chrisvoncsefalvay/vaers-outcomes huggingface dataset:
In case it was pneumonia; Not feeling good since the vaccine; severe dizziness; vertigo; This spontaneous case was reported by a consumer (subsequently medically confirmed) and describes the occurrence of PNEUMONIA (In case it was pneumonia) in a 76-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 018B21A and 046B21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     no medical history was reported by reporter.  Concomitant products included OMEPRAZOLE, METOPROLOL TARTRATE, LOVASTATIN, CLOPIDOGREL, FINASTERIDE, HYDROCHLOROTHIAZIDE (THIAZIDE), MONTELUKAST, FUROSEMIDE, FELODIPINE, BUSPIRONE, SPIRONOLACTONE, DOXAZOSIN MESYLATE, LABETALOL, ASA and IRON for an unknown indication.   On 26-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 23-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 23-Apr-2021, the patient experienced DIZZINESS (severe dizziness) and VERTIGO (vertigo). On an unknown date, the patient experienced PNEUMONIA (In case it was pneumonia) (seriousness criterion medically significant) and FEELING ABNORMAL (Not feeling good since the vaccine). At the time of the report, PNEUMONIA (In case it was pneumonia), DIZZINESS (severe dizziness), VERTIGO (vertigo) and FEELING ABNORMAL (Not feeling good since the vaccine) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 23-May-2021, X-ray: inconclusive not able to determine if he had pneumonia. On an unknown date, SARS-CoV-2 test: negative tested twice for Covid-19 with Negative results both times.         On 23-APR-2021 with in one hour of vaccination the patient began to experience severe dizziness and vertigo. The patient did not receive any treatment medications for the reported events. The patient reported that he had not been feeling very good since the vaccine, stating "I don't think this is a coincidence me getting sick after I got the vaccine". He was evaluated at the Emergency Room this past Sunday on 5/23/2021, because he still wasn't feeling very good. He states he had an X-ray done and was they were not able to determine if he had pneumonia, however they treated him with IV antibiotics in case it was pneumonia. He reports feeling "a little better" since the IV antibiotics.  Action taken with mRNA-1273 in response to the events was not applicable.  Based on the current available information and temporal association between the use of the product and the start date of the event, a causal relationship cannot be excluded.   Most recent FOLLOW-UP information incorporated above includes: On 26-May-2021: TCR: AE details. Case upgraded to serious. additional adverse events were updated and narrative information was updated.; Sender's Comments: Based on the current available information and temporal association between the use of the product and the start date of the event, a causal relationship cannot be excluded.
This a spontaneous report from a contactable consumer reporting on behalf of her daughter. A 19-year-old female patient received TRUMENBA, via an unspecified route of administration on the left arm at single dose on 10Jul2017 for immunization. The patient had no medical history. The patient concomitant medications were unknown. On 11Jul2017 the patient experienced headache, fever that reached 101.5 degrees, bad muscle and body aches, really tired, site reddish and site warm and nausea. The outcome of the events was reported as recovered for Headache, tiredness and bad muscle and body aches on 16Jul2017, for fever on 14Jul2017, for site reddish and site warm on unknown date. The patient received treatment for the events.
The needle did not enter the patients muscle entirely, about 3/4 of the 1 inch needle made it into the deltoid muscle. The safety for the needle prevented the full entry. Thus the shot may have entered subcutaneous tissue instead of muscular tissue.
After headaches and fatigue following the shot (within 24 hours) I began to notice slight shortness of breath 3-5 days following. I didn't give it much thought, but, roughly two weeks after my dose I began to experience severe intercostal pain and sharp pain in the lower lobe of my right lung upon inhalation. I thought this was musculoskeletal at first but after it didn't abate within days, I went to the hospital and was diagnosed with several distal pulmonary emboli.   Luckily I survived and am currently on blood thinners while trying to determine the cause of this, having no history of blood clots personally or in extended family.
Rash on arms, legs, hands, &* feet. Looks like little blisters. Symptomatically treated with ANTHRAX, CLARITIN, & MOTRIN Vesiculopapular lesions on Bilateral upper extremities L > R & lower extremities. Mild on torso
Submitted to Docket No. 1980N-0208; 69 FR 78281, December 29, 2004 - Bacterial Vaccines & Toxoids Efficacy Review Proposal. I am retired military, having retired on 12/1/04. I was held on active duty past my original retirement date of 3/1/04, to allow doctors to continue their tests to determine why I had become ill after my fifth anthrax vaccination. Currently, I am beginning the medical evaluation process for service-connected disability. I am being evaluated for the following conditions: residuals from anthrax vaccine, dysmetabolic syndrome, acquired hypogonadotropic hypogonadism, chronic fatigue syndrome, cognitive disorder, fibromyalgia, hyperlipidemia, allergic rhinitis, hearing loss, tinnitus, post traumatic stress disorder, colon polyps, sleep apnea, and altered taste/smell. I can tell you, for a fact, that this is not the way I hoped to complete my career. I use to be in reasonably good health. Now, some days are better than others. I've sat in a room with other military members and had to listen to somebody tell us to quit crying about our health issues and we'd get the disability money. It's not about the money. Frankly, I'd rather have my health back. So would my family.
