chrisvoncsefalvay/vaers-outcomes huggingface dataset:
about 12 hours post injections I woke up feeling very nauseous, I had chills, body aches, and a headache. About an hour after that I vomited and experience diarrhea. Returning to bed I had trouble sleeping due to the chills and headache bordering on migraine. Once I did fall asleep I would wake up dripping in sweat and needing to go to the bathroom for more diarrhea. This continued for several hours and several trips to the bathroom. The whole day after my vaccine I was unable to eat food, even the smell made me want to throw up. I was cold and nauseous all day.
Client experience tender to swollen lymph nodes in her neck within about 6 hours of time she received the vaccines. She also experienced extreme fatigue, HA, racing heart.
Started having chest pain 22 April 2021. ER doctor did x-ray and ECG. Primary ordered ultrasound which came back normal, leading to a diagnosis of costochondritis. Prescribed anti-inflammatory, which were unsucessful. Pain still persists November 2021, with or without exertion/exercise.
Just slight soreness and itching next couple of days then fine - around 7/8 th day itching and swelling started - looked like a form of hives - raised redness - took Benadryl at night and slightly better next morming - will repeat tonight.
Patient is a 44 y.o. male patient of MD with a history of CAD, OSA, HTN.   See below for summary by diagnosis.   Discharge Diagnoses:   1. Chest pain             -Echo: Ejection fraction 63%, left atrium mildly enlarged, other cardiac chambers are normal, left ventricular mass index is increased, left ventricular segmental wall motion is normal, normal diastolic function, mild tricuspid valve regurgitation, no pericardial effusion             -Sinus bradycardia at night likely related to underlying obstructive sleep apnea.  We will order a Holter monitor as outpatient.             -CT pulmonary artery study is ordered- negative for PE.             -Cardiology is following- imdur started    2. COVID 19             -.Covid-19 Virus Infection Date of onset of symptoms:  12/30/22 Symptoms present on admission: Cough Date of covid positive test:  12/31/22 Vaccination status:  J&J x2 Imaging:   CXR negative Oxygen requirements on admission:   RA Current oxygen requirements:  RA Medical therapy: Decadron Consultants following:  cardiology Anticipated special isolation end date: 10 days from test      3. Sinus bradycardia             -Avoid calcium channel blocker and beta-blocker.             -Outpatient Holter monitor.  Likely related to obstructive sleep apnea   4. OSA, chronic respiratory failure             -4 L at night.   5. Hypokalemia              -Patient potassium 3.3, 40 mEq provided   6. CAD             -History of with recent heart cath 2/2/2022.  Patient's heart cath was severe 1 vessel CAD of the LAD with nonobstructive RCA disease, successful PCI of the LAD.  To be on aspirin 81 mg indefinitely and Plavix for 1 year.   7. Subclinical hypothyroidism             -Repeat after COVID and is symptomatic start low-dose Synthroid
Initial information received on 14-Sep-2018 regarding an unsolicited valid non-serious case received from other health professional. This case involves a 55 years old male patient who received a 0.5 mL dose of FLUZONE HIGH DOSE lot UJ004AA, expiry date: 30-Mar-2019, via intramuscular route in the left arm on 14-Sep-2018. The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided. It was a case of actual medication error due to inappropriate age at vaccine administration. The patient did not experience any adverse event following the vaccination (no reported symptoms). This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holder's compliance with the requirements set out in Directive 2001/83/EC and Module VI of the Good Pharmacovigilance Practices. The classification as a medical error is in no way intended, nor should it be interpreted or construed as an allegation or claim made by the marketing authorization holder that any third party has contributed to or is to be held liable for the occurrence of this medication error. List of documents held by the sender: none.
