chrisvoncsefalvay/vaers-outcomes huggingface dataset:
she had is a rash from the bottom of her chin through the torso, under her breasts; she had a sore arm for a day after the first injection; a slight headache; This is a spontaneous report from a contactable consumer (patient) reporting about herself.   A 63-year-old female patient (63 rears age at vaccination) received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, Batch/Lot Number: EH9899, Expiration date not reported), intramuscularly, in left arm on 30Dec2020 as single dose for COVID-19 immunisation. The patient medical history and concomitant medications were not reported. A week later after vaccination, on 07Jan2021, the patient experienced allergic rash. When it first came it was just the chin to the breast, it lasted about 4 days then completely stopped and a slight headache. The patient went into the urgent care at the time of report to get an antihistamine for relief because she tried over the counter products and they are not working. Treatment medications for rash included over-the-counter product Cetaphil cleanser (Lot: 316776), Dove peak moisture bath wash (Lot: 08280JU41), Witch hazel astringent (Lot: 53849), Benadryl cream (lot: 2910LV/1, Expiration: Sep2022) and tablets (Lot: SMF075, Expiration: Jul2022), Triderma eczema fast healing face and body cream (Lot: 05440289, Expiration: Oct2023) and calamine lotion (Lot: 541128, Expiration: Nov2017).The outcome of all the events was reported as recovered.  Follow-up attempts are completed. No further information is expected.
Elevated troponin level to 3.5. Chest pain for 2 hours. No signs of CHF. Patient will be evaluated for myocarditis vs ACS during medical admission
Pt recvd vax & devel burning sensation upon inject as well as soreness & or an aching sensation in the arm; pt felt heaviness in the arm;
severe trembling for 48 hours from being cold, 12 hours of vomiting, muscle aches, severe joint pain which I still have 6 months later, numbness in right arm from shoulder to wrist with shooting pain at times.  extremely lethargic.   Chest pains on a daily basis with some dizziness on and off. Menstrual cycle has completely been out of whack with severe cramping at times. All the above have been on going since my second dosage.
Couldn't speak, slurring words, stuttering, couldn't formulate a sentence; stroke; This is a spontaneous report from a contactable consumer. A 97-year-old female patient received first dose of BNT162B2(PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration on 16Jan2021 14:15 at single dose for covid-19 immunization. Medical history included ongoing atrial fibrillation(A-flib), took medication for that. Concomitant medication included acetylsalicylic acid (BABY ASPIRIN), rosuvastatin calcium (CRESTOR). Additional vaccines administered on same date of pfizer suspect reported as no. Prior vaccinations within 4 weeks, AES follow prior vaccinations and family medical history all reported as no. The patient got her first dose on 16Jan2021 and that evening she began to have a stroke. The patient was on blood thinners (apixaban(ELIQUIS) and questor). Event reported as "Couldn't speak, slurring words, stuttering, couldn't formulate a sentence" with onset date 16Jan2021. Event was serious as hospitalization from 17Jan2021 to 18Jan2021. The outcome of the events was not recovered/not resolved. Patient was caller's mother. Four hours later, patient couldn't speak and was slurring words. Ambulance was called, vitals were checked, and patient was told she was ok. Next morning patient was the same. Ambulance was called again and patient had a stroke. Caller stated the stroke was very coincidental. Patient had the COVID-19 Vaccine at about 2PM. Patient had A-fib. Stroke affected patient's speech, but not terribly. Patient was on a blood thinner at the time of the report because of MRI and CT scan results. The patient was taking acetylsalicylic acid (BABY ASPIRIN), but that was taken away at time of the report. The patient was on rosuvastatin calcium (CRESTOR) 0.5 at time of the report. Next appointment for second COVID-19 Vaccine was 06Feb2021. Caller was concerned. Patient never had a stroke before. The reporter wanted to know if this had been previously reported. Saturday night was when patient's speech began slurring. The patient had the Pfizer COVID-19 Vaccine that afternoon. EMS didn't take patient to the hospital on Saturday night, just took vitals and left. Patient's speech was going in and out. Caller reached out to patient Sunday morning and patient was having the same speech issues. Patient was stuttering and couldn't formulate a sentence. Ambulance was called and patient was transported to (health center). CT scan and MRI showed patient had a stroke in the area of the brain that affect speech. Patient had an echocardiogram. Clarified patient's speech symptoms began on Saturday, 16Jan2021.    Information of lot/batch number has been requested.
