chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Got swings after got the shot/suspected vaccination failure; Got swings; This serious case was reported by a consumer via interactive digital media and described the occurrence of vaccination failure in a male 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 vaccination failure (Verbatim: Got swings after got the shot/suspected vaccination failure) (serious criteria GSK medically significant) and shingles (Verbatim: Got swings). The outcome of the vaccination failure was unknown and the outcome of the shingles was not reported.   It was unknown if the reporter considered the vaccination failure and shingles to be related to Shingles vaccine.     It was unknown if the company considered the vaccination failure and shingles to be related to Shingles vaccine.   Additional Information: GSK receipt date: 10-Mar-2023 The case was received from the patient's wife via interactive digital media. The patient's wife and the patient got swings after they got the shot. The patient stated figure that out. This case was considered as suspected vaccination failure since the details regarding the completion of primary vaccination schedule, time to onset and laboratory confirmation of shingles were unknown at the time of reporting. The follow-up could not be possible as no contact details were available. The case was linked with case US2023AMR041182, reported by same reporter for her husband.; Sender's Comments:  US-GSK-US2023AMR041182:Same reporter
Received 1st vaccine at 3weeks, 2nd vaccine at 6 weeks, at 7 weeks saw baby and heart beat at 9 w5 d, started to spot and imaging showed no heart activity and baby stopped growing at 8w4d. D&C completed on 2/21 at 9w6d. No side effects from first vaccine, 2nd vaccine, body aches, fever (101) controlled with Tylenol, chills, joint pain, headache. Resolved after 3 days.
Arm sore; wrist pain; hand cramps; runny nose; rash on stomach; This is a spontaneous report from a contactable other HCP (patient). A 37-year-old non-pregnant female patient received second dose of BNT162B2 (Pfizer COVID-19 vaccine, Solution for Injection, Lot number EL3249), via an intramuscular route in the arm right on 26Jan2021 (at the age of 37-year-old) as 2nd dose, single dose for covid-19 immunization in Public Health Clinic. Medical history included allergy to sulfa drugs, supraventricular tachycardia and high blood pressure. Concomitant medications in two weeks included metoprolol succinate, losartan, atomoxetine hydrochloride (STRATTERA), amfetamine aspartate, amfetamine sulfate, dexamfetamine saccharate, dexamfetamine sulphate (ADDERALL) and fexofenadine hydrochloride (ALLEGRA). Historical vaccine included first dose of BNT162B2 (Pfizer COVID-19 vaccine, Solution for Injection, Lot number- EK4176), via an intramuscular route in the arm left on 06Jan2021 (at the age of 37-year-old) as a single dose for covid-19 immunization. Patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Prior to vaccination, patient was not diagnosed with COVID-19. Since the vaccination, patient has not been tested for COVID-19. On 27Jan2021, patient experienced arm sore, wrist pain, hand cramps, runny nose and rash on stomach. Patient did not receive any treatment for the events. On 10Jan2021 patient underwent nasal swab test with result as negative (POC COVID-19). The clinical outcome of the events was recovered at the time of this report.  Follow-up attempts are completed. No further information is expected.
1/21/2018 child presented with a fever of 102.5 around 11:00pm. 5ml of TYLENOL given. 1/22/2018 child's fever remained but had no other symptoms. Was taken to pediatric clinic for catheterization and urine sample since there is a history of VUR. 5pm lab called and confirmed urinalysis was clean. 72 hour wait for cultures. 1/22/2018: child bathed and had temperature taken rectally around 7pm. Rectal temperature read 103.5. Child then starting having arm convulsions, staring at the ceiling, would not respond to his name being called and had shallow breathing. Episode lasted less than 30 seconds. Child was given 5ml of TYLENOL which he vomited within minutes. Child seemed dazed, and confused for roughly 30 minutes after episode. Child was taken to the emergency room and presented a 102.9 fever. Was given TYLENOL rectally.
