chrisvoncsefalvay/vaers-outcomes huggingface dataset:
On 08/29/2022, I woke up with a runny nose. Later in the morning, I developed a slight fever of 100.5. I took some Tylenol, and the fever only lasted a total of around 6 hours. I took an at home COVID-19 test, and it was positive. I never had to take any additional Tylenol. My only symptoms were that short lived fever and a runny nose. The only reason I tested myself and discovered that I was positive was because I had a wedding to attend. The runny nose lasted for around 5 days. I continued testing myself and was still positive at 5 days. I tested again at 7 days and was negative. I took an additional test on the 9th day, and it was also negative. I continued to isolate at home for the additional day for a total of 10 days.
Initial information was received from a health professional on 16 September 2008. A two month old female patient with no reported past medical history developed a rash five days post vaccination after she received a first dose injection of ACTHIB lot number UF366A (sanofi pasteur SA lot number A0802-2), IPOL (lot number A0996-2), IPOL (lot number A0996-2) administered in the left deltoid, PREVNAR (manufacturer Wyeth, lot number C54766) administered in the right thigh, HEPATITIS B (manufacturer Merck, lot number 0574Y) administered in the right thigh, and ROTATEQ (manufacturer Merck, lot number 0281Y) administered orally. The vaccines were all administered on 03 July 2008. On 08 July 2008 the patient developed a "red and raised" rash on her chest, arms, and legs. The patient did not have a fever or any other symptoms. The patient's recovery status was unknown at the time of the event. This case is linked to case number 2008-02906.
Testicular pain 15 minutes after receiving shot. Moderate testicular pain/inflammation continues for next 12 days. Currently experience pain in scrotum area.
sick; COVID positive; 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 ILLNESS (sick) and SARS-COV-2 TEST POSITIVE (COVID positive) in a patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. unknown) for COVID-19 vaccination.     No Medical History information was reported.    On an unknown date, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage form. On an unknown date, the patient experienced ILLNESS (sick) and SARS-COV-2 TEST POSITIVE (COVID positive). At the time of the report, ILLNESS (sick) and SARS-COV-2 TEST POSITIVE (COVID positive) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No treatment mediation were reported.  Patient informed that he had  sick for 9days he think he had covid  will a test so a positive reading now that he is better.
The second dose was given 3 days before the 4 day grace period for second dose of Moderna covid19.  First dose was 4/13/21 and second was 5/4/21.   Patient had returned 1 week before scheduled appointment.  Discovery of error was after administration on  5/4/21.  Patient was still in pharmacy and was notified of the error.
no adverse event; in advertanly gave a moderna bivalent vaccine 4 days after 30 day window; This spontaneous case was reported by a pharmacist and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (in advertanly gave a moderna bivalent vaccine 4 days after 30 day window) and NO ADVERSE EVENT (no adverse event) in a 46-year-old patient of an unknown gender who received mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (batch no. AS7171B) for COVID-19 prophylaxis.     No Medical History information was reported.    On 14-Feb-2023, the patient received dose of mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (unknown route) 1 dosage form. On 14-Feb-2023,  after starting mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)), the patient experienced EXPIRED PRODUCT ADMINISTERED (in advertanly gave a moderna bivalent vaccine 4 days after 30 day window). On an unknown date, the patient experienced NO ADVERSE EVENT (no adverse event). At the time of the report, EXPIRED PRODUCT ADMINISTERED (in advertanly gave a moderna bivalent vaccine 4 days after 30 day window) and NO ADVERSE EVENT (no adverse event) outcome was unknown.        For mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (Unknown), the reporter considered NO ADVERSE EVENT (no adverse event) to be not related. No further causality assessment was provided for EXPIRED PRODUCT ADMINISTERED (in advertanly gave a moderna bivalent vaccine 4 days after 30 day window).    No concomitant medications was provided. No treatment medications was provided.
Worker applied syringe into patients LD to administer vaccine. When pushing the plunger down, it stopped half way. Worker removed needle from patient, discarded it into the sharps container and grabbed a supervisor. The supervisor grabbed the head RN and the head RN called the head doctor for medical direction. Doctor ordered that because the dose that was administered was only half, it was safe to administer a full dose in the other arm. Once the worker got permission from his supervisor and head RN, the worker administered a full dose of the vaccine to the patients RD.
Rash on thighs, chest, abdomen. Feeling of throat swelling. Dexamethasone ordered.
Heaviness and tingling in bilateral arms. No other symptoms. She was monitored for a total of 60 minutes. No decrease or increase in feeling. She called her mother to come and pick her up.  She was escorted out of the clinic walking.
The patient's throat was tingling after administration, with not other side effects.  Issue resolved on its own.
