chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Tinnitus; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 46 year-old male patient received bnt162b2 (BNT162B2), administered in arm left, administration date 03Mar2021 15:00 (Lot number: EN6202) at the age of 46 years as dose 1, single for covid-19 immunisation. Relevant medical history included: "Known allergies: Rare Tuna" (unspecified if ongoing); "hypertension" (unspecified if ongoing); "high cholesteryl" (unspecified if ongoing); "High trigs" (unspecified if ongoing); "Hiatal Hernia" (unspecified if ongoing). Concomitant medication(s) included: NIASPAN; NORVASC; LISINOPRIL; VASCEPA; CRESTOR; NE [TOCOPHEROL]. The following information was reported: TINNITUS (non-serious) with onset 04Mar2021 03:00, outcome "not recovered", described as "Tinnitus". The event "tinnitus" was evaluated at the physician office visit. Relevant laboratory tests and procedures are available in the appropriate section. Therapeutic measures were taken as a result of tinnitus.  Additional info: Patient stated, I did receive my second injection on 24Mar, and it got a bit worse. I saw ENT. I did take 12 days of prednisone which helped, but once I stopped the ringing returned. The most recent COVID-19 vaccine was administered at Pharmacy or Drug Store. Patient was not diagnosed with COVID-19, Prior to vaccination.  No follow-up attempts are possible. No further information is expected.
Stabbing headache pain, chills followed by high temperature of 102.8 and body ache
Patient notified medical office today 3/5/2020 about arm red around injection site. Provider FNP looked at patient's arm.  Left arm warm to the touch, swollen and red.
no fever, but pain from the shoulder joint to wrist of the arm the inj. was given. difficult to lift coffee cup the next morning. pain is a 7 on a scale of 1-10 when moved a 2 when at rest. have never had this pain before from other td inj. will rest it, due to no ins, and i know it will pass.
Day 1 - fever and body aches, Day 2 -  shakes, lost sense of taste, weak and body aches
Four days after immunization  onset of arthropathy in left fifth toe (red, pain, edema) progressed on  seventh day with enthesitis /Swelling left medial malleolus.  Day 12 progressed to tender, swelling Achilles? tendon left side, day  14 stiff great toe and foot edema. Difficulty ambulating on left foot.  Prednisone prescribed but not started to this point.  This flare similar to IBD arthropathy in past but have been in remission until vaccinated.
02/22/2023 I had a horrible stomach ache I went to the ER and they removed my gallbladder the same night. I was admitted for 4 days. I have fully recovered.
Mom states child didn't act right.  Layed around.  No appetite for 2 days.  States called someone (no record).  Wouldn't let anyone else give immunization.
site pain and minor swelling; site pain and minor swelling; This spontaneous report was received from a licensed practical nurse and refers to a 13-year-old female patient. There was no information about the patient's concurrent conditions, concomitant therapies or medical history provided.  On 15-APR-2019, the patient was vaccinated with the first dose of hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast) (GARDASIL 9) lot # R003557 has been verified to be a valid lot number, expiration date not reported, but upon internal validation established as 20-NOV-2020 in the right deltoid (exact dose and route of administration were not reported).  On an unknown date in 2019, the patient experienced site pain and minor swelling. The outcome of the events was unknown. The relatedness between the event and hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast) (GARDASIL 9) was not reported.      This is one of two reports received from the same reporter.; Sender's Comments:  US-009507513-1712USA007049:
no antibodies post second dose; This spontaneous case was reported by a consumer and describes the occurrence of SARS-COV-2 ANTIBODY TEST NEGATIVE (no antibodies post second dose) in a male patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No medical history was provided by the reporter.    On an unknown date, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On an unknown date, the patient experienced SARS-COV-2 ANTIBODY TEST NEGATIVE (no antibodies post second dose). At the time of the report, SARS-COV-2 ANTIBODY TEST NEGATIVE (no antibodies post second dose) outcome was unknown.            Concomitant product use was not provided by the reporter.  Action taken with mRNA-1273 in response to the events was not applicable.  Treatment information was not provided.
