chrisvoncsefalvay/vaers-outcomes huggingface dataset:
new diagnosis of a-fib received within 1 month of vaccine; This is a spontaneous report from a non-contactable consumer (patient). An 85-year-old non-pregnant female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Batch/Lot number was not reported), via an unspecified route of administration, administered in left arm on an unspecified date in Jul2021 (at the age of 85-year-old) at single dose for COVID-19 immunization at Doctor's office/urgent care. Medical history included Blood pressure high (HBP). The patient had no known allergies. The patient was not diagnosed with COVID prior to vaccination. The patient's concomitant medications were not reported. The patient experienced new diagnosis of a-fib received within 1 month of vaccine in Aug2021. The event was considered serious due to Hospitalization, Disability or permanent damage. The patient was hospitalized for the event for 5 days. The event resulted in Doctor or other healthcare professional office/clinic visit, Emergency room/department or urgent care. Therapeutic measures were taken as a result of the event which included Eliquis and amiodarone. The patient had not been tested for COVID post vaccination. The event outcome was not recovered.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
High fever to 102 with uncontrollable shivering and chills beginning apx 12 hours after injection, improved with ibuprofen but not resolved, fever continued x 16 hours
pt exp an asthma attack 24 hrs p/DTAP immun; pt did not have a local react; No adverse event following prior DTP vax;
Information has been received from a health professional concerning a 43 month old male who on 07/29/99 was vaccinated with the first dose of Varivax SC in the right arm. On 12/10.01, the patient developed individual red lesions. On 12/11/01, the patient's mother telephoned the physician's office and noted that there was a white center developing on the lesions. It was also noted that the lesions were spreading with 5 more on the torso since the day before. A fever was also noted. It was reported that this information was received from the patient's  mother who reported "a very mild case" which was not verified by a doctor . No additional information is available.
Patient called our pharmacy and stated she had a ?heart attack? after she received her first COVID 19 vaccination. She stated she was otherwise healthy before the vaccination and a subsequent heart cath showed no blockages.  Her cardiologist recommended to report this incident and for her receive her second COVID-19 vaccine.
Initial unsolicited valid non-serious report received from a Pharmacist on 02-Oct-2018. This case involves a 15-years-old (unknown gender) patient who was vaccinated with a dose of FLUBLOK QIV (Batch number, expiration date, dose, route and site of administration was not reported) on an unknown date. The patients medical history and concomitant medications were not reported. It was an actual medication error due to inappropriate age at vaccine administration (15 year old patient received the FLUBLOK QUADRIVALENT vaccine). It was unknown whether patient experienced any adverse event following vaccination. This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holders compliance with the requirements set out in Directive 2001/83/EC and Module VI of the Good Pharmacovigilance Practices. The classification as a medical error is in no way intended, nor should it be interpreted or construed as an allegation or claim made by the marketing authorization holder that any third party has contributed to or is to be held liable for the occurrence of this medication error. List of documents held by sender: none. Follow up report received on 18-Dec-2018 from a Pharmacist. No new information received. List of documents held by sender: none.
In hindsight, developed a variety of symptoms in late May that continued until medical treatment was sought in July.  This included a general feeling of being unwell,  raising heart, lightheadedness,  easily tired,  weakness in lower body,  weight loss, increase in bowel frequency, heat intolerance,  trouble sleeping, anxious/nervous,  irritability.
Systemic: Dizziness / Lightheadness-Medium, Systemic: Fainting / Unresponsive-Medium, Systemic: Nausea-Mild, Systemic: Vomiting-Mild, Additional Details: Pt previously had episodes of fainting after getting blood drawn in the past
Syringe defective, incomplete dose given (0.1 mL). patient was re-vaccinated in the opposite arm
Adverse reactions include dizziness, nausea, stuffy head, aches, and fever, which has continued for 7 days now.
