chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 91.0
Sex: M
Vaccine: COVID19
Symptoms: Rib fracture
Clinical narrative: Narrative:  90 yo male died at hospital on 12/19/2021 after being sent back there from rehab facility where he was residing due to recovery from broken 4 ribs after a fall at home. Pt. was dehydrated and dx with pneumonia.  (No mention of covid infection). Pt had received covid vaccines on 1/12/21, 2/9/21 & 9/8/21. Pt's problem list: Iron deficiency 09/16/2021 Weight loss 09/02/2021 Osteoarthritis of knee 03/09/2021 Constipation 09/18/2020 Orthostatic hypotension 07/24/2019 Vitamin B12 deficiency (non anemic) 07/24/2019 HTN - Hypertension 04/29/2019 Low back pain 04/29/2019 Benign prostatic hypertrophy without outflow 04/29/2019 obstruction GERD - Gastro-esophageal reflux disease 04/29/2019 Hyperlipidemia 06/04/2018 Chronic kidney disease stage 3 06/04/2018 Hearing loss 06/04/2018 Cardiac arrhythmia 02/04/2016 Edema 11/19/2015 Hyperparathyroidism due to renal insufficiency 11/19/2015 Major Depressive Disorder, Recurrent Episode, 07/30/2019 Moderate Degree Malignant neoplasm of upper limb 11/05/2014  Vitamin D Deficiency 07/02/2014 Personal History of other Mental Disorders 07/24/2019 Other B-complex deficiencies 07/02/2014 Malignant neoplasm of larynx 07/24/2019 Other nonspecific findings of urine 10/27/2016 Lack of Housing 08/29/2016 This death is likely not related to the vaccinations due to patient's comorbidities, advanced age, and length of time from vaccine administration.
Age: 64.0
Sex: M
Vaccine: COVID19
Symptoms: Death
Clinical narrative: Narrative: 63yo male in home community GEC care with PMH: Osteoarthritis Schizoaffective disorder, bipolar type Murmur Substance Abuse Negative PPD Tobacco user Essential hypertension Legal blindness died on 12/24/2021. Pt had received covid vaccines from Health dept on 1/16/21 & 2/6/21. This death is likely not related to the vaccinations due to patient's comorbidities, advanced age, and length of time from vaccine administration.
Age: 63.0
Sex: F
Vaccine: COVID19, COVID19, COVID19
Symptoms: Angina pectoris, Mobility decreased, Pain, Proctalgia
Clinical narrative: AFTER BOOSTER, CONTINUES PAIN THROUGH MY ENTIRE BODY, PAIN MORE SERVERE ON THE LEFT SIDE, SHARP PAINS IN HEART, DIFFCULTY LIFTING LEFT ARM, VERY PAINFUL, RECTAL AREA PAIN. AT TIMES I CAN FEEL VERY BONE IN MY BODY.
Age: 54.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Nasopharyngitis, Tinnitus
Clinical narrative: Tintinus ! from 10/21 - Now 1/22 My experience I did not have any adverse effects until I got my first cold. My last vax was 2/20/21, but I got a cold in October of 21 - and my ear started ringing from the onset of the cold. I had never had a problem with my ears in 55 years of life, and feel that my body reacted differently leaving me with this ringing in my left ear. It has been ringing from then until NOW - Jan of 22 and I see no signs of it stopping. I would joke that it was the vax, but then I read that other people have been experiencing tintinus since the vax as well. I am very alarmed by this.
Age: 27.0
Sex: F
Vaccine: COVID19
Symptoms: Pallor, Seizure, Tremor, Unresponsive to stimuli, Vomiting
Clinical narrative: patient became pale, starting seizing ~ 5 min after receiving the covid vaccine. her eyes were open, she was sitting up & shaking when RPh arrived. She was however unresponsive when RPh tried to talk to her. Seizure lasted ~ 2 min. Pt threw up at the end of it & then slowly came back.
Age: 68.0
Sex: M
Vaccine: COVID19
Symptoms: Arthralgia, Blood test normal, Contusion, Eating disorder, Injection site pain
Clinical narrative: I had a sore arm at the injections.  Then, I got a bad rash all over my body.  My right arm swelled up and started bruising.  I had joint pain in my knees and hip. I lost 30 lbs. and it was very hard to eat anything.  I went to my doctor about this.  They put me on a high dose of steroids'.  They did blood work, normal.
Age: 68.0
Sex: M
Vaccine: COVID19
Symptoms: Peripheral swelling, Rash, Weight decreased
Clinical narrative: I had a sore arm at the injections.  Then, I got a bad rash all over my body.  My right arm swelled up and started bruising.  I had joint pain in my knees and hip. I lost 30 lbs. and it was very hard to eat anything.  I went to my doctor about this.  They put me on a high dose of steroids'.  They did blood work, normal.
Age: 80.0
Sex: F
Vaccine: COVID19
Symptoms: Chills, Decreased appetite, Influenza like illness, Myalgia
Clinical narrative: No appetite after 2nd shot; Seem like FLU symptoms after 2nd shot; Chills without fever after 2nd shot; Muscle aches after 2nd shot; This spontaneous case was reported by a consumer and describes the occurrence of DECREASED APPETITE (No appetite after 2nd shot), INFLUENZA LIKE ILLNESS (Seem like FLU symptoms after 2nd shot), CHILLS (Chills without fever after 2nd shot) and MYALGIA (Muscle aches after 2nd shot) in an 80-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 003A21A, 006M20A and 032H21A) for COVID-19 vaccination.     Previously administered products included for Product used for unknown indication: Vitamins. Past adverse reactions to the above products included No adverse event with Vitamins. Concurrent medical conditions included Hypertension (High Blood Pressure controlled by medications).   On 15-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 16-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 10-Jan-2022, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 16-Mar-2021, the patient experienced DECREASED APPETITE (No appetite after 2nd shot), INFLUENZA LIKE ILLNESS (Seem like FLU symptoms after 2nd shot), CHILLS (Chills without fever after 2nd shot) and MYALGIA (Muscle aches after 2nd shot). On 19-Mar-2021, DECREASED APPETITE (No appetite after 2nd shot), INFLUENZA LIKE ILLNESS (Seem like FLU symptoms after 2nd shot), CHILLS (Chills without fever after 2nd shot) and MYALGIA (Muscle aches after 2nd shot) had resolved.            Patient medications include vitamins and blood pressure medications and also asked that when to restart them.  Patient did not experienced any events after booster shot when time of reporting.  No concomitant information was reported.  No treatment information was reported.
