chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Sex: M
Vaccine: FLU3, FLU3, FLU3
Symptoms: Transient ischaemic attack, Troponin, Type IIa hyperlipidaemia, Ultrasound breast, Ultrasound chest
Clinical narrative: inflammation in chest and constant chest pain 24 by 7; stroke; Initial information received on 14-Sep-2020 regarding an unsolicited valid serious case received from a consumer or non-healthcare professional (patient).  This case is linked to cases 2019SA309818 (same reporter).  This case involves a 70-years-old male patient who experienced inflammation in chest with constant chest pain 24 by 7 (chest pain) and stroke (cerebrovascular accident) while he received INFLUENZA QUADRIVAL A-B MULTIDOSE VACCINE PRESERVED [FLUZONE].  The patient's medical history, past medical treatment, vaccination, concomitant medication and family history were not provided.   In September 2019, the patient received a dose of suspect INFLUENZA QUADRIVAL A-B MULTIDOSE VACCINE PRESERVED (lot number UJ25388 and expiry date not reported) via an unknown route at unknown administration site for prophylactic vaccination.  In Feb-2020, the patient developed a serious stroke (cerebrovascular accident) (the most recent stroke was in September 10-12, 2020) unknown latency following the administration of INFLUENZA QUADRIVAL A-B MULTIDOSE VACCINE PRESERVED. This event was assessed as medically significant.   On an unknown date, the patient developed a serious inflammation in chest with constant chest pain 24 by 7 (chest pain) unknown latency following the administration of INFLUENZA QUADRIVAL A-B MULTIDOSE VACCINE PRESERVED.  Also he had repeated trips to the hospital and the patient was hospitalized for these events.  Laboratory details were not reported.  It was not reported if the patient received a corrective treatment.  The outcome of events was unknown.; Sender's Comments: A 70-years-old male patient who presented with inflammation in chest with pain and cerebrovascular accident unknown latency following the vaccination with FLUZONE. Time to onset is compatible for stroke and unknown for chest pathology. Medical history, concomitant medication, precise etiological diagnosis and lab data ruling out alternative etiologies would be needed for complete assessment of the case. Based upon the reported information, role the vaccine cannot be assessed.
Sex: M
Vaccine: FLU3, FLU3, FLU3
Symptoms: Vaccination complication, X-ray
Clinical narrative: inflammation in chest and constant chest pain 24 by 7; stroke; Initial information received on 14-Sep-2020 regarding an unsolicited valid serious case received from a consumer or non-healthcare professional (patient).  This case is linked to cases 2019SA309818 (same reporter).  This case involves a 70-years-old male patient who experienced inflammation in chest with constant chest pain 24 by 7 (chest pain) and stroke (cerebrovascular accident) while he received INFLUENZA QUADRIVAL A-B MULTIDOSE VACCINE PRESERVED [FLUZONE].  The patient's medical history, past medical treatment, vaccination, concomitant medication and family history were not provided.   In September 2019, the patient received a dose of suspect INFLUENZA QUADRIVAL A-B MULTIDOSE VACCINE PRESERVED (lot number UJ25388 and expiry date not reported) via an unknown route at unknown administration site for prophylactic vaccination.  In Feb-2020, the patient developed a serious stroke (cerebrovascular accident) (the most recent stroke was in September 10-12, 2020) unknown latency following the administration of INFLUENZA QUADRIVAL A-B MULTIDOSE VACCINE PRESERVED. This event was assessed as medically significant.   On an unknown date, the patient developed a serious inflammation in chest with constant chest pain 24 by 7 (chest pain) unknown latency following the administration of INFLUENZA QUADRIVAL A-B MULTIDOSE VACCINE PRESERVED.  Also he had repeated trips to the hospital and the patient was hospitalized for these events.  Laboratory details were not reported.  It was not reported if the patient received a corrective treatment.  The outcome of events was unknown.; Sender's Comments: A 70-years-old male patient who presented with inflammation in chest with pain and cerebrovascular accident unknown latency following the vaccination with FLUZONE. Time to onset is compatible for stroke and unknown for chest pathology. Medical history, concomitant medication, precise etiological diagnosis and lab data ruling out alternative etiologies would be needed for complete assessment of the case. Based upon the reported information, role the vaccine cannot be assessed.
Sex: M
Vaccine: FLU3, FLU3, FLU3
Symptoms: Cerebrovascular accident, Chest pain, Inflammation
Clinical narrative: inflammation in chest and constant chest pain 24 by 7; stroke; Initial information received on 14-Sep-2020 regarding an unsolicited valid serious case received from a consumer or non-healthcare professional (patient).  This case is linked to cases 2019SA309818 (same reporter).  This case involves a 70-years-old male patient who experienced inflammation in chest with constant chest pain 24 by 7 (chest pain) and stroke (cerebrovascular accident) while he received INFLUENZA QUADRIVAL A-B MULTIDOSE VACCINE PRESERVED [FLUZONE].  The patient's medical history, past medical treatment, vaccination, concomitant medication and family history were not provided.   In September 2019, the patient received a dose of suspect INFLUENZA QUADRIVAL A-B MULTIDOSE VACCINE PRESERVED (lot number UJ25388 and expiry date not reported) via an unknown route at unknown administration site for prophylactic vaccination.  In Feb-2020, the patient developed a serious stroke (cerebrovascular accident) (the most recent stroke was in September 10-12, 2020) unknown latency following the administration of INFLUENZA QUADRIVAL A-B MULTIDOSE VACCINE PRESERVED. This event was assessed as medically significant.   On an unknown date, the patient developed a serious inflammation in chest with constant chest pain 24 by 7 (chest pain) unknown latency following the administration of INFLUENZA QUADRIVAL A-B MULTIDOSE VACCINE PRESERVED.  Also he had repeated trips to the hospital and the patient was hospitalized for these events.  Laboratory details were not reported.  It was not reported if the patient received a corrective treatment.  The outcome of events was unknown.; Sender's Comments: A 70-years-old male patient who presented with inflammation in chest with pain and cerebrovascular accident unknown latency following the vaccination with FLUZONE. Time to onset is compatible for stroke and unknown for chest pathology. Medical history, concomitant medication, precise etiological diagnosis and lab data ruling out alternative etiologies would be needed for complete assessment of the case. Based upon the reported information, role the vaccine cannot be assessed.
