chrisvoncsefalvay/vaers-outcomes huggingface dataset:
IMMUNE THROMBOCYTOPENIC PURPURA (ITP); This solicited report received from a physician concerned a 56 year old male. The patient's height, and weight were not reported. No past medical history or concurrent conditions were reported. The patient initiated treatment with covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: Unknown and expiry: Unknown) dose, start therapy date were not reported, 1 total administered for prophylactic vaccination (Dose number in series 1). 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 an unspecified date, approximately 16 days post vaccine, the patient was diagnosed with immune thrombocytopenic purpura (ITP) and was treated with immunoglobulin human normal (Octagam), platelets, and dexamethasone (Decadron). The patient was hospitalized (date unspecified) and number of days hospitalization was not reported (Dose number in series 1). The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from immune thrombocytopenic purpura (ITP). The reporter considered the causality between covid-19 vaccine ad26.cov2.s, and immune thrombocytopenic purpura (ITP) as related. The company causality between covid-19 vaccine ad26.cov2.s, and immune thrombocytopenic purpura (ITP) was related. This report was serious (Hospitalization Caused / Prolonged). This case, from the same reporter is linked to 20220114526.; Sender's Comments: V0 : 20220114483-COVID-19 VACCINE AD26.COV2.S-immune thrombocytopenic purpura. This event(s) is labeled per RSI and is therefore considered potentially related.
This case was reported by a nurse to a sales rep and described the occurrence of injection site reaction in a teenager of unspecified gender who was vaccinated with tetanus toxoid, reduced diphtheria toxoid and acellular pertussis vaccine, adsorbed (Boostrix) for prophylaxis. On an unspecified date on or before 16Feb06, the subject inadvertently received a dose of Boostrix (dose number and lot number not provided) via the SC route of injection. The recommended route of injection of Boostrix is IM. At an unspecified time following the admin of Boostrix, on an unspecified date on or before 16Feb06, the subject experienced injection site reaction. The outcome of the events was not reported.
2 days after, complaining of chills, nausea, no appetite and significant weight loss of 10#.
pt recvd vax & exp muscle & joint pain throughout entire body exp neck & back & sl nausea; 11JUN93 devel a sl temp;
pt stated that 3hr p/vax devel t103, body aches, chills, vomiting, sore throat;pt was seen in office 16hr p/vax initiated temp was 101.2, vomiting stopped;still c/o nausea, runny nose, body aches;
redness; rash; swollen; Baby is crying a lot; Localized reaction; Initial information received on 15-May-2020 regarding an unsolicited valid non-serious case received from a consumer/non-hcp.  This case involves an infant patient who experienced redness (erythema), rash (rash), swollen (swelling), baby is crying a lot (crying) and localized reaction (local reaction), while he/she received vaccine DIPHTHERIA/TETANUS/5 HYBRID AC PERTUSSIS/IPV(MRC5)/HIB(PRP/T) VACCINE [PENTACEL].  The patient's medical history, past medical treatment(s), vaccination(s) and family history were not provided.    On an unknown date, the patient received a dose of DIPHTHERIA/TETANUS/5 HYBRID AC PERTUSSIS/IPV(MRC5)/HIB(PRP/T) VACCINE (lot UJ190AAA expiry date not reported) via unknown route in unknown administration site for prophylactic vaccination.  On an unknown date, the patient developed redness (erythema), rash (rash), swollen (swelling), baby is crying a lot (crying) and localized reaction (local reaction) (unknown latency) following the administration of DIPHTHERIA/TETANUS/5 HYBRID AC PERTUSSIS/IPV(MRC5)/HIB(PRP/T) VACCINE.  No relevant laboratory tests were reported.  Final diagnosis was local reaction, crying, swelling, rash and erythema.    It was not reported if the patient received a corrective treatment.  The patient outcome was reported unknown for all the events.