Atrial fibrillation; This is a spontaneous report from a contactable consumer (reporting for himself). A 36-year-old male patient received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: EN6204, expiration date: unknown), via an unspecified route of administration in left arm on 11Mar2021 at 12:00 as single dose for COVID-19 immunization. Medical history included gout. The patient's concomitant medications were not reported. On 12Mar2021 at 01:00, the patient experienced atrial fibrillation. The patient stated that it was his first time to have ever had any heart issues. The patient did not received treatment for the event. The outcome of the event was not recovered. The patient did not had COVID-19 prior to vaccination and was not tested post vaccination.
Dizziness, Headache, Sedation, Myalgia, Swollen lymph nodes, Chills, Pain of entire arm and  redness/rash with increased temperature to touch @ injection  site Narrative:
Moderna bivalent booster was given 1 day earlier than 4 day grace period allows from previous booster. Bivalent booster given 9/29/22; Previous booster given 8/4/22; No adverse event
needle disconnected from the syringe during administration; This spontaneous case was reported by a consumer and describes the occurrence of DEVICE CONNECTION ISSUE (needle disconnected from the syringe during administration) in a 50-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 002F21A) for COVID-19 vaccination.     No Medical History information was reported.    On 10-Aug-2021 at 5:15 PM, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 10-Aug-2021, the patient experienced DEVICE CONNECTION ISSUE (needle disconnected from the syringe during administration). At the time of the report, DEVICE CONNECTION ISSUE (needle disconnected from the syringe during administration) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No Concomitant medications were reported. No Treatment information was reported.
vials were stored in the refrigerator and thawed on same day of administration; Doses were administered after the expiration date; This spontaneous case was reported by an other health care professional and describes the occurrence of PRODUCT STORAGE ERROR (vials were stored in the refrigerator and thawed on same day of administration) and EXPIRED PRODUCT ADMINISTERED (Doses were administered after the expiration date) in a 60-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 066H21A) for COVID-19 vaccination.     No Medical History information was reported.    On 22-Apr-2022, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 22-Apr-2022, the patient experienced EXPIRED PRODUCT ADMINISTERED (Doses were administered after the expiration date). On an unknown date, the patient experienced PRODUCT STORAGE ERROR (vials were stored in the refrigerator and thawed on same day of administration). At the time of the report, PRODUCT STORAGE ERROR (vials were stored in the refrigerator and thawed on same day of administration) and EXPIRED PRODUCT ADMINISTERED (Doses were administered after the expiration date) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   Patient's weight was reported as 200.  Concomitant medications were not reported.  The patient had received booster 1. The patient had no known reactions. The vials were thawed on same day of administration. The vials did not undergo any temperature excursions.  Treatment information was not reported.
UTI after 1st dose; Dizziness; Nausea; Vomiting; Diarrhea; This non-serious case was reported by a consumer via call center representative and described the occurrence of urinary tract infection in a 62-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.  On 12-JAN-2023, the patient received the 1st dose of Shingrix (intramuscular, left arm) .5 ml. On 12-JAN-2023, immediately after receiving Shingrix, the patient experienced dizziness (Verbatim: Dizziness), nausea (Verbatim: Nausea), vomiting (Verbatim: Vomiting) and diarrhea (Verbatim: Diarrhea). In FEB-2023, the patient experienced urinary tract infection (Verbatim: UTI after 1st dose). The patient was treated with macrobid (nos) (Macrobid). The outcome of the urinary tract infection, dizziness, nausea, vomiting and diarrhea were resolved.  It was unknown if the reporter considered the urinary tract infection, dizziness, nausea, vomiting and diarrhea to be related to Shingrix.  It was unknown if the company considered the urinary tract infection, dizziness, nausea, vomiting and diarrhea to be related to Shingrix.  Linked case(s) involving the same patient: US2023AMR052324  Additional Information: GSK Receipt Date: 10-APR-2023 The case was self-reported by the patient. The patient had received the first dose of Shingrix into left arm and had immediately experienced nausea, vomiting, diarrhea and dizziness and urinary tract infection (UTI) one week to 10 days afterwards.  The reporter reported that her healthcare professional prescribed Macrobid for 5 days for both UTI's.  The patient reported that she had not experienced an UTI in over 10 years so she felt this be reported.  The reporter did not consent to follow up. 1 week after receiving Shingrix, the patient experienced urinary tract infection. For tolerance of second dose, kindly refer case US2023AMR052324 that was reported by same reporter.; Sender's Comments:  US-GSK-US2023AMR052324:Same reporter.
