chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Initial unsolicited report received from a consumer on 26 October 2015. This case involves a (37-year-old) female patient who was vaccinated with intradermally [series not reported] dose of FLUZONE ID (batch number UT5350AA, expiry date 30 June 2016) in left deltoid on 23 October 2015. Patient had received FLUZONE IM vaccine for past 11 years and never had a reaction. Pre-existing physician diagnosed allergies, birth defects, medical conditions was reported as allergy to FLAGYL, iodine and contrast dye. Other medical history was reported as Lupus. Concomitant medications were not reported. On 23 October 2015, three hour following the vaccination patient had experienced "flare up" of her Lupus. Patient experienced rash, joint pain, fatigue, headache as her symptoms of "flare up" of Lupus. Patient required emergency room (ER)/doctor visit. Patient lab data was not reported. The patient received 40 mg prednisone as corrective treatment. The patient was not recovered at the time of report. Upon medical review, the case was considered as serious due to important medical event lupus, fatigue, rash, joint pain and headache. List of documents held by sender: none.
Redness, swelling, and itching. As of today, redness and swelling has resolved. Itchiness persists.
a severe metallic taste in mouth/metallic taste was unbearable; Nausea; low grade fever 99.7; swollen lymph nodes; aching muscles, joints; aching muscles, joints; terrible headache; cough/lingering cough; general feeling of illness; bedridden for approx. 36 hours; didn't want to eat anything; tired; This is a spontaneous report from a contactable consumer (patient). This 57-year-old non-pregnant female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; lot FD8448) on 19Aug2021 at 02:30 PM, at the age of 57 years, as the second single dose, in left arm, for COVID-19 immunisation. No other vaccine was administered in 4 weeks. Medical history included blood clotting disorder and food allergies. The patient received the first dose of BNT162B2 vaccine on 29Jul2021 at 02:30 PM (lot FA7485), at the age of 57 years, in left arm. The patient did not have COVID prior vaccination. Concomitant medications were none. On 19Aug2021 at 15:30, within an hour of 2nd vaccination, the patient developed a severe metallic taste in mouth. This lasted approximately 24 hours. Nausea developed within 6 hours followed by low grade fever 99.7, swollen lymph nodes, aching muscles, joints, etc., terrible headache, cough and general feeling of illness. Paracetamol (TYLENOL) was taken every 4 hours to manage symptoms. She was bedridden for approximately 36 hours and didn't want to eat anything. Improvements began slowly after 36 hours. Now 72 hours later she was really tired with a lingering cough. The metallic taste was unbearable. The events resolved on an unspecified date in Aug2021.
Pharmacy technician administered to patient vaccine. Patient was given vaccine and told to wait 15 minutes post vaccination in observation area. Initially, he felt ok, with no signs of adverse effects. After 5 minutes, patient stated he felt dizzy, shortness of breath, and had a feeling of "feeling high." Technician asked pharmacist to examine patient after hearing this. Pharmacist asked patient how he was feeling, if his shortness of breath and feeling dizzy was getting worse or stabilizing. Patient stated to pharmacist he feels only dizzy at the moment. Pharmacist recommended patient to take a sip of water and patient complied. Shortly after this (about 3 minutes), patient vomited. After patient vomited, he stated he felt better. Pharmacist and technician asked patient to continue sitting for observation for another 20 minutes. After 20 minutes, patient stated he felt normal again with no previous adverse effects. We advised patient to be careful and should he feel anything else at home to contact medical services.
