chrisvoncsefalvay/vaers-outcomes huggingface dataset:
6AUG93 430PM tc from pt stating that 1 hr p/vax pt broke out in rash all over body; rash started @ immun site spread to hairline then to rest of body; pt is itching all over; felt hot, SOB;
Pain swelling and redness at injection site and extending to encompass 5 inchX4inch irregularly shaped section of right upper arm.
Left arm noted with severe redness and swelling on 11/19/04 day after injection given, was seen in local ER-CBC showed WBC 18,000.
EUA -  received injection at 9:50 am on 3/29/21.  Started getting symptoms at 10:00 pm on 3/29/21,  soreness in left arm, body started aching, chills with a fever of 103.3 for about 2 hours.  (Tylenol was taken) was able to get temp down to 99.6.  I took Zofran to prevent nausea . I also had a persistent headache for about 6 hours.  All subsided by 10:00 am the following morning on  3/30/21.  If I cough or sneeze my head hurts but other than that a mild headache.
My arm is kind of swollen in that area; My muscles and arms are so sore; My muscles and arms are so sore; This is a spontaneous report from a contactable consumer. A patient of unspecified age and gender received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, batch/lot and expiration date unknown), via an unspecified route of administration on 07Jan2021 at a single dose for covid-19 immunization. The patient medical history and concomitant medications were not reported. The patient previously took flu shot and experienced muscles and arms were so sore. In Jan2021, the patient experienced arm was kind of swollen in area, and her muscles and arms were so sore. It was further reported that the patient was asking if it was normal because his/her arm was sore where patient had the shot. The outcome of the events was unknown.  Information on the lot/batch number has been requested.
symptoms; Based on the current case data, this case has been classified as invalid. This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION COMPLICATION (symptoms) in a patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No medical history was provided by the reporter.     On 22-Apr-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced VACCINATION COMPLICATION (symptoms). At the time of the report, VACCINATION COMPLICATION (symptoms) outcome was unknown.            No treatment information was reported
pain at injection site; A spontaneous report was received from a healthcare professional concerning a 67-years-old female patient who received Moderna's COVID-19 vaccine (mRNA-1273) and experienced events pain at injection site.  The patient's medical history was not provided. No relevant concomitant medications were reported.  On unknown date, prior to the onset of the events the patient received their first of two planned doses of mRNA-1273 (lot/batch: 004M20A) intramuscularly for prophylaxis of COVID-19 infection. On unknown date, prior to the onset of the events the patient received their second of two planned doses of mRNA-1273 (lot/batch: UNK) intramuscularly for prophylaxis of COVID-19 infection.  On 3 Jan 2021, the patient experienced the event(s) pain at injection site.  Treatment details included Aleve BID self administered.  Action taken with mRNA-1273 in response to the events was not reported.   On 4 Jan 2021 the outcome of event(s), pain at injection site was resolved.
PNEUMONIA; UNABLE TO WALK; SUSPECTED COVID-19 INFECTION; This spontaneous report received from a patient via a company representative concerned a patient of unspecified age and sex. 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, and batch number were not reported) dose was not reported, 1 total, administered on 10-JUL-2021 for prophylactic vaccination. The batch number was not reported and has been requested. No concomitant medications were reported. On 24-JUL-2021, two weeks after vaccination the patient experienced suspected covid-19 infection. The patient then ended up in the hospital two weeks after that with pneumonia and was hospitalized on an unspecified date. The patient reported being out of work on disability, got daily headaches and could not walk a block without being wore out. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from unable to walk, and the outcome of suspected covid-19 infection and pneumonia was not reported. This report was serious (Hospitalization Caused / Prolonged). This report is associated with product quality complaint.; Sender's Comments: V0:20210858943-covid-19 vaccine ad26.cov2.s-Pneumonia. This event is considered unassessable. The event(s) has a compatible/suggestive temporal relationship, is unlabeled, and has unknown scientific plausibility. There is no information on any other factors potentially associated with the event.
