chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Significant hearing problem in left ear / loss of hearing in left ear; Gets loud ringing in the ear; Amplified sounds after taking first dose; A spontaneous report was received from a consumer concerning himself, 79-year-old, patient, who received Moderna's COVID-19 vaccine (mRNA-1273) and experienced significant hearing problem in left ear, loss of hearing in left ear/deafness unilateral, gets loud ringing in the ear/tinnitus, amplified sounds after taking the first dose of the moderna vaccine/ ear disorder.  The patient's medical history was not provided. Concomitant medications reported included acetylsalicylic acid, simvastatin, vitamin D, multivitamin and levothyroxine for product use for unknown indication.  On 28 Jan 2021, prior to the onset of the events, the patient received their first of two planned doses of mRNA-1273 (Lot number: 007M20A) via unknown route in the left arm for prophylaxis of COVID-19 infection. On 25 Feb 2021, the patient received their second of two planned doses of mRNA-1273 (Lot number: 007M20A) via unknown route for prophylaxis of COVID-19 infection. Patient reports that he was scheduled for a brain scan.  On 28 Jan 2021, the patient experienced significant hearing problem in left ear, loss of hearing in left ear, gets loud ringing in the ear, amplified sounds after taking the first dose of the moderna vaccine.   Treatment information was not provided.  The patient received both scheduled doses of mRNA-1273 prior to the event(s); therefore, action taken with the drug in response to the event(s) was not applicable.   The outcome of the event(s), significant hearing problem in left ear, loss of hearing in left ear, gets loud ringing in the ear, amplified sounds after taking the first dose of the moderna vaccine was unknown.; Sender'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.
Thirst, itchy/tingly sensation throat, numbness and tingly sensation in left side of body (including face, arm, leg). Symptoms started 20-30min after vaccine, while I was driving.  3-4hours later numbness was gone; left side still feels "weird". Went to clinic, EMS to the ER and admitted to hospital, discharged the following day in the afternoon.  Discharge Diagnosis: TIA secondary to adverse effect of Moderna vaccine Microangiopathic changes on MRI brain 4/15/2021
Patient was given expired Janssen booster. Vial was punctured 3 days prior but left in refrigerator. Vial was outside the 6 hour window in refrigerator when dose was administered. Additional dose was given the next day per CDC guidance.
12NOV pt got flu w/fever & throwing up & diarrhea; pt taken to MD 2x in 2 days; better w/in wk; then became very hoarse, fever 101.7 MD said, bronchitis given meds, got worse could not breath to hosp w/t104-croup;
sore to the touch; Dark spot at the injection site,; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE RASH (Dark spot at the injection site,) and VACCINATION SITE PAIN (sore to the touch) in a 76-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 007B21A) for COVID-19 vaccination.     No Medical History information was reported.    On 11-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 11-Mar-2021, the patient experienced VACCINATION SITE RASH (Dark spot at the injection site,). On an unknown date, the patient experienced VACCINATION SITE PAIN (sore to the touch). Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       This case was linked to MOD-2021-116362 (Patient Link).
This spontaneous report as received from a medical assistant refers to an unspecified number of patients of unknown age. On an unknown dates the patients were vaccinated with a dose of improperly stored GARDASIL (dose, route of administration, lot number were not reported). There was no adverse effects reported. Product Quality Complaint (PQC) was not involved. Additional information has been requested.
