chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 0.67
Sex: F
Vaccine: DTAPIPVHIB, PNC, RV5
Symptoms: Seizure
Clinical narrative: seizure; This spontaneous report was received from a consumer, a father calling on behalf of the daughter: an 8-month-old female patient. Information regarding the patient's concurrent conditions, medical history, historical drugs and concomitant therapies was not provided.  On 10-MAR-2021, the patient was vaccinated with the third dose in the three-dose series of rotavirus vaccine, live, oral, pentavalent (ROTATEQ) lot # 1661010, expiration date not reported but upon internal validation established as 29-MAY-2021, oral for prophylaxis (strength, dose, vaccination scheme frequency were not reported), along with pneumococcal 4 6b 9v 14 18c 19f 23f conj vaccine (crm197) (PREVNAR) and hib conj vaccine (tet toxoid), diphtheria toxoid, pertussis acellular 5-component vaccine, poliovirus vaccine inactivated (mrc-5), tetanus toxoid (PENTACEL) (formulation, strength, dose, frequency, route of administration, indication, lot number and expiration date were not reported).      On the morning of 11-MAR-2021, the patient was hospitalized due to seizures. The patient received the anti-seizure medications acetaminophen (TEMPRA) and phenobarbital. The father reported that there was no reaction to the first two doses of rotavirus vaccine, live, oral, pentavalent (ROTATEQ), and the daughter had no known allergies. The lot numbers for the first and second doses were 1691132 (expiration date not reported but upon internal validation established as 30-NOV-2021) and 1687009 (expiration date not reported but upon internal validation established as 28-JUN-2021) respectively. The outcome of the seizures was reported as recovered.  The reporter considered the seizures to be related to rotavirus Vaccine, Live, Oral, Pentavalent (ROTATEQ). The causal relationship between the seizures and pneumococcal 4 6b 9v 14 18c 19f 23f conj vaccine (crm197) (PREVNAR) and hib conj vaccine (tet toxoid), diphtheria toxoid, pertussis acellular 5-component vaccine, poliovirus vaccine inactivated (mrc-5), tetanus toxoid (PENTACEL) was not reported.   Upon internal review, the seizures were determined to be medically significant.
Sex: F
Vaccine: HPV9, HPV9
Symptoms: Inappropriate schedule of product administration
Clinical narrative: No additional AE reported; Patient received first dose of GARDASIL 9 in 2015, second dose 18FEB2021 and will be getting a third dose soon; This spontaneous report was received from a registered nurse referring to a female patient of unknown age. The patient's pertinent concurrent conditions, medical history, concomitant medications and previous drug reactions or allergies were not provided.   On an unspecified date in 2015, the patient was vaccinated with first dose of hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast) (GARDASIL 9) as prophylaxis (concentration, dosage, route of administration, anatomical location, lot number and expiration date were not reported), then on 18-FEB-2021, the patient was vaccinated with the second dose of hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast) (GARDASIL 9) as prophylaxis (concentration, dosage, route of administration and anatomical location were not reported; lot number 1687290 and expiration date 06-SEP-2022) and the reporter stated that the patient will be getting a third dose soon (inappropriate schedule of product administration). No adverse event was 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: 1687290; expirationdate: 06-SEP-2022; deviceage and unit: 0 ; malfunction: Unknown; deviceusage: Initial; evaluatedbymfr: Not returned to manufacturer; reasonfornoneval: 81 Other; labeledsingleusedevice: No; mdcpreportability: No; mdcpreprationale: Case information does not meet the criteria for Reportability
Sex: U
Vaccine: MMR
Symptoms: No adverse event, Product storage error
Clinical narrative: no adverse event; Incorrect product storage; This spontaneous report was received from a pharmacist refers to about 5 patients of unknown age and gender. The patient´s concurrent conditions, medical history, historical drugs and concomitant therapies were not reported.     Since 11-MAY-2021, the patients were vaccinated with improperly stored doses of measles, mumps, and rubella (wistar ra 27-3) virus vaccine, live(M-M-R II) 0.5 ml, lot # T006166, expiration date 19-FEB-2022 for prophylaxis (route was not reported). The vaccines were exposed to light. No adverse event was reported.
Sex: U
Vaccine: HPV9
Symptoms: Expired product administered, No adverse event
Clinical narrative: no adverse event; a patient was administerd GARDASIL expired on 27-APR-2021; This spontaneous report was received from a registered nurse referring to a patient of unknown age and gender. No information was provided regarding the patient's medical history, concurrent conditions, past drug history or concomitant medications.     On 12-MAY-2021, the patient was vaccinated with hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast) (GARDASIL 9) pre-filled syringe, lot # R027946, 0.5 milliliter for prophylaxis, which had expired on 27-APR-2021 (expired product administered) (dose, route and site of administration were not reported).  There was no adverse effect reported. No product quality complaint was involved.  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: R027946; expirationdate: 27-APR-2021; deviceage and unit: 0 ; malfunction: Unknown; deviceusage: Initial; reasonfornoneval: 81 Other; labeledsingleusedevice: No; mdcpreportability: No; mdcpreprationale: Case information does not meet the criteria for Reportability
Sex: U
Vaccine: COVID19
Symptoms: Atrial fibrillation, Dyspnoea, Pulmonary oedema
Clinical narrative: AFib; large buildup of fluid in my lungs; difficulty breathing; This is a spontaneous report from a contactable consumer (patient). A patient of unspecified age and gender received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE), dose 2 via an unspecified route of administration on an unspecified date (Batch/Lot number was not reported) as 2nd dose, single for COVID-19 immunization. The patient medical history was not reported. Concomitant medications included ongoing apixaban (ELIQUIS) and ongoing metoprolol, both for unspecified indication and from unknown date. Within 6 weeks after receiving the 2nd Pfizer C19 shot, the patient suddenly developed AFib. He/She had never had heart problems and all of a sudden the patient had difficulty breathing. Doctor prescribed large doses of Furosemide because of large buildup of fluid in his/her lungs. The patient was still on ELIQUIS, twice a day and 50 mg of metoprolol twice a day. The patient asked, "Have there been other patients develop AFib after receiving 2nd shot of Pfizer C19". Therapeutic measures were taken as a result of large buildup of fluid in his/her lungs, which included large doses of Furosemide. The outcome of events was unknown.  Additional information received on 30Apr2021 from a contactable consumer, based on information received by Pfizer from Bristol-Myers Squibb (manufacturer control number: US-BRISTOL-MYERS SQUIBB COMPANY-BMS-2021-043584), license party for apixaban (ELIQUIS) included assessment from Bristol-Myers Squibb.  Bristol-Myers Squibb assessed events Afib and Lung edema were not related to apixaban (ELIQUIS). BMS Medical Evaluation Comment: This patient who received apixaban therapy and COVID-19 vaccine had atrial fibrillation and pulmonary edema. Based on the limited information, it cannot be ascertained with reasonable possibility that suspect therapy contributed to the reported events.
