chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Within a few days I became ill with a sore throat and fever, then a cough and wheezing. My cough became worse, I began to have heart burn, sores in my mouth, and then severe pain in the knees.  Soon after there were vaginal sores, and pain in other joints. This progressed until I was unable to walk or take care of myself.  Over time, with medication and various other treatments I was able to walk some, dress myself, and do some other things for myself, but I was not even at 50% of what I was prior.  Since then I have been enduring severe pain in my joints, sores, extreme fatigue, headaches, trouble sleeping because of the pain, and various other ailments.  I have had numerous tests and treatments, and am about to embark on additional treatments, such as gamma globulin shots, anti-virals, thyroid medication, etc., in hope of getting back some of my health and life, if not all.  9/28/09 Clinical summary received from provider.  Within 1 week of receiving Hep B vax, pt developed muscle pain, joint pain, swelling of ankles, severe fatigue and lassitude.  PE (+) for appearing chronically ill, ankle edema, joint and muscle tenderness.  DX:  Acquired autoimmune disease caused by antigen in the Hep B vaccine.
Around 3:30 PM 12/22/14 shaking chills, aches, and 99.8 temperature. Took TYLENOL, finished, work, and went to bed at 6:15 PM. Chills, fever, aches, headaches have continued only to be relieved by TYLENOL. Tested negative for flu at pharmacy. No respiratory issues. Have taken 2 - 3 naps per day. Low energy level - only do what is necessary. This morning temp was 99.8 and 6 hours later after taking TYLENOL around 6 AM, 100 degrees. Trying to limit TYLENOL ES to 3 per day since I have been taking TYLENOL since 12/22/14. Dr. says to continue with TYLENOL. It is very unusual to have fever for greater than 7 days.
11:58 am, Immediately after injection c/o lightheadedness + feeling about to pass out.  B/P 88/50, HR 54, O2 Sat 98%, refused blood sugar.  Stated when he sees a needle he has this reaction. Refused to exit vehicle and transport to EMS truck for further monitoring.   Head of seat reclined and advised to put legs and knees up.  12:35 pm  B/P 123/56, 12:37 pm99/59, 12:40 pm 108/58.  Head of seat returned to sitting position. knees down, stated her feels better.  Released to observation area for further monitoring.  1:06 pm, released from observation.  Stated felt much better.  Advised symptom reappears, pull over and dial 911.  Acknowledged understanding.
headache, severe bone pain all over body,  joint pain,  muscle aches, weakness, vertigo, dizziness, chills, nausea, no appetite for 2 days
Patient received vaccine on 9-10-10 in morning.  Patient presents to pharmacy 9-13-10 in morning with severe bruising (4" long) about 2" under vaccine administration site on (R) upper arm.
skin started to clear prior to starting xeljanz and after first pfizer; This is a spontaneous report from a contactable consumer other hcp (patient). A 71-year-old male patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, formulation: solution for injection, lot number was not reported, expiration date was not reported), via an unspecified route of administration on an unspecified date as dose 1, single for covid-19 immunization. The patient also received tofacitinib citrate (XELJANZ, Batch/Lot number was not reported, 5 mg, 2x/day), via an unspecified route of administration from 01Apr2021 and ongoing for psoriasis, eczema. The patient medical history included psoriasis, eczema. Concomitant medications were not reported. It was reported that patient is taking xeljanz for off label diagnosis of psoriasis and eczema. no adverse event reported. he reports skin started to clear prior to starting xeljanz and after first Pfizer covid-19 vaccine. he started xeljanz after first vaccine and skin was clearer than it had been in a long time. md aware. The outcome of the event was unknown.  Information on the lot/batch number has been requested.
