chrisvoncsefalvay/vaers-outcomes huggingface dataset:
12/30 Mom noticed swelling at injection site after 5:00PM , 0 fever; spoke with on call triage nurse; applied cool compress; Rx Benadryl, Motrin 12/31 erythema  +  swelling slightly larger than 12/30 at 2in diameter; afebrile; will cont treatment cool compress, Motrin + Benadryl
This case was reported by a physician via sales rep and described the occurrence of induration in a 15-month-old female patient who received INFANRIX for prophylaxis. Co-suspect products included VARICELLA VACCINE for prophylaxis. On 18th June 2018, the patient received INFANRIX and VARICELLA VACCINE. In June 2018, less than a week after receiving INFANRIX, the patient experienced induration and redness of legs. On an unknown date, the outcome of the induration and redness of legs were unknown. It was unknown if the reporter considered the induration and redness of legs to be related to INFANRIX. Additional details were provided as follows: The patient was administered INFANRIX and Varicella vaccine on right leg. On 20th June 2018, the patient came to the physician as had a 3 by 4 red hardened area on leg.
6/24/21 - right shoulder blade/chest pain and shortness of breath. Diagnosed as Pulmonary embolism in ER - 2 day hospital stay - put on Eliquis for 6 months - still have pain from time to time underneath right breast area  9/25/21 - visit to ER with left shoulder blade/chest pain. Abnormal ECG 12 Lead - SINUS RHYTHM WITH FREQUENT PREMATURE VENTRICULAR COMPLEXES, POSSIBLE LEFT ATRIAL ENLARGEMENT, POSSIBLE ANTERIOR INFARCTION, T WAVE ABNORMALITY, CONSIDER INFERIOR ISCHEMIA.  Portable chest xray showed the lungs are fully expanded demonstrating mild bibasilar atelectasis, no focal consolidation, effusion, or pneumothorax.  Being seen by cardiologist - to have nuclear stress test on 11/17/21 and to wear a holter monitor for 2 weeks after the stress test. Have been having chest pains and pain directly underneath both breasts off and on.
Severe Sore Throat, Trouble Swallowing, Drinking, and Eating; Severe Body Aches, Chills, Sweating, Headaches; Went to the emergency room four days after receiving my booster shot, was diagnosed with pharyngitis. Prescribed five days of steroids, ten days of antibiotics, and three weeks of fluconazole. Six days after receiving my booster shot, my lab results came back and said I tested positive for strep throat.
Information has been received from a patient's father concerning his 12 year old daughter, who on an unspecified date was vaccinated with the first 0.5ml dose of GARDASIL (lot # not provided). Subsequently the patient turned white and nearly fainted after getting the first dose of GARDASIL. At the time of the report the patient's outcome was unknown. No laboratory diagnostics studies were performed. The patient did not seek medical attention. No further information is available.
About 10 days post vaccination he developed pain above deltoid on Lt now moving up shoulder to neck.
Headache, Myalgia, NauseaVomiting, pain in armpit Narrative:  day 1-3 pain/tenderness/muscle pain at vaccination site, nausea, day 4 headache/nausea. day 5 vomiting. day 6 pain in arm pit.
I scanned the bar code to receive questions daily, everyday I reported my symptoms for 1 week left hand finger numbness the next day,chest discomfort, 8/9th lower back pain, kidney area, dark urine Aug 10th vertigo severe while at work, labs and EKG, fast heartbeat 8/19th pcp appt dizziness, right eye pressure 8/21st NP telephone appt for Vertigo and off balance feeling while at work 8/23 NP appt 8/25th covid test negative 8/26th EKG and labs, persistant equillibrium issue since 8/21st and fast heart beat positional, difficulty concentrating
Information has been received from a physician concerning an 81 year old female with penicillin allergy and no other pertinent medical history who on 25-APR-2008 was vaccinated in the right deltoid with zoster vaccine live (Oka/Merck) (lot number 659323/0164X). Concomitant therapy included simvastatin (MSD) and alendroanate sodium (MSD). On 27-APR-2009 the patient developed two itchy spots on her left forearm,. One of the two spots resolved. The other spot was 1.5 cm in diameter and centrally, about 1 cm, and there was a mild induration. The reporting physician indicated the spot looked like a bug bite. There were no vesicles and no crusting. At the time of the report, the second spot was improving. The reporting physician further indicated the patient had been home bound since she did not want to transmit the vaccine virus to others. No laboratory/diagnostic studies were performed. The patient sought medical attention through the reporting physician. Additional information has been requested.
