chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Sex: F
Vaccine: COVID19
Symptoms: Herpes ophthalmic
Clinical narrative: herpes on her eye 8 hours; This is a spontaneous report from a contactable consumer (Patient) via Medical Information Team. A 31-year-old female patient received first dose of BNT162B2 (PFIZER- BIONTECH COVID- 19 VACCINE, Solution for injection, lot number was not reported), via an unspecified route of administration on 08Jun2021 as single dose for COVID-19 immunisation. The patient medical history and concomitant medications were not reported. It was reported that, the patient experienced herpes on her eye 8 hours after getting the first dose of the vaccine. Patient stated that she had no medical information question and was calling in just to report the adverse event. The outcome of the event was unknown.  Information about lot/batch number has been requested.
Age: 68.0
Sex: U
Vaccine: COVID19
Symptoms: COVID-19, Drug ineffective, SARS-CoV-2 test
Clinical narrative: got the virus before I receive the second dose; got the virus before I receive the second dose; This is a spontaneous report from a contactable consumer. A 68-years-old patient of unspecified gender received bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Solution for injection, Batch/Lot Number: EN6208), dose 2 via an unspecified route of administration on 19Mar2021 (at 68-years age) as 2ND DOSE, SINGLE DOSE for covid-19 immunizations. Patient medical history was not reported. Family history includes death of mother and father, mother had breast cancer and father had liver cancer. The patient's concomitant medications were not reported. Patient previously received bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Solution for injection, Batch/Lot Number: EM9809), dose 1 via an unspecified route of administration on 05Feb2021 at 14:00 PM as 1st dose, single dose for covid-19 immunizations. The patient got the virus before patient receive the second dose. After the Quarantine patient received the Second Dose. Patient was ok now (unspecified). No treatment received for reported adverse event. The outcome of the events was unknown.
Age: 29.0
Sex: M
Vaccine: COVID19
Symptoms: Axillary pain, Inappropriate schedule of product administration, Swelling
Clinical narrative: My left armpit swelled up to a baseball cut in half size. Very painful to the touch at times.; My left armpit swelled up to a baseball; Second dose on 07Jun2021, first dose received on 24May2021; This is a spontaneous report from a contactable consumer (patient). A 29-year-old-male patient received second dose of bnt162b2 (BNT162B2), via an unspecified route of administration, administered in Arm Right on 07Jun2021 14:00 (Inappropriate schedule) (Lot Number: Ew0179) as single dose (at age of 29-year-old) for covid-19 immunisation. Medical history was not reported. Concomitant medications included paracetamol (TYLENOL); celecoxib (CELEBREX). The patient previously took gabapentin and experienced hypersensitivity, pregabalin (LYRICA) and experienced hypersensitivity. First dose of bnt162b2 (BNT162B2) was administered on 24May2021 at 13:00 (at age of 29-year-old) in Left arm for covid-19 immunisation, lot number: Ew0179. The patient did not receive any other vaccines within four weeks prior to the vaccination. Patient did not have COVID prior vaccination and also patient was not tested for COVID since the vaccination.  Patient stated that on 08Jun2021 08:00 his left armpit swelled up to a baseball cut in half size. Very painful to the touch at times. No treatment was received. Events resulted in Emergency room/department or urgent care. Patient had not recovered from the events.
Sex: M
Vaccine: COVID19
Symptoms: Myocardial infarction
Clinical narrative: Heart attack; This is a spontaneous report from a non-contactable other HCP via Medical Information Team. A 58-year-old male patient received received BNT162B2 (PFIZER BIONTECH COVID-19 mRNA VACCINE, Solution for injection, Batch/Lot number: not reported), via an unspecified route of administration on unspecified date as an Unknown, Single Dose for Covid-19 immunization. The patient's medical history and concomitant medications were not reported. The reporter stated that another person had a heart attack on the freeway with less than a month of getting the Pfizer vaccine. The reporter stated this patient was a 58-year-old male. The reporter stated, he would never get another one, he hopes to God his son never gets one either, he was telling everyone they should take Loroquine (reporter does not had spelling), not even sure if available. The outcome of the event was unknown.; Sender's Comments: As there is limited information in the case provided, the causal association between the event and the suspect drug cannot be excluded. The case will be reassessed once new information is available.  The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to regulatory authorities, Ethics Committees, and Investigators, as appropriate.
Sex: U
Vaccine: IPV
Symptoms: Expired product administered
Clinical narrative: patient was given expired IPOL/ NO AE; Initial information received on 28-May-2021 regarding an unsolicited valid non-serious case received from a other health professional.  This case involves pediatric patient who received expired IPV (VERO) [IPOL] (batch number not reported and expiry date: 13-Mar-2021) on 28-May-2021 (expired product administered) for prophylactic vaccination by nurse.  The patient's past medical treatment, vaccination, concomitant medication and family history were not provided.  It is unknown if the patient had any medical history, concomitant disease or risk factor.  It was an potential medication error case due to expired vaccine used (latency: same day).  It was unknown if there were lab data/results available.   It is unknown if the patient experienced any additional symptoms/events.  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.  There will be no information available on the batch number for this case.
