chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Sex: F
Vaccine: VARCEL
Symptoms: Antibody test, Blood test, CSF test abnormal, Magnetic resonance imaging, Neuromyelitis optica spectrum disorder
Clinical narrative: neuromyelitis and paralysis / her "spinal fluid looked white"; the virus attacked her spine; Caller confirmed that she did not receive a dose of the vaccine, but caller administered the vaccine to a patient and "maybe did not wash hands good enough,"; Caller confirmed that she did not receive a dose of the vaccine, but caller administered the vaccine to a patient and "maybe did not wash hands good enough,"; This spontaneous report was received from a 66 years old female patient, who was referring to herself. The patient's concurrent conditions included high blood pressure, sjogren's syndrome and several unspecified allergies. Her concomitant medications included unspecified blood pressure medicine.  On an unknown date in January 2012, the reporter was administering to an unknown patient the dose of varicella virus vaccine live (oka/merck) (VARIVAX) for prophylaxis (dose, frequency, route of administration, lot# and expiration date were not reported). The reporter confirmed that she did not receive a dose of the vaccine, but "maybe did not wash hands good enough". On an unknown date in January 2012, she experienced neuromyelitis and paralysis, her "spinal fluid looked white" and the virus attacked her spine. The patient was hospitalized due to the events in February 2012 for approximately one week and again in September 2012 for approximately 10 days. On an unknown date, unspecified blood work, antibodies testing and magnetic resonance imaging (MRI) of spine were performed but no results were provided. She received plasmapheresis and physical therapy as a treatment. The outcome of the events was reported as mostly recovered/resolved on an unknown date in March 2013. The causality assessment between the events and the suspect therapy was not provided.  Upon internal review, the events of neuromyelitis and paralysis, her "spinal fluid looked white" and the virus attacked her spine were determined to be medically significant.
Sex: F
Vaccine: VARCEL
Symptoms: Paralysis, Plasmapheresis, Viral myelitis
Clinical narrative: neuromyelitis and paralysis / her "spinal fluid looked white"; the virus attacked her spine; Caller confirmed that she did not receive a dose of the vaccine, but caller administered the vaccine to a patient and "maybe did not wash hands good enough,"; Caller confirmed that she did not receive a dose of the vaccine, but caller administered the vaccine to a patient and "maybe did not wash hands good enough,"; This spontaneous report was received from a 66 years old female patient, who was referring to herself. The patient's concurrent conditions included high blood pressure, sjogren's syndrome and several unspecified allergies. Her concomitant medications included unspecified blood pressure medicine.  On an unknown date in January 2012, the reporter was administering to an unknown patient the dose of varicella virus vaccine live (oka/merck) (VARIVAX) for prophylaxis (dose, frequency, route of administration, lot# and expiration date were not reported). The reporter confirmed that she did not receive a dose of the vaccine, but "maybe did not wash hands good enough". On an unknown date in January 2012, she experienced neuromyelitis and paralysis, her "spinal fluid looked white" and the virus attacked her spine. The patient was hospitalized due to the events in February 2012 for approximately one week and again in September 2012 for approximately 10 days. On an unknown date, unspecified blood work, antibodies testing and magnetic resonance imaging (MRI) of spine were performed but no results were provided. She received plasmapheresis and physical therapy as a treatment. The outcome of the events was reported as mostly recovered/resolved on an unknown date in March 2013. The causality assessment between the events and the suspect therapy was not provided.  Upon internal review, the events of neuromyelitis and paralysis, her "spinal fluid looked white" and the virus attacked her spine were determined to be medically significant.
