chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 75.0
Sex: M
Vaccine: PPV
Symptoms: Injection site erythema, Injection site pain, Injection site pruritus, Injection site swelling
Clinical narrative: The patient reported "significant" pain, swelling, redness, and itching around the injection site.; The patient reported "significant" pain, swelling, redness, and itching around the injection site.; The patient reported "significant" pain, swelling, redness, and itching around the injection site.; The patient reported "significant" pain, swelling, redness, and itching around the injection site.; This spontaneous report was received from a pharmacist and refers to a 75-year-old male patient. No information regarding the patient's concurrent conditions, medical history, drug reactions or allergies and concomitant medications was provided.  On 29-JUL-2020, the patient was vaccinated with pneumococcal vaccine, polyvalent (23-valent) (PNEUMOVAX23) 0.5 ml injection (lot#, expiration date, route and site of administration were not provided) for prophylaxis.  On 30-JUL-2020 (reported as "the next day"), he experienced "significant" pain, swelling, redness, and itching around the injection site. He reported the swelling was significant enough that it could be seen. The outcome of the aforementioned events was unknown.  The relatedness between the events and pneumococcal vaccine, polyvalent (23-valent) (PNEUMOVAX23) was not provided.  This is one of several reports received from the same reporter. 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:; deviceage and unit: 0 ; malfunction: Unknown; deviceusage: Initial; evaluatedbymfr: Not returned to manufacturer; reasonfornoneval: 81 Other; labeledsingleusedevice: No; mdcpreportability: No; mdcpreprationale: Case information does not suggest a causal association with the device or device constituent; Sender's Comments:  US-009507513-2008USA001082: US-009507513-2008USA001325:
Sex: U
Vaccine: MMR, VARCEL
Symptoms: No adverse event, Product storage error
Clinical narrative: improperly stored temperature excursion; This spontaneous report was received from a physician and refers to a patient of unknown age and gender. There was no information about the patient's concurrent conditions, concomitant therapies or medical history provided.  On 04-AUG-2020, the patient was vaccinated with an improperly stored dose of measles, mumps, and rubella (wistar ra 27-3) virus vaccine, live (recombinant human albumin) (M-M-R II) dose/frequency reported as 1 (units not provided), lot # S020160 was confirmed to be valid, expiration date 30-JUN-2021 (dose, route of administration and anatomical location were not reported) and improperly stored dose of varicella virus vaccine live (oka/merck) (VARIVAX) dose/frequency reported as 1 (units not provided), lot # S038175 was confirmed to be valid, expiration date 26-NOV-2021 (dose, route of administration and anatomical location were not reported) both for prophylaxis.  The administered doses of vaccines experienced the temperature excursion of - 6 degrees Fahrenheit (F) to 14 F (10 F) for 1 hour and 15 minutes, 15 F to 46 F (44.8 F) for 1 hour and 30 minutes and 47 F to 77 F (50 F) for 2 hours and 30 minutes. There were no previous excursions reported. Digital data logger was involved.
Age: 5.0
Sex: F
Vaccine: MMRV
Symptoms: No adverse event, Product storage error
Clinical narrative: No additional AE; Administered after temperature excursion; This spontaneous report was received from a nurse concerning a 5 years old female patient. The patient's concurrent condition, medical history and concomitant therapy were not reported.    On 10-AUG-2020, the patient was vaccinated with one dose of measles, mumps, rubella and varicella (oka-merck) virus vaccine live (PROQUAD) (lot # S022915, expiry date: 19-JAN-2021; dose, frequency and route were not reported) for prophylaxis since the excursion occurred (product storage error). The temperature was reported as -6.9 degrees Celsius (highest temperature). The time frame was reported as 1 hour and 15 minutes (total time out of range). No previous temperature excursion was reported. The call was because of a data logger. No additional adverse event (AE) was reported.
Sex: U
Vaccine: MMRV
Symptoms: No adverse event, Product storage error
Clinical narrative: No additional adverse effect reported; patient received improperly stored PROQUAD; This spontaneous report was received from a physician rand refers to a patient of unknown age or gender. Information regarding the patient's drug reactions or allergies, concomitant therapies and patient's pertinent medical history was not provided. On 29-JUL-2020, the patient received an improperly stored measles (+) mumps (+) rubella (+) varicella (oka-merck) virus vaccine live (rHA) (PROQUAD) injection, lot # S027466, expiry date 02-MAR-2021, for prophylaxis (concentration, dose, dose number, route of administration and frequency were not reported). The vaccine was reconstituted properly stored diluent. Digital data logger was involved. The measles (+) mumps (+) rubella (+) varicella (oka-merck) virus vaccine live (rHA) (PROQUAD) underwent a temperature excursion in the range of 47 degrees of Fahrenheit (F) to 77 F (66 F) for 3 days. There was no previous temperature excursion. No additional adverse effects were reported. No product quality complaint (PQC) was involved.
