chrisvoncsefalvay/vaers-outcomes huggingface dataset:
within 24 hours of receiving the covid vaccine on 12/30/2020 at 9:20am at work, my arm swells and there was a painful lump. i was told that was normal.  it's been 2 wks , the swelling went down but the lump is still there, and painful when touch. feels hot. I was told to consult with my PCP but he doesn't know because "we  use Pfizer here, not Moderna. Follow the website link." The site where the vaccine was given looks like my skin is discolor now -turning brown like leaving a mark around the lump (birth mark look like).
flu like;swollen lymph glands in throat eyes became very red, pus formed for 24hr;chills, fever, sore muscles in legs;
Soreness and redness/itching at injection site appeared a bout 6 hours after vaccine. Headache and nasal  stuffiness began 7 hours after vaccine and continued for 36 hours. Body aches and joint pain began 9 hours after vaccine and continued for about 30 hours. Chills began 12 hours after vaccine and continued for 12 hours until 200 mg ibuprofen taken. Fever began 12 hours after vaccine,  and continued for 15 hours.  Highest temperature was 101.6 12 hours after vaccine. All symptoms (except injection site soreness and redness) were greatly relieved by taking 200 mg of ibuprofen every 4 hours, starting 12 hours after vaccine.
Mom called states increased swelling from hip to ankle greater on (R). Inconsolable crying x 4 hrs, high-pitched. Not reported till 11/20. Contacted Mom 11/21/13. States leg was twice the normal size.
Systemic: Fainting / Unresponsive-Medium, Systemic: loss of color, unresponsive, sweating. epipen given. ems evaluated and determined stress rxn and sent home. -Medium, Systemic: Flushed / Sweating-Medium
Pain in arm, joint pain, swollen gland in armpit (very painful and large), sensitive skin, fatigue
Patient was administered her second Moderna vaccine 1 day outside of the grace period of 4 days.
Dtap vac durring pregnancy.  Baby due nov. 22. Arm was sore at injection location in arm.  Full body aches and pain by dinner. Impossible to sleep in pain at night.  Difficult to walk next day.
Injection given approximately 10:45 AM. Girlfriend reported approximately 5:45 PM patient - shaking, swelling, vomiting - talking out of head - crying taken by ambulance to hospital.
PT FAINTED AFTER GETTING VACCINE, PT CLAIMED THAT SHE FELT DIZZY BUT DID NOT WANT TO LAY ON FLOOR. SHE SAT  IN A CHAIR,  LOST CONSCIOUSNESS AND HIT HER HEAD AS SHE FELL TO THE FLOOR. PHARMACIST RUSHED TO HER, TURNED HER ON TO BACK AND SHE REGAIN CONSCIOUSNESS. GAVE HER WATER ICE PACK FOR HER HEAD AND A GLUCOSE TABLET. SHE REMAINED IN STORE AN ADDITIONAL 30 MINUTES,AND HER HUSBAND CAME TO PICK HER UP
R axillary lymph node edema, pain at injection site, lethargy, nausea, weakness,
ended up with pneumonia; could not breathe; becomes ill/Sick; This case was reported by a consumer via call center representative and described the occurrence of pneumonia in a 70-year-old female patient who received Flu Seasonal QIV Dresden (Influenza vaccine Quadrivalent unspecified season) for prophylaxis.   Concurrent medical conditions included lung disease and drug allergy.   On an unknown date, the patient received Influenza vaccine Quadrivalent unspecified season. On an unknown date, less than 2 years after receiving Influenza vaccine Quadrivalent unspecified season, the patient experienced pneumonia (serious criteria GSK medically significant), difficulty breathing (serious criteria other: serious by reporter) and malaise. Influenza vaccine Quadrivalent unspecified season was discontinued. On an unknown date, the outcome of the pneumonia and malaise were recovered/resolved and the outcome of the difficulty breathing was unknown.   It was unknown if the reporter considered the pneumonia, difficulty breathing and malaise to be related to Influenza vaccine Quadrivalent unspecified season.  Additional details were provided as follows: The age at vaccination was not reported. After receiving flu vaccine, the patient became ill because the flu shot was made with a chicken protein.  The patient stated that, she would stay sick for months. She said this happened 2 years in a row and she ended up going to the emergency room by ambulance because she could not breathe.  The patient also ended up with pneumonia which she got 3 times in a year and a half after the flu shots were received.  