chrisvoncsefalvay/vaers-outcomes huggingface dataset:
has been running a fever; arm was sore; This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (arm was sore) and PYREXIA (has been running a fever) in a 67-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On 25-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 25-Jan-2021, the patient experienced PAIN IN EXTREMITY (arm was sore). On an unknown date, the patient experienced PYREXIA (has been running a fever). The patient was treated with PARACETAMOL (TYLENOL) at an unspecified dose and frequency. At the time of the report, PAIN IN EXTREMITY (arm was sore) and PYREXIA (has been running a fever) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No concomitant medication was provided.
Pt. felt OK the day of vaccine. The following night she began to feel tired and said she had chills.  The next morning she woke up and had shaking chills which were persistent. She called EMS and was brought to the local ED where she continued to feel shaky and weak. She was admitted to hospital to rule out dehydration , suspected UTI, and Reaction to Covid Vaccine. Her vital signs remained stable. She was treated with 3 days of Rocephin. She had initial weakness and shakiness which gradually improved with Physical Therapy.  Pt. was discharged on 4/7.
Nurse 1 was pulling out needle from vial after dilution for pediatric Pfizer COVID 19 Vaccine (5-11 y/o) and Nurse 2 noticed the syringe that Nurse 1 used to dilute was a 5 cc syringe not a 3 cc syringe. Therefore, the vaccine was diluted with 1.6 mL NS not 1.3 mL. One vial had previously been diluted with the same syringe in the morning session and 10 vaccines were given. Parents of the children who received the vaccine in AM session will be called and notified. Provider, Supervisor and Nurse Manager were notified. Pfizer and CDC COVID Call Centers were called/consulted; both gave the CDC resources/instructions (COVID-19 Vaccine-Administration Errors and Deviations) that states, for this diluent error/deviations ?do not repeat the 1st dose? and they recommended that children receive their second dose as scheduled. Second vial was wasted with 10 doses.
Recently my grandfather presented at clinic for a flu shot, and received a COVID vaccine in error. He had received his first (Pfizer) vaccine dose 9 days prior. This incident is being reported because we are concerned about (i) mixed series (1st dose Pfizer on 2/9; 2nd dose Moderna on 2/18), (ii) Interval error (10 days between 2 series), and (iii) immunity concerns (Moderna 28; Pfizer 21 days). He reports feeling fine, and we are closely monitoring him during this time.
Pfizer-BioNtech Dose 3 10/29/2021 and FF2587. On 01/10/2022, I noticed that I was feeling heaviness on my chest as if I was being restricted or held down. I am having heart issue is an unknow caused for two weeks solid and now it is every once in a while, but not as intense as when it presented in Jan. 2022. My primary has me scheduled to see a Cardiologist for them CTA workup May 19, 2022. Had a tele visit with doctor 12/01/2022. Drive through sites for COVID-19 positive. I did have COVID-19 in Dec. 2, 2020, COVID-19 positive and was able to receive the BAM Infusion 12/09/2022. Still under doctor care and have upcoming appoints.
Rebound infection after testing negative with a home test for 7days; Rebound infection after testing negative with a home test for 7days; This is a spontaneous report received from a non-contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 39-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 18Nov2021 at 12:00 as dose 3 (booster), single (Batch/Lot number: unknown) at the age of 39 years, in left arm for covid-19 immunisation; coviD-19 vaccine (COVID-19 VACCINE), as dose 1, single (Batch/Lot number: unknown) and as dose 2, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history included: "Pectus excarvatum" (unspecified if ongoing); "Known allergies: mosquito bites" (unspecified if ongoing). The patient took concomitant medications. Past drug history included: Sudafed, reaction(s): "known allergies". The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant), outcome "recovering" and all described as "Rebound infection after testing negative with a home test for 7days". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (Jul2022) Negative. Therapeutic measures were taken as a result of drug ineffective, covid-19.  Clinical course: Patient received Anti viral treatment for Covid 19. Patient received other concomitant medications within 2weeks which includes multivitamin from 30un2022 to 01Aug2022.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Day after immunization patient states hives arms, legs, back. Returned to clinic 12/8/10. Referred to MD or ER.
Ocular exposure to pustule fluid. PT seen by an othalmologist. Fluid from pustule splashed into eye during bandage change. Copious irrigation with H2O x 10 mins. Initial tearing. Follow up information received on 2/28/03 states: On 2/28/03 - no symptoms.
0940 RN reviewed pre-vaccination checklist. Reviewed precautions with patient. 0945 RN gave vaccine. Immediately asked how he was doing, he said he was "fine". Moved patient to waiting area and wife waiting with him.  0953 Wife notified called nurse for help, nurse noted he was "zoned out" with eyes open, unresponsive, and cold. Vital signs taken, blood pressure 86/54, pulse 99, Oxygen saturation machine unable to read. Rapid Response Team was called.  He was given sternal rub, and patient responded.   Glucose checked via finger prick, 139.  Alert patient was given juice.  He vomited immediately after.  0957 Rapid Response Team arrived. Taken  to  emergency room.