Sex: U
Vaccine: HPV4, HPV9, MNQ, UNK, UNK
Symptoms: No adverse event, Product storage error
Clinical narrative: no adverse effects; Product reported as GARDASIL but lot # valid for GARDASIL 9; unspecified number of unspecified patients have been administered doses of improperly stored vaccines; This non-valid spontaneous report as received from a nurse and refers to an unspecified number of patients of unknown age and gender. There was no information about the patients' concurrent conditions, concomitant therapies or medical histories provided.  On 10-MAR-2020, the patient was vaccinated with improperly stored doses of quadrivalent human papillomavirus (types 6,11,16,18) recomb. vaccine(GARDASIL),0.5 milliliter, intramuscular in the right arm for prophylaxis; meningococcal acyw conj vaccine (dip toxoid)(MENACTRA), diphtheria toxoid, pertussis acellular vaccine (unspecified), tetanus toxoid(DIPHTHERIA TOXOID (+) PERTUSSIS ACELLULAR VACCINE (UNSPECIFIED) (+) TETANUS TOXOID). Reporter reported quadrivalent human papillomavirus (types 6,11,16,18) recomb. vaccine(GARDASIL) with lot # 1621931 which was not valid for quadrivalent human papillomavirus (types 6,11,16,18) recomb. vaccine(GARDASIL). However, lot# 1621931, expiration date  26-JAN-2022 was valid for  hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast)(GARDASIL 9).No adverse event was reported.  This is one of several reports from the same reporter. 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: 1621931; expirationdate: 26-JAN-2022; 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; Sender's Comments:  US-009507513-2003USA002275:Original Case : 2003USA002275
Sex: U
Vaccine: DTAP, HIBV, PNC13
Symptoms: No adverse event, Product storage error
Clinical narrative: no adverse effects; unspecified number of unspecified patients have been administered doses of improperly stored vaccines; This spontaneous report as received from a registered nurse, referring to a patient (gender and age not reported).  No information regarding the patient's medical history, concurrent conditions or concomitant therapies was provided.  On 17-MAR-2020 at 09:53 hours, the patinet was vaccinated with an improperly stored dose of Haemophilus b Conjugate Vaccine (Meningococcal Protein Conjugate) (LIQUID PEDVAXHIB) with a valid lot # S023219 and expiration date on 03-MAR-2022 at a dose of 0.5 mL intramuscularly (IM) on the right tight (RT) and with an improperly stored dose of diphtheria toxoid, and an improperly stored dose of pneumococcal 13v conj vaccine (CRM197) dose of 0.5 mL intramuscularly (IM) on the left tight (LT) lot # AT8585; diphtheria toxoid, pertussis acellular vaccine (unspecified), tetanus toxoid dose of 0.5 mL intramuscularly (IM) on the left tight (LT) lot # J947T for prophylaxis, however no adverse effects reported.   Administered dose of Haemophilus b Conjugate Vaccine (Meningococcal Protein Conjugate) (LIQUID PEDVAXHIB) experienced the temperature excursion above 9 degrees Celsius (15.5C) for 4 hour and 6 minutes. Digital data logger was involved. There were no previous temperature excursions reported.  This is one of the several reports received from the same reporter.   This case comes from a case previously considered non-valid, but per new information received (patient identifiers) the case was splitted and determined to be valid for a specific patient.; Sender's Comments:  US-009507513-2008USA008876: US-009507513-2008USA008885: US-009507513-2008USA008889: US-009507513-2008USA008883: US-009507513-2008USA008884: US-009507513-2008USA008882: US-009507513-2003USA002275: US-009507513-2008USA008879: US-009507513-2008USA008880: US-009507513-2008USA008881: US-009507513-2008USA008875: US-009507513-2008USA008890: US-009507513-2008USA008877: US-009507513-2008USA008903: US-009507513-2008USA008913: US-009507513-2008USA008912: US-009507513-2008USA008931: US-009507513-2008USA008930: US-009507513-2008USA008901: US-009507513-2008USA008900: US-009507513-2008USA008899: US-009507513-2008USA008929: US-009507513-2008USA008928: US-009507513-2008USA008898: US-009507513-2008USA008927: US-009507513-2008USA008925: US-009507513-2008USA008896: US-009507513-2008USA008923: US-009507513-2008USA008911: US-009507513-2008USA008910: US-009507513-2008USA008922: US-009507513-2008USA008922: US-009507513-2008USA008887: US-009507513-2008USA008915: US-009507513-2008USA008916: US-009507513-2008USA008917: US-009507513-2008USA008906: US-009507513-2008USA008918: US-009507513-2008USA008919: US-009507513-2008USA008907: US-009507513-2008USA008909: US-009507513-2008USA008890: US-009507513-2008USA008932: US-009507513-2008USA008920: US-009507513-2008USA008904: US-009507513-2008USA008904: US-009507513-2008USA008886:
Sex: U
Vaccine: HEPA, HIBV, PPV, UNK
Symptoms: No adverse event, Product storage error
