chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Hives all over body starting about a week following the shot, sensitivity to heat (breaking in to hives) and pressure, joint pain in both arms - at time debilitating
She was anxious before getting the shot @ 1615. Appears anxiety attack after shot. Denied shortness of breath, headaches and dizziness. At 1630 heart rate 116 bpm. Offered ice pack and cold water. At 1637 heart rate 87 bpm. OR Sat 99%. Stated feeling better. At 1645 Went home with stable conditions.
Narrative: Patient with breakthrough Covid infection. Received two doses of moderna vaccine previously. Treated with monoclonal antibody therapy.
Sporadic bumps showing up all over my body, one on the bottom of my foot. Most were very itchy. Seemed to flare up when fatigued or during sleep. They would be red and raised, almost like a small mosquito bite. Then they would dissipate, although some would leave a tiny red dot.   Almost seemed that there was a bug in my clothing, so I showered, changed my clothes, and searched thoroughly in bed, closet, clothes for, bugs but there were none. My wife also did not get any of these itchy bumps in spite of sharing a bed.   It may be worth noting that my wife got shingles 10 days after receiving the 1st Pfizer dose.
Shot 1 was administered in alternate location on 8-3-21.  Shot 2 was administered in another alternate location on 9-14-21.  There were no reactions to either shot.  Around 13 January, I started having calf pain and went to my PCM.  He classified my injury as an inner soleus tear initially.  After the injury worsened and I went to the ER on 3 February, I found out that it was not an injury, rather an exceptional case of DVT.  I started Xarelto on 4 February, and have been on blood thinners since.  I still have a clot in my leg and might need surgery if the clot does not dissolve.  I am due to go back to the doctor to get a follow-up ultrasound in several weeks.  I am completely healthy and work out 6-7 days a week.  I have no other health problems and believe that my DVT was caused by the vaccine.
Patient reported eating and having a beer after getting his vaccine.  A couple of hours later he experienced difficulty breathing (shortness of breath/tightness).  He said it lasted for about an hour and then went away.  He has since been fine.
Developed fever the night the shot was received. Pt reports temperature of 102F-103F. Took ASA to reduce fever (2 tablets) X 1. When pt awoke the next AM, he had head congestion, stuffy nose, sinus pressure and right ear "completely plugged". Pt complained of continued head congestion to this day.
Maculo papular rash on B/L arms and (L) Lat - abdomen - hydrocortisone applied.
Case previously recorded as MA2009-4570. Case report received from an office manager via physician, via MedCom, on 12 NOV 2009. 11-month-old male patient was vaccinated with 0.25 mL of S-OIV FLUVIRIN (batch no. 102045P1) i.m. into right thigh on 10 NOV 2009. No adverse effect was reported. MedCom reference no.:NA09-008038.
2 days of intermittent fevers, chills, injection site pain, weakness, inappetance, and today full body muscle spasms/cramps. First episode lasting over an hour, second episode lasted about 10 minutes.; 2 days of intermittent fevers, chills, injection site pain, weakness, inappetance, and today full body muscle spasms/cramps. First episode lasting over an hour, second episode lasted about 10 minutes.; 2 days of intermittent fevers, chills, injection site pain, weakness, inappetance, and today full body muscle spasms/cramps. First episode lasting over an hour, second episode lasted about 10 minutes.; 2 days of intermittent fevers, chills, injection site pain, weakness, inappetance, and today full body muscle spasms/cramps. First episode lasting over an hour, second episode lasted about 10 minutes.; 2 days of intermittent fevers, chills, injection site pain, weakness, inappetance, and today full body muscle spasms/cramps. First episode lasting over an hour, second episode lasted about 10 minutes.; 2 days of intermittent fevers, chills, injection site pain, weakness, inappetance, and today full body muscle spasms/cramps. First episode lasting over an hour, second episode lasted about 10 minutes.; This is a spontaneous report from a non-contactable consumer, the patient. A 43-year-old male patient received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: Ew0168) via an unspecified route of administration in the right arm on 21May2021 at 15:15 (at the age of 43-years-old) as a single dose for COVID-19 immunisation. Medical history included asthma. Concomitant medications taken within two weeks of vaccination included dextromethorphan hydrobromide, doxylamine succinate, ephedrine sulfate, ethanol, paracetamol (NYQUIL) from unknown date for unknown indication. The patient previously took acetylsalicylic acid (ASPIRIN) and ibuprofen, both for unknown indication and experienced drug allergy. Prior to the vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. The patient did not receive any other vaccines within four weeks prior to the vaccination. On 22May2021 at 06:00, the patient experienced two days of intermittent fevers, chills, injection site pain, weakness, inappetance, and on 23May2021, the day of report full body muscle spasms/cramps. First episode lasting over an hour, second episode lasted about ten minutes. The events did not result in doctor or other healthcare professional office/clinic visit, emergency room/department or urgent care. No therapeutic measures were taken as a result of the events. The clinical outcome of the events two days of intermittent fevers, chills, injection site pain, weakness, inappetance, and on the day of report full body muscle spasms/cramps; first episode lasting over an hour, second episode lasted about 10 minutes was unknown at the time of this report.   No follow-up attempts are needed. No further information is expected.