Patient developed extreme fatigue 2 days following the COVID vaccine which caused a clinical relapse of MS.  No new radiographic lesions, but patient was/is much weaker than baseline.
The client was given 0.2 ml of the Pfizer peds that had not been diluted with the 1.3ml of Normal Saline,   parents where informed,  reviewed signs to watch child for- Check on child 4 hours after incident- he is not having any adverse symptoms.
Received flu shot and BEXSERO 9/3/2015. 9/7-9/8-generalized myalgias/chills-went away. 9/9-generalized body paresthesias, "prickliness" diminishing but not gone. 9/10-sore upper neck and red eye (L).
Nausea, sweating, pale. Given water and crackers. BPs 142/78 (pulse 75), 144/76 (pulse 74), O2 sat 100%.
FATIGUE; NAUSEA; TEMPERATURE OF 100.6F; This spontaneous report received from a patient via a company representative concerned a female of unspecified age. The patient's weight, height, and medical history were not reported.  The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, intramuscular, batch number: 1805018, expiry: 25-MAY-2021) .5 ml, 1 total, administered on 06-MAR-2021 for prophylactic vaccination. No concomitant medications were reported.  On 07-MAR-2021, the patient experienced fatigue, nausea, and temperature of 100.6F. Laboratory data (dates unspecified) included: Body temperature (NR: not provided) 100.6 Fahrenheit. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the fatigue, nausea and temperature of 100.6F was not reported. This report was non-serious.
recalled shingrix lot was given; recalled shingrixlot was given; This case was reported by a pharmacist via call center representative and described the occurrence of recalled drug administered in a patient who received Herpes zoster (Shingrix) (batch number 9lh3y, expiry date unknown) for prophylaxis.   On an unknown date, the patient received Shingrix. On an unknown date, unknown after receiving Shingrix, the patient experienced recalled drug administered and drug dispensing error. On an unknown date, the outcome of the recalled drug administered and drug dispensing error were unknown.  Additional details provided were as follows: Age at vaccination was not reported. Registered pharmacist reported that recalled Shingrix lot 9lh3y was administered to  patient, which led to recalled drug administered and drug dispensing error. The lot was recalled on 10th February 2021. Health care professional did not have any other details of date of administration. No other information of patient or vaccine available. Reporter did not consented to follow-up. This case was 1 of the 3 cases reported by the same reporter.; Sender's Comments:  US-GLAXOSMITHKLINE-US2021AMR226053:same reporter US-GLAXOSMITHKLINE-US2021225649:same reporter
Swollen arm, fever in arm, soreness on arm, soreness all over the body, fatigue
Patient required hospitalization due to breakthrough infection. He received Pfizer vaccine (2nd dose in series) on 04/08/21. Hospitalized from 08/02/21 - 08/06/21. Below is copied from the discharge summary:   Hospital course: 67 y.o. male with a PMHx of COPD on 2-3L home O2 multiple hosptialization , s/p COVID Pfizer vaccine 2 doses , cocaine user comes with SOB. S/p ICU admission for FF bipap   # Acute on chronic resp failure 2/2 COVID exacerbation  - Solumedrol. Bipap PRN  - weaned to nasal canula  - COVID positive, but fully vaccinated. cxr ok .  S/p dose of tociluzimab  - did work with PT OT well and stable for d/c planning.
Patient began to feel dizzy; sweaty palms and fatigue. Felt numbness & tingling on b/l hands/fingers. BS 94; Pt states she skipped bfast, BP initially 85/49;  gave apple juice & fluid and BP improved to 110/62. Pt AxO x 3
Arm was very sore; This case was reported by a consumer via call center representative and described the occurrence of pain in arm in a 68-year-old female patient who received Flu unspecified (Flu vaccine) for prophylaxis.   On an unknown date, the patient received Flu vaccine at an unknown dose. On an unknown date, unknown after receiving Flu vaccine, the patient experienced pain in arm. On an unknown date, the outcome of the pain in arm was unknown.   It was unknown if the reporter considered the pain in arm to be related to Flu vaccine.  Additional details were received as follows: The age at vaccination was not reported. The patient after receiving flu vaccine noted her arm was very sore. The patient did not recall the name of the flu vaccine at the time of reporting. The patient stated that was due more to technique of giving the vaccine vs the vaccine itself.