Sex: U
Vaccine: HPV9
Symptoms: Product storage error
Clinical narrative: No additional AE's noted; improperly stored GARDASIL 9 administered to the patient; This spontaneous report as received from a registered nurse refers to a patient of unknown age and gender. Information on the patient's concurrent conditions, medical history or concomitant therapy was not reported.      On 31-MAR-2021, the patient was vaccinated with improperly stored hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast) (GARDASIL 9) (lot # 1637648, expiration date: 19-JUN-2022, dose/frequency: 1, route of administration and anatomical location were not reported). The vaccine was stored in -0.1 degrees Celsius for 4 hours and 11.5 degrees Celsius for 11 hours and 30 min. Digital data logger was involved. No additional adverse events (AE's) noted. Patient was asymptomatic. combinationproductreport: Yes; brandname: GARDASIL 9 SYRINGE (DEVICE); commondevicename: HPV rL1 6 11 16 18 31 33 45 52 58 VLP vaccine (yeast); productcode: FMF; manufacturername: Merck Sharp & Dohme Corp. ; devicelotnumber: 1637648; expirationdate: 19-JUN-2022; deviceage and unit: 0 ; malfunction: Unknown; deviceusage: Initial; reasonfornoneval: 81 Other; labeledsingleusedevice: No; mdcpreportability: No; mdcpreprationale: Case information does not meet the criteria for Reportability
Sex: U
Vaccine: VARZOS
Symptoms: Autoimmune haemolytic anaemia, Bell's palsy, Chromaturia, Dizziness, Facial paralysis
Clinical narrative: Autoimmune Hemolytic Anemia; Bell's Palsy; Information has been received from a lawyer concerning a case in litigation and refers to a patient of unknown age and gender. In or around October 29, 2012, patient was inoculated with zoster vaccine live (ZOSTAVAX) (dose, 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), patient suffered severe symptoms of fatigue, dizziness, jaundice, and a syncope episode he also had very dark urine and was diagnosed with sudden onset of autoimmune hemolytic anemia. Patient additionally suffered right side facial paralysis and was diagnosed with Bell's Palsy. As a direct and proximate result of zoster vaccine live (ZOSTAVAX) vaccine, patient's symptoms have resulted in physical limitations not present prior to using the product. Patient also experiences 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), patient sustained severe and permanent personal injuries. Further, as a tragic consequence of company's wrongful conduct, patient 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 company's conduct, patient has suffered and incurred damages, including medical expenses; the loss of accumulations; and other economic and non-economic damages. The outcome of the events was unknown. The events were considered to be related to zoster vaccine live (ZOSTAVAX).     Upon internal review, the events of autoimmune hemolytic anemia and Bell's Palsy were considered to be medically significant.
Sex: U
Vaccine: VARZOS
Symptoms: Fatigue, Jaundice, Syncope
Clinical narrative: Autoimmune Hemolytic Anemia; Bell's Palsy; Information has been received from a lawyer concerning a case in litigation and refers to a patient of unknown age and gender. In or around October 29, 2012, patient was inoculated with zoster vaccine live (ZOSTAVAX) (dose, 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), patient suffered severe symptoms of fatigue, dizziness, jaundice, and a syncope episode he also had very dark urine and was diagnosed with sudden onset of autoimmune hemolytic anemia. Patient additionally suffered right side facial paralysis and was diagnosed with Bell's Palsy. As a direct and proximate result of zoster vaccine live (ZOSTAVAX) vaccine, patient's symptoms have resulted in physical limitations not present prior to using the product. Patient also experiences 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), patient sustained severe and permanent personal injuries. Further, as a tragic consequence of company's wrongful conduct, patient 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 company's conduct, patient has suffered and incurred damages, including medical expenses; the loss of accumulations; and other economic and non-economic damages. The outcome of the events was unknown. The events were considered to be related to zoster vaccine live (ZOSTAVAX).     Upon internal review, the events of autoimmune hemolytic anemia and Bell's Palsy were considered to be medically significant.
Age: 60.0
Sex: U
Vaccine: VARZOS
Symptoms: Colitis ulcerative
Clinical narrative: ulcerative colitis; Information has been received from a lawyer regarding a case in litigation and refers to a patient of unknown age and gender. The patient's medical history and concomitant therapy were not reported. On or about 24-MAY-2016, the patient was vaccinated with zoster vaccine live(ZOSTAVAX) (dose, route of adminstration, lot # and expiration date were not reported) for the long-term prevention of shingles and zoster-related conditions in a private physician's office. Subsequently, the patient was treated for the following injuries resulting from zoster vaccine live (ZOSTAVAX) use: ulcerative colitis. The outcome of ulcerative colitis was unknown. The event of ulcerative colitis was considered to be related to zoster vaccine live (ZOSTAVAX).  Upon internal review, the event of ulcerative colitis was determined to be medically significant.
Sex: U
Vaccine: MMRV
Symptoms: Product storage error
Clinical narrative: No other AE/PQC reported; temperature excursion; This spontaneous report was received from a vaccine coordinator and refers to a patient of unknown age and gender. No information regarding the patient's medical history, concurrent conditions, concomitant medications and previous drug reactions or allergies was reported.  On 15-MAR-2021, the patient was vaccinated with improperly stored dose of measles, mumps, rubella and varicella (oka-merck) virus vaccine live (rHA) (PROQUAD), for prophylaxis, lot # T013537 was verified to be valid, expiration date reported and established as 17-OCT-2021, (dose, frequency, route of administration and vaccination site were not provided).  The administered dose of vaccine experienced a temperature excursion of -6.7 Celsius degrees for 2 hours. There were no previous temperature excursions. The patient did not experience any additional adverse reactions. Digital Data logger was involved. The outcome, action taken and causality assessment were not provided.