hives; troubles with breathing; This is a spontaneous report from a non-contactable consumer. This consumer (Wife) reported for a male patient (Husband). A male patient of 6 decades (70s) received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: unknown), via an unspecified route of administration on 15Jan2021 as a single dose for COVID-19 immunization. The patient medical history included that he got sick of Covid-19 last Mar. The patient concomitant medications were not reported. The patient and his wife both received the 1st dose of the Pfizer-BioNTech Covid-19 Vaccine on 15Jan2021, experienced some bad reactions to COVID vaccine afterwards. She said these reactions included hives, and they had troubles with breathing for 3 days. She also said she has already consulted her doctor about it and was told that they should not receive the 2nd dose of the vaccine since she experienced an allergic reaction after the 1st dose. They were also told that they should not have received the 1st dose in the first place since they still have the antibodies from when they got sick of Covid-19 last Mar. Consumer is seeking clarification if this is true, and if this reaction is associated with the vaccine. They both had COVID in Mar2020. The blood test says they have antibodies. But they had opportunities to get the shots. His wife was  worse than him. It took her 3 days to come out of the reaction, and it took him 1 day. After this experience, they went to see their primary doctor. They told him what happened. He didn't have it as bad. His wife couldn't breathe, and she was heaving for 3 days. They are afraid the second shot will do the same. Caller doesn't want to document this with safety. He just wants to get over to Medical Information. The outcome of the events is unknown.    Information on the lot/batch number has been requested.  Follow-up attempts are completed. No further information is expected.  Follow-up (04Feb2021): This is a follow-up spontaneous report from a contactable consumer. This consumer reported that: Medically significant information added.
Initial unsolicited report received from a nurse on 26 October 2015. "That report is from a Partner and contact information in based upon the location of our trading partner". This case involves a male patient (age was not reported) who was vaccinated with dose of TDAP Vaccine (batch number, dose, dose in series, route and site of administration were not reported); with a dose of Flu Vaccine (batch number, dose, dose in series, route and site of administration were not reported) and with PREVNAR 13 (batch number, dose, dose in series, manufacturer: other, route and site of administration were not reported) on an unspecified date. The patient was a heart transplant recipient. Concomitant medications were not reported. On an unknown date following the vaccination, the patient developed a fever of 104 degree Fahrenheit and taken to the emergency room. Laboratory data and corrective treatment was not reported. The outcome of the event was not reported. List of documents held by sender: none.
pt recv vax 10JUN96 & devel chickenpox on 28JUN96, which is 18 days p/vax;pt had no other contact w/anybody who had the chickenpox;29JUN96 pt was dx as having full blown chickenpox;pt had 12 pox on the face & to many to count on chest;
Injection site was very sore and raised for 2 days. Then that subsided. Two days after that, the site started to itch, got lumpy again, and was very red - 2 inches in diameter. This lasted for a week. Everything finally subsided 13 days after the injection.