headaches; tiredness; muscle and joint pain; muscle and joint pain; Taste is gone- he cannot taste anything; fever; Injection site is red- big red mark; couldn't walk; chills; not feeling well and really hurting; not feeling well and really hurting; This is a spontaneous report from a contactable consumer or other non-healthcare professional.   An 81-years-old male patient received bnt162b2 (BNT162B2, PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection), dose 1 via an unspecified route of administration, administered in Arm Left on 06Mar2021 11:30 (Batch/Lot number and Expiration date was not reported) (at the age of 81-years-old) as dose 1, single for covid-19 immunisation. Medical history included atrial fibrillation (Verbatim: A-fib, had that for 30 years, reported just a little bit of a heart condition) and covid-19 (reported that he had the covid in September, but he healed and got over it. No additional information provided). Concomitant medications included acetylsalicylic acid (ASPIRIN (E.C.)); furosemide (LASIX [FUROSEMIDE]), Start, stop date and dosing regimen details of concomitant medications were not reported (reports he is on so many medications. He clarified he is on 19 different medications. And mentioned Aspirin and Lasix. No additional information was provided). The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. There were no adverse events reported prior to previous vaccinations. There was no relevant family history reported. On 08Mar2021, when he woke up (exact time unknown), the patient experienced headaches, tiredness, muscle and joint pain, taste gone, fever, chills, Injection site is red- big red mark and couldn't walk. On an unspecified date in 2021, the patient experienced not feeling well and really hurting. The reporter called for guidance about what to do after he experienced symptoms for the administration of the Pfizer's COVID-19 vaccine. It was reported that he was administered with the Pfizer's COVID-19 vaccine on Saturday 06Mar2021, and he experienced headaches, tiredness, muscle and joint pain, the taste gone, fever and chills and redness in the injection site. Laboratory tests on an unspecified date included body temperature: unknown results (fever). The events did not result in emergency room or physician office visit. The patient reported that he goes to the doctor every month and he has blood tests done every month to see what's going on with his body. Also reported that he waited on the phone for a half hour, and he was not feeling well and really hurting, and wants his question answered. There were no relevant tests performed. The clinical outcome of the event not feeling well and really hurting was unknown and all other events was not recovered.  No follow-up attempts are possible. Information about lot/batch number cannot be obtained.
Acute onset fever & chills, starting with warm/febrile feeling, then shaking rigors, unable to hold glass of water & unable to keep glass thermometer in mouth for fear of biting it--rigors affecting entire body including teeth-chattering. Myalgias & headache followed shortly after.  Very poor sleep all night. During night, rigors improved and then stopped, though I then felt very cold. Next am (4/16, 07:30 am), febrile to 101 (able to use thermometer, rigors gone), moderately severe headache, diffuse myalgias, severe fatigue & "brain fog," called in sick to work. Fevers continued through day, down to 99.8 by bedtime, but persistent headache & myalgias. This morning, 4/17, afebrile, headache & myalgias much improved but still present at low level. I have never had any reaction like this to any vaccine that I can recall, other than one mildly febrile response to one flu vaccine many decades ago.
This spontaneous report was received from a health care professional refers to multiple unspecified patients of unknown demographics. On unspecified dates the patients were vaccinated with improperly stored GARDASIL 9 (dosing regimen unspecified) (L020015, expiration 16-AUG-2017). Excursion details are as follows: temperature: 32F, time frame: 24 hours, there was no previous temperature excursion. It was back in range. It was a call because of a data logger. No adverse effect reported. Call disconnected before any additional information was obtained. No additional information was provided. This is one of the two reports from the same reporter. Additional information has been requested.
pt reported h/a about 10PM & 11PM vomited 3x during noc;14AUg today reports5-6 times dry heaves;stiff from head to toe & having chills, lt arm sore where shot given;14AUG97 went to MD on ATB pt reports feel bacterial infect;
Admitted and started on antibiotics for left groin infection; COVID-19+, tx w/remdesivir, O2, steroids, abx; weaned to RA for dc home.
