chrisvoncsefalvay/vaers-outcomes huggingface dataset:
nausea; This is a spontaneous report from a contactable consumer (patient). A 97-year-old female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; lot number and expiry date: unknown), via an unspecified route of administration on the left arm, 07Jan2021 at a single dose for COVID-19 immunization  Medical history included cardiac failure congestive. The patient's concomitant medications were not reported. Patient was not pregnant at time of vaccination. The patient previously took quinine and experienced allergy. The patient experienced nausea starting approximately 1 week after shot on 15Jan2021 and continuing for 5 days. Outcome of the event was recovering. No treatment was received. The event was considered non-serious. Patient was not diagnosed with COVID-19 prior to vaccination.  Information on the lot/batch number has been requested.
After administration, the patient sat in a chair for observation.  2-3 minutes after administration patient had a loss of consciousness, falling out of his chair onto the carpeted floor.  Patient observed having seizure-like contractions of his upper extremities and slight arching of his back while having this loss of consciousness.  LOC lasted less than 10 seconds.  Patient was placed on his side, and when he regained consciousness could answer all questions appropriately and without delay.  Patient was placed in a wheel chair and taken to a private observation area where vital signs could be attained.  Patient again had a LOC while being wheeled in the wheel chair to the private observation area.  Patient was placed on a gurney, supine.  Vital signs taken and patient was found to have a heart rate in the 40s and a blood pressure of 90/66.  Patient was ashen and diaphoretic.  Patient was observed for 30 minutes in the private observation area where his condition improved to normal before leaving the facility.
large red circle at injection site with edema/hematoma/pain; large red circle at injection site with edema/hematoma/pain; large red circle at injection site with edema/hematoma/pain; large red circle at injection site with edema/hematoma/pain; Muscle aches/generalized; fever; itching over whole body; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 36-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 22Apr2022 at 12:00 as dose 1, single (Lot number: fk9895) at the age of 36 years, in left arm for covid-19 immunisation. The patient's relevant medical history included: "ADD" (unspecified if ongoing); "covid" (unspecified if ongoing), notes: if covid prior vaccination: Yes. There were no concomitant medications. Past drug history included: Known allergies: iodine, reaction(s): "Known allergies: iodine". The following information was reported: MYALGIA (non-serious) with onset 22Apr2022 at 22:00, outcome "not recovered", described as "Muscle aches/generalized"; PYREXIA (non-serious) with onset 22Apr2022 at 22:00, outcome "not recovered", described as "fever"; PRURITUS (non-serious) with onset 22Apr2022 at 22:00, outcome "not recovered", described as "itching over whole body"; VACCINATION SITE ERYTHEMA (non-serious), VACCINATION SITE OEDEMA (non-serious), VACCINATION SITE HAEMATOMA (non-serious), VACCINATION SITE PAIN (non-serious) all with onset 22Apr2022 at 22:00, outcome "not recovered" and all described as "large red circle at injection site with edema/hematoma/pain". The events "large red circle at injection site with edema/hematoma/pain", "muscle aches/generalized", "fever" and "itching over whole body" required physician office visit. Therapeutic measures were taken as a result of vaccination site erythema, vaccination site oedema, vaccination site haematoma, vaccination site pain, myalgia, pyrexia, pruritus.
19 y/o male reported back to site after leaving post 15 minute wait period.  Pt had redness/rash on L lower arm. Pt had received vaccine at 08:39 in the L deltoid.  Pt returned to site at 09:00 with above symptom.  Pt states itching as well as slight tightness of the neck with NO difficulty breathing.  Pt states felt like a tight short collar.  Pt vitals taken and were stable.  Rash had progressed up the L arm by time of EMS arrival.  EPI was not given in clinic due to no complaint of shortness of breath.  Pt care given to EMS crew.
chest pain; This is a spontaneous report received from a non-contactable reporter(s) (Consumer or other non HCP) from medical information team, Program ID. The reporter is the patient.  A female patient received BNT162b2 (BNT162B2), in 2020 as dose 1, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history included: "Psoriasis" (unspecified if ongoing). Concomitant medication(s) included: COSENTYX taken for psoriasis. The following information was reported: CHEST PAIN (non-serious) with onset 2020, outcome "unknown".  Additional information: Patient reported chest pain once after first dose. She was taking Cosentyx monthly and asked the effectiveness of the Pfizer-BioNTech COVID-19 Vaccine. She Stated that she was forced to get a COVID shot where she was a housekeeper. Seriousness reported as No.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Pt recv vax on 9/15/98; on same day pt exp fever (104F), nausea &vomiting for 2 day.
