chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Sex: U
Vaccine: HPV9, UNK
Symptoms: Circumstance or information capable of leading to medication error, Inappropriate schedule of product administration, No adverse event
Clinical narrative: No adverse affects reported; has not yet received the second dose in the vaccination series; has not yet received the second dose in the vaccination series/ Altered dosing schedule; This spontaneous report was received from a pharmacist 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 29-FEB-2020 the patient was vaccinated with first dose of hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast) (GARDASIL 9) (lot # R028387, expiration date 27-JUL-2021; dose, frequency and route were not reported) for prophylaxis.         The patient had not yet received the second dose in the vaccination series at the time of report (circumstance or information capable of leading to medication error, inappropriate schedule of product administration). No adverse effects were reported. 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.; manufactureraddress: ; manufacturercity: ; manufacturerstate: ; manufacturercountry: ; devicelotnumber: R028387; expirationdate: 27-JUL-2021; 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
Sex: U
Vaccine: RV5
Symptoms: No adverse event, Product storage error
Clinical narrative: no adverse event; patient receivedimprperly stored dose of rotateq; This spontaneous report was received from medical assistant refers to a patient of unknown age and gender. The patient's pertinent medical history, drug reactions/allergies and concomitant medications were not reported. On 30-APR-2020, the patient was vaccinated with improperly stored rotavirus vaccine, live, oral, pentavalent (therapy type: Digital Data Logger) (ROTATEQ) one dose for prophylaxis (strength, dose, route, lot/ batch number and expiry date were not reported (product storage error). The administered dose of the vaccine experienced a temperature excursion of 35 Fahrenheit for a time frame of 8 hours as recorded by a data logger. The vaccines had no previous temperature excursion. The patient experienced no adverse event. No product quality complaint was reported. The outcome of product storage error and no adverse event was unknown.  This is one of the several reports from the same reporter.; Sender's Comments:  US-009507513-2005USA000643:
Age: 0.5
Sex: U
Vaccine: RV5
Symptoms: Expired product administered, No adverse event
Clinical narrative: No additional adverse effects reported; Administered an expired dose of properly storedd rotateq; product used for unapproved age; This spontaneous report was received from a nurse, referring to a 6-month-old infant of unknown gender. Information regarding the patient's pertinent medical history, concurrent condition, drug reactions/allergies and concomitant medication were not provided.  On 23-APR-2020, the patient was administered an expired dose of properly stored rotavirus vaccine, live, oral, pentavalent (ROTATEQ) (strength and dose were not reported, lot# R016790; expiry date reported and validated as 20-APR-2020) for prophylaxis (product administered to patient of inappropriate age and expired product administered). This was the patient's second dose of rotavirus vaccine, live, oral, pentavalent (ROTATEQ). No additional adverse effects were reported. There was no associated product quality complaint.
Sex: U
Vaccine: RV5
Symptoms: No adverse event, Product storage error
Clinical narrative: No additional adverse events reported; the patient received an improperly stored dose of ROTATEQ; This spontaneous report was received from a medical assistant referring to a patient of unknown age and gender. The patient's concurrent conditions, pertinent medical history, concomitant medications, drug reactions/allergies were not reported.    On 27-APR-2020, the patient received improperly stored rotavirus vaccine, live, oral, pentavalent (ROTATEQ) 1 dose (strength, route of administration, lot # and expiration date were not provided) as prophylaxis (product storage error). The vaccines were exposed to temperature of 35 degrees Fahrenheit for 8 hours. No previous excursions was reported. The data logger was involved. No additional adverse effects were reported.; Sender's Comments:  US-009507513-2005USA000681: US-009507513-2005USA000643: US-009507513-2005USA000528:
Sex: U
Vaccine: RV5
Symptoms: No adverse event, Product storage error
Clinical narrative: No additional adverse events reported.; Patient received an improperly stored dose of ROTATEQ.; This spontaneous report was received from a medical assistant referring to a patient of unknown age and gender. The patient's concurrent conditions, medical history, drug allergy/ reaction and concomitant medications were not reported. On 22-APR-2020, the patient was vaccinated with improperly stored rotavirus vaccine, live, oral, pentavalent (ROTATEQ) (product storage error) (dose: 1 dose, frequency, route, lot#, expiry date was not reported) for prophylaxis. The vaccine was stored at a temperature of 35-degree Fahrenheit for 8 hours. There was no previous temperature excursion. The call was because of data logger. No adverse effect was reported. The outcome of product storage error and no adverse event was unknown.
