chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Information has been received from a registered nurse concerning a 23 year old female with a history of papilloma viral infection and abnormal pap test (NOV-2007), with no known allergies, and no concomitant medications, who on 05-MAY-2008 was vaccinated with the first dose of GARDASIL, 0.5 ml, IM to the right deltoid, (Lot# 0152X).  That same evening when the patient arrived home she had a rash on both arms, on her trunk, and descending down to her thighs.  The patient telephoned the office and was treated with over the counter Benadryl, she recovered on an unspecified date.  No product quality complaint was involved.  Additional information has been requested.
This spontaneous report as received from a Medical Assistant refers to a 12 years old female patient who was not pregnant. The patient was vaccinated with first dose of GARDASIL (lot number, route not reported) on an unspecified date approximately 2 months ago in August 2012. No other co-suspects were reported. No concomitant medications were reported. During questioning preparatory to administration of the second dose in the series, the patient mentioned that she experienced a metallic taste in her mouth just after being injection with the vaccine. The patient had sought medical attention via office visit. No treatment was given. No laboratory diagnostics studies were performed. The patient reported that the metallic taste spontaneously resolved at an unspecified time. Additional information has been requested.
Received expired vaccine on 05Jan2022; This spontaneous case was reported by a health care professional and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Received expired vaccine on 05Jan2022) in a 64-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 068H21A) for COVID-19 vaccination.     No Medical History information was reported.    On 05-Jan-2022, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) .25 milliliter. On 05-Jan-2022, the patient experienced EXPIRED PRODUCT ADMINISTERED (Received expired vaccine on 05Jan2022). On 05-Jan-2022, EXPIRED PRODUCT ADMINISTERED (Received expired vaccine on 05Jan2022) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   No concomitant medications were provided.  No treatment medications were provided.
Pt. presented to office 3 days after vaccine. Large swollen area, warm to touch. Has "improved" since initial reaction. (R) deltoid -> site of PNEUMOVAX.
This spontaneous report as received from a physician refers to a female patient of unknown age. On an unknown date the patient was vaccinated with GARDASIL (dose, route and lot number were not reported). Concomitant medications were not reported. On an unknown date the patient experienced hot flashes and nausea. The outcome of hot flashes and nausea was not reported. The relationship between the GARDASIL and the events was not reported. Patient sought medical attention: contacted with the office. Additional information has been requested.
This spontaneous report was received from a 54 year old male patient. No medical history, drug reactions or allergies. On an unknown date (approximately February 2013), the patient was vaccinated with live ZOSTAVAX (left arm injection) (lot#, dose and route not reported). There was no concomitant therapy. On 01-FEB-2012, where the vaccine was given itches and it was red and hurts when it gets touched. No treatment was given. The patient did not seek medical attention. The relatedness of the event with live ZOSTAVAX was not provided. Additional information is not expected.
Information has been received from a lawyer regarding a case in litigation concerning a male patient (age unknown). The patient's medical history, concurrent conditions and concomitant medication use were not provided. In 2008, the patient was vaccinated with ZOSTAVAX, (lot# and route unknown) for routine adult health maintenance for the prevention of shingles. 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 26-SEP-2016, the patient was treated by a physician for a blistering vesicular outbreak, that was diagnosed as severe herpes zoster, or shingles. The patient was prescribed VALTREX for management of his painful symptoms and chronic pain. As a direct and proximate result of the ZOSTAVAX vaccine, and/or despite receiving ZOSTAVAX, for 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. Additional information has been requested.
, Additional Details: pt states large area of redness refused to come to store to show pharmacist pt states area seemed hot to touch tender and swollen
Presents at clinic: adverse reaction to vaccine L arm c/o pain - hot to touch, pain c mobility, erythema below deltoid-->elbow, tense swelling noted, "hard to touch."  Benadryl given.  Prednisone started.  No previous reactions to vaccines.  Improvement noted 1/26/2005
Patient is fully vaccinated and boosted 1/17/2022.  A 48-year-old male patient presented secondary to chest pressure. Positive for cough.  He states he started feeling after being diagnosed with COVID on last Tuesday.  The patient otherwise denies any fevers, chills, nausea, vomiting or diarrhea, CXR: no acute process. Negative troponins.  Negative D-dimer. Discharged home.