Developed hives on legs, trunk, buttocks. Unsure of when they began to develop - noticed around 2 AM. Administered Benadryl - hives resolved by 8 AM.
Subacute osteomyelitis of left foot - admitted s/p left second toe amputation for IV antibiotic therapy for treatment of cellulitis.  There was significant gangrenous changes about the toe.  Postoperative course was uneventful. Hospital admission within 6 weeks of receiving the COVID vaccine.
Pins and needles in both arms, very uncomfortable, hard to complete daily tasks, loss of strength in left side, eye droopy, vision blurry, left side of the face went droopy.  All started 9/4.  Started meds around 9/13, diagnosed with Bells Palsey. Followed up 10/1...improving slightly...still some discomfort.  Everything back in full force 11/10.  Followed up again 11/19, was sent to ER for MRI.  Vision is getting worse than it ever has been, arms are very discomfortable,
Heart palpitations around 9:30 pm and again around 11:30 pm, fatigue lasting 2days, slight upset stomach, and dull headache for 2days
Pt recd 2nd Hep B vax 14JUN89 & 16JUN89 exp h/a, achy joints & erythematous rash.On 18JUN89 pt devel urticaria & fever,itching & malaise. On 21JUN89 MD dx "serum sickness" reaction.
Joint aches, persistent headache, onset Saturday. Sunday morning symptoms improved. Midday Sunday had aches, fever to 100F, chills, joint and lower extremity. Local reaction Sunday night with swollen, red upper arm. Advil relieved aches. Monday morning had increased redness, swelling and pain locally. Joints improved.
Since my second shot, a small patch of itchiness on my right anterior hip as well as back of my neck. It continued to spread, and get worse, until the major portion of my trunk, mainly up my right side and back, as well as my shoulder.  It has decreased, but persists in patches. This is now 3 months later
Approx. 30min after administration of the inactivated Influenza vaccine, resident had a swollen tounge, facial drooping, and vomiting. Garbled speech and twitching noted, son stated that speech and twitching was normal for her. VS remained WNL.  Resident was able to follow simple directions.  Son did not want resident to be sent out to the hospital for evaluation.  Advance Directives state DNR and comfort measures only.  Resident has a history of TIA's and seizures.  Resident was monitored and kept comfortable.
pt recv vax; 23jun95 feverish feeling(hot & cold); rt shoulder,arm,shoulder blade tenderness & aching pain; unable to lift rt arm w/o difficulty; swollen area rt side of neck;
Vaccines administered child left clinic without distress. Grandmother returned to clinic with child stating child had fainted and vomited at restaurant. Child appeared flushed, warm and dry. Blood pressure 108/58, pulse 114, temp 98.2. No respiratory distress. One and half teaspoon of Benadryl given. Child observed by FNP in clinic for 30 minutes. Telephone consult with Dr., who recommended follow with pcp. Facility notified and patient transported to clinic by grandmother.
Half dose given by float Pharmacist on 9/29/2022   moderna bi valent 0.25ml given IM Left deltoid
Patient received FLUVIRIN on 9/19/13 at 8PM. Approximately one hour later, patient complained of a bad taste in mouth (metallic) and nausea. At approx. 9:30PM she complained of heaviness/burning/pressure in chest. She had on/off pain starting in the right shoulder and moving to the left shoulder. She left for the hospital at 10:15PM. She took a nitroglycerin tablet while in route but it helped only slightly. She was admitted at 10:45PM. I spoke with patient who was at home, she is doing fine (no symptoms).
About 6 hours after vaccine patient presented with extremely sore arm and felt fatigued and like he had been "hit by a train" for a full 24 hours from the symptom onset. Patient also reported headache and body aches chills and low fever in 99-100 range.
