chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 57.0
Sex: F
Vaccine: COVID19
Symptoms: Burning sensation, Fatigue, Headache, Influenza, Myalgia
Clinical narrative: Muscle pain, headache, flu feeling, fatigue, rash, itch, burning
Age: 57.0
Sex: F
Vaccine: COVID19
Symptoms: Pruritus, Rash
Clinical narrative: Muscle pain, headache, flu feeling, fatigue, rash, itch, burning
Age: 60.0
Sex: M
Vaccine: COVID19
Symptoms: COVID-19, SARS-CoV-2 test positive
Clinical narrative: on 4/23/21 patient phoned the pharmacy to say he had tested positive for covid 19
Age: 76.0
Sex: M
Vaccine: COVID19
Symptoms: Bilevel positive airway pressure, Blood gases abnormal, Chest X-ray abnormal, Death, Electrocardiogram normal
Clinical narrative: Pt  received his 2nd moderna covid vaccine on 4/16/2021. admitted on 4/22/2021 from his long term care facility due to concerns for a chf exacerbation and acute on chronic respiratory failure. Pt was given IV Lasix. chest x ray showed mild pulm vascular congestion. there was no hypoxia, tachycardia and pt was on eliquis so pe was felt to not be a possibility.  abg showed acute respiratory acidosis with hypercapnia which improved with bipap administration. His troponins and ekg were negative. vitals on arrival were stable. He was admitted. Labs were otherwise unremarkable. Pt began to have pauses on telemetry and was last seen awake and alert but when nursing staff went back to check on him minutes later he was found deceased
Age: 76.0
Sex: M
Vaccine: COVID19
Symptoms: Full blood count normal, Hypercapnia, Pulmonary congestion, Respiratory acidosis, Troponin normal
Clinical narrative: Pt  received his 2nd moderna covid vaccine on 4/16/2021. admitted on 4/22/2021 from his long term care facility due to concerns for a chf exacerbation and acute on chronic respiratory failure. Pt was given IV Lasix. chest x ray showed mild pulm vascular congestion. there was no hypoxia, tachycardia and pt was on eliquis so pe was felt to not be a possibility.  abg showed acute respiratory acidosis with hypercapnia which improved with bipap administration. His troponins and ekg were negative. vitals on arrival were stable. He was admitted. Labs were otherwise unremarkable. Pt began to have pauses on telemetry and was last seen awake and alert but when nursing staff went back to check on him minutes later he was found deceased
Age: 39.0
Sex: F
Vaccine: COVID19
Symptoms: Asthenia, Confusional state, Decreased appetite, Disturbance in attention, Dizziness
Clinical narrative: Nausea for about 72 hours, weakness, tiredness, confusion, inability to concentrate on work, dizzy, lack of appetite
Age: 39.0
Sex: F
Vaccine: COVID19
Symptoms: Nausea
Clinical narrative: Nausea for about 72 hours, weakness, tiredness, confusion, inability to concentrate on work, dizzy, lack of appetite
Age: 17.0
Sex: M
Vaccine: HEP
Symptoms: No adverse event, Product administered to patient of inappropriate age
Clinical narrative: Administrated  an adult dose of Engerix-B   to a 17 years old; Administrated  an adult dose of Engerix-B   to a 17 years old; This case was reported by a pharmacist via call center representative and described the occurrence of adult product administered to child in a 17-year-old male patient who received HBV (Engerix B adult) (batch number 5NY2K, expiry date 29th May 2022) for prophylaxis.   On 26th February 2021, the patient received the 1st dose of Engerix B. On 26th February 2021, unknown after receiving Engerix B, the patient experienced adult product administered to child and overdose. On an unknown date, the outcome of the adult product administered to child and overdose were unknown.  Additional details were provided as follows: An adult dose of Engerix-B was administered to a 17 years old male patient which led to adult product administered to child and overdose. No adverse event was reported. The reporter did not consented to follow up.   Upon internal review, following corrections were performed on 23rd April 2021: The exclude from pader classification from general tab was removed. The suspect was updated to Engerix B adult.
Age: 60.0
Sex: M
Vaccine: COVID19
Symptoms: Dizziness, Fall, Impaired driving ability, Loss of consciousness, Loss of personal independence in daily activities
Clinical narrative: Vertigo/dizziness. Lost control and fell to the bed on the first symptom morning. Vertigo lasted for 10 days with varying, unpredictable intensity. Then, it was downgraded to occasional dizziness until now, Day 14. The vertigo restricted my movement and driving out of precaution. After reading similar experiences at website and others, started taking Ibuprofen and diphenhydramine, which helped a bit. Currently waiting for my second shot in 5 days warily.
Age: 60.0
Sex: M
Vaccine: COVID19
Symptoms: Vertigo
Clinical narrative: Vertigo/dizziness. Lost control and fell to the bed on the first symptom morning. Vertigo lasted for 10 days with varying, unpredictable intensity. Then, it was downgraded to occasional dizziness until now, Day 14. The vertigo restricted my movement and driving out of precaution. After reading similar experiences at website and others, started taking Ibuprofen and diphenhydramine, which helped a bit. Currently waiting for my second shot in 5 days warily.
