chrisvoncsefalvay/vaers-outcomes huggingface dataset:
bruising with blood under the skin; scratched right leg and it bled profusely; scratched right leg and it bled profusely; Low grade fever; Face, Neck and Ears turned bright red; headaches; fatigue; This is a spontaneous report from a contactable healthcare professional.   A non-pregnant 49-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection), dose 2 intramuscular, administered on right arm on 22Apr2021 10:30 (Batch/Lot Number: EW0169) as 2nd dose, single (at the the age of 49 years old) for covid-19 immunisation.  The patient medical history was not reported. allergies: Tetanus, metronidazole. Concomitant medications included levonorgestrel (I PILL) taken for an unspecified indication, start and stop date were not reported.  The patient previously took tetanus (TETANUS TOXOID) and metronidazole and experienced known allergies; BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection), dose 1 intramuscular, administered on right arm on 01Apr2021 12:00 PM (Batch/Lot Number: R8733) (at the the age of 49 years old) for covid-19 immunisation and no reaction on previous exposure to drug. The patient experienced low grade fever on 27Apr2021. Face, Neck and Ears turned bright red, headaches and fatigue on 23Apr2021.  Day 4 after injection (26Apr2021), scratched right leg and it bled profusely, with difficulty stopping the bleeding. Day 5 after injection (27Apr2021), had blood drawn from left hand with butterfly needle. When it was removed immediate bruising with blood under the skin, larger then a half dollar coin. Hospital added to check platelet count specimen order.  The patient stated that this is very abnormal for her. Prior to vaccination, was not diagnosed with COVID-19 and since the vaccination, has not been tested for COVID-19. It was unknown if the patient received treatment for the events. The outcome of the events was unknown.   No follow up attempts are possible. No further information is expected.; Sender's Comments: A causal association between BNT162B2 and the reported events cannot be excluded based on a compatible temporal relation. 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 RAs, Ethics Committees, and Investigators, as appropriate.
arm was really sore; depression is really bad today; stomach was slightly messed up; This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (arm was really sore), ABDOMINAL DISCOMFORT (stomach was slightly messed up) and DEPRESSION (depression is really bad today) in a 66-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     Concurrent medical conditions included Thyroid disorder.   On 04-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 06-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 06-Apr-2021,  after starting mRNA-1273 (Moderna COVID-19 Vaccine), the patient experienced ABDOMINAL DISCOMFORT (stomach was slightly messed up). On 07-Apr-2021, the patient experienced DEPRESSION (depression is really bad today). On an unknown date, the patient experienced PAIN IN EXTREMITY (arm was really sore). The patient was treated with IBUPROFEN (ADVIL [IBUPROFEN]) at a dose of 1 dosage form. At the time of the report, PAIN IN EXTREMITY (arm was really sore), ABDOMINAL DISCOMFORT (stomach was slightly messed up) and DEPRESSION (depression is really bad today) outcome was unknown.            Concomitant medication included rixalti, deplan, celexa and a thyroid medication. Treatment medication included Advil.
Within 1/2 hour of injections pt had red swollen warm bump and was complaining of pain. Began to sporadically complain of itching to site as day progressed. Pain increased and at bedtime was given 320mg tylenol. At 1000 the next day tylenol dose was repeated, while he complained of increased itching and itching had now spread to neck, upper chest and armpits. By 1300 pt was complaining of itching eyes and had developed a rash to itching areas as well as periorbital edema. Benadryl 25mg given. Pediatrics office called.
Systemic: Allergic: Difficulty Breathing-Severe, Systemic: Allergic: Difficulty Swallowing, Throat Tightness-Severe, Systemic: Chest Tightness / Heaviness / Pain-Severe, Additional Details: patient got vaccine at our store but called another store to report adverse reaction. other store called us to have us report allergic reaction
positive COVID-19 test; positive COVID-19 test; This is a spontaneous report from a contactable Other health care professional (patient). A 35-year-old female patient not pregnant received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration in Left arm on 16Jan2021 at 09:00 AM (at age of 35-year-old) as a single dose for COVID-19 immunisation, lot number: unknown. Medical history was reported as none. Patient had no allergies to medications, food, or other products. Concomitant medications within 2 weeks of vaccination included rhamnus cathartica, rhamnus purshiana, senna spp. (HERBAL) teas, cynara cardunculus, malus spp. vinegar extract, taraxacum officinale (APPLE CIDER), fluoxetine. Patient did not receive other vaccine in four weeks prior to the COVID vaccine. Prior to vaccination the patient was not diagnosed with COVID-19. Patient caught covid on 30Jan2021 and she was unable to get second vaccine. Events resulted in Doctor or other healthcare professional office/clinic visit. No treatment was received. It was also reported that since the vaccination, the patient had been tested for COVID-19. She underwent laboratory tests and procedures which included sars-cov-2 test (Nasal Swab): positive on 03Feb2021. Patient was recovering from the event, at the time of the report. Information on the lot/batch number has been requested.; Sender's Comments: Based on the current available information and the plausible drug-event temporal association, a possible contributory role of the suspect product BNT162B2 to the development of events Drug ineffective and COVID-19 cannot be totally excluded.  The case will be reassessed if additional information becomes available.
