chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 11.0
Sex: F
Vaccine: HPV9, HPV9
Symptoms: Inappropriate schedule of product administration, Oropharyngeal pain, Pyrexia
Clinical narrative: Fever; Sore throat; A patient received a dose of GARDASIL 9 on 08-AUG-2019 and on 21-JUL-2020; This spontaneous report was received from a physician referring to a 12 years old female patient. Information about pertinent medical history included attention deficit hyperactivity disorder (ADHD). The patient had no drug reactions or allergies. The patient's concomitant therapy included "QUILLICHEW extended-release (ER)".  08-AUG-2019, the patient was vaccinated with a dose of hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast) (GARDASIL 9) injection (lot # R009615 with expiration date 12-JUL-2020, dose detail was not reported) via intramuscular route for prophylaxis (reported as to prevent human papilloma virus (HPV)).  On 21-JUL-2020, the patient was vaccinated with another dose of hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast) (GARDASIL 9) injection (lot# 1621926 with expiration date 28-NOV-2021, dose detail was not reported) via intramuscular route for prophylaxis (reported as to prevent HPV) (inappropriate schedule of product administration, onset date was on 07-MAY-2020).   On the same date (reported as starting right after the dose on 21-JUL-2020), the patient developed a sore throat and fever. The peak fever temperature was 102. 5 degree Fahrenheit (F). The patient called the physician for seeking medical attention and she took ibuprofen and acetaminophen (TYLENOL) as treatment for the events. There was no lab diagnostics or studies were performed. At the reporting time, the patient had not recovered from the events of sore throat and fever. combinationproductreport: Yes; brandname: GARDASIL 9 SYRINGE (DEVICE); commondevicename: HPV rL1 6 11 16 18 31 33 45 52 58 VLP vaccine (yeast); productcode: FMF; devicetype: SYRINGE, PISTON (FMF); manufacturername: Merck Sharp & Dohme Corp.; devicelotnumber: 1621926; expirationdate: 28-NOV-2021; deviceage and unit: 0 ; malfunction: Unknown; productavailableforevaluation: No; deviceusage: Unknown; evaluatedbymfr: Not returned to manufacturer; reasonfornoneval: 81 Other; labeledsingleusedevice: No; mdcpreportability: No; mdcpreprationale: Case information does not meet the criteria for Reportability
Sex: U
Vaccine: PPV
Symptoms: Expired product administered
Clinical narrative: a patient was administered a properly stored but expired dose of PNEUMOVAX 23; This spontaneous report was received from an office manager referring to a patient of unknown age and gender. The patient's concomitant medication, pertinent medical history and drug reactions/ allergies were not reported.  On 24-JUL-2020 the patient was vaccinated with a properly stored but expired dose of pneumococcal vaccine, polyvalent (23-valent) (PNEUMOVAX23) (1 dose, lot # R012550, expiration date 25-JAN-2020; dose and route was not reported) for prophylaxis (experienced expired product administered). No additional event information. The product was not available for investigation (obtain was reported as false). combinationproductreport: Yes; brandname: PNEUMOVAX23 SYRINGE (DEVICE); commondevicename: Pneumococcal Vaccine, Polyvalent (23-valent); productcode: FMF; devicetype: SYRINGE, PISTON (FMF); manufacturername: Merck Sharp & Dohme Corp.; manufactureraddress:; manufacturercity:; manufacturerstate:; manufacturercountry:; devicelotnumber: R012550; expirationdate: 25-JAN-2020; deviceage and unit: 0 ; malfunction: Unknown; productavailableforevaluation: No; deviceusage: Unknown; evaluatedbymfr: Not returned to manufacturer; reasonfornoneval: 81 Other; labeledsingleusedevice: No; mdcpreportability: No; mdcpreprationale: Case information does not meet the criteria for Reportability
Sex: F
Vaccine: VARZOS
Symptoms: Cerebrovascular accident, Dysarthria, Encephalopathy
Clinical narrative: cerebrovascular accident; encephalopathy; dysarthria; This initial spontaneous report was received from a lawyer regarding a case in litigation and refers to an adult, female patient (pt). No information was provided regarding the pt's medical history, concurrent conditions or concomitant medications.  On or about 05-MAY-2016, the pt was vaccinated with a dose of zoster vaccine live (ZOSTAVAX) (exact dose, site and route of administration, lot# and expiration date were not specified) for the long-term prevention of shingles and zoster-related conditions. On an unknown date (reported as subsequently), the pt experienced cerebrovascular accident, dysarthria and encephalopathy and was treated for the events by a healthcare provider.  The outcome of the events was unknown. The reporter considered the events to be related to zoster vaccine live (ZOSTAVAX).  Upon internal review, the events of cerebrovascular accident and encephalopathy were determined to be medically significant.
