chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 77.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Asthenia, Chronic obstructive pulmonary disease, Condition aggravated, Death, Gait inability
Clinical narrative: Weakness, no longer able to walk, needed wheelchair, COPD became more severe after receiving injections, overall condition rapidly deteriorated.  Had been stable on 4 lpm of Oxygen prior to vaccines.     Always had negative COVid tests and no Covid symptoms.
Age: 77.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: General physical health deterioration, Laboratory test abnormal, Lung neoplasm malignant, SARS-CoV-2 test negative, Wheelchair user
Clinical narrative: Weakness, no longer able to walk, needed wheelchair, COPD became more severe after receiving injections, overall condition rapidly deteriorated.  Had been stable on 4 lpm of Oxygen prior to vaccines.     Always had negative COVid tests and no Covid symptoms.
Age: 25.0
Sex: M
Vaccine: COVID19
Symptoms: Product storage error
Clinical narrative: the vaccine may have stored under conditions that departed from the manufacturer's recommended specifications.
Age: 70.0
Sex: F
Vaccine: COVID19, COVID19, COVID19, COVID19
Symptoms: Ataxia, Balance disorder, Blindness, Cognitive disorder, Communication disorder
Clinical narrative: Patient complained of numbness and pain at injection site.  These symptoms began within hours of receiving vaccine.  The pain was described as "immense pressure, injection area tightness and a burning sensation".  Over the course of the following weeks until death patient suffered from numbness that traveled from injection site through left side of body and became fixed.  Chronic fatigue, Loss of balance, Left side hearing loss,  Double vision/blindness, Dementia, Rigid Limbs,  Graphic Tremors in limbs and chest,  Lost ability to communicate due to muscle rigidity and loss of muscle control, loss of mobility, Suffered from delusions and hallucinations.  Acute degrade of cognition until Death.
Age: 70.0
Sex: F
Vaccine: COVID19, COVID19, COVID19, COVID19
Symptoms: Deafness unilateral, Death, Delusion, Dementia, Diplopia
Clinical narrative: Patient complained of numbness and pain at injection site.  These symptoms began within hours of receiving vaccine.  The pain was described as "immense pressure, injection area tightness and a burning sensation".  Over the course of the following weeks until death patient suffered from numbness that traveled from injection site through left side of body and became fixed.  Chronic fatigue, Loss of balance, Left side hearing loss,  Double vision/blindness, Dementia, Rigid Limbs,  Graphic Tremors in limbs and chest,  Lost ability to communicate due to muscle rigidity and loss of muscle control, loss of mobility, Suffered from delusions and hallucinations.  Acute degrade of cognition until Death.
Age: 70.0
Sex: F
Vaccine: COVID19, COVID19, COVID19, COVID19
Symptoms: Fatigue, Hallucination, Hypoaesthesia, Injection site discomfort, Injection site hypoaesthesia
Clinical narrative: Patient complained of numbness and pain at injection site.  These symptoms began within hours of receiving vaccine.  The pain was described as "immense pressure, injection area tightness and a burning sensation".  Over the course of the following weeks until death patient suffered from numbness that traveled from injection site through left side of body and became fixed.  Chronic fatigue, Loss of balance, Left side hearing loss,  Double vision/blindness, Dementia, Rigid Limbs,  Graphic Tremors in limbs and chest,  Lost ability to communicate due to muscle rigidity and loss of muscle control, loss of mobility, Suffered from delusions and hallucinations.  Acute degrade of cognition until Death.
Age: 70.0
Sex: F
Vaccine: COVID19, COVID19, COVID19, COVID19
Symptoms: Injection site pain, Injection site reaction, Laboratory test, Mobility decreased, Muscle rigidity
Clinical narrative: Patient complained of numbness and pain at injection site.  These symptoms began within hours of receiving vaccine.  The pain was described as "immense pressure, injection area tightness and a burning sensation".  Over the course of the following weeks until death patient suffered from numbness that traveled from injection site through left side of body and became fixed.  Chronic fatigue, Loss of balance, Left side hearing loss,  Double vision/blindness, Dementia, Rigid Limbs,  Graphic Tremors in limbs and chest,  Lost ability to communicate due to muscle rigidity and loss of muscle control, loss of mobility, Suffered from delusions and hallucinations.  Acute degrade of cognition until Death.
Age: 70.0
Sex: F
Vaccine: COVID19, COVID19, COVID19, COVID19
Symptoms: Skin tightness, Tremor
Clinical narrative: Patient complained of numbness and pain at injection site.  These symptoms began within hours of receiving vaccine.  The pain was described as "immense pressure, injection area tightness and a burning sensation".  Over the course of the following weeks until death patient suffered from numbness that traveled from injection site through left side of body and became fixed.  Chronic fatigue, Loss of balance, Left side hearing loss,  Double vision/blindness, Dementia, Rigid Limbs,  Graphic Tremors in limbs and chest,  Lost ability to communicate due to muscle rigidity and loss of muscle control, loss of mobility, Suffered from delusions and hallucinations.  Acute degrade of cognition until Death.
Age: 16.0
Sex: M
Vaccine: COVID19
Symptoms: Product storage error
Clinical narrative: the vaccine the patient received may have been stored under conditions that departed from the manufacturer's recommended specifications.
Age: 44.0
Sex: F
Vaccine: COVID19
Symptoms: Eye disorder, Photopsia
Clinical narrative: My left eye started experiencing a dull throbbing and then a white light moving up and down in my periphery vision. This is still occurring since December. I spoke with my ophthalmologist, and she also had the same side effects from the Pfizer vaccine, impacting the eye on the same side as where she received her vaccine also.
Age: 49.0
Sex: F
Vaccine: COVID19
Symptoms: Injection site pain, Injection site reaction, Rash erythematous
Clinical narrative: Quarter size red rash at injection sight. Painful to the touch.
