chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Heart rate was extremely high; when I make any effort it goes high; This is a spontaneous report from a contactable consumer (patient). A 74-years-old male patient received BNT162B2 (Pfizer-Biontech Covid-19 Vaccine, Formulation: solution for injection, Batch/Lot Number unspecified, expiration date unspecified) via an unspecified route of administration on 16Mar2021 15:30 as DOSE 1, SINGLE for covid-19 immunization (74 year when vaccinated). Medical history included diabetes mellitus and hypertension from an unknown date. The patient's concomitant medications were not reported. On an unknown date in Mar2021, the patient reported I took a Covid 19, my first shot around 3:30 this afternoon and around 2:30 I woke up my heart rate was extremely high. When I did check it, it was like 101-102 and when I sit out for rest it got down to 78 or whatever, then I went back to bed. I just woke up around 6:15 and I went to the rest room and when I got to the rest room at very short distance my heart rate was extremely high and still, I am still resting now. I did not take anything, but it did get down to 88 but it is also like when I make any effort it goes high, walking over. On an unknown date in Mar2021, the patient had his heart rate checked and results were 101-103, 78 and 88 respectively. The outcome of the event was reported as unknown at the time of report.  No follow-up attempts are possible; information about lot/batch number cannot be obtained applicable.
Employee states w/in 45 minutes of vaccination she began to experience nausea, severe headache and felt like someone was sitting on her chest.
This spontaneous report as received from a pharmacist refers to a patient of unknown age or gender. No information was provided regarding the patient's pertinent medical history, concomitant medications, drug reactions or allergies. On 23-SEP-2017, the pharmacist was preparing to administer an unspecified influenza vaccine and ZOSTAVAX (exact dose was not specified; lot # N012492 with the expiration date of 17-MAR-2018) reconstituted with sterile diluent (lot # M047667 with the expiration date of 20-JUL-2019) to the patient. The pharmacist got distracted and inadvertently administered ZOSTAVAX intramuscularly (instead of the unspecified influenza vaccine). When he realized the error, the pharmacist immediately administered a second dose of ZOSTAVAX subcutaneously, as he thought that the dose administered intramuscularly would not be valid. No adverse effects were reported. Lot information apply to both doses of ZOSTAVAX and sterile diluent administered.
Information has been received from a physician and a practice manager via company representative referring to a patient of unknown age and gender. On 22-APR-2015 the patient was vaccinated with an improperly stored dose of PNEUMOVAX 23-10PK- 0.5mlSD-PFS LLokwTip) (lot # K019386, expiration date 09-JUN-2016). This specified lot number vaccine was exposed to temperature excursion four times.  The total cumulative excursion time of the first time was 80 hours with the lowest recorded temperature of 30 Fahrenheit degree. The total cumulative excursion time of the second time was 272 hours with the highest recorded temperature of 47 Fahrenheit degree. The total cumulative excursion time of the third time was 336 hours with the highest recorded temperature of 59 Fahrenheit degree. The total cumulative excursion time of the fourth time was 1172 with the lowest recorded temperature of -3 Celsius. The storage criteria and the type of excursion for this vaccine was refrigerator (R). No adverse effects were reported. This is one of several reports received from the same source. Additional information has been requested.
Pt got a 103.5 degrees fever 3 days after his vaccines, lasting 4 days, going down to 100 degrees and up to 102 and 103 day x 4 d. Then another fever turned up 7 days after vaccines 101.7 degrees lasting 2 days as well as a rash.
approx 30min p/vax pt exp rapid heart rate, feeling funny not right, throat feeling funny;pt sent to ER & released;
I had no regular symptoms, but a few days later I sat down in my chair and it felt like someone shot me in the stomach, I took oxycodone, it kept getting worse and I dealt with it for a week. I started getting pain in my kidney and went to the ER because of the pain and the pain level on a scale of 1-10 was a 8-9 at all times.  I couldn't' breathe and was rushed to the hospital. I have portal vein thrombosis and have three blood clots in my stomach.  I tried to figure out what to do to relieve the pain, I couldn't eat or during and was on IV's. I was in so much pain to even eat a cracker, they kept me at the hospital.  While in the hospital they did a CAT scan to see if it was diverticulitis and found out that I had 3 blood clots, they also did the dye or contrast. I spent days in the hospital and was transferred to the hospitals skilled nursing facility so that they can watch me because of the clots. I was told that the blood clots could burst in the vein.
