chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 23.0
Sex: F
Vaccine: COVID19
Symptoms: Pharyngeal swelling
Clinical narrative: Pt c/o swelling in her throat, given 25 mg IM Benadryl @ 1543, tolerated well, symptoms improved
Age: 32.0
Sex: F
Vaccine: COVID19
Symptoms: Inappropriate schedule of product administration, No adverse event
Clinical narrative: Patient received the second dose of Moderna before the due date. Patient reported to our office requesting the second dose of Moderna vaccine, said she received a reminder from another clinic that she was due. She did not check her vaccine card or present to our staff until after she received the vaccine. Patient received her first Moderna dose 3/16/21 at pharmacy and her second dose 3/30/21 from our clinic. She had no adverse events, monitored and discharged without incident.
Age: 22.0
Sex: F
Vaccine: COVID19
Symptoms: Hypoaesthesia, Oedema peripheral, Paraesthesia
Clinical narrative: R arm edema R hand edema R hand numbness/tingling
Age: 53.0
Sex: F
Vaccine: COVID19
Symptoms: Dyspnoea, Hypoaesthesia oral, Paraesthesia oral, Pharyngeal swelling
Clinical narrative: About 10 minutes after receiving their 1st COVID shot, patient reported to pharmacy staff that they felt like their tongue was numb and tingling. Patient then spoke to the pharmacist and they stated they also felt like their throat was swollen and were given Benadryl 25mg. Staff called 911 and pharmacist administered an Epi-pen after patient stated they had difficulty breathing, felt like their throat, and tongue was swelling. Pharmacist waited with patient until EMTs arrived where they then took the patient under their care. EMTs did not indicate they were sending patient to nearby Emergency Room to pharmacy staff. (Continued on continuation page) Patient was apprehensive about going to the ED; EMTs said they would first monitor patient and decide if they'd go to ED or not. Pharmacist called local ED to see if patient was admitted around 5:30pm that day. Per ED staff, patient was not admitted. Tried calling patient later that day and the next day as well but no answer
Age: 58.0
Sex: F
Vaccine: COVID19
Symptoms: Capillary nail refill test, Hypoaesthesia
Clinical narrative: Patient c/o numbness over right arm approximately 10 min s/p injection. Patient had good pulses, capillary refill, and No cyanosis or skin color changes.  She had similar reaction to the zoster vaccine in the past.
Sex: F
Vaccine: COVID19
Symptoms: Cough, Taste disorder, Throat clearing, Throat irritation
Clinical narrative: 1040A Rec'd vaccine, walked to waiting room, put purse down, went to bathroom, then sat down. Felt throat scratchy, then need to cough, clear throat, tasted "medicine" in mouth. 11:00A 50mg po Benadryl, had patient wait 30 minutes, then 15 more minutes (next page).
Age: 85.0
Sex: U
Vaccine: COVID19, COVID19
Symptoms: C-reactive protein, Fibrin D dimer, Injection site pain, Joint swelling, Oedema peripheral
Clinical narrative: 1st shot no issues except injection pain. 2nd shot ok by awakened with swelling left hand/ wrist- weak after. Left arm pain as well.
Age: 85.0
Sex: U
Vaccine: COVID19, COVID19
Symptoms: Peripheral swelling, Sleep disorder
Clinical narrative: 1st shot no issues except injection pain. 2nd shot ok by awakened with swelling left hand/ wrist- weak after. Left arm pain as well.
Age: 69.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Wheezing
Clinical narrative: I had sent in my first report after my 1st vaccine and hope you received it by certified mail.  The blood work done after my 1st vaccine showed an elevated liver count.  The test was redone 03-23-21, and the liver count is normal.    My right arm started to hurt around 7:00 pm after getting the 2nd vaccine  shot between 11-12 am 3/26/21.  There had been no vaccine 3-25-21, so I was called to come in , and I said I'd be there as the same time before .  Due to minor swelling and continued pain, initially heat helped and then to a cold compress .  I took 1 Tylenol, as I had began slight headache.  During the (night or) early morning around 2:00 am , I awoke chilled to the bone until around 4:30 am. I stayed in bed  Saturday morning  (the 37th of March until 11: am due to my body being achey, weak, foggy brain,  left side of my kidney hurt, noticed I was urinating less the next few days, my upper stomach to the left middle throbbed/ached, had weak muscles and bone, with a stiff neck, as my whole body felt I had been run over by a truck.  At 5 pm the same day (3-37-21) I felt faint, just as weak or weaker with kidney (left side) continued to hurt, as well as, the upper part of my stomach (middle) and under my breastbone.  I stayed in bed all day Sunday, 03-28-21   My bowels have been affected - off + on. (03-29-2021)  Because of the Emergency Care visits and test ,  my family dr. wanted me to come in. She was sort of dismissive about there being anything to do when on gets the covid-19 virus.           The Emergency Care Dr. (Privacy) went over symptoms, gave me 4 pages of information and had done the blood work, strep test because my throat seemed like it was blistering,  my chest hurt and with a lot of coughin.  for weeks,  he did a chest x-ray.  After 5 covid test and all coming back negative , the blood work showed I had had the virus but my antibodies due to my low immune system , tried to fight it off. The dr says I'll be one of the Long Haulers , so I do not know what symptoms  I'll have to come. I just feel tired and listless with all of this going on with my whole body system. Continues where I had gotten my inhaler filled (never had to ever use it after 10 years of allergy shots - everyone here seems to have allergies but over the years I have not been affected until after the 1st shot.)  I only heard a little wheezing at night at bedtime and sleep on 2 pillows for elevation and due to acid reflux.     My kidneys and bowels continue to be affected. The fibromyalgia 1 nervous system had affected both. Now, the kidneys go to much or not enough, and my bowles are constipation to much diarreah.     (3-30-21)  Woke up and just not feeling well all over. I am a optimistic person and do well in public or during this pandemic.  I always find much to do around the house, but it takes me days to do a single task.  I do crossword puzzles daily to keep mentally active. I walk around my yard and pull a few weeds,  plant a flower or two, but know my body well to know the symptoms will be around as a LONG HAULER. Thanks.