I was suspicious because I was quite healthy after vaccination. A month and half after the booster shot, my heart and head didn't feel right. My heart was beating fast and kind of trembling. In my head, it wasn't headache or dizziness, it was more of a sensation of two balls rubbing together in my head. My doctor gave me a blood test and it showed that the Synthroid levels were too high. I had the same dosage for the past 15-20 years. I had to have my dosage reduced. I was prescribed Propranolol 10 mg for my heart. I am still taking all the other medications that I was before plus baby aspirin.
RASH DEVELOPED AROUND 1 HOUR AFTER IMMUNIZATION.  PER GRANDMOTHER RASH STARTED AT SITE AREA AND JUST BELOW AND SPREAD UP PATIENT'S NECK.   RASH STILL PRESENT TODAY.
Cellulitis right deltoid diagnosed on 12/12/10 treated with CEFADROXIL 250 mg/5 ml 2 tsp BID X 7d.
Huge local reaction spanning entire upper arm, with redness & swelling. Fluid filled pustules forming on upper arm also.
received a half dose; This spontaneous case was reported by a pharmacist and describes the occurrence of ACCIDENTAL UNDERDOSE (received a half dose) in a 67-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 045J21A) for COVID-19 vaccination.     Concurrent medical conditions included Arthritis and Immunocompromised.    On 08-Dec-2021, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 08-Dec-2021, the patient experienced ACCIDENTAL UNDERDOSE (received a half dose). On 08-Dec-2021, ACCIDENTAL UNDERDOSE (received a half dose) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No relevant concomitant medications were reported. Treatment information was unknown.
Patient describes a large red, inflamed, painful area approximately the size of his hand around the injection site. Patient is taking ibuprofen/TYLENOL.
Fatigue, enlarged left breast and lymph nodes. Dizziness, had the feeling of blacking out, headache, muscle weakness, BP was stable 58-60 when patient sitting, spikes to 100 when she stands.
Swollen lymph nodes on the left side (which is the side he got his vaccine) and small bumps all around that area; Swollen lymph nodes on the left side (which is the side he got his vaccine) and small bumps all around that area; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) from medical information team.  A male patient received bnt162b2 (BNT162B2) (Batch/Lot number: unknown) as dose number unknown, single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: LYMPHADENOPATHY (non-serious), KERATOSIS PILARIS (non-serious), outcome "not recovered" and all described as "Swollen lymph nodes on the left side (which is the side he got his vaccine) and small bumps all around that area".  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
I had my vaccine on Saturday and on Monday my platlets were at 16. I was almost hospitalized but, after steroids they improved.
fatigue; temperature of 102F; headache; sore arm; This is a spontaneous report received from a contactable consumer, the patient. A 64-year-old non-pregnant female patient received first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot number: ENG198) via an unspecified route of administration in the left arm on 11Mar2021 at 11:00 (at the age of 64-years-old) as a single dose for COVID-19 immunisation. Medical history included breast cancer. The patient was allergic to erythromycin. The patient was diagnosed with COVID-19 prior to vaccination. The patient had not tested positive for COVID-19 since the vaccination. The patient did not receive any other vaccines within four weeks prior to the vaccination. Concomitant medications included beclomethasone (QVAR), montelukast (MANUFACTURER UNKNOWN), olmesartan medoxomil (MANUFACTURER UNKNOWN), anastrozole (MANUFACTURER UNKNOWN) all for unknown indications and from an unknown date and unknown if ongoing. On 11Mar2021 at 15:00, the patient experienced fatigue, temperature of 102F, headache and sore arm. Fever lasted 24 hours and started 8 hours after shot. Fatigue started a few hours after shot and was severe for 24 hours (could not get out of bed) and gradually went away over a week. The adverse events did not result in doctor or other healthcare professional office/clinic visit, and emergency room/department or urgent care. The patient did not receive treatment for the reported events. The clinical outcome of events fatigue, temperature of 102F, headache and sore arm was recovered on an unknown date in Mar2021. No follow up attempts are needed. No further information is expected.