This case was reported by a healthcare professional (nurse practitioner) via sales representative and described the occurrence of injection site abscess in an infant subject of unspecified gender who was vaccinated with PEDIARIX (GlaxoSmithKline). Concurrent vaccination included PREVNAR (non-gsk); non-GSK manufacturer; unknown; right thigh given on an unspecified date; unspecified vaccine; manufacturer unspecified; unknown; right thigh given on an unspecified date. On an unspecified date the subject received 3rd dose of PEDIARIX (unknown, left thigh) as the 6-months series vaccination for PEDIARIX. At an unspecified time within months of 3rd vaccination with PEDIARIX, the subject experienced injection site abscess and nodule injection site. The infant subject received the full 2, 4 and 6 months series of PEDIARIX; the specific age of the baby was not provided. After each injection of PEDIARIX on unknown dates, the baby had nodules from on the leg. All three doses of PEDIARIX had been injected in the left thigh. All of the nodules formed on the same thigh and were localized to the exact same area where the PEDIARIX was injected. Other vaccines, included PREVNAR, had been administered on the right thigh with no nodules. The infant subject was scheduled to have surgery to have pus taken out/ drained of the little abscesses that have formed. The reporting nurse practitioner was not certain that this was even related to PEDIARIX. This case was assessed as medically serious by GSK. The immunization series with PEDIARIX was not discontinued. At the time of reporting the injection site abscess and nodule at injection site were unresolved. Please see cases A1059527B and A1059527C for the subject's experience with previous doses of PEDIARIX.
Pain on the arm; Body ache; Itching by the hands and face (lips); Itching face(lips); This is a spontaneous report from a contactable consumer, the patient. A 44-year-old non-pregnant female patient received first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; lot number: Ep7534) via an unspecified route of administration in the left arm on 22Mar2021 at 13:15 pm (at the age of 44-years-old) as a single dose for COVID -19 immunisation. Medical history was not reported. The concomitant medication included sulfamethoxazole, trimethoprim (BACTRIM). The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Prior to the vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. On 22Mar2021, the patient experienced Pain on the arm, Body ache, Itching by the hands and face (lips). The patient did not receive treatment for the reported event. The adverse event did not result in a visit to the doctors or other healthcare professional office/clinic visit, and emergency room/department or urgent care. The clinical outcome of the Pain on the arm, body ache and itching by the hands and face (lips) was unknown at the time of this report.   No follow-up attempts are needed. No further information is expected.
s/s : stood and  experience dizziness and  diaphoresis. shaky hands and  vomitting .  denied cough , no shob, no chest pain.  sat in resting position , vs taken: 124/90 hr 120 sat  93%ra, stated had previously taken bp  about 5 minutes sooner and was 150/110. hrr regular tachy. able to voice needs or feelings. stated did not take her daily  medication today. cool cloths applied to  forehead , back of neck and wrists. applied  oxygen for comfort /anxiety. states has panic attacks . Notified family, called EMS for evaluation.
Vaccine was administered to patient.  Patient was walked to chair in waiting area and fainted.  Once patient fainted, he immediately recovered.  No treatment was necessary and left after 15 minutes
This is a spontaneous report received from a contactable consumer or other non-HCP (patient) for a Pfizer sponsored program (159558). A male patient received the 1st dose of BNT162B2 (Comirnaty, batch/lot# unknown), on Mar 19, 2021, single dose, for COVID-19 immunisation. The patient's medical history and concomitant medications not reported. The patient experienced  myalgia/little muscle soreness, with outcome of unknown. No follow-up attempts possible. Information about batch/lot number cannot be obtained. No further information expected.
No adverse event; expired monovalent vaccine was administered; This spontaneous case was reported by a pharmacist and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (expired monovalent vaccine was administered) and NO ADVERSE EVENT (No adverse event) in an 11-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. AR6965B) for COVID-19 prophylaxis.     No Medical History information was reported.    On 05-Dec-2022, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) .5 milliliter. On 05-Dec-2022, the patient experienced EXPIRED PRODUCT ADMINISTERED (expired monovalent vaccine was administered). On an unknown date, the patient experienced NO ADVERSE EVENT (No adverse event). At the time of the report, EXPIRED PRODUCT ADMINISTERED (expired monovalent vaccine was administered) and NO ADVERSE EVENT (No adverse event) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter considered NO ADVERSE EVENT (No adverse event) to be not related. No further causality assessment was provided for EXPIRED PRODUCT ADMINISTERED (expired monovalent vaccine was administered).    Concomitant medication was not reported. Patient Did not receive any other vaccines in the 4 weeks prior to COVID-19 vaccine. Treatment drug was not reported.
