chrisvoncsefalvay/vaers-outcomes huggingface dataset:
The first issue happened the day after receiving the vaccine. I had hemorrhaging, it was a significant bleeding, it looked like I had miscarried. I was freaked out. The next day it happened again, so I called my doctor, and I went in and explained what happened. She did not want to talk about it. She just suggested to get a scan because I might have a fibroids, but I have never had any issues ever with my period. This was so confusing to me. She did a scan and she said I had to go to a center who have stronger machines. I reported to them. I had all these scans and they came back normal. No one wanted to talk about it. I spend a lot of money out of pocket for scans that could not explained what happened. The second issue was in the middle of May. I started experiencing pain in my left arm where I got the injection. I had pain and numbness and tingling. It went all the way to my fingertips. It was pretty intense. I was icing it. I took Advil. I was going back and forth from icing and putting warm compresses. I went to a chiropractor. He did adjustments and massaging. I went every week for adjustments. It was doing a little bit better. On the middle of August all of a sudden the pain came back. It is  constant numbness and tingling. It will not go away. I went in with my doctor at the end of august. She said it might have been some type of nerve situation. They did blood work and it came back normal. I have a referral for a doctor who specialized in that. I have not seen that person yet. I have never had any issues. I have not been in any accidents.
Called to the vaccination floor to assist a patient who was noted to be retching. The patient had just received  the 2nd dose of the vaccine and reported soon after the administration she felt as if she had trouble breathing and without saying or waiting she injected herself with an epi-pen she carries. She reports a H/O POTS, Gaucher's and Mast Cell activation and that at her prior dose had mild symptoms but later revealed after 2 days of getting her first dose she had to inject herself due to respiratory difficulty. The patient decline EMS intervention and transport. She was observed in the POD > 30 mins , over which time her symptoms resolved completely and it was safe to send her home. Her husband will drive her home.  It was recommended that she follow up with her PCP and allergist ASAP.
Pregnant patient had Tdap on 7/6/18. Noted absence of fetal movement on 7/7/18, no fetal movement x 4 days. Sought medical care on 7/10/18 - IUFD confirmed by Ultrasound. Denies travel, recent illness, no history of trauma. States the only thing that was different was receipt of a vaccine the day prior to the change/lack of fetal movement.
Initial information received on 06-Nov-2018 regarding an unsolicited valid non-serious case received from an other health professional. This case is linked to case 2018SA312352 (Same reporter). This case involves a 16 years old female patient who received 0.5ml of vaccine FLUZONE QUADRIVALENT (batch number: UT6258MA, expiry date: 30-Jun-2019) (dose in series and site of administration were not reported) via intramuscular route on 05-Nov-2018 which was frozen. The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided. Concomitant medication was none. Reported as No other medication or vaccines were given. It was a case of potential medication error due to incorrect product storage. It was reported as, on 11/5/2018, staff person attempted to give a 0.5 ml dose of FLUZONE QUAD IM to patient, but the plunger wouldn't depress because the "vaccine was frozen". No other medication or vaccines were given except a second, unfrozen 0.5ml IM injection of FLUZONE QUAD, in the right arm. The frozen syringe was thrown away. It was not reported that if any adverse reaction was experienced or not. This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holder's compliance with the requirements set out in Directive 2001/83/EC and Module VI of the Good Pharmacovigilance Practices. The classification as a medical error is in no way intended, nor should it be interpreted or construed as an allegation or claim made by the marketing authorization holder that any third party has contributed to or is to be held liable for the occurrence of this medication error. List of documents held by sender: none.
Patient has severe inflammation. She went to her PCP and he gave her Mobic. Her condition was worsening. She had no use of her arm. Mobic didn't help and she was referred to an orthopedist. He said that she has SIRVA (shoulder injury related to vaccine administration). This injury is commonly seen now. The orthopedist gave her a cortisone shot, after that she had to ice it, and she must get physical therapy for 1 year. On top of this the orthopedist said that she never received the flu shot.
Patient developed pruritic urticaria to bilateral forearms and upper arms 5 minutes after receiving booster dose.  First noticed on ipsilateral side of injection.  He did not have any oral involvement, respiratory distress. Gave 25mg Benadryl PO. Observed for 30 minutes in clinic and remained stable.  Approx 20 hours later he was stable and hives were resolving.