Sex: M
Vaccine: HPV9
Symptoms: Drug effective for unapproved indication
Clinical narrative: NY Urologist treated a 60 year old male who was positive for HPV type 6 and 11 genital warts with the GARDASIL 9 vaccine; the patient had no additional transmission or progression, as well as reported remission of HPV; This spontaneous report was received from a physician assistant and refers to a 60-year-old male patient. There was no information about the patients, medical history, drug reactions or allergies and concomitant therapies provided. His concurrent conditions included Human Papilloma virus (HPV) 6 and 11 (unspecified) and genital warts.  On an unknown date, the patient current condition of HPV was treated with hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast) (GARDASIL 9) (strength, dose, route of administration, anatomical location, frequency, lot number and expiration date were not reported) (Off label use in unapproved indication).  The reporter stated that, according to the article he read, the patient had no additional transmission or progression, as well as reported remission of HPV (drug effective for unapproved indication).
Age: 1.25
Sex: U
Vaccine: HIBV
Symptoms: Expired product administered
Clinical narrative: The patient did not experience any other AEs; received an expired dose of PEDV AX HIB on 4/2/2021; This spontaneous report was received from a medical assistant who was reporting on 15-month-old patient of unknown gender. There was no information about the patients concurrent conditions, medical history, drug reactions or allergies and concomitant therapies provided.  On 02-APR-2021, the patient was vaccinated with expired dose of haemophilus b conjugate vaccine (meningococcal protein conjugate) (LIQUID PEDVAXHIB) 1 dose (exact dose, route of administration, anatomical location and strength were not provided; lot number was reported as s030207 and confirmed to be not valid; expiration date was reported as 25-MAR-2021) for prophylaxis (expired product administered).  The patient did not experienced any other adverse events.
Sex: U
Vaccine: MMRV
Symptoms: Product storage error
Clinical narrative: Caller notes patient is asymptomatic. No additional AE's reported.; Caller reported a temperature excursion which was administered to a patient on 3/22/2021.; This spontaneous report was received from a nurse and refers to an identifiable patient of unknown age and gender. No information regarding the patient's pertinent medical history, drug reactions, allergies, or concomitant therapies was provided.  On 22-MAR-2021, the patient was vaccinated with measles, mumps, rubella and varicella (oka-merck) virus vaccine live (PROQUAD), dose reported as 1, lot # T025505, expiration date 23-JAN-2022 (route of administration was not provided) for prophylaxis. The patient was asymptomatic. No adverse event was reported. Administered dose of vaccine experienced the temperature excursion of 18 Fahrenheit degrees for 11 hours and 40 minutes. The digital data logger was involved in recording the temperature excursion details. There were no previous excursions reported.
Sex: F
Vaccine: PPV
Symptoms: Erythema nodosum, Pyrexia, Vaccination complication
Clinical narrative: erythema nodosum; prolonged high fever; serious adverse reaction to the vaccine;   This spontaneous report has been received from a consumer, concerning a currently 45-year old female patient reporting on herself. The patient's concurrent conditions included Behcet's syndrome, Ehlers-danlos syndrome, migraine, coeliac disease and asthma. The patient's concomitant medications were not provided.  On unspecified date, the patient revived a dose of Pneumococcal Vaccine, Polyvalent (23-valent) (PNEUMOVAX), (dosage information not provided) for prophylaxis.  After the vaccination, it was reported that the patient experienced a serious adverse reaction to the vaccine including prolonged high fever and erythema nodosum. At the time of the report, the patient's outcome was unknown. The reporter considered the events to be related to Pneumococcal Vaccine, Polyvalent (23-valent) (PNEUMOVAX).  The events of pyrexia, erythema nodosum and vaccination complication were considered medically significant by the reporter.
Sex: U
Vaccine: VARZOS
Symptoms: Herpes zoster, Illness, Stress, Vaccination failure
Clinical narrative: Since I've had my shot for shingles many years ago, I've only had a few mind cases/Suspected vaccination failure; Since I've had my shot for shingles many years ago I've only had a few mind cases; stress; illness; This case was reported by a consumer via Shingles interactive digital media and described the occurrence of Suspected vaccination failure in a patient who received Herpes zoster (Shingles vaccine).   On an unknown date, the patient received Shingle's vaccine. On an unknown date, unknown after receiving Shingle's vaccine, the patient experienced vaccination failure (serious criteria GSK medically significant), shingles, stress and illness. On an unknown date, the outcome of the vaccination failure, shingles, stress and illness were unknown.   It was unknown if the reporter considered the vaccination failure, shingles, stress and illness to be related to Shingle's vaccine.  Additional details were provided as follows: The age at vaccination was not reported. The patient had Shingles shot many years ago and had few mild cases and it was from stress or illness. This case was considered as suspected vaccination failure as details regarding completion of primary vaccination schedule, laboratory confirmation and time to onset of shingles were unknown at the time of reporting.  Note: It was reported that the patient had few mind cases, but it seems to be typo error and thus it was considered as mild case. Hence by considering worst case approach shingles was captured as event and also stress and illness captured as event conservatively.
