chrisvoncsefalvay/vaers-outcomes huggingface dataset:
pt became very dizzy & pale about 15mins p/vax; mom brought back in & pt fainted; p/using ammonia became alert 2-3 mins & proceded to faint again; pt semi-alert for 2-3mins & fainted again; pt rigid & incontinent of urine, pale, weak;
Extensive limb swelling and erythema of left upper lateral/posterior arm down to elbow without limitation to movement of joints (examined in clinic 21 DEC 2020 in the AM). No treatment had been initiated at that time. Recommended treatment with cool compresses and ibuprofen moving forward.
Dizzy; Vomiting; This spontaneous case was reported by a consumer and describes the occurrence of DIZZINESS (Dizzy) and VOMITING (Vomiting) in a 53-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No medical history was not reported by the reporter.  Concomitant products included ONDANSETRON (ZOFRAN [ONDANSETRON]) for an unknown indication.    On 03-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. In February 2021, the patient experienced DIZZINESS (Dizzy) and VOMITING (Vomiting). At the time of the report, DIZZINESS (Dizzy) and VOMITING (Vomiting) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Treatment details was not reported by the reporter.
pain swelling of site and hot to touch.  Woke up with bad headache and my whole body hurt.  Felt like I was run over by a truck.  bouts of freezing then burning up all that lasted for 24 hours still sore and swollen and red and hot today but don't feel like I was hit by a truck.
Chills, headache, nausea (comes/goes in waves)  and at injection site swollen, sore and red
Second vaccine has been administered 14 days after the first dose; This spontaneous case was reported by a pharmacist and describes the occurrence of INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Second vaccine has been administered 14 days after the first dose) in a 74-year-old patient of an unknown gender who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 003B21A) for COVID-19 vaccination.     No Medical History information was reported.   On 31-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 14-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 14-Apr-2021, the patient experienced INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Second vaccine has been administered 14 days after the first dose). At the time of the report, INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Second vaccine has been administered 14 days after the first dose) had resolved. Not Provided      For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   No concomitant medication reported
Woke with stomach upset and headache. Fell asleep again until 8 AM and began to have loose stool and vomited. Loose stool turned to diarrhea. Dry heaved a few more times and vomited a second time. Still having symptoms but mostly diarrhea.
Narrative: Patient experienced hypersensitivity reaction to Pfizer COVID-19 vaccine. Treated with diphenhydramine and topical moisturizing cream. Symptoms resolved without intervention. Dose #2 of vaccine series was not given.
The next morning patient woke up with dry mouth, pain all over her body with rash on her neck, chest and her  back (the whole back). Patient denied any rash on extremities or legs. Patient advised to take Benadryl and call primary care provider. not outcome has been reported.
Treatment of COVID-19; Treatment of COVID-19; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 51-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 15Dec2021 as dose 3 (booster), single (Lot number: FD7218) at the age of 50 years, in left arm for covid-19 immunisation; coviD-19 vaccine (COVID-19 VACCINE), as dose 1, single (Batch/Lot number: unknown) and as dose 2, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history included: "Known allergies: shrimp" (unspecified if ongoing); "Known allergies: mildly strawberry/pineapple" (unspecified if ongoing). The patient's concomitant medications were not reported. Past drug history included: Amoxicillin, reaction(s): "Known allergies: Amoxicillin". The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant) all with onset Oct2022, outcome "not recovered" and all described as "Treatment of COVID-19". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: Positive, notes: Rebound COVID. Therapeutic measures were taken as a result of drug ineffective, covid-19.
10/10 1PM got shot. Midnight woke up with severe flu like symptoms 10/11 evening boyfriend called asking if normal. Trouble breathing recommended go to ER.
Experienced re, sore throat, headache, fatigue for 2 weeks, l/arm soreness.  Tx - Tylenol.