Age: 50.0
Sex: M
Vaccine: COVID19
Symptoms: Fatigue, Headache
Clinical narrative: FATIGUE, HEADACHE RESOLVED IN 12  HOURS Narrative:
Age: 90.0
Sex: M
Vaccine: COVID19
Symptoms: Fatigue
Clinical narrative: fatigue Narrative:
Age: 72.0
Sex: M
Vaccine: COVID19
Symptoms: Arthralgia, Muscular weakness, Myalgia
Clinical narrative: weakness in legs sore muscles and joints Narrative:
Age: 35.0
Sex: M
Vaccine: COVID19
Symptoms: COVID-19, SARS-CoV-2 test positive
Clinical narrative: Positive COVID PCR Narrative:
Age: 78.0
Sex: M
Vaccine: COVID19
Symptoms: Asthenia, Gait inability
Clinical narrative: weak couldnt walk Narrative:
Age: 60.0
Sex: M
Vaccine: COVID19
Symptoms: Injection site pain
Clinical narrative: soreness at inj site Narrative:
Age: 84.0
Sex: M
Vaccine: COVID19
Symptoms: Hypoaesthesia, Magnetic resonance imaging
Clinical narrative: numbness and loss of muscle control in right wrist and fingers. Narrative: Patient obtained MRI to rule out possible stroke is receiving care with Physical Therapy, Occupational Therapy and Neurology.
Age: 53.0
Sex: M
Vaccine: COVID19
Symptoms: Amylase normal, Full blood count normal, Liver function test normal, Renal function test normal, SARS-CoV-2 test negative
Clinical narrative: Narrative:
Age: 53.0
Sex: M
Vaccine: COVID19
Symptoms: Unevaluable event
Clinical narrative: Narrative:
Age: 76.0
Sex: M
Vaccine: COVID19
Symptoms: Nasopharyngitis
Clinical narrative: head cold Narrative:
Age: 55.0
Sex: F
Vaccine: COVID19
Symptoms: Dysgeusia, Hypoaesthesia oral, Injection site pain, Muscle strain, Neck pain
Clinical narrative: metallic taste in mouth, lip numbness, injection site pain, tingling in fingers, neck pain or strain Narrative: RN asked to assess patient in post vaccination observation area. Patient c/o metallic taste in mouth, lip numbness, left upper arm pain (injection site), left fingers tingling, neck (trapezius muscle) pain or strain. Denies SOB, chest pain, difficulty breathing or swallowing, drinking fluids without difficulty. Denies air hunger or throat swelling, no rash observed or itching. Alert and oriented. Skin pink warm and dry. Symptoms subsided at 9:20. Attending provider plans to contact patient to discuss second vaccine dose. Patient declined further work up in ER. At 9:45 denies metallic taste or lip numbness. States "maybe I am overthinking this, I am feeling better." No neck or finger issues, slight tenderness at injection site, no rash, SOB, throat swelling or chest pain. Discharged to home at 9:50 in stable condition.
Age: 55.0
Sex: F
Vaccine: COVID19
Symptoms: Paraesthesia
Clinical narrative: metallic taste in mouth, lip numbness, injection site pain, tingling in fingers, neck pain or strain Narrative: RN asked to assess patient in post vaccination observation area. Patient c/o metallic taste in mouth, lip numbness, left upper arm pain (injection site), left fingers tingling, neck (trapezius muscle) pain or strain. Denies SOB, chest pain, difficulty breathing or swallowing, drinking fluids without difficulty. Denies air hunger or throat swelling, no rash observed or itching. Alert and oriented. Skin pink warm and dry. Symptoms subsided at 9:20. Attending provider plans to contact patient to discuss second vaccine dose. Patient declined further work up in ER. At 9:45 denies metallic taste or lip numbness. States "maybe I am overthinking this, I am feeling better." No neck or finger issues, slight tenderness at injection site, no rash, SOB, throat swelling or chest pain. Discharged to home at 9:50 in stable condition.
Age: 42.0
Sex: M
Vaccine: COVID19
Symptoms: Presyncope
Clinical narrative: Vasovagal response, responded to fluids and food. VSS after observe for 30 min. Narrative:
Age: 65.0
Sex: M
Vaccine: COVID19
Symptoms: Muscle tightness
Clinical narrative: tightness in both arms Narrative:
Age: 62.0
Sex: M
Vaccine: COVID19
Symptoms: Asthenia, Dizziness, Sensory disturbance
Clinical narrative: "Weak, Wants to pass out, needle phobia, feel weird in chest" Narrative:
Age: 59.0
Sex: F
Vaccine: COVID19
Symptoms: Pain in extremity, Peripheral swelling
Clinical narrative: significant arm swelling and pain Narrative:
Age: 28.0
Sex: M
Vaccine: COVID19
Symptoms: Chills, Fatigue, Pain, Pyrexia
Clinical narrative: chills,fatigue, body aches and fever Narrative:
Age: 63.0
Sex: M
Vaccine: COVID19
Symptoms: Chills, Fatigue, Injection site pruritus, Injection site rash, Nausea
Clinical narrative: fatigue/chills Narrative: She developed a pruritic rash, chills, fatigue, and nausea after the initial vaccination: *Pruritic rash: started ~6-7 hours after the vaccination. Initially localized to "small" area around injection site (not able to provide reference for size), noted it was well-circumscribed at the time and not warm to touch or indurated. This lasted for about 2x days and relief of itching a/w OTC topical bendaryl. *Chills/fatigue/nausea: all described as mild, started evening of vaccination and spontaneous resolving after about a day. No therapies were tried or applied.