39 degrees celsius fever; Based on the current case data, this case has been classified as invalid. This spontaneous case was reported by a consumer and describes the occurrence of PYREXIA (39 degrees celsius fever) in a patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced PYREXIA (39 degrees celsius fever). At the time of the report, PYREXIA (39 degrees celsius fever) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, Body temperature: 39 (High) 39 degrees celsius.     The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No concomitant medication reported. No treatment medication reported.   Reporter did not allow further contact
Tolerated vaccine well. 2 days after vaccine, patient fell several times while playing.  Patient  then c/o pain in affected leg, and for a brief time could not bear weight at all. After resting for a short time, was able to bear partial weight. Afebrile, no visible swelling, no known injury to area. He recovered within a few hours of rest and after taking Motrin. He fell again once early the next morning, but did not c/o pain at that time. He also woke up with mild cold symptoms that morning.  No further issues, and was able to bear weight normally. Since issue resolved on its own with symptomatic treatment, did not have him seen by a doctor.
Patient had cramps (also currently on period), hot but not a fever, and sore arm. Patient ok for now and I will follow up with patient next week
After an 1 1/2 hour itching started all over the body. I have the itch for 4 days now, skin is drying out on hand and feet. Went to seek medical assistant, coworker said to seek assistance from Occupational health.
Initial unsolicited case received from consumer via social media on 10-Oct-2016. This case is linked to 2016SA188144, 2016SA188556, 2016SA188803, 2016SA188805, 2016SA188806, 2016SA188807, 2016SA188808, 2016SA188809, 2016SA188810, 2016SA188811, 2016SA188812, 2016SA188813, 2016SA188814, 2016SA188815, 2016SA188816, 2016SA188817, 2016SA188818, 2016SA188819, 2016SA188820, 2016SA188821, 2016SA188822, 2016SA188833, 2016SA188834, 2016SA188835, 2016SA188836, 2016SA188837, 2016SA188838, 2016SA188839, 2016SA188840, 2016SA188841, 2016SA188842, 2016SA188843, 2016SA188844, 2016SA188845, 2016SA188846, 2016SA188847, 2016SA188848, 2016SA188849, 2016SA188850, 2016SA188851. (Same source, same vaccine). This case involves a patient (age and gender not reported) who was vaccinated with a dose of FLU SHOT (manufacturer: unknown, batch number, expiry date, route and site of administration: not reported) on an unspecified date. It was reported that, patient also had Influenza vaccine earlier on an unspecified date and got sick. Patient's medical history and concomitant medications were not reported. On an unspecified date, post vaccination, the patient was "dick" (sick). Patient's lab data and corrective treatment was not reported. The outcome of the events was not reported.  List of documents held by sender: none.
itchiness on her neck, stomach and legs/Itchiness on her legs; scabs on her neck and stomach; feeling tired; This spontaneous case was reported by a consumer and describes the occurrence of PRURITUS (itchiness on her neck, stomach and legs/Itchiness on her legs), SCAB (scabs on her neck and stomach) and FATIGUE (feeling tired) in a 77-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 025J20A) for COVID-19 vaccination.     The patient's past medical history included No adverse event (No reported medical history.).    On 23-Dec-2020, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 04-Jan-2021, the patient experienced PRURITUS (itchiness on her neck, stomach and legs/Itchiness on her legs), SCAB (scabs on her neck and stomach) and FATIGUE (feeling tired). At the time of the report, PRURITUS (itchiness on her neck, stomach and legs/Itchiness on her legs) and SCAB (scabs on her neck and stomach) had resolved and FATIGUE (feeling tired) outcome was unknown.        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.   Treatment for the event included diphenhydramine, rubbing alcohol, and hydrocortisone cream.  Based on the current available information and temporal association between the use of the product and the start date of the event, a causal relationship cannot be excluded.   Most recent FOLLOW-UP information incorporated above includes: On 08-Jan-2021: No specific follow-up information recorded.; Reporter's Comments: Based on the current available information and temporal association between the use of the product and the start date of the event, a causal relationship cannot be excluded.
w/in 13-15 p/vax pt c/o vertigo, slowly devel tightness in throat, diff swallowing, numbness feet & hands;BP 118/62, P88, R28;given med sz persisted;911 called;epi given;
TC fr mom-states ok day of immun on 17APR91 woke up w/temp 102 & refusal to move rt arm; refuses to eat; arm inc redness & swelling; Given APAP q4hrs; Referred to MD;
Developed generalized hives, but very few in number.  Initially pruritic, but this resolved with use of steroid cream (over the counter), no wheezing, no respiratory symptoms.