IMMUNIZATIONS WERE GIVEN ABOUT 15 SECONDS APART IN THIS ORDER, VARICELLA, HAPATITIS A, FLUMIST. THE INJECTIONS WERE GIVEN IN THE LEFT DELTOID (HEPATITIS A) AND SUBCUTANEOUSLY NEAR LEFT DELTOID (VARICELLA). THIS IS THE PATIENTS SECOND DOSE OF BOTH INJECTIONS. THE FLUMIST WAS GIVEN INTRANASALLY. APPROX. 5 MIN AFTER IMMUNIZATIONS WERE GIVEN, THE PATIENT STOOD UP AND WALKED A FEW FEET BEFORE SAYING SHE FELT DIZZY AND SLUMPING TOWARD HER MOTHER. PT WAS CARRIED BACK TO THE EXAM TABLE BY HER MOTHER AND I. PT REMAINED CONCIOUS AND BREATHING, PT DID EXPERIENCE PALLOR AND NAUSEA AND WAS ABLE TO SIT UP AFTER ABOUT 20 SECONDS. PT WAS GIVEN A DRINK AND BP WAS 100/60 @ THIS TIME. PT WAS ALERT AND ORIENTED X3. PT AND MOTHER WERE ASKED TO STAY FOR OBSERVATION FOR ANOTHER 15 MIN AND THEY AGREED. PT LEFT IN NO APPARRENT DISTRESS OR DISCOMFORT.
Patient  is going through menopause and has not had a menstrual cycle since December 2020. On July 12, patient started spotting in the afternoon with a moderate discharge on the July 13. On July 14, patient's symptoms have become worse with very heavy bleeding. Patient did message her doctor to let her know what was going on.
Nausea and probable fever, "felt hot, sweaty, blurry vision and lightheaded ness." reported to school nurse on 03/26/2002.
tachycardia 150 beats per minute, 40 times in 24 hours
This spontaneous reprot was received from a 54 year female consumer reporting on herself as part of a market research program. Patient's medical and concurrent conditions were not reported. In summer of 2014 (in approximately June 2014), the patient was vaccinated with a dose of ZOSTAVAX (route, site, lot # and expiry date not reported). The patient reported that after she was vaccinated, she experienced very minor soreness at injection site. After approximately 12 hours of onset of soreness at the injection site the patient took over the counter inflammatory. The outcome of injection site pain was reported as recovered/resolved within 48 hours. The reporter considered injection site pain to be related to ZOSTAVAX. Additional information is not expected.
3FEB97 t101.7, chest congestion, wheezing, non productive cough-robitussin PM/Zithromax x 5 days;4FEB97 t102.1;re-vax on 7FEB97;
This literature market report has been received from authors of a published article. This report referred to a male patient of unknown age with recurrent respiratory papillomatosis and pulmonary involvement. The patient's initial diagnosis was made during infancy when bronchoscopy for hoarseness revealed airway papilloma. He had extensive laryngeal involvement with significant scarring of the larynx from multiple debridements, which also resulted in an unrecognizable left arytenoid and vocal cord. At two years of age, worsening airway obstruction led to a tracheostomy at an outside institution and two years later, the patient had laryngotracheoplasty with decannulation. The patient continued to have multiple debridements with a microdebrider every 6-8 weeks. On an unknown date the patient was vaccinated with intralesional injection of mumps vaccine (unspecified, manufacture unknown) (strength, dose detail, lot # and expiration date were not reported) for recurrent respiratory papillomatosis. As it reported, the patient has no improvement. Pulmonary parenchymal involvement was discovered on chest computed tomography (CT) at 13 years of age. Two months prior to referral, pulmonary function declined with FEV1/FVC 74% from his baseline of 90-100% and flattening of his inspiratory flow loop. Exam revealed a prolonged inspiratory phase, clear breath sounds and productive cough. Azithromycin three times a week, mometasone/formoterol and levalbuterol were continued and airway clearance initiated. Discussion between pulmonology, otorhinolaryngology, infectious disease and oncology led to a trial of systemic bevacizumab which was initiated at 10 mg/kg intravenously (IV) every 3 weeks for 3 months. Repeat chest CT scan after 3 months showed resolution of his pulmonary nodule within the anterior segment of the left lower lobe and no new lesions. No airway debridement was required until 6 months after initiation of bevacizumab. The patient then underwent a left endoscopic partial arytenoidectomy for worsening dyspnea on exertion, resulting in improvement of his breathing and spirometry.