Age: 0.5
Sex: M
Vaccine: DTAPIPVHIB
Symptoms: Expired product administered, No adverse event
Clinical narrative: patient received an expired dose of Pentacel with no adverse event reported; Initial information received on 03-Jun-2021 regarding an unsolicited valid non-serious case received from a other health professional via Medical Information (Reference number- 00627057).  This case involves a 6 month-old male patient who was vaccinated with 0.5 mL (once, standard) expired dose of DIPHTHERIA/TETANUS/5 HYBRID AC PERTUSSIS/IPV(VERO)/HIB(PRP/T) VACCINE [PENTACEL (VERO)] (batch number UJ227AA-for HIB component and expiry date 23-Apr-21) via an intramuscular route at the left thigh on 28-May-21 for prophylactic vaccination (expired product administered).  The patient's medical history, medical treatment(s), vaccination(s) and family history were not provided.  Concomitant medications included PNEUMOCOCCAL VACCINE CONJ 7V (CRM197) (PREVNAR) for prophylactic vaccination.  It was a case of an actual medication error due to expired vaccine used (latency was on same day).  At the time of report, no adverse event reported.  Result of assessment was not 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 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.  There will be no information available on batch number for this case.
Age: 0.33
Sex: M
Vaccine: HIBV
Symptoms: No adverse event, Product preparation issue
Clinical narrative: ACTHIB was reconstituted with sterile water diluent instead of 0.4% saline with no reported adverse event; Initial information regarding an unsolicited valid non-serious case was received from a other health care professional via physician via the Medical Information (Reference number- 00628765) and transmitted to Sanofi on 04-Jun-2021.  This case involves a 4 months old male patient who received 0.5 ml second dose of HIB (PRP/T) VACCINE [ACT-HIB] reconstituted with sterile water diluent instead of 0.4% saline (lot UJ426AAB, expiry: 03-Jul-2022, Injection) via intramuscular route in the right thigh for prophylactic vaccination on 24-May-2021 (Product preparation error)  Medical history, medical treatment(s), vaccination(s) and family history were not provided.  Concomitant medications included PNEUMOCOCCAL VACCINE CONJ 13V (CRM197) (PREVNAR 13), ROTAVIRUS VACCINE (ROTAVIRUS VACCINE) and DIPHTHERIA VACCINE TOXOID, HEPATITIS B VACCINE RHBSAG (YEAST), PERTUSSIS VACCINE ACELLULAR 3-COMPONENT, POLIO VACCINE INACT 3V (VERO), TETANUS VACCINE TOXOID (PEDIARIX) for prophylactic vaccination.  It was a case of an actual medication error due to Wrong diluent used (latency same day)  At the time of report, no adverse event was reported  The caller reported that he was reviewing their vaccine log and noted that on 24-May-2021, a male child was administered a dose of ACT-HIB incorrectly. The caller wanted to know what to do now. The vaccine will be repeated.  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.
Age: 51.0
Sex: F
Vaccine: TYP
Symptoms: Expired product administered, No adverse event
Clinical narrative: Patient was administered with an expired 0.5ml dose of Typhim VI with no AE; Initial information regarding an unsolicited valid non-serious case was received from a other health care professional via Medical Information (Reference number- 00631153) and transmitted to Sanofi on 07-Jun-2021.  This case involves a 51 years old female patient who received a 0.5 mL expired dose of suspect TYPHOID VI POLYSACCHARIDE VACCINE [TYPHIM VI] (batch number: R1B741M and expiry date : 23-Mar-2021) via unknown route in left deltoid (expired product administered) for prophylactic vaccination on 11-May-2021.  The patient's medical history, past medical treatment, vaccination, concomitant medication and family history were not provided.  It was an actual medication error case due to expired vaccine used (latency: same day).  The patient received no other medications or vaccinations on that visit.   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 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.
