chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Patient developed rash on both arms 3 days after the vaccination.  It lasted for 2 weeks.; This is a spontaneous report from a contactable consumer (parent). A 14-years-old female patient received first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, Lot Number: EN5318), via an unspecified route on unspecified date (at the age of 14-years) as dose 1, single in the left arm for covid-19 immunisation. The patient medical history included Known allergies: penicillin and some sunscreens. The patient concomitant medications were not reported. The patient did not receive any other vaccines within four weeks prior to the vaccination. The patient did not receive any other medications within 2 weeks prior to the vaccination. Prior to the vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. The patient experienced rash on both arms 3 days after the vaccination on 15May2021. It lasted for 2 weeks. Patient did not received treatment for events. The outcome of the events was recovered on May2021.  Information on Lot/Batch number was available. Additional information has been requested  Follow-up attempts are completed. No further information is expected.
This spontaneous report was received from an other health professional (nurse) refers to a patient of unknown demographics. Patient's pertinent medical history and drug allergies were not reported. On 08-DEC-2014 the patient was vaccinated with one dose of ROTATEQ (dose, frequency, lot #, expiry date unspecified) that was exposed to an unsupported temperature excursion. No concomitant medications were reported. No adverse effect was reported. No product quality complaint (PQC) was reported. Causality was reported as not related to therapy with ROTATEQ. This is one of several reports received from the same source (MARRS # 1412USA005251). Additional information has been requested.
Patient presented as a walk-in to Covid Vaccine Clinic for direction regarding receiving second Moderna vaccine.  Per patient, received first Moderna vaccine 9/2/2021 at pharmacy in her left arm. Reports during first week after injection that ?site where needle went in was a little sore.?  Reports last week upper right arm ?was really swollen and much sorer? than in the previous week. Reports edema in area decreasing, Yesterday she noticed large (5 x5 or larger) area of redness in right upper arm that feels ?hot with a burning sensation.? She denies having the following at any time since Covid vaccine administration: fever, SOB (has COPD ? no changes), rash / hives any other problems. Patient encouraged to call her PCP today for evaluation of arm and to discuss with MD if should receive second Moderna vaccine. Patient states she will call physician as soon as she returns to her car. Consult with RN regarding above and she concurs with plan. If MD approves second dose, encouraged client to obtain that in writing to take with her to clinic where will receive second vaccine dose. At this time, client states she doesn?t believe she will take the second dose.
Within 4 hours of both the first and the second vaccine injection, I experienced scratchy throat,  cough, and running nose
Approx. 8 hours after injection started having body aches within an hour developed a fever and became very lethargic. at midnight fever had reached 103, severe body aches and cold chills, used tylenol to lower fever but it continued up to 104. severe joint pain and when trying to walk had no muscle control. fever finally broke at 6pm the following day also experienced bright red face and headache.
Admitted to the hospital on 2/1/2022 with c/o cough, worsening SOB, please refer to H & P for details  Immunocompromised patient admitted for pneumonia due to COVID-19.  Seen by, Infectious Disease and completed course of IV remdesivir, and will complete course of steroid and empiric antibiotic at home.  No secondary bacterial infection/pneumonia.  Suspected lung metastasis, patient already established with Oncology and will be following up with Dr.
Pain in the biceps (shot location) when contracted or pressed; pain level was not high enough to obstruct arm movement, but discouraged. The pain faded away after two days.; This is a spontaneous report from a non-contactable consumer, the patient. A 27-year-old non-pregnant female patient received first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: 30155BA) via an unspecified route of administration in the left arm on 18Oct2021 (at the age of 27-years-old), as a single dose for COVID-19 immunisation. Medical history included allergy (unspecified). The patient received unspecified medications within two weeks of vaccination. Prior to vaccination, the patient was not diagnosed with COVID-19. The patient did not receive other vaccines within four weeks prior to the COVID vaccine. On 18Oct2021, the patient experienced pain in the biceps (shot location) when contracted or pressed; pain level was not high enough to obstruct arm movement, but discouraged. The pain faded away after two days. The event did not result in doctor or other health care professional office/clinic visit, and emergency room/department or urgent care. Therapeutic measures were not taken as a result of the event.  Since the vaccination, the patient had not been tested for COVID-19. The clinical outcome of the event pain in the biceps (shot location) when contracted or pressed was resolved on 20Oct2021.  No follow-up attempts are possible. No further information is expected.
pt recvd vax & devel lump at inject site accompanied by scabbing & bleeding; pt tested neg for hepatitis b surface antibodies;
One wk after vaccine, developed a 1/2 dollar size rash at injection site, reported a little itchy. MD prescribed Abx, pt unable to take BENADRYL and rash spread down to elbow one day later. By 5/13/17 she said rash is almost gone.
