date were not provided). The reporter did not inform any other adverse event.
Sex: U
Vaccine: VARZOS
Symptoms: Herpes zoster
Clinical narrative: shingles; other zoster-related conditions; Information has been received from a lawyer and a patient (pt) of unknown age and gender regarding a case in litigation. Information about concurrent condition, medical history and concomitant medication was not reported. On or about 17-MAR-2015, the pt was vaccinated with zoster vaccine live (ZOSTAVAX) (dose, lot#, expiration date and route were not reported) for the long-term prevention of shingles and zoster-related conditions. Subsequent to the inoculation (date not reported), the pt was treated by a physician for shingles and other zoster-related conditions. As a direct and proximate result of zoster vaccine live (ZOSTAVAX), the pt has and will continue suffer ongoing injuries, including but not limited to: mental and physical pain and suffering; medical care and treatment for these injuries; significant medical and related expenses as a result of these injuries, including but not limited to medical losses and costs include care for hospitalization, physician care, monitoring, treatment, medications, and supplies; diminished capacity for the enjoyment of life; diminished quality of life; increased risk of premature death, aggravation of preexisting conditions and activation of latent conditions; and other losses and damages; and will continue to suffer such losses, and damages in the future. The outcome of the events was considered as not recovered. Causality between the events and zoster vaccine live (ZOSTAVAX) was related.
Age: 61.0
Sex: F
Vaccine: VARZOS
Symptoms: Cardiac failure congestive
Clinical narrative: Congestive Heart Failure; zoster-related conditions; This initial spontaneous report was received from a lawyer regarding a case in litigation and refers to a currently approximately 69-year-old female patient. No information was provided regarding medical history, concurrent conditions, or concomitant medications. On or about 11-JUN-2013, the patient was administered the zoster vaccine live (ZOSTAVAX) vaccine (dose, route of administration, anatomical location, lot # and expiration date were not specified), by a pharmacist at the pharmacy, for the long-term prevention of shingles and zoster-related conditions. Subsequently, on an unspecified date, the patient was treated by a physician for the following injuries resulting from the patient's zoster vaccine live (ZOSTAVAX) use: congestive heart failure and zoster-related conditions. The outcome of the events was not reported. The reporter considered the events to be related to zoster vaccine live (ZOSTAVAX).  Upon internal review, the event of congestive heart failure was determined to be medically significant.
Age: 70.0
Sex: U
Vaccine: VARZOS
Symptoms: Autoimmune disorder, Balance disorder, Blindness unilateral, Deafness, Thyroid disorder
Clinical narrative: loss of vision in left eye; loss of hearing; autoimmune disease; vision issues; balance issues; thyroid issues; This initial spontaneous report was received from a lawyer regarding a case in litigation and refers to a currently approximately 77-year-old patient of unknown gender. No information was provided regarding medical history, concurrent conditions, or concomitant medications. On or about 20-NOV-2014, the patient was administered the zoster vaccine live (ZOSTAVAX) (dose, route of administration, anatomical location, lot # and expiration date were not specified) at county health department for the long-term prevention of shingles and zoster-related conditions. Subsequently, on an unspecified date, the patient was treated by providers for the following injuries resulting from the patient's zoster vaccine live (ZOSTAVAX) use: loss of vision in left eye, vision issues, loss of hearing, balance issues, thyroid issues and autoimmune disease. The outcomes of all the events were not reported. The reporter considered all the events to be related to zoster vaccine live (ZOSTAVAX).   Upon internal review, the events of loss of vision in left eye, loss of hearing and autoimmune disease were determined to be medically significant.
