chrisvoncsefalvay/vaers-outcomes huggingface dataset:
tingling; 1-1/2 inch red and swollen circle at injection site which was warm to touch; 2 by 1-1/2 inch red and swollen circle at injection site which was warm to touch; 1-1/2 inch red and swollen circle at injection site which was warm to touch; This spontaneous case was reported by a nurse (subsequently medically confirmed) and describes the occurrence of VACCINATION SITE PARAESTHESIA (tingling), VACCINATION SITE WARMTH (1-1/2 inch red and swollen circle at injection site which was warm to touch), VACCINATION SITE SWELLING (2 by 1-1/2 inch red and swollen circle at injection site which was warm to touch) and VACCINATION SITE ERYTHEMA (1-1/2 inch red and swollen circle at injection site which was warm to touch) in a 69-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 039K20A) for COVID-19 immunization.     No Medical History information was reported.    On 30-Dec-2020, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 08-Jan-2021, the patient experienced VACCINATION SITE PARAESTHESIA (tingling), VACCINATION SITE WARMTH (1-1/2 inch red and swollen circle at injection site which was warm to touch), VACCINATION SITE SWELLING (2 by 1-1/2 inch red and swollen circle at injection site which was warm to touch) and VACCINATION SITE ERYTHEMA (1-1/2 inch red and swollen circle at injection site which was warm to touch). At the time of the report, VACCINATION SITE PARAESTHESIA (tingling), VACCINATION SITE WARMTH (1-1/2 inch red and swollen circle at injection site which was warm to touch), VACCINATION SITE SWELLING (2 by 1-1/2 inch red and swollen circle at injection site which was warm to touch) and VACCINATION SITE ERYTHEMA (1-1/2 inch red and swollen circle at injection site which was warm to touch) was resolving.        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.   Concomitant product use was not provided.  The patient had a two by one and a half inch red and swollen circle at the injection site which was warm to touch days after receiving the vaccine. The reporter stated the side effects are not getting worse but seem to be subsiding. She said there was less tingling. Treatment information was not provided.  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.   Reporter did not allow further contact; Sender's Comments: 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.
pt recv vax 14MAR96 & 2JAN98 pt exp some small spots & was seen by a MD on 5JAN98 & returned to MD w/a rash consisting of more than 300 to 400 macular papular lesions from buttocks up to trunk;
0.25mL dose administered accidentally for a first dose; Based on the current case data, this case has been classified as invalid. This spontaneous case was reported by a nurse and describes the occurrence of ACCIDENTAL UNDERDOSE (0.25mL dose administered accidentally for a first dose) 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) (unknown route) .25 ml. On an unknown date, the patient experienced ACCIDENTAL UNDERDOSE (0.25mL dose administered accidentally for a first dose). At the time of the report, ACCIDENTAL UNDERDOSE (0.25mL dose administered accidentally for a first dose) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant medications were reported. No treatment information were reported.  The nurse thought the vaccine administered to the patient was a booster dose, but after administration, the patient reported this was the patient's first dose.
Severe rash, hives on entire body (except face). Swollen feet, ankles hot to touch. 2 days of mild fever.
August 15 - large red patch on left arm at injection site (9 days after vaccine) went away within 48 hours August 23 - large red circular patch on upper right breast (17 days after vaccine) went away within 48 hours - this is the symptom I am concerned about. I had a breast aug in March 2020 and when this spot appeared I thought that there could be an infection in the implant (even though that would be very rare) - The surgeon saw photos and wanted to see me immediately to rule out infection. He was not able to figure out why I had this rash/inflammation. Very similar to the one I had on my arm the week before, but I can't find any research on anyone facing similar symptoms.
fever 102f, chills, headache, body aches, joint pain leg hip, injection site pain
These symptoms were unlike what was experienced for the first and second doses resulting in much discomfort; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP).  A 58 year-old female patient (not pregnant) received bnt162b2 (BNT162B2) (Batch/Lot number: unknown) at the age of 58 years as dose 1, single and (Batch/Lot number: unknown) as dose 2, single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: DISCOMFORT (non-serious), outcome "unknown", described as "These symptoms were unlike what was experienced for the first and second doses resulting in much discomfort".  Additional information: Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information was expected.
