chrisvoncsefalvay/vaers-outcomes huggingface dataset:
This spontaneous report received from a patient concerned a female of unspecified age. The patient's height, and weight were not reported. The patient's pre-existing medical conditions included the patient was not pregnant at the time of reporting. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 1805029, and batch number: 1805029 expiry: UNKNOWN) dose was not reported, administered on 12-MAR-2021 16:00 for prophylactic vaccination. No concomitant medications were reported. On 12-MAR-2021, the subject experienced cold. On 12-MAR-2021, the subject experienced chills. On 12-MAR-2021, the subject experienced rash on her face, neck and chest. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the chills, cold and rash on her face, neck and chest was not reported. This report was non-serious.
He had chest pain after both shots; Nerves wrapping around, agitated nerve issue from his back surgery; Had no feeling/ bump with spongy dead tissue.; Little bump in the arm and tissue, a bump with spongy dead tissue; He had  headache after both shots; This spontaneous case was reported by a consumer and describes the occurrence of CHEST PAIN (He had chest pain after both shots), NERVE INJURY (Nerves wrapping around, agitated nerve issue from his back surgery), PERIPHERAL SWELLING (Little bump in the arm and tissue, a bump with spongy dead tissue), HEADACHE (He had  headache after both shots) and HYPOAESTHESIA (Had no feeling/ bump with spongy dead tissue.) in a 65-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 010M20A) for COVID-19 vaccination.     The patient's past medical history included Back surgery (patient says he has an agitated nerve issue from his back surgery and always has some sort of chest pain). Concurrent medical conditions included COPD.   On 29-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced CHEST PAIN (He had chest pain after both shots), NERVE INJURY (Nerves wrapping around, agitated nerve issue from his back surgery), PERIPHERAL SWELLING (Little bump in the arm and tissue, a bump with spongy dead tissue), HEADACHE (He had  headache after both shots) and HYPOAESTHESIA (Had no feeling/ bump with spongy dead tissue.). At the time of the report, CHEST PAIN (He had chest pain after both shots), NERVE INJURY (Nerves wrapping around, agitated nerve issue from his back surgery) and HEADACHE (He had  headache after both shots) had resolved and PERIPHERAL SWELLING (Little bump in the arm and tissue, a bump with spongy dead tissue) and HYPOAESTHESIA (Had no feeling/ bump with spongy dead tissue.) outcome was unknown.      mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown Route) dosing remained unchanged.   The concomitant medications were not reported.   The treatment information was not provided.   This case was linked to MOD-2021-296249 (Patient Link).
Initial information received on 11-Sep-2018 regarding an unsolicited valid non-serious case received from a pharmacist. This case involves a 63 years old female patient who experienced injection site reaction- a small bulge formed at site and grew in size, bulge grew to about the diameter of a nickel and was raised to a height of about 3 stacked nickels and injection today into right deltoid and it bled more than usual, while she received vaccine FLUBLOK QIV. The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided. On 11-Sep-2018, the patient received a 0.5 mL dose of suspect INFLUENZA QUADRIVALENT RECOMBINANT VACCINE, lot QFAA1812 via unknown route in the right deltoid (frequency-once). On 11-Sep-2018, on same day of post-vaccination, patient developed a non-serious injection site reaction- a small bulge formed at site and grew in size, bulge grew to about the diameter of a nickel and was raised to a height of about 3 stacked nickels (injection site mass) and injection today into right deltoid and it bled more than usual (Injection site bleeding). Relevant tests were not reported. Final diagnosis was injection site reaction- a small bulge formed at site and grew in size, bulge grew to about the diameter of a nickel and was raised to a height of about 3 stacked nickels and injection today into right deltoid and it bled more than usual. It was not reported if the patient received a corrective treatment. The outcome of the event was reported as unknown. Documents held by sender: none.
