chrisvoncsefalvay/vaers-outcomes huggingface dataset:
RHEUMATOID ARTHRITIS; This spontaneous report received from a patient via a social media through company representative concerned a patient of unspecified age, sex, race and ethnicity. The patient's weight, height, and medical history were not reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin and batch number were not reported, and expiry: Unknown) dose, start therapy date were not reported, 1 total, dose 1 (first shot) administered for covid-19 prophylaxis. The batch number was not reported. Per procedure, no follow-up will be requested for this case. No concomitant medications were reported. On an unspecified date following vaccination with first shot of covid-19 vaccine ad26.cov2.s, the patient experienced rheumatoid arthritis. It was reported as "1st shot put me into rheumatoid arthritis and I've been in a living hell and I reported and it did t do anything you dont give a care about any of us and our side effects". The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of rheumatoid arthritis was not reported. This report was serious (Other Medically Important Condition).; Sender's Comments: V0: 20221252714-rheumatoid arthritis. Insufficient information is available to make a causality assessment. Therefore, this event is considered unclassifiable.
Swollen and redness at injection site. Fever of 100. Chills. Diarrhea. Fatigue. Headache. Symptoms got better the second day but still malaise persisting.
Fever, malaise cough, congestion and chest tightness started with 36 hours. Two days of extreme fatigue, napping and unable to perform usual daily activities (shower, cooking, self-care) and in bed for most of days 2-4 after receiving vaccine. Arm was sore for about 2 weeks. Fatigue continued to limit activities, required additional sleep and naps for 1 month following vaccine. Cough, chest tightness for 6 weeks. Felt sick and poor energy until 9/20. Cough continues but no mucous since 9/20. First month post vaccine had negative impact on my work performance, alertness and home activities which was clearly related to my mandated vaccine as a healthcare provider.
Mild migraine headache; Mild migraine headache; Weeks later it returned and been coming with much more strength and aura; This is a spontaneous report from a contactable consumer, the patient. A 74-year-old non-pregnant female patient received the second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EN6201) via an unspecified route of administration in the left arm on 21Feb2021 at 08:00 (at the age of 74-year-old) as a single dose for COVID-19 immunisation. Medical history included migraine (years ago, the patient used to have migraines but haven't had them in many years), degenerative disc disease of the spine, nerve block, high blood pressure (BP), and cholesterol. The patient had no known allergies to medications, food, or other products. Prior to the vaccination, the patient was not diagnosed with COVID-19. The patient did not receive any other vaccine within four weeks prior to the COVID vaccine. Concomitant medications included losartan (MANUFACTURER UNKNOWN), topiramate (MANUFACTURER UNKNOWN), famotidine (MANUFACTURER UNKNOWN), and loratadine (MANUFACTURER UNKNOWN); all from unknown dates for unknown indications. The patient previously received the first dose (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EL9269) via an unspecified route of administration in the left arm on 31Jan2021 at 08:00 (at the age of 74-year-old) as a single dose for COVID-19 immunisation. On 21Feb2021 at 16:00, the afternoon of the second COVID shot, the patient experienced a mild migraine headache. It appeared only when standing and sitting but went away when the patient laid down. It happened the next day also and a few days later, it came back. On an unknown date in 2021, weeks later it had returned and had been coming with much more strength, aura and nausea. The patient reported that the COVID vaccine had triggered migraines again and the patient hoped that would go away. Each time it was getting worse. The events did not result in doctor or other healthcare professional office/clinic, emergency room/department, or urgent care. Since the vaccination, the patient had been tested for COVID-19. On 08Apr2021, the patient underwent a nasal swab test and the result was negative. Therapeutic measures were not taken as a result of the events. The clinical outcome of events mild migraine headache and weeks later it returned and been coming with much more strength and aura was not recovered at the time of the report.  No follow-up attempts are needed. No further information is expected.
Nausea in the morning, then around 3:30pm had right shoulder, rib and lower back pain. Thirty minutes later could hardly breathe had to call ambulance, was taken to emergency room hospital. Had xray, blood drawn, it showed I had pneumonia. Was sent home to take pain pill (Norco) and Antibiotic (Azithromycin 250). Follow up with Doctor October 15, took another xray and Doctor sent me back to hospital-emergency room- I had right side lower lobe pneumonia and I had right side pleural effusion/empyema was admitted to hospital and had a chest tube put in October 17, was in hospital for 10 days to drain liquid.
This spontaneous report as received from a medical assistant refers to a patient of unknown age and gender. There was no information about the patient's concurrent conditions, concomitant therapies, pertinent medical history, drug reactions or allergies provided. On 30-JUL-2018, the patient was vaccinated with the first dose of VAQTA injection, lot # R006346, expiration date 31-JAN-2021 (also reported as 21-APR-2019), (dose and route of administration were not provided) for prophylaxis. On 13-SEP-2018, the patient was vaccinated with the second dose of VAQTA injection, lot # R002487, expiration date 21-APR-2019 (dose and route of administration were not provided) for prophylaxis. No adverse event was reported.