Sex: F
Vaccine: VARZOS
Symptoms: Herpes zoster, Vaccination failure
Clinical narrative: shingles vaccine. Shortly after she got the shot broke out with a bad case of shingles / Suspected vaccination failure; bad case of shingles; This case was reported by a consumer via media and described the occurrence of suspected vaccination failure in a female patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   On an unknown date, the patient received Shingles vaccine. On an unknown date, unknown after receiving Shingles vaccine, the patient experienced vaccination failure (serious criteria GSK medically significant) and shingles. On an unknown date, the outcome of the vaccination failure and shingles were unknown.   It was unknown if the reporter considered the vaccination failure and shingles to be related to Shingles vaccine.  Additional details were reported as follows: The patient was reporter's sister-in-law. The age at vaccination was not reported. Shortly after the patient got the shingles shot, she broke out with a bad case of shingles. This case was considered as suspected vaccination failure as details regarding completion of primary vaccination schedule, time to onset and laboratory test confirming herpes zoster were unknown at the time of reporting. The follow-up would not possible as no contact details were available.
Sex: U
Vaccine: VARZOS, VARZOS
Symptoms: Herpes zoster, Vaccination failure
Clinical narrative: I got one shot/ I got both of those/came down with Shingles yesterday / suspected vaccination failure; came down with Shingles yesterday; This case was reported by a consumer via media and described the occurrence of suspected vaccination failure in a adult patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   Co-suspect products included Herpes zoster (Shingles vaccine) for prophylaxis.   Previously administered products included Shingles vaccine (received one dose (possible non gsk vaccine) on an unknown date).   On an unknown date, the patient received the 1st dose of Shingles vaccine and the 2nd dose of Shingles vaccine. On 7th May 2021, several years after receiving Shingles vaccine and Shingles vaccine, the patient experienced vaccination failure (serious criteria GSK medically significant) and shingles. On an unknown date, the outcome of the vaccination failure and shingles were unknown.   It was unknown if the reporter considered the vaccination failure and shingles to be related to Shingles vaccine and Shingles vaccine.  Additional details were reported as follows: This case was reported by patient himself/herself. The age group was not reported but was selected as an adult as per vaccine indication. The age at vaccination was not reported. A couple of years ago, the patient received both doses of new shingles vaccine and a day before reporting, the patient had shingles. The patient stated that he/she had no rash yet, but never had pain. This case was considered as suspected vaccination failure as detail regarding laboratory test confirming herpes zoster was unknown at the time of reporting. The follow-up would not possible as no contact details were available.
Sex: U
Vaccine: VARZOS
Symptoms: Chills, Myalgia, Pain
Clinical narrative: shivering; still very achy; muscle aches; This case was reported by a consumer and described the occurrence of shivering in a adult patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   Previously administered products included Shingles vaccine (1st dose received on an unknown date).   In May 2021, the patient received the 2nd dose of Shingles vaccine. In May 2021, less than a week after receiving Shingles vaccine, the patient experienced shivering, pain and muscle pain. On an unknown date, the outcome of the shivering, pain and muscle pain were not recovered/not resolved.   It was unknown if the reporter considered the shivering, pain and muscle pain to be related to Shingles vaccine.  Additional details were provided as follows: This case was reported by patient himself/herself. The age group was not reported but was selected as an adult as per vaccine indication. The patient had experienced shivering and muscle aches. It had been 3 days still very achy.