approximately 42 hours post Zostavax vaccination I began to have itching, redness, soreness and swelling at the injection site (about 2 inches in diameter) lasting 2 days.  I treated with topical Temovate cream, topical neosporin with pain relief and ice packs.  At this point there is only mild discoloration at the site w/o symptoms
When attempting to donate whole blood on 3/22/2021, I was rejected due to low iron. When I next went in to donate blood on 8/18/2021, my iron level was back to normal and sufficient for donation. I think this low iron was not a coincidence, since the same thing happened after my booster shot, which I received on 10/7/2021. I went in to donate blood on 10/18/2021 and my iron was low again. When I next attempted to donate blood on 11/29/2021, my iron level was back to normal.
Information has been received from a nurse referring to an unspecified number of patients of unknown age and gender. On unspecified dates the patients were vaccinated with improperly stored PEDVAXHIB lot K026533, expiration date: 07-AUG-2017, (dose, dose #, route and application site were not reported). No adverse effects reported. This is one of two reports received from the same source. Additional information has been requested.
Patient received her first dose of Moderna shot intramuscularly in her left arm on 01/11/2022. She reported today 02/28/22 that she experienced delayed adverse reactions one week after getting the shot. The adverse reactions experienced were an itchy rash on the left arm, right arm and torso; hotness, redness and swelling the size of a tennis ball on the left arm. She reported a telehealth visit with her doctor.
Pt reported to Clinic with concerns of possible reaction to PCV13 on 4/08/2019. Pt has redness and swelling in LT arm. Pt started to have flu like symptoms day after receiving vaccination. Pt states 4 April 2019 her arm started to get warm to touch, body aches , redness and swelling. Pt was using cortisone cream for sx with no improvement. Pt states her sx have improved but still has redness and swelling with some pain. Marked area of swelling in left arm informed pt if sx get worse return to Clinic or ED. Contacted Dr. to inform him of discussion and post care. Dr. agreed for pt to return in sx get worse.
Tonic-clonic seizure approximately 1-2 minutes after crying hard after imms were given.
Pt c/o facial flushing, difficulty breathing at home. State felt flushing within the 20 min in our office but left without notify MD or nurse.
Within 10-minutes of vaccination, the patient reported dizziness when standing up. EMS evaluated the patient on-site. The patient was hypertensive (159/88) with a FSBG of 89mg/dl. EKG demonstrated NSR, rate 61 bpm, no ST elevation. EMS transported the patient to Medical Center Emergency Department. In the ED, the patient denied vertigo symptoms. Labs were grossly unremarkable, but UA did have leukocyte esterase and bacteria. Physician considered 1g Rocephin for UTI, but did not administer due to hives reaction to amoxicillin. Prescribed the patient 5-days of Macrobid PO BID. Discharge diagnoses were lightheadedness and UTI.
blood pressure high; headache; fatigue; This is a spontaneous report from a contactable nurse (patient).   A female patient of an unspecified age received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration on 22Feb2021 (Batch/Lot number was not reported) as single dose for covid-19 immunisation. She had never had problems with her pressure in the past. The patient medical history was not reported. The patient's concomitant medications were not reported. The patient experienced headache, fatigue, blood pressure high, all on an unspecified date. The events outcome was unknown. The patient underwent lab tests and procedures which included blood pressure measurement: 165/134.  No follow-up attempts are possible; information about lot/batch number cannot be obtained.; Sender's Comments: The association between the event high blood pressure with BNT162b2 can not be completely excluded.  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.
became unresponsive, stopped breathing, shaking x 4 minutes, foaming at the mouth, eyes rolled back in head.  After seizure, took 3 hours to wake-up and be alert and responsive.
father also received expired Moderna Covid-19 booster doses; This spontaneous case was reported by a consumer and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (father also received expired Moderna Covid-19 booster doses) in a male patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 007D21A) 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 EXPIRED PRODUCT ADMINISTERED (father also received expired Moderna Covid-19 booster doses). At the time of the report, EXPIRED PRODUCT ADMINISTERED (father also received expired Moderna Covid-19 booster doses) outcome was unknown.            No concomitant medications were reported.  No treatment medication reported.   This case was linked to MOD-2022-544178 (Patient Link).