Clinical narrative: no adverse effects; unspecified number of unspecified patients have been administered doses of improperly stored vaccines; This spontaneous report as received from a registered nurse, referring to a patient (gender and age not reported).  No information regarding the patient's medical history, concurrent conditions or concomitant therapies was provided.  On 17-MAR-2020 at 13:52 hours, the patinet was vaccinated with an improperly stored dose of Haemophilus b Conjugate Vaccine (Meningococcal Protein Conjugate) (LIQUID PEDVAXHIB) with a valid lot # S023219 and expiration date on 03-MAR-2022 at a dose of 0.5 mL intramuscularly (IM) on the left tight (LT) and with an improperly stored dose of Hepatitis A Vaccine, Inactivated (VAQTA) at a dose of 0.5 mL intramuscularly (IM) on the right tight (RT) lot # reported as 747P5; an improperly stored dose of pneumococcal 13v conj vaccine (CRM197) dose of 0.5 mL intramuscularly (IM) on the left tight (LT) lot # AT8585; and a dose of diphtheria toxoid, pertussis acellular vaccine (unspecified), tetanus toxoidr prophylaxis, however no adverse effects reported.   Administered dose of Haemophilus b Conjugate Vaccine (Meningococcal Protein Conjugate) (LIQUID PEDVAXHIB) and Hepatitis A Vaccine, Inactivated (VAQTA) experienced the temperature excursion above 9 degrees Celsius (15.5C) for 4 hour and 6 minutes. Digital data logger was involved. There were no previous temperature excursions reported.  This is one of the several reports received from the same reporter.   This case comes from a case previously considered non-valid, but per new information received (patient identifiers) the case was splitted and determined to be valid for a specific patient.; Sender's Comments:  US-009507513-2008USA008876: US-009507513-2008USA008889: US-009507513-2008USA008883: US-009507513-2008USA008885: US-009507513-2008USA008884: US-009507513-2008USA008882: US-009507513-2003USA002275: US-009507513-2008USA008879: US-009507513-2008USA008886: US-009507513-2008USA008880: US-009507513-2008USA008881: US-009507513-2008USA008875: US-009507513-2008USA008890: US-009507513-2008USA008877: US-009507513-2008USA008903: US-009507513-2008USA008901: US-009507513-2008USA008913: US-009507513-2008USA008912: US-009507513-2008USA008931: US-009507513-2008USA008930: US-009507513-2008USA008900: US-009507513-2008USA008899: US-009507513-2008USA008929: US-009507513-2008USA008898: US-009507513-2008USA008927: US-009507513-2008USA008926: US-009507513-2008USA008925: US-009507513-2008USA008896: US-009507513-2008USA008923: US-009507513-2008USA008922: US-009507513-2008USA008921: US-009507513-2008USA008920: US-009507513-2008USA008890: US-009507513-2008USA008911: US-009507513-2008USA008910: US-009507513-2008USA008914: US-009507513-2008USA008887: US-009507513-2008USA008915: US-009507513-2008USA008916: US-009507513-2008USA008917: US-009507513-2008USA008906: US-009507513-2008USA008907: US-009507513-2008USA008909:
Age: 1.75
Sex: U
Vaccine: HEPA, UNK
Symptoms: Expired product administered, No adverse event
Clinical narrative: No additional adverse effects reported; one patient was administered a dose of expired but properly stored VAQTA; This spontaneous report was received from a medical assistant referring to a 21 months old patient of unknown gender. There was no information about the patient's concurrent conditions, drug reactions, allergies, medical history, and concomitant therapies provided.    On 12-AUG-2020, the patient was administered a dose of expired but properly stored hepatitis a vaccine, inactivated (VAQTA) (strength: 25/0.5 (units not provided), lot # S009562, expiration date was reported as 26-JUL-2020, but upon internal validation established as 05-MAY-2019) (exact dose and route of administration were not reported) for prophylaxis (expired vaccine used). No additional adverse effects. combinationproductreport: Yes; brandname: VAQTA SYRINGE (DEVICE); commondevicename: Hepatitis A Vaccine, Inactivated; productcode: FMF; devicetype: SYRINGE, PISTON (FMF); devicelotnumber: S009562; expirationdate: 05-MAY-2019; deviceage and unit: 0 ; malfunction: Unknown; deviceusage: Initial; 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: HPV9
Symptoms: Papilloma viral infection
Clinical narrative: received GARDASIL 9 and got HPV from the vaccine; This spontaneous report as received from a physician assistant via a company representative, refers to a female patient of unknown age. The patient's concurrent conditions, medical history and concomitant drugs were not reported.       On an unknown date, the patient was vaccinated with hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast) (GARDASIL 9) (exact dose, route of administration, anatomical location, lot # and expiration date were not reported) for prophylaxis.        On an unknown date, she experienced Human papilloma viral infection (HPV). It was unknown if the patient received any treatment or if any lab diagnostics or studies were performed. The outcome of the event was unknown.   The reporter considered the event to be related to hpv rL1 6 11 16 18 31 33 45 52 58 VLP vaccine (yeast) (GARDASIL 9) (reported as got HPV from the vaccine).
Sex: U
Vaccine: MMRV
Symptoms: Expired product administered
Clinical narrative: an expired PROQUAD was administered to a patient; This spontaneous report was received from a nurse referring to a patient of unknown age and gender. Information about medical history, concurrent conditions and concomitant therapies was not provided.       On 13-AUG-2020, the patient was vaccinated with expired measles, mumps, rubella and varicella (oka-merck) virus vaccine live (rHA (recombinant Human albumin)) (PROQUAD) (lot # S003862, expiration date 08-AUG-2020; strength, dose and route were not reported) for prophylaxis (expired product administered).  There were no previous temperature excursions.
