chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 60.0
Sex: F
Vaccine: COVID19
Symptoms: Ocular discomfort, Vision blurred
Clinical narrative: Received the vaccine shot in the morning of March 24th, as the day wore on the vision in my right eye changed, becoming cloudy and somewhat obscured, it felt like i had some pressure or the right eyeball was swollen a bit,  I had difficulty focusing  close up, difficulty reading. When looking at distant objects, such as a street light, the light source looked like a spiky ring of light.  The vision in the left eye was a bit cloudy but that was gone by the morning of the 25th.  The vision issues in the right eye continued through most of the 25th though the feeling of pressure diminished and the  vision issues also lessened.  The eye/vision is still not completely back to normal on the 26th but is much better.
Age: 55.0
Sex: F
Vaccine: COVID19
Symptoms: Chills, Headache, Myalgia, Nausea, Pain
Clinical narrative: Severe debilitating headache, severe muscle pain , severe almost paralyzing body aches , chills for about 36 hours , slight nausea
Age: 25.0
Sex: F
Vaccine: COVID19
Symptoms: Contusion
Clinical narrative: Bruises
Age: 49.0
Sex: F
Vaccine: COVID19
Symptoms: Herpes zoster
Clinical narrative: Diagnosed with Shingles 3/23/2021
Age: 25.0
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, Computerised tomogram, Fatigue, Pain, Pyrexia
Clinical narrative: Fever, body aches, tired after 2nd dose of Covid vaccine on 2/10/21. EE received both Covid Vaccines Moderna, first dose 1/3/21, second dose 2/10/21. Patient tested Covid positive on 3/23/21  and 3/25/21.
Age: 25.0
Sex: F
Vaccine: COVID19
Symptoms: SARS-CoV-2 test positive
Clinical narrative: Fever, body aches, tired after 2nd dose of Covid vaccine on 2/10/21. EE received both Covid Vaccines Moderna, first dose 1/3/21, second dose 2/10/21. Patient tested Covid positive on 3/23/21  and 3/25/21.
Age: 15.0
Sex: F
Vaccine: COVID19
Symptoms: Product administered to patient of inappropriate age
Clinical narrative: She lied about her age when registering for the vaccine. She was given the vaccine at 15 years old. This was not discovered until after she received the vaccine.
Age: 57.0
Sex: M
Vaccine: COVID19
Symptoms: Dyspnoea, Swelling
Clinical narrative: Approximately 5 mins after receiving the vaccine, c/o difficulty breathing & neck begun to swell.  Epinephrine administered, O2 administered. After approximately 10 mins further epinephrine administered and Decadron IM. Transferred via EMS to hospital.
Age: 69.0
Sex: F
Vaccine: COVID19
Symptoms: Headache, Pain
Clinical narrative: Headache, body aches, wanted to sleep. Ok the next day
Age: 52.0
Sex: F
Vaccine: COVID19
Symptoms: Anaphylactic reaction, Rash, Rash erythematous, Rash papular
Clinical narrative: Raised red rash on chest and anaphylactic symptoms
Age: 41.0
Sex: F
Vaccine: COVID19
Symptoms: Axillary pain, Breast pain, Headache, Pain, Pain in extremity
Clinical narrative: Sore arm - started 2 hours after dose Headache - started 4 hours after dose Pain and swelling in left armpit - started 26 hours after dose and continues; shooting pain down to fingertips, into left breast and down left side of torso.
Age: 62.0
Sex: F
Vaccine: COVID19
Symptoms: Hypoaesthesia oral, Pruritus, Swollen tongue, Throat irritation
Clinical narrative: Pt experienced lip numbness and tongue "thickness" between 5 and 10 minutes post-vaccine administration. She was brought to Observation are, vital signs checked and symptoms monitored. 1 dose antihistamine given at 1205pm. She then felt itchiness in throat and ears. 2nd dose po antihistamine given with complete relief of sx's at 1235pm.
Age: 64.0
Sex: F
Vaccine: COVID19
Symptoms: Confusional state
Clinical narrative: Possible adverse event. Temporary and quick onset confusion, couldn't find way home from walk.
Age: 64.0
Sex: M
Vaccine: UNK
Symptoms: Body temperature increased, Chills, Pain, Pyrexia
Clinical narrative: Had a low-grade fever (99.6 to 100.2), chills, and body aches.  These lasted less than 24 hours.  I took ibuprofen.
Age: 30.0
Sex: F
Vaccine: COVID19
Symptoms: Dizziness, Dyspnoea, Migraine, Nausea, Pyrexia
Clinical narrative: Unable to sleep due to level of fever, shaking, nausea and dizziness. Fever, SOB, and dizziness continued until around 10:30 am the next day. Caused a migraine.
Age: 30.0
Sex: F
Vaccine: COVID19
Symptoms: Sleep disorder, Tremor
Clinical narrative: Unable to sleep due to level of fever, shaking, nausea and dizziness. Fever, SOB, and dizziness continued until around 10:30 am the next day. Caused a migraine.
Age: 82.0
Sex: U
Vaccine: COVID19
Symptoms: Extra dose administered
Clinical narrative: Patient came to public clinic with neighbor to receive COVID vaccine. Dr. medically screened the patient, she asked if she was able to answer her own screening questions to which the caregiver neighbor stated ?absolutely? the patient was oriented and stated name, date of birth and address and answered all screening questions.  They received Moderna 006b21a by  NP in their right arm and then a family member showed up at the door stating ?she?s already had it? . Patient had received Pfizer COVID vaccine on 2/3/2021 and 2/24/2021.  Family member states she had a mild reaction after her series, with injection site pain and abdominal discomfort. Patient was monitored for 30 mins without reaction. PCP has been notified and HCP  is aware as well. She has visiting nursing 4 times a day at home and I will follow up with HCP this afternoon for re-eval.  Board of health physician Dr.  notified. Patient and family members present have been counseled on adverse reactions and when to seek medical care. Information will be reviewed with HCP today as well.