This spontaneous report as received from a healthcare worker refers to a patient of unknown age and gender. Pertinent medical history was unknown. The reporter stated that on 07-OCT-2014 the patient was vaccinated with an expired dose of M-M-R II (lot # H018181, expiry date: 05-OCT-2014, 0.5 ml, subcutaneous, anatomical location was unknown. Concomitant medications were unspecified by reporter. No adverse effect was reported. The outcome of the events was unknown. No further information was provided. Additional information has been requested.
102.2 degF fever Nausea Chills Joint pain in shoulders,  hips
5/9/13 Redness and a little puffy, no fever. Red down to elbow (L) arm. 5/10/13 Redness extends down to (L) forearm now, warm to touch, no fever, no streaking, no pain, no discharge, still puffy, skin feels tight. Has full ROM. Tx: Ice to site, MOTRIN q 6-8 hours. Monitor temp.
Heart since beating really very fast; I can't even walk; Feel really drunk; Also numbness I guess my face; 'Swollen' face; Don't feel good; Dizzy; I am weak, if you look into my eyes I look I am really sick; I am tired; Headache; Sick; can not even speak; This is a spontaneous report received from a contactable consumer (Patient) or other non HCP.   A 51-year-old female patient received first dose of BNT162B2(PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Batch/Lot Number: EW0181, Expiration date: unknown) via an unspecified route of administration, administered in Arm Left on 12Jun2021 11:00 (at the age of 51-years-old) as first dose single dose for covid-19 immunisation.The patient medical history and concomitant medications were not reported. On 12Jun2021, the patient experienced heart since beating really very fast, cannot even speak, feel really drunk, also numbness in face, swollen face, don't feel good, dizzy, weak, tired, headache, sick and can't even walk. Patient had some side effects from the shot today. Got the first dose this morning, since then her heart beating really very fast throughout the day, she actually felt really drunk, she cannot even speak to you, cannot even walk, she was out of it. Consumer stated, that was not worrying, she did not feel good, she did not really feel very good (voice not clear). She was tired, had a headache, her face was like either swollen or numb, she was dizzy, she was weak, she told that if someone look into her eyes, she looked like she was really sick, she can hardly even walk, felt like she drunk. The patient underwent lab tests and procedures which included heart rate: fast on 12Jun2021.The outcome of events was not recovered.   Information on Lot/Batch number was available. Additional information has been requested.
Numbness to feet-progressed to level of chest-difficulty breathing currently in hosp; sx began 27APR92;
HR and BP suddenly elevated 10 minutes after vaccine and I almost passed out. I was monitored for 30 minutes and released after HR and BP came down with no treatment. I felt dizzy and almost passed out 3 more times that day at home.
Overall weakness, started drooling, decreased leg hypertonia, decreased abdominal muscle function, extreme constipation with inability to pass stool without daily Fleet enema. Still able to walk, but slower.
Pain in my testes ? from the spermatic cord on down,  off and on the entire night during sleep; midnight until 830am.
It has been a month, and I can barely raise my right arm.  And that with a lot of pain.
sx felt weak, dizzy, sweating, sign pale;systemic sx lasted about 15min;pt 02, & close observation;
Fever, breast tenderness & redness. Felt throat closing with SOB. Neck redness. Pt advised to take BENADRYL if worse ER.
FEVER; INJECTION SITE SWELLING; This spontaneous report received from a parent 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, route of admin not reported, batch number: Unknown) dose, start therapy date were not reported for prophylactic vaccination. The batch number was not reported and has been requested. No concomitant medications were reported. On APR-2021, Laboratory data included: Body temperature (NR: not provided) 102.4, 102.7. On an unspecified date, the subject experienced fever, and injection site swelling. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the fever and injection site swelling was not reported. This report was non-serious.
I had the second dose on 6/22/2021 and my symptoms got worse after the COVID shot, it exacerbated everything that was wrong with me, my kidneys function went down, they got compromised, I was not peeing much, I had pain on my neck, horrible ear symptoms of ringing and high pitch sound. It lasted for a day. Hip and joint pain, my knee hurt me a lot. I was weak and unable to do a lot of things. My heart rate went down, my potassium went up. I ended up in the hospital and they admitted me for 4 days. They kept taking blood every day and my sugar levels. They gave me heparin.