Immediately after receiving vaccination my lips went numb.  About 20 minutes later my lips were better but my face went numb all below the eye area and nose got cold.  Below the eyes is still a tingly numb which is now over 48 hours later.
fever 99.9; 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 PYREXIA (fever 99.9) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. unk) for COVID-19 vaccination.     No Medical History information was reported.    On 26-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 27-Feb-2021, the patient experienced PYREXIA (fever 99.9). At the time of the report, PYREXIA (fever 99.9) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 27-Feb-2021, Body temperature: 99.9 (High) fever 99.9.     The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No Concomitant medications were reported. No Treatment information was reported.   Reporter did not allow further contact
Patient reports pruritic rash, by report consistent with "Covid Arm", that developed ~7 days after immunization. Resolved on it's own after a day or two. No other sequelae noted.
MMR vaccine given on 9/23/11 - 2 weeks later 10/16 11 seen in our office with rash on face, trunk, chest, buttocks and all 4 extremities - (worsening over the 2 weeks after vaccine). BENADRYL helped relieve sx.
About 12 hours after vaccine, patient felt very dizzy and felt like she was going to pass out. She lowered herself to the floor and felt a a wave of nausea. Patient was very pale and weak. Event lasted 6 minutes and did not occur again.
One of five pt (B/W JUL-AUG 1990) experienced inject site rxn which included erythema & swelling, tx included ice packs @ site of inject & Tylenol PRN. Pt afebrile.
Mother reportd that the child had woke up from his nap after lunch on 10/28/09 crying, complaining of pain in his leg where shot was given. He was pale, extreme irritability, lack of appetite. Later, stated his leg don't work. No fever, mother informed muscle ache is S/E. 10/30/09 mother stated child much better today.
Pt recvd 2 doses of Engerix-B (APR & MAY91) & SEP91 exp blurred vision & changes in vision; pt has seen a MD & had glasses prescribed; however, pt vision continues to change so that glasses are not effective; events have not resolved;
BODY ACHES; LOSS OF APPETITE; DYSPEPSIA; UPPER CHEST DISCOMFORT; SORE THROAT; CHILLS; NAUSEA; SHAKING; This spontaneous report received from a health care professional concerned a 32 year old female. The patient's height, and weight were not reported. The patient's concurrent conditions included iodine allergy, personality disorder, alcohol dependence, opioid dependence, seizure, and adjustment disorder.The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, and batch number: 1805025 expiry: UNKNOWN) dose was not reported, administered on 12-APR-2021 for prophylactic vaccination. No concomitant medications were reported. On 12-APR-2021, the subject experienced shaking. On 12-APR-2021, the subject experienced chills. On 12-APR-2021, the subject experienced nausea. On 13-APR-2021, the subject experienced body aches. On 13-APR-2021, the subject experienced loss of appetite. On 13-APR-2021, the subject experienced dyspepsia. On 13-APR-2021, the subject experienced upper chest discomfort. On 13-APR-2021, the subject experienced sore throat. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from body aches, loss of appetite, dyspepsia, nausea, chills, shaking, upper chest discomfort, and sore throat. This report was non-serious. This case, from the same reporter.
Have had substantial shortness of breath--as though I've completed a strenuous workout--for two days now. Even though I have kept my activity minimal and have avoided working out since the onset of shortness of breath.
