chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 89.0
Sex: F
Vaccine: COVID19
Symptoms: Balance disorder, Blood pressure increased, Chest X-ray, Computerised tomogram head, Fall
Clinical narrative: difficulty with balance, lethargy, elevated BP, fell in the floor, on 2/16 could not walk and was poorly responsive had to report to the ER, had two seperate ER visits due to lethargy and unable to walk. on 2/17 patient returned to baseline.
Age: 89.0
Sex: F
Vaccine: COVID19
Symptoms: Full blood count, Gait inability, Lethargy, Metabolic function test, Troponin
Clinical narrative: difficulty with balance, lethargy, elevated BP, fell in the floor, on 2/16 could not walk and was poorly responsive had to report to the ER, had two seperate ER visits due to lethargy and unable to walk. on 2/17 patient returned to baseline.
Age: 89.0
Sex: F
Vaccine: COVID19
Symptoms: Unresponsive to stimuli, Urine analysis
Clinical narrative: difficulty with balance, lethargy, elevated BP, fell in the floor, on 2/16 could not walk and was poorly responsive had to report to the ER, had two seperate ER visits due to lethargy and unable to walk. on 2/17 patient returned to baseline.
Age: 69.0
Sex: F
Vaccine: COVID19
Symptoms: Injection site erythema, Injection site pruritus
Clinical narrative: "Covid Arm"  redness and itching around the injection site (about 3-4 inches diameter)
Age: 72.0
Sex: F
Vaccine: COVID19
Symptoms: Chills, Pain, Pyrexia, SARS-CoV-2 test
Clinical narrative: Chills, fever and achy
Age: 73.0
Sex: F
Vaccine: COVID19
Symptoms: Headache, Pain, Pain of skin, Sleep disorder
Clinical narrative: I had been positive for a COVID 19 test in late November and hardly had any symptoms and when I got the vaccine I has body aches headache my skin hurt I couldn?t sleep.
Age: 68.0
Sex: M
Vaccine: UNK
Symptoms: Dry mouth, Pruritus, Tremor
Clinical narrative: Very bad itching scalp and very dry mouth. shakes.
Age: 24.0
Sex: F
Vaccine: COVID19
Symptoms: Lymphadenopathy, Migraine, Nausea, Pain, Pain in extremity
Clinical narrative: Nausea and throwing up. Migraine. Body aches(sore arm). Fever 102.4 at peak. Swollen lymph node on same side as injection. Swollen arm.
Age: 24.0
Sex: F
Vaccine: COVID19
Symptoms: Peripheral swelling, Pyrexia, Vomiting
Clinical narrative: Nausea and throwing up. Migraine. Body aches(sore arm). Fever 102.4 at peak. Swollen lymph node on same side as injection. Swollen arm.
Age: 77.0
Sex: F
Vaccine: COVID19
Symptoms: Pharyngeal paraesthesia, Pruritus, Sensation of foreign body, Throat irritation, Urticaria
Clinical narrative: Itching/hives bilateral axilla. Sensation of lump in throat/itching tingling in throat. EMS on site. Patient's Epi-pen used left thigh. EMS started IV in left AC gave fluids and gave 25 mg Benadryl IV. Vitals monitored. Symptoms improved shortly after medication administration. Med unit transported patient to hospital for further evaluation.
Age: 42.0
Sex: F
Vaccine: COVID19
Symptoms: Headache, Injection site pain, Injection site rash, Injection site warmth
Clinical narrative: Had a massive headache for 2 days, then a rash for the past 3 days on injection rate that felt hot to touch and soreness.   Rash has slowly gone away.
Age: 52.0
Sex: F
Vaccine: COVID19
Symptoms: Pain in extremity
Clinical narrative: left arm pain and soreness
Age: 85.0
Sex: M
Vaccine: COVID19
Symptoms: Dizziness, Electrocardiogram normal, Hypopnoea, Incoherent, Pallor
Clinical narrative: ound patient in sitting position in elevator s/p 2nd dose of vaccine. Patient awake, opening eyes, mumbling, incoherent speech, noted to be pale. As per patient's wife, "He felt dizzy and used walker to assist himself into a sitting position on elevator floor. He did not hit his head, I do not think he lost consciousness. He waited in the waiting room for more than 15 minutes and drank 2 cups of juice before we left." No obvious injuries noted. Palpated weak, thready pulse. Patient tachypneic w/ shallow respirations. Called for assistance. Vital signs: B/P 98/34, HR 121, RR 23, unappreciated O2 sat. Fingers cool to touch. FS = 139. Attempted to re-orient patient, given small sip of apple juice. 911 activated. Patient transported to ER with wife. Noted patient to be more alert, responsive with clearer speech upon arrival to ER. After monitored in the ER, the patient was cleared for discharge.
Age: 85.0
Sex: M
Vaccine: COVID19
Symptoms: Tachypnoea
Clinical narrative: ound patient in sitting position in elevator s/p 2nd dose of vaccine. Patient awake, opening eyes, mumbling, incoherent speech, noted to be pale. As per patient's wife, "He felt dizzy and used walker to assist himself into a sitting position on elevator floor. He did not hit his head, I do not think he lost consciousness. He waited in the waiting room for more than 15 minutes and drank 2 cups of juice before we left." No obvious injuries noted. Palpated weak, thready pulse. Patient tachypneic w/ shallow respirations. Called for assistance. Vital signs: B/P 98/34, HR 121, RR 23, unappreciated O2 sat. Fingers cool to touch. FS = 139. Attempted to re-orient patient, given small sip of apple juice. 911 activated. Patient transported to ER with wife. Noted patient to be more alert, responsive with clearer speech upon arrival to ER. After monitored in the ER, the patient was cleared for discharge.