Age: 41.0
Sex: F
Vaccine: COVID19
Symptoms: Chills, Fatigue, Headache, Restlessness
Clinical narrative: Headache for the past 11 hours; severe chills for at least 5 hours (went to sleep and chills were gone); feeling dehydrated since I got the shot; fatigue and restlessness
Age: 23.0
Sex: M
Vaccine: COVID19
Symptoms: Chest pain, Pericarditis
Clinical narrative: Pt c/o chest pain starting on 01 or 02 JUN; he came in today 15JUN when he realized the chest pain was not resolving; symptoms were classic pericarditis with worse with laying down and resolved with leaning forward; ecg confirms pericarditis; he was sent directly to cardiology from primary care
Age: 33.0
Sex: F
Vaccine: COVID19
Symptoms: Pruritus
Clinical narrative: Itching all over
Sex: U
Vaccine: MMR, MMRV, VARCEL
Symptoms: No adverse event, Product storage error
Clinical narrative: a temperature excursion for PROQUAD, VARlVAX, and MMR II; products may have been administered; No additional AE's/PQC's noted.; This spontaneous report as received from an other reporter and refers to an unspecified number of patients of unknown age and gender. There was no information about the patients' concurrent conditions, concomitant therapies or medical histories provided. On unknown dates, the patients might have been vaccinated with improperly stored doses of: - Measles, Mumps, Rubella and Varicella (Oka-Merck) Virus Vaccine Live (PROQUAD) lot # U002540, expiration date 24-JUL-2022, - Measles, Mumps, and Rubella (Wistar RA 27-3) Virus Vaccine, Live (M-M-R II), lot # S020161, expiration date 30-JUN-2021, albumin status rHA and lot # T007230, expiration date 27-FEB-2022, albumin status rHA, - varicella virus vaccine live (Oka/Merck) (VARIVAX) lot # S033953, expiration date 24-OCT-2021 and lot # T027305, expiration date 12-AUG-2022. Doses and routes of administration were not reported. There was no adverse effect reported. Administered doses of vaccines experienced the temperature excursion of 9 to 25 (13.1) degrees Celsius for 4 hours and 26 minutes. There was no previous excursion of -10 to 8 (8.1) degrees Celsius for 1 hour and 37 minutes reported. Data logger was involved.
Sex: U
Vaccine: RV5
Symptoms: Inappropriate schedule of product administration
Clinical narrative: ROTATEQ "given more than 10 weeks later" from initial dose; This spontaneous report was received from a nurse prescriber via company representative and refers to an infant patient of unknown age and gender. There was no information about the patient's concurrent conditions, concomitant therapies or medical history provided.  On an unknown date, the patient was vaccinated with rotavirus vaccine, live, oral, pentavalent (ROTATEQ) orally (exact dose, lot # and expiration date were not reported). On an unknown date (reported as "more than 10 weeks later from initial dose"), the patient received second dose of with rotavirus vaccine, live, oral, pentavalent (ROTATEQ) orally (exact dose, lot # and expiration date were not reported) (inappropriate schedule of vaccine administered). Both vaccines were administered for prophylaxis.
Age: 0.17
Sex: F
Vaccine: RV5
Symptoms: No adverse event, Product storage error
Clinical narrative: No other AE; a temperature excursion and the ROTATEQ had been administered.; This spontaneous report was received from a medical assistant referring to a 2 months old female patient. The patient's pertinent medical history, drug reactions/ allergies and concomitant medication were not reported.  On 20-MAY-2021, the patient was vaccinated with a temperature excursion Rotavirus Vaccine, Live, Oral, Pentavalent (ROTATEQ) (lot# 1691303, expiration date 21-DEC-2021; dose, strength, frequency and route unknown) for prophylaxis (Incorrect product storage). The vaccine was stored at a temperature excursion of 34.9 Fahrenheit (F) for 2 hours. The date of excursion was 13-MAY-2021. There was no previous temperature excursion. Data logger was involved. No product quality complaint was involved. No adverse effect reported.
Sex: U
Vaccine: VARZOS
Symptoms: Erythema, Injection site inflammation, Injection site pain, Injection site swelling
Clinical narrative: injection site became swollen,; injection site became/ inflamed; injection site became /sore; redness has spread down the arm to about an inch above the elbow; This case was reported by a consumer via interactive digital media and described the occurrence of injection site swelling in a patient who received Herpes zoster (Shingrix) for prophylaxis.   On 4th June 2021, the patient received the 1st dose of Shingrix. On 5th June 2021, 1 days after receiving Shingrix, the patient experienced injection site swelling, injection site inflammation, injection site pain and erythema of extremities. On an unknown date, the outcome of the injection site swelling, injection site inflammation and injection site pain were unknown and the outcome of the erythema of extremities was not recovered/not resolved.   It was unknown if the reporter considered the injection site swelling, injection site inflammation, injection site pain and erythema of extremities to be related to Shingrix.  Additional details were provided as follows:  The patient had reported the case for himself/herself. The age at vaccination was not reported. The patient received Shingrix last Friday from the reporting date and next day injection site became swollen, inflamed and sore.  Since then the redness has spread down the arm to about an inch above the elbow. The reporter asked, was it possible that he/she had some shingles. The follow-up would be not possible, as no contact details were available.
Sex: U
Vaccine: VARZOS
Symptoms: Herpes zoster, Vaccination failure
Clinical narrative: got the vaccine, but still got shingles/Suspected vaccination failure; shingles; 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.   On an unknown date, the patient received Shingles vaccine. On an unknown date, unknown after receiving Shingles vaccine, the patient experienced vaccination failure (serious criteria GSK medically significant) and shingles. On an unknown date, the outcome of the vaccination failure and shingles were unknown.   It was unknown if the reporter considered the vaccination failure and shingles to be related to Shingles vaccine.  Additional details were provided as follows: The age at vaccination was not reported. The patient received Shingrix and had Shingles. This case was considered as suspected vaccination failure, since the details regarding the completion of the primary immunization for shingles and laboratory confirmation for herpes zoster were not provided.