Age: 63.0
Sex: M
Vaccine: COVID19
Symptoms: Rash pruritic
Clinical narrative: fatigue/chills Narrative: She developed a pruritic rash, chills, fatigue, and nausea after the initial vaccination: *Pruritic rash: started ~6-7 hours after the vaccination. Initially localized to "small" area around injection site (not able to provide reference for size), noted it was well-circumscribed at the time and not warm to touch or indurated. This lasted for about 2x days and relief of itching a/w OTC topical bendaryl. *Chills/fatigue/nausea: all described as mild, started evening of vaccination and spontaneous resolving after about a day. No therapies were tried or applied.
Age: 38.0
Sex: M
Vaccine: COVID19
Symptoms: Chills
Clinical narrative: Chills Narrative:
Age: 30.0
Sex: M
Vaccine: COVID19
Symptoms: Fatigue, Oropharyngeal pain, Pain
Clinical narrative: body aches,sore throat, fatigue Narrative: Pt presents with symptoms of mild sore throat for 4 days with fatigue. He had received his first dose of Moderna COVID-19 vaccine 1 week ago and was wondering if his symptoms were related to this. He did develop initial body aches for a couple of days but the sore throat and fatigue came later. He denies any fevers, chills, sweats, diarrhea, loss of taste or smell, rash, cognitive deficits. He also has a history of allergic rhinitis and has not been taking his antihistamines and was wondering if the fatigue and sore throat could be related to this also. Since booking his appointments, his symptoms have improved today.
Age: 84.0
Sex: M
Vaccine: COVID19
Symptoms: Injection site pain
Clinical narrative: sore at inj site Narrative:
Age: 69.0
Sex: M
Vaccine: COVID19
Symptoms: COVID-19, Respiratory disorder, SARS-CoV-2 test positive
Clinical narrative: positive covid test Narrative: ED visit for respiratory issues, found to be covid positive but not likely due to covid sx- other likely explanations.
Age: 75.0
Sex: M
Vaccine: COVID19
Symptoms: Deafness unilateral, Hypoacusis
Clinical narrative: LOSS/CHANGE OF HEARING IN THE LEFT EAR FOLLOWING HIS SECOND COVID VACCINE Narrative:
Age: 66.0
Sex: M
Vaccine: COVID19
Symptoms: Dyskinesia, Jaw disorder, Magnetic resonance imaging head abnormal, Memory impairment, Tongue movement disturbance
Clinical narrative: involuntary movements of the mouth, jaw, and tongue Narrative: Pt had 2nd COVID SHOT ON 3/10/21. A few days later he started having involuntary movements of the mouth and jaw-jutting out jaw and moving tongue back and forth. Potential causes/confounding factors: - Patient is taking risperdal (wife confirms patient is taking) - Per patient's wife, 3-4 years ago patient saw neurologist because patient was having memory problems and making comments in conversation that did not make sense. Head MRI showed Patient had "more white matter then he should and some lesions." Patient and wife were it could be early signs of Parkinson's or MS. Neurology an Psychiatry consulted, Head CT orders, Records being requested from previous neurologist.
Age: 66.0
Sex: M
Vaccine: COVID19
Symptoms: White matter lesion
Clinical narrative: involuntary movements of the mouth, jaw, and tongue Narrative: Pt had 2nd COVID SHOT ON 3/10/21. A few days later he started having involuntary movements of the mouth and jaw-jutting out jaw and moving tongue back and forth. Potential causes/confounding factors: - Patient is taking risperdal (wife confirms patient is taking) - Per patient's wife, 3-4 years ago patient saw neurologist because patient was having memory problems and making comments in conversation that did not make sense. Head MRI showed Patient had "more white matter then he should and some lesions." Patient and wife were it could be early signs of Parkinson's or MS. Neurology an Psychiatry consulted, Head CT orders, Records being requested from previous neurologist.
Age: 73.0
Sex: M
Vaccine: COVID19
Symptoms: Asymptomatic COVID-19, SARS-CoV-2 test positive
Clinical narrative: positive covid test- outide test - 3/27/2021 Narrative: asymptomatic but covid postiive test
Age: 30.0
Sex: F
Vaccine: COVID19
Symptoms: Lymphadenopathy, Myalgia, Peripheral swelling
Clinical narrative: Myalgia lymphadenapathy cervical, selling left arm. Narrative:  Other Relevant History:
Age: 75.0
Sex: M
Vaccine: COVID19
Symptoms: Injection site pruritus
Clinical narrative: Narrative: Patient reported developing itching a site of injection about 5 days after vaccine.
Age: 63.0
Sex: F
Vaccine: COVID19
Symptoms: Chills, Fatigue
Clinical narrative: fatigue and chills Narrative:
Age: 79.0
Sex: M
Vaccine: COVID19
Symptoms: Blood urine present
Clinical narrative: blood in urine Narrative:
Age: 26.0
Sex: F
Vaccine: COVID19
Symptoms: Arthralgia, Loss of personal independence in daily activities
Clinical narrative: Narrative: 25 yo F that received dose #1 of the Moderna COVID-19 vaccine on 3/10/2021 (Lot#: 026A21A; Exp Date: 8/26/2021) around 08:30. Pt contacted Facility on 3/30/2021 to report symptoms following vaccination. Pt reports arthralgia starting later that day following vaccination in her hands (fingers, wrists), knees, and feet (toes, ankles). Pt also reports pain in shoulders and elbows bilaterally. Pain is constant 8/10, denies swelling or redness of joints. Denies fever/chills. Adverse effects interfering with her ADL's. Pt has been taking OTC NSAID (ibuprofen 800mg) as directed based on package label. Following assessment by provider, recommend continuation of OTC NSAID in addition to OTC acetaminophen. Reaction classified as moderate as intervention/treatment recommended.
