chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Runny nose; Slight cold; This spontaneous case was reported by a consumer and describes the occurrence of RHINORRHOEA (Runny nose) and NASOPHARYNGITIS (Slight cold) in a 65-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 015M20A) for COVID-19 vaccination.     Concurrent medical conditions included Hypertension.    On 12-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced RHINORRHOEA (Runny nose) and NASOPHARYNGITIS (Slight cold). The patient was treated with GUAIFENESIN (MUCINEX) at an unspecified dose and frequency; PARACETAMOL (TYLENOL) at an unspecified dose and frequency and DIPHENHYDRAMINE HYDROCHLORIDE (BENADRYL [DIPHENHYDRAMINE HYDROCHLORIDE]) at an unspecified dose and frequency. At the time of the report, RHINORRHOEA (Runny nose) and NASOPHARYNGITIS (Slight cold) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Concomitant product use was not provided by the reporter.  They consulted with their HCP who thought that they could attend but advised the patient to call Moderna.
Immediately after the 2nd Moderna vaccine, I developed an acute genital ulcer (Lipschütz ulcers). It was extremely painful and cleared after a month. I got the ulcer the day after the vaccine, and I photographically documented it as it progressed and healed. I saw an OBGYN and I was tested for STDs and they swapped the ulcer for herpes virus and all tests came back negative.   I have seen Lipshütz ulcers connected to COVID 19 virus, but not the vaccine.   I have never received a positive COVID test, and I don't think I have ever had COVID.
Fever of 100.6-102.0 and vomiting.  It has been more than 24 hours since the injection, but not yet 48 hours, symptoms persist.
Pt had immunization 9/26 and Barium x-ray 9/27. Pt was seen due to rash and diagnosed with urticaria (vaccine vs Barium). Pt was treated with Benadryl, 3cc by mouth every 6 hours. Visit with doctor 4 days after onset revealed rash has resolved.
Swelling at site of injection but only on one side; This is a spontaneous report from a contactable nurse. The reporter reported 2 reports for different patients. This is the first of 2 reports. A female patient of an unspecified age received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection), dose 1 via an unspecified route of administration on Mar2021 (Batch/Lot number was not reported) as a single dose, dose 2 via an unspecified route of administration on Apr2021 (Batch/Lot number was not reported) as a single dose for covid-19 immunization; hyaluronic acid, lidocaine (RESTYLANE LYFT), via an unspecified route of administration from Apr2021 (Batch/Lot number was not reported) to an unspecified date, at unspecified dose for an unspecified indication. The patient medical history was not reported. The patient's concomitant medications were not reported. The patient previously took Lyft from Aug2020. The patient experienced swelling at site of injection but only on one side on 2021. Last had Lyft in Aug2020 and Apr of this year 2021. Vaccines in late Mar2021 and early Apr2021. Treated with Benadryl and Ibuprofen. The action taken in response to the event for hyaluronic acid, lidocaine was unknown. The outcome of the event was unknown.  Information on the lot/batch number has been requested.; Sender's Comments: Linked Report(s) : US-PFIZER INC-2021749519 Same reporter/drug/AE, different patient
The adverse reaction is hives. They started occurring in 3 different ways. They were happening in red, hot, itchy patches in my elbows and knees. They also would be classic hives. The third way is long, slash marks. They often appear symmetrically on both sides of my body. From November to about February, they were constant. I was having between 5 and 10 flareups a day but they appeared and disappeared fairly quickly. A flareup would last about 20 minutes. The itching responded well to Aveeno skin cream. From February to now, they've gotten progressively better. Breakthrough Case of Covid: I travelled for work from May 1st-6th. I became symptomatic on the 7th. On the 8th, I had a fever of 99.8, had a very sore throat, aches and pains, and was tired. On Sunday, I took an at home test and was negative. I felt like I had a cold Monday and Tuesday. Just felt run down and had a dry cough. My husband because symptomatic on Wednesday of last week, the 11th. On the 12th, he was quite sick. We did an at home test on him and he tested positive. We went to our Urgent Care facility. The doctor we spoke to told us the at home test is very reliable when it's positive and that we should assume I was also positive. We are isolating for 10 days. At this point, we feel 90% back to normal.
