chrisvoncsefalvay/vaers-outcomes huggingface dataset:
on 11/6/02, a 30 year old adult female reported receiving the following four vaccines from for traveling purposes: Typhim VI, diphtheria and tetanus toxoids, Twinrix and Yellow fever vaccine on 9/26/02. She reported that the Typhim VI vaccine was the only vaccine that hurt as it was injected. The pain lasted for 1-2 weeks and the area became discolored, turning from red to brown. Her physician did not think the reaction was important, but the pt's concern was cosmetic, as the discoloration had not resolved and was still quite visible at the time of the report.
Initial report was received 29 September 2010 from a health care professional which consisted of a cluster of three patients which involved a case of misuse. This case captures one patient, and the other two patient's have been captures in case numbers 2010-05568 and 2010-05570. A 45-year-old female patient had received a 0.1 mL intradermal left forearm injection of H1N1 (lot number unknown) at 12:00 pm on 28 September 2010 and 30 minutes later, the patient developed an itchy red lump at the injection site which measured 1.5 x 1.5 inches in size. The event did not require a doctor's visit. Outcome was reported as not recovered. Follow-up was received from a health care professional on 12 November 2010. The patient received an intradermal injection of H1N1, sanofi pasteur lot number UP076AA. The injection was intended to be a tuberculin (TB) test. The patient's symptoms of itchy red lump which was tender lasted one week and did not require a doctor's visit. The patient had no illness at the time of vaccination. The patient fully recovered on 05 October 2010. Documents held by sender: None.
fever started 3JUL (friday nite) 103 1/2, irritable-teething & diarrhea; initial impression by ER MD ear infection; pt devel red rash on body;
This spontaneous report was received from a physician via a company representative and refers to a patient of unknown age and gender. The patient's concurrent conditions and medical history were not reported. On 13-JUL-2015, the patient was vaccinated with a dose of improperly stored VAQTA (10Pk 50U/1 mL) lot number K008984, expiration date of 21-OCT-2015 (route of administration was not reported), which was stored 2 times with the following lowest recorded temepratures:34F (1.111 Celsius degrees) for 64 hours and 33F (0.555 Celsius degrees) for 16 hours. No highest reported temperatures were reported. The type of storage was refrigerator. No concomitant therapies were reported. No adverse effects were reported. No product quality complaint (PQC) was involved. This is one of several cases from the same reporter. Additional information has been requested.
mouth taste like metal; lymph nodes swollen inside throat; sores on scalp like chicken pox; fevers; chills; jaw bone locked; inside mouth was full of blisters; lip was swollen and sore, for days she could hardly open her mouth; lip was swollen and sore, for days she could hardly open her mouth; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A female patient received bnt162b2 (BNT162B2), administration date 2021 (Batch/Lot number: unknown) as dose 1, single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: DYSGEUSIA (non-serious) with onset 2021, outcome "unknown", described as "mouth taste like metal"; LYMPHADENOPATHY (non-serious) with onset 2021, outcome "unknown", described as "lymph nodes swollen inside throat"; BLISTER (non-serious) with onset 2021, outcome "unknown", described as "sores on scalp like chicken pox"; PYREXIA (non-serious) with onset 2021, outcome "unknown", described as "fevers"; CHILLS (non-serious) with onset 2021, outcome "unknown", described as "chills"; TRISMUS (non-serious) with onset 2021, outcome "unknown", described as "jaw bone locked"; ORAL MUCOSAL BLISTERING (non-serious) with onset 2021, outcome "unknown", described as "inside mouth was full of blisters"; LIP SWELLING (non-serious), LIP PAIN (non-serious) all with onset 2021, outcome "unknown" and all described as "lip was swollen and sore, for days she could hardly open her mouth".  Additional information: Caller states she has some questions and concerns, states she is also a medical personnel, states she is a scientist, states she took the Pfizer Covid vaccine three weeks ago, due for second tomorrow and she is concerned, states she is devastated and does not want to get the second one. Caller declines to provide any further personal information and does not consent to follow up. Caller states the minute after taking it her whole mouth taste like metal, states two or three hours after her lymph nodes swollen inside the throat, so swollen she could hardly see the tonsils, states her scalp had sores like chicken pox, jaw bone locked, states she had fevers and chills, states inside mouth was full of blisters, her lip was swollen and sore, for days she could hardly open her mouth. Caller declines to file the report, states she does not want to be a lab rat, does not want to be contacted about this and that. Caller wants to know if it is safe to get the second vaccine. Caller states she is allergic to some nuts. Confirms she got the Pfizer Covid vaccine, no NDC LOT and Expiration number provided, declined report.   No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Patient reported a painful arm from elbow up to shoulder and red bands of discoloration on arm as well.