Initial information received on 09-Oct-2018 regarding an unsolicited valid non-serious case received from a Nurse. This case involves a 29 years old patient who received vaccine TYPHIM VI (lot N1K121M, expiration date 10-Oct-2019) via intramuscular route in the left deltoid on 09-Oct-2018. The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided. It was a case of actual medication error due to Deteriorated drug administered and Product storage error. It was reported that vaccine was not good due to taking to long during shipping and we gave 2 doses. It was not reported if the patient experienced any adverse event. 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.
Severe headache, 104+ temperature, decreased level of consciousness, vomited 13 times, afternoon, evening at home & hospital, OTC could not reduce fever or stopped vomiting. Passed out 2x. One arm was swollen, red, painful, hot for 5 Days. At ER - Acute Febrile Illness & Viral Syndrome  Adverse Immune Reactions after Vaccinations  Continued ear infections  Difficulty w/weight gain/failure to thrive - gastro & nutritional support required  Pneumonia - 2x  Kidney Disease  Immune Compromised - In 2013 - Diagnosed w/ MTHFR Gene Mutation  Currently followed by Pulmonary, Nephrology, Allergist & Cardiological Specialists  Pediatric office did not respond to patient's request for records.
Flu like symptoms; Heat like rash across shoulder blades and upper back and down inside of right arm; Itching; Left arm to hand pain felt extreme pain; Shot site sore; Nauseous; This is a spontaneous report from a contactable consumer (patient). A 45-year-old non pregnant female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, lot number: EL8982 and expiration date was not reported) on Left arm on 20Jan2021 at 02:30 PM at single dose for covid-19 immunization. Medical history included fibromyalgia, ADHD, bipolar type 2, anxiety, IBS, acid reflux. The patient's concomitant medications include lamotriginel, amfetamine aspartate, amfetamine sulfate, dexamfetamine saccharate, dexamfetamine sulfate , omeprazole, clarithromycin, ascorbic acid. The patient was allergic to Loritab and Sulfa Meds. The patient did not receive any other vaccine within 4 weeks prior to the COVID vaccine. Reportedly, patient was not diagnosed with COVID-19 prior to vaccination. Patient had not been tested for COVID-19 since the vaccination. On 20Jan2021 at 03:00 PM, patient had shot site sore, nauseous. 25 min later left arm to hand pain felt extreme pain. Around 8pm itching and heat like rash across shoulder blades and upper back and down inside of right arm gone by morning. Next morning flu like symptoms until that Sunday. Patient took ibuprofen and Mucinex as a treatment medication. The outcome of the events was recovered.
red bumps and itchiness at the site of the second shot (right arm); red bumps and itchiness at the site of the second shot (right arm); This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 53 year-old female patient received bnt162b2 (BNT162B2), administered in arm right, administration date 31Mar2021 14:30 (Batch/Lot number: unknown) as dose 2, single for covid-19 immunisation. The patient's relevant medical history was not reported. There were no concomitant medications. Vaccination history included: Bnt162b2 (1st Dose, other vaccine same date vaccine , location: Left arm), administration date: 10Mar2021, when the patient was 53 years old, for Covid-19 immunisation. The following information was reported: VACCINATION SITE PRURITUS (non-serious), HYPERKERATOSIS (non-serious) all with onset 03Apr2021, outcome "unknown" and all described as "red bumps and itchiness at the site of the second shot (right arm)". Relevant laboratory tests and procedures are available in the appropriate section. Therapeutic measures were not taken as a result of vaccination site pruritus, hyperkeratosis.  Additional information: No treatment received, no covid prior to vaccination, covid tested post vaccination.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Headache, stomach pains, weakness and dizziness.  Loss of equilibrium on waking and getting out of bed.  Intermittent episodes of feeling like I want to pass out.
