chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Client received her second dose of the Pfizer COVID-19 vaccine (Lot #EW0179 Exp. 8/2021) at 10:03 AM. EMT saw client stand in observation area. Client appeared "unsteady on her feet". EMT rushed to patient and guided her slowly to the ground while protecting her head. Patient then fainted. EMTs assisted patient to gravity bed where patient regained consciousness. Patient was alert and oriented to person, place, time, and event (AAO x 4) immediately following the incident. Client's vitals were assessed every 5 minutes. They were recorded as follows 10:19- Blood Pressure (BP) 100/74, Heart Rate (HR) 86, Oxygen Saturation (SPO2) 99%, and Respiratory Rate (RR) 18; 10:24- BP 100/72, HR 81, SPO2 99% RR 18; 10:29- BP 100/76, HR 82, SPO2 99% RR 16; 10:34- BP 102/74, HR 84, SPO2 99% RR 18; 10:39- BP 100/72, HR 82, SPO2 99% RR 18; 10:44- BP 110/76, HR 86, SPO2 99% RR 18. Client was given a bottle of water and instructed to remain in a semi-fowler's (45 degree) position until vitals stabilized. Patient remained on vaccination site for 30 minutes following the episode of fainting. EMT obtained orthostatic vital signs (vital trend from lying down, to sitting, to standing). Patient was negative for orthostatic hypotension. Symptoms resolved as indicated above in vital signs. Patient stated she was "feeling better" and declined EMS transport. Patient and father were educated by RN on home care (rest and fluids) and to seek emergency medical attention if symptoms persisted or worsened. Patient left the vaccination site at 10:45 with father and sister with steady gait and in no change in status.
After I received the shot, I walked out to the store to browse.  Within 1-2 minutes I began to feel lightheaded and my heart began to pound rapidly. I went back to vaccination area and sat down with pharmacist. My heart continued to pound rapidly for about another 4-5 minutes.  Once my heart slowed down,  I continued sitting about another 5min,  as I still felt lightheaded.  I then left the store to walk outside in fresh air. I had to sit down outside because I felt weak (about 15 min post shot) As I was resting,  my heart began to beat rapidly again for about 30sec-1min.  It took about 45m for my lightheadedness to fully subside.
Patient received MMR on 8-18-14. Patient came in to the office on 9-4-14 with faint erythematous maculopapular rash on abdomen, back and legs. On mid-abdomen and upper back there were a few petechiae. On 9-4-14 the patient was sent for a CBC with manual diff. Platelet count was 71,000. Dx: Thrombocytopenia. CBC will be repeated 9-11-14 and seen in office.
Pfizer BioNTech COVID-19 Vaccine EUA: Moderna COVID-19 Vaccine EUA Patient received Moderna Vaccines on 1/8/2021 and 2/2/2021 at  Allergy & Asthma. Patient presented to  Vaccination Clinic -  on 9/10/2021, and received a Pfizer vaccine.
The CDC changed the correct Moderna vial, 3 weeks after the state changed to all patients get Bivalent COVID vaccines. The correct vials were not available or available to order, at the time the state implemented this change.
Patient received TD injection on 04/15/08 and developed redness and hardness at the injection site.  Patient was treated for cellulitis with AUGMENTIN for 10 days.  Patient recovered.
The day after the vaccine my left shoulder was frozen. I had a hard lump that was painful at the place where I got the shot. I could not raise my arm to dress myself. One week later I woke up and I was very swollen from my neck to my upper arm. I woke up and my arm was on fire and it was very itchy. It was all the way down my arm and the focal point of the pain was around the injection site. I was prescribed some antihistamines and some muscle relaxers. After six months I still have no range of motion and my arm gets numb. Since I returned to work I have had chronic pain and I am using Lidocaine patches. Anytime my arm is at a 90 degree angle it goes numb and I am experiencing nerve pain. It feels like a nerve compression and I get sharp pain in my clavicle and down my back. I get burning and tingling in my fingers and I can?t sit still for long. My range of motion has improved since I started Physical Therapy. I got my second shot in the same arm but I premedicated with some muscle relaxers and antihistamines. My reaction was much less that time. I have pain every day and it is very bad by the end of my work day and physical activity is not possible right now.