Sex: U
Vaccine: VARZOS
Symptoms: Injection site pain
Clinical narrative: The second shot is very painful; 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 (Shingles vaccine) for prophylaxis.   Previously administered products included Shingles vaccine (1st dose received on an unknown date).   On an unknown date, the patient received the 2nd dose of Shingles vaccine. On an unknown date, unknown after receiving Shingles vaccine, 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 Shingles vaccine.  Additional details were provided as follows: This case was reported by patient for himself/herself. The age at vaccination was not reported. The age group was not reported but was captured as an adult as per vaccine indication. The reporter reported the shot was very painful, but very worth. No further information was provided
Age: 24.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Arthralgia, Fatigue, Feeling cold, Feeling hot, Injection site pain
Clinical narrative: FIRST DAY (mon, 4/26)  10 AM - 12 PM adverse event(s):    ? injection site soreness    ? muscle soreness treatment(s):    ? rest  12 PM - 6 PM adverse event(s):    ? injection site soreness    ? muscle soreness    ? tiredness treatment(s):    ? 2 tylenol extra strength caplets    ? rest  6 PM - 12 AM adverse event(s):    ? injection site soreness    ? muscle soreness    ? tiredness    ? felt warm treatment(s):    ? sleep  SECOND DAY (tue, 4/27)  12 AM - 6 AM adverse event(s):    ? injection site pain    ? muscle pain    ? joint pain    ? tiredness/sluggishness    ? felt cold    ? nasal congestion treatment(s):    ? sleep  6 AM - 12 PM adverse event(s):    ? injection site pain    ? muscle pain    ? joint pain    ? tiredness/sluggishness    ? felt warm    ? nasal congestion    ? slight fever (99.9 ° F) treatment(s):    ? rest    ? vick?s vaporub topical ointment  12 PM - 6 PM adverse event(s):    ? injection site pain    ? muscle pain    ? joint pain    ? tiredness/sluggishness    ? felt warm    ? slight fever treatment(s):    ? rest    ? 2 tylenol extra strength caplets  6 PM - 12 AM adverse event(s):    ? injection site pain    ? muscle pain    ? joint pain    ? tiredness/sluggishness    ? felt warm    ? slight fever treatment(s):    ? sleep  THIRD DAY (wed, 4/28)  12 AM - 6 AM adverse event(s):    ? injection site pain    ? muscle pain    ? joint pain    ? tiredness/sluggishness    ? felt warm    ? slight fever treatment(s):    ? sleep  6 AM - 12 PM adverse event(s):    ? injection site pain    ? muscle pain    ? joint pain    ? tiredness/sluggishness    ? felt warm    ? slight fever treatment(s):    ? rest  12 PM - 6 PM adverse event(s):    ? injection site pain    ? muscle pain    ? joint pain    ? tiredness/sluggishness    ? felt warm    ? slight fever treatment(s):    ? rest    ? 2 tylenol extra strength caplets  6 PM - 12 AM adverse event(s):    ? injection site pain    ? muscle pain    ? joint pain    ? tiredness/sluggishness    ? felt warm    ? slight fever treatment(s):    ? sleep  FOURTH DAY (thu, 4/29)  12 AM - 6 AM adverse event(s):    ? injection site soreness    ? muscle soreness    ? joint soreness    ? tiredness    ? felt warm    ? slight fever    treatment(s):    ? sleep  6 AM - 12 PM adverse event(s):    ? injection site soreness    ? muscle soreness    ? joint soreness    ? tiredness    ? felt warm  treatment(s):    ? rest  12 PM - 6 PM adverse event(s):    ? injection site soreness    ? muscle soreness    ? joint soreness    ? tiredness treatment(s):    ? rest    ? 2 tylenol extra strength caplets  6 PM - 12 AM adverse event(s):    ? injection site soreness    ? muscle soreness    ? joint soreness treatment(s):    ? sleep
Age: 24.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Myalgia, Nasal congestion, Pyrexia, Sluggishness
Clinical narrative: FIRST DAY (mon, 4/26)  10 AM - 12 PM adverse event(s):    ? injection site soreness    ? muscle soreness treatment(s):    ? rest  12 PM - 6 PM adverse event(s):    ? injection site soreness    ? muscle soreness    ? tiredness treatment(s):    ? 2 tylenol extra strength caplets    ? rest  6 PM - 12 AM adverse event(s):    ? injection site soreness    ? muscle soreness    ? tiredness    ? felt warm treatment(s):    ? sleep  SECOND DAY (tue, 4/27)  12 AM - 6 AM adverse event(s):    ? injection site pain    ? muscle pain    ? joint pain    ? tiredness/sluggishness    ? felt cold    ? nasal congestion treatment(s):    ? sleep  6 AM - 12 PM adverse event(s):    ? injection site pain    ? muscle pain    ? joint pain    ? tiredness/sluggishness    ? felt warm    ? nasal congestion    ? slight fever (99.9 ° F) treatment(s):    ? rest    ? vick?s vaporub topical ointment  12 PM - 6 PM adverse event(s):    ? injection site pain    ? muscle pain    ? joint pain    ? tiredness/sluggishness    ? felt warm    ? slight fever treatment(s):    ? rest    ? 2 tylenol extra strength caplets  6 PM - 12 AM adverse event(s):    ? injection site pain    ? muscle pain    ? joint pain    ? tiredness/sluggishness    ? felt warm    ? slight fever treatment(s):    ? sleep  THIRD DAY (wed, 4/28)  12 AM - 6 AM adverse event(s):    ? injection site pain    ? muscle pain    ? joint pain    ? tiredness/sluggishness    ? felt warm    ? slight fever treatment(s):    ? sleep  6 AM - 12 PM adverse event(s):    ? injection site pain    ? muscle pain    ? joint pain    ? tiredness/sluggishness    ? felt warm    ? slight fever treatment(s):    ? rest  12 PM - 6 PM adverse event(s):    ? injection site pain    ? muscle pain    ? joint pain    ? tiredness/sluggishness    ? felt warm    ? slight fever treatment(s):    ? rest    ? 