Information has been received from a 64 year old female consumer with allergy to adhesive tape and to TALWIN and a history of cancer/"vasectomy" in December 2003 and shingles approximately in May 2008 "2 and a half year ago" who in 18-OCT-2010, was vaccinated SQ with a 0.65 ml dose of ZOSTAVAX (Merck) (Lot# not reported). Concomitant therapy included LASIX. The consumer developed shingles shortly after receiving the vaccine. She began to felt headachy on the 18-OCT-2010. She then felt unwell on 19-OCT-2010. The doctor then diagnosed her with shingles on 23-OCT-2010. There was not lab diagnostics studies performed. At the time of the report, the consumer was recovering. Additional information has been requested.
apprx 2 days after receiving vaccinations pt developed moderate hives, erythema, to bilateral forearms, thighs, lower back, scalp, forehead
extreme dryness; eczema like rash; extreme facial swelling for prolonged 6 days; This is a spontaneous report from a contactable consumer (patients mother) reported for a female patient (reporters daughter). A 16-years-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Batch/Lot number: EW0180, Expiration date: unknown), via an unspecified route of administration, administered at an unspecified anatomical location on 24Jun2021 (age at vaccination was 16 years) as dose 1, single for COVID-19 immunization. The patient's medical history and concomitant medications were unknown. On an unspecified date the patient experienced extreme dryness, extreme facial swelling for prolonged 6 days and eczema like rash. Patients reaction was so long it lasted 6 days. Facial swelling broke out eczema like rash. Patient was kept on Benadryl for 24 hours for 6 days. On the 6th day the swelling went off. Swelling was gone and rash is causing extreme dryness. Therapeutic measures were taken as a result of extreme facial swelling for prolonged 6 days and eczema like rash.She has been to two Doctors for extreme facial swelling. The outcome of the events extreme dryness and eczema like rash was unknown and the event extreme facial swelling for prolonged 6 days was recovered on an unspecified date.  Follow up attempts are Possible. Further information is expected.
It was reported that a 3 year old female received her fourth dose of Imovax Rabies vaccine on 4-5-00. Reportedly that same day the pt developed hives. Additional information is being requested. On 4-11-2000, it was reported that the pt has a history of developing hives after receiving antibiotics or dyes.
Woke around 6am and was fussy. Took a bottle, was given Motrin, and then slept some more. Woke around 8am and was noted to have right-sided facial swelling. Seen in the office same morning with marked right parotid swelling. Titers pending.
HIGHLY SENSITIVE SKIN; CHILLS; FEVER AT 101 DEGREES; EXTREME FATIGUE(COULDN'T GET OUT OF BED OR EAT FOR 8 HOURS); HEADACHE; 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 not reported) dose, start therapy date were not reported for prophylactic vaccination. The batch number was not reported. Per procedure, no follow-up will be requested for this case. No concomitant medications were reported. On an unspecified date, the subject experienced highly sensitive skin, chills, fever at 101 degrees, extreme fatigue (couldn't get out of bed or eat for 8 hours), and headache. Laboratory data (dates unspecified) included: Body temperature (NR: not provided) 101 F. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the chills, highly sensitive skin, fever at 101 degrees, extreme fatigue(couldn't get out of bed or eat for 8 hours) and headache was not reported. This report was non-serious.
Almost 2-3 weeks after vaccination I started having chest pain. It got progressively worse after the next few day and then I went to the doctor, they did a chest x-ray. The next day I went to the ER and they diagnosed inflammation and was given steroids'. It started to get better within a few days
Hospitalized with COVID-related pneumonia on 03 Jan 2021.   Close contact exposure on 25 Dec, with positive COVID PCR test on 29 Dec... managed as outpatient until respiratory sxms prompted hospitalization on 03 Jan.  Care team anticipates at least 4 inpatient days... but patient remains hospitalized at date of this report.
Pneumonia; This spontaneous case was reported by a consumer and describes the occurrence of PNEUMONIA (Pneumonia) in a 61-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 013U20A and 027L20A) for COVID-19 vaccination.     No Medical History information was reported.   On 08-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 08-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient experienced PNEUMONIA (Pneumonia) (seriousness criteria hospitalization and medically significant). At the time of the report, PNEUMONIA (Pneumonia) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No relevant concomitant medications were reported.  No treatment information was provided.  Company Comment: This case concerns a 61-year-old, female patient with no previous relevant medical history reported, who experienced the unexpected event of pneumonia. The events occurred on an unknown number of days after the second dose of mRNA-1273. The rechallenge was not applicable since the events happened after the second dose. The benefit-risk relationship of mRNA-1273 is not affected by this report. Further information was requested.; Sender's Comments: This case concerns a 61-year-old, female patient with no previous relevant medical history reported, who experienced the unexpected event of pneumonia. The events occurred on an unknown number of days after the second dose of mRNA-1273. The rechallenge was not applicable since the events happened after the second dose. The benefit-risk relationship of mRNA-1273 is not affected by this report. Further information was requested.
