chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 31.0
Sex: F
Vaccine: COVID19
Symptoms: Pyrexia, Syncope, Unresponsive to stimuli
Clinical narrative: Syncope; Unresponsive to stimuli; Asthenia; Confusional state; Diarrhoea; Dizziness; Hyperventilation; Hypotension; Injection site bruising; Lethargy; Headache; Pyrexia; Fatigue; 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 SYNCOPE (Syncope) and UNRESPONSIVE TO STIMULI (Unresponsive to stimuli) in a 31-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 008b21-2a) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.    On 29-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 29-Mar-2021, the patient experienced SYNCOPE (Syncope) (seriousness criterion medically significant), UNRESPONSIVE TO STIMULI (Unresponsive to stimuli) (seriousness criterion medically significant), ASTHENIA (Asthenia), CONFUSIONAL STATE (Confusional state), DIARRHOEA (Diarrhoea), DIZZINESS (Dizziness), HYPERVENTILATION (Hyperventilation), HYPOTENSION (Hypotension), INJECTION SITE BRUISING (Injection site bruising), LETHARGY (Lethargy), HEADACHE (Headache), PYREXIA (Pyrexia) and FATIGUE (Fatigue). At the time of the report, SYNCOPE (Syncope), UNRESPONSIVE TO STIMULI (Unresponsive to stimuli), ASTHENIA (Asthenia), CONFUSIONAL STATE (Confusional state), DIARRHOEA (Diarrhoea), DIZZINESS (Dizziness), HYPERVENTILATION (Hyperventilation), HYPOTENSION (Hypotension), INJECTION SITE BRUISING (Injection site bruising), LETHARGY (Lethargy), HEADACHE (Headache), PYREXIA (Pyrexia) and FATIGUE (Fatigue) had resolved.        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.   Concomitant product use was not provided by the reporter. Treatment information was not provided.  Patient received vaccination at 10:45am and by 10:50am patient informed others she felt light headed. Nurse rushed to the patient with the Epi pen.  They observed patient head tilted backward and unresponsive. The patient started to response and become confused. Nurse didn't administer the Epi Pen.  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.
Age: 43.0
Sex: F
Vaccine: COVID19
Symptoms: Anaphylactic reaction, Dysphagia, Orbital swelling, Swelling face, Swollen tongue
Clinical narrative: Anaphylactic reaction; Dysphagia; Orbital swelling; Swelling face; Swollen tongue; 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 ANAPHYLACTIC REACTION (Anaphylactic reaction) in a 43-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 008B2121A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No medical history was provided.  Concomitant products included MULTIVITAMIN [VITAMINS NOS] for an unknown indication.    On 20-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 20-Mar-2021, the patient experienced ANAPHYLACTIC REACTION (Anaphylactic reaction) (seriousness criterion medically significant), DYSPHAGIA (Dysphagia), ORBITAL SWELLING (Orbital swelling), SWELLING FACE (Swelling face) and SWOLLEN TONGUE (Swollen tongue). At the time of the report, ANAPHYLACTIC REACTION (Anaphylactic reaction), DYSPHAGIA (Dysphagia), ORBITAL SWELLING (Orbital swelling), SWELLING FACE (Swelling face) and SWOLLEN TONGUE (Swollen tongue) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   Patient stated that no treatment medication was taken.; 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.
Age: 73.0
Sex: M
Vaccine: COVID19
Symptoms: Computerised tomogram normal, Extraocular muscle paresis, Facial pain, Headache, Vision blurred
Clinical narrative: Extraocular muscle paresis; Facial pain; Vision blurred; Headache; 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 EXTRAOCULAR MUSCLE PARESIS (Extraocular muscle paresis) in a 73-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 027A21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     Concurrent medical conditions included Diabetes mellitus, Hypertension, Hypertriglyceridemia and Hypothyroidism. Concomitant products included METFORMIN, TAMSULOSIN, ATORVASTATIN, PREGABALIN, LOSARTAN, LEVOTHYROXINE, TRAMADOL (AC TRAMADOL), CHLORPHENAMINE MALEATE, DEXTROMETHORPHAN HYDROBROMIDE, PARACETAMOL, PSEUDOEPHEDRINE HYDROCHLORIDE (TYLENOL COLD&COUGH) and ACETYLSALICYLIC ACID (ASPIRIN 81) for an unknown indication.    On 03-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 05-Mar-2021, the patient experienced EXTRAOCULAR MUSCLE PARESIS (Extraocular muscle paresis) (seriousness criterion medically significant), FACIAL PAIN (Facial pain), VISION BLURRED (Vision blurred) and HEADACHE (Headache). At the time of the report, EXTRAOCULAR MUSCLE PARESIS (Extraocular muscle paresis), FACIAL PAIN (Facial pain), VISION BLURRED (Vision blurred) and HEADACHE (Headache) had not resolved.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 05-Mar-2021, Computerised tomogram normal: normal (normal) Normal.     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.   No treatment drug information provided.; 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.