Age: 44.0
Sex: F
Vaccine: COVID19
Symptoms: Joint range of motion decreased
Clinical narrative: Can't lift left arm
Age: 28.0
Sex: M
Vaccine: COVID19
Symptoms: Heart rate increased, Hypersomnia
Clinical narrative: Pt stated he felt an elevated heart rate ten minutes after dosage was administered.  Staff gave the patient bottle water to drink and monitored the patient an additional 30 minutes.  Pt called 4/23/21 stating he slept 13 hours last night but today around 2:00pm his bp was 117/55 and heart rate 121 bpm via his watch.   He states no medication, no other side effects, no history of tachycardia, no physical exam in several years.   He was advised to contact 911 if the elevated heart rate continues for over 45 minutes or go to ER or Urgent Care.
Age: 18.0
Sex: M
Vaccine: COVID19
Symptoms: Epistaxis, Full blood count
Clinical narrative: nose bleed reported 24 hours post-vaccination.  He does not typically have nose bleeds, a rare occurrence for him to have one.  He was able to get it to stop within 10 minutes with pressure.
Age: 37.0
Sex: M
Vaccine: COVID19
Symptoms: Headache, Visual impairment
Clinical narrative: Severe headache x 5 days affecting ability to see and complete daily activities
Age: 55.0
Sex: M
Vaccine: COVID19
Symptoms: Body temperature increased, Discomfort, Injection site erythema, Myalgia, Pain
Clinical narrative: At 2:15 am the day after the vaccine, I woke up with a sore left arm (injection site), redness on the left arm, muscle aches, body pain and discomfort, along with a temperature of 101 to 102 that lasted for about 3 days.  I stayed in bed and drank liquids, ate soup and took Tylenol (2 tablets every 6-8 hours) for almost 3 days until I started to feel better.
Age: 55.0
Sex: M
Vaccine: COVID19
Symptoms: Pain in extremity
Clinical narrative: At 2:15 am the day after the vaccine, I woke up with a sore left arm (injection site), redness on the left arm, muscle aches, body pain and discomfort, along with a temperature of 101 to 102 that lasted for about 3 days.  I stayed in bed and drank liquids, ate soup and took Tylenol (2 tablets every 6-8 hours) for almost 3 days until I started to feel better.
Age: 51.0
Sex: F
Vaccine: COVID19
Symptoms: Chills, Dizziness, Headache, Muscular weakness, Nausea
Clinical narrative: Dizzy, nausea, vomiting, headache, fever, chills, body aches, body tremors, left side ache and pain for weeks, dull ache in left arm and side for weeks., muscle weakness no grip strength in left side for weeks.
Age: 51.0
Sex: F
Vaccine: COVID19
Symptoms: Pain, Pyrexia, Tremor, Vomiting
Clinical narrative: Dizzy, nausea, vomiting, headache, fever, chills, body aches, body tremors, left side ache and pain for weeks, dull ache in left arm and side for weeks., muscle weakness no grip strength in left side for weeks.
Age: 31.0
Sex: M
Vaccine: COVID19
Symptoms: Chills, Fatigue, Headache, Myalgia
Clinical narrative: Chills, muscle aches, headache, and fatigue approximately 12 hours after vaccine was administered. Symptoms lasted for about 12 hours.
Age: 28.0
Sex: F
Vaccine: COVID19
Symptoms: Dyskinesia, Hypoaesthesia, Paraesthesia, Tremor
Clinical narrative: My toes have been numb or tingling for the last three days. I either don?t feel them or they?re extremely tingly so I can?t sleep well. My legs are tingly - like when you?re trying to wake your legs up after they fall asleep. On 4/20/21 the day I got the vaccine my legs were convulsing and my body was forcing itself to stretch out & when it did my whole body shook. My legs have been constantly tingling since and it hasn?t stopped in over 3 days.
Age: 36.0
Sex: F
Vaccine: COVID19
Symptoms: Oral herpes, Pyrexia, Stomatitis
Clinical narrative: Fever, fever blisters/cold sores, mouth sores
Age: 58.0
Sex: F
Vaccine: COVID19
Symptoms: Ear pain, Headache, Lymph node pain, Lymphadenopathy, Ocular discomfort
Clinical narrative: 26 hours after my second Moderna Vaccine I experienced these severe/painful symptoms: * Head felt like it was going to explode, especially forehead and back of head. Back of head felt like I was whacked with something. This did not feel like a headache, it was much worse than any head pain I have ever experienced. * My eyeballs felt like they were on fire. * Neck lymph nodes very swollen and painful. Pain radiated to my ears and jaw. Pain was so severe, I was thinking of going to emergency room. After 6 hours of excruciating pain, I took 1- 500 mg Tylenol at 9:00 pm. Pain did decrease to a bearable level in 1 hour.
Age: 58.0
Sex: F
Vaccine: COVID19
Symptoms: Pain in jaw
Clinical narrative: 26 hours after my second Moderna Vaccine I experienced these severe/painful symptoms: * Head felt like it was going to explode, especially forehead and back of head. Back of head felt like I was whacked with something. This did not feel like a headache, it was much worse than any head pain I have ever experienced. * My eyeballs felt like they were on fire. * Neck lymph nodes very swollen and painful. Pain radiated to my ears and jaw. Pain was so severe, I was thinking of going to emergency room. After 6 hours of excruciating pain, I took 1- 500 mg Tylenol at 9:00 pm. Pain did decrease to a bearable level in 1 hour.
Age: 71.0
Sex: F
Vaccine: COVID19
Symptoms: Rash
Clinical narrative: Spouse of patient called and report patient experienced a rash on her leg and elbow of the arm where is received her 2nd dose of the Moderna Vaccine approximately at 3pm.