Age: 70.0
Sex: F
Vaccine: COVID19
Symptoms: Injection site erythema, Injection site pruritus, Injection site rash, Tenderness
Clinical narrative: Exactly 8 days after first vaccine an approx 3? red circle rash appeared around the injection site.  It didn?t hurt but was tender to the touch and itched non stop.  I took Benadryl by mouth and bought topical Benadryl to help control the itching.  After 1 day after a week the rash was totally gone.
Age: 74.0
Sex: F
Vaccine: COVID19
Symptoms: Injection site erythema, Injection site pruritus, Injection site rash
Clinical narrative: Developed red itchy rash at injection site one week after injection. Started as diffuse area 5x7cm and by the following day area was circumscribed  8x10cm and edematous. No medical visit as research showed this to be a documented side effect in some patients. Used Benadryl oral and OTC cortizone cream topically.
Age: 60.0
Sex: F
Vaccine: COVID19
Symptoms: Feeling abnormal, Hypoaesthesia, Muscle spasms, Pain in extremity, Vaccination site haemorrhage
Clinical narrative: The morning after my vaccine, I drank a half of cup of coffee and started feeling funny, went to the restroom and threw up and than I had this weird feeling kind of like a numbness that went from my arms down to my legs and my hands turned in like they were going to cramp up, I started breathing slowly and it all went away,  I was fine after that. My left arm stayed sore for about 3 days, also when they gave me the shot I bled a little.
Age: 60.0
Sex: F
Vaccine: COVID19
Symptoms: Vomiting
Clinical narrative: The morning after my vaccine, I drank a half of cup of coffee and started feeling funny, went to the restroom and threw up and than I had this weird feeling kind of like a numbness that went from my arms down to my legs and my hands turned in like they were going to cramp up, I started breathing slowly and it all went away,  I was fine after that. My left arm stayed sore for about 3 days, also when they gave me the shot I bled a little.
Age: 23.0
Sex: F
Vaccine: COVID19
Symptoms: Gingival blister, Injection site erythema, Injection site pain, Injection site swelling, Oral mucosal blistering
Clinical narrative: Ever since I received the vaccine, my arm has been extremely sore. Over the next few days, I became incredibly itchy and developed a rash on both of my arms. I now have what I think is considered, "COVID Arm". There is a red circle around the injection site that is swollen, red, and tender. I then noticed the inside of my mouth was sore and I had blisters developing on the roof of my mouth near my gums. My throat is super sore and swollen and has a yellow pocket on the back of my throat. I am also having body aches under my arms near my ribs and back.
Age: 23.0
Sex: F
Vaccine: COVID19
Symptoms: Oral pain, Oropharyngeal pain, Pain, Pain in extremity, Pharyngeal swelling
Clinical narrative: Ever since I received the vaccine, my arm has been extremely sore. Over the next few days, I became incredibly itchy and developed a rash on both of my arms. I now have what I think is considered, "COVID Arm". There is a red circle around the injection site that is swollen, red, and tender. I then noticed the inside of my mouth was sore and I had blisters developing on the roof of my mouth near my gums. My throat is super sore and swollen and has a yellow pocket on the back of my throat. I am also having body aches under my arms near my ribs and back.
Age: 23.0
Sex: F
Vaccine: COVID19
Symptoms: Pruritus, Rash
Clinical narrative: Ever since I received the vaccine, my arm has been extremely sore. Over the next few days, I became incredibly itchy and developed a rash on both of my arms. I now have what I think is considered, "COVID Arm". There is a red circle around the injection site that is swollen, red, and tender. I then noticed the inside of my mouth was sore and I had blisters developing on the roof of my mouth near my gums. My throat is super sore and swollen and has a yellow pocket on the back of my throat. I am also having body aches under my arms near my ribs and back.
Age: 96.0
Sex: M
Vaccine: COVID19
Symptoms: Extra dose administered, No adverse event
Clinical narrative: No adverse event suffered. Due to improper record keeping upon the facility, the patient received a 3rd dose of a vaccine that only requires 2 doses.  Followed up with the facility to check on the patient after one day and after one week. no adverse events reported. Facility does not believe the patient received a third dose.
Age: 83.0
Sex: M
Vaccine: COVID19
Symptoms: Death
Clinical narrative: Death, 2-17-21 at 1802 hours
Age: 15.0
Sex: F
Vaccine: COVID19
Symptoms: No adverse event, Product administered to patient of inappropriate age
Clinical narrative: Vaccination was administered without adverse event at COVID-19 clinic.  Individual was noted to be a healthcare volunteer.  Upon  logging person into tracking process for scheduling a second dose appointment, it was identified that this recipient was under the age of 16, not in the correct age range for vaccination with the Pfizer BioNtech COVID19 vaccine.
Age: 62.0
Sex: F
Vaccine: COVID19
Symptoms: Back pain, Chills, Dizziness, Fatigue, Lymphadenopathy
Clinical narrative: Initial Events - started morning 2/15/21 - dizziness, lightheadedness, fatigue, nausea, chills - resolved by 6pm 2/16/21.  Subsequent Event - started morning 2/16/21 - leg pain in calf area and formation of lump in armpit of right arm.  Leg pain migrating to upper rear of legs and into lower back  from 2/16/21 to 2/18/21.  These events are ongoing and unresolved.
Age: 62.0
Sex: F
Vaccine: COVID19
Symptoms: Nausea, Pain in extremity
Clinical narrative: Initial Events - started morning 2/15/21 - dizziness, lightheadedness, fatigue, nausea, chills - resolved by 6pm 2/16/21.  Subsequent Event - started morning 2/16/21 - leg pain in calf area and formation of lump in armpit of right arm.  Leg pain migrating to upper rear of legs and into lower back  from 2/16/21 to 2/18/21.  These events are ongoing and unresolved.
