chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Tested positive for COVID 19 on 08Jul; Tested positive for COVID 19 on 08Jul; 1st dose-26Jun2021,2nd dose-26Jun2021; This is a spontaneous report from a contactable consumer (patient). A non-pregnant female patient of 44-year-old age received second dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Batch/Lot number was not reported), via an unspecified route of administration on 26Jun2021, as single dose for COVID-19 immunization. She received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Batch/Lot number was not reported), via an unspecified route of administration on 26Jun2021 for COVID-19 immunization. Vaccine was administered in Pharmacy or Drug store. Medical history included Polychondritis. Concomitant medication included Prednisone 10 mg then went to 5mg (received within 2 weeks of vaccination). Patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Prior to vaccination, patient was not diagnosed with COVID-19. She was vaccinated with two full doses of Pfizer, last does was on 26Jun2021. She tested positive for COVID 19 on 08Jul2021 while traveling abroad. Symptoms as of now are lots of congestion that seems to improve with Mucinex, no fever, no consistent cough. She Was not expecting this level of congestion with the vaccine since congestion seems to not be necessarily a main symptom. The patient underwent lab tests and procedures which included sars-cov-2 test on 07Jul2021 Nasal Swab, sars-cov-2 test: Positive. The events did not result in hospitalization. The outcome of Events was unknown.  Information about lot/batch number is requested.
Did not take fourth dose within 10 days; Spontaneous report received on 23DEC2019.  A pharmacist reported that the patient of unknown demographics who "did not take fourth dose within 10 days" (PT: Incomplete course of vaccination), while being on Vivotif for immunisation. The consumer took three doses of Vivotif according to schedule, but the fourth dose could not be taken within 10 days as twelve days had passed since the patient took the first dose. Action taken with Vivotif with respect to reported event was not applicable. The outcome of the reported event was unknown.  Company Comment: A consumer did not take fourth dose within 10 days of taking first dose of Vivotif (Incomplete course of vaccination). The causality of the event is assessed as not related to Vivotif due to the nature of the event.; Sender's Comments: A consumer did not take fourth dose within 10 days of taking first dose of Vivotif (Incomplete course of vaccination). The causality of the event is assessed as not related to Vivotif due to the nature of the event.
vaccine was kept in refrigerator on 29/10/2021 and administered/expired on 03/11/2021; 606 doses were given after expiration date; This spontaneous case was reported by a nurse and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (606 doses were given after expiration date) and PRODUCT STORAGE ERROR (vaccine was kept in refrigrator  on 29/10/2021 and administered/expired on 03/11/2021) in a 91-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 008C21A) for COVID-19 vaccination.     No Medical History information was reported.    On 03-Nov-2021, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 03-Nov-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (606 doses were given after expiration date). On an unknown date, the patient experienced PRODUCT STORAGE ERROR (vaccine was kept in refrigrator  on 29/10/2021 and administered/expired on 03/11/2021). At the time of the report, EXPIRED PRODUCT ADMINISTERED (606 doses were given after expiration date) and PRODUCT STORAGE ERROR (vaccine was kept in refrigrator  on 29/10/2021 and administered/expired on 03/11/2021) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant medications was provided by the reporter.  No treatment medications was provided by the reporter.  The vial was placed in the refrigerator on 29-Oct-2021.Vial did not undergo any temperature excursion. No adverse event was reported.
Following day I had pain in arm and a very bright red rash that formed on the injection site, injection redness site was large. Site was red, hot, painful and itchy. Redness lasted about 3-4 days.