"Large hives & redness from (R) shoulder to elbow 101.0 F fever; swelling, pain," pt applied "NEOMYCIN & took TYLENOL & applied ice" "called PCP who advised her to do this" this ARNP recommended BENADRYL date occurred 8/30/31 came to clinic in person on 09/01/12.
MODERNA Vaccine results: Headache on day 2,3,4 after administered on Jan. 14; Itchy and red patch appeared on left arm at vaccine site that was about 1 inch square that appeared on day 8 after administerd, on day 9 the red had doubled in size, on day 10 the size had tripled, continuing to be itchy and bright red, with a temp of 99.3 to 99.5.  On day 11, the red was diminishing, no fever noted.
5 min into the vaccine my heart began to beat faster.  30-40min later I began to have heart burn (mild midsternal chest pain) that lasted 3 hrs. I also have mild body aches and pain at the insertion site.
Patient seen in the office 8/1/22 complaining of left arm pain and redness. Stated that she got vaccine on 7/27/22 and had a small circular area around the injection site but then on Saturday the reddened area quickly spread. Patient seen by PCP and given course of antibiotics.
Had an autoimmune response causing Rheumatoid Arthritis. Multiple joints swollen (fingers, thumbs, wrists, shoulders, knees), swelling and warmth, stiffness, and excruciating pain. Primary care Dr. sent him to a Rheumatologist where he is still being treated. The first medication he tried was Methotrexate, but he developed a severe cough and couldn't take it. He is now taking ENBREL injections weekly.
Symptoms were mild and similar to a common cold. I was at a conference between the 12th and the 16th of July. It started with a mild cough. I felt fine. I thought it was allergies. By the 18th of July the symptoms were getting stronger so I took an at home test and it came back negative. On the 19th of July, I had a cough and congestion and 2 days later it developed to weakness, shaky, and I had trouble breathing. My smart watch was saying my heart rate was weirdly up as if my body was fighting something. Then I went to urgent care but they turned me away and I had to go to the ER and they did an EKG and lab work, which included the swab for COVID and that came back positive. They gave me Paxlovid and sent me home. I feel a lot better now although my voice is still a little hoarse and I have a bit of a cough, but nothing to severe.
Was having one yellow seedy stool a day after mother eliminated airy in diet, exclusive breastfed. Previously had gross blood (occasional) loose and mucusy stools. After getting vaccines stools daily mucusy, one time with gross bld one stool a day. Breastfed. TX->increase ZANTAC observe for worsening. Cont. restrict dairy in diet. Continue exclusive breastfeeding.
At 4am woke up with fever (103.8), chills, body aches.  Used Motrin to control fever and body aches.
60yo F w/ hx breast cancer in remission, cirrhosis due to alcohol reportedly sober since 1/2022, and inflammatory arthritis on plaquenil admitted with FTT- decreased PO intake she said was due to having so much phlegm swallowed that it made her nauseated. Phlegm improved, still didn't eat. Resultant marked electrolyte abnormalities on admission with weakness. Also feeling "jittery". Exam pale w/ soft abdomen. Ascites fluid not consistent w/ dialysis and CXR clear, but markedly elevated procalcitonin is concerning. Therefore will continue rocephin and add doxy for now in case occult pneumonia vs SBP and await cultures/follow clinically. Check u/s + AFP to make sure no HCC causing FTT. Also w/ hx of esophageal rings s/p dilations, could consult GI for consideration for endoscopic dilation as she has noted more difficulty swallowing recently.      Other consideration is something like depression/anxiety causing the FTT. Says she is taking her medications, but hasn't been making in person appointments recently. Was assaulted by a neighbor in her apartment in early March per therapy notes so I think this is probably contributing to her current presentation. Also I am not certain she is maintaining her sobriety- but I think she probably is mostly telling the truth- would expect her phos to be lower and her lfts to be up more if she had started drinking regularly again. Consider psych consult for further med recs- she has prolonged qtc which limits ssri- not sure her SNRI is helping much.  Tested positive for COVID upon admission (3/22/22).
