chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 1.0
Sex: M
Vaccine: MMRV
Symptoms: Product storage error
Clinical narrative: no further AE; temperature excursion; PROQUAD no longer viable; This spontaneous report was received from a nurse referring to a 13 months old male patient. The patient's medical history, concomitant drugs and drug allergies were not reported.   On 25-JAN-2021, the patient was vaccinated with measles, mumps, rubella and varicella (oka-merck) virus vaccine live (PROQUAD) (lot # T003714, expiration date was not reported, but upon internal validation established as 29-JUL-2021, strength was not reported) 0.5 milliliter subcutaneously for prophylaxis.   It was reported that the office was closed due to coronavirus disease (COVID), and the freezer had gone out of range. The temperature excursion of these vaccine was 47 degrees Fahrenheit for approximate 9 hours and 54 minutes without any previous temperature excursion. The digital data logger was involved for measles, mumps, rubella and varicella (oka-merck) virus vaccine live (PROQUAD). It was also reported that the measles, mumps, rubella and varicella (oka-merck) virus vaccine live (PROQUAD) was no longer viable. No further adverse event was reported.
Sex: F
Vaccine: VARZOS
Symptoms: Herpes zoster, Hypersensitivity, Malaise, Pyrexia, Rash
Clinical narrative: severe allergic reaction/very ill and having a fever; shingles type rash; This spontaneous report was received from a currently 61-year-old female patient referring to herself. The patient's pertinent medical history included low thyroid. Concomitant medication included levothyroxine sodium (reported as levothyroxine). The patient had a lot of allergies.   On an unknown date in 2014, the patient was vaccinated with zoster vaccine live (ZOSTAVAX) (dose, strength, lot# and expiration date was not provided; route reported as injection) for shingles.     On an unknown date in 2014, the patient experienced a "severe allergic reaction", felt very ill and had a fever (hypersensitivity) and shingles type rash (herpes zoster). There was no lab diagnostics/studies performed. The patient did not seek medical attention. The outcome of hypersensitivity and herpes zoster was reported as recovered on an unknown date in 2014.  The causality assessment between the events and zoster vaccine live (ZOSTAVAX) was not provided.
Age: 18.0
Sex: F
Vaccine: HPV9
Symptoms: Exposure during pregnancy, No adverse event, Pregnancy test positive
Clinical narrative: After administration of the vaccine, the patient was found to be pregnant; no adverse event; This spontaneous pregnancy report was received from a medical assistant referring to an 18 year old female patient.    The patient had no pertinent medical history or drug reactions/allergies.  Concomitant therapies included ibuprofen and loratadine.   On 10-FEB-2021, the patient went to the medical center for birth control management, and it was noticed that she was due for the  hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast)(GARDASIL 9) vaccine. The medical assistant administered the dose of with hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast)(GARDASIL 9) pre-filled syringe, lot # 1621929, expiring on 06-DEC-2021, intramuscularly.  Then a pregnancy test was taken and the patient was found to be pregnant.  The last menstrual period and estimated due date were unknown.  The pregnacy was ongoing at the time of reporting.  No additional adverse event or product quality issues 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.; devicelotnumber: 1621929; expirationdate: 06-DEC-2021; deviceage and unit: 0 ; malfunction: Unknown; deviceusage: Initial; reasonfornoneval: 81 Other; labeledsingleusedevice: No; mdcpreportability: No; mdcpreprationale: Case information does not suggest a causal association with the device or device constituent
Sex: M
Vaccine: BCG
Symptoms: Product availability issue
Clinical narrative: That same test suggested he use BCG VACCINE as a treatment for fibromyalgia; patients wife states she knows the HCP will write the prescription for him.; unable to find BCG VACCINE anywhere; This spontaneous report was received from a patient's wife and refers to a male patient of unknown age. There was no information about the patient's concurrent conditions, concomitant therapies or medical history provided.      On an unknown date, the patient had a test done (name of test was not provided) for fibromyalgia and he was "unequivocally positive for fibromyalgia". That same test suggested that he use bcg live (BCG VACCINE USP) (dose, route of administration, anatomical location, lot # and expiration date were not reported) as a treatment for fibromyalgia (product use in unapproved indication). The reporter stated she knew the healthcare professional (HCP) would write the prescription for him (circumstance or information capable of leading to medication error). It was also reported that the patient was unable to find bcg live (BCG VACCINE USP) anywhere (product availability issue). combinationproductreport: Yes; brandname: BCG VACCINE USP PUNCTURE DEVICE (DEVICE); commondevicename: BCG live; productcode: LDH; devicetype: SYSTEM, DELIVERY, ALLERGEN AND VACCINE (LDH); manufacturername: Organon Teknika Corporation LLC; deviceage and unit: 0 ; malfunction: Unknown; deviceusage: Initial; reasonfornoneval: 81 Other; labeledsingleusedevice: No; mdcpreportability: No; mdcpreprationale: Case information does not suggest a causal association with the device or device constituent
Sex: F
Vaccine: VARZOS
Symptoms: Rash, Rash vesicular
Clinical narrative: varicella type rashes under her breast and spread throughout her body; Information was received from a lawyer regarding a case in litigation referring to a female patient (pt) of unknown age. Information regarding concomitant medication, current condition or historical condition was unknown. On or around 11-JUL-2014, the pt was inoculated with zoster vaccine live (ZOSTAVAX) (strength, dose number, route, batch/lot# and expiration date were unknown) for routine health maintenance and for its intended purpose: the prevention of shingles (herpes zoster). On an unknown date, shortly after receiving zoster vaccine live (ZOSTAVAX), the pt suffered varicella type rashes under her breast and spread throughout her body. As a direct and proximate result of zoster vaccine live (ZOSTAVAX), the pt's symptoms had resulted in physical limitations not presented prior to using zoster vaccine live (ZOSTAVAX). The pt also experienced mental and emotional distress due to resulting physical limitations and seriousness of her condition. As a result of the manufacture, marketing, advertising, promotion, distribution and/or sale of zoster vaccine live (ZOSTAVAX), the pt sustained severe and permanent personal injuries. Further, as a tragic consequence of the company's wrongful conduct, the 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 the company's conduct, the pt had suffered and incurred damages, including medical expenses; the loss of accumulations; and other economic and non-economic damages. The outcome of the event was considered as not recovered. The reporter considered varicella type rashes to be related to zoster vaccine live (ZOSTAVAX).     The event of varicella type rashes was considered as disabling.