Age: 38.0
Sex: F
Vaccine: COVID19
Symptoms: Intervertebral disc disorder, Magnetic resonance imaging brain abnormal, Magnetic resonance imaging spinal abnormal, Muscular weakness, Paraesthesia
Clinical narrative: 3 days after the second Moderna vaccine patient developed right arm and leg weakness, tingling over the whole body
Age: 38.0
Sex: F
Vaccine: COVID19
Symptoms: White matter lesion
Clinical narrative: 3 days after the second Moderna vaccine patient developed right arm and leg weakness, tingling over the whole body
Age: 75.0
Sex: M
Vaccine: COVID19
Symptoms: Anal incontinence, Asthenia, Decreased appetite, Diarrhoea, Loss of consciousness
Clinical narrative: 26 hours after receiving the injection, I became very nauseous and had diarrhea.  At one time I passed out and when I woke up I was  covered in feces and vomit.  The symptoms remained until about 3:00 a.m. on the 18th of this month.  Today, the 18th, the vomiting and diarrhea subsided; but I remain very weak; and I have no appetite.
Age: 75.0
Sex: M
Vaccine: COVID19
Symptoms: Nausea, Vomiting
Clinical narrative: 26 hours after receiving the injection, I became very nauseous and had diarrhea.  At one time I passed out and when I woke up I was  covered in feces and vomit.  The symptoms remained until about 3:00 a.m. on the 18th of this month.  Today, the 18th, the vomiting and diarrhea subsided; but I remain very weak; and I have no appetite.
Age: 63.0
Sex: U
Vaccine: COVID19
Symptoms: Abdominal discomfort, Asthenia, Babesiosis, Culture stool negative, Diarrhoea
Clinical narrative: Received 2nd vaccine dose 1/11 and started with GI symptoms 1/13. 1/14 had covid and flu test, tested negative for both. She had stool culture ? normal flora, negative for c-diff, camphobacter, shigella, echoli and salmonella.  Was started on flaggyl 1/20 and taking prescription strength probiotics.  Other than diarrhea having no symptoms. Had 5-6 episodes in a day, slowly reducing. Feels little bit weak and tired from the diarrhea ? has been doing BRAT diet. Rx viral gastroenteritis, babesiosis (likely latent). Travelled to upper Midwest in 2020. Energy and strength better + back to work on modified schedule with restrictions. Being treated currently for babesiosis.
Age: 63.0
Sex: U
Vaccine: COVID19
Symptoms: Faecal calprotectin increased, Fatigue, Gastroenteritis, Influenza virus test negative, Liver function test increased
Clinical narrative: Received 2nd vaccine dose 1/11 and started with GI symptoms 1/13. 1/14 had covid and flu test, tested negative for both. She had stool culture ? normal flora, negative for c-diff, camphobacter, shigella, echoli and salmonella.  Was started on flaggyl 1/20 and taking prescription strength probiotics.  Other than diarrhea having no symptoms. Had 5-6 episodes in a day, slowly reducing. Feels little bit weak and tired from the diarrhea ? has been doing BRAT diet. Rx viral gastroenteritis, babesiosis (likely latent). Travelled to upper Midwest in 2020. Energy and strength better + back to work on modified schedule with restrictions. Being treated currently for babesiosis.
Age: 63.0
Sex: U
Vaccine: COVID19
Symptoms: Norovirus test, SARS-CoV-2 antibody test negative
Clinical narrative: Received 2nd vaccine dose 1/11 and started with GI symptoms 1/13. 1/14 had covid and flu test, tested negative for both. She had stool culture ? normal flora, negative for c-diff, camphobacter, shigella, echoli and salmonella.  Was started on flaggyl 1/20 and taking prescription strength probiotics.  Other than diarrhea having no symptoms. Had 5-6 episodes in a day, slowly reducing. Feels little bit weak and tired from the diarrhea ? has been doing BRAT diet. Rx viral gastroenteritis, babesiosis (likely latent). Travelled to upper Midwest in 2020. Energy and strength better + back to work on modified schedule with restrictions. Being treated currently for babesiosis.
Age: 80.0
Sex: F
Vaccine: COVID19
Symptoms: Blood pressure increased, Electrocardiogram normal, Paraesthesia
Clinical narrative: 80 y/o F presents for tingling sensation to B/L hands and high blood pressure after receiving the 2nd dose of the Covid-19. Patient was taken to the ED for monitoring; she denied any allergic reaction, CP, fever, chills, lightheadedness, dizziness, N/V/D/C, abdominal pain or other symptoms aside from tingling of all fingers. Her blood pressure was 197/92 at the time. EKG was performed, which was normal. No medications were administered. After 2 hours, the blood pressure normalized to 140/80 and patient was discharged.
Age: 65.0
Sex: F
Vaccine: COVID19
Symptoms: Diarrhoea, Pruritus, Rash
Clinical narrative: Generalized  itchiness that started  on the day after the shot. It?s almost 6 days now and the itchiness did not go away. I have been  alternating Benadryl , Zyrtec and Pepcid Ac. Find relief from itchiness but did not completely went away. I only had one elevated  rash on my shoulder but went away next day. I also experienced diarrhea but it stopped after two days. The one that concerns me  the most is the prolonged itchiness .