she received the first dose of the covid 19 vaccine /she was diagnosed with covid 19 last Wednesday 8Feb; she tested positive for the COVID-19 infection/On 7Feb2021 she started to have COVID-19 symptoms/ She started to feel bad; This is a spontaneous report from a contactable consumer (patient). A female patient of an unspecified age received received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Formulation: Solution for injection, Lot Number: UNKNOWN) via an unspecified route of administration on 27Jan2021 at single dose for COVID-19 immunisation. Patient's medical history and concomitant medications were not reported. On an unspecified date it was reported that caller wanted to know if she could receive the second dose of the COVID-19 vaccine if she tested positive for the COVID-19 infection. She received the first dose on 27Jan2021 and her second dose is due tomorrow. On 7Feb2021 she started to have COVID-19 symptoms/ she started to feel bad and on 9Feb2021 she tested positive for the COVID-19 infection. She has been on lockdown since that and she was receiving treatment from her physician. The events were assessed as non-serious by the reporter. The outcome of events was unknown.  Information on the Lot/Batch number has been requested.
This spontaneous report was received from a register nurse concerning a 29 year old patient of an unknown gender. Medical history and concurrent conditions were not reported. On 18-MAR-2014, the patient was vaccinated with MMR II (route was not reported) lot # 0480AE, expiration date 29-AUG-2015 (also reported as 20-SEP-2014), batch number H017436, albumin status rHA. Co-suspect and concomitant therapies were not reported. The register nurse reported that MMR II went through a unsupported temperature excursion; however 10 doses of MMR II were overlooked because they were stored in the fridge. These doses were administered to 10 patients, this case pertain to one of them. This case is linked to 1404USA001099, 1404USA001100, 1404USA001101, 1404USA011002, 1403USA010165, 1404USA014293, 1404USA014295, 1404USA014296, 1404USA014297, 1404USA014298, 1404USA014299, 1404USA01430 and 1404USA014301. Additional information has been requested.
I started to have chills around 6:15ish pm, then developed a fever between 7:30-8:05 pm. I took Tylenol and now waiting for the fever to resolve.
On March 28 Mom called saying patient would not bear weight on her right side while at daycare.  No story or history of Trauma.  Parents took her to ER where the did and Xrays of her entire right leg--from hip to foot-  no findings. There were also no findings of swelling or trauma.  Sent home and told to give ibuprofen and observe. Then next day Mom called our office saying she still would not bear weight on her right leg what so ever. Seen in office by my NP- no physical findings but did draw some labs...CRP <0.3, ESR-33 and CBC WBC-15, h/h 10.9/33.7, plt. 348, 69.7 N, 23.8 L.  Patient sent home.  The next morning on 3/30 had a seizure of right upper extremity which lasted about 14 min. EMS called and she weas given IM benzodiazepine and the seizure stopped. She was post-ictal.   In ER she was afebrile, mild tachycardia and hypertension.
It came on gradually, but I felt like I had a bad flu. I was cold and my whole body ached. I slept a lot and did not want to eat. I continued feeling this way around noon Saturday. It got worse on Sunday and began to taper off. I was able to work a half day of Monday but was able to complete my job duties. It took almost a full week to feel like I recovered. I had 1 drink of alcohol on Wednesday, and it hit me extremely hard. The same thing happened on Saturday. I am not sure if it's related. I did not contact my doctor; I just toughed it out. I also did not take any medications during this time. I allowed my immune system to battle it out.