Age: 70.0
Sex: U
Vaccine: VARZOS
Symptoms: Visual impairment
Clinical narrative: loss of vision in left eye; loss of hearing; autoimmune disease; vision issues; balance issues; thyroid issues; This initial spontaneous report was received from a lawyer regarding a case in litigation and refers to a currently approximately 77-year-old patient of unknown gender. No information was provided regarding medical history, concurrent conditions, or concomitant medications. On or about 20-NOV-2014, the patient was administered the zoster vaccine live (ZOSTAVAX) (dose, route of administration, anatomical location, lot # and expiration date were not specified) at county health department for the long-term prevention of shingles and zoster-related conditions. Subsequently, on an unspecified date, the patient was treated by providers for the following injuries resulting from the patient's zoster vaccine live (ZOSTAVAX) use: loss of vision in left eye, vision issues, loss of hearing, balance issues, thyroid issues and autoimmune disease. The outcomes of all the events were not reported. The reporter considered all the events to be related to zoster vaccine live (ZOSTAVAX).   Upon internal review, the events of loss of vision in left eye, loss of hearing and autoimmune disease were determined to be medically significant.
Sex: U
Vaccine: MMR
Symptoms: Incorrect route of product administration
Clinical narrative: No other AE reported; We inadvertently gave an MMR II intramuscularly today instead of subcutaneous; This spontaneous report as received from a nurse via a company representative refers to a patient of unknown age and gender. Pertinent medical history, drug reactions, allergies and concomitant medications were not reported.  On 16-MAR-2021, the patient was inadvertently vaccinated with a dose of measles, mumps, and rubella (wistar ra 27-3) virus vaccine, live (M-M-R II) injection (lot number: S022754, expiration date: 22-JUL-2021) 0.5 ml intramuscularly (inappropriate route of vaccination). No adverse event was reported.
Age: 15.0
Sex: M
Vaccine: HPV9
Symptoms: Incomplete course of vaccination, No adverse event
Clinical narrative: No additional AE reported; received first dose at another facility when they were 15 years old in September 2018/now 18 years old and did not complete the series; This spontaneous report has been received from a registered nurse referring to a 15 years old male patient and his twin brother. No information was provided regarding the patient's medical history, concurrent conditions, drug and allergy history or concomitant medications.  On an unknown date in September 2018, the patient received the first dose of hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast)(GARDASIL 9) (strength, dose, frequency, lot# and expiration date were not provided) for prophylaxis.  The reporter stated that at the reporting time, the boy was 18 years old and had not complete the series and missed the second and third dose of hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast)(GARDASIL 9)(inappropriate schedule of product administration). No additional adverse events were reported.       This is one of two reports from the same reporter (#2103USA000715, twin brother case).; Sender's Comments:  US-009507513-2103USA000715:
Sex: U
Vaccine: VARZOS
Symptoms: Dehydration, Hypotension
Clinical narrative: hypotension; dehydration; This case was reported by a consumer via other manufacturer and described the occurrence of hypotension in a adult patient who received Herpes zoster (Shingrix) for prophylaxis.   On an unknown date, the patient received Shingrix. On an unknown date, 12 hrs after receiving Shingrix, the patient experienced hypotension and dehydration. On an unknown date, the outcome of the hypotension and dehydration were unknown.   It was unknown if the reporter considered the hypotension and dehydration to be related to Shingrix.  Additional details were provided as follows: The patient was reporter's family menber . The age at vaccination was not reported. The age group of the patient was not reported but selected as an adult as per vaccine indication. The patient had hypotension and dehydration 12 hours after vaccination. The reporter asked if the patient should get COVID vaccine or not.
Sex: F
Vaccine: VARZOS
Symptoms: Pain
Clinical narrative: Pain was similar to what she experienced in the past after / a shingles shot; This case was reported by a consumer via other manufacturer and described the occurrence of pain in a female 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 pain. On an unknown date, the outcome of the pain was unknown.   It was unknown if the reporter considered the pain to be related to Shingles vaccine.  Additional details were reported as follows: The age at vaccination was not reported. The patient experienced pain after Shingles shot which was simlar to the pain experienced by patient after receiving Covid-19 (manufacture Pfizer BioNT)  vaccine 2 weeks before the time of reporting . The information regarding consent to follow up was not reported. The patient received flu vaccine and experienced adverse event for tolerance see case US2021AMR027799; Sender's Comments:  US-GLAXOSMITHKLINE-US2021AMR027799:Same reporter.