Patient called office and stated they received the flu shot for the first time yesterday (9/29/30) in a long time and when patient got home patient started not feeling well and could not eat dinner. Patient then got fever/nausea/vomiting/chills. Patient still does not feel like herself on 9/30/20 but no longer has fever/achy/chills, only some mild nausea.
full body rash; angry red; pain; skin to peel; itching; This spontaneous case was reported by a pharmacist and describes the occurrence of RASH (full body rash), ERYTHEMA (angry red), PAIN (pain), SKIN EXFOLIATION (skin to peel) and PRURITUS (itching) in a 59-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 012L28) for COVID-19 vaccination.     No medical history was reported by the reporter.    On 29-Jan-2020, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 29-Dec-2020, received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On an unknown date, the patient experienced RASH (full body rash), ERYTHEMA (angry red), PAIN (pain), SKIN EXFOLIATION (skin to peel) and PRURITUS (itching). The patient was treated with TRIAMCINOLONE at an unspecified dose and frequency and PREDNISONE at a dose of UNK mg. At the time of the report, RASH (full body rash) had not resolved and ERYTHEMA (angry red), PAIN (pain), SKIN EXFOLIATION (skin to peel) and PRURITUS (itching) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   No concomitant medication was reported.  Action taken with mRNA-1273 (Moderna COVID-19 Vaccine) was not applicable.   This case was linked to MOD-2021-048001 (Patient Link).
Lymphoma; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) for a Pfizer sponsored program (159558). The reporter is the patient.  A female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) (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:1st), for COVID-19 immunization. The following information was reported: LYMPHOMA (medically significant), outcome "unknown", described as "Lymphoma". The patient with Lymphoma mentioned that she went through the vaccination and did not develop any antibodies, she was asking how she can get the Paxlovid in case she develops Covid.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
I had a burning sensation on vaccine site and all over my left arm, I also developed and rash later  on the day I was given the vaccine. my left arm was sore for two days but there is an aching pain that I continued to have. there is also a spot higher up from the vaccine site and it looks like a ring around it.  the rash remains and continues to itch.
Rt arm pain and itching on vaccination sites, also redness and swelling getting progressively worse. Appeared about 5-6 hours after received vaccine cold compresses, BENADRYL.
tachycardia; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A patient (no qualifiers provided) received BNT162b2 (BNT162B2 NOS), as dose number unknown, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: TACHYCARDIA (non-serious), outcome "unknown". The event "tachycardia" required physician office visit. Additional information: the patient had no previous heart problems before and had a cardiologist visit for the event. The patient was not sure if the event was due to the BNT162b2.  The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.
The evening of the shot I developed severe ringing in my ears Tinnitus, my back started to hurt over kidneys and my neck got very sore and stiff. I am still experiencing these symptoms after 1 week.  This is causing severe anxiety.
Swelling, redness, warmth of RT thigh (site of DTaP-IPV).
Acute aching in all joints for 48 hours. Fluid retention in right knee started sometime during those 48 hours. Continual pain/acing in my whole back that radiates out from spinal column.
Walking around, stumbling, mumbling, banging his head on a cabinet, falling over, eyes moving all over, slurred speak and then confusion. It lasted about 15 minutes and was considered a seizure in January 2014 following an ER visit due to a seizure.
Evaluated by PMD re: Fever, chills, nausea, vomiting, abdominal spasms, headache that begain 3 hours after receiving DT
Decreased energy, L arm hot, red blotchy and swollen upper arm only, no fever.
