chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 37.0
Sex: F
Vaccine: COVID19
Symptoms: Myalgia, Pyrexia
Clinical narrative: Chest pain; shortness of breath; elevated heart rate; fever; joint pain; muscle pain; This is a spontaneous report from a contactable consumer (patient). A 37-years-old non pregnant female patient received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Formulation: Solution for injection, Batch/Lot number: not reported, Expiry date: not reported), via an unspecified route of administration in left arm on 13Jul2021 12:00 (at age of 37-years-old) as dose 1, single for covid-19 immunisation. Medical history included allergy to tomatoes, bell peppers, mushrooms, almonds, gluten sensitivity, covid-19. There were no concomitant medications. The patient had not received any other vaccine within 4 weeks. Prior to vaccination, the patient was diagnosed with COVID-19 and post the vaccination, the patient was not tested for COVID-19. On 14Jul2021 11:00, the patient experienced chest pain, shortness of breath, elevated heart rate, fever, joint pain and muscle pain. The patient underwent lab tests and procedures which included heart rate: elevated on an unspecified date. The outcome of the events was unknown.  Information about lot/batch number has been requested.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Sex: M
Vaccine: COVID19
Symptoms: Illness, Rash
Clinical narrative: Sick; big rashes on both of his arms; This is a spontaneous report from a Pfizer-sponsored program COVAX Support. A contactable consumer (Spouse) reported for a male patient (Husband). A male patient with unspecified age received BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: Not reported) dose 2 via an unspecified route of administration on unspecified date in Feb2021 as DOSE 2, SINGLE for COVID-19 immunisation. The patient medical history and concomitant medications were not reported. The patient received first dose of BNT162B2 (PFIZ-ER-BIONTECH COVID-19 VACCINE, Lot number: not reported on unspecified date in Jan2021 for covid-19 immunisation. On unknown date in Mar2021 the patient experienced big ra Reporters on both of his arms and on an unknown date he was sick. Reporter husband received the Pfizer Covid vaccine in January and February, and something is going on with his skin. Reporter doesn't know how to explain it, but he has these big ole' ra Reporters on both of his arms. Reporter mentions her husband has been using hydrocortisone. The patient received treatment for the events with hydrocortisone. The outcome of the events was unknown.  Information on the lot/batch number has been requested.   F/U (PRD/SRD 30Aug2021): Follow-up activities closed: Batch/lot number not available.
Age: 50.0
Sex: F
Vaccine: COVID19
Symptoms: Chills, Decreased appetite, Dizziness, Fatigue, Headache
Clinical narrative: Dizziness, lightheaded; Stabbing headache; chills; nausea; lost of appetite; fever; fatigue; This is a spontaneous report from a contactable consumer (patient herself).  A 50-years-old non-pregnant female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Batch/Lot Number: EW0186), via an unspecified route of administration, administered in left arm (age at vaccination was 50 years old) on 24Jun2021 at 18:00 as DOSE NUMBER UNKNOWN, SINGLE for covid-19 immunisation. Medical history included covid-19 prior to vaccination. The patient's concomitant medications included multivitamin. On 25Jun2021, at 12:00, the patient reported stabbing headache, chills, nausea, loss of appetite, fever, fatigue, diarrhoea, dizziness, lightheaded that is lasting now 18 days. The patient had no known allergies. It was unknown if covid was tested post vaccination. Patient did not receive any treatment. At the time of this report, the outcome of all the events was not recovered.  Follow-up attempts are completed. No further information is expected.
Age: 50.0
Sex: F
Vaccine: COVID19
Symptoms: Nausea, Pyrexia
Clinical narrative: Dizziness, lightheaded; Stabbing headache; chills; nausea; lost of appetite; fever; fatigue; This is a spontaneous report from a contactable consumer (patient herself).  A 50-years-old non-pregnant female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Batch/Lot Number: EW0186), via an unspecified route of administration, administered in left arm (age at vaccination was 50 years old) on 24Jun2021 at 18:00 as DOSE NUMBER UNKNOWN, SINGLE for covid-19 immunisation. Medical history included covid-19 prior to vaccination. The patient's concomitant medications included multivitamin. On 25Jun2021, at 12:00, the patient reported stabbing headache, chills, nausea, loss of appetite, fever, fatigue, diarrhoea, dizziness, lightheaded that is lasting now 18 days. The patient had no known allergies. It was unknown if covid was tested post vaccination. Patient did not receive any treatment. At the time of this report, the outcome of all the events was not recovered.  Follow-up attempts are completed. No further information is expected.