Age: 67.0
Sex: M
Vaccine: COVID19
Symptoms: Pain in extremity
Clinical narrative: sore arm for 1-2 hours; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 67 year-old male patient received bnt162b2 (BNT162B2), administered in arm left (Lot number: EL5246) at the age of 67 years as dose 1, single for covid-19 immunisation. The patient's relevant medical history was not reported. Concomitant medication(s) included: LISINOPRIL (ongoing). The following information was reported: PAIN IN EXTREMITY (non-serious), outcome "recovered", described as "sore arm for 1-2 hours".  No follow-up attempts are possible. No further information is expected.
Age: 17.0
Sex: F
Vaccine: COVID19
Symptoms: Anaphylactic reaction, Angioedema, Blood test, Urticaria
Clinical narrative: Anaphylaxis. Angioedema, hives
Age: 31.0
Sex: F
Vaccine: COVID19
Symptoms: Anion gap, Anxiety, Bacterial test negative, Basophil count decreased, Basophil percentage
Clinical narrative: Lightning headaches "brain zaps" for weeks afterward Felt like I was being strangled Right arm nerves inflamed and burning, felt like they were growing out of my arm Right leg grew numb and tingling, felt like I was walking on rocks for months  Doctor did nothing but provide anxiety medication when he told me I'd probably never walk again.
Age: 31.0
Sex: F
Vaccine: COVID19
Symptoms: Bilirubin urine, Blood calcium normal, Blood chloride normal, Blood creatinine normal, Blood glucose normal
Clinical narrative: Lightning headaches "brain zaps" for weeks afterward Felt like I was being strangled Right arm nerves inflamed and burning, felt like they were growing out of my arm Right leg grew numb and tingling, felt like I was walking on rocks for months  Doctor did nothing but provide anxiety medication when he told me I'd probably never walk again.
Age: 31.0
Sex: F
Vaccine: COVID19
Symptoms: Blood potassium normal, Blood sodium normal, Blood urea normal, Burning sensation, C-reactive protein normal
Clinical narrative: Lightning headaches "brain zaps" for weeks afterward Felt like I was being strangled Right arm nerves inflamed and burning, felt like they were growing out of my arm Right leg grew numb and tingling, felt like I was walking on rocks for months  Doctor did nothing but provide anxiety medication when he told me I'd probably never walk again.
Age: 31.0
Sex: F
Vaccine: COVID19
Symptoms: Carbon dioxide normal, Choking sensation, Chromaturia, Creatinine renal clearance decreased, Electric shock sensation
Clinical narrative: Lightning headaches "brain zaps" for weeks afterward Felt like I was being strangled Right arm nerves inflamed and burning, felt like they were growing out of my arm Right leg grew numb and tingling, felt like I was walking on rocks for months  Doctor did nothing but provide anxiety medication when he told me I'd probably never walk again.
Age: 31.0
Sex: F
Vaccine: COVID19
Symptoms: Eosinophil count normal, Eosinophil percentage, Gait inability, Glomerular filtration rate normal, Glucose urine absent
Clinical narrative: Lightning headaches "brain zaps" for weeks afterward Felt like I was being strangled Right arm nerves inflamed and burning, felt like they were growing out of my arm Right leg grew numb and tingling, felt like I was walking on rocks for months  Doctor did nothing but provide anxiety medication when he told me I'd probably never walk again.
Age: 31.0
Sex: F
Vaccine: COVID19
Symptoms: Haematocrit normal, Haemoglobin normal, Haemoglobin urine absent, Headache, Human chorionic gonadotropin negative
Clinical narrative: Lightning headaches "brain zaps" for weeks afterward Felt like I was being strangled Right arm nerves inflamed and burning, felt like they were growing out of my arm Right leg grew numb and tingling, felt like I was walking on rocks for months  Doctor did nothing but provide anxiety medication when he told me I'd probably never walk again.
Age: 31.0
Sex: F
Vaccine: COVID19
Symptoms: Hypoaesthesia, Lymphocyte count, Lymphocyte percentage, Mean cell haemoglobin concentration normal, Mean cell haemoglobin normal
Clinical narrative: Lightning headaches "brain zaps" for weeks afterward Felt like I was being strangled Right arm nerves inflamed and burning, felt like they were growing out of my arm Right leg grew numb and tingling, felt like I was walking on rocks for months  Doctor did nothing but provide anxiety medication when he told me I'd probably never walk again.
Age: 31.0
Sex: F
Vaccine: COVID19
Symptoms: Mean cell volume normal, Mean platelet volume normal, Monocyte count, Monocyte percentage increased, Neuritis
Clinical narrative: Lightning headaches "brain zaps" for weeks afterward Felt like I was being strangled Right arm nerves inflamed and burning, felt like they were growing out of my arm Right leg grew numb and tingling, felt like I was walking on rocks for months  Doctor did nothing but provide anxiety medication when he told me I'd probably never walk again.
