chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 56.0
Sex: F
Vaccine: VARZOS
Symptoms: Insomnia, Pain, Pain in extremity, Paraesthesia
Clinical narrative: I had the Shingrix vaccine administered Monday morning.  My symptoms were normal  - moderate soreness and redness and swelling at the injection sight followed by flu-like symptoms Tuesday.  Those were body aches and headache.  But overnight tonight I have pins and needles severe pain in my left ring fingertip.  It's making it difficult to sleep.  There isn't a physical sign, the pain is within.  Pressure helps alleviate the pain a little. I read online that these symptoms are supposed to occur in the trunk of the body but that's not happening.  I've got a stinging fingertip.
Age: 31.0
Sex: F
Vaccine: SMALLMNK
Symptoms: Incorrect route of product administration, No adverse event, Product administration error
Clinical narrative: Giving my first monkeypox vaccine to Lab staff as PEP and because the guidance stated deltoid I believed it was an intramuscular injection and gave it IM, however the next day realized dose should have been given SQ.  Incorrect administration error.  No adverse reactions reported by staff member.
Age: 6.0
Sex: M
Vaccine: COVID19
Symptoms: Urticaria
Clinical narrative: Hives within 15 minutes after onset of vaccine. Given benadryl and full resolution
Age: 7.0
Sex: F
Vaccine: COVID19, HEPA, VARCEL
Symptoms: Incorrect dose administered, No adverse event, Product administered to patient of inappropriate age
Clinical narrative: Patient was given the wrong dose (30 mcg/0.3mL) for her age. No adverse events were seen. I did not recheck the dose after it was drawn up. Parents were advised of error. They were given a number to call us if any adverse events were observed.
Age: 23.0
Sex: M
Vaccine: COVID19
Symptoms: Headache, Nausea, Pain, Pain in extremity, Visual impairment
Clinical narrative: Severe Headache, shooting pain down arm, vision issue, nausea
Age: 41.0
Sex: F
Vaccine: SMALLMNK
Symptoms: Incorrect route of product administration, No adverse event
Clinical narrative: Giving my first monkeypox vaccine to Lab staff as PEP and because guidance stated deltoid I believed it to be an intramuscular dose, however the next day I realized it should have been given SQ.  Administration route error.  No adverse reaction reported by staff member.
Age: 46.0
Sex: F
Vaccine: COVID19
Symptoms: Diarrhoea, Fatigue, Gait inability, Headache, Lower respiratory tract infection
Clinical narrative: I slept turned to my right arm it was a very very strong pain, my fingers my elbows my knees it was a pain as if it were arthritis I could not move my fingers because they were stiff but during the afternoon when I got home after the vaccine I began to feel a coldness in my chest and a sensation (it scared me), my head hurt terribly I could not walk almost my whole body hurt my pain was so strong that I took 4 pills of 500 acetaminophen it calmed the pain I was like that for two days and I was very, very tired and exhausted. A week has passed. Sometimes I get very strong pains in my head. I have to take 4 acetaminophen pills. It is the one thing that calms the pain and suddenly I get a little diarrhea, I did not want to get vaccinated but I have to go to travel and I have to be vaccinated, I regretted getting vaccinated but I have to do it because otherwise they would not receive me, I did not expect this to happen to me.
Age: 46.0
Sex: F
Vaccine: COVID19
Symptoms: Musculoskeletal stiffness, Pain, Pain in extremity
Clinical narrative: I slept turned to my right arm it was a very very strong pain, my fingers my elbows my knees it was a pain as if it were arthritis I could not move my fingers because they were stiff but during the afternoon when I got home after the vaccine I began to feel a coldness in my chest and a sensation (it scared me), my head hurt terribly I could not walk almost my whole body hurt my pain was so strong that I took 4 pills of 500 acetaminophen it calmed the pain I was like that for two days and I was very, very tired and exhausted. A week has passed. Sometimes I get very strong pains in my head. I have to take 4 acetaminophen pills. It is the one thing that calms the pain and suddenly I get a little diarrhea, I did not want to get vaccinated but I have to go to travel and I have to be vaccinated, I regretted getting vaccinated but I have to do it because otherwise they would not receive me, I did not expect this to happen to me.
Age: 69.0
Sex: F
Vaccine: COVID19
Symptoms: Biopsy, Rash, Rash pruritic
Clinical narrative: About one week after the second booster shot, I got an itchy rash that started on my legs, chest and back. I thought it was poison ivy but it didn't go away and is worse now. I've seen an allergist and a dermatologist. I have tried Prednisone, prescription antihistamine and a prescription topical ointment. The only thing that seemed to help was Prednisone but as soon as I stopped taking it, the rash came back, worse. It is incredibly itchy and is now on most parts of my body. I am waiting for biopsy results.
Age: 6.0
Sex: F
Vaccine: COVID19
Symptoms: Product preparation issue
Clinical narrative: The vaccine was not diluted before administering
Age: 39.0
Sex: F
Vaccine: COVID19
Symptoms: Arthralgia, Musculoskeletal stiffness, Myalgia
Clinical narrative: Severe muscle and joint pain and stiffness throughout body.  Taking ibuprofen and Tylenol.
Age: 62.0
Sex: M
Vaccine: COVID19
Symptoms: Arthralgia, Hypoaesthesia, Injected limb mobility decreased, Injection site pain
Clinical narrative: 24 hours post-vaccination severe pain in the joints and thirsty 2 days later but the pain at the application site in the right arm deltoid region persists to the present day in the application area hurts very strongly in certain movements of the arm causing limitation in my functions daily because pain is awakened but only in certain movements, and lately slight numbness in my fingertips, more accentuated in the right upper extremity.