Hemorrhage like bleeding, soaked up 4 maxi pads within a 30 minute span.  Expelled Blood clots the size of apples. Went to ER. Blood loss and clots resembled the look of a miscarriage, but pregancy test, can back negative.  Multiply tests were ran. This carried on from 1:30 to 8pm, when fentaNYL and omipaque was given for pain.  Blood Pressure was also high 154/119 and temp 99.
Severe pain in left arm muscle-icing, Tylenol, Advil Headache Nausea, vomitX1
C/O onset pain around injection site approx. 1 hour after receiving Tdap - pain cont x 5 days - mostly with raising arm. No redness or swelling. Advised that this is a common side effect - should resolve. Advised to call back & contact PCP if worse.
57 yo F, healthcare worker, with history of asthma and penicillin allergy who presented to emergency department for reaction to COVID-19 vaccine. Patient received first dose of COVID-19 vaccine (Pfizer) and immediately became flushed, erythema to trunk and face, and intensely pruritic. No signs of airway involvement or wheezing. Vitals were stable. Patient was treated with benadryl which improved symptoms. Anaphylactoid reaction.
Information has been received from a certified medical assistant concerning a 25 year old female patient with no pertinent medical history and no known drug allergies who on 09-FEB-2009 was vaccinated S.Q with a 0.5 mL first dose of GARDASIL (lot # 661952/1129X), on 22-APR-2009 she received IM a second 0.5 mL dose of GARDASIL (lot # 658271/0558X) and on 02-SEP-2009 was administered with a third 0.5 mL dose of GARDASIL (lot # 662229/1497X). There was no concomitant medication. On 09-FEB-2009, after administration of the first dose of GARDASIL, the patient experienced bruising and pain at the site of injection. The patient was seen for office visit. No laboratories or diagnostics studies were performed. At the time of reporting the patient had recovered. The health care professional contacted during telephone follow-up could not supply the following information: dates of vaccination and lot number. Additional information has been requested.
Sweats; Vertigo; Tenderness; Pain in the arm; Pain in the shoulder; Pain in the left breast; Pretty much all the symptoms of covid except loss of taste and smell; Could not walk; Headache; Fatigue; Could not roll out of bed; A spontaneous report was received from a consumer concerning a female patient who received Moderna's COVID-19 vaccine (mRNA-1273) and experienced events could not walk, headache, fatigue, could not roll out of bed, sweats, shakes, vertigo, tenderness, pain in the arm, pain in the shoulder, pain in the left breast, pretty much all the symptoms of covid except loss of taste and smell.  The patient's medical history was not provided. No relevant concomitant medications were reported.  On 5 Feb 2021, prior to the onset of the events the patient received their first of two planned doses of mRNA-1273 (lot/batch: Not provided) intramuscularly in the left arm for prophylaxis of COVID-19 infection.  On 6 Feb 2021, the patient experienced the events could not walk, headache, fatigue, could not roll out of bed. On 7 Feb 2021, the patient experienced the events sweats, shakes, vertigo, tenderness, pain in the arm, pain in the shoulder, pain in the left breast, pretty much all the symptoms of covid except loss of taste and smell.  No treatment information was provided.  Action taken with mRNA-1273 in response to the events was not reported.   The outcome of events, could not walk, headache, fatigue, could not roll out of bed, sweats, shakes, vertigo, tenderness, pain in the arm, pain in the shoulder, pain in the left breast, pretty much all the symptoms of covid except loss of taste and smell was unknown.
