chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Mother called at 14:00 today and stated she works in a daycare and the pt attends and there has been cases of varicella. He didn't complain of fever but started breaking out under arms, buttocks, behind ears, penis and back. Red, blisters, yellow fluid inside and itching. He has decreased appetite and tired. Received varicella on 8/20/97.
Administer expired vaccine to 450 patients after the manufacture date of expiration; This spontaneous case was reported by an other health care professional and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Administer expired vaccine to 450 patients after the manufacture date of expiration) in a 78-year-old female patient who received mRNA-1273 (Spikevax) (batch no. 070H21A) for COVID-19 vaccination.     No Medical History information was reported.    On 13-Apr-2022, the patient received dose of mRNA-1273 (Spikevax) (unknown route) 1 dosage form. On 13-Apr-2022, the patient experienced EXPIRED PRODUCT ADMINISTERED (Administer expired vaccine to 450 patients after the manufacture date of expiration). At the time of the report, EXPIRED PRODUCT ADMINISTERED (Administer expired vaccine to 450 patients after the manufacture date of expiration) outcome was unknown.        For mRNA-1273 (Spikevax) (Unknown), the reporter did not provide any causality assessments.   No concomitant medications were reported  No treatment medications were reported  It was unknown if the vial was initially stored in the refrigerator The vial did not undergo any temperature excursions   Most recent FOLLOW-UP information incorporated above includes: On 08-Jun-2022: Follow up received contains Non significant information.
This spontaneous report as received from a pharmacist refers to a 70 year old female patient. The patient's pertinent medical history, drug reactions/allergies were not provided. Three or four years ago, approximately in 2010, the patient was vaccinated with a dose of ZOSTAVAX (route, lot number and expiration date were not provided). Co-suspect therapy and concomitant medications were not provided. It was reported that last year, in 2013 the patient was diagnosed with a mild case of shingles. It was unspecified if patient received any treatment for the event, or if the patient performed any lab diagnostic test. On an unspecified date, the patient recovered from adverse event. The relatedness between the event and suspect therapy was not provided. Additional information has been requested.
COVID-19 confirmed by positive COVID-19 test; COVID-19 confirmed by positive COVID-19 test; This is a spontaneous report from a contactable consumer (patient) via a patient of unspecified age and gender received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) dose 1 via an unspecified route of administration on an unspecified date (Batch/Lot number was not reported) as 1st dose, single for covid-19 immunisation. The patient medical history and concomitant medications were not reported. The patient received the first dose of covid vaccine 3 weeks ago and recently diagnosed with covid on an unspecified date with outcome of unknown. The patient underwent lab tests included covid-19 positive on an unspecified date.  Information on the lot/batch number has been requested.
Painful shoulders, Pain in back of both hands. Pain in left buttocks. Pain in left side of neck
High fever of 103, diffuse body aches, cough, nausea, light headedness, headaches
Within 12 hours-mild chills and sore arm; within 36 hours- severe nausea and dizziness when I tried to get out of bed, had to crawl to bathroom, chills, very sore arm, redness and swelling at injection site. Had to stay in bed for 2 days. Swelling, redness and arm lasted for several days. Dizziness and nausea has slowly improved but after 4 mos I still have some dizziness when I roll over in bed or get up out of bed. I also have some dizziness when I lay flat on floor to exercise. It last about 5 secs.
She had the shot on March 17,2021 and not even a week later on March 22,2021 she was having difficulty breathing so we took her to the emergency room and they couldn?t tell us what was wrong with her ..she ended up on the ventilator till April 26,2021 and then they performed what they call tracheotomy to wing her off the trach and now she?s in a rehab facility trying to relearn everything
No symptoms reported; Unspecified number of patients have recieved improperly stored ROTATEQ on unspecified dates; Inappropriate age at vaccine administration; This spontaneous report was received from a nurse, referring to a neonate female patient. There was no information about the patients' concurrent conditions, concomitant therapies or medical histories provided.  On 13-AUG-2018, the patient was vaccinated with the first improperly stored dose of rotavirus vaccine, live, oral, pentavalent (ROTATEQ) (lot number S004251 with expiration date: 22-SEP-2020; dose, strength and route of administration) for prophylaxis (product storage error and inappropriate age at vaccine administration). On 17-DEC-2018 and 08-FEB-2019, the patient had received the rest two doses of rotavirus vaccine, live, oral, pentavalent (ROTATEQ) (strength, dose, route of administration, lot# and expiration date were not reported).No symptoms reported.  Administered dose of rotavirus vaccine, live, oral, pentavalent (ROTATEQ) underwent temperature excursion of 46.9 degrees Fahrenheit (F) for 55 minutes. Data logger was involved. The previous temperature excursion was 34.9 F for 25 minutes and 48.6 F for 25 minutes.; Sender's Comments:  US-009507513-1911USA004865: US-009507513-2005USA007561: US-009507513-2005USA007562:
tested positive covid-19 on 6/22/2021 despite having completed covid vaccine series
Had a seizure at home then called 911 and the ambulance took her to hospital, where she had a second seizure.
