chrisvoncsefalvay/vaers-outcomes huggingface dataset:
NAUSEA, FEVER 102,HEADACHE,JOINT ACHES,ABDOMINAL PAIN. DEVELOPED VERTIGO 9 days after 2nd dose and still continuing.
Papule at the site of the injection Fever  Upper Respiratory Symptoms treated with tylenol as needed and compresses at site of injection
Fever, severe body aches, severe chills, vomiting, dehydration, weakness. These symptoms lasted for a full day. Then 2-3 days of recovering from being so sick.
had the 1st 2 shots in Apr2021 and May2021; arm soreness; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 56 year-old female patient received bnt162b2 (BNT162B2), administered in arm right, administration date 08Apr2021 (Batch/Lot number: unknown) at the age of 55 years as dose 1, single for covid-19 immunisation. Relevant medical history included: "Diverticulitis", start date: Jan2021 (ongoing), notes: Verbatim: Diverticulitis; "Retinitis pigmentosa" (ongoing), notes: Verbatim: Retinitis pigmentosa. The patient's concomitant medications were not reported.  The following information was reported: INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (non-serious), outcome "unknown", described as "had the 1st 2 shots in Apr2021 and May2021"; PAIN IN EXTREMITY (non-serious), outcome "unknown", described as "arm soreness".  Additional information: She was first told about her diverticulitis in Jan2021 and she had an issue in her sigmoid area, she had a micro perforation and a small abbess that they had to drain. She had an inflammation that was visible on a CT scan that they did on her pelvis. Arm Soreness: She says that the only symptoms that she had seemed to be that she was tired for so many hours after the 1st COVID vaccines and then she had a little arm soreness afterwards but nothing else. She confirms these were side effects were felt after her 1st and 2nd dose of the Pfizer COVID vaccine. She got those doses in her right arm and for some reason the pharmacist suggested that she have the booster dose in her left arm, which is a different arm. 1st dose ( 08Apr2021) Lot Number: She thinks the lot number is either EN6201 or EIV6201, the handwriting is hard to read.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
T104.5R day p/receiving DTP, diarrhea, questionable sz, was hospitalized 5 days; D/C 9JUN91; F/U visit 10JUN91 still having some diarrhea;
Conjunctivitis 48 degrees after vaccine - treated with breastmilk drops & homeopathic drops; cough, rhinorrhea, sneezing 4 d after vaccine - supportive care; erythematous papules rash 10d after rash. Myalgias 2 weeks after vaccine.
patient fainted shortly after receiving his first dose of Moderna.  Patient reports being anxious prior to his vaccination.  Patient was shaking uncontrollable on chair for approximately 2-3 seconds when I approached him, he may have had seizure but it also may have been the way he fainted in his chair.  patient seemingly lost consciousness for approximately 10-15 seconds and possible had a seizure.  EMS was called and they checked his vitals which were WNL and he was released under his own power
This is a spontaneous report received from a contactable consumer or other non-HCP. A female patient received unknown dose number of BNT162B2 (Pfizer-BioNTech COVID-19 vaccine, batch/lot# unknown), single dose, for COVID-19 immunisation. Medical history and concomitant medications not reported. The patient had a headache, with outcome of not recovered. Additional information: The reporter said his wife experienced some side effects after taking the vaccination. She had a headache that had been going on for 3 days now. She took the vaccine 3 days ago. This follow-up submitted to notify the batch/lot number is not available despite the follow-up attempts made. Follow-up attempts completed. No further information expected.
This spontaneous report was received from a pharmacist refers to a 61 years old female patient with drug reactions/allergic to penicillin. The patient was vaccinated subcutaneously with a dose of 0.65 ml ZOSTAVAX (lot # 672868/0239AE) on 19-JUN-2012. On an unknown date the patient developed a case of shingles. The patient was not recovered. The patient sought medical attention by contacting physician. Additional information has been requested.
The patient had just received her vaccination. She stood up and was waiting on her twin sister to receive hers. She fainted and her mother caught her. She was pale and came around in a few seconds.