Severe redness and swelling surrounding injection site, pt has not been able to lift her arm; she was in the ER for another reason the the ER staff palpated her reaction noting nodular bumps in the inflamed area
I couldn't use my left arm; My arm was sore at injection site; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE MOVEMENT IMPAIRMENT (I couldn't use my left arm) and VACCINATION SITE PAIN (My arm was sore at injection site) in a male patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.   On 26-Oct-2021, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On an unknown date, the patient experienced VACCINATION SITE MOVEMENT IMPAIRMENT (I couldn't use my left arm) and VACCINATION SITE PAIN (My arm was sore at injection site). At the time of the report, VACCINATION SITE MOVEMENT IMPAIRMENT (I couldn't use my left arm) and VACCINATION SITE PAIN (My arm was sore at injection site) outcome was unknown.            No concomitant medications were reported. No treatment medications were reported.   This case was linked to MOD-2021-406160 (Patient Link).
not injected into the middle of the deltoid, but rather on the side of the arm; sore arm; swollen about 2-3 inch area, circle, red, and warm; Vaccination Site Red; A spontaneous report was received by a consumer regarding herself an 88-year-old female patient who experienced the vaccine not injected into the middle of the deltoid, but rather on the side of the arm/Incorrect route of product, sore arm/vaccination site pain, swollen about 2-3 inch area circle raised, red and warm/vaccination site swelling, and vaccination site red/vaccination site erythema.  The patient's medical history was not provided. No concomitant medications provided.   The patient received the first of two planned doses of mRNA-1273 (Batch number 030L20A) injected into the side of the left arm for prophylaxis of COVID-19 infection.  On 28 Jan 2021, the patient received her vaccine, but noted that it was not given in the middle of the deltoid, but rather on the side of the arm. She also had a sore arm,  swelling reported as about a 2-3 inch circle which was red and warm. Treatment information was not provided.   Patient consented to be contacted.  Action taken with mRNA-1273 in response to the events was not reported.   The outcome of the events, vaccine not injected into the middle of the deltoid, but rather in the side of the arm, sore arm,  and a 2-3 inch circle that is raised, red and warm, was considered resolved.; Reporter's Comments: The events developed on same day after first dose of mRNA-1372. Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded.
Information has been received from a lawyer regarding a case in litigation concerning a male patient of unknown age. No information was received regarding the patient's past medical history, concurrent conditions, or concomitant medication. The patient's healthcare provider recommended and/or prescribed the ZOSTAVAX to the patient for its intended purpose of permanent prevention and protection against shingles and zoster-related conditions. On an unknown date in 2013, a healthcare provider at a pharmacy administered the ZOSTAVAX to the patient (lot number, dosage and route of administration not provided). On or about 13-DEC-2016, the patient was treated by a healthcare provider for shingles. The patient was diagnosed with shingles and/or other zoster-related injuries after and despite being inoculated with the ZOSTAVAX vaccine, and suffered serious physical, emotional, and economic damages as a result of the patient's injuries. As a direct and proximate result of the ZOSTAVAX vaccine, the patient has and will continue to suffer ongoing injuries, including but not limited to: mental and physical pain and suffering; extensive medical care and treatment for these injuries; significant medical and related expenses as a result of these injuries, including but not limited to medical losses and costs including care for hospitalization (dates unknown), physician care, monitoring, treatment, medications, and supplies; diminished capacity for the enjoyment of life; a diminished quality of life; increased risk of premature death, aggravation of preexisting conditions and activation of latent conditions (unspecified); lost wages; loss of earnings capacity; and other losses and damages. The outcome of the events is considered to be not recovered. Additional information has been requested.