Sex: U
Vaccine: MMR
Symptoms: Expired product administered, No adverse event
Clinical narrative: She reports the patient did not experience any adverse events; MMR II was expired then administered on 8/17/2020; This spontaneous report was received from a registered nurse concerning a patient of aproximately 16 years of unknown gender.   The patient's concurrent conditions, medical history, historical drug, drug reactions/allergies and concomitant therapies were not provided.  On 04-MAY-2005, the patient was vaccinated with the first dose of measles, mumps, and rubella (wistar ra 27-3) virus vaccine, live(M-M-R II); on 20-JUL-2009, the second dose was administered (dosage regimens, lot numbers and expiration dates were not provided) both for prophylaxis. The reporter informed that the patient second dose was given about 2 weeks to 1 month earlier (the patient was approximately 4 years which was still whithin the appropriate age range).    On 17-AUG-2020, the patient received the third dose of measles, mumps, and rubella (wistar ra 27-3) virus vaccine, live(M-M-R II)(recombinant human albumin, rHA), 0.5 milliliter, lot # R019684 has been verified to be valid and expiration date 09-JUL-2020 (expired vaccine used), for prophylaxis. (route of administration was not provided).   No temperature excursions were reported. The patient did not experience any adverse events.
Sex: U
Vaccine: VARCEL
Symptoms: No adverse event, Product storage error
Clinical narrative: No additional AE reported; Improperly stored then administered; This non-valid spontaneous report was received from an office manager and refers to two patients of unknown demographics. No information regarding the patients' medical history, concurrent condition, drug reaction or allergies and concomitant medication was provided.  On 17-AUG-2020, the patients received 2 improperly stored doses of varicella virus vaccine live (oka/merck)(VARIVAX), lot # S031497 was confirmed to be valid, expiration date 07-OCT-2021, (exact dose, route and site of administration were not provided) for prophylaxis. Administered doses of vaccine were exposed to the temperature of -13.7 degrees Celsius (C) for 4 minutes. There was no previous temperature excursion. The call was because of a digital data logger. There was no adverse event reported.   This report is non-valid due to lack of patients' identifiers.
Age: 12.0
Sex: M
Vaccine: HEPA
Symptoms: Incorrect dose administered, No adverse event
Clinical narrative: The patient did not experience any adverse event; pediatric patient got an adult dose ofVaqta/got 1 ml dose instead of 0.5 ml dose; This spontaneous report was received from a nurse and refers to a 12 year old male patient. No information was provided regarding the patient's medical history, concurrent conditions, previous drug reactions, allergies and concomitant medications.  On 19-AUG-2020, the patient was vaccinated with hepatitis a vaccine, inactivated (VAQTA) lot # S021449 expiration date 23-AUG-2020, at a dose of 1 mL (adult dose), instead of 0.5 mL dose, intramuscular in the left deltoid for hepatitis A immunization. The patient did not experience any adverse event.
Sex: U
Vaccine: VARZOS
Symptoms: Injection site erythema, Injection site swelling, Injection site warmth
Clinical narrative: Swelling, redness, and heat at injection site; Redness, and heat at injection site; Heat at injection site; This case was reported by a pharmacist via call center representative and described the occurrence of injection site swelling in an unspecified number of patients 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 injection site swelling, injection site erythema and injection site warmth. On an unknown date, the outcome of the injection site swelling, injection site erythema and injection site warmth were unknown.   It was unknown if the reporter considered the injection site swelling, injection site erythema and injection site warmth to be related to Shingrix.  Additional details were provided as follows: The age at vaccination was not applicable. HCP did not provide how many patients were involved. No date of birth or any demographics for the other patients involved were reported. The patients experienced swelling, redness, and heat at injection site following a dose of Shingrix.  The events lasted for 4 to 5 days following administration. No additional information provided. The case has been linked with the case US2020161263 and US2020161260, reported as same reporter. The reporter consented to follow up.; Sender's Comments:  US-GLAXOSMITHKLINE-US2020161260:same reporter US-GLAXOSMITHKLINE-US2020161263:reporter's case
Sex: F
Vaccine: VARZOS
Symptoms: Herpes zoster, Vaccination failure
Clinical narrative: wound up with the shingles/suspected vaccination failure; wound up with the shingles; This case was reported by a consumer via interactive digital media and described the occurrence of suspected vaccination failure in a female 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 vaccination failure (serious criteria GSK medically significant) and shingles. On an unknown date, the outcome of the vaccination failure and shingles were unknown.   It was unknown if the reporter considered the vaccination failure and shingles to be related to Shingrix.  Additional details were provided as follows: The age at vaccination was not reported. It was reported that the patient got the shingles vaccine and patient still wound up with the shingles. The vaccine did not 100% prevent.  This case was considered as suspected vaccination failure since the details regarding dose number, time to onset and laboratory confirmation were not given. This case has been linked with the case US2020AMR164915 reported by same reporter.; Sender's Comments:  US-GLAXOSMITHKLINE-US2020AMR164915:same reporter US-GLAXOSMITHKLINE-US2020AMR164914:same reporter
Sex: U
Vaccine: TDAP
Symptoms: Pertussis, Vaccination failure
Clinical narrative: Suspected vaccination failure; Whooping cough; This case was reported by a consumer via interactive digital media and described the occurrence of suspected vaccination failure in a patient who received DTPa (Reduced antigen) (Tdap Vaccine) for prophylaxis.   On an unknown date, the patient received Tdap Vaccine. On an unknown date, unknown after receiving Tdap Vaccine, the patient experienced vaccination failure (serious criteria GSK medically significant) and whooping cough (serious criteria GSK medically significant). On an unknown date, the outcome of the vaccination failure and whooping cough were unknown.   It was unknown if the reporter considered the vaccination failure and whooping cough to be related to Tdap Vaccine.  Additional details were provided as follows: The age at vaccination was not reported. The patient reported that last time the patient had Tdap vaccination and expereinced whooping cough. The patient stated he or she would nover receive vaccine again. This case was considered as suspected vaccination failure since the details regarding primary vaccination schedule, time to onset and lab test confirming whooping cough are not reported.