Mom brought child in. Thigh was swollen and red about 4" X 4". Parent advised to put cool compresses on site; take Tylenol and if not better, take to MD. On 3/27/02, called X 2 to pt's home with no response; left message X 2. No response. Last call on 3/29/02; unable to reach parent. Talked to grandmother. No knowledge of problem. Told her to have daughter call health dept.
This spontaneous report was received from a consumer referring to several unspecified patients. Patients' medical history and concurrent conditions were not reported. On an unknown date, the patients were vaccinated with GARDASIL and due to unspecified physician's belief that the patients were in need for the product due to their participation in a homosexual lifestyle. No product quality complaint was involved. This is one of several reports received from the same reporter. Additional information is not expected since no contact details were provided.
Information regarding PREVNAR was received from a consumer regarding a male patient who experienced fever and seizure. The patient received vaccine. The patient experienced fever and seizure after receiving PREVNAR on an unknown date. The child additionally received other immunisations on the same day. The outcome was not specified. No additional information was available at the time of this report.
Symptoms began about 48 hours after the shot.  I had diagnosed Covid in July 2020.  I believe I am a long-hauler Covid patient as the symptoms flared consistently from July 2020 until present.  They were getting fewer, less intense, and shorter in duration until I received the 1st vaccination.  Now the symptoms have returned and seem to have worsened over the 2 weeks since the shot.  They include: L eye twitching Blurry eyes Visual Disturbances (silver floaters) Neck/Jaw Pain Sporadic Chest pains, both sides Behind L knee pain Swelling in feet/ankles/legs, sometimes hands/face Trouble focusing/Confusion/Forgetfulness Heart Racing/Palpitations (125BPM Resting) BP Sitting: 143/94 L foot vein pain Toe pain Vertigo/Dizzy/Lightheaded GI issues: diarrhea sporadically, gas, reflux, gastritis, stomach pain Insomnia
Initial slight pain at injection site and during arm movement (Upper right arm) on day of injection (Tuesday). Follwing days (Wed, Thursday & Friday); increased pain at injection and during arm movement, lump at injection sight swelling in surrounding area, upper arm warm to touch and redness in same area. Saturday; reduced pain during arm movement, lump still present at injection area but decreasing, minimal pain when touched, no longer any apparant redness, swelling or warmth.
Warm flowing up left side of neck into face; Half of forehead was swollen; Half of forehead was swollen and mushy feeling.; Tightness around left eye; This is a spontaneous report from a contactable consumer, the patient. A 63-year-old non-pregnant female patient received first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Lot Number: EN6208) via an unspecified route of administration in the left arm on 12Mar2021 at 14:45 (at the age of 63-years-old) as a single dose for COVID-19 immunisation. Medical history included allergy to chinese food. 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 vaccination. Concomitant medications included hydrochlorothiazide (MANUFACTURER UNKNOWN), levothyroxine (MANUFACTURER UNKNOWN) and vitamin D (MANUFACTURER UNKNOWN); all for unknown indication from unknown date and unknown if ongoing. On 12Mar2021 at 14:45 (also reported as within 10 minutes of shot), the patient felt something warm flowing up left side of neck into face. The patient's half of forehead was swollen and had mushy feeling. The patient had tightness around left eye. The patient stayed that way for about 4 hours. The events did not result in a visit to the doctors or other healthcare professional office/clinic visit, and emergency room/department or urgent care. Since the vaccination, the patient had not been tested for COVID-19. Therapeutic measures were not taken for the events. The clinical outcome of the events something warm flowing up left side of neck into face, half of forehead was swollen, mushy feeling and tightness around left eye were resolved on 12Mar2021 at 18:45.  No follow-up attempts are needed. No further information is expected.
A couple hours after receiving the vaccine I felt awful, I felt like I had the flu. I slept the whole next day, I had a headache, body ache, stuffy nose, congestion, my joints ached. The next day I felt better and was able to go to work as if I had not felt bad.
Woke up the day following the vaccine -Left upper arm was slightly red. Redness increased as time went on & began to swell slightly & was warm to touch. Mom called the office on 3-15-10 & brought child to the clinic. Advised BENADRYL. Red area 2 1/2 x 2 3/4.
Menactra vaccine was mixed with the wrong diluent by the physician office. Saline was supposed to be used. they used water. The doctor's office is unable to answer effects of this. We were told-- "he got a little" from the doctor's office. this is unacceptable.
The patient presented with hyperkinetic jerking movements of her bilateral upper extremities. This occurred a few days after her 2nd Moderna COVID dose. She has CKD although her renal function was at baseline on hospital admission. Gabapentin was discontinued. By the next morning, the jerking movements stopped. It is unknown if this was due to gabapentin vs the vaccine.
At ZOSTAVAX injection site guest experience redness and swelling at injection site (right arm). Given subq. She has been icing the injection site and taking oral BENADRYL since. Signs/symptoms started and has improved tremendously.