Age: 82.0
Sex: M
Vaccine: COVID19
Symptoms: Anal incontinence, Computerised tomogram, Hypoaesthesia, Hypotonia, Laboratory test
Clinical narrative: Spinal infarct @ T 10-12, resulting in paraplegia.  Symptoms began 4 days after receiving vaccine. Leg numbness and flaccidity, loss of bowel and bladder function.
Age: 82.0
Sex: M
Vaccine: COVID19
Symptoms: Lumbar puncture, Paraplegia, Spinal cord infarction, Urinary incontinence
Clinical narrative: Spinal infarct @ T 10-12, resulting in paraplegia.  Symptoms began 4 days after receiving vaccine. Leg numbness and flaccidity, loss of bowel and bladder function.
Age: 36.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Arthralgia, Cough, Fatigue, Gastrooesophageal reflux disease, Injection site pain
Clinical narrative: Symptoms and timeline apply for both shots 1 and 2 EXCEPT FOR acid reflux only following shot 2.  Day of shot: moderate lethargy starting four hours after administration, lasting until sleep. Increasing soreness at site of shot starting one hour after. Shot day +1: woke with moderate soreness in joints, heavy muscle soreness, the latter of which lasted the whole day.  Overall feeling of fatigue, and the sensation of riding on an endlessly looping rollercoaster lasted for half the day. In the second half of the day, congested sinuses and light coughing/sneezing began, along with light acid reflux. Shot day +2: Muscle soreness mostly gone, small amount of nausea remaining in the morning. Light fatigue. Frequent coughing in the morning, and heavy acid reflux throughout the day. Shot day +3: Symptoms minimal
Age: 36.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Lethargy, Myalgia, Nausea, Sensory disturbance, Sinus congestion
Clinical narrative: Symptoms and timeline apply for both shots 1 and 2 EXCEPT FOR acid reflux only following shot 2.  Day of shot: moderate lethargy starting four hours after administration, lasting until sleep. Increasing soreness at site of shot starting one hour after. Shot day +1: woke with moderate soreness in joints, heavy muscle soreness, the latter of which lasted the whole day.  Overall feeling of fatigue, and the sensation of riding on an endlessly looping rollercoaster lasted for half the day. In the second half of the day, congested sinuses and light coughing/sneezing began, along with light acid reflux. Shot day +2: Muscle soreness mostly gone, small amount of nausea remaining in the morning. Light fatigue. Frequent coughing in the morning, and heavy acid reflux throughout the day. Shot day +3: Symptoms minimal
Age: 36.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Sneezing, Vaccine positive rechallenge
Clinical narrative: Symptoms and timeline apply for both shots 1 and 2 EXCEPT FOR acid reflux only following shot 2.  Day of shot: moderate lethargy starting four hours after administration, lasting until sleep. Increasing soreness at site of shot starting one hour after. Shot day +1: woke with moderate soreness in joints, heavy muscle soreness, the latter of which lasted the whole day.  Overall feeling of fatigue, and the sensation of riding on an endlessly looping rollercoaster lasted for half the day. In the second half of the day, congested sinuses and light coughing/sneezing began, along with light acid reflux. Shot day +2: Muscle soreness mostly gone, small amount of nausea remaining in the morning. Light fatigue. Frequent coughing in the morning, and heavy acid reflux throughout the day. Shot day +3: Symptoms minimal
Age: 20.0
Sex: F
Vaccine: COVID19
Symptoms: Dizziness, Hyperhidrosis, Pallor, Peripheral coldness
Clinical narrative: Patient complained of severe dizziness a few minutes after COVID vaccine. We had patient lie down on her back with her feet elevated. She had paleness,  coldness of extremities and sweating.  We maintain an open airway and apply cold compresses. Patient symptoms improved after 30 minutes,
Age: 21.0
Sex: F
Vaccine: COVID19
Symptoms: Dizziness, Loss of consciousness, Vomiting
Clinical narrative: Patient had lightheadedness and lost consciousness for 3-5 seconds before regaining consciousness, she then proceeded to use the bathroom to vomit, before returning to the waiting area and drinking some water.  After a few minutes, she was feeling much better.
Age: 58.0
Sex: M
Vaccine: COVID19
Symptoms: Feeling cold, Peripheral coldness
Clinical narrative: Pfizer-BioNTech COVID-19 Vaccine EUA Cold sensation in the right arm, from the shoulder to the hand.    Concern that this might be related to a blood vessel disorder with clotting problems
Age: 58.0
Sex: M
Vaccine: COVID19
Symptoms: Asthenia, Autopsy, Cardiac arrest, Chest X-ray abnormal, Cough
Clinical narrative: Patient flew from city to city through another city on Tuesday 3/16/21.  He had a reaction on the flight where he coughed for 1.5 hrs and was hot in the airplane.  He could not go to work and was required to get Covid tested on 3/18.  Still coughing and having trouble sleeping (laying down).  Rapid Covid test negative on 3/18.  PCR test results negative on 3/21 from hospital.  He continued to grow weak and cough from 3/16-3/21.  At 3am on 3/22 he called and said that his feet were 2X their size and having difficulty breathing.  Taken to hospital via ambulance.  When transfered to ER bed, Dr said that he lost pulse.  They intubated and got his pulse back. Died at 5:15am. Autopsy said cardiac arrest.  Dr said that they could not maintain a heart beat.  He asked me if the patient had a history of blood clots?  No he did not ever has a blood clot that I know of.  He had a chest xray post mortem showing fluid in his lungs from low circulation of blood.