Upper lip itch; Drug exposure during breast feeding; 25% reduction in breast milk/60% reduction in breast milk/50% reduction in breast milk; Injection arm became sore; Lips tingling; Upper lip became numb; This spontaneous case was reported by a health care professional and describes the occurrence of PARAESTHESIA ORAL (Lips tingling), HYPOAESTHESIA ORAL (Upper lip became numb), LIP PRURITUS (Upper lip itch), VACCINATION SITE PAIN (Injection arm became sore) and SUPPRESSED LACTATION (25% reduction in breast milk/60% reduction in breast milk/50% reduction in breast milk) in a 30-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 026A21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     Concomitant products included PRENATAL VITAMINS [ASCORBIC ACID;BIOTIN;MINERALS NOS;NICOTINIC ACID;RETINOL;TOCOPHEROL;VITAMIN B NOS;VITAMIN D NOS] for an unknown indication.    On 15-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 15-Mar-2021, the patient experienced PARAESTHESIA ORAL (Lips tingling), HYPOAESTHESIA ORAL (Upper lip became numb) and VACCINATION SITE PAIN (Injection arm became sore). On 16-Mar-2021, the patient experienced SUPPRESSED LACTATION (25% reduction in breast milk/60% reduction in breast milk/50% reduction in breast milk). On an unknown date, the patient experienced LIP PRURITUS (Upper lip itch) and EXPOSURE VIA BREAST MILK (Drug exposure during breast feeding). On 15-Mar-2021, PARAESTHESIA ORAL (Lips tingling), HYPOAESTHESIA ORAL (Upper lip became numb) and LIP PRURITUS (Upper lip itch) had resolved. At the time of the report, VACCINATION SITE PAIN (Injection arm became sore), SUPPRESSED LACTATION (25% reduction in breast milk/60% reduction in breast milk/50% reduction in breast milk) and EXPOSURE VIA BREAST MILK (Drug exposure during breast feeding) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   Patient was breastfeeding. Patient treatment medication included Power pumping, Lactation cookies.
Had a fibro flare from head to toe.  I have never had this before.  My skin/body was in hyper sensitivity and pain from my head to the bottoms of my feet.  I then developed ezcema on my neck, which I have never had before and just went to a doctor for that.  I did not go for the fibro flair as I know there is nothing that can be done for that.
Fainted; Didn't know what had happened.; vomited; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 17-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 04Aug2021 at 14:30 as dose 1, single (Batch/Lot number: unknown) at the age of 16 years, in left arm for covid-19 immunisation. The patient's relevant medical history included: "Allergies" (unspecified if ongoing), notes: other medical history: Allergies; "anxiety about Covid-19" (unspecified if ongoing), notes: other medical history: anxiety about Covid-19; "Known allergies: Tree nuts" (unspecified if ongoing), notes: Known allergies: Tree nuts. Concomitant medication(s) included: ZYRTEC ALLERGY taken for multiple allergies; ASMANEX. Past drug history included: Cephalosporins, reaction(s): "Known allergies: Cephalosporins", notes: Known allergies: Cephalosporins. The following information was reported: FEELING ABNORMAL (non-serious) with onset 04Aug2021 at 14:30, outcome "unknown", described as "Didn't know what had happened."; SYNCOPE (medically significant) with onset 04Aug2021 at 14:30, outcome "unknown", described as "Fainted"; VOMITING (non-serious) with onset 04Aug2021 at 14:30, outcome "unknown", described as "vomited". The events "fainted", "didn't know what had happened." and "vomited" required emergency room visit. The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: Negative. Therapeutic measures were taken as a result of syncope, feeling abnormal, vomiting. Clinical Information: Facility type vaccine was Pharmacy or Drug Store. No other vaccine in four weeks. Other medications in two weeks included Zyrtec for allergies, Asmanex daily inhaler. The patient had no covid prior vaccination.  The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.