Vaccine went into 2-8 Celsius thaw state on or about 24-Dec-2021 and administered on 04-APR-2022; Vaccine received post its 30 days Expiry date; This spontaneous case was reported by an emergency medical technician and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Vaccine received post its 30 days Expiry date) and PRODUCT STORAGE ERROR (Vaccine went into 2-8 Celsius thaw state on or about 24-Dec-2021 and administered on 04-APR-2022) in a 70-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 066H21A) for COVID-19 vaccination.     No Medical History information was reported.    On 04-Apr-2022 at 5:29 PM, the patient received fourth dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) .25 milliliter. On 04-Apr-2022 at 5:29 PM, the patient experienced EXPIRED PRODUCT ADMINISTERED (Vaccine received post its 30 days Expiry date). On an unknown date, the patient experienced PRODUCT STORAGE ERROR (Vaccine went into 2-8 Celsius thaw state on or about 24-Dec-2021 and administered on 04-APR-2022). At the time of the report, EXPIRED PRODUCT ADMINISTERED (Vaccine received post its 30 days Expiry date) and PRODUCT STORAGE ERROR (Vaccine went into 2-8 Celsius thaw state on or about 24-Dec-2021 and administered on 04-APR-2022) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   Concomitant medication of the patient was not reported.  Vaccine administration time was given as 04-Apr-2022 17:29:33. Patient was administered a second booster dose.  No treatment information was provided by the reporter.   This case was linked to MOD-2022-542869 (Patient Link).
temp to 105 w/febrile convuls; seen in ER; CBC-blood culture done
Pronounced muscle weakness in torso (unable to sit upright, bladder incontinence), pronounced dyskinesia (unable to lift food with a fork from plate to mouth), fatigue. Started approximately 6 p.m. on 7/23/2022, or 22 hours after I received my 4th dose (2nd booster) of Covid-19 vaccine. I had Pfizer for the first 3 doses; this was my first experience with Moderna. I went to bed at 8 p.m. and slept fitfully until noon the next day.
On the eight day from vaccine given, my right arm has developed a red rash around the injection site.  I didn't have any symptoms for the first seven days.
Narrative:  COVID infection after completion of COVID vaccine series: 03/02/2021 COVID vaccine dose #1 03/23/2021 COVID vaccine dose #2 07/12/2021 Pt reported onset of productive cough (clear sputum), SOB, congestion, myalgia, N/V, and diarrhea. Stated that friend visited and also tested COVID positive. 07/15/2021 Pt presented to ED c/o continuation of above sx 07/15/2021 COVID positive per nasopharyngeal swab 07/16/2021 Pt reported onset of chills and HA, continuation of other sx 07/17/2021 Pt c/o rhinorrhea 07/18/2021 Pt c/o HA 07/19/2021 Pt reported experiencing severe HA and insomnia. Pt stated taking prednisone with dinner. Pt educated by HCP to take med in the morning with breakfast. 07/20/2021 PCP prescribed melatonin to help with insomnia 07/20/2021 Clinical resolution of COVID infection per CDC guidelines
Complication of immunization (disorder). I think two problems: Localized reaction to Hep A. Generalized rash; looks like a viral exanthema. It's possible that it was after MMRV. She does not looks 'sick' or 'septic. --AUGMENTIN po; -- if any concern or not getting better then go to ER ASAP; F/U in 3 days.
It started with tingling in my lower parts of body, restless leg symptom, stomach problems, spasms in my back, numbness in the toes, feeling of buzzing sensations throughout my body, dry mouth, fatigue, burning when being active, heart palpitations, brain fog, dizziness and severe headaches. I have tinnitus in the right ear and sun sensitivity.