Sex: U
Vaccine: VARZOS
Symptoms: Anxiety, Incomplete course of vaccination
Clinical narrative: Frightening reaction; This case was reported by a consumer and described the occurrence of anxiety reaction in a 78-year-old patient who received Herpes zoster (Shingrix) for prophylaxis.   In August 2020, the patient received the 1st dose of Shingrix. On an unknown date, less than 9 months after receiving Shingrix, the patient experienced anxiety reaction. On an unknown date, the outcome of the anxiety reaction was unknown.   It was unknown if the reporter considered the anxiety reaction to be related to Shingrix.  Additional details were provided as follows: The patient was reported for him/herself. The age at vaccination was not reporter. After receiving 1st dose Shingrix, the patient experienced frightening reaction. Till the time of reporting, the patient did not receive 2nd dose. The patient also wanted to know if he/she was safe to get Covid 19 vaccine. The start date of Shingrix was reported as 2000 which seems to be discrepant (potentially 2020). Clarification could not be obtained.
Sex: U
Vaccine: VARZOS
Symptoms: Therapeutic response unexpected
Clinical narrative: VACCINE HAS GOTTEN RID OF THEIR BLADDER INCONTIENCE / HELPED WITH NERVE DAMAGE; This case was reported by a consumer and described the occurrence of unexpected therapeutic effect in a patient who received Herpes zoster (Shingrix) for prophylaxis.   The patient's past medical history included shingles. Concurrent medical conditions included bladder incontinence and nerve damage (had from previous shingles).   In December 2020, the patient received Shingrix. On an unknown date, 1 week after receiving Shingrix, the patient experienced unexpected therapeutic effect. On an unknown date, the outcome of the unexpected therapeutic effect was unknown.   It was unknown if the reporter considered the unexpected therapeutic effect to be related to Shingrix.  Additional details were reported as follows: The age at vaccination was not applicable for this report. The reporter wanted to provide positive feedback for the Shingrix because the vaccine had got rid of their bladder incontinence and that previous never damage from shingles was going away. The reporter consented to follow up. The case had been linked with case US2021044025, reported by the same reporter. Note: It was unknown if the vaccine was administered to more than 1 patient hence case was conservatively kept as valid with unspecified number of patients. The clarification has been raised for the same (patient's quantity).; Sender's Comments:  US-GLAXOSMITHKLINE-US2021044025:same reporter, different patient (female)
Sex: F
Vaccine: VARZOS
Symptoms: Burning sensation, Insomnia, Pain, Post herpetic neuralgia
Clinical narrative: post herpetic pain all the time; it stings and burns all the time; cannot sleep; This case was reported by a consumer and described the occurrence of post zoster pain in a adult female patient who received Herpes zoster (Shingrix) for prophylaxis.   The patient's past medical history included shingles (in between the live vaccine and Shingrix patient had bad case of shingles). Previously administered products included shingles vaccine (received live shingles vaccine in 2012) and Shingrix with an associated reaction of post herpetic neuralgia (received 1st dose in 2017, refer case US2021048483).   On an unknown date, the patient received the 2nd dose of Shingrix. On an unknown date, less than 5 months after receiving Shingrix, the patient experienced post zoster pain, pain burning and sleeplessness. The patient was treated with lidocaine hydrochloride (Lidocaine Gel). Rechallenge with Shingrix was positive. On an unknown date, the outcome of the post zoster pain, pain burning and sleeplessness were unknown.   It was unknown if the reporter considered the post zoster pain, pain burning and sleeplessness to be related to Shingrix.  Additional details were provided as follows: The age at vaccination was not reported. In 2017, the patient received Shingrix and had post herpetic pain all the time, it stings and burns all the time and could not sleep.  The patient treated with lidocaine gel did not relieve pain.  The patient received 1st dose Shingrix and it boosted immune system but the second shot did not.  The reporter did not consent to follow up.  The lot and expiry not provided by caller.; Sender's Comments:  US-GLAXOSMITHKLINE-US2021048483:same reporter
Sex: U
Vaccine: VARZOS
Symptoms: Erythema, Vaccination complication
Clinical narrative: Had a reaction / Redness; This case was reported by a consumer and described the occurrence of erythema in a adult patient who received Herpes zoster (Shingrix) for prophylaxis.   On 9th February 2021, the patient received the 2nd dose of Shingrix. In February 2021, less than 2 weeks after receiving Shingrix, the patient experienced erythema. On an unknown date, the outcome of the erythema was not recovered/not resolved.   It was unknown if the reporter considered the erythema to be related to Shingrix.  Additional details were provided as follows: Age at vaccination was not reported. The patient had second Shingrix shot and had a reaction. The redness had almost cleared up but not completely.  The patient wanted to know how long should wait before getting a covid vaccination?