Age: 23.0
Sex: M
Vaccine: COVID19
Symptoms: Product storage error
Clinical narrative: The vaccine the patient received may have been stored under conditions that departed from manufacturer's recommended specifications.
Age: 59.0
Sex: M
Vaccine: COVID19
Symptoms: Tinnitus
Clinical narrative: tinitus
Age: 22.0
Sex: F
Vaccine: COVID19
Symptoms: Product storage error
Clinical narrative: The vaccine the patient received may have been stored under conditions that departed from the manufacturer's specifications,
Age: 16.0
Sex: F
Vaccine: COVID19
Symptoms: Product storage error
Clinical narrative: The vaccine the patient received may have been stored under conditions that departed from the manufacturer's  recommended specifications.
Age: 37.0
Sex: F
Vaccine: COVID19
Symptoms: Dizziness, Headache
Clinical narrative: Patient reported having a headache after dose 2 that was relieved with ibuprofen and sleep at the nurses advise. Patient was counseled the same could happen with her booster (dose 3). Patient reported headache after about 10 minutes of receiving dose. Patient was advised to stay and given water. Patient took ibuprofen to help with headache. Patient got dizzy. Patient was checked on  and refused us to call 911. Patient called for a ride and did not check in with pharmacy before leaving.
Age: 19.0
Sex: F
Vaccine: COVID19
Symptoms: Expired product administered, No adverse event
Clinical narrative: Patient had received an expired vaccine that was reported by Pfizer by a labeling error. no adverse reactions when speaking to the patient and they will come back for the second dose with a current vaccine
Age: 15.0
Sex: F
Vaccine: COVID19
Symptoms: Product storage error
Clinical narrative: The vaccine the patient received may have been stored under conditions that departed from the manufacturer's recommended specifications.
Age: 37.0
Sex: M
Vaccine: COVID19
Symptoms: Expired product administered, No adverse event
Clinical narrative: Patient received an expired dose but showed no adverse reactions
Age: 66.0
Sex: F
Vaccine: FLU4, UNK
Symptoms: Asthenia, Dizziness, Feeding disorder, Nausea
Clinical narrative: The afternoon after the vaccine I felt real weak, dizzy and so nauseous.  This morning and all day it has gotten worse. Can't eat anything. Juat a lingering nausea
Age: 21.0
Sex: M
Vaccine: COVID19
Symptoms: Product storage error
Clinical narrative: The vaccine the patient received may have been stored under conditions that departed from the manufacturer's recommended specifications.
Age: 46.0
Sex: F
Vaccine: COVID19
Symptoms: Expired product administered, No adverse event
Clinical narrative: patient recieved an expired vaccine error due to pfizer labeling. patient reports no adverse reactions yet.
Age: 27.0
Sex: M
Vaccine: COVID19
Symptoms: Chest X-ray, Chest discomfort, Dyspnoea, Electrocardiogram, Palpitations
Clinical narrative: Shortness of breath; chest tightness, chest palpitations
Age: 71.0
Sex: M
Vaccine: COVID19
Symptoms: Catheterisation cardiac, Dyspnoea, Fatigue
Clinical narrative: Fatigue, short of breath
Age: 16.0
Sex: M
Vaccine: COVID19
Symptoms: Product storage error
Clinical narrative: The vaccine the patient received may have stored under conditions that departed from the manufacturer's recommended specifications.
Age: 58.0
Sex: F
Vaccine: COVID19, COVID19, COVID19
Symptoms: Areflexia, Ataxia, CSF protein increased, CSF red blood cell count, Herpes zoster
Clinical narrative: shingles lower back - 12/11 Muscle soreness, 1/3 Lower extremity myopathy, 1/8 ataxic gait/wheelchair, areflexia ongoing to date
Age: 58.0
Sex: F
Vaccine: COVID19, COVID19, COVID19
Symptoms: Lumbar puncture, Myalgia, Myopathy, Protein total, Red blood cell count
Clinical narrative: shingles lower back - 12/11 Muscle soreness, 1/3 Lower extremity myopathy, 1/8 ataxic gait/wheelchair, areflexia ongoing to date
Age: 58.0
Sex: F
Vaccine: COVID19, COVID19, COVID19
Symptoms: Wheelchair user
Clinical narrative: shingles lower back - 12/11 Muscle soreness, 1/3 Lower extremity myopathy, 1/8 ataxic gait/wheelchair, areflexia ongoing to date
Age: 14.0
Sex: F
Vaccine: COVID19
Symptoms: Product storage error
Clinical narrative: The vaccine the patient received may have been stored under conditions that departed from the manufacturer's recommended specifications.
Age: 68.0
Sex: F
Vaccine: COVID19
Symptoms: Acoustic stimulation tests abnormal, Hyperacusis, Hypoacusis, Tinnitus
Clinical narrative: Right ear:  Extremely loud high pitch frequency sound and wind sound with partial hearing loss
Age: 44.0
Sex: M
Vaccine: COVID19
Symptoms: Product storage error
Clinical narrative: The vaccine the patient received may have been stored under conditions that departed from the manufacturer's recommended specifications.
Age: 37.0
Sex: F
Vaccine: COVID19
Symptoms: Acupuncture, Balance disorder, Blood test, Computerised tomogram, Dizziness
Clinical narrative: On 1/28/22, I woke up in the middle of the night to intense vertigo. Shortly after I developed tinnitus to my right ear, ear pressure and muffled hearing. I have gone to ER and had CT scan done and blood work. I have seen an ENT and neurologist and had MRI done of the brain which also came back normal. I have been on 2 courses of antibiotics and steroid therapy with no relief. I am now getting acupuncture and vestibular therapy. I have been on medical leave and had to apply for disability due to having loss of balance and constantly feeling dizzy.