Fever, Diarrhea, chills, sweating, weakness beginning 7 hours after injection. Hospitalized due to these symptoms on March 10, and died on March 13.
indication=Treatment of COVID-19; indication=Treatment of COVID-19; This is a spontaneous report received from a contactable reporter(s) (Physician). The reporter is the patient.  A 48-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 28Sep2021 as dose 3 (booster), single (Lot number: FF8841) at the age of 47 years, in left arm 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 had no relevant medical history. Patient had no known allergies. There were no concomitant medications. The patient had no other medication in 2 weeks. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant) all with onset May2022, outcome "recovered" (25May2022) and all described as "indication=Treatment of COVID-19". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (unspecified date) Unknown results; (May2022) Negative, notes: I tested negative on day 8 and 9; (16May2022) Positive, notes: I retested positive on day 12; (25May2022) Negative, notes: I finally retested negative on day 21 (or day 10 from retest). Therapeutic measures were taken as a result of drug ineffective, covid-19. The patient received Paxlovid for COVID-19 from 05May2022 to 09May2022. Patient tested negative on day 8 and 9. She retested positive on day 12 (16May2022 07:00 AM). She developed body aches, mild cough, congestion, and rhinorrhea on days. She finally retested negative on day 21 (25May2022) (or day 10 from retest).; Sender's Comments: Based on the information in the case, an association between the reported events and the suspect product BNT162B2 cannot be ruled out.
Green diarrhea approximately 1.5-2 hrs after vaccination. Followed by sulfur order. Was fine afterwards.
red arm, pain, fluid underneath skin. dr wrote steroid cream to treat does not believe it is cellulitis
Nausea at ~ 1:00 PM  Low-grade fever (~100F), pain at injection site; vomiting started ~ 2:00 PM, unable to perform usual activities. Continued vomiting every 15-30 minutes until ~8:00 PM.  Administered Pepto for children (1 Tab) (vomited).  Gave Saltines (vomited)  Called on-call Dr. at facility:  advised to stay course and increase fluids.
Woke with bitemporal headache/pressure. At 8:00 am noted itching and hive like swelling left side of forehead.  Felt warm and felt heart beating faster.
Fatigue; Tightness in arm: 1 or 1.5 out of 10 (at the most, 4/10); This spontaneous case was reported by a consumer and describes the occurrence of MUSCLE TIGHTNESS (Tightness in arm: 1 or 1.5 out of 10 (at the most, 4/10)) and FATIGUE (Fatigue) in a 74-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 001AC1A) for COVID-19 vaccination.     Concurrent medical conditions included Myasthenia gravis (Patient was possessing a rare disease myasthenia gravis and other complications from myasthenia gravis).    On 24-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 24-Feb-2021, the patient experienced MUSCLE TIGHTNESS (Tightness in arm: 1 or 1.5 out of 10 (at the most, 4/10)). On an unknown date, the patient experienced FATIGUE (Fatigue). The patient was treated with PARACETAMOL (TYLENOL) at an unspecified dose and frequency. On 25-Feb-2021, MUSCLE TIGHTNESS (Tightness in arm: 1 or 1.5 out of 10 (at the most, 4/10)) had resolved. At the time of the report, FATIGUE (Fatigue) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Concomitant product use was not provided by the reporter.  After receiving the vaccine patient also experienced fatigue which was same six to eight on ten points scale.   Most recent FOLLOW-UP information incorporated above includes: On 30-Apr-2021: Medical history information, additional event were updated.
At 1248 patient fainted, began to feel, cold and clammy, vital signs within normal rage. Patient reported light headedness while seating down. Reported no previous medical history. EMS called and released patient. We kept patient for 30 minutes in observation until father picked him up.
