chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Information has been received from a registered nurse concerning a 11 month old male patient with a history of viral induced neutropenia who on 03-FEB-2011 was vaccinated with a dose of VARIVAX (Merck) (Lot # 667980/1102Z, expire date and route not reported). Suspect therapy included a dose of MMR II (Lot #, expire date and route not reported), and VAQTA (Lot #, expire date and route not reported), and PNEUMOVAX 23 (manufacturer unknown, lot #, expire date and route not reported), administered on the same day. Registered nurse stated that on 14-FEB-2011, the patient experienced congestion, "pulling at his ears" vomiting and red papular rash on abdomen and back. No treatment was given to the patient. The patient did not seek medical attention. At the time of the report, patient's outcome was unknown. Registered nurse requested the VZIP test packet. Additional information has been requested.
After he received the vaccination that morning at 9: 30, he was fine, we got home, later that afternoon, he was not himself. He was kind of down, it was expected after the vaccine. He had a temp of 99.5 but I noticed something was off like he was gagging like he was nauseous, I have never experienced that with my other kids. That night he was nauseous and threw up throughout the night. The next morning, he wasn't feeding and a temp that was over 100. Took him to the hospital and he was dehydrated. We had to be transferred to a icu. His blood work was off he was acidic. We stayed in ICU for 3 nights. Now he has an insulin pump. So now after his shots, my son is diabetic. He was never sick before, not even a runny nose.
Initial nausea in middle of the night, then woke up with bad headache and photophobia and back pain.
pt was brought to this ED from Hospital with HRF secondary to COVID 19; pt was complaining of fever and SOB; in shock;  pt had a complicated ED course in hospital due to a prolonged code during airway attempts; required multiple vasopressors; comes to Hospital on 12/26/21 and also has a positive COVID test; pt on APRV and maintaining O2 saturations; minimal brainstem activity; poor prognosis; transitioned to comfort measures; extubated and passed away in the hospital
Dose 1: 29Mar2021; dose 2: 08Apr2021; Severe tinnitus; This is a spontaneous report from a non-contactable consumer, the patient. A 43-year-old male patient received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: UNKNOWN) via an unspecified route of administration in the left arm on 29Mar2021 at 17:30 (at the age of 43-year-old) as a single dose for COVID-19 immunisation and received the second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: UNKNOWN) via an unspecified route of administration in the left arm on 08Apr2021 at 17:30 (at the age of 43-year-old) as a single dose for COVID-19 immunisation. Medical history was not reported. 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 medication was not reported. On 30Mar2021 at 04:00, the patient experienced severe tinnitus. The events did not result in doctor or other healthcare professional office/clinic visits, emergency room/department or urgent care. Therapeutic measures were not taken as a result of the events. Since the vaccination, the patient had not been tested for COVID-19. The clinical outcome of the event severe tinnitus was not resolved at the time of this report.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Intradermal administration did not create wheal. Patient revaccinated  with intradermal dose 2
Staff gave both vaccines 1 inch apart in deltoid muscle, patient came in complaining of sore arm and had a big purple bruise in deltoid muscle region
Around 9pm on 1/06/2021 I started noticing that in the vaccine site I had a little lump it almost looked like a mosquito bite. The next morning it had tripled the size it was super hot to the touch & it was very itchy & it was a little sore & later on that day it started swelling & that's when it became painful. I wen t to employer health & they prescribed me antibiotics. It lasted for 4 days.