Age: 70.0
Sex: F
Vaccine: COVID19
Symptoms: Injection site pruritus, Injection site rash, Injection site swelling
Clinical narrative: Itchy, swollen injection site with surrounding rash.,
Age: 84.0
Sex: F
Vaccine: COVID19
Symptoms: Condition aggravated, Death, Dementia, Mental impairment, Pyrexia
Clinical narrative: First dose Pfizer given at assisted living on 1/14/21 she was subsequently admitted to hospital and got her second dose but Moderna was given instead of Pfizer on 2/8/21. She had been improving but in the days following the Moderna vaccine she developed fever and then her mental status declined. She was discharged back to assisted living. Suspected UTI, and moderate dementia, placed on hospice (2/12/21). Died on 2/13/21.
Age: 84.0
Sex: F
Vaccine: COVID19
Symptoms: Urinary tract infection, Wrong product administered
Clinical narrative: First dose Pfizer given at assisted living on 1/14/21 she was subsequently admitted to hospital and got her second dose but Moderna was given instead of Pfizer on 2/8/21. She had been improving but in the days following the Moderna vaccine she developed fever and then her mental status declined. She was discharged back to assisted living. Suspected UTI, and moderate dementia, placed on hospice (2/12/21). Died on 2/13/21.
Age: 1.0
Sex: U
Vaccine: HEPA
Symptoms: Product storage error
Clinical narrative: no additional AE reported; Vaqta involved in temperature excursion on 01/01/2021. Vaccine had been administered to 33 patients; This spontaneous report was received from a medical assistant and refers to a 12-month-old patient of unknown gender. The patient's pertinent medical history, drug reactions and concomitant therapies were not provided.   On 05-JAN-2021, the patient was vaccinated with an improperly stored hepatitis A vaccine, inactivated (VAQTA) lot # T013204 has been verified to be a valid lot number, with expiration date reported as 03-DEC-2021 (strength, exact dose, dose #, anatomical location and route of administration were not reported) as prophylaxis. Administered dose of vaccine experienced a temperature excursion of 47.01 degrees Fahrenheit for 1 minute and 30 seconds on 01-JAN-2021. Digital data logger was involved. There was no previous excursion noted. There was no additional adverse event reported.  This is one of 33 reports from the same reporter (original case # 2102USA004059). combinationproductreport: Yes; brandname: VAQTA SYRINGE (DEVICE); commondevicename: Hepatitis A Vaccine, Inactivated; productcode: FMF; devicetype: SYRINGE, PISTON (FMF); manufacturername: devicelotnumber: T013204; expirationdate: 03-DEC-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; Sender's Comments:  US-009507513-2102USA004059:
Age: 4.0
Sex: U
Vaccine: HEPA
Symptoms: Product storage error
Clinical narrative: no additional AE reported; Vaqta involved in temperature excursion on 01/01/2021. Vaccine had been administered to 33 patients; This spontaneous report was received from a medical assistant and refers to a 4-year-old patient of unknown gender. The patient's pertinent medical history, drug reactions and concomitant therapies were not provided.   On 07-JAN-2021, the patient was vaccinated with an improperly stored hepatitis A vaccine, inactivated (VAQTA) lot # T013204 has been verified to be a valid lot number, with expiration date reported as 03-DEC-2021 (strength, exact dose, dose #, anatomical location and route of administration were not reported) as prophylaxis. Administered dose of vaccine experienced a temperature excursion of 47.01 degrees Fahrenheit for 1 minute and 30 seconds on 01-JAN-2021. Digital data logger was involved. There was no previous excursion noted. There was no additional adverse event reported.  This is one of 33 reports from the same reporter (original case # 2102USA004059).  combinationproductreport: Yes; brandname: VAQTA SYRINGE (DEVICE); commondevicename: Hepatitis A Vaccine, Inactivated; productcode: FMF; devicetype: SYRINGE, PISTON (FMF); manufacturername: Merck Sharp & Dohme Corp; devicelotnumber: T013204; expirationdate: 03-DEC-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; Sender's Comments:  US-009507513-2102USA004059:
Age: 1.42
Sex: U
Vaccine: HEPA
Symptoms: Product storage error
Clinical narrative: no additional AE reported; Vaqta involved in temperature excursion on 01/01/2021. Vaccine had been administered to 33 patients; This spontaneous report was received from a medical assistant and refers to a 17-month-old patient. There was no information about the patient's concurrent conditions, concomitant therapies or medical history provided.  On 07-JAN-2021, the patient was vaccinated with hepatitis a vaccine, inactivated (VAQTA) lot # T013204, expiration date was not provided, but upon internal validation process it was established as 03-DEC-2021 (dose, route of administration and anatomical location were not provided) for prophylaxis. Administered dose of vaccine experienced the temperature excursion of 47.01 Fahrenheit (F) for 1 minute 30 secundes. Data logger was involved. There were no previous excursions reported. No additional adverse events were reported. combinationproductreport: Yes; brandname: VAQTA SYRINGE (DEVICE); commondevicename: Hepatitis A Vaccine, Inactivated; productcode: FMF; devicetype: SYRINGE, PISTON (FMF); manufacturername:  devicelotnumber: T013204; expirationdate: 03-DEC-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; Sender's Comments:  US-009507513-2102USA003923: US-009507513-2102USA004059:
Sex: U
Vaccine: HIBV
Symptoms: Product storage error
Clinical narrative: No additional AE; was improperly stored and administered/ BELOW 36 Farenheit degrees/ ABOVE 47 Farenheit degrees; This spontaneous report was received from a medical assistant and refers to a patient of an unknown age and gender. No information regarding the patient's medical history, concurrent conditions and concomitant medications was provided. On 07-DEC-2020, the patient was vaccinated with incorrectly stored haemophilus b conjugate vaccine (meningococcal protein conjugate) (LIQUID PEDVAXHIB) 0.5 ml, lot # T011167 with expiration date on 27-MAY-2022 (route of administration was unknown) for prophylaxis. The vaccine underwent an excursion of 35.7 degrees Fahrenheit for 1 hour and 30 minutes and 64.36 degrees Fahrenheit for 3 hours. Digital data logger was involved. No adverse event was reported.