COVID 19 Treatment; COVID 19 Treatment; This is a spontaneous report received from a non-contactable reporter(s) (Physician).  A 75-year-old female patient received BNT162b2 (BNT162B2), on 10Jul2022 as dose 4 (booster), single (Lot number: FP7139) at the age of 75 years for covid-19 immunisation; coviD-19 vaccine (COVID-19 VACCINE), as dose 1, single (Batch/Lot number: unknown), as dose 2, single (Batch/Lot number: unknown) and as dose 3 (booster), single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history was not reported. The patient took concomitant medications in 2 weeks . The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant), outcome "not recovered" and all described as "COVID 19 Treatment". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: Positive. Therapeutic measures were taken as a result of drug ineffective, covid-19.  Clinical course: Paxlovid treatment was started in 21Jul2022 till 26Jul2022 for the treatment of COVID-19. On 03Aug2022, the patient experienced Rebound positivity with outcome as unknown.  No follow-up attempts are possible. No further information is expected.; Sender's Comments: Based on the known safety profile and Limited information in the case report a casual association between LOE events and suspect drug BNT162B2 cannot be excluded.
Large rash all over back; This is a spontaneous report from a non-contactable consumer, the patient. A 71-year-old female patient received an unknown dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: UNKNOWN) via an unspecified route of administration on an unknown date as a single dose for COVID-19 immunisation. Medical history and concomitant medications were not reported. On an unknown date the patient experienced large rash all over back for a month after vaccination. The clinical outcome of the event large rash all over back was unknown at the time of report.   No follow-up attempts are possible. Information about lot/batch number cannot be obtained. No further information is expected.
Swollen lymph node1 week after vaccination; This is a spontaneous report from a contactable consumer, the patient. A 54-year-old non-pregnant female patient received first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: ER8737) via an unspecified route of administration in the right arm on 07Apr2021 at 13:15 (at the age of 54-years-old) as a single dose for COVID-19 immunisation. The patient had no medical history and no known allergies. Prior to vaccination, the patient was not diagnosed with COVID-19. The patient did not receive any medications within two weeks of vaccination. The patient did not receive any other vaccine within four weeks prior to the COVID vaccine. On 14Apr2021 at 12:00, the patient experienced swollen lymph node, one week after vaccination which has not changed in two weeks. The event did not result in doctor or other healthcare professional office/clinic visit, emergency room/department or urgent care. Therapeutic measures were not taken as a result of the event. Since the vaccination, the patient had not been tested for COVID-19. The clinical outcome of the event swollen lymph node, one week after vaccination was not resolved at the time of the report. The patient received second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: UNKNOWN) via an unspecified route of administration on 28Apr2021 as a single dose for COVID-19 immunisation.  No follow-up attempts are needed. No further information is expected.
No additional  AE was reported; Pharmacist calling to report that a dose of ROTATEQ with a labeled expiry of 4/20/2022 was administered to a patient on 5/9/2022.; This spontaneous report was received from a pharmacist regarding a patient of 4-month-old patient of unknown gender. The patient's medical history, drug allergies, previously drug reactions, concurrent conditions and concomitant medications were not reported.  On 09-MAY-2022, the patient was vaccinated with a labeled expired rotavirus vaccine, live, oral, pentavalent (ROTATEQ) oral liquid, at a dose of 2 milliliters (ml) orally administered as prophylaxis, (lot number 1705097 which has been verified to be valid, expiration date reported and validated as 20-APR-2022) (expired product administered) (strength was not reported). No additional adverse events were reported.
Vomiting, diarrhea, fever, headache that lasted 2 days.  This was horrible, I very rarely ever get sick.  I do not want to get the second shot, especially since it's been reported that the second shot is worse.
Information has been received from a pharmacist referring to an unspecified number of patients of unknown age and genders. On unknown dates the patients were vaccinated with doses of ZOSTAVAX (lot#, dose and route unknown) which was possibly improperly stored under the temperature of possibly 8 F for 1 year. Data logger was reported as no. No symptoms was reported. Additional information has been requested.