The patient had since recovered from all of these events, but she stated, she was not going to get a flu shot again.  The patient did not know the name of the flu shots she received but said we could contact her doctor for that information.  The patient was calling GlaxoSmithKline, because she wanted to know if Shingrix had any chicken or fowl protein in it.  She stated, she had the first shot of Shingrix on Friday 21st August 2020 and the last few days she was coughing a lot.  For the tolerance of dose of Shingrix, refer the linked case US2020AMR170918. This was 1 of 3 linked cases reported for the same patient.; Sender's Comments:  US-GLAXOSMITHKLINE-US2020AMR170986:same patient US-GLAXOSMITHKLINE-US2020AMR170918:same patient
This report was identified from a line listing obtained on request by the Company from the FDA under the Freedom of Information Act referring to a 15 year old female patient. The patient's concurrent condition included warts on the foot. Information about concomitant medication and medical history was not provided. On 03-MAY-2016, the patient was vaccinated with the third dose of GARDASIL 9 (lot # L038503, expiration date, dose and frequency unknown, intramuscular in the left arm) for prophylaxis. On 07-JUN-2017, the patient's stepmom stated that the human papillomavirus (HPV) vaccine had given patient a lot of symptoms including hand tremors, nausea, lethargy, personality changes, bipolar symptoms as well as hives, weight gain, jaw pain, nausea, vomiting and headaches. The patient did not present for medical evaluation. The patient's current status is undocumented. On an unknown date, the patient's stepmom came into the office for consult without patient. Rheumatology referral was sent per stepmom's request. The outcome of the events was reported as not recovered. The causality assessment was not provided. Follow-up information has been received from the patient's mother and the vaccine administrator via the FDA (agency# 701180) on request by the Company under the Freedom of Information Act on 15-APR-2019. It was reported that the patient received the first dose of GARDASIL 9 (lot number and expiration date not provided) on 24-MAR-2015 and the second one on 03-MAY-2016 (previously reported as a third dose). Regarding the onset of the event, it was reported as: "2 years of illness". Additionally, it was reported that "they were doing lab tests". Follow up information has been received from  a Nurse on 30-MAY-2019. The nurse did not wanted to share any additional identifying information for patient. The nurse shared that the patient had the events prior to her vaccination. She also reported that the physician did not think the vaccine caused any of these events.
Patient fainted.  Patient fell onto floor and hit face.  Paramedics arrived and transported to hospital due to low blood pressure. Determined to be a response to stress of vaccination.  Patient needed stitches to repair cut in lip from fall.
It was noted later that no new vaccine vial was removed that day the vaccine was given; presume that vial from previous day was used. The vial was kept at appropriate refrigerated temperature but punctured on 1/17/23 (more than 8 hours prior). Patient was notified and agreed to schedule a follow up vaccine dose appointment.
L upper arm w/ red full mildly indurated 12 x16 cm reaction.
severe h/a & subjective fever began w/in 24 hrs of vax being administered; h/a lasted off & on for 3 days;
This is a spontaneous report received from contactable consumer or other non-HCP (patient). Other case identifier: 02010582. A patient (no qualifiers provided) received the 1st dose of BNT162B2 (Pfizer-BioNTech COVID-19 vaccine, batch/lot# unknown), single dose, for COVID-19 immunisation.  Medical history and concomitant medications not reported. The patient experienced dizziness (dizzy), with outcome of unknown. Therapeutic measures were taken as a result of dizziness. Additional information: Patient received the Pfizer COVID-19 vaccine and had light side effects like dizzy spells after the first dose. Patient felt horrible and was debilitated for a week; took Tylenol for side effects. No follow-up attempts possible. Information about batch/lot number cannot be obtained. No further information expected. Sender's comments: Linked report: US-PFIZER INC-202101252700 (same patient and reporter, different dose and event).
