chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Initial information regarding an unsolicited valid non-serious case received on 05-Oct-2018 from a consumer. This case involves a 69 years old male patient who experienced caused a hematoma, egg sized area on arm that is 5 cm wide and 4 cm  tall, swelling at injection site, soreness, while he received vaccine FLUZONE HIGH DOSE. The patients past medical history, medical treatment(s), vaccination(s) and family history were not provided. On an unknown date, the patient received a dose of suspect INFLUENZA USP TRIVAL A-B HIGH DOSE SUBVIRION VACCINE lot number not reported via unknown route in the right arm. On an unknown date, the patient developed a non-serious welling at injection site, soreness, caused an egg sized area on  arm that is 5cm wide and 4cm tall and noted vaccine leaking down his arm at time of injection, following the administration of INFLUENZA USP TRIVAL A-B HIGH DOSE SUBVIRION VACCINE. It was reported that pharmacist held the syringe and pinched my shoulder, gave injection to right arm and than I felt liquid down my arm. It was also reported that might have hit a vein and caused a hematoma. There was medicine still in the syringe.  It was an actual medication error due to wrong injection technique (hit a vein), underdose (there was medicine still in the syringe) and exposure via skin contact (vaccine leaking down his arm at the time of injection). This is also a case of syringe leak. Other relevant tests included no lab data. Final diagnosis was caused a hematoma, egg sized area on arm that is 5 cm wide and 4 cm  tall, swelling at injection site, soreness. It was not reported if the patient received a corrective treatment. The patient outcome was not reported for the events. This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holders compliance with the requirements set out in Directive and Module VI of the Good Pharmacovigilance Practices. The classification as a medical error is in no way intended, nor should it be interpreted or construed as an allegation or claim made by the marketing authorization holder that any third party has contributed to or is to be held liable for the occurrence of this medication error. List of documents held by sender: none.
Feeling of light headedness; This spontaneous case was reported by a consumer and describes the occurrence of DIZZINESS (Feeling of light headedness) in an elderly female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.    Co-suspect product included non-company product RISANKIZUMAB (SKYRIZI [RISANKIZUMAB]) for Plaque psoriasis.    No Medical History information was reported.   On an unknown date, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form On an unknown date, received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form and dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. and RISANKIZUMAB (SKYRIZI [RISANKIZUMAB]) (Subcutaneous) at an unspecified dose. On an unknown date, the patient experienced DIZZINESS (Feeling of light headedness). At the time of the report, DIZZINESS (Feeling of light headedness) had not resolved.      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.   No concomitant medications were reported.  The reporter causality for the event of light headedness was not provided.  It was unknown if patient was enrolled in the COVID-19 vaccine clinical trial.  No treatment medications were reported  This case was identified as part of a retrospective clean-up activity where certain emails received in the Moderna mailbox were missed to be booked in.
Within 12 -15 hours I was feeling the same tingling hot feeling in my brain, top of my head, side of my face  that I felt when I had the stroke in April. I am starting to think that this vaccine led to my stroke.
Chill & hard to breath -> pt doesn't have BENADRYL at home (so, asked him to use his breathing medications for COPD & call 911).
Received Flu and Pneumonia vaccines 1/16/14. On 1/17 pt c/o (R) upper arm pain, tender deltoid area. On 1/18 pt continue to c/o pain, tenderness, redness, warm to touch. MD aware. KEFLEX ordered. 1/19 continue to c/o pain, using cold compress, keeping elevated. TORADOL 30 mg IM x1 for pain. Diagnosis cellulitis.
FIRST DAY: VOMOTING (3X) SECOND DAY: LETHARGY/BODY ACHES
Fever; fFtigue; Headache; This spontaneous case was reported by a consumer and describes the occurrence of PYREXIA (Fever), FATIGUE (fFtigue) and HEADACHE (Headache) in a 46-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 025L20A) for COVID-19 vaccination.     No Medical History information was reported.    On 05-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 05-Feb-2021, the patient experienced PYREXIA (Fever), FATIGUE (fFtigue) and HEADACHE (Headache). At the time of the report, PYREXIA (Fever), FATIGUE (fFtigue) and HEADACHE (Headache) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.      Reporter did not allow further contact; Sender's Comments:
Already had taken the Pfizer primary series.  Should not have been allowed to take any NovaVax.
Information regarding PREVNAR was received from a healthcare professional regarding a patient who experienced more pain after receiving PREVNAR than reported with receipt of MMR vaccine. The patient received a dose on an unspecified date. The patient experienced more pain after receiving PREVNAR than reported with receipt of MMR vaccine. Patient's receiving PREVNAR report a pain threshold of 9 or 10 out of 10 compared to 5 out of 10 for MMR vaccine. No outcome was reported. The reporter was unable to specify the number of patient's who experienced this event. Additional reports will be generated when identifying information is provided. No additional information was available at the time of this report. See related case(s): US WYE H15566910 (adverse event, non expedited).