16 hours post vaccine #2 had fever of 102, headache, fatigue, body aches and chills. Ibuprofen 600 mg taken at 20 hours post vaccine.  Improvement notified and fever decreased.  At 26 hours post vaccine headache notified and fever of 99.6. Tylenol 500 mg taken.    Today (1/13) 2 days past vaccine heart rate has been in 100s -110s all day. Headache notified.  At 48 hours post vaccine fever developed of 100.5, aches, headache.  Tylenol 650mg taken
COVID 19 Treatment; COVID 19 Treatment; This is a spontaneous report received from a contactable reporter (consumer). The reporter is the patient. A 56-year-old male patient received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), on 28Oct2022 as dose 5 (booster), single (lot number unknown) at the age of 56 years, in right arm for covid-19 immunisation; BNT162b2 (PFIZER BIONTECH COVID-19 VACCINE), on 01May2022 as dose 4 (booster), single (lot number unknown), in right arm for covid-19 immunisation; covid-19 vaccine as dose 1, single (lot number unknown), as dose 2, single (lot number unknown) and as dose 3 (booster), single (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) and COVID-19 (medically significant) both with onset Dec2022, outcome "unknown" and described as "COVID 19 Treatment". Therapeutic measures were taken as a result of drug ineffective and covid-19 which included Paxlovid taken from 23Dec2022 to 28Dec2022.  The information on the batch/lot number for BNT162b2, BNT162b2 omi ba.4-5, BNT162b2 has been requested and will be submitted if and when received.
pt recv vax 7dEC95 & pt devel a breakthrough case of chickenpox;pt devel vesicles & papules on the face, chest, arms;sx were resolving @ the time of the report;
Slight soreness in left arm around and just below the point of injection.  This went away around 6PM on Tuesday, the day after the injection.  For about 2 hours around 10PM until I went to sleep on Monday night (the night of the injection), I had a slight fever but it was only slight.  I had a more intense fever (though for only 30 minutes) the evening that I had my flu shot last October when I visited my doctor for a check up, so I would definitely categorize the fever from the COVID-19 shot as very slight.  It was gone when I woke up in the morning.  After I woke up, I was a bit nauseous, but it was so slight (and I have not been nauseous for well over a year) that it took me awhile to actually recognize it as being nauseous.  This lasted for 15-20 minutes and then it disappeared.  On Wednesday morning, my heart went into an irregular heartbeat that felt different than what I feel when it goes into an irregular heartbeat.  I have no idea if there is any relation between receiving the vaccine and getting an irregular heartbeat but I thought I should report it.  I have recovered from all symptoms from the vaccination except the irregular heartbeat.  I put down as "unknown" if I have recovered  from the adverse events as I don't know if going into an irregular heartbeat was in any way related to the vaccination.
covid vaccine breakthrough  dose 1 8/14/21 Moderna 006C21A dose 2 9/10/21 Moderna 040B21A
administered 2nd dose to a patient who was underage; This spontaneous case was reported by a nurse and describes the occurrence of PRODUCT ADMINISTERED TO PATIENT OF INAPPROPRIATE AGE (administered 2nd dose to a patient who was underage) in an 18-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 040B21A and 014C21A,) for COVID-19 vaccination.     No Medical History Reported.    On 13-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 12-May-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 12-May-2021, the patient experienced PRODUCT ADMINISTERED TO PATIENT OF INAPPROPRIATE AGE (administered 2nd dose to a patient who was underage). At the time of the report, PRODUCT ADMINISTERED TO PATIENT OF INAPPROPRIATE AGE (administered 2nd dose to a patient who was underage) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) and mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   Treatment information not provided. Concomitant medications were not provided. Symptom text in narrative included Nurse called to report that a patient had been administered the Moderna COVID-19 Vaccine under the age of 18 at the time of her 1st dose. Patient received the 1st dose on 13Apr2021 (LOT: 040B21A Expiry date: 01Jan1900). Patient received the 2nd dose on 12May2021 (LOT: 014C21A, Expiry date: 01Jan1900).The patient did not experience any side effects from the vaccine and is not on any concurrent medication. Nurse only wanted to report the case and did not require any further information. Preferred method of contact is email Consent obtained for safety team to contact for follow-up. No written documentation to be sent to the Nurse.