Age: 32.0
Sex: F
Vaccine: COVID19
Symptoms: Headache, Injection site erythema, Injection site pain, Injection site swelling, Nodule
Clinical narrative: 3/24/21 3:00pm: I got the vaccine 9:00pm:  99.1 fever which increased to 99.4.  10:00pm: went to bed  3/25/21 2:00 am:  talking and moaning in my sleep talking gibberish in my sleep. Woke up 101.8 fever took tylenol 7:00 am-6:00pm: swollen red circle on left arm, body aches, headache, fever 101.6-101.8. Took Tylenol. Every 6 hours. 6:00 pm: noticed a tiny pea size lump above my left collar bone.  9:00pm- bump grew to the size of a gum ball and very tender. Left arm injection site grew more red, tender, and swollen. 3/26/21 7:00am 99.1 fever and lump grew slightly larger over left collar bone. Left arm still very red, swollen and tender. Approx 2.5 inch diameter circle around injection site.
Age: 32.0
Sex: F
Vaccine: COVID19
Symptoms: Pain, Pyrexia, Sleep talking
Clinical narrative: 3/24/21 3:00pm: I got the vaccine 9:00pm:  99.1 fever which increased to 99.4.  10:00pm: went to bed  3/25/21 2:00 am:  talking and moaning in my sleep talking gibberish in my sleep. Woke up 101.8 fever took tylenol 7:00 am-6:00pm: swollen red circle on left arm, body aches, headache, fever 101.6-101.8. Took Tylenol. Every 6 hours. 6:00 pm: noticed a tiny pea size lump above my left collar bone.  9:00pm- bump grew to the size of a gum ball and very tender. Left arm injection site grew more red, tender, and swollen. 3/26/21 7:00am 99.1 fever and lump grew slightly larger over left collar bone. Left arm still very red, swollen and tender. Approx 2.5 inch diameter circle around injection site.
Age: 54.0
Sex: M
Vaccine: COVID19
Symptoms: Dizziness
Clinical narrative: Client verbalized feeling faint and light headed.  Client was evaluated by Fire Rescue.  Client was released to go home at 5:15 pm.  Per Fire Rescue no further evaluation needed.
Age: 26.0
Sex: M
Vaccine: COVID19
Symptoms: Injection site erythema, Injection site rash, Insomnia, Pruritus
Clinical narrative: ?Covid arm?  Red bumps appeared around spot where vaccine was injected approx 48 hours after dose 1. Itchy. Also had tough time sleeping which is rare for me. Maybe related.
Age: 52.0
Sex: M
Vaccine: COVID19
Symptoms: Rash erythematous, Rash papular, Rash pruritic, Urticaria
Clinical narrative: developed red raised itchy rash on both arms as well as torso, described as an urticarial rash
Age: 53.0
Sex: F
Vaccine: COVID19
Symptoms: Feeling abnormal, Palpitations, Rash
Clinical narrative: Pt developed a rash behind her ears, on the back of her neck, and on her upper back about 15 minutes post vaccination. She reported feeling funny and like her heart was racing. Her pulse rate was 120. Her blood pressure was 180/100.
Age: 41.0
Sex: M
Vaccine: COVID19
Symptoms: Chills, Fatigue, Headache, Hyperhidrosis
Clinical narrative: Had Fatigue, chills, & dull headache @ 7:30pm.  Went to bed early.  Woke up @ 4:20 am for work and had fatigue, headache, and sweats on forehead.  Took 2 Ibuprofen and went back to bed.  woke up at 9:15 am and still had slight fatigue & headache.  Effects seemed manageable, so didn?t go  see a doctor.  It?s about 11am & I still have a dull headache,.
Age: 44.0
Sex: F
Vaccine: COVID19
Symptoms: Erythema, Increased upper airway secretion, Pruritus
Clinical narrative: Patient developed itchiness redness systemic  with "phlem" feeling  in throat patient  sent to the ED
Age: 65.0
Sex: M
Vaccine: COVID19
Symptoms: Chills, Injection site pain, Pain, Poor quality sleep, Pyrexia
Clinical narrative: 1st shot, sore at injection site, no problem.  2nd shot, felt feverish that evening. Sore at injection site. Toss and turn all night. 100.8* fever, aches, pains, chills. No other symptoms yet the morning after 2nd shot.
Age: 63.0
Sex: F
Vaccine: COVID19
Symptoms: CSF white blood cell count, Magnetic resonance imaging spinal abnormal, Muscular weakness, Paraesthesia
Clinical narrative: On 3-22 11 days after vaccination), patient presented with lower extremity weakness and uper extremity paresthesias
Age: 74.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Chills, Confusional state, Decreased appetite, Fatigue, Pruritus
Clinical narrative: Confusion, fevers and chills for 72 hours. After 6 weeks. Extreme fatigue , both  soles of feet itching  for 4-5 days , goes away , has come back. Usually in th evenings and  and early mornings. Appetite low, have lost several pounds.