patient had a syncopal episode/it looked like her daughter was having a seizure/the patients legs were rigid; This spontaneous report was received from a consumer via sales representative referring to her daughter, an 11 years old Child patient. The patient's current condition, concomitant medication, medical history and historical drugs were unknown.   On 10-JUL-2019, the patient was vaccinated with HPV rL1 6 11 16 18 31 33 45 52 58 VLP vaccine (yeast)(GARDASIL 9)(strength, dose, lot number, expiry date, frequency unknown) via intramuscular route for vaccination (prophylaxis). Co-suspect included unknown vaccine which was administered prior to the HPV rL1 6 11 16 18 31 33 45 52 58 VLP vaccine (yeast)(GARDASIL 9) dose during the same office visit.   On 10-JUL-2019, the patient experienced syncopal episode, and the consumer reported it looked like her daughter was having seizure as she also noted her legs were rigid (seizure). The patient sought medical attention but no treatment was provided for the events. It was unknown whether lab diagnostics/studies were performed. The event was resolved on an unknown date in July 2019. The reporter's causality assessment between the event and the suspect therapy was unknown. There was no product quality complaint(PQC).  Upon internal review, the events seizures was determined to be medically significant.
mono valent dose given instead of the bi-valent....since the box and vial look the same
Respiratory difficulty started 3-4  four hours after 2nd shot, March 12, 2021  Lot # 032M20A -  it was very distressing Respiratory difficulty continued for about 6 months easing very slowly but I still feel it when I exercise.  Coughing began and continued for about 6 months, and then in March 2022, during Pollen season I started coughing again. I never had that during pollen season before.  Congestion began & continued for 6 months and then in March 2022 during Pollen season I had chest and nasal congestion. I have never had this before during pollen season.  *** Importantly -- it is unknown if the asthma I developed after the Moderna vaccine will be a permanent condition. We don't know yet.
Pain, swelling, redness persistent three days after the injection, fever of 101 approximately 24 hours after injection, joint pain, muscle pain, fatigue.
Had shoulder pain and soreness the day after injection, which continued. He saw provider on 3/28 for continued pain and was diagnosed with rotator cuff tendonitis. Will do ibuprofen, ice, heat and home care and if pain continues may have cortisone injection.
Systemic: Fainting / Unresponsive-Mild, Additional Details: patient fainted after administration. was recovered after 20 minutes of rest
PATIENT FELT SICK THE NIGHT OF 10/4/18 THEN ON 10/6/18 ARM BECAME RED AND WARM BELOW THE INJECTION SITES.
24 hours after my second vaccine I started to get an ocular migraine which quickly progressed to speech slurring, numbness in right arm and left hand and confusion. I was unable to speak. I regained my vision the next afternoon after taking Butalbital every 4 hours. That next day I started my period despite being on birth control and taking my pill regularly. I had two other ocular migraines in the next 7 days.
got shingles from the shingles vaccine/suspected vaccination failure; shingles; This case was reported by a consumer via interactive digital media and described the occurrence of suspected 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, unknown after receiving Shingles vaccine, the patient experienced vaccination failure (serious criteria GSK medically significant) and shingles. On an unknown date, the outcome of the vaccination failure and shingles were unknown.   The reporter considered the vaccination failure and shingles to be related to Shingles vaccine.  Additional details were provided as follows: The case was reported by patient's friend. The age at vaccination was not reported. The reporter reported that the patient got shingles from shingles vaccine. The follow-up could not be possible as no contact details were available.  This case was considered as suspected vaccination failure as details regarding the completion of primary vaccination schedule, time to onset and laboratory test confirmation for shingles were unknown at the time of reporting.
PTSD activation with very severe depression, very severe anxiety, moderate paranoia, suicidal thoughts, visual hallucination on morning after shot. Pain at injection site, moderate pain in all major muscles and joints, nausea, constipation, diaphoresis, weakness, exhaustion..