mild cases of measles/ red and inflamed, small dots over arms, legs, trunk, and back/ fever 102F; injection site was red and inflamed; injection site was red and inflamed; This spontaneous report was received from a registered nurse and refers to a 12-month-old female patient. Concomitant therapies included hepatitis a virus vaccine inactivated (HAVRIX) and influenza virus vaccine (unspecified) (INFLUENZA VIRUS VACCINE (UNSPECIFIED)) (reported as second dose baby flu). There was no information about the patient's concurrent conditions or medical history provided.  On 22-JAN-2020, the patient was vaccinated with measles, mumps, rubella and varicella (oka-merck) virus vaccine live (PROQUAD) lot # S013711, expiration date 01-NOV-2020, via subcutaneous route for 1 year wellness visit vaccines, reconstituted with sterile diluent (strength, exact dose, lot # and expiration date were not reported). On 31-JAN-2020, the patient experienced fever 102 degrees Fahrenheit (38.89 degree Celsius), small dots over arms, legs, trunk, and back, injection site redness and inflammation. The patient came in office on 02-JAN-2020, and as the treatment the patient received ibuprofen (MOTRIN), acetaminophen (TYLENOL) and diphenhydramine hydrochloride (BENADRYL). Complete blood count results was normal.  The reporter stated that this case was likely mild case of measles and would most likely not result in any samples being submitted to the Vaccine Program. Lot check was requested by the reporter.  The outcome of the events was unknown. The causality assessment between the events and suspect therapy was not provided. Additional information has been requested.  Upon internal review, the event of measles was considered to be medically significant.  This is one of several cases from the same reporter.; Sender's Comments:  US-009507513-2002USA001548: US-009507513-2002USA001507: US-009507513-2002USA001425: US-009507513-2002USA001134:
pt leg swelled to size of fifty cents piece on 1st day vax administered; 2nd day swelling greater than fifty cents piece;
ONE INCH SWELLING AROUND INJECTION SITE THEN AN ADDITIONAL 3 INCHES OF SWELLING ON TOP OF THAT WITH A LOW GRADE FEVER. SENT A PICTURE TO DR.
It started my cycle early. I did not report this sooner because I thought maybe I started my period early. But two weeks later I started as per my usual starting date.
This is a spontaneous report received from a contactable consumer or other non-HCP (patient). A 44-year-old female patient (not pregnant) received the 1st dose of BNT162B2 (Pfizer-BioNTech COVID-19 vaccine, batch/lot# FC3181), at the age of 44, in left arm, on Aug 11, 2021, at 13:30, single dose, for COVID-19 immunisation. The patient's medical history and concomitant medications not reported. The patient experienced a headache, onset Aug 12, 2021, at 13:30, with outcome of recovered (Aug 2021). Therapeutic measures were taken as a result of headache. Additional information: Prior to the vaccination, patient not diagnosed with COVID-19. Since the vaccination, patient not tested for COVID-19. The patient did not receive any other vaccines within four weeks prior to the vaccination. She took Tylenol for treatment. No follow-up attempts possible. No further information expected.
2/2/2021 Fatigue and itching right ear 2/3/2021 Feels like something crawling in Right ear. 2/4/2021 Intermittent right ear itch 2/5/2021 Slept 14 hours, "crawly "itch right ear, injection site raised and red with a knot at site. 2/6/2021  2/7/2021right ear and vaccine site itch 2/8/2021 Right ear is warm and itches, occasional ringing in ear bump on vaccine site. Feels like something is wiggling in both ears and at injection site. S 2/9/2021 Headache, right ear is warm and itches, ringing in ear occasionally. Bump at injection site. Skin peeling at injection site. 2/10/2021 Itch in ear and injection site.. red raised bumps at site. Still feels wiggly, ear warm. 2/11/2021 Arm is still sore , red and itchy. Raisedbumps at injection site. Ear feels crawly.  3/4/2021 right arm became ulcerated at the injection site and skin peeled. Small carter at site ans still itches. Tinnitus of right ear last 20 days.  3/26/2021 Second Vaccine given  3/29/2021 Muscle ache/pain, headache, fatigue, itching/rash at injection site, small blisters at site
Dizziness, took Meclizine 03/16/2021 around 3:30 pm
Prescribed oral Typhoid. Travelling. Took oral Typhoid. Reports having very severe abdominal cramps. "I think I had a case of Typhus." Hard to examine her patient at work. Came back 2/9/10 for polio SQ and reported the cramping. Follow-up information provided. Manufacturer  for vaccine number 2 and vaccine number 3: GlaxoSmithKline.