Sex: U
Vaccine: VARZOS
Symptoms: Injection site erythema, Injection site pain, Injection site warmth
Clinical narrative: injection site is still red; injection site/ warm to the touch; injection site/ very tender; This case was reported by a consumer via interactive digital media and described the occurrence of injection site erythema in a patient who received Herpes zoster (Shingrix) for prophylaxis.   On 8th June 2021, the patient received the 2nd dose of Shingrix. In June 2021, less than a day after receiving Shingrix, the patient experienced injection site erythema, injection site warmth and injection site tenderness. On an unknown date, the outcome of the injection site erythema, injection site warmth and injection site tenderness were not recovered/not resolved.   It was unknown if the reporter considered the injection site erythema, injection site warmth and injection site tenderness to be related to Shingrix.  Additional details were provided as follows:  The reporter was the patient. The age at vaccination was not reported.  The patient received 2nd dose of Shingrix a little over 24 hours ago and experienced injection site redness, was warm to the touch, and very tender. The reporter asked how long should expect this to last.
Sex: U
Vaccine: MENB
Symptoms: Incomplete course of vaccination
Clinical narrative: What risk if miss second dose of Bexsero?; This case was reported by a consumer via interactive digital media and described the occurrence of incomplete course of vaccination in a patient who received Men B NVS (Bexsero) for prophylaxis.   Co-suspect products included meningococcal B recom vaccine + aloh + omv pre-filled syringe device (Bexsero Pre-Filled Syringe Device) injection syringe for prophylaxis.   Previously administered products included Bexsero (1st dose received on an unknown date).   On an unknown date, the patient received the 2nd dose of Bexsero and Bexsero Pre-Filled Syringe Device. On an unknown date, unknown after receiving Bexsero and Bexsero Pre-Filled Syringe Device, the patient experienced incomplete course of vaccination. On an unknown date, the outcome of the incomplete course of vaccination was unknown.   This report is made by GSK without prejudice and does not imply any admission or liability for the incident or its consequences.  Additional details were provided as follows:  The age at vaccination was not applicable for this report. Till the time of reporting patient did not receive 2nd dose of Shingrix, which led to incomplete course of vaccination. The patient was asking what was risk if missed second dose of Bexsero.
Sex: U
Vaccine: VARZOS
Symptoms: Herpes zoster, Vaccination failure
Clinical narrative: got the shot then got shingles/suspected vaccination failure; got shingles; 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.   On an unknown date, the patient received Shingles vaccine. On an unknown date, unknown after receiving Shingles vaccine, the patient experienced vaccination failure (serious criteria GSK medically significant) and shingles. On an unknown date, the outcome of the vaccination failure and shingles were unknown.   It was unknown if the reporter considered the vaccination failure and shingles to be related to Shingles vaccine.  Additional details were provided as follows: The age at vaccination was not reported. The patient received Shingrix and had Shingles. This case was considered as suspected vaccination failure, since the details regarding the completion of the primary immunization for shingles and laboratory confirmation for herpes zoster were not provided. This case linked with US2021AMR127128, reported by same reporter.; Sender's Comments:  US-GLAXOSMITHKLINE-US2021AMR127128:Same reporter
Sex: U
Vaccine: VARZOS
Symptoms: Herpes zoster, Vaccination failure
Clinical narrative: You can get it from the vaccination! That's how I got it./Suspected vaccination failure; You can get it from the vaccination! That's how I got it.; 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.   On an unknown date, the patient received Shingles vaccine. On an unknown date, unknown after receiving Shingles vaccine, the patient experienced vaccination failure (serious criteria GSK medically significant) and shingles. On an unknown date, the outcome of the vaccination failure and shingles were unknown.   It was unknown if the reporter considered the vaccination failure and shingles to be related to Shingles vaccine.  Additional details were provided as follows: The case was reported by patient itself. The age at vaccination was not reported. The patient got Shingles after vaccination. This case was considered as suspected vaccination failure as details regarding completion of primary vaccination schedule, laboratory confirmation, time to onset of shingles were unknown at the time of reporting.