Sex: U
Vaccine: PPV
Symptoms: Product storage error
Clinical narrative: the patient was administered an improperly stored dose of PNEUMOVAX 23; This spontaneous report as received from a nurse refers to a patient of an unknown age and gender. The report concerns 1 patient and 1 combination product. Information about concurrent condition, concomitant medication and medical history was not provided.  On 13-SEP-2019, the patient was vaccinated with an improperly stored dose of pneumococcal vaccine, polyvalent (23-valent) (PNEUMOVAX23), lot # S004548, expiration date 12-AUG-2020 (exact dose and route of administration were not reported) for prophylaxis. The administered dose of vaccine experienced temperature excursion of 47.3 degrees Fahrenheit for 20 minutes. There was no previous temperature excursion. The digital date logger was involved.  combinationproductreport: Yes; brandname: PNEUMOVAX23 SYRINGE (DEVICE); commondevicename: Pneumococcal Vaccine, Polyvalent (23-valent); productcode: FMF; devicetype: SYRINGE, PISTON (FMF); manufacturername: Merck Sharp & Dohme Corp. devicelotnumber: S004548; expirationdate: 12-AUG-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
Sex: U
Vaccine: HEP
Symptoms: No adverse event, Product storage error
Clinical narrative: No additional adverse effects reported; was administered an improperly stored dose of RECOMBIVAX; 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 01-MAY-2020, the patient was administered an improperly stored dose of hepatitis b vaccine (recombinant) (RECOMBIVAX HB) (lot # reported as S000961 and expiration date 19-OCT-2020; strength, dose and route were not reported) for prophylaxis (product storage error). Temperature excursion was 47.6 Fahrenheit degrees for 2 hours 42 minutes. There was no previous temperature excursion. No additional adverse effects were reported.
Sex: F
Vaccine: VARZOS
Symptoms: Facial paralysis
Clinical narrative: Bell's Palsy; Information has been received from a lawyer regarding a case in litigation and refers to a female patient (pt) of an unknown age. No information was provided regarding medical history, concurrent conditions, or concomitant medications. In 2012, the pt was inoculated with zoster vaccine live (ZOSTAVAX) as prescribed and/or administered by a pharmacist at a pharmacy (strength, dose, dose number, route, anatomical site of vaccination, lot number and expiration date were not provided) for the long-term prevention of shingles and/or zoster-related conditions. On an unknown date (reported as subsequent after receiving zoster vaccine live (ZOSTAVAX)), the pt was treated by a healthcare provider for Bell's Palsy (facial paralysis). Then, on an unknown date, she was hospitalized due to the event. As a direct and proximate result of pt's use of the zoster vaccine live (ZOSTAVAX) vaccine, pt had and would continue suffer ongoing injuries, including but not limited to: mental and physical pain and suffering; medical care and treatment for these injuries; significant medical and related expenses as a result of these injuries, including but not limited to medical losses and costs include care for hospitalization, physician care, monitoring, treatment, medications, and supplies; diminished capacity for the enjoyment of life; diminished quality of life; increased risk of premature death, aggravation of preexisting conditions and activation of latent conditions; and other losses and damages; and would continue to suffer such losses, and damages in the future. The outcome of facial paralysis was unknown. The reporter assessed that the event was related to zoster vaccine live (ZOSTAVAX).  Upon internal review, facial paralysis was determined to be a medically significant event.
Sex: F
Vaccine: VARZOS
Symptoms: Back pain, Blister, Breast pain, Erythema, Eye pain
Clinical narrative: Pt suffered blisters and redness on the right side of her back wrapping around and under the right breast accompanied with sharp pain. Pt was diagnosed with shingles and nerve pain.; blurry vision; throbbing pain in her eyes; Pt suffered blisters and redness on the right side of her back wrapping around and under the right breast accompanied with sharp pain. Pt was diagnosed with shingles and nerve pain.; Information has been received from a lawyer regarding a case in litigation and refers to a female patient (pt) of an unknown age. No information was provided regarding medical history, concurrent conditions, or concomitant medications. On or about 08-FEB-2017, the pt was inoculated with zoster vaccine live (ZOSTAVAX) (strength, dose, dose number, route, anatomical site of vaccination, lot number and expiration date were not provided) for routine health maintenance and for its intended purpose: the prevention of shingles (herpes zoster). On an unknown date (reported as shortly after receiving zoster vaccine live (ZOSTAVAX)), the pt suffered blisters and redness on the right side of her back wrapping around and under the right breast accompanied with sharp pain. Pt was diagnosed with shingles (herpes zoster) and nerve pain (neuralgia). Pt also experienced blurry vision (vision blurred) and throbbing pain in her eyes (eye pain) shortly after receiving the vaccine. As a direct and proximate result of zoster vaccine live (ZOSTAVAX) vaccine, pt's symptoms had resulted in physical limitations not present prior to using zoster vaccine live (ZOSTAVAX). She also experienced mental and emotional distress due to resulting physical limitations and seriousness of her condition. Pt sustained severe and permanent personal injuries. Pt suffered serious, progressive, permanent, and incurable injuries, as well as significant conscious pain and suffering, mental anguish, emotional distress, loss of enjoyment of life, physical impairment and injury. As a direct and proximate result of zoster vaccine live (ZOSTAVAX) vaccine, pt had suffered and incurred damages, including medical expenses; the loss of accumulations; and other economic and non-economic damages. The outcome of neuralgia, herpes zoster, eye pain and vision blurred was not recovered. The reporter assessed that the events were related to zoster vaccine live (ZOSTAVAX).  Neuralgia, herpes zoster, eye pain and vision blurred have been considered disabling events by the reporter.