ADMITTED TO ICU WITH SEPTIC SHOCK, FOUND TO BE COVID POSITIVE. DEVELOPED HYPOXEMIA, LOWER ABDOMEN PAIN, WEAKNESS, VERTIGO, N/V, REQUIRED 3 LITERS O2 TO MAINTAIN O2 ABOVE 90%.  FOUND TO HAVE DIVERTICULITIS, DUODENITIS.  THEN DEVELOPED CARDIOVASCULAR SEPTIC SHOCK AND PATIENT EXPIRED
Shortness of breath, nausea, disequilibrium. Diagnosed in intensive care at Hospital with complete heart block bradycardia (approx 30 beats a minute). MRI showed no inflammation. No faults found with catheter investigation via groin. After 10 days in intensive care I was moved to different hospital for a pacemaker. Sensation of disabling disequilibrium has not ceased. Ear doctor found no problem with inner ear. Brain scan tomorrow.
pain on both arms; upset stomach; leg cramps; This is a spontaneous report from a contactable consumer or other non hcp Pfizer-sponsored program.  A female patient of an unspecified age received bnt162b2 (Pfizer Covid-19 Vaccine, Solution for injection, Lot No was not reported), via an unspecified route of administration on 12Feb2021 as 1stdose, single for covid-19 immunisation. The patient medical history was not reported, and concomitant medications were not reported.  The patient experienced pain on both arms, upset stomach, leg cramps on Feb2021. Patient is asking if our vaccine is FDA approved. Outcome of the event was unknown. Upon follow-up 12May2021 it was stated that follow-up attempts completed. No further information expected Follow-up (12May2021): Follow-up attempts completed. No further information expected.
Woke up the next morning with red raised rash (felt like sand paper). C/o headache and felt fevery (Did not take temperature Rash covered body abdomen, back arms legs face. Rash has faded but on 07/29/2011 can still feel the sand paper rash.
soreness at injection site; Splitting headache for 48 hours after injection; nausea; body aches; fatigue; This is a spontaneous report from non-contactable consumer (patient). An adult male patient of an unspecified age received the second dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number and expiration date unknown), via an unspecified route of administration on 30Jan2021 at a single dose for COVID-19 immunisation. Medical history included asthma. The patient previously took the first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, lot unknown and expiration date unknown) on 09Jan2021 for COVID-19 immunisation. The patient's concomitant medications were not reported. It was not known if the patient received other vaccines within 4 weeks prior to the COVID vaccine. It was not known if the patient was diagnosed with COVID-19 prior to vaccination. The patient experienced splitting headache for 48 hours after injection, nausea, body aches, fatigue and soreness at injection site all on 30Jan2021. The patient recovered from splitting headache on 01Feb2021 while the patient recovered from the other events on an unspecified date.  No follow-up attempts are possible; information about lot/batch number cannot be obtained.
Felt chest pain going down arm and leg. felt if stood up to fast may have stroke or Heart attack.  Went to ER pain got a little better.  Took vitals, gave CAT scan, Dr said developed blood clot.
I had a bad headache and was starting to get sinus congestion and a cough. I was feeling a little feverish. I took an at home COVID-19 test and it tested positive. After that, I was able to get the telehealth appointment around 08:40 that morning. After going through the meeting with the PA, she prescribed Paxlovid for me. I started to take the Paxlovid that day around 10:00AM and took the 5 day regimen every 12 hours. After the end of the first dose before the 2nd dose, the symptoms had subsided. For the 5 days of Paxlovid, I felt a little brain fog and had a metallic taste in my mouth. I didn't feel too bad, just lousy. I quarantined by myself for 5 days. Other than those 2 symptoms from the Paxlovid, I was fine. On the 5th day, I did test again and came back negative and I've been negative since. It was a pretty mild encounter with COVID-19. Took a couple weeks to feel fully myself again between the infection and the strong medication.