Age: 61.0
Sex: F
Vaccine: VARZOS
Symptoms: Fatigue, Malaise
Clinical narrative: she felt run down; This case was reported by a consumer and described the occurrence of unwell in a 61-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   On 2nd June 2020, the patient received the 1st dose of Shingrix. On 3rd June 2020, 1 days after receiving Shingrix, the patient experienced unwell. On 4th June 2020, the outcome of the unwell was recovered/resolved.   It was unknown if the reporter considered the unwell to be related to Shingrix.  Additional information was provided as follows: The next day of receiving vaccine, the patient felt run down but resolved after one day. The reporter did not consent to follow up. For tolerance of 2nd dose, refer case US2020252523.; Sender's Comments:  US-GLAXOSMITHKLINE-US2020252523:same reporter
Sex: M
Vaccine: VARZOS
Symptoms: Asthma, Influenza like illness, Malaise, Upper respiratory tract infection
Clinical narrative: Acute upper respiratory infection; asthma attack; flu like sympthoms; malaise; This case was reported by a physician via other manufacturer and described the occurrence of acute upper respiratory tract infection in a 60-year-old 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, unknown after receiving Shingrix, the patient experienced acute upper respiratory tract infection, asthmatic attack, influenza-like symptoms and malaise. On an unknown date, the outcome of the acute upper respiratory tract infection, asthmatic attack, influenza-like symptoms and malaise were unknown.   It was unknown if the reporter considered the acute upper respiratory tract infection, asthmatic attack, influenza-like symptoms and malaise to be related to Shingrix.  Additional details were provided as follows: The patient received dose of  shingrix and experienced acute upper respiratory tract infection, asthmatic attack, influenza-like symptoms and malaise. The information regarding consent to follow up was not reported.
Age: 54.0
Sex: M
Vaccine: VARZOS
Symptoms: Chills, Fatigue, Malaise, Myalgia, Pyrexia
Clinical narrative: fever; chills; muscle pain; extreme fatigue; felt like someone punched him and threw him down the street; This case was reported by a consumer and described the occurrence of fever in a 54-year-old male patient who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included Shingrix with an associated reaction of pyrexia (1st dose received on 23rd September 2020 and also had fatigue, muscle pain and chills, refer case US2021013449).   On 16th December 2020, the patient received the 2nd dose of Shingrix. In January 2021, less than 2 months after receiving Shingrix, the patient experienced fever, chills, muscle pain, fatigue and feeling unwell. Rechallenge with Shingrix was positive. On an unknown date, the outcome of the fever, chills, muscle pain, fatigue and feeling unwell were recovered/resolved.   It was unknown if the reporter considered the fever, chills, muscle pain, fatigue and feeling unwell to be related to Shingrix.  Additional details were provided as follows: The case was reported by patient himself. The patient experienced the same side effects fever, chills, muscle pain, fatigue with greater intensity. The patient had to put on an electric blanket with heat and he felt like someone punched him and threw him down the street. All the adverse events were recovered after 3 days. The reporter consented to follow up. This case was linked with case US2021013454, reported by the same reporter; Sender's Comments:  US-GLAXOSMITHKLINE-US2021013454:same reporter US-GLAXOSMITHKLINE-US2021013454:same reporter
Age: 54.0
Sex: M
Vaccine: VARZOS
Symptoms: Vaccine positive rechallenge
Clinical narrative: fever; chills; muscle pain; extreme fatigue; felt like someone punched him and threw him down the street; This case was reported by a consumer and described the occurrence of fever in a 54-year-old male patient who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included Shingrix with an associated reaction of pyrexia (1st dose received on 23rd September 2020 and also had fatigue, muscle pain and chills, refer case US2021013449).   On 16th December 2020, the patient received the 2nd dose of Shingrix. In January 2021, less than 2 months after receiving Shingrix, the patient experienced fever, chills, muscle pain, fatigue and feeling unwell. Rechallenge with Shingrix was positive. On an unknown date, the outcome of the fever, chills, muscle pain, fatigue and feeling unwell were recovered/resolved.   It was unknown if the reporter considered the fever, chills, muscle pain, fatigue and feeling unwell to be related to Shingrix.  Additional details were provided as follows: The case was reported by patient himself. The patient experienced the same side effects fever, chills, muscle pain, fatigue with greater intensity. The patient had to put on an electric blanket with heat and he felt like someone punched him and threw him down the street. All the adverse events were recovered after 3 days. The reporter consented to follow up. This case was linked with case US2021013454, reported by the same reporter; Sender's Comments:  US-GLAXOSMITHKLINE-US2021013454:same reporter US-GLAXOSMITHKLINE-US2021013454:same reporter
Sex: U
Vaccine: VARZOS
Symptoms: Facial pain
Clinical narrative: Face is still sore; This case was reported by a consumer via interactive digital media and described the occurrence of facial pain in a adult patient who received Herpes zoster (Shingrix) for prophylaxis.   On an unknown date, the patient received Shingrix. On an unknown date, less than a year after receiving Shingrix, the patient experienced facial pain. On an unknown date, the outcome of the facial pain was unknown.   It was unknown if the reporter considered the facial pain to be related to Shingrix.  Additional details were provided as follows: The age at vaccination was not reported. The patient received dose of shingrix and experienced face was still sore. The age group was not reported but it was selected as adult as per vaccine indication. The patient received shot of clovis, had no side effects. The information regarding consent to follow was not reported.