Patient was given Pfizer vaccine by accident. Patient registered multiple places for vaccines and received his first dose of Moderna on 3/17/21 and since he never cancelled his "other" appointments he was given a reminder to go for his 2nd Pfizer. Patient did not inform the pharmacist until after the fact.
Vasculitis of nose for about 30 minutes.  No pain nor discharge.  Minor tingling.  No longterm side affect
Diffuse urticaria.  Given Axid, Zyrtec & Depomedrol.  2 days later recurred.  Received 2nd dose Depomedrol.
pt recv vax & 17 days post vax pt presented w/hep A & was hospitalized for tx;pt did not recv immunoglobulin;reporter stated that this case represents an exposure to hep A a/vax rather than a failure of therapy;sx cont;
pt recv vax & w/in approx 1 & 1/2hr p/vax pt did not feel well & exp diff breathing & a rash;
Vaccines given 6/28/2007. Mother brought patient to office 6/29/07 stating child was cranky, didn't sleep most of the night and developed a rash mostly on the trunk. She stated she noticed a rash this morning. Patient was seen by doctor given a prescription for Benadryl, Appt for follow up on 7/2/07.
Fever of 101 night of immunization, which subsided by next morning.  For the 2 days following vaccination, he complained of severe headache, nausea, with episodes of vomiting, dizziness with unsteady gait. On the 3rd day following vaccination, he was taken to Urgent Care and transferred to hospital with resulting Dax of Cerebellar CVA.   The cause was not determined during hospitalization, though a narrowed artery of the cerebrum was noted on MRI
I was sitting quietly looking waiting for the observation time to finish and started feeling that my heart was racing, felt like it was over 130 but hard to count.  Had some water, moved closer to the staff that were administering doses and told them I felt weird and my heart rate was fast but feeling ok.  Would let them know if it got any worse.   I started to think I was having either a reaction or worrying about the side effects, etc. and willed myself to calm down.  It felt like an adrenaline rush and did not last longer than a few minutes.  I didn't report it  to VAERS at the time thinking it was "just in my head".   Thankfully it went away and I did not need any treatment.  Just felt a little shaky and glad that it went away. Only other side effect that I had was a sore arm for a couple days.  Looking at the CDC website since then, I am not sure if I should get the second dose and would like advice on this.
Tiredness, headache, swelling at injection site, muscle pain, chills, joint pain and a fever of 101.0
I woke up in the middle of the night feeling very dizzy, even when I simply rolled over in bed. It took almost an hour to get the symptoms under control, and even then, I still felt dizzy while dying down for another 4 hours or so. The dizziness was almost to the point of making me fall unconscious, and I felt very warm the entire time. The dizziness was followed by very severe shaking.
area where got vax was red & maybe bruised looking; moved leg OK; went to sleep 945 & woke up 3AM for a feeding; woke up 515AM, back to sleep 6AM; 745AM up & ate breakfast; 830AM pt put to bed; checked 1130-1145 hands were cold; CPR done;
17 yo with progressive scleroderma with chronic pain and depression and recent admission to clinic brought in by father for concerns for vaccine reaction to PPV-23 Received vaccine 11/7/19 at 10am and at 4pm started having significant pain in arm and by 8pm had so much pain she was unable to move arm. She developed body aches all over and is still tender this morning over her shoulder on 11/8/19 also pain in her back and arm. She also had dizziness, and had a hard time sleeping and hard time getting out of bed due to severity of symptoms. Ibuprofen helped a little. Today 11/8/19 is a bit improved but still not moving arm because she has significant pain. Able to use hand normally, no tingling or numbness. Had significant pain with previous vaccines but no systemic reaction such as this.