Sex: F
Vaccine: VARZOS
Symptoms: Herpes zoster, Pain, Vaccination failure
Clinical narrative: who has received one of the shingles vaccines has gotten shingles / have a friend with it right now/ Suspected Vaccination failure; have a friend with it right now / she is in agony!; she is in agony!; This case was reported by a consumer via media and described the occurrence of suspected vaccination failure in a female patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   On an unknown date, the patient received Shingles vaccine. On an unknown date, unknown after receiving Shingles vaccine, the patient experienced vaccination failure (serious criteria GSK medically significant), shingles and pain. On an unknown date, the outcome of the vaccination failure was unknown and the outcome of the shingles and pain were not recovered/not resolved.   It was unknown if the reporter considered the vaccination failure, shingles and pain to be related to Shingles vaccine.  Additional details were reported as follows: This case was reported by patient's friend. The age at vaccination was not reported. The patient received Shingles vaccine and at the time of reporting, she had shingles and was in agony. This case was considered as suspected vaccination failure as details regarding completion of primary vaccination schedule, time to onset and laboratory test confirming herpes zoster were unknown at the time of reporting. This case had been linked with US2021AMR127615, reported by same reporter.; Sender's Comments:  US-GLAXOSMITHKLINE-US2021AMR127615:Same reporter
Sex: F
Vaccine: VARZOS
Symptoms: Herpes zoster, Vaccination failure
Clinical narrative: My mom got shingles shot and still got it 8 months later/ Suspected vaccination failure; Got shingles shot and still got it; This case was reported by a consumer via media and described the occurrence of suspected vaccination failure in a female patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   On an unknown date, the patient received Shingles vaccine. On an unknown date, 8 months 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 patient was reporter's mother. The age at vaccination was not reported. The patient received the Shingles vaccine and still got shingles 8 months later of vaccination. The reporter stated that the shots did not always prevent you from getting whatever your trying to prevent getting, unless the doctor lied about patient had Shingles. The follow-up would not possible as no contact details were available. This case was considered as suspected vaccination failure as details regarding completion of primary vaccination schedule and laboratory test confirming herpes zoster were unknown at the time of reporting.
Sex: U
Vaccine: VARZOS
Symptoms: Herpes zoster, Vaccination failure
Clinical narrative: Had the vaccine --had shingles/ Suspected vaccination failure; Shingles; 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.   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: This case was reported by patient himself/herself. The age at vaccination was not reported. The patient received the Shingles vaccine and had shingles. The follow-up would not possible as no contact details were available. This case was considered as suspected vaccination failure as details regarding completion of primary vaccination schedule, time to onset and laboratory test confirming herpes zoster were unknown at the time of reporting.
Sex: U
Vaccine: VARZOS, VARZOS
Symptoms: Herpes zoster, Vaccination failure
Clinical narrative: Got Shingles despite the 2 Doses of Shingrex/ Suspected vaccination failure; Shingles; This case was reported by a consumer via media and described the occurrence of suspected vaccination failure in a patient who received Herpes zoster (Shingrix) for prophylaxis.   Co-suspect products included Herpes zoster (Shingrix) for prophylaxis.   On an unknown date, the patient received the 1st dose of Shingrix and the 2nd dose of Shingrix. On an unknown date, unknown after receiving Shingrix and Shingrix, 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 Shingrix and Shingrix.  Additional details were reported as follows: This case was reported by patient himself/herself. The age at vaccination was not reported. The patient received 2 doses of Shinglrix and got shingles. The follow-up would not possible as no contact details were available. This case was considered as suspected vaccination failure as details regarding time to onset and laboratory test confirming herpes zoster were unknown at the time of reporting.
Sex: M
Vaccine: VARZOS
Symptoms: Incomplete course of vaccination, No adverse event
Clinical narrative: received the 1st dose / May 2019 / has not received dose 2 as of yet; This case was reported by a other health professional via call center representative and described the occurrence of incomplete course of vaccination in a 53-year-old male patient who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included Shingrix (received the 1st dose in May 2019).   On an unknown date, the patient received the 2nd dose of Shingrix. On an unknown date, unknown after receiving Shingrix, the patient experienced incomplete course of vaccination. On an unknown date, the outcome of the incomplete course of vaccination was unknown.  Additional information was provided as follow: The age at vaccination was not applicable for this report. Till the time of reporting patient did not receive 2nd dose of Shingrix vaccine, which led to incomplete course of vaccination. No adverse events reported. The reporter did not consented to follow up. The VAERS details pertains to 1st dose of Shingrix.
Age: 18.0
Sex: F
Vaccine: MENB
Symptoms: Expired product administered
Clinical narrative: administration of an expired first dose of Bexsero; This case was reported by a pharmacist via call center representative and described the occurrence of expired vaccine used in a 18-year-old female patient who received Men B NVS (Bexsero) (batch number ABXA32AB, expiry date 31st May 2021) for prophylaxis.   Co-suspect products included meningococcal B recom vaccine + aloh + omv pre-filled syringe device (Bexsero Pre-Filled Syringe Device) injection syringe for prophylaxis.   On 10th June 2021, the patient received the 1st dose of Bexsero and Bexsero Pre-Filled Syringe Device. On 10th June 2021, unknown after receiving Bexsero and Bexsero Pre-Filled Syringe Device, the patient experienced expired vaccine used. On an unknown date, the outcome of the expired vaccine used was unknown.   This report is made by GSK without prejudice and does not imply any admission or liability for the incident or its consequences.  Additional details were provided as follows:  The patient received expired first dose of Bexsero, which led to experienced expired vaccine used. No further events were reported. The reporter consent to follow up.