Left ear pain; Left jaw pain; left jaw numbness; Flu like symptoms; Severe burning in legs; This is a spontaneous report from a contactable consumer (patient).   This 50-year-old female patient (not pregnant) received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, Lot number EA0170), on 14Apr2021 (at the age of 50-year-old) at single dose for COVID-19 immunisation. Relevant medical history included latex allergy and hypothyroidism. Relevant concomitant medications included levothyroxine sodium (SYNTHROID) for hypothyroidism and ethinylestradiol, ferrous fumarate, norethisterone acetate (LO LOESTRIN FE). On 14Apr2021 at 17:00, the patient experienced severe burning in legs. On 15Apr2021, the patient experienced flu like symptoms. On 03May2021, the patient had an appointment with doctor for advice on whether to go ahead with 2nd shot as legs had been burning off and on since first shot. On 04May2021 the patient experienced left ear pain, left jaw pain and left jaw numbness. The events resulted in doctor or other healthcare professional office/clinic visit. No therapeutic measures were taken as a result of the reported events. The clinical outcome of the events severe burning in legs, flu like symptoms, left ear pain, left jaw pain and left jaw numbness were not recovered at the time of this report.  No follow-up attempts are needed. No further information is expected.
Patient falsified date of birth on her immunization screening form and verbally confirmed the wrong date of birth at point of immunization, so she received the incorrect COVID-19 vaccine manufacturer for her age. No adverse events were reported when patient's mom contacted pharmacy a few hours post vaccination to report the incident. Patient's mom will continue to monitor patient and call pharmacy if any adverse reactions reported.
Nausea; Soreness; Arm became sore with pressure; Redness; This case was reported by a consumer via call center representative and described the occurrence of nausea in a 80-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   On 22nd September 2020, the patient received the 1st dose of Shingrix (intramuscular). In September 2020, less than a week after receiving Shingrix, the patient experienced erythema. On 22nd September 2020, the patient experienced pain and pain in arm. On 24th September 2020, the patient experienced nausea. On an unknown date, the outcome of the nausea was recovered/resolved and the outcome of the erythema, pain and pain in arm were unknown.   It was unknown if the reporter considered the nausea, erythema, pain and pain in arm to be related to Shingrix.  Additional details were as follows: The patient received 1st dose of Shingrix intramuscularly in right arm. After receiving 1st dose of Shingrix, the patient experienced redness, soreness, nausea and arm became sore with pressure. The patient had some medicine. The reporter reported that, all information was not available. The reporter consented to follow up.
pt recvd vax; 24oct95 devel a cold & had asthma attack because of cold; reporter felt that cold & asthma attack were not related to therapy w/ varicella vax;
Inappropriate Reconstitution Technique/administered the vaccine diluent/adjuvant was without active component; Inappropriate Reconstitution Technique/administered the vaccine diluent/adjuvant was without active component; This non-serious case was reported by a pharmacist via call center representative and described the occurrence of inappropriate preparation of medication in a 63-year-old male patient who received Herpes zoster (Shingrix) (batch number 432BC, expiry date 25-OCT-2024) for prophylaxis.   On 20-JUL-2023, the patient received the 2nd dose of Shingrix (intramuscular). On 20-JUL-2023, an unknown time after receiving Shingrix, the patient experienced inappropriate preparation of medication (Verbatim: Inappropriate Reconstitution Technique/administered the vaccine diluent/adjuvant was without active component) and inappropriate dose of vaccine administered (Verbatim: Inappropriate Reconstitution Technique/administered the vaccine diluent/adjuvant was without active component). The outcome of the inappropriate preparation of medication and inappropriate dose of vaccine administered were unknown.   Additional Information: GSK receipt date 19 Jul 2023: The reporter was an HCP/pharmacist. The reporter stated that there was an error with a Shingrix vaccine administration. The vaccine was not premix before providing the second dose. The reporter stated that patient was administered the vaccine diluent/adjuvant was without active component. The reporter consented to follow up. The patient was administered the vaccine diluent/adjuvant was without active component which led to inappropriate preparation of medication and inappropriate dose of vaccine administered.
Chills, headache, muscle aches, slight fever, fatigue from 9 am on the day after the vaccination; adverse reaction lasted 24 hours.
Within about a minute of receiving the vaccine, Patient stated she was feeling lightheaded. She started to lose consciousness/faint. I kept asking her if she was with me, and she would slowly and softly respond yes. Ice packs were placed on her neck and wrists and feet elevated. Patient stated that she was sweating. Within 5 minutes patient was approaching normal. Patient was kept and additional 15 minutes in the pharmacy and observed. Water was given to her at this time. Patient stated they felt fine by the time she left.