Nausea; diarrhea/Have the urge to go to the bathroom every hour; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 26 year-old female patient (not pregnant) received bnt162b2 (BNT162B2), administered in arm left, administration date 20Oct2021 14:45 (Lot number: 30145BA) at the age of 26 years as dose 1, single for covid-19 immunisation. Relevant medical history included: "Asthma" (unspecified if ongoing); "Acid Reflux(GERD)" (unspecified if ongoing), notes: Acid Reflux(GERD). Concomitant medication(s) included: TYLENOL; PEPCID AC. Past drug history included: Prednisone, reaction(s): "Known allergies: Prednisone". The following information was reported: NAUSEA (non-serious) with onset 20Oct2021 19:15, outcome "not recovered", described as "Nausea"; DIARRHOEA (non-serious) with onset 20Oct2021 19:15, outcome "not recovered", described as "diarrhea/Have the urge to go to the bathroom every hour". Therapeutic measures were not taken as a result of nausea, diarrhoea.  Additional information: Patient did not receive any vaccination within 4 weeks prior to the COVID vaccine.  Follow-up attempts are completed. No further information is expected.
Sore right arm for 5 days.; Right arm is red; This spontaneous case was reported by a patient and describes the occurrence of VACCINATION SITE ERYTHEMA (Right arm is red) and VACCINATION SITE PAIN (Sore right arm for 5 days.) in an adult female patient who received mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) for COVID-19 prophylaxis.     Previously administered products included for Product used for unknown indication: JANSSEN COVID-19 VACCINE (Primary series). Past adverse reactions to the above products included No adverse event with JANSSEN COVID-19 VACCINE.    On 03-Nov-2022, the patient received dose of mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (unknown route) 1 dosage form. In 2022, the patient experienced VACCINATION SITE ERYTHEMA (Right arm is red). On 03-Nov-2022, the patient experienced VACCINATION SITE PAIN (Sore right arm for 5 days.). On 07-Nov-2022, VACCINATION SITE PAIN (Sore right arm for 5 days.) had resolved. At the time of the report, VACCINATION SITE ERYTHEMA (Right arm is red) outcome was unknown.            Patient received First Moderna booster dose on 20-Oct-2022 with lot no. 002S21A and Second Moderna booster dose on 19-Apr-2022 with lot no. 067H21A on left arm. No concomitant medications were reported. No treatment details were reported.   This case was linked to MOD-2022-669858, MOD-2022-669857 (Patient Link).
pt recvd vax & devel fever; swelling of thigh; episode of stiffening; jerking; & unresponsiveness lasting several seconds, was nl afterwards on exam next am; 3 x 6 cm area of erythema & induration around site on LL;
This is a spontaneous report received from a contactable reporter(s) (Other HCP) from medical information team for a Pfizer sponsored program. The reporter is the patient. A 43 year-old female patient received bnt162b2 (BNT162B2), administration date 11Aug2021 (Batch/Lot number: unknown) as dose 2, single for Covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: Bnt162b2 (Dose: 01), for COVID-19 immunization. The following information was reported: ARTHRITIS REACTIVE (non-serious), outcome "recovering", described as "Reactive Arthritis". Therapeutic measures were taken as a result of arthritis reactive. Additional Information: Caller reported that, after getting her second dose on 11Aug2021, she developed Reactive Arthritis; currently she feels 99% better because of medication, but in her work they are asking her to take the booster shoot. Caller asks if there is an exemption to take the booster dose for her case. Caller expressed unconformity since there are not enough recommendations regarding exemptions of getting the vaccine for people having specific reactions. Caller also mentioned her opinion that doctors didn't care about administering the vaccine to people with previous reactions. The lot number for bnt162b2 was not provided and will be requested during follow up.
This spontaneous report as received from a medical assistant refers to a 12 year old male patient with no illness at time of vaccination and no known drug allergies. The patient was vaccinated with lot # (670048/0963AA) dose 1 GARDASIL, IM, right deltoid on 28-DEC-2011 at 10:11 AM. No other co-suspects were reported. No concomitant medication were reported. It was reported that the patient received above vaccine during time of refrigerator failure. Temps found to be <32 degrees. The patient was re-vaccinated due to vaccine compromise. No adverse reaction reported. There was no lab studies performed. This is one of several reports from the same source. Additional information is not expected,.