Age: 26.0
Sex: F
Vaccine: COVID19
Symptoms: Fear of injection, Loss of consciousness
Clinical narrative: Loss of consciousness; Fear of injection; 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 LOSS OF CONSCIOUSNESS (Loss of consciousness) in a 26-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 030B21a) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.    On 03-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 03-Apr-2021, the patient experienced LOSS OF CONSCIOUSNESS (Loss of consciousness) (seriousness criterion medically significant) and FEAR OF INJECTION (Fear of injection). At the time of the report, LOSS OF CONSCIOUSNESS (Loss of consciousness) and FEAR OF INJECTION (Fear of injection) had resolved.        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.   Patient was ok during her vaccine. Only after I finished the shot she passed out. We called 911 to make sure she was o.k. even though she said not to call.    It was unknown if the patient received any corrective treatment and concomitant medication.  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.
Age: 59.0
Sex: F
Vaccine: COVID19
Symptoms: Acute myocardial infarction
Clinical narrative: Acute myocardial infarction; 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 professional and describes the occurrence of ACUTE MYOCARDIAL INFARCTION (Acute myocardial infarction) in a 59-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 036A21A) for COVID-19 vaccination.     No Medical History information was reported.    On 07-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 09-Apr-2021, the patient experienced ACUTE MYOCARDIAL INFARCTION (Acute myocardial infarction) (seriousness criteria hospitalization and medically significant). The patient was hospitalized on sometime in April 2021 due to ACUTE MYOCARDIAL INFARCTION. At the time of the report, ACUTE MYOCARDIAL INFARCTION (Acute myocardial infarction) outcome was unknown.        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.   Patient was hospitalized for approximately 3 days and was treated in the Cath lab.  No concomitant medications was reported.  No treatment details were provided  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: FLUX
Symptoms: Influenza, Nasopharyngitis, Pyrexia, Vaccination failure
Clinical narrative: Vaccinated against flu three times / In each of those years / had at least one really bad cold with a high fever (can't tell if it was influenza)/Suspected vaccination failure; In each of those years / had at least one really bad cold with a high fever (can't tell if it was influenza); Really bad cold; High fever; This case was reported by a consumer via media and described the occurrence of suspected vaccination failure in a male patient who received Flu unspecified (Flu vaccine) for prophylaxis.   On an unknown date, the patient received Flu vaccine. On an unknown date, less than a year after receiving Flu vaccine, the patient experienced vaccination failure (serious criteria GSK medically significant), influenza, cold and fever. On an unknown date, the outcome of the vaccination failure, influenza, cold and fever were unknown.   It was unknown if the reporter considered the vaccination failure, influenza, cold and fever to be related to Flu vaccine.  Additional details were reported as follows: This case was reported by patient himself. The age at vaccination was not reported. The patient got vaccinated against flu and in that year after that he had one really bad cold with a high fever and stated he could not tell if it was influenza. This case was considered as suspected vaccination failure as details regarding time to onset and laboratory test confirming influenza were unknown at the time of reporting. The follow-up would not possible as no contact details were available. For tolerance of other 2 doses refer case US2021AMR118022 and US2021AMR118023, reported by same reporter. Note: As the patient was not sure for influenza, hence considering the worst case approach captured influenza along with vaccination failure as event.; Sender's Comments:  US-GLAXOSMITHKLINE-US2021AMR118022:Same reporter. US-GLAXOSMITHKLINE-US2021AMR118023:Same reporter.
