chrisvoncsefalvay/vaers-outcomes huggingface dataset:
tested positive on 04Sep; tested positive on 9/4; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) from product quality group. The reporter is the patient.  A 53-year-old male patient received BNT162b2 (BNT162B2), on 25Feb2021 as dose 1, single (Lot number: EN6202), on 18Apr2021 as dose 2, single (Lot number: EN6204) and on 27Aug2021 as dose 3 (booster), single (Lot number: EW0179) at the age of 52 years for covid-19 immunisation; elasomeran (MODERNA COVID-19 VACCINE), on 09Apr2022 as dose 4 (booster), single (Lot number: 003K21-2!) for covid-19 immunisation. The patient's relevant medical history included: "Hypertension" (unspecified if ongoing); "overweight" (unspecified if ongoing). There were no concomitant medications.  The following information was reported: DRUG INEFFECTIVE (medically significant) with onset 04Sep2022, outcome "not recovered", described as "tested positive on 04Sep"; COVID-19 (medically significant) with onset 04Sep2022, outcome "not recovered", described as "tested positive on 9/4". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (unspecified date) Positive, notes: at home Covid tests barely registered positive; (unspecified date) Positive, notes: Monday night the test came back with a definite positive; (04Sep2022) Positive, notes: I tested positive on 04Sep. Therapeutic measures were taken as a result of drug ineffective, covid-19.  Clinical course: The patient did not received any other medication in 2weeks. The patient had no known allergies. He tested positive on 04Sep and began 5 day treatment same day, he finished on thursday- at home covid tests barely registered positive over the weekend, felt pretty good- monday night the test came back with a definite positive and by tuesday morning- he felt like he did last week tuesday morning- he felt like he did last week fatigue- and lots of congestion in the sinuses. Treatment start date: 04Sep2022. Treatment stop date: 08Sep2022.; Sender's Comments: Linked Report(s) : US-PFIZER INC-202201160311 same product, patient, different AEs, different dose;
Muscle ache; This spontaneous case was reported by a consumer and describes the occurrence of MYALGIA (Muscle ache) in a 72-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 031L20A and 030L20A) for COVID-19 vaccination.     Concurrent medical conditions included Blood pressure.   On 28-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 25-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 25-Feb-2021, the patient experienced MYALGIA (Muscle ache). The patient was treated with PARACETAMOL (TYLENOL) at an unspecified dose and frequency. On 28-Feb-2021, MYALGIA (Muscle ache) had resolved. Not Provided      For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   Concomitant medication include blood pressure medications. Treatment include Tylenol   This case was linked to MOD-2021-027347 (Patient Link).
have had two shots for shingles / A year later I have the shingles/ suspected vaccination failure; shingles; This case was reported by a consumer via media and described the occurrence of suspected vaccination failure in a patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   Co-suspect products included Herpes zoster (Shingles vaccine) for prophylaxis.   On an unknown date, the patient received the 2nd dose of Shingles vaccine and the 1st dose of Shingles vaccine. On an unknown date, 1 year after receiving Shingles vaccine and more than a year after receiving Shingles vaccine, the patient experienced vaccination failure (serious criteria GSK medically significant) and shingles. On an unknown date, the outcome of the vaccination failure was unknown and the outcome of the shingles was not recovered/not resolved.   It was unknown if the reporter considered the vaccination failure and shingles to be related to Shingles vaccine and Shingles vaccine.  Additional details were reported as follows: The case was reported by the patient. The age at vaccination was not reported. The patient had 2 shots of Shingles vaccine and a year later the patient had the shingles today. The patient stated that, no shot was 100 percent but he/she guess it helped a little. This case was considered as suspected vaccination failure as details regarding, laboratory confirmation were unknown at the time of reporting.
The patient was given an expired COVID shot. The vial was only good for 12 hours upon puncture. The vial was opened on 09/19/2022 at 16:50pm so it was expired when it was administered at 8:33am on 09/20/2022. The error was discovered right away and notified the patient and the provider. The patient was given another COVID Bivalent shot.