Information has been received from a pharmacist concerning a 53 year old female who in undergoing chemotherapy and has a hx of rxns to drugs who on 26DEC2003 was vaccinated with a dose of pneumococcal 23v polysaccharide vaccine. On 27DEC2003 the pt developed an itchiness between her fingers on each hand and on each ankle. The pt took oral Benadryl and that helped the itching. As of the morning of 29DEC2003, the itching was still present. It was also noted that the adverse event abate. Unspecified medical attention was sought and treatment was required. A product quality complaint was not involved. Additional information has been requested.
in the evening after vaccination, pt experienced chills and loose stools. Resolved by next day 3 days later (on 5/23/22), pt started with tenderness and local edema of erythema of left deltoid (site of meningitis injection). Worsening on 5/24, then started to improve on 5/25 when pt was seen in clinic
Woke up extremely fatigued,  sinus congestion, headache, dizziness, chills on  03/23/2021, lasted a couple of days. Rash started on 03/26/2021 around injection site. Rash grew in size, became very red, swollen, and hot.  On 04/05/2021, discoloration on left arm is still noted, but no longer itchy, dark red, or swollen. UTI /kidney infection symptoms noticed on  04/01/2021.
sore arm; COVID-19; Drug ineffective; coughing; congestion; nasal drainage; sore throat; pressure around her cheek bones; headache; This spontaneous case was reported by a consumer and describes the occurrence of COVID-19 (COVID-19), DRUG INEFFECTIVE (Drug ineffective), PAIN IN EXTREMITY (sore arm), COUGH (coughing) and NASAL CONGESTION (congestion) in a 67-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 027L20A and 031L20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No medical history was reported by the reporter.  Concomitant products included CELECOXIB (CELEBREX), ATORVASTATIN, LISINOPRIL and LEVOTHYROXINE for an unknown indication.   On 12-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 12-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 05-Aug-2021, the patient experienced COUGH (coughing), NASAL CONGESTION (congestion), RHINORRHOEA (nasal drainage), OROPHARYNGEAL PAIN (sore throat), BONE PAIN (pressure around her cheek bones) and HEADACHE (headache). On 07-Aug-2021, the patient experienced COVID-19 (COVID-19) and DRUG INEFFECTIVE (Drug ineffective). On an unknown date, the patient experienced PAIN IN EXTREMITY (sore arm). On 07-Aug-2021, DRUG INEFFECTIVE (Drug ineffective) had resolved. At the time of the report, COVID-19 (COVID-19), COUGH (coughing), NASAL CONGESTION (congestion), RHINORRHOEA (nasal drainage), OROPHARYNGEAL PAIN (sore throat), BONE PAIN (pressure around her cheek bones) and HEADACHE (headache) was resolving and PAIN IN EXTREMITY (sore arm) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 07-Aug-2021, SARS-CoV-2 test: positive (Positive) Positive.         Treatment information was not provided.
Got COVID infection and tested positive in july 2021; Got COVID infection and tested positive in july 2021; This is a spontaneous report from a contactable consumer reporting for a female patient. A 64-year-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Formulation: Solution for injection, Lot number: unknown) via intramuscular route of administration on 16Mar2021 as Dose number Unknown, Single for COVID-19 immunization. Medical history included immunosuppression from an unknown date. The patient's concomitant medications included unspecified immune suppressing drugs. It was unknown if the patient was diagnosed with COVID-19 prior to vaccination. The patient has been tested for COVID-19 post vaccination. It was reported that the patient got COVID infection and tested positive on an unspecified date in July2021. The patient underwent lab tests and procedures which included COVID infection (sars-cov-2 test): positive on an unspecified date in July 2021. Adverse events resulted in none of the above. The outcome of events was recovering.   The lot number for the vaccine, [BNT162B2], was not provided and will be requested during follow up.
