chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Ok well it was a gradual awareness that I was becoming out of breath and low energy. When I went to the gym I started noticing I could only do half the amount of workout that I could before. I also go home and take a nap after my half workout, I'd nap for a few hours. I went to see a homeopathic DR and she said my heart seemed weak and suggested I see a specialist. I used to be very in shape and it is very odd for me to feel so out of it and tired. I go to see the specialist on this Friday July 9th, 2021. I haven't received any treatment but the DR did tell me to cease any cardio workouts or anything until I see the specialist.
Narrative: COVID infection following COVID vaccine series and after previous COVID infection 06/16, Pfizer, dose #1 07/07, Pfizer, dose #2 02/02/22, Pfizer, dose #3 12/27 COVID swab, result: detected 01/03 COVID swab, result: detected 03/17 COVID swab, result: detected 12/23 pt cc: cough, sore throat, constitutional complaints, lingering cough exposure: unknown 01/03 CXR impression: No radiographic evidence of acute cardiopulmonary disease. 01/03 pt admit to ED cc: cough started w sore throat and some constitutional complaints dx: covid Los: 1 day
feels desperate; tired; fatigued; didn't sleep well.; a bit of a headache; felt restless; Pain in arm; This spontaneous case was reported by a health care professional and describes the occurrence of PAIN IN EXTREMITY (Pain in arm), RESTLESSNESS (felt restless), DEPRESSED MOOD (feels desperate), INSOMNIA (didn't sleep well.) and HEADACHE (a bit of a headache) in a 45-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     Concurrent medical conditions included Anxiety. Concomitant products included FENOFIBRATE for Cholesterol, FLUOXETINE HCL and TRAZODONE for an unknown indication.    On 26-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 27-Mar-2021, the patient experienced PAIN IN EXTREMITY (Pain in arm). On 29-Mar-2021, the patient experienced RESTLESSNESS (felt restless), INSOMNIA (didn't sleep well.) and HEADACHE (a bit of a headache). On 30-Mar-2021, the patient experienced DEPRESSED MOOD (feels desperate), FATIGUE (tired) and FATIGUE (fatigued). On 28-Mar-2021, PAIN IN EXTREMITY (Pain in arm) had resolved. At the time of the report, RESTLESSNESS (felt restless), DEPRESSED MOOD (feels desperate), INSOMNIA (didn't sleep well.), HEADACHE (a bit of a headache), FATIGUE (tired) and FATIGUE (fatigued) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.    Treatment details provided include Advil double action: acetaminophen and ibuprofen,echinacea,aswagandha
Fever (101-102 degrees), fatigue, nausea, muscle aches, shivering
Patient states following the flu vaccine, he had the chills, low appetite, felt delirious, weak, and dizzy. He had 2 accidents from not being able to make it to the bathroom in time. He also had fever, headache, and swelling at the injection site. Patient reports that these symptoms have improved significantly. (This info was recorded 10/11/18, the day following vaccination).
My daughter showed flu-like symptoms in the week following a flu shot given on 3/3/2008.  Her symptoms include fever, vomiting, diarrhea, abdominal pain and respiratory congestion.
Rash - BENADRYL Rash X 24 hours:  Started 7 days after antibiotic/vaccine *Rash is worse on Right side (thigh) at injection site where MMR & VARICELLA given
A non-serious spontaneous report of medication error and nose bleed has been received from a consumer concerning a 36-month-old male, subsequent to FLUMIST. This case is submitted in accordance with MedImmune's post-marketing commitment on accelerated reporting for the newly indicated population of 2 years to 54 months of age for FLUMIST. No medical history or concomitant medications were provided. The patient received FLUMIST 0.2 milliliters on 01-Oct-2009, the entire dose was administrated into one nare. Two hours after receiving FLUMIST the child experienced a nose bleed. No outcome was reported for the nose bleed while the vaccination error is considered to be resolved.