Redness, induration, heat swelling RUA.  Moist heat applied.  Treated with IV Doxycycline and showed improvement.
Information has been received from a physician concerning a male who is over 65 yrs old who was vaccinated with pneumococcal 23v polysaccharide vaccine IM several years ago. The physician reported that the pt was given two doses of pneumococcal 23v polysaccharide vaccine within a three year time frame. The pt experienced severe illness, fever and malaise. This occurred several years ago. Unspecified medical attention was sought. Additional information has been requested.
This spontaneous report was received from a registered pharmacist reporting on a patient of unknown age or gender. No information was provided regarding the patient's pertinent medical history, concomitant medications, drug reactions or allergies. Approximately in 2015, reported as two years ago, the patient was vaccinated with the first dose of ZOSTAVAX injection (exact dose, route of administration, lot# and expiry date were not reported). On 24-MAY-2017, the patient was inadvertently vaccinated with the second dose of ZOSTAVAX injection, subcutaneously (lot# M0338863, expiry date 12-DEC-2017; exact dose was not reported). The pharmacist discovered that the patient had already been vaccinated two years before only after the second dose of the vaccine was administered. No adverse effects were reported. There was no product quality complaint involved. Additional information has been requested.
patient became lightheaded, diaphoretic, dizzy and hypotensive about 5 minutes after receiving her vaccine
Left upper arm swollen, warm to touch, mildly tender. Tx amoxil 250mg chewable #40 1 1/2 BID.
Patient tested positive for COVID-19 on 8/23/2021 and was hospitalized. The patient had been having a cough for over a week. He states that he feels tired and fatigue and is worse when he ambulates.  The patient was hospitalized for about 8 days until he expired on 9/1/2021 due to cardiac disturbances.
Patient complained of shortness of breath (history of COPD) - resolved with albuterol. BP 177/100 (pulse 72); after observation, went down to 140/90 (pulse 72).
At approximately 9:00 pm, patient began to have itching on arms and legs.  She contacted me at 9:57 pm and I advised her to take Benadryl.  At 10:58 pm, she contacted me stating that she was beginning to have difficulty breathing.  I told her to immediately go to the nearest emergency room, take her immunization card with her.  at about 12:15 am the next morning, the hospital gave her Epinephrine and Benadryl via IV.  She was released from hospital at 2:30 am
Pt had vaccination and returned to lobby for 15 minute waiting period. While seated in lobby, became stiff and fell from his chair to the floor. Nurse responded, pt's jaw was clamped shut and pt appeared to be seizing. VS within normal limits, and pt returned to alert state within 2 minutes. EMS responded several minutes later and evaluated pt, who denied need for transport to hospital ER
This spontaneous report as received from a register nurse refers to a 6 months infant, of unknown gender. Medical history and concurrent conditions were not reported. On 17-MAR-2014, the patient was vaccinated with third dose of ROTATEQ, lot #J008735; expiration date: 24-MAR-2015 (dose and strength were not reported. Secondary and concomitant therapies were not reported. Nurse called and stated that improperly stored ROTATEQ was administered to patient. No adverse effects reported. The nurse reported that vaccine dose received by patient was a vaccine improperly stored as follows: On 13-JAN-2014, ROTATEQ was stored outside of recommended temperatures for 2 hours (2 pm - 4 pm) the temperature recorded was 50 degrees F. On 18-JAN-2014, ROTATEQ was stored outside of recommended temperatures for 2 hours (2 pm - 4 pm) the temperature recorded was 49.1 degrees F. On 10-FEB-2014, ROTATEQ was stored outside of recommended temperatures for 6 hours (12 pm - 6 pm) the temperature recorded was 51.8 degrees F. On 16-FEB-2014, ROTATEQ was stored outside of recommended temperatures for 5 hours (12 pm - 5 pm) the temperature recorded was 51.8 degrees F. On 22-FEB-2014, ROTATEQ was stored outside of recommended temperatures for 4 hours (2 pm - 6 pm) the temperature recorded was 52.7 degrees F. On 09-MAR-2014, ROTATEQ was stored outside of recommended temperatures for 2 hours (12 pm - 10 pm) the temperature recorded was 55.4 degrees F. On 15-MAR-2014, ROTATEQ was stored outside of recommended temperatures for 6 hours (8 am - 2 pm) the temperature recorded was 50 degrees F. On 16-MAR-2014, ROTATEQ was stored outside of recommended temperatures for 20 hours (2 am - 10 pm) the temperature recorded was 64.4 degrees F. On 17-MAR-2014, ROTATEQ the temperature reading on the morning was 64.8 degrees F. The total of hours stored outside of recommended temperatures was 55 hours. This is one of several reports from the same reporter. Additional information has been requested.