I had the vaccine at 4:15 on March 30, 2021. Immediately I felt sharp pain in my arm. Then the Vertigo, which I had since day 7 of the first Moderna Vaccine, became very bad -- I was spinning and dizzy. I also immediately began sneezing, and that got worse over the next two hours, and sneezing, runny nose, sinus pain has not stopped (as I write this it is 2 days and five hours). I began running a fever the evening of May 1: my base line temperature is 96.9 - 97.6; it went up to 102.5. I took two Ibuprofen, some herbal remedies and aromatherapy and a cold towel on my face, and my temperature dropped within an hour to 99. The vertigo is better now, just happens for 30 seconds or so when I turn over, lay down or get up quickly. But my fever keeps going up, and my nose is running, ears feel clogged, and beginning to experience shortness of breath and some minor wheezing and cough. Mouth and sinuses very dry. Also, muscle aches everywhere, and having some trouble walking -- feel very stiff. Also, on March 30th, when I came home that evening, I experienced two strange neurological things: I hallucinated that a light was on -- I wondered why it was dim. Then it went off. When I checked the cord, it had not been plugged in at all: I only imagined it was on. Then, I went to make some tea, boiled water in the electric tea pot and heated something in the microwave. I went to pour the hot water but the tea pot was empty, but hot. I was very confused  -- where did all the water go? A minute or so later, I found a cup of tea with the tea bag and water in it: I had made the tea but blanked out and had no recollection of making it. In other words, I lost time and what ever happened in that time. Probably only a minute or two, but very strange. I can be a spacey person, but this was pretty extreme.
This is a spontaneous report from a contactable physician via a Pfizer sales representative. A male patient of an unspecified age (age is either 16 or 17; unit unspecified) received TRUMENBA, via an unspecified route of administration, the first dose was in Dec2018 and the second dose was in Feb2019 at a single dose in the left arm for immunisation. The patient's medical history and concomitant medications were not reported. It was reported that the both times the patient was administered meningococcal group b rlp2086 in his left arm, he had pain in his left side from his jaw to his groin. The patient's mother was not upset about it and he will still get his third dose. Information on the lot/batch number has been requested.
pt recvd vax 7JUN93 exp raised, red, very warm swelling of approx 8cm x 11cm; mom instructed in use of ice therapy & APAP;
About 11:00 pm, upon going to bed, I felt a slight touch of nausea.  About 2 hours later, I woke up with significant nausea and walked through the house, hoping it would subside.  It stayed with me and felt I had to have a bowel movement, which turned out to be diarrhea.  I felt a bit better, but the nausea persisted at the level where I felt sitting would be better than laying in bed.  So I sat in a recliner for a couple of hours until the nausea was minimal and then went to bed.  Upon awakening, I felt 90% better with a slight touch of nausea, though my left arm was still quite sore, making it difficult to lift.  Near the day's end, I felt well once again, except for a sore arm, which took another day or so to feel good.
COVID 19 Treatment; COVID 19 Treatment; This is a spontaneous report received from a contactable reporter(s) (Other HCP) from product quality group. The reporter is the patient.  A 42-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 07Jan2021 as dose 2, single (Lot number: Ek4176) and on 11Oct2021 as dose 3 (booster), single (Lot number: Ff2590) at the age of 41 years, in left arm for covid-19 immunisation; coviD-19 vaccine (COVID-19 VACCINE), as dose 1, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history was not reported. Concomitant medication(s) included: BUSPIRONE; FLUOXETINE. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant), outcome "unknown" and all described as "COVID 19 Treatment". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: Unknown results, notes: Treatment of COVID-19. Therapeutic measures were taken as a result of drug ineffective, covid-19.  Clinical course: No known allergies. Patient received other medication in two weeks. Paxlovid for treatment of COVID-19, started on 02Jul2022 and stopped on 07Jul2022. On 10Jul2022, she experienced the event Rebound infection. No treatment given.   No follow-up attempts are possible. No further information is expected.; Sender's Comments: Based on the information in the case report, a possible causal relationship between reported events and suspect drug BNT162B2 cannot be excluded
Fever; Achy; Did not eat anything much, was not hungry; This spontaneous case was reported by a consumer and describes the occurrence of PYREXIA (Fever), PAIN (Achy) and DECREASED APPETITE (Did not eat anything much, was not hungry) in a 63-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 001B21A) for COVID-19 vaccination.     The patient's past medical history included COVID-19. Concomitant products included VITAMINS NOS and PAROXETINE for an unknown indication.   On 11-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 11-Mar-2021, the patient experienced PYREXIA (Fever), PAIN (Achy) and DECREASED APPETITE (Did not eat anything much, was not hungry). At the time of the report, PYREXIA (Fever), PAIN (Achy) and DECREASED APPETITE (Did not eat anything much, was not hungry) had resolved. Not Provided    The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.   The events started 10 to 12 hours after receiving the first dose and lasted for four days. The patient states that it felt like she had COVID-19 again. She was wondering if she should take the second dose. The events were treated with Tylenol.