Diagnosed with pulmonary hypertension; After two half weeks she started having palpitation; This spontaneous case was reported by a physician (subsequently medically confirmed) and describes the occurrence of PULMONARY HYPERTENSION (Diagnosed with pulmonary hypertension) in a 62-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     The patient's past medical history included No adverse event (No reported medical history).   On 28-Dec-2020, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 25-Jan-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. In February 2021, the patient experienced PULMONARY HYPERTENSION (Diagnosed with pulmonary hypertension) (seriousness criterion medically significant) and PALPITATIONS (After two half weeks she started having palpitation). At the time of the report, PULMONARY HYPERTENSION (Diagnosed with pulmonary hypertension) had not resolved and PALPITATIONS (After two half weeks she started having palpitation) outcome was unknown. Not Provided      For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   Concomitant medication use was unknown.  Treatment information was not provided.  Company comment: Very limited information regarding these events has been provided at this time.  Further information has been requested.; Sender's Comments: Very limited information regarding these events has been provided at this time.  Further information has been requested.
Information has been received from a consumer concerning her 62-year-old husband with high cholesterol and high blood pressure who on 07-MAY-2008 was vaccinated with a dose of zoster vaccine live (Oka/Merck). Concomitant therapy included unspecified cholesterol and blood pressure medications. On 07-MAY-2008, the patient experienced severe headache. The patient did not seek medical attention. At the time of the report the patient's status was not recovered. A product quality complaint was not involved. No further information is available.
x1 blood work attempted- failed then did shots, dizzy light headed, next day very fatigued, rt. arm hurt from injection site to shoulder.
Body aches, headache, skin painful to touch, extreme fatigue. All occurring between  hour 16 -28, post injection.
Pt began shaking; it looked as if he were having a chill; it began about 8:00 pm and continued until apx 9:00 am the following morning; F/U with Dr. day after vaccines; no treatment; EEG performed with test results normal.
gone down but it still itches; arm is still itchy; delayed reaction; itching; rash; started in the same area where I had the shot; reaction to the shot almost 2 weeks later; tingling; arm is swollen; This spontaneous case was reported by a consumer and describes the occurrence of INJECTION SITE REACTION (reaction to the shot almost 2 weeks later), PARAESTHESIA (tingling), PERIPHERAL SWELLING (arm is swollen), PRURITUS (gone down but it still itches) and PRURITUS (arm is still itchy) in a 69-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 007M20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     The patient's past medical history included No adverse event. Concomitant products included VERAPAMIL, METFORMIN, LEVOTHYROXINE SODIUM (LEVOXYL), TRIAMTERENE, PRAVASTATIN, LETROZOLE, IRBESARTAN and APIXABAN (ELIQUIS) for an unknown indication.    On 02-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 11-Feb-2021, the patient experienced INJECTION SITE REACTION (reaction to the shot almost 2 weeks later), PARAESTHESIA (tingling), PERIPHERAL SWELLING (arm is swollen), ADVERSE REACTION (delayed reaction), VACCINATION SITE PRURITUS (itching), RASH (rash) and INJECTION SITE SWELLING (started in the same area where I had the shot). On 19-Feb-2021, the patient experienced PRURITUS (gone down but it still itches) and PRURITUS (arm is still itchy). At the time of the report, INJECTION SITE REACTION (reaction to the shot almost 2 weeks later), PARAESTHESIA (tingling), PERIPHERAL SWELLING (arm is swollen), PRURITUS (gone down but it still itches), PRURITUS (arm is still itchy), ADVERSE REACTION (delayed reaction), VACCINATION SITE PRURITUS (itching), RASH (rash) and INJECTION SITE SWELLING (started in the same area where I had the shot) outcome was unknown.        The action taken with 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.   No treatment medications were reported.
Administering nurse errored by drawing vaccine from adult vile. As such, dosage administered for patent's second vaccine was 50mcg/0.25mL rather than stipulated dose of 25mcg/0.25mL.
