chrisvoncsefalvay/vaers-outcomes huggingface dataset:
24 hours of moderate shoulder pain on injection arm.; This is a spontaneous report from a contactable other health Care Professional for herself. A 48-years-old female patient received first dose BNT162B2 (solution for injection, Lot number: EL3247) via intramuscular route of administration on left arm on 22Jan2021 15:45 at single dose for COVID-19 immunisation. The patient medical history and concomitant medications were not reported. It was reported that the patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine, the patient was not received any other medications within 2 weeks of vaccination. The patient was not diagnosed with COVID-19 prior to vaccination. The patient experienced after first dose, 24 hours of moderate shoulder pain on injection arm, on unspecified date in Jan2021 and there was no event treatment for the event. the outcome of the event was not recovered; Sender's Comments: Linked Report(s) : US-PFIZER INC-2021194794 same reporter, patient and suspect drug; different dose and event
Pt states that evening after receiving PPV23 shot, he got a high fever, nausea, vomiting, then "slept for 2 days".  Developed a rash on opposite leg, and swelling of groin.  Went to another doctor and was prescribed hydrocortis cream.
Became Sick with fever and cough 6/25/22. Tested positive for Covid and flu A on 6/29/22.
On 1/29/03, pt presented to physician's office with redness and swelling to the right thigh that extended from upper thigh to knee area. Physician prescribed oral steroid and Benadryl. Pt to follow-up with physician today, 1/30/03. On 1/31/03, spoke with mom and pt is showing slight improvement.
Patient came into clinic to get Booster of moderna shot and record was pulled.  Patient accidently received booster 2 months early.
Arm pain immediately after the shot. 3:45 PM. Headache, eye soreness, sinus pain - 11:30 PM. Chills and shakes - 2:30 AM. Sweats - 4 AM. Continued tiredness throughout the day.
EUA COVID 19 Vaccine Moderna  Hospitalized for GI bleed, hypotension and weakness
about 3hr p/vax broke out w/hives & had swelling of hands & feet;17MAR swelling cont;20MAR has seen MD on 19MAR97;cont to have inc signs & sx of joint, gum, neck swelling & diff breathing;took med;
DIFFERENT KINDS OF PAIN EVERY DAY; This spontaneous report received from a patient via a company representative concerned a patient of unspecified age and sex. The patient's weight, height, and medical history were not reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin, and batch number were not reported) dose, start therapy date were not reported for covid-19 prophylaxis. The batch number was not reported. Per procedure, no follow-up will be requested for this case. No concomitant medications were reported. On an unspecified date, the patient experienced different kinds of pain every day. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from different kinds of pain every day. This report was non-serious.
has been told "they gave the vaccine too low in the arm it is about 5 inches down from my shoulder"; muscle at injection site has been red and swollen and is ongoing; muscle at injection site has been red and swollen and is ongoing; This spontaneous case was reported by a consumer and describes the occurrence of INCORRECT ROUTE OF PRODUCT ADMINISTRATION (has been told "they gave the vaccine too low in the arm it is about 5 inches down from my shoulder"), VACCINATION SITE SWELLING (muscle at injection site has been red and swollen and is ongoing) and VACCINATION SITE ERYTHEMA (muscle at injection site has been red and swollen and is ongoing) in a 72-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 011A21A and 29K20A) for COVID-19 vaccination.     No medical history was provided by the reporter.  Concomitant products included VITAMIN D [VITAMIN D NOS], METFORMIN, ATORVASTATIN CALCIUM (LIPITOR), LOSARTAN and ACETYLSALICYLIC ACID (BABY ASPIRIN) for an unknown indication.   On 04-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 04-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 04-Mar-2021, the patient experienced INCORRECT ROUTE OF PRODUCT ADMINISTRATION (has been told "they gave the vaccine too low in the arm it is about 5 inches down from my shoulder"), VACCINATION SITE SWELLING (muscle at injection site has been red and swollen and is ongoing) and VACCINATION SITE ERYTHEMA (muscle at injection site has been red and swollen and is ongoing). On 04-Mar-2021, INCORRECT ROUTE OF PRODUCT ADMINISTRATION (has been told "they gave the vaccine too low in the arm it is about 5 inches down from my shoulder") had resolved. At the time of the report, VACCINATION SITE SWELLING (muscle at injection site has been red and swollen and is ongoing) and VACCINATION SITE ERYTHEMA (muscle at injection site has been red and swollen and is ongoing) had not resolved.            No treatment medications were reported.   Most recent FOLLOW-UP information incorporated above includes: On 04-Aug-2021: Follow-up received provided no new information. On 25-Sep-2021: Follow-up received includes no new information.