This spontaneous case was reported by a patient and describes the occurrence of EXPOSURE VIA BREAST MILK (breastfeeding) in a 24-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 045A21A) for COVID-19 vaccination.     No Medical History information was reported.    On 22-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced EXPOSURE VIA BREAST MILK (breastfeeding). At the time of the report, EXPOSURE VIA BREAST MILK (breastfeeding) outcome was unknown. Not Provided      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 concomitant medications were reported.  No treatment was provided for the event that was reported.   Most recent FOLLOW-UP information incorporated above includes: On 12-May-2021: Live follow up received.No new information was updated.
This spontaneous report was received from a medical assistant, and refers to a 14 year old patient of unknown  gender. Information about the patient's medical history, concurrent conditions, concomitant medications and drug reactions or allergies was not provided. On 28-MAR-2019, the patient was inadvertently vaccinated with an expired dose of VAQTA (lot # R010368 with an expiration date in 25-MAR-2019), intramuscularly, for prophylaxis (strength, dose and frequency were not provided). No adverse effects were reported.
the pain is going up higher and higher.; I feel flush; Flu like symptoms; Arm pain; This is a spontaneous report from a contactable consume. A 78-years-old female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Lot Number: EL3249) via an unspecified route of administration in Arm left on 21Jan2021 11:00 (Age at time of Vaccination: 78-years-old) as single dose for covid-19 immunisation.Medical history included ongoing blood pressure abnormal, arthritis, gastrooesophageal reflux disease. She also takes a medication for reflux, but does not know the name of it. The patient's concomitant medications were not reported. On 23Jan2021 the patient experienced flu like symptoms, arm pain. On an unknown date the patient stated the pain is going up higher and higher and I feel flush. She got the vaccine last thursday, on 21Jan2021. She stated she was fine the day after, but then the next day she started to get flu like symptoms. She is also having arm pain and the pain is going up higher and higher. The pain is going up behind her head, it is hurting there too. She wants to know why she has not stopped hurting. She stated she kept taking Ibuprofen thinking that was a good thing to do. However, she would only take half of it.Therapeutic measures were taken as a result of flu like symptoms, arm pain , the pain is going up higher and higher. It was reported that she is scheduled for the second dose on 11Feb2021. No prior vaccinations was given to patient within 4 weeks. The outcome of the event flu like symptoms and arm pain was not recovered and outcome of other events was unknown.
Patient recieved the vaccine on 29 Jan 03. On 06 Feb 03 he presented in the local ER with complaints of headache, nausea, fever, chills and reddness and swelling around the vaccination site. He was diagnosed with cellulitis and released.  He returned on Monday 10 feb 03, with worsening edema and erythema, that was now spreading down his lt arm.  He was admitted to the hospital for IV antibiotics. He did well and was released two days later, much improved.
About 2 hours after receiving H1N1 developed sore throat, stomach ache, fever, migraine, diarrhea. Fever until next day. Temp at about 11p Mon 11-9-09 was 101 degrees - 1:30 am on 11-10-09 was 104 degrees. Per TC to client 11-12-09 felt better except for sore throat and some diarrhea.
Started screaming middle of night randomly (appeared scared). Then crying/ screaming/ tantruming all day. Get injection site started to get red today and progressed as day went on. She's been miserable. Then around 445 pm she started vomiting. Also not sure exact vaccine - just know it was dtap with polio combo.
I had body aches, slight headache and felt drained of energy.  Flu like symptoms
Muscle aches- 2 days following shot Fatigue-2 days following shot Tingling and numb fingers, right hand- still present Back of ankles  and calf's - sore muscles,started 6 days after shot till present. Sore where shot was injected-for 6 days
Pt developed fever of 101.0 1 hour after vaccine administration. She began vomiting shortly after and has now been vomiting at least 3 times a day each day since vaccine administration. Her fevers have continued with a maximum temperature of 101.2. Vomiting continues but is not associated with abdominal pain or diarrhea; she also has no nausea but only a sudden intense urge to vomit.