Vaccine was given to 16 year old patient, briefly complained of dizziness, but resolved after observation.
I had fatigue, sore throat, mild congestion, low-grade, and fever. I tested positive for COVID-19. I spoke to my doctor and they prescribed Paxlovid. I tested negative in 5 days.  When I got back from work I felt bad again and tested positive again for COVID-19. I had the same symptoms but milder.
FIVE MINUTES AFTER RECEIVING THE VACCINE THE PATIENT BEGAN HAVING NAUSEA, LOOKED PALE AND WEAK. WAS TAKEN IN A WHEELCHAIR TO ER.
Swelling and redness at injection site. Treated with antibiotics but really I doubt infection. Child also had low grade fever and chills. Problem rapidly resolved w/o sequela.
Information has been received from a physician concerning a female in her "thirties" who at least ten years ago was vaccinated with a dose of MMR II (dose, route and lot number not reported). One or two weeks after vaccination, the patient experienced symptoms of transient arthritis. The patient recovered within an unspecified time. The patient sought unspecified medical attention. This is one of several reports from the same source. No further information is available.
had covid Oct'20 - lost taste and smell, tight chest, cough, asthma, tired, stomach issues 1st shot no issues except arm soreness 2nd shot - few days later got tightness in chest like asthma - went to DR to be checked and got medicine for 10 days.  didn't work, so called back and they sent me to urgent care - they gave me a nebulizer... did that for several weeks.  didn't work.  Coughing is worse, tightness is still there and chest burning is now happening.  Cough is incontrollable if i start talking ? I loose all my air.  not as bad if just walking around / physical.  I am very tired all the time.  smell burnt stuff a lot.  have had tests done, all come back normal.  this is effecting my daily life and I'd like to figure out what is going on, why, and how long, is it permanent, what kind of damage is there, is it treatable, etc...  I am really upset and frustrated. It has been 6wks.
erythema, edema to rt inner arm (upper), down to elbow;tx DPH;ice to arm;
Systemic: Exhaustion / Lethargy-Severe, Systemic: Fainting / Unresponsive-Severe, Systemic: Nausea-Medium, Systemic: Seizure-Severe
booster doses administered after expiration date; This spontaneous case was reported by a physician and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (booster doses administered after expiration date) in a  patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 046C21A) for COVID-19 vaccination.     No Medical History information was reported.    On 15-Nov-2021, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 15-Nov-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (booster doses administered after expiration date). On 15-Nov-2021, EXPIRED PRODUCT ADMINISTERED (booster doses administered after expiration date) had resolved. Not Provided      For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   The vial did not undergo any temperature excursions. The vial was initially stored in the refrigerator less than 72 hours before vials were used (administration date).  No concomitant medications were reported. No treatment information was reported.
pt recv vax 15MAY97 approx 10AM realized had hives 9PM p/shower;the hives were worst on legs, some on arms, few on neck & back, several on stomach;hives itched until last noc when med given;
Rapid heart rate, increased awareness of heart beat. At times, my heart felt like it was beating very strongly, even when I was sitting or at rest, to the point that I was hyper aware of how strong it felt.
Client received 1st dose Pfizer COVID-19 vaccine on 1/4/21 (LOT#EL1284) .  Stated he "caught COVID" and was unable to received the 2nd dose in the series .  Client presented today for 2nd dose Pfizer COVID-19 vaccine to finish the series as per CDC/Manufacture guidance; 144 days after the 1st dose received.    vaccine provided, no adverse reactions noted or reported.
Within a minute of receiving the vaccine, pt reported itchy/tingly sensation in her mouth and throat. Initially stated she could breathe/swallow just fine but very quickly stated the swallowing was getting more difficult. 911 was called  followed by 0.3 mg EpiPen in her right outer thigh and 50mg of oral Benadryl. Her BP was then taken around 4:45 and it was 162/93 at which point EMT arrived and took over.
Due date June 3rd currently 26 weeks 6 days. History of low progesterone in pregnancy and a SCH in the first and second trimester. Over the last two days a significant increase in contractions. Pain in the uterus not associated with contractions as well starting 3/3.
