chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Treatment of COVID-19; Treatment of COVID-19; Pfizer, Dose Number: 1, 2, 3, 4 / Moderna, Dose Number: 5; This is a spontaneous report received from a non-contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 66-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 30Mar2021 as dose 1, single (Lot number: ER8733), on 20Apr2021 as dose 2, single (Lot number: EW0170), on 16Nov2021 as dose 3 (booster), single (Lot number: FG3527) and on 06May2022 as dose 4 (booster), single (Lot number: Fm9992) at the age of 64 years for covid-19 immunisation; davesomeran, elasomeran (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)), on 31Oct2022 as dose 5 (booster), single (Lot number: 05202217), in left arm for covid-19 immunisation. The patient's relevant medical history included: "known allergies: penicillin" (unspecified if ongoing); "known allergies: sulfa" (unspecified if ongoing). Concomitant medication(s) included: LEVOTHYROXINE. The following information was reported: INTERCHANGE OF VACCINE PRODUCTS (medically significant) with onset 31Oct2022, outcome "unknown", described as "Pfizer, Dose Number: 1, 2, 3, 4 / Moderna, Dose Number: 5"; VACCINATION FAILURE (medically significant), COVID-19 (medically significant), outcome "not recovered" and all described as "Treatment of COVID-19". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (unspecified date) Postive, notes: COVID 19 Treatment; (09Aug2023) Postive, notes: 09Aug2023 my head cold is worse and I am still testing positive for Covid; (Aug2023) Postive, notes: Still testing positive for Covid. Therapeutic measures were taken as a result of vaccination failure, covid-19 which included Paxlovid from 28Jul2023 to 01Aug2023 (Lot: GG0067).  No follow-up attempts are possible. No further information is expected.
Patient is currently pregnant and her estimated delivery date is 7/17/21. At 1140 BP 98/67, P 98, R 28, O2 97% and pt c/o feeling faint, nurse observed pt as pale and hyperventilating.  At 1145 Np 100/65, P 83, R 20, O2 100% pt states she feels lightheaded. At 1150 BP 98/65, P 82, R 20, O2 99%, pt states she still feels lightheaded. At 1200 BP 107/62, P 84, R 21, O2 98%, pt states she feels "better". At 1210 BP 100/65, P 81, R 20, O2 99%, pt states she is no dizzy. At 1215 BP 103/66, P 85, R 20, O2 99%, pt states she is "feeling good". At 1235 pt was discharged home.
Received tetanus shot 9-14-09. That night had chills, dizziness, shortness of breath and chest tightness. Had fever 101 in am. No caryza, cough, sore throat. Symptoms lasted about 24 hours.
Patient felt like they had a flu; Arm pain; Muscle pain; Joint pain; Headache; Lowgrade fever; This spontaneous case was reported by a consumer and describes the occurrence of INFLUENZA LIKE ILLNESS (Patient felt like they had a flu), VACCINATION SITE PAIN (Arm pain), MYALGIA (Muscle pain), ARTHRALGIA (Joint pain) and HEADACHE (Headache) in a 70-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 043L2OA) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     Concurrent medical conditions included Rheumatoid arthritis and Blood pressure (NOS).    On 27-Jan-2021, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 28-Jan-2021, the patient experienced INFLUENZA LIKE ILLNESS (Patient felt like they had a flu), VACCINATION SITE PAIN (Arm pain), MYALGIA (Muscle pain), ARTHRALGIA (Joint pain), HEADACHE (Headache) and PYREXIA (Lowgrade fever). The patient was treated with IBUPROFEN ongoing since an unknown date for Adverse event, at a dose of UNK dosage form. At the time of the report, INFLUENZA LIKE ILLNESS (Patient felt like they had a flu), VACCINATION SITE PAIN (Arm pain), MYALGIA (Muscle pain), ARTHRALGIA (Joint pain), HEADACHE (Headache) and PYREXIA (Lowgrade fever) was resolving.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Concurrent medical conditions included Rheumatoid arthritis and Blood pressure medicine.