3:00pm arm soreness  5:00 pm total body soreness  6:00pm fever and chill through the night, unable to sleep  8:00pm lack of blood flow to toes, became cold white, then purple  11:00 pm fainting spells whenever I try to get out of bed 5:00am headache with aura
Received Tdap 08/04/08.  08/05/08-baled hay.  08/06/08 broke out in whelps.  08/07/08 private physician administered cortisone IM SINGULAIR & MEDROL dose pack.
Great amount of confusion; This spontaneous case was reported by a consumer and describes the occurrence of CONFUSIONAL STATE (Great amount of confusion) in a female patient of an unknown age 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 CONFUSIONAL STATE (Great amount of confusion) (seriousness criterion hospitalization). At the time of the report, CONFUSIONAL STATE (Great amount of confusion) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No concomitant medication reported. No treatment information was provided.  Company comment: Very limited information regarding this event has been provided at this time. Based on the current available information and temporal association between the use of the product and the start date of the event, a causal relationship cannot be excluded.  Further information has been requested; Sender's Comments: Very limited information regarding this event has been provided at this time. Based on the current available information and temporal association between the use of the product and the start date of the event, a causal relationship cannot be excluded.  Further information has been requested
2 days after injection site was red and warm to the touch, slightly painful. On Saturday, April 23, redness had spread to elbow. Patient called doctor's office on Monday and described situation and was told to take leftover AMOXIL 875. Patient took for 5 days and is much better and improved. Patient applied BENADRYL as well ADVIL helped.
About 9 hours after receiving 2nd dose of vaccine, patient awoke with quite significant itching (vaccine site as well head, neck, scalp, ears, trunk, arms, palms, and legs) , swelling around eyes (almost swollen shut), and tightness in chest. After 1st dose of vaccine, she had mild swelling around eyes and a little tightness in chest that she thought was related to pollen.
I got my second dose of the Moderna vaccine on 2/27/2021. On about 3/5/2021, I noticed that I had pain and swelling in the lymph nodes of the left armpit. I also had pain in my left shoulder and the entire left upper arm. I still have swollen, painful lymph nodes and pain in my upper left arm, though the pain is now less intense. I have recently also begun experiencing tingling in the fingers and palm of my left hand. I went to my PCP,  Doctor, on 8/23/2021, and she referred me to the Breast Center, where I received my yearly mammogram and an ultrasound of the lymph nodes in my left armpit on 8/25/2021. The results were normal. I am scheduled to see Doctor again on 9/28/2021.
DRUG EXPOSURE DURING PREGNANCY; CONFIRMED CLINICAL VACCINATION FAILURE; CONFIRMED COVID-19 INFECTION; This spontaneous pregnancy report received from a patient 38 year old, female. The patient's weight, height was not reported and medical history included Gravida 1. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of administration not reported, batch number: Unknown) dose was not reported ,frequency one total administered on 07-MAR-2021 to right arm for prophylactic vaccination. The batch number was not reported and has been requested. No concomitant medications were reported. On 15-APR-2021, the patient experienced confirmed covid-19 infection and confirmed clinical vaccination failure. Laboratory data included: COVID-19 PCR test (NR: not provided) Positive. On an unspecified date, the patient was pregnant (coded as drug exposure during pregnancy). The date of patient's last menstrual period was not reported and expected delivery date were not reported. The pregnancy was continuing. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from confirmed covid-19 infection, and drug exposure during pregnancy, and the outcome of confirmed clinical vaccination failure was not reported. This report was serious (Other Medically Important Condition). This report was associated with product quality compliant: 90000176751.; Sender's Comments: V0: 20210436428 -JANSSEN COVID-19 VACCINE Ad26.COV2.S- Confirmed clinical vaccination failure. This event is considered not related. The event has a compatible/suggestive temporal relationship, is unlabeled, and has unknown scientific plausibility. There are other factors more likely to be associated with the event than the drug. Specifically: SPECIAL SITUATIONS.