Lost of taste; Metal taste; This case was received via an unknown source (no reference has been entered for a health authority or license partner) on 09-Aug-2021 and was forwarded to Moderna on 09-Aug-2021.    This spontaneous case was reported by a consumer and describes the occurrence of AGEUSIA (Lost of taste) and DYSGEUSIA (Metal taste) 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 first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced AGEUSIA (Lost of taste) and DYSGEUSIA (Metal taste). At the time of the report, AGEUSIA (Lost of taste) and DYSGEUSIA (Metal taste) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No concomitant medication was provided No treatment information was provided
1. super skin reaction to smallpox vaccination 2. cellulitis to upper arm  Referral to Dermatology Clinic
Patient is a 29-year-old lady with no significant past medical history who presented today to my clinic for the first time with complaints of lower extremity weakness; She. got her first dose of  Moderna on August 13 and had a sore arm for couple of days but otherwise felt okay. 4 days after the vaccine she developed severe headache that lasted all day and night, radiating down her back. She took over-the-counter medications with typically help her usual headaches, but they didnt offer any relief; She then developed intense muscle aches and pains. She went to her nurse practitioner who did some blood work, which was reportedly all normal and was started muscle relaxer. This did not help much.  She continue to have
Client was found by a PHN outside the clinic beside his truck on the ground with emesis beside him. On assessment, found a lump on the back of his head about the size of a quarter with a small scrape on his left elbow. Able to move all extremities with full ROM. Pt is awake, able to tell his name but disoriented, unable to tell where he is and what happened. He's pale, cold and clammy and diaphoretic. Assisted back into the clinic and walked without difficulty. Ice pack applied over the back of his head. Supervisor called paramedics and notified mother. Still complained of a severe headache until paramedics came.
When I got the second dose, I had the pain in the site like normal. I got the shot on July 10, and after having finished my last period on July 6, I started another period on July 15 and that lasted until August 7 and it was the heaviest period I've ever had, going through one tampon an hour. And for the past month, i have had intense migraines that have made it next to impossible to function at work. I used to have mild migraines as a kid, but that was 10 years ago and I haven't had them since. I have been to the er for concerns about my symptoms and no one has been able to tell me what is wrong. My labs come back normal, thankfully my heart looks okay on and ekg. I have an gynecology appointment scheduled for next month to start investigating there.
Patient did not have a adverse reaction. She was given the wrong vaccine. She was given a 4th Hepatitis B vaccine when she was supposed to get a Meningococcal B vaccine.
As soon as I was given the injection I felt lightheaded and on the verge of passing out. I sat down and felt a sickness in my stomach. About 3-5 minutes later both of my arms went numb and my fingers started to tingle.
took, both of the vaccines Pfizer one, two, we also took both of the boosters/contracted Covid; took, both of the vaccines Pfizer one, two, we also took both of the boosters/contracted Covid; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 71-year-old female patient received BNT162b2 (BNT162B2), as dose 4 (booster), single (Batch/Lot number: unknown), as dose 3 (booster), single (Batch/Lot number: unknown), as dose 2, single (Batch/Lot number: unknown) and as dose 1, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history included: "diabetic" (unspecified if ongoing). The patient's concomitant medications were not reported. The following information was reported: COVID-19 (medically significant), DRUG INEFFECTIVE (medically significant), outcome "unknown" and all described as "took, both of the vaccines Pfizer one, two, we also took both of the boosters/contracted Covid". Therapeutic measures were taken as a result of covid-19, drug ineffective.  Clinical information: Consumer stated, she was 71 years old, diabetic (Intent: Medical Condition). She and her husband both took, both of the vaccines (Further not clarified hence suspect captured as Unspecified Vaccine) Pfizer one, two, they also took both of the boosters. Her husband contracted Covid which before last but he was able to get his infusion with antibodies but she did not qualify for that (Further clarifications unknown), so her doctor put her on Paxlovid (Further clarifications unknown hence event captured as per verbatim; she and her husband both took, both of the vaccines; so her doctor put her on Paxlovid), the 5 day treatment. she had been feeling better however she had noticed she was retaining some fluid in her left leg, puffiness in ankle and puffiness on 'right' (Further not clarified) but one of her concern was that her left calf that's between her knee and ankle, that's calf right? she had noticed difference in her leg to left one was wider. Then the right one and when we push down it does kind of have a in tension, it finally popped back out (Event captured as per verbatim), so if retaining fluid a side effect of Paxlovid?  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