Sex: F
Vaccine: VARZOS
Symptoms: Computerised tomogram head, Computerised tomogram head normal, Dermatochalasis, Facial asymmetry, Inappropriate schedule of product administration
Clinical narrative: preseptal cellulitis/left facial cellulitis; facial asymmetry; sagging of left upper lid; This case was reported by a physician via call center representative and described the occurrence of preseptal cellulitis in a 55-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included Shingrix with an associated reaction of periorbital cellulitis (1st dose received in December 2019, refer case US2021018328).   In July 2020, the patient received the 2nd dose of Shingrix. In July 2020, 1 week after receiving Shingrix, the patient experienced preseptal cellulitis (serious criteria GSK medically significant). On an unknown date, the patient experienced facial asymmetry and sagging eyelid skin. The patient was treated with amoxicillin sodium, potassium clavulanate (Augmentin) and sulfamethoxazole + trimethoprim (Bactrim). Rechallenge with Shingrix was positive. In August 2020, the outcome of the preseptal cellulitis was resolved with sequelae. On an unknown date, the outcome of the facial asymmetry and sagging eyelid skin were not recovered/not resolved.   The reporter considered the preseptal cellulitis to be almost certainly related to Shingrix. It was unknown if the reporter considered the facial asymmetry and sagging eyelid skin to be related to Shingrix.  Additional details were reported as follows: The age at vaccination was not reported but could be 54 or 55 years. The physician stated that because of COVID epidemics the delivery of the 2nd dose was delayed till July 2020/ some 6 months later. The patient about 1 week later of vaccination, developed preseptal cellulitis and was treated successfully with combination of oral Bactrim and Augmentin for 10 days. The physician stated that less than 9 months after receiving Shingrix, some facial asymmetry and sagging of left upper lid persisted. In August 2020, CT brain done had not revealed any significant abnormalities. The physician stated that the patient never suffered preseptal cellulitis before or after these two episodes. The reporter consented to follow-up.; Sender's Comments:  US-GLAXOSMITHKLINE-US2021018328:Same reporter
Sex: F
Vaccine: VARZOS
Symptoms: Periorbital cellulitis
Clinical narrative: preseptal cellulitis/left facial cellulitis; facial asymmetry; sagging of left upper lid; This case was reported by a physician via call center representative and described the occurrence of preseptal cellulitis in a 55-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included Shingrix with an associated reaction of periorbital cellulitis (1st dose received in December 2019, refer case US2021018328).   In July 2020, the patient received the 2nd dose of Shingrix. In July 2020, 1 week after receiving Shingrix, the patient experienced preseptal cellulitis (serious criteria GSK medically significant). On an unknown date, the patient experienced facial asymmetry and sagging eyelid skin. The patient was treated with amoxicillin sodium, potassium clavulanate (Augmentin) and sulfamethoxazole + trimethoprim (Bactrim). Rechallenge with Shingrix was positive. In August 2020, the outcome of the preseptal cellulitis was resolved with sequelae. On an unknown date, the outcome of the facial asymmetry and sagging eyelid skin were not recovered/not resolved.   The reporter considered the preseptal cellulitis to be almost certainly related to Shingrix. It was unknown if the reporter considered the facial asymmetry and sagging eyelid skin to be related to Shingrix.  Additional details were reported as follows: The age at vaccination was not reported but could be 54 or 55 years. The physician stated that because of COVID epidemics the delivery of the 2nd dose was delayed till July 2020/ some 6 months later. The patient about 1 week later of vaccination, developed preseptal cellulitis and was treated successfully with combination of oral Bactrim and Augmentin for 10 days. The physician stated that less than 9 months after receiving Shingrix, some facial asymmetry and sagging of left upper lid persisted. In August 2020, CT brain done had not revealed any significant abnormalities. The physician stated that the patient never suffered preseptal cellulitis before or after these two episodes. The reporter consented to follow-up.; Sender's Comments:  US-GLAXOSMITHKLINE-US2021018328:Same reporter
Age: 88.0
Sex: F
Vaccine: VARZOS
Symptoms: Herpes zoster
Clinical narrative: Shingles after dose one; This case was reported by a pharmacist and described the occurrence of shingles in a adult female patient who received Herpes zoster (Shingrix) (batch number B334Y, expiry date unknown) for prophylaxis.   The patient's past medical history included cancer and shingles.   On 17th July 2018, the patient received the 1st dose of Shingrix (intramuscular). On an unknown date, less than 4 months after receiving Shingrix, the patient experienced shingles. On an unknown date, the outcome of the shingles was recovered/resolved.   It was unknown if the reporter considered the shingles to be related to Shingrix.  Additional details were provided as follows: The age at vaccination was not reported. The patient received 1st dose of Shingrix and experienced shingles. The reporter consented to follow up. For tolerance of 2nd dose refer case US2021AMR013246.; Sender's Comments:  US-GLAXOSMITHKLINE-US2021AMR013246:Same reporter.