Sex: M
Vaccine: VARZOS
Symptoms: Nodule, Swelling
Clinical narrative: Large knot on arm for approximately 3 weeks; This case was reported by a nurse via sales rep and described the occurrence of local swelling in a adult male patient who received Herpes zoster (Shingrix) for prophylaxis.   On an unknown date, the patient received the 1st dose of Shingrix. On an unknown date, unknown after receiving Shingrix, the patient experienced local swelling. On an unknown date, the outcome of the local swelling was recovered/resolved.   It was unknown if the reporter considered the local swelling to be related to Shingrix.  Additional details were provided as follows: Age at vaccination was not reported. The reporter reported that the patient had large knot on arm  after  the administration of first dose of Shingrix which lasted for approximately 3 weeks. The reporter consented to follow up.
Age: 79.0
Sex: M
Vaccine: VARZOS
Symptoms: Arthralgia, Fatigue, Hypoaesthesia, Pain in extremity
Clinical narrative: stabbing pain in his left arm /  arm pain lasted a week to a week and a half; numbness in his left ring and pinky fingers / numbness lasted 2.5 to 3 weeks; fatigued /  fatigue lasted all week; This case was reported by a consumer via call center representative and described the occurrence of pain in arm in a 79-year-old male patient who received Herpes zoster (Shingrix) for prophylaxis.   Concomitant products included Herpes zoster (Shingrix).   On 24th January 2021, the patient received the 2nd dose of Shingrix. In January 2021, less than a day after receiving Shingrix and an unknown time after receiving Shingrix, the patient experienced pain in arm, numbness in fingers and fatigue. On 29th January 2021, the outcome of the fatigue was recovered/resolved. On an unknown date, the outcome of the pain in arm and numbness in fingers were recovered/resolved.   It was unknown if the reporter considered the pain in arm, numbness in fingers and fatigue to be related to Shingrix.  Additional details were reported as follows: The reporter is the patient's wife.  The patient received his first dose in the week of November 25th 2020 in the left arm. He had a very sore left shoulder for a week following that dose (for tolerance refer US2021053253). He received his second dose on Sunday 24th January 2021 also in the left arm and 5-6 hours after administration he had a stabbing pain in his left arm and numbness in his left ring and pinky fingers. The arm pain lasted a week to a week and a half. The numbness lasted 2.5 to 3 weeks. He was fatigued and slept all day Monday. The fatigue lasted all week and was better by Thursday and resolved by Friday. Did not consent to follow-up.; Sender's Comments:  US-GLAXOSMITHKLINE-US2021053253:same reporter (husband´s case) US-GLAXOSMITHKLINE-US2021AMR053770:Same reporter US-GLAXOSMITHKLINE-US2021053271:same patient, same reporter, 2nd dose
Sex: U
Vaccine: VARZOS
Symptoms: Incomplete course of vaccination, Pain, Pain in extremity
Clinical narrative: arm soreness; pain; This case was reported by a consumer via call center representative and described the occurrence of pain in arm in a adult patient who received Herpes zoster (Shingrix) for prophylaxis.   On an unknown date, the patient received the 1st dose of Shingrix. On an unknown date, unknown after receiving Shingrix, the patient experienced pain in arm and pain. Shingrix was discontinued. On an unknown date, the outcome of the pain in arm and pain were unknown.   It was unknown if the reporter considered the pain in arm and pain to be related to Shingrix.  