patient really shot the next day got sick; Initial information was received on 16-Jan-2021 regarding an unsolicited valid non-serious from a consumer/ non-heath care professional.  This case involves a patient of unknown age who got sick (illness), while being received vaccine INFLUENZA VACCINE.  Medical history, past medical treatment, vaccination, family history and concomitant medication were not reported.  Concomitant medications were not reported.  On an unknown date, the patient received a dose of suspect INFLUENZA VACCINE (batch number and other dosing details were not reported) at an unknown dose via unknown route and unknown administration site for prophylactic vaccination.  On an unknown date, (latency: unknown) after starting the suspect vaccine therapy, patient was sick the next day (illness).  No laboratory data was reported.  It was not reported if the patient received any corrective treatment.  Outcome of the event was reported as unknown.
RN gave vaccines in left thigh. Pt held her breath. RN blew in face to get her to breathe. Pt took large gasp then went limp, with eyes deviating, not breathing for approx 3 seconds. Took breath and had another episode. Kept crying after. Vs WNL. Monitored pt for 1.75hrs.
I got first shot then was very confused; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 69 year-old male patient received bnt162b2 (BNT162B2), administered in arm left, administration date 02Apr2021 13:00 (Lot number: Er8732) at the age of 69 years as dose 1, single for covid-19 immunisation. The patient had no relevant medical history. There were no concomitant medications. The following information was reported: CONFUSIONAL STATE (non-serious) with onset 23Apr2021 09:00, outcome "not recovered", described as "I got first shot then was very confused". The event "i got first shot then was very confused" was evaluated at the physician office visit. Therapeutic measures were taken as a result of confusional state.  No follow-up attempts are possible. No further information is expected.  Additional information: It was reported that Dose 2 details: Suspect Product: Pfizer COVID 19, Batch/lot number: Ewo173, Date of start of drug: 07May2021 at 01:00 PM, Anatomical Location: Arm Right, Dose Number: 2. Reported Event: This started 5 was after I got first shot then was very confused and could not drive to get 2nd dose daughter drove me now seeing a neurologist since 28Jun2021. Outcome of reaction was Not Recovered/Not resolved. The patient had received treatment for adverse event. The patient no history of medical history, concurrent conditions and no past drug history. Facility where the most recent COVID-19 vaccine was administered was Hospital. Patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Patient did not receive any other medication within 2 weeks. Did the adverse event result in any of the following? Doctor or other healthcare professional office/clinic visit. What treatment received for the adverse event? Mental confusion. Patient was not diagnosed with COVID-19 prior vaccination. Patient has not been tested for COVID-19 since vaccination.  Follow-Up#1 (08Sep2021): Follow-up attempts are completed. No further information is expected.
This spontaneous report was received from a pharmacist refers to a 33 year old male patient. The patient's pertinent medical history and concurrent conditions were not provided. On an unknown date, the patient was vaccinated with GARDASIL 9 (route, lot number and expiration date were not provided). Concomitant therapy information was not provided. On an unknown date, there was an inappropriate schedule of drug administration as GARDASIL 9 had been administered beyond the recommended age range. No adverse event was reported. It was unknown if the patient sought medical attention. At the time of the report, the patient's status was unknown. This is one of several reports received from the same reporter. Additional information has been requested.
One week after 1st shot came down with multiple symptoms excluding vomiting and fever. After 2nd shot at 9:30 AM at 12:oo noon came down with like symptoms that lasted in the neighborhood of 2 weeks.  2nd shot had a temperature rise to 100.3 from a normal of 67.00 to 97.0  Temperature was intermintent.
06-04-2021 developed headache and vision changes. Dx with occular migraine.
