chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 63.0
Sex: M
Vaccine: COVID19
Symptoms: Urine analysis
Clinical narrative: Chills, head ache, back pain and kidney pain, all within 1 week  On April 25, 2021 attended emergency and was sent home.  They found nothing   Chills, head ache, chest and kidney pain on October 13, 2021   Went to Hospital and received a d-dimer test.  Cat Scan showed Pulmonary Embolism left lung
Age: 64.0
Sex: F
Vaccine: COVID19
Symptoms: Abdominal distension, Abdominal pain upper, Computerised tomogram, Dysstasia, Flank pain
Clinical narrative: On 7th day my stomach started hurting and swelling. The pain was intense by the eleventh day including the left side. For the next week  the swelling and pain got worse and worse. I could not zip up my pants from the swelling. By the 14th day I had to leave work and go to the emergency room. I could not go to the bathroom because I was so swollen internally. I felt like I was going to throw up while I was in the waiting room. I couldn't stand up straight from the pain and also could taste everything starting to come up from my stomach and felt the burning in  my throat. I had cramping in my legs, feet and hands.
Age: 64.0
Sex: F
Vaccine: COVID19
Symptoms: Gastrointestinal tube insertion, Impaired work ability, Muscle spasms, Nausea, Throat irritation
Clinical narrative: On 7th day my stomach started hurting and swelling. The pain was intense by the eleventh day including the left side. For the next week  the swelling and pain got worse and worse. I could not zip up my pants from the swelling. By the 14th day I had to leave work and go to the emergency room. I could not go to the bathroom because I was so swollen internally. I felt like I was going to throw up while I was in the waiting room. I couldn't stand up straight from the pain and also could taste everything starting to come up from my stomach and felt the burning in  my throat. I had cramping in my legs, feet and hands.
Age: 48.0
Sex: F
Vaccine: FLU4
Symptoms: Aphonia, Arthralgia, Asthenia, Body temperature increased, Chills
Clinical narrative: Confusion, temperature over 102 degrees, chills, joint pain, muscle pain, headache, diahrea, cough, difficulty breathing, facial swelling, fatigue, slept for 24 hrs followed by additional long periods of sleep, weakness, lightheadedness, loss of voice, tingling in the extremities
Age: 48.0
Sex: F
Vaccine: FLU4
Symptoms: Confusional state, Cough, Diarrhoea, Dizziness, Dyspnoea
Clinical narrative: Confusion, temperature over 102 degrees, chills, joint pain, muscle pain, headache, diahrea, cough, difficulty breathing, facial swelling, fatigue, slept for 24 hrs followed by additional long periods of sleep, weakness, lightheadedness, loss of voice, tingling in the extremities
Age: 48.0
Sex: F
Vaccine: FLU4
Symptoms: Fatigue, Headache, Hypersomnia, Myalgia, Paraesthesia
Clinical narrative: Confusion, temperature over 102 degrees, chills, joint pain, muscle pain, headache, diahrea, cough, difficulty breathing, facial swelling, fatigue, slept for 24 hrs followed by additional long periods of sleep, weakness, lightheadedness, loss of voice, tingling in the extremities
Age: 48.0
Sex: F
Vaccine: FLU4
Symptoms: Swelling face
Clinical narrative: Confusion, temperature over 102 degrees, chills, joint pain, muscle pain, headache, diahrea, cough, difficulty breathing, facial swelling, fatigue, slept for 24 hrs followed by additional long periods of sleep, weakness, lightheadedness, loss of voice, tingling in the extremities
Age: 27.0
Sex: M
Vaccine: FLU4
Symptoms: Agitation, Hypertension, Palpitations, Pruritus, Urticaria
Clinical narrative: Hives and itchiness all over body, high blood pressure,  agitation, palpitations.  Vaccine administered by pharmacy.  I had to go to the emergency room on 10/22/2021 and was treated with Benadryl, Prednisone, and Ativan.
Age: 63.0
Sex: F
Vaccine: COVID19
Symptoms: Abdominal discomfort, Arthralgia, Blood test, Computerised tomogram, Dyspnoea
Clinical narrative: NOTE: the adverse effects were experienced sequentially between April 18- June 30, 2021 1) April 18-26, 2021: itching in both hands; prescribed benadryl @ 25mg, 2 pills nightly AND tagamet@ 200 mf daily; symptoms alleviated by April 26, 2021 2)April 27, 2021: slight nausea and upset stomach 3) April 28, 2021: muscle ache in shoulders only 4)~ April 29- May 3, 2021: muscle aches in both legs and arms. Intensity increased to pain level 9 on scale of "1- 10"; Treatment medications given at hospital emergency room: iohexol, ketorolac, and naproxen 5) ~ May 1, 2021: shortness of breath 6) ~ May 1- June 30, 2021: fatigue
Age: 63.0
Sex: F
Vaccine: COVID19
Symptoms: Fatigue, Myalgia, Nausea, Pruritus, Ultrasound scan
Clinical narrative: NOTE: the adverse effects were experienced sequentially between April 18- June 30, 2021 1) April 18-26, 2021: itching in both hands; prescribed benadryl @ 25mg, 2 pills nightly AND tagamet@ 200 mf daily; symptoms alleviated by April 26, 2021 2)April 27, 2021: slight nausea and upset stomach 3) April 28, 2021: muscle ache in shoulders only 4)~ April 29- May 3, 2021: muscle aches in both legs and arms. Intensity increased to pain level 9 on scale of "1- 10"; Treatment medications given at hospital emergency room: iohexol, ketorolac, and naproxen 5) ~ May 1, 2021: shortness of breath 6) ~ May 1- June 30, 2021: fatigue
Age: 49.0
Sex: M
Vaccine: COVID19
Symptoms: Arthralgia, Fatigue, Headache, Myalgia, Pyrexia
Clinical narrative: Headache, fever, fatigue, muscle pain, joint pain. Similar symptoms improved with time after the first dose.