Age: 80.0
Sex: F
Vaccine: COVID19
Symptoms: General symptom, Incomplete course of vaccination
Clinical narrative: Narrative: Patient denied any current signs/symtoms, said all side effects resolved. She never sought any emergency evaluation or treatment and denied need for evaluation/treatment today. Patient just decline to receive 2nd dose of Moderna Covid-19 vaccine.
Age: 69.0
Sex: M
Vaccine: COVID19
Symptoms: Peripheral swelling
Clinical narrative: swelling in arm Narrative:
Age: 60.0
Sex: M
Vaccine: COVID19
Symptoms: COVID-19, Diarrhoea, Exposure to SARS-CoV-2, Fatigue, Headache
Clinical narrative: fatigue Narrative:  Patient called COVID-19 vaccine adverse event hotline to report experiencing diarrhea, light headache, and fatigue as a result of the second dose of the Pfizer COVID vaccine. The patient is since feeling better, but reports testing positive for COVID-19 (he got tested after being exposed to members of his household who tested positive) on 3/31/2021. The patient is self-isolating and feeling well. He states he will reach out to his primary care provider for further instructions.
Age: 60.0
Sex: M
Vaccine: COVID19
Symptoms: SARS-CoV-2 test positive
Clinical narrative: fatigue Narrative:  Patient called COVID-19 vaccine adverse event hotline to report experiencing diarrhea, light headache, and fatigue as a result of the second dose of the Pfizer COVID vaccine. The patient is since feeling better, but reports testing positive for COVID-19 (he got tested after being exposed to members of his household who tested positive) on 3/31/2021. The patient is self-isolating and feeling well. He states he will reach out to his primary care provider for further instructions.
Age: 60.0
Sex: M
Vaccine: COVID19
Symptoms: Lymphadenopathy, Pain in extremity
Clinical narrative: Swelling of lymphnode on left armpit , resolved by itself after 4 days, along with left sore arm. Narrative:
Age: 77.0
Sex: M
Vaccine: COVID19
Symptoms: Abdominal pain upper, Acute kidney injury, Ascites, Asthenia, Back pain
Clinical narrative: No vaccine related ADR reported Narrative: A 76yo male with history of HTN, DM, BPH, HLD, Orthostatic Hypotension, Neuroendocrine Tumor of Liver consistent w/ small Cell Carcinoma and Biliary obstruction per ED admission history, he had percutaneous Cholecystectomy and stent placement on December 30, 2020 and subsequent necrotizing fasciitis of R. chest / flank around tube s/p debridement and biliary stent placement received Pfizer's Covid-19 vaccine on February 6, 2021 He presented to ED on February 24, 2021 with complaint of weakness and back pain. ED documents included the patient denied Fever, N/V/D, Constipation or SOB. The patient's wife was there to five additional history and reported "he has had decreased appetite for the last month and increased weakness for the last few days" He was admitted with CT finding concerning for multiple liver abscess. He was started on zosyn and vancomycin for sepsis pending blood and liver abscess cultures. Vanco was discontinued on Feb 25. Blood culture result on February 26, confirmed presence of gm- ve Rods. He had R. liver robe aspiration on Feb 27 On Feb 28, he complained of uppder quadrant abdominal pain, also had low appetite. He was placed on isolation which was confirmed from the liver abscess/aspiration culture He had pending resolution of sepsis for staging his cancer and starting palliative chemotherapy. Developed AKI while undergoing treatment, had biliary obstruction and cholecystectomy, developed new neurological symptoms, ascites and had malignancy with multiple organ dysfunction leading to poor prognosis. Per nursing immunization note on February 6, 2021, the day he received Covid-19 vaccine, it was administered without complications, per policy and protocol. Also the patient was provided with information regarding side effect of the vaccine how to report ADR and advised to stay in the facility for 15 minutes after the vaccine was administered There were no vaccine ADRs reported in the notes The patient was status biliary stent on March 4, 2021 in palliative care and passed away on March 8, 2021.
Age: 77.0
Sex: M
Vaccine: COVID19
Symptoms: Biopsy liver abnormal, Blood culture positive, Chemotherapy, Computerised tomogram abdomen abnormal, Culture
Clinical narrative: No vaccine related ADR reported Narrative: A 76yo male with history of HTN, DM, BPH, HLD, Orthostatic Hypotension, Neuroendocrine Tumor of Liver consistent w/ small Cell Carcinoma and Biliary obstruction per ED admission history, he had percutaneous Cholecystectomy and stent placement on December 30, 2020 and subsequent necrotizing fasciitis of R. chest / flank around tube s/p debridement and biliary stent placement received Pfizer's Covid-19 vaccine on February 6, 2021 He presented to ED on February 24, 2021 with complaint of weakness and back pain. ED documents included the patient denied Fever, N/V/D, Constipation or SOB. The patient's wife was there to five additional history and reported "he has had decreased appetite for the last month and increased weakness for the last few days" He was admitted with CT finding concerning for multiple liver abscess. He was started on zosyn and vancomycin for sepsis pending blood and liver abscess cultures. Vanco was discontinued on Feb 25. Blood culture result on February 26, confirmed presence of gm- ve Rods. He had R. liver robe aspiration on Feb 27 On Feb 28, he complained of uppder quadrant abdominal pain, also had low appetite. He was placed on isolation which was confirmed from the liver abscess/aspiration culture He had pending resolution of sepsis for staging his cancer and starting palliative chemotherapy. Developed AKI while undergoing treatment, had biliary obstruction and cholecystectomy, developed new neurological symptoms, ascites and had malignancy with multiple organ dysfunction leading to poor prognosis. Per nursing immunization note on February 6, 2021, the day he received Covid-19 vaccine, it was administered without complications, per policy and protocol. Also the patient was provided with information regarding side effect of the vaccine how to report ADR and advised to stay in the facility for 15 minutes after the vaccine was administered There were no vaccine ADRs reported in the notes The patient was status biliary stent on March 4, 2021 in palliative care and passed away on March 8, 2021.