Age: 19.0
Sex: F
Vaccine: IPV, IPV
Symptoms: Wrong product administered
Clinical narrative: a 14 weeks pregnant patient received a dose of IPOL, No AE; A patient came in for a Tuberculin skin test and the vaccine used was IPOL, No AE; Initial information received on 31-Aug-2020 regarding an unsolicited valid non-serious case received from the other health care professional.  This case involves a 19 years old female patient who received a dose of POLIOMYELITIS VACCINE (INACTIVATED) (IPV) (VERO) [IPOL] instead of TUBERCULIN TEST [TUBERSOL] (wrong product administered) while she was pregnant.  Data regarding this pregnancy were received prospectively.  Medication error occurred while she was 14 weeks pregnant.  The date of last menstrual period was not reported.  The estimated due date was not reported.  Medical history, medical treatment, concomitant medication, vaccination and family history were not provided.  On 31-Aug-2020, the patient received a 0.1 ml dose of suspect IPV (VERO) (lot P1F49 and expiry date: 30-Nov-2020) via an intradermal route in the left forearm for prophylactic vaccination.  It was a case of vaccine exposure during pregnancy and also an actual medication error due to wrong vaccine administered (same day latency).  Pregnancy outcome was unknown at the time of report.  This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holder's compliance with the requirements set out in Directive 2001/83/EC and Module VI of the Good Pharmacovigilance Practices. The classification as a medical error is in no way intended, nor should it be interpreted or construed as an allegation or claim made by the marketing authorization holder that any third party has contributed to or is to be held liable for the occurrence of this medication error.
Age: 44.0
Sex: M
Vaccine: DTAP, TDAP
Symptoms: Blood test, Chest X-ray, Computerised tomogram, Electrocardiogram, Lumbar puncture
Clinical narrative: was a completely healthy 45 yo male. I went for a checkup with my primary care doctor who encouraged me to get a tetanus/diptheria/pertussis shot on 6/11/2020. I was admitted to the hospital on 6/21/2020 and diagnosed with transverse myelitis. I was not able to walk, urinate, or move my bowels. I was hospitalized for 10 days requiring heavy steroid and plasma exchange therapy. I am continuing to recover but have daily struggles with fatigue, clearing my lungs, tingling, and weakness. I am now under the treatment of neurologist and urologist. I tested negative for COVID-19 and antibody. I was never sick the entire cold and flu season. I had no pre-existing conditions. I do have the information for the DTAP vaccine-Sanofi Pasteur manufactured, given 0.5ml in left arm. I am curious if there is a correlation to the new COVID vaccine study halt. Is it a new preservative in the vaccines or is it the virus that caused myelitis in myself and woman in the study.
Age: 44.0
Sex: M
Vaccine: DTAP, TDAP
Symptoms: Magnetic resonance imaging, Myelitis transverse, Plasmapheresis
Clinical narrative: was a completely healthy 45 yo male. I went for a checkup with my primary care doctor who encouraged me to get a tetanus/diptheria/pertussis shot on 6/11/2020. I was admitted to the hospital on 6/21/2020 and diagnosed with transverse myelitis. I was not able to walk, urinate, or move my bowels. I was hospitalized for 10 days requiring heavy steroid and plasma exchange therapy. I am continuing to recover but have daily struggles with fatigue, clearing my lungs, tingling, and weakness. I am now under the treatment of neurologist and urologist. I tested negative for COVID-19 and antibody. I was never sick the entire cold and flu season. I had no pre-existing conditions. I do have the information for the DTAP vaccine-Sanofi Pasteur manufactured, given 0.5ml in left arm. I am curious if there is a correlation to the new COVID vaccine study halt. Is it a new preservative in the vaccines or is it the virus that caused myelitis in myself and woman in the study.
Age: 44.0
Sex: M
Vaccine: DTAP, TDAP
Symptoms: Asthenia, Constipation, Fatigue, Gait inability, Myelitis transverse
Clinical narrative: was a completely healthy 45 yo male. I went for a checkup with my primary care doctor who encouraged me to get a tetanus/diptheria/pertussis shot on 6/11/2020. I was admitted to the hospital on 6/21/2020 and diagnosed with transverse myelitis. I was not able to walk, urinate, or move my bowels. I was hospitalized for 10 days requiring heavy steroid and plasma exchange therapy. I am continuing to recover but have daily struggles with fatigue, clearing my lungs, tingling, and weakness. I am now under the treatment of neurologist and urologist. I tested negative for COVID-19 and antibody. I was never sick the entire cold and flu season. I had no pre-existing conditions. I do have the information for the DTAP vaccine-Sanofi Pasteur manufactured, given 0.5ml in left arm. I am curious if there is a correlation to the new COVID vaccine study halt. Is it a new preservative in the vaccines or is it the virus that caused myelitis in myself and woman in the study.
