chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 37.0
Sex: F
Vaccine: COVID19, COVID19, COVID19
Symptoms: Body temperature, Burning sensation, Erythema, Feeling hot, Flushing
Clinical narrative: The last 4 months have been the most difficult phase of my life.  I started facing the below symptoms after nearly 10-15 days of receiving  1st covid shot.   Some parts of my body burn for several hours every day, feel warm throughout the day, almost as if smoke comes out of my ears,  get a red rash, sometimes followed by low-grade fever (99 degrees).   I feel extremely warm throughout the day and night (almost feeling of burns, hot flashes is an understatement. These are burns occurring throughout the day and night and sometimes smoke coming out of the ear). A lot of times my ears, arms, neck, and cheeks become blood red and I have done a series of tests to find out. All my tests are normal and they don't explain symptoms. In the last 4 months, I have got a lot of blood tests/urine tests done but none of them explain the symptoms.   I had sleepless nights because I am extremely warm. I switch on the AC throughout the day and night but still very warm. Is there a way, I can unvaccinated myself? I am unable to sleep at night.   So far, I was not sure what is causing this but since all my reports are normal. I now believe this is because of covid 1st shot. Let me know how you can help.   Thanks in advance!
Age: 37.0
Sex: F
Vaccine: COVID19, COVID19, COVID19
Symptoms: Hot flush, Insomnia, Laboratory test, Pyrexia, Rash erythematous
Clinical narrative: The last 4 months have been the most difficult phase of my life.  I started facing the below symptoms after nearly 10-15 days of receiving  1st covid shot.   Some parts of my body burn for several hours every day, feel warm throughout the day, almost as if smoke comes out of my ears,  get a red rash, sometimes followed by low-grade fever (99 degrees).   I feel extremely warm throughout the day and night (almost feeling of burns, hot flashes is an understatement. These are burns occurring throughout the day and night and sometimes smoke coming out of the ear). A lot of times my ears, arms, neck, and cheeks become blood red and I have done a series of tests to find out. All my tests are normal and they don't explain symptoms. In the last 4 months, I have got a lot of blood tests/urine tests done but none of them explain the symptoms.   I had sleepless nights because I am extremely warm. I switch on the AC throughout the day and night but still very warm. Is there a way, I can unvaccinated myself? I am unable to sleep at night.   So far, I was not sure what is causing this but since all my reports are normal. I now believe this is because of covid 1st shot. Let me know how you can help.   Thanks in advance!
Age: 37.0
Sex: F
Vaccine: COVID19, COVID19, COVID19
Symptoms: SARS-CoV-2 test
Clinical narrative: The last 4 months have been the most difficult phase of my life.  I started facing the below symptoms after nearly 10-15 days of receiving  1st covid shot.   Some parts of my body burn for several hours every day, feel warm throughout the day, almost as if smoke comes out of my ears,  get a red rash, sometimes followed by low-grade fever (99 degrees).   I feel extremely warm throughout the day and night (almost feeling of burns, hot flashes is an understatement. These are burns occurring throughout the day and night and sometimes smoke coming out of the ear). A lot of times my ears, arms, neck, and cheeks become blood red and I have done a series of tests to find out. All my tests are normal and they don't explain symptoms. In the last 4 months, I have got a lot of blood tests/urine tests done but none of them explain the symptoms.   I had sleepless nights because I am extremely warm. I switch on the AC throughout the day and night but still very warm. Is there a way, I can unvaccinated myself? I am unable to sleep at night.   So far, I was not sure what is causing this but since all my reports are normal. I now believe this is because of covid 1st shot. Let me know how you can help.   Thanks in advance!
Age: 77.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Capsular contracture associated with breast implant
Clinical narrative: right breast implant contracture 3 months after second covid 19 vaccine. no prior symptoms since initial implantation 30 years ago.
Age: 55.0
Sex: F
Vaccine: COVID19
Symptoms: Arthralgia, Feeling abnormal, Headache, Limb discomfort
Clinical narrative: Joint paint, limbs felt heavy, brain fog, headache.
Sex: F
Vaccine: COVID19, COVID19, COVID19
Symptoms: Chills, Dyspnoea, Nausea, Pyrexia
Clinical narrative: Fever, difficulty breathing, chills, nausea Eat 2 pieces of Tyleno
Age: 15.0
Sex: F
Vaccine: COVID19
Symptoms: Fatigue, Headache, Injection site pain, Injection site swelling, Myalgia
Clinical narrative: Pain and swelling at the injection site at the time of vaccine.  Swelling resolved after day 2. Pain and soreness in the arm currently unresolved.   Headache (intermittent) Muscle Pain (intermittent) and Fatigue (on-going) started on day 2 after vaccine. Adverse reactions currently unresolved.
Age: 15.0
Sex: F
Vaccine: COVID19
Symptoms: Pain in extremity
Clinical narrative: Pain and swelling at the injection site at the time of vaccine.  Swelling resolved after day 2. Pain and soreness in the arm currently unresolved.   Headache (intermittent) Muscle Pain (intermittent) and Fatigue (on-going) started on day 2 after vaccine. Adverse reactions currently unresolved.
