chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Patient sat down to get vaccines - gave flu shot vaccine first in Left Deltoid; Immunizing technician went to right deltoid to give Covid Booster shot and after Covid shot the patient stated she felt faint and that she was about to throw up. Technician gave her Trashcan and promptly grabbed the pharmacist. When pharmacist entered the immunization room - asked patient what was going on. got her some water and a fan to blow cool air on her. Patient heart rate was 87 bpm when rph came in immunization room at 3:41pm - heart rate lowered with in 2 min to 71 bpm (per patient's smart watch reading). Patient drank some water on her own and stated she was ready to stand up. RPh walked with patient to her car and she walked normally and she felt better. Patient had a driver to already to take her home.
the next day, arm was weak and painful muscles, went all the way down the arm tingling in fingers. still sore and can't raise arm, close car door.
Intermittent tingling of face.  comes and goes.  no other symptoms.  started about 24h after getting shot. still present 1 wk later
Vomiting and slight fever on 10/2/06 day of vaccine, itchy rash mobilliform on day 3 generalized.
Extreme fatigue, lightheadedness, shortness of breath.  Initial onset was rather sudden on 4/29/21 and seen at urgent care without definitive dx and DC'd without treatment and somewhat improved.  Health did not resume to normal and deteriorated again with same sx on 5/1/21; presented to UC again and transferred to main ED.  Again, DC'd without definitive dx or tx ordered and marginally improved at the time of DC.  Sx worsened again prompting another visit to the ED on 5/3/21 and again DC'd without definitive dx or tx.
This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION COMPLICATION (side effects from the vaccine) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. Unknown) for COVID-19 vaccination. No Medical History information was reported. In January 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 VACCINATION COMPLICATION (side effects from the vaccine). At the time of the report, VACCINATION COMPLICATION (side effects from the vaccine) outcome was unknown. The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown. Concomitant medications was not provided by the reporter. Treatment information was not provided. This case was linked to MOD-2021-311281.
On Feb. 20th noticed a big red circle where I had been given the shot. It is not hard but is very warm to the touch. Does not hurt but i know that it is there. This is 12 days after the shot
Received Moderna vaccines on 2/11/21 and 3/11/21. Tested positive for COVID-19 by PCR on 7/9/2021. Will received monoclonal antibody therapy.
severe pins and needles sensation in both hands, feet and legs; This spontaneous case was reported by a physician and describes the occurrence of PARAESTHESIA (severe pins and needles sensation in both hands, feet and legs) in a 37-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 027C21A) for COVID-19 vaccination.     Concurrent medical conditions included Allergy (spring allergy). Concomitant products included VITAMIN D NOS for Vitamin D deficiency.    On 21-May-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 22-May-2021, the patient experienced PARAESTHESIA (severe pins and needles sensation in both hands, feet and legs). The patient was treated with PARACETAMOL (TYLENOL) for Pins and needles, at a dose of 1 dosage form. At the time of the report, PARAESTHESIA (severe pins and needles sensation in both hands, feet and legs) had not resolved.        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.   Most recent FOLLOW-UP information incorporated above includes: On 13-Jul-2021: Follow up received on 13 Jul 2021 and it contains patient demographics and medical history updated.
facial urticaria & @ inj site;no cardioresp sxs;DPH given
Heart palpitations and shortness of breath started 4 days after the 2nd dose of Pfizer covid vaccine. The symptoms resolved in next few days but retuned 20 days later and it was sever than the first time. Heart palpitations and shortness of breath is still happening till today (7/3/21). The heart rate is normal when resting but goes up to 170 and shortness of breath even when walking few steps or doing any mild work. Never had this issue before the vaccine, all these started happening after 2nd dose of Pfizer covid vaccine
Severe left neck lymphadenopathy developed on the side of the injection.  Also, left lingual tonsil hypertrophy developed on the side of injection.
Vaccination after 36 days; This spontaneous case was reported by a consumer and describes the occurrence of INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Vaccination after 36 days) in a 57-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 013A21A and 042L20A) for COVID-19 vaccination.     The patient's past medical history included No adverse event (No adverse event).   On 05-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) .5 ml. On 31-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 31-Mar-2021, the patient experienced INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Vaccination after 36 days). On 31-Mar-2021, INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Vaccination after 36 days) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No concomitant medications were provided. Treatment medications were unknown.; Sender's Comments: This report refers to a case of Inappropriate schedule of product administration, for mRNA-1273, lot # 013A21A, with no associated AEs.