Age: 31.0
Sex: F
Vaccine: COVID19
Symptoms: Neutrophil count, Neutrophil percentage, Nitrite urine absent, Paraesthesia, Platelet count normal
Clinical narrative: Lightning headaches "brain zaps" for weeks afterward Felt like I was being strangled Right arm nerves inflamed and burning, felt like they were growing out of my arm Right leg grew numb and tingling, felt like I was walking on rocks for months  Doctor did nothing but provide anxiety medication when he told me I'd probably never walk again.
Age: 31.0
Sex: F
Vaccine: COVID19
Symptoms: Protein urine absent, Red blood cell count normal, Red blood cell sedimentation rate increased, Red blood cells urine negative, Red cell distribution width normal
Clinical narrative: Lightning headaches "brain zaps" for weeks afterward Felt like I was being strangled Right arm nerves inflamed and burning, felt like they were growing out of my arm Right leg grew numb and tingling, felt like I was walking on rocks for months  Doctor did nothing but provide anxiety medication when he told me I'd probably never walk again.
Age: 31.0
Sex: F
Vaccine: COVID19
Symptoms: Sensory disturbance, Specific gravity urine normal, Urinary sediment present, Urine abnormality, Urine ketone body absent
Clinical narrative: Lightning headaches "brain zaps" for weeks afterward Felt like I was being strangled Right arm nerves inflamed and burning, felt like they were growing out of my arm Right leg grew numb and tingling, felt like I was walking on rocks for months  Doctor did nothing but provide anxiety medication when he told me I'd probably never walk again.
Age: 31.0
Sex: F
Vaccine: COVID19
Symptoms: Urine leukocyte esterase positive, Urobilinogen urine decreased, White blood cell count normal, White blood cells urine positive, pH urine normal
Clinical narrative: Lightning headaches "brain zaps" for weeks afterward Felt like I was being strangled Right arm nerves inflamed and burning, felt like they were growing out of my arm Right leg grew numb and tingling, felt like I was walking on rocks for months  Doctor did nothing but provide anxiety medication when he told me I'd probably never walk again.
Age: 79.0
Sex: F
Vaccine: COVID19
Symptoms: Guillain-Barre syndrome, Neuropathy peripheral
Clinical narrative: PERIPHERAL NEUROPATHY CAUSED BY GUILLIAN BARRE SYNDROME
Age: 61.0
Sex: F
Vaccine: COVID19
Symptoms: Hypoaesthesia, Nerve conduction studies
Clinical narrative: feet numb
Age: 75.0
Sex: M
Vaccine: COVID19
Symptoms: Acute kidney injury, Bradycardia, COVID-19, Cough, Death
Clinical narrative: pt presents to ED with difficulty breathing, cough and wheezing, worsening over past wk; was previously in hospital for 2 days with respiratory failure (positive for COVID), acute on chronic kidney injury, pneumonia in right upper lobe of lung; readmitted; received steroids, dexamethasone, vitamins C and D3, zinc; O2 supplementation with OptiFlow; pt's condition worsened and intubation with mechanical ventilation was required; condition deteriorated with drops in O2 sats, bradycardia, transient tremors; pt's family requested no chest compressions/debrillation; extubated per family's request; pt died in the hosp
Age: 75.0
Sex: M
Vaccine: COVID19
Symptoms: Dyspnoea, Endotracheal intubation, General physical health deterioration, Mechanical ventilation, Oxygen saturation decreased
Clinical narrative: pt presents to ED with difficulty breathing, cough and wheezing, worsening over past wk; was previously in hospital for 2 days with respiratory failure (positive for COVID), acute on chronic kidney injury, pneumonia in right upper lobe of lung; readmitted; received steroids, dexamethasone, vitamins C and D3, zinc; O2 supplementation with OptiFlow; pt's condition worsened and intubation with mechanical ventilation was required; condition deteriorated with drops in O2 sats, bradycardia, transient tremors; pt's family requested no chest compressions/debrillation; extubated per family's request; pt died in the hosp
Age: 75.0
Sex: M
Vaccine: COVID19
Symptoms: Pneumonia, Respiratory failure, SARS-CoV-2 test positive, Tremor, Wheezing
Clinical narrative: pt presents to ED with difficulty breathing, cough and wheezing, worsening over past wk; was previously in hospital for 2 days with respiratory failure (positive for COVID), acute on chronic kidney injury, pneumonia in right upper lobe of lung; readmitted; received steroids, dexamethasone, vitamins C and D3, zinc; O2 supplementation with OptiFlow; pt's condition worsened and intubation with mechanical ventilation was required; condition deteriorated with drops in O2 sats, bradycardia, transient tremors; pt's family requested no chest compressions/debrillation; extubated per family's request; pt died in the hosp
Age: 7.0
Sex: M
Vaccine: COVID19
Symptoms: Discomfort, Insomnia, Pruritus, Rash, Rash pruritic
Clinical narrative: Swollen face; rash on face, neck and torso; Itching; discomfort; trouble sleeping; scratches as a result of itchy rash; scratches as a result of itchy rash; This is a spontaneous report received from contactable reporter (Consumer or other non HCP). The reporter is the patient.  A 7-year-old male patient received bnt162b2 (BNT162B2), administered in arm left, administration date 05Nov2021 12:00 (Lot number: FK5127) at the age of 7 years as dose 1 (tris), single for covid-19 immunisation. The patient had no relevant medical history. There were no concomitant medications. The following information was reported: SWELLING FACE (non-serious) with onset 05Nov2021 20:00, outcome "not recovered", described as "Swollen face"; RASH (non-serious) with onset 05Nov2021, outcome "not recovered", described as "rash on face, neck and torso"; PRURITUS (non-serious) with onset 05Nov2021, outcome "not recovered", described as "Itching"; DISCOMFORT (non-serious) with onset 05Nov2021, outcome "not recovered", described as "discomfort"; INSOMNIA (non-serious) with onset 05Nov2021, outcome "not recovered", described as "trouble sleeping"; SCRATCH (non-serious), RASH PRURITIC (non-serious) all with onset 05Nov2021, outcome "not recovered" and all described as "scratches as a result of itchy rash". The events "swollen face", "rash on face, neck and torso", "itching", "discomfort", "trouble sleeping", and "scratches as a result of itchy rash" were evaluated at the physician office visit. Therapeutic measures were taken as a result of swelling face, rash, pruritus, discomfort, insomnia, scratch, rash pruritic.  Additional information: The patient experienced: swollen face, rash on face, neck and torso. itching and discomfort, trouble sleeping, scratches because of itchy rash. The patient went to an urgent care and received a steroid injection and a prednisone prescription. The rash was still present and interfering with sleep three days later. The patient had no known allergies. The patient did not receive any other vaccines within four weeks prior to the COVID vaccine. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient has not been tested for COVID-19.  Follow-up attempts are completed. No further information is expected.