Age: 42.0
Sex: M
Vaccine: COVID19
Symptoms: Activated partial thromboplastin time, Blood magnesium, Blood phosphorus, Blood thyroid stimulating hormone, C-reactive protein
Clinical narrative: Troponins over 3000, Myocarditis, Heart Cath, MRI, Chest X-Ray, Patient has 0 family history or personal of heart issues, no alcohol, smoking or drug usage, CBC W/differential, Magnesium, Comprehensive Metabolic Panel, Influenza A,B, Covid-19, Respiratory Virus Antigens Profile, UA W/Microscopic, EGD, Colonoscopy,  C-Reactive protein, ECG 12 Lead, Basci Metabolic Panel, Phosphorus, Sedimentation rate, Protime W/INNR, APTT, Thyroid stimulating hormone, Toxicology Screen, Urine, Glyco HGB,  Lipase, CT,
Age: 42.0
Sex: M
Vaccine: COVID19
Symptoms: Catheterisation cardiac, Chest X-ray, Colonoscopy, Computerised tomogram, Differential white blood cell count
Clinical narrative: Troponins over 3000, Myocarditis, Heart Cath, MRI, Chest X-Ray, Patient has 0 family history or personal of heart issues, no alcohol, smoking or drug usage, CBC W/differential, Magnesium, Comprehensive Metabolic Panel, Influenza A,B, Covid-19, Respiratory Virus Antigens Profile, UA W/Microscopic, EGD, Colonoscopy,  C-Reactive protein, ECG 12 Lead, Basci Metabolic Panel, Phosphorus, Sedimentation rate, Protime W/INNR, APTT, Thyroid stimulating hormone, Toxicology Screen, Urine, Glyco HGB,  Lipase, CT,
Age: 42.0
Sex: M
Vaccine: COVID19
Symptoms: Electrocardiogram, Full blood count, Glycosylated haemoglobin, Influenza A virus test, Influenza B virus test
Clinical narrative: Troponins over 3000, Myocarditis, Heart Cath, MRI, Chest X-Ray, Patient has 0 family history or personal of heart issues, no alcohol, smoking or drug usage, CBC W/differential, Magnesium, Comprehensive Metabolic Panel, Influenza A,B, Covid-19, Respiratory Virus Antigens Profile, UA W/Microscopic, EGD, Colonoscopy,  C-Reactive protein, ECG 12 Lead, Basci Metabolic Panel, Phosphorus, Sedimentation rate, Protime W/INNR, APTT, Thyroid stimulating hormone, Toxicology Screen, Urine, Glyco HGB,  Lipase, CT,
Age: 42.0
Sex: M
Vaccine: COVID19
Symptoms: International normalised ratio, Lipase, Magnetic resonance imaging, Metabolic function test, Microscopy
Clinical narrative: Troponins over 3000, Myocarditis, Heart Cath, MRI, Chest X-Ray, Patient has 0 family history or personal of heart issues, no alcohol, smoking or drug usage, CBC W/differential, Magnesium, Comprehensive Metabolic Panel, Influenza A,B, Covid-19, Respiratory Virus Antigens Profile, UA W/Microscopic, EGD, Colonoscopy,  C-Reactive protein, ECG 12 Lead, Basci Metabolic Panel, Phosphorus, Sedimentation rate, Protime W/INNR, APTT, Thyroid stimulating hormone, Toxicology Screen, Urine, Glyco HGB,  Lipase, CT,
Age: 42.0
Sex: M
Vaccine: COVID19
Symptoms: Myocarditis, Oesophagogastroduodenoscopy, Prothrombin time, Red blood cell sedimentation rate, Respiratory viral panel
Clinical narrative: Troponins over 3000, Myocarditis, Heart Cath, MRI, Chest X-Ray, Patient has 0 family history or personal of heart issues, no alcohol, smoking or drug usage, CBC W/differential, Magnesium, Comprehensive Metabolic Panel, Influenza A,B, Covid-19, Respiratory Virus Antigens Profile, UA W/Microscopic, EGD, Colonoscopy,  C-Reactive protein, ECG 12 Lead, Basci Metabolic Panel, Phosphorus, Sedimentation rate, Protime W/INNR, APTT, Thyroid stimulating hormone, Toxicology Screen, Urine, Glyco HGB,  Lipase, CT,
Age: 42.0
Sex: M
Vaccine: COVID19
Symptoms: SARS-CoV-2 test, Toxicologic test, Troponin increased, Urine analysis
Clinical narrative: Troponins over 3000, Myocarditis, Heart Cath, MRI, Chest X-Ray, Patient has 0 family history or personal of heart issues, no alcohol, smoking or drug usage, CBC W/differential, Magnesium, Comprehensive Metabolic Panel, Influenza A,B, Covid-19, Respiratory Virus Antigens Profile, UA W/Microscopic, EGD, Colonoscopy,  C-Reactive protein, ECG 12 Lead, Basci Metabolic Panel, Phosphorus, Sedimentation rate, Protime W/INNR, APTT, Thyroid stimulating hormone, Toxicology Screen, Urine, Glyco HGB,  Lipase, CT,
Age: 64.0
Sex: F
Vaccine: COVID19
Symptoms: Chest pain, Laboratory test
Clinical narrative: Cardiac changes: Chest pains, Medical treatment, Continued cardiac follow ups.
Age: 5.0
Sex: F
Vaccine: COVID19
Symptoms: Incorrect dose administered
Clinical narrative: 5-year-old received the wrong dose of vaccine. She received 0.25mL of the adult vaccine equaling 50mg dose versus the 25mg she was supposed to get. Her mom called. Currently no issues. No symptoms. No complaints.