6APR92 recvd 1st dose of Engerix-B & w/in 48 hrs became deathly sick, passed out had chills & nausea; went to MD & recvd tx of unk nature; sx lasted about 2 wks;
Histamine Release Reaction, swelling, red welt L deltoid area, treated with Zyrtec for 3 days and cold compresses
From initial info received on 6/21/04 from the pt, regarding an adverse event occurring in the USA, it was reported that the 37 year old female pt received TD ADS Adult vaccination, lot U1184AA, IM, in the left arm on 6/14/04. Immediately following the vaccination, the pt developed chills and sweating without fever, had insomnia and observed "strange marks" on her hand, arms and feet. She reported the events to her physician by telephone, but has not yet been seen by her physician. The pt's recovery status is currently unknown. From additional info received on 9/21/04 from the responsible physician, it was reported that the pt had anxiety and finger laceration at the time of vaccination and was on concomitant therapy with Zyprexa. The physician reported that she saw the pt in her office on 6/16/04, 2 days after she had received the vaccination. At that time, the pt complained of fatigue, myalgias and night sweats since receiving the vaccine and reported to the physician that she had a similar reaction to Valium, with  a rash also, in 3/04. On 6/23/04, the physician removed 4 stitches from the pt's left fourth finger. The physician did not observe a rash at that time. On 7/9/04, the pt complained of insomnia, fatigue, anxiety and chills since her vaccination 3 weeks prior. She complained of "pits on her face" and rashes that came and went on her extremities, but were not viable upon the physicians exam. At that time, the pt was also being seen by her therapist for anxiety and delusions. It was not reported whether the pt had a history of delusions. The physician stated that she had not seen the pt since 7/19/04. It was not reported whether the pt recovered from these events. No further ino is anticipated, this case is considered closed.
sinus infection; This spontaneous case was reported by a consumer and describes the occurrence of SINUSITIS (sinus infection) in a 66-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     Concurrent medical conditions included Blood pressure abnormal, Parkinson's disease, Nerve pain and Cardiac disorder NOS.    On 03-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced SINUSITIS (sinus infection). At the time of the report, SINUSITIS (sinus infection) outcome was unknown. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Concomitant medications sleep pill and medications for the indications for blood pressure, parkinson's disease, nerve pain, heart conditions.  No treatment medications were reported
Large red knot growing daily since shot. The red know is hot, itchy, sore, and is not directly on injection site. The knot started slightly above the injection site.
Around 4:18AM on 3/29/21, I remember waking up super thirsty.  I jumped out of bed and walked into the kitchen.  I don?t remember anything after that.  However my motion security camera recorded me then falling back onto the hardwood floor hitting the back of my head.  I then went into a seizure banging my head on the floor 5x, body convulsing until it knocked me out cold.  I lay still about 7 seconds then slowly lifted up my head.  This was about 30 seconds in total and the camera stops recording after 30 seconds.  I didn?t realize what had happened at all for the next couple days.  I woke up in the morning with a splitting headache and seeing stars and floaties in my vision.  The light was insanely painful.  I canceled my work, stayed in bed.  Next day I tried walking to the tanning salon I go to every week one block from my apt.  I got lost walking there.  At that point I realized something was terribly wrong and went thru my security camera notifications to find the video of what happened.  I freaked out, went to nurse clinic, showed video she sent me to emergency room,  showed video they ran a bunch of tests I don?t recall and eventually sent me home with follow up orders for GP.  I was never able to get in to GP and was bounced around a lot of Drs getting care and follow up.  This was right when Hospitals reopened to patients after Covid lockdowns and local hospital was insanely busy.  Not the best follow thru and it took a long time to see neurologist and get results back.
Woke up with FLU LIKE  symptoms the morning after the injection ( Chills,  body ache, debilitated all day long)
Head pain right hemisphere within two hours, very similar but less intense as to when I recovered for months from long covid. Muscle pains and aches however no fever, runny nose as well. Brain fog off and on along with overall tiredness. All similar to two time I had COVID and recovered from long covid. Also dizziness when getting up and slight loss of balance time to time. Spacey awareness.
This spontaneous report as received from a pharmacist refers to a patient of unknown age and gender. No concurrent condition, medical history or allergy/drug reactions were reported. On 31-DEC-2015 at 14:32, the patient was vaccinated with improperly stored RECOMBIVAX HB with lot number: L025738, expiry date: unspecified (dose and strength unspecified). No concomitant medications were reported. No adverse effects were reported. The high and low temperature were 8.6 and 7.4 (units unspecified) respectively. There were no product quality complaints (PQC) involved. No additional information was provided. This is one of the several reports from the same reporter. Additional information has been requested.