Sex: U
Vaccine: COVID19
Symptoms: Alopecia, Condition aggravated
Clinical narrative: Alopecia; worsening condition; This is a spontaneous report from a contactable consumer (patient) via Pfizer Clinical Trials Contact Center.  A patient of unspecified age and gender received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Batch/Lot number was not reported), dose 1 via an unspecified route of administration on an unspecified date as DOSE 1, SINGLE for covid-19 immunisation. The patient medical history and concomitant medications were not reported. The patient stated she would like to know any new findings on alopecia after Pfizer covid-19 vaccine. She had got one shot 2 months ago and has postponed second dose because of worsening condition. At the time of this report, the outcome of alopecia and condition aggravated was unknown.   No follow-up attempts are possible, no information is expected.
Sex: U
Vaccine: HIBV
Symptoms: Medication error, No adverse event, Product administered to patient of inappropriate age
Clinical narrative: patient who was outside of the labeled age of indication for ActHib, will be receiving ActHib with no reported adverse event; Initial information regarding an unsolicited valid non-serious case was received from pharmacist and non-health care professional (Reference number: 00720491) and transmitted to Sanofi on 11-Aug-2021.  This case involves a patient of unknown age who was outside of the labeled age of indication for HIB (PRP/T) VACCINE [ACT-HIB], will be receiving mentioned vaccine (circumstance or information capable of leading to medication error).  Past medical history, medical treatment(s), vaccination(s), and family history were not provided.  The patient did not receive any concomitant medications and vaccines.  On an unknown date, the patient received an unknown dose of suspect HIB (PRP/T) VACCINE (lot number: unknown and expiration date: unknown) via unknown route in unknown administration site for prophylactic vaccination.  It was case of potential medication error due to circumstance or information capable of leading to medication error (latency: same day).  It was reported, "Pharmacist is asking if ActHIB is only for 2 months through 5 years of age? The pharmacist has a patient who is outside of the labeled age of indication for ActHib. The patient will be receiving ActHib because he/she will be having a splenectomy secondary to trauma".  No adverse events were reported at the time of this report.  At the time of this report, outcome of the event was reported as unknown.  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 the Directive. 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.  There will be no information available regarding batch number in this case.
Age: 4.0
Sex: M
Vaccine: DTAP
Symptoms: Expired product administered, No adverse event
Clinical narrative: the patient was inadvertently administered an expired dose of Daptacel with no reported adverse event; Initial information received on 18-Aug-2021 regarding an unsolicited valid  non-serious case received from a other health professional and consumer/ non healthcare professional via Media information (under reference 00730173).  This case is linked to case 2021SA276926(CLUSTER).  This case involves a 4 years old male patient who was inadvertently administered with an expired dose of DIPHTHERIA, TETANUS AND ACELLULAR PERTUSSIS VACCINE (DAPTACEL) [expired product administered].  Concomitant medication included POLIO VACCINE (lot number and expiration date not reported) via unknown route in an unknown administration site for prophylactic vaccination.  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.   On 03-Aug-2021, the patient received 0.5mL fifth dose of suspect DIPHTHERIA, TETANUS AND ACELLULAR PERTUSSIS VACCINE (DAPTACEL) [total, lot C5643BA and expiration date: 17-Jul-2021] via intramuscular route in the left deltoid for prophylactic vaccination.  It was an actual medication error due to expired vaccine used (same day latency).  At time of reporting, no adverse event was reported and the outcome was unknown for the reported event.    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. 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: 5.0
Sex: F
Vaccine: DTAP
Symptoms: Expired product administered
Clinical narrative: the patient was inadvertently administered dose of Daptacel that had expired on 17 July 2021/no AE; Initial information regarding an unsolicited valid non-serious case was received from the other Healthcare Professional (HCP) via medical information (Reference number- 00730261).  This case involves a five-year-old female patient who received an expired DIPHTHERIA-15/TETANUS/5 AC PERTUSSIS VACCINE [DAPTACEL] (expired product administered).  The patient's medical history, past medical treatment(s), vaccination(s) and family history were not provided.  Concomitant medications included POLIO VACCINE for prophylactic vaccination.  On 13-Aug-2021, the patient received a fifth dose 0.5 mL of suspect DIPHTHERIA-15/TETANUS/5 AC PERTUSSIS VACCINE (lot C5643BA, expiry date-17-Jul-2021) via an intramuscular route in the left deltoid for prophylactic vaccination (expired product administered).  It was a case of actual medication error due to expired vaccine used (same day).  It was reported, "HCP called to ask for information on managing 3 patients who had inadvertently been administered an expired dose of Daptacel. Two of the patients were administered the expired dose on 03 Aug 2021, and the other patient was administered the expired dose on 13 Aug 2021".  At the time of reporting, no adverse event was reported.  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. 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: 29.0
Sex: F
Vaccine: YF
Symptoms: Headache, Incorrect route of product administration, Medication error, Pain
