chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Short Summary: DVT followed by Multiple Bilateral Pulmonary Embolisms (significant blood clots in both lungs). Context: After the first vaccine (about a week before my second vaccine), I self diagnosed myself with a calf injury due to extreme pain in my calf that felt like a continuous cramp. The extreme pain lasted until my second shot (about a week). When going for my second shot, I reported a rash with hives on my lower abdomen that had appeared within five hours of my first shot, so they requested I stay a little longer for observation. That night I began having some breathing difficulties, but assumed they were to be expected. The breathing difficulties continued to get worse until my nurse practitioner told me to go directly to the nearest ER (2/16/21), where I was officially diagnosed with multiple bilateral pulmonary embolisms. I was admitted to healthcare facility for 24-48 hours, until an EKG revealed heart abnormalities that caused them to use a physician's transport to move me to another unit. I was discharged from the hospital on 2/2/21 after I stabilized from heparin shots, avoiding more invasive procedures. I have been in ongoing recovery since then, receiving ongoing care from a hematologist and pulmonologist. A little extra context for you - I arrived to the hospital with diabetic ketoacidosis and have an endocrinologist since hospitalization that has diagnosed me with Type 1 Diabetes (previously misdiagnosed as type 2 - I'm now on insulin which is controlling my blood glucose well).
Pt's mother reports, red swollen area approx the size of a quarter at injection site. No fever reported.
This literature marketed information has been received from a published literature article title and refers to 27 patients younger than 65 years old. The patient's concurrent conditions, medical history and concomitant therapies were not provided. Prior or after the protocol implementation on an unknown date, the patients were vaccinated with PNEUMOVAX 23 (dose, route, vaccination site were not provided), for prophylaxis, which should not have received a vaccine at the time. This is one of two reports from the same literature (US-009507513-1903USA001313, US-009507513-1902USA002078, US-009507513-1902USA002078 and US-009507513-1903USA001316). Sender's Comments:  US-009507513-1902USA002078: Original Case: 1902USA002078.
Fast heart beat/can not get their heart beat down from 90/I can't get my pulse down below 90. When I go to bed it goes low when I'm up around it goes 93. This spontaneous case was reported by a consumer and describes the occurrence of HEART RATE INCREASED (Fast heart beat/can not get their heart beat down from 90/I can't get my pulse down below 90. When I go to bed it goes low when I'm up around it goes 93.) in an 81-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 0317F21A) for COVID-19 vaccination.     No medical history was provided by the reporter.  Concomitant products included LORAZEPAM, IBUPROFEN (ADVIL [IBUPROFEN]), DOXYCYCLINE and VITAMIN D3 for an unknown indication.   On 15-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 23-Oct-2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 24-Oct-2021,  after starting mRNA-1273 (Moderna COVID-19 Vaccine), the patient experienced HEART RATE INCREASED (Fast heart beat/can not get their heart beat down from 90/I can't get my pulse down below 90. When I go to bed it goes low when I'm up around it goes 93.). At the time of the report, HEART RATE INCREASED (Fast heart beat/can not get their heart beat down from 90/I can't get my pulse down below 90. When I go to bed it goes low when I'm up around it goes 93.) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 23-Oct-2021, Heart rate: 90 (abnormal) Patient heartbeat was 90..         First dose of COVID-19 batch lot number was rusph .  Concomitant medications includes blood pressure medicine  Patient did not took anything to treat the side effect.   This case was linked to MOD-2021-362847 (Patient Link).   Most recent FOLLOW-UP information incorporated above includes: On 24-Oct-2021: Follow up appended includes vaccine dose date update and concomitant medication added
Laboratory tests results confirmed that she was infected by the COVID-19 virus/she found to be an asymptomatic patient for COVID-19 infection; Laboratory tests results confirmed that she was infected by the COVID-19 virus/she found to be an asymptomatic patient for COVID-19 infection; she did not received the second dose of the Pfizer's COVID-19 vaccine; she did not received the second dose of the Pfizer's COVID-19 vaccine; Fever; This is a spontaneous report from a non-contactable consumer . This female consumer reported that she received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE (Solution for injection) via an unspecified route of administration as a single dose for COVID-19 immunization in the first week of January. The consumer reports that in Jan she was installed at a nursery home and there were multiple cases of COVID-19 infection that affected the staff and the members installed there. Two days after that she had fever but she was not admitted in the hospital despite the laboratory tests results confirmed that she was infected by the COVID-19 virus. The consumer reports that she found to be an asymptomatic patient for COVID-19 infection. The consumer reports that she was transferred to another nursery residence and because of that and her quarantine after being infected with the COVID-19 virus she did not received the second dose of the Pfizer's COVID-19 vaccine which led to missed dose and incomplete course of vaccination. The outcome for the events was unknown.  The consumer reports that she spoke with agent  before being transferred to Pfizer. AE for the missed second dose of the Pfizer's COVID-19 vaccine due to COVID-19 quarantine.   No follow-up attempts are possible; information about lot/batch number cannot be obtained.