Age: 37.0
Sex: F
Vaccine: COVID19
Symptoms: Ear discomfort, Ear, nose and throat examination, Hypoacusis, Magnetic resonance imaging head normal, Tinnitus
Clinical narrative: On 1/28/22, I woke up in the middle of the night to intense vertigo. Shortly after I developed tinnitus to my right ear, ear pressure and muffled hearing. I have gone to ER and had CT scan done and blood work. I have seen an ENT and neurologist and had MRI done of the brain which also came back normal. I have been on 2 courses of antibiotics and steroid therapy with no relief. I am now getting acupuncture and vestibular therapy. I have been on medical leave and had to apply for disability due to having loss of balance and constantly feeling dizzy.
Age: 37.0
Sex: F
Vaccine: COVID19
Symptoms: Vertigo
Clinical narrative: On 1/28/22, I woke up in the middle of the night to intense vertigo. Shortly after I developed tinnitus to my right ear, ear pressure and muffled hearing. I have gone to ER and had CT scan done and blood work. I have seen an ENT and neurologist and had MRI done of the brain which also came back normal. I have been on 2 courses of antibiotics and steroid therapy with no relief. I am now getting acupuncture and vestibular therapy. I have been on medical leave and had to apply for disability due to having loss of balance and constantly feeling dizzy.
Age: 39.0
Sex: M
Vaccine: COVID19
Symptoms: Atrioventricular block, Impaired work ability
Clinical narrative: On 09/06/2021 I received Janssen single shot Covid- 19 vaccine in camp. The doctor who treated me at Hospital and the doctor I have consulted, commented the same that the side effects of the vaccine might be the cause for the sudden development of block in my heart. And there were no health issues found for me in the last medical checkup done for me in November 2020.Here I am assuring you I can deliver the best of me in work like I was doing before.
Age: 40.0
Sex: F
Vaccine: MMRV
Symptoms: No adverse event, Wrong product administered
Clinical narrative: No adverse reaction @ time of administrating vx. Pt was administered wrong supply of vaccine. Was administered proquad which is not recommended for pt's age.
Age: 76.0
Sex: M
Vaccine: COVID19
Symptoms: Blood immunoglobulin E normal, Blood pressure increased, Body temperature increased, Chills, Death
Clinical narrative: Awoke at approximately 1230 hours on 12/30/2021 with chills, elevated blood pressure, and temperature of 101F. Took Tylenol and nitroglycerin. Had seizure-like activity then went unresponsive. CPR attempted to no avail. Death pronounced at 0424 hours on 12/30/2021.
Age: 76.0
Sex: M
Vaccine: COVID19
Symptoms: Resuscitation, Seizure like phenomena, Tryptase, Unresponsive to stimuli
Clinical narrative: Awoke at approximately 1230 hours on 12/30/2021 with chills, elevated blood pressure, and temperature of 101F. Took Tylenol and nitroglycerin. Had seizure-like activity then went unresponsive. CPR attempted to no avail. Death pronounced at 0424 hours on 12/30/2021.
Age: 20.0
Sex: F
Vaccine: FLU4, HPV9, MENB, VARCEL
Symptoms: Bell's palsy, Facial paresis, Hypoaesthesia
Clinical narrative: Right facial weakness/numbness on day of vaccine treated for Bells Palsy
Age: 76.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Fatigue, Incontinence, Palpitations
Clinical narrative: Started 4 days after #2 she  has had incontinent fatigue and palpitations
Age: 63.0
Sex: F
Vaccine: COVID19
Symptoms: Fatigue, Injection site pain
Clinical narrative: Injection site soreness x3 days, fatigue x2 days
Age: 35.0
Sex: F
Vaccine: COVID19
Symptoms: Arthralgia, Chills, Fatigue, Headache, Myalgia
Clinical narrative: Headache, Myalgia, Arthralgia, chills, fatigue Narrative:
Age: 60.0
Sex: F
Vaccine: COVID19
Symptoms: Arthralgia, Headache, Myalgia, Oropharyngeal pain, Pain
Clinical narrative: Narrative: Headache, Myalgia, Arthralgia & Fever sore throat, fever, body aches, and  headache
Age: 60.0
Sex: F
Vaccine: COVID19
Symptoms: Pyrexia
Clinical narrative: Narrative: Headache, Myalgia, Arthralgia & Fever sore throat, fever, body aches, and  headache
Age: 63.0
Sex: F
Vaccine: COVID19
Symptoms: Fatigue, Feeling abnormal, Lymphadenopathy, Pain
Clinical narrative: soreness, fatigue, foggy, swollen lymph nodes in armpit Narrative:
Age: 58.0
Sex: F
Vaccine: COVID19
Symptoms: Fatigue, Headache, Hot flush, Pain, Tenderness
Clinical narrative: Narrative: Headache ARM SORE TO TOUCH OR MOVE, HOT FLASHES, FATIGUE
Age: 38.0
Sex: F
Vaccine: COVID19
Symptoms: Dizziness, Myalgia
Clinical narrative: Dizziness & Myalgia  Narrative:
Age: 43.0
Sex: M
Vaccine: COVID19
Symptoms: Headache, Injection site swelling, Myalgia
Clinical narrative: Headache, Myalgia, swelling to injection site  Narrative:
Age: 69.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Asthenia, Gait disturbance, Loss of personal independence in daily activities, Mobility decreased, Pain in extremity
Clinical narrative: I took the 1st injection on 2/6/21..pretty much okay in a couple of weeks 2nd injection on 3/6/21...site never healed..pain stayed and months following the use of arm and body weaken. I stopped walking on daily walks...upper back and body..pressure. Nothing is done on left arm because of previous breast cancer. Just concerned how I can get any type of injection into arm now. Dr. gave e a steroid injectionsback of right shoulder 3 wks ago..still painful.