2 tylenol extra strength caplets  6 PM - 12 AM adverse event(s):    ? injection site pain    ? muscle pain    ? joint pain    ? tiredness/sluggishness    ? felt warm    ? slight fever treatment(s):    ? sleep  FOURTH DAY (thu, 4/29)  12 AM - 6 AM adverse event(s):    ? injection site soreness    ? muscle soreness    ? joint soreness    ? tiredness    ? felt warm    ? slight fever    treatment(s):    ? sleep  6 AM - 12 PM adverse event(s):    ? injection site soreness    ? muscle soreness    ? joint soreness    ? tiredness    ? felt warm  treatment(s):    ? rest  12 PM - 6 PM adverse event(s):    ? injection site soreness    ? muscle soreness    ? joint soreness    ? tiredness treatment(s):    ? rest    ? 2 tylenol extra strength caplets  6 PM - 12 AM adverse event(s):    ? injection site soreness    ? muscle soreness    ? joint soreness treatment(s):    ? sleep
Age: 24.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Arthralgia, Body temperature, Fatigue, Feeling cold, Feeling hot
Clinical narrative: FIRST DAY (mon, 4/26)  10 AM - 12 PM adverse event(s):    ? injection site soreness    ? muscle soreness treatment(s):    ? rest  12 PM - 6 PM adverse event(s):    ? injection site soreness    ? muscle soreness    ? tiredness treatment(s):    ? 2 tylenol extra strength caplets    ? rest  6 PM - 12 AM adverse event(s):    ? injection site soreness    ? muscle soreness    ? tiredness    ? felt warm treatment(s):    ? sleep  SECOND DAY (tue, 4/27)  12 AM - 6 AM adverse event(s):    ? injection site pain    ? muscle pain    ? joint pain    ? tiredness/sluggishness    ? felt cold    ? nasal congestion treatment(s):    ? sleep  6 AM - 12 PM adverse event(s):    ? injection site pain    ? muscle pain    ? joint pain    ? tiredness/sluggishness    ? felt warm    ? nasal congestion    ? slight fever (99.9 ° F) treatment(s):    ? rest    ? vick?s vaporub topical ointment  12 PM - 6 PM adverse event(s):    ? injection site pain    ? muscle pain    ? joint pain    ? tiredness/sluggishness    ? felt warm    ? slight fever treatment(s):    ? rest    ? 2 tylenol extra strength caplets  6 PM - 12 AM adverse event(s):    ? injection site pain    ? muscle pain    ? joint pain    ? tiredness/sluggishness    ? felt warm    ? slight fever treatment(s):    ? sleep  THIRD DAY (wed, 4/28)  12 AM - 6 AM adverse event(s):    ? injection site pain    ? muscle pain    ? joint pain    ? tiredness/sluggishness    ? felt warm    ? slight fever treatment(s):    ? sleep  6 AM - 12 PM adverse event(s):    ? injection site pain    ? muscle pain    ? joint pain    ? tiredness/sluggishness    ? felt warm    ? slight fever treatment(s):    ? rest  12 PM - 6 PM adverse event(s):    ? injection site pain    ? muscle pain    ? joint pain    ? tiredness/sluggishness    ? felt warm    ? slight fever treatment(s):    ? rest    ? 2 tylenol extra strength caplets  6 PM - 12 AM adverse event(s):    ? injection site pain    ? muscle pain    ? joint pain    ? tiredness/sluggishness    ? felt warm    ? slight fever treatment(s):    ? sleep  FOURTH DAY (thu, 4/29)  12 AM - 6 AM adverse event(s):    ? injection site soreness    ? muscle soreness    ? joint soreness    ? tiredness    ? felt warm    ? slight fever    treatment(s):    ? sleep  6 AM - 12 PM adverse event(s):    ? injection site soreness    ? muscle soreness    ? joint soreness    ? tiredness    ? felt warm  treatment(s):    ? rest  12 PM - 6 PM adverse event(s):    ? injection site soreness    ? muscle soreness    ? joint soreness    ? tiredness treatment(s):    ? rest    ? 2 tylenol extra strength caplets  6 PM - 12 AM adverse event(s):    ? injection site soreness    ? muscle soreness    ? joint soreness treatment(s):    ? sleep
Age: 24.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Myalgia, Nasal congestion, Pyrexia, Vaccination site pain
Clinical narrative: FIRST DAY (mon, 4/26)  10 AM - 12 PM adverse event(s):    ? injection site soreness    ? muscle soreness treatment(s):    ? rest  12 PM - 6 PM adverse event(s):    ? injection site soreness    ? muscle soreness    ? tiredness treatment(s):    ? 2 tylenol extra strength caplets    ? rest  6 PM - 12 AM adverse event(s):    ? injection site soreness    ? muscle soreness    ? tiredness    ? felt warm treatment(s):    ? sleep  SECOND DAY (tue, 4/27)  12 AM - 6 AM adverse event(s):    ? injection site pain    ? muscle pain    ? joint pain    ? tiredness/sluggishness    ? felt cold    ? nasal congestion treatment(s):    ? sleep  6 AM - 12 PM adverse event(s):    ? injection site pain    ? muscle pain    ? joint pain    ? tiredness/sluggishness    ? felt warm    ? nasal congestion    ? slight fever (99.9 ° F) treatment(s):    ? rest    ? vick?s vaporub topical ointment  12 PM - 6 PM adverse event(s):    ? injection site pain    ? muscle pain    ? joint pain    ? tiredness/sluggishness    ? felt warm    ? slight fever treatment(s):    ? rest    ? 2 tylenol extra strength caplets  6 PM - 12 AM adverse event(s):    ? injection site pain    ? muscle pain    ? joint pain    ? tiredness/sluggishness    ? felt warm    ? slight fever treatment(s):    ? sleep  THIRD DAY (wed, 4/28)  12 AM - 6 AM adverse event(s):    ? injection site pain    ? muscle pain    ? joint pain    ? tiredness/sluggishness    ? felt warm    ? slight fever treatment(s):    ? sleep  6 AM - 12 PM adverse event(s):    ? injection site pain    ? muscle pain    ? joint pain    ? tiredness/sluggishness    ? felt warm    ? slight fever treatment(s):    ? rest  12 PM - 6 PM adverse event(s):    ? injection site pain    ? muscle pain    ? joint pain    ? tiredness/sluggishness    ? felt warm    ? slight fever treatment(s):    ? rest    ? 