Developed chills in the evening and over night the first day. Second day fever of 99.7, took ibuprofen 400mg but little relief. Third day 600mg, got some relief but about 6 hours later wearing off. Too another 600mg and plan to take again at bedtime.
Information has been received from a lawyer regarding a case in litigation concerning a female patient (age unknown). The patient's medical history, concurrent conditions and concomitant medication use were not provided. On or about 03-JUN-2008, the patient was vaccinated with ZOSTAVAX, (lot# and route unknown) as recommended for routine adult health maintenance and for the prevention of shingles. The vaccine did not prevent shingles as intended, and the patient subsequently contracted a persistent strain of herpes zoster. On or about 15-JUN-2016, the patient was treated by a physician for the onset of a severe vesicular rash, which was diagnosed as herpes zoster, or shingles. As a direct and proximate result of the ZOSTAVAX, and/or despite receiving ZOSTAVAX for long-term prevention of shingles, the patient suffered painful injuries and damages, and required extensive medical care and treatment. As a further proximate result, the patient has suffered and will continue to suffer significant medical expenses, and pain and suffering, and other damages. Additional information has been requested.
Patient took 50mg Benadryl prior to injection at 1300. She also took Xanax  at 1000 prior to injection. Immediately following the vaccination, patient reported onset of slight headache and tingling lips. No SOB. O2 100%, HR 80.
0.5 cm x 5.5 cm area of pink. 3.5 cm x 3.5 cm area of redness R induration.
This spontaneous report as received from a medical assistant refers to an unspecified number of patients of unknown age and gender. The patients' medical history, concurrent conditions and concomitant therapies were not reported. On unknown dates the patients were vaccinated with improperly stored GARDASIL (lot # L020162, expiration date 23-JUL-2017; Lot# was reported as L032181, expiration date was reported as 25-AUG-2017; Lot# was reported as L043702, expiration date was reported as 03-NOV-2017; route and dose were not reported). The vaccines were exposed to 33 F for 3 hours and 49 F for 50 minutes without previous excursion. The issue was due to data logger. No symptoms were reported. This is one the several reports from the same reporter. Additional information has been requested.
Shivering overnight, sore arm, and sore armpit for 2 days.
I woke up in the middle of the night itching with hives all over my body, on 11-22-01 went to my own family doctor on 11-22-01. Said he didn't know what caused the hives.
Arm sore at injection site. Nurse noted red area approx. 4x4" diameter with knot 1.5" diameter.
SM developed redness, swelling, pain, induration at site of ANTHRAX injection.  Symptoms resolved within 72 hrs.  Symptoms: Erythema, Edema @ injection site 30-50 mm, Swelling, Pain.
Child experienced redness and swelling in entire upper thigh starting 3/11/03 at around 6 p.m. Child was seen by MD and placed on antibiotics.
Treatment of COVID-19; Treatment of COVID-19; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 53-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 26Sep2021 as dose 3 (booster), single (Batch/Lot number: unknown) at the age of 53 years 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 included: "PFO closure with Gore Cardioform 30mm" (unspecified if ongoing), notes: PFO closure with Gore Cardioform 30mm. The patient's concomitant medications were not reported. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant) all with onset Aug2022, outcome "unknown" and all described as "Treatment of COVID-19". Therapeutic measures were taken as a result of drug ineffective, covid-19.  Additional Information- Patient received antiviral drug Paxlovid on 07Aug2022 till 13Aug2022 for Covid-19 treatment. No other medication patient took in 2 weeks. Patient had no known allergies.   No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
bilateral DVT; This is a spontaneous report from a contactable physician. An 84-year-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection), dose 2 intramuscular, administered in Arm Right on 25Mar2021 (at the age of 84-years-old) (Batch/Lot Number: EP6955) as SINGLE DOSE for covid-19 immunisation. Medical history included CKD, Allergic Rhinitis, basal cell carcinoma, vertigo, dupuytren's contracture, Gerd, hypothyroidism, hypertension, osteoarthritis, osteoporosis, prediabetic, palpitations, sleep apnea, seizures, anxiety, Allergies to medications, food, or other products: BACITRACIN, LATEX, MORPHINE, POLYSPORIN, ADHESIVE TAPE. Concomitant medication(s) included azelastine (AZELASTINE); enalapril (ENALAPRIL); famotidine (FAMOTIDINE); fluoxetine (FLUOXETINE); fluticasone (FLUTICASONE); ipratropium (IPRATROPIUM); levetiracetam; levothyroxine; zonisamide; all taken for unspecified indications, start and stop dates were not reported. The Patient was not diagnosed with Covid-19 prior to vaccination. The patient received first dose of BNT162B2 (lot number: EN6198) via intramuscular in right arm for COVID-19 immunization on 26Feb2021 at the age of 84-years-old. On 29Mar2021, the patient experienced bilateral dvt (life threatening). Therapeutic measures were taken as a result of bilateral dvt: ELIQUIS. The outcome of the event was recovering. Since the vaccination, the patient has not been tested for COVID-19.  Information on Lot/Batch number is available.; Sender's Comments: There is not a reasonable possibility that event DVT is related to BNT162B2.  This elderly patient had multiple underlying diseases.  The event is more likely intercurrent medical condition. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to Regulatory Authorities, Ethics Committees and Investigators, as appropriate.