Age: 69.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: X-ray limb normal
Clinical narrative: I took the 1st injection on 2/6/21..pretty much okay in a couple of weeks 2nd injection on 3/6/21...site never healed..pain stayed and months following the use of arm and body weaken. I stopped walking on daily walks...upper back and body..pressure. Nothing is done on left arm because of previous breast cancer. Just concerned how I can get any type of injection into arm now. Dr. gave e a steroid injectionsback of right shoulder 3 wks ago..still painful.
Age: 53.0
Sex: M
Vaccine: COVID19
Symptoms: Arthralgia, Chest discomfort, Chest pain, Fatigue, Myalgia
Clinical narrative: Leg pain currently; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient. Other Case identifier(s): US-PFIZER INC-202101466775.  A 53 year-old male patient received bnt162b2 (BNT162B2), intramuscular, administered in arm right, administration date 06Oct2021 16:00 (Lot number: FC3182) at the age of 53 years as dose 2, single for covid-19 immunisation. The patient had no relevant medical history. The patient's concomitant medications were not reported. Vaccination history included: Bnt162b2 (Dose 1, single, Date/Time: 15Sep2021/ 16:00 , Anatomical site of administration: Right shoulder, Route of administration: Intramuscular, Batch/Lot number: FD8448), administration date: 15Sep2021, when the patient was 53 years old, for COVID-19 immunisation, reaction(s): "Fatigue", "Joint pain", "Muscle pain", "Chest pain/tightness", "leg pain currently", "Some chest pain/tightness.".  The following information was reported: PAIN IN EXTREMITY (non-serious) with onset 2021, outcome "unknown", described as "Leg pain currently".  Additional information: Anatomical site of administration: Right shoulder  No follow-up attempts are possible. No further information is expected.
Age: 53.0
Sex: M
Vaccine: COVID19
Symptoms: Pain in extremity
Clinical narrative: Leg pain currently; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient. Other Case identifier(s): US-PFIZER INC-202101466775.  A 53 year-old male patient received bnt162b2 (BNT162B2), intramuscular, administered in arm right, administration date 06Oct2021 16:00 (Lot number: FC3182) at the age of 53 years as dose 2, single for covid-19 immunisation. The patient had no relevant medical history. The patient's concomitant medications were not reported. Vaccination history included: Bnt162b2 (Dose 1, single, Date/Time: 15Sep2021/ 16:00 , Anatomical site of administration: Right shoulder, Route of administration: Intramuscular, Batch/Lot number: FD8448), administration date: 15Sep2021, when the patient was 53 years old, for COVID-19 immunisation, reaction(s): "Fatigue", "Joint pain", "Muscle pain", "Chest pain/tightness", "leg pain currently", "Some chest pain/tightness.".  The following information was reported: PAIN IN EXTREMITY (non-serious) with onset 2021, outcome "unknown", described as "Leg pain currently".  Additional information: Anatomical site of administration: Right shoulder  No follow-up attempts are possible. No further information is expected.
Age: 5.0
Sex: M
Vaccine: DTAP
Symptoms: Seizure, Vomiting
Clinical narrative: had an attack, vomiting, convulsions.
Age: 54.0
Sex: U
Vaccine: COVID19
Symptoms: Unevaluable event
Clinical narrative: None Stated
Age: 16.0
Sex: F
Vaccine: COVID19
Symptoms: Reaction to previous exposure to any vaccine
Clinical narrative: none
Age: 25.0
Sex: M
Vaccine: COVID19
Symptoms: Unevaluable event
Clinical narrative: none
Age: 73.0
Sex: F
Vaccine: COVID19
Symptoms: Unevaluable event
Clinical narrative: none
Sex: M
Vaccine: COVID19
Symptoms: Unevaluable event
Clinical narrative: none
Age: 62.0
Sex: F
Vaccine: COVID19
Symptoms: Acoustic stimulation tests, Ear, nose and throat examination, Tinnitus, Vertigo
Clinical narrative: Tinnitus; Vertigo; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP) for a Pfizer sponsored program. The reporter is the patient.  A 62 year-old female patient received bnt162b2 (BNT162B2), administered in deltoid right, administration date 19Jan2021 08:15 (Lot number: EL1284) at the age of 62 years as dose 2, single for covid-19 immunisation. Relevant medical history included: "Thyroid-Hypo", start date: 1995 (unspecified if ongoing). Concomitant medication(s) included: TYLENOL, start date: 19Jan2021. Vaccination history included: Bnt162b2 (DOSE 1,SINGLE, Vaccine name: Pfizer -Bio, Lot number: EH9899, Route: IM, Anatomical Location: L-Deltoid), administration date: 29Dec2020, when the patient was 62 years old, for Covid-19 Immunization. The following information was reported: TINNITUS (non-serious) with onset 20Jan2021 04:30, outcome "not recovered", described as "Tinnitus"; VERTIGO (non-serious) with onset 20Jan2021 04:30, outcome "unknown", described as "Vertigo". The events "tinnitus" and "vertigo" were evaluated at the physician office visit. Relevant laboratory tests and procedures are available in the appropriate section. Therapeutic measures were taken as a result of tinnitus. No follow-up attempts are possible. No further information is expected.