On Sun 12/27 around 12pm I had left arm tenderness and I was fatigued and then at 5pm I had a fever starting at 99.5 and by 11pm 103.5 I had body aches chills, rigers, fever did not break with tylenol or advil . I had the fever until Monday afternoon and it broke for a few hours and came back and did not budge from 101. I called occupational health and asked questions about my fever, monday night at 8pm I had a bad dry cough and SOB and chest tightness and sinus congestion, no sneezing or runny nose, still with a fever. I called occupational health again and they said to come in to get covid tested and results were positive Tuesday 29th AM. On Thursday I started taking medicine: 5 day course of singulair, slow vent albuterol prn teflex antibiotic and calcium, Zinc and  Vitamin D. The fever started to break around Monday the1st to the 4th around 99 to 100 . The 4th  I lost sense of taste and smell and Monday the 28, 2020 I had neuromuscular pain in stiffness in legs and I had trouble walking and when fever got lower I realized I was having pain in my feet and hips. I think the infection triggered the unknown neuromuscular condition. I was supposed to go to work the 11th but since I was still having leg issues and my leave was extended one more week. I do not believe these reactions were due to the vaccine I think it was just a coincidence I contracted COVID prior to getting the vaccine
I tested positive for COVID-19 on April 09, 2023 my symptoms were aches, coughs, & fatigue and had a headache for a few days. I was taking Tylenol and Ibuprofen.
Left retrobulbar optic neurtis of the left eye post vaccination 10 days -2 weeks; Vision loss is reported as sudden in onsent and constant in the left eye per patient; This is a spontaneous report from a contactable physician. A 22 years old female patient received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Batch/Lot Number: EL1284) at the age of 21 years via intramuscular, administered in arm left on 18Jan2021 08:45 as single dose for covid-19 immunisation. Medical history included heart murmur, history of COVID-19 in Oct2020. Patient is not pregnant at the time of vaccination. The patient's concomitant medications were not reported.  Patient previously received first dose of BNT162B2 (Lot number: ek5730) at the age of 21 years via intramuscular, administered in arm left on 28Dec2020 as single dose for covid-19 immunisation. Patient has not received any other vaccines within 4 weeks prior to the COVID vaccine, nor received any medications within 2 weeks of vaccination. Left retrobulbar optic neuritis of the left eye post vaccination 10 days -2 weeks since 31Jan2021 08:00 AM. Patient had IV steroid infusions for 5 days, oral steroids to follow. Tapered down from 75mg prednisone. Patient had to have MRI. Vision loss was reported as sudden in onset and constant in the left eye per patient. Patient visited doctor office/clinic or emergency room and requiring urgent care. Treatment included infusions, prednisone, MRI. Patient has not tested COVID post vaccination. Outcome of the events was recovering.; Sender's Comments: A possible contributory effect of suspect BNT162B2 on reported events cannot be excluded.  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.
It began with muscle soreness at the site.  A headache followed within about 5 hours and continued for a couple of days.  I slept for 13 hours after I had received the shot and felt groggy/tired for 2 days. On Monday morning 3/15/21 when I stood up that morning my lips began pursing as if I were kissing someone, this happened for about 30 seconds.  I was shocked as I couldn't control my lips and make them stop.  the headache and brain fog continued for about a week.
HYPOTENSION 4/27/2022  &  1/15/2023  --  RECURRENCE OF HOSPITALIZATION WITH SAME SYMPTOMS
Rash developed on patient's face and had begun spreading downward with fever up to 101 no other complaints. Rash described as erythematous maculopapular. No intervention recommended at this time.
PATIENT SUPPOSED TO RECEIVE 2ND DOSE OF PFIZER HOWEVER RECEIVED JANSSEN.
Pt exp vomiting, lethargy 24-72 hrs post vax; no fever; 8 days post vax gait unsteady, legs weak, unable to climb stairs for 2 1/2 days; Now 12 days post vax adm., slight effects-full recovery expected;
3 hours after injection feet fatigue, 4 hours after injection temp 99 degrees, 5 1/2 hours after injection chills temp 100 degrees, 7 hours after injection temp 101.5, stiff neck, labored breathing, dizzy, nausea, fatigue. Symptoms continue 4 days later.