Age: 58.0
Sex: M
Vaccine: COVID19
Symptoms: Death, Dyspnoea, Endotracheal intubation, Feeling hot, Impaired work ability
Clinical narrative: Patient flew from city to city through another city on Tuesday 3/16/21.  He had a reaction on the flight where he coughed for 1.5 hrs and was hot in the airplane.  He could not go to work and was required to get Covid tested on 3/18.  Still coughing and having trouble sleeping (laying down).  Rapid Covid test negative on 3/18.  PCR test results negative on 3/21 from hospital.  He continued to grow weak and cough from 3/16-3/21.  At 3am on 3/22 he called and said that his feet were 2X their size and having difficulty breathing.  Taken to hospital via ambulance.  When transfered to ER bed, Dr said that he lost pulse.  They intubated and got his pulse back. Died at 5:15am. Autopsy said cardiac arrest.  Dr said that they could not maintain a heart beat.  He asked me if the patient had a history of blood clots?  No he did not ever has a blood clot that I know of.  He had a chest xray post mortem showing fluid in his lungs from low circulation of blood.
Age: 58.0
Sex: M
Vaccine: COVID19
Symptoms: Insomnia, Myocardial infarction, Peripheral swelling, Poor peripheral circulation, Pulmonary oedema
Clinical narrative: Patient flew from city to city through another city on Tuesday 3/16/21.  He had a reaction on the flight where he coughed for 1.5 hrs and was hot in the airplane.  He could not go to work and was required to get Covid tested on 3/18.  Still coughing and having trouble sleeping (laying down).  Rapid Covid test negative on 3/18.  PCR test results negative on 3/21 from hospital.  He continued to grow weak and cough from 3/16-3/21.  At 3am on 3/22 he called and said that his feet were 2X their size and having difficulty breathing.  Taken to hospital via ambulance.  When transfered to ER bed, Dr said that he lost pulse.  They intubated and got his pulse back. Died at 5:15am. Autopsy said cardiac arrest.  Dr said that they could not maintain a heart beat.  He asked me if the patient had a history of blood clots?  No he did not ever has a blood clot that I know of.  He had a chest xray post mortem showing fluid in his lungs from low circulation of blood.
Age: 58.0
Sex: M
Vaccine: COVID19
Symptoms: Pulse absent, SARS-CoV-2 test negative
Clinical narrative: Patient flew from city to city through another city on Tuesday 3/16/21.  He had a reaction on the flight where he coughed for 1.5 hrs and was hot in the airplane.  He could not go to work and was required to get Covid tested on 3/18.  Still coughing and having trouble sleeping (laying down).  Rapid Covid test negative on 3/18.  PCR test results negative on 3/21 from hospital.  He continued to grow weak and cough from 3/16-3/21.  At 3am on 3/22 he called and said that his feet were 2X their size and having difficulty breathing.  Taken to hospital via ambulance.  When transfered to ER bed, Dr said that he lost pulse.  They intubated and got his pulse back. Died at 5:15am. Autopsy said cardiac arrest.  Dr said that they could not maintain a heart beat.  He asked me if the patient had a history of blood clots?  No he did not ever has a blood clot that I know of.  He had a chest xray post mortem showing fluid in his lungs from low circulation of blood.
Age: 53.0
Sex: F
Vaccine: COVID19
Symptoms: Back pain, Chest pain, Cough, Pain in extremity
Clinical narrative: PATIENT STATED SHE FELT BACK PAIN, LEG PAIN,  AND CHEST PAIN IMMEDIATELY AFTER GETTING THE VACCINE, PATIENT WAS OBSERVED FOR 15 MINUTES AND FELT WELL ENOUGH TO GO HOME; HOWEVER, PATIENT CALLED PHARMACY TODAY 4/23/21  FOR THE FIRST TIME SINCE 4/8/21 STATING HER CHEST PAIN AND LEG PAIN HAVE INCREASED SINCE GETTING THE VACCINE. PATIENT WAS COUGHING ALOT WHILE TALKING ON THE PHONE AND CRYING DUE TO THE CONCERN OF JENSSEN VACCINES IN THE NEWS. I ADVISED THE PATIENT THAT SHE SHOULD GO TO THE EMERGENCY ROOM FOR FOLLOW UP DUE TO CONCERNS OF HER EXPERIENCING CHEST PAIN AND LEG PAIN IN ORDER TO ELIMATE THE POSSIBILITY OF ANY CLOTS.
Age: 17.0
Sex: M
Vaccine: COVID19
Symptoms: Product administered to patient of inappropriate age
Clinical narrative: MODERNA COVID 19 VACCINE WAS ADMINISTERED TO A 17 YEAR OLD PATIENT, CONTACTED THE PATIENT AND DIDNT RECIEVE A RESPONSE BACK AND WILL UPDATE AND WE WILL COMPLETE AN UPDATED VAERS REPORT IF THERE ARE ANY ADVERSE EVENTS  EXPERIENCED BY THE PATIENT.