pt recvd vax 16OCT95 & devel inj site rxn characterized by redness, warmth, swelling & hardness;the above rxn lasted for 1 day and subsided;this is one of the three patients from this site who exp this rxn
11/18/09 States 1 hr after H1N1 injection, experienced tingling to L arm, L hand, both feet. States she notified Dr office. 11-18-09 left message to call PCHD. 11/24/09 Medical records received for date 11/18/09. Telephone to MD Pt. c/o arm/hand/feet tingling started 1 hr after H1N1 vax. 12/7/09 Medical records received for date 11/24/09. Neuro consult. DX: numbness, demyelinating disease. Eval for numbness/tingling both arms, then later both legs after H1N1 vax x1 wk ago. Pt. now presenting with bilat calf pain radiating to hamstrings. Assessment: WNL
No issues after the vaccine, but long term after, I had Asthma. I was in the hospital twice, for a blood infection, in April and June 2022. The first was for kidney infection, the 2nd time they did not know. Mid-October I started with Asthma, and I used an inhalator.
The day after the vaccine was administered, she had increased heart rate and dizziness prompting her to get evaluated at Regional ER.  On 4/21/21, she was seen in primary care- she complains of ongoing increased palpitations.  EKG performed and was normal.
COVID 19; COVID 19; This is a spontaneous report received from contactable reporter(s) (Nurse). The reporter is the patient.  A 76-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 14Jan2021 at 10:00 as dose 1, single (Lot number: EL0142) at the age of 74 years, in right arm for covid-19 immunisation. The patient's relevant medical history included: "HTN" (unspecified if ongoing); "Known allergies: Penicillin" (unspecified if ongoing); "Known allergies: Sulfa" (unspecified if ongoing). Concomitant medication(s) included: TYLENOL EXTRA STRENGTH, start date: 03May2022. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant), outcome "not recovered" and all described as "COVID 19". Therapeutic measures were taken as a result of drug ineffective, covid-19.
Rectal Bleeding after vaccination during pregnancy.  No complications with labor and delivery of my son in September 2021. October, 2 weeks after his birth I was hospitalized with severe ulcerative colitis. A condition I had zero prior symptoms of.
Swelling of Face.  Shortness of breath. Increase Heart Rate.  Chest tightness. Neck and Body Ache.
Patient received the vaccine today at 1pm and suffered a seizure lasting more than 5 minutes around 5pm.   Patient has a history of seizures but the wife said that this one last longer than his usual course.
Stroke; This spontaneous case was reported by a consumer and describes the occurrence of CEREBROVASCULAR ACCIDENT (Stroke) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.   On 24-Feb-2021, the patient 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 received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 17-May-2021, the patient experienced CEREBROVASCULAR ACCIDENT (Stroke) (seriousness criterion medically significant). At the time of the report, CEREBROVASCULAR ACCIDENT (Stroke) outcome was unknown.            No Treatment informations were reported.  This case concerns a female patient (age not provided) with no relevant medical history, who experienced the unexpected event of Cerebrovascular Accident. The event occurred approximately 2 month 24 days after the second dose of mRNA-1273 (Moderna Covid-19 vaccine). The rechallenge was unknown since no information about the first dose was disclosed. The benefit-risk relationship of mRNA-1273 (Moderna Covid-19 vaccine) is not affected by this report.; Sender's Comments: This case concerns a female patient (age not provided) with no relevant medical history, who experienced the unexpected event of Cerebrovascular Accident. The event occurred approximately 2 month 24 days after the second dose of mRNA-1273 (Moderna Covid-19 vaccine). The rechallenge was unknown since no information about the first dose was disclosed. The benefit-risk relationship of mRNA-1273 (Moderna Covid-19 vaccine) is not affected by this report.
Dizziness, Diarrhea, pain injection site, fatigue, Narrative:  Other Relevant History:
That day in the afternoon my daughter was feverish, I gave her 2.5ml of TYLENOL so she could sleep better. Several days later, red spots appeared on her two thighs, similar to mosquito bites. Two red spots on one thigh and one on the other.
