chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Sex: U
Vaccine: MMRV, VARCEL
Symptoms: Extra dose administered
Clinical narrative: One patient received both VARIVAX and PROQUAD today due to a human error; This spontaneous report was received from a physician concerning a 2 year old patient. Information regarding the patient's medical history, concurrent conditions and concomitant medications was not reported.       On 03-JUN-2021, the patient was vaccinated with varicella virus vaccine live (oka/merck)(VARIVAX) and with measles, mumps, rubella and varicella (oka-merck) virus vaccine live (PROQUAD) (duplicate therapy error) both for prophylaxis (strength, dose, route of administration, anatomical location, lot number and expiration date were not provided for the vaccines).
Sex: U
Vaccine: VARZOS
Symptoms: Emotional distress, Herpes zoster, Physical disability
Clinical narrative: shingles; Information has been received from a lawyer regarding a case in litigation which referred to a patient (pt) of unknown gender and age. Information regarding concomitant medications, concurrent conditions or medical history was not provided. In or around April 2014, the patient was vaccinated with zoster vaccine live (ZOSTAVAX) for its intended purpose: the prevention of shingles (herpes zoster) and for routine health maintenance (exact dose, dose number, route of administration, anatomical site of vaccination, lot number and expiration date were not provided). Afterwards, on an unknown date (reported as after receiving zoster vaccine live (ZOSTAVAX) vaccine), the patient suffered shingles (herpes zoster). As a direct and proximate result of zoster vaccine live (ZOSTAVAX) vaccine, the pt's symptoms had resulted in physical limitations not present prior to using zoster vaccine live (ZOSTAVAX). The patient also experienced mental and emotional distress due to resulting physical limitations and seriousness of pt's condition. In addition, the pt sustained severe and permanent personal injuries. Further, the pt had suffered serious, progressive, permanent, and incurable injuries, as well as significant conscious pain and suffering, mental anguish, emotional distress, loss of enjoyment of life, physical impairment and injury. Finally, as direct and proximate result of zoster vaccine live (ZOSTAVAX), the pt had suffered and incurred damages, including medical expenses; the loss of accumulations; and other economic and non-economic damages. The outcome of the event was considered as not recovered. The causal relationship between the event and zoster vaccine live (ZOSTAVAX) was assessed as related.  Herpes zoster was considered as a disabling event by the reporter.
Sex: M
Vaccine: VARZOS
Symptoms: Blindness, Herpes zoster
Clinical narrative: vision loss; shingles; Information has been received from a lawyer regarding a case in litigation referring to a male patient (pt) of unknown age. Information about concurrent condition, medical history and concomitant medication was not reported. In or around February 2015, the pt was vaccinated with zoster vaccine live (ZOSTAVAX) (strength, dose, lot#, expiration date and route unknown) for routine health maintenance and for its intended purpose: the prevention of shingles (herpes zoster). Shortly after receiving the vaccine, the pt suffered shingles and vision loss. As a direct and proximate result of zoster vaccine live (ZOSTAVAX), the pt's symptoms had resulted in physical limitations not present prior to using the product. The pt also experienced mental and emotional distress due to resulting physical limitations and seriousness of his condition. As a result of the manufacture, marketing, advertising, promotion, distribution and/or sale of zoster vaccine live (ZOSTAVAX), the pt sustained severe and permanent personal injuries. Further, as a tragic consequence of the conduct, the pt suffered serious, progressive, permanent, and incurable injuries, as well as significant conscious pain and suffering, mental anguish, emotional distress, loss of enjoyment of life, physical impairment and injury. As a direct and proximate result of the product, the pt had suffered and incurred damages, including medical expenses; the loss of accumulations; and other economic and non-economic damages. The outcome of the events shingles and vision loss was not recovered. The causality assessment was considered as related by the lawyer.  Upon internal review, vision loss was determined to be medically significant.  The events shingles and vision loss were considered to be disabling by the lawyer.