Sex: M
Vaccine: FLUX
Symptoms: Influenza, Nasopharyngitis, Pyrexia, Vaccination failure, Vaccine positive rechallenge
Clinical narrative: Vaccinated against flu three times / In each of those years / had at least one really bad cold with a high fever (can't tell if it was influenza)/ Suspected vaccination failure; In each of those years / had at least one really bad cold with a high fever (can't tell if it was influenza); Really bad cold; High fever; This case was reported by a consumer via media and described the occurrence of vaccination failure in a male patient who received Flu unspecified (Flu vaccine) for prophylaxis.   Previously administered products included Flu vaccine with an associated reaction of vaccination failure (also experienced influenza and bad cold with a high fever after receiving on an unknown date, refer case US2021AMR117937).   On an unknown date, the patient received Flu vaccine. On an unknown date, less than a year after receiving Flu vaccine, the patient experienced vaccination failure (serious criteria GSK medically significant), influenza, cold and fever. Rechallenge with Flu vaccine was positive. On an unknown date, the outcome of the vaccination failure, influenza, cold and fever were unknown.   It was unknown if the reporter considered the vaccination failure, influenza, cold and fever to be related to Flu vaccine.  Additional details were reported as follows: This case was reported by patient himself. The age at vaccination was not reported. The patient got vaccinated against flu and in that year after that he had one really bad cold with a high fever and stated he could not tell if it was influenza. This case was considered as suspected vaccination failure as details regarding time to onset and laboratory test confirming influenza were unknown at the time of reporting. The follow-up would not possible as no contact details were available. For tolerance of last dose refer case US2021AMR118023. This case is one of 3 cases, reported by the same reporter. Note: As the patient was not sure for influenza, hence considering the worst case approach captured influenza along with vaccination failure as event.; Sender's Comments:  US-GLAXOSMITHKLINE-US2021AMR117937:Same reporter. US-GLAXOSMITHKLINE-US2021AMR118023:Same reporter.
Sex: M
Vaccine: FLUX
Symptoms: Influenza, Nasopharyngitis, Pyrexia, Vaccination failure, Vaccine positive rechallenge
Clinical narrative: Vaccinated against flu three times / In each of those years / had at least one really bad cold with a high fever (can't tell if it was influenza)/Suspected vaccination failure; In each of those years / had at least one really bad cold with a high fever (can't tell if it was influenza); Really bad cold; High fever; This case was reported by a consumer via media and described the occurrence of suspected vaccination failure in a male patient who received Flu unspecified (Flu vaccine) for prophylaxis.   Previously administered products included Flu vaccine with an associated reaction of vaccination failure (also experienced influenza and bad cold with a high fever after receiving on an unknown date, refer case US2021AMR117937) and Flu vaccine with an associated reaction of vaccination failure (also experienced influenza and bad cold with a high fever after receiving on an unknown date, refer case US2021AMR118022).   On an unknown date, the patient received Flu vaccine. On an unknown date, less than a year after receiving Flu vaccine, the patient experienced vaccination failure (serious criteria GSK medically significant), influenza, cold and fever. Rechallenge with Flu vaccine was positive. On an unknown date, the outcome of the vaccination failure, influenza, cold and fever were unknown.   It was unknown if the reporter considered the vaccination failure, influenza, cold and fever to be related to Flu vaccine.  Additional details were reported as follows: This case was reported by patient himself. The age at vaccination was not reported. The patient got vaccinated against flu and in that year after that he had one really bad cold with a high fever and stated he could not tell if it was influenza. This case was considered as suspected vaccination failure as details regarding time to onset and laboratory test confirming influenza were unknown at the time of reporting. The follow-up would not possible as no contact details were available. This case is one of 3 cases, reported by the same reporter. Note: As the patient was not sure for influenza, hence considering the worst case approach captured influenza along with vaccination failure as event. ; Sender's Comments:  US-GLAXOSMITHKLINE-US2021AMR118022:Same reporter. US-GLAXOSMITHKLINE-US2021AMR117937:Same reporter.
Sex: U
Vaccine: FLU4
Symptoms: Pain in extremity
Clinical narrative: Only side effect would be my arm is sore. Just like w/ the flu / vaccine; This case was reported by a consumer via other manufacturer and described the occurrence of pain in arm in a patient who received Flu Seasonal QIV Dresden (Influenza vaccine Quadrivalent unspecified season) for prophylaxis.   Previously administered products included Tetanus Vaccine with an associated reaction of pain in extremity.   On an unknown date, the patient received Influenza vaccine Quadrivalent unspecified season. On an unknown date, unknown after receiving Influenza vaccine Quadrivalent unspecified season, the patient experienced pain in arm. On an unknown date, the outcome of the pain in arm was unknown.   It was unknown if the reporter considered the pain in arm to be related to Influenza vaccine Quadrivalent unspecified season.  Additional details were provided as follows: The case was reported by the patient for herself/himself The age at vaccination was not reported. The patient had received flu vaccine and arm was sore. The patient had same side effect with the Tetanus and Pfizer vaccine. Patient had Ibuprofen as treatment for Covid vaccine side effect.