Two days after my vaccine I started to get breast pain which is strange because I just had my period 1.5 weeks prior. So it?s like I started PMSing a bit early. I got my period a few days ago which means I had my period twice this month which is very uncommon for me.
Patient received shot and then was sitting in a chair in observation area and passed up for about 1 min. We called 911 and I talked with her after she came to and until paramedics arrived. She was sweating and just felt out of it right away. Pulse and blood pressure were low when paramedics took her vitals. Within 10 minutes of assessment vitals were back normal and they told her she could go home. I called and followed up today and she stated she woke up this morning feeling "normal" and she thinks the episode was related to her hormones and not the vaccine.
This spontaneous report was received from a currently 41 years old female, regarding herself. There were no concomitant medications, concurrent conditions and medical history. In July 1977,  the patient was vaccinated with her first dose of M-M-R II (dose, route, lot#, expiration date and anatomical place of vaccination were not provided), for normal child vaccine. On an unspecified date on July 1977, 24 to 48 hours after receiving the vaccination (when the patient had 17 month old), the patient's ankles and joints swelled and subsequently was diagnosed with Juvenile Rheumatoid Arthritis. Therefore, she received an unspecified treatment and "many" unspecified test were performed, but no results were reported. On an unknown date in 1980, she recovered from juvenile idiopathic arthritis because her Rheumatoid (RA) factor test was negative. On an unknown date (also reported as "now), she got titers pulled and found out she had immunity for measles and rubella but not mump (mumps antibody test negative). At the time of reporting, the outcome of mumps antibody test negative was unknown. Nevertheless, the reporter did not provide a causality assessment between M-M-R II, juvenile idiopathic arthritis and mumps antibody test negative. The reporter considered the events to be serious for the following reasons: disability, life threatening and hospitalization on unspecified dates. Upon internal review, juvenile idiopathic arthritis was determined to be medically significant.
In a retrospective chart review that was conducted in 2 HIV primary care clinics, Patient 5, is an HIV positive patient, at least 18 years of age, with documented history of HBV vaccination administration prior to November 2017, and negative for both HBsAg and anti-HBs after previous HBV-vaccination. Baseline laboratories included HIV RNA undetectable, CD 4 count 95 cells/uL, CD 4 8%, negative for anti-HBc and negative HCV co-infection. On an unspecified date, the patient received and completed both doses of HEPLISAV-B vaccine. On an unspecified date, the patient was noted as not having achieved seroprotection. Company comment: The company assessed the event as non-serious.; Sender's Comments: The company assessed the event as non-serious.
Pt had flu vaccine in left deltoid 10/29/02. She reports that the next day she began to have some swelling and redness of the arm. She is here today for assessment. There is redness, about a 3x3in. circle toward the inner aspect of the left arm just above the elbow along with a little swelling and slight tenderness. The redness is below where the shot was given. Advised her that this can happen sometimes and that she needs to apply a cool compress as needed and take Tylenol q 4-5 hrs. Inst. to let us know if this does not improve.
This spontaneous report as received from a Registered Nurse refers to a 41 year old female patient with inappropriate dose of MMR II and RECOMBIVAX. On 17-JULY-2014, the patient was vaccinated with M-M-R II and RECOMBIVAX. On 23-JULY-2014, the patient inadvertently received another dose of RECOMBIVAX and M-M-R II.  No adverse effects were reported. No further information was provided. The outcome of extra dose of RECOMBIVAX and M-M-R II is unknown. Additional information is not expected.
the patient experienced pain in his arm; subsequently experienced a swollen injection site, from the deltoid past the elbow; subsequently experienced a swollen injection site, from the deltoid past the elbow; This spontaneous report was received from a pharmacy student referring to a 68 year old male patient. The patient's pertinent medical history and concomitant medications were not reported. The patient had not drug reactions/allergies.       On 21-JUL-2019, the patient was vaccinated with the second dose of pneumococcal vaccine, polyvalent (23-valent)(PNEUMOVAX23) intramuscularly in his upper arm (not specified), lot # R025297 with expiration date 08-JUN-2020, for prophylaxis.     On 22-JUL-2019, the patient experienced swollen injection site (injection site swelling), from the deltoid past the elbow (peripheral swelling). Additionally, the patient experienced pain in his arm (pain in extremity). No laboratory diagnostics tests were performed to the patient. It was unknown if the patient received treatment for the events. At the time of reporting, the outcome of the events was reported as not recovered.      The causality assessment between the events and pneumococcal vaccine, polyvalent (23-valent)(PNEUMOVAX23) was not provided.