Sex: U
Vaccine: VARZOS
Symptoms: Pyrexia
Clinical narrative: Fever / Low grade fever; This case was reported by a consumer via interactive digital media and described the occurrence of fever in a patient who received Herpes zoster (Shingrix) for prophylaxis.   On 17th August 2020, the patient received Shingrix. On 17th August 2020, less than a day after receiving Shingrix, the patient experienced fever. On an unknown date, the outcome of the fever was unknown.   It was unknown if the reporter considered the fever 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 adult as per vaccine indication. The patient received Shingrix on the day of reporting in morning The patient asked Should patient take Tylenol with the fever at the time of reporting had a low grade fever if 99.3, but if patient get a fever of 101 or higher, was it okay to take Tylenol.
Sex: U
Vaccine: VARZOS
Symptoms: Fatigue
Clinical narrative: Is it normal to have fatigue after getting your Shingrix?; This case was reported by a consumer via interactive digital media and described the occurrence of fatigue in a adult 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 fatigue. On an unknown date, the outcome of the fatigue was unknown.   It was unknown if the reporter considered the fatigue to be related to Shingrix.  Additional details were provided as follows: The age at vaccination was not reported. The age group was not reported but it was selected as adult as per the vaccine indication. The patient received Shingrix and had fatigue. The reporter asked was it normal to have fatigue after getting your Shingrix.
Sex: U
Vaccine: VARZOS
Symptoms: Herpes zoster, Pruritus, Rash, Skin swelling
Clinical narrative: Shingles episode; puffy rash; puffy rash across the bridge of my nose and arching up to my right eyebrow and it is itchy; puffy rash across; This case was reported by a consumer via interactive digital media and described the occurrence of shingles in a adult patient who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included Shingrix.   In August 2020, the patient received the 2nd dose of Shingrix. In August 2020, less than a week after receiving Shingrix, the patient experienced shingles, rash, pruritus and puffy skin. On an unknown date, the outcome of the shingles, rash, pruritus and puffy skin were unknown.   It was unknown if the reporter considered the shingles, rash, pruritus and puffy skin to be related to Shingrix.  Additional details were provided as follows: The age at vaccination was not reported. The patient received the Shingrix shot series, the last one about 5 days ago. The patient getting a puffy rash across the bridge of my nose and arching up to my right eyebrow and it is itchy.  The patient asked it possible for the vaccine to trigger a Shingles episode.
Age: 60.0
Sex: F
Vaccine: VARZOS
Symptoms: Injected limb mobility decreased, Muscle swelling, Musculoskeletal pain, Myalgia, Pain in extremity
Clinical narrative: excruciating pain occurs when extending arm/trying to reach forward and backward using left arm is excruciating./freezes up shoulder/muscle in arm where injected began to swell; pain in muscle where vaccine was injected; excruciating pain occurs when extending arm/trying to reach forward and backward using left arm is excruciating.; severe pain that extends and freezes up shoulder; excruciating; Swelling reportedly lasted six days; This case was reported by a consumer via call center representative and described the occurrence of injected limb mobility decreased in a 60-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   On 7th July 2020, the patient received the 1st dose of Shingrix (intramuscular) 50 ug. On 7th July 2020, less than a day after receiving Shingrix, the patient experienced injected limb mobility decreased, muscle pain, pain in arm, shoulder pain, muscle swelling and pain. On an unknown date, the outcome of the injected limb mobility decreased, muscle pain, pain in arm and shoulder pain were not recovered/not resolved and the outcome of the muscle swelling and pain were recovered/resolved.   It was unknown if the reporter considered the injected limb mobility decreased, muscle pain, pain in arm, shoulder pain, muscle swelling and pain to be related to Shingrix.  Additional details were provided as follows: On 7th July 2020, within a matter of hours developed pain in muscle where vaccine was injected. Next, muscle in arm where injected began to swell. Swelling reportedly lasted six days.  Currently, affected arm does not had a constant pain, but excruciating pain occurs when extending arm, and consumer described severe pain that extends and freezes up shoulder. Consumer describes trying to reach forward and backward using left arm is excruciating.  The reporter consent to follow up.