Age: 43.0
Sex: M
Vaccine: COVID19
Symptoms: Chills, Feeling abnormal, Influenza like illness, Pain
Clinical narrative: Took J&J Vaccine Saturday Not allowed to get out of your car for five minutes because of potential sides. Not allowed to drive away for 20 minutes because of potential sides. 12 hours later, Saturday night, I'm driving along, and my body starts to shut down with chills, aches, and flu-like symptoms. Sunday evening, I'm just meh, and feel slightly better. Monday laying on the couch, not horrible but not great. Tuesday night rolls around, and I'm taken out yet again with 'flu-like symptoms. Wednesday, my flu-like symptoms hitting me hard.  Currently popping Asprin and Theraflu and am ready to call it a night yet again.
Age: 74.0
Sex: M
Vaccine: COVID19
Symptoms: Abdominal pain, Asthenia, Cognitive disorder, Fatigue, Hallucination
Clinical narrative: Abdominal pain for days, hallucinations, uncontrolled urination for days, fatigue, weakness, cognitive difficulties
Age: 74.0
Sex: M
Vaccine: COVID19
Symptoms: Urinary incontinence
Clinical narrative: Abdominal pain for days, hallucinations, uncontrolled urination for days, fatigue, weakness, cognitive difficulties
Age: 55.0
Sex: F
Vaccine: COVID19
Symptoms: Pruritus, Throat tightness, Tongue pruritus
Clinical narrative: About 20 min - 30 min after leaving I felt my throat getting very tight.  As tightness progressed, tongue started also getting itchy.  I could breath well despite tightness.  Face was also itchy as day went on but called Dr, took benadryl.
Age: 41.0
Sex: F
Vaccine: COVID19
Symptoms: Burning sensation, Chest discomfort, Enlarged uvula, Exposure during pregnancy, Eye pruritus
Clinical narrative: I began having itchy throat and eyes, them wheezing, tightness in chest, hives, my body felt like my insides were burning but I did not have a fever. It lasted for a few days and the only thing that helped me was taking Benadryl and Albuterol nebulizer treatments. My eyes were swollen and my uvula was swollen. My heart rate sustained in the 120s. I thought I was having a heart attack. I am 20 weeks pregnant and I am a COVID nurse.
Age: 41.0
Sex: F
Vaccine: COVID19
Symptoms: Eye swelling, Throat irritation, Urticaria, Wheezing
Clinical narrative: I began having itchy throat and eyes, them wheezing, tightness in chest, hives, my body felt like my insides were burning but I did not have a fever. It lasted for a few days and the only thing that helped me was taking Benadryl and Albuterol nebulizer treatments. My eyes were swollen and my uvula was swollen. My heart rate sustained in the 120s. I thought I was having a heart attack. I am 20 weeks pregnant and I am a COVID nurse.
Age: 53.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Chills, Fatigue, Headache, Injection site erythema, Injection site pain
Clinical narrative: swelling, redness, and pain at injection site fever headache tiredness muscle pain chills
Age: 53.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Injection site swelling, Myalgia, Pyrexia
Clinical narrative: swelling, redness, and pain at injection site fever headache tiredness muscle pain chills
Age: 43.0
Sex: M
Vaccine: COVID19
Symptoms: No adverse event
Clinical narrative: I had no issues.
Age: 54.0
Sex: M
Vaccine: COVID19
Symptoms: Abdominal pain, Ageusia, Hypophagia, Vomiting
Clinical narrative: My son nearly died from the vaccine, he suffered abdominal pain, and sever vomiting for 5 days, a he has only this evening had a mouthful of supper he has lost all taste,  he innoculation last Tuesday, so it's over a week he has had nothing to eat for fear of continues vomiting, we could not go to a doctor or the clinic as he was in to much pain to drive the car, so yesterday my sister brought him some medicine from the chemist, only started to feel a little bit better today, I nearly lost my son because of this bloody vaccine.
Age: 27.0
Sex: F
Vaccine: COVID19
Symptoms: Nausea
Clinical narrative: Nausea; This spontaneous case was reported by a consumer and describes the occurrence of NAUSEA (Nausea) in a 27-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     Gluten, latex, amitriptyline, prednisone.  Concurrent medical conditions included Drug allergy (Allergy to Amitriptyline), Drug allergy (Allergy to  prednisone), Drug allergy (Allergy of Gluten) and Latex allergy.    On 01-May-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form once. On 01-May-2021, the patient experienced NAUSEA (Nausea). On 10-May-2021, NAUSEA (Nausea) had resolved.            Concomitant product use was not provided.  Treatment for the event is IV fluids due to dehydration.
Age: 45.0
Sex: F
Vaccine: COVID19
Symptoms: Polymenorrhoea, SARS-CoV-2 test
Clinical narrative: Started menstrual cycle 3 weeks early; This spontaneous case was reported by a consumer and describes the occurrence of POLYMENORRHOEA (Started menstrual cycle 3 weeks early) in a 45-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 immunisation.     No Medical History information was reported.    On 03-Aug-2021 at 10:30 AM, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 10-Aug-2021 at 10:00 AM, the patient experienced POLYMENORRHOEA (Started menstrual cycle 3 weeks early). At the time of the report, POLYMENORRHOEA (Started menstrual cycle 3 weeks early) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 09-Aug-2021, SARS-CoV-2 test: positive (Positive) positive.     The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Concomitant medications were not reported. Treatment information was not provided.   Most recent FOLLOW-UP information incorporated above includes: On 13-Aug-2021: Follow up received on 13-AUG-2021 included contact information.
