chrisvoncsefalvay/vaers-outcomes huggingface dataset:
BLOOD CLOTS IN RIGHT FOREARM; This spontaneous case was reported by a consumer and describes the occurrence of THROMBOSIS (BLOOD CLOTS IN RIGHT FOREARM) in a 52-year-old female patient who received mRNA-1273 (COVID 19 Vaccine Moderna) for COVID-19 vaccination.    Co-suspect product included non-company product ADALIMUMAB (HUMIRA) for Rheumatoid arthritis. Concurrent medical conditions included Thrombosis leg, Venous insufficiency and Rheumatoid arthritis.   On 10-Jun-2019, the patient started ADALIMUMAB (HUMIRA) (Subcutaneous) 40MG/0.4ML. On 14-May-2021, the patient received first dose of mRNA-1273 (COVID 19 Vaccine Moderna) (Intramuscular) 1 dosage form. In May 2021, the patient experienced THROMBOSIS (BLOOD CLOTS IN RIGHT FOREARM) (seriousness criterion medically significant). At the time of the report, THROMBOSIS (BLOOD CLOTS IN RIGHT FOREARM) had not resolved. mRNA-1273 (COVID 19 Vaccine Moderna) (Intramuscular) dosing remained unchanged.   Company comment: This is a spontaneous case concerning a 52-year-old female patient with thrombosis leg, venous insufficiency and Rheumatoid arthritis on treatment with Adalimumab, who experienced the serious (medically significant) unexpected event Thrombosis in right forearm, on the same month after receiving the first dose of mRNA-1273.  Clinical course, diagnostic tests and treatment details were not provided. Adalimumab was reported as a co-suspect product. Events seriousness captured as per list. Patient´s medical conditions remains a confounder for the event. The benefit-risk relationship of mRNA-1273 is not affected by this report. No concomitant medication was reported.  Patient received Humira as Solution for injection in pre-filled pen. The reporter's causality for the event(s) of BLOOD CLOTS IN RIGHT FOREARM with Humira was no reasonable possibility. No treatment information was provided. 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.; Sender's Comments: Company comment: This is a spontaneous case concerning a 52-year-old female patient with thrombosis leg, venous insufficiency and Rheumatoid arthritis on treatment with Adalimumab, who experienced the serious (medically significant) unexpected event Thrombosis in right forearm, on the same month after receiving the first dose of mRNA-1273.  Clinical course, diagnostic tests and treatment details were not provided. Adalimumab was reported as a co-suspect product. Events seriousness captured as per list. Patient´s medical conditions remains a confounder for the event. The benefit-risk relationship of mRNA-1273 is not affected by this report.
Moderate local reaction of L/deltoid, within 24 hours, after injection. Deltoid warm, red and swollen.
8-7-21. Patient came to the ER after being diagnosed with COVID.  He had SOB and chest pain.  Received monoclonal antibodies. Returned to the ER twice after that.  2nd time was found to have PE, transferred to hospital.
Mild Atrial Fibrillation for a few days after the vaccine was administered. First noticed about 24 hours after administration.
This spontaneous report as received from a registered nurse refers to a patient of unknown age. While an unspecified healthcare professional was administering BCG VACCINE (dose, route and site of administration and lot # not reported) some of vaccine leaked out of the syringe. The healthcare professional was wearing gloves at that time. There were concerns about the healthcare professional was inhaling the vaccine that leaked out of the syringe. No adverse events were reported. It was not reported if the patient sought medical attention. The outcome of adverse events was unknown. The relatedness between adverse events was not provided. Additional information has been requested.
Redness at site of injection. By 11/2/16, redness, warmth and itching had spread to entire width of arm. Seen by Dr. and advised ice compresses and oral BENADRYL for allergic reaction.
6 weeks after receiving FLUMIST, child was unable to stand or walk because weakness in legs, could not bend chin to chest. Went to MD, MD sent him to the hospital. Hospital ruled out meningitis and said it was a viral illness. Hospital kept him for several hours and then released him. Mother told MD about FLUMIST, but not hospital but mother states he noticeably sluggish during day usually morning and evening.