Clinical narrative: body ache that are worse at night; headache and body ache that are worse at night; patient received YF-VAX intramuscularly instead of subcutaneously; Initial information was received on 20-Aug-2021 regarding an unsolicited valid non-serious case received from a consumer (patient).  This case involves a 29 year-old female patient who experienced body ache and headache that are worse at night (pain), (headache), after receiving vaccine YELLOW FEVER VACCINE [YF-VAX] (Incorrect route of product administration).  The patient's medical history, medical treatment(s), vaccination(s) and family history were not provided.  No concomitant therapy was given.  Reporter stated she was not pregnant   On 18-Aug-2021, the patient received (once) dose of suspect YELLOW FEVER VACCINE (Solution; lot UJ386AA and expiry date not reported) via an intramuscular route in the right deltoid for prophylactic vaccination.  On 18-Aug-2021, the patient developed non-serious body ache and headache that are worse at night (pain), (headache) on the same day following the administration of YELLOW FEVER VACCINE.  It was also a case of actual medication error due to in appropriate route of vaccination (latency was on same day).  It was reported "Caller states she received YF-VAX intramuscularly instead of subcutaneously. Caller asking for safety and efficacy information regarding YF-VAX given intramuscularly. Caller also asking for clinical studies of YF-VAX given intramuscularly vs. subcutaneously. States she received YF-VAX because she will be traveling soon.  Details of laboratory data were not reported.  Caller reported she had not taken anything or gone to doctor for headache and body aches.  At time of reporting, outcome of the events was unknown.  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 the 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.
Sex: U
Vaccine: MNQ
Symptoms: Expired product administered, No adverse event
Clinical narrative: patient received expired vaccine MENACTRA with no reported adverse event; Initial information was received on 23-Aug-2021 regarding an unsolicited valid non-serious case from a consumer or non-healthcare professional (Reference number- 00735391).  This case involves a patient of (unknown demographics) who was administered expired vaccine MENINGOCOCCAL A-C-Y-W135 VACCINE [MENACTRA] (expired product administered).  The patient's medical history, past medical treatment, vaccination, and family history were not provided.  On an unknown date, the patient received a dose of suspect MENINGOCOCCAL A-C-Y-W135 (D CONJ) VACCINE (lot number and expiry date not reported) via an unknown route at an unknown administration site for prophylactic vaccination.  It was an actual medication error due to expired vaccine used (latency: same day).  At the time of reporting, no adverse event reported.  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 the Directive. 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.  There will be no information available on the batch number for this case.
Age: 17.0
Sex: F
Vaccine: TDAP
Symptoms: Syringe issue, Underdose
Clinical narrative: when administering ADACEL to a patient a few drops leaked under and around the luer lock, therefore patient did not received entire 0.5mL dose, no AE; Few drops leaked out under the luer lock with no adverse event; Initial information received on 23-Aug-2021 regarding an unsolicited valid non-serious case from consumer/non-health care professional (under the reference 00735729).  This case involved a 17 years old female patient who did not received the entire 0.5 ml dose of DIPHTHERIA-2/TETANUS/5 AC PERTUSSIS VACCINE [ADACEL] due to the drops leaked out under the luer lock (underdose, syringe issue).  The patient's past medical history, medical treatment(s), vaccination(s), and family history were not provided.  Concomitant medications included MENINGOCOCCAL VACCINE A/C/Y/W CONJ (DIP TOX) (MENACTRA) (lot number and expiration date not reported) via unknown route in an unknown administration site for prophylactic vaccination on an unknown date.  On 23-Aug-2021, the patient received a second dose of suspect DIPHTHERIA-2/TETANUS/5 AC PERTUSSIS VACCINE (suspension for injection, 0.5 ml once, lot U6984AA and expiration date: 18-Mar-2023) via intramuscular route in the left arm for prophylactic vaccination.  It was an actual medication error due to vaccine underdose (same day latency) and also a case of syringe leak (same day latency).  It was reported Call received from HCP reporting when administering ADACEL to a patient a few drops leaked under and around the luer lock, therefore patient did not received entire 0.5mL dose. Caller with question on whether dose needs repeating. Direct, Indirect from a distributor, neglected to ask; Number of units affected: 1. Is dose not used or not available: used. Whether product is available for return; Leaking (gather as much info as possible); Where is it leaking from? (use vial & syringe guides). Under the luer lock o When did the leakage occur? when administering; Quantity of the leak (e.g. only a few droplets or half the dose) a few drops; Diluent or vaccine leaking? vaccine; During withdrawal from vial? NA  (not applicable); Sanofi Pasteur prefilled syringe or your syringe? prefilled syringe; Was air injected into vial? NA; Was there a vacuum in the vial? NA; Was vial punctured multiple times? NA; Did the product spray out of the vial? NA; Any signs of damage or tampering with the vial, stopper, flip seal or carton? No; How often was vial punctured? NA.  At time of reporting, it was unknown whether the patient had any adverse event or not  and the outcome was unknown for the reported event.  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 the Directive. 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.