I was enlisted in the military where in1999 involuntarily I received a series of six anthrax vaccine shots. With recent online research I have learned of others having adverse reactions similar to mine, severe hypothyroidism. I was not diagnosed until 2002, when, I experienced total numbness from my shoulders to my fingertips. I thought I was suffering cardiac arrest at that time. I was sent off to a local hospital. They were not able to diagnose me with anything, so I was sent home to my primary care physician who was able to diagnose me. His presentation of my diagnosis was more than startling. He told me that I have the worst case of this autoimmune disorder he had ever known of and that medically I shouldn't be alive. My tsh was 370 more than seventy times the normal high. He explained that it was not a chemical imbalance. I lost my job almost immediately after notifying them with no reason or notification of termination. At the time I was up for a considerable promotion. I now struggle everyday. It takes more than half the day for my mind and body to wake up. I am lethargic in all that I do. My memory retention is nonexistent. I forget things in mere minutes. I now face lifetime medication for a disease that I should not have. I am seeking compensation for, what was supposed to be protective, but now is punitive. If this is not the appropriate agency please forward to that agency with all attached information. If not possible to do so please direct me to the appropriate agency. Follow up 02/07/05: He reports initial additional symptoms of daily headaches & blistering rash on his abdomen at onset of AE. He currently takes 150 mg Levothyroxine, but his TSH remains elevated. Rash and headache have abated. He has no immuization records, but left the sevice in Aug.1999. He denies receiving other vaccines at the time of the anthrax vaccinations. Follow up 03/07/05: Immunization records indicates 5 doses of anthrax vaccine was administered. These were as follows: Dose #5 07/28/99-Lot #FAV044, Dose #4 03/12/1999-Lot #FAV036, Dose #3 03/04/1999-Lot #FAV038, Dose #2 02/18/1999-Lot#FAV34,  Dose #1 12/15/1998-Lot #FAV36.
Patient received J&J vaccine on 4/7 and suspected to have CVST on 5/5 when she presented to hospital with significant headaches and seizures.   Patient was started on bivalirudin and steroids and given 1 dose of IVIG.    Unclear etiology, patient followed by Neurology and Hematology to determine anticoagulation and management of headaches.
Pfizer / BioNTech- start date: 4Apr2021/ Treatment of COVID-19- start date: 15Aug2022; Pfizer / BioNTech- start date: 4Apr2021/ Treatment of COVID-19- start date: 15Aug2022; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 42-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 04Apr2021 as dose number unknown, single (Batch/Lot number: unknown) at the age of 40 years for covid-19 immunisation. The patient's relevant medical history included: "Insulin resistance" (unspecified if ongoing), notes: Other medical history: Insulin resistance/heart palpitations; "Known allergies: Coconut" (unspecified if ongoing), notes: Known allergies: Coconut; "Known allergies: sulfur" (unspecified if ongoing), notes: Known allergies: sulfur; "heart palpitations" (unspecified if ongoing), notes: Other medical history: heart palpitations. Concomitant medication (Other medication in 2weeks product)(s) included: METFORMIN.  The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant), outcome "unknown" and all described as "Pfizer / BioNTech- start date: 4Apr2021/ Treatment of COVID-19- start date: 15Aug2022". 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 drug ineffective, covid-19 of Paxlovid from 15Aug2022 to 20Aug2022.  The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received
I was given the same vaccination within a one week span when the next required dose was 28 days from the initial dose given.
This is a spontaneous report from a contactable physician through a Pfizer sales representative. A 17-year-old female patient of an unspecified ethnicity received first dose of TRUMENBA, intramuscular on unknown date in Dec2015 single dose. The patient medical history and the patient's concomitant medications were not reported. The patient experienced flu like symptoms on Dec2015. The event lasted a couple of days then resolved. The event was assessed as non-serious.