Flu like symptoms; This spontaneous case was reported by a consumer and describes the occurrence of INFLUENZA LIKE ILLNESS (Flu like symptoms) in a 76-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 prophylaxis.     No Medical History information was reported.   On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, 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 INFLUENZA LIKE ILLNESS (Flu like symptoms). At the time of the report, INFLUENZA LIKE ILLNESS (Flu like symptoms) outcome was unknown.            No concomitant medications were reported. It was reported that patient had flu like symptoms with 2nd dose of vaccine, but he did not experienced anything permanent like tinnitus. No treatment medications were reported. This case was identified as part of a retrospective clean-up activity where certain emails received in the Moderna mailbox were missed to be booked-in.
The patient presented to my office with multiple complaints, ranging from constitutional myalgia,  reduced reflex, slowed reaction time, and an episode of spontaneous bleeding. She reports that she was fully COVID recovered as of March 2021, then received second dose of Moderna COVID-19 vaccine as of April 2021.  Patient reported that above listed symptoms began in September 2021, with rapid progression. Recent progression includes chest and thoracic pain and evidence of Autoimmune Disease with labs and other diagnostics. She is currently under my care for ongoing evaluation, and I continue to await further diagnostic results, as well as clinical impression from other specialties I am currently in collaboration with. Definitive diagnosis has not ben made at this time, as testing is ongoing. Patient was otherwise healthy prior to this, apart from some mild hyperlipidemia.
Bad chills and shaking followed by extreme headache.  Lasted 24 hours and then gone..
p/vax pt exp bullseye rash, joint swelling, arthritic pain, herpes zoster outbreak;tx w/percocet for post herpetic neuralgia;lymerix was discontinued;pt recovered;
Acute myocarditis on 6/12/2021 --- chest pain, dysphagia, transient chills
MRN:  Name:  Age: 93 y.o. Birthday:   Admit Date: 7/20/2022 11:44 AM Discharge Date:  7/24/2022 Unit:  Admitting Physician:  Discharge Physician:  MD   Discharge Diagnosis: Principal Problem:   COVID-19 Active Problems:   Hypothyroid   Hypoxia       HPI AND HOSPITAL COURSE   History of Present Illness:  As per admission H&P, "patient is a 93 y.o. female resident of SNF. Onset of low O2 sat there, they have had COVID outbreak thus tested regularly for COVID and O2 sats monitor. Apparently caused by COVID infection, it was +. coughign some with this, not that short of breath. Better with O2 supplementation, nothing makes it worse. No fever, no vomiting. "   Hospital Course: Patient is a 93 y.o. female who presented with hypoxia, COVID positive.  She was managed for the following:   * COVID-19 Acute Hypoxic Respiratory Failure - due to COVID-19 Pneumonia.  patient was admitted from her SNF after found to have hypoxia and COVID positive.  She was started on remdesivir and steroids, treated for 5 day course. She improved, was weaned to 2L NC.  She felt improved, was discharged back to her SNF.  Will taper steroids since still requiring oxygen.    HTN - continue home meds.     Hypothyroidism - continue synthroid.             Physical Exam on the Date of Discharge: Blood pressure 139/60, pulse 69, temperature 98 °F (36.7 °C), temperature source Oral, resp. rate 16, height 5' 4" (162.6 cm), weight 49.9 kg (110 lb), SpO2 96 %. General - NAD, appears stated age, frail elderly female HEENT - EOMI, PER, MMM, oropharynx clear Chest - lungs clear bilaterally, no w/r/r, normal effort Heart - RRR, NS1S2, no m/r/g Abdomen - Soft, non-tender, non-distended, +BS,  Extremities - warm, no edema Psych - AAOx3, affect appropriate Skin - no rash, dry   Discharge Condition: improved   Disposition: SNF
Information has been received from a health professional concerning his/her nephew, an 18 year old male who on 05-AUG-2010 was vaccinated the first  0.5ml dose of with GARDASIL (Lot number not provided). On 05-AUG-2010 the patient experienced dizziness and fainting immediately after being administered GARDASIL. It was reported that the patient was planning to get his second and third doses of the regimen (also reported that the therapy was discontinued on 05-AUG-2010). The patient sought unspecified medical attention. The adverse events improved after therapy. At the time of the reporting, the patient was recovering. The patient's twin brother also experienced dizziness and fainting after being administered his first dose of GARDASIL (WAES#1010USA02874). Additional information has been requested.