After they took the bivalent six months or five months later they got covid again; After they took the bivalent six months or five months later they got covid again; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP), Program ID:.  A patient (no qualifiers provided) received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), as dose number unknown (booster), single (Batch/Lot number: unknown) for covid-19 immunisation; coviD-19 vaccine (COVID-19 VACCINE), as dose number unknown, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history included: "Suspected COVID-19" (unspecified if ongoing), notes: Had COVID-19 three times. The patient's concomitant medications were not reported. The following information was reported: DRUG INEFFECTIVE (medically significant), SUSPECTED COVID-19 (medically significant), outcome "unknown" and all described as "After they took the bivalent six months or five months later they got covid again".  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-PV202300063579 Same patient, same product, different event;
2 weeks after my second vaccination (final in the series at the time) I went into AFib (though didn't know what it was at the time). Was in AFib for over a month and it was not going away so I checked into the ER, where they immediately began treatment for AFib, and checked me into the hospital for what turned out to be a 4.5 day stay. Was on IV rhythm drugs and then oral, but not successful in getting out of AFib, so they performed a cardioversion which got heart back to normal rhythm. Was discharged from hospital and have been in medication for the last year and a half. I have had 4 recurrences of AFib in the past year, each lasting 1 to 2 days. I am scheduled to have an ablation procedure at the end of the month, in hopes of solving it permanently.  I do not know for certain that the vaccine brought on the permanent AFib of course...only to mention that it came on roughly 2 weeks (full immunization timing as I understand) after my second dose. I did get one booster later on that year and could not feel any adverse effects.  It is unknown if in had AFib episodes before the vaccination...possibly. There may have been an episode of AFib about a year before the vaccination year, as the symptoms felt similar, but it passed before and medical visit could catch it so we don't known for certain. Working theory was that perhaps the vaccinations exacerbated what was already an underlying hereditary heart condition but we can't know for sure. No other underlying heart of health conditions.
Patient presented to ED 8/29 with complaints of vomiting, and after visit continued with vomiting, diarrhea, and fever. Admitted 9/2 after brought back to ED with severe dehydration and electrolyte imbalances secondary to gastroenteritis. Received fluids and fluid boluses to correct, with initiation of TPN x 1 day since diarrhea output still large. Continues to try feeds, replace stool output with fluids, and work on feeding. At this time, patient has not been discharged but looks like she might be able to within the next few days.
Lower grade fever 6 hour after received 2 month old vaccine.  Fever 100.8---> 100.7.
,turned white and swollen at time of injection follwed by Rash All Over ,Pain ,Blitstering opening sores ,puss ,Dehydration,loss of consciousness,weight loss,face ,contact intching. And pain swelling on side of injections site.loss of appetite,Jaundice.loss of hair swelling at injection site. Eczematous condition,Extreme hospitalizations visits ,triamcinalone,hydrocortisone etc  High bilirubin Bililite
I was startled awake at a quarter to 2 in the morning by a ceramic plant pot falling and shattering.  My fiance and I jumped out of bed to investigate, following our dog to the site of the crash. When we saw what had awoken us, I pulled the dog back into the bedroom and closed the door. Suddenly, I felt nauseated then hot and cold at the same time. I sloppily ran to the bathroom thinking I was going to throw up and when I didn't, I stumbled back out, feeling disoriented. Luckily, my fiance knew something was up and checked on me right before I passed out. He's also an emergency medicine resident here in Queens so he knew what to look out for (even though he lamented the lack of medical tools in the apartment). He initially worried it was a stroke but my eyes twitching to the side and the recovery after a minute made him realize I had vertigo and it was vasovagal syncope that made me pass out.  After some juice, I eventually felt better and besides bad headaches and exhaustion Monday, I was fine.
Case number PHEH2016US026198, is an initial spontaneous report received from a healthcare professional on 10 Oct 2016. This report refers to a 05 years old male patient. Past medical history and concomitant medications were not reported. He was vaccinated with single dose of FLUCELVAX QUADRIVALENT (batch number: 185327) on 08 Oct 2016. On the same day after vaccination, the patient experienced redness, swelling and heat was observed from shoulder to close to elbow and around the 3/4 of the arm. The outcome of the events was reported as condition improving. The seriousness of the events was reported as non serious. The causality of the events was not reported.