Age: 12.0
Sex: M
Vaccine: COVID19
Symptoms: Disorientation, Dizziness, Respiration abnormal, Syncope
Clinical narrative: Patient presented to pharmacy to receive their 2nd dose of Pfizer covid vaccine. Per patients father no adverse event reported with previous vaccination or any vaccination. Patient received the vaccine in the right arm and as we started to fill out the vaccine card the patient stood up to be closer to his father and fainted. The father prevented the patient from hitting his head on the ground and the patient had already woken up by the time of pharmacist getting to him. Patient was disoriented but began to respond to questions and asked what happened. The patient remained laying down for 5 minutes and attempted to sit in a chair. Was given orange juice and water as he had not eaten or drank since lunch around 2 pm He continued Upon sitting in the chair it was observed he began to breath heavier. Patient stated he felt dizzy and was again instructed to lie down and raise legs. Epipen was not administered but brought out in case of further reaction. Technician was called in to be ready to dial 911 if any other symptoms started. Patient was given 25 mg of Benadryl as it was the closet to vaccine room. He stated he was improving and did not have any more dizziness. Patient was kept lying down for 10 more minutes. Patient was then raised to a seated position against the wall and monitored for any more symptoms. After another 10 minutes patient felt well enough to stand. Father and pharmacist helped patient to his feet and held on to his arms in case of another reaction. Patient then sat in chair for another 5-10 minutes and was given a second dose of benadryl when discovered it was the 25 mg dose. Patient felt good and reported no symptoms after another 5-10 minutes and felt he could walk on his own. Patient was walked out while pharmacist carried an epi pen with the to ensure it was available if needed. Patient stated they felt no more symptoms and. Father was asked if he had any questions or concerns. Instructed father that if any other symptoms start again he is to be taken to emergency room. Father said he understood. In total around 45 minutes to 1 hour of attention were given to patient to ensure treatment was readily available.
Age: 74.0
Sex: M
Vaccine: COVID19, COVID19, COVID19, COVID19
Symptoms: Hypoxia, Pyrexia
Clinical narrative: Narrative:  73 year old male admitted on July 19 2022 with fever and hypoxia. He had received Pfizer vaccine x 3 on January 22 2021, February 10 2021, December 20 2021 and moderna x 1 on June 7 2022. He was treated with remdesivir 200 mg x 1 then 100 mg IV daily x 4 days and dexamethasone 6 mg daily x 5 days.. He clinically improved on treatment and was transferred off acute care unit on 7/26
Age: 63.0
Sex: M
Vaccine: COVID19, COVID19, COVID19, COVID19
Symptoms: Cough, Nasal congestion, Productive cough, Pyrexia
Clinical narrative: Narrative: 63 year old male admitted on July 31 2022 with cough, clear sputum, low graede fever and nasal congestion. He had received Moderna vaccine x 4 on December 28, 2020, January 25, 2021, October 19, 2021, June 9, 2022. He was treated with remdesivie 200 mg IV x1 then 100 mg daily x2 days and dexamethamethasone 6 mg x5 days. he rapidly improved and was transferred from acute care unit on 8/2/22.
Age: 78.0
Sex: M
Vaccine: VARZOS
Symptoms: Lip swelling
Clinical narrative: Narrative:  Pt received a zoster vaccine on 3/17/2016 at Primary Care Clinic. On 3/18/2016 pt presented to ER with swollen upper lip. Pt was given oral prednisone & oral diphenhydramine to continue at home for 5 days and discharge home. Condition resolved. Primary Care provider flagged pt chart on 7/28/22 with history of this ADR.
Age: 77.0
Sex: M
Vaccine: COVID19, COVID19, COVID19
Symptoms: Unevaluable event
Clinical narrative: Narrative:
Age: 54.0
Sex: F
Vaccine: COVID19
Symptoms: Swelling
Clinical narrative: Narrative: Pt reports "extreme swelling" after getting COVID vaccine booster. She tolerated dose 1 and 2 fine.
Age: 97.0
Sex: M
Vaccine: COVID19, COVID19, COVID19
Symptoms: Metabolic encephalopathy
Clinical narrative: Narrative:  Acute Metabolic Encephalopathy
Age: 52.0
Sex: F
Vaccine: COVID19
Symptoms: Nausea, Peripheral swelling, Vomiting
Clinical narrative: Narrative:  Pt experienced n/v and arm swelling after vaccine
Age: 33.0
Sex: M
Vaccine: COVID19
Symptoms: Mass
Clinical narrative: Narrative: had lumps all over his chest and his axilla after receiving vaccine. he did not receive second dose as he was advised against it by his provider.
Age: 69.0
Sex: F
Vaccine: COVID19
Symptoms: Confusional state, Lethargy
Clinical narrative: Narrative:  Patient required 24/7 observation after the vaccine due to severe lethargy and confusion.
Age: 90.0
Sex: M
Vaccine: COVID19, COVID19, COVID19, COVID19
Symptoms: Chills, Hypoxia, Productive cough, Pyrexia
Clinical narrative: Narrative: 89 year old male admitted on August 11 2022 with chills, productive cough, and fever with mild hypoxia. He had received Moderna vaccine x 4 on January 21 2021, February 17 2021, August 31, 2021, May 4 2022. He was treated with remdesivir 200 mg x 1 then 100 mg daily x 3 days and dexamethasone 6 mg IV x 5 days. He clinically improved and was discharged home on 8/16/2022.
Age: 75.0
Sex: M
Vaccine: COVID19
Symptoms: Fall
Clinical narrative: Narrative: Pt received vaccine the previous day, fell in dining room following day. Also being assessed for concomitant UTI.
Age: 88.0
Sex: M
Vaccine: VARZOS
Symptoms: Adverse drug reaction, Lip swelling, Rash
Clinical narrative: Narrative:  Pt received Zoster Shingles vaccine on 7/15/22. On 7/17/22 around midnight pt experienced lip swelling and rash. Pt presented to ER dept early morning of 7/18/22. Pt was treated with famotidine iv, diphenhydramine iv, & methylprednisolone ivp. Pt was admitted to hospital for monitoring but discharged home with EpiPen & Oral Prednisone Rx same day. MD flagged chart with ADR.