Age: 74.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Pyrexia, Weight decreased
Clinical narrative: Confusion, fevers and chills for 72 hours. After 6 weeks. Extreme fatigue , both  soles of feet itching  for 4-5 days , goes away , has come back. Usually in th evenings and  and early mornings. Appetite low, have lost several pounds.
Age: 72.0
Sex: M
Vaccine: COVID19
Symptoms: Coagulation test, Mesenteric vein thrombosis
Clinical narrative: Superior mesenteric vein thrombosis.  No known cause at this time.  Hypercoag panel negative.  patient hospitalized and currently on Xarelto for 6 months. Received vaccination dose 2 1 week prior.
Age: 32.0
Sex: M
Vaccine: COVID19
Symptoms: Ageusia, Anosmia, COVID-19, Headache, Rhinorrhoea
Clinical narrative: on 3/20/2021 patient developed rhinorrhea, headache, and loss of taste/smell.  Tested positive for COVID after vaccination.
Age: 32.0
Sex: M
Vaccine: COVID19
Symptoms: SARS-CoV-2 test positive
Clinical narrative: on 3/20/2021 patient developed rhinorrhea, headache, and loss of taste/smell.  Tested positive for COVID after vaccination.
Age: 78.0
Sex: F
Vaccine: COVID19
Symptoms: Asthenia, Dizziness
Clinical narrative: Pt received vaccine and waited 30 minutes post-vaccination due to list of allergies/intolerances to medications/vaccines. After leaving vaccine clinic, Pt developed weakness and dizziness and returned to COVID Vaccination Clinic to report symptoms.  Vitals signs taken: 238/101 HR 87BPM, O2 97%; Emergency Responders called to transport Pt to ER for evaluation; BP 217/100 on recheck.
Age: 25.0
Sex: F
Vaccine: COVID19
Symptoms: Menstruation delayed
Clinical narrative: Period came 4 days later than usual
Age: 59.0
Sex: F
Vaccine: COVID19
Symptoms: Oral pruritus, Pruritus
Clinical narrative: Patient had reported itchiness and rash over their whole body after dose 1. Her doctor was informed and she was instructed to use Benadryl as needed for treatment of symptoms during her second dose.  After her second dose given on 3/26/21, while monitoring for a reaction, patient informed us of onset of itchiness on arms and in mouth., no visible rash.   I administered 50mg dose of diphenhydramine and monitored further 30 minutes.
Age: 1.33
Sex: M
Vaccine: DTAPIPVHIB, PNC13
Symptoms: Rash
Clinical narrative: pt had vaccines on 3/18 and on 3/22 developed rash on body, arms and legs and buttox, spares abdomen and back and face. mom putting hydrocortisone on area with some relief. rash improved at visit on 3/24, but still with some present. treated with antihistamine and exam done. called mom 3/26/21 to check on child, voicemail left. no swelling of lips, tongue or joints. no fever. acting well and eating well. sleeping well.
Age: 59.0
Sex: F
Vaccine: COVID19
Symptoms: Blister, Erythema, Pain of skin, Rash, Skin swelling
Clinical narrative: rash started on face then 2 days later appeared on stomach.  by day 4 stomach was puffy, red, and hurt, by day 8 blisters began to form and it continued to spread on stomach.  By day 8 face rash had disappeared
Age: 41.0
Sex: F
Vaccine: COVID19
Symptoms: Injection site erythema, Injection site pruritus, Injection site swelling, Injection site warmth, Pruritus
Clinical narrative: 8 days after injection redness, swelling, and itching at injection site.  Arm is hot to touch where red.  Itching on other parts of body.  Have treated with ice.
Age: 11.0
Sex: M
Vaccine: HPV9
Symptoms: No adverse event, Product storage error
Clinical narrative: No other AE reported; temperature excursion 11 C for 10 hrs, vaccine administered; This spontaneous report was received from a medical assistant and refers to a 11-year-old male Hispanic patient. There was no information about the patient's concurrent conditions, concomitant therapies or medical history provided. On 02-MAR-2021 (also reported as yesterday), the patient was vaccinated with improperly stored 0.5 ml dose of hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast) (GARDASIL 9) lot # T007035, expiration date 01-MAY-2022 (the route of administration was not reported) for prophylaxis. There was no adverse effect reported. Administered dose of vaccine experienced the temperature excursion of 11 degrees Celsius for 10 hours. Data logger was involved. There were no previous excursions reported.  On 09-MAR-2021, an inbound phone call was received from a medical assistant (MA) who works with nurse practitioner (NP, correspondence contact). The MA was calling in response to the Merck correspondence received in the mail regarding the patient who had received hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast) (GARDASIL 9) vaccinations after the vaccine had undergone a temperature excursion on 16-FEB-2021 for 10 hours. The lot number and expiration date were previously reported. The adverse event follow-up process was reviewed with both the MA and the NP and they verbalized understanding. The MA stated that she was the health care professional (HCP) who administered the vaccines to the four patients listed below. The MA states that she was certified and trained to administer these vaccines. The MA provided patient's age, gender and ethnic group. The MA stated that she would hold onto each letter in case there was additional information to report. Minimal information was obtained on that day, due to the HCPs being "very busy". At the time of the phone call, the patient had not experienced cellulitis, erythema, or swelling at the site of the injection. The vaccine was not available for return.  Additional information is not expected.  This is one of several reports received from the same reporter. combinationproductreport: Yes; brandname: GARDASIL 9 SYRINGE (DEVICE); commondevicename: HPV rL1 6 11 16 18 31 33 45 52 58 VLP vaccine (yeast); productcode: FMF; devicetype: SYRINGE, PISTON (FMF); manufacturername: Merck Sharp & Dohme Corp.; devicelotnumber: T007035; expirationdate: 01-MAY-2022; deviceage and unit: 0 ; operatorofdevice: Health Care Professional; malfunction: Unknown; productavailableforevaluation: No; deviceusage: Initial; reasonfornoneval: 81 Other; labeledsingleusedevice: No; mdcpreportability: No; mdcpreprationale: Case information does not meet the criteria for Reportability; Sender's Comments:  US-009507513-2103USA001467: US-009507513-2103USA001532: US-009507513-2103USA001535:
Age: 15.0
Sex: F
Vaccine: HPV9
Symptoms: No adverse event, Product storage error
Clinical narrative: No other AE reported; temperature excursion (11 C for 10 hrs), vaccine administered; This spontaneous report was received from a medical assistant and refers to a 15-year-old female patient. There was no information about the patient's concurrent conditions, concomitant therapies or medical history provided. On 02-MAR-2021 (also reported as yesterday), the patient was vaccinated with improperly stored 0.5 ml dose of hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast) (GARDASIL 9) lot # T007035, expiration date 01-MAY-2022 (the route of administration was not reported) for prophylaxis. There was no adverse effect reported. Administered dose of vaccine experienced the temperature excursion of 11 degrees Celsius for 10 hours. Data logger was involved. There were no previous excursions reported.  On 09-MAR-2021, an inbound phone call was received from a medical assistant (MA) who works with nurse practitioner (NP, correspondence contact). The MA was calling in response to the Merck correspondence received in the mail regarding the patient who had received hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast) (GARDASIL 9) vaccinations after the vaccine had undergone a temperature excursion on 16-FEB-2021 for 10 hours. The lot number and expiration date were previously reported. The adverse event follow-up process was reviewed with both the MA and the NP and they verbalized understanding. The MA stated that she was the health care professional (HCP) who administered the vaccines to the four patients listed below. The MA states that she was certified and trained to administer these vaccines. The MA provided patient's age, gender and ethnic group. The MA stated that she would hold onto each letter in case there was additional information to report. Minimal information was obtained on that day, due to the HCPs being "very busy". At the time of the phone call, the patient had not experienced cellulitis, erythema, or swelling at the site of the injection. The vaccine was not available for return. Additional information is not expected.  This is one of several reports received from the same reporter. combinationproductreport: Yes; brandname: GARDASIL 9 SYRINGE (DEVICE); commondevicename: HPV rL1 6 11 16 18 31 33 45 52 58 VLP vaccine (yeast); productcode: FMF; devicetype: SYRINGE, PISTON (FMF); manufacturername: Merck Sharp & Dohme Corp. ; devicelotnumber: T007035; expirationdate: 01-MAY-2021; deviceage and unit: 0 ; malfunction: Unknown; productavailableforevaluation: No; deviceusage: Initial; reasonfornoneval: 81 Other; labeledsingleusedevice: No; mdcpreportability: No; mdcpreprationale: Case information does not meet the criteria for Reportability; Sender's Comments:  US-009507513-2103USA001467: US-009507513-2103USA001526: US-009507513-2103USA001535:
Sex: F
Vaccine: VARCEL
Symptoms: Unevaluable event
Clinical narrative: Rash around their waste; This spontaneous report as received from a medical assistant refers to a currently 29 years old female patient. Patient's concurrent conditions, medical history and concomitant therapies were not provided.  On an unknown date, when the patient was a child, she was vaccinated with a first dose of varicella virus vaccine live (oka/merck)(VARIVAX) (dose, route, lot # and expiration date were not provided) for prophylaxis.   At that time, the patient developed a rash around their waste and recovered from it on an unspecified date. The reporter would like to know if it would be a contraindication in getting the vaccine as an adult, as the patient is 29 years old now and needed a varicella virus vaccine live (oka/merck)(VARIVAX) booster. The reporter inquired if there is a possibility of getting the rash again. No product quality complaint (PQC) reported.
Sex: F
Vaccine: HPV4
Symptoms: Systemic lupus erythematosus
Clinical narrative: My daughter got lupus after the Gardasil vaccine.; This spontaneous report was received from an other healthcare professional and a patient's mother via Pfizer and refers to a female patient of an unknown age. No information regarding the patient's medical history, concurrent conditions or concomitant medications was provided.  On an unknown date, the patient was vaccinated with Quadrivalent Human Papillomavirus (Types 6,11,16,18) Recomb. Vaccine (GARDASIL) (lot #, expiration date, dose, route and site of administration were not reported) for prophylaxis.  On an unspecified date, after the vaccination, she got lupus. The outcome of the event was not reported.  The causality between the event of lupus and the suspect vaccine was not provided.  Upon internal review, the event of lupus was determined to be medically significant.