PATIENT DESCRIBES PAIN, A WELT ABOUT 2 INCHES BY 2 INCHES IN DIAMETER, PUFFING OUT, NO ITCHING HOWEVER.
Follow-up information received from the physician revealed results of an orthopaedic consultation on 12/15/03, including lab and diagnostic test results.  Information regarding Flumist (2003-2004 Formula) (influenza virus vaccine, live intranasal solution (frozen) was received from a nurse regarding an 11 year old male pt who experienced a fever of 104 deg F., left ankle pain, elevation of ESR (erythrocyte sedimentation rate), and elevation of CRP (C-Reactive Protein).  The pt received a dose on 12/12/03.  The pt was reported as "healthy".  Indication for Flumist (2003-2004 Formula) was immunization.  Product was administered on 12/12/03.  Dose regimen was 0.5mL (IN).  Concomitant medications were not reported.  On 12/14/03, 2 days post-immunization, the pt developed a fever of 104 deg. F. (pyrexia), and anteromedial lower left leg pain proximal to the ankle joint (arthralgia).  His fever was controlled with ibuprofen.  On 12/15/03, he was seen by an orthopaedic surgeon.  Abnormal lab values included an erythrocyte sedimentation rate of 21mm, and a C-reactive protein of 5 mg/dL.  Nuclear magnetic resonance imaging (MRI) of the left lower leg was normal.  On 12/18/03, the erythrocyte sedimentation rate was 35mm and on 12/19/03, the C-reactive protein was 6.18 mg/dL.  On 12/30/03, values of all labs drawn were within NL limits.  He was treated "symptomatically".  Continued observation and activity as tolerated was recommended.  As of 01/07/04, the child's symptoms had resolved completely.
Local reaction with swelling, followed by back pain, muscle aches, fever, no respiratory distress, numbness or tingling of lower extremities, no trauma
Patient had the Pfizer for her first series but did not tolerate it well. She decided to get the moderna for the booster series. The first booster she felt a bit fatigued. With the second booster she felt fatigued which progressed into leg weakness and heaviness, all over fatigue and malaise, shortness of breath and joint pain that lasted approximately one month. Slowly improved. 6/16/2022 was feeling back to her normal self.
After patient received the shot, she developed pain at the injection site an hour later. A couple of hours after that, her arm become extremely swollen which required her to go to the emergency department. It was determined that the patient was experiencing an adverse reaction to the vaccine.
Per client's Alert profile, first dose was Pfizer on 4/3/21 an second dose was Moderna on 5/1/21.  Alert says "series not valid" for the Moderna vaccine.
Pt rec'd vaccines at 11a.m. and returned to clinic at 1p.m. due seizure like activity as witnessed by mom.  Per mom pt began drooling, clenched jaw legs became rigid, pt was staring and unresponsive for about 4-5minutes; arrived at office with temp of 104.6 and marked irritability; was given dose of Ibuprofen and examined by MD- findings were normal neurological exam with no other sig abnormal findings besides fever and irritability.  Pt was monitored in office for approx 1 hour, then rtn'd for temp recheck at 4pm, fever had dec to 99.5 at that time after dose of Tylenol at 2:40pm.  It should also be noted that twin brother had almost identical symptoms.
Menstruation cycle was always regular lasting 5 days. After second vaccine dose menstruation cycle lasts 4 weeks, stops for one week and then starts up again.
Woke up about 2 am having tachycardia with heart rate from 123 bpm to 130 bpm that lasted about 20 minutes.  Developed urinary frequency and urinary incontinence through out the remaining night along with significant night sweats both on 4/19/22 and again on 4/20/22.   Had flu like symptoms, headache, nausea and just felt awful and miserable.  Also felt dis-orientated.