pt recv vax; devel severe localized rxn w/ boggy edema; sx resolving gradually;
Received Pfizer COVID vaccine  around 1550 in the left arm. A few     minutes after receiving the vaccine, she began to feel short of breath,     with associated coughing, followed by an episode of nausea and emesis.     She received PO and IM Benadryl which resulted in improvement in her     breathing and coughing.  Transported to ER by EMS.  She was given prednisone for 5 days with prn H2 blockers and H1 blockers.
Swelling of lymph glands, head aches, swollen throat, pain in testicles, loss of appetite, tiredness, low energy.
Jan. 28, 2010 Slow-onset reaction left arm pain after given injection. Right leg & left leg burn and feel heavy. Loss of balance. Dropping things. Have had 3 falls in last year. Tired all the time, no energy.
Abd. pain, (+) Stool Guaiac, screaming with eating. Difficult to have BM. Intussusception - admitted 1/11/09 after reduction with air enema. (+) recurrence 1/13/09 with repeat air enema reduction, then surgery.  1/21/09-operative report received for DOS 1/15/09-presented with C/O ileocolic intussusception.  Exploratory laparotomy. Findings: ileocolic intussusception secondary to hypertrophied Peyer's patches in terminal ilieum. The intussusception reduced manually. Appendectomy. Resection Meckel diverticulum. 2/2/09-records received for DOS 1/11-1/17/09-DC DX: Inutssusception. Intussusception reduced on 1/11/09 by air contrast enema after bloody, jelly stool. Presented on 1/13/09 with C/O emesis, increased fussiness, abdominal irritation. US showed recurrence of intussusception.  2/2/09-records received for DOS 1/11-1/17/09-DC DX: Inutssusception. Intussusception reduced on 1/11/09 by air contrast enema after bloody, jelly stool. Presented on 1/13/09 with C/O emesis, increased fussiness, abdominal irritation.  This case was reported by a physician via a sales representative and described the occurrence of intussusception in a 4-month-old subject of unspecified gender who was vaccinated with ROTARIX (GlaxoSmithKline). On an unspecified date the subject received 1st dose of ROTARIX (unknown). One month after vaccination with ROTARIX, the subject experienced intussusception. The subject required surgery and the adverse event resolved. The physician considered the event was clinically significant (or requiring intervention). The physician considered the events was possibly related to vaccination with ROTARIX. Follow-up information received on 26 February 2009 indicated that the subject was a 4 month old female. She received oral ROTARIX on 18 November 2008. Almost two months later, on 07 January 2009, symptoms began. A diagnosis of intussusception was made on 10 January 2009. The subject underwent surgical reduction with no resection on 15 January 2009. The event resolved on 17 January 2009. In addition to intervention, this case was considered to be serious as the event was life threatening and the subject was hospitalized. In the physician's opinion, the events were possibly related to treatment with ROTARIX.
per patient "12/30 9:30 am(approximate 1 hour after Moderna COVID19 vaccine) was home became woozy passed out 2 mins recovered in 5-10 mins. 11:30 am fixing lunch no warning passed out hit floor out 1-2 hours not responding BP 60/40 has POTS and family treated with IVF and pickle juice she was out of it in bed until 6pm. Did no take am meds prior to 08:30 vaccine but on Colanar 4mg bid, Cymbalta 40mg qd, Omeprazole 20 mg qd, Lisinopril 20mg qd, Benadril 50mg IV via port bid, Motegrity 2mg qd, Ducolox 30 qd,  Senna 2 tabs qd, Zanaflex 4mg tid prn, Clonazepan 1mg q12 hour prn, Ibuprophen 800mg prn.