Sex: U
Vaccine: VARZOS
Symptoms: Headache, Pain
Clinical narrative: headache; body ache; This case was reported by a consumer via call center representative and described the occurrence of headache in a adult patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   On 7th April 2021, the patient received the 2nd dose of Shingles vaccine. In April 2021, less than a week after receiving Shingles vaccine, the patient experienced headache and general body pain. On an unknown date, the outcome of the headache and general body pain were not recovered/not resolved.   It was unknown if the reporter considered the headache and general body pain to be related to Shingles vaccine.  Additional details were provided as follows: The patient had reported the case for himself/herself. The age group was not reported but was captured as an adult as per vaccine indication.  The patient received 2nd shot and asked if he/she could take Aspirin or Tylenol for his/her headache and body ache and was it ok. The patient mentioned that, he/she would call his/her doctor as his/her symptoms were mild. The follow-up would not possible, as no contact details were available.
Age: 61.0
Sex: U
Vaccine: VARZOS
Symptoms: Dry skin, Pruritus, Rash erythematous
Clinical narrative: Woke up with Itching on my back / Am I contracting Chickenpox or Shingles?; Woke up with / red spots/dry / on my back / Am I contracting Chickenpox or Shingles?; Woke up with / red spots/dry / on my back; This case was reported by a other health professional via call center representative and described the occurrence of pruritus in a 61-year-old patient who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included Shingrix with an associated reaction of no adverse event (received 1st dose on unknown date, refer case US2021AMR079010).   On 6th April 2021, the patient received the 2nd dose of Shingrix. On 8th April 2021, 2 days after receiving Shingrix, the patient experienced pruritus, red rash and dry skin. On an unknown date, the outcome of the pruritus, red rash and dry skin were unknown.   It was unknown if the reporter considered the pruritus, red rash and dry skin to be related to Shingrix.  Additional details were provided as follows: The patient was a healthcare worker and reported for himself/herself. The patient stated that this morning he/she woke up with Itching on back with red spots/dry. The patient was asking if it was contracting Chickenpox or Shingles. The patient stated that he/she just had routine side effects until this.; Sender's Comments:  US-GLAXOSMITHKLINE-US2021AMR079010:Same reporter.
Sex: M
Vaccine: VARZOS
Symptoms: Joint swelling, Pain, Peripheral swelling, Walking aid user
Clinical narrative: Severe pain / needed to use crutches; joints, feet, elbows and knees swelling; feet / swelling; Severe pain / needed to use crutches; This case was reported by a consumer via other manufacturer and described the occurrence of pain in a male patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   On an unknown date, the patient received the 2nd dose of Shingles vaccine. On an unknown date, 4 hrs after receiving Shingles vaccine, the patient experienced pain, swollen joints, swelling of feet and crutch user. On an unknown date, the outcome of the pain, swollen joints, swelling of feet and crutch user were unknown.   It was unknown if the reporter considered the pain, swollen joints, swelling of feet and crutch user to be related to Shingles vaccine.  Additional details were provided as follows: This case was reported by patient himself. The age at vaccination was not reported. The patient reported of having a reaction in the past to the 2nd dose of Shingles vaccine. The patient experienced joints, feet, elbows and knee swelling and was in severe pain and needed to use crutches. The reporter's and healthcare professional s consent to follow-up was reported as not applicable.
Sex: F
Vaccine: VARZOS
Symptoms: Blister, Rash macular
Clinical narrative: Pox; Pox; This case was reported by a pharmacist via sales rep and described the occurrence of red spotty rash in a adult female patient who received Herpes zoster (Shingrix) for prophylaxis.   On an unknown date, the patient received the 1st dose of Shingrix (intramuscular). On an unknown date, unknown after receiving Shingrix, the patient experienced red spotty rash and blister. On an unknown date, the outcome of the red spotty rash and blister were unknown.   It was unknown if the reporter considered the red spotty rash and blister to be related to Shingrix.  Additional details were provided as follows: The age at vaccination was not reported. The pharmacist reported that she received 1st dose of Shingrix and experienced pox. No other information was available. The reporter did not consented to follow up.