I had a fever in the middle of the night, but no pain at the injection site. On Monday, January 25  my arm and part of my back felt like they were burning/itching and were sensitive to clothing and clothing tags. Not anything major or that i'm too concerned about, but wanted to know if any others have experienced this as well. My skin isn't red and there's no rash- it is only hypersensitive to touch. I don't have any food allergies or any allergies to medicines. I've never had adverse reactions from a vaccination before and my skin is typically not sensitive to anything.
Patient was given an expired vaccine the date of  6/15/22 and vaccine had expired 5/24/22. Patient has not reported any symptoms therefore no treatment has been given.
This was a medication error.  The RN vaccinator mistakenly administered an adult dose of Pfizer vaccine to this 9-year old patient.  This was the patient's 2nd dose.  He received Pfizer Pedi 5-11 formulation for his first dose on 01/05/2022.  Mother was informed of the mistake and counseled. Patient was monitored and showed no signs of distress.  Public Health was contacted and was going to contact the mother to follow up.
Pt said she had a allergic site reaction where she had the vaccination in her arm. The patient's arm was a little swollen and red.
Patient 17 years old, underage 18 per manufacturer guidelines. No reported side effects after vaccination.
Sore arm (in the arm that I got the injection)  and chills starting about 10 hours after the shot and lasting about 24 hours. It self-resolved and I didn't take any medications for these side effects.
Child fainted and hit head on table after receiving 3 vaccines (Tdap, MENACTRA, HPV) was out briefly - recovered in our clinic - no trip to dr or hospital.
2nd dose Moderna COVID19 Vaccine, reported feeling nauseous and dizzy within 5 minutes of the vaccine. Pt reported she did fine with her first dose. Allergic to Penicillin and Morphine. BP 130/90 HR 86 O2Sat 98% Repeat 145/80 HR 80 O2sat 97%  Symptoms not resolving EMS called at 1:18 PM. EMS arrived at 1:20 PM. Evaluated by EMS. Pt refused transfer to hospital, signed refusal with EMS. Pt was advised to call her MD and given ED precautions. Sips of water tolerated. Light headedness resolved, nausea persisted. Pt?s sister drove pt home.
After the first dose on January 26, I had pain and redness at the injection site. I believe this has the name Covid arm. After the second dose on February 23 I had chills, fatigue, headache, body aches, loss of appetite, pain at injection site, lasting under 24 hours.  My primary reason for reporting my symptoms is because on March 18, exactly three weeks after experiencing the initial reactions, I had the exact same reactions again only much worse and lasting four days. I took a Covid test, which came back negative, and after chatting with my doctor, decided to report my symptoms to you at her suggestion. She had not heard of anyone reporting two lots of symptoms.
Patient presented to the office for third dose of covid-19 vaccination and conjunctivitis on 11/30/22 at 4:25 PM. After administration of covid-19 vaccine, it was determined that the the third dose of Pfizer covid-19 vaccination was administered in error as it was given 7 days early based on minimal spacing interval of 2 months from second dose. If taking into account, the 4 day grace period for vaccination, the vaccine was still given 3 days early and is therefore invalid. I called and disclosed the medical error to patient's mother on 12/3/22 at 11:30 AM. I discussed that the vaccine will be marked as "in error" and is considered invalid per guidelines. I discussed that per the guidelines, they recommend repeating the dose in 2 months. I also informed mother that we will continue to monitor for vaccine booster guidance as it comes out over the next few months. Mother reports that patient is well appearing, active and energetic and is not currently experiencing any side effects of the vaccination.   I advised the family to call if any side effects/adverse reactions occur. I also informed her that I will be filing a report and will report the vaccine in error. Encouraged family to call w/ any further questions or concerns.
5 minutes after MMR given employee complained of pain all along left arm, up into her neck and left fingers tingling. Had her sit to observe her. 5 minutes later stated she "did not feel well", and started retching. She then became more agitating stating "I can't breathe". Told bystander to call 911, RNs administered .5cc epinephrine, 25 mg po benadryl. Employee became lethargic, had her lie on the floor until ambulance personnel arrived. Sent via ambulance to ED. ED monitored her and discharged her to home. ED Physician stated "probable vasovagal reaction" versus anaphylaxis.