Age: 47.0
Sex: F
Vaccine: COVID19
Symptoms: Incorrect route of product administration, Injection site erythema, Injection site pruritus
Clinical narrative: Inappropriate route of vaccination; Iching of the injection spot and Redness about the size of a half dollar; Iching of the injection spot and Redness about the size of a half dollar/Redness after vaccination; This spontaneous case was reported by a consumer and describes the occurrence of INCORRECT ROUTE OF PRODUCT ADMINISTRATION (Inappropriate route of vaccination), INJECTION SITE PRURITUS (Iching of the injection spot and Redness about the size of a half dollar) and INJECTION SITE ERYTHEMA (Iching of the injection spot and Redness about the size of a half dollar/Redness after vaccination) in a 47-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     Concurrent medical conditions included Penicillin allergy.    On 06-Aug-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intravenous) 1 dosage form. On 06-Aug-2021, the patient experienced INCORRECT ROUTE OF PRODUCT ADMINISTRATION (Inappropriate route of vaccination), INJECTION SITE PRURITUS (Iching of the injection spot and Redness about the size of a half dollar) and INJECTION SITE ERYTHEMA (Iching of the injection spot and Redness about the size of a half dollar/Redness after vaccination). On 06-Aug-2021, INCORRECT ROUTE OF PRODUCT ADMINISTRATION (Inappropriate route of vaccination) had resolved. At the time of the report, INJECTION SITE PRURITUS (Iching of the injection spot and Redness about the size of a half dollar) and INJECTION SITE ERYTHEMA (Iching of the injection spot and Redness about the size of a half dollar/Redness after vaccination) had not resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intravenous) was unknown.       No concomitant medication was reported. No treatment medication was reported.   Most recent FOLLOW-UP information incorporated above includes: On 15-Aug-2021: Follow-up document received,  contains no new information.
Age: 54.0
Sex: F
Vaccine: COVID19
Symptoms: Cardiac disorder, Cardiac flutter, Chest pain, Incorrect route of product administration
Clinical narrative: Heart issue; Severe chest pain; Inappropriate route of vaccination; Heart fluttering; This spontaneous case was reported by a consumer and describes the occurrence of CARDIAC FLUTTER (Heart fluttering) in a 54-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 9LU-18343-69467) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     Concurrent medical conditions included Arrhythmia, Hypertension and Asthma.  On 29-Apr-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Subcutaneous) .5 milliliter. On 29-Apr-2021, the patient experienced CARDIAC FLUTTER (Heart fluttering) (seriousness criterion medically significant). On 30-Apr-2021, the patient experienced INCORRECT ROUTE OF PRODUCT ADMINISTRATION (Inappropriate route of vaccination). On an unknown date, the patient experienced CARDIAC DISORDER (Heart issue) and CHEST PAIN (Severe chest pain). The patient was treated with LORAZEPAM for Adverse event, at an unspecified dose and frequency. On 30-Apr-2021, CARDIAC FLUTTER (Heart fluttering) was resolving, INCORRECT ROUTE OF PRODUCT ADMINISTRATION (Inappropriate route of vaccination) had resolved. At the time of the report, CARDIAC DISORDER (Heart issue) and CHEST PAIN (Severe chest pain) outcome was unknown. Not Provided   mRNA-1273 (Moderna COVID-19 Vaccine) (Subcutaneous) dosing remained unchanged.  Concomitant product use was not provided by the reporter.  No treatment information was provided.  Company Comment - Based on the current available information and temporal association between the use of the product mRNA-1273 and the start date of the serious unexpected event of Cardiac flutter and non-serious events of Cardiac disorder and Chest pain, a causal relationship cannot be excluded; however case causality is confounded by the patient's known history of arrhythmia and hypertension. Causality for the event Incorrect route of product administration assessed as not applicable.   Most recent FOLLOW-UP information incorporated above includes: On 18-Aug-2021: Follow up received included new event added.; Sender's Comments: Based on the current available information and temporal association between the use of the product mRNA-1273 and the start date of the serious unexpected event of Cardiac flutter and non-serious events of Cardiac disorder and Chest pain, a causal relationship cannot be excluded; however case causality is confounded by the patient's known history of arrhythmia and hypertension. Causality for the event Incorrect route of product administration assessed as not applicable.
Age: 37.0
Sex: M
Vaccine: COVID19
Symptoms: Dizziness, Headache, Swelling
Clinical narrative: Swelling on the right side of my neck; Headache; dizziness; This is a spontaneous report from a contactable consumer, the patient. A 37-year-old male patient received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EW0164) via an unspecified route of administration in the left arm on 13Apr2021 at 12:00 (at the age of 37-years-old), as a single dose for COVID-19 immunisation. Medical history was reported as none. Concomitant medication were not reported. Prior to the vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. The patient did not receive any other vaccines within four weeks prior to the vaccination. The patient had no known allergies to medications, food or other products. On 15Apr2021 at 12:00, the patient experienced swelling on the right side of neck, headache and dizziness. The events did not result in doctor or other healthcare professional office/clinic visit, emergency room/department or urgent care. Therapeutic measures were not taken as a result of the events. The clinical outcome of the events swelling on the right side of neck, headache and dizziness was unknown at the time of reporting.   No follow-up attempts are needed. No further information is expected.