I21.4 ACUTE NON ST ELEVATION MI 3/22/2023 CHEST PAIN I21.4 ACUTE NON ST ELEVATION MI 3/22/2023 HX OF CABG
hives on arms, hands, back of neck, and legs; 03/02/21 took 2 Benadryl  03/03/21 received IV Benadryl at dialysis 03/05/21 got topical cream from PCP (while there for normal check-up)
Patient was nervous about the vaccination. About 5 minutes after vaccination patient got up from waiting area to ask for water and fainted, fell and hit her head. EMS was immediately called, arrived shortly and transported patient.
dizziness; extreme fatigue/fatigue; Sore arm at injection site; dull headache; This is a spontaneous report from a contactable Other-HCP reporting for self. A 49-year-old female patient received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Lot number: EL1283), intramuscular on 14Jan2021 08:30 at single dose for COVID-19 immunization.  Medical history was not reported. There were no concomitant medications.  The patient experienced on 14Jan2021 09:00 Sore arm at injection site, dull headache day of injection, 2 days later extreme fatigue. 4 days later dizziness and fatigue that lasted 2 days. Outcome of events was recovered.
Pt received Menactra on 10/12/05.  pt given second dose of Menactra on 02/20/07.
Information has been received from a nurse concerning a female who in November 2007, was vaccinated with the first dose of Gardasil.  Subsequently, the patient experienced localized reaction at the injection site consisting of redness, warmth, and itching.  Unknown medical attention was sought.  The reaction resolved completely (date unknown).  No product quality complaint was involved.  Additional information has been requested. This is  in follow-up to report(s) previously submitted on 2/14/2008.  Information has been received from a nurse concerning a 19 year old female who with very sensitive to medication, on 19-November 2007, was vaccinated in the left deltoid with the first dose of GARDASIL (lot# 658219/0755U).  On 11-Jan-2008 she received the second dose in the right deltoid (lot# 658219/0755U).  Two hours after the first dose, shot site became red with swelling.  Two weeks after the vaccination the patient experienced nausea and vomiting.  Two weeks after the second vaccination the patient experienced nausea and vomiting.  Unknown medical attention was sought.  The patient was recovered.  No product quality complaint was involved.  Additional information has been requested.
pt revd vax; pt devel rash which was dx as lupus erythematosis;
Diarrhea, resulting in severe diaper rash and bloody sores on bottom.  This lasted for approximately 48 hours. Small red spots also appeared all over body, but disappeared in 24 hours.
felt the injection needle pinch his arm.; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE PAIN (felt the injection needle pinch his arm.) in a 79-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 013L20A and 013L20A) for COVID-19 vaccination.     No Medical History information was reported.   On 22-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 22-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 22-Feb-2021, the patient experienced VACCINATION SITE PAIN (felt the injection needle pinch his arm.). At the time of the report, VACCINATION SITE PAIN (felt the injection needle pinch his arm.) outcome was unknown.            No Concomitant information was reported. No Treatment information was reported.   This case was linked to MOD-2022-509755, MOD-2022-509820 (Patient Link).