Age: 86.0
Sex: M
Vaccine: COVID19, COVID19, COVID19, COVID19
Symptoms: COVID-19, Inappropriate schedule of product administration, Pyrexia
Clinical narrative: Narrative: 86 year old male admitted on August 6 2022 with from CLC COVID-19 infection with fever. He had received Moderna x 4 on December 28 2020, January 27 2021, October 29 2021, June 9 2022. He was treated with remdesivir 200 mg x 1 then 100 mg daily x 4 days and dexamethasone 6 mg IV daily x 5 days.. He improved on treatment and was discharged from acute medicine floor on 8/11/2022.
Age: 76.0
Sex: F
Vaccine: COVID19, COVID19, COVID19, COVID19
Symptoms: Dizziness, Dry mouth, Hypertension, Vaccination site swelling
Clinical narrative: Narrative: Transported patient to the emergency department via wheelchair for high bp, dry mouth, swelling sensation on right deltoid (covid vaccine site), and light headedness after receiving 2nd covid booster (Pfizer). Charge nurse and nurse manager made aware. Transported patient in stable condition. Not in any type of distress. Report given to RN at 1018am. NO further questions/ concerns at this moment.
Age: 94.0
Sex: M
Vaccine: COVID19
Symptoms: Asthenia, Fall
Clinical narrative: Narrative:  94 yo patient s/p covid vaccine on 6/16/22 felt weak got up off his recliner and walked to the bathroom and fell on the floor patient crawled over to phone and called neighbor to pick him up and put him inrecliner. he rested in recliner all day and then next day felt fine no injuriesno hitting head
Age: 81.0
Sex: M
Vaccine: COVID19, FLU4
Symptoms: Unevaluable event
Clinical narrative: Narrative:
Age: 79.0
Sex: M
Vaccine: COVID19
Symptoms: Dyspnoea
Clinical narrative: Narrative: Dyspnea reported w/ 3rd vaccine dose. no adr recorded for prior doses.
Age: 55.0
Sex: M
Vaccine: COVID19
Symptoms: Blindness unilateral
Clinical narrative: Narrative:  New Patient to program reported to new primary care provider on 6/10/22 that he had received a covid vaccine (Pfizer) at facility on 1/12/2021 which caused transient right eye blindness with some residual loss. PPC reported ADE as historical ADR to vaccine. Pt is employee at facility, likely received vaccine there.
Age: 62.0
Sex: M
Vaccine: COVID19
Symptoms: Respiratory arrest
Clinical narrative: Narrative: Patient says he got the 1st Pfizer COVID vaccine on 10/6/21, then went in to respiratory arrest 10/9/2021. He says he was admitted to an outside hospital for 3 days and will have records sent to the facility. He says he was treated with steroids and a zpak. He says he was not intubated.
Age: 24.0
Sex: F
Vaccine: COVID19
Symptoms: Back pain, Chills, Headache, Injection site pain, Neck pain
Clinical narrative: Client reports symptoms started 8-13-22 @ 5:00am, awoke chills, pain of neck,  head, and back at that time took 1000mg Tylenol fever was 103.6, took luke warm bath tempt went down to 100, but tempt went back up to 102 she started throwing up for several hours. Fever went down to normal @4:30. On 8-14-22 her arm was painful at injection site did have fever of 101 8-15-22 2:30 client called reports painful arm enc her to contact her PCP.
Age: 24.0
Sex: F
Vaccine: COVID19
Symptoms: Pain in extremity, Pyrexia, Vomiting
Clinical narrative: Client reports symptoms started 8-13-22 @ 5:00am, awoke chills, pain of neck,  head, and back at that time took 1000mg Tylenol fever was 103.6, took luke warm bath tempt went down to 100, but tempt went back up to 102 she started throwing up for several hours. Fever went down to normal @4:30. On 8-14-22 her arm was painful at injection site did have fever of 101 8-15-22 2:30 client called reports painful arm enc her to contact her PCP.
Age: 33.0
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, SARS-CoV-2 test, Vaccination failure
Clinical narrative: COVID 19 Treatment; COVID 19 Treatment; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 34-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 11Apr2021 as dose 1, single (Lot number: ER8737), in right arm and on 06May2021 as dose 2, single (Lot number: EW0175) at the age of 33 years, in right arm for covid-19 immunisation. The patient's relevant medical history included: "anxiety/depression" (unspecified if ongoing); "anxiety/depression" (unspecified if ongoing); "ADHD" (unspecified if ongoing); "dust allergy" (unspecified if ongoing). Concomitant medication(s) included: ACETAMINOPHEN; BUSPIRONE; CONCERTA; WELLBUTRIN. The following information was reported: VACCINATION FAILURE (medically significant), COVID-19 (medically significant), outcome "unknown" and all described as "COVID 19 Treatment". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: Positive, notes: Treatment of COVID-19. Therapeutic measures were taken as a result of vaccination failure, covid-19.