prolonged, unconsolable, moderate severe crying >3hr w/in 48hr of vax;? rxn vs viral illness
Very sore shoulder/arm - unable to lift arm above shoulder height.  Lasted about 3-4 days
Information was received from a lawyer regarding a case in litigation concerning a female patient of unknown age. No information was received regarding the patient's past medical history, concurrent conditions, or concomitant medication. The patient was inoculated with ZOSTAVAX on or about 23-DEC-2008, as recommended for routine adult health maintenance for the prevention of shingles (lot number, dosage, and route of administration not provided). The ZOSTAVAX did not prevent shingles as intended, but rather caused the patient to contract a persistent strain of herpes zoster. On or about 10-JAN-2016, the patient was treated by a physician for a vesicular outbreak that was diagnosed as severe shingles. The patient was prescribed acyclovir for management of her painful symptoms. As a direct and proximate result of these malfunctions, the patient suffered painful injuries and damages, and required extensive medical care and treatment. As a further proximate result, the patient has suffered and will continue to suffer significant medical expenses, and pain and suffering, and other damages. Additional information has been requested.
Vaccine administered after temperature excursion; Vaccine administered after temperature excursion; This spontaneous case was reported by an other health care professional and describes the occurrence of PRODUCT STORAGE ERROR (Vaccine administered after temperature excursion) and EXPIRED PRODUCT ADMINISTERED (Vaccine administered after temperature excursion) in a 33-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 003B21A) for COVID-19 vaccination.     The patient's past medical history included No adverse event (No reported medical history).    On 02-Apr-2021, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 02-Apr-2021, the patient experienced PRODUCT STORAGE ERROR (Vaccine administered after temperature excursion) and EXPIRED PRODUCT ADMINISTERED (Vaccine administered after temperature excursion). On 02-Apr-2021, PRODUCT STORAGE ERROR (Vaccine administered after temperature excursion) and EXPIRED PRODUCT ADMINISTERED (Vaccine administered after temperature excursion) had resolved.        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.   Concomitant product use was not provided by the reporter.  Treatment information was unkown.
Vomiting, lightheaded, very weak. Started Saturday, better Sunday, pain left side, throat was swollen.
(7/3/2021) Dry strong Cough, treated for Pneumonia with Azithromycin , muscle relaxant and after 5-6 days feeling better. Returned to work on 7th and was done with the course by 7/10/2021
INTENSE ACHES, AND CHILLING, ACHES BEGAN A FEW HRS AFTER INJECTION, CHILLING AND TEMP ELEVATION TO 100.5 OCCURRED AT APPROX 10:00PM, AND LASTED FOR 90 MINUTES. OK NEXT AM EXCEPT 4 ALL OVER MUSCLE ACHES FROM INTENSE CHILLING.
Information has been received from a RN concerning a 5 yr old male who in Nov 2001, was vaccinated with a dose of varicella virus vaccine live. In Feb 2005, the pt developed a full blown case of chickenpox that resulted in encephalopathy. Medical attention was sought. He was hospitalized, treated (unk measures) and recovered completely. There was no product quality complaint involved. The pt's varicella that resulted in encephalopathy was considered to be an other important medical event (OMIC). Additional information has been requested.
Around 8pm after the injection I started feeling nausea's, dizzy, general feeling, body aches, and trouble moving around.  I missed a day of work but two days after I was fine.
Systemic: Fainting / Unresponsive-Mild, Additional Details: Patient was alert, normal vitals, BP 121/80
Symptoms started 14 hours post vaccination Dizziness  and inability to stand or sit for more than 2-3 mins. Lasted for 1.5 days Blurred vision Chills Nausea for few days and vomiting 14 hour post vaccination Swelling of lymph nodes in the same arm of injection for 3 days Migraine like headaches for 6 days. Bruise at injection site ( 2 inches in length and 1.5 inches wide) for 6 days Fatigue for 6 days
developed symptoms of covid; This spontaneous case was reported by a consumer and describes the occurrence of SUSPECTED COVID-19 (developed symptoms of covid) in a 65-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On 03-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 09-Feb-2021, the patient experienced SUSPECTED COVID-19 (developed symptoms of covid). The patient was treated with GUAIFENESIN (MUCINEX) at an unspecified dose and frequency. At the time of the report, SUSPECTED COVID-19 (developed symptoms of covid) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 15-Feb-2021, SARS-CoV-2 test (positive-negative): positive.     The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No relevant concomitant medications were reported. Treatment details included musinax, deliquel.