8-24 hours post-injection: fever (100.5), chills, headache, tiredness, mild pain at injection site 24-36 hours post-injection: tiredness 4.5 days post-injection: headache, vomiting
7-10 minutes after vaccine he fell out of chair + was clinching his arms according to his mother He stated that he was impacted  but came back - he was breathing the entire time - no difficulty breathing - then in 10 minutes hes dyspnea called 911 Paramedics came + treated 90/66 - 66 - sinus Per paramedics 1548
Treatment of COVID-19; Treatment of COVID-19; This is a spontaneous report received from a non-contactable reporter(s) (Other HCP).  A 48-year-old male patient received BNT162b2 (BNT162B2), as dose 3 (booster), single (Batch/Lot number: unknown) for covid-19 immunisation; coviD-19 vaccine (COVID-19 VACCINE), as dose 1, single (Batch/Lot number: unknown) and as dose 2, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant) all with onset 08Jul2022 at 13:00, outcome "not recovered" and all described as "Treatment of COVID-19". Therapeutic measures were taken as a result of drug ineffective, covid-19. COVID rebound after Paxlovid treatment, from 26Jun2022 to 01Jul2022.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.; Sender's Comments: The efficacy of a drug varies from patient to patient and can be affected by different factors, however a contributory role of the suspect drug BNT162B2 (COMIRNATY) to the reported events Drug ineffective and COVID-19 cannot be ruled out.
Patient had received 3 prior DTaP shots, but was not caught up on them at 2 years, so a DTaP shot was given 3 days after DTaP shot, leg was greatly swollen, about twice the size of normal thigh.  Was not hard, but still fleshy feeling and did not have fever.  More noteworthy, 10 days afer shot, he started limping in the opposite leg that shot was administered.  14 days after he is still limping, intermittenly, but has gotten worse.  Xrays came out normal.  Are still proceeding with diagnosis.
This case was reported by a nurse and described the occurrence of fever in a 4 year old male who received diphtheria and tetanus toxoids and acellular pertussis vaccine absorbed for prophylaxis. On 9/12/03, the patient received an injection of Infanrix. On 9/15/03, three days post immunization, the patient's parent telephoned the physician to report that the patient was experiencing fever, malaise and an injection site reaction characterized by redness, swelling and induration. The events resolved on an unspecified date prior to 9/17/03.
Received PPSV23. The next day pt. reported that he woke up in the morning with redness and tightness. Erythema noted at injection site spreading to under arm. Pt. had difficulty raising arm greater than shoulder height. BENADRYL 50 mg and warm compresses were recommended by MD.
Patient is a 15-year old male, should have received Pfizer instead of Moderna.
Felt lightheaded after leaving the immunization room and sitting out front. She put her head between her knees. Technician saw that she wasn't feeling well and we went out to check on her. I asked her to sit on the floor incase she fainted. She laid down. If she was not conscious at all it was very brief. I put an ice pack on her next and rubbed her arm. A technician called EMS. After about 10 minutes she became more talkative and felt better. EMS came and checked her out.
Dizziness & myalgias and malaise; Dizziness mimicked BPPV, and worsend over 3-4 days, mild myalgias abated over 2 days, malaise 3 days-mild. Dizziness became quite remarkable
arm ached & couldn't use 10DEC12; 1 wk later devel swelling & soreness of joints;
6 days of heavy periods with large clots up to this morning. First time after several years of only light spotting (IUD/premenopausal). Lighter menstruation today.
vaginal bleeding.  I believe that it is a regular period.  The reason this is concerning is because I have been in full menopause for almost 3 full years.  I contacted gynecologist already.