COVID-19 TEST POSITIVE; This spontaneous report received from a patient concerned a male of unspecified age.  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 prophylactic vaccination. The batch number was not reported and has been requested. No concomitant medications were reported. On an unspecified date, the patient experienced covid-19 test positive. Laboratory data (dates unspecified) included: COVID-19 virus test Positive. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of covid-19 test positive was not reported. This report was non-serious. This report was associated with product quality complaint: 90000237981.
8 DAYS AFTER COVID 19 INJECTION I DEVELOPED A LARGE RED WARM TO THE TOUCH LUMP ON MY ARM WHERE THE INJECTION WAS GIVEN. MY ARM HURTS AND THE PAIN GOES DOWN MY ARM. I HAVE BEEN SHORT OF BREATH A BIT AND A LOT MORE WHEN I RUN OR GO UP STAIRS. I HAVE HAD "CHARLIE HORSE" LEG PAIN  X 4 IN LESS THEN A WEEK. I FEEL A BIT NAUSEA AND DIZZY. THIS IS NOT AT ALL NORMAL FOR ME
First dose administered 29Mar2021. Patient has not received second dose; This spontaneous case was reported by an other health care professional and describes the occurrence of PRODUCT DOSE OMISSION ISSUE (First dose administered 29Mar2021. Patient has not received second dose) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On 29-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 PRODUCT DOSE OMISSION ISSUE (First dose administered 29Mar2021. Patient has not received second dose). At the time of the report, PRODUCT DOSE OMISSION ISSUE (First dose administered 29Mar2021. Patient has not received second dose) had 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.   No concomitant medications were reported.  No treatment medication were provided.   Most recent FOLLOW-UP information incorporated above includes: On 04-Jun-2021: Follow up received on 04-Jun-2021, contain no new information.
Administer Expired vaccine; This spontaneous case was reported by a pharmacist and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Administer Expired vaccine) in an 84-year-old patient of an unknown gender who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 031B21A) for COVID-19 vaccination.     No Medical History information was reported.    On 29-Oct-2021, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 29-Oct-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (Administer Expired vaccine). On 29-Oct-2021, EXPIRED PRODUCT ADMINISTERED (Administer Expired vaccine) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   Concomitant medications were not reported.  The pharmacist reported about the administration of expired moderna vaccine that was given as booster shot to patient. The vaccines was stored in freezer, which was taken out one to two vials and place in fridge each day as needed.  No treatment was given on the patient.
Headache, NauseaVomiting, Starting 1/4/21 evening, experienced HA, NV, and lymphadenopathy in left axilla through 1/6/21 Narrative:  Took OTC tylenol for HA
This case was reported by a healthcare professional and described the occurrence of injection site swollen in possibly 10 or more subjects of unspecified ages and gender who were vaccinated with FLULAVAL (GlaxoSmithKline). In 2012 the subjects received unspecified dose of FLULAVAL (.5 unknown, intramuscular). At unspecified times after vaccination with FLULAVAL, the subjects experienced injection site swollen, injection site pain, injection site induration and injection site reaction. The healthcare professional reported the office had up to 10 subjects or possibly more, with complaints of injection site swelling, soreness and pain, in some cases induration size of coin and injection site reaction. At the time of reporting the outcome of the injection site swollen, injection site pain, injection site induration and injection site reaction were unspecified. The healthcare professional reported another case regarding FLULAVAL; please see case A0996318A.
Patient admitted with DVT, acute occlusive venous thrombosis in the left posterior tibial and peroneal veins.
I got the shot at 9AM and came home and I was tired, so I took a nap at around 8PM. I got chills and after the chills. I got a fever of 100.1 and I called my doctor and got tested for the COVID-19, but it came back negative. Last night 11/05/2021 I feel very tired and now my arm is sore and no more fever.