On administering Pfizer-BioNTech COVID-19 Vaccine  12/15/20 at 9:15 PM to recipient staff member, vaccinator did not dilute vial and administered undiluted vaccine, resulting in an estimated 5 -fold increase over the intended dose and at an increased concentration.  The error was nearly immediately recognized and disclosed to the recipient staff member. They were observed for adverse reactions and before leaving the clinic they were counseled to immediately report and seek medical attention for any serious signs or symptoms.  A follow up phone call was made the following morning 12/16/20 with soreness at the injection site being the only reported reaction.  They returned to work on 12/17/20 with no additional reported signs or symptoms.
body aches; fatigue; ill; Test: Covid Date:Result: Positive; Lost Sense of smell; chills; Fever reaching 100..8F; feeling sick; This is a spontaneous report received from a contactable nurse. A 50-year-old female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, Batch/Lot number: EL8982) intramuscularly to left arm on 04Feb2021 1:30 at a single dose for COVID-19 Immunization. On 01 Jan2019, patient had started concomitant medications Metformin used for the indication Diabetes, Lovastatin used for the indication cholesterol and Montelukast used for the indication sinus allergy. past medical history pollen and bed bug allergies. On Jan 2021, patient had CXR, Hemoglobin resulted 11.2 and vitamin D. On 09 Feb2021, patient had Covid test and resulted positive On the 04Feb2021 22:30 the patient had experienced Fever and chills. The patient assessed the events as non-serious. She started feeling sick that evening. body aches, chills, and a fever reaching 100.8F. She is still experiencing fatigue. At the time of reporting the events chills, Fever reaching 100..8F were recovering and fatigue was not recovered and body aches, feeling sick, Lost Sense of smell and ill were unknown.
Patient was diagnosed and hospitalized with COVID-19. Hospitalized 7/30-8/10/2021
103.7 rectal temperature night of vaccines.  Mom took pt  to ER had blood work and urine done - negative per Mom.
He presented with one week of progressive symptoms of generalized weakness and shortness of breath. COVID-19 testing was positive.  Patient is vaccinated and boosted for COVID-19.
pt got shots on Friday 11MAR94 & the local react started by Saturday arm was red; Sunday lt arm was twice the size of the other one;pt was taken to MD on 14MAR94; was told was infection started on ATB;
Information has been received from a registered nurse concerning a 23 year old female with allergic reaction to bee sting and a history of Bell's palsy who was vaccinated with her first dose of GARDASIL (IM, 0.5ml, lot # 659184/0843X) on 30-OCT-2008, the second dose (IM, 0.5ml, lot # 661952/1129X) on 16-MAR-2009 and the third dose (IM, 0.5ml, lot # 662300/0100Y) on 26-AUG-2009. Concomitant therapy included FEMCON FE. On 26-AUG-2009 the patient experienced tenderness at injection site after administration of the third dose. She was now experiencing shoulder, neck and arm pain. She was unable to move her arm because of the pain. There were no labs and diagnostic tests performed. The patient sought unspecified medical attention. At the time of the report, the patient had not recovered. Additional information has been requested.
8 minutes after receiving the vaccine, pt appeared to be sleeping in her chair but could not be woken up with verbal stimuli. We then tapped and gently shook patient's shoulder and she still did not respond. She was given 1 EpiPen and 50mg of diphenhydramine injection. She did open her eyes but was not able to respond to questions. She could squeeze both hands. Her breathing was normal at 20 to 20 resp/min. , blood pressure was normal and heart rate was normal. The nurse on duty at the assisted living facility we were at called the ambulance and patient was taken to the local hospital. Patient was sent back to the facility several hours later.