Sex: F
Vaccine: VARZOS
Symptoms: Incomplete course of vaccination
Clinical narrative: first dose on Feb 8th 2019 and she never received second dose; This case was reported by a pharmacist via call center representative and described the occurrence of incomplete course of vaccination in a 68-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included Shingrix (1st dose received on 8th February 2019).   On an unknown date, the patient received the 2nd dose of Shingrix. On an unknown date, unknown after receiving Shingrix, the patient experienced incomplete course of vaccination. On an unknown date, the outcome of the incomplete course of vaccination was unknown.  Additional case details were reported as follows: The age at vaccination was not applicable for this report. Till the time of reporting, patient did not receive 2nd dose of vaccine, which led to incomplete course of vaccination.  The reporter was looking for information about timing on Shingrix schedule. No data available about lot number and expiration date at the time of reporting. The reporter consented to follow up.
Sex: F
Vaccine: VARZOS
Symptoms: Incomplete course of vaccination
Clinical narrative: first dose of Shingrix in March of 2019./ not yet received the second dose.; This case was reported by a consumer via call center representative and described the occurrence of incomplete course of vaccination in a female patient who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included Shingrix (1st dose received in March 2019).   On an unknown date, the patient received the 2nd dose of Shingrix. On an unknown date, unknown after receiving Shingrix, the patient experienced incomplete course of vaccination. On an unknown date, the outcome of the incomplete course of vaccination was unknown.  Additional case details were reported as follows: The patient reported case for herself. The age at vaccination was not applicable for this report. Till the time of reporting patient did not receive 2nd dose of vaccine, which led to incomplete course of vaccination. The reporter did not consent to follow up.
Sex: F
Vaccine: COVID19
Symptoms: Thrombosis
Clinical narrative: BLOOD CLOTS; This spontaneous report received from a patient concerned a female of unspecified age, race and ethnic origin. The patient's height, and weight were not reported. No past medical history or concurrent conditions were reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: Unknown) dose, start therapy date were not reported for prophylactic vaccination. The batch number was not reported. The company is unable to perform follow-up to request batch/lot no. No concomitant medications were reported.  On an unspecified date, the patient experienced blood clots, and was hospitalized (date unspecified) for 3 to 4 weeks. Treatment medications (dates unspecified) included: Xarelto (Rivaroxaban). The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of blood clots was not reported. This report was serious (Hospitalization Caused / Prolonged).; Sender's Comments: V0 20210614970-COVID-19 VACCINE AD26.COV2.S-blood clots. This event(s) is considered unassessable. The event(s) has a compatible/suggestive temporal relationship, is unlabeled, and has unknown scientific plausibility. There is no information on any other factors potentially associated with the event(s).
Age: 55.0
Sex: F
Vaccine: COVID19
Symptoms: Abdominal pain upper, Back pain, Blood creatinine, Ear pain, Electrocardiogram
Clinical narrative: PAIN TO RIGHT SIDE OF THE NECK; NUMBNESS OF RIGHT ARM/RIGHT SIDE OF NECK/RIGHT EAR; RIGHT ARM TINGLING; PAIN TO RIGHT EAR; PAIN TO RIGHT SIDE OF GROIN; RIGHT LEG PAIN/RIGHT ARM PAIN/EXCRUCIATING PAIN THAT FELT LIKE AN INTENSE CHARLIE HORSE; HEADACHE; QUEASY FEELING THAT FELT LIKE DID 100 SIT-UPS; STOMACH PAIN; LOWER BACK PAIN; This spontaneous report received from a patient concerned a 55 year old female. The patient's weight was 135 pounds, and height was 65 inches. The patient's past medical history included thyroidectomy, and concurrent conditions included thyroid replacement medication, non alcoholic, and non smoker, and other pre-existing medical conditions included the patient was not pregnant at the time of reporting and had uses. the patient did not have any history of drug abuse or illicit drug use. the patient had no drug or non-drug allergies. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 205A21A, and batch number: 205A21A expiry: UNKNOWN) dose was not reported, administered on 09-APR-2021 for prophylactic vaccination. No concomitant medications were reported.  On 11-APR-2021, the subject experienced stomach pain. On 11-APR-2021, the subject experienced lower back pain. On 11-APR-2021, the subject experienced headache. On 11-APR-2021, the subject experienced queasy feeling that felt like did 100 sit-ups. Laboratory data included: Pain scale (NR: not provided) 5/10, 3/10, 1/10. On 15-APR-2021, the subject experienced right leg pain/right arm pain/excruciating pain that felt like an intense charlie horse. On 24-APR-2021, the subject experienced pain to right side of the neck. On 24-APR-2021, the subject experienced numbness of right arm/right side of neck/right ear. On 24-APR-2021, the subject experienced right arm tingling. On 24-APR-2021, the subject experienced pain to right ear. On 24-APR-2021, the subject experienced pain to right side of groin. On 25-APR-2021, Laboratory data included: Basic metabolic panel (NR: not provided) Normal, CBC (NR: not provided) Normal, Creatinine (NR: not provided) Normal, Laboratory test (NR: not provided) Normal, and Thyroid function test (NR: not provided) Normal. On 26-APR-2021, Laboratory data included: ECG (NR: not provided) Normal. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from stomach pain, lower back pain, headache, and queasy feeling that felt like did 100 sit-ups on 20-APR-2021, and pain to right side of the neck, numbness of right arm/right side of neck/right ear, right arm tingling, pain to right ear, pain to right side of groin, and right leg pain/right arm pain/excruciating pain that felt like an intense charlie horse on 05-MAY-2021. This report was non-serious.