This spontaneous report was received from a consumer referring to a female patient of unknown age. The patients' concurrent conditions, concomitant therapy, medical history and historical drugs were not reported. On an unknown date in February 2018 (reported as approximately a month ago), the patient was vaccinated with PNEUMOVAX 23 (strength, dose, frequency, route of administration, lot # and expiry date were not reported) for pneumococcal infection. On an unknown date in February 2018, within hours after the vaccination (also reported as immediately afterwards), the patient's entire upper arm (left or right arm unspecified) became swollen with a yellow tint for unspecified amount of days. The events outcome was unknown. No product quality complaint was involved. Causality assessment was not provided.
Patient complains of bruise on her right arm around the area injection was given and not being able to raise up arm above shoulder.
Second shot in right upper arm. The next day I had alot of swelling and discomfort in my right arm pit.
Prepared w/needle attached on 10/12/22, given until 10/23/22; This case was reported by a nurse and described the occurrence of wrong technique in device usage process in a patient who received Flu Seasonal QIV Quebec (FluLaval Quadrivalent 2022-2023 season) for prophylaxis.   Co-suspect products included flu seasonal qiv quebec pre-filled syringe device (Flulaval Tetra Pre-Filled Syringe Device) injection syringe for prophylaxis.   On 23rd October 2022, the patient received FluLaval Quadrivalent 2022-2023 season and Flulaval Tetra Pre-Filled Syringe Device. On 23rd October 2022, unknown after receiving FluLaval Quadrivalent 2022-2023 season and Flulaval Tetra Pre-Filled Syringe Device, the patient experienced wrong technique in device usage process. On an unknown date, the outcome of the wrong technique in device usage process was unknown.   This report is made by GSK without prejudice and does not imply any admission or liability for the incident or its consequences.   Additional Information: GSK Receipt Date: 04-NOV-2022 Reporter's comment: The patient had given a dose of FluLaval Quadrivalent 2022-2023 season that had been prepared on 12th October 2022 but was not given until 23rd October 2022. The reporter was seeking information about how to proceed.  The reporter stated that a needle had been applied to the syringe on 12th October 2022. The syringe was stored in a temperature controlled refrigerator. The reporter consented to follow-up. Additional Supportive Information: The patient had been given a dose of FluLaval Quadrivalent 2022-2023 season that had been prepared on 12th October 2022 but was not given until 23rd October 2022, which led to wrong technique in device usage process. The case US2022161284 was identified as duplicate of this case. The case US2022161284 was deleted and all future correspondence would be added in the present case which stands as case of record for this patient. This case had been linked with case US2022161279, reported by the same reporter.; Sender's Comments:  US-GSK-US2022161279:Same reporter
Low to zero energy. Low body temperature under 93 Sweating with little activity Still going on
Did not feel well after vaccination.  SOB on 3/28/2003.  Intermittent chest pain until 3/30/2003.  Admitted to Hospital 3/30/2003 pm.  Chest pain experienced at church.
arms and back hurt along with feeling tired and cold low grade fever, headache, body aches, diarrhea, fatigue and a coughing, which is minimal and sometimes productive  doxycycline Augmentin
The patient developed shortness of breath on 29 MAY 2021, 5 weeks after the 2nd vaccine dose.  Two months later, the patient developed left leg pain on 30 JUL 2021 and worsened shortness of breath on 11 AUG 2021, when he was subsequently diagnosed with both a DVT and pulmonary embolism.
Abdominal pain was on 3rd day. Still feel back pain after receiving vaccine. Black stool from 3rd day of vaccine.