Sex: F
Vaccine: VARZOS
Symptoms: Immediate post-injection reaction, Lymphadenitis, Lymphadenopathy, Product administered at inappropriate site
Clinical narrative: Lymphadenitis; Lymphadenopathy in her axila; Injection was not properly administered, it was given to low in the arm / administered in a lower part of the deltoid; This case was reported by a nurse via sales rep and described the occurrence of lymphadenitis in a adult female patient who received Herpes zoster (Shingrix) for prophylaxis.   In August 2020, the patient received the 1st dose of Shingrix. In August 2020, immediately after receiving Shingrix, the patient experienced lymphadenitis, lymphadenopathy axillary and vaccine administered at inappropriate site. On an unknown date, the outcome of the lymphadenitis, lymphadenopathy axillary and vaccine administered at inappropriate site were unknown.   It was unknown if the reporter considered the lymphadenitis and lymphadenopathy axillary to be related to Shingrix.  Additional details were provided as follows: The age at vaccination was not reported but the patient was in her fifties at the time of reporting. It was reported that a patient received the 1st dose of Shingrix a week and half ago and right away developed a lymphadenopathy in her axila and lymphadenitis. The symptom was localized and it was resolved at the time of reporting.  It was mentioned that the injection was not properly administered and the patient considered that the injection was administered in a lower part of the deltoid, which led to vaccine administered at inappropriate site. The reporter consented to follow up.; Sender's Comments:  US-GLAXOSMITHKLINE-US2020161273:FU1 deleted
Sex: M
Vaccine: VARZOS
Symptoms: Injection site pain, Insomnia
Clinical narrative: trouble sleeping for the past few weeks due to soreness; soreness in left arm around injection site; This case was reported by a consumer via call center representative and described the occurrence of difficulty sleeping in a elderly male patient who received Herpes zoster (Shingrix) for prophylaxis.   The patient's past medical history included artificial cardiac pacemaker user (pacemaker placed on 21st February 2020 ). Previously administered products included Shingrix (received 1st dose in January 2020 or February 2020 in left arm, see case US2020AMR165198).   In June 2020, the patient received the 2nd dose of Shingrix (intramuscular). On an unknown date, less than 2 months after receiving Shingrix, the patient experienced difficulty sleeping and injection site pain. On an unknown date, the outcome of the difficulty sleeping and injection site pain were not recovered/not resolved.   It was unknown if the reporter considered the difficulty sleeping and injection site pain to be related to Shingrix.  Additional details were provided as follows: The age at vaccination was not reported. The patient received second dose about 2 months ago.  The patient reported both doses of Shingrix were given in the left arm. The patient reported soreness in left arm around injection site that started a few weeks ago and was still ongoing. The patient reported trouble sleeping for the past few weeks due to soreness in the left arm and this was still ongoing at the time of reporting. The patient did not have lot or expiration date information for either dose of Shingrix. The reporter did not consent to follow-up.; Sender's Comments:  US-GLAXOSMITHKLINE-US2020AMR165198:1st dose
Age: 54.0
Sex: F
Vaccine: VARZOS
Symptoms: Chills, Extensive swelling of vaccinated limb, Muscle spasms
Clinical narrative: chills; and involuntary muscle spasms; swelling on her right arm; This case was reported by a consumer via call center representative and described the occurrence of extensive swelling of vaccinated limb in a 54-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   The patient's past medical history included shingles (got misdiagnosed as poison ivy when she was 45 years old).   On 28th February 2020, the patient received the 1st dose of Shingrix (intramuscular). In February 2020, less than a day after receiving Shingrix, the patient experienced chills and muscle spasm. On 1st March 2020, the patient experienced extensive swelling of vaccinated limb. The patient was treated with benadryl (nos) (Benadryl). On an unknown date, the outcome of the extensive swelling of vaccinated limb, chills and muscle spasm were recovered/resolved.   It was unknown if the reporter considered the extensive swelling of vaccinated limb, chills and muscle spasm to be related to Shingrix.  Additional details were provided as follows: The age at vaccination was not reported. The patient received Shingrix on right arm. The patient received Shingrix in the early afternoon on 28th February 2020. After receiving Shingrix, from 1 AM to 4 PM, the patient experienced chills and involuntary muscle spasms which she described as similar to Parkinson's disease in her arms and legs.  The patient took Benadryl and the spasms resolved.   On Sunday 1st March 2020, in the afternoon, the patient experienced swelling on her right arm at the injection site for two days and she described the swelling as the size of a giant baseball under her skin. The patient took more Benadryl and by the evening the swelling resolved after lasting for 6 hours.
Age: 71.0
Sex: F
Vaccine: VARZOS
Symptoms: Headache, Scleritis
Clinical narrative: Sclerotic right eye; Severe headache; This case was reported by a nurse via call center representative and described the occurrence of scleritis in a 71-year-old female patient who received Herpes zoster (Shingrix) (batch number C7EX2, expiry date unknown) for prophylaxis.   On 20th July 2020, the patient received the 1st dose of Shingrix. On 23rd July 2020, 3 days after receiving Shingrix, the patient experienced scleritis (serious criteria GSK medically significant) and headache. The patient was treated with indometacin (Indomethacin). On an unknown date, the outcome of the scleritis and headache were unknown.   It was unknown if the reporter considered the scleritis and headache to be related to Shingrix.  Additional details were reported as follows: The patient developed an sclerotic eye (right eye) and severe headache 3 days after vaccination. On 27th July 2020, she attended a walk in urgent care facility due to the adverse event. The patient then attended an emergency room on 30th July 2020 and again on 31st July 2020. The patient was derived to an ophthalmologist on 31st July 2020 and was prescribed with indomethacin.  The reporter consented to follow up. The batch number was reported as C7EY2 however it was updated to C7EX2 as per sales data sheet.