This spontaneous case was reported by a consumer and describes the occurrence of PARAESTHESIA (shooting tingling in her right arm/shooting tingling in her neck/shooting tingling into her shoulder blades/shooting tingling into her back/shooting tingling into her spine) and NERVE INJURY (She thought it was nerve damage) in an 86-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. Concurrent medical conditions included Fibromyalgia and Arthritis. On 02-Jul-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 05-Aug-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 04-Jul-2021, the patient experienced PARAESTHESIA (shooting tingling in her right arm/shooting tingling in her neck/shooting tingling into her shoulder blades/shooting tingling into her back/shooting tingling into her spine) and NERVE INJURY (She thought it was nerve damage). At the time of the report, PARAESTHESIA (shooting tingling in her right arm/shooting tingling in her neck/shooting tingling into her shoulder blades/shooting tingling into her back/shooting tingling into her spine) and NERVE INJURY (She thought it was nerve damage) outcome was unknown. No relevant concomitant medications were reported. Treatment medication was not provided by the reporter.
Seizures, seizure meds. 12/3 and 12/10/2009 PCP records from 11/2008-10/2009 and ED record for 11/8/2009. Patient with c/o's tonic-clonic seizure activity, with postictal headache, lethargy and confusion. Patient has a hx of seizure d/o since 4/2009, has been taking Keppra, Keppra dosage increased and Lamictal added
Systemic: Fainting / Unresponsive-Severe, Additional Details: Patient stood from seat during his 15 minute waiting period. Syncope occurred within 5 minutes. Patient fell face first on to floor and hit shelves with left arm. Loss of consciousness for approximately 2 minutes. Lost both 2 front teeth. Bleeding from mouth and left arm laceration. Patient was escorted Hospital via ambulance upon their arrival. Patient did not recall passing out.
Large area of discoloration from injection site to the elbow.  No treatment recommended by pcp.
I received my fourth vaccine shot in my right arm and the flu vaccine in my left arm. My fiancé and I went to dinner. Each of us had approximately three drinks (which is not unusual). As was true with the three previous doses, I felt feverish within a few hours, but instead of a slow progression, I lost consciousness by 10 pm. I was totally unresponsive for approximately one hour, although I was breathing. My fiancé considered taking me to the emergency room but decided against it after he was able to drag me inside our home. When I woke up, my mouth and lips were extremely itchy and puffy and I was still feverish. The fever broke approximately 36 hours after the shot. I have mostly recovered now.
1 hour post nasal spray developed headache, pallor, mild fever and night time hallucinations. This lasted 2 days. Was tx'd with TYLENOL.
This spontaneous report as received from a physician refers to a 14 year old male patient with none medical history. On an unspecified date in 2014 about 4-6 weeks ago the patient was vaccinated with dose 1 of GARDASIL (lot# was not reported). There was none concomitant medication. The patient began to vomit and became light headed and pale. The patient had been administered an unspecified meningococcal vaccine (manufacturer unknown) a few minutes before GARDASIL was administered. The patient sought medical attention in the office. No treatment was given for the adverse event. No lab diagnosis study was performed. The patient recovered the same day that GARDASIL was administered. The physician reported that the patient may not continue with the GARDASIL series. The physician reported that the patient had not consumed an adequate amount of fluids before receiving GARDASIL vaccination. Additional information has been requested.
pt recvd vax;to sleep @ noc,woke up grouchy;cry & tense up;not sleeping well;poor appetite;site puffy & red;fever inc to 102;mom stated pt usually easy going; to MD;mom said MD wants pt to have DT instead of DTP;
Covid Arm, Swollen Lymph nodes in neck, under arms and behind knees.  After first vaccine, I went to emergency room to have lump behind knee checked - it was lymphacitis.  I then went to an endocrinologist and had adrenals checked and. he said to wait a bit before getting next vaccine.  After 2nd dose, I was sick for over 4 days with 104 fever.  Very sick and adrenals swelled up bigger than last time.  I went to emergency room after 6 weeks of lump behind knee and they found a blood clot behind knee.  I am getting an ultrasound from vascular surgeon on June 30.