Sex: F
Vaccine: VARCEL
Symptoms: Antibody test negative, No adverse event, Product storage error
Clinical narrative: the VARIVAX titer was "too low".; the patient received a second dose of VARIVAX. The second dose received was improperly stored; This spontaneous report was received from a pharmacist and refers to a 28-year-old female patient. There was no information about the patient's concurrent conditions, allergies, drug reactions, concomitant therapies or provided. On an unknown date, in the past the patient received a first dose of varicella virus vaccine live (oka/merck)(VARIVAX) via subcutaneous route (dose, lot #, expiration date, anatomical location of administration were not reported) for prophylaxis. Then, on unspecified date, after first vaccination, she received a titer which showed that the varicella virus vaccine live (oka/merck)(VARIVAX) titer was "too low".  On 02-JUL-2020, she received second dose of varicella virus vaccine live (oka/merck)(VARIVAX) (lot # S019584, expiration date: 25-JUN-2021) via subcutaneous route (dose, anatomical location of administration were not reported) for vaccination for school. The second dose received was improperly stored but reconstituted with properly stored sterile diluent (Merck DILUENT)(lot# and expiration date were not provided). No symptoms were reported.  The temperature to which the vaccine was exposed was from 15 degrees of Fahrenheit (F) to 46 F (24F) and the time frame was reported as 16 hours 15 minutes. No previous temperature excursions were reported. A data logger was used. The outcome of the events was not reported. The causality assessment between the event of the event of antibody test negative and varicella virus vaccine live (oka/merck) (VARIVAX) was not provided.
Age: 8.0
Sex: U
Vaccine: HEPA, UNK
Symptoms: Expired product administered, No adverse event
Clinical narrative: no other adverse effects were reported in the patient; received a dose of VAQTA that had expired; This spontaneous report has been received from a nurse regarding a 8-years-old patient of unknown gender. The patient's concurrent conditions, historical conditions and concomitant medications were not reported.   On 27-JUL-2020, the patient was vaccinated with an expired dose of Hepatitis A Vaccine, Inactivated (VAQTA) 25/0.5 (units not reported), at a dose of 0.5 milliliter (route of administration not reporter; lot # S007768 has been verified to be a valid lot number for Hepatitis A Vaccine, Inactivated (VAQTA), expiration date 24-JUL-2020). No other adverse effects were reported in the patient. combinationproductreport: Yes; brandname: VAQTA SYRINGE (DEVICE); commondevicename: Hepatitis A Vaccine, Inactivated; productcode: FMF; devicetype: SYRINGE, PISTON (FMF); manufacturername: Merck Sharp & Dohme Corp. ; devicelotnumber: S007768; expirationdate: 24-JUL-2020; deviceage and unit: 0 ; malfunction: Unknown; deviceusage: Unknown; evaluatedbymfr: Not returned to manufacturer; reasonfornoneval: 81 Other; labeledsingleusedevice: No; mdcpreportability: No; mdcpreprationale: Case information does not meet the criteria for Reportability
Age: 13.0
Sex: F
Vaccine: HPV4
Symptoms: Fibromyalgia, Loss of consciousness
Clinical narrative: The patient passed out and later she was diagnosed with fibromyalgia; The patient passed out and later she was diagnosed with fibromyalgia; unspecified health issues; This spontaneous report was received from a consumer via a company representative, concerning a 13-years-old female patient. The patient's medical history, concurrent condition, concomitant medications, and drug allergies were not reported.   On an unknown date, the patient was vaccinated with the first dose of quadrivalent human papillomavirus (Types 6,11,16,18) recomb. vaccine (GARDASIL) for prophylaxis (route of administration, vaccine schedule, anatomical location, lot number, and expiration date were not reported).   In approximately 2005 (reported as 15-13 years ago), after the second dose of quadrivalent human papillomavirus (Types 6,11,16,18) recomb. vaccine (GARDASIL) for prophylaxis (route of administration, vaccine schedule, anatomical location, lot number, and expiration date were not reported), the patient passed out (loss of consciousness). Subsequently, the patient was diagnosed with fibromyalgia.   It was reported that she believed that fibromyalgia and other unspecified health issues (III-defined disorder) stem from quadrivalent human papillomavirus (Types 6,11,16,18) recomb. vaccine (GARDASIL) injection.  At the reporting time, it was unknown if the patient recovered from the events. The causal relationship between the loss of consciousness and vaccination with quadrivalent human papillomavirus (Types 6,11,16,18) recomb. vaccine (GARDASIL) was not provided.  Upon internal review, the event loss of consciousness was determined to be medically significant.
Age: 1.0
Sex: M
Vaccine: HEP, MMR, PNC, VARCEL
Symptoms: Dermatitis, Generalised tonic-clonic seizure, Hyperglycaemia, Pyrexia, Rash
Clinical narrative: hyperglycemia; generalized tonic/clonic seizure; fever; rash; chickenpox; Information has been downloaded from Regulatory Authority (HQ1748807JUN2001).  This spontaneous report was received from an other health professional referring to a 12-month-old male patient. No information was provided regarding the patient's medical history, concurrent conditions, drug and allergy history or concomitant medications.  On 06-APR-2001, the patient was vaccinated with varicella virus vaccine live (oka/merck)(VARIVAX), 1 dosage form, subcutaneously (lot# and expiration date were not provided).  On the same date, the patient also received measles, mumps, and rubella (wistar ra 27-3) virus vaccine, live (M-M-R II) (HSA), lot# reported as 1308K (Lot No. 1308K has been verified to be a valid lot number for measles, mumps, and rubella (wistar ra 27-3) virus vaccine, live, expiration date not reported, but upon internal validation established as 09-JUN-2002), 1 dosage form, subcutaneously, hepatitis b vaccine (recombinant)(RECOMBIVAX HB) intramuscularly, lot# reported as 1823K (Lot number 1823K is an invalid lot number for hepatitis b vaccine (recombinant)), 1 dosage form, and pneumococcal 4 6b 9v 14 18c 19f 23f conj vaccine (crm197)(PREVNAR) 1 dosage form, intramuscularly, lot#  reported as 472-553 (expiration date was not provided). The indications for all the suspect therapies was immunization.  On 16-APR-2001, the patient experienced generalised tonic-clonic seizure, chickenpox (Varicella), rash (dermatitis) and fever (pyrexia).  On an unknown date, the patient experienced hyperglycaemia.      At the reporting time, the outcome of generalised tonic-clonic seizure, hyperglycaemia, varicella, dermatitis and pyrexia was unknown. The causal relationship between the events and varicella virus vaccine live (oka/merck)(VARIVAX), measles, mumps, and rubella (wistar ra 27-3) virus vaccine, live (M-M-R II), hepatitis b vaccine (recombinant)(RECOMBIVAX HB) and pneumococcal 4 6b 9v 14 18c 19f 23f conj vaccine (crm197)(PREVNAR) was not provided.  The agency considered the events generalised tonic-clonic seizure, varicela, dermatitis and pyrexia and hyperglycaemia to be medically significant.  This is a new safety report and has been created due to safety report "US-009507513-2007USA002551"  having been submitted with an incorrect WWID reference "HQ1748807JUN2001" that does not refer to an existing case. "US-009507513-2007USA002551" will be nullified. The correct WWID " US-009507513-2007USA010609"  is referenced within this safety report and will be kept as the master case file.