Age: 44.0
Sex: M
Vaccine: DTAP, TDAP
Symptoms: Paraesthesia, Plasmapheresis, Pulmonary congestion, SARS-CoV-2 antibody test negative, SARS-CoV-2 test negative
Clinical narrative: was a completely healthy 45 yo male. I went for a checkup with my primary care doctor who encouraged me to get a tetanus/diptheria/pertussis shot on 6/11/2020. I was admitted to the hospital on 6/21/2020 and diagnosed with transverse myelitis. I was not able to walk, urinate, or move my bowels. I was hospitalized for 10 days requiring heavy steroid and plasma exchange therapy. I am continuing to recover but have daily struggles with fatigue, clearing my lungs, tingling, and weakness. I am now under the treatment of neurologist and urologist. I tested negative for COVID-19 and antibody. I was never sick the entire cold and flu season. I had no pre-existing conditions. I do have the information for the DTAP vaccine-Sanofi Pasteur manufactured, given 0.5ml in left arm. I am curious if there is a correlation to the new COVID vaccine study halt. Is it a new preservative in the vaccines or is it the virus that caused myelitis in myself and woman in the study.
Age: 44.0
Sex: M
Vaccine: DTAP, TDAP
Symptoms: Urinary retention
Clinical narrative: was a completely healthy 45 yo male. I went for a checkup with my primary care doctor who encouraged me to get a tetanus/diptheria/pertussis shot on 6/11/2020. I was admitted to the hospital on 6/21/2020 and diagnosed with transverse myelitis. I was not able to walk, urinate, or move my bowels. I was hospitalized for 10 days requiring heavy steroid and plasma exchange therapy. I am continuing to recover but have daily struggles with fatigue, clearing my lungs, tingling, and weakness. I am now under the treatment of neurologist and urologist. I tested negative for COVID-19 and antibody. I was never sick the entire cold and flu season. I had no pre-existing conditions. I do have the information for the DTAP vaccine-Sanofi Pasteur manufactured, given 0.5ml in left arm. I am curious if there is a correlation to the new COVID vaccine study halt. Is it a new preservative in the vaccines or is it the virus that caused myelitis in myself and woman in the study.
Age: 65.0
Sex: F
Vaccine: VARZOS, VARZOS
Symptoms: Erythema, Fatigue, Feeding disorder, Headache, Induration
Clinical narrative: within 18 hours (friday am) of injection, patient had a hard and sore area at sight of injection. later developing chills and a headache. 2 days (saturday)after experienced fatigue and area was large and warm at injection site.  patient describes as if she was stung by a bee; similar reaction. Patient took pain reliever, benadryl and applied hydrocortisone cream.
Age: 65.0
Sex: F
Vaccine: VARZOS, VARZOS
Symptoms: Loss of personal independence in daily activities, Nausea, Pain, Pain in extremity, Peripheral swelling
Clinical narrative: within 18 hours (friday am) of injection, patient had a hard and sore area at sight of injection. later developing chills and a headache. 2 days (saturday)after experienced fatigue and area was large and warm at injection site.  patient describes as if she was stung by a bee; similar reaction. Patient took pain reliever, benadryl and applied hydrocortisone cream.
Age: 65.0
Sex: F
Vaccine: VARZOS, VARZOS
Symptoms: Skin warm
Clinical narrative: within 18 hours (friday am) of injection, patient had a hard and sore area at sight of injection. later developing chills and a headache. 2 days (saturday)after experienced fatigue and area was large and warm at injection site.  patient describes as if she was stung by a bee; similar reaction. Patient took pain reliever, benadryl and applied hydrocortisone cream.
Age: 65.0
Sex: F
Vaccine: VARZOS, VARZOS
Symptoms: Chills, Fatigue, Headache, Injection site induration, Injection site pain
Clinical narrative: within 18 hours (friday am) of injection, patient had a hard and sore area at sight of injection. later developing chills and a headache. 2 days (saturday)after experienced fatigue and area was large and warm at injection site.  patient describes as if she was stung by a bee; similar reaction. Patient took pain reliever, benadryl and applied hydrocortisone cream.
Age: 65.0
Sex: F
Vaccine: VARZOS, VARZOS
Symptoms: Injection site swelling, Injection site warmth
Clinical narrative: within 18 hours (friday am) of injection, patient had a hard and sore area at sight of injection. later developing chills and a headache. 2 days (saturday)after experienced fatigue and area was large and warm at injection site.  patient describes as if she was stung by a bee; similar reaction. Patient took pain reliever, benadryl and applied hydrocortisone cream.
Age: 59.0
Sex: M
Vaccine: VARZOS
Symptoms: Blister, Pain in extremity
Clinical narrative: reporting painful burn like blisters on right hand. manily thumb and ends of fingers. wife goes everywhere with him and they use the same hand sanitizers in home and in public
Age: 65.0
Sex: F
Vaccine: PPV, UNK, PPV
Symptoms: Body temperature increased, Chills, Decreased appetite, Fatigue, Headache
Clinical narrative: Began with body aches night of 9/16/20, awoke next morning with 100.3 degree temperature, severe headache, along with body aches, inability to move right arm without severe pain, large red rash at site of injection on right arm that was very hot and tender to touch, chills, sweating, nausea, loss of appetite, and fatigue.  All symptoms remained, though gradually subsided through 9/21/20.
Age: 65.0
Sex: F
Vaccine: PPV, UNK, PPV
Symptoms: Hyperhidrosis, Injection site pain, Injection site reaction, Injection site warmth, Mobility decreased
Clinical narrative: Began with body aches night of 9/16/20, awoke next morning with 100.3 degree temperature, severe headache, along with body aches, inability to move right arm without severe pain, large red rash at site of injection on right arm that was very hot and tender to touch, chills, sweating, nausea, loss of appetite, and fatigue.  All symptoms remained, though gradually subsided through 9/21/20.