Age: 39.0
Sex: F
Vaccine: COVID19
Symptoms: Chest discomfort, Dyspnoea, Electrocardiogram, Fatigue, Hypertension
Clinical narrative: -2 hours after injection of booster, Experienced sudden onset tachycardia with HR or 130-140 lasting for approx 30-40 min after injection time.  Experienced shortness of breath and mild chest discomfort.  Blood pressure at this time was 140-90's, much higher than normal.  Was advised by Nurse consult to be evaluated.  While waiting in Urgent Care, tachycardia suddenly resolved to HR of 80-90's.  Felt extreme fatigue afterwards.
Age: 39.0
Sex: F
Vaccine: COVID19
Symptoms: Physical examination, Tachycardia
Clinical narrative: -2 hours after injection of booster, Experienced sudden onset tachycardia with HR or 130-140 lasting for approx 30-40 min after injection time.  Experienced shortness of breath and mild chest discomfort.  Blood pressure at this time was 140-90's, much higher than normal.  Was advised by Nurse consult to be evaluated.  While waiting in Urgent Care, tachycardia suddenly resolved to HR of 80-90's.  Felt extreme fatigue afterwards.
Age: 76.0
Sex: F
Vaccine: COVID19
Symptoms: Anticoagulant therapy, Asthenia, Atrial appendage closure, Computerised tomogram thorax abnormal, Condition aggravated
Clinical narrative: Patient reports receiving the 3rd dose of Pfizer vaccine on 10/15/2021.  The next day, she had increased shortness of breath and weakness.  Her primary care provider ordered a CT chest PE study, which was completed on 10/19/2021.  This reported bilateral pulmonary emboli with associated right heart strain.  Patient presented to the emergency room, initiated on heparin infusion.  There was consideration for catheter-directed thrombolytic therapy but we ultimately did not pursue.   She had no other known risk factors or instigating events for development of a pulmonary embolism.  She denies a history of blood clots.  No recent surgeries or immobilization.  No recent travel.  No long airplane rides or car rides.  She has 1 sister who has a blood clot, diagnosed recently, but otherwise no family history.  SHE IS CURRENTLY HOSPITALIZATION, STILL ADMITTED.
Age: 76.0
Sex: F
Vaccine: COVID19
Symptoms: Dyspnoea, Electrocardiogram ST-T segment abnormal, Embolism, Fatigue, Pulmonary embolism
Clinical narrative: Patient reports receiving the 3rd dose of Pfizer vaccine on 10/15/2021.  The next day, she had increased shortness of breath and weakness.  Her primary care provider ordered a CT chest PE study, which was completed on 10/19/2021.  This reported bilateral pulmonary emboli with associated right heart strain.  Patient presented to the emergency room, initiated on heparin infusion.  There was consideration for catheter-directed thrombolytic therapy but we ultimately did not pursue.   She had no other known risk factors or instigating events for development of a pulmonary embolism.  She denies a history of blood clots.  No recent surgeries or immobilization.  No recent travel.  No long airplane rides or car rides.  She has 1 sister who has a blood clot, diagnosed recently, but otherwise no family history.  SHE IS CURRENTLY HOSPITALIZATION, STILL ADMITTED.
Age: 76.0
Sex: F
Vaccine: COVID19
Symptoms: Right ventricular dilatation, Thrombosis
Clinical narrative: Patient reports receiving the 3rd dose of Pfizer vaccine on 10/15/2021.  The next day, she had increased shortness of breath and weakness.  Her primary care provider ordered a CT chest PE study, which was completed on 10/19/2021.  This reported bilateral pulmonary emboli with associated right heart strain.  Patient presented to the emergency room, initiated on heparin infusion.  There was consideration for catheter-directed thrombolytic therapy but we ultimately did not pursue.   She had no other known risk factors or instigating events for development of a pulmonary embolism.  She denies a history of blood clots.  No recent surgeries or immobilization.  No recent travel.  No long airplane rides or car rides.  She has 1 sister who has a blood clot, diagnosed recently, but otherwise no family history.  SHE IS CURRENTLY HOSPITALIZATION, STILL ADMITTED.
Age: 50.0
Sex: F
Vaccine: COVID19
Symptoms: Axillary pain, Breast pain, Breast swelling, Chest pain, Lymphadenopathy
Clinical narrative: Having pain and swelling on left side of chest, left underarm and left side of left breast.  Painful to light touch.  Started in the early morning hours on 10/21/21. Have not been seen by PCP yet.
Age: 50.0
Sex: F
Vaccine: COVID19
Symptoms: Swelling
Clinical narrative: Having pain and swelling on left side of chest, left underarm and left side of left breast.  Painful to light touch.  Started in the early morning hours on 10/21/21. Have not been seen by PCP yet.