Sex: F
Vaccine: VARZOS
Symptoms: Herpes zoster, Neuralgia, Pain, Vision blurred
Clinical narrative: Pt suffered blisters and redness on the right side of her back wrapping around and under the right breast accompanied with sharp pain. Pt was diagnosed with shingles and nerve pain.; blurry vision; throbbing pain in her eyes; Pt suffered blisters and redness on the right side of her back wrapping around and under the right breast accompanied with sharp pain. Pt was diagnosed with shingles and nerve pain.; Information has been received from a lawyer regarding a case in litigation and refers to a female patient (pt) of an unknown age. No information was provided regarding medical history, concurrent conditions, or concomitant medications. On or about 08-FEB-2017, the pt was inoculated with zoster vaccine live (ZOSTAVAX) (strength, dose, dose number, route, anatomical site of vaccination, lot number and expiration date were not provided) for routine health maintenance and for its intended purpose: the prevention of shingles (herpes zoster). On an unknown date (reported as shortly after receiving zoster vaccine live (ZOSTAVAX)), the pt suffered blisters and redness on the right side of her back wrapping around and under the right breast accompanied with sharp pain. Pt was diagnosed with shingles (herpes zoster) and nerve pain (neuralgia). Pt also experienced blurry vision (vision blurred) and throbbing pain in her eyes (eye pain) shortly after receiving the vaccine. As a direct and proximate result of zoster vaccine live (ZOSTAVAX) vaccine, pt's symptoms had resulted in physical limitations not present prior to using zoster vaccine live (ZOSTAVAX). She also experienced mental and emotional distress due to resulting physical limitations and seriousness of her condition. Pt sustained severe and permanent personal injuries. Pt suffered serious, progressive, permanent, and incurable injuries, as well as significant conscious pain and suffering, mental anguish, emotional distress, loss of enjoyment of life, physical impairment and injury. As a direct and proximate result of zoster vaccine live (ZOSTAVAX) vaccine, pt had suffered and incurred damages, including medical expenses; the loss of accumulations; and other economic and non-economic damages. The outcome of neuralgia, herpes zoster, eye pain and vision blurred was not recovered. The reporter assessed that the events were related to zoster vaccine live (ZOSTAVAX).  Neuralgia, herpes zoster, eye pain and vision blurred have been considered disabling events by the reporter.
Sex: M
Vaccine: VARZOS
Symptoms: Ophthalmic herpes zoster
Clinical narrative: shingles on the right eye; Information has been received from a lawyer regarding a case in litigation concerning a male patient(pt) of unknown age. The pt's medical history, concurrent conditions and concomitant medications were not provided. On or about 10-MAY-2018, the pt was inoculated with zoster vaccine live(ZOSTAVAX), as prescribed and/or administered by a healthcare provider at a physicians office for the long-term prevention of shingles and/or zoster-related conditions. Subsequent to zoster vaccine live(ZOSTAVAX) inoculation, pt was treated by a physician for shingles on the right eye. As a direct and proximate result of zoster vaccine live(ZOSTAVAX), pt has and will continue suffer ongoing injuries, including but not limited to: mental and physical pain and suffering; medical care and treatment for these injuries; significant medical and related expenses as a result of these injuries, including but not limited to medical losses and costs include care for hospitalization, physician care, monitoring, treatment, medications, and supplies; diminished capacity for the enjoyment of life; diminished quality of life; increased risk of premature death, aggravation of preexisting conditions and activation of latent conditions; and other losses and damages; and will continue to suffer such losses, and damages in the future.   Upon internal review, shingles on the right eye was determined to be medically significant.
Sex: U
Vaccine: HEP
Symptoms: Extra dose administered, No adverse event
Clinical narrative: Received 2nd Dose 2 Weeks Later; Initial Report Received on 18-Feb-2020  A nurse reported that a female  received a dose of HEPLISAV-B (hepatitis B vaccine) for hepatitis B immunization on 31-Jan-2020 in the left deltoid.  Relevant medical history and concomitant medications were not reported.    On 14-Feb-2010, 15 days after having received the first injection, the patient received the second injection (Batch Number 933840, Expiration 19-Apr-2021) in the left deltoid.  The nurse reported that there have been no reported adverse reactions to the injections.   No further information was provided.    The reporter did not provide a serious assessment for the event.  Company comment: The company assessed the event as non-serious.; Sender's Comments: The company assessed the event as non-serious.
Sex: U
Vaccine: HEP
Symptoms: Inappropriate schedule of product administration, No adverse event
Clinical narrative: Received Second Dose in Less Than 4 Weeks; Initial Report Received on 19-Feb-2020  A nurse reported that a patient (unknown age, race and gender) received a dose of HEPLISAV-B (hepatitis B vaccine) for hepatitis B immunization on 31-Jan-2020.  Relevant medical history and concomitant medications were not reported.    On 14-Feb-2010, 15 days after having received the first injection, the patient received the second injection (Batch Number 933840, Expiration 19-Apr-2021).  The nurse reported that the patient did not experience any side effects per their follow-up.  No further information was provided.    The reporter did not provide either a serious or severity Grade assessment for the event.  Company comment: The company assessed the event as non-serious.; Sender's Comments: The company assessed the event as non-serious.