I was on my 4th week pregnancy. The next day I took my second dose I had spotting and the third day I'm having a miscarriage. ( this is my third pregnancy); I was on my 4th week pregnancy. The next day I took my second dose; I was on my 4th week pregnancy. The next day I took my second dose; This is a spontaneous report from a contactable Other HCP (patient). A 43-year-old female patient (pregnant) received bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Lot Number: EP7534), second dose via an unspecified route of administration, administered in Arm Left on 13Apr2021 14:45 (at 43 years old, pregnant), single dose for covid-19 immunisation. The patient's medical history included that this was her third pregnancy. The patient's  concomitant medications were not reported.  The patient had his first dose of bnt162b2 on 23Mar2021  14:45 for covid-19 immunisation, left arm, lot number EP7534. Patient was on her 4th week pregnancy. The next day, she took her second dose, she had Spotting and the third day (also reported as 14Apr2021 15:00) she was having a miscarriage. Treatment was Received. The outcome of the event Miscarriage of pregnancy was recovering. No covid prior vaccination. Patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient has not been tested for COVID-19. No Allergies to medications, food, or other products.; Sender's Comments: Based on the information currently available and known safety profile of the drug, a possible contributory role of suspect product Bnt162b2 to the reported events can not be ruled out. But product is not indicated in this population group.  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.
Employee states about an hour after receiving the vaccine she became confused , couldn't focus couldn't get her words out , she went to urgent care and they told her is was " serum sickness they gave her a shot of steroids
Information has been received from an 18 year old female consumer who on 20-JUN-2008 was vaccinated intramuscularly with a 0.5 mL first dose of GARDASIL vaccine (yeast) (lot # not reported). Concomitant therapy included "birth control pills" (hormonal contraceptives (unspecified)). the patient states that she "experienced stomach pains after getting vaccinated" (onset reported as 22-JUNE-2008). The patient sought unspecified medical attention and provided a urine sample (nor further specified). The patient reported that she was recovering from the stomach pains. Additional information has been requested.
CONFIRMED IMMUNOLOGICAL VACCINE FAILURE; This spontaneous report received from a patient concerned a 69 year old male. Initial information was processed along with the additional information received on 03-AUG-2021. The patient's height, and weight were not reported. No past medical history or concurrent conditions were reported.  The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 1805020 expiry: UNKNOWN) dose was not reported, 1 total administered on 12-MAR-2021 for prophylactic vaccination. No concomitant medications were reported.  On 30-JUL-2021, the patient underwent antibody test which came negative (confirmed immunological vaccine failure). Laboratory data included (on 30-JUL-2021), severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) antibody test (NR, not provided) Negative. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of confirmed immunological vaccine failure was not reported. This report was serious (Other Medically Important Condition).; Sender's Comments: V0: 20210800862 -Covid-19 vaccine ad26.cov2.s-Confirmed immunological vaccine failure. This event(s) is considered not related. 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
Intermittent atrial fibrillation resulting in heart failure with 30 lbs increase in weight in 30 days and peripheral edema.
Information has been received from a physician concerning an approximately 80 year old female with type II diabetes mellitus and asthma who on approximately 11/07/2005 was vaccinated SQ with a 0.5 ml dose of Pneumococcal 23v polysaccharide vaccine (lot # 649914/0578P). Concomitant therapy included an unspecified oral therapy. the physician reported that the patient had been previously vaccinated with a dose of Pneumococcal 23v polysaccharide vaccine (date unknown). Subsequently the patient developed redness, pain and swelling to the arm that was used for Pneumococcal 23v polysaccharide vaccination. Medical attention was sought and the patient received diphenhydramine hydrochloride (Benadryl) and prednisone. Subsequently, the patient recovered from redness, pain and swelling to the arm. The physician considered redness, pain and swelling to the arm to be other important medical events (OMIC). Additional information has been requested.
body ache, fatigue, lower back pain. Body ache and fatigue gone after 2 days. Lower back pain on right side remains.