Age: 81.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Angiogram cerebral abnormal, Aphasia, Brain oedema, COVID-19, Cerebral artery occlusion
Clinical narrative: MODERNA COVID VACCINE #3 GIVEN 12/8/21, LOT #012H21B; 6/8/22 pt had a colonoscopy and was dc'd to home without complications; later in the day, family found pt with sx of a stroke; EMS called and transported pt to hospital; aphasia, slurred speech, left hemiparesis; given TNK; thrombectomy; 6/12/22 pt developed fever and became hypoxic; found to be positive for COVID; pt's condition did not improve; transitioned to comfort care; pt passed away the following day
Age: 81.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Cerebral infarction, Colonoscopy, Computerised tomogram head abnormal, Dysarthria, Exposure to SARS-CoV-2
Clinical narrative: MODERNA COVID VACCINE #3 GIVEN 12/8/21, LOT #012H21B; 6/8/22 pt had a colonoscopy and was dc'd to home without complications; later in the day, family found pt with sx of a stroke; EMS called and transported pt to hospital; aphasia, slurred speech, left hemiparesis; given TNK; thrombectomy; 6/12/22 pt developed fever and became hypoxic; found to be positive for COVID; pt's condition did not improve; transitioned to comfort care; pt passed away the following day
Age: 81.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Hemiparesis, Hypoxia, Magnetic resonance imaging abnormal, Neurological symptom, Pyrexia
Clinical narrative: MODERNA COVID VACCINE #3 GIVEN 12/8/21, LOT #012H21B; 6/8/22 pt had a colonoscopy and was dc'd to home without complications; later in the day, family found pt with sx of a stroke; EMS called and transported pt to hospital; aphasia, slurred speech, left hemiparesis; given TNK; thrombectomy; 6/12/22 pt developed fever and became hypoxic; found to be positive for COVID; pt's condition did not improve; transitioned to comfort care; pt passed away the following day
Age: 81.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: SARS-CoV-2 test positive, Thrombectomy
Clinical narrative: MODERNA COVID VACCINE #3 GIVEN 12/8/21, LOT #012H21B; 6/8/22 pt had a colonoscopy and was dc'd to home without complications; later in the day, family found pt with sx of a stroke; EMS called and transported pt to hospital; aphasia, slurred speech, left hemiparesis; given TNK; thrombectomy; 6/12/22 pt developed fever and became hypoxic; found to be positive for COVID; pt's condition did not improve; transitioned to comfort care; pt passed away the following day
Age: 81.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Aphasia, COVID-19, Colonoscopy, Death, Dysarthria
Clinical narrative: MODERNA COVID VACCINE #3 GIVEN 12/8/21, LOT #012H21B; 6/8/22 pt had a colonoscopy and was dc'd to home without complications; later in the day, family found pt with sx of a stroke; EMS called and transported pt to hospital; aphasia, slurred speech, left hemiparesis; given TNK; thrombectomy; 6/12/22 pt developed fever and became hypoxic; found to be positive for COVID; pt's condition did not improve; transitioned to comfort care; pt passed away the following day
Age: 81.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Hemiparesis, Hypoxia, Neurological symptom, Pyrexia, SARS-CoV-2 test positive
Clinical narrative: MODERNA COVID VACCINE #3 GIVEN 12/8/21, LOT #012H21B; 6/8/22 pt had a colonoscopy and was dc'd to home without complications; later in the day, family found pt with sx of a stroke; EMS called and transported pt to hospital; aphasia, slurred speech, left hemiparesis; given TNK; thrombectomy; 6/12/22 pt developed fever and became hypoxic; found to be positive for COVID; pt's condition did not improve; transitioned to comfort care; pt passed away the following day
Age: 81.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Thrombectomy
Clinical narrative: MODERNA COVID VACCINE #3 GIVEN 12/8/21, LOT #012H21B; 6/8/22 pt had a colonoscopy and was dc'd to home without complications; later in the day, family found pt with sx of a stroke; EMS called and transported pt to hospital; aphasia, slurred speech, left hemiparesis; given TNK; thrombectomy; 6/12/22 pt developed fever and became hypoxic; found to be positive for COVID; pt's condition did not improve; transitioned to comfort care; pt passed away the following day
Age: 49.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Feeling hot, Movement disorder, Pain, Swelling
Clinical narrative: She states that following the booster, she began experiencing sensations of swelling and pain associated with her left deltoid, which was diagnosed as an infection.  This was treated with antibiotics.  She, in addition, developed sensations of numbness, and radicular symptoms radiating all way down the arm to the hand in the ulnar digits.  She states she has numbness associated with her lateral mandibular region and pain radiating from her lateral neck on the left-hand side down the arm into the ulnar digits.    She underwent surgery on 6/20/2022 (left shoulder arthroscopic manipulation and capsular release). Followed by extensive physical therapy.
Age: 49.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Arthroscopy, Hypoaesthesia, Injection site infection, Injection site pain, Injection site swelling
Clinical narrative: She states that following the booster, she began experiencing sensations of swelling and pain associated with her left deltoid, which was diagnosed as an infection.  This was treated with antibiotics.  She, in addition, developed sensations of numbness, and radicular symptoms radiating all way down the arm to the hand in the ulnar digits.  She states she has numbness associated with her lateral mandibular region and pain radiating from her lateral neck on the left-hand side down the arm into the ulnar digits.    She underwent surgery on 6/20/2022 (left shoulder arthroscopic manipulation and capsular release). Followed by extensive physical therapy.
Age: 49.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Laboratory test abnormal, Magnetic resonance imaging, Neck pain, Pain, Pain in extremity
Clinical narrative: She states that following the booster, she began experiencing sensations of swelling and pain associated with her left deltoid, which was diagnosed as an infection.  This was treated with antibiotics.  She, in addition, developed sensations of numbness, and radicular symptoms radiating all way down the arm to the hand in the ulnar digits.  She states she has numbness associated with her lateral mandibular region and pain radiating from her lateral neck on the left-hand side down the arm into the ulnar digits.    She underwent surgery on 6/20/2022 (left shoulder arthroscopic manipulation and capsular release). Followed by extensive physical therapy.
Age: 49.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Surgery
Clinical narrative: She states that following the booster, she began experiencing sensations of swelling and pain associated with her left deltoid, which was diagnosed as an infection.  This was treated with antibiotics.  She, in addition, developed sensations of numbness, and radicular symptoms radiating all way down the arm to the hand in the ulnar digits.  She states she has numbness associated with her lateral mandibular region and pain radiating from her lateral neck on the left-hand side down the arm into the ulnar digits.    She underwent surgery on 6/20/2022 (left shoulder arthroscopic manipulation and capsular release). Followed by extensive physical therapy.