Sex: U
Vaccine: MMR, MMRV, VARCEL
Symptoms: No adverse event, Product administered to patient of inappropriate age, Wrong product administered
Clinical narrative: No additional adverse effects reported and; Caller who is a Nurse, inquiring about recommendation for PROQUAD that was inadvertently given to a coworker over the age limit according to PI.; The coworker was supposed to get MMR and V ARlV AX separately; This spontaneous report has been received from a nurse, referring to a patient of unknown age, who was 47 years old. Information about the patient's pertinent medical history, concurrent conditions concomitant medications and previous drug reactions and allergies was not provided.  On 27-JUL-2021, the patient was vaccinated inadvertently with measles, mumps, rubella and varicella (oka-merck) virus vaccine live (PROQUAD), at a dose of 0.5 milligram, lot number T032147 and expiration date on 20-MAR-2022  for prophylaxis (frequency, route of administration, anatomical location were not provided) to a coworker over the age limit according to the product information (product administered to patient of inappropriate age). The coworker was supposed to get Measles, Mumps, and Rubella (Wistar RA 27-3) Virus Vaccine, Live (M-M-R II) and varicella virus vaccine live (Oka/Merck) (VARIVAX) separately (wrong product administered). No additional adverse effects reported.
Age: 25.0
Sex: M
Vaccine: MMRV
Symptoms: No adverse event, Product administered to patient of inappropriate age, Product dispensing issue, Wrong product administered
Clinical narrative: No additional AE reported; a 25 year old patient was inadvertently administered a dose of PROQUAD; Patient was to receive mmr, but received mmrv; This spontaneous report was received from a nurse, referring to a 25-year-old male patient. Information regarding the patient's pertinent medical history, concurrent condition, drug reactions/allergies and concomitant medication was not provided.  On 29-JUN-2021, the patient was vaccinated inadvertently with measles, mumps, rubella and varicella (oka-merck) virus vaccine live(PROQUAD) (albumin status of rHA (recombinant Human albumin), 1 time dose, strength, vaccination scheme, route of administration were not provided, anatomical site of vaccination: right deltoid, lot # U002535, expiration date 24-JUL-2022, lot # T028139, expiration date 15-FEB-2022) for  prophylaxis instead of included measles, mumps, and rubella (wistar ra 27-3) virus vaccine, live(M-M-R II) (product administered to patient of inappropriate age and product dispensing issue). The patient was notified and reported no adverse event.
Age: 27.0
Sex: U
Vaccine: HPV9
Symptoms: Incomplete course of vaccination, No adverse event
Clinical narrative: No additional AE; had missed the 3rd GARDASIL 9 dose/had never received the 3rd GARDASIL 9 dose; This spontaneous report was received from a pharmacist, referring to a currently 28-year-old patient of unknown gender. Information regarding the patient's pertinent medical history, current condition, previous drug reaction or allergy and concomitant medication was not reported.  On an unknown date in July 2020 and in September on 2020, the patient was separately vaccinated with the first dose and second dose of hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast)(GARDASIL 9) (dose, strength, vaccination scheme, route of administration and anatomical site of vaccination were not reported, lot# and expiration date were not provided) for prophylaxis. The patient had missed the third dose of hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast)(GARDASIL 9) /had never received the third dose of hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast)(GARDASIL 9) as confirmed by pharmacist at reporting time (product dose omission issue). No additional adverse event.
Sex: F
Vaccine: HPV4, HPV9
Symptoms: Incomplete course of vaccination, No adverse event
Clinical narrative: Caller reports his daughter received her first dose of GARDASIL 9 on 04AUG2015, and she has not received the second or third doses; Product lot number issue; No additional AE reported; This spontaneous report was received from a consumer, referring to his daughter, a female patient of unknown age. The patient's pertinent medical history, concurrent conditions, concomitant medications, previous drug reactions, or allergies were not reported.  On 04-AUG-2015, the patient was vaccinated with the first dose of hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast) (GARDASIL 9) injection (strength, anatomical site of vaccination, and route of administration were not reported; lot number was reported as L010596 which was not valid for hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast) (GARDASIL 9). However, lot number L010596 was valid for quadrivalent human papillomavirus (types 6,11,16,18) recomb. vaccine (GARDASIL), expiration date 06-APR-2017) as prophylaxis (product lot number issue), and she had not received the second or third doses (inappropriate schedule of product administration). No additional adverse effect (AE) reported.
Sex: U
Vaccine: MMR
Symptoms: No adverse event, Product storage error
Clinical narrative: no adverse event; M-M-R II that underwent temperature excursion was administered; This spontaneous report was received from a nurse practitioner, referring to a patient of unknown age and gender. The patient's historical drugs, medical history, concomitant therapies, drugs allergies and concurrent conditions were not reported.   On 06-AUG-2021, the patient was vaccinated with improperly stored doses of Measles, Mumps, and Rubella (Wistar RA 27-3) Virus Vaccine, Live albumin status rHA (recombinant Human albumin) (M-M-R II) lot# T007235, expiraction date 27-FEB-2022, for prophylaxis (strength, dose, route and frequency were not reported).  The temperature excursion/time frame was of 47 Fahrenheit degrees (°F) (53°F) for 5 hours 0 minutes 0 seconds on 09-AUG-2021. However, a previous temperature excursion above 47°F (48°F) was reported in different dates: on 03-AUG-2021 for 11 hours 0 minutes and 0 seconds was reported, on 05-AUG-2021 for 8 hours 0 minutes and 0 seconds, on 06-AUG-2021 for 8 hours 30 minutes and 0 seconds and on 07-AUG-2021 for 29 hours 0 minutes and 0 seconds. A digital data logger was involved. No adverse effects were reported.