Sex: F
Vaccine: HPV4, HPV9
Symptoms: Cervical dysplasia, Human papilloma virus test positive, Inappropriate schedule of product administration, Papilloma viral infection, Smear cervix abnormal
Clinical narrative: the patient's mother claimed that the patient had 2 doses of the "HPV vaccine", 1st dose at 13 years of age and 2nd dose at 15 years of age.; HCP provided patient history of abnormal Pap smear in 2019 that was positive for HPV and "ASCUS./HCP reported the patient came back to their office in July 2020 for another Pap smear which was again positive for HPV; in July 2020 for another Pap smear which was again positive for HPV and "ASCUS"/in September 2020 and results showed a "low grade squamous intra-epithelial lesion CIN 1 on all 3 biopsies."; This spontaneous report was received from a medical assistant, referring to a 26-year-old female patient. The patient's pertinent medical history and concomitant medications were not reported. Her current conditions included "heavy smoker, 20-39 cigarettes per day", and the patient has no known drug allergies.   On unknown dates, at the age of 13 and 14-year-old the patient was vaccinated with the first and second dose, respectively of quadrivalent human papillomavirus (types 6,11,16,18) recomb. vaccine (GARDASIL) or hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast) (GARDASIL 9), both vaccines were administered as prophylaxis (formulations, strengths, doses, routes of administration, anatomical sites of vaccination, lot numbers and expiration dates were not reported) (inappropriate schedule of product administration).   The reporter stated that, the patient had history of abnormal Papanicolaou (PAP) smear in 2019, it was positive for human papilloma virus infection (HPV) and atypical squamous cells of undetermined significance (ASCUS) (papilloma viral infection and cervical dysplasia), and negative for 16, 18 and 45 genotype. The medical assistant reported that, the patent did not return for further testing as recommended after this result.   In July 2020, the patient came back to their office for another PAP smear, which was again positive for HPV and ASCUS (papilloma viral infection and cervical dysplasia), and negative for 16, 18 and 45 genotype.   In September 2020, the patient was underwent a colposcopy and the results showed "a "low grade squamous intra-epithelial lesion CIN 1 on all 3 biopsies."  The outcome of papilloma viral infection and cervical dysplasia, was not recovered. The causality assessment between quadrivalent human papillomavirus (types 6,11,16,18) recomb. vaccine (GARDASIL) and hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast) (GARDASIL 9) with the aforementioned events were not reported.
Sex: U
Vaccine: VARZOS
Symptoms: Fatigue, Headache, Pain in extremity
Clinical narrative: headache; sore arm; fatigue; This case was reported by a consumer via other manufacturer and described the occurrence of headache 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 headache, pain in arm and fatigue. On an unknown date, the outcome of the headache, pain in arm and fatigue were recovered/resolved.   It was unknown if the reporter considered the headache, pain in arm and fatigue to be related to Shingrix.  Additional details were provided as follows: The age group was not reported, however it was captured as an adult as per vaccine indication. The age at vaccination was not reported. The patient had issue with the vaccine and experienced sore arm, fatigue and headache. This case has been linked with US2021AMR001169 reported by same reporter, same patient.; Sender's Comments:  US-GLAXOSMITHKLINE-US2021AMR001169:Tdap vaccine, same patient
Sex: U
Vaccine: VARZOS
Symptoms: Rash
Clinical narrative: rash following Shingrix shot; This case was reported by a consumer and described the occurrence of rash 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 rash. On an unknown date, the outcome of the rash was unknown.   It was unknown if the reporter considered the rash 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 rash. The reporter looking for information on rash following Shingrix shot.