Age: 31.0
Sex: F
Vaccine: COVID19
Symptoms: Chills, Exposure during pregnancy, Multigravida, Pain, Pyrexia
Clinical narrative: Twelve hours after the vaccine I got a fever, chills and body aches which lasted 12 hours. I discovered I was pregnant three weeks after the second dose of the vaccine on Feb 9th and Miscarried on Mar 14th. I was nine weeks pregnant. I had an eight week ultrasound and the baby was small.  Due Date 10/16/2021 Pregnancy Second
Age: 73.0
Sex: M
Vaccine: COVID19
Symptoms: Dizziness, Headache
Clinical narrative: Headache & dizziness 20 days
Age: 17.0
Sex: M
Vaccine: COVID19
Symptoms: Product administered to patient of inappropriate age
Clinical narrative: Patient given 2nd dose of Moderna vaccine in accordance with protocol instructions after giving first dose to 17 year in error previously
Age: 31.0
Sex: F
Vaccine: COVID19
Symptoms: Herpes zoster, Pain in extremity
Clinical narrative: Shingles (have never had them before) and sore arm were the only two after the first shot
Age: 37.0
Sex: M
Vaccine: COVID19
Symptoms: Dizziness, Hot flush, Hyperhidrosis, Pain in extremity
Clinical narrative: Wave of lightheadedness, sweating, hot flashes that lasted less than 1 hour. Sore arm, not too severe.
Age: 27.0
Sex: F
Vaccine: COVID19
Symptoms: Asthenia, Dizziness, Immediate post-injection reaction, Malaise, Nausea
Clinical narrative: Patient immediately fell ill after injection. She was dizzy, nauseated, and weak.  Patient asked to lie on the floor.  She was breathing rapidly and looked pale.  She rested on the floor for several minutes but began to feel better once her partner entered the room with her.  He  provided comfort and stated that she normally has someone with her when she gets vaccinated because she has fainted in the past.  He said this was the first vaccine that she has had without him.  We offered ambulance service which she initially accepted but later declined once her partner entered the room and she began to feel better.
Age: 27.0
Sex: F
Vaccine: COVID19
Symptoms: Pallor, Respiratory rate increased
Clinical narrative: Patient immediately fell ill after injection. She was dizzy, nauseated, and weak.  Patient asked to lie on the floor.  She was breathing rapidly and looked pale.  She rested on the floor for several minutes but began to feel better once her partner entered the room with her.  He  provided comfort and stated that she normally has someone with her when she gets vaccinated because she has fainted in the past.  He said this was the first vaccine that she has had without him.  We offered ambulance service which she initially accepted but later declined once her partner entered the room and she began to feel better.
Sex: F
Vaccine: HEP, HEP
Symptoms: Inappropriate schedule of product administration
Clinical narrative: first Energix B / on 09/13/2020 / has not received her third dose of Energix B; first Energix B / on 09/13/2020 and her second Energix B / on 02/10/2021; This case was reported by a consumer via call center representative and described the occurrence of drug dose administration interval too long in a 57-year-old female patient who received HBV (Engerix B) for prophylaxis.   Co-suspect products included hepatitis B vaccine pre-filled syringe device (Engerix B Pre-Filled Syringe Device) injection syringe for prophylaxis, HBV (Engerix B) for prophylaxis and hepatitis B vaccine pre-filled syringe device (Engerix B Pre-Filled Syringe Device) injection syringe for prophylaxis.   Previously administered products included Engerix B with an associated reaction of migraine (received 1st dose of Engerix B on 13th September 2020, refer case US2021AMR086014).   On 10th February 2021, the patient received the 2nd dose of Engerix B. On 10th February 2021, the dose was an unknown dose. On 10th February 2021, the patient started Engerix B Pre-Filled Syringe Device. On an unknown date, the patient received the 3rd dose of Engerix B and Engerix B Pre-Filled Syringe Device. On 10th February 2021, unknown after receiving Engerix B and Engerix B Pre-Filled Syringe Device and not applicable after receiving Engerix B and Engerix B Pre-Filled Syringe Device, the patient experienced drug dose administration interval too long. On an unknown date, the patient experienced incomplete course of vaccination. On 4th April 2021, the outcome of the drug dose administration interval too long was unknown. On an unknown date, the outcome of the incomplete course of vaccination was unknown.   This report is made by GSK without prejudice and does not imply any admission or liability for the incident or its consequences.  Additional details were provided as follow: The patient had reported the case for herself. The age at vaccination was not reported, however it could be 56 or 57 years. The patient received 1st dose of Engerix on 13th Sep 2020. The patient received 2nd dose of engerix B on 10th Feb 2021. The patient was scheduled for 3rd dose of Engerix B on 15th Apr 2021. The patient was not aware of the schedule. Which leads to Drug dose administration interval too long and incomplete course of vaccination. The reporter did not consent for follow up with her health care professional. This case had been linked with US2021AMR086014 , reported by the same reporter for the same patient.; Sender's Comments:  US-GLAXOSMITHKLINE-US2021AMR086014:Same reporter
Age: 65.0
Sex: F
Vaccine: VARZOS
Symptoms: Back pain, Chills, Myalgia
Clinical narrative: diffuse muscle pain; shivering / chills; back pain; This case was reported by a consumer via call center representative and described the occurrence of muscle pain in a 65-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included Shingrix (1st dose received in 2020 on unknown date) and Covid-19 vaccine (1st dose received on unknown date). Concomitant products included covid-19 vaccine.   On 14th April 2021, the patient received the 2nd dose of Shingrix. On 14th April 2021, 8 hrs after receiving Shingrix, the patient experienced muscle pain, shivering and back pain. The patient was treated with paracetamol (Tylenol). On an unknown date, the outcome of the muscle pain and back pain were not recovered/not resolved and the outcome of the shivering was recovered/resolved.   It was unknown if the reporter considered the muscle pain, shivering and back pain to be related to Shingrix.  Additional details were provided as follows: The case was reported by the patient herself. The patient received 2nd dose of covid-19 vaccine in end of February 2021 concomitantly. The patient received the dose of Shingrix on left arm at her physician's office and 8 hours after the vaccination patient had diffuse muscle pain, shivering, chills and back pain. The patient received the 2nd dose of Shingrix later than recommended schedule. On 14th April 2021 the patient received Tylenol for treatment. The muscle pain and back pain was not resolved whereas the chill and shivering was recovered. The reporter stated that the 1st Shingrix vaccination received in 2020 but did not remember the exact date, but knew that it has been longer than 6 months. It was stated that the patient was told by her physician to delay her second dose of Shingrix so she could receive her 2 doses of Covid vaccine. The reporter consented to follow up.