received an expired dose of Rotarix; This case was reported by a other health professional via call center representative and described the occurrence of expired vaccine used in a 7-month-old female patient who received Rota (Rotarix lyophilized formulation) (batch number L5G93, expiry date 27th August 2021) for prophylaxis.   Co-suspect products included rotavirus vaccine oral applicator device (Rotarix Oral Applicator Device) oral applicator for prophylaxis.   On 29th October 2021, the patient received Rotarix lyophilized formulation and Rotarix Oral Applicator Device. On 29th October 2021, unknown after receiving Rotarix lyophilized formulation and Rotarix Oral Applicator Device, the patient experienced expired vaccine used. On an unknown date, the outcome of the expired vaccine used 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 details were reported as follows: The reporter was medical assistant. The patient received an expired dose of Rotarix that expired on 27th August 2021, which led to expired vaccine used. The patient had not developed any symptoms. The reporter consented to follow up.
Feels dizzy but thinks it may be anxiety.  No other signs or symptoms.  Informed to seek medical advice if any further problems.
I have tinnitus, and my tinnitus is noticeably louder than it has been for all the years I've had tinnitus, beginning after my second shot of the Pfizer Covid 19 vaccine. I cannot remember if this started the day of the shot (which I got on May 1, at around 2:20 PM), but definitely when I woke up the next morning I noticed that my tinnitus was louder. It is still louder today, May 6.
This is a spontaneous report from a contactable physician via Pfizer sales representative. This physician reported similar events for 3 patients. This is the 2nd of 3 reports. A patient of unspecified age and gender received first dose of TRUMENBA, at single dose and second dose of MENACTRA, both via an unspecified route of administration, on an unspecified date, for immunization. The patient medical history and concomitant medications were not reported. The patient experienced flu like symptoms on an unspecified date for 3 days with outcome of unknown. The information on the lot number has been requested. Sender's Comments: Linked Report(s): US-PFIZER INC-2019166742 Same reporter/products/events, different patients; US-PFIZER INC-2019170864 Same reporter/products/events, different patients.
Itchy red rash appeared at injection site 8 days after vaccine approximately 4? x 4?. Also realize I had an unusual mild headache the day before the rash. Unsure if it was related. My vaccine injection site seemed to cause more discomfort than others I have compared with, but totally resolved within a couple of days.
Had itching on legs that spread to face, chest arms and back. Then spread to abdomen also had hives and redness to chest.
Pt stated he felt like passing out, not feeling well. EMS assessed pt, diaphoretic, nausea, lightheaded. BP 130/74; P 61; Oxygen 97%; EKG NSR.  Pt managed by EMS, Dr Present. On stretcher and observed for 20 minutes. Symptoms resolved. Pt refused transport to ER
patient already received her 1st shot of moderna underaged at a different vaccination site. I was just honoring her 2nd dose since she was overdue for it. pt was fine no reaction. I got an ok from my district manager and patient care services manager to go ahead and honor her 2nd dose since she was due for it
Appointment note for reason of visit stated a second dose of vaccine was needed, I proceeded to administer the second dose of Pfizer Monovalent. When documenting, I noticed that the first dose administered was the Pfizer Bivalent instead of the Monovalent. I informed my supervisor and she said that she would reach out to the nurse clinic supervisor. The clinic director was also notified and will be calling the patient explaining the situation as well as provide a possible resolution.