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Protein total decreased, Rheumatoid arthritis, Rheumatoid factor positive
Clinical narrative: EARLY-STAGE RHEUMATOID ARTHRITIS; This spontaneous report received from a patient concerned a male of unspecified age, race and ethnicity. The patient's weight, height, and medical history were not reported. The patient was previously treated with covid-19 vaccine ad26. cov2. s (unspecified manufacturer) (dose number in series was 1) (suspension for injection, route of admin not reported, batch number: unknown, expiry: unknown) for covid-19 prophylaxis.  No adverse events were reported following vaccination with covid-19 vaccine ad26. cov2. s (dose number in series was 1). The patient received covid-19 vaccine ad26.cov2.s (dose number in series was 2) (suspension for injection, route of admin not reported, batch number: unknown, expiry: unknown) 1 total dose, start therapy date were not reported for covid-19 prophylaxis. The batch number was not reported and has been requested. No concomitant medications were reported.  On an unspecified date, the patient developed arthritis symptoms that kept getting worse. After months, it was verified as early-stage rheumatoid arthritis (dose number in series was 2). The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of early-stage rheumatoid arthritis was not reported. This report was serious (Other Medically Important Condition).; Sender's Comments: V0:20220829623-COVID-19 VACCINE AD26.COV2.S-early-stage rheumatoid arthritis.The event(s) has an unknown/unclear temporal relationship, is unlabeled, and has unknown scientific plausibility. There is no information on any other factors potentially associated with the event(s). Therefore, this event(s) is considered unassessable.
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Rheumatoid arthritis
Clinical narrative: EARLY-STAGE RHEUMATOID ARTHRITIS; This spontaneous report received from a patient concerned a male of unspecified age, race and ethnicity. The patient's weight, height, and medical history were not reported. The patient was previously treated with covid-19 vaccine ad26. cov2. s (unspecified manufacturer) (dose number in series was 1) (suspension for injection, route of admin not reported, batch number: unknown, expiry: unknown) for covid-19 prophylaxis.  No adverse events were reported following vaccination with covid-19 vaccine ad26. cov2. s (dose number in series was 1). The patient received covid-19 vaccine ad26.cov2.s (dose number in series was 2) (suspension for injection, route of admin not reported, batch number: unknown, expiry: unknown) 1 total dose, start therapy date were not reported for covid-19 prophylaxis. The batch number was not reported and has been requested. No concomitant medications were reported.  On an unspecified date, the patient developed arthritis symptoms that kept getting worse. After months, it was verified as early-stage rheumatoid arthritis (dose number in series was 2). The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of early-stage rheumatoid arthritis was not reported. This report was serious (Other Medically Important Condition).; Sender's Comments: V0:20220829623-COVID-19 VACCINE AD26.COV2.S-early-stage rheumatoid arthritis.The event(s) has an unknown/unclear temporal relationship, is unlabeled, and has unknown scientific plausibility. There is no information on any other factors potentially associated with the event(s). Therefore, this event(s) is considered unassessable.
Age: 0.5
Sex: F
Vaccine: COVID19, DTAPIPVHIB, PNC13, RV5, COVID19
Symptoms: Expired product administered, Product storage error
Clinical narrative: The vial was initially stored in the refrigerator on 13-Jul-2022 at 3 pm and vaccine was administered on 15-Aug-2022 around 9:30 pm; No adverse event; Vaccine was administer beyond the used by day; This spontaneous case was reported by a nurse and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Vaccine was administer beyond the used by day), PRODUCT STORAGE ERROR (The vial was initially stored in the refrigerator on 13-Jul-2022 at 3 pm and vaccine was administered on 15-Aug-2022 around 9:30 pm) and NO ADVERSE EVENT (No adverse event) in a 6-month-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. AS1414B) for COVID-19 prophylaxis.     Patient did not had any allergies. It was unknown if patient ever had COVID + test or diagnosis. Patient did not had any acute and chronic illnesses at the time of vaccination. Patient was not given any other vaccines within 1 month prior to Moderna COVID-19 vaccine.     On 15-Aug-2022 at 9:30 PM, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) .25 milliliter. On 15-Aug-2022 at 9:30 PM, the patient experienced EXPIRED PRODUCT ADMINISTERED (Vaccine was administer beyond the used by day). On an unknown date, the patient experienced PRODUCT STORAGE ERROR (The vial was initially stored in the refrigerator on 13-Jul-2022 at 3 pm and vaccine was administered on 15-Aug-2022 around 9:30 pm) and NO ADVERSE EVENT (No adverse event). At the time of the report, EXPIRED PRODUCT ADMINISTERED (Vaccine was administer beyond the used by day), PRODUCT STORAGE ERROR (The vial was initially stored in the refrigerator on 13-Jul-2022 at 3 pm and vaccine was administered on 15-Aug-2022 around 9:30 pm) and NO ADVERSE EVENT (No adverse event) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter considered NO ADVERSE EVENT (No adverse event) to be not related. No further causality assessments were provided for EXPIRED PRODUCT ADMINISTERED (Vaccine was administer beyond the used by day) and PRODUCT STORAGE ERROR (The vial was initially stored in the refrigerator on 13-Jul-2022 at 3 pm and vaccine was administered on 15-Aug-2022 around 9:30 pm).    No concomitant medication information provided. It was reported that patient was not immunocompromised. The vaccine was administered around 9:30 pm. The vial did not undergo any temperature excursions. Patient did not report having side effects. HCP was not aware of incident.  Patient was not on medication according to nurse knowledge. No treatment information provided.   This case was linked to MOD-2022-629215 (E2B Linked Report).; Sender's Comments:  MOD-2022-629215:same reporter , patient 1 case