Sex: U
Vaccine: PPV
Symptoms: No adverse event, Product storage error
Clinical narrative: No Additional adverse effect reported.; PNEUMOVAX 23(syringe), that experienced a temperature excursion was administered.; This spontaneous report was received from an administrator and refers to a patient of unknown age and gender. There was no information about the patient's concurrent conditions, concomitant therapies or medical history provided.  On 03-JUN-2021, the patient was vaccinated with an improperly stored dose of pneumococcal vaccine, polyvalent (23-valent) (PNEUMOVAX23) lot # T034630 has been verified to be a valid lot number, expiration date 22-JUN-2022 (dose, route of administration, anatomical location were not reported) for prophylaxis. Administered dose of vaccine was stored above 9 degree Celsius (9.1 C) for 46 minutes.. There was no previous temperature excursions reported. The digital data logger was involved. No adverse effects were reported. combinationproductreport: Yes; brandname: PNEUMOVAX23 SYRINGE (DEVICE); commondevicename: Pneumococcal Vaccine, Polyvalent (23-valent); productcode: FMF; devicetype: SYRINGE, PISTON (FMF); manufacturername: Merck Sharp & Dohme Corp.; devicelotnumber: T034630; expirationdate: 22-JUN-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: HEP, HEPA
Symptoms: No adverse event, Product storage error
Clinical narrative: No Additional adverse effect reported.; RECOMBIVAX HB and VAQTA that experienced a temperature excursion were administered.; This spontaneous report was received from an administrator and refers to a patient of unknown age and gender. There was no information about the patient's concurrent conditions, concomitant therapies or medical history provided.  On 03-JUN-2021, the patient was vaccinated with improperly stored doses of hepatitis b vaccine (recombinant)(RECOMBIVAX HB) lot #T025374 has been verified to be a valid lot number, expiration date 25-JAN-2023 (dose, route of administration, anatomical location were not reported) and hepatitis a vaccine, inactivated (VAQTA) lot #T036739 has been verified to be a valid lot number, expiration date 22-APR-2022 (dose, route of administration, anatomical location were not reported); both for prophylaxis. Administered doses of vaccines were stored above 9 degree Celsius (9.1 C) for 46 minutes. There was no previous temperature excursions reported. The digital data logger was involved. No adverse effects were reported.
Sex: U
Vaccine: VARZOS
Symptoms: Blindness, Eye pain, Herpes zoster, Ophthalmic herpes zoster
Clinical narrative: vision loss; herpes zoster ophthalmicus; herpes zoster; This spontaneous report was received from a lawyer regarding a case in litigation and refers to a patient (pt) of unknown age and gender. The pt's medical history, concurrent conditions and concomitant medications were not reported.  On or about 17-JUL-2010, the patient was vaccinated with zoster vaccine live (ZOSTAVAX) in a pharmacy (exact dose, site and route of administration, lot# and expiration date were not reported) for the long-term prevention of shingles and zoster-related conditions. Subsequently, on an unknown date, the pt was treated for the following injuries resulting from zoster vaccine live (ZOSTAVAX) use: herpes zoster, vision loss, eye pain and herpes zoster ophthalmicus. The outcome of the events was unknown. The relatedness between the events and zoster vaccine live (ZOSTAVAX) was related.  Upon internal review, the events of vision loss and herpes zoster ophthalmicus were determined to be medically significant.
Sex: M
Vaccine: VARZOS
Symptoms: Optic ischaemic neuropathy, Sudden visual loss
Clinical narrative: Anterior Ischemic Optic Neuropathy; This spontaneous report was received from a lawyer regarding a case in litigation and refers to a male patient (pt) of unknown age. The pt's medical history, concurrent conditions and concomitant medications were not reported.  On or around 28-SEP-2017, the pt was vaccinated with zoster vaccine live (ZOSTAVAX) (exact dose, site and route of administration, lot# and expiration date were not reported) for routine health maintenance and for its intended purpose: the prevention of shingles (herpes zoster). Shortly after receiving zoster vaccine live (ZOSTAVAX), the pt suffered sudden visual loss of his right eye and was diagnosed with anterior ischemic optic neuropathy in his right eye. As a direct and proximate result of zoster vaccine live (ZOSTAVAX) vaccine, the pt's symptoms had results in physical limitations not present prior to using zoster vaccine live (ZOSTAVAX). The pt also experienced mental and emotional distress due to resulting physical limitations and seriousness of his condition. As a result of the manufacture, marketing, advertising, promotion, distribution and/or sale of zoster vaccine live (ZOSTAVAX), the pt sustained severe and permanent personal injuries. Further, as a tragic consequence of zoster vaccine live (ZOSTAVAX) vaccination, the pt suffered serious, progressive, permanent and incurable injuries, as well as significant conscious pain and suffering, mental anguish, emotional distress, loss of enjoyment of life and physical impairment and injury. As a direct and proximate result of zoster vaccine live (ZOSTAVAX), the pt had suffered and incurred damages, including medical expenses, the loss of accumulations and other economic and non-economic damages. The outcome of the event was unknown. The relatedness between the event and zoster vaccine live (ZOSTAVAX) was related.  Upon internal review, the event anterior ischemic optic neuropathy was considered to be medically significant. The event was also considered to be disabling by the reporter.
Age: 25.0
Sex: M
Vaccine: HPV9
Symptoms: Anogenital warts, Incomplete course of vaccination, Papilloma viral infection
Clinical narrative: patient received GARDASIL 9 vaccine in 2015 and never received dose 2 or 3; genital warts; recently diagnosed with HPV; This spontaneous report as received from a physician refers to an approximately 31-year-old male patient. There was no information about the patient's medical history, concurrent conditions or concomitant medication. In 2015 the patient was vaccinated with a first  dose of  hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast)(GARDASIL 9) for prophylaxis for prophylaxis (dose, route of administration, lot number and expiration date were not reported). It was reported that the patient never received the second or third dose of hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast)(GARDASIL 9).  Approximately in June 2021, reported as recently,  the patient was diagnosed with human papilloma virus infection and genital warts. The outcome of anogenital warts, and papilloma viral infection was unknown.The causality assessment for human papilloma virus infection and genital warts was not reported.