The second shot they (administered) passed the 14 days window and that supposed to get rid of it/ they didn't move it to the freezer into the time; The second shot they (administered) passed the 14 days window and that supposed to get rid of it/ they didn't move it to the freezer into the time; My wife is very "early pregnant"; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP).  A female patient (pregnant) received bnt162b2 (BNT162B2) (Batch/Lot number: unknown) as dose 2, single for covid-19 immunization. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: Bnt162b2 (Dose: 1), for COVID-19 Immunization. The following information was reported: PRODUCT TEMPERATURE EXCURSION ISSUE (non-serious), POOR QUALITY PRODUCT ADMINISTERED (non-serious), outcome "unknown" and all described as "The second shot they (administered) passed the 14 days window and that supposed to get rid of it/ they didn't move it to the freezer into the time"; EXPOSURE DURING PREGNANCY (non-serious), outcome "unknown", described as "My wife is very "early pregnant"". No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.  Additional Context: When probed for the concern, reporter stated, "I am calling for my wife (consumer), she got her second dose Pfizer vaccine at withheld near my house and the Pharmacist just called and told her that the second shot they (administered) passed the 14 days window and that supposed to get rid of it. I guess Pharmacist said it comes from a truck from Pfizer and it didn't meet within that 14 days under and then they are not supposed to give it to her. I guess it passed that 14 days window and they gave it to her. They are checking the freezer too long, they didn't move it to the freezer into the time. They did not move it to the freezer in that time, so it passed the time. My wife is very "early pregnant" (further not clarified), they didn't know what are the side effects maybe. We are hoping to talk to somebody who would know because withheld Pharmacist didn't know anything, so we don't know if any technical adverse side effects, she is kind of nervous because they had a mistake. Is that makes sense?" As reporter was not willing to proceed the call. Product details (LOT#, expiration date, NDC# and UPC#) and Pharmacy details could not be probed over the call. Limited information available over the call.  Follow-up (01Nov2021): 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.
Within 10 minutes I've receiving vaccine I became dizzy flushed from the chest to the throat and face throat felt tight for a brief moment which passed quickly dizziness came back approximately one hour later then starting 2 days after injection I had diarrhea 3 days after injection that I had chills and nausea. days 4-6 after injection I had severe headache nausea chills muscle aches
Mild rash at injection site--red, bumpy, itchy--appearing about a week after injection. Around 3 inches in diameter.
Presented w/ SOB, cough, sore thorat, diarrhea, decreased appetite; admitted for COVID-19 infection; tx w/abx, steroids, melatonin; dc home w/O2
Immunization given at 5:00 pm on 11/29/2005. the next morning woke up crying for 2 hours, which was very unusual. Temp as high as 105 and never below 101 with Tylenol given every 4 hours. This lasted almost 48 hours. Ate only two times those days rather than her normal 4 times.
Patient woke with blurred vision in one eye and terrible pain at temple. Throughout the day today patient's vision decreased and he could no longer see out of eye.
45 hours after 1st vaccination, had a burning sensation on the tongue as if I drank a very hot drink and burned my tongue. I had lost my sense of taste after that.  I took a benadryl, and then next morning my sense of taste had returned.  My sense of smell was never affected.
This spontaneous report was received from a nurse refers to a patient of unknown age and gender. No pertinent medical history was reported. On 26-JAN-2015, the patient was vaccinated with expired dose of PNEUMOVAX 23 (lot # J005071 and expiration date 19-JAN-2015) dose 0.5 ml, intramuscular. No adverse effects reported. No Product Quality Complaint (PQC) was involved. Additional information has been requested.
48 year old received Fluzone HD/ no AE; 48 year old received Fluzone HD/ no AE; Initial information received on 22-Oct-2019 regarding an unsolicited valid non-serious case received from a Other Health Professional.  Linked case Number: 2019SA295850, 2019SA295848, 2019SA295846, 2019SA295847, 2019SA295849 and 2019SA295851 (same reporter).  This case involves a 48 year old male patient who received a 0.5 ml dose of vaccine Influenza Usp Trival A-B High Dose Subvirion Vaccine [Fluzone High Dose] (lot: UJ2858A, expiry date: 02-Jun-2020), via intramuscular route in the left arm on 21-Oct-2019.  The patients past medical history, medical treatments, vaccinations and family history were not provided.  It was an actual medication error due to the inappropriate age at vaccine administration and overdose.   At the time of reporting, the patient had no adverse event.  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.
This spontaneous report as received from a registered nurse refers to a patient of unknown gender, age range reported as 11 (units not reported). On 04-NOV-2014, the patient was vaccinated with a dose of (Oka/Merck) VARIVAX lot number K005180, expiration date 10-APR-2016 (dose, dose number, route and frequency were not reported) which was improperly stored. No adverse effects were reported. The patient did not seek medical attention. No product quality complaint (PQC) involved. The reporter stated that this was the information that they could find and provide and anything further would be much too difficult and time consuming due to their record keeping and tracking system. This is one of several reports received from the same reporter. Additional information is not expected because follow up has been obtained.
8/13/14 - patient noticed small area of redness and only a slight, rare itchiness. 8/14/14 pt. noticed increased area of redness. 8/14/14 12pm patient came to pharmacy - pharmacist measured a red area 3" wide 4" long - not raised.