Age: 77.0
Sex: M
Vaccine: COVID19
Symptoms: Death, Decreased appetite, Hepatic cancer, Multiple organ dysfunction syndrome, Neurological symptom
Clinical narrative: No vaccine related ADR reported Narrative: A 76yo male with history of HTN, DM, BPH, HLD, Orthostatic Hypotension, Neuroendocrine Tumor of Liver consistent w/ small Cell Carcinoma and Biliary obstruction per ED admission history, he had percutaneous Cholecystectomy and stent placement on December 30, 2020 and subsequent necrotizing fasciitis of R. chest / flank around tube s/p debridement and biliary stent placement received Pfizer's Covid-19 vaccine on February 6, 2021 He presented to ED on February 24, 2021 with complaint of weakness and back pain. ED documents included the patient denied Fever, N/V/D, Constipation or SOB. The patient's wife was there to five additional history and reported "he has had decreased appetite for the last month and increased weakness for the last few days" He was admitted with CT finding concerning for multiple liver abscess. He was started on zosyn and vancomycin for sepsis pending blood and liver abscess cultures. Vanco was discontinued on Feb 25. Blood culture result on February 26, confirmed presence of gm- ve Rods. He had R. liver robe aspiration on Feb 27 On Feb 28, he complained of uppder quadrant abdominal pain, also had low appetite. He was placed on isolation which was confirmed from the liver abscess/aspiration culture He had pending resolution of sepsis for staging his cancer and starting palliative chemotherapy. Developed AKI while undergoing treatment, had biliary obstruction and cholecystectomy, developed new neurological symptoms, ascites and had malignancy with multiple organ dysfunction leading to poor prognosis. Per nursing immunization note on February 6, 2021, the day he received Covid-19 vaccine, it was administered without complications, per policy and protocol. Also the patient was provided with information regarding side effect of the vaccine how to report ADR and advised to stay in the facility for 15 minutes after the vaccine was administered There were no vaccine ADRs reported in the notes The patient was status biliary stent on March 4, 2021 in palliative care and passed away on March 8, 2021.
Age: 77.0
Sex: M
Vaccine: COVID19
Symptoms: Sepsis
Clinical narrative: No vaccine related ADR reported Narrative: A 76yo male with history of HTN, DM, BPH, HLD, Orthostatic Hypotension, Neuroendocrine Tumor of Liver consistent w/ small Cell Carcinoma and Biliary obstruction per ED admission history, he had percutaneous Cholecystectomy and stent placement on December 30, 2020 and subsequent necrotizing fasciitis of R. chest / flank around tube s/p debridement and biliary stent placement received Pfizer's Covid-19 vaccine on February 6, 2021 He presented to ED on February 24, 2021 with complaint of weakness and back pain. ED documents included the patient denied Fever, N/V/D, Constipation or SOB. The patient's wife was there to five additional history and reported "he has had decreased appetite for the last month and increased weakness for the last few days" He was admitted with CT finding concerning for multiple liver abscess. He was started on zosyn and vancomycin for sepsis pending blood and liver abscess cultures. Vanco was discontinued on Feb 25. Blood culture result on February 26, confirmed presence of gm- ve Rods. He had R. liver robe aspiration on Feb 27 On Feb 28, he complained of uppder quadrant abdominal pain, also had low appetite. He was placed on isolation which was confirmed from the liver abscess/aspiration culture He had pending resolution of sepsis for staging his cancer and starting palliative chemotherapy. Developed AKI while undergoing treatment, had biliary obstruction and cholecystectomy, developed new neurological symptoms, ascites and had malignancy with multiple organ dysfunction leading to poor prognosis. Per nursing immunization note on February 6, 2021, the day he received Covid-19 vaccine, it was administered without complications, per policy and protocol. Also the patient was provided with information regarding side effect of the vaccine how to report ADR and advised to stay in the facility for 15 minutes after the vaccine was administered There were no vaccine ADRs reported in the notes The patient was status biliary stent on March 4, 2021 in palliative care and passed away on March 8, 2021.
Age: 61.0
Sex: M
Vaccine: COVID19
Symptoms: Chills, Feeling abnormal, Mobility decreased, Pyrexia
Clinical narrative: "chills, fever, and felt like he was paralyzed, stating he couldn't get up out of bed" Narrative:
Age: 72.0
Sex: M
Vaccine: COVID19
Symptoms: Asthenia, Dizziness, Fatigue, Feeling abnormal, Headache
Clinical narrative: Nausea, head aches-various, sore throat, tiredness, long sleeps, no energy, lightheadedness, aching muscles. Tylenol & Benadryl. Both my wife & I had the vaccination at the same time, became ill at same time and we had the flu for 3 weeks as it tapered off to feel normal again. We both got our 2nd Moderna vaccination on March 9, 2021 at 10:30 A.M. and the next day flu set in the same as the first time but this tapered off in a week when we felt normal again. The first episode we almost went to the emergency room due to the flu effects.