For all three shots (the 2 initial ones and the booster), I developed Oral Erythema Multiforme within days of receiving the shot. This meant gum and mouth lesions, bleeding gums, pain while eating/drinking, and a host of other oral problems. Each time, I had symptoms for weeks. My treatment was going on dexamethasone rinse and clobetsol gel for weeks until symptoms resolved.
Local injection site reaction approximately 11.5 cm x 10 cm oval shaped, erythematous urticarial lesion that is warm to touch. Required PO and topical steroids.
About 5 hrs after vaccine severe arm pain, fever(102),  bad headache and chills.
Information has been received from a registered nurse concerning a 16 year old female with no previous medical history reported and an allergic reaction to bee sting who on 19-JUN-1997 was vaccinated with the first dose of VARIVAX (Oka/Merck) 0.5 mL subcutaneously in the left arm. On 18-SEP-2008, the patient was vaccinated with the second dose of VARIVAX (Oka/Merck) (Lot #0956X). There was no concomitant medication. On 18-SEP-2008, the patient developed an immediate injection site reaction, an itchy, red, warm area at the injection site described as a large wheal. The patient was kept in the office for 20 minutes and administered BENADRYL. The patient was recovering when they left the office and has not contacted the office 24 hours after the vaccination. There was no product quality complaint. Additional information is expected.
Information has been received from a physician referring to a female patient of unknown age. The patient's concurrent condition, medical history and concomitant therapy were not provided. On an unknown date (reported as some time ago), the patient was vaccinated with GARDASIL (dose, route, lot number and expiration date were unknown). On an unspecified date, the patient had a sexual transmitted disease (STD) test (unspecified reason) which showed "her Herpes simplex virus (HSV) IgG was positive". The outcome of the event was unknown. Causality was not reported No product quality complaint (PQC) issue was involved. Additional information has been requested.
Onset of autoimmune flare that was the most severe I've ever experienced and included inflammatory bowel flare with bleeding, eczema flare that continues to be uncontrolled 8 months later, pain in all of my joints that is ongoing and a new development on January 10 of autoimmune anterior uveitis (inflammation of the anterior surface of the eye) that led to significant retinal scarring in both eyes and permanent vision loss. Also uncontrolled hashimotos requiring multiple labs and changes to dosing of thyroid medications
Headache, vomiting, swollen and painful bilateral armpit lymph nodes, back/spine pain, lethargy. Arm pain in arm that received injection. Extremely tired. Loss of appetite. Most symptoms lasted approximately 12 hours. Swollen lymph nodes lasted approximately 4 days. Arm pain lasted approximately 4 days.
Narrative:  Two weeks after second dose, patient was admitted to hospital February 8th, 2022 with CPK greater than 10,000 and reports of rash, myositis, and concerns for rhabdo. Discharged to CLC for rehab on March 28th, 2022. Discharged from CLC on 10mg of Prednisone daily and Methotrexate 10mg weekly for ongoing for dermatomyositis.
Itching immediately after.  Below shot redness, swelling, heat. Redness extended down about 4 inches wide and 4 inches long. Pain. Dizziness.  When swallowing it felt like there was a stick in my throat.