Site: Redness at Injection Site-Mild, Additional Details: rash at injection site
small round red areas under my skin; This spontaneous case was reported by a patient and describes the occurrence of ERYTHEMA (small round red areas under my skin) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 1773 and 11320A) for COVID-19 prophylaxis.     No Medical History information was reported.   On 04-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 28-Jan-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 22-Aug-2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient experienced ERYTHEMA (small round red areas under my skin). At the time of the report, ERYTHEMA (small round red areas under my skin) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant medication were provided  It was reported that patient had the Covid shot the only medication that has changed with regular medication. Patient started on Prolia, however, that was after patient noticed the skin issue. Patient had been to dermatologist and Internal medicine doctor that do not know what was causing this under the skin. The Internal Medicine doctor has ordered a complete autoimmune blood work up ,however , the results will take 5 weeks to be completed.  The patient has iced the area and tried homeopathic therapies. Patient also used Arnica, some lotion, Vaseline, and tea tree oil.   This case was linked to MOD-2022-644598, MOD-2022-644265 (Patient Link).   Most recent FOLLOW-UP information incorporated above includes: On 12-Sep-2022: Follow up received contains significant information, reporters, suspect product information and dosing regimens were updated
Vomiting, nausea, headache. Nausea started on 4/13 around 3 am and I've had it on and off the last few days. Headache and really bad neck pain started 4/14, along with the nausea. Felt nauseated all day 4/15 and started vomiting around 6:00 pm.
Chills at night.  Felt weird probably fever.  are very sore.  Started late evening 27th / early am 28th.
expired vaccine given to patient; This spontaneous case was reported by a pharmacist and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (expired vaccine given to patient) in a 24-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 041J21A) for COVID-19 vaccination.     No Medical History information was reported.  On 29-Dec-2021, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 29-Dec-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (expired vaccine given to patient). On 29-Dec-2021, EXPIRED PRODUCT ADMINISTERED (expired vaccine given to patient) had resolved.      For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant medication was reported.  Pharmacist stated that, on 29-Dec-2021 at 10.30 am to 02.55 pm, patient received an expired dose of the Moderna COVID-19 vaccine. The vial was punctured on 28-Dec-2021 at 10 pm, and used for up to 17 hours post puncture. The vial did not undergo any temperature excursions.  No treatment information was provided.
Within 15-minutes, the patient reported feeling lightheaded. EMS managed patient's condition on-site
Expired Engerix B administered/Expired Drug Used; This case was reported by a nurse via call center representative and described the occurrence of expired vaccine used in a 22-year-old male patient who received HBV (Engerix B adult) (batch number K2L79, expiry date 12th August 2022) for prophylaxis.   On 1st September 2022, the patient received the 2nd dose of Engerix B adult. On 1st September 2022, unknown after receiving Engerix B adult, the patient experienced expired vaccine used. On an unknown date, the outcome of the expired vaccine used was unknown.   Additional Information: GSK Receipt Date: 30-SEP-2022 Reporter's comment: The licensed practical nurse reported that a dose of Engerix B adult given to the patient and it was already expired. The reporter consented to follow up. Additional Supportive Information: The use of Engerix B adult dose, which was already expired on 12th August 2022, which led to expired vaccine used.
pt c/o being unable to see;bright light;dizziness,nausea;1st had pt sit w/head between knees;noted pt was very pale&skin was clammy;VA taken&called provider;BP 64/50,P64,R22;pt sent to hosp;when pt left w/EMS vs 110/70,P68,R22;n/v
Until 12/26/20 no symptoms whatsoever, and I started feeling congested on the 26th early evening around 6-7PM. The next evening I was actually talking to my sister and I coughed and she brought to my attention about my cough. It was late around 7PM. The next morning, around 4AM I woke up with a terrible ear ache. I called my doctor on the 28th and he suggested a COVID test at his office.  On Thursday 12/31/20 in the morning he called me giving me positive results for COVID.
This spontaneous report as received from a nurse practitioner refers to a 12 month old patient of unknown gender. No information on patient's medical history or concurrent conditions was provided. On 15-JAN-2015, the patient was vaccinated with a dose of PEDVAX HIB lot # K008874 (dose, strength, route of administration and expiration date were not reported) which had temperature excursion (incorrect product storage). No information on patient's concomitant medication was provided. This is one of several reports from the same reporter. Additional information has been requested.
suspected SIRVA-sore and painful arm appeared 1-2 days after injection.  Unable to lift her arm over her head and having trouble sleeping from the pain. Patient had been taking Advil.  Advised her to also ice the arm and the next day she reported it already feeling better.
NP. called and stated patient had welt on left arm approx. 5 in across and 7 in up and down left arm where shot was received, that was hot to the touch and fire red. The NP. stated that her harm was still looking like this on 4/25/19 when she called to make the health department aware.
Started to have constant tinnitus/ringing in ears 10-15days after the first dose. Did not stop from then.
My son's area where the shot was given got red, swollen, and hot to the touch. He also developed a fever about 7 hours after he received the shot. His fever has lasted since Friday. This is the 5th day with the fever. He also complains of tummy aches, head hurting, and stomach pain.
had a fever redness and now has a bump the size of a dime on her right arm.
After the vaccine felt extreme pain around the injection site went away after couple days. I still have some itching feels not so bad. I have exp fatigue and more frequency in headaches than normal in my migraines. A day and half later I had to use my inhaler for the wheezing it eventually went away. I have missed couple days of work due to the frequency in headaches.