Age: 72.0
Sex: M
Vaccine: COVID19
Symptoms: Hypersomnia, Influenza, Malaise, Myalgia, Nausea
Clinical narrative: Nausea, head aches-various, sore throat, tiredness, long sleeps, no energy, lightheadedness, aching muscles. Tylenol & Benadryl. Both my wife & I had the vaccination at the same time, became ill at same time and we had the flu for 3 weeks as it tapered off to feel normal again. We both got our 2nd Moderna vaccination on March 9, 2021 at 10:30 A.M. and the next day flu set in the same as the first time but this tapered off in a week when we felt normal again. The first episode we almost went to the emergency room due to the flu effects.
Age: 72.0
Sex: M
Vaccine: COVID19
Symptoms: Oropharyngeal pain
Clinical narrative: Nausea, head aches-various, sore throat, tiredness, long sleeps, no energy, lightheadedness, aching muscles. Tylenol & Benadryl. Both my wife & I had the vaccination at the same time, became ill at same time and we had the flu for 3 weeks as it tapered off to feel normal again. We both got our 2nd Moderna vaccination on March 9, 2021 at 10:30 A.M. and the next day flu set in the same as the first time but this tapered off in a week when we felt normal again. The first episode we almost went to the emergency room due to the flu effects.
Age: 94.0
Sex: F
Vaccine: COVID19
Symptoms: Blood magnesium decreased, Blood sodium decreased, Blood test abnormal, Fatigue, Heart rate increased
Clinical narrative: Noticed slight swelling in left arm at injection site on March 18. Intermittent rapid pulse (129) was detected on March 23, 2021. Doctor was contacted and telehealth appointment held n March 29th. Home Health nurse came on March 30th, gave patient an exam, and drew blood for testing. Checked for symptoms and only apparent one (other than irregular pulse) was fatigue. Home health aid visited again on April 2, examined patient and found pulse to still be irregular but lower (60s). Patient still only exhibited fatigue. Blood test results showed excellent kidney function, but lower than normal sodium levels (133) and lower than normal (1.4) magnesium levels. Dr. recommended increasing salt intake and magnesium supplement. Dr. advised
Age: 94.0
Sex: F
Vaccine: COVID19
Symptoms: Heart rate irregular, Injection site swelling
Clinical narrative: Noticed slight swelling in left arm at injection site on March 18. Intermittent rapid pulse (129) was detected on March 23, 2021. Doctor was contacted and telehealth appointment held n March 29th. Home Health nurse came on March 30th, gave patient an exam, and drew blood for testing. Checked for symptoms and only apparent one (other than irregular pulse) was fatigue. Home health aid visited again on April 2, examined patient and found pulse to still be irregular but lower (60s). Patient still only exhibited fatigue. Blood test results showed excellent kidney function, but lower than normal sodium levels (133) and lower than normal (1.4) magnesium levels. Dr. recommended increasing salt intake and magnesium supplement. Dr. advised
Age: 66.0
Sex: M
Vaccine: COVID19, COVID19, COVID19, COVID19
Symptoms: Asthenia, Decreased appetite, Vomiting
Clinical narrative: Vomiting; This is a spontaneous case received from a contactable Pharmacist. A 66-years-old male patient received the second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EL3248), intramuscular, administered in left deltoid on 03Feb2021 at14:00 (the age of 66-years-old) as a single dose for COVID-19 immunisation. Medical history included neoplasm malignant from an unknown date and unknown if ongoing and chemotherapy from an unknown date and unknown if ongoing. The patient's concomitant medications were not reported. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient previously received the first dose of BNT162b2 on 15Jan2021 at 13:28 in the left deltoid for COVID-19 immunisation. On 05Feb2021 at 04:00, after the second vaccination, the patient experienced vomiting. Patient thought the vomiting could be in part to chemotherapy he had; the last treatment was about 2 months before his first dose of the vaccine. No admission to the hospital was required due to the event. COVID-19 vaccine was accidently mixed with sterile water for injection instead of Sodium chloride 0.9% for injection. Error was made in part of education for diluent use. Clinical outcome of the event vomiting was recovered.
Age: 66.0
Sex: M
Vaccine: COVID19, COVID19, COVID19, COVID19
Symptoms: Vomiting
Clinical narrative: Vomiting; This is a spontaneous case received from a contactable Pharmacist. A 66-years-old male patient received the second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EL3248), intramuscular, administered in left deltoid on 03Feb2021 at14:00 (the age of 66-years-old) as a single dose for COVID-19 immunisation. Medical history included neoplasm malignant from an unknown date and unknown if ongoing and chemotherapy from an unknown date and unknown if ongoing. The patient's concomitant medications were not reported. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient previously received the first dose of BNT162b2 on 15Jan2021 at 13:28 in the left deltoid for COVID-19 immunisation. On 05Feb2021 at 04:00, after the second vaccination, the patient experienced vomiting. Patient thought the vomiting could be in part to chemotherapy he had; the last treatment was about 2 months before his first dose of the vaccine. No admission to the hospital was required due to the event. COVID-19 vaccine was accidently mixed with sterile water for injection instead of Sodium chloride 0.9% for injection. Error was made in part of education for diluent use. Clinical outcome of the event vomiting was recovered.