Sex: F
Vaccine: VARZOS, VARZOS
Symptoms: Joint swelling, Off label use, Peripheral swelling, Product administered at inappropriate site, Rash erythematous
Clinical narrative: second vaccine, she chose to have it in her buttocks; Off label use; Welts; Red Streaks; Swelling on her injection site arm from her left shoulder to her left fingertips; Swelling on her injection site arm from her left shoulder; This case was reported by a other health professional via sales rep and described the occurrence of welts in a adult female 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 (intramuscular) and the 2nd dose of Shingrix. On an unknown date, unknown after receiving Shingrix and not applicable after receiving Shingrix, the patient experienced welts, red rash, swelling arm, swollen joints, vaccine administered at inappropriate site and off label use. On an unknown date, the outcome of the welts, red rash, swelling arm and swollen joints were recovered/resolved and the outcome of the vaccine administered at inappropriate site and off label use were unknown.   It was unknown if the reporter considered the welts, red rash, swelling arm and swollen joints to be related to Shingrix.  Additional details were provided as follows: The patient was an office manager and was vaccine representative. The age at vaccination was not reported. The patient experienced welts, red streaks and swelling on her injection site arm from her left shoulder to her left fingertips. These symptoms were from her first vaccine and lasted seven days. To avoid having the same reaction from her second vaccine, the patient chose to have it in her buttocks, which led vaccine administered at inappropriate site and off label use. The reporter did not consent to follow-up.
Sex: F
Vaccine: VARZOS, VARZOS
Symptoms: Urticaria
Clinical narrative: second vaccine, she chose to have it in her buttocks; Off label use; Welts; Red Streaks; Swelling on her injection site arm from her left shoulder to her left fingertips; Swelling on her injection site arm from her left shoulder; This case was reported by a other health professional via sales rep and described the occurrence of welts in a adult female 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 (intramuscular) and the 2nd dose of Shingrix. On an unknown date, unknown after receiving Shingrix and not applicable after receiving Shingrix, the patient experienced welts, red rash, swelling arm, swollen joints, vaccine administered at inappropriate site and off label use. On an unknown date, the outcome of the welts, red rash, swelling arm and swollen joints were recovered/resolved and the outcome of the vaccine administered at inappropriate site and off label use were unknown.   It was unknown if the reporter considered the welts, red rash, swelling arm and swollen joints to be related to Shingrix.  Additional details were provided as follows: The patient was an office manager and was vaccine representative. The age at vaccination was not reported. The patient experienced welts, red streaks and swelling on her injection site arm from her left shoulder to her left fingertips. These symptoms were from her first vaccine and lasted seven days. To avoid having the same reaction from her second vaccine, the patient chose to have it in her buttocks, which led vaccine administered at inappropriate site and off label use. The reporter did not consent to follow-up.
Sex: M
Vaccine: VARZOS
Symptoms: Tinnitus
Clinical narrative: experienced tinnitus after receiving the Shingrix vaccine; This case was reported by a consumer via call center representative and described the occurrence of tinnitus in a male patient who received Herpes zoster (Shingrix) for prophylaxis.   On an unknown date, the patient received Shingrix. On an unknown date, unknown after receiving Shingrix, the patient experienced tinnitus. On an unknown date, the outcome of the tinnitus was unknown.   It was unknown if the reporter considered the tinnitus to be related to Shingrix.  Additional details were provided as follows: The case was reported by reporter for her son-in-law. The age at vaccination was not reported. The patient received a dose of shingrix and experienced tinnitus. No other information was reported. The reporter did not consent to follow-up.
Sex: M
Vaccine: HEP
Symptoms: Inappropriate schedule of product administration
Clinical narrative: today HCP is going to vaccinated him with an adult second dose / give Engerix-B adult dose to a 19 year-old male patient today ( April 7th 2021); This case was reported by a other health professional via call center representative and described the occurrence of incomplete course of vaccination in a 19-year-old male patient who received HBV (Engerix B adult) for prophylaxis.   Previously administered products included Engerix B adult (received 1st dose on 13th August 2019).   On an unknown date, the patient received the 2nd dose of Engerix B adult. On an unknown date, unknown after receiving Engerix B adult, 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 physician assistant was looking for information if she could use Engerix B adult dose to the patient.  The patient received his 1st dose 19 months ago and till the time of reporting he did not receive any further doses, which led to incomplete course of vaccination. On the day of reporting, the healthcare professional was going to vaccinated him with the 2nd dose of Engerix B adult. The reporter consented to follow up and requested to follow-up by email.