Developed fever, vomiting and watery diarrhea. Still hospitalized currently (7/13/2015). (dont have exact time of onset)
SPOUSE CALLED APPROXIMATELY 4 HOURS AFTER VACCINATION AND REPORTED THAT PATIENT WAS EXPERIENCING NAUSEA AND VOMITING;
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 72-year-old male patient received bnt162b2, bnt162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), on 20Sep2022 as dose number unknown, single (Lot number: GJ5342) at the age of 71 years, in left arm for covid-19 immunisation; bnt162b2 (BNT162B2), on 04Apr2022 as dose number unknown, single (Lot number: FH8028), in left arm for covid-19 immunisation. The patient's relevant medical history included: "Barrett's esophagus" (unspecified if ongoing). The patient has no known allergies. The patient's concomitant medications were not reported. It was unknown if the patient has medication in 2 weeks. 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. The patient was given PAXLOVID from 15Sep2023 to 19Sep2023.
patient complained of feeling "tingly and off".  At 1610, BP 173/109, pulse 50, 100% on room air,  EKG in the field WNL. Denied headache and chest pain.  Rested for 30 min. BP 183/105 at 1637.  Patient reported feeling normal and agreed to follow up with primary MD or go to ER if symptoms worsened.
Ct. called to inform Health Dept that she had an allergic reaction after PPSV23 vaccine on 3-1-17, her left arm was sore, swollen and redden. It was hot to touch. Applied ice. On 3-2-17 c/o headache and felt off balance. Walked into her Dr. office. Dr. who examined and gave her a shot which she thinks it was an antibiotic but not sure. Was started on KEFLEX q 6 hours PO. 3/3/17 gotten worse and increased was swollen down to the elbow. She was a direct admit to hospital. Treated for cellulitis. Started on IV vancomycin which she had an allergic reaction with hives and itchiness. Switch to KEFLEX IV. Discharged on 3/5/17.
The day of the vaccine, I was extremely exhausted. Overnight the first night following the vaccine, I got really back joint pain. The next day I was nauseous and had a pinpoint itchy rash all over my body. Now, 49+ hours after the vaccine, the exhaustion and joint pain are gone but nausea and rash remain.
Child seen 11/14/05 at health department and 2 month shots given. 9 days later (11/23/05) child found dead in his crib by his mother. Child had some congestion prior to death. 8/4/06 Received autopsy report which revealed COD as acute tracheobronchitis with otitis media/ss
1 wk p/vax mild sx knees, hips, low back (lumbar) aching & stiffness;p/2nd dose sx significantly worse & on going 7/6/99;
Pt was to receive MMR, varicella, and HIB vaccinations on this date. Pt instead received Proquad, varicella, and HIB vaccinations. Pt tolerated well with no adverse reaction either at time of injection or at any time to date. Pt's mother will be notified by provider.
Swelling under left arm. Started small, expanded. Hard knot.  Occasionally tender. Doctor has order an  usaxilla left underarm (ultrasound, echogram)
Trigger asthma symptoms; headaches - I noticed headaches the next day; On Wednesday I had a really bad one all day. The headache kept going until I went to ER (sent me there said they couldn't treat me at Urgent Care) on Friday when my breathing was getting very compromised - pain in my right lung on Thursday and Friday and It felt like I had a really bad bronchial infection. Before I went to ER - I was using my inhaler all the time - 4-6 times a day (14th, 15th, 16th and the first half following the ER visit.) No other treatment - they said just follow up with Primary care or Pulmonologist.  After my ER visit, I used my inhaler for the first half of the week and then it started getting better and also the environment was having less pollen and so that was improving as well.
Started rash late Saturday the 20th or early Sunday the 21st. Small bumps over both cheeks. The bumps do not currently hurt or itch.
COVID-19; COVID-19; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). Other Case identifier(s): 2022NVX-US-000003553 (Novavax). A female patient received BNT162b2 (BNT162B2, Lot #: Not reported, Exp. Date: Not reported), in May2021 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: DRUG INEFFECTIVE (medically significant), SUSPECTED COVID-19 (medically significant), outcome "unknown" and all described as "COVID-19". Adverse event information: On 19Sep2022, it was reported that a patient started treatment on an unreported date in May2021 with Pfizer-BioNTech COVID-19 Vaccine at an unspecified dose/frequency for an unspecified indication. It was reported the patient got COVID-19.   The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.