Age: 29.0
Sex: F
Vaccine: COVID19
Symptoms: Asthenia, Chills, Headache, Heart rate increased, Hyperhidrosis
Clinical narrative: Elevated heart rate, fever over 101.0, sweating, severe shivering, headache, sleeplessness, weakness, and nausea.
Age: 29.0
Sex: F
Vaccine: COVID19
Symptoms: Insomnia, Nausea, Pyrexia
Clinical narrative: Elevated heart rate, fever over 101.0, sweating, severe shivering, headache, sleeplessness, weakness, and nausea.
Age: 38.0
Sex: M
Vaccine: COVID19
Symptoms: Chills, Fall, Feeling of body temperature change, Gait disturbance, Hyperhidrosis
Clinical narrative: On April , 2020 at 2pm I received Johnson and Johnsons Janseen Covid 19 vaccination. Shortly thereafter within the first four to six hours I could feel my body transition into a mode of what I can only relate to OxyContin/Heroin withdrawal.  That first night my body felt like I was freezing and burning. I was shaking profusely. My legs began to hurt so bad I couldn?t walk. And I was sweating so badly I soaked any and all clothes I attempted to wear. The following day I could barely walk. I was in massive pain. And shivering so bad had to light a fire in my fireplace and nearly severed off my left index finger trying to cut wood. The third day I still felt like hell. But began to move around and ventured out to the pharmacy for pedialyte and flu meds to treat the flu like symptoms the vaccine brought on. This is where the First tru sign of trouble began. As while walking thru pharmacy my legs completely locked and gave out causing me to literally just collapse to the floor. I was fine (in my head) but my legs just stopped. This would cause me the need for help back to my feet. Since that day my legs constantly lock at the joints as well as my wrists. At times. But the legs hurt so bad I began to scream for help. In fact I?m reluctant to obtain any other vaccinations in my state as the state was pitiful at addressing Covid. And still pathetic at its response. My body is far from the same as it was. And before the pandemic I work at a job that?s physically demanding. That I probably can?t do anymore. I am grateful for the vaccine however so far have only had regrets to what it?s done to my body.
Age: 38.0
Sex: M
Vaccine: COVID19
Symptoms: Influenza like illness, Joint lock, Muscular weakness, Pain, Pain in extremity
Clinical narrative: On April , 2020 at 2pm I received Johnson and Johnsons Janseen Covid 19 vaccination. Shortly thereafter within the first four to six hours I could feel my body transition into a mode of what I can only relate to OxyContin/Heroin withdrawal.  That first night my body felt like I was freezing and burning. I was shaking profusely. My legs began to hurt so bad I couldn?t walk. And I was sweating so badly I soaked any and all clothes I attempted to wear. The following day I could barely walk. I was in massive pain. And shivering so bad had to light a fire in my fireplace and nearly severed off my left index finger trying to cut wood. The third day I still felt like hell. But began to move around and ventured out to the pharmacy for pedialyte and flu meds to treat the flu like symptoms the vaccine brought on. This is where the First tru sign of trouble began. As while walking thru pharmacy my legs completely locked and gave out causing me to literally just collapse to the floor. I was fine (in my head) but my legs just stopped. This would cause me the need for help back to my feet. Since that day my legs constantly lock at the joints as well as my wrists. At times. But the legs hurt so bad I began to scream for help. In fact I?m reluctant to obtain any other vaccinations in my state as the state was pitiful at addressing Covid. And still pathetic at its response. My body is far from the same as it was. And before the pandemic I work at a job that?s physically demanding. That I probably can?t do anymore. I am grateful for the vaccine however so far have only had regrets to what it?s done to my body.
Age: 38.0
Sex: M
Vaccine: COVID19
Symptoms: Tremor
Clinical narrative: On April , 2020 at 2pm I received Johnson and Johnsons Janseen Covid 19 vaccination. Shortly thereafter within the first four to six hours I could feel my body transition into a mode of what I can only relate to OxyContin/Heroin withdrawal.  That first night my body felt like I was freezing and burning. I was shaking profusely. My legs began to hurt so bad I couldn?t walk. And I was sweating so badly I soaked any and all clothes I attempted to wear. The following day I could barely walk. I was in massive pain. And shivering so bad had to light a fire in my fireplace and nearly severed off my left index finger trying to cut wood. The third day I still felt like hell. But began to move around and ventured out to the pharmacy for pedialyte and flu meds to treat the flu like symptoms the vaccine brought on. This is where the First tru sign of trouble began. As while walking thru pharmacy my legs completely locked and gave out causing me to literally just collapse to the floor. I was fine (in my head) but my legs just stopped. This would cause me the need for help back to my feet. Since that day my legs constantly lock at the joints as well as my wrists. At times. But the legs hurt so bad I began to scream for help. In fact I?m reluctant to obtain any other vaccinations in my state as the state was pitiful at addressing Covid. And still pathetic at its response. My body is far from the same as it was. And before the pandemic I work at a job that?s physically demanding. That I probably can?t do anymore. I am grateful for the vaccine however so far have only had regrets to what it?s done to my body.