bilateral numbness cheeks and jaw, difficulty swallowing Narrative:  College med student received COVID vaccine 30mins later had numbness in both cheeks and jaw, 40mins after vaccine he had difficulty swallowing. No SOB, No resp distress, no noticeable swelling of tongue
Information has been received from a registered nurse concerning her 16 month old son who on 10/01/2004 was vaccinated with a dose of measles virus vaccine live.  The nurse reported that her son was healthy at the time of vaccination.  On 10/06/2004, the patient developed a fever and cough.  Medical attention was not sought for the patient's experience.  At the time of this report, the patient had not recovered. Additional information has been requested. This is a follow-up to report (s) previously submitted on 1/21/2005. Information has been received from a registered nurse concerning her 14 month old son with no relevant medical history reported who on 01-OCT-2004 was vaccinated subcutaneously with a first dose of ATTENUVAX vaccine (Enders-Edmonston) (lot 647584/0906N). The nurse reported that her son was healthy at the time of vaccination. On 06-OCT-2004, the patient developed a fever and cough. Medical attention was not sought for the patient's experience. At the time of this report, the patient had not recovered. Follow-up information was received from a physician who reported that the patient did not have any reaction as a result of the vacciantion. The patient happened to have a cough at the time. No fever noted. There were no laboratory tests performed and the patient did not experience any adverse events following prior vaccinations. It was noted that the patient is well. No additional information is expected.
pt recvd vax 8AM & approx 4PM devel nausea, vomiting, severe dizziness, diarrhea, facial edema, hives, & h/a;
On 4 December, in the afternoon I had loss of appetite and a drop of energy with 99degrees which is a low grade fever for me. I slept for a long time which was over 10 hrs. By Monday fever 102.5 which a lot of aches and chills . Then I continued sleeping with zero appetite, very weak and fatigue. Mild congestion.  I only drank tea for the 3 days. The food tasted super bland when I ate it.  I contacted my doctor on 12/7/22 via telehealth. I had no fever but I took Tylenol. The fatigue and loss appetite   lasted till 12/13/2022. After the 12/14/22 I felt normal. It long time till I got back my stamina. I had COVID-19 again Mar2023 where I had a scratchy throat, chills and a drop in energy and low appetite . The next day I woke up coughing and the temperature was 99 and lost of sleeping. I though it was a head cold or a cough. It was not as bad as the last time I had COVID-19. I took Nightquill on Monday night  evening Dayquil and Suphedrine PE on Tuesday. On Wednesday, I had lots of congestion with cough and my voice was like laryngitis but no sorethroat until Friday. On Saturday I felt better.
Tingling and numbness of tongue, throat and lips Facial and neck itch and redness Minimum difficulty breathing
Patient reported left arm stiffness day after administration and her arm locked up. Later in the day at night she reported a stiff neck in addition to locked arm. The next day she developed a rash on her back, neck, hairline to front of her shoulder blade and down her legs.
Starting 05/04/2022, I began to get a sore throat. 05/05/2022 I developed a stuffy and runny nose. 05/06/2022 I developed a cough and it persisted which made me think it was more than a cold. On 05/07/2022, I took 2 at home tests (both were positive). So, I then called the doctor and went in, per their recommendation, to get a more formal COVID test in office, which I did around 2:00PM on 05/07/2022. Then 05/09/2022, at around 06:00am it was confirmed I had COVID. I called my PCP after I got the results and they sent in an rx for Paxlovid which I started taking at around 09:00pm that evening. Since then, my cough has improved, my runny nose has improved but I have had a bit of a raspy throat this morning.
It's blood in my urine and I am having lower back pain. The bleeding is intermittingly visible. Sometimes it's visible and some days it's not. I was referred to a specialist from my PCP. I am still being tested to have a diagnosis. I did have to go to urgent care on 12/08/2022. I was told the noticed blood and protein in the urine, and I saw my PCP after that.
Date and time is approximate - it was definitely before 10/23.  Pain in my upper left shoulder.  Went to Dr in November - started phys therapy and am still going.  Received one cortizone shot in January.  Diagnosed with adhesive capsulitis.  I am still in treatment.