Ringing in my beard srtednwithim an hour of vaccination.   Still prevalent 10 hrs.  later
Upper arm swelling, redness, heat, painful from below elbow to shoulder. Peaked 30 hours after vaccination and subsided on day four; upper arm still painful to the touch 7 days after vaccination but swelling and heat gone.
around 6PM 21OCT97 noticed arm getting sore;this morning arm very sore down to the elbow & up to shoulder joint;red area @ inj site about fifty cent in size & red blotches around area on forearm;
Initial burning and pain radiating to elbow and neck. Currently still having pain resulting in decreased range of motion and strength to left arm.
Stomach Pain; Gassiness; Diarrhea; A spontaneous report was received from a consumer who is a 68-year-old, female patient that received Moderna's COVID-19 vaccine (mRNA-1273) and experienced stomach pain, gassiness and diarrhea.   The patient's medical history was not provided. No relevant concomitant medications were reported.   On 29-Jan-2021 prior to the onset of the events, the patient received their first of two planned doses of mRNA-1273 (Lot number: 004M20A) intramuscularly in the left arm for prophylaxis of COVID-19 infection.     On 29-JAN-2021, the patient experienced stomach pain, gassiness and diarrhea.  Treatment for the events included Miralax.    Action taken with mRNA-1273 in response to the events was not reported.     The outcome of the events, stomach pain, gassiness and diarrhea, was considered as not resolved/not recovered.; Reporter's Comments: Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded.
Dad states child received Hepatitis A vaccine Friday 2/16/12. Saturday 2/17/12 broke out in rash between eyes on face, back and torso. Sunday 2/18 eyes puffy - father gave BENADRYL - eyes still puffy today & still has rash. No problems breathing. States throat hurts today. Referred to pediatrician.
History past year seeing doctor for complaint of colds, stuffed nose, post nasal drainage.  Prescribed high protein diet nose spray and now allergy shots.  Developed headache sometime in June almost every day - between eyes and at base of neck.  Ibuprofen helps.  Parents questions relation to vaccine and headache.
One day after vaccine had soreness at injection site, mild fever, chills, dizziness. Seen by administering clinic with not treatment given. One week later, weakness and hoarseness. Resolved with time. 2 weeks after injection developed face lesion subsequently diagnosed by dermatologist as discoid lupus - being treated topically.
weakness, joint pain, headache; weakness; joint pain; This is a spontaneous report from a contactable consumer or other non-hcp (Patient). A 76-year-old non-pregnant female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: solution for injection; Batch/Lot Number: Unknown, Expiration date: Unknown) via an unspecified route of administration (age at vaccination 76-year) on 09Mar2021 at 10:30 AM as dose number unknown, single for COVID-19 immunization. Medical history included known allergies: slight reaction to penicillin, COVID-19 (prior COVID vaccination), both from an unknown date and unknown if ongoing. There were no concomitant medications. The patient received no other vaccine in four weeks, and no other medications in two weeks. The patient not tested COVID post vaccination. On 10Mar2021 at 03:00 AM the patient experienced weakness, joint pain, headache. The patient received no treatment for the adverse events. The clinical outcome of the events was not resolved.  No follow-up attempts are possible; information about lot/batch number cannot be obtained.
