chrisvoncsefalvay/vaers-outcomes huggingface dataset:
From initial info received on 03/20/2003 from a medical assistant regarding an adverse event, it was reported that a 35-year-old female pt received an injection of Tetanus Toxoid, lot #U0737AA, administered in her right deltoid on 03/05/2003. That same day the pt experienced "pain and redness at site of injection, extreme flushing of skin, face and lip swelling". The pt reportedly did recover from these events. A similar event was also reported for another female pt who received an injection of Tetanus toxoid from the same lot (U0737AA) [see case 2003-00469 for details] on 03/04/2003. The reporter of this case is the same reporter of case 2003-00469.
Approximately 3 minutes after vaccination, sitting in chair and had a bout of dizziness and racing heart rate. This lasted about a minute. Ten minutes after, experienced flushing lasting about a minute as well.
2 days after second injection of Moderna, I developed hives and itching on Left am and left inner thigh. On the fourth day after, it spread to right arm and right inner thigh. Today is day 20 after the vaccine and still experiencing moderate generalized urticaria. Had taken Benadryl but doesn't help it just would make me sleepy.  Reported this to my workplace but had no response.
This case was reported by a other health professional via sales rep and described the occurrence of adverse reaction in a 37-year-old female patient who received Seasonal Influenza vaccine. On an unknown date, the patient received Seasonal Influenza vaccine at an unknown dose. On an unknown date, an unknown time after receiving Seasonal Influenza vaccine, the patient experienced adverse reaction. On an unknown date, the outcome of the adverse reaction was unknown. It was unknown if the reporter considered the adverse reaction to be related to Seasonal Influenza vaccine. Additional details were provided as follows: The age at vaccination was not provided. The details of the reaction was not reported. For tolerability after FLUARIX QUADRIVALENT, please see case US2016GSK166608.
A phone call was received from a reporter at a college. The reporter was covering a news story of a male service member of the military who received immunization with "Anthrax vaccine" and subsequently experienced spondylitis. No further information is available.
This spontaneous report was received from a healthcare worker and refers to a 7 week old patient of unknown gender. The patient's medical history, concurrent conditions and concomitant therapies were not reported. On 22-OCT-2015, the patient was vaccinated with a dose of improperly stored oral, ROTATEQ (dose was not provided) lot # K016261, expiration date: 23-JUN-2016, orally. No adverse effects were reported. Additional information has been requested.
Patient developed severe left arm and chest pain within 1 week of receiving 2nd COVID vaccine dose. She presented to ER and was admitted given her prior cardiac history. Chest x-ray, echo, CT left shoulder and scapula were all negative for acute process during admission (3/6-8/21). Left arm soft tissue ultrasound on 3/12 was also normal. Pain improved with hydrocodone/acetaminophen as needed and over the course of 1 month after vaccine.
Said her son startedexperiencing symptoms like cold,congestion, headache and scratchy throat on 05/02/2021and her son tested positive today05/05/2021.; Cold; Headache; Scratchy throat; Congestion; This is a spontaneous report from a Pfizer sponsored program. A contactable consumer reported for a male patient with unspecified age that he received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection) on 25Apr2021 at 1st dose, single for covid-19 immunisation. Patient's medical history and concomitant medications were not reported. The consumer was calling on behalf of her son, got the first dose of the vaccine on 25Apr2021, and the second dose is scheduled 16May2021 (correct dosing schedule). Consumer said her son started experiencing symptoms like cold, congestion, headache and scratchy throat on 02May2021 and her son tested positive today 05May2021. Consumer wanted to know if we recommend getting her son's second dose as scheduled. Were any unaddressed medical questions referred or forwarded to Medical Information; Yes. The outcome of events was unknown.  No follow-up attempts are needed; information about lot/batch number cannot be obtained.
24 hrs p/vax pt noted t100.2 2 episodes head jerky lasting 5-10 seconds; parent also described that seemed to be staring more; had APAP every  5 hrs since immun given; no eye deviation, no extremity movement;tongue movement side to side;
Patient is 13 years old at date of vaccination. She was given Pfizer pediatric dose instead of the regular dose. No adverse rxn reported.