Sex: U
Vaccine: VARZOS
Symptoms: Dizziness, Nausea
Clinical narrative: Dizziness; Nausea; This case was reported by a consumer and described the occurrence of dizziness in a adult patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   On an unknown date, the patient received Shingles vaccine. On an unknown date, unknown after receiving Shingles vaccine, the patient experienced dizziness and nausea. On an unknown date, the outcome of the dizziness and nausea were unknown.   It was unknown if the reporter considered the dizziness and nausea to be related to Shingles vaccine.  Additional details were reported as follows: The age at vaccination was not reported. The patient received shingles vacckine and experinced dizziness and nausea. The patient asked how long the side effects last and can do anything to minimize the side effects.
Sex: F
Vaccine: VARZOS
Symptoms: Injection site pruritus
Clinical narrative: experienced some slight itching; This case was reported by a consumer and described the occurrence of injection site itching in a female patient who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included Shingrix with an associated reaction of injection site pruritus (received 1st dose on unknown date, refer case US2021026215). Concurrent medical conditions included drug hypersensitivity (to Depo-Medrol).   On an unknown date, the patient received the 2nd dose of Shingrix. On an unknown date, 1 day after receiving Shingrix, the patient experienced injection site itching. Rechallenge with Shingrix was positive. On an unknown date, the outcome of the injection site itching was recovered/resolved.   The reporter considered the injection site itching to be related to Shingrix.  Additional details were reported as follows: The age at vaccination was not reported. The patient could not remember the exact dates of when she received the vaccine but believed it to be last year or possibly 2019. The patient experienced some slight itching the following day that lasted several weeks and experienced no other reactions.   Did not consent to follow up.; Sender's Comments:  US-GLAXOSMITHKLINE-US2021026215:same reporter
Sex: F
Vaccine: VARZOS
Symptoms: Herpes zoster
Clinical narrative: Shingles after getting Shingrix vaccine two weeks ago; This case was reported by a consumer and described the occurrence of shingles in a 50-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   In January 2021, the patient received Shingrix. On an unknown date, less than 2 weeks after receiving Shingrix and an unknown time after starting Valacyclovir, the patient experienced shingles. The patient was treated with valaciclovir hydrochloride (Valacyclovir). On an unknown date, the outcome of the shingles was unknown.   It was unknown if the reporter considered the shingles to be related to Shingrix.  Additional details were provided as follows: The age at vaccination was not reported. The patient had shingles after getting Shingrix vaccine two weeks ago. The primary care physician said that it rare and prescribed me Valacyclovir 1000 mg every 8 hours for 7 days.
Sex: U
Vaccine: VARZOS
Symptoms: Pain in extremity
Clinical narrative: arm hurt in cold weather; This case was reported by a consumer and described the occurrence of pain in arm 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 pain in arm. On an unknown date, the outcome of the pain in arm was unknown.   It was unknown if the reporter considered the pain in arm to be related to 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. In 2019, the patient received Shingrix and had pain arm. The patient took cough medicine later right arm hurt in cold weather.
Sex: F
Vaccine: VARZOS
Symptoms: Back pain, Injection site pain, Pain in extremity
Clinical narrative: Has had sharp back / pain / not resolved; Right leg pain / not resolved; This case was reported by a consumer and described the occurrence of back pain in a female patient who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included Shingrix with an associated reaction of injection site pain (received 1st dose on 6th November 2020, refer case US2021032748).   On 25th January 2021, the patient received the 2nd dose of Shingrix. On an unknown date, less than 2 weeks after receiving Shingrix, the patient experienced back pain and leg pain. On an unknown date, the outcome of the back pain and leg pain were not recovered/not resolved.   It was unknown if the reporter considered the back pain and leg pain to be related to Shingrix.  Additional details were provided as follows: The patient received Shingrix and had sharp back and right leg pain.  It had not resolved and would follow up with HCP.  The reporter could not find HCP contact information during call, it was not obtained for that reason. The reporter did not consent to followup.; Sender's Comments:  US-GLAXOSMITHKLINE-US2021032748:Same reporter.
Sex: F
Vaccine: VARZOS, VARZOS
Symptoms: Bell's palsy, Ear pain, Facial paralysis, Headache, Hypoaesthesia
Clinical narrative: Headaches; Ear pain; Lots of other nerve pain in my hands and legs; Inappropriate age at vaccine administration; My face started drooping / diagnosed me with Bell's palsy; Numbness in my face; This case was reported by a consumer and described the occurrence of bell's palsy in a 35-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   Co-suspect products included Herpes zoster (Shingrix) for prophylaxis.   On an unknown date, the patient received the 1st dose of Shingrix and the 2nd dose of Shingrix. In November 2020, not applicable after receiving Shingrix and 3 weeks after receiving Shingrix, the patient experienced numbness facial. On an unknown date, the patient experienced bell's palsy (serious criteria GSK medically significant), headache, ear pain, nerve pain and inappropriate age at vaccine administration. The patient was treated with antivirals nos and steroids nos (Steroids). On an unknown date, the outcome of the bell's palsy, numbness facial, headache, ear pain and nerve pain were not recovered/not resolved and the outcome of the inappropriate age at vaccine administration was unknown.   It was unknown if the reporter considered the bell's palsy, numbness facial, headache, ear pain and nerve pain to be related to Shingrix.  Additional details were provided as follows: The patient had reported the case for herself. The age at vaccination was not reported for the 1st dose and it could be 34 or 35 year for 2nd dose of Shingrix. The patient received 1st and 2nd dose of Shingrix before 50 years of age, which led to inappropriate age at vaccine administration. The patient started having numbness in her face about 3 weeks November 2020 after 2nd dose of shingrix, a couple weeks later her face started drooping and she had headaches and ear pain.  The patient was diagnosed me with Bell's palsy 2 months after 2nd dose. At the time of reporting, the patient was at 3 months post 2nd dose and have gone through two rounds of steroids and antivirals and symptoms were came back with lots of other nerve pain in her hands and legs. The consent to follow-up was requested.
