chrisvoncsefalvay/vaers-outcomes huggingface dataset:
I have existing peptic ulcer and acid reflux I have been dealing with for years. I also have elevated cholesterol level for which I am being treated. Within 24 hours of receiving the first dose of the Moderna vaccine, the pain from my peptic ulcer went from 2 to 10 on a scale of 10. It became so severe that I could not sit at work. I had to leave work and went back home. Then on January 13, 2021, I started noticing a back pain that radiates throughout my left back side. On January 15, 2021, I went to the ER because the pain was so severe that I could not not lie down, sit, or breath. I was diagnosed with pleurisy (inflammation of the lung linings). The X-ray also showed enlarged heart but the ER doctor said my heart is fine. They also performed EKG on me. I did not mention receiving the vaccine to the ER doctor because I never thought the vaccine could result in such side effects. I did not mention it to my PCP also because I believe the vaccine is safe. But recently I went through the sequence of events myself and the only thing that happened regarding my health was the vaccine. Nothing else. After vaccination, I went to ER on Jan 15, 2021 at around 11:30PM due to severe back pain and was diagnosed with pleurisy through X-ray. My X-ray also showed an enlarged heart but I suspect that was due to the fact that I could not breath properly when the x-ray was taken. I will repeat the X-ray in a couple of weeks. Never experienced pleurisy or heart enlargement in my life prior to the vaccine. Not sure the vaccine was responsible but the coincidence is suspicious.
Re: Janssen COVID-19 Vaccine EUA  Received vaccine at about 10:21am. Developed possible adverse effects at about 4:00pm. Initially I noticed weakness and feeling "out of it". I was grocery-shopping at the time, and pushing the cart, standing upright, etc. was becoming difficult. Sometime between 4:00pm and 5:00pm I became delirious and also was no longer able to stand or sit upright. In my altered state I believed that my muscles, especially those in my legs, were turning into goo and then turning into normal muscles again. I experienced fever dreams. I had hot flashes and chills. I had the worst pain that I have experienced in recent memory.  I think that I may have had a migraine episode in addition to, and triggered by, these experiences. I had nausea (no vomiting).  Most of these events lasted until about between 12:30am to 1:00am, which was when I fell asleep. When I woke up the following morning (today as I am reporting), I still had a mild headache and exhaustion but the other events had resolved.
Her sister, had the Pfizer Covid vaccine, and she hadringing in her ears; This is a spontaneous report received from non-contactable reporter(s) (Consumer or other non HCP).  A female patient received bnt162b2 (BNT162B2) (Batch/Lot number: unknown) as 1st dose, single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: TINNITUS (non-serious) with onset 26Feb2021, outcome "unknown", described as "Her sister, had the Pfizer Covid vaccine, and she hadringing in her ears".
w/in 12hr of vax pt devel an inj site rxn characterized by redness, swelling & itching;pt was seen by MD & treated w/allegra;
Significant pain in left arm approx. 1.5 hours post-vaccine. Felt a little under the weather the rest of the day yesterday, then started feeling very sick in the middle of the night at approx. 1:30 a.m. Flu like symptoms ever since then, with severe headache and body aches and pains. I have been taking max doses of ibuprofen and acetaminophen all day.
Information has been received from a certified medical assistant concerning a 25 year old female with no known allergies and no pertinent medical history, who on 01-OCT-2007, was vaccinated with Gardasil vaccine. Concomitant therapy included unspecified birth control. On 01-OCT-2007, the patient received her first dose of Gardasil vaccine and fainted. The patient felt sweaty and then her eyes rolled back and she passed out. The patient was in the office at the time of the event. No labs or diagnostic studies were performed. On 01-OCT-2007, the patient recovered from fainting but when she left the office she felt a little shaky and achy. No other information was reported. Additional information is not expected.
My arm became very swollen, red, and stung several hours after receiving the vaccination. I have never had a reaction to a shot, so this concerned me. The next morning (this morning) I woke feeling icky and slightly feverish. Symptoms increased, and by 1pm, I decided to take an Ibuprofen tablet. By 6pm, my arm was bothering me more, I showed it to my husband, who said it not only looked worse, but was bright red. As it was too late to go to the Dr., so at 6:30, we went to an urgent care facility to check it out. NP told me it was an adverse reaction to the vaccination.