Age: 4.0
Sex: M
Vaccine: DTAPIPV
Symptoms: Expired product administered
Clinical narrative: given a dose of Kinrix that had expired; This case was reported by a nurse via call center representative and described the occurrence of expired vaccine used in a 4-year-old male patient who received DTPa-IPV (Kinrix) (batch number 394C2, expiry date 18th January 2021) for prophylaxis.   Co-suspect products included dtpa-ipv vaccine pre-filled syringe device (Kinrix Pre-Filled Syringe Device) injection syringe for prophylaxis.   On 5th March 2021, the patient received Kinrix and Kinrix Pre-Filled Syringe Device. On 5th March 2021, unknown after receiving Kinrix and Kinrix 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 reporter stated that, 4 years old patient received already expired Kinrix vaccine,which led to expired vaccine used. The reporter consented to follow up.
Sex: M
Vaccine: HEP
Symptoms: Expired product administered
Clinical narrative: Engerix B pediatric dose to a patient that had expired yesterday; This case was reported by a other health professional via call center representative and described the occurrence of expired vaccine used in a 19-year-old male patient who received HBV (Engerix B pediatric) (batch number 3JD32, expiry date 6th April 2021) for prophylaxis.   Co-suspect products included hepatitis B vaccine pre-filled syringe device (Engerix B Pre-Filled Syringe Device) injection syringe for prophylaxis.   On an unknown date, the patient received Engerix B pediatric (intramuscular) and Engerix B Pre-Filled Syringe Device. On an unknown date, unknown after receiving Engerix B pediatric and Engerix B 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 age at vaccination was not reported. The reporter identified herself as clinical supervisor and reported that Engerix B pediatric dose to the patient that had expired a day before reporting date, which led to expired vaccine used.
Sex: U
Vaccine: VARZOS
Symptoms: Incomplete course of vaccination
Clinical narrative: patient is late for the second dose / The first dose was administrated on January 2020; This case was reported by a pharmacist via call center representative and described the occurrence of incomplete course of vaccination in a adult patient who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included Shingrix (received 1st dose of Shingrix on January 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 was reported as follows: The age at vaccination was not applicable to this report. The age group was not reported but captured adult as per vaccine indication. Till the reporting patient did not received the 2nd dose, which led to incomplete course of vaccination. No patient's identifiers provided no lot number nor expiration date provided no vaccination date provided. The reporter consented to follow up.
Sex: F
Vaccine: VARZOS
Symptoms: Product administered at inappropriate site
Clinical narrative: received one dose of Shingrix / intramuscularly in the gluteal area; This case was reported by a nurse via call center representative and described the occurrence of vaccine administered at inappropriate site in a female patient who received Herpes zoster (Shingrix) for prophylaxis.   In October 2020, the patient received the 1st dose of Shingrix (intramuscular). In October 2020, unknown after receiving Shingrix, the patient experienced vaccine administered at inappropriate site. On an unknown date, the outcome of the vaccine administered at inappropriate site was unknown.  Additional details were provided as follows: The age at the vaccination was not reported. The patient received 1st dose of Shingrix in the gluteal area, which led to vaccine administered at inappropriate site. No adverse event was reported. The reporter did not consent to follow up.
Sex: U
Vaccine: VARZOS
Symptoms: Incomplete course of vaccination
Clinical narrative: first dose was administrated 800 days ago; This case was reported by a pharmacist via call center representative and described the occurrence of incomplete course of vaccination in a adult patient who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included Shingrix (received 1st dose 800 days before day of reporting).   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 age group was not reported but it was selected as adult as per the vaccine indication. No patient's identifiers were provided. No lot number nor expiration date were provided. No vaccination date was provided. The patient was late for the second dose of Shingrix, which led to incomplete course of vaccination. No adverse event was reported. The reporter did not consent to follow up.
Sex: F
Vaccine: VARZOS
Symptoms: Incomplete course of vaccination
Clinical narrative: received 1st dose in January 2020 / not received 2nd dose yet; This case was reported by a consumer via call center representative and described the occurrence of incomplete course of vaccination in a adult female patient who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included Shingrix (received 1st dose in January 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 provided as follows: The age at vaccination was not applicable. The age group was not reported but was selected as an adult as per vaccine indication.  The patient did not receive 2nd dose, which led to incomplete course of vaccination. The reporter did not consent to follow up.
Sex: M
Vaccine: VARZOS
Symptoms: Incomplete course of vaccination
Clinical narrative: Not certain if / shingrix or zostavax / First dose / 3 years ago and wants to continue on with shingrix; This case was reported by a pharmacist via call center representative and described the occurrence of incomplete course of vaccination in a 74-year-old male patient who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included Shingrix (1st dose received on an unknown date 3 years ago).   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 a pharmacist on behalf of patient. 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 pharmacist inquired about receiving Shingrix after Zostavax, but the patient was not certain if he received Shingrix or Zostavax 3 years ago. The pharmacist stated that the patient received 1st dose of a zoster vaccine 3 years ago and wanted to continue with Shingrix at this time. The reporter did not consent to follow-up. Note: The case was conservatively kept valid with Shingrix as suspect, as it was not clear that the patient had received 1st dose of Shingrix or Zostavax.