Sex: F
Vaccine: VARZOS, VARZOS
Symptoms: Neuralgia, Pain in extremity, Product administered to patient of inappropriate age
Clinical narrative: Headaches; Ear pain; Lots of other nerve pain in my hands and legs; Inappropriate age at vaccine administration; My face started drooping / diagnosed me with Bell's palsy; Numbness in my face; This case was reported by a consumer and described the occurrence of bell's palsy in a 35-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   Co-suspect products included Herpes zoster (Shingrix) for prophylaxis.   On an unknown date, the patient received the 1st dose of Shingrix and the 2nd dose of Shingrix. In November 2020, not applicable after receiving Shingrix and 3 weeks after receiving Shingrix, the patient experienced numbness facial. On an unknown date, the patient experienced bell's palsy (serious criteria GSK medically significant), headache, ear pain, nerve pain and inappropriate age at vaccine administration. The patient was treated with antivirals nos and steroids nos (Steroids). On an unknown date, the outcome of the bell's palsy, numbness facial, headache, ear pain and nerve pain were not recovered/not resolved and the outcome of the inappropriate age at vaccine administration was unknown.   It was unknown if the reporter considered the bell's palsy, numbness facial, headache, ear pain and nerve pain to be related to Shingrix.  Additional details were provided as follows: The patient had reported the case for herself. The age at vaccination was not reported for the 1st dose and it could be 34 or 35 year for 2nd dose of Shingrix. The patient received 1st and 2nd dose of Shingrix before 50 years of age, which led to inappropriate age at vaccine administration. The patient started having numbness in her face about 3 weeks November 2020 after 2nd dose of shingrix, a couple weeks later her face started drooping and she had headaches and ear pain.  The patient was diagnosed me with Bell's palsy 2 months after 2nd dose. At the time of reporting, the patient was at 3 months post 2nd dose and have gone through two rounds of steroids and antivirals and symptoms were came back with lots of other nerve pain in her hands and legs. The consent to follow-up was requested.
Age: 60.0
Sex: F
Vaccine: VARZOS
Symptoms: Bed rest, Chills, Fatigue, Lymphadenopathy, Pain
Clinical narrative: unexpected benefit alleviation of chronic all over body pain, especially in the hands; swollen glands; fatigue; chills; fever; This case was reported by a consumer and described the occurrence of swollen glands in a 60-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   Concurrent medical conditions included genital herpes (25 year history) and chronic pain (chronic all over body). Concomitant products included valaciclovir hydrochloride (Valacyclovir).   On 2nd January 2021, the patient received the 2nd dose of Shingrix. On 3rd January 2021, 1 days after receiving Shingrix, the patient experienced swollen glands, fatigue, chills and fever. On 4th January 2021, the patient experienced unexpected therapeutic effect. The patient was treated with paracetamol (Tylenol). In January 2021, the outcome of the fever was recovered/resolved. On an unknown date, the outcome of the swollen glands, fatigue, chills and unexpected therapeutic effect were unknown.   It was unknown if the reporter considered the swollen glands, fatigue, chills, fever and unexpected therapeutic effect to be related to Shingrix.  Additional details were provided as follows: The patient was using valacyclovir as treatment for genital herpes. The patient developed fever, chills, swollen glands and fatigue and self treated with Tylenol and bed rest. Two days later the patient experienced the unexpected benefit alleviation of chronic all over body pain, especially in the hands. The reporter consented to follow up.
Age: 60.0
Sex: F
Vaccine: VARZOS
Symptoms: Pain in extremity, Peripheral swelling, Pyrexia, Therapeutic response unexpected
Clinical narrative: unexpected benefit alleviation of chronic all over body pain, especially in the hands; swollen glands; fatigue; chills; fever; This case was reported by a consumer and described the occurrence of swollen glands in a 60-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   Concurrent medical conditions included genital herpes (25 year history) and chronic pain (chronic all over body). Concomitant products included valaciclovir hydrochloride (Valacyclovir).   On 2nd January 2021, the patient received the 2nd dose of Shingrix. On 3rd January 2021, 1 days after receiving Shingrix, the patient experienced swollen glands, fatigue, chills and fever. On 4th January 2021, the patient experienced unexpected therapeutic effect. The patient was treated with paracetamol (Tylenol). In January 2021, the outcome of the fever was recovered/resolved. On an unknown date, the outcome of the swollen glands, fatigue, chills and unexpected therapeutic effect were unknown.   It was unknown if the reporter considered the swollen glands, fatigue, chills, fever and unexpected therapeutic effect to be related to Shingrix.  Additional details were provided as follows: The patient was using valacyclovir as treatment for genital herpes. The patient developed fever, chills, swollen glands and fatigue and self treated with Tylenol and bed rest. Two days later the patient experienced the unexpected benefit alleviation of chronic all over body pain, especially in the hands. The reporter consented to follow up.