4 hours post injection: chills, sweats, body and muscle aches, headache, fatigue. All subsided 48 hours later except for the muscle aches, consistent nagging headache, and serious fatigue. That has continued 1 month to date from when I received the first shot. I did not received the second dosage at my providers direction.
Pt received Zostavax on 11/17/06 on 11/17/06 she developed an Arthus reaction at the injection site.
1 year old vaccines given on 8/19/13. Started running fever, 101.2 rectal, on 8/26 took to the doctor on 8/27/13. Diagnosed with strep throat and ear infection. Placed on antibiotics. Rash noted on 8/28/13. Mom in clinic on 8/30/13 complaints of child's rash. Took child to ER 8/31/13 for crying and rubbing mouth. Diagnosed with scarlet fever and scarlet rash. 9/13/13 - rash dissipated and afebrile.
Rash on the back, chest and on top of head fever, chills, muscle aches, fatigue, swollen lymph nodes. Pt has been hospitalized for three days. Doctor plans to keep him for two more days. Doctor diagnosed as generalized vaccinia reaction. Recovering, not yet full recovery.
Symptoms started on 1/23/13, patient felt feet were swollen and itchy. Patient noticed hands were swollen and itchy 1/24/13, also with urticaria on neck, legs, and trunk treated with BENADRYL and ibuprofen at home prescribed prednisone 20 mg 1 tab BID x 5 days of visit on 1/25/13.
Thursday pm pt started having rash to cheeks and fever. Friday broke out with full bodied rash, went to ER, was told it was vaccine allergic reaction. Given rx for benadryl and to F/U with PCP if not better. Called incident in this AM still noted
Redness and swelling, pain and itchiness around local area of injection: 10.5 x 15 cm area on (L) thigh. Improvement with BENARDYL and ice. No fever. Normal mobility.
Pain and redness in right thigh went to ER and Tx for cellulitis. Given Cleocin susp.
No adverse reaction, patient came to vaccine clinic, filled out consent marking no to any previous COVID vaccination, previous COVID vaccine on March 5th 2021. Patient was given vaccine according to consent and check list.
pt recvd vax;exp flu like illness w/ fever,transient sore throat & watery nose;to MD;
Pain at injection site, tired and weak, shivering, fever, Upset stomach and throwing up
No other AEs or PQC reported; immunocompetent patient received PNUEMOV AX 23 vaccine 9/18/2019 and again on 10/5/2021.; immunocompetent patient received PNUEMOV AX 23 vaccine 9/18/2019 and again on 10/5/2021.; This spontaneous report was received from a pharmacist referring to a 51 years old male patient. Information about medical history, concurrent conditions and concomitant therapies was not provided.    On 18-SEP-2019, the immunocompetent patient was vaccinated with pneumococcal vaccine, polyvalent (23-valent)(PNEUMOVAX23), 0.5 milliliter, intramuscular for prophylaxis. On 05-OCT-2021, the patient was vaccinated with pneumococcal vaccine, polyvalent (23-valent)(PNEUMOVAX23), 0.5 milliliter, intramuscular again (product use issue, inappropriate schedule of product administration). No adverse event was reported.
This spontaneous report as received from a medical assistant refers to unspecified patients of unknown age and gender. The patient's pertinent medical history, current conditions and concomitant medications were not reported. On an unknown date the patients were vaccinated with improperly stored M-M-R II lot # K024825 expiry date: 02-DEC-2016, 0.5 ml, subcutaneously. No adverse effects were reported. There was no product quality complaint involved. This is one of the two reports received from the same reporter. Additional information has been requested.