Aching body (After the Second Dose); Fever 101 F (After the Second Dose); lightheaded (After the Second Dose); This spontaneous case was reported by a consumer and describes the occurrence of MYALGIA (Aching body (After the Second Dose)), PYREXIA (Fever 101 F (After the Second Dose)) and DIZZINESS (lightheaded (After the Second Dose)) in a 71-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 028A21A) for COVID-19 vaccination.     The patient's past medical history included No adverse event (no historical condition reported).   On 14-Apr-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 15-Apr-2021, the patient experienced MYALGIA (Aching body (After the Second Dose)), PYREXIA (Fever 101 F (After the Second Dose)) and DIZZINESS (lightheaded (After the Second Dose)). At the time of the report, MYALGIA (Aching body (After the Second Dose)), PYREXIA (Fever 101 F (After the Second Dose)) and DIZZINESS (lightheaded (After the Second Dose)) outcome was unknown. Not Provided          no concomitant medication reported. treatment medication includes Tylenol for fever.
dry mouth; thick tongue; difficulty shallowing; This spontaneous case was reported by a patient and describes the occurrence of DRY MOUTH (dry mouth), TONGUE DISORDER (thick tongue) and DYSPHAGIA (difficulty shallowing) in a 50-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 030m20a) for COVID-19 vaccination.     Concomitant products included CARVEDILOL (CARVEDIOL) for an unknown indication.    On 02-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 02-Mar-2021, the patient experienced DRY MOUTH (dry mouth), TONGUE DISORDER (thick tongue) and DYSPHAGIA (difficulty shallowing). On 02-Mar-2021, DRY MOUTH (dry mouth), TONGUE DISORDER (thick tongue) and DYSPHAGIA (difficulty shallowing) had resolved. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       treatment to the events are reported as Sudafed.
Right eye was reddish; Right eye was very swollen; Rash on her left side; This spontaneous case was reported by a consumer and describes the occurrence of OCULAR HYPERAEMIA (Right eye was reddish), EYE SWELLING (Right eye was very swollen) and RASH (Rash on her left side) in a 64-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 011F21A) for COVID-19 vaccination.     No Medical History information was reported.    On 16-Oct-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. In October 2021, the patient experienced OCULAR HYPERAEMIA (Right eye was reddish), EYE SWELLING (Right eye was very swollen) and RASH (Rash on her left side). The patient was treated with CORTISONE for Rash, at an unspecified dose and frequency. At the time of the report, OCULAR HYPERAEMIA (Right eye was reddish), EYE SWELLING (Right eye was very swollen) and RASH (Rash on her left side) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No concomitant medications were provided. 7 days later, patient right eye was reddish and was very swollen; patient had to seek medical attention and see an eye specialist. Patient has never seen an eye doctor or eye specialist before. Patient also developed rash on her left side about a week ago. She will eventually go to the medical facility. Patient was using cortisone cream for 7 days.  Company comment- This case concerns a 64-year-old, female patient with no medical history, who experienced the unexpected non serious events of ocular hyperemia and eye swelling and expected non serious event of rash. The events occurred approximately 7 day after the first dose of mRNA-1273. The patient's right eye was reddish and was very swollen; patient had to seek medical attention and see an eye specialist. Patient has never seen an eye doctor or eye specialist before and will eventually go to the medical facility. Patient also developed rash on her left side. The rechallenge was not applicable, as event outcome was unknown and no information regarding second dose was provided. The benefit-risk relationship of mRNA-1273 is not affected by this report.; Sender's Comments: This case concerns a 64-year-old, female patient with no medical history, who experienced the unexpected non serious events of ocular hyperemia and eye swelling and expected non serious event of rash. The events occurred approximately 7 day after the first dose of mRNA-1273. The patient's right eye was reddish and was very swollen; patient had to seek medical attention and see an eye specialist. Patient has never seen an eye doctor or eye specialist before and will eventually go to the medical facility. Patient also developed rash on her left side. The rechallenge was not applicable, as event outcome was unknown and no information regarding second dose was provided. The benefit-risk relationship of mRNA-1273 is not affected by this report.