Age: 1.0
Sex: M
Vaccine: HEP, MMR, PNC, VARCEL
Symptoms: Varicella
Clinical narrative: hyperglycemia; generalized tonic/clonic seizure; fever; rash; chickenpox; Information has been downloaded from Regulatory Authority (HQ1748807JUN2001).  This spontaneous report was received from an other health professional referring to a 12-month-old male patient. No information was provided regarding the patient's medical history, concurrent conditions, drug and allergy history or concomitant medications.  On 06-APR-2001, the patient was vaccinated with varicella virus vaccine live (oka/merck)(VARIVAX), 1 dosage form, subcutaneously (lot# and expiration date were not provided).  On the same date, the patient also received measles, mumps, and rubella (wistar ra 27-3) virus vaccine, live (M-M-R II) (HSA), lot# reported as 1308K (Lot No. 1308K has been verified to be a valid lot number for measles, mumps, and rubella (wistar ra 27-3) virus vaccine, live, expiration date not reported, but upon internal validation established as 09-JUN-2002), 1 dosage form, subcutaneously, hepatitis b vaccine (recombinant)(RECOMBIVAX HB) intramuscularly, lot# reported as 1823K (Lot number 1823K is an invalid lot number for hepatitis b vaccine (recombinant)), 1 dosage form, and pneumococcal 4 6b 9v 14 18c 19f 23f conj vaccine (crm197)(PREVNAR) 1 dosage form, intramuscularly, lot#  reported as 472-553 (expiration date was not provided). The indications for all the suspect therapies was immunization.  On 16-APR-2001, the patient experienced generalised tonic-clonic seizure, chickenpox (Varicella), rash (dermatitis) and fever (pyrexia).  On an unknown date, the patient experienced hyperglycaemia.      At the reporting time, the outcome of generalised tonic-clonic seizure, hyperglycaemia, varicella, dermatitis and pyrexia was unknown. The causal relationship between the events and varicella virus vaccine live (oka/merck)(VARIVAX), measles, mumps, and rubella (wistar ra 27-3) virus vaccine, live (M-M-R II), hepatitis b vaccine (recombinant)(RECOMBIVAX HB) and pneumococcal 4 6b 9v 14 18c 19f 23f conj vaccine (crm197)(PREVNAR) was not provided.  The agency considered the events generalised tonic-clonic seizure, varicela, dermatitis and pyrexia and hyperglycaemia to be medically significant.  This is a new safety report and has been created due to safety report "US-009507513-2007USA002551"  having been submitted with an incorrect WWID reference "HQ1748807JUN2001" that does not refer to an existing case. "US-009507513-2007USA002551" will be nullified. The correct WWID " US-009507513-2007USA010609"  is referenced within this safety report and will be kept as the master case file.
Age: 70.0
Sex: M
Vaccine: VARZOS
Symptoms: Arthralgia, Fatigue
Clinical narrative: tiredness; hand and foot joints are aching; This case was reported by a consumer via call center representative and described the occurrence of tiredness in a 71-year-old male patient who received Herpes zoster (Shingrix) for prophylaxis.   On 21st July 2020, the patient received the 2nd dose of Shingrix. In July 2020, less than a day after receiving Shingrix, the patient experienced tiredness and arthralgia multiple. On an unknown date, the outcome of the tiredness and arthralgia multiple were not recovered/not resolved.   It was unknown if the reporter considered the tiredness and arthralgia multiple to be related to Shingrix.  Additional details were provided as follows: The patient received 2nd dose 24 hours ago and patient's hand and foot joints were aching after receiving 2nd Shingrix shot. The patient asked if this to be expected and how long it would remain and asked if these achy joints (hands especially) and tiredness were normal side effects. The patient wanted to know if most of people felt achiness and if these would remain more than a day.