5:30PM on Saturday 4/10/21 began chills and slight headache.  Arm very sore. 7:00PM  fever was 101, chills and headache worsening  9:00PM fever was 102.1, chills, massive headache and bones of legs hurt.  11:00PM fever was 102.7,  all same symptoms except now whole body hurt and very cold.  4/11/2021 12:00AM fever was 102.9, all same symptoms, started Tylenol  2:00AM fever was 103.1, all same symptoms  4:00AM fever was 102.9, woke up nauseous 5:30AM  fever was 102.7, threw up.  6:00AM  fever was 102.9.  Took more Tylenol  10:00AM fever was 101.1.  Was able to sleep for 4 hours 12:00PM fever was 100.5.   Took Advil (2) for headache.  5:00PM fever was 98.3.  Took more Advil (2)- headache was still pounding.    9:30 PM fever was 101.5.  Chills returned.  Went back to Tylenol.  4/12/2021 1:00AM fever was 98.9.  Chills were gone.  Felt better.  7:00AM fever was 98.3. 9:30AM Feeling foggy.  Left work to come back home.   9:45AM fever was 99.5.  Took Tylenol.  Head still hurting but manageable.  11:00AM fever was 101.1.  Headache returning.  1:00PM fever was 100.9.  Same general weakness.   3:00 PM fever was 101.4.  Took Tylenol.  6:00 PM fever was 99.5.    9:00 PM fever was 99.0 11:00 PM fever was  98.2 4/13/2021 Slept through the night.  Stopped taking medicine.  8:30AM fever was 98.6  11:00AM fever was 98.8 As of right now, I feel better outside of just general weakness from previous fever.  At injection site is still extremely sore and today has developed to look a bit infected.  It is itchy and sore to touch.
Purpose: Sores in mouth and nose. Eye swollen, sores on nose and mouth jaw pain, headache and swollen glands after COVID-19 vaccine
While administering Pfizer vaccines, the Director of Nursing asked me to draw one dose of Moderna for a patient. This person was discharged but called to return for the second Moderna vaccine dose. She stated that the patient was in a wheelchair and she would send the patient right in. So, I began drawing the Moderna dose. The DON walked out of the office and a patient in a wheelchair entered right away and stated he was here for a shot. Thinking this was the patient sent by the DON, I administered the Moderna Vaccine as I still had the syringe in my hand. After giving the dose I checked system and found the patient was not yet registered. I then went to find the DON to add the patient into the system. When she returned to the office, she stated this was not the patient she had sent.  Upon review of Pts. record, it was found that he had been previously vaccinated on 1/31/2021 and 2/21/2021 with the Pfizer vaccine. Pts. physician and family have been notified and he is being monitored.  He has not experienced any adverse effects to date.  Monitoring is ongoing and notification will be forthcoming should it occur.
On the Fifteenth of November 2021 immediately after the dose I had a two inch red mark or whelp and my arm was quite painful and my entire shoulder was in pain as well and the pain has never really went away like something is wrong  in my should this condition has progressed to the point where I can no longer raise my shoulder .My doctor will order an MRI on my next visit and I am currently taking PT as well.
I started experiencing swelling of my lip and eye lids and tear duct areas. I also starting having itching all over body with small red rashes/hives  that predominantly happened on my scalp, sides and groin area. This all started in late November 2021. The day after receiving my booster shot on 12/2/2021, I had another lip/eye swelling episode and an intense rash all over my body. This has been ongoing since and for the last 2 weeks approximately, the rashes have been severe and occurring daily. Antihistamines help. I have been taking Benadryl daily. The hives are itchy and get worse if I scratch. The hive breakouts seem most severe at night. Lip swelling is random and usually happens in the morning. The intensity does seem to be lessening over the last couple days, but it is hard to say if it is getting better and if it  will continue to improve as this has been elusive and hard to track until I connected it to the vaccines.