Age: 65.0
Sex: F
Vaccine: PPV, UNK, PPV
Symptoms: Nausea, Pain, Rash erythematous
Clinical narrative: Began with body aches night of 9/16/20, awoke next morning with 100.3 degree temperature, severe headache, along with body aches, inability to move right arm without severe pain, large red rash at site of injection on right arm that was very hot and tender to touch, chills, sweating, nausea, loss of appetite, and fatigue.  All symptoms remained, though gradually subsided through 9/21/20.
Age: 65.0
Sex: F
Vaccine: PPV, UNK, PPV
Symptoms: Erythema, Pain in extremity, Peripheral swelling, Skin warm
Clinical narrative: Began with body aches night of 9/16/20, awoke next morning with 100.3 degree temperature, severe headache, along with body aches, inability to move right arm without severe pain, large red rash at site of injection on right arm that was very hot and tender to touch, chills, sweating, nausea, loss of appetite, and fatigue.  All symptoms remained, though gradually subsided through 9/21/20.
Age: 53.0
Sex: M
Vaccine: VARZOS
Symptoms: Back pain, Dizziness, Ear pain, Headache, Insomnia
Clinical narrative: headaches, earaches, body aches, fever 99.7 to 101.1, nausea, dizziness, rouble sleeping, back aches,
Age: 53.0
Sex: M
Vaccine: VARZOS
Symptoms: Nausea, Pain, Pyrexia
Clinical narrative: headaches, earaches, body aches, fever 99.7 to 101.1, nausea, dizziness, rouble sleeping, back aches,
Age: 68.0
Sex: M
Vaccine: FLU4
Symptoms: Injection site erythema, Injection site swelling
Clinical narrative: SWELLING AND REDNESS AT INJECTION SITE
Age: 1.0
Sex: M
Vaccine: MMR
Symptoms: Febrile convulsion
Clinical narrative: febrile seizure
Age: 72.0
Sex: F
Vaccine: PPV
Symptoms: Erythema, Injection site erythema, Injection site warmth, Skin warm
Clinical narrative: Patient came to me 2 days after the shot with her arm red and warm. but not at the injection site, but around the arm.  I told her to go to doctor that it looked like cellulitis, an infection.
Age: 66.0
Sex: M
Vaccine: FLU4
Symptoms: Back pain, Dizziness, Feeling abnormal, Flank pain, Grip strength decreased
Clinical narrative: I was fine until later that evening when I started feeling just a bit off.  The next day I was sick and it continued for three days.  On the third day I started getting dizzy and was dizzy through the afternoon into the evening.  The next morning I felt fine but noticed a twinge in the middle of my back.  That twinge grew to significant pain and has migrated from my back to my sides and is significant enough that I cannot hold a coffee cup.  I am also getting headaches that come and go.  The headache will last a few minutes then go away.  Shortly thereafter I get another one an I never get headaches.  I CANNOT  attribute this to anything other than the flu shot.
Age: 66.0
Sex: M
Vaccine: FLU4
Symptoms: Headache, Malaise, Musculoskeletal discomfort
Clinical narrative: I was fine until later that evening when I started feeling just a bit off.  The next day I was sick and it continued for three days.  On the third day I started getting dizzy and was dizzy through the afternoon into the evening.  The next morning I felt fine but noticed a twinge in the middle of my back.  That twinge grew to significant pain and has migrated from my back to my sides and is significant enough that I cannot hold a coffee cup.  I am also getting headaches that come and go.  The headache will last a few minutes then go away.  Shortly thereafter I get another one an I never get headaches.  I CANNOT  attribute this to anything other than the flu shot.
Age: 52.0
Sex: F
Vaccine: VARZOS
Symptoms: Pruritus, Swelling, Tenderness
Clinical narrative: LOCALIZED SWELLING WITH ITCHING, TENDERNESS GROWING IN SIZE
Age: 45.0
Sex: F
Vaccine: PPV
Symptoms: Pain, Pyrexia, Swelling
Clinical narrative: large local reaction with pain and swelling, fever to 102
Age: 53.0
Sex: M
Vaccine: UNK
Symptoms: Arthralgia, Injection site erythema, Injection site induration, Injection site swelling, Injection site warmth
Clinical narrative: Standard influenza shot caused severe, nearly disabling  muscle and joint pain starting about 30 hours after injection. Injection site red, swollen, hot and hard.
Age: 53.0
Sex: M
Vaccine: UNK
Symptoms: Myalgia
Clinical narrative: Standard influenza shot caused severe, nearly disabling  muscle and joint pain starting about 30 hours after injection. Injection site red, swollen, hot and hard.