Sex: U
Vaccine: DTAP
Symptoms: Expired product administered, No adverse event
Clinical narrative: expired DAPTACEL had been administered to a patient with no reported adverse event; Initial information regarding an unsolicited valid non-serious case was received from other health care professional and consumer/non-health care professional via Medical Information (Reference number- 00739683).  This case involved an unknown (age and gender) patient who administered expired DIPHTHERIA-15/TETANUS/5 AC PERTUSSIS VACCINE [DAPTACEL] (expired product administered)  Relevant medical history, medical treatment(s), vaccination(s) concomitant medication and family history were not provided.   On an unknown date, the patient received a dose of suspect DIPHTHERIA-15/TETANUS/5 AC PERTUSSIS VACCINE (lot number was not reported and expiry date: 23-May-2021) via unknown route in unknown administration site for prophylactic vaccination (expired product administered).  It was reported,"Caller reports that they had 6 vials of DAPTACEL that expired 23MAY2021. Caller asking if this is okay or if they should re-administer. Called declined to provided information for AE (adverse event)/safety report at time of call. Caller states she would like to speak to her office manager and the provider first. Caller given case reference number and phone number to reach for Information. Caller states she will call back if she is able to provide information for AE/safety report."  This case was an actual medication error due to expired vaccine used (latency: same day)  At the time of reporting, no adverse event  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. 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.  There will be no information available on the batch number for this case.
Sex: F
Vaccine: HIBV
Symptoms: Expired product administered
Clinical narrative: Received expired ACTHIB vaccinations with no reported adverse event; Initial information received on 25-Aug-2021 regarding an unsolicited valid  non-serious case received from a other health professional.  This case is linked to case 2021SA284000 (CLUSTER).  This case involves a 1 years old female patient who received expired dose of HIB (PRP/T) VACCINE [ACT-HIB].  Medical history, medical treatment(s), vaccination(s), and family history were not provided.  Concomitant medications included PNEUMOCOCCAL VACCINE 13V (PNEUMOCOCCAL 13 VALENT VACCINE) for Prophylactic vaccination; and DIPHTHERIA VACCINE TOXOID, PERTUSSIS VACCINE ACELLULAR, TETANUS VACCINE TOXOID (DTAP) for Prophylactic vaccination.  On 24-Aug-2021, the patient received a 0.5 mL fourth dose of suspect HIB (PRP/T) VACCINE lot UJ351AA, expiry date- 09-Aug-2021 via intramuscular route in the left thigh for prophylactic vaccination.  It was a case of an actual medication error due to expired vaccine used (latency same day).  It was reported, "If baby was delivered: delivery date and if baby experienced an adverse event ? Inform that they will be receiving a follow up questionnaire ? If calling specifically about being added to the pregnancy registry: all pregnancy cases are added to the registry, it is an FDA requirement.  At time of reporting, no adverse event was reported.   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 the Directive. 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: 54.0
Sex: F
Vaccine: YF
Symptoms: Incorrect route of product administration
Clinical narrative: vaccine was accidently administered intramuscularly instead of subcutaneously/ no AE; Initial information regarding an unsolicited valid non-serious case was received on 25-Aug-2021 from an Other health care professional via Medical Information (MI) (Reference number- 00740843) and transmitted to Sanofi on 26-Aug-2021.  This case involves a 54-year-old female patient who accidently administered the YELLOW FEVER VACCINE [YF-VAX] intramuscularly instead of subcutaneously with no reported adverse event (incorrect route of product administration).  The patient's past medical history included Typhoid. The patient's past medical treatment(s), vaccination(s), concomitant medications and family history were not provided. At the time of the event, the patient had ongoing Hepatitis A.   On 25-Aug-2021, the patient received 0.5 ml (total) dose (once) of suspect YELLOW FEVER VACCINE [lot UJ371AB and expiry date 21-Jul-2022] via intramuscular route in left deltoid for prophylactic vaccination.  It was reported, "She accidently administered the vaccine intramuscularly instead of subcutaneously".  It was a case of actual medication error due to inappropriate route of vaccination (latency was on the same day).  At the time of reporting, patient had no adverse event.  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: 24.0
Sex: F
Vaccine: COVID19
Symptoms: Feeling hot, Rash, Rash erythematous, Rash pruritic, Urticaria
Clinical narrative: Roughly an hour or two after having the vaccine, I began to feel very hot and itchy. I noticed red patches all over my body that where slowly spreading all over. I contacted the pharmacy who administered the vaccine and they indicated that I should take over the counter allergy medication and follow up with my primary care provider. I took Benadryl every 4 hours to stop the hives and rash from itching. I followed up with my pcp on Monday 8/30. She directed me to report the case,  and go to urgent care. I went to urgent care after work on Monday . The doctor there advised I was more than likely reacting negatively to the vaccine. Not to receive a second dose, she examined the hives and rash, gave me a steroid to take 2 times daily for the following 5 days.