Age: 62.0
Sex: M
Vaccine: VARZOS
Symptoms: Chills, Fatigue, Influenza like illness, Pain, Pyrexia
Clinical narrative: Rash/ red rash/patch on below the injection site that is red; is tender to touch; Pain; flu-like symptoms; Fevers and Chills; chills; felt fatigued; This case was reported by a consumer via call center representative and described the occurrence of influenza-like symptoms in a 62-year-old male patient who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included Shingrix with an associated reaction of feeling abnormal (for tolerance of 1st dose refer case US2020AMR165271).   On 14th August 2020, the patient received the 2nd dose of Shingrix (intramuscular). On 14th August 2020, less than a day after receiving Shingrix, the patient experienced influenza-like symptoms, fever, chills and fatigue. On 15th August 2020, the patient experienced red rash, tenderness and pain. On 15th August 2020, the outcome of the influenza-like symptoms, fever and chills were recovered/resolved and the outcome of the fatigue was recovered/resolved. On an unknown date, the outcome of the red rash, tenderness and pain were not recovered/not resolved.   It was unknown if the reporter considered the influenza-like symptoms, red rash, fever, chills, fatigue, tenderness and pain to be related to Shingrix.  Additional details were reported as follows: The patient received 2nd dose of vaccine in right deltoid. The patient received his second dose and noticed that day he felt fatigued, had fever and chills ,flu-like symptoms that resolved. The reporter did noticed a patch on below the injection site that was red but not itchy. He stated each day since the rash has formed that it had gotten larger and noticed that it was tender to touch but unsure if its due to the rash or the injection.  The lot number and expiry date not provided. The reporter did not consent to follow up.; Sender's Comments:  US-GLAXOSMITHKLINE-US2020AMR165271:same reporter
Age: 62.0
Sex: M
Vaccine: VARZOS
Symptoms: Rash erythematous, Tenderness
Clinical narrative: Rash/ red rash/patch on below the injection site that is red; is tender to touch; Pain; flu-like symptoms; Fevers and Chills; chills; felt fatigued; This case was reported by a consumer via call center representative and described the occurrence of influenza-like symptoms in a 62-year-old male patient who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included Shingrix with an associated reaction of feeling abnormal (for tolerance of 1st dose refer case US2020AMR165271).   On 14th August 2020, the patient received the 2nd dose of Shingrix (intramuscular). On 14th August 2020, less than a day after receiving Shingrix, the patient experienced influenza-like symptoms, fever, chills and fatigue. On 15th August 2020, the patient experienced red rash, tenderness and pain. On 15th August 2020, the outcome of the influenza-like symptoms, fever and chills were recovered/resolved and the outcome of the fatigue was recovered/resolved. On an unknown date, the outcome of the red rash, tenderness and pain were not recovered/not resolved.   It was unknown if the reporter considered the influenza-like symptoms, red rash, fever, chills, fatigue, tenderness and pain to be related to Shingrix.  Additional details were reported as follows: The patient received 2nd dose of vaccine in right deltoid. The patient received his second dose and noticed that day he felt fatigued, had fever and chills ,flu-like symptoms that resolved. The reporter did noticed a patch on below the injection site that was red but not itchy. He stated each day since the rash has formed that it had gotten larger and noticed that it was tender to touch but unsure if its due to the rash or the injection.  The lot number and expiry date not provided. The reporter did not consent to follow up.; Sender's Comments:  US-GLAXOSMITHKLINE-US2020AMR165271:same reporter
Age: 73.0
Sex: M
Vaccine: VARZOS
Symptoms: Abdominal pain upper, Chills, Diarrhoea, Fatigue, Feeling hot
Clinical narrative: Stomach hurt; continuous diarrhea; muscle pain; chills; tired; severe sweating; Feel warm; Body pain; This case was reported by a consumer via call center representative and described the occurrence of stomach pain in a 73-year-old male patient who received Herpes zoster (Shingrix) for prophylaxis.   In July 2020, the patient received the 1st dose of Shingrix. In July 2020, couple of hours after receiving Shingrix, the patient experienced chills, tiredness, sweating, feeling of warmth and general body pain. On an unknown date, the patient experienced stomach pain, diarrhea and muscle pain. Shingrix was discontinued. On an unknown date, the outcome of the stomach pain, diarrhea, muscle pain, chills, tiredness, sweating, feeling of warmth and general body pain were recovered/resolved.   The reporter considered the stomach pain, diarrhea, muscle pain, chills, tiredness, sweating, feeling of warmth and general body pain to be related to Shingrix.  Additional details were reported as follows: The reporter stated that he received 1st dose of the Shingrix about 3 weeks ago and within few hours of receiving the vaccine in his right arm, he started to feel warm and had severe sweating, felt tired, then started to have chills with body pain. The patient's stomach hurt with continuous diarrhea for about 4 days.  After about 4 to 5 days, all the adverse events resolved The healthcare professional ordered a covid 19 test and it was negative. The healthcare professional has advised patient to not get the second dose of the Shingrix vaccine due to these adverse events. The patient wanted to get a refund because he was only entitled to one shot and his doctor told him to definitely not get the second shot so patient did not get the full benefit of the shot. But they informed patient that no refunds were going to be given to him. The reporter consented to follow up.