hair loss; This case was reported by a consumer via call center representative and described the occurrence of accelerated hair loss in a adult patient who received Herpes zoster (Shingrix) for prophylaxis.   On an unknown date, the patient received the 1st dose of Shingrix. On an unknown date, unknown after receiving Shingrix, the patient experienced accelerated hair loss. On an unknown date, the outcome of the accelerated hair loss was unknown.   It was unknown if the reporter considered the accelerated hair loss to be related to Shingrix.  Additional details were provided as follows: The age at vaccination was not reported. The patient received Shingrix and had significant increased hair loss. The patient was wondering if hair loss was a reported side effect of the Shingrix vaccine.  The reporter did not see hair loss listed in the prescribing information. The reporter was working with primary care provider and have ruled out everything else, including thyroid dysfunction.
onset at 12hours post injection - Body aches, joint pain, fever, inability to use injection arm (severe soreness), headache, nausea, chills, sweats.   24 hours post injection - body aches, joint pain.
This spontaneous report was received from an allergy technician, concerning a patient of an unknown age and gender. There were no concurrent conditions, medical history, drug reactions, allergies or concomitant medications reported. On an unspecified date, the patient was vaccinated with a dose of GARDASIL 9 injection (dose, frequency and route were not reported) lot # M016193 with expiration date of 24-APR-2018, to treat current Human Papillomavirus (HPV) infection that patient has. No adverse effects were reported. Additional information has been requested.
58 yo male received YF vaccine (lot #UJ819AA) on 7/1/23 no other vaccines administered at that time, although on 5/18 received dose of Twinrix and Shingrix at another pharmacy.  YF vaccine was given in anticipation of an upcoming trip which has not taken place. 7/7 leaves did not leave the city no unusual exposures  7/14 starts feeling unwell and symptoms progress does not seek any medical care 7/23 returns  July 24 goes to local urgent care abdominal pain elevated LFTs referred to ER and subsequently admitted 7/25 Hospital Medical Center On admission 12 days of fever and abdominal pain noted dark urine, white stool, he did recall some diarrhea at the start of his symptoms.  On admission ALT 749 AST 290, AlK Phos 375, bili 3.8.  Elevated WBC (15) diminished Plts 110, Hgb 15.9 Based on imaging studies not felt to be cholecystitis.  Acute hepatitis testing negative for HAV, HBV, HCV, hep E sent out to commercial lab pending. No respiratory sx, mildly elevated create during the hospitalization that resolved.  No bleeding issues normal PT by report.  Reportedly had a bone marrow bx but no liver bx results pending Additional labs Heme WBC 15.9, Plt 118   Porcalcitonin WNL SARS-CoV-2 influenza neg Discharged 8/1 ALT down to 374, AST 204, Alk phos 241, GGT 254patient reports still feels unwell.   PMH  HTN, no hx of immune compromise or thyroid problems No prior YF vaccine
Hospitalization: 1/5/2023 - 1/20/2023 (15 days) Presentation to the ED: upper chest pain COVID + date: 1/20/2023. Treatment: none, patient was discovered positive on a transfer screen to ltcf placement.  Discharge to: SNF 038K20A 2/5/2021 025A21A 3/5/2021 017F21A 10/27/2021 001M21A 4/14/2022 Moderna Bivalent AS7168B 12/16/2022
Within a minute of administration, patient experienced vasovagal syncope.  She was revived within a few minutes and remained for the duration of the 15 minute observation period.  She was accompanied by her sister who cared for her upon departure.  She was able to leave under her own power.
DIZZY; COULD NO LONGER HANDLE TAKING A WALK; FATIGUE; This spontaneous report received from a patient via a company representative concerned a patient of unspecified age and sex. The patient's height, and weight were not reported. No past medical history or concurrent conditions were reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin, and batch number were not reported) dose, start therapy date were not reported for prophylactic vaccination. The batch number was not reported. The Company is unable to perform follow-up to request batch/lot numbers. No concomitant medications were reported.  On an unspecified date, the patient experienced dizzy, could no longer handle taking a walk, and fatigue. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the dizzy, fatigue and could no longer handle taking a walk was not reported. This report was non-serious.