Patient experienced severe chills, fever, severe headache, diarrhea, and severe body aches 10 hours after administration of first dose of Moderna COVID vaccine.  No medical treatment was sought.
buzzing in ears; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 74 year-old female patient received bnt162b2 (BNT162B2) (Lot number: EN6203) at the age of 74 years as dose 1, single and (Batch/Lot number: unknown) as dose 2, single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: TINNITUS (non-serious), outcome "not recovered", described as "buzzing in ears". Additional information: Clinical course: Event started about a week after first vaccination and continues until second dose.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.; Sender's Comments: Linked Report(s) : US-PFIZER INC-2021386101 Same reporter, suspect drug, event; different patient.
Patient went to facility on 9/12/14 morning for a PE and received a flu shot. 3 hours later, he returned with complaints of tongue swelling and abnormal breathing sensations. He was instructed to go the ER. Since arrival to the ED, patient was feeling fine but complaint of a runny nose and sore throat.
3 hours after injection, developed profuse sweating on neck in air conditioned room followed by hives on neck and chest, itching, pain. was advised to take benadryl. fell asleep within one hour. Hives reoccured every day for one week. I still have redness and bumps.  12 hours after injection, developed very sore arm, pain with range of motion, headache which resolved with Motrin, fatigue-slept 18 hours. 3 days after injection developed diarrhea which is still occuring 3 weeks after. developed severe PMS 2 weeks earlier than usual which has never happened. Breasts not just tender-they hurt. terrible cramps, which i never get. bleeding through super ultra tampon every 45 minutes which has never happened. Unable to exercise because of dizziness and fatigue. I typically exercise 5 days per week including jogging, hiking, resistance training. today, June 3,  I became very confused and felt like my brain wasnt sending signals to my body. I cannot remember what I needed to do 5 minutes ago. I went to fill up my sink to do dishes and poured water on the counter instead of drain, I poured coffee in my eye.
Tested positive for COVID; Sore throat; Cough; Loss of taste; Loss of taste and smell; A spontaneous report was received from a Healthcare Professional concerning a 62-years-old, female patient who received Moderna's COVID-19 vaccine (mRNA-1273) and experienced events tested positive for covid, sore throat, cough, loss of taste and smell.  The patient's medical history was not provided. No relevant concomitant medications were reported.  On 25 Jan 2021, prior to the onset of the events the patient received their first of two planned doses of mRNA-1273 (Batch Number: 037K20A) for prophylaxis of COVID-19 infection.  On 25 Jan 2021, the patient experienced the events tested positive for covid, sore throat, cough, loss of taste and smell.  Treatment details included azithromycin medication, OTC medications and allergy medications.  Action taken with mRNA-1273 in response to the events was not reported.  The outcome of the event tested positive for covid, sore throat, cough, loss of taste and smell was not reported.; Reporter's Comments: Based on the information provided, the natural history of COVID-19 and the established information about the mRNA-1273 vaccine, a causal association between the event of tested positive for covid and the product use is assessed as unlikely.  The patient was most likely exposed to the disease prior to vaccination. sore throat, cough, loss of taste and smell. are assessed as due to COVID -19.
I got a Blood clot in the bottom of my foot and I am very concerned; This is a spontaneous report from a contactable consumer.  A patient of unspecified age and gender received BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, solution for injection) dose 2 via an unspecified route of administration on 24Apr2021 (Batch/Lot Number: EW0167; Expiration Date: Aug2021) as dose 2, single for COVID-19 immunisation.  The patient medical history and concomitant medications were not reported. The patient previously took BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, solution for injection) dose 1 on unspecified date for COVID-19 immunisation.  The patient stated, "I am calling because my Pharmacist suggested that I call and I have been in a "quarantine" (further not clarified) for 8 months. I had my Pfizer vaccine, I had my second (dose) Pfizer vaccine on 24Apr2021 and then next day (25Aug2021), I got a blood clot in the bottom of my foot and I have seen my Doctor and had series blood test and I am trying to feel what is going on. I have the history of good health and no never had a blood clot, never had any issue before taken that vaccine for my life, I never had any issues. Now I am just like, if I am not going to booster vaccine but I am very concerned about what to do next, I don't know about taking the Booster shot (Covid-19 Vaccine) that concerns me. You guys are Pharmacist suggest me, you guys maybe having some ideas or something." The outcome of the event was unknown.
Thursday evening I began feeling run down & quite tired. I awoke Friday morning with a nasty headache, body aches, chills & a fever of 101. These symptoms began to go away midafternoon, although I had the headache  & body aches all day long. Saturday I awoke feeling much more normal, just general tiredness.  I have also had site pain that began Thursday night. With my first dose that pain lasted for about a week.