Age: 78.0
Sex: M
Vaccine: VARZOS
Symptoms: Rash papular, Rash pruritic, Urticaria
Clinical narrative: itchy bothersome rash/hives; itchy bothersome rash/hives; little red bumps all over his back, legs, arm, and chest.; This case was reported by a consumer and described the occurrence of itchy rash in a 78-year-old male patient who received Herpes zoster (Shingrix) for prophylaxis.   Concurrent medical conditions included dry skin (every winter gets dry skin from taking hot showers) and pruritus (had some itching on his back before he got the shingles shot, but no rash).   On 17th November 2020, the patient received the 1st dose of Shingrix. On an unknown date, immediately after receiving Shingrix, the patient experienced itchy rash, hives and erythropapular rash. The patient was treated with prednisone. On an unknown date, the outcome of the itchy rash and erythropapular rash were not recovered/not resolved and the outcome of the hives was unknown.   It was unknown if the reporter considered the itchy rash, hives and erythropapular rash to be related to Shingrix.  Additional information was provided as follows: The patient received of Shingrix and developed an itchy bothersome rash and hives, little red bumps all over his back, legs, arm, and chest. The rash was not on his neck or head. The patient visited his regular doctor and was prescribed Prednisone 5 mg one tablet per day for 7 days. The patient mentioned that, this prescription did not do much. Around 7th December 2020, the patient visited a dermatologist and was prescribed with Prednisone 10 mg which eliminated the rash after 3 weeks. About 4 days after discontinuing the tablets, the rash reappeared. The patient had called the dermatologist and asked for more prednisone and was told that another prescription for prednisone had been phoned in for him. The patient was planning on picking up the prescription on the day of reporting. The reporter went online to see what the possible side effects were of Shingrix and that he didn't get any of them except rash or hives. The reporter stated that every winter he gets dry skin from taking hot showers and he stated that he did have some itching on his back before he got the shingles shot, but no rash. The reporter did not consent to follow up.
Sex: F
Vaccine: VARZOS
Symptoms: Malaise, Pyrexia
Clinical narrative: Got sick; Got / feverish; This case was reported by a consumer and described the occurrence of sickness in a elderly female patient who received Herpes zoster (Shingrix) for prophylaxis.   On an unknown date, the patient received the 2nd dose of Shingrix. On an unknown date, unknown after receiving Shingrix, the patient experienced sickness and fever. On an unknown date, the outcome of the sickness and fever were unknown.   It was unknown if the reporter considered the sickness and fever to be related to Shingrix.  Additional details were provided as follows: The patient's daughter called and reported the case. The age at vaccination was not reported. The patient received Shingrix and got sick and feverish. The lot number unknown to caller. The reporter did not consent to follow up.  This case linked with US2021004404 and US2021AMR005804, reported by same reporter.; Sender's Comments:  US-GLAXOSMITHKLINE-US2021004404:Same reporter US-GLAXOSMITHKLINE-US2021AMR005804:Same reporter
Sex: U
Vaccine: VARZOS
Symptoms: Chills, Fatigue, Pain, Pyrexia, Swelling
Clinical narrative: fatigue; swelling; vomiting; pain; chilis; fever; This case was reported by a physician and described the occurrence of fatigue 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 2 months after receiving Shingrix, the patient experienced fatigue, swelling, vomiting, pain, chills and fever. On an unknown date, the outcome of the fatigue, swelling, vomiting, pain, chills and fever were recovered/resolved.   It was unknown if the reporter considered the fatigue, swelling, vomiting, pain, chills and fever to be related to Shingrix.  Additional details were provided as follows: The age at vaccination was not reported. The age group was selected as adult as per vaccine indication. The patient received 2 months ago the first dose of Shingirx and had fever, pain, chilis, swelling, fatigue and vomiting. The reporter did not provided patient's identifiers, no lot number nor expiration date provided, no vaccination date provided no date when the adverse events appeared and recovered provided. The reporter consented to follow up. This case has been linked with the case US2021010469 reported by same reporter.; Sender's Comments:  US-GLAXOSMITHKLINE-US2021010469:same reporter
Sex: U
Vaccine: VARZOS
Symptoms: Vomiting
Clinical narrative: fatigue; swelling; vomiting; pain; chilis; fever; This case was reported by a physician and described the occurrence of fatigue 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 2 months after receiving Shingrix, the patient experienced fatigue, swelling, vomiting, pain, chills and fever. On an unknown date, the outcome of the fatigue, swelling, vomiting, pain, chills and fever were recovered/resolved.   It was unknown if the reporter considered the fatigue, swelling, vomiting, pain, chills and fever to be related to Shingrix.  Additional details were provided as follows: The age at vaccination was not reported. The age group was selected as adult as per vaccine indication. The patient received 2 months ago the first dose of Shingirx and had fever, pain, chilis, swelling, fatigue and vomiting. The reporter did not provided patient's identifiers, no lot number nor expiration date provided, no vaccination date provided no date when the adverse events appeared and recovered provided. The reporter consented to follow up. This case has been linked with the case US2021010469 reported by same reporter.; Sender's Comments:  US-GLAXOSMITHKLINE-US2021010469:same reporter
Sex: U
Vaccine: VARZOS
Symptoms: Pyrexia