Angioedema limited to R lower lip,  no intraoral involvement. Positive hx of same with ACE/ARB in the past.
INJECTION SITE REACTION:  PAIN AND INFLAMMATION STILL FROM 11/17/22
Rec'd 2 mo imm 10/22/13; pink maculopapular rash to scalp, neck, arms, trunk/back and buttocks. Developed that PM seen for s/s 10/23/13. Also noted on exam rash with cutis marmorata. *Appears to be viral; no TX; referred to I.D and Allergy.
MD reported that pt recvd vax 31JAN91 & approx 10FEB91 devel a rash & a fever from which pt recovered; approx 14FEB91 exp a balance problem; pt recovered in 2 to 3 days; No further details were provided;
Swelling of the face; rash on face and left arm; This is a spontaneous report from a non-contactable consumer (patient). A 79-year-old male patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE Solution for injection), via an unspecified route of administration, administered in the left arm, on 17Feb2021 15:00 (Batch/lot number: EL9266), at age 79 years old, as dose 1, single. Relevant medical history was reported as none. The patient did not have COVID-19 prior to vaccination and was not tested for COVID-19 post vaccination. The patient has no known allergies. Concomitant medications were not reported. The patient did not receive other vaccines in four weeks. On 20Feb2021, the patient experienced swelling of the face and rash on face and left arm. The events resulted to doctor or other healthcare professional office/clinic visit. Treatment for the events included steroid pills and vitamin D shot. The patient was recovering from the events.   No follow-up attempts are possible. No further information is expected.
Patient had noted reactions from the Polio vaccince at age 8.  Asked about the specific reactions, told she became very dizzy.  Asked questions to rule out any need for possible anaphylaxis, ruling out possible need of needed EPI Pen readiness.  Immediately upon injection, began to get dizzy.  Patient quickly became dizzy to the point of fainting.  At that time, another pharmacist came to assist holding patient upright.  Associate instructed to call 911.  Ambulance arrived and documented previous description of adverse reaction.  Patient transported to Hospital for full evauluation.
Rt. zygoma; 2nd degree - 0.5 cm. Redness, pain (10/10 per pt.); mild swelling at injection site x 48 hours (per emergency room report included with this form).
After 2nd shot, experienced constant ringing in my right ear.  Saw an ENT, who diagnosed Tinnitus. Since ringing started after the second Pfizer shot, and I have never experienced these symptoms before, the doctor and I believe this is related to receiving the Pfizer covid vaccine.
first dose on May 11th 2022 planning to receive second on Jun 29th 2022; This case was reported by a pharmacist via call center representative and described the occurrence of incomplete course of vaccination in a patient who received HBV (Engerix B) for prophylaxis.   Concomitant products included HEPATITIS B VACCINE (ENGERIX B).   On an unknown date, the patient received the 2nd dose of Engerix B. On an unknown date, unknown after receiving Engerix B, the patient experienced incomplete course of vaccination. On an unknown date, the outcome of the incomplete course of vaccination was unknown.   Additional Information: GSK receipt date: 15-June-2022 Reporter's comment: The pharmacist asked how to proceed if the patient was late for Engerix-B second dose.  The first dose was on 11th May 2022 but due internal issues, they were planning to received Engerix-B second dose on 29th June 2022.  The reporter did not consent to follow-up.  Additional Supportive Information: Till the time of reporting the patient did not received 2nd dose which led to incomplete course of vaccination. This is one of 5 cases reported by same reporter.; Sender's Comments:  US-GLAXOSMITHKLINE-US2022AMR093987:Same reporter US-GLAXOSMITHKLINE-US2022AMR093988:Same reporter US-GLAXOSMITHKLINE-US2022AMR093989:Same reporter US-GLAXOSMITHKLINE-US2022AMR093990:Same reporter
Pinkish 2"x3" mild local reaction at site (L) lateral arm - resolving at time of visit.