Twelve-year-old patient was inadvertently given pediatric Pfizer BioNTech which is indicated for ages 5-11.
patient has Diabetes; High Cholesterol; Thyroid problems; received 1st dose of Engerix B in 2010 and did not complete the series yet; This case was reported by a pharmacist via call center representative and described the occurrence of diabetes in a adult male patient who received HBV (Engerix B) for prophylaxis.   Co-suspect products included HBV (Engerix B) for prophylaxis.   On an unknown date, the patient received the 1st dose of Engerix B and the 2nd dose of Engerix B. On an unknown date, more than 2 years after receiving Engerix B and not applicable after receiving Engerix B, the patient experienced diabetes (serious criteria GSK medically significant), blood cholesterol increased, thyroid disorder and incomplete course of vaccination. On an unknown date, the outcome of the diabetes, blood cholesterol increased, thyroid disorder and incomplete course of vaccination were unknown.   It was unknown if the reporter considered the diabetes, blood cholesterol increased and thyroid disorder to be related to Engerix B.  Additional details were reported as follows: The age at vaccination was not reported. The patient received the 1st dose of Engerix B in 2010.  The reporter stated that the patient had diabetes, thyroid problems and high cholesterol but was not aware if these conditions were prior to dose 1 of Engerix B. The reporter consented to follow up. All patient identifiers were reported, no batch number or expiration date reported when asked.  The patient received the 1st dose in 2020 and did not complete the series till the time of reporting which led to incomplete course of vaccination. The reporter asked should they have to revaccinate or administering 2nd and 3rd dose would be ok.
My dad woke up this morning with partial hearing loss to his right ear.  Other normal symptoms he has is back pain and a little small rash at injection site.
became immed lightheaded & dizzy p/vax;observed x 30min in occupational hlth services office w/no other adverse affects;
Information has been received from an office manager referring to an unspecified patient of unknown age and gender. The patient's pertinent medical history and drug reactions/allergies were not reported. On 24-JUN-2016, the patient was inadvertently vaccinated with an expired dose of RECOMBIVAX HB (5/0.5 microgram/ml, second dose, lot # K011239 with expiry date 11-JUN-2016), intramuscularly. Concomitant medication was not reported. No adverse effects were reported. Additional information has been requested.
Not feeling well; Felt like he was freezing; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). Other Case identifier(s): UNT-2022-024370 (Company).  An 87-year-old male patient received BNT162b2 (BNT162B2), as dose number unknown, single (Batch/Lot number: unknown) for covid-19 immunisation; treprostinil sodium (TYVASO), since 07Jan2022 (Lot number: 2102227, Expiration Date: 30Nov2023) at 12 ug 4x/day for pulmonary arterial hypertension. The patient's relevant medical history included: "Pulmonary arterial hypertension" (ongoing). Concomitant medication(s) included: ELIQUIS; DILTIAZEM HYDROCHLORIDE. The following information was reported: MALAISE (non-serious), outcome "unknown", described as "Not feeling well"; FEELING COLD (non-serious), outcome "unknown", described as "Felt like he was freezing". The action taken for treprostinil sodium was unknown.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Swelling in left arm and leg; pain in left knee; This spontaneous case was reported by a consumer and describes the occurrence of PERIPHERAL SWELLING (Swelling in left arm and leg) and ARTHRALGIA (pain in left knee) in a 66-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 047A21A and 036A21A) for COVID-19 vaccination.     Concomitant products included LOSARTAN for Blood pressure.   On 13-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 10-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On an unknown date, the patient experienced PERIPHERAL SWELLING (Swelling in left arm and leg) and ARTHRALGIA (pain in left knee). At the time of the report, PERIPHERAL SWELLING (Swelling in left arm and leg) and ARTHRALGIA (pain in left knee) outcome was unknown.            No treatment information provided.