This spontaneous report was received from another health professional refers to an unspecified number of patients of unknown age and gender. Between 03-SEP-2014 and 30-SEP-2014 the patients were vaccinated with an improperly stored dose (Oka/Merck) PROQUAD lot # K005117, expiration date: 29-OCT-2015, lot #K007797, expiration date: 29-NOV-2015 (dose, lot# and route of administration were not reported). No adverse effects were reported. This is one of several reports received from the same reporter. Additional information has been requested.
got a mild case of Covid 12 days ago; This spontaneous case was reported by a pharmacist and describes the occurrence of COVID-19 (got a mild case of Covid 12 days ago) in a 78-year-old male patient 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 second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. In December 2021, the patient experienced COVID-19 (got a mild case of Covid 12 days ago). At the time of the report, COVID-19 (got a mild case of Covid 12 days ago) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): In December 2021, SARS-CoV-2 antibody test: positive (Positive) mild case of COVID 12 days ago..     For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   Concomitant medication was not reported. Treatment information was not reported.  Patient had a mild case of COVID 12 days ago and had no symptoms in the last 5 days.  Company comment This is a spontaneous case concerning a 78-year-old male patient with no medical history reported, who experienced the non-serious AESI event of COVID-19. The event occurred in December 2021, after the second dose of mRNA-1273 (vaccination dates are unknown). The rechallenge was assessed as not applicable. The benefit-risk relationship of mRNA-1273 is not affected by this report. Although referred that COVID-19 is diagnosed being fully vaccinated, the information regarding the vaccination dates is incomplete so lack of efficacy situation cannot be properly assessed.   Reporter did not allow further contact; Sender's Comments: This is a spontaneous case concerning a 78-year-old male patient with no medical history reported, who experienced the non-serious AESI event of COVID-19. The event occurred in December 2021, after the second dose of mRNA-1273 (vaccination dates are unknown). The rechallenge was assessed as not applicable. The benefit-risk relationship of mRNA-1273 is not affected by this report. Although referred that COVID-19 is diagnosed being fully vaccinated, the information regarding the vaccination dates is incomplete so lack of efficacy situation cannot be properly assessed.
Patient has had no adverse outcome to date.  Diluent used in administering the vaccine was not the diluent shipped with the vaccine.  The diluent was correct type, concentration (normal saline USP .09% ) , but was in a single use bottle, not intended for use with injection and used with one other patient previously.
A non-serious spontaneous report of thirsty and rash has been received from a health professional concerning a five-year-old female, subsequent to FLUMIST. The patient did not have a hypersensitivity history to eggs or egg proteins. Concomitant medications were not reported. On 12-Nov-2010, the patient received 0.2ml FLUMIST nasally for flu vaccination. The patient had rash on forehead, neck, cheek and chest and was thirsty with no fever. The outcome of all the events was unknown. The reporter assessed the event of rash as possibly related to FLUMIST as it started a few hours of vaccination.
Confusion, Myalgia, fatigue Narrative:  confusion, fatigue, arm pain for 1 week.
Face went red for approximately 1 hour; This is a spontaneous report from a contactable Consumer (patient). A 48-year-old male patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE), dose 1 via an unspecified route of administration, administered in Arm Right on 02Mar2021 09:45 (Batch/Lot Number: EL3247) (at the age of 48 years) as dose 1, single for covid-19 immunisation. Medical history included hypertension from an unknown date and unknown if ongoing. Concomitant medication included olmesartan medoxomil (BENICAR) taken for an unspecified indication, start and stop date were not reported. The patient experienced face went red for approximately 1 hour on 02Mar2021 15:30 with outcome of recovered on 02Mar2021 16:30, with no treatment.  No follow-up attempts are possible. No further information is expected.
On 4/26/00, the pt started running a fever of 101-103. On 4/27/00, she continued with a fever and was treated with Tylenol every 4 hours. Mom noticed rash under armpits and the child seemed very uneasy and uncomfortable. On 4/28/00, she was seen by a physician who said she had a red throat. They did not know what the rash was from. Treated her with Cefzil. On 4/30, the mother noticed that the pt had a rash everywhere on her body. On 5/1/00, the pt was seen by physician again and he dx her with rubella.
About 2 weeks after getting the shot I experienced a spontaneous hematoma on my medial distal lower left leg. I experienced pain and burning on my left side. I also had really bad joint pain on my left hip. It has been 2 weeks waiting for the hematoma to go away. I have never had a hematoma, I was not in any kind of accident, I was not hit by anything, I did not bump into anything to cause the hematoma. I am also not on clotting medication. My doctor has no idea what would cause a muscle hematoma absent medication or trauma.