fatigue; Nausea; Headache; chills; This is a spontaneous report from a contactable other health care professional (HCP) reporting for herself. A 64-year-old not pregnant female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) Lot number: EK9231, Intramuscular on right arm on 05Jan2021 at single dose for COVID-19 immunization. Medical history included Covid-19 and allergy to penicillin. Concomitant medications were not provided. Patient did not receive other vaccine in four weeks. On 05Jan2021 patient experienced nausea, headache, chills, fatigue. She was not treated for the events. Patient had not been tested for COVID-19 post vaccination. Patient was recovering from the events, at the time of the report.
pt recv vax 15JUN97 & 29JUN97 pt exp chickenpox w/fluid-filled vesicles on hands;presented to MD;pt recovered;
Pt in chair for injection. Upon completion, pt noted to have head slightly tilted to right side and eyes staring straight ahead. No verbal response to questioning. Eyes moved toward direction of voice but did not appear to recognize speaker and returned to looking straight ahead at wall. Remained seated and unresponsive approx 30 seconds. Pale and diaphoretic upon regaining responsiveness. Unaware of "blanking out". States he remembers feeling "warm and dizzy" (room also warm). Cool compresses applied, kept seated about 5-10 minutes and fanned. Observed about 3 hours later and next day. Other than "sore arm", no other complaints, signs, symptoms.
Developed shortness of breath and high blood pressure within 48 hours.  Chest pain and back pain.  Shortness of breath when working out slightly.
Agitated, sleepiness, and forceful vomiting. Baby could not keep anything in his stomach for 6 hours without vomiting immediately. Baby was staring blankly and not responsive for two short periods on 1/30. Baby had a fever of over 101, treated with Tylenol. As of 1/31/14 baby now experiencing increased agitation, prolonged crying, and insomnia.
Severe swelling at injection site (football size); fever; severe pain radiating down to the groin; pain lasted 3-4 days.
injection site arm pain; sever chills; a fever for 15 hrs peak at 101.7F; This is a spontaneous report from a contactable consumer (Patient). A 44-years-old male patient received bnt162b2 (BNT162B2, Pfizer-BioNTech Covid-19 mRNA Vaccine, Solution for injection, Batch/Lot number EL3247), dose 2 via an unspecified route of administration, administered in Arm Left on 10Feb2021 09:30 as DOSE 2, SINGLE for covid-19 immunisation (Age at vaccination 44 Years) at Workplace clinic. Medical history included drug hypersensitivity. The patient's concomitant medications were not reported. The patient previously took doxycycline and penicillin and experienced drug hypersensitivity, bnt162b2 for covid-19 immunization (Lot number EL3247, 20Jan2021Administration time9:15 AM Vaccine location Left arm). Other medical history none. No other vaccines within 4 weeks prior to the COVID vaccine. Prior to vaccination, patient was not diagnosed with COVID-19. Since the vaccination, patient has not been tested for COVID-19. On 10Feb2021 23:30 patient experienced injection site arm pain, sever chills, a fever for 15 hrs peak at 101.7f. The patient underwent lab tests which included body temperature: 101.7 fahrenheit on 2021 a fever for 15 hrs peak at 101.7F. Therapeutic measures were taken as a result of all events includes Tylenol and Advil for pain and fever. The outcome of all events was recovered on an unspecified date in 2021.  Follow-up attempts are completed. No further information is expected.