2 tylenol extra strength caplets  6 PM - 12 AM adverse event(s):    ? injection site pain    ? muscle pain    ? joint pain    ? tiredness/sluggishness    ? felt warm    ? slight fever treatment(s):    ? sleep  FOURTH DAY (thu, 4/29)  12 AM - 6 AM adverse event(s):    ? injection site soreness    ? muscle soreness    ? joint soreness    ? tiredness    ? felt warm    ? slight fever    treatment(s):    ? sleep  6 AM - 12 PM adverse event(s):    ? injection site soreness    ? muscle soreness    ? joint soreness    ? tiredness    ? felt warm  treatment(s):    ? rest  12 PM - 6 PM adverse event(s):    ? injection site soreness    ? muscle soreness    ? joint soreness    ? tiredness treatment(s):    ? rest    ? 2 tylenol extra strength caplets  6 PM - 12 AM adverse event(s):    ? injection site soreness    ? muscle soreness    ? joint soreness treatment(s):    ? sleep
Sex: M
Vaccine: VARZOS
Symptoms: Antinuclear antibody positive, Arthralgia, Back pain, Conjunctival granuloma, Conjunctivitis allergic
Clinical narrative: Sclerouveitis of the left eye/ Uveitis; nodular scleritis; annular elastolytic giant cell granuloma of conjuctiva; Granulomatous dermatitis with elastophagotosys multinucleated/ Elastolytic granuloma; Allergic rhinoconjunctivitis; Allergic rhinitis; Periorbital darkening of the skin; Joint pain; Back pain; positive ANA; ocular inflammation; This case was reported by a consumer and described the occurrence of uveitis in a male patient who received Herpes zoster (Shingrix) for prophylaxis.   Concurrent medical conditions included asthma.   On an unknown date, the patient received Shingrix. On an unknown date, 2 weeks after receiving Shingrix, the patient experienced uveitis (serious criteria GSK medically significant), scleritis (serious criteria GSK medically significant), conjunctival granuloma (serious criteria GSK medically significant), granulomatous dermatitis, allergic rhinoconjunctivitis, allergic rhinitis, dark circles under eyes, joint pain, back pain, antinuclear antibody positive and eye inflammation. On an unknown date, the outcome of the uveitis, scleritis, conjunctival granuloma, granulomatous dermatitis, allergic rhinoconjunctivitis, allergic rhinitis, dark circles under eyes, joint pain, back pain, antinuclear antibody positive and eye inflammation were unknown.   It was unknown if the reporter considered the uveitis, scleritis, conjunctival granuloma, granulomatous dermatitis, allergic rhinoconjunctivitis, allergic rhinitis, dark circles under eyes, joint pain, back pain, antinuclear antibody positive and eye inflammation to be related to Shingrix.  Additional details were provided as follows: The case was reported by the daughter of the patient. The age at vaccination was not reported. The reporter stated that the patient had same problem that she had 2 weeks after the shot. The reporter on her skin (right temple) had granulomatous dermatitis with elastophagotosys multinucleated giant cells and intermixed lymphocytes, annular elastolytic giant cell granuloma of conjunctiva. The reporter was diagnosed with uveitis, sclerouveitis, allergic rhinitis. The reporter also had complaint of dark circles under eyes, ocular inflammation, joint and back pain, there was a nodular scleritis, positive ANA (antinuclear antibody), allergic rhinoconjunctivitis. This is 1 of the 3 link cases, reported by same reporter. Note: The reporter stated that the patient had same problem that she had, however did not exactly mention the events experienced by the patient. Hence all the major diagnosis/events of the reporter was added in this case.; Sender's Comments:  US-GLAXOSMITHKLINE-US2021AMR092345:Reporter's case US-GLAXOSMITHKLINE-US2021AMR102602:same reporter / drug/ US-GLAXOSMITHKLINE-US2021AMR102632:Same reporter
Sex: M
Vaccine: VARZOS
Symptoms: Dark circles under eyes, Eye inflammation, Granulomatous dermatitis, Rhinitis allergic, Scleritis
Clinical narrative: Sclerouveitis of the left eye/ Uveitis; nodular scleritis; annular elastolytic giant cell granuloma of conjuctiva; Granulomatous dermatitis with elastophagotosys multinucleated/ Elastolytic granuloma; Allergic rhinoconjunctivitis; Allergic rhinitis; Periorbital darkening of the skin; Joint pain; Back pain; positive ANA; ocular inflammation; This case was reported by a consumer and described the occurrence of uveitis in a male patient who received Herpes zoster (Shingrix) for prophylaxis.   Concurrent medical conditions included asthma.   On an unknown date, the patient received Shingrix. On an unknown date, 2 weeks after receiving Shingrix, the patient experienced uveitis (serious criteria GSK medically significant), scleritis (serious criteria GSK medically significant), conjunctival granuloma (serious criteria GSK medically significant), granulomatous dermatitis, allergic rhinoconjunctivitis, allergic rhinitis, dark circles under eyes, joint pain, back pain, antinuclear antibody positive and eye inflammation. On an unknown date, the outcome of the uveitis, scleritis, conjunctival granuloma, granulomatous dermatitis, allergic rhinoconjunctivitis, allergic rhinitis, dark circles under eyes, joint pain, back pain, antinuclear antibody positive and eye inflammation were unknown.   It was unknown if the reporter considered the uveitis, scleritis, conjunctival granuloma, granulomatous dermatitis, allergic rhinoconjunctivitis, allergic rhinitis, dark circles under eyes, joint pain, back pain, antinuclear antibody positive and eye inflammation to be related to Shingrix.  