Rash; Nausea; Shivering; This case was reported by a consumer and described the occurrence of rash in a 89-year-old male patient who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included Shingrix with an associated reaction of rash (1st dose received on an unknown date, reference case US2020AMR244350).   On 8th December 2020, the patient received the 2nd dose of Shingrix (intramuscular). On 8th December 2020, less than a day after receiving Shingrix, the patient experienced rash, nausea and shivering. Rechallenge with Shingrix was positive. On an unknown date, the outcome of the rash, nausea and shivering were unknown.   It was unknown if the reporter considered the rash, nausea and shivering to be related to Shingrix.  Additional details were provided as follows: The patient had reported the case for himself. The patient experienced shivering, nausea, and rash that occurred after receiving the vaccine. The patient had rash after the first dose of Shingrix, but did not believe it was related to the vaccine at the time. All information was not available. The patient did want his physician contacted, but did not know the phone number. The reporter did not consent to follow-up.; Sender's Comments:  US-GLAXOSMITHKLINE-US2020AMR244350:Same reporter
Burning pain in my body; This non-serious case was reported by a consumer via interactive digital media and described the occurrence of pain burning in a patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   On an unknown date, the patient received Shingles vaccine. On an unknown date, an unknown time after receiving Shingles vaccine, the patient experienced pain burning (Verbatim: Burning pain in my body). The outcome of the pain burning was not recovered/not resolved.   It was unknown if the reporter considered the pain burning to be related to Shingles vaccine.     It was unknown if the company considered the pain burning to be related to Shingles vaccine.   Additional Information: GSK receipt date: 13-Mar-2023 The case was received from the patient via interactive digital media. The patient stated that they administered the shot and the burning pain in his/her body started. The patient was fine before they injected him/her 5 days ago, let's see when they go away. The follow-up could not be possible as no contact details were available. As per reported information it seems that the patient still experiencing burning pain and wait for it's recovering, therefore conservatively outcome was captured as not recovered.
Patient reports neck pain and rigidity approximately 24 hours following vaccine administration.  Patient states the issue has not resolved or improved.
Sore arm, rash at injection site, warm skin at injection site, lump at injection site.
p/vax pt devel fever as highas 106 & had a sz;hosp x 4 days;tx ATB;child has a cycle of spiking a fever every 3-4 wk since March;exp another fever & sz to ER;seen by allergist & several other specialists;
Got shingles after my 2nd jab/Suspected vaccination failure; Shingles; 15 months of pain; This case was reported by a consumer via interactive digital media and described the occurrence of vaccination failure in a patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   Co-suspect products included Herpes zoster (Shingles vaccine) for prophylaxis.   On an unknown date, the patient received the 2nd dose of Shingles vaccine and the 1st dose of Shingles vaccine. On an unknown date, unknown after receiving Shingles vaccine and Shingles vaccine, the patient experienced vaccination failure (serious criteria GSK medically significant), shingles and pain. On an unknown date, the outcome of the vaccination failure and shingles were unknown and the outcome of the pain was recovered/resolved.   It was unknown if the reporter considered the vaccination failure, shingles and pain to be related to Shingles vaccine and Shingles vaccine.     Additional Information: GSK Receipt Date: 09-SEP-2022 Reporter's Comment: This case was reported by the patient via interactive digital media. The patient got shingles after his/her 2nd Shingles vaccine in the same arm. Patient had pain for 15 months. Additional supportive information: This case was considered as suspected vaccination failure as details regarding time to onset for shingles and laboratory confirmation regarding shingles were unknown at the time of reporting. Follow-up would not possible as no contact details were available.