arm soreness; Racing heartbeat; little bit dizzy; Fever; Chills; Nauseous; Fatigue; A spontaneous report was received from a physical therapist concerning a fifty-five-year-old, female patient who received Moderna's COVID-19 Vaccine (mRNA-1273) and experienced fever, chills, heartbeats increased, arm soreness, nauseous, fatigue and dizzy.   The patient's medical history was not provided. Concomitant medications reported included Synthroid.  The patient received their first of two planned doses of mRNA-1273 (BATCH # 026L20A) on 12 Jan 2021 intramuscularly in the left arm for prophylaxis of COVID-19 infection.   Reporter called and stated they were a physical therapist who received their first dose of Moderna COVID-19 vaccine in their left arm at her place of work on 12 Jan 2021 and experienced fevers, chills and racing heartbeat. She stated she was better now but that she wanted to know, if they should receive the second vaccine. She had arm soreness but stated it was expected. Twelve hours after reporter received the vaccine, she was nauseous and experienced fatigue, chills and elevated heartbeat. She also had a fever. As of the day of this report, fever was down but persisted, and heartbeat was down. She still felt a little bit dizzy. Reporter just stayed in bed and did not take any medicines to treat the symptoms. Reporter was currently on Synthroid  No treatment information was provided.  Action taken with RNA-1273 in response to the event was unknown.  The outcome of the events chills, arm soreness, nauseous and fatigue was unknown. Fever, heartbeats increased and dizzy were resolving.  The reporter did not provide an assessment for the events, fever, chills, heartbeats increased, arm soreness, nauseous, fatigue and dizzy.; Sender's Comments: Based on the current available information and temporal association between the use of the product and the start dates of the events, a causal relationship cannot be excluded.
Information has been received from a physician concerning a 24 year old male patient who on 04-JUN-2010 was vaccinated with a dose of VARIVAX (Merck). Concomitant therapy included ALLEGRA. On 24-JUN-2010 the patient experienced severe headache and fever. On 26-JUN-2010 the patient broke out with 5-7 vesicles which tested positive for varicella. The patient sought unspecified medical attention. Lab test for varicella antibody showed positive. No treatment was required at this time. At the time of the report, the patient had not recovered. Additional information has been requested.
Rash, fever, pruritus - Information has been received from a consumer concerning her 4 year old daughter with a past medical history of possible rolandic seizures and no known allergies who in approximately April 1999 was vaccinated with measles virus vaccine live (+) mumps virus vaccine live (+) rubella virus vaccine live (second generation).  There was no concomitant medications.  Approximately 10 days post-vaccination the patient had a fever and broke out in an itch/rash all over her body.  The patient sought unspecified medical attention.  The patient's sister (WAES #00071056)  had a similar experience following exposure to measles virus vaccine live (+) mumps virus vaccine live (+) rubella virus vaccine live (second generation).  Follow up information from the physician indicated that the patient had no adverse reactions related to the measles virus vaccine live (+) mumps virus vaccine live (+) rubella virus vaccine live (second generation).  No further information is expected.
Site: Bruising at Injection Site-Medium, Site: Swelling at Injection Site
1st dose 11Oct2022, 2nd not yet; This case was reported by a pharmacist via call center representative and described the occurrence of incomplete course of vaccination in a 60-year-old male patient who received HAB (Twinrix) for prophylaxis.   Co-suspect products included hepatitis A and hepatitis B vaccine pre-filled syringe device (Twinrix Pre-Filled Syringe Device) injection syringe for prophylaxis.   Previously administered products included Twinrix (received first dose on 11th October 2022).   On an unknown date, the patient did not receive the 2nd dose of Twinrix and Twinrix Pre-Filled Syringe Device. On an unknown date, unknown after receiving Twinrix and Twinrix Pre-Filled Syringe Device, the patient experienced incomplete course of vaccination. On an unknown date, the outcome of the incomplete course of vaccination was unknown.     This report is made by GSK without prejudice and does not imply any admission or liability for the incident or its consequences.   Additional Information: GSK receipt date: 31-Jan-2023 Reporter's comment: A pharmacist called to ask for information regarding the patient who did not receive the second dose after 1 month of first dose. The reporter asked if they could administer the second dose or if the patient had to start over with vaccination. The reporter did not shared Twinrix first dose lot number and expiration date. Did not consent to follow-up. Additional supportive information: Till the time of reporting, the patient did not receive second dose of Twinrix, which led to incomplete course of vaccination.