Age: 61.0
Sex: F
Vaccine: COVID19
Symptoms: Diarrhoea, Haematochezia, Loss of consciousness, Nausea
Clinical narrative: Haematochezia; Loss of consciousness; Diarrhoea; Nausea; This case was received via FDA VAERS on 01-Jun-2021 and was forwarded to Moderna on 01-Jun-2021.    This regulatory authority case was reported by an other health care professional and describes the occurrence of HAEMATOCHEZIA (Haematochezia) and LOSS OF CONSCIOUSNESS (Loss of consciousness) in a 61-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 040A21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     Concurrent medical conditions included Drug allergy (Allergy to antihistamines.) and Diabetes.   On 22-Mar-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 29-Mar-2021, the patient experienced HAEMATOCHEZIA (Haematochezia) (seriousness criterion medically significant), LOSS OF CONSCIOUSNESS (Loss of consciousness) (seriousness criterion medically significant), DIARRHOEA (Diarrhoea) and NAUSEA (Nausea). At the time of the report, HAEMATOCHEZIA (Haematochezia), LOSS OF CONSCIOUSNESS (Loss of consciousness), DIARRHOEA (Diarrhoea) and NAUSEA (Nausea) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown Route), the reporter did not provide any causality assessments.   The patient reported blood in her stool.  Concomitant products were not provided.  Treatment medication were not reported.  Based on the current available information and temporal association between the use of the product and the events, a causal relationship cannot be excluded.  Event terms, onset dates and outcomes captured per Authority reporting.  Events seriousness per IME list; Sender's Comments: Based on the current available information and temporal association between the use of the product and the events, a causal relationship cannot be excluded.  Event terms, onset dates and outcomes captured per Authority reporting.  Events seriousness per IME list
Sex: F
Vaccine: COVID19
Symptoms: Amnesia, Headache, Magnetic resonance imaging, Muscular weakness, Viral test
Clinical narrative: Amnesia; Muscular weakness; Headache; This case was received via VAERS (Reference number: 1247184) on 01-Jun-2021 and was forwarded to Moderna on 01-Jun-2021.    This regulatory authority case was reported by an other health care professional and describes the occurrence of AMNESIA (Amnesia), MUSCULAR WEAKNESS (Muscular weakness) and HEADACHE (Headache) in a 41-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 020b21a) for COVID-19 vaccination.     The patient's past medical history included Lumbar puncture (Spinal tap for CSF fluid.). Concurrent medical conditions included Hypertension, Depression and Guillain Barre syndrome. Concomitant products included CITALOPRAM HYDROCHLORIDE (CITALOPRAM [CITALOPRAM HYDROCHLORIDE]) for COVID-19 vaccination, ATENOLOL and HYDROXYZINE EMBONATE (VISTARIL [HYDROXYZINE EMBONATE]) for an unknown indication.    On 31-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 02-Apr-2021, the patient experienced AMNESIA (Amnesia) (seriousness criterion hospitalization), MUSCULAR WEAKNESS (Muscular weakness) (seriousness criterion hospitalization) and HEADACHE (Headache) (seriousness criterion hospitalization). At the time of the report, AMNESIA (Amnesia), MUSCULAR WEAKNESS (Muscular weakness) and HEADACHE (Headache) had resolved.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 02-Apr-2021, Magnetic resonance imaging: normal (normal) MRI was normal. On 02-Apr-2021, Viral test: inconclusive (Inconclusive) result given recovered/resolved.. On 02-Apr-2021, X-ray: normal (normal) x-ray result showed no tumors..     The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   Treatment medication include high dose steroids and on 02-APR-2021 immunoglobulin therapy.  Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded.; Sender's Comments: Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded.