This spontaneous report was received from a nurse and refers to an 8 week old patient of unknown gender. The patient's relevant medical history, concurrent conditions, concomitant medications, drug reactions or allergies were not reported. On 13-SEP-2017, the patient was vaccinated with improperly stored vaccines, RECOMBIVAX HB (dosing details not reported) (lot # N006321, expiry date: 08-NOV-2019) and ROTATEQ (dosing details not reported) (lot # M044397, expiry date: 20-JUN-2018, orally) for prophylaxis. No adverse effects were reported. The administered vaccines underwent a temperature excursion from 0 degree Celsius (C) to 1 degree C (0.8 degree C) for 52 minutes. The previous temperature excursion was reported as 9 degree C to 25 degree C (10.9 degree C) for 3 hours 17 minutes. The call was because of a data logger. No product quality complaint was involved. This is one of several reports received from the same reporter. Sender's Comments: US-009507513-1709USA007011.
Developed erythematous, pruritic swelling to L arm which started 2 hours after injection.  Area was 2 inches in diameter.  Cold pack and Ibuprofen for relief.
large red area around inj site lt arm the size of a baseball, warm to touch;ATB-Duracef x 10 days;PDH, warm compresses;
pt stated about 2 hours after receiving her covid vax that her heart was racing, beating harder than normal but subsided after about 2 hours.  She was about to go to the ER but waited a little longer since she thought she was just having anxiety issues and did not have to go.   She will contact her PCP today to let them know and discuss getting the second dose.
Dysphagia, muscle spasm, severe pain over chest wall. 60 day follow up states it is unknown if pt has recovered. The medical record states nausea, vomiting, and short of breath. Follow up on 5/26/2004: states it is unknown if pt has recovered.
had the typical reaction of having sore arm after vaccination; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) from medical information team. The reporter is the patient.  A female patient received bnt162b2 (BNT162B2) (Batch/Lot number: unknown) as dose 2, single for covid-19 immunisation. Relevant medical history included: "Hypertension" (unspecified if ongoing). The patient's concomitant medications were not reported. Vaccination history included: Bnt162b2 (DOSE 1), for COVID-19 IMMUNIZATION. The following information was reported: PAIN IN EXTREMITY (non-serious) with onset 2021, outcome "recovered" (2021), described as "had the typical reaction of having sore arm after vaccination". Clinical course: The patient got the two doses of the Pfizer COVID-19 vaccine. However, she didn't really think she received the first dose of the Pfizer COVID-19 vaccine. When she received the first dose of the vaccine, the vaccination provider slipped around and pulled away from the patient. The patient did not feel the liquid coming into her arm. She asked her vaccination provider if the vaccine was given and the vaccination provider said yes. She did not have any adverse event following vaccination with first dose. When she got the second dose of the vaccine, she felt the liquid coming in and it strengthen her belief that she did not receive the first dose of the vaccine. She had the typical reaction of having sore arm after vaccination for half a day. She wanted to now if there is any way to asses if she got the first dose of the vaccine.  No follow-up attempts are possible. No further information is expected.
Consumer missed 2nd dose; This spontaneous case was reported by a consumer and describes the occurrence of PRODUCT DOSE OMISSION ISSUE (Consumer missed 2nd dose) in a 47-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 041C21A) for COVID-19 vaccination.     No Medical History information was reported.    On 28-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 PRODUCT DOSE OMISSION ISSUE (Consumer missed 2nd dose). At the time of the report, PRODUCT DOSE OMISSION ISSUE (Consumer missed 2nd dose) had resolved.            No concomitant and treatment medications were reported.
Petechial rash on trunk/buttocks. Seen by diagnosed by MD. Also very swollen lymph gland in neck.
Diabetes Mellitus Type 1, became very dehydrated, blood sugars were in the 900's, taken to the hospital and was given insulin and fluids and continue to take insulin daily, for the rest of my life to survive.
This spontaneous report as received from a Registered Nurse (RN) refers to a multiple different unspecified patients of unknown age and gender. Medical history and concurrent conditions were not provided. The patients were vaccinated with a dose PNEUMOVAX23 (dose, route, lot number and expiration date were not reported) "every year" since an unspecified date. There was no concomitant medication provided. No adverse effects reported. This is one of two reports received from the same reporter. Additional information has been requested.