Vaccine vial which has black particles in it; A spontaneous report from a vaccine administrator/reporter/pharmacist concerning Moderna's COVID-19 vaccine (mRNA-1273) (lot# 036A21A) (PC number: 7154) vial that had black particles and administered 2 doses before noticing the change.  No details were provided about the patients.   No events were reported.  Action taken, outcome and causality are not applicable.; Reporter's Comments: This report refers to a case of poor quality product administered for mRNA-1273, lot # 036A21A with no associated AEs. Causality for this medication error is not applicable
mom reports pt took nap on return home; awoke approx 1130AM covered w/red blotchy bumps on face, eyes starting to swell; no fever or dyspnea; On MD phone advice mom gave DPH; no improvement; back to MD office given adrenalin;
Pt vaccinated with TTOX developed edema/periph limitation movement lt arm & shoulder.
12/17/21 presents to ED for "generalized weakness". PMHx of "poliomyelitis, schizophrenia, DM, HTN, and HLP"
Pt. presented with severe rash and pallor->noticed blotching and red areas on back, chest and extremities->pt. also c/o of dizziness; no SOB or edema in/within airway->administered 50 mg. BENADRYL->continued to monitor pt for D->including BLVS and continuing VS->administered 0.3 EPI 1:1K L Deltoid->called rescue->transferred care.
This spontaneous case, initially received on 01-Jun-2017, was reported by other health professional (registered nurse) and concerns students in an academic campus, who received flu vaccine. This case deals with ninth report out of 23 reports. From 03-Oct-2016 to 04-Oct-2016, 176 students were vaccinated with FLUCELVAX in the total of 258 students in the campus. In the spring of 2017, an outbreak of the flu occurred and lasted for approximately 10 days. The reporter stated that, from 13-Apr-2017 to 18-Apr-2017, they treated 22 students with flu and among them 5 students had the vaccine on campus. In the beginning of 18-Apr-2017, they treated another 23 students with flu symptoms and only 3 of those had not received the flu vaccine. The students were tested positive for influenza A via rapid flu test with nasopharyngeal swab. This case concerns a 16-years-old patient of unspecified gender. On 03-Oct-2016, the patient received FLUCELVAX QIV (dose, route of administration and anatomical location: not reported, batch number: 185888, expiration date: 31-May-2017). On 19-Apr-2017, the patient was tested positive for influenza A via rapid flu test with nasopharyngeal swab (characterized as vaccination failure). Based on the investigation performed, it can be concluded that FLUCELVAX 185888 was manufactured in compliance with the approved internal procedures and in accordance with the quality requirements. No evidence was found that the LOE complaint was the result of the Fill Finish or Bulk manufacturing process and no trends were identified for the batch number 185888, or any other FLUCELVAX QIV batches from the 2016-2017 FLUCELVAX Commercial season. Therefore no internal root cause could be confirmed. Outcome of influenza A virus infection and vaccination failure was not reported. The reporter did not assess the seriousness and did not provide the causality between events and suspect vaccine. The reporter stated that, the students received flu vaccine had less severe symptoms than those who had not received the flu vaccine. The flu vaccine was effective in mitigating the spread of the flu on campus and decreases one's chances of getting the flu with 99 percent certainty. Batch review report (QAIR number 1022277) received from quality assurance department on 29-Jul-2017: QA investigation results were updated. Narrative amended accordingly.
Red swollen area shoulder anterior chest axilla, 2/3 down to elbow, 1 inch approx area of white color, red area sore, bruising appearance in part of upper arm appears various stages. Ordered ZPAK one course.
Severe nausea the next day. Today, dizziness and nausea started. Room spinning dizziness.
This spontaneous report as received from an office worker refers to a patient of unknown age and gender. The patient's historical drugs, medical history and concurrent conditions were not reported. The patient's concomitant therapies included MERCK STERILE DILUENT. On 12-OCT-2017, the patient was vaccinated with an expired dose of PROQUAD rHA, lot # M017336, expiration date 12-OCT-2017, for prophylaxis (strength, dose, route and frequency were not reported). No adverse effect reported. Lot number M017336 has been verified to be a valid lot number for measles, mumps, rubella and varicella (oka-merck) virus vaccine live.
The office contacted the patient 09/12/2018 per the parent there were no reactions to the vaccine. Asked if there was swelling,redness, fever, rash or any other symptoms after receiving the vaccine. Per the parent there were none.