Sex: U
Vaccine: FLUX
Symptoms: Dyspnoea, Wheezing
Clinical narrative: wheezing; sob; This case was reported by a pharmacist via other manufacturer and described the occurrence of wheezing in a 39-year-old patient who received Flu Seasonal QIV Dresden (Influenza vaccine Quadrivalent unspecified season) for prophylaxis.   On an unknown date, the patient received Influenza vaccine Quadrivalent unspecified season. On an unknown date, unknown after receiving Influenza vaccine Quadrivalent unspecified season, the patient experienced wheezing and shortness of breath. On an unknown date, the outcome of the wheezing and shortness of breath were unknown.   It was unknown if the reporter considered the wheezing and shortness of breath to be related to Influenza vaccine Quadrivalent unspecified season.  Additional details were provided as follows: The age at vaccination was not reported. The patient experienced shortness of breath and wheezing after vaccination with flu. This case has been linked with the case US2021AMR012841 reported by same reporter.; Sender's Comments:  US-GLAXOSMITHKLINE-US2021AMR012841:same patient
Sex: U
Vaccine: VARZOS
Symptoms: Incomplete course of vaccination, Nerve injury, Pain in extremity
Clinical narrative: still have pain / in that arm from my shoulder all the way down to my middle finger; nerve damage in that arm from my shoulder all the way down to my middle finger; This case was reported by a consumer via interactive digital media 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 the 1st dose of Shingrix. On an unknown date, unknown after receiving Shingrix, the patient experienced pain in arm and nerve damage. Shingrix was discontinued. On an unknown date, the outcome of the pain in arm and nerve damage were not recovered/not resolved.   It was unknown if the reporter considered the pain in arm and nerve damage 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's reaction was so severe, his/her Doctor advised not to get the second Shingrix shot.  The patient still had pain and nerve damage in that arm from his/her shoulder all the way down to his/her middle finger.
Sex: F
Vaccine: VARZOS
Symptoms: Blister, Ophthalmic herpes zoster, Photophobia, Vaccination failure
Clinical narrative: suspected vaccination failure/got that in her eye; got that in her eye; blisters; couldn't stand light in my eye slept under covers; This case was reported by a consumer via interactive digital media and described the occurrence of vaccination failure in a female patient who received Herpes zoster (Shingles vaccine).   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), blister and photophobia. On an unknown date, the outcome of the vaccination failure, ophthalmic herpes zoster, blister and photophobia were unknown.   It was unknown if the reporter considered the vaccination failure, ophthalmic herpes zoster, blister and photophobia to be related to Shingles vaccine.  Additional details were provided as follows: The case was reported by patient's friend. The age at vaccination was not reported. The patient got shingles in her eye after vaccination. The had blisters and patient could not stand in light This case was considered as suspected vaccination failure as time to onset, number of doses and laboratory confirmation test were unknown at the time of reporting. This was 1 of 3 cases reported by same reporter.; Sender's Comments:  US-GLAXOSMITHKLINE-US2021AMR062659:same reporter US-GLAXOSMITHKLINE-US2021AMR069212:same reporter US-GLAXOSMITHKLINE-US2021AMR062659:same reporter
Sex: U
Vaccine: VARZOS
Symptoms: Micturition disorder
Clinical narrative: Urinary problems; This case was reported by a consumer via interactive digital media and described the occurrence of micturition disorder 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 micturition disorder. On an unknown date, the outcome of the micturition disorder was unknown.   It was unknown if the reporter considered the micturition disorder 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 selected as adult as per vaccine indication. The patient experienced urinary problems.
Sex: F
Vaccine: VARZOS
Symptoms: Blister, Erythema, Malaise, Pain, Pyrexia
Clinical narrative: Chickenpox-like blisters on face; Chickenpox-like blisters / related to casuality of chicken pox like blisters with HZ vaccine; Redness / around the blisters; Pain around the blisters; Also experienced fever; Also experienced / malaise; This case was reported by a pharmacist via call center representative and described the occurrence of blister in a female patient who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included Shingrix (1st dose received on an unknown date).   On an unknown date, the patient received the 2nd dose of Shingrix. On an unknown date, 2 weeks after receiving Shingrix, the patient experienced blister, varicella-like rash, localized erythema, pain localized, fever and malaise. On an unknown date, the outcome of the blister, varicella-like rash, localized erythema and pain localized were unknown and the outcome of the fever and malaise were recovered/resolved.   It was unknown if the reporter considered the blister, fever and malaise to be related to Shingrix. The reporter considered the varicella-like rash, localized erythema and pain localized to be possibly related to Shingrix.  Additional details were provided as follows: The age at vaccination was not reported. The patient received 2nd dose of Shingrix and experienced chickenpox like blisters on face 2 weeks post dose, which were thought to be related to herpes zoster by the reporter. The patient experienced redness and pain around the blisters 2 weeks post the dose. The patient also experienced fever and malaise the day after her second dose, both events lasted 1 day. No further information reported.
Sex: F
Vaccine: VARZOS
Symptoms: Rash vesicular
Clinical narrative: Chickenpox-like blisters on face; Chickenpox-like blisters / related to casuality of chicken pox like blisters with HZ vaccine; Redness / around the blisters; Pain around the blisters; Also experienced fever; Also experienced / malaise; This case was reported by a pharmacist via call center representative and described the occurrence of blister in a female patient who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included Shingrix (1st dose received on an unknown date).   On an unknown date, the patient received the 2nd dose of Shingrix. On an unknown date, 2 weeks after receiving Shingrix, the patient experienced blister, varicella-like rash, localized erythema, pain localized, fever and malaise. On an unknown date, the outcome of the blister, varicella-like rash, localized erythema and pain localized were unknown and the outcome of the fever and malaise were recovered/resolved.   It was unknown if the reporter considered the blister, fever and malaise to be related to Shingrix. The reporter considered the varicella-like rash, localized erythema and pain localized to be possibly related to Shingrix.  Additional details were provided as follows: The age at vaccination was not reported. The patient received 2nd dose of Shingrix and experienced chickenpox like blisters on face 2 weeks post dose, which were thought to be related to herpes zoster by the reporter. The patient experienced redness and pain around the blisters 2 weeks post the dose. The patient also experienced fever and malaise the day after her second dose, both events lasted 1 day. No further information reported.