Clinical narrative: fever; This case was reported by a physician and described the occurrence of fever 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 2 months after receiving Shingrix, the patient experienced fever. On an unknown date, the outcome of the fever was recovered/resolved.   It was unknown if the reporter considered the fever to be related to Shingrix.  Additional details were provided as follows: The age at vaccination was not reported. The age group was selected as adult as per vaccine indication. The patient received 1st dose of Shingrix and experienced fever. The reporter consented to follow up. The case was linked with the case US2021010470, reported by same reporter.; Sender's Comments:  US-GLAXOSMITHKLINE-US2021010470:same reporter
Sex: M
Vaccine: VARZOS
Symptoms: Diarrhoea, Influenza like illness
Clinical narrative: diarrhea; flu like symptoms; This case was reported by a consumer via call center representative and described the occurrence of diarrhea in a male patient who received Herpes zoster (Shingrix) for prophylaxis.   On an unknown date, the patient received Shingrix. On an unknown date, 1 day after receiving Shingrix, the patient experienced diarrhea and influenza-like symptoms. On an unknown date, the outcome of the diarrhea and influenza-like symptoms were recovered/resolved.   It was unknown if the reporter considered the diarrhea and influenza-like symptoms to be related to Shingrix.  Additional details were provided as follows: The patient was reporter's pharmacist. The age at vaccination was not reported. The patient had to cancel a fishing trip because the day after getting Shingrix, he had diarrhea and flu like symptoms that lasted 3 days. The reporter did not consent to follow-up. The reporter thought that the pharmacist would welcome a call and gave his number for follow-up.; Sender's Comments:  US-GLAXOSMITHKLINE-US2021010485:same reporter
Age: 65.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site erythema, Injection site pruritus, Injection site vesicles
Clinical narrative: half dollar size redness around injection site; itching; blisters at site of injection; This case was reported by a pharmacist and described the occurrence of injection site erythema in a 65-year-old female patient who received Herpes zoster (Shingrix) (batch number 744AH, expiry date 3rd October 2022) for prophylaxis.   On 8th January 2021, the patient received the 1st dose of Shingrix. On an unknown date, less than 2 weeks after receiving Shingrix, the patient experienced injection site erythema, injection site itching and injection site blisters. On an unknown date, the outcome of the injection site erythema, injection site itching and injection site blisters were unknown.   It was unknown if the reporter considered the injection site erythema, injection site itching and injection site blisters to be related to Shingrix.  Additional details were reported as follows: The age at vaccination was not reported. The patient had Shingrix had redness around injection site which has increased in size to half-dollar size, the area was itching and has blisters. Did not consent to follow-up.
Sex: F
Vaccine: VARZOS
Symptoms: Injection site erythema, Injection site pain, Injection site pruritus, Injection site warmth, Urticaria
Clinical narrative: hives / itchy; hot in the injection site; pain /  in the injection site; redness / in the injection site; Injection site itchy; This case was reported by a pharmacist via call center representative and described the occurrence of hives in a female patient who received Herpes zoster (Shingrix) for prophylaxis.   On 4th January 2021, the patient received Shingrix. On 4th January 2021, several hours after receiving Shingrix, the patient experienced hives, injection site warmth, injection site pain, injection site erythema and injection site itching. On an unknown date, the outcome of the hives was not recovered/not resolved and the outcome of the injection site warmth, injection site pain, injection site erythema and injection site itching were unknown.   It was unknown if the reporter considered the hives, injection site warmth, injection site pain, injection site erythema and injection site itching to be related to Shingrix.  Additional details were provided as follows: Age at vaccination was not reported. The Shingrix was administrated to the patient and some hours after the vaccination the patient had redness, itchy, pain, hot in the injection site and hives. At the time of reporting, the patient still had hive in her chest. The reporter consented to follow up. This case was linked with the case US2021015571 reported by same reporter.; Sender's Comments:  US-GLAXOSMITHKLINE-US2021015571:same reporter
Sex: F
Vaccine: VARZOS
Symptoms: Injection site discolouration, Injection site erythema, No adverse event
Clinical narrative: Experienced redness at the injection site, that turned purple; Experienced redness at the injection site, that turned purple; This case was reported by a consumer via call center representative and described the occurrence of injection site erythema in a 65-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included Shingrix with an associated reaction of no adverse event (1st dose received on an unknown date).   On an unknown date, the patient received the 2nd dose of Shingrix (intramuscular). On an unknown date, unknown after receiving Shingrix, the patient experienced injection site erythema and injection site discoloration. On an unknown date, the outcome of the injection site erythema and injection site discoloration were recovered/resolved.   It was unknown if the reporter considered the injection site erythema and injection site discoloration to be related to Shingrix.  Additional details were provided as follows: The patient had reported the case for herself. The age at vaccination was not reported, however it could be 62 or 63 years. The patient received 2nd dose sometime in 2018 specific date unknown and experienced redness at the injection site, that turned purple. The reporter did not consent to follow-up.