Age: 78.0
Sex: U
Vaccine: VARZOS
Symptoms: Herpes zoster
Clinical narrative: other zoster related injuries; shingles; Information has been received from a lawyer and an elderly patient of unknown age and gender regarding a case in litigation. Information about concurrent condition, medical history and concomitant medication was not reported. In or about 2014 (at approximately 78 years old), the patient was vaccinated with zoster vaccine live (ZOSTAVAX) (strength, dose, lot#, expiration date and route unknown) for the long-term prevention of shingles and zoster-related conditions. Subsequently, the patient was treated by a physician and other healthcare providers for the following injuries resulting from zoster vaccine live (ZOSTAVAX): shingles and other zoster related injuries. The outcome of these events was unknown.
Sex: U
Vaccine: MMRV
Symptoms: No adverse event, Product storage error
Clinical narrative: No additional adverse effect reported; Caller reported that a PROQUAD lot that underwent a temperature excursion was administered.; This spontaneous report was received from a medical assistant referring to a patient of unknown age and gender. The patient's pertinent medical history, concurrent conditions, previous drug reactions, allergies, or concomitant medications were not reported.   On 17-AUG-2021, the patient was vaccinated with improperly stored measles, mumps, rubella and varicella (Oka-Merck) virus vaccine live (rHA) (PROQUAD) injection as prophylaxis (lot number T037954 which has been verified to be valid, expiration date reported and validated as 09-MAY-2022) (dose, frequency, route of administration, and anatomical site of injection were not reported). The administered dose of the vaccine was stored at a temperature of -10 degrees Celsius (C) to 8 C (-5C), during a time frame of 0 hours 15 minutes and 0 seconds (product storage error). There was no previous temperature excursion. No additional adverse effects were reported in the patient.   This is one of two reports received from the same reporter.
Sex: U
Vaccine: VARZOS
Symptoms: Herpes zoster, Ill-defined disorder
Clinical narrative: shingles; other zoster related injuries; Information has been received from a lawyer referring to a currently 83 years old patient of unknown gender regarding a case in litigation. Information about concurrent condition, history condition and concomitant medication was not reported. On un known date(reported as on or about 40118), the patient was vaccinated with zoster vaccine live (ZOSTAVAX) (strength, dose, route, lot# and expiration date unknown) by a healthcare provider at a healthcare facility for the long-term prevention of shingles and zoster-related conditions. Subsequent to the inoculation (date not reported), the patient was treated by a physician at a healthcare facility and other healthcare providers for the following injuries resulting from zoster vaccine live (ZOSTAVAX) use: shingles and other zoster related injuries(Ill-defined disorder). The outcome of the events was unknown.
Age: 20.0
Sex: M
Vaccine: HEPA
Symptoms: No adverse event, Underdose
Clinical narrative: No additional adverse events reported; administration of a pediatric dose of VAQTA to a 20 year old male; administration of a pediatric dose of VAQTA to a 20 year old male; This spontaneous report as received from a nurse and refers to a 20-year-old male patient. No information regarding the patient's pertinent medical history, drug reactions or allergies and concomitant therapies was provided.     On 16-AUG-2021, the patient was vaccinated with a pediatric dose of hepatitis a vaccine, inactivated (VAQTA) lot # U013969 was confirmed to be valid, expiration date 06-FEB-2023, 0.5 milliliter (route of administration, anatomical location were not reported) for prophylaxis. No adverse effects were reported.
Sex: U
Vaccine: HEPA
Symptoms: No adverse event, Product storage error
Clinical narrative: No additional AE/PCQ reported; VAQTA administered after a temperature excursion; This spontaneous report was received from a medical assistance referring to a patient of unknown age and gender. The patient's medical history, concomitant medications, drug allergies, or reactions were not reported.   On 18-AUG-2021 the patient was vaccinated with a improperly stored dose of hepatitis a vaccine, inactivated(VAQTA) lot # T023913 has been verified to be valid expiration date 31-MAR-2021 for prophylaxis (strength and administration route were not provided) (product storage error).  The vaccine was exposed to a temperature above 9 Celsius degrees (C) for a time frame of 5 minutes; the vaccine did not experience previous temperature excursions, no adverse events were reported. combinationproductreport: Yes; brandname: VAQTA SYRINGE (DEVICE); commondevicename: Hepatitis A Vaccine, Inactivated; productcode: FMF; manufacturername: Merck; devicelotnumber: T023913; expirationdate: 31-MAR-2022; deviceage and unit: 0 ; operatorofdevice: Unknown; malfunction: Unknown; deviceusage: Initial; reasonfornoneval: 81 Other; labeledsingleusedevice: No; mdcpreportability: No; mdcpreprationale: Case information does not meet criteria for reportability
Age: 1.0
Sex: U
Vaccine: MMRV, VARCEL
Symptoms: Inappropriate schedule of product administration
Clinical narrative: A 12 months old who received both PROQUAD and VARIVAX; This spontaneous report was received from a nurse concerning a 12 month old patient. Information regarding the patient's medical history, concurrent conditions and concomitant medications was not reported.      On 17-AUG-2021, the patient was vaccinated with varicella virus vaccine live (oka/merck) (VARIVAX) and measles, mumps, rubella and varicella (oka-merck) virus vaccine live (PROQUAD) (inappropriate schedule of product administration), both for prophylaxis (strength, dose, route of administration, anatomical location, lot number and expiration date were not provided) .