On 5/27/2021 a parent presented to pharmacy with an Immunization Consent form signed and dated requesting a Pfizer Covid vaccine for her son.  The form listed his date of birth as 2/24/2009 which would make him 12 years old.  On Wednesday 6/2/2021 a representative from the state  immunization registry called regarding the date of birth.  She stated that the date of birth was 2/21/2010.  She informed me that the state would be looking into this and that I should contact the mother and inform her that we gave an immunization to her child who is underage.  When I spoke to the mother she stated that patient's dob was 2009.  I told her that the immunization registry listed it as 2010 and that she should look into it.  I then asked her again what the dob was and she admitted that it was 2/2010.  I told her that the state would be contacting her and hung up.  An  hour later she called to apologize to me and said she wasn't a bad mother.  She then went on to say that she put 2010 on the form and I said he could get the shot.  I corrected her and said the form has 2009 with her signature on it and that we would never give the immunization to an 11 year old.  She stated it's only 6 months no big deal.  I wished her a good vacation and hung up.
Patient presented to the pharmacy for the 2nd dose in the Shingrix  series.  The syringe malfunctioned upon administration and the dose leaked out of the syring at the point it was connected to the needle. The patient did not receive the dosage.
Case number PHEH2015US019417, is an initial spontaneous report from a pharmacist received on 30 Sep 2015. This report refers to patient of unknown demographics. Historical conditions were not reported. No concomitant medication was reported. The patient received FLUCELVAX (batch number: 173252) subcutaneously on an unknown date. No adverse event was reported.
The area started out small, then began to grow as time went on.  A week after the symptoms started, I called my doctor, but he was not giving the vaccine, I received it from a clinic so I had to go to the clinic.  They had not seen anything like it to date.  The area was very red and hot (feverish).  I had used ice and ibuprofen to help, but nothing really helped.  The clinic was able to give me a RX for an antibiotics, which helped tremendously.   I was told 2 different things.  The first was that the vaccine was given too low and it hit a vein, when I laid down, the redness went towards my back.  Then I was also told it was Cellulitis.  After the round of antibiotics,  my arm cleared up and had no further issues.
Chills, leg aches, for one full day, took Tylenol, fluids,rest, much better this morning.
A report has been received from a Physician concerning a, subject of unknown gender, who had been receiving FLUMIST QUADRIVALENT (Intranasal), 0.2 milliliters. FLUMIST QUADRIVALENT (Intranasal) started on an unknown date. The reporter stated that the patient had received expired FLUMIST. The outcome of the event of Received Expired Dose is unknown. The reporter's description of the event(s) was as follows: Unknown at this time. The report was considered to be non-serious.
Patient after a couple of hours of receiving vaccines developed fever and had episodes where she would be limp and not responsive to parent. Parent took her to ER where she was examined and discharged after she was noted to be back to normal.
Diarrhea; This is a spontaneous report from a contactable consumer (patient). A 59-year-old non-pregnant female patient received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, formulation: solution for injection, Batch/Lot Number: EN0151, expiry date: not reported), via an unspecified route of administration in the left arm on 13Apr2021 07:15 (at the age of 59-year-old) as dose 2, single for covid-19 immunisation. Medical history and known allergies were none. Prior to the vaccination, the patient was not diagnosed with COVID-19. The patient's concomitant medications were not reported. The patient did not receive any other vaccines within four weeks prior to the COVID-19 vaccine. The patient previously received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, formulation: solution for injection, Batch/Lot Number: EN6207, expiry date: not reported), via an unspecified route of administration in the left arm on 23Mar2021 07:15 (at the age of 59-years old) as dose 1, single for covid-19 immunisation and experienced diarrhoea, severe pain in lower left side, diverticulitis and black liquid stool. On 14Apr2021 05:00AM, Day 1 after shot 2 the patient experienced diarrhoea (same as before, after first dose). Switched immediately to liquid diet. No intense pain so far. Seems too coincidental to not be due to vaccine. Post vaccination, the patient had not been tested for COVID-19. The outcome of the event was not recovered.  No follow-up attempts are possible. No further information is expected.
injection site pain,tiredness, headache,muscle pain,chills,joint pain,nausea,swollen lymph nodes,arm pain
fever 103, hives on face , neck , back and chest,, dry throat , mild sob, mild lightheadedness
No adverse event; Caller reported VARIVAX administered after temperature excursion.; This spontaneous report has been received from a physician referring a patient of unknown age and gender. The patient's pertinent historical condition, concurrent condition, drug reactions/allergies or concomitant medication was not provided.   On 04-MAY-2022, the patient was vaccinated with varicella virus vaccine live (Oka/Merck) (VARIVAX) at dose 0.5 milliliter (ML), via subcutaneous (SQ), (lot number U022321, expiration date 15-JUL-2023) for prophylaxis (strength and frequency were not reported) that after temperature excursion 6 Fahrenheit (F) for 30 minutes (product storage error).There was no previous temperature excursion. No additional adverse events were reported (no adverse event).