1 of 2 pts vaxed from same lot# who devel erythema, induration & swelling @ inj site & fever (unmeasured);this pt had onset 12-24 hrs p/vax would not bear weight on leg for 48hrs; also had nausea & vomiting;on ceclor for URI time of vax
pt recv vax;c/o myalgia,low grade fever,sore lt arm w/ sl swelling & redness all the way to elbow;started fairly soon p/ inject;sx resolved 10jun95;
34 Y male who presents with a chief complaint of allergic reaction. Pt says that about an hour pta, he had the covid vaccine.  Felt like his throat has become "tight."  No wheezing or sob.  No chest pain.  No other complaints. Pt with allergic reaction/globus sensation following covid vaccine.  Treated with benadryl, solumedrol, pepcid and SQ epi.  After 2 hour obs, pt wanting to leave, reporting complete resolution of symptoms.  Written for epipen.  Agrees to return for any further concerning symptoms. Discussed f/u with pmd for further eval/discouraged 2nd vaccine.
RED RASH BEGAN THEN GRADUALLY SPREAD OVER ENTIRE BODY, STILL COVERED IN HOT ITCHY RED RASH 9 DAYS LATER. SAW PCP ON 3/25. USED BENEDRYL ORAL AND TOPICAL, HYDROCORTISONE PRIOR TO VISIT. PCP PRESCRIBED  ATARAX  AND EPI PEN
Information has been received from a nurse referring to a patient of unknown age and gender. The patient's concurrent conditions, concomitant medication and medical history were not provided. On 02-SEP-2016 the patient was vaccinated with improperly stored PROQUAD (subcutaneous, lot# M018636, expiration date 11-OCT-2017, strength and dose were unspecified) and VARIVAX (subcutaneous, lot# L032391, expiration date 26-AUG-2017, strength and dose were unspecified). The vaccines were exposed to 5.2 F for 10 minutes and then were back to range. There was no previous temperature excursion. Data logger issue was involved. No adverse effect was reported. Additional information has been requested.
Pt vaccinated with Pneumovax 23 developed swelling, redness, warmth & itching at the injection site w/a headache & fever. Also, c/o of nausea. Seen by MD dx w/viral synd.
24 hour post vaccination, fever, body aches, chills, muscle pain, joint pain. Knee pain severe. Knee pain requires 2 months of Physical therapy to resolve. Fever chilla and other body aches subsided after 48 houra.
Red and swollen from injection site down to elbow.  Patient used ice packs and took Tylenol and didn't get much better so went to urgent care on 3/26/16.  She was given rx for prednisone and cephalexin.
Patient is 17 years and 11 months, he will be 18 on 5-11-2021. I talked to dad, we will vaccinate on his 18 birthday. Our policy is to report  to vaers due to age under 18.  Please let me know if anything I can do. Thanks
patients have been administered doses while the temperature excursion assessment was ongoing (possible temperature excursion); patients have been administered doses while the temperature excursion assessment was ongoing (possible temperature excursion); This spontaneous case was reported by an other health care professional and describes the occurrence of PRODUCT TEMPERATURE EXCURSION ISSUE (patients have been administered doses while the temperature excursion assessment was ongoing (possible temperature excursion)) and POOR QUALITY PRODUCT ADMINISTERED (patients have been administered doses while the temperature excursion assessment was ongoing (possible temperature excursion)) in a 69-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On an unknown date, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) .25 milliliter. On an unknown date, the patient experienced PRODUCT TEMPERATURE EXCURSION ISSUE (patients have been administered doses while the temperature excursion assessment was ongoing (possible temperature excursion)) and POOR QUALITY PRODUCT ADMINISTERED (patients have been administered doses while the temperature excursion assessment was ongoing (possible temperature excursion)). At the time of the report, PRODUCT TEMPERATURE EXCURSION ISSUE (patients have been administered doses while the temperature excursion assessment was ongoing (possible temperature excursion)) and POOR QUALITY PRODUCT ADMINISTERED (patients have been administered doses while the temperature excursion assessment was ongoing (possible temperature excursion)) outcome was unknown. Not Provided      For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant medications were reported. No treatment medications were reported.  The reporter stated that their facility had not been able to download the data base, they had been put on hold by the RA at the moment. There had been no power outages that would have impacted the Moderna vaccine.  It was reported that, the facility was unable to download the digital data logger, they would need to treat this issue as a temperature excursion. The data logger was unable to download for the months of Dec-2021, Jan-2022, and Feb-2022. The reporter did not have any questions and wanted to report this to Moderna.  The reporter stated that no adverse reactions were reported by any patients.