Sex: F
Vaccine: HEP
Symptoms: Exposure during pregnancy
Clinical narrative: Pregnancy; Delivered Healthy Infant; Initial Report Received on 23-Apr-2020 and 27-Apr-2020  A Pharmacist reported a retrospective pregnancy outcome to the pregnancy registry.  The Pharmacist reported that a pregnant female was vaccinated with HEPLISAV-B on 06-Feb-2019 (Lot # 933093).  40.5 weeks of gestation, the female delivered a healthy infant.   On 07-Aug-2019, the female received another vaccination with HEPLISAV-B (Lot # 933840).    The reporter noted that this pregnancy report had previously been reported to VAERs about a week after exposure last year.    No additional information was provided.  Company comment: The company assessed the event as non-serious.; Sender's Comments: The company assessed the event as non-serious.
Age: 74.0
Sex: F
Vaccine: VARZOS
Symptoms: Asthenia, Headache, Musculoskeletal pain, Pain, Pain in extremity
Clinical narrative: pain down my fingertips/experiencing pain at injection site; pain extending up to her shoulder; severe pain / ached all over my body; developed fever; headache; did not have any energy; This case was reported by a consumer via other manufacturer and described the occurrence of pain in fingers in a 74-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   On 20th February 2020, the patient received the 1st dose of Shingrix. In February 2020, 4 hrs after receiving Shingrix, the patient experienced pain in fingers, shoulder pain, general body pain, fever, headache and loss of energy. The patient was treated with ibuprofen (Advil). On an unknown date, the outcome of the pain in fingers, shoulder pain, general body pain, fever, headache and loss of energy were recovered/resolved.   It was unknown if the reporter considered the pain in fingers, shoulder pain, general body pain, fever, headache and loss of energy to be related to Shingrix.  Additional details were provided as follows: At 1:00 pm, the patient received Shingrix vaccine and by 5:00 pm the patient was experiencing pain at the injection site and extending up to her shoulder and down to the fingertips. By late evening had developed fever, headache and severe pain.  The patient also mentioned that she did not have any energy and ached all over her body. The patient stated that the next day she took advil which eased the pain and that it took a full week to start feeling better. No further AE information was provided.
Age: 74.0
Sex: F
Vaccine: VARZOS
Symptoms: Pyrexia
Clinical narrative: pain down my fingertips/experiencing pain at injection site; pain extending up to her shoulder; severe pain / ached all over my body; developed fever; headache; did not have any energy; This case was reported by a consumer via other manufacturer and described the occurrence of pain in fingers in a 74-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   On 20th February 2020, the patient received the 1st dose of Shingrix. In February 2020, 4 hrs after receiving Shingrix, the patient experienced pain in fingers, shoulder pain, general body pain, fever, headache and loss of energy. The patient was treated with ibuprofen (Advil). On an unknown date, the outcome of the pain in fingers, shoulder pain, general body pain, fever, headache and loss of energy were recovered/resolved.   It was unknown if the reporter considered the pain in fingers, shoulder pain, general body pain, fever, headache and loss of energy to be related to Shingrix.  Additional details were provided as follows: At 1:00 pm, the patient received Shingrix vaccine and by 5:00 pm the patient was experiencing pain at the injection site and extending up to her shoulder and down to the fingertips. By late evening had developed fever, headache and severe pain.  The patient also mentioned that she did not have any energy and ached all over her body. The patient stated that the next day she took advil which eased the pain and that it took a full week to start feeling better. No further AE information was provided.
Age: 73.0
Sex: U
Vaccine: VARZOS
Symptoms: Culture throat, Fatigue, Injection site rash, Pain in extremity, Peripheral swelling
Clinical narrative: I woke up with adore throat; fever; arm swelling; sore arm; rash at site; tired; This case was reported by a consumer via call center representative and described the occurrence of pain in arm in a 73-year-old patient who received Herpes zoster (Shingrix) for prophylaxis.   On 6th March 2020, the patient received the 2nd dose of Shingrix. On 10th March 2020, 4 days after receiving Shingrix, the patient experienced throat irritation. In March 2020, the patient experienced pain in arm, injection site rash, fatigue, fever and swelling arm. On an unknown date, the outcome of the pain in arm, injection site rash, fatigue, fever and swelling arm were unknown and the outcome of the throat irritation was not recovered/not resolved.   It was unknown if the reporter considered the pain in arm, injection site rash, fatigue, throat irritation, fever and swelling arm to be related to Shingrix.  Additional details were provided as follows: The patient arms swelled up, a rash, slight fever, reaching a 100 Fahrenheit, got swabbed, not for corona. The patient reported had regular side effects, sore arm, rash at site and tired.  But this morning (day of reporting) woke up with adore throat.  The reporter wanted to know could it be another effect, or should he/she contact primary care physician.