Age: 81.0
Sex: F
Vaccine: VARZOS
Symptoms: Limb operation
Clinical narrative: First shingles vaccine 10/2019. She later had hand surgery; This case was reported by a consumer and described the occurrence of hand operation in a 82-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   In October 2019, the patient received the 1st dose of Shingrix. On an unknown date, less than 2 years after receiving Shingrix, the patient experienced hand operation. On an unknown date, the outcome of the hand operation was unknown.   It was unknown if the reporter considered the hand operation to be related to Shingrix.  Additional details were provided as follows: This case was reported by patient herself. The patient received 1st dose of Shingle vaccine and later had had surgery. The reporter consented to follow up. For tolerance of 2nd dose refer case US2021AMR087889. This case has been linked with US2021086467, reported by the same reporter.; Sender's Comments:  US-GLAXOSMITHKLINE-US2021086467:Same reporter US-GLAXOSMITHKLINE-US2021AMR087889:Same reporter.
Age: 56.0
Sex: F
Vaccine: VARZOS
Symptoms: Contusion, Incorrect route of product administration, Mobility decreased, Product administered at inappropriate site
Clinical narrative: given 7 inches below the deltoid region / was given at inappropriate site; route of administration was subcutaneous; bruising right above the elbow / bruising from the shot is in her elbow; movement of her elbow is affected; This case was reported by a nurse via call center representative and described the occurrence of contusion in a 56-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included Shingrix (received 1st dose on an unknown date).   On 16th April 2021, the patient received the 2nd dose of Shingrix (subcutaneous). In April 2021, 3 days after receiving Shingrix, the patient experienced contusion and mobility decreased. On 16th April 2021, the patient experienced vaccine administered at inappropriate site and intramuscular formulation administered by other route. On an unknown date, the outcome of the contusion, mobility decreased, vaccine administered at inappropriate site and intramuscular formulation administered by other route were not recovered/not resolved.   It was unknown if the reporter considered the contusion and mobility decreased to be related to Shingrix.  Additional details were reported as follows: The age at vaccination was not reported. Reporter was the patient and registered nurse herself. Reporter stated that route of administration was subcutaneous which led to intramuscular formulation administered by other route and was given 7 inches below the deltoid region which led to vaccine administered at inappropriate site. Reporter stated that being a nurse, had administered so many vaccine at her practice. It felt like pharmacist knew what she was doing, but clearly did not. She also stated, that she revisited the pharmacy and asked another pharmacist and he agreed that it was given at inappropriate site. The movement of her elbow was affected and sees bruising right above the elbow. The pharmacy did not provide her lot number, expiration date, or the dosage of the vaccine. She does not have fax number. The reporter consented to follow up.
Age: 0.5
Sex: M
Vaccine: DTAPHEPBIP, HIBV, PNC
Symptoms: Pyrexia, Wrong technique in product usage process
Clinical narrative: low grade fever; Given a dose of Pediarix at the same injection site (limb/muscle) as another vaccine; This case was reported by a pharmacist via call center representative and described the occurrence of low grade fever in a 6-month-old male patient who received DTPa-HBV-IPV (Pediarix) for prophylaxis.   Co-suspect products included dtpa-hbv-ipv vaccine pre-filled syringe device (Pediarix Pre-Filled Syringe Device) injection syringe for prophylaxis, Haemophilus influenzae type b vaccine for prophylaxis and PNEUMOCOCCAL VACCINE (PREVNAR) for prophylaxis.   On 19th April 2021, the patient received the 3rd dose of Pediarix, Pediarix Pre-Filled Syringe Device, Haemophilus influenzae type b vaccine and PREVNAR. On 19th April 2021, less than a day after receiving Pediarix, Pediarix Pre-Filled Syringe Device and Haemophilus influenzae type b vaccine, the patient experienced low grade fever and wrong technique in drug usage process. On an unknown date, the outcome of the low grade fever was not recovered/not resolved and the outcome of the wrong technique in drug usage process was unknown.   It was unknown if the reporter considered the low grade fever to be related to Pediarix, Pediarix Pre-Filled Syringe Device and Haemophilus influenzae type b vaccine. This report is made by GSK without prejudice and does not imply any admission or liability for the incident or its consequences.  Additional details were provided as follows: The case was reported by the patient's mother and pharmacist separately. The patient's mother took the patient for his 3rd dose in the Pediarix series on the day of reporting. The patient also received Prevnar and Haemophilus influenzae type B vaccine (Hib) on the same day.  The Prevnar and Pediarix injections were given in the same injection site, which led to wrong technique in the drug usage process. The package insert stated that when Pediarix is administered concomitantly with other injectable vaccines, they should be given with separate syringes and at different injection sites.  The patient had a low grade fever.  The pharmacist did not have the lot number or expiry date. It was unknown if the reporter considered the low grade fever to be related to Prevnar. The patient's mother gave a consent to contact via electronic communication . The pharmacist also consented to follow-up but declined to provide her address as the administration was given at the doctor's office.