Age: 55.0
Sex: F
Vaccine: COVID19
Symptoms: Full blood count, Groin pain, Headache, Hypoaesthesia, Laboratory test
Clinical narrative: PAIN TO RIGHT SIDE OF THE NECK; NUMBNESS OF RIGHT ARM/RIGHT SIDE OF NECK/RIGHT EAR; RIGHT ARM TINGLING; PAIN TO RIGHT EAR; PAIN TO RIGHT SIDE OF GROIN; RIGHT LEG PAIN/RIGHT ARM PAIN/EXCRUCIATING PAIN THAT FELT LIKE AN INTENSE CHARLIE HORSE; HEADACHE; QUEASY FEELING THAT FELT LIKE DID 100 SIT-UPS; STOMACH PAIN; LOWER BACK PAIN; This spontaneous report received from a patient concerned a 55 year old female. The patient's weight was 135 pounds, and height was 65 inches. The patient's past medical history included thyroidectomy, and concurrent conditions included thyroid replacement medication, non alcoholic, and non smoker, and other pre-existing medical conditions included the patient was not pregnant at the time of reporting and had uses. the patient did not have any history of drug abuse or illicit drug use. the patient had no drug or non-drug allergies. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 205A21A, and batch number: 205A21A expiry: UNKNOWN) dose was not reported, administered on 09-APR-2021 for prophylactic vaccination. No concomitant medications were reported.  On 11-APR-2021, the subject experienced stomach pain. On 11-APR-2021, the subject experienced lower back pain. On 11-APR-2021, the subject experienced headache. On 11-APR-2021, the subject experienced queasy feeling that felt like did 100 sit-ups. Laboratory data included: Pain scale (NR: not provided) 5/10, 3/10, 1/10. On 15-APR-2021, the subject experienced right leg pain/right arm pain/excruciating pain that felt like an intense charlie horse. On 24-APR-2021, the subject experienced pain to right side of the neck. On 24-APR-2021, the subject experienced numbness of right arm/right side of neck/right ear. On 24-APR-2021, the subject experienced right arm tingling. On 24-APR-2021, the subject experienced pain to right ear. On 24-APR-2021, the subject experienced pain to right side of groin. On 25-APR-2021, Laboratory data included: Basic metabolic panel (NR: not provided) Normal, CBC (NR: not provided) Normal, Creatinine (NR: not provided) Normal, Laboratory test (NR: not provided) Normal, and Thyroid function test (NR: not provided) Normal. On 26-APR-2021, Laboratory data included: ECG (NR: not provided) Normal. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from stomach pain, lower back pain, headache, and queasy feeling that felt like did 100 sit-ups on 20-APR-2021, and pain to right side of the neck, numbness of right arm/right side of neck/right ear, right arm tingling, pain to right ear, pain to right side of groin, and right leg pain/right arm pain/excruciating pain that felt like an intense charlie horse on 05-MAY-2021. This report was non-serious.
Age: 55.0
Sex: F
Vaccine: COVID19
Symptoms: Metabolic function test, Nausea, Neck pain, Pain assessment, Pain in extremity
Clinical narrative: PAIN TO RIGHT SIDE OF THE NECK; NUMBNESS OF RIGHT ARM/RIGHT SIDE OF NECK/RIGHT EAR; RIGHT ARM TINGLING; PAIN TO RIGHT EAR; PAIN TO RIGHT SIDE OF GROIN; RIGHT LEG PAIN/RIGHT ARM PAIN/EXCRUCIATING PAIN THAT FELT LIKE AN INTENSE CHARLIE HORSE; HEADACHE; QUEASY FEELING THAT FELT LIKE DID 100 SIT-UPS; STOMACH PAIN; LOWER BACK PAIN; This spontaneous report received from a patient concerned a 55 year old female. The patient's weight was 135 pounds, and height was 65 inches. The patient's past medical history included thyroidectomy, and concurrent conditions included thyroid replacement medication, non alcoholic, and non smoker, and other pre-existing medical conditions included the patient was not pregnant at the time of reporting and had uses. the patient did not have any history of drug abuse or illicit drug use. the patient had no drug or non-drug allergies. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 205A21A, and batch number: 205A21A expiry: UNKNOWN) dose was not reported, administered on 09-APR-2021 for prophylactic vaccination. No concomitant medications were reported.  On 11-APR-2021, the subject experienced stomach pain. On 11-APR-2021, the subject experienced lower back pain. On 11-APR-2021, the subject experienced headache. On 11-APR-2021, the subject experienced queasy feeling that felt like did 100 sit-ups. Laboratory data included: Pain scale (NR: not provided) 5/10, 3/10, 1/10. On 15-APR-2021, the subject experienced right leg pain/right arm pain/excruciating pain that felt like an intense charlie horse. On 24-APR-2021, the subject experienced pain to right side of the neck. On 24-APR-2021, the subject experienced numbness of right arm/right side of neck/right ear. On 24-APR-2021, the subject experienced right arm tingling. On 24-APR-2021, the subject experienced pain to right ear. On 24-APR-2021, the subject experienced pain to right side of groin. On 25-APR-2021, Laboratory data included: Basic metabolic panel (NR: not provided) Normal, CBC (NR: not provided) Normal, Creatinine (NR: not provided) Normal, Laboratory test (NR: not provided) Normal, and Thyroid function test (NR: not provided) Normal. On 26-APR-2021, Laboratory data included: ECG (NR: not provided) Normal. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from stomach pain, lower back pain, headache, and queasy feeling that felt like did 100 sit-ups on 20-APR-2021, and pain to right side of the neck, numbness of right arm/right side of neck/right ear, right arm tingling, pain to right ear, pain to right side of groin, and right leg pain/right arm pain/excruciating pain that felt like an intense charlie horse on 05-MAY-2021. This report was non-serious.