Hospitalized 12/29/2021; COVID-19 positive 12/29/2021; fully vaccinated   BRIEF OVERVIEW: Discharge Provider:  MD Primary Care Provider: , MD Admission Date: 12/29/2021 Discharge Date: Jan 6, 2022 DETAILS OF HOSPITAL STAY: PRESENTING PROBLEM: Hypoxia  Generalized weakness  COVID-19    HOSPITAL COURSE: Patient is an 81-year-old man with history of coronary artery disease, CABG, pulmonary embolism, atrial fibrillation, seizure, type 2 diabetes, diastolic congestive heart failure.  Patient presents to the hospital secondary to weakness.  He is identified to have COVID-19.  He had a similar hospitalization in November with weakness requiring a subacute rehab stay, and he did improve following that rehabilitation stint.   In the emergency department he is found to have hypotension, he received 2 L of fluids, he was also noted to have O2 saturations of 88% requiring 2 L of oxygen.  COVID-19 PCR tested positive.  Chest x-ray revealed moderate pulmonary vascular congestion and suspicious alveolar edema versus superimposed pneumonia.  He was admitted to the general medicine service for further workup and management. Patient was suspected to have COVID-19 pneumonia with acute hypoxemic respiratory failure, with possible superimposed pulmonary edema.  He was placed on dexamethasone 6 mg daily.  He completed 5 days of remdesivir.  His CRP normalized and his D-dimer was negative.  His acute hypoxemic respiratory failure resolved, and was doing well on room air. In regards to his chronic heart failure with preserved ejection fraction, it did not seem that he was decompensated on presentation.  His weight was stable from his last cardiology appointment.  He was resumed on torsemide, and weight decreased to 93.5 kg.  Torsemide was adjusted to attempt to avoid over-diuresis.  Patient did tolerate this well, and his discharge weight is 94.2 kg and discharge torsemide dose is 30 mg. He was noted to have some resting bradycardia, his metoprolol XL was decreased to 75 mg daily. Patient was seen in consultation with PT and OT, and subacute rehabilitation was recommended. Discharge was delayed due to transportation issues on 1/5 with plans for discharge today at 1/6. No issues overnight. Patient continues to remain in stable condition on room air with no abnormal vitals signs. Patient is comfortable with plan for discharge to facility.
pt was given 0.2ml of adult Pfizer covid 19 vaccine rather than the Pediatric Pfizer   no problems reported
Patient developed an itchy rash that looked like goose bumps a few hours after getting HPV # 1. She was not ill and the rash was gone in 4-5 days.
Swelling to upper ridge of top lip, irritation to outer upper gum, and numbness to tip of tongue and itching.  I took Benadryl to help control symptoms.
Patient stated that they had quite a bit of pain in his shoulder, had some bruising that spread down his arm, and what looked like red blood vessels visible on his right shoulder. He had no pain for the first injection. This occurred about a month ago, but the patient is still experiencing intermittent pain/soreness on and off.
Patient is 15 years and 1 month. And was given a shot for age 16 and above.
Myalgia, Fever, fatigue Narrative: missed work following second dose due to above symptoms
Patient said he lost muscle control later the same day and lost bladder control temporarily. "Felt bad".
The pt experienced a hive like rash that occurred 15 minutes post vax. The pt's mother said this happens quite frequently which apparently is related to fruit etc. He had a fruit drink approximately 2 hours prior to administration.
Some of the Pfizer vaccine leaked from the syringe when needle retracted from the patient's arm.
Within 48 hrs, pt. developed widespread hives all over body (trunk, arms, legs). Did not report any difficulty breathing. She was advised by MD to take OTC ZYRTEC daily until hives clear.
Swollen, red and itchy arm. It began two days after the shot. Then resolved. Then came back worse on the 20th, 11 days post shot.