Redness, warmth, induration 2"x 2 1/2" to injection site. Pt. reports site is painful to touch.
Pain at injection site  15 minute after shot. Swelling at injection site, 3inx3in hot to touch, itching that lasted for 11 days post injection.   After the swelling went down discoloration and itching in the same spot is ongoing 25 days post Shot.  Rashes on back and ankle on the left side of body.  In addition to chill lasting 3 days, fever of 101 lasting for 3 days  and fatigue that lasted for 5 days.
This spontaneous report was received from a pharmacist who was also the patient's wife, concerning a 48 years-old male patient. The patient's concurrent conditions included allergy to sulfa drugs. The patient did not have medical history or concomitant medications. On an unspecified date in November or December 2016, while the patient's wife administered a dose of ZOSTAVAX 19400 plaque-forming unit (PFU) with its sterile diluent (manufacturer unknown) (lot #, expiration date, dose, route of administration or anatomical location were not reported for both); some of the vaccine could have gotten on her person, which caused shingles rash in the patient about 2-3 days after (Herpes zoster/Secondary transmission). Subsequently, he was diagnosed with shingles by his primary care physician, who prescribed him an unspecified antiviral medication and unspecified pain medication. No laboratory diagnostics studies were performed. The pharmacist reported that the shingles caused a significant incapacity, as the patient was unable to attend work for 2 weeks. The patient fully recovered from the events 3 weeks after the symptoms began on an unspecified date in 2016, and he did not have any residual symptoms. The causal relationship between the ZOSTAVAX and the events was not provided. No product quality complaint (PQC) was involved. This is one of two reports received from the same reporter. Sender's Comments: US-009507513-1708USA006411.
This case was reported by a other health professional via call center representative and described the occurrence of stiff neck in a female patient who received FLUARIX QUADRIVALENT (batch number CS979, expiry date 14th June 2017). On 25th October 2016, the patient received FLUARIX QUADRIVALENT (intramuscular). On 26th October 2016, 1 days after receiving FLUARIX QUADRIVALENT, the patient experienced stiff neck. On an unknown date, the outcome of the stiff neck was not recovered/not resolved. It was unknown if the reporter considered the stiff neck to be related to FLUARIX QUADRIVALENT. Additional details were provided as follows: The age at vaccination was not reported. It was unknown if the patient had any relevant medical history. The patient received FLUARIX QUADRIVALENT on left arm. It was unknown if there were any other suspect or concomitant products involved. This case was not associated with product complaint. There were no seriousness criteria (death, hospitalization, disabling, congenital anomaly, life-threatening and clinical intervention required) associated with the reported event.
pt recv vax 25AUG98 AM & later the same morning pt devel dizziness, diaphoresis & lost hearing in the lt ear;
Given Day 1 is the day vaccine administered. Day 1 fatigue, sore arm. Day 2 very ill; muscle and joint aches, extreme fatigue, headache, sore arm, dizziness. nausea. Day 3 very mild symptoms; headache, dizziness, nausea. Day 4 nasuea, slight itching of eyelids, fingers, sore arm. Day 7, sore arm resolves. Day 9 itching intensifies, red spotted rash on chest, crotch, inner thighs,  underarms, back of scalp, feet and hands that become raised welts if touched or scratched. Seems to be a histamine reaction.  Day 13 injection site is painful and swollen. It is now Day 14 and the rash/histamine reaction continues and injection site is swollen and painful.
Left arm burned where injection was given. Tingling/ numbness in left forearm and hand since injection.  Twitching in forearm.