TWITCHING IN CALVES THAT DESCRIBED AS THE PULSATIONS IN THE BACK OF THE CALVESTWITCHING IN CALVES THAT DESCRIBED AS THE PULSATIONS IN THE BACK OF THE CALVES; HEADACHE; INJECTION SITE PAIN; This spontaneous report received from a patient concerned a 61 year old female. The patient's height, and weight were not reported. The patient's concurrent conditions included: narcotic pain medications allergy. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 201A21A, expiry: UNKNOWN) dose was not reported, administered on 16-AUG-2021 for prophylactic vaccination. Concomitant medications included ananas comosus/animal bone marrow/binetrakin/centella asiatica/interferon gamma/interleukin-1/interleukin-2/interleukin-6/thymus gland/vaccinium vitis-idaea, ascorbic acid, bifidobacterium lactis, ergocalciferol, sambucus nigra, and zinc. On AUG-2021, the patient experienced injection site pain. On 17-AUG-2021, the patient experienced headache. Treatment medications included: paracetamol. On 18-AUG-2021, the patient experienced twitching in calves that described as the pulsations in the back of the calvestwitching in calves that described as the pulsations in the back of the calves. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from headache on 17-AUG-2021, and injection site pain on AUG-2021, and had not recovered from twitching in calves that described as the pulsations in the back of the calvestwitching in calves that described as the pulsations in the back of the calves. This report was non-serious.
Vaccine 10/25 am, woke 10/26 diffuse joint pain, swelling fingers/feet. Used Advil. 10/17-persistent pain shoulders/elbows/knees,spine, wrists painful, decreased flexion. Symptoms gradually resolved over 48 hours.
This spontaneous report as received from a registered nurse refers to a patient of unknown age and gender. On 08-APR-2013 the patient was inadvertently administered GARDASIL that had been improperly stored, 0.5 ml (lot# not reported), intramuscularly. No adverse effects reported. It was not reported if the patient seek medical attention. Additional information has been requested.
got two shots, then got internal shingles/suspected vaccination failure; internal shingles; pain in neck; numbness in ear; This case was reported by a consumer via interactive digital media and described the occurrence of suspected 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, 6 months after receiving Shingles vaccine and less than 2 years after receiving Shingles vaccine, the patient experienced vaccination failure (serious criteria medically significant), shingles, neck pain and numbness. The patient was treated with valaciclovir hydrochloride (Valtrex). On an unknown date, the outcome of the vaccination failure and shingles were unknown and the outcome of the neck pain was not recovered/not resolved and the outcome of the numbness was recovered/resolved.   It was unknown if the reporter considered the vaccination failure, shingles, neck pain and numbness to be related to Shingles vaccine and Shingles vaccine.  Additional details were provided as follows:  The patient self-reported this case.                                        The age at vaccination was not reported. The patient got the two Shingle shots in 2020 and then got internal shingles 6 months later.  The patient reported that her/his physician too believed of getting shingles in 2021. The patient's ear went numb for two months before he/she realized that he/she had shingles.  Therefore, patient was late getting the antivirals and took Valtrex as prescribed. The patient hoped that his/her pain in neck goes away soon. The patient had no rash, but severe neck pain that kept coming back.. The patient still had month later neck pain. This case was considered as suspected vaccination failure since the details regarding completion of laboratory test confirming shingles was unknown at the time of reporting. The follow-up would not possible as no contact details were available
On Wed, Feb 9th, three day after the 3rd dose, the patient felt a lump under the left arm (the same arm of vaccination).; This is a spontaneous report from a contactable reporter (consumer or other non HCP).   A 63 year-old female patient (not pregnant) received bnt162b2 (BNT162B2), administered in arm left, administration date 06Feb2022 (Lot number: FK9729) at the age of 63 years as dose 3 (booster), single for COVID-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: Bnt162b2 (DOSE 1, SINGLE; Lot Number: EW0169), administration date: 15Apr2021, when the patient was 62 years old, for COVID-19 immunisation and Bnt162b2 (DOSE 2, SINGLE; Lot Number: EW0183), administration date: 09May2021, when the patient was 62 years old, for COVID-19 immunisation.  The following information was reported: AXILLARY MASS (non-serious) with onset 09Feb2022, outcome "not recovered", described as "On Wed, Feb 9th, three day after the 3rd dose, the patient felt a lump under the left arm (the same arm of vaccination)". Therapeutic measures were not taken as a result of axillary mass.  Additional information: It was reported that the lump under the left arm of the patient was about the size of an egg, the next day. The patient still had the lump when this was discussed on 12Feb2022 (as 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 COVID-19 vaccine. Since the vaccination, the patient had not been tested for COVID-19. The event did not result in doctor or other healthcare professional office/clinic visit and emergency room/department or urgent care.  No follow-up attempts are possible. No further information is expected.
Came into office 10-3-2008 at 4 pm with red induration on right arm. Measures Measures 48 mm long X 52 mm wide. Itches warm to touch, Tender, site where Varicella was given on 10-1-2008. Instructed to apply ice and to take Tylenol for pain and benedryl for itching and see MD in morning if not better.10 - 6 - 2008 TC to mother to flu. She reports area was much better 10- 4 - 2008 am and did not see MD-RM
Over the next 24 hours from 06/16/21 - 06/17/21, starting at 1:45 am - high fever of 102; severe body aches; headache; chills; lethargy; weakness; loss of appetite; nausea; diarrhea.