Age: 73.0
Sex: U
Vaccine: VARZOS
Symptoms: Pyrexia, Throat irritation
Clinical narrative: I woke up with adore throat; fever; arm swelling; sore arm; rash at site; tired; This case was reported by a consumer via call center representative and described the occurrence of pain in arm in a 73-year-old patient who received Herpes zoster (Shingrix) for prophylaxis.   On 6th March 2020, the patient received the 2nd dose of Shingrix. On 10th March 2020, 4 days after receiving Shingrix, the patient experienced throat irritation. In March 2020, the patient experienced pain in arm, injection site rash, fatigue, fever and swelling arm. On an unknown date, the outcome of the pain in arm, injection site rash, fatigue, fever and swelling arm were unknown and the outcome of the throat irritation was not recovered/not resolved.   It was unknown if the reporter considered the pain in arm, injection site rash, fatigue, throat irritation, fever and swelling arm to be related to Shingrix.  Additional details were provided as follows: The patient arms swelled up, a rash, slight fever, reaching a 100 Fahrenheit, got swabbed, not for corona. The patient reported had regular side effects, sore arm, rash at site and tired.  But this morning (day of reporting) woke up with adore throat.  The reporter wanted to know could it be another effect, or should he/she contact primary care physician.
Sex: U
Vaccine: VARZOS
Symptoms: Hypersensitivity, Pyrexia, Vaccine positive rechallenge
Clinical narrative: Possible allergic reaction; had shot #2 of the shingrix vaccine and am experiencing fever like / Fever is only 100.1; This case was reported by a consumer via call center representative and described the occurrence of allergic reaction in a adult patient who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included Shingrix with an associated reaction of pyrexia (1st dose received few months before 2nd dose, refer linked case US2020AMR044130).   On 9th March 2020, the patient received the 2nd dose of Shingrix. In March 2020, less than a week after receiving Shingrix, the patient experienced fever. On an unknown date, the patient experienced allergic reaction. Rechallenge with Shingrix was positive. On an unknown date, the outcome of the allergic reaction and fever were unknown.   It was unknown if the reporter considered the allergic reaction and fever to be related to Shingrix.  Additional details were provided as follows: The age at vaccination was not reported. The age group of patient was not reported but was captured as an adult as per vaccine indication. A day before reporting, the patient received 2nd dose of Shingrix, and experienced fever. The fever was 100.1 Degree F. The patient asked that he/she should considered it as an allergic reaction or not. The patient did not had any other issue just had fever.
Sex: U
Vaccine: VARZOS
Symptoms: Hypersensitivity, Pyrexia
Clinical narrative: Possible allergic reaction; i am experiencing fever like I did with first one a few months ago; This case was reported by a consumer via call center representative and described the occurrence of allergic reaction in a adult patient who received Herpes zoster (Shingrix) for prophylaxis.   On an unknown date, the patient received the 1st dose of Shingrix. On an unknown date, Less than 6 months after receiving Shingrix, the patient experienced allergic reaction and fever. On an unknown date, the outcome of the allergic reaction and fever were unknown.   It was unknown if the reporter considered the allergic reaction and fever to be related to Shingrix.  Additional details were provided as follows: The age at vaccination was not reported. The age group of patient was not reported but was captured as an adult as per vaccine indication. Few months ago before reporting, the patient received 1st dose of Shingrix and experienced fever. The patient asked that he/she should considered it as an allergic reaction or not as same event occurred after 2nd dose. The patient did not had any other issue just had fever. For tolerance with 2nd diose of Shingrix, refer linked case US2020AMR044117.
Age: 72.0
Sex: U
Vaccine: VARZOS
Symptoms: Chills, Myalgia, Pyrexia
Clinical narrative: fever of 100,4; chills; muscle aches; This case was reported by a consumer via call center representative and described the occurrence of fever in a 72-year-old patient who received Herpes zoster (Shingrix) for prophylaxis.   On 9th March 2020, the patient received Shingrix. In March 2020, less than a day after receiving Shingrix, the patient experienced fever, chills and muscle pain. On an unknown date, the outcome of the fever, chills and muscle pain were not recovered/not resolved.   It was unknown if the reporter considered the fever, chills and muscle pain to be related to Shingrix.  Additional details were provided as follows: A day before reporting at 5:30, the patient received Shingrix. On 10th March 2020, the symptoms like fever with chills and muscle pain started. At the time of reporting, the patient had a fever of 100.4 Degree F. The medical assistant informed patient that the majority of solicited local adverse reactions and general adverse events seen with Shingrix had a median duration of 2 to 3 days and recommended patient to speak with your healthcare provider.
Sex: U
Vaccine: VARZOS
Symptoms: Chills, Headache, Nausea, Pyrexia
Clinical narrative: Fever about 100 degrees F; chills; headache; nausea; This case was reported by a consumer and described the occurrence of fever in a patient who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included Shingrix (1st dose received on an unknown date).   On an unknown date, the patient received the 2nd dose of Shingrix. On an unknown date, unknown after receiving Shingrix, the patient experienced fever, chills, headache and nausea. On an unknown date, the outcome of the fever, chills, headache and nausea were unknown.   It was unknown if the reporter considered the fever, chills, headache and nausea to be related to Shingrix.  Additional information was provided as follows: The age at vaccination was not reported. The patient received both doses of Shingrix vaccine and experinced fever of 100 degrees.      Lab Comments: On an unknown date, the lab test was perform
Sex: U
Vaccine: VARZOS
Symptoms: Feeling abnormal, Heart rate increased, Pyrexia
Clinical narrative: I experienced a rapid heartbeat; high fever; felt horrible; This case was reported by a consumer via call center representative and described the occurrence of heart rate increased in a adult patient who received Herpes zoster (Shingrix) for prophylaxis.   On an unknown date, the patient received the 1st dose of Shingrix. On an unknown date, unknown after receiving Shingrix, the patient experienced heart rate increased, fever and feels awful. On an unknown date, the outcome of the heart rate increased, fever and feels awful were unknown.   It was unknown if the reporter considered the heart rate increased, fever and feels awful to be related to Shingrix.  Additional information was provided as follows: The age at vaccination was not reported. The age group was captured as an adult as per vaccine indication. The patient wanted to know whether should he/she get the second dose, when experienced a rapid heartbeat, high fever, and felt horrible after the first dose.
