chrisvoncsefalvay/vaers-outcomes huggingface dataset:
NONE - REPORTING ERROR: PATIENT RECEIVED A 0.3ML DOSE OF PFIZER VACCINE THAT WAS MIXED WITH 0.8ML OF SALINE RATHER THAN 1.8ML OF SALINE, HUMAN ERROR ON PHARMACY PART OF PERSONNEL RECONSTITUTING VACCINE; PATIENT INFORMED ON 05/26/21 2:28PM OF VACCINE ERROR AND INSTRUCTED TO WATCH FOR ABNORMAL OR GREATER THAN NORMAL SIDE EFFECTS.
I woke up on Saturday morning with whole body soreness, but this passed by that afternoon.  Saturday night through to Sunday, I had chest pains on my entire left side.  This worsened all of Sunday and I developed dyspnea (shortness of breath) if I tried to lay down on my back or side along with the pain.  I could not sleep or rest Sunday to Monday night so I had to prop myself forward over a bundle of pillows in order to rest.  Monday I still had some pain though less, but the dyspnea was more pronounced with any moderate exertion.  I called the medical director where I work to ask for advice.  He told me it was ok to take an antihistamine.  I had taken nothing from the time I received my second dose Thu until then.  I took over the counter Chlorpheniramine (4mg) one time and that seemed to relieve the symptoms.  The next day I was 85% better (Tue), but it took exactly 7 days (Thu) before I was back to normal. For the 3 - 5 day period following my second dose, it was a little bit scary struggling to breathe and thinking I was having a heart attack.  I almost went to the hospital, but I didn't because I take care of my elderly father and could not leave him by himself.  If this had happened to me out of the blue, I would have gone to the emergency, but I had read of people having reactions to the vaccine after the second dose so I was mentally prepared to ride it out.  I didn't read about people having my particular side effect, so I thought I was an outlier of sorts. I am filling this out now because there are reports coming out that the Pfizer vaccine may be tied to myocarditis in men, and from the symptoms explained, it seems to line up with what I experienced.  Although I had Moderna, not Pfizer, I thought maybe I should report it in case it is a generic "mrna vaccine" issue.
pt says about 2 days later after the vax her heart was pounding so hard that she could not catch her breath.  She laid down for a while.  Pt went to her PCP to get a EKG.  EKG was normal.  She noticed at her doctors appt she had developed a red rash on her back, torso, arms, legs, and palms of her hands.  She was given RX for cetirizine.  This medicine worked and symptoms were better within the next day.  Pt was told all of her symptoms were due to having the covid vax.
I had the expected flu-like symptoms for about 36 hours after the injection. After that I had allergy problems.  Over 20 years ago, I had a peanut allergy. I never needed to go to a hospital, it just caused terrible headaches.  I overcame it by eating a half peanut a day for a week, then a peanut a day, and so on.  A few times a month now, I eat a handful of peanuts or so, just to make sure I can continue to eat them.  I made a stir-fry dinner that used peanut butter as a thickener a few days after the shot, and I couldn't eat it.  It made my mouth itch, which is another one of my allergy symptoms.  I had just a few bites, but I felt off for the rest of the evening.  The next day I tried to smell a jar of peanuts, and the smell made me queasy.  After about two weeks, I was fine, and I can eat peanuts again with no problems.  However, my seasonal allergies are much worse this year, and I've been having random dizzy spells, usually after eating, but also if I stand up too quickly or if I have a sudden exertion like going from sitting to running up the steps.   I can attribute my problem with peanuts to the vaccine, but I'm not sure if the rest is relevant.  I thought it was better to tell someone than not.
Pt had a local reaction to vaccine (hives down the arm, itching and redness).
pt devel difficulty breathing; given adrenalin & Solumedrol; pt hospitalized over noc for observation; also anaphylaxsis;
BLOOD CLOTS; This spontaneous report received from a consumer (source: news report) concerned a female of age under 60. 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 not reported, batch number: unknown, expiry: unknown) dose, start therapy date were not reported, 1 total administered for prophylactic vaccination. The batch number was not reported. Per procedure, no follow-up will be requested for this case No concomitant medications were reported. It was reported from a news story that, on an unspecified date, the patient experienced blood clots which was in investigation by an agency.  The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of blood clots was not reported. This report was serious (Other Medically Important Condition). This case, from the same reporter is linked to 20210454646.; Sender's Comments: V0:20210454446-covid-19 vaccine ad26.cov2.s- Blood clots. This event(s) is considered unassessable. The event(s) has a compatible/suggestive temporal relationship, is unlabeled, and has unknown scientific plausibility. There is no information on any other factors potentially associated with the event(s).