Initial information received on 06-Nov-2018 regarding an unsolicited valid non-serious case received from an other health professional (Infection Control). This case involves a patient of unknown demographics who received an expired dose of vaccine FLUZONE QUADRIVALENT (batch number: UT5934NA, expiry date: 30-Jun-2018) (dose, dose in series, route and site of administration were not reported) on an unknown date which was from last year's. The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided. Concomitant medication was not reported. It was case of actual medication error due to Expired vaccine used. It was not reported that if any adverse event was experienced. 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.
Numbness in my thumbs and forefingers on both hands; This spontaneous case was reported by a consumer and describes the occurrence of HYPOAESTHESIA (Numbness in my thumbs and forefingers on both hands) in a  patient of an unknown age and gender 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 second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced HYPOAESTHESIA (Numbness in my thumbs and forefingers on both hands). At the time of the report, HYPOAESTHESIA (Numbness in my thumbs and forefingers on both hands) outcome was unknown.            Patient took second dose of the vaccine on 08/Jun  No concomitant medications were reported  No treatment medications were reported   Reporter did not allow further contact
Severe lower back pain that began shortly after 1st dose and became significantly worse after the second dose.   My menstrual cycle has also been irregular following the vaccine. I had intense cramping and heavy bleeding that last over a week.
A physician reported that a 2 month old male received his first dose of Prevnar on 21 FEB 2002 and developed sleepiness later that day which lasted for 48 hours. No concomitant vaccines were administered.
So umm I been I had another adverse event but I had been on birth control for several years to prevent my period due to my seizures and as soon as I had my second vaccine I woke up in the middle of the night to having a heavy mensural cycle and since I have been having them several times a month and very heavily ever since then. I am not on a regular schedule like a healthy period would be, sometimes it is none stop. The doctor stated that many of her patients are having the same problem and studies were just started on this and that there is no conclusion to this but what she did was put a Nexplanon birth control insertion in my arm to stop my cycle and that has not worked. It is still happening.
Hives appeared 48 hours after vaccination. They continued to increase in intensity daily for 4 days, despite taking antihistamines. Doctor prescribed prednisone on day 5 of symptoms.
Pt was given MMR in L thigh. approx 5 min after injection pt came back with small hives on cheeks, ears, shoulder blades and injection site. 1/2 tsp BENADRYL given.
Itchiness in tongue and throat. Benadril 25 mg Po/ solumedrol 125mg IV Home: Medrol 4mg PO/ Atorax 25mg.
This initial spontaneous report was received from a lawyer regarding a case in litigation and refers to a female patient of unknown age. No information was provided regarding concomitant medications, concurrent conditions or medical history. On or about 11-MAR-2015, the patient was inoculated with ZOSTAVAX at a medical office for routine adult health maintenance for the prevention of shingles (dose, route, and lot # not provided). The vaccine did not prevent shingles as intended and the patient subsequently contracted a persistent strain of herpes zoster, also known as shingles and other complications. On or about 22-AUG-2016, the patient was treated at the same medical office for a blistering vesicular outbreak that was diagnosed as severe shingles. She was prescribed valacyclovir for management of her painful symptoms and chronic pain. As a direct and proximate result of the ZOSTAVAX vaccine, 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. The outcome of the events was unknown.  Causality assessment was related. Additional information has been requested.