When shot given, there was instant pain in entire arm. Continued pain with movement and lifting. Seen in clinic on 10/30/17. Diagnosed with left shoulder bursitis post injection. Treated with ice application 2-3 times a day and Ibuprofen 400 mg tablet - take 3 times a day.
Following the injection, after approximately four hours later I began to feel some slight disorientation and tiredness. Later the same evening I experienced brain fog and confusion for the next several days as well as a terrible headache. Additionally my tongue felt tingly.  All of these symptoms passed within several 3- 4 days following the vaccination. injection site discomfort was also a symptom.
Pt stated he felt faint while sitting in waiting area and like he was going to pass out. Cot brought over and staff assisted pt to lie on cot. EMT took over assessment of pt. VS temp 97.4, p 76, BP 123/69, resp. 15, blood sugar 96. Pt never lost consciousness completely. Pt given an ice pack for forehead.PT oriented to person , place, time, event.  Family present and states pt has history of passing out with immunizations.  EMT assessed pt and called for transport. Pt transported via EMS squad unit to Hospital at 2:05 pm.
Injection site redness and itching Skin discoloration on underside of arm in blacks, blues, and greens.  Not tender to touch Pt contacted us 12/1/19 and was going to follow up with her provider.  We made several attempts to follow up with her, but she did not return our calls
Fatigue; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP).  A 12 year-old male patient received bnt162b2 (COMIRNATY), administered in arm left, administration date 06Dec2021 19:00 (Batch/Lot number: unknown) at the age of 12 years as dose 1, single for covid-19 immunisation. The patient had no relevant medical history. The patient's concomitant medications were not reported. The following information was reported: FATIGUE (non-serious) with onset 15Dec2021 07:00, outcome "not recovered", described as "Fatigue". Relevant laboratory tests and procedures are available in the appropriate section. Therapeutic measures were not taken as a result of fatigue.  Additional information: Did the patient receive any other vaccines within 4 weeks prior to the COVID vaccine: No. Prior to vaccination, was the patient diagnosed with COVID-19?: No. Since the vaccination, has the patient been tested for COVID-19?: Yes.  The lot number for bnt162b2 was not provided and will be requested during follow up.
Patient complaining of very high fever and non stop shaking and trouble breathing the night she received the vaccines. Patient felt ill for 3 days. She is currently asymptomatic.
Abdominal pains, Chest pains or sensations, Dizziness or balance problems, Fatigue, lethargy or weakness, Headache, Hearing problems or ringing in ears, Itching, tenderness or swellings, Memory or thinking problems, Muscle or joints pains, Muscle weakness or tremor, Sexual problems, Sleep problems, Wheezing, cough or shortness of breath, lump on upper left abdomen causes pain. Have there been other symptoms like this associated with anthrax? What do I need to do to get properly treated? I feel like there is a lump in my throat all the time. And it's harder to breath lying down. This 40 year old patient began updating his vaccinations in preparation for deployment in April 2004. He reported no adverse events with receipt of hepatitis B #1, yellow fever and typhoid vaccine on 26 April 2004 or with his second hepatitis B vaccination on 21 June 2004. He reported having a sinus infection 2-4 weeks prior to his AVA series treated with steroids and antibiotics. His anthrax series began on 11 July 2004 along with administration of the smallpox vaccine, meningococcal, tetanus-diphtheria, polio, and measles-mumps-rubella.  He reported sleeping for 16 hours post vaccinations feeling extremely sore with diffuse joint and muscle aches that lasted for a few days before resolving. He was using Celebrex or Naprosyn at the time for torn ligaments to his right elbow following a football injury weeks before. His second and third anthrax vaccinations were administered on 25 July 2004 and 14 August 2004 without any remembered adverse effects. Hepatitis A and Influenza Vaccines received on 01 November 2004 reported no adverse events. However, he reported continued right elbow discomfort requiring cortisone injections with onset of left knee pain (unknown cause/onset) prior to deployment on 22 November 2004.