In August 2022, I started having pain in my neck. I thought it would go away, so I waited to consult with my doctor. In December, I lost hearing on my left side. I was having headaches 24/7, he did not run any test or give any medication. In January I went back to the doctor to let him know I was still dealing with the headaches; he advised me to take Tylenol and Ibuprofen. I awoke one night with an excruciating pain in my eye, I went back to the doctor and told him I could not deal with this pain. I was given Azithromycin any possible infection I may have.
Body aches, sore arm, covid arm symptoms - raised itchy red patch in around injection site that is warm to the touch. Body aches subsided by Friday (2 dqys) . Covid arm symptoms still present.
Headache, Myalgia & Fever Narrative:  Patient received vaccine on 3/9/21 and began experiencing symptoms that evening. Reported symptoms include fever (100 F), headaches, body aches, chills, and menstrual cramps. Reported took Tylenol (no dose, frequency provided). Did not see PCP for symptoms.  Other Relevant History:
excursion could have been caused by someone tampering with the refrigerator/ IPOL exposed to temperatures between 315.5 farenheit and 32 farenheit for 10 minutes and out of range till 11 july; Initial information received on 25-Jul-2019 regarding an unsolicited valid non-serious case received from a nurse by phone and additional information was received on 25-Jul-2019.  This case involves a 17 years old male patient who was vaccinated with a 0.5 ml dose of IPV (VERO) [IPOL] (Batch number: 979860 and expiry date: 26-Apr-2020) via unknown route in the right arm on an unknown date.  The patient's past medical history, medical treatment(s), vaccination(s), family history and concomitant medications were not provided.  It was a case of actual medication error due to product storage error temperature too high because IPOL exposed to temperatures between 315.5 Fahrenheit and 32 Fahrenheit for 10 minutes and out of range till 11 July.   It was unknown if any adverse event occurred or not following the vaccination.  This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holders compliance with the requirements set out in Directive 2001/83/EC and Module VI of the Good Pharmacovigilance Practices. The classification as a medical error is in no way intended, nor should it be interpreted or construed as an allegation or claim made by the marketing authorization holder that any third party has contributed to or is to be held liable for the occurrence of this medication error.   Documents held by the sender: none.
Swelling, redness, heat at injection site a few hours after immunization. Hives pt took Benadryl to reduce symptoms. Reported adverse effect to Pharmacy the next day.
I was diagnosed with an autoimmune disease experienced tingling, weakness, and balance issues due to this this and symptoms has worsen after the vaccine.
Information has been received from a medical assistant referring to a 13 years old female patient. The patient had no concomitant medication, pertinent medical history or drug reactions/allergies. On 25-JUL-2016, the patient was vaccinated with a dose of PROQUAD (lot #, expiration date, dose and route were not reported). On an unknown date in July 2016, the patient experienced sore throat and swollen lymph nodes following the administration of PROQUAD. The patient sought medical attention on an unknown date in July 2016. It was reported that treatment was given in the form of an unspecified dose of TYLENOL to treat the patient's symptoms on an unknown date. No lab diagnostics studies were performed. The outcome of the events was unknown. The causality was not reported. Additional information has been requested.
This spontaneous report as received from a medical assistant refers to a patient of unknown age and gender. Pertinent medical history, drug allergies or reactions were not reported. On 02-OCT-2014, the patient was vaccinated with a dose of (Oka/Merck) PROQUAD lot # K008185, expiry date: 05-DEC-2015 (dose and route were not reported) that underwent temperature excursion. Concomitant medication was not reported. No adverse effect reported. This is one of several reports received from the same source. Additional information has been requested
severe joint and muscle pain lasting for months. significant fatigue.  brain fog.  elevated heart rate
Pt experienced induration redness, edema left deltoid 1 day after receiving vaccine in left deltoid (DTaP). No anaphlaxis. No fever. Pain.