Age: 54.0
Sex: M
Vaccine: FLUR4
Symptoms: Arthralgia, Diarrhoea, Feeling cold, Headache, Oesophageal achalasia
Clinical narrative: Chills Aches Headache Fever Diarrhea Knee pain Using Tylenol
Age: 54.0
Sex: M
Vaccine: FLUR4
Symptoms: Pyrexia
Clinical narrative: Chills Aches Headache Fever Diarrhea Knee pain Using Tylenol
Age: 35.0
Sex: F
Vaccine: COVID19
Symptoms: Arthralgia, Pain of skin
Clinical narrative: Severe pain on skin; Severe pain at joints; This is a spontaneous report from a non-contactable consumer, the patient. A 35-year-old non-pregnant female patient received the second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EW0158) via an unspecified route of administration in the right arm on 23Apr2021 at 09:30 (at the age of 35-years-old) as a single dose for COVID-19 immunisation. Medical history and concomitant medications were not reported. Prior to the vaccination, the patient was not diagnosed with COVID-19. The patient did not receive any other vaccine within four weeks prior to the COVID vaccine. The patient previously received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EN6207) via an unspecified route of administration in the right arm on 02Apr2021 at 10:15 (at the age of 35-years-old) as a single dose for COVID-19 immunisation. On 24Apr2021 at 01:00, the patient experienced severe pain on skin and at joints. The events did not result in doctor or other healthcare professional office/clinic, emergency room/department or urgent care. No therapeutic measures were taken as a result of the reported events. Since the vaccination, the patient had not been tested for COVID-19.The clinical outcome of the events severe pain on skin and at joints were unknown at the time of this report.  No follow-up attempts are possible. No further information is expected.
Sex: U
Vaccine: MMRV
Symptoms: No adverse event, Product storage error
Clinical narrative: No additional AE reported; PROQUAD was admnistered after temperature excursion; This spontaneous report was received from a nurse and refers to a patient of unknown age and gender. The patient's pertinent medical history, drug reactions or allergies, and concomitant medications were not reported.  On 13-AUG-2021, the vaccine measles, mumps, rubella and varicella (oka-merck) virus vaccine live (rHA) (PROQUAD) experienced a temperature excursion at a temperature of -7.7°C with a time frame of 30 minutes. On 18-AUG-2021, the patient was vaccinated with the second dose of measles, mumps, rubella and varicella (oka-merck) virus vaccine live (rHA) (PROQUAD) 0 .5 milliliter, lot number T036735 with expiration date 28-APR-2022 for prophylaxis (Product storage error) (route of administration and anatomical location was not reported). There was no previous temperature excursions. No additional adverse events (AE) reported.
Sex: U
Vaccine: VARZOS
Symptoms: Herpes zoster, Ill-defined disorder
Clinical narrative: shingles and other zoster-related conditions; shingles and other zoster-related conditions; This initial spontaneous report was received on from a lawyer regarding a case in litigation and refers to a currently 75-years-old patient of unknown gender. The patient's concurrent conditions, medical history and concomitant medication were not provided.   On or about 01-JUN-2016, the patient was vaccinated with a dose zoster vaccine live (ZOSTAVAX) (dosage regimen was not reported) for the long-term prevention of shingles (herpes zoster) and zoster-related conditions.  On an unspecified date, subsequent to the patient vaccination, the patient was treated by a physician for the following injuries resulting from the zoster vaccine live (ZOSTAVAX) vaccination: herpes zoster-related injuries (ill-defined disorder). At the reporting time, the outcome of the event was unknown.   The reporter considered the events of herpes zoster-related injuries (ill-defined disorder) to be related to zoster vaccine live (ZOSTAVAX).
Sex: M
Vaccine: PPV
Symptoms: Anaemia, Illness, Oesophageal achalasia, Pyrexia
Clinical narrative: PNEUMOVAX caused anemia; inflammation of his arm; fever that was "a bit high; This spontaneous report as received from a consumer refers to a 68-year-old male patient with adverse reaction and prophylaxis. The patient did not have any known allergies or reactions. The patient did not have any medical history. Concomitant mediation was reported as none. Historical vaccines include: covid-19 vaccine mrna (mrna 1273) (MODERNA COVID-19 VACCINE) administered on 25-FEB-2021. The same day, on 25-FEB-2021 the patient experienced a "bad reaction" (adverse reaction) for a week (stop date : 04-MAR-2021).   On 11-APR-2021, the patient was vaccinated with a dose of pneumococcal vaccine, polyvalent (23-valent) (PNEUMOVAX23) for prophylaxis (dose, route of administration, lot number and expiration date were not reported which resulted in inflammation of his arm (inflammation), approximately on the same date (conflicting information also reported as 25-FEB-2021).   He mentioned the "bad reaction"(adverse reaction), he received from the covid-19 vaccine mrna (mrna 1273) (MODERNA COVID-19 VACCINE) may have gotten worse after receiving the pneumococcal vaccine, polyvalent (23-valent) (PNEUMOVAX23) vaccine.   The patient reported that the inflammation from the pneumococcal vaccine, polyvalent (23-valent) (PNEUMOVAX23) vaccine caused anemia, on an an unknown date in 2021 and sometimes he would have a fever that was "a bit high"(pyrexia). He stated that he would feel "achy and sick" if he did not take any ibuprofen. He reported that he is still having these problems even though it had been months now and he was wondering if this is a common side effect from the pneumococcal vaccine, polyvalent (23-valent) (PNEUMOVAX23) vaccine.No laboratory/diagnostic tests were reported.Treatment included : ibuprofen and  prednisone (manufacturer unspecified).  The outcome of inflammation, pyrexia, and anaemia was reported as not recovered.   The reporter considered anaemia to be related to Pneumococcal Vaccine, Polyvalent (23-valent)(PNEUMOVAX23).  The causality of the remaining events was unspecified for Pneumococcal Vaccine, Polyvalent (23-valent)(PNEUMOVAX23).