Age: 0.5
Sex: F
Vaccine: COVID19, DTAPIPVHIB, PNC13, RV5, COVID19
Symptoms: Expired product administered, No adverse event, Product storage error
Clinical narrative: The vial was initially stored in the refrigerator on 13-Jul-2022 at 3 pm and vaccine was administered on 15-Aug-2022 around 9:30 pm; No adverse event; Vaccine was administer beyond the used by day; This spontaneous case was reported by a nurse and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Vaccine was administer beyond the used by day), PRODUCT STORAGE ERROR (The vial was initially stored in the refrigerator on 13-Jul-2022 at 3 pm and vaccine was administered on 15-Aug-2022 around 9:30 pm) and NO ADVERSE EVENT (No adverse event) in a 6-month-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. AS1414B) for COVID-19 prophylaxis.     Patient did not had any allergies. It was unknown if patient ever had COVID + test or diagnosis. Patient did not had any acute and chronic illnesses at the time of vaccination. Patient was not given any other vaccines within 1 month prior to Moderna COVID-19 vaccine.     On 15-Aug-2022 at 9:30 PM, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) .25 milliliter. On 15-Aug-2022 at 9:30 PM, the patient experienced EXPIRED PRODUCT ADMINISTERED (Vaccine was administer beyond the used by day). On an unknown date, the patient experienced PRODUCT STORAGE ERROR (The vial was initially stored in the refrigerator on 13-Jul-2022 at 3 pm and vaccine was administered on 15-Aug-2022 around 9:30 pm) and NO ADVERSE EVENT (No adverse event). At the time of the report, EXPIRED PRODUCT ADMINISTERED (Vaccine was administer beyond the used by day), PRODUCT STORAGE ERROR (The vial was initially stored in the refrigerator on 13-Jul-2022 at 3 pm and vaccine was administered on 15-Aug-2022 around 9:30 pm) and NO ADVERSE EVENT (No adverse event) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter considered NO ADVERSE EVENT (No adverse event) to be not related. No further causality assessments were provided for EXPIRED PRODUCT ADMINISTERED (Vaccine was administer beyond the used by day) and PRODUCT STORAGE ERROR (The vial was initially stored in the refrigerator on 13-Jul-2022 at 3 pm and vaccine was administered on 15-Aug-2022 around 9:30 pm).    No concomitant medication information provided. It was reported that patient was not immunocompromised. The vaccine was administered around 9:30 pm. The vial did not undergo any temperature excursions. Patient did not report having side effects. HCP was not aware of incident.  Patient was not on medication according to nurse knowledge. No treatment information provided.   This case was linked to MOD-2022-629215 (E2B Linked Report).; Sender's Comments:  MOD-2022-629215:same reporter , patient 1 case
Age: 72.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Immunisation reaction, Vaccination site erythema, Vaccination site pain, Vaccination site swelling
Clinical narrative: feeling sick; Ended up getting another injection site reaction on the hip which was 6 inches across and was red in color.; fever; chills; Ended up getting another injection site reaction on the hip which was 6 inches across and was red in color.; This spontaneous case was reported by a patient and describes the occurrence of VACCINATION SITE REACTION (Ended up getting another injection site reaction on the hip which was 6 inches across and was red in color.), MALAISE (feeling sick), VACCINATION SITE ERYTHEMA (Ended up getting another injection site reaction on the hip which was 6 inches across and was red in color.), PYREXIA (fever) and CHILLS (chills) in a 72-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 023M20A and 029L20A) for COVID-19 prophylaxis.     No other vaccines were given within 1 month prior to Moderna COVID-19 vaccine.  The patient's past medical history included Sentinel node biopsy (Sentinel node dissection in the left arm.). Concurrent medical conditions included Diverticulitis (worsening for the last 5 years.). Concomitant products included CALCIUM for an unknown indication.   On 27-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) .5 milliliter. On 24-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to .5 milliliter. On 24-Feb-2021, the patient experienced VACCINATION SITE REACTION (Ended up getting another injection site reaction on the hip which was 6 inches across and was red in color.), VACCINATION SITE ERYTHEMA (Ended up getting another injection site reaction on the hip which was 6 inches across and was red in color.), PYREXIA (fever) and CHILLS (chills). On 25-Feb-2021, the patient experienced MALAISE (feeling sick). On 25-Feb-2021, MALAISE (feeling sick), PYREXIA (fever) and CHILLS (chills) had resolved. At the time of the report, VACCINATION SITE REACTION (Ended up getting another injection site reaction on the hip which was 6 inches across and was red in color.) and VACCINATION SITE ERYTHEMA (Ended up getting another injection site reaction on the hip which was 6 inches across and was red in color.) outcome was unknown.            It was reported that the 2nd dose of the Moderna vaccine on 24-Feb-2021 was given in the hip.  The patient said that patient did not want to receive it in the left arm  as patient had a sentinel node dissection on that side.  Patient reported that the injection site reaction on the hip which was 6 inches across and was red in color had not hurt so much. Fever and chills only lasted overnight. The next morning when patient woke up, patient was feeling sick, but started feeling better with movement. AE had not caused patient to seek medical care. Patient had not experienced a similar event in the past. Patient received Tylenol for side effects related to the vaccine.   This case was linked to MOD-2022-628835, MOD-2022-628840 (Patient Link).