On the 8th day I developed a pink rash (about the area of a softball) directly below the injection site. Slightly raised welt the first couple of days. Used Cortisone 10 for the itching for 3 days. By 5th day it was all cleared up. Otherwise I had a sore arm about 36 hours (took Tylenol for that) and was tired the first night. No other issues.
Adult patient received doses after its expiration date 13-Jul-2022; No adverse event; This spontaneous case was reported by a pharmacist and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Adult patient received doses after its expiration date 13-Jul-2022) and NO ADVERSE EVENT (No adverse event) in an adult patient of an unknown gender who received mRNA-1273 (Spikevax) (batch no. 004m21a) for COVID-19 prophylaxis.     No Medical History information was reported.    On an unknown date, the patient received dose of mRNA-1273 (Spikevax) (unknown route) 1 dosage form. On an unknown date, the patient experienced EXPIRED PRODUCT ADMINISTERED (Adult patient received doses after its expiration date 13-Jul-2022) and NO ADVERSE EVENT (No adverse event). At the time of the report, EXPIRED PRODUCT ADMINISTERED (Adult patient received doses after its expiration date 13-Jul-2022) and NO ADVERSE EVENT (No adverse event) outcome was unknown.        For mRNA-1273 (Spikevax) (Unknown), the reporter considered NO ADVERSE EVENT (No adverse event) to be not related. No further causality assessment was provided for EXPIRED PRODUCT ADMINISTERED (Adult patient received doses after its expiration date 13-Jul-2022).    No concomitant medications were reported.  It was reported that, the patient received vaccine from expired vial. Further it was stated that, there were no remaining vials unused of expired lot number.  The vial did not undergo any temperature excursions.  No treatment medications were reported.  This case contains information for the 52nd of 56 patients described by the reporter.   This case was linked to US-MODERNATX, INC.-MOD-2023-701125 (E2B Linked Report).; Sender's Comments:  US-MODERNATX, INC.-MOD-2023-701125:Master case
Moderna COVID-19 vaccine EUA Headache, nausea, heart palpations, rapid heart beat, elevated blood pressure Trip to ER Heart was not impaired
Became lightheaded, felt ill, then had near syncopal event starting about 2 minutes after the vaccination. Did not pass out, then felt better with lying down and drinking water 5 minutes later.
Hives above waistline.  Light amount, approximately 20 spots.  Completely cleared up by 11/19/2003.
SEVERE ARM PAIN IN RIGHT ARM IMMIETELY AFTER RECEIVING VACCICE, NOW GETTING WORSE, WEAKNESS, LOSS OF FEELING, SHOULDER PAIN, ELBOW PAIN HAND PAIN-CANNOT MOVE ALL MY FINGERS, SORENESS, SLEEPLESSNES DUE TO PAIN ,NUMNESS, CANNOT LIFT,CANNOT SWIM , CANNOT USE THAT ARM AT ALL
Patient developed abdominal pain about 1 month following vaccine. She was diagnosed with appendicitis and her appendix was removed. The pathology of her appendix demonstrated a neuroendocrine tumor of the appendix.
Patient vacant 15 minutes after the shot.  After 15 minutes when she get up + walk she fell little bit dizzy + palpitation few minutes.  Notified provider + provider said it's OK.
The event shortness of breath, rapid heart beat/pounding, dizziness, and palpitations. Currently wearing a heart etc monitor for 7 days. F/U appointment July 27, 2021
pt began screaming @ 2PM & was unconsolable for over 3 hrs; also vomited @ 6PM;
As soon as the injection occurred, I had intense pain not just at the injection site but throughout my left arm. I also felt that my pulse was very fast. This continued through the next week. The next day, I had a migraine in the evening and could not sleep. Earlier in the day, I started to have incredible dizziness and weakness. On the 3rd day in the afternoon, I became so nauseous when standing outside, that I wasn't able to go back into the house on my own. I was dizzy and weak. These symptoms kept coming in waves. I also still felt the adrenaline-type rush. I was so weak that I had to rest. These symptoms continued for a total of a week and a half.