This spontaneous case was reported by an other health care professional and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Administered the vaccine to 346 patients after the 30 day by used), PRODUCT STORAGE ERROR (Vaccine was stored in refrigerator on 04-Jun-2022 and administered vaccine on 22-Jul-2022) and NO ADVERSE EVENT (No adverse event) in a 71-year-old patient of an unknown gender who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 058A22-2A) for COVID-19 prophylaxis. No Medical History information was reported. On 22-Jul-2022, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) .25 milliliter. On 22-Jul-2022, the patient experienced EXPIRED PRODUCT ADMINISTERED (Administered the vaccine to 346 patients after the 30 day by used). On an unknown date, the patient experienced PRODUCT STORAGE ERROR (Vaccine was stored in refrigerator on 04-Jun-2022 and administered vaccine on 22-Jul-2022) and NO ADVERSE EVENT (No adverse event). At the time of the report, EXPIRED PRODUCT ADMINISTERED (Administered the vaccine to 346 patients after the 30 day by used), PRODUCT STORAGE ERROR (Vaccine was stored in refrigerator on 04-Jun-2022 and administered vaccine on 22-Jul-2022) 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 assessments were provided for EXPIRED PRODUCT ADMINISTERED (Administered the vaccine to 346 patients after the 30 day by used) and PRODUCT STORAGE ERROR (Vaccine was stored in refrigerator on 04-Jun-2022 and administered vaccine on 22-Jul-2022). No concomitant product use was reported. Patient received half dose. Total number of vials used were 35. Date the vial was initially stored in the refrigerator was 04-Jun-2022. Vial did not undergone any temperature excursions. No treatment information was provided.
No reactions besides was sick for the first 3 days after the vaccine however I am reporting that she was 3 when she got the vaccine. Mom has been informed and child has been removed from receiving the 2nd vaccine.
Patient given wrong vaccination. She needed the second dose of the primary series and was given Bivalent booster instead. The patient had no complications or issues with the vaccine.
Skin elevated rash along both elbows, arm pits, front of belly area, buttocks. The rash appeared about 7-8 hours after injection, became pronounced. I took Benadryl 50mg  every 4-6 hours and applied Hydrocortisone cream over skin affected. By 10/22 the rash was less pronounced, however new areas appeared mid day, much less severe than 10/21. Still responding to Benadryl.
1st symptom: Within 30 seconds, ache in arm from elbow to wrist.  Got worse over next few minutes, fairly uncomfortable for about 45 minutes before subsiding slightly (tried to keep moving arm as recommended).  Pain returned when I drove to work and while at my desk.  Lasted for approx 4 more hours.  Injection at 11:15am, pain mostly ended around 9:30pm (except when reaching or extending arm, pain in shoulder now mostly). 2nd symptom: Mild nausea starting about 5 min after injection, while in waiting room.  Passed when laying down at home before work, approx 45 min later..  Started again while driving to work and lasted from about 4pm to 8pm.  Subsided about 10pm.   3rd symptom - feel very fatigued.at typing of this report at 10pm - started about 5pm. So far nothing else - no headache or chills for example.  No pain at all at the actual injection site - now the pain is mostly above it - from the shoulder joint to near the injection site (maybe a couple inches above.) as well as the forearm, all around.   To make coping easier in case the symptoms (arm ache, fatigue, etc) are worse as commonly described from the 2nd dose I put in and was approved for PTO from work for scheduled 2nd date on  March 30th.   Will allow me to rest (avoid being effected at work with the fatigue and an even more achy arm as expected side effects of 2nd dose)
Injection site soreness that was worse over night Headache this morning that would not go away. Has been taking Ibuprofen and Tylenol and just now Tramadol in repeated doses for relief. Fatigue
This spontaneous report was received from a physician, via company representative, and refers to a patient of unknown age and gender. The patient's pertinent medical history, concurrent conditions, drug reactions or allergies and concomitant therapies were not reported. On 09-JUN-2016, the patient was vaccinated with a dose PNEUMOVAX 23 10 PK-0.5 ml SD-PFS LLokwTip, lot # L002310, expiration date 08-JUL-2016 (route and anatomical location of administration were unspecified) which was improperly stored in refrigerator to temperatures excursion of 0 Celsius degrees for 168 hours and 1.1 Celsius degrees for 920 hours with lowest temperatures recorded of 32 and 34 Fahrenheit degrees respectively. No adverse effects were reported and no product quality complaint (PQC) was involved. This is one of several reports received from the same reporter. Additional information has been requested.