I didn't felt so well; This is a spontaneous report received from a non-contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A female patient received BNT162b2 (BNT162B2), as dose number unknown, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: MALAISE (non-serious), outcome "unknown", described as "I didn't felt so well".  Additional information: It made her think about the effects of the omicron booster since the last shot she got. She didn't felt so well and she did not want to feel sick again in this hard times of her life.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Patient c/o pain at site of injection (R deltoid area) noted to have slight induration and had problem elevating the (R) shoulder above level of shoulder. Over 12 hours later, swelling, and induration had decreased substantially with ROM of (R) shoulder improved. Patient c/o slight pain at site of injection-MOTRIN for pain with (+) effect.
Sore bicep like a muscle pull. Then swelling fever, redness from the top of the bicep to the left elbow similar to an intense sunburn if driving in the summer with window up and arm exposed, itchiness, awakening with sweat.
Injection site pain, redness at injection site, then followed by chills and fever. Injection site swelling about 2" with fever and redness at injection site - lasted about 5 days. Also was feeling unwell, tiredness & muscle pain for a few days.
Information has been received from a consumer concerning her now 5 month old son who in approximately December 2008, "when he was 2 months of age", was vaccinated with a dose of PEDVAXHIB. The mother reported that the patient received "an unknown HIB vaccine". The manufacturer of the HIB vaccine was unknown. Concomitant therapy included PREVNAR. In approximately December 2008, "for 4 days after vaccination", the patient was extremely lethargic. On an unspecified date, the patient recovered from lethargic. The patient was seen by the doctor and sought unspecified medical attention. Additional information has been requested.
Information has been received from a physician and a consumer concerning her male baby, who in February 2008, was exposed through his mother to a dose of GARDASIL (lot number 659435/1265U) administered on 26-OCT-2007. Concomitant medication included (ORTHO TRI-CYCLEN). On 13-NOV-2008 the patient was born with a weight of 5 pounds/7 ounces and had anemia at birth. The infant was born with only one kidney and duodenal atresia which were considered congenital anomalies. In follow-up, the patient's mother mentioned that her "boy was born with a bunch of birth defects". The patient's outcome was unknown at the time of reporting. The mother's experiences were captured in WAES# 0812USA01616. The infant's experience was previously reported in WAES 0812USA01616. No further information is available.
On Friday, I awoke with itches spots on my right elbow and left knee.  I applied Gold Bond lotion and it was helpful:
I know at least 3 people that got COVID even having the vaccine; Based on the current case data, this case has been classified as invalid. This spontaneous case was reported by a consumer and describes the occurrence of COVID-19 (I know at least 3 people that got COVID even having the vaccine) in a  patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. unknown) for COVID-19 vaccination.     No specified medical history has been 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 COVID-19 (I know at least 3 people that got COVID even having the vaccine). At the time of the report, COVID-19 (I know at least 3 people that got COVID even having the vaccine) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       Concomitant medications were not provided. Treatment information was not provided.