After having pain along base of shoulder blade, got a red rash on arm and across left breast. Itchy and painful.
Headache, nerve pain, muscle pain, joint pain, fatigue - ongoing for several days - partial resolvement at time of reporting
generalized erythematous rash developing the day after vaccine. No itching, hives, or airway compromise
I had been out of town at a wedding. When I got back home, I tested before going to work just to make sure that I had not gotten COVID-19, the home COVID-19 test came back negative. A few days later a friend called to say she was positive, I decided I would test again, this time it did come back positive. I stayed in quarantine for ten days, my symptoms were very mild and I was feeling great.
Palms and soles of feet itch, no rash, blister, or blemishes on hands or feet; This is a spontaneous report from a contactable consumer. This 34-year-old female consumer (patient) reported.  A 34-years-old non-pregnant female patient (not pregnant at the time of vaccination) received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, Lot Number: FD8448), via an unspecified route of administration, administered in Right arm on 18Aug2021 08:30 (34-years-old at the time of vaccination) as dose 1, single for covid-19 immunisation. The patient medical history included Environmental allergies, PCOS (polycystic ovaries), Von Wille brands from an unknown date and unknown if ongoing. The patient's concomitant medications in two weeks included Multivitamin. The patient had not taken other vaccine in four weeks. The patient had not been tested for covid prior vaccination. The patient had not been tested for covid post vaccination. On 19Aug2021 at 12 pm, the patient experienced palms and soles of feet itch, no rash, blister, or blemishes on hands or feet. The patient not received any treatment. The outcome of event was not recovered.  Follow-up attempts are completed. No further information is expected.
02/07/2023 I woke up with a fever, sinus congestion, coughing, sneezing exhaustion and body ache. I reached out to my doctor and was prescribed PAXLOVID. Symptoms lasted approx. 7 days.
COVID-19; COVID-19; Illness; Toe injury; Stomach ache; This is a solicited report received from marketing program on the information received by Pfizer (MFR Control No. # 21K-163-4039839-00) via a consumer(patient) or hcp. A 51-year-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection with Batch/Lot Number: Not reported), via intramuscular route on 20Jul2021 as DOSE 1 (at the age of 51-year-old), DOSE 2, SINGLE and intramuscular on 27Aug2021 (Batch/Lot number was not reported) SINGLE for COVID-19 immunization and the patient also received adalimumab (HUMIRA, Batch/Lot number was not reported), subcutaneous, at Citrate Free for moderate to severe rheumatoid arthritis. The patient medical history and concomitant medications were not reported. It was unknown if patient was enrolled in a COVID-19 Vaccine Trial. The patient experienced COVID-19, illness, toe injury and stomach-ache. The patient underwent lab tests and procedures which included body temperature: unknown. The reporter's causality for the events of illness, injured small toe, had covid-19 after getting covid vaccine and stomach ache with HUMIRA(adalimumab) was no reasonable possibility. The reporter's causality for the events of illness, injured small toe, had covid-19 after getting covid vaccine and stomach ache with BNT162b2 was possible. Patient underwent lab test The event outcome for toe injury and illness was reported as recovered. The events outcome for COVID-19 and stomach-ache was reported as unknown. The lot number for the vaccine, [BNT162B2], was not provided and will be requested during follow up.; Sender's Comments: Based on known drug safety profile, there is reasonable possibility of causal association between the events Drug ineffective, covid-19, Illness, limb injury, and abdominal pain upper and BNT162B2.
Patient was transferred to hospital from another hospital due to need for repair of right femur fracture. Outlying facility did not feel comfortable performing surgery due to patient testing positive for covid.  Patient had surgery for repair on 6-25. Patient tested positive for covid on 6-24.