This case was reported by a healthcare professional and described the occurrence of injection site redness in a 30-year-old female subject who was vaccinated with BOOSTRIX (GlaxoSmithKline).  Concurrent medical conditions included allergy to amoxicillin.  There were no concurrent medications.  On 5 April 2010 at 08:15 the subject received unspecified dose of BOOSTRIX at 0.5 ml in the left arm.  On 5 April 2010, less than one day after vaccination with BOOSTRIX, the subject experienced injection site redness and injection site pruritus.  The subject was treated with Benadryl.  At the time of reporting the events were improved.
Itching in her throat and feels like her tonsils are swelling and hard to swallow.  SPO2 @ 100% RA. Zyrtec 10 mg given PO @ 9:17 am per Dr. 0931 -D/C & Released per Dr, pt no s/s of distress, able to speak in full sentences.
chills; flu like symptoms; This case was reported by a consumer and described the occurrence of chills in a 63-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   Co-suspect products included Flu Seasonal QIV Dresden (Influenza vaccine Quadrivalent 2020-2021 season) for prophylaxis.   In November 2020, the patient received the 1st dose of Shingrix and Influenza vaccine Quadrivalent 2020-2021 season. On an unknown date, less than 2 months after receiving Shingrix and Influenza vaccine Quadrivalent 2020-2021 season, the patient experienced chills and influenza-like symptoms. On an unknown date, the outcome of the chills and influenza-like symptoms were recovered/resolved.   It was unknown if the reporter considered the chills and influenza-like symptoms to be related to Shingrix and Influenza vaccine Quadrivalent 2020-2021 season.  Additional information was provided as follows: The patient received 1st dose of Shingrixin left arm and a dose of Flu vaccine in right arm. The patient experienced chills and flu like symptoms which resolved in 1 day. The reporter consented to follow up. For the tolerance of 2nd dose, refer case- US2021AMR008962, reported by the same reporter. The case is linked with the case number- US2021008406, reported by the same reporter.; Sender's Comments:  US-GLAXOSMITHKLINE-US2021008406:same reporter US-GLAXOSMITHKLINE-US2021AMR008962:same reporter, same product, different dose
the patient had itching all over her body; Injection Site Bruising; This case was reported by a pharmacist via call center representative and described the occurrence of generalized pruritus in a 84-year-old female patient who received Herpes zoster (Shingrix) (batch number F4234, expiry date 30th April 2022) for prophylaxis.   Previously administered products included Shingrix with an associated reaction of pain (1st dose received on an unknown date, refer case US2020191521) and Coumadin (had a history of taking Coumadin).   On 3rd September 2020, the patient received the 2nd dose of Shingrix. In September 2020, 3 days after receiving Shingrix, the patient experienced generalized pruritus and injection site bruising. On an unknown date, the outcome of the generalized pruritus and injection site bruising were not recovered/not resolved.   It was unknown if the reporter considered the generalized pruritus and injection site bruising to be related to Shingrix.  Additional details were reported as follows: The patient experienced itching and injection site bruising 3-4 days after receiving 2nd dose of Shingrix. The physician described itching as the patient itching all over her body. On 23rd September 2020, the patient had an appointment with her physician, results of appointment were unknown.; Sender's Comments:  US-GLAXOSMITHKLINE-US2020191521:Same reporter
Client received Zostavax in am on 05/14/2009.  The visit was uneventful.  On 05/15/2009 she came back to the HD stating her r. lower arm was sore.  She had a reddened area approx.2 inches in diameter, warm to touch and slightly swollen.  PHN told her to use ice on area 3-4 times/ day; use Ibuprofen 1 every 4-6 hours and take Benadryl 1 @ hs.  Do this until 05/18/2009.  If it hasn't improved by then, call her Dr.  If it worsens, call her Dr. or go to ER.  PHN called her back on 05/18/2009.  She said area has improved immensely.  Recommend she continue treatment until the small reddened area (now size of a dime) disappears.
Pt reports having sore arm 1 hours after immunization. Subsequently developed fever, HA, fatigue, and nausea at night and the following day. Patient reports symptoms to the clinic 2 days later, states symptoms are improving but still lingering.