Since the vaccination and now two weeks later, I am experiencing dizziness and lightheadedness, and unbalance.  Also, a general unwell feeling, fatigue, extreme sleep disturbance, and temperature regulation difficulty, especially at night.   NONE of these symptoms were present at all in any form before the vaccine.
Arm where IZ became increasingly red and warm the next day. Redness and warmth continued to increase through the week. On 03/09, saw physician and received cortisone injection.
Several months after the vaccine I developed left ear tinnitus. I saw an ENT specialist who performed an MRI and MRV of my left ear canal to rule out any clot and my hearing was also performed but was within normal ranges. And so far I am still experiencing it and to date there has been no reason as to why the tinnitus even developed.
This case was considered medically important. Information regarding Prevnar (pneumococcal 7-valent conjugate vaccine (diphtheria crm197 protein) injection) was received from a pediatrician regarding 4 or 5 pt's (gender unspecified), who received a third or fourth dose of Prevnar on an unspecified date and developed a fever, leukocytosis and pneumococcal-like illness suggestive of pneumococcal infection. Relevant medical history was not provided. Indication for Prevnar was immunization. Product was administered on an unspecified date. Dose regimen was 1 dose. Concomitant medications were not reported. On an unspecified date, 4 or 5 pt's received a third or fourth dose of Prevnar. Subsequently, on an unspecified date, the pts developed a fever (pyrexia), characterized by a temp of 104 degrees F and leukocytosis. The reporter indicated the children developed a pneumococcal like illness suggestive of a pneumococcal infection. Blood cultures were performed on an unspecified date and the results indicated that no pneumococcal isolates were found. Treatment included one dose of Rocephin. The reporter indicated the pt's responded within 24 hrs and recovered. The reporter questioned a reduction in efficacy with Prevnar (drug ineffective) stating, 4 or 5 children who have received 3 or 4 doses of Prevnar have developed pneumococcal like illnesses. The reporter indicated that approx 5 pt's experienced this event; however, they are not presently identifiable. Additional reports will be generated when identifying information is provided. Blood culture was done on an unspecified date. No additional  information was available at the time of this report.
soreness on her arm/ sore arm; felt very cold; weird sensation which she can't fully explain. It was like electrical impulses all over her body started appearing and like her blood is running inside all over her body; heart rate went a little fast, recorded at 110-112; could not sleep; This is a spontaneous report from a contactable Nurse. A 60-year-old female patient received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE, Solution for injection), via an unspecified route of administration on 01Mar2021 (Batch/Lot Number: EN6205; Expiration Date: Jun2021) as 1st dose, single dose for covid-19 immunisation. Medical history included covid-19 from 27Nov2020 to an unknown date and aggressive fever. The patient's concomitant medications were not reported. The patient previously took albuterol, tylenol and mucinex for covid-19. The patient reported that she was fine after 1st dose of the Pfizer vaccine but experienced some soreness on her arm and took tylenol. When she got home, she felt very cold but did not have a fever and had a normal temperature. As she was laying down, she felt a weird sensation which she can't fully explain. It was like electrical impulses all over her body started appearing and like her blood is running inside all over her body. Her heart rate went a little fast, recorded at 110-112 while her normal is 100-110. She could not sleep because of this. She woke up today and mentioned that her symptoms are lessening, not as intense as they were last night, and there is a little improvement. She took Tylenol for her symptoms and did not go to work. She received the vaccine amidst having a previous COVID Diagnosis last thanksgiving, 27Nov2020 and stated that she may still have antibodies from her infection and that the vaccine might be interacting with it. She knew that the Pfizer vaccine was not tested in people with previous COVID Diagnosis and just followed the CDC's recommendation to get vaccinated after 90 days after the infection and inquired for information, Pfizer may have on these topics and if she should receive the 2nd dose on 22Mar2021. She had covid around thanksgiving being about 3 months ago, so she waited the 90 days to get the vaccine. She reported that since she was a covid patient, she was thinking is it because she had antibodies. She was checked 2 weeks in Feb2021 and she was positive for antibodies and wanted to know the relationship between antibodies and the vaccine. Therapeutic measures were taken as a result of soreness on her arm/ sore arm. The patient underwent lab tests and procedures which included heart rate: 110-112, heart rate went a little fast, recorded at 110-112 while her normal is 100-110, sars-cov-2 antibody test: positive on Feb2021. The outcome of the events was unknown.  No follow-up attempts are possible. No further information is expected.