Patient stated that severe itch ensued after both vaccines were administered and has not resolved in 5 days. Counseled mom and patient on antihistamine usage and to consult MD for further evaluation if that does not help.
feeling all the secondary symptoms; inappropriate age at vaccination; This case was reported by a consumer and described the occurrence of adverse event in a 37-year-old patient who received Herpes zoster (Shingrix) for prophylaxis.   On 15th August 2019, the patient received Shingrix. On 15th August 2019, unknown after receiving Shingrix, the patient experienced inappropriate age at vaccine administration. On 16th August 2019, the patient experienced adverse event. On an unknown date, the outcome of the adverse event was not recovered/not resolved and the outcome of the inappropriate age at vaccine administration was unknown.   It was unknown if the reporter considered the adverse event to be related to Shingrix.  Additional information received were as follows: The day before the reporting date, the patient received Shingrix at 37 years of age, which led to inappropriate age at vaccine administration. The patient experienced feeling all the secondary systems. The patient asked how could improve this and how long did it take to be gone.
Myalgia, NauseaVomiting, chills low grade temp 99.9 Narrative:
Fever 101.4 x 2 days 7/19/02 and 7/20/02, coughing, congestion, runny nose. Went to see MD in office on 7/20/02. Diagnosed as having viral infection and treated with Albuterol and breathing treatments x 1 week and amoxicillin po x 1 week. Mom called health dept 9/5/02. Rec'd call 9/5/02-she called back 9/9/02 mom states child completely recovered.
8:00 AM on May 7, 2021 woke up with sore throat, head and body aches, and runny nose 6:51 PM had a fever of 99.9 degrees F May 8, 2021 still exhibiting same symptoms as the previous day  3:30 PM had a fever of 100.5 degrees F
while administering a Flublok vaccine dripped down the patient arm, not have tightened the needle enough/No AE; while administering a Flublok vaccine dripped down the patient arm, not have tightened the needle enough/No AE; while administering a Flublok vaccine dripped down the patient arm, not have tightened the needle enough/No AE; Initial information received on 15-Oct-2019 and additional information received on 17-Oct-2019 regarding an unsolicited valid non-serious case received from a pharmacist.  This case involves a male patient in his 60s who while administering a 0.5 ml dose of INFLUENZA QUADRIVALENT RECOMBINANT VACCINE [FLUBLOK QIV] prefilled syringe vaccine dripped down the patient arm lot number and expiry date not reported via intramuscular route in the right arm on 14-Oct-2019.  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.  Concomitant medications included VARICELLA ZOSTER VACCINE RGE (CHO) (SHINGRIX).  It was an actual medication error due to Wrong technique in product usage process.  It was a case of vaccine underdose and exposure via skin contact.  No adverse event reported.  This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holders compliance with the requirements set out in Directive 2001/83/EC and Module VI of the Good Pharmacovigilance Practices. The classification as a medical error is in no way intended, nor should it be interpreted or construed as an allegation or claim made by the marketing authorization holder that any third party has contributed to or is to be held liable for the occurrence of this medication error.  Information on the batch number was requested.
atrial fibrillation; chest pain; headache; vertigo; This case was reported by a consumer via call center representative and described the occurrence of atrial fibrillation in a 59-year-old male patient who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included Shingrix (received 1st dose on 5th March 2019 and did not note any side effects).   On 25th June 2019, the patient received the 2nd dose of Shingrix. On 26th June 2019, 1 days after receiving Shingrix, the patient experienced headache and vertigo. On 5th July 2019, the patient experienced atrial fibrillation (serious criteria hospitalization and GSK medically significant) and chest pain (serious criteria hospitalization). On an unknown date, the outcome of the atrial fibrillation, chest pain, headache and vertigo were recovered/resolved.   It was unknown if the reporter considered the atrial fibrillation, chest pain, headache and vertigo to be related to Shingrix.  Additional details were provided as follows: The patient received dose 2 of Shingrix and the next day he experienced headache and vertigo, and events have resolved.   The patient reported that on 5th July 2019, he was experiencing chest pain.   The patient was admitted to the hospital and on 7th July 2019 a diagnosis of atrial fibrillation was made.   The patient was in the hospital for 2 nights and discharged.  He wore a heart monitor which was described as a wireless remote device for two weeks after discharge.  The monitor was read by the physician and there was nothing remarkable. The reporter consented to follow up. Emergency room visit required.