Age: 46.0
Sex: M
Vaccine: DTAPHEPBIP
Symptoms: Underdose, Wrong product administered
Clinical narrative: Adult / patient / administered pediarix instead of an adult dose of engerix b; Adult / patient / administered pediarix instead of an adult dose of engerix b; Adult / patient / administered pediarix instead of an adult dose of engerix b; This case was reported by a other health professional via call center representative and described the occurrence of underdose in a 46-year-old male patient who received DTPa-HBV-IPV (Pediarix) for prophylaxis.   Co-suspect products included dtpa-hbv-ipv vaccine pre-filled syringe device (Pediarix Pre-Filled Syringe Device) injection syringe for prophylaxis.   On 19th April 2021, the patient received Pediarix and Pediarix Pre-Filled Syringe Device. On 19th April 2021, unknown after receiving Pediarix and Pediarix Pre-Filled Syringe Device, the patient experienced underdose, adult use of a child product and wrong vaccine administered. On an unknown date, the outcome of the underdose, adult use of a child product and wrong vaccine administered were unknown.   This report is made by GSK without prejudice and does not imply any admission or liability for the incident or its consequences.  Additional details were provided as follows:  The reporter stated that, an adult male patient was administered pediarix instead of an adult dose of engerix b, which led to underdose, adult use of a child product and wrong vaccine administered. The reporter reported that, they are wondering how to proceed. The reporter consent to follow up.
Age: 68.0
Sex: F
Vaccine: VARZOS
Symptoms: Depression, Diarrhoea, Injection site injury, Injection site nodule, Injection site swelling
Clinical narrative: diarrhea; still achy; felt like ball of smthing in skin; has a hole in her arm / where the shot was given; injection site was swollen / felt like a ball of something was in her skin; injection site was swollen Saturday, extremely hot; could not sleep on right side / was up from 9pm to 6 am Sunday; very edgy and depressed; This case was reported by a consumer via call center representative and described the occurrence of injection site injury in a 68-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   On 27th March 2021, the patient received the 1st dose of Shingrix (intramuscular). On 27th March 2021, less than a day after receiving Shingrix, the patient experienced injection site injury, injection site swelling, injection site warmth, sleep disturbance, tension, pain and swelling. On 28th March 2021 10:00, the patient experienced diarrhea. The patient was treated with benadryl (nos) (Benadryl). On an unknown date, the outcome of the injection site injury, injection site warmth, pain and swelling were not recovered/not resolved and the outcome of the injection site swelling, sleep disturbance and diarrhea were recovered/resolved and the outcome of the tension was unknown.   It was unknown if the reporter considered the injection site injury, injection site swelling, injection site warmth, sleep disturbance, tension, diarrhea, pain and swelling to be related to Shingrix.  Additional details were provided as follow: The case was reported by the patient herself. The patient got her first shingrix shot in her right arm. The patient stated that she still had a hole in her arm where the shot was given. She stated that the injection site was swollen, extremely hot, felt like a ball of something was in her skin, and she could not sleep on right side and was up from 9 pm to 6 am on 28th March 2021. The patient was very edgy and depressed. On 28th March 2021 at 10 am in morning, she had diarrhea, which was very unusual for her, she was still achy.  On 29th March 2021, the patient went to work, took some benadryl and the swelling went down. The reporter consented to follow up. Later, the patient called to provide her healthcare professional's information.
Age: 68.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site warmth, Mood altered, Pain, Sleep disorder, Swelling
Clinical narrative: diarrhea; still achy; felt like ball of smthing in skin; has a hole in her arm / where the shot was given; injection site was swollen / felt like a ball of something was in her skin; injection site was swollen Saturday, extremely hot; could not sleep on right side / was up from 9pm to 6 am Sunday; very edgy and depressed; This case was reported by a consumer via call center representative and described the occurrence of injection site injury in a 68-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   On 27th March 2021, the patient received the 1st dose of Shingrix (intramuscular). On 27th March 2021, less than a day after receiving Shingrix, the patient experienced injection site injury, injection site swelling, injection site warmth, sleep disturbance, tension, pain and swelling. On 28th March 2021 10:00, the patient experienced diarrhea. The patient was treated with benadryl (nos) (Benadryl). On an unknown date, the outcome of the injection site injury, injection site warmth, pain and swelling were not recovered/not resolved and the outcome of the injection site swelling, sleep disturbance and diarrhea were recovered/resolved and the outcome of the tension was unknown.   It was unknown if the reporter considered the injection site injury, injection site swelling, injection site warmth, sleep disturbance, tension, diarrhea, pain and swelling to be related to Shingrix.  Additional details were provided as follow: The case was reported by the patient herself. The patient got her first shingrix shot in her right arm. The patient stated that she still had a hole in her arm where the shot was given. She stated that the injection site was swollen, extremely hot, felt like a ball of something was in her skin, and she could not sleep on right side and was up from 9 pm to 6 am on 28th March 2021. The patient was very edgy and depressed. On 28th March 2021 at 10 am in morning, she had diarrhea, which was very unusual for her, she was still achy.  On 29th March 2021, the patient went to work, took some benadryl and the swelling went down. The reporter consented to follow up. Later, the patient called to provide her healthcare professional's information.