Extremely tired, headache, joints very bad aches ( more than my usual arthritis), slight sore throat, chills
Tingly feeling in the arm where I got my Moderna Vaccine shot; keep getting chills; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE PARAESTHESIA (Tingly feeling in the arm where I got my Moderna Vaccine shot) and CHILLS (keep getting chills) in a patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.   On 09-May-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced VACCINATION SITE PARAESTHESIA (Tingly feeling in the arm where I got my Moderna Vaccine shot) and CHILLS (keep getting chills). At the time of the report, VACCINATION SITE PARAESTHESIA (Tingly feeling in the arm where I got my Moderna Vaccine shot) and CHILLS (keep getting chills) outcome was unknown.            No Concomitant and treatment  medication was mentioned.
SEVERE BODY ACHES; MUSCLE ACHES; HEADACHE; FEVER; This spontaneous report received from a patient concerned a patient of unspecified age and sex. The patient's height, and weight were not reported. The patient's past medical history included: covid-19. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, intramuscular, batch number: 207A21A expiry: 21-SEP-2021) .5 ml, start therapy date was not reported for prophylactic vaccination. No concomitant medications were reported. On an unspecified date, the patient experienced severe body aches, muscle aches, headache, and fever. Laboratory data (dates unspecified) included: Body temperature (NR: not provided) 102.3 F. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from severe body aches, muscle aches, headache, and fever. This report was non-serious.
On the day of the vaccination, I felt some dizziness and fatigue. The next day, my left arm was sore at swollen at the injection site.  On day 7 and 8, I noticed some itchiness at the injection site as well as two small red bumps.
Approx 7 hours after injection, sore arm started At  10 hours, chills started mildly and proceeded to full body shivering/spasms for 3 consecutive hours.  No pain, but unable to  stop.
Upon giving vaccine employee states she felt chills, then approximately 15 mins later she felt chills again. At 1845 she felt hot, flushed cheeks, and diaphoresis, then cold chills approx 15 min. episodes each on 9/25/2009 symptoms lasting approx 2 hrs and 15 min. Tem 103 degrees with hallucinations approx 1 degree stopped after fever brake. Emesis x4  states it was stomach and then dry because approx 10 - 15 min. She applied cold towels to head/body. Awoke next morning with dizziness and muscle pain. IBUPROFEN taken for muscle pain relief.
Patient with invasive ductal carcinoma of the left breast diagnosed in June who presented to the ED on 9/11 with a neutropenic fever. She was started on 2g Cefepime and admitted. negative. She was started on 2g Cefepime and admitted.  Since admission she has been afebrile and hemodynamically stable, and her white count and neutrophil count have slowly increased. Upon discharge, neutrophils 1.1, WBC 2.8. No true infectious etiology was found, and antibiotics were discontinued upon discharge after 2 fulls days. ED visit and hospital admission were within 6 weeks of receiving the COVID vaccine.
Syncope 5 minutes following vaccine administration, Gave the patient water and monitored for additional signs or symptoms. ambulance was called but no further treatment required. Patient recovered shortly after syncope
Narrative:  73YO MALE died inpatient . Death was caused by: Septic Shock and Acute Hypoxic Respiratory Failure secondary to acute respiratory distress syndrome and aspiration pneumonia. Patient was covid negative per 5 different covid lab testsfrom 8/7/20 through 9/8/21. Pt had received covid vaccinations on 2/17/21 & 3/10/21 at non-agency hospital. Death is not related to covid vaccinations.
Headaches; Fever; This is a spontaneous report from a contactable consumer reporting for self  A patient of unspecified age and gender received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE) Batch/Lot Number: 6202 dose 1 via an unspecified route of administration, administered in Arm Left on 01Mar2021 14:30 as 1ST DOSE, SINGLE for covid-19 immunisation  .  Medical history included blood pressure abnormal.  There were no concomitant medications. The patient experienced headaches and fever on 03Mar2021 02:00 with outcome of not recovered. No No follow-up attempts are possible. No further information is expected.