Day after flu vaccine had itchiness at injection site (12/11). On 12/12/08 am mom noticed upper arm to be swollen & hot to touch with c/o persistent itchiness as well.  Saw pediatrician & was directed to give oral antihistamines due to probable vaccine reaction.
1 of 3 pts who recvd DTP/MMR; immunized from the same DTP vial pt devel 8cm area of erythema below inject site; seen by MD; treated w/APAP;
Day 1 - flu like illness Day 2 7 pm acute onset numbness R jaw and neck pain - seen in UC and sent to ER for evaluation of acute stroke symptoms - serial neuro exams normal
High fever, terrible fatigue, cloudy headed and unable to focus. All symptoms went away within 24 hours. I took Motrin for the fever and headache.
Patient fainted during observation period after pfizer covid vaccine. The patient was laid flat on her back with feet elevated and the pharmacy called EMS. The pt left with EMS
Patient's mother stated right arm was 1.5 times bigger than left arm. Arm was also warm to touch and had low-grade fever. Mother applied cool compresses to right arm.
She has been giving it subcutaneously, however, today she gave it intramuscularly, wants to know if that was an approved administration route with no reported adverse event; Initial information received on 12-Dec-2022 regarding an unsolicited valid non-serious case received from a pharmacist.  This case involves 80 years old female patient and pharmacist was giving it subcutaneously, however, today she gave it intramuscularly(vaccine yellow fever vaccine [YF-Vax]), wants to know if that was an approved administration route with no reported adverse event.   The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.  On 12-Dec-2022, the patient received a 0.5 ml dose of suspect yellow fever vaccine with standard strength (frequency: once)(lot UJ654AB and expiry date :10-Nov-2023) (form:unknown) via intramuscular route in the left deltoid for Immunization.  On an unknown date the patient developed a non-serious event of event she has been giving it subcutaneously, however, today she gave it intramuscularly, wants to know if that was an approved administration route with no reported adverse event (incorrect route of product administration) (latency: same day) following the administration of yellowfever vaccine.  Action taken was not applicable.  At time of reporting, the outcome was Unknown for the event  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 the guidelines. 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.
he has back problems; This is a spontaneous report from a contactable consumer (patient). A 78-year-old male patient received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, lot number and expiry date not reported), via an unspecified route of administration on an unspecified date at single dose for COVID-19 immunization. Medical history included colon cancer and melanomas taken out of his neck and ear, but he didn't receive chemotherapy. Concomitant medications were not reported. The patient had back problems on an unspecified date. On an unspecified date, the patient underwent lab tests and procedures which included computerised tomogram and x-ray, both with unknown results. Clinical outcome of the event was unknown.  Information about lot/batch number has been requested.
patient tested positive for Covid-19 9/16/2022, unknown due to no notes received. You will have to contact hospital.
Information has been received from a registered nurse (R.N.) concerning her daughter, a 14 year old female who was vaccinated with a second dose of GARDASIL (lot # not reported).  Subsequently the patient experienced severe blurred vision and a headache immediately after the vaccination.  The patient sought unspecified medical attention.  The patient recovered 12 hours after dose was give.  It was reported that the patient did not have any adverse reactions after the first dose of GARDASIL.  Additional information has been requested.
No adverse event; Patient received Bivalent as a first dose; This spontaneous case was reported by a pharmacist and describes the occurrence of WRONG PRODUCT ADMINISTERED (Patient received Bivalent as a first dose) and NO ADVERSE EVENT (No adverse event) in a 44-year-old male patient who received mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (batch no. 021H22A) for COVID-19 vaccination.     No Medical History information was reported.   On 18-Oct-2022, the patient received first dose of mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (Intramuscular) 1 dosage form. On 18-Oct-2022, the patient experienced WRONG PRODUCT ADMINISTERED (Patient received Bivalent as a first dose). On an unknown date, the patient experienced NO ADVERSE EVENT (No adverse event). At the time of the report, WRONG PRODUCT ADMINISTERED (Patient received Bivalent as a first dose) and NO ADVERSE EVENT (No adverse event) outcome was unknown.      For mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (Intramuscular), the reporter considered NO ADVERSE EVENT (No adverse event) to be not related. No further causality assessment was provided for WRONG PRODUCT ADMINISTERED (Patient received Bivalent as a first dose).    No concomitant medication was reported.  No treatment medication was reported. The patient received bivalent vaccine as a first dose. The patient was on the clinic for second dose on 15-Nov-2022.
Felt minimal side effects from the vaccine (just sore arm) afterwards. But, a few days after I began vaginal bleeding when I am not supposed to get my period. The bleeding has increased each day and is very abnormal for my body. I take birth control and am always on a set schedule with NO spotting/breakthrough bleeding. This has been going on for 4 days, and I am not sure how it will continue and how it will affect my normal menstrual cycle.