p/vax lt arm where vax given is very sore, red rash, fever & itched;
anaphylactic reaction; Almost as he had croup; This spontaneous report was received from an unspecified reporter via Pfizer and refers to a 4 year old male patient. The patient's concurrent conditions, medical history and concomitant therapies were not provided.   In 2010, the patient was vaccinated with measles, mumps, and rubella (wistar ra 27-3) virus vaccine, live(manufacturer unknown) (dose, vaccination site, route and lot# were not provided), for prophylaxis.    In 2010, the patient had a anaphylactic reaction to the MMR (measles, mumps, and rubella) vaccine. This reaction caused him to wound up in the emergency room 5 hours after having the vaccine, he received Epipen and breathing treatments as his throat was closing in and he had chest sounds, aImost as he had croup.  At the time of reporting, the outcome of anaphylactic reaction and croup infectious was unknown. The reporter considered anaphylactic reaction to be related to Measles, Mumps, and Rubella (Wistar RA 27-3) Virus Vaccine, Live(manufacturer unknown) but the reporter did not provided a causality assessment between croup and Measles, Mumps, and Rubella (Wistar RA 27-3) Virus Vaccine, Live(manufacturer unknown).  Upon internal review, croup and anaphylactic reaction were determined to be medically significant.
A report was received from a health professional on 05 Nov 2001, concerning a 62-year-old female patient who experienced swollen and tender lymph nodes, 1 day after receiving the Fluvirin vaccine on 02 Nov 2001.  On 03 Nov 2001, the patient ( a registered nurse and an infection control practitioner ) experienced swollen lymph nodes and tenderness under the right arm that spread to the right chest area, 1 day after receiving the Fluvirin vaccine in the right deltoid muscle.  The patient experienced a similar reaction 2 years previously, following an Influenza vaccination (brand unknown).  At time of report, the patient had not recovered.  There was insufficient informaton to determine the reporter's causality assessment.
Information has been received from a medical assistant concerning a 65 year old male patient with diabetes. hypertension and hyperlipidaemia and with no drug reactions/allergies who on 01-MAY-2012, was vaccinated IM with 0.5 ml dose of PNEUMOVAX 23 (lot number 672962/0025AE, expiration date: 18-OCT-2012). On approximately 01-MAY-2012, 5 hours after vaccination, the patient developed a localized reaction after receiving PNEUMOVAX 23. It was also reported that the patient developed severe, almost paralyzing pain of his arm. The patient called the office. The patient was treated with TYLENOL and ice to be placed on the patient's arm. No lab diagnostic studies were performed. At the time of the report the patient was recovering. Follow-up information has been received from the medical assistant concerning a 65 year old male who on 01-MAY-2012, 14:30 was vaccinated with a dose of PNEUMOVAX 23, I.M. on right deltoid. On 01-MAY-2012, 17:30, the patient developed pain radiating from shoulder down arm and into hand. No numbness or tingling. Unable to left arm without severe pain. Patient recovered on 03-MAY-2012. Additional information is not expected.
This spontaneous report was received from a certified medical assistant and refers to a 11 year old female patient. Information on the patient's concurrent conditions, medical history or concomitant medications was not reported. On 28-APR-2016 at 10:26, the patient was vaccinated with GARDASIL 9 (lot # M004116, expiration date: 12-OCT-2017) dose 1, intramuscularly in the left arm. On unspecified date, the vaccine that was administered to the patient has been improperly stored by being exposed to temperature: 34F for a total time of 65 hours. There were no previous temperature excursions. No adverse event, signs or symptoms were reported. The patient had no illnesses at time of vaccination. This is one of the several reports received from the same source. Additional information is not expected as all available information was obtained.