Age: 30.0
Sex: F
Vaccine: FLUA4
Symptoms: Body temperature increased, Chest discomfort, Cough, Decreased appetite, Dizziness
Clinical narrative: *I AM UNSURE OF FLU INJECTION TYPE* all I know is I got the injected flu vaccine in my upper left arm  2:00pm - dizziness, general malaise, minor chest tightness, lack of appetite; decide to leave work for the day 2:30pm - arrive home, temp 98.6, begin increased water intake 3:00pm - take lactium (dose 234mg in case of anxiety attack, covid is still a thing and I'm afraid of getting it) & zyrtec (standard dose); temp 99.3, minor coughing (with phlegm), moderate body aches, previous symptoms continue (except chest tightness begins to decrease) 4:00pm - previous symptoms continue, added runny nose and stuffiness, hoarseness, nausea, temp sustained 99.3 6:00pm - coughing subsides, chest tightness subsides, all other symptoms continue 7:30pm - realize I haven't eaten since 7:30am, eat something (thanks ADHD) 8:00pm - all symptoms excluding body aches, runny/stuffy nose, and malaise have subsided; took two benadryl (total 50mg dose), fall asleep -- 8:00am, next morning - wake up, no symptoms besides soreness at injection sight and caffeine withdrawal headache
Age: 30.0
Sex: F
Vaccine: FLUA4
Symptoms: Drug withdrawal headache, Dysphonia, Impaired work ability, Injection site pain, Malaise
Clinical narrative: *I AM UNSURE OF FLU INJECTION TYPE* all I know is I got the injected flu vaccine in my upper left arm  2:00pm - dizziness, general malaise, minor chest tightness, lack of appetite; decide to leave work for the day 2:30pm - arrive home, temp 98.6, begin increased water intake 3:00pm - take lactium (dose 234mg in case of anxiety attack, covid is still a thing and I'm afraid of getting it) & zyrtec (standard dose); temp 99.3, minor coughing (with phlegm), moderate body aches, previous symptoms continue (except chest tightness begins to decrease) 4:00pm - previous symptoms continue, added runny nose and stuffiness, hoarseness, nausea, temp sustained 99.3 6:00pm - coughing subsides, chest tightness subsides, all other symptoms continue 7:30pm - realize I haven't eaten since 7:30am, eat something (thanks ADHD) 8:00pm - all symptoms excluding body aches, runny/stuffy nose, and malaise have subsided; took two benadryl (total 50mg dose), fall asleep -- 8:00am, next morning - wake up, no symptoms besides soreness at injection sight and caffeine withdrawal headache
Age: 30.0
Sex: F
Vaccine: FLUA4
Symptoms: Nasal congestion, Nausea, Pain, Rhinorrhoea
Clinical narrative: *I AM UNSURE OF FLU INJECTION TYPE* all I know is I got the injected flu vaccine in my upper left arm  2:00pm - dizziness, general malaise, minor chest tightness, lack of appetite; decide to leave work for the day 2:30pm - arrive home, temp 98.6, begin increased water intake 3:00pm - take lactium (dose 234mg in case of anxiety attack, covid is still a thing and I'm afraid of getting it) & zyrtec (standard dose); temp 99.3, minor coughing (with phlegm), moderate body aches, previous symptoms continue (except chest tightness begins to decrease) 4:00pm - previous symptoms continue, added runny nose and stuffiness, hoarseness, nausea, temp sustained 99.3 6:00pm - coughing subsides, chest tightness subsides, all other symptoms continue 7:30pm - realize I haven't eaten since 7:30am, eat something (thanks ADHD) 8:00pm - all symptoms excluding body aches, runny/stuffy nose, and malaise have subsided; took two benadryl (total 50mg dose), fall asleep -- 8:00am, next morning - wake up, no symptoms besides soreness at injection sight and caffeine withdrawal headache
Age: 1.25
Sex: F
Vaccine: DTAP
Symptoms: Unevaluable event
Clinical narrative: No symptoms at this moment.
Age: 52.0
Sex: F
Vaccine: VARZOS
Symptoms: Back pain, Injection site pain, Movement disorder
Clinical narrative: My left shoulder and upper back are killing me. I can?t move normally.
Age: 0.33
Sex: U
Vaccine: RV5
Symptoms: Inappropriate schedule of product administration
Clinical narrative: ROTATEQ after 15 weeks old(4 months old).; Information has been received from a nurse practitioner referring to a 4 months old patient. The patient's historical condition, concomitant medications and drug reactions or allergies were not reported.  On an unknown date, the patient was vaccinated with rotavirus vaccine, live, oral, pentavalent(ROTATEQ)(dose, frequency, route, lot # and expiration date were not reported) for prophylaxis(inappropriate schedule of product administration). Nurse Practitioner wanted to know if the patient should continue with the regimen or stop.
Age: 1.33
Sex: U
Vaccine: VARCEL
Symptoms: Product storage error
Clinical narrative: administration of improperly stored vaccines; This spontaneous report was received from a medical assistant referring to a 16-month-old patient of unknown gender. The patient's concurrent condition, medical history and allergic histories were not reported.  On 27-AUG-2020, the patient was vaccinated with improperly stored varicella virus vaccine live (oka/merck) (VARIVAX) 0.5ml (lot number was T002845, expiration date: 23-JAN-2022, dose strength and route were not applicable) for prophylaxis (Incorrect product storage)The vaccine was reconstituted with sterile diluent (lot# and expiration date were unknown by the reporter). The vaccine underwent temperature excursion of 6 degrees Fahrenheit to 14 degrees Fahrenheit (10.56 degrees Fahrenheit) for 50 minutes. There was previous temperature excursions of  6 degrees Fahrenheit to 14 degrees Fahrenheit (8.47 degrees Fahrenheit) for 30 minutes. The digital data logger was involved in recording excursion details. The outcome of incorrect product storage error was unknown.; Sender's Comments:  US-009507513-2009USA000777: US-009507513-2009USA000747:
Age: 4.0
Sex: U
Vaccine: MMRV
Symptoms: Expired product administered
Clinical narrative: Caller reported an expired diluent that was administered with PROQUAD.; This spontaneous report was received from a medical assistant referring to a 4-year-old patient of unknown gender. Information regarding the patient's pertinent medical history, concomitant medication and drug reactions/allergies was not provided.  On 24-AUG-2020, the patient was vaccinated with measles, mumps, rubella and varicella (oka-merck) virus vaccine live (rHA) (PROQUAD) (strength, dose, route were not reported; lot # S017255, expiration date 01-DEC-2020) reconstituted with an expired sterile diluent (MERCK STERILE DILUENT) (strength and dose were not reported; lot # S018821, expiration date 22-AUG-2020) for prophylaxis (expired product administered).