Age: 55.0
Sex: F
Vaccine: COVID19
Symptoms: Paraesthesia, Thyroid function test
Clinical narrative: PAIN TO RIGHT SIDE OF THE NECK; NUMBNESS OF RIGHT ARM/RIGHT SIDE OF NECK/RIGHT EAR; RIGHT ARM TINGLING; PAIN TO RIGHT EAR; PAIN TO RIGHT SIDE OF GROIN; RIGHT LEG PAIN/RIGHT ARM PAIN/EXCRUCIATING PAIN THAT FELT LIKE AN INTENSE CHARLIE HORSE; HEADACHE; QUEASY FEELING THAT FELT LIKE DID 100 SIT-UPS; STOMACH PAIN; LOWER BACK PAIN; This spontaneous report received from a patient concerned a 55 year old female. The patient's weight was 135 pounds, and height was 65 inches. The patient's past medical history included thyroidectomy, and concurrent conditions included thyroid replacement medication, non alcoholic, and non smoker, and other pre-existing medical conditions included the patient was not pregnant at the time of reporting and had uses. the patient did not have any history of drug abuse or illicit drug use. the patient had no drug or non-drug allergies. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 205A21A, and batch number: 205A21A expiry: UNKNOWN) dose was not reported, administered on 09-APR-2021 for prophylactic vaccination. No concomitant medications were reported.  On 11-APR-2021, the subject experienced stomach pain. On 11-APR-2021, the subject experienced lower back pain. On 11-APR-2021, the subject experienced headache. On 11-APR-2021, the subject experienced queasy feeling that felt like did 100 sit-ups. Laboratory data included: Pain scale (NR: not provided) 5/10, 3/10, 1/10. On 15-APR-2021, the subject experienced right leg pain/right arm pain/excruciating pain that felt like an intense charlie horse. On 24-APR-2021, the subject experienced pain to right side of the neck. On 24-APR-2021, the subject experienced numbness of right arm/right side of neck/right ear. On 24-APR-2021, the subject experienced right arm tingling. On 24-APR-2021, the subject experienced pain to right ear. On 24-APR-2021, the subject experienced pain to right side of groin. On 25-APR-2021, Laboratory data included: Basic metabolic panel (NR: not provided) Normal, CBC (NR: not provided) Normal, Creatinine (NR: not provided) Normal, Laboratory test (NR: not provided) Normal, and Thyroid function test (NR: not provided) Normal. On 26-APR-2021, Laboratory data included: ECG (NR: not provided) Normal. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from stomach pain, lower back pain, headache, and queasy feeling that felt like did 100 sit-ups on 20-APR-2021, and pain to right side of the neck, numbness of right arm/right side of neck/right ear, right arm tingling, pain to right ear, pain to right side of groin, and right leg pain/right arm pain/excruciating pain that felt like an intense charlie horse on 05-MAY-2021. This report was non-serious.
Sex: M
Vaccine: COVID19
Symptoms: Chest discomfort, Cough, Fatigue, Feeling abnormal
Clinical narrative: DISCOMFORT IN CHEST; SLIGHT COUGH; EXTREME FATIGUE FOR 2 WEEKS; FELT OFF; This spontaneous report received from a patient concerned a male of unspecified age. The patient's height, and weight were not reported. No past medical history or concurrent conditions were reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin, and batch number were not reported) dose was not reported, administered on MAY-2021 for prophylactic vaccination. The batch number was not reported and has been requested. No concomitant medications were reported.  On MAY-2021, the subject experienced felt off. On MAY-2021, the subject experienced extreme fatigue for 2 weeks. On JUN-2021, the subject experienced discomfort in chest. On JUN-2021, the subject experienced slight cough. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from extreme fatigue for 2 weeks, and was recovering from felt off, discomfort in chest, and slight cough. This report was non-serious.