Patient fainted 10 minutes post vaccine while waiting the 15 minutes in our observation area. He fell out of the chair and hit his head on the floor. He sustained a left frontal abrasion. He was alert and oriented x 3, no neck pain, pale, able to move hands and legs. Ambulated to private car to be taken to the ER for evaluation and r/o concussion.
he has been feeling generally worse the past week or so./he has been feeling progressively worse, more exhausted and more pain primarily in the joints/Joints were really sore: hand, wrist, shoulders, hips and through his legs/Joint pain/Fatigue; arthritis; some muscle pains; sick; joints were really sore: hand, wrist, shoulders, hips and through his legs/Joint pain; very tired/tremendous fatigue; This is a spontaneous report from a contactable consumer (patient).   A 65-year-old male patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, Batch/Lot Number: EN6202) (at the age 65-years-old), via an unspecified route of administration on 03Mar2021 16.05 as dose 1, single for covid-19 immunization. Patient had no known allergies. The patient relevant medical history includes blood pressure high and minor prostate surgery (start date- unspecified date  in Dec2020) The patient concomitant medications were not reported. The patient previously received Flu shots on an unspecified date for flu like symptoms. The patient received his 1st dose of the Pfizer covid vaccine on 3Mar2021 in the afternoon and the patient had a normal evening. On the next day, the patient was very tired and had to call in sick to work and was not even up to teleworking.  It seemed to got better but was still persistent. The patient had to take a 1 hour nap a day since the vaccine and his joints was really sore: hand, wrist, shoulders, hips and through his legs. It was an annoyance initially but kept getting more noticeable. The patient was on vacation in (State), left last week, as they was arriving up and experienced increased difficulty every day getting out of bed and in and out of the car, his wife had to help him. Did not know what arthritis feels like but based on what everyone said, it feels like it and gotten worse. The patient did not hike or do anything. The patient feeling generally worse the past week or so and had gotten a number of symptoms arthritis, difficulty moving his hands and very sore. The same thing with the patients hips, shoulders and legs and had tremendous fatigue. The patient feeling progressively worse, more exhausted and more pain primarily in the joints and had some muscle pains as well. The patient did not know if it was related to the vaccine and was calling to find out if this was related to the vaccine. The joint pain started on 07Mar2021 or 08Mar2021, it really started bothering him towards the end of last week, 11Mar2021 or 12Mar2021. The patient went on the trip on 13Mar2021 and that's when it started really bothering him and any time the patient moves it was painful, he did not had full range of motion in his arms and legs. The outcome of events illness, myalgia, arthritis, arthralgia and fatigue was unknown and the outcome of condition aggravative was not recovered.  No follow-up attempts are possible. No further information is expected.
This spontaneous report as received from a physician refers to a patient of unknown age and gender. The physician reported that the patient receive the first dose of GARDASIL (dose and route not reported) series on an unspecified date in May-2012 and the second dose in the series "about a week ago", approximately on 18-APR-2013 (dose and route not reported). No adverse effect was reported. No further information is available. Additional information has been requested.
I woke up on 5/29/2021 at around 5AM EST with a heavy chest, shortness of breath, and a sore throat. It felt like I could only breath in for about a second and a half without a lot of strain or coughing. It is now 10:41 AM and I still have a heavy chest and shortness of breath but it is much more manageable than before. I still can't take a full breath, but I can breath in for about 5 seconds before it feels like something is blocking me from going further. No current pain.