Sex: U
Vaccine: PPV
Symptoms: Incorrect dose administered, Needle issue, Poor quality device used, Syringe issue
Clinical narrative: needle stuck in patient's arm/ the needle came off remaining in the patients arm; Syringe broke during administrat ion of dose of Pneumovax, with vaccine contents splashing backwards; Syringe broke during administrat ion of dose of Pneumovax, with vaccine contents splashing backwards; the needle came off of the syringe; the needle came off remaining in the patients arm; This spontaneous report was received from a pharmacist referring to a patient of unknown age and gender. Information about medical history, concurrent conditions and concomitant therapies was not provided.   On 09-SEP-2020, the patient was vaccinated with pneumococcal vaccine, polyvalent (23-valent) (PNEUMOVAX23) (1 dose; strength, route, lot # and expiration date were not reported) for prophylaxis. During administration, syringe leaked where Luer Lok and the needle was attached and broke with vaccine contents splashing backwards, then the needle came off of the syringe while was stuck in patient's arm (remaining in the patients arm) (syringe issue, poor quality device used, injury associated with device, needle issue and incorrect dose administered). Product quality compliant involved. combinationproductreport: Yes; brandname: PNEUMOVAX23 SYRINGE (DEVICE); commondevicename: Pneumococcal Vaccine, Polyvalent (23-valent); productcode: FMF; devicetype: SYRINGE, PISTON (FMF); manufacturername: Merck Sharp & Dohme Corp.  deviceage and unit: 0 ; malfunction: Unknown; deviceusage: Initial; evaluatedbymfr: Not returned to manufacturer; reasonfornoneval: 81 Other; labeledsingleusedevice: No; mdcpreportability: No; mdcpreprationale: Case information does not meet the criteria for Reportability
Sex: U
Vaccine: PPV
Symptoms: No adverse event, Product storage error
Clinical narrative: No additional AE; improperly stored vaccine administration; This spontaneous report as received from a registered nurse refers to a patient of unknown age and gender. The patient's medical history and concurrent conditions were not reported. On 05-AUG-2020, the patient was vaccinated with a dose of improperly stored pneumococcal vaccine, polyvalent (23-valent) (PNEUMOVAX23) (lot# number reported as 031812 (not valid), expiry date: 26-SEP-2020, route of administration not reported). Temperature excursion was 30.7 degree of Fahrenheit through 15 minutes and subsequently 32 degree of Fahrenheit through 45 minutes. There was no previous temperature excursion. Temperature excursion was detected by Data Logger. No adverse event reported.
Age: 71.0
Sex: F
Vaccine: VARZOS
Symptoms: Herpes zoster, Varicella
Clinical narrative: chicken pox and/or shingles; chicken pox and/or shingles; Information has been received from a lawyer concerning a case in litigation and refers to a 71-year-old female patient. No information regarding the pt's medical history, concurrent conditions and concomitant medications was reported. On 13-JAN-2011, the pt was administered with zoster vaccine live (ZOSTAVAX) vaccine (dose, route of administration, vaccination site, lot # and expiry date were not specified) at the physician office for the long-term prevention of shingles and zoster-related conditions. As a result pf her receipt of zoster vaccine live (ZOSTAVAX), the pt was caused to suffer chicken pox and/or shingles in or about February 2011, including and all of it sequelae and subsequently was treated by a provider. As a result of her receipt of zoster vaccine live (ZOSTAVAX) , the pt has been caused to suffer severe personal injuries, pain, suffering, and emotional distress, as well as to incur substantial economic damages. As a direct and proximate result of zoster vaccine live (ZOSTAVAX)'s manufacturing defect, the pt suffered severe and permanent physical injuries, including but not limited to chicken pox and/or shingles, as well as other severe and permanent health consequences. The pt has endured substantial pain and suffering. The pt has incurred significant expenses for medical care and treatment, and will continue to incur such expenses in the future. The pt has lost past earnings and has suffered a loss of earning capacity. The pt  has suffered and would continue to suffer economic loss, and has otherwise been physically, emotionally and economically injured. The pt's injuries and damages ware permanent and would continue into the future. The pt sought actual and punitive damages from the Company as alleged herein. the pt demanded judgment against Company for compensatory, treble, and punitive damages, together with interest, costs of suit, attorneys' fees, and all such other relief as the Court deems proper. The outcome of the events was reported as not recovered. The causality was related.  The events of chicken pox and/or shingles were considered to be disabling.
Age: 64.0
Sex: F
Vaccine: VARZOS
Symptoms: Herpes zoster
Clinical narrative: shingles; This initial spontaneous report was received on from a lawyer regarding a case in litigation and refers to a 64-year-old female patient. The patient's concurrent conditions, medical history and concomitant medication were not provided.   In or about 2015, the patient was vaccinated with a dose zoster vaccine live (ZOSTAVAX) (dosage regimen was not reported) for the long-term prevention of shingles and/or zoster-related conditions.   In or about 2015, the patient presented shingles. As a direct and proximate result, the patient had been caused to suffer severe personal injuries, pain, suffering and emotional distress, as well as to incur substantial economic damages. As a direct and proximate result, she suffered severe and permanent physical injuries, including but not limited to shingles, as well as other severe and permanent health consequences; additionally, she had incurred significant expenses for medical care and treatment, her injuries and damages were permanent and would continue into the future.   The reporter considered the event of shingles to be related to zoster vaccine live (ZOSTAVAX).