Got the shot and still get shingles/suspected vaccination failure; Shingles; Very painful; systems got very bad; This serious case was reported by a consumer via interactive digital media and described the occurrence of vaccination failure in a patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   On an unknown date, the patient received Shingles vaccine. On an unknown date, an unknown time after receiving Shingles vaccine, the patient experienced vaccination failure (Verbatim: Got the shot and still get shingles/suspected vaccination failure) (serious criteria GSK medically significant), shingles (Verbatim: Shingles), pain (Verbatim: Very painful) and feeling bad (Verbatim: systems got very bad). The outcome of the vaccination failure was unknown and the outcome of the shingles, pain and feeling bad were not reported.   It was unknown if the reporter considered the vaccination failure, shingles, pain and feeling bad to be related to Shingles vaccine.     It was unknown if the company considered the vaccination failure, shingles, pain and feeling bad to be related to Shingles vaccine.   Additional Information: GSK Receipt Date: 12-MAR-2023 This case was reported by a patient via interactive digital media. The patient reported that he/she received Shingles vaccine and still experienced shingles. The patient stated that yes it was very painful and all her/his systems are got very bad. This case was considered as suspected vaccination failure as details regarding completion of primary schedule, time to onset for shingles and laboratory confirmation regarding shingles were unknown at the time of reporting. Follow-up would not possible as no contact details were available.
Swollen arm, red rash from my left shoulder to my elbow, fever and chills, hives on my face, nausea.
Patient  developed episode of diarrhea shortly after 1st shot in series,  this was followed by  lower extremity swelling and mild dyspnea on exertion, that quickly exacerbated after the 2nd shot on 5/15/2021,  that resulted in severe dyspnea on exertion, severe lower extremity swelling with approximately 25 lb weight gain, orthopnea and hemoptysis. Patient reported temperatures of 99.2 F to 99.8 F.   Outside CT chest abdomen pelvis angiogram showed moderate to large acute segmental/subsegmental pulmonary emboli with trace right heart strain and right lower lobe pulmonary infarction, moderate right pleural effusion, acute splenic vein thrombosis with extension to the proximal portal vein and associated splenic infarcts, bilateral renal infarcts, and evidence of portal hypertension. He was transferred to the Hospital for further management. Upon presentation here he was tachycardic but with stable blood pressures and requiring up to 5 L by nasal cannula. Initial laboratory studies were notable for WBC 21.0, INR 1.8, D-dimer 11653, NT pro-BNP 17684, troponins 603 to 579 to 574, CRP 127. He was started on a heparin infusion. He was admitted to the MICU for further management.   Bedside ultrasound demonstrated reduced biventricular contractility. He was given two doses of 40 mg intravenous furosemide with about 3.5 L of urine output since admission (net negative 3.1 L). His oxygen was weaned to 1 L by nasal cannula. Lower extremity venous and arterial Dopplers were negative.  Subsequent imaging  demonstrated a transperineal inferior infarct with akinesis of the inferior septum, inferior and inferior lateral walls with apical and mid ventricle akinesis secondary to a complete occluded RCA.  moderate pericardial effusion without tamponade noted.  Upper extremity ultrasound demonstrated acute DVT in the lower right IJ, innominate, subclavian and proximal axillary veins.  MRI  venogram was negative for clots, but multiple acute and subacute enhancing infarcts within all 3 vasculature distributions consistent with embolic etiology were noted.  TTE showed of mural thrombus along the septal and inferior walls of the LV apex,  severely enlarged left ventricle with EF of 20%, severe hypokinesis.    Patient was aggressively IV diuresis, with improvement in respiratory status.  Maintained on  high-intensity heparin for pulmonary emboli, DVT, and diffuse arterial and venous thrombosis.  He was bridged to warfarin.  Patient was  prescribed LifeVest for primary prevention. Started on beta-blocker and ACE-inhibitor given EF.     Patient planning on discharge 6/5-6/07, outcome pending.
Information has been received from a physician concerning a teenage female who within the last two years (approximately 2007) was vaccinated IM with a dose of GARDASIL (route in the series and lot number unspecified). The physician reported that the patient "fainted" after getting the vaccine. The outcome of patient was recovered. The patient sought unspecified medical attention. 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 two reports from the same source. Additional information has been requested.
I passed out and had convulsions while sitting in a chair at a nail salon. During this event I peed myself. Prior to the event I had some minor body aches, but no fever. Following the event I returned home and began running a fever of 100.5.