A spontaneous report was received from female patient of unspecified age who received Moderna's COVID-19 vaccine (mRNA-1273) and experienced events redness at the injection site, swelling at the injection site, warm to the touch at the injection site.  The patient's medical history was not provided. Concomitant medications included for High blood pressure, Esomeprazole  as antacid, Atorvastatin for cholesterol .   On 2 Feb 2021, prior to the onset of the events the patient received first of two planned doses of mRNA-1273 (Batch number: 023L20A) via unknown route for prophylaxis of COVID-19 infection.  After receiving the vaccine, the patient experienced the events redness at the injection site, swelling at the injection site, warm to the touch the injection site.  Treatment details included acetaminophen.  Action taken with mRNA-1273 in response to the events were unknown.  The outcome of events redness at the injection site, swelling at the injection site, warm to the touch at the injection site was unknown.
Headache, Myalgia, Fever, tender lymph nodes, ringing in rt ear, chills/sweats Narrative:  Other Relevant History:
Leukopenia, Abd pain, F 103, decreased appetite Admit 5/17 0500 D/C 5/18. 5/17 ALT 185, Amylase 1035, lipase 1924, AST 417, WBC 2.6, N24%, L61%. 5/18 Lipase 24, Amylase 96, LDH 300, WBC 4.4, Hgb 10.7, Uric acid 3.5, B12/Folat normal, Retic % 0.45, CRP 5.1, IV fluids. 6/9/08-records received for DOS 5/17-5/18/08-DX: Pancreatitis. Increased amylase and lipase liver function tests. Leukopenic.Presented with 1 day history of abdominal pain, screaming. Fever of 102.2 (R), lethargic. Loose stools no blood. Seen for strep throat day prior which was negative.
Knot at injection site, next morning had red circle about 1 1/2" in diameter around injection site, woke with muscle and joint pains, hurt all over.
vaccine-associated atrial fibrillation; This serious case was reported in a literature article and described the occurrence of atrial fibrillation in a patient who received DTPa (Diphtheria tetanus acellular pertussis) for prophylaxis.  On an unknown date, the patient received Diphtheria tetanus acellular pertussis. On an unknown date, an unknown time after receiving Diphtheria tetanus acellular pertussis, the patient experienced atrial fibrillation (Verbatim: vaccine-associated atrial fibrillation) (serious criteria GSK medically significant). The outcome of the atrial fibrillation was not reported.   The reporter considered the atrial fibrillation to be related to Diphtheria tetanus acellular pertussis.    The company considered the atrial fibrillation to be related to Diphtheria tetanus acellular pertussis.   Additional Information: GSK Receipt Date: 27-MAR-2023 This case refers to the patient from age group 0-17 years who received DTPa vaccine and had atrial fibrillation. The patient was a part of study which aimed to shed the light on the reported incidence of atrial fibrillation (AF) with different widely used vaccines. The Vaccine Adverse Event Reporting System (VAERS) was used between 1990 and 2021 to search for AF. In this study, the comprehensive evaluation of the incidence of AF in association with all vaccines (COVID, zoster, influenza, pneumococcal, hepatitis B, tetanus, diphtheria, and pertussis (TDAP), tetanus and diphtheria (TD), tetanus toxoid (TTOX), smallpox, anthrax, typhoid, meningococcal, hepatitis A, Lyme, measles, mumps, rubella (MMR), yellow fever, human papillomavirus (HPV), Japanese encephalitis virus, poliovirus, and varicella) was done. The association between the use of vaccines with arrhythmia adverse events was assessed by disproportionality signal detection analysis using the reporting odds ratio (ROR). Total 2341 cases of AF were reported. The patient received tetanus, diphtheria an acellular pertussis vaccine and experienced Vaccine-associated atrial fibrillation.; Sender's Comments:  US-GSK-US2023GSK048793:Same author US-GSK-US2023GSK048858:Same author
patient developed a red, swollen and warm arm from the mid deltoid down to the elbow in the left arm starting the day after receiving the vaccine.  She eventually saw a doctor and they recommended she take benadryl which she has started yesterday 9/9 and it has been improving since.