Measles vax @ 1145am; shellfish @ lunch onset 220pm approx of nausea; 245 hands red swollen, felt hyper, SOB. "hives" on arms-to ER. D/C to home w/meds
Information has been received from a pharmacist referring to a 17 year old patient of unknown gender. The patient's concurrent condition, medical history and concomitant therapy were unknown. On 12-SEP-2017, the patient was vaccinated with the first dose of GARDASIL 9 (dose, frequency, route, lot# and expiration date were unknown) for prophylaxis. On 09-OCT-2017, the patient was vaccinated with the second dose of GARDASIL 9 (dose, frequency, route, lot# and expiration date were unknown) for prophylaxis(inappropriate schedule of drug administration). There was no adverse effect reported.
2nd dose I got red and swollen rash. Few hours later it developed a hard ball under it and got bigger. Sore to the touch. 2nd day was about a quarter in size red, swollen and hard knot under, sore to the touch. Day 3 bigger the hard area also bigger still sore to touch, slightly itchy .day 4 (10/27/21) its now 3x2 inches, slightly itchy at times, red sore to the touch and still big hard knot under it. Classified as "covid arm"  it seems to continue getting bigger throughout the day and each day after. Slighly nauseous now and then.
Approximately 6 hours after flu shot was administered (shot was not administered at the address listed above, it was done as part of the "Shoo the Flu" program), I began to feel lightheaded, my heart felt like it was racing, and I found myself unable to get a good breath. I have had asthma for most of my life, but this felt nothing like an asthma attack.  My wife took me to the ER, where they determined that I had some kind of reaction to the shot, since EKG, electrolytes, heart beat, pulse, and blood pressure were all normal. I was given an IV drip with Benadryl and the symptoms disappeared. No further symptoms emerged later.
Chills, fever 102, swelling of vaccinations its (right arm), increasing pain and redness over next 2 days. Redness and pain spread down arm.
extreme pain in the elbow joint; extreme pain; part of the injected arm with increased pain when trying to grip and pick up objects; increased pain when trying to grip and pick up objects/ability to pick up objects has been impaired due to level of pain; This is a spontaneous report from a non-contactable consumer (patient). An adult female patient received BNT162B2 (Pfizer-BioNTech COVID-19 vaccine, lot number: PPSZER C-1a EN6205, expiry date unknown), via an unspecified route of administration, administered in the left arm on 03Mar2021 at 10:30, dose 1 single for COVID-19 immunization. The patient did not have any medical history. The patient's concomitant medications were not reported. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Prior to vaccination the patient was not diagnosed with COVID-19. Since the vaccination, the patient has not been tested for COVID-19. On Mar2021 (reported as 2 days after the injection), the patient experienced extreme pain in the elbow joint and lower part of the injected arm with increased pain when trying to grip and pick up objects. It's been over 3 weeks since the vaccine and the pain has gotten worse and the ability to pick up objects has been impaired due to level of pain. The events resulted in a doctor or other healthcare professional office/clinic visit. The patient received treatment (unspecified) for the events. The outcome of the events was not recovered  No follow-up attempts are possible. No further information is expected.
Dizziness, Headache, body aches Narrative:  Other Relevant History:
Started with a mild sore throat. By evening, sore throat had worsened and was accompanied by headache and stuffy nose. By the next morning, sore throat was still present, along with alternately stuffy and runny nose, mild dry cough, post nasal drip, and tender sinus. Most symptoms are occurring on the side of the body where the vaccine was administered (left arm, left side of throat, left sinus, left nasal passage).
Pt recv vax on 1/27/99; on 1/28/99 pt exp cough, fever (103-104), listless, unresponsive; dx=sore throat & ear infection; tx=antibiotic
My Period began a week early, and has continued for 5 weeks. It still had not stopped.