Age: 86.0
Sex: M
Vaccine: COVID19
Symptoms: Injection, Joint range of motion decreased, Muscular weakness, Pain in extremity, Rash
Clinical narrative: This is a follow up from VEARS number 1095518. The next day after receiving my vaccine, I experienced a complete body rash with itching. I went to the hospital and received 21 days of Prednisone. I went back to the hospital on 22nd day and received 30 days of Prednisone and some shots. The rash subsided. To this day about a year later, the rash will still appear on my arms and chest. I went to an orthopedic doctor and I had a series of shots due to arm weakness which included a cortisone shot. A few months later I received another round of cortisone shots, then 3 months later more cortisone shots. After 3 rounds, he wants to run more tests including an MRI which is going to be scheduled. I have issues with arm weakness and pain, that affects my range of motion . I have also been going to a chiropractor to help with the arm pain and weakness.
Age: 86.0
Sex: M
Vaccine: COVID19
Symptoms: Rash pruritic
Clinical narrative: This is a follow up from VEARS number 1095518. The next day after receiving my vaccine, I experienced a complete body rash with itching. I went to the hospital and received 21 days of Prednisone. I went back to the hospital on 22nd day and received 30 days of Prednisone and some shots. The rash subsided. To this day about a year later, the rash will still appear on my arms and chest. I went to an orthopedic doctor and I had a series of shots due to arm weakness which included a cortisone shot. A few months later I received another round of cortisone shots, then 3 months later more cortisone shots. After 3 rounds, he wants to run more tests including an MRI which is going to be scheduled. I have issues with arm weakness and pain, that affects my range of motion . I have also been going to a chiropractor to help with the arm pain and weakness.
Age: 19.0
Sex: F
Vaccine: COVID19
Symptoms: Fatigue, Pain in extremity, SARS-CoV-2 test negative
Clinical narrative: fatigue; sore arm; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 20 year-old female patient received bnt162b2 (BNT162B2), intramuscular, administered in arm right, administration date 01Apr2021 17:05 (Lot number: ER8727) at the age of 19 years as dose 1, single for covid-19 immunisation. Relevant medical history included: "Birth control" (unspecified if ongoing). Concomitant medication(s) included: SEASONIQUE taken for contraception, start date: 2016 (ongoing); AMETHIA taken for contraception, start date: 2016 (ongoing). The following information was reported: FATIGUE (non-serious), outcome "unknown", described as "fatigue"; PAIN IN EXTREMITY (non-serious), outcome "unknown", described as "sore arm". Relevant laboratory tests and procedures are available in the appropriate section. The patient received her first vaccine on 01Apr2021 and had fatigue and sore arm only. The patient then received her second vaccine on 22Apr2021. Within 45 minutes receiving the vaccine the paient developed facial swelling, Fever, Rash and tachy cardia. The patient was instructed to go to the ER by her clinic nurse. The patient was given steroids, benadryl and pepcid in the ER and then sent home with 5 days of steroids, benadryl and pepcid and told to follow up with her PCP. The patient Followed UP on April 27th with her PCP and was still having Facial swelling and rash and was given 7 more days of steroids. On 11Jul2021, the patient then developed pityriasis rosea that lasted 5 weeks. The patient did not had any illnesses prior to the rash so it was believed to be related to her covid vaccine reaction given that it was an autoimmune rash. Since then the patient developed a daily rash especially when she in any kind of warm climate -on  13Sep2021. The patient again developed facial Swelling with a rash and seen by my PCP and was prescribed steroids, benadryl and Pepcid. The patient was also referred to an allergist and seen by an allergist on 04Oct2021, at that time the patient underwent allergy testing and had an extensive reaction and. was given, medication while in the office. The patient now takin's 4 zyrtec a day and was given a tri-pen and never had any factions to environmental allergens until her vaccine Reaction. The patient also continue to get daily rashes with showering, exercise of any time the patient get to warn ALL of this was new since her vaccine reaction. The patient was an active soccer Player all the rash high school and never broke at into a rash and also was able to shower without breaking at the in a rash. If needed the patient had picture documentation of all of this. The patient currently under Joins on autoimmune workup because her PCP was concerned her vaccine reaction had set off an auto immune disorder.  No follow-up attempts are possible. No further information is expected.
Age: 51.0
Sex: U
Vaccine: COVID19
Symptoms: Acoustic stimulation tests, Eye pain, Fatigue, Headache, Tinnitus
Clinical narrative: fatigue; worst headache of my life; eye sockets hurting; Ringing increased and prompted me to go to the ENT; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 51 year-old patient received bnt162b2 (BNT162B2), administered in arm left, administration date 05May2021 10:00 (Lot number: EW0173) at the age of 51 years as dose 2, single for covid-19 immunisation. Relevant medical history included: "Type 1 Diabetic" (unspecified if ongoing). Concomitant medication(s) included: HUMALOG. Vaccination history included: Bnt162b2 (Dose Number: 1, Batch/Lot No: ER8737, Location of injection: Arm Left, Vaccine Administration Time: 10:00 AM), administration date: 07Apr2021, when the patient was 51 years old, for COVID-19 immunization, reaction(s): "felt extreme burning go up my arm and into my face and chest", "Approximately 3-5 days after I began to have a high pitch ringing in my left ear". The following information was reported: FATIGUE (non-serious) with onset May2021, outcome "not recovered", described as "fatigue"; HEADACHE (non-serious) with onset May2021, outcome "not recovered", described as "worst headache of my life"; EYE PAIN (non-serious) with onset May2021, outcome "not recovered", described as "eye sockets hurting"; TINNITUS (non-serious) with onset May2021, outcome "not recovered", described as "Ringing increased and prompted me to go to the ENT". The events "fatigue", "worst headache of my life", "eye sockets hurting" and "ringing increased and prompted me to go to the ent" were evaluated at the physician office visit. Relevant laboratory tests and procedures are available in the appropriate section. Therapeutic measures were not taken as a result of fatigue, headache, eye pain, tinnitus.  Additional information: Patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Prior to vaccination, the patient was not diagnosed with COVID-19 and since vaccination, the patient has not been tested for COVID-19. Clinical course: It was reported that after second injection patient had the worst headache of life with eye sockets hurting and fatigue. Ringing increased and prompted patient to go to the ENT. Went to an ENT after second injection and hearing test was within normal range. Patients want to take a booster but afraid and will get it in other ear. Patient wants to know is there any chance dosage is too strong for some people. Is there any research that can be done to help. Patient was afraid.  No follow-up attempts are possible. No further information is expected.