Sex: F
Vaccine: HPV4
Symptoms: Precancerous condition, Surgery
Clinical narrative: she had pre cancerous symptoms after receiving the GARDASIL vaccine.; This spontaneous report was received from a consumer referring to herself as a female patient of unknown age. The patient's pertinent medical history, concomitant therapies, previous drug reactions, or allergies were not reported.     On an unknown date, the patient was vaccinated with quadrivalent human papillomavirus (Types 6,11,16,18) recomb. vaccine (GARDASIL) as prophylaxis (dose, route of administration, vaccination scheme frequency, anatomical location, lot number and expiration date were not reported).   On an unspecified date (reported as "after receiving the quadrivalent human papillomavirus (Types 6,11,16,18) recomb. vaccine (GARDASIL) vaccine"), the patient experienced pre-cancerous symptoms (precancerous condition). As a result, she had surgery (unspecified) for the symptoms. The outcome of the event was not reported.  The causality assessment between quadrivalent human papillomavirus (Types 6,11,16,18) recomb. vaccine (GARDASIL) and the event precancerous condition was not provided.  Upon internal review, the event precancerous condition was determined to be medically significant.
Sex: U
Vaccine: VARCEL
Symptoms: No adverse event, Product storage error
Clinical narrative: No additional AE/PQC's reported; excursions vaccine was administered to patients; This spontaneous report was received from a nurse referring to a patient of unknown age and gender. No information regarding the patient's concurrent conditions, medical history, drug reactions or allergies and concomitant medications was provided.  On 20-AUG-2021, the patient was vaccinated with improperly stored dose of varicella virus vaccine live (oka/merck)(VARIVAX)  lot # T002847, expiration date 23-JAN-2022 (dose number, dose and route of administration were not reported) for prophylaxis.  The vaccine was stored improperly in the temperature between 6 degrees Fahrenheit (F) to 14 degrees Fahrenheit (13.5 F) for the time frame of 57 minutes, and between 6 degrees Fahrenheit (F) to 14 degrees Fahrenheit (7.3 F) for  the time frame of 15 minutes. There was no previous temperature excursion. No adverse event was reported.  This is one of two reports from the same source.; Sender's Comments:  US-009507513-2108USA006114:
Sex: U
Vaccine: HPV9
Symptoms: Inappropriate schedule of product administration, No adverse event
Clinical narrative: The patient had the first dose of GARDASIL 9 in October 2020. The patient would like to continue the series, but has not yet received the second dose.; No AE reported; This spontaneous report was received from a physician's 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 an unspecified date in October 2020, the patient was vaccinated with their first dose of HPV rL1 6 11 16 18 31 33 45 52 58 VLP vaccine (yeast) (GARDASIL 9) 0.5 ml (route of administration, anatomical location, lot # and expiration date were not provided) for prophylaxis. It was reported, that they would like to continue the vaccination series, but has not yet received the second dose (inappropriate schedule of vaccine administered). No adverse event (AE) was reported.
Sex: U
Vaccine: PPV
Symptoms: No adverse event, Product storage error
Clinical narrative: No adverse event; temperature excursion / temperature 30.6 F; This spontaneous report was received from a nurse 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 19-AUG-2021, the patient was vaccinated with an improperly stored dose of pneumococcal vaccine, polyvalent (23-valent) (PNEUMOVAX23) 0.5 ml, lot # T009743, expiration date 27-JAN-2022 (route of administration and anatomical location were not provided) for prophylaxis. The administered vaccine was stored in a temperature of 30.6 degrees Fahrenheit (F) for 26 hours and 14 minutes. Previous temperature excursions were reported: 34.9 F for 1 hour 54 minutes and 48.6 F for 21 hours. No adverse event (AE) was reported.  This is one of three reports from the same reporter. combinationproductreport: Yes; brandname: PNEUMOVAX23 SYRINGE (DEVICE); commondevicename: Pneumococcal Vaccine, Polyvalent (23-valent); productcode: FMF; devicetype: SYRINGE, PISTON (FMF); manufacturername: Merck Sharp & Dohme Corp. devicelotnumber: T009743; expirationdate: 27-JAN-2022; deviceage and unit: 0 ; malfunction: Unknown; deviceusage: Initial; reasonfornoneval: 81 Other; labeledsingleusedevice: No; mdcpreportability: No; mdcpreprationale: Case information does not meet criteria for reportability; Sender's Comments:  US-009507513-2108USA006446: US-009507513-2108USA006422:
Sex: U
Vaccine: PPV, UNK
Symptoms: No adverse event, Product storage error
Clinical narrative: No AE reported; temperature excursion / temperature 30.6 F; This spontaneous report was received from a nurse 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 17-AUG-2021, the patient was vaccinated with an improperly stored dose of pneumococcal vaccine, polyvalent (23-valent) (PNEUMOVAX23) 0.5 ml, lot # T009743, expiration date 27-JAN-2022 (route of administration and anatomical location were not provided) for prophylaxis. The administered vaccine was stored in a temperature of 30.6 degrees Fahrenheit (F) for 26 hours and 14 minutes. Previous temperature excursions were reported: 34.9 F for 1 hour 54 minutes and 48.6 F for 21 hours. No adverse event (AE) was reported.  This is one of three reports from the same reporter. combinationproductreport: Yes; brandname: PNEUMOVAX23 SYRINGE (DEVICE); commondevicename: Pneumococcal Vaccine, Polyvalent (23-valent); productcode: FMF; devicetype: SYRINGE, PISTON (FMF); manufacturername: Merck Sharp & Dohme Corp devicelotnumber: T009743; expirationdate: 27-JAN-2022; deviceage and unit: 0 ; malfunction: Unknown; deviceusage: Initial; reasonfornoneval: 81 Other; labeledsingleusedevice: No; mdcpreportability: No; mdcpreprationale: Case information does not meet criteria for reportability; Sender's Comments:  US-009507513-2108USA006442:01995286 US-009507513-2108USA006422:
Sex: U
Vaccine: MMR
Symptoms: Expired product administered
Clinical narrative: No additional AEs or PQC reported; expired dose of MMR II was administered; This spontaneous report as received from a physician refers to a patient of unknown age and gender. There was no information about the patient's medical history, concurrent conditions or concomitant medication.  On 24-AUG-2021,  the patient was vaccinated with an expired dose of   measles, mumps, and rubella (wistar ra 27-3) virus vaccine, live(M-M-R II),  subcutaneously, dose: 0.5 milliliter,  lot # S025158, expiration date : 13-AUG-2021;  for prophylaxis. No other information provided. No additional AEs or PQC reported.