swelling, redness & warmth at injection site, size of a "tangerine" per employee
patients were given shots during excursions.; This spontaneous case was reported by an other health care professional and describes the occurrence of PRODUCT TEMPERATURE EXCURSION ISSUE (patients were given shots during excursions.) in an 81-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On 02-Nov-2021, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) .25 ml. On 02-Nov-2021, the patient experienced PRODUCT TEMPERATURE EXCURSION ISSUE (patients were given shots during excursions.). On 02-Nov-2021, PRODUCT TEMPERATURE EXCURSION ISSUE (patients were given shots during excursions.) had resolved. Not Provided      For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   No Concomitant Medications were Reported. No Treatments were Reported.   This case was linked to MOD-2021-423303, MOD-2021-423390 (Patient Link).
About 36 hours after receiving my shot I started to have a high fever, causing me to wake up drenched from sweat it look like I got out the shower. About 48 hours after the vaccine I started to have congestion and a runny nose. I also had headache, sinus pressure, sore throat and cough, 48 hours after receiving the vaccine. Today, on June 7th I am still having these side effects.
Pt arm 4 cm x 3.5 cm red, raised, hot oval. Lt arm 5 cm x 5.5 cm red,raised hard hot oval (Both were given with an injection gun). Pain when touched, itches (can be felt under skin). Blister at site.
given vaccine which was beyond the 30 day use by date; No adverse event; given vaccine which was beyond the 30 day use by date; given vaccine which underwent temperture excursion; This spontaneous case was reported by an other health care professional and describes the occurrence of PRODUCT TEMPERATURE EXCURSION ISSUE (given vaccine which underwent temperture excursion), PRODUCT STORAGE ERROR (given vaccine which was beyond the 30 day use by date), EXPIRED PRODUCT ADMINISTERED (given vaccine which was beyond the 30 day use by date) and NO ADVERSE EVENT (No adverse event) in an 88-year-old patient of an unknown gender who received mRNA-1273 (Spikevax) (batch no. 083B22A) for COVID-19 vaccination.     No Medical History information was reported.   On 19-Sep-2022, the patient received fourth dose of mRNA-1273 (Spikevax) (Intramuscular) 1 dosage form. In August 2022, the patient experienced PRODUCT TEMPERATURE EXCURSION ISSUE (given vaccine which underwent temperture excursion). On 19-Sep-2022, the patient experienced EXPIRED PRODUCT ADMINISTERED (given vaccine which was beyond the 30 day use by date). On an unknown date, the patient experienced PRODUCT STORAGE ERROR (given vaccine which was beyond the 30 day use by date) and NO ADVERSE EVENT (No adverse event). At the time of the report, PRODUCT TEMPERATURE EXCURSION ISSUE (given vaccine which underwent temperture excursion), PRODUCT STORAGE ERROR (given vaccine which was beyond the 30 day use by date), EXPIRED PRODUCT ADMINISTERED (given vaccine which was beyond the 30 day use by date) and NO ADVERSE EVENT (No adverse event) outcome was unknown.      For mRNA-1273 (Spikevax) (Intramuscular), the reporter considered NO ADVERSE EVENT (No adverse event) to be not related. No further causality assessments were provided for PRODUCT TEMPERATURE EXCURSION ISSUE (given vaccine which underwent temperture excursion), PRODUCT STORAGE ERROR (given vaccine which was beyond the 30 day use by date) and EXPIRED PRODUCT ADMINISTERED (given vaccine which was beyond the 30 day use by date).    No relevant concomitant medications were reported. Patient had gotten vaccine which underwent temperature excursion on 15-17Aug 2022. No treatment medication reported.   This case was linked to US-MODERNATX, INC.-MOD-2022-681465, US-MODERNATX, INC.-MOD-2022-682086 (E2B Linked Report).; Sender's Comments:  US-MODERNATX, INC.-MOD-2022-681465:MOD22-030301, MOD22-030312 US-MODERNATX, INC.-MOD-2022-682086:
patient kicked during vaccination. received scratch to thigh as result. mom reported next day patient with swelling and redness to site which has since resolved. mother had telehealth appointment with doctor day after vaccination and advised to take tylenol / motrin PRN and ice site as needed.
A report was received from a health care professional on 25 November 2003, concerning a 2 year old male vaccine who inadvertently received Fluvirin on 14 November 2003.  On 14 November 2003 the vaccine inadvertently received 0.25ml of Fluvirin.  At the time of the report no adverse events had been reported.  There was insufficient information to determine the reporter's causality assessment.  Update 1, 11 March 2004:  Further information received from a health care professional indicated that the vaccine did not experience any adverse reaction at the time of the report.  No follow-up pending, all information received.