Age: 47.0
Sex: F
Vaccine: COVID19
Symptoms: Feeling hot, Pruritus
Clinical narrative: ITCHING; FEELING HOT; This spontaneous report received from a patient via a company representative concerned a 47 or 48 years (5 decade) old female. The patient's height, and weight were not reported. The patient's concurrent conditions included: relapsing-remitting multiple sclerosis, PCOS (Polycystic ovarian syndrome), asthma, hypothyroidism, seasonal allergy, Tysabri allergy, and shrimp allergy anaphylaxis. The patient received covid-19 vaccine ad26.cov2.s (Dose number in series 1) (suspension for injection, route of admin, and batch number were not reported) dose was not reported, 1 total, administered on JUN-2021 for prophylactic vaccination. The batch number was not reported. The Company is unable to perform follow-up to request batch/lot numbers. Concomitant medications included budesonide/formoterol fumarate, epinephrine, ocrelizumab, and salbutamol.  On an unspecified date, the patient experienced itching, and feeling hot (Dose number in series 1). The patient received Moderna vaccine (mrna 1273) (Dose number in series 2) (form of admin, route of admin and batch number were not reported) dose was not reported, administered on an unspecified date for prophylactic vaccination. No adverse events reported post booster vaccination (Dose number in series 2). The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the itching and feeling hot was not reported. This report was non-serious.
Age: 65.0
Sex: U
Vaccine: COVID19, COVID19
Symptoms: Alopecia, SARS-CoV-2 test, Urticaria
Clinical narrative: throat was closing; couldn't swallow; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 65 year-old patient received bnt162b2 (BNT162B2), intramuscular, administered in arm right, administration date 08Mar2021 (Lot number: EN6199) at the age of 65 years as dose 1, single for covid-19 immunisation. Relevant medical history included: "Lyme disease", start date: 1956 (ongoing), notes: I had a questions for an antibiotic for Lyme disease once from 1956 to date that is it.; "Shingles once" (unspecified if ongoing). The patient's concomitant medications were not reported. The following information was reported: THROAT TIGHTNESS (non-serious), outcome "unknown", described as "throat was closing"; DYSPHAGIA (non-serious), outcome "unknown", described as "couldn't swallow". Relevant laboratory tests and procedures are available in the appropriate section.  Additional information: Patient felt like throat was closing pulled over onside the road. Patient was driving could not swallow that was after watching 15 min in the Pharmacy. Patient received vaccine in the noon. Vaccination facility type was pharmacy or drug store. Patient not administered other vaccine in four weeks. Family medical history relevant to AE(s) was none. Specific Relevant Test for Thromboembolic events with Thrombocytopenia was none. The patient underwent the following laboratory tests and procedures: chest x-ray: no pneumonia; sars-cov-2 test negative: negative; sars-cov-2 test positive: positive.  Follow-up attempts are completed. No further information is expected.
Age: 65.0
Sex: U
Vaccine: COVID19, COVID19
Symptoms: Chest X-ray, Dysphagia, SARS-CoV-2 test negative, SARS-CoV-2 test positive, Throat tightness
Clinical narrative: throat was closing; couldn't swallow; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 65 year-old patient received bnt162b2 (BNT162B2), intramuscular, administered in arm right, administration date 08Mar2021 (Lot number: EN6199) at the age of 65 years as dose 1, single for covid-19 immunisation. Relevant medical history included: "Lyme disease", start date: 1956 (ongoing), notes: I had a questions for an antibiotic for Lyme disease once from 1956 to date that is it.; "Shingles once" (unspecified if ongoing). The patient's concomitant medications were not reported. The following information was reported: THROAT TIGHTNESS (non-serious), outcome "unknown", described as "throat was closing"; DYSPHAGIA (non-serious), outcome "unknown", described as "couldn't swallow". Relevant laboratory tests and procedures are available in the appropriate section.  Additional information: Patient felt like throat was closing pulled over onside the road. Patient was driving could not swallow that was after watching 15 min in the Pharmacy. Patient received vaccine in the noon. Vaccination facility type was pharmacy or drug store. Patient not administered other vaccine in four weeks. Family medical history relevant to AE(s) was none. Specific Relevant Test for Thromboembolic events with Thrombocytopenia was none. The patient underwent the following laboratory tests and procedures: chest x-ray: no pneumonia; sars-cov-2 test negative: negative; sars-cov-2 test positive: positive.  Follow-up attempts are completed. No further information is expected.
Sex: U
Vaccine: COVID19
Symptoms: Adverse reaction, Splenic vein thrombosis, Thrombosis with thrombocytopenia syndrome
Clinical narrative: This spontaneous report received from a patient via a company representative from social media concerned a patient of unspecified age, sex, race and ethnicity. The patient's height, and weight were not reported. No past medical history or concurrent conditions were reported. The patient received Covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin, and batch number were not reported) dose, 1 total start therapy date were not reported for prophylactic vaccination. The batch number was not reported. Per procedure, no follow-up will be requested for this case. No concomitant medications were reported. It was reported that "hopefully he contacts people like me that had major adverse reactions from the jab and have been diagnosed with vaccine induced thrombotic thrombocytopenia (VITT) and currently dealing with blocked splenic vein". The action taken with Covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from blocked splenic vein, and the outcome of vaccine induced thrombotic thrombocytopenia and major adverse reactions from the jab was not reported. This report was serious (Other Medically Important Condition). Version created to amend previously reported information on 03-MAR-2022. Upon review following information was amended the case validity was updated from invalid to valid. Sender's Comments: V1: This Version is created to amend previously reported information on 03-MAR-2022. Upon review following information was amended the case validity was updated from invalid to valid. This updated information does not alter the company causality of previously reported events. 20220311052-Covid-19 vaccine ad26.cov2.s -vaccine induced thrombotic thrombocytopenia ,Blocked splenic vein. This event(s) is labeled per RA and is therefore considered potentially related.