Sex: U
Vaccine: VARZOS
Symptoms: Adverse drug reaction
Clinical narrative: Side effects; This case was reported by a consumer via interactive digital media and described the occurrence of adverse drug reaction in a adult patient who received Herpes zoster (Shingrix) for prophylaxis.   On 21st July 2020 16:00, the patient received the 2nd dose of Shingrix. In July 2020, less than a week after receiving Shingrix, the patient experienced adverse drug reaction. On an unknown date, the outcome of the adverse drug reaction was not recovered/not resolved.   It was unknown if the reporter considered the adverse drug reaction to be related to Shingrix.  Additional details were reported as follows: The age at vaccination was not reported. The age group was not reported but was selected as an adult as per vaccine indication. The patient received Shingrix and experienced most of the side effects listed but not severely. The patient asked how long the side effects lasts.; Sender's Comments:  US-GLAXOSMITHKLINE-US2020AMR133646:same reporter
Age: 66.0
Sex: F
Vaccine: VARZOS
Symptoms: Dehydration, Headache, Inappropriate schedule of product administration, Pain in extremity, Social problem
Clinical narrative: headache; dehydration due to not drinking enough fluids; first Sept 2019 and second dose on July 22, 2020 due to Covid-19; sore arm; This case was reported by a consumer via call center representative and described the occurrence of pain in arm in a 66-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included Shingrix with an associated reaction of pain in extremity (1st dose received on 3rd September 2019, refer case US2020140202).   On 22nd July 2020, the patient received the 2nd dose of Shingrix (intramuscular). On 22nd July 2020, less than a day after receiving Shingrix, the patient experienced pain in arm and social problem. On 23rd July 2020, the patient experienced headache and dehydration. The patient was treated with paracetamol (Tylenol). On an unknown date, the outcome of the pain in arm was recovering/resolving and the outcome of the headache, dehydration and social problem were unknown.   It was unknown if the reporter considered the pain in arm, headache and dehydration to be related to Shingrix.  Additional information was provided as follows: The patient received 2nd dose later than the receommended interval due to COVID 19. The patient developed sore arm a few hours after dose, and sore arm was getting better. The patient woke up with a headache next morning and believed this was caused from dehydration due to not drinking enough fluids last night to support potential dehydration hypothesis, caller reported usually waking up in middle of night to use bathroom but did not last night. The patietn took Tylenol for headache. The reporter did not consent to follow up.; Sender's Comments:  US-GLAXOSMITHKLINE-US2020140202:first dose
Age: 0.5
Sex: F
Vaccine: DTAPIPVHIB
Symptoms: Hyperhidrosis, Injection site induration, Injection site pain, Injection site swelling, Injection site warmth
Clinical narrative: this is my daughter's 3rd series of the pentacel, she developed fever x48 hrs,diaphoretic non stop, swelling to site, hardness on injection site, (not getting any better) even after massaging, tenderness, hot to the touch, restlessness and not sleeping through the night. Patient did not have an adverse reaction to the first two.
Age: 0.5
Sex: F
Vaccine: DTAPIPVHIB
Symptoms: Insomnia, Pyrexia, Restlessness
Clinical narrative: this is my daughter's 3rd series of the pentacel, she developed fever x48 hrs,diaphoretic non stop, swelling to site, hardness on injection site, (not getting any better) even after massaging, tenderness, hot to the touch, restlessness and not sleeping through the night. Patient did not have an adverse reaction to the first two.
Age: 19.0
Sex: F
Vaccine: MENB
Symptoms: Coordination abnormal, Dizziness, Fatigue, Feeling abnormal, Headache
Clinical narrative: loss of consciousness; tunnel vision; convulsing with arm and head; She felt like she lost control/ Loss of control; arm went numb; tingling from shoulder to wrist, across chest and head; felt nauseous; felt dizzy; headache; felt foggy; seeing bright lights; shaking, patient reported it to them as "seizure like"; felt tired; This case was reported by a other health professional via sales rep and described the occurrence of loss of consciousness in a 19-year-old female patient who received Men B NVS (Bexsero) (batch number ABXA94AA, expiry date 28th February 2022) for prophylaxis.   Previously administered products included Bexsero (received 1st dose on unknown date).   On 22nd July 2020, the patient received the 2nd dose of Bexsero .5 ml. On 22nd July 2020, less than a day after receiving Bexsero, the patient experienced loss of consciousness (serious criteria GSK medically significant), tunnel vision (serious criteria GSK medically significant), convulsion (serious criteria GSK medically significant), coordination abnormal, numbness of upper extremities, tingling, nausea, dizziness, headache, foggy feeling in head, abnormal vision, tremor and tiredness. On an unknown date, the outcome of the loss of consciousness, tunnel vision, convulsion, coordination abnormal, numbness of upper extremities, tingling, nausea, dizziness, headache, foggy feeling in head, abnormal vision, tremor and tiredness were unknown.   It was unknown if the reporter considered the loss of consciousness, tunnel vision, convulsion, coordination abnormal, numbness of upper extremities, tingling, nausea, dizziness, headache, foggy feeling in head, abnormal vision, tremor and tiredness to be related to Bexsero.  Additional details were reported as follows: The patient got her second dose of Bexsero, she drove home, and then 2 hours post visit her arm went numb, tingling from shoulder to wrist, across chest and head. She developed tunnel vision, loss of consciousness, felt nauseous, dizzy, had a headache, felt foggy, was seeing bright lights, shaking, patient reported it to them as seizure like, she felt like she lost control. Her friend reported her convulsing with arm and head. The patient felt very tired afterwards. He brought her in later that night and she felt better.