Sex: U
Vaccine: VARCEL
Symptoms: Product storage error
Clinical narrative: no signs of symptoms reported; temperature excursion on VARIVAX: product was administered to one patient after the excursion occurred; This spontaneous report was received from a nurse prescriber referring to a patient of unknown age and gender. The patient's concurrent conditions and medical history were not reported. There was no concomitant medication reported.   On 22-AUG-2021, the patient was vaccinated with a varicella virus vaccine live (oka/merck)(VARIVAX) (lot # T032322, expiration date: 22-SEP-2022, for prophylaxis) that had a temperature excursion. The temperature excursion was for a time frame of 36 hours at 68 degrees Fahrenheit. There was no previous temperature excursion. No signs or symptoms were reported after the administration.
Sex: F
Vaccine: VARCEL
Symptoms: Dry eye, Facial paresis, Herpes zoster oticus, Rash, Rash vesicular
Clinical narrative: reactivation of varicella / the patient previously received VARIVAX; Ramsay Hunt syndrome / increased dry eyes/right sided facial weakness; This spontaneous report was received from a physician referring to a 16 year old female patient. The patient had no relevant medical history, drug reactions/allergies or concomitant medications.  On an unknown date, the patient was vaccinated with varicella virus vaccine live (oka/merck)(VARIVAX) for prophylaxis (strength, route, dosage schedule, lot number and expiration date were not reported).         Since an unknown date, the patient had "reactivation of varicella". The patient experienced a herpetic rash with right trigeminal distribution and rash in her right ear canal. No rash was noted on the patient's tympanic membrane. There was no involvement of the optic nerve however the patient experienced increased dry eyes and right sided facial weakness. The patient was diagnosed with Ramsay Hunt syndrome and was initially given oral acyclovir however, due to worsening symptoms, had to be hospitalized on 22-AUG-2021 and given intravenous acyclovir.   The physician reported that the patient was improving however still had right sided facial weakness. Causality assessment was not provided.   Upon internal review, Ramsay Hunt syndrome was considered a medically significant event.
Sex: F
Vaccine: VARCEL
Symptoms: Varicella post vaccine
Clinical narrative: reactivation of varicella / the patient previously received VARIVAX; Ramsay Hunt syndrome / increased dry eyes/right sided facial weakness; This spontaneous report was received from a physician referring to a 16 year old female patient. The patient had no relevant medical history, drug reactions/allergies or concomitant medications.  On an unknown date, the patient was vaccinated with varicella virus vaccine live (oka/merck)(VARIVAX) for prophylaxis (strength, route, dosage schedule, lot number and expiration date were not reported).         Since an unknown date, the patient had "reactivation of varicella". The patient experienced a herpetic rash with right trigeminal distribution and rash in her right ear canal. No rash was noted on the patient's tympanic membrane. There was no involvement of the optic nerve however the patient experienced increased dry eyes and right sided facial weakness. The patient was diagnosed with Ramsay Hunt syndrome and was initially given oral acyclovir however, due to worsening symptoms, had to be hospitalized on 22-AUG-2021 and given intravenous acyclovir.   The physician reported that the patient was improving however still had right sided facial weakness. Causality assessment was not provided.   Upon internal review, Ramsay Hunt syndrome was considered a medically significant event.
Sex: U
Vaccine: VARZOS
Symptoms: Herpes zoster, Vaccination failure
Clinical narrative: I never had shingles until I got the vaccination that prevents it./ Suspected Vaccination Failure; I never had shingles until I got the vaccination that prevents it.; 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 reporter was the patient. The age at vaccination was not reported. The patient never had shingles until he/she got the vaccination that prevents shingles. This case was considered as suspected vaccination failure, since the details regarding the completion of the primary immunization for shingles, time to onset for event and laboratory confirmation for shingles were not provided.