This spontaneous report was received from an approximately 43 year old male patient. The patient did not have drug reactions/allergies. The patient's pertinent medical history included L4/L5/S1 disk injury and methicillin resistant staphylococcal infection (MRSA). Concomitant therapies included SINGULAIR, ALLEGRA, AMBIEN, FLEXERIL, naproxen and vancomycin. On an unknown date in 2014 (reported as about 4 years ago), the patient was vaccinated with PREVNAR 13 (dose, route, lot and expiry date not reported) for the prevention of pneumonia. On an unknown date in 2016 (reported as about 2 years ago), the patient was vaccinated with PNEUMOVAX 23 (dose, unit, route, frequency, expiration date and lot number not specified) for the prevention of pneumonia. On an unknown date in 2017 (reported as an year ago), the patient experienced methicillin resistant staphylococcal infection. The patient reported that the patient just had his antibodies tested and they came back low. Types 1, 9, 18c, 20, 22 all came back low on unspecified date. It was reported that the patient received unspecified treatment for the events. The patient reported that in 2018 (reported as recently), he experienced bronchitis on unspecified date and was currently being treated with vancomycin (manufacturer unknown). The outcome of the events bronchitis, antibody test abnormal and staphylococcal infection was reported as not recovered/not resolved. The reporter did not assess the causality of the events with suspect therapies. Product quality complaint was not involved. Upon internal review, the event methicillin resistant staphylococcal infection was determined to be medically significant.
GUILLAIN-BARRE SYNDROME; This spontaneous report received from a patient via a company representative concerned a patient of unspecified age, sex, race and ethnic origin.. The patient's height, and weight were not reported. No past medical history or concurrent conditions were reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin, batch number and expiry were not reported) dose was not reported, 1 total was administered on 01-APR-2021 for prophylactic vaccination. The batch number was not reported. The Company is unable to perform follow-up to request batch/lot numbers. No concomitant medications were reported.  On 01-MAY-2021, 30 days after vaccination, the patient experienced Guillain-Barre Syndrome. The patient reported, this ruined patients life and was not still learning how to walk again. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from Guillain-Barre Syndrome. This report was serious (Other Medically Important Condition).; Sender's Comments: V0: 20220408510-COVID-19 Vaccine Ad26.CoV2.S- GUILLAIN-BARRE SYNDROME. This event(s) is labeled per RSI and is therefore considered potentially related.
Terrible fatigue, every muscle hurts, eye are bloodshot red and burns. Started about 15 ish hours after dose 1.
Severe local reaction around injection site causing redness, swelling upper 2/3 of right arm. Rx Benadryl and ice pack.
N/A  COVID19 (Pfizer) and Varivax was not recorded correctly, patient has 3 accounts with first and  middle name mixed up, patient didn't bring in any immunization record including COVID19 (white) Card. Extra dose of Covid19 and Varivax were given.
Adverse Event: Appendicitis Treatment: Appendectomy Outcome: Symptoms devolved 07/16/21. Presented to ER on 07/17/21, CT confirmed acutely inflammed non-perforated appendicitis. Laparoscopic appendectomy performed 07/17/21. Hospital discharge 07/18/21.
went to bed, got chills for half the night then got hot and was uncomfortable most of the night with stomach ache and little or no sleep
Patient received pfizer vaccine around 1:10-1:20pm 4-14-2021. Patient found passed out but became alert when we called to her. Patient had some red blotches on arms and was given 25mg benedryl and some water. Patient remained in store for about 1 hour and was then driven home by a friend.
11/20/09 7P Rt side face numb, leg spasms or tremors during noc. AM 11/21 speech slurred, Rt hand difficulty writing. Rt leg decreased mobility lean to Rt side w/ walk. Admit to hospital. (11/2 to 11/24) 12/3/09 Follow up with doctor, pt question GBS. States "PA said no because there was no protein in spinal tap" "virus questioned". Right leg mobility f/u appt 3/1/10.
CHILLS STARTING ON 1ST DAY OF VACCINE ADMINISTRATION, NAUSEA, VOMITING, EXTREME FATIGUE
Information has been received from a nurse practitioner concerning a 20 year old female who on 11-Jan-2007 was vaccinated with Gardasil vaccine (yeast), intramuscularly. Concomitant therapy included Allegra and Nuvaring. On 13-Jan-2007 the patient had a "rash from her neck down". The patient was seen in the emergency room and was given Prednisone. At the time of the report, the patient was recovering. The reporter was considering giving the patient Benadryl and Prednisone before the next vaccination with Gardasil vaccine (yeast). The patient's experience was considered to be an other medical event. Additional information has been requested.