Redness and swollen Rt. Arm, Ibuprofen 600mg, Doxycycline 100mg.
firmness, swelling, itchiness at injection site ~6 days post first shot. self medicated with benadryl.
Systemic: Dizziness. Patient sat for 45 mins after vaccine. Agreed to oral benadryl 25mg. Felt better within 10 minutes. Issue resolved
Had episode of emesis and hypersensitivity after vaccine. Resolved with breathing in paper bag.
Dose received: 3; Fatigue; Malaise; Pain at injection site; Irritability; This is a spontaneous report from a non-contactable reporter (consumer or other non-HCP).   An adult female patient received bnt162b2 (BNT162B2) (Lot number: unknown) as dose 3 (booster), single for COVID-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: Bnt162b2 (DOSE 1, SINGLE, Lot number: UNKNOWN), for COVID-19 immunisation and Bnt162b2 (DOSE 2, SINGLE, Lot number: UNKNOWN), for COVID-19 immunisation.  The following information was reported: IMMUNISATION (non-serious), outcome "unknown", described as "Dose received: 3"; FATIGUE (non-serious), outcome "recovering", described as "Fatigue"; MALAISE (non-serious), outcome "recovering", described as "Malaise"; VACCINATION SITE PAIN (non-serious), outcome "recovering", described as "Pain at injection site"; IRRITABILITY (non-serious), outcome "recovering", described as "Irritability". Therapeutic measures were not taken as a result of fatigue, malaise, vaccination site pain and irritability. Additional information: Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. The events did not result in doctor or other healthcare professional office/clinic visit, emergency room/department or urgent care.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
80y.o. female with PMHx including ESRD on PD who was admitted on 8/23/22 for hypotension, fatigue/weakness, and falls. She was found to be hyponatremic with NA 114 and COVID+, completed Remdesivir. Hospitalization complicated by NSTEMI, found to have new EF of 20%. Cardiac catheterization on 8/29 notable for minimal CAD. She reports dry heaves but no vomiting. States nausea is sometimes correlated to her therapy sessions. She also related nausea to PD exchanges. She is able to tolerate some PO intake, but appetite is poor. She reports recent diarrhea that is now improved. Patient to discharge home with family/social support.
Information has been received from a nurse referring to multiple unspecified patients of unknown age and gender. Concurrent condition and medical history of the patients were not reported. On unknown dates the patients were vaccinated with doses of improperly stored PROQUAD (Merck) (lot # L051098, Expiration date: 17-JUN-2017; Lot# M01152, Expiration date: 05-JUL-2017) (dose and route were unspecified). The vaccine has been stored in -13.2 degree centigrade for 26 hours. This is one of several reports received from the same source. Additional information has been requested.
PT received the vaccine and slumped over on the table, was caught by a nurse and was unresponsive. PT fell backward in his chair and was unresponsive. PT fell backward in his chair and was caught by paramedic on scene. PT did not hit head at any point. After being caught the PT was roused and responded  to  his name. Total time unresponsive was approximately 10-15 seconds. After being roused PT was placed on a stretcher using sit-pick movement technique, brought to a private location and assessed. Assessment revealed PT to be a&Ox4 GCS 15, blood pressure 116/70, pulse 84, RR 18, skin signs pale, cool, dry, pupils equal and reactive to light and motion, 6mm in diameter. During assessment PT  was asked about medical history. PT stated that he had an allergy to penicillin as a child that included a rash and no anaphylactic reaction. PT stated that he had laparoscopic surgery for two hernias in approximately august of 2020. PT also stated that he has a history of syncopal episodes, usually during blood draws,  but never during an injection or vaccination before. PT was reassessed approximately 5 minutes after the initial assessment. PT was  A&Ox4 GCS 15, BP 122/72, PR 76, RR 16. Skin S:Warm, Dry, pink, PEARL-5mm. PT was given water, color improved and mentation remained normal/intact.  PT was urged to contact a doctor for more definitive evaluation at his earliest continence.  PT observed for 30+ minutes with no recurrence of symptoms, denying pain, dizziness, or any other complaint. PT reassessed prior to leaving clinic. PT was A&Ox4, GCS 15, BP 122/76. PR 64, RR 16, Skins: Pink, warm, dry, PEARL-4mm. PT left facility at 11:32am accompanied by two acquaintances who also received vaccine .