Sex: F
Vaccine: COVID19
Symptoms: X-ray
Clinical narrative: Amnesia; Muscular weakness; Headache; This case was received via VAERS (Reference number: 1247184) on 01-Jun-2021 and was forwarded to Moderna on 01-Jun-2021.    This regulatory authority case was reported by an other health care professional and describes the occurrence of AMNESIA (Amnesia), MUSCULAR WEAKNESS (Muscular weakness) and HEADACHE (Headache) in a 41-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 020b21a) for COVID-19 vaccination.     The patient's past medical history included Lumbar puncture (Spinal tap for CSF fluid.). Concurrent medical conditions included Hypertension, Depression and Guillain Barre syndrome. Concomitant products included CITALOPRAM HYDROCHLORIDE (CITALOPRAM [CITALOPRAM HYDROCHLORIDE]) for COVID-19 vaccination, ATENOLOL and HYDROXYZINE EMBONATE (VISTARIL [HYDROXYZINE EMBONATE]) for an unknown indication.    On 31-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 02-Apr-2021, the patient experienced AMNESIA (Amnesia) (seriousness criterion hospitalization), MUSCULAR WEAKNESS (Muscular weakness) (seriousness criterion hospitalization) and HEADACHE (Headache) (seriousness criterion hospitalization). At the time of the report, AMNESIA (Amnesia), MUSCULAR WEAKNESS (Muscular weakness) and HEADACHE (Headache) had resolved.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 02-Apr-2021, Magnetic resonance imaging: normal (normal) MRI was normal. On 02-Apr-2021, Viral test: inconclusive (Inconclusive) result given recovered/resolved.. On 02-Apr-2021, X-ray: normal (normal) x-ray result showed no tumors..     The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   Treatment medication include high dose steroids and on 02-APR-2021 immunoglobulin therapy.  Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded.; Sender's Comments: Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded.
Sex: M
Vaccine: VARZOS
Symptoms: Extra dose administered
Clinical narrative: got first dose / may have had the series about 3 years ago / any danger to getting this twice?; This case was reported by a consumer via interactive digital media and described the occurrence of extra dose administered in a male patient who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included Shingrix (might had the series about 3 years ago from the date of reporting).   On an unknown date, the patient received Shingrix. On an unknown date, unknown after receiving Shingrix, the patient experienced extra dose administered. On an unknown date, the outcome of the extra dose administered was unknown.  Additional details were provided as follows: The reporter was the patient's wife. The age at vaccination was not reported. The patient's wife stated that, they thought, the patient might have the series about 3 years ago from the date reporting and still got the Shingrix which led to extra dose administered. She asked, was there any danger to getting this twice.
Sex: U
Vaccine: VARZOS
Symptoms: Incomplete course of vaccination
Clinical narrative: WHAT IF IS HAS BEEN 9 MONTHS SINCE MY FIRST SHOT WILL THE SECOND ONE BE AFFECTIVE / DO I REQUIRE TO START OVER/?; 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 Herpes zoster (Shingles vaccine) for prophylaxis.   Previously administered products included Shingles vaccine (1st dose of Shingrix received 9 month ago).   On an unknown date, the patient received the 2nd dose of Shingles vaccine. On an unknown date, unknown after receiving Shingles vaccine, the patient experienced incomplete course of vaccination. On an unknown date, the outcome of the incomplete course of vaccination was unknown.  Additional details were provided as follows: The case was reported by the consumer for herself or himself. The age at vaccination was not applicable for this report. Till the time of reporting, the patient did not receive the 2nd dose of Shingix, which led to incomplete course of vaccination. The patient asked, would be the second dose affective or he or she required to start over the procedure of first shot. No further information was reported.
Sex: U
Vaccine: VARZOS
Symptoms: Incomplete course of vaccination
Clinical narrative: first dose of the Shingrix/ in August 2018.Can I still get the second dose or due I need to receive both doses again; This case was reported by a consumer via (Shingrix GSK Chatbot) interactive digital media and described the occurrence of incomplete course of vaccination in a patient who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included Shingrix (1st dose of Shingrix received in August 2018).   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 details were provided as follows: The case was reported by the patient for herself/himself. The age at vaccination was not applicable for this report. Till the time of reporting, the patient did not receive the 2nd dose of Shingrix , which led to incomplete course of vaccination. The patient asked, can he or she still get the second dose or the patient need to receive both the doses again. No further information was reported.
Age: 0.17
Sex: F
Vaccine: DTAPHEPBIP, HEP, IPV
Symptoms: Extra dose administered
Clinical narrative: was vaccinated / with Pediarix / on that same day, by confusion / was also vaccinated with Engerix-B / and with Polio vaccine; This case was reported by a nurse via call center representative and described the occurrence of accidental overdose in a 2-month-old female patient who received HBV (Engerix B pediatric) (batch number 7574E, expiry date 29th December 2022) for prophylaxis.   Co-suspect products included hepatitis B vaccine pre-filled syringe device (Engerix B Pre-Filled Syringe Device) injection syringe for prophylaxis, DTPa-HBV-IPV (Pediarix) (batch number 9X3T5, expiry date 5th March 2023) for prophylaxis, dtpa-hbv-ipv vaccine pre-filled syringe device (Pediarix Pre-Filled Syringe Device) injection syringe for prophylaxis and POLIOMYELITIS VACCINE (POLIO VACCINE) for prophylaxis.   On 3rd June 2021, the patient received Engerix B pediatric, Engerix B Pre-Filled Syringe Device, Pediarix and Pediarix Pre-Filled Syringe Device. On an unknown date, the patient received POLIO VACCINE. On 3rd June 2021, unknown after receiving Engerix B pediatric, Engerix B Pre-Filled Syringe Device, Pediarix, Pediarix Pre-Filled Syringe Device and POLIO VACCINE, the patient experienced accidental overdose. On an unknown date, the outcome of the accidental overdose 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 nurse called to report that the patient was vaccinated with Pediarix afterwards on that same day, by confusion was also vaccinated with Engerix-B and with Polio vaccine from Sanofi Pasteur, which led to accidental overdose. The Healthcare professional did not know the brand name of the vaccine at the time of the call.  No further events were reported at the time of the phone call. The reporter did not consent to follow up. The Healthcare professional did not consent nor decline follow up and wanted to know on how to proceed. No further details were provided at the time of the phone call.