Developed fever (101.5), fatigue, headache, and dyspnea on exertion within a day of vaccination and symptoms continued until admission to hospital 4 days later
Patient came in to receive her first dose of the Pfizer COVID-19 vaccine on 01/05/2021. While the needle was in her arm and the nurse was applying pressure to the syringe the vaccine started to leak out of Pt's arm. Patient was worried that she did not receive her entire first dose of the vaccine. It was reported to the Pharmacy and to, Director of Nursing. It was determined that Pt should receive a second first dose on 1/13/2021.
pt recvd MMR vax 1MAR91 & on 9MAR91 exp malaise, h/a, fever, chills; next day devel lymphadenopathy & presented to MD; lab eval revealed elevated WBC count; on 13MAR91 c/o joint pain; 20MAR91 sx subsided; exp inc fatigue;
Angina  Chest pain radiated down arm and shoulder blade for one evening and 2 full days  Narrative:
left side of face drooping, given prednisone 10mg take 6 tabs qd for 5 days, then 5 tabs,x's 2 days, 4 tabs qd x's 2 days,3 tabs qd x's 2 days,2 tabs qd x's 2 days then 1 tab qd x's 2 days
This spontaneous report as received from a physician refers to a 15 week old infant patient of unknown gender. The patient received two doses of ROTATEQ within one week: one on 10-DEC-2013 and another on 16-DEC-2013. The outcome of infant received two doses of ROTATEQ within 1 week was unknown. Additional information has been requested.
After vaccination I felt diaphoretic and dizzy. After waiting in the monitoring area for 45 minutes I drank some water and felt like my bilateral upper thighs were difficult to lift when I tried to walk to my car. I went home and was tachycardic 120-130bpm that continued throughout the night to the point I couldn't sleep my heart was pounding so hard and fast. I was extremely thirsty and dehydrated all night.  I continued to have tachycardia for several days despite hydrating. My thighs also continued to feel week for several weeks. I developed a 100.7 F temperature and had flu like symptoms the following days.
11/25/22 presents for "worsening SOB". PMHx of "CHF (EF 35-40%), moderate AS, DM-2, OSA, Prostate and bladder CA"
15 minutes after vaccine received, patient reports feeling hot in face and then all over body about 1 minute later. Patient reports left sided headache. Patient denies respiratory distress. Patient advised to follow up with primary care provider and to call 911 if symptoms persist or experience respiratory distress. Patient instructed to take Acetaminophen/Ibuprofen, to have food/fluid, and to rest. Pt able to hydrate with water. Patient ambulatory and reports symptoms resolved after 45 minutes. Patient reports able to return to work. Patient declined transportation to hospital for further evaluation. BP132/84, HR 72.
wife's report "He said he was nauseated all night.  at 5am this morning (3/10)  he was vomiting and said his stomach felt bloated like it 'needed to pop'.  He had a 100.8 temp this am, back pain.  he took tylenol at 12:30p and now his temp is at 100."
20 m after lightheaded. Then 2 hrs later itchy eyes and swollen. Relieved by BENADRYL. Sore (L) side of neck.
This spontaneous report as received from a nurse refers to an unspecified number of patients of unknown age and gender. On an unknown date in 2014 (reported as since 08-AUG-2014), the patients were vaccinated with VARIVAX (Merck) which was improperly stored, (strength, dose, lot numbers and route were not reported). No adverse effects were reported. Follow up information has been received from the registered nurse who stated that it will take some time to get the VARIVAX (Merck) information (patient identifiers, lot numbers, expiration dates and dates of vaccine administration) together and that she may send the information at a later time. Follow up information has been received from the registered nurse concerning a patient (age range reported as 13-18, units not reported) of unknown gender. On 06-OCT-2014, the patient was vaccinated with a dose of VARIVAX (Merck) which was improperly stored (lot number K005180, expiration date 10-APR-2016; dose number, dose and route were not reported). The reproter stated that this was the information that they could find and provide and anything further would be much too difficult and time consuming due to their record keeping and tracking system. This is one of several reports received from the same reporter. Additional information is not expected because follow up has been obtained.
I did not have an adverse reaction to the vaccine. I started feeling symptoms on 06/28/2022 with mainly coughing.  I tested positive for COVID-19 on 06/29/2022 with a home test.  As I was traveling during this time I had a video conference with medical staff at a urgent care center in another location.  I was given the prescription Paxlovid and started feeling better within 24 hours.