Pink fine papular rash on thigh around injection site started 3/26/10. Improved by time seen on 3/31/10 but still present.
she took a second booster and she passed out and hit her head; Sweating; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP), Program ID. The reporter is the patient.  An 80-year-old female patient received BNT162b2 (BNT162B2), as dose number unknown (booster), single (Batch/Lot number: unknown) at the age of 80 years for covid-19 immunisation. The patient had no relevant medical history. The patient's concomitant medications were not reported. Vaccination history included: Covid-19 vaccine (Primary immunization complete, unknown Manufacturer), for covid-19 immunization; Covid-19 vaccine (First Booster, Unknown Manufacturer), for covid-19 immunization; Flu shot (had the Flu shot first. When probed if received the Flu shot prior 4 weeks: Consumer stated, "Yes.), for Immunization. The following information was reported: LOSS OF CONSCIOUSNESS (medically significant), outcome "unknown", described as "she took a second booster and she passed out and hit her head"; HYPERHIDROSIS (non-serious), outcome "unknown", described as "Sweating".  Clinical course: "This is in regards to medication called Premarin (Further clarification unknown. Hence, captured as suspect conservatively). And the patient made an adverse event statement to me. And the patient did mention, I have a broken ankle, walk with crutches, also mentioned, she takes medication for her stomach. She stated, I can't take any generic stuff (event captured conservatively for unspecified medication captured conservatively). At one time she was enrolled for medication called Protonix, Protonix she indicated (Further clarification unknown. Hence, not captured in tab.) And then she mentioned that she took a second booster and she passed out and hit her head and she stated sweating. She made it sweating and I didn't hear all what she stated sweating (event captured as per transferring agent's verbatim). Sweating, what I heard she said sweating."When paraphrased the concern: Consumer stated, "No. I passed out and hit both of my ankles but one foot is just swollen but the swelling has gone down. The other one, I broke my ankle and I hit my head but I didn't have a concussion so I am normally cast walking. This is my third cast. I took the Pfizer, second booster last, two weeks ago on Friday. Saturday I was ok. Because I am highly allergic to everything (Further clarification unknown). So, Saturday I was ok. But my stomach was bothering me so I took my upper stomach medicine (Intent: Treatment), and on Sunday morning (statement incomplete)."When probed for the name of stomach medicine: Consumer stated, "Dexilant. (Suspect captured as per verbatim conservatively) I have got to walk with crutches so I am not going to get the bottle, ok."  The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.
Red, itchy, warm to touch Ice on and off, Benadryl  Slowly getting better, still slightly red, warm and a little itchy  as of the date of submitting this form
Cold feet; Cannot get warm; This spontaneous case was reported by a consumer and describes the occurrence of PERIPHERAL COLDNESS (Cold feet) and FEELING COLD (Cannot get warm) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.   On 10-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 10-Mar-2021, the patient experienced PERIPHERAL COLDNESS (Cold feet) and FEELING COLD (Cannot get warm). At the time of the report, PERIPHERAL COLDNESS (Cold feet) and FEELING COLD (Cannot get warm) outcome was unknown. Not Provided    The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.   This case was linked to MOD-2021-073997 (E2B Linked Report).   Reporter did not allow further contact; Sender's Comments:  MOD-2021-073997:2nd dose
Muscle aches, low grade fever of 99.8 F, vomiting, weakness and fatigue.
Information has been received from a health professional concerning a patient (31 out of 40) who was vaccinated with Pneumovax 23 (lot number 651406/0620F).  It is unknown if the patient was vaccinated with the influenza virus vaccine (unspecified) on the same day.  Subsequently the patient experienced fever, pain at injection site, redness at injection site, swelling at injection site and red streaks on injection arm.  Subsequently, the patient recovered from fever, pain at injection site, redness at injection site, swelling at injection site and red streaks on injection arm.  The records of testing prior to release of the lot in question have been rechecked and found to be satisfactory.  The lot complies with the standards of the agency and was released.  Additional information has been requested.