Age: 68.0
Sex: F
Vaccine: COVID19
Symptoms: Body temperature, Pyrexia
Clinical narrative: temperature about 102; This is a spontaneous report received from contactable reporter(s) (Other HCP). The reporter is the patient.  A 68 year-old female patient (not pregnant) received bnt162b2 (BNT162B2), administration date 20Aug2021 14:00 (Lot number: EW0712) at the age of 68 years as dose 1, single for covid-19 immunisation. Relevant medical history included: "COVID-19" (unspecified if ongoing), notes: had covid a month or two before the first covid shot. Concomitant medication(s) included: VIACTIV [CALCIUM]. Past drug history included: Tylenol, reaction(s): "Known allergies: Tylenol", notes: Tylenol, don't feel well, but I probably could take it.; Bicillin im, reaction(s): "Known allergies: Bicillin IM", notes: Bicillin IM. The following information was reported: PYREXIA (non-serious) with onset 2021, outcome "unknown", described as "temperature about 102". The patient underwent the following laboratory tests and procedures: body temperature: (2021) 102, notes: about 102. Additional information: After the first dose. the patient did OK, maybe a temperature about 102.
Age: 23.0
Sex: F
Vaccine: COVID19
Symptoms: Anosmia
Clinical narrative: Anosmia, still present as of 3/16/22
Age: 70.0
Sex: F
Vaccine: COVID19
Symptoms: Paraesthesia
Clinical narrative: Intermittent parenthesis of right cheek; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 70 year-old female patient (not pregnant) received bnt162b2 (BNT162B2), administered in arm left, administration date 23Mar2021 (Lot number: ER2613) at the age of 70 years as dose 2, single for covid-19 immunisation. The patient's relevant medical history was not reported. Concomitant medication(s) included: LEVOTHYROXINE; SIMVASTATIN; MELOXICAM; CYCLOBENZAPRIN. Past drug history included: Known allergies:augmentin, reaction(s): "Known allergies:Augmentin". Vaccination history included: Bnt162b2 (prev dose product=COVID 19, prev dose brand=Pfizer, prev dose brand unknown=False, prev dose lot number=EN6198, prev dose lot unknown=False, prev dose dose number=1, prev dose vaccine location=Left arm), administration date: 26Feb2021, when the patient was 70 years old, for Covid-19 Immunization. The following information was reported: PARAESTHESIA (non-serious) with onset 10Jun2021, outcome "not recovered", described as "Intermittent parenthesis of right cheek". Therapeutic measures were not taken as a result of paraesthesia  Additional information: Dose received- 3, Pfizer product of covid-19 with (lot number: Ewo183), administered in arm left, administration date 11Nov2021, administration time:03:15 AM. There are no any other vaccine in four weeks. Patient covid tested post vaccination with blood test on Sep2021 and positive result.  This follow-up is being submitted to notify that the lot/batch number is not available despite the follow-up attempts made. Follow-up attempts have been completed and no further information is expected
Age: 7.0
Sex: M
Vaccine: COVID19
Symptoms: Asthenia, Dry throat, Feeling abnormal, Hypervolaemia, Lethargy
Clinical narrative: off-Label Use; vaccine location: Right leg; Sore throat; throat feels weird; seems very dry; Drinking abnormal amounts of water; Very lethargic; pale; weak; Unable to attend school; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP).  A 7 year-old male patient received bnt162b2 (BNT162B2), administered in leg right, administration date 09Dec2021 17:00 (Lot number: FK5618) at the age of 7 years as dose 1, single for covid-19 immunisation; influenza vaccine (FLU), administered in leg left, administration date 09Dec2021 (Batch/Lot number: unknown) as dose 1, single for immunisation. Relevant medical history included: "Known allergies: Eggs" (unspecified if ongoing); "Known allergies: Peanuts" (unspecified if ongoing); "Known allergies: Sunflower" (unspecified if ongoing). Concomitant medication(s) included: MIRALAX. The following information was reported: OFF LABEL USE (non-serious) with onset 09Dec2021, outcome "unknown", described as "off-Label Use"; PRODUCT USE ISSUE (non-serious) with onset 09Dec2021, outcome "unknown", described as "vaccine location: Right leg"; OROPHARYNGEAL PAIN (non-serious) with onset 2021, outcome "not recovered", described as "Sore throat"; FEELING ABNORMAL (non-serious) with onset 2021, outcome "not recovered", described as "throat feels weird"; DRY THROAT (non-serious) with onset 2021, outcome "not recovered", described as "seems very dry"; HYPERVOLAEMIA (non-serious) with onset 2021, outcome "not recovered", described as "Drinking abnormal amounts of water"; LETHARGY (non-serious) with onset 2021, outcome "not recovered", described as "Very lethargic"; PALLOR (non-serious) with onset 2021, outcome "not recovered", described as "pale"; ASTHENIA (non-serious) with onset 2021, outcome "not recovered", described as "weak"; LOSS OF PERSONAL INDEPENDENCE IN DAILY ACTIVITIES (non-serious) with onset 2021, outcome "not recovered", described as "Unable to attend school". Therapeutic measures were not taken as a result of oropharyngeal pain, feeling abnormal, dry throat, hypervolaemia, lethargy, pallor, asthenia, loss of personal independence in daily activities.  Additional information: The patient did not have covid prior to vaccination. The patient was not tested for covid post vaccination. Follow-up attempts are completed. No further information is expected.  No follow-up attempts are possible. No further information is expected.