Tinnitus, started after 2nd vaccine. Not sure if exact date. Primarily left ear only. Variable in terms of  intensity but constant
Dizziness, Headache, Diarrhea, Chills, Lethargy, Injection site pain and swelling, Narrative: Chills, dizziness, lethargy, headache, diarrhea, and injection site pain/swelling. Pain began within several hours and lasted approx. 3 days. Lethargy, was present the next morning, approx. 18 hours after the injection and lasted 2 days. Dizziness and chills began around 10:00 AM the day after the vaccine, approx. 8:00 PM day after vaccine, approx, 28 hours after injection, lasted only one evening. Diarrhea began approx. midnight on the day after the vaccine, 3 episodes during the night, approx. 33 hours after injection and lasted only 1 night. Missed work x 1.5 days. No known prior covid infection
35 minute status seizure. Started with left sided stiffness. EMT diverted to left. Sl. fractory to Ativan x2. Regressive to Fospheaptoin. Tactile fever present during symptoms. No concomitant illness. Onset of seizure 6 hours after vaccination.  10/02/2007 TC to vax provider for vax info.  DTaP- Wyeth-Lot #: CZ606AA. 4th dose.  Prevnar-B47442D. 4th dose.  Database updated with same. 10/09/2007 MR recieved for DOS 9/28-29/2007 for DX: Atypical Seizure. Child presented to ER in status epilepticus.  Child had tactile fever at home then became stiff and started jerking.  Eyes deviated to the left with blank stare. Reportedly stopped breathing without cyanosis.  Lasted 35-40 minutes.  Ativan given x 2 with seizure ongoing. Phenytoin given with resulting hypotension resolved with fluid bolus. Assessment: focal febrile seizure.
pt recvd vax;20 mins later devel neck stiffness & severe HA;also devel petechiae under rt eye & pallor;vital signs nl;to er;MD felt had an allergic rxn; discharged w/o tx;
Syncope, 102/62 (pulse 72), 98/64 (pulse 70). O2 sat 100%. Feeling dizzy post-vaccination and syncope.
Pt seen at Allegan on 8/19 and tested positive for COVID-19 on the Liat.  Pt then admitted on 8/28 for hypoxia at Hospital.
The patient received the Janssen Covid-19 vaccine despite being under the age of 18.
heat in the injection site arm; swollen injection site arm; Redness that extended 3 to 4 inches down my injection site arm; fever of 98.5 degrees Farenheight; injection site arm itched; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE WARMTH (heat in the injection site arm), VACCINATION SITE SWELLING (swollen injection site arm), VACCINATION SITE ERYTHEMA (Redness that extended 3 to 4 inches down my injection site arm), PYREXIA (fever of 98.5 degrees Farenheight) and VACCINATION SITE PRURITUS (injection site arm itched) in a 75-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 014F21A, 012MWA and 027L20A) for COVID-19 vaccination.     No Medical History information was reported.   On 05-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 02-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 27-Oct-2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 27-Oct-2021, the patient experienced VACCINATION SITE WARMTH (heat in the injection site arm), VACCINATION SITE SWELLING (swollen injection site arm), VACCINATION SITE ERYTHEMA (Redness that extended 3 to 4 inches down my injection site arm), PYREXIA (fever of 98.5 degrees Farenheight) and VACCINATION SITE PRURITUS (injection site arm itched). At the time of the report, VACCINATION SITE WARMTH (heat in the injection site arm), VACCINATION SITE SWELLING (swollen injection site arm), VACCINATION SITE ERYTHEMA (Redness that extended 3 to 4 inches down my injection site arm), PYREXIA (fever of 98.5 degrees Farenheight) and VACCINATION SITE PRURITUS (injection site arm itched) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 27-Oct-2021, Body temperature: 98.5 (High) 98.5 degrees Fahrenheit.         No concomitant medications were reported .  It was reported that patient had placed icepack on her arm   This case was linked to MOD-2021-371357 (Patient Link).   Most recent FOLLOW-UP information incorporated above includes: On 01-Nov-2021: Reporter information updated:  Reporter address, Patient details updated: DOB,age, gender ,weight.Vaccination details updated: dose 1, 2 and 3 information.Newevents added :vaccination site warmth, vaccination site swelling ,vaccination site erythema, pyrexia, vaccination site pruritus .
Within minutes of getting the shot, my throat became itchy and the roof of my mouth felt like it was burning.  I started breaking out in hives , coughing and trying to clear my throat.  I was taken to the medical area and given a dose of liquid Benadryl.  Within 20 minutes it was easier to breathe and my blood pressure and pulse ox returned to normal.  About 3 hours later I started to get itchy again around my throat and ears.  Per the guidance of the nurse at the vaccine site, I took 2 - 25mg Benadryl tablets.  By the next morning I felt better.