I got it on Friday and Under my arm, My arm pit is going to swollen.; This is a spontaneous report from a contactable consumer (patient). A patient of unspecified age and gender received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Lot number and expiration date not reported), via an unspecified route of administration on an unknown date in 2021 as dose number unknown, single for covid-19 immunization. The patient's medical history and concomitant medications were not reported. On an unknown date in 2021, the patient experienced arm pit was going to swollen. The outcome of event was unknown.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Moderna COVID-19 Vaccine EUA   At 12 pm I started to feel tired. As time went by I got more tired as I was cleaning things. I could not do anything for a long time. I laid on the floor for a while and watched videos. I felt better once I did that. I got tired from sitting and laid on the floor. It went until 4 pm April 24 2021. I got up and was fine after taking a nap on the floor.  April 24, 2021 I got a small headache that was there and now comes and goes with longer time periods. From the time I got the shot 10:43am, I felt a headache after it was done to 5pm. It is now going away at 6pm.  I feel pain at the place of shot even more at 3pm it started now at 6pm it has increased. It is bearable.
Hot sensation on my cheek and it was a rash; I had it a couple of days, 2-3 days. End of May, I started having a stomach infection. In June, I developed a sore throat; it might be allergies. I just had to take my nasal cleansing and gargling and cough drop. I also had congestion. I am taking I had those three or four days.  Also, they found a blood clot. I didn't have any symptoms for the blood clot itself. I had to have an abdominal sonogram, CT and X-ray because when they first did it (for a stomach infection) the radiologist found a blood clot in my ovary. The doctor said it was uncommon and unusual. I am taking PRADAXA for three months to dissolve the clot. Before that I was taking another medication to dissolve the clot. In August, due to a past surgery my back surgery (lumbar Laminectomy) was 2018, I have pain that comes and goes; I get strong, sharp pain. It isn't daily but it happens all of a sudden. I was feeling all achy all over.
Information has been received from a registered nurse concerning children who were vaccinated PO with the first dose Rotateq (human bovine) after 12 weeks of age. It was unknown if medical attention was sought. No adverse event was reported. Attempts are being made to obtain additional identifying information to distinguish the individual patients mentioned in this report. Additional information will be provided if available. No further information is available.
Tightness at injection site /Feels hard at injection site; redness at injection site; Swelling at injection site; Soreness at injection site; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE INDURATION (Tightness at injection site /Feels hard at injection site), VACCINATION SITE ERYTHEMA (redness at injection site), VACCINATION SITE SWELLING (Swelling at injection site) and VACCINATION SITE PAIN (Soreness at injection site) in a 72-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On 12-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced VACCINATION SITE INDURATION (Tightness at injection site /Feels hard at injection site), VACCINATION SITE ERYTHEMA (redness at injection site), VACCINATION SITE SWELLING (Swelling at injection site) and VACCINATION SITE PAIN (Soreness at injection site). At the time of the report, VACCINATION SITE INDURATION (Tightness at injection site /Feels hard at injection site), VACCINATION SITE ERYTHEMA (redness at injection site), VACCINATION SITE SWELLING (Swelling at injection site) and VACCINATION SITE PAIN (Soreness at injection site) outcome was unknown. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No concomitant medications were reported. No treatment medications were reported.
15 minutes after receiving her first dose of COVID-19 vaccine in her L arm, patient developed numbness in the L side of her face down to her shoulder. Her CN2-12 were grossly intact, her muscle strength was 5/5 in her UE. Patient denied any SOB, difficulty swallowing (able to swallow water), or swelling of neck. Her airway was patent and she had a normal oropharynx. Patient had another 10 minutes of additional observation. Her symptoms slightly improved prior to leaving.