History of right stage Ia breast cancer 2 mm hormone positive treated with breast conservation therapy completed October 2019 and was placed on tamoxifen (due to history of osteonecrosis of the jaw aromatase inhibitor was avoided)  15 March 2021 due to some left shoulder pain a CT angiogram showed acute bilateral lower lobe segmental PE occlusive at anterior left lower lobe with small left lower lobe infarct, no RV strain, tamoxifen was discontinued 15 March 2021 bilateral lower extremity ultrasounds were negative She was treated with heparin and transition to warfarin due to cost, and then after financial assistance she was switched to Eliquis  Of note she had Pfizer Covid vaccines 24 February and 19 March 2021, in addition she had the tamoxifen and age as likely risk factors, no family history of blood clots, and no current active cancer at this time
I developed a terrible rash all over my body.  Went to walk-in clinic and then was referred to dermatologist.  I was on Prednisone 20mg/day for 2 months; did not resolve it.  Then used 5% steroid cream and Hydorxyzine 10 mg pills.  Then had to increase cream to 14% solution.  The rash would come and go on different parts of my body, never completely going away.  The rash has much improved, but a year later, it has not completely gone away; I use the cream only on the spots as they appear.  Then in August of 2021, I was badly sunburned while in Hawaii.  After I got home, I developed horrible blisters and was diagnosed with bullous pemphigoid.  I was on Prednisone for 4 months, starting with 40 mg/day and weaning down to 10 mg/day.  Even though you can still see the spots where the blisters were, they have not filled with liquid since my treatment, and I am considered to be in remission.
painful arm, and hand; swollen arm and hand; difficult for her to move her hand; This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (painful arm, and hand), PERIPHERAL SWELLING (swollen arm and hand) and MOBILITY DECREASED (difficult for her to move her hand) in a 69-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 007C21A) for COVID-19 vaccination.     No medical history was provided by the reporter.     On 05-May-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 08-May-2021, the patient experienced PAIN IN EXTREMITY (painful arm, and hand), PERIPHERAL SWELLING (swollen arm and hand) and MOBILITY DECREASED (difficult for her to move her hand). At the time of the report, PAIN IN EXTREMITY (painful arm, and hand), PERIPHERAL SWELLING (swollen arm and hand) and MOBILITY DECREASED (difficult for her to move her hand) had resolved. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Relevant concomitant medications were reported i.e., Thyroid Medication, Glaucoma Medication.  Treatment details are provided i.e., Excedrin, Tylenol, Soak.  Reporter stated she had both doses and she is fine.   Most recent FOLLOW-UP information incorporated above includes: On 08-Jun-2021: Followup was received on 08-Jun-2021. Added dose 2 information. Updated action taken for suspect drug and outcome of events.
Pt called in only to report side effects that occurred 2 weeks ago.  Reports 24hrs after 1st dose Pfizer bilateral arm soreness, itchiness, bilateral swelling of ears, ""felt like ears were aching."" Neck, shoulder and back stiffness. States she took tylenol and benadryl with no improvement. States has a history of allergic reactions to vaccines, but unsure which vaccines, ""never figured it out."" Has been 8 years since last allergic reaction. Pt spoke with outside PCP and will calll again to reschedule dose 2 appt. NO ER sxs at time of call.
patient's were administered the IPOL (opened) after the excursion; Initial information received on 20-Dec-2022 regarding an unsolicited valid non-serious case received from a other health professional.  This case involves a 12 years old female patient who experienced patient's were administered the ipol (opened) after the excursion while receiving vaccine poliomyelitis vaccine (inactivated) (ipv (vero)) [ipol].  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.   On an unknown date, the patient received a dose of suspect poliomyelitis vaccine (inactivated) Suspension for injection (strength, frequency, dose, expiration date, lot number not reported) via unknown route in unknown administration site for prophylactic vaccination.  On an unknown date the patient developed a non-serious patient's were administered the ipol (opened) after the excursion (poor quality product administered) (unknown latency).  Lab data was not reported.  Action taken was not applicable.  Corrective treatment was not reported for the event.  Outcome was Unknown for the event.  This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holder's compliance with the requirements set out in the Directive 2001/83/EC and Module VI of the Good Pharmacovigilance Practices. The classification as a medical error is in no way intended, nor should it be interpreted or construed as an allegation or claim made by the marketing authorization holder that any third party has contributed to or is to be held liable for the occurrence of this medication error.
Accelerated heart rate, dizziness, nausea, and shortness of breath during minor physical activity