Age: 66.0
Sex: M
Vaccine: COVID19, COVID19, COVID19, COVID19
Symptoms: Product preparation error, Vomiting
Clinical narrative: Vomiting; This is a spontaneous case received from a contactable Pharmacist. A 66-years-old male patient received the second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EL3248), intramuscular, administered in left deltoid on 03Feb2021 at14:00 (the age of 66-years-old) as a single dose for COVID-19 immunisation. Medical history included neoplasm malignant from an unknown date and unknown if ongoing and chemotherapy from an unknown date and unknown if ongoing. The patient's concomitant medications were not reported. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient previously received the first dose of BNT162b2 on 15Jan2021 at 13:28 in the left deltoid for COVID-19 immunisation. On 05Feb2021 at 04:00, after the second vaccination, the patient experienced vomiting. Patient thought the vomiting could be in part to chemotherapy he had; the last treatment was about 2 months before his first dose of the vaccine. No admission to the hospital was required due to the event. COVID-19 vaccine was accidently mixed with sterile water for injection instead of Sodium chloride 0.9% for injection. Error was made in part of education for diluent use. Clinical outcome of the event vomiting was recovered.
Age: 70.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Unevaluable event
Clinical narrative: light headache; site pain morning after; This is a spontaneous report from a contactable other healthcare professional reported for herself. A 70-year-old non-pregnant female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Solution for injection, Lot number: EN5318), at 70 years of age, via an unspecified route of administration on 07Feb2021 03:45 at single dose, in left arm for COVID-19 immunization. The patient medical history included Multiple sclerosis and unknown if ongoing. Patient had an statins allergy. Concomitant medication included gabapentin, Prozac, gemfibrozil,  losartan and coq10. On 07Feb2021: 07:00 PM, the patient experienced light headache and site pain. The events were considered as non-serious. No treatment was given for the events. Patient did not diagnosed with COVID-19 prior to vaccination. Since the vaccination, the patient had not been tested for COVID-19. The outcome of events was recovered on an unknown date.
Age: 70.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Headache, Vaccination site pain
Clinical narrative: light headache; site pain morning after; This is a spontaneous report from a contactable other healthcare professional reported for herself. A 70-year-old non-pregnant female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Solution for injection, Lot number: EN5318), at 70 years of age, via an unspecified route of administration on 07Feb2021 03:45 at single dose, in left arm for COVID-19 immunization. The patient medical history included Multiple sclerosis and unknown if ongoing. Patient had an statins allergy. Concomitant medication included gabapentin, Prozac, gemfibrozil,  losartan and coq10. On 07Feb2021: 07:00 PM, the patient experienced light headache and site pain. The events were considered as non-serious. No treatment was given for the events. Patient did not diagnosed with COVID-19 prior to vaccination. Since the vaccination, the patient had not been tested for COVID-19. The outcome of events was recovered on an unknown date.
Age: 80.0
Sex: U
Vaccine: COVID19, COVID19
Symptoms: Diarrhoea, Fatigue, Headache, Illness, Myalgia
Clinical narrative: chills; fever; fatigue; This is a spontaneous report from a contactable consumer (patient). The consumer reported similar event in two dosage. This is the second of two reports. An 80-year-old patient of an unspecified gender received second dose bnt162b2 (BNT162B2), via an unspecified route of administration, administered in Arm Left on an unspecified date (Lot Number: EL6201) as SINGLE DOSE for covid-19 immunisation.  Medical history included diagnosed allergies, compromised immune status, respiratory illness, diabetes, obesity.  The patient's concomitant medications included Regular meds and Xylenol.  The patient previously received first dose bnt162b2 (Lot number EL3302) on 20Jan2021 for covid-19 immunization and experienced sudden tiredness, Fleeting mild headaches in recovery, Nausea, Fierce diarrhea, Very sick for two hours, Muscle aches instead still there, Vomited.  The patient experienced chills, fever and, fatigue on an unspecified date. Time of onset was 8 am next day. Adverse events did not require visit to Emergency room and visit to Physician office. Th patient did not receive event prior Vaccinations(Within 4 weeks). Relevant test was reported to be too many to list.  The outcome of the event was unknown.; Sender's Comments: Linked Report(s) : US-PFIZER INC-2021092042 same patient, same drug, similar event, different dose separated in times
Age: 80.0
Sex: U
Vaccine: COVID19, COVID19
Symptoms: Nausea
Clinical narrative: chills; fever; fatigue; This is a spontaneous report from a contactable consumer (patient). The consumer reported similar event in two dosage. This is the second of two reports. An 80-year-old patient of an unspecified gender received second dose bnt162b2 (BNT162B2), via an unspecified route of administration, administered in Arm Left on an unspecified date (Lot Number: EL6201) as SINGLE DOSE for covid-19 immunisation.  Medical history included diagnosed allergies, compromised immune status, respiratory illness, diabetes, obesity.  The patient's concomitant medications included Regular meds and Xylenol.  The patient previously received first dose bnt162b2 (Lot number EL3302) on 20Jan2021 for covid-19 immunization and experienced sudden tiredness, Fleeting mild headaches in recovery, Nausea, Fierce diarrhea, Very sick for two hours, Muscle aches instead still there, Vomited.  The patient experienced chills, fever and, fatigue on an unspecified date. Time of onset was 8 am next day. Adverse events did not require visit to Emergency room and visit to Physician office. Th patient did not receive event prior Vaccinations(Within 4 weeks). Relevant test was reported to be too many to list.  The outcome of the event was unknown.; Sender's Comments: Linked Report(s) : US-PFIZER INC-2021092042 same patient, same drug, similar event, different dose separated in times
Age: 80.0
Sex: U
Vaccine: COVID19, COVID19
Symptoms: Chills, Fatigue, Pyrexia