Swollen size of a baseball and red rash, fever for 1st 32 hours, fatigue and achy
Headache, chills, fever, stiff neck, sore throat for 8 plus days. Fever 102-103. Rx. Tylenol, Ibuprofen, minimal effect.
Presents to the ED c/o generalized abd pain (worst in epigastric region), onset last night. Assoc sx include fever (Tmax 103.2 *F at home), chills, and generalized body aches all x 4 days, with 1 episode of diarrhea yesterday. Pt also describes feeling a "pins and needles" sensation on the palms of her hands when in contact with warm water.  COVID 19 positive.  Positive for COVID-19 3 weeks ago via rapid testing.  Will not give steroids as patient is not requiring any oxygen replacement.  Discharge Condition: Stable and Improved.  Will be discharged today to home.
Moderna COVID-19 Vaccine EUA Community Clinic Vaccine administered prior to age 18 (17.5)
Began with sore arm--unable to lift.  By 7:00 PM severe headache.  Went to bed.  Saturday minor pain in chest.  By Sunday night so sever thought I might be having heart attach.  Went to ER that performed EKG, Chest Xray, Cat Scan and blood test and sent me how with Pain Med and Nausea Meds.  Still chest pains when I breath.  Another Doctor appointment tomorrow.  Everything started after the Tetanus/Whooping cough vaccine.
I got two doses of the Pfizer vaccine on April 15th and May 8th of 2021. Since then I have been going through all manner of health issues. I have not had any health issues before then. I had surgery to remove blood clot from my groin (they put a stent inside of me) because the blood was not flowing to my left leg. That leg was without a pulse. I went to the doctor and they sent me immediately to the hospital. That when I had the surgery. I have been having shortness of breath and hiccups ever since... The doctor told me today, March 4, 2022 that they will have to do an endoscopy on March 24th. The hiccups are every day for several months now, they are almost violent.  I have been going through a lot ever since the vthe vaccine. I have been taking clopidogrel (blood thinner) since the surgery.  I also find that my chest tightens up from time to time, which scares me a lot. I have not done the booster because of the changes in my body since the first two shots.  I have been lethargic and do not have the energy I use to have to do my exercises, which caused me to gain weight gradually.   I am concerned that there are things that the medical professionals do not know about the vaccine and how it affects us individually.  I am now thinking that I did the wrong thing by taking this vaccine recommended by the CDC.  How do we resolve this issue?  What should my next step be?  I see a lot of new data coming out about the vaccine that I think we all should have been informed of before taking the vaccine.  I am a Singer and this hiccup thing is causing major problems for me.  I cannot go through an entire song without it interfering, which is causing major problems for me doing a live performance. I can get away with it in the studio because we can always stop and start again, but it poses a major problem for me singing live.
This spontaneous report was received from an office manager and refers to unspecified number of patients of unknown age and gender. No information regarding the patients' pertinent medical history, drug reactions or allergies and concomitant therapies was provided.  On unknown dates reported as "over the past 3 months", the patients were vaccinated with improperly stored doses of PNEUMOVAX 23 lot # M039060, expiration date: 22-MAY-2018 (dose, route and site of administration were not reported). No adverse experience was reported. Administered doses of vaccines experienced the temperature excursion of 47 degrees Fahrenheit to 77 degrees Fahrenheit for 21 hours cumulatively over "3 months," on unspecified dates. Data logger was not involved. There were no previous excursions reported. This is one of several reports received from the same reporter. Additional information has been requested.; Sender's Comments: US-009507513-1703USA014473: US-009507513-1703USA014472: US-009507513-1703USA014471: US-009507513-1703USA014470: US-009507513-1703USA007914:
started with feeling achy about 20 hours after vaccine, then headache and very nauseous with a sore arm, the nausea was off and on for about 28 hours, the achy and yucky feeling lasted about 48 hours, and the headache lasted about 72 hours
Pt recvd vax & 1 day p/vax exp blurred vision, shakiness, pain p/inject & nervous feeling; 1 person lost sensation in one arm; sx subsided p/several hrs;
immed p/vax 9AM pt went into a deep sleep;woke 30min later still in a light sleep;10AM would not take bottle from a babysitter;APAP given 1230PM w/feeding;sitter checked child 2PM appeared fine;3PM pt found expired; poss SIDS & vax therapy;
This is a 48y.o. male with a past medical history significant for heart failure with preserved ejection fraction, asthma, CVA, diabetes type 2, hepatitis A, hypertension, myocardial infarction.  He presents to a local HCF for evaluation of shortness of breath that has been lasting for approximately 1 week.  He also notes occasional abdominal pain with diarrhea over the same timeframe.  He also notes that he fell tonight occurring around 8 PM and is also complaining of back pain.  Patient states that he got up to use the bathroom with the help of his wife and states that he slipped on the tile floor which was wet.  He denies hitting his head and denies any loss of consciousness.  Patient is on aspirin.  Patient states that he is lightheaded with standing.  With regards to the shortness of breath he states that it is primarily exacerbated by exertion.  He states that he has a home nurse that placed him on approximately 4 L increased from his baseline of 3 L.  He states that his home nurse had told him that the Bumex he has been taking recently has not been producing diuresis, she states that they were going to transition him to Bumex shots.  He now states that he has not been taking the Bumex for approximately 1 week.
Tetanus TD on 01/18/2006, 01/19/2006 pain in right legs and neck. 01/20/2006 pain worsened , aching with swelling in left side of neck. 01/21/2006 muscle wasting right LE.
02/03/2010 - Wheezing with cough and dizziness. 02/04/2010 - Dizziness and vomiting with fever, wheezing, cough. 02/05/2010 - deep cough. 02/06/2010 - cough and congestion.
30 minutes post-vaccine she developed irritation to her throat and urticaria generalized. She denies any shortness of breath or wheezes.  Took H2 and the symptoms resolved in 24 hours.   She was not seen in the ER for this   She has not had a major reaction to a vaccine in the past.
I received a flu shot on Thursday. I was sick the next 3 days with flu symptoms. I was very tired, lethargic, and irritable. I just felt more sick than with other previous flu vaccines.
This initial spontaneous report was received on 18-SEP-2018 from a lawyer regarding a case in litigation and refers to a female patient of unknown age. No information was provided regarding medical history, concurrent conditions, or concomitant medications. On or about 27-AUG-2009, the patient was inoculated with ZOSTAVAX at a medical group (considered physician's office) as recommended for routine adult health maintenance for the prevention of shingles (dose, route, and indication not provided). The vaccine did not prevent shingles as intended and the patient subsequently contracted a persistent strain of herpes zoster, also known as shingles and other complications. On or about 07-MAR-2013, the patient was treated by a physician at the same medical group for a blistering vesicular outbreak that was diagnosed as severe herpes zoster. As a direct and proximate result of ZOSTAVAX vaccine, and/or despite receiving ZOSTAVAX for the long-term prevention of shingles, the patient suffered painful injuries and damages and required extensive medical care and treatment. As a direct and proximate result of these malfunctions, the patient suffered painful injuries and damages and required extensive medical care and treatment. As a further proximate result, the patient has suffered and will continue to suffer significant medical expenses, and pain and suffering, and other damages. The outcome of the events was unknown. Causality assessment was related. Additional information has been requested.