Hospitalized for Myocarditis 1 day after receiving booster. Previous vaccinations 5/19/21, 6/09/21, Booster 1/14/21
Vaccine administration site became puffy and has continued to become puffier. It is about the size of golf ball, [itchy and burning].; Vaccine administration site became [puffy and has continued to become puffier. It is about the size of golf ball,] itchy [and burning].; Vaccine administration site became [puffy and has continued to become puffier. It is about the size of golf ball, itchy and] burning.; This is a spontaneous case, reported by other health professional via Agency (reference number: SEQ19-05374) and initially received on 23-Oct-2019, concerning a 48-year-old, female patient.  The patient's relevant medical history included diabetes and lupus. Concomitant medications were not reported.   On 23-Oct-2019, the patient was administered Flucelvax QIV [influenza vaccine, subunit influenza virus vaccine polyvalent, dose: 0.5 ml, route of administration: intramuscular, anatomical location: right deltoid, batch number: 262637, expiration date: 30-Jun-2020] for influenza prophylaxis.   On the same day, unknown period after vaccination, the patient's vaccine administration site became puffy and has continued to become puffier. It was about the size of a golf ball, itchy and burning. The patient was treated with ice to the site.  At the time of the initial reporting, the outcome of all events was not recovered.  The case was assessed as non-serious. The reporter did not provide causality assessment to Flucelvax QIV.  Company comment: All events are considered related to Flucelvax QIV.; Sender's Comments: All events are considered related to Flucelvax QIV.
The day after vaccination, I have horrible body aches,; Chills; Low fever; Nausea; Diarrhea; This is a spontaneous report from a non-contactable consumer, the patient. A 24-year-old female patient received the second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: FA6780) via an unspecified route of administration in the left arm on 19Jul2021 at 14:15 (at the age of 24-years-old) as a single dose for COVID-19 immunisation. Medical history included asthma and known allergy to penicillin. Prior to the vaccination, the patient was not diagnosed with COVID-19.  Concomitant medications included fluoxetine hydrochloride (PROZAC) for an unknown indication and combination birth control pill; both from an unknown date and unknown if ongoing. The patient did not receive any other vaccines within four weeks prior to the COVID vaccine. The patient previously received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EW0191) via an unspecified route of administration in the left arm on 28Jun2021 at 14:15 (at the age of 24-years-old) as a single dose for COVID-19 immunisation. On 20Jul2021 at 03:00, the day after vaccination, the patient experienced horrible body aches, chills, low fever, nausea, and diarrhea. It came on very suddenly at 03:00. The event did not result in doctor or other healthcare professional office/clinic visit, emergency room/department or urgent care. Therapeutic measures were taken as a result of the events and included treatment with over the counter (OTC) pain medicine. Since the vaccination, the patient had not been tested for COVID-19. The clinical outcome of the events horrible body aches, chills, low fever, nausea, and diarrhea were resolving at the time of this report.   No follow-up attempts are possible. No further information is expected.
Irritability, trouble sleeping, anxiety, can't sit still starting the day after the vaccination. Was seen in ER and given XANAX. F/u with PCP and given acetaminophen PRN.
This spontaneous report as received from a Certified Medical Assistant refers to an unspecified number of patients of unknown age and gender. Pertinent medical history, concurrent conditions, drug reactions or allergies were not reported. On an unknown date the unspecified number of patients were vaccinated with improperly stored doses of RECOMBIVAX HB (dose, dose number, route, anatomical location, lot number and expiration date were unspecified). Concomitant therapies were not reported. No adverse symptoms reported. This is one of several reports received from the same reporter. Additional information has been requested.