Age: 51.0
Sex: F
Vaccine: COVID19
Symptoms: Tachycardia
Clinical narrative: tachycardia for one week. Resting HR was 120-135, HR increased with activity. highest HR 170.
Age: 31.0
Sex: M
Vaccine: COVID19
Symptoms: Lymphadenopathy, Oedema
Clinical narrative: Received IM injection in left shoulder. Developed diffuse edema in my armpit two days later without palpable lymphadenopathy. Worsening over the last 48 hours.
Age: 49.0
Sex: F
Vaccine: COVID19
Symptoms: Cellulitis, Infection
Clinical narrative: Error: Infection / Cellulitis (diagnosed by MD)-
Age: 77.0
Sex: M
Vaccine: COVID19
Symptoms: Product storage error
Clinical narrative: Error: Improper Storage (temperature)-
Sex: U
Vaccine: HEPA, MMR, RV5
Symptoms: No adverse event, Product storage error
Clinical narrative: improperly stored administered MMR II, VAQTA and ROTATEQ; No additional AE reported; This spontaneous report was received from a nurse referring to unknown number of patient with unknown age and gender. No information regarding the patient's concurrent conditions, medical history, drug reactions or allergies and concomitant medications was provided. Concomitant medication included sterile diluent(STERILE DILUENT) (lot# reported as T018895).   On unknown dates, the patients were vaccinated with improperly stored dose of measles, mumps, and rubella (wistar ra 27-3) virus vaccine, live(rHA)(M-M-R II) (lot # T001214, expiration date 12-JAN-2022, 1 dose, dose number and route of administration were not reported), or hepatitis a vaccine, inactivated(VAQTA) (lot#T023914, expiration date 31-MAR-2022,1 dose, dose number and route of administration were not reported), or rotavirus vaccine, live, oral, pentavalent(ROTATEQ) (lot# reported as 1741416, expiration date 21-MAR-2022, 1 dose, dose number and route of administration were not reported) for prophylaxis.   The vaccines were stored improperly in the temperature of 9 degree Celsius for the time frame of 12 minutes. There was no previous temperature excursion. Digital Data Logger was involved. No adverse event was reported. combinationproductreport: Yes; brandname: VAQTA SYRINGE (DEVICE); commondevicename: Hepatitis A Vaccine, Inactivated; productcode: FMF; manufacturername: Merck Sharp & Dohme Corp.; devicelotnumber: T023914; expirationdate: 31-MAR-2022; deviceage and unit: 0 ; malfunction: Unknown; deviceusage: Initial; reasonfornoneval: 81 Other; labeledsingleusedevice: No; mdcpreportability: No; mdcpreprationale: Case information does not meet criteria for reportability
Sex: U
Vaccine: MMRV, VARCEL
Symptoms: Inappropriate schedule of product administration, No adverse event
Clinical narrative: No additional AE reported; one year old patient administered PROQUAD and VARIVAX on the same day; This spontaneous report was received from an administrator referring to a 1 year old patient of unknown gender. No information regarding the patient's concurrent conditions, medical history, drug reactions or allergies and concomitant medications was provided.    On 03-AUG-2021, the patient was vaccinated with a  dose of measles, mumps, rubella and varicella (oka-merck) virus vaccine live(PROQUAD), (lot#, expiration date and route were not provided, 0.5 milliliter) and a dose of varicella virus vaccine live (oka/merck)(VARIVAX) (lot#, expiration date and route were not provided, 0.5 milliliter) for prophylaxis (inappropriate schedule of product administration). No adverse event was reported.
Age: 55.0
Sex: M
Vaccine: PNC13
Symptoms: Extra dose administered, Inappropriate schedule of product administration
Clinical narrative: no other AE; misuse/Administration of vaccine outside of recommended dosing schedule; This spontaneous report was received from a pharmacy intern, referring to a 55-year-old male patient with human immunodeficiency virus (HIV). Information regarding the patient's pertinent medical history, drug reactions/allergies and concomitant medication was not provided.     On an unknown date in 2013, the patient was vaccinated with pneumococcal vaccine, polyvalent (23-valent)(PNEUMOVAX23) (dose, strength, route, lot# and expiration date were not provided) for prophylaxis and then was vaccinated with pneumococcal vaccine, polyvalent (23-valent)(PNEUMOVAX23) (dose, strength, route, lot# and expiration date were not provided) for prophylaxis again on an unknown date in 2014. On an unknown date in 2017, the patient was vaccinated with pneumococcal vaccine conj 13v (crm197) (PREVNAR 13) (inappropriate schedule of product administration). No further information.