Expired ACTHIB given to Patient with No reported Adverse Event; the risk for giving the vaccine twice to a 4-month old with no reported adverse event; ACTHIB given to a patient since the product itself expires of 28MAY2023 and the diluent expired on 30NOV2022 with no reported adverse event; Initial information received on 07-Dec-2022 regarding an unsolicited valid  non-serious case received from a Non health Care professional   This case involves a 4 months old male patient who experienced expired acthib given to patient with no reported adverse event, the risk for giving the vaccine twice to a 4-month old with no reported adverse event and acthib given to a patient since the product itself expires of 28may2023 and the diluent expired on 30-Nov2022 with no reported adverse event  after receiving vaccine HIB (PRP/T) VACCINE [ACT-HIB].  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.  Concomitant medications included diphtheria vaccine toxoid, hepatitis b vaccine rhbsag (yeast), pertussis vaccine acellular 3-component, polio vaccine inact 3v (vero), tetanus vaccine toxoid (pediarix) for immunisation; pneumococcal vaccine conj 13v (crm197) (prevnar 13) and rotavirus vaccine (rotavirus vaccine) for prophylactic vaccination  On 06-Dec-2022, the patient received a Series 1 of suspect HIB (PRP/T) VACCINE (Lot #Product: UJ679AA Diluent: U7178AA o Expiration Date: Product: 28MAY2023 Diluent: 30NOV2022 )(Dose-0.5mL) (Strength:standard)(Formulation: Powder and solvent for solution for injection) via intramuscular route on left leg for Immunization   On 06-Dec-2022 the patient developed a non-serious events expired acthib given to patient with no reported adverse event (expired product administered), the risk for giving the vaccine twice to a 4-month old with no reported adverse event (inappropriate schedule of product administration), acthib given to a patient since the product itself expires of 28may2023 and the diluent expired on 30-Nov2022 with no reported adverse event  (product preparation error) following the administration of HIB (PRP/T) VACCINE.(Latency- Same day)  It was reported She also wants to know the risk for giving the vaccine twice to a 4-month old.   Action taken : Not applicable.  At time of reporting, the outcome was Unknown for all events  This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holder's compliance with the requirements set out in the guidelines. 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.
Received vaccine on 7/31/7 - she has a 4cm swollen, red, indurated but not fluctuant mass in her rt. upper thigh - this correlates with DTaP. No drainage. She has been using her leg well but with discomfort. This appears to be a sterile abscess associated with the DTaP. Use warm compresses and antipyretics.
11/09/2021, 2 weeks post vaccine, My wife had a bad cough. I caught it from her. I went to the doctor he called in a prescription, He gave me Cal syrup and administered a steroid shot, and some type of "cillin" not penicillin, and I also took some steroid pills before I got the shot. And I still have the cough, mostly in the evening. He took x-rays and nothing showed up on that. I have been to the doctor twice and I am going to see him again. 12/13/2021- I still have the cough, but I do not know if it came from the shot.
Approximately 1 hour after receiving first dose of Pfizer COVID vaccine patient experienced persistent chest pain 3/10. Pain radiated from chest to back. She denied nausea/vomiting, shortness of breath, no dizziness, no rash, no itching, no swelling, no sensation of throat closing, Blood pressure at 2:30PM: 105/74, pulse 56.
Information has been received from a nurse concerning an "about 20 year old" female who on an unspecified date was vaccinated with third 0.5mL dose of GARDASIL (route and lot number not reported). The nurse reported that "about two months ago", in approximately February 2009, after receiving the third dose of GARDASIL the patient experienced really bad abdominal pain. The patient was taken to the emergency room, however it was unknown if the patient was admitted into hospital. Additional information has been requested.
Two weeks after the first shot, I noticed that I was fatigued and it is 8 weeks later and I still  feel fatigued.  I also lost my desire to have any type of alcohol, loss of appetite and for the same amount of time.  I noticed on May 21 that noises seem louder than normal.
Initial soreness of (L) arm. Disappeared after approx 48 hours. Approx 5-6 days after HPV experienced gradual onset increasing (L) shoulder pain radiating down (L) arm. When discomfort progressed to decreased ROM of shoulder on 10/12/07. Was seen by PP who prescribed Anaprox and Vicodin. States gradual improvement 30% since starting meds. PC on 10/17/07 states 100% improvement still taking Anaprox.
0800: malaise, just overall not feeling well, arm swelling at site, large knot.  12:00pm had to leave work due to 102 fever.  1500 arm swollen, lymph nodes in right arm pit swollen. And stayed swollen for several days after.  1800 fever still present  2000 fever finally broke.