Age: 73.0
Sex: M
Vaccine: VARZOS
Symptoms: Hyperhidrosis, Myalgia, Pain, SARS-CoV-2 test negative
Clinical narrative: Stomach hurt; continuous diarrhea; muscle pain; chills; tired; severe sweating; Feel warm; Body pain; This case was reported by a consumer via call center representative and described the occurrence of stomach pain in a 73-year-old male patient who received Herpes zoster (Shingrix) for prophylaxis.   In July 2020, the patient received the 1st dose of Shingrix. In July 2020, couple of hours after receiving Shingrix, the patient experienced chills, tiredness, sweating, feeling of warmth and general body pain. On an unknown date, the patient experienced stomach pain, diarrhea and muscle pain. Shingrix was discontinued. On an unknown date, the outcome of the stomach pain, diarrhea, muscle pain, chills, tiredness, sweating, feeling of warmth and general body pain were recovered/resolved.   The reporter considered the stomach pain, diarrhea, muscle pain, chills, tiredness, sweating, feeling of warmth and general body pain to be related to Shingrix.  Additional details were reported as follows: The reporter stated that he received 1st dose of the Shingrix about 3 weeks ago and within few hours of receiving the vaccine in his right arm, he started to feel warm and had severe sweating, felt tired, then started to have chills with body pain. The patient's stomach hurt with continuous diarrhea for about 4 days.  After about 4 to 5 days, all the adverse events resolved The healthcare professional ordered a covid 19 test and it was negative. The healthcare professional has advised patient to not get the second dose of the Shingrix vaccine due to these adverse events. The patient wanted to get a refund because he was only entitled to one shot and his doctor told him to definitely not get the second shot so patient did not get the full benefit of the shot. But they informed patient that no refunds were going to be given to him. The reporter consented to follow up.
Age: 87.0
Sex: F
Vaccine: VARZOS
Symptoms: Deafness, Eyelid ptosis, Facial paralysis
Clinical narrative: Experienced an episode of Bell's Palsy / facial and eye droop / Initially thought she was having a stroke; Had hearing loss; Eye droop on her lower eye lid; This case was reported by a consumer via call center representative and described the occurrence of bell's palsy in a elderly female patient who received Herpes zoster (Shingrix) for prophylaxis.   On 28th February 2019, the patient received the 1st dose of Shingrix. On an unknown date, less than 2 weeks after receiving Shingrix, the patient experienced bell's palsy (serious criteria GSK medically significant), hearing loss (serious criteria GSK medically significant) and ptosis. On an unknown date, the outcome of the bell's palsy and hearing loss were not recovered/not resolved and the outcome of the ptosis was unknown.   It was unknown if the reporter considered the bell's palsy, hearing loss and ptosis to be related to Shingrix.  Additional information was received as follows: This case was reported from the daughter of the patient. The patient received the first dose of Shingrix and within a week or a week and a half she experienced an episode of Bell's Palsy.  She had hearing loss which was worse with facial and eye droop on her lower eye lid.  Her physician did an eye lift.  The lower eye lid occurred slowly and they initially thought she was having a stroke. The reporter consented to follow up.
Age: 53.0
Sex: F
Vaccine: VARZOS
Symptoms: Erythema, Extensive swelling of vaccinated limb, Feeling hot, Headache, Injection site rash
Clinical narrative: There was a large red, swollen, hot patch and rash at the injection site that traveled way down the left arm to the left side of the waist.; rash; There was a large red on arm; hot patch; itchy on arm; severe headache; The arm is still untouchable due to the pain/muscle pain; This case was reported by a consumer via call center representative and described the occurrence of extensive swelling of vaccinated limb in a 53-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   The patient's past medical history included hemiplegic migraine.   On 14th August 2020, the patient received the 1st dose of Shingrix. On 14th August 2020, 5 hrs after receiving Shingrix, the patient experienced extensive swelling of vaccinated limb, rash over arms, redness, hot feeling in hand, itchy, headache and muscle pain. The patient was treated with benadryl (nos) (Benadryl) and ibuprofen. On an unknown date, the outcome of the extensive swelling of vaccinated limb, rash over arms, redness, hot feeling in hand, itchy, headache and muscle pain were not recovered/not resolved.   It was unknown if the reporter considered the extensive swelling of vaccinated limb, rash over arms, redness, hot feeling in hand, itchy, headache and muscle pain to be related to Shingrix.  Additional information was received as follows: The patient started to experience the symptoms 5 hours after the vaccination. There was a large red, swollen, hot patch and rash at the injection site that traveled way down the left arm to the left side of the waist. The arm was still untouchable due to the pain. She had been icing the areas. The patient was treated with benadryl and ibuprofen. The reporter consented to follow up.