Pt reports tenderness at injection site left deltoid. Then developed sore throat, swollen  left side neck glands.
DOS 10/14/22- Patient received a Pfizer Monovalent booster instead of a bivalent booster. Patient's parent has been informed of the vaccine administration error.
COVID-19/Vaccination failure; COVID-19; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 57-year-old male patient received BNT162b2 (BNT162B2), on 10Mar2021 at 08:00 as dose 1, single (Lot number: EN6206), in left arm, on 07Apr2021 at 08:00 as dose 2, single (Lot number: ER8737), in left arm, on 08Oct2021 at 15:00 as dose 3 (booster), single (Lot number: FF2590), in right arm and on 15Apr2022 at 15:00 as dose 4 (booster), single (Lot number: FK9893) at the age of 57 years, in right arm for covid-19 immunisation. The patient's relevant medical history included: "known allergies: penicillin" (unspecified if ongoing). Concomitant medication(s) included: LIPITOR, start date: 01Jan2018. The following information was reported: VACCINATION FAILURE (medically significant), outcome "not recovered", described as "COVID-19/Vaccination failure"; COVID-19 (medically significant), outcome "not recovered". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: Positive, notes: Day 11 my cough has come back with some shortness of breath not previously experienced and still testing positive with much darker line on the Antigen test; Unknown results. Therapeutic measures were taken as a result of vaccination failure, covid-19.  Clinical course: The report about covid treatment. Other medication in 2weeks reported as yes. Anti viral details reported as product was COVID 19 Treatment. Brand name was Pfizer. Treatment start date was 04Jun2022, treatment stop date was 09Jun2022. Indication reported as treatment of COVID-19. other medication in 2weeks product was Lipitor. other medication in 2weeks start date was 01Jan2018. Adverse event was day 11 patient cough has come back with some shortness of breath not previously experienced and still testing positive with much darker line on the Antigen test. Patient recovered was recovering and treatment AE was no.    No follow-up attempts are possible. No further information is expected.
interface dermatitis; This is a spontaneous report from a contactable Physian. A 82 years male patient received first dose of   BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: Solution for injection, Lot number:unknown), via an unspecified route of administration, administered in Intramuscular left arm on 11 Feb 2021 at the age of 82 years old as single first and second dose for COVID-19 immunisation. Patient medical history included COPD and decreased renal function. concomitant medications were not reported. Patient was allergie to IVP contrast dye. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. On 18 Feb 2021, the patient had experienced Skin eruption distal feet (incl. toes), both palms, both knees. Biopsy reveals interface dermatitis. At the time of reporting, the event was recovering/resolving.  Information about lot/ batch number has been requested.
I have a history of heavy periods which resulted in the need for an ablation in October 2018. Since the ablation my periods have been much more manageable. I got my period 13 days after receiving the shot and it started out much heavier than normal, by the second day I was bleeding extremely heavily, soaking an overnight pad in less than 2 hours with bright red blood and passing clots the size of dimes and pennies. Day 3 has started out the same as day 2. Prior to my period starting my back hurt and I had much worse than normal abdominal cramps. Nothing in my life has changed besides the vaccine, I am certain there is a connection between the two. I am not sure how long this will last, I was instructed to go ahead an report the adverse event.
pt recvd vax & rt sided sz activity involving rt lower extremities but progressing to rt upper extremity & neck; lasted several seconds, occurred several times; no response to therapeutic meds;
Information has been received from a physician concerning a 14 year old female who on 01-DEC-2007 was vaccinated 0.5mL, IM with Gardasil (Lot# not reported).  Following her vaccination the patient experienced flu like symptoms that lasted about 3 days.  Subsequently, the patient recovered from flu like symptoms.  The patient sought unspecified medical attention at her physician's office.  Additional information has been requested.