Age: 55.0
Sex: F
Vaccine: VARZOS
Symptoms: Abdominal pain, Diarrhoea haemorrhagic, Nausea, Pyrexia, Vomiting
Clinical narrative: Bloody diarrhea; Nausea with vomiting; Nausea with vomiting; Abdominal cramps; Fever; This case was reported by a pharmacist via call center representative and described the occurrence of bloody diarrhea in a 55-year-old female patient who received Herpes zoster (Shingrix) (batch number BA5GK, expiry date 4th November 2022) for prophylaxis.   On 6th June 2021, the patient received the 1st dose of Shingrix (intramuscular) .5 ml. In June 2021, less than a day after receiving Shingrix, the patient experienced bloody diarrhea (serious criteria GSK medically significant), nausea, vomiting, abdominal cramp and fever. On an unknown date, the outcome of the bloody diarrhea, nausea, vomiting, abdominal cramp and fever were not recovered/not resolved.   It was unknown if the reporter considered the bloody diarrhea, nausea, vomiting, abdominal cramp and fever to be related to Shingrix.  Additional details were provided as follows: Health care professional called on behalf of patient.  A day before reporting, the patient received 1st dose of Shingrix and on the day of reporting, the side effects experienced were nausea with vomiting, abdominal cramps, fever and bloody diarrhea. Symptoms were started within 24 hours of receiving the vaccine and were not resolved. Call transferred to Medical Information for follow up. Instructed to have patients follow up with their Health care professional. The reporter did not consent to follow-up. This case had been linked with the case US2021AMR123236 (patient's husband), reported by same reporter.; Sender's Comments:  US-GLAXOSMITHKLINE-US2021AMR123236:Same reporter. Husband's case.
Sex: U
Vaccine: VARZOS
Symptoms: Incomplete course of vaccination
Clinical narrative: first dose of Shingrix in december 2019 and has not received a second dose; This case was reported by a other health professional via call center representative and described the occurrence of incomplete course of vaccination in a patient who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included Shingrix (received 1st dose in December 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 details were provided as follows:  The age at vaccination was not applicable for this report. The medical assistant reported the case. Till the time of reporting patient not received second dose of Shingrix, which led to incomplete course of vaccination. The reporter did not consented to follow up.
Age: 1.5
Sex: F
Vaccine: DTAP, DTAPHEPBIP
Symptoms: Extra dose administered, No adverse event
Clinical narrative: administrated with Infanrix and Pediarix on the same day; This case was reported by a nurse via call center representative and described the occurrence of overdose in a 18-month-old female patient who received DTPa (Infanrix) (batch number 5RM39, expiry date 25th November 2022) for prophylaxis.   Co-suspect products included dtpa vaccine pre-filled syringe device (Infanrix Pre-Filled Syringe Device) injection syringe for prophylaxis, DTPa-HBV-IPV (Pediarix) (batch number TN7S9, expiry date 29th May 2022) for prophylaxis and dtpa-hbv-ipv vaccine pre-filled syringe device (Pediarix Pre-Filled Syringe Device) injection syringe for prophylaxis.   On 7th June 2021, the patient received Infanrix, Infanrix Pre-Filled Syringe Device, Pediarix and Pediarix Pre-Filled Syringe Device. On 7th June 2021, unknown after receiving Infanrix, Infanrix Pre-Filled Syringe Device, Pediarix and Pediarix Pre-Filled Syringe Device, the patient experienced overdose. On an unknown date, the outcome of the overdose 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: Nurse reported that a patient was administrated with Infanrix and Pediarix on the same day, which led to overdose. No adverse event was reported . The reporter consented to follow up.
Sex: M
Vaccine: VARZOS
Symptoms: Economic problem, Incomplete course of vaccination
Clinical narrative: 1st dose/ December 29th 2020/second dose has not been received yet.; This case was reported by a pharmacist via call center representative and described the occurrence of incomplete course of vaccination in a adult male patient who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included Shingrix (received 1st dose of Shingrix on  29th December 2020).   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 details were reported as follow: This case was reported by a Pharmacist. The pharmacist reported on 7th June 2021 that the male patient received 1st dose of Shingrix on 29th December 2020. The patient did not received second dose yet which led to incomplete course of vaccination. The patient wanted to delay the 2nd dose due to financial issues.