The patient was administered a dose that had been reconstituted and drawn up the previous night. It was beyond the 6 hour limit that is recommended by Pfizer. No adverse event was reported by the patient.
night sweats; cold feet; fatigue/tiredness; very brief sore throat; Slept poorly; Lots of a myalgias; arthralgias; Tendons were irritated of my lower extremity mobility was compromised; Tendons were irritated of my lower extremity mobility was compromised; This is a spontaneous report from a contactable physician. A 71-years-old male patient received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection) via intramuscular route , administered in Arm Left on 23Jan2021 08:30 (Batch/Lot Number: EL3246) as first dose, single dose (at the age of 71-years-old) for covid-19 immunisation . Medical history included plasma cell myeloma (Multiple myeloma), polycythemia vera, pneumonia (pneumonia five months earlier requiring hospitalization). Concomitant medications included bortezomib (VELCADE) ; lenalidomide (REVLIMID) ; prednisone ; aspirin [acetylsalicylic acid] (ASPIRIN [ACETYLSALICYLIC ACID]) ; levothyroxine sodium (SYNTHROID) ; febuxostat (ULORIC) ; gabapentin ; morphine sulfate (MS CONTIN) taken for an unspecified indication, start and stop date were not reported for all medications . The patient had no known allergies . The patient did not have covid prior vaccination and did not test for covid post vaccination. The patient did not take any other vaccine prior to four weeks. The patient also received second dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE) via intramuscular route, administered in Arm Left on an unspecified date (Batch/Lot Number: Ek9231) as second dose, SINGLE for covid-19 immunization .On 07Jan2021 09:00, On day three post vaccination fatigue for 48 hours than the development of a very brief sore throat but no temperature no hypoxemia no vital signs change out and then the development of night sweats but associated also with cold feet. Slept poorly. Lots of a myalgias some arthralgias. Tendons were irritated of my lower extremity mobility was compromised. Symptoms unfortunately occur still now 13 days later with resolution of some such as the night sweats, but the aches and pains fatigue tiredness all persist. The adverse event resulted in Doctor or other healthcare professional office/clinic visit. The patient did not receive any treatment. The outcome of the event night sweats was recovered on unknown date in 2021 and for rest all events was not recovered.  Follow-up attempts are completed. No further information is expected.
Starting 2 days after the vaccine, I started experiencing fever, cold-like symptoms, and a sore throat. I called my PCP and made an appointment with them. I ended up getting better on my own without any treatment after about 2 days.
Accidentally received the liquid portion of Menveo/ diluent only; Accidentally received the liquid portion of Menveo/ diluent only; This non-serious case was reported by a consumer via sales rep and described the occurrence of inappropriate dose of vaccine administered in a patient who received Men ACWY-CRM NVS (Menveo) for prophylaxis.   On an unknown date, the patient received Menveo. On an unknown date, an unknown time after receiving Menveo, the patient experienced inappropriate dose of vaccine administered (Verbatim: Accidentally received the liquid portion of Menveo/ diluent only) and inappropriate preparation of medication (Verbatim: Accidentally received the liquid portion of Menveo/ diluent only). The outcome of the inappropriate dose of vaccine administered and inappropriate preparation of medication were unknown.   Additional Information: GSK Receipt Date: 10-MAY-2023 The sales representative reported that a patient had accidentally received the liquid portion of Menveo.  After the agent was told that a healthcare professional had to reach out, they stated they would instruct the healthcare professional and ended the call.  The agent gave no information about them, the healthcare professional, the vaccine, patient or vaccination other than the fact that the liquid portion had been accidentally administered. The patient received the liquid portion of Menveo, which led to inappropriate preparation of medication and inappropriate dose of vaccine administered.
This spontaneous report was received from a female patient of unknown age referring herself. The patient concurrent conditions and medical history was not reported. On an unknown date in September 2014, the patient was vaccinated with ZOSTAVAX (dose and route were not reported). Concomitant medications were unknown. On an unknown date, the patient experienced a rash that comes and goes. The outcome of rash that comes and goes was reported as not recovered/not resolved. The relatedness of the rash with ZOSTAVAX was not reported. Additional information is not expected as the reporter details were not reported.