Sex: F
Vaccine: VARZOS
Symptoms: Erythema, Injection site erythema
Clinical narrative: redness / inch and a half below the injections site.; This case was reported by a consumer via call center representative and described the occurrence of erythema in a female patient who received Herpes zoster (Shingrix) for prophylaxis.   On 24th January 2021, the patient received the 2nd dose of Shingrix. In January 2021, less than a week after receiving Shingrix, the patient experienced erythema. On an unknown date, the outcome of the erythema was unknown.   It was unknown if the reporter considered the erythema to be related to Shingrix.  Additional details were provided as follows: The age at vaccination was not reported. Patient received the dose of Shingrix and presented redness an inch and a half below the injections site and redness was presented in a 3 inches radius. Patient refused to answer any additional questions. The reporter did not consent to follow up
Sex: F
Vaccine: VARZOS
Symptoms: Pain in extremity
Clinical narrative: had a sore arm; This case was reported by a consumer via call center representative and described the occurrence of pain in arm in a female patient who received Herpes zoster (Shingrix) for prophylaxis.   In October 2020, the patient received the 1st dose of Shingrix (intramuscular) .5 ml. On an unknown date, less than 3 months after receiving Shingrix, the patient experienced pain in arm. On an unknown date, the outcome of the pain in arm was recovered/resolved.   It was unknown if the reporter considered the pain in arm to be related to Shingrix.  Additional details were reported as follows: The patient received Shingrix at the end of October and had a sore arm that resolved quickly.   No lot number or expiration date for either vaccine was known. The reporter consented to follow up. For tolerances of 2nd dose, refer case US2021AMR022113, reported by same reporter for the same patient.; Sender's Comments:  US-GLAXOSMITHKLINE-US2021AMR022113:same reporter
Age: 58.0
Sex: F
Vaccine: VARZOS
Symptoms: Herpes zoster
Clinical narrative: Dose 1 / on October 27, 2020 / Patient is experiencing a shingles outbreak; This case was reported by a pharmacist via call center representative and described the occurrence of shingles in a 58-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   On 27th October 2020, the patient received the 1st dose of Shingrix (intramuscular). On 26th January 2021, 91 days after receiving Shingrix, the patient experienced shingles. On an unknown date, the outcome of the shingles was not recovered/not resolved.   It was unknown if the reporter considered the shingles to be related to Shingrix.  Additional details were provided as follows: The patient received Shingrix and experiencing a shingles outbreak.  The patient had not yet received the second dose. The reporter did not consent to follow up.
Sex: F
Vaccine: VARZOS
Symptoms: Dyspnoea, Headache, Injected limb mobility decreased, Injection site pain, Pain
Clinical narrative: injection site pain; Headache / severe headache; Difficulty Breathing; Pain / body aches /; could not use her right arm; This case was reported by a consumer via call center representative and described the occurrence of injection site pain in a 67-year-old female 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 a day after receiving Shingrix, the patient experienced injection site pain, headache, difficulty breathing, pain and injected limb mobility decreased. Shingrix was interrupted. On an unknown date, the outcome of the injection site pain was unknown and the outcome of the headache, difficulty breathing, pain and injected limb mobility decreased were recovered/resolved.   It was unknown if the reporter considered the injection site pain, headache, difficulty breathing, pain and injected limb mobility decreased to be related to Shingrix.  Additional information were provided as follows: The age at vaccination was not reported. The patient received 1st dose of shingrix and she developed pain, difficulty breathing, body aches throughout,a severe headache,injection site pain and injected limb mobility decreased. The reporter stated that  the headache did not resolve for more than a week, and she could not use her right arm for 3 days, with the soreness lasting more than 3 weeks,and her difficulty breathing resolved the night she received the vaccination.  The reporter informed that  her HCP advised her not to get the second dose. The reporter consented to follow up.
Sex: M
Vaccine: VARZOS
Symptoms: Headache, Injection site pain
Clinical narrative: injection site pain; headache, head pain; This case was reported by a consumer via call center representative and described the occurrence of injection site pain in a male patient who received Herpes zoster (Shingrix) for prophylaxis.   On 4th February 2021, the patient received the 2nd dose of Shingrix. In February 2021, less than a week after receiving Shingrix, the patient experienced injection site pain and headache. In February 2021, the outcome of the injection site pain and headache were recovered/resolved.   It was unknown if the reporter considered the injection site pain and headache to be related to Shingrix.  Additional details were reported as follows: The age at vaccination was not reported. The patient had a headache, head pain, and injection site pain. The headache and injection site pain resolved 4 days later. The patient did not want to provide any additional details for adverse event or give Health Care Professional  information. The reporter did not consented to follow up.