Painful leg muscle cramping.  Began in right calf.  Spread to both legs and feet by 4:00 p.m..  Stretching did not relieve.  Ibuprofen did not relieve.  Used heating pad in bed  9:00 p.m.  Pain subsided about 11:00 p.m.
achiness; headache; This spontaneous case was reported by a consumer and describes the occurrence of MYALGIA (achiness) and HEADACHE (headache) in a 61-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 012A21A and 004M20A) for COVID-19 vaccination.     No medical history information was reported.  Concomitant products included MIRTAZAPINE (REMERON) for Anxiety, ATORVASTATIN CALCIUM (LIPITOR) for Cholesterol, CALCIUM, COLECALCIFEROL (CALCIUM +VIT D) for an unknown indication.   On 02-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 03-Apr-2021, 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 experienced MYALGIA (achiness) and HEADACHE (headache). At the time of the report, MYALGIA (achiness) and HEADACHE (headache) had resolved.            No treatment medication was provided  The patient received both scheduled doses of mRNA-1273 prior to the events; therefore, action taken with the drug in response to the events is not applicable.   This case was linked to MOD-2021-024158 (Patient Link).
Treatment of COVID-19; Treatment of COVID-19; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 50-year-old female patient (not pregnant) received bnt162b2 omi xbb.1.5 (COMIRNATY (2023-2024 FORMULA)), on 15Oct2023 at 16:30 as dose 1, single (Batch/Lot number: unknown) at the age of 50 years, in left arm for covid-19 immunisation. The patient's relevant medical history included: "Hashimoto's thyroiditis" (unspecified if ongoing); "Diabetes mellitus" (unspecified if ongoing). The patient's concomitant medications were not reported. Vaccination history included: Covid-19 vaccine (DOSE 1; MANUFACTURER UNKNOWN), for COVID-19 immunization; Covid-19 vaccine (DOSE 2; MANUFACTURER UNKNOWN), for COVID-19 immunization; Covid-19 vaccine (DOSE 3 (BOOSTER); MANUFACTURER UNKNOWN), for COVID-19 immunization. The following information was reported: VACCINATION FAILURE (medically significant), COVID-19 (medically significant) all with onset Nov2023, outcome "recovered" (Nov2023) and all described as "Treatment of COVID-19". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (16Nov2023) Negative. Therapeutic measures were taken as a result of vaccination failure, covid-19 with Paxlovid from 09Nov2023 to 14Nov2023. Clinical course: Patient had no known allergies.  The information on the batch/lot number for bnt162b2 omi xbb.1.5 has been requested and will be submitted if and when received.; Sender's Comments: Linked Report(s) : US-PFIZER INC-202300384631 Same patient, different product, different dose/event;
Flu like symptoms, fever, urinary tract infection symptoms of having to urinate frequently but no pain or blood, right side of back hurt like it did a few weeks before shot when I had fluid in my lung
pt had a sz condition, stopped breathing & was taken to hosp;pt was limp & didn't respond;pt still shakes @ times when sleeping;pt had a fever & they said there was no tx;
From information received on 12/04/2002, it was reported that a 2 month old female patient was vaccinated with first dose of TRIPEDIA (Lot # U582AA) given intra-muscularly in the right thigh, ACTHIB (Lot # UA735AA) given intra-muscularly in the right thigh, IPOL (Lot # W00632) given intra-muscularly in the left thigh and HEPATITIS B VACCINE (manufacturer Merck Lot # 0513M) given intra-muscularly in the left thigh at 11:00 AM on 12/02/2002.  TRIPEDIA was administered within a 2 week span, from the same lot numbers as 4 other children.  At 12:00PM on the same day as vaccination, the patient experienced redness and swelling at the injection site and unconsolable crying lasted 2-4 hours.  The patient was not taking any other medication at time of vaccination.  No other vaccines were given within 4 weeks of vaccination date.  It is not reported whether the patient recovered.  The case is closed.
Dizziness and chills/fever began the evening of the shot Dizziness and nausea continued the next day
Headache, chest tightness, chest pain, shortness of breath, cough, internal swelling, limb swelling, face swelling, joint pain!
Jaw pain, back pain, heavy chest pain.  Lasted 3 days, had to check into hospital on 4th day.