Sex: F
Vaccine: COVID19
Symptoms: Cough, Dizziness, Dry throat, Hypersensitivity, Oxygen saturation
Clinical narrative: Moderate allergic reaction; Felt light headed and dizzy; Cough; dry throat; Scratchy throat; Nose Tingling; did not sleep well; O2 saturation levels fluctuating from 97-86; A spontaneous report was received from nurse concerning a 56-year-old female patient who felt lightheaded and dizzy and experienced moderate allergic reaction, cough, nose tingling, dry and scratchy throat, unwell sleep, and oxygen saturation fluctuations.  The patient has past medical history of Chronic obstructive pulmonary disease (COPD) and emphysema. No relevant concomitant medications were reported.  On 29 Dec 2020, the patient received their first of two planned doses of mRNA-1273, for prophylaxis of COVID-19 infection.  On 29 Dec 2020, immediately after the vaccine shot, she felt lightheaded and dizzy. She experienced nose tingling, cough and her throat was dry and scratchy. Her symptoms were considered severe by clinic staff and the patient was taken to the emergency Room (ER). Her oxygen levels were reported to be fluctuating from 97-86. The reaction was considered a moderate allergic reaction. Treatment with diphenhydramine and steroid shot was given. The patient condition improved and was discharged from the ER with prescription for steroid taper. The patient did not sleep well and did not contact the provider about any symptoms.  Action taken with mRNA-1273 in response to the events was not reported.  The outcome for the events, moderate allergic reaction, felt lightheaded and dizzy, cough, nose tingling, dry and scratchy throat, unwell sleep, and oxygen saturation fluctuation was unknown.  The causality assessment for the events, moderate allergic reaction, felt lightheaded and dizzy, cough, nose tingling, dry and scratchy throat, unwell sleep, and oxygen saturation fluctuation was not provided.; Reporter's Comments: This case concerns a 56-year-old female patient with a  relevant medical history of COPD and emphysema who received their first of two planned doses of mRNA-1273 (Lot 041L20A) intramuscularly in the left arm for prophylaxis of COVID-19 infection. Patient experienced the serious unlisted event of Hypersensitivity, and non--serious unlisted event of Dizziness, Cough, Dry throat, Throat irritation, Poor quality sleep, and Oxygen saturation decreased. The events occurred on the same day after first dose of mRNA-1273, lot # unknown. Treatment for the events included diphenhydramine and steroid shot. Based on the temporal association between the use of the product and the events occurring after receiving the vaccine, a causal relationship cannot be excluded and the events are considered possibly related to the product.
Sex: F
Vaccine: COVID19
Symptoms: Oxygen saturation abnormal, Paraesthesia, Poor quality sleep, Throat irritation
Clinical narrative: Moderate allergic reaction; Felt light headed and dizzy; Cough; dry throat; Scratchy throat; Nose Tingling; did not sleep well; O2 saturation levels fluctuating from 97-86; A spontaneous report was received from nurse concerning a 56-year-old female patient who felt lightheaded and dizzy and experienced moderate allergic reaction, cough, nose tingling, dry and scratchy throat, unwell sleep, and oxygen saturation fluctuations.  The patient has past medical history of Chronic obstructive pulmonary disease (COPD) and emphysema. No relevant concomitant medications were reported.  On 29 Dec 2020, the patient received their first of two planned doses of mRNA-1273, for prophylaxis of COVID-19 infection.  On 29 Dec 2020, immediately after the vaccine shot, she felt lightheaded and dizzy. She experienced nose tingling, cough and her throat was dry and scratchy. Her symptoms were considered severe by clinic staff and the patient was taken to the emergency Room (ER). Her oxygen levels were reported to be fluctuating from 97-86. The reaction was considered a moderate allergic reaction. Treatment with diphenhydramine and steroid shot was given. The patient condition improved and was discharged from the ER with prescription for steroid taper. The patient did not sleep well and did not contact the provider about any symptoms.  Action taken with mRNA-1273 in response to the events was not reported.  The outcome for the events, moderate allergic reaction, felt lightheaded and dizzy, cough, nose tingling, dry and scratchy throat, unwell sleep, and oxygen saturation fluctuation was unknown.  The causality assessment for the events, moderate allergic reaction, felt lightheaded and dizzy, cough, nose tingling, dry and scratchy throat, unwell sleep, and oxygen saturation fluctuation was not provided.; Reporter's Comments: This case concerns a 56-year-old female patient with a  relevant medical history of COPD and emphysema who received their first of two planned doses of mRNA-1273 (Lot 041L20A) intramuscularly in the left arm for prophylaxis of COVID-19 infection. Patient experienced the serious unlisted event of Hypersensitivity, and non--serious unlisted event of Dizziness, Cough, Dry throat, Throat irritation, Poor quality sleep, and Oxygen saturation decreased. The events occurred on the same day after first dose of mRNA-1273, lot # unknown. Treatment for the events included diphenhydramine and steroid shot. Based on the temporal association between the use of the product and the events occurring after receiving the vaccine, a causal relationship cannot be excluded and the events are considered possibly related to the product.
Sex: F
Vaccine: COVID19
Symptoms: Dyskinesia, Nervous system disorder, Seizure
Clinical narrative: Nervous system disorder NOS; Severe uncontrollable body movements, my tongue was also affected; Allegedly having an adverse reaction with seizures; A spontaneous report was received from a consumer who was a 42-year-old female patient, who received Moderna's COVID-19 vaccine (mRNA-1273) and experienced attack on nervous system, severe uncontrollable body movements, and allegedly having an adverse reaction with seizures.  The patient's medical history, as provided by the reporter, included hysterectomy.  No concomitant medications were provided.  On 04 Jan 2021, the patient received their first of two planned doses of mRNA-1273 (Lot Number: 011L20A) for prophylaxis of COVID-19 infection.   On 07 Jan 2021, the patient's tongue began to spasm.  On 08 Jan 2021, the patient's whole body had been convulsing all day.  The patient reported that it was attacking her nervous system on an undisclosed date.  She visited four hospitals in two days; all blood work was normal. No treatment information was provided.  Action taken with mRNA-1273 in response to the events was not reported.   The outcome of the events, attack on nervous system, severe uncontrollable body movements, and allegedly having an adverse reaction with seizures, was considered not recovered/not resolved.; Reporter's Comments: This case concerns a 42-year-old, female patient with medical history of hysterectomy, who experienced serious, unexpected event of seizures and non-serious, unexpected event of dyskinesia and nervous system disorder NOS. The events occurred 4 days after the first dose of mRNA-1273 (Lot Number: 011L20A) administration. Very limited information regarding this event has been provided at this time.  Based on temporal association between the use of the product and the start date of the event, a causal relationship cannot be excluded.