Additional details were provided as follows: The case was reported by the daughter of the patient. The age at vaccination was not reported. The reporter stated that the patient had same problem that she had 2 weeks after the shot. The reporter on her skin (right temple) had granulomatous dermatitis with elastophagotosys multinucleated giant cells and intermixed lymphocytes, annular elastolytic giant cell granuloma of conjunctiva. The reporter was diagnosed with uveitis, sclerouveitis, allergic rhinitis. The reporter also had complaint of dark circles under eyes, ocular inflammation, joint and back pain, there was a nodular scleritis, positive ANA (antinuclear antibody), allergic rhinoconjunctivitis. This is 1 of the 3 link cases, reported by same reporter. Note: The reporter stated that the patient had same problem that she had, however did not exactly mention the events experienced by the patient. Hence all the major diagnosis/events of the reporter was added in this case.; Sender's Comments:  US-GLAXOSMITHKLINE-US2021AMR092345:Reporter's case US-GLAXOSMITHKLINE-US2021AMR102602:same reporter / drug/ US-GLAXOSMITHKLINE-US2021AMR102632:Same reporter
Sex: M
Vaccine: VARZOS
Symptoms: Uveitis
Clinical narrative: Sclerouveitis of the left eye/ Uveitis; nodular scleritis; annular elastolytic giant cell granuloma of conjuctiva; Granulomatous dermatitis with elastophagotosys multinucleated/ Elastolytic granuloma; Allergic rhinoconjunctivitis; Allergic rhinitis; Periorbital darkening of the skin; Joint pain; Back pain; positive ANA; ocular inflammation; This case was reported by a consumer and described the occurrence of uveitis in a male patient who received Herpes zoster (Shingrix) for prophylaxis.   Concurrent medical conditions included asthma.   On an unknown date, the patient received Shingrix. On an unknown date, 2 weeks after receiving Shingrix, the patient experienced uveitis (serious criteria GSK medically significant), scleritis (serious criteria GSK medically significant), conjunctival granuloma (serious criteria GSK medically significant), granulomatous dermatitis, allergic rhinoconjunctivitis, allergic rhinitis, dark circles under eyes, joint pain, back pain, antinuclear antibody positive and eye inflammation. On an unknown date, the outcome of the uveitis, scleritis, conjunctival granuloma, granulomatous dermatitis, allergic rhinoconjunctivitis, allergic rhinitis, dark circles under eyes, joint pain, back pain, antinuclear antibody positive and eye inflammation were unknown.   It was unknown if the reporter considered the uveitis, scleritis, conjunctival granuloma, granulomatous dermatitis, allergic rhinoconjunctivitis, allergic rhinitis, dark circles under eyes, joint pain, back pain, antinuclear antibody positive and eye inflammation to be related to Shingrix.  Additional details were provided as follows: The case was reported by the daughter of the patient. The age at vaccination was not reported. The reporter stated that the patient had same problem that she had 2 weeks after the shot. The reporter on her skin (right temple) had granulomatous dermatitis with elastophagotosys multinucleated giant cells and intermixed lymphocytes, annular elastolytic giant cell granuloma of conjunctiva. The reporter was diagnosed with uveitis, sclerouveitis, allergic rhinitis. The reporter also had complaint of dark circles under eyes, ocular inflammation, joint and back pain, there was a nodular scleritis, positive ANA (antinuclear antibody), allergic rhinoconjunctivitis. This is 1 of the 3 link cases, reported by same reporter. Note: The reporter stated that the patient had same problem that she had, however did not exactly mention the events experienced by the patient. Hence all the major diagnosis/events of the reporter was added in this case.; Sender's Comments:  US-GLAXOSMITHKLINE-US2021AMR092345:Reporter's case US-GLAXOSMITHKLINE-US2021AMR102602:same reporter / drug/ US-GLAXOSMITHKLINE-US2021AMR102632:Same reporter
Age: 35.0
Sex: F
Vaccine: COVID19
Symptoms: Abortion spontaneous, Blood test normal, Pregnancy test positive, Ultrasound scan normal, Urine analysis normal
Clinical narrative: Miscarriage occurred. First pregnancy after 6 years of trying.
Age: 48.0
Sex: F
Vaccine: COVID19
Symptoms: Musculoskeletal stiffness, Peripheral swelling
Clinical narrative: May 13: left arm swelling, jagged edges around an approximate 12 cm patch.   May 15: stiffness in back radiating out from muscle on left side of spine up to base of head
Age: 16.0
Sex: M
Vaccine: COVID19
Symptoms: Chest pain, Echocardiogram normal, Troponin I increased
Clinical narrative: Pt developed sharp chest pain, intermittent, positional, severe at times.  Occurred within 24 hours of 2nd vaccine administration.  Seemed to improve with ibuprofen taken.  Found to have significantly elevated troponin I to 1.5, concerning for myopericarditis.  Echocardiogram was normal.  Plan for NSAIDs as needed for pain and follow-up with Cardiology.
Age: 41.0
Sex: F
Vaccine: COVID19
Symptoms: Dysmenorrhoea, Heavy menstrual bleeding, Menstrual discomfort, Menstrual disorder, Menstruation irregular
Clinical narrative: Early and irregular menstrual cycle.  After receiving the 2nd moderna  vaccine my menstrual cycle was almost 2 weeks early, it was also very heavy flow with  lots of blood clots, and was very painful. Every period I have had since receiving the COVID vaccine has been uncomfortable and abnormal for me. Before I had a clockwork period that would start every 28th day, flow was heaviest on day 1 and 2(never more than 3 Menstrual cups full) and then tapered off on day 3 and 4 and no cramps.  My periods( hemorrhaging, clots and cramps) are much longer than 4-5 days per-vaccine, they are now lasting  up to 2 weeks.