Sex: U
Vaccine: HEPA
Symptoms: Overdose, Product administered to patient of inappropriate age
Clinical narrative: pediatric patients (children) were given the adult dose of Havrix.; pediatric patients (children) were given the adult dose of Havrix.; This case was reported by a physician via call center representative and described the occurrence of overdose in a child patient who received HAV (Havrix 1440) for prophylaxis.   On an unknown date, the patient received Havrix 1440. On an unknown date, unknown after receiving Havrix 1440, the patient experienced overdose and adult product administered to child. On an unknown date, the outcome of the overdose and adult product administered to child were unknown.  Additional details were provided as follows: The reporter was a pediatrician. The age at vaccination was not reported. The pediatric patient was given the adult dose of Havrix, which led to overdose and adult product administered to child. The pediatrician´s office was still trying to identify the patient. Patient identifiers was not available till the time of reporting. The reporter consented to follow up. This is 1 of the 9 link cases, reported by same reporter.; Sender's Comments:  US-GLAXOSMITHKLINE-US2021120523:same reporter US-GLAXOSMITHKLINE-US2021120525:same reporter US-GLAXOSMITHKLINE-US2021120526:same reporter US-GLAXOSMITHKLINE-US2021120528:same reporter US-GLAXOSMITHKLINE-US2021120519:same reporter US-GLAXOSMITHKLINE-US2021120521:same reporter US-GLAXOSMITHKLINE-US2021120516:same reporter US-GLAXOSMITHKLINE-US2021120532:same reporter
Age: 0.17
Sex: F
Vaccine: DTAPHEPBIP, HEP, IPV
Symptoms: Accidental overdose
Clinical narrative: Pediarix, single dose hepB / single dose Polio, all at 2 month visit / was human error; This case was reported by a other health professional via sales rep and described the occurrence of accidental overdose in a 2-month-old female patient who received DTPa-HBV-IPV (Pediarix) for prophylaxis.   Co-suspect products included dtpa-hbv-ipv vaccine pre-filled syringe device (Pediarix Pre-Filled Syringe Device) injection syringe for prophylaxis, Hepatitis B vaccine for prophylaxis and POLIOMYELITIS VACCINE (POLIO VACCINE) for prophylaxis.   On an unknown date, the patient received Pediarix, Pediarix Pre-Filled Syringe Device, Hepatitis B vaccine and POLIO VACCINE. On an unknown date, unknown after receiving Pediarix, Pediarix Pre-Filled Syringe Device and Hepatitis B vaccine, the patient experienced accidental overdose. On an unknown date, the outcome of the accidental overdose was 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: Health care professional reported that the patient received single dose of Pediarix, Hepatitis B and Polio at 2 months visit, which led to accidental overdose. No other information was reported. The reporter consented to follow up.
Sex: F
Vaccine: VARZOS
Symptoms: Incomplete course of vaccination, No reaction on previous exposure to drug
Clinical narrative: Patient is 17 months out from 1st dose / 2nd dose still valid or should she restart; This case was reported by a other health professional via Shingrix GSK interactive digital media 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 with an associated reaction of no adverse event (received 1st dose of Shingrix, 17 months ago prior to 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. Till the time of vaccination, the patient did not receive 2nd dose of Shingrix, which led to incomplete course of vaccination. The reporter enquired if the second dose was still valid or the patient  should restart the series.
Sex: U
Vaccine: VARZOS
Symptoms: Incomplete course of vaccination
Clinical narrative: patient does not get the second dose in the scheduled time frame; This case was reported by a consumer via Shingrix GSK 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 on an unknown date).   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. Till the time of reporting, the patient did not get the 2nd dose of Shingrix in the scheduled time frame which led to incomplete course of vaccination. The reporter asked that do they just administer the dose and call it good or they need a 3rd catchup dose. The follow-up would not possible as no contact details were available
Sex: U
Vaccine: VARZOS
Symptoms: Herpes zoster, Pain, Scar, Skin injury, Vaccination failure
Clinical narrative: Suspected vaccination failure/ Had the vaccine on December 18, 2020 / breaking out with Shingles around April 1, 2021; Breaking out with Shingles around April 1, 2021; The outbreak was severe with pain; Permanent scars on my nose and face from the shingles; Damage to my face and body; This case was reported by a consumer and described the occurrence of suspected vaccination failure in a patient who received Herpes zoster (Shingrix) for prophylaxis.   On 18th December 2020, the patient received Shingrix. On 1st April 2021, 104 days after receiving Shingrix, the patient experienced vaccination failure (serious criteria GSK medically significant), shingles, pain, scar and injury. On an unknown date, the outcome of the vaccination failure, shingles, pain, scar and injury were unknown.   It was unknown if the reporter considered the vaccination failure, shingles, pain, scar and injury to be related to Shingrix.  Additional details were provided as follows: The patient reported case for herself/himself. The age at vaccination was not reported. The patient had the Shingrix vaccine on the recommendation of the physician and started breaking out with Shingles around 1st April 2021. The outbreak was severe with pain. The patient has permanent scars on the nose and face from the shingles. The patient stated that he/she could send the pictures of the scars and damage to the face and body for review. The patient stated he/she would prefer to deal directly with GlaxoSmithKline on a settlement, instead of dealing with outside counsel with thousands of clients and being just a number. This case was considered to be a suspected vaccination failure case, as the details regarding being full vaccination schedule and laboratory confirmation for shingles were unknown.