Additional details were provided as follows: The age was not reported but capture as an adult as per vaccine indication. The reporter reported that he knows 5 different people who did not got second dose of shingrix due to arm soreness and pain. He also reported that one patient was at the clinic but had no information about that patient. The reporter consented to follow up. This is 1 of 5 cases reported by the same reporter.; Sender's Comments:  US-GLAXOSMITHKLINE-US2021054377:same reporter US-GLAXOSMITHKLINE-US2021AMR055619:Original Case : US2021054379 US-GLAXOSMITHKLINE-US2021AMR055620:Original Case : US2021054379 US-GLAXOSMITHKLINE-US2021AMR055618:Original Case : US2021054379
Sex: U
Vaccine: MEN
Symptoms: Erythema, Feeling hot
Clinical narrative: my arm has been red and hot; my arm has been red and hot; This case was reported by a consumer via interactive digital media and described the occurrence of erythema of extremities in a patient who received Men B NVS (Meningococcal B vaccine) for prophylaxis.   On an unknown date, the patient received Meningococcal B vaccine. On an unknown date, 5 days after receiving Meningococcal B vaccine, the patient experienced erythema of extremities and extremities hot feeling of. On an unknown date, the outcome of the erythema of extremities and extremities hot feeling of were unknown.   It was unknown if the reporter considered the erythema of extremities and extremities hot feeling of to be related to Meningococcal B vaccine.  Additional details were provided as follows: The patient reported case for himself or herself. The age at vaccination was not reported. The patient received meningitis b vaccine and after 5 days from receiving it patient experienced red arm and hot arm. No further information reported.
Sex: F
Vaccine: TDAP
Symptoms: Feeling abnormal, Headache, Pain, Pyrexia
Clinical narrative: Headache; Was achy; Fever; She reacts differently than other people; This case was reported by a consumer via call center representative and described the occurrence of headache in a 62-year-old female patient who received DTPa (Reduced antigen) (Tdap Vaccine) for prophylaxis.   The patient's past medical history included conjunctivitis. Concurrent medical conditions included pre-diabetic, allergy to animal dander and house dust mite allergy.   On an unknown date, the patient received Tdap Vaccine. On an unknown date, 1 day after receiving Tdap Vaccine, the patient experienced headache, pain, fever and feeling abnormal. On an unknown date, the outcome of the headache and pain were recovered/resolved and the outcome of the fever and feeling abnormal were unknown.   The reporter considered the headache and pain to be related to Tdap Vaccine. It was unknown if the reporter considered the fever and feeling abnormal to be related to Tdap Vaccine.  Additional details were provided as follows: The reporter was the patient. The patient was allergic to dust mites and pet dander. The age at vaccination was not reported. A number of years ago, the patient had received a tdap shot and had a little reaction the next day.  The patient had every symptom and mentioned she had headache and that she was achy. The second day after receiving the tdap vaccine, the patient had fever, achy and she reacted differently than other people.  The patient was not asked regarding the name of the vaccine and MD contact information. This case has been linked to US2021059714 and US2021AMR060203, reported by the same reporter while the linked case US2021AMR061311 has been invalidated from the database.; Sender's Comments:  US-GLAXOSMITHKLINE-US2021AMR060203:Same reporter, Tdap vaccine US-GLAXOSMITHKLINE-US2021AMR061311:Same reporter. Invalid - case.