Age: 7.0
Sex: M
Vaccine: COVID19
Symptoms: Scratch, Swelling face
Clinical narrative: Swollen face; rash on face, neck and torso; Itching; discomfort; trouble sleeping; scratches as a result of itchy rash; scratches as a result of itchy rash; This is a spontaneous report received from contactable reporter (Consumer or other non HCP). The reporter is the patient.  A 7-year-old male patient received bnt162b2 (BNT162B2), administered in arm left, administration date 05Nov2021 12:00 (Lot number: FK5127) at the age of 7 years as dose 1 (tris), single for covid-19 immunisation. The patient had no relevant medical history. There were no concomitant medications. The following information was reported: SWELLING FACE (non-serious) with onset 05Nov2021 20:00, outcome "not recovered", described as "Swollen face"; RASH (non-serious) with onset 05Nov2021, outcome "not recovered", described as "rash on face, neck and torso"; PRURITUS (non-serious) with onset 05Nov2021, outcome "not recovered", described as "Itching"; DISCOMFORT (non-serious) with onset 05Nov2021, outcome "not recovered", described as "discomfort"; INSOMNIA (non-serious) with onset 05Nov2021, outcome "not recovered", described as "trouble sleeping"; SCRATCH (non-serious), RASH PRURITIC (non-serious) all with onset 05Nov2021, outcome "not recovered" and all described as "scratches as a result of itchy rash". The events "swollen face", "rash on face, neck and torso", "itching", "discomfort", "trouble sleeping", and "scratches as a result of itchy rash" were evaluated at the physician office visit. Therapeutic measures were taken as a result of swelling face, rash, pruritus, discomfort, insomnia, scratch, rash pruritic.  Additional information: The patient experienced: swollen face, rash on face, neck and torso. itching and discomfort, trouble sleeping, scratches because of itchy rash. The patient went to an urgent care and received a steroid injection and a prednisone prescription. The rash was still present and interfering with sleep three days later. The patient had no known allergies. The patient did not receive any other vaccines within four weeks prior to the COVID vaccine. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient has not been tested for COVID-19.  Follow-up attempts are completed. No further information is expected.
Age: 35.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Abdominal discomfort, Abdominal pain upper, COVID-19, Chest X-ray normal, Haematemesis
Clinical narrative: Covid19 breakthrough.  1st Vaccine on 05/28/2021.  35 y/o with PMH presents to Ed with c/o vomiting bright red blood and an uneasy stomach.  Later vomited coffee ground emesis and had pain in upper mid abdomen.  Pt with low grade fevers, O2 sat room air 100% and CXR unremarkable.
Age: 35.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Pyrexia, SARS-CoV-2 test positive, Vaccine breakthrough infection
Clinical narrative: Covid19 breakthrough.  1st Vaccine on 05/28/2021.  35 y/o with PMH presents to Ed with c/o vomiting bright red blood and an uneasy stomach.  Later vomited coffee ground emesis and had pain in upper mid abdomen.  Pt with low grade fevers, O2 sat room air 100% and CXR unremarkable.
Age: 89.0
Sex: M
Vaccine: COVID19
Symptoms: Underdose
Clinical narrative: Given booster instead of primary dose
Age: 63.0
Sex: F
Vaccine: FLUC4, PPV
Symptoms: Immediate post-injection reaction, Injection site pain, Mobility decreased, Musculoskeletal stiffness, Pain
Clinical narrative: Immediate pain at injection site that increased in intensity to a severe level of 10 on a pain scale of 1-10. that level of pain lasted for 12 hours. The arm swelled to three times it's size and so had stiffness and loss of mobility without pain. That lasted four days. The pain persisted on a pain scale of 5 at the injection site continually to this date of 1/1/2022. The mobility of the arm causes pain in the arm to increase and spreads throughout the arm, not just the injection site. that pain scale is about a 5-7. There was no treatment other than ice the arm due to Pharmacist stating her corporate office will call me to manage this situation. I had one phone call that left a voicemail. I called back several times. I never received a call back for TWO WEEKS. I finally left a strong message and was called back on that day, January 9, 2022. I was told in Risk Management, that they do nothing for vaccine reactions and to fill out a report to VAERS. I had called my Clinic and went to see my doctor on January 9th.
Age: 63.0
Sex: F
Vaccine: FLUC4, PPV
Symptoms: Pain in extremity, Peripheral swelling
Clinical narrative: Immediate pain at injection site that increased in intensity to a severe level of 10 on a pain scale of 1-10. that level of pain lasted for 12 hours. The arm swelled to three times it's size and so had stiffness and loss of mobility without pain. That lasted four days. The pain persisted on a pain scale of 5 at the injection site continually to this date of 1/1/2022. The mobility of the arm causes pain in the arm to increase and spreads throughout the arm, not just the injection site. that pain scale is about a 5-7. There was no treatment other than ice the arm due to Pharmacist stating her corporate office will call me to manage this situation. I had one phone call that left a voicemail. I called back several times. I never received a call back for TWO WEEKS. I finally left a strong message and was called back on that day, January 9, 2022. I was told in Risk Management, that they do nothing for vaccine reactions and to fill out a report to VAERS. I had called my Clinic and went to see my doctor on January 9th.