Myalgia, Fever, NauseaVomiting, chills, sleeplessness/restlessness (myalgia was specifically stated in back and legs) Narrative: symptoms seem to be worse at night; could not sleep 2nd night
Couldn't walk for hours. Would stumble when he did walk again. Loss of appetite even to this day & fussiness to this day.
Systemic: Dizziness / Lightheadness-Mild, Systemic: Shakiness-Mild, Systemic: Visual Changes/Disturbances-Mild, Systemic: Weakness-Mild, Additional Details: pt became lethargic , dizzy and visual disturbance.  called ems   laid pt on the ground and monitored   vitals ok gave water and snack   pt stayed extra and was ok with parent when left    called later  pt doing well and resting
1 day post injection onset redness, swelling, pain lt wrist & hand.  No local rxn at inject. site.  no previous hx of similar problem, no arthralgia or fever. Symtoms cleared by 18Jun90.
felt achy for 2wk became worse w/muscle aches, denied a fever, denied SOB;viral synd devel secondary;bronchitis;
Tested Positive for COVID-19; Tested Positive for COVID-19; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient. Other Case identifier(s): 22K-163-4365832-00.  An elderly female patient received BNT162b2 (BNT162B2), as dose number unknown (booster), single (Batch/Lot number: unknown) for covid-19 immunisation; coviD-19 vaccine (COVID-19 VACCINE), as dose number unknown, single (Batch/Lot number: unknown). The patient's relevant medical history and concomitant medications were not reported.  The following information was reported: COVID-19 (medically significant), DRUG INEFFECTIVE (medically significant), outcome "unknown" and all described as "Tested Positive for COVID-19". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: Positive.  The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.
Patient is a 89 year old male with PMHx anemia, hypothyroidism, loop recorder, hyperlipidemia, Afib on Xarelto, Hx. of MI., DM, and HLD who presents to ED with a chief complaint of fatigue/weakness for the last 3 weeks. Patient presented to the ED, active inclusion cyst at the inferior border of the R Scapula, which was red and tender which he has been getting drained weekly by Dr. was given keflex, starting on Oct. 4, 2021, which he completed with no without improvement. Patient states he also received the Flu shot on 10/7/21 which he attributed to increasing his fatigue, and at that time began to have episodes of profuse diarrhea. When admitted, patient found to be COVID+-- but throughout his admission, patient was asymptomatic, and stable on RA. Completed Moderna vaccine in April 2021. On admission, labs were notable for: WBC: 5.4 with lymphopenia | Hgb 6.1, and thrombocytopenia | hyponatremia Na 129 | COVID-19 inflammatory markers: D-dimer: 899, CRP: 28.9, LDH: 265, Ferritin: 88. CXR: patchy airspace disease, L > R. UA unremarkable for infection. Patient was given 1L NS bolus, and 2U pRBCS -- which brought resolution to his anemia and hyponatremia. Anticoagulation was held 2/2 requiring blood transfusions and he was placed on IV Protonix BID for suspected GI bleed. Per ID, patient s/p monoclonal antibody infusion, and advised monitoring patient off of antibiotics at this time and continue local wound care (wet to dry dressing, per surgery). In regards to the suspected GI bleed, presenting Hgb level likely 2/2 blood loss from repetitive cyst I/D. Patient had endoscopy in October which revealed gastritis and hemorrhoids. Per GI, if patient's hemoglobin drops again as an outpatient patient will need repeat endoscopy and possible video capsule procedure. Patient admits improvement with fatigue with Hgb values stables, and is hemodynamically stable for discharge. Patient to restart baby aspirin 10/15/2021 and Plavix 10/20/2021 -- patient advised to stop Xarelto use at this time. Patient to follow up with his PCP within on week, and to repeat CBC Friday 10/15 and Monday 10/18, for further analysis.
Pt recvd vax & exp rash & 3 episodes of SOB; sx treated w/DPH;
Soreness, fatigue. rash, hospitalization for 5 weeks, Rare Auto Immune Disease - Dermatomyositis created from vaccine.