COVID Vaccine Breakthrough Dose  Pfizer Dose 1 2/8/21 (el3302) Pfizer Dose 2 3/2/21 (EN6200) Pfizer Dose 3 8/24/21 (EW0177) COVID Positive 12/17/21 COVID Positive 12/26/21  12/24/21: 85-year-old female with pulmonary MAC and bronchiectasis on chronic antibiotics, rheumatoid arthritis and Sjogren syndrome on DMARD, achalasia status post EGD with Botox injection, IBS, severe pulmonary hypertension presented with worsening shortness of breath and cough. Symptoms started about 10 days ago and patient tested for COVID-19 on 12/17 and received monoclonal antibody infusion as an outpatient.  Symptoms  progressively worsened with increasing shortness of breath, dyspnea with exertion and cough productive of blood-tinged sputum.  Patient reports she is usually very active however felt weak and tired. Had fever and chills.  She received both COVID vaccines as well as booster dose.  In the ED patient was afebrile, hemodynamically stable requiring 2 L of oxygen.  Chest CT showed no pulmonary embolism noted bilateral ground-glass airspace disease suggestive of viral pneumonia, patient also have cardiomegaly with findings suggestive of Congestive Heart Failure.  12/28/21: Patient was admitted and started on supplemental oxygen as well as remdesivir, dexamethasone, and Zosyn with doxycycline.  She was also placed on Lasix 20 mg daily. She had slow improvement in her oxygen requirements and was able to be weaned to room air at the time of discharge. She was kept on Zosyn while inpatient and will discharge on Augmentin for 3 additional days.  She also discharge with 3 additional days of Decadron 6 mg daily.  She felt well and will discharge with home health.  She should follow-up with her PCP as well as her regular pulmonologist.
Arm swelled, hot and red with rash. Lasted about a week, subsiding slowly. Treated with ice pack.
Non-febrile seizure approximately 15 minutes returned to baseline by the and evaluation by ER doctor. 03/20/07-records received from facility for DOS 2/16/07-DX:febrile post injection Seizure. HX:became unresponsive to voice, eyes pulled to right side, lasted 1 minuted. Temp 99.6.
Red welt on back of arm about the size of a nickel for 3 days, fussy, difficulty sleeping.
Anaphylactic reaction,  Severe edema and raised red rash entire body, Severe itching ,Soft tissue edema of throat. Swelling of, eyes, lips, face. Multiple trips to ER, treated with steroids, Benadryl, prevacid. , CURRENTLY IN ICU ON EPINEPHRINE DRIP, STEROIDS, MULTIPLE MEDS
Low grade temp 100.5, facial rash, swollen lymph nodes, fatigue, headache that lasted 6 days
2nd Hep B vaccination on 12/17/04, left deltoid arm, shoulder pain
My symptoms include sight nasal congestion and mild cough. I tested positive for COVID-19. I received Paxlovid and started it the same morning. My symptoms lasted less than 24 hours. Two days later, I'm still testing positive without symptoms.