Age: 68.0
Sex: M
Vaccine: VARZOS
Symptoms: General symptom, Herpes zoster
Clinical narrative: This case was reported by a consumer via call center representative and described the occurrence of shingles in a 68-year-old male patient who received Herpes zoster SHINGRIX for prophylaxis. On 9th March 2021, the patient received the 1st dose of SHINGRIX. On 16th March 2021, 7 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 had reported the case for himself. The patient received vaccine in his left arm at his doctor's office. The patient did not know lot or expiration date of SHINGRIX vaccine. The patient reported with concern that he contracted shingles after receiving SHINGRIX vaccine. The patient stated that he developed a full case of shingles and his symptoms had not resolve as of the reporting time. The patient gave consent to follow up with his health care professional. The reporter did not wish to have SHINGRIX emailed to him, nor did he wish to have the company telephone number to give to his health care professional. The reporter was transferred to patient assistance for questions regarding SHINGRIX financial questions. The consent to follow-up was granted.
Sex: F
Vaccine: VARZOS, VARZOS
Symptoms: Peripheral swelling, Pruritus, Rash, Rash pruritic
Clinical narrative: Several bumps that itched in her head and scalp; arm swelling; never received the second dose of Shingrix but she couldn't be certain; This case was reported by a consumer via call center representative and described the occurrence of itchy rash in a 57-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   Co-suspect products included Herpes zoster (Shingrix) for prophylaxis.   Concurrent medical conditions included drug-drug pharmacodynamic interaction.   On an unknown date, the patient received the 1st dose of Shingrix and the 2nd dose of Shingrix. On an unknown date, 12 hrs after receiving Shingrix and not applicable after receiving Shingrix, the patient experienced itchy rash, swelling arm and incomplete course of vaccination. On an unknown date, the outcome of the itchy rash was recovered/resolved and the outcome of the swelling arm and incomplete course of vaccination were unknown.   It was unknown if the reporter considered the itchy rash and swelling arm to be related to Shingrix.  Additional details were provided as follows: The case was reported by patient's Mother. The age at vaccination was not reported. The patient received the 1st dose of Shingrix several years ago and experienced several bumps that itched in her head and scalp itched and also had arm swelling. The reporter believed that the reactions started within 12 hours of receiving the 1st dose and she was uncertain when the side effects resolved. The reporter explained that the patient recently had a similar reaction to the Pfizer COVID vaccine so she was curious if her daughter could be allergic to an ingredient in both vaccines. The reporter believed that her daughter never received the 2nd dose of Shingrix but she could not be certain which led to incomplete course of vaccination. The reporter consented to follow up.
Age: 64.0
Sex: F
Vaccine: VARZOS
Symptoms: Arthralgia, Headache, Hypoaesthesia, Injected limb mobility decreased, Injection site pain
Clinical narrative: hand gets / numb; shooting pains radiate from injection site, from the muscle / through the neck; shooting pains radiate from injection site, from the muscle / to the left side of my head; cannot move shoulder back at all. Cannot bend shoulder backward and has limited mobility.; severe pain at arm of injection, left arm, deltoid / Pain radiates to the scapula and forehand / Cannot sleep on that arm; shooting pains radiate from injection site, from the muscle, up the shoulder/The trigeminal radiation of pain at times; Worst pain at the injection site; severe tendonitis; muscle pains; hand gets cold; This case was reported by a physician and described the occurrence of injection site pain in a 64-year-old female patient who received Herpes zoster (Shingrix) (batch number N42DE, expiry date 4th June 2022) for prophylaxis.   On 12th September 2020, the patient received the 1st dose of Shingrix. On 13th September 2020, 1 days after receiving Shingrix, the patient experienced injection site pain, tendonitis, muscle pain, cold hands, joint range of motion decreased, pain in arm and shoulder pain. On an unknown date, the patient experienced numbness in hand, neck pain and headache. On an unknown date, the outcome of the injection site pain, numbness in hand, shoulder pain, neck pain and headache were unknown and the outcome of the tendonitis, muscle pain, cold hands, joint range of motion decreased and pain in arm were not recovered/not resolved.   It was unknown if the reporter considered the injection site pain, tendonitis, muscle pain, cold hands, numbness in hand, joint range of motion decreased, pain in arm, shoulder pain, neck pain and headache to be related to Shingrix.  Additional details were provided as follows: This case was reported by patient herself. The patient received 1st dose of Shingrix in left arm deltoid and experiencing severe pain at arm of injection. The patient had been experiencing severe tendonitis and muscle pains and they were not easing up.  The pain radiates to the scapula and forehand. Worst pain at the injection site. Sometimes the patient hand gets cold and numb and could not move shoulder back at all.  The patient cannot bend shoulder backward and had limited mobility.  The patient could not sleep on that arm and sometimes shooting pains radiate from injection site, from the muscle, up the shoulder and through the neck and sometimes to the left side of head. The trigeminal radiation of pain at times, sometimes very disabling like shoulder was going to be ripped apart. The reporter consented to follow up.  The email could not be obtained since reporter mentioned that had many emails and did not remember passwords, maybe would contact a family member. For tolerances of 2nd dose, refer case US2021AMR070411.; Sender's Comments:  US-GLAXOSMITHKLINE-US2021AMR070411:same reporter
Age: 64.0
Sex: F
Vaccine: VARZOS
Symptoms: Joint range of motion decreased, Myalgia, Neck pain, Pain, Pain in extremity