Arm turned red from elbow area to her wrist; This spontaneous case was reported by a consumer and describes the occurrence of ERYTHEMA (Arm turned red from elbow area to her wrist) in an 83-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On an unknown date, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced ERYTHEMA (Arm turned red from elbow area to her wrist). At the time of the report, ERYTHEMA (Arm turned red from elbow area to her wrist) outcome was unknown. Not Provided          This case was linked to US-MODERNATX, INC.-MOD-2021-064236 (E2B Linked Report).; Sender's Comments:  US-MODERNATX, INC.-MOD-2021-064236:Second dose
had a sore arm; and a fever that didn't go over 99.9F yesterday; This is a spontaneous report from a contactable consumer or other non hcp (patient). A 39-years-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, Batch/Lot number was not reported), via an unspecified route of administration on 11Aug2021 (at the age of 39-year-old) as dose 1, single for covid-19 immunisation. The patient medical history and concomitant medications were not reported. On 11Aug2021, the patient experienced had a sore arm, and a fever that didn't go over 99.9f yesterday. The patient underwent lab tests and procedures which included body temperature: fever that didn't go over 99.9f yesterday fahrenheit on 11Aug2021 fever that didn't go over 99.9F yesterday. The outcome of the events were unknown.    The lot number for the vaccine, [BNT162B2], was not provided and will be requested during follow up.
From telephone conversation with reporting nurse it was stated that a 4 year old patient  (1 of 2) was administered Tripedia, Lot UO532CA administration date not provided. Sometimes after the vaccination, the patient developed a large local reaction consisting of redness, swelling and warmth from shoulder to elbow area. Patient was seen in office. This case is linked to case # U2001-01014.
Information has been received from a physician concerning pt (between elementary school age and high school age) who was vaccinated with a dose of varicella virus vaccine live. In approx Nov 2005, between Nov and Dec 2005, the pt experienced breakthrough chickenpox. There were 20 lesions or less. Unspecified medical attention was sought. Subsequently, the pt was fine and recovered from chickenpox. No product quality complaint was involved. Additional information has been requested.
Pt multiple Painful oral ulcers Associated with low-grade temperature elevation but no true fevers, and associated with several episodes of emesis
Patient passed out after the vaccine....He had mentioned a history of vaso-vagel response when he got a shot as a teenager.  He was sitting for about 5 minutes then told us he didn't feel well, then passed out.  However, he came to very quickly.  He was given a cold compress, some water and was sitting with legs up.  We observed him for 45 minutes until he felt well enough to leave.  I don't think this was a problem with the vaccine due to a similar history while receiving a different vaccine in the past.
PT had vasovagal syncopal episode, couldn?t see, disoriented,.  Checked out by ALS, administered fluids, hypertensive. Transported ALS to Hospital.  Run # 58372
Pt states that about 45 minutes after receiving vaccine, they had a headache.  Then they do not remember much of the afternoon...almost like their mind was blank.  Pt did state that they have psychomotor seizures.    1) was driving across down but stopped car on the side of the road . Other people noticed the stopped car and tried to talk to her - no response (even though she seemed alert) 2) pt's husband found her trying to iron a shirt but instead of an iron she was using reading glasses. 3) cannot remember doing anything during the after noon.
Pt accidently given 0.3mL of air instead of vaccine.  Full pediatric dose given after.  Pt stable and released from the vaccination site.
pt recvd vax 13MAY92; 21MAY92 8 days post vax pt exp fever 101, rash w/itching; given APAP & used OTC cream for itching; fever for 4 days-rash itching still present;
Information has been received from a 67 year old consumer reporting herself with no pertinent medical history and no drug allergies or reactions who on 01-MAR-2011 was vaccinated with a dose of ZOSTAVAX (Merck) (lot # not reported). Concomitant therapy included metformin. The patient stated that on 01-MAR-2011 after received the ZOSTAVAX (Merck), the injection site swelled up and a hive developed. The patient was not given treatment. The patient did not seek medical attention. There was no labs or diagnostic tests performed. Upon the reported time, the patient was not recovered. No further information is available.
Initial information received on 08-Nov-2018 regarding an unsolicited valid non-serious case received from a physician. The case was linked with 2018SA312227 (same reporter). This case involves an about 50 years old patient (gender not reported) who received an expired dose of TYPHIM VI (batch number, expiration date, dose, route and site of administration was not reported) on 07-Nov-2018. The patient's medical history and concomitant medications were not reported. It was an actual medication error due to expired vaccine used. It was reported that the patient had no side effects. This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holder's compliance with the requirements set out in Directive 2001/83/EC and Module VI of the Good Pharmacovigilance Practices. The classification as a medical error is in no way intended, nor should it be interpreted or construed as an allegation or claim made by the marketing authorization holder that any third party has contributed to or is to be held liable for the occurrence of this medication error. List of documents held by sender: none.
Developing a red rash near the injection site. The rash is warm to the touch and has been steadily growing throughout the day.
Pins and needles, tingles in fingers, both hands, arms, and sometimes other parts of the body, including neck, feet. The sensation comes and goes multiple times per day, sometimes severe, and feels strong during the night / morning.