DEATH; HAD A STROKE; SAME PROBLEM; This spontaneous report received from a consumer via a company representative via social media concerned a patient of unspecified age, sex, race and ethnic origin. The patient's height, and weight were not reported. No past medical history or concurrent conditions were reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of administration was not reported, batch number: Unknown and expiry: Unknown) dose, start therapy date were not reported, 01 total administered for prophylactic vaccination. The batch number was not reported. Per procedure, no follow-up will be requested for this case. No concomitant medications were reported.  On an unspecified date, consumer posted " my friend had same problem after shot and then had a stroke and died. Doctors just said health great including heart ". On an unspecified date, the patient died from unknown cause of death. It was unknown if an autopsy was performed. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of same problem and had a stroke was not reported. This report was serious (Death, and Other Medically Important Condition).  Version created to amend previously reported information on 11-FEB-2022. Upon review the following information was amended: Amendment Adverse Event (The case validity assessment was updated to valid from the previously incorrect assessment of non-valid).; Sender's Comments: V1: Version created to amend case validity assessment to valid from the previously incorrect assessment of non-valid. This does not alter previous causality assessment of the reported events. 20220230403-covid-19 vaccine ad26.cov2.s -Death, Had a stroke. The event(s) has a compatible/suggestive temporal relationship, is unlabeled, and has unknown scientific plausibility. There is no information on any other factors potentially associated with the event(s). Therefore, this event(s) is considered unassessable.; Reported Cause(s) of Death: UNKNOWN CAUSE OF DEATH
BACK OF ARM PAINFUL WHICH WAS FOLLOWED THE NEXT DAY BY SYMPTOMS OF REDNESS AND HOT.  NO ICE OR MEDICATION WAS UTILIZED TO TREAT THE SIDE EFFECTS.
Fever of up to 100.4, chills, all over muscle pain, arrhythmia, and headache. At one point I felt like I was on fire. Those symptoms began around 8 hours after injection. All of the above symptoms resolved by 8:00 the following evening. I currently have swelling, itching, redness, and rash near injection site. These symptoms began around 5 hours after injection. Area is warm to the touch. The area of redness and swelling has grown larger over the past 6 days. It is about 6 inches across and 4 inches in length. Following My first dose a month prior, I did get the redness the swelling and the itching  immediately following the injection. That all cleared up about 4 days later, and returned again 11 days after the injection. The swelling and redness were not as large as they currently are, after the first injection. I had no chills, fever, muscle pain, arrhythmia, or headache following my first dose of the vaccination.
Initial misuse report received from a healthcare professional on 30-Aug-2013. A 02-months-old patient had received both PENTACEL and PEDIARIX were administered at the same time. No adverse event was reported. List of documents held by sender: none.
Rib fracture; Coughing; Pneumonia; This is a Solicited report based on the information received by Pfizer from a company (MFR Control No: 21K-163-4052550-00). A contactable consumer for herself. A 60-year-old female patient received bnt162b2 (BNT162B2) intramuscular on an unspecified date (Batch/Lot number was not reported) as single dose for COVID-19 immunisation; adalimumab (HUMIRA) subcutaneous from an unspecified date (Batch/Lot number was not reported) at unspecified dose for moderate to severe rheumatoid arthritis. The patient medical history included COVID-19 in Oct2020. Concomitant medications were not reported. The patient experienced pneumonia in May2021, rib fracture on an unspecified date, coughing on an unspecified date. The action taken in response to the events for adalimumab was unknown. The outcome of events was not recovered.    The reporter's assessment of the causal relationship of the events with the suspect product was not provided at the time of this report. Since no determination has been received, the case is managed based on the company causality assessment.  No follow-up attempts are possible, information about batch number cannot be obtained. No further information expected.; Sender's Comments: Based on available information, it appears unlikely that vaccine BNT162B2 contributed to the reported events Pneumonia, rib fracture and cough.However, current information is limited and does not allow a full medical assessment.