Redness around injection site Slight itchiness Warm to touch Occurred 8 days after injection Lasting  at least 3days
Patient reported intramuscular pain at the injection site for 9 days. She also reported intermittent tingling down her arm and pain when she made a fist.
accidentally administered a QUADRACEL vaccination in the thigh; Initial information was received on 13-Oct-2021 regarding an unsolicited valid non-serious case from a other healthcare professional via Media Information (MI) (under reference:00811118).  This case involves a 19-month-old patient of unknown gender who was accidentally administered a DIPHTHERIA-15/TETANUS/5 HYBRID AC PERTUSSIS/IPV (MRC5) VACCINE [QUADRACEL] in the thigh (product administered at inappropriate site).   The patient's medical history, past medical treatment(s), vaccination(s), concomitant medication(s) and family history were not provided.   On 12-Oct-2021, the patient received a dose of 0.5mL suspect DIPHTHERIA-15/TETANUS/5 HYBRID AC PERTUSSIS/IPV (MRC5) VACCINE (once, lot C5851AA, expiry date 25-Mar-2023) via an unknown route in the thigh nos (otherwise not specified) for prophylactic vaccination.  This is a case of actual medication error due to vaccine administered at inappropriate site (same day latency).  it was reported "caller states that the doctor in her practice accidentally administered a QUADRACEL vaccination to a 19 month old patient on 12OCT2021. Caller asked for information on how they should proceed. Caller asked if Medical Information was able to provide her with the name of her Sanofi Sales Representative. Caller asked if she could place the doctor on the call and whether or not the doctor could be provided answers to questions or if it would be read from a pre-written script."   Laboratory data was not reported.  At time of reporting, no adverse event was reported.  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 the 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.
I Woke Up and I Felt Achy All Over, My Eyes Were Watery & Itchy, I Had A Fever Of 101.2, I Felt Awful So I Stayed In Bed All Day. I Took Tylenol & I Noticed My Sinuses Were Feeling Really Stuffy & My Eyes Were Watery. I Kept A Low Grade Fever For The Next Few Days & Then I Started Feeling Sinusey I Was Getting Real Congested & I Had Started To Cough A Lot, I Went To Work Monday & I Was Coughing So Bad I Had To Go Home. I Called My Dr. & He Told Me To Go Home & Get Some Rest. By Monday Night I Was Really Feeling Sick. I Was Told I Should Be Feeling Better By Wednesday But I Was Actually Feeling Worse. I Had No Energy I'm Still Really Congested & I Still Cough Often. I Have An Inhaler Now That I Use When Needed.
Patients were administered a dose of improperly stored vaccine; No adverse symptoms were reported; This spontaneous report was received from a registered nurse regarding multiple unspecified number of patients (age or gender not reported).   Concurrent conditions and medical history were not reported for the unspecified number of patients. Concomitant medication reported was sterile diluent (also reported as DILUENT MRK) (lot # not reported).   On unknown dates, doses of varicella virus vaccine live (Oka/Merck) (VARIVAX)(lot # R017635, expiration date 20-JUN-2020) which was improperly stored in a temperature between 6°F to 14°F (7F)) in a time frame of 1 hour were administered to multiple unspecified patients. It was reported that the call was made due to data logger and no previous temperature excursion occurred.  No adverse symptoms were reported for the unspecified multiple patients.   This case was considered non valid due to lack of patient identifiers.
small aortic aneurysm; This spontaneous case was reported by a patient and describes the occurrence of AORTIC ANEURYSM (small aortic aneurysm) in a male patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     Concurrent medical conditions included Immunocompromised (Patient had a weak immune system.).   In May 2022, the patient received fourth dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient received third 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 and first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient experienced AORTIC ANEURYSM (small aortic aneurysm). At the time of the report, AORTIC ANEURYSM (small aortic aneurysm) outcome was unknown.            No concomitant medication was provided.  It was reported that patient received 2 shots of Moderna COVID-19 Vaccine primary series and 2 updated shots because he had a weak immune system.   Patient mentioned he had a small aortic aneurysm that doctors found after receiving Moderna COVID-19 Vaccines, they mentioned it might be there even before the vaccines, and patient did not know if it was related to the vaccine.  Treatment medication was not provided by the reporter.   Reporter did not allow further contact
got very dizzy and almost fainted; Near fainting; This spontaneous report was received from an office manager referring to a 11-year-old female patient. The patient's concomitant medication, pertinent medical history and drug reactions/allergies were unknown by reporter.    On 08-JAN-2021 (reported as today, also reported as 08-JAN-2020), the patient was vaccinated with hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast) (GARDASIL 9), 0.5 milliliter once, intramuscularly for prophylaxis (strength, lot number and expiration date were not reported).        On 08-JAN-2021 (also reported as 08-JAN-2020), the patient got very dizzy and almost fainted (dizziness and presyncope). The patient had never lost consciousness. They waved an ammonia tab under the patient's nose to prevent the patient from fainting. The reporter stated that it was a very short episode, and the patient went home without any further intervention. The outcome of both events were reported as resolved on the same date.  The causality assessment between hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast) (GARDASIL 9) and both events was not reported.