After influenza vaccine given on 10/8/2020 clients arm progressively became more and more sore to the point where the client could not lift their arm. Pain keeps client up at night.  Saw their PCP on 10/20/20 when a red spot was noticed and it was warm to the touch.  Client was told that the site is infected.
pt recvd flu vax & w/in 1/2 hr devel erythema, induration, & pruritus @ the site of inject; next day devel a fever & intense arthralgias, similar to serum sickness reaction; 28MAY92 pt cont to exp myalgias/arthralgias;
Started with usual post immunization soreness at vaccine site, but got progressively worse. By 9 months after the vaccine, I had lost significant range of motion in my upper arm and shoulder, as well as developed sharp shooting pains during certain arm movements.
Information has been received from a health professional concerning a 15 month old female with [[name]] white tag on left nipple who on 25-JUN-2009 was vaccinated with her first dose of VARIVAX (lot # 663947/0583Y) SQ into her left thigh. There were no illnesses at the time of vaccination. Concomitant therapy included her fourth dose of PREVNAR (unspecified) (lot # D63486) IM into her left thigh. On 25-JUN-2009 the patient experienced "lower left thigh some redness" and "two [[name]] welts." treatment and shortly after the vaccination. The physician labeled the chart "varicella allergy". No lab test was performed. The outcome of the patient's adverse was not reported. Additional information has been requested.
Same day and next day of injection - had some itchy, roughness on roof of mouth and lips. 11 days (8/31) after the injection had about a 3 inch oval around welt like spot at injection site that was red, puffy, warm and itchy.  4 days after that (15 after injection - 9/3) broke out in extremely itchy rash mostly on both arms but some on stomach and legs. The itchiness on roof of mouth and lips started again.    Applied ice to injection site and took Benadryl - no immediate relief but went away after about 6 days. Rash - Benadryl did not help - applied rubbing alcohol for some itch relief.   Still have rash on arms as of 9/22 but itchiness improved and starting to dry up.
THE PATIENT WALKED UP TO THE CHECKOUT COUNTER AFTER RECEIVING HER SECOND DOSE OF MODERNA COVID-19 VACCINE AND THEN ASKED IF SHE COULD SIT DOWN BECUASE SHE FELT LIGHT HEADED.  ALMOST IMMEDIATELY, SHE SLUMPED OVER AND STARTED TO FAINT. A PHARMACY INTERN CAUGHT HER BY THE SHOULDERS TO HELP ENSURE SHE DID NOT HIT HER HEAD.  A TECHNICIAN IMMEDIATELY DIALED 911, AND THE PHARMACIST INJECTED HER IN THE THIGH WITH AN EPI PEN.  HER BLOOD OXYGEN LEVEL WAS TAKEN WITH PULSE OXIMETER, AND BLOOD PRESSURE WAS MONITORED WITH BLOOD PRESSURE CUFF.  AS THE PATIENT REGAINED CONSCIOUSNESS, SHE SAID SHE WAS HOT, SO WE GAVE HER A COLD TOWEL. THE PATIENT ALSO TOOK 50MG OF DIPHENHYDRAMINE LIQUID ORALLY.  PARAMEDICS TOOK OVER TREATMENT AND WE RELAYED ALL INFORMATION TO THEM.
12 hours - swollen and sore arm 24-36 hours - fever up to 103.4, chills, sweats
swollen at injection site; very uncomfortable; inflamed at injection site; 50% of body covered in a rash - His arms, thighs, back and going up his neck; This case was received via an unknown source (no reference has been entered for a health authority or license partner) on 23-Feb-2021 and was forwarded to Moderna on 24-Feb-2021.    This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE SWELLING (swollen at injection site), DISCOMFORT (very uncomfortable), VACCINATION SITE ERYTHEMA (inflamed at injection site) and RASH (50% of body covered in a rash - His arms, thighs, back and going up his neck) in a male patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     The patient's past medical history included No adverse event.    On 13-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 21-Feb-2021, the patient experienced VACCINATION SITE SWELLING (swollen at injection site), DISCOMFORT (very uncomfortable), VACCINATION SITE ERYTHEMA (inflamed at injection site) and RASH (50% of body covered in a rash - His arms, thighs, back and going up his neck). At the time of the report, VACCINATION SITE SWELLING (swollen at injection site), DISCOMFORT (very uncomfortable), VACCINATION SITE ERYTHEMA (inflamed at injection site) and RASH (50% of body covered in a rash - His arms, thighs, back and going up his neck) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.
Local reaction-red, warm, tender. No hardened areas or swelling. Taking ibuprofen and applying cool compress-> all symptoms are improving.
The pt experienced headaches, nausea, vomiting, chest pains, dehydration requiring IV hydration.