On 7/29/2022, I started having like a head cold, stuffy head, not a big deal and a cough.  Around 3 days later, I took a COVID-19 home test and it was positive with 5 seconds. I reported online to my doctor's office that I had COVID-19. A doctor called me back and prescribed a specialized reduced prescription of Paxlovid because I have a reduced kidney function.  I had diarrhea and I was extremely tired during that time.  Five days later, I tested again, and the results were negative, and symptoms were gone. I just recently started having recurring diarrhea about every 10 or 15 days.  It started in September. The doctor thought that maybe there is a relation with me having COVID-19, because I had the diarrhea when I had COVID-19.  I have an appointment with my doctor to follow up on this.
Mild fever of up to ~101.5F, felt better after 12-18 hours.
pt leg felt rubbery & tingling, deep muscle pain;could hardly pick legs up;felt like shot w/novocaine;looked sick;lt hand shaking;MCV level elevated;bruising everywhere;exhausted;pt upset & scared;frostbite sensation;
developed  chest pains 20 minutes after getting the first vaccine, continued for the next 4 days until I was diagnosed as having myocarditis by my primary care physician.  Having heart palpitations and flutters, lightheaded, dizzy, very uncomfortable chest pressure almost all day.  I am on day 5 of having the vaccine and the symptoms have not subsided.
Headache began within 1 hr., 102° temp next day, extreme soreness on entire body, injection site swelled & hardened, neck hurt on spine, could hear swooshing sounds in head, made me off balance, all passed after 3 days except left me lethargic for a few days. I;m still glad I took it: Shingles last much longer.
318 patients received dose from vials beyond 30-day use by date; This spontaneous case was reported by a nurse and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (318 patients received dose from vials beyond 30-day use by date) in a 63-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 037C21A) for COVID-19 vaccination.     No Medical History information was reported.    On 11-Jun-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 11-Jun-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (318 patients received dose from vials beyond 30-day use by date). On 11-Jun-2021, EXPIRED PRODUCT ADMINISTERED (318 patients received dose from vials beyond 30-day use by date) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No Concomitant medications were reported.  Date of Refrigeration of vaccine 07-MAY-2021  No Treatment information was reported.
8 days out from my first vaccine and I?m now having constant twitching around the vaccine site on my left arm.
Acute ITP; Heart rate dropped to 47; Shortness of breath; Heart rate dropped to 47; This spontaneous case was reported by a physician (subsequently medically confirmed) and describes the occurrence of IMMUNE THROMBOCYTOPENIA (Acute ITP), the first episode of HEART RATE DECREASED (Heart rate dropped to 47), DYSPNOEA (Shortness of breath) and the second episode of HEART RATE DECREASED (Heart rate dropped to 47) in a 25-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.   On 26-Feb-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 29-Mar-2021, the patient experienced IMMUNE THROMBOCYTOPENIA (Acute ITP) (seriousness criterion hospitalization). On 01-Apr-2021, the patient experienced the first episode of HEART RATE DECREASED (Heart rate dropped to 47) (seriousness criterion hospitalization), DYSPNOEA (Shortness of breath) (seriousness criterion hospitalization prolonged) and the second episode of HEART RATE DECREASED (Heart rate dropped to 47) (seriousness criterion hospitalization). The patient was hospitalized on 29-Mar-2021 due to DYSPNOEA, HEART RATE DECREASED and IMMUNE THROMBOCYTOPENIA. At the time of the report, IMMUNE THROMBOCYTOPENIA (Acute ITP) had not resolved and DYSPNOEA (Shortness of breath) and the last episode of HEART RATE DECREASED (Heart rate dropped to 47) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 29-Mar-2021, Platelet count: about 2000 (Low) About 2000. On 01-Apr-2021, Heart rate: dropped to 47 (abnormal) Dropped to 47. On 02-Apr-2021, Platelet count: low (Low) Low.     For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   Treatment included: steroids [also noted as dexamethasone (DECADRON)] and IV IgG.  At the time of the report, the patient was being transferred to another hospital facility.  Based on the current available information which includes a temporal association between the use of the product and onset of the reported events and excluding other etiologies, a causal relationship cannot be excluded.; Sender's Comments: Based on the current available information which includes a temporal association between the use of the product and onset of the reported events and excluding other etiologies, a causal relationship cannot be excluded.