Age: 52.0
Sex: M
Vaccine: VARZOS
Symptoms: COVID-19
Clinical narrative: COVID-19 / received monoclonal antibodies after first dose of shingrix; This case was reported by a other health professional via call center representative and described the occurrence of covid-19 in a 52-year-old male patient who received Herpes zoster (Shingrix) for prophylaxis.   On 2nd November 2020, the patient received the 1st dose of Shingrix. On an unknown date, less than 4 months after receiving Shingrix, the patient experienced covid-19. The patient was treated with monoclonal antibody (nos) (Monoclonal Antibody), casirivimab and imdevimab. On an unknown date, the outcome of the covid-19 was unknown.   It was unknown if the reporter considered the covid-19 to be related to Shingrix.  Additional details were provided as follows: The case was reported by pharmacist students. The age at vaccination was not reported. The patient had received first dose of shingrix and developed COVID-19. The patient experienced COVID 19 infection and received monoclonal antibodies, casirivimab and imdevimab for COVID-19 infection on 10th February 2021 as a treatment. No other information was reported.
Age: 30.0
Sex: F
Vaccine: COVID19
Symptoms: Fatigue, Headache, Nausea, Pain, Pyrexia
Clinical narrative: FULL BODY HIVES; HEADACHE; EXTREME FATIGUE; NAUSEA; FEVER; BODYACHE; This spontaneous report received from a patient concerned a 30 year old female. The patient's weight was 110 (unit unspecified), and height was 5.1 (unit unspecified). The patient's concurrent conditions included asthma, and other pre-existing medical conditions included unknown. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, intramuscular, batch number: 1805022, and batch number: 1805022 expiry: 25-MAY-2021) dose was not reported, administered on 06-MAR-2021 10:30 to Left Arm for prophylactic vaccination. No concomitant medications were reported. On 06-MAR-2021, the subject experienced bodyache. On 06-MAR-2021, the subject experienced headache. On 06-MAR-2021, the subject experienced extreme fatigue. On 06-MAR-2021, the subject experienced nausea. On 06-MAR-2021, the subject experienced fever. On 10-MAR-2021, the subject experienced full body hives. Treatment medications (dates unspecified) included: diphenhydramine hydrochloride. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from bodyache, extreme fatigue, nausea, and fever on MAR-2021, recovered with sequelae from headache on MAR-2021, and was recovering from full body hives. This report was non-serious.
Age: 30.0
Sex: F
Vaccine: COVID19
Symptoms: Urticaria
Clinical narrative: FULL BODY HIVES; HEADACHE; EXTREME FATIGUE; NAUSEA; FEVER; BODYACHE; This spontaneous report received from a patient concerned a 30 year old female. The patient's weight was 110 (unit unspecified), and height was 5.1 (unit unspecified). The patient's concurrent conditions included asthma, and other pre-existing medical conditions included unknown. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, intramuscular, batch number: 1805022, and batch number: 1805022 expiry: 25-MAY-2021) dose was not reported, administered on 06-MAR-2021 10:30 to Left Arm for prophylactic vaccination. No concomitant medications were reported. On 06-MAR-2021, the subject experienced bodyache. On 06-MAR-2021, the subject experienced headache. On 06-MAR-2021, the subject experienced extreme fatigue. On 06-MAR-2021, the subject experienced nausea. On 06-MAR-2021, the subject experienced fever. On 10-MAR-2021, the subject experienced full body hives. Treatment medications (dates unspecified) included: diphenhydramine hydrochloride. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from bodyache, extreme fatigue, nausea, and fever on MAR-2021, recovered with sequelae from headache on MAR-2021, and was recovering from full body hives. This report was non-serious.
Sex: F
Vaccine: COVID19
Symptoms: Myocardial infarction
Clinical narrative: HEART ATTACK SYMPTOMS; This spontaneous report received from a consumer 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, batch number: Unknown) dose, 1 total, start therapy date were not reported for prophylactic vaccination. Batch number was not reported. Per procedure, no follow up will be requested for this case. No concomitant medications were reported. The patient got the J&J shot Wednesday and on Thursday afternoon, she was admitted to hospital with heart attack symptoms. They kept her overnight, done all test they could on her heart and it all came back good. Doctor said it was reaction to her shot. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of heart attack symptoms was not reported. The reporter considered the causality between covid-19 vaccine ad26.cov2.s and heart attack symptoms as related. Company causality between covid-19 vaccine ad26.cov2.s and heart attack symptoms was possible. This report was serious (Hospitalization Caused / Prolonged).; Sender's Comments: V0:20210329765-Covid-19 vaccine ad26.cov2.s-Heart Attack Symptoms. This event is considered unassessable. The event 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.