Age: 71.0
Sex: U
Vaccine: VARZOS
Symptoms: Chills, Headache, Influenza like illness, Myalgia
Clinical narrative: felt like the flu; Muscle pains; Headache; Shivering and chills; This case was reported by a consumer via call center representative and described the occurrence of influenza-like symptoms in a 71-year-old patient who received Herpes zoster (Shingrix) for prophylaxis.   On 17th December 2019, the patient received the 1st dose of Shingrix. On 17th December 2019, 8 hrs after receiving Shingrix, the patient experienced influenza-like symptoms, muscle pain, headache and chills. On 20th December 2019, the outcome of the influenza-like symptoms, muscle pain, headache and chills were recovered/resolved.   It was unknown if the reporter considered the influenza-like symptoms, muscle pain, headache and chills to be related to Shingrix.  Additional details were reported as follows: This case was reported by patient itself. The patient received vaccine and had influenza-like symptoms, muscle pain, headache, shivering and chills. The patient wanted to know whether it will happened again after receiving 2nd dose. No other information was reported.
Sex: F
Vaccine: VARZOS
Symptoms: Feeling cold, Headache, Pain, Pyrexia, Tremor
Clinical narrative: I had a fever over 100°/ my body was burning hot; terrible shaking and trembling; was freezing cold but; All over body aches; headache; This case was reported by a consumer via call center representative and described the occurrence of fever in a elderly female patient who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included Shingrix with an associated reaction of adverse drug reaction (1st dose received on an unknown date, refer case US2020AMR055456).   On an unknown date, the patient received the 2nd dose of Shingrix. On an unknown date, less than a day after receiving Shingrix, the patient experienced fever, tremor, feeling cold, general body pain and headache. On an unknown date, the outcome of the fever was recovering/resolving and the outcome of the tremor and feeling cold were unknown and the outcome of the general body pain was not recovered/not resolved and the outcome of the headache was recovered/resolved.   It was unknown if the reporter considered the fever, tremor, feeling cold, general body pain and headache to be related to Shingrix.  Additional information was provided as follows: The age at vaccination was not reported. The patient reported that she just received 2nd dose of Shingrix. The patient experienced fever over 100 degree F, terrible shaking and trembling within 10 hours of receiving vaccine. The patient was freezing cold but her husband said her body was burning hot.  All over body aches and headache. The fever had subsided somewhat, body aches continued, headache was better. The patient had enough with her first injection.Her husband did not experience this at all.      Lab Comments: On an unknown date, the lab test was perform
Sex: U
Vaccine: VARZOS
Symptoms: Pain in extremity
Clinical narrative: arm pain; This case was reported by a consumer via call center representative and described the occurrence of pain in arm in a adult patient who received Herpes zoster (Shingrix) for prophylaxis.   On 12th March 2020, the patient received Shingrix. On 12th March 2020, less than a day 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.   It was unknown if the reporter considered the pain in arm to be related to Shingrix.  Additional information was provided as follows: The age at vaccination was not reported. The age group was captured as an adult as per vaccine indication. The patient wanted to know, what was best to take Aspirin or Tylenol for arm pain.
Age: 77.0
Sex: U
Vaccine: VARZOS
Symptoms: Chills, Headache, Pyrexia
Clinical narrative: Fever; shivers; severe headache; This case was reported by a consumer via call center representative and described the occurrence of shivers in a 77-year-old patient who received Herpes zoster (Shingrix) for prophylaxis.   On 13th March 2020, the patient received Shingrix. In March 2020, less than a week after receiving Shingrix, the patient experienced shivers and headache. On 16th March 2020, the patient experienced fever. On an unknown date, the outcome of the shivers, headache and fever were not recovered/not resolved.   It was unknown if the reporter considered the shivers, headache and fever to be related to Shingrix.  Additional details were reported as follows: The patient received Shingrix and had the shivers and a severe headache. On 16th March 2020 had a fever.  Patient enquired for can the reaction to it last this long?