This spontaneous report as received from a healthcare professional refers to 2 patients of unknown age and gender. Information regarding the patients' medical history, concurrent conditions or concomitant medication was not provided. On an unknown date, the patients were vaccinated with GARDASIL (dose, frequency, route and lot number not provided). Subsequently on an unknown date, the patients experienced syncope and recovered on their own on an unspecified date. Both of them were observed for 15 minutes after fainting and released. It was reported that neither of them sought for medical attention or required more interventions. Additional information has been requested.
Two days after a flu-shot on Oct. 2nd, I got headache, fever, sneezing and terribly fatigue, later on coughing which lasted for almost 10 days. The same symptomes repeated 3 times. The last one was just immiediately after the Thanksgiving and it lasted longer than the previous two with coughing and sputum till early this week (Dec 15th, 2008). I was happy to went through this terrible sickness. Unfortunately, I got headeche sneezing, fatigue and chilly again since this morning. These symptoms make me feel that the 4th cycle comes back to me again. I used to be a very heathy and seldomly sick person. This was the first time in my life that the terrible sickness made me lay in bed for so long repeatedly since I got the vaccine.
Patient reported itching, redness, swelling and tenderness. Patient was seen at an urgent care on for "Bad reaction to vaccine" and given BACTRIM. The patient reported that doct observed rash. Pt has been taking BENADRYL and applying cold compress.
Day 1 - Medium Circular Red knot at shot site/warm and painful.  Hard to raise my arm.   About 6 hrs after shot, I started to experience extreme fatigue and over the course of the next couple of hours malaise.   Day 2 - Shot site was larger.  Developed tender lymph nodes under arm and in groin.   More difficulty raising/moving arm.  Ibuprofen made  malaise symptoms more bearable. Day 3 - Shot site was a Larger circle -  3x3inches.  Still painful.  Started taking Alleve to alleviate symptoms.  My normal temp is around 97.6 .  At around 8pm it was at 99.0.   Continued to manage symptoms with Alleve.   Day 4 - Just starting day.  Woke up with upset stomach, but I was able to sleep on my right side even though the shot site is still sore and is slightly larger than day 3 (3.5x3inches)  It is also itchy at the moment.  It has not impacted my ability to go about my daily routine, but the severity and duration of the side effects were unexpected.
Within 30 seconds pain on my arm and it increased slightly. I was able to do my work. But every time I was stable and tried to use it again I felt pain again. Pain was always there - it was tolerable. I was told to take Ibuprofen about three hours later. Second day,  I could feel it but I didn't take medication. It slowly went away. No swelling, nothing. On January 4th started having symptoms nose bleeding; diarrhea; cold sweats; had a fever - but I didn't take it to know what it was. I very tired/ extremely sleepy; my eyes started feeling warm- these symptoms creeped up on me. It started around 10:00 am and within an hour an a half I had to tell my boss and they told me to leave work - but I couldn't drive. I stayed in my car and just slept and I was extremely tired. I had a coworker keep an eye on my because I looked really bad. I slept two or three hours in my car. I was still tired and I couldn't drive yet. So I stayed in my car a little longer until I felt stronger and drove home. I had started coughing and knocked out - but I was beginning to coughing a lot  on drive home- the  first hour I couldn't sleep because I was coughing so much - lasted an hour. Chest coldness for a couple of days - cold chest. It wasn't tight. Next day,  January 5, 2021 - went to doctor and they ordered COVID test. Dr thought I had a stomach virus. Diarrhea continued for two days. Weak and fatigue for 5 days. My Fever - temperature was on the first day was one day only. Second day, I did have a lot of fatigue and I was coughing a lot.  The fatigue lasted 10 days.
Moderately severe to severe itchy skin rash involving arms, legs, chest and back has persisted since May of 2021. Responds to systemic oral prednisone with topical prednisone (not to topical alone) and oral antihistamines. Currently on prednisone to prevent a flare. Lesions get red, irritated, vesicular lesions which leak, get crusty. Had biopsy, which reported showed spongiotic dermatitis. Further work-up ongoing.