Patient stated that after the vaccine she was having problems swolling for about 60sec. Arm so sore from shoulder to the risk. Pain felt like it was in the bones. About 10:30pm the caller woke up with extreme hot flashes. Her body was hot and could not get cool. This lasted about one hour and an a half. Patient said she was also having a headache. Patient stated that she was receiving hot fleshes and fatigue on Sunday, Monday, and Tuesday. On Wednesday patient received this extreme migraine headache and out of no where she felt disoriented and a extreme about of pressure in her head and her eye, Patient stated that she was having ringing in her ears. Patient also experience some blurred vision. Patient experienced loose stool. Week of the 14th patient started having these sharp pains in the abdomen and upper sternum.
Employee received Td booster IM on 10/01/2002. There was no immediate reaction. On 10/07/02, she started having pruritis on left deltoid (Td injection site) and noted erythema and swelling today (10/8/02).
Information has been received through a pregnancy registry from a 28 year old female consumer with no allergies, medical history, or previous pregnancies who on 5/10/04 was vaccinated with a 0.5ml dose of varicella virus vaccine live (lot # 646227/0536N). Additional suspect vaccination on the same day included 0.5ml dose of MMR (lot # 644417/1009M). There was no other concomitant medication. It was noted that prior to vaccination, on 4/27/04, the patient was tested for varicella antibodies and was found to be negative. The date of her last menstrual period was 4/15/04. The reporter indicated that she conceived on 4/26/04. Her estimated date of delivery was 1/10/05. Unspecified medical attention was sought. No diagnostic laboratory tests were performed. A product quality complaint was not involved. Follow up information was received from a physician who indicated that on 5/28/04, seven weeks from the patient's LMP, she had an elective termination of her pregnancy. It was unknown if the products of conception were examined. No further information is expected. ADDITIONAL INFORMATION: was received from a nurse who confirmed that the patient was vaccinated after having a negative urine pregnancy test. Subsequently, after vaccination, the patient's pregnancy tests was positive. The nurse confirmed that this was the only patient who became pregnant after vaccination. No further information is expected. This is a consolidation of two reports concerning the same patient.
Initially achy but this resolved and developed a golf ball sized soft tissue mass in the left supraclavicular region. Slightly tender. Does not appear to be a lymph node. No redness or warmth. No fever, nausea, itching, throat or facial swelling or difficulty swallowing.
This spontaneous report was received from a Registered Nurse referring to a patient of unknown age and gender. Information about the patient's medical history and concurrent conditions was not provided. On 29-FEB-2016, the patient was vaccinated with an improperly stored (Temperature:32F - Time frame: 5 minutes) dose of VAQTA (lot # L023232 and expiration date: 25-FEB-2017) (administration route was not provided). No concomitant therapies were reported. No adverse effects were reported. This is one of several reports from the same reporter. Additional information has been requested.
Hospitalization: 4/6/2023 - 4/8/2023 (2 days) Presentation to the ED: vertigo and dizziness COVID + date: 4/7/2023 Treatment: none. patient was asx.  Discharge to: home.  012L20A 1/7/2021 010M20A 2/4/2021 078J21A 12/22/2021
2/24/23 I woke up with a sore throat and earache. I continued to have a sore throat, earache and no fever. On 2/27/23, I tested negative with an at home COVID test. I continued to be tired and achy and felt like I had strep throat. I contacted my physician who did not prescribe any medications but to call back if I did not get better. On March 2,2023, I tested positive with an at home COVID test. I was tired and achy.