Information has been received from a nurse concerning a 17 year old female who on 29 Nov 2006 was vaccinated with the second dose (first dose date not reported) Gardasil (Lot 653938/0954F). Concomitant therapy included Adderall tablets and Zoloft. On 30 Nov 2006 the patient experienced dizziness, a bad taste in her mouth and a headache. It was reported that the patient was able to attend school that day. The patient's dizziness and bad taste and headache persisted. It was noted that the patient did not have adverse events after her first dose of Gardasil. The patient sought unspecified medical attention. Additional information has been requested. Follow up information received from a nurse practitioner stated that the vaccination that the patient received on 29-NOV-2006 intramuscularly in her right deltoid was the first dose of GRDASIL (Lot# 653938/0954F), not the second as previously reported. It was also reported that the patient had recovered from the dizziness and bad taste in her mouth. Additional information not requested.
Treatment of COVID-19; Treatment of COVID-19; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 48-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 15Sep2022 as dose 1, single (Lot number: W5342) at the age of 48 years, in right arm for covid-19 immunisation. The patient's relevant medical history included: "Asthma" (unspecified if ongoing), notes: Other medical history: Asthma; "Known allergies: Latex" (unspecified if ongoing). The patient's concomitant medications were not reported. Past drug history included: Known allergies: codeine, reaction(s): "Drug Allergy". The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant), outcome "unknown" and all described as "Treatment of COVID-19". Therapeutic measures were taken as a result of drug ineffective, covid-19.
Patient felt dizzy after Pfizer COVID-19 vaccine and was moved to recover room with EMS. Blood pressure was elevated as below:  11:10 - BP 154/107, Pulse 90 11:25 - BP 148/94, Pulse 86  Patient was observed for 30 minutes. After 30 minutes, patient was released with his companion back to his house.
Complaint of sore/scratchy throat, headache, runny nose/congestion, loss of taste/smell and diarrhea.
Patient received Tdap vaccine during routine physical exam. At check out, patient felt dizzy and fainted. Assessment was fine after syncopal event.
pt recvd vax & devel redness, warmth & itching in the arm of inject; react lasted 1-2 days
Pt recv vax on 11/9/98; on 11/16/98 pt exp rash on trunk; tx=Benadryl & Calamine
This spontaneous report as received from a nurse refers to a patient of unknown age and gender. The patient's medical history, concurrent conditions and concomitant medications were not reported. On 19-MAR-2015, the patient received a dose of expired ROTATEQ, lot # J008364, expiration date 27-Feb-2015, 2 ml, orally. Dose was supported. It was unspecified which dose number in the series this vaccination was. No adverse experience reported. Additional information has been requested.
2-3 days after Varivax he developed increasingly severe midback pain. No fever or other sx. Pain was bilateral mid thoracic. Lungs clear, CXR OK. Patient still has disabling pain, requiring analgesics.
Pruritus, redness, elevation on back of (L) arm on 9/23/11. By reference of mother the inflammation have diminished. Area hard to touch: diameter 1/2 inch, no redness. On S/Q tissue.
8 days after receiving the J&J vaccine, I experienced a numbness, tingling in my left foot as I went to bed that night. Over the course of the next month, it spread to my left calf and left quadricep. There are days it remains just a zinging and other days where my left leg feels heavy, like I don?t have control over it or maybe it is paralyzed. Per my doctor?s advice, I waited a month after being vaccinated to see if the symptoms abated. Instead it got worse. Made an appointment with Dr. May 23, 2021.
Initial report received from health care professional on 15 Dec 2009: One dose of S-OIV FLUVIRIN was drawn into syringe. This syringe with attached needle was used to inject 0.5 ml dose of S-OIV FLUVIRIN (batch no. 102139P1) into the deltoid of this patient on 15 Dec 2009. Once the needle was withdrawn from the tissue, the reporter noticed that a small, unspecified volume of vaccine ran down the patient's arm. No adverse effect was reported.
This spontaneous report was received from a Nurse, referring to a 19 year old patient. The patient's pertinent medical history, concurrent conditions and concomitant medications were not provided. On 13-SEP-2017, the patient was vaccinated with a pediatric dose of VAQTA lot # N017094 with expiration date on 31-AUG-2018 (strength and dose were not mentioned) for prophylaxis. At the reporting time no adverse event was reported.