Age: 19.0
Sex: F
Vaccine: MENB
Symptoms: Hypoaesthesia, Loss of consciousness, Nausea, Paraesthesia, Seizure
Clinical narrative: loss of consciousness; tunnel vision; convulsing with arm and head; She felt like she lost control/ Loss of control; arm went numb; tingling from shoulder to wrist, across chest and head; felt nauseous; felt dizzy; headache; felt foggy; seeing bright lights; shaking, patient reported it to them as "seizure like"; felt tired; This case was reported by a other health professional via sales rep and described the occurrence of loss of consciousness in a 19-year-old female patient who received Men B NVS (Bexsero) (batch number ABXA94AA, expiry date 28th February 2022) for prophylaxis.   Previously administered products included Bexsero (received 1st dose on unknown date).   On 22nd July 2020, the patient received the 2nd dose of Bexsero .5 ml. On 22nd July 2020, less than a day after receiving Bexsero, the patient experienced loss of consciousness (serious criteria GSK medically significant), tunnel vision (serious criteria GSK medically significant), convulsion (serious criteria GSK medically significant), coordination abnormal, numbness of upper extremities, tingling, nausea, dizziness, headache, foggy feeling in head, abnormal vision, tremor and tiredness. On an unknown date, the outcome of the loss of consciousness, tunnel vision, convulsion, coordination abnormal, numbness of upper extremities, tingling, nausea, dizziness, headache, foggy feeling in head, abnormal vision, tremor and tiredness were unknown.   It was unknown if the reporter considered the loss of consciousness, tunnel vision, convulsion, coordination abnormal, numbness of upper extremities, tingling, nausea, dizziness, headache, foggy feeling in head, abnormal vision, tremor and tiredness to be related to Bexsero.  Additional details were reported as follows: The patient got her second dose of Bexsero, she drove home, and then 2 hours post visit her arm went numb, tingling from shoulder to wrist, across chest and head. She developed tunnel vision, loss of consciousness, felt nauseous, dizzy, had a headache, felt foggy, was seeing bright lights, shaking, patient reported it to them as seizure like, she felt like she lost control. Her friend reported her convulsing with arm and head. The patient felt very tired afterwards. He brought her in later that night and she felt better.
Age: 19.0
Sex: F
Vaccine: MENB
Symptoms: Tremor, Tunnel vision, Visual impairment
Clinical narrative: loss of consciousness; tunnel vision; convulsing with arm and head; She felt like she lost control/ Loss of control; arm went numb; tingling from shoulder to wrist, across chest and head; felt nauseous; felt dizzy; headache; felt foggy; seeing bright lights; shaking, patient reported it to them as "seizure like"; felt tired; This case was reported by a other health professional via sales rep and described the occurrence of loss of consciousness in a 19-year-old female patient who received Men B NVS (Bexsero) (batch number ABXA94AA, expiry date 28th February 2022) for prophylaxis.   Previously administered products included Bexsero (received 1st dose on unknown date).   On 22nd July 2020, the patient received the 2nd dose of Bexsero .5 ml. On 22nd July 2020, less than a day after receiving Bexsero, the patient experienced loss of consciousness (serious criteria GSK medically significant), tunnel vision (serious criteria GSK medically significant), convulsion (serious criteria GSK medically significant), coordination abnormal, numbness of upper extremities, tingling, nausea, dizziness, headache, foggy feeling in head, abnormal vision, tremor and tiredness. On an unknown date, the outcome of the loss of consciousness, tunnel vision, convulsion, coordination abnormal, numbness of upper extremities, tingling, nausea, dizziness, headache, foggy feeling in head, abnormal vision, tremor and tiredness were unknown.   It was unknown if the reporter considered the loss of consciousness, tunnel vision, convulsion, coordination abnormal, numbness of upper extremities, tingling, nausea, dizziness, headache, foggy feeling in head, abnormal vision, tremor and tiredness to be related to Bexsero.  Additional details were reported as follows: The patient got her second dose of Bexsero, she drove home, and then 2 hours post visit her arm went numb, tingling from shoulder to wrist, across chest and head. She developed tunnel vision, loss of consciousness, felt nauseous, dizzy, had a headache, felt foggy, was seeing bright lights, shaking, patient reported it to them as seizure like, she felt like she lost control. Her friend reported her convulsing with arm and head. The patient felt very tired afterwards. He brought her in later that night and she felt better.
Age: 15.0
Sex: F
Vaccine: HPV9
Symptoms: Infertility female
Clinical narrative: I struggled with infertility for over 1 year and needed medical interventions to get pregnant
Age: 58.0
Sex: M
Vaccine: VARZOS
Symptoms: Pain in extremity
Clinical narrative: sore arm; This case was reported by a consumer via call center representative and described the occurrence of pain in arm in a 58-year-old male patient who received Herpes zoster (Shingrix) for prophylaxis.   In March 2020, the patient received the 1st dose of Shingrix. On an unknown date, less than 4 months after receiving Shingrix, the patient experienced pain in arm. On an unknown date, the outcome of the pain in arm was not recovered/not resolved.   The reporter considered the pain in arm to be related to Shingrix.  Additional details were reported as follows: The patient received Shingrix and no side effects other than a sore arm.   The reporter consented to follow up. For tolerances of 2nd dose, refer case US2020140274, reported by same reporter for the same patient.; Sender's Comments:  US-GLAXOSMITHKLINE-US2020140274:same reporter
Age: 11.0
Sex: F
Vaccine: HPV9
Symptoms: Swelling face, Urticaria
Clinical narrative: hives, facial swelling
Sex: U
Vaccine: FLUX
Symptoms: Influenza, Vaccination failure
Clinical narrative: Suspected vaccination failure/ influenza three times. First time was when I had a flu shot; influenza three times. First time was when I had a flu shot; This case was reported by a consumer via interactive digital media and described the occurrence of suspected vaccination failure in a patient who received Flu Seasonal QIV Dresden (Influenza vaccine Quadrivalent unspecified season) for prophylaxis.   The patient's past medical history included rubella, mumps and chickenpox.   On an unknown date, the patient received the 1st dose of Influenza vaccine Quadrivalent unspecified season. On an unknown date, unknown after receiving Influenza vaccine Quadrivalent unspecified season, the patient experienced vaccination failure (serious criteria GSK medically significant) and influenza. On an unknown date, the outcome of the vaccination failure was unknown and the outcome of the influenza was recovered/resolved.   It was unknown if the reporter considered the vaccination failure and influenza to be related to Influenza vaccine Quadrivalent unspecified season.  Additional details were reported as follows: The patient's demographics were not reported. The patient stated that he/she had rubella, mumps and chicken pox. No vaccines were received. The patient also had influenza three times. The patient had 1st time influenza when he/she received flu shot and it too months to get over. The last two no flu shot was over in about a week. The patient not had it in a few years. No other information was reported. This case was considered as suspected vaccination failure as details regarding vaccination schedule, time to onset for target disease and laboratory confirmation were unknown at the time of reporting.