Next morning/day  l arm pain, resolved after a day; heaviness in arms and legs, slow speech, unbalanced in standing, r arm weakness, r arm/hand numb unable to use. R arm/hand still weak and cannot manipulate with right hand for self-care.  ER visit -- advise to  f/u with PCP. Appointment 12/21/20
The mother became pregnant while taking bnt162b2; Preterm labor which led to delivery of pregnancy; This is a spontaneous report from a contactable physician (patient).   This physician reported information for both mother and fetus.  This is a fetus report. A 29-year-old female mother received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration first dose on 06Jan2021 second dose on 27Jan2021 (Batch/Lot number was not reported) as single dose for covid-19 immunisation.  There was no relevant medical history or known allergies for the mother. The mother's concomitant medications included minerals nos, vitamins nos (PRENATAL VITAMINS), aspirin and cetirizine hydrochloride (ZYRTEC). The mother did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The mother did not have covid prior Vaccination and no covid tested post vaccination.The mother became pregnant while taking bnt162b2 on 06Jan2021 and 27Jan2021. The mother last menstrual period date was 27Oct2020, pregnancy due date was 07Jul2021. It was reported that Preterm labor which led to delivery of pregnancy. This occurred 3 weeks after second dose.The event was resulted in Hospitalization from 2021 to 2021 with duration 1 day. No treatment was received.The events outcome was unknown.  Information on Lot/Batch number has been requested.; Sender's Comments: The information provided is very limited and does not allow for a complete medical assessment.  Based on temporal association, a contributory role of bnt162b2  to the reported events cannot be totally excluded.  Case will be reassessed if additional information is  received.  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.,Linked Report(s) : US-PFIZER INC-2021357940 same reporter, different patient and event
Pt did not receive full dose at time of injection. Syringe leaked part of dose.
CONFIRMED CLINICAL VACCINATION FAILURE; CONFIRMED COVID-19 INFECTION; This spontaneous report received from a patient (himself is physician) via other manufacturer (Pfizer) concerned a 66 year old male. Initial information was processed along with the additional information on 04-AUG-2022. The patient's height, and weight were not reported.  The patient's concurrent conditions included: hyperlipidemia, non-alcoholic fatty liver disease (NAFLD), history of hairy cell leukemia, coronary artery disease (CAD), and an unspecified drug allergy. The patient was physician. The patient previously received three doses of Pfizer biontech covid-19 vaccine (tozinameran, dose number in series 1) (form of admin, and route of admin were not reported, batch number: EKS730 expiry: UNKNOWN) dose was not reported, administered on 29-DEC-2020 in left arm for covid-19 prophylaxis, (form of admin, and route of admin were not reported, batch number: EL3246 expiry: UNKNOWN) dose was not reported, administered on 20-JAN-2021 in left arm for covid-19 prophylaxis and (form of admin, and route of admin were not reported, batch number: EW0198 expiry: UNKNOWN) dose was not reported, administered on 01-AUG-2021 in left arm for covid-19 prophylaxis. It was unknown whether patient had any adverse event following vaccination with three doses of Pfizer biontech covid-19 vaccine (tozinameran, dose number in series 1). The patient received covid-19 vaccine ad26.cov2.s (dose number in series 2) (suspension for injection, route of admin not reported, batch number: 1855190 expiry: UNKNOWN) dose was not reported, 1 total, administered on 11-JAN-2022 in left arm for covid-19 prophylaxis. Age at time of vaccination 65 years old. Concomitant medications included rosuvastatin.  On an unspecified date in 2022, the patient had Covid infection (confirmed covid-19 infection) which led to confirmed clinical vaccination failure (dose number in series 2). The patient underwent COVID-19 rapid POC test which was positive. From 14-JUL-2022 to 18-JUL-2022, the patient received Paxlovid (nirmatrelvir and ritonavir) for treatment of covid-19 (completed 5 days of treatment). On 24-JUL-2022, patient again experienced covid-19 symptoms (rebound Covid infection). On 26-JUL-2022, patient tested positive with rapid test again. At the time of this report, the patient's symptoms persist but no evidence of severe disease. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from confirmed covid-19 infection, and the outcome of confirmed clinical vaccination failure was not reported. This report was serious (Other Medically Important Condition). This report was associated with product quality complaint: 90000245084.; Sender's Comments: V0: 20220805963- covid-19 vaccine ad26.cov2.s- confirmed clinical vaccination failure. The event(s) has a compatible/suggestive temporal relationship, is unlabeled, and has unknown scientific plausibility. There are other factors more likely to be associated with the event(s) than the drug. Specifically: SPECIAL SITUATIONS. Therefore, this event(s) is considered not related.
I'm missing menstrual cycles. I've always been regular and since I've gotten the vaccine it hasn't been regular since. It's still on going for me.