Sex: U
Vaccine: VARZOS
Symptoms: Paraesthesia, Rash macular, Rash pruritic
Clinical narrative: little jolts of itching / had 2or 3 itchy pattern spots /nerve itching; also had pattern spots in areas that went away; feels like jolts of tingling; This case was reported by a consumer via call center representative and described the occurrence of itchy rash in a adult patient who received Herpes zoster (Shingrix) for prophylaxis.   On an unknown date, the patient received the 1st dose of Shingrix. On an unknown date, unknown after receiving Shingrix, the patient experienced itchy rash, spot-like rash and tingling. On an unknown date, the outcome of the itchy rash and spot-like rash were unknown and the outcome of the tingling was recovered/resolved.   It was unknown if the reporter considered the itchy rash, spot-like rash and tingling to be related to Shingrix.  Additional case details were reported as follows: The age at vaccination was not reported. The patient experienced jolts of itching, had 2or 3 itchy pattern spots and felt like jolts of tingling after vaccination. The patient had not receive the 2nd dose if Shingrix. The patient asked whether there was a need to see the physician.
Sex: U
Vaccine: VARZOS
Symptoms: Pain
Clinical narrative: What medicine do you recommend for aches and pains after getting the shot?; This case was reported by a consumer via interactive digital media and described the occurrence of pain in a adult patient who received Herpes zoster (Shingrix) for prophylaxis.   On an unknown date, the patient received Shingrix at an unknown dose. On an unknown date, unknown after receiving Shingrix, the patient experienced pain. On an unknown date, the outcome of the pain was unknown.   It was unknown if the reporter considered the pain to be related to Shingrix.  Additional case details were reported as follows: This case was reported b patient himself or herself. The age at vaccination was not reported. The age group was not reported but was selected as adult as per vaccine indication. The patient enquired which medicines are recommended for aches and pains after receiving Shingrix.
Sex: U
Vaccine: VARZOS
Symptoms: Influenza like illness
Clinical narrative: Can I have very bad flu like symptoms even 3 days after getting a 2 nd shingles shot?; This case was reported by a consumer via interactive digital media and described the occurrence of influenza-like symptoms in a adult patient who received Herpes zoster (Shingrix) for prophylaxis.   On an unknown date, the patient received the 2nd dose of Shingrix. On an unknown date, 3 days after receiving Shingrix, the patient experienced influenza-like symptoms. On an unknown date, the outcome of the influenza-like symptoms was unknown.   It was unknown if the reporter considered the influenza-like symptoms to be related to Shingrix.  Additional case details were reported as follows: This case was reported b patient himself or herself. The age at vaccination was not reported. The age group was not reported but was selected as adult as per vaccine indication. The patient had very bad flu like symptoms.
Sex: U
Vaccine: VARZOS
Symptoms: Myalgia, Pyrexia
Clinical narrative: how long will the fever last after the shigle shot; how long will the muscle ache last after the shigle shot; This case was reported by a consumer via interactive digital media and described the occurrence of fever in a adult patient who received Herpes zoster (Shingrix) for prophylaxis.   On an unknown date, the patient received Shingrix at an unknown dose. On an unknown date, unknown after receiving Shingrix, the patient experienced fever and muscle pain. On an unknown date, the outcome of the fever and muscle pain were unknown.   It was unknown if the reporter considered the fever and muscle pain to be related to Shingrix.  Additional case details were reported as follows: This case was reported by patient himself or herself. The age at vaccination was not reported. The age group was not reported, but was selected as adult as per vaccine indication. The patient enquired how long would the fever and muscle aches last after Shingrix.
Sex: U
Vaccine: VARZOS
Symptoms: Chills
Clinical narrative: This case was reported by a consumer via call center representative and described the occurrence of shivering in a adult patient who received Herpes zoster (Shingrix) for prophylaxis.   On an unknown date, the patient received Shingrix at an unknown dose. On an unknown date, unknown after receiving Shingrix, the patient experienced shivering. On an unknown date, the outcome of the shivering was unknown.   It was unknown if the reporter considered the shivering to be related to Shingrix.  Additional case 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 reporter made an inquiry about how long do the shivering last after vaccination with Shingrix.
Sex: U
Vaccine: VARZOS
Symptoms: Chills, Nausea, Pain
Clinical narrative: had chills; body aches; nausea; This case was reported by a nurse and described the occurrence of chills in a patient who received Herpes zoster (Shingrix) for prophylaxis.   On 25th April 2020, the patient received the 2nd dose of Shingrix. On 25th April 2020, less than a day after receiving Shingrix, the patient experienced chills, general body pain and nausea. On an unknown date, the outcome of the chills, general body pain and nausea were not recovered/not resolved.   It was unknown if the reporter considered the chills, general body pain and nausea to be related to Shingrix.  Additional information was provided as follows: The age at vaccination was not reported. The patient received the 2nd dose of shingrix and had chills, body aches and nausea the entire evening after the injection.  The reporter was registered nurse and just wanted to relay the information for GlaxoSmithKline product information. The reporter was curious if another booster was needed after these 2 injections. The reporter wanted to know was there any study been done that stated approximately how long this lasts.
Sex: U
Vaccine: VARZOS
Symptoms: Nausea
Clinical narrative: Side effects; Nausea; This case was reported by a consumer and described the occurrence of adverse event in a patient who received Herpes zoster (Shingrix) for prophylaxis.   On an unknown date, the patient received Shingrix at an unknown dose. On an unknown date, unknown after receiving Shingrix, the patient experienced adverse event and nausea. On an unknown date, the outcome of the adverse event and nausea were not recovered/not resolved.   It was unknown if the reporter considered the adverse event and nausea to be related to Shingrix.  Additional information was provided as follows: The age at vaccination was not reported. The patient had all but the nausea. The reporter asked how long would the common side effects of Shingrix last.