Age: 7.0
Sex: M
Vaccine: COVID19
Symptoms: Loss of personal independence in daily activities, Off label use, Oropharyngeal pain, Pallor, Product use issue
Clinical narrative: off-Label Use; vaccine location: Right leg; Sore throat; throat feels weird; seems very dry; Drinking abnormal amounts of water; Very lethargic; pale; weak; Unable to attend school; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP).  A 7 year-old male patient received bnt162b2 (BNT162B2), administered in leg right, administration date 09Dec2021 17:00 (Lot number: FK5618) at the age of 7 years as dose 1, single for covid-19 immunisation; influenza vaccine (FLU), administered in leg left, administration date 09Dec2021 (Batch/Lot number: unknown) as dose 1, single for immunisation. Relevant medical history included: "Known allergies: Eggs" (unspecified if ongoing); "Known allergies: Peanuts" (unspecified if ongoing); "Known allergies: Sunflower" (unspecified if ongoing). Concomitant medication(s) included: MIRALAX. The following information was reported: OFF LABEL USE (non-serious) with onset 09Dec2021, outcome "unknown", described as "off-Label Use"; PRODUCT USE ISSUE (non-serious) with onset 09Dec2021, outcome "unknown", described as "vaccine location: Right leg"; OROPHARYNGEAL PAIN (non-serious) with onset 2021, outcome "not recovered", described as "Sore throat"; FEELING ABNORMAL (non-serious) with onset 2021, outcome "not recovered", described as "throat feels weird"; DRY THROAT (non-serious) with onset 2021, outcome "not recovered", described as "seems very dry"; HYPERVOLAEMIA (non-serious) with onset 2021, outcome "not recovered", described as "Drinking abnormal amounts of water"; LETHARGY (non-serious) with onset 2021, outcome "not recovered", described as "Very lethargic"; PALLOR (non-serious) with onset 2021, outcome "not recovered", described as "pale"; ASTHENIA (non-serious) with onset 2021, outcome "not recovered", described as "weak"; LOSS OF PERSONAL INDEPENDENCE IN DAILY ACTIVITIES (non-serious) with onset 2021, outcome "not recovered", described as "Unable to attend school". Therapeutic measures were not taken as a result of oropharyngeal pain, feeling abnormal, dry throat, hypervolaemia, lethargy, pallor, asthenia, loss of personal independence in daily activities.  Additional information: The patient did not have covid prior to vaccination. The patient was not tested for covid post vaccination. Follow-up attempts are completed. No further information is expected.  No follow-up attempts are possible. No further information is expected.
Age: 55.0
Sex: F
Vaccine: COVID19
Symptoms: Myalgia
Clinical narrative: Pounding heart in my chest for 3-4 hours at bedtime before I took a gabapentin to finally fall asleep. Seemed like my heart rate was very, very rapid. I could not settle my heart rate down at all; I woke up feeling very tired; still with a very sore right arm muscle; a bad headache; as well as dizziness; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 55 year-old female patient (not pregnant) received bnt162b2 (BNT162B2), administered in arm right, administration date 09Dec2021 14:45 (Lot number: 33026BD) at the age of 55 years as dose 2 (booster), single for covid-19 immunization. Relevant medical history included: "My heart rate does get elevated/races after drinking alcohol (any type) '||CHR(38)||' caffeine. Otherwise very healthy" (unspecified if ongoing), notes: My heart rate does get elevated/races after drinking alcohol (any type) & caffeine. Otherwise very healthy; "Allergy: beeswax in lip balms" (unspecified if ongoing). The patient took concomitant medications. Vaccination history included: Johnson & Johnson (Dose Number: 1, Batch/Lot No: 043A21A, Location of injection: Arm Right, Vaccine Administration Time: 02:00 PM), administration date: 28May2021, when the patient was 54 years old, for COVID-19 immunization. The following information was reported: HEART RATE INCREASED (non-serious) with onset 09Dec2021 23:00, outcome "recovering", described as "Pounding heart in my chest for 3-4 hours at bedtime before I took a gabapentin to finally fall asleep. Seemed like my heart rate was very, very rapid. I could not settle my heart rate down at all"; FATIGUE (non-serious) with onset 09Dec2021 23:00, outcome "recovering", described as "I woke up feeling very tired"; MYALGIA (non-serious) with onset 09Dec2021 23:00, outcome "recovering", described as "still with a very sore right arm muscle"; HEADACHE (non-serious) with onset 09Dec2021 23:00, outcome "recovering", described as "a bad headache"; DIZZINESS (non-serious) with onset 09Dec2021 23:00, outcome "recovering", described as "as well as dizziness". Relevant laboratory tests and procedures are available in the appropriate section. Therapeutic measures were taken as a result of heart rate increased. Therapeutic measures were not taken as a result of fatigue, myalgia, headache, dizziness.  Additional information:Pounding heart in my chest for 3-4 hours at bedtime before I took a gabapentin to finally fall asleep. Seemed like my heart rate was very, very rapid. I could not settle my heart rate down at all. However I did take my own heart rate & it was only in the upper 60s bpm, so I did not go to the ER. But it still felt like my heart was working twice as hard as normal. I woke up feeling very tired, still with a very sore right arm muscle, a bad headache, as well as dizziness. But my heart rate was not elevated in the morning.  Follow-Up (15Dec2021): Follow-up attempts are completed. No further information is expected.  No follow-up attempts are possible. No further information is expected.