Sex: U
Vaccine: PPV
Symptoms: Product storage error
Clinical narrative: PNEUMOVAX 23 that experienced an excursion was administered to a patient; This spontaneous report was received from a consumer referring to a patient of unknown age and gender. Information about medical history, concurrent conditions and concomitant therapies was not provided.       On 14-SEP-2020, the patient was vaccinated with pneumococcal vaccine, polyvalent (23-valent) (PNEUMOVAX23) (lot # reported as T00744 was evaluated and changed to the valid lot # T009744, expiration date 28-JAN-2022; strength, dose and route were not reported) that experienced an excursion for prophylaxis (product storage error). Temperature excursion was below 2 degree Celsius (1.7 degree Celsius) for 2 hours. There was no previous temperature excursion. Data logger was involved.        combinationproductreport: Yes; brandname: PNEUMOVAX23 SYRINGE (DEVICE); commondevicename: Pneumococcal Vaccine, Polyvalent (23-valent); productcode: FMF; devicetype: SYRINGE, PISTON (FMF); manufacturername: Merck Sharp & Dohme Corp.  devicelotnumber: T009744; expirationdate: 28-JAN-2022; deviceage and unit: 0 ; malfunction: Unknown; deviceusage: Initial; evaluatedbymfr: Not returned to manufacturer; reasonfornoneval: 81 Other; labeledsingleusedevice: No; mdcpreportability: No; mdcpreprationale: Case information does not meet the criteria for Reportability
Age: 58.0
Sex: F
Vaccine: VARZOS
Symptoms: Herpes zoster
Clinical narrative: shingles; inappropriate schedule of vaccine administered; Information has been received from a lawyer referring to a 58 years old female patient. Information about concurrent condition, history condition and concomitant medication was not reported. In November 2010 (conflict information, also reported as 01-FEB-2012), the patient was vaccinated with zoster vaccine live (ZOSTAVAX) (strength, dose, route, lot# and expiration date unknown) for the long-term prevention of shingles and zoster-related conditions (Inappropriate schedule of product administration). As a result of her receipt of zoster vaccine live (ZOSTAVAX), the patient was caused to suffer shingles in or about February 2011, including any and all of it sequelae. Subsequently, the patient was treated by a provider for the following injuries resulting from Zostavax (ZOSTAVAX): shingles. As a result of her receipt of zoster vaccine live (ZOSTAVAX), the patient has been caused to suffer severe personal injuries, pain, suffering and emotional distress, as well as to incur substantial economic damages. As a direct and proximate result of zoster vaccine live (ZOSTAVAX)'s defective design, the patient suffered severe and permanent physical injuries, including but not limited to shingles, as well as other severe and permanent health consequences. The patient has endured substantial pain and suffering, has incurred significant expenses for medical care and treatment, and will continue to incur such expenses in the future. The patient has lost past earning and has suffered a loss of earning capacity. The pt had suffered and will continue to suffer economic loss, and has otherwise been physically, emotionally and economically injured. The patient's injuries and damages are permanent and will continue into the future. The outcome of the event shingles was considered to be not recovered and causal relationship was assessed as related.    The lawyer considered the events shingles to be disability.
Age: 58.0
Sex: M
Vaccine: VARZOS
Symptoms: Facial paralysis
Clinical narrative: bell's palsy; Inappropriate schedule of vaccine administered; Information has been received from a lawyer referring to a 58 years old male patient. Information about concurrent condition, history condition and concomitant medication was not reported. On or about 03-MAR-2009 the patient was vaccinated with zoster vaccine live (ZOSTAVAX) (strength, dose, route, lot# and expiration date unknown) for the long-term prevention of shingles and zoster-related conditions (Inappropriate schedule of product administration). As a result of the receipt of zoster vaccine live (ZOSTAVAX), the patient was caused to suffer Bell's palsy on or about 04-MAR-2009, including any and all of it sequelae. Subsequently, the patient was treated by a provider for the following injuries resulting from Zostavax (ZOSTAVAX): Bell's palsy. As a result of the receipt of zoster vaccine live (ZOSTAVAX), the patient has been caused to suffer severe personal injuries, pain, suffering and emotional distress, as well as to incur substantial economic damages. As a direct and proximate result of zoster vaccine live (ZOSTAVAX)'s failure to warn, the patient suffered severe and permanent physical injuries, including but not limited to Bell's palsy, as well as other severe and permanent health consequences. The patient has endured substantial pain and suffering, has incurred significant expenses for medical care and treatment, and will continue to incur such expenses in the future. The patient has lost past earning and has suffered a loss of earning capacity. The pt had suffered and will continue to suffer economic loss, and has otherwise been physically, emotionally and economically injured. The patient's injuries and damages are permanent and will continue into the future. The outcome of the event Bell's palsy was considered to be not recovered and causal relationship was assessed as related.    The lawyer considered the events Bell's palsy to be disability.   Upon internal review, Bell's palsy was determined to be medically significant.