Clinical narrative: hand gets / numb; shooting pains radiate from injection site, from the muscle / through the neck; shooting pains radiate from injection site, from the muscle / to the left side of my head; cannot move shoulder back at all. Cannot bend shoulder backward and has limited mobility.; severe pain at arm of injection, left arm, deltoid / Pain radiates to the scapula and forehand / Cannot sleep on that arm; shooting pains radiate from injection site, from the muscle, up the shoulder/The trigeminal radiation of pain at times; Worst pain at the injection site; severe tendonitis; muscle pains; hand gets cold; This case was reported by a physician and described the occurrence of injection site pain in a 64-year-old female patient who received Herpes zoster (Shingrix) (batch number N42DE, expiry date 4th June 2022) for prophylaxis.   On 12th September 2020, the patient received the 1st dose of Shingrix. On 13th September 2020, 1 days after receiving Shingrix, the patient experienced injection site pain, tendonitis, muscle pain, cold hands, joint range of motion decreased, pain in arm and shoulder pain. On an unknown date, the patient experienced numbness in hand, neck pain and headache. On an unknown date, the outcome of the injection site pain, numbness in hand, shoulder pain, neck pain and headache were unknown and the outcome of the tendonitis, muscle pain, cold hands, joint range of motion decreased and pain in arm were not recovered/not resolved.   It was unknown if the reporter considered the injection site pain, tendonitis, muscle pain, cold hands, numbness in hand, joint range of motion decreased, pain in arm, shoulder pain, neck pain and headache to be related to Shingrix.  Additional details were provided as follows: This case was reported by patient herself. The patient received 1st dose of Shingrix in left arm deltoid and experiencing severe pain at arm of injection. The patient had been experiencing severe tendonitis and muscle pains and they were not easing up.  The pain radiates to the scapula and forehand. Worst pain at the injection site. Sometimes the patient hand gets cold and numb and could not move shoulder back at all.  The patient cannot bend shoulder backward and had limited mobility.  The patient could not sleep on that arm and sometimes shooting pains radiate from injection site, from the muscle, up the shoulder and through the neck and sometimes to the left side of head. The trigeminal radiation of pain at times, sometimes very disabling like shoulder was going to be ripped apart. The reporter consented to follow up.  The email could not be obtained since reporter mentioned that had many emails and did not remember passwords, maybe would contact a family member. For tolerances of 2nd dose, refer case US2021AMR070411.; Sender's Comments:  US-GLAXOSMITHKLINE-US2021AMR070411:same reporter
Age: 64.0
Sex: F
Vaccine: VARZOS
Symptoms: Peripheral coldness, Sleep disorder, Tendonitis
Clinical narrative: hand gets / numb; shooting pains radiate from injection site, from the muscle / through the neck; shooting pains radiate from injection site, from the muscle / to the left side of my head; cannot move shoulder back at all. Cannot bend shoulder backward and has limited mobility.; severe pain at arm of injection, left arm, deltoid / Pain radiates to the scapula and forehand / Cannot sleep on that arm; shooting pains radiate from injection site, from the muscle, up the shoulder/The trigeminal radiation of pain at times; Worst pain at the injection site; severe tendonitis; muscle pains; hand gets cold; This case was reported by a physician and described the occurrence of injection site pain in a 64-year-old female patient who received Herpes zoster (Shingrix) (batch number N42DE, expiry date 4th June 2022) for prophylaxis.   On 12th September 2020, the patient received the 1st dose of Shingrix. On 13th September 2020, 1 days after receiving Shingrix, the patient experienced injection site pain, tendonitis, muscle pain, cold hands, joint range of motion decreased, pain in arm and shoulder pain. On an unknown date, the patient experienced numbness in hand, neck pain and headache. On an unknown date, the outcome of the injection site pain, numbness in hand, shoulder pain, neck pain and headache were unknown and the outcome of the tendonitis, muscle pain, cold hands, joint range of motion decreased and pain in arm were not recovered/not resolved.   It was unknown if the reporter considered the injection site pain, tendonitis, muscle pain, cold hands, numbness in hand, joint range of motion decreased, pain in arm, shoulder pain, neck pain and headache to be related to Shingrix.  Additional details were provided as follows: This case was reported by patient herself. The patient received 1st dose of Shingrix in left arm deltoid and experiencing severe pain at arm of injection. The patient had been experiencing severe tendonitis and muscle pains and they were not easing up.  The pain radiates to the scapula and forehand. Worst pain at the injection site. Sometimes the patient hand gets cold and numb and could not move shoulder back at all.  The patient cannot bend shoulder backward and had limited mobility.  The patient could not sleep on that arm and sometimes shooting pains radiate from injection site, from the muscle, up the shoulder and through the neck and sometimes to the left side of head. The trigeminal radiation of pain at times, sometimes very disabling like shoulder was going to be ripped apart. The reporter consented to follow up.  The email could not be obtained since reporter mentioned that had many emails and did not remember passwords, maybe would contact a family member. For tolerances of 2nd dose, refer case US2021AMR070411.; Sender's Comments:  US-GLAXOSMITHKLINE-US2021AMR070411:same reporter
Age: 67.0
Sex: M
Vaccine: COVID19
Symptoms: Eye abscess
Clinical narrative: Giant red blister burst in right eye; A spontaneous report was received from a consumer concerning a 67-years-old male patient who received Moderna's COVID-19 vaccine (mRNA-1273) and experienced giant red blister burst in right eye.  The patient's medical history was not reported. Concomitant medications of blood pressure medications and thyroid medications.  On 03 Feb 2021, approximately two days prior to the onset of the event, the patient received the first of two planned doses of mRNA-1273 (lot/batch number: unknown) for prophylaxis of COVID-19 infection.  On 04 Feb 2021, the patient experienced medically significant event of giant red blister that burst in right eye overnight. Vision was okay and patient does not feel pain. The patient was going to see ophthalmologist. No treatment information was provided.  Action taken with mRNA-1273 in response to the event was not reported.   The outcome of the event giant red blister burst in right eye was not reported.; Reporter's Comments: Based on the current available information and temporal association between the use of the product and the start date of the event, a causal relationship cannot be excluded.