Sex: U
Vaccine: VARZOS
Symptoms: Herpes zoster, Vaccination failure
Clinical narrative: got the shingle shot but I still had a light case of the shingles years later/ suspected vaccination failure; had a light case of the shingles; This case was reported by a consumer via media and described the occurrence of suspected vaccination failure in a patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   On an unknown date, the patient received Shingles vaccine. On an unknown date, unknown after receiving Shingles vaccine, the patient experienced vaccination failure (serious criteria GSK medically significant) and shingles. On an unknown date, the outcome of the vaccination failure and shingles were unknown.   It was unknown if the reporter considered the vaccination failure and shingles to be related to Shingles vaccine.  Additional details were provided as follows: The patient reported case for herself/himself. The age at vaccination was not reported. The patient got the shingle shot but still had a light case of the shingles years later but the patient did recommend to get the shot. This case was considered to be a suspected vaccination failure case, as the details regarding being full vaccination schedule, laboratory confirmation for shingles and exact time to onset were unknown.
Sex: U
Vaccine: VARZOS
Symptoms: Herpes zoster, Vaccination failure
Clinical narrative: got the vaccine and some years later got a mild case/ suspected vaccination failure; got a mild case.; This case was reported by a consumer via media and described the occurrence of suspected vaccination failure in a patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   On an unknown date, the patient received Shingles vaccine. On an unknown date, several years after receiving Shingles vaccine, the patient experienced vaccination failure (serious criteria GSK medically significant) and shingles. On an unknown date, the outcome of the vaccination failure and shingles were unknown.   It was unknown if the reporter considered the vaccination failure and shingles to be related to Shingles vaccine.  Additional details were provided as follows: The patient reported case for herself/himself. The age at vaccination was not reported. The patient got the vaccine and some years later got a mild case of shingles. The patient stated if that was mild he/she cannot even imagine what a full blown case would be like. The patient recommended to get the vaccine. This case was considered to be a suspected vaccination failure case, as the details regarding being full vaccination schedule, laboratory confirmation for shingles were unknown.
Sex: U
Vaccine: VARZOS, VARZOS
Symptoms: Herpes zoster, Pain, Vaccination failure
Clinical narrative: Three to four years after vaccines, the first case / the second was / 5 months after the first/Suspected vaccination failure; First case was near my tail bone / second was / 5 months after the first; Second was a mere 5 months after the first, less painful, but lingered longer; This case was reported by a consumer via media and described the occurrence of suspected vaccination failure in a patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   Co-suspect products included Herpes zoster (Shingles vaccine) for prophylaxis.   On an unknown date, the patient received the 2nd dose of Shingles vaccine and the 1st dose of Shingles vaccine. On an unknown date, more than 2 years after receiving Shingles vaccine and Shingles vaccine, the patient experienced vaccination failure (serious criteria GSK medically significant), shingles and pain. On an unknown date, the outcome of the vaccination failure, shingles and pain were unknown.   It was unknown if the reporter considered the vaccination failure, shingles and pain to be related to Shingles vaccine and Shingles vaccine.  Additional details were reported as follows: The case was reported by the patient. The age at vaccination was not reported. The patient experienced 2nd case of shingles a mere 5 months after the 1st case of shingles and stated shingles was less painful, but lingered longer. This case was considered to be a suspected vaccination failure case, as the details regarding laboratory confirmation for shingles was unknown. For 1st outbreak of shingles refer linked case US2021AMR118138, reported by the same reporter.; Sender's Comments:  US-GLAXOSMITHKLINE-US2021AMR118138:Same reporter, same patient, 1st shingles outbreak
Sex: U
Vaccine: VARZOS, VARZOS
Symptoms: Condition aggravated, Herpes zoster, Neuralgia, Oral herpes, Vaccination failure
Clinical narrative: Got the shots / Oral shingle in my mouth and lips/Suspected vaccination failure; Shingles; Oral shingle in my mouth and lips; Nerve pain; This case was reported by a consumer via media and described the occurrence of suspected vaccination failure in a patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   Co-suspect products included Herpes zoster (Shingles vaccine) for prophylaxis.   The patient's past medical history included shingles (had shingles in 2012).   On an unknown date, the patient received the 2nd dose of Shingles vaccine and the 1st dose of Shingles vaccine. On an unknown date, unknown after receiving Shingles vaccine and Shingles vaccine, the patient experienced vaccination failure (serious criteria GSK medically significant), shingles, oral herpes and nerve pain. On an unknown date, the outcome of the vaccination failure, shingles, oral herpes and nerve pain were unknown.   It was unknown if the reporter considered the vaccination failure, shingles, oral herpes and nerve pain to be related to Shingles vaccine and Shingles vaccine.  Addition details were reported as follows: The case was reported by the patient. The age at vaccination was not reported. The patient got the shingles shots couple of months before the reporting and as a side effect of the shots, the patient had oral shingles in mouth and lips and at present the patient on 2 kinds of medication to prevent the nerve pain. This case was considered as suspected vaccination failure as details regarding time to onset and laboratory confirmation were unknown at the time of reporting. The follow up would not be possible as no contact details were available.