Body aches; Hypertension; Chest tightness; Shortness of breath; Headache; Chills; This is a spontaneous report from a contactable consumer, the patient. A 30-year-old male patient received the second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EW0170) via an unspecified route of administration in the arm left on 28Apr2021 at 09:30 (at the age of 30-years-old) as a single dose for COVID-19 immunisation. Medical history included antiphospholipid syndrome and possibly lupus. The patient was allergic to amoxicillin (MANUFACTURER UNKNOWN). Prior to the vaccination, the patient was not diagnosed with COVID-19. The patient did not receive any other vaccines within four weeks prior to the COVID vaccine. Concomitant medications included finasteride (MANUFACTURER UNKNOWN), hydroxychloroquine (MANUFACTURER UNKNOWN) and acetylsalicylic acid (ASPIRIN); all taken for unspecified indication since an unknown date and unknown if ongoing.  The patient previously received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: ER8729) via an unspecified route of administration in the arm left on 07Apr2021 at 15:00 (at the age of 30-years-old) as a single dose for COVID-19 immunisation. On 29Apr2021 at 06:00, the patient experienced body aches (day 2 only), headache, hypertension, chest tightness, shortness of breath and chills. The events resulted in doctor or other healthcare professional office/clinic visit, and emergency room/department or urgent care. Therapeutic measures were not taken as a result of the events body aches (day 2 only), headache, hypertension, chest tightness, shortness of breath and chills. On 06May2021, the patient underwent PCR (polymerase chain reaction) test (saliva) and the result was negative. The clinical outcome of the events body aches was resolved on 29Apr2021 while the clinical outcome of the events headache, hypertension, chest tightness, shortness of breath and chills were resolving at the time of this report.  No follow-up attempts are needed. No further information is expected.
I was at my apartment and started aching all over and then I was cold sweating the whole night and woke up still aching everywhere.
Developed a fever, reaching 101 degrees on Saturday (2nd dose of vaccine on Friday PM). Was also nauseous and fatigued, but I?m in the first trimester (8 weeks + 2 days at time of vaccine). Also had some cramping, but no spotting. Estimated due date is 12/8/21.
expired Engerix-B was administered to a patient; This non-serious case was reported by a nurse via call center representative and described the occurrence of expired vaccine used in a 21-year-old female patient who received HBV (Engerix B) (batch number 39TZ2, expiry date 07-SEP-2023) for prophylaxis.   On 12-SEP-2023, the patient received Engerix B. On 12-SEP-2023, an unknown time after receiving Engerix B, the patient experienced expired vaccine used (Verbatim: expired Engerix-B was administered to a patient).  The outcome of the expired vaccine used was unknown.   Additional Information: GSK Receipt Date: 12-SEP-2023 The nurse reported an patient received a dose of  Engerix-B on 12th September 2023,which was expired on 7th September 2023, which led to expired vaccine used. The reporter consented to follow up.
Large, circular, red rash that appeared at the injection site. This continued for 3 days. There was also a lump under my skin at the injection site that is still there today (8/31/2021). It has decreased in size but is still noticeable.
This spontaneous report was received from a medical assistant and refers to unspecified patients of unknown age and gender. No information regarding the patients' pertinent medical history, concomitant medication and drug reactions or allergies was reported. On unknown dates since 23-JUN-2015, the patients were vaccinated with doses of GARDASIL (lot # K023432, expiration date 18-JUN-2016; K008931, expiration date 04-MAR-2017) (strength, dose and route of administration were not provided) that were exposed to temperatures outside of recommended range. No adverse experience had been reported. This is one of two reports received from the same source. Additional information has been requested.
wasn't sleeping; tinnitus; This spontaneous case was reported by a consumer and describes the occurrence of SLEEP DISORDER (wasn't sleeping) and TINNITUS (tinnitus) in a male patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On an unknown date, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced SLEEP DISORDER (wasn't sleeping) and TINNITUS (tinnitus). At the time of the report, SLEEP DISORDER (wasn't sleeping) and TINNITUS (tinnitus) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No concomitant medications were reported. No treatment medications were provided.
Pt had VARIVAX immunization on 6-23-99 now has chickenpox
Had 2 doses then had booster in Nov.  Ended up in hospital with endocarditis.
This spontaneous report was received from a nurse and refers to a 64-year-old female patient. The patient's concurrent conditions, medical history, drug reactions or allergies and concomitant medications were not provided. On 10-NOV-2016, the patient was vaccinated with an expired dose of ZOSTAVAX lot# L028284, expiration date: 28-OCT-2016 (dose and route of administration were not reported). No adverse effects were reported. Additional information has been requested.