Age: 41.0
Sex: F
Vaccine: COVID19
Symptoms: Polymenorrhoea
Clinical narrative: Early and irregular menstrual cycle.  After receiving the 2nd moderna  vaccine my menstrual cycle was almost 2 weeks early, it was also very heavy flow with  lots of blood clots, and was very painful. Every period I have had since receiving the COVID vaccine has been uncomfortable and abnormal for me. Before I had a clockwork period that would start every 28th day, flow was heaviest on day 1 and 2(never more than 3 Menstrual cups full) and then tapered off on day 3 and 4 and no cramps.  My periods( hemorrhaging, clots and cramps) are much longer than 4-5 days per-vaccine, they are now lasting  up to 2 weeks.
Age: 49.0
Sex: F
Vaccine: COVID19
Symptoms: Hypoaesthesia, Injection site pain, Limb discomfort, Muscle spasms
Clinical narrative: Numbness, Heaviness and Spasms on vaccinated arm. Pain in the vaccinated area even after 1month from 1st vaccine. Is this normal? Will this eventually go away, its been over a month now.
Sex: U
Vaccine: VARZOS
Symptoms: Herpes zoster, Vaccination failure
Clinical narrative: i had shingles after having had the shot mild but still/Suspect vaccination failure; i had shingles after having had the shot mild but still; This case was reported by a consumer via media and described the occurrence of suspected vaccination failure 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 vaccination failure (serious criteria GSK medically significant) and shingles. On an unknown date, the outcome of the vaccination failure and shingles were unknown.   It was unknown if the reporter considered the vaccination failure and shingles to be related to Shingles vaccine.  Additional details were reported as follows: The age at vaccination was not reported. The age group was not reported but captured as an adult as per vaccine indication The patient received Shingrix and experienced mild case of shingles. This case was considered to be a suspected vaccination failure case, as the details regarding completion of primary vaccination schedule, laboratory confirmation for shingles and time to onset were unknown.
Age: 42.0
Sex: F
Vaccine: COVID19
Symptoms: Adenocarcinoma, Biopsy, Chest X-ray normal, Computerised tomogram abnormal, Lymph node pain
Clinical narrative: 1 week following second dose of vaccine, left subclavicular lymohnode became swollen and tender. Chest x ray showed no findings. Two months later lymoh node edema persisted and I had a chest/abd/pelvic ultrasound which indicated a 4.5 cm mass in left lung, possible metastasis to the spine, liver, and now shows metastasis to the brain in recent brain MRI.  CT scan findings confirmed by biopsy indicating adenocarcinoma.
Age: 42.0
Sex: F
Vaccine: COVID19
Symptoms: Lymphadenopathy, Lymphoedema, Magnetic resonance imaging head abnormal, Metastasis, Pulmonary mass
Clinical narrative: 1 week following second dose of vaccine, left subclavicular lymohnode became swollen and tender. Chest x ray showed no findings. Two months later lymoh node edema persisted and I had a chest/abd/pelvic ultrasound which indicated a 4.5 cm mass in left lung, possible metastasis to the spine, liver, and now shows metastasis to the brain in recent brain MRI.  CT scan findings confirmed by biopsy indicating adenocarcinoma.
Age: 42.0
Sex: F
Vaccine: COVID19
Symptoms: Ultrasound scan abnormal
Clinical narrative: 1 week following second dose of vaccine, left subclavicular lymohnode became swollen and tender. Chest x ray showed no findings. Two months later lymoh node edema persisted and I had a chest/abd/pelvic ultrasound which indicated a 4.5 cm mass in left lung, possible metastasis to the spine, liver, and now shows metastasis to the brain in recent brain MRI.  CT scan findings confirmed by biopsy indicating adenocarcinoma.
Age: 33.0
Sex: F
Vaccine: COVID19
Symptoms: Asthenia, Dizziness
Clinical narrative: Weakness, dizziness
Age: 41.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Rhabdomyolysis
Clinical narrative: Rhabdomyolysis
Age: 41.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Alanine aminotransferase increased, Aspartate aminotransferase increased, Blood creatine phosphokinase increased, Haemoglobin urine present, Headache
Clinical narrative: Rhabdomyolysis
Age: 41.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Myalgia, Myoglobinuria, Pain, Pyrexia, Red blood cells urine positive
Clinical narrative: Rhabdomyolysis
Age: 41.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Rhabdomyolysis, Urine analysis abnormal
Clinical narrative: Rhabdomyolysis
Age: 41.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Rhabdomyolysis
Clinical narrative: Pt developed fever, headache, muscle/body aches for 1-2 days after vaccination. Fever and headache resolved but muscle aches persisted. Presented to ED 5/14/2021, found to have markedly elevated creatine kinase (130,000) and myoglobinuria consistent with rhabdomyolysis. Pt being admitted to hospital for treatment of rhabdomyolysis and further workup.
Age: 41.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Alanine aminotransferase increased, Aspartate aminotransferase increased, Blood creatine phosphokinase increased, Haemoglobin urine present, Headache
Clinical narrative: Pt developed fever, headache, muscle/body aches for 1-2 days after vaccination. Fever and headache resolved but muscle aches persisted. Presented to ED 5/14/2021, found to have markedly elevated creatine kinase (130,000) and myoglobinuria consistent with rhabdomyolysis. Pt being admitted to hospital for treatment of rhabdomyolysis and further workup.