Erythema at injection site greater than 5 cm. The area was about 4 inches in diameter, red, and warm on 10/2/2013.
under 18 years; This spontaneous case was reported by a nurse and describes the occurrence of PRODUCT ADMINISTERED TO PATIENT OF INAPPROPRIATE AGE (under 18 years) in a 14-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 009C21A) for COVID-19 vaccination.     No Medical History information was reported.    On 14-Jul-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 14-Jul-2021, the patient experienced PRODUCT ADMINISTERED TO PATIENT OF INAPPROPRIATE AGE (under 18 years). On 14-Jul-2021, PRODUCT ADMINISTERED TO PATIENT OF INAPPROPRIATE AGE (under 18 years) had resolved.        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 provided.  No treatment information provided.   This case was linked to MOD-2021-272958 (Patient Link).
developed cirrhosis; scalp infection; Headache; A spontaneous report was received from a consumer concerning a female patient who received Moderna's COVID-19 vaccine (mRNA-1273) and developed cirrhosis, scalp infection and headache.    The patient's medical history was not provided. Concomitant product use was not provided by the reporter.   On unknown date, prior to the onset of the symptoms, the patient received their first of two planned doses of mRNA-1273 (Batch number not provided) intramuscularly for prophylaxis of COVID-19 infection.   On unknown date, the patient who developed cirrhosis and scalp infection. Treatment information was not provided.    Action taken with mRNA-1273 in response to the events was not provided.  The outcome of the events who developed cirrhosis, scalp infection and headache was unknown.; Reporter's Comments: Very limited information regarding the events of cirrhosis and scalp infection have been provided at this time.  Further information has been requested.
Redness noted around injection site. Parent messaged doctor and sent picture. Treatment with ice and to return to office if it does not improve in 1-2 days
Within 40 minutes of injection, felt dazed and intoxicated as if on painkillers; Within 40 minutes of injection, felt dazed and intoxicated as if on painkillers; Vision blurred; Body grew heavy feeling; Cclumsiness of movement; This is a spontaneous report received from a contactable Other Health Care Professional. A 46-years-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: Solution for injection, Lot Number; EL9262 and Expiration Date was not reported) via an unspeci-fied route of administration in Arm Left on 21Jan2021 15:00, as 1st dose, single for COVID-19 immunization. Medical history included hypothyroidism, diverticulum, asthma all from an unknown date and unknown if ongoing. Concomitant medication(s) included liothyronine sodium (CYTO-MEL); levothyroxine sodium (SYNTHROID); ethinylestradiol, norgestimate (ORTHO TRI-CYCLEN LO) all taken for an unspecified indication, start and stop date were not reported.  Prior to vaccination, the patient was not diagnosed with COVID-19 and did not receive any other vaccines within 4 weeks prior to the COVID vaccine. It was reported that Within 40 minutes of injection, felt dazed and intoxicated as if on painkillers, vision blurred, body grew heavy feeling, clumsiness of movement. No treatment received for the adverse event. Since the vaccination, the patient has not been tested for COVID-19. The outcome of the events was recovered on an unspecified date.  Follow-up attempts are completed. No further information is expected.
Employee received the first dose of the Pfizer COVID vaccine on 1/26/21.  Four days later, on 1/30/21, developed hear palpitations during a work shift (occupational therapist). Heart palpitations were frequent and constant (multiple every minute).  This reaction lasted for almost 6 days, with reportedly no break in the frequency of the palpitations.  She presented to emergency department on 1/31/21, was tested and monitored for 3.5 hours and was found to have frequent PVCs. She was discharged and continued to experience PVCs until Friday 2/5/21. She followed up with outpatient cardiology and wore a 24hr Holter monitor, further diagnosis unknown by this reporter.  Employee states she has never experienced continuous palpitations and does not report any other habit changes during  this time.
Diarrhea which became watery every 10 to 15 minutes. Lasted until 12:00 A.M. No further effects. No additional complaints.
Red, swollen, hot arm 10x12.5 cm (still present),  fever to 101.7 24 hrs after shot resolved 72 hrs later, muscles aches and headache 48hrs, inflamed tongue with lesion on tip appeared  72 hrs later (still present).
Rash and Hives appeared on left arm and neck within approximately 3 minutes of receiving the vaccine. 25mg oral diphenhydramine given approximately 14 minutes after receiving the vaccine. Patient was monitored by healthcare professionals; rash and hives resolved within approximately 45 minutes.