Systemic: Allergic: Difficulty Breathing-Medium, Systemic: Allergic: Difficulty Swallowing, Throat Tightness-Medium, Systemic: Flushed / Sweating-Medium, Additional Details: Metallic taste in mouth
Extreme dizziness and numbness in mouth and teeth within 1 hour of shot.  These symptoms went away for a day but have since returned.
Information regarding Prevnar (pneumococcal 7-valent conjugate vaccine (diptheria crm197 protein) injection) was received from a consumer regarding a 10-month-old female patient who experienced erythema multiforme. At 10 months of age, the patient received the third dose on 23-OCT-2003. Medical History: The patient previously experienced diarrhea while taking Prevnar. Product Details: Indication for Prevnar was immunization. Product was administered on 23-OCT-2003. Dose regimen was 1 dose 1 time per day (intramuscular). Concomitant Therapy: Patient was not taking concomitant therapy. Event Details: The patient developed a fever of 103 deg. F on the evening of 23-Oct-2003. On 24-Oct-2003, she developed a rash that spread over the next several days. On 27-Oct-2003, she was seen by a physician because the fever of 103 deg. F persisted and the rash has spread over the whole body except from the knees down. The patient's mother stated that the rash was diagnosed as erythema multiforme (erythema multiforme); however, the mother indicated that the physician did not consider it to be related to multiforme); however, the mother indicated that the physician did not consider it to be related to Prevnar. As of 28-Oct-2003, fever persisted and the rash had spread over the whole body including eyes, ears, and mouth. Related case(s): The patient experienced diarrhea following receipt of her first two doses of Prevnar (see MCN HQWYE671131OCT03 and HQWYE671231OCT03). No additional information was available at the date of this report.
Something kicked in like drinking espresso; Everything, all senses seemed like they were amplified/Blues bluer, reds redder, sense of smell enhanced, sense of hearing enhanced.; Seemed like had more energy; This is a spontaneous report from a contactable consumer (patient) reported for himself. A 62-year-old-male patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Lot Number: ER8731) administered in left arm on 13Apr2021 09:15 at age of 62-year-old at single dose for COVID-19 immunization. Medical history was not reported. Prior vaccinations: the only one caller can really think of is when caller was 8 or 9 years old, received the DPT vaccine and had rash and fever of 102. Caller cannot provide NDC/lot/expiration. Caller states he has a Vaccination card for all the vaccines received in the last 15-20 years. The last vaccine caller received was the second dose for shingles in Jul2020. There were no prior vaccinations within 4 weeks. There were no additional vaccines administered on same date of the Pfizer suspect. Concomitant medications were not reported. Caller is a consumer reporting he received the first dose of the Pfizer Covid 19 Vaccine took first dose vaccine yesterday, 13Apr2021 at 0915. Reports this is crazy, he hears a lot of people talking about negative effects, caller had the weirdest side effects that are still going on. Caller states all the symptoms began about two hours after receiving the first dose Pfizer Covid 19 Vaccine. Caller received the first dose Pfizer Covid 19 Vaccine at 0915 and on 13Apr2021 at 1115 something kicked in, like drinking espresso. On 13Apr2021, everything, all senses seemed like they were amplified. Blues bluer, reds redder, sense of smell enhanced, sense of hearing enhanced. Everything amplified, everything kicked into overdrive. It was like caller did not have to drink coffee today. Reports it was a good feeling, it was an awakening. It was just like the whole body seems like its amplified. On 13Apr2021, seemed like had more energy, everything, almost like drinking two doses of espresso coffee, enhanced all senses and everything. Caller states it was like the wildest thing ever experienced with a vaccine. Everybody else is talking about negative side effects and mine is like drinking high potency coffee, energy level spiked up. Caller did not know if the Pfizer Covid 19 Vaccine amped up his immune system or whatever. States he has never had any real problems before. The adverse events did not require a visit to Emergency room or Physician office.  Non-serious. Outcome of events was not recovered.   No follow-up attempts are needed. No further information is expected.