Gave 0.25 cc Fluvirin instead of Fluzone in left thigh IM.
Case previously recorded as MA2009-4327. Initial case report received from a physician via agency, on 16 NOV 2009. An 18-year-old female pregnant patient was vaccinated with 0.5 mL of FLUVIRIN (batch no. unknown) i.m. on 16 NOV 2009. Upon injection, some of the vaccine leaked from the area of needle attachment onto the patient's arm. As a consequence, patient did not receive full dose. No adverse effect was reported. Agency reference no.: NA09-008243. Follow up report received on 26 Apr 2010: There was an attempt to contact reporter, but no response received so far. Therefore the case was closed with a consideration as a lost to follow up.
Patient was given Td in Left arm and Tdap in Right arm mistakenly. (was suppose to receive Tdap and HBV#2).
One day post vax pt experienced weakness, rapid heart beat, facial flushing, and diarrhea.
Dizziness; weakness; headache began within on hour of vaccination; nausea began the next day; This is a spontaneous report from a contactable consumer or other non hcp.   A 36-years-old female patient received bnt162b2 (BNT162B2 PFIZER-BIONTECH COVID-19 MRNA VACCINE; Solution for injection (Batch/Lot number was not reported), dose 1 via an unspecified route of administration, administered in Arm Left on 31May2021 18:15 (Batch/Lot number was not reported) as dose 1, single for covid-19 immunisation. Medical history included migraines, drug hypersensitivity, food allergy, food allergy, rubber sensitivity, allergy to arthropod sting. The patient's concomitant medications were not reported. The patient did not receive any other vaccine in four weeks. Prior to vaccination patient diagnosed with COVID. Post vaccination patient did not test for COVID.It was reported that, the patient experienced dizziness, weakness, headache and nausea began within one hour of vaccination on 31May2021 19:00 with outcome of not recovered.  Follow-up attempts are needed; Information about lot/batch number has been requested.  Follow-up (05Jul2021): This follow-up is being submitted to notify that the lot/batch number is not available despite the follow-up attempts made. Follow-up attempts completed. No further information is expected.
On 12/12/2021- extreme pain in my right big toe and redness that kept getting progressively worse. I went to see my podiatrist, and he did a Uric acid test that came back positive for gout. I have never had gout before. They gave me  a medication, colchicine.  I took 5 dosages it gave me stomach issues. I started taking Tart cherry extra to help prevent the flare up.
Severe headache, nausea, all-over muscle pain, joint stiffness, fatigue, temp went up but not enough for a fever. I took Bayer for the muscle pain and slept. Developed soreness of injection  site approximately an hour after injection. Muscle stiffness and joint pain began that night. Other symptomst started Thursday morning and ended Friday morning.