Twelve hours after receiving the vaccine, I experienced: headache, joint pain in all joints, chills, fever, quite severe pain at the injection site. Weakness and fatigue. Redness around the injection site. These symptoms continued for 5 days. Two days after the vaccine, my back began to itch. Luckily, my boyfriend was here and told me my entire back had a chicken pox type, raised rash. Over my entire back and shoulders.I have had, now, six days of pretty unbearable itching. It is being treated with essential oils, CBD lotion (helps the most), and Desitin. Additionally worth reporting, three days after the vaccine, I went on a short walk on flat streets. I normally hike six miles so this should have been easy. My knees felt like they were locked. I typically play golf and tennis...never felt this before.In the past, I have had reactions to flu shots, no breathing issues, just instant feeling of being really sick which lasted for days. I did not want to take this vaccine but there is so much hype to take it I did. I prefer to stand by healthy living and exercise are the best preventative at this stage of my life.Only other piece I can add....I think my boyfriend had Covid back in February of 2020. He had all symptoms.This was before we knew what was going on. I was ill 2 weeks after his illness. It was an odd respiratory cough and fatigue and that was it. Today is one week post second vaccine. I am finally getting energy back. My back still a massive rash itching horribly. I sure hope I haven't done the wrong thing.
Fatigue; Headache; Worsening muscle pain; Worsening joint pain; Chills; This is a spontaneous report from a non-contactable consumer, the patient. A 28-year-old non-pregnant female patient received unknown dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: UNKNOWN) via an unspecified route of administration on 07Apr2021 at 10:45 (at the age of 28-years-old) as a single dose for COVID-19 immunisation. Medical history and other medications received within two weeks prior to vaccination were not reported. Prior to the vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. The patient did not receive any other vaccines within four weeks prior to the vaccination. On 07Apr2021 at 23:45, the patient experienced fatigue, headache, worsening muscle pain, worsening joint pain and chills. The clinical outcome of the events fatigue, headache, worsening muscle pain, worsening joint pain and chills was unknown at the time of this report.   No follow-up attempts are possible; information about lot/batch number cannot be obtained.
pt recv vax 17SEP97 & the next day pt exp an inj site rxn consisting of a 3-4inch red welt, irritation & itching;
Seen in ER on 9/17/22:  A red, erythematous rash spreading from the proximal thigh (from puncture site of Pneumovax vaccination) to the knee; consistent with cellulitis.  Mild swelling along the progression of the rash; is not firm or indurated. There is mild swelling overlying the left knee. Range of motion is limited secondary to pain; unable to fully flex the left knee secondary to pain, is able to fully extend. No pain with range of motion of the left ankle or left hip. Examination findings most consistent with cellulitis especially in context of fever. Did also consider delayed reaction after receiving Pneumovax vaccination; however given fever less likely..  Treated with 7 days of Keflex.
Vaccine received in first trimester of IVF pregnancy with a female, genetically tested normal embryo. Fetus discovered to have no heartbeat, with growth estimated to have ceased 2.5 weeks after vaccine. Fetus measured 11w6d at time of death. D&C performed on 4/2/2021 and fetus tested for abnormalities, with all results returned as normal.
On 12/14/2022 at 2pm, patient noticed three red blotches on left arm below deltoid that was warm to the touch.  Her arm was hurting and was unable to lift past shoulder height.  On the evening of 12/15/2022, patient came to pharmacy and rash was tender and about a 5 inch circle with a hard knot in the middle.  Patient went to medical clinic and was prescribed antibiotics.
PATIENT IS REPORTING FATIGUE, TROUBLE BREATHING, JOINT PAIN, INSOMNIA, FEVER, AND OTHER LINKED SIDE EFFECTS FROM NATIONAL AD CAMPAIGN.
10/13 Injection to top of left shoulder. 10/19 Increasing pain and swelling in shoulder joint. 10/23 Tingling and numbness side of hand and two fingers. 10/24 Tingling and numbness entire hand. 10/24 GP prescribed METHYLPRED 4mg.
I woke up the next morning and felt like my head was in a vice. My head hurt all over. I had a cup of coffee and something to eat and then took 3 Advil. I went back to bed and slept till around 12:45 pm! I did feel better once I woke up. About 75%. This morning, Monday, 4/12/2021, I notice I have a red mark several inches below and several inches towards the front of my arm away from the injection site. It isn't hard or swollen but it is a bit sore/sensitive. But today I do feel 100%.