This is a solicited report from a Pfizer sponsored program via Regulatory Authority based on information received by Pfizer from the Regulatory Authority, MFR Control No. 21K-163-4077901-00.   A contactable 58-year-old female consumer (patient) reported that she received BNT162B2 (PFIZER BIONTECH COVID-19 VACCINE) the first dose on 22Jan2021 as single dose via intramuscular route and second dose on 12Feb2021 as single dose via intramuscular route for COVID-19 immunization at the age of 57-years-old. The patient's medical history included Crohn's disease. Concomitant medication included ADALIMUMAB (HUMIRA, Solution for injection in pre-filled pen via subcutaneous for moderate to severe adult Crohn's disease. In Jul2021 the patient experienced COVID-19. The outcome of the event was reported as recovered. It was unknown if patient was enrolled in a COVID-19 Vaccine Trial.   The lot number for the vaccine, BNT162B2, was not provided and will be requested during follow up.  The reporter's assessment of the causal relationship of the events with the suspect product was not provided at the time of this report. Since no determination has been received, the case is managed based on the company causality assessment.; Sender's Comments: Based on the information available and close temporal association, a possible contributory role of the suspect BNT162B2 cannot be excluded for the reported events . The case will be reassessed once new information is available
This spontaneous report as received from a other health professional refers to a patient of unknown age. On an unknown date the patient was vaccinated with PROQUAD lot # N008824 for prophylaxis. Concomitant therapies included sterile diluent. On an unknown date the patient experienced incorrect product storage and no adverse event. The outcome of incorrect product storage and no adverse event was unknown. The reporter considered incorrect product storage and no adverse event to be not related to PROQUAD. Sender's Comments: US-009507513-1708USA004667.
death 16JAN95-not attributed to vaccine; death certificate states pt exp multisystem organ failures & acute viral infection
This patient had 2nd Hepatitis B on 07/20/2001. On 07/23/01, he started itching and began noticing blister like skin eruptions, (arms, wrist, ankle, body & legs). He had a similar but milder event after 1st Hepatitis B shot but didn't connect to shot until same symptoms developed following the second shot. No other signs and symptoms.
Complete flare of Postural orthostatic tachycardia syndrome; Complete flare of Postural orthostatic tachycardia syndrome; Can't stand up, walk, talk without struggling to breath; Can't stand up, walk, talk without struggling to breath; Can't stand up, walk, talk without struggling to breath; This is a spontaneous report from a contactable nurse (patient herself). A 44-year-old non-pregnant female patient received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Formulation: Solution for injection, Lot number: ER8733, Expiration date: Unknown), via an unspecified route of administration in left arm on 25Mar2021 at 14:00 (at the age of 44-year-old) as a single dose for COVID-19 immunisation. The patient's medical history included just POTS (postural orthostatic tachycardia syndrome) from 2 1/2 years prior. Concomitant medication included nadolol received in two weeks. The patient previously took cefepime and experienced known allergies: Cefepime. The patient did not receive other vaccines in four weeks. The patient was not diagnosed with COVID priori vaccination. The patient did not undergo COVID test post vaccination. The patient experienced complete flare of postural orthostatic tachycardia syndrome (last flare was 2 1/2 years prior), can't stand up, walk, talk without struggling to breath on 25Mar2021 at 16:30. The events were considered as serious (disability or permanent damage) by nurse. No treatment medications were received for the adverse events. The outcome of the events was not recovered.; Sender's Comments: Based on the current available information and the reportedly close drug-event temporal association, a possible contributory role of the suspect product BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) to the development of the events cannot be excluded. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to Regulatory Authorities, Ethics Committees and Investigators, as appropriate.
trouble breathing; This spontaneous case was reported by a consumer and describes the occurrence of DYSPNOEA (trouble breathing) 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 dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced DYSPNOEA (trouble breathing). At the time of the report, DYSPNOEA (trouble breathing) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No relevant concomitant medications were reported.  No treatment information was provided.  Company Comment: Very limited information regarding this event has been provided at this time. Further information has been requested.; Sender's Comments: Very limited information regarding this event has been provided at this time. Further information has been requested.
Site: Bruising at Injection Site-Mild, Site: Redness at Injection Site-Mild, Systemic: Lymph Node Swelling-Mild, Additional Details: Swelling of lymphnodes under armpit, same arm as injection site.
Hyperesthesia of front surface of left shin (below the knee); Darting pain; This is a spontaneous report from a contactable consumer (patient). A 52-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection), dose 2 via an unspecified route of administration, administered in Arm Right on 11May2021 14:00 (Batch/Lot number: 0183) (at the age of 52 years) as 2ND DOSE, 0.3 ML SINGLE DOSE for COVID-19 immunisation. The patient medical history was not reported. There were no known allergies. There were no other medications in two weeks. Patient was not pregnant at time of vaccination. Patient previously received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection), dose 1 via an unspecified route of administration, administered in left arm on 20Apr2021 (Batch/Lot number: WE 0161) (at the age of 52 years) as 1ST DOSE, 0.3 ML SINGLE DOSE for COVID-19 immunisation. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient has not been tested for COVID-19. The patient experienced hyperesthesia of front surface of left shin (below the knee) and darting pain, both on 13May2021 with outcome of not recovered. There was no treatment received for the events.  Information on Lot/Batch number was available. Additional information has been requested.