Age: 56.0
Sex: F
Vaccine: COVID19
Symptoms: Burning sensation, Chest pain, Paraesthesia, Paraesthesia oral, SARS-CoV-2 antibody test
Clinical narrative: Tingling around neck, jaw, mouth and tongue; Tingling around neck, jaw, mouth and tongue; burning sensation around neck and chest; burning sensation around neck and chest; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 56 year-old female patient (not pregnant) received bnt162b2 (BNT162B2), administered in arm left, administration date 02Aug2021 16:30 (Lot number: FA6730) at the age of 56 years as dose 1, single for covid-19 immunisation. The patient's relevant medical history was not reported. Concomitant medication(s) included: SYNTHROID; ZOLOFT. Past drug history included: Tetanus vaccine, reaction(s): "known allergies: Tetanus vaccine", notes: known allergies: Tetanus vaccine; Toxoid, reaction(s): "known allergies: Toxoid", notes: known allergies: Toxoid. The following information was reported: PARAESTHESIA (disability), PARAESTHESIA ORAL (disability) all with onset 02Aug2021 16:45, outcome "unknown" and all described as "Tingling around neck, jaw, mouth and tongue"; BURNING SENSATION (disability), CHEST PAIN (disability) all with onset 02Aug2021 16:45, outcome "unknown" and all described as "burning sensation around neck and chest". The events "tingling around neck, jaw, mouth and tongue", "tingling around neck, jaw, mouth and tongue", "burning sensation around neck and chest" and "burning sensation around neck and chest" were evaluated at the physician office visit. The patient underwent the following laboratory tests and procedures: sars-cov-2 antibody test: (22Nov2021) negative, notes: Nasal Swab; sars-cov-2 test: (14May2021) negative, notes: Nasal Swab; (20Jul2021) negative, notes: Nasal Swab; (16Aug2021) negative, notes: Nasal Swab; (11Oct2021) negative, notes: Nasal Swab. Therapeutic measures were taken as a result of paraesthesia, paraesthesia oral, burning sensation, chest pain.  Clinical course: No other vaccine administered in four weeks.covid prior to  vaccination was no. Covid was tested post vaccination.Other medical history was extensive medical problems  No follow-up attempts are possible. No further information is expected.
Age: 56.0
Sex: F
Vaccine: COVID19
Symptoms: SARS-CoV-2 test
Clinical narrative: Tingling around neck, jaw, mouth and tongue; Tingling around neck, jaw, mouth and tongue; burning sensation around neck and chest; burning sensation around neck and chest; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 56 year-old female patient (not pregnant) received bnt162b2 (BNT162B2), administered in arm left, administration date 02Aug2021 16:30 (Lot number: FA6730) at the age of 56 years as dose 1, single for covid-19 immunisation. The patient's relevant medical history was not reported. Concomitant medication(s) included: SYNTHROID; ZOLOFT. Past drug history included: Tetanus vaccine, reaction(s): "known allergies: Tetanus vaccine", notes: known allergies: Tetanus vaccine; Toxoid, reaction(s): "known allergies: Toxoid", notes: known allergies: Toxoid. The following information was reported: PARAESTHESIA (disability), PARAESTHESIA ORAL (disability) all with onset 02Aug2021 16:45, outcome "unknown" and all described as "Tingling around neck, jaw, mouth and tongue"; BURNING SENSATION (disability), CHEST PAIN (disability) all with onset 02Aug2021 16:45, outcome "unknown" and all described as "burning sensation around neck and chest". The events "tingling around neck, jaw, mouth and tongue", "tingling around neck, jaw, mouth and tongue", "burning sensation around neck and chest" and "burning sensation around neck and chest" were evaluated at the physician office visit. The patient underwent the following laboratory tests and procedures: sars-cov-2 antibody test: (22Nov2021) negative, notes: Nasal Swab; sars-cov-2 test: (14May2021) negative, notes: Nasal Swab; (20Jul2021) negative, notes: Nasal Swab; (16Aug2021) negative, notes: Nasal Swab; (11Oct2021) negative, notes: Nasal Swab. Therapeutic measures were taken as a result of paraesthesia, paraesthesia oral, burning sensation, chest pain.  Clinical course: No other vaccine administered in four weeks.covid prior to  vaccination was no. Covid was tested post vaccination.Other medical history was extensive medical problems  No follow-up attempts are possible. No further information is expected.