Administration of vaccine past 30 days in the fridge; This spontaneous case was reported by a physician and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Administration of vaccine past 30 days in the fridge) in a 28-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 035C21A) for COVID-19 vaccination.     No Medical History information was reported.   On 30-Jul-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 27-Aug-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 27-Aug-2021,  after starting mRNA-1273 (Moderna COVID-19 Vaccine), the patient experienced EXPIRED PRODUCT ADMINISTERED (Administration of vaccine past 30 days in the fridge). On 27-Aug-2021, EXPIRED PRODUCT ADMINISTERED (Administration of vaccine past 30 days in the fridge) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   It was reported that the vials were stored in the refrigerator on 03-May-2021 and administered on 27-Aug-2021.  Concomitant medications were not reported.  Treatment medications were not reported.   Most recent FOLLOW-UP information incorporated above includes: On 01-Oct-2021: Follow up received and added first dose date.
Got the shot and got internal shingles/ suspected vaccination failure; Got internal shingles; This serious case was reported by a consumer via interactive digital media and described the occurrence of vaccination failure in a patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   On an unknown date, the patient received Shingles vaccine. On an unknown date, an unknown time after receiving Shingles vaccine, the patient experienced vaccination failure (Verbatim: Got the shot and got internal shingles/ suspected vaccination failure) (serious criteria GSK medically significant) and shingles (Verbatim: Got internal shingles). The outcome of the vaccination failure was unknown and the outcome of the shingles was not reported.   It was unknown if the reporter considered the vaccination failure and shingles to be related to Shingles vaccine.     It was unknown if the company considered the vaccination failure and shingles to be related to Shingles vaccine.   Additional Information: GSK Receipt Date: 31-MAR-2023 This case was reported by patient via interactive digital media. The patient got the shot and also got internal shingles.  They come and go frequently. This case was considered as suspected vaccination failure since the details regarding the completion of primary vaccination schedule, time to onset and laboratory confirmation of shingles were unknown at the time of reporting. Follow up was not possible, as no contact details were available.
Received vaccine 1/13/21 at 10:30 am. Felt fine all day. Woke up next day 1/14/21  at 5 AM with fever 101.0, body aches, dizziness, fatigue enlarged lymph node at left axilla, same side as shot, mild nausea, and a sore left arm. Felt sick for about 12 hours with these symptoms, fever resolved slowly with ibuprofen. Symptoms mostly resolved in 24 hours, except I still have an enlarged lymph node - left axilla with throbbing pain. No fever.
POTS symptoms, dizziness, lightheadedness, tachycardia, chronic fatigue, heat intolerance, sweats, hot flashes, shortness of breath, difficulty breathing
The patient noted an area of erythema and induration at the injection site on the night of 1/19/2021 after receiving first dose on 1/11/2021. Area has increased in size. She was referred to her PCP.
He is losing some taste/but reduced by 30-40%; received first dose of vaccine 21DEC2020 and SARS-Cov-2 positive/Nasal swab COVID positive; received first dose of vaccine 21DEC2020 and SARS-Cov-2 positive/Nasal swab COVID positive; Sniffles; This is a spontaneous report received from Pfizer sponsored program Pfizer First Connect via a contactable other HCP (parent) reported for the patient (son). A 22-years-old male patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) (lot: EK5730) intramuscularly in left arm on 21Dec2020 (15:00-16:00) at single dose for COVID-19 immunisation. There was no medical history. There were no concomitant medications. The patient received first dose of vaccine 21Dec2020 and SARS-Cov-2 positive 06Jan2021 13:00. The patient got COVID vaccine 21Dec2020, and was scheduled to get second dose on 11Jan2021. He had a sniffle the other day on 05Jan2021 night time and tested positive for COVID on 06Jan2021, so reporter wanted to know if he should still get second dose. His symptoms are stable. He is quarantining. He is on his way to do a PCR now. Reporter read somewhere people could have false positive in nasal. He is losing some taste from 07Jan2021 (01:00 - 02:00). Most things he can taste. Some he cannot. It is not completely gone but reduced by 30-40%. He did a mouthwash with a sting and is not feeling that sting anymore. He said last night, same thing. He did a mouth wash and did not really taste much. It is not as prevalent as it was before. The patient underwent lab tests and procedures which included SARS-CoV-2 test: positive on 06Jan2021, positive COVID test 06Jan2021, 13:00, Nasal swab COVID. Event outcome of sniffles was recovering, while for other events was unknown.; Sender's Comments: The efficacy of a drug varies from one patient to another and can be affected by different factors; however, a contributory role of the suspect drug BNT162B2 to the reported event ___ cannot be ruled out. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to RAs, Ethics Committees, and Investigators, as appropriate.