Right forearm, bicep, and shoulder pain, weakness, tingling/numb fingers, tendinitis, cubital tunnel syndrome
Pt devel fine red rash w/in approx 10mins p/inject; inject site clear; no erythema; rash faded but still present 1 hr later; no edema, no resp distress noted; no high pitched crying; MD ordered to observe;
Light tension headache behind eyes, very sleepy, aches at joints (knees, lower back, elbows.
Fever; Chills; Aches; Red patches on her back, like a rash; Red patches on her back, like a rash; This is a spontaneous report from a contactable consumer (patient). A 77-year-old female patient received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Solution for injection, Lot Number: unknown) via an unspecified route of administration on 10Feb2021 at 10:30 AM as dose 1, single for COVID-19 immunisation. The patient states she received the first dose of the Pfizer COVID vaccine yesterday morning at 10:30 am and on an unspecified date in 2021, woke up in the middle of the night with fever, chills, and aches. The patient stated that after receiving the Covid 19 vaccine on an unspecified date in 2021, she noticed red patches on her back, like a rash. The report was non serious. Outcome of the events was unknown.  Information on the batch/lot number has been requested. Follow-up attempts are completed. No further information is expected.
Tightening of throat, making swallowing and mouth breathing very difficult; throat pain starting at 7 pm and continuing through the night, with a post-nasal drip type of cough (especially when reclining). Severe headache starting around 9:30 PM and increasing during the night. Hallucinations accompanying high fever, chills, and headache between 11 PM and 5 AM. Weakness, lightheadedness, and blood pressure of 83/65 around 8:30 AM on 10/21. Slight throat soreness continuing during the day 10/21/10. Eyes oozing, crusting, and puffy during the night 10/20-21/10.
Approximately 90 minutes post vaccination patient reported vomiting and diarrhea as well as lightheadedness and dizziness. Patient sought treatment at ER. Given nausea medication. Connection to vaccine not determined.
Had 2nd covid vaccination Friday, May 7 in right arm. Saturday, May 8 in the afternoon started having pain on the left side of my chest with deep breaths, continued to get worse. Sunday, May 9th went to Emergency Room to have diagnosed (pleurisy).  I have never had pleurisy before.
Right arm pain, Fatigue, Body Aches, My Rheumatoid Arthritis Symptoms which had been in remission started again: Terrible Weakness and Pain in both hands and arms, difficulty raising arms over head, joint pain all over body, swollen joints especially knuckles in hands, unable to grip with hands, leg pain, knee joint/ankle pain, increased back and neck pain - Pain symptoms worse in the morning w  extreme fatigue in mid afternoon and evening.  After a few weeks I went and got Prednisone from doctor, this helped alleviate some of the pain and symptoms.  Still having pain - not back to where I was before I got the 1st Moderna Shot on July 13, 2021
a few anaphylactic reactions; many new food allergies post covid vaccines; This is a spontaneous report received from a non-contactable reporter(s) (Consumer or other non HCP), Program ID. The reporter is the parent.  A 24-year-old female patient received BNT162b2 (BNT162B2), as dose number unknown, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: ANAPHYLACTIC REACTION (medically significant), outcome "unknown", described as "a few anaphylactic reactions"; FOOD ALLERGY (non-serious), outcome "unknown", described as "many new food allergies post covid vaccines".  Clinical course: Reporter stated that the daughter has started with many new food allergies post covid vaccines- a few anaphylactic reactions too. Reporter asked if they have any other reported cased of this occurring.   No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Pt. given FLUMIST (by nose) instead of (IM) flu shot.
Received a varicella vaccine given left tricep at 10:28AM. Pt returned to clinic 4/26/12 at 13:15 complaint of pain. Rash to injection site. Mild rash with some redness noted. Seen by personnel and advised to keep an eye on area and to return if rash increases in size. Left arm normal function.