Age: 45.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Burning sensation, Mechanical urticaria, Pain, Pruritus, Urticaria
Clinical narrative: Was covered in hives all over the body/ diagnosed with chronic hives/ break through hives; Dermographia; Doctor told her that this is an immune reaction, not an allergic reaction; This spontaneous case was reported by a consumer and describes the occurrence of URTICARIA (Was covered in hives all over the body/ diagnosed with chronic hives/ break through hives), MECHANICAL URTICARIA (Dermographia) and IMMUNE-MEDIATED ADVERSE REACTION (Doctor told her that this is an immune reaction, not an allergic reaction) in a 45-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 017F21A) for COVID-19 vaccination.     No Medical History information was reported.    On 12-Nov-2021, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 28-Nov-2021, the patient experienced URTICARIA (Was covered in hives all over the body/ diagnosed with chronic hives/ break through hives), MECHANICAL URTICARIA (Dermographia) and IMMUNE-MEDIATED ADVERSE REACTION (Doctor told her that this is an immune reaction, not an allergic reaction). The patient was treated with FEXOFENADINE HYDROCHLORIDE (ALLEGRA [FEXOFENADINE HYDROCHLORIDE]) for Hives and Dermographia, at an unspecified dose and frequency; FAMOTIDINE (PEPCID [FAMOTIDINE]) for Hives and Dermographia, at an unspecified dose and frequency; CETIRIZINE HYDROCHLORIDE (ZYRTEC [CETIRIZINE HYDROCHLORIDE]) for Hives and Dermographia, at an unspecified dose and frequency; LORATADINE (CLARITIN [LORATADINE]) for Hives and Dermographia, at an unspecified dose and frequency and PREDNISONE for Hives and Dermographia, at an unspecified dose and frequency. At the time of the report, URTICARIA (Was covered in hives all over the body/ diagnosed with chronic hives/ break through hives) and MECHANICAL URTICARIA (Dermographia) had not resolved and IMMUNE-MEDIATED ADVERSE REACTION (Doctor told her that this is an immune reaction, not an allergic reaction) outcome was unknown.            No concomitant medications were provided. Treatment medications also included OTC Antihistamines. The patient was covered in hives all over the body.The patient was diagnosed with chronic hives, and Dermographia. It was reported that the patient had received steroids( 5 days of prednisone), and OTC Antihistamines and tried all OTC. The patient still have break through hives. The doctor told that was an immune reaction, not an allergic reaction.   This case was linked to MOD-2022-447410, MOD-2022-447154 (Patient Link).
Age: 45.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Immune-mediated adverse reaction, Mechanical urticaria, Urticaria
Clinical narrative: Was covered in hives all over the body/ diagnosed with chronic hives/ break through hives; Dermographia; Doctor told her that this is an immune reaction, not an allergic reaction; This spontaneous case was reported by a consumer and describes the occurrence of URTICARIA (Was covered in hives all over the body/ diagnosed with chronic hives/ break through hives), MECHANICAL URTICARIA (Dermographia) and IMMUNE-MEDIATED ADVERSE REACTION (Doctor told her that this is an immune reaction, not an allergic reaction) in a 45-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 017F21A) for COVID-19 vaccination.     No Medical History information was reported.    On 12-Nov-2021, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 28-Nov-2021, the patient experienced URTICARIA (Was covered in hives all over the body/ diagnosed with chronic hives/ break through hives), MECHANICAL URTICARIA (Dermographia) and IMMUNE-MEDIATED ADVERSE REACTION (Doctor told her that this is an immune reaction, not an allergic reaction). The patient was treated with FEXOFENADINE HYDROCHLORIDE (ALLEGRA [FEXOFENADINE HYDROCHLORIDE]) for Hives and Dermographia, at an unspecified dose and frequency; FAMOTIDINE (PEPCID [FAMOTIDINE]) for Hives and Dermographia, at an unspecified dose and frequency; CETIRIZINE HYDROCHLORIDE (ZYRTEC [CETIRIZINE HYDROCHLORIDE]) for Hives and Dermographia, at an unspecified dose and frequency; LORATADINE (CLARITIN [LORATADINE]) for Hives and Dermographia, at an unspecified dose and frequency and PREDNISONE for Hives and Dermographia, at an unspecified dose and frequency. At the time of the report, URTICARIA (Was covered in hives all over the body/ diagnosed with chronic hives/ break through hives) and MECHANICAL URTICARIA (Dermographia) had not resolved and IMMUNE-MEDIATED ADVERSE REACTION (Doctor told her that this is an immune reaction, not an allergic reaction) outcome was unknown.            No concomitant medications were provided. Treatment medications also included OTC Antihistamines. The patient was covered in hives all over the body.The patient was diagnosed with chronic hives, and Dermographia. It was reported that the patient had received steroids( 5 days of prednisone), and OTC Antihistamines and tried all OTC. The patient still have break through hives. The doctor told that was an immune reaction, not an allergic reaction.   This case was linked to MOD-2022-447410, MOD-2022-447154 (Patient Link).
Age: 89.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Myalgia
Clinical narrative: COVID breakthrough case
Age: 89.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: COVID-19, SARS-CoV-2 test positive, Vaccine breakthrough infection
Clinical narrative: COVID breakthrough case
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Blood test normal, Chest X-ray normal, Dyskinesia, Electroencephalogram normal, Magnetic resonance imaging normal
Clinical narrative: This spontaneous report received from a consumer concerned a 51-year-old white, not Hispanic, or Latino male. The patient's height, and weight were not reported. No past medical history or concurrent conditions were reported. The patient received covid-19 vaccine (dose number in series 1) (suspension for injection, route of admin not reported, batch number: 1802068, expiry: UNKNOWN) dose was not reported, 1 total, administered on 07-MAR-2021 to right arm for prophylactic vaccination. No concomitant medications were reported.  On an unspecified date, the patient experienced progressive shaking progressive shaking his head, arms and hand which started mildly, unable to work (symptoms progressed almost every two days). His sodium level dropped and was hospitalized (date unspecified) (dose number in series 1). Laboratory data (dates unspecified) included: Blood test (NR: not provided) Not provided, EEG (Electroencephalogram) (NR: not provided) Did not find anything, MRI (Magnetic resonance imaging) (NR: not provided) Did not find anything, Sodium (NR: not provided) dropped, and X-ray (NR: not provided) did not find anything. The number of days of hospitalization was not reported and it was unsure if the patient discharged from the hospital. The action taken with covid-19 vaccine was not applicable. The patient had not recovered from progressive shaking his head, arms, and hand, and unable to work, and the outcome of sodium level dropped was not reported. This report was serious (Hospitalization Caused / Prolonged).; Sender's Comments: V0-20220117154-Covid-19 vaccine Sodium level dropped. This event(s) is considered unassessable. The event(s) has a compatible/suggestive temporal relationship, is unlabeled, and has unknown scientific plausibility. There is no information on any other factors potentially associated with the event(s).