fatigue.; daughter got pretty sick after receiving the 2nd dose; fever; chills; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) from medical information team for a Pfizer sponsored program (159558). The reporter is the parent.  A 28 year-old female patient received bnt162b2 (BNT162B2) (Batch/Lot number: unknown) as dose 2, single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: Bnt162b2 (dose: 1, Batch/Lot number: Unknown), for covid 19 immunization. The following information was reported: FATIGUE (non-serious), outcome "unknown", described as "fatigue."; ILLNESS (non-serious), outcome "unknown", described as "daughter got pretty sick after receiving the 2nd dose"; PYREXIA (non-serious), outcome "unknown", described as "fever"; CHILLS (non-serious), outcome "unknown", described as "chills". No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Experiencing a constant smell; appears to be a "phantom" smell - not related to anything around me or on me. It is hard to describe the smell, but it is not a bad smell and is not an unpleasant smell,; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 58-year-old female patient (not pregnant) received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection), administration date 04Mar2021 (Batch/Lot number: unknown) at the age of 58 years as dose 1, single for COVID-19 immunisation. The patient had no relevant medical history. There were no concomitant medications.  The following information was reported: PAROSMIA (non-serious) with onset 10Mar2021, outcome "not recovered", described as "Experiencing a constant smell; appears to be a "phantom" smell - not related to anything around me or on me. It is hard to describe the smell, but it is not a bad smell and is not an unpleasant smell,". Therapeutic measures were not taken as a result of parosmia.  Additional information: The patient did not receive other vaccine in four weeks. The patient did not receive other medications in two weeks. The patient did not have COVID prior vaccination. The patient had not been tested for COVID post-vacicnation. The patient had no known allergies.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Narrative:  Patient received three doses of Moderna COVID-19 vaccine on 4/1/21, 4/27/21, and 11/30/21. Patient was transferred from emergency department on 8/19/2022 due to COVID-19 infection causing acute-on-chronic hypoxemic respiratory failure. Patient's wife tested positive for COVID recently. In hospital, received treatment with remdesivir.
Post vax, the pt fainted. He developed a rash his whole body several hours later. Rash still present on 11/6/00.
rash just one spot on her arm since it's spread to her legs and other places; This is a spontaneous report from a contactable Physician reported that. A 27-years-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection), dose 1 via an unspecified route of administration on 07Mar2021 (Batch/Lot number was not reported) as DOSE 1, SINGLE for covid-19 immunizations (Age at vaccination 27 years). The patient medical history and concomitant medications were not reported. After 24 hours later she started to get a rash just one spot on her arm since it's spread to her legs and other places on 08Mar2021. She's been on a couch with wool blanket and duck feathers. lying there more allergic to wool or feathers. it started 24 hours after she got the vaccine; not considered severe, not anaphylaxis; not within 4 hours; she went to the dermatologist is on prednisone hate for her not to get the 2nd vaccine, so she said to herself let me call and see if there is any information on migrating rash not coming from the allergic reactions are more systemic. The event outcome was unknown.
Mother calling to state daughter developed a 1/4 inch broken blood vessel in the outer rt aspect of her eye that she noticed at around 3pm this afternoon.  Mother states pt has no other sx and denies headache, fever or vision loss.  Mothers state her only concern is that pt had her vaccines yesterday.  Mother would like to know what to watch for.  Mother aware to monitor the eye and contact our clinic or ER in the event that pt develops headache, fever, or visual problems.  Mother will call a medical facility if other sx occur in which she has questions about.  CDC paperwork to be completed.  Mother will report to the our office tomorrow to inform us of her sx.