Age: 4.0
Sex: M
Vaccine: MENB
Symptoms: Product administered to patient of inappropriate age
Clinical narrative: Patient 4 years of age, received / a dose of Bexsero by mistake; This case was reported by a nurse via call center representative and described the occurrence of inappropriate age at vaccine administration in a 4-year-old male patient who received Men B NVS (Bexsero) (batch number ABXB26AB, expiry date 30th June 2022) 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 7th June 2021, the patient received the 1st dose of Bexsero and Bexsero Pre-Filled Syringe Device. On 7th June 2021, unknown after receiving Bexsero and Bexsero Pre-Filled Syringe Device, the patient experienced inappropriate age at vaccine administration. On an unknown date, the outcome of the inappropriate age at vaccine administration 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 information was provided as follows: The licensed practical nurse reported that, the patient received a dose of Bexsero at an age of 4 years old  by mistake, which led to inappropriate age at vaccine administration. The reporter did not consent to follow up. As per sales data sheet reported batch number was changed from AVXB268V to ABXB26AB.
Age: 0.17
Sex: M
Vaccine: RV1
Symptoms: Incorrect dose administered, Product preparation issue
Clinical narrative: Received Rotarix without reconstitute with the powder / only / diluent; Received Rotarix without reconstitute with the powder / only / diluent; This case was reported by a nurse via call center representative and described the occurrence of inappropriate preparation of medication in a 2-month-old male patient who received Rota (Rotarix lyophilized formulation) (batch number H395H, expiry date 30th September 2022) for prophylaxis.   Co-suspect products included rotavirus vaccine oral applicator device (Rotarix Oral Applicator Device) oral applicator for prophylaxis.   On 7th June 2021, the patient received Rotarix lyophilized formulation (oral) and Rotarix Oral Applicator Device. On 7th June 2021, unknown after receiving Rotarix lyophilized formulation and Rotarix Oral Applicator Device, the patient experienced inappropriate preparation of medication and inappropriate dose of vaccine administered. On an unknown date, the outcome of the inappropriate preparation of medication and inappropriate dose of vaccine administered were unknown.   This report is made without prejudice and does not imply any admission or liability for the incident or its consequences.  Additional details were provided as follows: Nurse reported that the patient received Rotarix without reconstitute with the powder, only the diluent component was administered, which led to inappropriate preparation of medication and inappropriate dose of vaccine administered. No other information was provided. The reporter consented to follow up.
Sex: M
Vaccine: VARZOS
Symptoms: Incomplete course of vaccination
Clinical narrative: received first dose of shingrix on 23 july 2018, never got 2nd dose; This case was reported by a pharmacist via call center representative and described the occurrence of incomplete course of vaccination in a 72-year-old male patient who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included Shingrix (received 1st dose on 23rd July 2018, batch number ZG47A, expiry date 12th February 2021).   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 details were provided as follows: The age at vaccination was not applicable for this report. The patient received 1st dose of Shingrix and did not receive 2nd dose, which led to incomplete course of vaccination. The patient never got 2nd dose. The reporter enquired to restart series or one dose should be given. The reporter consented to follow up.
Sex: F
Vaccine: VARZOS
Symptoms: Incomplete course of vaccination
Clinical narrative: received the first dose/on 25-Sep-2020 and has not received dose two.; This case was reported by a other health professional 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 (received 1st dose of Shingrix on 25th September 2020, batch number-EG3A3).   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, the patient did not receive 2nd dose of Shingrix vaccine, which led to incomplete course of vaccination. The reporter consented to follow up.
Age: 57.0
Sex: F
Vaccine: VARZOS
Symptoms: Extra dose administered
Clinical narrative: received three doses of Shingrix; This case was reported by a pharmacist via call center representative and described the occurrence of extra dose administered in a 57-year-old female patient who received Herpes zoster (Shingrix) (batch number 4B53D, expiry date 10th October 2022) for prophylaxis.   Previously administered products included Shingrix (2 doses received on an unknown date).   On 8th June 2021, the patient received the 3rd dose of Shingrix (intramuscular). On 8th June 2021, unknown after receiving Shingrix, the patient experienced extra dose administered. On an unknown date, the outcome of the extra dose administered was unknown.  Additional details were provided are as follows: The patient received three doses of Shingrix which led to extra dose administered. No further information were provided. The reporter consented to follow up.