Age: 41.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Myalgia, Myoglobinuria, Pain, Pyrexia, Red blood cells urine positive
Clinical narrative: Pt developed fever, headache, muscle/body aches for 1-2 days after vaccination. Fever and headache resolved but muscle aches persisted. Presented to ED 5/14/2021, found to have markedly elevated creatine kinase (130,000) and myoglobinuria consistent with rhabdomyolysis. Pt being admitted to hospital for treatment of rhabdomyolysis and further workup.
Age: 41.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Rhabdomyolysis, Urine analysis abnormal
Clinical narrative: Pt developed fever, headache, muscle/body aches for 1-2 days after vaccination. Fever and headache resolved but muscle aches persisted. Presented to ED 5/14/2021, found to have markedly elevated creatine kinase (130,000) and myoglobinuria consistent with rhabdomyolysis. Pt being admitted to hospital for treatment of rhabdomyolysis and further workup.
Age: 5.0
Sex: M
Vaccine: UNK
Symptoms: Rash
Clinical narrative: Rash
Age: 25.0
Sex: M
Vaccine: COVID19
Symptoms: Pruritus, Urticaria
Clinical narrative: dozens of Hives, extremely small, around 100+ on each arm, mildly itchy on neck, upper forearms, and elbows.
Sex: U
Vaccine: VARZOS
Symptoms: Herpes zoster, Vaccination failure
Clinical narrative: Took the vaccine and still got nasty shingles/Suspected vaccination failure; Took the vaccine and still got nasty shingles!; This case was reported by a consumer via media and described the occurrence of suspected vaccination failure 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 vaccination failure (serious criteria GSK medically significant) and shingles. On an unknown date, the outcome of the vaccination failure and shingles were unknown.   It was unknown if the reporter considered the vaccination failure and shingles to be related to Shingles vaccine.  Additional details were provided as follows: The case was reported by the patient. The age at vaccination was not reported. The age group was not reported but was selected as an adult as per vaccine indication. The patient took the vaccine and still got nasty shingles. This case was considered as suspected vaccination failure since details regarding completion of primary vaccination schedule, time to onset and laboratoy test confirming shingles were not provided.
Sex: U
Vaccine: VARZOS
Symptoms: Herpes zoster, Ophthalmic herpes zoster, Pain, Vaccination failure
Clinical narrative: I did get the shot but I got shingles anyway/ Suspected vaccination failure; I did get the shot but I got shingles anyway. I also had them in my eye.; I did get the shot but I got shingles anyway; Very, very painful; This case was reported by a consumer and described the occurrence of suspected vaccination failure 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 vaccination failure (serious criteria GSK medically significant), ophthalmic herpes zoster (serious criteria GSK medically significant), shingles and pain. On an unknown date, the outcome of the vaccination failure, ophthalmic herpes zoster and shingles were unknown and the outcome of the pain was recovered/resolved.   It was unknown if the reporter considered the vaccination failure, ophthalmic herpes zoster, shingles and pain to be related to Shingles vaccine.  Additional details were provided as follows: The patient self reported the case. The age group was not reported but was selected as adult as per vaccine indication. The age at vaccination was not reported. The patient got the shot but got shingles anyway. Also had shingles in eye and were very painful. It took more than 2 months before the pain subsided.  The patient advised anyone to get the shot. This case was considered as suspected vaccination failure as details regarding completion of primary vaccination schedule, time to onset for target disease and laboratory confirmation were unknown at the time of reporting.
Sex: U
Vaccine: VARZOS
Symptoms: Herpes zoster, Vaccination failure
Clinical narrative: suspected vaccination failure; shingles / not as bad; This case was reported by a consumer via media and described the occurrence of suspected vaccination failure 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 vaccination failure (serious criteria GSK medically significant) and shingles. On an unknown date, the outcome of the vaccination failure and shingles were unknown.   It was unknown if the reporter considered the vaccination failure and shingles to be related to Shingles vaccine.  Additional details were provided as follows: This case was reported by the patient.  The age at vaccination was not reported. The age group was not reported but was selected as an adult as per vaccine indication.  The patient received vaccine and still experienced shingles but not as bad. This case was considered as suspected vaccination failure, as details regarding completion of primary vaccination schedule, laboratory test confirmation for shingles and time to event onset were unknown.
Sex: U
Vaccine: VARZOS
Symptoms: Herpes zoster
Clinical narrative: patient developed Shingles after / 1st dose of Shingrix; This case was reported by a other health professional and described the occurrence of shingles 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 shingles. On an unknown date, the outcome of the shingles was unknown.   It was unknown if the reporter considered the shingles to be related to Shingrix.  Additional details were provided as follows:  The age at vaccination was not reported.  The age group was not reported but was captured as adult as per vaccine indication. The reporter (admin) said the patient developed Shingles after receiving 1st dose of Shingrix. The reporter consent to follow up.
Sex: U
Vaccine: VARZOS
Symptoms: Pain in extremity
Clinical narrative: had a sore arm for 3 days; This case was reported by a consumer via interactive digital media and described the occurrence of pain in arm in a 70-year-old patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   On an unknown date, the patient received the 1st dose of Shingles vaccine. On an unknown date, less than 6 months after receiving Shingles vaccine, 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 Shingles vaccine.  Additional details were reported as follows: The case was reported by the patient itself. The age at vaccination was not reported. The patient received 1st dose of Shingles and had a sore arm for 3 days, that was it. The patient was happy that it was a lifetime vaccine and stated no problems at all. The follow up would not possible as no contact details were available. For tolerance of 2nd dose, refer case US2021AMR103067, by same reporter.; Sender's Comments:  US-GLAXOSMITHKLINE-US2021AMR103067:same reporter, same patient, same vaccine, different dose (2nd dose)