Sex: F
Vaccine: VARZOS
Symptoms: Herpes zoster, Vaccination failure
Clinical narrative: Wife had the shot and has the Shingles/Suspected vaccination failure; Shingles right now, really bad / going thru living HELL; This case was reported by a consumer via media and described the occurrence of suspected vaccination failure in a female patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   On an unknown date, the patient received Shingles vaccine. On an unknown date, unknown after receiving Shingles vaccine, the patient experienced vaccination failure (serious criteria GSK medically significant) and shingles. On an unknown date, the outcome of the vaccination failure and shingles were unknown.   It was unknown if the reporter considered the vaccination failure and shingles to be related to Shingles vaccine.  Additional details were reported as follows: The case was reported by the patient's spouse. The age at vaccination was not reported. The patient got the shingles shot and right now she was going through living hell. The shingles was not preventable and it was really bad. This case was considered as suspected vaccination failure as details regarding completion of primary vaccination schedule, time to onset and laboratory confirmation were unknown at the time of reporting. The follow up would not be possible as no contact details were available.
Sex: U
Vaccine: VARZOS
Symptoms: Herpes zoster, Pain, Vaccination failure
Clinical narrative: Had shingles three times...even after the shot/Suspected vaccination failure; Had shingles three times...even after the shot; Best thing for pain is lidocaine patch; This case was reported by a consumer via media and described the occurrence of Suspected vaccination failure in a patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   On an unknown date, the patient received Shingles vaccine. On an unknown date, unknown after receiving Shingles vaccine, the patient experienced vaccination failure (serious criteria GSK medically significant), shingles and pain. The patient was treated with lidocaine (Lidocaine Patch). On an unknown date, the outcome of the vaccination failure and shingles were unknown and the outcome of the pain was recovered/resolved.   It was unknown if the reporter considered the vaccination failure, shingles and pain to be related to Shingles vaccine.  Additional details were provided as follows: The case was reported by patient itself. The age at vaccination was not reported. Even after receiving Shingles vaccine, the had Shingles three time. The patient stated that best thing for pain was lidocaine patch for immediate relief. This case was considered as suspected vaccination failure as details regarding completion of primary vaccination schedule, laboratory confirmation, time to onset of shingles were unknown at the time of reporting.
Sex: M
Vaccine: VARZOS
Symptoms: Herpes zoster, Vaccination failure
Clinical narrative: I got the shingles shot and had a few on my right side/ Suspected vaccination failure; I got the shingles shot and had a few on my right side; This case was reported by a consumer via media and described the occurrence of suspected vaccination failure in a male patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   On an unknown date, the patient received Shingles vaccine. On an unknown date, unknown after receiving Shingles vaccine, the patient experienced vaccination failure (serious criteria GSK medically significant) and shingles. On an unknown date, the outcome of the vaccination failure was unknown and the outcome of the shingles was recovered/resolved.   It was unknown if the reporter considered the vaccination failure and shingles to be related to Shingles vaccine.  Additional details were reported as follows: This case was reported by patient himself/herself. The age at vaccination was not reported. The patient received Shingles vaccine and had a few shingles on his/her right side. The patient stated that he/she did not had any pain and they were gone in a few days. This case was considered as suspected vaccination failure as details regarding completion of primary vaccination schedule, time to onset and laboratory test confirming herpes zoster were unknown at the time of reporting. The follow-up would not possible as no contact details were available.