Upper (L) arm, swollen, red and increased warmth to touch. Feels ok other than the arm feels tight. No breathing problems + 3-4 swollen with fluid in the dependent area is + 2-3 erythemic-no itching no pain. Starts 1" below injection site
I got sick after the 2nd shot; it was one day of feeling uncomfortable; This spontaneous case was reported by a physician and describes the occurrence of ILLNESS (I got sick after the 2nd shot) and FEELING ABNORMAL (it was one day of feeling uncomfortable) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     Concurrent medical conditions included Rheumatoid arthritis. Concomitant products included CELECOXIB (CELEBREX) and HYDROXYCHLOROQUINE SULFATE (PLAQUENIL S) for Rheumatoid arthritis.    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, the patient experienced ILLNESS (I got sick after the 2nd shot) and FEELING ABNORMAL (it was one day of feeling uncomfortable). At the time of the report, ILLNESS (I got sick after the 2nd shot) and FEELING ABNORMAL (it was one day of feeling uncomfortable) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   Treatment information was not provided.  Patient was an ophthalmologist. She was  now at the 8 month point since her 2nd Moderna dose. She was in the high risk category and says that it is scary to go back to work and not have a booster dose yet. She said that her colleagues who received the Pfizer are being protected by the booster shot, but not the Moderna consumers.
Extreme fatigue 3 to 4 times a week, must lay down for several hours and rest Brain fog, short-term memory loss  Muscle and joint pain
Extreme Fatigue, headache, stomach ache, swollen tongue, ankle swollen, constipation, limited cognition, unsteady gate, loss of appetite.  Weird feeling in head to the point of losing focus and almost passing out.  Severe symptoms lasted for five days until 2/6/21.  Currently limited fatigue, slight cough.
Pt received vaccine Monday (12/5/11) Wed AM woke up with red lump very large (size of palm) at site of inj. warm to touch Wed/Thurs felt lousy "not herself". By Sat 12/10/11 feeling better now egg sized. No longer warm. Will follow up again 1 week.
COVID 19 Treatment; COVID 19 Treatment; This is a spontaneous report received from a non-contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 77-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 25May2022 as dose 4 (booster), single (Batch/Lot number: unknown) at the age of 77 years 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 and concomitant medications were not reported. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant) all with onset 2022, outcome "not recovered" and all described as "COVID 19 Treatment". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (2022) Negative; (Jul2022) Positive, notes: tested positive 4 days after finishing the Paxlovid course; (2022) positive. Therapeutic measures were taken as a result of drug ineffective, covid-19.  Additional information: After getting better and testing negative for SARSCov2 virus, I started with symptoms and tested positive 4 days after finishing the Paxlovid course. Symptoms improved quickly but I am still testing positive on RAT 19 days after the first positive.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
AT APPROXIMATELY 10:37 AM PATIENT REPORTED SWELLING IN HIS RIGHT HAND AND FELT SOME DIZZINESS.  PATIENT WAS CHECKED FOR BLOOD PRESSURE AND OXYGEN LEVEL.  PATIENT WAS ALSO GIVEN A DOSE OF DIPHENHYDRAMINE 25 MG AND PREDNISONE 10 MG.  AT 10:50 AM PATIENT WAS RECHECKED AND SWELLING OF HANDS AND DIZZINESS SYMPTOMS HAD RESOLVED.
brought into the emergency department after having a fall while he was trying to get out of bed, patient reports feeling lightheaded.  Denies loss of consciousness or hitting his head.  Patient had fever, sore throat dry cough for a week, he tested positive for COVID on 08/23
5/23/03 At place where Varivax given on 5/13/03, long, raised, red area about 25 cent size. Does not bother child. By 4:00 PM, Mom reported 2-3 tiny blisters at site. Still does not bother child - no itching.
Itchy eyes, watery eyes, nasal congestion, area under tongue swollen, chills, body aches, sweats. All resolved by 5:00 AM.