Psoriatic arthritis flare up; This is a solicited report received from contactable reporter(s) (Consumer or other non HCP). Other Case identifier(s): 22K-163-4532174-00.  A 58-year-old male patient received BNT162b2 (BNT162B2), as dose number unknown (booster), single (Batch/Lot number: unknown), as dose 2, single (Batch/Lot number: unknown) and as dose 1, single (Batch/Lot number: unknown), all intramuscular for covid-19 immunisation; adalimumab (HUMIRA), (Batch/Lot number: unknown), subcutaneous for psoriatic arthropathy. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: PSORIATIC ARTHROPATHY (medically significant), outcome "recovered", described as "Psoriatic arthritis flare up". The action taken for adalimumab was unknown.  The reporter's assessment of the causal relationship of "psoriatic arthritis flare up" with the suspect product(s) BNT162b2 was not provided at the time of this report. Since no determination has been received, the case is managed based on the company causality assessment.  Additional information: On an unknown date, the patient experienced Psoriatic arthritis flare up. On an unknown date, Psoriatic arthritis flare up resolved. Pfizer Biontech Covid-19 vaccine (Tozinameran) was also considered suspect.   No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.; Sender's Comments: Based on available information and temporal association  the causal role of suspect BNT162B2 cannot be excluded for reported events. Case will be reviewed on receipt of FU information.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 regulatory authorities, Ethics Committees, and Investigators, as appropriate
First vaccine: site pain and swelling, headache, muscle aches, fatigue Second vaccine: site pain and swelling, headache, muscle aches, fatigue, chills fever of 100.5
Information has been received from a physician concerning a 12 month old female patient with no pertinent medical history or drug reactions/allergies. On 24-FEB-2015, the patient was vaccinated with a dose of VARIVAX (Merck) (lot#, expiration date, dose and route not reported). The physician reported that the patient then ingested an unspecified toxin which caused a tracheoesophageal fistula to develop and the patient was hospitalized, at an unspecified facility, on 02-MAR-2015. The physician stated that this occurrence was "completely unrelated" to the VARIVAX (Merck) administration. The physician reported that part of the patient's treatment was administration of the "steroids", dexamethasone (manufacturer unknown) and methylprednisolone (manufacturer unknown) (unspecified dose and form). Following the administration of these steroids the patient developed a varicella like rash on 16-MAR-2015. The patient was being treated with acyclovir for treatment of the rash. The patient was recovering from the rash, but remained in "critical condition" due to the fistula. Additional information has been requested.
Coughing; Lack of drug effect; COVID-19; Sinusitis; This spontaneous case was reported by a consumer and describes the occurrence of SINUSITIS (Sinusitis), COUGH (Coughing), DRUG INEFFECTIVE (Lack of drug effect) and COVID-19 (COVID-19) in a 54-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 047A21A and 047A21A) for COVID-19 vaccination.     No Medical History information was reported.   On 18-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 15-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. In September 2021, the patient experienced SINUSITIS (Sinusitis), DRUG INEFFECTIVE (Lack of drug effect) and COVID-19 (COVID-19). On an unknown date, the patient experienced COUGH (Coughing). The patient was treated with AMOXICILLIN for Sinusitis, at an unspecified dose and frequency. At the time of the report, SINUSITIS (Sinusitis), COUGH (Coughing), DRUG INEFFECTIVE (Lack of drug effect) and COVID-19 (COVID-19) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): In September 2021, SARS-CoV-2 test: positive (Positive) Positive.         No concomitant medication was reported by the reporter. Patient had coughing before the booster dose but this was due to sinusitis. Patient has received Amoxicillin for his sinusitis which coincides with the diagnosis of COVID-19.  Company comment This is a spontaneous case concerning a 54-year-old male patient with no relevant medical history reported, who experienced the non-serious unexpected, AESI event of COVID-19 and other non-serious events. Drug ineffective was considered an additional event. The events occurred on an unknown date, approximately 5 months after the second dose of mRNA-1273. The rechallenge is not applicable. The benefit-risk relationship of mRNA-1273 vaccine is not affected by this report.   This case was linked to MOD-2021-435715 (Patient Link).; Sender's Comments: This is a spontaneous case concerning a 54-year-old male patient with no relevant medical history reported, who experienced the non-serious unexpected, AESI event of COVID-19 and other non-serious events. Drug ineffective was considered an additional event. The events occurred on an unknown date, approximately 5 months after the second dose of mRNA-1273. The rechallenge is not applicable. The benefit-risk relationship of mRNA-1273 vaccine is not affected by this report.
Pt. developed a reaction to #1 dose of covid-19 vaccine.  Symptoms described as light headache, no hospital care provided.  Pt. verbalizes feeling better and recovered.  No V/S taken, no allergies to any medications or foods noted.
The pt came into the pharmacy on 7/1/2023 and stated that he had normal side effects from the vaccine, like fatigue and muscle soreness, but then the next day on the 6/30/2023 he started to notice numbness on the left side of his back. He had gone into urgent care and they prescribed valacyclovir, the clinic didn't really know what to do, but told him to try the antiviral anyway. The clinic told him to come back to the pharmacy and tell us about it. I told him that I was look into the issue and report the incident into this database. He stated that was fine and I also instructed him to get to his primary to discuss the incident. I let him know that if the numbness spreads or any new changes pop up he should go to the emergency room, if his primary was unavailable.