Sex: U
Vaccine: VARZOS, VARZOS
Symptoms: Herpes zoster, Pain, Rash macular, Vaccination failure
Clinical narrative: I had both shots WELL I have the shingles/suspect vaccination failure; I have the shingles; RED SPOTS; BUT SOME PAIN; This case was reported by a consumer via media and described the occurrence of suspected vaccination failure in a patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   Co-suspect products included Herpes zoster (Shingles vaccine) for prophylaxis.   On an unknown date, the patient received the 1st dose of Shingles vaccine and the 2nd dose of Shingles vaccine. On an unknown date, unknown after receiving Shingles vaccine and Shingles vaccine, the patient experienced vaccination failure (serious criteria GSK medically significant), shingles, red spotty rash and pain. On an unknown date, the outcome of the vaccination failure, shingles, red spotty rash and pain were unknown.   It was unknown if the reporter considered the vaccination failure, shingles, red spotty rash and pain to be related to Shingles vaccine and Shingles vaccine.  Additional details were reported as follows: This case was reported by patient himself/herself. The age at vaccination was not reported. The patient received both the doses of Shingles vaccine and had shingles, red spots and some pain. The patient stated that the vaccine sure did not help him/her. This case was considered as suspected vaccination failure as details regarding time to onset and laboratory test confirming herpes zoster were unknown at the time of reporting.
Sex: U
Vaccine: VARZOS, VARZOS
Symptoms: Herpes zoster, Pain, Vaccination failure
Clinical narrative: I got the vaccine with the booster last year. I now have shingles/despite the shot/ Suspected vaccination failure; I now have shingles on my back and side; Worst pain ever; This case was reported by a consumer via media and described the occurrence of suspected vaccination failure in a patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   Co-suspect products included Herpes zoster (Shingles vaccine) for prophylaxis.   On an unknown date, the patient received the 1st dose of Shingles vaccine and the 2nd dose of Shingles vaccine. On an unknown date, less than 2 years after receiving Shingles vaccine and Shingles vaccine, the patient experienced vaccination failure (serious criteria GSK medically significant), shingles and pain. On an unknown date, the outcome of the vaccination failure and pain were unknown and the outcome of the shingles was not recovered/not resolved.   It was unknown if the reporter considered the vaccination failure, shingles and pain to be related to Shingles vaccine and Shingles vaccine.  Additional details were reported as follows: This case was reported by patient himself/herself. The age at vaccination was not reported. In 2020, last year, the patient received Shingles vaccine with the booster and at the time of reporting, he/she had shingles on back and side. The patient stated that he/she had worst pain ever. This case was considered as suspected vaccination failure as detail regarding laboratory test confirming herpes zoster was unknown at the time of reporting. The follow-up would not possible as no contact details were available.
Sex: M
Vaccine: VARZOS
Symptoms: Incomplete course of vaccination, No reaction on previous exposure to drug
Clinical narrative: first dose of Shingrix on 1/4/2020/ has not yet received the second; This case was reported by a consumer via call center representative and described the occurrence of incomplete course of vaccination in a male 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 4th January 2020, batch number-L9F99, expiration date-10th May 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 reporter was the wife of the patient. The age at vaccination was not applicable for this report. Till the time of reporting, patient did not received 2nd dose of Shingrix, which led to incomplete course of vaccination. The reporter stated that, the patient had only provided year of birth which is 1950. The reporter did not consented to follow up. The case is linked with US2021117062, reported by same reporter.; Sender's Comments:  US-GLAXOSMITHKLINE-US2021117062:same reporter
Sex: F
Vaccine: VARZOS
Symptoms: Fatigue
Clinical narrative: fatigue and a lot of fatigue / still has the fatigue today; This case was reported by a consumer and described the occurrence of fatigue in a adult female patient who received Herpes zoster (Shingrix) for prophylaxis.   Concomitant products included COVID-19 VACCINE (COVID 19 VACCINE).   On 29th May 2021, the patient received the 1st dose of Shingrix. On 29th May 2021, less than a day after receiving Shingrix, the patient experienced fatigue. On an unknown date, the outcome of the fatigue was not recovered/not resolved.   It was unknown if the reporter considered the fatigue to be related to Shingrix.  Additional details was reported as follows: The age at vaccination was not reported. The patient received Shingrix 3 days ago and experienced fatigue the first night and a lot fatigue the second and third night . The reporter stated that she had received Covid 19 shot 2months ago. The patient still had the fatigue today. The reporter did not consented to follow up. The case is linked with US2021117068, reported by same reporter.; Sender's Comments:  US-GLAXOSMITHKLINE-US2021117068:same reporter
Age: 2.0
Sex: F
Vaccine: DTAPIPV
Symptoms: No adverse event, Product administered to patient of inappropriate age
Clinical narrative: Administered the / vaccine to a child that was under the age; This case was reported by a nurse via call center representative and described the occurrence of inappropriate age at vaccine administration in a 2-year-old female patient who received DTPa-IPV (Kinrix) (batch number D24G7, expiry date 4th June 2022) for prophylaxis.   Co-suspect products included dtpa-ipv vaccine pre-filled syringe device (Kinrix Pre-Filled Syringe Device) injection syringe for prophylaxis.   On an unknown date, the patient received Kinrix (intramuscular) and Kinrix Pre-Filled Syringe Device. On an unknown date, unknown after receiving Kinrix and Kinrix 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 details were provided as follows: The reporter administered the Kinrix vaccine to the patient that was under the age to receive the vaccine which led to inappropriate age at vaccine administration.  The reporter provided all information and stated, there were no reported adverse events with the patient at the time of reporting.  The reporter stated that she knew the patient was due for the DTaP and Polio vaccines. The reporter consented to follow up.