Sex: M
Vaccine: COVID19
Symptoms: Death
Clinical narrative: Died the next day; A spontaneous report was received from a consumer concerning a male patient who received Moderna's COVID-19 vaccine (mRNA-1273) and died the next day.     The patient's medical history was not provided. Concomitant medication use was not provided by the reporter.   On 12 Jan 2021, approximately one day prior to the event, the patient received one of two planned doses of mRNA-1273 intramuscularly for prophylaxis of COVID-19 infection.   On 13 Jan 2021 the patient died. No additional information was provided in regards to the event.   Action taken with mRNA-1273 in response to the event was not applicable.   The patient died on 13 Jan 2021. The cause of death was unknown.; Reporter's Comments: This case concerns a male patient of unknown age. The medical history and concomitant medication were not provided. The patient died approximately one day after receiving their first of two planned doses of mRNA-1273 (Lot unknown). Very limited information regarding this event has been provided at this time.; Reported Cause(s) of Death: Unknown cause of death
Sex: M
Vaccine: COVID19
Symptoms: Body temperature, Chills, Dehydration, Dyspnoea, Heart rate
Clinical narrative: Heart rate 145 beats per min; Shortness of breath; Panic attack; Severe dehydration; Cannot quench thirst; Numb tongue and mouth; Fever of 104 F; Aches; Chills; A spontaneous report was received from a consumer concerning a male patient who received Moderna's COVID-19 Vaccine (mRNA-1273) and experienced heart rate 145 beats per min (bpm), fever of 104F, shortness of breath, panic attack, severe dehydration, cannot quench his thirst, numb tongue, numb mouth, aches and chills.  The patient's medical history was not provided. No relevant concomitant medications were reported.   On an unknown date, the patient received a dose of mRNA-1273 intramuscularly for prophylaxis of COVID-19 infection.  On an unknown date, the patient experienced a fever of 104 F, elevated heart rate of 145 bpm, severe dehydration, cannot quench his thirst, numb tongue and moth for 3 days and aches and chills for 3 days. He sought medical attention at his doctor's office. A urinalysis was completed which resulted normal. No treatment information was provided.  Action taken with mRNA-1273 in response to the events was not reported.  The events, heart rate 145 beats per min, fever of 104F, shortness of breath, panic attack, severe dehydration, cannot quench his thirst, numb tongue, numb mouth, aches and chills, were considered resolved on an unknown date.; 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.
Sex: M
Vaccine: COVID19
Symptoms: Hypoaesthesia oral, Pain, Panic attack, Pyrexia, Tachycardia
Clinical narrative: Heart rate 145 beats per min; Shortness of breath; Panic attack; Severe dehydration; Cannot quench thirst; Numb tongue and mouth; Fever of 104 F; Aches; Chills; A spontaneous report was received from a consumer concerning a male patient who received Moderna's COVID-19 Vaccine (mRNA-1273) and experienced heart rate 145 beats per min (bpm), fever of 104F, shortness of breath, panic attack, severe dehydration, cannot quench his thirst, numb tongue, numb mouth, aches and chills.  The patient's medical history was not provided. No relevant concomitant medications were reported.   On an unknown date, the patient received a dose of mRNA-1273 intramuscularly for prophylaxis of COVID-19 infection.  On an unknown date, the patient experienced a fever of 104 F, elevated heart rate of 145 bpm, severe dehydration, cannot quench his thirst, numb tongue and moth for 3 days and aches and chills for 3 days. He sought medical attention at his doctor's office. A urinalysis was completed which resulted normal. No treatment information was provided.  Action taken with mRNA-1273 in response to the events was not reported.  The events, heart rate 145 beats per min, fever of 104F, shortness of breath, panic attack, severe dehydration, cannot quench his thirst, numb tongue, numb mouth, aches and chills, were considered resolved on an unknown date.; 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.
Sex: M
Vaccine: COVID19
Symptoms: Thirst, Urine analysis
Clinical narrative: Heart rate 145 beats per min; Shortness of breath; Panic attack; Severe dehydration; Cannot quench thirst; Numb tongue and mouth; Fever of 104 F; Aches; Chills; A spontaneous report was received from a consumer concerning a male patient who received Moderna's COVID-19 Vaccine (mRNA-1273) and experienced heart rate 145 beats per min (bpm), fever of 104F, shortness of breath, panic attack, severe dehydration, cannot quench his thirst, numb tongue, numb mouth, aches and chills.  The patient's medical history was not provided. No relevant concomitant medications were reported.   On an unknown date, the patient received a dose of mRNA-1273 intramuscularly for prophylaxis of COVID-19 infection.  On an unknown date, the patient experienced a fever of 104 F, elevated heart rate of 145 bpm, severe dehydration, cannot quench his thirst, numb tongue and moth for 3 days and aches and chills for 3 days. He sought medical attention at his doctor's office. A urinalysis was completed which resulted normal. No treatment information was provided.  Action taken with mRNA-1273 in response to the events was not reported.  The events, heart rate 145 beats per min, fever of 104F, shortness of breath, panic attack, severe dehydration, cannot quench his thirst, numb tongue, numb mouth, aches and chills, were considered resolved on an unknown date.; 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.