Acute episode 11/4/21-11/5/21 (18-24 hours): sudden onset of dizziness, confusion, involuntary tearfulness/crying, lost taste/smell, tinnitus  Chronic symptoms since 11/4/21: tinnitus, hearing sensitivity, dizziness  New symptoms since 11/24/21: heart palpitations, elevated blood pressure
Varicella vaccine-strain viral disease consisting of fever (100.6F - 104F reported per mother but none in office), fussiness, and rash (macules, papules, and vesicles overlying erythema). Began on 10/4/21 and rash began 10/5/21
Pt recvd dose Engerix-B 29JUN90 & seen in ER 03JUL90 w/ aching legs & swollen joints.Rx Lasix;01AUG90 recvd another dose vax & sx recurred;MD dx reflex sympath dystrophy.Vax dc'd.
Since getting the shot in September of 2017, I continue to experience muscular pain in the muscle of my upper left arm when moving it. I do not have free movement, it is stiff and requires more effort to move it and when I do so, it is very painful.
This spontaneous report was received from a consumer regarding her brother (patient) of unknown age. Approximately on an unknown date in 2008 (also reported as about 5 to 6 years ago) the patient was vaccinated with ZOSTAVAX (dosing regimen unspecified). Approximately on an unknown date in 2014 (also reported as now he has shingles) the patient experienced shingles. In addition, the reporter stated that she had also received ZOSTAVAX, but she does not know if she has had shingles before receiving ZOSTAVAX. There was no product quality complaint (PQC) involved. The outcome of shingles was unknown. Causality assessment was not provided. Additional information has been requested.
left arm soreness at the site of the injection; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE PAIN (left arm soreness at the site of the injection) in a 79-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     Concomitant products included METOPROLOL for an unknown indication.    On 07-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 07-Mar-2021, the patient experienced VACCINATION SITE PAIN (left arm soreness at the site of the injection). At the time of the report, VACCINATION SITE PAIN (left arm soreness at the site of the injection) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Treatment Medications were not provided by the reporter.   Reporter did not allow further contact; Sender's Comments:  MOD-2021-060900:husband case
cyst then ruptured into patient's lung; sore throat; birth control implant; put on a birth control pill; POTS; cyst in the back of their throat; This spontaneous report was received from a nurse via a company staff referring to an approximately 13-year-old female patient. The patient's medical history, historical drugs, past drug reactions or allergies, concurrent conditions, and concomitant drugs were unknown.   On an unknown date in 2019 (also reported as "at age 13"), the patient completed the vaccination of HPV rL1 6 11 16 18 31 33 45 52 58 VLP vaccine (yeast) (GARDASIL 9) injection (strength, dose, route of administration, lot#, and expiration date were not reported) for prophylaxis.  On an unknown date (reported as "shortly after"), the patient developed a sore throat that persisted on and off for about a year. Since an unknown date in 2020 (reported as "the following year"), the patient developed a cyst in the back of their throat (tonsillar cyst). On an unknown date, the cyst then ruptured into patient's lung and was hospitalized for 4 days. On an unknown date in 2022 (reported as "one year ago"), the patient started struggling standing up, experiencing dizziness and at times passing out. On an unknown date in March 2023 (reported as "6 months ago"), the patient was diagnosed with postural tachycardia syndrome (POTS) and was put on a birth control pill (oral contraception) as well as a birth control implant (contraceptive implant). It was unknown if the patient sought medical attention or treatment was given. The outcome of the events above was not reported.  The causal relationship between the events above and HPV rL1 6 11 16 18 31 33 45 52 58 VLP vaccine (yeast) (GARDASIL 9) was unknown.
Pt reported feeling light-headed after 15 minute monitoring period post vaccine. BP 146/94 Left arm. Pulse 68, regular rhythm. SpO2=99 Offered water to drink and continuing monitoring period with pt sitting in recliner. Pt has spouse able to drive her home when ready. Pt reports no known allergies. 1743: BP 144/92, pulse 77, regular rhythm. Resp rate 14, SpO2=100 1755: BP 139/87 (101), Pulse 64, regular rhythm, Resp rate = 16, SpO2=100. 1800: Pt stood without any dizziness, steady gait. Pt reports no further light-headedness and feels comfortable leaving monitoring area. Instructed pt to call EMS with any concerning symptoms once at home. Husband will drive pt home.
Tongue became rigid and stiff, so hung out of mouth for periods of 20 minutes to 1 1/2 hours 4 times over the course of a week.