COVID 19 Treatment; COVID 19 Treatment; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 67-year-old male patient received bnt162b2 omi xbb.1.5 (COMIRNATY (2023-2024 FORMULA)), on 25Sep2023 as dose 1, single (Lot number: HG4629) at the age of 67 years, in left arm for covid-19 immunisation. The patient's relevant medical history included: "lactose intolerant" (unspecified if ongoing). The patient's concomitant medications were not reported. Vaccination history included: moderna covid-19 bivalent (DOSE 6 (BOOSTER), SINGLE, Vaccine lot number: AS7643E,, Vaccine location: Left arm), administration date: 22Jun2023, when the patient was 67-year-old, for Covid-19 immunization; Covid-19 vaccine (DOSE 5 (BOOSTER), MANUFACTURER UNKNOWN), for Covid-19 immunization; Covid-19 vaccine (DOSE 4 (BOOSTER), MANUFACTURER UNKNOWN), for Covid-19 immunization; Covid-19 vaccine (DOSE 3 (BOOSTER), MANUFACTURER UNKNOWN), for Covid-19 immunization; Covid-19 vaccine (DOSE 2, MANUFACTURER UNKNOWN), for Covid-19 immunization; Covid-19 vaccine (DOSE 1, MANUFACTURER UNKNOWN), for Covid-19 immunization. The following information was reported: VACCINATION FAILURE (medically significant), COVID-19 (medically significant) all with onset 31Oct2023, outcome "unknown" and all described as "COVID 19 Treatment". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (unspecified date) Positive, notes: Treatment of covid-19; (31Oct2023) Positive, notes: 31Oct I tested positive to Covid and started taking Paxlovid for 5 days; (10Nov2023) Positive, notes: 10Nov, I tested positive to Covid again. Therapeutic measures were taken as a result of vaccination failure, covid-19.  The information on the batch/lot number for bnt162b2 omi xbb.1.5  has been requested and will be submitted if and when received.
This spontaneous report as received from a doctor of pharmacy refers to a patient of unknown age and gender. No information about the patient's medical history, concurrent conditions and concomitant medications was reported. On 15-MAR-2016, the patient was inadvertently vaccinated with an expired dose of ZOSTAVAX injection, lot # reported as K02362, expiration date on 19-FEB-2016 (dose, route of administration and anatomical location were not specified). No adverse effects were reported. Additionally, the reporter requested information about when the patient could be revaccinated. Additional information has been requested.
This spontaneous report as received from a pharmacist refers to a 29 year old female patient. Patient had no medical history and concurrent condition. Concomitant medication was reported as none. On 18-APR-2018 the patient was vaccinated with VARIVAX (lot # N022981, 23-AUG-2019) via intramuscular route instead of the intended subcutaneous route, in the left arm for prophylaxis. The vaccine was reconstituted with a sterile diluent (MERCK). On 19-APR-2018 or 20-APR-2018, the patient started to complain of redness, swelling and pain at the injection site. The Pharmacist reports that the injection site reaction did not look like a rash. The Pharmacist reports that the patient received the VARIVAX because she had a titer drawn (on an unspecified date) at a dental school and the titer showed negative for Varicella, and it was unknown if the patient ever received VARIVAX or a Varicella vaccination in the past. Patient sought medical attention by visiting the pharmacy. An unspecified treatment was given for the events. No lab tests were performed. The outcome of varicella virus test negative, vaccination site pain, vaccination site erythema and vaccination site swelling was unknown. Causality assessment was not provided. No product quality complaint was present.
1st shot administered on 8/3/21, extreme fatigue,  nausea low fever. 2nd shot 8/29/21, almost 3 days after the shot in the middle of the night,  vomiting , violent diarrhea at the same time, fever of 101, body aches. pain, exhaustion, this lasted 24-36 hours
Baseball size area of redness-left thigh. Swelling, area hot to touch.  Treatment  Prednisone 10mg 2 tabs PO x 3D. keflex 125/5 1 tsp QID x 10 days/
Patient got his first Pfizer dose on 2/7/21 at our mass vaccination site and came for his second dose today but we were given Moderna today and patient received a Moderna vaccine by mistake. Patient was kept for observation for 30 minutes and the Medical Director for Curative Inc was consulted and he advised us to schedule an appointment for the patient in 72 hours for his second Pfizer dose so he could have his full series completed. Pt did not show any adverse effects while being monitored.