Age: 81.0
Sex: F
Vaccine: VARZOS
Symptoms: Pulpitis dental, Toothache
Clinical narrative: Patient said she had tooth pain and inflamation. She made an appointment with her dentist, but by the time she was seen by her dentist, the inflamation had resolved. The patient's dentist informed her that he had two other cases in the previous 2 weeks besides her who had the same complaint after receiving the Shingrix vaccine.
Age: 70.0
Sex: F
Vaccine: VARZOS
Symptoms: Chills, Headache, Injection site pain, Injection site swelling, Injection site warmth
Clinical narrative: Fever, chills, headache and aching all over.  Site of Injection is swollen, extremely hot to the touch and sore. Beginning taking Benadryl per GP instruction given today (7/30/2020) and will ice intermediately.
Age: 70.0
Sex: F
Vaccine: VARZOS
Symptoms: Pain, Pyrexia
Clinical narrative: Fever, chills, headache and aching all over.  Site of Injection is swollen, extremely hot to the touch and sore. Beginning taking Benadryl per GP instruction given today (7/30/2020) and will ice intermediately.
Age: 56.0
Sex: M
Vaccine: VARZOS
Symptoms: Asthenia, Fatigue, Injection site pain, Myalgia
Clinical narrative: Tired, weak, mild muscle ache (besides significant pain at site of injection). So far lasting >1 day
Age: 36.0
Sex: M
Vaccine: HEPAB
Symptoms: Inappropriate schedule of product administration
Clinical narrative: Delay in receipt of 2nd dose was due to pandemic COVID-19; This case was reported by a nurse via call center representative and described the occurrence of drug dose administration interval too long in a male patient who received HAB (Twinrix) for prophylaxis.   Previously administered products included Twinrix (received 1st dose 5 months ago from 2nd dose).   On an unknown date, the patient received the 2nd dose of Twinrix. On an unknown date, unknown after receiving Twinrix, the patient experienced drug dose administration interval too long. On an unknown date, the outcome of the drug dose administration interval too long was unknown.  Additional details were reported as follows: The age at vaccination was not reported. The patient had been administered with Twinrix vaccine on month 0 and the second dose had been given 5 months later.  The reporter asked regarding of how to proceed on the 3rd dose. The patient received 2nd dose of Twinrix, later than the recommended interval, which led to lengthtening of vaccination schedule. The reporter consented to follow up.   Follow-up information received from nurse on 23rd April 2020 : The patient's demographics were updated. On 18th February 2020, the patient received 1st dose, intramuscularly, from batch 75C72 with expiry date 13th June 2022. On 10th July 2020, the patient received 2nd dose, intramuscularly, from batch 9RT94 with expiry date 24th May 2022. The patient received 2nd dose of vaccine late because of pandemic covid 19 situation. The physicina waiting recipient to meet face to face. Third dose was planned 5 months from 2nd dose administration as per CSC guidelines. The VAERS details were updated.
Age: 51.0
Sex: F
Vaccine: VARZOS
Symptoms: Erythema, Induration, Swelling
Clinical narrative: Red area, induration, localized swelling
Age: 59.0
Sex: M
Vaccine: VARZOS, VARZOS
Symptoms: Extra dose administered, Headache, Inappropriate schedule of product administration, Injection site erythema, Injection site pain
Clinical narrative: Redness at Injection Site; soreness at the injection site; Soreness to Kidneys; Sharp Stabbing Pain in his Head/Headache; body aches/stabbing pain; had a third dose of Shingrix on July 13th; first dose of Shingrix in 2018 / second dose of Shingrix on July 25th 2019; This case was reported by a consumer via call center representative and described the occurrence of injection site erythema in a 60-year-old male patient who received Herpes zoster (Shingrix) for prophylaxis.   Co-suspect products included Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included Shingrix (received 1st dose in 2018).   On 13th July 2020, the patient received the 3rd dose of Shingrix. On 25th July 2019, the patient received the 2nd dose of Shingrix. In July 2019, not applicable after receiving Shingrix and unknown after receiving Shingrix, the patient experienced drug dose administration interval too long. In July 2020, the patient experienced injection site erythema, injection site pain, renal pain, headache, general body pain and extra dose administered. On an unknown date, the outcome of the injection site erythema, injection site pain, renal pain and headache were recovered/resolved and the outcome of the general body pain, extra dose administered and drug dose administration interval too long were unknown.   It was unknown if the reporter considered the injection site erythema, injection site pain, renal pain, headache and general body pain to be related to Shingrix.  Additional details were reported as follows: The patient received 3rd dose of Shingrix, which led to extra dose administered and had redness and soreness at the injection site, along with soreness to his kidneys, and a sharp, stabbing pain in his head and body aches.  The reporter wanted to know if he would had any effects from taking a third dose of Shingrix.   The patient provided a Medical Disclaimer for the caller and information from the PI and content and provided the caller with the MI number to give to his HCP to have him call our MI department.   The did not know why he waited to have his second dose of Shingrix, which led to lengthening of vaccination schedule. The reporter consented to follow up.