Age: 72.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Chills, Malaise, Pyrexia, Vaccination site erythema, Vaccination site reaction
Clinical narrative: feeling sick; Ended up getting another injection site reaction on the hip which was 6 inches across and was red in color.; fever; chills; Ended up getting another injection site reaction on the hip which was 6 inches across and was red in color.; This spontaneous case was reported by a patient and describes the occurrence of VACCINATION SITE REACTION (Ended up getting another injection site reaction on the hip which was 6 inches across and was red in color.), MALAISE (feeling sick), VACCINATION SITE ERYTHEMA (Ended up getting another injection site reaction on the hip which was 6 inches across and was red in color.), PYREXIA (fever) and CHILLS (chills) in a 72-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 023M20A and 029L20A) for COVID-19 prophylaxis.     No other vaccines were given within 1 month prior to Moderna COVID-19 vaccine.  The patient's past medical history included Sentinel node biopsy (Sentinel node dissection in the left arm.). Concurrent medical conditions included Diverticulitis (worsening for the last 5 years.). Concomitant products included CALCIUM for an unknown indication.   On 27-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) .5 milliliter. On 24-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to .5 milliliter. On 24-Feb-2021, the patient experienced VACCINATION SITE REACTION (Ended up getting another injection site reaction on the hip which was 6 inches across and was red in color.), VACCINATION SITE ERYTHEMA (Ended up getting another injection site reaction on the hip which was 6 inches across and was red in color.), PYREXIA (fever) and CHILLS (chills). On 25-Feb-2021, the patient experienced MALAISE (feeling sick). On 25-Feb-2021, MALAISE (feeling sick), PYREXIA (fever) and CHILLS (chills) had resolved. At the time of the report, VACCINATION SITE REACTION (Ended up getting another injection site reaction on the hip which was 6 inches across and was red in color.) and VACCINATION SITE ERYTHEMA (Ended up getting another injection site reaction on the hip which was 6 inches across and was red in color.) outcome was unknown.            It was reported that the 2nd dose of the Moderna vaccine on 24-Feb-2021 was given in the hip.  The patient said that patient did not want to receive it in the left arm  as patient had a sentinel node dissection on that side.  Patient reported that the injection site reaction on the hip which was 6 inches across and was red in color had not hurt so much. Fever and chills only lasted overnight. The next morning when patient woke up, patient was feeling sick, but started feeling better with movement. AE had not caused patient to seek medical care. Patient had not experienced a similar event in the past. Patient received Tylenol for side effects related to the vaccine.   This case was linked to MOD-2022-628835, MOD-2022-628840 (Patient Link).
Age: 91.0
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, Death, SARS-CoV-2 test positive
Clinical narrative: Death on 8/8/2022
Age: 40.0
Sex: F
Vaccine: COVID19
Symptoms: Chills, Diarrhoea, Fatigue, Lethargy, Malaise
Clinical narrative: Fever of 102, chills, diarrhea, lethargy, malaise. The diarrhea was only one episode about three days after the shot. The fever last two days between 101 and 102 and dropped to between 99 and 100 after the second day, then returned to normal. Fatigue and malaise lasted about 4-5 days.
Age: 40.0
Sex: F
Vaccine: COVID19
Symptoms: Pyrexia
Clinical narrative: Fever of 102, chills, diarrhea, lethargy, malaise. The diarrhea was only one episode about three days after the shot. The fever last two days between 101 and 102 and dropped to between 99 and 100 after the second day, then returned to normal. Fatigue and malaise lasted about 4-5 days.
Age: 5.0
Sex: M
Vaccine: COVID19
Symptoms: Differential white blood cell count, Full blood count, Injection site erythema, Injection site induration, Injection site pruritus
Clinical narrative: Left inguinal lymphadenopathy 8/25/22 Localized red swelling and induration at site of injection on left thigh with itching
Age: 5.0
Sex: M
Vaccine: COVID19
Symptoms: Injection site swelling, Lymphadenopathy
Clinical narrative: Left inguinal lymphadenopathy 8/25/22 Localized red swelling and induration at site of injection on left thigh with itching
Age: 3.0
Sex: M
Vaccine: COVID19
Symptoms: Incorrect dose administered
Clinical narrative: Nurse inadvertently administered Pfizer COVID-19 vaccine product authorized for 5-11 year age population to 3y/o. Nurse also documented the incorrect lot number (Moderna AR9271B) and vaccine type (Pfizer) on the vaccination card and patient consent form. Parent reports no signs/symptoms as of 8/17/22.
Age: 49.0
Sex: F
Vaccine: COVID19
Symptoms: Eczema, Herpes zoster
Clinical narrative: Eczema-like rash on ribcage; shingles rash on chest
Sex: F
Vaccine: COVID19
Symptoms: Blood pressure increased, Blood pressure measurement, Illness, Pain
Clinical narrative: This spontaneous case was reported by a patient and describes the occurrence of ILLNESS (Sick, in bed/ in the bed for 5 or 6 days, kind of nasty), PAIN (after all the vaccines she was in pain) and BLOOD PRESSURE INCREASED (180/ something big blood pressure) in an elderly female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 029L20A and 012220A) for COVID-19 prophylaxis. Concurrent medical conditions included Thyroid disorder NOS (Thyroid), Night terrors, Dry eyes, Anxiety, Pollen allergy (outdoor allergies pollen) and Allergy to plants (Pine trees). Concomitant products included CETIRIZINE for Allergy NOS, SERTRALINE for Anxiety, CICLOSPORIN (RESTASIS) for Dry eyes, LEVOTHYROXINE, ALIROCUMAB (PRALUENT), EZETIMIBE, METOPROLOL SUCCINATE, CLONAZEPAM and MULTIVITAMIN [VITAMINS NOS] for an unknown indication. On 18-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 16-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. In 2021, the patient experienced ILLNESS (Sick, in bed/ in the bed for 5 or 6 days, kind of nasty), PAIN (after all the vaccines she was in pain) and BLOOD PRESSURE INCREASED (180/ something big blood pressure). The patient was treated with APIXABAN (ELIQUIS) at a dose of 5 milligram twice a day. At the time of the report, ILLNESS (Sick, in bed/ in the bed for 5 or 6 days, kind of nasty), PAIN (after all the vaccines she was in pain) and BLOOD PRESSURE INCREASED (180/ something big blood pressure) outcome was unknown. DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, Blood pressure measurement: 180/something big blood pressure. Concomitant medication included Fish gel pills and centrum vitamins everyday. This case was linked to MOD-2022-629219, MOD-2022-629244 (Patient Link). Most recent FOLLOW-UP information incorporated above includes: On 15-Aug-2022: Live follow up received contains non-significant information.
Age: 29.0
Sex: M
Vaccine: SMALLMNK
Symptoms: Rash, Rash pruritic
Clinical narrative: I have a line of rash forming (lichen striatum maybe?) about five inches long on my left arm opposite of my elbow. Just started forming a few days ago and becoming more itchy.