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Tremor
Clinical narrative: This spontaneous report received from a consumer concerned a 51-year-old white, not Hispanic, or Latino male. The patient's height, and weight were not reported. No past medical history or concurrent conditions were reported. The patient received covid-19 vaccine (dose number in series 1) (suspension for injection, route of admin not reported, batch number: 1802068, expiry: UNKNOWN) dose was not reported, 1 total, administered on 07-MAR-2021 to right arm for prophylactic vaccination. No concomitant medications were reported.  On an unspecified date, the patient experienced progressive shaking progressive shaking his head, arms and hand which started mildly, unable to work (symptoms progressed almost every two days). His sodium level dropped and was hospitalized (date unspecified) (dose number in series 1). Laboratory data (dates unspecified) included: Blood test (NR: not provided) Not provided, EEG (Electroencephalogram) (NR: not provided) Did not find anything, MRI (Magnetic resonance imaging) (NR: not provided) Did not find anything, Sodium (NR: not provided) dropped, and X-ray (NR: not provided) did not find anything. The number of days of hospitalization was not reported and it was unsure if the patient discharged from the hospital. The action taken with covid-19 vaccine was not applicable. The patient had not recovered from progressive shaking his head, arms, and hand, and unable to work, and the outcome of sodium level dropped was not reported. This report was serious (Hospitalization Caused / Prolonged).; Sender's Comments: V0-20220117154-Covid-19 vaccine Sodium level dropped. This event(s) is considered unassessable. The event(s) has a compatible/suggestive temporal relationship, is unlabeled, and has unknown scientific plausibility. There is no information on any other factors potentially associated with the event(s).
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Blood sodium, Blood sodium decreased, Blood test, Electroencephalogram, Impaired work ability
Clinical narrative: This spontaneous report received from a consumer concerned a 51-year-old white, not Hispanic, or Latino male. The patient's height, and weight were not reported. No past medical history or concurrent conditions were reported. The patient received covid-19 vaccine (dose number in series 1) (suspension for injection, route of admin not reported, batch number: 1802068, expiry: UNKNOWN) dose was not reported, 1 total, administered on 07-MAR-2021 to right arm for prophylactic vaccination. No concomitant medications were reported.  On an unspecified date, the patient experienced progressive shaking progressive shaking his head, arms and hand which started mildly, unable to work (symptoms progressed almost every two days). His sodium level dropped and was hospitalized (date unspecified) (dose number in series 1). Laboratory data (dates unspecified) included: Blood test (NR: not provided) Not provided, EEG (Electroencephalogram) (NR: not provided) Did not find anything, MRI (Magnetic resonance imaging) (NR: not provided) Did not find anything, Sodium (NR: not provided) dropped, and X-ray (NR: not provided) did not find anything. The number of days of hospitalization was not reported and it was unsure if the patient discharged from the hospital. The action taken with covid-19 vaccine was not applicable. The patient had not recovered from progressive shaking his head, arms, and hand, and unable to work, and the outcome of sodium level dropped was not reported. This report was serious (Hospitalization Caused / Prolonged).; Sender's Comments: V0-20220117154-Covid-19 vaccine Sodium level dropped. This event(s) is considered unassessable. The event(s) has a compatible/suggestive temporal relationship, is unlabeled, and has unknown scientific plausibility. There is no information on any other factors potentially associated with the event(s).
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Magnetic resonance imaging, Tremor, X-ray
Clinical narrative: This spontaneous report received from a consumer concerned a 51-year-old white, not Hispanic, or Latino male. The patient's height, and weight were not reported. No past medical history or concurrent conditions were reported. The patient received covid-19 vaccine (dose number in series 1) (suspension for injection, route of admin not reported, batch number: 1802068, expiry: UNKNOWN) dose was not reported, 1 total, administered on 07-MAR-2021 to right arm for prophylactic vaccination. No concomitant medications were reported.  On an unspecified date, the patient experienced progressive shaking progressive shaking his head, arms and hand which started mildly, unable to work (symptoms progressed almost every two days). His sodium level dropped and was hospitalized (date unspecified) (dose number in series 1). Laboratory data (dates unspecified) included: Blood test (NR: not provided) Not provided, EEG (Electroencephalogram) (NR: not provided) Did not find anything, MRI (Magnetic resonance imaging) (NR: not provided) Did not find anything, Sodium (NR: not provided) dropped, and X-ray (NR: not provided) did not find anything. The number of days of hospitalization was not reported and it was unsure if the patient discharged from the hospital. The action taken with covid-19 vaccine was not applicable. The patient had not recovered from progressive shaking his head, arms, and hand, and unable to work, and the outcome of sodium level dropped was not reported. This report was serious (Hospitalization Caused / Prolonged).; Sender's Comments: V0-20220117154-Covid-19 vaccine Sodium level dropped. This event(s) is considered unassessable. The event(s) has a compatible/suggestive temporal relationship, is unlabeled, and has unknown scientific plausibility. There is no information on any other factors potentially associated with the event(s).
Age: 18.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Blood test, Electrocardiogram, Magnetic resonance imaging, Seizure
Clinical narrative: Patient experienced a seizure 4 days after 2 dose of pfizer vaccine
Age: 18.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Seizure
Clinical narrative: Patient experienced a seizure 4 days after 2 dose of pfizer vaccine
Age: 51.0
Sex: F
Vaccine: COVID19
Symptoms: Capillary fragility, Condition aggravated, Dyspnoea, Gait disturbance, Haematoma
Clinical narrative: Immediate scalp and ear itching went away within the hour. Over the next several weeks after the injection had problems with breathing, aerobic function, swelling in legs and torso, and trouble walking. I had noticeable discoloration in my legs for several weeks. I had lymphedema and venous insufficiency and they were both under control. However, over the last nine-plus months I have not been able to keep it in control. Additionally, I have new varicose veins, broken capillaries, small hematomas, and reddish splotches on the top of the left foot.