Age: 64.0
Sex: U
Vaccine: VARZOS
Symptoms: Herpes zoster
Clinical narrative: shingles; other zoster related injuries; Information has been received from a lawyer and a currently 70-year-old patient of unknown gender regarding a case in litigation. Information about concurrent condition, medical history and concomitant medication was not reported. On or about 01-OCT-2015, the patient was vaccinated with zoster vaccine live (ZOSTAVAX) (strength, dose, lot# and route unknown) for the long-term prevention of shingles and zoster-related conditions. Subsequently (date not reported), the patient was treated by a physician for the following injuries resulting from zoster vaccine live (ZOSTAVAX) use: shingles and other zoster related injuries. The outcome of all events was unknown. The causality between all events and zoster vaccine live (ZOSTAVAX) was related.
Age: 63.0
Sex: U
Vaccine: VARZOS
Symptoms: Herpes zoster
Clinical narrative: shingles; other zoster related injuries; Information has been received from a lawyer and a currently 69-year-old patient of unknown gender regarding a case in litigation. Information about concurrent condition, medical history and concomitant medication was not reported. On or about 01-MAY-2015, the patient was vaccinated with zoster vaccine live (ZOSTAVAX) (strength, dose, lot# and route unknown) for the long-term prevention of shingles and zoster-related conditions. Subsequently (date not reported), the patient was treated by healthcare providers for the following injuries resulting from zoster vaccine live (ZOSTAVAX) use: shingles and other zoster related injuries. The outcome of all events was unknown. The causality between all events and zoster vaccine live (ZOSTAVAX) was related
Sex: F
Vaccine: HEP
Symptoms: Mobility decreased
Clinical narrative: She could not move her arm or joints; She could not move her arm or joints; This spontaneous report was received from a case in litigation for zoster vaccine live (ZOSTAVAX) (MARRS # 2107USA004314) and concerns female patient of unknown age. There was no information about the patient's concurrent conditions, concomitant therapies or medical history provided.  On an unknown date in 2005, the patient was vaccinated with hepatitis B vaccine (manufacturer unknown) (exact dose, route of administration, anatomical location, lot # and expiration date were not reported) for prophylaxis.  On an unknown date, after the vaccination, the patient could not move her arm or joints.  The outcome of the events was not reported. The reporter considered the events to be related to hepatitis B vaccine (manufacturer unknown).  This is one of two reports regarding the same patient. Sender's Comments: US-009507513-2107USA004314.
Sex: U
Vaccine: MMRV
Symptoms: No adverse event, Product storage error
Clinical narrative: No additional AE reported; PROQUAD was administered on 08/25/2021 following a temperature excursion; This spontaneous report has been received from an office manager referring to an unknown age and gender patient. The patient's concomitant medications, pertinent medical history, drug reactions or allergies were not reported.  On 25-AUG-2021, the patient was vaccinated with the improperly stored measles, mumps, rubella and varicella (oka-merck) virus vaccine live (albumin status recombinant Human albumin (rHA)) (PROQUAD) (dose, strength, route of administration and anatomical location were not provided; lot # U009260, expiration date reported as 19-SEP-2022) for prophylaxis (product storage error). The vaccine underwent temperature excursion of -10.7 degree Celsius for total 192 hours. It was reported that there were no previous temperature excursions. At the time of report, there was no additional adverse event (AE).
Sex: U
Vaccine: VARZOS
Symptoms: Herpes zoster
Clinical narrative: other zoster-related conditions; shingles; This spontaneous report has been received from a lawyer regarding a case in litigation and refers to a currently 77-year-old patient of unknown gender. The patient's concurrent conditions, medical history and concomitant medications were not reported. In or about 2017, the patient was administered zoster vaccine live (ZOSTAVAX) (dose, route of administration, anatomical location, lot # and expiry date were not provided) by a pharmacist at a pharmacy for the long-term prevention of shingles and zoster-related conditions. Subsequently, on an unknown date, the patient was treated by the physician for the following injuries resulting from the patient's zoster vaccine live (ZOSTAVAX) use: shingles and other zoster-related conditions. The outcome of the events was not provided. The reporter considered the events to be related to zoster vaccine live (ZOSTAVAX).