Clinical narrative: chills; fever; fatigue; This is a spontaneous report from a contactable consumer (patient). The consumer reported similar event in two dosage. This is the second of two reports. An 80-year-old patient of an unspecified gender received second dose bnt162b2 (BNT162B2), via an unspecified route of administration, administered in Arm Left on an unspecified date (Lot Number: EL6201) as SINGLE DOSE for covid-19 immunisation.  Medical history included diagnosed allergies, compromised immune status, respiratory illness, diabetes, obesity.  The patient's concomitant medications included Regular meds and Xylenol.  The patient previously received first dose bnt162b2 (Lot number EL3302) on 20Jan2021 for covid-19 immunization and experienced sudden tiredness, Fleeting mild headaches in recovery, Nausea, Fierce diarrhea, Very sick for two hours, Muscle aches instead still there, Vomited.  The patient experienced chills, fever and, fatigue on an unspecified date. Time of onset was 8 am next day. Adverse events did not require visit to Emergency room and visit to Physician office. Th patient did not receive event prior Vaccinations(Within 4 weeks). Relevant test was reported to be too many to list.  The outcome of the event was unknown.; Sender's Comments: Linked Report(s) : US-PFIZER INC-2021092042 same patient, same drug, similar event, different dose separated in times
Age: 47.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Burning sensation, Rash, Rash pruritic, Sleep disorder
Clinical narrative: A mild rash developed on chin Within a week, the rash spread to neck, upper lip, nose, and eyebrows. By two weeks, the rash worsened.; By two weeks, the rash worsened and developed red bumps and blisters with intense itching and burning 24 hours/day; By two weeks, the rash worsened and developed red bumps and blisters with intense itching and burning 24 hours/day; By two weeks, the rash worsened and developed red bumps and blisters with intense itching and burning 24 hours/day; This is a spontaneous report from a contactable Consumer (patient). A 47-year-old non pregnant female patient received first dose of bnt162b2 (BNT162B2, Solution for injection, Lot number: EL9264, Expiration date was not reported), via an unspecified route of administration, in right arm on 27Jan2021 15:30 as single dose for covid-19 immunisation. Relevant medical history reported as none. Concomitant medication included metronidazole (FLAGYL), levocetirizine dihydrochloride (XYZAL) and melatonin all are taken for an unspecified indication, start and stop date were not reported.  It was reported that a mild rash developed on chin within 48 hours. Within a week, the rash spread to neck, upper lip, nose, and eyebrows. By two weeks, the rash worsened and developed red bumps and blisters with intense itching and burning 24 hours/day on 29Jan2021 05:00 PM. No changes in diet, facial products, cleaning/detergent products and have been wearing a mask since August with no issues. Patient did not have covid prior vaccination. Patient did not test for covid post vaccination. Patient received the treatment of adverse event was Prescribed Elidel, Montelukast, Allegra, Doxepin. The outcome of the events was not recovered.
Age: 47.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Blister, Burning sensation, Pruritus, Rash
Clinical narrative: A mild rash developed on chin Within a week, the rash spread to neck, upper lip, nose, and eyebrows. By two weeks, the rash worsened.; By two weeks, the rash worsened and developed red bumps and blisters with intense itching and burning 24 hours/day; By two weeks, the rash worsened and developed red bumps and blisters with intense itching and burning 24 hours/day; By two weeks, the rash worsened and developed red bumps and blisters with intense itching and burning 24 hours/day; This is a spontaneous report from a contactable Consumer (patient). A 47-year-old non pregnant female patient received first dose of bnt162b2 (BNT162B2, Solution for injection, Lot number: EL9264, Expiration date was not reported), via an unspecified route of administration, in right arm on 27Jan2021 15:30 as single dose for covid-19 immunisation. Relevant medical history reported as none. Concomitant medication included metronidazole (FLAGYL), levocetirizine dihydrochloride (XYZAL) and melatonin all are taken for an unspecified indication, start and stop date were not reported.  It was reported that a mild rash developed on chin within 48 hours. Within a week, the rash spread to neck, upper lip, nose, and eyebrows. By two weeks, the rash worsened and developed red bumps and blisters with intense itching and burning 24 hours/day on 29Jan2021 05:00 PM. No changes in diet, facial products, cleaning/detergent products and have been wearing a mask since August with no issues. Patient did not have covid prior vaccination. Patient did not test for covid post vaccination. Patient received the treatment of adverse event was Prescribed Elidel, Montelukast, Allegra, Doxepin. The outcome of the events was not recovered.
Age: 60.0
Sex: M
Vaccine: COVID19, COVID19, COVID19, COVID19
Symptoms: Arthralgia, Asthenia, CSF culture, CSF test, Computerised tomogram thorax
Clinical narrative: mild numbness and tingling arms and legs; mild numbness and tingling arms and legs; weakness in legs; This is a spontaneous report from a contactable physician (patient). A 60-year-old male patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Batch/Lot Number: EK5730), dose 1 via an unspecified route of administration, administered in Arm Left on 17Dec2020 15:00 (at the age of 60years) as single dose for Covid-19 immunization. Medical history included hypertension, GERD (gastrooesophageal reflux disease), prostate cancer, broncholith left lung; all from an unspecified date. Concomitant medications included amlodipine, losartan, pantoprazole, hydrochlorothiazide (HCTZ), and acetylsalicylic acid (ASPIRIN (E.C.)); all taken for an unspecified indication, start and stop date were not reported. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. On 18Dec2020, the patient initially experienced mild numbness and tingling in arms and legs following first dose of vaccine, followed by progressive weakness in legs. The patient was hospitalized for 6 days from an unspecified date to an unspecified date. The events resulted in Doctor or other healthcare professional office/clinic visit, Emergency room/department or urgent care, Hospitalization, and Disability or permanent damage. The patient was tested for Covid-19 post vaccination (Nasal Swab) 24Jan2021 with negative result. The outcome of events was recovering.