Age: 68.0
Sex: F
Vaccine: VARZOS
Symptoms: Inappropriate schedule of product administration
Clinical narrative: first dose of Shingrix on 22-Mar-2021 / second dose on 17-May-2021.; This case was reported by a pharmacist via call center representative and described the occurrence of drug dose administration interval too short in a 68-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   Concomitant products included Herpes zoster (Shingrix).   On 17th May 2021, the patient received the 2nd dose of Shingrix (intramuscular). On 17th May 2021, unknown after receiving Shingrix, the patient experienced drug dose administration interval too short. On an unknown date, the outcome of the drug dose administration interval too short was unknown.  Additional details were provided as follows: A pharmacist reported that a patient received the 1st dose of Shingrix on 22th March 2021 and the 2nd dose on 17th May 2021 that was less than recommended time interval and which led to shortening of vaccination schedule. The reporter consented to follow up.
Age: 17.0
Sex: F
Vaccine: HEP
Symptoms: Extra dose administered, Product administered to patient of inappropriate age
Clinical narrative: a 17 year old / received an adult dose of Engerix-B; a 17 year old / received an adult dose of Engerix-B; This case was reported by a nurse via call center representative and described the occurrence of overdose in a 17-year-old female patient who received HBV (Engerix B adult) (batch number N4GA4, expiry date 2nd January 2023) for prophylaxis.   Co-suspect products included hepatitis B vaccine pre-filled syringe device (Engerix B Pre-Filled Syringe Device) injection syringe for prophylaxis.   Previously administered products included Engerix B (1st dose received on an unknown date).   On 8th June 2021, the patient received the 2nd dose of Engerix B adult and Engerix B Pre-Filled Syringe Device. On 8th June 2021, unknown after receiving Engerix B adult and Engerix B Pre-Filled Syringe Device, the patient experienced overdose and inappropriate age at vaccine administration. On an unknown date, the outcome of the overdose and inappropriate age at vaccine administration were 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:  Nurse reported that a 17 year old patient who received an adult dose of Engerix-B, it was administered on the same day as reported it which led to overdose and inappropriate age at vaccine administration. The reporter consented to follow up.
Sex: M
Vaccine: VARZOS
Symptoms: Facial paralysis, Feeling abnormal, Paraesthesia
Clinical narrative: feeling like something moves down with intermittent tingling; falling down feeling on left side of face and cheek bone / like skin is pulling down towards ear; This case was reported by a physician via call center representative and described the occurrence of tingling in a male patient who received Herpes zoster (Shingrix) for prophylaxis.   On 16th March 2021, the patient received the 1st dose of Shingrix. On 16th March 2021, less than a day after receiving Shingrix, the patient experienced tingling and feeling abnormal. On 8th June 2021, the outcome of the tingling and feeling abnormal were recovered/resolved.   It was unknown if the reporter considered the tingling and feeling abnormal to be related to Shingrix.  Additional details were provided are as follows: The age at vaccination was not reported. The patient received 1st dose of Shingrix and on same day experienced falling down feeling on left side of face and cheek bone and feeling like skin is pulling down towards ear or feeling like something moves down with intermittent tingling. No further information were provided. The reporter consented to follow up.
Age: 28.0
Sex: F
Vaccine: COVID19
Symptoms: Erythema, Injection site swelling, Pain, Pruritus, Pyrexia
Clinical narrative: ITCHING; GOLF BALL SIZE SWELLING AT INJECTION SITE ABOUT 6 HOURS AFTER THE VACCINATION; PAIN; ABOUT 3 HOURS  AFTER THE VACCINATION LOW GRADE FEVER  AND TEMPERATURE; REDNESS; This spontaneous report received from a patient concerned a 28 year old female. The patient's height, and weight were not reported. The patient's concurrent conditions included iodine allergy, and other pre-existing medical conditions included no illness or surgery to report. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 1805029 expiry: UNKNOWN) dose was not reported, administered on 12-MAR-2021 12:00 for prophylactic vaccination. Concomitant medications included diphenhydramine hydrochloride for drug used for unknown indication. On 08-MAR-2021, Laboratory data included: COVID-19 virus test negative (NR: not provided) Negative. On 12-MAR-2021, the subject experienced itching. On 12-MAR-2021, the subject experienced golf ball size swelling at injection site about 6 hours after the vaccination. On 12-MAR-2021, the subject experienced pain. On 12-MAR-2021, the subject experienced about 3 hours after the vaccination low grade fever and temperature. On 12-MAR-2021, the subject experienced redness. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient was recovering from itching, and redness, and had not recovered from golf ball size swelling at injection site about 6 hours after the vaccination, pain, and about 3 hours after the vaccination low grade fever and temperature. This report was non-serious.