Age: 63.0
Sex: U
Vaccine: VARZOS
Symptoms: Death, Herpes zoster
Clinical narrative: wrongful death; shingles; Information has been received from a lawyer concerning a case in litigation and refers to a patient of unknown age and gender. The patient's concurrent conditions, historical conditions and concomitant therapy were not reproted. On or aobut 13-MAR-2015, the 63-years-old patient was vaccinated with a dose of zoster vaccine live( ZOSTAVAX) (dose, route of administration, lot # and expiration date were not reported) for the long-term prevention of shingles and zoster-related conditions in a pharmacy by a pharmacist. Subsequently, the patient was treated by a healthcare provider at a family practice for the following injuries resulting from the patient's zoster vaccine live (ZOSTAVAX) use: shingles. The outcome of shingles was unknown. Specific allegations also included wrongful death on an unspecified date. The reporter considered the events to be related to zoster vaccine live (ZOSTAVAX).
Age: 68.0
Sex: U
Vaccine: VARZOS
Symptoms: Death, Herpes zoster
Clinical narrative: wrongful death; shingles; Information has been received from a lawyer concerning a case in litigation and refers to a patient of unknown age and gender. The patient's concurrent conditions, medical history and concomitant therapy were not reported. On or about 19-OCT-2014, the 68-years-old patient was vaccinated with a dose of zoster vaccine live (ZOSTAVAX) for the long-term prevention of shingles and zoster-related conditions in a pharmacy by a pharmacist. Subsequently, the patient was treated by a healthcare provider at a hospital (unspecified if hospitalized or not) for the following injuries resulting from  zoster vaccine live (ZOSTAVAX) use: shingles. The outcome of shingles was unknown. Specific allegations also included wrongful death on an unspecified date. The reporter considered the events to be related to zoster vaccine live (ZOSTAVAX).
Age: 77.0
Sex: F
Vaccine: VARZOS
Symptoms: Herpes zoster, Ophthalmic herpes zoster
Clinical narrative: Herpes Zoster, Ophthalmicus/herpes zoster with ocular movement; Zoster-related injuries; Herpes Zoster, Ophthalmicus/herpes zoster with ocular movement; Information has been received from a lawyer concerning a case in litigation and refers to a female patient of unknown age. The patient's concurrent conditions, historical conditions and concomitant therapies were not reported. On or about 04-NOV-2011, the 77-years-old patient was vaccinated with a dose of zoster vaccine live (ZOSTAVAX) for the long-term prevention of shingles and zoster-related conditions by a pharmacist in a pharmacy. Subsequently, the patient  was treated by healthcare providers, including but not limited to a physician for the following injuries resulting from zoster vaccine live (ZOSTAVAX) use: Herpes Zoster, Ophthalmicus/herpes zoster with ocular movement, and other Zoster-related injuries. The outcome of the events was unknown. The reporter considered the events to be related to zoster vaccine live (ZOSTAVAX).     Upon internal review, the event of ophthalmic herpes zoster was considered to be medically significant.
Sex: U
Vaccine: VARZOS
Symptoms: Herpes zoster, Ill-defined disorder
Clinical narrative: herpes zoster; ill-defined disorder; This spontaneous report was received from a lawyer and refers to a patient of unknown age and gender concerning a case in litigation. The patient's concurrent conditions, medical history, historical drugs and concomitant therapies were not reported.  On 03-OCT-2013, the patient was vaccinated with zoster vaccine live (ZOSTAVAX) (dose, route, lot number and expiration date were not reported) for long-term prevention of shingles and zoster-related conditions.  On an unknown date (reported as subsequent to inoculation), the patient experienced herpes zoster and other zoster-related conditions (ill-defined disorder). The patient was treated with unspecified medications. The patient would continued suffering ongoing injuries. Significant medical and related expenses included care for hospitalization.  The outcome of the events was reported as not recovered.     The reporter considered herpes zoster and ill-defined disorder to be related to Zoster Vaccine Live (ZOSTAVAX).
Age: 74.0
Sex: U
Vaccine: VARZOS
Symptoms: Herpes zoster
Clinical narrative: Shingles; Information has been received regarding a case in litigation from a lawyer referring to a currently 85 years old elderly patient of unknown gender. No information was provided regarding medical history, concurrent conditions, or concomitant medications. In or about 2011, the patient was vaccinated with zoster vaccine live (ZOSTAVAX) (strength, dose, route, lot# and expiration date unknown) at a Medical Center for the long-term prevention of shingles and zoster-related conditions. Subsequently, the patient was treated by a healthcare provider (HCP) for the following injury resulting from the patient's zoster vaccine live (ZOSTAVAX) use: shingles. The outcome of the event was unknown.