Extreme muscle and joint pain, extreme cold chills, fever 100.0, Tylenol and ibuprofen reduced fever. Lasted 24 hours. I had covid on 1/1/21, negative test on 1/14/21
hives, flushed skin, runny nose, tightness in throat w/some diff breathing, anxious, some resp distress but able to speak on phone;BP  130/90;
pt recv vax 20FEB98 & devel a rash starting on both arms & spreading to trunk;some itching but not severe-consulted PMD who told did not think this is related to vax;DPH relieved itching;rash persisted for about;
Lichenoid cutaneous drug eruption.  Skin biopsy confirmed Pityriasis lichenoides et varioliformis acuta triggered by vaccination.  My entire body is still. covered in lesions and scabs and I'm permanently scarred and deformed.
Pt returned to clinic on 12/6/18 with R arm cellulitis, erythematous and size of 6 cm, round. BACTRIM 800-160mg 1 tab BID given to patient for treatment.
Headache, Myalgia, Arthralgia, Diarrhea, Cold sweats, Injection site pain Narrative:
Tested positive for COVID after receiving the vaccine; Based on the current case data, this case has been classified as invalid. This spontaneous case was reported by a health care professional and describes the occurrence of COVID-19 (Tested positive for COVID after receiving the vaccine) in a  patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     The patient's past medical history included No adverse event (Medical History was not provided ).    On an unknown date, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) at an unspecified dose. On an unknown date, the patient experienced COVID-19 (Tested positive for COVID after receiving the vaccine). At the time of the report, COVID-19 (Tested positive for COVID after receiving the vaccine) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown Route) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown Route), the reporter did not provide any causality assessments.   Concomitant medication details were not reported by the reporter. Treatment details was not reported by the reporter.   Reporter did not allow further contact
Had localized reaction that involved a "bloody-looking" bruise about 2" x 2" in circumference.
I gave her first vaccine on Wednesday (1-27). About 9 hours later she had a red, raised rash on the arm of the injection. She stated that this was not specifically at the injection site but on most of the arm. She took Benadryl and the rash resolved in a short time. Then, about 12-13 hours after the vaccine she began vomiting, fever 102 (by thermometer) and chills. She continued these symptoms through 1-28.  On 1-29 she was feeling "queasy"/nausea and "can't eat". She was taking fluids well and reports no symptoms of dehydration and reports that the temp is normal. She was able to perform her normal activities.
A couple of days after vaccine there was redness and itching at injection site. Counseled pt to use hydrocortisone cream and benadryl if desired.  If it continues, patient was instructed to call MD.
Provider ordered an Adult Havrix for the patient. Location does not carry adult Havrix. Nurse obtained pediatric Havrix. Second check  failed to pick up on age of patient and age on Havrix order. Dose administered. As CMA was documenting the administration NDC would not work. This is when CMA discovered that the provider had canceled the Havrix and ordered a Vaqta. RN called and notified patient that the pediatric dose was given and asked if we could have her come back in to have the adult dose administered. Patient was agreeable and scheduled for tomorrow (06/29/2023)
Hair loss; Alopecia areata; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 34 year-old female patient (not pregnant) received bnt162b2 (BNT162B2), administration date 13Apr2021 (Lot number: ew0153) at the age of 34 years as dose 1, single for covid-19 immunisation. Relevant medical history included: "eczema" (unspecified if ongoing); "hypo thyroid" (unspecified if ongoing). Concomitant medication(s) included: TIROSINT. The following information was reported: ALOPECIA (non-serious) with onset May2021, outcome "recovered with sequelae", described as "Hair loss"; ALOPECIA AREATA (non-serious) with onset May2021, outcome "recovered with sequelae", described as "Alopecia areata". The events "hair loss" and "alopecia areata" were evaluated at the physician office visit. Relevant laboratory tests and procedures are available in the appropriate section. Therapeutic measures were taken as a result of alopecia, alopecia areata.  Additional information: The patient receive any other medications within 2 weeks of vaccination includes tiro sent 25 mcg. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient was not diagnosed with COVID-19 prior to vaccination. The patient was not tested for COVID-19 since the vaccination  No follow-up attempts are possible. No further information is expected.