An open sore developed on the back of my throat 2 days after vaccination. I visited any dentist and she prescribed me dexamethasone. After a week and a half the sore disappeared.
About 30 minutes after administration of HPV vaccine, pt. c/o skin burning all over, nausea, trouble getting a deep breath. B.P. 118/68. Accu-check 76. Rested, H2O, snack. No rash, no noted injection site irritation. Feeling some better but skin burning and arm pain. Instructed could take MOTRIN per M.D. here. She will do that at home. To ER if worsens.
606 doses were given after expiration date; This spontaneous case was reported by a nurse and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (606 doses were given after expiration date) in a 47-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 008C21A) for COVID-19 vaccination.     No Medical History information was reported.    On 01-Nov-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 01-Nov-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (606 doses were given after expiration date). At the time of the report, EXPIRED PRODUCT ADMINISTERED (606 doses were given after expiration date) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No Concomitant product use was reported.  On 26-Oct-2021, the vial was placed in the refrigerator. The vial did not undergo any temperature excursion and the patient had no adverse event.  No treatment information was provided.   This case was linked to MOD-2022-491837 (Patient Link).
Had been sore like normal shots. Wouldn't "work out" by moving arm. Now red, got, extremely sensitive, and causing fever and nausea.
fever; arm pain; feeling bad; This case was reported by a nurse and described the occurrence of fever in a female patient who received Herpes zoster (Shingrix) for prophylaxis.   On an unknown date, the patient received the 1st dose of Shingrix. On an unknown date, unknown after receiving Shingrix, the patient experienced fever, pain in arm and feeling bad. On an unknown date, the outcome of the fever, pain in arm and feeling bad were recovered/resolved.   It was unknown if the reporter considered the fever, pain in arm and feeling bad to be related to Shingrix.  Additional details were reported as follows: The age at vaccination was not reported. The patient experienced arm pain, fever and feeling bad for 3 days. The reporter did not consent to follow up. For tolerance of 2nd dose refer linked case US2020AMR246228.; Sender's Comments:  US-GLAXOSMITHKLINE-US2020AMR246228:same patient
The pt experienced an acute onset of vomiting, followed in 48 hours by diarrhea (yellow watery) with vomiting still occurring. No fever, remaiaining well hydrated.
pt recv vax & pt devel numerous oval shaped plaques w/hive like centers on the trunk;other lesions were present on scalp, neck, legs & face;DPH recommended by MD;varicellaform papules & plaques;
Report side effect.; This spontaneous case was reported by a patient and describes the occurrence of VACCINATION COMPLICATION (Report side effect.) in a patient of an unknown age and gender 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 VACCINATION COMPLICATION (Report side effect.). At the time of the report, VACCINATION COMPLICATION (Report side effect.) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.
Patient was seen today by FNP for swollen red and painful injection site.  She states that her arm has been hurting since 10/20/2022.  She states that she just assumed it was normal injection site pain, but the arm has continued to swell and become reddened.  It has also become very painful. She states that she has also experienced nausea and diarrhea.   She received her vaccine to comply with employment requirements at a pharmacy locally.  After viewing entry in LINKS, there is  not a vaccinator given.
I started itching in one finger then it spread to the rest of my body and developed hives so I went to the ER. They gave me an IV of Steroids, then told me to go to my Internists the next day, and she told me that the hospital did the right thing and to continue on that treatment course. It started to get better within a few weeks.