Swelling of joints, migratory polyarthritis, diagnosed 5/5/06, RX prednisone, Lasix started 5/2/06, cellulitis diagnosed 10/21/06 welt, rash on face, RX Prednisone, Cipro.
Systemic: Hypertension-Medium, Additional Details: PT REPORTED SORE ARM THE DAY AFTER BUT IT SUBSIDED A DAY AFTER. SHE DID NOT FEEL ANYTHING DIFFERENT UNTIL A CHECK UP IN JAN 2021 REVEALED HIGH SYSTOLIC BP OF 220. SHE REPORTED THAT PRIOR TO VACCINATION, SHE NEVER HAVE ANY CARDIAC OR BLOOD PRESSURE ISSUE. NOW HER BP IS MANAGED WITH ORAL ANTIHYPERTENSIVE
Increased heart rate to 110 bpm within 15 minutes of  vaccine, lasting for 40 minutes, headache within 15 minutes of vaccine that lasted the whole day , dizziness and shakiness with in 15 minutes that lasted about 30 minutes.
Rash on thigh at injection site develop on 9/22/08.  Local reaction to VARIVAX.  Erythematous maculo/papular rash to trunk developed today 9/23/08 and is developing.  Noting some rash starting on face - behind ears.  Rubella rash."
pt recvd vax; pt did not seem to know who she was,woke up p/ nap p/ leaving here 3jan95;then was extremely cranky for over a wk thereafter;
Rash bilateral arms, began on right arm within 24 hours post vax. Rash later spread to both arms and legs.
The spontaneous report as received from a medical assistant refers to a 31 year old patient of unknown gender. There was no information about the patient's concurrent conditions, concomitant therapies or medical history provided. On 05-JAN-2016, the patient was vaccinated with an improperly stored dose of M-M-R II lot # K000174, expiration date: 08-JAN-2018 (exact dose, route of administration, therapy type and anatomical location were not provided). On 25-APR-2016, the patient received again an improperly stored dose of M-M-R II lot # L007216 with expiration date: 03-MAR-2017 (exact dose, route of administration, therapy type and anatomical location were not provided). This is one of several reports received from the same reporter. Additional information has been requested.
3/30/2023 it started like a dry cough. I took an at home COVID tests for 4 days and they all came back negative. On April 1, I was fatigued, coughing routinely and unable to get out of bed. I had chills and sweats that night. On 4/2,12  I went into the clinic. They did not want to give me the flu medication. I was given something for nasal congestion. I did not have any tests done. The next day, I was progressively getting better.
This spontaneous report as received from a registered nurse refers to a patient of unknown age and gender. On an unknown date, the patient was vaccinated with a dose of improperly stored ROTATEQ (2 ml, oral, lot number and expiration date were not reported). No adverse effects were reported. Additional information has been requested.
Day 0 day of vaccine tingling hand post injection  Day 1 sore arm 24 hrs Day 2 nothing  Day 3 tingling lips, hand, middle finger pain Day 4 middle finger pain, tingling/burning spot on leg Day 5 nothing  Day 6 leg pain, numb, tingly, burning sensation  Day 7-8 finger pain, decreased sensation to left side  Day 9-10 finger pain, chest pain  Day 11 tingling left shoulder  Day 12 decreased sensation left side  Day 13 weakness with left side and grip strength  Day 14 sharp shooting pain left back
redness-tenderness;swelling-hot to touch @ site rt deltoid 25JAN96;APAP given;29JAN96 TC arm itchy w/tenderness @ site;swelling & pain
This spontaneous report was received from social media "Revolution For Choice", via a vendor regarding a 16 year old female patient. The patient's medical history, concurrent condition and concomitant medications were not reported. On an unknown date, the patient was vaccinated with GARDASIL (dose, frequency, route of administration, lot # and date of expiry were unknown) for prophylaxis. On an unknown date, the patient experienced swollen brain (brain oedema), anxiety, no movement (hypokinesia), tingliness (paraesthesia), pain/extreme pain/body pain, constant nausea, worst start to hurt her knees and back (back pain and arthralgia. The outcome of anxiety, back pain, body pain, arthralgia, nausea, pain, paraesthesia, hypokinesia and brain oedema was unknown. On 12-OCT-2013, the patient had died suddenly on bed. The cause of death was not reported. It was not reported if autopsy was performed. The causality assessment was not reported. Upon internal review, event of brain oedema was considered to be medically significant. This is one of the several reports.; Reported Cause(s) of Death: sudden death.