I had the typical 2nd shot symptoms; Based on the current case data, this case has been classified as invalid. This spontaneous case was reported by a patient and describes the occurrence of VACCINATION COMPLICATION (I had the typical 2nd shot symptoms) in a patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     The patient's past medical history included No adverse event.   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 at an unspecified dose. On an unknown date, the patient experienced VACCINATION COMPLICATION (I had the typical 2nd shot symptoms). At the time of the report, VACCINATION COMPLICATION (I had the typical 2nd shot symptoms) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No concomitant information was provided. Treatment information was not provided.   Reporter did not allow further contact
Sore arm; This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (Sore arm) in a female patient of an unknown age 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) 1 dosage form. On an unknown date, the patient experienced PAIN IN EXTREMITY (Sore arm). At the time of the report, PAIN IN EXTREMITY (Sore arm) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No concomitant product use was provided by the reporter. No treatment medication was provided. Patient reported that her daughter had a sore arm after both of her doses .   This case was linked to MOD-2021-358289 (Patient Link).
My side effect came about 2 pm ish.I started having a very bad headache and felt that my nose was swollen. (back story- I broke my nose back in college and was fixed) I took an asprin and took a nap and at about 4 pm I noticed and felt that the bridge oof my nose was swollen and it hurt to the touch almost like it was broken aga it twas alos red and hot.  I didnt do anything but take another asprin and went to bed hatt evening..the pain persisited till the next day but by the evening the swelling had gone down and only hurt a little.
injection site was red and sore (minor), major problems extremely painful jaw on right side along with severe chest pain center chest. To a lesser degree arms and hands were aching from elbows to finger tips. I am able to monitor blood pressure and do at home EKG to monitor a fib and they reminded normal but pain was debilitating and would wake me from sleep. Episodes were sporadic and could last from 5 minutes to half an hour. Nothing seemed to relive pain. Doctor performed EKG, x ray, blood tests listened to heart and has ordered stress test. No cause has been determinded
Severe rash and discharge from breasts- took Benadryl and am monitoring now. The rash has gone but the skin is scabbed  over and is painful.  Developed chest pain on day 3 going to hospital now
The following day after receiving the first shot, my arm was sore and it lasted a day of two and had tiredness. I had metallic strange taste in my mouth that went away and came back a few times but nothing more than that and not a big deal. I was perfectly fine after those 3 days. Up until the 25th and woke up that morning with arm being sore like and very difficult to move and thought it was very strange and lasted all day and I took Tylenol and into the next morning the 26th it was very sore. That morning I noticed a rash around my arm around the injection where I had the shot and was itchy and still sore. That was the extent of it, the redness continued to migrate down my arm so the next morning I was feeling off so I went to the Doctor that day to be seen. He gave me antibiotic and told me not to get the second shot until we figured it out. The next Tuesday my arm looked and felt better already. Dr. mentioned Cellulitis. I took the antibiotic and it made me very sick and didn't take it anymore. Awaiting followup.