Caller refused additional AE; An expired dose of MMR II was administered to a patient.; This spontaneous report was received from a registered nurse referring to a patient of unspecified age and gender whose medical history, concurrent conditions, previous adverse drug reaction, or family adverse drug reactions were not provided.  On 19-APR-2022, the patient was vaccinated with an expired dose of measles, mumps, and rubella (wistar ra 27-3) virus vaccine, live recombinant human albumin (rha) (M-M-R II) subcutaneous injection, for prophylaxis (dose, route of administration, anatomical location, and vaccine scheme were not provided; lot number T012806 was determined to be a valid lot number, expiration date reported and established as 14-APR-2022).  There were refused additional adverse events (AE) (no adverse event). It was reported that no temperature excursion on the vaccine was made.
This spontaneous report as received from a certified medical assistant refers to an unknown number of patients of unknown ages and gender. On an unknown dates the patients were vaccinated with a dose of COMVAX (lot #, expiration, dose, route unspecified), stored as high as 53F and as low as 26F for unknown periods of time. No adverse effect was reported. Attempts are being made to obtain additional identifying information to distinguish the individual patients mentioned in this report. Additional information will be provided if available. This is one of several reports from the same source. Additional information has been requested.
Upper arm where PENTACEL given was swollen, tense, hot, erythema, red line approximately 11 x 11 cm around. Almost cleared by 4 days.
received the 2nd dose of the Moderna COVID19 vaccine 22 days after the 1st dose; This spontaneous case was reported by a pharmacist and describes the occurrence of INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (received the 2nd dose of the Moderna COVID19 vaccine 22 days after the 1st dose) in a  patient of an unknown age and gender who received mRNA-1273 (Spikevax) for COVID-19 vaccination.     No Medical History information was reported.   On an unknown date, the patient received second dose of mRNA-1273 (Spikevax) (unknown route) 1 dosage form. On an unknown date, received first dose of mRNA-1273 (Spikevax) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient experienced INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (received the 2nd dose of the Moderna COVID19 vaccine 22 days after the 1st dose). At the time of the report, INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (received the 2nd dose of the Moderna COVID19 vaccine 22 days after the 1st dose) outcome was unknown.        For mRNA-1273 (Spikevax) (Unknown), the reporter did not provide any causality assessments.   No concomitant medication were provided.  Reporter did not information on the event at the time of the report.  No treatment medication were provided.
Patient was administered SMALLPOX vaccine during 1st trimester. Currently in 2nd trimester after learning of pregnancy.
ActHIB Expired dose was administered/No AE; Initial information received on 28-Oct-2019 regarding an unsolicited valid non-serious case received from a nurse.  This case involves a 2 months old female patient who received expired dose of vaccine HIB (PRP/T) VACCINE [ACT-HIB].  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.  Concomitant medications included POLIO VACCINE INACT 3V (VERO) (IPOL POLIO VACCINE).  On 28-Oct-2019, the patient received first 0.5 mL dose of suspect HIB (PRP/T) VACCINE lot UI904AAA (Frequency = once) expiry date- 19-SEP-2019 via intramuscular route in the left thigh.  It was a case of actual medication error due to Expired vaccine used.  At the time of report 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 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.
Sunday started with severe headache and continued with mild body aches and feeling of just being tired but didn't change my day much. Woke Monday morning at 4am to get ready for the work and the room was spinning. Off and on for the next 4 or so hours my blood pressure dropped and I had to lay back down. Even laying down had the room spinning. It has not been consistent and has improved as the day has gone but has yet to go away.