Rash on her entire torso; This case was reported by a other health professional via call center representative and described the occurrence of rash in a 69-year-old female patient who received Herpes zoster (Shingrix) (batch number unknown, expiry date 26th August 2020) for prophylaxis.   On 26th August 2019, the patient received the 1st dose of Shingrix .5 ml. In August 2019, less than a week after receiving Shingrix, the patient experienced rash. On an unknown date, the outcome of the rash was unknown.   It was unknown if the reporter considered the rash to be related to Shingrix.  Additional details were reported as follows: Patient experienced rash on her entire torso. No further details were provided.  The case has been linked with case US2019158353, reported by same reporter.
Severe  Shingles that started 2 days after Adminstration of the vaccine including severe chest/breast pain and vesicular rash 4 days after the vaccine.  Shingles required antiviral treatment.  I have severe pain since then.
This report was received from manufacturer research for Haemophilus B conjugated vaccine (+) hep B vaccine and was assigned manufacturer control number HQWYE036305MAY03. A female pt was vaccinated with a dose of Haemophilus B conjugate vaccine (+) hep B vaccine recombinant. The reporter indicated that the pt developed a generalized, erythematous, macular-papular rash. The outcome of the event was reported as unknown. This was originally reported by a physician. Additional info was received from the physician which indicated that on 2/13/03 an 18 week old female with no allergies or medical history was vaccinated IM in the left thigh with a second dose of Haemophilus B conjugate vaccine (+) hep B vaccine recombinant (643037/0652M). Concomitant vaccinations on the same day an time included a second dose in the left thigh of Prevnar (491183), a dose in the right thigh of Tripedia (U08508A) and a dose in the right thigh of IPOL (W006B). It was noted that the pt had no problems with an intiial dose of Haemophilus B conjugate vaccine (+) hep B vaccine recombinant on 12/18/02. There was no illness at the time of vaccination. The pt's mother reported that on 3/14/03 a rash began on the left leg around the injection site Comvax or Prenvar. The reporter indicated that the rash started in the left thigh where the Prevnar dose was administered. The rash subsequently spread to the entire body but there were no respiratory symptoms. It was reported that the pt recovered. It was also noted that the pt and the pt's sibling had no adverse events following prior vaccination. On 4/14/03 the pt was vaccinated in the right thigh with a dose of Tripedia (U08508A) and a dose in the left thigh of IPOL (W0703). On 4/22/03 the pt was vaccinated with a third dose in the left thigh of Prevnar (492893). At the time of vaccination, the pt had bronchitis which was noted to be improving. Concomitant medications included Pulmicort, Xopenex, and Benadryl. On 4/26/03, at six months of age, the pt developed an injection site reaction characterized by a "knot" and a rash following the receipt of her third dose of Prevnar. It was reported that the pt recovered. The physician noted that because of the similar symptoms that developed after the third dose of Prevnar was given at six months of age, "this is the likely culpiro (not "Haemophilus B conjugate vaccine (+) hep B vaccine recombinant). The physician also noted, "we believe this reaction was due to another vaccine" (Prevnar). No further info is expected. Info was received on 6/17/03 which pertained to events that occurred four months after vaccination with Haemophilus B conjugate vaccine (+) hep B vaccine recombinant. This info contained the following adverse experiences: injection site reaction characterized by a "knot" and a rash 4/26/03. Bronchitis (approximately 4/22/03.
Only had flu 3 times; Initial information received on 28-Nov-2020 regarding an unsolicited valid non-serious case from a patient.  This case involves a patient of unknown demographics who only had flu 3 times (influenza), while the patient received vaccine influenza vaccine.  The patient's medical history, past medical treatment(s), vaccination(s) and family history were not provided.   Concomitant medication was not reported.  On an unknown date, the patient received a dose of suspect influenza vaccine produced by unknown manufacturer (lot number and expiration date not reported) via unknown route in unknown administration site for prophylaxis vaccination.   On an unknown date, (latency unknown) after the administration of suspect vaccine therapy, the patient only had flu 3 times (influenza).   No laboratory data was provided.   It was not reported if the patient received a corrective treatment.  At the time of report, the outcome was unknown for the event.     There will be no information available on the batch number for this case.