Age: 59.0
Sex: M
Vaccine: VARZOS, VARZOS
Symptoms: Pain, Renal pain
Clinical narrative: Redness at Injection Site; soreness at the injection site; Soreness to Kidneys; Sharp Stabbing Pain in his Head/Headache; body aches/stabbing pain; had a third dose of Shingrix on July 13th; first dose of Shingrix in 2018 / second dose of Shingrix on July 25th 2019; This case was reported by a consumer via call center representative and described the occurrence of injection site erythema in a 60-year-old male patient who received Herpes zoster (Shingrix) for prophylaxis.   Co-suspect products included Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included Shingrix (received 1st dose in 2018).   On 13th July 2020, the patient received the 3rd dose of Shingrix. On 25th July 2019, the patient received the 2nd dose of Shingrix. In July 2019, not applicable after receiving Shingrix and unknown after receiving Shingrix, the patient experienced drug dose administration interval too long. In July 2020, the patient experienced injection site erythema, injection site pain, renal pain, headache, general body pain and extra dose administered. On an unknown date, the outcome of the injection site erythema, injection site pain, renal pain and headache were recovered/resolved and the outcome of the general body pain, extra dose administered and drug dose administration interval too long were unknown.   It was unknown if the reporter considered the injection site erythema, injection site pain, renal pain, headache and general body pain to be related to Shingrix.  Additional details were reported as follows: The patient received 3rd dose of Shingrix, which led to extra dose administered and had redness and soreness at the injection site, along with soreness to his kidneys, and a sharp, stabbing pain in his head and body aches.  The reporter wanted to know if he would had any effects from taking a third dose of Shingrix.   The patient provided a Medical Disclaimer for the caller and information from the PI and content and provided the caller with the MI number to give to his HCP to have him call our MI department.   The did not know why he waited to have his second dose of Shingrix, which led to lengthening of vaccination schedule. The reporter consented to follow up.
Age: 59.0
Sex: F
Vaccine: VARZOS
Symptoms: Arthralgia, Chills, Myalgia, Pyrexia
Clinical narrative: Generalized muscle and joint pain, fever, chills for two days
Age: 67.0
Sex: F
Vaccine: VARZOS
Symptoms: Herpes zoster
Clinical narrative: shingles; This case was reported by a pharmacist via call center representative and described the occurrence of shingles in a 67-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   On 11th February 2020, the patient received the 1st dose of Shingrix. On an unknown date, less than 6 months after receiving Shingrix, the patient experienced shingles. On an unknown date, the outcome of the shingles was unknown.   It was unknown if the reporter considered the shingles to be related to Shingrix.  Additional details were reported as follows: The patient received Shingrix and developed shingles. No vaccines data was provided. The reporter consented to follow up.
Age: 16.0
Sex: F
Vaccine: MNQ
Symptoms: Dizziness
Clinical narrative: Patient awoke in the morning, took a shower and became very dizzy to the point she felt she was going to faint. She laid down and was given some juice. She continued to feel dizzy throughout the day, symptoms did ease slightly.
Age: 52.0
Sex: F
Vaccine: VARZOS
Symptoms: Bone pain, Diarrhoea, Dizziness, Fatigue, Feeding disorder
Clinical narrative: Severe headache, severe nausea to almost vomiting, severe diarrhea, inability to eat, exhaustion, dizziness/lightheadedness, inability to lie on or touch the injection site (right upper arm), fever up to 103 for extended period of time, fever over 101 for 2+ days now, body and bone aches and pain.
Age: 52.0
Sex: F
Vaccine: VARZOS
Symptoms: Headache, Injection site pain, Nausea, Pain, Pyrexia
Clinical narrative: Severe headache, severe nausea to almost vomiting, severe diarrhea, inability to eat, exhaustion, dizziness/lightheadedness, inability to lie on or touch the injection site (right upper arm), fever up to 103 for extended period of time, fever over 101 for 2+ days now, body and bone aches and pain.