2/18/22 debilitating migraine, progressed to nausea and vomiting. Rash on torso began over the weekend and then running up neck/throat area. Took Benadryl Sunday and was feeling some better Monday 2/21/22. Completely gone 2/22/22.
Caught COVID from an exposure on 8/17, experienced symptoms (fatigue, sinus pressure) on 8/19  Symptoms were resolved by 8/28.  Main symptoms: headache, fatigue, minor chest pain, aches, chills, sinus pressure, cough
The patient received two Pfizer-BioNTech vaccines; dates and lot information and administration site of vaccines are not available at the time of this report.  The patient presented to Hospitial on 6/3/2021 complaining of weakness and left sided chest pain occuring over several days.  She was tested for C19 via rapid test and found to be positive.  She was isolated and treated for C19 symptoms.  She has been  discharged to a Nursing Home setting.
Information has been received from a physician via a literature article, concerning a pregnant female who on an unknown date was vaccinated with a first dose of GARDASIL 0.5 ml, (lot#, application site and route were not reported) (Vaccine exposure during pregnancy). The Last Menstrual Period and Estimated Date of Delivery were unknown. The outcome of the event vaccine exposure during pregnancy was outcome pending. The investigator considered the event vaccine exposure during pregnancy to be not related to GARDASIL. Follow-up information was received in a published literature on 02-MAR-2015. Study participants, ethics, study design and vaccine composition have previously been reported. Briefly, this trial was initiated in January 2007 and data for the Month 60 analysis were collected up to May 2012. Women stratified by age (18-26, 27-35 and 36-45 y) were randomized (1:1 ratio) to receive 0.5 mL of HPV-16/18 vaccine or HPV 6/11/16/18 vaccine according to their recommended 3-dose regimens (Months 0, 1 and 6 or Months 0, 2 and 6, respectively). In order to maintain the blind, women received one dose of placebo (aluminum hydroxide) at either Month 1 or 2, as appropriate. The subjects, investigator, study personnel, and sponsor remained blinded until database freeze of the study. Of note, all data presented in this end-of study analysis have been unblinded. Thirty centers participated in the Month 60 follow-up. Anti-HPV-16 and -18 antibody levels were measured in all available blood samples. Methods for the PBNA and ELISA assays used in this investigation have been described elsewhere. Safety assessments in this end-of-study analysis were as described previously, including SAEs, NOCDs, NOADs, MSCs, and pregnancy outcomes. A total of 172 pregnancies were reported up to Month 60, with similar outcomes between vaccine groups. There were 71.9% (n = 69) and 73.7% (n = 56) live infants, respectively, in the HPV-16/18 and HPV-6/11/16/18 vaccine groups, with no unanticipated anomalies or outcomes. Fifteen (15.6%) and 11 cases (14.5%) of spontaneous abortion with no apparent congenital anomaly were reported in the HPV-16/18 and HPV-6/11/16/18 vaccine groups, respectively. This report referred to the three pregnant females. The patients were lost to follow up. This is one of the several reports received from the same source. Additional information is not expected. Literature information, study information, reporter, patient, product and narrative were updated.
As soon as I rolled out of bed at approximately 6:30 am, had extreme dizziness,  nausea and chills. Lasted until 1:45-2 pm.  Had aches and pains all day, fever of 100.3 for a short time in the afternoon.
pt recvd vax 5OCT92 & devel neurological s/s T11-T12 26OCT92; MRI's, LP lab etc; dx acute transverse myelitis w/profound neurological residue; deficit still present 10 months later;
Patient felt like she could not swallow , she was able to drink water without difficulty. We took the patients vitals at 12:35 pm heart rate 96, resp 20, o2 99, blood pressure 120/84, again at 12:45 pm heart rate 92, resp 20, o2 98 and blood pressure 123/73. Asked how the patient was feeling. The patient was feeling better  so we released her home with mom at 12:46 pm.
INFLAMMATION OF THE HEART REQUIRING ME TO GO ON 24HOUR NITROSTATE, AND PLAVAX. THE INFLAMMATION WAS TERMED ENDOCARDITIS BY EMERGENCY DOCTORS. I HAVE HAD TO GO TO THE EMERGENCY MULTIPLE TIMES. THE INFLAMMATION HAS MADE IT DIFFICULT TO PERFORM ALL ACTIVITIES OF DAILY LIVING.