Redness of 1/3 of right arm, non tender. Started after 24 hours; resolved after 72 hours. No treatment necessary.
This is a spontaneous report from a contactable consumer reporting for herself. This 52- year-old female patient received on an unknown date (about 5 years before this report) a single dose of PREVNAR 13, PNEUMOVAX on an unknown date (about 4 years before this report) and a different pneumonia vaccine taken before pneumococcal 13-val conj vac (dipht crm197 protein) (patient did not know what that was and had no further details), all for immunization. Concomitant medications were not reported. Medical history included ongoing rheumatoid arthritis and lupus. She has developed pneumonia several times since receiving all of these vaccines. Outcome was unknown. Information on the batch number has been requested.
Pfizer BioNTech COVID-19 Vaccine EUA: COVID-19 case resulting in Hospitalization / Death. Patient received Pfizer Vaccine on 03/11/2021 and 04/08/2021. On 8/20/2021, pt presented to ED with increasing shortness of breath. Pt was admitted to a hospital on 8/17/2021 and diagnosed with COVID-19 pneumonia. She was discharged on 8/20/2021 with 4 L NC oxygen. Once discharged patient began to desaturate to 80% and called EMS. Patient was transported to ED and placed on HFNC 50/40 then titrated up to 60/60 and then later 70/60. Her lab work demonstrated elevated procalcitonin and her x-ray demonstrated a multifocal pneumonia.  She was given dexamethasone, Rocephin and remdesivir. On morning of 8/25/21 she was noted to be significantly tachypneic with RR to 40s and slightly altered. Despite ongoing treatment, she declined. Patient expired on 8/25/21.
This spontaneous report as received from a female consumer refers to herself. The patient was vaccinated with GARDASIL (dose, route and lot# not reported). It was reported that the patient experienced the arm where she received the GARDASIL shot hurted. It was unknown if the patient sought medical attention. The outcome of event was unknown. Additional information is not expected.
Client complained of lightheadedness/dizziness after injection, approximately 2-3 minutes duration.  Cool cloth applied to forehead.  About 2-3 minutes later, client complained of throat swelling.  Client was placed on back and vital signs taken while 911 was called.
ON 03/02/2018, PATIENT RECEIVED VACCINE THAT EXPIRED ON 02/23/2018, MERCK WILL BE CONTACTED ON NEXT BUSINESS DAY AND VACCINE STABILITY ALONG WITH PROPER PROTOCOL WILL BE TAKEN.
react lt leg Tetramune by site per mom area warm, swollen hot to touch; advised to apply cold pact to area;
Maculopapular rash on trunk, chest, neck, lesser extent on arms and legs. cough, rhinorrhea.
2 episodes of pass out whom got the second dose; 3 patients felt unwell whom got the first dose; Based on the current case data, this case has been classified as invalid. This spontaneous case was reported by a nurse and describes the occurrence of LOSS OF CONSCIOUSNESS (2 episodes of pass out whom got the second dose) in a  patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 008C21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.    On 29-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced LOSS OF CONSCIOUSNESS (2 episodes of pass out whom got the second dose) (seriousness criterion medically significant) and MALAISE (3 patients felt unwell whom got the first dose). At the time of the report, LOSS OF CONSCIOUSNESS (2 episodes of pass out whom got the last dose) and MALAISE (3 patients felt unwell whom got the first dose) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   Very limited information regarding these events has been provided at this time.  Further information has been requested.   Most recent FOLLOW-UP information incorporated above includes: On 29-Apr-2021: Additional event of malaise reported, 5 total cases reported, event dates provided On 30-Apr-2021: No new information; Sender's Comments: Very limited information regarding these events has been provided at this time.  Further information has been requested.