Sex: U
Vaccine: RV5
Symptoms: No adverse event, Product storage error
Clinical narrative: No additional AE reported; ROTATEQ that experienced a temperature excursion was administered to a patien; This spontaneous report was received from a physician referring to a patient of unknown age and gender. The patient's pertinent medical history, concomitant therapies and drug allergy or reactions were not reported.   On 18-OCT-2021, the patient was vaccinated with rotavirus vaccine, live, oral, pentavalent (ROTATEQ) 2 ml (lot # T040207, expiration date: 18-JUL-2022; strength was not reported) orally for prophylaxis that experienced a temperature excursion (product storage error).         The vaccine underwent temperature excursions of 33 Fahrenheit (F) for 15 minutes, 33 F for 10 minutes and 33 F for 5 seconds. The previous temperature excursions were not applicable. No additional adverse events were reported (no adverse event).
Sex: U
Vaccine: PPV
Symptoms: No adverse event, Product storage error
Clinical narrative: No further information was provided.; temperature excursion that occurred on 10/11/2021 with PNEUMOVAX 23; This spontaneous report was received from a nurse and refers to a patient of unknown age and gender. There was no information about the patient's concurrent conditions, concomitant therapies or medical history provided.  On 13-OCT-2021, the patient was vaccinated with improperly stored dose of pneumococcal vaccine, polyvalent (23-valent) (PNEUMOVAX23) lot # T039322, expiration date 09-SEP-2022 (dose, route of administration and anatomical location were not provided) for prophylaxis. Administered vaccine experienced temperature excursion of 23.9 degrees Celsius for 31 minutes on 11-OCT-2021. There were no previous excursions reported. No additional adverse event was reported.
Sex: F
Vaccine: HPV4, HPV9
Symptoms: Exposure during pregnancy
Clinical narrative: a pregnant patient received the HPV vaccine; This spontaneous prospective pregnancy report was received from a registered nurse referring to a female patient of unknown age. The patient's concurrent conditions, medical history, and concomitant medications were not reported.  On an unknown date, the patient was vaccinated with hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast)(GARDASIL 9) or quadrivalent human papillomavirus (types 6,11,16,18) recomb. vaccine(GARDASIL) for prophylaxis (strength, dose, frequency, route of administration, lot #, and expiration date were not reported).       The patient became pregnant on an unknown date. The last menstrual period (LMP) and estimated date of delivery (EDD) were not known. The pregnancy outcome was outcome pending. On an unknown date, the patient received the hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast)(manufacturer unknown) being pregnant (exposure during pregnancy).
Age: 56.0
Sex: F
Vaccine: VARZOS
Symptoms: Blood pressure increased, Hypoaesthesia
Clinical narrative: forearm went completely numb as well as the right side of my face; blood pressure also went up; This case was reported by a consumer and described the occurrence of numbness of upper extremities in a 56-year-old female patient who received Herpes zoster (Shingrix) (batch number HM21H, expiry date unknown) for prophylaxis.   Concurrent medical conditions included osteoporosis and food allergy (allergic to sesame seed).   On 8th October 2021, the patient received Shingrix .5 ml. On 8th October 2021, immediately after receiving Shingrix, the patient experienced numbness of upper extremities and increased blood pressure. On an unknown date, the outcome of the numbness of upper extremities and increased blood pressure were recovered/resolved.   It was unknown if the reporter considered the numbness of upper extremities and increased blood pressure to be related to Shingrix.  Additional details were provided as follows: The patient self-reported this case. The patient received Shingrix vaccine and within 3 minutes of receiving the shot, her forearm went completely numb as well as the right side of her face including my ear (on same side where the shot was administered) and her blood pressure also went up. The reporter stated that the nurse called it an unusual and immediate reaction to Shingrix. The patient reported that everything went back to normal within 30 minutes.
Sex: F
Vaccine: VARZOS
Symptoms: Herpes zoster, Illness, Neuralgia, Pain
Clinical narrative: worst situation of the sickness (shingles); SICKNESS; nerve pain, 8 months ago; pain; This case was reported by a consumer via interactive digital media and described the occurrence of shingles 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, less than a week after receiving Shingles vaccine, the patient experienced shingles, sickness, nerve pain and pain. On an unknown date, the outcome of the shingles and sickness were recovered/resolved and the outcome of the nerve pain and pain were not recovered/not resolved.   It was unknown if the reporter considered the shingles, sickness, nerve pain and pain to be related to Shingles vaccine.  Additional details were provided as follows: The patient was the reporter's mother-in-law. The age at vaccination was not reported. The patient received the Shingles vaccine and in one week got the worst situation of the sickness (shingles). Now she was suffering with nerve pain in her whole body. It happened 8 months ago but the pain was still there and was bad. The reporter stated to be careful with vaccines and more in these times when lots of 50 plus were dying in the hospitals.