Age: 28.0
Sex: F
Vaccine: COVID19
Symptoms: SARS-CoV-2 test negative
Clinical narrative: ITCHING; GOLF BALL SIZE SWELLING AT INJECTION SITE ABOUT 6 HOURS AFTER THE VACCINATION; PAIN; ABOUT 3 HOURS  AFTER THE VACCINATION LOW GRADE FEVER  AND TEMPERATURE; REDNESS; This spontaneous report received from a patient concerned a 28 year old female. The patient's height, and weight were not reported. The patient's concurrent conditions included iodine allergy, and other pre-existing medical conditions included no illness or surgery to report. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 1805029 expiry: UNKNOWN) dose was not reported, administered on 12-MAR-2021 12:00 for prophylactic vaccination. Concomitant medications included diphenhydramine hydrochloride for drug used for unknown indication. On 08-MAR-2021, Laboratory data included: COVID-19 virus test negative (NR: not provided) Negative. On 12-MAR-2021, the subject experienced itching. On 12-MAR-2021, the subject experienced golf ball size swelling at injection site about 6 hours after the vaccination. On 12-MAR-2021, the subject experienced pain. On 12-MAR-2021, the subject experienced about 3 hours after the vaccination low grade fever and temperature. On 12-MAR-2021, the subject experienced redness. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient was recovering from itching, and redness, and had not recovered from golf ball size swelling at injection site about 6 hours after the vaccination, pain, and about 3 hours after the vaccination low grade fever and temperature. This report was non-serious.
Sex: U
Vaccine: COVID19
Symptoms: Chills, Fatigue, Pyrexia
Clinical narrative: CHILLS; FEVER; EXHAUSTION; This spontaneous report received from a patient . The patient's weight, height, and medical history were not reported .The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: unknown expiry date: unknown) dose, start therapy date were not reported for prophylactic vaccination. The batch number was not reported and has been requested. No concomitant medications were reported. On an unspecified date, the subject experienced chills, fever, and exhaustion. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the fever, chills and exhaustion was not reported. This report was non-serious.
Sex: F
Vaccine: COVID19
Symptoms: Arthralgia, Malaise, Nodule, Pyrexia, Respiratory tract congestion
Clinical narrative: CHEST CONGESTION; FELT SOMETHING BAD IN HER HIP KNOTS UNDER HER SKIN; NOT FEELING WELL; FEVER AND CHILLS; JOINT PAIN; This spontaneous report received from a patient concerned a female of unspecified age. The patient's weight, height, and medical history were not reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported) dose was not reported, administered on 12-MAR-2021 for prophylactic vaccination. The batch number was not reported. The Company is unable to perform follow-up to request batch/lot numbers. No concomitant medications were reported. On an unspecified date, the subject experienced chest congestion, felt something bad in her hip knots under her skin, not feeling well, fever and chills, and joint pain. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the joint pain, chest congestion, felt something bad in her hip knots under her skin, not feeling well and fever and chills was not reported. This report was non-serious.
Sex: M
Vaccine: COVID19
Symptoms: Poor quality product administered, Product storage error
Clinical narrative: VACCINE KEPT IN THE FREEZER THAWED OVERNIGHT AND KEPT IN THE FRIDGE TILL VACCINATION; POOR QUALITY DRUG ADMINISTERED; This spontaneous report received from a pharmacist concerned a 61 year old male. 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, and batch number: 1821288 expiry: UNKNOWN) dose was not reported, administered on 01-JUN-2021 for prophylactic vaccination. No concomitant medications were reported. On 01-JUN-2021, the subject experienced the vaccine kept in the freezer thawed overnight and kept in the fridge till vaccination. On 01-JUN-2021, the subject experienced poor quality drug administered. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the vaccine kept in the freezer thawed overnight and kept in the fridge till vaccination and poor quality drug administered was not reported. This report was non-serious. This case, from the same reporter is linked to 20210605104, 20210605120 and 20210605009.
Age: 60.0
Sex: F
Vaccine: COVID19
Symptoms: Abdominal pain, Arthralgia, Chills, Headache
Clinical narrative: ABDOMINAL CRAMPING; EXTREME CHILLS; SHOULDER PAIN IN BOTH SHOULDERS; REALLY BAD HEADACHE; This spontaneous report received from a patient concerned a 60 year old female. 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, and batch number: 042A21A expiry: UNKNOWN) dose was not reported, administered on 02-JUN-2021 for prophylactic vaccination. No concomitant medications were reported. On 02-JUN-2021, the subject experienced abdominal cramping. On 02-JUN-2021, the subject experienced extreme chills. On 02-JUN-2021, the subject experienced shoulder pain in both shoulders. On 02-JUN-2021, the subject experienced really bad headache. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from abdominal cramping, and had not recovered from extreme chills, really bad headache, and shoulder pain in both shoulders. This report was non-serious.
Sex: U
Vaccine: COVID19
Symptoms: Adverse event
Clinical narrative: UNSPECIFIED ADVERSE EVENT; This spontaneous report received from a patient concerned a patient of unspecified age and sex. 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) dose was not reported, administered on 07-APR-2021 for prophylactic vaccination. The batch number was not reported. The Company is unable to perform follow-up to request batch/lot numbers. Concomitant medications included omalizumab. On an unspecified date, the subject experienced unspecified adverse event. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of unspecified adverse event was not reported. This report was non-serious.