Age: 51.0
Sex: F
Vaccine: COVID19
Symptoms: Immediate post-injection reaction, Lymphoedema, Peripheral swelling, Peripheral venous disease, Pruritus
Clinical narrative: Immediate scalp and ear itching went away within the hour. Over the next several weeks after the injection had problems with breathing, aerobic function, swelling in legs and torso, and trouble walking. I had noticeable discoloration in my legs for several weeks. I had lymphedema and venous insufficiency and they were both under control. However, over the last nine-plus months I have not been able to keep it in control. Additionally, I have new varicose veins, broken capillaries, small hematomas, and reddish splotches on the top of the left foot.
Age: 51.0
Sex: F
Vaccine: COVID19
Symptoms: Rash macular, Skin discolouration, Swelling, Varicose vein
Clinical narrative: Immediate scalp and ear itching went away within the hour. Over the next several weeks after the injection had problems with breathing, aerobic function, swelling in legs and torso, and trouble walking. I had noticeable discoloration in my legs for several weeks. I had lymphedema and venous insufficiency and they were both under control. However, over the last nine-plus months I have not been able to keep it in control. Additionally, I have new varicose veins, broken capillaries, small hematomas, and reddish splotches on the top of the left foot.
Age: 12.0
Sex: M
Vaccine: COVID19
Symptoms: Haematuria
Clinical narrative: Hematuria (blood in urine)
Age: 59.0
Sex: F
Vaccine: VARZOS
Symptoms: Unevaluable event
Clinical narrative: Normal dosage of ibuprofen, 400 mgs
Age: 32.0
Sex: F
Vaccine: COVID19
Symptoms: Erythema, Induration, Pain of skin, Pruritus, Skin plaque
Clinical narrative: Large red plaque like patch. Hard to touch. Painful. Itchy.   2 inches in diameter. Larger today than yesterday
Age: 77.0
Sex: F
Vaccine: COVID19
Symptoms: Diarrhoea, Vomiting
Clinical narrative: Sudden, severe vomiting followed by diarrhea.
Age: 48.0
Sex: F
Vaccine: COVID19
Symptoms: Chromatopsia
Clinical narrative: I had about 15 minutes of kaleidoscope vision, circling rainbow lights, in my right eye.
Age: 27.0
Sex: F
Vaccine: COVID19
Symptoms: Urticaria
Clinical narrative: Urticaria started on the back of my body and would appear randomly on limbs, face and neck. The hives would disappear in about 2 hours but new ones would reappear in different areas. I tried using antihistamines (loratadine and Benadryl), but they provided minimal relief. Still having these symptoms daily and seems to be worse during the night.
Age: 72.0
Sex: F
Vaccine: COVID19
Symptoms: Chest pain, Cough, Dyspnoea, Fatigue, Nausea
Clinical narrative: Exhaustion, chest pain, coughing, difficulty catching breath, nausea,  lasted 3 days, and of course sore L arm.
Age: 72.0
Sex: F
Vaccine: COVID19
Symptoms: Pain in extremity
Clinical narrative: Exhaustion, chest pain, coughing, difficulty catching breath, nausea,  lasted 3 days, and of course sore L arm.
Age: 34.0
Sex: F
Vaccine: COVID19
Symptoms: Antiphospholipid antibodies negative, Arthralgia, Blood test, Hypoaesthesia, Joint swelling
Clinical narrative: The morning after my second vaccine my lymph nodes were so swollen that you could grab them. They were the size of a ping pong ball. And then about 3 weeks after I started noticing hand( fingers) being very swollen and hurting. They were hard to bend my fingers because they hurt so bad and they would go numb throughout the day. As time progressed the pain in my joints ta went from just my fingers to my knees and ankles and toes. My fingers and knees still swell a lot throughout the days and those and my ankles and toes hurt literally non stop. I have tried many different types of arthritis creams and pain releiving creams and muscle rubs. I have also tried peptides (pills and nasal sprays), cleanses like heavy metal detox and and antivax cleanse. My doctor also put me on metacam and gabapentin and nothing has helped. I saw an ortho specialist in 8/21 and just saw  a rheumatoid specialist on 1/3/22 and am waiting for all the blood tests he did to come back.
Age: 34.0
Sex: F
Vaccine: COVID19
Symptoms: Lymphadenopathy, Pain in extremity, Peripheral swelling, Rheumatoid factor negative
Clinical narrative: The morning after my second vaccine my lymph nodes were so swollen that you could grab them. They were the size of a ping pong ball. And then about 3 weeks after I started noticing hand( fingers) being very swollen and hurting. They were hard to bend my fingers because they hurt so bad and they would go numb throughout the day. As time progressed the pain in my joints ta went from just my fingers to my knees and ankles and toes. My fingers and knees still swell a lot throughout the days and those and my ankles and toes hurt literally non stop. I have tried many different types of arthritis creams and pain releiving creams and muscle rubs. I have also tried peptides (pills and nasal sprays), cleanses like heavy metal detox and and antivax cleanse. My doctor also put me on metacam and gabapentin and nothing has helped. I saw an ortho specialist in 8/21 and just saw  a rheumatoid specialist on 1/3/22 and am waiting for all the blood tests he did to come back.
Age: 12.0
Sex: M
Vaccine: COVID19
Symptoms: Incorrect dose administered
Clinical narrative: PFIZER PEDIATRIC DOSE GIVEN INSTEAD OF PFIZER 12 Y/O AND UP DOSE.