Age: 63.0
Sex: F
Vaccine: VARZOS
Symptoms: Herpes zoster, Inappropriate schedule of product administration, Vaccination failure
Clinical narrative: Suspected vaccination failure; Shingles; first dose on 07/18/2018, second dose on 10/12/2019; This case was reported by a consumer via call center representative and described the occurrence of suspected vaccination failure in a 64-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   Co-suspect products included Herpes zoster (Shingrix) for prophylaxis.   On 12th October 2019, the patient received the 2nd dose of Shingrix. On 18th July 2018, the patient received the 1st dose of Shingrix. On 12th October 2019, unknown after receiving Shingrix and not applicable after receiving Shingrix, the patient experienced drug dose administration interval too long. In February 2020, the patient experienced vaccination failure (serious criteria GSK medically significant) and shingles. On an unknown date, the outcome of the vaccination failure and drug dose administration interval too long were unknown and the outcome of the shingles was recovered/resolved.   It was unknown if the reporter considered the vaccination failure and shingles to be related to Shingrix and Shingrix.  Additional details were provided as follows: This case was reported by the patient. The patient received 2nd dose of Shingrix late than the recommended schedule, which led to lengthening of vaccination schedule. This case was considered to be a suspected vaccination failure case, as the details regarding laboratory confirmation for shingles was unknown. The reporter consented to follow up and provided phone number for healthcare professional (HCP) reference. For another occurrence of shingles in 2021 refer linked case US2021213520, reported by same reporter.; Sender's Comments:  US-GLAXOSMITHKLINE-US2021213520:same reporter
Sex: U
Vaccine: VARZOS
Symptoms: Fatigue, Nausea, Pyrexia
Clinical narrative: nausea; fever; tiredness; This case was reported by a consumer via (Shingrix GSK Chatbot) interactive digital media and described the occurrence of nausea in a patient who received Herpes zoster (Shingrix) for prophylaxis.   On an unknown date, the patient received the 2nd dose of Shingrix. On an unknown date, unknown after receiving Shingrix, the patient experienced nausea, fever and tiredness. On an unknown date, the outcome of the nausea, fever and tiredness were unknown.   It was unknown if the reporter considered the nausea, fever and tiredness to be related to Shingrix.   Additional details were reported as follows: The case was reported by the patient. The age at vaccination was not reported. The patient experiencing fever, tiredness nausea. The reporter asked how long could he/she expect adverse reactions to Shingrix 2 vaccine to last. No contact details were reported.
Sex: U
Vaccine: VARZOS
Symptoms: Pain, Swelling
Clinical narrative: Pain; swelling; This case was reported by a consumer via call center representative and described the occurrence of pain in a 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 and swelling. On an unknown date, the outcome of the pain and swelling were recovered/resolved.   It was unknown if the reporter considered the pain and swelling to be related to Shingrix.  Additional details were provided as follows: The age at vaccination was not reported. The pain and swelling lasting over a week.  The patient asked if this an allergic reaction. The patient did not want again when go for the second shot.
Sex: U
Vaccine: VARZOS
Symptoms: Inappropriate schedule of product administration
Clinical narrative: My 2 does were 1 year apart.; This case was reported by a consumer via (Shingrix GSK Chatbot) interactive digital media and described the occurrence of drug dose administration interval too long in a patient who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included Shingrix (received 1st dose 1 year apart from the 2nd dose ).   On an unknown date, the patient received the 2nd dose of Shingrix. On an unknown date, unknown after receiving Shingrix, the patient experienced drug dose administration interval too long. On an unknown date, the outcome of the drug dose administration interval too long was unknown.  Additional details were provided as follows: The reporter was the patient. The age at vaccination was not reported. The patient received 2nd dose of Shingrix later than the recommended time interval, which led to lengthening of vaccination schedule. The patient asked did this provide immunity.
Sex: U
Vaccine: VARZOS
Symptoms: Inappropriate schedule of product administration
Clinical narrative: does were 1 year apart; This case was reported by a consumer via call center representative and described the occurrence of drug dose administration interval too long in a 54-year-old patient who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included Shingrix (received 1st dose 1 year apart from 2nd dose ).   On an unknown date, the patient received the 2nd dose of Shingrix. On an unknown date, unknown after receiving Shingrix, the patient experienced drug dose administration interval too long. On an unknown date, the outcome of the drug dose administration interval too long was unknown.  Additional details were provided as follows: The reporter was the patient. The age at vaccination was not reported. The patient received 2nd dose of Shingrix later than the recommended time interval, which led to lengthening of vaccination schedule. The patient asked if his or her immunity fine.
Sex: U
Vaccine: FLUX
Symptoms: Illness
Clinical narrative: severely sick; This case was reported by a consumer via social media interactive digital media and described the occurrence of sickness in a 4-year-old patient who received Flu Seasonal QIV Dresden (Influenza vaccine Quadrivalent unspecified season) for prophylaxis.   On an unknown date, the patient received Influenza vaccine Quadrivalent unspecified season. On an unknown date, unknown after receiving Influenza vaccine Quadrivalent unspecified season, the patient experienced sickness. On an unknown date, the outcome of the sickness was unknown.   It was unknown if the reporter considered the sickness to be related to Influenza vaccine Quadrivalent unspecified season.  Additional details were provided as follows: This case was reported by the patient's parent. The age at vaccination was not reported. The patient had got the flu shot and got severely sick. This case was liked with US2021AMR216445, reported by the same reporter.; Sender's Comments:  US-GLAXOSMITHKLINE-US2021AMR216445:same reporter
Sex: U
Vaccine: VARZOS
Symptoms: Malaise
Clinical narrative: out for the count; This case was reported by a consumer and described the occurrence of unwell in a patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   On an unknown date, the patient received the 1st dose of Shingles vaccine. On an unknown date, 1 day after receiving Shingles vaccine, the patient experienced unwell. On an unknown date, the outcome of the unwell was unknown.   It was unknown if the reporter considered the unwell to be related to Shingles vaccine.  Additional details were provided as follows: The patient self-reported this case. The age at vaccination was not reported. The patient received dose of Shingles vaccine and he/she was out for the count the next day. The patient stated that it was better than having Shingles. The patient also stated that this too shall pass. The patient's 2nd shingles shot was scheduled for next Tuesday from the day of reporting. The follow-up would not possible as no contact details were available.