Constant tinnitus, shooting nerve pain in left forearm/hand/fingers, shooting nerve pain in right foot, intermittent numbness in fingers, deep ache and weakness in both hips, radiating pain from hips to thighs, shooting pain in skull,  numbness and pain under skin in left side of face. **The only symptoms currently remaining are intermittent numbness in fingertips (both hands) and constant tinnitus that widens in the evening/early morning.
I started getting a horrible sinus headache and sore throat. After 4 days, I went to Urgent Care, and they gave me Covid Rapid Test - Negative. Then 12/27/2021, I woke up with a terrible headache and sore throat. So, I went to Urgent Care and was given another Rapid Covid Test - Negative. My blood pressure was high and was given Antibiotics for 7 days.
I had a sore arm after the vaccine for 3-4 days. I tested positive for COVID-19 with a home test. I contacted my doctor via telehealth and got a prescription for PAXLOVID. I had a high fever, tired, achy and very fatigued.
23SEP93 severe itching under arms; 24SEp93 rash all over body lasted 1 day;
within 3 minutes of vaccine patient was lightheaded and sat down.  by the time I walked out to check on the patient he was pale, not responsive and eyes were wide and up to the right as if he was going to have a seizure I ran to get the emergency cart and water while the mom braced the child's head.  He was responsive and able to drink by the time I returned and was able to drink water and take 10ml of benadryl.  We walked him back into the clinic room to get blood pressure and removed his shirt that was soaked in sweat.  His reading was 68/29.  I gave him a bottle of water and had the technicians get chips for him while I was getting his reading.  We had dialed 911 in the meantime and the mom wanted the paramedics to come to check him out.  His blood pressure went up to 137/68 , blood sugar was 117 and he was fine by the time the paramedics got there.  He stayed another 30 minutes then left to get food with parents who decided not to take him to the ER.
PT STATED SHE HAS A HEADACHE AND FEELS DIZZY. SHE HAS A METALLIC TASTE IN HER MOUTH. PT ALSO C/O LEG WEAKNESS.  BP 108/66 HR 79 O2 98%  REPEAT BP 112/68 HR 70 O2 97%
Pt immediately felt after getting the vaccine her mouth tingling and a fast heartbeat. Pt did not c/o at vaccine site and as she went home both sensations went away. When she got home the sx appeared again.
Post flu shot fever - in AM - 99.6-99.8 in PM - 100.4-100.8, chills, muscle aches, "scratchy" throat, dry cough, fatigue. Treatment - rest. From Thurs Dec 12 to Tues. Dec 17 2013.
This is a spontaneous report from a contactable nurse via Pfizer sales representative. This nurse reported that a 17-years-old male patient received TRUMENBA, via an unspecified route of administration on an unspecified date at single dose for immunisation. The patient medical history and concomitant medications were not reported. The patient experienced low grade fever non-serious on an unspecified date with outcome of unknown, malaise non-serious on an unspecified date with outcome of unknown, red arm non-serious on an unspecified date with outcome of unknown. The information on the batch number has been requested.
ached really badly; fever about 36 hours; This case was reported by a consumer via interactive digital media and described the occurrence of pain in a patient who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included Shingrix with an associated reaction of pain (received 1st dose on an unknown date in last year and experienced pain and fever, refer link case US2022AMR076844).   On an unknown date, the patient received the 2nd dose of Shingrix. On an unknown date, 36 hrs after receiving Shingrix, the patient experienced pain and fever. Rechallenge with Shingrix was positive. On an unknown date, the outcome of the pain and fever were unknown.   It was unknown if the reporter considered the pain and fever to be related to Shingrix.     Linked case(s) involving the same patient:  US2022AMR076844   Additional Information: GSK Receipt Date: 8-May-2022 Reporter's comments: This case was reported by a consumer via interactive digital media. The patient received 2nd dose in last year 2021 and have not gotten shingles. The patient ached really badly and had a fever about 36 hours after getting the vaccines, but that was it. The patient stated that if you had chickenpox, you could get shingles. The patient decided to take chances with the vaccine. The patient knew people who were not vaccinated, got shingles and still suffer from horrible nerve pain.; Sender's Comments:  US-GLAXOSMITHKLINE-US2022AMR076844:Same reporter