I went home and had 2 seizures right after I got 2 of my vaccinations. I had received all 3 vaccinations, and I need proof of that.; This is a spontaneous report received from a contactable reporter(s) (Other HCP). The reporter is the patient.  A 36-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), in 2021 as dose 2, single (Batch/Lot number: unknown), in left arm for covid-19 immunisation. The patient's relevant medical history included: "Epilepsy" (unspecified if ongoing). The patient took concomitant medications. Vaccination history included: Bnt162b2 (Dose 1, Single, Batch/Lot No: Unknown. Misplaced/discarded, Location of injection: Arm Left), administration date: 2021, for COVID-19 immunization, reaction(s): "seizure". The following information was reported: SEIZURE (disability, medically significant) with onset 2021, outcome "not recovered", described as "I went home and had 2 seizures right after I got 2 of my vaccinations. I had received all 3 vaccinations, and I need proof of that.". The events "i went home and had 2 seizures right after i got 2 of my vaccinations. i had received all 3 vaccinations, and i need proof of that." required emergency room visit. It was unknown if therapeutic measures were taken as a result of seizure.  Clinical course: Patient reported that she went home and had 2 seizures right after she got 2 of her vaccinations. She had received all 3 vaccinations, and She need proof of that. No know allergies. Received other medications in two weeks. Received other vaccine in four weeks.   The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.; Sender's Comments: Based on known drug safety profile, there is reasonable possibility of causal association between the event "SEIZURE " and BNT162B2. 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.
Fever; This spontaneous case was reported by a patient and describes the occurrence of PYREXIA (Fever) in a patient of an unknown age and gender who received mRNA-1273.815 (SPIKEVAX 2023-2024) for COVID-19 prophylaxis.     No Medical History information was reported.  On an unknown date, the patient received dose of mRNA-1273.815 (SPIKEVAX 2023-2024) (unknown route) 1 dosage form. On an unknown date,  after starting mRNA-1273.815 (SPIKEVAX 2023-2024), the patient experienced PYREXIA (Fever). At the time of the report, PYREXIA (Fever) outcome was unknown.      Concomitant medication was not reported.  It was reported that events occurred 8 hours post vaccination and fever was undocumented.   Treatment medication was not reported.
On 04/25/2000 the patient experienced herpes zoster on the right thigh in a linear distribution. The patient was afebrile. Subsequently, the patient recovered. There had been no recent exposure to chickenpox or to shingles. PCR analysis indicated the vesicular specimen from the herpes zoster rash was adequate, however it was negative for VZV. No further information is available.
Per EMS, patient hypotensive (no vitals recorded in report). Patient observed to be shaking, blood glucose 125 per EMS. She initially declined transport but spoke to the medical unit and agreed to be transported. Per EMS, IV with normal saline started. She denies pregnancy.  BP observed in ambulance as 140/90, HR 123, PSO2 98%.  Transport at patient's request.
After administering the vaccine, the patient waits standing while I administer the vaccine to his sister. Quickly the patient collapses and falls to the ground. The patient is pale and sweaty. Alert and oriented patient reports feeling dizzy. She was assisted with the help of some colleagues to lift her off the ground and lie down on a stretcher in a supine position. Vital signs were taken: B/P 100/50, P 75, R. 26, Sat. 99 and dext 88mg/dl. The patient was kept under observation at all times and Pediatrician was notified.
Patient, who used to frequently consume seafood/shellfish, developed an allergy to seafood and shellfish 1 day after vaccine administration. Patient reports to have consumed shrimp 1 day after receiving the vaccine. After eating the shrimp, the patient then developed a skin rash on her upper and lower extremities as well as numbness in the lips. The origin of the rash is unknown, but the patient exclaims the rash did not start on the arm in which the vaccine was injected. The patient also reports trying saltwater fish and shrimp flavored ramen soup after the vaccine on future unknown dates. She experienced the same allergic reaction (skin rash and numbness in the lips) from the seafood thereafter. Benadryl was used to combat the allergic reaction.  The patient has consumed seafood/shellfish for all of her life and has never experienced any allergic reaction before vaccine administration. The patient was advised to contact an allergy specialist before consuming  any seafood/shellfish in the future. Patient also reported having a son with seafood/shellfish allergy.