Age: 61.0
Sex: F
Vaccine: VARZOS
Symptoms: Feeling abnormal, Insomnia
Clinical narrative: was suffering from insomnia; feels slightly elevated / possibly her heart rate; This case was reported by a consumer via call center representative and described the occurrence of insomnia in a 61-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   Concurrent medical conditions included hypothyroidism.   On 27th May 2021, the patient received the 1st dose of Shingrix. On an unknown date, less than a week after receiving Shingrix, the patient experienced insomnia and feeling abnormal. On an unknown date, the outcome of the insomnia and feeling abnormal were not recovered/not resolved.   The reporter considered the insomnia and feeling abnormal to be related to Shingrix.  Additional details provided were as follows: The patient had hypothyroidism and takes thyroid medicine. The patient was suffering from insomnia and stated that she felt slightly elevated like possibly her heart rate and states it felt as if she took 2 doses of her thyroid medicine.  The patient did not know the lot number or expiration date.  The reporter consented to follow-up.
Sex: M
Vaccine: VARZOS
Symptoms: Incomplete course of vaccination
Clinical narrative: Second dose had not been administered at time of the call; This case was reported by a pharmacist via call center representative and described the occurrence of incomplete course of vaccination in a male patient who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included Shingrix (received 1st dose at the end of 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 to this report. The reporter called in regards of a late second dose of Shingrix and till the time of reporting, the patient had not been administered the 2nd dose, which led to incomplete course of vaccination. The reporter did not have the patient information since patient came by to ask and left, also no vaccine information available. The reporter did not consent to follow-up.
Age: 0.92
Sex: F
Vaccine: DTAPIPV
Symptoms: Inappropriate schedule of product administration, Product administered to patient of inappropriate age
Clinical narrative: 11 month old patient had been given Kinrix; Kinrix 3rd dose in the DTaP series and the 3rd dose in the polio series; This case was reported by a physician via call center representative and described the occurrence of inappropriate age at vaccine administration in a 11-month-old female patient who received DTPa-IPV (Kinrix) (batch number YZ97N, expiry date 26th August 2022) for prophylaxis.   Co-suspect products included dtpa-ipv vaccine pre-filled syringe device (Kinrix Pre-Filled Syringe Device) injection syringe for prophylaxis.   Previously administered products included HEPATITIS B VACCINE (received prior 3 doses of series on an unknown date) and DTPa-IPV (received prior 3 doses of series on an unknown date).   On 2nd June 2021, the patient received the 3rd dose of Kinrix and Kinrix Pre-Filled Syringe Device. On 2nd June 2021, unknown after receiving Kinrix and Kinrix Pre-Filled Syringe Device, the patient experienced inappropriate age at vaccine administration and inappropriate schedule of vaccine administered. On an unknown date, the outcome of the inappropriate age at vaccine administration and inappropriate schedule of vaccine administered 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: The age at vaccination was not reported. The patient received Kinrix at 11 months of age, which led to inappropriate age at vaccine administration. The patient received Kinrix to provide the 3rd dose in the DTaP series and the 3rd dose in the polio series, which led to inappropriate schedule of vaccine administered. The Pediarix was to be given but patient had completed 3 doses of Hepatitis B already. At the time of reporting, the dose was given and after realizing age recommendations on health care professional called for safety and composition information. Health care professional did not have all information at hand and provided limited data, initials not shared. The reporter consented to follow up.