Painful swollen lymph nodes under injection side arm; Hives/rash; Hives/rash; Sore arm; This is a spontaneous report from a non-contactable consumer (patient). A 14-years-old male patient received bnt162b2 (BNT162B2), dose 1 via an unspecified route of administration, administered in Arm Right on 14Aug2021 17:00 at age of 14-years-old (Lot Number: FD8448) as DOSE 1, SINGLE for covid-19 immunisation. The patient medical history was not reported. Concomitant medications included ibuprofen; paracetamol (TYLENOL).  The patient experienced Painful swollen lymph nodes under injection side arm, hives, rash, sore arm on 16Aug2021 05:00 with outcome of recovering.  The patient received Benadryl, hydrocortisone cream as treatment.  No follow-up attempts are possible. No further information is expected.
nosebleeds got worse where she was filling up towels with blood; sore throat; cough; A solicited report was received from a 61-year-old female patient, who who received Moderna's COVID-19 vaccine (mRNA-1273) developed significant nosebleeds where she was filling up towels full of blood, sore throat and coughing during and after her Tyvaso session.   The patient's medical history included Secondary Pulmonary Arterial Hypertension. Products known to have been used by the patient within two weeks prior to the event was Sildenafil Citrate. Additional suspected products included Treprostinil Sodium, Plavix, and Aspirin.  On an unknown date, the patient received one of two planned doses of mRNA-1273 (Lot: unknown) for prophylaxis of COVID-19 infection.  On an unknown date, after receiving the vaccine, the patient experienced worsening of nosebleeds filling up towels full of blood, sore throat and coughing. Treatment for the events, nosebleed, sore throat and cough was not reported.   Action taken with second dose of mRNA-1273 in response to the events was not reported.  The event, worsening of nosebleeds filling up towels full of blood was considered not resolved and outcome of the events, sore throat and cough was not reported.; Reporter's Comments: This case concerns a 61 year old female patient with medical history of Secondary Pulmonary Arterial Hypertension, who experienced a serious unexpected event of Epistaxis and NS events of oropharyngeal pain and cough. The events occurred on an unknown date after first dose of the study medication administration.  A causal relationship cannot be excluded. Noting the subject's underlying medical condition and concomitant medication could remain a confounder.
redness at injection site; swelling to the size of a 50 cent piece to injection site; Injection site pain; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE PAIN (Injection site pain), VACCINATION SITE ERYTHEMA (redness at injection site) and VACCINATION SITE SWELLING (swelling to the size of a 50 cent piece to injection site) in a 76-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 011L20A) for COVID-19 vaccination.     The patient's past medical history included No adverse event (No medical history reported.).    On 04-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 15-Jan-2021, the patient experienced VACCINATION SITE PAIN (Injection site pain). On an unknown date, the patient experienced VACCINATION SITE ERYTHEMA (redness at injection site) and VACCINATION SITE SWELLING (swelling to the size of a 50 cent piece to injection site). At the time of the report, VACCINATION SITE PAIN (Injection site pain) had not resolved and VACCINATION SITE ERYTHEMA (redness at injection site) and VACCINATION SITE SWELLING (swelling to the size of a 50 cent piece to injection site) outcome was unknown. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No concomitant medications reported by investigator o No treatment medications provided by the reporter.    This case was linked to MOD-2021-008838 (E2B Linked Report).; 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. MOD-2021-008838:Same reporter
Headache; Sore arm; Chills; Body aches; This spontaneous case was reported by a consumer and describes the occurrence of HEADACHE (Headache), PAIN IN EXTREMITY (Sore arm), CHILLS (Chills) and PAIN (Body aches) in a 58-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 030A21A) for COVID-19 vaccination.     Concurrent medical conditions included Diabetic and Heart disorder. Concomitant products included GLIPIZIDE, Metoprolol SUCCER, FUROSEMIDE, ALLOPURINOL, SIMVASTATIN, LISINOPRIL, DIGOXIN and METFORMIN HCL for an unknown indication.    On 18-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 18-Mar-2021, the patient experienced HEADACHE (Headache), PAIN IN EXTREMITY (Sore arm), CHILLS (Chills) and PAIN (Body aches). The patient was treated with NAPROXEN SODIUM (ALEVE) at an unspecified dose and frequency. At the time of the report, HEADACHE (Headache), PAIN IN EXTREMITY (Sore arm) and CHILLS (Chills) outcome was unknown and PAIN (Body aches) had not resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.
Covid monitoring documentation. PT admitted 12/12/22 documented to have positive covid. PT received Pfizer 1/6/21 Lot EL0140 for dose 1. Dose 2 was Pfizer given on 08/16/21 Lot FC3181.