About 4 hours after receiving vaccine, client developed a bad headache and felt tired. Around 7:30pm had pain, swelling, redness, heat @ injection site and developed a stiff neck. Pt. called physician. 10/28/14 symptoms continued with development of dizziness & fatigue. Redness was about 4.5 inches in diameter. Pt went home about 1:30. 10/29/14-no change. 10/30/14 pt woke up with hoarseness. Redness decreased to 4 inches. Injection site tender and warm to touch. 10/31/14 pt stayed home. 11/3/14 pt improving. Continues with hoarseness and tender to touch.
vomiting and diarrhea at night {3 nights after oral Rotavirus vaccination}
Patient was 17 years old when he received 1st Moderna vaccine and CDC/DOH recommendation was to receive the 2nd vaccine in the series 4 weeks later. At this time Moderna is only approved for 18 years and older. No reaction noted.
Injection was received at approx 11:50am 10/9/07.  At about 9pm that day pt. stated her arm "got real sore & started to ache".  Reported that throughout the night the pain radiated into shoulder & neck.  Not relieved with Motrin.
Lump and swelling in left breast for  first vaccine ; had an emergency doctors office visit with a breast surgeon; had an ultrasound . Also had a follow up diagnostic mammogram and ultrasound .  2nd vaccine I suffered with asthmatic exacerbation and was hospitalized. I have had  asthma my entire life and never experienced this before.
This spontaneous report as received from other (purchaser) refers to a patient of unknown age and gender. On an unknown date the patient was vaccinated with PNEUMOVAX23 (dose, route, lot number and expiration date not reported). There was no concomitant medication reported. The reported mentioned that a nurse stated that the patient could have received expired PNEUMOVAX23. No adverse effects reported. Additional information has been requested.
pt recvd vax & 15 mins following vax pt exp periorbital edema, tachypnea, tachycardia, bronchospasm; Emergency teams called pt was stabilized & taken to ER;
Pt. complained of significant dizziness, nausea, and anorexia beginning 12-24 hours after the vaccination and continuing for 5 days post-vaccination. The patient visited their PCP on 09/23/2019 who diagnosed the patient with a significant immune response to the vaccination, not requiring follow-up. The PCP documented "dizziness" as the reason for pt. visit.
hard lump at and around the injection site; around the injection site that occasionally itched; This spontaneous case was reported by a patient and describes the occurrence of VACCINATION SITE MASS (hard lump at and around the injection site) and VACCINATION SITE PRURITUS (around the injection site that occasionally itched) in a 37-year-old female patient who received mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (batch no. 024H22A) for COVID-19 prophylaxis.     Patient had no known allergies and there was no parental vaccine exposure.  The patient's past medical history included Idiopathic thrombocytopenic purpura (child acute ITP when they were like 27 months old but is on no medication). Previously administered products included for Product used for unknown indication: Influenza. Past adverse reactions to the above products included No adverse event with Influenza. Concomitant products included INFLUENZA VACCINE (FLU [INFLUENZA VACCINE]) from 16-Dec-2022 to an unknown date for an unknown indication.    On 16-Dec-2022, the patient received third dose of mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (unknown route) 1 dosage form. On an unknown date, the patient experienced VACCINATION SITE MASS (hard lump at and around the injection site) and VACCINATION SITE PRURITUS (around the injection site that occasionally itched). At the time of the report, VACCINATION SITE MASS (hard lump at and around the injection site) and VACCINATION SITE PRURITUS (around the injection site that occasionally itched) outcome was unknown.        For mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (Unknown), the reporter did not provide any causality assessments.   Patient took first dose on 14-Jan-2021, Lot number 026L20A, took second dose on 11-Feb-2021 Lot number 032L20A.  No treatment information was provided.   This case was linked to MOD-2022-690523 (Patient Link).
Patient received booster dose of vaccine before recommended schedule of 5 months (in this case, approximately 3 months).
on 06/09/2021 experienced rapid heart rate, went to HCF, was transferred to another HCF.  Spent 2 days in the hospital being monitored for the rapid heart rate.  All blood work done, EKG, Echo, Stress test, chest xrays were completed.  Upon discharged on 06/11/2021  was ordered a chest heart monitor.  That was fitted on 06/14/2021 and wore that for 30 days until 07/13/2021,  Meet with Dr on 07/27/2021  results of tests and heart monitor were discussed with results of heart monitor showing some small episodes while wearing.  At this time continuing to being watched for further symptoms.
Headache, Myalgia, Fever, Chills, Fatigue, Left axillary lymphadenopathy Narrative:
Headache that began at 8:00 pm on the night that the vaccine was given and mild pain and swelling at the injection site.  Headache has not gone away (and she does not describe as a migraine).