COVID positive; COVID positive; This is a spontaneous report from a contactable consumer (patient). A 69-years-old (non-pregnant) female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Lot Number: EN6205), dose 1 via an unspecified route of administration, administered in arm left on 01Mar2021 at 04:00 as single dose for COVID-19 immunization. Medical history included rheumatoid arthritis. Concomitant medication(s) included methotrexate. The patient did not receive any other vaccine in four weeks. The patient did not had COVID prior vaccination. On 14Mar2021, the patient experienced COVID positive. On 14Mar2021, the patient underwent lab tests and procedures which included nasal swab positive. Therapeutic measures were taken as a result of COVID positive included monoclonal infusion. The outcome of event was recovered with sequelae.
Swelling at injection site. Welt looked like a bullseye. Swelling went into axillary lymph nodes and into the right breast and down the right arm.
Systematic, lose nasal congestion and wet cough. Full two weeks and stayed home longer.
Systemic: Nausea-Severe, Systemic: Seizure-Severe
Swelling in both wrist, itching on palms of hands and soles of feet. Welts on hip bones and on one breast.
Pt recv vax on 4/1/98; within 24 hrs pt exp 6x6 cm swollen, red, hot injection site on thigh.  Pt able to walk w/o noticeable pain.
heart was racing i just felt like I was going to die; both eyes were really puffy; had a sore throat; pain in deltoid muscle; This case was received via an unknown source (no reference has been entered for a health authority or license partner) on 02-Feb-2021 and was forwarded to Moderna on 03-Feb-2021.    This spontaneous case was reported by a consumer and describes the occurrence of PALPITATIONS (heart was racing i just felt like I was going to die), PERIORBITAL SWELLING (both eyes were really puffy), OROPHARYNGEAL PAIN (had a sore throat) and VACCINATION SITE PAIN (pain in deltoid muscle) in a 65-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 013L20A) for COVID-19 vaccination.     The patient's past medical history included Heart attack. Concurrent medical conditions included Diabetes.    On 21-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 22-Jan-2021, the patient experienced VACCINATION SITE PAIN (pain in deltoid muscle). On an unknown date, the patient experienced PALPITATIONS (heart was racing i just felt like I was going to die), PERIORBITAL SWELLING (both eyes were really puffy) and OROPHARYNGEAL PAIN (had a sore throat). The patient was treated with ASPIRIN [ACETYLSALICYLIC ACID] for Adverse event, at an unspecified dose and frequency and EMERGEN C for Adverse event, at an unspecified dose and frequency. At the time of the report, PALPITATIONS (heart was racing i just felt like I was going to die), PERIORBITAL SWELLING (both eyes were really puffy), OROPHARYNGEAL PAIN (had a sore throat) and VACCINATION SITE PAIN (pain in deltoid muscle) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Concomitant product information was not provided.  Treatment also included an unspecified antihistamine. Reportedly, the patient was feeling better after treatment medications.   Reporter did not allow further contact   Most recent FOLLOW-UP information incorporated above includes: On 02-Feb-2021: Major narrative update: treatment information correction. On 21-Jul-2021: Follow-up received 21-Jul-2021 included no new information.
Approximately a minute to three minutes I started having burning sensation in both arms and legs and next having ringing in my ears and started to get dizzy and feel like I?m going to pass out. Sat down became very pale and started sweating profusely. Approximately 15 to 20 minutes symptoms has decreased but felt very fatigue. Went to the fire department approximately 30 minutes after symptoms decrease and fire apartment was unable to clarify  why I had these symptoms The following day 9/19/2021 when doing light activities I had  chest pain 5/10 pain and shortness of breath and thought fatigue and lightheaded.  Went to the fire apartment had slight elevation of blood pressure and heart rate. Three days  9/20/2021  I was on a stationary  bicycle with light resistance  I had chest pain and shortness of breath  and felt dizzy and ringing in the ears blood pressure was 177/86. Went to the fire department the   Fire department  took my blood pressure it was 164/83 and heart rate was 112bpm. They EKG came out normal. Still having chest pains shortness of breath and fatigue with normal activities and with any slight exertion blood pressure goes up and increase chest pain. I have seen allergy doctor that recommended the Covid vaccine and he referred me to a cardiac doctor.   ?Allergy doctor ?stated that I had a reaction and does not recommend me having second dose.