This spontaneous report was received from a registered nurse and refers to a patient of unknown age and gender. Pertinent medical history or drug allergies/drug reactions were not reported. On 26-MAR-2015, the patient was vaccinated with an improperly stored dose of VARIVAX (Merck) (dose, route, lot number and expiration date were not provided). Concomitant medication was not provided. No adverse effect was reported. No product quality complaint (PQC) was involved. This is one of nine reports from the same reporter. Additional information has been requested.
Diagnosed  with PMR/GCA 6 days after injection, 4 hospitalizations and prostate surgery 2 months after injection. Now taking Glipizide,Tamsulsine,Prednisone, Gabapentin  D3, Magnesium. In addition to Metformin and Lisinopril which were the only meds taken before injection.
I was diagnosed by my dermatologist with the shingles at 48 (no prior history).
Day 2 after second vaccine I had mild arm pain.  Day 3 after second vaccine I awoke around midnight from strong stomach pain.  The pain increased in intensity over the next few hours, then was accompanied by vomiting, every half hour or so.  By early morning, the pain was excruciating, and I was writhing and gasping and vomiting.  I could not hold down any food or water.  The pain was throughout my abdominal area, mostly my stomach.  This extreme level of pain lasted two full days, with it starting to ease the middle of day 3. I was able to drink water and eat crackers late day 3, and felt much better day 4.  Some of the most intense pain I've ever felt in my life.
Pt states initial mild erythema at site after injection - resolved 1-2 days 1/5/21 8 days later noted erythema, swelling pain warmth at site. 10 cm x 10 cm advised to use topical ice, take 25mg oral Benadryl. 1/6/21 swelling resolved erythema spreading - referred to PCP
This spontaneous report was received from a pharmacist and refers to a patient of unknown age and gender. The patient's medical history, concurrent conditions and concomitant therapies were not reported. On 02-MAR-2017, the patient was vaccinated with an expired dose of ZOSTAVAX subcutaneously (lot # L046293, expiration date: 17-FEB-2017; dose was not provided). No adverse effects were reported. Additional information has been requested.
Pt. states that after receiving the 2nd dose of Phizer 08/29/2021, started experiencing symptoms 09/19/2021 of CRVO (left eye), injections of Avastin steroid x2 treatments (Current 11/04/2021). Small amount of improvement currently, recommendations of Follow-Up every 5 weeks for treatment.
Information has been received from a physician via medical records concerning a 16 week old female with no known drug allergies, a gastrointestinal reflux disease, and a history of congenital genital malformation female, colic, left nasolacrimal duct stenosis, mild gynecomastia, mild jaundice and sudden screaming (all events reported in WAES # 0704USA06160) who on 11-JAN-2008 was vaccinated with a first dose of PEDVAXHIB (lot # 656518/0258U) in the left thigh.  Concomitant therapy also given on 11-JAN-2008 included a first dose of ROTATEQ (lot # 657292/0551U);  a first dose of PEDIARIX (lot # AC21B129AA) in the right thigh; and a first dose of PREVNAR (lot # B54016SD) in the left thigh.  Other concomitant therapy included ZANTAC and TYLENOL.  On 05-MAR-2008, the patient was seen in the physician's office for a fever of 102.9 degrees for 24 hours, occasional cough, nasal congestion, and green nasal discharge.  Her temperature in the office was 99.9 degrees rectally.  Lungs were clear to auscultation.  Diagnosis was influenza.  The patient was prescribed TAMIFLU 60/5  1/2 teaspoon bid for 5 days. On an unspecified date, the patient recovered.  Additional information is not expected.
Patient contacted pharmacy on 9/15/21 stating he has been experiencing discomfort in his left shoulder for the last 3 days. There was a language barrier, so he was having difficulty describing exactly what he was feeling. He complained of his shoulder "not feeling right". He was advised to consult with his physician for follow up
Child c/o headache, itchy rash on belly & buttocks, swollen mouth & face, red eyes & fever 102.7.  Mother denies any SOB and child was not taken to the doctor or hospital.  Mother gave her Ibuprofen and Sx were resolved by next morning.
Fell asleep on way home & slept about 30 min; Woke up had difficulty breathing; Taken to ER & placed on O2 tent. P/several hrs O2 level came up.
Injection site and arm hurt for 3 days following Tdap vaccine.  Then stopped for 2 days and now is hurting so bad patient is unable to sleep at night.