Site: Itching at Injection Site-Severe, Site: Redness at Injection Site-Medium, Systemic: Headache-Medium, Systemic: blisters on neck, lathargic,appetite
At 0944 11/9/20, CMA gave this 2 year old patient Flulaval (lot #99J23) IM in his left lateral thigh. NDC 19515-816-52.  Exp date 6/30/21.   That evening, area was painful and erythematous.  Rash worsened and mother sent photos of the area.  Patient came to clinic for MD assessment on 11/11 and rash had improved.  Described as diffuse, patchy erythematous rash with swollen painful injection site.  Site was blanchable.  Area was nonpruritic.  Plan to treat with antihistamine.  No harm.
Called to observation area due to patient concern about metallic taste in mouth starting about 15 minutes after injection. Heart RRR no murmur not tachycardic, lungs CTAB. No ShOB, chest pain, tightness, N/V or other symptoms. She is taking azithromycin and prednisone currently. Has been taking the prednisone in AM, took dose today and has two left. Instructed her to take next prednisone this evening and last one tomorrow PM. Instructed to call the clinic or present to ER if any new issues.
April on 9th, 2022, I started to have a terrible stomachache. I have chronic pain so I thought it was that but it wasn't. I couldn't do anything because of the pain. Then I started to notice blisters. Which would have been an internal outbreak of herpes. I called Dr. once I realized I had the blister and he wrote me a prescription for valacyclovir 1gram. I took one tablet by mouth 3 times a day, for 7 days. It took about 8-10 for the blisters to appear on the outside of my sink. I am on my second set of prescription for valacyclovir. I did not go into into the doctors.
Initial information received on 26-Nov-2018 regarding an unsolicited valid non-serious case received from a nurse. This case involves a 9 months old patient who received the 0.5 ml FLUZONE QUAD instead of the 0.25 ml, while he/she received vaccine FLUZONE QUADRIVALENT. The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided. On 26-Nov-2018, the patient received a once 0.5 ml dose of suspect INFLUENZA QUADRIVAL A-B VACCINE lot U6260AA via unknown route in the left thigh. It was a case of actual medication error due to overdose. The patient outcome is reported as Not Applicable for 9 month old patient received the 0.5 ml FLUZONE QUAD instead of the 0.25 ml. This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holder's 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.
C/o left arm red, face red, back and stomach itchy. 100mg benadryl given at 6:25pm. Pt recd inj at 5:30pm. began with local reaction that spread to abdomen and face. Benadryl given at school then pt presented to ED.
developed breakthrough covid infection in april which necessitated monoclonal antibody infusion; developed breakthrough covid infection in april which necessitated monoclonal antibody infusion; This is a spontaneous report from a contactable physician (patient). A 60-year-old male patient received first dose of BNT162b2 (PFIZER BIONTECH COVID-19 mRNA VACCINE, Solution for injection), Lot number- EL0140) via an unspecified route of administration in left arm on 20Dec2020 as dose 1 single and received second dose of BNT162b2 (PFIZER BIONTECH COVID-19 mRNA VACCINE, Solution for injection), Lot number: EK9231) via an unspecified route of administration in left arm on 10Jan2021 as dose 2 single for COVID-19 immunization. Patient age at vaccination was 60 Years. Medical history included hypertension, hypercholesterolemia, know allergies: sulfa. Concomitant medications within 2 weeks of vaccination included rosuvastatin calcium (CRESTOR), lisinopril, Indapamide, vitamins. Prior to vaccination, the patient was not diagnosed with COVID-19. Facility where the most recent COVID-19 vaccine was administered was hospital. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. On 24Apr2021, the patient developed breakthrough COVID infection in April which necessitated monoclonal antibody infusion. Adverse event resulted in Emergency room/department or urgent care. Patient received treatment with monoclonal antibody infusion. Since the vaccination, the patient had been tested for COVID-19 PCR test via Nasal Swab resulted positive on 24Apr2021. The outcome of the events was recovered on an unspecified date in 2021.; Sender's Comments: Based on the current limited available information and the drug-event temporal association, a possible contributory role of the suspect product BNT162B2 to the development of events of vaccination failure and COVID-19 cannot be totally excluded/assessed.