About 24 hrs after ZOSTAVAX, had soreness and an approximately 5 in. diameter red area around injection site. 48 hours later, soreness has improved. Left arm.
This spontaneous report was received from a physician via a company representative, referring to a patient of unknown age and gender. No information regarding the patient's medical history, concurrent conditions or concomitant therapies was provided. On 10-MAR-2015, the patient was vaccinated with the improperly stored dose of PNEUMOVAX 23 " 10 PK 0.5 ml SD-PFS LLok wTip" lot number K009106 with expiration date of 25-FEB-2016 (dose number, route of administration and anatomical location were not provided), which was stored at -2.77 Celsius Degrees for 480. The type of excursion was refrigerator. No adverse effects were reported. No product quality complaint was involved. This is one of several cases from the same reporter. Additional information has been requested.
Information has been received from a physician concerning a 20 year old female with allergic reaction to doxycycline, who on 19-OCT-2007 was vaccinated with the first dose of GARDASIL.  On 14-DEC-2007, the patient was vaccined with the second dose of GARDASIL IM.  There was no concomitant medication.  In December 2007, the patient developed an allergy to gluten.  On 24-DEC-2007, the patient developed hives that resolved on its own.  She had seen a hematologist/oncologist, endocrinologist, and Gastroenterologist.  The physician mentioned that the specialist were not able to determine a cause for the gluten allergy.  The patient had significant abdominal pain, upset stomach, weakness and fatigue.  She had a 10-15 weight loss.  In October 2007, she weighed 115 lbs and on March 18 2008, she weighed 101 lbs.  Testing for Celiac disease were negative.  Immunoglobulin A (IgA) was low positive in March, 2008.  Repeated testing for Celiac disease in March 2008 was negative.  Subsequently, the patient recovered from the adverse events.  The patient sought medical attention.  Additional information has been requested. 10/07/08-records received-Yasmin OCP. Placed on gluten free diet now feels great and has energy, and gaining weight. 10/7/07 first Gardasil vaccination given. Right ear pain and weight loss.
after getting the first  dose of moderna on 8/18/21, I had muscle soreness and a little fatigue that night. On Monday morning 8/23 I woke up having trouble speaking, otherwise I felt fine. Tuesday (the next day) I woke up with vertigo, a headache, a very vague sense of disorientation, nausea, ringing in my ears, confusion and slow responsiveness. I felt intoxicated to the point that I couldn't work or complete daily tasks.  On Wednesday 8/25 I went to see my primary care physician and he gave me a methyprednisalone taper. Over the course of the next week after the taper I felt no better, and I still felt very intoxicated, confused, lightheaded, constant headaches, I space out constantly and I generally feel like I'm about 20% of my typical mental baseline. Its hard to even function properly. I cannot handle more than one thing at a time and I have become very scared and depressed that I will never return to normal. I have a constant ringing in my ears and I have a lot of difficulty sleeping, its like my mind begins to panic when I start to doze off. I have been out of work for almost a month and I'm not seeing any improvement in my cognitive disability.   I have been a work from home software developer for almost 2 years now and I have never had any health problems, or psychiactric issues before this. I didnt start becoming depressed until a week or so after this started and hearing multiple doctors tell me that they dont know whats causing this or how long I will be like this.
Nausea; Chills; This is a spontaneous report from a contactable consumer via a Pfizer-sponsored program,. A female patient of an unspecified age received bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE), via an unspecified route of administration on 19Dec2020 at a single dose for COVID-19 immunisation. Medical history and concomitant medications were not reported. The patient experienced nausea and chills on an unspecified date. Clinical outcome of the events was unknown.  Information about lot/batch number has been requested.
within 48 hours felt onset of pins/needles tingling in his toes, worse on the left and subsequently developed left sided ulnar neuropathy (had experienced previously but not in some time) as well as perioral numbness/tingling; his symptoms improved transiently with 600mg ibuprofen and now that we are ~2 weeks out only involve his left foot but do persist.  He underwent an EMG that was essentially normal and has no other symptoms to suggest demyelinating disease.