Sex: U
Vaccine: VARZOS
Symptoms: Malaise
Clinical narrative: Sick; Dont feel well; This case was reported by a consumer and described the occurrence of sickness in a patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   On 21st August 2021, the patient received the 1st dose of Shingles vaccine. On 22nd August 2021, 1 days after receiving Shingles vaccine, the patient experienced sickness and feeling unwell. On an unknown date, the outcome of the sickness and feeling unwell were not recovered/not resolved.  It was unknown if the reporter considered the sickness and feeling unwell to be related to Shingles vaccine.  Additional details were reported as follows: This case was reported by the patient for herself/himself. The age at vaccination was not reported. The patient stated that got the shingles vaccine on Saturday, got sick from it yesterday and still don't feel well. The follow-up would not possible as no contact details were available.
Sex: U
Vaccine: VARZOS
Symptoms: Burning sensation, Herpes zoster, Pain
Clinical narrative: Shingles; Hurt; Burning under my skin; This case was reported by a consumer and described the occurrence of shingles in a patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   On an unknown date, the patient received Shingles vaccine. On an unknown date, 2 weeks after receiving Shingles vaccine, the patient experienced shingles, pain and burning sensation. On an unknown date, the outcome of the shingles, pain and burning sensation were not recovered/not resolved.  It was unknown if the reporter considered the shingles, pain and burning sensation to be related to Shingles vaccine.  Additional details were reported as follows: This case was reported by the patient for herself/himself. The age at vaccination was not reported. The patient reported that got shingles Vaccine and two weeks later, got the shingles it hurt like hell, still burning under the skin. The follow-up would not possible as no contact details were available.
Sex: F
Vaccine: VARZOS
Symptoms: Discomfort, Herpes zoster, Pain
Clinical narrative: shingles; discomfort; pain; This case was reported by a consumer and described the occurrence of shingles in a female patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   Previously administered products included Shingles vaccine (received 1st dose on an unknown date).   On an unknown date, the patient received the 2nd dose of Shingles vaccine. On an unknown date, 1 week after receiving Shingles vaccine, the patient experienced shingles, discomfort and pain. On an unknown date, the outcome of the shingles, discomfort and pain were not recovered/not resolved.   It was unknown if the reporter considered the shingles, discomfort and pain to be related to Shingles vaccine.  Additional details were provided as follows: The patient was reporter's friend. The age at vaccination was not reported.  The patient had both shots and a week again came down with shingles on her neck, shoulder and down her arm. The patient was in a lot of discomfort and pain.
Sex: U
Vaccine: VARZOS
Symptoms: Eye disorder, Herpes zoster, Vaccination failure
Clinical narrative: I got the shingles shot then I got shingles; shingles; flu,; issues with my left eye; This case was reported by a consumer via interactive digital media and described the occurrence of suspected vaccination failure in a 68-year-old patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   On an unknown date, the patient received Shingles vaccine. On an unknown date, unknown after receiving Shingles vaccine, the patient experienced vaccination failure (serious criteria GSK medically significant), shingles, influenza and eye disorder. On an unknown date, the outcome of the vaccination failure, shingles and influenza were unknown and the outcome of the eye disorder was not recovered/not resolved.   It was unknown if the reporter considered the vaccination failure, shingles, influenza and eye disorder to be related to Shingles vaccine.  Additional details were provided as follows: The case reported by patient. The age at vaccination was not reported. The patient got the shingles shot then the next fall the patient got first flu shot. The next week the patient experienced the flu, a light case of shingles and still have issues with left eye. This case was considered as suspected vaccination failure since the details regarding completion of primary vaccination schedule, time to onset and laboratory confirmation of shingles were not provided. For tolerance to Flu vaccine refer case US2021AMR181695.; Sender's Comments:  US-GLAXOSMITHKLINE-US2021AMR181695:same patient same reporter
Sex: U
Vaccine: VARZOS, VARZOS
Symptoms: Ear disorder, Feeling abnormal, Herpes zoster, Herpes zoster oticus, Nerve injury
Clinical narrative: shingles in and around my right ear; Suspected Vaccination failure; shingles; pain was excruciating.; I still have trouble with my ear; nerve had been fried; felt like I had been electrocuted; This case was reported by a consumer via media and described the occurrence of suspected vaccination failure in a 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. In May 2020, 5 months after receiving Shingles vaccine and unknown after receiving Shingles vaccine, the patient experienced vaccination failure (serious criteria GSK medically significant), shingles, pain, ear disorder, nerve damage and feeling abnormal. On an unknown date, the patient experienced herpes zoster otitis externa (serious criteria GSK medically significant). On an unknown date, the outcome of the vaccination failure, shingles, pain, nerve damage, feeling abnormal and herpes zoster otitis externa were unknown and the outcome of the ear disorder was not recovered/not resolved.   It was unknown if the reporter considered the vaccination failure, shingles, pain, ear disorder, nerve damage, feeling abnormal and herpes zoster otitis externa to be related to Shingles vaccine and Shingles vaccine.  Additional details were provided as follows: The case was reported by patient. The age at vaccination was not reported. The received both shingle shots. Five months later, the patient experienced the shingles that wrapped around shin, up the right side of my head, in and around right ear and up the back of neck and head. The pain was excruciating.  The patient felt like he/she had been electrocuted. The physician said nerve had been fried. The patient stated that it was in May 2020. It lasted into the fall.  The patient stated that it was August 2021 and the patient still had trouble with ear.  This case was considered as suspected vaccination failure since the details regarding laboratory confirmation of shingles were not provided.