Age: 59.0
Sex: M
Vaccine: VARZOS
Symptoms: Chronic inflammatory demyelinating polyradiculoneuropathy
Clinical narrative: Chronic inflammatory demeylinating polyneuropathy; Information has been received from a lawyer referring to a 59 years old male patient. Information about concurrent condition, history condition and concomitant medication was not reported. In or about 2014, the patient was vaccinated with zoster vaccine live (ZOSTAVAX) (strength, dose, route, lot# and expiration date unknown) for the long-term prevention of shingles and zoster-related conditions. As a result of the receipt of zoster vaccine live (ZOSTAVAX), the patient was caused to suffer Chronic inflammatory demyelinating polyneuropathy (CIDP) in on or about 2014, including any and all of it sequelae. Subsequently, the patient was treated by a provider for the following injuries resulting from Zostavax (ZOSTAVAX): CIDP. As a result of the receipt of zoster vaccine live (ZOSTAVAX), the patient has been caused to suffer severe personal injuries, pain, suffering and emotional distress, as well as to incur substantial economic damages. As a direct and proximate result of zoster vaccine live (ZOSTAVAX)'s manufacturing defect, the patient suffered severe and permanent physical injuries, including but not limited to CIDP, as well as other severe and permanent health consequences. The patient has endured substantial pain and suffering, has incurred significant expenses for medical care and treatment, and will continue to incur such expenses in the future. The patient has lost past earning and has suffered a loss of earning capacity. The pt had suffered and will continue to suffer economic loss, and has otherwise been physically, emotionally and economically injured. The patient's injuries and damages are permanent and will continue into the future. The outcome of the event CIDP was considered to be not recovered and causal relationship was assessed as related.    The lawyer considered the events CIDP to be disability.   Upon internal review, CIDP was determined to be medically significant.
Age: 0.33
Sex: U
Vaccine: RV5
Symptoms: Product storage error
Clinical narrative: 3 patients reported on the document who received ROTATEQ after an excursion was reported/Temperature 48F Time frame 17 minutes; This spontaneous report was received from a medical assistant, referring to a patient of unknown age and gender. The patient's pertinent medical history, current conditions, previous drug reactions and allergies and concomitant medications were not reported.   On 01-JUL-2020, at the age of 4-months-old, the patient was vaccinated with rotavirus vaccine, live, oral, pentavalent (ROTATEQ), administered at a dose of 2 milliliters, by oral route (formulation, strength, vaccination scheme were not reported; lot number S004400, which has been verified to be valid, expiration date was not reported, but upon internal review was established as 14-NOV-2020) as prophylaxis. The vaccine administered experienced a temperature excursion of 48 degrees Fahrenheit for a time frame of 17 minutes, as recorded by a data logger (product storage error). There was no previous temperature excursion.   This is one of several reports received from the same reporter.; Sender's Comments:  US-009507513-2009USA006635: US-009507513-2009USA007900: US-009507513-2009USA007901:
Age: 0.5
Sex: U
Vaccine: HPV9
Symptoms: No adverse event, Product administered to patient of inappropriate age
Clinical narrative: No adverse event; GARDASIL 9 vaccine was inadvertently given to a 6 month infant; This spontaneous report was received from a Medical Assistant, referring to a 6 month old patient of an unspecified gender. Information regarding the patient's pertinent medical history, concurrent conditions, known allergies and concomitant medications were not provided.      In August 2020, the patient was inadvertently vaccinated with hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast) (GARDASIL 9) lot # R020200 with expiration date in 05-MAY-2021 (route of administration, strength and dose were not provided) for prophylaxis. No other adverse effect was reported. combinationproductreport: Yes; brandname: GARDASIL 9 SYRINGE (DEVICE); commondevicename: HPV rL1 6 11 16 18 31 33 45 52 58 VLP vaccine (yeast); productcode: FMF; devicetype: SYRINGE, PISTON (FMF); manufacturername: Merck Sharp & Dohme Corp.; devicelotnumber: R020200; expirationdate: 05-MAY-2021; deviceage and unit: 0 ; malfunction: Unknown; deviceusage: Initial; evaluatedbymfr: Not returned to manufacturer; reasonfornoneval: 81 Other; labeledsingleusedevice: No; mdcpreportability: No; mdcp rep rationale: Case information does not meet the criteria for Reportability
Age: 62.0
Sex: F
Vaccine: VARZOS
Symptoms: Herpes zoster
Clinical narrative: shingles; This initial spontaneous report was received from a lawyer regarding a case in litigation, concerning an approximately 62-year-old female patient (pt). No information was provided regarding medical history, concurrent conditions, or concomitant medications. On or about 29-MAY-2015, the pt was vaccinated in a physician office with zoster vaccine live (ZOSTAVAX) (lot#, expiration date, dose, dose #, anatomical location and route not specified) for the long-term prevention of shingles and zoster-related conditions. As a direct and proximate result of her zoster vaccine live (ZOSTAVAX) vaccination, she suffered severe and permanent physical injuries, including but not limited to shingles, as well as other severe and permanent health consequences. On June 2015, the pt was caused to suffer shingles as a result from pt's zoster vaccine live (ZOSTAVAX) use and was treated by a health provider for shingles. The outcome of the event was not reported. The reporter considered the event to be related to zoster vaccine live (ZOSTAVAX).
Age: 68.0
Sex: M
Vaccine: VARZOS
Symptoms: Herpes zoster
Clinical narrative: shingles; This initial spontaneous report was received on from a lawyer regarding a case in litigation and refers to a 67-year-old male patient. The patient's concurrent conditions, medical history and concomitant medication were not provided.   On 03-APR-2013, the patient was vaccinated with a dose zoster vaccine live (ZOSTAVAX) (dosage regimen was not reported) for the long-term prevention of shingles and/or zoster-related conditions.   On or about 15-APR-2013, the patient presented shingles. As a direct and proximate result, the patient had been caused to suffer severe personal injuries, pain, suffering and emotional distress, as well as to incur substantial economic damages. As a direct and proximate result, he suffered severe and permanent physical injuries, including but not limited to shingles, as well as other severe and permanent health consequences; additionally, he had incurred significant expenses for medical care and treatment, his injuries and damages were permanent and would continue into the future.    The reporter considered the event of shingles to be related to zoster vaccine live (ZOSTAVAX).