On 13-AUG-2018, the patient was vaccinated with an improperly stored dose of GARDASIL 9 (lot # R004689; expiration date: 29-NOV-2020) or (lot# R006689; expiration date: 29-NOV-2020) (dose and route of administration were not reported) for prophylaxis, which had a temperature excursion of 47°F to 77°F (56F) for 15 days on unspecified dates. There were no previous temperature excursions and no digital data logger involved in recording the temperature excursion. No adverse effects were reported. This is one of several reports from the same source. Sender's Comments: US-009507513-1808USA012996: US-009507513-1809USA006251: US-009507513-1809USA006253: US-009507513-1809USA006254: US-009507513-1809USA006255: US-009507513-1809USA006256: US-009507513-1809USA006257: US-009507513-1809USA006258: US-009507513-1809USA006259: US-009507513-1809USA006260: US-009507513-1809USA006261: US-009507513-1809USA006262: US-009507513-1809USA006263.
Headache; chills; Feel empty; Diarrhea; Aches and pain; I cannot move my arm barely with where I got the shot at; I got the shot at and I looked my arm was swollen; This is a spontaneous report from a contactable consumer (patient). A 32-year-old female patient received second dose of  BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: unknown), via an unspecified route of administration on 07Jan2021 12:00 in the arm at single dose for COVID-19 immunization. Medical history was reported as none. Concomitant medication included paracetamol (TYLENOL). The patient stated, "I just wanted to report some side effects. I am on my second dose now and I am having (incomplete sentence), first of all, I had diarrhea as of last night in Jan2021. I had chills all way down to my bones as of yesterday like almost immediately after I received the shot. I feel empty, I got chills on 07Jan2021. I had a slight headache this morning on 09Jan2021 and I am also dealing with a lot of aches and pain however just now because I cannot move my arm barely with where I got the shot at and I looked my arm was swollen in Jan2021." The outcome of the events was unknown. The facility where the most recent COVID-19 vaccine was administered was in the hospital.  Information about Lot/Batch number is requested.
This spontaneous case was reported by a health care professional and describes the occurrence of ANXIETY, FEELING ABNORMAL (feels like tickling inside), ENERGY INCREASED and PSYCHOMOTOR HYPERACTIVITY in a 37-year-old male patient who received mRNA-1273 (MODERNA COVID-19 Vaccine) for COVID-19 vaccination. The patient's past medical history included Pacemaker insertion (cardiac). Concurrent medical conditions included Wolff-Parkinson-White syndrome. On 22-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 22-Apr-2021, the patient experienced ANXIETY (feels anxious), FEELING ABNORMAL (feels like tickling inside), ENERGY INCREASED (feels energetic) and PSYCHOMOTOR HYPERACTIVITY. At the time of the report, ANXIETY (feels anxious), FEELING ABNORMAL (feels like tickling inside), ENERGY INCREASED (feels energetic) and PSYCHOMOTOR HYPERACTIVITY (feels hyperactive) outcome was unknown. Not Related      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   Patient  was on the waiting list for a heart transplant. No  concomitant medications provided. No treatment information provided.
Within 10 minutes of receiving the vaccine, my fingers on my left hand began to tingle and progressed to my forearm within 15 minutes. that evening, I began to have heart palpitations with heart rate fluctuating between 80 - 120 bpm.  The next day, a sever migraine began and the pain radiated down to my neck and fever of 99.8 with fatigue.  A of today 11/16/21, 6 days later, my arm is still tingling and I still have the migraine. the heart palpitations have for the most part stopped and I'm back to a regular heart rhythm.
1530 - receive vaccine 1540-c/o itching at site and hot flashes.  Site was red and raised.  Sbp 118/75, hr 68, rr 20, sats 97.  25 mg of bendaryl given po. 1344 - hr 69.  HR ranged from 68-70 1550-walked in hallway. 1550 - hot flashes ended.  Injection site remained red and itchy 1600-pt dcd home