Sex: F
Vaccine: RV1
Symptoms: Incomplete course of vaccination, Social problem
Clinical narrative: my child is currently 21weeks but because of the pandemic was not abpe to get Rotarix vaccine it safe to have only one dose; This case was reported by a consumer via call center representative and described the occurrence of social problem in a 5-month-old female patient who received Rota (Rotarix) for prophylaxis.   Previously administered products included Rotarix (received 1st dose on an unknown date).   On an unknown date, the patient received the 2nd dose of Rotarix (oral). On an unknown date, unknown after receiving Rotarix, the patient experienced social problem. On an unknown date, the outcome of the social problem was unknown.  Additional details were received as follows: The age at vaccination was not applicable for this report. The reporter stated that the patient because of the pandemic was not able to get Rotarix vaccine is it safe to have only one dose and are there any risks. The reporter asked is it not recommended to get only one dose.
Sex: U
Vaccine: VARZOS
Symptoms: Chills, Erythema, Fatigue, Induration
Clinical narrative: redness; induration; chills; fatigue; This case was reported by a consumer and described the occurrence of erythema in a patient who received Herpes zoster (Shingrix) for prophylaxis.   In April 2020, the patient received the 2nd dose of Shingrix. In April 2020, less than a day after receiving Shingrix, the patient experienced erythema, induration, chills and fatigue. On an unknown date, the outcome of the erythema was not recovered/not resolved and the outcome of the induration, chills and fatigue were unknown.   It was unknown if the reporter considered the erythema, induration, chills and fatigue to be related to Shingrix.  Additional information was provided as follows: The age at vaccination was not reported. The patient received shringrix 24 hours ago and the redness, induration has increased to 7cm and also experienced 2 episodes of chills and fatigue. The reporter was concerned when should be concerned. The reporter wanted to know when should he/she expect the redness to resolve.
Sex: U
Vaccine: FLUX
Symptoms: Adverse event
Clinical narrative: Severe reaction; This case was reported by a consumer and described the occurrence of adverse event in a patient who received Flu Seasonal QIV Dresden (Influenza vaccine Quadrivalent unspecified season) for prophylaxis.   Previously administered products included prevnar 13 with an associated reaction of nonspecific reaction (put the patient in an ICU for 5 days and another 5 days in step down units.).   On an unknown date, the patient received Influenza vaccine Quadrivalent unspecified season at an unknown dose. On an unknown date, unknown after receiving Influenza vaccine Quadrivalent unspecified season, the patient experienced adverse event. On an unknown date, the outcome of the adverse event was unknown.   It was unknown if the reporter considered the adverse event to be related to Influenza vaccine Quadrivalent unspecified season.  Additional information was provided as follows: The age at vaccination was not reported. The patient had severe reactions to shots and Prevnar 13 put me in an ICU for 5days.  The patient also spent another 5 days in step down units. The patient reacted to GlaxoSmithKline garden variety flu shot every year. The reporter finally changed physician and was told the truth about what was going on. The reporter asked GlaxoSmithKline about getting these shots. The reporter was terrified of getting any shots.
Sex: U
Vaccine: FLUX
Symptoms: Adverse event
Clinical narrative: Every time I got a flu gab I actually got worse so no thanks; This case was reported by a consumer via interactive digital media and described the occurrence of adverse event in a patient who received Flu Seasonal QIV Dresden (Influenza vaccine Quadrivalent unspecified season) for prophylaxis.   On an unknown date, the patient received Influenza vaccine Quadrivalent unspecified season at an unknown dose. On an unknown date, unknown after receiving Influenza vaccine Quadrivalent unspecified season, the patient experienced adverse event. On an unknown date, the outcome of the adverse event was unknown.   It was unknown if the reporter considered the adverse event to be related to Influenza vaccine Quadrivalent unspecified season.  Additional case details were reported as follows: The age at vaccination was not reported. The patient stated that every time get flu vaccine actually got worse. The patient stated that the covid-19 killing thousands of dear dear loved ones.
Sex: M
Vaccine: MNQ
Symptoms: Poisoning
Clinical narrative: poisoned my son; This case was reported by a consumer via interactive digital media and described the occurrence of poisoning in a male patient who received Men ACWY-CRM NVS (Meningitis ACWY vaccine (potential Menveo)) for prophylaxis.   On an unknown date, the patient received Meningitis ACWY vaccine (potential Menveo) at an unknown dose. On an unknown date, unknown after receiving Meningitis ACWY vaccine (potential Menveo), the patient experienced poisoning (serious criteria GSK medically significant). On an unknown date, the outcome of the poisoning was unknown.   It was unknown if the reporter considered the poisoning to be related to Meningitis ACWY vaccine (potential Menveo).  Additional details were provided as follows: The age at vaccination was not reported. The patient's mother reported that, after receiving Meningitis, the patient was poisened.