Sex: U
Vaccine: VARZOS
Symptoms: Herpes zoster
Clinical narrative: got a very light case/got after my injection was extremely mild, less than half a dozen outbreaks; This case was reported by a consumer and described the occurrence of shingles in a patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   The patient's past medical history included shingles (had a severe case of shingles) and covid-19. Concurrent medical conditions included autoimmune disorder.   On an unknown date, the patient received the 1st dose of Shingles vaccine. On an unknown date, unknown 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: This case was reported by the patient himself/ herself. The age at vaccination was not reported. The patient got the 1st dose of Shingle shot and got a very light case of shingles and it was extremely mild, less than half a dozen outbreaks. The patient had first called his/her doctor's office and informed, but they knew nothing about the correlation between the two. The patient had autoimmune conditions and fully believe that contributed to his/her rare side effects.  The follow-up would not possible as no contact details were available. For tolerance to 2nd dose, refer case US2021AMR176035.; Sender's Comments:  US-GLAXOSMITHKLINE-US2021AMR176035:Same reporter
Sex: U
Vaccine: VARZOS
Symptoms: Feeling abnormal, Influenza like illness, Malaise
Clinical narrative: got sick, like flu.; This case was reported by a consumer and described the occurrence of influenza-like symptoms in a patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   The patient's past medical history included shingles (had a severe case of shingles) and covid-19. Previously administered products included Shingles vaccine with an associated reaction of herpes zoster (1st dose received on an unknown date, refer case US2021AMR176026). Concurrent medical conditions included autoimmune disorder.   On an unknown date, the patient received the 2nd dose of Shingles vaccine. On an unknown date, unknown after receiving Shingles vaccine, the patient experienced influenza-like symptoms. On an unknown date, the outcome of the influenza-like symptoms was unknown.   It was unknown if the reporter considered the influenza-like symptoms to be related to Shingles vaccine.  Additional details were provided as follows: This case was reported by the patient himself/ herself. The age at vaccination was not reported. The patient received 2nd shot and got sick, like flu. The patient stated he/she was not critically ill, but pretty miserable for a while, afterwards it was wonderful to actually get out of the house. The patient had autoimmune conditions and fully believe that contributed to his/her rare side effects. The follow-up would not possible as no contact details were available.; Sender's Comments:  US-GLAXOSMITHKLINE-US2021AMR176026:Same reporter
Sex: M
Vaccine: VARZOS
Symptoms: Social problem
Clinical narrative: Was due for the 2nd when Covid hit hard; This case was reported by a consumer via (interactive digital media and described the occurrence of social problem in a male patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   The patient's past medical history included neurological disorder nos and pruritus. Previously administered products included Gabapentine (had gabapentin for nerves ot itch) and Shingles vaccine (1st dose received on an unknown date, refer case US2021AMR176118).   On an unknown date, the patient received the 2nd dose of Shingles vaccine. On an unknown date, unknown after receiving Shingles vaccine, the patient experienced social problem. On an unknown date, the outcome of the social problem was unknown.  Additional details were provided as follows: The reporter was the patient's wife. The age at vaccination was not applicable for this report. The reporter stated that, the patient had been on Gabapentin for the nerves/ itch. The patient was due for the 2nd dose when Covid hit hard. The follow-up would not possible as no contact details were available.; Sender's Comments:  US-GLAXOSMITHKLINE-US2021AMR176118:Same reporter.
Sex: U
Vaccine: VARZOS
Symptoms: Erythema, Illness, Pain in extremity
Clinical narrative: Arm is still a little red; Arm is still a little sore; This case was reported by a consumer via interactive digital media and described the occurrence of erythema of extremities in a patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   Previously administered products included Shingles vaccine with an associated reaction of illness (1st dose received on an unknown date, refer case US2021AMR176120).   In July 2021, the patient received the 2nd dose of Shingles vaccine. On an unknown date, less than a month after receiving Shingles vaccine, the patient experienced erythema of extremities and pain in arm. On an unknown date, the outcome of the erythema of extremities and pain in arm were not recovered/not resolved.  It was unknown if the reporter considered the erythema of extremities and pain in arm to be related to Shingles vaccine.  Additional details were reported as follows: This case was reported by the patient for herself or himself. The age at vaccination was not reported. The patient received 2nd dose of shingles vaccine about a month ago from reporting date and his/her arm was still a little red and sore. This is 1 of 3 cases reported by the same reporter. The follow-up would not possible as no contact details were available.; Sender's Comments:  US-GLAXOSMITHKLINE-US2021AMR176120:Same reporter US-GLAXOSMITHKLINE-US2021AMR176129:Same reporter
Age: 0.17
Sex: F
Vaccine: HIBV
Symptoms: Expired product administered
Clinical narrative: received expired dose; This case was reported by a nurse via sales rep and described the occurrence of expired vaccine used in a 2-month-old female patient who received Hib (Hiberix) (batch number unknown, expiry date 8th August 2021) for prophylaxis.   On 17th August 2021, the patient received Hiberix. On 17th August 2021, unknown after receiving Hiberix, the patient experienced expired vaccine used. On an unknown date, the outcome of the expired vaccine used was unknown.  Additional details were provided as follows: The reporter stated that, the patient received expired dose of Hiberix, which led to expired vaccine used. The reporter stated that, the dose was invalid as per Centre of disease guidance site to readministered dose. The reporter did not consent to follow up.