Sex: F
Vaccine: COVID19
Symptoms: Body temperature, Heart rate, Heart rate increased, Influenza like illness, Palpitations
Clinical narrative: FLU LIKE SYMPTOMS; TINGLING IN LIPS; TOUNGE FELT THICK/HEAVY; ELEVATED HEART RATE; HEART BEGAN RACING (CONSISTENT95-100 BPM); This spontaneous report received from a patient concerned a 24 year old female. The patient's height, and weight were not reported. The patient's past medical history included covid, breast cancer, skin cancer, and clot, and concurrent conditions included seafood allergy, erythromycin allergy, sulfa allergy, high cholesterol, thyroid, glucose intolerance, non-smoker, and non-alcoholic, and other pre-existing medical conditions included the patient has no history of drug abuse. patient height was 5'7 and weight was 220. patient did not have illness at the time of vaccination, has past history of similar events, did not have any adverse event after any previous vaccination, did not have any pre-existing acute illness 30 days prior to vaccination, no history of hospitalization in last 30 days with cause, no any family disease history, patient was not pregnant at the time of vaccination, and not breastfeeding at the time of reporting. The patient was previously treated with semaglutide for clot, and levothyroxine sodium. 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 13-MAR-2021 for prophylactic vaccination. Concomitant medications included paracetamol for cholesterol, atorvastatin for glucose intolerance, levothyroxine for thyroid disorder, and rivaroxaban for thyroid disorder. On 13-MAR-2021, the subject experienced tingling in lips. On 13-MAR-2021, the subject experienced tounge felt thick/heavy. On 13-MAR-2021, the subject experienced elevated heart rate. On 13-MAR-2021, the subject experienced heart began racing (consistent95-100 bpm). Laboratory data included: Heart rate (NR: not provided) 95-100 BPM. On 14-MAR-2021, the subject experienced flu like symptoms. Laboratory data included: Body temperature (NR: not provided) 100.1 F. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from tingling in lips, tounge felt thick/heavy, elevated heart rate, and heart began racing (consistent95-100 bpm) on 14-MAR-2021, and flu like symptoms on MAR-2021. This report was non-serious.
Sex: F
Vaccine: COVID19
Symptoms: Paraesthesia oral, Tongue oedema
Clinical narrative: FLU LIKE SYMPTOMS; TINGLING IN LIPS; TOUNGE FELT THICK/HEAVY; ELEVATED HEART RATE; HEART BEGAN RACING (CONSISTENT95-100 BPM); This spontaneous report received from a patient concerned a 24 year old female. The patient's height, and weight were not reported. The patient's past medical history included covid, breast cancer, skin cancer, and clot, and concurrent conditions included seafood allergy, erythromycin allergy, sulfa allergy, high cholesterol, thyroid, glucose intolerance, non-smoker, and non-alcoholic, and other pre-existing medical conditions included the patient has no history of drug abuse. patient height was 5'7 and weight was 220. patient did not have illness at the time of vaccination, has past history of similar events, did not have any adverse event after any previous vaccination, did not have any pre-existing acute illness 30 days prior to vaccination, no history of hospitalization in last 30 days with cause, no any family disease history, patient was not pregnant at the time of vaccination, and not breastfeeding at the time of reporting. The patient was previously treated with semaglutide for clot, and levothyroxine sodium. 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 13-MAR-2021 for prophylactic vaccination. Concomitant medications included paracetamol for cholesterol, atorvastatin for glucose intolerance, levothyroxine for thyroid disorder, and rivaroxaban for thyroid disorder. On 13-MAR-2021, the subject experienced tingling in lips. On 13-MAR-2021, the subject experienced tounge felt thick/heavy. On 13-MAR-2021, the subject experienced elevated heart rate. On 13-MAR-2021, the subject experienced heart began racing (consistent95-100 bpm). Laboratory data included: Heart rate (NR: not provided) 95-100 BPM. On 14-MAR-2021, the subject experienced flu like symptoms. Laboratory data included: Body temperature (NR: not provided) 100.1 F. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from tingling in lips, tounge felt thick/heavy, elevated heart rate, and heart began racing (consistent95-100 bpm) on 14-MAR-2021, and flu like symptoms on MAR-2021. This report was non-serious.