I was having cold spells, headache, low grade fever, and cough. I tested positive for COVID. It felt a little like the flu. It lasted about 5 days.
Redness, warmth, slight swelling of large part of right upper arm. Discomfort since 10/11/06 (date of injection), erythema developed 10/16/06.
On 04/07/1998 the patient developed a fever and rash. The patient received treatment with therapy of Atarax and recovered. In July, 2000 the patient developed breakthrough chickenpox with approximately 15 lesions. She was afebrile at that time. It was unknown if the child was exposed to wild type virus. The patient sought unspecified medical attention. The child has since recovered. No further information is expected.
She had to visit the doctor because she was experiencing vomiting, diarrhea, fever of 100-101 and chills. She said it was from day 3 to day 7.
Treatment of COVID-19; Treatment of COVID-19; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 79-year-old male patient received BNT162b2 (BNT162B2), on 05May2022 at 14:30 as dose 4 (booster), single (Batch/Lot number: unknown) at the age of 78 years, in left arm for covid-19 immunisation; 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 immunisation. The patient's relevant medical history was not reported. Concomitant medication(s) included: SYNTHROID; DUTASTERIDE; LIPITOR; PROZAC; B12 [CYANOCOBALAMIN]; PREGABALIN; ZYRTEC [CETIRIZINE HYDROCHLORIDE]; DONEPEZIL. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant), outcome "unknown" and all described as "Treatment of COVID-19". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: Positive. Therapeutic measures were taken as a result of drug ineffective, covid-19.  Clinical course: The patient received vaccine. The patient received other medication in two weeks. Synthoid, Dutesteride, Lipitor, Prozac, B12, pregabalin, Zyrtec and donepezil. The patient experienced Full itchy body rash on 03Oct2022 with outcome Not Recovered. The patient received Oral Prednisone as a treatment for Full itchy body rash. The patient received Paxlovid as Covid-19 treatment from 01Oct2022 to 03Oct2022.  The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.
Janssen COVID-19 VACCINE EUA -  Initial arm soreness that still is tender like a bruise 3 says following the injection.  Started aching all over a few hours later.  That continued through the night and following day.  Had a low grade fever, even after taking ibuprofen the next morning and throughout the day. Lots of fatigue from the day of injection until now, but is improving.
approx 13 days p/vax pt devel a varicella rash. rpt MD felt that varicella rash was not related to therapy w/varicella virus
Fever of 102.8 F rectally at 1906 on 3-27-17, took to local ER for evaluation. Fever down to 100 F 3-28-17 at 16:16.
Redness, wide spread rash, itching. Prescribed triamcinolone,  followed by prednisone , prednisone 15mg/5ml, two different times,  last Rx 5/15. Patient is gaining weight despite no changes in diet or exercise,  has wide spread joint pain.
painful; This case was reported by a consumer via interactive digital media and described the occurrence of pain in a patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   Previously administered products included COVID-19 vaccine (1st and 2nd dose received couple of years ago from the date of reporting), DTPA vaccine (received couple of years ago from the date of reporting) and Flu vaccine (received couple of years ago from the date of reporting).   On 21st August 2021, the patient received the 1st dose of Shingles vaccine. On an unknown date, less than a year after receiving Shingles vaccine, the patient experienced pain. On an unknown date, the outcome of the pain was unknown.   It was unknown if the reporter considered the pain to be related to Shingles vaccine.     Additional Information: This case was considered as invalid as unspecified adverse event was reported (It was no cake walk...I had a pretty rough 24 hours- refers unspecified adverse event as we can't assume feeling abnormal).   Follow-up information received on 20th June 2022. This follow-up was considered significant. Reporter's comment: The patient stated it was nothing as painful as the Shingles vaccine. The patient stated that he/she had 2 Covid vaccines, TDPA and the flu shot in the past couple of years from the date of reporting. The patient also stated that his/her mom and brother got it (Shingles vaccine) and it was horrible. Summary of Changes: This case became valid with the addition of the follow-up information. The case classification changed. The new event pain was added with its causality narrative details were updated.