This spontaneous report as received from a Licensed Practical Nurse refers to a patient of unknown age. On 25-JUN-2013 the patient was vaccinated with GARDASIL (lot # H012973, expired date 05-MAR-2015), route, dose, and frequency unspecified. The GARDASIL was improperly stored at 8.5 degrees C. -9.1 degrees C for 720 hours. There was no adverse effect reported. The outcome of the patient was unknown. This one of several reports received from the same source. Additional information has been requested.
Went form what doctors described as runners Blood Pressure and heart rate, to persistent high blood pressure.
I have been having big red circle on my arm and its swollen and it's painful; Red mark is spreading, its getting bigger and bigger; I have been having big red circle on my arm and its swollen and it's painful; I have been having big red circle on my arm and its swollen and it's painful; like starting to get itchy; This is a spontaneous report from a contactable consumer (patient). An unknown age and gender patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Batch/lot number and Expiration date Unknown) on 23Dec2020 at single dose for covid-19 immunization. Medical history and concomitant drug were not reported. Patient stated had the COVID vaccine on Wednesday and within the past few days, had been having big red circle on arm and its swollen and it's painful, patient was not able to lift arm and unleash having pain, it's like starting to get itchy and arm is swollen. The red mark was spreading, it was getting bigger and bigger, it's been 2 days drew circle on it last night and this morning you can already see the red color out of the circle. Outcome of the event was unknown.  Information on the lot/batch number has been requested.
left arm was freezing cold/hand went cold; hands and feet were numb; tingling throughout both arms and legs; chest pain; This is a spontaneous report from a contactable consumer. A 47-years-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Batch/Lot Number: EL8982, Expiration date was not reported), dose 1 via an unspecified route of administration, administered in Arm Left on 29Jan2021 13:00(at the age of 47 years) as dose 1, single for covid-19 immunisation.  Medical history included sulfa allergy, penicillin allergy. Concomitant medications included letrozole (LETROZOLE). Patient was not pregnant at the time of vaccination. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. The patient did not receive any other vaccines within four weeks prior to the vaccination. On 31Jan2021 the patient experienced left arm was freezing cold her hand went cold, hands and feet were numb, tingling throughout both arms and legs, she had chest pain.  The action taken in response to the event(s) for bnt162b2 was not applicable. Patient visited emergency room for occurred events. Patient did not receive any treatments. The outcome of events was recovering.  Follow-up attempts are completed. No further information is expected.
Had shot at 2:30 Pm,  Sitting in my truck and about 2:35 i started getting a warm feeling in my legs and feet (waist down) (Felt like same feeling when getting a CT scan when getting the dye put in veins,)  Lasted about 25 minutes . then stated to feel it wear off.  tired next day but dont know if from vaccine.  (did not go to doctor)
12-8-03 Sent home from school. Rash- discrete red dry lesions, itching on ABD and arms. No further eruptions, temp. or malaise.
arm is still hurting and he has limited movement with it; arm is still hurting and he has limited movement with it; This is a spontaneous report from a contactable consumer (patient). A male patient of an unspecified age received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration on 01Apr2021 (Batch/Lot number was not reported) as dose number unknown, single for COVID-19 immunization. Medical history and concomitant medications were not reported. The patient got the Pfizer COVID-19 vaccine on 01Apr2021 and stated that his arm was still hurting and he had limited movement with it. He states that it is not hurting on the outside of the arm where they gave the shot but deep inside. He states that they must of done something to his arm like hit a nerve or something. He stated that he had been calling and told them about his issue but they keep telling him to call back in two weeks, and referred him to a physical therapist. He stated that he called a gentleman at the university and the gentleman stated he did not need physical therapy. Caller stated that no one in his family will get the shot because of what had happened with his arm. He stated he had called several 800 numbers but he kept getting the run around. Caller wanted to know if the vaccine was suppose to be given at a certain angle and a certain temperature and what Pfizer can suggest to get rid of the pain. The outcome of events was not recovered.   Information on the Lot/Batch number has been requested.