Age: 68.0
Sex: F
Vaccine: VARZOS
Symptoms: Tension
Clinical narrative: diarrhea; still achy; felt like ball of smthing in skin; has a hole in her arm / where the shot was given; injection site was swollen / felt like a ball of something was in her skin; injection site was swollen Saturday, extremely hot; could not sleep on right side / was up from 9pm to 6 am Sunday; very edgy and depressed; This case was reported by a consumer via call center representative and described the occurrence of injection site injury in a 68-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   On 27th March 2021, the patient received the 1st dose of Shingrix (intramuscular). On 27th March 2021, less than a day after receiving Shingrix, the patient experienced injection site injury, injection site swelling, injection site warmth, sleep disturbance, tension, pain and swelling. On 28th March 2021 10:00, the patient experienced diarrhea. The patient was treated with benadryl (nos) (Benadryl). On an unknown date, the outcome of the injection site injury, injection site warmth, pain and swelling were not recovered/not resolved and the outcome of the injection site swelling, sleep disturbance and diarrhea were recovered/resolved and the outcome of the tension was unknown.   It was unknown if the reporter considered the injection site injury, injection site swelling, injection site warmth, sleep disturbance, tension, diarrhea, pain and swelling to be related to Shingrix.  Additional details were provided as follow: The case was reported by the patient herself. The patient got her first shingrix shot in her right arm. The patient stated that she still had a hole in her arm where the shot was given. She stated that the injection site was swollen, extremely hot, felt like a ball of something was in her skin, and she could not sleep on right side and was up from 9 pm to 6 am on 28th March 2021. The patient was very edgy and depressed. On 28th March 2021 at 10 am in morning, she had diarrhea, which was very unusual for her, she was still achy.  On 29th March 2021, the patient went to work, took some benadryl and the swelling went down. The reporter consented to follow up. Later, the patient called to provide her healthcare professional's information.
Sex: F
Vaccine: HEP
Symptoms: Expired product administered
Clinical narrative: administering expired pediatric dose of Engerix-B on 4/19/2021 / vaccine was expired on 02/27/2021; This case was reported by a nurse via call center representative and described the occurrence of expired vaccine used in a female patient who received HBV (Engerix B) (batch number 97LJ2, expiry date 27th February 2021) for prophylaxis.   Co-suspect products included hepatitis B vaccine pre-filled syringe device (Engerix B Pre-Filled Syringe Device) injection syringe for prophylaxis.   On 19th April 2021, the patient received Engerix B and Engerix B Pre-Filled Syringe Device. On 19th April 2021, unknown after receiving Engerix B and Engerix B Pre-Filled Syringe Device, the patient experienced expired vaccine used. On an unknown date, the outcome of the expired vaccine used was unknown.     This report is made by GSK without prejudice and does not imply any admission or liability for the incident or its consequences.  Additional information provided were as follows: The age at vaccination was not reported. The patient was administered an expired pediatric dose of Engerix B. The reporter asked for how long it was good for after expiration. No other details given. The reporter consented to follow-up
Sex: U
Vaccine: HEP
Symptoms: Incomplete course of vaccination
Clinical narrative: a large cohort of staff are overdue for Engerix-B; This case was reported by a other health professional via call center representative and described the occurrence of incomplete course of vaccination in an unspecified number of patients who received HBV (Engerix B) for prophylaxis.   On an unknown date, the patient received Engerix B. On an unknown date, unknown after receiving Engerix B, the patient experienced incomplete course of vaccination. On an unknown date, the outcome of the incomplete course of vaccination was unknown.  Additional details were reported as follows: The age at vaccination was not applicable for this report. The healthcare professional was Pharmacy Procurement Lead, reports large cohort of staff was overdue for Engerix-B, which led to incomplete course of vaccination. No patient demographics, lot numbers or expiration dates provided. No additional information provided. The reporter did not consented to follow up.
Age: 50.0
Sex: F
Vaccine: VARZOS
Symptoms: Blister, Herpes zoster
Clinical narrative: blisters on/ lower right mid section / mid section of her back/ diagnosed the blisters as shingles; blisters on/ lower right mid section / mid section of her back/ diagnosed the blisters as shingles; This case was reported by a consumer via call center representative and described the occurrence of shingles in a 50-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   On 28th December 2020, the patient received the 1st dose of Shingrix (intramuscular). On 31st December 2020, 3 days after receiving Shingrix, the patient experienced shingles and blister. On an unknown date, the outcome of the shingles and blister were unknown.   It was unknown if the reporter considered the shingles and blister to be related to Shingrix.  Additional details were reported as follows: The case was reported by patient herself. The patient had her first and only Shingrix vaccine in left arm and she noticed blisters on the lower right mid section. These blisters continued to spread around to the mid section of her back. The patient's physician diagnosed the blisters as shingles. The reporter consented to follow up. Note : Since patient received vaccine on 28th December 2020 and event onset date was reported as 31st December 2021, which is futuristic date(Typo) hence event onset date was captured as 31st December 2020.
Sex: F
Vaccine: VARZOS
Symptoms: Incomplete course of vaccination
Clinical narrative: only received one dose of Shingrix on Sep 15th 2019.; This case was reported by a pharmacist via call center representative and described the occurrence of incomplete course of vaccination in a 66-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included shingrix (1st dose received on 15th September 2019).   On an unknown date, the patient received the 2nd dose of Shingrix. On an unknown date, unknown after receiving Shingrix, the patient experienced incomplete course of vaccination. On an unknown date, the outcome of the incomplete course of vaccination was unknown.  Additional details were provided as follows: The age at vaccination was not applicable for this report. The reporter was looking for some guidance because, the patient was not immunocompromised who only received one dose of Shingrix, till the time of reporting patient did not receive 2nd dose, which led to incomplete course of vaccination. The reporter consented to follow-up.