Sex: F
Vaccine: COVID19
Symptoms: Injection site erythema, Limb discomfort, Pain in extremity, Paraesthesia, Paraesthesia oral
Clinical narrative: tingling in arms; tingling in lips; pain that went down her whole arm; arm feels painful and she can't move it; has been hurting all day; red ring around injection site; A spontaneous report from was received from a Reporter  concerning a unknown year old female patient who received Moderna's COVID-19 vaccine (mRNA-1273) and experienced events    like Paraesthesia, Oral Paraesthesia, Limb discomfort, injection site erythema.  The patient's medical history was not provided. No relevant concomitant medications were reported.        On unknown date, after receiving the dose of Moderna COVID vaccine (mRNA-1273) (lot/batch: unknown) intramuscularly in the arm for prophylaxis of COVID-19 infection.      On date or an unknown date, The patient experienced tingling in the arms, tingling in lips, pain that went down her whole arm, arm hurting, red ring around her injection site, and painful arm which can't be moved. Treatment included diphenhydramine hydrochloride and two steroids for her symptoms, which subsided.         Action taken with mRNA-1273 in response to the events was reported.       On date 5 January 2021 the outcome of the events like pain in extremity, limb discomfort, injection site erythema are unkown.; Reporter's Comments: This case concerns a female of unknown age who had serious unexpected events of tingling of extremity, oral paraesthesia, and pain in extremity, NS unexpected arm discomfort, and NS expected injection site erythema. Event onset 15 minutes after first dose of mRNA-1273. Treated with Benadryl and steroids. Events subsided. Based on current available information and temporal association between use of the product and the start date of the event, a causal relationship cannot be excluded.
Age: 53.0
Sex: F
Vaccine: COVID19
Symptoms: Abdominal pain upper, Arthralgia, Back pain, Body temperature, Chest discomfort
Clinical narrative: Lymph nodes swelled up; Couldn't breathe; Diarrhea; Stomach hurt; Profusely sweat; Arm was sore; Fatigue; Chills; Fever; Headache; Teeth chattering; Joints hurt; Coughing; Chest tightness; Back hurt; Got so sick; A spontaneous report (United States) was received from a consumer, a 53-year-old, female patient who received Moderna's COVID-19 vaccine (mRNA-1273), and who experienced lymph nodes swelled up (lymphadenopathy), couldn't breathe (dyspnoea), chest tightness (chest discomfort), got so sick (illness), arm was sore (pain in extremity), headache, fever (pyrexia), chills, fatigue, teeth chattering (chills), coughing (cough), joints hurt (arthralgia), profusely sweat (hyperhidrosis), back hurt (back pain), diarrhea (diarrhoea), and stomach hurt (stomach pain).   The patient's medical history was not reported. Concomitant product use was not provided by the reporter.   On 16 Jan 2021, prior to the onset of the symptoms, the patient received their first of two planned doses of mRNA-1273 (Batch number: 027L20A) intramuscularly in the left arm for prophylaxis of COVID-19 infection.    Around 6:30 pm on the same day, the patient's arm was sore. She also started getting a headache, fever up to 103 Fahrenheit (F), and chills. She got "so sick, she couldn't breathe", so she used her continuous positive airway pressure machine (CPAP), but it didn't help. She felt fatigued and was coughing. Her joints hurt that night until the next day. Her teeth were chattering until the next day. She had a fever and started to profusely sweat for a couple of hours. She had chest tightness and her back hurt.  On 17 Jan 2021, her temperature was 95 F.  On 18 Jan 2021, the patient's stomach hurt and stopped later that day. The she had diarrhea.  On 19 Jan 2021, she reported that she still had a temperature of 95 F, coughing, fatigue, arm soreness, diarrhea, chest tightness, and back pain.  On 20 Jan 2021, the patient's lymph nodes swelled up and she was having difficulty breathing. She went to an urgent care and from there she was "sent/admitted" to the hospital. No treatment information was provided.  The events, teeth chattering and arthralgia, profusely sweat, were considered resolved on 17 Jan 2021. The event, stomach hurt, resolved on 18 Jan 2021. The events, chest tightness, arm was sore, fever, fatigue, coughing, diarrhea, back hurt, were considered not resolved. The events, lymph nodes swelled up, couldn't breathe, headache, chills, got so sick, were considered unknown.; Reporter's Comments: This case concerns a 53-year-old female with serious unexpected lymphadenopathy and dyspnea and NS unexpected cough, chest tightness, arm pain, back pain, stomach pain, sickness, diarrhea, hyperhidrosis and NS expected headache, fatigue, fever, chills, teeth chattering, arthralgia. Event onset the same day as first dose mRNA-1273. Based on current available information and temporal association between use of the product and the start date of the event, a causal relationship cannot be excluded.