DIARRHEA; UPSET STOMACH; FATIGUE; WORST NAUSEA EVER; This spontaneous report received from a patient concerned a 26 year old male. The patient's height, and weight were not reported. The patient's pre-existing medical conditions included patient took gatorade.The patient received covid-19 vaccine  (suspension for injection, route of admin not reported, batch number: 1805029 expiry: UNKNOWN) dose was not reported, administered on 23-MAY-2021 for prophylactic vaccination. No concomitant medications were reported. On MAY-2021, the subject experienced worst nausea ever. On 25-MAY-2021, the subject experienced diarrhea. On 25-MAY-2021, the subject experienced upset stomach. On 25-MAY-2021, the subject experienced fatigue. Treatment medications included: bismuth subsalicylate, and paracetamol. The action taken with covid-19 vaccine  was not applicable. The outcome of the worst nausea ever, diarrhea, fatigue and upset stomach was not reported. This report was non-serious.
Unresponsive event, (ALT)event-possible seizure 5-6 hours after administration.
Rotarix given on 7/22 was not mixed properly and thus only diluent was given. RN tc to GSK who did not have any data to recommend when vaccine should be administered again and leave it up to discretion of provider. After discussion with staff, agreed that pt could come back asap for correct vaccine administration.
Two days post vax the pt developed a low grade fever and an injection site reaction characterized by redness and swelling. Pt was treated with Benadryl and cold packs.
chills; headache; low grade fever; body aches; Initial information regarding an unsolicited valid non-serious case received from a consumer (patient) via social media on 05-Dec-2020.  This case involves a patient of unknown demographics who experienced chills, headache, low grade fever (Pyrexia), body aches (Pain), while the patient received Influenza Vaccine.  The patient's medical history, medical treatment(s), vaccination(s) and family history were not provided.  Concomitant medication was unknown.  On an unknown date, the patient received a dose of suspect INFLUENZA VACCINE produced by unknown manufacturer (lot number and expiration date were not reported) via unknown route in unknown administration site as prophylactic vaccination.  On an unknown date, the reporter stated that he/she always had side effects the day of the vaccine, chills, headache, low grade fever (Pyrexia), body aches (Pain), same with pneumonia, next day he/she was fine.  Action taken was not applicable.  It was not reported if the patient received a corrective treatment.  The event outcome was resolved next day.  There will be no information about the batch number in this case.  The reporter assessed the causal relationship with suspect vaccine as related.  No further relevant information was reported.
Left upper arm swollen, warm to touch, redness began night of vaccine given and worsened over the next morning.
Patient received vaccine in vaccination room. Upon walking out patient was dizzy and fell into the end of a shelf with his mother helping to keep him from completely falling. Patient did not hit head. After the patient was caught he sat in a chair upon arrival of the EMS.
Diagnosed with cellulitis in left arm. Left arm swollen, red and warm to the touch. Symptoms on May 9-May 11 were fever, body aches, mild headache and eyes and nose running.
Headache, Myalgia, Fever & Tachycardia Narrative:  Other Relevant History:
Information has been received from a registered nurse concerning a 20 month old male who on 20-JUL-2005 was vaccinated SC in the left thigh with a first 0.5 ml dose of Varivax (lot # 650224/1107F). Concomitant vaccination included a 0.5 ml first dose of MMR II (lot # 646857/0850F) and a 0.5 ml fourth dose of Prevnar (lot # A67185K). On 27-MAR-2006 the patient developed breakthrough chickenpox disease. Unspecified medical attention was sought. Subsequently, the patient recovered. No further information was available. The patient's additional vaccination history includes: First, second, third, and fourth doses of Infanrix on 14-SEP-2004 (lot # AC21A003BA), 24-NOV-2004 (lot # AC21A005AA), 12-JAN-2005 (lot # AC21A010CA), and 01-DEC-2005 (lot # AC14A007AA) respectively. Doses of Fluzone on 12-JAN-2005 (lot # U1557AA) and 01-DEC-2005 (lot # U1916AA). First, second, third, and fourth doses of Prevnar on 14-SEP-2004 (lot # 495-932), 24-NOV-2004 (lot # A57561A), 12-JAN-2005 (lot # A74399D), and 20-JUL-2005 (lot # A67185K) respectively. One dose of hepatitis B virus vaccine (manufacturer unspecified) on 08-JUL-2004. Additional information is not expected.
Patient got ZOSTAVAX vaccine on 6/3/14 evening. On 6/4/14 in the evening, she developed itchiness. Patient scratched the area for relief on Thursday 6/5/14 the area became swollen and hot.