No feeling in hands and feeling Severe swelling in feet with rash on foot. Measle like symptoms. Dizziness with lying down. Off balance. Trouble breathing.  Severe fatigue and muscle weakness. All these symptoms were with second shot. Put on antibiotics. Put on higher doses of steriod (50ml of Corteff a day). Steriods calm everything down. Still didn't get feeling back in feet and hands. Received booster on Oct 5 (Lot #047C21A, IM, LA) All symptoms came back and were more severe.  Currently still expirencing severe fatique, numbness in arm, hands, legs, and feet, and shortness of breath, and dizziness, and being off balance.  Doctors :Primary care, cardiologist, pulmonologist
14MAY h/a, dizzy, t103.2 mom gave APAP t102 650AM; had sz (on Phenobarb took to ER); MD found fluid in ears bilaterally, placed on amoxicillin; h/a, dizziness, stiff neck cont temp;
It was discovered that the pharmacist administering the vaccine on 10/21/22 had improperly diluted the vaccine resulting in a higher than recommended dose due to improper dilution. The patient and primary care physician were contacted. The patient's mom has said no adverse event has occurred so far to her knowledge. The patient seems like she has a cold today if anything.
COVID 19 Treatment; COVID 19 Treatment; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP) from product quality group. The reporter is the patient.  A 70-year-old female patient (not pregnant) received BNT162b2, BNT162b2 Omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), on 12Sep2022 as dose 5 (booster), single (Lot number: GH9694) at the age of 70 years, in left arm for COVID-19 immunization; BNT162b2 (BNT162B2), on 29Apr2022 as dose 4 (booster), single (Lot number: FK9894), in left arm for COVID-19 immunization; coviD-19 vaccine (COVID-19 VACCINE), as dose 1, single (Batch/Lot number: unknown), as dose 2, single (Batch/Lot number: unknown) and as dose 3 (booster), single (Batch/Lot number: unknown) for COVID-19 immunization. The patient's relevant medical history included: "Chronic hepatitis B" (unspecified if ongoing); "Penicillin allergy" (unspecified if ongoing). Concomitant medication(s) included: LEVOTHYROXINE; LISINOPRIL; TENOFOVIR. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant), outcome "unknown" and all described as "COVID 19 Treatment". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (11Nov2022) Positive, notes: Tested positive using test on 11Nov2022; (unspecified date) Positive, notes: Indication=Treatment of COVID-19. Therapeutic measures were taken as a result of drug ineffective, COVID-19.  Additional information: Other Medication Details: Tenofovir, Lisinopril, and Levothyroxine.
Pt recv vax on 10/21/98; 4 hr post vax pt exp tight chest, cough, fatigue & body aches
arm pain 7-10 days fever 102 3-4 days headache extreme joint pain - all 5-6 days fatigue
flu like symptoms; very bad diarrhea; fever; chills; This spontaneous case was reported by a consumer and describes the occurrence of INFLUENZA LIKE ILLNESS (flu like symptoms), DIARRHOEA (very bad diarrhea), PYREXIA (fever) and CHILLS (chills) in a 69-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 036A21A) for COVID-19 vaccination.     No Medical History information was reported.    On 16-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced INFLUENZA LIKE ILLNESS (flu like symptoms), DIARRHOEA (very bad diarrhea), PYREXIA (fever) and CHILLS (chills). The patient was treated with ACETYLSALICYLIC ACID (ASPRIN) at an unspecified dose and frequency. At the time of the report, INFLUENZA LIKE ILLNESS (flu like symptoms), DIARRHOEA (very bad diarrhea), PYREXIA (fever) and CHILLS (chills) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Concomitant product use was not provided by the reporter.
Shingles; This is a spontaneous report from a contactable consumer, the patient. A 27-year-old male patient received the second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: UNKNOWN) via an unspecified route of administration on an unknown date as a single dose for COVID-19 immunisation. Medical history and concomitant medications were 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. On 14Apr2021 at 21:00, a little over after 48 hours after the 2nd dose of the vaccination,  the patient began to show symptoms of shingles. The patient was then diagnosed with shingles a day later. Therapeutic measures were taken as a result of adverse events and included treatment with VALTREX. The events resulted in doctor or other healthcare professional office/clinic visit.  Since the vaccination, the patient had not been tested for COVID-19.  The clinical outcome of the event shingles was recovering at the time of this report.   No follow-up attempts are needed; information about lot/batch number cannot be obtained.