Pt came home from school on 1/29 c/o pain @ injection site.  Pt had swelling, 1" long by 1/2" wide.
Patient said he had a history of fainting/passing  out after stressful medical events.  He received 1st dose of Pfizer vaccine from my intern without incident. He proceed to the waiting room to wait the 30 minutes that was recommended.  After about 5 min. passed, his girlfriend alerted us that he was feeling faint.  I went to check on him and after talking with him for a few minutes, his head rolled back and he lost consciousness for approx 5-10 seconds.  I went into the pharmacy to dial 911. When I got back to him, he was already back awake.  Fire dept was dispatched and they checked his vitals and he signed a form to go AMA to the hospital.
Patient contacted the pharmacy Sunday morning 10/30/2022.  She reported receiving vaccine on wed evening.  Friday at 8pm she had sudden onset of symptoms/side effects...extreme headache, back pain , abdominal pain, fever 101, chills (freezing, shaking), weakness, nausea, general muscle aches, loss of appetite, frequent urination (no dysuria).  As of Sunday, still had back pain, headache, stomach pain, nausea.   Directed her to contact MD, since still having various pains concerning her.
Pt's mother called 6-19-09 reporting redness, swelling and warmth to touch at injection site on right arm. She stated not sure how long, but patient just made her aware.
Patient received x7 vaccines on 9/19/17. Now has upper left arm cellulitis. Pt received Hep A, Hep B, Meningo, Polio, Td/Tdap/Varicella. Please contact Health Clinic for details. Pt is being treated with BACTRIM as of 9/21/2017. That is all the information I have. Thank you.
COVID+7/19.  Admit to hospital with Covid pneumonia  Acute hypoxic respiratory failure
No additional AE reported; the vaccine was administered after expiration; This spontaneous report was received from Healthcare Business Professional (HBP) (also reported as office manager), referring to a patient of  unknown gender. The patient's concurrent conditions, pertinent medical history, drug reactions/allergies, and concomitant medications were not provided.  On 04-MAY-2021,  a patient was vaccinated with a expired dose of Measles, Mumps, and Rubella (Wistar RA 27-3) Virus Vaccine, Live (rha)(M-M-R II) 0.5 milliliter, lot number S013536, expiration date 02-MAY-2021 (dose, strength, scheme of vaccination, route of administration were not reported), as prophylaxis (Expired product administered).   No additional adverse event was reported.
Pt received 3rd dose of Pediarix, Prevnar and also flu and Rotateq on 3/12/07. Pt developed difficulty breathing, shaking and high fever (per parents). 4/20/07 Received ER medical records from hospital which reveal patient experienced fever 103.7, cough, nasal congestion, runny nose, pulling at ears, vomiting x1 post tussive & shivering on 3/13/07 day after vax.  Ear exam was WNL.  D/C to home on antipyrectics. FINAL DX: Fever, likely secondary to immunizations.
From initial information received on 27/Aug/2003 from a health care professional regarding an adverse event occurring in the U.S.A., it was reported that a 14-year old male patient received TD ADS adult, lot number U0844AA, administered intra-muscularly in the left deltoid, and a dose of Hepatitis B vaccine, lot number ENG5384A2, administered intra-muscularly in the right deltoid on 13/Aug/2003. The next day, the patient developed swollen neck nodules and a headache. An MRI of the brain was done, however, no results were provided. The patient's recovery status is unknown.
Fever. Body aches. Nausea. Chills.  Sweats.
Patient was given the first COVID-19 vaccination at approximately 1254 today in her left deltoid. She approached writer at 1310 in no apparent distress. She voiced symptoms that were concerning to her. She indicated about 5 minutes after she received the injection, her tongue felt like it was burning and tingling. She also stated her chest was burning. Denies every having these symptoms ever before.  She currently denied shortness of breath, chest pain, shoulder pain, nausea, or throat swelling. No changes in voice were observed by writer. Last time patient ate was between 0930 and 1000 this am. Patient shared that she was feeling anxious about having the vaccine and wonders if this is the reason why she is having the symptoms. Vitals taken, all within normal range.    Patient encouraged to remain for 30 for observation. No further concerns were verbalized to writer during her stay. Patient was encouraged to call 911 if she develops shortness of breath, chest pain, throat swelling or other concerning symptoms  after she leaves. Patient verbalized understanding and was agreeable with plan.
Pt developed chills, vomiting, headache. No rash at site of injections. Just didn't feel good til Saturday (1/2/10). Recovered fine, otherwise (Both given at same time)