Age: 48.0
Sex: F
Vaccine: COVID19
Symptoms: Bell's palsy
Clinical narrative: diagnosed with bell's palsy; A spontaneous report was received from a pharmacist concerning a 49-years-old female patient who received Moderna's COVID-19 vaccine (mRNA-1273) and diagnosed with bell's palsy.  The patient's medical history was not provided. No relevant concomitant medications were reported.  On 14 Jan 2021, prior to the onset of the events the patient received their first of two planned doses of mRNA-1273 (lot batch: 013L20A) intramuscularly for prophylaxis of COVID-19 infection.  On 16 Jan 2021, two days after receiving the vaccination the patient diagnosed with bell's palsy. The event was considered to be medically significant.  No treatment information was provided.  Action taken with mRNA-1273 in response to the events was not reported.   At the time of reporting, the outcome of event was not reported.; Reporter's Comments: Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded. Further information has been requested
Sex: F
Vaccine: COVID19
Symptoms: Chest discomfort, Dizziness, Dyspnoea, Injection site erythema, Injection site reaction
Clinical narrative: passed out about 7 to 8 times; Pain on the right side of body; Dizziness; Felt like golf ball in right chest; Couldn't breathe; Nausea; Fever; Injection site redness; Outer part of the skin is bumpy; A spontaneous report  was received from a consumer, a 46-year-old female patient, who was administered Moderna's COVID-19 vaccine (mRNA-1273) and experienced passed out about 7 to 8 times/loss of consciousness, pain on the right side of body/pain, dizziness, felt like golf ball in right chest/chest discomfort, couldn't breathe/dyspnea, nausea, fever/pyrexia, injection site redness/injection site erythema and outer part of the skin is bumpy/injection site reaction.  The patient's medical history included was migraine. Product known to have been used by the patient, within two weeks prior to the event, included was ibuprofen for migraine.  On 12 Jan 2021, the patient received their first of two planned doses of mRNA-1273 (Lot number: 011J20A) intramuscularly in her left arm for prophylaxis of COVID-19 infection.  On 12 Jan 2021, the patient experienced feeling a lot of pain on the right side of her body and the shot was given on her left arm. Fever, nauseous, supper dizzy, passed out about 7 to 8 times, felt like she got a golf ball in her right chest, red on the injection site, the outer part of the skin is all bumpy, couldn't breathe. Treatment for the events included were ibuprofen and diclofenac injection.  The Action taken with the second dose of mRNA-1273 in response to the event was not reported.   The outcome of the events, passed out about 7 to 8 times/loss of consciousness, pain on the right side of body/pain, dizziness, felt like golf ball in right chest/chest discomfort, couldn't breathe/dyspnea, nausea, fever/pyrexia, injection site redness/injection site erythema and outer part of the skin is bumpy/injection site reaction were considered as unknown.; Reporter's Comments: Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded. Further information has been requested.
Sex: F
Vaccine: COVID19
Symptoms: Loss of consciousness, Nausea, Pain, Pyrexia
Clinical narrative: passed out about 7 to 8 times; Pain on the right side of body; Dizziness; Felt like golf ball in right chest; Couldn't breathe; Nausea; Fever; Injection site redness; Outer part of the skin is bumpy; A spontaneous report  was received from a consumer, a 46-year-old female patient, who was administered Moderna's COVID-19 vaccine (mRNA-1273) and experienced passed out about 7 to 8 times/loss of consciousness, pain on the right side of body/pain, dizziness, felt like golf ball in right chest/chest discomfort, couldn't breathe/dyspnea, nausea, fever/pyrexia, injection site redness/injection site erythema and outer part of the skin is bumpy/injection site reaction.  The patient's medical history included was migraine. Product known to have been used by the patient, within two weeks prior to the event, included was ibuprofen for migraine.  On 12 Jan 2021, the patient received their first of two planned doses of mRNA-1273 (Lot number: 011J20A) intramuscularly in her left arm for prophylaxis of COVID-19 infection.  On 12 Jan 2021, the patient experienced feeling a lot of pain on the right side of her body and the shot was given on her left arm. Fever, nauseous, supper dizzy, passed out about 7 to 8 times, felt like she got a golf ball in her right chest, red on the injection site, the outer part of the skin is all bumpy, couldn't breathe. Treatment for the events included were ibuprofen and diclofenac injection.  The Action taken with the second dose of mRNA-1273 in response to the event was not reported.   The outcome of the events, passed out about 7 to 8 times/loss of consciousness, pain on the right side of body/pain, dizziness, felt like golf ball in right chest/chest discomfort, couldn't breathe/dyspnea, nausea, fever/pyrexia, injection site redness/injection site erythema and outer part of the skin is bumpy/injection site reaction were considered as unknown.; Reporter's Comments: Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded. Further information has been requested.