Vaccine failure - H. influenzae Sepsis; This case was identified by a surveillance study.
I am an internal medicine provider and have an 18-year h/o rheumatoid arthritis that had been well-controlled for years allowing me to stop treatment with MTX/leucovorin 3 years ago.   On 2/28/021 I developed pain, erythema, warmth and swelling at the 4th MCP in my L hand which persisted for several days.  I contacted my rheumatologist, and saw him on 03/04.  Since this was my first episode of inflammation in years, we elected to treat it conservatively with naproxen OTC.  My symptoms resolved after several days, but then I had successive episodes of pain, erythema, warmth and swelling in my R 5th MCP, R ankle, L 5th TMT, L 5th MCP, L knee and R wrist over the next 3 weeks--- in the pattern of palindromic rheumatism similar to that my symptoms had first began 18 years ago.  Given the number and severity of these episodes, doctor recommended treatment with prednisone 10mg PO qdaily for 30 days and restarting MTX 15mg (six 2.5mg tabs) PO qweekly  and folate 1mg PO qdaily.
Patient complained of itchiness at site of injection which spread to left side of his body. Today he said it was all over and he had hives everywhere.  When asked if there was any trouble breathing, he said no.
Noticed collar bone started hurting approximately 24 hours after receiving the booster vaccination.  Felt tender.  Monday, early afternoon, pain has increased slightly, and noted a swollen lymph node.  The collar bone is on the side where the vaccine was received.
Tachycardia the day of vaccination, chills and fatigue. Red Hot skin patch at the injection site 2 days after, suspecting cellulitis -> recommended F/U with PCM or Urgent care.
Initial information received on 10 October 2014 from a consumer. The reporter for this case also reported another event which is captured in case 2014SA140898. An unidentified patient was administered on an unspecified date a dose of FLUZONE QIV, (batch number: UI192AA) route and site of vaccination not reported. The patient's medical history and concomitant medications were not reported. On an unspecified date, the patient experienced cellulitis. The patient required an ER/doctor visit on an unreported date. Corrective treatment and laboratory investigations were not reported. The reporter considered the event life threatening. At the time of this report, the outcome of the event was reported as unknown. No further details were available at the time of this report. Documents held by sender: none.
This case was reported by a pharmacist via call center representative and described the occurrence of injection site warmth in a 72-year-old female patient who received SHINGRIX (batch number EH9Z7, expiry date 8th March 2021) for prophylaxis. On 27th September 2018, the patient received the 2nd dose of SHINGRIX (subcutaneous). On 28th September 2018, 1 days after receiving SHINGRIX, the patient experienced injection site warmth, injection site induration and injection site swelling. On an unknown date, the patient experienced intramuscular formulation administered by other route. On an unknown date, the outcome of the injection site warmth, injection site induration, injection site swelling and intramuscular formulation administered by other route were unknown. It was unknown if the reporter considered the injection site warmth, injection site induration and injection site swelling to be related to SHINGRIX. Additional information was reported as follows: The patient was inadvertently vaccinated with SHINGRIX by subcutaneous route instead of intramuscular route, which led to intramuscular administered by other route. The morning after vaccination with SHINGRIX, the patient noticed injection swelling, injection site warmth and hardness at injection site.
Pt experienced an injection site reaction characterized by pain, redness and swelling. Pt also experienced decreased appetite and felt tired.
PT. RECEIVED DapTCELL VACCINE IN L. DELTOID. AFTER 48 HRS., PT RETURNED TO OFFICE TO HAVE PPD READ & PARENT STATED INJ. SITE OF DapTCELL BECAME RED, SWOLLEN, & WARM TO THE TOUCH. ON EXAM, ARM WAS NO LONGER SWOLLEN, ONLY SLIGHTLY PINK, NOT PAINFUL OR WARM TO TOUCH.THIS WAS 1ST.\ DOSE WITH DAPTACEL-PREVIOUS IMM.WITH TRIPEDIA.