intermittent rectal bleeding; dizziness; rash; Headache, head pain is so debilitating; fever/fever is mainly at nighttime; fatigue; This spontaneous case was reported by a consumer (subsequently medically confirmed) and describes the occurrence of RECTAL HAEMORRHAGE (intermittent rectal bleeding) in a 28-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 004M20A and 027L20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No medical history was reported by the reporter.  Concomitant products included CETIRIZINE HYDROCHLORIDE (ZYRTEC [CETIRIZINE HYDROCHLORIDE]) for an unknown indication.   On 08-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 05-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 05-Feb-2021, the patient experienced DIZZINESS (dizziness), RASH (rash), HEADACHE (Headache, head pain is so debilitating), PYREXIA (fever/fever is mainly at nighttime) and FATIGUE (fatigue). On an unknown date, the patient experienced RECTAL HAEMORRHAGE (intermittent rectal bleeding) (seriousness criterion medically significant). At the time of the report, RECTAL HAEMORRHAGE (intermittent rectal bleeding) outcome was unknown and DIZZINESS (dizziness), RASH (rash), HEADACHE (Headache, head pain is so debilitating), PYREXIA (fever/fever is mainly at nighttime) and FATIGUE (fatigue) had not resolved.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, Laboratory test: normal. On an unknown date, SARS-CoV-2 test: (Negative) Swab was taken every week after patient got her second dose..     For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   Treatment medications included acetaminophen, ibuprofen, magnesium, and Excedrin(Aspirin/paracetamol/caffeine). She started taking topiramate 100 mg on 26-Mar-2021 for three months.  Company Comment: 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.; 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.
This is a spontaneous report from a contactable pharmacist via a Pfizer sales representative. This pharmacist reported same event for two patients. This is the first of two reports. A patient of unspecified age, ethnicity and gender received PREVNAR 13, via an unspecified route of administration on an unspecified date at a single dose for immunization. The patient's medical history and concomitant medications were not reported. On an unspecified date, the patient had local redness and swelling at injection site 2 days post dose of pneumococcal 13-valent conjugate vaccine (diphtheria crm197 protein). The events took place after the use of the product. The outcome of the events was unknown. No follow up attempts are possible. No further information is expected. Sender's Comments: Linked Report(s): US-PFIZER INC-2017428834 same reporter/drug/event, different patient.
Child woke from sleep coughing with inspiratory stridor.  Initially brought to Urgent Care, was not open and proceeded to ED.  Symptoms did improve with brought outside and initial thought was croup, although had no previous respiratory illness symptoms.  Stridor did occur again in ED.  In ED was given dexamethasone and racemic epi.  Discharged in improved condition.
Day 6 after COVID vaccine, woke up with right face swollen, felt strange, able to move all of face and tongue, strong extremities. Numbness increased, right eye swelling and mild drooping, slurred one word. Went to Urgent Care- then to Emergency room, MRI.  Dx: Bells Palsy.
Very painful; not just sore arm; Fever; bad chills; COVID-like fatigue; headache; This is a spontaneous report from a contactable consumer (patient reported for self). A 60-years-old (non-pregnant) female patient received bnt162b2 (PFIZER-BIONTECH COVID-19mRNA VACCINE, formulation: Solution for injection, Batch/Lot Number: EN6207, Expiry date: not reported), dose 1 via an unspecified route of administration, administered in left arm on 14Mar2021 02:45 (at the age of 60-years-old) as dose 1, single for covid-19 immunisation. Medical history included asthma, covid-19, Known allergies: scallops (allergy to animal).  Concomitant medication included fluticasone propionate, salmeterol (WIXELA INHUB) taken for an unspecified indication, start and stop date were not reported. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient was taking probiotic 1xday, Wixela 2xday within 2 weeks of vaccination. Prior to vaccination, the patient was diagnosed with COVID-19. Post vaccination, the patient has been tested for COVID-19. On 15Mar2021 07:00, the patient experienced very painful, not just sore arm, fever, bad chills, covid-like fatigue, headache (reported as, Very painful, not just sore arm. Fever and bad chills, COVID-like fatigue the whole next day with headache. Day two after (today) all better!!). No treatment received for adverse event. The patient underwent lab tests and procedures which included COVID-19 Virus Test (sars-cov-2 test): negative on Feb2021 Covid test name post vaccination: Pooled testing. The outcome of events had recovered on 16Mar2021.  No follow-up attempts are possible. No further information is expected.