The patient states his left arm started itching last night, then reddened and was warm. The patient's left arm now feels stiff.
Has clinical chickenpox approximately 30 lesions on extremities, neck. No fever. No other symptoms. Rash appeared 06/25/02.
Patient fainted approximately 20 minutes after covid (pfizer) immunization. EMS was called but patient was able to walk and was lucid. Patient did not take ambulance and went home on his own will. Patient ultimately stated that he was fine and did not require medical treatment.
Shot administered Thursday, March 18th 1. Today (Sunday, March 21) I am able to lift my arm again (see #2 for arm pain) and in the shower realized the lymph node in my left armpit close to the injection side is very swollen and dense.  Right armpit lymph node is fine and difference is visually noticeable.  If by morning it has not gone down I will call my doctor, I don't feel it's bad enough to go to an ER on a Sunday night. 2. Day after shot (Friday, March 19), waking up the injection site was incredibly sore, beyond a what a normal shot causes (with the exception of the tetanus shot, similar pain).  I have been taking ibuprofen for pain, but having a hard time sleeping continuously, as waking up in pain.  Today (Sunday, March 21), pain has gone from what was severe to mild-moderate.  Still hurts if it gets touched, but I can now lift my arm without severe pain. 3. Headache since injection.  Similar headache to when I had Covid in December, but probably 50% as bad, so able to deal.  Still have headache, but not as bad as the day after the shot.
Pt vaccinated with DTP/OPV developed "hives" at site of injection, stomach, legs, thighs & buttocks few on face. Hives were gone by 15DEC90.
Hive on left wrist, immunization give in left arm. 4mg chlorpheriramune give.
Tachycardia/HR going up to 140 /minute; Blood pressure went up to 157/94; This is a spontaneous report from a contactable physician (patient himself). A 59-year-old male patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, lot number and expiry date were unknown) via an unspecified route of administration (left arm), on 21Dec2020 at 16:30, at a single dose, for COVID-19 immunization. Relevant medical history included coronary artery disease (CAD) prior percutaneous coronary intervention (PCI) in 2004. The patient has no known allergies. Concomitant medications in two weeks included aspirin, ramipril, ezetimibe, simvastatin (VYTORIN), vitamin D3, and diclofenac. The patient did not receive any other vaccines within 4 weeks prior to COVID vaccine. Prior to vaccination, patient was not diagnosed with COVID-19. The vaccine was administered in the hospital. On 21Dec2020, within 3 minutes of receiving the vaccine (at 16:45), the patient developed tachycardia with heart rate (HR) going up to 140 /minute and blood pressure went up to 157/94. Heart rate returned to 90s within few minutes while his blood pressure slowly returned to baseline 134/84 after 2 hours. The patient did not receive treatment for the events. The patient recovered from the events on the same day (21Dec2020). Since vaccination, the patient has not been tested for COVID-19.  Information on the lot/batch number has been requested.
Acute arthritic attack involving temporary inability to move my right arm. swollen and bruising in my right hand.  Swelling only in the left hand.  Six days of prednisone without relief. Two weeks later six weeks of prednisone. In this process now.
abscesses on her gums/abscess on her gums now; This spontaneous case was reported by a consumer and describes the occurrence of GINGIVAL ABSCESS (abscesses on her gums/abscess on her gums now) in a 60-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 042B21A and 003B21A) for COVID-19 vaccination.     No Medical History information was reported.   On 01-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 29-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. In July 2021, the patient experienced GINGIVAL ABSCESS (abscesses on her gums/abscess on her gums now) (seriousness criterion medically significant). The patient was treated with Surgery (Root canal) for Gingival abscess. At the time of the report, GINGIVAL ABSCESS (abscesses on her gums/abscess on her gums now) had not resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   Concomitant medications details were not reported by the reporter. Treatment details was not reported by the reporter.; Sender's Comments: This case concerns a 60-year-old, female patient with no relevant medical history, who experienced the unexpected event of gingival abscess. The event gingival abscess occurred approximately 3 months after the second dose of mRNA-1273 vaccine administration. The rechallenge was unknown as there's no information available about the first dose. The benefit-risk relationship of mRNA-1273 vaccine is not affected by this report.