Intradermal flu vaccine - immediate raised up to a small ring and was red, muscle aches x 2 weeks.  4/18/17 employee complains injection site "has grown and has turned red". "There is a hard lump that has raised even more as time has went on. One provider thought it has turned to scar tissue."
fever, chills, aches pains, shivering uncontrollable, dizziness
Fever that eventually reached 104 F; achy all over; nausea; headache; worst I have felt in years.
Pt was inadvertently given an expired Hep A. dose. She was immediately notified and monitored for 30 minutes post with only redness to the site. Manager notified. Vaccine Expiration date 2/26/22. Pt also received a valid Hep. B dose on same date, same arm per her request.
Unusually heavy menstrual bleeding with very large clots. Atypical for patient. Low back pain associated with menstrual cycle. Also atypical for patient.  Began day 1 of vaccine dose 2. Continuing into day 2 after vaccine dose 2.
Numbness and weakness Left Leg; Numbness and weakness Left Leg; diagnosis Guillain Barre; This is a spontaneous report from a contactable consumer (patient). A non-pregnancy 55-year-old female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection), via an unspecified route of administration, administered in right arm on 24Mar2021 at 13:15 (at age of 55 years old, no pregnancy, Lot Number: EP6955) as a single dose for covid-19 immunization. No medical history and concomitant medications. No known allergies. Prior to vaccination, the patient was not diagnosed with COVID-19. On 21May2021, the patient experienced numbness and weakness left leg. On 29May2021 Emergency room misdiagnosed Sciatica couldn't bear weight used wheelchair. Went to primary 02Jun2021, followed by Neurologist diagnosis Guillain Barre. Confirmed by spinal tap at hospital after ER visit and 5 day stay at hospital with immunoglobulin treatments. AE resulted in: Doctor or other healthcare professional office/clinic visit, Emergency room/department or urgent care, Hospitalization, Life threatening illness (immediate risk of death from the event), Disability or permanent damage. Since the vaccination, the patient was not had been tested for COVID-19. The outcome of the events was not recovered.
Sore arm for almost a week, body aches started 2 days out from shot and continued for 4 days, felt very tired/fatigued for 1 week.
Left Occipital Neuralgia  Severe pain radiating through the left side of my neck through my head and ear causing pain, nausea, and dizzyiness. lasting 3 weeks and returning off and on.
Actually, on the day of getting the booster shot, about 2.5 hours after, I felt myself dizzy with light feet and not as conscious as normal. It lasted less than 30 minutes. On the morning of second day, 01/13/2021, when I got up at 7:44, I felt hard to breath, short of breath and I even could not stand straight or talk with the normal voice. Then, I measured my blood pressure which was low and heartbeat which was not stable and went up to 104 beats per minute.  I was so confident to get my booster shoot as there was no symptoms after my first two shots of the same vaccine. So what happened to the third shot? Is the vaccine in larger dose and/or having something wrong before it injected to me? My husband , who took the Pfizer-Bion booster on 01/05/2022 at the same place of mine, College Center , more than six months after his two Moderna vaccines, has felt about 5 degree of heart pain for four days.
Breakthrough case admission after 3 vaccines Moderna 1/28/21 Lot# 028L20A;  Moderna 2/25/21 Lot# 004M20A;  Moderna 10/5/22 Lot# 027E22A
Red, dotted rash that covered entire anterior and posterior torso (chest, breasts, neck, shoulders, axilla, entire back), groin, inner thighs, and buttocks, causing significant itching. The rash lasted 3 days, and resolved with daily use of Benadryl , itching continued for 5 days
This spontaneous report as received from a healthcare worker refers to a patient of unknown age. The patient was vaccinated with a dose of 0.5 ml PNEUMOVAX23 on 19-OCT-2012 at a doctor's office. On 15-JAN-2013 the patient was vaccinated with another dose of PNEUMOVAX23 at a different doctor's office. No AE was reported. Additional information has been requested.
Youth has 3 x 4" swollen red area where he received varicella vaccine the following day.