Sex: U
Vaccine: VARZOS, VARZOS
Symptoms: Pain, Vaccination failure
Clinical narrative: shingles in and around my right ear; Suspected Vaccination failure; shingles; pain was excruciating.; I still have trouble with my ear; nerve had been fried; felt like I had been electrocuted; This case was reported by a consumer via media and described the occurrence of suspected vaccination failure in a 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. In May 2020, 5 months after receiving Shingles vaccine and unknown after receiving Shingles vaccine, the patient experienced vaccination failure (serious criteria GSK medically significant), shingles, pain, ear disorder, nerve damage and feeling abnormal. On an unknown date, the patient experienced herpes zoster otitis externa (serious criteria GSK medically significant). On an unknown date, the outcome of the vaccination failure, shingles, pain, nerve damage, feeling abnormal and herpes zoster otitis externa were unknown and the outcome of the ear disorder was not recovered/not resolved.   It was unknown if the reporter considered the vaccination failure, shingles, pain, ear disorder, nerve damage, feeling abnormal and herpes zoster otitis externa to be related to Shingles vaccine and Shingles vaccine.  Additional details were provided as follows: The case was reported by patient. The age at vaccination was not reported. The received both shingle shots. Five months later, the patient experienced the shingles that wrapped around shin, up the right side of my head, in and around right ear and up the back of neck and head. The pain was excruciating.  The patient felt like he/she had been electrocuted. The physician said nerve had been fried. The patient stated that it was in May 2020. It lasted into the fall.  The patient stated that it was August 2021 and the patient still had trouble with ear.  This case was considered as suspected vaccination failure since the details regarding laboratory confirmation of shingles were not provided.
Sex: U
Vaccine: VARZOS, VARZOS
Symptoms: Ophthalmic herpes zoster, Vaccination failure
Clinical narrative: had the vaccine twice but still got them/ suspected vaccination failure; got them in my eye; This case was reported by a consumer via media and described the occurrence of suspected vaccination failure in a 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 ophthalmic herpes zoster (serious criteria GSK medically significant). On an unknown date, the outcome of the vaccination failure and ophthalmic herpes zoster were unknown.   It was unknown if the reporter considered the vaccination failure and ophthalmic herpes zoster to be related to Shingles vaccine and Shingles vaccine.  Additional details were provided are as follows: The case was reported by patient himself/ herself. The age at vaccination was not reported. The patient had the Shingles vaccine twice but still got them in his/her eye. This case was considered as suspected vaccination failure since the details regarding time to onset and laboratory test confirming shingles were unknown at the time of reporting. The follow up would not be possible as no contact details were available.
Sex: U
Vaccine: VARZOS
Symptoms: Herpes zoster, Vaccination failure
Clinical narrative: Had it 2 years ago and shingles still on/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.   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 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.  Additional details were reproted as follows: The case was reported by the patient. The age at vaccination was not reported. The patient had the Shingles vaccine 2 years prior to the report and still had shingles that goes off and on. This case was considered as suspected vaccination failure as details regarding completion of primary vaccination schedule, time to onset and laboratory confirmation of shingles were unknown at the time of reporting.
Sex: U
Vaccine: VARZOS
Symptoms: Herpes zoster, Vaccination failure
Clinical narrative: I know that took it got it/suspected vaccination failure; got it; This case was reported by a consumer via interactive digital media and described the occurrence of  suspected vaccination failure in a patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   On an unknown date, the patient received Shingles vaccine. On an unknown date, unknown after receiving Shingles vaccine, the patient experienced vaccination failure (serious criteria GSK medically significant) and shingles. On an unknown date, the outcome of the vaccination failure and shingles were unknown.   It was unknown if the reporter considered the vaccination failure and shingles to be related to Shingles vaccine.  Additional details were reported as follows: The case was reported by the patient. The age at vaccination was not reported. The patient took the Shingles vaccine and got the shingles, so the patient said that do not take the shot everyone, as the patient knew that. This case was considered as suspected vaccination failure as details regarding completion of primary vaccination schedule, time to onset and laboratory confirmation of shingles were unknown at the time of reporting.