Sex: M
Vaccine: VARZOS
Symptoms: Herpes zoster, Vaccination failure
Clinical narrative: took both shots and come down shingles/ suspected vaccination failure; shingles; This case was reported by a consumer via interactive digital media and described the occurrence of suspected vaccination failure in a male patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   Co-suspect products included Herpes zoster (Shingles vaccine) for prophylaxis.   On an unknown date, the patient received the 2nd dose of Shingles vaccine and the 1st dose of Shingles vaccine. On an unknown date, unknown after receiving Shingles vaccine and Shingles vaccine, the patient experienced vaccination failure (serious criteria GSK medically significant) and shingles. On an unknown date, the outcome of the vaccination failure was unknown and the outcome of the shingles was not recovered/not resolved.   It was unknown if the reporter considered the vaccination failure and shingles to be related to Shingles vaccine and Shingles vaccine.  Additional details were provided as follows: The patient was reporter's son. The age at vaccination was not reported. The patient received both Shingles shots and has now came down with shingles. This case was considered to be a suspected vaccination failure case, as the details regarding laboratory confirmation for shingles and time to onset were unknown.
Sex: U
Vaccine: VARZOS
Symptoms: Herpes zoster, Vaccination failure
Clinical narrative: Got the shingles shot. Then got shingles/ suspected vaccination failure; shingles; This case was reported by a consumer via interactive digital media and described the occurrence of suspected vaccination failure in a patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   The patient's past medical history included chickenpox (had as a kid).   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 patient was reporter's son. The age at vaccination was not reported. The patient received the Shingles shot and then got shingles. The reporter stated no extra stress. This case was considered to be a suspected vaccination failure case, as the details regarding completion of primary vaccination schedule, laboratory confirmation for shingles and time to onset were unknown.
Sex: F
Vaccine: VARZOS
Symptoms: Eye pain, Facial pain, Herpes zoster, Rash, Vaccination failure
Clinical narrative: Shingles, 3 month after I got the shot/ suspected vaccination failure; bad case of Shingles, came down with it with a bang; 3 years of awful rash on the whole right side of my face eye; 3 years of awful pain on the whole right side of my face eye. able to keep right eye open now; 3 years of awful pain on the whole right side of my face eye. able to keep right eye open now; This case was reported by a consumer via interactive digital media and described the occurrence of suspected vaccination failure 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, 3 months after receiving Shingles vaccine, the patient experienced vaccination failure (serious criteria GSK medically significant), shingles, rash, eye pain and facial pain. On an unknown date, the outcome of the vaccination failure and shingles were unknown and the outcome of the rash, eye pain and facial pain were recovering/resolving.   It was unknown if the reporter considered the vaccination failure, shingles, rash, eye pain and facial pain to be related to Shingles vaccine.  Additional details were provided as follows: This case was reported by the patient. The age at vaccination was not reported. The patient developed a bad case of Shingles 3 month after receiving the Shingles shot. The patient was just getting to a low pain level with it after 3 years of awful rash and pain on the whole right side of her face and eye. The patient was able to keep right eye open at the time of reporting and stated that it has improved a lot on the reporting month. The patient came down with shingles with a bang when she lost her husband of 68 years with a heart attack. This case was considered to be a suspected vaccination failure case, as the details regarding completion of primary vaccination schedule and laboratory confirmation for shingles were unknown.
Sex: U
Vaccine: HIBV
Symptoms: Incorrect dose administered, Product preparation error
Clinical narrative: reconstituted with Saline water and administered; reconstituted with Saline water and administered; This case was reported by a nurse via call center representative and described the occurrence of wrong solution used in drug reconstitution in a patient who received Hib (Hiberix) for prophylaxis.   On 12th October 2021, the patient received Hiberix. On 12th October 2021, unknown after receiving Hiberix, the patient experienced wrong solution used in drug reconstitution and inappropriate dose of vaccine administered. On an unknown date, the outcome of the wrong solution used in drug reconstitution and inappropriate dose of vaccine administered were unknown.  Additional details were provided as follows: The age at vaccination was not provided. The reporter was aware of Hiberix is a solution for injection supplied as a single-dose vial of lyophilized vaccine to be reconstituted with the accompanying vial of saline diluent. However, the powder was reconstituted with Saline water and the vaccine was administered to a patient, which led to wrong solution used in drug reconstitution and inappropriate dose of vaccine administered. The reporter did not have patient information neither lot number/expiration date available in that moment. The reporter consented to follow up.
Age: 17.0
Sex: M
Vaccine: MNQ
Symptoms: Expired product administered
Clinical narrative: Expired Menveo was given; This case was reported by a nurse via call center representative and described the occurrence of expired vaccine used in a 17-year-old male patient who received Men ACWY-CRM NVS (Menveo) (batch number AMVA417A, expiry date 30th September 2021) for prophylaxis.   On 13th October 2021, the patient received Menveo. On 13th October 2021, unknown after receiving Menveo, 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, an expired Menveo vaccine was given on the day of reporting to the patient, which led to expired vaccine used. The reporter asked if the vaccine given today was  viable and If not, when could the patient receive another one. The reporter agreed to follow up via email.