Pain and swelling at injection site, pain traveled to joints in arm where vaccine was given.. mild headaches, gone now, low grade fever. Avg of 100 still present, pain in muscles subsiding, still sore
G62.9 PERIPHERAL NEUROPATHY 3/1/2023 ATRIAL FIBRILLATION, PERMANENT I21.A1 TYPE 2 MI 4/20/2023 ATRIAL FIBRILLATION, PERMANENT G62.9 PERIPHERAL NEUROPATHY 3/1/2023 ATRIAL FIBRILLATION, PERMANENT I21.A1 TYPE 2 MI 4/20/2023 ATRIAL FIBRILLATION, PERMANENT
Headache, Diarrhea, NauseaVomiting, sore left arm, fatique, chills Narrative:
Sharp pain on left side of chest, numbness and tingling down left arm from neck to fingertips, heart fluttering, muscle fatigue, weakness, body aches, fever, and fatigue
pt recv vax 430PM 19MAY96 & 5PM had fever of 100, chills, nausea, h/a, & dizziness for about 2hr;felt very fatigued rest of day;slept all next day & felt better by evening;pt is recovered @ this time
NAUSEA; TIREDNESS; This spontaneous report received from a patient concerned a female of unspecified age. The patient's weight, height, and medical history were not reported.  The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 1805025, expiry: UNKNOWN) dose was not reported, administered on 17-MAR-2021 for prophylactic vaccination. No concomitant medications were reported.  On 17-MAR-2021, the subject experienced nausea. On 17-MAR-2021, the subject experienced tiredness. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from nausea, and tiredness on 2021. This report was non-serious.
This spontaneous report was received from a nurse regarding unspecified patients of unknown age and gender. The patients' pertinent medical histories, drug reactions or allergies and concomitant therapies were not reported. On unspecified dates, the patients were vaccinated with improperly stored doses (2 doses) of ROTATEQ (lot# L037574 with an expiry date of 01-JUL-2017) (dosing details not known). The administered doses experienced a temperature excursion of 0.5 degree Celsius for 1 hour and 32 minutes. The vaccine underwent previous temperature excursions of 1 degree Celsius for 7 hours and 34 minutes. The call was because of a "data logger". No adverse effects were reported. There was no product quality complaint (PQC) involved. This is one of two reports received from the same reporter. Additional information has been requested.
PATIENT SOUGHT TREATMENT FOR AN ACUTE FLARE-UP OF HER RA SYMPTOMS, WHICH SHE CLAIMS BEGAN ALMOST IMMEDIATELY AFTER HER VACCINATION. MD PRESCRIBED A COURSE OF PREDNISONE. PATIENT HAS BEEN UNABLE TO COMPLETE HER 2-3 MILES OF WALKING TO CONTROL HER RA SYMPTOMS SINCE RECEIVING HER VACCINE. PATIENT DOES REPORT THAT SHE IS NOW RETURNING TO NORMAL AS OF TODAYS DATE, 12/16/2019.
angioedema; A spontaneous report was received from other healthcare professional concerning forty-two-years-old female patient who received Moderna's COVID-19 vaccine (mRNA-1273) and experienced angioedema.  The patient's medical history was not provided. No relevant concomitant medications were reported.  The patient received the first of the two planned doses of mRNA-1273 on 30-DEC-2020 (Batch# 026L20A) intramuscularly for prophylaxis of COVID-19 infection. On an unknown date, approximately one week after receiving the mRNA-1273 vaccine, the patient received Botox and filler injections. Approximately 12 hours later, the patient experienced angioedema.  Treatment details included prednisone 40 mg, diphenhydramine 50 mg and famotidine.  Action taken with mRNA-1273 in response to the event was not applicable.  The outcome of the event was resolved.  The assessment was not provided for the event.; Reporter's Comments: Based on the current available information and temporal association between the use of the product and the start date of the event, a causal relationship cannot be excluded.
Moderna Bivalent 10 mcg dose given instead of bivalent 25 mcg dose
This spontaneous report was received from a Licensed Practical Nurse (LPN) referring a patient of unknown age and gender. The patient's medical history and concurrent conditions were not reported. On an unknown date, the patient was vaccinated with an expired dose of PNEUMOVAX 23, with lot # K005402, expiration date 07-NOV-2015, (dose, frequency and route of administration were not reported). No other concomitant therapies were reported. A Product Quality Complaint (PQC) was filled because the reporter stated that the administered dose of PNEUMOVAX 23 was from a 10 pack with a different (current) expiration date. No adverse effects were reported. Additional information has been requested.
POSITIVE COVID TEST, MYALGIAS, FEVER, BLOOD CULTURE POSITIVE FOR MSSA