Age: 68.0
Sex: M
Vaccine: VARZOS
Symptoms: Fatigue, Feeling hot, Headache, Pain, Pain in extremity
Clinical narrative: achy; feverish; headache; fatigue; warm body; soreness in the arm; This case was reported by a consumer via call center representative and described the occurrence of pain in a 68-year-old male patient who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included Shingrix with an associated reaction of pain in extremity (1st dose received either the 10th or the 15th of March 2020, please refer the case US2020AMR140069).   On 21st July 2020, the patient received the 2nd dose of Shingrix. In July 2020, 12 hrs after receiving Shingrix, the patient experienced pain, fever, headache, fatigue, feeling of warmth and pain in arm. Rechallenge with Shingrix was positive. On an unknown date, the outcome of the pain, fever, headache, fatigue, feeling of warmth and pain in arm were not recovered/not resolved.   It was unknown if the reporter considered the pain, fever, headache, fatigue, feeling of warmth and pain in arm to be related to Shingrix.  Additional case details were reported as follows: The patient received the 2nd dose at 4:00 pm. The patient experienced same soreness in the arm. All symptoms presented approximately 12 hours following the administration of that dose. The reporter consent to follow up.; Sender's Comments:  US-GLAXOSMITHKLINE-US2020AMR140069:1st dose
Age: 68.0
Sex: M
Vaccine: VARZOS
Symptoms: Pyrexia
Clinical narrative: achy; feverish; headache; fatigue; warm body; soreness in the arm; This case was reported by a consumer via call center representative and described the occurrence of pain in a 68-year-old male patient who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included Shingrix with an associated reaction of pain in extremity (1st dose received either the 10th or the 15th of March 2020, please refer the case US2020AMR140069).   On 21st July 2020, the patient received the 2nd dose of Shingrix. In July 2020, 12 hrs after receiving Shingrix, the patient experienced pain, fever, headache, fatigue, feeling of warmth and pain in arm. Rechallenge with Shingrix was positive. On an unknown date, the outcome of the pain, fever, headache, fatigue, feeling of warmth and pain in arm were not recovered/not resolved.   It was unknown if the reporter considered the pain, fever, headache, fatigue, feeling of warmth and pain in arm to be related to Shingrix.  Additional case details were reported as follows: The patient received the 2nd dose at 4:00 pm. The patient experienced same soreness in the arm. All symptoms presented approximately 12 hours following the administration of that dose. The reporter consent to follow up.; Sender's Comments:  US-GLAXOSMITHKLINE-US2020AMR140069:1st dose
Age: 1.0
Sex: F
Vaccine: DTAPIPVHIB, HEPA, MMRV, PNC13, VARCEL
Symptoms: Extra dose administered, No adverse event, Wrong product administered
Clinical narrative: patient in office for 12 month WCE. patient  record showed patient due for MMR, Varivax, DTaP, Hib, Hep A and PCV13 . Medical assistant working in office mistakened MMR with MMRV, there for the patient received a double dose of varicella. patient received both varivax and mmrv in same day.  no adverse reaction at this time. family notified with instruction and home care advise.
Sex: F
Vaccine: TDAP
Symptoms: Halo vision, Visual impairment
Clinical narrative: Vision changes; Seeing halos in left eye; This case was reported by a consumer via call center representative and described the occurrence of visual disturbance in a female patient who received DTPa (Reduced antigen) (Boostrix) (batch number 49R79, expiry date 2nd April 2022) for prophylaxis.   On 25th June 2020, the patient received Boostrix (intramuscular) .5 ml. On 25th June 2020, less than a day after receiving Boostrix, the patient experienced visual disturbance and vision halo. On an unknown date, the outcome of the visual disturbance and vision halo were not recovered/not resolved.   It was unknown if the reporter considered the visual disturbance and vision halo to be related to Boostrix.  Additional details were reported as follows: The age at vaccination was not reported. The patient received the Boostrix (Tdap) vaccine and she stated that within hours of receiving the vaccination, she began to have visual changes. She reported about seeing halos in her left eye.  This symptom s had not cleared up. The reporter did not consent to follow up.
Age: 17.0
Sex: F
Vaccine: MENB
Symptoms: Visual impairment
Clinical narrative: Father called within 2 hours after vaccine was given, complained of the daughter "cant see".  Sent them to ER and I called the father today (the next day) and he said by the time they were seen at the ER, her vision improved and by the time they were home, she was back to normal.   Apparently Dad said no treatment was done in the ER.  I still have to get hold of the ER and get their records.  In the meantime, I got hold of a local Infectious Disease Physician and he have not seen something like this.  I also got hold of GSK medical staff and mentioned one report similar to this and have not known of this kind of event after Bexero.    Talked to the father this morning and he said, the daughther is back to normal and was grateful I checked on her daughter.
Age: 57.0
Sex: F
Vaccine: VARZOS
Symptoms: Rash
Clinical narrative: abdominal Rash; This case was reported by a consumer via call center representative and described the occurrence of rash in a 57-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included Shingrix (received 1st dose in September 2018).   In February 2019, the patient received the 2nd dose of Shingrix. In August 2019, between 5 and 7 months after receiving Shingrix, the patient experienced rash. The patient was treated with valaciclovir hydrochloride (Valtrex) and prednisone. On an unknown date, the outcome of the rash was resolved with sequelae.   It was unknown if the reporter considered the rash to be related to Shingrix.  Additional details were reported as follows: The patient reported that following the vaccinations in August2019, she developed an abdominal rash and went to the emergency room. She was prescribed prednisone and valtrex and the rash resolved several days later. Time passed and in April 2020, she developed similar abdominal rash, again visited the emergency room and was prescribed prednisone and valtrex, and the rash resolved. Her most recent outbreak was in July 2020, She visited her healthcare professional, who scheduled an appointment for her to see a dermatologist. No hospitalizations occurred for any of the visits. The reporter consented to follow up.
Age: 55.0
Sex: F
Vaccine: VARZOS
Symptoms: Lymphadenitis
Clinical narrative: Lymphadenitis in armpit of same side as injection site, no treatment necessary, patient doing well
Sex: M
Vaccine: VARZOS
Symptoms: Adverse drug reaction
Clinical narrative: all of the side effects; This case was reported by a consumer via call center representative and described the occurrence of adverse drug reaction in a adult 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 adverse drug reaction. On an unknown date, the outcome of the adverse drug reaction was unknown.   It was unknown if the reporter considered the adverse drug reaction to be related to Shingrix.  Additional details were provided as follows: The age at vaccination was not reported. The patient experienced all the side effects from Shingrix except for fever.  The reporter did not consent to follow-up.